The proposed coverage decision goes on to limit payment for the scan solely to use in clinical trials that are intended to demonstrate the value of the test in some tangible measure of clinical utility — or to enrich a patient population for development of a potential therapeutic.
The current and recently proposed reimbursement policies indeed pose a great challenge to innovation and medicine's drive toward personalize health care which includes the use of more specific diagnostic radiopharmaceutical compounds. If given the choice, most of us would likely want all radiopharmaceuticals to be paid as specified covered outpatient drugs (SCOD) and in the same fashion as most other drugs in addition to a fair payment rate for the procedure because we know that performing the least costly test often does not provide the physician or the patient with the information needed to arrive at the most appropriate care outcome, and negatively affects specialty and tertiary care centers which see higher volumes of rarer diseases.
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At the end of the day, the federal government makes it clear that it intends to limit (and possibly eliminate) reimbursement for new technologies (drugs and devices) upon FDA approval if that technology does not meet an alternate set of clinical data requirements designed to also satisfy the government as a health care purchaser (CMS). Commenting on the proposed rules and regulations is always a great way to make your voice heard and to get your position on record. If you want to submit a comment on the proposed 2014 rule, post your comment at www.regulations.gov. Conversely, true federal affairs and coalition strategies are needed to preserve a successful pathway toward nuclear medicine innovation. The comment deadline is close of business September 6, 2014.
Peter J. Webner is vice president of business and clinical development at Zevacor Molecular, a healthcare firm that manufactures PET and SPECT Radiopharmaceuticals.
Tamar Thompson is a health policy and reimbursement strategist with an extensive background in reimbursement strategy for cutting-edge molecular diagnostic and therapeutic treatments options. She's currently vice president at ADVI.
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