Chapter 1 – Overview of the WTC Health Program

1. Purpose and Scope

The purpose of the World Trade Center Health Program (WTC Health Program or the Program) Administrative Manual is to document the policies and procedures that provide the comprehensive framework for administering the Program. The audience for the PPM is internal staff, WTC Health Program support groups, and the public. The PPM will be updated regularly.

The purpose of this chapter is to provide a general overview of the WTC Health Program, including a brief description of the history and origins of the Program, a summary of the guiding legislation, and a description of the organization that has been developed to carry out the provisions of the legislation.

2. Statutory and Regulatory References

The Program is established by Public Law 111-347, the James Zadroga 9/11 Health and Compensation Act of 2010 (the Zadroga Act). Title I of the Zadroga Act amended the Public Health Service (PHS) Act to add Title XXXIII, establishing the WTC Health Program within the Department of Health and Human Services. Title XXXIII of the PHS Act is codified at 42 U.S.C. §§ 300mm – 300mm-61. Program regulations were promulgated in Title 42, Part 88 of the Code of Federal Regulations (C.F.R.). Descriptions of the major provisions of the Zadroga Act and the Part 88 regulations are set forth in Section 4 below.

3. History of the WTC Health Program

Since the terrorist attacks of September 11, 2001, the U.S. Department of Health and Human Services (HHS), the Centers for Disease Control and Prevention (CDC) and the National Institute for Occupational Safety and Health (NIOSH) have facilitated health evaluations and screenings for individuals who responded to those attacks in order to identify any health issues resulting from their exposures in the aftermath of the attacks.

1. The first such program began in 2002 with grants funded via discretionary appropriations and awarded to the Mount Sinai School of Medicine (Mount Sinai) and the Fire Department of the City of New York (FDNY) to provide health screening. Mount Sinai subcontracted with specialized occupational health clinics in the New York City (NYC) metropolitan area, developing a standardized health screening protocol.
2. In 2003, the program was expanded to provide periodic monitoring examinations in addition to the initial health screenings. The individual clinics providing the screening and monitoring examinations were funded through cooperative agreements between NIOSH and Mt. Sinai and FDNY.
3. In 2006, diagnostic and treatment services were added to provide medical care for WTC-related occupational health conditions. The program was called the WTC Medical Monitoring and Treatment Program (MMTP). The program medical providers were individually funded as Clinical Centers of Excellence (CCEs) and included Mt. Sinai Medical Center, New York University School of Medicine-Bellevue Hospital Center, Queens College, Richmond University Medical Center, State University of New York (SUNY)-Stony Brook, and University of Medicine and Dentistry of New Jersey. Services were made available outside the NYC metropolitan area through a network of providers via a contract with Logistics Health, Incorporated (LHI).
4. In 2008, additional funds were appropriated to provide screening, diagnostic, and treatment services to residents, students, and others who were affected by the September 11, 2001 attacks in NYC, under the WTC Environmental Health Center (EHC) Community Program, operated under a CDC-sponsored grant to the NYC Health + Hospitals Corporation.
5. On January 2, 2011, the President signed the James Zadroga 9/11 Health and Compensation Act into law, establishing the WTC Health Program within the Department of Health and Human Services.

4. Summary of the James Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-347

1. The WTC Health Program was mandated to begin on July 1, 2011. Only services provided on and after that date are covered by the WTC Health Program [PHS Act, § 3301(a); 42 C.F.R. Part 88]. The Program is required to provide:
1. Medical monitoring and treatment benefits to eligible emergency responders and recovery and cleanup workers who responded to the September 11, 2001 terrorist attacks in NYC, Shanksville, PA, and the Pentagon [PHS Act, §§ 3301(a)(1), 3301(b)(1), and 3301(b)(3)]; and
2. Initial health evaluation, monitoring and treatment benefits to eligible residents and other building occupants and area workers in NYC who were directly impacted by the attacks [PHS Act, §§ 3301(a)(2), 3301(b)(2) and 3301(b)(3)].
3. These services are provided at no cost to the enrolled members; there is no cost-sharing [PHS Act, § 3301(c)].


2. WTC Program Administrator. The Administrator of the WTC Health Program administers the WTC Health Program. The PHS Act directs the Secretary of HHS to designate a Department official to be the WTC Program Administrator [PHS Act, § 3306(14)]. Certain specific activities of the Administrator are reserved to the Secretary to delegate at her discretion; other duties of the Administrator not explicitly reserved to the Secretary are specifically assigned to the Director of NIOSH or his or her designee. The Secretary has designated the Director of NIOSH to also serve as the WTC Program Administrator for the discretionary activities; the Secretary delegated responsibilities for disbursing payments to providers under the WTC Health Program to the Centers for Medicare & Medicaid Services (see Delegation of Authority, 76 Fed. Reg. 31337, May 31, 2011). Specific duties of the Administrator include:
1. Establish an enrollment process for eligible responders and screening-eligible survivors [PHS Act, §§ 3311(a)(3) and 3321(a)(1)(C); 42 C.F.R. §§ 88.4 and 88.8];
2. Establish end-dates for Pentagon and Shanksville responder eligibility [PHS Act, § 3311(a)(2)(C)(i) and (ii); 42 C.F.R. § 88.4(b) and (c)];
3. Establish a process for the certification of health conditions [PHS Act, §§ 3312(b)(1)(B) and 3321(a)(2)(B); 42 C.F.R. § 88.13];
4. Add new health conditions to the List of WTC-Related Health conditions via rulemaking [PHS Act, § 3312(a)(5) and (6); 42 C.F.R. § 88.17];
5. Establish a medical necessity standard [PHS Act, § 3312(b)(3); 42 C.F.R. § 88.14];
6. Establish a quality assurance program to ensure adherence to monitoring and treatment protocols, appropriate diagnostic and treatment referrals, prompt communication of test results to participants, and other programmatic elements the Administrator finds necessary [PHS Act, § 3301(e)];
7. Submit annual report to Congress, including statistics on eligible individuals; costs of monitoring, screening, and treatment; administrative costs; administrative experience; summary of new scientific reports or studies that address WTC-related exposures; and WTC Health Program Scientific/Technical Advisory Committee recommendations and Administrator’s actions on those recommendations [PHS Act, § 3301(f)].


3. WTC Responder Enrollment and Eligibility. The PHS Act establishes eligibility criteria for New York City responders [PHS Act, § 3311(a)(1) and (2); 42 C.F.R. § 88.4(a)], Pentagon responders [PHS Act, § 3311(a)(2)(C); 42 C.F.R. § 88.4(b)], and Shanksville responders [PHS Act, § 3311(a)(2)(C); 42 C.F.R. § 88.4(c)]. Eligibility is limited by the number of responders already enrolled in the Program [PHS Act, § 3311(a)(4); 42 C.F.R. § 88.6(c)(2)(i)] and by membership on the terrorist watch list [PHS Act, § 3311(a)(5); 42 C.F.R. § 88.6(c)(3)].


4. WTC Survivor Enrollment and Eligibility. The PHS Act establishes eligibility criteria for New York City screening-eligible survivors [PHS Act, § 3321(a)(1)(C); 42 C.F.R. § 88.8(a)] and certified-eligible survivors [PHS Act, § 3321(a)(2); 42 C.F.R. § 88.8(b)]. The PHS Act requires that initial health evaluations are provided at no charge by a Clinical Center of Excellence to determine if the screening-eligible survivor has a WTC-related health condition [PHS Act, § 3321(b)]. Eligibility is limited by the number of certified-eligible survivors already enrolled in the Program [PHS Act, § 3321(a)(3); 42 C.F.R. §88.10(f)(2)(i)] and by membership on the terrorist watch list [PHS Act, § 3321(a)(4); 42 C.F.R. § 88.10(f)(3)].


5. WTC Health Program Scientific/Technical Advisory Committee (STAC). The STAC is established by the Administrator of the WTC Health Program, with a specified, diverse membership. The meeting frequency of the STAC is discretionary. Reports of the STAC are to be published on the WTC Health Program website [PHS Act, § 3302(a)].


6. WTC Health Program Steering Committees. The PHS Act establishes two steering committees -- one for WTC responders, and another for WTC survivors [PHS Act, § 3302(b)]. Each of these committees establishes a forum for providing input from affected stakeholders and for facilitating the coordination of services for eligible individuals. Each has specific requirements for membership, and was initially composed of members of steering committees that were in existence as of the date the Zadroga Act was signed into law. The steering committees appoint their own members, and the WTC Program Administrator is to consult with the two committees.


7. Certification of Health Conditions. An initial list of WTC-related health conditions is established by the PHS Act [PHS Act, §§ 3312(a)(3) and 3322(b); 42 C.F.R. § 88.1]. The WTC Health Program is required to certify WTC-related health conditions for treatment and monitoring [PHS Act, §§ 3312(b)(1)(B)(ii) and 3321(a)(2)(B); 42 C.F.R. § 88.13] after a Program physician determines that exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition [PHS Act, § 3312(a)(1)(A)(i); 42 C.F.R. § 88.12] or is a mental health condition for which a Program physician finds that the terrorist attacks are substantially likely to be a significant factor in aggravating, contributing to, or causing [PHS Act, §3312(a)(1)(A)(ii)]. The health condition must be included on the List of WTC-Related Health Conditions [PHS Act, § 3312(a)(1)(B); 42 C.F.R. §88.1] or must be identified as a health condition medically associated with a WTC-related health condition [PHS Act, § 3312(a)(1)(B)(i) and (ii); 42 C.F.R. §§ 88.1 and 88.12(b)]. Denials of certification may be appealed [PHS Act, §§ 3312(b)(1)(B)(iii), 3312(b)(2)(B)(iv), and 3312(b)(3)(B); 42 C.F.R. § 88.15].


8. Medical Benefits. The PHS Act establishes that the scope of treatment covered by the Program includes services of physicians and other healthcare providers, diagnostic and laboratory tests, prescription drugs, inpatient and outpatient hospital services, and other medically necessary treatment [PHS Act, § 3312(b)(4)(A)]. The Program may approve the provision of medical treatment until a determination is made to certify the health condition [PHS Act, § 3312(b)(5)].


9. Claims Processing and Billing. Benefits under the WTC Health Program for work-related health conditions are to be offset by workers’ compensation benefits, except for those plans to which NYC is obligated to make payments. WTC Health Program benefits do not absolve other workers’ compensation, injury or illness, or health insurance plans of their obligations regarding payment of claims for medical treatment of Program members [PHS Act, §§ 3331 and 3351]. Payments for initial health evaluation, monitoring, and treatment are to be made using the rates applicable under the Federal Employees’ Compensation Act (FECA) regulations in 20 C.F.R. Part 20. If no FECA rate is available, the WTC Health Program may establish a payment rate by regulation. Payment rates may not exceed the rate the Office of Worker’s Compensation Programs in the Department of Labor would pay for such products or services at the time they were provided [PHS Act, § 3312(c)(1)(A); 42 C.F.R. § 88.16].


10. Data Centers. The PHS Act requires the Administrator to enter into contracts with the Data Centers to: receive, analyze, and report data from the CCEs to the WTC Health Program Administrator; develop Program monitoring, treatment, and initial health evaluation protocols; coordinate outreach activities with the CCEs; establish criteria to credential medical providers participating in the Program; coordinate and administer the activities of the WTC Health Program Steering Committees; and meet with the CCEs for input on data collection and analysis and medical protocols [PHS Act, § 3305(a)(2)].


11. Clinical Centers of Excellence (CCEs). The PHS Act requires the Administrator to enter into contracts with the CCEs to: provide monitoring, treatment, and initial health evaluation benefits; conduct outreach to eligible and enrolled individuals; provide counseling regarding benefits available under the WTC Health Program and other programs; provide translational and interpretive services for non-English-proficient participants; and collect and report data [PHS Act, § 3305(a)(1)]. The definition of and contract requirements for CCEs, as well as transition requirements for continuity of care are also provided [PHS Act, § 3305(b)].


12. Nationwide Provider Network. The PHS Act requires the Administrator to establish a nationwide network of healthcare providers to provide monitoring and treatment benefits and initial health evaluation near such individuals’ areas of residence in such states [PHS Act, § 3313(a)]. Any healthcare provider participating in the network is required to meet criteria for credentialing established by the Data Centers; following Program treatment protocols; collect and report data; and meet fraud, quality assurance, and other Program requirements [PHS Act, § 3313(b)].


13. Member Services. The PHS Act requires the development of an outreach program to provide information to potentially eligible individuals regarding benefits, clinical data collection and analysis, and research on health conditions resulting from the terrorist attacks [PHS Act, §§ 3301(b)(4) and 3303]. Outreach must include a public Website, meetings with potentially eligible persons, development and distribution of outreach materials, and telephone information services. The services must be carried out in such a way as to reach all affected populations, and include materials for culturally and linguistically diverse populations [PHS Act, § 3303].


14. Governmental Affairs. The HHS Inspector General is required to conduct reviews of the healthcare and administrative expenditures under the Program to detect potential fraudulent or duplicate billing, payment for inappropriate services, or unreasonable administrative costs [PHS Act, § 3301(d)].


15. Pharmacy Benefits. Pharmacy prescription benefits are to be paid through contracts with outside vendors, using a competitive bidding process. A separate contract may be used for FDNY participants [PHS Act, §§ 3312(b)(4)(B) and 3312(c)(1)(B)].

5. Organization

1. The WTC Health Program is administered by NIOSH, which is part of CDC within HHS. NIOSH offices in Washington, DC, Atlanta, GA, Cincinnati, OH, and Pittsburgh, PA are involved in the program. NIOSH is responsible for overall program policy, management, and oversight, and carries out certain functions, such as certification of enrollments, certification of health conditions, and appeals. The work of the WTC Health Program is carried out through teams comprised of NIOSH and contractor employees. Contractors currently include the Program Management and Administration (PM&A) contractor, CSC; CCEs; DCs; and the National Provider Network (NPN) contractor, LHI. In addition, NIOSH and the PM&A contractor interface with the Centers for Medicare and Medicaid Services (CMS) and its payment contractor in the hand-off of a payment file for payment of authorized claims.


2. Major teams supporting the Program’s administration functions are:
   1. Health Plan Operations
   2. Member Services
   3. Medical Benefits
   4. Contracts and Claims
   
   
3. The PM&A contractor (CSC) is responsible for the day-to-day operations of the WTC Health Program, including developing and executing Program infrastructure and technical support. The contractor maintains a mailroom for the receipt and distribution of paper-based communications in Rensselaer, NY; member services (enrollment, certification, and communications) and other administrative functions are located in metropolitan Washington, DC; claims processing takes place in Atlanta, GA; and a call center is located in Fort Worth, TX. Contacts to any of these services may be made through the call center at 1-888-WTC-HP4U (1-888-982-4748).


4. The CCEs and the NPN contractor (LHI) provide face-to-face assistance and services to enrolled members and potential members. They assist with completing enrollment forms, provide medical monitoring, screening, and treatment services, and make referrals to enrolled medical providers for some medical services. They also take part in establishing program guidelines, oversee medical treatment, and submit claims for medical reimbursement. There are six (6) CCEs in NYC, as well as the NPN contractor for services outside the NYC Metropolitan Area. A list of the CCEs, as well as contact information for them and the NPN contractor, may be found at https://www.cdc.gov/wtc/clinics.html.


5. There are three DCs providing the services described in section 4.M above, the Icahn School of Medicine at Mt. Sinai, Health + Hospitals Corporation (Bellevue Hospital), and FDNY.


6. Medical providers other than the CCEs may take part in the WTC Health Program only if they have been enrolled in the program as an eligible provider through a CCE or the NPN.

Chapter 2 - Eligibility and Enrollment

1. Purpose and Scope

The purpose of this chapter is to provide a description of the eligibility requirements for enrollment in the WTC Health Program, of the processes for determining eligibility under the WTC Health Program, and the processes for enrolling members. Eligibility requirements, instructions, and applications can be found at: https://www.cdc.gov/wtc/apply.html.

2. Statutory and Regulatory References

Procedures for the determination of eligibility and enrollment of WTC Health Program members are guided by the following sections of Title XXXIII of the Public Health Service Act (Act):

• Section 3311, Identification of WTC Responders and Provision of WTC-Related Monitoring Services; and
• Section 3321, Identification and Initial Health Evaluation of Screening-Eligible and Certified-Eligible WTC Survivors.

Program eligibility criteria are established in the following sections of 42 C.F.R. Part 88:

• Section 88.3, Eligibility--currently identified responders;
• Section 88.4, Eligibility criteria--WTC responders;
• Section 88.5, Application process--WTC responders;
• Section 88.6, Enrollment decision--WTC responders,
• Section 88.7, Eligibility--currently identified survivors;
• Section 88.8, Eligibility criteria--WTC survivors;
• Section 88.9, Application process--WTC survivors;
• Section 88.10, Enrollment decision--screening-eligible survivors;
• Section 88.11, Initial health evaluation for screening-eligible survivors;
• Section 88.12, Enrollment decision--certified-eligible survivors; and
• Section 88.13, Disenrollment.

3. Responsibilities

Many parts of the WTC Health Program have responsibilities related to eligibility and enrollment in the Program.

1. Clinical Centers of Excellence (CCEs) are responsible for providing information on responders and survivors enrolled in the WTC predecessor programs [WTC Medical Monitoring and Treatment Program (MMTP) and the WTC Environmental Health Center (EHC) Community Program] so that the members may be enrolled in the WTC Health Program and continuity of care ensured. The CCEs also provide support for enrollment of new members in the WTC Health Program through outreach programs, education, and assistance to potential applicants completing the enrollment forms.
2. Data Centers (DCs) are responsible for processing all new members into the appropriate cohort (responder or survivor). Once an applicant is determined to be eligible, his/her name is added to the list of new enrollees that the Health Program Support (HPS) contractor sends to the DC each week. The DC inputs new enrollees into its database. The Mount Sinai School of Medicine (MSSM) DC which services the responder program [except for Fire Department of New York City (FDNY) responders who receive services through the FDNY CCE and DC] will also include the CCE selection made by the member and will notify the CCE of the new member that has been assigned to its clinic.
3. The Nationwide Provider Network (NPN), administered by Logistics Health Incorporated (LHI), is the WTC Health Program’s provider network for members living outside of the New York (NY) metropolitan area, including those from Shanksville, PA and Arlington, VA (the site of the Pentagon). The NPN received from the Program a list of responders living outside of the NY metropolitan area who were in the predecessor WTC MMTP, and receives weekly updates on NPN enrollees from the HPS contractor. After receiving the list of new NPN enrollees, the NPN enters the members into its system and reaches out to the new members to educate them regarding NPN processes for obtaining covered benefits.
4. The Business Services Outsourcing Center (BSOC), part of the HPS contractor’s organization, scans the enrollment forms and any attachments sent with the application, and assigns a Document Control Number (DCN) to each.
5. The WTC Health Program HPS contractor receives new enrollment applications, captures information in the claims processing system, examines the enrollment packages for completeness, requests additional information as needed, and makes referrals to the Program’s Member Services Team for the final enrollment certification decisions. After the Member Services Team has made a final decision to approve, the HPS contractor sends notification of approval to the applicant and to the correlating DC or, when the enrollee lives outside the NY metropolitan area, the NPN. When a member is determined to be eligible, the HPS contractor sends out welcome packages and follows up with the new enrollees to select a CCE. If an applicant is determined not to be eligible for the Program, the applicant receives a letter explaining why enrollment was denied and is provided an opportunity to appeal. In addition, during the initial implementation of the WTC Health Program, the HPS contractor worked with the DCs and CCEs to enroll the previously enrolled (grandfathered) members in the Program.
6. The Program’s Member Services Team reviews the finalized enrollment packages and, after the clearance of the applicant again the Terrorist Watch List (TWL), makes the final eligibility decision. For all eligibility denials, the Member Services lead will review the denial package and letter to approve the reason(s) for denial before replying to the applicant. The Program also processes any appeals of enrollment decisions.

4. Overview – Eligibility and Enrollment

1. Eligibility

   The PHS Act identifies multiple member groups eligible to participate in the WTC Health Program. Membership groups include: responders from the Fire Department of New York City (FDNY); other specified New York responders; New York survivors; surviving immediate family members of the 343 FDNY responders who perished on September 11, 2001; Pentagon responders; and Shanksville, PA responders.

   Some responders and survivors were enrolled in predecessor programs prior to the start date of the WTC Health Program (July 1, 2011). Responders who were enrolled with FDNY or the MMTP prior to July 1, 2011 and survivors who were enrolled in the EHC Community Program prior to January 2, 2011 were automatically enrolled (following Terrorist Watch List screening) in the WTC Health Program. These members were enrolled in batches.

   Responders and survivors who newly enroll in the WTC Health Program on or after July 1, 2011, and survivors who enrolled in the predecessor program between January 2, 2011 and June 30, 2011, are required to use the WTC Health Program Office of Management and Budget (OMB)-approved application forms to enroll in the Program. The application forms are specific to each member group, and describe the criteria necessary to qualify for the Program. FDNY responders, general New York responders, Pentagon and Shanksville responders, and survivors each have a distinct application form that is unique to the eligibility requirements for each group. These forms may be found in Appendices 2-A through 2-D.

   The “responder” member group of surviving immediate family members of the 343 FDNY responders who perished on September 11, 2001 is generally considered to be a closed group; however, if someone believes s/he is eligible for this cohort, that person may use the FDNY responder application and complete the appropriate sections (Appendix 2-A). Because of the Supreme Court decision in U.S. v. Windsor, 133 S.Ct. 2675 (2013), striking down Section 3 of the Defense of Marriage Act, there may be individuals who were in same-sex marriages as of September 11, 2001, who are newly eligible for certain benefits within the WTC Health Program. The WTC Health Program is also extending this eligibility to certain persons who were in same-sex or opposite-sex domestic partnerships as of September 11, 2001. Specifically, an applicant may be eligible if s/he (a) were in a same-sex marriage (see the following paragraph), civil union, or domestic partnership, with a member of the FDNY who was killed at the WTC site on September 11, 2001; and (b) received any treatment for a WTC-related mental health condition on or before September 1, 2008.

   For purposes of eligibility, the WTC Health Program recognizes a same-sex marriage or civil union if it was legally valid under the laws of the state or other jurisdiction, whether foreign or domestic, when and where the marriage or civil union was performed. The WTC Health Program follows this approach regardless of where the couple lived on September 11, 2001. In addition, the WTC Health Program recognizes as a surviving immediate family member an individual who will attest via affidavit that, on September 11, 2001, s/he was in a same-sex or opposite-sex domestic partnership with a member of the FDNY who was killed at the WTC site on that date, regardless of where the domestic partners lived on September 11, 2001, or where the surviving domestic partner lives now. This policy is consistent with a post-Windsor policy of treating same-sex marriages on the same terms as opposite-sex marriages to the greatest extent reasonably possible.

2. Application Forms: Completion, Submission, and Records Creation

   Information for WTC Health Program applicants, including application forms, can be found on the How to Apply page. Individuals can also call the WTC Health Program Call Center and request that an application be mailed to them.

   If applicants have questions about how to complete their enrollment application, they can contact the WTC Health Program Call Center. Trained Customer Service Representatives at the WTC Health Program Call Center are able to answer questions regarding the enrollment process. Assistance in languages other than English is available. The CCE outreach teams and the outreach and education contractors (see Chapter 9) also provide enrollment assistance to individuals as part of outreach activities.

   Responder and survivor application forms are sent to the WTC Health Program mailroom (BSOC) at the following address:

   WTC Enrollment
   PO Box 7000
   Rensselaer, NY 12144-7000
   

   Alternatively, applications may be faxed to 1-877-646-5308. BSOC scans the enrollment form and any attachments, and assigns a Document Control Number (DCN), a 12-character length field, in the following format: W (for World Trade Center); 2-digit year; 3-digit Julian date; 4-digit batch number; 3-digit sequential number. The scanned enrollments are delivered to the Enrollment Operations Team via a secure File Transport Protocol (SFTP) server.

   The Enrollment Operations Team, which is part of the HPS Member Services Team (MST), receives the application forms and attachments, assigns them to enrollment processors, and tracks the inventory. The enrollment processor creates the Member Record and the Enrollment Record in the claims processing system.

3. Enrollment Determination

   Applications go through multiple assessment stages. The applications are accepted, entered in the claims processing system, and reviewed by the Enrollment Operations Team. By applying the processes outlined in 42 C.F.R. §§ 88.5 and 88.9, the team determines if more documentation is required to adequately support an application. If more documentation is needed, an enrollment processor reaches out to the applicant immediately to offer guidance. Once adequate documentation is attached to the application, and the application has been entered into the system, the application is sent to the Program’s Member Services Team to make a formal enrollment decision.

   Information on all applicants who are deemed eligible for membership in the Program is then sent to the Federal Bureau of Investigation (FBI) to confirm, per the requirements of the Act, §§ 3311(a)(5) and 3321(a)(4), that they are not on the TWL. Once the applicant is cleared against the TWL, the Enrollment Operations Team is given the direction to officially enroll new members into the Program and the system is updated. The DCs are sent a list of all new enrollees and the NPN is notified of any new NPN enrollees on a weekly basis.

4. Notification to Members

   Notification of membership status is provided to all new members; however, the method by which the members are notified is dependent upon their membership group. Methods have been developed between each member cohort and the Program, as described below.

   1. Responders receive a letter from the WTC Health Program, signed by the Administrator of the WTC Health Program, informing them of their acceptance into the WTC Health Program. They also receive a phone call from an Enrollment Processor to help them understand the network of CCEs that is available to them, and to help them select the CCE that is right for them.
   2. Survivors receive a letter from the WTC Health Program, signed by the Administrator, informing them of their acceptance into the WTC Health Program. This letter details the three hospital locations that treat WTC Health Program survivors in the NY metropolitan area, and provides a centralized booking phone number the members may call to set up their screening appointment.
   3. Responders and survivors who live outside the NY metropolitan area receive a letter signed by the Administrator of the WTC Health Program, informing them of their acceptance into the Program and notifying them that the NPN will be in touch to discuss next steps.
   4. The WTC Health Program may deny Program enrollment if the enrollment criteria are not met; the Program may disenroll a member if the member was mistakenly enrolled or the enrollment was based on incorrect or fraudulent information. Sections 6 and 7 below provides more detail on enrollment and disenrollment, respectively. Denials and disenrollments may be appealed to the Administrator. The Administrator will ensure an appeal review is conducted in a timely manner and notify the applicant of the decision made. Section 8 below provides more detail on the appeal process.

5. Eligibility Criteria

Eligibility criteria are defined by the Act in §§ 3311 and 3321, and found at 42 C.F.R. Part 88.

1. Eligibility for currently identified responders (PHS Act, § 3311(a)(1)(A); 42 C.F.R. § 88.3).
   
   Responders who were identified as eligible for monitoring and treatment under the arrangements in effect on January 2, 2011, between NIOSH and the MMTP) or FDNY were enrolled in the WTC Health Program without being required to submit a new application.
2. Eligibility criteria for WTC responders (PHS Act, § 3311(a)(2); 42 C.F.R. § 88.4).

   Responders to the September 11, 2001, terrorist attacks at the WTC who had not been previously identified as eligible may apply for enrollment in the WTC Health Program, as long as they meet the criteria in one of the following categories:

   1. Firefighters and related personnel:
      1. The individual was an active or retired member of the FDNY (whether firefighter or emergency personnel), and participated at least 1 day in the rescue and recovery effort at any of the former WTC sites (including Ground Zero, the Staten Island Landfill, or the NYC Chief Medical Examiner's Office), during the period beginning on September 11, 2001, and ending on July 31, 2002; or
      2. The individual:
         1. Is a surviving immediate family member of an individual who was an active or retired member of the FDNY (whether firefighter or emergency personnel) who was killed at the Ground Zero on September 11, 2001, and
         2. Received any treatment for a WTC-related mental health condition on or before September 1, 2008.
   2. Law enforcement officers and WTC rescue, recovery, and cleanup workers:
      1. The individual worked or volunteered onsite in rescue, recovery, debris cleanup, or related support services in lower Manhattan (south of Canal Street), the Staten Island Landfill, or the barge loading piers, for at least:
         1. 4 hours during the period beginning on September 11, 2001, and ending on September 14, 2001; or
         2. 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001; or
         3. 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002.
      2. The individual was an active or retired member of the NYC Police Department or an active or retired member of the Port Authority Police of the Port Authority of New York and New Jersey who participated onsite in rescue, recovery, debris cleanup, or related support services, for at least:
         1. 4 hours during the period beginning September 11, 2001, and ending on September 14, 2001, in lower Manhattan (south of Canal Street), including Ground Zero, the Staten Island Landfill, or the barge loading piers; or
         2. 1 day during the period beginning on September 11, 2001, and ending on July 31, 2002, at Ground Zero, the Staten Island Landfill, or the barge loading piers; or
         3. 24 hours during the period beginning on September 11, 2001, and ending on September 30, 2001, in lower Manhattan (south of Canal Street); or
         4. 80 hours during the period beginning on September 11, 2001, and ending on July 31, 2002, in lower Manhattan (south of Canal Street).
   3. Office of the Chief Medical Examiner of NYC employee. The individual was an employee of the Office of the Chief Medical Examiner of NYC involved in the examination and handling of human remains from the WTC attacks, or other morgue worker who performed similar post-September 11 functions for such Office staff, during the period beginning on September 11, 2001, and ending on July 31, 2002.
   4. Port Authority Trans-Hudson Corporation Tunnel worker. The individual was a worker in the Port Authority Trans-Hudson Corporation Tunnel for at least 24 hours during the period beginning on February 1, 2002, and ending on July 1, 2002.
   5. Vehicle-maintenance worker. The individual was a vehicle-maintenance worker who was exposed to debris from the former WTC while retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from the September 11, 2001, terrorist attacks; and conducted such work for at least 1 day during the period beginning on September 11, 2001, and ending on July 31, 2002.
   6. Pentagon responders.
      1. The individual was an active or retired member of a fire or police department (fire or emergency personnel), worked for a recovery or cleanup contractor, or was a volunteer; and
      2. Performed rescue, recovery, demolition, debris cleanup, or other related services at the Pentagon site of the September 11, 2001, terrorist attacks, for at least 1 day beginning September 11, 2001, and ending on November 19, 2001.
   7. Shanksville, PA responders.
      1. The individual was an active or retired member of a fire or police department (fire or emergency personnel), worked for a recovery or cleanup contractor, or was a volunteer; and
      2. Performed rescue, recovery, demolition, debris cleanup, or other related services at the Shanksville, Pennsylvania site of the September 11, 2001, terrorist attacks, for at least 1 day beginning September 11, 2001, and ending on October 3, 2001.
3. Eligibility for currently identified survivors (PHS Act, § 3321(a)(1)(A)(i); 42 C.F.R. § 88.7). Survivors, including WTC responders, who were identified as eligible for medical treatment and monitoring within the WTC EHC Community Program as of January 2, 2011, are considered certified-eligible in the WTC Health Program and are not required to submit a new application.
4. Eligibility criteria for WTC survivors (PHS Act, § 3321(a)(1)(B); 42 C.F.R. § 88.8)
   1. Criteria for status as a screening-eligible survivor. An individual who is not a WTC responder, claims symptoms of a WTC-related health condition, and who has not been previously identified as eligible may apply for a determination of eligibility for an initial health evaluation.
      1. The applicant's eligibility for an initial health evaluation is determined based on one of the following criteria:
         1. The screening applicant was present in the dust or dust cloud in the NYC disaster area on September 11, 2001;
         2. The screening applicant worked, resided, or attended school, childcare, or adult daycare in the NYC disaster area, for at least:
            1. 4 days during the period beginning on September 11, 2001, and ending on January 10, 2002; or
            2. 30 days during the period beginning on September 11, 2001, and ending on July 31, 2002;
         3. The screening applicant worked as a cleanup worker or performed maintenance work in the NYC disaster area during the period beginning on September 11, 2001, and ending on January 10, 2002, and had extensive exposure to WTC dust as a result of such work;
         4. The screening applicant:
            1. Was deemed eligible to receive a grant from the Lower Manhattan Development Corporation Residential Grant Program;
            2. Possessed a lease for a residence or purchased a residence in the NYC disaster area; and
            3. Resided in such residence during the period beginning on September 11, 2001, and ending on May 31, 2003;
         5. The screening applicant is an individual whose place of employment-
            1. At any time during the period beginning on September 11, 2001, and ending on May 31, 2003, was in the NYC disaster area; and
            2. Was deemed eligible to receive a grant from the Lower Manhattan Development Corporation WTC Small Firms Attraction and Retention Act program or other government incentive program designed to revitalize the lower Manhattan economy after the September 11, 2001, terrorist attacks.
   2. Criteria for status as a certified-eligible survivor. Survivors who have been determined to have screening-eligible status may seek status as a certified-eligible survivor. Status as a certified-eligible survivor is based on a certification by the WTC Health Program that, pursuant to an initial health evaluation, the screening-eligible survivor has a WTC-related health condition and is eligible for follow-up monitoring and treatment.

6. Enrollment

1. Acknowledgement. Each application will be acknowledged with an appropriate letter, as follows. Letter templates may be found in the “Eligibility Determinations, Health Condition Certifications, & Treatment Determinations Subject to Member Appeals” policy and procedure document, found in the Program’s file of record.
   1. Acknowledgment of Receipt of Application
   2. Acknowledgement of Receipt + Information Needed
2. Reminder Letters. If additional information is needed to complete an application, the Enrollment Operations Center will make repeated attempts to obtain the information. Letters are sent at 30 and 90 day intervals, as follows. Templates may be found in the “Eligibility Determinations, Health Condition Certifications, & Treatment Determinations Subject to Member Appeals” document:
   1. 30-Day Information Needed Reminder
   2. 90-Day Reminder/Warning Letter
3. Screening. Upon receipt of a completed application, the Enrollment Operations Team prepares summary information for the HPS Member Services Team to review in considering the application. Each eligibility determination gives consideration to:
   1. All information provided by the applicant in the enrollment application;
   2. All other materials that are in the application record held by the Enrollment Operations Team that are related to the requirements for the particular eligibility category or categories for which the applicant may be eligible (for example, supporting documentation which provides proof of presence at the site);
   3. The “WTC Health Program Policy and Procedures for Eligibility Determinations, Health Condition Certifications & Treatment Determinations Subject to Member Appeals” document, as well as any other guidance, protocols, or procedures promulgated by the WTC Health Program; and
   4. Prior enrollment decisions impacting survivors who re-enroll in the WTC Health Program.

   As the Enrollment Operations Team processes applications for final decisions, the Enrollment Operations Team Manager will perform quality assurance by reviewing for accuracy all aspects of the application, including data entry and the decision logic for each recommendation sent to the Program’s Member Services lead. After review of the final application, the Enrollment Operations Team makes one of the following recommendations for dispensation of the application:

   1. Recommend Enroll -- Eligible and qualified for enrollment;
   2. Recommend Deny -- Not eligible and/or qualified for enrollment;
   3. Status Defer -- Survivor otherwise eligible, but applicant does not claim symptoms in application;
   4. Status Inactive -- 180 days after application receipt and request for needed information, information to complete application has not been provided;
   5. Status Closure -- Applicant withdrew application or another reason exists to administratively close file; or
   6. Status Incomplete -- Enrollment Operations Team has requested needed information and is awaiting more information.
4. WTC Health Program’s Determination of Enrollment Eligibility. One of three enrollment determinations will be made for each application:
   1. Enroll;
   2. Deny; or
   3. Suspend determination until more information is available (used in the case of Enrollment Operations Team applicant status of "defer," "inactive," "closure," or incomplete").
5. Enrollment Approval. Prior to final approval of an applicant’s enrollment, the Program transmits the applicant’s information to the FBI to ensure that the applicant is not on the TWL, in compliance with the requirements of the PHS Act and 42 C.F.R. §§ 88.6(c)(3) and 88.10(b)(3).
6. Potential Enrollment Denial. Any enrollment denial recommendation shall be based on a thorough evaluation of the application record by the Enrollment Operations Team before presentation to the WTC Health Program Member Services staff for an enrollment eligibility determination. Applicant enrollment is favored unless clear evidence exists that the applicant does not meet one or more of the eligibility criteria established in the PHS Act and described in 42 C.F.R. §§ 88.4 and 88.8.
7. Notification to Applicant of Enrollment Determination. The Program notifies the applicant of the status of his/her application with the appropriate letter, as follows. Templates may be found in the “Eligibility Determinations, Health Condition Certifications, & Treatment Determinations Subject to Member Appeals” document. The following statuses are possible:
   1. Enroll
      1. Responder Enrollment
      2. Screening-Eligible Survivor Enrollment
   2. Deny

      The notification of a denial of enrollment will be sent whenever contact information is available and will contain the following information:

      1. The reason(s) for denial of enrollment
      2. Details regarding any insufficient documentation to determine the applicant’s eligibility for enrollment:
         1. Insufficient documentation about time, location, activity, or exposure elements;
         2. Insufficient explanation of how the applicant attempted but was unable to obtain the documentation to support time, location, activity, or exposure elements; or
         3. Failure to sign the application attesting that all of the information provided is truthful.
      3. Information about the right to appeal a denial of enrollment and how to file an appeal.
   3. Defer
   4. 180-Day/Inactive
   5. Closure

7. Disenrollment

1. WTC Health Program Disenrollment Decision. The WTC Health Program may disenroll a WTC Health Program member, pursuant to 42 C.F.R. § 88.13, in the following circumstances:
   1. The WTC Health Program mistakenly enrolled an individual who did not provide sufficient proof of eligibility consistent with the required eligibility criteria; or
   2. The WTC Health Program member’s enrollment was based on incorrect or fraudulent information.
2. Notification to Disenrolled Member. A disenrolled WTC Health Program member will be notified in writing by the WTC Health Program of a disenrollment decision, provided an explanation, as appropriate, for the decision, any administrative actions resulting from the decision, and provided information on how to appeal the decision. A disenrolled WTC Health Program member may appeal the disenrollment decision in accordance with Section 8 below.

8. Appeal of Enrollment Denial

All applicants have the right to appeal an enrollment denial or disenrollment decision, pursuant to 42 C.F.R. § 88.14. In accordance with the regulations, the Administrator will appoint a Federal Official to review the appeal request. The Federal Official is independent of the WTC Health Program and not engaged in any enrollment and eligibility or disenrollment decisions other than appeals, allowing for an objective third-party review of the facts. The appeal procedure is as follows:

1. The applicant's appeal request must be submitted to the WTC Health Program within 120 calendar days of the date of the notification letter. The appeal request can be mailed or submitted electronically to the appeal coordinator at:

   Appeal Coordinator
   WTC Health Program
   P.O. Box 7000
   Rensselaer, NY 12144
   Fax: 1.404.471.8338

2. The request for appeal must identify the applicant or disenrolled member and designated representative, if applicable, and state the reason(s) why the individual believes the denial was incorrect. The request may include relevant new evidence not previously considered by the WTC Health Program.
3. The WTC Health Program Appeal Coordinator reviews the appeal of enrollment denial or disenrollment and, in a timely manner, determines if the appeal is valid. Valid appeals are referred to the appointed Federal Official for review and recommendation.
4. The Federal Official will review all available records and assess whether the appeal should be granted. The Federal Official may consider additional relevant new information submitted and will provide a recommendation regarding the disposition of the appeal to the Administrator.
5. After receipt of the Federal Official’s recommendation, the Administrator will make a final decision on the appeal.
6. The applicant is notified of the appeal outcome, as well as any actions taken by the WTC Health Program resulting from the decision, with the appropriate letter from the Administrator of the WTC Health Program. Templates of these letters may be found in the “Eligibility Determinations, Health Condition Certifications, & Treatment Determinations Subject to Member Appeals” document:
   1. Appeal of Enrollment Denial Granted -- Notice that appeal of enrollment eligibility denial was granted
   2. Appeal of Enrollment Denial Denied -- Notice that appeal of enrollment denial was denied
   3. Appeal Received -- Appeal is referred to the appropriate Federal agency

Appendices

Appendix 2-A FDNY Responder Eligibility Application
Appendix 2-B Responder Eligibility Application (Other Than FDNY)
Appendix 2-C Survivor Eligibility Application
Appendix 2-D Pentagon/ Shanksville Eligibility Application

Chapter 3- Certification of Health Conditions

1. Purpose and Scope

The purpose of this chapter is to describe the circumstances in which a health condition may be certified under Title XXXIII of the PHS Act, the certification process, responsibilities in the certification process, conditions that may be certified, communications regarding certifications, and appeals of certification decisions. Further detail on the certification process is provided in the WTC Health Program Member Services Operations Manual, found in the Program’s file of record.

