Wisconsin District Court Rules the Secretary Cannot Use an Article to Deny Coverage for CGM

On May 26, 2015, the District Court for the Eastern District of Wisconsin ruled that the Secretary of Health and Human Services cannot deny coverage of a continuous glucose monitor based on a statement in an Article that such monitors are “precautionary.” The case reflects the arduous path that Type 1 diabetic Medicare beneficiaries endure while trying to secure coverage for a medical device that is considered the standard of care for Type 1 diabetics with hypoglycemic unawareness – a device widely deemed necessary to prevent life-threatening hypoglycemic events. The Medicare beneficiary had sought coverage from United Healthcare’s Secure Horizon’s Medicare Advantage Plan. Although United Healthcare covers CGM on a limited basis for non-Medicare beneficiaries, it does not cover CGM for Medicare beneficiaries.

Through every phase of the multi-step Medicare administrative appeals process, the Plaintiff appealed the denial of a CGM that she got in April 2011. Although statutory regulations provide that an administrative law judge should issue a decision within 90 days of a request for an administrative hearing, 231 days passed until the Plaintiff received a favorable administrative law judge decision, i.e., February 2013. United Healthcare appealed the favorable decision and the Medicare Appeals Council reversed the decision asserting that the Medicare contractor’s local coverage determination (“LCD”) incorporated a Medicare Article that deemed CGM to be “precautionary.” Although Medicare regulations require the Council to issue a decision within 90 days of a request for review, the Council took approximately six months to render a decision, i.e., August 2013.

The District Court, however, found that the LCD did not incorporate the Article by reference nor vise versa. Further, the Court noted the distinction between LCDs (which indicate whether a device is reasonable and necessary) and Articles (which address non-coverage information such as coding and payment). The Court reasoned that if a Medicare contractor could issue a coverage decision in an Article, it would subvert the LCD development process and would undermine Medicare beneficiaries’ ability to challenge a non-coverage policy as envisioned by Congress under Section 522 of BIPA.

The Court remanded the matter to the Medicare Appeals Council to determine the Medicare beneficiary’s need for CGM based on her individual medical condition, i.e., without reference to the Article. The case underscores the challenges faced by Medicare beneficiaries seeking coverage of a device that is the standard of care, and the Office of Medicare Hearings and Appeals’ and Council’s failure to meet statutory deadlines, even for Medicare beneficiaries.

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