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Executions, Doctors, The U.S. Supreme Court, And The Breath Of Kings


March 26th, 2015

Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

The relationship between medicine and capital punishment has been a persistent feature of this past year in health law, both at the level of medical ethics and Supreme Court review.

Our story starts in Oklahoma, where the execution of Clayton Lockett was botched on April 28, 2014. NIH bioethicist Seema Shah described the events in question:

Oklahoma was administering a new execution protocol that used the drug midazolam, a sedative that is often used in combination with other anesthetic agents. Oklahoma had never used this drug in executions before; in fact, only a few states had experience with using the drug in lethal injection. Florida had previously used this drug in lethal injections, but with a dose five times higher than what was indicated in Oklahoma’s protocol. If the execution had gone as planned, Clayton Lockett would have first received midazolam; been declared unconscious, then received vecuronium bromide (a paralytic/neuromuscular blocking agent that would restrict his movements), and finally received potassium chloride (the drug likely to end his life). A few minutes after officially being declared unconscious, Lockett mumbled statements including the word, “Man.” He “began breathing heavily, writhing, clenching his teeth and straining to lift his head off the pillow.” Prison officials prevented the witnesses from seeing the rest of the proceedings by closing the curtains. The Department of Corrections then called off the execution and unsuccessfully tried to resuscitate Lockett, and Lockett eventually died of a heart attack more than 45 minutes after the execution began. Although a Department of Corrections official stated that Lockett’s veins “exploded,” an autopsy examination performed by a forensic pathologist hired by death row inmates appears to contradict official reports. This report concluded that even though prison officials decided to inject the drugs into Lockett’s femoral vein (which is a more difficult and risky procedure), Lockett’s surface and deep veins had “excellent integrity.” Another execution that was scheduled to occur that same night has now been stayed for six months, pending an investigation into Mr. Lockett’s execution.

On July 23, 2014, Arizona encountered a problem with the same drug in the execution of Joseph Wood, wherein the condemned inmate allegedly gasped for almost two hours before dying.

The executions have prompted two important but different kinds of responses. In this post I write about the role of medical ethics and the U.S. Supreme Court’s response.

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Unpacking The Burr-Hatch-Upton Plan


March 24th, 2015

Anticipating the upcoming Supreme Court decision on King v. Burwell, which could halt health insurance subsidies available through the federal exchange, Republican Senators Richard Burr and Orrin Hatch joined with Representative Fred Upton to propose a comprehensive replacement for the Affordable Care Act (ACA). The Patient Choice, Affordability, Responsibility, and Empowerment Act, or Patient CARE Act, is modeled on a proposal of the same name offered last year by Senators Burr, Hatch, and Tom Coburn, who has retired from the Senate. The Burr-Hatch-Upton plan, like its predecessor, adopts consumer-based reforms of the insurance market, modernizes the Medicaid program, and makes other changes intended to lower cost and increase choices.

In an earlier post, we described in detail the provisions of the Burr-Coburn-Hatch bill. In this post, we discuss how the Burr-Hatch-Upton plan differs from the earlier proposal. We also discuss the impact of the new proposal on health insurance coverage, premiums, and the federal budget based on a new analysis from the Center for Health and Economy (H&E), a non-partisan think tank focused on producing informative analyses of trends in U.S. health care policy and reform ideas. We conclude by commenting on the direction Republicans are likely to take in reforming the health system in the aftermath of a Supreme Court decision in the King v. Burwell case.

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A Check-Up On Dental Coverage And The ACA


March 24th, 2015

Oral health is an important but often overlooked part of health and insurance coverage. State Medicaid and the Children’s Health Insurance Program (CHIP) are required to cover children’s dental services (and children’s access to care has been improving over the last ten years), but coverage for adults is optional. As noted in a recent Health Affairs GrantWatch Blog post, only about 15 states offer extensive coverage for adult dental services in Medicaid.

Medicare does not cover most dental services. And most private dental coverage is offered through stand-alone dental products that are separate from medical plans. Overall, this has resulted in more than 2.5 times as many Americans going without dental coverage as medical coverage.

Inadequate access to dental care is costly. Many low-income individuals turn to the emergency department as their primary and only source of care for oral health needs. The American Dental Association estimates that emergency room visits for avoidable oral health-related visits cost the U.S. health care system as much as two billion dollars per year. A recent Narrative Matters feature in Health Affairs (“Navigating Veronika”) highlighted the steep barriers that low-income individuals can face in navigating the dental safety net and finding a provider who will treat them, even when Medicaid covers the costs of care.

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What Kind Of Advance Care Planning Should CMS Pay For?


