By Leah S. Poniatowski, J.D.
Administrative ruling excluding Medicare coverage for device overruled because monitor fell within scope of regulation.
A Medicare beneficiary with Type I diabetes and a kidney transplant successfully challenged an administrative ruling that excluded coverage for a continuous glucose monitor that he used in conjunction with his blood glucose monitor after a federal district court determined that the administrative ruling was not supported by the evidence (Olsen v. Cochran, February 23, 2021, Mendoza, S.).
The Medicare beneficiary with Type I diabetes had experienced kidney failure and received a transplant. His doctor prescribed a Medtronic MiniMed™Continuous Glucose Monitor (CGM) to prevent his body from rejecting the transplant and to prevent diabetes-related complications, especially because—according to the beneficiary—he suffers from hypoglycemic unawareness.
The beneficiary sought Medicare coverage for the device, and his claim initially was denied for not being "durable medical equipment," but an administrative law judge (ALJ) later approved the claim. However, the Medicare Appeals Council/Departmental Review Board (Appeals Council) entered a ruling, reversing the ALJ on the ground that the CGM was not “primarily and customarily used to serve a medical purpose" and, therefore, not "durable medical equipment." The beneficiary filed the present multi-count civil lawsuit.
Legal definition. The district court observed that the case at bar relied upon 42 U.S.C. § 1395x(s)(6), which provides the statutory definition of “durable medical equipment," and includes “blood-testing strips and blood glucose monitors for individuals with diabetes without regard to whether the individual has Type I or Type II diabetes or to the individual’s use of insulin (as determined under standards established by the Secretary in consultation with the appropriate organizations)."
Moreover, under the applicable regulation, devices that meet five requirements can be included in the non-exhaustive statutory definition. Thus, per 42 C.F.R. § 414.202, a device can qualify if it: (1) “[c]an withstand repeated use"; (2) “has an expected life of at least 3 years"; (3) “[i]s primarily and customarily used to serve a medical purpose"; (4) “[g]enerally is not useful to an individual in the absence of an illness or injury"; and (5) “[i]s appropriate for use in the home."
Coverage precedent. The district court applied the abuse of discretion standard of review in the case at bar. The Appeals Council based its ruling on CMS-1682-R, a final opinion and order. Under this ruling, it was held that CGMs are not "durable medical equipment" because the primary function—not the individual’s use—of a device is to be considered and the primary function of the CGM is an "adjunctive device" that "complement[s], not replace[s], information obtained from blood glucose monitors in making diabetes treatment decisions [and] are referred to as ‘non-therapeutic’ CGMs."
The district court held that it did not need to defer to the agency’s interpretation because the underlying regulation was not "genuinely ambiguous." The district court stated that there was no evidence to support construing the regulation to require that a device not serve an "adjunctive" purpose in order to qualify under the regulation’s "primary and customarily used to serve a medical purpose" language. The beneficiary’s device offered him more glycemic control, which was important in light of his kidney transplant and hypoglycemic unawareness. Although the CGM occasionally may need to be calibrated with his blood glucose monitor, the need for calibration does not alter its purpose, according to case precedent. Accordingly, the district court determined that it would "join the district courts who have found that the CGM constitutes durable medical equipment," granting the participant’s motion for summary judgment and reversing the Appeals Council decision.
The case is No. 2:20-cv-00374-SMJ.
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