Submitted Comments
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. We called on the Agency 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.
November 9, 2021
The Alliance submitted comments to Medicare Administrative Contractors Noridian and CGS to oppose provisions in their draft Pneumatic Compression Devices LCD (DL33829) stating that the use of pneumatic compression devices for the treatment of critical limb ischemia (CLI) is not “reasonable and necessary” for purposes of Medicare reimbursement.
November 1, 2021
The Alliance sent a letter to Massachusetts legislators supporting legislation to modernize podiatric scope of practice in the state. “An Act Relative to the Definition of Podiatry" would allow podiatrists to treat the foot, ankle, and lower leg.
October 14, 2021
The Alliance submitted comments in response to CMS' proposal to repeal the Medicare Coverage of Innovative Technology (MCIT) and the Definition of “Reasonable and Necessary” rules. In its notice of repeal, CMS had solicited stakeholder input prior to developing a new, separate policy addressing expedited coverage pathways for innovative technologies. The Alliance urged CMS to quickly move forward in issuing a new policy and provided a detailed list of issues and questions to consider as that proposed rule is developed. Comments also reiterated Alliance concern with the "reasonable and necessary" provisions of the original MCIT rule and discouraged inclusion of such provisions in the new rule.
October 3, 2021
The Alliance submitted a letter to the National Correct Coding Initiative (NCCI) contractor reiterating that current edits addressing compression, CTP application and debridement are inconsistent with peer-reviewed literature and do not allow the accurate allocation of resources for clinical procedures to deliver the most effective clinical approaches for treatment of diabetic foot ulcers and venous ulcers. A follow-up to the Alliance's June comments, this October letter requests a meeting with the NCCI contractor and with appropriate CMS staff to further discuss the issues.