Hospice Insights Podcast - Where’s the Line: When Does Poor Quality Create False Claims Liability
AI and the False Claims Act
HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance
Hospice Insights Podcast - Hospice Audit Updates: David Beats Goliath
AGG Talks: Home Health & Hospice Podcast - Episode 10: Anti-Kickback Compliance for Hospice and Skilled Nursing Providers
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
AGG Talks: Home Health & Hospice Podcast - Episode 7: OIG Report Reveals Gaps in Hospice PRF Compliance: What Providers Need to Know
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Navigating GSA Audits Compliance Strategies and Best Practices
DE Under 3: US DOL Inspector General’s Office Report Cites IT Modernization & Security Concerns
Medical Device Legal News with Sam Bernstein: Episode 17
Episode 280 -- Healthcare Compliance and Fraud
Heed Caution: Takeaways From the OIG's Advance Care Planning Report
Telehealth Risk Report: What the Government Found
UPIC Report Card: The OIG’s Evaluation of the UPICs Provides Insight Into the Future of Hospice Audits
COVID-19 Hospice How-To Series | Pulling the Strings: New OIG Audits Scrutinize How Hospices Used Provider Relief Funds
In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General (OIG), manufacturers have contested the OIG’s...more
The Centers for Medicare & Medicaid Services (CMS) recently issued several important updates concerning the reporting of Average Sales Price (ASP) with potential implications for manufacturers. ...more
On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more
The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more
Although most of the recent focus around the implementation of the Inflation Reduction Act (“IRA”) by the press and industry stakeholders has been on the Medicare Drug Price Negotiation Program, the IRA has several other...more
On Thursday, February 23, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued its first Advisory Opinion (“AO”) of the new year – OIG AO No. 23-01 – permitting a drug...more
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
The Office of Inspector General (OIG) of the U.S. Department of Health and Human Services has issued Advisory Opinion 2022-22, stating that it would not impose sanctions related to a proposed arrangement where a...more
Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more
This special inaugural issue of McDermott’s Healthcare Regulatory Check-Up highlights noticeable enforcement activity, OIG regulatory developments, CMS regulatory developments and other key developments for healthcare...more
On November 10, 2021, OIG issued Advisory Opinion No. 21-16 permitting an arrangement whereby a drug manufacturer (Requestor) provides free samples of a long-acting injectable atypical antipsychotic drug (the Drug) to certain...more
The Pharmaceutical Research and Manufacturers of America (PhRMA) – a leading lobbying and advocacy group for drug manufacturers – has released an updated version of its “Code on Interactions with Health Care Professionals”...more
Last week, OIG posted Advisory Opinion No. 21-08 regarding a pharmaceutical manufacturer’s arrangement to provide financial assistance in the form of transportation, lodging, and meals to patients potentially eligible for...more
On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more
In its March 18, 2021 Advisory Opinion (AO), AO 21-01, HHS Office of Inspector General (OIG) determined that a pharmaceutical manufacturer that produces a drug as a one-time, potentially curative treatment (the Drug) may...more
On March 18, the Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 21-01 (Opinion) regarding a free drug program sponsored by a pharmaceutical manufacturer of a personalized cell and gene therapy...more
On March 18, 2021, OIG issued Advisory Opinion 21-01, addressing whether a pharmaceutical manufacturer may provide a personalized medicine made from a patient’s own cells as a one-time, potentially curative treatment (the...more
A pharmaceutical manufacturer has received a green light from the Office of Inspector General (OIG) to provide financial assistance for travel, lodging and other expenses to certain patients prescribed the manufacturer's...more
From December 23, 2020 through December 31, 2020, the OIG issued several advisory opinions. The advisory opinions analyzed (1) a program for a pharmaceutical manufacturer to provide financial assistance to certain patients,...more
On 20 November 2020, the United States Department of Health and Human Services (HHS) Office of the Inspector General (OIG) released its final rule on drug rebates entitled “Removal Of Safe Harbor Protection For Rebates...more
On November 20, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued a Final Rule to finalize a February 6, 2019 proposal stripping rebates received from drug manufacturers by...more
Final Rule Closely Resembles Previously Withdrawn 2019 Proposed Rule - INTRODUCTION - On November 20, 2020, as part of a release of several drug pricing rules, the U.S. Department of Health and Human Services (“HHS”)...more
Food - FDA Releases Resources on Food Traceability Proposed Rule – The FDA released a resource to allow users to explore the results of the Risk-Ranking Model for Food Tracing used in the development of the Food Traceability...more
On September 23, 2020, the Office of Inspector General of the United States Department of Health and Human Services (OIG) publicly released Advisory Opinion 20-05 (AO 20-05), a significant, adverse opinion rejecting a...more
We are back again with another 340B post. The 340B program has recently been a regular feature on the blog in the context of ongoing litigation discussed here and here. Today, we wanted to provide readers the details of an...more