News & Analysis as of

Health Insurance Portability and Accountability Act (HIPAA) False Claims Act (FCA) Department of Health and Human Services (HHS)

Proskauer - Health Care Law Brief

New HIPAA Requirements Place Additional Privacy Obligations on Covered Entities and Patients in an Effort to Protect Reproductive...

On April 22, 2024, the Office for Civil Rights (OCR) for the United States Department of Health and Human Services issued a Final Rule amending the Privacy Rule of the Health Insurance Portability and Accountability Act...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | April 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | February 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2024. We discuss various regulatory developments, including guidance on the use of AI in coverage decisions and texting...more

The Volkov Law Group

HHS-OIG Issues Comprehensive Compliance Guidance that Underscores the Need for a Robust and Independent Compliance Function (Part...

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The health care industry has a rich history of commitment and innovation in developing effective compliance  programs.  Going back to the 1990s, HHS elevated compliance program requirements for healthcare companies. Many of...more

Bricker Graydon LLP

A Long-Awaited Change: OIG Updates its Compliance Program Guidances

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From 1998-2008, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) published compliance program guidelines for various industries in the Federal Register....more

Goodwin

A Practical Look at OIG’s New Compliance Guidance

Goodwin on

On November 6, 2023, for the first time in 15 years, HHS OIG issued a new reference guide for the health care compliance community – the General Compliance Program Guidance, or GCPG. While the GCPG does not set new legal...more

McDermott Will & Emery

OIG Issues General Compliance Program Guidance Updates

McDermott Will & Emery on

On November 6, 2023, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) published the General Compliance Program Guidance (GCPG) as a revised reference guide for the healthcare compliance...more

Holland & Hart LLP

OIG Issued Updated General Compliance Program Guidance for Healthcare Providers and Stakeholders

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On Monday, November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released its General Compliance Program Guidance (“GCPG”) for the general healthcare compliance community and...more

Butler Snow LLP

Health Care Due Diligence: An Ounce of Prevention is Worth a Pound of Cure

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Due diligence properly performed in connection with the purchase and sale of a health care entity is simply different—vastly so—than due diligence performed in other contexts. Failure to recognize this reality can lead to...more

Proskauer - Health Care Law Brief

OIG Issues Final Information Blocking Enforcement Rule and Highlights the Potential for Referrals to the FTC and FCA Liability

On June 27, 2023, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services (“HHS”) released its final rule (“Final Rule”) implementing penalties for information blocking....more

Vicente LLP

Buying a Ketamine Clinic: Why, How, and Risks to Understand

Vicente LLP on

This article is part of a continuing series of articles regarding transactional legal issues in the emerging psychedelic space. With ketamine being the only approved psychedelic drug for medical use, ketamine clinics offer a...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - April 2023

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

American Conference Institute (ACI)

[Event] 14th Annual Advanced Forum on Managed Care Disputes and Litigation - March 29th - 30th, Chicago, IL

Hosted by ACI, 14th Annual Advanced Forum on Managed Care Disputes and Litigation returns for another exciting year with curated programming that will help you make sense of these developments, and their profound impact on...more

Harris Beach PLLC

OIG Enforcement Summary: August 16, 2022 – August 31, 2022

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The following is a summary of the 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 are...more

Holland & Knight LLP

Healthcare Law Update: February 2021

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To date, there has been little consistency in how Health Insurance Portability and Accountability Act (HIPAA) requirements are enforced by the U.S. Department of Health and Human Services (HHS), or the amount of settlements...more

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing Concerns Drive Continued DOJ Focus on Life Sciences Companies

In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more

Foley & Lardner LLP

Healthcare Law Review: Overview of the U.S. Healthcare System

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The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more

McDermott Will & Emery

Healthcare Enforcement Quarterly Roundup | Q2 2019

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In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Cozen O'Connor

The State AG Report Weekly Update April 2018 #2

Cozen O'Connor on

2018 AG Elections- Democrat William Tong Declares Candidacy for Connecticut Attorney General- Democratic state Representative William Tong announced he is running for Connecticut AG in 2018. As previously reported,...more

Holland & Knight LLP

Healthcare Law Update: June 2017

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Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Burr & Forman

Fraud and Abuse Investigations Should be Taken Very Seriously

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According to the United States Government, fraud and abuse recovery has an excellent return for each investment dollar spent. According to the Health Care Fraud and Abuse Control (HCFAC) Program Report,released by the...more

K&L Gates LLP

Health Care Institutions

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Originally published in Haig, Business and Commercial Litigation in Federal Courts, Fourth Edition §§ 87:1 et seq. © 2016 American Bar Association. This chapter discusses federal court litigation relating to health care...more

Burr & Forman

2016 Health Care Year in Review

Burr & Forman on

Since I began writing this year-end review in 2013, there have been some common themes – a shift to pay for quality and away from fee-for service, much of which has been brought about by the Affordable Care Act (ACA): efforts...more

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