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


January 22nd, 2015

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.

The event is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School and the New England Journal of Medicine, and co-sponsored by Health Affairs, The Hastings Center, and the Center for Bioethics at Harvard Medical School. Below, we will highlight a few themes that have emerged so far. The conference’s speakers will author a series of posts that follow on more specific topics.

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The Lame Duck Device Tax?


January 5th, 2015

In a recent Health Affairs Blog post, I explored the types of changes that might be made to the Affordable Care Act (ACA) if and when Congress decides to revisit the law in a bipartisan manner. While that day is likely still some years away, Republican control of the Senate next year does raise the probability we’ll see action on some more central elements of President Obama’s signature domestic policy achievement.

While there has been considerable scrutiny, and bipartisan concern, about the employer mandate and the manner in which full-time employees are calculated for purposes of compliance with the ACA, for example, there has arguably been no steadier drum beat for repeal of a section of the health care law than for the medical device tax.

Senators Hatch, Coburn, and Burr, for example, in their influential repeal and replace proposal, would strike the medical device tax (along with others under the new law). Perhaps more telling, however, is the fact that 34 Democrats, including Senate leadership members Schumer, Durbin, Murray, Klobuchar, and Warren, cast a nonbinding vote to repeal the policy as recently as September 2014.

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Rethinking The Gruber Controversy: Americans Aren’t Stupid, But They’re Often Ignorant — And Why


December 29th, 2014

M.I.T. economist Jonathan Gruber, whom his colleagues in the profession hold in very high esteem for his prowess in economic analysis, recently appeared before the House Committee on Oversight and Government Reform. Gruber was called to explain several caustic remarks he had offered on tortured language and provisions in the Affordable Care Act (the ACA) that allegedly were designed to fool American voters into accepting the ACA.

Many of these linguistic contortions, however, were designed not so much to fool voters, but to force the Congressional Budget Office into scoring taxes as something else. But Gruber did call the American public “stupid” enough to be misled by such linguistic tricks and by other measures in the ACA — for example, taxing health insurers knowing full well that insurers would pass the tax on to the insured.

During the hearing, Gruber apologized profusely and on multiple occasions for his remarks. Although at least some economists apparently see no warrant for such an apology, I believe it was appropriate, as in hindsight Gruber does as well. “Stupid” is entirely the wrong word in this context; Gruber should have said “ignorant” instead.

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Sovaldi, Harvoni Payment Issues Lead Health Affairs Blog November Most-Read List


December 24th, 2014

A piece by Laura Fegraus and Murray Ross on the challenges of paying for lifesaving but high-priced drugs like Sovaldi and Harvoni from was the most-read Health Affairs Blog post for November. This was followed by a critical analysis of workplace wellness programs from Al Lewis, Vik Khanna, and Shana Montrose.

Next came a post on the 2016 Notice of Benefit and Payment Parameters Proposed Rule from Tim Jost, and then a look at health care policy after the mid-term elections from James Capretta.

The full top-ten list for November is below.

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Implementing Health Reform: Beneath The Hood Of The ‘Cromnibus’


December 12th, 2014

The “Consolidated and Further Continuing Appropriations Act, 2015” or “Cromnibus” legislation moving through Congress contains a number of provisions that relate to the implementation of the Affordable Care Act (ACA).

Risk Corridors

The provision that has been most widely noted so far requires the risk corridor program to be budget neutral for 2014. The risk corridor program moves funds from qualified health plans (QHPs) that have lower than anticipated allowable costs to those with higher than anticipated allowable costs. Section 1342 of the ACA, which creates the risk corridor program, contains no explicit appropriation.

A report issued earlier this year by the Government Accountability Office (GAO), which is the final authority on the legitimacy of government expenditures, determined that the continuing resolution for 2014 permitted the Centers for Medicare and Medicaid Services (CMS) to fund the risk corridor program for 2014 both from payments collected from plans with lower than anticipated costs, which were properly characterized as user fees, and from funds transferred from other CMS accounts. No risk corridor payments were in fact payable in 2014, however, as risk corridor payments will first be made in 2015 for 2014.

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Two Theologies Have Blocked Medicare-For-All


December 11th, 2014

Editor’s note: This post is part of a series of several posts stemming from presentations given at “The Law of Medicare and Medicaid at Fifty,” a conference held at Yale Law School on November 6 and 7.

