News
Fraud, Waste & Abuse
Compliance
Claims, Pricers & Codes
- COVID-19 Vaccine Pricing for 2025–2026 Season
- Ambulatory Surgical Center: Medicare Approved New High-Cost Gene Therapy Drug
- Medicare Part B Drug Pricing Files & Revisions: October Update
- Medicare Physician Fee Schedule Database: October Update
- Clinical Laboratory Fee Schedule: Revised Third Quarter File
MLN Matters® Articles
News
Clinical Laboratory Fee Schedule: Submit Comments & Reconsideration Requests by October 9
Get the latest payment information on the Clinical Laboratory Fee Schedule (CLFS), and find out how to comment or request a reconsideration by October 9:
- CY 2026 preliminary payment determinations (ZIP): Submit comments to CLFS_Annual_Public_Meeting@cms.hhs.gov
- Final Medicare Administrative Contractor 2025 gapfill recommendations for CY 2026 (ZIP):
- Submit payment reconsideration requests to CLFS_Inquiries@cms.hhs.gov
- Once CMS posts the final, complete CY 2026 CLFS fee schedule, the gapfilled payment amount is final
Visit the CLFS Annual Public Meetings webpage for more information on the annual rate setting processes.
Fraud, Waste & Abuse
CMS IDea Challenge: Submit Interest Form by September 26
CMS will host 2 in-person events to combat fraud involving health plan identifiers (IDs) and enhance their security. These collaborative events will bring together experts from diverse backgrounds to develop innovative ways to protect patient information.
Attendees will spend a full day working in small teams developing ideas to improve member ID security. At the end of the day, each group will pitch their solutions to CMS and vote on a winning concept.
CMS is seeking participants who can offer varied perspectives to better protect patient information. No advance preparation is required, and you don’t need technical skills to participate.
Event Dates:
- November 5, 2025, 9 am – 5 pm PT, San Francisco, California
- November 13, 2025, 9 am – 5 pm ET, New York, New York
More Information:
- Submit an interest form by September 26, 2025, to participate
- Visit CMS IDea Challenge: Strategies for Securing Member IDs
Compliance
Orthopedic Footwear: Prevent Claim Denials
In 2023, the improper payment rate for orthopedic footwear was 100%, with a projected improper payment amount of $4.3 million (see 2023 Medicare Fee-for-Service Supplemental Improper Payment Data (PDF)). Learn how to bill correctly for these services. Review the Orthopedic Footwear provider compliance tip for more information, including:
- Billing codes
- Denial reasons and how to prevent them
- Documentation requirements
Claims, Pricers & Codes
COVID-19 Vaccine Pricing for 2025–2026 Season
CMS updated COVID-19 payment allowances for the 2025–2026 season. Visit the Vaccine Pricing webpage for the most current list of billing codes, including short descriptors and effective dates.
There’s 1 new code for this season. CPT code 91323 is effective August 27, 2025:
- Long descriptor: MNEXSPIKE COVID-19 mRNA (2025-2026) 10 mcg/0.2 mL, single dose High Risk 12-64Y/Over 65Y
- Short descriptor: SARSCOV2 VAC 10 MCG/0.2ML IM
Ambulatory Surgical Center: Medicare Approved New High-Cost Gene Therapy Drug
We updated this message on October 30, 2025
Medicare approved the groundbreaking new cell gene therapy drug, Encelto™ for use in the ambulatory surgical center setting. It’s effective for claims with dates of service on or after October 1, 2025.
Claims should be submitted the same way as chimeric antigen receptor T-cell therapy. See the Medicare Claims Processing Manual, Chapter 32 (PDF), section 400.2.5.
When you bill for Encelto:
- Submit multiple claims and append the LU modifier (fractionated billing) and the 76 modifier (repeat service or payment by the same physician or other qualified health care professional)
- Use code J3403 (revakinagene tarorectcel-lwey, per implant) and payment indicator K2
Billing claims example — Each unit with dose with a payment amount of $257,500:
- 0.2 units = $ 51,500.
- Note: Medicare Administrative Contractors can only pay up to one unit. Anything exceeding 1 unit will be denied.
Medicare Part B Drug Pricing Files & Revisions: October Update
Learn about quarterly updates to the following average sales price and not otherwise classified pricing files:
- October 2025
- July 2025
- April 2025
- January 2025
- October 2024
See the instruction to your Medicare Administrative Contractor (PDF).
Medicare Physician Fee Schedule Database: October Update
See the instructions to your Medicare Administrative Contractor (MAC) (PDF) to learn about the October quarterly updates to the Medicare Physician Fee Schedule Database, including:
- New codes
- Procedure status changes
- Short descriptor code revisions
- Payment policy indicator changes
Your MAC will give you 30-days notice before they implement these changes. After that, they’ll adjust claims that you bring to their attention.
For more information, see the Medicare Claims Processing Manual, Chapter 23 (PDF), section 30.1.
Clinical Laboratory Fee Schedule: Revised Third Quarter File
CMS revised the third quarter Clinical Lab Fee Schedule file. We added the following Clinical Laboratory Improvement Amendments waived test codes with the QW modifier:
- G0567QW
- 87563QW
- 87491QW
- 87591QW
- 0563UQW
- 0564UQW
Your Medicare Administrative Contractor will reprocess affected claims. You don’t need to take any action.
MLN Matters® Articles
National Fee Schedule for Vaccine Administration: October 2025 Update
Learn about coding updates (PDF) for:
- AVTOZMA® for post-exposure prophylaxis or COVID-19 treatment
- Newly FDA-approved products not yet assigned to a unique HCPCS Level II code
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