The SVS has created a template to help members transmit comments to the Centers for Medicare & Medicaid Services (CMS) regarding proposed major adjustments in National Coverage Determination (NCD) 20.7, which covers carotid artery stenting (CAS).
The CMS proposal would adjust coverage for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting by expanding coverage to individuals previously only eligible for coverage in clinical trials and to standard surgical risk individuals by removing the limitation of coverage to only high-surgical-risk individuals.
It also would remove facility standards and approval requirements; add formal shared decision-making with the individual prior to furnishing CAS; and allow Medicare Administrative Contractor (MAC) discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.
The proposed decision was released July 11, opening a 30-day comment period that ends at 11:59 p.m. Aug. 10. The SVS-provided template for individual comments reads as follows:
As a vascular surgeon, I am concerned with the coverage expansion outlined in CMS’ Proposed Decision Memo relating to NCD 20.7. The decision to change coverage is premature and jeopardize patient safety. I respectfully request that CMS consider the following concerns and recommendations before finalizing any updates to NCD 20.7.
Recommendation 1. 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 2. 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 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.
Conclusion
I am in agreement with the Society for Vascular Surgery that the coverage expansion in CMS’ proposed decision memo regarding NCD20.7 is premature and jeopardizes patient safety. If, however, the agency moves forward to finalize the proposed expansion of coverage, the finalized memorandum should reflect the outlined recommendations.
Comments by individuals—or on behalf of a practice—should be submitted at vascular.org/CarotidNCD. At the close of the comment period, CMS will review each submission in advance of finalizing changes to NCD 20.7.
The SVS and its affiliated Patient Safety Organization (PSO)/Vascular Quality Initiative (VQI) remain concerned with the expansion of coverage outlined in CMS’ Proposed Decision Memo regarding NCD 20.7 and are in the process of creating its formal response.
SVS leaders want members to be aware of the issue and of some of the important topics the Society will raise during the comment period. They also encourage members to make their voices heard. The template highlights several critical points that will be featured in an upcoming SVS/PSO formal comment submission.
The proposed adjustments are a result of a formal request to CMS from the Multispecialty Carotid Alliance (MSCA) in late 2022 to reconsider NCD 20.7. In it, the MSCA urged CMS to update NCD 20.7 to cover PTA and CAS with embolic protection in patients with asymptomatic carotid artery stenosis greater than or equal to 70%, and in patients with symptomatic carotid artery stenosis greater than or equal to 50%; remove the requirement that patients are at high risk for carotid endarterectomy as well as facility and operator requirements; and leave coverage for any CAS procedure not described in the NCD to MAC discretion.
With that request, CMS opened an initial public comment period than ran from Jan. 12 to Feb. 11. During this period, the SVS and the PSO/VQI both submitted formal responses opposing reconsideration.
