April 2016—Public Health Law News

New FDA Draft Guidance for Emergency Use and Authorization of Medical Products and Related Authorities. The US Food and Drug Administration (FDA) is accepting comments on the draft guidance until June 3, 2016. Submit electronic comments to http://www.regulations.gov.

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CDC FY15 Grant Funding Profiles. CDC has posted FY2015 funding data and jurisdictional profiles on its CDC Grant Funding Profiles site. The profiles provide quick access to information about CDC funding provided to health departments, universities, and other public and private agencies in US states and territories and the District of Columbia.

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Prevention Status Reports. CDC's Prevention Status Reports (PSRs) highlight the status of state-level policies and practices to address critical public health problems. Reports are available for all 50 states and the District of Columbia on the following 10 health topics: alcohol-related harms; healthcare-associated infections; heart disease and stroke; HIV; motor vehicle injuries; nutrition, physical activity, and obesity; prescription drug overdose; teen pregnancy; and tobacco use. Because many PSR topics relate to public health law, CDC’s Public Health Law News will feature different PSR topics in the coming months. Read the reports and check out the prescription drug overdose indicators. One requires timely data submission to the state prescription drug monitoring program. Another requires prescribers’ universal use of prescription drug monitoring programs. 

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Job Opening: South Carolina Department of Health and Environmental Control. South Carolina Department of Health and Environmental Control’s (DHEC’s) Office of General Counsel is seeking an experienced attorney to be the sole advisor to the state of South Carolina for all questions about public health protection. This attorney will provide legal advice to the board, the director, and DHEC’s health services programs; work closely with program directors, administrators, and staff engaged in specialized areas of healthcare delivery, healthcare policy, and public health services and initiatives; draft and review contracts prior to department release and advise department staff on state and federal health privacy and statutory and regulatory matters. Candidates need not be a member of the bar in South Carolina but must become so within a year of hire. The position closes May 9, 2016.

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Job Opening: O’Neill Institute for National and Global Health Law. The O’Neill Institute is seeking an exceptionally qualified candidate to serve as an O’Neill Institute Fellow. Housed at Georgetown University Law Center in Washington, DC, the O’Neill Institute is a leading research institute for health law. Candidates should have a JD degree (or equivalent); exceptional academic credentials, including publications; and health law-related research interests in areas like public health law, global health law, domestic health care law, empirical studies, regulatory impacts of health, health, human rights, etc. Successful candidates will have knowledge and/or experience in aspects of national and or global health law and ethics. A post-graduate degree (MPH, LLM), health degree, or significant work experience may be preferred. Position closes May 8, 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 a candidate to serve as an O’Neill Institute Associate to work on domestic and global health law and policy projects. Candidates should have a JD degree and outstanding research and writing skills. Candidates with advanced training in public health and economics are preferred. They also should have experience in areas such as public health law and financing; health reform and healthcare systems (United States and comparative); and food and drug law. Position closes May 31, 2016.

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2016 Policy Surveillance Summer Institute. The Robert Wood Johnson Foundation Policy Surveillance Program is hosting its inaugural Policy Surveillance Summer Institute, June 9–10, 2016, at Temple University in Philadelphia, Pennsylvania. The Summer Institute will teach policy surveillance and legal mapping techniques. It will provide hands-on lab training with software tools, classroom instruction, and opportunities to network with other law or policy professionals and engage with Policy Surveillance Program staff. Participants will learn the entire process, from conceptualizing a dataset through web-deployment tools for visualizing policy over jurisdictions and time.

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2016 Public Health Law Conference. The Public Health Law Conference will take place September 15–17, 2016, at the Grand Hyatt, 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 8, 2016. A preliminary agenda is available now.

Tribal Consultation Readings and Resources [PDF - 279KB]. The Public Health Law Program (PHLP) published Tribal Consultation: Selected Readings and Resources, a collection of materials that describe and offer commentary on state and federal tribal consultation. The list includes summaries of relevant laws, scholarly articles, and resources for consultation support.

