On April 29, 2003, the Office of Inspector General ("OIG") of the Department of Health and Human Services ("HHS") released its final "Compliance Program Guidance for Pharmaceutical Manufacturers" ("Final Guidance"), which outlines voluntary actions manufacturers should consider to promote compliance with Medicare, Medicaid, and other federal health care program rules and guidelines. This Final Guidance finalizes the draft Compliance Program Guidance ("Draft Guidance") issued by the OIG on October 3, 2002, and described in detail in our memorandum to clients on that date. The Final Guidance retains many of the policies and principles set forth in the Draft Guidance. At the same time, the OIG has added clarifications and additional discussion in a number of areas, including the relationship between pharmaceutical manufacturers and pharmacy benefits managers ("PBMs"), the practice of "preceptorship" or shadowing and other consulting arrangements, manufacturer influence on formulary decisions, and more. Also, unlike in the Draft Guidance, the OIG notes that the compliance program elements and potential risk areas identified in the Final Guidance "may have application to manufacturers of other products that may be reimbursed by federal health care programs, such as medical devices and infant nutritional products."