News & Analysis as of

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

Fraud is the making of false representations or engaging in deceptive behavior in order to unlawfully secure financial or personal gain. 
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 PLLC

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

Harris Beach PLLC on

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 PLLC

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

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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

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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

Holland & Knight LLP on

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

ArentFox Schiff

Investigations Newsletter: HHS Announces Formation of FCA Working Group

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HHS Announces Formation of FCA Working Group - On December 4, 2020, the US Department of Health and Human Services (HHS) announced that it is creating a False Claims Act Working Group to enhance the partnership between...more

Saul Ewing LLP

HHS Issues Special Fraud Alert Regarding Risks of Promotional Speaker Programs

Saul Ewing LLP on

On November 16, 2020, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”), issued a Special Fraud Alert highlighting the Anti-Kickback Statute (“AKS”) risks for pharmaceutical...more

ArentFox Schiff

Investigations Newsletter: HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute

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HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute - On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services (HHS) published...more

K&L Gates LLP

HHS OIG Highlights "Inherent Fraud and Abuse Risks" of Company-Sponsored Speaker Programs in Rare Special Fraud Alert

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Lavish “speaker programs” sponsored by pharmaceutical and medical-device companies may soon be a thing of the past—and not just because of the COVID-19 pandemic. In a 16 November 2020 Special Fraud Alert (Alert) issued by the...more

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