Response To Comments Article

Response to Comments: Glucose Monitors – DL33822

A58798

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A58798

Article Title
Response to Comments: Glucose Monitors – DL33822

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Response to Comments

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During the 45-day comment period, which was open from 12/17/2020 through 01/30/2021, the DME MACs received a total of 26 comments* from 47 commenters.

*This count refers to the total comments/submissions received on this proposed local coverage determination as of January 30, 2021. Note: The MACs review all submitted comments; however, MACs may choose to consolidate similar thematic comments, redact or withhold certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language or duplicate/near duplicate submissions from a mass-mailing campaign. This can result in discrepancies between this count and the number of responses to comments.

Introduction to Responses

The DME MACs appreciate the comments received from stakeholders during the open comment period on the proposed Glucose Monitors Local Coverage Determination (LCD).

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13:

In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines.

Accordingly, the final policy and our response to comments are based on the best currently available published clinical evidence, to support: (1) removal of the coverage criteria requiring beneficiary use of a blood glucose monitor (BGM) and performing frequent (four or more times a day) testing in order to qualify for a continuous glucose monitor (CGM); and, (2) a change in CGM coverage criteria to allow qualification of individuals using multiple daily administrations of any insulin (including inhaled insulin, Afrezza).

Response To Comments

Number	Comment	Response
1	Many commenters indicated their support for removal of the coverage criteria requiring beneficiary use of a BGM and performing frequent (four or more times a day) testing in order to qualify for a CGM.	The DME MAC Medical Directors would like to thank the beneficiaries, suppliers, physicians, manufacturers, associations, and others for taking the time to submit detailed comments and support for the proposed changes to the Glucose Monitors LCD. The policy will be finalized as proposed with the removal of the requirement for frequent testing of ≥4 times per day on a BGM to qualify for a CGM.
2	Many commenters indicated their support for the change in CGM coverage criteria to allow qualification of individuals using multiple daily administrations of any insulin (including inhaled insulin, Afrezza).	The DME MAC Medical Directors would like to thank the beneficiaries, suppliers, physicians, manufacturers, associations, and others for taking the time to submit detailed comments and support for the proposed changes to the Glucose Monitors LCD. The policy will be finalized as proposed and allow for multiple daily administrations of any insulin in order to qualify for CGM.
3	One commenter requested Medicare coverage of Afrezza.	Coverage and reimbursement of Afrezza is not under the jurisdiction of the DME MACs, but may be available through other parts of the Medicare program. The proposed change to the DME MAC LCD is to allow the use of Afrezza as an alternative to injected insulin as a pathway to coverage of a CGM device.
4	Several commenters requested that inhaled insulin, Afrezza, be added to the CMS’s Part D Senior Savings Model.	This comment is outside the scope of the LCD reconsideration and should be directed to CMS. Additional information on CMS’s Part D Senior Savings Model is available at: https://innovation.cms.gov/innovation-models/part-d-savings-model.
5	Several commenters requested the removal of the CGM coverage criterion requiring the “beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a Medicare-covered continuous subcutaneous insulin infusion (CSII) pump.”	The DME MAC Medical Directors thank the commenters for the feedback and are sensitive to these concerns; however, this comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
6	Several commenters indicated that excluding patients that use insulin <3 times per day from CGM coverage adds to the existing disparities in medicine and affects minorities and those with fewer resources disproportionately.	The DME MAC Medical Directors thank the commenters for the feedback and we share your concerns related to how medical policies can disproportionately affect minorities and those with fewer resources. However, this comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
7	Several commenters requested the removal of the CGM coverage criterion requiring “frequent adjustment by the beneficiary on the basis of BGM or CGM testing results.”	The DME MAC Medical Directors thank the commenters for the feedback. This criterion is intended to ensure that beneficiaries are using CGM readings to actively guide their diabetes therapy. It is not a mandate that insulin dose adjustments must be made if glucose levels are within the target range as established collaboratively with their treating practitioner. The Policy Specific Documentation Requirements section in the LCD-related policy article has been updated to clarify the intent of this criterion.
8	Several commenters suggested removing the words “Medicare-covered” from the coverage criterion that requires “the beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a Medicare-covered continuous subcutaneous insulin infusion (CSII) pump” to allow coverage for beneficiaries using disposable pumps not covered under the DME MAC policy.	The DME MAC Medical Directors agree and the LCD will be finalized with the following language: “The beneficiary is insulin-treated with multiple (three or more) daily administrations of insulin or a continuous subcutaneous insulin infusion (CSII) pump; and,”
