From The Staff

Exhibit of the Month: Improving Pharmaceutical Innovation


February 27th, 2015

Editor’s note: This post is part of an ongoing “Exhibit of the Monthseries. Readers who’d like to highlight other noteworthy exhibits from the same issue are encouraged to make their pitch in the comments section below.

This month’s exhibits, published in the February issue of Health Affairs, illustrate annual new drug approvals by the Food and Drug Administration (FDA), industry spending on research and development, and more specifically, the number of drugs approved per $1 billion spent on research and development. Read the rest of this entry »

Health Affairs Web First: Assessing Health And Health Care Perceptions In sub-Saharan Africa


February 27th, 2015

A large share of Western aid to developing countries goes to sub-Saharan Africa, a region where spending on health care is around $100 per person in 2005 price-adjusted terms. This region, which experienced large gains in life expectancy in the years following World War II, suffered health-related setbacks in the closing years of the twentieth century as a result of the HIV/AIDS epidemic.

The authors of a February 25 Health Affairs Web First study used data from the Gallup Organization’s 2012 World Poll to investigate health and health care perceptions in sub-Saharan Africa compared to other regions of the world. The poll found that sub-Saharan Africans’ overall evaluation of their well-being was lower than that of any other population in the world. Additionally, only 42.4 percent of residents in that region were satisfied with the availability of high-quality health care in their community, also the lowest level in the world. Even so, when sub-Saharan Africans were asked to name the issues that should be the highest priorities for their government, health care was not seen as the most pressing issue. Read the rest of this entry »

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.

Read the rest of this entry »

The Latest Health Wonk Review


February 19th, 2015

Last week Peggy Salvatore posted a Valentine’s Day edition of the Health Wonk Review at the Health System Ed blog. Peggy includes Ron Pollack’s Health Affairs Blog “Contributing Voices” post arguing that both the text of the Affordable Care Act and congressional intent indicate that premium tax credits should be available in states using the Federally Facilitated Marketplace. Read the rest of this entry »

Health Affairs Web First: Recent US Hospital Productivity Growth


February 11th, 2015

Between 2002 and 2011, US hospitals increased their productivity in treating Medicare patients for several serious illnesses, refuting fears about a “cost disease” in health care and potentially mitigating concerns about provider payment under the Affordable Care Act.

The study, released today by Health Affairs as a Web First, addresses the quality of care and the severity of patient illness (considerations not fully taken into account by previous studies on this topic) found that during those years, the annual rates of productivity growth were 0.78 percent for heart attacks, 0.62 percent for heart failure, and 1.90 percent for pneumonia.

When the authors John Romley, Dana Goldman, and Neeraj Sood calculated productivity growth rates without factoring in trends in the severity of patient conditions or outcomes achieved after hospitalization, the annual productivity rates were different: -0.64 percent for heart attacks, -0.91 percent for heart failure, and -0.39 percent for pneumonia. Read the rest of this entry »

New Narrative Matters: How Access, Knowledge, And Attitudes Shaped My Sister’s Care


February 6th, 2015

Health Affairs‘ February Narrative Matters essay features a woman who helps her sister get the care she needs when a tooth infection turns into a health emergency. Elizabeth Piatt’s article is freely available to all readers, or you can listen to the podcast. Read the rest of this entry »

Request For Abstracts: Health Affairs Food And Health Theme Issue


February 4th, 2015

Health Affairs is planning a theme issue on food and health in November 2015. The issue will present work that explores the relationship between the food we consume and our wellbeing on the individual, societal, and global levels. Articles will address causes and consequences of dietary excess and insufficiency, analyze policies and programs aimed at influencing these, and explore the roles of public policy, industry, and stakeholder groups in the context of dietary behavior.

We invite all interested authors to submit abstracts for consideration for this issue.

