I commented on a recent Ninth Circuit ruling clarifying a 2018 law that prohibits kickbacks for referring patients to medical testing labs and addiction treatment centers under the Eliminating Kickbacks in Recovery Act (EKRA).Continue Reading Ninth Circuit Ruling Outlining Kickback Limits Under EKRA
Danielle Sloane
Danielle Sloane helps national life science and healthcare companies navigate the complex maze of federal and state healthcare laws and regulations. With an analytical eye, Danielle helps her clients mitigate legal risk, innovate and achieve regulatory compliance consistent with their business goals.
Bass, Berry & Sims Notches Wins for Clients in Trio of False Claims Act Qui Tam Lawsuits
Bass Berry & Sims recently secured dismissals on behalf of healthcare providers in three separate False Claims Act (FCA) qui tam lawsuits in a matter of a week’s time. Continue Reading Bass, Berry & Sims Notches Wins for Clients in Trio of False Claims Act Qui Tam Lawsuits
How Health Care Companies Can Protect Against Government Scrutiny of COVID-19 Relief Funding
In our previous article, we outlined steps companies can take now to protect themselves during later government investigations and enforcement actions related to COVID-19 relief funding. These steps include: leverage compliance resources, document the application/funding process, document how money is used, schedule an interim internal review, and respond to employee complaints. In this article we focus specifically on the health care industry and how companies can protect against inevitable government scrutiny after receiving COVID-19 relief funding.
The health care industry must be particularly vigilant about protecting against future enforcement risks because it is a highly regulated industry facing an enforcement perfect storm—fast cash, poor guidance and retrospective review. Congress allocated $175 billion to the U.S. Department of Health and Human Services (HHS) through the Coronavirus Aid, Relief and Economic Security Act Provider Relief Fund (Relief Fund). To support an industry hurt by COVID-19-related patient surges, stay-at-home driven closures and elective procedure treatment delays, HHS adopted a strategy to release relief funds quickly and perform reconciliation on the back end. As a result, HHS released what it touted as “no strings attached” relief funds through a series of general and targeted allocations each with a list of somewhat vague terms and conditions. The only other guidance available were application instructions, where applicable, and a continuously evolving set of frequently asked questions.
Of course, no government funding comes with “no strings attached.” The government inevitably will review whether recipients of HHS relief funds met the eligibility requirements and complied with the terms and conditions for using relief funds. Given that any deliberate omission, misrepresentation or falsification of information related to the HHS relief funds comes with potentially severe consequences—including but not limited to revocation of Medicare billing privileges; exclusion from federal health care programs; and/or the imposition of fines, civil damages and/or imprisonment—health care companies should consider the following steps to support their acceptance and use of the funds:Continue Reading How Health Care Companies Can Protect Against Government Scrutiny of COVID-19 Relief Funding
Tuomey Affirmed; But CMS Throws the Healthcare Industry a Stark Law Life Raft
In a welcomed move, CMS has proposed changes to the federal physician self-referral law (Stark Law) designed to improve consistency and interpretability and alleviate the number of technical violations leading to self-disclosures. This move is in stark (pun-intended) contrast to the stringent interpretation of the Stark Law by the Fourth Circuit in its decision in…