Is Mike Pence’s Medicaid Expansion a Blueprint for Donald Trump’s Health Care Reform?

By David Orentlicher

[cross-posted at orentlicher.tumblr.com]

Donald Trump’s pledge to repeal and replace the Affordable Care Act has looked much more like a plan for repeal than a plan to replace, especially in light of the kinds of reform proposals advanced by leading Republicans in Congress, including Trump’s designee for Secretary of HHS, U.S. Rep. Tom Price.

But Trump’s recent promise of “insurance for everybody,” suggests that he might actually have a serious replacement in mind. While we cannot automatically take Trump at his word, it may be the case that he is following the example of his Vice President-elect Mike Pence, who as Governor of Indiana defied Republican positioning in signing on to the Affordable Care Act’s Medicaid expansion. Continue reading

Tim Jost on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

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This week we are honored to have a conversation with Professor Tim Jost from Washington & Lee School of Law. Jost, one of our most prolific scholars and astute commentators, not to mention the rock around which the Health Affairs blog is built, looks back at the successes and failures of the ACA, speculates on some of the reasons for its rocky road, and looks ahead to repeal and replacement.

Jost’s posts at Health Affairs are more urgent than ever as the uncertainty around ACA repeal/replace/delay intensifies. While his work on consumer-directed health care is particularly relevant to today’s policy environment, he has also proposed reforms to strengthen the ACA.

For some notes on items we discussed: Frank mentioned an analysis of Tom Price’s plan to replace the ACA, focusing on the plan to “block grant $1 billion dollars a year for four years (or $2.2 million per Congressional District per year) to help states fund high risk pools.” Jost mentioned a Commonwealth Fund report suggesting that amount is not even within two orders of magnitude of the true cost of such pools (at least $100 billion). But at least some people will truly benefit from ACA repeal: the 400 highest-income households each “would get an average tax cut of about $7 million a year,” according to CBPP.

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 iTunes, listen at Stitcher Radio, Tunein and 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

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda

8:30 – 9:00am, Registration

A continental breakfast will be available.

9:00 – 9:05am, Welcome Remarks

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School
  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

9:05 – 10:30am: The End of ObamaCare? Health Care Reform Under A New Administration

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • David Blumenthal, President, The Commonwealth Fund
  • Michael K. Gusmano, Research Scholar, The Hastings Center
  • John McDonough, Professor of the Practice of Public Health, Director of the Center for Executive and Continuing Professional Education, Harvard T. H. Chan School of Public Health
  • Abigail R. Moncrieff, Associate Professor of Law and Peter Paul Career Development Professor, Boston University School of Law
  • Moderator: Einer Elhauge, Caroll and Milton Petrie Professor of Law and Founding Faculty Director, Petrie-Flom Center, Harvard Law School

10:30 – 10:45am, Break

10:45 – 11:10am, Precision Medicine Initiative/Cancer Moonshot

11:10 – 11:35am, Common Rule Update

  • Holly Fernandez Lynch, Executive Director, Petrie-Flom Center and Faculty, Center for Bioethics, Harvard Medical School

11:35am – 12:00pm, Clinical Trial Data Sharing

  • TBD, MRCT Center at Harvard

12:00 – 12:25pm, All-Payer Claims Databases

  • Gregory D. Curfman, Editor-in-Chief, Harvard Health Publications, Harvard Medical School

12:25 – 1:00pm, Lunch

Lunch will be provided.

1:00 – 1:25pm, Defining Death, Aid in Dying, and Family Rights

  • Paul Ford, Lecturer, Harvard Medical School, Winter 2017; Director, NeuroEthics Program, Cleveland Clinic; Director of Education, Department of Bioethics, Cleveland Clinic; Associate Professor, CCF Lerner College of Medicine of CWRU

1:25 – 1:50pm, Patient Advocacy, FDA, and Right to Try

  • Jerry Avorn, Professor of Medicine, Harvard Medical School and Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital

1:50 – 2:15pm, Drug Pricing and Cost

  • Ameet Sarpatwari, Instructor in Medicine, Harvard Medical School and Brigham and Women’s Hospital

