Don’t Buy the Cooperative-Federalism-Makes-Halbig-Logical-Argument

The Petrie-Flom Center Staff Leave a comment

By Abbe Gluck

Cross-posted at Balkinization and Election Law Blog

I had hope to take a day off blogging about Halbig and King (the ObamaCare Subsidies cases), but I cannot allow another new, and inaccurate, narrative about ObamaCare to take hold. Over at Volokh, Ilya Somin argues that the holding in Halbig is not absurd because Congress uses statutory schemes all the time that try to incentivize states to administer federal law (and penalize them if they don’t).  It is true we see schemes like that all the time–Medicaid is a prime example–but the insurance exchange design at issue in these cases is NOT one of them.  This federalism argument was made before the D.C. Circuit and even Judge Griffith didn’t buy it in his ruling for the challengers.  I tried to dispel this myth back in March, when I wrote the following on Balkanization. As I said there, this isn’t Medicaid—it’s the Clean Air Act.

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Pharmaceutical Pricing– The Story That Just Keeps Going

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By Bob Bohrer

Cross-post from Pharmaceutical Policy

After last week’s foray into patents and pharmaceutical policy, which is perhaps the most technical and specialized area of pharmaceutical policy, I will return to the never-ending story of pharmaceutical prices and the controversy over Sovaldi, Gilead’s break-through Hepatitis C drug. Sovaldi has a “sticker price” of $84,000 for a 12-week course of treatment, at the end of which 90% or more of patients would be expected to be cured. Since Sovaldi is a pill that is given once a day, the 12-weeks of treatment means that there are 84 daily doses. The math is easy, even if the price, unlike the pill, is hard to swallow–$1,000 per pill. The drug has been a huge financial success for Gilead, which reported $2.274 billion in sales in just the first quarter of 2014.   However, the backlash has been equally huge. In a rare display of bipartisanship in Washington, Senator Ron Wyden (D.-Ore), the Chair of the Senate Finance Committee and Senator Chuck Grassley (R.-Iowa), the Ranking Member of the Finance Committee, sent a demand for information concerning the development costs of Sovaldi and Gilead’s pricing decision. However, even more than the investigation by two senior senators, the impetus for today’s post came from the blog RxObserver, which featured a post entitled Sovaldi: A Poster Child for Predatory Pricing [sic]. Before discussing the epithet “predatory pricing,” the perspective of RxObserver requires a bit of explanation. RxObserver is a site that primarily provides the views of pharmaceutical benefit managers (PBMs), or as the blog itself states its purpose: “the Clearinghouse of the Future for Pharmacy Benefits.” It is, in general, a very high-quality blog, with an editorial staff composed primarily of well-recognized academic and government experts in health care policy. I regularly read it and find it useful, although I was taken aback by that “predatory” epithet. Read More

Obama Administration to Revise Contraceptives Coverage Accommodation

Holly Fernandez Lynch Leave a comment

In response to the SCOTUS decision granting Wheaton College a preliminary injunction against having to comply with the terms of the HHS accommodation available to non-profit religious organizations who object to covering contraceptives for their employees (i.e., submitting a form to their insurance providers), the Obama Administration has announced that it will revise the terms of that accommodation. Instead of requiring objecting employers to provide the form and notice to insurers or third party administrators of self-insured health plans so that they can jump in to provide free coverage directly to employees, HHS will issue new regulations in short order, the details of which remain to be worked out, but will likely allow nonprofit institutions to write a letter stating their objections, rather than filling out the form (see the WSJ story here). This will leave the government to make sure employees are not left without contraceptives coverage.

I may be oversimplifying things, but I think this extended accommodation really isn’t such a big deal.  It seems to just add the government in as a middleman between the objecting employer and the insurer or third party administrator that was responsible for providing coverage under the original accommodation.  In other words, before, nonprofit religious employers with an objection had to fill out the form and give it directly to their insurers; after the modification, those employers could just let the government know, and presumably the government will notify their insurers.  A bit more bureaucracy, but shouldn’t be too big of a problem – probably just a drop in the bucket of the massive ACA bureaucracy, and potentially unnoticeable by the women seeking free contraceptives.  That is unless the employers claim that even this approach leaves them complicit in violation of their religious beliefs.

Since SCOTUS’s substantial burden test as applied in Hobby Lobby focused on the hefty fines for noncompliance, rather than the extent to which the employers’ religious beliefs were directly v. indirectly burdened, the complicity point is an important one to keep an eye on.  Will religious employers be satisfied with simply adding another link to the causal chain?  Perhaps (and I hope).  Technically, all they would be asked to do is announce to the world that they have a religious objection.  What the government does with that information is beyond their control.  If this works out, the revised accommodation could also be extended to the closely held for-profit corporations with religious objections to contraceptives coverage that SCOTUS determined could not be forced to comply with the mandate, such that their employees too could retain access.

