Medical Device Legal News with Sam Bernstein: Episode 10
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Investment Management Roundtable Discussion – Regulatory and Enforcement Update
FCPA Compliance and Ethics Report-Episode 131, The FCPA Professor Takes a Look Back at 2014
On this Ropes & Gray podcast, health care partner Michael Lampert and counsel Sam Perrone, and litigation & enforcement partner Andrew O’Connor, rejoin to discuss patient assistance programs, recent enforcement actions, and...more
On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...more
Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more
On October 5, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-19 (Advisory Opinion), in which it determined that a proposed oncology drug discount arrangement could constitute grounds for the...more
On September 29, 2022, Massachusetts Attorney General Maura Healey announced that Medicaid managed care and pharmacy benefits giant Centene Corporation agreed to pay $14 million to resolve claims that it overcharged...more
A new California law (AB 1278) will require physicians and their employers to provide patients with several forms of notices about the Open Payments database, starting January 1, 2023. The law is intended to increase...more
On August 7, 2022, the U.S. Senate passed the Inflation Reduction Act of 2022, which includes some of the most significant drug pricing-related changes since the passage of the Medicare Prescription Drug Improvement...more
On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more
William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more
On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more
On March 18, 2021, OIG issued Advisory Opinion 21-01, addressing whether a pharmaceutical manufacturer may provide a personalized medicine made from a patient’s own cells as a one-time, potentially curative treatment (the...more
FDA’s recent release of new guidance on civil money penalties for the failure to submit required information to the ClinicalTrials.gov data bank may indicate a renewed interest in the enforcement of these requirements. On...more
The Department of Justice’s (“DOJ”) most recent settlement with Indivior Solutions, Inc., Indivior Inc., and Indivior plc (together, “Indivior”) demonstrates not only that the DOJ is continuing its pursuit of claims and...more
Time Is Ripe To Update SOPs And To Ensure Compliance with Results Submission Requirements - In recent days, the federal Department of Health and Human Services (“HHS”) clarified the requirements for submission of certain...more
In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more
The Department of Justice (DOJ) announced this month that it obtained over $3 billion in settlements and judgments from civil fraud and false claims cases during the fiscal year ending September 30, 2019 (FY 2019). Of this...more
In its last Advisory Opinion of 2019 (19-06), the OIG approved a proposed arrangement involving a retailer rewards program through which out-of-pocket costs on in-store pharmacy purchases would qualify customers for future...more
On December 17, 2019, OIG published Advisory Opinion 19-06 approving a supermarket’s expansion of a loyalty program to allow customers to earn rewards points on out-of-pocket costs paid in connection with the purchase of...more
Cyberliability insurance provider Beazley Insurance Company has analyzed its internal breach response data and determined that in its experience, there has been a thirty-seven percent (37%) increase in ransomware attacks this...more
In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...more
The U.S. Department of Health and Human Services, Office of Inspector General (OIG), recently published its Spring 2019 Semiannual Report to Congress. The report, released June 3, 2019, covers the period October 1, 2018...more
If you overheard Medicaid providers breathe audible sighs of relief on April Fool’s Day, it may be because on April 1, 2019, the Health Resources & Services Administration of the Department of Health and Human Services...more
President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more
On February 1, 2019, the Ontario Ministry of Health and Long-Term Care (“Ministry”) announced that CWC Pharmacies (Ontario) Ltd. (“Costco Pharmacies”), a subsidiary of Costco, was ordered to pay an Administrative Monetary...more
Last week, the federal HHS Office of Inspector General (OIG) gave the greenlight to allow a virtual care company and pharmaceutical manufacturer to loan patients free smartphones, so the patients (which include Medicare...more