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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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Rethinking Graduate Medical Education Funding: An Interview With Gail Wilensky


September 9th, 2014

A recent Institute of Medicine report has stirred controversy by proposing to significantly reshape the way Medicare graduate medical education funding is distributed. However, before the panel that wrote the report grappled with how the federal government should fund GME, it had to decide whether the federal government should be involved in the area at all.

“We struggled with the rationale [for a federal role] from the first meeting to the last time we convened,” Gail Wilenksy, who co-chaired the panel with Don Berwick, said in a recent interview with Health Affairs Blog.  After all, she said, the federal government “is not in the business of funding undergraduate medical education or other health care professions in any similar way, or funding other professions that are believed to be important to society and in shortage,” such as engineers, mathematicians, or scientists.

GME funding has been discussed at length in the pages of Health Affairs and will be the subject of a briefing sponsored by the journal tomorrow, Wednesday September 10. (Live and archived webcasts will be available for those who cannot attend in person.) Wilensky will offer opening remarks at the briefing. A summary of the GME report is provided in an earlier Health Affairs Blog post by Edward Salsberg, who will also participate in the briefing.

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Transcending Obamacare? Analyzing Avik Roy’s ACA Replacement Plan


September 2nd, 2014

Avik Roy’s proposal, “Transcending Obamacare,” is the latest and most thoroughly developed conservative alternative for reforming the American health care system in the wake of the Affordable Care Act. It is a serious proposal, and it deserves to be taken seriously.

Roy’s proposal is a curious combination of conservative nostrums (limiting recoveries for victims of malpractice), progressive goals (eliminating health status underwriting, providing subsidies for low-income Americans), and common sense proposals (enacting a uniform annual deductible for Medicare).

Most importantly, however, Roy proposes that conservatives move on from a single-minded focus on repealing the ACA toward building upon the ACA to accomplish their policy goals. He supports repealing certain features of the ACA—including the individual and employer mandate—but would retain others, such as community rating and exchanges. As polling repeatedly shows that many Americans are not happy with the ACA, but that a strong majority would rather amend than repeal it, and as it is very possible that we will have a Congress next year less supportive of the ACA than the current one, Roy’s proposal is important.

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Whither CHIP?


August 19th, 2014

In a day all but lost to Affordable Care Act prehistory, on November 7, 2009, the House of Representatives passed the Affordable Health Care for America Act. Among the bill’s many differences with its Senate counterpart, it would have allowed the Children’s Health Insurance Program (CHIP) to expire at the end of 2013, with children covered under that program enrolled in either Medicaid or commercial Exchange plans.

On December 24, the Senate passed the Patient Protection and Affordable Care Act (ACA). Their bill extended CHIP through fiscal year 2015 while, curiously, enhancing the Federal match rate for the program beyond that date and instituting a maintenance of effort (MOE) requirement for states to keep CHIP kids covered through 2019.

At the time, drafters of the respective chamber’s versions of health reform anticipated heading to conference to negotiate and resolve their differences, with the disposition of CHIP one of the top considerations.

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IOM Graduate Medical Education Report: Better Aligning GME Funding With Health Workforce Needs


July 31st, 2014

After nearly two years of deliberation, the Institute of Medicine (IOM) Committee on the Governance and Financing of Graduate Medical Education (GME) has issued its report. It presents a strong case for the need for change and a strong case for its recommendations.

The members of the Committee and the IOM are to be commended for their hard work, vision, and a high quality report. The report presents a clear path to a system that would help produce a physician workforce better aligned with the nation’s needs and a framework for a rational and defensible expenditure of nearly 15 billion dollars in public funds each year on GME.

Issues related to GME financing have been contentious for many years. In 1965, Congress included GME financing under Medicare reimbursement in what was intended to be a temporary arrangement. Nearly 50 years later, we are still trying to find a permanent and more rational way to finance and pay for the training of physicians as an alternative to the current complex, arcane formula built on Medicare inpatient days. Despite the well-documented shortcomings of the current system and numerous studies, attempts to find agreement on how to change and improve GME financing have been unsuccessful.

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Income Verification On The Exchanges: The Broader Policy Picture


July 14th, 2014

The Affordable Care Act scandal de jour (or at least one of them) is the difficulty the exchanges have faced in verifying the eligibility of many premium tax credit applicants. Two Department of Health and Human Services Office of Inspector General Reports in early July documented the existence of these problems. One reported that as of the first quarter of 2014, the federal exchange alone had been unable to resolve 2.6 or 2.9 million data inconsistencies. Another reported that internal controls at the federal and two state exchanges were not fully effective in ensuring that individuals enrolled in exchanges were in fact eligible.

