Tagged: AKS

Recent DOJ Settlements Involving DME Manufacturers Highlight Important Anti-Kickback Considerations

The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback Statute (“AKS”). The AKS, found at 42 U.S.C. § 1320a-7b, prohibits the exchange of anything of value (i.e., remuneration) with any intent to induce referrals for services or products...

American Health Law Association 2022 Health Care Transaction Conference

After a 2-year hiatus, health care transactional attorneys and related industry professionals descended upon Nashville, TN April 25th – 27th for the 2022 American Health Law Association (“AHLA”) Health Care Transactions Conference. Aside from hot chicken and honky tonks, this conference was largely a celebration of the strength and resiliency of the health care industry...

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...

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...