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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?

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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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The Latest Health Wonk Review

November 21st, 2014

In this week’s “turkey edition” of the Health Wonk Review, David Harlow of HealthBlawg provides a veritable smorgasbord of health policy posts, including a Health Affairs Blog essay by Jordan Paradise on biosimilars and patent disclosures.

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Battle Lines Drawn Over Biosimilar Application And Patent Disclosure Process

November 17th, 2014

The Biosimilars Price Competition and Innovation Act of 2009 (BPCIA) introduced a long-awaited, and highly-supported, abbreviated route to market for “biosimilar” and “interchangeable” biologic products. The goal was to create incentives for development and reduce health care costs in the same way that previous legislation had accomplished in the generic arena over three decades ago.

However, widespread criticism of BPCIA provisions to facilitate interactions between biosimilar applicants and reference biologic sponsors regarding application submission and patent status was swift and unrelenting. Attorneys practicing in the realm of Hatch-Waxman litigation for generic drugs balked at the drastic differences between the familiar public process grounded in required patent disclosures, FDA Orange Book listings, and generic applicant certifications and the private, iterative process set forth in the BPCIA. Legal scholars, industry representatives, and practitioners alike projected that a courtroom battle regarding real-world operation of the provisions was imminent.

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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.

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

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


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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Is A Study Of HIV Treatment For Mothers In Africa Unethical?

October 1st, 2014

A global health controversy erupted this summer when the prominent scientific journal Nature ran an article entitled “HIV trial attacked.” Within, commentators squared off over whether a huge ongoing study provides suboptimal and thus unethical treatment options to mothers with HIV in the developing world.

The multinational PROMISE study (for Promoting Maternal and Infant Survival Everywhere) is enrolling thousands of pregnant women with HIV in hopes of comparing mortality and other clinical outcomes between mothers who receive lifelong HIV therapy to mothers who receive shorter treatment durations if they have less advanced HIV disease.

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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 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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The Role Of Black Box Warnings In Safe Prescribing Practices

August 20th, 2014

In the Health Affairs article, “Era of Faster Drug Approval Has Also Seen Increased Black-Box Warnings and Market Withdrawals,” published in the August issue, Cassie Frank and coauthors compare the number of approved prescription drugs that received black-box warnings or were withdrawn from the market for safety-related reasons prior to the 1992 Prescription Drug User Fee Act (PDUFA) with black-box warnings and safety-related withdrawals in the post-PDUFA era.

PDUFA for the first time authorized FDA to collect user fees from brand-name manufacturers that submitted New Drug Applications, with the funds being earmarked for more review staff (not until 2007 were funds also permitted to be used to expand post-approval safety surveillance capacity).

As a quid pro quo, the FDA was required to act on all new drugs within a fixed deadline: drugs given priority review designations because they were particularly promising therapies offering substantial improvements in treating serious conditions were to be reviewed within 6 months and standard review drugs were to be reviewed within 12 months (later shortened to 10 months in 2002). By all accounts, PDUFA substantially expedited the review process. The review times for new molecular entities decreased from an average of 33.6 months between 1978 and 1986 to about 10 months for drugs approved between 2001-2010.

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

July 31st, 2014

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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Ethical Dilemmas In Prison And Jail Health Care

March 10th, 2014

Editor’s note: This post is published in conjunction with the March issue of Health Affairs, which features a cluster of articles on jails and health.

Prison and jail health care, despite occasional pockets of inspiration, provided by programs affiliated with academic institutions, is an arena of endless ethical conflict in which health care providers must negotiate relentlessly with prison officials to provide necessary and decent care.  The “right to health care” articulated by the Supreme Court pre-ordained these ongoing tensions.  The court reasoned that to place persons in prison or jail, where they could not secure their own care, and then to fail to provide that care, could result in precisely the pain and suffering prohibited by the Eighth Amendment to the Constitution.

Good reasoning was followed by a deeply flawed articulation of the “right” that defines the medical care entitlement as care provided to inmates without “deliberate indifference to their serious medical needs.” By forging a standard which was, and remains, unique in medicine and health care delivery — designed to avoid intruding on state malpractice litigation regarding adequacy of practice and standards of care — the court guaranteed that dispute would surround delivery.  That first framing, which did not establish a right to “standard of care” or to care delivered according to a “community standard,” set the stage for endless ethical and legal conflict.

