International Rehabilitative Sciences Inc. v. Sebelius

The Department of Health and Human Services, the agency that administers Medicare, denied Medicare coverage for the BIO-1000, a piece of durable medical equipment used to treat osteoarthritis of the knee. In four decisions, the Medicare Appeals Council, which is the highest level of agency adjudication, ruled that the BIO-1000 had not been shown to be “reasonable and necessary” for the treatment at issue. The supplier of the device challenges those decisions as arbitrary, capricious, and not supported by substantial evidence.

Today we join the Fourth Circuit in holding that the Medicare Appeals Council’s coverage denials for the BIO-1000 were not arbitrary, capricious, or unsupported by substantial evidence. See Almy v. Sebelius, 679 F.3d 297, 305 (4th Cir.2012).

We hold that, although various ALJs in other cases had granted coverage for the BIO-1000, those cases were at low levels of the agency adjudication process and thus were not binding on the Medicare Appeals Council. The Medicare Appeals Council adequately explained its reasons for denying coverage here.

Furthermore, the coverage denials were supported by substantial evidence. After reviewing the scientific…