This week (March 30-April 3)

Both the House and Senate are scheduled to be in recess this week, though members could be called back if there are developments on the DHS funding bill. This Week in Health Policy will not publish during the recess.

Last week (March 23-27)

Congressional Highlights

DHS funding. Early Friday morning (March 27), the Senate voted by unanimous consent to pass a bill funding all of the Department of Homeland Security (DHS) except for Immigration and Customs Enforcement (ICE) and Customs and Border Protection (CBP). If the House passes the measure, it will end a standoff that has shut down funding for the Coast Guard, Federal Emergency Management Agency (FEMA) and Transportation Security Administration (TSA) worker pay. However, the bill may face obstacles in the House, where Speaker Mike Johnson (R-LA) has said the House will not vote on the Senate-passed bill and instead, will vote on a separate bill that funds all of DHS for 60 days. The Senate adjourned early Friday for a two-week recess, placing the funding bill in limbo.

Republican senators launch new investigation. On Wednesday (March 25), Senate Health, Education, Labor, and Pensions (HELP) Committee Chair Bill Cassidy (R-LA) and Sens. Steve Daines (R-MT), James Lankford (R-OK), Cindy Hyde-Smith (R-MS), and Lindsey Graham (R-SC) launched an investigation into drug manufacturer compliance with Food and Drug Administration (FDA) marketing rules related to abortion drugs.

Administrative Highlights

White House does not name new CDC director. The White House this week did not nominate a new Centers for Disease Control and Prevention (CDC) director. National Institutes of Health (NIH) Director Jay Bhattacharya has served as acting CDC Director since Susan Monarez was fired from the position on August 27. Under the Vacancies Act, Dr. Bhattacharya could only serve as acting director for 210 days – a period that  expired on Thursday, March 26 –  though Bhattacharya will continue to serve in that capacity until someone is nominated and confirmed.

HHS names members of new Healthcare Advisory Committee. On Thursday (March 26), The Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) announced the 18 individuals who will serve on the new Healthcare Advisory Committee, which is tasked with providing expert advice on improving, strengthening and modernizing U.S. health care. The members include health care executives from across the industry, as well as health policy lawyers, academics, and physicians, among others.

CMS unveils new model focused on children’s health. On Tuesday (March 24), CMS announced a new voluntary model to support whole-person care delivery for children up to age 21 with complex medical and behavioral needs who are enrolled in Medicaid and CHIP. Under the Accelerating State Pediatric Innovation Readiness and Effectiveness Model (ASPIRE) Model, CMS will select up to five state Medicaid agencies to participate. CMS later this year will release the Notice of Funding Opportunity for state Medicaid programs to apply.

CMS extends deadline for OPPS Drug Acquisition Cost Survey. This week, CMS said it has extended to April 7 the deadline for the Outpatient Prospective Payment System (OPPS) Drug Acquisition Cost Survey (ODACS). CMS is requesting hospitals paid under OPPS and listed on this ODACS provider table submit their drug acquisition cost data to CMS by the new deadline.

DOJ continues legal defense of IRA’s drug price negotiation program. This week, the Department of Justice submitted a brief to the U.S. Supreme Court defending the Inflation Reduction Act’s (IRA) Drug Price Negotiation Program. The brief was filed in a case brought by Bristol Myers Squib and Janssen Pharmaceuticals to overturn the program, after a panel of the Third Circuit Court of Appeals tossed out the case last year.

Action is expected soon on Section 232 investigation into pharmaceuticals. President Trump is expected to issue a proclamation in the Section 232 investigation concerning pharmaceuticals and pharmaceutical ingredients imminently. By statute, the President is instructed to decide whether to act by Friday, March 27, though it is possible that deadline could slip as the Administration finalizes details.

Hearings, Markups, and Other Committee Activity

House Energy and Commerce Subcommittee on Health held a legislative hearing on “Policies to Protect Our Communities from Illicit Drug Threats.” On Thursday (March 26), the Subcommittee held a hearing during which they discussed more than a dozen bills that aim to address illicit drug threats. Republican members focused their comments on the need for stronger scheduling for emerging synthetic drugs, broader law enforcement strategies, and closing regulatory loopholes. Democratic members called for public health-led approaches, spoke critically of funding cuts to Medicaid and instability at Substance Abuse and Mental Health Services Administration, and warned against the over criminalization of illicit drug use.

• More information available here.

Reports, Studies, and Journals

• Government Accountability Office: CMS Innovation Center: Obligations and Model Testing Progress. The report provides an overview of the CMS Innovation Center, including statutory authorities, and number of models tested to date.
• Government Accountability Office: FDA Advisory Committees: More Transparency Needed on Policies for Making Conflict of Interest Determinations. The report offers three recommendations on ways FDA could improve transparency of policies that help determine conflicts of interest for FDA advisory committee members, including establishing a time frame for issuing guidance on the subject.