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December 2013—Public Health Law News

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Public Health Law Program,
Office for State, Tribal, Local and Territorial Support,
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In this Edition

Announcements

Job openings with National Indian Health Board. The National Indian Health Board is seeking applicants for three career opportunities at their Washington, D.C. headquarters. The positions are 1) Director of Public Health Programs, 2) Tribal Health Care Reform Program Manager, and 3) Tribal Health Reform Policy and Program Associate. All positions are open until filled. Find more information and apply for the positions.


Blog post on Pandemic All-Hazards Preparedness Reauthorization Act. On December 11, 2013, the Network for Public Health Law published a blog post on the Pandemic All-Hazards Preparedness Reauthorization Act and its new proposed guidance pertaining to the voluntary temporary reassignment of federally funded state, tribal, and local public health department personnel during a public health emergency. Find more information and read the blog post written by Gregory Sunshine, J.D., fellow at CDC's Public Health Law Program.


Policy fellowship opportunity. The Ohio State University Center of Excellence in Regulatory Tobacco Science invites applications from people interested in obtaining a post-graduate research fellowship in tobacco regulatory policy. The 2–3 year training program is geared toward participants interested in an academic research career. Individuals with a J.D., Ph.D, or equivalent, preferably with research training in public health, public policy, or other population sciences, may apply. Applications are being accepted and are reviewed on a rolling basis. A position could begin as early as January 1, 2014. Find more information and apply for the fellowship. [PDF - 156KB]


2014 Public Health Law Conference. The 2014 Public Health Law Conference will take place October 16–17, 2014, in Atlanta, Georgia. The conference will gather public health and legal experts from across the country to examine and discuss today's critical challenges in public health law. Find more information about the conference and learn how to get the early bird registration rate.

Legal Tools

American Indian Constitutions. The Library of Congress has added 428 Native American documents containing constitutions, charters, and acts from the years 1830 to 1960. The collection contains constitutions from the 1800s produced by the Cherokee, Choctaw, Chickasaw, and Creek and constitutions and charters drafted after the 1934 Indian Reorganization Act. Find more information and access the newly available Native American documents.


Intergovernmental cooperation agreements map. State interlocal agreement acts allow local health departments (LHDs) to collaborate with other LHDs, agencies, and entities to provide health and other services. This resource from the Network for Public Health Law outlines the terms of these agreements for each of the fifty states. Find more information and access the map.


Interactive safe routes to school policy workbook. ChangeLab Solutions released Safe Routes to School District Policy Workbook designed to help school board members, administrators, students' families, and community members create and implement policies that support active transportation and Safe Routes to School programs. The workbook walks users through policy options to help customize a Safe Routes to School policy, which can be downloaded and used by individuals and communities. Find more information and access the interactive policy workbook.


Digitized collection of all weekly surveillance reports for reportable diseases. The University of Pittsburgh's Graduate School of Public Health, with funding from the Bill and Melinda Gates Foundation, has launched Project Tycho, a searchable database of the entire history of weekly National Notifiable Disease Surveillance Systems reports for the United States from 1888 to the present. Find more information and access Project Tycho.


Food Code 2013. The U.S. Food and Drug Administration (FDA) has released the Food Code 2013, a model for safeguarding public health and ensuring food is unadulterated and honestly presented when offered to consumers. It represents FDA's best advice for a uniform system of provisions that address the safety and protection of food offered at retail and in food services. The model is available for adoption by state, local, and federal jurisdictions. Find more information and access Food Code 2013.

Public Health Law News Quiz

In honor of this month's interview with Public Health Law News founder Frederic E. Shaw, M.D., J.D., the Public Health Law News is happy to announce the return of the Public Health Law News Quiz (Quiz). The first reader to correctly answer the Quiz question will be given a mini-public health law profile in the January 2014 edition of the News. Entries should be emailed to PHLawProgram@cdc.gov with "PHL Quiz" as the subject heading. Entries without the heading will not be considered. Good luck!


Public Health Law News Quiz Question December 2013

What was the name of the article jointly written by the two individuals featured in the April 2013 Profiles in Public Health Law?

Top Stories

Minnesota: 'Dental therapy' takes root where dentists are scarce in Minnesota
Minnesota Public Radio News   (12/09/2013)   Lorna Benson

In the past two years, Minnesota licensed 28 dental therapists, mid-level dental professionals
licensed to perform many basic dental procedures, which previously required a dentist. Minnesota and Alaska are the only two states allowing dental therapists.

Dental therapists, often hired to work in remote areas of the state where there are no dentists, must work under the supervision of a dentist, but are not required to have a dentist on site. Many groups opposed the new dental therapist licensing, arguing that the level of dental care would fall or that dentists would lose business.