The issue will consider the implications of global food production and distribution for the health of consumers and food workers, environmental quality, and food prices, among other things. It will also examine actions taken from the community level upward to address increasingly universal concerns about food-related illness. Several papers will provide broad overviews of key issues, but we are particularly interested in empirical analyses of specific policies, programs, and practices aimed at influencing dietary behavior and clarifying our thinking about food’s role in health. Read the rest of this entry »

Health Affairs Event Reminder: Biomedical Innovation


February 3rd, 2015

Biomedical innovation lengthens and enriches our lives through breakthroughs in medications and care, but it is has also been the leading source of health care cost growth over the past few decades. The February 2015 thematic issue of Health Affairs examines the topic from many perspectives.

You are invited to join us on Thursday, February 5, at a forum featuring authors from the new issue at the W Hotel in Washington, DC. Panels will cover pharmaceuticals; biotechnology; medical devices; and accelerating, diffusing, and financing innovation.

WHEN: 
Thursday, February 5, 2015
9:00 a.m. – 12:30 p.m.

WHERE: 
W Hotel Washington
515 15th Street NW
Washington, DC, Great Room, Lower Level

REGISTER NOW!

Follow live Tweets from the briefing @Health_Affairs, and join in the conversation with #HA_BiomedInnovation.

See the full agenda. Among the confirmed speakers are: Read the rest of this entry »

Health Affairs’ February Issue: Biomedical Innovation


February 2nd, 2015

The February issue of Health Affairs includes a number of studies examining issues pertaining to biomedical innovation. Some of the subjects covered: how declining economic returns for new drugs may affect future investments, the changing landscape of Medicare coverage determinations for medical interventions, the slowly emerging US biosimilar market, and more.

With declining economic returns, can manufacturers afford to continue investing?

Ernst Berndt of Massachusetts Institute of Technology’s Alfred P. Sloan School of Management and coauthors compared present values of average lifetime pharmaceutical revenues to present values of average drug research and development, and lifetime operating costs. Upon examining new prescription drugs launched over four distinct time periods between 1991 and 2009, the authors found that net economic returns reached a peak in the late 1990s and early 2000s. Read the rest of this entry »

The Latest Health Wonk Review


January 30th, 2015

On January 29, Jason Shafrin at Health Care Economist published a “Super Bowl” edition of the Health Wonk Review. Jason’s round-up contains no hot air, but it’s not at all deflating — it includes two Health Affairs Blog posts on the present and future of Medicare ACOs by Mark McClellan and coauthors and Scott Heiser and coauthors.

We also want to give a delayed shout-out to the nice “shake the winter blahs” Health Wonk Review that Vince Kuraitis published at e-CareManagement on January 15. Vince included a Health Affairs Blog post by Uwe Reinhardt reacting to Jonathan Gruber’s controversial remarks and explaining why Americans aren’t stupid but are often ignorant about policy issues. Read the rest of this entry »

Contributing Voices

Implementing Health Reform: Medicaid & CHIP Enrollment; Tax Forms; And SEP (March 30 Update, IPAB Challenge Dismissal)


March 22nd, 2015

Update, March 30: Dismissal of IPAB challenge.  On March 30, 2015, the curtain fell on another lawsuit challenging the Affordable Care Act when the Supreme Court denied certiorari in Coons v. Lew.    Coons had challenged the individual mandate on a number of bases, including that it violated his rights to medical privacy.  The Coons case has been best known, however, for its challenge to the constitutionality of the Independent Payment Advisory Board, or IPAB.

In August of 2014 the Ninth Circuit Court of Appeals affirmed a district court decision dismissing all claims in the case.  In particular, the Court dismissed the challenge to the IPAB, holding that any injury the IPAB might cause the plaintiffs if the IPAB is ever constituted is currently too remote and speculative to support jurisdiction in the court.  The plaintiffs requested Supreme Court review.  Today, the Court denied that request.  This does not, of course, foreclose a future challenge to a future IPAB, but does settle the issue at least until there actually is an IPAB.

Update March 27Agent and broker training.  The 2016 Benefit and Payment Parameters Final Rule  included new regulations for certifying vendors of federally facilitated marketplace broker and agent training.  CMS has now released an application form for vendors wishing to offer these training programs.  Issues covered by the form include training experience, training offered, information verification experience and programs, compliance history, data privacy and security protection, quality assurance, fee structure, and project staff.

