Submitted Comments
September 11, 2023
In comments to CMS' proposed 2024 Hospital Outpatient Prospective Payment System (HOPPS) rate update, the Alliance submitted five specific policy recommendations to help correct payment methodology flaws and inappropriate APC assignments that have impacted access to CTPs ("skin substitutes") and created barriers to care in hospital outpatient departments. The Alliance reminded CMS that the Agency's own Advisory Panel on Hospital Outpatient Payment has recommended that CMS adopt these policy updates:
- enable HOPDs be reimbursed for an adequate amount of CTP products for larger wounds so that they do not need to absorb the cost or refer patients out by assigning the existing CPT® add-on codes (15272, 15274, 15276, and 15278) and HCPCS codes (C5272, C5274, C5276, and C5278) to appropriate APC groups allowing for separate payment and issue an exception to separately pay for these add-on codes.
- equalize the payment for CTP application for wounds/ulcers of the same size no matter the location by assigning the CPT and HCPCS codes for the same size wound, regardless of anatomical location on the body, to the same APC groups.
- assign all CTPs with either HCPCS codes of Q or A to the low-cost APC groups until a manufacturer provides cost information to CMS.
- realign both the high-cost and low-cost application procedure codes to higher paying APC groups that reflect the current average sales prices of all CTPs. Manufacturers are required to submit average sales prices, and this pricing should be used to map to an appropriate APC for all CTPs, whether they are issued a HCPCS A code or Q code.
- do not assign CTPs that are not in sheet form to any APC group, because these products are not allowed to use the current application codes of HCPCS codes 15271-15278; C5271- C5278; which drive the APC group assignment.
September 11, 2023
The Alliance submitted detailed comments to CMS' proposed 2024 Medicare Physician Fee Schedule focused on a range of issues including:
- Payment methodologies for CTPs (skin substitutes): the Alliance provided recommendations and workable alternative solutions to CMS’s proposed bundling of CPTs, encouraging the agency to utilize and enforce the submission of ASP for all CTPs and publish all CTPs’ ASPs in the data file.
- Valuation of hyperbaric oxygen under pressure (HCPCS code G0277): the Alliance urges CMS to adopt the RUC recommendations for direct PE inputs for G0277 that the clinical labor intra-service time should be 30 minutes, consistent with the code descriptor, and not 15 minutes as proposed.
- Clinical Labor Updates: the Alliance again voiced its opposition to the Clinical Labor Update and its significant cuts in reimbursement that undermine the long-term financial viability of physician practices and patient seniors’ access to critical treatments and procedures.
September 8, 2023
The Alliance engaged CMS Coverage & Analysis Group senior staff to alert them the concerning patient care issues surrounding the Novitas/First Coast Service Options/CGS Admistrators local coverage determinations and local coverage articles on CTPs ("skin substitutes") for the treatment of diabetic food ulcer and venous leg ulcer. Requested CMS intervention to delay implementation or withdraw the LCDs/LCAs completely. "These LCDs provide the latest example of contractor policies that have raised substantive and procedural concerns within the clinical community. While the Alliance believes there is a need for a more thorough discussion with CMS and the MACs regarding these and other issues, we write today only with the goal of avoiding significant and impending harm to patients that would result from implementation of these LCDs and LCAs. We implore CMS to intervene," the Alliance wrote.
September 5, 2023
Via submitted comments and testimony to CMS’ Advisory Panel on Hospital Outpatient Payment, the Alliance submitted five recommendations to correct inadequacies in payments for CTPs ("skin substitutes") and remove barriers to access. If accepted and implemented by CMS in upcoming Hospital Outpatient Prospective Payment System updates, these recommendations would positively impact wound care by correcting flaws in the payment that have negatively impacted reimbursement for CTPs and removing barriers to access for these important wound care products. The recommendations were overwhelmingly approved by the Panel and elevated in its report to CMS:
- Assign the existing CPT® add-on codes (15272, 15276, 15274, 15278) and HCPCS codes (C5272, C5276, C5274, C5278) to appropriate APC groups allowing for separate payment and issue an exception to separately pay for these add-on codes.
- Assign the CPT and HCPCS codes for the same size wound, regardless of anatomical location on the body, to the same APC groups.
- Assign all new CTPs with both Q and A HCPCS codes, to the low-cost APC groups until a manufacturer provides cost information to CMS.
