Coalition of Wound Care Manufacturers

Comments

Items Related to Medicare Administrative Contractors (MACs)

June 8, 2024

Comments and Recommendations to MACs to Improve LCDs/LCAs on CTPs in diabetic foot & venous leg ulcers

The Coalition submitted comments to the medical directors of each Medicare Administrative Contractor (MAC) with specific recommendations to improve the local coverage determinations/local coverage articles on "Skin Substitute Grafts/ Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers." Coalition recommendations spanned a broad range of issues, including: 

  • Evidence: the Coalition recommended that the MACs provide the GRADE criteria or protocols utilized to evaluate CTP evidence prior to this policy becoming finalized
  • Reconsideration processes: the Coalition recommended that the MACs remove the product-by-product evaluation from the LCD and instead place in an Appendix or in the LCA so the entire LCD does not have to be reopened every time new evidence is reviewed; urged the MACs to provide an efficient and timely process for manufacturers to submit additional published evidence or other data to support movement of products located within the non-covered Group 3 to the covered Group 2 list.
  • Implementation timeline: the Coalition recommended that patients on a current plan of care protocol when the policy is implemented be grandfathered so they are able to complete the plan of care established by their clinician based on current LCD language. 

See comments
September 30, 2022

Letter to Guidewell Urging Withdrawal of Novitas & FCSO's LCDs on DFU/VLU

The Coalition sent a letter to Guidewell Source, the parent company of Medicare Administrative Contractors Novitas and First Coat Service Options, requesting that the two MACs withdraw their proposed Local Coverage Determinations (LCDs) Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041 and DL36377) and Local Coverage Articles (LCAs): Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117 and DA57680). The Coalition informed Guidewell that many of the provisions in the policies are  contrary to clinical practice guidelines and research, and in several instances are in conflict with the very evidence cited in the draft policies. The Coalition also urged Guidewell to intervene because the draft LCDs and LCAs violate several statutory provisions – which is problematic given the negative impact to patient care and access.
See the Coalition's letter
September 24, 2022

Comments to Novitas and FCSO Draft LCD on Skin Substitutes for DFU/VLU

The Coalition submitted comments to Novitas and First Coast Service Option expressing its major concerns with the proposed LCD (DL35041/DL36377) and LCA (DA54117/DA57680) on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The comments follow initial submission of detailed feedback in May 2022and oral testimony at MACs' August public meeting. The Coalition again raised the following objections in its submitted comments:
  • The policies are not in the best interest of patients.
  • The policies are not supported by clinical evidence or guidelines. Evidence has been omitted from the policy review. What has been utilized is either not the most currently available, or is used in such a way that is contradictory to the points Novitas/FCSO is trying to make.
  • There is NO new evidence to support the movement of more than 40 products from the covered to the non-covered list.
See Coalition Comments
June 22, 2017

Comments to Wisconsin Physician Services (WPS) addressing its draft LCD on Wound Care (DL37228)

The Coalition submitted comments to WPS on wound care draft LCD (DL37228). The comments focus on the arbitrary utilization parameters WPS set for Negative Pressure Wound Therapy (NPWT), stating that parameters do not even necessarily need to be set at all. Furthermore, the Coalition comments that WPS lacks transparency in their decision-making process, and that they should include stakeholder input when crafting their regulations.
View Coalition Comment
March 9, 2017

Comments to First Coast Service Option draft LCD on wound care

The Coalition submitted comments to FCSO on wound care draft LCD (DL37166). The comments focus on the lack of coverage for disposable Negative Pressure Wound Therapy (dNPWT), stressing inaccuracies with CPT coding descriptors and a lack of sufficient evidence to claim that the dNPWT is neither reasonable nor necessary. The Coalition comments that that FCSO should cover dNPWT, providing reasons based on evidence and congressional intent. 
View Coalition Comment
March 9, 2017

Comments to Novitas draft LCD on wound care

The Coalition submitted comments to Novitas on draft wound care LCD (DL35125). The comments focus on the lack of coverage for disposable Negative Pressure Wound Therapy (dNPWT), the arbitrary and unnecessary utilization parameters for NPWT, and the lack of transparency in decision-making process for changing the LCD.  The Coalition cites evidence that anchors its argument in place. 
View Coalition Comment
February 16, 2017

Testimony at FCSO at public meeting on draft wound care LCD

The Coalition provided oral testimony at the FSCO public meeting on February 16 on wound care draft LCD (DL37166). Comments focused on disposable negative pressure wound therapy (dNPWT), concerning utilization parameters and incorrect information contained in the draft LCD.
View Coalition Comment
January 26, 2017

Testimony to Novitas at open meeting to collect comments on its draft LCD on wound care

The Coalition provided oral testimony to Novitas Solutions during its public meeting on wound care draft LCD (DL35125). The Coalition’s comments focus on the drastic difference between the draft LCD compared to its original and that Novitas gives no clear indications as to the reasons for this change. The Coalition also cited specific issues with the arbitrary and non-evidence based utilization parameters for disposable Negative Pressure Wound Therapy. Finally, the Coalition expressed its concerns regarding the confusing and contradictory information contained throughout the LCD, stating that the LCD must be changed and clarified before finalization.
View Coalition Comment
August 8, 2016

Comments to Cigna Government Services on DRAFT Local Coverage Determination (LCD) for Application of Skin Substitute for Wounds, of Lower Extremities (DL36690)

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. 
view coalition comment
November 27, 2015

Comments to Palmetto GBA on draft LCD “Application of Skin Substitutes to Lower Extremity Chronic Non Healing Wounds”

view coalition comment
October 22, 2015

Testimony at Palmetto GBA public meeting on draft LCD “Application of Skin Substitutes to Lower Extremity Chronic Non Healing Wounds"

view coalition presentation
August 25, 2015

Comments to Palmetto draft LCD on Debridement of Wounds

view coalition comment
July 24, 2015

Coalition comments to Palmetto draft LCD for Application of Skin Substitutes to Lower Extremity Chronic Non Healing Wounds (DL36123)

view coalition comment
May 23, 2015

Comments to First Coast Service Option on draft LCD for Application of Skin Substitute Grafts for Treatment of DFU and VLU of Lower Extremities

view coalition comment
November 6, 2014

Comments to Novitas on draft skin substitute LCD

view coalition comment
July 25, 2014

Comments on the First Coast Service Option’s draft LCD, “Application of Bioengineered Skin Substitutes for the Treatment of Diabetic and Venous Stasis Ulcers of the Lower Extremities”

view coalition comment
November 7, 2013

Comments to Novitas Solutions on Wound Care and Bioengineered Skin Substitutes

view coalition comment
July 18, 2013

Comments to Novitas Solutions on Wound Care and Bioengineered Skin Substitutes

view coalition comment
April 29, 2013

Comments to Cigna Government Services on CTPs

view coalition comment
March 13, 2013

Comments to First Coast on Cellular and/or Tissue Derived Products for Wounds (CTPs)

view coalition comment
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