Submitted Comments

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

• CMS
• CTPs/(skin substitutes)

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.

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• CMS
• Prospective Payment System

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.

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• CMS
• demonstration project

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. 

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• CMS
• Competitive Bidding
• DMEMACs

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.
View Coalition comment

• Negative Pressure Wound Therapy (NPWT)
• Prior Authorization
• Legislation

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).

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

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).
View Coalition Comment

• CMS
• HCPCS
• Negative Pressure Wound Therapy (NPWT)
• Physicians Fee Schedule

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 21^st 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

• DMEMACs
• LCD
• Surgical Dressing

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

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

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