March 19th, 2015

Currently, Medicare does not offer a paid benefit for advance care planning (ACP). As a result, health care providers who want to assist Medicare enrollees with ACP do so voluntarily and neither they, nor their institutions, are compensated for their time and efforts. This is not only an unfair expectation on individual practitioners or health institutions, it is also medically and ethically unsound. Fortunately, two recent events have the potential to reshape the landscape of advance care planning in the U.S.

Cultural And Policy Evolution In Advance Care Planning

On September 17, 2014, the Institute of Medicine (IOM) published Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. The report is built on two basic premises:

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Moving In Reverse? Potential Coverage Impacts For Children Of King v. Burwell, Medicaid And CHIP Eligibility Changes


March 17th, 2015

Over the last three decades, the US has taken important steps to reduce financial barriers to health insurance coverage for low and moderate-income children. These steps began with the Medicaid expansions for children in the 1980s and early 1990s, which were followed by the creation of the Children’s Health Insurance Program (CHIP) in 1997. Most recently, Congress reauthorized CHIP in 2009 and enacted the Affordable Care Act (ACA) in 2010.

This commitment to children has resulted in substantial increases in coverage. The uninsured rate among children decreased from 15.0 percent in 1989 to 6.6 percent in 2012 (Exhibit 1).

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The Latest Health Wonk Review


March 17th, 2015

Check out Wright on Health, where Brad Wright has a Spring Forward edition of the Health Wonk Review. Brad’s Review, which more than makes up for the lost hour of sleep, cites Health Affairs Blog’s set of posts on the King v. Burwell oral arguments. Brad links to Tim Jost’s post, which in turn links to posts by Sara Rosenbaum, Ilya Shapiro, Bill Sage, and Grace-Marie Turner.

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Should Health Lawyers Pay Attention To The Administration’s Privacy Bill?


March 13th, 2015

Health care lawyers justifiably ignored the 2012 Obama administration consumer privacy framework because it expressly and broadly exempted entities subject to HIPAA, stating “To avoid creating duplicative regulatory burdens, the Administration supports exempting companies from consumer data privacy legislation to the extent that their activities are subject to existing Federal data privacy laws.”

In contrast, the administration’s 2015 draft bill, the Consumer Privacy Bill of Rights Act, though based on that framework, substantially affects health care entities, including those subject to HIPAA, and so demands more attention in the health law community.

The “HIPAA clause” in the draft bill is subtly different (and noticeably narrower than its preemption of state law clause): “If a covered entity is subject to a provision of this Act and a comparable provision of a Federal privacy or security law [the list includes HIPAA] such provision of this Act shall not apply to such person to the extent that such provision of Federal privacy or security law applies to such person.”

The “provision” wording is key; most of the key substantive provisions in the draft bill—those going to consent, withdrawal of consent, context, and data minimization—do not crosswalk to any comparable provisions in HIPAA. For HIPAA mavens this has the potential of “more stringent than” all over again, but at a higher stakes table. (For nonmavens, this refers to questions raised by HIPAA’s language leaving intact state laws “more stringent than” HIPAA’s privacy protections.)

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Physician Aid In Dying: Whither Legalization After Brittany Maynard?


March 12th, 2015

Editor’s note: This post is part of a series stemming from the Third Annual Health Law Year in P/Review event held at Harvard Law School on Friday, January 30, 2015. The conference brought together leading experts to review major developments in health law over the previous year, and preview what is to come. A full agenda and links to video recordings of the panels are here.

Brittany Maynard’s highly publicized decision to end her life under Oregon’s Death With Dignity law has given a new face to the American right to die movement. It is that of a young, attractive, athletic newlywed, who would not have considered herself as having a stake in the movement until the day she learned a brain tumor was the cause of her severe headaches. She was terminally ill and faced a future of six months of increasing pain, debilitation, and severe seizures before dying.

A video of Maynard’s story produced by the non-profit advocacy organization Compassion and Choices has reached many millions of viewers. Extended coverage of her decision-making process by People Magazine resulted in record numbers of hits to the publication’s website. During her illness, Maynard moved from California to Oregon and on November 1, 2014 took barbiturates to end her life. In her memory, her husband and mother have become prominent activists in the effort to legalize physician aid-in-dying (PAD).

Is all of this likely to advance the PAD movement and, if so, through what legal processes?

