Overview and Analysis of the Proposed Federal Sunshine Regulations

On December 19, 2011, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule (the “Proposed Rule”) related to section 6002 of the Affordable Care Act, commonly referred to as the “Physician Payment Sunshine Act.” The Physician Payment Sunshine Act requires applicable manufacturers of drugs, devices, biologicals, or medical supplies covered under Medicare, Medicaid, or CHIP to report annually to the Secretary of the Department of Health and Human Services (“Secretary”) certain payments or other transfers of value to physicians and teaching hospitals. Additionally, applicable manufacturers and applicable group purchasing organizations (“GPOs”) must report certain information regarding the ownership or investment interests in them that are held by physicians or their immediate family members.

To learn more about this development regarding the Physician Payment Sunshine Act, please see the full post written by Elizabeth B. Carder-Thompson, Katie C. Pawlitz, Nancy E. Bonifant and Debra A. McCurdy on Reed Smith’s Health Industry Washington Watch blog.

Health Care Companies Operating in France to be Subject to New Sunshine/Transparency Rules

This post was written by Marina Cousté, Benoît Charot, François Jonquères and Daniel Kadar.

Health care and cosmetic companies operating in France are subject to new transparency requirements, comparable to the U.S. "Sunshine Act," that were adopted in December 2011. As discussed in a recent posting on Reed Smith's Global Regulatory Enforcement Law Blog, in addition to imposing a general disclosure obligation on any company manufacturing or commercializing products with a medical or cosmetic purpose, the new law sets forth new pharmacovigilance requirements and provides more stringent rules concerning the advertisement of drugs and medical and diagnostics devices.