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CFPB Advisory Opinion on Name-Only Matching Under FCRA - The Consumer Finance Podcast
FCPA Compliance and Ethics Report-Episode 121-FCPA Year in Review, Part II
On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 25-03 (Opinion), which provided favorable guidance for physician practices seeking to contract with...more
On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more
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
The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more
On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management...more
On April 9, 2025, OIG posted Advisory Opinion No. 25-02, a favorable advisory opinion allowing a community health center operating under Section 330 of the Public Health Service Act (the Requestor) to ask individuals, to whom...more
On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more
On September 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 24-08, in which it declined to approve a proposal by a Medicare Advantage organization (MAO)...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for July 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including a final rule on provider...more
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
The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...more
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
Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more
On December 28, 2023, the Office of Inspector General (the “OIG”) issued a favorable Advisory Opinion (No. 23-15) (the “Opinion”) to a consulting vendor (the “Requestor”) that wanted to provide up to $75 in gift cards to...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
This favorable OIG opinion concludes that although the proposed arrangement (“Proposed Arrangement”) to subsidize Medicare cost-sharing obligations for Medicare patients in a cardiac clinical trial (“Study”) would constitute...more
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
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
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
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
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
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
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
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
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