Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System (CMS-10008)

Section 1833(t)(6) of the Act provides for temporary additional payments or “transitional pass-through payments” for certain drugs and biological agents. As originally enacted by the Balanced Budget Refinement Act (BBRA), this provision required the Secretary to make additional payments to hospitals for current orphan drugs, as designated under section 526 of the Federal Food, Drug, and Cosmetic Act (Pub. L. 107-186); current drugs and biological agents and brachytherapy used for the treatment of cancer; and current radiopharmaceutical drugs and biological products. For those drugs and biological agents referred to as “current,” the transitional pass-through payment began on the first date the hospital OPPS was implemented (before enactment of Benefits Improvement and Protections Act (BIPA) (Pub. L. 106-554), on December 21, 2000). Transitional pass-through payments are also required for certain “new” drugs, devices and biological agents that were not being paid for as a hospital outpatient department (OPD) service as of December 31, 1996, and whose cost is “not insignificant” in relation to the outpatient perspective payment system (OPPS) payment for the procedures or services associated with the new drug, device, or biological. Under the statute, transitional pass- through payments can be made for at least 2 years but not more than 3 years.

The latest form for Transitional Pass through payments related to Drugs, Biologicals, and Radiopharmaceuticals to determine eligibility under the Outpatient Prospective Payment System (CMS-10008) expires 2021-12-31 and can be found here.