Worth Reading This Week

By Nicolas Terry

Introducing Diana R.H. Winters

We are excited to introduce Diana R.H. Winters as an occasional contributor to Bill of Health.

WintersDiana has been an Associate Professor at Indiana University McKinney School of Law since 2012. She joined McKinney Law from Boston University Law School, where she was a Visiting Assistant Professor and the Health Law Scholar. Before that, Winters was an Assistant Solicitor General in the New York State Attorney General’s Office. Winters is also a founding board member of the Indianapolis (Indy) Food Council. She is currently researching the structure of food regulation, and the judicial review of health and safety regulation. She teaches Torts, Health Law, Environmental Law, and Food Law and Policy.

Representative Publications:

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What are GM Foods?

[Ed Note: Cross posted at HealthLawProfBlog.]

By Joanna Sax

I read a lot of press and listen to the politics surrounding genetically modified (GM) foods; but it appears that there is a lack of understanding that almost all of our food supply is integrated with GM crops. I imagine that many readers of this blog already know this, so this may simply be background for some of you.

The focus of the debate appears to be on GM foods that contain some sort of exogenous genetic modification that allows them to be pest or insect resistant, either through DNA or RNAi. That is, a specific DNA or RNAi sequence is inserted into the seed that is known to interfere with a biochemical reaction that allows, for example, the crop to be resistant to a specific type of pest.

But, the reality is that almost all of our crops are genetically modified, if not through the insertion of exogenous DNA or RNAi, then through various husbandry techniques. For example, seeds may be hit with UV radiation, which causes double stranded DNA breaks and subsequent mutations. These seeds are then selected for desired traits, such as pest resistance or other hardy characteristics. So, then through husbandry techniques, the seeds are grown into crops with mutations to the endogenous DNA. For these crops, we know that they demonstrate some sort of feature that is desirable to the farmer (or consumer), but we have little idea about what other mutations they may carry.

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Art Caplan: Everyday Ethics

Art CaplanBill of Health Contributor Art Caplan and ethicist Kelly McBride have launched a new twice-weekly podcast, Everyday Ethics, in which they explore the moral dimensions of our everyday lives. Recent topics have included conflicts of interest on Dr. Oz, recent “Right to Try” laws, and Jenny McCarthy’s anti-vaccination campaigns.

You can access the podcast online here, or subscribe to it on iTunes.

Introducing Greg Curfman

We’re pleased to formally introduce Dr. Greg Curfman as a contributor to Bill of Health. Dr. Curfman is already a familiar face here as a regular guest, and we’re thrilled to officially welcome him.

dr-gregory-curfmanDr. Curfman is currently the executive director of the New England Journal of Medicine, a position he has held for 14 years. In his tenure at NEJM, he has founded and currently directs the Perspective section, which focuses on issues at the interface of medicine and society. His work at NEJM has played a critical role in driving the national dialogue on health care.

A board-certified internal medicine physician and cardiologist, Dr. Curfman is also an assistant professor of medicine at Harvard Medical School. He graduated magna cum laude from Princeton University and received an M.D. cum laude from Harvard Medical School. Dr. Curfman has previously served as the director of the coronary care programs at the Brigham and Women’s Hospital and Dartmouth-Hitchcock Medical Center, and was also medical director at the Cardiovascular Health Center at Mass General.

Dr. Curfman regularly publishes on current topics in health law and the regulation of medical products. His publications include:  Continue reading

Analysis: Judge Myron Thompson’s Opinion on Alabama Law Employs a Fresh and Useful Template for Applying the Undue Burden Standard

[Ed. Note: Cross-posted from Reproductive Rights Prof Blog]

By Caitlin E. Borgmann

Today, U.S. District Judge Myron Thompson issued a decision – following a 10-day bench trial – declaring unconstitutional Alabama’s admitting privileges requirement for abortion providers.  The decision is remarkable in at least two respects.  First, Judge Thompson employs a brilliant interpretation of Planned Parenthood v. Casey that is different from any lower court opinion I have seen and yet that is well-grounded in the decision.  (He had already laid out this framework in an earlier ruling on summary judgment.)  It resolves a longstanding puzzle about the undue burden standard, namely whether and how a court should factor in the state’s burden of justification for an abortion restriction when it conducts an undue burden analysis.  Judge Thompson focuses in on a little-noticed aspect of Casey, namely its reliance on ballot-access case law.  The Casey joint opinion analogizes to the states’ “substantial flexibility in establishing the framework within which voters choose the candidates for whom they wish to vote,” in order to explain why “not every law which makes a right more difficult to exercise is, ipso facto, an infringement of that right.”  Yet, in describing the state’s power to regulate elections as “similar” to its power to regulate abortion, the Court suggests that its analysis in the ballot access cases is instructive in the abortion context.

