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.


Manchin Calls for Pause on Reconciliation Bill

Senator Joe Manchin (D-W.Va.) has called for a pause on Democrats’ work to draft a $3.5 trillion reconciliation package. Manchin argues that there are still too many economic unknowns to support moving ahead with the expensive social spending bill at this time, stating in a recent op-ed that “a pause is warranted because it will provide more clarity on the trajectory of the pandemic, and it will allow us to determine whether inflation is transitory or not.” Congressional committees have already started drafting reconciliation sections for the bill, having been instructed to report their portions of the tax and spending legislation by September 15. The House Ways and Means Committee hopes to begin their markup later this week, and the Energy and Commerce Committee expects to markup their package on September 13. Manchin’s vote will be necessary for the evenly-divided Senate to advance any reconciliation measure. While this is not the first time Manchin has expressed concerns about the total size of the reconciliation bill, with the support of Sen. Kyrsten Sinema (D-Ariz.), progressives in the House of Representatives continue to threaten to withhold support for the Senate-passed bipartisan infrastructure framework if the reconciliation package does not contain their priorities on issues such as climate change, health care, affordable housing, child care, and immigration.

House Democrats Introduce Bill to Lower Medicare Eligibility Age

More than 125 Democrats in the House of Representatives introduced the Improving Medicare Coverage Act last week (H.R. 5165) that would lower the Medicare eligibility age from 65 to 60. The legislation is led by Reps. Pramila Jayapal (D-Wash.), Conor Lamb (D-Pa.), Susan Wild (D-Pa.), Haley Stevens (D-Mich.), Joe Neguse (D-Colo.), and Debbie Dingell (D-Mich.). President Joe Biden has previously expressed support for lowering Medicare eligibility, and the lawmakers are pushing for the proposal’s inclusion in the upcoming reconciliation package. The budget resolution includes instructions to the committees for "expanding Medicare to include dental, vision, hearing benefits and lowering the eligibility age."

ONDCP Urges Congress to Act on Fentanyl Classification

Office of National Drug Control Policy (ONDCP) Director Regina LaBelle sent a letter to Congress last week asking lawmakers to permanently classify fentanyl-related drugs as schedule I substances. This designation under the Controlled Substances Act is reserved for drugs with a high potential for misuse or psychological dependence. LaBelle argues that such a permanent classification for fentanyl would aid law enforcement with pursuing traffickers and manufacturers. Her letter also outlines other fentanyl-related recommendations to help curb “the fastest growing driver of overdoses in the country, while protecting civil rights and encouraging scientific research.” The Department of Justice (DOJ) temporarily classified fentanyl-related substances as schedule I drugs in 2018. Earlier this year, Congress extended this temporary classification until October 22, 2021.

COVID-19 Booster Shots: FDA Meeting to Discuss Pfizer Booster and J&J Releases New Data

The Food and Drug Administration (FDA) has announced plans to hold an advisory committee meeting to discuss Pfizer-BioNTech’s application for a COVID-19 booster vaccine. According to director of the Center for Biologics Evaluation and Research (CBER) Peter Marks, the meeting is a part of the FDA’s “independent evaluation and determination of the safety and effectiveness of additional vaccine doses,” following the White House’s recent announcement that the administration will begin preparations for COVID-19 boosters this fall. The FDA is evaluating data submitted by Pfizer-BioNTech in a supplemental biologics license application (BLA) for its COVID-19 vaccine. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet virtually on September 17. The meeting will be livestreamed on the FDA’s YouTube channel.

FDA officials Marion Gruber and Phil Krause have announced their forthcoming departure from the agency as it weighs a decision on whether to authorize a booster shot for most Americans. Gruber has served as the director of the Office of Vaccines Research and Review since 2011 and will retire on October 31. Krause has served as deputy director since 2010 and will leave the agency the following month. Together the officials have been in charge of vaccine approvals for the duration of the pandemic. CBER Director Peter Marks will serve as acting office director of the Office of Vaccines Research and Review until the next office director is found.

In related news, Johnson & Johnson released new data last week in support of using an additional dose of the company’s COVID-19 vaccine as a booster for people previously vaccinated with the single-shot vaccine. The data indicates that a booster dose of the J&J shot resulted in a “rapid and robust” increase in spike-binding antibodies, nine-fold higher than the increase seen 28 days after the initial single-dose vaccination. The company is currently working with regulatory authorities on the use of a J&J booster as data from ongoing trials and real-world evidence continues to emerge.

2021 Medicare Trustees Report Released

The Boards of Trustees for Medicare released its latest annual report to Congress on the financial operations and actuarial status of the program last week. The Trustees assert that the COVID-19 pandemic has had only a limited impact on the hospital insurance (HI) trust fund, which they project will be able to pay full benefits until 2026. This is in keeping with the Trustees’ projections for the last two years, despite a probable decline in payroll tax revenue as a result of coronavirus-related unemployment. A September 2020 report from the Congressional Budget Office (CBO) estimated that the HI trust fund would be exhausted two years earlier, in 2024. While the Medicare Trustees Report acknowledges that the pandemic significantly affected Medicare program spending in the short term, they do not believe it will have a financial impact on the trust fund after 2024. They also expect $107.1 billion in advance payment program spending resulting from the pandemic - $67 billion of which came from the HI trust fund – to be fully repaid by September 2022. According to the report, Medicare spent $926 billion on care for 62.6 million beneficiaries in 2020, with program income reaching $900 billion.

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