2:15 – 2:40pm, Health IP

2:40 – 2:55pm, Break

2:55 – 3:20pm, Women’s Health

  • Aziza Ahmed, Professor of Law, Northeastern University School of Law

3:20 – 3:45pm, Reproductive Technology and Regulatory Oversight

  • I. Glenn Cohen, Professor of Law and Faculty Director, Petrie-Flom Center, Harvard Law School

3:45 – 4:10pm, Legal Responses to Zika

  • George Annas, William Fairfield Warren Distinguished Professor and Chair of the Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health; Professor in the Boston University School of Medicine, and School of Law

4:10 – 4:35pm, Flint, Water Safety, and Public Health Infrastructure

  • Wendy Parmet, Matthews Distinguished University Professor of Law, Director of the Center for Health Policy and Law, and Associate Dean for Interdisciplinary Education and Research Support; Professor of Public Policy and Urban Affairs, Northeastern University School of Public Policy and Urban Affairs

4:35 – 5:00pm, Concussion Litigation and Legislation in Sports

  • Christopher Deubert, Senior Law and Ethics Associate, Petrie-Flom Center Law and Ethics Initiative, Football Players Health Study at Harvard University

5:00pm, Adjourn

Learn More

How did our prognosticators do in predicting health law and policy developments they expected in 2016? Check out videos of all of the presentations at the 4th Annual Health Law Year in P/Review event, held in January 2016, and find out!

Register Now!

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, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

The Best-Laid Plans For Health Care

This new post by Petrie-Flom’s Faculty Director I. Glenn Cohen appears on the Health Affairs Blog as the first entry in a series that will stem from our Fifth Annual Health Law Year in P/Review event to be held at Harvard Law School on Monday, January 23, 2017.

“The best-laid plans of mice and men often go awry.” This phrase, adapted from the 1785 Robert Burns Poem “To a Mouse” and made as the source of the title of a Steinbeck novella, may become the mantra for health policy in 2017.

The Affordable Care Act (ACA) was the largest and most ambitious alteration to American health policy in a generation. By the middle of 2016, it appeared to be largely “settling into place,” and the quartet of Supreme Court encounters with the law have by now been largely resolved. The Constitutional commerce and taxation clause challenges of NFIB v. Sebelius have been decided, with the Court weakening Medicaid expansion and causing other problems, albeit not ones that threatened the vitality of the overarching statutory scheme due to preservation of the individual mandate.

The decision in King v. Burwell left funding for the insurance Exchanges intact. Controversy over the contraceptive coverage requirements stemming from the Act remains, with the Court punting on the extent to which its analysis from Burwell v. Hobby Lobby ought to apply to challenges raised by other types of objectors in Zubik v. Burwell, leaving the litigants with a strange “Can’t you guys just work this out on remand?” sort of resolution. […]

Read the full post here!

REGISTER NOW (1/23)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law. Continue reading

Tom Price Endangers Women’s Health

In today’s NYTimes, Jill Horwitz and I have an Op-Ed describing why Donald Trump’s selection of Tom Price for secretary of health and human services is a particular threat to women’s health. Read it here!

From the Op-Ed:

With the selection of Representative Tom Price as secretary of health and human services, President-elect Donald J. Trump has taken a giant step toward undermining the health of American women.

It is regrettable, but not surprising, that Mr. Trump has nominated a strident opponent of abortion. It is also no surprise that Mr. Price, an orthopedic surgeon from Georgia, earned a zero rating from Planned Parenthood, an organization he’d like to defund, despite its role in providing preventive health services. […]

Read the full article here!

LIVE ONLINE TODAY @ NOON: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

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Webinar: President-Elect Trump’s Health Policy Agenda: Priorities, Strategies, and Predictions

Monday, December 19, 2016, 12:00 – 1:00pm

WATCH LIVE ONLINE!: http://petrieflom.law.harvard.edu/events/details/president-elect-trumps-health-policy-agenda

Submit your questions to the panelists via Twitter @PetrieFlom.

