The placement of laboratory personnel in the physician’s office has been a routine arrangement in healthcare. The arrangement has been permitted under federal law, with limitations, however various states have prohibited this arrangement. Florida has restricted this relationship by statute.
Federal regulations have been construed to allow the placement of a phlebotomist or specimen collector in the physician’s office and asserts that the placement does not necessarily serve as an inducement prohibited by the anti-kickback statute. The OIG has previously stated when permitted by state law, the statute is implicated when the phlebotomist performs additional tasks that are normally the responsibility of the physician’s office staff. The tasks can include taking vital signs or other nurse functions, testing for the physician’s office laboratory, or performing clerical services. Where the phlebotomist performs clerical or medical functions not directly related to the collection or processing of laboratory specimens, a strong inference arises in that he or she is providing a benefit in return for the physician’s referrals to the laboratory. (See OIG Special Fraud Alert, December 19, 1994).
The Florida law states “It is unlawful for any clinical laboratory to 1. Provide personnel to perform any functions or duties in a health care practitioner’s office or dialysis facility for any purpose, including for the collection or handling of specimens. Directly or indirectly through an employee, contractor, independent staffing company, lease agreement, or otherwise, unless the laboratory and the practitioner’s office, or dialysis facility, are wholly owned and operated by the same entity. 2. Lease space within any part of a health care practitioner’s office or dialysis facility for any purpose, including for the purpose of establishing a collection station where materials or specimens are collected or drawn from patients” (FS 4546.054(3)(b).
The Florida law specifically prohibits a lab from placing personnel in a provider’s office and prohibits laboratories from leasing space within a physician’s office for any purpose. A violation of the law is considered patient brokering and is punishable as provided under FS 817.505. The violation is a felony and includes the potential for a monetary fine. The prohibition of laboratory personnel in the providers office was added to FS 456.054 in 2018. Prior to 2018, the lab personnel prohibition was contained in FS 483.245, which has since been repealed. The significance of the change in the law should not be overlooked. The prior violation was a monetary penalty not to exceed $1,000. The current law makes the violation a criminal felony plus a monetary fine. Any reliance on the outdated version would surely be misplaced. It is recommended to conduct a state-by-state analysis of the laws regarding the limitation and or restriction of lab personnel in the physician’s office as the laws are constantly changing. States like New York, New Jersey, Pennsylvania, and California have all had laws limiting or prohibiting lab personnel in the physician’s office that the laboratory should be aware of prior to undertaking the placement of lab personnel.
The relationship between the laboratory and the physician’s office can be influenced by the limitation and or restriction of lab personnel in the doctor’s office. It is not uncommon for the doctor and staff to be unaware of the restriction and its consequences. The laboratory and the physician’s office may both face disciplinary and criminal action for the violations of state law, therefore it is vital for both the laboratory and physician’s office to both be advised of the law regarding their relationship,