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Response to Comments: Micro-Invasive Glaucoma Surgery (MIGS) Article

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Article ID
A59917
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Article Title
Response to Comments: Micro-Invasive Glaucoma Surgery (MIGS) Article
Article Type
Response to Comments
Original Effective Date
10/03/2024
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The comment period for the Micro-Invasive Glaucoma Surgery (MIGS) DL37531 Local Coverage Determination (LCD) began on 05/30/24 and ended on 07/14/24. The notice period for L37531 begins on 10/03/24 and will become effective on 11/17/24.

The comments below were received during the Open Comment period by Palmetto GBA, CGS, NGS, Noridian, and WPS. Responses to these comments are provided in this article..

Response To Comments

Number Comment Response
1

A comment letter was jointly written by American Academy of Ophthalmology (The Academy), American Glaucoma Society (AGS), American Society of Cataract and Refractive Surgery (ASCRS), and Outpatient Ophthalmic Surgery Society (OOSS). They express overall support of the Proposed policy: “The iterative public comment process has resulted in a proposed LCD which overall reflects current practice patterns and allows for the physician and patient to come to treatment decisions that work best for that unique patient. We also appreciate the added section on health care disparities in the policy, which recognizes the disproportionate disease burden of glaucoma on minorities, particularly African Americans and Latinos. Our organizations agree that more research is needed to better understand demographic differences in treatment and that future research must include more diverse study populations.”

The following additional recommendations are made “We support coverage for one trabecular aqueous stent device per eye when performed in conjunction with phacoemulsification/intraocular lens placement (i.e., cataract surgery) and coverage for one subconjunctival space stent or trabecular aqueous stent device for the management of refractory glaucoma. While phacoemulsification/intraocular lens placement with a single MIGS procedure is indicated as covered in the limitations of coverage section, for clarity we think it makes more sense to include it in the Indications of Coverage section. Our organizations request that the MAC include a third coverage indication in the final LCD confirming that phacoemulsification/intraocular lens placement can be performed with a single MIGS. The proposed LCD does not provide coverage for phacoemulsification/intraocular lens placement performed with a combination of MIGS procedures (e.g., cataract + stent + canaloplasty or goniotomy) at the same time of service in the same eye. Although we understand why this limitation is in the policy at this time, our organizations call your attention to the growing body of evidence that shows improved outcomes and patient experience when MIGS procedures are combined. A 2023 study by Dickinson, et el. found significantly greater reduction in glaucoma medications while maintaining similar rates of intraocular pressure reduction and low complications when cataract surgery was combined with microstent and canaloplasty compared to cataract surgery and microstent alone.”

Dickinson 2023 reference is submitted. They request case by case coverage of phacoemulsification/intraocular lens placement with more than one MIGS procedure. Editorial changes are recommended as well.

Thank you for your comments and overall support of the policy. Recommended editorial changes have been made throughout the policy. Additional literature was submitted and added to the LCD.

The LCD allows phacoemulsification/intraocular lens placement to be performed with a single MIGS procedure. This clarification has been made in the LCD. There is not sufficient evidence to support the combination of phacoemulsification with multiple MIGS procedures in the same eye at the same time of service. The supporting literature has been added to the LCD but is limited to retrospective studies, short term follow-up, small sample sizes, incomplete data, risk of bias and multiple other factors discussed in the LCD that limit the reliability of these reports. Case by case coverage would not be appropriate as this is currently experimental and does not meet the definition of reasonable and necessary for Medicare coverage. We look forward to future research in this area and additional evidence is developed it can be submitted through the LCD reconsideration process.
2

A comment letter was received from Sight Sciences with support of the proposed policy stating: “We appreciate that the proposed LCD is carefully tailored to assess the evidence supporting reasonable and necessary uses of trabecular aqueous stent devices.” They encourage MACs to “work closely with surgeons, specialty societies, patient advocates, and technology companies to ensure that Medicare policies support beneficiary access to safe, minimally invasive glaucoma surgical procedures, like the comprehensive aqueous outflow restoration procedure enabled by OMNI technology developed by Sight Sciences, to preserve sight for these patients.” They encourage inclusion of real-world results in evidence analysis explaining “The American Academy of Ophthalmology’s IRIS registry (Intelligent Research in Sight), is the largest specialty society clinical data registry in all of medicine and provides large scale “real world” evidence on the safety, IOP lowering efficacy, glaucoma medication reducing efficacy, and treatment durability of many MIGS procedures, including those performed using OMNI.”

Thank you for your comments and support of the proposed policy.
3

A comment letter from New World Medical (NWM), maker of several devices used in the treatment of glaucoma comments: “We support the Medical Directors proposed LCD in general, and specifically endorse the adopted definitions of canaloplasty and goniotomy. We request one addition, specifically, to be consistent with the citation found at the end of the goniotomy definition, at the end of the canaloplasty definition we suggest the addition of a citation to the American Academy of Ophthalmology page found at https://www.aao.org/practice-management/news-detail/canaloplasty (see Appendix A - showing identical language as in proposed LCD).”

Thank you for your comment and support of the policy. The citation which has been added to the policy.
4

A comment letter from AbbVie request correction of supraconjuctival to subconjunctival in the indication for coverage section.

