News & Analysis as of

Office of the Inspector General Civil Monetary Penalty Pharmacies

Arnall Golden Gregory LLP

OIG’s First Advisory Opinion of 2022 Allows for Expansion of Discount Programs

On January 19, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) released a favorable advisory opinion, OIG Advisory Opinion No. 22-01 (the “Opinion”), analyzing a proposed expansion of...more

Bass, Berry & Sims PLC

Government Appeals Decisions in 340B Contract Pharmacy Litigation

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On December 28, 2021, the federal government submitted notices to appeal three federal district court decisions related to the use of contract pharmacies under the federal 340B drug pricing program. The appeals are the latest...more

Hogan Lovells

2020 final price reporting developments: stimulus legislation, 340B contract pharmacy Advisory Opinion

Hogan Lovells on

As we begin the new year, we wanted to highlight two final developments from December 2020: First, on Dec. 27, 2020, the stimulus legislation H.R. 133, the Consolidated Appropriations Act of 2021 (link), Pub. L. 116‑260...more

Baker Donelson

OIG Approves Loyalty Rewards Program in Supermarket Pharmacies

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In its last Advisory Opinion of 2019 (19-06), the OIG approved a proposed arrangement involving a retailer rewards program through which out-of-pocket costs on in-store pharmacy purchases would qualify customers for future...more

McGuireWoods LLP

OIG Issues Advisory Opinion Approving Supermarket Pharmacy Loyalty Program

McGuireWoods LLP on

On December 17, 2019, the Office of Inspector General (OIG) issued an Advisory Opinion regarding a proposed supermarket loyalty program that would have provided customers with rewards points on out-of-pocket costs related to...more

King & Spalding

OIG Approves Customer Loyalty Program Involving Pharmacy Products

King & Spalding on

On December 17, 2019, OIG published Advisory Opinion 19-06 approving a supermarket’s expansion of a loyalty program to allow customers to earn rewards points on out-of-pocket costs paid in connection with the purchase of...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

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Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

BakerHostetler

OIG Signs Up for Customer Loyalty Program

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In Advisory Opinion 17-05, posted by the U.S. Department of Health and Human Services Office of Inspector General (OIG) on September 7, 2017, the OIG approved a pharmacy’s customer loyalty/discount program (Benefit Program)....more

Davis Wright Tremaine LLP

New Year, New Possibilities: OIG Final Rule Amends Beneficiary Inducement Rules

The Office of Inspector General (“OIG”) of the Department of Health and Human Services has issued a final rule (“Final Rule”) adding new safe harbors to the federal anti-kickback statute, amending existing safe harbors, and...more

Baker Donelson

OIG Finalizes New and Amended Anti-Kickback and CMP Safe Harbors

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On December 7, 2016, the Department of Health and Human Services Office of the Inspector General (OIG) issued a final rule to establish new safe harbors under the anti-kickback statute and civil monetary penalty (CMP) rules,...more

Baker Donelson

HHS OIG Expands Safe Harbors, but Doubles Down with Enhanced Civil Monetary Penalties

Baker Donelson on

The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) published two rules on December 7, 2016, updating certain existing safe harbor regulations, adding new safe harbor rules under...more

Proskauer Rose LLP

HHS OIG Adopts NewAnti-Kickback Safe Harbor and Civil Monetary Penalty Exceptions

Proskauer Rose LLP on

On December 7, 2016, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), issued a final rule that will have a widespread impact on health care service providers, medical transport providers,...more

McDermott Will & Emery

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

McDermott Will & Emery on

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more

King & Spalding

OIG Issues Final Rule Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

King & Spalding on

On December 7, 2016, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published a final rule to amend the Anti-Kickback Statute (AKS or Statute) by adding new safe harbors. The Final Rule...more

King & Spalding

OIG Issues Two Favorable Advisory Opinions

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OIG recently issued two favorable advisory opinions. On August 12, 2015, OIG approved a program that provides a free cancer drug approved under the FDA’s Breakthrough Therapy Designation to patients who meet certain criteria...more

Cooley LLP

Blog: HHS OIG Approves Drug Company Program Providing Free Cancer Treatment Drugs

Cooley LLP on

On Tuesday, the Health and Human Services (HHS) Office of Inspector General (OIG) issued an Advisory Opinion regarding a program to provide a 30-day supply of cancer drugs free of costs to patients who experience an insurance...more

Foley & Lardner LLP

HRSA Proposes Civil Monetary Penalties for Drug Manufacturers that Overcharge 340B Covered Entities

Foley & Lardner LLP on

The Health Resources and Services Administration (HRSA) within the U.S. Department of Health and Human Services (HHS) published a notice of proposed rulemaking impacting the 340B Drug Pricing Program (340B Program) on June...more

K&L Gates LLP

A Possible Green Light for Patient Transportation Services: OIG Proposes Revised Safe Harbors to the Anti-Kickback Statute for...

K&L Gates LLP on

On October 3, 2014, the Office of Inspector General of the Department of Health and Human Services (“OIG”) published a proposed rule and request for comments (“Proposed Rule”), which would amend the Anti-Kickback Statute...more

McDermott Will & Emery

OIG Proposes Expanding Anti-Kickback Statute Safe Harbors and Revising Civil Monetary Penalty Regulations

McDermott Will & Emery on

On October 2, 2014, the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) published a proposed rule containing revisions to both the Anti-Kickback Statute (AKS) safe harbors and the civil...more

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