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.
Has your attorney ever told you to do your best to comply with certain safe harbors to the Federal Anti-Kickback Statute, and you’ll be likely to survive scrutiny under the Florida Patient Brokering Act (the PBA)? If you’ve heard that, it’s time to re-examine that relationship. In the last month, the Patient Brokering Act has been amended, and then interpreted by a court of law in a way that affects all healthcare providers.
The Patient Brokering Act has been used in recent years to prosecute abuses in the addiction treatment industry. Other healthcare providers subject to the act have largely been uninvolved in these prosecutions. However, the PBA has been remolded 4 times in the past 5 years as a means to tailor it to allow for prosecutions of bad actors in healthcare, including addiction treatment. One item should be made clear: the PBA applies to any facility at all that is licensed by the Agency for Healthcare Administration (AHCA) or practitioner licensed by the Department of Health (DOH), including physicians, surgery centers, home health agencies, skilled nursing facilities, hospitals, DME providers, diagnostic imaging facilities, clinical laboratories, pharmacies and many other. During the legislative process, barely any healthcare industry representatives (from any provider group) showed up to any legislative workshops or produced counterbalancing input or language proposals that reflected a broader perspective. read more
The core aspect of EKRA has to do with how to properly compensate marketing personnel who market the services of labs, addiction treatment facilities and recovery homes. For those of you already familiar with existing federal law pertaining to compensation arrangements (e.g. the bona fide employee exception (the “BFE”) and the personal services arrangement and management contract safe harbor (the “PSA”)), the EKRA provisions will look familiar! Key aspects of this law (which has to be read together with similar existing laws) include— read more
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! 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
Telehealth law Florida is constantly evolving The latest example is found with Florida’s Department of Children and Families (DCF) recent proposed rule change which now includes a definition of Telehealth as a delivery system in substance abuse. Telehealth can be used in treatment or prevention services through electronic communications from one site to another. However, it does not include delivery of services using only the audio on a telephone, or e-mails, text messages, fax transmissions, US mail or other parcel service. Proposed Rule 65D-30.0031 (83) Definitions.
Telehealth services can be used in intensive outpatient, day or night treatment, day or night treatment with community housing, outpatient, interventions, aftercare, and prevention. If a substance abuse provider plans on including telehealth services it must submit to DCF detailed procedures outlining which services it intends to provide. The provider will be responsible for the quality of the equipment and technology used in the telehealth service. Proposed Rule 65D-30.004 (20) Common Licensing Standards. read more
Before doing business in Florida, an entity providing substance abuse marketing services must be licensed by Florida’s Department of Agriculture and Consumer Protection. This includes includes either telephone solicitation from a location in Florida or solicitation from other states or nations for substance abuse and addiction treatment centers located in Florida.
As of November 27, 2017, only the following entities are licensed by the State of Florida to provide marketing services to substance abuse and addiction treatment centers:
A Way and a Means, LLC (Delray Beach, Florida)
Addiction International Holdings, LLC d/b/a The Addiction Advisor d/b/a The Recovery Miracle (Boca Raton, Florida)
Advanced Recovery Systems, LLC (Winter Park, Florida)
Bandwidth Interactive Company d/b/a Local Management (Boca Raton, Florida)
Delphi Behavioral Health Group, LLC (Fort Lauderdale, Florida)
Freedom From Addiction, LLC (Miami Beach, Florida)
Infoworx Direct, LLC d/b/a Addiction Hope and Help Line (Boca Raton, Florida)
Invigorate Solutions, LLC d/b/a Local Management (Boca Raton, Florida)
Meridian Treatment Solutions, LLC (Lauderdale by the Sea, Florida)
NPA Consulting Group, LLC (Pompano Beach, Florida)
Palm Partners, LLC (Palm Springs, Florida)
Parent Team, LLC (Santa Rosa, California)
Pryme Time Media, LLC (Sunrise, Florida)
R360, LLC (Fort Lauderdale, Florida)
Redwood Recovery Solutions, LLC d/b/a com (Riviera Beach, Florida)
Ring2Media, LLC (Westport, Connecticut)
Rybchinskiy Inc. (Boynton Beach, Florida)
Sober Network, Inc. (Delray Beach, Florida)
The Addiction Network, LLC (North Miami, Florida)
True Choice Health Group Limited Liability Company (Pompano Beach, Florida)
United Addiction Specialists, LLC (Hollywood, Florida)
USR Holdings, LLC (Coconut Creek, Florida)
It is a third degree felony for: any person to work for an entity that does not have a current and valid license; or for any entity to invite telephone calls or other communications with a substance abuse marketer who is soliciting clients without a current and valid substance abuse marketing license; or for any person or entity to solicit without a license; or for any person who otherwise violates the law requiring licensure either directly or indirectly. Any person who is convicted of a second or subsequent violation commits a felony of the second degree.
Passage of the new and comprehensive Florida addiction treatment industry legislation (CS/CS/HB 807) will send addiction treatment facility management relationships back to the drawing board. Prior to the new law, some DCF licensed facilities were managed by management companies, some of which were owned by people who either did not qualify to be on the DCF license or who did not want to be visible on the license.
