Response to Comments: Glucose Monitors – DL33822

Many commenters expressed their support for the proposed revisions of the CGM coverage criteria which included coverage for beneficiaries with diabetes who use basal insulin and non-insulin users who have a history of problematic hypoglycemia. The commenters offered support for the removal of the criterion requiring frequent adjustments in diabetes treatment regimen on the basis of BGM/CGM results. Additionally, the commenters appreciated the clarification on the allowance for telehealth visits for initial evaluation and confirmation of adherence to CGM. 

The DME MAC Medical Directors would like to thank the individuals and/or associations for taking the time to submit detailed comments and offering support for the vast majority of the language in the proposed Glucose Monitors LCD.

One commenter asked for coverage of a CGM for their specific combination of rare medical condition(s). 

The DME MACs analyze the available evidence and write LCDs to address when items are reasonable and necessary for the vast majority of Medicare beneficiaries. There may be situations in which individual consideration is appropriate for rare medical conditions and those situations can be addressed via the appeals process. 

One commenter asked for coverage of a CGM under their Medicare Advantage Plan.

As outlined in CMS Medicare Managed Care Manual (Pub. 100-16) Chapter 4, Section 10.12, “[Medicare Advantage] plans are required to ‘provide coverage of, by furnishing, arranging for, or making payment for, all services that are covered by Medicare Part A and Part B’ (see 42 CFR 422.101(a)), which includes coverage of durable medical equipment, prosthetics and supplies.”

Several commenters requested coverage of CGM for all beneficiaries with diabetes, including those who do not use insulin or do not have a history of hypoglycemia. One of the commenters also requested CGM coverage for beneficiaries with pre-diabetes. The commenters did not submit any additional evidence for consideration.

The DME MACs analyzed the best available evidence and found insufficient evidence to support coverage of CGMs for beneficiaries with pre-diabetes or diabetes who are not treated with insulin or without a history of hypoglycemia. 

Several commenters expressed concern that the proposed coverage criteria would restrict coverage of CGM. 

The proposed and now finalized Glucose Monitors LCD is expanding coverage of continuous glucose monitors to beneficiaries with diabetes who utilize insulin <3 times per day and beneficiaries with diabetes not using insulin who have a history of problematic hypoglycemia.  

One commenter requested the Glucose Monitors LCD be updated to include the new, revised, and reinstated CGM HCPCS codes for January 2023. 

The Glucose Monitors LCD was updated separately from this formal LCD reconsideration process to incorporate HCPCS coding changes which were effective January 1, 2023. 

Several commenters requested treating practitioners be allowed to verify beneficiary adherence to CGM by using objective downloads from the device in lieu of an in-person or telehealth treating practitioners visit. The commenters indicated this approach would be consistent with documentation requirements for high utilization of blood glucose monitor (BGM) supplies. Some of these commenters noted concerns over the possibility of increased health disparities this requirement could impose.  

The DME MACs conducted a literature analysis and thorough review of existing clinical practice guidelines, professional society recommendations, and the Centers for Disease Control and Prevention (CDC) diabetes care schedule on this topic. The evidence strongly supports maintaining the requirement for treating practitioner visits (in-person or via telehealth) every six months to assess adherence to the CGM regimen and diabetes treatment plan in order to improve health outcomes for Medicare beneficiaries with diabetes. 

One commenter suggested treating practitioners (in-person or telehealth) visits to confirm CGM adherence be conducted every six months for the first year and then yearly thereafter.

The DME MACs conducted a literature analysis and thorough review of existing clinical practice guidelines, professional society recommendations, and the CDC diabetes care schedule on this topic. The evidence strongly supports maintaining the requirement for treating practitioner visits (in-person or via telehealth) every six months to assess adherence to the CGM regimen and diabetes treatment plan in order to improve health outcomes for Medicare beneficiaries with diabetes. 

One commenter asked the DME MACs to consider a pharmacist-driven CGM program allowing the pharmacists to document beneficiary adherence to the CGM. 

The DME MACs conducted a literature analysis and thorough review of existing clinical practice guidelines, professional society recommendations, and the CDC diabetes care schedule on this topic. The evidence strongly supports maintaining the requirement for treating practitioner visits (in-person or via telehealth) every six months to assess adherence to the CGM regimen and diabetes treatment plan in order to improve health outcomes for Medicare beneficiaries with diabetes. After review of the available literature, there is insufficient evidence to support pharmacist-driven CGM programs for this purpose. 

One commenter discouraged the removal of the requirement for treating practitioners visits either in-person or via Medicare approved telehealth every six months to document CGM adherence. The commenter indicated that simple review of downloaded CGM data cannot take the place of treating practitioner visits and had concerns over who would be interpreting the CGM data. 

