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The rules say that plans must pay for a medical service or item if regular Medicare would pay for it in this case.
You can find this rule at 42 Code of Federal Regulations (CFR) Section 422.101.
The rules say that CGM devices covered by Medicare under the DME benefit are defined in CMS Ruling
1682R as therapeutic CGMs. Refer to the Non-Medical Necessity Coverage and Payment Rules in the LCDrelated
Policy Article for additional information. Therapeutic CGMs and related supplies are covered by
Medicare when all of the following coverage criteria (1-6) are met:
1. The beneficiary has diabetes mellitus (Refer to the ICD-10 code list in the LCD-related Policy Article for
applicable diagnoses); and,
2. The beneficiary has been using a BGM and performing frequent (four or more times a day) testing; and,
3. The beneficiary is insulin-treated with multiple (three or more) daily injections of insulin or a Medicarecovered
continuous subcutaneous insulin infusion (CSII) pump; and,
4. The beneficiary's insulin treatment regimen requires frequent adjustment by the beneficiary on the basis of
BGM or CGM testing results; and,
5. Within six (6) months prior to ordering the CGM, the treating practitioner has an in-person visit with the
beneficiary to evaluate their diabetes control and determined that criteria (1-4) above are met; and,
6. Every six (6) months following the initial prescription of the CGM, the treating practitioner has an in-person
visit with the beneficiary to assess adherence to their CGM regimen and diabetes treatment plan.
You can find this rule in Local Coverage Determination (LCD): Glucose Monitors (L33822) - Effective
January 1, 2020.
The rules say that continuous glucose monitors (CGMs) are class III medical devices, and require premarket
approval by the Food and Drug Administration (FDA). For the purpose of this Ruling, all CGMs that are
approved by the FDA for use as adjunctive devices to complement, not replace, information obtained from
blood glucose monitors in making diabetes treatment decisions are referred to as "non-therapeutic" CGMs.
According to the FDA approval letter for the therapeutic CGM: the indications for use of the product have been
expanded to include replacement of blood glucose monitors for diabetes treatment decisions; the device is
indicated as a glucose monitoring system for the management of diabetes in persons age 2 years and older;
interpretation of the results of the device should be based on the glucose trends and several sequential readings
over time; the product also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating
both acute and long-term therapy adjustments; and the device is intended for single patient use and requires a
prescription. The therapeutic CGM must be calibrated twice a day using a blood glucose monitor. Based on
this information, the therapeutic CGM is designed and approved to replace a blood glucose monitor currently
classified as DME under the Medicare program, but the device must be calibrated twice a day using a blood
glucose monitor. You can find this rule in CMS Ruling 1682R.
The rules say that the provider, supplier, or beneficiary, as appropriate, must furnish to the intermediary or
carrier sufficient information to determine whether payment is due and the amount of payment. You can find
this rule at 42 CFR 424.5.
The rules say for Medicare to consider coverage and payment for any item or service, the information
submitted by the supplier or provider must corroborate the documentation in the beneficiary's medical
documentation and confirm that Medicare coverage criteria have been met. You can see this in the Medicare
Program Integrity Manual Chapter 3 3.3.2.1.
If you want to read these Medicare rules, you can go to this website www.medicareappeal.com.
The Plan contract says that the Plan covers items and services in accordance with Medicare rules.