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 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. 
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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.
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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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November 21, 2016
The Coalition submitted comments to FDA’s General & Plastic Surgery Devices Panel of the Medical Devices Advisory Committee on FDA-2016-N-2147, recommending that antimicrobial wound care dressings in the FRO category, such as solids, cream/gel/ointment and liquid washes, be classified as Class II medical devices and regulated using the 510(k) premarket notification process. The Coalition based this recommendation on the fact that antimicrobial products in the FRO category fit the safety and effectiveness standards for class II while falling short of the standards for class III. 
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September 27, 2016
The Coalition submitted comments to the FDA on their draft guidance on the Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products, FDA-2015-D-3581, stating that despite a few concerns with the clarity of the FDA guidance document, the Coalition supports the FDA’s choices of terminology revolving around human cell and tissue products (HCT-Ps). The Coalition outlines concerns, however, with the FDA’s draft guidance on homologous uses for amnion tissue and the FDAs perception of “manufacturer objective intent.” The Coalition also addresses evidentiary and clarification concerns throughout the regulation.  
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September 6, 2016
The Coalition submitted comments to CMS on the CMS on Hospital Outpatient Prospective Payment System (OPPS) proposed rule, CMS-1656-P, on issues regarding the packing of CTPs. The Coalition states that CMS has been using flawed data to calculate the setting rate for CTPs, something the Coalition has informed CMS about for years. The Coalition states that CMS needs to require correct coding for CTPs, ensuring that claims forms reflect the correct number of units being billed for. Furthermore, the Coalition recommends that whether or not a product falls into the low cost bucket or high cost bucket should be a function solely of the size of the CTP, regardless of its anatomic location.
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