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2026-08-20 - DMEPOS Competitive Bidding Program: Get Ready for Round 2028
Effective date
Oct 1, 2025
Identified
Aug 20, 2026
Summary
This MLN Connects Newsletter (August 20, 2026) contains multiple policy updates including: (1) new DMEPOS Competitive Bidding Program Round 2028 fact sheets and updated bid surety bond amounts for remote item delivery areas; (2) billing guidance for Encelto™ cell gene therapy (HCPCS J3403) requiring fractionated unit billing with LU and 76 modifiers; (3) updated 2026 HCPCS application summaries; and (4) ICD-10 coding revisions effective January 1, 2027. The most immediately actionable item is the Encelto billing guidance for claims with dates of service on or after October 1, 2025.
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What to do
Action · 11 steps
01REQUIREMENTS:
1. IMMEDIATE (Before processing Encelto claims):
- Billing team: Update billing software to recognize HCPCS code J3403 (revakinagene taroretcel-lwey, per implant) for ASC and hospital outpatient claims.
02- Billing team: Implement fractionated unit billing logic in claims system for J3403.
03When splitting payment amounts, ensure claims are submitted with LU modifier (fractionated billing) and 76 modifier (repeat service) appended.
04- Billing team: Configure system to enforce the following rules for J3403:
* Maximum 1 total unit per date of service per eye treatment
* Support decimal unit increments (0.1 or 0.2 preferred)
* Calculate fractionated charges correctly (e.g., for $261,579.65 payment: 9 claims at 0.1 unit/$26,157.96 + 1 claim at 0.1 unit/$26,158.01 if using 0.1 increments)
- Providers: Review Medicare Claims Processing Manual Chapter 32, section 400.2.5 for CAR-T therapy billing parallels.
05- Consequence: Claims for Encelto submitted without proper fractionated billing and modifiers will be denied or processed incorrectly.
062. By January 1, 2027:
- Billing/Coding team: Review and implement ICD-10 and other coding revisions to National Coverage Determinations (January 2027 Update) in billing system and encoder software.
07- Update encounter forms and templates to reflect new coding requirements.
08- Consequence: Claims submitted with outdated codes may be denied or incorrectly processed.
093. Before Bidding Period Opens (DMEPOS Round 2028):
- DMEPOS bidders: Review all four new fact sheets on the CBIC website (Antitrust Guidance, Common Ownership & Common Control, Determining Number of Contract Awards & Single Payment Amount, Round 2028 Terms & Definitions).
10- Update bid preparation materials and bid surety bond amounts based on FY 2027 Inpatient Rehabilitation Facility Prospective Payment System final rule for remote item delivery competitive bidding areas.
11- Consequence: Non-competitive or non-compliant bids may be rejected.
Codes mentioned
J3403LU76
Original notice
2026-08-20 - DMEPOS Competitive Bidding Program: Get Ready for Round 2028
cms.gov · Always check the source before changing claims.