Submitted Comments
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
August 18, 2021
The Alliance submitted letters to Congress supporting the Lymphedema Treatment Act (H.R. 3630), legislation that would provide comprehensive Medicare coverage for the treatment of patients with lymphedema or for the prevention of venous stasis ulcers resulting from venous insufficiency. "Lack of access to the clinically recognized treatments necessary to best care for these conditions leads to higher costs and poorer health outcomes, including recurrent infections, progressive degradation in condition, and, too often, disability," wrote the Alliance, recommending that Congress grant CMS the statutory authority to cover compression garments under the Medicare benefit.
August 10, 2021
On August 5, 2021, the Alliance submitted letters of support to for S. 2363 and its companion bill H.R.2356, both named the Better Wound Care at Home Act. Currently, implementation of the Medicare home health benefit for disposable negative pressure wound therapy (NPWT) limits patient access to this technology by imposing cumbersome billing regulations on the home health agencies (HHAs) and nurses who deliver care. By streamlining billing for HHAs onto the industry-standard claims form, eliminating burdensome time reporting requirements on home health nurses, and clarifying that payment to HHAs for disposable NPWT is for the device only, this legislation will improve access to a cost-effective, high-quality treatment for chronic wounds.
August 6, 2021
In advance of the Advisory Panel on Hospital Outpatient Payment public meeting on Aug. 23, 2021, the Alliance submitted written comments on specific provisions addressing payment for Cellular and/or Tissue Based Products for Skin Wounds (CTPs) and provided recommendations regarding CPT add-on codes and assignment of Ambulatory Payment Classifications (APCs) for the same size wound.
July 7, 2021
The Alliance delivered oral comments at the July 7, 2021 HCPCS Public Meeting for Non-Drugs and Non-Biologicals to elevate concerns about the CMS preliminary coding decision to defer applications from CTP ("skin substitute") products to a subsequent coding cycle. "Both the Alliance’s clinical associations and business entity members are concerned since this delay in decision making is impacting the commercialization of these products which can be devastating to small companies. For our clinician members, the delay in getting these products to market hampers their ability to use them as one of the treatments for their patients," the Alliance stated.