In the 50 years since Medicare was enacted, Congress has never seriously considered extending Medicare to all Americans, nor even lowering Medicare’s eligibility age below 65. This pattern persisted even during those periods when national health insurance was at the top of the national agenda. This is not what the original advocates of Medicare anticipated when Medicare was enacted in 1965. They saw Medicare as the cornerstone of a national system of health insurance that would eventually cover all Americans.

Two Myths that Undercut Medicare-for-All: Managed Care and Competition

In the paper we presented at the Yale conference, we reviewed short- and long-term factors affecting the debate about Medicare over its lifetime, and then turned to a discussion of two long-term factors: the rise of what came to be called the managed care movement, and the resurgence of a longstanding campaign promoting the idea that competition can right the wrongs of American medicine.

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The Council On Graduate Medical Education (COGME)—Not Yet Ready For End-Of-Life Care


December 4th, 2014

In November, 1985, twenty-nine years ago, members of the first session of the 99th Congress addressed growing concern and controversy regarding Graduate Medical Education (GME). Although Medicare had financed GME for the previous twenty years, Congress began to recognize that our rapidly evolving health care system could require significant changes in the composition of our physician workforce, and that these changes could impact the appropriate governance and funding of GME.

In this setting, the Council on Graduate Medical Education (COGME) was conceived and underwent rapid gestation, with its birth achieved via enactment of authorizing legislation in 1986. Its charter charged the Secretary of Health and Human Services (HHS), under Title VII of the Public Health Service Act, with responsibility for taking national leadership in the development of policies related to GME, and in the research, development, and analysis of such policies that impact on the health workforce needs of the nation. COGME was instructed to provide advice and make policy recommendations to the Secretary and committees of the House and Senate within their jurisdiction.

Contrary to a sunset provision in the legislation, COGME still survives. While continuing to function on very limited support, it recently issued a noteworthy report entitled “Improving Value in Graduate Medical Education” in 2013. COGME presently is preparing its 22nd Report, which addresses the need for change in GME due to changes in the U.S. health care system and focuses on opportunities to improve training through more effective targeting of public resources.

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Medicare, Medicaid, And Pharmaceuticals: The Price Of Innovation


November 20th, 2014

Editor’s note: This post is part of a series of several posts stemming from presentations given at “The Law of Medicare and Medicaid at Fifty,” a conference held at Yale Law School on November 6 and 7.

Through much of the last half century, Medicare and Medicaid (MM) have not for the most part supported research intended to lead to new drugs. For their role in drug development, we need to look to infrastructure and incentives. The record of the National Institutes of Health (NIH) illustrates the potential of both for pharmaceutical innovation. The current budget of NIH, the big elephant in the zoo of the federal biomedical enterprise, is $30 billion, but apart from a dozen small programs devoted to targeted drug development, most of these billions are not aimed directly at pharmaceutical innovation (See page 234).

Yet the NIH investment in biomedicine has indirectly fueled drug development in the private sector to a huge degree. It has paid for the training of biomedical scientists and clinicians, many of whom went on to staff the drug industry, especially its laboratories. NIH-sponsored research has also generated basic knowledge and technologies and it has encouraged universities to spin out their potentially useful findings into the industry by allowing for the patenting and licensing of the findings.

Like NIH, MM has helped fuel drug development indirectly by supporting selected experimental cancer treatments, medical education, and some clinical research and training. But investment in these activities has been small and their impact on drug development apparently very limited. In contrast to NIH, the MM stimulus to drug innovation has resided not in the production of new scientists or the patented uses of new knowledge, but principally in markets and pricing.

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Dear Governor-Elect: Some Health Policy Counsel


November 18th, 2014

Congratulations on your election on November 3. It is a mandate for your vision and leadership.  Now, like the proverbial dog who has caught the meat truck — where to begin with this business of governing?

As you contemplate the work in front of you, I would like to offer some (unsolicited) advice about a possible state health policy agenda, borne from my own work and observing states across the country. The recommendations are non-ideological and substance-neutral.  You will look hard to find a reference to the Affordable Care Act (ACA) here. The challenges states face in health care are so large they defy simple solutions and require collaboration across our widening ideological divide; energy spent attacking the ACA is energy diverted from these challenges.

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Challenges For People With Disabilities Within The Health Care Safety Net


November 18th, 2014

Medicare and Medicaid were passed to serve as safety nets for the country’s most vulnerable populations, a point that has been reemphasized by the expansion of the populations they serve, especially with regards to Medicaid. Yet, even after 50 years, the disabled population continues to be one whose health care needs are not being met. This community is all too frequently left to suffer health disparities due to cultural incompetency, stigma and misunderstanding, and an inability to create policy changes that cover the population as a whole and their acute and long-term needs.

