US · guidance
CMS Pub. 100-04, ch. 4, § 40.5
Transitional Pass-Throughs for Designated Drugs or Biologicals
Certain current designated drugs and biologicals are assigned to special APCs. I/OCE
identifies these and assigns the appropriate APC. Fiscal Intermediary Shared System
(FISS) establishes payment at the average sales price (ASP) drug fee amount minus the
portion of the otherwise applicable APC payment amount. I/OCE and FISS will
determine the proper payment amount for these APCs as well as the coinsurance and any
applicable deductible. All related payment calculations will be returned by the I/OCE
and FISS, identified as a designated drug and biological with status indicator (SI)
“K”. Certain new designated drugs and biologicals may be approved for payment, and
their payment will be calculated in the same manner as listed above for current
designated drugs and biologicals. IOCE identifies these new designated drugs and
biologicals (SI “G”) separately from the current designated drugs and biologicals (SI
“K”).
Note: See section 40.1 for the I/OCE instructions and specifications
History
(Rev. 3941; Issued: 12-22-17; Effective: 01- 01-18; Implementation: 01-02-18)
Provenance
- Source
- cms.gov
- Retrieved
- 2026-08-25
- Edition
- iom-2026-08-25
- Content hash
f562ff80bd5de1e5b1f4eaae2dcc30a6b2215e51690401c690bfaa301af5f470
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