McDermott+ Check-Up: October 3, 2025 - McDermott+

McDermott+ Check-Up: October 3, 2025

THIS WEEK’S DOSE


  • Government shuts down. The shutdown went into effect at 12:01 am EDT on October 1, 2025. Failure to reach an agreement on a short-term spending deal means that certain healthcare provisions have expired, departments are operating with only essential employees, and uncertainty continues.
  • White House continues drug pricing push. With the possibility of tariffs looming, drug companies and associations announced efforts aimed at lowering drug costs, and the administration announced future policies.
  • President Trump signs EO on pediatric cancer research. The executive order (EO) seeks to accelerate pediatric cancer research using artificial intelligence.
  • CMS releases Medicare Drug Price Negotiation Program final guidance for the third cycle. The Centers for Medicare & Medicaid Services (CMS) outlined changes to the negotiation program and preparations for the next round of drug announcements.
  • CMS issues guidance on Medicaid managed care coverage for immigrants. The letter to state Medicaid directors reinterprets statute related to emergency services for “aliens ineligible for full Medicaid benefits.”

CONGRESS


Government shuts down. Early in the week, President Trump met with Democratic leaders Schumer (NY) and Jeffries (NY) and Republican leaders Thune (SD) and Johnson (LA), but no deal was reached to keep the government open ahead of the September 30, 2025, funding deadline. Democratic leaders were unwilling to concede on key healthcare policies, such as repealing the One Big Beautiful Bill Act’s (OBBBA’s) Medicaid provisions and extending the Marketplace enhanced advanced premium tax credits (APTCs).

The Senate held several votes this week on the same two stopgap spending bills that failed to advance last week, demonstrating that a path forward remains elusive:

  • The Republican-led continuing resolution (CR) would fund the government through November 21, 2025, at current levels and would extend other expiring healthcare policies. This CR passed the House but has repeatedly failed to get the 60 votes necessary to overcome the filibuster in the Senate. The latest vote was 54 – 45, with Sen. Paul (R-KY) voting against and Sens. Cortez Masto (D-NV), Fetterman (D-PA), and King (I-ME) joining Republicans in voting for the CR.
  • The Democratic-led CR would fund the government through October 31, 2025. It would reverse OBBBA’s Medicaid cuts and permanently extend the enhanced APTCs for Affordable Care Act coverage. The latest Senate vote on this bill failed 53 – 47 along party lines.

As a result of the failed votes, the government shut down on October 1, 2025, and several health programs tied to the government funding deadline also expired. A bipartisan group of senators have been discussing a path forward to end the shutdown, including Sens. Kaine (D-VA), Rounds (R-SD), Gallego (D-AZ), Hoeven (R-ND), Sullivan (R-AK), Murkowski (R-AK), Tuberville (R-AL), and Shaheen (D-NH). The group is said to be considering a short-term CR (through mid-October) and compromising on a short-term APTC extension. These discussions do not appear to include leadership at this time.

During past shutdowns, federal workers deemed nonessential have been furloughed and have received backpay after the government reopens. During this shutdown, Office of Management and Budget Director Russel Vought announced his intention to also lay off large numbers of federal workers, although such actions have not occurred yet.

The US Department of Health and Human Services (HHS) released an updated shutdown contingency staffing plan, and CMS released information to stakeholders regarding claims processing and treatment of telehealth visits. CMS suggests that providers consider alerting beneficiaries with an advance notice of noncoverage and holding claims if they choose to continue to offer telehealth services. CMS has not provided assurances that providers will eventually be reimbursed for these services if Congress reinstates the flexibilities, or that patients will not be responsible for the full cost of an appointment during the lapse.

The Acute Hospital Care at Home (AHCAH) waiver also expired, and CMS noted that all hospitals with active AHCAH waivers must discharge or return all inpatients to the hospital. CMS also stopped accepting waiver requests for participation in the AHCAH initiative after September 1, 2025.

ADMINISTRATION


White House continues drug pricing push. The White House announced its first deal with a pharmaceutical company in line with President Trump’s most-favored nation (MFN) EO. As part of the deal, the administration will launch a new website, TrumpRx.gov, which should allow state Medicaid programs to purchase pharmaceuticals directly from the manufacturer at discounts, although it is unclear if these will align with MFN prices. At this time, only one drug manufacturer is participating. The details of the deal and website launch remain largely confidential at this point. Prior to the deal’s announcement, President Trump had discussed enacting a 100% tariff on certain pharmaceuticals starting October 2, 2025, but he delayed implementation to continue pursuing discussions with manufacturers on discounting pricing and making investments in the United States. We also await the release of the administration’s Global Benchmark for Efficient Drug Pricing (GLOBE) Model and Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model (CMS-5546), which may give more insight into the administration’s implementation of drug pricing initiatives.

The day before the deal announcement, Senate Health, Education, Labor, and Pensions Committee Ranking Member Sanders (I-VT) released a report criticizing the president’s approach to lowering drug prices. The report states that since President Trump took office, the prices of 688 drugs have increased by a median of 5.5%.

