CMS Pub. 100-02, ch. 11, § 50.1

As discussed in 20.3.D of this chapter, CMS finalized a policy in the CY 2011 ESRD PPS final rule (75 FR

49044) to delay payment for oral-only renal dialysis drugs and biological products under the PPS until

January 1, 2014. This was further delayed until CY 2025 as a result of legislation. Calcimimetics are a

renal dialysis drug that falls within the bone and mineral metabolism functional category. Prior to CY

2018, calcimimetics were considered oral-only and were excluded from the ESRD PPS; however, an

injectable calcimimetic was approved by the FDA in 2017. Beginning January 1, 2018, injectable and oral

calcimimetics were incorporated into the ESRD PPS and paid under the TDAPA for an initial TDAPA

period of 2 years, which was extended in the CY 2020 ESRD PPS final rule to include a third year.

Effective January 1, 2021, the ESRD PPS base rate increased by $9.93 to account for oral and injectable

calcimimetics. Using the total units of oral and injectable calcimimetics and the total number of paid

hemodialysis-equivalent dialysis treatments furnished, as derived from Medicare ESRD facility claims (that

is, the 837-institutional form with bill type 072X) for the third and fourth quarters of calendar year 2018

and for the full calendar year 2019 and the weighted average ASP based on the most recent determinations

by CMS, CMS used the following methodology to calculate the average per treatment payment amount for

calcimimetics that is added to the ESRD PPS base rate (see 42 CFR § 413.234(f)).