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Implementing Health Reform: Supreme Court Remands Contraceptive Case; ACA Cost Estimates Go Lower


March 10th, 2015

On March 9, 2015, the Supreme Court waded once again into the waters of the Affordable Care Act, or at least got its toes wet.  The Supreme Court granted certiorari in Notre Dame v. Burwell, vacated the decision of the federal Court of Appeals for the Seventh Circuit, and remanded the case for reconsideration in light of Hobby Lobby v. Burwell.  Both Hobby Lobby and Notre Dame, of course, involve the regulations that require health plans and insurers to provide contraceptive services to female employees and students.

Also on March 9, 2015, the Congressional Budget Office issued its March, 2015 baseline report.  The CBO and the Joint Committee on Taxation (JCT) now project that the major insurance provisions of the ACA will cost $1.2 trillion over the period 2016-2025, $144 billion less than it projected in January, 2015.  Current projections for the years 2015-2019 are over $200 billion less than costs projected in 2010 when the law was adopted, while projected costs for 2019 are $56 billion, or 33 percent, lower.  The CBO also projects, however, that the ACA will reduce the number of uninsured by 25 million by 2025 rather than the 27 million it had projected in January.

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New Health Policy Brief: Right-To-Try Laws


March 10th, 2015

A new policy brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) looks at so-called Right-to-Try laws. For patients with serious, potentially life-threatening diseases, current federal regulations offer two routes to gain access to experimental drugs not yet approved by the Federal Drug Administration (FDA): participation in a clinical research trial, or, if not possible, applying to the FDA for use of a drug under the expanded access (also known as compassionate use) program.

While the FDA has approved nearly all of these applications, the process is widely thought to be overly cumbersome. Since last year, five states have enacted their own Right-to-Try laws, with the aim of giving critically ill patients the treatments they seek. This health policy brief provides background on the federal regulations of expanded access and the recent involvement by many states.

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Who Authored Obamacare’s Exchanges? King v. Burwell And Justice Kagan’s Law Clerks


March 6th, 2015

Editor’s note: Watch Health Affairs Blog for more posts on King v. Burwell and the Supreme Court oral arguments in the case by Tim Jost, Grace-Marie Turner, Sara Rosenbaum, Bill Sage, and others.

Despite all the media hubbub and intense scrutiny, we didn’t learn all that much from the oral argument in King v. Burwell. The four liberal justices—Ginsburg, Breyer, Sotomayor, and Kagan—clearly believe that an exchange established “for” or “in” a state by the federal government is the same as an exchange “established by the state” (or at least that it’s ambiguous and the tie goes to the IRS). Justices Scalia and Alito—and presumably the silent Thomas—equally believe that words mean what they say.

So the case, as expected, turns on the views of Chief Justice Roberts and Justice Kennedy, who gave very little away. Indeed, I’ve never seen John Roberts so quiet at an oral argument—holding his cards so close that they risk being permanently imprinted on his vest—while Anthony Kennedy was characteristically inscrutable. In other words, 4-3 in the government’s favor with two wild cards.

That’s exactly what everyone knew going into the argument, and 85 minutes later if anyone tried to tell you that they knew what the outcome would be, they were engaging in spin or wishful thinking. To put an even finer point on it: whichever side you thought had the better chance of winning, downgrade your expectations to 50-50.

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Four Words Or 17 Syllables: Predicting King v. Burwell In Haiku


March 5th, 2015

Editor’s note: Watch Health Affairs Blog for more posts on King v. Burwell and the Supreme Court oral arguments in the case by Tim Jost, Grace-Marie Turner, Sara Rosenbaum, and others.

The resolution of King v. Burwell boils down to a simple point. A majority of the Supreme Court is willing to interpret the language of the Affordable Care Act. It is unwilling to rewrite that language.

It is all about four words: Whether “established by the state” in one section of the ponderously long, hastily passed health reform law renders low-income residents of states that have not created their own insurance exchanges but participate in federal exchanges ineligible for federal tax credits. If this is indeed the law, many middle-class families will be unable to afford coverage, residents of states that rely on federal exchanges will pay billions to the IRS for the benefit of those living elsewhere, premiums in those exchanges will rise as enrollment of healthy individuals drops, and the ACA will be unable to achieve its undisputed core purpose of health insurance for all Americans.

In contrast to the media cacophony leading up to yesterday’s hearing in the Supreme Court, the oral arguments themselves were clear and lawyerly. They were also undramatic. Most of the Justices knew where they stood, forcing plaintiff’s counsel Michael Carvin – who spoke first – to hear answers from the bench more often than he was asked actual questions. The Court’s willingness to listen had increased by the time Solicitor General Donald Verrilli took the podium on behalf of the government, and he proved himself an organized and articulate presenter. The only jurists not revealing their positions were Justice Kennedy, who challenged both lawyers on several points, and Chief Justice Roberts, who said little except to maintain order and decorum. (Justice Thomas famously refrains from participating in oral argument, but usually votes with Justice Scalia.)

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King v Burwell: The NFIB Medicaid Coercion Argument Returns


March 5th, 2015

Editor’s note: Watch Health Affairs Blog for more posts on King v. Burwell and the Supreme Court oral arguments in the case by Tim Jost, Grace-Marie Turner, and others.

The March 4, 2015 oral argument in King v Burwell, which will determine whether millions of low- and moderate-income Americans will continue to have access to affordable health insurance coverage, revealed a United States Supreme Court very much in play.  In this climate, observers inevitably are paying heightened attention to each of the many parries and thrusts that unfolded over more than an hour of rapid give-and-take between the Justices and the lawyers, as they battled over the meaning of 4 words in a 1000-page statute.

Perhaps no exchange will receive more attention than the one between Justice Anthony Kennedy and Michael Carvin (representing the challengers) that took place approximately 5 minutes into his argument.  It was Justice Sotomayor who actually kicked things off with the following observation:

The choice the state had was to establish [an] Exchange or let the Federal government establish it. . . .That was the choice.  If we read [the statute] the way you’re saying, then we’re going to read a statute as intruding on the Federal-State relationship, because then the States are going to be coerced into establishing their own Exchanges. . . Tell me how that is not coercive in an unconstitutional way?  And if it is coercive in an unconstitutional way [isn’t there] a primary statutory command that we read a statute in a way where we don’t impinge on the basic Federal-State relationship?

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King v. Burwell: Finding A Path Forward After An Executive Overreach


March 5th, 2015

Editor’s note: Watch Health Affairs Blog for more posts on King v. Burwell and the Supreme Court oral arguments in the case by Tim Jost and others.

The Supreme Court justices had a lively discussion today during arguments in King v. Burwell about who Congress intended to get health insurance subsidies and under what conditions.

The central question is whether the Internal Revenue Service had the authority to write a rule authorizing subsidies to go to millions of people in the 37 states now operating under federal exchanges.

The plaintiffs say the language of the law is clear:  Subsidies are allowed in “an Exchange established by the State under [section] 1311of the Patient Protection and Affordable Care Act.” It doesn’t just say this once, but nine times in various linguistic forms.

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King v. Burwell: Unpacking The Supreme Court Oral Arguments


March 5th, 2015

Editor’s note: Watch Health Affairs Blog for more posts by Grace-Marie Turner and others on King v. Burwell and the Supreme Court oral arguments in the case.

One March 4, 2015, the United States Supreme Court heard oral arguments in King v. Burwell.  As every reader of this Blog knows, the issue in the case is whether the Internal Revenue Service rule that allows the federally facilitated marketplaces to grant premium tax credits is valid.

If it is not, millions of individuals in the 34 states served by the FFMs will lose their tax credits.  Without the credits, they will no longer be able to afford health insurance.  The cost of insurance to those remaining in the nongroup market will rise precipitously, causing even more Americans to lose coverage.  As the number of uninsured increases, providers will bear an increased burden of uncompensated care.  A decision for the plaintiffs, that is, will be disaster for the American health care system.

The challengers argue that this is a result Congress intended.  They contend that the subsection of the Affordable Care Act dealing with the calculation of premium tax credits limits the credits to individuals enrolled in an “Exchange established by the State.”  The government argues that this is a term of art — that Congress intended this phrase to include the federally facilitated exchanges that the ACA requires the Department of Health and Human Services to create as a fallback where the states elect not to operate their own exchange.  Dozens of other provisions of the ACA support the government’s position.

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The ACA’s Hospital Tax-Exemption Rules And The Practice Of Medicine


March 3rd, 2015

The Affordable Care Act (ACA) and related regulations include obligations for nonprofit (and some government) hospitals to provide benefits, such as free care, to their communities. On their face, these new obligations seem a valuable response to longstanding concerns of some legislators, litigators, and scholars that some nonprofit hospitals are really ‘for-profits in disguise’ and to the related calls to eliminate tax-deductions for gifts to nonprofit hospitals. Moreover, the requirements have been lauded for their potential to improve public health, particularly in leading to better consultation and collaboration with local public health officials.

However, the new requirements are likely to have unintended, undesirable consequences. In particular, the amount that hospitals will spend on new services may be substantial, and that could ultimately affect how medicine is practiced.

