News & Analysis as of

Safe Harbors Office of the Inspector General

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

Akerman LLP - Health Law Rx

New Safe Harbor and General Compliance Program Guidance Provides Opportunity for Buyers to Mitigate Litigation and Fraud Risk

By maintaining a robust compliance program, healthcare companies are better able to identify potential red flags early and to prevent violations of fraud and abuse laws. A failure to maintain an effective compliance program...more

Stevens & Lee

OIG Issues Unfavorable Opinion on Free Gifts for Purchasing Reimbursable Devices

Stevens & Lee on

The Office of Inspector General in the Department of Health and Human Services (“OIG”) recently issued Advisory Opinion 23-08 in which it concluded that a proposed arrangement involving a supplier’s durable medical equipment,...more

King & Spalding

OIG Issues Favorable Advisory Opinion Concluding Bonuses to Employed Physicians Are Not Kickbacks

King & Spalding on

Earlier this month, OIG issued Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the...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

Harris Beach PLLC

Safe Harbor Update: Increase in Annual Cap on Patient Engagement Tools and Supports

Harris Beach PLLC on

The safe harbor cap on remuneration for patient engagement and support is adjusted annually based on changes to the consumer price index (“CPI”). 42 C.F.R. §1001.952(hh) protects specified arrangements for patient engagement...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

King & Spalding

OIG Issues Unfavorable Advisory Opinion Regarding a Company’s Proposal to Create a Turnkey Physician-Owned Entity to Perform IONM...

King & Spalding on

On August 18, 2023, OIG posted Advisory Opinion No. 23-05 regarding a proposed arrangement in which the requesting entity (Requestor) proposed to assist physicians who perform surgeries using intraoperative neuromonitoring...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

K&L Gates LLP

Health Care Triage: Value-Based Lessons Learned: Two Years Later, How Have Providers Utilized New AKS and Stark Flexibilities?

K&L Gates LLP on

In this episode, Macy Flinchum talks with Limo Cherian and Steven Pine about some of the major takeaways, challenges, and successes that providers have experienced in navigating the new regulatory flexibilities for...more

King & Spalding

OIG Issues Guidance for Ambulatory Surgery Center Safe Harbor’s “One-Third” Income Test

King & Spalding on

In March, OIG published a new frequently asked questions (FAQ) page, General Questions Regarding Certain Fraud and Abuse Authorities. The FAQ page, located here, includes new guidance for ambulatory surgery center (ASC)...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

Harris Beach PLLC

Opinion on Possible Kickbacks Between Health System and Clinic

Harris Beach PLLC on

This opinion regards a proposed restructuring of financial relationships, which includes the forgiveness of debt, between a health system and a nearby clinic. ...more

Fenwick & West LLP

Compensating Physician Advisors with Equity: Considerations for Life Sciences Companies

Fenwick & West LLP on

Life sciences companies often engage physicians as consultants and advisors to serve on scientific or clinical advisory boards, or to otherwise obtain their expertise relating to product-specific research and development,...more

Venable LLP

Contractual Safeguards That Fall Short of a Safe Harbor

Venable LLP on

According to a recent Advisory Opinion from the Department of Health and Human Services (HHS) Office of Inspector General (OIG), a proposed fee arrangement could run afoul of the Federal anti-kickback statute, 42 USC...more

King & Spalding

OIG Issues Advisory Opinion Regarding Physician-Owned Device Company

King & Spalding on

On April 20, 2022, OIG issued an advisory opinion regarding an arrangement involving a family of physicians having an ownership interest in a medical device company that manufactures products that the physicians also order. ...more

Nelson Mullins Riley & Scarborough LLP

Using the New Value-Based Rules to Enhance Your ACO

In November 2020, the Centers for Medicare & Medicaid Services (CMS) finalized value-based exceptions under the Stark law, and the Office of Inspector General (OIG) finalized value-based safe harbors under the Anti-Kickback...more

McDermott Will & Emery

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

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

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

283 Results
 / 
View per page
Page: of 12

"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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide