Open Comment Period - CMS' Decision Regarding NCD 20.7
The comment period closed on August 10, 2023. Thank you to all who participated!
The SVS invites members to submit comments to the Centers for Medicare & Medicaid Services (CMS) on its proposed national coverage determination on percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting.
The Centers for Medicare & Medicaid Services (CMS) received (and accepted) a complete formal request to reconsider NCD 20.7 from the Multispecialty Carotid Alliance (MSCA). In their request, the MSCA urged CMS to update NCD 20.7 to:
- Cover PTA and CAS with embolic protection in patients with asymptomatic carotid artery stenosis ≥ 70% and in patients with symptomatic carotid artery stenosis ≥ 50%;
- Remove the requirement that patients are at high risk for CEA;
- Remove the facility and operator requirements; and
- Leave coverage for any CAS procedure not described in the NCD to MAC discretion.
This resulted in CMS opening an initial public comment period that ran from 01/12/2023 - 02/11/2023. On July 11, CMS released a Proposed Decision Memo regarding its reconsideration of NCD 20.7, which included the following adjustments in coverage for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with Stenting:
- Expanding coverage to individuals previously only eligible for coverage in clinical trials;
- Expanding coverage to standard surgical risk individuals by removing the limitation of coverage to only high surgical risk individuals;
- Removing facility standards and approval requirements;
- Adding formal shared decision-making with the individual prior to furnishing CAS; and
- Allowing MAC discretion for all other coverage of PTA of the carotid artery concurrent with stenting not otherwise addressed in NCD 20.7.
With the release of its proposed decision, CMS has opened another 30-day comment period, which runs through August 10, 2023. The SVS and its affiliated PSO/VQI remain concerned with the expansion of coverage outlined in CMS’ Proposed Decision Memo regarding NCD 20.7 and have submitted a formal response as of Friday, Aug. 4, 2023.
The purpose of this communication is to make SVS members aware of the issue, provide insight on some of the important topics the SVS will raise during the comment period, and encourage you to make your voice heard on this issue. For your convenience, below is sample language for your use in preparing individual comments. The sample language highlights several critical points that are featured in the SVS/PSO formal comment submission.
The comment period is now closed. Thank you for your comments!
Please Note: The sample language highlights several critical points featured in the SVS/PSO formal comment submission. CMS could discount template language that is simply copied and pasted into a comment. You are encouraged to use this language as a guideline to formulate your own comment.
Sample Language for Comment Formation
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 jeopardizes 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.