Judge Thompson takes up this suggestion.  He points out that, in the specific cases that the Casey joint opinion cites, the Court looked at whether the state’s interest in the election regulation was “sufficiently weighty” to justify the restriction it imposed.  In Anderson v. Celebrezze, for example, the Court explained that, when analyzing constitutional challenges to specific provisions of a state’s election laws, the Court

must first consider the character and magnitude of the asserted injury to the rights . . . that the plaintiff seeks to vindicate. It then must identify and evaluate the precise interests put forward by the State as justifications for the burden imposed by its rule. In passing judgment, the Court must not only determine the legitimacy and strength of each of those interests, it also must consider the extent to which those interests make it necessary to burden the plaintiff’s rights. Only after weighing all these factors is the reviewing court in a position to decide whether the challenged provision is unconstitutional.

Judge Thompson applies this framework, first analyzing the burden that Alabama’s admitting privileges requirement would impose on abortion access in the state.  Finding that the burden would be substantial, he then closely examines the state’s purported justifications for the law and concludes that they are “exceedingly weak.”

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The FDA Takes Steps Toward Regulating Laboratory-Developed Tests

On Thursday, the FDA finally began to take an action that it had been publicly contemplating for over four years: the regulation of laboratory-developed tests (LDTs). In the FDA’s words, LDTs are diagnostic tests which are “designed, manufactured and used within a single laboratory.” There are thousands of LDTs, including very high-profile ones, such as Myriad Genetics’ test for assessing breast cancer risk. Although these diagnostic tests fall under the Federal Food, Drug, and Cosmetic Act’s (FDCA) definition of “medical device,” the FDA has for decades stated it was exercising its enforcement discretion in declining to regulate LDTs. (The FDA has exercised its regulatory powers over diagnostic tests that are designed and manufactured by one laboratory and sold to another for use.)  Although the official draft guidelines have not yet been released, the FDA’s report regarding their anticipated contents suggests that regulation of LDTs will follow a risk-based framework similar to the one in place now for other medical devices.

Much (though not all) of the relevant industry opposes the FDA’s actions here, and it’s easy to see why. Many of these LDTs would now be subject to premarket review, or at the very least additional reporting requirements, which make the development of these tests both riskier and more expensive.  Some firms argue that the FDA lacks jurisdiction to regulate LDTs, but they also argue that their LDTs are already sufficiently regulated by the Clinical Laboratory Improvement Amendments (CLIA), under the auspices of the Centers for Medicare and Medicaid Services. But here’s the problem: CLIA and the FDCA regulate different aspects of LDTs. And it can be detrimental to patient health to leave the FDCA aspects of LDTs unregulated.

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Immediate Job Opening: Clinical Ethicist at Boston Children’s Hospital

Clinical Ethicist

Boston Children’s Hospital

Boston, MA

The Office of Ethics at Boston Children’s Hospital has an immediate opening for a clinical ethicist. 

Applications are being accepted online, at www.childrenshospital.jobs.   To locate the position on the website, enter “32902BR” in the box labeled “AutoReqID.”

Boston Children’s Hospital is a 395-licensed-bed children’s hospital in the Longwood Medical and Academic Area of Boston, Massachusetts. At 300 Longwood Avenue, Children’s is adjacent to its teaching affiliate, Harvard Medical School.

Job description: Clinical Ethicist 32902BR

The Clinical Ethicist provides formal and informal ethics consultations.  Organizes and participates in clinical ethics rounds, and collaborates with clinical teams, patients and families, to address ethical issues in pediatric health care and research. Develops ethics resources and education and serves as a facilitator for change directed toward strengthening the Hospital staff’s sense of moral responsibility and moral community.

