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Insights & Resources

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  • Audience: Clinical Research Organizations
Alerts

OIG Allows Patient Assistance Programs Funded by Drug Manufacturers

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-02) permitting a non-profit organization (Non-Profit) to provide financial support to eligible patients with specific rare diseases through assistance programs (Programs) it operates.
Alerts

OIG Issues New Resource for Single Audits

The United States Department of Health and Human Services (HHS), Office of Inspector General (OIG) recently posted a new educational resource on its website about Single Audits.  HHS is the largest grant-making agency in the Federal government, and OIG’s new resource is designed to help key stakeholders understand the scope of Single Audits, as well as improve the overall quality of such audits.
Alerts

Favorable OIG Advisory Opinion Allows Subsidies for FDA-Approved Clinical Studies

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-11) that allows a medical device manufacturer (Manufacturer) to subsidize Medicare cost-sharing obligations as part of a U.S. Food & Drug Administration (FDA)-approved clinical study involving a Category B Investigational Device Exemption.  
Alerts

OIG Approves Creative Approach to Restructuring Medical Practice Partnerships

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-12) that allows a limited liability partnership (the Partnership) consisting of two classes of physician partners to make a one-time, voluntary redemption offer (offer) to individual partners when they reach age 67.  
Alerts

OIG Approves Use of Gift Cards for Referrals in Certification-Heavy Advisory Opinion

The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (23-15) permitting a consulting company’s (Consultant) proposal to offer gift cards to its current physician practice customers for referring potential new physician practice customers to Consultant.  Notably, OIG determined that the proposed arrangement did not implicate the Anti-Kickback Statute (AKS). 
Alerts

OMIG’s 2024 Work Plan Gives Critical Insights into Program Integrity Initiatives

The New York State Office of the Medicaid Inspector General (OMIG) released its 2024 work plan in furtherance of its mission to coordinate and conduct activities to prevent, detect and investigate medical assistance program fraud, waste and abuse, and to recover improperly expended Medicaid funds.  
Alerts

More Provider “Nuggets” From OIG’s Year-End Reporting Blitz

Continuing its year-end reporting blitz, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Semiannual Report (SAR) to Congress on December 1, 2023. 
Alerts

DOJ/HHS Jointly Release "Highlight Reel" Report

This week, the United States Department of Justice (DOJ) and the United States Department of Health and Human Services (HHS) fulfilled its annual statutory obligation by releasing its jointly-authored Health Care Fraud and Abuse Control Program (HCFAC) Report for Fiscal Year 2022.
Alerts

OIG Provides Roadmap to Hot-Button Issues

The OIG fulfilled its annual statutory obligation by releasing its Top Management and Performance Challenges (TMC) document. Providers should take note because the document provides important insight into the specific areas over which HHS (and the OIG) will remain focused.  
Alerts

OIG Releases New General Compliance Program Reference Guide

On November 6, 2023, the OIG released its General Compliance Program Guidance, the first in a series of new, non-binding reference guides designed to share information with health care compliance professionals and other health care industry stakeholders
Alerts

Temporary Health Care Staffing Agencies Now Required to Register in New York

In what appears to follow a multi-state trend to protect “temporary” workers, as part of the New York Budget for FY 2023-2024, a new law went into effect that requires any entity that provides temporary staff to health care entities to register with the Department of Health (DOH). 
Events

Garfunkel Wild Webinar – An Employer’s Practical Guide To Facing Day-To-Day Coronavirus Challenges

Garfunkel Wild’s Andrew Zwerling, Marianne Monroy, Salvatore Puccio, and Lauren Levine will present the webinar  “An Employer’s Practical Guide To Facing Day-To-Day Coronavirus Challenges” on April 20, 2020.
Events

Garfunkel Wild Webinar – Navigating A Murky Landscape: An Employer’s Guide To Responding To The Challenges of COVID-19

Garfunkel Wild’s Andrew Zwerling, Marianne Monroy, Salvatore Puccio, and Lauren Levine will present the webinar  Navigating A Murky Landscape: An Employer’s Guide To Responding To The Challenges of COVID-19” on March 30, 2020.
Events

Greater New York Hospital Association (GNYHA) Webinar – Clinical Trial Agreements

Lara Jean Ancona will present at the Greater New York Hospital Association’s (GNYHA) Webinar – Clinical Trial Agreements on January 15, 2020.
Events

Nassau County Bar Association (NCBA) Hospital and Health Law Committee CLE – Recent Trends in Health Care Fraud Investigations

John G. Martin and Robert A. Del Giorno will present at the Nassau County Bar Association’s CLE – Recent Trends in Health Care Fraud Investigations on September 17, 2019.
Events

Fairfield County Medical Association’s (FCMA) Webinar – Navigating Sexual Harassment in the Workplace for Managers and Supervisors

Marianne Monroy and Salvatore Puccio will present at the FCMA’s Webinar – Navigating Sexual Harassment in the Workplace for Managers & Supervisors on May 9, 2019.
Events

Hudson Valley Annual Institute 2019

Andrew l. Zwerling, Marianne Monroy and Salvatore Puccio will present at the Hudson Valley Annual Institute on April 4, 2019.