The U.S. Facilities for Medicare and Medicaid Companies (CMS) proposed a brand new reimbursement plan July 10 for diagnostic PET scans that would supply separate funds for radiopharmaceuticals, in addition to an additional fee for hospitals once they use domestically produced technetium-99m (Tc-99m).
At present, the CMS bundles Medicare funds for PET radiotracers for diagnosing illness as a part of the packaged price of imaging procedures in hospital outpatient settings. Nonetheless, its proposed rule for 2025 features a refinement that can “enhance the accuracy of the general fee quantities by paying individually for any diagnostic radiopharmaceutical with a per day price larger than $630 and eradicating their prices from the fee quantities for the nuclear medication checks,” the CMS mentioned.
The brand new plan would doubtless improve affected person entry to those necessary imaging research.
In an interview with AuntMinnie.com in response to the information, Society for Nuclear Drugs and Molecular Imaging (SNMMI) President Cathy Cutler, PhD, mentioned that beneath the present fee system, hospitals merely aren’t reimbursed at ranges that cowl what it prices to make diagnostic PET radiopharmaceuticals.
“As you possibly can think about, should you’re working a hospital or enterprise, you possibly can’t actually afford to make a drug and never get reimbursed for what it prices you,” she mentioned.
The rule change comes forward of any motion on the Facilitating Revolutionary Nuclear Diagnostic (FIND) Act and will mirror a transfer to maintain abreast of sharply growing wants for PET tracers utilized in Alzheimer’s illness and prostate most cancers, Cutler advised. Importantly, the proposed rule ought to finally improve entry for sufferers to those essential nuclear medication exams, as a rise in fee for the PET brokers will result in extra hospitals providing the checks, she added.
Medical know-how commerce affiliation Superior Medical Expertise Affiliation (AdvaMed) additionally mentioned the CMS proposal is welcome information.
“Reaching separate fee for diagnostic radiopharmaceuticals continues to be a high precedence for AdvaMed – thousands and thousands of sufferers and their members of the family applaud this constructive step in the fitting path,” mentioned Pat Hope, govt director of AdvaMed’s imaging division, in a request for a remark.
The affiliation will probably be working with all stakeholders in assist of the proposal earlier than it’s finalized in the beginning in 2025, Hope added.
Add-on fee
As well as, the proposed rule contains an add-on fee for domestically produced Tc-99m, probably the most broadly used PET radiotracers, which the CMS mentioned addresses a fee inequity amongst outpatient hospital suppliers.
Traditionally, overseas molybdenum-99 (Mo-99) manufacturing has been backed by overseas governments, leading to costs under the true price of manufacturing. These artificially low, overseas government-subsidized costs have created a disincentive for home investments in Mo-99 manufacturing infrastructure and a barrier to entry for brand spanking new producers, the CMS mentioned.
“We suggest to handle this fee inequity on this rule by establishing a brand new add-on fee of $10 per dose for radiopharmaceuticals that use Tc-99m derived from domestically produced Mo-99 beginning on January 1, 2026,” the CMS mentioned.
Mo-99 is the supply materials for Tc-99m, which is utilized in an estimated 40,000 nuclear medication diagnostic exams every day within the U.S.
The CMS mentioned it believes the $10 add-on fee for domestically produced Tc-99m will assist cowl the anticipated greater price of the merchandise.
The publication of the proposed rule (CMS 1809-P) opens a 60-day remark interval, which can finish on September 9, 2024. The ultimate rule will then be issued in early November, in line with the CMS.
