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CMS Proposes Coverage For Lung Cancer Screening With Low Dose CT


December 9th, 2014

On November 11, the Centers for Medicare and Medicaid Services (CMS) released its Proposed Decision Memo for Screening Lung Cancer with Low Dose Computed Tomography (LDCT), which is expected to be finalized in mid-December. Despite a negative assessment by its own advisory committee, CMS has proposed coverage with evidence development (CED) for an annual “lung cancer screening counseling and shared-decision-making visit” and, for appropriate beneficiaries, additional screening with LDCT.

Under CED, Medicare provides conditional coverage for a new treatment or technology while additional data is collected to confirm its effectiveness and make a final determination. Through this proposed decision, CMS has followed the lead of numerous other expert and advisory groups, which have concluded that the overall benefits of such screening for at-risk individuals outweigh concerns regarding gaps in evidence, generalizability and potential harms.

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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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The United States’ Misguided Self-Interest On Ebola


October 31st, 2014

The Ebola epidemic in West Africa is spiraling out of control. The international community allowed a manageable outbreak to mushroom into a health and humanitarian crisis. The World Health Organization (WHO) has been enfeebled and largely sidelined. Belatedly, the United States sent military troops into Liberia and spearheaded a United Nations Security Council resolution. Yet since isolated Ebola cases have appeared on our shores, the US has begun to look inward, at risk of falling into a trap that I will call “misguided self-interest.”

While the West African epidemic rages, the US delayed significant action until long after the unprecedented nature of the Ebola epidemic became clear, and even now the response is incommensurate with the massive need. Now we are transferring our gaze from the real crisis and headed on an insular journey.

I grant the premise that a country’s first responsibility is to protect its inhabitants. But calls for a travel ban from the region and newly announced state quarantine policies that would ensnare travelers from affected countries appear selfish. To put it in perspective, the US has experienced only a few domestically diagnosed cases, with an exceedingly low risk of an outbreak.

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Integrity In Retail Health Care: Rethinking The Sale Of Tobacco Products


September 3rd, 2014

Retail health care is a relatively new development in American health care.  It is true that much of the dispensing of medications has historically occurred through retail pharmacies, which sold a variety of other goods and services, but somehow that was not seen as the provision of health care.   Health care institutions, including doctors’ offices, hospitals and clinics, were the places that people went to be diagnosed and treated.  And those institutions did little other than health care; they did not, and still do not today, offer any products other than provision of care, including testing and treatment.  As such, these institutions demonstrated high integrity, defined as a state of being whole, and synonymous with cohesion and unity of purpose.

Now retail pharmacies, mass merchandisers and grocery stores are adding “health care” as another consumer good to be purchased on a mass scale.  Retail health care is in some cases, extending what the pharmacist does in the retail pharmacy: providing more advice about a variety of health care issues, giving vaccines, and working more closely with doctors’ offices.  In other cases, it is the opening of small clinic practices, often staffed by nurse practitioners, caring for minor ailments.  These kinds of clinics make great sense from the point of view of convenience and cost and have proven to be very popular, particularly given the shortage of convenient primary care that exists in many communities.

There are signs that the scope of retail health is deepening.  Pharmacies are planning to do more laboratory testing, in part to support a broader array of health advice from pharmacists, and in part to allow a wider set of complaints to be addressed in the retail pharmacies.  Walgreens has developed accountable care organizations with hospital partners.  At CVS Health, we have been very public about our effort to align with integrated delivery systems to help them manage population health by emphasizing joint efforts to improve medication adherence, support the management of complex patients, and create direct electronic medical record connectivity between our 900 retail clinics and the doctors’ offices.  Just last month, Walmart announced that their new clinics would be primary care offices, capable of caring for a range of chronic disease.

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Recent Health Policy Brief: E-Cigarettes And Federal Regulation


July 11th, 2014

The latest Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation (RWJF) describes federal policy makers’ recent efforts to propose rules for e-cigarette regulation. E-cigarettes, virtually non-existent ten years ago, have skyrocketed in popularity, including among people who claim to use e-cigarettes as a tool to help them quit smoking altogether.

The 2009 Family Smoking Prevention and Tobacco Control Act gave the Food and Drug Administration (FDA) authority to oversee the manufacture, marketing, distribution, and sale of regulated tobacco products such as cigarettes, tobacco in cigarettes, roll-your-own, and smokeless tobacco. But it left unregulated other tobacco products such as cigars, pipe and hookah tobacco, nicotine gels, and e-cigarettes.

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Interview: IOM President Harvey Fineberg Reflects On Lessons Learned


July 10th, 2014

On June 16, 2014, I spoke with Dr. Harvey V. Fineberg, as he wrapped up his second six-year term as president of the Institute of Medicine (IOM). We discussed how requests for work come to the IOM, the attributes of IOM reports that make them effective, and how the IOM maintains a strong voice in a crowded field.

Dr. Fineberg shared lessons learned from his analysis of events surrounding the Swine Flu immunization effort of 1976, and how, today, those lessons help him guide the IOM’s thinking about program assessment. We also discussed Dr. Fineberg’s work to bring together the various arms of the National Academies of Sciences to improve health.

You can listen to the full podcast at Health Affairs. These are a few of my favorite quotations taken from our discussion:

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Health Affairs Entry Point: The Science Behind Alzheimer’s Disease


April 30th, 2014

The Department of Health and Human Services (HHS) recently released the 2014 update on its National Plan to Address Alzheimer’s Disease, including strategies for identifying and expanding research in the prevention of Alzheimer’s. In the April issue of Health Affairs, senior editor Jonathan Bor reports on the science behind the disease and the implications for future funded research.

In “The Search For Effective Alzheimer’s Therapies: A Work in Progress,” Bor illustrates that in the thirty years since research began on the disease, no one has discovered a cure or effective ways to chronically manage the condition. Regardless, HHS intends to find a suitable treatment by 2025, as outlined in its National Plan, reports Bor.

Even though research suggests a protein is to blame for altering the brain’s make-up and therefore contributing to the onset of Alzheimer’s, there’s disagreement on which protein bears the responsibility. Furthermore, the results of clinical trials aimed at combating the negative effect of protein plaque buildup, have been surprisingly disappointing, says Bor.

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What’s Past Is Prologue: Making The Case For PET Beta-Amyloid Imaging Coverage


April 9th, 2014

Editor’s note: This post is published in conjunction with the April issue of Health Affairs, which features a series of articles on Alzheimer’s disease.

In September of 2013, CMS issued its final decision memo that concluded positron emission tomography- amyloid beta (PET Aβ) imaging is “not reasonable or necessary”, finding “insufficient evidence” that use of this diagnostic tool would improve health outcomes for patients with dementia or neurodegenerative disease. As such, PET Aβ imaging to help diagnose Alzheimer’s disease (AD) is not a covered service for Medicare beneficiaries except for those enrolled in CMS-approved clinical trials.

CMS’ final decision underscores the emerging new paradigm for coverage decision-making, requiring innovators not only to demonstrate to FDA’s satisfaction that their products are effective, but also to prove to CMS and other payors that their use will improve clinical outcomes. This paradigm will increase confidence in the value and health benefit of new technologies, although it will make the path to coverage more difficult and uncertain for diagnostic developers.

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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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Collaborative Filtering: An Interim Approach To Identifying Clinical Doppelgängers


June 17th, 2013

“The real challenge of human biology, beyond the task of finding out how genes orchestrate the construction and maintenance of the miraculous mechanism of our bodies, will lie ahead as we seek to explain how our minds have come to organize thoughts sufficiently well to investigate our own existence.”

The initial enthusiasm following the mapping of the human genome has given way to a more circumspect outlook. With the exception of a small number of promising interventions, advances in genomic science have yet to yield a critical mass of therapeutic breakthroughs – thus forestalling the birth of the era of precision medicine (PM).

While a comprehensive genomic understanding of disease and concomitant molecular-based patient taxonomy would doubtless hasten the arrival of PM, a significantly less costly alternative offers a promising interim approach. A methodology known as collaborative filtering (CF) which has already achieved widespread use in advertising and marketing, has the potential to offer powerful insights not only to advertisers and others desiring to influence purchasing behavior but also to physicians, allied health care professional, patients, and their families by offering personalized advice and recommendations regarding health and disease.

CF relies directly on aggregated subject/user behavior to reveal complex and unexpected patterns that would otherwise be difficult to capture using known data attributes. Recommendations generated from analyses of these patterns have demonstrated significantly greater reliability than those using more traditional demographic categories. The core idea behind applying CF to clinical decision-making is to make decisions about a patient based on historical data derived from multiple “similar” patients presenting multiple “similar” cases. As Victor Streecher explains, “collaborative filtering in the health area could match the coping strategies, medical decisions, and preferences of similar others with specific needs and interests of the user.”

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Rapid Learning For Precision Medicine: A Big Data To Knowledge (BD2K) Initiative


February 21st, 2013

Proposal

The National Research Council’s Precision Medicine report found that it is imperative to create a new scientific base for biomedical research, clinical care, and public health that accurately reflects the genetic variations in diseases and in individual responses to therapies.

This proposal calls for using the nation’s rapidly expanding capabilities for computerized biomedical research to accomplish this goal as quickly as possible. Research databases and analyses for most diseases would be completed over the next three years (by the end of 2015).

Background

The US-led Human Genome Project was finished ten years ago (2003). In the past several years, key elements for moving forward on a Precision Medicine-type initiative have been coming together.

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A Cure For Patent Pathology? The Supreme Court Reviews The Patentability Of Human Genes


December 7th, 2012

“Are human genes patentable?” On November 30, 2012, the U.S. Supreme Court agreed to answer this single question in Association for Molecular Pathology v. Myriad Genetics. Of course, the petitioners, including health care providers, professional associations, and patients, worded the question to favor the answer they want: “No, human genes are not patentable.” For Myriad Genetics, the patent owner who would like its patent rights upheld, the question is better phrased as whether one can patent “isolated molecules of deoxyribonucleic acid that were identified and defined by human inventors.”

The practical stakes in the Court’s decision, which should come in the first half of 2013, are enormous. The U.S. Patent and Trademark Office (USPTO) has issued tens of thousands of patents on genetic sequences over the past few decades, and the U.S. Court of Appeals for the Federal Circuit, the appellate court entrusted with hearing virtually all U.S. patent appeals, has never declared such sequences to be non-patentable subject matter. For more than a century, patents have issued on isolated versions of naturally occurring substances other than DNA.

Many believe that gene patents are crucial to the modern biotechnology industry. On the other hand, many researchers and clinicians feel that gene patents, particularly human gene patents, are commonly unnecessary to spur innovation and in fact interfere significantly with scientific and technological progress, whether by slowing or diverting research, impeding the provision of diagnostic tests, or generally increasing costs for clinical and scientific work.

The patents at issue in Myriad make such concerns particularly poignant. These patents relate to BRCA1 and BRCA2, genes associated with a predisposition to breast cancer. The obvious public interest in ready access to cancer diagnosis helps account for the fact that petitioners’ lead lawyers are not the normal high-priced advocates for a private company accused of patent infringement. Instead, those lawyers work for the American Civil Liberties Union Foundation, an organization more commonly associated with battles for civil rights than rights in technological innovations.

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The Million Veteran Program: Building VA’s Mega-Database for Genomic Medicine


November 19th, 2012

This year marks the fiftieth anniversary of Watson and Crick (and Wilkins) being named Nobel Prize recipients for discovering DNA, the genetic code. In the half century since, there has been an exponential growth of knowledge and accomplishment based on their findings. More recently, a confluence of scientific and technical advances have made possible vast progress in our understanding of human disease, its diagnosis, and the most effective treatment(s). Among these advances are genetic testing, high performance computing platforms, and the electronic health record (EHR), which together offer the possibility of clinically rich databases that link genetic information to treatment outcomes.

