News & Analysis as of

Public Comment Civil Monetary Penalty

Mitchell, Williams, Selig, Gates & Woodyard,...

Multimedia Environmental Enforcement: Idaho Department of Environmental Quality and Elmore/Owyhee Counties Beef Feedlot Operator...

The Idaho Department of Environmental Quality and Idaho State Department of Agriculture (collectively, “IDEQ”) entered into an August 15th Draft Consent Judgment (“CJ”) with J.R. Simplot Co. and Simplot Livestock Co....more

Dorsey & Whitney LLP

Executive Order 14105 on Outbound Investment in China and Proposed Rule

Dorsey & Whitney LLP on

On August 9, President Biden issued Executive Order 14105 (“EO 14105”) on Addressing United States Investments in Certain National Security Technologies and Products in Countries of Concern. EO 14105 significantly reshapes...more

Baker Donelson

Office For Civil Rights Seeks Input on Implementation of HITECH Amendments

Baker Donelson on

On April 6, 2022, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released a Request for Information (RFI) seeking public comment on "recognized security practices" and on sharing civil...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

Jackson Lewis P.C.

DOL Adopts Portions Of Tipped Regulations Final Rule, Proposes Further Delay Of Other Portions

Jackson Lewis P.C. on

While deciding to make effective some portions of the Tipped Regulations Final Rule published in the final weeks of the former administration, the U.S. Department of Labor (DOL) has proposed further delay and consideration of...more

Jackson Walker

CMS Implements Stricter COVID-19 Testing Regulations on Nursing Homes

Jackson Walker on

As part of a broader Trump administration announcement made on August 25, 2020, the Centers for Medicare & Medicaid Services (CMS) issued sweeping oversight changes in the form of an Interim Final Rule with Comment Period...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - July 2020: Made in the USA: The Federal Trade Commission Proposes a New Rule to Protect U.S. Manufacturers and...

On June 22, 2020, the Federal Trade Commission (FTC) announced a Notice of Proposed Rulemaking pertaining to “Made in USA” claims, which applies to labels and marketing that fraudulently asserts that products are made in the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Highlights From the Recently Issued Proposed Regulations Under Sections 162(f) and 6050X

On May 13, 2020, the U.S. Treasury Department and Internal Revenue Service issued proposed regulations under Sections 162(f) and 6050X of the Internal Revenue Code regarding the disallowance of deductions for certain amounts...more

Mintz - Health Care Viewpoints

HHS Proposes Sweeping Changes to AKS and Stark Law, Part 6: Proposed Changes to the AKS Related to Beneficiary Inducement

As reported previously, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) recently published two proposed rules that seek to implement wholesale changes to the Anti-Kickback Statute (AKS) and...more

Jones Day

OIG Proposes New Exception for Dialysis-Related Telehealth Technologies

Jones Day on

The Situation: Telehealth services continue to evolve and show promise for improving quality care, care coordination, and access to services while also reducing the costs of care. The Action: The Office of Inspector...more

Sheppard Mullin Richter & Hampton LLP

Critical Analysis of CMS’ Proposed Stark Law Changes

As part of HHS’ Regulatory Sprint to Coordinated Care, CMS recently published a proposed rule that, if finalized, would fundamentally change and alleviate the manner in which the Stark Law regulatory framework has...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

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

Katten Muchin Rosenman LLP

CMS Proposes Sweeping Revisions to the Stark Law

"CMS Proposes Sweeping Revisions to the Stark Law" is Part I of a two-part series discussing the US Department of Health and Human Services' (DHHS) recent proposed rules revising the Stark Law and the Anti-Kickback Statute as...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

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 & Schulte

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

McDermott Will & Schulte 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: Recent Developments Impacting Drug Pricing and the 340B Program: Part 2

K&L Gates LLP on

In Part Two of this two-part series on recent developments in pharmacy law and the 340B drug pricing program, Richard Church and Ryan Severson discuss several recent developments related to the 340B drug pricing program,...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

Akin Gump Strauss Hauer & Feld LLP

Red Notice Newsletter - September 2018

ANTICORRUPTION DEVELOPMENTS - Petrobras Settles with U.S. Authorities Over Alleged FCPA Violations - On September 27, 2018, the U.S. Department of Justice (DOJ) and the Securities and Exchange Commission (SEC)...more

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