Despite growing pressure from both consumer groups and industry groups, the Physician Payments Sunshine Act (the Act) final rule has not yet been published. However, the rule is one step closer to final release, as it is now in the hands of the Office of Management and Budget for review.

Requiring annual reporting of payments between applicable drug or device manufacturers and physicians or teaching hospitals, the Act is intended to shed light on these financial relationships. The Department of Health and Human Services will foster transparency for both consumers and the federal government by publishing this data on a public website and sending annual reports to Congress.

The delay of the highly anticipated final rule follows the delayed release of the proposed rule late last year, and the postponement of several other key Act implementation deadlines. Under the statute, data collection was to begin January 2012. However, due to the modified timeline, the Centers for Medicare and Medicaid Services announced earlier this year that collection would not begin until January 2013. Applicable manufacturers must begin disclosing required physician payment data 90 days after the release of the final rule.

The final rule has been long-awaited by interested parties. Consumer groups have criticized the publication timeline for placing implementation of the Act over a year behind schedule. Drug and medical device groups likewise have criticized this delay, as they worry they will not have adequate time to prepare for what many view as the burdensome requirements under the Act.

More information on the Sunshine Rule is available via the Bloomberg BNA article below.

Bloomberg BNA – “Long-Awaited Final ‘Sunshine’ Rule Lands at OMB for Regulatory Review”