Please join the Petrie-Flom Center for a live webinar to address what health care reform may look like under the new administration. Expert panelists will address the future of the Affordable Care Act under a “repeal and replace” strategy, alternative approaches to insurance coverage and access to care, the problem of high drug prices, innovation policy, support for scientific research, and other topics. The panel will discuss opportunities and obstacles relevant to President-elect Trump’s proposals, as well as hopes and concerns for health policy over the next four years. Webinar participants will have the opportunity to submit questions to the panelists for discussion.

Panelists

  • Joseph R. Antos, Wilson H. Taylor Scholar in Health Care and Retirement Policy, American Enterprise Institute
  • Lanhee J. Chen, David and Diane Steffy Research Fellow, Hoover Institution; Director of Domestic Policy Studies and Lecturer, Public Policy Program; affiliate, Freeman Spogli Institute for International Studies, Stanford University
  • Douglas Holtz-Eakin, President, American Action Forum
  • Moderator:Gregory Curfman, Editor-in-Chief, Harvard Health Publications

Continue reading

REGISTER NOW (1/23/17)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda Continue reading

Losing the Arms Race: Health Policy and Anti-Microbial Resistance

By Seán Finan

And scattered about it, some in their overturned war-machines, some in the now rigid handling-machines, and a dozen of them stark and silent and laid in a row, were the Martians–dead!–slain by the putrefactive and disease bacteria against which their systems were unprepared; slain as the red weed was being slain; slain, after all man’s devices had failed…

H.G. WellsThe War of the Worlds  

The WHO World Antibiotic Awareness Week ran from 15-22 November. It coincided with similar European and American initiatives. So, in the interests of raising awareness, I thought I would highlight a few figures.

Photo by Rocky Mountain Laboratories, NIAID, NIHAntimicrobial resistance currently causes an estimated 70,000 deaths annually. If current practices continue, the death toll is expected to hit to ten million per year by 2050. That works out at about one death every three seconds.

The threat isn’t limited to increased mortality. Anti-microbial resistance could cast medical practice back to turn-of-the-century standards. Turn of the 20th century, that is. Without antibiotics, the chance of infection turns chemotherapy and invasive surgeries into mortal gambles. During these procedures, the body’s immune system is subject to massive exposure and needs antibiotic support. Even ordinary nicks and scratches can lead to fatal infections without effective antibiotics.

So what is antimicrobial resistance? How does it come about? What can we do to combat it and prevent the “antibiotic apocalypse”?

Continue reading

Code Red

By Gregory M. Lipper

“Not Just Obamacare: Medicaid, Medicare Also On GOP’s Chopping Block,” write Jonathan Cohn and Jeffrey Young in The Huffington Post:

Donald Trump and Republican leaders in Congress have made clear they are serious about repealing Obamacare, and doing so quickly. But don’t assume their dismantling of government health insurance programs will stop there.

For about two decades now, Republicans have been talking about radically changing the government’s two largest health insurance programs, Medicaid and Medicare.

Check out the full, detailed article here.

Greg Lipper (@theglipper) is a partner at Clinton Brook & Peed and the former Senior Litigation Counsel at Americans United for Separation of Church and State.

MONDAY (10/24): Health Care after the Election

presidential_nominees_slideHealth Care after the Election
October 24, 2016 12:00 PM
Wasserstein Hall, Milstein West AB (2019)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

Description

As we approach the 2016 presidential election and change of administration, there are many questions about the future of health policy that the 45th President and Congress will have to address starting in 2017. This event brings together health care experts from both sides of the aisle to discuss what health care will – and should – look like under the next administration.

Possible topics for discussion include:

  • The Affordable Care Act
  • Drug pricing
  • Delivery system reform
  • Innovation and research funding/NIH
  • Mental health
  • Public health

Continue reading

The Evolving Crisis of the ACA Exchange Marketplace

By Zack Buck

Following news last week that Aetna was pulling out of health care insurance exchange markets in eleven states, Pinal County, Arizona became the epicenter in the rapidly evolving and growing crisis facing the Affordable Care Act’s insurance exchanges.  Sandwiched between Phoenix and Tucson, Pinal County is home to about 400,000 residents, but no insurance companies; in short, Pinal County has been left without any insurance companies signed up to sell insurance on the exchange to its residents for 2017—becoming the “county that Obamacare forgot.”