The Eighth Amendment’s deliberate indifference standard, forbidding cruel and unusual punishment, presents a relatively demanding standard for proving liabil­ity.  The Eighth Amendment, as interpreted by the federal courts, does not render prison officials or staff liable in federal cases for malpractice or accidents, nor does it resolve inter-professional disputes — or patient-professional disputes — about the best choice of treatment. It does require, however, that sufficient resources be made available to implement three basic rights: the right to access to care, the right to care that is ordered, and the right to a professional medical judgment.

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Workplace Wellness Programs: Continuing The Discussion With Ron Goetzel

October 30th, 2013

We imagine that reading a point-by-point reply to Professor Ron Goetzel’s lengthy rebuttal to our previous reply, which responded to a previous lengthy rebuttal by Professor Goetzel to our original article, would try the patience of even the most dedicated readers of Health Affairs. Therefore, beyond reminding readers of the original article’s scope, here we use Professor Goetzel’s last response as a touchstone to summarize our difficulties with the arguments by advocates of workplace wellness programs based on financial incentives. We ask weary readers who do not wish to continue with this exchange, but are interested in workplace wellness, to look at the evidence we provide in our appendices, and make their own judgments.

First, we must remind Professor Goetzel that we wrote our original article to address the assumptions underlying workplace wellness programs based on substantial financial incentives — those encouraged by the Affordable Care Act — and not any of the other types of programs. That article did not comment on the myriad other public health interventions that might take place at the worksite, although some of our arguments could be applied to those programs as well. Unfortunately, many of Professor Goetzel’s comments are directed at claims we never made about those other programs, and we find his continued advocacy for those programs in the guise of a response to our work distracting.

Second, Professor Goetzel’s most recent posting helpfully outlines ACA wellness regulations that were released after we published our article. Like other commentators, he is right to highlight the new, expansive “reasonable alternative standard,” because it may mean that many more employees can access alternatives to the program standards. Once again, however, he is more optimistic than we and other researchers are that such protections will be easily accessed by employees. We are skeptical that it will be nothing more than a simple matter for an employee to exempt themselves from the general program. Among other things, the employee needs to know about the possibility of an alternative and to feel that asking for an alternative will not harm her, and her employer must be willing to comply.

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Applying Comparative Effectiveness Research To Individuals: Problems And Approaches

October 29th, 2013

A Comparative Effectiveness Research (CER) study shows that surgery is better than medical treatment for a particular cardiac condition. My patient is 78 years old and has complicated diabetes. – does the study apply? Another patient 48 years old and otherwise healthy. Does it apply here?

Can the overall results of a CER study be applied to all patients in the target population? Are there substantial, undetected variations among patients in the results of CER? What is the extent of exceptions? These are important policy questions in applying results of CER to day-to-day decisions, clinical guidelines, performance measures and other facets of the modern healthcare system.

The “gold standard” approach to CER is the randomized (RCT), a scientific comparison of two or more clinical strategies, with the downsides that it is generally conducted in a special environment and usually has a rather narrow (and possibly unrepresentative) population spectrum. Two variants, the Practical (or Pragmatic) Clinical Trial (PCT) and the Large Simple Trial (LST) are inclusive of a wider spectrum of patients and more diverse clinical settings.

These approaches provide “average” results and for the most part it is thought that averages do apply to a large segment of the population at large for which they are intended. However, there are clearly differences in effect (heterogeneities of treatment effect – HTE’s) that manifest among CER study subjects and presumably to a greater extent in the intended population outside the study. Two approaches may be equivalent on the average but one may be better in a particular group, and differences may be less apparent when the study’s population base is narrow. A long list of factors contribute to these HTEs for CER and other trials – comorbidities, severity of illness, genetics, age, medication adherence, susceptibility to adverse events, ethnicity, site, economics and others.

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Inside the Gray Zone: Reflections on Gautham Suresh’s Narrative Matters Essay

October 21st, 2013

Note: This piece was written in collaboration with John. Lantos, director of the Bioethics Center at Children’s Mercy Hospital.

“I just caution you that we don’t know what we don’t know.”

These words came from one of my senior faculty members at Children’s Mercy Hospital in Kansas City, Mo. The context and tone of her warning made me clench my teeth. As a young neonatology fellow, I wanted to think that we did know.

But it turns out, the senior faculty member was right. Her words may have been the most important lesson I’ve learned during my neonatology fellowship. When it comes to the most premature of babies, there is far more uncertainty than certainty. I have learned to recognize this, and believe that it is the key to being a good neonatologist.

