Submitted Comments

The Coalition is the respected and credible unified voice of manufacturers of wound care products and technologies. We advocate and educate policymakers, legislators, public and private payers and the other relevant entities to ensure patient and provider access to wound care products and services. We address a broad range of issues and product categories. Our submitted comments are below:

November 21, 2016
The Coalition submitted comments to FDA’s General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on FDA-2016-N-2147, recommending that antimicrobial wound care dressings in the FRO category, such as solids, cream/gel/ointment and liquid washes, be classified as Class II medical devices and regulated using the 510(k) premarket notification process. The Coalition based this recommendation on the fact that antimicrobial products in the FRO category fit the safety and effectiveness standards for class II while falling short of the standards for class III. 
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September 27, 2016
The Coalition submitted comments to the FDA on their draft guidance on the Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products, FDA-2015-D-3581, stating that despite a few concerns with the clarity of the FDA guidance document, the Coalition supports the FDA’s choices of terminology revolving around human cell and tissue products (HCT-Ps). The Coalition outlines concerns, however, with the FDA’s draft guidance on homologous uses for amnion tissue and the FDAs perception of “manufacturer objective intent.” The Coalition also addresses evidentiary and clarification concerns throughout the regulation.  
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September 6, 2016
The Coalition submitted comments to CMS on the CMS on Hospital Outpatient Prospective Payment System (OPPS) proposed rule, CMS-1656-P, on issues regarding the packing of CTPs. The Coalition states that CMS has been using flawed data to calculate the setting rate for CTPs, something the Coalition has informed CMS about for years. The Coalition states that CMS needs to require correct coding for CTPs, ensuring that claims forms reflect the correct number of units being billed for. Furthermore, the Coalition recommends that whether or not a product falls into the low cost bucket or high cost bucket should be a function solely of the size of the CTP, regardless of its anatomic location.
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September 1, 2016
The Coalition submitted comments to the FDA’s General and Plastic Surgery Panel of the Medical Devices Advisory Committee on FDA-2016-N-2147, stating that FRO products in the class II category should require 510(k) clearance and special controls to ensure their safety and effectiveness. The Coalition also advocated for the FDA establishing sub-categories within the FRO classification, outlining what these categories may include. Finally, the Coalition recommended a re-establishment of the safety and efficacy of products in the FRO category. 
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September 1, 2016
The Coalition provided oral testimony at the FDA's Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (CTPs), acknowledging many FDA recommendations that the Coalition agrees with regarding minimal manipulation and homologous use. However, the Coalition also outlined issues with the process the FDA uses in issuing guidance documents. This process, argues the Collation, would benefit from significantly increased stakeholder input. Furthermore, the Coalition recommends that the FDA go through an appropriate regulatory process when they wish to make substantive changes within a given guidance document.   
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August 26, 2016
The Coalition submitted comments to CMS on the CY 2017 Home Health Prospective Payment System (PPS) Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. The Coalition noted that its members had been involved and closely monitoring the creation of the Patient Access to Disposable Medical Technology Act of 2016. That Act became section 504 of the Consolidated Appropriations Act of 2016. Because Coalition members were so closely monitoring that process, the Coalition was very aware of the original congressional intent of these statutes as they relate to add-on payments to home health agencies (HHAs) and Negative Pressure Wound Therapy (NPWT). The Coalition clarified in comments that the intent of these statues was not for home health agencies to absorb to entire cost of care for a patient requiring NPWT in the home. The Coalition recommended that CMS revise their proposal to match the Congressional intent and language revolving around disposable NPWT devices in home health settings. 
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August 22, 2016
The Coalition submitted comments to CMS regarding Medicare Program; Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures; Proposed Rule, recommending that CMS address their backlogged appeals process and minimize improper denials of Medicare contractor appeals. The Coalition suggested accomplishing this by means of proposals to improve broad audits and contractor reviews. Further, the Coalition advocated for a prohibition on contractors collecting provider overpayments until the appeals process has been exhausted on all levels. The Coalition also supported:
  • Mandatory education and training for all providers and Medicare contractors
  • The creation of a process for interested stakeholders to challenge published case precedent
  • The assurance that attorney adjudicators will have experience in Medicare coverage, coding, and payment and that those attorneys, too, receive continuous education and training on these issues. 
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August 22, 2016
The Coalition submitted comments to CMS on CMS-1651-P: Medicare Program Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment, stating that while the Coalition agrees with some provisions that CMS has adopted regarding the competitive bidding program, significant problems remain. Specifically, the Coalition is concerned that CMS does not do a sufficient job vetting vendors for the competitive bidding program or ensuring the implementation of quality standards and products. The Coalition also takes issue with CMS’s decrease in reimbursement for NPWT, as the ramifications of that decrease can have devastating impacts on rural communities.  
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August 8, 2016
The Coalition submitted comments to Cigna Government Services (CGS) on draft Local Coverage Determination (LCD) for Application of Skin Substitute for Wounds, of Lower Extremities (DL36690), stating that CGS has abandoned the widely accepted CTP nomenclature despite being the first company to recognize it. Specifically, CGS and has reverted to using the scientifically incorrect term “skin-substitutes” in their LCD title language. The Coalition believes that this problematic language causes confusion among the clinical community, resulting in clinical inaccuracies and coverage guidance issues. 
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May 9, 2016
The Coalition submitted comments to CMS on to CMS on CMS -1670-P -Medicare Program; Part B Drug Payment Models, requesting that CMS withdraw the proposal entirely. The Coalition believes that the payment model lacks any evidence supporting its methodology. Furthermore, the regulation was proposed without taking stakeholder input into account. The Coalition believes that CMS has not sufficiently proved that their methodology will save costs or improve the quality of care, citing many gaps in the proposal. 
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