LCD Reference Article Response To Comments Article

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

A57735

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Novitas Solutions, Inc.	A and B MAC	04111 - MAC A	J - H	Colorado
Novitas Solutions, Inc.	A and B MAC	04112 - MAC B	J - H	Colorado
Novitas Solutions, Inc.	A and B MAC	04211 - MAC A	J - H	New Mexico
Novitas Solutions, Inc.	A and B MAC	04212 - MAC B	J - H	New Mexico
Novitas Solutions, Inc.	A and B MAC	04311 - MAC A	J - H	Oklahoma
Novitas Solutions, Inc.	A and B MAC	04312 - MAC B	J - H	Oklahoma
Novitas Solutions, Inc.	A and B MAC	04411 - MAC A	J - H	Texas
Novitas Solutions, Inc.	A and B MAC	04412 - MAC B	J - H	Texas
Novitas Solutions, Inc.	A and B MAC	04911 - MAC A	J - H	Colorado New Mexico Oklahoma Texas
Novitas Solutions, Inc.	A and B MAC	07101 - MAC A	J - H	Arkansas
Novitas Solutions, Inc.	A and B MAC	07102 - MAC B	J - H	Arkansas
Novitas Solutions, Inc.	A and B MAC	07201 - MAC A	J - H	Louisiana
Novitas Solutions, Inc.	A and B MAC	07202 - MAC B	J - H	Louisiana
Novitas Solutions, Inc.	A and B MAC	07301 - MAC A	J - H	Mississippi
Novitas Solutions, Inc.	A and B MAC	07302 - MAC B	J - H	Mississippi
Novitas Solutions, Inc.	A and B MAC	12101 - MAC A	J - L	Delaware
Novitas Solutions, Inc.	A and B MAC	12102 - MAC B	J - L	Delaware
Novitas Solutions, Inc.	A and B MAC	12201 - MAC A	J - L	District of Columbia
Novitas Solutions, Inc.	A and B MAC	12202 - MAC B	J - L	District of Columbia
Novitas Solutions, Inc.	A and B MAC	12301 - MAC A	J - L	Maryland
Novitas Solutions, Inc.	A and B MAC	12302 - MAC B	J - L	Maryland
Novitas Solutions, Inc.	A and B MAC	12401 - MAC A	J - L	New Jersey
Novitas Solutions, Inc.	A and B MAC	12402 - MAC B	J - L	New Jersey
Novitas Solutions, Inc.	A and B MAC	12501 - MAC A	J - L	Pennsylvania
Novitas Solutions, Inc.	A and B MAC	12502 - MAC B	J - L	Pennsylvania
Novitas Solutions, Inc.	A and B MAC	12901 - MAC A	J - L	Delaware District of Columbia Maryland New Jersey Pennsylvania

Article Information

General Information

Article ID
A57735

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

The following are the comment summaries and contractor responses for Novitas Solutions Proposed Local Coverage Determination (LCD) DL38223, Micro-Invasive Glaucoma Surgery (MIGS) which was posted for comment on June 27, 2019, and presented at the July 2019 Contractor Advisory Committee (CAC) Meeting. 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. In addition, the American Society of Cataract and Refractive Surgery (ASCRS) commented that currently the additional work required to place the second stent (0376T) is being compensated for. The justification for the payment reversal is not clear. 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. Additionally, 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 physician fee schedule value for CPT^® 0376T should remain in place. 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.	We appreciate your comments. The 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 as well as allowing therapeutic outcome to more closely approximate that of other devices coded as 0191T. 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, we revised the statement “…there is negligible increase in work or expense.” In the “Frequency Limitations” section of A56633 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”.
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 mmHg.” There is a significant subset of patients that develop progressive glaucomatous damage despite IOPs remaining below 20 mmHg 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 mmHg.”	We appreciate the comments, after consideration, we have revised the Covered Indications definition of uncontrolled IOP as “progressive damage and/or mean diurnal medicated IOP greater than or equal to 20 mmHg”.
3	Multiple comments were submitted with the following: under Provider Qualifications, the commenter has concerns with the wording of the continuing medical education (CME) requirements. While the commenter 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 and to organizations that accredit them to determine qualifications for specific surgical privileges. Office surgical suites should be able to determine whether their privilege-granting processes are adequate.	We appreciate 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.

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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N/A

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

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N/A

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Bill Type 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

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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