Serious threat to reimbursements for glaucoma procedures; deadline looms

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The movement to cut reimbursements and coverage for microinvasive glaucoma (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 to be considered investigational. These changes are scheduled to be implemented on December 24, 2023.

Background

Currently, there are 8 MACs nationwide within the Centers for Medicare and Medicaid Services that are regional providers for Medicare A and B claims in the US. The MACs meet together and individually to discuss and set coverage for different medical services/procedures, which can differ from region to region.

A meeting of all the MACs was convened in January 2023 to discuss among other topics goniotomy, which historically has been performed to treat pediatric and adult glaucoma cases. Within the last decade or so, the use of goniotomy in adults has expanded due to significant innovations in the safety and efficacy of the devices utilized to perform the procedure, which, with the expanded indication and claims, served as a red flag to the MACs, according to Michael Siegel, MD, FACS, a glaucoma specialist, and partner, Glaucoma Center of Michigan, and Co-Chief Glaucoma Service, Oakland University William Beaumont School of Medicine, Detroit, MI.

As a result, many of the MACs expanded upon this to look at the microinvasive glaucoma procedures as a whole resulting in major changes in a local coverage determination (LCD) proposal first by Wisconsin Physicians Services (WPS), a private corporation that covers Iowa, Kansas, Missouri, Nebraska, Indiana, and Michigan. Shortly following this action, most of the other regional MACs jumped on the bandwagon with similar LCD proposals.

There was no representation at the initial MAC meeting in January by the American Academy of Ophthalmology (AAO) and The American Glaucoma Society (AGS), nor were there any ophthalmologists on the committee deciding this coverage. It was not until June at the open WPS meeting that the AAO, AGS, industry representatives and independent, concerned physicians were allowed to present data regarding the potential changes to the insurance coverage. “This basically blindsided us…our society was kept in the dark until the very last minute and given little time to prepare a response…” Dr. Siegel stated.

WPS LCD proposal

Regarding MIGs, the stated coverage indications, limitations, and/or medical necessity are:

“To be considered reasonable and necessary current and future MIGS procedures/device must meet the following requirements:

• FDA approved.
• Demonstrated effectiveness of ≥20% or more reduction of intraocular pressure (IOP) on the same or reduced medication for duration of 24 months or longer demonstrated by moderate-high quality literature.

The literature defines the patient population who may best benefit from the procedure.

• Literature supports the new technology is at least equivalent to current treatment options.
• Literature supports low risk of serious adverse events.
• Literature supports that the surgery/procedure does not interfere with ability to perform definitive surgical management in future if indicated.
• New devices that offer the same or similar function must demonstrate they are equivalent (or superior) to existing devices with published peer-reviewed literature.”

The stated bottom line of the limits of coverage are as follows:

• The following are considered investigational in patients over the age of 18 for glaucoma management:
• Excimer laser trabeculostomy (i.e., ExTra ELT)
  • Viscocanaloplasty
  • Canaloplasty in combination with trabeculotomy ab interno (e.g., OMNI® Surgical) System)
  • Gonioscopy-assisted transluminal trabeculotomy (GATT)
  • Ab Interno Canaloplasty
  • Transcliary Fistulization
• MIGs is not considered a first line treatment for mild-moderate glaucoma.
• A combination of surgical MIGs procedure and aqueous shunts cannot be performed at the same time of service in the same patient.
• Phacoemulsification can be performed in conjunction with a single MIGS procedure (stent or surgical but not both at same time of service)

The final LCD document in its entirety can be viewed online.

Siegel’s arguments against this LCD are as follows:

• The proposed LCD as released, did not, as required, summarize the evidence that supports coverage, limited coverage, or non-coverage, did not provide a complete description of all items or services under review, and did not include a narrative that describes the scientific evidence supporting the clinical indications for all items or services.
• In the final LCD, WPS introduced a new 20% IOP reduction requirement for MIGS which they failed to present in the original proposed LCD. This became a key element of the final coverage framework and foreclosed the possibility for public comment on that requirement. The failure to allow discussion regarding this requirement is a process and protocol violation.
• From a clinical perspective, this new requirement fundamentally fails to consider the key goals of treatment in glaucoma patients. Instead of focusing on a rigid percentage reduction parameter, the primary goal for these MIGS procedures is often to stabilize patients' glaucoma using a procedure to achieve 24/7 stability, which often also reduces their need for costly, poorly tolerated medications that elderly patients often struggle to administer effectively.
• Labeling canaloplasty in combination with trabeculotomy ab interno (with devices such as Omni surgical system) as investigational is not supported by peer-reviewed medical evidence and clinical practice.
• Canaloplasty is a proven way to comprehensively reduce intraocular pressure, both as a freestanding procedure and in conjunction with cataract surgery. The procedure lets surgeons avoid more invasive surgery and avoid using shunts/implants that are riskier and have a poorer prognosis.
• The criteria for cyclophotocoagulation procedures use are heavily restrictive and make little sense from a patient care standpoint. The LCD limits Cyclophotocoagulation to patients with refractory glaucoma when they have failed trabeculectomy or tube shunt procedures and have minimal useful vision and elevated IOP and have no visual potential and need pain relief. It is common to see end stage patients with limited vision and pain who have not undergone trabeculectomy or tube shunt.
• Per WPS’s LCD criteria a surgeon would be required perform an aggressive high-risk procedure (trabeculectomy or tube shunt) on a low vision eye, when doing a low risk cycloablative laser to achieve pain control and IOP stability is less invasive and less expensive. No glaucoma surgeon should/would put their patients through an invasive filter in a low potential eye. We request a revisitation of this criteria to include patients who have failed extraocular aqueous drainage surgery (e.g., trabeculectomy or tube shunt) OR Limited visual potential OR who are poor candidates for incisional surgery OR who have exhausted all tolerated medications. [This change in language was ultimately achieved]
• The WPS LCD forces glaucoma surgeons to do more invasive incisional surgery in patients who can get IOP control or reduction of medication use by using a non-invasive, non-incisional laser.
• We agree that there needs to be a review of the procedures and appropriate guidelines developed for their utilization. We propose that WPS works with fellowship trained glaucoma specialists, the American Glaucoma Society, and the American Academy of Ophthalmology to create a properly educated task force to create proper guidelines for a future LCD.

