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
The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more
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
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
UCHealth Settles FCA Violations for $23 Million - On November 12, the US Department of Justice (DOJ) announced that University of Colorado Health (UCHealth) agreed to resolve allegations that it violated the False Claims...more
The health care industry is anxiously awaiting the First Circuit’s ruling on the standard of causation for actions brought under the False Claims Act (FCA) predicated on a federal Anti-Kickback Statute (AKS) violation. The...more
Last week, the Eleventh Circuit held that a conspiracy need not be unlawful to introduce co-conspirator statements under Federal Rule of Evidence 801(d)(2)(E), reversing the district court’s exclusion of certain statements....more
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
Walgreens Settles for $106.8 Million Over FCA Violations - On September 13, the US Department of Justice (DOJ) announced that Walgreens Boots Alliance Inc. and Walgreen Co. (collectively, Walgreens) agreed to pay $106.8...more
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
On July 8, 2024, OIG updated the Frequently Asked Questions on its website, adding four new questions and answers to its General Questions Regarding Certain Fraud and Abuse Authorities...more
On June 28, 2024, the Supreme Court overruled Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., and consequently invalidated the “Chevron Deference” — a cornerstone of administrative law since 1984. In the 6-3 decision...more
On June 28, 2024, the Supreme Court rejected the doctrine of Chevron deference in the closely watched case of Loper Bright Enterprises v. Raimondo. In a 6-3 decision, the Court held that Chevron’s rule that courts must defer...more
Teva and DOJ May Reach Settlement in Closely Watched AKS Lawsuit - On June 16, Teva Pharmaceuticals filed a request with the First Circuit Court of Appeals seeking to hold in abeyance its interlocutory appeal concerning...more
Senate Finance Health Subcommittee Holds Roundtable on Substance Use Disorder Care. Panelists and members discussed how to improve treatment in federal health programs. House Energy & Commerce Health Subcommittee Holds...more
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
On December 21, 2023, the OIG issued a favorable advisory opinion (Advisory Opinion 23-11) regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial. The...more
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
Community Health Network, Inc., based in Indianapolis, Indiana, has paid $345 million to settle alleged violations of the False Claims Act (FCA). The lawsuit was initiated through a whistleblower complaint that was filed in...more
The Department of Health and Human Services’ Office of Inspector General (OIG) published a General Compliance Program Guidance (GCPG) on November 6, 2023, marking the first update to OIG’s compliance program guidance...more
The Centers for Medicare and Medicaid Services’ (CMS) new program Making Care Primary (MCP), is anticipated to begin July 1, 2024. In a previous blog post Foley breaks down major highlights of the new model. On...more
Medical Marketer Convicted of $55 Million Fraud Scheme - Late last week, a federal jury in the Northern District of Texas convicted Quintan Cockerell for his role in a $55 million fraud conspiracy involving TRICARE, a...more
On October 20, 2023, OIG issued a negative Advisory Opinion in response to a proposal from a cochlear implant manufacturer (Requestor) to offer and provide free compatible hearing aids to certain patients (Proposed...more
Earlier this month, OIG issued Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the...more
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