2. Statutory and Regulatory References

The following sections of Title XXXIII of the PHS Act are applicable to this Chapter:

1. Section 3312(a)(1)(A) defines a WTC-related health condition as:
   1. “[A]n illness or health condition for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition…;” or
   2. “[A] mental health condition for which such attacks, based on an examination by a medical professional with experience in treating or diagnosing the health conditions included in the applicable list of WTC-related health conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition….”
2. Section 3312(b)(1) states that if a physician at a Clinical Center of Excellence (CCE) makes a determination that a WTC responder has a WTC-related health condition included in the List of WTC-Related Health Conditions (List) and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the condition, then the physician is to transmit that determination and the medical facts supporting the determination to the WTC Health Program. After review of the CCE physician’s determination, the WTC Health Program will certify the health condition if he finds that it is on the List of WTC-Related Health Conditions and that exposure to airborne toxins, other hazards, or adverse conditions resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the health condition. The WTC Health Program will pay for medically necessary treatment of certified WTC-related health conditions (see § 3312(c)(1)). In addition, the Administrator must establish a process to appeal certification decisions.
3. Section 3312(b)(5) authorizes treatment pending certification for responders, and section 3322(a) extends the same benefits to survivors.
4. Section 3321(a)(2)(B) requires the Administrator of the WTC Health Program to establish a certification process for screening-eligible WTC survivors who are eligible for further monitoring and treatment after their initial screening exam.

The following provisions in the WTC Health Program regulations in 42 C.F.R. Part 88 are also applicable to this Chapter:

• Section 88.1 includes definitions of the following relevant terms: Aggravating, Certification; Health condition medically associated with a WTC-related health condition; List of WTC-Related Health Conditions; Medically necessary treatment; WTC-related acute traumatic injury; WTC-related health condition; and WTC-related musculoskeletal disorder.
• Section 88.15, List of WTC-Related Health Conditions.
• Section 88.16, Addition of health conditions to the List of WTC-Related Health Conditions.
• Section 88.17, Physician’s determination of WTC-related health conditions.
• Section 88.18, Certification.
• Section 88.19, Decertification.
• Section 88.20, Authorization of treatment.
• Section 88.21, Appeal of certification, decertification, or treatment authorization decision.
• Section 88.25, Reopening of WTC Health Program final decisions.

3. Responsibilities

The parties involved in certifying health conditions and their responsibilities are detailed below.

1. The Clinical Centers of Excellence/Nationwide Provider Network (CCEs)/(NPN) provide monitoring and screening examinations for eligible responders and survivors. The CCE/NPN ensures that requests for certification of a member’s health condition are completed using the appropriate forms and procedures. The CCE/NPN transmits the completed health condition certification request in a secure manner to the Program’s Health Program Support (HPS) contractor for processing (see Section 6, below for more information regarding secure data transfer). The WTC Health Program’s certification decision is sent to the member and CCE/NPN via letter. Upon receipt of a decision by the Program to certify a health condition, the CCE/NPN is authorized to provide medically necessary treatment to the member for that condition and shall be responsible for providing adequate treatment services or referrals, which will be scheduled by the CCE/NPN.
2. The Program’s Medical Benefit Manager (MBM) has been designated by the Administrator to determine whether a health condition meets the requirements for certification. The MBM reviews an official request by the CCE/NPN to certify a member’s health condition for treatment to be covered by the Program and leads the Certification Team that conducts this function. The MBM consults with the Administrator regarding certifications as necessary.
3. The Program’s HPS contractor is responsible for receiving and processing certification requests from the CCE/NPN for the Program’s Certification Team to evaluate. The HPS contractor also receives the Program’s decisions, updates the system of records, and supports the communication process with the CCE/NPN and member.

4. Covered Conditions

1. The following WTC-related health conditions covered by the WTC Health Program are established in 42 C.F.R. § 88.15:
   1. Aerodigestive disorders:
      1. Interstitial lung diseases;
      2. Chronic respiratory disorders – fumes/vapors;
      3. Asthma;
      4. Reactive airways dysfunction syndrome (RADS);
      5. WTC-exacerbated or new-onset chronic obstructive pulmonary disease (COPD);
      6. Chronic cough syndrome;
      7. Upper airway hyperreactivity;
      8. Chronic rhinosinusitis;
      9. Chronic nasopharyngitis;
      10. Chronic laryngitis;
      11. Gastroesophageal reflux disorder (GERD);
      12. Sleep apnea exacerbated by or related to a condition described in i-xii.
   2. Mental Health Conditions:
      1. Posttraumatic stress disorder (PTSD);
      2. Major depressive disorder;
      3. Panic disorder;
      4. Generalized anxiety disorder;
      5. Anxiety disorder (not otherwise specified);
      6. Depression (not otherwise specified);
      7. Acute stress disorder;
      8. Dysthymic disorder;
      9. Adjustment disorder;
      10. Substance abuse.
   3. Musculoskeletal Disorders (only for WTC responders to the New York City disaster area):
      1. Low back pain;
      2. Carpal tunnel syndrome (CTS);
      3. Other musculoskeletal disorders.
   4. Cancers:
      1. Malignant neoplasms of the lip, tongue, salivary gland, floor of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and other oral cavity and pharynx.
      2. Malignant neoplasm of the nasopharynx.
      3. Malignant neoplasms of the nose, nasal cavity, middle ear, and accessory sinuses.
      4. Malignant neoplasm of the larynx.
      5. Malignant neoplasm of the esophagus.
      6. Malignant neoplasm of the stomach.
      7. Malignant neoplasm of the colon and rectum.
      8. Malignant neoplasm of the liver and intrahepatic bile duct.
      9. Malignant neoplasms of the retroperitoneum and peritoneum, omentum, and mesentery.
      10. Malignant neoplasms of the trachea; bronchus and lung; heart, mediastinum and pleura; and other ill-defined sites in the respiratory system and intrathoracic organs.
      11. Mesothelioma.
      12. Malignant neoplasms of the peripheral nerves and autonomic nervous system, and other connective and soft tissue.
      13. Malignant neoplasms of the skin (melanoma and non-melanoma), including scrotal cancer.
      14. Malignant neoplasm of the female breast.
      15. Malignant neoplasm of the ovary.
      16. Malignant neoplasm of the prostate.
      17. Malignant neoplasm of the urinary bladder.
      18. Malignant neoplasm of the kidney.
      19. Malignant neoplasms of the renal pelvis, ureter and other urinary organs.
      20. Malignant neoplasms of the eye and orbit.
      21. Malignant neoplasm of the thyroid.
      22. Malignant neoplasms of the blood and lymphoid tissues (including, but not limited to, lymphoma, leukemia, and myeloma).
      23. Childhood cancers: Any type of cancer diagnosed in a person less than 20 years of age.
      24. Rare cancers: any type of cancer that occurs in less than 15 cases per 100,000 persons per year in the United States (based on 2005–2009 average annual data age-adjusted to the 2000 U.S. population).
   5. Acute Traumatic injuries:
      1. Eye injury.
      2. Burn.
      3. Head trauma.
      4. Fracture.
      5. Tendon tear.
      6. Complex sprain.
      7. Other similar acute traumatic injuries.
2. Special Note on Malignancy for Cancers
   1. Solid Neoplasms
      1. To qualify as a malignant neoplasm, a solid neoplasm must:
         1. Have been diagnosed after September 11,2001 and meet the WTC Health Program’s minimum latency criteria for the specific cancer (see Minimum Latency & Types or Categories of Cancer); and
         2. Be characterized histopathologically as malignant and “invasive,” i.e., having evidence of growth or spread beyond the layer of tissue in which it first developed or in which it was first diagnosed.
      2. To qualify as a malignant neoplasm, non-invasive neoplasms including carcinomas in situ must:
         1. Have been diagnosed after September 11,2001 and meet the WTC Health Program’s minimum latency criteria for the specific cancer.
         2. Be characterized histologically as malignant and be regarded in the peer-reviewed scientific literature as having an increased risk of developing into an invasive neoplasm. Non-invasive neoplasms, including carcinomas in situ, will be evaluated on a case-by-case basis. The review will include consideration of the treatment recommendations made by the National Comprehensive Cancer Network (NCCN). Such reviews will be documented and included in the member file where relevant to a specific cancer certification evaluation.
      3. Non-invasive neoplasms ineligible for certification:
         1. A non-invasive neoplasm that is completely removed surgically during an excisional biopsy or resection of an organ or body part containing the lesion may be curative (i.e., NCCN Guidelines recommend no further treatment). The following carcinomas in situ have been determined to be examples of such types of non-invasive neoplasms and are, therefore, ineligible for certification:
            • Breast: Lobular cancer in-situ (CIS) [except pleomorphic lobular CIS]
            • Colon and rectum: CIS [including high grade intraepithelial and intramucosal neoplasia]
            • Gallbladder: CIS
         2. Non-invasive neoplasms of the cervix uteri are ineligible for certification. The following lesions have been determined to be examples of such types of non-invasive neoplasms and are, therefore, ineligible for certification:
            • Cervical intraepithelial neoplasia (CIN): CIN grade I, CIN grade II, and CIN grade III
            • Carcinoma in situ of the cervix uteri
      4. Histologically benign neoplasms are ineligible for certification.
   2. Liquid neoplasms

      To qualify as a malignant neoplasm, a liquid neoplasm must:

      1. Have been diagnosed after September 11,2001 and meet the WTC Health Program’s minimum latency criteria for the specific cancer (see Minimum Latency & Types or Categories of Cancer); and
      2. Exhibit uncontrolled clonal growth of a specific type of hematopoietic cell.
      
      
   3. Cancers of Unknown Primary Origin (CUPs)

      These are histologically-proven, metastatic, malignant neoplasms the primary origin of which cannot be identified during pre-treatment evaluation. The date of diagnosis of the metastatic disease will be used to evaluate eligibility (minimum latency criteria) for certification of CUPs.

   4. Metastasis or recurrence of a pre-existing malignant neoplasm

      For malignant neoplasms diagnosed before September 11, 2001, and those diagnosed after September 11, 2001 but with insufficient latency, any recurrence or metastasis from such malignant neoplasms will not be considered for certification regardless of the amount of time that passes between remission of the pre-existing neoplasm and its recurrence or metastatic spread. An exhaustive search of the scientific literature has failed to identify evidence that toxic exposures aggravate, cause, or contribute to a pre-existing cancer resulting in a recurrence or metastasis that requires a change in treatment.

   5. Second primary cancers

      A second primary cancer is a histologically-proven, new primary malignant neoplasm developing in a person with a history of cancer. The term applies to malignant neoplasms that have arisen independently and not as a result of recurrence or metastasis of the original primary malignant neoplasm. A second primary cancer is considered eligible for certification if it was diagnosed after September 11, 2001 and meets the WTC Health Program’s minimum latency criteria for the specific cancer. Alleged cases of second primary cancers originating from the same tissue and/or of the same histological type as a malignant neoplasm that is certified, certifiable, or ineligible for certification will be evaluated on a case-by-case basis. The review will include consideration of the peer-reviewed scientific literature and Surveillance, Epidemiology, and End Results (SEER) Program Multiple Primary and Histology Coding Rules. Such reviews will be documented and included in the member file where relevant to a specific cancer certification evaluation.

3. Health Conditions Medically Associated with WTC-Related Health Conditions

   A condition that is medically associated with a WTC-related health condition is also eligible for certification and treatment within the WTC Health Program. In order for a medically associated health condition to be certified, the condition must result from the treatment or progression of a WTC-related health condition. The underlying WTC-related health condition must first be certified by the WTC Health Program before any conditions may be certified as medically associated with the underlying condition. Medically associated conditions are evaluated and certified on a case-by-case basis.

   The WTC Health Program requires that the CCE or NPN physician provide a detailed explanation in the WTC-3 Certification Request form (Appendix 3-A), and medical records as appropriate, that the health condition under consideration as medically associated resulted from either treatment or progression of the underlying certified WTC-related health condition. See Health Conditions Medically Associated with World Trade Center-Related Health Conditions.

   1. Establishing that the Medically Associated Health Condition “Results from” Treatment of a Certified WTC-Related Health Condition

      The WTC Health Program will review the CCE or NPN’s explanation to determine if: (i) the relationship linking the medically associated health condition the WTC-related health condition occurs without the influence of an intermediary health condition or event; and (ii) the linkage between the certified WTC-related health condition and the medically associated health condition resulting from treatment of the certified WTC-related health condition has been well-established by published peer-reviewed scientific literature.

      1. “Results from” Treatment. The CCE or NPN physician must demonstrate by means of a detailed narrative (including medical records when appropriate) that the health condition “results from” medical treatment of the underlying certified WTC-related health condition without the influence of an intermediary health condition or event. The WTC Health Program will certify as medically associated only those conditions which directly result from treatment of a WTC-related health condition, i.e., that the medically associated condition occurred in absence of intervening medical events.

         Note: CCE and NPN physicians are encouraged to consult with the Director, WTC Health Program Medical Benefits, about medically associated health conditions that result from treatment of a certified WTC-related health condition as certification will depend on the particular medical facts of each case.

      2. Previously Published in Peer-Reviewed Literature. The CCE or NPN physician must demonstrate that the medical association between the underlying [certified WTC-related] health condition and the medically associated health condition resulting from treatment of the underlying [certified WTC-related] health condition has been established in previously published peer-reviewed medical literature. The establishment of this medical association in the literature must be documented in the member file, whether included as part of the physician’s narrative or otherwise captured by Program staff.
      
      
   2. Establishing that the Medically Associated Health Condition “Results from” Progression of a Certified WTC-Related Health Condition

      The WTC Health Program will review the CCE or NPN physician’s explanation to determine if: (i) the relationship linking the medically associated condition with the WTC-related health condition occurs without the influence of an intermediary health condition or event; and (ii) the linkage between the certified WTC-related health condition and the medically associated condition resulting from progression of the certified WTC-related health condition has been well-established in published, peer-reviewed scientific literature.

      1. “Result from” Progression. The CCE or NPN physician must demonstrate by means of a detailed narrative (including medical records when appropriate) that the health condition ”results from” progression of the underlying certified WTC-related health condition without the influence of an intermediary health condition or event.

         Note: CCE and NPN physicians are encouraged to consult with the Director, WTC Health Program Medical Benefits, about medically associated health conditions that are the result of progression of a certified WTC-related health condition as certification will depend on the particular medical facts of each case.

      2. Previously Published in Peer-Reviewed Literature. The CCE or NPN physician must demonstrate that the medical association between the underlying [certified WTC-related] health condition and the medically associated health condition resulting from progression of the underlying [certified WTC-related] health condition has been established in previously published peer-reviewed medical literature. The establishment of this medical association in the literature must be documented in the member file, whether included as part of the physician’s narrative or otherwise captured by Program staff.

5. CCE/NPN Physician Determination and Request for Certification of Health Conditions

When a member is diagnosed with a health condition that the provider believes is related to a 9/11 exposure, the member may be eligible for medical treatment for that condition under the Program.

1. CCE/NPN Physician Determination

   If, following an initial health evaluation or monitoring or treatment exam, the treating CCE or NPN physician determines that the member has a health condition which is a qualifying condition covered by the Program, as described in Section 4, and that member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition or mental health condition, then the physician must submit this determination to the Program and request certification of the health condition in order to provide treatment under the Program.

2. Secondary Review of Negative Physician Determination

   Where a member’s CCE/NPN makes a negative determination (a finding that exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is not substantially likely to be a significant factor in aggravating, contributing to, or causing the health condition or mental health condition) and declines to request certification of the health condition by the WTC Health Program, the member may request a secondary review of this decision by writing the Clinical Director of the CCE or NPN. The procedure for a secondary review is as follows:

   1. The member is informed by the CCE/NPN of the decision to not request certification in a timely manner, and is informed of his/her right to obtain secondary review; this should occur ideally through a Clinic visit.
   2. If the member disagrees with the decision to not request certification, s/he shall be given counsel regarding the secondary review process and provided a brochure detailing his/her rights in terms of obtaining a secondary review. To initiate the secondary review process, the member must send a letter to the CCE/NPN Clinical Director, or designee, which clearly indicates his/her request to obtain secondary medical review.
   3. The CCE/NPN Clinical Director or designee then performs a review of the case. This designee can be a CCE physician at another CCE.
   4. If the secondary review upholds the original decision to not request certification, then the CCE /NPN Clinical Director must send a written letter to the member (within 4 weeks) which summarizes the decision and provides an explanation of how this decision was made. A copy of this letter should be sent to the Administrator of the WTC Health Program.
   5. If the secondary review finds that WTC-relatedness is supported, the CCE/NPN Clinical Director must send a written letter to the member informing him/her of this decision. This letter should state that a WTC-3 request for certification will now be sent to the WTC Health Program, with an attestation coming from the physician who performed the secondary review.
   6. The CCE/NPN shall track all secondary review decisions and may make recommendations to the Administrator of the WTC Health Program, as appropriate, when such decisions point to a need for an evaluation or change to Program policies and procedures.
      
      
3. CCE/NPN Requests certification from the Program Using the WTC-3 Form

   The WTC-3 Certification Package is the standard documentation completed by a CCE/NPN physician to request certification for a member’s health condition; it provides the medical rationale linking the exposure to the stated health condition. A sample of the form is provided in Appendix 3-A. This form must be used for any condition which a physician has determined to be WTC-related since the Program CCE contracts were implemented [i.e., as of July 1, 2011 for enrolled responders; as of September 29, 2011 for enrolled survivors; and as of October, 2013 for enrolled members assigned to the Nationwide Provider Network (NPN)]. The Clinical Director of the CCE or the NPN reviews, approves and securely submits the completed WTC-3 Certification Package signed by the examining or responsible physician to the Program. Such forms are also used to request certification of health conditions as medically associated with a WTC-related health condition.

   The WTC-3 Certification Package contains identifying information for the member and examiner, diagnostic codes for the condition(s) for which the member is requesting certification, and either a medical rationale linking 9/11 exposure to the health condition or the medical rationale linking the medically associated health condition to an existing WTC-related health condition. For a health condition medically associated with a WTC-related health condition, the physician’s determination shall contain information on how the health condition has resulted from treatment of a previously certified WTC-related health condition, or how it has resulted from progression of the certified WTC-related health condition. All cancer certification requests require a pathology report to be submitted with the WTC-3 Certification Package. Specific guidance regarding how to complete the WTC-3 Certification Package, including reasonable practice examples using Program-approved templates, is provided below.

   When providing a rationale for the certification, requesters use an explanatory narrative that may be combined with Program-approved template within the WTC-3 form. The rationale should contain pertinent information about 9/11 exposure and time-linked emergence of symptoms. Facts available from the standardized monitoring or screening examination, including exposure assessment, presenting symptoms and temporal relationship of these symptoms relative to 9/11 exposure, should be included. Medical findings should be documented in the institutional medical record, which include the screening or monitoring exams and any additional medical testing or imaging studies required to establish the diagnosis. By procedure, the member’s institutional medical record is incorporated by reference when the CCE provider or NPN Medical Director requests certification using the WTC-3 Certification Package. This process provides the Program with all relevant information required to make an informed decision regarding the member’s certification. See Appendix 3-B for instructions specific to completing the WTC-3 form for cancer.

   The WTC-3 submission must include a signed affirmative statement by the physician that the member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition or mental health condition. If the physician is unable to make such and affirmative finding, then the WTC-3 cannot be submitted or considered.

4. Previous Program Members Certified Using WTC-2 Batch Process

   The WTC-2 batch certification process was used for a subset of program members who had treatment initiated for qualifying conditions as part of the previous federally-sponsored programs (the Medical Monitoring and Treatment Program (MMTP) for responders and/or the Environmental Health Clinic (EHC) for community members). This process was implemented to ensure treatment continuity for members already receiving care under predecessor programs and is no longer being used.

   If the certifications for qualified conditions were supported by documentation in the members’ medical records, the Clinical Director of the CCE or the NPN submitted an attestation for all members and their associated conditions via electronic spreadsheet. The spreadsheet contained identifying member information and diagnostic codes for each qualifying WTC-related or medically associated condition that required certification. The CCE/NPN then transmitted the WTC-2 batch certification request to the Program in a secure manner (as described in Section 6, below). The Program verified the requested conditions against the Codebook (described further in Section 9, below) and returned any discrepant data to the submitter for rectification. Periodic summary reports of certified conditions by member were then sent to the CCE/NPN by the HPS contractor.

   The CCE/NPN is responsible for maintaining a record of a member’s certifications to enable appropriate service authorization decisions. As part of their Quality Assurance Program the CCE/NPN conducts internal audits of their contracted part of the WTC Health Program at a minimum of every quarter. These data are made available to the Administrator of the WTC Health Program or designee. Where data is obtained, through a quality assurance audit or otherwise, that indicates that the certification issued through the WTC-2 process was incorrect, the Administrator of the WTC Health Program may de-certify a condition as appropriate.

6. Overview of the Certification Process

Certification is the lynchpin by which the Program ensures members receive appropriate services and that all services are provided in accordance with statutory and regulatory requirements. A CCE/NPN is responsible for submitting requests for health condition certification using the WTC-3 form. The WTC Health Program then reviews and evaluates the request (WTC-3) and makes one of three possible decisions for each health condition contained within the request:

1. The health condition is certified, enabling the member to receive treatment for the certified health condition;
2. The health condition is denied certification, which gives the member the right to request an appeal of the denial decision; or
3. The request is suspended and categorized by the WTC Health Program as a “re-do” pending receipt of additional information about the request from the CCE or NPN physician submitting the request.

1. The certification process begins when the CCE/NPN examines the member and makes a determination regarding whether the member has an illness which is covered in the WTC Health Program and that the member’s 9/11 exposure is related to his or her illness.
2. The CCE/NPN completes and submits the WTC-3 package (including supporting documents) to the Program in one of three ways:
   1. By mail to the WTC Health Program mailroom;
   2. By fax to the secure WTC Health Program fax number; or
   3. By placing a PDF version of the WTC-3 package on the Program’s secure file transfer protocol (SFTP) server.
3. For paper and fax submissions, the mailroom scans the package, assigns a document control number (DCN), uploads the scanned document to the SFTP server for the HPS Member Services Team (MST) to access, and notifies the MST that certification requests are available for review. In this way, the MST accesses all submitted packages from one consolidated location – the SFTP server.
4. The MST reviews the submitted WTC-3 package to determine whether it is complete and can be processed. A WTC-3 package is considered to be complete if:
   1. The WTC-3 form is legible and fully filled out;
   2. A supporting narrative/assessment is provided;
   3. The WTC-3 form is signed and dated by the member’s health provider and includes the required physician determination and attestation that the member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition or mental health condition; and
   4. The member for whom certification is being requested is enrolled as a member in the Program.
5. If the CCE/NPN request for certification is found to be incomplete, the request will be categorized as a “re-do” (neither certified nor denied), and held in a suspended status until specific facts are either supplied (when missing) or clarified (when too vague or misleading) by the CCE or NPN submitting the request for certification. As a result of the request for certification being suspended, the member is not eligible to receive medical or pharmacy benefits for the health condition subject to request for certification (see section below regarding the request for a time-limited authorization of treatment pending certification). If a certification is made via a follow up submission, the effective date of the certification will always be assigned as the signature date of the original submission.
6. If the MST determines that the WTC-3 package is complete and the member is properly enrolled, the package is forwarded to the NIOSH MBM for review and approval. Certifications are forwarded to the MBM on a weekly basis.
7. The NIOSH MBM reviews the certification requests and makes determinations to approve or deny the certification or to request a “redo,” when necessary (e.g., due to missing information). The MBM also determines the effective date for medical benefits, and notifies the MST of the decisions.
8. Upon approval by the MBM, the MST updates the claims processing system, assigns benefit plans as appropriate, and notifies the CCE/NPN of the decisions.

7. Authorization of Treatment Pending Certification

Authorization of Treatment Pending Certification is permitted pursuant to Sections 3312(b)(5) (responders) and 3322(a) (survivors) of the PHS Act and 42 C.F.R. § 88.20(c). Treatment pending certification is offered, where specifically requested by a CCE/NPN physician, in order to provide timely institution of therapy or continuity of care while a certification request is being reviewed.

1. In the past, the WTC-1 Form was used to request this authorization as a means of providing “continuity of care” for the subgroup of members receiving treatment in the previous federally sponsored programs (MMTP and EHC) until the new certification process was implemented. This process expired in November 2011, and the form was retired.
2. The WTC-3 Certification Process. Under the current certification process, while certification is pending, authorization for time-limited treatment of a WTC-related health condition or a health condition medically associated with a WTC-related health condition may be requested at the CCE/NPN physician’s discretion through the WTC-3 Form. Such authorization must be obtained from the WTC Health Program before treatment is provided, except for the provision of treatment for a medical emergency. Treatment rendered after WTC-3 submission but prior to certification will only be covered if the request for treatment pending certification was included in the WTC-3 submittal, the care delivered does not require Level 2 or 3 Prior Authorization, the request for certification is ultimately granted, and the treatment provided is medically necessary, follows Program guidelines, and is rendered by a CCE/NPN-affiliated provider. In the event that the condition is denied certification, any care provided for the condition that is outside the parameters of the Diagnostic Plan will not be covered and the CCE or NPN providing the care will be responsible for the costs of such care.
3. If the certification request is determined to be unsatisfactory, then the authorization for treatment pending certification is discontinued immediately and related claims are pended for up to three weeks, during which time the CCE or NPN will work with the MST to rectify any deficiencies in the request, if possible. After 3 weeks, unsatisfactory certification requests will convert to a denial of certification and appropriate Program actions (see Sections 8 and 10, below).

8. Certification Decisions

1. Potential Outcomes Following a Request for Certification

   A CCE or NPN physician is responsible for submitting requests for certification of a health condition using the WTC-3 form. The WTC Health Program then reviews and evaluates the request (WTC-3) and makes one of the three following decisions for each health condition contained within the request:

   1. The member’s health condition is certified, enabling the member to receive treatment for the certified health condition;
   2. The member’s health condition is denied certification, which gives the member the right to request an appeal of the denial decision; or
   3. The request for certification is “suspended” pending receipt of additional or clarifying information regarding the certification request submitted by the CCE or NPN.
2. Communicating Certification Request Outcomes to Members

   The Program makes every effort to make informed decisions regarding WTC-related health condition certifications in a timely manner and to communicate those decisions to the member efficiently. For certification requests of health conditions medically associated with a WTC-related health condition, the Program will render a decision and notify the member in writing of the decision and the reason for the decision within 60 calendar days after the date the physician’s determination was received. To that end, the Program has developed decision letters addressing the range of decisions that could be made in the certification process (e.g., approval or denial of certification request, the need for additional information to inform the certification decision, etc.). When a member’s health condition is approved for certification as either a WTC-related health condition or a medically associated health condition, the Program sends the member a letter informing him/her of the certification and provides electronic notification to the CCE/NPN that requested the certification. When a member’s requested health condition is denied certification, the Program sends the member letter informing him/her of the denial and provides an electronic copy of the letter to the requesting CCE/NPN. The denial letter discusses the condition requested, the reason for the denial, and the information submitted to the Program for review from the CCE or NPN. The letter also answers frequently asked questions and provides instructions about how appeal the denial decision.

3. Suspended Requests for Certification

   A suspended request for certification is neither certified nor denied, but has been placed in an administratively pended status until specific facts are either supplied (when missing) or clarified (when too vague or misleading) by the CCE or NPN submitting the request for certification.

   1. Time to Provide Information to Resolve a Suspended Request for Certification

      The WTC Health Program will notify the CCE or NPN that submitted the request for certification when more information is required to complete processing of the request for certification. This notification will be made in writing by electronic message (via secure portal). The CCE or NPN has 60 days from the date of the written notification from the WTC Health Program to provide the Program with the requested additional information. The WTC Health Program will provide weekly updates to each CCE or NPN regarding any outstanding requests for certification that have been suspended pending additional information and the number of days that have elapsed since the notification and request for additional information for each case was sent to the CCE or NPN.

   2. Effect of Suspended Request for Certification on Authorization of Treatment Pending Certification

      As a result of the request for certification being suspended, the WTC Health Program member is generally not eligible to receive medical or pharmacy benefits for the health condition subject to request for certification. However, if the original submission requesting certification of a given condition included a time-limited authorization of treatment pending certification, the requesting CCE or NPN may choose to continue providing benefits to the member at their own expense. In the event that the suspended request for certification is subsequently approved through timely rectification of the record, reimbursement of treatment services will be permitted with an effective date of the signature date of the original WTC-3 submission. In the event that the condition is denied certification, any care provided outside the parameters of the Diagnostic Plan will not be covered and the CCE or NPN providing the care will be responsible for the costs of such care. If the concerns resulting in the suspended request are not resolved after 60 days as outlined above, then any authorization for treatment pending certification is terminated and the member is notified as per protocol.

   3. Resolution of a Suspended Request for Certification

      There are five potential outcomes for a request for certification that has been placed in a suspended status; those outcomes are as follows:

      1. Certification After Receipt of Additional Information from the CCE or NPN

         The CCE or NPN responds to the notification of a suspended request for certification with additional or clarifying information. Based on this information, the Program is able to certify the health condition.

      2. Denial of Certification After Receipt of Additional Information from the CCE or NPN

         The CCE or NPN responds to the notification of a suspended request for certification with additional or clarifying information. This additional information does not satisfy the requirements for certification, however, and results in a denial of certification for the health condition. The member has the right to appeal the denial decision.

      3. Administrative Closure Following a Request by the CCE or NPN to Withdraw the Certification Request

         The CCE or NPN responds to the notification of a suspended request for certification by indicating in writing that they would like to withdraw the original request for certification. If a withdrawal is requested, the WTC Health Program will no longer evaluate the request for certification and will administratively close the request file. Reasons for withdrawal may include the CCE/NPN determining that the requested information cannot be supplied in a timely manner or newly recognizing that the request for certification cannot be supported based on established WTC Health Program criteria. The CCE/NPN will inform the member of the withdrawal of the request for certification, and advise the member of their right to a secondary review.

      4. Denial of Certification Following an Insufficient Response from the CCE or NPN After Request for Additional Information

         If the CCE or NPN responds to the WTC Health Program’s notification of suspended request for certification but is unable to provide the requested information necessary to resolve the suspended certification request within the 60 day time limit allowed for final resolution of the request, then the WTC Health Program will take the following actions. The WTC Health Program will send a written communication to the CCE/NPN (via electronic message) asking for confirmation that they cannot provide additional information but that they still wish to request certification for the health condition. If the CCE/NPN responds in writing (via electronic message) that this is the case, then the WTC Health Program will deny the request for certification of the health condition due to lack of sufficient information to make a definitive evaluation of the link between 9/11 exposure and the requested health condition or between the WTC-related health condition and the requested medically associated health condition. The WTC Health Program will inform the member of the denial and his or her right to request an appeal of the denial decision.

      5. Administrative Closure Following No Response from the CCE or NPN After Request for Additional Information

         If the CCE or NPN does not respond at all to the notification of a suspended request for certification within the 60 day time limit allowed for final resolution of the request, then the WTC Health Program will administratively close the request for certification of the health condition due to lack of sufficient information to support a physician’s determination (upon which a certification decision could be based). Similarly, if the WTC Health Program asks the CCE/NPN for a confirmation that they cannot provide additional information but that they still wish to request certification for the health condition (as outlined above) and the response from the CCE/NPN is unclear or equivocal as to the intent to request certification, then the WTC Health Program will administratively close the request for certification of the health condition due to lack of sufficient information to support the physician’s determination. In either case, the WTC Health Program will notify the CCE or NPN in writing via electronic message that the request for certification has been administratively closed. The CCE/NPN will inform the member of the administrative closure of the request for certification, and advise the member of his or her right to a secondary review. The CCE/NPN may submit a new WTC-3 at a later date should additional or clarifying information becomes available.

9. Linking Member Health Benefits to Certified Health Conditions

WTC-related health conditions identified in 42 C.F.R. § 88.15 have been grouped into certification categories to align the limited coverage intent of the Program with standards of care and principles of medical necessity. The WTC Health Program defined the business rules used in the processing (adjudication) of healthcare claims to ensure compliance with the limited coverage intent of the Program. Each member category – General Responder, Screening-eligible Survivor, Certified-eligible Survivor, FDNY Responder, and FDNY Family Member – is associated with one or more designated benefit plans. The WTC Health Program Codebook contains the covered diagnosis codes (ICD-9, or if after October 1, 2015, ICD-10), procedural codes (CPT-4 and HCPCS), and pharmaceutical codes (Rx) for the Program. Providers are responsible for working with the CCE/NPN to determine allowable services. A more complete description of these categories and benefit plans may be found in Chapter 4.

1. The Program Codebook describes the diagnoses and services covered under the Program and consists of accepted medical coding for the following:
   1. Health condition diagnoses – defined by the current World Health Organization’s (WHO’s) International Classification of Disease, 10th edition and Clinical Modification (ICD10-CM) and the World Health Organization’s International Classification of Diseases for Oncology, 3rd edition (ICD-O-3);
   2. Health services – defined as procedures by the American Medical Association’s Current Procedural Terminology (CPT®);
   3. Provider-administered pharmaceutical products or durable medical equipment (DME) by the Centers for Medicare & Medicaid Services’ (CMS’s) Healthcare Common Procedural Coding System (HCPCS); and
   4. WTC Health Program Formulary – medications by therapeutic class, brand name, and generic name.
2. Medical coding is regularly updated as per source coding references (ICD, CPT, and HCPCS) and as per requirements published by HHS (e.g., transition to WHO’s International Classification of Diseases, 10th edition [ICD-10] on October 1, 2015). The Codebook is updated through a systems change management process (see Chapter 4), and version control is maintained through regular electronic dissemination and posting on a centralized Program website. The official version of the Codebook is found in the Program’s file of record.
3. Care Suites have been developed by the Program to link the adjudication of healthcare claims with a member’s health benefits, including the care required to manage certified health condition(s). Care Suites are defined by the medical coding that comprises both the allowable conditions within a certification category, and the medical care required to manage these conditions via allowable procedures and products. The Care Suites guide the processing of healthcare claims. Further discussion of Care Suites can be found in Chapter 4, and a full discussion of the claims processing system is found in Chapter 5.
4. The System of Records for the WTC Health Program is housed within the claims processing system, which contains file links to scanned images of source member enrollment and certification paperwork. The System of Records Notice may be found at: https://www.cdc.gov/SORNnotice/09-20-0147.htm and was last updated in June 2011 (76 Fed. Reg. 34706 (June 14, 2011)).

10. Appeals of Medical Denial Decisions

In accordance with the PHS Act, an appeals process has been developed in 42 C.F.R. § 88.21 to provide Program members with a process to contest certain certification decisions. Program members may appeal the following decisions made by the WTC Health Program: (1) a decision not to certify a health condition as a WTC-related health condition; (2) a decision not to certify a health condition as medically associated with a WTC-related health condition; (3) a decision to decertify a WTC-related health condition or a health condtion medically associated with a WTC-related health condition; or (4) a decision not to authorize treatment due to a determination by the WTC Health Program that the treatment is not medically necessary for the certified health condition.

When a denial of health condition certification or a decision to decertify a health condition is issued by the Program, the member may appeal the decision. An appeal must be made in writing within 120 calendars days from the date of the WTC Health Program’s letter notifying the member of the denial or decertification decision. The written, signed appeal request should include a full explanation of why the member (or the member’s designated representative) believes that the denial decision is incorrect. See Overview of the Appeal Process for Denial of Health Condition. The following mailing address or fax number should be used to submit a request for appeal:

Appeal Coordinator
WTC Health Program
Po Box 7000
Rensselaer, NY 12144
Fax: 1-404-471-8338

1. Within 14 days of receiving an appeal request, the appeals coordinator will notify the individual by letter whether the appeal request is accepted or not. If the appeal request is accepted, the letter will provide the individual with the name of the Federal Official who will review the appeal. If the appeal request is not accepted, the letter will inform the individual and provide the reason(s) the appeal was not accepted.
2. An individual may request the opportunity to make an oral statement to the Federal Official during the appeal review within the appeal request letter to the appeals coordinator. The individual may also request to make an oral statement within 14 calendar days of receiving the letter from the appeals coordinator notifying him/her that the appeal request was accepted.
3. The Federal Official will review the appeal. If the appeal review is going to take longer than 60 calendar days from the date of the letter notifying the individual that his/her appeal request was accepted, the appeals coordinator will send a letter to the individual providing a written explanation of the delay and the estimated date the review is expected to be completed.
4. The Federal Official will review all available records and assess whether the appeal should be granted. The Federal Official may consider additional relevant new information and will provide a recommendation to the Administrator of the WTC Health Program. After receipt of the Federal Official’s recommendation, the Administrator will make a final decision on the appeal. The Administrator will notify the member and/or designated representative in writing of the decision and an explanation of the reason(s) for the decision, as well as any actions taken by the WTC Health Program resulting from the decision.
5. Pursuant to 42 C.F.R. § 88.25(c), the Administrator of the WTC Health Program is permitted to reopen a final determination at any time and to affirm, vacate, or modify that determination in any manner the Administrator deems appropriate.

Appendices

3-A WTC-3 Form
3-B WTC-3 Instructions for Cancer
3-E Making a Determination about Exposure Aggravating Pre-Existing Aerodigestive Disorders
3-F Time Intervals for New Onset Aerodigestive Disorders
3-G Policy and Procedures for Certification of Physician Determinations for Aerodigestive and Cancer Health Conditions
3-H Minimum Latency & Types or Categories of Cancer
3-I Malignant Neuroendocrine Neoplasms
3-J Myeloid Malignancies
3-K Rare Cancers
3-L Policy and Procedures for Handling Submissions and Petitions to Add a Health Condition to the List of WTC-Related Health Conditions
3-M Policy and Procedures for Adding Non-Cancer Conditions To the List of WTC-Related Health Conditions
3-N Policy and Procedures for Adding Types of Cancer To the List of WTC-Related Health Conditions

Chapter 4- Medical Benefits

1. Purpose and Scope

The purpose of this chapter is to describe the medical benefits that are available through the WTC Health Program under the James Zadroga 9/11 Health and Compensation Act of 2010 (the Act), responsibilities in the provision of medical benefits, the types of medical treatment provided, communications regarding medical benefits, appeals of medical necessity decisions, the process for requesting changes to medical treatment that is permitted under the WTC Health Program, and unique considerations relative to certain permitted services.

