Submitted Comments
- CTPs: The Alliance commended CMS efforts to improve program integrity in the reimbursement of CTPs. The Alliance has advocated over the years for CMS to fix flaws and inadequacies in the OPPS bundled payment methodology and applauds the Agency’s current efforts to do so. The Alliance supports CMS’ proposal to pay for CTPs separately, as unbundling will finally enable hospital outpatient departments to be reimbursed for CTP products for larger wounds as well as receive equalized payment for the application of CTPs regardless of a wound’s anatomic location – fixes that the Alliance has elevated to CMS for years. Comments addressed details of CMS’s proposed “incident to supplies” payment methodology and the creation of new reimbursement categories for CTPs based on FDA regulatory categories versus a single payment approach.
- Blood and Blood Derived Products payment
- Point of Care Imaging (POCI) reimbursement under Software as a Service (SaaS) frameworks
- Total Contact Casting (TCC) coding and payment policy clarification/correction
- Therapeutic Shoes for Patients with Diabetes access barriers
- Price Transparency
Alliance comments to the Physician Fee Schedule also recommended:
- Efficiency Adjustment withdrawal
- Blood and Blood Derived Products payment adjustment
- Hyperbaric Oxygen Therapy coding methodology
- Point of Care Imaging (POCI) reimbursement under Software as a Service (SaaS) frameworks
- Therapeutic Shoes for Diabetic Patients access improvements
The Alliance submitted a letter of support for Massachusetts State House Bill 2407 / Senate Bill 1542, “An Act Relative to the Definition of Podiatry,” that would update and modernize the podiatric scope of practice law in Massachusetts to allow podiatrists to treat the foot, ankle, and lower leg.
HHS issued a Request for Information in May soliciting recommendations on specific regulations that should be eliminated "to lower healthcare costs, reduce burdens on physicians, and address the prevalence of chronic disease." The Alliance engaged its multiple workgroups to identify specific areas for inclusion and submitted to HHS a detailed chart of regulations with corresponding recommendations across specific guidance. These included recommendations to:
- Correct several problematic NCCI edits including Total Contact Cast (TCC)
- Revise Coverage w Evidence Development (CED) processes and the Transitional Coverage for Emerging Technologies (TCET) pathways – as they are cumbersome and do not achieve the desired results of bringing product to market faster.
- Remove burdens to the Medicare process for obtaining therapeutic shoes for patients with diabetes that currently creates unnecessary delays in care.
- Issue clear, enforceable guidance to Medicare Advantage Programs requiring that their coverage and documentation requirements align with, and are no more restrictive than, those established under Medicare Fee-for-Service (FFS) as is required in regulation.
- Update provisions for lymphedema compression treatment coverage to enable payment for clinicians to measure and fit lymphedema compression garments, and more...
The Alliance submitted comments to the National Quality Forum (NQF) request for stakeholder input on its proposed updates to its Serious Reportable Events (SRE) List. The Alliance focused on a problematic update to SRE 15: "Patient Harm Associated With a Stage 3 Pressure Injury, Stage 4 Pressure Injury, or Deep Tissue Injury Acquired After Admission." The 2025 update identifies 27 areas as serious reportable events and expands all SREs to all healthcare settings. The Alliance recommended not only that SRE 15 “not be expanded to other healthcare settings since it is totally different and unique from others that are currently on the list” but also that it be removed from the list entirely. “Pressure ulcers/pressure injuries can be a normal physiologic response to the underlying co-morbid illnesses and acute hemodynamic factors and are not in the same category as operating on the wrong patient or wrong site, an overdose of radiotherapy, or insemination with the wrong sperm -- events that are clearly identifiable to a provider.” If NQF is not willing to delete SRE 15 from the 2025 list, the Alliance recommended that it limit the healthcare settings to only hospital/acute care and eliminate ambulatory/outpatient, post-hospital/subacute and home care. “Given the delay from event to presentation of a pressure ulcer/pressure injury, it will be impossible to reliably link them to an outpatient healthcare encounter,” the Alliance wrote.
- Withdrawal of FDA Proposed Rule re: Reclassification of Certain Antimicrobial Wound Dressings
- Changes to Prior Authorization processes
- Lessening of burdens within Medicare’s Therapeutic Shoe Program for Patients with Diabetes
- Fixes to problematic payment provisions for CTPs in the Hospital Outpatient Prospective Payment System
- Expanded adoption of real-world evidence (RWE) and updates to Coverage with Evidence Development
- National Correct Coding Initiative; Audit Reform; Data & Reporting Processes that are Duplicative or Overly Complex; plus additional opportunities for deregulation and reform...
