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CHAPTER 12.  HEALTHCARE


                   Healthcare
                   Robert E. Slavkin, Esq. | (407) 419-8438 | robert.slavkin@akerman.com

                   What follows is an outline of certain laws which must be considered by providers and other participants
                   in the healthcare industry in Florida, focusing primarily on the anti-referral and anti-fraud and abuse
                   statutes. A brief discussion of licensing requirements in Florida also follows.   This outline is by no
                   means meant to be an exhaustive discussion on what are highly complex laws regulating the healthcare
                   industry in Florida. Users of this Guide are advised to consult Lex Mundi-affiliated healthcare counsel
                   with specific questions regarding practitioner license matters, operation matters and other healthcare
                   practice and operations questions with respect to transaction-specific matters.

                   12.1  Federal Law

                          12.1.1 Physician Self-Referral Prohibition (Stark)
                                 The Physician Self-Referral Prohibition, commonly referred to as the “Stark Law,”
                                 generally provides that, subject to certain exceptions, a physician may not refer
                                 patients for Medicare-covered “designated health services” to any entity with which the
                                 physician (or an immediate family member of the physician) has a financial relationship,
                                 and the entity may not bill for any services provided as a result of the prohibited referral
                                 (see 42 U.S.C. § 1395nn. See also 42 C.F.R. § 411.351-357). A “designated health
                                 service” includes, among other things, inpatient and outpatient hospital services,
                                 clinical laboratory services, physical therapy services, occupational therapy services,
                                 radiology services, radiation therapy services and supplies, durable medical equipment
                                 and supplies, home health services, and outpatient prescription drugs.  The full list of
                                 designated health services may be found at 42 U.S.C. § 1395nn.

                                 The Stark Law contains approximately thirty-five (35) exceptions.  These exceptions
                                 outline acceptable financial relationships which may occur that otherwise could be
                                 perceived to be potential physician self-referrals.  These exceptions can be grouped
                                 into the different categories as follows:  ownership and investment interests, or
                                 compensation arrangements.  These exceptions include personal service contracts,
                                 non-monetary compensation, bona fide employment agreements, certain compliance
                                 training contracts, and rent for facilities, equipment and personnel.

                          12.1.2 Federal Anti-Kickback Statute

                                 The Federal Anti-Kickback Statute, among other things, prohibits any person from
                                 “knowingly and willfully” paying or offering any remuneration in exchange for or to
                                 induce the referral of any item or service covered by a federal healthcare program.
                                 The statute has been broadly interpreted by federal courts to prohibit any payment if
                                 any one purpose of the payment is to induce the referral of covered goods or services,
                                 irrespective of whether there are other, legitimate business purposes for the payment.
                                 Conditions under the statute constitute a felony and may result in a fine of $25,000 per
                                 offense plus imprisonment of up to 5 years or both.  Additionally, there is a possibility
                                 of civil exclusion from the federal healthcare programs for 5 years or more and civil
                                 monetary penalties.



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