National Coverage Analysis (NCA) View Public Comments

Autologous Blood-Derived Products for Chronic Non-Healing Wounds

Public Comments

Commenter Comment Information
ABREBAYA, ALBERTO Title: FOOT & ANKLE SURGEON CERTIFIED WOUND SPECIALIST
Organization: Podiatry Surgical Associates INC.
Date: 01/18/2021
Comment:

DFUs and VLUs dominate the spectrum of chronic wounds. Considering the risks for infection, gangrene, amputation and life-altering complications for a patient ailing with a chronic open wound, it is of paramount importance that implementation of products with proven efficacy to the long-term successful treatment of these ulcers be undertaken.

A medical device that prepares an autologous combined leucocyte, platelet and fibrin patch* from autologous blood by an automated 20-min

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BenAvram, Debra Title: Chief Executive Officer
Organization: AABB
Date: 01/20/2021
Comment:

January 20, 2021

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

Re: Proposed Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R4)

Dear Ms. Jensen:

AABB appreciates the opportunity to submit comments in response to the Proposed

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Fife, Caroline Title: MD
Organization: Medical Director CHI SLEH Wound Clinic, the Woodlands, TX
Date: 01/20/2021
Comment:

I have been in the full-time practice of wound management for 30 years and am a nationally recognized expert in the field. I have extensive clinical experience with several different autologous PRP formulations both inside and outside of IRB approved clinical trials. I applaud CMS’ determination in the Proposed Decision Memo, to both authorize coverage of autologous PRP for the treatment of chronic non-healing diabetic foot ulcers (DFUs) and allow local MACs to decide whether to cover the

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gude, warren Title: md
Date: 01/20/2021
Comment:

During the public comment period earlier this year upon the posting of the initial tracking sheet, I submitted a comment in my capacity as the lead author on the paper published in the September 2019 issue of Advances in Skin and Wound Care entitled "Aurix Gel Is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial". [Then, as now, I have no financial disclosures.] I commented at that time that subjects enrolled at St. Luke's Wound and

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Haag, Scott Title: Director, Health Policy
Organization: APMA
Date: 01/20/2021
Comment:

On behalf of the members of the American Podiatric Medical Association (APMA), the national organization representing the vast majority of the nation’s estimated 15,000 doctors of podiatric medicine (DPMs), also known as podiatric physicians and surgeons, we appreciate the opportunity to offer our support for the National Coverage Decision (NCD) for Autologous Blood-Derived Products for Chronic Non-Healing Wounds. APMA is a member of the Alliance of Wound Care Stakeholders (the Alliance)

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Johnson, Martin Title: MD
Organization: Mayo Clinic Arizona
Date: 01/15/2021
Comment:
I have experience with this advanced wound care product. We are currently in the CED evaluation for this product at Mayo. The evidence associated with this product (Game et al, Sept, 2018, Lancet) was compelling for us to begin the CED evaluation. The product falls under the regenerative medicine pillar at the Clinic. We are very encouraged by the positive outcomes that we are seeing.
Jorden, David Title: CEO
Organization: Nuo Therapeutics, Inc.
Date: 01/20/2021
Comment:

NUO THERAPEUTICS, INC.
8285 El Rio, Suite 150
Houston, TX 77054

January 20, 2021

Tamara Syrek Jensen, J.D.
Director, Coverage and Analysis Group (CAG)
Centers for Medicare & Medicaid Services (CMS)
7500 Security Blvd.
Baltimore, MD 21244-1850

Re: Comments to Proposed Decision Memorandum for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R4)1

Dear Ms. Syrek

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Kelso, Martha Title: Chief Executive Officer
Organization: Wound Care Plus, LLC
Date: 01/19/2021
Comment:

Platelet Rich Plasma (PRP) is a true "trunk to bed" modality. As a mobile wound company that services thousands of wounds a week to aging or underserved populations in numerous states covering 6 MACS and 12 different Place of Service codes, modalities that do not need refrigeration or a temperature controlled environment are important and valuable. When we do not have access to advanced wound healing modalities, we incur the cost by spending healthcare dollars elsewhere. Weekly

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Lippert-Keck, Julianna Title: Medical Director
Organization: SoutheastHEALTH Wound and Hyperbaric Medicine
Date: 01/19/2021
Comment:
Re: Reapplix 3C Patch
Using the Reapplix 3C Patch we were able to demonstrate significant healing in chronic wound patients with diabetic foot ulcers despite numerous comorbidities. This included patients with chronic wounds greater than 5 years and had previously failed numerous other modalities including Negative Pressure Wound Therapy, surgeries, multiple dressing types, amniotic grafts and hyperbaric oxygen therapy. Healing with the 3C Patch was demonstrated despite ongoing patient

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Metcalfe, FACHE, Kevan Title: Chief Executive Officer
Organization: Memorial Hospital of Gardena
Date: 01/19/2021
Comment:

As I understand in my review of the AHRQ Technology Assessment and CMS proposed decision, there are two types of devices in the field that produce PRP; 1 type is indicated by FDA 510K clearance for use in orthopedics and other surgical settings and 1 type is indicated for use in chronic wounds.