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Menus of State Healthcare Facility Varicella and Pertussis Vaccination Laws. PHLP published inventories of state laws that establish varicella and pertussis vaccination requirements for healthcare workers and patients.

• Menu of State Healthcare Facility Varicella Vaccination Laws [PDF - 390KB]
• Menu of State Healthcare Facility Pertussis Vaccination Laws [PDF - 368KB]

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Zika-Related Legal Resources. PHLP has published a suite of resources and information addressing potential questions from public health responders and the public about Zika-related legal issues.

Lawmakers urge administration to update health IT rules
The Commonwealth Fund   (03/22/2016)   Andrew Siddons

A variety of federal rules apply to electronic health records. As such records become more prevalent, lawmakers on the House Oversight and Government Reform Committee recognize a need to update the laws to make them more user friendly.

“The sheer number of federal agencies, with often conflicting rules one must navigate to invest in the space, chills investment and entrepreneurship. The fragmented and bureaucratic system places the patient at the fringe of the process rather than at the center,” said Rep. Will Hurd, Texas, chairman of the House Oversight and Government Reform Subcommittee on Information Technology.

Concerns extend from the committee to federal agencies, too. Karen DeSalvo, the US Department of Health & Human Services’ national coordinator for health IT, knows the frustration first-hand, from her experiences as a physician. “I have been frustrated by the lack of interoperability, by the usability of the systems and by how hard it can be to select the right system to operate,” DeSalvo said. She recommended lawmakers encourage states to synchronize health data, prevent or discourage health care providers from intentionally making their data hard to share with others for commercial reasons.

While the need for innovation and change is widely recognized, other subcommittee members encourage moderation. “Regulation done wrong or too little regulation makes it difficult to protect the public and make sure the data flows freely. Regulations done right spurs innovation, improves quality of care, and protects the public,” said Rep. Ted Lieu, California.

Indiana: 190 people in this Indiana town are HIV-positive
WHIO   (04/11/2016)  
[Editor’s note: Learn more about Fayette County, Indiana’s syringe exchange program.]

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Maine: Portland could up tobacco buying age to 21
WMTW.com   (0411/2016)   Kyle Jones

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New York: Firm to pay AIDS activist for denying him housing
New York Times   (04/10/2016)   Noah Remnick

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New York: New York ranks 2nd in cases of Zika virus
New City Patch   (04/11/2016)   Lanning Taliaferro
[Editor’s note: Read about New York’s 6-Step Zika Action Plan and Regulation § 40-2.24 Zika Action Plan, which requires local health departments to adopt and implement a Zika action plan by April 15, 2016.]

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Texas: How Texas’ fetal tissue laws are helping researchers develop a Zika vaccine
Kut.org   (04/01/2016)   Ashley Lopez
[Editor’s note: Learn more about embryonic and fetal research laws.]

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Utah: Utah colleges must ask about organ donation
Good4Utah   (04/07/2016)   Glen Beeby
[Editor’s note: Read Utah’s 53B-1-111, Utah Code annotated 1953.]

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National: FDA requires ‘black box’ warning on painkillers
CNN   (03/24/2016)   Nadia Kounang
[Editor’s note: Read FDA’s final guidance on the evaluation and labeling of abuse-deterrent opioids [PDF - 226KB].]

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National: Streamlining Medicaid enrollment: the role of the health insurance marketplaces and the impact of state policies
The Commonwealth Fund   (03/30/2016)   Sara Rosenbaum, Sara Schmucker, Sara Rothenberg, and Rachel Gunsalus

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National: Synthetic drugs: an emerging, evolving threat
Governing   (04/2016)   John Buntin

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National: U.S. officials warn Zika ‘scarier’ than initially thought
Reuters   (04/11/2016)   Timothy Gardner and Jeff Mason
[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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International: Model in Gucci ad is deemed ‘unhealthily thin’ by British regulator
New York Times   (04/06/2016)   Dan Bilefsky

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International: ‘Need your prayers’: The youth-suicide crisis gripping a Canadian community 
The Washington Post   (04/13/2016)   Elahe Izadi

Interview with Darrell Klein, JD

Title: Assistant Agency Counsel, State of Nebraska Department of Health and Human Services

Education:

• JD, Creighton University School of Law
• BA, History, Political Science, Doane College

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Public Health Law News (PHLN): What inspired you to become an attorney?

