Regulating Wellness Through Employers: Mitigating the Knowledge Gap

Some of the behavioral changes that the Affordable Care Act seeks to bring about are prompted directly by the Act or a federal agency acting pursuant to the Act.  The “individual mandate” that people buy health insurance is one example; individuals who do not change their behavior to comply with that particular provision of the law are subject to a tax penalty imposed by the IRS.

But much of the work of the ACA is done through regulatory intermediaries that are themselves incentivized by the Act to find ways to bring about the end-user behavioral changes that the ACA is really after.  Medicaid expansion is a straightforward example–under the ACA the federal government does not provide insurance coverage to those who make less than 133% of the federal poverty line, rather, it incentivizes states to do so.  Accountable Care Organizations are another somewhat more roundabout example: the Act incentivizes doctors to form organizations that will themselves incentivize doctors to coordinate care and patients to obtain more value-maximizing services.

Like any principal-agent relationship, regulating through an intermediary has benefits and costs.  The intermediary (state, employer, insurer, doctor, etc.) may be differently positioned than the federal government to obtain information about, and influence the behavior of, the actors whose collective behavior we ultimately care about, for better or worse.  And certain intermediaries may be differently responsive to the concerns of those impacted by the policies they enact than the federal government, again for better or worse. Continue reading

Call for Abstracts: Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics & Tobacco Products

The Food and Drug Law Journal is pleased to announce a forthcoming symposium—Constitutional Challenges to the Regulation of Food, Drugs, Medical Devices, Cosmetics, and Tobacco Products—to be held at the Georgetown University Law Center (GULC) on Friday, October 30, 2015, and co-sponsored by the Food and Drug Law Institute and GULC’s O’Neill Institute for National and Global Health Law.

The deadline for submitting abstracts is June 1, 2015. Download more information about the symposium here.

What Happens When A Retail Pharmacy Decides To Stop Selling Cigarettes?

A new post by Andrew Sussman on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

The sale of cigarettes and tobacco products at retailers with pharmacies has received considerable attention over the past year. The national debate reignited in February 2014, when CVS/pharmacy announced that we would quit the sale of cigarettes and tobacco products in our 7,800 pharmacies nationwide. In September 2014, we announced we were officially tobacco free — one month earlier than planned. This was met with kudos from the media, public health officials, and even the President of the United States.

But one question that did not receive anywhere near that level of attention was whether or not our actions would make a difference in the prevalence of smoking and, ultimately, in the public health.

Read the full post here.

In Regulating E-Cigarettes, No Easy Fix For The FDA

A new post by Wendy Parmet on the Health Affairs Blog, as part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015.

Sometime in the next few months, the Food and Drug Administration (FDA) is expected to issue the so-called deeming regulations, which will open the door to the federal regulation of e-cigarettes. In considering whether to issue the regulations, which were first published for notice and comment rulemaking last April, the FDA faces a formidable challenge: it must decide whether and how to regulate in the midst of scientific uncertainty and limited statutory flexibility.

By subjecting e-cigarettes to its regulatory regime, the FDA risks retarding the growth of what may prove to be a powerful new tool for harm reduction. But by failing to act, the agency risks undermining decades of progress in tobacco control. In either case, the public health impact is apt to be significant.

Read the full post here.

Designing policy interventions in the context of obesity—what we can learn from the effects of cigarette taxes on children’s health

By Diana Winters (@diana3000)
[Cross-posted at HealthLawProf Blog.]

An important new study shows that a child will most likely be healthier throughout her childhood if a tax on cigarettes is in place when her mother is pregnant. Economist David Simon (who, full disclosure, is my cousin) at the University of Connecticut has extended the findings that the health of infants can be improved by a policy intervention that improves the in-utero environment, and has provided strong evidence that cigarette taxes can improve the health of children into their teen years.

It is well established that smoking during pregnancy can harm a developing fetus. In his paper, Simon cites studies that demonstrate the negative effects of taxes on cigarette smoking, and in a second paper, he collects and reviews the literature that shows that pregnant women are responsive to cigarette taxes. Simon uses a restricted-use version of the National Health Interview Survey, which the Centers for Disease Control and Prevention has used since 1957 to collect data on the health of the U.S. population, to examine medium-term childhood health outcomes for individuals exposed to a cigarette tax in-utero.  Continue reading

Public Health Trumps Corporate Speech

By David Orentlicher
[Ed Note: Cross-posted at HealthLawProfBlog.]