In the October Health Affairs Narrative Matters Essay, Dr. Gautham Suresh recounts the tension that he experienced when resuscitating an infant at the borderline of viability. The essay raises the issues of parental decision making, the high rate of premature birth in the United States, and the always touchy issue of resource allocation.

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Narrative Matters: A Doctor Faces Tough Decisions On Infant Resuscitation

October 16th, 2013

In the October Health Affairs Narrative Matters essay, a neonatologist must decide whether to revive a premature baby on the borderline of viability. Gautham Suresh’s article is freely available to all readers; or you can subscribe to iTunes and listen to him read it. Next week on Health Affairs Blog, another neonatologist will react to Dr. Suresh’s thoughts and describe her own experiences grappling with the difficult decisions that too often accompany the treatment of very premature babies.

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The Privacy Conundrum And Genomic Research: Re-Identification And Other Concerns

September 11th, 2013

No matter what the arena — finance, health care, or national security — questions surrounding the provision of personal data are always the same: how much benefit vs. how much risk? Who handles these data, and can those individuals be trusted? How do organizations guard against data misuse? What are the legal safeguards to protect privacy, and are they sufficient in an era when more data are shared more widely?

Nowhere is the privacy discussion more personal than in genomics, the very hardwiring of our existence. Genomic data are unique to individuals (or identical twins) and, except for occasional mutations, do not change over a lifetime, thereby rendering disclosures permanent. Genomic data also have special properties regarding privacy, especially as comprehensive whole genome sequencing becomes the major technique.

The benefits of amassing genomic data in sufficient case numbers for validity and making this knowledge available to an appropriately wide body of expert investigators are extensive. Research derived from genomic databases offers potentially large health payoffs. Genomics can help scientists predict who will develop a disease (e.g., Huntington’s Disease) and tailor treatments. It also holds the potential to bring about a paradigm shift in how we think about and classify disease; i.e., allowing us to move from the pathology-based approach begun in the late 19th century — which focuses on the progression of disease in a specific organto a biochemical-and genomics-based approach. This new approach is already being applied to a number of diseases, including certain cancers.

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Workplace Wellness Programs: Continuing The Discussion With Dinardo, Horwitz, And Kelly

August 21st, 2013

This is a response to the DiNardo, Horwitz, and Kelly Health Affairs Blog post in which the authors replied to my previous commentary, “Structuring Legal, Ethical, and Practical Workplace Health Incentives: A Reply to Horwitz, Kelly, And DiNardo.” In my prior post, I highlighted my disagreements with many of the points made by Horwitz et al. in their Health Affairs article entitled “Wellness Incentives in the Workplace: Cost Savings through Cost Shifting to Unhealthy Workers.” This post continues that dialogue.

I begin this commentary with some hesitation. I want to be clear that my intent in posting these blogs is not to “dig in my heels.” In fact, I fully understand, appreciate, and empathize with DiNardo et al.’s positions. They are rightfully concerned about protecting poor, minority, and disenfranchised workers whose rights may be threatened by unscrupulous employers who wish to place the onus on employees to “become healthy” or “else” — the “else” meaning paying a higher health insurance premium than their “healthy” counterparts. I appreciate that DiNardo et al. are protecting the interests of workers who, through no fault of their own, have become ill and are now faced with the prospect of paying more for health care coverage because of their illness.

Let me unequivocally state that paying more for health insurance because you are ill or have certain health risk factors is not the goal of workplace health promotion (wellness) advocates. Quite the opposite is true. Our intent is to keep workers healthy for as long as possible so that they can be spared the human and financial burden of paying for health care services that might otherwise have been avoided. The point of workplace wellness programs is to inspire people to improve their health behaviors and biometric measures so that they do not suffer from illnesses that are to a large degree attributable to lifestyle practices — e.g., lung cancer, type-2 diabetes, chronic obstructive pulmonary disease (COPD), and coronary heart disease (CHD).

In my previous post, I highlighted ways to structure incentive programs so that they are fair and contain provisions to guard against abuse. Here, I address additional challenges to workplace health promotion programs posed by DiNardo et al.

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Toward A Scientific Approach To Workplace Wellness: A Response To Ron Goetzel

July 1st, 2013

We thank Health Affairs for the opportunity to respond to Professor Ron Goetzel’s comments on our recent Health Affairs article, “Wellness Incentives in the Workplace: Cost Savings through Cost Shifting to Unhealthy Workers.” In many respects our article was quite limited in scope. We started by noting that companies are increasingly adopting wellness programs based on the idea that, with the help of financial incentives, employees will improve their health and employers will save money. We set out to explore the assumptions underlying this idea and found scarce high-quality evidence on the subject of workplace wellness incentives. What evidence we found offers, at best, limited support to justify these assumptions.

