As part of its educational outreach to assist Applicable Manufacturers and Group Purchasing Organizations in their Sunshine Law compliance efforts, the Centers for Medicare & Medicaid Services (CMS) has published a “User Guide for Industry.” The User Guide contains a wealth of information, including guidance from CMS on how to operationalize collecting and reporting data. The User Guide is available here.1
The User Guide provides technical assistance to industry in two main areas. First, the User Guide provided a step-by-step analysis tool for determining whether an entity is an “applicable manufacturer” or an “applicable GPO” for purposes of compliance with the law. Second, the User Guide walks through the three versions of the reporting “templates.” The three versions of the templates, referred to as data submission file specifications by CMS, govern: (1) general payments; (2) research payments; and (3) physician ownership disclosures. The User Guide provided detailed instructions for populating the templates.
While the User Guide does not provide much in the way of new information, it is a helpful technical tool for industry to use as part of Sunshine Law compliance efforts. CMS has promised additional educational tools, which should be made available through the Open Payments website, available here.2
Related News: Minnesota Revises Aggregate Spend Law
On a related note, we wanted to alert readers to a development in the State of Minnesota. Minnesota has a law requiring drug companies to report to the Minnesota Board of Pharmacy certain expenditures involving healthcare practitioners. In January 2013, the Board indicated in an open letter to the drug industry that it was viewing the law to be preempted by the federal Sunshine law and thus would not require reporting of any expenses made in calendar year 2012. The Board also indicated that it was lobbying the state legislature for a repeal of the law.
However, instead of repealing the law, the Minnesota legislature passed a bill that modifies the reporting requirements. Under the new law, manufacturers must submit reports to the Board covering the 2014 calendar year but wholesalers are exempt from reporting. In response to the new law, the Board issued an open letter, available here3 stating that it will not be requiring reports covering the 2012 and 2013 calendar years, but that manufacturers should start tracking applicable expenses effective January 1, 2014.
The letter also addressed preemption. In accordance with federal Sunshine’s preemption provisions, the new Minnesota law will not require manufacturers to report any expense that is reportable under Sunshine; thus, expenses for physicians are not reportable. The Board noted that the Minnesota legislature intended that payments made to other individuals falling within the definition of “practitioner” must be reported, but that the actual language of the new law is ambiguous. The Board suggested that manufacturers should be prepared to report payments to “nurse practitioners, physician assistants, and dental therapists” for calendar year 2014. The Board anticipates that the new law will be revised to include these specific categories of practitioners.