LCD Reference Article Response To Comments Article

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

A57735

Expand All | Collapse All
Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

Document Note

Note History

Contractor Information

Article Information

General Information

Source Article ID
N/A
Article ID
A57735
Original ICD-9 Article ID
Not Applicable
Article Title
Response to Comments: Micro-Invasive Glaucoma Surgery (MIGS)
Article Type
Response to Comments
Original Effective Date
12/30/2019
Revision Effective Date
N/A
Revision Ending Date
N/A
Retirement Date
N/A

CPT codes, descriptions, and other data only are copyright 2023 American Medical Association. All Rights Reserved. Applicable FARS/HHSARS apply.

Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Current Dental Terminology © 2023 American Dental Association. All rights reserved.

Copyright © 2024, the American Hospital Association, Chicago, Illinois. Reproduced with permission. No portion of the AHA copyrighted materials contained within this publication may be copied without the express written consent of the AHA. AHA copyrighted materials including the UB‐04 codes and descriptions may not be removed, copied, or utilized within any software, product, service, solution, or derivative work without the written consent of the AHA. If an entity wishes to utilize any AHA materials, please contact the AHA at 312‐893‐6816.

Making copies or utilizing the content of the UB‐04 Manual, including the codes and/or descriptions, for internal purposes, resale and/or to be used in any product or publication; creating any modified or derivative work of the UB‐04 Manual and/or codes and descriptions; and/or making any commercial use of UB‐04 Manual or any portion thereof, including the codes and/or descriptions, is only authorized with an express license from the American Hospital Association. The American Hospital Association (the "AHA") has not reviewed, and is not responsible for, the completeness or accuracy of any information contained in this material, nor was the AHA or any of its affiliates, involved in the preparation of this material, or the analysis of information provided in the material. The views and/or positions presented in the material do not necessarily represent the views of the AHA. CMS and its products and services are not endorsed by the AHA or any of its affiliates.

CMS National Coverage Policy

N/A

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.

N/A

Coding Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

CPT/HCPCS Codes

Please accept the License to see the codes.

N/A

CPT/HCPCS Modifiers

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

ICD-10-PCS Codes

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

Additional ICD-10 Information

Bill Type Codes

Code Description

Please accept the License to see the codes.

N/A

Revenue Codes

Code Description

Please accept the License to see the codes.

N/A

Other Coding Information

Group 1

Group 1 Paragraph

N/A

Group 1 Codes

N/A

N/A

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

Revision History Information

Revision History Date Revision History Number Revision History Explanation
N/A

Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related National Coverage Documents
N/A
SAD Process URL 1
N/A
SAD Process URL 2
N/A
Statutory Requirements URLs
N/A
Rules and Regulations URLs
N/A
CMS Manual Explanations URLs
N/A
Other URLs
N/A
Public Versions
Updated On Effective Dates Status
11/08/2019 12/30/2019 - N/A Currently in Effect You are here

Keywords

N/A