Klein: I was intensely interested in politics, even in junior high school, and I noticed that most folks in Congress were lawyers, so I decided early on to go to law school. I also assumed that with an understanding of the facts, the way society functioned could be improved.

PHLN: For someone who didn’t set out to practice public health law, you’ve been practicing public health law for a long time. What do you enjoy about the practice of public health law?

Klein: One thing that should be taught before anyone can take the LSAT is that the practice of law is always about addressing and overcoming someone else’s problems. The huge advantage of working in government, particularly public health, is everyone around you should be doing their best to help people and to “do good.” In private practice, you take your client as you find them, and usually you are addressing the problems “after the fact.” While that is not totally absent in public health law practice, there is a significantly greater opportunity to help plan and address issues before there are any significant problems. Plus, you are working on the side of angels.

PHLN: Please describe your day-to-day job responsibilities?

Klein: Every day, I try to get everyone to understand that I know best and to simply follow what I say. Rick Hogan and Gene Matthews showed me that excellent legal advice can be delivered with subtle humor and I am nothing but subtle, as everyone knows. Strangely, my approach does not work at all at home, and I am not totally sure it works at work, although folks do laugh a lot.

My CV says that my practice focuses on support of epi (epidemiology) surveillance and health data programs, public health emergency preparedness, coordination with Nebraska’s local public health departments and ongoing development and implementation of public health responsibilities with emergency management for all-hazards response. I am the lead attorney for the Nebraska Certificate of Need program, advise health care professional boards, advise on public policy and legislative issues as requested, and prosecute contested cases for assigned programs at the administrative level and in court upon appointment.

My LinkedIn profile shows the astounding number of organizations that have painfully learned, first hand, that one organization’s “SME” is another organization’s Smeagol. Or maybe they’re just all trying to prove they can take it.

My real job description is like every attorney’s: I try to answer whatever questions folks have when they call or drop by, or if they are sitting as finders of fact.

PHLN: What have been some of the most interesting cases you’ve worked on?

Klein: Well, in private practice, in my first jury trial, I obtained a directed verdict in our favor in a lawsuit between sisters over a stolen/borrowed bicycle and the subsequent assault-by-mutual-consent. If that had occurred 5,000 years ago, it might have been included in the Old Testament. A felony drug defense was nerve-wracking. Recently in public health law, I’d have to say a successful defense of a public record mandamus action seeking a recent food-borne disease outbreak epi investigation. I learned that interested non-parties sometimes tweet unkind things about a state’s legal position prior to litigation. Certificate of Need cases are very intense, as they are detailed and usually involve math.

At one point about a decade ago, I was litigating 45% of the agency’s administrative cases and had an almost four-year undefeated stretch. One of those cases involved a fine fellow who had stabbed a nursing home resident with a fork (no permanent injury). As we tried the case revoking his credential, I was amazed to see that he had a swastika on his forehead, ala that wanna-be musician locked up in California. Even more amazing is that it turned out he didn’t and that was just my imagination projecting the apt image. Subconscious trial technique? So there’s something everyone might consider in their litigation practice.

PHLN:  Can you please describe how you became involved with state preparedness issues?

