Throughout 2024, we kept a close eye on several Medicare administrative contractors (MACs) for policy updates regarding microinvasive glaucoma surgery (MIGS). On
November 17, five MACs—Palmetto,1 NGS,2 CGS,3 Noridian,4 and WPS5—implemented updated local coverage determinations (LCDs) and local coverage articles (LCAs) for MIGS. The policy updates provide revised coverage guidance and limitations, coding
guidance, and procedure limitations. Meanwhile, two MACs, Novitas6 and First Coast,7 did not take part in the revision process, leaving their current policies unchanged.
The process began in early 2023, when the five MACs met to discuss MIGS coverage.8 Together, they developed policies outlining coverage guidelines for MIGS. However, after publishing the final policies in late 2023, the MACs received significant feedback from ophthalmic societies and physicians, which led to the retirement of the 2023 LCDs before they could take effect. In 2024, the five MACs restarted the process, and after months of discussion, the revised policies took effect in November 2024.
Commercial payers are also reviewing their policies. Cigna9 and Aetna10 reviewed their policies in late 2024, and are slated for additional reviews in early 2025. United Healthcare11 updated its glaucoma surgery policy in January 2025.
Indications, Limitations
First, the updated policies specify that “MIGS is not considered a first-line treatment for mild-moderate glaucoma.”5 Instead, the policies reference AAO guidelines describing laser trabeculoplasty and drops as first-line treatment.
Second, the updated policies provide clarity on coverage for multiple MIGS procedures performed during a single session. According to the LCDs,2 cataract surgery combined with one MIGS procedure is covered: “Phacoemulsification/intraocular lens placement can be performed with a single MIGS procedure.” Additionally, the five MACs address specific combinations as follows:
“Phacoemulsification/intraocular lens placement performed with a MIGS procedure combination (e.g., cataract + stent + canaloplasty or goniotomy) on the same eye, at the same time, is non-covered and risks denial of the entire claim.” 4
The MACs further addressed the issue of multiple MIGS in a single session in their responses to the comments received during the policy development process. Specifically, the AAO, American Glaucoma Society, American Society of Cataract and Refractive Surgery, and Outpatient Ophthalmic Surgery Society advocated for case-by-case coverage of phacoemulsification/IOL placement with multiple MIGS procedures. However, the MACs rejected this request: “Case by case coverage would not be appropriate, as this is currently experimental and does not meet Medicare’s criteria for reasonable and necessary coverage.” 12
This response indicates that the MACs will restrict coverage to a single MIGS procedure per session. Claims involving multiple MIGS procedures are likely to result in denial of one or all of the procedures listed on the claim. Beyond specifying “non-coverage,” the updated policies provide no further guidance on this issue.
Finally, many commercial payers have their own MIGS coverage policies, which can differ significantly from Medicare’s policies. For example, United Healthcare only covers “Goniotomy or trabeculotomy for pediatric glaucoma (age 18 years or less).”11 In contrast, the revised LCDs impose no age restrictions for goniotomy.
Medical Necessity Documentation
Proper documentation of the patient’s compliance with ocular hypotensive medications is essential. The revised LCDs1 describe coverage for patients on ocular hypotensive medication and those on maximum tolerated medical therapy (MTMT). Given the new restriction against using MIGS as a first-line treatment for mild to moderate glaucoma, establishing and documenting medical necessity is critical. Research highlights widespread challenges with drop compliance. One study found that only 10% of participants had their medication continuously available.13 Another study reported “very good adherence” in just 20% of patients over one year and 15% over four years.14
Additionally, a separate study revealed that 50% of glaucoma patients struggle to follow their prescribed drop regimens, citing factors such as complex dosing schedules, physical limitations, or financial constraints.15
The summary of evidence in the revised policies clarifies when the MACs consider surgical care appropriate. “When the maximum tolerated medical therapy fails to control progression of glaucomatous optic neuropathy, surgical care is considered the next treatment option.” 3 Furthermore, the LCD reflects that MTMT is unique to each patient by summarizing the AAO Preferred Practice Pattern for Primary Open Angle Glaucoma16 in stating: “the effectiveness, potential side effects, tolerance of medications, and desired target IOP must all be balanced for each individual patient when choosing a regimen best suited for that patient, whether medical or surgical.” 3
Considering the revised guidelines, the chart documentation should clearly support medical necessity for recommending MIGS. In our experience, we often see acceptable documentation about severe non-compliance with drops (eg, no drops used since last visit). However, practices do not consistently document routine or occasional non-compliance with drops. To further support medical necessity for a MIGS procedure, consider going beyond the standard indications of elevated IOP, visual field progression and nerve fiber layer loss. Incorporate patient-specific factors, such as medication compliance, affordability, and tolerance. Customizing documentation to reflect each patient’s unique situation can strengthen the case for surgical intervention.
