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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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Health Affairs Web First: In 11-Country Survey Of Older Adults, Americans Are Sickest But Have Quickest Access To Specialists


November 20th, 2014

A new survey of the health and care experiences of older adults in eleven different countries, released recently as a Web First by Health Affairs, found that Americans were sicker than their counterparts abroad, with 68 percent of respondents living with two or more chronic conditions and 53 percent taking four or more medications. Also, Americans were most likely to report cost-related expenses for care (19 percent of respondents) than residents in any of the other countries surveyed.

On the other hand, the United States compared favorably in some aspects: For example, 83 percent of US respondents had a treatment plan they could carry out in their daily life, one of the highest rates across the surveyed countries.

A few other key findings:

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The Case For Advancing Access To Health Coverage And Care For Immigrant Women And Families


November 19th, 2014

Before the end of the year, the Obama administration is expected to announce that millions of undocumented immigrants will be able to lawfully stay in the United States. The new Congress may also take action on immigration reform legislation. Regardless of how it happens, any immigration policy change presents a good opportunity to revisit what has gone wrong with insurance coverage and health care for millions of immigrants, both undocumented and lawfully present, living and working in communities across the country.

A web of policy barriers to public and private insurance options effectively keeps millions of immigrant women and their families from affordable coverage and the basic health care—including sexual and reproductive health services—that coverage makes possible. Removing these barriers would advance the health and economic well-being of immigrant women, their families, and society as a whole. Most immediately, administrative steps advancing access for even some immigrants would be an important step forward. The case for doing so is compelling.

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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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New Health Policy Brief: The Family Glitch


November 10th, 2014

A new health policy brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) looks at the Affordable Care Act’s (ACA’s) so-called family glitch. Low-to-moderate-income families are eligible for a subsidy to purchase health insurance on the Marketplace if the cost of health coverage through their employers is more than 9.5 percent of their household income.

However, this formula is based on individual-only coverage and does not account for the higher cost of a family insurance plan. If the family glitch is not fixed, the path to affordable insurance for many spouses and children could be blocked—and children could be even further impacted if Congress fails to extend funding for the Children’s Health Insurance Program (CHIP) after the current appropriation ends in September 2015, which the brief also explains.

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Health Insurance Without An Annual Expiration Date? A Case For Exchange-Based Long-Term Policies


November 10th, 2014

Today, consumers make decisions every year about whether to renew or change health plans. Exchange-based multi-year plans would have to overcome significant obstacles before they become reality, but they hold the potential for helping the United States move toward goals of a healthier society and a more efficient health care system.

Since the launch of the federal and state health insurance exchanges in October 2013, set up to facilitate the purchase of insurance in line with the Affordable Care Act (ACA), millions of Americans have obtained coverage. In addition, several large employers, such as Sears and Walgreens, have announced that they will stop offering coverage and instead provide a defined contribution for their employees to purchase coverage on an exchange.

The growing role of exchanges, their price transparency, and the increasing share of the cost of coverage borne by enrollees is likely to make consumers pay increased attention to price. Price-sensitive buyers could encourage competition and thus efficiency. But there might be unintended consequences. Consumers might deliberately choose low-cost plans with limited benefits when they are healthy, knowing that the ACA allows them to purchase a more generous plan should they develop a chronic disease. The possibility of changing health plans when becoming sick might exacerbate the self-selection problem in the insurance market because the public exchanges allow only limited risk adjustment based on such factors as age, family composition, rating area, and tobacco use.

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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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Health Affairs Web First: New Study Shows Low-Income Residents In Three States Support Medicaid Expansion


October 9th, 2014

Expansion of Medicaid under the Affordable Care Act (ACA) to millions of low-income adults has been controversial. However, little is known what these Americans themselves think about Medicaid. A new study, recently released as a Web First by Health Affairs, surveyed nearly 3,000 low-income adults in Arkansas, Kentucky, and Texas (states that have adopted different approaches for Medicaid expansion).

This telephone survey, conducted in late 2013, found that 83 percent of respondents in Arkansas and Kentucky and 79 percent of those in Texas were in favor of their state expanding Medicaid under the ACA. Roughly two-thirds of uninsured respondents planned to apply for coverage in 2014. The majority of adults surveyed viewed Medicaid as comparable to or better than private insurance in overall health care quality.