"I know there was that kind of fear from the dental world that the care wouldn't be of the same level, but I really do think it is," said Emily Eggebrecht, a dentist at Children's Dental Services in Minneapolis.

Executive Director of Children's Dental Services, Sarah Wovcha, indicated the new provider option has helped her program immensely. Due to the newer, lower-paid practitioners, her organization is able to reduce the hourly payment for services by about $30.00 per hour. "This has really been a lifesaver for us. [The lower payments] ha[ve] a huge impact on our ability as a safety net provider to maintain our financial solvency," said Wovcha.

[Editor's note: Find more information and read Minnesota's dental therapy laws or learn more about Alaska's Dental Health Aid Therapist and law.]


National: Bill on drug compounding clears Congress a year after meningitis outbreak
New York Times   (11/18/2013)   Sabrina Tavernise

President Obama signed the Drug Quality Security Act (Act) on November 27, 2013, giving the U.S. Food and Drug Administration (FDA) more regulating and policing powers over compounding pharmacies, pharmacies that tailor-mix drugs for individual patients. The Act now requires compounding pharmacies to report issues to the FDA in addition to state regulations.

Compounders that mass-produce drugs may register as "outsourcing facilities" with the FDA and will be subject to quality control and oversight regulations, much like large drug manufacturers. Compounders who elect not to register as outsourcing facilities would not be subject to the new oversight and would continue operating under a narrower definition of compounding: mixing medicines for individual patients on the basis of a prescription, or making limited quantities ahead of a prescription.

The Act also creates a drug tracking system, which includes nationwide serial numbers and an electronic drug tracing mechanism, to prevent counterfeit and stolen drugs from entering the drug market.

The Act was written in response to the 2012 meningitis outbreak that killed 64 people and sickened 751. The source of the outbreak was traced to tainted drugs from a compounding pharmacy in Massachusetts.

Some groups feel that the law is too strenuous, even with the option not to register. The International Academy of Compounding Pharmacists (IACP) opposed the Act and said it "will without question result in patients' inability to obtain access to needed medication." The IACP also said the Act grants the FDA "sweeping, unprecedented authority in determining what pharmacies can compound."

One of the Act's authors, Iowa Senator Tom Harkin, has higher hopes the Act "will improve oversight of high-risk drug compounding."

[Editor's note: Find more information and read the Drug Quality Security Act.]

Briefly Noted

Alaska: Post-exposure rabies shots will no longer take such a bite of state budget
State of Alaska stops supplying free post-exposure rabies shots
Alaska Dispatch   (12/05/2013)   Laurel Andrews
[Editor's note: Find more information about rabies and post-exposure treatment.]


California: Los Angeles City Council puts e-cigarettes in same category as tobacco products
City council votes to regulate e-cigarette sales in L.A.
Los Angeles Times   (12/04/2013)   Catherine Saillant


California: Adult film industry faces potential third HIV-related shut down in 2013
Porn performer tests positive for HIV; industry group seeks shutdown
Lost Angeles Times   (12/07/2013)   Maisa Gerber


Kansas: Anti-tobacco advocates question state's tobacco prevention funding
Anti-tobacco advocates say Kansas has underfunded smoking prevention
Lawrence Journal World   (12/09/2013)   Giles Bruce
[Editor's note: Find more information and access the report, Broken Promises to Our Children, the 1998 state tobacco settlement 15 years later [PDF - 352KB], published by Campaign for Tobacco-Free Kids, American Heart Association, American Cancer Society Cancer Action Network, American Lung Association, the Robert Wood Johnson Foundation and Americans for Nonsmokers' Rights.]


Virginia: Sterilization law repealed in 1979, victims still seek compensation
Virginia under renewed pressure to give reparations for those sterilized under state law
Washington Post   (12/09/2013)   Frederick Kunkle


Wisconsin: State nursing homes largely compliant with federal sprinkler mandate
Most Wisconsin nursing homes meet mandate to boost fire safety
Journal Sentinel   (12/08/2013)   Lydia Mulvany


National: Newly insured speak with hope
Amid the uproar over the health law, voices of quiet optimism and relief
New York Times   (12/08/2013)   Abby Goodnough, Katie Thomas, and Reed Abelson


National: Newly approved hepatitis C drug eliminates weekly injections
FDA approves pill to treat hepatitis C
New York Times   (12/06/2013)   Andrew Pollack


National: Researcher hopes 2008 Consumer Product Safety Act will curb high chair falls
Rise in U.S. high chair injuries stuns experts
Philly.com   (12/09/2013)   Alan Mozes

Feature Profile in Public Health Law

Frederic E. Shaw, M.D., J.D.

