June 16, 2026: MEDICARE PART B CONTRACTORS PROPOSE LOCAL COVERAGE DETERMINATIONS THAT WILL LIKELY LIMIT PATIENT ACCESS TO DRUG-ELUTING SYSTEMS

MEDICARE PART B CONTRACTORS PROPOSE  LOCAL COVERAGE DETERMINATIONS THAT WILL LIKELY LIMIT PATIENT ACCESS TO DRUG-ELUTING SYSTEMS

Medicare contractors have issued a proposed LCD which embodies the potential to significantly limit ophthalmologists’ ability to implant anterior segment intraocular nonbiodegradable drug-eluting systems like iDOSE.  There are a number of problems associated with this proposal that the ophthalmology community is addressing in extensive communications with the contractors and CMS.

The LCD provides:

A single Food and Drug Administration (FDA) approved anterior segment intraocular nonbiodegradable drug-eluting system is considered reasonable and necessary for the management of OHT or POAG, per eye, when ALL of the following criteria have been met:

1. History of failed medical management, defined as:
   1. Tried at least 2 ophthalmic topical drops (given as sequential monotherapies or together simultaneously) for the treatment of OAG or OHT AND
   2. The ophthalmic drops did not achieve the initial treatment goal of a reduction of 20% to 30% from the patient’s baseline IOP measurement OR
   3. Adverse side effects from different ophthalmic drops severe enough to warrant discontinuation OR
   4. The patient is unable to physically place eye drops due to disability such as severe tremors or loss of use of dominant hand, and there is no caretaker who is able to perform the administration of the drops, AND
2. History of failed SLT, defined as the procedure did not result in clinically significant reduction of IOP

Limitations:

1. Device implantation cannot be performed concomitantly with other eye surgeries or procedures except phacoemulsification cataract surgery. If performed with cataract surgery, all criteria above must be met, and no other eye surgery can be performed at the same time.
2. Device implantation is not permitted when contraindications (as stated in the FDA label) are present.
3. Device cannot be re-administered within 2 years of insertion.
4. Preimplantation, the patient’s Central Corneal Endothelial Cell Density must be at or above the FDA label-recommended Minimum Central Corneal Endothelial Cell Density.

Medicare contractors are holding several hearings this month to hear from interested parties, including ophthalmology organizations.  At these meetings, AAO, ASCRS, AGS, and OOSS are addressing a number of concerns all of which encompass our view that the provisions may exceed the current evidence base, may limit medically necessary clinician flexibility, and impose a risk of unintended patient access barriers. 

Our organizations will also be submitting formal comments to the contractors; the comment period closes on July 4.

One can review the proposed LDC at: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=40358&ver=4. 

Should you have any questions, please contact OOSS Washington Counsel, Michael Romansky, at mromansky@OOSS.org