On January 22, 2013, Senator Charles Grassley, ranking Member of the U.S. Senate Committee on the Judiciary, sent a letter to the Honorable Jacob J. Lew, the White House Chief of Staff, expressing disappointment in the continued delay in implementing the “Sunshine Act” provisions of the Patient Protection and Affordable Care Act. In his letter, Senator Grassley urged the release of final regulations implementing the Sunshine Act “without further delay.” Senator Grassley also noted that the delay in implementation is “disrupting the considerable efforts of the pharmaceutical and medical device manufacturers that are already investing in systems to comply with the law, as well as voluntary efforts of universities and even the National Institutes of Health to promote more transparent relationships between physicians and industry.”
If the final regulations are not going to be released by January 24, 2013, Senator Grassley requests that Mr. Lew “provide a date by which they will be issued and an explanation for the delay.”
On November 27, 2012, the Centers for Medicare and Medicaid Services (CMS) provided the Office of Management and Budget final regulations, which would implement the Sunshine Act provisions. CMS previously missed the October 1, 2011, deadline to establish regulations implementing these provisions. The Sunshine Act requires drug, device, biological product, and medical supply manufacturers to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires manufacturers and group purchasing organizations (GPOs) to report all ownership and investment interests held by physicians or members of their families. Although the Sunshine Act requires manufacturers and GPOs to begin collecting data starting January 1, 2012, CMS previously indicated that it will not require data collection by applicable manufacturers and applicable GPOs before January 1, 2013.