GRASSLEY URGES ACTION ON SUNSHINE ACT
In a January 22 letter to the White House, Sen. Chuck Grassley (R-IA) bemoaned the administration’s continued delay in implementing the Physician Payments Sunshine Act, part of the Patient Protection and Affordable Care Act (PPACA). The Sunshine Act requires that physicians report to the Department of Health and Human Services (HHS) their ownership and investment interests in, and payments or gifts that they receive from, manufacturers of drugs, devices and supplies.
Last May, the Centers for Medicare & Medicaid Services (CMS) announced that it would not require data collection under the Sunshine Act until January 1, 2013, to allow manufacturers to prepare for data submission and for CMS to have time to fully address the input it received in more than 300 comments from the public. The Sunshine Act required CMS to issue final regulations by October 1, 2011, but that expected guidance to pharmaceutical and medical device manufacturers has not yet been released.
Sen. Grassley, who co-authored the Sunshine Act with Sen. Herb Kohl (D-WI), has repeatedly expressed concern regarding the implementation delays. His letter urged the administration to release the final rules, which were delivered to the White House’s Office of Management and Budget on November 28 for review, “without further delay.”
HHS AWARDS NEW EXCHANGE GRANTS
On January 17, HHS announced that it had awarded $1.5 billion in new grants to 11 states to fund the establishment of online “Affordable Insurance Exchanges” as provided under PPACA. In the latest round of grants, Delaware, Iowa, Michigan, Minnesota, North Carolina, and Vermont received “Level One” Exchange Establishment Grants, while California, Kentucky, Massachusetts, New York, and Oregon received multi-year “Level Two” Exchange Establishment Grants. Level One grants are issued to states to begin building their exchanges and Level Two grants are issued to states that are further along in the process. CMS intends to continue awarding Exchange Establishment Grants through 2014.
The Center for Consumer Information & Insurance Oversight (CCIIO), part of CMS, maintains a comprehensive website with updated information on state exchanges, including a map with details and amounts of the Exchange Establishment Grants awarded to each state. Every state but Alaska has applied for and received at least a Planning Grant, and 34 states and the District of Columbia have received at least a Level One grant.
Thus far, 17 states plus DC plan to operate their own exchanges, and seven other states plan to operate exchanges in partnership with the federal government. The deadline for states to elect to operate a partnership model exchange is February 15. In states that do not run their own exchanges, either alone or as a partnership, the federal government will operate a “federally facilitated exchange.” State exchanges are scheduled to being accepting enrollment applications on October 1, 2013, and providing health insurance coverage on January 1, 2014.
Edwards Wildman’s Healthcare Practice Group will continue to monitor healthcare news from Capitol Hill, CMS, HHS, and other federal and state agencies and courts, and will bring you timely updates as new developments occur.