News & Analysis as of

Department of Health and Human Services (HHS) Office of the Inspector General Safe Harbors

Gardner Law

OIG’s Perspective on Discount and Refund Programs

Gardner Law on

The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....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

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...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

Holland & Knight LLP

OIG Looks at How Employed Physicians Bonuses Are Paid from ASC Profits

Holland & Knight LLP on

The U.S. Department of Health & Human Services Office of the Inspector General (OIG) on Oct. 13, 2023, posted Advisory Opinion No. 23-07 detailing a favorable response to a proposal by a Requestor to pay bonuses to its...more

Bass, Berry & Sims PLC

OIG Approves Paying Employed Physicians Profits from ASCs Operated by Employer

Bass, Berry & Sims PLC on

On October 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07, approving a physician practice’s proposal to pay its physician-employees a portion of 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

Jones Day

HHS-OIG Issues FAQ Guidance Related to Pharmacy Benefit Manager Arrangements

Jones Day on

The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...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

Sheppard Mullin Richter & Hampton LLP

Pharmaceutical Manufacturers Ask EDVa to Allow Cost-Sharing Under the AKS

Pharmaceutical manufacturers are challenging the breadth of the Federal Anti-Kickback Statute (“AKS”) in federal court, arguing that the government is harming the very vulnerable patients it aims to serve by prohibiting...more

ArentFox Schiff

OIG Declines To Challenge Debt Cancellation and Restructured Financial Arrangements Between Health System and FQHC “Look-Alike”...

ArentFox Schiff on

In Advisory Opinion 22-17, the US Department of Health and Human Services (HHS) Office of Inspector General (OIG) concluded that a proposed restructuring of a loan and other contractual relationships between a health system...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

Bass, Berry & Sims PLC

OIG Approves Arrangement that Provides Cash Equivalents to Patients in Latest Advisory Opinion

On March 2, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-04, approving a program under which the requestor provides digital contingency management...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

Saul Ewing LLP

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

Saul Ewing LLP on

In a recent advisory opinion, the Office of Inspector General (“OIG”) of the U.S. Department of Health and Human Services (“HHS”) concluded that an investment by a health system, a management company, and surgeons in an...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

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