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Clinical Laboratory Licensure: Florida Repeals State Licensure

June 5th, 2018 by

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). read more

Role of Laboratories in Determining Medical Necessity

February 12th, 2018 by

medical necessity laboratoryBy: Karina Gonzalez 

A recent whistleblower action (by UnitedHealthcare Medical Director, Tina Groat) against Boston Heart (laboratory) was brought under the federal False Claims Act and deals with medical necessity issues.  As part of the analysis, the Court reviewed whether a laboratory [or supplier like DME] must determine the medical necessity of the ordering physician.  Boston Heart contended that a doctor, not a laboratory, determines the medical necessity of a test.  Boston Heart argued that when a laboratory bills Medicare for testing ordered by a physician, it must only maintain documentation it receives from the ordering physician and ensure that the information that it submitted with the claim accurately reflects the information it received from the ordering physician. It noted that the CMS-1500 form certification does not require that the billing lab to make the medical necessity determination. The lab certifies that the services are medically necessary by relying on the clinical determination of the treating physician. read more

Protecting Your License Against Adverse Action

October 12th, 2017 by

election of rightsBy: Susan St. John

If you have ever been the recipient of a Florida state agency’s (i.e. Department of Health, AHCA, etc.) notice regarding an adverse action, such as a Notice of Intent to Deny, licensure application, renewal or change of ownership, you probably received an Election of Rights form along with the agency’s notice. The Election of Rights form must be completed and returned to the agency within 21 days of receiving the agency’s notice. In completing the Election of Rights form, you are given three options to choose from in deciding how you want to respond to the agency’s notice.

Under Option One you admit to the allegations of facts and law contained in the agency’s notice of intended action and waive the right to object and have a hearing. This is akin to an admission of guilt, that the agency is right in its decision, and you agree to a final order that supports the agency’s actions, including imposition of fines and punishment against you. Option One is generally not in your best interest. read more

The 7 Essential Elements of an Effective Compliance Plan

April 2nd, 2015 by

020513-Succession-Planning-ChecklistBy: Jackie Bain

When a healthcare provider cares for a patient, many times, the provider will set out directives for the patient to follow in order to live a healthier life.  These changes may include changes in lifestyle, eating habits, and obedience in taking medications.  A patient’s compliance with these directives instructs the provider on how to care for the patient in the future.  A patient who does not follow these directives may suffer health consequences.

Similarly, the government sets out legal regulations for healthcare providers.  The government expects healthcare providers to comply with its regulations, and providers who don’t can suffer consequences as a result.  The regulations governing health care providers are vast and dynamic.  In order to keep abreast of the changes in law, and to evidence an intent to comply with law, healthcare providers should strongly consider instituting compliance programs in their businesses.

Compliance with healthcare laws is important.  Any number of consequences can result in the event that a healthcare provider is out of compliance—the most devastating being that the Department of Health and Human Services Office of the Inspector General (“OIG”) has the authority to exclude healthcare providers from participation in Medicare and other federal health care programs.  Ignorance of the law does not absolve a healthcare provider of liability. read more

Medical Director Supervision Restrictions

February 17th, 2015 by

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.  read more

OIG Special Fraud Alert: Laboratory Payments to Referring Physicians

June 26th, 2014 by

OIG crestThe Office of Inspector General of the Department of Health and Human Services today issued a Special Fraud Alert pertaining to relationships between laboratories and referring physicians.  Payments from labs to physicians who refer were targeted in the Alert.  The Alert also reiterates their suspicion of so-called “carve out” compensation relationships where state and federal healthcare program dollars are removed from the payment formula (which was previously addressed last year in Advisory Opinion 13-03).  While the Alert does not add anything new to the government’s view of such relationships, it does underscore the very suspect view the OIG has of payment relationships between labs and the physicians who refer to them.  Careful compliance with the Personal Services and Management Contracts Safe Harbor continues to be a core concern.

Point of Care Test Cups Held to be a Prohibited Benefit to Physicians Who Could Not Otherwise Bill for Them

June 18th, 2014 by

pee in a cupBy: Jackie Bain

When a physician cannot bill for test results, and a company offers to give that physician those test results for free, a Florida Federal Court has ruled that the company is offering the physician prohibited remuneration.  On May 5, 2014 the Middle District of Florida granted partial summary judgment on the latest motion in a contentious litigation between Ameritox Ltd. and Millennium Laboratories, Inc.  Ameritox and Millennium are competitors and clinical laboratories that screen urine specimens for the presence of drugs.

Millennium provided free point of care testing cups to physicians, who use the cups for initial testing and then return the cups back to Millennium for confirmation tests.  Physicians do not bill patients or insurance companies for the point of care tests. read more

Toxicology Labs Owned by Referral Sources – Is it Really so Wrong?

April 15th, 2014 by

Notebook and lens concept

By: David Hirshfeld & Jeff Cohen

Lately we’ve noticed an uptick in criticism of toxicology labs that are owned by the substance abuse treatment programs and recovery residences that refer to them.  Sadly, this criticism seems to be coming from within the addiction and recovery industry itself.  In addition to being absolutely necessary for substance abuse treatment, toxicology screens have become a meaningful source of revenue that helps to fund treatment programs and scholarships for those who cannot afford to pay the full cost of treatment.  We cannot understand why the substance abuse treatment industry would want to help pull the rug out from under itself, but that seems to be what is occurring.  Under the current state of Florida law, toxicology labs can be owned by their referral sources without much risk if that arrangement is properly structured. read more

Florida Recovery Residences Caught in a Perfect Storm

March 4th, 2014 by

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.

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Florida Clinical Labs Must Now Give Patients Direct Access to Their Laboratory Test Results

February 11th, 2014 by

lab testingBy: David Hirshfeld 

In an effort to help individuals access their health information so that they can become more actively involved in managing their own health care, several agencies within the Department of Health and Human Services promulgated a rule that modifies the Clinical Laboratory Improvement Amendments (“CLIA”) and the Health Insurance Portability and Accountability Act (“HIPAA”) in a way that supersedes Florida State laws governing the disclosure of laboratory test results directly to patients.

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