Home blood glucose monitors (BGMs) and continuous glucose monitors (CGMs) are covered under the Durable Medical Equipment (DME) benefit. In order for a beneficiary’s DME to be eligible for reimbursement, the reasonable and necessary (R&N) requirements set out in the related Local Coverage Determination (LCD) must be met.
In addition, there are specific statutory payment policy requirements, that also must be met. Information provided in this article relates to determinations other than those based on Social Security Act §1862(a)(1)(A) provisions (i.e., “reasonable and necessary”). For any item to be covered by Medicare, it must
- be eligible for a defined Medicare benefit category,
- be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member, and
- meet all other applicable Medicare statutory and regulatory requirements.
On or after January 12, 2017, Medicare began coverage of therapeutic CGM devices under the DME benefit. CGM devices covered by Medicare were defined in CMS Ruling 1682R as therapeutic CGMs. A therapeutic or non-adjunctive CGM can be used to make treatment decisions without the need for a stand-alone BGM to confirm testing results. A non-therapeutic or adjunctive CGM requires the user to verify their glucose levels or trends displayed on a CGM with a BGM prior to making treatment decisions.
On February 28, 2022, CMS determined that both therapeutic/non-adjunctive and non-therapeutic/adjunctive CGMs may be classified as DME. CGM devices that solely display results on a smartphone and do not have a stand-alone receiver or integration into an insulin infusion pump do not meet the definition of DME and will be denied as non-covered (no benefit).
The supply allowance for supplies used with a CGM system (K0553, A4238) encompasses all items necessary for the use of the device and includes but is not limited to, CGM sensors and transmitters. For non-adjunctive CGMs, the supply allowance (K0553) also includes a home BGM and related supplies (test strips, lancets, lancing device, calibration solution, and batteries), if necessary.
Supplies or accessories billed separately will be denied as unbundling. For adjunctive CGMs, the supply allowance (A4238) encompasses all items necessary for the use of the device and includes but is not limited to, CGM sensors and transmitters.
Applicable Modifiers
For blood glucose monitors (codes E0607, E2100, E2101) and related supplies (codes A4233, A4234, A4235, A4236, A4244, A4245, A4246, A4247, A4250, A4253, A4255, A4256, A4257, A4258, A4259) and CGM devices (code K0554 or E2102) and supply allowance (code K0553 or A4238), the following modifiers must be added to the code(s) on every claim submitted:
- Use modifier KX if the beneficiary is insulin-treated; or,
- Use modifier KS if the beneficiary is non-insulin treated
- CG modifier must be added to the claim, only if all of the CGM coverage criteria in the Glucose Monitor LCD are met
- CGMs (K0554 and E2102) and related supplies (A4238 and K0553) which are classified by the Food & Drug Administration as Class III devices must include the KF modifier.
Medical Billers and Coders (MBC) is a leading medical billing company providing complete revenue cycle services. We shared Medicare reasonable and necessary (R&N) requirements for glucose monitors for reference purposes only, our article doesn’t guarantee any payment.
We can assist you in Medicare billing and coding for your practice. To know more about our billing and coding services, contact us at info@medicalbillersandcoders.com/ 888-357-3226
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Reference: Glucose Monitor – Policy Article
FAQs
1. What is required for Medicare coverage of blood glucose monitors (BGMs) and continuous glucose monitors (CGMs)?
To be covered, BGMs and CGMs must meet Medicare’s “reasonable and necessary” requirements and comply with local coverage determinations (LCDs).
2. What is the difference between therapeutic and non-therapeutic CGMs?
Therapeutic CGMs can make treatment decisions without a separate BGM, while non-therapeutic CGMs require a BGM to verify results before treatment.
3. Can CGMs that only display results on a smartphone be covered by Medicare?
No, CGMs that display results solely on a smartphone without a stand-alone receiver or insulin pump integration are not covered by Medicare.
4. What does the supply allowance for CGMs cover?
The supply allowance covers all necessary items for using the CGM, including sensors, transmitters, test strips, and related accessories.
5. Which modifiers are required for CGM claims?
Use modifier KX for insulin-treated beneficiaries, KS for non-insulin-treated beneficiaries, and CG for meeting all CGM coverage criteria, with KF for Class III devices.
