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U.S. Department of Labor Settles Unprecedented Lawsuit Against United Healthcare for Violations of the Mental Health Parity and...

In the clearest indication yet of the increased enforcement of the Mental Health Parity and Addiction Equity Act (“MHPAEA”) under the Biden-Harris administration, two settlement agreements filed on August 11 provide that...more

Podcast: CMS and OIG Final Rules for Innovating Your Value-Based Payment Program - Diagnosing Health Care [Video]

The Centers for Medicare & Medicaid Services ("CMS") and the Office of Inspector General ("OIG") of the Department of Health and Human Services have at last published their long-awaited companion final rules advancing...more

Building Compliance Programs for AI Tools

Artificial Intelligence (“AI”) applications are powerful tools that already have been deployed by companies to improve business performance across the health care, manufacturing, retail, and banking industries, among many...more

Stark Law Updates Aimed at Advancing the Transition to Value-Based Care: CMS Issues a Final Rule Creating New Exceptions for...

On December 2, 2020, the Centers for Medicare & Medicaid Services (“CMS”) and the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) published in the Federal Register companion final...more

OIG Issues a Final Rule Designed to Advance the Transition to Value-Based Care and Modernize the Regulatory Framework

On December 2, 2020, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) and the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register long-awaited, companion...more

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

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

Secretary Azar Urges Governors to Take Action to Lift Restrictions to Extend the Capacity of the Health Care Workforce

In response to the growing concerns of the capacity of the health care workforce as a result of the COVID-19 pandemic, on March 24, 2020 the Secretary of Health and Human Services, Alex Azar, issued a letter and associated...more

HHS’s Regulatory Sprint to Coordinated Care – Part 2: OIG Issues Long-Awaited Proposed Rules

This Client Alert serves as the second in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) as part of its...more

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

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

Arrangements, Exceptions and Modifications- OIG and CMS Challenge the Status Quo

The Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services Office of Inspector General (OIG) issued their long-awaited proposed rules in connection with the Regulatory Sprint to...more

Response to RFIs: EBG Submits Comments to CMS on Stark Law Reforms and Is Preparing Comments to OIG on Anti-Kickback Statute and...

As addressed in a previous Epstein Becker Green (“EBG”) Client Alert, earlier this summer, the Centers for Medicare & Medicaid Services (“CMS”) published in the Federal Register a “request for information” (“RFI”) regarding...more

CMS Request for Information: Reforming the Stark Law to Facilitate the Transformation to Value-Based Care

On June 25, the Centers for Medicare and Medicaid Services (“CMS”) published in the Federal Register a “request for information” regarding potential reforms to the federal physician self-referral law (or the “Stark Law”). ...more

CMS Issues Long-Awaited Rule Regarding Reporting and Returning Overpayments

Section 6402(a) of the Affordable Care Act (“ACA”), which was enacted by Congress in 2010, requires a person who has received an overpayment to report and return the overpayment to the Secretary of Health and Human Services,...more

OIG Proposes New Safe Harbors to the Anti-Kickback Statute and New Exceptions to the Two Civil Monetary Penalty Provisions

On October 3, 2014, the Department of Health and Human Services’ Office of Inspector General (“OIG”) published a proposed rule (“Proposed Rule”) to add new safe harbors to the federal health care program anti-kickback statute...more

OIG Supplemental Advisory Bulletin on Patient Assistance Programs Leaves Open Questions for High-Cost Breakthrough Drugs in...

On May 21, 2014, the Office of the Inspector General ("OIG") of the Department of Health and Human Services issued a Supplemental Special Advisory Bulletin ("Supplemental Bulletin") addressing the risks that Independent...more

OIG Unveils Updated Self-Disclosure Protocol

In 1998, the Department of Health and Human Services' Office of Inspector General ("OIG") published the Self-Disclosure Protocol ("SDP"), which provides a mechanism through which health care providers may voluntarily report...more

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