News & Analysis as of

Health Care Providers Comment Period Value-Based Care

Benesch

CMS Proposes Comprehensive Updates to Remote Patient Monitoring and Remote Therapeutic Monitoring Reimbursement

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On July 14, 2025, the Centers for Medicare & Medicaid Services (“CMS”) issued the CY 2026 Medicare Physician Fee Schedule (“PFS”) Proposed Rule. Published in the Federal Register on July 16, 2025, the rule outlines...more

McDermott Will & Schulte

HHS Releases Draft Federal Health IT Strategic Plan for 2020-2025

The Department of Health and Human Services released its draft 2020-2025 Federal Health IT Strategic Plan for public comment. This article outlines the goals of the plan, as well as challenges in healthcare that ONC hopes the...more

BakerHostetler

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

BakerHostetler on

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

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

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

Polsinelli

Assessing the Stark and Anti-Kickback Proposals for Value-Based Arrangements

Polsinelli on

Through two separate notices of proposed rule-making (NPRMs), the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG), seek to remove...more

Robinson+Cole Health Law Diagnosis

CMS Proposes to Newly Define Commercially Reasonable, and Tweak Definition of Fair Market Value, in New Physician Self-Referral...

On October 17, 2019, the Centers for Medicare & Medicaid Services (CMS) formally published its proposed rule (the PSR Rule) to update exceptions to the Physician Self-Referral Law (PSR Law, also known as the Stark Law). For...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

Polsinelli

Unique Opportunity to Influence Anti-Kickback Statute Rules

Polsinelli on

Starting today, the industry has 75 days to provide input on the proposed rules published in the Federal Register regarding the future enforcement of the Anti-Kickback Statute (AKS). ...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

King & Spalding

HHS Issues Proposed Rule to Update Anti-Kickback Statute Safe Harbors – What Does it Mean for Life Sciences Companies?

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HHS’ Proposals are Designed to Promote Patient Care Coordination, Management, and Efficiencies, and Include Several Points of Interest for Pharmaceutical and Medical Device Manufacturers - In today’s Federal Register, the...more

Foley & Lardner LLP

CMS Proposes Revisions to Stark Law

Foley & Lardner LLP on

On October 9, 2019, the Centers for Medicare & Medicaid Services (CMS) of the Department of Health and Human Services (HHS) released its long-awaited Proposed Rule (Proposed Rule) updating and clarifying the physician...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

Foley & Lardner LLP

The Regulatory Sprint to Coordinated Care: New Proposed OIG Rules Substantially Accelerate Post-Acute Care Coordination

Foley & Lardner LLP on

Big changes were announced this past week in what Health and Human Services (HHS) has labeled a “Regulatory Sprint to Coordinated Care.” Foley will be breaking down many of the areas of the proposed rule and the effects on...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

Burr & Forman

OCR Highlights - March 2019

Burr & Forman on

The U.S. Department of Health and Human Services Office of Civil Rights (“OCR”) was hard at work at the end of 2018—emphasizing the active efforts we have seen for the past few years from OCR. Below is a brief summary of some...more

Bass, Berry & Sims PLC

Modifying the HIPAA Rules: The Next Leg in HHS’s Sprint to Coordinated Care

Bass, Berry & Sims PLC on

On December 14, 2018, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) issued a Request for Information (RFI) seeking comments on potential modifications to the HIPAA Rules focused on...more

Sheppard Mullin Richter & Hampton LLP

OCR Seeks Ideas on HIPAA Rule Changes to Promote Value-Based Care and Coordinated Care

The Office for Civil Rights (“OCR”) issued a request for information (“RFI”) to assist OCR in identifying provisions of the Health Insurance Portability and Accountability Act (“HIPAA”) privacy and security regulations (the...more

Holland & Knight LLP

OCR Seeks HIPAA Comments on Coordinated Care

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The Department of Health and Human Services' Office for Civil Rights (OCR) has issued a Request for Information, which is scheduled for publication in the Federal Register on Dec. 14, 2018. OCR is asking the public to provide...more

Bass, Berry & Sims PLC

Sprinting to Coordinated Care: Healthcare Industry Urges Stark Law Relief as OIG Solicits Feedback on Changes to the Anti-Kickback...

August 24, 2018 marked a busy day for the U.S. Department of Health & Human Services' (HHS) self-designated "Regulatory Sprint to Coordinated Care," an initiative aimed at dismantling the regulatory barriers to providers...more

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