Manufacturers’ Instructions for Use and Medical Necessity Requirements
Both the MACs and commercial payers are aware of the indications outlined in the manufacturers’ Instructions for Use (IFUs). However, payer guidelines do not always align with indications listed in the IFUs. For example, the indications for both Glaukos’ iStent inject and Alcon’s Hydrus Microstent state, “indicated for use in conjunction with cataract surgery for the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG).”17,18 The updated MAC policies take it one step further to include that the patient is “currently being treated with an ocular hypotensive medication.”4
Going forward
As the volume of MIGS procedures continues to grow, the MACs have been diligently working to establish policies to keep pace with expanding technology and surgical advancements. Moving forward, maintaining robust chart documentation is crucial to demonstrate medical necessity. Additionally, gaining a thorough understanding of the specific details for both MAC and third-party payer policies is essential for ensuring coverage and reimbursement. OM
REFERENCES
1. Palmetto GBA Local Coverage Determination L37531 Micro-Invasive Glaucoma Surgery (MIGS) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37531&ver=20&keywordtype=starts&keyword=migs&bc=0 Last accessed December 27, 2024
2. National Government Services, Inc. Local Coverage Determination L37244 Micro-Invasive Glaucoma Surgery (MIGS) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37244&ver=39&keywordtype=starts&keyword=migs&bc=0 Last accessed December 27, 2024
3. CGS Administrators, LLC Local Coverage Determination L37578 Mico-Invasive Glaucoma Surgery (MIGS) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=37578&ver=27&keywordtype=starts&keyword=migs&bc=0 Last accessed December 27, 2024
4. Noridian Healthcare Solutions, LLC Local Coverage Determination L38301 Micro-Invasive Glaucoma Surgery (MIGS) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38301&ver=22&keywordtype=starts&keyword=migs&bc=0 Last accessed December 27, 2024
5. Wisconsin Physicians Service Insurance Corporation Local Coverage Determination L39907 Micro-Invasive Glaucoma Surgery (MIGS) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39907&ver=3&keywordtype=starts&keyword=migs&bc=0 Last accessed December 27, 2024
6. Novitas Solutions, Inc. Local Coverage Determination L38223 Micro-Invasive Glaucoma Surgery (MIGS) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38223&ver=19&keywordtype=starts&keyword=migs&bc=0 Last accessed December 27, 2024
7. First Coast Service Options, Inc. Local Coverage Determination L38233 Micro-Invasive Glaucoma Surgery (MIGS) https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=38233&ver=6&keywordtype=starts&keyword=migs&bc=0 Last accessed December 27, 2024
8. Palmetto GBA Multi-Jurisdictional Micro-Invasive Glaucoma Surgery Contractor Advisory Committee Meeting: January 5, 2023 https://www.palmettogba.com/palmetto/jma.nsf/DIDC/WTLDTTNJOA~Medical%20Policies~LCD%20Development%20Meetings Last accessed January 6, 2025
9. Cigna Healthcare Glaucoma Surgical Procedures Coverage Policy Number 0035 https://static.cigna.com/assets/chcp/pdf/coveragePolicies/medical/mm_0035_coveragepositioncriteria_viscocanolostomy.pdf Last accessed December 27, 2024
10. Aetna Glaucoma Surgery Number: 0484 https://www.aetna.com/cpb/medical/data/400_499/0484.html Last accessed December 27, 2024
11. United Healthcare Glaucoma Surgical Treatments Policy Number: 2025T0443II https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/glaucoma-surgical-treatments.pdf Last accessed January 6, 2025
12. CGS A59910 Response to Comments: Micro-Invasive Glaucoma Surgery (MIGS) https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59910&ver=4 Last accessed December 27, 2024
13. National Library of Medicine Using Pharmacy Claims Data to Study Adherence to Glaucoma Medications https://pubmed.ncbi.nlm.nih.gov/17962457/ Last accessed December 27, 2024
14. National Library of Medicine Patterns of Glaucoma Medication Adherence over Four Years of Follow-Up https://pmc.ncbi.nlm.nih.gov/articles/PMC4581955/ Last accessed December 27, 2024
15. National Library of Medicine Adherence to Therapy in Glaucoma Treatment – Review https://pmc.ncbi.nlm.nih.gov/articles/PMC9032050/ Last accessed December 27, 2024
16. American Academy of Ophthalmology. Primary Open Angle Glaucoma PPP 2020. https://www.aao.org/education/preferred-practice-pattern/primary-open-angle-glaucoma-ppp Last accessed January 21, 2025
17. Glaukos iStent inject W Trabecular Micro-Bypass System Instructions for Use https://www.glaukos.com/wp-content/uploads/2021/09/45-0244-Rev-1-artwork-IFU-G2-W-iStent-inject-W-Commercial-US.pdf Last accessed December 27, 2024
18. IIvantis Hydrus Microstent Instructions for Use https://www.accessdata.fda.gov/cdrh_docs/pdf17/P170034D.pdf Last accessed December 27, 2024
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