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

The American Glaucoma Society request coverage for standalone trabecular stents and goniotomy. References are submitted with their comments. They submit the following comments:

Trabecular stents are very safe providing a safer option with less potential for complications than traditional glaucoma surgeries. Trabecular stents result in clinically significant and durable lowering of IOP which improves patient health outcomes by reducing the rate of visual field progression. They are cost effective when compared to medication alone and provide an alternative for patients who are struggling with adherence to medication and reduce medication burden.

Goniotomy (previously referred to as ab interno trabeculotomy) provides long term reduction in IOP and in medications. A randomized controlled trial comparing goniotomy to trabecular stents at the time of cataract surgery demonstrates equivalent reduction in IOP and medications.

Thank you for your comments and the submitted supporting literature. We agree with the role of trabecular stents and that there is supporting evidence for their use as standalone procedure in select patients. Additionally, we have reviewed additional literature regarding goniotomy and have expanded coverage for goniotomy for appropriate patients within the LCD.

Comments were submitted by Elios Vision, Inc makers of the device used in excimer laser ab interno trabeculostomy represented by CPT^® 0621T (trabeculostomy ab interno by laser) and 0622T (trabeculostomy ab interno by laser, with use of ophthalmic endoscope). The commenter states the ELIOS device has been used safely in Europe for a decade. They are seeking FDA approval in United States and are anticipating results from a study in 2024. Studies in ELT were submitted.

They explain ELT has a unique CPT^® code assigned and should not be billed with CPT^® 66999 but 0621T or 0622T and should not be billed with 0730T.

Thank you for your comments. If FDA approval is obtained, this product can be considered through the LCD reconsideration process. The level of evidence we are seeking is summarized in the coverage section of the LCD for transparency. We agree with the billing and coding information submitted and changes have been made to the related B&C article.

Multiple providers and state societies submitted similar letters that share concerns over the LCD stating, “that excisional goniotomy (with the Kahook Dual Blade or Trabectome), viscocanaloplasty, canaloplasty with trabeculotomy ab interno (OMNI system), gonioscopic-assisted transluminal trabeculotomy (GATT), ab interno canaloplasty (ABiC), and cyclophotocoagulation should not be considered investigational for patients over 18 years of age.” They state this decision disregards 10 years of research and clinical experience. They express concern that only covering stents and bleb forming procedures will limit the options available to patients. They state the rapid increase in utilization of these procedures is due to their improved safety profile and improved vision recovery compared to traditional glaucoma surgery.

They state the Ocular Hypertension Study demonstrates that progression to glaucoma at 5 years was cut in half with a reduction in IOP of 22.5% in patients with elevated IOP. The Early Manifest Glaucoma treatment trials similarly demonstrated that glaucoma progression was reduced in half with IOP reduction of 25% in patients with newly diagnosed glaucoma. They state the Advanced Glaucoma Intervention study demonstrates patients with severe glaucoma did not experience progressive visual field loss if their average IOP was 14mmHg and never over 17mmHG over the course of a 10 year follow up. They state reduction and stabilization of IOP is the current consensus target in the management of glaucoma. They agree there are a few randomized trials designed to compare the efficacy amongst these procedures but there is evidence of IOP reduction. They respectively encourage the LCD to reconsider the listings of these procedures as they do not agree that they are investigational.

See Comment #1. Thank you for your comments and summary of literature related to IOP and glaucoma management. We agree that IOP has been the primary marker in glaucoma studies to date. One of the challenges within the MIGs literature, as outlined in the Analysis of Evidence section of the LCD, is that few of the published studies do not have defined primary endpoints and in those that do, the endpoint is a reduction in glaucoma of ≥20% reduction in IOP or a reduction in medication. The percentage of patients achieving reduction in the range necessary for reduction in disease progression has not been reported. These procedures also reduce IOP to the mid-teens but reduction beyond the mid-teens is not consistent and therefore, it is uncertain if this is sufficient to reduce progression of glaucoma. The short-term follow-up for these studies has not provided sufficient duration of time to understand the impact these procedures offer for reduction of visual field loss. The overall body of literature is low quality largely consisting of case reports, case series and retrospective reviews with a lack of randomized controlled trials that will more definitively provide understanding of the impact these procedures have on site as well as comparative studies to understand which procedures may be best suited to achieve these goals. In order to establish a transparent process for evaluation of the literature a minimum criterion for evidence has been added to the LCD.

