Yesterday Senators Kohl and Grassley submitted a letter to CMS seeking information on the implementation of the Sunshine Act – the legislation passed and signed into law that would put into place a system for public reporting of the financial transactions between medical product manufacturers and medical providers. Many will recall that last fall, CMS missed the deadline for outlining its plans for how it would collect and report on financial transaction data. At the time that prompted a letter from Senator Grassley inquiring when the agency would get around to doing so. Yesterday, another letter went out.
“We are disappointed that regulations implementing the Sunshine Act were not complete by the statutory deadline of October 1, 2011. We request that the final rule on implementation be released no later than June of this year so that partial data collection for 2012 can commence.”
In addition, there was some specific direction. In the letter they urge that CMS define very specific categories for payments and urged a removal of a catchall “other” category that could serve to obscure the nature of some transactions. In addition, the Senators took issue with the proposed yearly schedule for correcting mis-reporting to the public site stating rather that errors should be corrected as the error becomes known.
Additionally the letter expressed concern regarding the design of the Web site that will serve as the vehicle for reporting the information to the public. Given the potential for public attention to the information – and the many ways that information can be interpreted – the Web site clearly takes on as important a role as the very type of data that is collected. Therefore, the letter urged that the site be thorough and user-friendly complete with definitions to understanding the nature of the transactions and all of the entities involved.
The letter closes by posing a set of particular questions:
- Can CMS commit to completing a final rule by this summer so that data collection can begin in 2012?
- Since CMS missed the initial required Congressional deadline, has CMS increased the resources or personnel assigned to the implementation of the Sunshine Act, including a dedicated information technology lead?
- Will CMS commit to issuing an RFP to begin designing the website?
- Does CMS have a dedicated working group assigned to the implementation of the Sunshine Act, and what technical expertise and program areas are represented?
- Does CMS have a public education and outreach plan to raise awareness of the new law with the provider community and with health care consumers?
- Has CMS allocated dedicated implementation funds for the Physician Payment Sunshine Act?
While these are questions posed by the Senators to CMS, medical product manufacturers may do well to ask themselves variations along these lines. Many have voluntarily begun to report data on their Web sites, but that may have to be changed to more accurately reflect the categories and prominence of the CMS undertaking. How will mistakes in reporting be dealt with? How will patients and providers be educated? Even as CMS ponders its response to these inquiries, it is a good time for all to consider what form individual company responses will take.