Federal Legislative Efforts

Since 2008, Medicare has “packaged” payment for diagnostic radiopharmaceuticals into payment for the molecular imaging tests conducted by nuclear medicine providers in hospital outpatient facilities. Physicians use these tests to diagnose cancer and cardiac conditions, as well as degenerative neurological diseases such as Parkinson’s and Alzheimer’s diseases, and determine the appropriate course of treatment for their patients.

Medicare’s packaged rates for such studies are the same regardless of whether they involve a high-volume, lower-cost diagnostic radiopharmaceutical or a low-volume, higher-value precision diagnostic tool that can facilitate more targeted treatment --  even when the cost of the precision medicine drug can substantially exceed the entire packaged reimbursement.

Unfortunately, Congress did not pass the Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2019 (H.R. 3772). However, now that we are in a new legislative session, SNMMI and its coalition partners are working to introduce a new bill for 2021.  This bill would ensure that Medicare patients have access to precision diagnostic imaging studies prescribed by their physicians when clinically appropriate, and that hospitals are appropriately reimbursed for the cost of such tests.

We are seeking providers and patient advocates! To participate in virtual or in-person Congressional fly-ins and/or briefings, please contact hpra@snmmi.org. 

Historical Documentation on HR. 3772

Events and activities related to H.R. 3772 may be found on our Government Relations News page. 

• Click here to view a list of our co-sponsors and legislative history.
• The full text of the bill may be found here.
• A list of supporting organizations and fact sheet may be found here. 
• The video recording of our patient advocacy webinar and slide deck are available here.

Section by Section Analysis of the Legislation

Section 1. Short Title. Bill title.

Section 2(a). Separate Payment for Certain Diagnostic Radiopharmaceuticals.

Section 2(a) would add a provision to Medicare’s Hospital Outpatient Prospective Payment System (OPPS system) to:

• Direct the Secretary of Health and Human Services to pay separately under the OPPS system for diagnostic radiopharmaceuticals (Dx RPs) with an estimated mean per day product cost exceeding $500. The provision would take effect on or after January 1, 2020. In subsequent years, the threshold would increase by the inflation update CMS applies to outpatient department payments.

• Establish reimbursement for eligible Dx RPs at the average sales price (ASP) for the drug, to the extent When ASP is not available, the Dx RP would be paid the wholesale acquisition cost (WAC) or, if WAC is not available, the mean unit cost data derived from hospital claims data.

• Preserve transitional pass–through payment for additional costs of innovative Dx RPs under Section 1833(t)(6) of the Social Security Act.

• Ensure that the Secretary implements separate payment in a budget neutral manner by harmonizing the cost of separate payment across the OPPS system.
• Limit eligible Dx RPs to drugs approved by the Food and Drug Administration on or after January 1, 2008, the date that the Medicare program began bundling reimbursement for hospital outpatient procedures involving Dx RPs.

Section 2(b). No Impact on Copayment.

This section would ensure that Medicare beneficiaries will not incur an additional copayment obligation for separately paid Dx RPs.