Comment on CMS-2026-2344-0001

The Honorable Mehmet Oz, Administrator Centers for Medicare & Medicaid Services Attention: CMS-1850-P RE: CMS-1850-P CY 2027 OPPS/ASC Proposed Rule CPT 0621T: request to remove ASC device-intensive designation and apply standard APC 5492 rate-setting Dear Administrator Oz: I write as a retired attorney, Medicare beneficiary, and patient who has personally lost vision after eye surgery. I am concerned that CMS’s proposed CY 2027 ASC payment for CPT 0621T, $4,059, is not supported by the agency’s own record. CPT 0621T is a Category III code for use of the ELIOS System in glaucoma. The proposed rate rises about 11%, while other APC 5492 procedures decline about 3% in Addendum BB. The difference is attributable to CPT 0621T’s device-intensive J8 designation in Addendum BB, the only procedure in the APC so designated. I believe this designation is unjustified and may harm Medicare beneficiaries by nearly doubling facility coinsurance for an investigational, implant-free laser procedure. As a beneficiary, I would have no practical way to know that one glaucoma procedure could nearly double my facility coinsurance compared with similar procedures in the same APC. The ELIOS System does not have FDA marketing authorization. CPT 0621T is payable only through Medicare Category B IDE coverage. The claims used for rate-setting therefore came from sponsor investigational trial sites, not ordinary commercial use, and may not reflect real-world commercial cost. CMS should reconcile this with CPT 0988T in the CY 2026 final rule, where CMS returned the code to status indicator E1 because the device was not yet FDA approved. This is especially important because 0621T’s device-offset record has been unstable. In the January 13, 2025 correction document to the CY 2025 final rule, CMS acknowledged that Addendum P device-offset figures for 0621T were invalid because they came from claims submitted while the code carried status indicator E1. CMS then assigned 0621T a 0% / $0 device offset in the CY 2026 proposed rule, without explanation. In the CY 2026 final rule, CMS designated 0621T device-intensive with a 4.6% offset. The CY 2027 proposed rule now appears to rely on a new implied offset of [ ]%. I do not understand how a 4.6% device offset can satisfy a 30% threshold, and I ask CMS to show the math. I also ask CMS to show how that offset produces a $4,059 ASC payment. If CMS cannot show that calculation, the designation should not stand. CPT 0621T sits in APC 5492 with similar ab interno glaucoma procedures performed through a clear corneal incision and directed at aqueous outflow. Those procedures, including 65820, 66174, 0660T, and X588T, also use single-use instruments. Some leave implants in the eye. Yet they receive standard ASC payment of about $2,136. Under the proposal, CMS would pay about $2,136 to implant a drug-eluting device in the trabecular meshwork, but $4,059 for an implant-free laser procedure directed at the same anatomic target. What resource-cost theory supports that result? The 0621T instrument is not an implanted device. It is a single-use fiber-optic excimer laser probe connected to a capital laser console, a disposable laser-delivery instrument. Medicare already packages comparable intraocular laser probes as surgical supplies. Disposable endolaser probes used with capital laser equipment in pars plana vitrectomy, including CPT 67039 and CPT 67040, do not create device-intensive payment. Nor does the single-use endoscopic laser probe used in CPT 66711. CMS may also compare retinal photocoagulation CPT 67210 and CPT 67228, both delivered from capital laser systems and paid with no device-based premium. If comparable intraocular laser probes in CPT 67039, 67040, and 66711 are packaged supplies, the 0621T probe should be treated the same way unless CMS can show, from actual commercial claims and a calculation the public can follow, why it is materially different. The designation directly raises beneficiary coinsurance. ASC coinsurance is generally 20% of the facility payment. A fee-for-service Medicare beneficiary without supplemental coverage would pay about $385 more per eye, almost 90% more in copay, for 0621T than for similar APC 5492 procedures: about $811 versus $427. That extra coinsurance is not tied to a retained implant, different incision, different anesthesia, or clearly different recovery. It is created by the device-intensive label itself. The payment difference of almost $2,000 per case is also large enough to affect which procedure is chosen and how often it is used, including in ASCs with a direct financial interest in procedure volume. I ask CMS to reconsider the device-intensive designation for CPT 0621T, use the standard APC 5492 ASC rate, and publish the claim counts, facility counts, offsets, and calculations so the public can understand the result. Thank you for your consideration.