Senators Grassley and Kohl Urge CMS to Take Action on Sunshine

CMS missed its statutory deadline for issuing regulations under the federal “Physicians Payment Sunshine Act,” which did not go unnoticed by the law’s sponsors,  Senators Grassley and Kohl.   On October 3rd, the Senators penned a letter expressing their “severe disappointment” in CMS for missing the deadline and otherwise failing to consult with industry or consumer advocates on the outstanding questions and issues.   The law makers wrote that they “are concerned that CMS’s failure to implement the statutory provisions on time with clear guidance, standards and definitions will create confusion among both manufacturers and consumers, potentially placing taxpayer dollars at risk,” and requested CMS responses to the following questions in writing no later than October 14, 2011:

1. What is your timetable for implementing the Sunshine Act?
2. When did you originally send the proposed rule to the Office of Management and Budget (OMB)?  Please include any dates that follow-up was conducted and for what reason.
3. Why have you failed to meet the statutory deadline?
4. What is the anticipated release date of the preliminary regulations?  How long will the regulations be open for comment as required by the statute?  What is your timeline for issuing final regulations?

Interestingly, CMS represented that they submitted the draft regulations to the Office of Management and Budget (OMB) for review on Friday, September 23, 2011.  However, there are no references on the OMB website relating to such review.  Either way, it appears that the Sunshine regulations are imminent, so stay tuned.

Click here to review the text of the Grassley/Kohl letter.