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Sovaldi, Harvoni, And Why It’s Different This Time


November 21st, 2014

With the Food and Drug Administration (FDA)’s approval of Harvoni, the successor to Gilead Science’s Sovaldi, the alarm bells have officially rung on breakthrough hepatitis C treatments. One can’t open a newspaper or scan a Twitter feed without stumbling on at least one reference to either of the these two drugs for hepatitis C — an often debilitating viral infection impacting the liver that affects somewhere between 3 to 5 million Americans and several hundred million people worldwide. Hepatitis C infection is often asymptomatic and can have long latency periods. In up to 20 percent of people, chronic infection can lead to liver failure, liver cancer, and potentially liver transplantation.

Gilead Sciences paid $11 billion to acquire the rights to Sovaldi — a drug that offers significant improvement in viral clearance over existing therapies — and launched the drug in the U.S. market at a price ($1,000 per pill, or $84,000 per course of treatment) that is usually reserved for drugs targeting “orphan conditions” for much smaller populations. Not surprisingly, Congress has taken an interest, patient advocacy groups are organizing, the health care community is holding conferences, coalitions are channeling a growing national outrage about the price, and public and private payers are stymied by the challenge of responsibly managing utilization of the drug.

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Adverse Events In Older Adults: The Need For Better Long-Term Care Financing And Delivery Innovation


November 20th, 2014

Evidence mounts that a major disconnect exists between the services most frail older adults need and what they get. The vast majority of frail older adults (around 75 percent) who face challenges in taking care of themselves live at home. According to new research from Vicki Freedman and Brenda Stillman, published in the most recent issue of The Milbank Quarterly, almost a third of these older adults report having an adverse consequence as a result of not getting the help they need. These consequences are pretty grim – the most frequently reported event being wet clothes associated with an unmet need around toileting.

But the most shocking statistic from this research is that hiring a paid helper appears to do little to protect against these consequences. Among those who hired help, nearly 60 percent reported adverse consequences. No doubt this reflects a higher level of need: paid helpers are brought in when the risk is quite high. But, it also reflects an inadequacy in support — an analogous group living in supportive housing (i.e., residential care or assisted living facilities) reported these events at a much lower rate (36 percent).

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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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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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Analysis Of Medicare Spending Slowdown Leads Health Affairs Blog October Most-Read List


November 17th, 2014

Loren Adler and Adam Rosenberg’s examination of the causes of slower Medicare spending growth was the most-read Health Affairs Blog post in October. Their post was followed by Jeff Goldsmith’s interview with former Kaiser Permanente CEO George Halvorson.

Next on the top-ten list was J. Stephen Morrison’s look at the US response to Ebola and the role of Centers for Disease Control and Prevention Director Tom Frieden, followed by Tim Jost’s post on reference pricing and network adequacy.

The full list is below:

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The Short-Term And Long-Term Outlook Of Drug Coupons


November 12th, 2014

In the October 2014 Health Affairs article, “Specialty Drug Coupons Lower Out-Of-Pocket Costs And May Improve Adherence At The Risk Of Increasing Premiums,” Catherine Starner and coauthors explore the relationship between drug coupons and specialty drugs. Specialty drugs, primarily injectables and biologics, are costly drugs used to treat complicated, chronic conditions that typically require special handling, administration, and monitoring. Starner et al. report that specialty drugs have an average monthly cost to patients and payers of about $3,500.

In their innovative study, Starner et al. find that nearly half of the patients in their sample who were prescribed specialty drugs used personal drug coupons to reduce their personal financial responsibilities. Coupons come in the form of maximum copay and monthly savings cards, and can be accessed from the brand-name manufacturer’s website, printed out, and cashed in at the pharmacy.

Manufacturers promote drug coupons as supplementary patient assistance programs that can fill gaps in insurance coverage by reducing individual patients’ responsibilities for out-of-pocket health care costs related to high-cost specialty drugs or other pharmaceutical products. For example, patients taking etanercept (Enbrel), an expensive biologic specialty drug indicated for rheumatoid arthritis, can receive savings via the Enbrel Support plan, which reduces the monthly co-pay to $0 for the first six months and $10 per month thereafter.