So let’s see what HHS can come up with.  Haters gonna hate, as they say, so I’m sure there will be more litigation on this, but hopefully we’re nearing a solution – and I think a good compromise.  The bigger issue will be dealing with all those other services that must be included as essential benefits or preventive services to which religious employers may object, and to which insurers are likely to object to providing free coverage.  But let’s see if the ACA lives to die another day after Halbig and King.

When Should you Be Able to Subpoena Clinical Trial Data? “Clinical Trials and the Right to Remain Silent” in JAMA Internal Medicine

I. Glenn Cohen Leave a comment

Should litigants in products liability or other litigation be able to subpoena data from clinical trials to help prove their case? Does it matter whether the clinical trial is ongoing, finished recruiting but still analyzing data, or published? Michelle Mello and I have an invited commentary on this issue in JAMA Internal Medicine “Clinical Trials and the Right to Remain Silent” with our analysis and recommendations. We are discussing a real case from Yale where a subpoena was sought for data from a placebo-controlled trial of pioglitazone conducted there, where the person seeking the data had sued the manufacturer and believed she had been injured by pioglitazone but was not a clinical trial participant. In the same issue of JAMA IM, Yale gives its own account about how it handled the case here.  Dr. Kernan (the investigator) and I also have a nice interview podcast on the issue. 

The ObamaCare Subsidies Rulings–and the D.C. Circuit’s Disappointing Misreading of the ACA

The Petrie-Flom Center Staff Leave a comment

By Abbe R. Gluck

As most readers know by now, two federal appeals courts on Tuesday reached the opposite conclusions about the validity of the critical financial subsidies on the ACA’s federal health insurance exchanges. The Fourth Circuit in Virginia upheld the subsidies—indicating the government had the better argument, but regardless applying the longstanding rule that when a statute is not clear, courts defer to the agency administering the statute (in this case, the IRS). The D.C. Circuit, however, ruled the other way, reading one provision of this massive and complex federal law out of context. That opinion not only misinterprets the statute—with enormous practical consequences—but also does a deep disservice to conservative jurists and lawyers who have spent the last 30 years arguing that text-based interpretation is sophisticated, not literalistic, and serves democracy.

The stakes are enormous: If the D.C. Circuit’s opinion ultimately carries the day, more than $36 billion dollars in financial relief will be denied to the approximately 7 million people expected to be insured with the help of this financial assistance. It also places Republicans in a real dilemma, especially as the election cycle heats up: The result, if the ruling stands, would be massive red-state/blue-state disparity, as millions of middle-class Americans are deprived in red states of access to medical care, because it is mostly the red states whose subsidies are now at issue.

As I wrote yesterday on Balkinzation, the opinion is terribly disappointing from a statutory interpretation perspective. It relies in part on irrelevant legislative history (from the HELP committee, whose bill wasn’t even the basis for these provisions–the Finance committee’s was) and gets it wrong anyway (as I argued here); it bends over backwards to come up with reasons why Congress might have intended this result (which we all know it certainly did not); and it attaches far too much significance to a line in the statute that expressly deems exchanges in the territories to be state exchanges and does not replicate the special deeming language for the federal exchanges. The territories language is boilerplate language used by Congress when talking about territories in statutes even beyond the ACA, and should have been attached no significance here.

For a more detailed legal and political analysis, check out my op-ed on the cases.

How En Banc Review Would Work in Halbig

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This morning the D.C. Circuit ruled that the ACA “unambiguously restricts the section 36B subsidy to insurance purchased on Exchanges “established by the State.”  (See opinion here.)  In other words, the court ruled that the subsidies that make insurance on federally-operated exchanges affordable are illegal.

In the news and blog coverage this has already received, the possibility of this decision being reversed “en banc” has been mentioned.  (See here, here, and here for news, here and here for blogs.  For other blog reading on the opinion itself, see here and here.)  Having written a bit elsewhere about the logistics of the DC Circuit (see here), I thought I would chime in with specifics about exactly how the decision whether to rehear the case en banc, and en banc rehearing, would work.

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Halbig is out and the gov’t lost (but long live the King)

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By Kevin Outterson

My post at TIE: 4.683 million people get tax bills, lose coverage https://theincidentaleconomist.com/wordpress/4-683-million-unanswered-questions-in-halbig/

Also Nick Bagley at TIE: https://theincidentaleconomist.com/wordpress/a-stinging-defeat-for-the-government/

UPDATE: Gov’t wins in the 4th Cir companion case: https://theincidentaleconomist.com/wordpress/the-government-may-have-lost-in-d-c-but-it-just-won-in-the-fourth-circuit/

Health Care Decisions in the New Era of Health Care Reform

The Petrie-Flom Center Staff Leave a comment

The North Carolina Law Review has just released its symposium issue on Health Care Decisions in the New Era of Health Care Reform, featuring several Bill of Health contributors and friends of the Petrie-Flom Center.  Take a look at the description and contents below. [HT: Richard Saver, who served as faculty advisor for this issue, alongside Joan Krause.]

