Healthcare Today | September 15, 2023

Updated Coronavirus Vaccines Approved by FDA. On Tuesday, the White House announced that the FDA and CDC had approved and recommended new Pfizer and Moderna COVID-19 vaccines for all Americans before the winter months. The new doses, with boosters to protect against emerging variants, will begin national availability beginning next week.

September Congressional Toplines. Both chambers of Congress returned from recess with a tumultuous week, with House Speaker Kevin McCarthy unable to progress spending bills to a House floor vote and rumors of a motion to vacate his Speakership circulating. The House Freedom Caucus has proven unwilling to see progress on government funding bills without numerous conservative social priorities, raising the odds of a government shutdown at the end of the month. The Senate has slowly progressed bipartisan spending bills, with more likely coming to the floor next week. Most notably, Senate leadership will begin votes on a partial “minibus” package (including Veterans and Agriculture/FDA) early next week.

Energy and Commerce Drug Shortage Legislative Hearing. On Thursday, the Health Subcommittee held a hearing on America’s ongoing drug shortages, highlighting the 300-plus products in short supply due primarily to production and supply chain issues. With representatives from GPOs, Yale School of Medicine, and pharmacy associations, many panelists and Democratic legislators pointed out their issues with full Committee Chair Cathy McMorris Rodgers’ (R-WA) Supply Chain Stop Drug Shortages Act discussion draft, stating Congress should instead finance drug stockpiling and studies on where America’s generic ingredients are sourced.

House Oversight Committee Holds Year in Review Hearing for Inflation Reduction Act. The House Committee on Oversight and Accountability Subcommittee on Healthcare and Financial Services held a hearing on Thursday to examine the impacts of the Inflation Reduction Act (IRA) a year after its passage. Republican Members and GOP-invited witnesses focused on the negative impacts of the IRA on healthcare. Specifically, they focused on negative impacts of the IRA on access to care for vulnerable populations, costs, the future availability of innovative treatments, and lack of transparency and accountability in how the IRA is implemented. Democrats argued that the IRA has substantially lowered drug prices and therefore increased access to care since its introduction.

CMS Releases List of Part B Rebatable Drugs. On September 13, CMS announced 34 Part B drugs for which Part B beneficiary coinsurances may be lower for Q4 2023 under the Inflation Reduction Act. The federal government has stated that it “intends to invoice drug manufacturers… no later than fall 2025” for these rebates, which will be deposited into the Medicare Trust Fund. Information about the drugs on the list are available here, and a fact sheet detailing the program and the coinsurance reduction is available here.

Nominee for NIH Director Confirmation Hearing Back on Track After Sanders Drops Hold. Senate Health, Education, Labor, and Pension Committee Chairman Bernie Sanders said last Friday that he will finally hold a confirmation hearing next month for Biden’s Director of National Institutes of Health nominee Dr. Monica Bertagnolli. Sanders had been keeping the hearing in limbo since spring, saying he would block any nominee under the HELP Committee’s jurisdiction until he saw a sufficient plan from the White House to lower the cost of prescription drugs. The NIH is currently the only health agency that has a vacancy relying on Senate action.

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