Pinal County had nearly 10,000 citizens sign up on the exchange in 2016, but Aetna’s departure bookends a rough period for Pinal County residents.  In addition to Aetna, the county has recently endured the departure of UnitedHealth Group, Humana, and a non-profit co-op from Arizona’s exchange.  As a result, Pinal County is reportedly looking to other insurers who may be interested in selling on the exchange to its residents; in a bit of hopeful news, Blue Cross Blue Shield of Arizona is said to be “re-evaluating where it will offer plans next year.”

But the crisis isn’t contained to Pinal County.  Two states—Tennessee and Alaska—have been trying to avoid a similar fate.

Continue reading

Still Seeking Contraceptive Compromise After Zubik v. Burwell

[Crossposted from RegBlog]

By Allison Hoffman

Zubik v. Burwell was this year’s Affordable Care Act (ACA) appearance on the Supreme Court stage. Consolidated with six other cases, Zubik challenged the ACA requirement that group health plans and health insurance issuers must provide free coverage of preventative services, including all contraceptive methods approved by the U.S. Food and Drug Administration (FDA).

Some religious groups believe that the use of some or all contraceptives is morally wrong. In response, the initial preventive services regulation exempted houses of worship, such as churches, from the requirement altogether. For religious nonprofit organizations, such as universities and hospitals, later regulations created an accommodation that enabled employees to receive coverage for contraceptives without the employer having to provide it.

Even though the U.S. Department of Health and Human Services (HHS) has tried to make it easy for nonprofit organizations to receive the accommodation, it still requires those organizations, unlike churches and other houses of worship, to ask for it affirmatively through a process of self-certification. Continue reading

New Resource: BPCIA Legislative History Documents

The Petrie-Flom Center is pleased to announce the availability of a new resource on its website: the legislative history of the Biologics Price Competition and Innovation Act (BPCIA).  The BPCIA, passed as part of the Affordable Care Act (ACA), created a pathway for the approval of biosimilar products and awarded innovator biologic companies twelve years of exclusivity for their products.  Modeled after the Hatch-Waxman Act of 1984, which established our system of generic small-molecule drug approvals while simultaneously creating a five-year period of exclusivity for new drugs, consideration of the BPCIA’s history is often lost in the discussion over the ACA’s history as a whole.  This resource selects only those documents relating to the BPCIA and may thus prove particularly useful for scholars of FDA law.

This new resource comes at an opportune time, as the courts and Congress have both turned their focus to the provisions of the BPCIA.  In 2015, the Federal Circuit issued a divided opinion interpreting the BPCIA’s instructions to biosimilar and innovator drug sponsors, and that opinion has now been appealed to the Supreme Court.  Just last month, the Justices called for the views of the Solicitor General on this question, a step which may significantly increase the likelihood of an eventual cert grant.  At the same time, several members of Congress have introduced a bill that would decrease the BPCIA’s grant of exclusivity from twelve years to seven years, bringing it more in line with the five-year period in the Hatch-Waxman Act or seven-year period in the Orphan Drug Act.  The twelve-year period of exclusivity may have been the most contentious aspect of the BPCIA as passed, with even the FTC arguing strongly against such a lengthy period at the time.

Members of the public may also be interested in an article written by Professor Erika Lietzan and colleagues providing an excellent analysis of the BPCIA’s legislative history.