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Medicaid At 50: From Exclusion To Expansion To Universality


November 14th, 2014

Editor’s note: This post is part of a series of several posts stemming from presentations given at “The Law of Medicare and Medicaid at Fifty,” a conference held at Yale Law School on November 6 and 7.

For almost five decades, Medicaid has been a safety net with gaping holes. Medicaid has provided invaluable health care access for the “deserving poor”—the impoverished blind, disabled, children, pregnant women, and elderly—but they only comprise approximately 40 percent of the nation’s poor. The Patient Protection and Affordable Care Act (ACA), as part of its comprehensive insurance coverage architecture, rendered all Americans earning up to 138 percent of the federal poverty level (FPL) eligible for Medicaid. Through the effort to “provide everybody … some basic security when it comes to their health care,” the ACA adopted a universal approach to health care access. Universality is a fundamentally different philosophical approach in American health care, and an important progression away from the stigmatizing rhetoric of the “deserving poor.”

The Supreme Court nearly thwarted the possibility of universality by holding the Medicaid expansion unduly coercive and rendering expansion optional for the states. Ever since, states have been exercising that option, deciding whether to expand in a highly dynamic dialogue that has occurred both intrastate and extra-state with the Secretary of the Department of Health and Human Services (HHS). This dialogue has resulted in four waves of Medicaid expansion, each of which has exhibited greater boldness on the part of the states in their proposals to HHS, and greater flexibility on the part of HHS in accepting state ideas for expansion. On a spectrum of federalism, the waves move from cooperation to assertions of state sovereignty. But, Medicaid’s new universality provides an absolute backstop for HHS in these negotiations, a point at which federal policy should not accommodate the rent-seeking behavior of the states.

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Health Care Policy After The Mid-Term Elections


November 7th, 2014

As President Obama said in his post-election news conference, Republicans had a good night on November 4. They increased their majority in the House to a level not seen since the 1920s and may hold as many as 250 seats in the lower chamber. In the Senate, Republicans defeated at least three incumbent Democratic Senators, and are likely to defeat two more when all of the voting and counting is over.

The most likely scenario is that the GOP will hold 54 seats in the Senate come January — an increase of nine seats from the current Congress. It is noteworthy that half of the Democratic Senators who voted to pass the Affordable Care Act (ACA) nearly five years ago will no longer be in the Senate in 2015. Despite some commentary to the contrary, the ACA was a big issue in the election. To a person, the successful GOP Senate candidates ran strongly against the ACA. In the middle of October, anti-ACA ads were among the most frequently-aired political advertisements from Republican Senate candidates. By and large, these candidates won their races.

The conventional wisdom is that the ACA, now heading into its second year of full-scale implementation, cannot be rolled back in any substantial way at this point. That’s certainly the view of major corporate players and the health care industry. But it is decidedly not the view of the newly-elected Republican members of the House and Senate, or their constituents. They believe voters sent them to Washington to do their best to push back against the perceived excesses of the ACA and to begin replacing it with a reform plan that is less expensive, less damaging to the economy, and less reliant on federal regulation and control.

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Yes, We Can Transcend Obamacare


November 6th, 2014

In a recent  Health Affairs Blog post, Washington and Lee University law professor Timothy Jost described a new health-reform plan designed by one of us (Roy) and fiscally modeled by the other (Parente) as a “serious proposal [that] deserves to be taken seriously.” Jost praises parts of the plan. Most notably, he writes that its suggested reform of Medicaid “makes a lot of sense and is similar to proposals made earlier by progressive commentators,” and describes its aim of enacting a uniform annual deductible for Medicare as a “common sense proposal.”

But much of Jost’s review is filled with ideological pique—there are various harrumphs about “nostrums” and “talking points” and “hobby horses.” His article contains some factual and analytical inaccuracies, but also a few good points worth discussing.

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Social Insurance Is Missing A Piece: Medicare, Medicaid, And Long-term Care


November 6th, 2014

Editor’s note: This is the first of several periodic posts stemming from presentations to be given at “The Law of Medicare and Medicaid at Fifty,” a conference that will be held at Yale Law School on November 6 and 7. The issues covered in this post and in Professor Feder’s presentation at the conference will be more fully treated in Feder J. “The Missing Piece:  Medicare, Medicaid and Long-Term Care,” in Cohen AB, Colby DC, Wailoo KA, Zelizer JE, eds. Medicare and Medicaid at 50: America’s Entitlement Programs in the Age of Affordable Care. New York: Oxford, 2015.

Medicare and Medicaid are partners in providing health insurance protection to older people and people with disabilities. But when it comes to helping the very same people with long-term care—assistance with the basic tasks of daily life (like bathing, eating and toileting)—no such partnership exists.  Instead, there’s a gaping hole in protection that leaves people who need care, along with their families, at risk of catastrophe.

That hole is not an accident.  From Medicare’s inception, long-term care was explicitly excluded from its social insurance benefits, despite the close tie of many long-term care needs to medical conditions.  With some short-lived lapses, Medicare rules have restricted the program’s benefits to avoid financing long-term care, even as it has overpaid long-term care providers for medically-related “post-acute” services. Ironically, Medicare has fueled growth in expenditures on long-term care providers without actually covering long-term care.

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The Law Of Medicare And Medicaid At Fifty


November 4th, 2014

Editor’s note: This is the first of several periodic posts stemming from presentations to be given at “The Law of Medicare and Medicaid at Fifty,” a conference to be held at Yale Law School on November 6 and 7.

This post introduces an online symposium in connection with The Law of Medicare and Medicaid at 50, an upcoming interdisciplinary conference at Yale Law School.  Many thanks to Health Affairs for its co-sponsorship of the conference and for this opportunity to preview some of the work to be presented.

Why focus on the law of Medicare and Medicaid?  These two programs are almost always analyzed from a policy perspective, but one of the most significant changes that the 1965 legislation wrought was bringing two major federal statutes—and, with them,  the three branches of the federal government—squarely into the center of  health care and regulation.  To be sure, Congress had passed laws related to health prior to 1965, but until Medicare and Medicaid, most health policy was made at the local level, by state courts and state governments, and by the medical profession itself.

Medicare and Medicaid brought not only Congress, but the Supreme Court and the rest of the lower federal courts into the picture. It also made the federal administrative apparatus—federal agencies ranging from Health and Human Services, to Treasury, to the Department of Justice—central players in the world of health policy and enforcement.  Nevertheless, amidst the thousands of pages that have been written about the two programs, there has been relatively little reflection on how the distinct features of law—and federal law in particular—have affected the programs’ development and successes.

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The United States’ Misguided Self-Interest On Ebola


October 31st, 2014

The Ebola epidemic in West Africa is spiraling out of control. The international community allowed a manageable outbreak to mushroom into a health and humanitarian crisis. The World Health Organization (WHO) has been enfeebled and largely sidelined. Belatedly, the United States sent military troops into Liberia and spearheaded a United Nations Security Council resolution. Yet since isolated Ebola cases have appeared on our shores, the US has begun to look inward, at risk of falling into a trap that I will call “misguided self-interest.”

While the West African epidemic rages, the US delayed significant action until long after the unprecedented nature of the Ebola epidemic became clear, and even now the response is incommensurate with the massive need. Now we are transferring our gaze from the real crisis and headed on an insular journey.

I grant the premise that a country’s first responsibility is to protect its inhabitants. But calls for a travel ban from the region and newly announced state quarantine policies that would ensnare travelers from affected countries appear selfish. To put it in perspective, the US has experienced only a few domestically diagnosed cases, with an exceedingly low risk of an outbreak.

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North Carolina Dental Board v. FTC: A Bright Line On Whiter Teeth?


October 30th, 2014

On October 14, 2014, the United States Supreme Court heard oral arguments in North Carolina Board of Dental Examiners vs. Federal Trade Commission.  The case does not involve the Affordable Care Act, but it goes to the heart of the professional self-regulatory paradigm that has governed the U.S. health care system for more than a century.  The specific legal question under review is the standard for determining when a state professional licensing board’s activities are subject to scrutiny for anticompetitive effect under the federal antitrust laws.

Antitrust law applies to private anticompetitive conduct.  Congress did not intend to interfere with state regulation that limits or even eliminates competitions.  As long as states do so using public agencies and officials, they are on safe ground.  If a state empowers private parties to administer such regulation, however, it not only must “clearly articulate” its intent to diminish competition, but also must “actively supervise” the conduct of the private parties.  In previous cases, the Supreme Court developed and elaborated this two-part test, which is called the “state action doctrine.”