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The Revival of Phage Therapy to Fight Antimicrobial Resistance – Part I: What are the legal implications?

Last week I blogged about recent publications concerning the global battle against anti-microbial resistance (AMR). I did not mention a recent paper published in the June 2014 issue of Nature, which describes how European and U.S. researchers and authorities are increasingly considering clinical research in unconventional areas to fight AMR. The news-report “Phage therapy gets revitalized” by Sara Reardon concentrates on the use of viruses (bacteriophages) to battle bacteria. The idea is not new, but apart from some applications in the former Soviet Union, it never was established as a major research area elsewhere. In particular the paper examines the European Phagoburn project, which is the first large, multi-centre clinical trial of phage therapy for human infections, funded by the European Commission. It involves a phase I-II trial of using viruses for the treatment of bacterial infection following burns. The European Union (EU) is contributing €3.8 million (US$5.2 million) to the Phagoburn study demonstrating that it is taking the approach seriously. Meanwhile, the US National Institute of Allergy and Infectious Diseases announced in March 2014  that it regards phage therapy as one of seven key areas in its strategy to fight antibiotic resistance.

So far Western practice has concentrated on treating complex or unidentified infections with broad-spectrum antibiotics. These antibiotics would typically eliminate multiple types of bacteria, including those who have beneficial effects to the human organism. Despite resulting in direct negative consequences for patients, e.g. gastrointestinal disorders, these “atomic bomb” approaches can result in biological niches where resistant “bad bugs” can prosper. This is the reason why scientists are turning towards more targeted approaches. This is where phage therapy comes into play. Like “guided missiles”, phage-therapy has the ability to kill just species of bacteria or strain. Quoting the US virologist Ryland Young and the head of the scientific council at the Eliava Institute in Tblisi (Georgia), Mzia Kutateladze, the Nature report explains how nature offers an almost unlimited source of different phages and that so far no identical phages have ever been found. For this reason it is fairly simple to identify a particular phage for a bacterial target. If the bacterium should become resistant against that particular phage, researchers would modify the viral cocktails that are used for treatment by adding or substituting phages. At the Eliava Institute such updates occur – according to the report – approximately every 8 months and the scientists would not be fully aware of the precise combination of phages in the cocktail.

In light of these advantages the recent interest of US and EU stakeholders in phage therapy comes as no surprise. However, the scientific and legal challenges confronting these projects are complex. After all we are talking about viruses here, which triggers alarm bells with regard to public perception, safety concerns, and the regulation of relevant research. It also appears questionable if – or under what circumstances – regulatory authorities would be willing to grant market approval for such a rapidly changing product like in the case of e.g. influenza vaccines. Another significant problem for the development of new phage therapies, also addressed in the paper, lies in the reluctance of pharmaceutical companies to invest into the field. The potential obstacles for more private involvement in phage therapy are many and range from considerable risks of failure, reputational damage, and unforeseeable side-effects to insufficient certainty with regard to intellectual property protection and guarantees of a profit.

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Government seeks en banc rehearing in Halbig

Today the government moved for en banc rehearing in Halbig, as expected.  (HT: Rachana Dixit Pradhan @ insidehealthpolicy.com.)  I have not had the chance to review the petition but thought I would share it.  (For those looking to brush up on some of the blog debate on the case before reading, see here and here.  For more details on the en banc process see my earlier post here.)

The Government argues that rehearing en banc is warranted because the “disruption threatened” by Halbig makes the case one with exceptional importance.  One interesting bit did catch my eye, in light of that assertion.  It is footnote 7, which offers the Government’s view on the impact of the ruling in Halbig, and might be taken as sort of a cf.:

“The panel majority suggested that its ruling would apply nationwide, Op. 41-42, but it did not squarely hold as much or address the many reasons why relief should not extend beyond the named plaintiffs. The panel’s decision does not control in other circuits, just as the Fourth Circuit’s King decision does not control here.”