2. Statutory and Regulatory References

The following Sections of the Act are applicable to this Chapter:

1. Section 3311 (b) of the Act authorizes monitoring benefits for WTC responders;
2. Section 3312(b)(1)(A)(ii) provides that – assuming certain conditions are met – the WTC program will pay for medically necessary treatment for WTC-related health conditions;
3. Section 3312(b)(3) provides that treatment under the WTC Health Program must be medically necessary and in accordance with treatment protocols established under the Program. It also provides for the issuance of regulations specifying a standard for determining medical necessity for health care services and prescription pharmaceuticals, a process for determining whether the standard is being met, and a process for appealing Program decisions regarding medical necessity;
4. Section 3321 (b) provides for initial health evaluations (screening) for screening-eligible WTC survivors; and
5. Section 3322 allows for follow-up monitoring and treatment of certified-eligible WTC survivors.

Relevant regulatory sections from 42 C.F.R. Part 88 include § 88.11; 88.17; 88.20; 88.21; 88.22.

3. Responsibilities

The parties involved in providing WTC Health Program medical benefits and their responsibilities are detailed below:

1. The Clinical Centers of Excellence (CCEs) and the Nationwide Provider Network (NPN) provide monitoring and initial health evaluations for eligible responders and survivors. The CCEs/NPN also provide treatment for certified WTC-related and medically associated health conditions, and make referrals for treatment to other medical experts (external network providers) that are affiliated with the CCEs/NPN as part of their program-related provider networks. The CCEs/NPN provide medical services to WTC Health Program members, including treatment, writing and approving prescriptions, and providing prior authorizations when necessary. The CCEs/NPN authorize medical treatment that is consistent with established treatment protocols and review claims for payment from external network providers to ensure adherence to coding requirements and Program guidelines. The CCEs/NPN document decisions requiring prior authorization from their respective CCE /NPN Clinical Directors and submit information to the program for services that require prior authorization from the WTC Health Program Medical Benefits Manager. For pharmacy benefits, the CCEs/NPN provide prior authorization or perform overrides for certain medications (see Chapter 14 for further details). Further information regarding the CCEs’ responsibilities, including provider enrollment, may be found in Chapter 6 of this manual.
2. The Health Program Support (HPS) contractor is responsible for receiving and processing claims for medical benefits, enrolling network providers in the WTC Health Program, processing requests for prior authorization from the WTC Health Program Medical Benefits Manager, providing technical assistance with the medical change control process, providing expert research and recommendations to inform policy decisions, ensuring that medical claims are processed in accordance with Program policy, and providing communications support regarding Program medical policy, as well as appeals arising from denials of treatment due to medical necessity.
3. The Administrator of the WTC Health Program or designee (i.e., WTC Health Program Medical Benefits Manager) establishes medical and pharmacy policy for the Program, certifies health conditions for treatment, establishes a process for members’ appeals of medical denials and designates a Federal official independent of the WTC Health Program to review member appeals, considers additions of health conditions to the List of WTC-Related Health Conditions (List), and conducts any necessary rulemaking. The Administrator of the WTC Health Program or designee also authorizes requests for certain levels of prior authorization (PA), as discussed in Section 11 of this chapter.

4. Covered Medical Services

Medical services covered by the Act span treatment services, monitoring services, and evaluation/screening services for the conditions specified in the Act and 42 C.F.R. § 88.15, as well as any other condition added to the List through rulemaking procedures specified by the Act.

1. Medically Necessary Treatment

   The Act states in Section 3312(b)(3)(A), “In providing treatment for a WTC-related health condition, a physician or other provider shall provide treatment that is medically necessary and in accordance with medical treatment protocols….” Medical treatment protocols, also referred to as “medical guidelines,” are developed by the Data Centers (DCs) in accordance with accepted medical practice and recommendations from professional organizations, such as the American Medical Association, American College of Chest Physicians, and the like. The protocols are subsequently approved by the Administrator of the WTC Health Program or designee for use with WTC Health Program members. Protocols are maintained by the DCs, CCEs, and NPN, as well as in WTC Health Program’s official file of record.

   Section 3312(b)(3)(B) requires that the Administrator of the WTC Health Program issue regulations specifying a standard for determining medical necessity, a process for determining whether the standard is being met, and an appeals process for the Program’s decisions of medical necessity. These regulations are found in 42 C.F.R. §§ 88.20 and 88.21.

2. Scope of Treatment Services

   Section 3312(b)(4)(A) states, “The scope of treatment covered under this subsection includes services of physicians and other health care providers, diagnostic and laboratory tests, prescription drugs, inpatient and outpatient hospital services, and other medically necessary treatment.”

   Section 3312(b)(4)(C) authorizes the Administrator of the WTC Health Program to provide for “necessary and reasonable transportation and expenses incident to the securing of medically necessary treatment through the nationwide network … involving travel of more than 250 miles ….” Relevant regulations regarding travel expenses are found at 42 C.F.R. § 88.2(b).

3. Monitoring Benefits

   Sections 3311(b) and 3321(b)(1) authorizes monitoring benefits for enrolled WTC responders and certified-eligible survivors, respectively. These monitoring benefits consist of periodic (yearly) medical examinations and long-term health monitoring and analysis. Monitoring benefits are provided through the CCEs, or for enrolled members who live outside of the New York metropolitan area, the Nationwide Provider Network. The purpose of medical monitoring is to identify diseases of concern for early intervention, to characterize the health of the program members over time, to facilitate efforts for continuous quality improvement in the healthcare rendered by the program, and to inform emergency preparedness efforts for future disasters.

4. Initial Health Evaluations

   Section 3321(b) of the Act provides for an initial health evaluation (screening) for screening-eligible WTC survivors. The purpose of the screening is to determine whether the individual has a WTC-related health condition and is eligible for follow-up monitoring and treatment benefits under the WTC Health Program. Unlike annual monitoring exams, the screening is a one-time evaluation. However, the individual may seek additional screenings at his or her own expense. Once a health condition is certified, the member’s status changes to certified-eligible survivor and they are authorized according to §3321(b)(1) to receive annual medical monitoring and medically necessary care to manage that condition following the medical protocols approved by the program. Relevant regulatory language is found at 42 C.F.R. §§ 88.11 and 88.12.

5. Approved Medical Procedure Codes

   The WTC Health Program Codebook, Vol. A, lists the medical procedure codes approved for use within the Program, organized by health plan option, as described in the below table. The WTC Health Program offers multiple health plan options, based on the member’s status as defined in the Act (e.g., responder, survivor, or FDNY family member) and his/her health condition(s). The health plan options include procedures for the initial health evaluation for survivors, annual medical monitoring for responders and certified-eligible survivors, diagnostic evaluation to enable a nonspecific symptom or abnormal finding to be properly diagnosed for the purpose of certification, and treatment plans organized by the category of health condition certification.

   The WTC Health Program Codebook, Vol. A, includes codes for office visits for evaluation and management, diagnostic and surgical procedures, laboratory and other medical testing and imaging studies, and durable medical equipment (DME). The codes are aligned to “Care Suites,” groupings developed by the WTC Health Program which define the acceptable range of treatments for any WTC Health Program-eligible medical condition (described further in section H, below). The procedure codes arise from standard coding references including the American Medical Association’s (AMA’s) Current Procedural Terminology (CPT®) and the Centers for Medicare and Medicaid Services’ (CMS’) Healthcare Common Procedural Coding System (HCPCS), DME, Diagnosis-related Group (DRG), and Revenue Coding Center (RCC) codes. Vol. A is reviewed and updated on a regular basis and is provided to the CCEs and NPN.

   Member Status	Medical Benefit Plan	Pharmacy Benefit
   Screening-eligible survivor	One time health screen; Diagnostic (6 months)	Diagnostic (3 months)
   Certified-eligible survivor	Monitoring; Diagnostic; Care Suite(s) based on condition(s) certified	Standard treatment if certified for WTC-related non-cancer condition; Diagnostic; Cancer if certified
   General & FDNY Responder	Monitoring; Diagnostic; Care Suite(s) based on condition(s) certified	Standard treatment if certified for WTC-related non-cancer condition; Diagnostic; Cancer if certified
   FDNY Family	Mental Health Care Suite if certified	Mental Health if certified
   Shanksville responder	Monitoring; Diagnostic; Care Suite(s) based on condition(s) certified	Standard treatment if certified for WTC-related non-cancer condition; Diagnostic; Cancer if certified
   Pentagon responder	Monitoring; Diagnostic; Care Suite(s) based on condition(s) certified	Standard treatment if certified for WTC-related non-cancer condition; Diagnostic; Cancer if certified

6. Cancer Treatment Protocols

   In general, treatment protocols for cancer under the WTC Health Program follow the National Comprehensive Cancer Network (NCCN) Guidelines, which may be found at http://www.nccn.org/clinical.asp.

7. Prescription Drug Formulary

   The WTC Health Program Codebook, Vol. C, is the Prescription Drug Formulary established by the Program. Vol. C lists the prescription drugs that have been approved for use in the Program. For most prescription drugs, the WTC Health Program requires the use of generic medication unless a brand name product is required due to medical necessity. The Formulary is reviewed and updated on a regular basis and provided to the CCEs and NPN. The medications that are allowed for an individual member depend on the pharmacy benefit plan to which he/she is assigned. The following chart shows the different plans and basis for assignment:

   Pharmacy Benefit Plan Name	Eligibility Criteria for Plan Assignment	Formulary Content	Plan Use Limitations
   Diagnostic Pharmacy Plan (Dx)	Enrolled Responders (except FDNY Family) and Survivors regardless of certification status NOTE: This excludes enrolled family of the fallen FDNY firefighters	Includes Inhalers Antibiotics Proton pump inhibitors H2 blockers Saline wash Medications to support covered cancer screening Supportive medications during cancer work-ups	Closed prescriber network 30 day supply limit per fill Maximum benefit = 90 day supply Generic medication will be utilized, only excepted in rare instance, which is indicated in the formulary by listing the Brand
   Standard Treatment Pharmacy Plan (STx)	Enrolled Responders (except FDNY Family member) or Responder with at least 1 certified health condition	Includes medications to address covered aerodigestive, musculoskeletal/acute traumatic injury, and mental health conditions	Closed prescriber network Generic medication will be utilized, only excepted in rare instance, which is indicated in the formulary by listing the Brand Mail order preferred for chronic maintenance therapies Prior authorization (PA) required for medications to manage medically associated conditions (e.g., diabetes, hypertension, heart dysrhythmias) and other higher tier/specialty meds Limited to 90 day supply max per fill
   FDNY Family Mental Health Treatment Pharmacy Plan (FMH)	FDNY Family members– if certified for a mental health condition, otherwise default to no pharmacy benefit	Subset of standard treatment pharmacy plan, to address mental health conditions in surviving FDNY family members only	Closed prescriber network Generic medication will be utilized, only excepted in rare instance, which is indicated in the formulary by listing the Brand Mail order preferred for chronic maintenance therapies Limited to 90 day supply max per fill
   Transplant Pharmacy Plan (Txp)	Member with a certified condition resulting in WTC Health Program authorization for organ transplantation	Includes medications to cover the range of complications involved	Closed prescriber network Generic medication will be utilized, only excepted in rare instance, which is indicated in the formulary by listing the Brand Mail order preferred for chronic maintenance therapies Limited to 90 day supply max per fill
   Cancer Treatment Pharmacy Plan (CaT)	Members who are certified for cancer	Includes broad set of therapeutic classes to address the range of conditions associated with cancer, and for other, co-morbid/medically associated WTC-related health condition coverage For cancer care, includes anti-neoplastic and support medications	Open prescriber network Generic medication will be utilized, only excepted in rare instance, which is indicated in the formulary by listing the Brand Mail order preferred for chronic maintenance therapies No PA requirements (currently removed) Quality assurance requirement - weekly retrospective drug utilization review by CCE, with auditable documentation and rectification of identified problems First time fill requests for therapeutic classes other than anti-neoplastic will be limited to no more than a 30 day supply (to give time for quality assurance activities) Anti-neoplastic regimens as per NCCN guidelines

8. Care Suites

   Treatment services for a WTC-related health condition or a health condition medically associated with a WTC-related health condition are grouped into more specific benefit plans called Care Suites. The categories of health conditions are currently defined by ICD-10 diagnosis codes. Once approved for certification, the member is assigned to a Care Suite that correlates with a specific category of certified conditions. The medical services associated with each covered condition/diagnosis code are defined by CPT, HCPCS, DRG, and RCC codes.

   The table below provides an example of some of the Care Suite diagnosis codes for one particular type of WTC Health Program-related health condition, Gastroesophageal Reflux Disorder (GERD).

   WTC Health Program Covered Condition	Related ICD-10 Code	ICD-9 Code Description
   Gastroesophageal Reflux Disorder	J39.2	Diseases of Pharynx- Other
   	K20.0	Esophagitis- Eosinophilic
   	K20.8	Esophagitis- Other
   	K21.0	Gastro-esophageal reflux with esophagitis
   	K21.9	Gastro-esophageal reflux without esophagitis
   	K29.30	Chronic superficial gastritis without bleeding
   	K29.31	Chronic superficial gastritis with bleeding
   	K29.40	Chronic atrophic gastritis without bleeding
   	K29.41	Chronic atrophic gastritis with bleeding
   	K29.50	Chronic gastritis without bleeding – Unspecified
   	K29.51	Chronic gastritis with bleeding - Unspecified
   	K29.60	Other gastritis without bleeding
   	K29.61	Other gastritis with bleeding
   	K29.90	Gastroduodenitis without bleeding - Unspecified

   The Care Suites provide an important fiscal control for the Program by defining additional business rules guiding the adjudication of healthcare claims for payment. The examining physician submits information on a specific health condition to the WTC Health Program to review for certification (see Chapter 3, Certification of Health Conditions). The Care Suites provide the medical coding for all medically necessary care to manage the certified health condition. The Care Suites enable the claims adjudication process to approve the appropriate care for that health condition, but withstand the variability that may occur between providers or referral specialists using different specific diagnosis codes when billing for procedures. The conditions listed within a category either share target symptoms (like cough), or share a mechanism of injury (like inflammation) within a given organ system.

   Each Care Suite has one or two “certification gates” which define the type of condition for which the member is treated.

   • Certification gate 1 refers to a WTC-related health condition along with medically associated health conditions within the same organ system.
   • Certification gate 2 refers to medically associated health conditions impacting additional organ systems or those within the original organ system which may require a higher level of care to manage. A gate 2 condition requires additional certification by the WTC Health Program as a health condition medically associated with a WTC-related health condition, as described in 42 C.F.R. §§ 88.1, 88.17(b), and 88.18(b). The gate 2 condition would be certified as being medically associated with the gate 1 certified WTC-related health condition.

   Care Suite certification gates are assigned to each member profile to match all health conditions that have been certified. The member profiles continue to be updated as new health conditions are certified for a given member. The claims processing system compares the diagnosis on a claim against the certification gate for the member’s health condition, and verifies that the diagnosis on a claim is among the accepted diagnoses within a certification gate and that no additional certification is necessary. This process provides important checks and balances to ensure only approved care is delivered under the WTC Health Program. The following Care Suites are currently in use by the Program (not a complete list):

   1. “Survivor Screening Care Suite” contains codes for the initial health evaluation for screening-eligible survivors. This evaluation includes a standard protocol of medical and exposure questionnaires, laboratory testing of blood and urine, lung function tests, electrocardiogram, chest radiograph, mammography, colonoscopy, and a physical examination.
   2. “Responder Initial Visit Care Suite” contains codes for the initial medical monitoring examination for responders. This examination includes a standard protocol of medical and exposure questionnaires, laboratory testing of blood and urine, lung function tests, electrocardiogram, chest radiograph, mammography, colonoscopy, and a physical examination.
   3. “Periodic Medical Monitoring Care Suite” contains codes for the annual medical monitoring examination for responders and certified-eligible survivors. This examination includes a standard protocol of medical questionnaires, laboratory testing of blood and urine, a lung function test, electrocardiogram and chest radiograph (when indicated), mammography, colonoscopy, and a physical examination.
   4. “Diagnostic Care Suite” contains diagnostic evaluation services and limited access to formulary medications to assist the provider in rendering a diagnosis with a reasonable level of clinical certainty. The services are intended to provide limited coverage beyond the screening or monitoring protocol when there is a significant exposure history and an unclear diagnosis. The clinical determination is then submitted to request certification from the Program, or the WTC Health Program is referred for outside care, if the diagnosed health condition is not WTC-related. If referred out, the member is informed that the referral and subsequent care for that health condition will not be covered by the Program.
   5. “Cancer Diagnostic Care Suite” contains additional procedures if further diagnostic workup (beyond what is already included in the monitoring, screening, and diagnostic plans) is required to determine whether a member has a cancer that is potentially covered under the Program. The CCE/NPN must request that the member be added to the Cancer Diagnostic Plan. CCEs/NPN should make such requests only when the member had Tier 1 and/or Tier 2 exposures (types of activities leading to exposure) and meets the minimum exposure duration requirements (pursuant to the supplemental information titled “Instructions for Completing WTC-3 Package Requesting Certification for Types of Cancer,” Appendix 4-A). CCEs/NPN should communicate their request to add the member to the Cancer Diagnostic Plan in writing to the Program and include the following elements in their communication:
      • Patient name
      • Program ID
      • CCE/NPN
      • Date cancer diagnostic services are being initiated
      • Chief complaint or abnormal finding being evaluated
      • Approving physician signature (CCE/NPN designates)

      The CCE/ NPN submits this information to the Program via fax or electronically through the secure server. In submitting this plan the CCE/ NPN acknowledges that the member has met the minimum exposure and duration requirements. Upon receipt of all required information, the Member Services Team will update the system to add the Cancer Diagnostic Plan to the member’s record.

   6. “Certified Care Suites” are defined by the category to which a certified health condition is assigned. These care suites contain the range of services required to provide medically necessary care for a certified condition, as per Program treatment guidelines.
9. Updating the Codebook and Care Suites

   The Codebook and Care Suites undergo frequent revisions and CCE/ NPN and Program staff are required to use the most current versions. In addition, because of these frequent revisions, when referencing any procedure or diagnosis codes cited in this manual, the most current version of the codebooks should be consulted to determine if the code is still valid.

5. Medical Monitoring

Survivors with a certified WTC-related health condition(s) (certified-eligible survivors) and all responders are eligible for the monitoring plan, which consists of several elements. Eligible members have access to all the cancer and non‐cancer diagnostic codes included in this plan as part of their yearly monitoring exam. The Program has customized the ICD-10 code Z04.9 (Encounter for examination and observation for unspecified reason) to indicate to the claims processing system that a given procedure is part of the standard monitoring exam. This code includes the following elements:

1. Initial monitoring examination, including completion of a set of detailed questionnaires covering 9/11 exposure, health complaints, and medical history along with health education counseling by a registered nurse.
2. Follow-up monitoring examinations, one per year. The follow-up exam reassesses for health complaints and the intervening medical history occurring since the prior monitoring exam. Both the initial and follow-up examinations also include items C-F below.
3. Laboratory analyses of blood. Comprehensive metabolic panel, complete blood count, and lipid panel - one per year. A few additional blood work tests are also permitted, one per year.
4. Urinalysis, one per year.
5. Medical testing. Spirometry, one per year. Spirometry with bronchodilation is to be performed on the initial visit only. Chest radiography will be conducted every two years, unless the monitoring exam indicates otherwise. Separate billings for technical and professional components may be submitted for these medical tests.
6. EKG, one per year if the member is over 45 years of age, unless the monitoring exam indicates otherwise.
7. Screening Colonoscopy for members aged 50 and over, with limitations on frequency according to the procedure performed.
8. Screening Mammogram, one per year for female members aged 40 and over.

6. Screening Examinations

Screening examinations are provided only to WTC survivors as their initial health evaluation within the Program. Eligible survivors have access to all of the cancer and non-cancer screening codes included in the Survivor Screening Care Suite as part of their one‐time, no cost health evaluation covered under the Act. The following services are part of a screening examination, using ICD-10 code Z13.9 (Encounter for screening, unspecified) for billing purposes.

1. Screening examination, including a detailed set of questionnaires evaluating 9/11 exposure, health complaints, and medical history, using the age-appropriate code.
2. Laboratory analyses of blood including a comprehensive metabolic panel, lipid panel, and complete blood count.
3. Urinalysis.
4. Chest x-ray, and spirometry (with or without bronchodilation).
5. EKG
6. Screening colonoscopy for members aged 50 and over.
7. Screening mammogram for female members aged 40 and over.

7. Authorization of Treatment Pending Certification

While certification is pending, authorization for treatment of a WTC-related health condition or health condition medically associated with a WTC-related health condition may be requested at the CCE/NPN physician’s discretion through the WTC-3 Form. The purpose of this authorization is to ensure continuity of appropriate medical care that is time sensitive and consistent with Program policy. Such authorization must be obtained from the WTC Health Program before treatment is provided, except for the provision of treatment for a medical emergency 42 C.F.R. § 88.20 (c).. Treatment rendered after WTC-3 submission but prior to certification will only be covered if the request for treatment pending certification was included in the WTC-3 submittal The request for treatment pending certification is indicated on the WTC-3 by checking the box appropriately indicating the request, and is ultimately granted, and the treatment provided is medically necessary, does not require Level 2 or 3 Prior Authorization, follows Program guidelines, and is rendered by a CCE/NPN-affiliated provider. In the event that the condition is denied certification, any care provided for the health condition that is outside the parameters of the Diagnostic Plan will not be covered and the CCE or NPN providing the care will be responsible for the costs of such care. (See Chapter 3 for further information.)

If the certification request is determined to be unsatisfactory, then the authorization for treatment pending certification is discontinued immediately and related claims are pended for up to three weeks, during which time the CCE or NPN will work with the HPS’ Member Services Team to rectify any deficiencies in the request, if possible. After 3 weeks, unsatisfactory certification requests will convert to a denial of certification and appropriate Program actions (see Chapter 3 for further information).

8. Cancer Diagnosis and Treatment

When a CCE or NPN physician determines that a member’s 9/11 exposures are substantially likely to have been a significant factor in aggravating, contributing to, or causing the development of a cancer condition, the physician may request certification of the member’s health condition with the submission of a WTC-3 certification request. To assist the CCE or NPN provider with certification requests for cancer conditions, a supplemental information packet has been developed entitled “Instructions for Completing WTC-3 Package Requesting Certification for Types of Cancer.”(see Appendix 4-A).

1. Cancer Diagnostic Plan

   When a member is determined by a CCE or NPN health provider to have an abnormality which merits diagnostic evaluation for a possible WTC-related cancer, the Diagnostic Plan is used. The Diagnostic Plan is assigned to all enrolled responders (except FDNY family members), and is also available to enrolled survivors during the initial screening period (6 months), and if the member has a certified health condition, on a continuous basis along with the Monitoring Plan benefits As of April 26, 2013, the Standard and Cancer Diagnostic Plans have been combined, and the WTC-4 form has been discontinued.. CCE and NPN physicians are expected to use their clinical judgment to determine when clinical, laboratory, or imaging findings merit further evaluation for a possible WTC-related cancer, and should take into consideration the exposure history of the member, as well as noting the likelihood of finding a form of cancer that is known to be covered by the WTC Health Program.

   The services (procedure codes) that are permitted for cancer under the Diagnostic Plan are found in the WTC Health Program Codebook, Vol. A. The ICD-10 code Z12.9, defined as “Encounter for screening for malignant neoplasm – site unspecified,” may be used to indicate that a particular service is being billed for cancer under the Diagnostic Plan. An allowable procedure can point to Z12.9, either as the sole pointer or along with whatever ICD-10 code the provider usually uses for billing. The CCE/NPN can utilize Z12.9 as an authorization code when the entire claim is being authorized under the Diagnostic Plan by adding Z12.9 to either the paper CMS-1500 or the electronic version. In addition, numerous ICD-10 condition codes (some that correlate with various signs and symptoms that could be indicative of cancer) may be used for services billed under the Diagnostic Plan. These allowable condition codes (ICD-10) are listed in the WTC Health Program Codebook.

2. Cancer Treatment Plan

   Once a member has been certified as having a WTC-related cancer, the member is assigned a Cancer Treatment Plan. The Cancer Treatment Plan contains the medical services (procedure codes) and medications necessary to treat cancer. The procedure codes for these services are found in the WTC Health Program Codebook, Vol. A. The cancer diagnosis (ICD-10) codes used in conjunction with cancer claims are also found in the WTC Health Program Codebook. The National Comprehensive Cancer Network has developed “Clinical Practice Guidelines in Oncology” (NCCN Guidelines) for cancer treatment. To the extent practical and possible, these guidelines will be used to guide cancer treatment under the Program. The NCCN Guidelines are found at: http://www.nccn.org/clinical.asp.

9. Decisions and Appeals

Approval of a request for coverage is handled in accordance with the procedures described in Chapter 3 of this manual. Decision letters are written in clear and concise language. Letters of approval indicate the category/categories of coverage for which the member has been approved. If the decision is a denial, the letter includes an explanation of the reason for the denial and the avenues of appeal that are available. See Chapter 3 for more discussion of the appeal process.

10. Medical Change Management

To ensure members receive ongoing high-quality care, the Program maintains a mechanism for making necessary changes to its medical management processes.

1. WTC Health Program-initiated changes in health condition coding and covered treatment coding are made on an ongoing basis, due to a variety of causes, including updates to codes made by the organizations that own the codes (i.e., American Medical Association and the Centers for Medicare and Medicaid Services), new treatment options, and refinement of treatment protocols.
2. Changes requested by a CCE/NPN are submitted via email by the CCE/NPN Clinical Director for review and decision by the WTC Health Program Medical Benefits Manager (MBM). CCEs or the NPN may determine that a procedure, diagnosis, medical product, or medication is necessary for quality patient care, but is not currently covered under the Program. In these instances, the CCE/NPN may request coverage for these services or diagnosis through the Medical Services Change Management Process. Such requests should come from or with the approval of the CCE/NPN Clinical Director. If an external provider requests a change, they must do so through their respective CCE/NPN Clinical Director. Guidance on the standard information required in requesting these changes is shown in Appendix 4-B. The process for approval or denial of medical changes is described as follows:
   1. The MBM will communicate with the submitting CCE/NPN if additional information is needed to make a decision regarding whether to approve the change. If the request is approved:
      1. The requestor and other CCEs/NPN are notified of the approval;
      2. The HPS' Member Services Team, Systems Team, and Call Center are notified of the change;
      3. The WTC Health Program Codebook is updated to reflect the change;
      4. The claims processing system is updated to include the change;
      5. The change is posted on Engage; and
      6. The change is included in the “Summary of Changes” that accompanies the subsequent Codebook Update Bulletin.
   2. If the request is denied, the requesting CCE/NPN is notified of the denial and the reasons for the denial.
3. The timeline for implementing a change request is one to two weeks from the date the request is approved or receipt of all necessary information, whichever is later.

11. Prior Authorization

Certain medical services require prior authorization (PA), either by the respective CCE/NPN Clinical Director, and/or by the WTC Health Program MBM.

1. Required PAs Designated in Codebooks

   The procedures, services, DME, and medications that require PA are so designated in the codebooks.

2. Levels of PAs

   A Level 2 PA requires authorization by the CCE/NPN Clinical Director; a Level 3 PA requires authorization by the WTC Health Program MBM. Medical services that do not require PA are considered Level 1.

3. Documentation of PAs

   For procedures that require Level 2 PA, documentation of medical necessity and approval by the CCE/NPN Clinical Director must be maintained either in the member’s medical record or other CCE/NPN tracking system. The documentation is subject to audit, and the Program performs periodic utilization reviews to ensure compliance. No further notification to the WTC Health Program is required for Level 2 PAs, since the CCE/NPN stamp on a paper-based or electronically-submitted medical claim (described in Chapter 5) reflects the CCE/ NPN acknowledgement that the claim is valid in accordance with all WTC Health Program requirements, including those related to PAs. The Program will maintain written documentation of all Level 3 PAs authorized by the WTC Health Program MBM or designee.

4. Level 3 PAs
   1. Prior to performing a service that requires Level 3 PA, the CCE/NPN must receive a Level 3 PA from the WTC Health Program MBM or designee. If the Level 3 PA is not received, the WTC Health Program will not provide payment for the service.
   2. Medical services will generally be authorized as a single service unless otherwise requested by the CCE/NPN in the authorization request. The rationale for additional services must be included in the medical justification. For PA requests extending beyond a single service, the CCE/NPN must specify an authorization date range and intended quantity (or unit) of service. If quantities/units are not known, the WTC Health Program MBM or designee will establish reasonable quantities for these services per authorization.
   3. The HPS’ Member Services Team reviews the request to ensure that the procedure code is a service that requires PA by the Program MBM and, if so, that the PA request is logged into a tracking log. The information is then forwarded to the MBM or designee for review and approval. If approved, the Level 3 PA information is entered into the claims processing system by the HPS’ Claims Team, linking the request and any supplemental information to the member record.
   4. If the PA request is incomplete, the claims are pended and the HPS requests the missing information from the originating CCE/NPN. Claims pended for this reason are subsequently denied if the information is not received within 14 days of CCE/NPN notification.
   5. The Program notifies the CCE /NPN Clinical Director of the approval/denial of the Level 3 PA requested service as soon as possible, generally within 24 hours of the decision. Claims for Level 3 PA services that are not approved by the Program MBM or designee will be denied due to missing authorization.

12. Transplants

WTC Health Program policies regarding organ and tissue transplants are consistent with best clinical practices and national guidelines, and include the following considerations.

1. Prior Authorization

   When a transplant is being considered, the CCE/NPN Clinical Director must request authorization from the WTC Health Program MBM for pre-transplantation medical testing. Part A (and as much of Part B as is known) of the “Transplant Authorization Request” form (Appendix 4-C) must be completed by the CCE/NPN Clinical Director and transmitted to the WTC Health Program Medical Benefits Manager for review. The CCE/NPN Clinical Director must indicate the pre-transplantation testing planned and any additional steps required to assess transplant feasibility.

2. Basis for Permitting Transplants

   The transplant must be non-experimental and non-investigational. The specific medical condition being treated must have been certified for the member by the WTC Health Program, and must be a contributory cause, as determined by the WTC Health Program MBM based upon the available scientific information, leading to the deterioration of the organ or tissue being transplanted.

3. Pre-Transplantation Testing, Evaluation, and Recommendation
   1. Pre-transplantation tests and evaluations will be covered under the Program after review and approval by the WTC Health Program MBM. Approval of the work-up does not guarantee approval of the organ or tissue transplant.
   2. Upon completion of tests/evaluation, the CCE/NPN Clinical Director must provide the WTC Health Program MBM with the test/evaluation results and a qualifying facility’s transplant board recommendations for next steps. A facility is considered qualified when it has been approved by CMS as a transplant facility for the specified organ or tissue by the state in which the facility is located.
   3. If a transplant is recommended by the facility’s transplant board, Part C of the “Transplant Authorization Request” form must be completed by the CCE/NPN Clinical Director, as well as complete information for Part B, if not provided previously.
4. CCE/NPN Request for Transplant

   The request for a transplant must be supported with:

   1. Medical necessity documentation, a summary of the transplant work-ups/results given to the facility’s transplant board, and the board’s findings.
   2. Conclusive evidence from reputable peer-reviewed medical literature supporting that the transplant will have a positive health outcome that outweighs any harmful effects of the transplant. This evidence may include:
      1. Evidence and/or investigations by nonaffiliated authoritative sources; and/or
      2. Measurable results.
   3. Additional required documentation for all transplant requests:
      1. The provider must document in the request for transplant that the member is unresponsive to more conventional and/or standard therapies;
      2. Compliance with other medical treatments, regimens, and plans of care must be documented. Documented compliance includes no active alcohol or chemical dependency that interferes with adherence to a medical regimen; and
      3. Documented psychiatric instability is a contraindication for transplantation if severe enough to jeopardize a member’s incentive to adhere to a given medical regimen.
5. Special Requirements for Lung Transplant Request

   Where a lung transplant is requested, the facility must additionally document the following in the transplant request:

   1. A critical medical need with a likelihood of successful clinical outcome;
   2. Symptoms at rest directly related to chronic pulmonary disease and resultant severe functional limitation;
   3. Documentation of end-stage pulmonary diseases in these categories:
      1. Restrictive lung disease;
      2. Obstructive lung disease;
      3. Pulmonary hypertension; and
   4. An absence of co-morbidities such as:
      1. End-stage renal, hepatic, or other organ dysfunction unrelated to primary disorder; and
      2. Multiple organ compromise secondary to infection, malignancy, or condition with no known cure.
6. WTC Health Program Review of Transplant Request
   1. The WTC Health Program Medical Benefits Team will review the Part B information provided and verify that the provider is enrolled in the WTC Health Program and practices at a CMS-approved transplant facility.
   2. The WTC Health Program Medical Benefits Manager will review all professional recommendations and documentation provided, and render an approval or denial determination.
7. Transplant Request Denials

   Denials of requests for transplants are subject to appeal by the member, pursuant to regulation, as a denial of medically necessary treatment. Appeal rights will be provided when the outcome of the Program evaluation is a denial decision (see Chapter 3 for additional information on appeals).

13. Treatment for Sleep Apnea

Sleep apnea The most common type of sleep apnea is obstructive sleep apnea (OSA). In this condition, the airway collapses or becomes blocked during sleep. Central sleep apnea is a less common type of sleep apnea which occurs if the area of your brain that controls your breathing doesn't send the correct signals to your breathing muscles. Central sleep apnea is more common in people who have certain medical conditions or use certain medicines. See http://www.nhlbi.nih.gov/health/health-topics/topics/sleepapnea/ for more information. Central sleep apnea can occur with obstructive sleep apnea or alone. may be approved for coverage under the WTC Health Program in two scenarios. Sleep apnea exacerbated by or related to another covered WTC-related aerodisgetive disorder (interstitial lung disease, chronic respiratory disorder [fumes/vapors], asthma, reactive airways dysfunction syndrome [RADS], WTC-exacerbated chronic obstructive pulmonary disease [COPD], chronic cough syndrome, upper airway hyperactivity, chronic rhinosinusitus, chronic nasopharyngitis, chronic laryngitis, and gastroesophageal reflux disorder (GERD) is a health condition specifically included on the List of WTC-Related Health Conditions and may be covered as such PHS Act, Section 3312(a)(3)(A)(xii) and 42 C.F.R. § 88.15, List of WTC-Related Health Conditions.. Alternatively, sleep apnea may be certified if it is shown to be medically associated with another certified WTC-related health condition (including or other than an aerodigestive condition). Sleep apnea which is not either exacerbated by or related to a listed WTC-related aerodigestive condition or medically associated with another certified WTC-related health condition cannot be certified for coverage in the WTC Health Program.

1. Treatment of Symptoms

   For all WTC Health Program members with sleep apnea, every attempt should be made to optimize treatment of the WTC Health Program certified condition(s) prior to performing a sleep study. However, a sleep study may be performed earlier if sleep apnea is considered to be extreme and potentially life-threatening – for example, contributing to pulmonary hypertension, right heart failure, or respiratory failure.

   Once treatment of the WTC Health Program certified conditions has been maximized, if sleep apnea continues, then a sleep study may be authorized.

2. Diagnostic Testing for Sleep Apnea (Sleep Studies)

   A sleep study for suspected sleep apnea is covered under the WTC Health Program only if there is documentation from a previous monitoring exam of an aerodigestive disorder listed above. In addition, a sleep study may also be allowed where sleep apnea is suspected to be medically associated with a certified WTC-related health condition.

   A sleep study requires a Level 2 PA (per section 11 above) and may be covered only if one or more of the following symptoms are currently present, as documented in the Medical History Questionnaire:

   1. Excessive daytime sleepiness;
   2. Falling asleep while driving/eating/in the midst of conversation;
   3. Witnessed episodes of apnea while sleeping; and/or
   4. Frequent, loud snoring.

   There are different types of sleep studies, including the split test, the diagnostic test, and the titration test. For the WTC Health Program, the split test is preferred as the WTC Health Program covers sleep apnea and not other sleep diagnoses. Only in special circumstances should home tests be approved and only after consultation between the CCE/NPN Clinical Director and the sleep expert at that institution. The specific type of sleep test should be sufficient for either diagnosing or treating sleep apnea appropriately.

   Repeat sleep studies are covered only if there has been a significant change in the member’s clinical condition (such as substantial change in the member’s weight or underlying condition) or inability to use continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BIPAP) machines despite every effort to improve compliance, for calibrating CPAP settings, or to assess effectiveness of treatment, and require the approval of the CCE/NPN Clinical Director via a Level 2 PA.

   A sleep study must be provided and supervised by a WTC Health Program network physician specializing in sleep medicine at a network-approved sleep center. Approval of specialty providers such as sleep centers is discussed in more detail in Chapter 6. Claims for diagnostic sleep studies are processed and paid as outpatient services.

3. Treatment of Sleep Apnea Certified as a WTC-Related or Medically Associated Health Condition

   If the sleep study shows mild sleep apnea and the condition is subsequently certified by the Program, positive pressure mask therapy (CPAP/BIPAP) is covered by the WTC Health Program only if sleep apnea symptoms are severe (such as excessive daytime somnolence, fatigue, and headaches).

   If the sleep study shows moderate to severe sleep apnea and the condition is subsequently certified by the Program, CPAP/BIPAP therapy is covered under the WTC Health Program.

   In addition to prescribing a CPAP/BIPAP, if the patient’s Body Mass Index (BMI) is greater than or equal to 30, or there has been a 10 percent increase in weight over the last year, then three consultations with a nutritionist for weight reduction are covered under the WTC Health Program. Additional consultations with a nutritionist may be covered at the discretion of the CCE/NPN Clinical Director. Specialized food or surgery for obesity will not be covered.

   All providers (internal and external) must obtain Level 2 PA in writing from the CCE/NPN for all treatments, procedures, and DME related to sleep apnea.

4. Surgery

   Sleep apnea surgery (such as uvulopalatopharyngoplasty) is not covered under the WTC Health Program unless the patient has failed other therapy, has a life-threatening disease (e.g., pulmonary hypertension, right heart failure, respiratory failure) and the CCE/NPN Clinical Director approves the surgery via a Level 2 PA. <.p>

5. Dental Appliances

   Dental appliances are not covered under the WTC Health Program. In general, they are used in circumstances where there are jaw malformations, which are by definition not WTC-related. However, exceptions may be made on a case-by-case basis with Level 3 PA from the WTC Health Program Medical Benefits Manager, when evidence exists that a dental appliance is a viable treatment for the member’s sleep apnea The Program may consult with a dental Subject-Matter Expert in order to determine appropriateness of use..

6. Claims

   As previously noted, treatment equipment for sleep apnea, including CPAP and other DME, require Level 2 PA. A WTC Health Program covered condition must be included on the claim per the WTC Health Program Codebook, Vol. A, and the WTC Health Program covered condition must have led to the sleep apnea (as a medically associated condition) or the sleep apnea must be the WTC Health Program covered condition (exacerbated by a covered aerodigestive condition).

14. Family Psychotherapy With and Without the Member

In certain circumstances, psychotherapy services for a member’s family may be covered as part of the treatment of the member’s WTC Health Program-covered condition. Family members include a parent, spouse, or child that lives in the same household as the member For purposes defining a “spouse,” the WTC Health Program recognizes a same-sex marriage or civil union if it is legally valid under the laws of the state or other jurisdiction, whether foreign or domestic, when and where the marriage or civil union was performed. In addition, for purposes of determining who may qualify as a family member eligible to receive the psychotherapy benefit, the WTC Health Program recognizes as a family member an individual who will attest via affidavit that s/he is in a same-sex or opposite-sex domestic partnership with a member of the WTC Health Program. This policy is consistent with a post-Windsor policy of treating same-sex marriages on the same terms as opposite-sex marriages to the greatest extent reasonably possible. .

