Category: Anti-Kickback

How EKRA and AKS Impact Laboratories and Commission-Based Compensation

With the enactment of the Eliminating Kickbacks in Recovery Act (“EKRA”) in 2018, the permissibility of commission-based compensation to laboratory sales representatives based on volume, revenue, or profit has come under question, and there is still little case law interpreting the Act. Despite EKRA being a relatively newer law, laboratories should remain mindful of how...

HHS OIG Releases an Updated Health Care Fraud Self-Disclosure Protocol

On November 8, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) released a revised Provider Self-Disclosure Protocol, renamed Health Care Fraud Self-Disclosure Protocol (“SDP”).  Prior to this update, the SDP had not been updated since 2013.  While many of the revisions were procedural only, some of the revisions were...

SCOTUS Denies Review of Dismissal at DOJ’s Request; Circuit Split Remains

The Dorsey Health Law blog team keeps readers up-to-date on relevant topics in the health care industry. In order to do so, the members of the blog team communicate regularly with other practice groups within the firm for applicable updates from client publications. For this post, we would like to thank Dorsey’s Christopher DeLong for...

OIG Advisory Opinion No. 21-02 Provides Helpful Insights into Risk Mitigation Factors Regarding Health System-, Physician-, and Management Company-Owned Ambulatory Surgery Centers

On April 26, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) issued favorable Advisory Opinion No. 21-02 regarding a proposed investment in an ambulatory surgery center (“ASC”) by a health system, orthopedic surgeon and neurosurgeon employees of the health system, and a management company. This latest Advisory Opinion is notable...

The “Regulatory Sprint to Coordinated Care” – Overview and Links to Further Resources from Dorsey & Whitney

In 2018, the U.S. Department of Health and Human Services (“HHS”) launched the “Regulatory Sprint to Coordinated Care” to accelerate a transformation of the healthcare system, with a focus on removing “unnecessary obstacles” to coordinated care (the “Regulatory Sprint”). Several HHS agencies requested comments and information from the public and have published new or proposed...

White Papers: Understanding the Final Rules to Revise the Stark Law, Anti-Kickback Statute and Beneficiary Inducement Civil Monetary Penalty Regulations

In just two weeks, on January 19, 2021, a sweeping set of changes to the federal physician self-referral law (or “Stark Law”) and anti-kickback statute (“AKS”) regulations go into effect.  These changes, which are part of the U.S. Department of Health and Human Services (“HHS”) “Regulatory Sprint to Coordinated Care,” are the most significant changes...

OIG Skeptical of Medical Device and Pharmaceutical Speaker Programs

The Department of Health and Human Services Office of Inspector General (“OIG”) has issued a Special Fraud Alert to highlight what it views as inherent risks associated with speaker programs that pharmaceutical and medical device companies organize and fund. These programs are typically company-sponsored events at which one or more physicians or other health care...

Much-Anticipated Final Rules to Revise Stark Law, Anti-Kickback Statute, Beneficiary Inducement CMP Regulations Released under “Regulatory Sprint to Coordinated Care”

On November 20, 2020, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their much-anticipated final rules to revise the federal self-referral law (or “Stark Law”) regulations, the safe harbors under the federal anti-kickback statute (AKS), and regulations under the...

OIG Initiatives to Ease Provider Burdens Related to COVID-19

The U.S. Department of Health and Human Services Office of Inspector General (“OIG”) has taken numerous steps to minimize regulatory burdens for providers who need to make their primary focus delivering patient care during the COVID-19 national emergency. These steps, along with recent steps taken by other agencies to provide temporary regulatory flexibility, provide further...

First EKRA Enforcement Announced

The first publicly disclosed prosecution under the Eliminating Kickbacks in Recovery Act (“EKRA”) occurred last month, a little over a year after EKRA became law. As we described in a previous blog post, EKRA criminalizes certain health care payment arrangements related to referrals, regardless of payor. In the recent EKRA prosecution, an office manager of...