Minnesota law [Minn. Stat. § 151.47(f)] requires wholesale drug distributors and manufacturers to report annually to the Minnesota Board of Pharmacy (Board) all "payments, honoraria, reimbursement or other compensation" permitted under the gift prohibition statute and provided to practitioners during the previous calendar year. The annual disclosure report is due by May 1st of each year for expenditures incurred during the preceding calendar year.
On January 8, 2013, the Board indicated in a letter that it will not require wholesale drug distributors and manufacturers to submit annual disclosure reports for the 2012 calendar year. The Board’s letter notes that the Sunshine Act provisions of the federal Patient Protection and Affordable Care Act (Sunshine Act) preempts state laws that require manufacturers to report the same information required by the federal law. Since the Board requires wholesale drug distributors and manufacturers to report most of the information required by the Sunshine Act, the Board will not require these entities to report data for the 2012 calendar year.
Additionally, the Board indicated that it will ask the Minnesota Legislature to repeal § 151.47 of the law. The Board will not ask the Legislature, however, to repeal the gift ban, which prohibits wholesale drug distributors and manufacturers from offering or giving any gift to a practitioner in excess of $50 per calendar year.
The federal Office of Management and Budget (OMB) has received final regulations from the Centers for Medicare and Medicaid Services (CMS), which would implement the Sunshine Act. CMS previously missed the October 1, 2011, deadline to establish regulations implementing the Sunshine Act. 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 or investment interests held by physicians or members of their family. Although the Sunshine Act requires manufacturers and GPOs to begin collecting data starting January 1, 2012, CMS has previously indicated that it will not require data collection by applicable manufacturers and applicable GPOs before January 1, 2013.