And each of these patients would then receive 2mls of amniotic fluid in the epidural space at a symptomatic level using imaging transforaminal. We have to, formulate our policies solely based on the review of the evidence. Revenue Codes are equally subject to this coverage determination. Reproduced with permission. The results were good, statistically significant results in pain reduction and improved function. By clicking below on the button labeled "I accept", you hereby acknowledge that you have read, understood and agreed to all terms and conditions set forth in this agreement. Wise just reviewed. may have one to four pricing codes. It was done by a single physician over 14 months. And so, it's very difficult again because of the heterogeneous nature of the application of the product in the study, not to mention the disparate outcomes that were used in the study again make hard conclusions very, very challenging for this paper. else{document.getElementById("usprov").href="/web/"+"jeb"+"/help/us-government-rights";}, Advance Beneficiary Notice of Noncoverage (ABN), Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS), Medicare Diabetes Prevention Program (MDPP), Diabetic, Diabetes Self-Management Training (DSMT) and Medical Nutrition Therapy (MNT), Fee-for-Time Compensation Arrangements and Reciprocal Billing, Independent Diagnostic Testing Facility (IDTF), Documentation Requests: How, Who and When to Send, Medical Documentation Signature Requirements, Supplemental Medical Review Contractor (SMRC), Unified Program Integrity Contractor (UPIC), Provider Outreach and Education Advisory Group (POE AG), PECOS and the Identity and Access Management System, Provider Enrollment Reconsiderations, CAPs, and Rebuttals, Amniotic Product Injections for Musculoskeletal Indications, Non-Wound Carrier Advisory Committee (CAC) Meeting - May 12, 2021, click here to see all U.S. Government Rights Provisions, American Hospital Association Online Store. However, the big negative for me, is that this was not a randomized control study. 0000008214 00000 n But let's just say it's a thousand or two patients, something like that, and it does appear that there isn't any large safety signal that I saw in the papers that we read. So, in summary of sort of a general overview of this, some preliminary data appears potentially promising. And then lastly, I'll just touch on a trigger finger, tenosynovitis, study. Before you can enter the Noridian Medicare site, please read and accept an agreement to abide by the copyright rules regarding the information you find within this site. procedure code based on generally agreed upon clinically Well said. Wise suggested, that I have the feeling that these therapies may hold promise, but we do not yet have sufficient evidence to recommend their use outside of ongoing research study protocols. And just to emphasize, as MACs, we are required to form our policies, or local coverage determinations based on the evidence. Yes. So, we will now go into our second general discussion which will be conducted by Dr. Barton Wise and he will discuss the general concepts of use. All rights reserved. Users must adhere to CMS Information Security Policies, Standards, and Procedures. Dr. Janet Lawrence [Inaudible] The FDA has now come up with this RMAT approach for allowing some of these products to be used, but that's in the context of licensure, and that's to me, where these products should be going. The [inaudible] one is again, a case series and you'll notice a theme here that almost all of these are uncontrolled studies of a 100 milligrams of injected amniotic chorion membrane. CPT code information is copyright by the AMA. This is Gellhorn, et al, published in 2017. Dr. Will Harvey Any questions pertaining to the license or use of the CDT should be addressed to the ADA. And I also question whether some of these studies really weighed that and did a comparison, an adequate comparison of the traditional methods versus using this as opposed to using this is the first line of treatment. And they did find significant improvements although small, in EQ5D, and KOOS pain for these products in question compared to hyaluronic acid. is based on a calculation using base unit, time So I don't think any of the studies that I reviewed adequately addressed some of those safety concerns. That's basically all I have to share with you right now, and if there are any questions, I'm available. This product includes CPT which is commercial technical data and/or computer data bases and/or commercial computer software and/or commercial computer software documentation, as applicable which were developed exclusively at private expense by the American Medical Association, 515 North State Street, Chicago, Illinois, 60610. So, level one evidence, excellent sample size, with a power analysis of 90%, 73 participants in the study group, 72 in the control group. No, AAMS has clinical practice guidelines for osteoarthritis, and really, even for injections, for osteoarthritis, will shrink the recommendation remains inconclusive. So, with that, I will end, and open to any discussion. Sometimes, a large group can make scrolling thru a document unwieldy. We NEVER sell or give your information to anyone. For any of the literature that you have reviewed, have you seen where these potential complications from the fracturing or other things other then bruising or allergy have been addressed? And this was a randomized, controlled, double blind pilot study. Hello and no I have no conflict of interest. CPT is a trademark of the AMA. We'll just take a moment to allow them to submit their results. iC>:D~c~V*H0"Q%L]5CB Okay, so again, very informative, very helpful and sort of reinforces what