Violations of the federal Anti-Kickback Statute (the “AKS”)[1] have long served as a basis for liability under the federal False Claims Act (the “FCA”).[2] Recently, however, there has been increasing uncertainty regarding how far a violation of the AKS sweeps to render claims “false” under the FCA. Courts are currently at odds with each other...
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...
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 Samuel Aduley for...
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...
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...
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...
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 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...
Following the passage of the Affordable Care Act (“ACA”), which placed new limits on physician-owned hospitals, St. Luke’s Health System (“System”) took action to change one of its hospital’s ownership structures through a buy-out of the physicians’ partnership interests pursuant to the Texas Securities Act (“TSA”). The TSA allows rescission for the original price paid...
All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made statements signaling that the agencies are focused on reducing prescription drug prices. In remarks at the Food and...
Alissa SmithAlissa represents health systems, hospitals, pharmacies, long-term care providers, home he...
Hannah McCallumHannah brings specialized knowledge and real-life experience to help her clients make infor...
Andrew BrantinghamAndrew's experience spans a wide range of industries, and has particular depth in...
Rebecca BrommelBecki assists clients in the areas of litigation and administrative law wit...
Katie CownieKatie has worked on business and corporate issues for more than 20 years. Many of...
Lillie CoxLillie assists a wide array of healthcare industry clients with corporate transact...
Ross C. D'EmanueleRoss works in the health care provider, payor, and drug and medical device segment...
Nathan EbnetNate represents clients in all stages of complex civil disputes, from pre-...
Elise FesterElise counsels a wide variety of clients in the Health Care industry on regulatory...
Adam FreedAdam provides strategic advice to health care providers through all stage...
Randall HansonRandall is an associate in Dorsey’s health transactions and regulations practice group.
Alan IversonAlan is a litigator in Dorsey’s trial group with a focus on clients in...
Michael JenkinsMike serves clients in highly regulated industries, including health care and gam...
Jamie McCartyJamie counsels clients in the healthcare industry in connection with complex busi...
Neal N. PetersonNeal regularly advises clients regarding compliance with laws specific to the he...
Mara SandersMara regularly advises clients on matters of state and federal regulatory complia...
Vanessa J. SzalapskiVanessa's practice focuses on litigation in the healthcare industry, including gen...
Claire H. ToppClaire works in three diverse sectors – health care, tax exempt organizations,...
