Knowledge Base Article

Q:

On January 19, 2021, CMS issued a final Decision Memo that included revised criteria for Medicare coverage of Transcatheter Edge-to-Edge Repair (TEER) for mitral regurgitation formerly known as Transcatheter Mitral Valve Repair (TMVR). When should our hospital start following the new criteria such as the requirements for treatment of functional (secondary) mitral regurgitation?

A:

Medicare is a huge bureaucracy and to change rules is not simply a snap of the fingers – there are manuals to update, Medicare contractors and providers to educate, and electronic systems to tweak. This means changes are not instantaneous and take some time to fully implement.

There are differences in the expected compliance with a coverage decision memorandum and a National Coverage Determination (NCD).  CMS addresses this in the Medicare Program Integrity Manual, Chapter 13, section 13.1.1:

A Decision Memo is not immediately binding on Medicare contractors though they are encouraged to consider it. Here is the language from the Medicare Program Integrity Manual, Chapter 13 concerning decision memos:

“Coverage Decision Memorandum- CMS prepares a decision memorandum before preparing the national coverage decision. The decision memorandum is posted on the CMS Web site, that tells interested parties that CMS has concluded its analysis, describes the clinical position, which CMS intends to implement, and provides background on how CMS reached that stance. Coverage Decision Memos are not binding on contractors or ALJs. However, in order to expend MR funds wisely, contractors should consider Coverage Decision Memo posted on the CMS Web site. The decision outlined in the Coverage Decision Memo will be implemented in a CMS-issued program instruction within 180 days of the end of the calendar quarter in which the memo was posted on the Web site.”

Providers need to bear in mind however, that the final NCD backdates the effective date of the changes to the date of the decision memo. The issue lies with the implementation date which is communicated in a CMS Transmittal once the NCD changes are finalized. Medicare Administrative Contractors (MACs) will not start enforcing the new rules until the implementation date, but then they will enforce rules for dates of service on and after the date of the decision memo. This means once the final update to the NCD is made and manualized, the effective date will revert to the date of the decision memo but following the new rules will be based on an implementation date.  Claims submitted on and after the implementation date, will follow the new guidelines for dates of service on and after January 19, 2021 (decision memo date).

Best practice is for providers to educate all key stakeholders on the changes in the decision memo and implement new requirements, such as documentation of persistent symptoms in a patient with functional mitral regurgitation despite maximally tolerated guideline-directed-medical therapy (GDMT), as quickly as possible. Until an implementation date is communicated, providers should not stop complying with the requirements of the current NCD if they are continuing to submit claims for the service.  Another option for providers is to follow the new criteria in the Decision Memo and hold claims until after the implementation date of the revised NCD.