we determined from our own literature reviews. Amniotic fluid contains fibrinolytic agents, and there is evidence from %PDF-1.7 % HCPCS code V2790 (amniotic membrane for surgical reconstruction, per procedure) is included in the allowance for CPT Codes 65778 and 65779. One thing I wanted to mention, I'm glad you brought this up, is that, plantar fasciitis or the inflammation maybe the results, for example, of this strain or it could be due to a partial tear. Webcontraindications. They are the same questions. The risk of bias in this trial is moderate, it still was not blinded, and there are some other methodological deficiencies, but this one trial really represents the best evidence that we have for use of these products. They don't have to be completely HLA matched in fact, that's the, the real dangers when they are partially matched, because that, that is such a mismatch. I will point out though, that one of the articles and I don't remember which one actually did have a funnel plot, that is a way to look for publication bias. may perform any of the tests in its subgroups (e.g., 110, 120, etc.). 1441 0 obj <>/Filter/FlateDecode/ID[<2248AA0A91C65F40BB1A5D57E2D75A0E><0C93BBDB7236654683F3A86ED26E47D5>]/Index[1413 49]/Info 1412 0 R/Length 129/Prev 484786/Root 1414 0 R/Size 1462/Type/XRef/W[1 3 1]>>stream Article document IDs begin with the letter "A" (e.g., A12345). Number identifying the reference section of the coverage issues manual. (28 characters or less). Hi. Thank you. A Draft article will eventually be replaced by a Billing and Coding article once the Proposed LCD is released to a final LCD. Billing and Coding articles typically include CPT/HCPCS procedure codes, ICD-10-CM diagnosis codes, as well as Bill Type, Revenue, and CPT/HCPCS Modifier codes. Notch and orientation qe<>O &j'>-3c\BMAi`/@SPPkS u6X \[bkjqkXdV41+ahqg& _p,d4ueQ@Ha s0O There's no real dosing guidance which speaks to the potency of these products, and how, you know, what decision support is provided on appropriate use. For the most part, codes are no longer included in the LCD (policy). These were floral guided intra-articular injections, which is not typically the norm for a study design if you're trying to treat a rotator cuff tear, and the baseline MRI shows, synovitis, capsulitis, effusions, and you're injecting into the joint, to treat the tendon above it particular[inaudible]. hb```b``fe`c`bb@ !( *' F A `ka 34, ^p(1E1;=Es[:$0y2Ma ;/\yn! There were seven common extensor tendon cases, which is the tendon treated for lateral epicondylalgia, or epicondylopathy, or tennis elbow. Should there be some so if someone could just comment on that because I think I saw, throughout all of the papers, they mentioned, I think I got the age of one 81 year old person as the oldest, and in general, I would get, I read about median population ages of say mid 50's give or take with the standard deviation of 10 or 12, or so. And I'll get into some other concerns. There are also conditions treated that vary widely as well ranging from tendinopathies of a variety of types of injuries to osteoarthritis of various joints. Should the foregoing terms and conditions be acceptable to you, please indicate your agreement and acceptance by clicking below on the button labeled "I Accept". Thank you so much for that Dr. Gulur and again, addressing the back pain and facet injections, which is also an area where we're seeing use. These materials contain Current Dental Terminology, (CDT), copyright 2020 American Dental Association (ADA). Sign up to get the latest information about your choice of CMS topics in your inbox. Thank you. All Rights Reserved. Again, we ask the CAC panel members to access the survey condition three questions. And the outcomes used were variable within these studies, as well. so, Dr. Lawrence, we can move on to the next condition. "JavaScript" disabled. There may have been some bias there. Those that may not have been addressed previously or that I felt I wanted to elaborate on. As far as the studies of the whole, before I get into the four studies that I reviewed today, I just wanted to take an overall perspective on this, and, you know, I would also agree with the recognition that's required for publication bias. In article number nine, it showed a decrease in pain with just placebo amniotic products. hbbd```b``kA$ IwD5H9` X^#J=0LIs And I think they hit on the main point, and it seems like we agree. An official website of the United States government. Thank you, Dr. Dr. Janet Lawrence I would, I would agree that there is not adequate for the conditions I reviewed particularly back pain, and cervical facet joint. But it actually looked like there, it looked from that, like there wasn't a lot of publication bias in that particular little subset. There were three conjoined tendon, or proximal hamstring tendon cases, two gluteus medius cases, two patellar tendon, one Achilles tendon. So, amniotic related products were apparently first used in 1909 and have been used since then to support and treat wound, healing, burn treatment, and other indications over the years. It was a variety of tendons. Okay, thank you, panelists, for that discussion in that, and those, that clarification and expansion. Now, interestingly, you know, it's important to note that this methodology, again, not having a control, not come from a comparison group. Are there any other comments from the panelist or from my co-workers? We thank you for all for your time today. Linda, please take it away. Dr. Gajewski, please say hello to our audience and discuss any conflicts of interest you may have at this time. And so that is also something that you are hard pressed to find enough information on. That is definitely partially what I was asking about. Hearing none, we will go back to you, Dr. Ritchie. Which, in looking at these results, there is some, positive support for these products. 