In August 2011, the United States District Court for the Southern District of Florida granted summary judgment for Advanced Diabetes Treatment Centers’ and ordered the Centers for Medicare & Medicaid Services (“CMS”) to pay for clinical trial monitoring claims that CMS had denied.
The Court found not only were CMS’ decisions denying coverage not supported by substantial evidence, no evidence supported CMS’ decision and there was overwhelming evidence to the contrary. The Court also denied the government’s request that the case be remanded for rehearing, finding that the issues had been fully developed below.
The case is Advanced Diabetes Treatment Center v. Kathleen Sebelius, Secretary of the United States Department of Health and Human Services. The case involved payment for monitoring during clinical trials for pulsed insulin treatment for diabetes. Although the Florida Medicare Coverage Advisory Committee unanimously found that pulsed insulin treatment was not experimental and investigational, the carrier medical director deemed it to be experimental and listed the treatment on its non-coverage list. At the carrier’s urging, ADTC began clinical trials to further validate pulsed insulin treatment for diabetes and the carrier paid for the monitoring claims for approximately five years.
In 2008, the Florida carrier changed its position and began denying monitoring claims. These denials were appealed up to the District Court and were the subject of this decision. Because the Secretary’s position was so contrary to the evidence, the Court ordered payment of attorney’s fees. Despite the District Court order, First Coast did not pay the claims and ADTC was forced to file a Motion to Enforce Judgment. In 2013, the District Court awarded additional attorneys’ fees based on CMS’ conduct.