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- Audience: Emerging Companies
Alerts
OIG Approves Drug Refund and Discount Program
The OIG's trend of ensuring access to care in compelling circumstances continued with a recent opinion allowing a pharmaceutical affiliate to refund, waive, or delay payment for a drug treating a rare, fatal pediatric immunodeficiency disorder.
Alerts
OIG Greenlights Gene Therapy Assistance Program
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted a favorable Advisory Opinion (24-03) permitting a pharmaceutical manufacturer (Manufacturer) to provide financial assistance to qualified patients undergoing its gene therapy treatment for two severe genetic conditions.
Alerts
OIG Report Highlights Enforcement Priorities
The U.S. Department of Health and Human Services (HHS), Office of Inspector General (OIG) released its revamped Semiannual Report (SAR) on June 3, 2024. The SAR’s new format focuses on the oversight work OIG completed during the reporting period, and emphasizes how this work directly addresses the Top Management Challenges Facing HHS.
Alerts
Telehealth Update: NY Proposes Controlled Substance Prescribing, Waiting on DEA
On May 15, 2024, the New York State Department of Health (DOH) announced a pivotal change in its regulations, as it intends to permit health care providers to use telemedicine to conduct patient evaluations before prescribing controlled substances. Prior to the COVID-19 pandemic, DOH required health care providers to perform an initial in-person physical evaluation of patients before prescribing controlled substances.
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 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
OIG’s Favorable Advisory Opinions Allow Incentives to Medigap Plan Policyholders
The U.S. Department of Health and Human Services, Office of Inspector General (OIG) posted two favorable Advisory Opinions (23-09 and 23-10) to allow a licensed offeror of Medicare Supplemental Health Insurance (Medigap Plan) policies and a preferred health organization (PHO) (collectively, “the requestors”) to incentivize Medigap Plan policyholders to seek inpatient care from a hospital within the PHO’s network. Notably, OIG issued these favorable opinions even though the proposed incentives implicated the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Civil Money Penalty (CMP), and there was no applicable exception or safe harbor.
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 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).