This Week in Washington: CMS releases 2025 MA and Part D proposed payment Advance Notice; CMS sends first fair drug price offers to Drug Price Negotiation Program companies; SAMHSA releases final rule making virtual prescribing of buprenorphine permanent; Biogen pulls Aduhelm from market; Supreme Court to hear mifepristone case oral arguments on March 26.
Congress
House
House Budget Committee to Mark Up Preventive Health Savings Act
This week, the House Budget Committee is expected to mark up the Preventive Health Savings Act. The legislation would alter the manner in which the Congressional Budget Office (CBO) provides cost estimates for preventive healthcare policies. It would require the CBO to calculate the budgetary effects for two additional 10-year periods for healthcare policies that result in reductions to budget outlays. CBO currently limits its cost estimates to a window of 10 years.
House Energy and Commerce Committee Health Subcommittee Holds Hearing on Healthcare Costs
On Jan. 31, the House Energy and Commerce Committee Health Subcommittee held a hearing on healthcare spending and discussed how Congress could work toward lowering cost growth and improving transparency. Announced witnesses were:
- Chapin White, Ph.D., Director of Health Analysis at the Congressional Budget Office
- Sophia Tripoli, MPH, Senior Director of Health Policy at Families USA
- Kevin Lyons, Plan Administration at the New Jersey State Policemen’s Benevolent Association, Inc.
- Benedic Ippolito, Ph.D., M.S., Senior Fellow at the American Enterprise Institute
- Katie Martin, MPA, President and CEO of the Health Care Cost Institute
For more information, click here.
House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic Holds Hearing on HHS Compliance
On Jan. 31, the House Committee on Oversight and Accountability Select Subcommittee on the Coronavirus Pandemic held a hearing to discuss the Department of Health and Human Services’ compliance with the subcommittee’s requests for documents and information concerning its response to the COVID-19 pandemic. Announced witnesses were:
- The Honorable Melanie Egorin, Department of Health and Human Services Assistant Secretary for Legislation
For more information, click here.
Biogen Pulls Aduhelm from Market Citing CMS and FDA Decisions
On Jan. 31, Biogen announced that it would pull its Alzheimer’s drug Aduhelm (aducanumab) from the market due to limited Centers for Medicare and Medicaid Services (CMS) coverage and additional Food and Drug Administration (FDA) study requirements needed for full approval. The FDA had granted Aduhelm accelerated approval in June 2021.
Long-term critic of CMS’ coverage policy Rep. Guthrie (R-KY) stated at an Alzheimer’s event on Jan. 30 that he was disappointed with the announcement. In 2022, CMS issued a national coverage determination that blocked Aduhelm and other Alzheimer’s drugs that target amyloid beta plaque from receiving Medicare coverage except for when they are administered in clinical trials.
Senate
Senate Majority Leader Leads Democrats in Sending Amicus Brief to Supreme Court Concerning Mifepristone Access
On Jan. 30, Senate Majority Leader Chuck Schumer (D-NY) and House Minority Leader Hakeem Jeffries (D-NY) led all 263 Democratic members of Congress in sending an amicus brief to the U.S. Supreme Court. The amicus brief urges the court to reverse rulings by the U.S. Court of Appeals for the 5th Circuit and U.S. District Court for the Northern District of Texas that seek to roll back the Food and Drug Administration’s (FDA) decision to expand access to mifepristone by allowing patients to take the drug later in pregnancy and removing the in-person dispensing requirement.
The members argue that the rulings threaten the health of pregnant patients, exacerbate existing reproductive healthcare challenges and jeopardize the FDA’s drug approval process.
For more information, click here.
Senate Finance Committee Favorably Reports Nomination of HHS Assistant Secretary of Planning and Evaluation Nominee
On Jan. 31, the Senate Finance Committee held an executive session to consider the nominations of Marjorie A. Rollinson, to serve as Chief Counsel for the Internal Revenue Service, and Dr. Rebecca Haffajee, to serve as the Assistant Secretary for Planning and Evaluation at the Department of Health and Human Services.
The committee reported both nominations favorably on a 16-11 and 14-13 vote. The senators who opposed Dr. Haffajee’s nomination include Republican Sens. Crapo (ID), Grassley (IA), Cornyn (TX), Thune (SD), Scott (SC), Cassidy (LA), Lankford (OK), Daines (MT), Young (IN), Barrasso (WY), Johnson (WI), Tillis (NC) and Blackburn (TN).
For more information, click here.
Senate Finance Committee Chairman Announces Hearing on AI
On Feb. 1, Senate Finance Committee Chairman Ron Wyden (D-OR) announced that the committee will hold a hearing on Feb. 8 on the use of algorithms and artificial intelligence in healthcare. Announced witnesses are:
- Peter Shen, Head of Digital and Automation for North America at Siemens Healthineers
- Mark Sendak, M.D., M.P.P., Co-Lead of the Health AI Partnership
- Michelle M. Mello, J.D., Ph.D., Professor of Health Policy and Law at Stanford University
- Ziad Obermeyer, M.D., Associate Professor and Blue Cross of California Distinguished Professor at the University of California – Berkeley
- Katherine Baicker, Ph.D., Provost at the University of Chicago
For more information, click here.
- The Honorable Melanie Egorin, Department of Health and Human Services Assistant Secretary for Legislation
For more information, click here.
Read more on healthcare policy in McGuireWoods Consulting’s Washington Healthcare Update.