We hope that others will conduct the much needed research about whether financial incentives can change behavior, improve health, and control spending. We also hope that the body of causal research will be expanded to a wider variety of populations, such as the elderly, and other related issues, such as the effects on incentives of absenteeism, productivity, and long term health, or to programs that do not involve financial incentives or do not claim to control costs. These other effects and other types of programs are worthy of consideration, but we have not considered them in our article.

The Ethics Of Incentive Programs

Unfortunately, Professor Goetzel misunderstood the scope of our research. Contrary to Professor Goetzel’s assertions, we did not suggest that people should avoid making choices consistent with their health (and other goals), or that employers should not act in the best of interest of employees, employees’ health, or society at large. Still, we are skeptical that wellness programs of the sort encouraged by the Affordable Care Act (ACA) create, as Professor Goetzel suggests, a “win—win—win” situation: good for all workers, good for society, and consistent with the financial interests of employers, firms, and their owners. Rather remarkably, despite the potential for workplace wellness to become a large “social experiment”, we found scant reliable evidence that implementing wellness programs can easily save costs through health improvements without being discriminatory.

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Unpacking The Meaning Of ‘Rationing': A Response To Dowd And Allison

June 27th, 2013

Bryan Dowd and Kirk Allison are to be thanked for their lengthy treatise on the word “rationing.” It is a term whose interpretation economists have left to politicians — not invariably models of erudition. Check the subject index of introductory textbooks or even intermediary textbooks in economics and rarely will you see there the term “rationing.”

Part of the lack of clarity on the term can be laid at the doorsteps of the profession that claims to know all about resource allocation but rarely ever takes up the subject of rationing in its teaching. Sadly, modern textbooks in economics are, by and large, just copies of one another — worse than me too drugs in which at least one molecule is changed. At some point, someone forgot to cover the term, so all other texts followed.

But another reason for the lack of clarity on the term reflects the fact that even economists cannot seem to agree on its meaning.

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Improving The Rhetoric Of Rationing: Part 1

June 24th, 2013

Note: Rationing of health care services is a contentious topic and in our view, current discussions of rationing often are unproductive or harmful. We suggest two reasons for that result. First the discussants are imprecise in their use of the term rationing – often for politically motivated reasons. Second, the discussants write about rationing as an activity that “we” will undertake, with significant consequences for “you.” It would be more helpful to discuss the prudent use of health care services in terms of the health plan that we would want for ourselves and our families.

In part 1 of this post below, we address the first problem by offering a more precise definition of rationing. In part 2 of this post [which will appear on Health Affairs Blog tomorrow], we address the second problem by describing the type of health plan we would like for ourselves and our families.

“Rationing,” and particularly “government rationing” is politically charged rhetoric. Merely mentioning the possibility of government rationing of health care services has a chilling effect on health policy debates. For example, some of the early criticisms of comparative effectiveness research (CER) were based on the possibility that the research would be used as a basis for coverage decisions in public insurance plans, especially Medicare.

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Seven Ways For Health Services Research To Lead Health System Change

May 30th, 2013

With ACA implementation now at hand — and with it, the formation of accountable care organizations (ACOs) — health services research (HSR) has an especially important role to play. As ACOs take steps that will substantially change health care delivery, the ability to measure and improve health system performance and acquire this data efficiently will be in greater demand. Is HSR up to the challenge?

As the “basic science” of the health care system, HSR focuses on access, cost, and quality. Health services researchers work to identify and assess vital signs of a well-functioning health care system and develop performance measures for examining system aspects. They also seek to improve the system by identifying gaps in quality and then testing and disseminating solutions to those problems. HSR’s goals and often its approaches are different from the development, testing, and translation of new drugs or other interventions.

But as we’ve seen all too frequently, the necessity of responding to ongoing change within the health system outpaces HSR’s ability to produce timely evidence. As a result, large scale changes are sometimes instituted on the basis of imperfect evidence (e.g., tying financial incentives to measures of physician or hospital performance before studies are completed). Or, as we’ve also seen, by the time a research project comes full cycle — proposed, funded, conducted, and published — external or internal forces impacting the health system may have rendered the original question moot. Within the VA, for example, studies regarding the effectiveness of telehealth interventions often have been overtaken by these technologies’ rapid dissemination throughout the system. For HSR to fulfill its mission of helping transform health care, it first must be able to transform itself.

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