The Society for Vascular Surgery (SVS) and its affiliated Patient Safety Organization (PSO)/Vascular Quality Initiative (VQI) have submitted a formal response to the Centers for Medicare & Medicaid Services (CMS) regarding its proposed national coverage determination on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.
The move would expand coverage to individuals previously only eligible for coverage in clinical trials; to standard surgical risk patients by removing coverage limitations to only high surgical risk individuals; remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing carotid stenting; and allow Medicare Administrative Contractors (MACs) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.
In a letter dated 4 August, Joseph L. Mills, MD, SVS president, on behalf of the SVS executive board, and Jens Eldrup-Jorgensen, MD, medical director of the SVS PSO, state that the SVS and its affiliated PSO “remain concerned” with the expansion of coverage outlined in CMS’ Proposed Decision Memo regarding NCD 20.7. They go on to submit a series comments for consideration in advance of the CMS issuing a final decision memorandum. These include the negative impact on patient safety, the premature nature of the decision given that CREST-2 [Carotid revascularization and medical management for asymptomatic carotid stenosis trial] is still underway, the impact to the elderly patient population, the “substantial and lengthy” learning curve for transfemoral carotid artery stenting (TF-CAS), and the lack of a registry participation requirement.
Due to these concerns, Mills and Eldrup-Jorgensen write that they “urge CMS to revise its proposed decision memo relating to NCD 20.7” and set out a series of recommendations. These are as follows:
- Recommendation 1. Mandate utilization of a standardized “Shared Decision Making” tool that would be designed in collaboration with applicable medical specialty societies and/or other relevant stakeholders.
- Recommendation 2. Revise the proposed decision memo to emphasize the collection of real-time data, paired with the continuation of the credentialing process and requirements for reporting standards. These elements are critical for ensuring a high degree of patient safety.
- Recommendation 3. Revise the proposed decision memo to include a definition for “Qualified Physician” and demonstrated core competency standards relating to PTA of the carotid artery concurrent with stenting. CMS should work with relevant stakeholders to develop the core competency standards.
Mills and Eldrup-Jorgensen conclude: “The SVS believes the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations. SVS will continue to actively promote quality and safety for vascular patient care through its published guidelines, appropriate care documents, PSO-VQI Registry and Initiatives such as the Vascular Verification Program. All practitioners caring for patients with vascular disease are encouraged to become familiar with and to utilize them. SVS will continue to develop these resources and make them available.”
Read the full response here.
