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 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.
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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
September 11, 2017
The Coalition submitted comments to CMS on “CMS 1676-P: Medicare Program; Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2018.” The Coalition comments requested that CMS consider establishing office-based PE RUV’s for disposable Negative Pressure Wound Therapy (dNPWT). Comments also noted issues with codes and payment rates for NPWT services. The Coalition recommended that CMS assign direct cost inputs to disposable negative pressure wound therapy, which would allow the establishment of national payment rates for CPT codes 97607 and 97608 in the final Physician Fee Schedule (PFS) rule for CY 2018. 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).
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July 14, 2017
The Coalition submitted a letter to the DMEMAC medical directors requesting a delay of future surgical dressing LCD (L33831). The Coalition cited the LCD’s flaws in coverage criteria, in violation of current Medicare requirements and congressional intent outlined in the 21st Century Cures Act as significant flaws in the policy. Furthermore, the Coalition states in its comments that proposals in the LCD would eliminate coverage for hydrogel dressings used for stage II ulcers. The LCD includes other coverage restrictions that lack sufficient evidence to support them or that conflict with established standards of care as well.  Finally, the Coalition noted that the LCD does not provide any explanation for prohibiting the use of composite dressings to treat lightly exudative wounds, which also rubs contrary to the standard of care.
Letter Appendix
June 22, 2017
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.
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March 9, 2017
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. 
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March 9, 2017
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
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.
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January 26, 2017
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
December 25, 2016
The Coalition submitted comments to CMS on the Interim Final Rule for the Hospital Outpatient Prospective Payment Systems, CMS-1656-IFC. The Coalition states that under this payment model, hospitals would lose the ability to provide cellular/ tissue based products (CTPs) and Negative Pressure Wound Therapy (NPWT) products to patients. The Coalition recommends that CMS reconsider their choice to adopt the Medicare Physicians Fee Schedule (MPFS) so that hospitals may have the ability to provide NPWT and CTP products. 
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Email: marcia@woundcaremanufacturers.org 
Phone: 301.530.7846 
Fax: 301.530.7946
5225 Pooks Hill Road 
Suite 627 South 
Bethesda, Maryland 20814
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