Klein: The first CDC PHLP Public Health Emergency Law (PHEL 1.0) Train the Trainers course was scheduled for April 2005 (getting states’ Public Health and Emergency Management together in beautiful downtown Atlanta). PHLP was under the tutelage of Rick Goodman and Tony Moulton. Toiling away in federal PH (public health) land, were the intellectual giants Ernie Abbott and Gene Matthews (and no doubt others). There I was, sitting in the office of my boss, Roger Brink, discussing Matters of Great Import. Chief Medical Officer Richard Raymond appeared in the doorway and said: “Which one of you guys is going to this?,” as he tossed the conference brochure in our general direction.

With no more and no less than a millisecond’s delay, Brink pointed his finger in my face and said: “Klein will go.”

As I looked at the brochure, it dawned on me that the topic of Unit Three: “Protection of People” (aka quarantine and isolation) looked an awful lot like a presentation I was scheduled to make to our local public health department directors. Since I hadn’t started on my presentation I thought to myself: “What to do … What to do?” Then it came to me! Steal their work!

I called the contractor for PHLP and asked for a copy of the PowerPoint®, which he graciously emailed to me. “Perfect” I thought to myself in Montgomery Burns’ voice.

The next day, my phone rang. “I am Rick Goodman” the headset asserted. “Who are you, and why did you want our product from our contractor???”

“I am lazy and interested in ‘borrowing’ your hard work,” I replied, forgetting that I wasn’t under oath.

Unnerved by my abrupt honesty, Rick said “. . . Okay . . . You can use it. Present it to your local health departments, and then you must COME TO ATLANTA AND PRESENT IT HERE AND TELL US HOW IT WENT.”

A star was born.

That, plus I had already been assigned to support state preparedness efforts and co-authored our Directed Health Measure regulations and a template for our local public health departments, as well.

PHLN: What is the Nebraska Public Health Laws Project?

Klein: Jenn Ibrahim will give you a better answer, but it is an outgrowth of her PHLR efforts to create an interactive Internet-based tool on a variety of public health legal topics across all states to engage the PH practitioner with PH law as a tool and ultimately, part of an effort to measure the efficacy of those laws.

For LawAtlas and the Nebraska LawAtlas, the best thing I can say is go to the site and play with it. Go right now, and stop reading this.

For the Nebraska LawAtlas, the scope was to include all-state level and many local statutes, ordinances and regulations governing, impacting or advancing public health. From time to time, Jenn and I both thought, and heard from others, “Whoa, that can’t be done.”

PHLN: What was your role in helping to create the Nebraska Public Health Laws LawAtlas collection?

Klein: As with so many things, it began by answering an email. I received a survey sent from Jenn’s outfit—before I knew Jenn—to state and local health departments to assess the relationship between public health legal support and public health management.

Jenn said a small group of responders were selected for a follow-up phone interview, based on the written responses, and Nebraska (Dr. Schaefer and I) was selected. In spite of learning that I can—and will, if not prevented—talk for days. Jenn was impressed with the close relationship between legal and management here.

For the Nebraska LawAtlas project itself, my initial job was to get approval from Chief Medical Officer Dr. Joann Schaefer. This was easy, as public health “legal” has a long history and close professional relationship with PH management. Plus, I had never been wrong. So I had that going for me.

My role in the project itself was to help identify and provide access to Nebraska public health laws so the PHLR folks could load them and code them into the interactive user-friendly interface.

PHLN:  What made this project a good fit for Nebraska?

Klein:  “Public Health Legal” here had previously prepared indices and summaries of the public health laws the state public health agency is charged with administering. These began as papers-in-notebooks for incoming public health officers. However, we had later versions in word-processing format and our state statutes and regulations are online, as are the laws of the larger local public health departmental entities in Nebraska.

PHLN:  Why does Nebraska’s Department of Health and Human Services have such a strong relationship with its legal counsel? Are such relationships common for state public health agencies?

