Physician Payment Sunshine Act: CMS Credits Delay on Reducing Regulatory Burden
Exactly two weeks after Senators Herb Kohl (D-WI) and Charles Grassley (R-IA), co-sponsors of the Physician Payment Sunshine Act (Section 6002 of the Affordable Care Act), asked the Centers for Medicare and Medicaid Services (CMS) to explain why the agency had missed the October 1, 2011 deadline for issuing proposed regulations, CMS Administrator Donald Berwick, MD sent a letter in response on Monday.
Berwick credited the delay on President Obama’s Executive Order 13563, which “directs all Federal agencies to take steps to reduce regulatory burden.” He asserted his belief that CMS could “implement the statutory goals of Section 6002 while minimizing burden on the regulated parties.” Accordingly, he explained that, “CMS is carefully reviewing this statutory requirement and working hard to ensure we meet these goals.”
Berwick also highlighted in his letter that, “CMS has been actively engaged in stakeholder outreach regarding the implementation of this provision.” He stated that, “immediately upon receiving the delegation of authority from the Secretary for Section 6002, CMS staff began engaging in stakeholder outreach to better understand the complexities involved with implementing this provision.”
He mentioned the CMS special Open Door Forum in March 2011, which had approximately 700 participants. Following the special Open Door Forum, CMS requested written feedback and received 19 written responses. Additionally, in the ensuing months, CMS staff met with 15 external stakeholder groups, including states, advocacy groups, manufacturers, and industry associations to receive feedback on the implementing procedures.
In addition, and as required in the statute, Berwick asserted that CMS staff has been engaged with the HHS Office of Inspector General to gather their input and assistance in developing implementing regulations. He also mentioned that CMS has had informal conversations with the Kohl and Grassley’s staff to relay the Congressional intent on this provision and he welcomed their input as CMS moved forward. Following the executive order does give us some insight as to timing. The order requires 60 days of public comment to allow input from those directly affected by regulations. So, it is not likely that there will be a final rule on sunshine anytime before second quarter of 2012.
Ultimately, Berwick did not respond directly to the concerns of Kohl and Grassley. While he explained the delay was caused by the regulatory review based on burden, which the Sunshine Act is likely to create a tremendous amount of, Berwick offered no insight into when the proposed regulations would be issued, causing further uncertainty for stakeholders. The fact that these regulations are already being considered burdensome should be a sign to many that whatever proposed regulations come from CMS will likely be troublesome both for stakeholders to implement and for CMS to carry out effectively. And of course, we have yet to hear how patients will benefit from the Sunshine Act and how taxpayers will see any savings.