Micro-Invasive Glaucoma Surgery (MIGS) Local Coverage Determination Open Public Meeting - June 03, 2021 - JF Part B

JOCELYN FERNANDEZ:
Good afternoon, or good morning for some of you. Welcome members of the public to the Open Meeting for the proposed LCD, Micro Invasive Glaucoma Surgery or MIGS LCD number DL38299 for Jurisdiction E and DL38301 for Jurisdiction F.

The meeting will be recorded. The audio recording and written transcript will be posted on our website following today's meeting. All lines are currently being muted by our system and will remain muted throughout the meeting. Only registered presenters will be allowed to comment during today's meeting.

For our presenter, you are being allotted 15 minutes to make comments, your line will be opened when it is your turn to speak.

Make sure you are not on mute within your system, or we will not be able to hear your comments. You should be prepared to begin your presentation immediately when called upon and will hear the moderators voice when one minute remains. By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any personal health information during your presentation.

All comments made today should also be submitted in writing. All written comments will be recorded in the response to comments article.

I will now turn the meeting over to Doctor Arthur Lurvey. Dr. Lurvey.

DR. ARTHUR LURVEY:
Thank you, welcome to this Open Meeting.

One thing that distinguishes this open meeting from other open meetings that there already was a policy on MIGS and we are changing it very slightly, which you will hear today, but that change, which opened it up a little bit, were required by CMS.

We have, I believe, only one speaker, possibly a second speaker, and we will let the speaker begin now.

I remind you, one thing that all comments you wish to make should be sent in in writing, so that we can respond to them. All will be responded to.

Finally, before the speaker starts, there were two responses to the draft, both of which suggested changing the language from [inaudible] the IStent having two individual stents to having it up to two stents that was sent by two different commenters.

And now Jocelyn, would you invite the first individual to do the presentation?

JOCELYN FERNANDEZ:
Sure, we have only one presenter today, Mr. Matt Bauer.

Mr. Bauer, your line is open.

MATT BAUER:
Thank you. Can you hear me OK?

JOCELYN FERNANDEZ:
Yes, I can. We can.

MATT BAUER:
Excellent, thank you. My name is Matt Bauer. I'm the Senior Director of Market Access Strategy and Reimbursement for the Glaukos Corporation and on behalf of Glaukos, thank you for the opportunity to present at Noridian's Open Meeting for Micro Invasive Glaucoma Surgery MIGS LCDs 38299 and DL38301.

Next slide, please.

Next slide.

Slide number three.

So, we appreciate the diligence that Noridian has put forward in developing this LCD and I would like the opportunity to review Glaukos's recommendations to develop a clearer policy in order in order to reduce confusion.

First, we concur with Noridian's LCD covering the use of one in two eye stents in the LCD, which is also included in the LCA.

Second, we would like to point out that the LCA recommends using CPT code 0449T for the Hydrus trabecular bypass device, when in fact, per the physician specialty society and the manufacturer's own recommendations that the appropriate code is 0191T not 0449T.

Third, we asked, Noridian to consider including the forthcoming CPT code changes that will go into effect January 1, 2022 in the LCA. If you go to slide four?

Would appreciate the next slide?

RACHEL BOER:
We're having some technical difficulties here.

Just one moment, I do apologize.

MATT BAUER:
OK.

DR. ARTHUR LURVEY:
There is a short period of time when the slides are change automatically and not by the presenter.

So, I apologize for this very slight delay.

MATT BAUER:
I appreciate that.

Then slide number four, next one, I have it. There you go, OK, thank you.

We're requesting that Noridian affirm that 1 and 2 eye stents are reasonable and necessary reflecting the FDA label, and to eliminate the dosing language and the LCD per reference number 27.

Next slide, please.

OK, so, in terms of providing further detail, the appropriate codes, for the use of the Hydrus device is CPT code 0191T, not 0449T as referenced in the LCA. 0449T describes the Zen device and it is anatomically correct per correct coding.

Theres a few things I like to point out, and that's the Hydrous label, which specifies the device is inserted into the Tuberculin Meshwork, not the subconscious conjunctival space, which is described by 0449T.