Calculating premium tax credits.  I have just discovered IRS Publication 974, which apparently has been available since some time in February.  Publication 974 provides a comprehensive overview of the rules governing premium tax credits, including a number of examples and worksheets.  It is particularly useful for addressing complex issues like the calculation of premium tax credits when a couple get married mid-year, or the coordination of the self-employed health insurance deduction and premium tax credits.

The instructions for the IRS Form 8962 refer to Publication 974 for further guidance on a number of important questions not fully explored by the instructions.  At first glance, the publication seems to offer more comprehensive answers to these questions.

Update, March 24, Medicaid expansion and uncompensated care: On the fifth anniversary of the signing of the Affordable Care Act, the Assistant Secretary for Planning and Evaluation released two new reports documenting progress under the law.  The first report reviewed a number of studies that have estimated the impact of Medicaid expansion on increasing state gross domestic product, creating jobs, reducing uncompensated care, and improving the financial circumstances of poor people.  The second report specifically addresses reduction in uncompensated care. Read the rest of this entry »

Mortality Versus Survival In International Comparisons Of Cancer Care


March 20th, 2015

In a recent paper, Soneji and Yang revisit a topic we first explored in the April 2012 issue of Health Affairs — namely, whether the U.S. gets value for its cancer care. We found that life expectancy after cancer diagnosis rose more quickly for patients in the U.S. than for patients in Europe. Moreover, while spending per patient also rose more quickly in the U.S., Americans still received good value from the health care system. Compared to the gains seen in Europe, for example, each additional life-year gained in the U.S. cost roughly $20,000 in additional U.S. spending.

Soneji and Yang re-examine trends in cancer deaths in the U.S. and Europe and draw different conclusions. While we welcome the attention paid to this important issue, Soneji and Yang’s conclusions rest on fundamental flaws in their own approach and a misunderstanding of the methods we use in our study.

To understand the value of U.S. cancer care, one must ask whether the health care system performs better for U.S. cancer patients than those of other countries and at what cost. In attempting to answer this question, Soneji and Yang ask whether more people die from cancer in the U.S. or in Europe. This isn’t the right question. The total number of people dying from cancer is a misleading indicator of health system performance. Factors like poverty, pollution, smoking, diet, and exercise all contribute to the number of people acquiring cancer and dying from it, and confound the effects of cancer treatments. The bottom line is that mortality reflects treatment, but it also reflects the number of people who get cancer. Read the rest of this entry »

Narrative Matters: On Our Reading List


March 20th, 2015

Welcome to “Narrative Matters: On Our Reading List,” a monthly roundup where we share some of the most compelling health care narratives driving the news and conversation in recent weeks.

End Of A Life

In a moving first-person essay in The New York Times, writer and neurologist Oliver Sacks details his diagnosis of terminal cancer and his adjusted outlook toward his remaining time.

“I shall no longer pay any attention to politics or arguments about global warming,” he writes in “Oliver Sacks on Learning He Has Terminal Cancer.” “These are no longer my business; they belong to the future.”

Sacks’ works include The Man Who Mistook His Wife for a Hat, which described various neurological conditions and introduced the world to Temple Grandin, a woman with autism who is a bestselling author, autism activist, and professor of animal science. Read the rest of this entry »

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: Read the rest of this entry »

When It Comes To The Value Of Wellness, Ask About Fairness Not Just About Effectiveness


March 18th, 2015

After a short truce, the wellness wars are raging again on this blog, with some voices hailing workplace wellness programs as cost-effective means to better public health and others questioning their value.

Our own data show that both have a point. We have found that program participation is associated with statistically significant improvements in biometric markers, like BMI, and health-related behavior, like smoking and exercise. But we also find that those changes are not large enough, and the relationship between health risks and spending too weak, to result in reduction of health care cost, let alone in return of investment. Read the rest of this entry »

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).

