Hart Health Strategies provides a comprehensive policy briefing on a weekly basis. This in-depth health policy briefing is sent out at the beginning of each week. The health policy briefing recaps the previous week and previews the week ahead. It alerts clients to upcoming congressional hearings, newly introduced bills, regulatory announcements, and implementation activity related to the Patient Protection and Affordable Care Act (PPACA) and other health laws.


White House Releases “Most Favored Nation” Drug Pricing Order

The White House released its latest executive order (E.O.) on drug pricing on Sunday that would ensure that Medicare pay no more than the lowest price for a drug than it is sold for in any Organisation for Economic Co-operation and Development (OECD) country with a comparable per capita GDP. The E.O. directs the U.S. Department of Health and Human Services (HHS) to immediately begin a demonstration project to test the “most favored nation” approach under Medicare Part B. A similar model would be implemented for Medicare Part D for those products without competition for which patients pay prices higher than in comparable OECD nations. The President had previewed a version of the directive last month, but provided industry time to propose an alternative policy before moving forward. The President’s deadline passed, however, without pharmaceutical companies and the administration reaching an agreement on an alternative plan.

Democrats Block Slimmed-Down COVID Package

On Thursday, the Senate rejected a narrow coronavirus stimulus bill offered by Senate Republicans by a vote of 52-47, failing to achieve the needed 60-vote procedural threshold. Sen. Rand Paul (R-Ky.) was the only Republican to vote against the legislation. The package, with a cost of approximately $500 billion, included a $300 increase in weekly federal unemployment benefits through December 27, liability protections from coronavirus-related lawsuits, and extended the Paycheck Protection Program (PPP). It also included $16 billion for testing, contact tracing, and surveillance and $31 billion in funding for vaccine, therapeutic, and diagnostic development.

Democrats hoped that by blocking the scaleddown bill they would force Republicans back to the negotiating table on a more comprehensive solution. The parties remain at odds on several issues, including unemployment insurance and funding for state and local governments. The $3.5 trillion HEROES Act was passed by the House of Representatives in May, and Senate Republican leadership introduced the $1.1 trillion HEALS Act in late July. There are no talks currently scheduled between Democratic leadership and the White House, however, increasing the chances that Congress will not reach a deal until after the November presidential election. Congress is currently scheduled to recess in early October. Currently, no House votes are scheduled from October 5 to November 15. The Senate’s current calendar includes a recess from October 12 to November 6.

Meanwhile, House Speaker Nancy Pelosi (D-Calif.) and Treasury Secretary Steven Mnuchin have agreed to use a stopgap spending measure to avoid a government shutdown come the end of the fiscal year on September 30th but have yet to determine the timetable for the continuing resolution (CR). The expectation is that a deal would fund the federal government through the beginning of December. The House’s last scheduled day in session is December 10, while Senate Majority Leader Mitch McConnell (R-Ky.) is targeting December 18 for adjournment.

COVID Vaccine Trial Halted, CEOs Pledge Commitment to Safety

AstraZeneca announced that it has halted its COVID-19 vaccine clinical trial to review safety data while investigating a single adverse event that occurred in a person enrolled in one of its studies. The company characterized the pause as a routine action taken so that an independent review of a potentially unexplained illness could be conducted. This is the first safety issue that has arisen for the several coronavirus vaccines in late-stage trials. AstraZeneca’s vaccine is being developed in partnership with scientists at Oxford University. Phase three trials are currently taking place in the U.S., U.K., Brazil, and South Africa. It is one of the vaccines receiving support from the White House’s Operation Warp Speed; the federal government has agreed to pay up to $1.2 billion toward the development and manufacturing of 300 million doses.

The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna Inc., Novavax Inc., Pfizer Inc., and Sanofi have signed a pledge outlining their commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The companies pledge to always make the safety and well-being of vaccinated individuals their top priority, continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes, to only submit for approval or emergency use authorization (EUA) after demonstrating safety and efficacy through a phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities, and to work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

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