Florida physicians are being approached to become owners of pharmacies to which they may refer, often compounding pharmacies, but may be unaware of the regulatory issues involved. Physicians need to be aware of the core laws that apply, which include the Florida Patient Self Referral Act (FPSRA), the Florida Anti Kickback Statute, the Patient Brokering Act and the Federal Investment Interest Safe Harbor.
Under the FPSRA, absent a statutory exception, a health care provider, including a medical doctor and various other types of providers, may not refer a patient for the provision of designated health services or “any other health care item or service” to an entity in which the health care provider is an investor. Pharmaceutical services are not a “designated health service” under the FPSRA. However, the referral restrictions under the FPSRA apply also to referrals for “any other health care item or service”, arguably encompassing referrals for pharmaceutical services. Fla. Stat. 456.053(3)(c), 456.053(5).
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Under the FPSRA, absent a statutory exception, a health care provider, including a medical doctor and various other types of providers, may not refer a patient for the provision of designated health services or “any other health care item or service” to an entity in which the health care provider is an investor. Pharmaceutical services are not a “designated health service” under the FPSRA. However, the referral restrictions under the FPSRA apply also to referrals for “any other health care item or service”, arguably encompassing referrals for pharmaceutical services. Fla. Stat. 456.053(3)(c), 456.053(5).
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