Sight Science, Inc, manufacturer of the OMNI Surgical System submitted the following comments. They state the Omni procedure can be performed alone or with cataract surgery for mild-moderate or advanced glaucoma and is well described in the clinical literature. Several large studies have shown the OMNI procedure lowers IOP significantly as well as reduces the need for medication. They state that the OMNI also reduces risk associated with more invasive surgical options. They expressed concern that this would deprive patients from access to a safe and minimally invasive procedure and force patients to more invasive surgeries as well as limit treatment options. They expressed concern that the proposed LCD only cited 3 of 18 publications for the OMNI procedure. They explained that based on the ROMEO trial, OMNI was granted expanded FDA label, and the results of the prospective GEMINI trial were recently published. They state the procedure is recognized in AAO and AGS guidelines. They request more opportunity for subject matter experts to input on the proposed LCD.

Thank you for submission of supporting literature for the OMNI procedure. At this time endpoints greater than 12 months have not been reported for the OMNI system outside of retrospective and low-quality literature. There is low-quality literature regarding the transluminal viscodilation of Schlemm’s canal as in independent procedure and uncertainty on outcomes. It is unclear if the benefits from OMNI seen in the literature thus far is related to the combination procedure or trabeculotomy portion alone. There are no comparison studies to understand the impact of the combined procedures. The prospective GEMINI trial has published 12-month data and is ongoing to obtain determined durability of the procedure. Since there are no other devices that combine these two procedures reported, outcome and safety data of at least 24 months is important to better understand the impact and/or risk associated with this procedure. When additional peer reviewed published literature has been obtained that demonstrates efficacy and durability this can be considered through the LCD reconsideration process.

The AAO Preferred Practice Guidelines states Gonioscopy-assisted transluminal trabeculotomy involving ab interno 360 cannulization of Schlemm’s canal with an illuminated microcatheter or suture followed by trabeculotomy, appears to be reasonably efficacious but data are limited, and additional studies are needed. The report states that the OMNI surgical system is an alternative means of performing 180-to-360-degree ab interno trabeculotomy using retractable microcatheter. The Guideline does not state support or non-support of the system.

In addition to the CAC meeting, the proposed LCD is visible to the public with opportunity for stakeholders to present during the open comment period and submit comments to gain additional subject matter input through the LCD process. Approximately 260 articles were reviewed as part of this process to ensure adequate assessment of the literature before the final policy was developed.

Multiple providers submitted letters requesting coverage for goniotomy. They state that there is published clinical data and clinical experience of more than 10 years using MIGS including goniotomy to treat glaucoma. Additionally, a series of letters were submitted in support of goniotomy with a list of supporting literature for this procedure.

Thank you for your comments. Additional literature has been submitted through the open comment process and added to the evidence section of the LCD. Based on this, minimum criterion for coverage has been created to provide transparency on the quality of evidence we are seeking for coverage. This has allowed expansion of coverage to goniotomy for appropriately selected patients.

Multiple providers submitted letters requesting coverage for canaloplasty. Additionally, a series of letters were submitted with support for OMNI system.

Thank you for your comments. Additional literature has been submitted through the open comment process and added to the evidence section of the LCD. Within the Analysis of Evidence, the concerns regarding the literature support canaloplasty are reviewed which is challenged by a lack of moderate or high-quality evidence, and short-term follow. A minimum criterion for coverage has been created to provide transparency on the quality of evidence we are seeking for coverage. If additional literature is published in peer reviewed journals to support canaloplasty this can be submitted through the LCD reconsideration process.

Multiple commenters state that these devices are all FDA approved and therefore, not investigational.

FDA approval does not mean a product meets the reasonable and medically necessary definition for Medicare. For a service to be considered “reasonable and necessary” under §1862(a)(1)(A) of the Act it must be furnished in accordance with acceptable standard medical practice for the diagnosis or treatment of the condition. (Title XVIII of the Social Security Act: Sec. 1861.(s)(2) Part E—Miscellaneous Provisions: De?nitions of Services 2021) To meet this requirement, an intervention must be established and supported by medical literature and cannot be considered experimental or investigational. In this case, there is insufficient evidence to support clear standards for patient selection, established benefit of these procedures over standard of care and how they improve health outcomes for beneficiaries, therefore they do not meet these criteria. Without sufficient evidence to support these procedures they are considered investigational.

