News & Analysis as of

Pharmacies Office of the Inspector General

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding Proposed Patient Assistance Program Operated by a Nonprofit Grant-Making...

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On August 20, 2024, OIG issued Advisory Opinion No. 24-07 in which it responded to a request for an advisory opinion regarding a nonprofit grant-making organization’s (Requestor) proposal to fund a patient assistance program...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2024 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including guidance regarding hospital...more

Harris Beach PLLC

HHS Office of Inspector General November 2023 Enforcement Activity

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The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | August 2023 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more

Womble Bond Dickinson

[Webinar] First Annual Health Care Fraud Symposium - March 14th, 12:00 pm - 1:30 pm ET

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Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | July 2022 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant activity between June 21 and July 20, 2022. During this period, the Supreme Court of the United States overturned Roe v. Wade, which historically...more

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

Mintz - Health Care Viewpoints

OIG Approves Online Retailer’s Discount Program

On January 19, 2022, the Office of Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding an online retailer’s proposal to make its discount programs available to...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

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

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The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

Oberheiden P.C.

Eight Keys to Developing an OIG Compliance Program for Hospitals

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The Office of Inspector General is a division of the U.S. Department of Health and Human Services that is tasked with combating fraud committed against Medicare, Medicaid, and other federally funded government programs. The...more

Hogan Lovells

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

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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

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Managed Care Compliance Conference - February 1st - 3rd, 9:30 am - 3:45 pm CST

The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more

Epstein Becker & Green

HHS’s Efforts to Reduce Prescription Drug Prices and Transition to Value-Based Care – Part 1: CMS and OIG Issue a Series of Final...

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In a completely unexpected move, on November 20, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) published advance...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Virtual Regional Healthcare Compliance Conference - Indianapolis, IN - September 25th, 8:30 am - 4:30 pm EDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...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

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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

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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

Health Care Compliance Association (HCCA)

Proper use of the KX modifier for Part B immunosuppressive drug claims

Compliance Today, December 2019 - According to a recent MLN Connects notice, “A recent Office of the Inspector General (OIG) report noted that, in some cases, pharmacies incorrectly billed Medicare Part B for claims using...more

King & Spalding

HHS Issues Proposed Rule to Update Anti-Kickback Statute Safe Harbors – What Does it Mean for Life Sciences Companies?

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HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers - In today’s Federal Register, the...more

Bricker Graydon LLP

OIG says Part D contracts cost Medicare as much as $75 million in lost drug manufacturer rebates in one year

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The Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report on July 1, 2019, finding that Medicare Part D contracts between Medicare Prescription Drug Plan sponsors and drug...more

Holland & Knight LLP

New Medicare Part D Demonstration to Address Proposed Changes to Anti-Kickback Safe Harbors

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• The Centers for Medicare & Medicaid Services (CMS) has announced a new Medicare Part D demonstration to address the potential implementation of a recent proposed rule that would exclude from anti-kickback safe harbor...more

McGuireWoods LLP

HHS OIG Issues Proposed Rule Altering AKS Safe Harbor for Pharmacy Benefit Manager Rebates

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The federal Anti-Kickback Statute (AKS) prohibits the knowing and willful solicitation, receipt, offer or payment of any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, in return for or to...more

Verrill

OIG Proposes Revisions to Anti-Kickback Safe Harbor Regulations Affecting Prescription Drug Rebates

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Recently, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) in the Federal Register to amend the federal anti-kickback statute safe harbor...more

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