News & Analysis as of

Department of Health and Human Services (HHS) Exceptions

Bradley Arant Boult Cummings LLP

Healthcare Alert - HHS Information Blocking Rule: The 8 Exceptions

Two years ago, the U.S. Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) issued regulations under the 21st Century Cures Act advancing the interoperability of electronic health...more

Bradley Arant Boult Cummings LLP

Federal Agencies Release Interim Final Rule to Implement the No Surprises Act

Today, the Departments of Health and Human Services (HHS), Labor, and Treasury (the Departments) published an interim final rule (the Interim Final Rule) implementing certain provisions of the No Surprises Act,[1] which aims...more

Epstein Becker & Green

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

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

Butler Snow LLP

The New Stark Law Value-Based Exceptions Seek to Advance the Shift from Volume to Value in the Delivery of Health Care in the...

Butler Snow LLP on

On November 20, 2020, the Department of Health and Human Services (HHS) released final rules, effective as of January 19, 2021 (with limited exception), amending and updating the Stark Law, the Anti-Kickback Statute (AKS),...more

Verrill

The Regulatory Sprint is Over – What’s at the Finish Line Under the New Stark and AKS Final Rules?

Verrill on

The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare &...more

McDermott Will & Emery

Stark and AKS Final Rules Will Facilitate Donations of EHR and Cybersecurity Technology and Services

McDermott Will & Emery on

On November 20, 2020, the Centers for Medicare and Medicaid Services and Office of Inspector General released final rules amending the regulations to the Stark Law and the Anti-Kickback Statute and Beneficiary Inducement...more

Tucker Arensberg, P.C.

It Is Not Illegal to Pay Physicians More Than They Generate

While we are waiting for final disposition of the AKS Safe Harbors and Stark Exceptions proposed in October of 2019, since the comment period expired December 31, 2019 and final rules have not been issued, I thought we should...more

Manatt, Phelps & Phillips, LLP

[Webinar] Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms - February 13th, 1:00 pm ET

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for...more

K&L Gates LLP

Triage in 2020: Health Care Topics to Watch in the New Year

K&L Gates LLP on

In this week's episode, Lindsey Rogers-Seitz forecasts a number of critical issues spanning the health care industry that are likely to be points of focus in the coming year. Among these issues, Ms. Rogers-Seitz discusses the...more

Baker Donelson

Regulatory Sprint: HHS Proposes Expansion of Protections for EHR and Cybersecurity Donations

Baker Donelson on

In furtherance of its goals of expanding the adoption of electronic health records (EHR) and improving security through the use of cybersecurity technology, the Department of Health and Human Services (HHS) has proposed...more

Tucker Arensberg, P.C.

Regulatory Sprint to Coordinated Care: New Stark & Anti-Kickback Rules

Tucker Arensberg, P.C. on

On October 22, 2019, CMS and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory...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

Proskauer Rose LLP

HHS Releases Proposed Stark Law, Anti-Kickback Statute, and Civil Monetary Penalties Law Reforms

Proskauer Rose LLP on

On October 9, 2019, the Department of Health and Human Services ("HHS") issued proposed changes to the regulations implementing the Physician Self-Referral Law (the "Stark Law"), the Anti-Kickback Statute (the "AKS"), and the...more

WilmerHale

Proposed Changes to Stark and Anti-Kickback Regulations May Provide New Flexibility for Healthcare Providers

WilmerHale on

On October 9, 2019, the Department of Health and Human Services (HHS) announced proposals for a number of new and revised exceptions to the Stark Law and safe harbors for the Anti-Kickback Statute (AKS) that are intended to...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

Faegre Drinker Biddle & Reath LLP

New Proposed Cybersecurity and EHR Donation Rules

On October 9, 2019, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) simultaneously released a set of proposed rules (the “Proposed Rules”) that, among other...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

McDermott Will & Emery

ONC Proposes to Define Conduct That Is Not Information Blocking under the Cures Act

McDermott Will & Emery on

The ONC finally released its long-awaited proposed rule to implement the “information blocking” prohibition of the 21st Century Cures Act by identifying conduct that is not information blocking. If finalized, ONC’s proposed...more

Holland & Knight LLP

GAO Reviews Issues in Implementing and Reporting on the Buy American Act

Holland & Knight LLP on

The Government Accountability Office (GAO) recently published a report on the federal government implementation of the Buy American Act. The Buy American Act of 1933 is one of several statutes implementing a preference for...more

Baker Donelson

What Hospitals Need to Know About the Natural Disaster Exception to Stark Law

Baker Donelson on

Hospitals operating in regions affected by the recent hurricanes and other natural disasters may be able to obtain temporary regulatory relief. During times of disasters and emergencies, CMS can provide some flexibility...more

Foley & Lardner LLP

HIPAA for HR - Some Good News for Employers

Foley & Lardner LLP on

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that was enacted to ensure protection of individuals’ protected health information (PHI). The Standards for Privacy of Individually...more

Sheppard Mullin Richter & Hampton LLP

OCR to Focus More Investigative Resources on Smaller HIPAA Breaches with Less Than 500 Individuals Affected

The Department of Health & Human Services (DHHS) Office of Civil Rights (OCR) recently announced it will devote more resources to investigate smaller HIPAA breaches. Before this announcement, OCR typically opened...more

Mintz - Health Care Viewpoints

Senate Committee Releases Report on Potential Stark Law Changes, Hearing Scheduled

On June 30, 2016, the Senate Finance Committee’s Republican staff issued a 20-page report discussing comments made by industry stakeholders after a December 2015 round-table on the future of the physician self-referral law,...more

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