Health Care Sharing Ministries (HCSMs) after Tax-Penalty Repeal

By Aobo Dong

The passage of the Republican tax reform bill affects the health care industry in ways that might be confusing and unpredictable for tens of millions of Americans. Due to political rhetoric and inaccurate portrayal of the bill, it seems as if the Individual Mandate – an essential element in the ACA – has been fully repealed. Nonetheless, as Health Affairs rightly points out, Section 5000A still remains in the statute to require “minimal essential coverage” for all individuals. Therefore, although the tax bill repealed the tax penalty for not having insurance coverage, the law still technically mandates individuals to acquire health insurance. Moreover, the tax penalty repeal will not take effect until the 2019 tax year, so individuals who are uninsured for more than 2 months in the 2018 tax year may still be liable for paying the tax penalty, unless future laws and regulations, or an executive order from Trump, indicates otherwise.

Under the new regulatory landscape, what could be some potential repercussions for Health Care Sharing Ministries (HCSMs)? These ministries, largely run by evangelical Christians who believe in the merit of private cost sharing, have been benefiting from the Individual Mandate since the inception of the ACA. Under Section 5000A, HCSM members are exempt from paying the tax penalty. The dearth of legal exemptions available and the widespread dislike of Obamacare among white evangelical communities in America likely fueled the rapid growth of HCSMs in recent years. Members pay their monthly “shares” to each other to cover health insurance expanses, without going through a central insurance or governmental agency for redistribution. Continue reading

Searching For Stability: The Political Future Of The Affordable Care Act

This new post by Benjamin Sommers and John McDonough appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

Efforts to repeal and replace the coverage expansions in the Affordable Care Act (ACA) as well as the tax increases that financed them were persistent throughout 2017. Even after the congressional Republicans’ highly visible failures earlier this year, they kept coming back—finally succeeding in zeroing out the penalties in the ACA’s individual mandate as part of federal tax cut legislation signed into law in late December.

Of keen interest and importance now is the question: What’s next for the ACA?

Originally, many ACA supporters assumed during the years of the Obama administration that once the law’s major coverage provisions took effect in January 2014, the reality on the ground of a successful coverage expansion and broader insurance benefits would transform the ACA into a popular program—growing in acceptance and inevitability as Social Security, Medicare, and Medicaid all did before it. […]

Read the full article here!

With The Federal Individual Mandate Gone, States Might Step Up: Lessons From Massachusetts

This new post by Audrey Morse Gasteier appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

The effective repeal of the federal individual mandate represents one of the most significant changes to the Affordable Care Act (ACA) since its implementation. Especially on the heels of the federal government’s sudden withdrawal of cost-sharing reduction payments this past October, the instability that the federal mandate repeal could introduce to health insurance markets is material. However, states can craft reaction strategies to protect against such effects.

In Massachusetts, where I manage policy and strategy for the state-run insurance exchange, we’ve now spent a decade administering our own state-based individual mandate. And, while our state is unique in many ways—our experience may prove useful to policy makers in other states considering locally tailored pathways to maintaining coverage gains. State-administered mandates or alternative policies to encourage broad coverage across a state’s population can be a tool to foster premium stability and healthy issuer participation, but we have found that mandates can also introduce extra advantages such as the promotion of consistent benefit floors and enabling effective outreach to the uninsured. […]

Read the full article here!

Solitary Confinement: Torture, Pure and Simple

Cross-posted from the Psychology Today blog, where it originally appeared on January 15, 2018. 

By Gali Katznelson and J. Wesley Boyd

Let’s call it for what it is: Placing prisoners in solitary confinement is tantamount to torture and it needs to stop.

The practice of placing incarcerated individuals in solitary confinement dates back to the 1820s in America when it was thought that isolating individuals in prison would help with their rehabilitation. Yet, over the past two centuries, it has become clear that locking people away for 22 to 24 hours a day is anything but rehabilitative. Solitary confinement is so egregious a punishment that in 2011, the U.N. Special Rapporteur on Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment condemned its use, except in exceptional circumstances and for as short a time as possible, and banned the practice completely for people with mental illnesses and for juveniles.

