Tag: Affordable Care Act

(Final) Reply to Author of Cato Brief in Little Sisters Contraception Case

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Flickr Creative Commons/Charlie Marshall

By Gregory M. Lipper

This is the third and (I promise) final installment in my skirmish with Josh Blackman over a brief that he and Cato Institute filed in support of Little Sisters of the Poor’s quixotic challenge to regulations requiring them to fill out a form to obtain an exemption from providing contraceptive coverage to its employees. If you haven’t read the previous posts, you can do so here (my first post), here (Josh’s response to me), here (my first reply to Josh), and here (Josh’s second response to me). The basic gist is that, contrary to Cato’s brief, (1) HHS had the authority to implement the nonprofit accommodation, and (2) if HHS didn’t have the authority to issue the accommodation, then Hobby Lobby no longer controls whether the original contraceptive coverage requirement satisfies RFRA, because the Court in Hobby Lobby pointed to the HHS accommodation as the basis for concluding that a less-restrictive alternative exists.

Now, on to Josh’s most recent response.

First, Josh suggests that he’s not actually assuming away the basis of Hobby Lobby, because the HHS nonprofit accommodation could still in theory be enacted by Congress; even if HHS lacked the authority to issue the nonprofit accommodation, he says, it would still constitute a less-restrictive means and thus lead to the same result in Hobby Lobby (such that the Supreme Court can dodge the question in Little Sisters).

But that’s not right either. The premise of Hobby Lobby was that the less-restrictive alternative was existing and on the books; the accommodation was one that “HHS has already devised and implemented.” The Court added: “[W]e need not rely on the option of a new, government-funded program in order to conclude that the HHS regulations fail the least-restrictive-means test. HHS itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs.” Justice Kennedy, the decisive vote, added that “the mechanism for [accommodating the plaintiffs] is already in place.” (All emphases added by me.)

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A Reply to the Author of Cato’s Brief in the Little Sisters Contraception Case

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By Gregory M. Lipper

Josh Blackman has replied to my post criticizing the Cato Institute’s amicus brief (which Josh coauthored) in support of the cert petition in the Little Sisters contraception case. My original post made two arguments: (1) if you take away the nonprofit accommodation, Hobby Lobby no longer supplies a rule of decision, because the presence of the nonprofit accommodation was what led the Court to conclude that RFRA barred the coverage requirement, and (2) if you prevent regulatory agencies from offering reasonable, tailored accommodations to their regulations, the result is bad for religious liberty.

Two brief comment on Josh’s reply.

First, on the question of agency authority to issue religious accommodations, Josh incorrectly suggests that I miss a subtelty in his argument. Josh/Cato say that the Department of Health and Human Services (HHS) has authority to issue religious accommodations, but that it may not decide “which organizations were worthy of the exemption, and which would be burdened by the accommodation.” I address this argument in my original post: the Cato brief assumes that religious accommodations are all-or-nothing, but that is not how the Religious Freedom Restoration Act (RFRA) works. RFRA details when accommodations are available and when they are not (and the Establishment Clause limits accommodations that unduly harm third parties). So an agency (HHS, or otherwise) cannot, as a practical matter, offer accommodations without determining who is eligible for that accommodation and who is not. As I said in my original post, Cato “would force agencies to choose between a bludgeon and no tools at all, even when the agency would need a scalpel to craft religious accommodations consistent with RFRA.”

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Some Thoughts from a Health Lawyer on King v. Burwell

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By Joan H. Krause

[Cross-posted from Hamilton and Griffin on Rights]

