#6Things That Happened in Health Policy This Week

6 Things That Happened in Health Policy This Week is produced by a mix of research assistants from the Healthcare Quality & Outcomes (HQO) Initiative at the Harvard T.H. Chan School of Public Health. In each edition we feature a variety of news articles, reports, and studies focused on U.S. health policy and health services research. This week’s edition is from Kim Reimold (@kimreimold), Zoe Lyon (@zoemarklyon), Yevgeniy Feyman (@yfeyman) and Raj Pammal (@rspammal). 

Modern Healthcare: FDA officials say better system is needed to track medical devices

  • In a JAMA editorial, FDA Commissioner Robert Califf and the director of the FDA’s Center for Devices and Radiological Health, Jeffrey Shuren, argue that the FDA’s system for tracking Medical Devices is flawed.
    • Currently, FDA-approved devices must demonstrate safety and effectiveness.
    • But pre-market trials to demonstrate this may not necessarily reflect how the device is used in practice, and might miss important adverse events.
    • Post-market trials are rarely conducted.
    • Reporting of adverse events relies on physicians, and requires identifying patterns after-the-fact.
    • Approximately 50,000 adverse events are reported each year, leading to 3,000 deaths.
  • The two suggest that the agency’s forthcoming plan for reform will call for an independent entity involving multiple stakeholders to gather data from various registries, insurance claims, and electronic health records.
    • Unique device identifiers would also better help track adverse events by allowing faster identification of potentially problematic devices. Congress has already required all devices to have these identifiers by 2020.
    • Including such identifiers in patient health records is also important.

NYT: Obama Offers Ways to Improve His Health Care Law

  • In an article for JAMA, President Obama defends the ACA while offering ideas to improve on it. Suggested avenues for reform include:
    • A “public option” to ensure adequate competition on the ACA’s marketplaces
    • Expanded subsidies to help the remaining 29 million uninsured purchase coverage
  • Because the law has cost less than original estimates, President Obama also argues that Congress could fund such ideas while still staying below projections.
  • Obama’s support for the public option aligns him with Hillary Clinton’s recent support for a Medicare buy-in.
  • The President also accused pharmaceutical companies of refusing to consider reforms to drug pricing in order to protect their profits, and Republicans for “hyperpartisanship” in refusing to compromise on the health care law, and resisting complete expansion of Medicaid.

Health Affairs: Medical Marijuana Laws Reduce Prescription Medication Use in Medicare Part D

  • Legalization of medical marijuana has been very controversial over the years but little is actually known about its clinical use.
  • Used data on prescriptions filled by Medicare Part D enrollees from 2010 to 2013
  • Findings:
    • Use of prescriptions drugs where medical marijuana could serve as an alternative – including opioids – have decreased significantly.
    • On average, in states where marijuana is legalized, 1,826 fewer daily doses for pain were prescribed.
    • There was also a reduction in depression medications by an average of 265 daily doses.
  • Policy implications:
    • Increasing the number of states (currently 24) in which medical marijuana is legalized could reduce some costs in Medicare.
    • May need to change the categorization of marijuana from a Controlled Substance in order to reflect its clinical benefits

NPR: HHS Report Say Obamacare Plans are Cheaper than They Look

  • Haters consistently hate on Obamacare because cost-sharing appears to be out of control.
  • However, a Center for Medicare and Medicaid study that accounted for deductible and copayment subsidies found that cost-sharing is not nearly so absorbent.
  • People whose incomes are 250 percent of the federal poverty level or below qualify for cost reduction subsidies.
  • In fact, the median deductible for those with Obamacare was $850 or $50 less than last year.
  • These findings contrast with those of the Kaiser Family Foundation which found that the average deductible was over $3000 – when not accounting for subsidies.
  • CMS adds that many services also come free even before patients meet their deductible and plans cover annual checkups and vaccines with no copayments.

Time: Zika Funding Bill Fails as Congress Is Unable to Reach Compromise

  • A failed vote in the Senate on Thursday means that no funding will be provided to combat the Zika virus.
    • Zika has already infected over one thousand people in the United States and over one million people in Central/South America
  • Though both Democrats and Republicans previously agreed on the importance of preventing the spread of Zika, political disagreements outweighed health warnings and resulted in the withholding of funding for research and prevention
  • Since Congress will now recess until September, public health officials will have to execute Zika disease management protocol without crucial resources that may have come from the funding bill
  • Apart from there being no drug or vaccine for the virus, its is difficult to track the transmission of Zika and therefore monitor the disease
  • Senate majority leader Mitch McConnell (R-KY) and Senator Harry Reid (D-NV) exchanged words over the political maneuverings that caused the bill to fail

WSJ: Amgen Biosimilar Gets Thumbs-Up From FDA Panel

  • AbbVie’s arthritis-treating drug Humira, the second-biggest selling drug in the world ($15 billion revenue last year), will likely face competition from an Amgen biosimilar
  • A panel of FDA advisers has endorsed the cheaper alternative drug, known as ABP 501, which will likely result in future FDA approval of the drug
  • As this drug and other “biosimilars” are far less expensive than high-costing biotech drugs that have historically lacked competition, they could save billions of dollars for patients, providers, and insurers in the coming year
  • The first such approval of a lower-cost biosimilar came last year with Novartis’s Zarxio
  • Experts estimate that the new wave of biosimilars will result in discounted drug prices between 15% and 30% of traditional specialty drugs

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