The new addiction treatment law requires all such arrangements to be reconsidered. Here’s why: There are several sections in the new law where management is the subject of intensive focus. Newly created 397.410 requires DCF to establish minimum licensure requirements for each service component limited in part to the number and qualifications of all personnel, including management. Newly created 397.415(1)(d)1 authorizes DCF to deny, suspend or revoke licensure of any license based on a “false representation of a material fact in the licensure application or omission of any material fact from the application.” Finally, 397.415 creates an entire category of potentially punishing fines and, in some cases, exposure to criminal prosecution.
The new law will create heavy regulatory suspicion for any non-transparent management relationship, even a third party relationship. Worse, it’s conceivable that any suspicious or arguably noncompliant relationship could form the basis for recoupment by insurers. When the state Health Care Clinic Law was created some years ago, payers took advantage of situations where facilities that required a license but didn’t have one. Under a threat of insurance fraud (e.g. an unlicensed healthcare facility receiving compensation for services), some payers were able to extract huge recoupments.
Any DCF licensed facility with a third party management relationship needs to reconsider it in light of the new addiction treatment law. Moreover, all interested parties should pay close attention to (and monitor and participate in) the new law’s rulemaking process which began at the end of June.
CLICK HEREfor: SUBSTANCE ABUSE MARKETING SERVICE PROVIDER LICENSE APPLICATION
With the opioid epidemic in South Florida at crisis levels, there is an increasing demand on local hospital emergency departments for screening and evaluations of drug overdoses, considered a medical emergency. Addiction treatment law evolves with EMTALA updates. Many patients receiving substance abuse treatment in this community are coming from out-of-state. Many are young, under 35 years and a majority receive outpatient services. Overdoses are occurring more frequently as patients deliberately misuse opioid prescriptions such as Fentanyl or an illicit drugs such as heroin. If the patient possesses and or uses an illicit drug while in treatment, the policy in many facilities is to terminate treatment and discharge the patient. But if the patient has overdosed, the facility will place a call to 911 and that patient will end up with a visit to a local emergency department. A discharged patient will often continue using and end up in the emergency department, taken there by paramedics or some other individual.
Evolution of EMTALA
Local emergency departments now play a pivotal role in the next steps that an overdosed patient may take. Is the patient receiving their EMTALA rights (Emergency Medical Treatment and Labor Act), a federal law requiring anyone coming to a hospital emergency department to be screened and examined? If an emergency medical condition exists, treatment is provided to relieve or eliminate the emergency medical condition within the service capability of the hospital, a difficult task with substance abuse. read more
One of the biggest challenges faced by addiction treatment providers today, especially in Palm Beach County, Florida, arises in the context of unprecedented pressure by law enforcement via the Sober Home Task Force, newspapers and insurers. The threat of being targeted by law enforcement is an enormous thing in itself. Add to that the mainstream media’s insatiable desire for readers, the industry’s drop into insurer red flagging and recoupment, the political football nature of addiction and addiction treatment, and treatment providers can lapse into a state of paralyzed tunnel vision, a sort of mass hypnosis. Here’s the problem: providers dealing with the current compliance crisis environment have a lot to lose if they take their eye off the bigger picture. The more absorbed they become in “crisis mode,” the more likely they will miss important addiction treatment compliance details in an increasingly regulated and changing industry. Losing the ability to see the entire picture (and trends) and quickly adapting to it can have costly (and even deadly) consequences.
The addiction treatment industry is like any other healthcare provider—enormously and increasingly regulated, highly scrutinized and always dynamic. The moment it took on features of traditional healthcare (e.g. lab and physician services), it left the relatively warm and fuzzy comfort of behavioral health providers, sorta. “Sorta” because medical behavioral health (e.g. psychology and counseling) has not had it easy in the past 10 years, as it came under crushing price compression with managed care driven networks and other price cutting middlemen that have often been owned or controlled by insurance companies. Addiction treatment providers in the pure behavioral health space were “saved” from all this till about three years ago because they were out of network and not the focus of insurer driven price cuts. As payors (and their price cut incentivized middle men) looked for more ways to drive up profits, the competitive and disorganized addiction treatment sector became a natural (and unprepared) sector to hit. And they hit it hard! Clearly, the Perfect Storm. Addiction treatment providers now have no option but to learn to swim hard and fast in the ever changing river of the healthcare business industry. read more
Concepts that drive sober home relationships like Anti-Kickback Statute, Patient Brokering Act and Safe Harbor have become ingrained in the minds of nearly every addiction treatment provider’s thought process, especially in Florida with the development of the Sober Home Task Force. Providers now seem to fully embrace ideas like–
There’s a federal law (the Anti-Kickback Statute, the “AKS”) that can bring criminal liability for marketing done incorrectly;
There’s a state law, the Florida Patient Brokering Act (“PBA”), that can do the same;
Complying with the federal safe harbors and the bona fide employee exception is important, even when there are no state or federal healthcare program dollars involved;
Paying anyone for marketing, not just on a commission based sales model, without fully appreciate the applicable laws is dangerous, costly and invites criminal inquiries and liability; and
Achieving compliance with applicable federal law should be part of any recovery business’ overall compliance plan.
Recovery providers must become familiar with not only the AKS and state restrictions like the PBA, but also the law’s permitted examples, so called “Safe Harbors,” which specify specifically permitted arrangements (42 CFR 1001.952). The “personal services arrangement and management contract” Safe Harbor, for instance, has particular application in the area of marketing, as does the AKS exception for “bona fide employment arrangements,” which apply to “bona fide” W-2 employees (entailing direction, supervision and control), but not independent contractor relationships. read more