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HPRA Fall 2025 Newsletter

Government Shutdown Update

Congress was unable to reach a bipartisan consensus on extending government funding beyond September 30, 2025. As a result, the federal government shut down at 12:01 a.m. on Wednesday, October 1, 2025, and as of October 16, an agreement to provide the funding to reopen the government has yet to be reached. The last major government shutdown occurred in 2019.

Not all federal functions cease during lapses in government funding. Activities supported by mandatory appropriations such as federal health programs like Medicare and Medicaid will continue, as will essential services related to national security and public safety. However, other normal government functions may be paused, delayed, or slowed as staff are furloughed or duties change per contingency plans put into place by federal agencies.

The agencies have been directed to prepare not only for furloughs, but also for potential reductions in force permanent layoffs.

Below is a short summary of the impact of the shutdown on healthcare-related agencies.

FDA Contingency Plan (FY 2026)

The Food and Drug Administration (FDA) retained 86% of its staff, thanks in large part to user-fee funding collected from entities in industries under FDA jurisdiction. Although the FDA can use previously collected user fees to support continued operations, it cannot collect any new user fees.

Staffing

 Approximately 13,872 employees will continue to work. Of these, 66% are exempt (funded by user fees or other ongoing sources), while 19% are excepted staff handling critical functions.

Activities Continuing

User fees will allow the FDA to maintain

  •        reviews and approvals of medical products
  •        oversight of tobacco products
  •        issuance of certain guidance
  •        reviews of requests for clinical research

The agency will also carry out emergency functions, such as recalls, outbreak response, import safety reviews, for-cause inspections, and criminal enforcement actions.

Activities Paused

  •        Acceptance of new drug, biologic, biosimilar, device, or animal drug applications that require user-fee payments
  •        Hiring, staff development, and laboratory investments in areas without carryover funding
  •        Oversight of unapproved and compounded drugs, unless tied to imminent threats to health or safety
  •        Pre-market reviews of novel animal food ingredients and broader food safety initiatives, leaving only emergency surveillance and responses

 

CMS Contingency Plan (FY 2026)

The Centers for Medicare & Medicaid Services (CMS) core entitlement programs will proceed largely uninterrupted:

       Medicare: Operations will continue during the shutdown, although claims will be held for 15 days.

CMS shared:

We've instructed the MACs to hold all claims with dates of service on or after 10/1/25. This is standard at the start of each quarter to allow for validation of quarterly system releases. The hold also helps prevent the need to reprocess large volumes of claims should Congress act after the statutory expiration date. We expect this to have minimal impact on providers, as the 14-day payment floor still applies. Claims for services not related to the extenders are anticipated to be released and paid immediately following the 14-day payment floor (which includes the 10-day hold). Decisions on claims tied to the extenders remain pending until the status of the legislation is determined.

As of 10/16/25:

In light of the continuing government shutdown, CMS will continue to process and pay held claims in a timely manner with the exception of select claims for services impacted by the expired Medicare legislative payment provisions passed under the Full-Year Continuing Appropriations and Extensions Act, 2025. To date, no payments have been delayed as statute already requires all claims to be held for a minimum of fourteen days, and this recent hold is consistent with that statutory requirement. Providers may continue to submit claims accordingly.

       Medicaid: CMS has sufficient funding to cover Medicaid for the first quarter of FY 2026 (Oct Dec 2025) due to the advance appropriation included in the Full-Year Continuing Appropriations and Extensions Act, 2025. Payments to states for CHIP will also continue.

       Marketplace: Federal Marketplace activities, such as eligibility verification, will be supported by carryover user fees.

Staffing

CMS has retained 3,311 staff (53% of its workforce), including 3,105 exempt employees funded through nondiscretionary sources (such as user fees and mandatory programs) and 206 excepted staff who perform life-safety or property-protection functions. An additional 84 commissioned corps members will continue working.

Activities Impacted

  •        CMS will limit facility surveys to the most serious complaints.
  •        Policy and rulemaking will be delayed, and oversight of contractors such as Medicare Administrative Contractors, call centers, and IT vendors will be scaled back.
  •        Outreach, education, and casework functions will largely be suspended.

 

NIH Contingency Plan (FY 2026)

Staffing

The National Institutes of Health (NIH) has retained 4,477 staff (24.54% of its workforce). Only five staff are exempt, with 4,472 designated excepted.

Activities Continuing

  •        NIH Clinical Center patient care
  •        Safety of animals and ongoing experiments
  •        Maintenance of infrastructure (labs, IT, property)
  •        Critical systems (clinical records, networks) needed for patient care and clinical trials

Activities Paused

  •        Peer review meetings, advisory councils, and issuance of new grants or awards have been paused.
  •        Admission of new patients (unless medically necessary) and initiation of new clinical protocols will generally cease.
  •        Basic and translational research, training programs, scientific meetings, travel, most administrative functions, and many veterinary services will be curtailed or halted.

 

SNMMI will continue to monitor the situation and provide updates to our members. We remain hopeful that lawmakers will come to the negotiating table and pass a bipartisan funding measure to reopen the government immediately.