Reversing its previous deference to corporate speech interests, the U.S. Court of Appeals for the D.C. Circuit came down in favor of consumer protection in a July 29 decision. In American Meat Institute v. U.S. Dept. of Agriculture, the court upheld a federal government regulation requiring meat companies to disclose the countries of origin for their products. If your beef comes from Argentina or Canada, you will know that from its label.

More importantly, the court gave the Food and Drug Administration greater freedom to reduce tobacco use in the United States. In explaining its reasoning, the court repudiated the logic of an earlier decision by the court that rejected the FDA’s graphic warnings for cigarette packs. According to the meat labeling opinion, the cigarette warning decision did not allow sufficient leeway for the government to mandate warnings or other informational disclosures to consumers.

Perhaps the U.S. Supreme Court will restore the D.C. Circuit’s previous balance, but for now, the tide has turned in favor of the public’s health.

DUE 6/3: Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:  Continue reading

Call for Abstracts: Emerging Issues and New Frontiers for FDA Regulation

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The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Food and Drug Law Institute are pleased to announce an upcoming collaborative academic symposium:

Emerging Issues and New Frontiers for FDA Regulation

Monday, October 20, 2014 

Washington, DC

We are currently seeking abstracts for academic presentations/papers on the following topics:

  • Stem cell therapies
  • Nanotechnologies
  • Genetic (and biomarker) tests
  • Gene therapies
  • Personalized medicine
  • Comparative efficacy research
  • Drug resistant pathogens
  • Globalized markets
  • Tobacco
  • GMO
  • Bioterrorism countermeasures
  • Mobile health technologies
  • Health IT
  • Drug shortages
  • Other related topics

Abstracts should be no longer than 1 page, and should be emailed to Davina Rosen Marano at dsr@fdli.org by Tuesday, June 3, 2014. Questions should also be directed to Davina Rosen Marano.

We will notify selected participants by the end of June.  Selected participants will present at the symposium, and will be expected to submit a completed article by December 15, 2014 (after the event) to be considered for publication in a 2015 issue of FDLI’s Food and Drug Law Journal (FDLJ).  Publication decisions will be made based on usual FDLJ standards.

Research Round-Up: New Publications from the PHLR SciVal Experts Community

In honor of last week’s National Public Health Week, we have a lot of fresh, new PHLR. The latest crop of papers from public health law researchers touch on a number of important points and issues including transportation safety, implementation, tobacco control, and media presentation of public health law. Check out Scott Burris’s brief summaries after the jump!

Continue reading

Is CVS really doing the right thing?

By Deborah Cho

As announced earlier this month, CVS has decided to stop selling tobacco products in stores starting October 2014 because it is not in line with its goal of promoting health.  Since this announcement, there have been countless articles and editorials on whether this was a good move by CVS or not.  Those who have said that this is a good (or great) decision generally emphasize that it makes a powerful statement about the harmful health effects of smoking, while others have noted that CVS’s decision is an unwise financial move and is unlikely to actually decrease the rate of smoking in the country.

It was interesting that CVS chose October 1st as the official start date of its new initiative, as if it were signaling that it were a health entity coming into full compliance with the ACA and ready to herd in its customer-patients.  CVS has attempted to adopt the identity as a health provider, with its president hoping it evolves into an alternative to the doctor’s office.  As such, CVS must shed itself of anything that does not mesh properly with its new image.  This, however, inevitably leads to the question of why tobacco products were singled out as “unhealthy” when so many other products that are sold at drugstores like CVS provide just as little health benefit to the American population.

Continue reading

TOMORROW: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

1/31: Second Annual Health Law Year in P/Review

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

1/31: Second Annual Health Law Year in P/Review conference

Please join us for our second annual Health Law Year in P/Review event, co-sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine. The conference will be held in Wasserstein Hall, Milstein East C at Harvard Law School on Friday, January 31, 2014, from 8:30am to 5:00pm.

This year we will welcome experts discussing major developments over the past year and what to watch out for in areas including the Affordable Care Act, medical malpractice, FDA regulatory policy, abortion, contraception, intellectual property in the life sciences industry, public health policy, and human subjects research.

The full agenda is available on our website. Speakers are:  Continue reading

Petrie-Flom Intern’s Weekly Round-Up: 12/1-12/8

By Chloe Reichel

1) Following orders from FDA, 23andMe will no longer market genetic tests using health analyses. The company will, however, continue to sell genetic tests related to ancestry.

2) Families with children who have seizure disorders are flocking to Colorado. There, these children can legally receive medications containing extracts from marijuana, which are believed to reduce the occurrence of seizures.

3) A bill is being debated in the New York City Council that would ban the use of electronic cigarettes in public spaces. Supporters of the ban say that electronic cigarettes pose a public health risk, while opponents say that they are harmless.

4) Chemotherapy will not be forced on an Amish girl with lymphoblastic lymphoma. The family decided to stop treatment because of the side effects, and the court-appointed guardian of the girl has decided to drop the case against her parents because they are not locatable.

5) Error rates for those who filled out enrollment forms on the Healthcare.gov online insurance marketplace were at 25 percent for October, although representatives say that these error rates have since declined.

6) Legislators who are opposed to the Affordable Care Act are planning to utilize funds allocated by the federal government for Medicaid expansion to instead purchase private health insurance plans for people who are of low socioeconomic status. This Friday, Tom Corbett, governor of Pennsylvania announced this plan, and Arkansas legislators have already enacted an analogous plan.

ACA Final Rule on Wellness Plans

On May 29th, HHS issued the final rule governing wellness incentives in group health plans. While the incentives themselves are not a surprise, the scope they are given is worthy of ongoing attention. Wellness incentives have been controversial because of their potential for intrusion into individual choice, their subtle (or not so subtle) coerciveness, their valorization of a particularly model of health, and the possibility that they will impose differential burdens and costs on people with disabilities or other disfavored groups. The final rule attempts to meet these objections in several helpful ways.

Nonetheless, the final rule still will allow programs that are differentially burdensome as a result of factors other than health status. It will also allow programs under which it is more difficult for some than for others to obtain rewards because of their states of health. In programs that give rewards for health outcomes, alternatives must be available for those who do not meet targets—but the reasonableness standard for these alternatives permits requirements that may be differentially burdensome so if they are medically appropriate and follow the recommendations of the patient’s personal physician. HHS supports wellness programs as engaging individuals in their health, as encouraging them in healthy behaviors and discouraging them in unhealthy behaviors, and as incentivizing people to make use of recommended health care services such as screenings. Continue reading

Conference Announcement: Governance of Tobacco in the 21st Century

Governance of Tobacco in the 21st Century:
Strengthening National and International Policy for Global Health and Development

February 26-27, 2013
Harvard University, Cambridge, MA, USA

Keynote Speakers:
Dr. Nkosazana Dlamini-Zuma
Chairperson, African Union Commission
Dr. Margaret Chan
Director-General, World Health Organization

How do international laws and institutions regarding tobacco, trade, investment, agriculture and economic development intersect? What are the implications for global tobacco control efforts? How should public health concerns be taken into account in international economic policymaking? What is the proper balance between a government’s obligations to protect the health of its citizens and other international agreements to which it has subscribed? What are the broader implications for global governance and for global health?

This conference will bring together representatives from governments, intergovernmental organizations, civil society, business, and academia to explore these questions with the objective of:

  • Enhancing knowledge, information-sharing, network-building and learning across countries, contexts and policymaking arenas
  • Identifying strategies to strengthen the governance of tobacco at national and international levels;
  • Fostering greater policy coherence among actors working in health, trade and investment to ensure the protection of global health

The conference is being hosted by the Harvard School of Public Health’s Center for Global Tobacco Control and the Harvard Global Health Institute’s Forum on Global Governance for Health, with advice and support from the World Health Organization’s Tobacco-Free Initiative.

Additional support is provided by: American Legacy Foundation; American Cancer Society; the International Development Research Centre Canada; Campaign for Tobacco-free Kids; Harvard Law School; Framework Convention Alliance; O’Neill Institute for National and Global Health Law, Georgetown University; Institute for Global Tobacco Control, Johns Hopkins University; International Tobacco Control Policy Evaluation Project, University of Waterloo, Canada; Southeast Asia Tobacco Control Alliance (SEATCA).

Additional information is available here.  Registration is required.