SNM responds to CMS reclassification of diagnostic radiopharmaceuticals

Tag : diagnostic supplies
Despite statutory language in the Social Security Act definingradiopharmaceuticals as "specified covered outpatientdrugs," the Centers for Medicare & Medicaid Services (CMS)recently reclassified diagnostic radiopharmaceuticals as suppliesinstead of drugs. In response, the Society of Nuclear Medicine(SNM) has proposed recommendations for reformingradiopharmaceutical reimbursement under Medicare.

SNM said the new CMS distinction has bundled payment for diagnosticradiopharmaceuticals into the payment for nuclear medicineprocedures, thus threatening Medicare and other patient access tothe diagnostic drugs.

“Treatments exist today that can radically improve theprognosis for patients suffering from many devastating diseases,and yet reimbursement by CMS for these drugs is sometimes less thanhalf the actual cost of producing them,” said 2008-09 SNMPresident Robert W. Atcher, PhD. “As we develop newtherapeutic radiopharmaceuticals that have the potential todramatically change disease outcomes, we need to ensure that theywill be adequately reimbursed in order to be effectivelyutilized.”

To address the issue and ensure that CMS beneficiaries have accessto diagnostic radiopharmaceuticals, SNM has issued the followingrecommendations:
1. All radiopharmaceuticals should be recognized and treated asdrugs, not supplies.

2. CMS should continue to reimburse radiopharmaceuticals at chargesreduced to cost in 2008, while working with the nuclear medicineindustry (pharmacies and manufacturers) to develop standard paymentmethodology based on the average radiopharmaceutical invoice priceat the distributor or nuclear pharmacy level (patterned after theaverage sales price model for drugs).

3. All radiopharmaceuticals should qualify for the same bundlingthreshold in 2008 ($60.00) as all other drugs.

4. CMS should accept and utilize external data sources to identifyand appropriately reimburse radiopharmaceuticals under HOPPS, asthe agency does for all other drugs. The most accurate sources ofradiopharmaceutical cost data are nuclear pharmacies andmanufacturers, according to SNM.
SNM said the imaging techniques are essential to the management ofserious diseases, including heart disease and cancer, as theyprovide specific information about physiologic, metabolic and otherfunctional activities in the body or its pathology and allow foreffective targeted therapy.