March 23, 2018
Section 1301 of the 2018 Budget Bill will reverse the decision of the Centers for Medicare and Medicaid Services (CMS) to take some drugs off of pass-through status effective January 1, 2018. They will return to pass-through status on October 1, 2018, through December 31, 2019. The payment rate for the ambulatory payment groups will be adjusted (downward) to make this a revenue neutral change. This does not affect radiopharmaceuticals that went off pass-through status earlier or those scheduled to go off pass-through status in the future. There is, however, hope that this action will encourage CMS to treat high-value radiopharmaceuticals better in the future. Our initial assessment is that Lilly's Amyvid is the biggest beneficiary of this change.
The law also mandates that the Government Accountability Office (GAO) study CMS's "policy for packaging high-cost drugs and biologicals after their pass-through status...has expired ..." The study will analyze the impact of CMS's policy on the utilization of these drugs, the availability of treatment options, the resulting impacts on health outcomes and the impact on price competition and cost-sharing. The report is due to Congress no later than March 1, 2021, and should include whatever legislative and regulatory changes the GAO deems appropriate.
Dr. Munir Ghesani, Chair of SNMMI's Committee on Government Relations notes that "while it is good to see Congress taking some action on this problem, much more needs to be done. CMS should stop taking radiopharmaceuticals off of pass-through status and should return to pass-through status many that were taken off earlier. The GAO study is welcome, but we hope it can be completed before 2021 as more action is needed before then."