CMS Updates CGM Documentation Guidance
Dear Supplier,
CMS has recently provided additional guidance to the DME MACs regarding documentation expectations for demonstrating continued medical need for Continuous Glucose Monitors Supplies (CGMs) under the applicable Local Coverage Determination (LCD).
As a reminder, in order to support continued need for CGM supplies, suppliers must ensure that medical record documentation supports that the beneficiary has had an in-person or Medicare-approved telehealth visit with their treating practitioner at least every six (6) months following the initial CGM prescription. This visit must include an assessment of the beneficiary’s adherence to the CGM regimen and overall diabetes treatment plan.
Key Clarification
The updated guidance emphasized that simply listing a CGM on the patient’s medication or equipment list is not sufficient to meet the continued need requirement. Medicare auditors are specifically looking for clear documentation in the medical record indicating that the patient is actively using the CGM and that its use is being monitored and evaluated by the treating practitioner.
Examples of Acceptable Documentation
While not all-inclusive, the following are examples of documentation that may support compliance with the LCD continued need requirement:
- A statement from the treating practitioner (MD, DO, NP etc.) confirming that the patient has a CGM and continues to use their CGM
- Documentation referencing CGM data downloads reviewed by the treating practitioner
- Actual CGM reports or downloaded data incorporated into the beneficiary’s medical record
Supplier Expectations
Suppliers should:
- Best practice is to ensure documentation is obtained and retained prior to claim submission
- Confirm that records reflect active CGM use, not just that the patient was seen
- Work with prescribing practitioners to obtain sufficient detail in clinical notes to meet audit expectations
Failure to meet these documentation requirements may result in claim denials or audit findings. It is important to note that this clarification does not constitute a revision to the applicable Local Coverage Determination (“LCD”) or associated Policy Article, and therefore no specific effective date applies. Rather, this guidance reflects CMS’s interpretation of existing requirements. Accordingly, any claim, regardless of date of service, may be subject to medical review and evaluated for compliance consistent with this guidance, and suppliers should ensure that all supporting documentation meets these clarified expectations.
Please note that no formal publication or official notice of this clarification was issued. Rather, ACU-Serve identified this change in review posture through observed patterns in recent audit results and subsequent direct inquiries to the applicable DME MACs following receipt of those findings. This guidance therefore reflects current enforcement trends and interpretive positions communicated by the MACs, notwithstanding the absence of a formally published policy update. Trend observe is current as of the date of the article or memorandum.
Reminder:
Suppliers are reminded that progress notes authored solely by clinical pharmacists or dieticians do not satisfy the six (6) month follow-up evaluation requirement for purposes of Medicare coverage of CGMs.
To meet this requirement, the beneficiary must have an in-person or Medicare-approved telehealth visit with the treating practitioner. Under current statutory and regulatory authority, clinical pharmacists and dieticians are not recognized as treating practitioners for purposes of fulfilling this requirement.
Accordingly, documentation reflecting interactions exclusively with these providers, absent a qualifying evaluation by a treating practitioner, will be deemed insufficient to establish compliance with the continued need requirement.
If you have questions regarding this guidance or documentation expectations, please contact at [email protected]
Disclaimer: This communication is provided for informational purposes only and is intended to highlight observed audit trends and clarifications. It does not replace, supersede, or modify any written guidance issued by the DME MACs, CMS, or other regulatory authorities, nor is it intended to constitute legal advice. Suppliers remain solely responsible for independently interpreting and complying with the applicable LCDs, Policy Articles, and all governing Medicare requirements, and should rely on official CMS and MAC publications in conjunction with their own legal or compliance counsel, as appropriate.