These and other advances have made it clear that the genetic predispositions to adult diseases are in many cases extremely complex. In its early phases, human genetics focused on single genes for single diseases that generally occurred in childhood; e.g., Tay-Sachs disease. The genomics of adult diseases—such as coronary heart disease—are associated with complexity resulting from multigene interactions and strong environmental influences (e.g., lifestyle and exposures), that may in some cases result in organ-specific “epigenetic” changes that modify DNA.

A prominent example of how these various factors come together can be seen by looking at diabetes. Having a gene associated with diabetes may modestly increase one’s chances of developing this condition from—let us say—6 to 12 percent. But whether diabetes actually results is influenced by additional factors, such as the sequences of other genes, environmental influences (such as diet and exercise), and age.

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PCORI’s Problem: Reasons Are Not Causes


November 5th, 2012

Editor’s note: In another Health Affairs Blog post also published today, Joe Selby, the executive director of the Patient-Centered Outcomes Research Institute, responds to David Introcaso’s post below. For more on the concept of patient centeredness, comparative effectiveness research, and the Patient-Centered Outcomes Research Institute, see Health Affairs‘ October issue, “Current Challenges In Comparative Effectiveness Research.

This past May, the Patient-Centered Outcomes Research Institute (PCORI) approved five research priority areas: “assessment of prevention, diagnosis and treatment options”; “improving health care systems”; “communication and dissemination”; “disparities”; and, “patient-centered outcomes research and methodological research”. In June PCORI announced 50 pilot project research awards totaling $30 million. PCORI is anticipated to spend $3 billion between now and 2019.

What does it mean to be “patient centered” and what does this then mean about ways of “improving “health care systems” and “communication and dissemination”? PCORI belies its “patient centered” mandate since it has not put a primacy on understanding and improving the interaction between the patient and the provider — the only way the quality of health care delivery is ultimately improved. None of the fifty PCORI pilot projects examine the quality of these interactions. Understanding and improving patient-provider interactions also explains how clinical evidence is produced or becomes meaningful.

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New IOM Report Addresses Growing Complexity Of Health Care


September 6th, 2012

Health Affairs Blog commends to readers today’s newly released Institute of Medicine report, “Best Care At Lower Cost: The Path To Continuously Learning Health Care In America.” The report states that “achieving a learning health care system – one in which science and informatics, patient-clinician partnerships, incentives, and culture are aligned to promote and enable […]

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Misguided Genetic Exceptionalism


August 3rd, 2012

While society should be careful about its uses of genetic testing and its efforts to modify the genome, some people overreact when dealing with DNA. Consider two recent examples reported in the media. A genetic cancer test. In a fascinating series on genetics in medicine, Gina Kolata reported in the New York Times on a genetic test […]

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Celebrating The End Of The HIV/AIDS Travel Ban


July 20th, 2012

This year’s International AIDS Society (IAS) conference, taking place in the US for the first time after a 20-year boycott, has a special meaning to me.  As an infectious diseases doctor, I provide primary care to HIV-positive patients.  I first became drawn to HIV/AIDS in 1989 when I was 10 years old.  At that time […]

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New Health Affairs: Assessing The President’s Emergency Plan For AIDS Relief


July 10th, 2012

Articles published yesterday in the July 2012 issue of July 2012 issue of Health Affairs focus on the President’s Emergency Plan for AIDS Relief (PEPFAR), the US program to address global HIV and AIDS, and the largest investment to date of any country to fight a single disease.  The thematic issue examines the origins of […]

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Get A Grippe: Lessons Learned From The Controversy Over Publication Of Pandemic Flu Research


May 8th, 2012

If one were to try and identify what issue has most roiled the biomedical community in the past few months it is surely the effort to censor two papers describing genetic modifications of the H5N1 flu virus. Background.  Last December, the U.S. National Science Advisory Board for Biosecurity (NSABB) was asked by the U.S. National […]

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Health Affairs Briefing Reminder: Environmental Challenges For Health


May 3rd, 2011

Tomorrow, on Wednesday,  May 4, Health Affairs will hold a Washington D.C. briefing in connection with its first ever issue on environmental health. National environmental health and policy experts will discuss the state of environmental health and its future, and will present new research in the field. The briefing and Health Affairs issue on environmental […]

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