Understanding the Sunshine Act—Part Two

April 10, 2012 · Leave a comment

Industry Insights from Kristen Smithwick

Last week proved to be another interesting week for the developing Sunshine Act. Senators Chuck Grassley (R-IA) and Herb Kohl (D-WI) sent a pivotal memo to Acting CMS Administrator Marilyn Tavenner. The senators urged the agency to publish a final rule no later than June 2012 and to respond to several questions related to implementation.

Senators Grassley and Kohl want the agency to begin gathering transparency data this year, and they’re not willing to give CMS any wiggle room for delays. To meet the senators’ timeline, CMS will need to address comments and recommendations from numerous interested parties, especially the Pharmaceutical Research and Manufacturers of America (PhRMA), the Advanced Medical Technology Association (AdvaMed), and the Biotechnology Industry Organization (BIO). We covered a number of areas questioned in Part 1 of this blog. In this post, we’ll mention just a few additional areas of concern.

Definition of Applicable Manufacturer and Separate vs. Consolidated Reporting – Questions and concerns abound when it comes to defining applicable manufacturers, especially as the definition impacts requirements for separate vs. consolidated reporting for entities with common ownership. The challenge for CMS will be to ensure the definitions of applicable manufacturers and common ownership are broad enough to meet the public’s demand for transparency, while being specific enough to protect the ... read more »

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Understanding the Sunshine Act—Part One

March 27, 2012 · Leave a comment

Industry Insights from Kristen Smithwick

Albeit a bit late, the U. S.  Centers for Medicare and Medicaid Services (CMS) issued a proposed rule on the Patient Protection & Affordable Care Act’s Physician Payments Sunshine Provision (also known as the “Sunshine Act”) to implement it as law.

CMS invited comments on the proposed rule through mid-February 2012, and a recent webcast, sponsored by PharmaLive’s Pharmalot, featured key facts and summaries of comments on the proposed rule. Working for a provider of research and consulting to the biopharmaceutical, medical device, and diagnostics industries on relationships with physicians and other health care providers, I enjoyed the opportunity to join the webcast, led by experts from Buchanan Ingersoll & Rooney, P.C., and am eager to share some of my key takeaways.

As mentioned in previous Thought Leader Select Blog posts, the Sunshine Act, as with many laws and regulations, is full of unintended consequences – some positive and some negative. Lance K. Stell, medical ethics teacher at Davidson College and Carolinas Medical Center, reports in his USA Today op-ed piece that the “Sunshine Act will cost far more than the $224 million estimated for just the first year of compliance” and that “the biggest cost will be the valuable, socially useful physician-industry collaborations that simply won’t occur.” Of course, the idea of ... read more »

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