Criticism mounts over delay in Physicians Sunshine Act implementation

While the 'agg spend' rules sit in the Office of Management and Budget, healthcare advocacy groups fume

CMS had to be prodded by Congress and others to keep to some schedule in issuing the regulations on the Physicians Sunshine Act, a part of the Affordable Care Act passed in 2010 that requires pharma and med device companies to collect and report, to CMS, the money they spend with physicians and other healthcare providers. Once submitted, CMS is required to make the expenditures public. After considerable delay, and with CMS moving the start date for reporting data to itself from 2012 to March of this year, proposed final rules were sent from CMS to OMB in late November. And there they have sat.

One letter has been written by a group of healthcare advocacy organizations, including AARP, AFL-CIO, Community Catalyst and 16 others, telling OMB that “we are deeply concerned that additional delay in implementation will undermine the original Congressional intent behind these key consumer protection and transparency provisions.” Another statement, from the Healthcare Supply Chain Assn. (Washington, DC), a GPO trade association, noted that “We are now fifteen months past the statutory deadline for this vital regulation, the sooner the healthcare supply chain realizes full implementation of the Physician Payments Sunshine Act’s provisions, the sooner patients will realize the benefits.”

On the flip side, as late as October 2012 (as CMS was finishing its proposed final rules) the American Medical Assn. was raising basic questions about how the law should be implemented, particularly the use of the Office of Program Integrity (which usually investigates fraud claims) to administer the effort.

Industry hasn’t been sitting on its hands awaiting the rules; most major pharma companies have IT projects under way to “aggregate” spending by physician (including items of value provided by sales reps; research projects funded by manufacturers, and investments by physicians and healthcare providers in manufacturing entities)—but many have been awaiting the final rules. Meanwhile, several states have their own agg spend rules in place, including Massachusetts, Minnesota, Vermont, Colorado and West Virginia. Additionally, numerous pharma companies, either voluntarily or as part of a corporate integrity agreement with the US Dept. of Justice, have been reporting data. (A fairly up-to-date repository of these data is PharmaShine, a private company that sells institutional subscriptions to its database; it claims data on over two million transactions since starting up in 2009.)

When—if ever—the agg spend rules are finalized and data begins to be publicly reported, both industry and healthcare providers will have a lot of explaining to do, but there will probably be more surprise among providers: a year-old survey from MMIS (Portsmouth, NH) found that nearly one in two physicians was unaware of the Sunshine Act.