In October 2017, Parrish Law Offices won a District Court case where the Court found that Medicare’s denial of a CGM was arbitrary and capricious and not supported by substantial evidence. See Whitcomb v. Burwell, No. 2:17-CV-14 (E.D. Wis. Oct. 26, 2017) The Medicare Appeals Council/Secretary had argued that a CGM is simply precautionary because individuals should conduct a confirmatory finger stick before adjusting insulin based on CGM values. The Court rejected that argument and 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.
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 did not appeal that decision and it is final.
On January 30, 2018 the District Court in Vermont also found that “no evidence supports the . . . conclusion that a CGM is not ‘primarily and customarily used to serve a medical purpose.’” Bloom v. Azar, 5:16-cv-121 (Vt. Jan. 30, 2018). The Court specifically acknowledged that the Medicare beneficiary continued to conduct finger stick testing, but found that a CGM performs a function that fingersticks do not, and that “a technology’s purpose is not altered just because it must be calibrated or confirmed by another technology.” The Court ordered Medicare to cover the CGM for the Medicare beneficiary.
Judge Crawford is the fourth District Court judge to reject the Secretary’s assertion that CGM is simply precautionary. The Secretary has 60 days to file an appeal to the Circuit Court.
This case, however, also underscores the challenges Medicare beneficiaries face through the Medicare appeals process. The Plaintiff in each of the cases that has reached District Court endured five levels of appeal and often filed multiple appeals. Dr. Bloom had reached the Administrative Law Judge level 13 times and presented his case to 13 different Administrative Law Judges. He began receiving favorable Administrative Law Judge decisions as far back as 2011 but was forced into the appeal process each time a claim for CGM supplies was denied.
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.
The access problem continues to be 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. Many individuals believe they are being forced to choose between Medicare coverage and access to individuals who can provide care including an intervention, if they experience a hypo/hyperglycemic event. 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 telehealth 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, contact:
admin@dparrishlaw.com or
Debbie Parrish
412-561-6250
788 Washington Road
Pittsburgh, PA 15228