- Realign both the high-cost and low-cost application procedure codes to higher paying APC groups that reflect the current average sales prices of all CTPs. Consistently publish and use the ASP of all CTPs.
- Don’t assign CTPs that are not in sheet form (e.g., gel, powder, ointment, foam, liquid, or injected) to any APC group because these products are not allowed to use the current application codes of 15271-15278 or C5271-C5278, which drives the APC group assignment.
August 30, 2023
Submitted “Request for Immediate Response” letters to Novitas, FCSO & CGS medical directors regarding their LCDs/LCAs on CTPs (skin substitutes) for the treatment of diabetic foot ulcers/venous leg ulcers that were issued as final with substantive new provisions that were not contained in the draft issued for comment, that failed to reflect stakeholder comments, and that contained arbitrary utilization parameters and other restrictive provisions that created significant barriers to quality patient care. The letters flagged numberous clinical issues and procedural process concerns as well as included a detailed collection of Alliance members’ clinical and operational questions in need of clarity.
August 29, 2023
The Alliance submitted comments to CMS's proposed 2024 Home Health Prospective Payment System Rate Update, with a focus on provisions related to the scope of the benefit and payment for lymphedema compression treatment items. The Alliance recommended inclusion a mechanism to allow for fair payment to health professionals on the time used for measurement, fitting and training around clinical compression garments, bandages, and accessories. Alliance comments also addressed provisions that include home health quality reporting program and wound care.
August 24, 2023
The Alliance sent a second letter to Guidewell Source, the parent company of Medicare Administrative Contractors Novitas Solutions and First Coat Service Options, reminding Guidewell's CEO and General Counsel to the negative patient care implications of the final LCDs/LCAs on Skin Substitutes for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers. The letter, also sent to Novitas and FCSO, highlighted the detailed list of operational questions in need of clarity, and requested that the MACs withdraw these coverage policies and develop new ones that is more clinically accurate and reflective of wound care community-wide stakeholder input.
August 21, 2023
The Alliance submitted comments CMS on its proposed outline of a new Transitional Coverage of Emerging Technologies (TCET) pathway for certain devices designated as “breakthrough” by the FDA. While the Alliance applauds efforts by CMS bring medically necessary and valuable products to market faster, the proposal does not go far enough, the Alliance told CMS. "This proposal contains a lengthy evidence development process without a predictable or transparent coverage pathway – which was purportedly the purpose of the TCET being issued. There is no accountability being placed on the Agency to ensure the process is speedy and timeframes for review are met." Read more,
July 28, 2023
The Alliance signed on to a letter with 20+ other health/medial associations to the Centers for Medicare and Medicaid Innovation (CMMI) requesting an extension to comment on its Request for Information seeking stakeholder input regarding the design of future episode-based payment models. The RFI was published on July 18 - just days after the draft 2024 Medicare Physician Fee Schedule and Outpatient Prospective Payment System proposed rules were released for comment.
The RFI required comments within 30 days for this large and important payment issue – which we and others did not feel was sufficient time to vet within our various memberships to consolidate and provide substantive feedback. CMMI said it could not extend comment period but will provide additional opportunities to comment in rulemaking. In issuing the RFI, CMS is looking to address the inefficiencies in traditional Medicare fee-for-service, where providers are paid for each item or service, which may drive volume over value and fragment care. CMS indicated that the Innovation Center intends to design, implement, and evaluate future episode-based payment models with a focus on five strategic objectives, including advancing health equity and driving accountable care.
The RFI required comments within 30 days for this large and important payment issue – which we and others did not feel was sufficient time to vet within our various memberships to consolidate and provide substantive feedback. CMMI said it could not extend comment period but will provide additional opportunities to comment in rulemaking. In issuing the RFI, CMS is looking to address the inefficiencies in traditional Medicare fee-for-service, where providers are paid for each item or service, which may drive volume over value and fragment care. CMS indicated that the Innovation Center intends to design, implement, and evaluate future episode-based payment models with a focus on five strategic objectives, including advancing health equity and driving accountable care.
July 24, 2023
The Alliance submitted comments to the FDA on its "Decentralized Clinical Trials for Drugs, Biological Products and Devices: Draft Guidance for Industry, Investigators and Other Stakeholders." Overall supporting the guidance and its intent to expand access to diverse locations/populations, the Alliance raised several areas of concern surrounding whether the policy would have the impact that the Agency is striving to achieve. Our comments offer a series of recommendations, as well as highlight specific provisions that would benefit from additional clarity.
