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 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
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
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
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
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
On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more
As of September 1, 2023, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) can officially begin enforcement against Certified Health Information Technology (“HIT”) developers, health...more
OIG released its Semiannual Report to Congress (the Report) which summarizes the agency’s activities from October 1, 2022, through March 31, 2023 (the Reporting Period). Among other accomplishments, the Report highlights...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 August 19, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-16 (Advisory Opinion) in which it declined to impose sanctions for an arrangement under which the requestor provides gift cards to...more
On September 30, 2021, OIG posted Advisory Opinion No. 21-14 regarding a chiropractor’s proposal to extend an existing discount program covering a package of services to include federal health care program beneficiaries. OIG...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
The Office of Inspector General (OIG) recently issued a favorable advisory opinion (Advisory Opinion) to a university health system (Requestor) regarding two arrangements: (1) a proposal to waive cost-sharing obligations of...more
With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more
On December 7, 2016, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited final rule (Final Rule) that expands the safe harbor regulations under the Anti-Kickback Statute (AKS)...more
On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more
On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more
On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more
On September 19 and 27, 2016, the US Department of Justice announced two False Claims Act settlements that required corporate executives to make substantial monetary payments to resolve their liability. How will director and...more
On Thursday, October 29, 2015, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) jointly issued a rule (the “Final Rule”) to finalize five (5) waivers of certain fraud and abuse...more
On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more
The Office of Inspector General at the U.S. Department of Health and Human Services (“HHS-OIG”) announced, on June 30, 2015 (during a health care conference), the creation of a new litigation team that will focus solely on...more
On June 9, 2015, the U.S. Department of Health and Human Services Office of the Inspector General (OIG) released a Fraud Alert regarding recent settlements with 12 individual physicians who were party to questionable medical...more
Continuing an accelerating series of EMTALA investigations and settlements in 2014 and this year, a Newton, Kansas hospital has agreed to pay $45,000 to settle allegations by the Office of the Inspector General (OIG) of the...more
In This Issue: - OIG Releases Proposed Rule Revising the Anti-Kickback Statute Safe Harbors and Civil Monetary Penalty Rules ..AKS Safe Harbors ..Revisions to the Civil Monetary Penalty Regulations ...more