Month: February 2016

President Obama Introduces Evidence Generation Strategy to Reduce High Drug Costs

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By Elizabeth Guo

Addressing the high cost of drugs was at the top of President Obama’s list in his fiscal year 2017 budget, released last week. Many of his proposals were familiar. The President hoped to increase manufacturer contributions to prescription drug coverage under Medicare Part D and wanted to shorten the length of biologic market exclusivity from twelve to seven years. These proposals were also in the President’s fiscal year 2016 budget but were not put into place.

However, the budget also included a number of surprising, new proposals that underscore how post-market evidence might play an increasing role in controlling drug prices in coming years. Rachel Sachs has written about the role that the Centers for Medicare and Medicaid Services (CMS) can play in keeping down drug prices, and it seems like some of these ideas are gaining traction:

Modify reimbursement of Part B drugs. The White House estimates that changes to Medicare Part B payments could save the country $7.75 billion over ten years. Medicare Part B covers drugs and services dispensed in an outpatient setting. Many of the most expensive biologic drugs are currently covered under Medicare Part B. The budget proposal did not elaborate on how the White House hopes to change Part B payments, but the proposal likely refers to recommendations released by the Medicare Payment Advisory Commission (MedPAC) last June. MedPAC’s 2015 report recommended that Congress link Part B payments to clinical effectiveness evidence. For example, the government could group drugs with similar health effects and pay all drugs in each group the rate of least costly product in the group. This approach relies on having reliable clinical effectiveness data so that researchers can easily compare the relative effectiveness of two or more drugs. Read More

TOMORROW (2/18)! Assessing the Viability of FDA’s Biosimilar Pathway

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16.02.18, FDA Biosimilars Pathway posterAssessing the Viability of FDA’s Biosimilar Pathway
February 18, 2016 12:00 PM
Pound Hall, Room 100
Harvard Law School
1536 Massachusetts Ave., Cambridge, MA

Description

The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.  Read More

Working conference on ethics of randomized trials in development economics and health policy

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An opportunity for graduate students and young scholars; application deadline March 11

Applications are invited for participating in a five day working conference and summer school on ethical issues posed by randomized trials in development economics and health policy, to be held June 20-24 at the beautiful Brocher Foundation villa in Hermance, Switzerland.

The conference offers trainees and younger scholars in development economics, global health, ethics, and related fields and areas of practice an opportunity to participate in five full days of debate and discussion with leading scholars. Those include Angus Deaton (Princeton; this year’s Nobel Laureate in Economics), Michael Marmot (UCL; current President, World Medical Association), Josh Angrist (MIT), Adam Wagstaff (World Bank), Tyler Cowen (George Mason University), Will MacAskill (University of Oxford), Nancy Cartwright (Durham), and many others.

Selection of the applicants will be made by the conference directors, Profs. Nir Eyal and Daniel Wikler (Harvard University), Dr. Anders Huitfeldt (Stanford University), Prof. Samia Hurst (University of Geneva).

The application deadline is March 11, 2016. Further information is available at the Brocher website. For remaining questions, please email Dr Huitfeldt, at anders@huitfeldt.net.

Expanding Coercive Treatment Is The Wrong Solution For The Opioid Crisis

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By Leo Beletsky, Wendy Parmet, and Ameet Sarpatwari

Cross posted from Health Affairs Blog

Amidst a surging crisis of opioid abuse and overdoses, many policymakers have called for expanded use of coercive treatment. Many states, including Massachusetts, already allow physicians, police, and court officers to seek a court order authorizing involuntary addiction treatment (formally referred to as substance use disorder (SUD)). But new legislation, The Act Relative to Substance Use Treatment, Education, and Prevention (STEP) currently before the Massachusetts state legislature (H.3944) could expand the scope of involuntary treatment and reduce judicial oversight.

This proposal is an ill-considered response to a public health crisis. To be sure, policymakers face an understandable pressure to take decisive action. But this approach fails to balance that imperative for speed and public confidence with sound scientific, legal, and ethical principles.

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The Testosterone Rule Strikes Again – New Policy to Address Transgender Athletes

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New Guidelines issued by the IOC (International Olympic Committee) offer a new policy for the participation of transgender athletes in sports competitions. According to the new policy, transgender athletes should be given the option to compete without having to undergo genital re-construction surgery. Female to Male (F-M) transgender athletes will be allowed to compete without further limitations, however Male to Female (M-F) transgender athletes would be allowed to compete only after receiving hormonal treatment intended to keep testosterone levels under a fixed threshold for at least a year before the competition. This is a significant change to the previous guidelines, which recommended that transgender athletes be eligible to compete only after a genital re-construction surgery and two years of hormonal therapy. The committee explained that the change of policy was due to “current scientific, social and legal attitudes on transgender issues”. The overriding objective of all policies according to the IOC was ‘fair competition’, so whereas genital appearance was not considered to affect fairness, testosterone levels are still understood to generate a competitive edge.

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‘The Week in Health Law’ Podcast

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By Nicolas Terry

This week we interviewed Charles Ornstein, a senior reporter for ProPublica covering health care and the pharmaceutical industry. ProPublica has been at the cutting edge of twihl 5x5technology, health, and privacy reporting, and Ornstein’s work there has exposed both the personal narratives and hard data behind an American epidemic of privacy violations. We cover some of his recent hits in this conversation, and reflect on what it would take to see an effective health privacy regime in the US. HITECH geeks will love the discussion of “accounting of disclosures” at the end.

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

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

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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].