Recent posts on www.lifescienceslegalupdate.com include:
"Current Issues Under The Civil False Claims Act: Worthless Services, Off-Label Use, and More" which briefly identifies relevant criminal and civil provisions relating to these issues, and then focuses more closely on recent uses of the civil False Claims Act ("FCA") in government investigations of health care providers, suppliers, and manufacturers, including a section on state false claims legislation. Finally, it discusses the issue of distinguishing overpayments from false claims and provide information on the voluntary disclosure program of the Office of the Inspector General ("OIG") of the Department of Health and Human Services (HHS). https://www.lifescienceslegalupdate.com/2009/01/articles/product-liability/offlabel-use/current-issues-under-the-civil-false-claims-act-worthless-services-offlabel-use-and-more/
...and "Life Sciences Industry Members Who Contract With Government Should Note Recent Amendment to the Federal Acquisition Regulation" which discusses an amendment to the Federal Acquisition Regulation ("FAR") to establish: (1) mandatory disclosure requirements for certain violations of federal criminal law and the False Claims Act; (2) requirements for contractors to establish and maintain specific internal controls to detect, prevent, and disclose improper conduct in connection with the award or performance of any government contract or subcontract; and (3) new causes for suspension and debarment. See 73 Fed. Reg. 219, 67,064 (Nov. 12, 2008). https://www.lifescienceslegalupdate.com/2009/01/articles/regulatory-developments/life-sciences-industry-members-who-contract-with-government-should-note-recent-amendment-to-the-federal-acquisition-regulation/… Continue Reading
This post was also written by Matthew E. Wetzel. On December 18, 2008, the Advanced Medical Technology Association (“AdvaMed”), the national trade association of medical technology manufacturers, issued a revised Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code” or “Code”). The revised AdvaMed Code, which becomes effective July 1, 2009, contains … Continue Reading
This post was also written by Robert J. Hill and Kathleen McGuan. I. INTRODUCTION On July 15, 2008, the House and Senate overrode President Bush’s veto of H.R. 6331, the “Medicare Improvements for Patients and Providers Act of 2008” (“MIPPA”).1 Among many other things, MIPPA delays and reforms the Centers for Medicare & Medicaid Services’ (“CMS”) … Continue Reading
I. INTRODUCTION On January 8, 2008, CMS announced the second phase of Medicare competitive bidding for durable medical equipment (“DME”), prosthetics, orthotics, and supplies (“DMEPOS”). In this second round, competitive bidding will be implemented in 70 areas, including the nation’s largest cities. The complete list of areas can be found at Appendix 1. With very … Continue Reading
