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
The United States Department of Health and Human Services, Office of Inspector General (“OIG”) recently released two unfavorable advisory opinions, OIG Advisory Opinion No. 25-04 and -08 (the “Opinions”) to medical device...more
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 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more
The Department of Justice (DOJ) and the Office of the Inspector General for the Department of Health and Human Services (OIG) have historically focused their virtual health care enforcement efforts on “traditional”...more
As the shift toward value-based care continues to transform the healthcare industry, hospitals and health systems are increasingly utilizing incentive-based physician compensation structures. Incentive-based compensation...more
On December 11, 2024, OIG issued a Special Fraud Alert to warn the industry about the fraud and abuse risks associated with abusive Medicare Advantage (MA) organization (MAO) and agent and broker relationships with healthcare...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
On July 8, 2024, OIG updated the Frequently Asked Questions on its website, adding four new questions and answers to its General Questions Regarding Certain Fraud and Abuse Authorities...more
On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more
On June 24, 2024, the Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) released a final rule that disincentivizes healthcare providers from...more
The Department of Health & Human Services’ Office of Inspector General (HHS OIG) and U.S. Department of Justice (DOJ) have published important guidance and recommendations for pharmaceutical companies to develop and implement...more
The federal False Claims Act (FCA) is widely regarded as a powerful tool to punish fraud against the federal government. Since 1986, the federal government has recovered more than $75 billion from FCA settlements and...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
The Office of Inspector General (OIG) recently issued a new favorable OIG Advisory Opinion, concluding that, although the proposed arrangement (“Proposed Arrangement”) between a Medicare Supplement insurer (“MediGap Plan”)...more
Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more
Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more
As the Sunshine Act reporting deadline of March 31, 2024 draws near, medical device and pharmaceutical companies are gearing up for their Sunshine Act reporting. Are you prepared for a Sunshine Act audit? Reporting...more
The government continued to dedicate enormous resources to investigating and prosecuting fraud against COVID-19 pandemic relief programs in 2023. While we observed some civil False Claims Act settlements, criminal enforcement...more
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) is tasked with providing objective oversight to protect the integrity and promote the efficiency of Medicare, Medicaid, and more than...more
Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more
This favorable OIG opinion concludes that although the proposed arrangement (“Proposed Arrangement”) to subsidize Medicare cost-sharing obligations for Medicare patients in a cardiac clinical trial (“Study”) would constitute...more
The Office of Inspector General (OIG) recently issued two identical favorable OIG Advisory Opinions, concluding that, although the proposed arrangement (“Proposed Arrangement”) between a Medicare Supplement insurer (“MediGap...more
On Oct. 20, 2023, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued unfavorable Advisory Opinion 23-08 (AO 23-08), continuing its long-held position that the provision of value-added...more