Despite its barbarity, the United States continues to place thousands of people, including individuals with mental illnesses and children, in solitary confinement, sometimes for decades. Thirty years ago, Dr. Stuart Grassian, who recently spoke at Harvard Medical School’s “Behind Bars: Ethics and Human Rights in U.S. Prisons” conference, evaluated 14 individuals placed in solitary confinement and found the same symptoms in many of them: hypersensitivity to external stimuli; perceptual disturbances, hallucinations, and derealisation experiences; affective disturbances, such as anxiety and panic attacks; difficulties with thinking, memory and concentration; the emergence of fantasies such as of revenge and torture of the guards; paranoia; problems with impulse control; and a rapid decrease in symptoms immediately following release from isolation. Taken together, Dr. Grassian proposed that these symptoms amount to a pathopsychological syndrome.

Continue reading

Crimes of Passion: New Neuroscience vs. Old Doctrine

Crimes of Passion: New Neuroscience vs. Old Doctrine
February 14, 2018 12:00 PM
Wasserstein Hall, Milstein West (2019)
Harvard Law School, Cambridge, MA

On Valentine’s Day we celebrate love. But the criminal law often sees love and passion turned into violence. How does this happen? And how should law respond? Many doctrines, most notably the “heat of passion” defense – which historically has been used disproportionately to excuse the crimes of men against women – rely on a distinction between defendants who acted “emotionally” instead of “rationally.” But modern neuroscience has debunked the idea that reason and emotion are two entirely different mental states. This panel will explore how law should respond to this neuroscientific challenge to long-held doctrine.

Panelists:

  • Lisa Feldman-Barrett, PhD, University Distinguished Professor of Psychology and Director of the Interdisciplinary Affective Science Laboratory at Northeastern University; Research Scientist, Department of Psychiatry, Northeastern University; Research Neuroscientist, Department of Radiology, Massachusetts General Hospital; Lecturer in Psychiatry, Harvard Medical School; Faculty Affiliate, the Center for Law, Brain & Behavior, Massachusetts General Hospital
  • Judge Nancy Gertner (ret.), Senior Lecturer on Law, Harvard Law School and Managing Director, Center for Law, Brain & Behavior, Massachusetts General Hospital
  • Moderator: Francis X. Shen, PhD, JD, Senior Fellow in Law and Applied Neuroscience, the Petrie-Flom Center in Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the Center for Law, Brain & Behavior at Massachusetts General Hospital; Associate Professor of Law and McKnight Land-Grant Professor, University of Minnesota Law School; Executive Director of Education and Outreach, the MacArthur Foundation Research Network on Law and Neuroscience

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Zack Buck on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

We welcome back our good friend Zack Buck, Professor of Law and Wilkinson Junior Research Professor at the University of Tennessee College of Law. He teaches bioethics and public health, torts, health care finance and organization, health care regulation and quality, and fraud and abuse. He is producing cutting edge  research on the relationship between reimbursement systems and  healthcare price and cost issues.

Our conversation includes some compelling “lightning” stories, including wellness plans, Maryland’s potential state mandate, the Health Affairs retirement of the great Tim Jost, and Medicaid work requirements. Then Zack demonstrated his true mettle, answering questions about MACRA/MIPS, value bundle reimbursement models, and state law attempts to reel in drug costs.

On that last topic: past show guests Aaron Kesselheim and Ameet Sarpatwari will be speaking at Maryland Law on March 8th, along with other health policy superstars; more details to come!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Turning the Right to Health into the Lived Reality for Everyone: The Framework Convention on Global Health Alliance

By Martin Hevia

Over the past few years, more and more global health luminaries and leading NGOs have called for a Framework Convention on Global Health (FCGH), for using the strongest instrument of international law to advance the quest for health equity.

In the globalization era, the highest attainable level of health cannot be achieved by States acting on their own. A FCGH treaty would facilitate the coordinated global effort needed to achieve the highest attainable level of health everywhere. It would reform global governance for health to enhance accountability, transparency, and civil society participation and protect the right to health in trade, investment, climate change, and other international regimes, while catalyzing governments to institutionalize the right to health at community through to national levels.

The FCGH Alliance membership includes more than 30 organizations and individuals from Africa, Asia, Latin America, North America, and Europe that believe that unconscionable global and local health inequities are fundamentally unjust.

We know this is an ambitious undertaking, but we are convinced that a FCGH would be a historical shift in global health.

For more info, please visit Here are some articles on the idea of an FCGH.

