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Affordable Care Act: Where's the Sunshine?


Pharmaceutical Executive

The Senate Special Committee on Aging is holding a Roundtable discussion on Wed. Sept. 12.

The Senate Special Committee on Aging is holding a Roundtable discussion on Wed. Sept. 12, 2012 in hopes of spurring action to implement the “Sunshine” provisions of the Affordable Care Act (ACA). Policies for collecting and submitting information on pharma payments to doctors were supposed to be issued by last September (2011), so that industry would be able to meet requirements for tracking payments starting in January 2012. But the program was put on hold for a year because the Department of Health and Human Services (HHS) still has not finalized implementing regulations. Committee chairman Herb Kohl (D-Wis) scheduled a hearing last December when no regs had appeared, which prompted HHS’ Center for Medicare and Medicaid Services (CMS) to hustle out a proposed rule just before the planned session. Kohl hopes that the Roundtable produces a similar response, as he’s retiring at the end of the year and wants to see the Sunshine program up and running to cap his public career.

Meanwhile, CMS staffers have been poring over some 300 comments to the proposed regs, but refused to set a date for the final rule at the August Sunshine and Aggregate Spend Forum sponsored by CBI. Niall Brennan, director of the CMS Policy and Data Analysis Group, described the difficulties in establishing an IT system that can absorb millions of data points without linking the wrong payments to the wrong doctor. CMS’ Center for Program Integrity will run the program and continues to struggle with basic definitions, as for “covered recipient” and “physician ownership and interest.” Doctors are pressing for a clear, formal process for reviewing data and resolving disputes, and research institutes are up in arms over the prospect of double counting research payments to investigators and organizations. Pharma, biotech and medical device companies want to see the final rules now so they can fine tune data collection systems before year-end. Sen. Kohl, according to his staff, wants a workable Sunshine system that is not overly burdensome and can help patients make health care choices.

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