News & Analysis as of

Safe Harbors Department of Health and Human Services (HHS) Health Care Providers

WilmerHale

Second Circuit Confirms Willfulness under the Anti-Kickback Statute and False Claims Act Requires Relators to Plead that the...

WilmerHale on

The Second Circuit Court of Appeals recently issued a decision with significant implications for healthcare companies and providers facing allegations of violations of the Anti-Kickback Statute (AKS), 42 U.S.C. §...more

Oberheiden P.C.

Ultimate Guide to the Anti-Kickback Statute

Oberheiden P.C. on

All healthcare providers and other businesses in the healthcare industry need to comply with the Anti-Kickback Statute (AKS). The AKS imposes criminal penalties for knowing and willful violations, and even inadvertent...more

Stevens & Lee

OIG Issues Favorable Opinion Concerning Bonus Payments to Employed Physicians

Stevens & Lee on

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) recently considered the question whether an employed physician can be paid bonus compensation relating to procedures performed by the...more

Stevens & Lee

OIG Says Proposed Surgery Monitoring Arrangement May Violate Kickback Statute

Stevens & Lee on

On August 18, the Office of Inspector General in the Department of Health and Human Services (“OIG”) issued Advisory Opinion 23-05 in which it concluded that a proposed arrangement involving the formation of a company...more

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

King & Spalding

AdvaMed Updates Code of Ethics on Interactions with HCPs: What’s the Impact on MedTech?

King & Spalding on

On March 18, 2022, the Advanced Medical Technology Association (“AdvaMed”) announced revisions to its Code of Ethics on Interactions with Health Care Professionals (“Code”). The revised Code will take effect June 1, 2022. ...more

Arnall Golden Gregory LLP

OIG Approves Arrangement That Provides Cash Equivalents to Patients in Digital Contingency Management Program

On March 2, 2022, the Department of Health and Human Services, Office of Inspector General (OIG) published Advisory Opinion No. 22-04 (the “Opinion”), analyzing a program whereby the Requestor provides comprehensive digital...more

Proskauer - Health Care Law Brief

OIG Publishes Favorable Advisory Opinion Related to the Employment Safe Harbor

In an advisory opinion posted November 10, 2021 (AO 21-15), the Office of the Inspector General of the United States Department of Health and Human Services (OIG) appeared to soften a disturbing position that it had taken in...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

Rivkin Radler LLP

OIG Issues Favorable Advisory Opinion On Hospital/Physician Joint Venture ASC

Rivkin Radler LLP on

In a recent advisory opinion, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) concluded that certain investments by a health system, manager and physicians in an ambulatory surgery center...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

Hinshaw & Culbertson - Health Care

New OIG Guidance Permits Federally Qualified Health Centers to Offer Remote Patient Monitoring, Big-Box Store Gift Cards, and...

Federally Qualified Health Centers (FQHCs) deliver care to some of the nation's most vulnerable individuals and families, including federal Medicare and Medicaid health care program beneficiaries. As safety net 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

ArentFox Schiff

New Safe Harbors Offer Opportunities for Innovative Arrangements, Including Digital Health

ArentFox Schiff on

Recent updates to the federal Anti-Kickback Statute give providers additional flexibility to enter into innovative arrangements, but before doing so, providers must ensure they understand the safe harbor requirements...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

Jones Day

Recent Changes to the Anti-Kickback Statute’s Personal Services Safe Harbor

Jones Day on

The Situation: The Office of Inspector General ("OIG") recently modified the personal services and management contracts safe harbor of the federal Anti-Kickback Statute ("AKS"). These modifications expand protections to...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

McGuireWoods LLP

Fraud and Abuse Rules Part IV: Final Changes to Existing and New Anti-Kickback Statute Safe Harbors

McGuireWoods LLP on

As discussed in a prior McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute...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

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

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