Category: Affordable Care Act

HLS Health Law Workshop with Leemore Dafny

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HLS Health Law Workshop: Leemore Dafny

November 10, 2014 5:00 PM
Griswold Hall, Room 110 (Harvard Law School)
1525 Massachusetts Ave., Cambridge, MA [Map here.]

Download the paper: “More Insurers Lower Premiums: Evidence from Initial Pricing in the Health Insurance Marketplaces” (co-authors, Jonathan Gruber and Christopher Ody)

Leemore Dafny is a Professor of Management and Strategy and the Herman Smith Research Professor in Hospital and Health Services at the Kellogg School of Management at Northwestern University. Her research examines competitive interactions among payers and providers of healthcare services, and the intersection of industry and public policy. Dafny’s work has been published in journals such as the American Economic Review and the New England Journal of Medicine, and featured in The New York Times, BusinessWeek, Bloomberg, and The Washington Post.

Current projects include studies of consolidation in the U.S. hospital industry and the kidney dialysis industry, organizational form of provider practices, copayment coupons for prescription drugs, and the implications of for-profit ownership of insurance companies.

PhRMA Sues HHS (Again) For Trying To Expand 340B Discounts To Orphan Drugs

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By Rachel Sachs

For all those who have been following the ongoing fight between pharmaceutical companies and HHS over the 340B Program’s coverage of orphan drugs (I know you’re out there), last week PhRMA filed a new complaint challenging HRSA’s interpretive rule on the subject under the APA. For all those who are not (but should be) paying attention to this battle, here’s what’s happening.

The 340B Program allows certain health care organizations (such as disproportionate share hospitals) to purchase drugs for their patients at significant discounts. The Affordable Care Act expanded the number and kind of organizations that can participate in the 340B Program, but it also added an exception stating that most of the covered organizations could not obtain 340B discounts for orphan drugs — or, as the statute puts it, for “a drug designated … for a rare disease or condition.” 42 U.S.C. § 256b(e).

The battle between PhRMA and HHS is over is whether this statutory exclusion applies to orphan drugs or orphan indications. There are many drugs which have received an orphan designation for certain indications but are also FDA-approved and prescribed more generally for non-orphan indications. In such a case, can a 340B facility purchase the drug at a discount if it is being prescribed for a non-orphan indication?  Read More

Limited Access to Contraceptives in Illinois

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By Alexandra Gross

What does “access” really mean for the purposes of PPACA’s contraceptive coverage mandate?

For two years, I’ve been enrolled in Loyola University of Chicago’s Student Health Insurance Plan, provided through a Blue Cross Blue Shield Illinois (BCBSIL) PPO plan. During this time, I have had to pay out-of-pocket for my contraceptive method every month. As a student studying health law, I was aware of the ACA’s contraceptive coverage mandate, § 2713 of the Public Health Services Act, which requires non-grandfathered health insurance plans to provide access to a full range of Food and Drug Administration approved contraceptive methods without cost sharing. The contraceptive coverage mandate reflects Congress’ determination that “access to preventive services without cost sharing is necessary to achieve access to basic health care,” particularly for women, as they have unique health care needs. The contraceptive coverage mandate also states that plans and insurers may impose “reasonable medical management techniques” to control costs and promote efficient delivery of care. For example, plans may cover a generic drug without cost sharing, but impose cost sharing for the equivalent brand name drug. Even with the imposition of medical management techniques, I still could not figure out why every single woman I talked to who was on my plan had a copayment of twenty dollars or more a month.

My colleagues and I assumed our issues with contraceptives were a result of attending a religiously affiliated institution. We were wrong. Loyola has properly sought a religious exemption from providing contraceptive coverage and communicated to the students and employees that BCBSIL should be accommodating us directly, without Loyola’s involvement. However, in practice, the accommodation is failing the students and employees at Loyola University of Chicago.  Read More

Expelling Immigrants from the Exchanges

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By Wendy Parmet

[Cross-posted from HealthLawProf Blog.]

The warning by the Centers for Medicare and Medicaid Services (CMS) last month that up to 115,000 people might lose their health insurance under the Affordable Care Act (ACA) unless they can send proof of their citizenship or immigration status was more than a bit ironic. After spending much of the year and millions of dollars trying to boost participation in the exchanges, CMS is now trying to reduce participation. In so doing, it will likely exclude many young, healthy adults, just the type of people that the exchanges need to succeed

The reason for the exclusion lies with the heated politics of immigration, and our ambivalent approach to providing immigrants with health care. Although the ACA’s critics have lambasted the law on many accounts, when the Act was first debated in Congress no charge – not even death panels! — was made more heatedly or drew more attention than the claim that the Act would cover illegal immigrants. It was that charge, after all, that Representative Joe Wilson referred to when he shouted “You lie!” during the President’s speech to a joint session of Congress.

Obama, however, didn’t lie when he promised that the Act would not cover illegal immigrants. The ACA bars from the exchanges immigrants who are “not lawfully present,” a category that includes the so-called Dreamers, the young immigrants who by virtue of an executive order have a right to live and work in the country. It also requires exchange applicants to provide their Social Security number and, in the case of non-citizens, information about their immigration status, which must be verified by the Department of Homeland Security. These are the requirements that CMS is now enforcing.  Read More

To Watch: Rural Enrollment on Exchanges

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As we gear up for a second year of exchange marketplace enrollment, one issue to keep an eye on is the success we have at getting people who live in rural areas onto the healthcare rolls.  As pointed out in today’s Kaiser Health News write-up (here), there is potential for the ACA to increase rural health disparities, even while it gets more people insured, because many of the efforts to encourage enrollment–think navigators, enrollment centers, advertising, and outreach–just work better in urban areas.  For some reading on this issue, see the Kaiser Family Foundation’s posting here, the HHS’s Health Resources and Services Administration’s report here, and the Rural Health Foundation’s roundup here.

