LCD Reference Article Response To Comments Article

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

A57740

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
First Coast Service Options, Inc.	A and B MAC	09101 - MAC A	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09102 - MAC B	J - N	Florida
First Coast Service Options, Inc.	A and B MAC	09201 - MAC A	J - N	Puerto Rico Virgin Islands
First Coast Service Options, Inc.	A and B MAC	09202 - MAC B	J - N	Puerto Rico
First Coast Service Options, Inc.	A and B MAC	09302 - MAC B	J - N	Virgin Islands

Article Information

General Information

Article ID
A57740

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

Article Type
Response to Comments

Original Effective Date
12/30/2019

Retirement Date
N/A

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Article Guidance

Article Text

First Coast Service Options, Inc. (First Coast) received comments from the American Society of Cataract and Refractive Surgery (ASCRS) and numerous comments from interested parties from within and outside the Medicare Administrative Contractor (MAC) Jurisdiction N (JN) for Florida, Puerto Rico and the United States Virgin Islands, for the Proposed Local Coverage Determination (LCD) DL38233/A56647 Micro-Invasive Glaucoma Surgery (MIGS). All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number	Comment	Response
1	Multiple comments were received describing the technical procedure for placement of eye stents and stating the second device requires similar work and time. Repositioning of the applicator, maintaining a prism on the eye surface to visualize the narrow, delicate trabecular meshwork, locating the optimal site for implantation in order to access the collector channels, inserting the trocar with just enough force to implant the device, keeping a steady, relaxed hand and deploying the delivery button to implant the stent, and finally withdrawing the applicator leaving the Stent in ideal position. All these maneuvers require exquisite fine motor skills, excellent stereopsis, and the clinical expertise to know how, when, and to whom to use the device in. These devices are life altering for patients who receive them. They are often able to reduce or eliminate daily eye drops for their glaucoma. Implanting two stents loaded in the iStent inject® is equivalent to performing two separate device insertions. The skilled surgeons taking care of these patients should be reimbursed appropriately for their time and surgical expertise to place the second iStent the work is not “negligible”. Therefore, both CPT® code 0191T and 0376T should be covered services.	First Coast appreciates your comments; First Coast’s LCD provides limited coverage for the placement of 2 iStents utilizing the iStent inject®; considered medically necessary since it appears to allow for an increased reduction in IOP and medication reduction to that achieved by using a single iStent device and appears to achieve similar reduction in IOP and medication reduction to other available procedures. Although more than one drainage device into the trabecular meshwork of a single eye on a single day of service, using an insertion tool loaded with more than one device, (e.g., iStent inject®) may be performed, once the insertion tool is deployed within the eye, the work and clinical skill required to place additional device (s) is equivalent to placement of other FDA cleared devices described by the same code. Therefore only one unit of 0191T per eye per day may be billed, regardless of the number of devices inserted into a single eye on the same date of service. After consideration, First Coast revised the statement “…there is negligible increase in work or expense.” In the “Utilization” section of A56647 to read, “…the work and clinical skill required to place additional device (s) is equivalent to placement of other FDA cleared devices described by the same code as well as achieving similar therapeutic outcomes to other devices coded as 0191T.”
2	Multiple comments were submitted with the following comment: under Covered Indications, the second paragraph defines uncontrolled intraocular pressure (IOP) as “progressive damage and mean diurnal medicated IOP greater than or equal to 20 mm Hg.” There is a significant subset of patients that develop progressive glaucomatous damage despite IOPs remaining below 20 mm Hg that would benefit from MIGS. The Academy requests that the LCD define uncontrolled IOP as “progressive damage and/or mean diurnal medicated IOP greater than or equal to 20 mm Hg.”	First Coast appreciates the comments, after consideration, First Coast has revised the Covered Indications definition of uncontrolled IOP as “progressive damage and/or mean diurnal medicated IOP greater than or equal to 20 mm Hg”.
3	Multiple comments were submitted with the following: under Provider Qualifications, the provider has concerns with the wording of the continuing medical education (CME) requirements. While the provider agrees that surgeons that perform MIGS must have adequate training to be proficient, the LCD disqualifies valuable non-CME educational avenues and includes a non-specific reference to “extensive” CME. Surgeons learn at different paces and learn best with different modalities. Disqualifying an entire category of educational material runs the risk of degrading rather than enhancing the educational experience. It is not possible to define an adequate post-residency/fellowship training program within the scope of an LCD. It is best left to hospitals, ambulatory surgery centers to determine qualifications for specific surgical privileges, and to the organizations that accredit them and office surgical suites to determine whether their privilege-granting processes are adequate.	First Coast appreciates the comments, the Insertion of glaucoma drainage devices addressed in this LCD must be performed by a qualified physician (MD or DO) who is a board certified ophthalmologist having completed a residency and/or fellowship program and maintains ongoing certification in ophthalmology.
4	American Society of Cataract and Refractive Surgery (ASCRS) commented that currently First Coast is paying for the additional work required to place the second stent (0376T). The justification for the payment reversal is not clear.	First Coast appreciates your comment. Please see response to comment #1.
5	A number of commenters disagree with the statement “there is negligible increase in work or expense” per the Billing and Coding Article (A56647).	First Coast appreciates your comment. Please see Contractor response to comment #1.
6	In terms of professional fee payment, we understand that CPT® code 0191T is carrier-priced based upon the time, work, and intensity to implant the initial stent. These same fee setting principles should apply to CPT® code 0376T (…each additional device insertion) as an add-on code to CPT® code 0191T (…initial insertion) when determining professional fee reimbursement for the second code (0376T). We support a fair and equitable payment amount for pricing CPT® code 0376T consistent with the additional time, intensity and work required to implant the second stent.	First Coast appreciates your comment. Please see Contractor response to Comment #1.
7	For payment purposes, in the surgical facility, CPT® code 0376T is packaged in the facility setting. As such, we understand and agree that there is no additional facility payment associated with the placement of a second stent. This packaging however, should not apply to the professional fee and that the current First Coast physician fee schedule value for CPT® 0376T remain in place.	First Coast appreciates your comment. Please see Contractor response to Comment #1.

Coding Information

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1 Codes

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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ICD-10-PCS Codes

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion

Revision History Information

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Associated Documents

Related Local Coverage Documents
Articles
A56647 - Billing and Coding: Micro-Invasive Glaucoma Surgery (MIGS)

Updated On	Effective Dates	Status
11/08/2019	12/30/2019 - N/A	Currently in Effect	You are here

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

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