Retired - Continuous Glucose Monitors - Frequently Asked Questions

Joint DME MAC Article

1. What is the effective date for coverage of continuous glucose monitors?
   Response: Coverage of therapeutic continuous glucose monitors (CGM), as defined in the CMS Ruling 1682R, is effective for claims with dates of service (DOS) on or after January 12, 2017. Continuous glucose monitors classified as non-therapeutic CGMs remain non-covered (No Medicare benefit).
2. When will the Glucose Monitors LCD and related Policy Article be updated to include CGM coverage?
   Response: The Glucose Monitors LCD and related Policy Article will be updated shortly to reflect the coverage, coding and documentation requirements for therapeutic CGM devices.
3. Are claims for therapeutic CGMs and the related supply allowance currently accepted and processed by the DME MACs? If so, what rules for coverage should a supplier follow until the Glucose Monitor LCD and related Policy Article are published?
   Response: Yes, claims for therapeutic CGMs and the related supply allowance are being accepted and processed by the DME MACs. Suppliers should refer to the following articles for additional information on the coverage, coding and documentation requirements for CGM devices and the supply allowance:

   Coding and Coverage – Therapeutic Continuous Glucose Monitors (CGM) (Published March 23, 2017)

   Billing Instructions – Continuous Glucose Monitors (Published April 20, 2017)

4. Suppliers are currently required to bill the therapeutic CGM and the related supply allowance using miscellaneous codes E1399 and A9999. CMS recently published new HCPCS codes for therapeutic CGM and the related supply allowance. When can suppliers use these new codes?
   Response: These two new codes have a future effective date for claims with dates of service on or after July 1, 2017. The new codes are:

   K0553 - SUPPLY ALLOWANCE FOR THERAPEUTIC CONTINUOUS GLUCOSE MONITOR (CGM), INCLUDES ALL SUPPLIES AND ACCESSORIES, 1 MONTH SUPPLY = 1 UNIT OF SERVICE

   K0554 - RECEIVER (MONITOR), DEDICATED, FOR USE WITH THERAPEUTIC CONTINUOUS GLUCOSE MONITOR SYSTEM

5. What is included in the supply allowance code A9999 (K0553 for DOS on or after July 1, 2017)?
   Response: As noted in the March 23, 2017 DME MAC joint publication titled Coverage and Coding – Therapeutic Continuous Glucose Monitors, the supply allowance for supplies used with a therapeutic CGM system encompasses all items necessary for the use of the device and includes, but is not limited to:& CGM sensor, CGM transmitter, home blood glucose monitor and related blood glucose monitor (BGM) supplies (test strips, lancets, lancing device, and calibration solutions) and batteries.
6. Do the supply allowance codes (A9999/K0553) require a date span?
   Response: No. One unit of service (UOS) of the A9999 supply allowance (K0553 for dates of service on or after July 1, 2017) is for a monthly supply. Suppliers may only bill one (1) UOS at a time.
7. May suppliers bill multiple months of the supply allowance at a time?
   Response: No, only one (1) UOS of the supply allowance may be billed at a time. Suppliers must deliver a sufficient quantity of all necessary supplies to last for an entire month to correctly bill for the CGM monthly supply allowance. A supplier does not have to deliver supplies used with a therapeutic CGM every month to bill code A9999/K0553 every month. To bill for supplies, the supplier must have previously delivered quantities of supplies that are expected to be sufficient to last for one full month following the DOS on the claim. Suppliers must monitor usage of supplies. Billing may continue monthly if sufficient supplies remain to last for one full month as previously described. If there are insufficient supplies to be able to last for a full month, additional supplies must be provided before the supply allowance is billed.
8. May beneficiaries who were previously testing frequently with a blood glucose monitor and who elect to change to a therapeutic CGM continue to receive separate reimbursement for glucose monitor test strips?
   Response: No. For beneficiaries who qualify for reimbursement of a therapeutic CGM, all supplies, including a BGM and all related BGM supplies, are included in the monthly supply allowance payment. Thus, separate billing of a BGM and/or related BGM supplies is considered unbundling.
9. If a patient tells us they are using their smart phone as a receiver, can we use an ABN and inform the patient that the system is not medically necessary?
   Response: As noted in the March 23, 2017 article:
   "Coverage of the CGM system supply allowance is limited to those therapeutic CGM systems where the beneficiary ONLY uses a receiver classified as DME to display glucose data. If a beneficiary uses a non-DME device (smart phone, tablet, etc.) as the display device, either separately or in combination with a receiver classified as DME, the supply allowance is non-covered by Medicare."
   A smart device is not covered under the DME benefit. Supplies used with non-DME items are not covered because the base item is not covered. You may use a voluntary ABN to inform the beneficiary that the claims will be denied as non-covered. Non-covered denials receive a “patient responsibility” (PR) denial with or without an ABN.
10. Are the same modifiers used to bill CGMs and the related supply allowance, like those used for billing blood glucose monitors and related supplies?
    Response:  As noted in the April 2017 DME MAC joint publication titled Billing Instructions – Continuous Glucose Monitors, certain modifiers are required when billing therapeutic CGMs (E1399/K0554) and their related supply allowance (A9999/K0553):

    Use modifier KX if the beneficiary is insulin treated; or,

    Use modifier KS if the beneficiary is non-insulin treated;

    Use modifier CG if all the coverage requirements are met.

11. What HCPCS codes should be used to bill for therapeutic CGMs and the supply allowance?
    Response: The proper code to use depending on the DOS for the claim:

    Dates of Service prior to July 1, 2017:

    Therapeutic CGM - E1399

    Supply Allowance - A9999

    Dates of Service on or after July 1, 2017:

    Therapeutic CGM – K0554

    Supply Allowance – K0555

Refer to the March 23, 2017 DME MAC joint publication entitled Coverage and Coding – Therapeutic Continuous Glucose Monitors for instructions on how to annotate therapeutic CGMs and related supply allowance claims when using a "not otherwise classified" (NOC) HCPCS code.