Here is the petition: Halbig En Banc Petition

My Slate Article on the Importance of Replicating Science

I have a long article in Slate (with Chris Chabris) on the importance of replicating science. We use a recent (and especially bitter) dispute over the failure to replicate a social psychology experiment as an occasion for discussing several things of much broader import, including:

  • The facts that replication, despite being a cornerstone of the scientific method, is rarely practiced (and even less frequently published) not only in psychology but across science, and that when such studies are conducted, they frequently fail to replicate the original findings (let this be a warning to those of you who, like me, cite empirical literature in your scholarship);
  • Why replications are so rarely conducted and published, relative to their importance (tl;dr: it’s the incentives, stupid);
  • Why it’s critical that this aspect of the academic research culture change (because academic science doesn’t only affect academic scientists; the rest of us have a stake in science, too, including those who fund it, those who help researchers produce it (i.e., human subjects), those who consume and build on it (other scholars and policy-makers), and all of us who are subject to myriad laws and policies informed by it); and
  • Some better and worse ways of facilitating that cultural change (among other things, we disagree with Daniel Kahneman’s most recent proposal for conducting replications).

The Fight Against Antimicrobial Resistance: Important recent publications

One of my previous blogs discussed the growing threat of antimicrobial resistance (AMR). I concluded that antimicrobial resistance is a growing and complex threat involving multifaceted legal, socio-economic and scientific aspects. This requires sustained and coordinated action on both global and local levels.

A recent medical review on drug resistant tuberculosis supports these findings and provides further fodder to the debate. In their study, which was published in April 2014 in The Lancet – Respiratory Medicine, the authors analyzed the epidemiology, pathogenesis, diagnosis, management, implications for health-care workers, and ethical and medico-legal aspects of extensively drug-resistant tuberculosis and other resistant strains. In particular, the authors discussed the increasing threat of functionally untreatable tuberculosis, and the problems that it creates for public health and clinical practice. The paper concludes that the growth of highly resistant strains of tuberculosis make the development of new drugs and rapid diagnostics for tuberculosis—and increased funding to strengthen global control efforts, research, and advocacy—even more pressing.

This was also recognized in the recent WHO’s Global Surveillance Report on AMR, which was published this April. It is the first WHO report that studied the problem of AMR on a global level. Noting that resistance is occurring across many different infectious agents, the report concentrates on antibiotic resistance in seven different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results demonstrate a wide-spread growth of resistance to antibiotics, especially “last resort” antibiotics. In particular the report reveals that this serious threat is no longer a mere forecast for the future. AMR is a contemporary problem in every region of the world and has the potential to affect anyone, of any age, in any country. Consequently the WHO report concludes that antibiotic resistance is now a major threat to public health that needs to be tackled on a global level.

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Weight Status: When Ignorance May Not Be Bliss

By Deborah Cho

A recent data brief summarizing a national survey spanning from 2005-2012 on the perception of weight status in U.S. children and adolescents highlights one major finding — many children and adolescents who are overweight or obese don’t know it.  Key findings were that about 81% of overweight (defined as having age- and sex-specific BMI greater than or equal to the 85th and less than the 95th percentile of the 2000 CDC growth chart) boys and 71% of overweight girls believe they are about the right weight.  Additionally, nearly 48% of obese (defined as having age- and sex-specific BMI greater than or equal to the 95th percentile of the 2000 CDC growth chart) boys and 36% of obese girls consider themselves to be about the right weight.  

As an article on the NPR blog noted, “Kids can be cruel, especially about weight. So you might think overweight or obese children know all too well that they’re heavy.”  But it seems that this is not the case, at least according to the survey.  Furthermore, not only do overweight or obese children generally seem to be unaware of their weight status, but the misperception rate appears to be higher in those children and adolescents whose families have a lower income-to-poverty ratio.  Non-Hispanic black and Mexican American children and adolescents were also found to have higher rates of misperception than Non-Hispanic white children and adolescents.

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Serious Risks from New Prescription Drugs

by Donald W. Light

Based on http://www.ethics.harvard.edu/lab/blog/436-new-prescription-drugs-a-major-health-risk

Few people know that new prescription drugs have a 1 in 5 chance of causing serious reactions after they have been approved. That is why expert physicians recommend not taking new drugs for at least five years unless patients have first tried better-established options and need to. Faster reviews advocated by the industry-funded public regulators increase the risk of serious harm to 1 in 3. Yet most drugs they approve are found to have few offsetting clinical advantages over existing ones.

