News & Analysis as of

Health Care Providers › Medical Devices › Safe Harbors

Knobbe Martens

Application of Safe Harbor Exceptions to the Anti-kickback Statute

Knobbe Martens on

On August 7, 2025, the Office of the Inspector General (“OIG”) issued Advisory Opinion 25-09 (“Advisory Opinion”) providing a favorable opinion regarding remuneration to physicians with an ownership interest in a medical...more

McDermott Will & Schulte

AdvaMed Updates Code to Provide Guidance on Innovative Arrangements, Medical Technology, Interactions with HCPs

McDermott Will & Schulte on

The Advanced Medical Technology Association (AdvaMed) announced its revised Code of Ethics on Interactions with Health Care Professionals (2022 Code) on March 18, 2022. Notable updates to the 2022 Code provide guidance on...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

MoFo Life Sciences

Is 2021 The Value-Based And Shared Savings Revolution?

MoFo Life Sciences on

By now you are likely aware of the new safe harbor provisions of the federal anti-kickback statute (AKS), which the U.S. Office of Inspector General (OIG) finalized as of January 19, 2021. Among other changes to the AKS...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

Morgan Lewis

OIG Embraces Broader Anti-Kickback Statute Safe Harbor Protection for Warranties

Morgan Lewis on

The US Department of Health and Human Services’ Office of Inspector General updated the warranty safe harbor to account for bundled product and service warranties to reflect realities of healthcare product sales, but rejects...more

Faegre Drinker Biddle & Reath LLP

Patient Engagement Tools and Supports: Analysis of the New Anti-Kickback Statute Regulatory Safe Harbor

Faegre Drinker Biddle & Reath LLP on

Providers have a new tool in their toolbox to promote population health. The Health and Human Services Office of Inspector General (OIG) has adopted a new, extremely broad safe harbor that allows certain providers to give...more

Nilan Johnson Lewis PA

Anti-Kickback Statute and Stark Law Regulations: Final Rules Issued

Nilan Johnson Lewis PA on

On November 20, 2020, the Department of Health and Human Services (HHS) published two final rules that aim to reduce regulatory barriers to care coordination and accelerate the transformation of the healthcare system to...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

Skadden, Arps, Slate, Meagher & Flom LLP on

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Cooley LLP

Blog: OIG Advisory Opinion Permits Refunding Device Purchase Price Under Limited Conditions

Cooley LLP on

On September 17, 2018, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-10 regarding a proposed arrangement in which a surgical device and wound care product manufacturer (“Manufacturer”) will offer its...more

Mintz - Health Care Viewpoints

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

Mintz - Health Care Viewpoints on

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

11 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up Log in
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide