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:

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.   
view coalition testimony
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. 
view coalition comment

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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February 19, 2016
The Coalition submitted comments to CMS on the Medicare Administrative Contractors (MAC) contracting process, as per CMS’ request for information regarding the “Awarding and the Administration of Medicare Administrative Contractor Contracts (CMS 1653-NC).” The Coalition cites past and present accountability and transparency issues with the MACs/PDAC. The Coalition advocates for the extension of this request for information to the PDAC, instead of just the MACs. The Coalition outlines possible incentive systems for exceptional MAC performance, specific metrics or evaluation criteria to measure the quality of MAC service, and the level of information regarding MAC performance that should be public record. 
view coalition comment
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