Optimal decision making in health care often proves challenging. Health care providers often confront multiple treatments for each condition with limited evidence as to which interventions work best; moreover, treatment decisions can implicate questions of ethics and personal values that may not be answerable by clinical expertise alone. Fragmented delivery systems lead to insufficient coordination among providers in managing patients’ overall care. Patients face significant informational disadvantage not only in dealing with clinical information, but also in making choices regarding health care insurance coverage. Payers must make reimbursement and coverage decisions with incomplete information about the value and cost effectiveness of many treatments. Governmental officials must make complex regulatory decisions in managing a health care system with seemingly endless demand, escalating costs, and limited resources.

According to some optimistic accounts, the new era of health care reform will radically improve health care decisions. The Patient Protection and Affordable Care Act includes many reform initiatives aimed at improving health care decision making. For example, the law encourages the formation of integrated delivery systems that share information and coordinate care, fosters the development of shared decision-making between providers and patients, develops a more comprehensive evidence base through comparative effectiveness research, and creates insurance exchanges where patients as consumers can choose between plans offering standardized benefits and compared in standardized formats. But there are also reasons for concern that, in the new era of health care reform, decision making will become all the more complex and daunting. This symposium will consider both the promise and limitations of recent reform efforts, highlighting the important issues that are likely to emerge as the health care system tries to improve decision making.

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When you Can Shed Blood for your Country but not Donate it

I. Glenn Cohen 2 Comments
Portsmouth, Va. (Jan. 5, 2005) - A hospital corpsman assigned to USS Bataan (LHD 5), donates a pint of blood during the blood drive held by the Blood Donor Team. The Blood Donor Team stationed at Portsmouth Naval Hospital visits multiple commands throughout the area in efforts to boost the blood supply for the U.S. Armed Forces around the world. U.S. Navy photo by Photographer’s Mate 3rd Class Jeremy L. Grisham (Image from Wikimedia Commons).
A hospital corpsman donates a pint of blood. U.S. Navy photo by Photographer’s Mate 3rd Class Jeremy L. Grisham (Image from Wikimedia Commons).

I have a new article in JAMA this week, “Reconsideration of the Lifetime Ban on Blood Donation by Men Who Have Sex With Men,” co-authored with my former student Jeremy Feigenbaum and my frequent co-author Dr. Eli Adashi (former Dean of Medicine at Brown). In the article we show that FDA’s current policy is morally, ethically, and legally problematic. We are out of step with our peer countries (including the UK, Canada, South Africa) who do delay when men who have sex with men can give blood but not for a lifetime, the way the U.S. does. It is remarkable that if you have sex with a female prostitute or a woman who is HIV+ you face only a 12-month deferral in the U.S. but if you have had sex with a man, just once, ever, no matter his HIV status you face a lifetime delay.

We are in a world where the Defense of Marriage Act was struck down as unconstitutional, where Don’t Ask Don’t Tell has been struck down so that gay men and lesbians can proudly serve their country and shed blood (their own, others) on the battlefield. It is time to change a 30-yr old policy prohibiting them giving blood. What’s more, given the the Windsor decision and the recent Ninth Circuit application of heightened scrutiny to the exclusion of gay jurors for jury duty, we think there are serious constitutional questions about FDA’s policy as well.

My preferred approach, and the one I think FDA should move towards, is the Italian “test and assess” which has no blanket classification of MSM but instead does individualized risk assessment. As we describe in our paper thus far has not increased the risk of HIV+ blood making its way into the blood supply.

The Williams Institute in 2010 estimated that 6% of men had at least once had sex with another man, meaning there are potentially 7.2 million men who could become blood donors but are excluded by FDA’s rule. We owe it not only to these men, but also to all those who could benefit from their blood donations to revisit this rule.

Just “Fix-It”

The Petrie-Flom Center Staff Leave a comment

Guest post by Gretchen Schwarze (Vascular Surgeon)

Cross-posted from GeriPal

She seemed awfully angry and at the very least dubious that I couldn’t do more for her father. After 7 hours of surgery trying to salvage her father’s leg, I tried patiently to explain that this new (third) bypass we had just successfully completed was unlikely to provide her dad with a long-term solution. Ultimately, he would lose the leg, if we were lucky he’d have it for another year or two. Accounting for the “unlucky” side of the coin was even more depressing; immediate wound or graft infection, a postoperative heart attack from the liter of blood I had just lost or early graft failure which few surgeons would attempt to reverse given the tenuous nature of the graft to begin with. I didn’t have the heart to mention these things too, she was already upset.

It’s conversations like these that make me feel like there is something intrinsically wrong with the way we conceptualize modern medicine, and by “we” I mean both doctors and patients. I worry that a much deeper issue – a larger social construct – plays a role in decision-making and influences treatment choices because it obscures the limits and boundaries of what health care can provide.

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