Pass-through and packaging for CY 2027: 9 device pass-through approvals, 49 drugs' pass-through ending, sheet-form skin substitutes held at $127.14 per cm2
Published November 8, 2026 · Coverage November 1–7, 2026, Pacific · Lower priority
CMS approved device pass-through status for nine applications and denied four for CY 2027. Pass-through status for 49 drugs and biologicals expires by December 31, 2026. The CY 2027 drug packaging threshold is $135 per day and the diagnostic radiopharmaceutical threshold is $635 per day in the rule's final computation (one paragraph of the rule calls $665 final; confirm against the addenda). CMS kept the single $127.14 per cm2 rate for sheet-form skin substitutes and moved application codes G0681 and G0683 for non-sheet products to separately paid status indicator T (Ambulatory Payment Classifications (APCs) 5053 and 5054); non-sheet products themselves stay assigned to status indicator N.
Background
Under the Hospital Outpatient Prospective Payment System (OPPS), transitional pass-through payments are temporary additional payments, for at least 2 but not more than 3 years, for certain drugs, biological agents, brachytherapy devices used for the treatment of cancer, and categories of other medical devices; the 49 drugs and biologicals whose status now expires will have received pass-through payment for 3 years during the period of April 1, 2023 through December 31, 2026. For CY 2026, CMS began paying separately for skin substitute products as incident-to supplies in the physician office, hospital outpatient and ambulatory surgical center settings, effective January 1, 2026, excluding skin substitutes approved as biological products under section 351 of the Public Health Service Act, which continue to be paid consistent with section 1847A of the Social Security Act, and set an initial payment rate of $127.14 per cm2 for sheet-form skin substitute products.
Who this affects
Hospital pharmacy, supply chain and chargemaster functions.
Why it matters
Chargemaster and pharmacy billing need updates for the 49 drugs and biologicals whose pass-through status expires and for the nine newly approved device pass-through categories. Inference: wound care departments using non-sheet products can bill application codes G0681 and G0683 separately from January 1, 2027 (the change covers those two codes).
Recommended action
- Reconcile the expiring pass-through list (Table 57) and new device categories to the chargemaster before January 1, 2027
Scope and timing
- Authority status
- Final
- Responsible owner
- Pharmacy / Chargemaster / Supply Chain
- Publication date
- 2026-11-06
- Effective date
- 2027-01-01
- Other dates
- 49 drugs' pass-through status expires by 2026-12-31
Not established
Device names and drug lists (Tables 50, 57-59) not worked up.
Sources
Complete edition and supplemental material
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