Lisa Churvis on Department of Health and Human Services (HHS)

OIG Approves Pharmaceutical Manufacturer’s Proposed Travel-Related Subsidies

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-13 (the “Opinion”) to a pharmaceutical manufacturer (the...more

1/24/2025 / Anti-Kickback Statute , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Healthcare Fraud , Manufacturers , Medicaid , Medicare , OIG , Pharmaceutical Industry , Physicians , Travel Expenses

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...more

1/17/2025 / Anti-Kickback Statute , Civil Monetary Penalty , Compliance , Department of Health and Human Services (HHS) , Genetic Testing , Healthcare Fraud , Medicare , OIG , Pharmaceutical Industry , Regulatory Requirements

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Vaccination Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-11 (the “Opinion”), to a pharmaceutical manufacturer (the...more

1/9/2025 / Anti-Kickback Statute , Compliance , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Healthcare Fraud , Manufacturers , Pharmaceutical Industry , Regulatory Requirements , Risk Management , Vaccinations

Pandemic-Era Telehealth Flexibilities Currently on Life Support

Medicare coverage of telehealth services is reaching a critical point as many pandemic-era flexibilities are set to expire on December 31, 2024. As it stands, after the close of the year, Medicare coverage for telehealth...more

11/21/2024 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Health Care Providers , Health Insurance , Medical Reimbursement , Medicare , Telehealth , Telemedicine

OIG Issues Unfavorable Opinion on MAO’s Proposed Gainshare Program

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released an unfavorable advisory opinion, OIG Advisory Opinion No. 24-08 (the “Opinion”), to a Medicare Advantage Organization (“MAO”)....more

10/3/2024 / Anti-Kickback Statute , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Healthcare , Medicare , Medicare Advantage , Medicare Advantage Organizations (MAOs) , OIG

OIG Approves Arrangement Regarding Drug Cost Subsidies for Certain Low-Income Medicare Enrollees

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-07 (the “Opinion”), to a nonprofit tax-exempt grant-making...more

9/6/2024 / Department of Health and Human Services (HHS) , Drug Pricing , Healthcare , Medicare , OIG , Pharmaceutical Industry , Prescription Drugs , Rural Areas , Social Security Act

OIG Approves Arrangement Regarding Patient Assistance Funds for Patients With Certain Rare Diseases, Pending Medicare Part D...

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-02 (the “Opinion”) to a nonprofit organization that provides...more

5/2/2024 / Anti-Kickback Statute , Cost-Sharing , Department of Health and Human Services (HHS) , Medicare , Medicare Part D , OIG , Patient Assistance Programs , Prescription Drugs , Proposed Amendments , Social Security Act

OIG Issues New Guidance on Financial Restructuring Arrangements With FQHC Look-Alikes

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 22-17, analyzing the proposed restructuring of financial relationships...more

9/23/2022 / Anti-Kickback Statute , Department of Health and Human Services (HHS) , Hospitals , HRSA , OIG , Restructuring

Analysis of Recent OIG Advisory Opinion on Employment of Excluded Individuals

The Department of Health and Human Services, Office of Inspector General (OIG) recently released a favorable advisory opinion, OIG Advisory Opinion No. 22-11 (the “Opinion”), analyzing the proposed employment of an individual...more

6/22/2022 / Department of Health and Human Services (HHS) , Employees , Employer Liability Issues , Excluded Providers , Federal Health Care Programs (FHCP) , Health Care Providers , Healthcare , Hiring & Firing , OIG , Workers' Compensation Claim

Lisa Churvis

Arnall Golden Gregory LLP

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