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Implementing Health Reform: The Qualified Health Plan Federal Exchange Participation Agreement And More


October 21st, 2014

CMS continues to put the pieces into place that are needed for the launch of the 2015 coverage year.  On October 16, 2014, the Centers for Medicare and Medicaid Services released at its REGTAP.info website the certification agreement and privacy and security agreement that qualified health plan (QHP) insurers must sign with CMS to access the federally facilitated exchange (FFE), the federally facilitated SHOP (FF-SHOP), and CMS Data Services Hub.  The agreement focuses primarily on obligations that the QHP insurer undertakes to protect personally identifiable information and to ensure secure communications with CMS, although it also addresses the effective date and termination of the agreement and a few other issues.  Most of the terms of the agreement are unremarkable, and this post will only comment on a few.

QHP insurers undertake under the agreement to protect personally identifiable information and to ensure secure communications with CMS in conformity with applicable laws, regulations, and standards.  They must also ensure that their contractors and downstream entities comply with these requirements.  QHP insurers agree to report any personally identifiable information incidents or breaches to CMS within 72 to 96 hours.  This is a far cry from the one-hour breach reporting requirement proposed by CMS last year but never finalized, but perhaps recognizes the difficult of identifying and assessing a security breach.

The agreement expressly recognizes that QHP insurers have developed their products based on the assumption that advance premium tax credits and cost-sharing reduction payments will be available through the marketplace and that QHP insurers could have cause to terminate the agreement if this assumption ceases to be valid.  This could be interpreted as a reference to the Halbig/King litigation which currently threatens the availability of tax credits and cost-sharing reduction payments through the FFE, but could also have been included in recognition of the likely Republican takeover of the Senate and the possibility that the Republicans may accomplish through budget reconciliation or otherwise their longstanding goal of repealing the ACA.  As the agreement is renewable from year to year, this clause may contemplate contingencies in the indefinite as well as the near future

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Thomas Frieden And The U.S. Ebola Response


October 20th, 2014

On Friday, October 17, the White House named Ron Klain the new Ebola czar. This move followed a storm of criticism in the media, on Capitol Hill, and elsewhere. The criticism focused on the multiple mistakes made by the U.S. agencies and Texas Health Presbyterian Hospital in Dallas in the weeks since Thomas Eric Duncan, infected with Ebola, arrived in the United States on September 19. Duncan set off a disturbing train of events that included secondary infections of two nurses, Nina Pham and Amber Vinson, along with the lingering threat of additional infections.

That threat widened rapidly over the course of this past week. Dozens of health workers in Dallas remain under some form of quarantine or very close monitoring. Contact tracing revealed 300 persons who had possibly come in contact with Vinson during her Columbus Day weekend travel from Dallas to Cleveland and back. Schools were subsequently shuttered in Ohio and Texas.

Most remarkable, within a month the controversy surrounding the threat of Ebola to Americans had mushroomed into a political emergency for the Obama presidency itself, only a few tense weeks before the November 4 elections. Calls escalated for the appointment of an Ebola czar and a travel ban on persons originating in Liberia, Sierra Leone, and Guinea, the root sources of the Ebola emergency. A special measure of criticism was reserved for the Obama administration’s lead face in the U.S. response, Dr. Thomas Frieden, head of the U.S. Centers for Disease Control and Prevention (CDC). In the words of one observer, this week became full of “recriminations, political showboating… and panicked overreactions.”

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Teaching Health Centers: An Attainable, Near-Term Pathway To Expand Graduate Medical Education


October 17th, 2014

Stakeholders in Graduate Medical Education (GME) and members of Congress eagerly anticipated the long delayed but recently released Institute of Medicine (IOM) GME report. While perceptively characterizing the defects in our GME system, recommendations of the report generated substantial controversy among participants at a recent GME forum hosted by Health Affairs. The IOM proposed limited and gradual changes in Medicare GME financing, but the lack of support for GME expansion was not well received by some.

At present there are multiple legislative GME proposals, but none has gained broad support among the various stakeholders. Congressional committees responsible for GME funding view this lack of consensus among GME stakeholders as a major obstacle.

We describe a near-term and attainable pathway to expand GME that could gain consensus among these stakeholders. This approach would sustain and expand Teaching Health Centers (THCs), a recent initiative that directly funds community-based GME sponsoring institutions to train residents in primary care specialties, dentistry and psychiatry. We further propose selectively expanding GME to meet primary care and other demonstrable specialty needs within communities, and building in evaluations to measure effectiveness of innovative training models.

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