3763 0 obj <>/Filter/FlateDecode/ID[<0E4BC2AA5AFA8D4B997D8A10CA1CFDBA><4CD93A296D7E5E4CBC4649794A6D281A>]/Index[3723 76]/Info 3722 0 R/Length 167/Prev 910154/Root 3724 0 R/Size 3799/Type/XRef/W[1 3 1]>>stream Condition three questions should be available. I think FDA is obviously looking at. Next is, I will not attempt to butcher the good Dr. Bhattacharya's name. Please Note: For Durable Medical Equipment (DME) MACs only, CPT/HCPCS codes remain located in LCDs. Get timely coding industry updates, webinar notices, product discounts and special offers. The, there was another study using cortisone. This study itself from both a methodology, product, and, you know, power, stander, standards that are used, as well as instruments for measuring outcomes left a lot to be desired or, you know, definitely would not lead to robust conclusions that people could draw. So, I'm going to touch on just the numbers which are seven for the common extensor tendons and three for the supraspinatus. I completely and absolutely agree. As I mentioned, the lack of ultrasound guidance and all, but one. And there was no change in the rotator cuff anatomy. Which is, where the treatment for back pain, and cervical facet joint will be done is a, particularly, a wonderful site, the fungal meningitis, you know, issues that we we saw with even the steroids that weren't not appropriately stored et cetera and the honestly devastating consequences of infection in the neuraxis should warrant more stringent understanding and process as far as storage and use of these these products. Some of the Provider information contained on the Noridian Medicare web site is copyrighted by the American Medical Association, the American Dental Association, and/or the American Hospital Association. Dr. Barton Wise You have different forces, for instance, the peroneal tendon a [inaudible] function going around the [inaudible]. Thanks Dr. Lawrence. It, you know, looking at it. Are there any questions or comments for Dr. Patients were randomized to receive one injection of Amniofix (n=73) or sodium chloride placebo (n=72). Please click here to see all U.S. Government Rights Provisions. Note: The information obtained from this Noridian website application is as current as possible. of the Medicare program. It was randomized, but it's unclear if it was truly blinded. However, the presence of adequate data to come to a conclusion on use for standard care seems to be lacking. Please contact the Medicare Administrative Contractor (MAC) who owns the document. That it was intra-articular injections, but to be honest, many, probably, most rotator cuff injuries, particularly partial thickness tears, are on the bursal side. But we'll just watch it. And so that's something to think about that I've thought about when I was looking at these. With that being said, we will get right into the formal CAC by beginning with our first speaker, Dr. Gajewski, who will discuss the FDA labeling and general safety, of these products. But I would conclude that I do believe it is safe in the short term. Who was the last speaker, I'm sorry? So very small population size. You agree to take all necessary steps to ensure that your employees and agents abide by the terms of this agreement. Although, in the end, they indicated that the amniotic product was superior. And then these studies, they're so low powered, the cohorts aren't really segregated sufficiently to establish who they work for. CDT is a trademark of the ADA. 2. Enter the code you're looking for in the "Enter keyword, code, or document ID" box. There were no adverse events, which we discussed as well. This is Dr. Ritchie. damages arising out of the use of such information, product, or process. This instruction is effective for dates of service on or after September 4, 2012. And this, the note that the particulate used in the study has been commercially available since 2013, in the United States, as a 361 human cell and tissue-based product. And it compared triamcinolone to 10cc's of freshly collected amniotic fluid. Again, the first two questions are related to safety and the topic this time is Rotator Cuff Patellar, Lateral Epicondylitis, Carpel Tunnel, and Trigger Finger. I have not used them in conjunction with, with microfracture. Thank you, Dr. Harvey. It's a pilot study, with just 10 patients, with, with promising early results, but still lacks not only the power, but the standardization, the selection of cohorts, you know, many of the, the problems that have been brought up already, so, I don't have a lot to add except to echo that, that, we do need more data, that, there are still questions, all these studies say, there's safety and efficacy, but again, they're short-term, and there's still questions, as brought up at the very general section, on safety. Self-Administered Drug (SAD) Exclusion List articles list the CPT/HCPCS codes that are excluded from coverage under this category. Yes. Dr. Janet Lawrence There are times in which the various content contributor primary resources are not synchronized or updated on the same time interval. Avalon Global Care is developing stem cell therapeutics for cancer, but they are, their whole product focus is on China, they have no products, currently or plan for the US marketplace. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. hb```S@(q I J/Q>T0LS'A=N5*}`=$sFN n\l^6lv\(kg(^F-op1?'t&}~CG~ R.w\k$ , Hw4p0ft40t00 l )FPP- developing unique pricing amounts under part B. 0000013585 00000 n WebCPT code 15002/15005 are only appropriately used in place of service inpatient hospital, outpatient hospital or ambulatory surgical center with regional or general anesthesia to resurface an area damaged by burns, traumatic injury or surgery. Thank you. When some of the things such as you mention homologous use and you mentioned the cellular versus acellular type composition, I think, where folks get confused relate to how you apply the FDA concepts of healthy human cells and tissue products, and how do you apply that concept to something that's injected into joints and tendons. Looks like some who were having problems appear to be able to answer these questions, that's good to see. I think you need to have guidance, and this was the only study, as far as I could see, that utilized it. They also used an outcome, called OARSI-OMERACT Responders Group which is another very well standardized outcome, and there were more such responders, meaning people who achieved a better outcome in the Amnion Group, compared to the other groups. So, one of the themes that we're all recognizing is the paucity of high level of research. And, I have used these products intra-operatively on several occasions, both on tendons, and in the knee and the shoulder, and, have anecdotal, you know responses to that, but do not have good trials, long term series, long term follow ups. I will go through and read the questions for this first series. HWAnl))1p9CK,q@:(#"ET.OSnt$v\^lt6btT 9A'w>$bg71w= Y)s.girVu^T_N'%u7Ag>f|vsQ lCN}uCjdgIKLYvO0>E,bRpUuCXX_"RkdEN""/@1] $' O*o5-OEJmq@Hc^VVl 0 So, we're going to proceed on to Dr. Block. And, looks like, we have seven so if were having some technical issues, it does appear we are, we have everyone. 0000008200 00000 n But I completely agree that I would highly suspect that overall, in this area, there is publication bias, in other words, negative studies not being published. It's unclear if the products are stating that they're active materials, growth factors or stem cells, per se. The product, itself, 50 milligrams of particulate and you see, it was a single center case series. And as another speaker has very well pointed out, no real growth factor analysis. Any other comments regarding their use in our population? That also became a frequent discussion at CPT and RUC that we in internal medicine were held to a higher standard because our literature demands it. For U.S. Government and other information systems, information accessed through the computer system is confidential and for authorized users only. With CMS, they don't fund the data management, the data collection. See our privacy policy. He is a fellow of the American Academy of Orthopedic Surgery, and he is affiliated with Presbyterian Hospital in Albuquerque, New Mexico. Moving on to our general housekeeping item. Hi, good afternoon. For further information regarding the LCD process in general, or the CAC process specifically, please look to Medicare Program Integrity Manual, Chapter 13, or the CAC section, look to Chapter 13.2.4.3. And, as one of our, speakers has just pointed out, again, the actual products being used, and, you know, from both the safety and efficacy, and, honestly, content perspective, seem to leave a lot to be desired in terms of further investigation and standardization. But there was no data for long term relief past two months. And since some of these studies had multiple tendinopathy conditions, some of them may crossover versus being discussed individually. So, in terms of looking at harm and adverse events associated with a single injection, just based on these studies, there were no major adverse events that were reported in any of these studies. You know, I'm not sure it's appropriate if, as we've discussed several times now, to kind of lump all these things together. Dr. Janet Lawrence It's not necessarily without confounding variables. Okay, we'll make note, and as we indicated, because we know technologies and where our individuals are at, we will obtain your results most definitely, if not today, or after the meeting. The last one, the Farr study, is the best of the group. And I think that that's imperative. Review the article, in particular the Coding Information section. Dr. Will Harvey I have a question. 0000016676 00000 n But, given what I stated, not homologous use of cells or allogeneic cells are subject to licensure. Receive Medicare's "Latest Updates" each week. Dr. Janet Lawrence He completed a foot and ankle fellowship at the Andrews Research Institute in Pensacola, Florida, he is a member of the American Orthopedic Foot and Ankle Society, a member of the American Academy of Family Physicians and the South Carolina Orthopedic Association. So, one has to question whether the efficacy of the product is in repairing the plantar fascia in fact, as a tear? And I know Janet advised against anecdotal issues, but I was at UCLA in the early years of the Gann Act where we were required to ask patients if they wanted to have designated blood donors. $-gdE`Z\a\8 4p.iR,U}Lg":D7g2D I2OFds ` 1jK2qiYm4{400TI &. 30% was the MCID that they use which was pretty generous and then they had a secondary functional outcome measure using the patient specific functional scale. The scope of this license is determined by the AMA, the copyright holder. The scope of this license is determined by the AMA, the copyright holder. 0000006208 00000 n But again, this is a conclusion just based on a small cohort. The CAC process supplements the Medicare Administrative Contractors, internal expertise and is to help to ensure an unbiased and contemporary consideration of newly developed technology and science. They will be introduced in alphabetical order, not speaking order.

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