Multiple comments state that the LCD that not allowing access to these procedures will result in loss of sight.

The current literature has not demonstrated that these procedures are associated with preservation of sight or slower progression of vision loss. It is understood reducing IOP by >22.5% (Ocular Hypertension Study) can significantly reduce progression of glaucoma. These procedures are not consistent in their ability to reduce IOP by that amount, since IOP reduction is in mid-teens, and it is uncertain if that is sufficient for long term reduction. Additionally, no studies have longitudinally measured the impact on vision as a marker of success and there is a lack of long-term data to understand the impact of these procedures. Given the early promising results there are likely patient populations that will benefit from these procedures and further investigations to identify those populations are necessary as well as comparative studies to understand how these procedures compare to standard of care as well as to each other.

A comment submitted additional literature on the KDB blade stating there are over 90 published peer reviewed papers and 1 prospective RCT on KDB goniotomy.

Thank you for providing supporting literature. The LCD did not include case reports, case series and small retrospective reports in the evidence review. The remaining submitted literature has been added to the LCD. Additionally, we have developed a foundational LCD with a more transparent level of evidence for consideration of technologies where a minimum criterion for coverage for consideration has been added to the LCD. Based on this additional evaluation coverage has been expanded to include goniotomy in appropriately selected patients.

A commenter expresses concern over the impact of the LCD for underserved areas where they practice. Access to specialists is limited for patients unable to travel and they feel the OMNI system offers reduction in IOP that they may not be able to access otherwise.

We understand the importance of access to care and agree with the importance of novel technologies that are medically necessary being accessible regardless of geographic location. However, it is also essential that these technologies are proven by evidence to improve outcomes for patients. Early investigation with the OMNI device appears promising but the studies are largely low quality. The single prospective study reports only short-term outcomes to date. If future investigation demonstrates longer term benefits this can be reconsidered through LCD reconsideration process. In the interim, there are multiple procedures that remain covered in addition to medical management.

Microsurgical Technologies expresses concerns with non-coverage of goniotomy stating this is a long standing procedure and an important part of their practice for glaucoma management. They list 138 references in support of goniotomy. They state the AAO guidance concludes the ab interno approach is significantly effective and does not carry the same risk profile as traditional glaucoma surgery. They expressed concern with the CPT^® code recommendation of 66999 and recommend CPT^® code 65820 be utilized for goniotomy consistent with AMA guidance. They also state that because it has a CPT^® code, it should be covered. They state that some surgeons are billing goniotomy when they are only making punctures into the trabecular mesh work which is not meeting the definition of goniotomy, and the LCD should clarify that. They also state at least 1 private payer covers goniotomy.

Thank you for your comments. See Comment #5. We agree with the importance of a clear definition for goniotomy to ensure correct billing and coding which has been added to the LCD. The related Billing and Coding article did state using code 65820 for goniotomy consistent with AMA definition and distinguish this from procedures that do not meet this definition that should be billed under CPT^® 66999. These sections have been separated and goniotomy removed from the 66999 list to avoid confusion. A CPT^® code does not equal coverage as the service must still meet the definition of medically reasonable and necessary.

Multiple providers comment with concerns on the LCD and state the importance of cyclophotocoagulation, stating advances in these technologies has allowed improved safety and broader applications. They explain “traditional photocoagulation has been clinically used for the management of refractory glaucoma for nearly 30 years and is often the only and safest option for patients with complex ophthalmic histories and advanced glaucoma. Removing the cyclophotocoagulation option from our surgical toolbox will significantly affect those with the most advanced glaucoma, leaving them the options of losing their vision, living with pain, or removal of the eye.” They also address concerns regarding health care disparities.

Based on input from subject matter experts and additional literature that was reviewed, a limited coverage for cyclophotocoagulation has been added to the LCD in cases where there are not alternative treatment options to ensure access to care for Medicare beneficiaries. A section has been added to the LCD that addresses health care disparities.

Multiple state medical societies submitted comments requesting the procedures under non-coverage be covered. They state more than 10 years’ experience in MIGS procedures with published literature. They expressed concern with healthcare disparities. They appreciate standalone coverage for trabecular stents under CPT ^® 0671T. They request coverage for MIGs procedures to avoid more invasive procedures such as trabeculectomy and tube shunts. They explain the value of cyclophotocoagulation to their services.