Pay No Attention to Those Tens of Thousands of Women Affected by the Contraception Litigation

Photo: Hobby Lobby

Flickr/Creative Commons—m01229

By Gregory M. Lipper

In her latest column, Linda Greenhouse predicts that the Supreme Court’s order in Zubik v. Burwell will not produce the desired happy compromise between the government and the religious organizations who object to the government’s arranging for their students and staff to receive contraceptive coverage from third parties. Towards the end, Greenhouse also describes how the objectors have inaccurately insisted that these cases are about nuns and only nuns—ignoring the dozens of other plaintiffs whose students and staff number in the tens of thousands—and how legal commentators (some of whom should know better) have gone along:

[T]here is a widespread misunderstanding that the case is about nuns, specifically the Little Sisters of the Poor, a religious order whose mission is to run nursing homes for the elderly poor. Commentary following last week’s decision perpetuated this misunderstanding. “Surely the Obama administration could find a way to provide contraception to women without involving a group of Catholic nuns,” Ramesh Ponneru, a senior editor of National Review, wrote in a Bloomberg News post titled “The Culture War Obama Didn’t Have to Wage.” Richard W. Garnett, a law professor at the University of Notre Dame, wrote on Scotusblog that the Obama administration had “aggressively and unlawfully overreached” in its “strange insistence that a community of nuns who take vows of poverty and care for the elderly poor must serve as a vehicle for delivering free contraception to their employees.” In a Wall Street Journal column titled “Big Win for Little Sisters,” William McGurn wrote that “though it was more a TKO than a straight-up ruling, the Little Sisters prevailed at the Supreme Court Monday in their fight against the Obamacare contraceptive mandate.”

This single-minded focus on Little Sisters of the Poor—which itself employs hundreds of people of different religious faiths in multiple states—overlooked the tens of thousands of women who will lose contraceptive coverage if the objectors prevail:

By my count, the Little Sisters of the Poor (who, as I’ve noted before, advertise themselves as equal-opportunity employers in the nursing home enterprise) are only one of 30 petitioners in the seven Supreme Court cases. The other 29 include Catholic and Baptist colleges, Catholic high schools, individual bishops, two chapters of Catholic Charities, other charities, and several individuals.

If anything, there are more objectors and more affected women than even Greenhouse suggests.

Continue reading

Religion or Women?

In response to the religious objections levied against the contraceptives coverage mandate at issue in Hobby Lobby, Zubik, and gobs of other cases, many have argued that this was really a matter of subjugating women – not about religion per se.  Well, now we have a test case: Vermont’s governor just signed into law a requirement that public and private health insurance cover vasectomies without copays and deductibles. There won’t be the same arguments about abortifacients here, but many religious employers should object just the same, if they’re being consistent. Now let’s watch and see…

What to Expect When You’re Expecting at Least Another Year of Contraception Litigation

Photo: Zubik Rally

Tim Ritz/Americans United for Separation of Church and State

By Gregory M. Lipper

In a unanimous, unsigned order hailed as “an almost hilariously brazen punt,” the Supreme Court sent Zubik v. Burwell and the other contraception cases back to the lower courts for further consideration. The order states that, in light of the supplemental briefs submitted at the Court’s request, the parties should have “an opportunity to arrive at an approach going forward that accommodates petitioners’ religious exercise while at the same time ensuring that women covered by petitioners’ health plans ‘receive full and equal health coverage, including contraceptive coverage.’”

That, of course, describes the current accommodation, which the Court in 2014 touted as a compromise that protected women’s interests while relieving religious objectors’ of any burdens created by the previous requirement that they provide and pay for the coverage themselves. But the Court, likely split 4–4 on whether even that accommodation complies with the Religious Freedom Restoration Act, wants the parties to see if they can compromise further without subjecting women to second-class care.

These cases will almost certainly return to the Supreme Court, which may or may not have nine members by that time. But in the meantime, things are up in the air—especially for affected women:

1. The Court decided—nothing. Although objectors’ lawyers claimed victory, even the most nimble of advocates would struggle to identify an actual victory from an order that “expresses no view on the merits of the cases.” Lest any misunderstanding persist, the Court reiterated that it took no position on any of the underlying legal questions:

In particular, the court does not decide [1] whether petitioners’ religious exercise has been substantially burdened, [2] whether the Government has a compelling interest, or [3] whether the current regulations are the least restrictive means of serving that interest.

Those questions will be decided again by the Courts of Appeals, all but one of which has already ruled against the objectors. A victory this is not.

