Comments

Items Related to CTPs/(skin substitutes)

September 24, 2018

Comments to CMS CY 2019 Hospital Outpatient Prospective Payment System (OPPS)

The Coalition submitted comments to CMS in response to its proposed CY 2019 Hospital Outpatient Prospective Payment System (PPS) and Ambulatory Surgical Center Payment Systems.  Comments focused on provisions related to packaging and payment methodology for cellular and tissue-based products for wounds (CTPs), and pass through status for CTPs. The Coalition recommended that CMS:
  • move quickly in establishing the CTP payment reforms 
  • work with wound care stakeholders in creating whatever methodology is ultimately chosen 
  • be transparent in providing the data utilized 
  •  support reduced copays for Medicare beneficiaries. 
  • utilize the correct CTP cost information 
  • ensure that facilities are billing correctly for CTPs 
  • ensure that patients come first and they continue to have access to this valuable adjunctive therapy
  • conduct an impact analysis and provide its results in a transparent manner. 
  • 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 comment
September 11, 2017

Comments to CMS on the proposed CY 2018 Hospital Outpatient Prospective Payment System

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
December 25, 2016

Comments to CMS on Interim Final Rule with Comment Period on Hospital Outpatient Prospective Payment Systems (OPPS)

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. 
view coalition comment
September 6, 2016

Comments to CMS on Hospital Outpatient Prospective Payment System (PPS)

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.
view coalition comment
September 1, 2016

Testimony at FDA's Public Hearing on Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products

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.   
view coalition testimony
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
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