Glaucoma patients and their surgeons were recently attacked when several Medicare Administrative Contractors (MACs) released a draft proposal for procedure coverage that is seriously misguided. The proposal, issued by use of a local coverage determination (LCD), is attempting to categorize goniotomy, canaloplasty, and cyclophotocoagulation as experimental. The first draft LCD, designated DL39620, is highly problematic for several reasons. The most striking feature of the proposal is how many typos and spelling errors were present throughout the document. For example, many of the names of procedures this LCD called “experimental” were misspelled. “Cytophotocoagulation” and “Trabectone” were listed, but not cyclophotocoagulation and Trabectome (MicroSurgical Technology).

If an entity is willing to let glaucoma patients go blind by proposing to remove vision-saving therapies from the glaucoma surgeon’s arsenal, it should at least spell the procedure names correctly. The errors in the LCD document, which, of course, have been cut and pasted into subsequent LCDs for other MACs, demonstrate the crass and careless way these MACs decided to propose disposing of popular glaucoma procedures. These mistakes imply that the level of research that went into determining which options lacked supporting data was insufficient — and indeed that was the case.

Why are goniotomy, canaloplasty, and cyclophotocoagulation under attack? It is likely the popularity and growth of these procedures that made them targets for possible cuts. Here 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.

The most glaring example of this applies to goniotomy. Medicare claimed that although pediatric goniotomy had excellent clinical data support, adult goniotomy did not. While I believe both procedures have sufficient supporting clinical data, adult goniotomy has stronger literature support behind it, with more than 90 peer-reviewed publications supporting safety and efficacy across a wide range of adult glaucoma. This includes a multicenter prospective randomized controlled trial in which goniotomy and cataract extraction in mild and moderate primary open-angle glaucoma compared favorably to cataract extraction with the iStent (Glaukos).¹ This is level-one supporting evidence. To me 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.

It also is simply bizarre that cyclophotocoagulation was called experimental by the LCDs. This versatile procedure has been around since the 1980s and is the subject of many clinical investigations. In fact, I myself have published 14 articles on goniotomy, canaloplasty, and cyclophotocoagulation that the Medicare LCD ignored.^2-14 I conclude that if the LCD documents made any type of case, the single argument made was that the Medicare MAC administrators are uninformed.

Imagine a world where glaucoma specialists cannot pick the best option for surgical intervention for each individual patient. Physicians have fought so hard to innovate new ways to treat patients more safely. Companies have spent many millions of dollars innovating minimally invasive techniques to help stave off filtration surgery. We have come so far in the past 2 decades, and progress is now in jeopardy.

What can we, as physicians fighting the good fight against glaucoma, do about this proposal? We all must stand strong against this lunacy on behalf of our patients. Look to emails from your national societies, AAO, AGS, or ASCRS, on these topics. Actively participate by writing letters and encouraging friends and colleagues to do the same. Ask your patients to write their representatives to explain what the impact would be on their health and independence. If you are friends with any influential politicians, let your society know. Now is a good time to ask them for help and make sure our message is being carried through the halls of congress.

If these proposals go into effect, we will have a multitier system where those who can afford to travel to regions that allow for procedure coverage or are able to pay out of pocket are better able to access needed care. Those without means to travel or pay out of pocket for care will be left without the choices available to others. Patients with private insurances, often younger individuals, will have access to more choices compared to Medicare-aged patients. This ill-conceived and poorly informed proposal encourages systemic and systematic inequality, plain and simple. Thank you for protecting glaucoma patients. GP

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

References

1. Falkenberry S, Singh IP, Crane CJ, et al. Excisional goniotomy vs trabecular microbypass stent implantation: a prospective randomized clinical trial in eyes with mild to moderate open-angle glaucoma. J Cataract Refract Surg. 2020;46(8):1165-1171. doi:10.1097/j.jcrs.0000000000000229
2. SooHoo JR, Seibold LK, Radcliffe NM, Kahook MY. Minimally invasive glaucoma surgery: current implants and future innovations. Can J Ophthalmol. 2014;49(6):528-533. doi:10.1016/j.jcjo.2014.09.002
3. Dorairaj S, Radcliffe NM, Grover DS, Brubaker JW, Williamson BK. A review of excisional goniotomy performed with the Kahook Dual Blade for glaucoma management. J Curr Glaucoma Pract. 2022;16(1):59-64. doi:10.5005/jp-journals-10078-1352
4. Tan NE, Chen SX, Fang AH, Radcliffe NM. Outcomes of sutureless Ahmed glaucoma valve surgery: a retrospective study. Ophthalmol Ther. 2022;11(6):2083-2100. doi:10.1007/s40123-022-00565-0
5. Radcliffe N. The case for standalone micro-invasive glaucoma surgery: rethinking the role of surgery in the glaucoma treatment paradigm. Curr Opin Ophthalmol. 2023;34(2):138-145. doi:10.1097/ICU.0000000000000927
6. Panarelli JF, Vera V, Sheybani A, et al. Intraocular pressure and medication changes associated with Xen gel stent: a systematic review of the literature. Clin Ophthalmol. 2023;17:25-46. Published 2023 Jan 5. doi:10.2147/OPTH.S390955
7. Greenwood MD, Seibold LK, Radcliffe NM, et al. Goniotomy with a single-use dual blade: short-term results. J Cataract Refract Surg. 2017;43(9):1197-1201. doi:10.1016/j.jcrs.2017.06.046
8. Tracer N, Ayoub S, Radcliffe NM. The association between corneal hysteresis and surgical outcomes from trabecular meshwork microinvasive glaucoma surgery. Graefes Arch Clin Exp Ophthalmol. 2021;259(2):475-481. doi:10.1007/s00417-020-04921-3
9. Tracer N, Dickerson JE Jr, Radcliffe NM. Circumferential viscodilation ab interno combined with phacoemulsification for treatment of open-angle glaucoma: 12-month outcomes. Clin Ophthalmol. 2020;14:1357-1364. doi:10.2147/OPTH.S252965
10. Grippo TM, de Crom RMPC, Giovingo M, et al. Evidence-based consensus guidelines series for micropulse transscleral laser therapy: dosimetry and patient selection. Clin Ophthalmol. 2022;16:1837-1846. doi:10.2147/OPTH.S365647
11. Sarrafpour S, Saleh D, Ayoub S, Radcliffe NM. Micropulse transscleral cyclophotocoagulation: a look at long-term effectiveness and outcomes. Ophthalmol Glaucoma. 2019;2(3):167-171. doi:10.1016/j.ogla.2019.02.002
12. Tan NE, Tracer N, Terraciano A, Parikh HA, Panarelli JF, Radcliffe NM. Comparison of safety and efficacy between ab interno and ab externo approaches to Xen gel stent placement. Clin Ophthalmol. 2021;15:299-305. doi:10.2147/OPTH.S292007
13. Dorairaj SK, Seibold LK, Radcliffe NM, et al. 12-month outcomes of goniotomy performed using the Kahook Dual Blade combined with cataract surgery in eyes with medically treated glaucoma. Adv Ther. 2018;35(9):1460-1469. doi:10.1007/s12325-018-0755-4
14. Rathi S, Radcliffe NM. Combined endocyclophotocoagulation and phacoemulsification in the management of moderate glaucoma. Surv Ophthalmol. 2017;62(5):712-715. doi:10.1016/j.survophthal.2017.01.011