Category: Health Law Policy

Medicaid and the Primaries

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By Emma Sandoe

The candidates have said little about health care over the 2016 campaign season. But the debates over Medicaid expansion continue to loom large over the primary elections as the politics within states are put on display. In all of the states that are showcasing early primaries, the state legislatures are actively debating Medicaid policy.

Iowa

Iowa was the second state to expand Medicaid using the 1115 waiver authority. Since the state expanded coverage about 116,000 Iowans have gained Medicaid coverage through expansion or through the other Medicaid eligibility programs that the state offers.

Separate from the conversation about expansion the governor has proposed a controversial change to move all of the Medicaid beneficiaries onto private health insurance plans paid for by Medicaid. This ambitious plan required additional complexities such as setting up provider networks and informing beneficiaries of the change. The federal Centers for Medicare & Medicaid Services (CMS) recently asked the state to delay the implementation date. In other states, the private plans are phased in by population group (pregnant women, children, people with disabilities, etc) and often people with disabilities are excluded. Private insurers are often not equipped to provide services to high need individuals and the payment system incentivizes these high utilizers to be denied care Read More

High Deductibles and Consumer-Based Health Care

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By Zack Buck

Last week, the New York Times highlighted a recent study by Zarek C. Brot-Goldberg, et al., with fascinating implications for cost control within American health care. The paper, entitled, What Does A Deductible Do? The Impact of Cost-Sharing on Health Prices, Quantities, and Spending Dynamics, and posted by the National Bureau of Economic Research, shares that while deductibles do cause patients to use less health care, the type of health care that patients cut represents both high-quality, high-value care as well as low-value, wasteful care.

The study tracks the results of an insurance switch by a large employer—from a plan that provided free health care to a high deductible plan for its employees—and noted that the switch reduced overall spending by about 12 percent. However, while spending dropped, beneficiaries were cutting the wrong type of health care. The authors concluded that there was “no evidence of consumers learning to price shop after two years in high-deductible coverage,” finding that the beneficiaries “reduced low-value medical services and medically important ones at about the same rate, raising questions about their long-term health.” According to the authors, “90 percent of all spending reductions occur[red] in months that began under the deductible.”

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Monthly Round-Up of What to Read on Pharma Law and Policy

Ameet Sarpatwari Leave a comment

By Ameet Sarpatwari and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, in-depth analyses, and thoughtful editorials on pharmaceutical law and policy.

Below are the papers identified from the month of January. The selections feature topics ranging from the relationship between pharmaceutical marketing and innovation, to an analysis of off-label promotion rulings by the United Kingdom Prescription Medicines Code of Practice Authority, to the trends in direct-to-consumer advertising of prescription pharmaceuticals. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Arnold DG, Troyer JL. Does Increased Spending on Pharmaceutical Marketing Inhibit Pioneering Innovation? J Health Polit Policy Law. 2016 Jan 5. [Epub ahead of print].
  2. Barbour V, Burch D, Godlee F, Heneghan C, Lehman R, Perera R, Ross JS, Schroter S. Characterisation of trials where marketing purposes have been influential in study design: a descriptive study. Jan;17(1):31.
  3. Choudhry NK, Denberg TD, Qaseem A; Clinical Guidelines Committee of the American College of Physicians. Improving Adherence to Therapy and Clinical Outcomes While Containing Costs: Opportunities From the Greater Use of Generic Medications: Best Practice Advice From the Clinical Guidelines Committee of the American College of Physicians. Ann Intern Med. 2016;164(1):41-9.
  4. Greene JA, Anderson G, Sharfstein JM. Role of the FDA in Affordability of Off-Patent Pharmaceuticals. 2016 Jan 4. [Epub ahead of print].
  5. Kesselheim AS, Hwang TJ. Breakthrough Medical Devices and the 21st Century Cures Act. Ann Intern Med. 2016 Jan 19. [Epub ahead of print].
  6. Lieberman DA, Polinski JM, Choudhry NK, Avorn J, Fischer MA. Medicaid prescription limits: policy trends and comparative impact on utilization. BMC Health Serv Res. 2016;16(1):15.
  7. Vilhelmsson A, Davis C, Mulinari S. Pharmaceutical Industry Off-label Promotion and Self-regulation: A Document Analysis of Off-label Promotion Rulings by the United Kingdom Prescription Medicines Code of Practice Authority 2003-2012. PLoS Med. 2016;13(1):e1001945.
  8. Wu MH, Bartz D, Avorn J, Seeger JD. Trends in Direct-to-Consumer Advertising of Prescription Contraceptives. 2016 Jan 22. [Epub ahead of print].

Blinding as a Solution to Bias

The Petrie-Flom Center Staff Leave a comment

Blinding Bias

We’re pleased to announce that a new book by Petrie-Flom Center affiliates Christopher Robertson and Aaron Kesselheim will be available this week.  The edited volume — Blinding as a Solution to Bias: Strengthening Biomedical Science, Forensic Science, and Law — grew from a 2013 conference at Harvard co-sponsored by the Petrie-Flom Center.  From the fascinating history of blinding (starting in Ben Franklin’s living room to test the healing powers of Mesmerism) to the sham surgeries being used today, and the future novel uses of blinding in the courts, the book moves the debate forward.  What are the advantages and limitations of blinding compared to other solutions for biases? How can we quantify the biases in unblinded research? Can we develop new ways to blind decision-makers?  What are the ethical problems with withholding information?  Fundamentally, questions about who needs to know what open new doors of inquiry for the design of scientific research studies, regulatory institutions, and courts.  With a foreword by Larry Lessig, the book surveys the theory, practice, and future of blinding, drawing upon leading authors with a diverse range of methodologies and areas of expertise, including medicine, law, forensic sciences, philosophy, economics, psychology, sociology, and statistics.  It is available for pre-order from the publisher and Amazon.com.

Liability for Mobile Health and Wearable Technologies

Nicolas P. Terry Leave a comment
By Nicolas Terry
Lindsay Wiley and I just posted Liability for Mobile Health and Wearable Technologies that is forthcoming in Annals of Health Law. As we argue–Most of the legal commentary regarding mobile health has focused on direct regulation leveraging existing laws and regulators such as HIPAA privacy through HHS-OCR or device regulation by the FDA. However, much of the mobile health revolution likely will play out in lightly regulated spaces bereft of most of the privacy, security, and safety rules associated with traditional health care. This article examines the potential for common law liability models to bridge these gaps (even on a temporary basis).
Download the paper on SSRN here.

‘The Week in Health Law’ Podcast

Nicolas P. Terry Leave a comment

By Nicolas Terry

This week featured Deven McGraw, Deputy Director for Health Information Privacy at the U.S. Department of Health and Human Services’ Office for Civil Rights. Deven has been an influential figure in health law for years, both as a partner at Manatt, Phelps & Phillips, LLP (and co-chair of its Privacy and Data Security practice) and as head of CDT’s Health Privacy Project.

twihl 5x5Our lightning round featured Nic’s takes on a recent certificate of need case, a JAMA article on high-deductible plans, and superbugs on duodenoscopes. Frank covered the NY Times’s blockbuster article on drug shortages, and Politico’s data-driven angle on Biden’s “cancer moonshot.”

We then focused on Deven’s work, covering many topics in health privacy and security. OCR hopes that its recent guidance on access to health records will empower patients. Cloud computing and the “internet of health things” are huge concerns. OCR is innovatively offering FAQ pages for developers and others on the frontlines of health care’s technological advance, and welcomes their (and your) questions!

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at iTunes, listen at Stitcher Radio, Tunein and Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on twitter @nicolasterry @FrankPasquale @WeekInHealthLaw

Breaking News: NAM Releases Report on Mitochondrial Replacement Therapy (Part I Summary)

I. Glenn Cohen Leave a comment

By I. Glenn Cohen

As readers know I’ve written on mitochondrial replacement therapy and its attendant ethical and regulatory issues. Today the National Academy of Medicine (formerly known as the IOM) released a terrific report today with its recommendations. I’ll have a second post with my reactions but here is a summary from the report of their recommendations. The big headline is they have recommended FDA largely move towards allowing it to go forward under a regulatory pathway with restrictions, the most important of which is the transfer only of male embryos (to avoid germ-line issues).

In the NAM’s own words:

Recommendation 1: Initial clinical investigations of mitochondrial replacement techniques (MRT) should be considered by the U.S. Food and Drug Administration (FDA) only if and when the following conditions can be met: Read More