Reps. Peters and Rush Urge CMS for an OPPS Regulatory Fix

April 12, 2021

Last week, Reps. Scott Peters (D-CA 52nd District) and Bobby Rush (D-IL 1st District) sent a letter to the Centers for Medicare & Medicaid Services (CMS) Acting Administrator Elizabeth Ritcher. The letter addressed their concerns regarding the current reimbursement methodology associated with diagnostic radiopharmaceuticals under the Medicare Hospital Outpatient Prospective Payment System (OPPS). The flawed reimbursement policy utilized by CMS threatens patient access to these cutting-edge innovations by creating a disincentive for hospitals to use the most appropriate diagnostic drugs.

Today, more than 20 million Americans benefit from nuclear medicine procedures annually. Diagnostic radiopharmaceuticals are the drugs necessary for all nuclear medicine imaging studies to diagnose and determine the severity of disease. Some of these exciting new nuclear medicine drugs provide precision imaging for hard-to-diagnose diseases such as Alzheimer’s disease, Parkinson’s disease, cardiovascular disease, and prostate, breast, and neuroendocrine cancers. However, since 2008, in the hospital setting, CMS has treated diagnostic radiopharmaceuticals as a supply “ancillary to” the procedure and — after a three year pass-through payment period — has “policy packaged” the diagnostic radiopharmaceutical cost into the procedure amounts in the Ambulatory Payment Classification (APCs).

The letter continued, "Automatically packaging newer, often lower volume, higher cost precision diagnostic radiopharmaceuticals into procedure APCs fundamentally does not work." The cost of these precision diagnostic radiopharmaceuticals often significantly exceeds the cost of the packaged procedure reimbursement. The net result is that beneficiaries do not always have access to innovative diagnostic radiopharmaceuticals at readily accessible healthcare locations.

SNMMI, the Medical Imaging & Technology Alliance (MITA) and the Council on Radionuclides and Radiopharmaceuticals, Inc. (CORAR) have repeatedly communicated to CMS over the past twelve years that the policy packaging of diagnostic radiopharmaceuticals could negatively affect patient access care. Although a number of solutions have been proposed, CMS has not made any changes in reimbursement policy for diagnostic radiopharmaceuticals under the OPPS. In fact, in December 2020, CMS issued its Final Rule for 2021, rejecting the recommendations of its Advisory Committee and numerous stakeholders from the provider and patient community to unpackage diagnostic radiopharmaceuticals.

Reps. Peters and Rush closed their letter by urging CMS to change this policy in light of the adverse impact on beneficiary access and care. This comes on the eve of the introduction of the Facilitating Innovative Nuclear Diagnostics Act of 2021, a bill aimed at solving this very problem if CMS again declines to do so.

For more information on the Facilitating Innovative Nuclear Diagnostics (FIND) Act of 2021, please click here or contact