Read the rest of this entry »

Implementing Health Reform: Wraparound Benefits Final Rule; Coverage Report (Revised)


March 17th, 2015

Correction: My March 17 post on the wraparound coverage rule (below) was based on a misunderstanding of how the Multi-State Plan program wrap works.  In fact, employer coverage would not wrap around MSP SHOP coverage but rather around individual MSP coverage.  Under prior guidance the employer would still not be able to pay for the primary individual MSP coverage, but would only pay for the wrap.

The employer could offer some categories of employees comprehensive coverage and other categories of employees only wrap coverage, as long as coverage offers did not discriminate on the basis of preexisting conditions or health status or in favor of highly compensated employees.  Alternatively, the employer might offer all emloyees the option of either comprehensive coverage or wrap coverage, in which case employees who opted for wrap coverage would not qualify for premium tax credits unless employer coverage was in fact inadequate or unaffordable.

Employers would in any event be required to continue to make a total aggregate contribution toward primary and wrap coverage for all employees that was “substantially the same” as the amount contributed for coverage of all full-time employees for plan years that began in 2013 and 2014.  The employer could be liable for the employer mandate penalty if the employer failed to offer adequate and affordable coverage to some employees that resulted in those employees receiving premium tax credits through the marketplace.

With open enrollment closed for 2015 and the Departments having finalized the Benefit and Payment Parameters Rule and Letter to Issuers for 2016, we have entered the Spring Affordable Care Act regulatory doldrums.  Reports, minor regulations, guidances, and court decisions continue to appear, however.  Two appeared on March 16.  This post addresses the final wraparound coverage excepted benefits rule, and a report on health insurance coverage and the ACA (technical appendix here), both released on March 16, 2015.

The wraparound coverage rule creates a new category of excepted benefits.  The concept of excepted benefits was created by the Health Insurance Portability and Accountability Act of 1996 and is carried forward in the ACA.  Excepted benefits plans provide benefits that resemble in some way the health benefits that have been regulated by HIPAA and are now regulated by the ACA, but are more limited or are more tangential to medical care.  These include benefits that are not generally medical benefits but do afford some medical coverage (auto liability, workers’ compensation); health coverage that is not medical coverage (dental, vision, long-term care); benefits that are not coordinated with medical benefits (specific disease coverage, fixed dollar indemnity coverage); and coverage that is supplemental to medical coverage (such as Medicare supplement policies).  Additional specific conditions must be met for some of these benefits to qualify as excepted benefits.

Excepted benefits are generally not subject to Affordable Care Act requirements, such as the ban on dollar coverage limits or preexisting conditions clauses.  But excepted benefit coverage explicitly does not qualify as minimum essential coverage.  An individual who has only excepted benefit coverage and does not qualify for a shared responsibility requirement exception must still pay the individual mandate penalty.  Large employers that offer only excepted benefits may have to pay the employer responsibility penalty, but individuals offered only excepted benefits by their employers are not disqualified from receiving premium tax credits to purchase individual coverage through the marketplaces. Read the rest of this entry »

Can Safety-Net Hospital Systems Redesign Themselves To Achieve Financial Viability?


March 16th, 2015

Safety-net hospital systems have long played a special role in the nation’s health care system by serving low-income, medically, and socially vulnerable patients regardless of their ability to pay. Beyond caring for people regardless of insurance coverage, safety-net systems provide comprehensive care to meet the needs of their diverse, complex patient populations, including culturally-responsive health and social services that other hospital systems do not.

As providers of last resort, some safety-net systems, especially public hospitals, are expected by their communities and by state and local governments to offer needed but unprofitable services, regardless of whether adequate revenue streams exist to support these services.

In recognition of that role, national, state, and local government agencies historically have provided supplemental funding to these systems to offset unreimbursed and under-reimbursed care. Under the Affordable Care Act, however, that is changing. With the expectation that most people will be insured under the new law, policy makers have planned to reduce much of this supplemental funding. In this view, safety-net systems will either become financially independent or close. Read the rest of this entry »

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.) Read the rest of this entry »

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? Read the rest of this entry »

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