Analysis of Proposed Rules in Support of the PPACA 

On December 19, 2011, the Centers for Medicare & Medicaid Services (CMS) published the proposed rule implementing the transparency provisions set forth at section 6002 of the Patient Protection and Affordable Care Act (PPACA).

The following summary is intended to serve as an overview of the proposed rule. CMS will receive public comments up until 5:00 p.m Eastern Standard Time on February 17, 2012.

According to the proposed rule, manufacturers will not be required to begin collecting the data until after the final rule is published. CMS is considering requiring manufacturers to begin collecting data 90 days after the date of publication of the final rule. Manufacturers would then be required to submit an interim report on or before March 31, 2013.

Section 1128G of PPACA outlines the transparency reporting requirements as it relates to (1) required reports from applicable manufacturers on payments or other transfers of value to covered recipients; and (2) reporting requirements for applicable manufacturers and GPOs concerning ownership and investment interests of physicians (including immediate family members) as well as information on any payments or transfers of value made to physician owners or investors. In order to clearly distinguish
between these two reporting requirements, CMS proposes that these two types of information be reported separately.

In addition to the proposed rule, CMS provided an Addendum consisting of sample reporting templates for payments or other transfers of value (Section 1128G(a)(1)) as well as physician ownership or investment interests (Section 1128G(a)(2)).

The following summary reviews the proposed rule consistent with the delineation set forth above. The various sections of the proposed rule are set forth in full followed by “Commentary” that is intended to serve as a distillation of the rationale and/or interpretation provided by CMS. Because these are proposed rules, CMS is seeking comments from interested parties to help guide the formulation of the final rules.

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