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Enforcement Actions Advisory Opinions

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 & Emery

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 & Emery

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 & Emery

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 & Emery

Healthcare Regulatory Check-Up Newsletter | September 2022 Recap

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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

Dechert LLP

Dechert Cyber Bits - Issue 21

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US Federal Appellate Court Issues Opinion on Proof of Injury in Data Breach Cases - On September 2, 2022, the U.S. Court of Appeals for the Third Circuit reinstated a class action lawsuit that had previously been dismissed...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 & Emery

Healthcare Regulatory Check-Up Newsletter | January - April 2022

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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

Sheppard Mullin Richter & Hampton LLP

Contract Pharmacies and the 340B Drug Discount Program: New Litigation and an Advisory Opinion Point to Ongoing Skirmishes on the...

On December 11, 2020, five hospital groups, including the American Hospital Association (“AHA”), and an organization of hospital pharmacists representing participants in the 340B drug pricing program (“340B Program”), filed a...more

Goodwin

SEC Finalizes Reforms Under Investment Advisers Act

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In this Issue. The Securities and Exchange Commission (SEC) finalized reforms under the Investment Advisers Act to modernize rules that govern investment adviser advertisements and payments to solicitors, and published a risk...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Ballard Spahr LLP

CFPB finalizes advisory opinions policy and issues two advisory opinions

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The CFPB has issued its final Advisory Opinions Policy, which allows stakeholders to request interpretive guidance “to resolve regulatory uncertainty.” While advisory opinions (AO) may address uncertainty in both statutes...more

Womble Bond Dickinson

CFPB Issues Advisory Opinion on Earned Wage Access Programs

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CFPB issued an advisory opinion on Earned Wage Access (EWA) on Monday afternoon. We’ve written about earned wage access products before as well as state legislative initiatives to regulate them. The new federal guidance...more

A&O Shearman

DOJ Issues FCPA Opinion Procedure Approving Legitimate Payments To Government Instrumentalities

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On August 14, 2020, the U.S. Department of Justice (“DOJ”) released its first Foreign Corrupt Practices Act (“FCPA”) Opinion (the “August 14 Opinion”) in six years, in response to a request from a multinational company...more

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