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Currently there are 25 “safe harbors” to the federal anti-kickback statute. These safe
harbors outline acceptable contractual and business arrangements which, if followed,
do not lead to a violation of the federal anti-kickback statute. The anti-kickback statute
may be found at 42 U.S.C. § 1320a-7b and the anti-kickback safe harbors may be
found at 42. C.F.R. 1001.952(a)-(y).
12.1.3 Federal False Claims Act
The False Claims Act prohibits knowingly submitting for payment or reimbursement a
claim known to be false, making or using a false record or statement material to a false
or fraudulent claim or engaging in a conspiracy to commit fraud by improper
submission of a false claim, and concealing, improperly avoiding, or decreasing an
obligation to pay the government. The False Claims Act allows people who are not
affiliated with the government to file claims against federal contractors accused of
committing fraud against the government, and therefore the U.S. taxpayers. This is
generally referred to as a Qui Tam or whistleblower lawsuit.
12.2 Florida Law
12.2.1 Patient Self-Referral Act of 1992
Under the provisions of Florida Statutes § 456.053, “A healthcare provider may not
refer a patient for the provision of designated health services to an entity to which the
healthcare provider is an investor or has an investment interest.” This statute is similar
to the federal Stark Law; however, there are specific differences between the federal
and Florida laws. Most importantly, the Stark Law is limited to claims submitted to
federal healthcare programs such as Medicare. The Florida Self-Referral Act applies to
all claims submitted to all payers by healthcare practitioners in the state.
Designated health services under the statute include clinical laboratory services,
physical therapy services, comprehensive rehabilitative services, diagnostic imaging
services and radiation therapy services. It is also unlawful for a healthcare provider to
refer a patient for the provision of any other healthcare item or service to an entity in
which the healthcare provider is an investor unless the investment meets certain
criteria. The term “healthcare provider” is defined as any licensed, medical
osteopathic, chiropractic or podiatric doctor, persons licensed under The Optometry
Practice Act and persons licensed as dentists or related practitioners under Chapter
466 of the Florida Statutes.
Exceptions to the self-referral prohibition include orders, recommendations and plans
of care by radiologists for diagnostic imaging services, and physicians specializing in
radiation therapy for such services; medical oncologists for intravenous drugs and
solutions to treat cancer and related complications; cardiologists for cardiac
catheterization, pathologists for diagnostic clinical laboratory services and pathologic
examination services if furnished under the supervision of a pathologist pursuant to a
consultation requested by another physician; healthcare providers for services
provided solely to their own patients that are provided under the direct supervision;
ambulatory surgical center services; urologists for lithotripsy services; dentists for
dental services performed by employer/contractor of the dentist or dental group;
physicians for infusion therapy services to a patient of the physician or the physicians
group practice; nephrologists for renal dialysis services and supplies except for
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