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 Administrative False Claims Act (AFCA), enacted in December 2024, expands agency authority and recovery limits, making the AFCA a more powerful tool for recouping government funds lost to alleged false claims—a...more
The CFPB has continued to announce additional procedural, rulemaking and administrative changes, with the latest being three postings to the Federal Register on June 18, 2025: 1) a final rule rescinding the Procedure Relating...more
Every health care provider has “credit balances,” which occur when a provider receives more money than it is owed for services rendered. Credit balances can be caused by a number of factors, including incorrect coding,...more
On January 6, 2025, the Federal Energy Regulatory Commission (FERC) issued a Final Rule to amend its regulations governing the maximum civil monetary penalties assessable for violations of statutes, rules and orders within...more
The U.S. Department of the Treasury ("Treasury") has engaged in a flurry of rulemaking over the last year, most recently issuing a final rule to sharpen and enhance the Committee on Foreign Investment in the United States...more
Under a long anticipated Centers for Medicare & Medicaid Services (CMS) final rule that took effect in October, casualty insurers face risks of incurring Civil Money Penalties (CMPs) if they fit the Section 111 definition of...more
The Centers for Medicare & Medicaid Services (CMS) recently made meaningful changes to its regulations interpreting the Affordable Care Act’s (ACA’s) so-called “60-day Rule,” which requires Medicare providers to affirmatively...more
On Friday, November 1, 2024, the Center for Medicare & Medicaid Services (CMS) issued the display copy of the final rule interpreting the 60-day Refund Rule for Medicare Parts A/B (Traditional Medicare) and C/D (Medicare...more
On October 16, 2024, the Federal Trade Commission announced a final “click-to-cancel” rule that will require sellers to make it as easy for consumers to cancel their enrollment as it was to sign-up. Most of the final rule’s...more
As previously blogged about here, following notices of proposed rulemaking in 2022 and 2023, on August 22, 2024 the Federal Trade Commission finalized a rule that will impose monetary civil penalties false and misleading...more
In this post, the final part of our six-part series, we explore the nuances of the “teeth” of the FTC’s Final Rule on consumer reviews and testimonials—the money the FTC can recover for violations of the Final Rule....more
On August 14, 2024, the Federal Trade Commission (FTC) struck a blow against deceptive advertising by issuing its Final Trade Regulation Rule on the Use of Consumer Reviews and Testimonials. The Rule bans the creation, sale...more
The Final Trade Regulation Rule on the Use of Consumer Reviews and Testimonials was issued yesterday. It becomes effective 60 days after the rule is published in the Federal Register, which has not happened yet so no clock is...more
The long-anticipated final rule addressing substance use disorder (SUD) records at 42 C.F.R. Part 2, commonly referred to as Part 2, is here. The final rule is a joint undertaking by the U.S. Department of Health and Human...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
On February 2, 2024, the U.S. Fish and Wildlife Service (Service) published a final rule increasing civil monetary penalties for violations of several federal wildlife and natural resource protection laws (Final Rule). The...more
The Centers for Medicare and Medicaid Services (CMS) published the final rule outlining how civil monetary penalties will be calculated and imposed when Responsible Reporting Entities (RRE) fail to meet their Medicare...more
On October 11, 2023, CMS published a final rule (the Final Rule) regarding how and when CMS will impose civil monetary penalties (CMPs) for Medicare secondary payers (MSPs) that untimely report required information. The Final...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
On July 31, 2023, CMS issued its final rule updating the rates and Medicare payment policies under the Skilled Nursing Facility Prospective Payment System (SNF PPS) for FY 2024 (the Final Rule). The Final Rule also includes...more
A final rule published on July 3, 2023, empowers the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) to impose civil monetary penalties (CMP) of up to $1 million for unlawful acts of...more
On June 27, 2023, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), posted a final rule on its website that amends the civil money penalty (CMP) regulations under the Information Blocking...more
The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more
Though there has been much speculation and commentary among industry stakeholders, the Office of Inspector General (OIG) and the Office of the National Coordinator for Health Information Technology (ONC) have not yet begun...more
On July 3, 2023, OIG published its final enforcement rule (the OIG Rule) permitting imposition of civil monetary penalties (CMPs) for certain actors that engage in information blocking in violation of the information blocking...more