By Anne Wagstaff
More than 2 months after the October 1, 2011, deadline, the Centers for Medicare and Medicaid Services (CMS) has finally released the proposed rule that would implement the "Transparency Reports and Reporting of Physician Ownership or Investment Interests" section of the Patient Protection and Affordable Care Act (often referred to as the "Sunshine Act").
The proposed rule would require manufacturers of drugs, devices, biologicals, and medical supplies covered by Medicare, Medicaid, or the Children’s Health Insurance Program to report payments or other transfers of value made to physicians and teaching hospitals. It would also require manufacturers and group purchasing organizations (GPOs) to disclose physician ownership or investment interests.
Although the proposed rule is not scheduled to be published in the Federal Register until Monday, CMS issued a notice of proposed rulemaking yesterday and actually made available the unpublished rule.
So, what are the implications on timing for data collection and reporting?
In a lengthy preamble accompanying the draft rule, CMS is proposing that manufacturers and GPOs would not be required to begin collecting data for federal disclosure on January 1, 2012, but that they will be able to wait until the final regulations are issued sometime in 2012. As a result, manufacturers and GPOs would submit a disclosure report for only part of 2012 on March 31, 2013.
CMS will then aggregate these submissions and provide physicians and teaching hospitals 45 days to review the information before it is made publicly available by September 30, 2013. Applicable manufacturers and other interested parties will have until 5 pm Eastern Standard Time on February 17, 2012, to submit their comments on the proposed rule electronically; by regular, express or overnight mail; or by hand or courier.
Many in industry have been working frantically to meet the January 1, 2012 deadline to begin data collection, and perhaps some companies will forge ahead as planned and begin collecting, and perhaps voluntarily reporting their spend as of January 1.
For others, the proposed delay may be a welcome reprieve and an opportunity to prepare for compliance, now with the added benefit of the proposed rule. Either way, Happy Holidays!
Anne Wagstaff is a manager of regulatory & compliance services for Porzio Pharmaceutical Services LLC. She participates in various licensing projects by ensuring that all applications are accurate and prepared in accordance with relevant state laws and regulations. She is currently working on the PPS databases focused on keeping the industry apprised of various enforcement actions, and often conducts quality control reviews of current databases to confirm that they are accurate and current. Ms. Wagstaff is also an associate of the law firm of Porzio, Bromberg & Newman P.C. and a member of the firm’s Life Sciences Group.