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  • Fraud and Abuse

    • CMS and OIG Propose Changes to the Stark Law, Anti-Kickback Statute and Civil Monetary Penalty RuleOctober 22nd, 2019

      In the Federal Register of Thursday, October 17, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) both published substantial amendments to the regulations implementing the Medicare physician self-referral law (commonly referred …

    • Laboratories Beware of EKRAMarch 5th, 2019

      On October 24, 2018, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients and Communities Act was signed into law (the Act’s text is available here).  The SUPPORT Act includes a number of provisions to address the ongoing opioid crisis, such …

    • OIG Finalizes Antikickback Law Safe Harbors and CMP Rules that Would Offer Additional Protections for Pharmaceutical and Device ManufacturersDecember 15th, 2016

      On December 7, 2016, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a Final Rule amending the safe harbor regulations under the Federal health care program antikickback statute (“AKS”) (42 U.S.C. § 1320a-7b(b)) and established exceptions to the Civil Monetary …

    • DOJ Weighs in on Discount Safe HarborOctober 13th, 2016

      By Serra J. Schlanger & Alan M. Kirschenbaum – We previously reported (here and here) on two opinions handed down by Judge Rya Zobel of the Federal District Court for the District of Massachusetts construing the discount safe harbor under the Federal health care program antikickback …

    • Massachusetts District Court Guts Discount Safe HarborSeptember 14th, 2016

      By Serra J. Schlanger & Alan M. Kirschenbaum – For 25 years, drug and device manufacturers and their customers have relied on the discount safe harbor under the Federal health care program antikickback statute (“AKS”) to protect procompetitive discount arrangements that save money for purchasers, patients, …

    • OIG Issues Favorable Advisory Opinion on Drug Manufacturer’s Direct-To Patient Discounted Drug Sales ProgramJuly 29th, 2014

      By Jay W. Cormier & Alan M. Kirschenbaum – In an advisory opinion posted on Monday, July 28, 2014, the Office of the Inspector General of the Department of Health and Human Services (“OIG”) determined that no enforcement action would be taken against a drug manufacturer’s …

    • Updated Version of HP&M Fraud and Abuse Outline Covers Devices as Well as DrugsJanuary 5th, 2014

      By Alan M. Kirschenbaum – Hyman, Phelps & McNamara, P.C. has updated the firm’s outline on the Application of the Health Care Fraud and Abuse Laws to the Marketing of Pharmaceuticals and Medical Devices.  The outline, which was last updated in 2009, has been expanded to …

    • Massachusetts Issues Final Rule on Drug and Device Manufacturer Marketing ConductNovember 27th, 2012

      By Bill Koustas & Alan Kirschenbaum – In July, we reported that Massachusetts had amended its prescription drug and device marketing law to (among other things) allow pharmaceutical and medical device companies to provide “modest meals and refreshments” as part of an informational presentation to …

    • Lack of Regulatory Guidance Fatal to Some, But Not All Claims in AMP False Claims Act CaseJuly 19th, 2012

      By JP Ellison –  In a July 3, 2012 memorandum opinion out of the Eastern District of Pennsylvania, the court granted in part and denied in part the defendants’ motion to dismiss the plaintiff’s claims for failure to state a claim.  The case, United States of …

    • Massachusetts Relaxes Laws on the Offering of Prescription Drug Coupons and Meals to Health Care PractitionersJuly 16th, 2012

      By Nisha P. Shah – On July 8, 2012, Massachusetts Governor Deval Patrick signed H. 4200, which, in part, relaxes: (1) the state anti-kickback law to permit the offering of coupons for prescription drug and biological products, and (2) the marketing laws to allow prescription drug …

    • OIG Issues Advisory Opinion on Manufacturer-Subsidized Patient Reminder ProgramJune 13th, 2011

      By Peter M. Jaensch & Alan M. Kirschenbaum – The Office of the Inspector General (“OIG”) of the Department of Health and Human Services has issued a favorable Advisory Opinion on a manufacturer-sponsored patient reminder program for a vaccine, concluding that OIG will not seek penalties under …

    • Settlement in False Claims Act Suit is no bar to suing the ConsultantDecember 1st, 2009

      By Jeffrey N. Wasserstein – We missed this interesting decision in the run-up to Thanksgiving.  Now that we’ve recovered from our tryptophan-induced sleepiness, we found this case to be of particular interest.  We previously blogged on the Cell Therapeutics Inc. (“CTI”) case.  To sum up …

    • Hyman, Phelps & McNamara, P.C. Updates Fraud and Abuse OutlineFebruary 2nd, 2009

      Hyman, Phelps & McNamara, P.C. today posted on its website an updated version of its outline entitled “Application of Health Care Fraud and Abuse Laws to Pharmaceutical Marketing."  This 89-page outline, authored by Alan Kirschenbaum and Jeff Wasserstein,  provides a comprehensive overview of how the …

    • Physician Payment Sunshine Act Moving Forward in CongressOctober 9th, 2008

      First introduced in September 2007 as S. 2029 by Senator Charles Grassley (R-IA), the ranking member of the Committee on Finance, and Senator Herb Kohl (D-WI), the Chair of the Special Committee on Aging, the Physician Payment Sunshine Act is progressing through Congress. Representatives Peter …

    • Senate Finance Committee Releases Report on Drug Industry CME GrantsMay 8th, 2007

      On April 25, 2007, the Senate Finance Committee released the results of a Committee inquiry into drug company grants to fund continuing education for medical providers.  The Finance Committee report was two years in the making and addresses the Committee’s belief that the pharmaceutical industry …