Secondly, the Physician Specialties Society, in particular, the American Academy of Ophthalmology, has provided guidance that 0191T is the appropriate code for inserting a device into the trabecular meshwork.

And then lastly, per the manufacturer's recommendation, they also recommend utilizing 0191T for thy Hydrus device.

So as a result, we do recommend that Noridian revise the LCD to reflect CPT code 0191T, should be used for the Hydrus trabecular meshwork stent, replacing CPT code 0449T.

Next slide, please.

We also wanted to make Noridian aware that the MIGS procedure codes are changing effective January 1, 2022 per the AMA CPT editorial panel. If panel approve the code changes for MIGS procedures, there will be new codes effective January 1, 2022, then the legacy 0191T, and 0376T are being deleted.

These new code numbers and the descriptors should be released in the August, September timeframe of 2021.

Next slide, please.

This slide depicts the current CPT codes for MIGS procedures, and so the codes are aligned to anatomical location, so this can be used certainly as a guide and this can be used for both CPT code, we included the device code or the device descriptor that the Code describes, and certainly the description.

We did highlight the bolded section or did put that section in bold, again, further as further evidence on the emphasis for anatomical space.

Next slide, please.

This slide summarizes the coding structure for MIGS procedures that are going into effect January 1, 2022. CPT codes are adding three new codes in total, two new category one CPT codes that describe cataracts plus the MIGS procedure and then a new Category three standalone code which does not include cataract extraction.

We do request that Noridian update the LCA to reflect the new coding structure when the codes are released in August, September in line with the implementation of the MIGS LCD.

Next slide.

So, in summary, Glaukos recommends the following,

The following, to, to establish a clear policy and as we do concur that 1 and 2 eye stents are medically necessary per MIGS LCD, based upon correct coding replacing 0449T, 0191T from the Hydrous recommended coding, then we recommend Noridian include the new coding structure in the LCA as it becomes effective.

So, that concludes my presentation, and I thank you for your, your time and attention and I also appreciate the opportunity to present at the Noridian Open Meeting today.

As requested, we will submit written comments to supplement this presentation today.

Thanks for your time.

DR. ARTHUR LURVEY:
May I ask you one question about the proposed change in coding for next year which we have not yet seen, but understand will occur?

That question is, will there be a separate code for the installation of a single eye stent and a separate one for the second, or will the code be one code for either 1 or 2 stents being put in at the same time during a cataract surgery?

MATT BAUER:
Right, thank you for your question. Dr. Lurvey, I understand that the code descriptor will include one or more, so for the two category one CPT codes at a cataract combo, it will be for cataract extraction complex, and standard, and also include language for insertion of aqueous drainage device one or more.

DR. ARTHUR LURVEY:
Thank you.

MATT BAUER:
Yep. And the standalone CPT code will also be, include that same language with one or more.

DR. ARTHUR LURVEY:
Thank you.

MATT BAUER:
Thank you.

JOCELYN FERNANDEZ:
Thank you, Mr. Bauer for your comments.

This concludes today's open meeting.

In closing, we would like to communicate the next steps in the policy development process.

The comment period for the proposed LCD will remain open until July 6, 2021. All comments to be considered by our Medical Directors for the proposed LCD must be submitted in writing. Written comments can be e-mailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCD's are located on our website, at www.noridianmedicare.com.

Upon review of the comments, our Medical Directors will either finalize or retire their proposed LCD.

Please, monitor our web site or register for list serv notifications to be informed of actions taken on our proposed LCDs.

I will now ask Dr. Lurvey for any final remarks, Dr. Lurvey.

DR. ARTHUR LURVEY:
I would just like to thank the people who are listening.

We will respond to all of the written comments, both by Glaukos and also any individual who chooses to make them.

We thank you for listening. We'll let you get back to your busy day, whatever you are doing at this point, and that's all I have to say. Is there anything in close we have on the screen? Where to send all of the proposed comments?

JOCELYN FERNANDEZ:
All right. Thank you. And we appreciate everyone's attendance today, as we know your time is valuable. Enjoy the rest of your day.