News & Analysis as of

Department of Health and Human Services (HHS) Health Insurance Portability and Accountability Act (HIPAA) Anti-Kickback Statute

Foley & Lardner LLP

Health-Related Social Needs: Three Trends in Leveraging Community Partnerships

Foley & Lardner LLP on

Leading health authorities have increasingly emphasized how non-medical factors such as socioeconomic status, education, employment, housing, food security, and community support have an outsized impact on health outcomes. By...more

McDermott Will & Emery

Healthcare Regulatory Check-up Newsletter | February 2024 Recap

McDermott Will & Emery on

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

Holland & Knight LLP

Key Value-Based Care Developments to Watch in 2024

Holland & Knight LLP on

The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more

The Volkov Law Group

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

The Volkov Law Group on

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

Bricker Graydon LLP on

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

Fox Rothschild LLP

In Case You Missed It: New OIG General Compliance Program Guidance

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On November 6, 2023, the HHS Office of Inspector General published a new compilation of compliance guidance under the title General Compliance Program Guidance (GCPG) for the healthcare compliance community and other health...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

Lathrop GPM

OIG Publishes New Compliance Guidance for Health Care Entities, Along with Plan for Targeted “Industry Specific” Guidance Starting...

Lathrop GPM on

On October 6, 2023, the Office of Inspector General at the U.S. Department of Health and Human Services (OIG) released brand new “General Compliance Program Guidance” to assist health care providers, entities, and other...more

Holland & Hart LLP

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

Holland & Hart LLP on

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

Morgan Lewis - Health Law Scan

OIG Unveils New General Compliance Program Guidance, First Major Update Since 2008

The US Department of Health and Human Services Office of Inspector General (OIG) released its new General Compliance Program Guidance (GCPG) on November 6, 2023. The GCPG is designed to serve as a reference guide for the...more

Butler Snow LLP

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

Butler Snow LLP on

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

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

Holland & Hart LLP

Public Health Emergency Ends May 11, 2023: Check Your Readiness

Holland & Hart LLP on

After three years, the federal public health emergency (PHE) will expire May 11, 2023. Most of the relaxed regulatory and payor standards will end on or within a few months after the deadline, including many relating to: ...more

Foley & Lardner LLP

Public Health Emergency Ends May 11: What Telehealth Companies Need to Know

Foley & Lardner LLP on

On January 30, 2023, the Biden Administration announced its intent to end the COVID-19 public health emergency (PHE) on May 11, 2023. The PHE has been in place for over three years during which time many telehealth and...more

Holland & Knight LLP

Healthcare Law Update: February 2021

Holland & Knight LLP on

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

Dorsey & Whitney LLP

The “Regulatory Sprint to Coordinated Care”

Dorsey & Whitney LLP on

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched what it calls a “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary...more

Morgan Lewis - Health Law Scan

HHS to Exercise Enforcement Discretion in Response to CMS Telehealth Waiver

As we noted in our previous Health Law Scan blog CMS Issues Program Instructions for Medicare Telehealth Waiver, CMS issued program instructions on March 17 to implement the Medicare telehealth waiver in response to the...more

Jones Day

Newly Proposed AKS and Stark Law Protections For Value-Based Care Models

Jones Day on

The Situation: The Department of Health and Human Services has introduced the Regulatory Sprint to Coordinated Care Initiative in order to revise regulations associated with the anti-kickback statute, Stark Law, HIPAA, and 42...more

Saul Ewing LLP

2020 Health Care Predictions

Saul Ewing LLP on

The Saul Ewing Arnstein & Lehr, LLP Health Care Practice includes attorneys that handle regulatory, compliance, transactional and litigation needs for clients across the entire health care delivery system, including: ...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

Tucker Arensberg, P.C.

Regulatory Sprint to Coordinated Care: CMS/AKS and OIG Stark Proposed Amendments

Tucker Arensberg, P.C. on

HHS has long admitted that the Anti-Kickback Statute (AKS) and the Stark law have not evolved to keep pace with the transition to value based care. In June of 2018, HHS issued an RFI seeking additional information and HHS...more

McGuireWoods Consulting

Washington Healthcare Update - October 2019 #3

McGuireWoods Consulting on

This week in Washington: House to hold a markup of five healthcare bills, as well as a hearing to seek clarity on the Trump administration's health care policy choices; Senate to discuss solutions to the substance misuse...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 1: CMS and OIG Issue Long-Awaited Proposed Rules

Epstein Becker & Green on

On October 9, 2019, the Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) took the next step in their Regulatory Sprint to Coordinated...more

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