When the physician self-referral statute (the Stark Law) was first enacted in 1989, it contained a financial relationship reporting requirement.
Although the initial regulations issued in 1991 contained information and details on that reporting requirement (42 CFR 411.361), CMS never initiated or implemented the requirement …. until now.
CMS first began to hint at its intention to begin to ask for disclosure of information on hospital/physician financial relationships in 2007 and, in its FY 2009 IPPS proposed rule suggested that it planned to send a formal information collection instrument known as the “Disclosure of Financial Relationships Report” (DFRR) to 500 hospitals (both acute care and specialty hospitals).
CMS suggests that the purpose for collecting this information is to: (1) identify arrangements that potentially may not be in compliance with the Stark Law; and (2) identify practices that may assist CMS in future rule making regarding the Stark Law.
Although CMS originally estimated that the effort associated with providing it with the information required on the DFRR would be minimal, it now acknowledges that hospitals may need to work with accounting and legal advisers in order to complete the DFRR.
Still CMS has indicated in the final IPPS rule for FY 2009 that each hospital who receives a DFRR will have only 60 days to complete the Report. In implementing this reporting requirement, CMS believes that the information it is requesting is that which a hospital should be keeping in the normal course of its business activities. CMS also hopes that hospitals who receive the DFRR will elect to submit their responsive information electronically, but hospitals will be able to submit information, including supporting documentation in a paper copy.
Fortunately, at least for now, CMS has determined that the DFRR will be used only in a one-time collection effort … at least for now. A final PRA notices will be published in the Federal Register in the near future that will include a revised DFRR, including revised instructions for completion. Following a 30 day comment period, CMS will then be in a position to begin formal distribution of the DFRR to a randomly selected group of 500 hospitals across the country.…