Contraceptive Mandates and Conscience – All Objections Are Not Equal

The Petrie-Flom Center Staff Leave a comment

By Jonathan F. Will

In the wake of the Hobby Lobby decision, the US Department of Health and Human Services announced on Friday proposed rules regarding exemptions for those objecting to the contraceptive mandate.  Whenever I read about conscientious objections to health care services made by providers, patients, or indeed, employers, I am reminded that all objections are not equal.

As Mark Wicclair, and others, have written, studies show that medical professionals may object to services based on clinically false information.  For instance, certain pharmacists reported that they objected to emergency contraception on the mistaken belief that Plan B was the same thing as RU-486 (mifepristone, or the “abortion pill”).  Similarly, a prominent general practitioner admitted to making decisions regarding the prescription of oral contraception without fully understanding the mechanisms of operation that prevent pregnancy.  If medical professionals make decisions based on ignorance, one can suspect that lay employers and patients do as well.

This suggests that individuals often lack the information necessary to truly assess their stance on morally controversial services.  While the law does (and should) play a role in protecting conscience, it seems unsatisfying when such protection is granted to those holding underdeveloped views, and at the expense of (and detriment to) those seeking legal medical services.

The ACA and the Practice of Health Law

The Petrie-Flom Center Staff 1 Comment

By Louise Trubek, Barbara Zabawa, Paula Galowitz

Health law practice is undergoing radical restructuring in the wake of major changes in the health care system and the reorganization of the legal profession. The health care system is being transformed as the Affordable Care Act (ACA) and other factors promote the integration of clinics and hospitals, put greater emphasis on patient-centeredness, create incentives for value-based care, mandate public reporting on costs and outcomes, and provide subsidized coverage.  These changes in the health care system come at a time when the legal profession is also undergoing significant transformations.  In the corporate law sector, we see a major shift in the role of corporate general counsel and corresponding changes in the practice of outside corporate firms: General Counsel positions (GCs) are becoming more powerful and corporate firms are shifting from overall representation of companies to specialist niches. At the same time there is increased concern about access to justice for under-represented individuals while new programs to address unmet legal needs are emerging. Health care lawyers are caught up in this dual transformation as the nature and the setting for their practices change and they are called on to play new roles and develop new skills.

Our study of Transformations In Health Law Practice concentrates on two types of practice: the corporate law sector that serves business and the “access to justice” sector that assists individuals. Read More

The Political Economy of Medicaid Expansion

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By Christopher Robertson

Many health law profs have wondered about how state officials can turn down bucketloads of federal money, without suffering the ire of their local constituents.  In states like Arizona, that frustration was spoken most vocally by the local healthcare industry and their employees, who have the most to gain from the expansion of coverage, even if the Medicaid beneficiaries are unlikely to themselves have political clout.

Well, over at the New Yorker, Sam Wang has now compiled the polling data for the gubernatorial races to ask whether “In Swing States, Is Obamacare an Asset?”  This graphic tells the whole story, focusing on states where Republican incumbents who made Medicaid-expansion decisions are now up for re-election:

Chart09-09-updated[1]

Although voters respond to a mix of positions and personalities, and these are only nine states, it is striking that the governors who declined federal money to cover their most vulnerable are also the most vulnerable at the polls.

Another Hole in the Halbig Verdict

The Petrie-Flom Center Staff Leave a comment

Much attention has been paid recently to the contradicting decisions issued on the Halbig and King cases, which challenged the Obamacare subsidies offered to individuals purchasing insurance on federal exchanges. In a piece for Politico Magazine, Abbe R. Gluck finds a weakness in the Halbig plaintiffs’ arguments, in their own words. As Gluck writes:

What’s less known, however, is that in the 2012 constitutional case, these same challengers filed briefs describing Obamacare to the court in precisely the way they now say the statute cannot possibly be read. Namely, they assumed that the subsidies were available on the federal exchanges and went so far as to argue that the entire statute could not function as written without the subsidies. That’s a far cry from their argument now that the statute makes crystal clear that Congress intended to deny subsidies on the federal exchanges.

I am not a fan of the “gotcha” flavor that some aspects of this case have taken on, but the challengers’ 2012 statements are relevant as a legal matter because what the government has to prove to win—as a matter of black-letter law under the Chevron doctrine—is that the statute is ambiguous. (Chevron says that federal courts defer to the relevant agency’s reading of the statute when a federal statute is unclear—here, that agency is the IRS.)

The challengers have spent more than a year arguing that no reasonable reader of text could construe the statute in any way other than denying federal subsidies to insurance purchasers on exchanges operated by the federal government. But what about their statements from 2012—statements then echoed by Justices Scalia, Kennedy, Thomas and Alito in their joint dissent to the Supreme Court’s ruling in the constituitional challenge, NFIB v. Sebelius?

You can read more, including the relevant passages from the NFIB v. Sebelius briefs, here.

Government seeks en banc rehearing in Halbig

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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