Recently enacted federal law expanding criminal liability for kickbacks related to all payors, and increased government enforcement activity in behavioral health (see press release), has heightened the importance of clinical due diligence for private equity investors targeting deals and acquisitions in the emerging behavioral health space. PE firms continue to target behavioral health opportunities as federal and commercial insurance coverage expands for mental health, including substance abuse treatment and telehealth services. Such commercial coverage will only become more commonplace after a federal court this month found United Behavioral Health improperly denied benefits for treatment of mental health and substance use disorders to plan participants because United’s guidelines did not comply with the terms of its own insurance plans and state law.[1] PE firms entering the behavioral health market, though, particularly opportunities related to substance abuse treatment and laboratory services, should carefully review a company’s compliance with the Eliminating Kickbacks in Recovery Act of 2018 (“EKRA”).
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Do the Detailed Federal Requirements for Addressing Sex Discrimination Apply to Your Hospital?
When Title IX of the Education Amendments of 1972, 20 U.S.C. § 1681, et seq. (“Title IX”), which prohibits many forms of discrimination on the basis of sex, appears in the news or on social media, we typically associate it with traditional colleges and universities. But recent case law suggests that Title IX likely applies to a broader set of institutions, including, under certain circumstances, some hospitals.
Over the years, an extensive body of federal case law and regulation has arisen around Title IX, imposing detailed requirements on institutions concerning how they must respond to and investigate complaints, how complaints must be adjudicated and the nature of appropriate remedies. Moreover, these regulations also have recently been in flux. As a result, Title IX compliance often requires significant institutional resources and constant vigilance.
Because compliance with Title IX requires significant attention from the institution, it is critical that hospitals determine whether they meet the developing criteria to be subject to the requirements of Title IX and, if so, whether they have in place the proper policies, procedures and personnel to ensure compliance. In this article, we describe those criteria and provide a brief summary of the broader legal context.
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Workplace Violence Protection Act: Illinois Hospitals and Healthcare Providers Face New Challenge
Last August, the Healthcare Worker Violence Protection Act was signed into law by Illinois Governor Rauner. This law creates a new set of employee rights and obligations for healthcare providers in Illinois. Generally, this law is designed to provide personal safety to frontline healthcare providers, such as doctors and nurses, and protect the rights of those who would raise or report safety concerns and assaults by expanding the Illinois Whistleblower Act.
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Sexual Abuse of People with Disabilities
The Rape, Abuse and Incest National Network (“RAINN”) reports that sexual assault and abuse of people with disabilities often goes unnoticed, and, according to the National Crime Victimization Survey, people with disabilities are victimized by crime at higher rates than the rest of the population. Too often, it is the caregivers who are the perpetrators. While one with a disability may give consent to sexual activity, there can never be consent between one who is disabled and receiving care and a member of the caregiving staff.
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HHS proposes moving up the enforcement of 340B penalties to January 1, 2019
On Wednesday, the Department of Health and Human Services (“HHS”) reversed course in its delay of implementing fines against drug manufacturers that intentionally overcharge 340B providers. In a notice of proposed rulemaking, HHS intends to advance the effective date of its final rule on the 340B drug price ceiling and civil monetary penalties to January 1, 2019, rather than July 1, 2019, as previously proposed.
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DOJ Adds Private Equity Firm to False Claims Act Complaint
The United States Department of Justice (“DOJ”) has intervened in a False Claims Act (“FCA”) case against a Florida compounding pharmacy, Diabetic Care Rx, LLC d/b/a Patient Care America (“PCA”), and, in an unexpected move, named PCA’s private equity sponsor and controlling shareholder, Riordan, Lewis & Haden, Inc. (“RLH”), as a co-defendant. The DOJ complaint accuses PCA, RLH and two PCA officers/directors (who were also RLH partners) of overseeing a kickback scheme which DOJ alleges induced referrals that resulted in TRICARE paying over $68 million for medically unnecessary compound drug prescriptions. DOJ alleges the illegal scheme was designed by RLH.
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Need a Lift? Uber Enters the Healthcare Arena
Earlier this month, Uber released its new program, Uber Health. In a nutshell, Uber Health is a program that facilitates patient transportation to and from appointments with healthcare providers. This post expands on a previous post regarding patient ridesharing programs.
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In healthcare worker safety, California leads the way
In the last two months, the healthcare industry has seen both federal and state efforts to further regulate healthcare worker safety. Stakeholders and other jurisdictions are keeping an eye on these developments, which could spread to other states, as well.
While the federal legislation is focused on reducing workplace violence at healthcare facilities, an initiative in California will decide what additional regulations should be imposed to remove surgical plume and limit the exposure of healthcare professionals to surgical smoke in the state’s operating rooms.
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What Health Care Providers Need to Know About Patient Rideshare
The debate over providing transportation to patients is nothing new. Hospitals, doctors and other providers have long struggled with whether they can provide free or discounted taxis, shuttles, metro cards or other transportation means to patients to come to appointments and receive care. On one hand, there is evidence that without reliable transportation options, patients are more likely to miss preventative, primary care appointments, increasing the risk of more costly and unnecessary medical services down the road. On the other hand, certain federal laws like the Anti-Kickback Statute (AKS) and Civil Monetary Penalty (CMP) law have given providers serious concerns that such transportation services might be considered an illegal “kickback” to gain patients, or an illegal inducement to receive care.
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REMINDER: February Deadline for HIPAA Breach Reporting
With the New Year underway, the deadline is quickly approaching for HIPAA covered entities to file their annual breach reports with the U.S. Department of Health & Human Services Office for Civil Rights (“OCR”).
While breaches involving 500 or more individuals must be reported no later than 60 calendar days from the date of discovery,