The DME MACs agree with the concerns raised by this commenter and have retained the requirement for treating practitioner visits (in-person or via telehealth) every six months to document adherence. 

Several commenters submitted general statements asking for CGM coverage to be expanded. 

The proposed and now finalized Glucose Monitors LCD is expanding coverage of continuous glucose monitors to beneficiaries with diabetes who utilize insulin <3 times per day and beneficiaries with diabetes not using insulin who have a history of problematic hypoglycemia.  

Several commenters requested the removal of the criterion requiring the CGM be prescribed in accordance with the FDA indications for use. These commenters questioned the reasoning for inclusion of this criterion and indicated they were unaware of any requirement in statute, regulation, or CMS manuals restricting use of devices to FDA indications. One commenter also noted that treatment of hypoglycemia does not fall within the FDA indications of CGM. 

Per CMS Program Integrity Manual (Pub. 100-08) Chapter 13, Section 5.3 (in relevant part):
“If the item or service is regulated by the FDA, and determined by the MAC to be reasonable and necessary, information regarding the use of the item or service subject to the FDA indication, as applicable, shall be included.”

Additionally, the DME MACs reviewed the available peer-reviewed literature and evidence-based practice guidelines, and found insufficient evidence to support off-label coverage of non-adjunctive CGM as a standalone device for diabetes treatment decision making in beneficiaries who are pregnant, or who have end-stage renal disease and require dialysis.

Non-adjunctive CGM devices are FDA indicated to replace blood glucose testing for diabetes treatment decisions and for the detection of hyper- and hypoglycemic episodes. Adjunctive CGMs are not intended to be used for making therapeutic adjustments, but rather provide an indication of when a fingerstick glucose test may be required.

One commenter requested CGM coverage for all pregnant beneficiaries with diabetes.

The DME MACs reviewed the available peer-reviewed literature and evidence-based practice guidelines, and found insufficient evidence to support extending coverage of CGM for all pregnant beneficiaries with diabetes.

Several commenters requested clarification that the criterion requiring the CGM be prescribed in accordance with FDA indications would not lead to loss of CGM coverage for a beneficiary who initially qualified for CGM and later develops a condition which is contraindicated based on the FDA indications for use. 

The Glucose Monitors LCD has one continued coverage criterion which must be met: “Every six (6) months following the initial prescription of the CGM, the treating practitioner conducts an in-person or Medicare-approved telehealth visit with the beneficiary to document adherence to their CGM regimen and diabetes treatment plan.” There is no requirement for the treating practitioner to reconfirm the initial coverage criteria are met for continued coverage. 

Many commenters requested the policy be revised to allow for CGM supplies to be billed in 90-day increments as opposed to being limited to 30-day increments. Commenters noted this billing change would be consistent with billing allowances for insulin infusion pump supplies and BGM supplies. Several of these commenters also requested clarification on where this requirement is found in the CMS manuals, statute, or regulation.  

Per CMS Claims Processing Manual (Pub. 100-04) Chapter 20, Section 110.4, suppliers are required to submit claims on a monthly basis unless a [CMS] policy that allows billing at a different frequency applies. CMS has created HCPCS codes that only allow monthly billing of a CGM supply allowance. HCPCS codes K0553 (for dates of service on or before 12/31/2022), A4238 (for dates of service on or after 1/1/2023), and A4239 (for dates of service on or after 1/1/2023) describe a 1-month allowance for all supplies and accessories for CGM. The DME MACs do not have the authority from CMS to allow billing of CGM supplies at a greater quantity than monthly.

Many commenters requested the coverage criterion requiring at least one daily administration of insulin be modified to allow for less frequent administrations of insulin which may be FDA approved in the near future (i.e., weekly insulin). These commenters suggested using more general verbiage such as “the beneficiary is treated with any insulin” or “the beneficiary is insulin-treated.”

After review of the available evidence, the DME MACs agree and have modified the coverage criterion in the final Glucose Monitors LCD to state: “The beneficiary is insulin-treated.” 

Several commenters requested clarification of the coverage criterion requiring at least one daily administration of insulin to ensure individuals utilizing an insulin infusion pump would qualify for coverage.  

The DME MACs were not intending to exclude insulin infusion pump users from coverage and have modified the wording in the final Glucose Monitors LCD criterion as follows: “The beneficiary is insulin-treated.” 

Two commenters indicated they were supportive of the allowance of a CGM for individuals with diabetes and a history of hypoglycemia but would like clarification on what documentation would be required to support the coverage criterion is met. The commenters expressed concerns about the ability to obtain medical records with specific numerical values of the glycemic events. 

