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.


Lawmakers Reach Deal on Government Funding/ Coronavirus Relief

Republican and Democratic congressional leadership reached a deal on a nearly $900 billion coronavirus relief stimulus package ahead of the Sunday night government funding deadline. While the text of the agreement has yet to be finalized, according to statements by senate leadership, the COVID package will include enhanced unemployment relief and $600 direct impact checks for individuals. It also includes $25 billion in direct rental assistance, an extension of the moratorium on evictions, and small business relief through $284 billion for the Paycheck Protection Program (PPP). More than $30 billion would be provided to support the procurement and distribution of COVID-19 vaccines. The emergency relief bill will not include employer liability protections or direct assistance for state and local governments. The COVID plan will be attached to a $1.4 trillion spending package to fund the federal government through the end of the fiscal year on September 30, 2021. The final omnibus will include a ban on surprise medical bills. While the details of the surprise billing provision have not yet been released, it is expected to be similar to the compromise reached by the leaders of the House Ways and Means, Energy and Commerce, Education and Labor, and Senate Health, Education, Labor, and Pensions (HELP) committees last week. This evening, Congress passed a 24-hour continuing resolution (CR) to keep the government funded through December 21 to provide additional time to finalize the text of the agreement. A final vote on the omnibus/COVID-19 package is expected sometime tomorrow.

Moderna COVID Vaccine Granted EUA as Pfizer Begins Distribution

The first COVID-19 vaccine shots were distributed across the country last week. Officials estimate that the first shipment contained roughly 2.9 million doses of the Pfizer-BioNTech vaccine, with an additional 2.9 million doses retained by the government so that the first vaccine recipients can be ensured a second shot. The government will announce new weekly allocations each Friday. According to U.S. Department of Health and Human Services (HHS) Secretary Alex Azar, the plan is to have 20 million people get their first shot in the month of December and their second dose in January. By the end of March, the hope is to have 100 million Americans who have received at least one dose. The Centers for Disease Control and Prevention (CDC) recommended the first vaccines go to health care workers and those in long-term care facilities. Six cases of anaphylaxis among the 272,001 doses of the Pfizer shot administered as of Saturday morning have been identified in the U.S. Pfizer and the FDA are revising fact sheets handed out with the vaccine to provide more detailed instructions for health care providers; the CDC recommends that everyone receive monitoring for 15 minutes after receiving the vaccine, while individuals with a history of severe allergic reactions be monitored for 30 minutes.

According to White House officials, President Trump will receive the vaccine as soon as his medical team recommends it. Vice President Pence, his wife, and Surgeon General Jerome Adams were vaccinated on Friday during a televised event, and members of Congress have also begun to receive the new COVID-19 vaccine at the recommendation of the attending physician as a part of continuity of government protocols. President-elect Biden and his wife will receive their first dose of the vaccine on Monday, while Vice President-elect Harris and her husband will get their first shots the following week. Supreme Court justices have been told by the Capitol physician’s office that they will be eligible to receive their shots in the coming days.

The Food and Drug Administration (FDA) granted emergency use authorization (EUA) on Friday to Moderna for the use of its coronavirus vaccine in people 18 years of age and older, making it the second vaccine to be cleared by the agency since the start of the pandemic. The Moderna EUA follows a 20-0 vote, with one abstention, from the FDA’s independent advisory panel that the known and potential benefits of the vaccine outweigh the known and potential risks. Similar to the shot produced by Pfizer Inc. and BioNTech, the vaccine uses mRNA technology and is administered in a two-dose regimen. Moderna’s vaccine, however, does not need the special equipment that Pfizer’s requires to be kept at an extremely cold temperature.

The CDC’s Advisory Committee on Immunization Practices (ACIP) voted 11-9 over the weekend to recommend Moderna’s vaccine. Delivery of the Moderna product to the U.S. will begin immediately. Moderna expects to be able to produce 20 million doses for the U.S. by the end of the year, and another 85 million to 100 million doses in the U.S. in the first quarter. The company plans to seek full approval of the vaccine next year.

Senate Passes Additional Health Legislation

The Senate approved several pieces of health-related legislation by unanimous consent last week. The School-Based Allergies and Asthma Management Program Act (H.R. 2468) encourages schools to implement management plans to help students identify and control their asthma and allergies and reduce absenteeism. The Advancing Research to Prevent Suicide Act (H.R. 4704) directs the National Science Foundation to support research on the science of suicide. The Ensuring Innovation Act (S. 1636) amends the Food, Drug, and Cosmetic Act with respect to chemical exclusivity and aims to ensure that exclusivity is not awarded to products which do not represent a true innovation. The Data Mapping to Save Moms’ Lives Act (S. 3152) requires the Federal Communications Commission (FCC) to incorporate maternal health outcomes into its broadband health maps. The Cannabidiol and Marihuana Research Expansion Act (S. 2032) expands research on cannabis and marijuana. H.R.7898 requires HHS to consider certain recognized security practices of covered entities and business associates when making certain determinations. The Henrietta Lacks Enhancing Cancer Research Act (H.R. 1966) requires the Government Accountability Office (GAO) to complete a report reviewing how federal agencies address barriers to participation in federally-funded cancer clinical trials by individuals from underrepresented populations.

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