With only 9 weeks until 2012, pharmaceutical and medical device manufacturers are still waiting for federal regulations to provide guidance for the implementation of the Federal Sunshine Act.

Senators Grassley and Kohl have already sent a memorandum directly to CMS requesting an immediate explanation on missing the deadline, but no response was received. There is now a growing concern among parties in the industry and more are speaking out.

On October 25, 2011, a letter was sent to Secretary Kathleen Sebelius of HHS from Advanced Medical Technology Association (AdvaMed), Biotechnology Industry Organization (BIO), Community Catalyst (CC), Consumers Union (CU), Medical Imaging & Technology Alliance (MITA), Pew Health Group (PHG) and Pharmaceutical Research and Manufacturers of America (PhRMA).

"Many companies have already invested significant resources in preparing to comply with the Sunshine provision," they state, "…An absence of established procedures could harm both the companies who are trying to comply with the law and the public who stands to benefit from increased transparency of these relationships."

The MediSpend Team will continue to monitor and send any updates as they become available. To receive the Legislative Watch Alerts via email, go to the MediSpend Blog and sign-up.