Klein:  I believe, in Nebraska, it may flow from the structure and personnel of the agency dating from the 80’s. Dr. Wright was the Director of Health and his father was a prominent local attorney. The agency, Legal Counsel, had worked at that law firm, so the respect for the law was reinforced. Public health legal support is in-house, although the Attorney General’s (AG’s) office has primary litigation responsibility over a number of areas of law. However, in-house agency counsel also serve as Special AGs, upon appointment. Coupled with our co-location near management’s office is the fact that recently, an increased number of agency managers are JDs. Plus, giving good advice and never being wrong helps. Did I mention that already? Among the state PH attorneys I speak with regularly, I believe they all have strong relationships with their clients (but not in a way that bothers HR!).  That may be a chicken-and-egg thing: effective attorneys foster a good working relationship, which helps the attorneys be effective. FYI: the wrong answer to the chicken-and-egg question was fatal to some folks who didn’t expect the Spanish Inquisition (but then again, no one expects the Spanish Inquisition).  I believe being co-located and “in-house” has advantages. 

PHLN: How do you hope the data collected through the Nebraska Public Health Laws Project will be used?

Klein: For good, I hope. Always opt for good over other alternatives. I expect the interface is more intuitive for public health practitioners than traditional compilations of the law, and will actually be a bit of fun. If the law is demystified, it can be better and more widely understood and followed. The LawAtlas’ topical organization is designed to fit public health practice and be more user-friendly than statutory compilations.  (I confess I had to look up “taxonomy” when Jenn discussed it; she had to put up with a lot on the project).

PHLN: Why might this information be particularly useful for local health departments?

Klein: Many of our local public health departments (LPHDs) do not have a budget that allows for     full-time legal counsel. Although the larger LPHDs have a dedicated county or city attorney for support, most LPHDs are multi-county, and no single county attorney is responsible to support the multi-county department. Plus, and this is particularly true of private counsel who might be hired as needed, knowledge of public health law is simply not common among attorneys. County attorneys have a multitude of other responsibilities calling for their attention. LawAtlas may allow the public health workforce to understand the law on their own. I foresee a world of educated, self-motivated public health lay practitioners making the life of the public health attorney a life of ease.

PHLN: What advice do you have for state and locals who want to create a similar database or collection of laws?

Klein: Get going on it fast. Others are already in line! I would involve a lawyer who has experience and understanding of your laws rather than throwing an intern to the wolves on the project. Start by dividing the law into subject matter potions that are less intimidating than the entire project. Remember to breathe.  Jurisdictions have their laws organized in a manner that made sense as the laws were codified, so that’s a starting point. Then look at the LawAtlas itself to see how it is set up (and Jenn indicated the structure may evolve with experience).Ideally, you could have an experienced attorney working alongside a JD-MPH candidate whom you later trick into continued employment.

PHLN: What other projects are you currently working on?

Klein: In the realm of things I can disclose, I am working on some educational matters related to Ebola-response lessons learned with the CDC PHLP to present at a National Association of County and City Health Officials (NACCHO) Summit; I serve on the Association of State and Territorial Health Officials’ (ASTHO’s) board of big-brained attorneys (I got on under the “big mouth” substitute exception); and I regularly communicate with attorneys, who know more than I do, at the Network for Public Health Law, as well as the aforementioned entities.

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

Klein: In an ideal world, I would hold elected office (my wife, Patte, served on the Lancaster County Planning Commission and was elected to the Lincoln, Nebraska, City Council, so I had a brush with greatness). Alternatively, I might be in the Rock and Roll Hall of Fame (I do play) or a starving musician. I can’t rule out prison (unjustly accused and convicted, of course).

PHLN: Have you read any good books lately?

Klein: The Walking Dead compendium. I’m really deep.

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

Klein: I have traveled to Europe and hope to return. Holland is next (my wife and I are both descended from Dutch folks from Groningen). I am amazed to see buildings, in use, that predate our nationhood.

PHLN: Do you have any hobbies?

Klein: I was a professional musician prior to and after law school. Still waiting to break on the national scene.

PHLN: Is there anything you would like to add?

