As pharmaceutical and medical device manufacturers diligently prepare for transparency reporting pursuant to the Physician Payment Sunshine Act (incorporated into the Patient Protection and Affordable Care Act), the Centers for Medicaid and Medicare Services (CMS) quietly missed their deadline for producing implemented regulations as required by 42 U.S.C.A. § 1320a-7h(c)(1)(A). On October 3rd, CMS was called to the carpet by the sponsors of the Physician Payment Sunshine Act, Senators Charles Grassley and Herb Kohl (see Letter here).
According to the correspondence addressed to the Administrator of CMS, the implementing regulations were provided to the Office of Management and Budget (OMB) on or before September 23, 2011. Senators Grassley and Kohl have requested that CMS provide answers to the following no later than October 14, 2011:
- What is [CMS’] timetable for implementing the Sunshine Act?
- Date the proposed rules were sent to the OMB as well as the dates that follow-up was conducted along with the reason for the follow-up?
- Why CMS has failed to meet the statutory deadline?
- Anticipated release date of the preliminary regulations? The length of the comment period as required by the statute as well as the timeline for issuing final regulations.
Lastly, Senators Grassley and Kohl admonished CMS for missing the required deadline and failing to conduct "adequate consultation with either industry representatives or consumer advocates" and thereby creating confusion on the part of both manufacturers and consumers and potentially placing tax dollars at risk.
Stay tuned for further updates as they become available . . . As always, please let us know if you have any questions or comments and feel free to email us at Info@mediSpend.com.