The Next WHO Director-General’s Highest Priority: A Global Treaty on the Human Right to Health (Lancet Global Health, 2016) (pdf)
http://www.thelancet.com/pdfs/journals/langlo/PIIS2214-109X(16)30219-4.pdf

A Vote for the World’s Health, Absent From the Headlines (DevEx, 2016)
https://www.devex.com/news/opinion-a-vote-for-the-world-s-health-absent-from-the-headlines-89129

An Independent Review and Accountability Mechanism for the Sustainable Development Goals: The Possibilities of a Framework Convention on Global Health (Health and Human Rights Journal, 2016) (pdf)
https://cdn2.sph.harvard.edu/wp-content/uploads/sites/125/2016/06/Friedman1.pdf

Towards a Framework Convention on Global Health: A Transformative Agenda for Global Health Justice (Yale Health Policy, Law, and Ethics, 2013)
http://digitalcommons.law.yale.edu/yjhple/vol13/iss1/1/
 
A Framework Convention on Global Health: A Catalyst for Justice (WHO Bulletin, 2012) (pdf)
http://who.int/bulletin/volumes/90/12/12-114371.pdf

Whither Private Health Insurance Now?

This new post by Wendy Mariner appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

Congress has been busy enacting and proposing changes to the Affordable Care Act (ACA)’s regulation of private health insurance, from repealing the tax on individuals without minimum essential coverage to the Alexander-Murray bill intended to shore up the private market. These changes do not play well together. Three reasons are explored here: the great wall, which divides advocates with different goals; whipsawed insurance markets, in which insurers are simultaneously pulled in different directions; and, of course, the cost of care, which each reform shifts onto different entities.

The Great Wall

A great ideological wall makes it almost impossible to reach national consensus on whether or how to regulate private insurance markets. The wall divides people—especially in Congress—who believe in personal responsibility for one’s health care costs from those who believe in social responsibility for many such costs or social solidarity. The former believe that you are responsible for your own health and you should be free to buy (or not buy) health care and health insurance as you choose. In this view, health insurance is a commercial product that is properly priced according to actuarial risk. Ideally, competition among insurers can produce affordable products of reasonable quality.

Those who favor in social responsibility for health care believe that health depends on more than personal behavior; it depends on the social determinants of health, including education, income, occupation, housing, and environmental factors. This view recognizes that illness is not always predictable and millions of people cannot afford needed health care. (Many also believe that access to health care is a human right as set forth in the Universal Declaration of Human Rights.) In this view, insurance is not a commodity, but a method of financing health care that should be available to all in need, and therefore a social responsibility. To enable everyone to have access to affordable care within a private market, government must regulate private insurers (and providers) more extensively than would be necessary in a public insurance system. […]

Read the full article here!

The Individual Insurance Market In 2018: Business As Usual?

This new post by Joseph Antos appears on the Health Affairs Blog as part of a series stemming from the Sixth Annual Health Law Year in P/Review event held at Harvard Law School on Tuesday, December 12, 2017.

Congress has enacted a tax bill that repeals the Affordable Care Act (ACA) penalties for individuals who fail to enroll in health insurance. Open enrollment for the 2018 plan year may stay roughly even with 2017 exchange enrollment—lackluster performance that some blame on what they call “Trump sabotage”. Some Republicans are urging Congress to appropriate funds for cost sharing reduction (CSR) payments and a national reinsurance pool, presumably to promote enrollment and moderate premium increases. Will Democrats vote to resolve the CSR problem and reinstitute reinsurance—policies many say they support? Or will it be business as usual on Capitol Hill with strict party-line votes (and the inevitable failure of ACA fixes)? Would that change anything about the way the nongroup insurance market operates next year?

The short answers are no, yes, and no. Here are some thoughts about why the status quo is likely to remain largely undisturbed by political speech-making and over-reaction from the editorial pages. My comments are based loosely on my presentation at the Petrie-Flom Health Law Year in P/Review conference held at Harvard University on December 12, 2017.

Exchange Enrollment For 2018

Early reports showed a more rapid pace of exchange enrollment this year than last.  As of December 15, 2017, 8.8 million people in the 39 states using the federal exchange had selected plans. That is less than last year’s total of 9.2 million enrollments through Healthcare.gov, but not the dramatic reduction that advocates may have expected. […]

Read the full article here!

REGISTER NOW! Future Directions for Laboratory Animal Law in the United States

Future Directions for Laboratory Animal Law in the United States
January 26, 2018
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Please join the ILAR Roundtable, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, and the Animal Law and Policy Program at Harvard Law School for a one-day meeting to discuss the future of animal law.

