US MACs Retire Coverage Policies That Would Have Limited Some MIGS Procedures

Five Medicare administrative contractors (MACs) have withdrawn and retired final policies that would have stopped Medicare coverage of common minimally invasive glaucoma surgeries in their US jurisdictions.

The MACs in 2023 proposed no longer covering or severely limiting coverage of ab interno canaloplasty, viscocanaloplasty, goniotomy, cyclophotocoagulation, and other procedures.

Two factors that led to the proposal were the MACs’ perception that the procedures lacked clinical data showing medical necessity and a marked increase in those procedures in recent years.

MACs are private health care insurers that have been awarded a geographic jurisdiction by the Centers for Medicare and Medicaid Services to process medical claims. They have authority to determine whether an item or service is reasonable and necessary and covered.

The five MACs involved were WPS Government Health Administrators, Palmetto GBA, Celerian Group Company, National Government Services, and Noridian Healthcare Solutions.

They retired their policies on Dec. 28, a month before the changes were set to take effect on Jan. 29, 2024, a date delayed from Dec. 24, 2023.

Ophthalmic companies that market devices that would have been affected include Sight Sciences (Omni and Sion); Glaukos (iPrime and iAccess); New World Medical (Streamline, Kahook Dual Blade, KDB Glide); Nova Eye (iTrack); and Iridex (MicroPulse laser technology).

The MACs published their final policies in November, but ophthalmic companies continued to lobby the MACs to reconsider and published additional efficacy and safety data, which the companies had not been required to show to gain 510(k) approval for the devices.

Some companies canceled year-end revenue guidance, while one halted trading of its stock twice, as they faced an existential threat.

As news of the retired policies spread on Dec. 28, Sight Sciences published a press release thanking passionate glaucoma surgeons and eye care societies—including the American Academy of Ophthalmology, American Glaucoma Society, American Society of Cataract and Refractive Surgery, and Outpatient Ophthalmic Surgery Society—in addition to state societies that “all worked collaboratively and tirelessly to provide valuable and critical feedback to the MACs, CMS, and Congressional offices during this rigorous review process.”

Market Scope will discuss in the January 2024 edition of Ophthalmic Market Perspectives what this means for MIGS device makers going forward.