 

SNMMI Applauds the Senate and House for Including Nuclear Medicine Research Language in Appropriations Reports for L-HHS and DoD

On July 31, the Senate Appropriations Committee released FY 2026 reports for Labor, Health and Human Services (L-HHS) and the Department of Defense (DoD). The House of Representatives followed the Senate's lead in September by introducing its own FY 2026 reports for L-HHS and the DoD.

Both chambers'  L-HHS reports include language from SNMMI encouraging the National Cancer Institute (NCI) to support research that utilizes and promotes theranostics, where appropriate, to provide early, accurate, and effective cancer diagnosis and treatment.

As a result of SNMMI's advocacy, the Senate's DoD report includes neuroendocrine tumors (NETs) as an allowable research area in the Congressionally Directed Medical Research Programs (CDMRP) Peer-Reviewed Cancer Research Program.

The CDMRP was created in 1992 by Congress to foster novel approaches to biomedical research that benefit active-duty service members, their families, and the general public. These programs fund innovative research related to several cancers and diseases.

Nuclear medicine plays a pivotal role in diagnosing and treating NETs, the second most common type of gastrointestinal cancer. Compared with conventional imaging, nuclear medicine imaging offers greater sensitivity and allows for more accurate localization and precise detection, making it an excellent option for both diagnosis and treatment.

These major wins for the nuclear medicine field would not have been possible without the letter-writing, advocacy and persistence of SNMMI's membership.

SNMMI will continue to monitor the current budget process and urges lawmakers to work together to pass a full FY 2026 budget.

The full language for both reports is shown below.

Labor, Health and Human Services (L-HHS) Theranostics Language

Theranostics is a nuclear medicine technique that combines diagnostic imaging and targeted radiopharmaceutical therapies to precisely identify and treat diseases like cancer. This cutting-edge technology uses diagnostic imaging to identify and target cancer cells; if such cells are present, radiopharmaceutical therapies are injected intravenously and bind to the targeted cancer cells to deliver localized doses of radiation to the tumor. Theranostics are an innovative, precision medicine technique that allows for personalized treatment of cancers such as thyroid cancer, prostate cancer, and neuroendocrine tumors while sparing healthy tissue around the tumor. Theranostics show huge potential to advance the battle against cancer; a disease that remains a formidable challenge in medicine and has claimed a significant number of lives nationwide. The Committee encourages NCI to support research that utilizes and promotes theranostics, where appropriate, to provide early, accurate, and effective cancer diagnosis and treatment.

Defense - Congressionally Directed Medical Research Program s (CDMRP) Peer Reviewed Cancer Research Program (PRCRP) Neuroendocrine Tumors (NETs)

The Committee recommends $130,000,000 for the peer-reviewed cancer research program. The funds provided in the peer-reviewed cancer research program are directed to be used to conduct research in the following areas: bladder cancer; blood cancers; brain cancer; colorectal cancer; endometrial cancer; esophageal cancer; germ cell cancers; glioblastoma; kidney cancer; liver cancer; lung cancer; lymphoma; mesothelioma; metastatic cancer; myeloma; neuroblastoma; neuroendocrine tumors; pediatric brain tumors; pediatric, adolescent, and young adult cancers; sarcoma; stomach cancer; and thyroid cancer.

SNMMI Holds Meeting with CMS Leadership and Submits Comments on the Medicare Physician Fee Schedule and Hospital Outpatient Prospective Payment System

In September, SNMMI submitted comments on the Centers for Medicare & Medicaid Services (CMS) CY 2026 proposed rules for the Medicare Physician Fee Schedule (MPFS) and the Hospital Outpatient Prospective Payment System (OPPS). You can read SNMMI's full summary of the MPFS and OPPS proposed rule here. 

The Society worked with members of the Coding and Reimbursement Committee to develop our comment letters. Below is a list of topics covered in SNMMI's comment documents. You can read the full comment letters on the SNMMI website here. 

OPPS

Diagnostic Radiopharmaceutical Packaging Threshold

  •        SNMMI supports CMS s continued separate payment policy for high-cost diagnostic radiopharmaceuticals but urges refinement of the packaging methodology to use radiopharmaceutical-specific cost data rather than general drug indices.

Payment Methodology for Proposed Separately Payable Diagnostic Radiopharmaceuticals Mean Unit Cost (MUC) vs. Average Sales Price (ASP)

  •        SNMMI opposes CMS s reliance on MUC as a payment basis and urges a transition to the ASP methodology to more accurately reflect true acquisition costs and ensure consistent reimbursement.

Reductions in Payment for Selected Nuclear Medicine Current Procedural Terminology (CPT) Codes

  •        SNMMI expresses concern over payment reductions for several nuclear medicine CPT codes and requests greater transparency, rationale disclosure, and phased implementation to prevent access disruptions.

Add-on Payment for Technetium-99m (Tc-99m) Derived from Domestically Produced Molybdenum-99 (Mo-99)

  •        SNMMI supports new the $10 per-dose add-on payment for domestically produced Mo-99 and urges clear implementation guidance, periodic rate review, and potential expansion to other isotopes like Xe-133 and I-131.

