Submitted Comments
April 29, 2022
The Alliance provided oral testimony at the April 29, 2022 public meeting to provide inputs to Novitas on its Draft LCD on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL35041).
For the purposes of this public meeting, the Alliance focused on four primary concerns:
1) Many of the statements and limitations in the policy do not have the scientific evidence to support them. Old evidence is cited and often the evidence cited contradicts statements in the policy that the evidence was used to support. 2) Utilization parameters in this draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided by Novitas. 3) There is conflicting, confusing and/or incorrect information contained in the draft LCD which is not only problematic but at times also clinically incorrect. 4)The Alliance flagged significant procedural issues with the release of this draft LCD - as Novitas did not engage any stakeholders nor convene a meeting of its CAC to create questions and discuss the evidence for this draft LCD.. The Alliance's perspective will be expanded in submitted written comments.
For the purposes of this public meeting, the Alliance focused on four primary concerns:
1) Many of the statements and limitations in the policy do not have the scientific evidence to support them. Old evidence is cited and often the evidence cited contradicts statements in the policy that the evidence was used to support. 2) Utilization parameters in this draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided by Novitas. 3) There is conflicting, confusing and/or incorrect information contained in the draft LCD which is not only problematic but at times also clinically incorrect. 4)The Alliance flagged significant procedural issues with the release of this draft LCD - as Novitas did not engage any stakeholders nor convene a meeting of its CAC to create questions and discuss the evidence for this draft LCD.. The Alliance's perspective will be expanded in submitted written comments.
April 28, 2022
The Alliance provided oral testimony at the April 28, 2022 public meeting to provide inputs to FCSO on its Draft LCD on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers (DL36377). In its brief oral comments, the Alliance focused on four primary concerns: (1) Many of the statements and limitations in the policy do not have the scientific evidence to support them; Old evidence is cited and often the evidence cited contradicts statements in the policy that the evidence was used to support. (2) Utilization parameters in this draft LCD seem arbitrary, will negatively impact patient care and are not supported in the evidence provided by Novitas. (3) There is conflicting, confusing and/or incorrect information contained in the draft LCD which is not only problematic but at times also clinically incorrect. (4) There are procedural issues with the release of this draft LCD as FCSO did not engage any stakeholders nor convene a meeting of its CAC to create questions and discuss the evidence for this draft LCD.. The Alliance's perspective will be expanded in submitted written comments to FCSO.
April 26, 2022
The Alliance submitted detailed responses to the questions posed by the FDA as it sought feedback and input heading into its April 28-29, 2022 Wound Healing Scientific Workshop. The Alliance provided responses to FDA's questions for wound care providers, questions for product developers/researchers and questions specific to reimbursement. Alliance staff, and many of our members, not only attended the virtual conference, but also participated as speakers.
April 3, 2022
The Alliance submitted a follow-on letter to CMS and its National Correct Coding Initiative (NCCI) Contractor continuing to urge consideration of our requests for edits. While through our advocacy efforts we successfully achieved an update to the NCCI manual in 2021 allowing for debridement and compression to be provided on the same day, the correlating changes to the edits table were not made at that time. The Aliance has again advocated for this change, emphasizing that "making this change without deleting the corresponding procedure-to-procedure edits does not sufficiently address the problem of Medicare beneficiaries being denied access to these important, limb and life-saving services. With the edits still in place, providers are discouraged from performing both services when performed on the same limb, despite the fact they are completely separate services with no overlap in the time, work, effort, or risk associated with the performance of the two. Making the above changes without deleting the corresponding procedure-to-procedure edits has caused confusion [and] uncertainty regarding how to interpret this." Together with the letter the Alliance submitted a table of the existing edits and our requested corrections so that the language in the Policy Manual be consistent with the edit table.
March 15, 2022
On March 15, the Alliance met with three divisions of CMS – Hospital and Ambulatory Policy Groups (Division of Practitioner Services and Division of Outpatient Care), Technology Coding and Pricing Group (Division of Coding and DRG) – to discuss how the inconsistent HCPCS code assignments for CTPs ("skin substitutes") have led to problematic issues in both the physician office setting and in hospital outpatient provider-based departments. The Alliance alerted CMS to the unintended consequences in the physician’s office and the hospital outpatient provider based departments when CMS began assigning “A” and “C” codes instead of the traditional Q codes to skin substitutes, and presented six specific recommendations for CMS consideration to bring consistency to coding for CTPs and synthetic CTPs and correct the unintended impacts being experienced under current coding policies.
To illustrate how the impact of decisions made in one division impacts the others, the Alliance also provided to CMS a detailed chart showing the chronology of skin substitute policies, providing context and timelines as to how HCPCS coding decisions have impacted the physician fee schedule and hospital outpatient policies. See Alliance presentation, recommendations and CTP policy chart below.
To illustrate how the impact of decisions made in one division impacts the others, the Alliance also provided to CMS a detailed chart showing the chronology of skin substitute policies, providing context and timelines as to how HCPCS coding decisions have impacted the physician fee schedule and hospital outpatient policies. See Alliance presentation, recommendations and CTP policy chart below.
March 1, 2022
The Alliance had opposed payment cuts in the CY2022 Physician Fee Schedule by collaborating with the Clinical Labor Coalition in letters and in our own submitted comments. Although several key payment cuts were minimized in the final rule as a result of this advocacy, the Coalition continues to address the range of issues that negatively impact physician practices, including steep Medicare cuts to numerous non-facility/office-based procedures. The Alliance signed on to a new March 2022 letter from the Coalition aimed to muster additional Congressional support to find a legislative fix. “The physician practices that have increased wages for their clinical labor staff over the past 20 years, to keep up with the market, with no corresponding rate increases in the PFS, are now suffering paralyzing cuts from a policy intended to align the wages with current market,” the letter states.
February 8, 2022
The Alliance submitted a letter requesting that Noridian revise it Wound and Ulcer Care LCD (L38904) and LCA (A58567) to ensure that that CPT and HCPCS code descriptors are correct and to update incorrect/outdated terminology within the policy. The Alliance submitted a detailed list of suggested revisions.
January 18, 2022
Led by APMA, the Alliance signed on with more than 18 other organizations to a letter to CMS’ Center for Clinical Standards and Quality addressing issues with LCD/LCA development, CAC issues and the overall lack of transparency and uniformity in setting reimbursement for products used in office-based site of care. The letter submits four specific recommendations for CMS consideration to solve current challenges.
December 1, 2021
The Alliance spoke at the Dec. 1-2, 2021 HCPCS Public Meeting in support of the CMS HCPCS Workgroup’s preliminary coding decision to establish three new Level II HCPCS codes for non-pneumatic compression devices. "Including disparate devices into the same HCPCS code would severely limit the ability of CMS and other interested parties to collect data and assess the utilization, cost, efficacy and clinical outcomes of these new devices. Therefore, we are in agreement with the creation of three new K codes since it will allow CMS to establish appropriate product segmentation thereby avoiding issues related to data collection and analysis," the Alliance told the Workgroup.
The Alliance also submitted comments voicing its concern with the recent assignment “A” codes for “synthetic” skin substitute products and requesting more transparency in this decision making process.
The Alliance also submitted comments voicing its concern with the recent assignment “A” codes for “synthetic” skin substitute products and requesting more transparency in this decision making process.
November 18, 2021
The Alliance submitted comments to the FDA supporting its recently issued draft guidance "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.” Comments urged the Agency to utilize RWE as a “top programmatic priority” in the regulatory process and supported use of data from registries, claims, and electronic health records in the evaluation of drugs and biologics.
