May 2016—Public Health Law News

Dear Readers,

As international travel and the spread of disease beyond national borders becomes more commonplace, it is imperative that we respond to disease as a global community. The recent Ebola and Zika outbreaks illustrate how a public health threat anywhere can become a public health threat everywhere. An international response to such public health outbreaks requires the use and understanding of national and global public health laws to effectively respond to public health threats while keeping the balance between national sovereignty and global responsibility. The responses to the Ebola and Zika outbreaks are excellent examples of the need for the collaboration among diverse partners, including legal and policy analysts, to improve public health outcomes.

Since August 2015, the Public Health Law Program has leveraged its expertise in legal epidemiology and has partnered with CDC’s Center for Global Health on the Global Health Security Public Health Law Project. The project compiles data on the presence or absence of laws related to each of 11Global Health Security (GHS) targets. By connecting this information to country implementation activities, the project provides a valuable resource for program implementation.

The project includes legal mapping for all GHS phase one and Ebola/high-risk non-affected countries. By understanding the public health law infrastructure in other countries, CDC hopes to provide information that will help these countries build a more agile and responsive public health system. CDC’s project team includes Adam Brush, Acting Associate Director for Policy, Center for Global Health, Team Lead, Akshara Menon, Public Health Analyst, Carter Consulting, Inc., Contractor, Public Health Law Program, and Emily Rosenfeld, ASPPH/CDC Global Health Fellow.

During the coming months, the Public Health Law News  will highlight aspects of the Global Health Security Public Health Law Project and other global public health law issues. This month, we are also launching a Global Public Health Law section of the News.

We hope you enjoy this new feature.

Sincerely,
F. Abigail Ferrell, JD, MPA
Editor in Chief
Public Health Law News

Emergency Dispensing Orders. On April 13, 2016, the US Food and Drug Administration (FDA) issued two emergency dispensing orders for oral dosage forms of doxycycline (doxy) and ciprofloxacin (cipro) products for the post-exposure prophylaxis of inhalational anthrax during an anthrax emergency. These orders were issued in close coordination with CDC, which issued corresponding Emergency Use Instructions for doxy and cipro.

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New FDA Draft Guidance for Emergency Use and Authorization of Medical Products and Related Authorities. The FDA is accepting comments on the draft guidance until June 3, 2016.

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Job Opening: O’Neill Institute for National and Global Health Law. The O’Neill Institute for National and Global Health Law seeks an associate to work on domestic and global health law and policy projects. Candidates should have a JD degree, and candidates with advanced training in public health and economics are preferred. Experience in public health law and financing; health reform and healthcare systems (United States and comparative); and food and drug law is also preferred. Position closes May 31, 2016.

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2016 Public Health Law Conference. The Public Health Law Conference will take place September 15–17, 2016, in Washington, DC. The conference, hosted by The Network for Public Health Law, is for public health lawyers, practitioners, officials, policy makers, researchers, and advocates. Conference attendees will learn about laws and policies affecting critical public health issues, such as disease prevention, drug overdose, health data sharing, and access to care. Early bird registration ends August 16, 2016. A preliminary agenda is available now.

Attention-Deficit/Hyperactivity Disorder Resources. CDC’s Public Health Law Program (PHLP), in collaboration with CDC’s National Center for Birth Defects and Developmental Disorders and the Robert Wood Johnson Foundation’s Public Health Law Research Program at Temple University, has released a suite of resources related to attention-deficit/hyperactivity disorder (ADHD), including

• Prior-Authorization Policies for Pediatric ADHD Medication Prescriptions Map. This LawAtlas dataset examines features of state Medicaid prior-authorization policies that pertain to pediatric ADHD medication treatment, including applicable ages, medication types, and criteria for approval.
• Treating Attention-Deficit/Hyperactivity Disorders in Children Under Age Six Years: A Research Anthology [PDF 304KB]. This list of readings and resources on ADHD treatment policy options includes information on Medicaid drug prior authorization and reimbursement for behavioral therapy.
• Vital Signs: ADHD in Young Children. The May 3, 2016, Vital Signs discusses the underuse of the recommended first-line treatment for young children with ADHD.

