Since 2014, Parrish Law Offices has been representing beneficiaries seeking Medicare coverage for Continuous Glucose Monitors (CGMs). Many Medicare beneficiaries had their claims for CGM coverage denied because Medicare claimed that CGMs were not durable medical equipment (DME). These denials forced many Medicare beneficiaries to either forego this life-saving technology or pay for it themselves while navigating Medicare’s complex, arduous and lengthy appeal process. Rather than take on this burdensome task, many Medicare beneficiaries simply gave up. Those who do choose to appeal face up to five levels of appeal. Further, no matter how many times a beneficiary wins at the Administrative Law Judge level, Medicare contends that it is not bound by those decisions and continues to issue denials. Thus, many beneficiaries have been forced to fight six or more times as they seek coverage. Parrish Law Offices has been pleased to assist a number of Medicare beneficiaries through the process, but, to date, none of the appeals have reached a United States District Court where a final decision was made regarding whether CGMs are DME.
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In January 2017, Parrish Law Offices filed suit in the United States District Court for the Eastern District of Wisconsin on behalf of a beneficiary seeking to reverse Medicare’s determination that a CGM is not covered. On October 26, 2017, Judge David Jones reversed a Medicare Appeals Council decision that asserted that a continuous glucose monitor is not durable medical equipment and thus not covered by Medicare. Judge Jones found the Council’s decision was not supported by substantial evidence and was arbitrary and capricious. The Secretary had argued that a CGM is simply precautionary because individuals should conduct a confirmatory finger stick before adjusting insulin based on CGM values. However, the Court noted that Medicare regulations are clear – a device that is primarily and customarily used for a medical purpose meets the regulatory definition of DME. The Court noted a CGM does not serve a non-medical purpose.
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The Court further found that the Council’s interpretation of Medicare regulations was unreasonable, finding the Council had misinterpreted the clear meaning of the regulatory definition of DME. The Court found that Medicare covers numerous other DME that are used in conjunction with other medical equipment, and no basis exists under Medicare regulations or the Social Security Act to exclude CGM from Medicare coverage. The Secretary conceded that a CGM meets the other statutory and regulatory requirements of DME.
Finally, the Court found that the Council’s denial of a CGM in this case was arbitrary and capricious because it conflicted with numerous other final decisions finding a CGM is covered for specific Medicare beneficiaries. The Secretary had argued that those decisions are not precedential and are fact specific. The Court, however, found that whether a CGM is DME does not vary from Medicare beneficiary to Medicare beneficiary. The Court noted that although the Council had not evaluated whether the Medicare beneficiary needed a CGM, the Administrative Law Judge had undertaken such an analysis and found it was appropriate for her.
Judge Jones is the third District Court judge to find that a Medicare Appeals Council decision denying coverage of a CGM on the basis that it is precautionary is flawed. The Secretary has 30 days to file an appeal to the Circuit Court.
In January 2017, Medicare indicated that it would start covering a CGM that can be used without a confirmatory finger stick (the Dexcom G5). However, because Medicare indicated it would only pay for four sensors a month although five per month are required consistent with the FDA approval of the device, and Medicare will not pay for sufficient test strips to calibrate the CGM, but suppliers are required to provide all supplies necessary for effective use of a device, few suppliers have been willing to supply a CGM to Medicare beneficiaries. There are reports that thousands of Medicare beneficiaries have been unable to secure the CGM Medicare expressly has indicated it will cover.
The access problem has been compounded by Medicare indicating it will not cover a CGM if a Medicare beneficiary uses a cell phone application to enable caregivers and medical providers to see the user’s CGM values in real time. The cell phone application is particularly important for those individuals who live alone or have a visual impairment. Medicare’s decision to deny coverage of a CGM on the basis that a patient uses a cell phone application appears contrary to Medicare’s tele-health movement.
Parrish Law Offices represented the Medicare beneficiary in the successful appeal of the Medicare Appeals Council’s denial of a CGM. For additional information regarding the decision or to inquire about obtaining CGM coverage, please contact:
admin@dparrishlaw.com or Debbie Parrish at 412-561-6250.