The long-awaited and much-debated opinion in King v. Burwell is here. In an opinion written by Chief Justice Roberts – who almost single-handedly saved the ACA with his 2012 opinion in N.F.I.B. v. Sebelius – and newly joined by N.F.I.B. dissenter Justice Kennedy as well as the more liberal Justices, the Court agreed with the Fourth Circuit that the ACA’s tax credits (or “subsidies”) are available to individuals who purchase insurance through both State and Federal health insurance Exchanges. The Petitioners, four Virginia residents who did not wish to purchase health insurance, had argued that Virginia’s Federally-run Exchange did not constitute “an Exchange established by the State” under the ACA tax credit provision; because unsubsidized coverage would cost more than 8% of the Petitioners’ incomes, they would be exempt from the Act’s individual mandate and would not be required to purchase health insurance. While acknowledging that the Petitioners’ arguments regarding the “plain meaning” of the phrase were strong, the majority nonetheless sided with the Government, holding that the context and structure of the overall statute led to the conclusion that the statute permitted tax credits for insurance purchased on “any Exchange created under the Act,” whether State or Federal (slip op. at 21). Justice Scalia penned a scathing yet witty dissent (“We should start calling this law SCOTUScare,” slip op., Scalia, J. dissenting, at 21), arguing that the plain meaning of the language made clear that tax credits were available only on State exchanges, and that any flaws in the Act’s design should be left to Congress to fix.

Despite the attention it received, King was something of a stealth ACA case. Lacking the Constitutional controversies of N.F.I.B., it was in many ways a run-of-the mill statutory interpretation case focusing on four words in a massive document containing, in the words of the Chief Justice, “more than a few examples of inartful drafting” (slip op. at 14).   And yet the potential effects of the decision were perhaps even more far-reaching, in large part because of the timing. N.F.I.B.’s Commerce Clause analysis may have more precedential value in the long-run, but far fewer of the Act’s provisions had gone into effect in June of 2012. With approximately 7 million individuals now receiving insurance through the Federal Exchange, and the majority of them (an estimated 87%) receiving subsidies, the decision in King could have led to the devastating loss of insurance for millions of Americans.

While commentators will no doubt parse every sentence of the opinion (including the Court’s refusal to defer to the IRS’s interpretation of the statute under Chevron), as a health lawyer I found two aspects of the opinion notable. First, the Chief Justice drafted a very nuanced (and mercifully succinct) description of the health insurance market flaws the ACA was designed to address. The Chief Justice understood the ACA’s “three key reforms” – guaranteed issue and community rating of insurance policies, the individual mandate, and tax credits – as well as the ways in which the three were “closely intertwined” (slip op. at 3-4). The first few pages cite multiple horror stories from states where some, but not all, of these reforms were enacted; for data, the opinion cites liberally to the Brief for Bipartisan Economic Scholars as Amici.   In its depth (not to mention brevity), the analysis is completely different from the tortured description of health insurance found just a few years ago in N.F.I.B., evincing a far more sophisticated understanding of both the legal issues and the legislation itself.

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Last Year Was A Wild One For Health Law — What’s On The Docket For 2015?

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By Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen

This new blog post by Greg Curfman, Holly Fernandez Lynch and I. Glenn Cohen appears on the Health Affairs Blog:

Everywhere we look, we see the tremendous impact of new legal developments—whether regulatory or statutory, federal or state—on health and health care. These topics range from insurance to intellectual property to religion to professionalism to civil rights. They remain among the most important questions facing Americans today.

This post is the first in a series that will stem from the Third Annual Health Law Year in P/Review event to be held at Harvard Law School on Friday, January 30, 2015. The conference, which is free and open to the public, brings together leading experts to review major developments in health law over the previous year, and preview what is to come.

Read the full post here, and register for the Third Annual Health Law Year in P/Review for free here.

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

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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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Waiting for Hobby Lobby–A brief refresher of the issues

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Cross post from healthlawprof blog

Jennifer S. Bard

Since the likelihood is that many readers of this blog will be asked to comment when the Supreme Court, some time this week, announces its decision in Hobby Lobby and Conestoga Wood Specialty cases here’s a brief refresher and some links.  The cases are challenges to the Affordable Care Act’s requirement that employers who choose to offer health insurance to their employees must provide policies that include ten essential benefits-including contraception.  The U.S. Supreme Court has heard oral arguments and read the briefs—it’s likely that whatever opinion is issued will reflect at least some of the arguments presented to the Court.