Systematic reviews of hospital charts by expert teams have found that even properly prescribed drugs (aside from misprescribing, overdosing, or self-prescribing) cause about 1.9 million hospitalizations a year. Another 840,000 hospitalized patients given drugs have serious adverse reactions for a total of 2.74 million. Further, the expert teams attributed as many deaths to the drugs as people who die from stroke. A policy review done at the Edmond J. Safra Center for Ethics at Harvard University concluded that prescription drugs are tied with stroke as the 4th leading cause of death in the United States. The European Commission estimates that adverse reactions from prescription drugs cause 200,000 deaths; so together, about 328,000 patients in the US and Europe die from prescription drugs each year. The FDA does not acknowledge these facts and instead gathers a small fraction of the cases.

Perhaps this is “the price of progress”? For example, about 170 million Americans take prescription drugs, and many benefit from them. For some, drugs keep them alive. If we suppose they all benefit, then 2.7 million people have a severe reactions, it’s only about 1.5 percent – the price of progress?

However, independent reviews over the past 35 years have found that only 11-15 percent of newly approved drugs have significant clinical advantages over existing, better-known drugs. While these contribute to the large medicine chest of effective drugs developed over the decades, the 85-89 percent with little or no clinical advantage flood the market. Of the additional $70 billion spent on drugs since 2000 in the U.S. (and another $70 billion abroad), about four-fifths has been spent on purchasing these minor new variations rather than on the really innovative drugs.

In a recent decade, independent reviewers concluded that only 8 percent of 946 new products were clinically superior, down from 11-15 percent in previous decades. (See Figure) Only 2 were breakthroughs and another 13 represented a real therapeutic advance.

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MS Admitting Privilege Law Struck Down by 5th Circuit

Ed Note: Guest post by Jonathan F. Will

On July 29, 2014 a panel of the 5th Circuit struck down a Mississippi statute that would have effectively closed the only remaining abortion clinic in the state. Just four months ago a different panel of the 5th Circuit upheld a nearly identical statute enacted in Texas. Both statutes require physicians performing abortions to have admitting privileges in local hospitals.

The differing results are unremarkable because both the purpose and effects prongs of Casey’s undue burden analysis are necessarily fact driven. But there are some open questions worth highlighting from the decisions. The Mississippi law raises a matter of first impression. Namely, of what relevance is it, if any, that Mississippi women would have to cross state lines to obtain an abortion if the law was upheld? After all, even if the last abortion clinic closed, Mississippi women would have a shorter distance to travel to obtain such services than some Texas women now have because of the other 5th Circuit decision.

In striking down the Mississippi law, the 5th Circuit cited an Equal Protection case from the 1930s involving racial discrimination, and suggested (at least in part) that Mississippi cannot “lean on its sovereign neighbors to provide protection of its citizens’ federal constitutional rights.” The idea being that if a state cannot rely on a sister state to provide education for minorities, a state likewise should not be permitted to rely on a sister state to provide abortion services. Regardless of my feelings about the outcome of the case, I have to agree with the dissenting opinion of Judge Garza that this analogy doesn’t work very well.

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bioIP Junior Faculty Workshop: Call for Abstracts by Oct. 1

Call for Abstracts: 2015 bioIP Faculty Workshop

The American Society for Law, Medicine & Ethics (ASLME) is pleased to announce the first annual bioIP Faculty Workshop on May 7, 2015 at Boston University School of Law.

The Workshop will offer a unique opportunity for three junior scholars (in their first decade of teaching) to present their work in progress for in-depth critique and commentary by respected senior scholars in the field.

Topics for the workshop are at the intersection of biotechnology/life sciences/FDA and IP (hence, bioip), broadly defined. A Review Committee will select papers for the Workshop in a blind process. Papers should present an original thesis and contribute to scholarly literature. The Workshop will not review published work.

Scholars with less than ten years of teaching experience interested in having their papers reviewed should submit an abstract (up to 750 words) of the proposed paper (without identifying details) along with a c.v. to Ted Hutchinson, Executive Director of the ASMLE at  thutchinson at aslme.org by Oct 1, 2014. Selected abstracts will be announced later in Fall 2014 with the full draft papers due by April 1, 2015. The organizers will cover reasonable travel and lodging expenses. VAPs and Fellows are eligible for the Workshop.

