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By Abrielle Uritz, RN, BSN, CPC, CEMC - Clinical Consultant As you may remember, previous CMS changes effective January 2017, discussed the use of smart devices like cell phones or tablets to display results of Continuous Glucose Monitors (CGM). The receiver qualifies as the DME and the smart devices do not qualify as DME. CMS originally said if a smart device was used to display the results, even with the receiver, the supplies used would be noncovered. CMS reconsidered this decision and as of early June 2018, Medicare coverage is now available for CGM system, supplies, and accessories if a noncovered smart device is used in conjunction with the CGM receiver. Coverage of CGM system, supplies, and accessories are available for the therapeutic CGM systems where the beneficiary uses a covered receiver classified as DME to display the data. If the beneficiary intends to never use the receiver classified as DME as the display device, supplies and accessories will not be covered by Medicare. Examples:

1. Medicare coverage of CGM supplies and accessories would be available where a patient uses a durable CGM receiver to display their glucose data while simultaneously transmitting the data to a caregiver through a smartphone.
2. Medicare coverage will be available when the patient uses a durable receiver on some days to review glucose data and other days uses a non-DME device (smartphone, tablet).

Prior to December 2016, FDA did not consider a CGM system as accurate enough to be the primary device in making therapy decisions about glucose levels. The FDA changed this for one CGM system in December of 2016, meaning it can be used as the primary device in making therapy decisions. Prior to this, CGM systems were not covered as DME as they were not the primary device in making therapy decisions. On January 12, 2017, CMS reconsidered their coverage and CGMs were covered for beneficiary’s with diabetes requiring frequent testing, frequent dosing of insulin, and frequent adjustment of diet and insulin. Prior to billing claims, check Pricing, Data Analysis and Coding Contractor (PDAC) to determine if the device you are billing is classified as a therapeutic CGM. The PDAC site has an up to date list of therapeutic CGMs. All non-therapeutic CGM systems must be billed using codes A9276, A9277, A9278 which are non-covered by Medicare. Therapeutic CGM receiver must be billed as K0554, and supply items must be billed as K0553 which includes all supplies and accessories and must be billed as 1 unit of service per month. Medicare will not pay for a smart device itself when used in conjunction with the CGM; however, if the supplier chooses to bill Medicare for the smart device they must use A9270. A therapeutic CGM may be covered by Medicare when the beneficiary has diabetes mellitus, has been using a home Blood Glucose Monitor (BGM) and performing frequent (4 or more) BGM testing, the beneficiary is insulin-treated with multiple daily injections of insulin or a continuous subcutaneous insulin infusion pump, and the beneficiary’s insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of therapeutic CGM testing results