News & Analysis as of

Patient Safety Anti-Kickback Statute

King & Spalding

OIG Issues Favorable Advisory Opinion on a Drug Manufacturer’s Provision to Hospitals of Trial Units of Antipsychotic Medication...

King & Spalding on

On December 22, 2022, OIG issued a favorable advisory opinion concluding that it would not impose administrative sanctions on a pharmaceutical manufacturer for providing trial units of a certain antipsychotic drug (Drug) to...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 8th - 10th, Anaheim, CA

Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more

King & Spalding

OIG Issues Advisory Opinion Permitting Drug Manufacturer to Provide Travel, Lodging, and Expenses to Patients in Limited...

King & Spalding on

On January 15, 2020, OIG issued Advisory Opinion No. 20-02 analyzing an arrangement between a pharmaceutical manufacturer and certain drug recipients whereby the manufacturer provides certain drug recipients with financial...more

Epstein Becker & Green

OIG Permits Manufacturer of Personalized Medicine Drug to Cover Patients’ Travel, Lodging, and Other Expenses

Epstein Becker & Green on

On January 21, 2020, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) published Advisory Opinion 20-02, approving an arrangement under which a pharmaceutical manufacturer provides...more

Mintz - Health Care Viewpoints

OIG Advisory Opinion Allows Smartphone Loan for Needy Patients Taking Digital Drug

Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a...more

King & Spalding

OIG Issues Advisory Opinion Giving the Green Light to a Pharmaceutical Manufacturer’s Plan to Provide Limited Functionality...

King & Spalding on

On January 24, 2019, OIG issued Advisory Opinion No. 19-02, analyzing a proposed arrangement in which a pharmaceutical manufacturer would loan smartphones to patients who meet certain poverty level requirements in order to...more

Akin Gump Strauss Hauer & Feld LLP

OIG Approves Manufacturer Loaning Smartphones as Appropriate Patient Assistance to Support Digital Medicine

On January 29, the Health and Human Service Office of Inspector General (OIG) released new guidance that sheds further light on the types of patient assistance that may be provided under the “Promotes Access to Care”...more

Sheppard Mullin Richter & Hampton LLP

Kickbacks Aren’t Illegal Just for Federal Health Care Programs in Recently Enacted SUPPORT Act: New Compliance Concerns for...

On October 24, 2018, President Trump signed the “Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act” or the “SUPPORT for Patients and Communities Act” (the “SUPPORT...more

Baker Donelson

OIG Advisory Opinion 17-03 Approves Pharmaceutical Manufacturer's Product Spoilage/Replacement Program

Baker Donelson on

A pharmaceutical manufacturer proposing to offer customers – at no additional cost – replacements for certain spoiled products that can no longer be administered to patients (Replacement Program) has been granted approval by...more

Holland & Knight LLP

Healthcare Law Update: September 2017

Holland & Knight LLP on

OIG Advisory Opinions - Manufacturer's Free Replacement of Spoiled Pharmaceutical Products Authorized - On Aug. 25, 2017, the U.S. Department of Health and Human Services' (HHS) Office of Inspector General (OIG)...more

Akerman LLP - Health Law Rx

The AHA’s Letter to Santa Claus

The American Hospital Association, after having been “nice” all year, penned its letter to Santa Claus with its wish list for Christmas. Its four page letter (actually addressed to President-Elect Donald Trump at 1717...more

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