Most everyone knows that laws are being implementing in federal and state government to address the opioid crisis in the US. One such law is the Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”) signed into law in October 2018 by President Trump. While the SUPPORT Act seeks to increase access to treatment for substance use disorders and prevention of substance use disorders, it also contains language to prevent abuse of the process to increase treatment access. Specifically, incorporated into the SUPPORT Act is the Eliminating Kickbacks in Recovery Act (“EKRA”) which directly targets unlawful referrals to recovery homes, clinical treatment facilities, and laboratories.
EKRA is similar to prohibited kickbacks and patient brokering pursuant to Sections 456.054 and 817.505, Florida Statutes, using similar language as both Florida statutes. EKRA makes it unlawful…
Imagine running a successful business: inventory is growing and flourishing, staff is happy, operations are smooth, and all of a sudden – a notification arrives that a bank foreclosed on the property the business rents from the landlord, with no advance notice.
In the blink of an eye, the location is gone, the risk of losing of inventory is imminent, and cash flow is impacted during the transition to find another cultivation space. This type of situation can, and has, happened. But what could have been done differently before establishing operations?
Pursuant to Section 456.44(3)(a), Florida Statutes, and Rule 64B-9.013(3)(a), Florida Administrative Code, a practitioner must evaluate a patient by taking a complete medical history and performing a physical examination prior to prescribing a controlled substance to a patient. The aforementioned statute and rule do not specifically rule out a patient evaluation taking place via a telemedicine visit. However, under current Florida law, only controlled substances used to treat psychiatric disorders may be prescribed using telemedicine technology, that is audio and video technology commonly referred to as telepsychiatry. Specifically, Rule 64B8-9.0141(4) states, “controlled substances shall not be prescribed through the use of telemedicine except for the treatment of psychiatric disorders.” Psychiatric disorders include Substance Use Disorders since the DSM-V classifies addiction as a mental health condition. Although the Standards for Telemedicine Practice under Rule 64B-9.0141, Florida Administrative Code, allows licensed practitioners to prescribe controlled substances for psychiatric disorders via telehealth technology, the federal law has lagged somewhat behind.
On November 29, 2018, Florida Representative Chuck Clemons proposed house bill 65 (“HB 65”) that would significantly tighten regulation on the use of stem cells. If the stem cell bill is signed into law, Florida will join other states (e.g. California, Texas and Washington) in passing some type of stem cell regulation. While some bills around the country have centered the regulation on informing prospective customers of the risks associated with these treatments, HB 65 takes a more stringent approach with the threat of criminal exposure and includes certain protections for providers in the form of a “right-to-try” law.
Attorneys Susan St. John and Michael Silverman of the Florida Healthcare Law Firm will present this live lunch n’ learn webinar for providers interested in learning more about the direct patient care model. They will discuss the recent legislative updates that have brought this issue to the forefront in Florida.
Further reading per AAFP.org – The direct primary care (DPC) model gives providers a meaningful alternative to fee-for-service insurance billing, typically by charging patients a monthly, quarterly, or annual fee (i.e., a retainer) that covers all or most primary care services including clinical, laboratory, and consultative services, and care coordination and comprehensive care management. Because some services are not covered by a retainer, DPC practices often suggest that patients acquire a high-deductible wraparound policy to cover emergencies. Direct primary care and concierge care are not synonymous. In practices offering concierge care, the patient typically pays a high retainer fee in addition to insurance premiums and other plan obligations (e.g., copays, out-of-pocket expenditures), and the practice continues to bill the patient’s insurance carrier.
In giving consideration to whether healthcare regulations apply to a proposed course of conduct it’s absolutely vital for a pharmacy to know its payor! This is especially so in the context of patient marketing and the various regulatory prohibitions on paying for healthcare referrals. Unfortunately, some pharmacy owners remain a bit mixed up about who the ultimate payor is for the medications they dispense, and, depending on that pharmacy’s billing operations, such mistakes can have devastating consequences.
A large part of this confusion might be attributed to the fact that in most instances, a pharmacy is not billing the ultimate payor directly (unlike a DMEPOS provider that may be directly submitting claims to Medicare Part B), but rather, the pharmacy is billing an intermediary entity called a Pharmacy Benefit Manager (“PBM”), which is usually a commercially run entity (non-government owned) that manages and adjudicates claims on behalf of health insurance plans that cover pharmacy benefits.
There are two criminal cases pending in Palm Beach County that threaten to put a bullet in the heart of healthcare professionals and businesses and also the law practices that advise them. Both State v. Simeone and State v. Kigar have a motion from the State pending before them to block any testimony that the defendants received legal advice concerning a contract entered into by an addiction treatment facility and a sober home. The State alleges that the contract violates the state Patient Brokering Act (PBA) because it was essentially a ruse whereby the addiction treatment facility was just paying for the sober home to refer patients. Now the State wants to make sure that the entire issue of the defendants being advised by counsel never sees the light of day.
How is this possible? How can it be that a client can seek legal counsel, get advise (and presumably follow it), and then be blocked from presenting that evidence? The State argues that the PBA has no wording that requires them to prove intent. And if intent isn’t an element to be proven, the argument goes, then evidence of the client intending not to violate the law by getting advice beforehand is inadmissible!
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.
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.
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.
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.