Clinical Laboratory Licensure: Florida Repeals State Licensure

clinical laboratory law

clinical laboratory lawBy: Karina Gonzalez

Effective July 1, 2018, Florida’s recent legislation SB 622 repeals the entirety of Chapter 483, Part I of the Florida statutes, and removes the state licensure requirement for clinical laboratories operating in-state and out-of-state. Section 97 of SB 622, approved by the Governor on March 19, 2018, repeals the entirety of Chapter 483, Part I of the Florida statutes, and so eliminates section 59A-7.024(1).Continue reading

Beware The Hypnosis of Crisis

By: Jeff Cohen

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.Continue reading

Recovery Residence Law Set to Take Effect in 2016

florida health care attorneyBy: Jacqueline Bain

Several clients have inquired in the past few weeks about the new Florida law regarding recovery residences, or sober living facilities. Implementation of the new law has been slow, leaving a lot of questions unanswered and room for opinions to be taken as facts.

Many have asked us if recovery residences are required by law to obtain certification. It is not mandatory for all sober homes to become certified prior to July 1, 2016. However, as of that date, a DCF-licensed substance abuse treatment facility may not refer a current or discharged patient to a recovery residence unless any of the following applies:

  • the recovery residence holds a valid certificate of compliance or
  • the recovery residence is owned and operated by a licensed service provider or
  • the recovery residence is a licensed service provider’s wholly owned subsidiary.

The term “refer” means to inform a patient by any means about the name, address, or other details of the recovery residence. The effect of the law is to squeeze sober homes into obtaining certification if they are not owned and operated by a DCF-licensed treatment provider.Continue reading

Medical Director Supervision Restrictions

so 2014By: Karina Gonzalez

Medical Directors are used in an administrative capacity to oversee all medical services and care, specifically referring to substance abuse programs and services.  Increasingly, commercial healthcare plans are targeting their role in addictions treatment facilities and denying payment of claims based on audit findings that Medical Directors in Florida may be responsible for far too many treatment facilities and too many patients.

Does Florida have any specific requirements or published guidance on the number of treatment facilities or number of patients for which responsibility falls to the Medical Directors in addictions treatment?

Florida’s Administrative Code directed to substance abuse programs and services does not have any directive which talks about a restriction on the number of facilities or patients recommended for oversight by a Medical Director.  It specifies that addictions receiving facilities, detoxification, intensive inpatient treatment, residential treatment, day or night treatment with host homes and medication and methadone maintenance treatment must designate a Medical Director who oversees all medical services. This Medical Director must hold a current license in the state of Florida. Continue reading

Standing Orders in Drug Treatment Programs: How to Avoid Waving a Red Flag

so 2014By: Karina P. Gonzalez

Medical necessity is the driving force for the payment of any service, but is especially worth noting when discussing laboratory testing. Standing Orders for urine drug testing in residential treatment settings are not prohibited, per se, but this practice must be built upon detailed policies and procedures that are precisely followed and are directed to individual patient needs.

The following conditions may help to determine whether Standing Orders are appropriate in a residential treatment setting:Continue reading

Florida Recovery Residences Caught in a Perfect Storm

sober home keyBy: David Hirshfeld

A confluence of forces brought about by lawmakers, insurance companies and regulators have caught recovery residences in the eye of a perfect storm here in Florida. Senate Bill 582 proposes to mandate that Florida sober homes and their owners be registered, inspected and licensed; but really, that bill may not be necessary due to other factors.  Florida’s Department of Children and Families (“DCF”) has been using Section 65D-30.007 of its Administrative Code to require that sober homes be licensed for Residential Treatment if any resident at that sober home is also a patient at a licensed treatment program owned by the same person or entity that owns the sober home.

Continue reading

Integrating Clinical Labs Into Substance Abuse Treatment Programs: A Whole Lot of Fuss Over Pee in a Cup

pee in a cupBy: David Hirshfeld

The recent and drastic cut in reimbursement for point-of-care urinalysis has caused just about all of our substance use treatment program clients to consider integrating clinical laboratories into their enterprise models.  These programs long for a way to restore the revenue stream that urinalysis had generated.  For sober living programs, the lost revenue often means the difference between profitability and breaking even.  For more comprehensive programs, the lost revenue can hinder their ability to expand or provide scholarships to those who could not otherwise afford treatment.  Regardless of their specific goals, our clients are amazed and dismayed at the regulatory minefield that awaits them; especially since their lab consultant (read “reagent salesperson”) makes the process sound so simple.Continue reading

Drug & Alcohol Treatment Facilities Need to Focus on Licensure

Many drug and alcohol treatment facilities see continuity of care and income opportunities in providing qualitative (and even quantitative) toxicology screening to make sure they know (1) what their residents/patients are taking, and (2) in what quantities.  Facilities need to make sure they know that federal and state law will view them as a clinical lab, even when they are simply taking urine and using cups.  CLIA will require they obtain “waived” status (since dipsticks are in that category).  Facilities also need to examine whether state licensure (as a “Healthcare Clinic”) is also required.  Chapter 400, Florida Statutes requires any entity to obtain a healthcare clinic license if (a) healthcare services are provided, and (b) claims for those services are submitted.  Even though most facilities are out of network, most do submit claims to insurance carriers and hence implicate the state healthcare clinic license law (which is different from the CLIA law).

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