Title: Senior Advisor for Health Reform, Office of Health System Collaboration, Office of the Associate Director for Policy, CDC

Organization: National Indian Health Board

Education: 
B.A., 1973, University of New Hampshire
M.D., 1977, University of Vermont College of Medicine
J.D., 1992, Columbia Law School


PHLN: What sparked your interest in public health?

Shaw: In 1980, I was working as an internal medicine resident at the University of Vermont when I learned of an opportunity to go to Thailand to provide care to Cambodian refugees. The Vietnamese had just invaded Cambodia, forcing thousands of these refugees into makeshift camps near the Thai border, and mortality was high. Within a few weeks, I was treating patients in a tent six kilometers inside Cambodia. I worked in the camp for three months, seeing patients with typhoid fever, malaria, dysentery, and other illnesses. We soon realized that many of these illnesses could be prevented, and we began a basic public health and hygiene program in the camp. That's when I first thought of working in public health. While working in the camp, I met several people from CDC. They told me about the Epidemic Intelligence Service (EIS). Three years later, when I finished my service in the National Health Service Corps, I applied to EIS.

PHLN: Few people have earned both doctor of medicine and juris doctorate degrees. Please describe your educational path and what inspired you to earn both degrees?

Shaw: I had been interested in medicine since I was about twelve years old. In the late 1980s, I was working as the state epidemiologist in New Hampshire when I became interested in the legal issues around the AIDS epidemic. I deferred going to law school for a couple of years, then entered Columbia Law School in 1989.

PHLN: How have you used your law degree in your public health law career?

Shaw: The legal training has allowed me to have a perspective that I would not have had otherwise. Law underpins almost everything we do in public health. My legal training has come in handy at many points in my career, for example when I worked in the U.S. Senate as a legislative assistant, and in my current position as CDC's Senior Advisor for Health Reform. 

PHLN: What was your career path to the position of Senior Advisor for Health Reform?

Shaw: I worked for a couple of years as the Associate Director for Science in the Division of Health Informatics and Surveillance. In October 2012, the health reform position became vacant unexpectedly when the previous advisor left CDC. I had to climb a steep learning curve on the Affordable Care Act (ACA), a very complex law, but I had some experience in health insurance and regulation from my days on Capitol Hill. Training in health law also helped.

PHLN: Your diverse background working in public health law, both within and without CDC, gives you a unique perspective on public health law. What are your thoughts on how public health law has evolved during your career?

Shaw: The study of public health law goes back a very long time, but it went through a modern renaissance in the last century through the work of James Tobey, and later, Frank Grad, Lawrence Gostin, Scott Burris, and many others. At CDC, public health law got more attention beginning with CDC-sponsored workshops in 1999–2000. The CDC Public Health Law Program was established in 2000. I first became associated with the program by attending weekly CDC law team meetings convened by Richard Goodman, Gene Matthews, and Tony Moulton. In 2003, I joined the program on a temporary detail, and then later took a permanent position there. Public health law was a "natural" for me because I was dually trained and I had experienced firsthand the crucial role of law in daily public health practice in the field.

The CDC program grew during the mid-2000s, gained more staff, published important works in the literature, expanded its technical and educational reach, held yearly national conferences, and had a big role in putting public health law more firmly on the map. Now, under the leadership of Matthew Penn, the program has expanded further. A couple of years ago, public health law expanded again at CDC with the establishment of the Law and Science Advisory Group, which has over 120 members across the agency.

In the last several years, support through the Robert Wood Johnson Foundation has had a big effect on public health law through its funding of programs such as the Network for Public Health Law, and Public Health Law Research. Other entities, such as the American Society of Law, Medicine & Ethics, also have made big contributions. 

PHLN: You founded the Public Health Law News in July 2003. What was your inspiration for the PHLN?

Shaw: My work at the CDC Public Health Law Program involved setting up a clearinghouse of information on public health legal preparedness. The PHLN was part of that. It began as a simple daily email to a few dozen people within CDC to help keep them informed about news, journal articles, and court cases in the field. After a while, it began circulating outside CDC and the number of subscribers skyrocketed. Later it became a weekly, and then a monthly publication. We never imagined the circulation would rise to what it is today, around 119,000.

PHLN: How has the PHLN changed in the past decade?

Shaw: Initially it was a very simple publication. When a newsletter comes out every day, you don't need a huge amount of content in each issue. Then, as it became a weekly, and then a monthly, it became longer and more elaborate. It's a great publication with a very important function.

PHLN: What kind of stories are important for the PHLN to cover and why?

Shaw: Somebody once told me that the News was needed to help create an "intentional community" of people interested in public health law. Yes, the purpose was partly to inform—to spread news and developments in the field—and to transmit information from CDC. But it also served to knit together like-minded people into a community built around public health law. It's important for the PHLN to continue doing that.

PHLN: What have been some of the most exciting public health law events you have observed and how have those events shaped your career?

