On Dec. 14, 2011, the U.S. Department of Health and Human Services (HHS)
proposed rule pursuant to § 6002 of the Patient Protection and
Affordable Care Act (PPACA), which is commonly known as the Physician
Payments Sunshine Act (Sunshine Act). The proposed rule provides details on
the process and requirements for the reporting of physician payments and
financial relationships as required by the Sunshine Act provisions. The
proposed rule will be published in the Federal Register on Dec. 19, 2011.
Most significantly, the proposed rule includes an announcement that HHS
will not require applicable manufacturers and GPOs to begin collecting
information required for disclosure on Jan. 1, 2012, as required by the
Sunshine Act. Rather, such collection will be required only after HHS
publishes a final rule. The Sunshine Act imposed a deadline of Oct. 1, 2011,
for the government to issue regulations. This deadline was intended to allow
reporting entities time to adapt before Jan. 1, 2012, when such entities
were required to commence data collection. However, much to the chagrin of
Senators Herb Kohl, D-Wis., and Charles Grassley, R-Iowa, and industry, the
government missed its deadline. In the proposed rule, HHS provides “[w]e
hope to finalize this rule as soon as possible during calendar year (CY)
After HHS reviews comments it will publish a final rule. HHS is seeking
comments on how much time reporting entities will need, following
publication of the final rule, to begin complying with the data collection
requirements of the Sunshine Act. Comments are due by Feb. 17, 2012.
A detailed summary of this rule is now available online.
McGuireWoods is available to assist clients with drafting and submitting
comments to HHS regarding the proposed rule. McGuireWoods advises
medical device and pharmaceutical manufacturers on compliance with state
marketing and transparency laws and on preparing for compliance with the
Sunshine Act. If you would like to discuss your company’s compliance with
these statutes and regulations, please contact the authors.