Centers for Medicare
and Medicaid
Services (CMS)
RESTON, VA - Reimbursement of molecular imaging and therapies-leading to the early detection and diagnosis of many life-threatening diseases-remains an urgent and critical need as consumers face ever-increasing healthcare costs. The Centers for Medicare and Medicaid Services (CMS) needs to provide fair and adequate reimbursement for effective diagnostic techniques and life-saving medical therapies--yet currently, diagnostic radiopharmaceuticals are not adequately reimbursed. To address this pressing problem, SNM has issued proposed recommendations and rationale for reforming radiopharmaceutical reimbursement under Medicare.
Despite statutory language in the Social Security Act clearly defining radiopharmaceuticals as "specified covered outpatient drugs," CMS recently reclassified diagnostic radiopharmaceuticals as "supplies" instead of "drugs." This distinction has bundled payment for diagnostic radiopharmaceuticals into the payment for nuclear medicine procedures, thus threatening Medicare and other patient access to these critical diagnostic drugs.
"Treatments exist today that can radically improve the prognosis for patients suffering from many devastating diseases, and yet reimbursement by CMS for these drugs is sometimes less than half the actual cost of producing them," said 2008-09 SNM President Robert W. Atcher, Ph.D., M.B.A. "As we develop new therapeutic radiopharmaceuticals that have the potential to dramatically change disease outcomes, we need to ensure that they will be adequately reimbursed in order to be effectively utilized."
To address this issue and to ensure that Medicare beneficiaries continue to have access to diagnostic radiopharmaceuticals, SNM has issued the following recommendations:
1. All radiopharmaceuticals should be recognized and treated as drugs, not supplies.
2. CMS should continue to reimburse radiopharmaceuticals at charges reduced to cost in 2008 while working with the nuclear medicine industry (nuclear pharmacies and manufacturers) to develop standard payment methodology based on the average radiopharmaceutical invoice price at the distributor or nuclear pharmacy level (patterned after the average sales price model for drugs).
3. All radiopharmaceuticals should qualify for the same bundling threshold in 2008 ($60.00) as all other drugs.
4. CMS should accept and utilize external data sources to identify and appropriately reimburse radiopharmaceuticals under HOPPS, as the agency does for all other drugs. The most accurate sources of radiopharmaceutical cost data are nuclear pharmacies and manufacturers.
