OAR 410-122-0730: Continuous Glucose Monitoring Equipment and Supplies

(1) Indications and Limitations of Coverage and Medical Appropriateness: (a) The Division shall cover personal, real-time continuous glucose monitoring (CGM) equipment and supplies for clients with a diagnosis of type 1 diabetes mellitus, type 2 diabetes mellitus, or gestational diabetes when criteria in the Prioritized List of Health Services Continuous Glucose Monitoring Guideline Note are met; (b) Continuous glucose monitoring equipment and supplies (E2102, E2103, A4238, A4239, A9276, A9277, A9278) require prior authorization (PA) with clinical documentation to support that all criteria in OAR Ch. 410 Div. 122 DMEPOS rules and Table 122-0730 are met; (c) Initial authorization shall be limited to six (6) months from the date of Division’s authorization. Continued use beyond the initial six (6) months authorization requires the provider send to the Division current medical documentation of a client follow up visit with the treating practitioner which supports that there continues to be a medical need, that the requirements of this rule are met, and the client is regularly utilizing the CGM and the data from the CGM to adjust insulin; regularly utilizing means that the client used the device for at least 50 percent of the time since the date of the initial authorization; (d) CGM equipment must be FDA approved for the age of the client; (e) Insulin pumps with integrated CGM function require prior authorization and must meet criteria in this rule and OAR 410-122-0525; (f) The Division considers all other applications of real-time CGM to be investigational as the effectiveness of its use has not been established in peer-reviewed professional literature; (2) Therapeutic/Non-adjunctive CGM devices (E2103 and A4239) are used to make treatment decisions and replaces standard blood glucose monitoring and related supplies. Standard blood glucose monitoring and supplies (E0607, E2100. E2101, A4233, A4234, A4236, A4244. A4245, A4246, A4247, A4250, A4253. A4255. A4257, A4258, A4259) cannot be billed separately to the Division on any day that falls within the CGM authorization time period when the client is using non-adjunctive CGM. This is a duplication of services; (3) Non-therapeutic/Adjunctive CGM devices (E2102 and A4238) do not replace standard blood glucose monitoring. These supplies may be billed separately; (4) PA requests for CGM systems that are FDA approved but are not considered DME (i.e., CGM systems that use smart phone exclusively for monitor/receiver) will be reviewed on a case-by-case basis. Clinical documentation from the treating practitioner, specific to the client, must demonstrate that all other covered CGM alternatives have been considered, tried and failed, or reasonably expected to fail; (5) Providers may not use A9276, A9277, or A9278 to bill supplies for any CGM device coded as an adjunctive CGM (E2102) or non-adjunctive CGM (E2103) device. Providers shall refer to the product classification list on the Pricing, Data Analysis and Coding (PDAC) contractor website for coding verification; (6) Reasonable useful lifetime (RUL) of CGM is no less than three (3) years; (a) Computation of the useful lifetime is based on when the CGM is delivered to the client, not the age of the device; (b) If there is a medical need to replace a CGM device within the RUL period, the provider must submit documentation to corroborate the malfunction of the CGM and records to support the individual’s medical necessity and appropriateness for the new device and ongoing treatment for a case-by-case review. (7) Documentation: (a) For PA, submit documentation that supports coverage criteria and guidelines in this rule are met; (b) Medical records and documentation to support the client meets criteria and conditions of coverage in this rule must be kept on file with the durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) provider and shall be made available to the Division upon request. (8) See Table 122-0730 for billing codes. [ED. NOTE: To view attachments referenced in rule text, click here to view rule.]