CMS Releases Its List of 43 Part B Rebatable Drugs for Q3: Inflation Reduction Act Updates

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Epstein Becker & Green

On June 9, 2023, the Centers for Medicare & Medicaid Services (CMS) issued its next list of Part B drugs subject to the Medicare Prescription Drug Inflation Rebate Program’s adjusted coinsurance rates (“Rebatable Drugs”) from July 1 through September 30 (“Q3 Rebatable Drug List”).

CMS intends to invoice manufacturers for the rebate penalty amounts imposed for increasing the prices of the Rebatable Drugs faster than the rate of inflation. CMS published the list of Part B Rebatable Drugs for the upcoming quarter as part of the Medicare Part B Drug and Biological Average Sales Price (ASP) Quarterly Payment file.

Inflation-Adjusted Coinsurance Percentages for Q3 Rebatable Drugs

NEWLY ADDED REBATABLE DRUGS FOR Q3

ADCETRIS 19.494% LUPRON DEPOT-PED 19.376%
AGGRASTAT 19.483% MONONINE 19.929%
BLINCYTO 19.331% NPLATE 19.718%
CRYSVITA 19.812% ONCASPAR 19.129%
CUVITRU 19.970% PANHEMATIN 19.461%
ENJAYMO 19.825% PROLIA 19.829%
FOLOTYN* 19.902% SYNRIBO 18.895%
GAMMAGARD S/D 19.380% TEZSPIRE 19.899%
GAMMAPLEX 19.155% TROGARZO 19.820%
IMLYGIC 19.570% VABOMERE 19.828%
INFUGEM 19.397% VARIZIG 19.560%
KYPROLIS 19.685% VECTIBIX 19.646%
    VIVITROL 19.948%
  • Mircera and Sylvant—listed as Rebatable Drugs in Q2—were removed from the Q3 Rebatable Drug List.
  • *Folotyn was included in the initial Rebatable Drug list for Q2 but removed from the final list.

DRUGS THAT CONTINUE TO BE REBATABLE DRUGS FROM Q2 TO Q3

DRUG NAME Q2 2023 
FINAL LIST (3/29)
Q3 2023
INITIAL (6/9)
CHANGE FROM
Q2 TO Q3
ABELCET 19.29% 19.368% 0.08%
AKYNZEO 16.31% 15.691% -0.62%
ATGAM 17.93% 18.075% 0.14%
AVEED 19.35% 18.825% -0.53%
BICILLIN C-R 19.03% 17.573% -1.46%
BICILLIN L-A 18.62% 17.233% -1.39%
CARNITOR 14.00% 13.558% -0.44%
CYTOGAM 19.09% 19.173% 0.08%
FLEBOGAMMA DIF 17.76% 14.150% -3.61%
FRAGMIN 14.08% 11.892% -2.19%
HUMIRA 19.64% 19.720% 0.08%
LEUKINE 19.76% 19.422% -0.34%
MINOCIN 19.40% 19.079% -0.32%
NIPENT 17.37% 18.882% 1.51%
PADCEV 19.59% 19.658% 0.07%
RYBREVANT 19.86% 19.990% 0.13%
SIGNIFOR LAR 18.51% 19.049% 0.53%
XIAFLEX 19.07% 19.101% 0.03%

Key Considerations

  • CMS states that “[f]rom time to time, ASP public files need to be corrected or updated … based on feedback received after the files are published. If CMS receives feedback that necessitates updates to this list of drugs with adjusted coinsurance amounts, CMS will update the list,” which could occur “either before the start of the quarter or after in the event updated data becomes available.”
  • Notably, CMS issued its first list of Part B Rebatable Drugs for Q2 on March 15, 2023, then later that month, CMS updated the Q2 Rebatable Drug list to remove seven drugs.

Next Steps for Stakeholders

  • Manufacturers should evaluate whether to submit feedback to CMS about their Rebatable Drugs.

Related Documents

Date of Issuance: June 9, 2023 

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