There are two pathways to coverage for beneficiaries with diabetes and a history of problematic hypoglycemia:

Pathway one allows coverage for non-insulin treated beneficiaries with diabetes with recurrent level 2 hypoglycemic events (glucose <54mg/dL (3.0mmol/L) that persist after 2 or more attempts to adjust medication(s) and/or modify the diabetes treatment plan. The treating practitioner may document any of the following: the actual glucose value; classification of the hypoglycemic episode as a level 2 event; or incorporation of a copy of the beneficiary’s BGM testing log into the medical record. Additionally, the medical record must notate at least two previous medication adjustments or modifications to the treatment plan (such as raising A1c targets) prior to the most recent level two event.

Pathway two allows for coverage for non-insulin treated beneficiaries with diabetes who have experienced one level 3 hypoglycemic event (glucose <54mg/dL (3.0mmol/L) which is characterized by altered mental and/or physical state that requires third-party assistance for treatment. The treating practitioner may document any of the following: the actual glucose value; classification of the hypoglycemic episode as a level 3 event; or incorporation of a copy of the beneficiary’s BGM testing log into the medical record. Additionally, the medical record must include a notation that the beneficiary required third party assistance for treatment.

A few commenters requested coverage of CGM for beneficiaries without diabetes, but with other rare causes of hypoglycemia such as bariatric surgery or pancreatectomy. Some of these commenters questioned the applicability of the Home Blood Glucose Monitors National Coverage Determination (NCD) 40.2 to CGMs since it was developed prior to CGMs entering the market and describes BGM in detail. 

CMS Final Rule (CMS-1738-F) classified adjunctive/non-adjunctive CGMs as durable medical equipment used in making diabetes treatment decisions. The final rule does not address use of CGMs for Medicare beneficiaries without diabetes. CMS-1738-F states (in relevant part): “Because certain CGMs have been approved or cleared by the FDA to replace blood glucose monitors for use in making diabetes treatment decisions [emphasis added], we believe that CGMs represent a newer technology version of glucose monitors paid for by Medicare in 1986 and 1987.”

A few commenters requested CGM supplies be allowed for beneficiaries who exclusively utilize a smart device to review their CGM values.  

CGM devices are covered under the durable medical equipment benefit. As noted in the CMS Benefit Policy Manual (Pub. 100-02), Chapter 15, Section 110.3, “Payment may be made for supplies, e.g., oxygen, that are necessary for the effective use of durable medical equipment.” Smart devices do not meet the definition of DME; therefore, in the event CGM supplies are used exclusively with a non-DME device (watch, smartphone, tablet, etc.) they will be denied as non-covered.

One commenter requested coverage of a back-up BGM in the event of CGM failure or dysfunction. 

The supply allowance for non-adjunctive CGMs includes the cost of a BGM and testing supplies. A BGM and testing supplies are separately payable in addition to an adjunctive CGM. 

One commenter noted their appreciation for the recognition of the racial, income, and geographic disparities that exist within the diabetes community and access to CGM. 

The DME MAC Medical Directors thank the commenter for their feedback and are hopeful that the finalized LCD will help decrease health disparities in the diabetes community.  

Several commenters noted that the proposed Glucose Monitors LCD may improve access to CGMs which in turn could advance equity and reduce health disparities. 

The DME MACs are sensitive to these concerns and appreciate the recognition that the finalized policy may help decrease health disparities by improving access to CGMs.

One commenter requested the same coverage criteria be implemented by the A/B MACs for implantable CGMs. 

This comment is outside the scope of the current LCD reconsideration requests and proposed changes to the LCD. The commenter may submit a reconsideration request to the appropriate A/B MACs for consideration.  

One commenter requested a minimum of 60 days to implement the final LCD to ensure required coding changes are in place. 

In an effort to finalize the Glucose Monitors LCD prior to the end of the Public Health Emergency (PHE), the DME MACs are providing the minimum 45 calendar day notice as required by the CMS Program Integrity Manual (Pub. 100-08), Chapter 13, Section 13.2.6. 

One commenter submitted additional literature to support the proposed LCD without comments. 

The DME MAC Medical Directors thank the commenter for the additional literature. It has been reviewed for relevancy and inclusion in the final Glucose Monitors LCD, as appropriate. 

Many commenters requested the DME MACs work expeditiously to finalize the proposed Glucose Monitors LCD prior to the end of the PHE. The commenters wanted to ensure coverage remain in place for beneficiaries who received a CGM due to temporary PHE waivers. 

The DME MACs are receptive to the concerns of the stakeholders and have worked expeditiously to finalize the Glucose Monitors LCD. 

One commenter urged the DME MACs to include a specific provision in the LCD which would allow continued CGM access to any beneficiaries that qualified during the PHE. 

The DME MACs are awaiting clarification from CMS on how to address ongoing claims for beneficiaries who received CGM coverage during the PHE.