Another view

Nathan Radcliffe, MDclinical associate professor of ophthalmology, New York Eye and Ear Infirmary of Mount Sinai and a surgeon at the New York Eye Surgery Center, expressed his views in a recent editorial in Ophthalmology Management.¹

Describing the WPS LCD as “seriously misguided,” he said, “it is likely the popularity and growth of these procedures that made them targets for possible cuts. “…we have the most backwards situation one could imagine: safer, newer, more cost effective and minimally invasive yet efficacious procedures became available, patients and surgeons flock to them, and Medicare wants to remove them, despite solid top-level evidence. It is worth noting that glaucoma afflicts Black and Hispanic patients, who often have more difficulty with access to medical care, with greater severity and frequency. These LCD cuts will disproportionally affect vulnerable populations and worsen health care disparities.”

Regarding goniotomy, he also pointed out that adult goniotomy has stronger literature support behind it, with more than 90 peer-reviewed publications, including a multicenter prospective randomized controlled trial, supporting safety and efficacy across a wide range of adult glaucoma. “This is level-one supporting evidence. “… it is unimaginable that Medicare would do such a cursory literature review that they missed the most important study in support of a surgical treatment,” he commented.

In addition, considering the extensive use of and evidence for the efficacy of cyclophotocoagulation since the 1980s, he concluded that the Medicare MAC administrators are uninformed.

Radcliffe urged physicians to become involved with national societies, AAO, American Glaucoma Society, or American Society of Cataract and Refractive Surgery and politicians to protect the treatment of glaucoma patients.

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.

While the future impact of this decision by the WPS and presumably other LCDs around the country remains unknown, both companies disagree with the WPS’s bottom line.

Iridex pointed out, “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.

The company “currently believes that the LCD will likely be interpreted to materially limit the patient types for which WPS will reimburse cyclophotocoagulation procedures after December 24, 2023…”

Regarding the requirements for cyclophotocoagulation to be considered medically reasonable and necessary, a positive action that occurred recently was that Iridex announced its successful advocacy for revision of the recently issued LCDs for cyclophotocoagulation.

As reported in Ophthalmology Times, Iridex reported thatthe 5 Medicare Administrative Contractors (MACs) that issued the new LCDs, all corrected errors in criteria for covering cyclophotocoagulationresulting in broader patient qualification in the jurisdictions of these MACs.²

Iridex President and CEO David Bruce said in a press release, “While we are pleased with this initial coverage-enhancing step, we are preparing a subsequent appeal to further broaden the patient criteria qualifying for reimbursement in these MAC jurisdictions. We will urge MAC administrators to include the additional recommendations from the 2001 AAO paper that remain excluded from the current modified LCD to cover (i) patients that are poor candidates for invasive surgical procedures and (ii) emergency situations. Our appeal will also seek proper consideration of the technological advances and the large body of peer-reviewed clinical studies supporting a broad range of patient types, disease severities, and safety evidence for CPC during the 22 years since the AAO paper and further broaden patient indications for coverage.” 2

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.

Michael Siegel, MD

He is partner/owner at Glaucoma Center of Michigan in Metro Detroit as well as Co-chief of the Glaucoma Service at Oakland University/William Beaumont School of Meidcine; he has no finaincial or proprietary conflicts in this subject matter.

Nathan Radcliffe, MD

He is clinical associate professor of ophthalmology, New York Eye and Ear Infirmary of Mount Sinai and a surgeon at the New York Eye Surgery Center.

References:

1. Radcliffe NM. From the Editor: Medicare contractors attack vulnerable glaucoma patients. Proposed changes encourage systematic inequality for glaucoma patients. Ophthalmology Management. 2023;27:5, 6.

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