1. Diagnostic Testing

   As part of a comprehensive mental health assessment with a qualified provider, a diagnostic interview session with other family members may be needed to assess the family context contributing to or impacted by the member’s mental health related to the September 11th attacks.

   When conducted with the explicit consent of an eligible WTC Health Program member, a single diagnostic session may be billed (CPT 90791) to the WTC Health Program as part of the member’s benefit under the Diagnostic Plan to evaluate whether the member’s situation meets the program criteria for certification. This single session may involve more than one family member, if clinically desirable. No medical services can be provided by the WTC Health Program without the consent of the WTC Health Program member.

2. Family Counseling as Treatment

   In addition, marriage or family counseling may be medically indicated to treat a WTC Health Program member’s certified mental health condition. During the course of such therapy, the non-member may require an individual therapeutic evaluation/intervention to manage traumatic reactions or trust issues emerging from the family treatment. The WTC Health Program Codebook, Vol. A identifies the appropriate codes for use when marriage or family counseling is needed to treat the member’s certified mental health condition

   The WTC Health Program may also provide a maximum of 2 family therapy sessions without the member present (CPT 90846) every 3 months for up to 8 sessions total with the express consent of the member for this specific reason. Use of the member’s treatment plan benefit for this purpose must be documented as medically necessary in the treatment record, and Level 2 PA by the CCE/NPN Clinical Director is required. The CMS-1500 form (or EDI equivalent) should be completed using the member’s ID number, the member’s name as the “Insured’s Name” (box 4) and the member’s name as the “Patient’s Name” (box 2). The remittance advice will reflect the member name only.

   Mental health conditions detected or emerging in the non-member during the course of family therapy, including ongoing trust issues, should be referred to community resources for treatment. The WTC Health Program does not cover the cost of such treatment.

3. Treatment Providers and Claims

   The mental health services can be delivered by a clinical psychologist (holds doctorate degree and is licensed in the state of practice), psychiatrist (licensed in the state of practice), or licensed clinical social worker (masters level, licensed in the state of practice; not allowed to bill for evaluation and management services).

   The Program will not pay for medications for family members who are not WTC Health Program members with certified WTC-related health conditions.

15. Inpatient Hospitalization

WTC Health Program members may require hospitalization in the treatment of their covered conditions. Such treatment is covered by the program, in accordance with the provisions below.

1. Basis for Hospital Admission and Authorization

   Only claims that relate to certified WTC-related or medically associated conditions should be submitted to the WTC Health Program.

   All inpatient hospitalizations require a Level 2 PA by the CCE/NPN Clinical Director, unless Level 3 PA by the WTC Health Program Medical Benefits Manager is required (e.g., transplants, some surgeries). See section 11 above for further information regarding PA requirements.

   The CCE/NPN Clinical Director may authorize admission for inpatient services when the admitting diagnosis (primary DRG) is directly related to the member’s certified WTC-related health condition, or directly related to a certified health condition medically associated with a WTC-related health condition. The CCE/NPN Clinical Director may also authorize admission for inpatient services when the admitting diagnosis is documented as consistent with program policy pertaining to diagnostic evaluation services for WTC-related conditions For example, some diagnostic procedures require use of general anesthesia, which may require inpatient service depending on the patient and situation..

   If the hospitalization also involves a procedure that requires prior authorization by the WTC Health Program Medical Benefits Manager (Level 3 PA) and the CCE/NPN is aware prior to hospitalization that a Level 3 PA procedure will be performed, then the admission must be authorized by both the CCE/NPN Clinical Director and the WTC Health Program Medical Benefits Manager, in accordance with established procedures for a level 3 PA. If the need for a level 3 PA procedure arises during the hospitalization, authorization will be handled on a case-by-case basis.

2. Claims Submission Requirements

   Claims for inpatient hospitalizations must be submitted using standard UB-04 format or electronically using the 837 5010 ANSI standard format. Hospital-based inpatient services should be billed on the UB-04 showing revenue center charges, ICD-9 diagnosis and procedure codes and the hospital's Medicare number. Inaccurate coding may cause inappropriate reimbursement, erroneous reductions in allowable amounts and/or delays in bill processing. The physician's professional services should be coded and billed on Form CMS-1500 or electronic equivalent.

   Discharge summaries must be submitted with all inpatient hospital claims.

   The CCE/NPN is responsible for ensuring that the hospital is enrolled as a provider in the WTC Health Program. See Chapter 6 of this manual for more information regarding enrolling providers.

   All inpatient hospital claims processed by the WTC Health Program will be priced using DRG-based pricing, as modified by the FECA Program. The amount paid will be the lesser of the DRG-based price or the amount billed. See Chapter 5 for more information regarding billing of claims.

16. Surgery

Diagnostic and reparative surgery and any surgery requiring inpatient hospitalization are generally subject to a Level 2 PA by the CCE or NPN Clinical Director in accordance with medical protocol and program policy. Transplants and certain dental surgeries or procedures related to cancer treatment require a Level 3 PA. The WTC Health Program Codebook, Vol. A should be consulted to determine whether a PA is required for any particular surgery.

17. Multiple Surgeries

Special circumstances must be considered when a member has multiple surgical procedures.

1. Multiple Surgeries Defined

   Multiple surgeries are separate procedures performed by a physician on the same patient during the same operative session or on the same day. Multiple surgeries are distinguished from procedures that are components of, or incidental to, a primary procedure. Intraoperative services, incidental surgeries or components of surgeries will not be separately reimbursed.

2. Claims Submission and Processing for Multiple Surgeries

   All multiple surgeries on a single claim are reimbursed by paying 100 percent of the fee schedule amount for the procedure with the highest cost (highest fee schedule amount) and 50 percent for all remaining procedures. In addition, the claims processing system checks for multiple surgeries across multiple claims. The claims processing system applies the 50 percent reduction to surgeries on subsequent claims for the same member on the same day by the same provider The procedures became effective on August 20, 2012.

   When submitting a claim for multiple surgeries, the most costly procedure (the one that will result in the highest fee schedule amount) should be listed first. Each additional procedure should be billed using “51” as a modifier. Payable amounts for multiple surgeries will be determined by paying the full FECA fee schedule amount for the most costly procedure, plus 50 percent of the FECA fee schedule amount for each additional procedure. Payment will be made at 50 percent for additional procedures whether or not modifier 51 is used.

3. Bilateral Procedures

   This policy does not apply to bilateral procedures. Bilateral procedures should be billed using modifier “50” and with one (1) unit, and are reimbursed at 150 percent of the FECA fee schedule amount (to account for the dual procedure).

4. Endoscopic Procedures

   The WTC Health Program does not use a special pricing algorithm for endoscopic procedures. Multiple endoscopic procedures will be priced according to the same formula as other multiple surgeries.

18. Emergency Room Treatment

Treatment in an emergency facility requires special consideration for WTC Health Program members.

1. Applicability of the Emergency Medical Treatment and Labor Act (EMTALA)

   Pursuant to EMTALA, when an individual comes to an emergency department (ED) and requests examination or treatment for a medical condition, or has such a request made on his or her behalf, the hospital must provide for an appropriate medical screening examination to determine whether or not an emergency medical condition exists (42 U.S.C. § 1395dd; 42 C.F.R. § 489.24). The WTC Health Program uses the same standard as applied under EMTALA to define an emergency medical condition This means that a medical condition is manifesting itself by acute symptoms of sufficient severity such that the absence of immediate medical attention could be reasonably expected to result in placing the health of the individual in serious jeopardy, serious impairment to bodily functions, or serious dysfunction of any bodily organ or part. (42 U.S.C. § 1395dd(e)(1)(A); 42 C.F.R. § 489.24(b)) and whether stabilization has occurred (42 U.S.C. § 1395dd(e)(3)(A)-(B); 42 C.F.R. § 489.24(b)).

2. CCE/NPN Authorization of Emergency Care

   If the CCE/NPN authorizes the patient’s emergency medical care, the WTC Health Program may cover services consistent with what is covered by EMTALA: medical screening and stabilization of presenting symptoms (42 U.S.C. § 1395dd(a), (b)(1); 42 C.F.R. § 489.24(a)(1)). When the WTC Health Program member notifies his/her CCE/NPN of the emergency department/room (ED or ER) visit, the CCE/NPN is responsible for determining if either:

   1. The presenting symptoms for which the patient appears at the ED are reasonably related to a certified condition; or
   2. The presenting symptoms can be reasonably assumed to be related to the member’s 9/11 exposure history as documented in his/her medical files. This means that the symptoms are being assessed as either the initial or emergency presentation of a condition that will qualify for certification as a WTC-related health condition.

   CCE/NPN authorization of a member seeking emergency medical care is known as Emergency Room Authorization (ER-A). The ER-A is considered to be an “authorization pending review;” this is a preliminary authorization which will be finalized upon review of the claim by the Program.

3. Claims Submission and Processing

   As with other external provider bills, ER claims must be submitted through the member’s CCE/NPN, when notified to do so by the member. The CCE/NPN is responsible for ensuring that the medical facility providing emergency services is enrolled as a provider in the Program.

   Claims submitted directly to the Program by external providers will be returned to the CCE/NPN for review and authorization. When the ER claim is submitted to the WTC Health Program via the CCE/NPN, the standard review stamp or submission through EDI represents the CCE’s acknowledgement that the CCE/NPN has an ER-A on file. As with other CCE/NPN documentation, ER-As are subject to audit and utilization reviews.

   ER claims must be accompanied by any available medical reports to facilitate the medical review.

   Whenever possible, ER claims should contain valid codes found in the WTC Health Program Codebook for the date of service. If after medical review the Program finds that codes other than those found in the Codebook are acceptable for the claim, the additional charges will be paid and the Codebook updated, accordingly. All coding and reimbursement is subject to change, update or other requirements of coding rules and guidelines.

   All ER treatment will be evaluated during the processing of the claim to ensure that treatment beyond screening and stabilization was directly related to a certified WTC-related health condition or to an initial or emergency presentation of a condition that is likely to be certified as a WTC-related health condition (based on the exposure history on file). Payment for treatment beyond screening and stabilization that is not related to a certified WTC-related health condition or a WTC exposure will be denied.

4. Hospital Registration Procedures

   The hospital providing emergency services may follow reasonable registration procedures once the patient has been screened and stabilized. EMTALA does not prohibit an inquiry into availability of medical insurance, but it does provide that neither examination nor treatment may be delayed to make the inquiry (42 U.S.C. § 1395dd(h); 42 C.F.R. § 489.24(d)(4)). A pre-authorization requirement imposed by WTC Health Program should not prevent or delay the performance of a medical screening evaluation or the institution of necessary stabilizing treatment once it is determined that an emergency medical condition exists. Hospitals may ask patients to complete financial responsibility forms upon registration. Such forms are common practice and are standard consent forms that are signed at the time of hospital registration. These forms may result in the patient being responsible for payment for services not covered by WTC Health Program.

5. Use of Emergency Facilities for Routine Care Prohibited

   An ER or ED is not the appropriate medical environment for a WTC Health Program member to seek care for a routine illness. Where the member’s medical condition never was, or never appeared to be, an emergency, a physician’s office or CCE/NPN clinic, for example, would be a more appropriate and adequate medical environment for providing such non-emergency care. Non-emergency visits to the ER or ED compromise the coordination and continuity of care for individual WTC Health Program members; therefore, they are not covered by the Program. Members should be referred back to their CCE/NPN for appropriate follow-up care. To ensure proper receipt and payment of claims, the member should inform the treating hospital/ED that the CCE/NPN should be notified of the member’s visit to the ER or ED.

19. Durable Medical Equipment (DME) and Supplies

Durable medical equipment (DME) rental or purchase is a covered health service by the WTC Health Program. The CCE or NPN Clinical Director must provide a Level 2 Prior Authorization (PA) and the DME must be ordered via prescription Only the WTC Health Program-affiliated physician may complete the prescription; the prescription must contain all of the following seven elements: Beneficiary’s name;
Description of item that is ordered;
Date of completion of the face-to-face examination;
Pertinent diagnoses/conditions that relate to the need;
Length of need;
Physician’s signature; and
Date of physician’s signature.
by a WTC Health Program-affiliated physician to treat a certified WTC-related health condition or a certified health condition medically associated with a WTC-related health condition.

1. Requirements for DME Coverage

   DME is a covered health service when the member is under the care of a CCE/NPN-affiliated physician, the DME is ordered by the physician via prescription and the CCE/NPN Clinical Director provides a Level 2 PA, and the DME is to be used primarily at home to treat a certified WTC-related health condition or a certified health condition medically associated with a WTC-related health condition.

   Suppliers of DME must be enrolled in Medicare and have a Medicare supplier number. The WTC Health Program will not pay a claim for equipment that is provided by a supplier that does not have a Medicare supplier number.

   The following three (3) requirements must be met and documented by the CCE/NPN in order for the WTC Health Program to provide payment for the service Although an item may be classified as DME, it may not be covered in every instance. Coverage in a particular case is subject to the requirement that the equipment be necessary and reasonable for treatment of an illness or injury. These considerations will bar payment for equipment which cannot reasonably be expected to perform a therapeutic function in an individual case or will permit only partial therapeutic function in an individual case. :

   1. The equipment meets the Medicare definition of DME See 42 C.F.R. § 414.202.
   2. The equipment is necessary and reasonable for the treatment of the member’s illness or injury.
   3. The equipment is used in the member’s home.

   The DME prescribed must also comply with the following requirements:

   • Can withstand repeated use;
   • Has an expected life of at least 3 years;
   • Is primarily and customarily used to serve a medical purpose related to a certified WTC-related health condition or a health condition medically associated with a WTC-related health condition;
   • Generally is not useful to an individual in the absence of an illness or injury;
   • Is appropriate for use, and is primarily used, within the home; and
   • Is not otherwise excluded.
2. Repair and Maintenance of DME

   Payment may also be made for repair, maintenance, replacement, and delivery of medically required DME and for expendable and non-reusable items essential to the effective use of the equipment. However, payments for repair and maintenance will not include payment for parts and labor covered under a manufacturer’s or supplier’s warranty.

3. Special Requirements for Power Mobility Devices

   Power wheelchairs and Power Operated Vehicles (POVs)–also known as scooters–are collectively classified as Power Mobility Devices (PMDs). PMDs are defined by CMS as a covered DME item that a patient uses in the home. In order for the WTC Health Program to cover the cost of a PMD, the patient must meet all of the following three basic coverage criteria See CMS Fact Sheet, “Power Mobility Devices (PMDs): Complying with Documentation & Coverage Requirements,” ICN 905063, January2013. Available here .:

   1. The member has a mobility limitation that significantly impairs his or her ability to participate in one or more Mobility-Related Activities of Daily Living (MRADLs) such as toileting, feeding, dressing, grooming, and bathing in customary locations in the home See 42 C.F.R. § 410.38(c).;
   2. The member’s mobility limitation A mobility limitation is one that: (a) prevents the member from accomplishing an MRADL entirely or within a reasonable time frame; or (b) places the member at reasonably determined heightened risk of morbidity or mortality secondary to the attempts to perform an MRADL. cannot be resolved sufficiently and safely by using an appropriately-fitted cane or walker; and
   3. The member does not have sufficient upper extremity function Limitations of strength, endurance, range of motion, or coordination; presence of pain; or deformity or absence of one or both upper extremities are relevant to the assessment of upper extremity function. to self-propel an optimally configured manual wheelchair An optimally configured manual wheelchair is one with an appropriate wheelbase, device weight, seating options, and other appropriate non-powered accessories. in the home to perform MRADLs during a typical day.
4. Other Equipment Used for Therapeutic Purpose

   Specified items of equipment may be covered under certain conditions even though they do not meet the definition of DME because they are not primarily and customarily used to serve a medical purpose and/or are generally useful in the absence of a WTC Health Program covered illness or injury. Such items would be covered when it is clearly established that they serve a therapeutic purpose in an individual case; such items would include:

   • Gel pads and pressure and water mattresses (which generally serve a preventive purpose) when prescribed for a patient who had bed sores or there is medical evidence indicating that they are highly susceptible to such ulceration; and
   • Heat lamps for a medical rather than a soothing or cosmetic purpose, e.g., where the need for heat therapy has been established The above items represent special exceptions and no extension of coverage to other items should be inferred..

   In establishing medical necessity for the above items, the evidence must show that the item is included in the physician’s course of treatment and a physician is supervising its use.

5. Devices and Equipment Not Considered DME

   Equipment which is primarily and customarily used for a nonmedical purpose may not be considered “medical” equipment for which payment can be made under the WTC Health Program. This is true even though the item has some remote medically-related use. For example, in the case of a cardiac patient, an air conditioner might possibly be used to lower room temperature to reduce fluid loss in the patient and to restore an environment conducive to maintenance of the proper fluid balance. Nevertheless, because the primary and customary use of an air conditioner is a non-medical one, the air conditioner may not be deemed to be DME for which payment can be made See Medicare Benefit Policy Manual, Chapter 15, § 110.1 (Rev. 161, Oct. 26, 2012). .

   Other devices and equipment used for environmental control or to enhance the environmental setting in which the beneficiary is placed are not considered covered DME. These include, for example, room heaters, humidifiers, dehumidifiers, and electric air cleaners. Equipment which basically serves comfort or convenience functions or is primarily for the convenience of a person caring for the patient, such as elevators, stairway elevators, and posture chairs, do not constitute DME. Similarly, physical fitness equipment (such as an exercycle), first-aid or precautionary-type equipment (such as preset portable oxygen units), self-help devices (such as safety grab bars), and training equipment (such as Braille training texts) are considered nonmedical in nature.

   The following DME are excluded from coverage under the WTC Health Program:

   • DME for a member who is a patient in a type of facility that ordinarily provides the same type of DME to its patients at no additional charge in the usual course of providing its services is excluded.
   • DME with deluxe, luxury, or immaterial features which increase the cost of the item to the WTC Health Program relative to a similar item without those features.
6. Claims Submission and Processing

   The CCE/NPN Clinical Director must provide a Level 2 PA. The CCE/NPN is responsible for ensuring that the DME supplier is enrolled in the WTC Health Program. The WTC Health Program will pay for a member to receive DME if all established conditions are met.

   Reimbursement rates for DME are in accordance with the FECA fee schedule.

   Payment for DME is either on a rental or lump-sum purchase basis. In the case of rental, the item(s) are to be paid monthly The rental is not to exceed a period of continuous use of 15 months or, on a purchase option basis, is not to exceed a period of continuous use of 13 months. For the first three rental months, the rental fee schedule is calculated so as to limit the monthly rental to 10% of the average of allowed purchase prices on claims for new equipment during a base period, updated to account for inflation. For each of the remaining months, the monthly rental is limited to 7.5% of the average allowed purchase price. After paying the rental fee schedule amount for 15 months, no further payment may be made except for payment for maintenance and servicing. See Medicare Claims Processing Manual, Chapter 20, Section 30. Separate maintenance and servicing payments are not made for any rented DME, nor are delivery and service charges for rental or purchased DME. Such costs are assumed to have been taken into account by suppliers (along with all other overhead expenses) in setting the prices they charge for covered items and services.

   The Program will continue to review available DME codes and add them to the Codebook, as appropriate. DME items prescribed and considered to be medically necessary for treatment of a member’s certified condition(s), may be requested for addition to the Codebook by the CCE/NPN through the usual change request process.

20. Physical Therapy, Occupational Therapy

Reserved.

21. Home Health Care

Home Health Care services are personal care and related support services that enable WTC Health Program members to live at home while receiving medically necessary care for a condition or conditions certified by the WTC Program Administrator. Under certain circumstances, care received at home may be a substitute for receiving medically necessary care in a hospital or skilled nursing facility for members who are homebound The WTC Health Program has consulted Medicare and TRICARE® guidelines in developing this policy to ensure consistency of the benefit in establishing the conditions to be met and services to be provided..

1. Homebound Defined

   The WTC Program Administrator has elected to follow the definition of “confined to his home” used by CMS to determine whether a WTC Health Program member is “homebound.” In establishing conditions required for payment of services, CMS defines an individual as being “confined to his home” when:

   the individual has a condition, due to an illness or injury, that restricts the ability of the individual to leave his or her home except with the assistance of another individual or the aid of a supportive device (such as crutches, a cane, a wheelchair, or a walker), or if the individual has a condition such that leaving his or her home is medically contraindicated. While an individual does not have to be bedridden to be considered ‘‘confined to his home,” the condition of the individual should be such that there exists a normal inability to leave home and that leaving home requires a considerable and taxing effort by the individual [42 U.S.C. § 1395n(a)].

   CMS further clarifies that the individual may leave home for medical treatment or short, infrequent absences for non-medical reasons, such as attending religious services, and may still receive home health care if he/she attends adult day care. In order for a qualified service provider to be eligible for payment for home health services, CMS requires that the individual submit a written request and that an enrolled physician certify that:

   1. The services are required because the individual is confined to his home and needs skilled care on an intermittent basis;
   2. A plan for services has been established;
   3. The services are furnished while the individual is under the physician’s care; and
   4. Prior to the certification the physician, or a nurse practitioner or clinical nurse specialist under the physician’s supervision, has had an in-person encounter with the individual in the past 6 months.

   See 42 U.S.C. § 1395n(1) - (2)(A).

2. Requirements for Coverage of Home Health Care

   Home health care is intended to provide treatment for an illness or injury with the goal of maintaining health. In order for a member’s home health care to be eligible for payment by the WTC Health Program, the following requirements must be met and documented by the CCE or NPN:

   1. The member must be under the care of a physician affiliated with a CCE or the NPN.
   2. The Home Health Agencies (HHA) provider caring for the member must be Medicare-certified and enrolled in the WTC Health Program’s claims processing system See Bulletin 12-4- “New Claims Adjudication Rules for Missing/Invalid NPIs” for guidance with enrollment..
   3. The CCE or NPN network physician must provide a “plan of care” to the CCE/NPN Clinical Director for a level 2 PA for home health services Home Health Agencies (HHAs) often use a standardized data collection form (CMS Form 485 – Appendix 4-D) to document the plan of care; however, the form is not mandatory for WTC Health Program purposes as long as all required justification information is summarized under the heading of such a plan of care in the member’s medical record and available for audit as needed. Identification of the ‘primary’ HHA for each episode of care is critical for proper claims payment.. >
      1. Separate PAs Required for Each Episode of Care

         The CCE or NPN Clinical Director shall provide authorizations in 60-day episodes of care. The HHA will be required to obtain additional authorization if there is a need for subsequent episodes of care. If the member still requires home health care at the end of the initial 60-day episode of care, a new authorization will be required to justify a new episode of care on day 61. Re-authorization continues to be required (the next episode would start on day 121, the next on day 181, etc.) as long as the member is receiving services under the HHA’s plan of care. More than one episode may be authorized for the same or different dates of service when there is a transfer to another HHA, or discharge with readmission to the same HHA. Authorization for service extending beyond 120 days may be subject to audit by the WTC Health Program for medical necessity.

   4. The member requires the skilled services of at least one of the following:
      1. Part-time or intermittent skilled nursing care A member is not eligible for the home health benefit if more than part-time or intermittent skilled nursing care is needed. Part-time or “intermittent” care is defined as skilled nursing care services rendered on fewer than 7 days each week or less than 8 hours each day over a period of 21 days (or less) with some exceptions in special circumstances. Hour and day limits may be extended in special circumstances using a level 3 PA process with the WTC Health Program Medical Benefits Manager. provided by or under the supervision of a registered professional nurse. To qualify as skilled service, all of the following criteria must be met:
         1. Requires the skills of a nurse based on the inherent complexity of the service, the condition of the patient and accepted standards of medical and nursing practice;
         2. Is performed by an RN or LPN under the supervision of an RN;
         3. Is reasonable and necessary to the treatment of the patient’s illness or injury; and
         4. Is either intermittent or part-time. The patient has a medically predictable recurring need for skilled nursing services. In most instances, this definition will be met if the patient requires a skilled nursing service at least once every 60 days.
      2. Physical/occupational, or speech-language pathology services
      3. Medical social services under the direction of a physician
      4. Routine and non-routine medical supplies
      5. Part-time or intermittent services of a home health aide. In general, a member is not eligible for home health aide care including homemaker services and personal care services if these services are not related to the member’s plan of care. However, extenuating situations may be presented in a plan of care for a Level 3 PA by the WTC Health Program Medical Benefits Manager. The reason for the visits must be to provide hands-on personal care of the patient or services needed to maintain the member’s health or to facilitate treatment of the member's illness or injury. The information submitted should indicate the frequency of the home health aide services required.

22. Skilled Nursing Facility/Extended Care Coverage

Extended care services are provided to WTC Health Program members who require skilled nursing or rehabilitation staff to manage, observe, and evaluate their care for a condition or conditions certified by the WTC Program Administrator. Inpatient skilled nursing facility (SNF) care, including room and board, skilled nursing care, and other customarily provided services in a Medicare-certified skilled nursing facility, are covered when certain factors are met The WTC Health Program has consulted Medicare and TRICARE guidelines in developing this policy to ensure consistency of the benefit in establishing the conditions to be met and services to be provided.. The WTC Program Administrator has elected to follow factors similar to those used by CMS See generally CMS regulations at 42 C.F.R. § 409.31..

1. Requirements for Coverage of SNF/Extended Care Coverage
   1. Member Need for SNF or Extended Care

      All of the following conditions must be established and documented by the CCE/NPN in order for the WTC Health Program to provide payment for services As described in WTC Health Program Bulletin 12-24, Procedures for Prior Authorization of Medical Services, the CCE/NPN director must include documentation in the member’s medical record that captures the rationale supporting the medical necessity of the service and relatedness of the service to the conditions covered by the Program. This documentation is subject to audit, and the Program will perform utilization reviews.:

      1. The member requires daily skilled nursing services or skilled rehabilitation services that must be performed by or under the supervision of professional or technical personnel In determining whether the daily skilled care needed by an individual can only be provided in a SNF on an inpatient basis, the CCE or NPN should consider the member’s physical condition and the availability and feasibility of using more economical alternative facilities or services.;
      2. As a practical matter, considering economy and efficiency, the daily skilled services can only be provided on an inpatient basis in a SNF Daily skilled services can only be provided in a SNF if they are not available on an outpatient basis in the area the member resides or transportation to the closest facility would be: an excessive physical hardship; less economical; or less efficient or effective than an inpatient institutional setting. The feasibility of obtaining assistance for the member at home should also be considered. ; and
      3. The services must be reasonable and necessary for the treatment of a member’s illness or injury (i.e., consistent with the nature and severity of the member’s illness or injury, the member’s particular medical needs, and accepted standards of medical practice). The service must also be reasonable in terms of duration and quality See Medicare Benefit Policy Manual, Chapter 8, Section 30.2 (Rev. 161, Oct. 26, 2012)..

      If any one of these factors is not met, a stay in a SNF, even though it might include the delivery of some skilled services, is not covered by the WTC Health Program.

   2. Additional Requirements CCE/NPN Must Establish in Order for the SNF to Qualify as a Provider
      1. The SNF caring for the member must be Medicare-certified, and the CCE/NPN is responsible for ensuring that the SNF admitting the member is enrolled as a provider in the WTC Health Program.
      2. The CCE or NPN must also confirm that the SNF meets both of the following basic requirements:
         1. The SNF must be primarily engaged in providing either:
            • Skilled nursing care and related services for members who require medical or nursing care; or
            • Skilled rehabilitation services for the rehabilitation of injured, disabled, or sick persons and is not primarily for the care and treatment of mental diseases.
         2. Skilled services must be rendered under physician orders, require the skills of qualified technical or professional health personnel such as RNs, LPNs, and/or therapists (physical, occupational, speech–language pathologists or audiologists), and must be provided directly by or under the supervision of these skilled nursing or skilled rehabilitation personnel.
      3. In order for a member’s SNF care to be eligible for payment by the WTC Health Program, the CCE or NPN must meet and document each of the following requirements:
         1. The member must be under the care of a physician affiliated with a CCE or the NPN
         2. The CCE or NPN network physician must provide a “plan of care” to the CCE/NPN Clinical Director for a level 2 PA for SNF SNF services The required justification information shall be summarized under the heading of such a plan of care in the member’s medical record and available for audit as needed. The care plan should address and include the following, as available:
            1. Discharge summary from the acute care stay;
            2. Admission history and physical from hospital;
            3. Doctors' orders and progress notes (last 4 weeks);
            4. Nurses' notes - daily narrative, not weekly summaries (last 4 weeks);
            5. Most current Minimum Data Set (MDS) assessment;
            6. Physical, occupational, speech and respiratory therapy evaluations, logs and progress notes; and
            7. Wound care notes (measurement, treatment, where acquired).
            .
            • The CCE/NPN Clinical Director shall provide an initial level 2 PA for a 30-day SNF episode of care. The SNF will be required to obtain additional authorization(s) if there is need for subsequent episodes of care (in 30-day increments). Level 2 PA continues to be required (in 30 day increments) as long as the member is receiving SNF services.
2. Post-Hospital Extended Care Services

   Extended care services are considered post-hospital if initiated within 30 days following discharge. In order to be eligible for coverage of post-hospital extended care services, the member must be receiving inpatient hospital care for a WTC Health Program certified condition for not less than 3 consecutive days of medically necessary services before discharge, and must also require a skilled level of care.

   The member must also require at least one of the following See 42 C.F.R. § 409.20.:

   1. Nursing care provided by or under the supervision of a registered professional nurse;
   2. Physical therapy, occupational therapy, and/or speech-language pathology services;
   3. Medical social services;
   4. Drugs, biologicals, supplies, appliances, and equipment;
   5. Services furnished by a hospital with which the SNF has a transfer agreement in effect Under 42 C.F.R. § 483.75(n).; or
   6. Other services that are generally provided by (or under arrangements made by) SNFs.
3. Exclusions from SNF Benefit

   The following are excluded from the SNF benefit:

   1. The WTC Health Program will not pay for the services of a private duty nurse or attendant See 42 C.F.R. § 409.12(b).. An individual is not considered to be a private duty nurse or attendant if he or she is a SNF employee at the time the services are furnished.
   2. Private accommodations, except in circumstances where See 42 C.F.R. § 409.11.:
      1. The patient’s condition requires isolation;
      2. The SNF has no semiprivate or ward accommodations; or
      3. The SNF semiprivate and ward accommodations are fully occupied by other patients, or were so occupied at the time the patient was admitted to the SNF for treatment of a condition that required immediate inpatient SNF care, and have been so occupied during the interval.
   3. Personal convenience items such as television, radio, or telephone in the room See Medicare Benefit Policy Manual, Chapter 16, Section 80 (Rev. 122, April 9, 2010); or
   4. Custodial Care See Medicare Benefit Policy Manual, Chapter 8, Section 50 (Rev. 161, Oct. 26, 2012).

23. Immunization

1. Vaccine Coverage Generally

   Influenza and pneumococcal vaccines are payable under the Program for all members who are enrolled in monitoring, screening, diagnostic and treatment programs, except for FDNY family members. The WTC Health Program will cover the procedure to administer the vaccine and the vaccine product. Coding guidance may be found in the WTC Health Program Codebook. These vaccines are covered under the program according to the vaccine administration guidelines recommended and published by CDC. Please refer to CDC guidelines for the clinical guidance, which can be found on the following websites:

   • Influenza: https://www.cdc.gov/flu/professionals/vaccination/vax-summary.htm
   • Pneumococcal: https://www.cdc.gov/vaccines/pubs/ACIP-list.htm#pcv and https://www.cdc.gov/vaccines/pubs/acip-list-sup/acip-sup-pneumo.htm

     In addition, because both herpes zoster (shingles) and pertussis (whooping cough) can impact the respiratory system and can cause severe debilitation in an already debilitated host, the Program covers the administration of pertussis and herpes zoster vaccines for members who are at risk of contracting these infections due to compromised immunity stemming from a certified WTC-related or medically associated health condition.

2. Herpes Zoster (Shingles) Immunization

   The WTC Health Program covers administration of the shingles vaccine (Zostavax®), as recommended by the CDC Advisory Committee on Immunization Practices (ACIP). ACIP recommends a single dose of zoster (shingles) vaccine for adults 60 years old or older, whether or not the patient reported a prior episode of shingles. In addition, persons with chronic medical conditions may be vaccinated unless a contraindication or precaution exists for their condition. WTC Health Program members with compromised or suppressed immune systems who have an increased risk for herpes zoster (shingles) include those with cancer, especially leukemia and lymphoma, and those taking immunosuppressive medications including steroids, chemotherapy, or transplant-related immunosuppressive medications.

3. Pertussis (Whooping Cough)

   WTC Health Program members with respiratory conditions can experience significant adverse effects from pertussis (whooping cough) Pertussis-related coughing fits can lead to difficulty breathing, vomiting and disturbing sleep. A cough can last for up to 10 weeks. Complications can be severe, and approximately 5 percent of adults with pertussis are hospitalized.. Vaccination is the most effective way to prevent pertussis, and Tdap is the recommended vaccine for adults Protection from the childhood vaccine fades over time and health officials now recommend adults and adolescents receive a Tdap booster vaccine to protect against whooping cough. It is especially important for those in contact with infants younger than 12 months of age. The Tdap booster is recommended instead of the previously recommended Td (tetanus-diphtheria) booster. and teens.

4. Covered Vaccines

   Zostavax and Tdap vaccines may be administered to those WTC Health Program members who are at risk for such infections and are certified for one of the following WTC-related conditions:

   1. Systemic cancer,
   2. Lower airway disease (obstructive airway and restrictive lung disease), or
   3. Lung transplant due to a WTC-related lung disease.

24. Smoking Cessation Program 42 See WTCHP Bulletin 13-20, “Smoking Cessation Therapy” (updated Sept. 2014), for additional guidance.

The WTC Health Program provides smoking cessation therapy only for those member’s with specific certified WTC-related health conditions (certain aerodigestive disorders, mental health conditions, or cancer types) or eligible members who are current smokers and are referred as part of the lung cancer screening program. For members with one of the specific certified WTC-related health conditions, smoking cessation therapy will be added to the care suite for the certified condition and the available pharmaceutical formulary will include medications for use in conjunction with smoking cessation therapy. For those members who are eligible though a referral from the lung cancer screening program, the benefit will accessible through the diagnostic care suite. When a member is referred for these services, the information is entered into the member’s medical record and the appropriate care suite is assigned to allow for that coverage. Records regarding members referred for smoking cessation therapy are available for audit as needed.

25. Pharmacy Benefits

The WTC Health Program assigns each member to the appropriate Pharmacy Benefit Plan(s) based on individual member records on file. Each member record contains categories of health conditions that have been certified and indicate the member’s status (i.e., responder, screening-eligible survivor, certified-eligible survivor, surviving immediate family member of one of the FDNY responders who were killed at the WTC site on 9/11/2001). The table located in Section 4G, of this chapter summarizes the current Pharmacy Benefit Plans and provides highlights regarding plan eligibility criteria, indicators of formulary content, and plan use limitations. For additional information on pharmacy benefits, see Chapter 14, Pharmacy Benefits.

26. Controlled Substances

All controlled substances require Level 2 PA by the CCE/NPN Clinical Director or designee. PAs for formulary items are communicated via the PBM’s electronic authorization portal. Controlled substances administered in the office and billed through HCPCS codes must have a Level 2 PA using the process described in paragraph 11 above.

27. Hospice Care

Hospice provides medical, psychological, and spiritual support during end-of-life care. Hospice care Hospice care focuses on controlling pain and other symptoms of illness so members can remain as comfortable as possible near the end of life. The hospice team includes doctors, nurses, home health aides, social workers, clergy or other counselors, and trained volunteers. The team may also include speech, physical, and occupational therapists, if needed. The hospice team will work with the member on the member’s goals for end-of-life care. Hospice services may include doctor or nursing care, medical supplies and equipment, home health aide services, short-term respite (relief) services for caregivers, drugs to help manage cancer-related symptoms, spiritual support and counseling, and social work services. Members’ families are also an important focus of hospice care, and services are designed to give them assistance and support allows the member to remain at home in a personal, comfortable setting, or in special in-patient facilities, hospitals, or nursing homes. It also supports caregivers and families with bereavement counseling. The WTC Health Program will pay for hospice services when therapies for a covered condition are no longer controlling the illness and, if the illness runs its normal course, the member’s life expectancy is 6 months of less If the member lives longer than 6 months, hospice care can continue, as long as the CCE or NPN Clinical Director reconfirms that the member is terminally ill. . If the patient’s condition improves or the illness goes into remission, hospice care can be discontinued and active treatment may resume The member may return to hospice care at any time (as long as the CCE/NPN Clinical Director reconfirms the member’s terminal illness and prepares a Level 2 Prior Authorization)..

1. Requirements for Coverage of Hospice Care

   Acceptance into hospice care requires a Level 2 Prior Authorization by the CCE or NPN Clinical Director specifying that the member has a life expectancy of 6 months or less if the disease runs its normal course. The member also signs a statement saying that he or she is choosing hospice care. (Hospice care can be continued if the patient lives longer than 6 months, as long as the CCE or NPN Clinical Director reconfirms the patient’s condition.)

   In order for a member’s hospice care to be eligible for payment by the WTC Health Program, the CCE/NPN must meet and document the following requirements:

   1. The member must be under the care of a CCE/NPN-affiliated physician. The care must be provided from a Medicare-approved hospice program and the CCE/NPN is responsible for ensuring that the hospice program is enrolled as a provider in the WTC Health Program.
   2. The CCE/NPN network physician must provide a Plan of Care The required justification information shall be summarized under the heading of such a Plan of Care in the member’s medical record and available for audit as needed. It should verify that the need for hospice care arises from the member’s certified WTC-related health condition and include the Clinical Director’s judgment that the member has a life expectancy of 6 months or less if the disease runs its normal course, and must reflect the member’s individual clinical circumstances. The justification should be individualized and cannot contain check boxes or standard language that is used for all members. to the CCE or NPN Clinical Director for a Level 2 Prior Authorization for hospice care, which is given in benefit periods.
   3. The CCE or NPN Clinical Director shall initially provide a Level 2 Prior Authorization for a 90-day benefit period. Additional authorization Level 2 Prior Authorization continues to be required (in 60-day increments) as long as the member is receiving hospice services. At the start of each benefit period, the CCE or NPN Clinical Director must reconfirm that the member is terminally ill, to continue to receive hospice care. A benefit period starts the day the member begins receiving hospice care and it ends when the 90-day or 60-day period ends, unless a new Level 2 Prior Authorization for hospice care is prepared. are required if there is a need for subsequent hospice care (in 60-day increments).
2. Covered Services
   1. The following hospice services can be provided when they’re needed to care for a member’s terminal illness and related condition(s):
      • Physician services
      • Nursing care
      • Medical equipment (such as wheelchairs or walkers)
      • Medical supplies (such as bandages and catheters)
      • Drugs for symptom control or pain relief
      • Hospice aide and homemaker services
      • Physical and occupational therapy
      • Speech-language pathology services
      • Social worker services
      • Dietary counseling
      • Grief and loss counseling for member and family
      • Short-term inpatient care (for pain and symptom management)
      • Short-term respite care
      • Other services needed to manage pain and other symptoms related to the member’s terminal illness, as recommended by the hospice
   2. If receiving at-home hospice care, a member may receive inpatient respite care in a Medicare-approved facility (such as a hospice inpatient facility, hospital, or nursing home) if their usual caregiver (such as a family member) needs a rest. Members can stay up to 5 days each time they receive respite care; the member may be provided respite care more than once, but only on an occasional basis.