This event is free and open to the public, but registration is required. The workshop will also be webcast and will be accessible to all who are interested. Register now!

This event is cosponsored by the Institute for Laboratory Animal Research in the National Academies of Sciences, Engineering, and Medicine; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; and the Animal Law & Policy Program at Harvard Law School. 

Colorado Supreme Court Hears Important Case Re Constitutional Issues on Dispute About Frozen Preembyros – My Take on Oral Argument

By I. Glenn Cohen

On Tuesday, January 9th, the Colorado Supreme Court heard oral argument in In Re Marriage of Rooks. (Kudos to them for live streaming and archiving!)

This is the latest of a series of cases involving disputes between ex husbands and ex wives (or in some cases unmarried former partners) regarding the disposition of cryopreserved pre-embryos. These cases, that have been percolating in a large number of states for what has now been 25 years (!) and have come out in a myriad of ways on a myriad of theories as Eli Adashi and I recently detailed in the Hastings Center Report.

One thing many of these cases have in common, though, is that the Courts have avoided reaching the fundamental federal Constitutional question I wrote about now 10 years ago in the Stanford Law Review: Does the party opposing the implantation of embryos upon dissolution of the marriage have a right not to procreate recognized by the federal Constitution? I have argued that we need to realize we are talking about possible rights (plural) not to procreate and in particular separate out:

The right to be a gestational parent The right not to be a gestational parent
The right to be a genetic parent The right not to be a genetic parent
The right to be legal parent The right not to be a legal parent.

This case demonstrates well why such a distinction is important.

Continue reading

Bioethicist Art Caplan: A New Mind-Body Problem

A new piece by Bill of Health contributor Arthur Caplan, with Lisa Kearns, in The Hastings Center Bioethics Forum:

Not since Rene Descartes gazed from his garret window in early 17th-century Paris and wondered whether those were men or hats and coats covering “automatic machines” he saw roaming the streets has the issue of personal identity and your cranium been of such import. Descartes feared a world that he alone occupied due to deception by the devil. Today we face a different mind-body challenge in the form of a devil we know: Italian neuroscientist Sergio Canavero. He recently announced that the first human head transplant is imminent.

For bioethicists, the moral critiques of this surgery practically write themselves: Are we merely our bodies? How can a person so ill as to wish to trade in his lifelong corporeal companion be considered competent to consent to such a drastic procedure? How can family members consent to donate a body that they could very well run into — and recognize — at the beach or gym? What if a left-handed person received a right-handed body? What if a lifelong Chicago Bears fan woke to find himself attached to the green-and-gold-tattooed torso of a former Packers fan? Would transplant recipients need to buy whole new wardrobes? Who will pay? […]

Read the full article here!

Paul Osterman on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

This week’s pod features labor economist Paul Osterman, Professor of Human Resources and Management at the MIT Sloan School of Management. His research concerns changes in work organization within companies, career patterns and processes within firms, economic development, urban poverty, and public policy surrounding skills training and employment programs.

His most recent book is “Who Will Care For Us: Long Term Care and the Long Term Workforce,” which is the basis for our discussion. Paul digs deep, exposing a byzantine non-system of care for the elderly and disabled. (This week’s episode complements our earlier engagements with eldercare in the work of political scientist Laura Katz Olson (Episode 98) and law professor Allison Hoffman (Episode 73).

He offers a nuanced and multifaceted program for improving the lives of both the disabled in need of care, and the workers who provide that care. He argues that the expansion of the role of direct care workers, including more and better training for them, “will save the system money, both by obtaining better health outcomes—thereby reducing visits to emergency rooms, hospitals, and nursing homes—and by shifting some tasks to lower-paid occupations.” Our discussion covers the demographics of care workers, scope of practice issues, the role of Medicare and Medicaid, possible technological innovations, and quality regulation.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Medical Abortions and the Internet

by Clíodhna Ní Chéileachair

Early last summer, Facebook removed Women on Web’s page for ‘promoting drug use’. The Amsterdam-based organization connects women with doctors who prescribe the pills necessary for medical abortions and provides information on taking abortion pills, on contraception and on accessing abortion services in states where access to safe abortions is restricted or illegal. This followed an earlier interaction in which Facebook removed a photo of the organization’s founder, Rebecca Romperts, superimposed with instructions on the use of the pills. Facebook later apologized and reinstated the Facebook page, claiming that the removal was an error, and that the page served Facebook’s function of allowing individuals to organize and campaign for the issues that matter most to them.

