Consumer Finance Monitor Podcast Episode: Navigating the Consumer Financial Protection Bureau’s Proposed Personal Financial Data Rule
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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 April 8, 2024, the Department of Health and Human Services Office of Inspector General (OIG) issued a long-awaited favorable Advisory Opinion (AO 24-02) for a charitable patient assistance program (PAP) focused on rare...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 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
Patient assistance programs (PAPs) that seek to subsidize patient co-payments for drugs covered by Medicare may involve compliance challenges. A recent U.S. Department of Health and Human Services (HHS) Office of Inspector...more
On October 5, 2022, OIG posted Advisory Opinion 22-19 in response to a nonprofit corporation’s (Requestor) request to analyze a proposal for certain pharmaceutical companies (each, the Funding Manufacturer) to subsidize: 1)...more
On October 5, 2022, the Office of Inspector General (“OIG”) posted Advisory Opinion No. 22-19 (the “Opinion”), which limits the ability of pharmaceutical manufacturers to offer cost-sharing subsidies to Medicare Part D (“Part...more
On October 5, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion No. 22-19, finding that a proposal by an entity funded entirely by manufacturers of oncology...more
On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay...more
On Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. 22-05, relating to subsidization of certain Medicare cost-sharing...more
On February 4, 2022, OIG issued Advisory Opinion No. 22-02 in which it responded to a request for an advisory opinion submitted by a hospital system that operates a children’s hospital (Requestor) regarding a proposed...more
On September 18, 2020, OIG issued Advisory Opinion No. 20-05 analyzing a pharmaceutical manufacturer’s proposal to offer direct cost-sharing assistance to Medicare beneficiaries prescribed certain of the manufacturer’s new...more
On September 18, 2020, the Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable Advisory Opinion, No. 20-05 (the Opinion), that a pharmaceutical manufacturer’s (Requestor) proposed...more
On January 9, in its first Advisory Opinion of 2019 (OIG Advisory Opinion 19-01), the U.S. Department of Health and Human Services, Office of the Inspector General (OIG), issued a favorable opinion regarding an arrangement...more
In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts. The OIG’s analysis hinged on several factors that, taken...more
On January 14, 2019, the Health and Human Services Office of Inspector General (OIG) published a favorable Advisory Opinion allowing a charitable pediatric clinic (Clinic) to routinely waive cost-sharing amounts for patients...more
A group of six government-operated fire departments has received a green light from the Office of Inspector General (OIG) to enter into a mutual aid agreement to provide backup emergency ambulance services and to bill for...more
In Advisory Opinion No. 18-07, issued July 30, 2018, the OIG permitted a group purchasing organization (GPO) to serve health care facilities owned by the same parent organization as the GPO. While acknowledging that the...more
With Advisory Opinion 18-06, issued July 11, 2018, the OIG added to the ever-growing number of favorable advisory opinions addressing an agreement between a Medicare Supplemental Health Insurance (Medigap) insurer and a...more
A non-profit acute care hospital may share cost savings for certain spinal surgeries with neurosurgeons in a multi-specialty physician group following approval by the U.S. Department of Health & Human Services, Office of...more
On Jan. 4, 2018, the HHS Office of Inspector General (OIG) issued an open letter containing guidance regarding the provision of certain free drugs to federal healthcare program beneficiaries. Specifically, the OIG stated that...more
With Advisory Opinion 17-04, issued August 24, 2017, the U.S. Department of Health and Human Services, Office of Inspector General (OIG) adds to the ever-growing number of favorable advisory opinions regarding an agreement...more
The Office of Inspector General (OIG) recently issued Advisory Opinion 17-02, allowing waivers or reductions of cost-sharing amounts owed by financially needy Medicare beneficiaries in connection with certain clinical...more
On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule creating additional “safe harbors” for the Federal Anti-Kickback Statute (42 USC § 1320a-7b(b) et...more
On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more