Klein:  Cats! We didn’t talk about my cats, Kit, Roscoe, and Rowdy! Wait, I have pictures!

The first reader to correctly answer the quiz question will be given a mini public health law profile in the May 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: April 2016

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

Kerry Malloy Snyder, JD

Question: What state did Jennifer Ibrahim work with Darrell Klein on for the Public Health Laws Project?

Answer: Nebraska

Employment organization and job title:
Assistant Director of the Public Health and Tobacco Policy Center, a program of the Public Health Advocacy Institute at Northeastern University School of Law in Boston, Massachusetts

Brief job description: 
The Public Health and Tobacco Policy Center (Policy Center) provides policy support services for communities interested in improving public health through the implementation of evidence-based policies. I support the work of the Policy Center by providing legal and technical support for policies that reduce the availability of and market for tobacco products; reduce unwanted exposure to secondhand smoke; minimize tobacco advertising and promotion, increase cancer screening rates; improve HPV vaccination rates; and promote healthy behaviors. I work directly with public health staff, community educators, elected officials and other interested stakeholders to identify effective interventions addressing community public health concerns.

We primarily are funded through a contract with the New York State Department of Health to assist local New York communities in their pursuit of effective public health policies. We are affiliated with the Tobacco Control Legal Consortium at the Public Health Law Center and work together with our sister organizations to educate public health professionals and others about the latest tobacco control issues through webinars, conference presentations and the like.

Education:
JD, Suffolk University Law School

Favorite section of the News: 
My favorite section varies by edition. I enjoy the Public Health Law News because it covers so many different public health issues. While my own work is centered on tobacco control and cancer prevention, I like to keep abreast of other public health issues, and Public Health Law News gives me a snapshot of the “hot topics” every month, as well as legal tools recently used in pursuit of public health objectives.

Why are you interested in public health law? 
I’ve always been interested in health, generally. After deciding that my pre-med undergrad track wasn’t for me, I ended up concentrating in Health and Biomedical Law at Suffolk University Law School. At the time, I was working, involved in public policy as a state senate staffer, and intended to apply my law degree to public service; I was fortunate to eventually be able to combine my two professional interests into a public health policy career. I see public health law as a way to level the playing field and create/maintain healthy environments in which everyone can achieve their full health potential—thereby expanding other opportunities for wellbeing, such as better educational outcomes, healthy community engagement, and economic mobility.

What is your favorite hobby? 
When I’m not running around with my kids, I like to find a quiet moment to read or perfect my sewing and hand embroidery techniques!

Texas: Tax of non-settling tobacco companies does not violate Equal and Uniform Clause of the Texas Constitution
Hegar v. Texas Small Tobacco Coalition
Supreme Court of Texas
Case No 14-0747
Filed 04/01/2016
Opinion by Justice Don R. Willett

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Washington: Department of Health’s authority to regulate unauthorized practice of medicine extends to tattoo artists who use a laser device to remove tattoos
Arnold v. Department of Health
Court of Appeals of Washington, Division Three
Case No. 32055-3-III
Filed 03/31/2016
Opinion by Judge Kevin M. Korsmo

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Federal: University covered by official immunity against researcher’s tortious interference claims arising from research fraud investigation
Kumar v. George Washington University
United States District Court, District of Columbia
Case No. 15-120 (JDB)
Filed 03/31/2016
Opinion by District Judge John D. Bates

Quotation of the Month: Judge Kevin M. Korsmo

“[The Department of Health (DOH)], stringing together its authority to act with wire and duct tape, contends that any penetration of the skin constitutes the practice of medicine. Although the statutory authorization to regulate the use of medical devices could be clearer, we believe DOH has the better of the two arguments,” Judge Kevin M. Korsmo writing for the majority in Arnold v. Department of Health, Court of Appeals of Washington, Division Three, No. 3205-3-III, which held that the Washington Department of Health’s authority to regulate unauthorized practice of medicine extends to tattoo artists who use a laser device to remove tattoos.