Thank you for commenting this typographical error has been corrected.
5

A comment letter from Alcon is received and states: “Alcon urges the MACs to finalize its proposed determination that one trabecular aqueous stent device per eye which is approved for the treatment of adults with mild or moderate open-angle glaucoma (OAG) and a cataract when the individual is currently being treated with an ocular hypotensive medication and the procedure is being performed in conjunction with cataract surgery is reasonable and necessary. Alcon, however, is concerned that CGS’ proposal to non-cover multiple procedures on the same eye in the same day will unnecessarily limit physician treatment choices thereby harming beneficiaries.”

The letter explains the complexity of glaucoma often requiring a combination of pharmacological and surgical intervention. They elaborate “Alcon urges CGS and the other MACs to revise the Proposed LCD to be inclusive of procedures without restricting diagnoses and disease stages across the procedures being offered. Specifically, we urge the MACs to permit multiple procedures on the same eye in the same day.”

They explain scientific societies support access to new innovation to safely improve patient outcomes and preserve sites and “Alcon supports the position statements submitted by the American Academy of Ophthalmology, the American Glaucoma Society, and the American Society of Cataract and Refractive Surgery that preserve physician choice.”

In conclusion they summarize: “Alcon believes medical policies need to be reflective of current and emerging treatment patterns, guided by clinical evidence and support of the scientific societies. ECPs must have the ability to make individualized treatment recommendations to best manage disease progression and minimize the threat of blindness in their patients. We appreciate consideration of Alcon’s perspectives and re-evaluation of the proposed LCD.”

Thank you for your comments. No additional literature was submitted with these comments. While we understand the importance of multiple treatment options in a complex condition such as glaucoma to be eligible for coverage the service must meet the definition of reasonable and necessary as defined by the Social Security Act. This requires demonstration of efficacy and improved outcomes for Medicare beneficiaries. There is not sufficient evidence to support multiple procedures in the same eye on the same day beyond what is already covered in the LCD. If such evidence is developed it can be submitted through the LCD reconsideration process.
6

A comment letter was received from a provider to NGS with overall support of the LCD. The author comments:

  1. To correct error “supraconjunctival”
  2. The header “Studies that compare IStent to surgical MIGS” is confusing. iStent is a “surgical MIGS” procedure. Either the intent is to compare iStent to other “MIGS procedures” or iStent and other stents to excisional angle procedures – goniotomy.
  3. In my opinion we should dump the term “MIGS” = not a good term that lumps together procedures which are not similar … and adopt more specific terms” with suggestions.
  4. I agree with using caution before covering multiple angle procedures – no good evidence for doing angle stents and goniotomy or angle stents and aqueous shunting and also does not seem like a logical combination for some combinations and can be a really good way of driving up costs if not regulated.
  5. I agree that Xen should be performed by ophthalmologists with experience in bleb management since much of success involves having some experience.
  6. We need to make Xen coverable for angle closure glaucomas. We do trabeculectomy for angle closure glaucomas and should have access to Xen for these.

Thank you for your comments and support of the policy.

  1. The typographical error was corrected to intended subconjunctival.
  2. The header was changed to “Studies that compare iStent to excisional angle procedures”.
  3. We appreciate the term MIGS is not specific but since this is what is utilized in the current literature and societal guidance and therefore, retained in the policy. We agree; however, further clarification from the societies in the future may be beneficial.
  4. We appreciate your concern and agreement with the limitations on multiple procedures.
  5. We agree that Xen should be performed by ophthalmologists with experience with bleb management.

If evidence is developed demonstrating efficacy and improved outcome for XEN for angle closure glaucoma it can be submitted for expansion to coverage via the LCD reconsideration process.
7

A comment letter was received from Glaukos stating “Glaukos is appreciative of the detailed evidence review conducted by the MACs and we are supportive of the Proposed LCD and Draft Article as it relates to our December 2022 LCD Reconsideration Request associated with iStent infinite®. We believe that, upon finalization, the coverage policy will further facilitate Medicare beneficiary access to high quality products and services to treat their sight threatening glaucoma disease.”

They have additional recommendations as follows:

  1. Correction of typographical error supra -> subconjunctival and some additional editorial corrections.
  2. They recommend “Revise the third numbered item in the Limitations of Coverage to clarify the scope of the limitation so that it applies to the types of multiple MIGS procedures that are discussed in the Proposed LCD.
  3. Submission of new literature (Neuhann et al. 2024).
  4. Recommendations for the B&C Article “The Draft Article includes a section entitled “Multiple Procedure Limitations” that indicates that “reporting of a combination of MIGS procedures (other than phacoemulsification) at the same time of service in the same patient risks denial of the entire claim. A combination of services is more than 1 device or surgical technique applied at the same time.” This language is not consistent with the Proposed LCD and must be revised. As noted in Section I(C) above, we are concerned that the language might be misinterpreted to prevent coverage of multiple procedures like a cataract procedure and the insertion of an iStent. We do not see this as the MACs’ intent, but if a reader focused on the language about a combination of services being more than one surgical technique, the reader might misapprehend the intent.”

Thank you for your comments and support of the Proposed Policy. The typographical and editorial corrections have been made. The LCD language has been clarified that phacoemulsification can be performed with a single MIGS procedure (see Comment #1) in the LCD and B&C Article. The long-term data on iStent with cataract by Neuhann et al. was added to the LCD.
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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L37531 - Micro-Invasive Glaucoma Surgery (MIGS)
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  • MIGS

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