In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). Pfizer, Inc. v. U.S. Department of Health and Human Services …
“EKRA” refers to the Eliminating Kickbacks in Recovery Act, which was part of the Substance Use – Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018. EKRA is codified at 18 U.S.C. § 220 and was described on HP&M’s …
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 …
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 …
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 …
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 …
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, …
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 …
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 …
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 …
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 …
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 …
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 …
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. 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 …