This case is about the Affordable Care Act’s requirement that employers who offer their employees health insurance must include ten essential benefits, including contraception.  Hobby Lobby and Conestoga Wood are privately held, for-profit companies whose owners have sincerely held religious objections to providing four specific kinds of contraception.  They believe these contraceptives terminate rather than prevent pregnancy.  Many religious organizations and companies have gotten exemptions to these requirements, but this case considers whether private, for-profit companies should qualify as well.

The cases raise three major issues:

  1. Does the Religious Freedom Restoration Act apply to corporations even though it uses the word “person?” (Can companies have religious beliefs?)
  2. Is providing insurance that covers birth control a “substantial burden?” on these two company’s’ religious beliefs?
  3. Does the government have a compelling reason for requiring companies that provide insurance to have it cover birth control?

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#BELHP2014 Panel 2, Potential Problems and Limits of Nudges in Health Care

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[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

By Matthew L Baum

In this next installment of today’s live-blogging of the conference (and with all of the caveats of live-blogging mentioned by my colleagues and my apologies for any errors or misrepresentations) we have Professors David Hyman (DH), Mark White (MW) and Andrea Freeman (AF) in a panel moderated by Glenn Cohen (GC) on the “Potential Problems and Limits of Nudges in Health Care”.

The panel began with DH, H. Ross & Helen Workman Chair in Law and Director of the Epstein Program in Health Law and Policy, University of Illinois College of Law, and a talk entitled, “what can PPACA teach us about behavioral law and economics” (Patient Protection and Affordable Care Act). DH began with the observation that nudges often work quite well… “unless they don’t”. While many nudges are “sticky”, i.e. they influence behavior in the way they were intended, others are “slippery”, i.e. they fail to influence behavior in the way they were intended. His talk set out to illustrate the phenomenon, and to pose two questions. The first was an empirical question: what makes a nudge sticky vs slippery? The second was philosophical: is it meaningful to talk about a “failed nudge” or when we do, do we really just mean failed marketing? He focused on an analysis of PPACA as a case study.

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Action of Ohio Controlling Board on Medicaid Expansion

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According to Professor Wilson R. Huhn of the University of Akron School of Law, the Ohio governor’s action expanding Medicaid in Ohio is valid. He writes:

On Monday, October 22, at the urging of Governor Kasich, the  Controlling Board of the Ohio Legislature voted 5-2 to accept $2.5  billion in federal funding to expand Medicaid in the State of Ohio.  Under the laws of Ohio this action was valid.

The Controlling Board is a state agency created by statute. The agency  has two principal powers: it can transfer funds and authorize purchases  by state agencies, and it can decide to accept federal funding on behalf of these agencies. Section 131.35(A)(5) of the Ohio Revised Code  states: “Controlling board authorization for a state agency to make an expenditure of  federal funds constitutes authority for the agency to participate in the federal program providing the funds ….”

Two advocacy organizations (the Buckeye Institute and the 1851 Center  for Constitutional Law) as well as several Ohio lawmakers have announced that they intend to challenge the legality of the action of the  Controlling Board. They contend that the action of the Board violates  Section 127.17 of the Ohio Revised Code, which provides that the Board  is bound by the intent of the Ohio General Assembly. The challengers  quite correctly point out that both houses of the General Assembly voted not to accept federal funding to expand Medicaid. Governor Kasich  vetoed this bill, but the challengers argue that despite the Governor’s  veto it’s clear that the General Assembly did not want the Controlling  Board to accept federal funding to expand Medicaid.

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Medical Malpractice, the Affordable Care Act and State Provider Shield Laws: More Myth than Necessity?