Thank you for your comments. See Comments 1, 3, 4, 6, and 12.

Several societies jointly submitted a letter expressing concern about the classification of goniotomy or ab interno trabecular bypass surgery, canaloplasty in combination with trabeculotomy ab interno, gonioscopy-assisted transluminal trabeculotomy, ab Interno canaloplasty and cyclophotocoagulation is expressed. They explained the challenges some patients have in use of eye drops for medical management. They explained the importance of MIGS procedures for glaucoma management (even in patients with IOP less than 21) providing more consistent IOP control than medication with fewer peaks and valleys in pressure. They also state the importance of cyclophotocoagulation and micro pulse delivery for patients who are poor candidates for incisional eye surgery or have limited visual potential. They express thank you for standalone coverage for trabecular stents under CPT^® 0671T. Supporting literature has been provided with these comments.

Thank you for your comments and supporting literature.

While we understand and agree that some patients are challenged with medical management literature to show that peak and troughs related to eye drops has not been provided that demonstrates this impacts disease progression or is an indication for surgical management. Studies do show that optimal medical management has successfully reduced IOP over long durations of time.

Additionally, long-term outcome of MIGS procedures has yet to be determined with most of the literature limited by short term follow-up and the primary outcome measurements have not included values that can measure disease progression and the impact of these procedures on sight.

There are many shortcomings within the body of literature to support MIGS including:

• largely retrospective study designs with resultant low-quality evidence
• many studies do not have defined primary endpoints
• it is not clear the impact of reduction of IOP into the mid-teens on the progression of glaucoma over time
• studies have not addressed the degree of IOP reduction necessary to reduce disease progression for mild to moderate glaucoma especially in those with baseline IOP <21 mmHg
• studies do not measure visual fields and impact on sight over time
• few studies measure the need for additional surgical interventions in the future
• few studies compare surgical procedures to each other
• studies have mixed inclusion populations, and it is not clear which procedures provide optimal benefit for different types of glaucoma and baseline level of disease
• many studies have potential risk of bias
• few studies have been conducted in a diverse population or populations that represent the burden of disease in the population
• while the preliminary data on these procedures appear to be safe, long-term safety data has not yet been developed, nor the impact of multiple procedures in the same eye over time

We strive to ensure new technologies are medically reasonable and necessary for the Medicare beneficiaries, while still fostering innovation and progress in disease management. For this reason, the LCD has been changed to a foundational format with a more transparent level of evidence for consideration of technologies with a minimum criterion for coverage for consideration which has been added to the LCD. Coverage has been expanded to include goniotomy, which meets the minimum criteria outlined within the LCD for coverage as well as additional limited coverage criteria for cyclophotocoagulation. The other requested technologies fall short of the minimum criteria and additional literature is necessary for further consideration of these technologies. As additional literature is developed this can be submitted through the LCD reconsideration process.

Comments were received from GLAUKOS with support for coverage decision to expand coverage for iStent infinite^® as a standalone trabecular stent. They request the following:

• Individual consideration rather than non-coverage for the use of the iStent^®, iStent inject^®, and iStent inject^® W devices outside of adults with mild or moderate open-angle glaucoma and a cataract when the individual is being treated with an ocular hypotensive medication and the procedure is being performed with cataract surgery
• To clarify that the stent placement is intended to be per date of service
• To add the iStent infinite^® studies (specifically Sarkisian) to the pivotal trials table from the original MIGS policy
• Add published literature on use of the iAccess^™ device and revise the location of this information to the Ab interno trabeculectomy section of the LCD.
• Assign the same International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes to Groups 1 and 3, as Group 2, so all 3 groups have the same diagnosis codes
• Revise the information on coding for procedures using the iPRIME™ device to clarify that CPT^® code 66174 is an appropriate procedure code

Thank you for support of the expansion of the LCD to iStent infinite^®. Additionally, the LCD has been changed to a foundational policy setting a criterion for coverage for evaluation of future devices.

iStent^®, iStent inject^®, and iStent inject^® W are FDA indicated for mild to moderate open angle glaucoma and cataract surgery and supported by evidence. There is not sufficient evidence to allow off-label use and therefore, remains non-covered. If additional evidence is developed this can be submitted through the LCD reconsideration process.

