Medical Administrative Contractors withdraw final LCDs on MIGS

(Image Credit: AdobeStock/kamiphotos)

The new year starts off with a decision announced by 5 Medicare Administrative Contractors (MACs) to withdraw their final local coverage determinations (LCDs) for micro-invasive glaucoma surgery (MIGS).

Those LCDs were set to take effect on January 29, 2024.

According to a Sight Sciences news release,¹ the MACs, including WPS Government Health Administrators, Celerian Group Company, Palmetto GBA, National Government Services, and Noridian Healthcare Solutions, had published LCDs on MIGS, which identified certain procedures as investigational for glaucoma management in patients over the age of 18, including canaloplasty in combination with trabeculotomy ab interno, which is a procedural description associated with the company’s OMNI Surgical System.

All five MACs have now issued statements that the final LCDs will not go into effect on January 29, 2024. As a result, there will be no change in January 2024 to the current Medicare coverage for MIGS procedures performed with the OMNI Surgical System.¹

Paul Badawi, co-founder, and CEO of Sight Sciences, said in the news release the company appreciates that the MACs and the Centers for Medicare & Medicaid Services (CMS) considered all stakeholder concerns with the LCDs and the serious potential risks to patient health and access to effective glaucoma care.

“We look forward to continued engagement with the MACs and CMS to ensure glaucoma patients and their physicians maintain appropriate and fair access to medically reasonable and necessary MIGS procedures and technology,” Badawi said in the news release. “We would like to thank the many passionate glaucoma surgeons around the country and the national and state eye care societies including notably the American Academy of Ophthalmology, the American Glaucoma Society, the American Society of Cataract and Refractive Surgery, and the Outpatient Ophthalmic Surgery Society, who all worked collaboratively and tirelessly to provide valuable and critical feedback to the MACs, CMS, and Congressional offices during this rigorous review process. Additionally, we appreciate the support from the Medical Device Manufacturers Association (MDMA) and numerous patient advocacy groups.”

The movement to cut reimbursements and coverage for MIGs procedures began quietly in spring 2023, so quietly that most subspecialists remained relatively unaware of the movement afoot. The basic premise was that significant limitations were to be placed on goniotomy and cyclophotocoagulation procedures; and canaloplasty, a relied-upon tool for glaucoma surgeons treating adults for many years, was now considered investigational.

Industry input

Iridex and Sight Sciences both filed 8Ks with the Securities and Exchange Commission to inform their investors of the LCD. Iridex manufactures the Cyclo G6 Laser System and Probe Delivery Devices for use in otolaryngology and ophthalmology and Sight Sciences the OMNI Surgical System for use during trabeculotomy ab interno.²

Iridex pointed out in a news release last fall that, “Although the LCD does not deny coverage, it imposes additional requirements for reimbursement. Among the issues examined are (i) the intent of the LCD; (ii) the use and application of definitions within the LCD (e.g., how a determination expressly defined as relating to incisional surgical techniques pulled within its scope non-incisional transscleral cyclophotocoagulation); and (iii) the LCD’s failure to recognize any distinctions among (a) endo cyclophotocoagulation and (b) transscleral cyclophotocoagulation, or (x) continuous wave cyclophotocoagulation and (y) micropulse cyclophotocoagulation.

Sight Science, in an October press release, stated, “[The] Company strongly disagrees with the LCD’s characterization of the FDA-cleared, intraocular pressure-lowering procedure involving the OMNI technology as investigational, and will pursue all remediation possibilities to maintain or reinstate coverage.”

In addition to all other peer-reviewed, published clinical evidence already submitted to the MACs, the Company has also recently submitted for peer reviewed publication its prospective, 36-month, multicenter GEMINI study to measure the long-term effectiveness and safety of the OMNI Surgical System used in combination with cataract surgery in patients with mild to moderate open-angle glaucoma. The Company believes this evidence showing sustained and durable IOP and medication reductions provides further confirmation of the clinical outcomes out to 3 years exceeding the 2-year data requirement in the LCD for the procedure to be determined reasonable and necessary. The Company expects this data to be published in the upcoming months.²

References:

1. Sight Sciences, Inc. Sight Sciences announces withdrawal of final lcds on micro-invasive glaucoma surgery from five Medicare administrative contractors. GlobeNewswire News Room. December 28, 2023. Accessed January 2, 2024. https://www.globenewswire.com/news-release/2023/12/28/2801733/0/en/Sight-Sciences-Announces-Withdrawal-of-Final-LCDs-on-Micro-Invasive-Glaucoma-Surgery-from-Five-Medicare-Administrative-Contractors.html.

2. Corporation I. Iridex Corporation Announces Successful Appeal for Revision of Recent Medicare LCDs to Provide Broader Coverage of Cyclophotocoagulation. GlobeNewswire News Room. Published November 27, 2023. Accessed November 28, 2023. https://www.globenewswire.com/news-release/2023/11/27/2786204/0/en/Iridex-Corporation-Announces-Successful-Appeal-for-Revision-of-Recent-Medicare-LCDs-to-Provide-Broader-Coverage-of-Cyclophotocoagulation.html