Solicitation on Software as a Service (SaaS)

  •        SNMMI encourages CMS to adopt an evidence-based, flexible payment framework for SaaS and AI-enabled technologies that reflect clinical value while ensuring fair, stable reimbursement across care settings.

Drug Acquisition Cost Survey

  •        SNMMI urges CMS to exclude radiopharmaceuticals from the OPPS Drug Acquisition Cost Survey due to their specialized cost structure and low-volume use, recommending alternative targeted data sources instead.

Copayment Considerations for Diagnostic Radiopharmaceuticals

  •        SNMMI requests clarification on when beneficiary copayments apply to diagnostic radiopharmaceuticals, seeking confirmation that pass-through products below the cost threshold should not trigger a copayment.

 

MFPS

Conversion Factor Update

  •        SNMMI supports the statutory conversion factor increase for 2026 but stresses that persistent underpayment threatens practice stability and urges CMS and Congress to pursue long-term reforms tying physician updates to inflation and the Medicare Economic Index.

Evaluation and Management (E/M) Visits

  •        SNMMI urges CMS to correct the overestimated 38% utilization assumption for HCPCS code G2211, which led to unnecessary cuts in the conversion factor, and to adjust the 2026 rate prospectively using actual 2024 claims data.

Transition Toward dCQMs for CMS Programs

  •        SNMMI endorses CMS s shift to digital clinical quality measures (dCQMs) but highlights the absence of nuclear medicine specific data standards and calls for collaboration to incorporate specialty-specific ontologies and interoperability improvements.

 

In August, SNMMI and a coalition of organizations representing the nuclear medicine field, met with CMS to encourage them to use average sales price (ASP) rather than mean unit cost (MUC) when determining reimbursement rates. Currently, diagnostic radiopharmaceuticals are reimbursed based on the mean unit cost (MUC). However, SNMMI believes that MUC data does not accurately reflect payment for radiopharmaceuticals. MUC is not designed to reflect the actual cost of diagnostic radiopharmaceuticals; the data can vary dramatically from year to year.

SNMMI has urged CMS to use average sales price (ASP) data as an alternative to MUC when determining reimbursement rates for radiopharmaceuticals. ASP, derived from sales data, more accurately reflects the actual cost of diagnostic radiopharmaceuticals to hospitals. Reporting ASP data would better align diagnostic nuclear medicine products with other drugs and help prevent dramatic mid-year changes in payment for products coming off pass-through.

SNMMI will continue our advocacy efforts in the future to make sure providers can provide the highest quality diagnostic imaging care for patients at a consistent price.

2025 Robert E. Henkin, MD, Government Relations Fellowship Winner

Each year, the Henkin Fellowship awards the opportunity for an early career professional to visit Washington, DC, and receive direct personal exposure to the government relations activities of the SNMMI. Throughout the week, the Fellow learns first-hand how the federal legislative and regulatory process impacts nuclear medicine and molecular imaging through visiting Congress, federal agencies such as FDA, NRC and NIH, and other medical societies.

This year's Henkin Fellow is Vrushab Gowda, MD, JD. Dr. Gowda is currently a resident physician at the Massachusetts General Hospital in Boston, Massachusetts. He holds a law degree from Harvard Law School.

SNMMI Health Policy and Regulatory Affairs (HPRA) team hosted Dr. Gowda in Washington, DC between September 15th-19th. The week began with a day of presentations from leadership on the operations, strategic plan, and history of SNMMI. During Dr. Gowda s visit, he advocated for the nuclear medicine field on Capitol Hill meeting with his Senator and Congressman from Massachusetts. Dr. Gowda also met with federal agency staff from the NIH, FDA, DOE, and NRC to learn about how their work impacts nuclear medicine. The week included meetings with industry and partner organizations to discuss their advocacy efforts and overlap with SNMMI s strategic plan.

If you are interested in applying for the 2026 Robert E. Henkin Fellowship, the application window will be open between October 17th, 2025, and January 2nd, 2026. You can apply at the following link.

SNMMI, ACR, ASTRO and AAPM Oppose the Reintroduction of the Nuclear Medicine Clarification Act

On April 1, 2025, the Nuclear Medicine Clarification Act of 2025 (H.R. 2541) was reintroduced in the House of Representatives by Representative Donald Davis (NC-1). This bill is identical to the 2023 Nuclear Medicine Clarification Act.

SNMMI, ACR, ASTRO, and AAPM are strongly opposed to this legislation. The legislation preempts the long-standing jurisdiction of the Nuclear Regulatory Commission (NRC) regarding regulations related to nuclear medicine. The bill requires the Commission to impose, in our view, arbitrary, unreasonable extravasation reporting requirements without a clear, clinical link to patient safety or a credible scientific basis.

The NRC is currently in the middle of rulemaking on this topic. This is a complex clinical issue that is under the purview of regulatory experts at the NRC and should remain there.

SNMMI, along with ACR, ASTRO, and AAPM, sent a letter to all members of the Energy and Commerce Committee to express our opposition to the Act. You can read the full letter here.

We will continue to monitor this troubling legislation and provide updates when necessary.