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Patients Advisory Opinions

Foley Hoag LLP

Summary and Key Considerations of Recent HHS-OIG Advisory Opinion on Pharmaceutical Patient Assistance Program for Rare Disorders

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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

Sheppard Mullin Richter & Hampton LLP

OIG Issues Favorable Advisory Opinion Regarding Patient Assistance Funds

Recently, the Department of Health and Human Services Office of Inspector General (“OIG”) released Advisory Opinion (“Opinion”) 24-02 regarding patient assistance funds provided by a non-profit charitable organization...more

Sheppard Mullin Richter & Hampton LLP

New OIG Opinion Permits Gift Cards to Beneficiaries in Limited Circumstances

On March 24, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion 23-03 (the “Opinion”), in which it decided not to impose sanctions on an Arrangement to provide prepaid gift cards to patients for certain...more

McDermott Will & Emery

OIG Issues AO on Providing Gift Cards for Completed Colon Cancer Screening Tests

McDermott Will & Emery on

The US Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion (AO) 23-03, analyzing a proposed arrangement in which a company that manufactures an at-home colon cancer...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Laboratory Arrangement to Offer Discounts

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On March 29, 2023, OIG posted Advisory Opinion No. 23-03 regarding a laboratory’s proposed arrangement to provide a prepaid card of up to $75 to encourage individuals to return the sample collection kit associated with the...more

Bass, Berry & Sims PLC

OIG Approves Gift Cards to Promote Patient Compliance with a Preventive Screening Measure

The U.S. Department of Health and Human Services Office of Inspector General (OIG) recently issued Advisory Opinion 23-03, approving a proposal by the manufacturer of a colorectal cancer screening test and its wholly owned...more

Bass, Berry & Sims PLC

OIG Approves DME Manufacturer Loan Program in Latest Advisory Opinion

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On June 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-13, approving an arrangement under which a durable medical equipment (DME) manufacturer...more

Bass, Berry & Sims PLC

OIG Approves Arrangement that Provides Cash Equivalents to Patients in Latest Advisory Opinion

On March 2, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-04, approving a program under which the requestor provides digital contingency management...more

Bass, Berry & Sims PLC

OIG Approves a Free Drug Program Limited to Hospital Inpatients

Bass, Berry & Sims PLC on

On November 16, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) published Advisory Opinion 21-16, approving an arrangement under which a pharmaceutical manufacturer provides free...more

Baker Donelson

OIG Okays Assistance Arrangement Offered to Drug Patients in Advisory Opinion 20-02

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In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more

Holland & Knight LLP

Healthcare Law Update: September 2018

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Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Holland & Knight LLP

Healthcare Law Update: May 2018

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Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

Holland & Knight LLP

OIG Issues Letter Declining to Impose Administrative Sanctions for Provision of Certain Free Drugs

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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

Akerman LLP - Health Law Rx

OIG Issues Favorable Opinion Giving Green Light To Health System’s Shuttle Service

The Office of Inspector General (OIG) recently issued another advisory opinion on free patient transportation (OIG Adv. Op. No. 15-13, dated October 21, 2015). In the opinion, the OIG addresses whether providing patients a...more

Perkins Coie

OIG Warns Lab “Pull-Through” Arrangements May Be Illegal

Perkins Coie on

In an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in...more

McAfee & Taft

OIG rejects management arrangement that carves out federal healthcare program patients

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The Office of Inspector General of the Department of Health and Human Services recently posted an Advisory Opinion describing a proposed arrangement by a clinical laboratory. ...more

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