News & Analysis as of

Centers for Medicare & Medicaid Services (CMS) Department of Health and Human Services (HHS) Safe Harbors

Hinshaw & Culbertson - Health Care

OIG Permits Health System and Federally Qualified Health Center Look-Alike Collaboration Agreement Restructuring Which Includes...

In OIG Advisory Opinion 22-17, the U.S. Department of Health and Human Services (H.H.S.) Office of Inspector General (OIG) analyzed a proposal whereby a regional non-profit health system would forgive debt owed by a federally...more

Maynard Nexsen

HHS Issues New Value-Based Care Exceptions and Safe Harbors to Stark Law and Anti-Kickback Statute

Maynard Nexsen on

On November 20, 2020, the Department of Health and Human Services (HHS), Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) issued final rules modifying regulations for the Physician...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

ArentFox Schiff

Arent Fox's Stark & Anti-Kickback Statute Final Rules Analysis

ArentFox Schiff on

Click the link below for our complete analysis of recent updates to the Stark Law and Anti-Kickback Statute and their impact on health care providers. ...more

K&L Gates LLP

Value-Based Safe Harbors and Exceptions to the Anti-Kickback Statute and Stark Law

K&L Gates LLP on

On 2 December 2020, the U.S. Department of Health and Human Services’ (HHS) issued two Final Rules in conjunction with its “Regulatory Sprint to Coordinated Care,” which will markedly change the regulatory fraud and abuse...more

Mintz - Health Care Viewpoints

HHS Finalizes Highly Anticipated Final Rule Amending Anti-Kickback Statute and Stark Law Regulations, Part V: Cybersecurity...

On January 19, 2021, significant changes to the regulations implementing the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (commonly known as the Stark Law) went into effect. The sweeping changes come...more

K&L Gates LLP

White Paper: Value-Based Safe Harbors and Exceptions to the Anti-Kickback Statute and Stark Law

K&L Gates LLP on

On 2 December 2020, the U.S. Department of Health and Human Services’ (HHS) issued two Final Rules in conjunction with its “Regulatory Sprint to Coordinated Care,” which will markedly change the regulatory fraud and abuse...more

PilieroMazza PLLC

Healthcare Blog Series: CMS and HHS-OIG Issue Final Rules Updating the Anti-Kickback Statute and Stark Law

PilieroMazza PLLC on

On November 20, 2020, over one year after releasing proposed changes to the Anti-Kickback Statute (AKS) and the Physician Self-Referral Law (Stark Law), the Department of Health and Human Services’ Office of the Inspector...more

K&L Gates LLP

White Paper: OIG Finalizes New and Revises Existing AKS Safe Harbors and Creates New CMP Law Exception

K&L Gates LLP on

On 2 December 2020, the Office of Inspector General (OIG) in the U.S. Department of Health & Human Services (HHS) issued a long-awaited final rule (the Final Rule or Rule). The Final Rule adds multiple new safe harbors,...more

McGuireWoods LLP

Fraud and Abuse Rules Part III: New Value-Based Arrangement Protections

McGuireWoods LLP on

As discussed in a previous McGuireWoods alert, the Department of Health and Human Services (HHS) published final rules, effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law (Stark Law), the...more

ArentFox Schiff

Searching for Safe Harbors? CMS-Sponsored Model Participants Receive Anti-Kickback Statute Protection

ArentFox Schiff on

Enrolling in such a CMS-sponsored innovation model now has an added benefit: a new Anti-Kickback Statute (AKS) safe harbor. ...In its mission to reward value over volume, the Centers for Medicare & Medicaid Services’ (CMS)...more

McGuireWoods LLP

Fraud and Abuse Rules Part II: Amended EHR and New Cybersecurity Donation Safe Harbors and Exceptions

McGuireWoods LLP on

As discussed in a previous McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules expected to be effective Jan. 19, 2021, that significantly amend the Physician Self-Referral Law...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

Jones Day

HHS Finalizes New AKS Safe Harbors for Patient Engagement and CMS-Sponsored Arrangements

Jones Day on

The Situation: As health care providers transition to value-based care models, they have often been forced to rely on safe harbors under the Anti-Kickback Statute, or AKS, that were never designed with value-based payment...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

Baker Donelson

Regulatory Sprint: Understanding the Impact on the Stark Law, Anti-kickback Statute, and Value-based Arrangements

Baker Donelson on

The Department of Health and Human Services has released extensive and significant revised final rules governing the Physician Self-Referral Law (the Stark law) and the Medicare Anti-Kickback Statute (AKS) in furtherance of...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Burr & Forman

Recent Stark Law Changes May Impact Physician Compensation Models

Burr & Forman on

On December 2, 2020, the Centers for Medicare and Medicaid Services (“CMS”) finalized sweeping changes to the federal Physician Self-Referral Law, commonly known as the Stark Law. Many of the changes reflect CMS’ intent to...more

Faegre Drinker Biddle & Reath LLP

HHS Issues Final Cybersecurity Safe Harbor and Exception

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) each released a final rule (the Final Rules). The Final...more

Mintz - Health Care Viewpoints

HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part IV: Changes to Existing Safe Harbors and...

As you know, we have been parsing through the HHS rules that finalize important changes to the Anti-Kickback Statute (AKS) and Physician Self-Referral Law (Stark Law) regulations. To recap, our team provided an overview of...more

ArentFox Schiff

New Stark Law and Anti-Kickback Reforms Aimed at Value-Based Care

ArentFox Schiff on

OIG and CMS, through a coordinated effort, have issued sweeping and much-anticipated final changes to the Anti-kickback and Stark rules. These changes are generally industry-friendly. Introduction - On November 20,...more

Mintz - Health Care Viewpoints

HHS Finalizes Highly Anticipated Final Rules Amending AKS and Stark Law Regulations, Part III: Value-Based Arrangements

As promised, our team has been studying the two final rules published by the Department of Health & Human Services (HHS) (one by the Office of Inspector General (OIG) and one by the Centers for Medicare & Medicaid Services...more

Epstein Becker & Green

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

Epstein Becker & Green on

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

Sheppard Mullin Richter & Hampton LLP

Eleventh Hour Rulemaking: HHS Eliminates Safe Harbor Protections for PBM Drug Rebates and Creates Two New Safe Harbors for...

On November 30, 2020, the United States Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a final rule (“Final Rule”) that makes significant changes to the federal Antikickback Statute...more

Mintz - Health Care Viewpoints

HHS Finalizes Highly Anticipated Final Rules Amending Anti-Kickback Statute and Stark Law Regulations, Part 2: Beneficiary...

While health care entities often want to provide free or discounted items or services to patients (e.g., free transportation, co-payment waivers, free supplies), these free or discounted items or services pose risk under both...more

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