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Healthy People 2020  Law and Policy Project Resources. PHLP, in partnership with the Healthy People 2020  initiative (HP2020), has published four new legal and policy resource anthologies related to HP2020  topic areas, including mental health and mental disorders, older adults, oral health, and substance abuse.

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Electronic Health Record Toolkit. Through a collaboration with CDC’s Division for Healthcare Quality Promotion, the Association for State and Territorial Health Officials, and the Keystone Center, PHLP examined the use of law and legal tools to improve access to electronic health record (EHR) systems in healthcare facilities during outbreaks. This toolkit can help health department professionals work with healthcare facilities during outbreaks (including outbreaks of healthcare-associated infections) to secure access to EHR systems and facilitate outbreak investigations.

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Preparing for a Pandemic: An Emergency Response Benchbook and Operational Guidebook for State Court Judges and Administrators. The National Center for State Courts, with support from a State Justice Institute grant, released a pandemic response benchbook for state court judges.  

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Zika Virus Response Updates from FDA. The FDA website provides information and updates on its actions related to the Zika virus.

Peabody coal’s contrarian scientist witnesses lose their court case
The Guardian   (05/02/2016)   John Abraham

Peabody Coal, the largest coal company in the United States, filed for bankruptcy on April 13, 2016. On April 15, 2016, an administrative law judge from the State of Minnesota Office of Administrative Hearings for the Public Utilities Commission decided that the estimated cost of carbon pollution used in Minnesota was too low. This decision means that the estimated cost of coal will increase from $0.44–4.53 per ton to $11–57 per ton.

The case, brought by the Minnesota Center for Environmental Advocacy and their clients, Fresh Energy and the Sierra Club, involved testimony from environmental impact experts from both sides. Peabody’s arguments largely relied upon non-peer-reviewed reports, blog sites, and think tanks.

The Administrative law judge was unconvinced by these arguments, concluding in part, “The administrative law judge concludes that Peabody failed to demonstrate that an equilibrium climate sensitivity of 1 or 1.5 [degree(s)] Celsius is correct . . . that the climate sensitivity is reasonably considered to be in the 2–4.5 [degrees] Celsius range . . . [and] Peabody failed to demonstrate that the relied-upon process is neither peer-reviewed nor transparent.”

[Editor’s note: Read the State of Minnesota Office of Administrative Hearings for the Public Utilities Commission report [PDF - 1.77MB].]

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Pakistan: Seven policemen guarding polio workers shot dead in Karachi
Dawn   (04/20/2016)   Mohammad Raza

Seven police officials guarding polio workers were attacked and killed by gunmen on motorcycles in Orangi Town, Karachi, Pakistan. The first attack occurred while the police escorted the polio team, and the second attack targeted police officials sitting in a police van. No polio workers were reported injured, but the anti-polio campaign was suspended immediately. Paramilitary soldiers closed off the crime scene and guarded the area.

In a statement from his office, Prime Minister Nawaz Sharif respected the acts of the police officials and said, “They laid down their lives to secure the country’s future.” Polio is still prominent in not just Pakistan, but also its neighboring country, Afghanistan. Despite the unfortunate attack in Karachi, stronger security will be provided for the polio workers, and the campaign to eradicate polio will continue.

[Editor’s note: Learn more about polio and CDC’s work toward polio eradication.]

California: California becomes the latest state to raise legal tobacco age to 21
The Blaze   (05/05/2016)   Jon Street
[Editor’s note: Find more information and read Have Tobacco 21 Laws Come of Age?, by Stephanie R. Morain, PhD, Jonathan P. Winickoff, MD, MPH & Michelle M. Mello, JD, PhD, in the New England Journal of Medicine (Apr. 28, 2016). Doi: 10.1056/NEJMp1603294.]

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California: California recreational marijuana initiative will be on the November ballot
The Guardian   (05/04/2016)   Maria L. La Ganga

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Michigan: Flint water crisis: who’s been charged, who hasn’t
CNN   (04/22/2016)   Ray Sanchez

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New Jersey: NY, NJ sharing Rx information
NY1   (04/29/2016)   Tanya Klich

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New York: Bartenders can’t refuse pregnant women alcohol, New York City says
New York Times   (05/09/2016)   Mike McPhate
[Editor’s note: Read the New York City Commission on Human Rights Legal Enforcement Guidance on Discrimination on the Basis of Pregnancy: Local Law No. 78 (2013); N.Y.C. Admin. Code § 8–107(22) [PDF - 772KB].]

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North Carolina: Concerned about veteran with PTSD, judge orders him to jail and serves the time with him
ABA Journal   (04/22/2016)   Debra Cassens Weiss
[Editor’s note: Learn more about post-traumatic stress disorder (PTSD).]

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North Carolina: North Carolina’s bathroom bill is a constitutional monstrosity
The Atlantic   (05/10/2016)   Garrett Epps
[Editor’s note: Read North Carolina’s House Bill 2 [PDF - 142KB].]

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Oregon: Over-the-counter birth control is here, and it’s awesome
Glamour   (05/03/2016)   Jennifer Gerson Uffalussy
[Editor’s note: Read Oregon’s HB 3343 A on over-the-counter contraceptives.]

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National: Unsurprisingly, study shows promoting abstinence doesn’t prevent HIV transmission
Newsweek   (05/03/2016)   Jessica Firger
[Editor’s note: Read PEPFAR Investments in Governance and Health Systems Were One-Fifth of Countries’ Budgeted Funds, 2004–14, Corrina Moucheraud et al., Health Affairs 35(5):847–55 (May 2016). Doi: 10.1377/hlthaff.2015.1445.]

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National: FDA to begin regulating electronic cigarettes
Los Angeles Times   (05/05/2016)   James F. Peltz and Ronald D. White
[Editor’s note: Read the FDA press release, FDA takes significant steps to protect Americans from dangers of tobacco through new regulation, and learn more about the new regulation.

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National: New discovery means more US states will face risk from Zika
The Washington Post   (04/29/2016)   Nick Miroff
[Editor’s note: Learn more about Zika, Zika-related law and policy issues, and the FY2016 Emergency Supplemental Appropriations Request [PDF - 3.01MB] for $1.9 billion to respond to the Zika virus.]

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National: 52 statehouse reporters review the top 5 public policy issues in each state
CQ Roll Call   (05/03/2016)   Ann Dermody

Australia: Tobacco tax increase will cut smoking rates, say public health experts
News ABC   (05/03/2016)   Lexi Metherell

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India: More than 300 million Indians suffer from a crippling drought 
The Washington Post   (05/04/2016)   Rama Lakshmi

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Kenya: Kenya says it will close all refugee camps, displacing 600,000 people
The Washington Post   (05/09/2016)   Max Bearak

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United Kingdom: [National Health Service] fined for 56 Dean Street HIV status leak
BBC   (05/09/2016)   Chris Foxx

Interview with Rachel Hulkower, JD, MSPH, Legal Analyst/ORISE Fellow

Title:
Legal Analyst/ORISE Fellow for the Child Development Studies team of the National Center on Birth Defects and Developmental Disabilities

Education:
I have a master of science in public health (MSPH) from the University of North Carolina Gillings School of Public Health and a JD, with a health law certificate, from Georgia State University College of Law.

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Public Health Law News (PHLN): Please describe your career path.

Hulkower: I’ve always aimed for a career in public health. After I received an MSPH, I came to Atlanta to work at CDC as a microbiologist in the Streptococcus laboratory at CDC’s National Center for Immunization and Respiratory Diseases. I loved working in the lab! While there, I had the opportunity to contribute to the development of testing protocols for various Streptococcus surveillance programs, meet and collaborate with researchers from labs around the world, and participate in CDC’s response to the H1N1 influenza outbreak in 2009.

But I also was interested in learning about what happened after the scientific information left the lab. So the obvious choice was to go to law school! I graduated from law school with a certificate in health law and clerked for a judge in the United States District Court for the Northern District of Georgia for about two years.

Finally, I returned to CDC in 2015 to do public health law research for PHLP and the Child Development Studies (CDS) team within the National Center on Birth Defects and Developmental Disabilities (NCBDDD).

PHLN: What drew you to public health law?

Hulkower: It’s a field that allows me to merge my hard sciences background with my understanding of the law and to use that combination as a tool for protecting and promoting the public’s health.

PHLN: Would you please describe your day-to-day job responsibilities?

Hulkower: I provide support, technical assistance, and targeted research guidance related to public health law to NCBDDD’s CDS team. I also implement legal epidemiology methodologies for a cross-organization partnership between PHLP and the CDS team. In furtherance of CDC’s Winnable Battles priority regarding the treatment of attention-deficit/hyperactivity disorder (ADHD) in young children, I, along with researchers at Temple University, have been conducting a 50-state legal assessment and developing a database of state Medicaid prior-authorization policies for medication prescribed to treat ADHD in children. I also have helped CDS develop an evaluation tool to survey state Medicaid programs about their policies that may guide physicians toward best practices for ADHD treatment.

PHLN: What is your favorite part of your job?

Hulkower: My favorite part of the job is getting to learn about all of NCBDDD’s various projects related to child development—such as promoting evidence-based pediatric ADHD treatment or emergency preparedness for newborn screening requirements—and figuring out how to use the law as a tool to further CDS’s goals related to these projects.

PHLN: What is ADHD?

Hulkower: ADHD is a neurodevelopmental disorder that affects approximately 6.4 million children, aged 4–17 years. Children with ADHD demonstrate persistent behavioral symptoms, such as inattention, hyperactivity, and impulsivity in various environmental settings. For more information about ADHD, see CDC’s web page dedicated to the disorder.

PHLN: How is ADHD diagnosed?

Hulkower: Clinical guidelines for ADHD diagnosis are available from the American Academy of Pediatrics (AAP). Overall, it is recommended that healthcare providers use standardized rating tools to collect information about ADHD symptoms and impairment from parents and other adults who know the child, such as teachers and coaches. It’s also recommended that other potential causes of the ADHD symptoms, such as sleep disorders or anxiety, be ruled out. CDC’s website on ADHD diagnosis has more information.

PHLN: What is the recommended treatment for children with ADHD? Do the recommendations change for different demographics, such as age and gender?

Hulkower: In 2011, the AAP updated its previously published clinical practice guidelines with recommendations for the diagnosis and treatment of pediatric ADHD. Those treatment recommendations vary by age. For preschool-aged children (aged 4–5 years), the AAP recommends that a primary care provider prescribe evidence-based parent- or teacher-administered behavior therapy as the first line of treatment, followed by medication, only if behavioral therapy fails to provide significant improvement in the child’s functioning. For children aged 6–11 years, the AAP recommends a combination of FDA-approved ADHD medication and behavioral therapy. For children aged 12–18 years, the AAP recommends prescribing psychotropic medications in combination with behavior therapy.

[Editor’s note: Learn more about guidelines for ADHD diagnosis and treatment. Mary M. Gleason et al., Psychopharmacological Treatment for Very Young children: Contexts and Guidelines [PDF - 3.92MB], 46 J. Am. Acad. Child & Adolescent Psychiatry 1532 (2007).

Am. Acad. of Pediatrics, Subcomm. on Attention-Deficit/Hyperactivity Disorder, Steering Comm. on Quality Improvement & Mgmt., ADHD: Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents [PDF - 6.34KB], 128 Pediatrics 1 (2011).]

PHLN: How do ADHD treatment guidelines relate to the law?

Hulkower: While clinical guidelines recommend behavioral therapy first for ADHD treatment in young children, these recommendations do not legally bind a provider to treat pediatric ADHD in any particular manner. And, when best practice recommendations are compared to epidemiological statistics, it appears there is a misalignment between current and best practice for pediatric ADHD treatment. In a recent study of administrative claims data from Medicaid and a source of employer-sponsored insurance, CDC researchers found that, from 2008 to 2014, about half of young children, 2–5 years of age, with an ADHD diagnosis were not receiving psychological services, which may include the recommended treatment of parent training in behavior therapy. They also found that about three-quarters of young children with ADHD received medication as treatment. This suggests that too few young children are receiving the recommended ADHD treatment of behavior therapy.

States may use various legal or policy measures to try to guide physicians toward best practices for ADHD treatment, including insurance prescription prior-authorization policies, informed consent training as part of licensure requirements, and programs that expand access to and use of behavioral therapy or telemedicine. Medicaid prior-authorization policy interventions, for example, may guide clinicians toward referral for behavior therapy, by denying coverage for ADHD medication prescriptions unless the prescribing physician affirms that non-pharmacological treatment was tried first and had failed to improve the child’s ADHD symptoms.

PHLN: Please describe your research regarding Medicaid policies for ADHD treatment.

Hulkower: NCBDDD has identified Medicaid prior-authorization policy interventions as a set of strategies that may control the use of ADHD medication among young patients diagnosed with ADHD and may guide clinicians towards referral for behavior therapy. To allow us to evaluate the impact of such policies, a CDC research team and I, along with two legal researchers from Temple University’s Policy Surveillance Program, conducted a preliminary cross-sectional mapping study of state Medicaid pediatric ADHD medication prior-authorization policies, as of November 1, 2015. The team conducted a search for Medicaid prior-authorization policies involving the prescription of ADHD medications, stimulant medications, or psychotropic medications to children younger than age 18 years in the 50-state jurisdictions and Washington, DC. We developed a coding scheme that incorporated the key features of these prior-authorization policies and recorded these features in an interactive database that is available to the public, as well as state and federal Medicaid program decision makers, at LawAtlas. This information is being evaluated in conjunction with Medicaid claims data for diagnosis and treatment of ADHD with prescription medications and psychological treatment services. The team aims to analyze and understand how and to what extent Medicaid prior-authorization policies for pediatric ADHD medications affect ADHD treatment patterns.

PHLN: How might this research apply to future public health outcomes?

Hulkower: This research can serve as an example of the effects that prior-authorization and other reimbursement policies might have on physicians’ treatment patterns related to other developmental disabilities.

PHLN: How do ADHD policies relate to other developmental policy issues?

Hulkower: Many states have prior-authorization requirements for coverage of antipsychotic medication prescribed to treat children with disorders such as schizophrenia, bipolar disorder, or very severe depression. Similar to ADHD treatment authorization policies, antipsychotic medication prior- authorization policies are designed to control prescription rates of these medications to children. Analyses of the prior-authorization process for antipsychotic medication prescriptions show evidence of reduced prescriptions for antipsychotic medications to children. These analyses offer insight into the potential outcome of Medicaid programs’ use of prior authorization to manage ADHD medication prescription, as well as the legal and policy issues that can arise when analyzing prior-authorization policies for ADHD medications.

PHLN: How can people learn more about ADHD policies and treatment guidelines?

Hulkower: There are many great resources available to those interested in learning more about ADHD treatment, including CDC’s page on ADHD treatment. PHLP’s website also houses a list of readings and resources on ADHD treatment policy options. As a result of CDC’s collaboration with ChangeLab Solutions and Temple University, the results of our 50-state legal assessment of state Medicaid prior-authorization policies for medication prescribed to treat pediatric ADHD are available. Readers can learn more about the ADHD treatment guidelines published by the AACAP [PDF - 3.92MB] and the AAP [PDF - 634KB].

PHLN: What other projects are you currently working on?

Hulkower: I’m currently helping to develop a survey of Medicaid Medical Directors to collect information about the characteristics of and implementation of state Medicaid policies that may impact the treatment of pediatric ADHD, including prior-authorization policies. Like the 50-state assessment of Medicaid prior-authorization policies for ADHD medications, I’m collaborating with Temple University’s legal analysts to collect and catalogue Medicaid policies related to behavioral health services reimbursement. The survey to Medicaid medical directors also will be used to collect information about Medicaid behavioral services reimbursement and to validate our legal epidemiology methods.

Additionally, I’m providing input on legal considerations to highlight in CDC’s update of the National Newborn Screening Contingency Plan for use by a state, region, or consortia of states, in the event of a public health emergency.

Finally, the CDS team is beginning work to create an early childhood policy database based on the family, neighborhood and healthcare factors identified as significant contributors to mental, behavioral, and developmental disorders in early childhood. For more, see the Morbidity and Mortality Weekly Report (MMWR) article from March 11, 2016, Health Care, Family, and Community Factors Associated with Mental, Behavioral, and Developmental Disorders in Early Childhood—United States, 2011–2012.

PHLN: What would you be doing if you weren’t practicing public health law?

Hulkower: Ideally, I’d be working at CDC in another role. Or, baking sweet treats that make people smile at a cleverly named bakery in Asheville, NC.

PHLN: Have you read any good books lately?

Hulkower: Yes! I recently enjoyed The Bone Clocks, by David Mitchell, and Simon vs. the Homo Sapiens Agenda, by Becky Albertalli, and right now, I am reading Lab Girl, by Hope Jahren.

PHLN: If you could travel anywhere in the world, where would you go and what would you do?

Hulkower: I would travel to Southeast Asia. I would try all the foods and learn about the culture and history of countries like Vietnam, Cambodia, and Thailand, which I know very little about. I would also sneak in some hiking and beach time.

PHLN: Do you have any hobbies?

Hulkower: I enjoy baking cookies and cupcakes, road biking, yoga, and hiking.

The first reader to correctly answer the quiz question will be given a mini public health law profile in the June 2016 edition of the News. Email your entry to PHLawProgram@cdc.gov with “PHL Quiz” as the subject heading; entries without the heading will not be considered. Good luck!

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Public Health Law News Quiz Question: May 2016

What new content section was launched in the May 2016 edition of the Public Health Law News?

Question: Which state health department had a job opening announced in the April 2016 edition of the Public Health Law News?

Answer: South Carolina

Illinois: Work-related blister “but for” cause of plaintiff’s subsequent infection, plaintiff’s lancing of the blister did not break the causal chain
Dunteman v. The Illinois Workers’ Compensation Commission
Appellate Court of Illinois, Fourth District, Workers’ Compensation Commission Division
Case No. 4-15-0543WC
Filed 04/29/2016

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Michigan: Clinic suit against market for gasoline leak onto property dismissed without prejudice in favor of ongoing environmental investigation, affirmed by appellate court
Carson City Hospital v. Quick-Sav Food Stores, Ltd.
Court of Appeals of Michigan
Case No. 325187
Filed 04/28/2016
Opinion per curiam

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Michigan: Unlicensed massage therapists’ services not legally rendered and therefore not eligible to receive benefits under the no-fault act
Revive Therapy v. State Farm Mutual Insurance Company
Court of Appeals of Michigan
Case No. 324378
Opinion per curiam

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Texas: Houston can incorporate Texas Commission on Environmental Quality rules in air-quality ordinance
BCCA Appeal Group, Inc. v. City of Houston, Texas
Supreme Court of Texas
Case No. 13-0768
Filed 0429/2016
Opinion by Justice Paul W. Green

Quotation of the Month: Sindh Police Inspector General Ad Khawaja

“Polio drops will be administered to our children at all costs … [police are] ready to render more sacrifices if need be,” said Sindh Police Inspector General Ad Khawaja of the fatal shooting of seven policemen guarding polio workers in Karachi, Pakistan.