Submitted Comments
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The Alliance submitted comments to the FDA supporting its recently issued draft guidance "Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products.”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.
September 17, 2021
The Alliance submitted comments to CMS' proposed CY 2022 Hospital Outpatient Prospective Payment System expressing significant concerns with several provisions within the "skin substitute" section of the proposed rule. Comments specifically flagged issues and provided detailed recommendations surrounding:
The Alliance also encouraged CMS to adopt the Agency's Advisory Panel on Hospital Outpatient Payment recommendations to:
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- the definition and coding of synthetic resorbable skin substitutes,
- payment issues in provider based departments impacting Medicare beneficiaries access to skin substitutes (“cellular and/or tissue based products for skin wounds” or CTPs), and
- alternative payment methodology proposals for skin substitutes in the CY 2023 proposed rule.
The Alliance also encouraged CMS to adopt the Agency's Advisory Panel on Hospital Outpatient Payment recommendations to:
- assign the existing CPT add-on codes (15272 and 15276; 15274 and 15278) to an appropriate APC group allowing for payment and issue an exception for the payment of CTP application add-on codes, and
- assign the application of skin substitute codes for wounds/ulcers on the feet to the same APC group as the application of skin substitutes for wounds/ulcers on the legs.
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September 15, 2021
The Alliance submitted a letter to the Senate Finance Committee supporting legislation to amend the 2021 Consolidated Appropriations Act (CAA) through reconciliation to ASP+15% for skin substitute products before new requirements under Part B go into effect next year. "This small change would allow skin substitute products to remain in private physician offices while retaining the new reporting requirements instituted in the omnibus," the Alliance wrote, noting that this in turn would have "a dramatic impact on minority and underserved communities, which disproportionally suffer from skin ulcers and other skin-related complications that require skin substitute products. Without this change, it is likely that these populations will see access to early treatment dwindle, leading to more amputations, more hospitalizations and poorer health outcomes."
September 13, 2021
The Alliance submitted comments to the proposed CY 2022 Physician Fee Schedule supporting and encouraging implementation of provisions including: the delay of the Appropriate Use Criteria penalties, permitting Physician Assistants to bill for their services directly, and expansion of the Medicare Diabetes Prevention Program. Importantly, the Alliance also voiced concern with several specific provisions relevant to the wound care provider community, flagging the negative impacts of:
- proposed cuts to payment for surgical procedures and for physical therapy services
- proposed reduction to the payment of Disposable Negative Pressure Wound Therapy (dNPWT), CPT codes 97607 and 97608, by 22%, when performed in physician office settings
- proposed cuts to the CPT code fees for application of multilayer compression
- the creation of G codes for application of synthetic resorbable skin substitutes rather than use of Q codes
- the proposal that synthetic resorbable skin substitutes be treated as “incident-to” supplies in the physician office
September 7, 2021
The Alliance co-signed a letter to CMS with a coalition of other clinical associations and medical societies to oppose the payment rate cuts to specialists and adjustments to clinical labor pricing in the proposed 2022 Phyician Fee Schedule that, if implemented, "will jeopardize the delivery of care to Medicare beneficiaries." The letter outlined multiple recommendations to address concerns with the proposed clinical labor proposal and counseled CMS to "not implement this update for CY2022 and instead consider comments and publish an updated clinical labor proposal."
August 23, 2021
In addition to submitting written comments, the Alliance also presented its specific recommendations to the CMS Advisory Panel on Hospital Outpatient Payment at its Aug. 23, 2021 public meeting. Alliance recommendations focused on relieving barriers to access of CTPs (cellular and/or tissue-based products for skin wounds, also referred to as "skin substitutes"):
See Alliance news release
- CMS assign the existing CPT add-on codes (15272 and 15276; 15274 and 15278) to an appropriate APC group allowing for payment and issue an exception for the payment of CTP add-on codes
- CMS assign APCs for the same size wound regardless of anatomical location.
See Alliance news release