Leaving aside the question of whether it was indeed an error, WoW have never existed without controversy. In February of last year, their sister organization Women on Waves made headlines when their boat was detained by the Guatemalan authorities while campaigning in Guatemalan waters. Women on Waves provides medical abortions to women once they are in international waters and thus operating under Dutch law, which allows abortions up to 21 weeks. Both organizations will provide access to abortion services up to 9 weeks, using a combination of medicines – misoprostol and mifepristone – which together induce abortion. The WHO estimates that the drug combination is used by 26 million women globally per year and is recommended as an abortifacient up to 9 weeks of pregnancy. Women on Waves are one of many organizations that aim to allow women to access abortion services that are either explicitly illegal, or practically unavailable in their home countries. There are risks associated with taking the drug combination, but these are minimal, and far riskier is the danger of leaving women with access to illegal abortions which is often the reality of full abortion bans. In Guatemala, 65,000 women have illegal abortions every year, with a third of that number admitted to hospitals from complications associated with the backstreet procedure. A medical abortion before 10 weeks is safer than childbirth, and as safe as a natural miscarriage. Both drugs have been on the WHO’s list of essential medicines since 2005. Studies show a high level of effectiveness in self-sourced and administered abortion pills, such as the service offered by Women On Web, and outcomes generally compare favorably with in-clinic administration. Underscoring the importance of safe access to the drug combination, use of the pills is often studied as a self-administration method alongside getting punched in the stomach, taking herbs or homeopathic medicines, deliberately taking a high dose of hormonal pills, alcohol and illegal drugs.

Continue reading

Slightly Hazy: An Insurer’s Emergency Room Policy Draws Congressional Scrutiny

By Oliver Kim

Last year, I had the good fortune to present at the Petrie-Flom Center’s conference on transparency and I started with an anecdote about a congressman who decided to wait rather than take his son immediately to the emergency room after he injured himself. The congressman assumed his son only had a sprain, but he had actually broken his arm. So why the wait? Because of a difference in his co-pay. In an interview, the congressman argued for policies to push consumers to understand—and be exposed to— healthcare costs in order to make better decisions about their care: “Way too often, people pull out their insurance card and they say ‘I don’t know the difference or cost between an X-ray or an MRI or CT Scan.’ I might make a little different decision if I did know (what) some of those costs were and those costs came back to me.”

The congressman’s policy prescription is becoming reality: last year, the largest Blue Cross Blue Shield plan Anthem announced a new policy where it would deny coverage for care provided in an emergency room that was later deemed non-emergent (except in certain circumstances). It seems a far cry from simply charging an ER co-pay, but Anthem argues it has seen a rise in non-emergency care being provided in emergency rooms. How are patients supposed to know if the ache or pain they are experiencing is not an emergency? Apparently there is a spreadsheet of over 1,900 ailments that Anthem considers non-emergent.

Continue reading

Introducing Blogger Oliver Kim

The Petrie-Flom Center is pleased to welcome Oliver Kim to the Bill of Health as our newest contributor!

Oliver is an adjunct professor with the University of Pittsburgh School of Law and a policy consultant in Washington, DC. He has over fifteen years of federal and state legislative and policy experience, including serving for eight years as a senior advisor to Senator Debbie Stabenow (D-MI) and two as deputy director for the Special Committee on Aging under Chairman Bill Nelson (D-FL). He was selected for the Woodrow Wilson foreign policy fellowship, the AcademyHealth Health Policy in Action award, the Hartford Foundation Change AGEnt program, and the American Council of Young Political Leaders’ international exchange program. He received his BA from Indiana University, JD from University of Minnesota, and LLM from the Georgetown University Law Center.

Representative publications:

  • Lois Magner and Oliver Kim. A History of Medicine (2018, 3rd ed.).
  • Oliver Kim, “Ebbs and Flows: Issues in Cross-Border Exchange and Regulation of Health Information,” 26 Annals of Health Law 39 (Winter 2017).
  • Oliver Kim, “Trying and dying: Are some wishes at the end of life better?” 7 Rutgers Journal of Bioethics 37 (Spring 2016).
  • Oliver Kim, “When Things Fall Apart: Liabilities and limitations of compacts between state and tribal governments,” 26 Hamline Law Review 49 (2003).
  • Oliver Kim, “The Driver’s Privacy Protection Act: On the Fast Track to National Harmony or Constitutional Chaos?” 84 Minnesota Law Review 223 (1999).

