This week (October 20-24)

The Senate is in session this week with a few health care hearings on the calendar, while the House is expected to remain out of session.

Senate Health, Education, Labor and Pensions Committee will hold a hearing on "The 340B Program: Examining Its Growth and Impact on Patients."

• Date: Thursday, October 23 at 10AM ET
• More information available here.

Senate Special Committee on Aging will hold a hearing on "Modernizing Health Care: How Shoppable Services Improve Outcomes and Lower Costs."

• Date: Wednesday, October 22 at 3:30PM ET
• More information available here.

Last week (October 13-17)

Congressional Highlights

U.S. government shutdown continues. Republicans and Democrats remain at an impasse over reopening the federal government. On Thursday (October 16), the Senate took a 10th vote in relation to the House-passed CR (H.R. 5371), which failed 51-45 without any new support in addition to the existing three Democratic "yes" votes (Senators Cortez Masto, Fetterman, and King). Four senators didn't vote, and Senate Majority Leader John Thune (R-SD) changed his vote to "no" for procedural reasons. "All we need are five courageous Democrats with a backbone who aren't afraid to buck their leadership who are marching them right over a cliff," Senate Majority Leader Thune said Wednesday. Another vote related to the CR is set for Monday, October 20 at 5:30 p.m. The House has remained in recess.

While there have been reports that lawmakers are considering a bevy of options to temporarily extend or modify the ACA's enhanced premium tax credits, no formal deal has been reached. Senate Majority Leader Thune more directly offered Democrats a vote on the subsidy extension within a specific timeframe, but only after they provide the necessary votes to pass the House-passed CR and reopen the federal government. "We can guarantee you get a vote by a date certain," Leader Thune said on MSNBC. "At some point, Democrats have to take 'yes' for an answer." Punchbowl News reported Leader Thune as saying he has offered Democrats a two-vote deal: one on opening the government, the other on a separate one-year extension of enhanced premium tax credits. Senate Democratic leader Chuck Schumer (D-NY) told reporters he was unaware of such an offer.

Senate Finance Committee Democrats launch inquiry into Medicaid contractors. On Monday (October 10), Senate Finance Committee Ranking Member Ron Wyden (D-OR), along with Sens. Elizabeth Warren (D-MA), Bernie Sanders (I-VT), and Raphael Warnock (D-GA) sent letters to four large Medicaid contractors, raising concerns about eligibility system errors and the ways in which states may implement the One Big Beautiful Bill Act's Medicaid work requirement provision.

Administrative Highlights

Trump, EMD Serono announce MFN deal. On Thursday (October 16), President Donald Trump and EMD Serono, the U.S. health care business of Germany-based Merck KGaA, announced a Most Favored Nations deal that aims to lower the cost of some drugs needed for in-vitro fertilization in exchange for protection from future tariffs. The deal, which largely follows the format of those with Pfizer and AstraZeneca, includes:

• Direct access for patients. Under the deal, EMD Soreno will offer direct-to-consumer (DTC) sales at discounted prices of its complete portfolio of IVF therapies. Certain products, including Gonal-f® (follitropin alfa injection) will be available at TrumpRx
• MFN pricing for Medicaid. EMD Soreno will provide their products at MFN prices to every State Medicaid program.
• Future proofing fairness. EMD Soreno will guarantee MFN prices on all new innovative medicines that come to market.
• Shared savings. EMD Soreno will repatriate increased foreign revenue on existing products
• Onshoring: EMD Soreno will invest in manufacturing in the U.S. on specific negotiated timelines.

EMD Soreno said it had made a deal with the U.S. Commerce Department to exclude its drugs from industry-specific tariffs, if those are introduced, provided the company meets its commitments on U.S. manufacturing and research.

FDA awards first national priority vouchers. On Thursday (October 16), the FDA awarded the first-ever Commissioner's National Priority Vouchers (CNPVs) to nine sponsors for products addressing key national priorities. Selected products include therapies for infertility, Type I diabetes, nicotine addiction, deafness, blindness, pancreatic cancer, porphyria, and drugs supporting domestic manufacturing. Under the pilot program, recipients will receive a decision 1-2 months after a complete application, with the FDA reserving flexibility to extend timelines if necessary.

Medicare issues telehealth claim guidance. On Wednesday (October 15), CMS issued updated guidance directing Medicare Administrative Contractors (MACs) to hold claims with dates of service October 1, 2025 or later for telehealth services impacted by expired health programs. The notice states that telehealth services provided in the beneficiary's home as part of a Medicare Shared Savings Program (MSSP) Accountable Care Organizations (ACOs) remain covered under Medicare. CMS clarified that claims for non-impacted programs should continue to be paid.

Executive Highlights

Judge pauses HHS RIFs. On Wednesday (October 15), a federal judge in San Francisco issued a temporary restraining order prohibiting the Trump Administration from issuing additional reduction-in-force (RIF) notices to furloughed federal workers. The ruling came a day after HHS in a document filed in the case explained that the agency had mistakenly sent RIF notices to 1,760 workers, instead of the intended 986 workers. Some staff were brought back to continue their roles. Media reports suggest most of the RIFs impacted the Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration, and Health Resources and Services Administration.

Reports, Studies, and Journals

• HHS Office of Inspector General: Summary Report of Prior Office of Inspector General Penetration Tests of 10 State MMIS and E&E Systems. The report, which details the findings of an audit of 10 states' Medicaid Management Information Systems and Eligibility & Enrollment systems, shows the systems succeeded in preventing "unsophisticated" cyberattacks but needed updates to protect against more advanced cyberthreats.
• Kaiser Family Foundation: ACA Marketplace Premium Payments Would More than Double on Average Next Year if Enhanced Premium Tax Credits Expire. The analysis found a hypothetical individual making $28,000 would see annual premium payments increase $1,238 for a benchmark plan if the ACA's enhanced subsidies expire.