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.

FDA Proposes Changes to Orphan Drug Regulations

This post was written by Areta L. Kupchyk, Kevin M. Madagan and Erin A. Janssen.

On October 19, 2011 the Food and Drug Administration (“FDA”) published a proposed rule in the Federal Register that would amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act (the “Proposed Rule”). Comments to the Proposed Rule should be submitted no later than January 17, 2012. This client alert summarizes these proposed changes and discusses the potential impact of the Proposed Rule on the drug, biological product, and biotechnology industry.

To read the full alert, click here.