“One of the major changes in the medical device sector is the continuously growing emphasis on home health care through wearable device and remote monitoring devices. Technology now allows patients a much more flexible approach to therapy, one that does not diminish their life styles as previously. A recent research report by Meticulous Research estimates that the global home medical devices market is expected to reach $48.47 billion by 2022 with a CAGR of 7.8% over the period of 2016 to 2022.”
“In Los Angeles, eight defendants were charged for their roles in schemes to defraud Medicare of approximately $66 million. In one case, a doctor is charged with causing almost $23 million in losses to Medicare through his own fraudulent billing and referrals for DME, including over 1000 expensive power wheelchairs and home health services that were not medically necessary and often not provided.”
“HDMA’s 2014-15 Factbook updates member financial, operational performance.
The just-published 2014-15 Factbook, a compilation of HDMA member data as well as relevant industry statistics, gives evidence that full-line wholesalers are running faster—shipping more products each day, while handling a higher daily average of orders. The report also provides a snapshot of what the industry was looking like in 2013 just as the Drug Supply Chain Security Act was passed; presumably, the report from a year from now will show how ready the industry was for the Jan. 1, 2015, deadline coming up for reporting transaction information to customers and FDA, per DSCSA requirements. ”
“Throughout the conference, manufacturers, distributors, and other members of the drug supply chain expressed concern over the current lack of guidance from FDA regarding compliance with federal product tracing laws with only 49 days until the DSCSA is set to begin to take effect.
Dr. Connie Jung, Acting Associate Director for Policy and Communications for the Office of Drug Security, Integrity, and Recalls in FDA’s Center for Drug Evaluation and Research, Office of Compliance, once again spoke at the conference and attempted to address some of their concerns.”