Platelet Rich Plasma Injections for Non-Wound Injections Open Public Meeting - July 21, 2021 - JE Part A

Jocelyn Fernandez:
Good afternoon, or good morning depending on where you are joining us from. Welcome members of the public to the Open Meeting for the proposed Local Coverage Determination (LCD), Platelet Rich plasma Injections for Non-Wound Injections, LCD number DL39058 for Jurisdiction E and DL39060 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 10 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 you. 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 Dr. Eileen Moynihan.

Dr. Eileen Moynihan:
Hello, everybody. Welcome to the Open Meeting on Platelet Rich Plasma. I want to thank you ahead of time for the time that you're allotting to give us comments with regard to the draft policy.

This meeting is for the Contractor Medical Directors to take your comments, but it is not a question-and-answer period at this point in time. All comments subsequently should be in writing and submitted to the appropriate website which we will go over, and I think at this point we can move on to the first commenter. Jocelyn.

Jocelyn Fernandez:
Okay. The first commenter is Ms. Tiffany Facile.

Ms. Facile, you may begin your presentation.

Ms. Tiffany Facile:
Hi, thank you, hoping you can hear me. My name is Tiffany Facile and I am the Clinical Director of Regenerative Medicine at Sanford Health. We are a non-profit health care system located predominantly in the Mid-West, North and South Dakota. Platelet Rich Plasma is something that has been utilized here at Sanford for an extended period of time in orthopedics and outside of orthopedics.

I'm commenting today as a potential solution and proposal to, to you all as an opportunity to get these therapies approved for our patients. So, I read the comments and all of the studies that were outlined with their associate indications. I cannot disagree with you more. I, too, am frustrated with the magnitude of research studies that are out there, many of which are poor quality, but, certainly, furthermore, I, the research studies are addressing, I believe, medical conditions that are not appropriate to initiate with Platelet Rich Plasma.

Furthermore, I have extensive history from a bench and clinical research experience standpoint, to identify the optimal solution for platelet counts and so forth to really provide the efficacy that that, I believe you are looking for. And so, with that said, you know, would it be an opportunity to create a clinical registry, much like a TAVR registry that we've participated in the past and do what you have suggested to standardize the, the injection volume, the injection frequency, isolate to one system. Again, not to play favorites, but I do believe that there is extreme data out there that 's just not published, that if we could identify a targeted indication, let's say, knee osteoarthritis, grade three, and platelet counts, and, you know, 8 to 10 billion beyond the baseline leukocyte poor with no RBC, is I do think a single injection at 12 months would show favor to patient outcomes.

So, with that said, if, if, it's my proposal, is that we create a clinical registry, standardize this information, collect patient reported outcomes, in addition to identifying one targeted disease population, and provide that data to you to outline its efficacy. I, I am a strong believer in identifying this as a safe and effective option for our patients, However, we have to do it right, as a health community. And I do believe that creating a clinical registry with the necessary standard information will lead to potential solutions for our patients and certainly our payers.

Dr. Eileen Moynihan:
Thank you. Just make sure your comments are in writing. I am not in a position to agree or disagree with a registry at this point in time, usually something like that would be setup by CMS or individuals, specialty societies, to look at those issues in combination with CMS, not really in the purview of the contractor to do that. There's a lot of, there are a lot of issues with sharing of information that come up in those circumstances. Kind of make it almost impossible for us as contractors to do but your comments can certainly come in and we can pass that on to CMS or you can directly pass that on to CMS. But thank you for your comments.

Ms. Tiffany Facile:
Thank you.

Jocelyn Fernandez:
OK, the second commentor is Dr. Boris Ratiner and we just learned that he will not be presenting today so we can move on to the last commentor.

That last commentor is Mr. Antony Robert.

Mr. Robert, you may begin your presentation.

Mr. Robert, you might be on mute. Can you unmute your line, or your device?

Dr. Eileen Moynihan:
It maybe that, he thought perhaps he was going to come on a bit later in view of the second speaker was unable to speak. Perhaps we should give him a few minutes unless you can tell whether he's got a mic problem or not.

Jocelyn Fernandez:
OK, give us a few seconds here.

I see that he, he called in again.

Hold on.

Mr. Robert, if you can hear me, it looks like, on our end that you are self-muted. Can you please unmute yourself from your device?

Mr. Antony Robert:
Yes, I can hear you, can you hear me now?

Jocelyn Fernandez:
OK, great. Yes, I can hear you.

You may begin your presentation.

Mr. Robert, you may begin your presentation.

Mr. Antony Robert:
Oh, my presentation?

Jocelyn Fernandez:
Yes, are you planning to present any comments today?

Mr. Antony Robert:
No, I did not.

Jocelyn Fernandez:
Oh, OK, we, we saw that you registered as a presenter, but that's not a problem. We can just move on to the closing and next steps.

So, this concludes the presentations for today's 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 August 7, 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. Moynihan for any final remarks.

Dr. Eileen Moynihan:
Again, just want to thank all of you who took the time to participate in today's meeting, and please be sure you get your written comments in if you have comments to make based on the draft, and, of course, we are always happy to receive any new literature that you have not or in the future and watch out website for the final draft. Thanks.

Jocelyn Fernandez:
Thank you everyone for attending. This concludes our meeting for today. Enjoy the rest of your day.