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Advisory Opinions Compliance

ArentFox Schiff

Understanding OIG Advisory Opinion 25-09: Compliance Guidelines for Physician-Owned Medical Device Companies

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On August 7, the US Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-09, providing significant guidance for physician-owned medical device companies (PODs)....more

ArentFox Schiff

Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks

ArentFox Schiff on

On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device...more

Husch Blackwell LLP

CFTC Enforcement Division Issues Framework for DOJ Criminal Referrals

Husch Blackwell LLP on

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

Epstein Becker & Green

New OIG Advisory Opinion Approves Manufacturer’s Warranty for Injuries Caused by Medical Device

Epstein Becker & Green on

On June 30, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services posted Advisory Opinion 25-05 (AO 25-05) to its website....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

ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

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On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

DLA Piper

OIG Issues Favorable Advisory Opinion on Telehealth Marketplace MSO-PC Arrangement

DLA Piper on

The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more

Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

Gardner Law on

Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

Mintz - Health Care Viewpoints

OIG Issues Another Favorable Advisory Opinion on Patient Recruitment Efforts by Community Health Centers

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more

Baker Donelson

Relocation of Physician-Owned Hospitals: CMS Advisory Insights

Baker Donelson on

The Centers for Medicare and Medicaid Services (CMS) issued CMS Advisory Opinion No. CMS-AO-2025-1 on February 26, 2025, blessing the relocation of a physician-owned hospital. The hospital planned to relocate eight miles from...more

King & Spalding

DOJ Issues Final Rule Restricting Foreign Access to U.S. Data

King & Spalding on

The rule imposes substantial new diligence, reporting, cybersecurity, and auditing obligations on companies. On December 27, 2024, the U.S. Department of Justice (“DOJ”) issued a final rule implementing Executive Order...more

Hinch Newman LLP

DOJ Issues Rule Addressing Threat Posed by Foreign Adversaries’ Access to Americans’ Sensitive Personal Data

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On Friday, December 27, 2024, the Justice Department issued a final rule to address “urgent national security risks posed by access to U.S. sensitive personal and government-related data from countries of concern and covered...more

BakerHostetler

CFTC Issues Advisory Related to Use of Artificial Intelligence

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In issuing the Advisory, the CFTC recognizes the potential for AI to transform the U.S. financial markets. However, given how far-reaching AI’s impact may be, the CFTC simultaneously cautions CFTC-regulated entities to be...more

ArentFox Schiff

FCA Enforcement & Compliance Digest — Fall 2024 False Claims Act Newsletter

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Welcome to the Fall 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and compliance...more

Proskauer - Health Care Law Brief

Arrangements Involving Intraoperative Neuromonitoring Continue to be Scrutinized under the Federal Anti-Kickback Statute

This week, the U.S. Attorney’s Office for the District of Colorado (“USAO”) announced that it entered into a series of interrelated settlement agreements with companies that provide intraoperative neuromonitoring (“IONM”)...more

Gardner Law

OIG’s Perspective on Discount and Refund Programs

Gardner Law on

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

King & Spalding

Biden Administration Issues Proposed Rule Targeting “Connected Vehicles” Tied to China or Russia

King & Spalding on

The Proposed Rule imposes substantial new reporting, diligence, and compliance obligations for companies in the automotive supply chain - On September 26, 2024, the U.S. Department of Commerce’s Bureau of Industry and...more

Holtzman Vogel Baran Torchinsky & Josefiak

In Compliance - Holtzman Vogel's September 2024 Round-Up

FEC Advisory Opinion Approves Federal Candidate Request to Add Super PAC to Joint Fundraising Committee - In Advisory Opinion 2024-07, the FEC approved a request made by Team Graham, the principal campaign committee of...more

Holtzman Vogel Baran Torchinsky & Josefiak

In Compliance: Holtzman Vogel's July 2024 Round-Up

Holtzman Vogel attorneys wrote on the Supreme Court's landmark Loper Bright decision earlier this month. The Court overruled its 1984 decision in Chevron v. NRDC that introduced the so-called "Chevron deference" principle...more

Holtzman Vogel Baran Torchinsky & Josefiak

In Compliance: Holtzman Vogel's May 2024 Round-Up

At the FEC’s May 1 open meeting, the Commission voted 4-1 to approve an advisory opinion requested by Nevadans for Reproductive Freedom (“NFRF”) that authorizes federal candidates and officeholders to solicit unlimited funds,...more

Bradley Arant Boult Cummings LLP

Fannie Mae Issues Fair Servicing Best Practices Guide

This week, in line with the CFPB’s ever-increasing focus on fair lending, Fannie Mae issued a Fair Servicing Best Practices Guide to promote “servicer awareness of fair servicing best practices.” Taking a big picture...more

Holland & Knight LLP

Court Upholds OIG Advisory Opinion Shooting Down a Patient Assistance Program

Holland & Knight LLP on

Healthcare compliance risks exist even when a company takes steps to structure its business activities to follow the government's own statements. A recent decision by the U.S. District Court for the Eastern District of...more

Foley & Lardner LLP

HHS OIG: New “General Compliance Program Guidance” Provides Voluntary Steps Towards Increased Effectiveness

Foley & Lardner LLP on

In connection with the November 2023 Health Care Compliance Association’s (HCCA) Healthcare Enforcement Compliance Conference, and with acknowledgment by the Chief Counsel to the Inspector General, Rob DeConti, of the long...more

McDermott Will & Schulte

HHS-OIG Invites Participation in Modernization Initiative: RFI Comment Deadline Approaching

On September 24, 2021, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a request for information (RFI) to advance its guidance modernization initiative. The RFI seeks industry...more

WilmerHale

OFAC Imposes New Sanctions to Thwart Ransomware

WilmerHale on

On September 21, 2021, the US Treasury Department’s Office of Foreign Assets Control (“OFAC”) levied its first sanctions against a Russian-operated virtual currency exchange involved in ransomware payments and published an...more

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