Continue reading

SCOTUS and More Surprises on Zubik

After the 2014 SCOTUS decision in Hobby Lobby, in which a closely-held for-profit employer won the argument that the federal Religious Freedom Restoration Act protected it against enforcement of the government’s contraceptives coverage mandate, all eyes have been on what SCOTUS would do in response to a challenge to the very same accommodation it toyed with as a less restrictive alternative in that case.  The Court agreed to hear a consolidated set of challenges to the accommodation brought by several religious non-profit employers who seek outright exemption from the mandate (under the case name Zubik et al.) – but then Justice Scalia passed away, leaving the Court with the unpalatable prospect of a 4-4 decision.

SCOTUS has pulled a few tricks out of its hat to avoid that possibility.  First, it surprised us by seeking supplemental briefs on a possible compromise solution, which would ostensibly allow women to access contraceptives (as the government desires) while not burdening the religious employers (as they desire).  The parties basically responded, as politely as would be expected, that some compromise was indeed possible – but not on terms the other could or would actually accept.  Nonetheless, today, SCOTUS surprised us again – seeing enough glimmer of a possible compromise to decline to decide the cases on the merits, instead returning them to the lower courts to work something out.

So what does that mean?  In my view, count it as a win for the government.  Eight out of nine circuit courts ruled in the government’s favor below, holding that the accommodation it had already offered did not substantially burden employers’ religious beliefs – which means that RFRA’s further protection, demanding a compelling government interest satisfied in the least restrictive way, does not even get triggered. These courts have no reason to change that determination now.  Even if there is a compromise that would be less burdensome on religious employers (which I don’t think there is), such a compromise is not required under RFRA unless there is a substantial burden.  And SCOTUS hasn’t said there is.

What we have here is, ironically, precisely the same result we’d have had if SCOTUS had issued a 4-4 decision.  The lower court opinions will almost certainly stand, and we’ll likely still have a bit of a circuit split. So now, we wait on a new president.  The Donald would presumably destroy the ACA/mandate entirely, whereas Hillary would hopefully be able to deliver a ninth justice that will recognize RFRA’s reasonable limits.  Religious freedom is critically important, but so too is accepting the government’s dramatic efforts to be accommodating, short of letting every religious believer be an island unto himself.

How Not to Debate Health Care Reform

Editor’s Note: This post was originally published on May 12 with portions of the essay missing. The corrected text is below.

By Ted Marmor

Presidential campaigns in the United States are not typically fought over competing manifestos, with policy details set out in reasonably clear language. Rather they are disputes among candidates about the state of the country and what values—or aspirational visions—they endorse.  And, for at least a century, most American debates about health care reform have been dominated by ideological slogans, misleading claims about financing, and mystifying labels. Republicans have exemplified the mystification this year, repeatedly mislabeling Obamacare as socialized medicine and falsely claiming it a “takeover of American medicine.”

In fairness, the Democratic primaries have generated their own version of mystification. The two candidates do agree on the goals of universal health insurance. But clarity ends there. The Clinton campaign has emphasized incremental reform possibilities and criticized Senator Sanders’ proposal of Medicare for All as unrealistic. Sanders, by contrast, has offered a compelling conception of a fairer and less expensive version of what Americans want, but no incremental steps to get to it.

Continue reading

Separating sheep from goats- a European view on the patent eligibility of biomedical diagnostic methods

New publication on the patentability of biomedical diagnostics out:

Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for a comparative discussion of the current US approach and its’ impact on biomedical innovation. We are concerned that unless the Supreme Court clarifies its two-part test and adopts a more holistic interpretation of the eligibility-test, global standards for medical diagnostic patents will diverge to the detriment of advanced therapies and ultimately patients worldwide. In case that the current US eligibility doctrine prevails without further Supreme Court clarification, we highlight the need for developing a more flexible, well-calibrated system for alternative and complementary forms of drug development incentives. In addition to a better-funded and well-administered prize system (an interesting option for some areas of diagnostics that we did not elaborate upon), our paper highlights the need for an improved and more flexible system for regulatory exclusivities in this sector.

Citation: Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods Timo Minssen; Robert M. Schwartz Journal of Law and the Biosciences 2016; doi: 10.1093/jlb/lsw019