HPRA December 2023 Newsletter

December 14, 2023

Centers for Medicare and Medicaid Services (CMS) Final Rule on the Hospital Outpatient Prospective Payment System (OPPS)

On November 2, 2023, CMS released the OPPS CY 2024 final rule. The proposed rule included a request for comment on unbundling radiopharmaceuticals, but the final rule did not make any changes to the bundling policy. All diagnostic radiopharmaceuticals without pass-through status will continue to be bundled in 2024.

SNMMI strongly supports unbundling of diagnostic radiopharmaceuticals and requested that CMS pay separately for diagnostic radiopharmaceuticals either at the per-day cost threshold that applies to other drugs or a higher threshold. Although CMS did not take action to unbundle radiopharmaceuticals, the agency stated that it intends to review the comments and “take them into consideration for future notice and comment rulemaking. We welcome ongoing dialogue and engagement from stakeholders regarding suggestions for potential future payment changes, including on any of the five potential approaches included in the original comment solicitation as well as any other potential solutions” (p. 101). SNMMI, along with other stakeholders, is meeting with CMS in early December to discuss these issues.

A copy of the OPPS 2024 Final Rule can be found here.

While SNMMI will continue working with CMS, it is equally important to work with Congress to pass the FIND Act. We will continue to meet with lawmakers and advocate on behalf of patients and the nuclear medicine community to accomplish that goal.

The Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2023 Update

The FIND Act (S. 1544 / H.R. 1199) would unbundle payments for certain diagnostic radiopharmaceuticals and procedures to ensure equitable access to care for patients. The bundled payments result in hospitals being disincentivized from offering particular nuclear medicine procedures. The FIND Act would close the cost gap and ensure patients have access to the most appropriate treatment options.

As of November 9, the bill has 8 Senate co-sponsors and 35 House co-sponsors. More than 125 organizations have signed a letter in support of the FIND Act. To learn more about this important legislative initiative, click here.

Recently, there has been significant movement on Capitol Hill centered around the FIND Act. Below are some highlights:

• On September 19, the FIND Act was the subject of a hearing in the House Energy and Commerce Committee’s Subcommittee on Health. Four members of Congress spoke in support of the bill.
• On October 26, 2023, SNMMI held a webinar about the FIND Act titled, “Strike While the Iron is Hot.” Speakers on the webinar included Dmitry Beyder, CNMT, MPA, Radiology Program Manager of Nuclear Medicine, PET, CT, and Patient Transport at Barnes-Jewish Hospital/Mallinckrodt Institute of Radiology.
• Topics discussed during the webinar included the reimbursement problem, how the FIND Act solves the reimbursement problem, and next steps for enacting the FIND Act. You can find a link to the webinar here.

To encourage your member of Congress to support the FIND Act and help get it passed by the 118th Congress, please send an email to your legislators by clicking here.

Nuclear Medicine Language in Department of Defense FY 24 Appropriations Bill

SNMMI successfully worked with Congress to add beneficial nuclear medicine–related language to the FY 2024 Department of Defense Appropriations Bills in both the House and the Senate. This language will be included in Congressionally Directed Medical Research Programs. These programs are funding opportunities to support service members, their families, and the general public. Below is the new language:

“The Committee encourages the Director of the Congressionally Directed Medical Research Programs to include nuclear medicine imaging and related techniques in descriptions of funding opportunities where relevant, to support early diagnosis, enhanced treatment and outcomes of active duty servicemembers and their families to drive the development of precision imaging and advanced targeted therapies while creating medical and economic efficiencies.”

The House and Senate have passed their own Department of Defense appropriations bills but have not yet reconciled differences between the bills.

SNMMI looks forward to building on the success of this new language and working toward funding for nuclear medicine research in Congressionally Directed Medical Research Programs.

Regulatory Comments

USP 823

The U.S. Pharmacopeia (USP) is currently seeking comments on proposed revisions to quality assurance standards for compounded radiopharmaceuticals used in PET imaging that appear in General Chapter 823 of the USP–NF compendia. SNMMI’s Committee on Radiopharmaceuticals, chaired by Stephen Dragotakes, is currently drafting comments to send to USP. The deadline for comment is January 31, 2024.

NRC Comment Request on Rubidium-82 Generators, Emerging Technologies, and Other Medical Use of Byproduct Material

The NRC is seeking comments on rulemaking related to rubidium generators, establishing performance-based requirements for existing and future emerging medical technologies and other medical uses of byproduct material. SNMMI will be submitting comments. To read the proposed rule or add comments, click here.

FDA Workshop on PET Drug Manufacturing

On November 13 and 14, the FDA, SNMMI, MITA, and the PET Coalition hosted a joint PET Manufacturing Workshop. The conference was well attended in person, 232, and virtually, 536. Topics covered included chemistry, manufacturing and controls, microbiology, and environmental monitoring. Pre-submitted questions from the nuclear medicine community were answered during the final day of the workshop. A follow-up article is in progress. We hope to continue this workshop in the future. 

Medicare Physician Fee Schedule Final Rule Released

On November 2, 2023, CMS released the final rule on the Medicare Physician Fee Schedule.

Next year, unless Congress passes legislation, physician payments will be cut. The 2024 Medicare conversion factor will be decreased by 3.39 percent from $33.8872 to $32.7375. For years, CMS has proposed a lowered physician payment. SNMMI opposes these cuts to Medicare and is working with other stakeholders and Congress to help pass legislation to avert these cuts. Lower physician payment impacts patient access to crucial nuclear medicine imaging and therapeutic procedures.

2024 Robert E. Henkin, MD, Government Relations Fellowship

Applications are currently open for the 2024 Robert E. Henkin, MD, Government Relations Fellowship. Each year, the Henkin Fellowship offers the opportunity for an early career professional to visit Washington, DC, and experience direct personal exposure to 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 by visiting Congress, federal agencies like FDA, NRC and NIH, and other medical societies.

The Fellow receives a $1,000 stipend, in addition to all-expense paid travel to the Washington, DC, area.
The deadline to apply for the 2024 Robert E. Henkin, MD, Fellowship is January 2, 2024.

To learn more about the fellowship and apply, click here.