Submitted Comments

February 27, 2024
In comments submitted to the FDA's proposed rule on classification of certain wound dressings classification of certain wound dressings and companion amendments, the Alliance requested that the Agency withdraw the policy for futher vetting, flagging the many "gaps and ambiguities" in the current policy, the reduced availability of wound dressing products that could result if the policy is implement, and the harm this could cause to patient care. "Though we agree with FDA that creating a classification regulation may provide added benefits regarding regulatory expectations, we believe the current proposal will create much greater confusion about requirements for wound dressings, and result in the unnecessary withdrawal of many important products from the market to the detriment of clinicians and their patients. These regulatory actions may result in clinicians using more antibiotic products, exacerbating the very resistance problems that FDA is trying to address through regulations on antiseptic-based wound dressings and washes. Therefore, the Alliance respectfully requests that FDA withdraw its current proposal, and if it desires to proceed, we ask that it publish a more detailed proposed rule, with companion guidance, addressing the points raised stakeholder comments," the Alliance wrote.

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February 20, 2024
The Alliance submitted comments supporting the intentions of FDA's draft guidance Use of Real-World Evidence (RWE) to Support Regulatory Decision-Making for Medical Devices, which would make use of real-world data and RWE for clinical trials and in expanding indications for use on already approved or cleared devices. We reminded the FDA that CMS and private payers do not accept this type of data for most products - including medical devices - for coverage purposes. As such, even if the FDA adopts/permits real world data/evidence for regulatory decision making, unless CMS and commercial payers also accept real world data/evidence, manufacturers would need to provide one type of evidence for the FDA and another for payers for coverage and payment purposes. The Alliance encouraged the FDA to dialogue with CMS and offered to serve as a resource and convener so that dialogue focused on  realistic and workable solutions can move forward.

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January 8, 2024
The Alliance co-signed a letter with aligned vascular and cardiology groups (American Venous Forum, Outpatient Endovascular and Interventional Society & others) to address Aetna's medical policy revision to Policy 0382 Intravascular Ultrasound, Policy 0295 Peripheral Atherectomy and Thrombectomy Devices, and Peripheral Vascular Intervention Clinical Guidelines. The letter flagged inconsistencies with medical society guidelines and current evidence and requested that the "experimental" designation from select interventions.

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December 18, 2023
The Alliance submitted a letter to the Congressional Joint Committee on Public Health supporting “An Act Relative to the Definition of Podiatry” (H.R.2150/S.1453) – legislation that would modernize the podiatric scope of practice law in Massachusetts to allow podiatrists to treat the foot, ankle, and lower leg.

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December 18, 2023
The Alliance submitted comments to the Partnership for Quality Measurement supporting expansion of the Global Malnutrition Composite Score in the Hospital Inpatient Quality Reporting (IQR) program from 65 years of age and older to 18 years of age and older. Inclusion of MUC2023-114 will ultimately improve patient care outcomes through standardized identification and treatment of malnutrition.

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December 8, 2023
As part of its advocacy collaboration with a large group of wound care/HBO stakeholders, the Alliance, submitted comments to CMS requesting an immediate correction to the payment rate for hyperbaric oxygen (“HBO”) therapy included in the 2024 Hospital Outpatient Prospective Payment System rule. In the final rule published in November, "CMS unexpectedly, and without explanation, implemented a reduction of over 40% to the CY 2024 OPPS payment rate for HBO therapy, compared to the CY 2023 OPPS payment rate. We believe that an error was made in the calculation and publication of this payment rate in the 2024 OPPS Final Rule, and we respectfully request that CMS take immediate action to issue a correction," the Alliance wrote, reminding the Agency that implementing this level of payment reduction through the final rule without the opportunity for public comment clearly violates the notice-and-comment rulemaking requirements of the Administrative Procedure Act. HBO has fixed costs "which cannot absorb the cut in the CY 2024 OPPS Final Rule," wrote the Alliance, emphasizing the negative patient care impacts as well as HBO site closures that could result. As part of its collaboration with a range of organizations in this space, the Alliance engaged independent reviewers to analyze the root cause of the drastic decrease in payment rate. The independent review analyzed outpatient claims and concluded that the final cost estimate that CMS provided with the final rule was most likely an error. The review was submitted with Alliance comments urging CMS to review its calculations of the cost, and thus the payment, for HBOT.

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September 13, 2023
The Alliance played a role in activating CGS Administratos to hold a formal “listening session” to collect stakeholder input, following the MAC's receipt of many communiques from many different stakeholders that Alliance outreach and advocacy had prompted. The Alliance testified at the Sept 13th “listening session” as well as helped mobilize a broad range of other voices from the wound care community to present and make their voices heard. 

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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:
  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.

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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.
See the Alliance's full comments below. 

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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.

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