House Energy & Commerce Chair Cathy McMorris Rodgers to Retire: In a shock to the healthcare world, Rep. Cathy McMorris Rodgers(R-WA), Chair of the powerful Energy & Commerce Committee, has announced she will not seek re-election this year. Chair Rodgers has been pushing the senate to take up the Lower Costs, More Transparency Act (H.R.5378), which passed the House last year. Rangling has already begun to fill the top spot on the committee, with Rep. Guthrie (R-KY) a front runner. Rep. Latta (R-OH) has also announced plans to run for the chairmanship. We expect more senior members of the committee to join the race in the coming weeks.
House Ways and Means Committee Holds Hearing on Drug Shortages: On Tuesday, the House Ways and Means Committee, chaired by Rep. Jason Smith (R-MO), held a hearing on the impacts of drug shortages and potential policy solutions within their jurisdiction. Panelists pointed out that the most impactful shortages are generic sterile injectables; oncology providers stressed a need for policy to mitigate supply issues. Committee Republicans commented on their concerns with overseas production of critical drugs, especially in China, and panelists all echoed recommendations for CMS reimbursement adjustments that reward providers for finding steady supply options or establishing buffer stocks.
Senate Working Group Proposes 340B Reforms: The Senate 340B bipartisan working group released a legislative discussion draft last week. The so-called “Gang of 6” supports 340B and is working to provide clarity, transparency, and accountability in the program. Following an RFI from last year in which they received over 250responses from stakeholders, the group is continuing to seek input on patient definition, child sites, and contract pharmacy arrangements. Comments and edits to the discussion draft are due no later than April 1, 2024.
Senate HELP Committee Holds Hearing on Drug Prices with Industry CEOs: On Thursday, the Senate HELP Committee, chaired by Senator Bernie Sanders (I-VT), held a hearing on high drug prices with CEOs from Johnson & Johnson, Merck, and Bristol Myers Squibb all receiving criticism from the chair. The hearing, which was perhaps less volatile than expected, took place as all three companies sue the Biden Administration for the Medicare price negotiation policy under the Inflation Reduction Act. Sen. Sanders concluded by saying the CEO panelists’ answers were underwhelming and promised further legislation.
QALYs Bill Passes House on Party-Line Vote: On Thursday evening, the House passed H.R. 485 - The Protecting Health Care for All Patients Act on a complete party-line vote with Republicans in favor and Democrats opposed. The bill would ban federal agencies, M.A. plans, and Medicaid managed care organizations from using quality-adjusted life years (QALYs) and in coverage determinations. Rep. Buddy Carter (R-GA), a leading sponsor, said QALYs “discriminat[e] against Americans with disabilities” during his floor speech. Democrats have opposed the measure because they believe the bill language could be interpreted as impacting other measures beyond QALYs. It's unlikely the bill will progress in the Senate.
Senate Finance Committee Holds Hearing on AI in Healthcare: On Thursday, the Senate Finance Committee, chaired by Senator Ron Wyden (D-OR), held a hearing on AI’s future potential in healthcare. Majority senators, led by Wyden, said algorithms need regulation and accountability to make sure they aren’t producing bad or biased recommendations that deny care or lead to inappropriate care. Wyden also touted his Algorithmic Accountability Act.
FDA Releases Final Guidance on Supply Chain Reporting: On Tuesday, the FDA posted final guidance on CARES Act policy requiring manufacturers to submit reports on their API sources and supply chain. Registrants must submit reports on the amount of each drug manufactured, prepared, compounded, or processed for commercial distribution. Both domestic manufacturers and foreign establishments that import into the US must register with the agency. Manufacturers are given 3 weeks to comply.
Also in the news this week:
· Rep. Jimmy Gomez (D-CA) has rejoined the House Ways and MeansCommittee.
· President Biden’s White House announced they will send Congressits FY2025 budget proposal on March 11.