News & Analysis as of November 17, 2024

Office of the Inspector General

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Investigations Newsletter: Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional

ArentFox Schiff on 10/7/2024

Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional - On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more

Health Care Enforcement: “Tea Leaves” in the 2024 National Health Care Fraud Summer Takedown

Foley & Lardner LLP on 8/29/2024

Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more

FMV for Provider Contracts: Regulatory Standards

Holland & Hart LLP on 8/22/2024

As a general rule, healthcare employers are required to pay employed physicians and other contracted providers fair market value (FMV) for their services, but many employers do not understand relevant regulatory standards. ...more

OIG Advisory Opinion 24-03 Greenlights Travel and Lodging Assistance for Gene Therapy Patients

Bass, Berry & Sims PLC on 6/28/2024

On June 17, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 24-03, approving an arrangement under which a pharmaceutical manufacturer provides travel, lodging, and...more

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

Foley & Lardner LLP on 3/28/2024

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

Doctors: Don’t Fall Victim To Telemedicine Fraud Schemes

Hendershot Cowart P.C. on 3/11/2024

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

OIG Opines on Subsidizing Medicare Cost-Sharing for Clinical Trials

Foley & Lardner LLP on 2/27/2024

In a recent Advisory Opinion No. 23-11 (Advisory Opinion), the Office of Inspector General (OIG) opined that it will not impose administrative sanctions against a clinical trial sponsor covering up to $2,000 of a clinical...more

Healthcare Regulatory Check-Up Newsletter | January 2024 Recap

McDermott Will & Emery on 2/26/2024

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the new Innovation in...more

HHS Office of Inspector General November 2023 Enforcement Activity

Harris Beach PLLC on 12/8/2023

The following is a summary of selected 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...more

OIG Issues New Advisory Opinion on Federal Anti-Kickback Statute

WilmerHale on 11/14/2023

The Department of Health and Human Services Office of Inspector General (OIG) recently issued an advisory opinion that explored the limits of a relatively new safe harbor to the federal Anti-Kickback Statute (AKS) that aims...more

Déjà vu? OIG Reiterates Concerns about Providing Free Items or Services to Federal Healthcare Program Beneficiaries

Bass, Berry & Sims PLC on 11/13/2023

On October 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 23-08, in which it refused to approve a proposal by a manufacturer and distributor of hearing...more

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on 11/3/2023

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

OIG Looks at How Employed Physicians Bonuses Are Paid from ASC Profits

Holland & Knight LLP on 10/23/2023

The U.S. Department of Health & Human Services Office of the Inspector General (OIG) on Oct. 13, 2023, posted Advisory Opinion No. 23-07 detailing a favorable response to a proposal by a Requestor to pay bonuses to its...more

OIG’s Favorable Opinion: Employed Physicians Paid Bonuses Based on ASCs’ Net Profits

Harris Beach PLLC on 10/19/2023

This opinion addresses a proposed arrangement (“Proposed Arrangement”) between a multi-specialty physician practice (“Requestor”) that employs approximately 11 physician employees (“Physician Employees”). In addition to base...more

OIG Issues Unfavorable Advisory Opinion on Common Arrangements between Physician Practices and Health Care Providers

Mintz - Health Care Viewpoints on 8/24/2023

On August 15, 2023, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a negative Advisory Opinion regarding a turnkey physician-owned entity (Newco) operated by an existing provider...more

OIG Advisory Opinion Warns on IONM Company “Surgeon Deals”

Rivkin Radler LLP on 8/23/2023

On August 18, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published an Advisory Opinion warning that a common arrangement under which surgeons profit from referrals of their patients...more

OIG Again Concludes That Online Health Care Provider Marketplace Does Not Violate Fraud and Abuse Laws

ArentFox Schiff on 8/15/2023

In Advisory Opinion No. 23-04, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) analyzed certain proposed changes to the functionality of a health care technology company’s online...more

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Health Care Compliance Association (HCCA) on 8/8/2023

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

False Claims Act 2023: What Every Health Care Entity Working with the Government Needs to Know

Manatt, Phelps & Phillips, LLP on 7/26/2023

In our July 18, 2023, webinar titled “False Claims Act 2023: What Every Health Care Entity Working with the Government Needs to Know,” Manatt posed the following hypothetical and asked three questions about it in our live...more

New OIG Opinion Permits Gift Cards to Beneficiaries in Limited Circumstances

Sheppard Mullin Richter & Hampton LLP on 5/12/2023

On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain...more

Sixth Circuit Defines False Claims Standards

Dickinson Wright on 4/10/2023

The Federal False Claims Act (“FCA”) imposes civil liability for presenting a false claim to the government for payment. The Federal Anti-Kickback Statue (“AKS”) prohibits medical providers from making referrals in return for...more

OIG Posts New FAQ and Advisory Opinion Addressing Cash, Cash Equivalents, and Gift Cards

Epstein Becker & Green on 4/10/2023

The Department of Health and Human Services Office of Inspector General (OIG) recently published a new frequently asked question (FAQ) and advisory opinion addressing how to analyze arrangements that may involve providing...more

OIG Issues Favorable Advisory Opinion on Gift Cards to Incentivize Patients to Return Samples for At-Home Colorectal Cancer...

Mintz - Health Care Viewpoints on 4/6/2023

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued yet another favorable Advisory Opinion on the use of gift cards to motivate patients to receive medically necessary or...more

OIG Issues Favorable Opinion Regarding Pharmaceutical Company’s Free 14-Day Drug Supply to Patients Experiencing a Delay in...

King & Spalding on 3/10/2023

On February 28, 2023, OIG posted Advisory Opinion 23-02, responding to a request by a pharmaceutical company (the Company) regarding its proposal to offer a free 14-day supply of an enzyme replacement therapy drug to patients...more

EnforceMintz — 2022 Saw the Expansion of EKRA Outside of the Addiction Treatment Setting

Mintz - Health Care Viewpoints on 2/13/2023

The Eliminating Kickbacks in Recovery Act of 2018 (EKRA) is a criminal statute that prohibits paying or receiving anything of value in exchange for the referral of patients to recovery homes, clinical treatment facilities, or...more

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