Submitted Comments

Items Related to CTPs/(skin substitutes)

May 16, 2024

Oral Testimony at MAC "Listening Sessions" on LCDs/LCAs for use of CTPs in DFU/VLU

The Alliance provided oral testimony at the open public feedback sessions that each Medicare Administrative Contractor (MAC) held to collect stakeholder input on the proposed LCD "Skin Substitute Grafts/Cellular & Tissue-Based Products for the Treatment of DFU and VLU.” The Alliance voiced support for the proposed LCD language permitting additional applications beyond the 4 application limit and the extension of the 12-week treatment period based on medical necessity with documentation provided in the patients’ medical record. The Alliance also requested more transparency and consistency regarding the evidentiary bar being applied to determine if coverage will be provided - noting that there are a number published, peer-reviewed studies supporting a range of products that for unknown reasons were not included on the MACs’ list of evidence reviewed. Finally, the Allianced encouraged the MACs to ensure they provide enough time to implement the LCD, once finalized, so not to negatively impact patient care. The comments below were delivered to: CGS Administrators (5/16/2024); First Coast Service Options (5/23/2024); National Government Services (5/16/2024); Noridian Healthcare Solutions (J-E on 5/16/2024; J-F on 5/16/2024); Novitas Solutions (5/24/2024); Palmetto GBA (5/29/2024) and WPS Insurance Corporation (5/22/2024). More detailed written comments will be submitted by the June 8 submission deadline.

September 15, 2022

Remove Patient Access Barriers by Correcting Inadequacies in CTP Payments in the 2023 Hospital Outpatient Prospective Payment System Proposed Rule, Alliance of Wound Care Stakeholders Urges CMS

Sept. 19, 2022 – The Alliance of Wound Care Stakeholders urged the Centers for Medicare and Medicaid Services to update inadequate payment methodologies for cellular and/or tissue-based products for skin wounds (CTPs, or “skin substitutes”) to ensure appropriate access to care in the hospital outpatient/provider-based department (PBD) site of service. In comments submitted to CMS’s proposed 2023 Hospital Outpatient Prospective Payment System updates, the Alliance forwarded specific recommendations to correct policy and payment challenges that are negatively impacting access to CTPs in provider-based departments. These include...
Read Alliance News Release

September 8, 2022

Proposed Policy Changes in the 2023 Physician Fee Schedule Could Increase the Amputations and Infections for Patients with Wounds, Alliance of Wound Care Stakeholders Tells CMS

Sept. 7, 2022 - The Alliance alerted the Centers for Medicare and Medicaid Services (CMS) that changes to the way cellular and/or tissue-based products for skin wounds (CTPs, or “skin substitutes”) are coded and paid for in the physician office under the proposed 2023 Physician Fee Schedule will create barriers to care that could ultimately lead to increased amputations and infections for patients with chronic non-healing wounds. The Alliance urged CMS to delay implementation of the proposed provisions until patient access issues can be further studied. “Under the proposed 2023 policy, payments for CTPs and their application will simply not cover the costs to physician offices. Without adequate reimbursement, many physicians will no longer be able to afford to provide these medically necessary and successful advanced treatments to their patients. This would deprive patients these valuable treatment options which, in turn, could ultimately result in an increase in infections as well as amputations," the Alliance told CMS in submitted comments.
Read Alliance News Release

September 23, 2021

Alliance Alerts CMS to the Harmful Impacts of Wound Care Service Payment Reductions Proposed in the CY2022 Physician Fee Schedule and Hospital Outpatient Payment Rules

September 2021 – The Alliance of Wound Care Stakeholders voiced opposition to payment cuts that would negatively impact wound care providers and their patients in recent comments to the Center for Medicare and Medicaid Services’ (CMS) proposed CY2022 Physician Fee Schedule and proposed Hospital Outpatient Prospective Payment System (HOPPS) regulations. The Alliance challenged cuts to surgical procedures, physical therapy services, disposable negative pressure wound therapy and compression payment as well as provided recommendations to remove barriers to CTPs. The final regulations from CMS are expected to issue in November.
See Alliance News Release

August 23, 2021

CMS’ Advisory Panel on Hospital Outpatient Payment Unanimously Approves Alliance of Wound Care Stakeholders’ Recommendations that Would Correct Inadequacies in CTP Payments, Remove Barriers to Access

August 26, 2021 – At its public meeting on August 23, the Advisory Panel on Hospital Outpatient Payment unanimously approved two recommendations made by the Alliance of Wound Care Stakeholders that, if accepted and implemented by CMS, would positively impact wound care by correcting flaws in the payment that have negatively impacted reimbursement for cellular and tissue-based products for wounds (CTPs, also known as skin substitutes) and removing barriers to access for these important wound care products. While the Advisory Panel submits recommendations to CMS for consideration, the Agency is not obligated to move its recommendations forward. That is why now is the time for the wound care community to make its voice heard to CMS so that these recommendations are included in the OPPS policy as it is revised and finalized. Here's how.

See Alliance news release

October 16, 2020

Alliance Opposes Payment Cuts for Physician & Physical Therapy Services in CMS’ Proposed CY2021 Physician Fee Schedule

October 2020 – In comments submitted to the Center for Medicare and Medicaid Services (CMS), the Alliance of Wound Care Stakeholders voiced its opposition to payment cuts from five to nine percent for surgical procedures and nine percent for physical therapy services as CMS proposes in its CY2021 Physician Fee Schedule. The Alliance also called on CMS to (1) Adopt all of the American Medical Association’s RUC recommendations including updated E/M values in procedure codes with 10- and 90-day global periods; (2) Maintain a patient’s home as an originating site even when the public health emergency expires; (3) Include additional telehealth codes for physical therapy services, and more.

Additionally, in comments submitted to CMS' CY2021 Hospital Outpatient Prospective Payment System proposed updates, the Alliance flagged concerns with provisions dealing with coding and payment for Cellular and/or Tissue based Products for skin wounds (CTPs, also known as skin substitutes). The Alliance supported inclusion of synthetic CTPs in the definition of “skin substitutes” but expressed significant concerns with the Agency’s proposed establishment of a unique C code to define an entire class of non-branded products and the placement of these products in the OPPS high cost payment package.
See Alliance News Update Summarizing Comments