Authors Arnold Epstein, Benjamin Sommers, Yelena Kuznetsov, and Robert Blendon developed a thirty-eight-item survey and targeted citizens ages 19–64 with household incomes of less than 138 percent of the federal poverty level. Forty percent of Texas respondents were Latino. A significant number of respondents (40 percent in Arkansas and Kentucky and 32 percent in Texas) said they were in “fair” or “poor” health, with a substantial number of respondents reporting living with chronic health conditions.

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Vets Deserve The Right To Shop For Care


October 2nd, 2014

Editor’s note: For more on this topic, see the Health Affairs Blog post from Theodore Stefos and James Burgess, and stay tuned for an upcoming blog post from Joel Kupersmith. 

As former Procter & Gamble CEO Robert McDonald steps in to lead the Department of Veterans Affairs (VA), it’s difficult not to think about the thousands of physicians across the U.S. who are chomping at the bit to contribute to the fix. Even before his recently confirmed appointment, McDonald said his focus would be on getting veterans the benefits and care they deserve. This customer-focused approach and his appointment in general have been greeted with rare bipartisan praise and unanimous passing. However, as the saying goes, the devil is in the details.

According to reports, tens of thousands of veterans have been waiting three months or longer for an initial appointment. Three months? Data from athenahealth’s national, cloud-based network of more than 55,000 health providers representing approximately 57 million patient records, recently found that the median wait time for a primary care visit for a new patient last year was about three days; non-well-visit wait times averaged around one day.

The point is that veterans have been waiting far longer for appointments than the general population at a time when the health care provider ecosystem – whether hospital or practice – outside the VA often struggles to fill beds and open slots. Seemingly, there are providers nationwide who would be eager to care for these vets and benefit from their business. For new VA Secretary Robert McDonald, a renowned consumer-goods leader, this supply and demand scenario nearly solves itself.

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Reference Pricing And Network Adequacy Standards: Conflict Or Concord?


September 18th, 2014

With benefit designs and enrollee cost-sharing increasingly standardized across health plans under the Affordable Care Act (ACA), one of the remaining levers plans have to differentiate themselves—and to control premiums—is the size of their provider networks. Regulators have been caught in a crossfire between advocates of narrow networks who say they promote quality and keep prices down, and those who feel narrow networks could constrain access to necessary services.

Unfortunately, recent federal guidance – addressing, among other related items, the issue of “reference pricing” — blurs the distinction between in-network and out-of-network providers and may make it more difficult for regulators and consumers to understand the effective “size” of a particular network.

This confusion could undermine the goal of improving transparency in consumers’ health care choices and make it difficult for consumers to use prices in choosing providers. More troubling, expanded use of “reference pricing” under the guidance could leave patients paying unexpectedly large out-of-pocket amounts for services provided by ostensibly in-network providers.

Below, we characterize reference pricing as a “sub-network” contracting strategy, and we describe some of the implications of reference pricing and the guidance for consumers, regulators, plans, and providers.

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Same Care No Matter Where She Gives Birth: Addressing Variation In Obstetric Care Through Standardization


September 12th, 2014

In August, Health Affairs published a study highlighting an alarming fact in maternal health: The incidence of childbirth complications varies significantly from hospital to hospital across the United States. The study – led by Laurent Glance and colleagues at the University of Rochester – found that “women delivering vaginally at a low-performing hospital had twice the rate of any major complications than women delivering vaginally at a high-performing hospital.” The difference in these complication rates for cesareans was five-fold.

It is well known that variation in care contributes to higher rates of mortality and morbidity in all areas of health care, explaining the push toward checklists and other quality improvement tools and interdisciplinary collaboration. Identifying the primary reasons for variation in obstetric complication rates – why women giving birth in high-performing hospitals have lower complications rates – could be critical to understanding the reasons behind the increasing rates of maternal mortality and morbidity in the U.S. This study, along with other disturbing statistics, underscores the significant need for improvements in maternity care.

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Birth Control Pills Should Be Available Over The Counter, But That’s No Substitute For Contraceptive Coverage


September 10th, 2014

In recent weeks, some opponents of the Affordable Care Act’s (ACA) contraceptive coverage guarantee have promoted the idea that oral contraceptive pills should be available to adult women without a prescription. Sens. Kelly Ayotte (R-NH) and Mitch McConnell (R-KY), for example, recently introduced the so-called Preserving Religious Freedom and a Woman’s Access to Contraception Act, a bill that would urge the Food and Drug Administration (FDA) to study whether to make contraceptives over the counter (OTC) — though for adults only.