President Trump signs EO on pediatric cancer research. The EO directs the Make America Healthy Again Commission, HHS, the assistant to the president for science and technology, and the special advisor for artificial intelligence (AI) and crypto to develop innovative ways to use technologies such as AI to improve pediatric cancer diagnoses, treatments, cures, and prevention strategies. The EO states that the work will align with the recent “AI Action Plan” and will initially prioritize:

  • Improving data infrastructure and using AI to better select participants for clinical trials.
  • Enhancing data analysis of complex biologic systems with AI tools.
  • Improving clinical trial design, access, and outcomes by incorporating multimodal data and using AI approaches to maximize utilization of the information from clinical trials.
  • Identifying and increasing investments in pediatric cancer research, including by increasing existing federal funds for the Childhood Cancer Data Initiative at the National Cancer Institute and by encouraging the private sector to use advanced technologies, such as AI, to find cures for pediatric cancer.
  • Ensuring that AI innovation is integrated into current interoperability work to maximize the use of electronic health record and claims data that can inform private sector research and clinical trial design, while also ensuring patient privacy. The EO directs HHS to finalize interoperability standards for patient data to be used with AI to account for various types of data and to enable safe and privacy-compliant data exchanges.

The same day the EO was signed, HHS announced that it would increase funding for the Childhood Cancer Data Initiative from $50 million to $100 million. The initiative was established in the first Trump administration and aims to collect and analyze data on childhood cancer.

CMS releases Medicare Drug Price Negotiation Program final guidance. Key provisions in the newly released guidance for the third cycle of negotiations include the following:

  • ORPHAN Cures Act. The guidance outlines implementation of the ORPHAN Cures Act, which was enacted in OBBBA. The act expands the orphan drug exemption to include any orphan drug approved for one or more rare diseases. Previously, it only applied to orphan drugs that were approved to treat one rare disease. Exempted drugs do not have to participate in negotiations. The guidance also sets the approval date for a non-rare disease indication as the starting point for negotiation eligibility.
  • Medicare Advantage (MA) integration in drug selection. The guidance suggests a framework for calculating total expenditures for drugs payable under Part B by including both MA data for Part B items and services and traditional fee-for-service (FFS) Part B claims data in total expenditure calculations under Part B.
  • Treatment of vaccines for infectious diseases. CMS clarified that it will group all versions of a vaccine with the same key ingredients and manufacturer together when considering them for price negotiation, using the earliest approval date to decide if they qualify.

CMS will begin its third cycle of drug price negotiations in 2026, with the resulting maximum fair prices taking effect on January 1, 2028. CMS plans to announce 15 additional drugs covered under Part D and/or payable under Part B for potential negotiation by February 1, 2026, plus any additional drugs selected for the first cycle of renegotiation.

CMS issues guidance on Medicaid managed care coverage for immigrants. The state Medicaid director letter announces a change in how CMS interprets Medicaid managed care organization payments for services necessary for treatment of an emergency medical condition for “aliens ineligible for full Medicaid benefits.” Under this guidance, states may not contract with managed care organizations to provide such services to aliens ineligible for full Medicaid benefits. Under the updated interpretation, states have two options for providing the care:

  • FFS coverage. States may provide coverage for services necessary for treatment of an emergency medical condition to aliens ineligible for full Medicaid benefits in a FFS delivery system and claim federal financial participation (FFP) for only the actual services rendered consistent with Section 1903(v) of the Social Security Act. CMS recommends this approach because it is the simplest to implement and creates the clearest documentation of verifiable data.
  • Managed care. States may contract with prepaid inpatient health plans (PIHPs) and prepaid ambulatory health plan (PAHPs) on a non-risk basis to cover only services necessary for treatment of an emergency medical condition for aliens ineligible for full Medicaid benefits. However, FFP would only be available for the cost of the claims paid for actual services necessary for treatment of an emergency medical condition rendered, not for any other costs, including prospective payments or any administrative costs of the PIHPs or PAHPs.

CMS generally does not expect to take enforcement action with respect to implementation of this guidance before the start of the first rating period beginning at least one year following the date of publication (e.g., January 1, 2027, for states that have a rating period that operates on the calendar year).

QUICK HITS


  • ACL announces community living awards. The Administration for Community Living (ACL) will provide $60 million in new grant awards for community living programs.
  • GAO releases reports on veterans’ healthcare. The US Government Accountability Office (GAO) reports discuss the need to integrate management of medical facility and community-based care, and provide information on medical foster homes for veterans.
  • FDA releases RFI on AI-enabled devices. In the request for information (RFI), the US Food and Drug Administration (FDA) requests input on measuring and evaluating performance of AI-enabled medical devices in the real world. Comments are due December 1, 2025.
  • CMS continues to engage with states on Rural Health Transformation Program. CMS held a second webinar for program applicants, during which it stressed that the government shutdown will not extend the November 5, 2025, application deadline.

NEXT WEEK’S DIAGNOSIS


The Senate is expected to be in session next week, presumably working toward an agreement to end the shutdown, while the House announced it intends to remain in recess through October 13. The Senate will hold the following health-related hearings: