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:

February 24, 2020

In a letter to CMS, the Coalition requested that  a Hospital Harm - Pressure Injury electronic clinical quality measure (eCQM) be included in the CY 2021 Inpatient Prospective Payment System rulemaking. Pressure injury rate transparency will lead hospitals to identify and implement best practice improvements which will reduce hospital-acquired pressure injuries, the Coalition noted.


December 19, 2019
The Coalition submitted inputs in response to CMS’ request for comments on surveys to improve the monitoring, outreach, and enforcement functions of the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) competitive bidding program (CBP). The Coalition provided recommendations on timing, frequency and transparency. 
See Coalition Comment
November 10, 2019

The Coalition submitted comments to WPS addressing the negative pressure wound therapy (NPWT) provisions of its Draft LCD for Wound Care. The Coalition flagged to WPS that NPWT utilization parameters in its policy conflict with existing DMEMAC policy. The Coalition questioned WPS’ rationale for including NPWT in its policy and  recommended that WPS eliminate the information on NPWT in its draft and refer providers to the DMEMAC NPWT Local Coverage Determination.
See Coalition Comments

September 27, 2019
The Coalition submitted comments to the DMEPOS Competitive Bidding Proposed Amendments included in CMS's CY 2020 End-Stage Renal Disease Prospective Payment System. In comments specifically focused on the provisions related to "Establishing Payment Amounts for New Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) Items and Services (Gap-filling)," the Coalition counseled CMS on a number of issues, flagging concerns and suggesting solutions:
  • CMS should not move forward with a final rule on payment methodologies for DMEPOS until further work is completed.
  • CMS should work with stakeholder groups and experts outside of CMS to ensure that the agency has a sufficient understanding of all costs associated with the provision of wound care products and other various types of technology classified under the DMEPOS benefit.
  • The Medicare “gap filling” payment determination methodology must be replaced as it is archaic, and does not result in reimbursement rates that allow access to medically necessary technology.
  • Fee schedules developed through comparable technology or technology assessments should be transparent and should include manufacturer’s input to ensure a thorough understanding of all associated costs.
  • CMS should institute an efficient and expeditious appeals process for manufacturers to challenge reimbursement levels established by this new pricing methodology and gap filling.
  • HCPCS public meetings should be limited to input on HCPCS codes, which are universal and as such should be focused on needs of all payers.
See Coalition comments
September 27, 2019
The Coalition submitted comments to CMS regarding its proposed CY2020 Hospital Outpatient Prospective Payment System Updates. Comments focused primarily on the provisions related to payment methodologies for cellular and tissue-based products for skin wounds (CTPs) and offered the following recommendations for CMS to take into consideration in the development process:
  1. CMS should move quickly in establishing the CTP payment reforms
  2. CMS must work with wound care stakeholders in creating whatever methodology is ultimately chosen
  3. CMS must be transparent in providing the data utilized.  
  4. CMS’s revised payment methodology should support reduced copays for Medicare beneficiaries.
  5. CMS needs to utilize the correct CTP cost information
  6. CMS must ensure that facilities are billing correctly for CTPs
  7. CMS must ensure that patients come first and they continue to have access to this valuable adjunctive therapy.
  8. When CMS proposed packaging, the Agency did not perform an impact analysis on payment rates or patient access. Therefore, CMS must conduct an impact analysis and provide its results in a transparent manner.
  9. CMS should take into consideration that there are a wide variety of patients with chronic wounds, that wounds heal differently and that treatment is individualized.
September 9, 2018
The Coalition submitted comments to CMS's End-Stage Renal Disease Prospective Payment System, which also covers the DMEPOS competitive bidding program. Comments focused on concerns surrounding the proposed calculation of single payment amounts (SPAs) and the gap-filling pricing methodology that applies when new technologies receive a new HCPCS code and CMS must establish a fee schedule amount for these new items.

Read Coalition comment
July 22, 2018
The Coalition submitted comments to CMS in response to the agency's request for comments on its “Pre-Claim Review Demonstration for Home Health Services.”  The Coalition urged CMS to withdraw the policy. Coalition comments expressed concern with about access issues and disruptions in patient care and noted the overall lack of implantation detail provided. “While it appears that CMS is trying to curb what it perceives is fraud and abuse in the home health sector, CMS should simply utilize data and resources it already has on hand to target specific types home health agencies whose behavior indicates that there may be fraudulent activity rather than implement a widespread demonstration project which will overburden and penalize home health agencies that have no record or patterns of fraud and abuse,” wrote the Coalition.

Read Coalition comment.
July 9, 2018
The Coalition submitted comments to CMS on the agency's DME Interim Final Rule- which addresses competitive bidding issues. Within the interim final rule, published in May, CMS temporarily increases the fee schedule rates from June 1, 2018, through December 31, 2018, for certain durable medical equipment (DME) items and services and enteral nutrition furnished in rural and non-contiguous areas (Alaska, Hawaii, and U.S. territories) of the country not subject to the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program. 

Read Coalition Comment
November 13, 2017
The Coalition sent a November 2017 letter to Rep. Marsha Blackburn (R-TN) in reference to H.R. 2445, the DMEPOS Access and Transparency Act of 2017, also known as the DATA Act of 2017. The proposed legislation would amend title XVIII of the Social Security Act to provide for a prior authorization process under the Medicare program for certain high-cost DMEPOS. The Coalition letter supported the Act and requested an amendment be offered to exclude negative pressure wound therapy (NPWT) from any prior authorization process. "While we generally support the DATA Act and its provisions to protect suppliers of durable medical equipment, prosthetics, orthotics and supplies (“DMEPOS”) from burdensome and potentially duplicative pre- and post-payment audits when they participate in a prior authorization program, the approach would unintentionally undermine the treatment protocol and quality of care for those patients who require Negative Pressure Wound Therapy,” wrote the Coalition.
View Coalition comment
September 11, 2017
The Coalition submitted comments to CMS on “CMS 1678-P, the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs.” Coalition comments addressed:
  • Issues with the methodology for packaging of skin substitutes (Cellular and/or Tissue Based Product for Skin Wounds, or CTPs)
  • Support for grandfathering in eight CTP products to the high-cost bucket of the newly established threshold between low and high costs
  • Request for CMS to work with stakeholders to obtain the proper data for creating appropriate APCs for the application of CTP products.
  • In response to CMS’s request for information on flexibility and efficiency opportunities to increase care, reduce costs and reduce burdens for clinicians and patients, the Coalition asked the agency to consider reform of the process it uses to assign new Healthcare Common Procedure Coding System (HCPCS) Level II billing codes to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS).
View Coalition Comment
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