In the article, “A holiday present from CMS: Proposed regulations for implementing Sunshine Law”, MassDevice, December 19, 2011, reports that medical device companies and others have received a brief reprieve.
Originally, as of January 1, 2012, pharmaceutical, biotechnology and medical device companies were to begin compiling data on their physician expenditures (to meet the requirements spelled out in the Physician Payments Sunshine Provision of the Patient Protection and Affordable Care Act.) However, CMS announced recently that the agency would not require manufacturers to begin collection of information until after the final regulations are issued sometime later in 2012. As a result, medical manufacturers will not be required to submit a disclosure report for the entire year but for only part of 2012.
(The disclosure report is due on March 31, 2013).
Sunshine LawThe Federal Sunshine Law requires manufacturers of medical devices, drugs, biologics and medical supplies to report payments and other transfers of value made to physicians and teaching hospitals to CMS for subsequent public disclosure. Collection of information was to begin January 1, 2012.
Exception: Market Research
Honoraria and incentives paid to physicians and medical personnel for participation in market research and product usability studies are not required to be reported if the research is “blind”. (The medical device company / manufacturer must not know the name of the physician participating in the research and the physician must not know the name of the medical company conducting the research.)
Since much market research is conducted in a “blind” fashion, these studies can continue to be done without monetary disclosure.
Medical Market Consulting has been conducting blind market research for medical companies for 20 years and this important work will not be hampered by the Sunshine Law.
Contact Medical Market Consulting for more information on market research, product usability testing and new business development.
http://www.massdevice.com/news/medicare-drops-sunshine-law-proposals
