News & Analysis as of

Civil Monetary Penalty Comment Period Proposed Rules

Venable LLP

CFIUS Proposes Increased Penalties for Noncompliance and Updated Mitigation and Enforcement Rules

Venable LLP on

As the lead agency for the Committee on Foreign Investment in the United States (CFIUS or the Committee), the U.S. Department of the Treasury released new proposed rules on April 11, 2024 intended to enhance the enforcement...more

Goodwin

FinCEN Proposes Rule for SARs Sharing Pilot Program

Goodwin on

In This Issue. The Financial Crimes Enforcement Network (FinCEN) issued a proposed rule about the establishment of a limited-duration pilot program for sharing suspicious activity reports (SARs); FinCEN published the final...more

BakerHostetler

The Race to Modernize Stark and the AKS: Unpacking the Value-based Proposals in HHS Regulatory Sprint Rulemaking

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The U.S. Department of Health & Human Services (HHS) made great strides in its race to modernize and clarify the regulations interpreting the federal physician self-referral law (Stark), Anti-Kickback Statute (AKS) and...more

Seyfarth Shaw LLP

New Safe Harbors In A Storm of Risk and Regulations: A Review of the OIG’s Proposed Changes to the Federal Anti-Kickback Laws

Seyfarth Shaw LLP on

In an effort to modernize and clarify a statute that looms large in the minds of health care providers across the nation, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) recently...more

Epstein Becker & Green

HHS’s Regulatory Sprint to Coordinated Care – Part 3: CMS Proposes Expansive Set of Changes to Stark Regulations

Epstein Becker & Green on

This Client Alert serves as the third in a three-part series in which we describe and analyze the rules proposed by the Department of Health and Human Services (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) as part...more

Bass, Berry & Sims PLC

CMS and the OIG Issue Far-Reaching Proposed Rules to the Federal Stark and Anti-Kickback Laws

Bass, Berry & Sims PLC on

In a coordinated effort, CMS and the Office of Inspector General (OIG) published proposed rules to modernize regulations implementing the federal physician-self referral law, commonly referred to as the “Stark Law” (Stark),...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 2: Cybersecurity Technology and Electronic Health Records

On October 17, 2019, the Department of Health & Human Services (HHS) published two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that, if...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Katten Muchin Rosenman LLP

OIG Proposes to Add and Expand AKS Safe Harbors

Key Points - On October 17, 2019, the OIG proposed rules to add safe harbor protections for coordinated care and associated value-based arrangements. - The OIG proposed several new safe harbors: value-based...more

Womble Bond Dickinson

Trump Administration’s ‘Regulatory Sprint’ Includes Revisions to Stark Law and Anti-Kickback Statute

Womble Bond Dickinson on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) released two proposed rules: Modernizing and Clarifying the Physician Self-Referral Regulations and Fraud and Abuse; Revisions to Safe Harbors under the...more

Akin Gump Strauss Hauer & Feld LLP

CMS Proposes Changes to Physician Self-Referral Regulations to Promote Value-Based Health Care

• The Centers for Medicare and Medicaid Services (CMS) have issued a long-awaited proposal to reform the Physician Self-Referral Law’s (Stark Law’s) regulatory exceptions and to provide updated guidance for physicians and...more

Wilson Sonsini Goodrich & Rosati

HHS Announces Overhaul of Kickback and Stark Rules

On October 9, 2019, the U.S. Department of Health and Human Services' (HHS') Centers for Medicare and Medicaid Services (CMS) and Office of Inspector General (OIG) announced plans for sweeping changes to rules policing health...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 1: Value-Based Arrangements

As we reported last week, the Department of Health & Human Services (HHS) recently issued two proposed rules (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services (CMS)) that,...more

Faegre Drinker Biddle & Reath LLP

New Stark Law Exceptions for Value-Based Care

On October 9, 2019, the U.S. Department of Health and Human Services released proposed changes to the Ethics in Patient Referrals Act (the “Stark Law”), as well as the Medicare and Medicaid Anti-Kickback Statute (the...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

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to Anti-Kickback Statute and Stark Law

On October 9, 2019, the Department of Health & Human Services (HHS) announced significant changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (known as the Stark Law) through proposed rules issued...more

McDermott Will & Emery

HHS Proposes Substantial Changes to Stark Law and Anti-Kickback Statute Regulations

McDermott Will & Emery on

The Department of Health & Human Services’ (HHS) proposed changes to the Stark Law, the Anti-Kickback Statute, and the Civil Monetary Penalty Law, released today as part of the Regulatory Sprint to Coordinated Care, would...more

K&L Gates LLP

K&L Gates Triage: Digital Health Update: ONC Information Blocking Proposal Aims to Remove Barriers to Data Sharing

K&L Gates LLP on

The Office of the National Coordinator for Health Information Technology (ONC) recently released a proposed rule aimed at promoting the interoperability of health information technology and enabling access to electronic...more

Sheppard Mullin Richter & Hampton LLP

The Military Health Care Fraud and Abuse Prevention Program: The Department of Defense Issues Proposed Regulations regarding...

The U.S. Department of Defense (“DOD”) claims that fraud and abuse is inhibiting the ability of the Defense Health Agency (“DHA”), the agency responsible for administering TRICARE, to support and deliver “integrated,...more

Hogan Lovells

340B program: Proposed rule would accelerate the effective date of the CMP Final Rule from July 1, 2019, to January 1, 2019

Hogan Lovells on

This week, the Health Resources and Services Administration (HRSA) issued a Proposed Rule (Proposed Rule) to cease any further delay of the 340B Ceiling Price and Civil Monetary Penalties regulation (CMP Final Rule) and...more

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