Eli Lilly, U.S. Centers for Medicare & Medicaid Services, U.S. Department of Health and Human Services diagnostic news

Eli Lilly is helping to finance a lawsuit seeking to overturn a 2013 decision from CMS to only cover beta amyloid imaging in Medicare patients with dementia or neurodegenerative diseases only if the patients are enrolled in a qualifying clinical trial. The suit was filed in the U.S. District Court for the District of Columbia against HHS and CMS by three Medicare beneficiaries with cognitive impairment.

In September 2013, CMS issued a final decision to require coverage with evidence development (CED) for beta amyloid imaging after concluding that there was insufficient evidence it improves health outcomes in patients with dementia or neurodegenerative disease. The plaintiffs are arguing that CMS's decision is inconsistent with the language of Medicare Act because it requires a diagnostic service to change the treatment of a disease to qualify for coverage under a Medicare program. The Medicare Act provides for coverage of items that are "reasonable and necessary for the diagnosis or treatment" -- not reasonable and necessary for both diagnosis and treatment. To qualify for reimbursement, trials must be approved by CMS and test new agents or prognostic or diagnostic tools for patients with Alzheimer's disease or dementia. According to the complaint, no qualifying trial currently exists (see BioCentury, July 15, 2013 & Oct. 7, 2013). ...