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Health Affairs’ March Issue: The Benefits And Limitations Of Information


March 2nd, 2015

The March issue of Health Affairs contains papers focusing on the benefits—and the limitations—of information-gathering processes as a way to solve health system problems. Studies in this variety issue examine US hospital rating systems, disclaimers on dietary supplements, state prescription drug monitoring programs, the value of US versus Western European cancer care and other topics.

National hospital rating systems show little agreement — what’s a consumer to do?

Matt Austin of Johns Hopkins Medicine and coauthors compared four well-known national hospital rating systems designed for use by US consumers: U.S. News & World Report’s Best Hospitals; HealthGrades’ America’s 100 Best Hospitals; Leapfrog’s Hospital Safety Score; and Consumer Reports’ Health Safety Score. They analyzed ratings covering the time period from July 2012 to July 2013.

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From The Supreme Court: A Strong Endorsement Of Health Care Competition


March 2nd, 2015

The Supreme Court has spoken by a 6-3 vote, with Justice Anthony Kennedy writing an opinion for the Court joined by Chief Justice Roberts and Justices Breyer, Ginsburg, Sotomayor, and Kagan.  In a strong, clear voice, the Court upheld the enforcement of a major federal statute against a state entity that had failed to embrace federal policy with respect to health care.  Although not formally a constitutional decision, the Court’s interpretation of congressional intent played out against the backdrop of an important constitutional question: the permissible and appropriate balance between federal lawmaking and residual state authority.  And it was the federal government’s seeming disregard of state sovereignty that led what has become the Court’s conservative rump – here Justice Alito, joined by Justices Scalia and Thomas – to write bluntly in dissent.

The case is North Carolina State Board of Dental Examiners v. Federal Trade Commission, not King v. Burwell, and the major federal statute is the Sherman Antitrust Act, not the Affordable Care Act.  Oral argument in North Carolina State Board took place last October (David Hyman and I wrote about it here); the Court’s decision was issued on February 25, 2015.

North Carolina State Board has nothing to do with “Obamacare,” but it may turn out to be the most important health care (and general public law) decision of the year.  (Note to Pundits and Hypesters: King v. Burwell will only matter if the Court rules for the plaintiffs, and is unlikely to create enduring law even then. If the government wins, the case will soon be forgotten.)  The Supreme Court’s ruling will give professional licensing boards throughout the country significant pause before adopting ad hoc policies that disadvantage competing professionals or non-professionals, and it should lead to a constructive conversation (and perhaps uniform or model legislation) regarding the accountability of self-regulatory bodies to actual state government.  Its impact could be comparable to a major revamping of Joint Commission standards for health care facilities – low in visibility but dramatic in operational change.

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How Many Americans Will Lose Coverage If The Supreme Court Kills The ACA Tax Credits?


March 2nd, 2015

In March, the U.S. Supreme Court is slated to hear King v. Burwell, a case that challenges the authority of the federal government to provide tax credits and other financial assistance to people who buy Affordable Care Act (ACA) coverage through the federal health insurance marketplace. The federal government runs the health insurance marketplace in 34 states where states chose not to set up a state-based exchange.

Estimates on how many people could lose tax credits in these 34 states vary widely from 4.5 million to 13 million. After talking to executives and lobbyists for health care related entities in 20 of the 34 states affected, I believe that about 6.5 million people who have tax credits in 2015 will lose them. The difference in these numbers will be important to policymakers, since politicians are likely to make decisions on how to respond to a Court ruling based on the actual number of their constituents who are receiving tax credits or other support.

In addition, the impact of a Court ruling will be affected by state action. Some observers have questioned whether states will set up exchanges if the Court eliminates tax credits from the federal exchange. These observers have said that establishing a state exchange is costly and time consuming and that most federal exchange states will not take this step. I argue in the following post that setting up a state exchange could be easy and inexpensive if the federal exchange operations are used.

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New Health Policy Brief: Risk Corridors (Updated)


February 26th, 2015

The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) provides an update to an earlier brief on the Affordable Care Act (ACA)’s risk corridor program, which allows the Department of Health and Human Services (HHS) to collect and make payments to qualified health plans. As the brief explains, a recent amendment to federal appropriations raises questions as to whether insurers will receive their full risk corridor payments for 2014.

While the Consolidated and Further Continuing Appropriations Act of 2015, which funded the government for the 2015 fiscal year, did give HHS the authority to collect user fees, an amendment was included that specifically prohibited HHS from transferring money from either trust fund.

The amendment did not eliminate the risk corridor program, nor did it prevent HHS from using payments received from insurers to pay out claims under the program (that is, user fees), but it effectively made the risk corridor program budget neutral unless HHS can find another source of funding. As a result, insurers expecting payments from HHS may not receive the full amount due.

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