Payment for non-opioid pain management drugs and biologicals that function as supplies in surgical procedures.

  1. Law
  2. CFR 42
  3. Public Health
  4. Centers for Medicare & Medicaid Services, Department of Health and Human Services
  5. Medicare Program
  6. Ambulatory Surgical Services
  7. Coverage, Scope of ASC Services, and Prospective Payment System for ASC Services Furnished on or After January 1, 2008
  8. Payment for non-opioid pain management drugs and biologicals that function as supplies in surgical procedures.

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§ 416.174 Payment for non-opioid pain management drugs and biologicals that function as supplies in surgical procedures.

(a) Eligibility for separate payment for non-opioid pain management drugs and biologicals. Beginning on or after January 1, 2022, a non-opioid pain management drug or biological that functions as a surgical supply is eligible for separate payment if CMS determines it meets the following requirements:

(1) The drug is approved under a new drug application under section 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA), under an abbreviated new drug application under section 505(j), or, in the case of a biological product, is licensed under section 351 of the Public Health Service Act. The product has an FDA approved indication for pain management or analgesia.

(2) The per-day cost of the drug or biological must exceed the OPPS drug packaging threshold set annually through notice and comment rulemaking.

(b) [Reserved]

[86 FR 63993, Nov. 16, 2021]


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