Making birth control pills available over the counter, if done right, would meaningfully improve access for some groups of women. However, such a change is no substitute for public and private insurance coverage of contraceptives — let alone justification for rolling back coverage of all contraceptive methods and related services for the millions of women who currently have it.

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Improving Access To High Quality Hospice Care: What Is The Optimal Path?


September 9th, 2014

Editor’s note: This post is part of a periodic Health Affairs Blog series on palliative care, health policy, and health reform. The series features essays adapted from and drawing on an upcoming volume, Meeting the Needs of Older Adults with Serious Illness: Challenges and Opportunities in the Age of Health Care Reform, in which clinicians, researchers and policy leaders address 16 key areas where real-world policy options to improve access to quality palliative care could have a substantial role in improving value.

High quality hospice care is consistent with the country’s stated health care reform goals: hospice is person-centered, improves clinical outcomes such as pain and satisfaction, is provided by a multidisciplinary care team, is coordinated across care settings, reduces unnecessary hospitalizations, and saves health care dollars. Studies have consistently shown that hospice improves quality for patients and families by reducing symptom distress, improving caregiver outcomes, and reducing hospitalizations near the end of life, including emergency department visits and intensive care unit stays and hospital death.

But what about access? Fortunately, hospice care in the United States is growing rapidly and there is much to celebrate in terms of the increase in the number of hospice agencies, the number of patients and families served by hospice, and the breadth of conditions and diagnoses of patients receiving hospice care. In 2011 there were more than 3,500 hospice providers — an increase of 53 percent from 2000 — caring for 1.2 million Medicare beneficiaries.

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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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Rescue Me: The Challenge Of Compassionate Use In The Social Media Era


August 27th, 2014

The Development of Brincidofovir and its Possible Use to Treat Josh Hardy

Last March 4, seven-year old Josh Hardy lay critically ill in the intensive care unit at St Jude Children’s Hospital in Memphis, Tennessee with a life-threatening adenovirus infection. His weakened immune system was unable to control the infection, a complication of a bone marrow stem cell transplant he needed as a result of treatments for several different cancers since he was 9 months old.

His physicians tried to treat the adenovirus with an anti-viral agent, Vistide (IV cidofovir), but had to stop due to dialysis-dependent renal failure. They were aware of another anti-viral in Phase 3 clinical development, brincidofovir, an oral compound chemically related to Vistide. In earlier clinical testing brincidofovir had shown the potential for enhanced antiviral potency and a more favorable safety profile.

Chimerix (where one of us, Moch, was CEO), a 55 person North Carolina-based biopharmaceutical company, had previously made brincidofovir available to more than 430 critically ill patients in an expanded access program for the treatment of serious or life-threatening DNA viral infections, including adenovirus as well as herpes viruses (such as cytomegalovirus) and polyomaviruses.  This program started in 2009 as a series of individual physician-sponsored emergency INDs — investigational new drug exemptions issued in physician-certified compassionate use situations.

The program evolved via word of mouth to the extent that brincidofovir was made available under emergency INDs for more than 215 patients. During 2011, Chimerix received funding from Health and Human Service’s Biomedical Advanced Research and Development Authority (BARDA) to provide brincidofovir to an additional 215 critically ill patients for the purpose of gaining insights into the potential use of brincidofovir as a medical countermeasure against smallpox. (Department of Health and Human Services Contract No. HHSO100201100013C.  For further information on brincidofovir Study CMX001-350, see ClinicalTrials.gov Identifier NCT01143181.)

When BARDA funding ended in 2012, Chimerix stopped accepting new requests for compassionate use under its expanded access program. Although requests continued from physicians around the world, the company decided that it was in the best interests of the greatest number of patients to devote its limited human and financial resources to the clinical development pathway necessary for FDA approval of brincidofovir.

This post examines the implications of the ultimately successful campaign waged by Josh Hardy’s family to obtain access to brincidofovir for their son. We discuss several issues raised by the Hardy case, including the overarching question of whether it is fair for social media or influence of any form to play a role in determining which patients get access to experimental treatments; whether rescuing individual patients in need can be reconciled with an evidence-based regulatory approval process for new therapies; and whether there is a duty to “rescue” terminally ill patients by paying for access to experimental therapies.

Finally, we propose a new framework for regulating access to experimental treatments.

