Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.
Three family members involved in owning an addiction treatment center and/or a toxicology lab were charged in July with patient brokering and money laundering in an alleged scheme involving roughly $2 Million. The allegations arise out of a complex corporate enterprise involving at least four companies and some common ownership between the treatment center and lab. While it’s premature to assume that the defendants did anything illegal, there are some interesting things in this case:
Complexity Invites Suspicion. Every business owner in the addiction treatment and toxicology lab space knows three things: (1) it’s extremely regulated, (2) law enforcement has an especially sharpened focus on these industries, and (3) insurance companies are very suspect of any situation involving either industry, especially when there is any common ownership. So why then would one construct an enterprise that even “looks” complex or tricky? It intensifies suspicion in an already highly scrutinized business space. This is clearly one of the points of focus in this case. There’s an old saying woven into the mind of every experienced healthcare lawyer: if something can’t be done directly, it can’t be done indirectly. Time will tell if anything in this case was wrong or if there are any good reasons for the corporate structure, but the complexity of the corporate structure certainly invites suspicion. read more
Employers are approaching us in increasing numbers regarding their obligations toward employees battling substance abuse. Two federal laws primarily govern the space, the Americans with Disabilities Act and the Family and Medical Leave Act. Note that state laws may be more restrictive, so we encourage our clients to reach out to local attorneys to determine if additional legal protections are available to employees in their state.
The Americans with Disabilities Act (ADA) covers businesses with 15 or more employees to protects workers from discrimination based on a qualifying disability or a perceived disability, which is defined to include alcoholism and illegal drug use. However, to be eligible, the ADA protects only workers who either (i) have successfully been rehabilitated and are no longer using illegal drugs or misusing alcohol; or (ii) are currently participating in a rehabilitation program and are no longer using illegal drugs or misusing alcohol. Importantly, the ADA does not protect any employee who is presently battling alcoholism and illegal drug use and is not participating in a treatment program. An employee in the throes of substance abuse who is not actively seeking treatment is not protected by the ADA. read more
Federal law enforcement has traditionally prosecuted individuals utilizing healthcare fraud and abuse laws such as the Federal Anti-Kickback Statute, the False Claims Act, the Physician Self-Referral Law also known as the Stark Law as well as other administrative tools including exclusions and civil monetary penalties. In addition to these laws, federal law enforcement also has at their disposal other fraudulent act statutes such as mail and wire fraud. The facts of a case, however, may not provide for federal standing. For example, when individuals take out federal government payors out of the picture or from an arrangement as a way of avoiding federal jurisdiction. The new solution to this issue…a law enacted in 1961, the Travel Act. read more
One healthcare employer’s compensation arrangement with its employees just got much needed support from the 11th Circuit Court of Appeals. The employer there, which provided AIDS patients certain healthcare related services, paid its employees a bonus of $100 per patient. The case was brought on the argument that the compensation arrangement constituted an illegal kickback under the federal Anti- Kickback Statute. The court, however, disagreed because the employees who received the bonuses were “bona fide employees.”
The court’s focus on the plain language of the safe harbor for bona fide employees was refreshingly clear, notably that “any amount paid by an employer to an employee (who has a bona fide employment relationship with such an employer) for employment in the furnishing or any item or service.” Essentially, any amount paid by an employer to a bona fide employee is not considered to be “remuneration” under the Anti-Kickback Statute. read more
Municipalities throughout the nation continue to use zoning to exclude community residences from residential districts despite the presence of numerous court decisions that recognize community residences for people with disabilities as a residential use. Over the past year multiple Florida cities have imposed tougher regulations on community residences for people with disabilities. These communities include group homes, sober living homes, recovery communities, and assisted living facilities that emulate a biological family. In creating these regulations, cities cite to the protection of individuals from the actions of unscrupulous operators and also the need to avoid a concentration of community residences in one area that have shown to undermine the goals of the residents. Thus, if you are an operator in one of these cities, you may be subject to heightened scrutiny and additional documentation requirements ranging from simple registration to submitting an application for a conditional use permit requiring an appearance before a planning and zoning board. read more
A recent ruling by a state trial court handling the Palm Beach County Sober Home Task Force prosecutions against providers of addiction treatment and sober home services is creating lots of confusion and alarm around the state and could have very far reaching consequences for the entire healthcare industry well beyond addiction treatment.
