News & Analysis as of

Department of Health and Human Services (HHS) Fraud Anti-Kickback Statute

Foley & Lardner LLP

Unpacking the Federal Anti-Kickback Statute’s Application to Payments to Medicare Advantage Agents and Brokers

Foley & Lardner LLP on

On December 11, 2024, the U.S. Department of Health & Human Services’ Office of Inspector General (OIG), issued a Special Fraud Alert (Alert) focusing on financial arrangements involving Medicare Advantage (MA) Organizations...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

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Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...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

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

Hendershot Cowart P.C. on

Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more

Hendershot Cowart P.C.

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

Hendershot Cowart P.C. on

Telemedicine companies are supposed to facilitate medically necessary services to beneficiaries over the telephone via licensed medical professionals. In reality, however, many of these “telemedicine companies” are...more

Foley & Lardner LLP

Health-Care Fraud Scrutiny Heats Up For Companies, Providers

Foley & Lardner LLP on

This year will see a continued proliferation of enforcement against health-care fraud, with old and new theories. Some hot spots for enforcement will involve cases about new technologies; data outliers; entities perceived as...more

Proskauer - Health Care Law Brief

OIG Reaffirms Its Concern About “Carving Out” Federal Health Care Program Business

Last month, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services reaffirmed its longstanding position that an arrangement that “carves out” Federal health care program (FHCP) business is...more

Harris Beach Murtha PLLC

Office of Inspector Warns Against Proposed Surgeon-owned Turnkey Intraoperative Neuromonitoring Business

In a rarely seen “unfavorable” advisory opinion, the United States Department of Health and Human Services Office of Inspector General (“OIG”) recently warned that an entity’s (“Requestor”) proposal to assist surgeons in...more

Harris Beach Murtha PLLC

OIG Enforcement Summary: August 1, 2022 – August 15, 2022

The following is a summary of the federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported are...more

ArentFox Schiff

OIG Warns Health Care Practitioners About Fraud Schemes With Telemedicine Companies in Special Fraud Alert

ArentFox Schiff on

On July 20, 2022, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert cautioning physicians and other health care practitioners to use “heightened scrutiny” when entering into telemedicine arrangements that...more

Goodwin

OIG Alert and DOJ Enforcement Action Summary: Telemedicine Arrangements

Goodwin on

The July 20, 2022 Special Fraud Alert describes findings from what OIG describes as “dozens of investigations of fraud schemes involving companies that purported to provide telehealth, telemedicine, or telemarketing services”...more

Miller Canfield

New Federal Anti-Fraud Guidance for Participants in the Telehealth Space

Miller Canfield on

On July 22, 2022, the Office of the Inspector General of the U.S. Department of Health and Human Services (OIG) issued a Special Fraud Alert regarding transactions between practitioners and telemedicine companies. Aware that...more

Venable LLP

HHS 2021 Semiannual Report to Congress Draws Attention to Genetic Testing, Durable Medical Equipment, and Opioid Disorder...

Venable LLP on

On June 6, 2022, the U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG), released its spring 2022 semiannual report to Congress. The semiannual report covers the period of October 1, 2021 to...more

Rivkin Radler LLP

OIG Permits Arrangement Involving Physician-Owned Medical Device Company

Rivkin Radler LLP on

In a recent Advisory Opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) determined that an arrangement involving certain physicians who have an ownership interest in a medical device...more

ArentFox Schiff

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

ArentFox Schiff on

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

Mintz - Health Care Viewpoints

OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more

King & Spalding

OIG Publishes New Procedural Process for Advisory Opinions

King & Spalding on

On January 6, 2022, OIG issued a final rule (Final Rule) that will update the process and procedures that govern advisory opinions in early 2022. The Final Rule will be effective 30 days after its publication in the Federal...more

Baker Donelson

What You Need to Know About the Updated Health Care Fraud Self-Disclosure Protocol

Baker Donelson on

As part of the Department of Health and Human Services' (HHS) ongoing evaluation of its self-disclosure process, the Office of the Inspector General (OIG) recently issued an update to the newly renamed Healthcare Fraud...more

Saul Ewing LLP

HHS OIG Releases Updated Health Care Fraud Self-Disclosure Protocol

Saul Ewing LLP on

On November 8, 2021, the United States Department of Health and Human Services (HHS) Office of Inspector General (OIG) released an updated Self-Disclosure Protocol (SDP) (here). The revision of the SDP is an important...more

ArentFox Schiff

Drug Manufacturers Take Note: Updated PhRMA Code Released

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The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals”...more

Mintz - Health Care Viewpoints

PhRMA Updates its Code on Interactions with Health Care Professionals in Response to the OIG's Special Fraud Alert on Speaker...

On Friday, August 6, 2021, Pharmaceutical Research and Manufacturers of America (PhRMA), the preeminent trade association representing pharmaceutical companies, announced revisions to its Code on Interactions with Health Care...more

Holland & Knight LLP

Healthcare Law Update: April 2021

Holland & Knight LLP on

William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Holland & Knight LLP

Healthcare Law Update: February 2021

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To date, there has been little consistency in how Health Insurance Portability and Accountability Act (HIPAA) requirements are enforced by the U.S. Department of Health and Human Services (HHS), or the amount of settlements...more

Bradley Arant Boult Cummings LLP

False Claims Act 2020 Year in Review

This year saw substantial activity in FCA settlements and litigated court cases. Although no single case or development dominated the discourse this year, several important court decisions were issued, including two that may...more

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