News & Analysis as of

Anti-Kickback Statute Safe Harbors Fair Market Value

The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The... more +
The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -
ArentFox Schiff

Telehealth Staffing and Administrative Services Gain Favorable Advisory Opinion From OIG

ArentFox Schiff on

On June 6, the US Department of Health and Human Services’ Office of Inspector General (OIG) issued Advisory Opinion No. 25-03, providing important guidance for telehealth organizations and management services organizations...more

Health Care Compliance Association (HCCA)

Defensibility of a fair market value analysis

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

Nelson Mullins Riley & Scarborough LLP

New Opportunities in Value-Based Care Part 3: How to Create a Care Coordination Value-Based Enterprise

This is the third in a five-part series discussing the new Value-Based Regulations adopted last year by the Centers for Medicare & Medicaid Services and the Office of Inspector General. The Stark Value-Based Arrangement...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

Health Care Compliance Association (HCCA)

[Webinar] What Compliance Professionals Need to Know About the New Stark and Anti-Kickback Regulations - January 29th, 12:00 pm -...

Learning Objectives: - Explain changes to existing concepts including fair market value, commercial reasonableness, and volume or value - Examine the new definitions, exceptions, and safe harbors and their impact on...more

Jones Day

CMS Finalizes New Limitations to the Isolated Transactions Exception to the Stark Law

Jones Day on

The Situation: The isolated transactions exception under the Stark Law has been used by some providers and entities to retroactively protect services arrangements that do not qualify for personal services or fair market value...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

King & Spalding

Major Changes Finalized to Stark Rules, Anti-Kickback Statute Safe Harbors and the Beneficiary Inducements CMP

King & Spalding on

CMS and OIG released highly anticipated final changes to the rules implementing the Stark Law, the safe harbors issued under the Anti-Kickback Statute (AKS) and the beneficiary inducements provision in the civil monetary...more

Seyfarth Shaw LLP

OIG Releases Policy Statement Extending HHS Blanket Waiver Protection to Certain Federal Anti-Kickback Statute Violations During...

Seyfarth Shaw LLP on

On April 3, 2020, the Department of Health and Human Services’ Office of Inspector General (“OIG”) issued a policy statement of enforcement discretion (the “Policy Statement”) regarding sanctions under the Federal...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

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

Tucker Arensberg, P.C.

Regulatory Sprint to Coordinated Care: CMS/AKS and OIG Stark Proposed Amendments

Tucker Arensberg, P.C. on

HHS has long admitted that the Anti-Kickback Statute (AKS) and the Stark law have not evolved to keep pace with the transition to value based care. In June of 2018, HHS issued an RFI seeking additional information and HHS...more

Miles & Stockbridge P.C.

HHS Publishes Proposed Stark and AKS Updates

Miles & Stockbridge P.C. on

On October 9, 2019, the Department of Health and Human Services' Centers for Medicare and Medicaid ("CMS") and Office of Inspector General ("OIG"), respectively, published proposed rules updating the long-standing physician...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

Bricker Graydon LLP

CMS and OIG issue long-awaited rules proposing changes to the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil...

Bricker Graydon LLP on

On October 9, 2019, the Centers for Medicare and Medicaid Services (CMS) and Department of Health and Human Services Office of Inspector General (HHS-OIG) issued long-awaited proposed changes “to modernize and clarify the...more

Baker Donelson

HHS Proposes Removing Anti-Kickback Safe Harbor Protection for PBM Rebates, Proposes Two New Safe Harbors

Baker Donelson on

On January 31, the Department of Health and Human Services (HHS) and HHS Office of Inspector General (OIG) issued for public display a proposed regulation that would subject certain pharmaceutical manufacturer rebates paid to...more

Mintz - Health Care Viewpoints

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

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