HPRA March 2024 Newsletter

March 13, 2024

2024 SNMMI Hill Day

SNMMI will be hosting our annual Hill Day on Friday, April 5, in Washington, DC. Approximately 65 SNMMI members, patients, and industry colleagues will be coming to Washington to meet with House and Senate congressional staff. Attendees will be discussing the FIND Act, the Nuclear Medicine Clarification Act, and increased federal funding for nuclear medicine.

SNMMI Meeting with CMS

On February 13, SNMMI met with CMS to discuss diagnostic radiopharmaceutical unbundling in the upcoming 2025 OPPS rule making.

Since 2008, CMS has packaged all diagnostic radiopharmaceuticals (except those with pass-through status) into payment for the associated nuclear medicine procedure. SNMMI has been concerned about the negative impacts of this policy.

In the 2024 OPPS rulemaking, CMS revisited this long-standing policy, identifying five possible alternative options and soliciting feedback. Below are the five options:

  • Option 1: Separate payment for products with per-day costs above drug packaging threshold ($135 in 2024).

  • Option 2: Establish specific per-day cost threshold (could be greater or lesser than drug packaging threshold).

  • Option 3: Restructure APCs, including adding nuclear medicine APCs for services with high-cost products.

  • Option 4: Create specific payment policies for products used in clinical trials.

  • Option 5: Adopt codes that incorporate disease state or diagnostic indication of a particular class of products.

SNMMI strongly urged CMS to support option 1. We believe option 1 is the simplest, most equitable and most appropriate approach to paying for diagnostic radiopharmaceuticals. Most importantly, option 1 removes barriers that limit patient access to important diagnostic procedures.

SNMMI along with our partners plan to continue our engagement with CMS on this important issue of diagnostic radiopharmaceutical unbundling. We will keep members updated on new information as it becomes available.

Prior Authorization Rule Update

The Biden administration finalized a rule that will simplify Medicare Advantage, Medicaid, and other government-sponsored health plans’ use of prior authorization. The rule, finalized on January 17, 2024, requires government-sponsored health plans to have a quicker response time to prior authorization requests. The rule will also require government-sponsored health plans to inform recipients of the reason for denied requests.

Key Provisions:

Starting in 2026, the affected health plans will be required to:

  • Reply to urgent requests within three days, and non-urgent requests within seven days.

  • Respond to any denied prior authorization decision regardless of the way the request was received.

In 2027, several other provisions will be required:

  • Develop application programing interfaces (APIs) that enable providers to decide if prior authorization is necessary and to automate the release of denial information. Among the APIs slated for development, the Patient Access and Provider Access APIs are the most significant.

  • The Patient Access API enhances a patient’s ability to access and view their data; this allows for a patient to have a deeper understanding of the prior authorization process and the potential impacts to their care.

  • The Provider Access API allows health plans to share information with in-network clinicians who patients visit.

Having the government finally address prior authorization is a win; however, SNMMI continues to fight inappropriate denials and reimbursement issues.

Nuclear Medicine Clarification Act

The Nuclear Medicine Clarification Act of 2023 (H.R. 6815) was introduced by Representatives Morgan Griffith (R-VA), Donald Davis (D-NC), Ben Cline (R-VA) and Deborah Ross (D-NC) on January 5, 2024.

The Bill would direct the NRC to revise its regulations on extravasations/medical event reporting according to the specifications laid out in the bill.

SNMMI is strongly opposed to this legislation. 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 plans to meet with the sponsors of this bill to discuss our opposition, along with engaging other legislators on Hill Day, about the bill’s negative impact.

Find It Early Act 2023

The Find It Early Act of 2023 (H.R. 3086) was introduced on May 5, 2023, by Representatives Rosa DeLauro (D-CT) and Brian Fitzpatrick (R-PA).

This bill would ensure all health insurance plans cover screening and diagnostic breast imaging with no out-of-pocket costs for women with dense breasts or at high risk for breast cancer.

While SNMMI strongly supports the Act, we would like to strengthen it by including molecular breast imaging (MBI) as a screening option.

SNMMI has met with staff from both House sponsors and possible sponsors from the Senate to express our opinion and educate them on the importance of MBI as a screening option. All staff members we have met with have been receptive to the additional MBI language, and we are looking forward to the inclusion of MBI in the bill.

SNMMI will continue monitoring this legislation and will keep members updated on any new issues.

2024 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 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 such as FDA, NRC and NIH, and other medical societies.

SNMMI and the Committee on Government Relations would like to congratulate Joseph Steiner, PhD, on winning this year’s 2024 Robert E. Henkin, MD, Government Relations Fellowship.

Dr. Steiner is currently a nuclear medicine physics resident at the Henry Ford Health System in Detroit, Michigan. He received his PhD in Medical Physics from Louisiana State University.

We look forward to hosting Dr. Steiner in Washington, DC, later this spring and showing him the importance of engaging in the legislative and regulatory process to support the nuclear medicine community.