Comments

Items Related to CTPs/(skin substitutes)

June 8, 2024

Comments and Recommendations to MACs to Improve LCDs/LCAs on CTPs in diabetic foot & venous leg ulcers

The Coalition submitted comments to the medical directors of each Medicare Administrative Contractor (MAC) with specific recommendations to improve the local coverage determinations/local coverage articles on "Skin Substitute Grafts/ Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers." Coalition recommendations spanned a broad range of issues, including:

Evidence: the Coalition recommended that the MACs provide the GRADE criteria or protocols utilized to evaluate CTP evidence prior to this policy becoming finalized
Reconsideration processes: the Coalition recommended that the MACs remove the product-by-product evaluation from the LCD and instead place in an Appendix or in the LCA so the entire LCD does not have to be reopened every time new evidence is reviewed; urged the MACs to provide an efficient and timely process for manufacturers to submit additional published evidence or other data to support movement of products located within the non-covered Group 3 to the covered Group 2 list.
Implementation timeline: the Coalition recommended that patients on a current plan of care protocol when the policy is implemented be grandfathered so they are able to complete the plan of care established by their clinician based on current LCD language.

See comments

September 11, 2023

Comments to Proposed 2024 Hospital Outpatient Prospective Payment System (HOPPS)

The Coalition submitted comments to CMS's proposed 2024 Hospital Outpatient Prospective Payment System (HOPPS) focused on the CTPs (skin substitutes) section of the proposed rule, flagging patient access issues as well as inconsistency in the way products are being treated in both payment and coverage depending on the HCPCS code being issued despite the products all being categorized as skin substitutes. The Coalition recommended that CMS withdraw its policy to package payment and instead utilize ASP +6 for all skin substitutes and publish all data in the pricing data file. "Given the mandatory submission of ASP for all skin substitutes, CMS should use the data that is already being provided to it to form the payment for any given skin substitute," the Coalition wrote. To address inequities in the current payment system that continue to create barriers to access, the Coalition elevated the following recommendations - each of which was endorsed by the Agency's Advisory Panel on Hospital Outpatient Payment:

assign the existing CPT® add-on codes (15272, 15276, 15274, and 15278) and HCPCS codes (C5272, C5276, C5274, and C5278) to appropriate APC groups allowing for separate payment; and issue an exception to separately pay for these add-on codes.
assign the CPT and HCPCS codes for the same size wound, regardless of anatomical location on the body, to the same APC groups.
assign all new CTPs with both Q and A HCPCS codes to the low-cost APC groups until a manufacturer provides cost information to CMS.
realign both the high-cost and low-cost application procedure codes to higher paying APC groups that reflect the current average sales prices of all CTPs.
not assign CTPs that are not in sheet form (e.g., gel, powder, ointment, foam, liquid, or injected) to any APC group.

Read Coalition Comments

September 11, 2023

Comments to draft 2024 Medicare Physician Fee Schedule

The Coalition submitted comments to CMS' proposed 2024 Medicare Physician Fee Schedule voicing opposition to the Agency's proposal to treat CTPs (skin substitutes) as “incident to supplies” when furnished in non-facility settings and to include the costs of these products as resource inputs in establishing practice expense RVUs for associated physician’s services, rather than reimburse them separately. The Coalition outlined specific concerns, requested that CMS withdraw the proposal, and recommended instead that CMS maintain and enforce ASP pricing – "the most consistent pricing for CTPs that should and can be utilized across payment settings."
Read Coalition Comments

September 30, 2022

Letter to Guidewell Urging Withdrawal of Novitas & FCSO's LCDs on DFU/VLU

The Coalition sent a letter to Guidewell Source, the parent company of Medicare Administrative Contractors Novitas and First Coat Service Options, requesting that the two MACs withdraw their proposed Local Coverage Determinations (LCDs) Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041 and DL36377) and Local Coverage Articles (LCAs): Billing and Coding: Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DA54117 and DA57680). The Coalition informed Guidewell that many of the provisions in the policies are contrary to clinical practice guidelines and research, and in several instances are in conflict with the very evidence cited in the draft policies. The Coalition also urged Guidewell to intervene because the draft LCDs and LCAs violate several statutory provisions – which is problematic given the negative impact to patient care and access.
See the Coalition's letter

September 24, 2022

Comments to Novitas and FCSO Draft LCD on Skin Substitutes for DFU/VLU

The Coalition submitted comments to Novitas and First Coast Service Option expressing its major concerns with the proposed LCD (DL35041/DL36377) and LCA (DA54117/DA57680) on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The comments follow initial submission of detailed feedback in May 2022and oral testimony at MACs' August public meeting. The Coalition again raised the following objections in its submitted comments:

The policies are not in the best interest of patients.
The policies are not supported by clinical evidence or guidelines. Evidence has been omitted from the policy review. What has been utilized is either not the most currently available, or is used in such a way that is contradictory to the points Novitas/FCSO is trying to make.
There is NO new evidence to support the movement of more than 40 products from the covered to the non-covered list.

See Coalition Comments

September 27, 2019

Comments to CY2020 Hospital Outpatient Prospective Payment System

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:

CMS should move quickly in establishing the CTP payment reforms
CMS must work with wound care stakeholders in creating whatever methodology is ultimately chosen
CMS must be transparent in providing the data utilized.
CMS’s revised payment methodology should support reduced copays for Medicare beneficiaries.
CMS needs to utilize the correct CTP cost information
CMS must ensure that facilities are billing correctly for CTPs
CMS must ensure that patients come first and they continue to have access to this valuable adjunctive therapy.
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.
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

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

November 27, 2015