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It’s Hard To Be Neutral About Network Neutrality For Health


August 18th, 2014

Network Neutrality (NN) has been in the news because the FCC is considering two options related to a neutral Internet: Either regulation forcing NN, or an approach that creates a “fast lane” on the Internet for those content providers that are willing to pay extra for it.

Network Neutrality reflects a vision of a network in which users are able to exchange and consume data, as they choose, without the interference of the organization providing the network basic data transport services. The second option, preferential service, entertains the possibility that the Internet could become what the National Journal describes as “a dystopia run by the world’s biggest, richest companies.”

However, the problem of network neutrality is more complex. Full network neutrality could also lead to a tragedy of the commons in which application developers compete for the use of “free” bandwidth for services to win customers while clogging networks and lowering performance for all. Key stakeholders providing basic transport Internet service such as Comcast, Verizon, or AT&T, and large Internet savvy content providers like Google have a clear understanding of the debate and what they stand to gain or lose from network neutrality.

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Mental Health Reform: Treating Before Stage 4


August 11th, 2014

When I talk about mental illnesses, I often point out that as a matter of public policy they are the only chronic conditions we wait until Stage 4 – the final stage in a chronic disease process – to treat, and then often only through incarceration.

To me, it is clear why this is the case. We have adopted a behavioral standard – danger to self or others – as a trigger to treatment.

But waiting until injury or death is imminent is no way to treat a chronic health condition. David Mechanic’s thoughtful Health Affairs article, “More People Than Ever Before Are Receiving Behavioral Health Care in the United States, But Gaps and Challenges Remain,” published in the recent August issue, examines the result of this Stage 4 thinking.

Beginning with “the devastating effects on the well-being of individuals, families, and communities,” Mechanic lays out the current state of mental health care in America. Mental illnesses rob individuals of both dignity and decades of life expectancy.

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Individual Patient Expanded Access: Developing Principles For A Structural And Regulatory Framework


July 31st, 2014

Editor’s note: In addition to Meaghan George, Sara Bencic and Darshak Sanghavi also coauthored this post. 

Individual patient expanded access, sometimes termed “compassionate use,” refers to situations where access to a drug still in the development process is granted to patients on a case-by-case basis outside of a clinical trial, prior to completion of mandated clinical trials and approval by the Food and Drug Administration (FDA). This typically involves filing a single patient or emergency investigational new drug (IND) request with the Food and Drug Administration and voluntary release of the drug by the manufacturer.

Generally, the following criteria must be met: there is reasonable expectation of meaningful benefit despite the absence of definitive clinical trial data, the patient has a serious or life-threatening condition, there are no comparable or satisfactory treatment alternatives, and there are no suitable clinical trials for the drug available to the patient. This form of expanded access, which is the focus of this paper, is different from the situation in which a drug is discharged to a large group of needy patients in the interval between successful phase 3 trials and presumed FDA approval, a strategy often termed a “treatment” IND or protocol, which was initially used in the 1980s for releasing zidovudine to patients with acquired immune deficiency syndrome.

A Call to Action: The Importance of Expanded Access Programs

The Engelberg Center for Health Care Reform at the Brookings Institution recently invited senior leaders from several pharmaceutical companies, two bioethicists, a senior FDA representative, and a patient advocate to share experiences and discuss organizational strategies related to expanded access (see acknowledgements). A driving factor for this meeting was a recent flurry of highly public cases of desperate patients seeking access to experimental drugs, which lead to social media campaigns and media coverage.

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Disparities In Access To Palliative Care


July 30th, 2014

Editor’s note: Otis Brawley also coauthored this post. This post is part of a periodic Health AffairsBlog series on palliative care, health policy, and health reform. The series features essays adapted from and drawing on an upcoming volume, Meeting the Needs of Older Adults with Serious Illness: Challenges and Opportunities in the Age of Health Care Reform, in which clinicians, researchers and policy leaders address 16 key areas where real-world policy options to improve access to quality palliative care could have a substantial role in improving value.

Racial and ethnic disparities in health care have been well documented among minority groups with respect to access to care, receipt of care, and quality of care. As a result of these disparities, minority populations are often diagnosed with late stage illness and have inferior outcomes likely leading to increased suffering.

Little is known, however, about disparities in access to and use of specialty palliative care. Palliative care is medical care aimed at relieving suffering and providing the best possible quality of life for people facing pain, symptoms, and stresses from serious illness. Palliative care is appropriate for patients at any age or illness stage and can be provided along with curative or life-prolonging therapies.

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