Date of service has been added to the related Billing and Coding article to clarify correct coding.

The 2023 Sarkisian study was included in the LCD in a separate section titled “Stent placement without cataract surgery”. We feel that this is the more appropriate location for this evidence to be reviewed than the pivotal trial table which was limited to studies available at the time of the original LCD. All new literature has been added as text since that time.

Supporting literature was not provided regarding the iAccess^® and iPrime™ devices and will need to be submitted to determine if it meets the criteria for coverage outlined in the LCD.

Group 1 codes are consistent with the LCD’s coverage of the Group 1 CPT^® codes for mild-moderate open angle glaucoma. The use of these codes outside of these indications is not considered reasonable and necessary, therefore no changes will be made to the related Billing and Coding article.

The Billing and Coding article has been updated to reflect the CPT^® code 66174 for canaloplasty.

New World Medical, manufacturer of several glaucoma devices including the Ahmed Glaucoma Valve, Ahmed ClearPath, Streamline Surgical System, and the Kahook Dual Blade (KDB) submitted the following comments. They recommend that the related Billing and Coding article definition of goniotomy is consistent with the AAO fact sheet definition for goniotomy and their billing and coding guidance.

New World Medical states concerns about an LCD reconsideration letter attached to the LCD.

A definition section has been added to the LCD and the coverage criteria for goniotomy must meet this definition to qualify for coverage.

LCD reconsiderations can be submitted by any stakeholders within the jurisdiction. The policy decisions in an LCD are based on evidence-based review. LCD reconsideration requests are required to be attached to the LCD as part of the LCD documentation and does not indicate support or non-support of the request by the MAC.

A comment was received by Allergan manufacturer of the XEN^® Glaucoma Treatment System, requesting removal of the requirement for progressive damage and IOP ≥ 20 mmHg on maximally tolerated medical therapy for XEN^® to be considered reasonable and necessary. Supporting literature was provided.

The 2 supporting articles included a randomized controlled trial comparing the XEN^® stent to the gold standard trabeculectomy and demonstrating non-inferiority. Baseline IOP's in the study population were as low as 15mmHg. The other report was a systematic review which also included additional reports with baseline IOP <20mmHg. Both studies have been added to the LCD. Based on this additional submitted literature the coverage criteria were modified for progressive damage or IOP ≥ 20 mmHg.

A comment was received from Iridex Corporation regarding transscleral cyclophotocoagulation and provides supporting literature for continuous wave and MicroPulse CPC. They also state it should not be coded as CPT^® 66762 but rather 66710.

See Comment #12. Thank you for bringing this to our attention the related Billing and Coding article has been updated.

One commenter gave a testimonial stating they had a family member that benefited from a MIGS procedure.

We sincerely thank you for sharing your experience with us.

Multiple comments were received expressing opposition to the proposed draft LCD and stating that MIGS procedures are not investigational.

We sincerely thank you for sharing your concerns with us. To justify coverage, the level of evidence we are seeking is summarized in the coverage section of the LCD for transparency.

One commenter recommended multiple changes to the CPT^® coding in the proposed related Billing and Coding article.

We sincerely thank you for your recommendations. These recommendations will be taken into consideration and the Billing and Coding article will be revised accordingly.

Ophthalmologists should be the only deciders on site-saving glaucoma surgeries!

We sincerely thank you for your comment.

One commenter expressed concern about the proposed LCD as it related to the XEN^®45 gel stent. Stating “I routinely use this device in patients who have moderate to severe glaucoma and cataracts who need cataract surgery to reduce their eye drop burden and better control their eye pressure.” References were provided.

We sincerely thank you for your comments and providing additional references. In review of the literature, to justify coverage, the level of evidence we are seeking is summarized in the coverage section of the LCD for transparency.

Since procedure codes 66174 (canaloplasty) and 65820 (goniotomy) are payable procedures in the ASC, how are we to report coding for these procedures when they are performed using any of the devices listed as investigational in the proposed LCD (i.e., iAccess, Omni or Kahook blades)?

Please see Comments/Responses 5 and 6. Palmetto GBA recommends using correct coding convention when submitting claims. Per the instructions for use of the CPT^® codebook, “Select the name of the procedure or service that accurately identifies the service performed. Do not select a CPT code that merely approximates the service provided.”