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Series: Review of Medicare Part B Claims for Intravitreal Injections of Eylea and Lucentis

Announced on  | Last Modified on  | Series Number: W-00-24-30100
Status
Completed
Agency
Centers for Medicare and Medicaid Services

OBJECTIVE

Medicare Part B covers ophthalmology services that are reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member. Ophthalmology services include intravitreal injections of Eylea and Lucentis to treat eye diseases such as wet age-related macular degeneration. Medicare pays for an intravitreal injection (which is considered a minor surgery) as part of a global surgical package that includes the preoperative, intraoperative, and postoperative services routinely performed by the physician. Medicare pays for Eylea and Lucentis separately from the intravitreal injection. Chapter 12, section 40.1 of the Centers for Medicare & Medicaid Services' Medicare Claims Processing Manual states that separate payment can be made for other services provided by the same physician on the same day as the global surgery if the services are significant and separately identifiable or unrelated to the surgery. We will review claims for intravitreal injections of Eylea and/or Lucentis and the other services billed on the same day as the injection, including evaluation and management services, to determine whether the services were reasonable and necessary and met Medicare requirements.

There are 2 projects in this series.

COMPLETED PROJECTS IN THIS SERIES (2)

Florida Retina Institute

Project A-04-22-04086 • Completed on December 2, 2025

Medicare Program Oversight

Project A-09-23-03014 • Completed on May 27, 2025

TIMELINE

  • October 12, 2021
    Series Number W-00-24-30100 Assigned
  • October 12, 2021
    Project Announced

    Florida Retina Institute - A-04-22-04086

  • September 13, 2023
    Project Announced

    Medicare Program Oversight - A-09-23-03014

  • May 27, 2025
    Project Complete - A-09-23-03014

    Medicare Program Oversight has been marked as complete. This audit resulted in 3 recommendations.

  • December 2, 2025
    Project Complete - A-04-22-04086

    Florida Retina Institute has been marked as complete. Report Published

  • December 2, 2025
    Series Complete

    Review of Medicare Part B Claims for Intravitreal Injections of Eylea and Lucentis has been marked as complete.

2 REPORT PUBLISHED

Florida Retina Institute Generally Met Medicare Requirements for Ophthalmology Services Provided on the Same Day as Eye Injections (A-04-22-04086)
  • FRI generally complied with Medicare requirements when billing for ophthalmology services provided on the same day as intravitreal injections. For 92 of the 100 sampled patient days, FRI complied with Medicare requirements for all services billed; for 8 sampled patient days it did not. Specifically, FRI incorrectly billed Medicare for services that were not medically necessary and not separately identifiable from the intravitreal injection.
  • We estimated that Medicare made overpayments totaling at least $42,295 to FRI for ophthalmology services that did not comply with Medicare requirements.
  • The overpayments in our sample occurred because FRI did not fully implement its policy of monitoring its claims process to promptly identify deficiencies that would affect the accuracy of its claims.
No recommendations were issued as a part of this report.

Medicare Payments for Evaluation and Management Services Provided on the Same Day as Eye Injections Were at Risk for Noncompliance With Medicare Requirements (A-09-23-03014)

25-A-09-066.01 to CMS - Open Unimplemented
Update expected on 11/26/2025
We recommend that the Centers for Medicare & Medicaid Services update Medicare requirements for billing E&M services provided on the same day as intravitreal injections to help providers understand the appropriate use of modifier 25 (e.g., clarify the definition of a "significant and separately identifiable" E&M service and identify the circumstances that allow for an E&M service to be billed on the same date of service as an intravitreal injection).

25-A-09-066.02 to CMS - Open Unimplemented
Update expected on 03/17/2026
We recommend that the Centers for Medicare & Medicaid Services conduct medical reviews of E&M services that were provided on the same day as intravitreal injections to determine whether these payments were improper and, consistent with relevant laws and the agency's policies and procedures, recover payments of up to $123,955,176 for E&M services that CMS determines should not have been billed with modifier 25 during our audit period, and instruct those providers to refund to enrollees any coinsurance amounts that may have been incorrectly collected from them or from someone on their behalf.

25-A-09-066.03 to CMS - Open Unimplemented
Update expected on 03/18/2026
We recommend that the Centers for Medicare & Medicaid Services provide more education to providers on billing E&M services provided on the same day as intravitreal injections and the appropriate use of modifier 25 to help prevent improper payments for those services. For example, CMS could: (1) emphasize that the decision to perform an intravitreal injection is part of the minor surgical procedure and a separate E&M service should not be billed for that work; (2) provide a clear definition of a "significant and separately identifiable" E&M service that is "above and beyond" the usual care associated with an intravitreal injection; and (3) provide examples of E&M services that would be considered significant and separately identifiable and above and beyond the usual care associated with an intravitreal injection.

View in Recommendation Tracker
Work Plan Type
Office of Audit Services
HHS Agencies
Centers for Medicare and Medicaid Services
Issue Areas
Physician and Healthcare Practitioners
Target Groups
Elderly
Financial Groups
Medicare B