House Republicans claim that in fact there are 4 million data inconsistencies affecting half of all enrollments. In House Energy and Commerce hearings on June 10, 2014, Republican Representative Charles Bustany Jr. claimed that $44 billion in improper payments would be made over the next 10 years. Douglas Holtz-Eakin, a former Bush Administration official, who testified at the hearings claims that improper payments may equal $152 billion. The House Energy and Commerce Health Subcommittee is holding further hearings on data inconsistencies on July 16.

The seriousness of verification issues should not be overestimated. The administration has been put in place procedures to verify carefully premium tax credit applications. Many of the discrepancies CMS is attempting to resolve do not relate to income eligibility, and those that do may result ultimately in a finding of eligibility for increased, rather than decreased, premium tax credits. A discrepancy that could result in the need for additional documentation may be as trivial as a hyphen left out of a name or a digit transposed on a Social Security number.

Unfortunately, programs proposed by Republicans and other ACA opponents that in fact make a serious attempt to cover the uninsured will require income reporting and face similar difficulties. Current reform proposals that avoid coverage eligibility determinations will not in fact cover the uninsured. While the administration could have perhaps done a better job in making eligibility determinations, any means-tested program faces a similar challenge. It is possible to design a system that does not rely on means testing and could cover low-income and high-cost uninsured Americans, as I describe below. But it would be a very different system than the ACA or alternatives currently being proposed.

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A Health Reform Framework: Breaking Out Of The Medicaid Model


July 10th, 2014

Editor’s note: This post is coauthored by Joseph Antos and James Capretta.

A primary aim of the Patient Protection and Affordable Care Act (ACA) is to expand insurance coverage, especially among households with lower incomes. The Congressional Budget Office (CBO) projects that about one-third of the additional insurance coverage expected to occur because of the law will come from expansion of the existing, unreformed Medicaid program. The rest of the coverage expansion will come from enrolling millions of people into subsidized insurance offerings on the ACA exchanges — offerings that have strong similarities to Medicaid insurance.

Unfortunately, ample evidence demonstrates that this kind of insurance model leaves the poor and lower-income households with inadequate access to health care. The networks of physicians and hospitals willing to serve large numbers of Medicaid patients have been very constrained for many years, meaning access problems will only worsen when more people enroll and begin using the same overburdened networks of clinics and physician practices.

It does not have to be this way. It is possible to expand insurance coverage for the poor and lower-income households without reliance on the flawed Medicaid insurance model. Opponents of the ACA should embrace plans to replace the current law with reforms that would give the poor real choices among a variety of competing insurance offerings, including the same insurance plans that middle-class families enroll in today. Specifically, we propose a three-part plan that includes a flexible, uniform tax credit for all those who lack employer-based coverage; deregulation of Medicaid; and improved safety-net primary and preventive care.

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The Supreme Court And The Contraception Mandate: A Temporary Setback For Contraception Coverage


June 30th, 2014

Editor’s note: See Health Affairs Blog for more coverage of the Supreme Court’s Hobby Lobby decision.

Today, the United States Supreme Court ruled that for-profit companies may avoid providing contraception coverage to employees if the companies sincerely object on religious grounds. At its narrowest interpretation, this decision is a significant but remediable setback for women’s reproductive health. At its broadest (but least likely interpretation), the decision has the potential to wreak havoc on public health regulation.

The legal challenges to the Affordable Care Act’s (ACA’s) contraception mandate have been well described in three previous Health Affairs Blog posts. To briefly recap, though, the ACA requires preventive services to be covered without copayments or other cost sharing in most employer-supported health plans. To implement this requirement, the Department of Health and Human Services (HHS) issued regulations that include all FDA-approved contraceptives, and a company that does not provide no-cost coverage of contraception is subject to substantial penalties.

Three groups of employers are exempt from the mandate: small businesses with less than 50 employees, purely religious employers, and “grandfathered” plans that have not changed meaningfully since the ACA was passed. Additionally, religiously affiliated non-profits (such as universities and hospitals) received a special accommodation from HHS by which women can receive contraception from third-party insurers at no extra cost to employees or the organization if the organization objects to covering contraception and identifies an alternate insurer.

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