The issue presented by the prosecution focuses on whether a person charged with violating the state’s Patient Brokering Act (PBA) can be found guilty even if he/she didn’t know what he was doing was unlawful. The PBA broadly prohibits paying someone for patient referrals, very much like the federal Anti-Kickback statute. If allowed, the client would have gotten legal advice, paid for it, followed it, and still not be able to show a judge or jury that, despite all their best efforts, they simply followed the law as instructed.
Can a healthcare facility or provider be guilty of violating a criminal law [the PBA] if they’d gotten legal advice and followed it? Traditionally, the answer would be a clear “no.” The argument against the State’s position would be something like “How can someone intend to violate a criminal law if they got legal advice regarding how to comply with it and then followed that advice?” The argument of the state might look something like “We don’t even think the judge or jury ought to be able to hear that the person got legal advice and followed it.” The court punted the issue to the appellate court. read more
On December 29, 2017, the Department of Children and Families (DCF) submitted comments for proposed changed to rule 65D-30, governing licensed substance abuse service providers. The proposed rule includes significant changes as compared to old 65D-30, and should be reviewed as soon as possible by all DCF-licensed substance abuse service providers. Comments must be received by DCF on or before January 19, 2018, and can be submitted via the form at the bottom of THIS LINK .The proposed changes are substantial, and we strongly recommend someone in each licensed service provider reviews them as soon as possible in order to ensure timely compliance.
This article will focus on changes in the licensing component of DCF’s rules. read more
In December 2016, the US Congress passed the 21st Century Cures Act, which, among other things, provided for increased funding for treatment and research of mental health and substance abuse disorders. That law also required the HHS Office of Civil Rights (OCR) to provide guidance in regards to HIPAA compliance in regards to those types of treatment. In October 2017, President Donald Trump declared the opioid addiction epidemic to be a public health emergency, which will also result in additional resources being allocated to addressing the crisis.
In connection with both the new law and the President’s declaration, OCR published its HIPAA guidance in December 2017. The guidance is intended to clarify how and when protected health information (PHI) can be shared in regards to patients in substance abuse and mental health treatment. According to OCR Director Roger Severino, “HHS is using every tool at its disposal to help communities devastated by opioids, including educating families and doctors on how they can share information to help save the lives of loved ones.” read more
Most commercial health plans require that prior to admission to a substance abuse treatment facility, patients must have a face-to-face individual assessment by a licensed behavioral health clinician 72 hours prior to admission, to determine if the admission is both medically necessary and clinically appropriate. Many potential patients reside in states outside of Florida (or a given destination), so complying with a face-to-face requirement when a patient is in another state before admission is a challenge. Telehealth is being increasingly utilized to evaluate these out-of-state patients and perform the necessary face-to-face evaluation in advance of arrival at a given facility. However, as with anything healthcare, there is a right way and a wrong way to implement this technology. In the coming weeks, we’ll be discussing many of the facets involved from telemedicine claims overpayments to Medicare telehealth law issues.
Earlier this month, Attorney General Jeff Sessions announced the formation of the Opioid Fraud and Abuse Detection Unit, which is a pilot program of the United Stated Department of Justice. AG Sessions noted that there are three components to approach the opioid crisis that our nation faces: prevention, treatment and enforcement.
Prevention. AG Sessions noted briefly that the DOJ is undertaking that component through raising awareness, through drug take-back programs, and through DEA’s 360 Strategy program, which incorporates law enforcement, diversion control and community outreach to tackle the cycle of violence and addiction in US cities. He also stated that law enforcement is a component of prevention.
Treatment. AG Sessions articulated that treatment can help break the cycle of addiction and crime and help people get their lives back together.
Enforcement. AG Sessions dove deep in the area of enforcement, reasoning that enforcing our laws helps keep drugs out of the hands of our citizens, decreases their availability, drives up their price, and reduces their purity and addictiveness. He added, “Enforcement will make a difference in turning the tide in this epidemic.”