HPRA Summer 2025 Newsletter
CMS Releases 2026 Medicare Physician Fee Schedule and the Hospital
Outpatient Prospective Payment System Proposed Rules
Recently, the Centers for
Medicare & Medicaid Services (CMS) released its 2026 proposed rules for
the Medicare Physician Fee Schedule (MPFS) and the Hospital Outpatient Prospective Payment System
(OPPS). SNMMI is reviewing all
provisions and will provide a more detailed analysis in the near future, as
well as submitting comments to CMS.
Key provisions that will impact
nuclear medicine from both proposed rules are summarized below; the full
explanation is available HERE.
- For SNMMI-prepared Medicare Physician Fee
Schedule Chart click here.
- For SNMMI-prepared HOPPS Rate-APC
Chart click here.
A fact sheet on the final rules
may be found here for MPFS and here for OPPS.
Hospital Outpatient Prospective Payment System (OPPS) Key Nuclear
Medicine Updates
- Payment for Diagnostic Radiopharmaceuticals
- CMS will continue using mean unit cost (MUC)
as the payment method for separately payable diagnostic
radiopharmaceuticals with per-day costs >$655 (threshold proposed for
CY 2026).
- ASP (Average Sales Price) reporting remains
voluntary under OPPS but is encouraged. CMS seeks input on
challenges/barriers to ASP reporting.
- Packaging Threshold Increase
- Proposed increase from $630 to $655 per day
for radiopharmaceutical packaging threshold for CY 2026, adjusted for
inflation (based on the Producer Price Index).
- CMS indicates that 30 diagnostic
radiopharmaceuticals would qualify for separate payment under the
increased threshold.
- New Add-On Payment for Tc-99m
- A $10 add-on payment will begin in 2026 for
Tc-99m doses derived from domestically produced Mo-99, to support U.S.
supply chain and national security.
- This replaces the old add-on, which rewarded
production without highly enriched uranium (HEU).
- The add-on requires that ≥50% of Mo-99
come from U.S. sources; new HCPCS code C917X will be created for billing.
During the previous year, SNMMI
met with Political and Career Leadership at CMS. We will continue our efforts
to encourage CMS to reimburse radiopharmaceuticals using ASP data instead of
MUC.
Medicare Physician Fee Schedule (MPFS) Key Nuclear Medicine Updates
- Conversion Factor Update for 2026
- CMS proposes two conversion factors:
- $33.5875 for qualifying APM participants (QPs) 3.83% increase.
- $33.4209 for non-QPs 3.62% increase.
- Determination of relative value units
- All PET and PET/CT CPT codes (technical and
global) remain at contractor price, consistent with SNMMI advocacy.
- New Efficiency Adjustment Proposal: CMS proposes a 2.5% reduction in work
RVUs and physician time for non-time-based codes (e.g., procedural
services), applied every 3 years.
- Site-of-Service Payment Differential: CMS proposes changes to indirect
practice expense RVUs based on practice ownership and site of service.
This would reduce facility-based practice
expense RVUs by 7% and increase non-facility-based
RVUs by 4%.
- Malpractice RVU Update: CMS will use updated 2026 malpractice
premium data from state insurance filings to revise malpractice RVUs.
- Software-as-a-Service Reimbursement: CMS is requesting feedback on how to
price services using software-as-a-service models and whether OPPS rates
can be used as benchmarks.
Quality
Programs and MIPS
- MIPS Performance Threshold
- The 75-point threshold to avoid penalties
remains through the 2026 2028 performance years (2028 2030 MIPS payment
years).
- New MIPS Value Pathways
- CMS proposes six new MIPS Value Pathways,
including a focus on diagnostic and interventional radiology.
- CMS will also update measures impacting MIPS
performance pathways.
2025 Annual Meeting Advocacy Update
The SNMMI Health Policy
and Regulatory Affairs (HPRA) team is celebrating a successful 2025 Annual
Meeting. Both the Government Relations Committee and the Committee on
Radiopharmaceuticals held in-person meetings to discuss important regulatory
and legislative issues impacting the nuclear medicine community. The topics
covered included updates on the reconciliation and budget process currently
underway in Congress, impacts of radiopharmaceutical tariffs on patients,
opposition to the Nuclear Medicine Clarification Act, and the recent Executive
Order impacting the NRC. The Technologist Advocacy Committee met earlier in the
week to discuss the committee s goals for the upcoming year, consider changes
to the Technologist Advocacy Group (TAG), and review current licensure and
regulatory efforts taking place at the state level.
Health Policy and
Regulatory Affairs staff also organized multiple continuing education sessions
during the meeting, including Regulatory Changes in Washington Impacting
Nuclear Medicine, Medicare s New Payment Policy for Diagnostic RPs,
and Technologist Advocacy Why Grassroots Action Matters to You. These
sessions had excellent turnout and received positive feedback. We are thankful
to all our expert speakers and moderators for their hard work, which made these sessions a success.
Thank you to all the
members who attended the committee meetings and continuing education sessions.
We look forward to taking the ideas and feedback received at this meeting and
turning them into advocacy action items to help represent the field of nuclear
medicine.
SNMMI Applauds the World Health Organization (WHO) for Passing a Resolution
Titled Strengthening Medical Imaging Capacity.
SNMMI applauds the 78th
World Health Assembly (WHA78) for approving the World Health Organization (WHO)
Executive Board s resolution EB156(17), Strengthening Medical Imaging Capacity. This
resolution highlights the vital role of medical imaging in delivering timely,
accurate diagnoses and effective treatment for many health conditions. In the
field of nuclear medicine, we have seen medical imaging pave the way for
breakthroughs in the diagnosis and treatment of cancer and rare diseases.
Medical imaging is a pillar
of modern healthcare. It provides physicians with a roadmap for treatment,
directs clinical decision making, and monitors treatment outcomes. We commend
this resolution s effort to address the inequalities that impact
our global partners. As stated in the resolution, these inequalities
disproportionately affect low-resource and remote areas. The 18 steps laid out
in the resolution provide strong direction on how the WHO
can expand access to imaging services in underserved areas.
We applaud the inclusion of
theranostics and the recognition of its vital
role now and in the future in the diagnosis and treatment of disease. The
future of this new field is bright, with breakthroughs occurring rapidly.
The document also urges
Member States to consider integrating technological advances, such as
telehealth, teleradiology, clinical decision support, artificial intelligence
and specific software applications, into radiology information systems for
patient records, in compliance with applicable international standards and
protocols for medical imaging, including ethical aspects, security and
confidentiality of data.
The resolution was officially
approved at the World Health Assembly during the 78th session in Geneva,
Switzerland, from May 19 to May 27.
More information about the
WHO resolution is available here.
President s Executive Order on NRC Update
On May 23,
2025, the White House issued an executive order titled Ordering the Reform of
the Nuclear Regulatory Commission. The order calls for a major reevaluation of
the as low as reasonably achievable (ALARA) principle and the
linear-non-threshold (LNT) model, stating that these models lack sound
scientific basis and result in irrational outcomes, such as requiring
nuclear facilities to mitigate radiation levels below what naturally occurs in
the environment. The directive instructs the Nuclear Regulatory Commission
(NRC) to reconsider its reliance on these frameworks.
While the executive
order appears to focus primarily on the nuclear power sector, the implications
for the broader radiation safety community, including nuclear medicine, remain
unclear. ALARA has long served as a cornerstone of radiation protection,
embedded in federal and state regulations and widely adopted across healthcare,
energy, and industrial settings. It is also the prevailing standard of care for
minimizing patient exposure during medical procedures.
SNMMI is
closely monitoring developments to understand how these proposed regulatory
shifts could affect clinical practice and safety protocols.
SNMMI Submitted Comments to the Department of Commerce in Response to a
Notice of Request for Public Comments on Section 232 National Security
Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients
Recently,
SNMMI submitted comments to the Department of Commerce in
response to a Notice of Request for Public Comments on Section 232 National
Security Investigation of Imports of Pharmaceuticals and Pharmaceutical
Ingredients. Given the delicate nature of the current radiopharmaceutical
supply chain, SNMMI believes that imposing tariffs on medical isotopes would
increase costs for providers, impact patient access, and reduce access to
nuclear medicine procedures.
In 2024,
the U.S. radiopharmaceutical market was valued at approximately $2.43 billion,
and it is projected to double by 2033, reaching $4.86 billion with a compound
annual growth rate of 8%. This surge in demand is driven by the expanding use
of nuclear medicine. In the United States, approximately 20 million diagnostic
scans are performed annually, and approximately 2,830 hospitals provide these
services to Medicare beneficiaries.
The U.S.
consumes more than half of the global Tc-99m supply and uses more than 30 other
medical isotopes sourced exclusively from abroad. These isotopes are made into
radiopharmaceuticals by American companies in Ohio, Wisconsin, Florida, and
other states, then quickly distributed across the country to facilities
performing nuclear medicine procedures on patients.
The
radiopharmaceutical supply chain is especially fragile due to the short shelf
life of isotopes and the limited number of suppliers. Providers have benefited
from the current speed and steadiness of established radiopharmaceutical supply
chains. Domestic radiopharmaceutical suppliers, who receive isotopes from
abroad, would be impacted by price changes and uncertainty caused by tariffs.
This drastic change in supply prices will impact providers and patients alike.
In the
future, we hope to create domestic supplies of medical isotopes for
radiopharmaceutical production; however, building commercial-scale facilities
for Mo-99 and other medical isotopes in the U.S. will require approximately 10
to 15 years and significant investment. With assistance from the Department of
Energy, companies are making strides in the domestic production of medical
isotopes such as actinium-225, but our domestic capacity to produce other medical
isotopes remains limited due to high costs for facility development and aging
existing infrastructure.
SNMMI
looks forward to working with the Administration on developing policies that
would reduce regulatory burdens, streamline licensing, and create financial
incentives to foster a durable and resilient environment for innovation and
business to thrive in the United States.
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.
SNMMI and
the Committee on Government Relations would like to congratulate Vrushab Gowda,
MD, JD, on winning this year s 2025 Robert E. Henkin, MD, Government Relations
Fellowship.
Dr. Gowda
is currently a resident physician at the Massachusetts General Hospital in Boston,
Massachusetts. He holds a law degree from Harvard Law School.
We look
forward to hosting Dr. Gowda later this summer and showing him the importance
of engaging in the legislative and regulatory process to support the nuclear
medicine community.