Welcome, Oliver!

REGISTER NOW! Will Value-based Care Save the Health Care System?

Will Value-based Care Save the Health Care System?
March 2, 2018 9:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Value-based health care is one of the most pressing topics in health care finance and policy today. Value-based payment structures are widely touted as critical to controlling runaway health care costs, but are often difficult for health care entities to incorporate into their existing infrastructures. Because value-based health care initiatives have bipartisan support, it is likely that these programs will continue to play a major role in both the public and private health insurance systems. As such, there is a pressing need to evaluate the implementation of these initiatives thus far and to discuss the direction that American health care financing will take in the coming years.

To explore this important issue, the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics is collaborating with Ropes & Gray LLP to host a one-day conference on value-based health care. This event will bring together scholars, health law practitioners, and health care entities to evaluate the impact of value-based health care on the American health care system.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School with support from the Oswald DeN. Cammann Fund and Ropes & Gray LLP.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of December. The selections feature topics ranging from the benefits, limitations, and value of abuse-deterrent opioids; to PDUFA VI; to Medicare formulary restrictions for prescription opioids. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Curfman GD, Beletsky L, Sarpatwari A. Benefits, Limitations, and Value of Abuse-Deterrent Opioids. JAMA Intern Med. 2017 Dec 11. [Epub ahead of print]
  2. Darrow JJ, Beall RF, Kesselheim AS. Will inter partes review speed US generic drug entry? Nat Biotechnol. 2017 Dec 8;35(12):1139-1141.
  3. Darrow JJ, Avorn J, Kesselheim AS. Speed, Safety, and Industry Funding—From PDUFA I to PDUFA VI. N Engl J Med. 2017 Dec 7;377(23):2278-2286.
  4. Dave CV, Hartzema A, Kesselheim AS. Prices of Generic Drugs Associated with Numbers of Manufacturers. N Engl J Med. 2017 Dec 28;377(36):2597-2598.
  5. Hwang TJ, Darrow JJ, Kesselheim AS. The FDA’s Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016. JAMA. 2017 Dec 5;318(21):2137-2138.
  6. Miller JE, Wilenzick M, Ritcey N, Ross JS, Mello MM. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ Open. 2017 Dec 5;7(12). [Epub ahead of print]
  7. Pinnow E, Amr S, Bentzen SM, Brajovic S, Hungerford L, St George DM, Dal Pan G. Postmarket Safety Outcomes for New Molecular Entity (NME) Drugs Approved by the Food and Drug Administration Between 2002 and 2014. Clin Pharmacol Ther. 2017 Dec 20. [Epub ahead of print]
  8. Samuels EA, Ross JS, Dhruva SS. Medicare Formulary Coverage Restrictions for Prescription Opioids, 2006 to 2015. Ann Intern Med. 2017 Dec 19;167(12):895-896.

Zombie Ideas: Safe Injection Department

Recently, people in Vermont have been talking about launching a Safe Injection Facility (SIF) to address drug harms arising with the opioid epidemic. With more deaths than ever, trying new approaches make sense — especially “new” approaches like SIFs that have two decades of solid international evidence of efficacy behind them.  Several cities are actively considering the same intervention.

One of the biggest barriers is uncertainty about how federal drug control authorities will react.  Although there are reasonable arguments that SIFs for public health do not violate the Controlled Substances Act, and the national opioid task force has broadly called for extraordinary action, there has been no explicit support from the Trump administration and no effort to carve out space in the law from Congress. Continue reading

House of Commons Report: Managing the Costs of Clinical Negligence in NHS Hospitals

By John Tingle

The House of Commons Committee of Public Accounts (Committee of Public Accounts) has recently considered the issue of managing the increasing clinical negligence costs in NHS (National Health Service) hospitals in a report. They make a number of important recommendations as well as putting into the spotlight a number of developing trends and themes. The report is linked to a report recently published by the National Audit Office on managing clinical negligence costs.This report is closely examined by the Committee with witnesses giving oral and written evidence.

The high cost of clinical negligence litigation

The report begins with a statement on the high and increasing cost of clinical negligence which sets the scene and tone for the rest of the report The Committee has raised concerns about the rising costs of clinical negligence on a number of previous occasions going back as far as 2002. The questions and answers of witnesses called by the Committee do reveal some very interesting and telling insights into the issues and the problems faced. Continue reading