The Workshop Committee consists of faculty from: The Boston University School of Law; Georgia State University College of Law; Indiana University Robert H. McKinney School of Law; and the Loyola University Chicago School of Law.

For questions, please email Kevin Outterson,   Posted in Biotechnology, Call for Abstracts, Events, FDA, Intellectual Property, Kevin Outterson | Leave a reply

Worth Reading This Week

By Nicolas Terry

Good news for many South African HIV patients—with a big glitch

On Wednesday, South African Health Minister Aaron Motsoaledi announced that, as of January 2015, HIV-positive patients in the country would start receiving free antiretroviral treatment once their CD4 count fell below 500, instead of current threshold of less than 350. Some patient groups would start receiving antiretrovirals immediately upon being diagnosed with HIV infection, regardless of their clinical stage.

Last month, Till Bärnighausen, Dan Wikler and I predicted in PLoS Medicine that sub-Saharan nations would move in the direction that South Africa is now moving, and pointed out a big complication. This policy change might make several gigantic trials of so-called treatment-as-prevention in sub-Saharan Africa impossible to complete successfully. As we explained, these trials remain important for assessing the potential of treatment-as-prevention to curb the spread of HIV in general populations (with many different relationship types and different levels of care delivery and support).

In treatment-as-prevention, antiretrovirals are offered to patients immediately upon their diagnosis with HIV. The hope is that very early treatment would be better for these patients and prevent them from infecting others. We also offered some ways out of this mess, but they involve untraditional approaches to research conduct and to policy. Our piece was featured in the June issue of UNAIDS’ HIV This Month.

The D.C. Circuit Got it Wrong. Congressional Intent on Exchange Subsidies Is Clear, If You Know Where to Look

By Robert I. Field

Why would Congress have limited Affordable Care Act subsidies to residents of only some states – those that establish their own insurance exchanges? The law authorizes credits for the purchase of insurance “through an Exchange established by the State under section 1311.” The D.C. Circuit found that this wording excludes federally established exchanges and that Congress might have intended this to induce states to establish their own exchanges rather than letting the federal government take over.

But the Court acknowledged that there is no evidence of such intent in the legislative history. And such a purpose would conflict with the ACA’s overall goal of extending health insurance access to all Americans.

With no legislative history as a guide, is there another plausible explanation of Congressional intent? Is the best answer to the D.C. Circuit’s opinion that the phrase was a drafting error, as the dissent seems to imply? Why else would it have found its way into the law?

Inartful though it may be, the wording can be seen to serve a different purpose that is consistent with the rest of the ACA. It can be understood not as a way to distinguish exchanges established by a state from those established by the federal government but to distinguish those established publicly from those created privately.

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The Problematic Jurisprudence of Halbig v. Burwell

Like the recent Supreme Court decision in Hobby Lobby, the D.C. Circuit’s ruling earlier this week in Halbig v. Burwell is being hailed by conservatives and bemoaned by liberals as a death knell for Obamacare.  Unlike the decision in Hobby Lobby, however the D.C. Circuit’s ruling is not the end of the matter, and many liberals are finding hope in the ruling of the 4th Circuit the same day, the probability of an en banc hearing in the D.C. Circuit, and the ultimate possibility of a favorable Supreme Court decision.  In an earlier post in HealthLawProf, I decided to take seriously the possibility of damage control from a limited reading of Hobby Lobby.  It is pretty much universally agreed—and I believe correctly—that it is not possible to do similar damage control by giving a limited reading to Halbig v. Burwell.  If the ruling stands, that tax subsidies are not available to people purchasing coverage through the exchanges in the states that are letting the federal government do the work, many important other provisions of the ACA will be untenable, including the penalties for large employers not offering insurance whose employees receive subsidies and likely the individual mandate itself.  But I think it is possible to undermine Halbig in a way not generally recognized by the liberal critics who argue (correctly) that the statutory provision at issue is ambiguous:  argue that the jurisprudence of the majority opinion in Halbig is internally inconsistent.  Here’s how. Continue reading