Providing coverage for products or treatment systems that lack clinical evidence for efficacy in wound treatment can have unintended consequence of economically incentivizing usage “Off

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Nusgart, Marcia Title: Executive Director
Organization: Alliance of Wound Care Stakeholders
Date: 01/20/2021
Comment:

January 20, 2021

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Centers for Medicare and Medicaid Services
7500 Security Boulevard
Baltimore, Maryland 21244-1850

RE: Autologous Blood-Derived Products for Chronic Non-Healing Wounds - (CAG-00190R4)

Dear Director Syrek Jensen:

On behalf of the Alliance of Wound Care Stakeholders (“Alliance”), I am pleased to submit comments in support of the National Coverage Decision

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Radensky, Paul Title: Partner
Organization: MWE
Date: 01/20/2021
Comment:

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Medicare & Medicaid Services
Mail Stop # S3-02-01
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: Proposed Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R4)

Dear Ms. Jensen:

On behalf of Reapplix A/S (Reapplix), the manufacturer of the 3C Patch® System, I am pleased to submit comments on the

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Rappl, Laurie Title: PT, DPT, CWS
Date: 01/20/2021
Comment:

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
BalDmore, MD 21244-1850

Laurie M. Rappl, PT, DPT, CWS
Title: Physical and Certified Wound Specialist
205 Staffordshire Way
Simpsonville, SC 29681

Re: Proposed Decision Memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds

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Rappl, Laurie Date: 01/19/2021
Comment:

I am writing in support of coverage for PRP methods for healing open chronic wounds, specifically those that have an evidence base such as an FDA indication. My specific interest is in pressure ulcers. [PHI Redacted] Throughout these comments I will make most reference to one PRP, Aurix, as that is the one with which I am experienced. I once worked for the company but for 5 years have had no affiliation with them in any way.

[PHI Redacted]

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Rosendale, Martin Date: 12/22/2020
Comment:
The literature search utilized to formulate this decision appears to be exhaustive. There is little to add as far as published data. It has been known and documented for decades that properly formulated autologous platelet rich plasma is a powerful treatment for non-healing wounds. This decision is long overdue. CMS should be commended for having the courage to overturn a past NCD for non-coverage.
Scott, Ronald Title: M.D.
Date: 01/09/2021
Comment:
I am writing in support of the coverage decision for autologous blood derived products for non-healing wounds. I have over 30 years experience in the field of chronic wounds. I have used these products with great success and no negative side effects. These products have substantially better research and support than other currently approved modalities. I feel these products are also more cost effective than expensive modalities (e.g. HBO). I respectfully request that you approve these products.
Shaffett, Todd Title: DNP, FNP, CWS, FACCWS, DAPWCA, President
Organization: MedCentris Wound Healing Institute
Date: 01/19/2021
Comment:

As a medical practice that specializes only in wound medicine, we have been following the studies and reimbursement guidelines over the years related to platelet-rich plasma (PRP). We are very pleased to see the Centers for Medicare and Medicaid Services (CMS) propose new coverage guidelines. Although we have not participated in the CMS recognized studies, we have created our very own case studies that have had tremendous results on all wound types, but especially diabetic ulcerations,

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thomas, lynne Date: 12/26/2020
Comment:
It's time we began to look at medical help besides biologics. [PHI Redacted]
Veves, Aristidis Title: Professor
Organization: Beth Israel Deaconess Medical Center
Date: 01/14/2021
Comment:
This technique is strongly supported by a clinical trial which has been contacted according to the highest standards and showed beneficial effects for the management of diabetic foot ulceration. As a result, I recommend that the technique is covered by CMS
Walsleben, Matthew Title: Manager, Health Economics and Market Access
Organization: Terumo Blood and Cell Technologies
Date: 01/14/2021
Comment:

Tamara Syrek Jensen
Director, Coverage and Analysis Group
Center for Clinical Standards and Quality
Centers for Medicare & Medicaid Services
7500 Security Boulevard
Baltimore, MD 21244-1850

RE: National Coverage Analysis for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R4)

Dear Ms. Syrek Jensen,

Terumo Blood and Cell Technologies is a global leader in blood component, therapeutic apheresis, cellular and

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Williams, Ginger Title: Contract Medical Director
Organization: UPIC-MW/Covent Bridge Group
Date: 01/14/2021
Comment:

Comments are also being submitted via email in a more readable format:

Thank you for the opportunity to comment on CMS’ Proposed Decision (CAG-00190R4) to cover autologous platelet-rich plasma (PRP) for the treatment of chronic non-healing diabetic wounds, and to allow coverage of autologous PRP for treatment of all other chronic non-healing wounds to be determined by local Medicare Administrative Contractors (MACs).

In my role as Medical Director for CMS’ Unified

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Wright, Phillip Title: Pharmacist
Date: 01/20/2021
Comment:

As a pharmacist with 35 years experience in hospital and long term care I applaud CMS’ recent proposed decision to cover Autologous PRP (A-PRP) product for chronic wounds.

I had commented in April this would be a significant addition to the therapeutic armamentarium. I respectfully offer these considerations which I believe will enhance the policy. 

1. I am concerned that the current decision will lead to overuse by non-effective A-PRP systems The AHRQ study shows some

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Yousefpour, Makabisy Title: Podiatrist
Organization: Omega Podiatry Inc
Date: 01/14/2021
Comment:

Dear Sir or Madam,

I was given a chance to use Reapplix 3 C patch in my office as a trial on patients with severe, chronic non healing Diabetic ulcer. The wounds we used this product on closed in 6 months of weekly application. One specific pt that received the product, had the ulcer on his heel for over 3 years and weekly debridement and application of other expensive products had zero effect. The wound on that pt closed completely in 6 months and since then I have only seen him

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