28. Medically Necessary Dental Care

The World Trade Center (WTC) Health Program will authorize medically necessary dental care in limited circumstances for members with certain certified WTC-related health conditions. Medically necessary treatment means the provision of services by physicians and other health care providers, diagnostic and laboratory tests, prescription drugs, inpatient and outpatient hospital services, and other care that is appropriate to manage, ameliorate or cure a WTC-related health condition or a health condition medically associated with a WTC-related health condition, and which conforms to medical treatment protocols developed by the Data Centers and approved by the WTC Program Administrator. 42 C.F.R. § 88.1.

The WTC Health Program currently authorizes medically necessary dental care for members with certified WTC-related head and neck cancers. Dental care which is routine, preventive, restorative, prosthodontic, periodontic, or emergency will not generally qualify as medically necessary care. Targeted medically necessary dental care may be authorized in two situations: (1) where the dental care is adjunctive and required in preparation for treatment of certain certified WTC-related head and neck cancers; or (2) where the dental care is intended to address dental trauma or adverse effects resulting from treatment of certified WTC-related head and neck cancers and the dental condition is certified as medically associated with the WTC-related head or neck cancer. Such medically necessary dental care is limited to targeted care necessary in preparation for treatment of the certified WTC-health condition or to address dental concerns resulting from treatment. The WTC Health Program will authorize medically necessary dental care treatment in members with certified WTC-related head and neck cancers through prior authorization requests. Medically necessary dental care related to other certified WTC-related health conditions may be considered on a case-by-case basis, in accordance with the requirements established by this policy.

Level 2 Prior Authorization (Level 2 PA): CCE/NPN Request for Initial Dental Evaluations

The medical necessity of an initial dental evaluation for a member with a certified WTC-related head or neck cancer must be supported through a Level 2 Prior Authorization by the CCE/NPN Clinical Director, documented in the patient’s medical record. Authorizations are limited to the procedures specified in the WTC Health Program Codebook under Level 2 PA.

Level 3 Prior Authorization (Level 3 PA): CCE/NPN Request for Follow-up or Further Dental Evaluation and Treatment

Follow up evaluation or medically necessary treatment identified during the initial dental evaluation require prior authorization by the WTC Health Program (Level 3 PA). Authorization must be requested from WTC Health Program by the CCE/NPN Director. The following must be documented in the authorization request:

• Completed Level 3 Dental PA request form (Appendix 4-E “Dental Prior Authorization Level 3 Request Form) including documentation of medical necessity (including how the dental care/service(s) relates to the management of the relevant certified WTC-related cancer and/or medically associated condition(s) and whether care is adjunctive or corrective) and a finalized up-to-date dental treatment plan.
• Supporting materials/documentation required for payment authorization, as detailed in the WTC Health Program Codebook.

To the extent that neither FECA nor Medicare have established rates for such dental services, the WTC Health Program will reimburse medically necessary dental care (Prior Authorization Level 2 and 3 dental codes) based upon the American Dental Association (ADA) Survey of Dental Fees, 85th percentile fee schedule.

Denial of Authorization for Dental Treatment

WTC Health Program denials of requests for authorization of dental care are subject to appeal by the member (See Chapter 3, Section 10). Appeal rights will be provided when the outcome of the Program evaluation is a denial decision (see Chapter 3 for additional information on appeals). Level 2 PA dental care denials are subject to secondary review.

Appendices

4-A WTC Health Program Instructions for Completing WTC-3 Package Requesting Certification for Types of Cancer

4-B Medical Change Review Request Form

4-C Transplant Authorization Form

4-D Home Health Care CMS Form 485

4-E Dental Prior Authorization Level 3 Request Form

4-F Policy and Procedures for Cancer Screening

Chapter 5 - Claims Processing and Billing

1. Purpose and Scope

This Chapter provides a high level overview of the process for submitting and processing claims for medical benefits under the WTC Health Program. This process is managed by the Health Program Support (HPS) contractor. A more complete description of the claims processing function is found in the WTC Health Program Claims Processing Procedure Manual, found in the WTC Health Program file of record.

2. Statutory and Regulatory References

The sections of the Public Health Service (PHS) Act applicable to this Chapter include Section 3312(c), Payment for Initial Health Evaluation, Monitoring, and Treatment of WTC-Related Health Conditions, and Section 3331, Payment of Claims. The sections of the WTC Health Program regulations applicable to this Chapter include 42 C.F.R. §§ 88.20, 88.22, 88.23.

3. Responsibilities

The parties involved in developing, submitting, processing, and paying claims are described below.

1. A. The Clinical Centers of Excellence (CCEs) and Nationwide Provider Network (NPN) develop and submit claims for medical benefits to the WTC Health Program HPS contractor and ensure that they are submitted in accordance with established requirements and guidelines, described further in Chapter 4. The CCEs/NPN provide and make referrals to affiliated external medical providers to provide treatment, monitoring, and screening services. They authorize medical treatment, monitoring, and screening services. Additionally, they provide information to the HPS contractor to enable it to enroll external medical providers in the WTC Health Program, and validate the professional qualifications of those providers. Some of the CCE/NPN functions may be performed by a third party administrator (TPA), if engaged by the CCEs/NPN.
2. The HPS contractor receives and processes claims for medical benefits, resolves claims that pend due to system edits (for example, when a claim requires review by the Medical Benefits Manager (MBM) or requires follow up for missing information), prices claims, generates the data used to make payments to medical providers, submits a weekly payment file to the payment contractor using a standard format, and maintains the provider file for the WTC Health Program. The HPS contractor works with the submitting CCE/NPN, when necessary, to resolve any issues preventing successful processing of the claim and works with the payment contractor to resolve any issues identified with the payment file. The HPS contractor also creates and provides special reports regarding claims outcomes to the CCEs/NPN, and notifies the CCEs/NPN of any issues encountered by the payment contractor that might impact payments.
3. The Centers for Medicare & Medicaid Services (CMS) payment contractor receives the payment file from the HPS contractor and issues payments via Electronic File Transfer (EFT) to providers. The payment contractor also issues Remittance Advices (RAs), documents that provide notice of and reasons for payment, adjustment, denial and/or uncovered charges of a claim, to the medical providers. The payment contractor then communicates payment information back to the HPS contractor, notifying the HPS contractor if there are any problems with the payment data. To ensure compliance with requirements in the Zadroga Act (Section 3306(14)(B)), the payment contractor is engaged via an inter-agency agreement with CMS.
4. The MBM reviews and takes actions on medical claims appeals and is in the process of establishing a more formal process for appeals of reimbursement denials (see section 13 of this chapter).
5. The electronic data interchange (EDI) clearing house provides a mechanism for medical claims to be transmitted electronically between CCEs/NPN and the HPS contractor.
6. The pharmacy benefits manager (PBM) receives claims from the pharmacies, applies adjudication rules according to standards developed by the WTC Health Program, and compiles and communicates payment and denial data.

4. Overview

The Program uses Plexis Healthcare System’s Quantum Choice claims processing software to manage enrollee and provider information and to process claims. The claims processing function is scaled to the relatively small size of the WTC Health Program and is designed to quickly, efficiently, and accurately process claims submitted for payment, in accordance with the provisions of the Act.

1. The various functions in the payment process are separated both physically and functionally, in accordance with industry best practices. The HPS contractor maintains separation of functions by having different teams for mail handling and imaging, enrollment, eligibility, claims processing, provider enrollment, and auditing. In this way, the risk of fraud is minimized, since no one individual/team can both submit and approve or pay a claim.
2. Medical monitoring and treatment claims are submitted to the HPS contractor either by or through the CCEs/NPN or subcontractors such as a TPA, working on behalf of the CCEs/NPN.
3. Claims are submitted in a variety of ways, depending on the CCEs’ preferences and technical infrastructure. They are accepted when submitted using one of the following methods: (1) on paper using the appropriate forms (i.e., CMS-1500 or UB-04);, (2) on spreadsheets that have been structured to capture the data required by the CMS-1500 or UB-04 form;, or (3) electronically through EDI.
4. The CMS-1500 form (seen in Appendix 5-A) is used by out patient healthcare professionals and suppliers and the UB-04 (seen in Appendix 5-B) is used by healthcare institutions (such as hospitals, rehabilitation centers, and skilled nursing facilities). Both are standard forms developed by CMS and used regularly in other federal programs such as Medicare. The WTC Provider Manual provides guidance on how the forms are to be completed for claims under the Program.
5. Paper claims are first created or, in the case of claims coming from external providers, reviewed by the CCEs/NPN, then approved for submission. The CCEs/NPN indicate their authorization of a claim by affixing a special authorization stamp or by attaching a notice of authorization. The claims are then mailed or faxed to the HPS contactor, which scans the paper claim and uploads the images to a secure server so that the claims processing staff can access and enter the data into the claims processing system.
6. Claims submitted using structured spreadsheets are sent directly to the claims processing team by the CCE/NPN, along with its authorization, using a secure server. The claims processing team is notified of the transmission by the data management team, and processes the data in the same manner as paper claims.
7. EDI claims are sent to the HPS contractor electronically using the 837 5010 ANSI standard format, and are uploaded into the claims processing system. When a CCE submits EDI claims using the approved process, it acknowledges that the claims are authorized to be paid. EDI claims received from external providers are pended, and a report is forwarded to the providers’ associated CCEs /NPN to obtain their authorization so that the claims can be processed.
8. All claims are processed by the HPS contractor using the system configurations and processes developed for use by the Program. Data from the enrollment and certification processes are used along with other industry-standard and WTC Health Program-specific parameters to determine whether the claim is payable. Certain types of claims, such as inpatient care, emergency room visits, and cancer treatment, are reviewed by the MBM for approval before they are paid. Claims may also pend for review for other reasons, such as when additional information is needed to complete the claim. Payable claims are priced according to the fee schedule, described in section 8 below. Additional information concerning the claims process may be found in the WTC Health Program Claims Operations Manual, located in the WTC Health Program file of record.
9. The HPS contractor compiles data from the claims processing system for both approved and denied claims, which are transmitted tothe payment contractor on a weekly basis. Payments to providers are issued weekly via EFT. The payment contractoralso issues the RAs for claims. Section 10 below provides more detail.
10. Pharmacy claims are submitted electronically by the pharmacies to the PBM and are then sent to the HPS contractor weekly for further processing. After the HPS contractor forwards a payment file to the payment contractor, the payment contractor issues payments to the PBM, which then forwards the payments to the pharmacies.
11. Payment reconciliation, payment adjustments, and audits are performed by the HPS contractor, as further described in section 10 below.

5. EDI Claims

Approximately 90 percent of all claims are submitted to the HPS contractor via EDI using the 837 5010 ANSI standard format. The Program encourages use of EDI as it improves the efficiency and effectiveness of claims processing, reduces the potential for error, and speeds transaction times. CCEs/NPN, their TPAs, and approved external providers submit claims to the EDI clearing house using the 837 format. The clearing house then delivers the claims to the HPS contractor for claims processing.

6. Pharmacy

Prescriptions covered under the Program are issued in accordance with the WTC Health Program-approved pharmaceutical guidelines and the Program’s formulary. The formulary and guidelines are aligned with the Program’s pharmacy benefit plans, which are described in WTC Health Program Bulletin No. 13-2, “Implementing Pharmacy Benefit Plans by Health Condition Certification Status.” These plans, implemented to improve programmatic oversight and minimize fraud, waste and abuse, are documented in the WTC Health Program file of record.

1. Prescription drugs are approved at the point of sale (POS). Members provide their WTC Health Program coverage information to the pharmacy, which validates their enrollment through the PBM. The PBM also checks to ensure that the prescribing provider is authorized to prescribe under the Program and that the prescribed drug is covered under the WTC Health Program formulary. After filling the prescription, the pharmacy submits claims electronically to the PBM. Pharmacy claims data are accumulated on a weekly basis and transmitted by the PBM to the HPS contractor which processes the claims and sends them to the payment contractor. The payment contractor pays the PBM, which then issues payments to the pharmacies.
2. If the prescription is rejected at the POS, the rejection may be overridden, when necessary, by the CCEs/NPN or by the HPS contractor’s pharmacy team after consultation with the CCE/NPN. CCEs/NPN have access to an online program offered by the PBM which allows online adjudication of pharmacy transactions. Inquiries regarding rejected prescriptions are received via the Program’s Call Center, which either resolves the reason for the rejection (e.g., the pharmacy has an incorrect enrollee number) or routesthe issue to the Member Services team for resolution.
3. The WTC Health Program’s pharmacy network is open, and any pharmacy may submit a claim to the WTC Health Program.
4. The physicians who are permitted to prescribe under the WTC Health Program are limited to those providers who have been authorized by the CCEs. Weekly updates of permitted prescribers are sent by the CCEs to the PBM, which shares this information with the HPS contractor. If a provider is permitted to prescribe medications under the WTC Health Program, the provider’s prescriber status is recorded in the claims processing system’s Provider Module.
5. Prescription drugs may also be provided through mail-order. Mail-order is encouraged, when feasible, as it adds efficiency to the Program. The member must register and can do soat the mail-order provider’s Website online, via telephone, or through the CCE/NPN. Once the member is registered, the prescribing physician can e-prescribe, fax, or mail the prescription to the mail-order provider. Mail-order is generally used for maintenance medications only, and they are provided in a 90-day supply. Once a prescription is filled through the mail-order service, the member receives a form for refill. Refills may also be obtained online or by phone, and members may elect to auto-refill. To ensure accuracy and prevent fraud, prescribers cannot call in an initial mail-order prescription.
6. In response to concerns about significant barriers to care for members with systemic cancers that are likely to receive their care through extended care networks (affiliated with but separate from the CCE/NPN), the WTC Health Program broadly expanded the therapeutic classes available in the Cancer Treatment Pharmacy Plan, opened the prescriber network, and removed prior authorization restrictions. To assist in the alignment of certification activities justifying drug coverage or member counseling about the pharmacy benefit, the CCEs and the NPN conduct weekly retrospective drug utilization reviews for these members as part of their quality assurance activities.
7. Pharmacy claims must be submitted within 180 days of the fill date. Older claims must have prior authorization, in order to help prevent untimely filing of claims.
8. Prescription medications are available according to the pharmacy benefit plan to which the member is assigned. Medications that are covered under the WTC Health Programare listed in the formulary (Part C of the WTC Health Program Codebook).

7. Fee Schedule

1. The Zadroga Act requires that the payment rate for an initial health evaluation, medical monitoring, and/or medically necessary treatment or services for a WTC-related or medically associated health condition be in accordance with the rates paid under the Federal Employees’ Compensation Act (FECA), administered by the U.S. Department of Labor (DOL). Pursuant to 42 C.F.R. § 88.22(b), treatment for which FECA rates have not been established will be reimbursed at the applicable Medicare fee for service rate, as determined appropriate by the Administrator. Treatment for which neither FECA nor Medicare fee for service rates have been established will be reimbursed at rates determined appropriate by the Administrator. More information about FECA, including the methodologies used to calculate FECA rates, can be found at http://www.dol.gov/compliance/laws/comp-feca.htm. Maximum payments under the WTC Health Program are the lesser of the calculated fee schedule amount or the billed amount.
2. The WTC Health Program also follows DOL’s medical fee schedule used by the FECA program for covering inpatient hospital services. These services are subject to a reimbursement schedule based on the Medicare Inpatient Prospective Payment System (IPPS). That system assigns services to Diagnosis-Related Groups (DRGs) and adjusts rates for individual hospitals according to their specific cost index. Inpatient services not covered under the Medicare IPPS are reimbursed under a formula that is based on the cost-to-charge ratio (CCR) data tables published by CMS for rural and urban hospitals in each state. The full explanation of how fees are calculated under FECA may be found at: http://www.dol.gov/owcp/regs/feeschedule/fee/fee12/READ_ME_FIRST_fs12_instructions.htm.

8. Billing

As noted in the Overview above and in Chapter 4, Medical Benefits, billing for covered services under the program is consistent with industry best practices and uses standard procedures and forms. The categories of health conditions are defined by ICD-10 diagnosis codes. The medical services associated with each covered condition/diagnosis code are defined by Current Procedural Terminology (CPT), Healthcare Common Procedure Coding System (HCPCS), DRG, and Revenue Coding Center (RCC) codes. These codes, documented appropriately on standard CMS-1500, UB-04, and EDI claims, are the basis by which member claims are paid. The codes acceptable for submission of claims for healthcare services for covered conditions under the Program have been defined and are documented in the Codebook, found in the WTC Health Program file of record.

9. Unlisted and Miscellaneous Procedure Codes

Special circumstances apply when considering the use of a procedure or service code that is not currently listed in the Codebook.

1. Unlisted codes are CPT or HCPCS codes that are not associated with a specific procedure or service. Miscellaneous codes are used for procedures, devices or supplies, and services that have not been assigned a unique CPT code. Because both of these types of codes are not usually associated with a single service, they are typically not priced and reimbursement must be determined on a case-by-case basis. Providers should only use these codes when a more specific code is not available. The unlisted codes provide the means of reporting and tracking services and procedures until a more specific code is established, and are not typically used for reimbursement purposes. When these codes are used, they should be accompanied by documentation to support medical necessity. The MBM will determine on a case-by-case basis whether a particular code will be covered and, if covered, the Program prices the code depending on the procedure or service performed.
2. If a CCE/NPN requests that an unlisted code or miscellaneous code be added to the WTC Health Program Code book through the medical change request process, the Program’s Medical Benefits Team will determine if there is a more appropriate procedure or service code available that closely approximates the service or procedures needed to be performed.
3. Since unlisted codes and miscellaneous codes lack definition, they will be reviewed by the WTC Health Program for proper code use. All unlisted and miscellaneous codes require supporting documentation, which must be submitted with the claim to facilitate review as to code use justification. If use of the code is justified, the claim will be approved, and a reimbursement amount will be calculated. In the course of the medical review process, the WTC Health Program may ask for additional documentation.
4. When submitting supporting documentation, the medical provider or CCE/NPN should underline or highlight the portion of the note or report that identifies the test or procedure associated with the unlisted or miscellaneous procedure code. Required information must be legible and clearly marked. Documentation must clearly describe a condition and the medical need for the procedure or service. It should also include an explanation of the following:
   1. Whether the service was performed alone or in conjunction with other services;
   2. Whether the procedure was performed at the same surgical site or through the same surgical opening as another procedure;
   3. Any extenuating circumstances which may have complicated the service or procedure;
   4. The time, effort, and equipment necessary to provide the service;
   5. The number of times the service was provided; and
   6. Evidence of cost or charges expected for the procedure.
5. No fee schedule amount has been established for unlisted and miscellaneous codes, and they are carried in the system as having a zero dollar amount. If use of the code is approved, the amount payable for the service will be determined on a case-by-case basis, using the documentation provided by the submitter. Therefore, it is important for the submitter to provide enough detail on the cost and charges for the unlisted or miscellaneous procedure so that the program is able to arrive at a reasonable decision regarding the reimbursable amount.
6. No additional reimbursement is provided for special techniques/equipment submitted with an approved unlisted procedure code.
7. Unlisted CPT-4 procedure codes should not be billed with a modifier or they will be denied. However, unlisted codes for DME, orthotics, and prosthetics require appropriate NU (for new equipment), RR (for rental equipment) or MS (for maintenance and servicing) modifiers.
8. When performing two or more procedures that require the use of the same unlisted CPT code, the unlisted code should only be reported once to identify the services provided (excludes unlisted HCPCS codes - for example, DME/unlisted drugs). If the procedures or services are the same, then the code would be listed once and the units used to describe how many times the service or procedure was performed or rendered. If the procedures or services are different, but require the use of the same unlisted code, then the additional instance of the code must be billed in a separate claim.
9. If claims with unlisted or miscellaneous procedure codes are submitted without supporting documentation, a reasonable attempt will be made by the Program to obtain supporting documentation. If no documentation is forthcoming, or documentation is insufficient, the claim will be denied.
10. The Program will not routinely accept retrospectively amended medical records or physician queries beyond 60 days from the service date. The Program determines the extent of medical documentation required to support use of the code as a basis for coverage or reimbursement upon review or physician query.
11. Clinical documentation or physician queries amended over 60 days from the service will not be accepted to defend reimbursement, increase reimbursement, or consider a previously denied claim. If there are extenuating circumstances, the CCE/NPN must contact the Program to present their circumstances, and the Program will consider each situation on a case by case basis.
12. The following chart shows the type of documentation required for different codes (in addition to the list found in item d above):
    
    

    Procedure Code	Documentation
    10021–69990: Surgical Procedures	Operative or Procedure Report
    70010–79999: Radiology/Imaging Procedures	Imaging Report
    80048–89356: Laboratory & Pathology Procedures	Laboratory or Pathology Report
    90281–99602: Medical Procedures	Office Notes and Report
    Unlisted DME HCPCS Codes: Equipment/Supply	Provide Narrative on the Claim

10. Payments and Remittance Advice

On a weekly basis, claim lines are gathered into a claim payment run (or file) which is transmitted to the payment contractor. The process is outlined in the below graphic.

1. The HPS contractor forwards two files to the payment contractor - a file that generates payments and a file to generate RAs.
2. The payment contractor runs the data through a series of edits to ensure 1) format compliance and 2) correct calculations for payments. It also conducts a “pre-note” process, in which it sends a $0 payment to each provider’s bank account to verify all banking information. If any errors are found, the payment contractor notifies the HPS contractor so that the Member Services team can be engaged to correct the information.
3. The payment contractor then processes the data through established channels at CMS to send a payment file to the Treasury Department, which issues EFT payments to the providers. The payment contractor issues RAs detailing the claims processing outcomes to providers in either an electronic or paper format, or both, depending on the provider’s preference.
4. The payment contractor sends a confirmation file back to the HPS contractor after each week’s payment run which documents what was paid and whether any payments were rejected. The HPS contractor then updates the claims processing software with this data so that the status of all claims can be tracked.
5. Payments for pharmaceuticals are sent to the PBM, which forwards them to the dispensing pharmacies.

11. Payment Reporting

Using MicroStrategy’s business intelligence reporting tool, Microstrategy 9, and Quantum Choice, a variety of reports are generated to provide the WTC Health Program insight into the claims and payments processed, and to ensure quality assurance of the claims processing function.

1. Claims and payment reports for the WTC Health Program’s and providers’ use include a breakdown of medical claims, claim metrics report, medical claim dollars, denied/returned claims, and so forth.
2. Reports for use by the HPS contractor to ensure quality assurance and allow resolution of unique claims include reports of pended claims by age and institutional claims with National Correct Coding Initiative (NCCI) edits.
3. In addition to standardized reports, ad hoc reports may be generated, as necessary, to provide the Program with detailed insight into the characteristics of Program enrollees, providers, and claims.

12. Payment Reconciliation and Auditing

Accurate payments and timely payment corrections, when necessary, are important to maintain the integrity of the WTC Health Program. The Program has an established process to ensure payments are accurate.

1. The HPS contractor reconciles payment data with the payment contractor on a monthly basis to ensure accuracy and alignment of records.
2. If a discrepancy or imbalance is found, the HPS contractor researches and resolves the issue.
3. Over payments are recovered by withholding from future payments. Checks and cash are not to be sent to the HPS contractor to correct over payments.
4. Under payments are rectified by payment adjustments, i.e., making an additional payment.
5. Processed claims are regularly audited to ensure accuracy of payments under the Program. Prior to the implementation of auto-adjudication, 100 percent of processed claims were audited for accuracy. With the implementation of auto-adjudication in September 2012, audits are performed on 2 percent of the claims that are not auto-adjudicated, and focuses on both ensuring processors are resolving edits correctly and on keying accuracy, in accordance with industry standards. Processes for measuring the quality of auto-adjudicated claims and post-payment utilization review are currently in development.

13. Appeal of Reimbursement Denial

After exhausting procedural and/or contractual administrative remedies, a CCE or NPN medical director or affiliated provider may submit a written appeal of a WTC Health Program decision to withhold reimbursement or payment for treatment found to be not medically necessary or not in accordance with approved Program medical treatment protocols. Appeal procedures will be published on the WTC Health Program website.

14. Appendices

5-A - CMS-1500
5-B - UB-04
5-C - Policy and Procedures for Coordination of Benefits for Treatment Costs for Non-Work-Related, Certified WTC-Related Health Conditions: Coordination with Health Insurance
5-D Policy and Procedures for Recoupment: Lump-Sum Workers' Compensation Settlements
5-E Policy and Procedures for Recoupment & Coordination of Benefits: Workers’ Compensation Payment

Chapter 6 – CCEs and Providers

1. Purpose and Scope

The purpose of this chapter is to provide a high-level overview of the Clinical Centers of Excellence's (CCEs’) roles, responsibilities and processes for the WTC Health Program. In addition to this procedure manual, further details regarding CCE operations can be referenced in the CCE Clinical Guide and the CCE Operations Manual developed by each CCE, both found in the Program’s file of record. Of note, the Nationwide Provider Network (NPN) is discussed separately in Chapter 8 of this manual.

2. Statutory and Regulatory References

This chapter is guided by Sections 3305(a)(1) and 3305(b)(1) of the PHS Act, which describe requirements for the contracts put in place with the CCEs, as well as various sections of 42 C.F.R. Part 88. In addition, the CCEs play a pivotal role in implementing the general provisions of the Act, as described below.

3. Roles and Responsibilities

The roles and responsibilities associated with the CCEs and providers in the WTC Health Program are detailed below.

1. CCEs are the NY metropolitan area-based medical facilities that, in accordance with the Act, operate under individual contractual relationships with NIOSH to provide medical monitoring examinations, diagnosis, and treatment services for eligible persons in the NY metropolitan area. Members are each assigned a CCE which is responsible for coordinating their care under the WTC Health Program. CCE responsibilities include, but are not limited to:
   
   
   1. Using an integrated, centralized health care provider approach to create a comprehensive suite of health services that are accessible to enrolled WTC responders, screening-eligible survivors, or certified-eligible survivors;
   
   
   2. Having experience in caring for WTC responders and screening-eligible survivors, or includes health care providers who have received WTC Health Program training
   
   
   3. Employing health care provider staff with expertise that includes, at a minimum, occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social services counseling; and
   
   
   4. Meeting such other requirements as specified by the Administrator of the WTC Health Program. For example, each CCE must:
      • Manage a provider network to ensure members have access to the necessary expertise required to treat their certified covered conditions;
      • Submit periodic reports to the Program regarding its compliance with WTC Health Program regulations, guidelines, and contract requirements; and
      • Coordinate with the WTC Health Program Data Centers (DCs) in collecting and analyzing programmatic data.
   
   
2. With regard to the CCEs, the Program has the responsibility to certify conditions submitted by the CCEs, informing members of the acceptance or denial of coverage and ensuring WTC Health Program claims submitted by the CCEs and their external providers are paid. The Program also communicates regularly with the CCEs to clarify, modify, or establish WTC Health Program policies and procedures, and is responsible for oversight of CCE operations to determine if the CCEs are operating within the WTC Health Program regulations, guidelines, and contract requirements.


3. The Health Program Support (HPS) Contractor, under the direction of the WTC Health Program leadership, provides the information technology and program management support that are essential to WTC Health Program CCE operations. The HPS contractor processes claims submitted by the CCEs and their associated providers, coordinates member enrollment and eligibility, supports the authorization of CCE providers, provides call center support, and coordinates with CCEs to provide requested reports and data analysis.

4. CCE Experience and Personnel

The WTC Health Program CCEs offer unique expertise in the provision of healthcare services to NY metropolitan area-based members. Currently, there are seven CCEs that provide WTC Health Program services:

• Five CCEs serving general responders:
  
  
  • Northwell Health (Northwell)
  • Mount Sinai School of Medicine (MSSM)
  • New York University School of Medicine (NYU)
  • State University of New York, Stony Brook (SUNY)
  • Rutgers University (RU)


• One CCE devoted specifically to Fire Department of New York (FDNY) Responders (FDNY)


• One CCE devoted specifically to survivors of the WTC attacks in NYC – NYC Health + Hospitals System (H+H) WTC Environmental Health Center

1. CCE Experience
   
   Each CCE is experienced in providing healthcare services of a type similar or greater in scope, size, and complexity to those required under the WTC Health Program. Relevant experience includes providing initial and medical monitoring evaluations, diagnostic and treatment services, member services, and administrative services. The current CCEs demonstrated this experience through participation in the predecessor programs described in the “History of the WTC Health Program” section of Chapter 1.
   
   
2. Personnel
   
   Each CCE employs healthcare provider staff with expertise that includes, at a minimum, occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social services and benefits counseling.
   
   Each CCE employs a Clinic Director and a Clinic Administrator to oversee medical and administrative aspects of the CCE’s participation in the WTC Health Program. The Clinic Administrator is responsible for all operational aspects of the WTC Health Program at the CCE.

5. CCE Operations Overview

Each CCE operates under contract with the federal government to administer healthcare (within the limited care model defined by Title XXXIII of the PHS Act) to the responders or survivors of the September 11, 2001, terrorist attacks. (The NPN, discussed in Chapter 8, provides care for enrolled members residing outside the NY metropolitan area, including responders to the plane crashes in Shanksville, PA, and Arlington, VA – the site of the Pentagon.) Each CCE is responsible for all aspects of WTC Health Program-related care for each member they serve. In addition to services provided directly by the CCEs, services are also provided through the CCEs by external providers who have expertise in the diagnosis and treatment of 9/11-related health conditions and have been approved by the CCEs and the Program to provide WTC Health Program benefits. Section 6 below provides more detail regarding external providers.

Each CCE educates its staff and network providers in WTC Health Program policies and procedures such as the proper completion of paperwork, limitations of coverage, protocol changes, and benefits counseling, and maintaining a complete Operations Manual to document them. CCE representatives participate in periodic meetings with the Program leadership, their associated data center, the HPS contractor, and other vendors, as required, to coordinate activities, address and resolve issues, and share information.

The work performed by CCEs is grouped into the following four categories and is discussed in detail, below:

• Monitoring and Initial Health Evaluations


• Treatment Services


• Member Services


• Administrative Services

As provided by the PHS Act, the WTC Health Program reimburses providers for healthcare expenses for health conditions that have been certified by the Administrator of the WTC Health Program as WTC-related or as medically associated to a certified WTC-related health condition. Health condition certification is required for treatment services to be paid by the Program. The certification of a WTC-related or medically associated condition is based on a review of a CCE physician’s clinical assessment of the relationship between a given Program member’s WTC exposure and the type and temporal sequence of symptoms, or diagnosis, of a qualifying health condition. This review must find that the member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks is substantially likely to be a significant factor in aggravating, contributing to, or causing the health condition.

A list of the ICD-10 diagnosis codes that correlate with the List of WTC-Related Health Conditions and medically associated health conditions covered by the Program is found in the WTC Health Program Codebook. CCEs provide guidance to external providers on allowable benefits, including proper use of the WTC Health Program Codebook if disseminated.

A member’s health benefit profile is comprised of all Care Suites and certification gates that reflect the conditions that have been certified for that member (Care Suites are discussed in section 9 of Chapter 3 of this manual). The member benefit profile continues to be updated to reflect any new conditions that are certified over time. The claims processing system verifies that each health care service claim line maps a medical procedure to a diagnosis contained within the Care Suites and certification gates comprising a member’s benefit profile.

A.   Monitoring and Initial Health Evaluations
Each CCE schedules and provides a baseline exam for new enrollees and follow-up monitoring examinations to WTC responder and certified-eligible survivor members as applicable. The purpose of the monitoring exams is to: (1) provide periodic physical and mental health assessment designed to identify acute and latent health effects that are WTC-related; (2) serve as an avenue for clinical data collection, analysis and reporting to ensure that all services provided adhere to the appropriate protocols; and (3) inform the diagnosis of WTC-related diseases that could lead to a referral for treatment. The table below describes the extent of these exams.




If a test result indicates the presence of a WTC-related condition, or is inconclusive, the monitoring physician will refer the member for additional diagnostic testing and/or treatment.

1. Monitoring Exam Process and Protocols
   
   Monitoring services performed by the CCE must addhere to the following processes
   and protocols:

• The CCE must use a form such as a Medical History Questionnaire (MHQ), which comprises standardized assessment instruments for multiple physical and mental health conditions.
  
• The MHQ must be administered by a Registered Nurse (RN) who has received training in the proper completion of the MHQ.
• To ensure quality assurance, a representative sampling of 10 percent of all Pulmonary Function Testing (PFT) results is sent to the WTC Health Program each month for review by the Medical Benefit Manager (MBM).
• When all exam inventories and tests are completed, the RN prepares a summary report for the monitoring physician. The summary report contains information from the MHQ and results from the laboratory tests, chest X-ray, and spirometry, as well as a summary of the member’s past medical records on file at the CCE.
• The monitoring physician reviews the summary report, conducts a clinical interview and a physical examination, and synthesizes the clinical information for discussion of findings and any needed treatment referrals with the program member. The clinical interview must be conducted by a qualified physician, preferably one specializing in occupational medicine.

Medical Monitoring Evaluation Process

The CCE medical monitoring evaluation process consists of the following tasks:

• Scheduling the exam for the member with a provider in the CCE.
• Summarizing prior medical records (including prior claims information) and ensuring that the medical monitoring exam physician has a copy of the summary report prior to the scheduled physical exam appointment.
• Conducting the Medical History Questionnaire interview using RNs.
• Performing the required lab work, chest radiograph, and spirometry test.
• Ensuring that the medical monitoring physician has a summary of the Medical History Questionnaire interview, a summary of the prior treatment records, if available, and the prior medical monitoring exam records in time for the scheduled physical exam.
• Issuing a letter which reports the results of the medical monitoring examination to the member.
• The CCE is required to ensure that medical monitoring examinations are coded correctly, using appropriate formats as described in Chapter 5, and that claims are submitted promptly to the HPS contractor for claims processing.
• The monitoring exam provider coordinates with the CCE Clinic Director to obtain additional testing or subspecialty evaluation, when necessary, for further diagnosis of suspected WTC-related conditions.
• If a physician determines that a member has a WTC-related health condition, the CCE completes the WTC-3 package and submits it to the WTC Health Program MBM for certification, following the procedure outlined in Chapter 3.
• The CCE must follow appropriate authorization channels for treatment services and prescriptions issued under the program, as described in Chapter 4, as well as for coordinating referrals for treatment of covered conditions.
• Each CCE must explain to the members it serves what monitoring and treatment benefits are provided under the WTC Health Program, and that no treatment benefits are provided under the Program for non-covered conditions.
• CCEs provide social services to its members that are applicable to their coverage under the Program. For example, the CCE may offer case management services or assistance with locating community support for members who need it.
• In order to ensure quality assurance, CCEs conduct regular checks on their implementation of the medical monitoring process, as well as the appropriateness and completeness of the medical records maintained by the CCE, and the Program conducts quarterly audits
• CCEs prepare and submit claims for processing and payment to the PM&A contractor after reviewing and approving each for accuracy.
• Working with its associated DC, each CCE reviews and transmits treatment data to the DC for use in WTC Health Program-related research.
• The CCE must develop protocols or procedures for the following medical monitoring exam-related issues, working in conjunction with their respective DC. These protocols or procedures are approved by the Administrator of the WTC Health Program or designee and communicated by the CCE to its staff, as appropriate. The protocols and procedures include:
  • Obtaining relevant CCE medical records for individuals previously served by another CCE
  • Quality assurance protocols which are built upon accepted practice guidelines
  • Scheduling medical monitoring exams
  • Determining the methodology by which monitoring examination services are delivered
  • Ensuring that proper data from the exams are sent to the DC for research and analysis purposes
  • Ensuring that a letter is sent to the member informing him or her of the exam results within two weeks of the completion of the monitoring exam
  • Preparing and submitting claims for all medical monitoring exam-related services
  • Collecting and maintaining all records required for project management and reporting
  • Handling emergency situations or managing crises that may arise during monitoring, treatment, case management, or other member interaction

Diagnosis

1. No WTC-Related Health Condition. If the medical monitoring exam does not lead to the diagnosis of a WTC-related covered health condition, or if no treatment is required, the member will be scheduled for the next medical monitoring exam in 12 months.
   
2. WTC-Related Health Condition. If the medical monitoring exam reveals a health condition that is on the List of WTC-Related Health Conditions and the physician determines it relates to exposure from the September 11, 2001, terrorist attacks, the CCE prepares a WTC-3 certification package as described in Chapter 3, and promptly transmits it to the Program for certification of the member’s health condition.
   

Additional Medical Testing Required

In order to ensure adherence to monitoring protocols, the CCE Clinic Director must approve any additional medical testing proposed by the examining physician to confirm a diagnosis of a WTC-related health condition. Once the CCE Clinic Director’s authorization has been obtained, CCE staff assists the member in scheduling appointments to obtain the additional medical testing.

Records, Member Notification and Claims

1. Records. After a medical monitoring exam has been completed, the CCE ensures that all completed medical monitoring records are maintained by the CCE in accordance with best-practice medical records storage and privacy standards.



2. Member Notifications. The CCE provides a letter to each member informing him or her of the results of the medical monitoring exam within 2 weeks of the completion of the exam.



3. Claims. In accordance with the processes described in Chapter 5, the CCE submits a claim for the monitoring exam and services to the HPS contractor for claims processing, using the codes identified in the WTC Health Program Codebook for monitoring.

Treatment Services

Once a member has been diagnosed with a WTC-related health condition and that condition is certified by the Program, the member is eligible to receive treatment for that condition when treatment is indicated. Diagnostic and treatment services for members are delivered through an assigned provider at the member’s CCE or its referral network of authorized external providers.

1. Treatment Covered By Codebook. Treatment is provided in accordance with the procedures and services authorized for the care of each certified condition, as established in the WTC Health Program Codebook. Care must meet the medically necessary criteria of the WTC Health Program, guided by the Program’s treatment protocols and outlined in multiple source documents, including the WTC Health Program Codebook, WTC Health Program policy bulletins, and in the Clinical Center and Provider Guides, all maintained in the WTC Health Program file of record.
   
   It is incumbent upon CCE providers to understand the logic of the Codebook, and to be familiar with the codes that are covered by the Program so they can assign them properly for data analysis, reporting, and billing purposes.
   
   
2. Treatment Not Covered by Codebook. When a CCE determines that a treatment or prescription medication that is not covered by the Program is a legitimate, medically necessary requirement for treatment of an enrolled member’s certified condition, the CCE may submit a request to add the service to the Codebook via the Change Management Process described in Chapter 4.
   
   The CCE is responsible for ensuring that all treatment providers are knowledgeable about the specific health conditions, procedures, and medications covered by the Program, including the appropriate procedures for handling non-covered health conditions, medical emergencies and appeals.

Claims

Providers may submit claims as an individual provider or as part of a provider group. If medical treatment services are provided in a group setting, the group must be enrolled in the WTC Health Program as a group provider. Each of the CCEs has established methods for claims submission with the WTC Health Program. For specific guidance between an external provider and a CCE, it is always best to consult with the respective CCE directly. In general:

• Claims submitted through a third party administrator (TPA) are considered to be authorized by the CCE which has engaged the TPA.


• Claims submitted from external providers directly to the WTC Health Program are not considered to be authorized, unless other arrangements have been made with the Program.

For services provided by a clinician in his or her offices, claims submitted on paper rather than Electronic Data Interchange (EDI) must use a Professional claim form (CMS-1500). For inpatient or outpatient hospitalizations, claims submitted on paper rather than EDI should use an Institutional claim form (UB-04). Professional services provided in a hospital setting that are not included in the institutional billing should be billed on the CMS-1500 form.

Paper claims originating with external providers must first be submitted to the appropriate CCE. The CCE is responsible for authorizing treatment for the member. Therefore, the CCE must review and authorize claims to be processed. A stamp provided to the CCE by the WTC Health Program is used for this purpose, along with initialing by an authorized CCE approver. Once approved by the CCE, paper claims should be submitted to the WTC Health Program for processing and disposition (i.e., payment, partial payment, or denial). The information entered on the claim form is captured through an automated data collection process; therefore, all paper claim submissions must be legible and of sufficient quality for imaging. Information must be completed in the appropriate field on the billing form in order to expedite claims processing.

Pharmacy Benefit

Pharmacy benefit plans have been implemented to improve oversight and minimize fraud, waste, and abuse.

1. The CCE is expected to follow the WTC Health Program-approved Routine Diagnostic Plan and the four treatment plans that govern the pharmacy benefits to which members are entitled. Further details regarding the specifics of the pharmacy benefit may be found in Chapter 4, as well as in the Program’s Codebook and bulletins, specifically WTC Health Program Bulletin 13-2 titled, “Implementing Pharmacy Benefit Plans by Health Condition Certification Status,” both located in the Program’s file of record.


2. Should a prescription be denied, the CCE has the opportunity to override the denial using the PBM’s online adjudication tool. Chapter 5 provides more detail.


3. The physicians who are permitted to prescribe under the WTC Health Program are limited to those providers who have been authorized by the CCEs. Weekly updates of permitted prescribers are sent by the CCEs to the PBM, which shares this information with the HPS contractor. If a provider is permitted to prescribe medications under the WTC Health Program, the provider’s prescriber status is recorded in the claims processing system’s Provider Module.

Member Services

Each CCE develops and implements procedures for providing services to its members.

1. Member Retention
   
   Each CCE is responsible for conducting activities that enable the CCE to maintain contact with enrolled members and promote their continued participation in the Program. Each CCE must attempt to update contact information for all members assigned to that CCE on an annual basis. Contact methods include mailings, telephone calls, or emails and contact attempts should continue until the member is contacted or until three attempts have been made using at least two methods of contact.
   
   
2. Outreach and Education
   
   CCEs conduct outreach and education to ensure that those persons who are eligible for care through the WTC Health Program are made aware of their eligibility and know how to enroll in the Program. Outreach is specifically not intended to advertise one CCE over another, but rather to advertise the existence of the WTC Health Program and to ensure the Program’s benefits are communicated to all eligible participants. CCE outreach and education activities are undertaken in coordination with Program leadership and the HPS contractor, which operates the Program’s call center. Types of outreach and education services include:
   
   
   • Answering general questions in regard to program eligibility processes
   
   
   • Collaborating with the Program leadership, appropriate DC, and other CCEs in standing up and maintaining a Section 508-compliant Website to provide WTC Health Program information for the members being served. Explaining members’ rights and responsibilities under the Program
   
   
   • Collaborating with the Program leadership, appropriate DC, and other CCEs in providing program information updates to members and providers (e.g., newsletters, letters, brochures, email)
   
   
   • Explaining the process for obtaining WTC Health Program services
   
   
   • Providing information on the providers from whom WTC Health Program members may obtain services
   
   
   • Fielding and responding to member questions and complaints received regarding the WTC Health Program benefits and/or services (i.e., captured from member satisfaction survey, a resource line, or Case Managers)
   
   
   • Advising members of the available appeals process and the member’s rights to a fair review
   
   
   • Providing program benefits counseling, which includes explaining the benefits and covered services offered under the WTC Health Program, including WTC-related health conditions and medically associated WTC-related health conditions and limitations, and any conditions associated with the receipt or use of benefits


3. Case Management
   
   Each CCE provides case management services to all members in treatment. The role of the Case Manager is to address the unique healthcare needs of individual members and improve client satisfaction with the program. Case Managers assist in scheduling visits, coordinating care between providers, and facilitating appeal requests.


4. Social Services Support
   
   CCEs must provide social service evaluations and assistance to Program members, when needed. These services include assistance with identifying and completing applications to access social programs outside the WTC Health Program when assistance is needed with housing, transportation, food, or medical services that are not covered by the Program.
   
   
5. Medical Reviews
   
   If a member’s CCE physician is unable to make the necessary findings regarding WTC-relatedness of a condition and/or refuses to submit a request for certification to the WTC Health Program, or refuses to provide or seek authorization for a particular treatment for a covered condition, the member may request a review of that physician decision by the CCE Clinic Director. The member is instructed to send a letter to the CCE Clinic Director describing why he or she believes the physician’s decision was incorrect. The CCE Clinic Director reviews the request and provides the member with the final decision and the rationale for it. The CCE furnishes a copy of the letter to the Program and keeps records of the review process in its files for audit purposes. The CCE also tracks such decisions and makes recommendations to the Administrator of the WTC Health Program, as appropriate, when such decisions may require adjustments to program treatment protocols.
   
   
6. Workers’ Compensation Assistance
   
   WTC Health Program members who experienced a health condition resulting from work they performed as part of their job duties when responding to the WTC attacks may be eligible to apply for workers’ compensation benefits. Upon request, CCEs must provide assistance to members who are applying for workers’ compensation benefits due to a WTC-related health condition, such as helping to document the member’s health condition and treatment needed. CCEs must also provide requested assistance to providers in completing required workers’ compensation paperwork. Because there may be an extended period of time between the time a claim is filed and when benefits are awarded, the CCE’s provision of care and submission of claims must not be influenced by or changed due to expected workers’ compensation benefits.
   
   In general, the overall order of payors for responders in the WTC Health Program is as follows: Workers’ compensation (for a WTC-related or medically associated health condition that is work-related),* followed, in order, by the WTC Health Program, private health insurance, Medicare, and Medicaid. In most cases involving WTC-related health conditions that are work-related, however, only Workers’ Compensation and the WTC Health Program will be called upon to make payments for Program members’ care.
   
   The exception to the order of payors provided above is where a Program member’s WTC-related or medically associated health condition is eligible for workers’ compensation or another illness or injury benefit plan to which New York City is obligated to pay. In this case, the WTC Health Program is the primary payer.
   
   The WTC Health Program follows the provisions in Title XXXIII of the PHS Act regarding Coordination of Benefits (COB) for survivors. Workers’ compensation is a required part of COB for responders and, in certain limited situations, survivors.
   
   The overall order of payors for survivors in the WTC Health Program is as follows: Workers’ compensation (applicable only if WTC-related condition is a work-related illness for which a claim has been established),* private health insurance, followed by Medicare, then Medicaid, and finally the WTC Health Program. Requirements for billing under the COB policy for survivors provide that, where applicable, payment for services must first be sought from:
   
   
   • Private Health Insurance: Where the WTC- related or medically associated health condition is not work-related, and where the member has private health insurance coverage, the private health insurance must be billed prior to billing the WTC Health Program.
   
   
   • Public Health Insurance (Medicare/Medicaid): Where the WTC-related or medically associated health condition is not work-related, and where the member does not have private health insurance but is covered by Medicare or Medicaid, those entities must be billed (in that order) prior to billing the WTC Health Program.
   
   The total payment, including any amounts paid by other entities and by the WTC Health Program, will not exceed the fee schedule used by the WTC Health Program. If the primary payor already paid up to the fee schedule amount, no additional payment is made under the WTC Health Program.
   
   If prior payments were made by another entity, those payments should be shown when the claim is submitted to the WTC Health Program.
   
   *Note: The WTC Health Program established a process to recoup from workers’ compensation after payment of claims to the CCEs. Therefore, the CCEs are not responsible for billing workers’ compensation for WTC Health Program claims prior to either submission to the Program in the case of responders or private/public insurance in the case of survivors.


7. Member Transfers
   
   In the event that a member requires transfer from one CCE to another, the CCEs follow their established procedures for assisting with the transfer by coordinating with each other. The “sending” CCE will share appropriate medical records and other data and provide any information the member and “receiving” CCE may need to ensure seamless care. Transfers between the NY metropolitan area CCEs are available to any non-FDNY responder. FDNY responders who are active members of FDNY are not eligible for transfer to another CCE as care is provided through the FDNY at its Bureau of Health Services. All NY metropolitan area survivors are initially assigned to HHC; all non-NY metropolitan area members are initially assigned to the NPN. Additional information on member transfers can be found in Chapter 9, Member Services.

Administrative Services

Each CCE must develop and implement certain procedures for providing administrative services to support the WTC Health Program. These procedures are documented in each CCE’s Operations Manual.

1. Healthcare Provider Network
   
   Each CCE has established and maintains an adequate healthcare provider network to serve all members who are assigned to the CCE. This network may include, but is not limited to, hospitals, specialty clinics, trauma centers, specialists, and primary care physicians. The CCEs are responsible for providing healthcare expertise in sufficient numbers and at convenient locations for the members. Providers may be either internal or external to the CCE establishment. An example of an internal provider is a respiratory therapist on the CCE’s staff; an example of an external provider is a psychiatrist in private practice who has been authorized to provide WTC Health Program services on behalf of the CCE. Each CCE is responsible for ensuring that all healthcare providers serving the WTC Health Program meet all requirements of the CCE’s contract, including that they comply with all workers’ compensation requirements and are properly licensed and insured. The physicians who conduct the medical monitoring assessments and physicals must be experienced in practicing occupational medicine (e.g., conducting occupational health screening and medical surveillance) - preferably credentialed as occupational medicine specialists. Additional information on the Provider Network is found in Section 6 below.


2. Credentialing
   
   Each CCE has established and implements a credentialing process for its provider network to ensure all providers are qualified to provide care under the WTC Health Program. Each CCE submits key information on each provider to the HPS contractor so the providers can be entered into the claims processing system. The credentialing process is documented in each CCE’s Operations Manual.
   
   
3. Training
   
   Each CCE ensures that all providers and other personnel who perform work for the WTC Health Program are properly trained – both initially and on an ongoing basis – to perform their assigned functions. This training includes:
   
   
   • Potential exposures and health outcomes that have been associated with the WTC terrorist attacks
   • The conditions and services covered by the WTC Health Program
   • Proper coding of and billing for WTC Health Program services
   • How to ensure compliance with the WTC Health Program policies and procedures
   • Avenues for problem-solving, escalation of concerns, etc.
   
   Training processes and procedures are further described in each CCE’s Operations Manual.


4. Pharmacy Benefit Management (PBM)
   
   Each CCE works with the WTC Health Program PBM to provide pharmacy benefits to its members, as described in Chapters 4 and 5. By providing names of and pertinent data on authorized prescribers to the PBM, each CCE validates to the Program that those writing prescriptions under the WTC Health Program are authorized to do so. CCEs also play a role in the management of pharmacy benefits when overrides or prior authorizations are needed to ensure members receive needed medications. These processes are described further in Chapter 5.
   
   
5. Quality Assurance and Internal Audits
   
   Each CCE has established a quality assurance function to ensure high-quality care of WTC Health Program members in accordance with all Program policies and procedures. Responsibilities for quality assurance include:
   • Ensuring adherence to monitoring and treatment protocols
   • Providing benefits counseling for workers’ compensation and other insurance programs, as necessary
   • Appropriately billing for only WTC-related health conditions and medically associated health conditions
   • Ensuring appropriate diagnostic and treatment referrals for members, when necessary
   • Verifying prompt communication of test results to members
   • Reviewing all claim forms and other contract deliverables for completeness and accuracy
   • Measuring, monitoring, and increasing member satisfaction
   • Improving overall program success
   • Ensuring early identification and resolution of problems, issues, and risks
   • Monitoring of adherence to established policies and procedures
   • Continuous process improvement and implementation of lessons learned
   
   
   1. Quality Assurance Program (QAP)
      
      Each CCE is responsible for developing, implementing, and documenting its approach to quality assurance. CCEs each have developed a WTC Health Program-specific Quality Assurance Program (QAP) which describes the procedures used to monitor and improve all Program activities, including reporting. To ensure consistency among CCEs and alignment with WTC Health Program goals and objectives, each CCE’s QAP must be approved by the Administrator of the WTC Health Program or designee.
   
   
   2. Customer Satisfaction Survey Program (CSSP)
      
      A Customer Satisfaction Survey Program (CSSP) is part of every CCE’s QAP. In this program, members are given the opportunity on an annual basis to complete a customer satisfaction survey.
      
      Each CCE must report findings from its customer satisfaction survey to the Administrator of the WTC Health Program or designee. These findings include frequency and method of surveys, survey results, and corrective actions to be taken based on survey results
   
   
   3. Internal Audits
      
      As a part of its QAP, each CCE conducts an internal audit at least once a quarter. These audits include:
      
      
      • Targeted Health Care Compliance – The Targeted Health Care Compliance audit focuses on evaluating the adequacy of the procedures used by the CCE to ensure that only approved WTC health conditions and approved health care services (including provider visits, procedures, medication and durable medical equipment) are reimbursed by the Program. This includes a review of documentation justifying payment history for medically associated health conditions.
      
      
      • Medical Management Review – The Medical Management Review audit looks to ensure that medical practice guidelines developed for the Program are being followed.
      
      
      • Claims History – The Claims History audit focuses on irregularities in the claims history of any particular provider or member.
      
      
      • Medical Records Review – The Medical Records Review audit focuses on determining if appropriate procedures are being followed related to the collection, review, and storage of medical records.
      
      
      • Personnel Training – The Personnel Training audit focuses on ensuring that all personnel performing work on the Program are properly trained.
      
      
6. Records Management
   
   Each CCE is responsible for administering a comprehensive records management program which ensures that all Program records, including medical records, are maintained in such a manner that the information is secure and readily accessible to authorized parties. For all protected health information (PHI), this includes compliance with all Health Insurance Portability and Accountability Act (HIPAA) requirements. The CCEs must provide the Administrator of the WTC Health Program with a copy of their Notice of Use and Disclosures of Protected Health Information required by the HIPAA privacy rule and ensure in that notice that the members are aware that the Administrator of the WTC Health Program and/or his designee will have access to the members’ protected health information for the purposes of the treatment provided by and administration of the WTC Health Program. The records management program includes providing assistance to members in obtaining medical records and processing member requests to release protected information. In addition, each CCE has the capability for a medical records locator to facilitate the retrieval of all medical records from any provider for any member within the CCE or their referral network.



7. Other Administrative Responsibilities
   
   Additional responsibilities of the CCE include:
   • Attending administrative, steering, benefits, and clinical WTC Health Program meetings
   • Writing reports and Institutional Review Board (IRB) submissions
   • Entering data for claims submission and to meet reporting requirements
   • Entering data of healthcare information into the DC’s data system
   • Providing intellectual input on the refinement of medical guidance and protocols as needed by the program (and coordinated by the DC), or in support of member treatment needs
   • Providing administrative personnel and facilities to support the CCE’s contract
   • Providing translational and interpretive services for non-English-speaking members, as appropriate to the CCE’s member population
   
   

6. Provider Networks

The establishment and management of the internal and external provider network are coordinated through the respective CCEs. In order for a provider to have a claim for WTC Health Program services paid, the CCE must have enrolled the provider as a participating provider in the WTC Health Program. Provider enrollment into the WTC Health Program and the management of a reliable provider network are critical to efficient claims processing. The complete and accurate enrollment of providers ensures that claims are not suspended for review of provider validity issues, and that claims may be promptly adjudicated.

Each CCE is responsible for submitting provider enrollment requests to the HPS contractor and updating provider details when necessary. All medical providers, including physicians, group practices, hospitals, Durable Medical Equipment (DME) suppliers, nursing facilities, hospice services, and others, must enroll as participating providers in the WTC Health Program for claims to be adjudicated through the Program’s claims processing system. Each CCE determines the nature of its provider relationships (i.e., internal or external) and is also responsible for providing the appropriate level of education and information regarding the Program to external providers so that they may provide an approved level of care for WTC Health Program-certified conditions.

The HPS contractor uses the information provided by the CCEs to add providers to the claims system.

1. Internal Provider
   
   The internal provider network is comprised of healthcare providers (both individuals and groups) that have established relationships as internal medical providers with the medical institutions that are managed by each respective CCE. For example, the Mount Sinai School of Medicine (MSSM) is a medical facility within the purview of the MSSM CCE; most, if not all, of the physicians and groups who practice at the MSSM are enrolled as internal MSSM providers. The designation of “internal” provider is relevant during claims processing, as a claim received by an internal provider is considered to be already authorized by the managing CCE through the nature of the provider’s relationship to that CCE’s affiliated institution(s).


2. External Provider
   
   The majority of the enrolled WTC Health Program providers are external to a CCE. The external provider network comprises healthcare providers (both individuals and groups) that have contractual relationships to provide medical services for members assigned to a particular CCE. External providers may be affiliated with more than one CCE. The designation of “external” provider is relevant during claims processing, as a claim received by an external provider is not considered to be authorized by the managing CCE unless the claim shows an official stamp indicating CCE authorization is submitted by EDI. Claims submitted by the TPA are assumed authorized because of procedures established by the CCEs and the TPA ensuring claims are authorized before they are submitted to the program for payment. The process for authorizing claims is described in Chapter 5.
   
   After a CCE has established either an internal or external relationship with a provider, the CCE must submit a provider enrollment request to the HPS contractor for processing. CCEs must provide the following data:
   
   
   • Provider/Practice Name
   • Provider/Practice Address (must not be a PO Box)
   • Provider/Practice Telephone/Fax Number
   • Provider/Practice National Provider Identifier (NPI) Number
   • Provider/Practice Social Security Number (SSN)/Employer Identification Number (EIN)
   • Provider Medicare Number (if provider will be submitting institutional claims)
   • Billing Provider/Practice Name
   • Billing Provider/Practice Address (can be a PO Box) where Remittance Advice (RA) may be sent
   • Billing Provider/Practice NPI Number
   • Billing Provider/Practice EIN
   • Financial Information (can be submitted on an Electronic Funds Transfer [EFT] Form), including
     • Financial Institution Name
     • Financial Institution Address
     • Financial Institution Routing Transfer Number
     • Depositor Account Number
   
   
   Financial information is also provided using an EFT Form or other document provided by the Program so that providers may receive payment for their claims.
   
   Before submitting the provider enrollment, the CCE confirms: 1) that all data are complete and accurate; 2) that the provider’s status as either an internal or external provider is documented; and 3) whether the provider should also be enrolled with the following specialties:
   
   
   • Rx Prescriber - this is not a required data element, but if this information is not provided, the record will default to “Not an Rx prescriber” and the provider will not be able to write prescriptions for members.
   
   
   • Cancer Care Provider - this is not a required data element, but if this information is not provided, the record will default to "Not a cancer provider." As of April 26, 2013, an open prescriber network for members assigned to the Cancer Treatment Plan became effective, permitting cancer care providers to prescribe certain drugs for cancer care. For all other non-cancer formulary drugs, a provider must be flagged as "Rx prescriber" in order to authorize prescriptions.
   
   
   Once a provider enrollment has been received and validated by the CCE, the CCE submits the enrollment to the HPS contractor for processing. If incomplete information is received, the enrollment form will be returned to the CCE for completion. Chapter 9 provides more detail regarding the steps taken to complete the enrollment process.
   
   The management and maintenance of the information in a provider record are the CCEs’ responsibility. Changes to provider information may be necessary over time (e.g., an address or financial information changes, or a provider ceases her association with the WTC Health Program). Any changes to provider information that are received by the CCEs are processed in the same way as for an initial enrollment. Changes to provider information that are not first identified by the CCE must be routed to the CCE for validation and to ensure consistency among, and accuracy of, Program records. This could occur, for example, when a claim being processed for payment reveals that the provider’s EFT information has changed
   
   
3. Annual Confirmation of Authorized Providers
   
   Enrollment and management of a reliable provider network is critical to ensure that claims will efficiently and accurately adjudicate. In the interest of supporting the CCEs’ responsibility to manage their provider and prescriber enrollees, the HPS contractor annually distributes to each CCE a list of all its providers enrolled in the Program. The CCE must review the list and make any updates or note any discrepancies between the providers held on record by the Program and those held on record by the CCE. The HPS contractor is responsible for working with the CCE to resolve any discrepancies in a timely fashion.

7. Reporting Requirements

CCEs have a number of reporting requirements regarding activities undertaken on behalf of the WTC Health Program.

1. Monthly Reports

   Each CCE submits to the Program monthly status reports on member and administrative services activities to allow Program leadership to track the CCE’s program activities and progress. In addition to summarizing the activities and accomplishments of the past month, the report identifies any potential risks to continued program success and communicates the CCE’s plans to mitigate those risks. A variety of reports are required, as detailed below.

   1. Member Services Monthly Report. The content of the Member Services Monthly Report is reflected in the following table.
      

      Member Service Function

      Information to Be Reported

      Member Retention

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Member Retention services performed during the period and the associated cost for these services invoiced to the government.

      Member Outreach and Education

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Member Outreach and Education services performed during the period and the associated cost for these services invoiced to the government.

      Program Benefits Counseling

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Program Benefits Counseling services performed during the period and the associated cost for these services invoiced to the government..

      Case Management

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Case Management services performed during the period and the associated cost for these services invoiced to the government.

      Social Services Functions

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Social Services Functions performed during the period and the associated cost for these services invoiced to the government.

      Member Transfers

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Member Transfer services performed during the period (including the status of all outstanding requests for medical records) and the associated cost for these services invoiced to the government.

      Medical Reviews

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Administrative Services related to Medical Reviews that were performed during the period and the associated cost for these services invoiced to the government.

      Workers’ Compensation Assistance

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Workers’ Compensation Assistance performed during the period and the associated cost for these services invoiced to the government.

      Other Member Services

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Other Member services performed during the period and the associated cost for these services invoiced to the government.

   
   
   
   2. Administrative Services Monthly Report. The content of the Administrative Services Monthly Report is reflected in the following table.
      
      

      Administrative Service Function

      Information to Be Reported

      Healthcare Provider Network

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Healthcare Provider Network services performed during the period and the associated cost for these services invoiced to the government.

      Pharmacy Benefit Management

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Pharmacy Benefit Management services performed during the period and the associated cost for these services invoiced to the government.

      Quality Assurance and Internal Audits

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Quality Assurance and Internal Audits performed during the period and the associated cost for these services invoiced to the government.

      Records Management

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Records Management services performed during the period and the associated cost for these services invoiced to the government.

      Transfer of Data and Information (at the end of the contract)

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Transfer of Data and Information services performed during the period and the associated cost for these services invoiced to the government.

      Attending administrative, steering, benefits, and clinical WTC meetings

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all attendance at administrative, steering, benefits, and clinical WTC meetings during the period and the associated cost for these services invoiced to the government.

      Report Writing and IRB Submissions

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Report Writing and IRB Submissions that were performed during the period and the associated cost for these services invoiced to the government.

      Data Entry for Claims Submission and to Meet Reporting Requirements

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Data Entry services performed during the period and the associated cost for these services invoiced to the government.

      Data Entry of Healthcare Information into the DC’s Data System

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Data Entry services performed during the period and the associated cost for these services invoiced to the government.

      Healthcare Protocol Development - provide intellectual input on the refinement of medical guidance and protocols as needed by the program (and coordinated by the DC), or in support of member treatment needs

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Healthcare Protocol Development services performed during the period and the associated cost for these services invoiced to the government.

      Providing Translational and Interpretive Services

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Providing Translational and Interpretive Services performed during the period and the associated cost for these services invoiced to the government.

      General and Administrative Charges

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all General and Administrative Charges during the period and the associated cost for these services invoiced to the government.

      Other Administrative Services

      A complete listing of activities, descriptions of activities, number of actions, and evaluation of effectiveness of all Other Administrative Services performed during the period and the associated cost for these services invoiced to the government.

   
   
   
   3. Other sections of the Monthly Report are reflected in the below table.
      

      Operations Manual

      Difficulties encountered and proposed updates to the Operations Manual. Updates shall be approved by the Administrator of the WTC Health Program after review and discussion of the issues, as needed.

      Complaints

      A summary of all complaints received by the CCE during the preceding month and the status of their resolutions.

      Fraud and Abuse Report

      A) The CCE shall submit monthly the number of complaints of fraud or abuse made to the CCE related to covered services that warrant preliminary investigation by the CCE. B) The CCE shall also submit to the Administrator of the WTC Health Program the following on an ongoing basis for each confirmed case of fraud or abuse it identifies through complaints, organizational monitoring, contractors, subcontractors, providers, and members, etc. related to covered services: 1) The name of the individual or entity that committed the fraud or abuse; 2) The source that identified the fraud or abuse; 3) The type of provider, entity or organization that committed the fraud or abuse; 4) A description of the fraud or abuse; 5) The approximate dollar amount of the fraud or abuse; 6) The legal and administrative disposition of the case including actions taken by law enforcement officials to whom the case has been referred; and 7) Other data/information as prescribed by the Administrator of the WTC Health Program. Such report shall be submitted when cases of fraud or abuse are confirmed, and shall be reviewed and signed by an executive officer of the CCE.

      
      
      
2. Additional Administrative Reports
   
   Other operational data reports may be required from time to time to support the needs of the Program. In such cases, the Administrator of the WTC Health Program or designee will work with the CCEs to coordinate the content of the report and delivery details, as necessary. An example of such a report is the Customer Satisfaction Survey report.

8. CCE Operations Manual

Each CCE has developed a CCE Operations Manual which has been approved by the Administrator of the WTC Health Program. The manual must be updated at least quarterly to reflect changes in WTC Health Program policies and procedures and includes the following:

• Protocols for medical monitoring exam-related issues, working in conjunction with the CCE’s respective DC
• Protocols for treatment-related issues
• Procedures for providing member services: member retention; outreach and education; benefits counseling; case management; social services; and medical appeals
• Details of the medical review process and records system
• Details of the Workers’ Compensation Assistance program
• Details of the member transfer process
• Details of the quality assurance program
• Details of establishing and credentialing the CCE’s provider network
• Details of the training program
• Details of the records management program
• Details of the transfer of data and information and turnover of services procedure
• Details of other administrative services provided

Coming Soon

Chapter 7

Chapter 8- Nationwide Provider Network

1. Purpose and Scope

The purpose of this chapter is to provide a high-level overview of the Nationwide Provider Network (NPN) contractor’s roles, responsibilities, and processes for the WTC Health Program. In addition to this Administrative Manual, further details regarding NPN operations can be referenced in the NPN Operations Manual developed by the NPN and found in the Program’s file of record. Of note, the Clinical Centers of Excellence (CCEs) are discussed separately in Chapter 6 of this manual, while the process for certification of health conditions is provided in Chapter 3, and information on medical benefits are provided in Chapter 4.

2. Statutory and Regulatory References

The NPN is responsible for implementing the general requirements of the Act, with its function, roles, and responsibilities specifically guided by the following sections:

• Section 3313, which describes the national arrangement for benefits for eligible individuals outside the New YorkC, (NY) metropolitan area:
• Section 3312(b)(4)(C), which includes coverage for certain transportation expenses incurred by members securing medically necessary treatment through the NPN, and
• Section 3305(a)(2)(A)(iv), which calls for the Data Centers (DCs) to establish the criteria for credentialing medical providers who participate in the NPN.

3. Roles and Responsibilities

The roles and responsibilities with respect to the NPN are detailed below.

1. The NPN provides monitoring and treatment benefits for individuals who are enrolled WTC responders or certified-eligible WTC survivors and initial health evaluations for screening-eligible WTC survivors who reside in any state outside the NY metropolitan area, including those responders from Shanksville, PA, and Arlington, VA, the site of the Pentagon. After receiving information regarding approved enrollees from the Health Program Support (HPS) contractor, the NPN enrolls the new members into its system and reaches out to them to educate them regarding NPN processes for obtaining covered benefits. The NPN must maintain a viable provider network to provide monitoring and treatment to NPN members, with services available across the country to ensure access near members’ areas of residence. The NPN forwards medical claims to the HPS contractor for payment, and disburses payments to its subcontracted providers.


2. The Program has the responsibility to communicate regularly with the NPN to clarify, modify, or establish WTC Health Program policies and procedures, and provides oversight of NPN operations to verify that the NPN is operating within the WTC Health Program regulations, guidelines, and contract requirements. It also ensures that claims submitted by the NPN’s providers are paid by the HPS contractor.


3. The HPS contractor, under the direction of the WTC Health Program leadership, provides the information technology and program management support services that are essential to WTC Health Program NPN operations. The HPS contractor processes claims submitted by the NPN’s providers, provides weekly updates on new enrollees to the NPN, supports the authorization of NPN providers, provides contact center support, and coordinates with the NPN to provide requested reports and data analysis.
   

4. Overview of NPN Services

The NPN manages a network of providers who are licensed, credentialed, insured and/or certified in accordance with the WTC Health Program requirements. Participating providers receive training on WTC Health Program covered health conditions and protocols from the NPN. In many cases, an enrollee may receive care from more than one NPN provider. The chart below describes the process used by the NPN to select and maintain providers within the NPN provider network.

4.1 Credentialing and Re-credentialing Process

The NPN has a team of individuals whose responsibility it is to ensure all Healthcare Practitioners (HCPs) within the NPN are licensed within the state where they will be performing services. The NPN ensures that all HCPs have unrestricted, valid current licenses, certifications, and registrations as required for their particular profession within the state, district or territory in which they are performing services. The NPN uses both trained credentialing staff and an accredited Credentialing Verification Organization (CVO) to meet the provider credentialing requirements of its WTC Health Program contract.

The NPN tracks the credentialing requirements in its data system (MedNet) for each provider to ensure all documentation is accurate and current.

A qualifying practitioner is not activated within the NPN until the credentialing verification process is complete and the NPN Medical Director has provided final approval. The NPN performs ongoing monitoring to identify any sanctionable activities or instances of malpractice, fraud, waste or abuse. HCPs are re-credentialed every 36 months.

All subcontracted providers receive training and monitoring of their quality of care and overall performance in the provision of clinical services. All providers receive training from the NPN’s Medical Provider Training department prior to scheduling appointments. Forms, procedures and expectations are reviewed in the initial training session to ensure compliance with WTC Health Program processes.

4.2 NPN Member Eligibility and Enrollment

As Chapter 2 details, eligibility for all members of the WTC Health Program is determined by the Program. Members are assigned to the NPN by the Program based on their geographic location. These WTC Health Program members may be newly enrolled members or members who transfer from a CCE.

Newly enrolled WTC Health Program members are assigned to the NPN by the WTC Health Program’s Member Services Team based on the new member’s location outside the NY metropolitan area. If a newly enrolled WTC Health Program member who has not been assigned to the NPN contacts the NPN directly, the NPN will work with the member and the Program to confirm eligibility and assignment.

If a WTC Health Program member wishes to transfer from a CCE to the NPN or from the NPN to a CCE, the NPN and relevant CCE will work together to coordinate the transfer using the established WTC Health Program transfer policy, detailed in the Member Services Operations Manual.

The NPN sends each WTC Health Program member who has been assigned to the NPN a Welcome Packet that includes the following materials:

• Welcome letter;
• Frequently Asked Questions handout;
• Workers’ compensation application¹; and
• Medical record release forms (only for members transferring from a CCE to ensure continuity of care)

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¹In accordance with Section 3331 of the James Zadroga 9/11 Health and Compensation Act of 2010, WTC Health Program members whose covered conditions are also covered under workers’ compensation may have their payments reduced or recouped to the extent that payment has been made or is reasonably expected to be made under workers’ compensation law.

4.3 Scheduling, Intake Interview, Testing, and Monitoring Exams

Coordination of member intake is managed by the NPN case manager. Ongoing communication with a WTC Health Program member occurs through a variety of media, as necessary, including telephone, email, and fax, and may include the use of Integrated Voice Recognition (IVR) technology.

Pre-scheduling Activities

New Member: The NPN contacts the member to answer questions and schedule an initial monitoring exam or initial health evaluation. Since the member is not transferring from a WTC Health Program CCE, there are no prior medical records to retrieve.

Transfer Member: The NPN contacts the member to answer questions and encourage the member to return the Medical Record Release Form(s), provided in the Welcome Packet. The NPN makes up to six call attempts to reach the member to obtain the completed Medical Record Release Forms, as necessary. Once the forms are received, the NPN coordinates with the member’s CCE to collect the medical records via trackable shipping service, enters information from the records into the NPN database (MedNet) and assigns a case manager to review the records and document the member’s WTC-certified health conditions and medical history. Upon completion of documentation, the case manager schedules the intake interview.

The intake process consists of three parts: an intake interview; testing; and a monitoring exam or initial health evaluation.

Intake Interview Since NPN members are located throughout the country, face-to-face meetings are not feasible, so the NPN case manager conducts intake interviews by telephone. During the intake interview, the case manager verifies all demographic information with the member, making updates when necessary, in order to ensure proper identification and confidentiality. A Medical Health Questionnaire (MHQ) is completed by the case manager and typically takes between 45 minutes to 1 ½ hours. The MHQ is completed for both new WTC Health Program members and transfers into the NPN to ensure completeness of NPN documentation. If a member uses English as a second language and prefers to speak his/her primary language, the NPN engages a company that offers interpreter services to assist in interpreting the interview.

The NPN must ensure a provider is available who is located within 30 (urban)/75 (rural) miles of the member’s home of record. If a member requests a specific provider who is not currently in the NPN network, the NPN will initiate attempts to bring the provider into the network. If attempts to contract with the provider are not successful, the case manager works with the member to identify a provider who will meet both the member’s needs and the requirements of the Program.

After the MHQ is conducted, the case manager schedules testing and monitoring exam or initial health evaluation appointments with the assigned provider. These appointments are scheduled immediately for new members; for transfers into the NPN, the appointments are scheduled based on the due date of the member’s next exam. All eligible members are encouraged to have an annual monitoring exam.

Testing and Monitoring Exams The initial monitoring exam or health evaluation is consistent with those performed by the CCEs and includes a review of the completed MHQ, a general health assessment, vital signs assessment, spirometry testing, blood work, urine collection, and a chest X-ray. The follow-up monitoring exam, where appropriate for the type of member, includes the same components as the initial monitoring exam with the exception of the chest X-ray, which is performed every two years unless an increased frequency is clinically indicated. Follow-up exams or additional testing, scheduled through the case manager, may be required as a result of the monitoring exam to complete a diagnosis. Chapter 6 provides more detail on the components of the monitoring exams.

Within 48 hours of a member completing his/her appointment(s), all documentation is forwarded from the provider to the NPN so that the NPN Clinical Director may determine whether or not to request certification of a health condition. Chapter 3 provides detailed information regarding the certification process. The NPN scans all received documents and archives them in its database (MedNet). The completeness of the documents is reviewed using a system-generated checklist. If any required materials are missing, the NPN contacts the provider to retrieve the missing component(s) and/or to complete any missing exam elements. In the event providers are not completing the exams/evaluations accurately or completely, re-training may be recommended.

Inform Member of Results Once all documents are received by the NPN and quality reviews are completed, the case manager conducts a thorough review of the exam findings and drafts a letter to the member informing him/her of the results and any referrals to the treatment program that stemmed from their exam. All exam results are sent no later than two weeks after the monitoring exam or health evaluation services have been completed.

If referrals are identified, the case manager follows up with the member within five days after the letter and exam/evaluation documentation has been sent to the member to discuss the conclusions reached from the initial work-up and the member’s ongoing participation in the Program. The case manager discusses covered health conditions and assists in the coordination of treatment, as necessary. Additionally, the case manager outlines those health conditions that the member may have that are not covered under the WTC Health Program and instructs the member to see his/her primary care provider for treatment of those health conditions. If necessary, the case manager engages the NPN social worker who assists in the processing of social work referrals and benefits counseling for the member.

The NPN’s Social Services Specialist will reach out to provide assistance when a member’s answer to the MHQ either in the mental health section or social benefits section indicates it may be needed, when a need is identified by the case manager through conversation with the member, or when a monitoring exam/initial health evaluation physician identifies the need for a social service referral. Areas of need addressed may include utility needs such as electricity and heating, transportation needs, mental health needs, assistance with Victim Compensation Fund questions, coordination of benefits with other programs such as Medicaid or workers’ compensation, provision of guidance in accessing resource programs such as food stamps or financial assistance, offering guidance in accessing medication assistance or medical assistance programs, providing assistance in accessing local resources in other regions of the country, or other items as requested by the member.

If referrals are not indicated as part of the monitoring exam/initial health evaluation, a reminder is entered into MedNet to begin the process for scheduling the next monitoring exam 60 days prior to its due date, where appropriate.

4.4 Treatment Services

If a member is referred for treatment, the NPN will begin the request for certification process for all covered health conditions which the clinical director determines that the member’s exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition. Chapter 3 describes the process for certifying covered conditions under the program. When a member’s health condition is approved for certification by the WTC Program, the Program notifies the NPN electronically, and sends the member a letter to inform him/her of the Program’s decision.

The NPN also issues a Member ID Card to all NPN members consistent with the Program’s practices for all members. The card contains a member identification number and the customer service telephone numbers for the NPN and the Pharmacy Benefits Manager (PBM).

4.5 Processing and Paying Claims

The NPN reimburses every subcontracted provider within 30 days of receipt of their invoice. In order to receive reimbursement, the services rendered must be medically necessary,performed completely and in accordance with the NPN’s authorization, protocols, and direction.

Upon receipt of an invoice, the NPN reviews it for accuracy and completeness. Once the NPN determines that the invoiced services are appropriate and in accordance with WTC Health Program requirements, the invoice is electronically submitted to the HPS contractor for processing and payment. If the NPN determines that the invoiced services are not in accordance with Program requirements, it denies the invoice and sends the provider a letter of explanation permitting the provider to correct any errors and, if appropriate, resubmit a corrected claim to the NPN. See Chapter 5 for more detail on how NPN medical and pharmaceutical claims are processed paid and can be appealed.

Chapter 9 - Member Services

1. Purpose and Scope

The purpose of this chapter is to provide an overview and description of the member services provided through the WTC Health Program under the James Zadroga 9/11 Health and Compensation Act of 2010 (the Act). A member is defined as an individual who is enrolled in the WTC Health Program as a responder, certified-eligible survivor, screening-eligible survivor, or eligible family member of an FDNY responder.

2. Statutory and Regulatory References

The following Sections of the Act are applicable to this chapter (42 C.F.R. pt. 88 does not include any language specifically applicable to this chapter):

1. Section 3303 of the Act describes the education and outreach services that are required under the WTC Health Program. These services include the following activities and are conducted in a manner intended to reach all affected populations and to support culturally and linguistically diverse populations:
   1. Establish public Website with information about the WTC Health Program;
   2. Meet with potentially eligible populations;
   3. Develop and disseminate outreach materials informing people about the Program; and
   4. Establish phone information services.
2. Sections 3305(a)(1)(B-D) and 3305(a)(2)(A)(iii) of the Act discuss the roles of the Clinical Centers of Excellence (CCEs) and Data Centers (DCs) in providing outreach activities.

3. Responsibilities

Member services are a key function of most WTC Health Program entities.

1. The CCEs are responsible for working with newly enrolled WTC Health Program members to assist them in accessing the benefits of the Program, including scheduling appointments, as needed. Member services provided by the CCEs include conducting member retention activities, supporting member transfers, reviewing and transmitting completed health certification requests to the WTC Health Program, issuing social services referrals, providing workers’ compensation assistance, conducting internal audits, managing media relations, and ensuring accurate records management. In addition to providing medical care, CCEs have an integral role in providing a range of member services to the people they serve. CCE staff meet with potentially eligible populations and existing members face-to-face to provide benefits counseling and other information regarding the services available to them. They assist members in completing application forms and, when requested, submit the forms to the Program on the members’ behalf. The CCEs also work closely with community, labor union, and governmental stake holders to develop a variety of materials and plans for educating members and the public about the Program.
2. The Nationwide Provider Network (NPN) is responsible for working with newly enrolled Program members who live outside the New York (NY) metropolitan area to assist them in accessing the benefits of the program, including scheduling appointments, as needed. Member services provided by the NPN include conducting member retention activities, supporting member transfers, reviewing and transmitting completed health certification requests to the WTC Health Program, issuing social services referrals, providing workers’ compensation assistance, conducting internal audits, managing media relations, and ensuring accurate records management.
3. The DCs help coordinate activities with the CCEs, as appropriate.
4. The Health Program Support (HPS) contractor receives and processes enrollment forms, requests for certification of health conditions, claims for payment of medical benefits, and other correspondence and inquiries from members, CCEs, medical providers, pharmacies, and others. As part of its support, the HPS contractor manages phone information services through its contact center.
5. The WTC Health Program Member Services Team serves as the government lead in providing Program-wide oversight for member services, including outreach and education, communications, retention, member complaints, and appeals. It also manages the WTC Health Program Website, which serves as a primary source of information about the program, providing links to CCEs, the NPN, the contact center, and a wealth of resources for members’ use. The team establishes standards and templates for communicating Program decisions to members, responds to email inquiries, processes enrollments, maintains provider enrollments, and develops informational materials and communications.

4. Communication Activities

A variety of activities are implemented to ensure effective and full communication with all Program stakeholders.

1. A comprehensive public Website is maintained at https://www.cdc.gov/wtc/. This Website provides background information on and news about the WTC Health Program; information, links, and downloadable forms for those who wish to apply; resources specific to each category of member; links to guiding legislation, regulations, and supporting documents; and the location and links to each of the CCEs and the NPN.
2. A WTC Health Program newsletter is published periodically by the Program and includes benefit updates, health information, details on enrollment procedures, and other articles of interest to updates, health information, details on enrollment procedures, and other articles of interest to Program participants. The newsletter is mailed to every enrolled member of the Program, with additional copies distributed to CCEs and outreach and education contractors (described further in Section 5 below) for recruitment and outreach activities, and is also posted on the WTC Health Program Website.
3. A variety of letters are sent to members, including welcome letters that are sent to new members when they are enrolled in the Program; update/status letters that are sent to members at various points during the enrollment, certification, and appeal processes; and periodic special mailings to inform members of Program-wide matters. The Member Services Team is responsible for developing all letters sent to WTC Health Program members, with final review and approval by the Member Services Team Lead and the Office of the General Counsel (OGC).
4. Email communication with members is managed to ensure accuracy and transparency in Program communications. In addition to individual Program staff email accounts, the WTC Health Program maintains a general mailbox that is accessible from the WTC Health Program Website (WTC@CDC.gov).
   1. The WTC inbox is checked daily. Most responses are personalized and sent within 24-hours after receipt of an inquiry.
   2. As needed, responses that require input from other WTC Health Program team members (e.g., the claims manager, a particular CCE, or the NPN) will be routed accordingly.
   3. Member personal and medical information is handled in a manner that preserves and protects privacy and confidentiality in accordance with all legal requirements ¹. This includes, but is not limited to, the maintenance of medical records in a secure environment and the education of Program staff regarding confidentiality. The Program will not release medical information without authorization, except as required or permitted by law to administer benefits, comply with government requirements, or if you consent to participate in research or education.
   
   
5. Additional communication mechanisms are described below in Section 5, Outreach and Education.

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¹The WTC Health Program protects member information in accordance with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104–191; 42 U.S.C. § 1320d); the Health Information Technology for Economic and Clinical Health (HITECH) Act (Pub. L. 111-5; 42 U.S.C. §§ 300jj et seq.); the HIPAA Privacy, Security, Breach Notification, and Enforcement Rules (45 C.F.R. pts. 160, 162, and 164); and HHS HIPAA policies.

5. Outreach and Education

The Program has a variety of mechanisms in place to communicate Program benefits to and meet with potentially eligible populations.

1. a. Outreach materials are developed in English, Spanish, Chinese, and Polish and are widely disseminated through a variety of mechanisms to inform potentially eligible populations about the Program and to encourage those eligible to apply. A comprehensive list of current material can be found online at https://www.cdc.gov/wtc/outreach-materials.html. Materials are also created to communicate changes in Program benefits or procedures to current members. Examples include, but are not limited to:
   1. A flyer describing the enrollment process for eligible members;
   2. Palm cards and bus ads to encourage enrollment;
   3. A letter and Frequently Asked Questions (FAQ) document regarding the addition of cancer to the list of covered conditions; and
   4. A detailed FAQ document describing the NPN;
   5. Video testimonials for the WTC Health Program Website.
2. Several organizations have been funded through contracts to provide additional outreach and education services on behalf of the Program. These contractors are detailed athttps://www.cdc.gov/wtc/outreach.html and in the following table:
   
   

   Contractor	WTC Health Program Outreach and Education Activities
   9/11 Environmental Action	The 9/11 Environmental Action (9/11 EA) project will utilize innovative social networking techniques, web-based film clips in English, Spanish and Chinese, and traditional outreach methods, to reach as broad a population as possible. The project will disseminate information about who is eligible for WTC Health Program membership for the Survivor Program (including the Pediatric Program), the Responder Program or the National Program and provide guidance on how to enroll. 9/11 EA will closely partner with the survivor organization, StuyHealth, to reach a population of former students, now young adults, locally and nationally. The project will focus mainly on survivors, but includes a significant component of outreach to 9/11 disaster relief volunteers. 9/11 EA will collaborate with the Ground Zero Fellowship to reach a responder population of affected disaster relief volunteers, locally and nationally.
   FealGood Foundation, Inc.	FealGood Foundation |Outreach & Education (FGF OnE) will assist First Responders in the NYC Area and other identified areas of need who may have been injured, physically or mentally as a direct result of their rescue, recovery and clean-up efforts at the World Trade Center Site. FGF OnE will conduct four large events to assist in registering the Responders in World Trade Center Health Program.
   New York Committee for Occupational Safety and Health (NYCOSH)	NYCOSH will reach responders through one-on-one engagement directed at union members. Establishing one-on-one contact with these individuals through their organizations and working to ensure that they understand their potential benefits, how to apply to the program, and are guided through the application process itself is the critical next phase of this project.
   Voices of September 11th	Voices of September 11th (VOICES) provides a wide range of support services and programs to address long-term needs of those impacted by 9/11. The plan for outreach is broad-based and uses proven engagement techniques, direct-contact printed materials, web-based activities and social networks as well as community-based and corporate presentations, conferences and forums. The plan targets outreach to companies, organizations, local residents, and subgroups such as parents, immigrants, seniors, retirees and children.

   
   
3. Various events are planned and conducted by the CCEs and contractors to inform potential members and the general public about the program. The CCEs and contractors also participate in health fairs and forums and prepare additional outreach materials, as necessary.
4. Public service advertisements aimed primarily at survivors are developed. Informational posters have been placed in prominent locations, such as free tax preparation sites, where potentially eligible survivors may be more likely to see them.
5. In addition to print materials and advertising, the Program uses Web-based platforms like Wikipedia (http://en.wikipedia.org/wiki/World_Trade_Center_Health_Program) and Twitter (https://twitter.com/search?q=World%20Trade%20Center%20Health%20Program&src=typd) as well as regularly updating the Program Website to keep information about the Program current.

6. Member Retention

The CCEs and the NPN are responsible for undertaking activities designed to retain members in the Program. These activities include maintaining regular contact with currently enrolled members and encouraging these members to continue to participate in the program. See Chapter 6 for additional information about CCE member retention activities, and Chapter 8 for additional information about NPN member retention activities.

7. Phone Information Services

The Program has established comprehensive phone information services via its Member Call Center to support education and outreach activities.

1. The Program’s Call Center is available at 1-888-982-4748 (1-888-WTC-HP4U), Monday through Friday 9:00am - 5:00pm Eastern Standard Time to answer questions from members, providers, pharmacies, and others.
2. Call Center staff have access to information on a variety of Program-related services and resources, making the Call Center a primary vehicle through which the Program answers individual questions regarding Program benefits, activities, eligibility, enrollment, claims, and so forth.
3. In addition to the Program’s Call Center, each CCE and the NPN also maintain phone information services to meet the needs of their member-specific populations. All contact information is accessible at www.cdc.gov/wtc/clinics.html.

8. Appeals

The Member Services team also coordinates appeal processes for the Program. Members may appeal decisions made regarding denial of enrollment, a decision to disenroll the member from the Program, a decision not to certify a health condition as a WTC-related condition, a decision not to certify a health condition as medically associated with a WTC-related health condition, a decision to decertify a health condition, or a decision not to authorize treatment due to a determination by the WTC Health Program that the treatment is not medically necessary for the certified health condition. Appeals are specific to the type of decision rendered. A comprehensive discussion of the appeals process may be found at www.cdc.gov/wtc/appeals_enrollment.html.

Summaries of the appeals processes may be found in Chapter 2, Eligibility and Enrollment, for denials of enrollment and disenrollments; Chapter 3, Certification of Health Conditions, for denials of certification of a health condition and decertification; and Chapter 4, Medical Benefits, for denial of treatment authorization. Appendix 9-A contains a fact sheet, distributed to any members receiving a denial decision for certification of a health condition, which outlines the appeals process.

9. Member Concerns

Member concerns are addressed through a variety of mechanisms. In addition to the regular communication channels available to members (described above) through which concerns may be expressed, the Program also hears concerns through ad hoc meetings with stakeholders and community groups and via individual communications on a case-by-case basis. Because of the close working relationships and frequent communication between the Program and member groups, the Program has multiple, regular opportunities to identify and address member concerns. Member concerns are also reviewed through congressional inquiries and through letters sent by members directly to the Program or to the Administrator.

Appendices 9

9-A - A Overview of the Appeal Process for Denial of Health Condition Certification
9-B - WTC Health Program—Notice of Privacy Practices

Fraud, Waste, and Abuse

1. Purpose and Scope

The purpose of this WTC Health Program Fraud, Waste, and Abuse (FWA) policy is to describe the measures taken to prevent, detect, and deter the FWA of public funds. FWA activities target the potential causes of FWA from inadvertent errors to willful deception.

The scope of the WTC Health Program FWA policy includes all areas of the WTC Health Program that could be vulnerable to FWA. These areas include, but are not limited to

• Member Eligibility and Enrollment (Section 4.1)
• Outreach and Education (Section 4.2)
• Provider Credentialing and Registration Section 4.3)
• Health Condition Certification (Section 4.4)
• Medical Benefits (Section 4.5)
• Pharmacy Benefits (Section 4.6)
• Payment for Healthcare Services (Section 4.7)
• Payment for Pharmacy Benefits (Section 4.8)
• Recoupment Activities (Section 4.9)
• Program Performance. (Section 4.10)

2. Statutory and Regulatory References

The Public Health Service Act

The following sections of Title XXXIII of the Public Health Service (PHS) Act are applicable to this chapter:

1. Section 3301(d)(1)-(2):
   1. FRAUD. -- The Inspector General of the Department of Health and Human Services shall develop and implement a program to review the WTC Program’s health care expenditures to detect fraudulent or duplicate billing and payment for inappropriate services. This title is a Federal health care program (as defined in section 1128B(f) of the Social Security Act) and is a health plan (as defined in section 1128C(c) of such Act) for purposes of applying sections 1128 through 1128E of such Act.
   2. UNREASONABLE ADMINISTRATIVE COSTS. – The Inspector General of the Department of Health and Human Services shall develop and implement a program to review the WTC Program for unreasonable administrative costs, including with respect to infrastructure, administration, and claims processing.
2. Section 3305(b)(1)(B)(iv) states that a Clinical Center of Excellence (CCE) must agree to:
   4. Have in place safeguards against fraud that are satisfactory to the Administrator and consistent with the Inspector General of the Department of Health and Human Services.

https://www.gpo.gov/fdsys/pkg/USCODE-2015-title42/pdf/USCODE-2015-title42-chap6A-subchapXXXI.pdf

Other laws and statutes also have direct impact on protecting against FWA. Federal laws include, but are not limited to, the following:

• The Health Care Fraud Statute (18 U.S.C. § 1347)
• The False Claims Act (18 U.S.C. §§ 3729 – 3733)
• The Anti-Kickback Statute (42 U.S.C. §§ 1320a-7b)
• Exclusion Provisions (42 U.S.C. § 1320a-7)
• The Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a)

Health Care Fraud Statute

The Health Care Fraud Statute makes it a criminal offense to knowingly and willfully execute a scheme to defraud a health care benefit program. Health care fraud is punishable by imprisonment for up to 10 years. It is also subject to criminal fines of up to $250,000. Specific intent to violate this section is not required for conviction. 18 U.S.C. § 1347.

https://www.gpo.gov/fdsys/pkg/USCODE-2015-title18/pdf/USCODE-2015-title18-partI-chap63-sec1347.pdf

False Claims Act

The False Claims Act establishes civil liability for offenses related to certain acts, including knowingly presenting a false or fraudulent claim to the government for payment, and making a false record or statement that is material to the false or fraudulent claim. “Knowingly” includes not only actual knowledge but also deliberate ignorance or reckless disregard for the truth or falsity of the information. No specific intent to defraud the government is required. Depending on the circumstances, some examples of potential False Claims Act violations in the health care fraud context include upcoding, billing for unnecessary services, billing for services or items that were not rendered, and billing for services performed by an excluded individual. 31 U.S.C. § 3729.

Individuals and entities that make false claims are subject to civil penalties of up to $11,000 for each false claim, plus three times the amount of damages the government sustains by reason of each claim. Violation of the False Claims Act may lead to exclusion from Federal health care programs. 31 U.S.C. § 3729.

Civil legal actions for penalties and damages under the False Claims Act may be brought not only by the government, but by private persons, such as competitors or employees of a provider, on behalf of the government. If the legal action is successful, the private person is entitled to a percentage of the recovery. The False Claims Act protects all persons from retaliation for reporting false claims or bringing legal actions to recover money paid on false claims. 31 U.S.C. § 3730.

Failure to return overpayments may lead to liability under the False Claims Act. Under section 1128J(d) of the Social Security Act, persons who have received an overpayment from a Federal health care program must report and return the overpayment within 60 days of the date the overpayment was identified. Failure to do so may make the overpayment a false claim. 42 U.S.C. § 1320a-7k; 31 U.S.C. § 3729.

False claims made knowingly may also be subject to criminal prosecution. Persons who knowingly make a false claim may be subject to criminal fines up to $250,000 and imprisonment of up to 5 years. 18 U.S.C. §§ 287; 3571.

Anti-Kickback Statute

The Anti-Kickback Statute, found in Section 1128B(b) of the Social Security Act, prohibits the knowing and willful offer, payment, solicitation, or receipt of any remuneration, in cash or in kind, to induce or in return for referring an individual for the furnishing or arranging of any item or service for which payment may be made under a Federal health care program. Remuneration means anything of value and can include gifts, under-market rent, or payments that are above fair market value for the services provided. Criminal penalties for violation are a fine of up to $25,000 and imprisonment for up to 5 years. 42 U.S.C. § 1320a-7b.

Compliance with the Anti-Kickback Statute is a condition of payment in Federal health care programs. Claims that include items or services resulting from a violation are not payable and may constitute false or fraudulent claims under the False Claims Act. 42 U.S.C. § 1320a-7b.

Under the Civil Monetary Penalties Law, Social Security Act Section 1128A(a)(7), the U.S. Department of Health and Human Services, Office of Inspector General (HHS-OIG) may impose civil penalties for violations of the Anti-Kickback Statute. The penalties are up to $50,000 per violation plus three times the amount of the remuneration. Violation of the Anti-Kickback Statute may also lead to exclusion from Federal health care programs. 42 U.S.C. § 1320a-7a.

The Anti-Kickback Statute provides safe harbors for certain arrangements, such as personal services and rental agreements, investments in ambulatory surgery centers, and payments to bona fide employees. Physicians with questions about the Anti-Kickback Statute and these safe harbor arrangements should consult the regulations and guidance documents available from HHS-OIG. 42 C.F.R. § 1001.952.

Exclusion Provisions

Under Section 1128 of the Social Security Act, HHS-OIG has authority to exclude individuals from participating in Federal health care programs, including Medicaid, for various reasons. Exclusions can be mandatory, meaning HHS-OIG has no choice about whether to exclude, or discretionary, which means the HHS-OIG does have a choice. Exclusion is mandatory for convictions of program-related crimes, convictions related to patient abuse, felony convictions related to health care fraud, and felony convictions related to controlled substances. Exclusion is discretionary for loss of license due to professional competence or financial integrity, convictions related to fraud, convictions related to obstruction of an investigation or audit, misdemeanor convictions related to controlled substances, and participation in prohibited conduct such as kickbacks and false statements. 42 U.S.C. § 1320a-7.

Generally, Federal health care programs will not pay for items or services furnished, ordered, prescribed, or supplied by an excluded individual or entity. 42 C.F.R. § 1001.1901.

Under the Civil Monetary Penalties Law, Social Security Act Section 1128A, HHS-OIG may impose civil monetary penalties of up to $10,000 per item or service claimed while excluded. HHS-OIG may also impose an assessment of up to three times the amount claimed. 42 U.S.C. § 1320a-7a.

¹ While a health care professional who provides services through Medicaid may employ an excluded individual who does not provide any items or services paid for, directly or indirectly, by Federal health care programs, practitioners should exercise caution. A professional who contracts with or employs “a person that the provider knows or should know is excluded by OIG … may be subject to CMP (Civil Monetary Penalty) liability if the excluded person provides services payable, directly or indirectly, by a Federal health care program.” The prohibition is not limited to items or services involving direct patient care, but extends for example to filling prescriptions, providing transportation services, and performing administrative and management services that are not separately billable. See U.S. Department of Health and Human Services, Office of Inspector General, “Updated Special Advisory Bulletin on the Effect of Exclusion From Participation in Federal Health Care Programs,” (May 8, 2013). Available at https://oig.hhs.gov/exclusions/files/sab-05092013.pdf. If, for example, a biller is excluded from a government health care program, payments on claims submitted by the practice through the biller may be considered overpayments subject to recoupment. Any person who has received an overpayment must return the money within 60 days of the date on which the overpayment was identified. Failure to do so may subject the person to liability under the False Claims Act and the Civil Monetary Penalties Law. 42 U.S.C. 1320a-7k.

² It is in the best interest of physicians and other providers to screen potential employees and contractors prior to employment or hiring to ensure they are not excluded from participating in Federal health care programs. In addition, providers should regularly check the exclusions database to ensure that none of the practice’s employees or contractors have been excluded. The Centers for Medicare & Medicaid Services (CMS) has issued guidance to State Medicaid agencies that they should require providers to screen their employees and contractors for exclusions by checking the database on a monthly basis. The guidance further advises States to require all providers to report any exclusion information discovered immediately. The List of Excluded Individuals/Entities (LEIE) database is available at http://exclusions.oig.hhs.gov/ on the HHS-OIG website. Both licensed and unlicensed individuals may be excluded, so it is best to check for both. In addition to checking the LEIE, providers should check the Exclusions Extract, which can be accessed by visiting https://www.sam.gov/ on the System for Award Management website. Centers for Medicare & Medicaid Services, State Medicaid Director Letter 09-001 (p. 4), (Jan. 16, 2009). Available at https://downloads.cms.gov/cmsgov/archived-downloads/SMDL/downloads/SMD011609.pdf.

Civil Monetary Penalties Law

As previously noted, the Civil Monetary Penalties Law, Section 1128A of the Social Security Act, authorizes HHS-OIG to impose civil penalties for violations of the Anti-Kickback Statute as well as a range of other violations. Penalties range from $10,000 to $50,000 per violation. These violations include, but are not limited to, the following:

• Submitting false claims
• Violating Medicare assignment provisions or the physician agreement;
• Providing false or misleading information expected to influence a decision to discharge a patient;
• Failing to provide an adequate medical screening examination for patients who present to a hospital emergency department with an emergency condition or in labor; and
• Making false statements on applications or contracts to participate in a Federal health care program.

42 U.S.C. § 1320a-7a.

3. Categories of FWA

Each suspected case of FWA is reviewed to categorize the allegation as Fraud, Waste, or Abuse. Intent is the key distinction between Fraud and Abuse. An allegation of waste and abuse can escalate into a fraud investigation if a pattern of intent is determined.

Fraud is defined as an intentional deception, false statement, or misrepresentation made by a person with the knowledge that the deception could result in unauthorized benefit to oneself or another person. It includes any act that constitutes fraud under applicable federal or state law. It is a crime to defraud the Federal Government and its programs. 18 U.S.C. § 1001. Punishment may involve imprisonment, significant fines, or both. Criminal penalties for health care fraud reflect the serious harms associated with health care fraud and the need for aggressive and appropriate fraud prevention. In some states, providers and health care organizations may lose their licenses. Convictions also may result in exclusion from participation for a specified length of time. Fraud may also result in civil liability.

Examples of Fraud Could Include:

• Providing false statements on an enrollment application to obtain coverage or concealing information about past medical history/preexisting conditions.
• Using someone else’s ID card or loaning your ID card to someone not entitled to use it.
• Failing to report other insurance or to disclose claims that were a result of a work related injury.
• Billing for services that were not rendered.
• Providing services that are not medically necessary for the purpose of maximizing reimbursement.
• “Upcoding” - billing for a more costly service than was actually provided.
• “Unbundling” - billing each step of a test or procedure as if it were separate instead of billing the test or procedure as a whole.
• Submitting claims with false diagnoses to justify tests, surgeries or other procedures that are not medically necessary.
• Accepting kickbacks for member referrals.

Waste is defined as failure to control costs or regulated payment associated with federal program funding. Furthermore, waste results in taxpayers not receiving reasonable value for their money. Waste relates primarily to mismanagement, inappropriate actions, or inadequate oversight.

Examples of Waste Could Include:

• Poor execution or lack of widespread adoption of best practices, such as effective preventive care practices or patient safety best practices.
• Unnecessary hospital readmissions, avoidable complications, and declines in functional status, especially for the chronically ill.
• Overtreatment.
• Administrative complexity.

Abuse is defined as practices that are inconsistent with professional standards of care; medical necessity; or sound fiscal, business, or medical practices.

Examples of Abuse Could Include:

• Billing for services that were not medically necessary
• Charging excessively for services or supplies
• Coding and billing for 99215 Office or other outpatient visit Evaluation and Management (E/M) for one hour when the visit was actually only 15 minutes.

4. FWA Responsibilities and Activities

Detecting, preventing, and reporting FWA are the responsibilities of everyone associated with the WTC Health Program including employees, members, providers, and contractors.

The WTC Health Program will closely monitor program activities to detect or prevent any FWA. The WTC Health Program will report fraudulent conduct to federal law enforcement agencies and violators may be subject to criminal, civil, or administrative penalties. Information concerning suspected fraud related to the WTC Health Program by contractors, grantees, health care providers, or individual recipients will be reported to the Department of Health and Human Services Office of Inspector General (OIG) by phone at 1-800-HHS-TIPS (1-800-447-8477); online at oig.hhs.gov/report-fraud; or in writing to the following address: U.S. Department of Health and Human Services, Office of Inspector General, ATTN: OIG HOTLINE OPERATIONS, P.O. Box 23489, Washington, DC 20026.

The WTC Health Program has instituted FWA activities including:

• Developing and implementing a WTC Health Program FWA Policy
• Providing FWA education
• Requiring all contractors to develop and implement a FWA policy
  • Clinical Centers of Excellence
  • Data Centers
  • Nationwide Provider Network
  • Health Program Support
  • Pharmacy Benefits Manager
  • Health Program Evaluation
  • Health Insurance Matching Program
• Performing data reviews to detect potential instances of FWA
• Performing FWA audits (internal and external).

The following areas of the WTC Health Program incorporate measures and activities to protect against FWA:

4.1 Member Eligibility and Enrollment

The full application and enrollment process is described in the WTC Health Program Policy and Procedure Manual (PPM, Chapter 2). Using an online portal or by submitting a paper application, applicants apply to the program and submit supporting documentation related to their activities, location, and time periods of exposure. Applications are reviewed for completeness and compliance with the relevant eligibility criteria established in Title XXXIII of the PHS Act and 42 C.F.R. part 88. Quality Control checks are built into the workflow and there is an appeals process for denials of enrollment (see 42 C.F.R. § 88.14). Internal audits of enrollment are conducted on a quarterly basis. Performance metrics are used to monitor the completeness and timeliness of the application/enrollment process, and outreach and communication services. These Quality Control checks facilitate the identification of potential instances of FWA.

4.2 Outreach and Education

Outreach and education materials, including the Member Handbook, incorporate information on member FWA responsibilities, such as avoiding potential fraudulent enrollment. Various Program activities also help to ensure that resources are used efficiently and waste is avoided. The WTC Health Program works strategically with the Responder and Survivor Steering Committees, Clinical Centers of Excellence (CCEs), the Nationwide Provider Network (NPN), and the Data Centers (DCs) to evaluate program participation and client satisfaction. The program seeks to maintain contact with currently enrolled members and to increase participation for those who have been inactive in program follow-up. Together with CCEs, NPN, DCs, and Steering Committees, the WTC Health Program identifies and reduces barriers that affect member participation. The tools employed include surveys, newsletters, websites, key informant feedback, and scheduling reminders.

4.3 Provider Credentialing and Registration

The CCEs/NPN have primary responsibility for safeguarding against fraudulent providers. The CCEs/NPN vary in how they provide medical services; some do most of the services in-house while others refer many services to outside providers. External providers affiliated with the CCEs are credentialed and enrolled in the Program through a third party provider management sub-contractor under a WTC Health Program Support (HPS) contract. This provider management sub-contractor screens CCE-affiliated external providers against the OIG/GSA exclusion lists and/or the CMS Fraud Investigation Database, conducts criminal background checks, establishes business agreements which include a provision that the agreement with the WTC Health Program may be terminated immediately for fraudulent billing, gives guidance to the providers on the limited nature of the WTC Health Program and what costs may be appropriately paid, and informs the network providers of the authorization and billing requirements for member care including the following:

• Referrals from the CCEs are for specific evaluation and care covered by the WTC Health Program;
• Provider bills will be authorized by the CCEs following principles of medical necessity within the limitations set forth by the WTC Health Program;
• Charges will be paid according to billed amounts up to the maximum fee schedule set by the Department of Labor’s Office of Workers Compensation Program (FECA price) or other rate structures approved by the Administrator, with no balance billing of the member;
• Prescribing privileges for providers are individually authorized by the CCEs; and the allowed medications are constrained to the member’s assigned pharmaceutical benefit plan.

External providers affiliated with the NPN are credentialed and enrolled through a separate third party administrator under United Health Care (UHC). NPN authorizes provider bills in the same manner as the CCEs.

Once CCEs/NPN request registration of a provider in the program, the HPS contractor registers the provider in the claims system so that they can be paid. As part of this registration process, the HPS contractor verifies the validity of the provider’s National Provider Identification (NPI) number.

4.4 Health Condition Certification

The WTC Health Program provides a limited health care coverage for qualifying certified WTC-related and medically associated conditions. Treatment benefits are controlled through administrative certification of health conditions on an individual member basis (see PPM Chapter 3 for full details). This process, outlined in Title XXXIII of the PHS Act and in 42 C.F.R. part 88, enables the mandatory requirements for coverage to be determined through a two-step process that first entails a clinical diagnostic evaluation which is subsequently reviewed by a federal official for certification. The process has data quality and control checks built into the workflow, including an administrative appeals procedure (see 42 C.F.R. § 88.21), a decertification procedure (see 42 C.F.R. § 88.19), member communication regarding health condition certification denials, and a procedure for the Administrator’s discretionary reopening of decisions (see 42 C.F.R. § 88.25). The HPS contractor and CCE/NPN exchange certification data to ensure alignment of member information for benefit management. The two-step process consisting of an initial CCE/NPN physician determination, followed by a review and certification by the Administrator or designee provides distinct exercise of independent judgement of the relatedness of the medical diagnosis with exposure information to effect certification of conditions, thus further safeguarding certification against FWA.

4.5 Medical Benefits

The medical benefits available under the program are detailed in Chapter 4 of the PPM. This chapter of the PPM includes FWA mitigation procedures that help prevent unnecessary or unauthorized services being paid under the program.

The WTC Health Program maintains a Code Book of the allowable billing codes by specific benefit plans. The Code Book categorizes the benefit plans for the initial health evaluation, periodic medical monitoring, cancer screening, diagnostic evaluation, and treatment of specific certified conditions (through “care suites”). Further details about benefit control can be found in Chapter 4. There is an administrative medical change control process that ensures oversight for any requested change to the Code Book; and quality control checks are built into the workflow. The Code Book is also subject to modification based on evaluation of reasons for denied service claims, updates to medical guidelines or policy, coding updates from source organizations, and when new health conditions are added for program coverage.

The CCEs, DCs, and NPN must adhere to an operations manual that specifies how they are implementing the tasks in their performance work statement. The elements are addressed in Chapters 6, 7, and 8 of the PPM. These operations include quality assurance metrics for scheduling, completion of all components of the examination and testing, notification and counseling about results and providing professional referrals for further evaluation or treatment compliant with program policy and standards of medical practice.

The WTC Health Program meets with the medical directors and administrators of the CCEs, DCs, and NPN on a regular basis to calibrate and clarify medical and administrative policies and procedures. Minutes of these meetings are taken and sent out to all participants. Practice guidelines following principles of medical necessity and community standards of care are produced by the DCs in consultation with the CCEs and approved for implementation by the WTC Health Program.

4.6 Pharmacy Benefits

Prescription medications are a significant expenditure for member treatment under the WTC Health Program. Significant controls are in place to prevent FWA and ensure that only those drugs in a specific formulary are authorized and paid by the program.

WTC Health Program members receive outpatient medication to control certified conditions and medically associated conditions arising from the 9/11 terror attacks. Members with certified health conditions are assigned a specific pharmacy benefit plan. Each pharmacy benefit plan has a closed formulary, authorization controls for certain medications, and provides the pharmacist with safety messaging and real-time claims processing at the point of sale. Chapter 14 provides details regarding these benefit plans and the formulary change control process that ensures oversight for requested changes to program formularies. The plan formularies undergo periodic review by the Medical Benefits Team. The WTCHP medical and pharmacy teams work with the CCEs and NPN to determine prescribing patterns, medical necessity criteria, safety concerns, and make cost assessments. The pharmacy team analyzes paid claims and conducts on site audits of the CCE’s to ensure prescriptions are used for certified conditions. New drugs and drug requests get reviewed monthly to determine if they should be added to the formulary. The pharmacy team reviews most frequently prescribed medications, brand vs generic, single source brand use, overrides, DEF costs, coordination of benefits for survivors, opioid use, pharmacy overrides such as prior authorizations, prescription not covered, and refill too soon.

4.7 Payment for Healthcare Services

Claims processing and payment is a critical area in the protection against FWA in the WTC Health Program.

The WTC Health Program uses a fee-for-service reimbursement strategy for health care services (see Chapter 5). The only exception is a capitated fee for a group of services constituting the standardized initial health and annual medical monitoring examination for eligible members (see Chapter 4). The WTC Health Program pays the approved rates to an enrolled provider, for covered, correctly coded and correctly billed services, provided to an eligible beneficiary (see 42 C.F.R. § 88.22).

The claims processing system has been designed to guard against FWA by reducing payment errors by preventing the initial payment of claims that do not comply with the WTC Health Program coverage, coding, payment and billing policies. To maintain or improve provider compliance and lower the error rate, the WTC Health Program follows these parallel strategies:

• Support and promote the use of industry-standard electronic claims submission to optimize claims processing efficiency;
• Ensure the integrity of the HPS contractor’s automated claims processing system logic to verify member status, provider status, and the WTC Health Program coverage and medical policies pertaining to assigned benefit plan(s) based on certification of health condition(s);
• Educate the CCEs/NPN about all health care benefit policies and procedures and how these are presented in the WTC Health Program Code Book;
• Apply the software for the CMS National Correct Coding Initiative, the Department of Labor’s Federal Employees Compensation Act (FECA ) fee schedule, and the CMS Inpatient Prospective Payment System to the HPS contractor’s claims processing workflow to ensure correct coding and pricing;
• Apply a contractual policy limitation requiring that claims be submitted within fifteen (15) months of the date of service to qualify for payment (claims involving coordination of benefits must be submitted within 18 months of the date of service);
• Align payment records with CCEs/NPN, and provide electronic remittance advice notices to providers;
• Identify provider noncompliance with coverage, coding, billing, and payment policies through analysis of data (e.g., profiling utilization of services by CCEs/NPN, types of conditions, high cost, high frequency, or other anomalies);
• Correct past improper payments through claims adjustment and CCEs/NPN education;
• Assess and rectify CCEs/NPN authorization practices with respect to improper bill processing (error rate);
• Audit processed claims to ensure accuracy of payments by the automated system;
• Retrospectively recoup funds due from workers’ compensation carrier(s) using a third party Health Insurance Matching Program contractor.

The CCEs, the NPN, and the HPS contractors analyze provider compliance with WTC Health Program coverage and coding rules and take appropriate corrective action when providers are found to be non-compliant. For example, some errors are the result of provider misunderstanding or failure to pay adequate attention to Program policy. Other errors may represent calculated plans to knowingly acquire unwarranted payment. The CCEs/NPN evaluate the circumstances surrounding the errors and proceed with the appropriate plan of correction. If errors continue to be repeated, or if the errors suggest potential fraud or a pattern of abuse, then more severe administrative action is initiated.

The HPS contractor consults with industry experts to identify medical practice and technology changes that may result in improper billing or program abuse to propose areas for data analysis and remedial action as needed. Types of service claims are routinely assessed for patterns of waste or abuse include, but are not limited to:

• Oxygen and other durable medical equipment
• Administration of anesthesia
• Contrast material for imaging studies
• Psychotherapy service intensity
• Modifier codes indicating multiple surgeries on the same day
• Emergency department services
• Evaluation and management service level of intensity.

While automation is the preferred mode of operation for the claims processing system to minimize error from human touch, based on program findings, the following types of claims are routinely handled through manual processing:

• Cancer, emergency room service and professional services associated with inpatient confinement, since these were beyond the original design of the outpatient Code Book;
• Skilled nursing facility and home care service intensity;
• Drug and alcohol rehabilitation service intensity;
• Procedures that do not have an automated fee determined;
• Contradictions in coding associated with point of service, type of bill, procedure, or revenue code;
• Dental claims, since these are processed according to different industry standards and volume is low;
• Prior authorization (Level 3) requirement by WTC Health Program medical staff.

Metrics are monitored that assess electronic claims submission accuracy, claims processing time, auto-adjudication success and accuracy, claims volume and payment adjustments, volume and reasons for claims being denied or pended for further resolution, and compliance with the Prompt Payment Act.

4.8 Payment for Pharmacy Benefits

All points of sale are connected to the program’s contracted pharmacy benefit manager through software transmitting claims processing rules and safety notices to the pharmacist at the point of sale. The rules require verification of member, pharmacy plan assignment, an authorized prescriber, a supply limit and prevent early refills, off-formulary product dispensing, and dispensing of duplicate ingredients or supplies. Higher tier drugs or select products that may be prone to misuse or abuse require additional authorization by the CCE/NPN in the system before the pharmacist can fill the prescription. Prescriptions are filled with generic formulations unless a brand is authorized. Brand availability on the formulary is subject to considerations of therapeutic efficacy, allergy to ingredients, side effect profile, patient adherence factors, safety, and cost. Continual monitoring to optimize pharmacy cost control strategies include the following:

• Assignment of certain preferred brands to negotiate price/rebate with manufacturer;
• Consistent pricing agreements, including maximum allowable cost, among participating retail chains for brand and generics;
• Improved pricing for mail order pharmacy arrangement on generics;
• Selecting preferred specialty pharmacy for compound medications to control price and quality control;
• Step therapy for medications;
• Split dispensing strategies to ensure effectiveness and side effect tolerance for oral anti-neoplastics;
• Timely alignment of prescribing controls to match shifts in marketing (generic availability and more cost effective over-the-counter preparations);
• Services for drug utilization analyses, pharmacy audits, and provider record audits for policy compliance.

4.9 Recoupment Activities

The following administrative improvements enhance controls for FWA. Title XXXIII of the PHS Act requires recoupment of treatment costs for WTC-related health conditions and medically associated health conditions if the condition is work-related (see also 42 C.F.R. § 88.24). The WTC Health Program determined that the CCEs and NPN did not have the resources to manage this requirement, so an alternative approach was implemented that utilizes the New York State Workers’ Compensation Board Health Insurance Match Program (HIMP) that assists health insurers and health benefits plans to set up a system to identify claims that they have paid which may be the responsibility of the employer, workers' compensation insurance carrier, or special fund, and to obtain reimbursement therefore. The WTC Health Program awarded a contract to HMS Federal to implement the HIMP for our program in September, 2014. The WTC Health Program receives monthly reports on recoupment activities. Since HIMP is a comprehensive and efficient process that interacts directly with the New York State Workers’ Compensation Board and insurers, more funds are recovered and verification of appropriate claims payment is increased.

4.10 Program Performance

The WTC Health Program has created an online set of policies and procedures for transparency and consistency in program administration. In addition to this PPM chapter on FWA, there are requirements for the Health Insurance Portability and Accountability Act (HIPAA) and the Federal Information Security Management Act (FISMA).

Working with the HHS Program Integrity Initiative, the WTC Health Program is addressing data security and privacy (HIPAA and FISMA), resource alignment for performance requirements of CCEs/NPN to comply with benefit administration, streamlining the process of program application/processing, and program communication. In addition, the WTC Health Program periodically reviews metrics that provide qualitative and quantitative measures to assess the Program’s performance on customer service, pharmacy utilization, claims processing, and cost efficiency of managing the WTC Health Program. Review of these metrics facilitates the identification of potential instances of FWA.

5. FWA Allegation Investigation and Resolution Procedure

The WTC Health Program has a Fraud Prevention Officer (FPO) and a Fraud Risk Assessment Team (FRAT) in place who adhere to established procedures for processing allegations pertaining to FWA when received. The FRAT includes the FPO, the WTC Health Program Deputy Division Director, the Office of the General Counsel (OGC), and any other relevant parties related to the specific allegation. The WTC Health Program provides stakeholders with information about the Program’s FWA efforts and procedures through information included on the WTC Health Program website and in the Member Handbook. Allegations of FWA are to be reported to the FPO. In addition, the HHS OIG has a website dedicated to reporting possible FWA. (http://oig.hhs.gov/fraud/report-fraud/index.asp)

If the allegation of FWA comes to the WTC Health Program from the OIG, the FPO will work with the OIG, as requested, to assist with the OIG investigation. When an allegation of FWA is received from any source other than the OIG by the WTC Health Program, the allegation is immediately forwarded to the FPO. The FPO will record receipt of the allegation on the FWA Intake Form, enter the FWA allegation into the FWA Allegation Status Log, and begin an initial investigation to determine if the allegation should be categorized as fraud, waste, or abuse.

As a result of the initial investigation, if the allegation is categorized as potential fraud, the FPO will gather any relevant information and forward the case to the OIG for investigation. The FPO will monitor the status of the OIG investigation and report the OIG’s findings and resolution to the FRAT.

If the allegation is determined to be either waste or abuse, the FPO will continue the WTC Health Program’s internal investigation of the allegation with the assistance of any relevant personnel. Once the investigation is completed, the FPO will present the results of the investigation to the FRAT along with a recommended resolution. The FPO is responsible for ensuring the waste or abuse allegation is resolved based on the decision of the FRAT. The FPO is also responsible for ensuring the waste or abuse investigation and resolution are documented and reported to the appropriate HHS/CDC contact, as required.

Pharmacy Benefits

Chapter 10 - Reserved

Chaper 11 - Governmental Affairs

1. Purpose and Scope

The purpose of this chapter is to describe the relationships and actions among the World Trade Center (WTC) Health Program, other parts of the National Institute for Occupational Safety and Health (NIOSH), the Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), and other government agencies. The WTC Health Program is responsible for providing health care benefits according to the provisions of the Zadroga Act, including those provisions related to WTC Health Program member eligibility, enrollment, benefits, and responsibility for determining the payment amounts to be disbursed. The Administrator, Centers for Medicare & Medicaid Services (CMS), is responsible for disbursing payment for the program. Administration of the WTC Health Program involves cooperation and coordination with HHS and other government agencies, some of which are specified in the Zadroga Act. The WTC Health Program must also cooperate with, and respond to, program oversight evaluations and audits performed by the Government Accountability Office (GAO) and HHS Office of the Inspector General (IG). In addition, the WTC Health Program collaborates with other 9/11 programs such as the September 11th Victim Compensation Fund (VCF) administered by the Department of Justice.

2. Oversight and Counsel

1. Department of Health and Human Services
   1. Office of the Inspector General (IG) (The Zadroga Act, 42 U.S.C. § 300mm(d))

      Responsibility: The Zadroga Act requires the HHS Office of the Inspector General (IG) to manage certain oversight responsibilities, including the review of the WTC Health Program health care expenditures to detect fraudulent or duplicate billing and payment for inappropriate services, as well as the review of the WTC Health Program for unreasonable administrative costs, including with respect to infrastructure, administration and claims processing. In addition, the IG can initiate a review, not specifically required by the Zadroga Act, of other components of the WTC Health Program.

      Activity: In August 2011, the HHS IG initiated an audit to review the WTC Health Program’s controls for awarding and monitoring the Clinical Centers of Excellence (CCEs) and determine whether the CCEs’ financial systems can provide reliable financial and performance data, including medical service claims data. As of July 2013, the results of this review had not yet been published.

   2. Office of the General Counsel (OGC)

      The Office of the General Counsel (OGC) provides representation and legal advice for the Department of Health and Human Services (HHS). OGC supports the development and implementation of the Department's programs by providing legal services to the Secretary of HHS and the organization's various agencies and divisions. OGC provides legal support and assistance to the WTC Health Program to ensure the Program is administered in accordance with the Zadroga Act and other applicable Federal laws and regulations.

2. Government Accountability Office (GAO) (Exhibit 1, 42 U.S.C. § 300mm-4 and § 300mm-22)

   Responsibility: The Zadroga Act required the Comptroller General to submit an analysis to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate no later than July 1, 2011 on whether the Centers for Clinical Excellence (CCEs) have financial systems that allow for the timely submission of claims data (Exhibit 1, 42 U.S.C. § 300mm-4(d)). In addition, the Zadroga Act requires the GAO to study feasibility, efficiency and effectiveness issues related to the WTC Health Program, including:

   1. The feasibility of the WTC Health Program using one consolidated data center rather than multiple data centers (Exhibit 1, 42 U.S.C. § 300mm-4(a)(5));
   2. Whether the Department of Veterans Affairs (VA) can provide monitoring and treatment services to WTC Health Program members outside the New York metropolitan area more efficiently and effectively than the nationwide provider network (Exhibit 1, 42 U.S.C. § 300mm-23(d)(2));
   3. Whether use of an existing federal prescription drug purchasing program would provide member prescription drugs benefits more efficiently and effectively than through the WTC Health Program (Exhibit 1, 42 U.S.C. § 300mm-22(c)(1)(B)(iv)).

   The GAO, like the IG, can also initiate a review, not specifically required by the Zadroga Act, of other components of the WTC Health Program.

   Activity: The Zadroga Act required GAO to report by July 1, 2011, on whether the CCEs under contract with the WTC Program Administrator had financial systems that would allow for the timely submission of health care claims data as envisioned by the act. According to the WTC Program Administrator’s CCE contract awards schedule, the Administrator would not have awarded any contracts with the CCEs until at least June 30, 2011. Therefore, they could not perform a review of CCE contractors’ financial systems because no CCE contractors were in place to assess by July 1, 2011. On July 15, 2011, GAO issued a briefing that focused on (1) the CDC/NIOSH schedule for awarding contracts to the CCEs, (2) health care claims data for the CCEs and planned procedures, and (3) the Administrator’s plans for evaluating each CCE system’s health care claims data capabilities during and after the award of the contracts. (Exhibit 3)

   The results of the briefing found that:

   1. Schedule for awarding contracts to the CCEs
      • At the time of review, CDC/NIOSH officials were pursuing a CCE contract awards schedule driven by the Zadroga Act’s implementation date of July 1, 2011, and anticipated awarding multiple cost-plus, fixed-free contracts for the CCEs on June 30, 2011.
      • As of June 21, 2011, all acquisition milestone dates had been met and subsequent to the GAO briefing, CDC awarded seven CCE contracts on July 1, 2011.
   2. Health Care claims data for the CCEs and planned procedures
      • The WTC Program Administrator plans to develop program-wide procedures to be used by the CCEs for collecting and reporting of health care claims data after the program is implemented and the CCEs begin submitting health care claims for payment.
      • CCEs will be expected to use the CMS 1500 form, or a similar form, to collect the needed health care claims data.
      • CCEs will be expected to electronically submit, within specified timeframes, all valid health care claims for payment. Each CCE is required to implement a quality assurance program that includes a review of all health claims forms for completeness and accuracy before the claims are submitted.
   3. Administrator’s plans for evaluating each CCE system’s health care claims data capabilities
      • The compressed CCE contract awards schedule could not accommodate site visits by NIOSH personnel or personnel from an outside entity, such as the Defense Contract Audit Agency (DCAA), to assess potential CCEs’ financial systems’ health care claims data capabilities.
      • NIOSH officials may consider having DCAA assess the CCEs’ financial systems after the contracts are awarded.
      • The WTC Program Administrator plans to establish procedures to randomly monitor and/or periodically inspect a CCE’s compliance with the timely submission of health care claims data as part of assessing a CCE’s contract performance.

   On August 4, 2011, GAO issued its report regarding (1) the consolidated data center, (2) the use of VA health care facilities for members living outside the New York metropolitan area, and (3) the use of an existing federal prescription drug purchasing program. (Exhibit 2) While the GAO report did not offer any formal recommendations, its analysis stated that:

   1. Consolidated data center
      • A consolidated data center could lead to cost savings and enhanced research opportunities; however, consolidation could require upfront expenditures.
      • A consolidated data center could result in loss of responders’ clinical data from the WTC Health Program because of the potential need to have responders sign new consent forms to enable use of their data for research.
   2. Use of VA health care facilities
      • Use of VA facilities for the WTC Health Program could affect access to health services for members because not all types of clinical expertise are available at all VA facilities, VA facilities do not always have space available to serve nonveterans, and it would take an undetermined length of time to implement an agreement between VA and HHS.
      • Use of VA facilities for the WTC Health Program could affect retention for a number of reasons because WTC Health Program members might need to change health care providers. For example, members may be required to receive medical care from a particular physician who the member does not wish to see.
   3. Use of an existing federal prescription drug purchasing program
      • Use of an existing federal prescription drug purchasing program to provide prescriptions to WTC Health Program members could reduce drug prices. It might also affect the availability of options for filling prescriptions and members’ access to certain prescription drugs, such as the administration of the generic over brand -name versions of a particular drug.
      • Use of drug purchasing programs, such as those of the VA and the Department of Defense, for WTC Health Program members would require administrative changes to their programs.

   In April 2013, the GAO began working on an audit regarding the addition of cancer to the list of WTC-covered conditions (Exhibit 4). As of July 2013, the report is not yet available. However, the main objectives of this audit are:

   1. To determine the extent to which the methodology used by the WTC Program Administrator for adding certain cancers to the program’s list of covered conditions is comprehensive and balanced
   2. To determine the extent to which the scientific and medical evidence used to support expansion of the WTC Health Program’s list of covered conditions suggests that the cancers added to the program may result from an exposure to the 9/11 attacks
   3. To determine the potential effects of coverage additions on the WTC Health Program and the September 11th Victim Compensation Fund

   3. Grants and Contract Management

   1. Department of Health and Human Services
      1. Centers for Disease Control and Prevention (CDC)
         1. Office of the Director

            The Director of CDC oversees CDC/NIOSH responsibilities under the WTC Health Program. CDC Office of the Director staff, as well as other CDC Offices as appropriate, are involved in reviewing performance plans, documenting progress, identifying risks, and interceding as necessary to ensure the highest standards of performance.

         2. Procurement and Grants Office (PGO)

            The CDC Procurement and Grants Office provides assistance with acquisitionand related activities to enable the centers, institutes, and offices at CDC to implement health-related programs, initiatives, and acquisitions. PGO is the only entity within CDC which can obligate federal funds. PGO contributes to the implementation of initiatives and acquisitions related to the WTC Health Program through non-programmatic management for all Program financial assistance (grants and cooperative agreements) and contract activities.

         3. National Institute for Occupational Safety and Health (NIOSH)
            1. Office of Extramural Programs (OEP)

               The NIOSH Office of Extramural Programs (OEP) facilitates the management of extramural grant and cooperative agreement portfolios. OEP is located within the NIOSH Office of the Director under the direction of the Associate Director for Research Integration and Extramural Performance. OEP manages the extramural portfolio of cooperative agreements for all NIOSH activities, including the WTC Health Program. OEP, in coordination with the WTC Health Program, facilitates the solicitation, review, and issuance of cooperative agreements related to the September 11th terrorist attacks. This portfolio includes the awards for the WTC Health Registry, research projects, and outreach and education activities (Exhibit 1, 42 U.S.C. §§ 300mm-2, 300mm-51, 300mm-52).

   4. Eligibility and Enrollment

   1. Department of Health and Human Services (HHS)
      1. Centers for Disease Control and Prevention (CDC) and National Institute for Occupational Safety and Health (NIOSH)

         Responsibility: The Secretary of HHS delegated authority to the WTC Health Program to assume enrollment and eligibility functions (Exhibit 5). Required eligibility and enrollment activities that were delegated under the Zadroga Act include:

         • Establishing and conducting a procedure to enroll individuals who meet eligibility requirements as WTC responders or survivors (42 U.S.C. §§ 300mm-21(a)(3)(A), 300mm-31(a)(1)(C)(i));
         • Screening applicants prior to enrollment against the terrorist watch list (42 U.S.C. §§ 300mm-21(a)(5), 300mm-31(a)(4)) (see next section, b. (Department of Homeland Security (DHS)/Department of Justice (DOJ)); and
         • Setting up an appropriate appeal process for applicants denied enrollment (42 U.S.C. §§ 300mm-21(a)(3)(A)(vi), 300mm-31(a)(1)(C)(i)(IV));

         Activity: The procedures and protocols used to perform WTC Health Program eligibility and enrollment functions are detailed in Chapter 2, Eligibility and Enrollment. The procedures and protocols used to perform Program oversight are detailed in Chapter 12, Quality Assurance and Program Evaluation.

   2. Department of Homeland Security (DHS)/Department of Justice (DOJ) ( 42 U.S.C. §§ 300mm-21(a)(5), 300mm-31(a)(4))
      

      Responsibility: The Zadroga Act mandates that any individual who is on the terrorist watch list maintained by the Department of Homeland Security (DHS) be disqualified for eligibility within the WTC Health Program. The Zadroga Act incorrectly states that DHS maintains the terrorist watch list. The Federal Bureau of Investigation (FBI), housed within the Department of Justice (DOJ), administers the Terrorist Screening Center (TSC). As such, the WTC Program Administrator collaborates with the TSC to meet the requirements of the Zadroga Act regarding qualification for enrollment in the WTC Health Program.

      Activity: The WTC Health Program established a process to share WTC Health Program member and applicant information with DOJ in order to meet the requirements of the Zadroga Act. The WTC Health Program Contractor prepares a list of new WTC Health Program applicants on a weekly basis and the list is transferred to the TSC. Based on the information provided by the TSC, the applicant is qualified or not qualified for enrollment into the WTC Health Program. Only qualified applicants will be considered for enrollment into the WTC Health Program based on the Program’s eligibility criteria. (See Chapter 2, Eligibility and Enrollment)

   5. Payment

   1. Centers for Medicare and Medicaid Services (CMS)

      Responsibility: The Zadroga Act prohibits NIOSH from making payments for the provision of WTC Health Program health care benefits (Exhibit 1, 42 U.S.C. § 300mm-5(14)(B)).

      Activity: The Secretary, HHS, delegated authority for disbursing payments in the WTC Health Program to the Administrator, Centers for Medicare & Medicaid Services (CMS) in May 2011. (Exhibit 5, 76 Fed. Reg. 31337 (May 31, 2011)). The WTC Health Program and CMS established an interagency agreement for this activity. See Chapter 5, Claims Processing, for details regarding the CMS payment function.

   2. Department of Labor (DOL) (Exhibit 1, 42 U.S.C. § 300mm-22(c)(1)(A))

      Responsibility: As required by the Zadroga Act, the WTC Health program reimburses costs for medically necessary treatment for WTC-related health conditions according to the payment rates that would apply to the provision of such treatment and services by the facility under the Federal Employees Compensation Act (FECA). For treatment for which FECA rates are not available, the WTC Health Program administrator is required to establish a treatment reimbursement rate (Exhibit 6, 42 C.F.R. § 88.16). In no case are the payments for WTC Health Program products or services made at a rate higher than the Office of Worker’s Compensation Programs (OWCP) in DOL would pay for such products or services rendered at the time such products or services were provided.

      Activity: The WTC Health Program consulted with DOL to determine the best policies and procedures to reimburse for the provision of health care under the WTC Health Program. Based on those policies and procedures, the WTC Health Program established a system to process WTC Health Program claims, ensuring claims are paid in accordance with the Zadroga Act. In addition to establishing audits to ensure compliance, the WTC Health Program performs periodic retrospective reviews and analyses of claims to audit the Program’s performance. More detailed information regarding claims processing can be found in Chapter 5.

   6. Other 9/11- Related Programs

   1. Department of Justice (DOJ) September 11th Victim Compensation Fund (VCF) (Exhibit 1, 49 U.S.C. § 40101 note)

      Responsibility: Title II of the Zadroga Act reactivates the September 11th Victim Compensation Fund of 2001 (VCF) that operated from 2001-2004 and requires a Special Master, appointed by the Attorney General, to provide compensation for any individual (or a personal representative of a deceased individual) who suffered physical harm or was killed as a result of the terrorist-related aircraft crashes of September 11, 2001 or the debris removal efforts that took place in the immediate aftermath of those crashes. On August 31, 2011, DOJ published a Final Rule regarding the operation of the VCF, as revised by the Zadroga Act, in the Federal Register (76 Fed. Reg. 54112).

      The VCF only provides compensation for losses due to personal physical injury or death. An individual who elects compensation from the VCF waives his or her rights to pursue litigation to seek damages for the physical injury or death resulting from the September 11, 2001 attacks.

      Activity: The WTC Health Program assists DOJ as outlined by a Memorandum of Understanding (MOU) between the VCF and the WTC Health Program. With the specific authorization and consent of an individual VCF claimant, the MOU facilitates: 1) for those VCF claimants participating in both the WTC Health Program and the VCF, transmission of the individual’s WTC Health Program medical information, including the WTC Health Program’s decisions regarding certification and authorization for treatment, to the VCF for purposes of facilitating the VCF’s evaluation of the individual’s VCF claims; and 2) for those VCF claimants who do not receive care within the WTC Health Program, review by the WTC Health Program of VCF claimants’ exposure and health information to assist the VCF, for the purposes of making compensation determination, in verifying whether claimants’ health conditions are related to their 9/11 exposures.

   
   
   

   Appendices

   Appendix 11-1: The James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act)
   
   Appendix 11-2: GAO-11-735R, World Trade Center Health Program: Potential Effects of Implementation Options, August 4, 2011
   
   Appendix 11-3: GAO-11-793R, World Trade Center Health Program: Administrator’s Plans for Evaluating Clinics’ Capabilities to Provide Required Data, July 15, 2011
   
   Appendix11- 4: GAO Engagement #291133: The World Trade Center Health Program, April 19, 2013
   
   Appendix11- 5: “Public Health Service Act (PHS); Delegation of Authority,” 76 Fed. Reg. 13371, (May 31, 2011)
   
   Appendix 11-6: “WTC Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions, and Reimbursement
   
   

Chapter 12- Financial Management Quality Assurance Standards

1. Introduction

The financial management quality assurance standards plan is designed to create the framework for achieving and maintaining financial management control and performance standards in the World Trade Center (WTC) Health Program. A well-executed quality assurance standards program creates awareness of performance standards and emphasizes policies and procedures, controls, performance management, performance measurement, efficiency, and guidance measures to prevent waste, fraud, and abuse. In addition, good quality assurance standards provide reasonable assurance that a program’s goals and objectives will be achieved.

2. Purpose

The purpose of this guidance is to create a framework for WTC Health Program financial controls, performance management, and performance measurement. This framework includes five focus areas relevant to financial controls, performance management, and performance measurement. The five focus areas are as follows:

Focus Areas	Scope	Measure
Fund Control Management	Provide reasonable assurance that funding requirements adhere to Appropriations Law, U.S. Department of Health and Human Services (HHS) guidelines, James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act) and James Zadroga 9/11 Health and Compensation Reauthorization Act (Reauthorization) requirements and intent, and prevent fraud, waste, and abuse	100% compliance with Appropriations Law, HHS guidelines, and Zadroga Act and Reauthorization requirements.
Spend Plan Development and Management	Coordinate the planning and development of Spend Plans with appropriate staff. Review prior fiscal year(s) actual results; assess impact of known program and budget issues/decisions; and set priorities based on Program’s goals and mission.	Spend Plan developed and submitted to Office and Management and Budget (OMB) for approval 30 days prior to new fiscal year.
Budget Execution and Performance	Track, monitor, and report on use of Spend Plan funds; and track, monitor, and report on Program performance (i.e., Clinical Center of Excellence (CCE) and Nationwide Provider Network (NPN) claims submission and contract invoice submissions).	1.) Review, approve, and process CCE and NPN invoices within 5 business days of receipt; and 2.) Review and monitor expenditure trends and produce monthly reports.
Analysis and Budget Forecasting	Conduct regular burn rate reviews of expenditures to determine if current budgets are adequate for balance of performance period.	Establish notification triggers at 75% and 90% expenditure levels and assess the details at each level to determine if Program action(s) is required.
Quality Assurance	Quality assurance encompasses all of the above activities and enables the Program to achieve and maintain high performance levels. Our goals are to develop Standard Operating Procedures (SOPs) for each step of the invoice reimbursement process and closely monitor other performance measures to ensure Program is performing according to statutory requirements.	No deviation from Program’s goals without Core Management Team (CMT) approval.

3. Policy Guidance

The WTC Health Program financial controls and policy and procedures guidance was developed to assist Program and financial management in accomplishing fiscal year fund control objectives. This guidance provides fund control procedures and contract clauses for applicable activities for each fiscal year.

The WTC Health Program works with its contractors, the CCEs and the NPN, to provide quality care to WTC Health Program members. As the Federal entity, the WTC Health Program’s governing role is to ensure that the resources dedicated are properly managed and performance is measured against the Program’s goals and mission to improve financial efficiency.

Procedural Guidance

Steps	Description	Responsibility
1.	Statutory Authority: Title I of the Zadroga Act amended the Public Health Service Act to add Title XXXIII and established the WTC Health Program within the HHS. In December 2015, Title XXXIII of the Public Health Act was amended by the Reauthorization. The Reauthorization authorized the WTC Health Program through FY 2090.
2.	Fiscal Year Spend Plan/Apportionment: Each Fiscal Year’s Spend plan requires the approval of OMB before execution.	Centers for Disease Control and Prevention (CDC)/National Institute for Occupational Safety and Health (NIOSH)/WTC Health Program
3.	Awards: Once the Spend Plan is approved by OMB, the Grants Management Officer (GMO) and Contracting Officer (CO) can begin the process of issuing awards.	OFR/WTC Health Program
4.	Personnel: Personnel projections are based on program priorities and are also subject to the availability of funds.	NIOSH/WTC Health Program
5.	Governance: NIOSH is the responsible Federal entity and must exercise sound stewardship of appropriated funds.	NIOSH/WTC Health Program/OFR
6.	Performance: The WTC Health Program’s overall performance is measured by how effectively and efficiently the Zadroga Act’s and Reauthorization’s requirements were executed.	NIOSH/WTC Health Program
7.	Reports: The Zadroga Act requires the WTC Health Program to submit annual reports to Congress. OMB requires monthly report submissions.	NIOSH/WTC Health Program
8.	Close out: All awards must be closed out at the end of their performance period.	NIOSH/WTC Health Program

Chapter 14 -Pharmacy Benefits

1. Purpose and Scope

This chapter describes the pharmacy benefits that are available through the WTC Health Program under the James Zadroga 9/11 Health and Compensation Act of 2010 (the Act), the types of pharmacy benefits provided, rules regarding adjudication of pharmacy claims, formularies of medications available, the process for requesting changes to the formularies and requesting overrides for uncovered medications, and the risk mitigation processes in place to ensure controls on fraud, waste, and abuse.

2. Statutory and Regulatory References

The following sections of the Act are applicable to this chapter:

1. Section 3312(b)(1)(A)(ii) states that the WTC Health Program will pay for medically necessary treatment for WTC-related health conditions;
2. Section 3312(b)(3) relates to medical necessity for healthcare services, including the scope of treatment, appeals of decisions regarding medical necessity, and the provision of treatment pending certification;
3. Section 3321(b) provides for initial health evaluations (screening) for eligible WTC survivors; and
4. Section 3322 allows for monitoring and treatment of certified-eligible WTC survivors.

Program regulations pertaining to pharmacy benefits are established in the following sections of 42 C.F.R. Part 88:

1. Section 88.1 Definitions;
2. Section 88.20 Authorization of treatment; and
3. Section 88.22 Reimbursement for medical treatment and services.

3. Responsibilities

The parties involved in providing WTC Health Program pharmacy benefits and their responsibilities are detailed below:

1. The Clinical Centers of Excellence (CCEs) and Nationwide Provider Network (NPN) provide medical services and write and approve prescriptions for eligible WTC Health Program member. The CCEs and NPN provide certain prior authorizations (PAs) and perform overrides of system edits, when necessary, for certain medications.
2. The Pharmacy Benefit Manager (PBM) is responsible for receiving, adjudicating, and processing payment of claims for pharmacy benefits. The PBM also processes requests for prior authorizations and overrides, and provides technical assistance for formulary change control.
3. The Health Program Support (HPS) contractor’s pharmacy team receives requests for medications to be added to the formulary, tracks the status of the requests, assembles and communicates the requests to the WTC Health Program medical team in an orderly fashion for decision, and updates the corresponding formularies with the approved medications.
4. The Administrator of the WTC Health Program or designee establishes pharmacy policies for the program, authorizes requests for certain levels of prior authorization, and processes appeals of medication requests denied as not being medically necessary.

4. Benefit Plans

The WTC Health Program assigns members to the appropriate Pharmacy Benefit Plan(s) based on the members’ certified categories of health conditions and membership type (i.e., responder, screening-eligible survivor, certified-eligible survivor, or immediate family of deceased FDNY firefighters). The table below summarizes the current Pharmacy Benefit Plans and provides highlights regarding plan eligibility criteria, indicators of formulary content, and plan use limitations.

Pharmacy Benefit Plan Name	Eligibility Criteria for Plan	Formulary Content	Special Criteria
Diagnostic	All members except FDNY family member, regardless of certification status	Includes Inhalers Antibiotics Proton pump inhibitors H2 blockers Saline wash Medications for diagnosis, screening and pain management of cancer (Generic only except where only Brand is available)	30 day supply limit per fill; maximum supply = 90 days Restricted to: Diagnostic evaluation for a WTC-related condition in a member meeting appropriate 9/11 exposure criteria; Diagnostic evaluation for a condition medically associated with a condition certified as a WTC-related condition in a given member; Preparation for an approved cancer screening benefit (e.g., colon or breast cancer); or Continuity of medically necessary care for a covered condition that the CCE has properly submitted to the WTC Health Program as a request for certification
Standard Treatment	Members with at least 1 certified health condition (Survivor, Responder; not FDNY Family)	Includes medications for the treatment of aerodigestive, musculoskeletal, and mental health conditions	Certain cardiovascular meds, immunosuppressants, anticoagulants and other special meds (e.g., Xolair, methotrexate) require a PA by either the CCE/NPN, or the WTC Health Program pharmacy team.
FDNY Family Mental Health	FDNY immediate family member	Subset of medications in the standard treatment plan for certified mental health conditions	If the member has no mental health condition certification, default to no pharmacy benefit
Transplant	Members with a certified condition and post-organ transplant	Includes standard treatment and transplant formularies to cover the range of potential complications involved	Member must be certified for a disease that led to organ transplantation.
Cancer Treatment	Members who are certified for cancer	Anti-neoplastic and support medications (e.g., those for pain, gastrointestinal, skin, psychiatric, and cardiac conditions) – correlating to the NCCN Compendium http://www.nccn.org/professionals/drug_compendium/content/contents.asp as well as expert input	Medication used for cancer-associated conditions are filled with a 30-day starter dose unless that patient has used them within the last 150 days prior to the needed fill

All Program-approved pharmaceuticals are included in the WTC Health Program formulary (Codebook Volume C), which is grouped by plan and includes an alphabetic and drug class listing for ease of use The Mental Health benefit plan is a subset of the full Standard Treatment benefit plan (STx). Mental Health medications are listed separately to convey the limits of the pharmacy benefit available to the immediate family members of deceased FDNY firefighters.. The Cancer Treatment Pharmacy Benefit Plan includes all medications needed for the routine treatment of cancer as well as cancer conditions Not all are reflected on the formulary list as the list would then be too large to be captured in a single volume..

5. Pharmacy Benefits

1. Pharmacy Benefit Manager (PBM)

   The PBM receives claims from the pharmacies, applies adjudication rules according to standards developed by the WTC Health Program, and compiles and communicates payment and denial data. The WTC Health Program resolves rejected claims via telephone calls with the PBM staff.

   Pharmacy claims are submitted electronically by the pharmacies to the PBM and are then sent to the HPS contractor weekly for processing. The HPS contractor forwards a file to the payment contractor, who issues disbursements to the PBM. The PBM sends the payments to the pharmacies.

   1. Prescription drugs are approved at the point-of-sale (POS) through submission and adjudication of claims at the pharmacy. Members provide their WTC Health Program coverage information to the pharmacy, which validates enrollment through the PBM.
   2. If the prescription is rejected at the POS, the rejection may be overridden by the CCE/NPN directly or by the HPS contractor’s pharmacy team (after consultation with the CCE/NPN). Inquiries regarding rejected prescriptions are received via the WTC Health Program’s call center, which either resolves the reason for the rejection or routes the issue to the Member Services Team for resolution.
   3. The WTC Health Program’s pharmacy network is open, and participating pharmacies across the country may submit a claim to the Program.
   4. The providers who are permitted to prescribe are those who have been authorized by the CCEs or are in the NPN.
   5. Prescription drugs may also be provided through mail-order. The member must register and can do so at the mail-order provider’s website online, via telephone, or through the CCE/NPN. Once the member is registered, the prescriber can e-prescribe, fax, or mail the prescription to the mail-order provider. Mail-order is generally used for maintenance medications only, which can be provided in a 90-day supply with refills. Refills may also be obtained online or by phone, and members may elect to auto-refill.
   6. Pharmacy claims must be submitted within 180 days of the fill date. Older claims must have prior authorization in order to help prevent untimely filing of claims.
   7. Members with certified cancer(s) are likely to receive their care through extended care networks (affiliated with but separate from the CCE or NPN); therefore, the WTC Health Program broadly expanded the therapeutic classes available in the Cancer Pharmacy Benefit Plan, opened the prescriber network, and removed prior authorization restrictions. The WTC Health Program discontinued the assignment of the more extensive Cancer Pharmacy Benefit Plan for the following categories of members: (a) members who have uncomplicated non-melanoma skin and/or thyroid cancer, but no other cancers; and (b) members whose certified cancer(s) is (are) in a stage of remission. Medications for the treatment of certified and uncomplicated cases of non-melanoma skin and thyroid cancers have been added to the Standard Treatment Pharmacy Benefit Plan (Appendix 14-A). With this modification, applicable members are moved from the Cancer Pharmacy Benefit Plan to the Standard Treatment Pharmacy Benefit Plan.
      
      Additionally, each CCE identifies members whose certified cancers are determined to be in remission and uses the Cancer Status Form (CSF) (Appendix 14-B) to notify the WTC Health Program of the change. CCEs will also use the CSF to notify the WTC Health Program of a recurrence or re-emergence of a member’s certified cancer. CCEs are not required to use the CSF when a member’s non-melanoma skin cancer and/or thyroid cancer have gone into remission, as these members are automatically moved to the Standard Treatment Pharmacy Benefit Plan. The NPN completes prior authorizations for all medications for cancer patients and therefore has no need to do a retrospective review. NPN members with a certified cancer in full remission are assigned to the Standard Treatment Pharmacy Benefit Plan if they have other certified conditions, or in the Diagnostic Pharmacy Benefit Plan if they have no other certified conditions.
   
   
2. Adjudication Rules

   The adjudication rules for the PBM are outlined in the tables below:

   Setting	Rule	Comments
   System Settings	Drug Utilization Review Edits- DUR checks are performed on the following: Allergy Screening Drug-Drug Interaction Screening Drug-Diagnosis Caution Screening Drug-Inferred Health State Screening Dosing/Duration Screening Drug-Age Caution Screening Drug-Sex Caution Screening Duplicate Rx Screening Duplicate Therapy Screening Refill Too Soon - This edit is triggered for a claim from the same NCPDP ID & same RX number. The claim will reject if 75% of the previous fill has not been exhausted. Ingredient Duplication –Reject Day Supply Limit 30-day supply limit for Retail 90-day supply limit for Mail Order Drug Limitations (Quantity Limitations) Erectile Dysfunction (ED) Drugs: ED medications will be limited to 6 tablets per 30 days for high dose ED drugs and 30 for 30 days for low dose formulations. No concurrent use of 2 or more ED drugs at the same time.
   Member Eligibility	Eligibility and Member plans are maintained by the PBM The pharmacy is required to send the Member’s ID, Date of Birth, Relationship code, & sex to the PBM. Eligibility search is performed by carrier code and matching member record. When a match is found, the claim will adjudicate. If a match is not found the claim will reject. Secondary claims will reject for Responders. Survivors will pay as secondary claims for those with insurance.
   Per Rx Claim Cost	$1,000 limit at Retail; prescriptions exceeding the $1,000 maximum claim dollar amount will reject. No limit at Mail Order	Per RX
   Compounds	Multiple ingredient compounds are reimbursed under the program, when indicated	compounds
   Drug Coverage	Drug coverage is managed by closed formularies. Drugs on the Standard Treatment, Cancer, and Diagnostic Formularies are payable.	drug cvg
   Dosage Forms	All dosage forms and strengths of formulary products are covered with the exception of bulk powders or liquids due to their cost and minimal use in the Program.
   Prior Authorization	Specific medications on the Standard Treatment Formulary require a Prior Authorization (PA)/override in order to achieve “paid” status. Drug classes requiring Prior Authorization include: Oral antifungals Testosterone replacement agents Erectile dysfunction Antiemetics Antipsychotics ADHD agents Narcotics NSAIDs Migraine agents Anticonvulsants Topical corticosteroids
   Pharmacies Covered	All
   Prescribing Physicians	All

   6. Controlled Substances

   A prescription for a controlled substance may only be issued by a registered practitioner who is 1) authorized to prescribe controlled substances by the jurisdiction in which s/he is licensed to practice and registered with the Drug Enforcement Administration (DEA); or 2) an agent or employee of a hospital or other institution acting in the normal course of business or employment under registration of the hospital or other registered institution 21 C.F.R. § 1306 “Prescriptions” and “U.S. DOJ DEA Practitioners Manual, Section V, Valid Prescription Requirements,” found at : http://www.deadiversion.usdoj.gov/pubs/manuals/pract/section5.htm .

   7. Formulary Updates

   The formulary consists of all approved medications for each of the five member pharmacy plans (Diagnostic Plan, Standard Plan, Mental Health Plan, Transplant Plan and Cancer Plan). These pharmacy plans contain an extensive list of medications which can be expanded to include other medications upon request from the CCEs and NPN using the forms provided in Appendices 14-C and 14-D. The WTC Health Program may make its own determination to add medications to any of the formularies. The Formulary Change Control Process (FCCP), described below, is the collection of formal procedures used to accomplish these actions.

   1. Formulary Change Control Process (FCCP)

      A medication addition or deletion request can be submitted by a CCE/NPN, the WTC Health Program, or the HPS. All requests should include:

      1. Generic name;
      2. Brand name;
      3. Intended clinical indication;
      4. Justification of medical necessity (including supporting literature references if this is a new product or off-label use);
      5. Cost of supply for a typical therapeutic regimen (i.e., typically 30 days, but may be shorter); and
      6. Average cost of therapeutic class of requested medication.

      If the medication is within an acceptable cost range, it will be added to the appropriate formulary. If not, the WTC Health Program’s pharmacist will conduct additional analysis on the request to include:

      1. Current WTC Health Program formulary alternatives;
      2. Mechanism of action;
      3. Contraindications (in case it is the condition requiring treatment or a commonly-covered WTC Health Program condition); and
      4. Warnings.

      Additions will be communicated to the PBM for implementation and addition to the appropriate place in the formulary within 7 days.

   2. Override Process

      All urgent requests will be sent from the HPS contractor to the Program’s Medical Benefits Team, which has established an internal goal to respond within 2 hours. If no response is received, the HPS contractor will call the WTC Health Program Pharmacy Expert; WTC Health Program Medical Officer; WTC Health Program Medical Benefits Manager; and then the WTC Health Program Associate Administrator, in that order, to obtain approval of the request. After approval, the HPS contractor will process the override for the patient as soon as possible. One-time overrides will be reviewed by the HPS contractor for formal formulary addition.

      The NPN requires PA on several drug classes as noted in the OptumRx chart because they have an open provider network and need to ensure appropriate controls on their part of the program.

   3. Prior Authorizations

      The Program uses a Level 2 or Level 3 Prior Authorization (PA). The Level 2 PA is used when the CCE/NPN Director or the designee approves the use of a medication based on the patient’s condition and use of professional judgment. These overrides are accomplished electronically or with the assistance of the HPS contractor. The Level 3 PA is used in situations when only the WTC Health Program can approve the use of a medication based on the patient’s condition and professional judgment of medical necessity. These approvals are communicated to the HPS contractor and then sent to the PBM to process.

   8. Quality Assurance

   The WTC Health Program uses a variety of methods to ensure quality in the pharmacy program, including:

   • A closed network of authorized prescribers who are selected by the CCEs;
   • A limited formulary;
   • Preference for generics;
   • Adjudication rules preventing early refills, duplicate ingredients, or duplicate fills;
   • Prior authorization requirements on higher-tier drugs or drugs required to address those side effects of covered treatment that impact non-covered conditions; and
   • Limits on dispensed supplies.

   To reduce the risk of misuse, the program requires a 100-percent drug utilization review for members with a cancer certification on a weekly basis at the CCE level. (The NPN completes prior authorizations for all medications for cancer patients and, therefore, has no need to do a retrospective review.) The CCE review includes confirmation of other certifications and reconciliation of certifications, if needed. They may also discontinue any medications that are not appropriate for a member’s certified WTC-related health conditions For additional information see WTC Health Program Bulletin No. 13-24, 21 June 2013, using the Drug Exclusion Form (Appendix 14-E). Additionally, each CCE is required to conduct a monthly drug utilization review on a sample of 5% of the pharmacy claims for member non-cancer certified conditions. The results are provided to the WTC Health Program for review by the Medical Benefits Team.

   In order to monitor and reduce the possibility of fraud, waste, and abuse in the WTC Health Program, six additional areas have been identified for quarterly review based on their potential for misuse. Those areas are:

   • Proton Pump Inhibitors (PPIs),
   • Pain control medications,
   • Erectile Dysfunction (ED) medications,
   • Benzodiazepines,
   • Asthma and COPD control medications, and
   • Blood modifiers.

   The HPS contractor delivers quarterly reports to the Program which include variables such as quantity dispensed, days supply dispensed, cost, frequency of fills, and originating CCE(s). The reports are reviewed by the Program’s Pharmacy Expert and shared with the Program’s Medical Benefits Team. Any areas of concern are communicated to the relevant CCE for further review and action, if required.

   The Program also addresses the potential for waste relating to the use of higher-cost brand medications over generic medications and the use of retail pharmacies over mail-order pharmacies for chronic medications. The HPS contractor generates four reports each month to monitor how the members and providers are filling prescriptions through the WTC Health Program:

   Pharmacy Dashboard

   • Top 10 Medications by Cost Because of their generally higher cost, cancer treatment medications are excluded from this report to avoid skewing the results.
   • Brand/Generic Utilization
   • Mail-Order/Retail Utilization

   The Top Ten Medications by Cost Report and the Pharmacy Dashboard work together to give Program leadership a view of prescription trends. The Pharmacy Dashboard shows the Program-wide view of brand/generic and retail/mail-order use by cost and volume. Supplemental charts provide this information for each CCE, and are presented to the Steering Committees, a committee of laypersons and experts who meet monthly to make sure that the best interests of the patients are being addressed. All of these charts are reviewed by the WTC Health Program Pharmacy Expert monthly to follow trends and make recommendations, where needed.

   The chart below provides a summary of the reports’ intended audience, format, and frequency of review.

   Report Title	Intended Audience	Format	Frequency	Date Range
   Top Ten Medications by Cost (Excluding Cancer Treatment Patients)	WTC Health Program Associate Administrator Review	PDF	Monthly	Previous Month
   Pharmacy Dashboard	WTC Health Program Associate Administrator Review	PDF	Monthly	Previous Month
   Brand v Generic Utilization	Steering Committee Review	PDF	Monthly	Previous Month
   Mail-Order v Retail Utilization	Steering Committee Review	PDF	Monthly	Previous Month
   Blood Product Refill Frequency	WTC Health Program Pharmacist Review	Excel	Quarterly	Previous 3 Months
   Asthma and COPD Control Frequency	WTC Health Program Pharmacist Review	Excel	Quarterly	Previous 3 Months
   Benzodiazepine Medication Refill Frequency	WTC Health Program Pharmacist Review	Excel	Quarterly	Previous 3 Months
   Erectile Dysfunction Refill Frequency	WTC Health Program Pharmacist Review	Excel	Quarterly	Previous 3 Months
   Pain Medication Refill Frequency	WTC Health Program Pharmacist Review	Excel	Quarterly	Previous 3 Months
   PPI Prescription Utilization Report	WTC Health Program Pharmacist Review	Excel	Quarterly	Previous 3 Months

   9. Appendices

   14-A Medications Added to the Standard Treatment Pharmacy Benefit Plan

   Cometriq (cabozantinib)
   Adriamycin (doxorubicin)
   Caprelsa (vandetanib)
   Synthroid (levothyroxine)
   Aldara (imiquimod)
   

   14-B Cancer Status Form (CSF)

   14-C Formulary Addition Request Form WTC 6

   14-D NPN Code Request Form

   14-E Drug Exclusion Form