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By Mary Ann Chirba and Alice A. Noble

Given the ambitions and reach of the Affordable Care Act, confusion about its intended and inadvertent impact is inevitable. Since its enactment in 2010, the ACA has raised legitimate and less grounded concerns among various stakeholders ranging from individuals and employers facing coverage mandates to States deciding whether and how to implement the Act’s Medicaid expansions. One item has received far less attention even though it weighs heavily on any provider engaged in the clinical practice of medicine: the ACA’s impact on medical malpractice liability. The Act does little to address medical malpractice head on. Nevertheless, physicians and other providers, the states and even some members of Congress have expressed concern that the Act will increase a provider’s exposure to medical malpractice liability.

In response, the American Medical Association has drafted model legislation to shield providers from newly created malpractice claims resulting from the ACA. It would prevent malpractice claimants from using federal or state practice guidelines, quality measures, reimbursement criteria and the like to establish or define the standard of care without expert testimony. In Congress, a version of this model, H.R. 1473, was introduced in the House of Representatives in 2012, and again in April of 2013 [link: https://beta.congress.gov/bill/113th-congress/house-bill/1473/cosponsors].

In April, the governor of Georgia signed H.B. 499 [link: https://www.legis.ga.gov/legislation/en-US/display/20132014/HB/499] into law, becoming the first state to pass legislation based on the AMA model act.

This came on the heels of a Medical Association of Georgia Advocacy Brief [link: https://www.mag.org/sites/default/files/downloads/issue-brief-provider-shield2-2013.pdf] stating that the ACA’s “guidelines” concerning health care quality measures; payment adjustments; hospital value-based purchasing; and value-based payment modifiers “will raise [the medical malpractice] standard to unreasonable levels by exposing physicians to a number of new liabilities….” [Emphasis added]

It is too early to tell whether states will follow Georgia’s lead and enact similar measures. What is clear is that such “standard of care protection” or “provider liability shield” legislation raises interesting questions about the ACA’s impact on state medical malpractice law.

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Big Data and Pharmacovigilance, Part I

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By Dov Fox

So much new data are created every day that 90 percent of all data worldwide has emerged in just the last two years. This information revolution has the potential, argues Bill of Health guest blogger Ryan Abbott, to transform how we develop new drugs, set clinical practices, and finance health care. His interesting new article paints an alluring “vision of a drug regulatory system powered by big data”:

“When the Food and Drug Administration (FDA) approved the cholesterol-lowering drug simvastatin in 1991, it was based on pre-marketing controlled clinical studies that included a total of 2,423 patients. In 2011 alone, just in the United States, almost a hundred million prescriptions were written for the drug. Imagine the impact of being able to analyze data from every one of those patients to evaluate whether simvastatin is safe and effective.”

The surveillance of pharmaceuticals after they’ve gone to market will matter more and more, Abbott argues, as personalized medicines become more difficult – and perhaps less necessary – to regulate before they’re released. He proposes a new plan for the post-market regulatory system that relies on the health information exchanges (HIE) created by the HITECH and Affordable Care Acts. These exchanges are slated to amass a vast repository of data on individual patients. Their large size and inclusive nature will enable more accurate analyses in observational research, Abbott suggests, and in ways that minimize the bias and selectivity problems associated with current data sets.

There are at least three obstacles to the integration of these exchanges in drug regulation. First, HIEs will be expensive. While the federal government provided considerable funding to get these exchanges off the ground, Abbott recognizes that in order to remain viable, they will probably have to sustain themselves financially. Second, their meaningful impact on post-marketing surveillance will require consistent reporting standards and information-sharing mechanisms. Third are important patient concerns about the privacy of their personal health information. States are experimenting with different patient participation models to address privacy concerns. For example, Abbott notes that in some states HIEs are free to exchange information without patient consent, while in others patients can opt-out of information exchange altogether. Either is permitted by HIPAA, so long as the information is de-identified so it can’t be used to identify individual patients.

Abbott argues that it’s worth tackling such concerns that the adoption of HIEs pose for citizens, policy makers, health care providers, and the health care industry, so we don’t squander the opportunity to use health information exchanges to their full benefit. Public support for data collection isn’t enough. That data must be translated into a format that regulators can use—something I’ll address tomorrow in my next post on the subject.