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Tax Filing And The ACA: Helping Americans Meet The Challenge


November 7th, 2014

Tim Jost’s post of September 21, 2014 expressed concern about the problems that Americans who are uninsured or who have received or qualify for premium tax credits will face in filing their taxes for 2014.  Those who are not otherwise insured and who wish to claim an exemption from the shared responsibility penalty will have to file tax form 8965.  Those who received advance premium tax credits during 2014 will have to file a form 8962, as will those who did not receive advance premium tax credits but who wish to claim premium tax credits on their tax return.  Tax filers who fail to reconcile their tax credits for 2014 cannot claim tax credits for subsequent years.

Individuals who did not have coverage at the beginning of 2014, but purchased coverage at some point in the year through the marketplaces, may need to file both forms.  For example, victims of domestic violence or spousal abandonment were granted a special enrollment period part of the way through 2014 and will have to file an 8965 for the months they were uninsured before they enrolled and an 8962 for months after they enrolled.

This post offers suggestions as to how the Internal Revenue Service and Centers for Medicare and Medicaid Services, the two agencies that oversee the shared responsibility and premium tax credit programs, might mitigate the problems that tax filers may face in filing their taxes for 2014.

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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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An Emerging Consensus: Medicare Advantage Is Working And Can Deliver Meaningful Reform


November 6th, 2014

Since enactment of the Affordable Care Act (ACA) in 2010, much of the attention in the policy community has been on modernizing Medicare’s traditional fee-for-service (FFS) program.  Through Accountable Care Organizations (ACOs), larger “bundles” of payments to fee-for-service providers for episodes of care, and tests of pay-for-performance models, the hope is that the traditional Medicare model can be remade through sheer force of bureaucratic will.  The stated intent is to find a way to pay for value, not volume.

These efforts may or may not bear much fruit, but, over the longer term, it’s not likely to matter much.  That’s because a more important transformation of Medicare is already well underway and is occurring despite more resistance than assistance from the program’s bureaucracy.  According to the 2014 Medicare Trustees’ report, enrollment in Medicare Advantage – the private plan option in Medicare — has been surging for a decade.  In 2005 there were 5.8 million Medicare beneficiaries enrolled in MA plans — 13.6 percent of total enrollment in the program.  Today, there are 16.2 million beneficiaries in MA plans, or 30 percent of program enrollment. (See Table IV.C1)  In addition, the Medicare drug benefit, which constitutes about 12 percent of total program spending, is delivered entirely through private plans. (See Table II.B1)

As MA enrollment has surged, so has recognition of its improved value.  A recent, comprehensive review of the evidence conducted by Joseph Newhouse and Thomas McGuire of Harvard University makes a compelling case that MA plans are providing higher value services at less societal cost than the traditional FFS program.  Based on their findings, Newhouse and McGuire argue for policies that would provide incentives for even more beneficiaries to enroll in MA plans in the future.

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The Payment Reform Landscape: Benefit And Network Design Strategies To Complement Payment Reform


November 4th, 2014

For the past ten months on Health Affairs Blog, we’ve been discussing the evidence for different models of payment reform, examining everything from pay for performance to nonpayment. But no discussion of payment reform is complete without addressing benefit and network designs and how they can help or hinder various payment reforms.  When the right payment method is paired with the right benefit and/or network design, they can work together to help reduce costs and improve care.  There are a number of payment approaches that pair well with specific benefit and network design strategies to yield higher-quality, lower-cost care. Below we discuss a few of these effective pairings.

But before we get into the specifics, why it is important to motivate providers to deliver and patients to seek higher-value care?  Health care providers may not only respond to direct financial incentives, but they are also likely to respond to knowing information about their performance is being put in front of prospective and current patients.  They also may be more willing to accept new forms of payment if acceptance means payers will encourage more patients to seek their care.

On the flip side, patients are unlikely to know how their providers are paid.  But if motivated (financially and otherwise), patients may act on meaningful distinctions in price and quality by choosing higher-value providers, saving money for themselves and whoever else is footing the bill for their care.

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Grand-Aides And Health Policy: Reducing Readmissions Cost-Effectively


October 29th, 2014

Hospital readmissions for the same condition within 30 days likely should not occur, and most often indicate system failure. Readmitted patients are either discharged too early, should be placed into palliative care or hospice, or most often are victims of a failure in transition of care from hospital to home. Most hospitals and physicians would like to eliminate such readmissions, particularly now that payers like Medicare are penalizing hospitals for high rates of readmission. Numerous approaches have been tried to reduce readmissions, with recent published improvements between a 2 percent and 26 percent reduction.

