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:

July 3, 2020
The Coalition submitted comments to CMS's COVID-19 Public Health Emergency Second Interim Final Rule that provided additional policy and regulatory revisions to provide flexibility during the pandemic. The Coalition focused on issues facing the wound care supplier and manufacturing communities, with specific recommendations for CMS to consider. These included:
  • Delaying the DME competitive bidding program;
  • Streamline Medicare billing for disposable negative pressure wound therapy (NPWT) furnished at home onto the standard form used by home health agencies;
  • Prioritizing DMEPOS suppliers’ access to personal protective equipment for treating COVID-19 patients in their homes;
  • Waiving all pre-authorization requirements for DMEPOS patients during the emergency period;
  • Extending appeals deadlines, postponing Medicare audits, and defering overpayment recoupment so that DMEPOS providers and suppliers can focus on caring for patients and provide meaningful products and services to impacted patients;
  • Adding select codes for negative pressure wound therapy (NPWT) using disposable, non-durable medical equipment to the eligible telehealth list.

See Coalition Comment
June 26, 2020
Following a February 2020 comment letter to CMS requesting that  a Hospital Harm - Pressure Injury electronic clinical quality measure (eCQM) be included in the CY 2021 Inpatient Prospective Payment System rulemaking, the Coalition sent a June follow-on communique to the Agency noting "While this measure was included in the proposed CY 2020 rulemaking, it was not included in the final CY 2020 Inpatient PPS rule nor was it included in the recent CY 2021 proposed rule.  We are disappointed that the Agency did not include these measures and hope that the Agency reconsiders placing it into the CY 2021 final rule or at the very least propose its inclusion in the CY 2022 proposed rule."

See Coalition Comment

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.

SEE COALITION LETTER 

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.
READ COALITION COMMENTS
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
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