News & Analysis as of

Enforcement Actions Advisory Opinions

Husch Blackwell LLP

CFTC Enforcement Division Issues Framework for DOJ Criminal Referrals

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On July 9, 2025, the Commodity Futures Trading Commission (CFTC) Division of Enforcement (DOE), acting pursuant to a recent executive order (EO), issued an advisory letter outlining its new policy for referring criminally...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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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

Skadden, Arps, Slate, Meagher & Flom LLP

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more

Foley Hoag LLP - White Collar Law &...

Federal District Court Upholds HHS Advisory Opinion Blocking Fertility Assistance Program

A recent decision from the United States District Court for the District of Columbia continues to give significant deference to the U.S. Department of Health and Human Services’ (HHS) interpretation of the Anti-Kickback and...more

Sheppard Mullin Richter & Hampton LLP

CFPB to Revoke Medical Debt Collection Advisory Opinion

On April 11, the CFPB filed a joint motion in the U.S. District Court for the District of Columbia indicating its intent to revoke an advisory opinion on medical debt collection. The Bureau requested a stay of litigation...more

Hudson Cook, LLP

CFPB Bites of the Month - October 2024 - (Don't Fear) The Reaper CFPB

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In this month's article, we share some of our top "bites" for the prior and current month covered during the October 2024 webinar. ...more

Sheppard Mullin Richter & Hampton LLP

CFPB Issues Guidelines for Medical Debt Collection

On October 1, the CFPB issued an advisory opinion highlighting that debt collectors engaging in certain practices with respect to the collection of medical debts are strictly liable under the FDCPA and Regulation F....more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2023

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

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

American Conference Institute (ACI)

[Event] 5th National Forum on FARA - December 1st, National Harbor, MD

Hosted by American Conference Institute, the 5th National Forum on FARA returns for another exciting year with curated programming that will feature the most complex, high stakes FARA issues at the forefront. This event is...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | September 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for September 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act (FCA), the...more

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | July 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Davis Wright Tremaine LLP

CFTC Issues Staff Advisory Letters on DCO Regulation: Prime Brokerage Arrangements and Digital Assets

In May 2023, the Division of Clearing and Risk ("DCR") of the Commodity Futures Trading Commission ("CFTC") issued two Staff Advisory letters addressing areas of regulatory focus related to Derivatives Clearing Organizations...more

Sheppard Mullin Richter & Hampton LLP

OIG 2022 Advisory Opinions: Year in Review

The Office of Inspector General (“OIG”) within the U.S. Department of Health and Human Services (“HHS”) is responsible for detecting and preventing fraud, waste, and abuse in federal health care programs. The OIG has...more

Sheppard Mullin Richter & Hampton LLP

OIG Shines a Spotlight on Nursing Homes, Opioid Misuse, and Health Equity in the FY2022 Semiannual Report

On December 5, 2022, the Department of Health and Human Services (“HHS”), Office of Inspector General (“OIG”), released their Semiannual Report to Congress for the period beginning on April 1, 2022, and ending on September...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-17: OIG Declines to Impose Sanctions on a Health System for Forgiveness of Credit Line Note Owed by Clinic

On September 6, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-17 (Advisory Opinion), in which it declined to impose sanctions against a regional 501(c)(3) not-for-profit health care system that...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity between August 21 and September 20, 2022, including a guilty plea from a telemedicine physician who wrote prescriptions for...more

Wiley Rein LLP

Wiley Consumer Protection Download (July 12, 2022)

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Regulatory Announcements- CFPB Issues Advisory Opinion on FCRA Permissible Purposes for Providing Consumer Reports. On July 7, the CFPB issued an Advisory Opinion on the Fair Credit Reporting Act (FCRA) that outlines...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | January - April 2022

This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more

ArentFox Schiff

Physician Ownership in Medical Device Company Will Not Trigger Anti-Kickback Statute Enforcement Action, OIG Concludes in Advisory...

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Physician-owned companies that generate revenue from the sale of medical devices ordered by their physician owners have in recent years been the target of federal fraud and abuse enforcement actions. OIG Advisory Opinion...more

Wiley Rein LLP

Wiley Consumer Protection Download (May 16, 2022)

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Alvaro Bedoya Sworn in as FTC Commissioner Following Senate Confirmation. On May 16, Alvaro Bedoya was sworn in as FTC Commissioner. The U.S. Senate confirmed Bedoya to the FTC’s open Commissioner on May 11. ...more

Bass, Berry & Sims PLC

OIG Declines to Approve Lab’s Payment of Specimen Collection Fees to Hospitals

On April 28, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-09, declining to approve a laboratory company’s proposal to pay hospitals a fair market...more

Hogan Lovells

DOJ issues rare FCPA advisory opinion regarding the extortion exception

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On January 21, 2022, the Department of Justice (“DOJ”) issued a Foreign Corrupt Practices Act (“FCPA”) Opinion Procedure Release (the “OPR” or “OPR 22-01”) addressing the rarely discussed extortion exception to the FCPA’s...more

Foley Hoag LLP - Medicaid and the Law

District Courts Issue Key Decisions in 340B Contract Pharmacy Cases

Over the last two weeks we have seen a flurry of activity from U.S. District Courts across the country in the ongoing contract pharmacy disputes between pharmaceutical manufacturers and HRSA, the agency responsible for...more

Foley & Lardner LLP

Court Sides with Drug Manufacturers in Ongoing 340B Litigation

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Over the last year, covered entities participating in the 340B Drug Pricing Program (340B Program) have anxiously monitored a flurry of litigation that could determine the scope of the 340B Program. The litigation and related...more

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