The Grand-Aides® program features rigorous training of nurse aides or community health workers to work as nurse extenders, 5 Grand-Aides to one RN or NP supervisor, with approximately 50 patients per Grand-Aide per year. The Grand-Aides visit at home daily for the first 5 days post-discharge and then as ordered by the supervisor (e.g. 3 days the next week) for at least 30 days, extending as long as desired.

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Exhibit Of The Month: Comparing The Cost And Value Of Specialty And Traditional Drugs


October 27th, 2014

Editor’s note: This post is part of an ongoing “Exhibit of the Month” series. 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, from the article, “Despite High Costs, Specialty Drugs May Offer Value For Money Comparable To That Of Traditional Drugs,” published in the October issue of Health Affairs, compare the value and costs of specialty and traditional drugs approved by the Food and Drug Administration from 1999-2011.

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Adult Conversation On High-Priced Drugs? Don’t Hold Your Breath (But Hang In There) …


October 27th, 2014

The benevolent identity of the health care enterprise tends to moderate disagreements and keep them under a big tent of shared goals. In the case of very high prices for powerful new drugs, however, the commons gets stretched painfully thin. Drug companies which see themselves as pioneers are accused of being merely greedy. Cost-conscious payers and regulators are impugned for depriving patients of life-conserving treatment breakthroughs. A divisive political undercurrent often threatens to obtrude. Altogether, a tough environment for rational policy assessment.

Credit is due, accordingly, to the Brookings Institution, for putting a wide array of views on display at its October 1 forum on “the cost and value of biomedical innovation,” which was jointly sponsored by the Schaeffer Center at the University of Southern California. With the head of Gilead Sciences at one pole of the discussion and a leading generics industry attorney at the other, the discussion didn’t lack for strongly-held views, strongly stated.

But the tone was civil, a lot of useful information was exchanged, and the audience went away carrying a meta-message about the importance of maintaining an “adult conversation” on a subject of such obvious importance and difficulty.

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Will Employers Favor Private Exchanges Over Coverage Sponsorship?


October 17th, 2014

Over the past couple years, health care exchanges probably have consumed more of corporate benefits managers’ time and psychic energy than any other topic. An outstanding question is whether the rank and file of American businesses will drop the hassle that employer-sponsored coverage represents, or default to private exchanges.

Private exchange offerings typically move employees from their companies’ previous self-funded health plans to fully-insured individual arrangements, purporting to offer more flexibility and choice that can adapt to the wide-ranging needs of employees and employers, while creating a more competitive health plan marketplace.

Several recent surveys have reported that employers plan to move aggressively to private exchanges. In a survey last year of more than 700 businesses, the Private Exchange Evaluation Collaborative, a group of regional business health coalitions working with the consulting group PwC, found that 45 percent of employers have implemented or are considering using a private exchange for active employees before 2018. Similarly, a February Aon Plc survey found that, while 95 percent of employers say they expect to continue offering health care for the next 3-5 years, and 5 percent of employers currently use a private exchange, 33 percent say they may consider using one in the future.

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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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Slow Health Care Spending Growth Moderates GDP Growth In The Short Term And Policy Targets Should Reflect This


October 16th, 2014

Economic growth is most often measured by growth in gross domestic product (GDP), which is the value of all final goods and services produced in an economy. Recent revisions to the first quarter 2014 estimates of U.S. GDP growth have raised concerns over the extent to which the Affordable Care Act (ACA) might be impacting economic growth.

The Bureau of Economic Analysis (BEA) first estimated GDP growth for the first quarter of 2014 to be 0.1 percent on an annualized basis. Then a revised second estimate was made, which indicated a decline in GDP of 1.0 percent on an annualized basis. Finally, on June 25 a second and final revised estimate of a 2.9 percent decrease on an annualized basis was released.

While revisions to initial estimates of GDP growth are not uncommon, one aspect of this second revision was, indeed, uncommon. Nearly two-thirds of the second downward revision (1.2 of the 1.9 percent) was attributed to health care spending being substantially lower in the first quarter of 2014 than was originally forecasted by the BEA.

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Implementing Health Reform: Reference Pricing And Network Adequacy


October 12th, 2014

On October 10, 2014, the Departments of Labor, Treasury, and Health and Human Services issued a frequently asked question (FAQ) regarding the use of reference-based pricing in non-grandfathered large group employer plans.  Although the issue the FAQ addresses specifically is the use of reference pricing, the FAQ is remarkable insofar as it is the first departmental guidance that I am aware of that addresses the use of networks by self-insured ERISA plans.

