Local Coverage Article Response to Comments

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


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

As an important part of Medicare Local Coverage Determination (LCD) development, National Government Services solicits comments from the provider community and from members of the public who may be affected by or interested in our LCDs. The purpose of the advice and comment process is to gain the expertise and experience of those commenting.

We would like to thank those who suggested changes to the Micro-Invasive Glaucoma Surgery (MIGS) LCD. The official notice period for the final LCD begins on October 10, 2019, and the final determination will become effective on December 1, 2019.


Response To Comments


The manufacturer of iStent inject and two practicing ophalmologists submitted comments endorsing the proposed coverage criteria of iStent inject. However, their main focus was directed at presenting data intended to support extra payment for multiple stents, specifically the second stent intrinsic to the iStent inject device. They requested that iStent inject be billed with “CPT codes 0191T and 0376T,” and that “code 0376T be moved from Group 2 to Group 1 in the related Coding Article A56588, Billing and Coding for Micro-Invasive Glaucoma Surgery.”

NGS disagrees. First, due to changes related to the 21st Century Cures Act, billing and coding information is no longer part of the LCD, and therefore no longer subject to official comment on the LCD. Second, the proposed draft considers coverage of “one device per eye medically reasonable and necessary for the treatment of adults with mild or moderate open-angle glaucoma and a cataract when the individual is currently being treated with an ocular hypotensive medication and the procedure is being performed in conjunction with cataract surgery.” No change was made to non-coverage of more than one device; therefore, that component of the LCD is not open to comment. A request to expand coverage to include multiple devices can be made via a reconsideration request. However, it is doubtful that such expansion would apply to iStent inject, as the device is a 2-stent system, and therefore, is adequately described by 0191T alone (insertion initial device). The 2-stent device was studied, FDA approved, and now covered by this LCD; there is no coverage for placement of part of the device (i.e., only one of the two stents). If the company feels iStent inject deserves distinct coding from the original iStent device, they can request a unique code, preferably a Category I code, rather than permanently rely on T (temporary) codes.

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