Shaw: At the top of my list would be the enactment of the Affordable Care Act and the Supreme Court's decision in National Federation of Independent Business v. Sebelius. Those were major landmarks in the law and they are having far-reaching effects on public health. In addition, I would list some of the early public health law conferences put on by the CDC Public Health Law Program. They were very exciting, almost exuberant, because people were coming together for the first time in years to trade ideas and celebrate the huge potential of the subject.

PHLN: The influenza A (H1N1) pandemic in 2009 was a catalyst for public health law preparedness. What were your observations and what role did you play in addressing the pandemic?

Shaw: I was very involved because, at the time, I was editor of the MMWR. We published the first two cases of pandemic influenza A (H1N1) on April 21, 2009. In the next year or so, we published over forty-five articles on various aspects of the pandemic. Yes, the H1N1 pandemic was a catalyst for public health legal preparedness, but that had begun earlier with the SARS epidemic in 2003, in which the CDC Public Health Law Program played an important role.

PHLN: For the past six years you have taught public health law to students at Emory's Rollins School of Public Health. Can you describe your experience teaching public health law?

Shaw: It's been a great experience, as much for me as for the students. You never learn a subject so well as when you have to teach it. The vast majority of my students are masters-level students in health policy. Teaching law to masters-level public health students is much different from teaching to law students. Most of my students have no knowledge or background in law, the U.S. Constitution, or legal thinking. Many are from foreign countries. So, in my class we start with the basics: what law is, what it does, and how it is interpreted. I love it when students have an Aha! moment about the role of law in public health. 

PHLN: Of the valuable public health law principles you teach, which do you consider to be the most important?

Shaw: Federalism is the most important concept for masters-level students to understand, because it is so important to how public health works in the United States. In our country, legal power is divided, and often shared, between the federal government and the states. This makes public health practice much different in the United States than in many other countries.

PHLN: What are your current projects?

Shaw: For the past fourteen  months, I've served as the Senior Advisor for Health Reform in the Office of Health System Collaboration, Office of the Associate Director for Policy, CDC. I have truly enjoyed the work. My job is to understand the Affordable Care Act and its implications for CDC and for public health, to help translate the technicalities of the law, to provide technical assistance to public health professionals about the law and its likely effects, and to review ACA-related regulations on behalf of CDC. I work a lot with the Office for State, Tribal, Local and Territorial Support (OSTLTS) and other CDC programs, the Department of Health and Human Services, and CDC partner organizations. I also serve as Chair of CDC's Law and Science Advisory Group.

PHLN: What public health law projects would you be interested in working on in the future?

Shaw: In my current work in health reform, I've gotten very interested in how the insurance expansions of the ACA and the big transformation we are now seeing in health care delivery will affect local health departments. I have been working on this with OSTLTS and key CDC partners, and I plan to stay involved in that work. Another area of interest for me is the law of disease reporting. Over the past few years I had an opportunity to work on this subject with CDC and the Council of State and Territorial Epidemiologists, and I have found it to be a fascinating subject of study. There is a lot to learn about how these laws are constructed and how they operate. 

PHLN: Have you read any good books lately?

Shaw: I just finished reading three good books by Nathaniel Philbrick: Mayflower: A Story of Courage, Community, and War; In the Heart of the Sea: The Tragedy of the Whaleship Essex; and Bunker Hill: A City, a Siege, a Revolution. All three are about the history of New England, my native land.

Court Opinions

Michigan: Permits affirmed where proposed modifications lowered emissions
Sierra Club v. Department of Environmental Quality
Court of Appeals of Michigan
Case No. Nos. 308072, 314152
Filed 11/21/2013
Per curiam opinion


Michigan: Doctor owed no duty of care to patient in independent chiropractic evaluation
Bureau of Health Professions v. Serven
Court of Appeals of Michigan
Case no. 311939
Filed 12/03/2013
Opinion by Judge Michael J. Riordan


Federal: Private contractors reviewing gas storage had 'state action' status
Herman v. Harman
United States District Court for the Middle District of Pennsylvania
Case no. 3:13cv1118
Filed 12/02/2013
Opinion by Judge James M. Munley


Federal: Pharmacists used professional judgment refusing to refill pain medications
Brown v. CVS Pharmacy, LLC
United States District Court for the Middle District of Tennessee, Columbia Division
Case no 3:11-cv-0980
Filed 10/09/2013
Opinion by Judge Aleat A. Trauger

Quotation of the Month

Los Angeles, California City Councilman Paul Koretz

“It’s important to protect young people from this deadly habit and to protect people from second-hand smoke,” said Los Angeles, California City Councilman Paul Koretz of the city council’s recent vote to include e-cigarettes in the same category as tobacco products.

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