9	Several commenters suggested modifying the coverage criteria to allow telehealth visits to meet the requirements for the initial and follow-up in-person visits.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
10	One commenter suggested modifying the coverage criteria for beneficiaries entering Medicare to only require a “New to Medicare” welcome visit and not require recertification once Medicare eligible.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD. Documentation requirements for equipment retained from another payer are available in the Standard Documentation Requirements for All Claims Submitted to DME MACs Policy Article (A55426). The policy article includes the following (in relevant part and emphasis added): “When a beneficiary receiving a DMEPOS item from another payer (including a Medicare Advantage plan) becomes eligible for the Medicare Fee For Service (FFS) program, the first Medicare claim for that item or service is considered a new initial Medicare claim. Medicare does not automatically continue coverage for any item obtained from another payer when a beneficiary transitions to Medicare coverage. For Medicare to provide payment, the beneficiary must meet all Medicare coverage, coding, and documentation requirements for the DMEPOS items in effect on the DOS of the initial Medicare claim.”
11	Several commenters suggested modifying the coverage criteria to allow a yearly face to face visit to assess adherence instead of every 6 months.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
12	One commenter requested the External Infusion Pumps (L33794) and Glucose Monitors (L33822) policies be aligned to require reassessment visits at the same time intervals for CGM and insulin infusion pumps.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
13	One commenter indicated the DME MACs should not require monthly reassessment of CGM usage.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
14	One commenter indicated that use of other sulfonylureas should qualify a beneficiary for CGM.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
15	Several commenters requested coverage of CGM for individuals with chronic kidney disease without diabetes mellitus.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD. National Coverage Determination (NCD) 40.2 limits coverage of home blood glucose monitors to beneficiaries with diabetes. Additional information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess
16	One commenter, with the support of many other clinicians and beneficiaries via a signed petition, requested coverage of CGM for hypoglycemic beneficiaries without diabetes.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD. National Coverage Determination (NCD) 40.2 limits coverage of home blood glucose monitors to beneficiaries with diabetes. Additional information on the NCD reconsideration process is available here: https://www.cms.gov/Medicare/Coverage/DeterminationProcess
17	One commenter requested coverage of CGM for individuals with physical disabilities preventing them from testing 4x/day with a BGM.	The DME MAC Medical Directors thank the commenter for the feedback and we share your concerns that beneficiaries with physical disabilities may not be able to use a standard blood glucose monitor. The requirement that a beneficiary has been using a BGM and performing frequent (four or more times a day) testing of their blood sugar has been removed from the current LCD, as reflected in the criteria for a CGM device in the proposed LCD.
18	Several commenters submitted their own proposed coverage criteria for consideration.	The DME MAC Medical Directors appreciate the comments and suggestions for additional changes to the CGM criteria; however, requests for changes to criteria beyond what was proposed are outside the scope of the current requests and will require a new reconsideration.
19	One commenter indicated that the only coverage criterion for a CGM should be a diagnosis of diabetes mellitus.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
20	One commenter provided a general comment on the need for broader approval of CGMs to help get the hyperglycemia epidemic under control.	The finalized changes to the LCD are relaxing the coverage criteria for CGMs and will therefore allow for broader approval of CGMs.
21	One commenter requested that the policy provide guidance on beneficiaries needing to return to BGM after unsuccessful CGM use.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
22	Several commenters requested the simplification of CGM documentation requirements and suggested consultation with the supplier community on the proposed changes.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
23	Several commenters submitted questions or comments regarding the CMS proposed rule CMS-1738-P and requested the policy be updated with this revision to incorporate the proposed changes.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD. The DME MACs are not able to make any policy changes based on proposed rules.
24	One commenter indicated that the DME MACs should not require glucose logs be submitted every 30 days.	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD. Additionally, the current LCD does not require monthly submission of glucose logs.
25	One commenter requested a pathway to coverage for all 3 components of an interoperable closed-loop system (the CGM, insulin pump, and software).	This comment is outside the scope of the current LCD reconsideration requests and the proposed changes to the LCD.
26	One commenter requested a technical correction in the Summary of Evidence background section to the frequency range in which CGMs measure interstitial fluid glucose levels.	The suggested change was reviewed and is reflected in the final LCD. This minor technical change does not affect the level of evidence evaluation or the conclusion.

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