Submitted Comments

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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• LCD
• Medicare Administrative Contractors (MACs)
• Negative Pressure Wound Therapy (NPWT)

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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• LCD
• Medicare Administrative Contractors (MACs)
• Negative Pressure Wound Therapy (NPWT)

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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• LCD
• Medicare Administrative Contractors (MACs)
• Negative Pressure Wound Therapy (NPWT)

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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• CMS
• CTPs/(skin substitutes)
• Negative Pressure Wound Therapy (NPWT)
• Physicians Fee Schedule
• Prospective Payment System

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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• Antimicrobials
• FDA

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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• FDA

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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• CMS
• CTPs/(skin substitutes)
• Prospective Payment System

The Coalition submitted comments to the FDA’s General and Plastic Surgery Panel of the Medical Devices Advisory Committee on FDA-2016-N-2147, stating that FRO products in the class II category should require 510(k) clearance and special controls to ensure their safety and effectiveness. The Coalition also advocated for the FDA establishing sub-categories within the FRO classification, outlining what these categories may include. Finally, the Coalition recommended a re-establishment of the safety and efficacy of products in the FRO category. 
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• Antimicrobials
• FDA

The Coalition provided oral testimony at the FDA's Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (CTPs), acknowledging many FDA recommendations that the Coalition agrees with regarding minimal manipulation and homologous use. However, the Coalition also outlined issues with the process the FDA uses in issuing guidance documents. This process, argues the Collation, would benefit from significantly increased stakeholder input. Furthermore, the Coalition recommends that the FDA go through an appropriate regulatory process when they wish to make substantive changes within a given guidance document.   
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• CTPs/(skin substitutes)
• FDA

The Coalition submitted comments to CMS on the CY 2017 Home Health Prospective Payment System (PPS) Rate Update; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements. The Coalition noted that its members had been involved and closely monitoring the creation of the Patient Access to Disposable Medical Technology Act of 2016. That Act became section 504 of the Consolidated Appropriations Act of 2016. Because Coalition members were so closely monitoring that process, the Coalition was very aware of the original congressional intent of these statutes as they relate to add-on payments to home health agencies (HHAs) and Negative Pressure Wound Therapy (NPWT). The Coalition clarified in comments that the intent of these statues was not for home health agencies to absorb to entire cost of care for a patient requiring NPWT in the home. The Coalition recommended that CMS revise their proposal to match the Congressional intent and language revolving around disposable NPWT devices in home health settings. 
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• CMS
• Negative Pressure Wound Therapy (NPWT)
• Prospective Payment System