Category Archives: clinical laboratory license

The 7 Essential Elements of an Effective Compliance Plan

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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. Continue reading →

Medical Director Supervision Restrictions

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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 →

OIG Special Fraud Alert: Laboratory Payments to Referring Physicians

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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

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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. Continue reading →

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

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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. Continue reading →

Florida Recovery Residences Caught in a Perfect Storm

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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

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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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AHCA Alert – File Now!

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alert redIn a recent Alert, Florida’s Agency for Health Care Administration announced that Florida Medicaid is in the throes of updating its Provider General Handbook, and will soon require new enrollees to provide either a copy of their Health Care Clinic License or a Certificate of Exemption from the clinic licensure requirement.  Once Handbook changes have been adopted, Florida Medicaid will roll-out similar requirements for existing providers to produce either Licenses or Certificates of Exemptions.

Up until now there really has not been a compelling reason for an exempt provider to obtain a Certificate of Exemption.  We urge our clients to file for their Certificates of Exemption in an effort to avoid what is likely to be an onslaught at AHCA’s licensing bureau.”

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

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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 →