News & Analysis as of

Reimbursements Anti-Kickback Statute

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

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - June 9th - 12th, Pittsburgh, PA

Ideal for practitioners who want to build strong foundational knowledge of compliance program management in a healthcare setting and how to apply that knowledge in practice. Attendees will come away better prepared to...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - March 24th - 27th, Chicago, IL

Ideal for practitioners who want to build strong foundational knowledge of compliance program management in a healthcare setting and how to apply that knowledge in practice. Attendees will come away better prepared to...more

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

King & Spalding on

On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - January 27th - 30th, Orlando, FL

Ideal for practitioners who want to build strong foundational knowledge of compliance program management in a healthcare setting and how to apply that knowledge in practice. Attendees will come away better prepared to...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

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - December 9th - 12th, San Diego, CA

Ideal for practitioners who want to build strong foundational knowledge of compliance program management in a healthcare setting and how to apply that knowledge in practice. Attendees will come away better prepared to...more

ArentFox Schiff

Investigations Newsletter: Federal Court Permits Investors to Resume Kickback Suit Against Teva

ArentFox Schiff on

Federal Court Permits Investors to Resume Kickback Suit Against Teva - After a two-year long stay, on August 30, Judge Karen S. Marston of the US District Court for the Eastern District of Pennsylvania ruled that investors...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - November 18th - 21st, Boston, MA

Ideal for practitioners who want to build strong foundational knowledge of compliance program management in a healthcare setting and how to apply that knowledge in practice. Attendees will come away better prepared to...more

ArentFox Schiff

Investigations Newsletter: Precision Lens Pays $12 Million to Resolve FCA and AKS Violations

ArentFox Schiff on

Precision Lens Pays $12 Million to Resolve FCA and AKS Violations - Late last week, Precision Lens and the estate of its former principal agreed to pay $12 million to resolve allegations regarding violations of the False...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - August 19th - 22nd, Washington, DC

This three-and-a-half-day, classroom-style learning experience is designed for compliance professionals ready to advance their career by mastering the fundamentals of compliance program management in a healthcare setting....more

Proskauer - Health Care Law Brief

Recent Circuit Litigation Continues to Highlight “But-For” Causation Requirement for the Government to Demonstrate an FCA...

In recent years, a circuit split among the United States Courts of Appeals has emerged over how courts have interpreted the False Claims Act’s (“FCA”) causation element in cases where a violation of the Anti-Kickback Statute...more

Health Care Compliance Association (HCCA)

[Event] Basic Healthcare Compliance Academy - July 15th - 18th, Charlotte, NC

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Farrell Fritz, P.C.

Second Circuit Defines “Willfulness” Standard Under Anti-Kickback Statute

Farrell Fritz, P.C. on

Recently, in United States ex rel. Hart v. McKesson Corp., the Second Circuit clarified the standard for acting “willfully” under the federal anti-kickback statute (AKS). False Claims Act relator Adam Hart alleged that...more

Foley & Lardner LLP

Health-Related Social Needs: Three Trends in Leveraging Community Partnerships

Foley & Lardner LLP on

Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 15th - 18th, Charlotte, NC

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - June 3rd - 6th, New Orleans, LA

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Holland & Hart LLP

Patient Inducements: Law and Limits

Holland & Hart LLP on

Although often well-intentioned, offering free or discounted items or services to patients (e.g., gifts, rewards, writing off copays, free screening exams, free supplies, etc.) may violate federal and state laws governing...more

ArentFox Schiff

Investigations Newsletter: DC Federal Judge Dramatically Amplifies False Claims Act Damages Award

ArentFox Schiff on

DC Federal Judge Dramatically Amplifies False Claims Act Damages Award - On January 16, Judge Rudolph Contreras of the US District Court for the District of Columbia issued an opinion agreeing in part with the federal...more

Mintz - Health Care Viewpoints

OIG Issues a Favorable Advisory Opinion on Vendor’s Offer of Gift Cards to Physician Practices for Recommending the Vendor’s...

The Office of Inspector General (OIG) started 2024 with a flurry of activity by issuing four new Advisory Opinions on January 3, 2024. In one of these Advisory Opinions, the OIG approved a vendor’s referral program that...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - March 11th - 14th, Nashville, TN

Designed for professionals with some compliance knowledge and experience, HCCA’s Healthcare Basic Compliance Academy is ideal for practitioners who are ready to support, enhance, and oversee a comprehensive compliance program...more

Mintz - Health Care Viewpoints

OIG Issues Unfavorable Advisory Opinion on Free Items to Patients Tied to Reimbursable Services

Perhaps unsurprisingly, the Office of Inspector General for the Department of Health and Human Services (OIG) rejected a manufacturer’s proposal to provide free hearing aids to certain patients if they receive one of the...more

Harris Beach Murtha PLLC

OIG Kickback Opinion: Referring Labs Providing Technical Component Services Implicate Anti-Kickback Statute

Harris Beach Murtha PLLC on

This opinion addresses a proposed agreement (“Proposed Arrangement”) between a national anatomic pathology laboratory (“Requestor”) and laboratories owned in whole or in part by physicians who may refer (“Referring...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - February 26th - 29th, Phoenix, AZ

This three-and-a-half-day, classroom-style learning experience is designed for compliance professionals ready to advance their career by mastering the fundamentals of compliance program management in a healthcare setting....more

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