§419.64. Transitional pass-through payments: Drugs and biologicals. — Inbound Citations

(2) The drug or biological does not have transitional pass-through payment status under § 419.64 of this subchapter. In the case where a drug or biological otherwise meets the requirements under this section and has transitional pass-through payment status that expires during the calendar year, the drug or biological will qualify for separate payment as specified in this paragraph (a) during such calendar year on the first day of the next quarter following the expiration of its pass-through status.

(h) For a therapeutic radiopharmaceutical for which payment is not packaged into a payment for a covered outpatient department (OPD) service (or group of services) and that does have on transitional pass-through payment status as described in § 419.64, to calculate the program payment and copayment amounts CMS does the following:

(1) Determines the average sales price (ASP) for the therapeutic radiopharmaceutical for the quarter established under the methodology described by section 1847A of the Act. If that amount is not available, then CMS calculates the mean unit cost (MUC) using the most recently available claims data for that therapeutic radiopharmaceutical.

(2) Subtracts from the amount determined under paragraph (h)(1) of this section the amount of the applicable Part B deductible provided under § 410.160 of this chapter.

(3) Multiplies the amount determined under paragraph (h)(1) of this section (less any applicable deductible under paragraph (h)(2) of this section) by 20 percent. This is the beneficiary's copayment amount for the drug or biological.

(4) Subtracts the amount determined under paragraph (h)(3) of this section from the amount determined under paragraph (h)(1) of this section (less any applicable deductible determined under paragraph (h)(2) of this section). This amount is the preliminary program amount.

(5) Adds to the preliminary program amount determined under paragraph (h)(4) of this section the amount by which the copayment amount would have exceeded the inpatient hospital deductible for that year. This amount is the final Medicare program payment amount.

(ii) The drug or biological does not have transitional pass-through payment status under § 419.64. In the case where a drug or biological otherwise meets the requirements under this section and has transitional pass-through payment status that expires during the calendar year, the drug or biological will qualify for separate payment as specified in this paragraph (k) during such calendar year on the first day of the next calendar year quarter following the expiration of its pass-through status.

(a) CMS provides for additional payments under §§ 419.64 and 419.66 for certain innovative medical devices, drugs, and biologicals.