Network adequacy is an issue that has long been addressed in the nongroup and insured group market in many states by state insurance law.  The ACA also requires qualified health plans, and arguably any individual and small group plan subject to the essential health benefits requirements, to have adequate provider networks.  Special rules implementing ACA section 2719A of the ACA limit cost-sharing for out-of-network coverage for emergency services.

The departments also stated in an earlier FAQ that cost sharing cannot be applied by any non-grandfathered health plan for preventive services provided by out-of-network providers if the services are not available in network.   But I am unaware of the departments otherwise attempting previously to regulate group health plan network requirements, at least under the ACA.

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The Need For A Comprehensive, Current, And Market-Representative Health Care Cost Benchmark


October 7th, 2014

A recent post from Jonathan Skinner and colleagues on Health Affairs Blog posited an interesting solution to ever-increasing health care costs, suggesting that imposing price caps on all medical services, equal to 125 percent of the Medicare payment, would serve to eliminate wide variations in quoted prices for health care services.

While the overall idea of controlling costs through the establishment of a mutually agreed-upon and accessible benchmark is a sound one, the use of Medicare reimbursement levels as a ceiling for this purpose would present a number of challenges. For example, Medicare does not assign a value to all codes; a separate system would be needed to price services not addressed by Medicare’s fee schedule.

Also, Medicare’s reimbursement levels can be influenced by governmental imperatives and therefore may not be truly representative of market costs. And the establishment of a 125 percent of Medicare cap—a standard used by some health plans for in-network care where providers are guaranteed a high volume of patients—might not be adequate reimbursement for one-off, out-of-network services that lack a network’s compensatory volume economics.

We at FAIR Health suggest an alternative approach using measures that are acceptable to all stakeholders as reference points for out-of network charges to help achieve the proposal’s laudable goal: to provide quality health care at transparent prices that are reasonable for consumers and fair to providers.

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Health Affairs October Issue: Specialty Drugs — Cost, Impact, And Value


October 6th, 2014

The October issue of Health Affairs, released today, includes a number of studies looking at the high costs associated with today’s increasingly prevalent specialty drugs. Other subjects covered in the issue: an assessment of whether some hospitals may be taking advantage of the 340B drug discount program; a review of how shortened residency shifts impact patient care; a study on the increasing costs associated with Hepatitis C and advanced liver disease; and more.

The new issue will be discussed at a Washington DC briefing tomorrow. This issue of Health Affairs was supported by CVS Health.

Do specialty drugs offer value that offsets their high costs?

James Chambers of Tufts Medical Center and coauthors conducted a cost-value review of specialty versus traditional drugs by analyzing incremental health gains associated with each. This first-of-its-kind analysis is timely because the majority of drugs now approved by the Food and Drug Administration are specialty drugs produced using advanced biotechnology and requiring special administration, monitoring, and handling — all of which result in higher costs.

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Reminder: Health Affairs Briefing: Specialty Pharmaceuticals


October 3rd, 2014

We live in an era of specialty pharmaceuticals — drugs typically used to treat chronic, serious or life threatening conditions such as cancer, rheumatoid arthritis, growth hormone deficiency, and multiple sclerosis.  Their cost is often much higher than traditional drugs, and they are set to account for more than half of all drug spending by the end of this decade.

The October 2014 edition of Health Affairs, “Specialty Pharmaceutical Spending and Policy,” contains a cluster of articles examining the host of issues related to specialty pharmaceuticals: from the promise they hold for curing or managing chronic diseases, to the risk they pose for exacerbating health care costs and disparities, and the challenges they present for policymakers striving to balance both.

Please join us on Tuesday, October 7, for a briefing on the October issue moderated by Health Affairs Editor-in-Chief Alan Weil.

WHEN: 
Tuesday, October 7, 2014
9:00 a.m. – 11:30 a.m.

WHERE: 
Hyatt Regency Capitol Hill
400 New Jersey Avenue, NW
Washington, DC, Lower Level

REGISTER NOW!

Follow Live Tweets from the briefing @Health_Affairs, and join in the conversation with #HA_SpecialtyDrugs.

Health Affairs is grateful to CVS Health for its financial support of the issue and event.

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