Home Table of Contents

§ 2163.1. Unlawful conduct

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: December 18, 2013

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 21. Clinical Laboratory Act (Refs & Annos)
Effective: December 18, 2013
35 P.S. § 2163.1
§ 2163.1. Unlawful conduct
Currentness
(a) Except as provided in section 13,1 it shall be unlawful for a person or clinical laboratory regardless of whether the person or clinical laboratory is located in this Commonwealth to solicit, collect, process, handle, receive, accept, deliver or transmit, by mail or otherwise, material originating from the human body on behalf of a person or clinical laboratory not in possession of a permit under this act, except that this section may not prohibit a clinical laboratory holding a permit from the department from referring a specimen to another clinical laboratory holding a permit from the department or to a clinical laboratory issued a certificate or accreditation in conformity with section 353 of the Public Health Service Act (58 Stat. 682, 42 U.S.C. § 263a) and related State laws.
(b) It shall be unlawful for a person or clinical laboratory regardless of whether the person or clinical laboratory is located in this Commonwealth or maintains a permit issued by the department to:
(1) Pay or receive a commission, bonus, kickback or rebate or engage in a split-fee arrangement in any form with a health care provider or health care practitioner, either directly or indirectly, for patients or their specimens referred to any clinical laboratory operating within this Commonwealth or testing a specimen accepted or collected within this Commonwealth.
(2) Lease or rent space, shelves or equipment or other services within a health care provider's office or health care practitioner's office, including the leasing or renting of space within a part of a health care provider's or health care practitioner's office, for the purpose of establishing a collection station.
(3) Directly or indirectly provide through employees, contractors, an independent staffing company, lease agreement or otherwise, personnel to perform functions or duties in a health care provider's or health care practitioner's office, for any purpose regardless of whether fair market value is offered or given, including for the collection or handling of specimens, unless the clinical laboratory and the health care provider's office or health care practitioner's office are wholly owned and operated by the same entity.
(4) Permit the placement of paid or unpaid personnel to perform services, including, but not limited to, specimen collection, processing the specimen or packaging or handling services or genetic counseling, in a health care provider's or health care practitioner's office regardless of whether fair market value is offered or given.
(c) This section does not preclude a clinical laboratory from owning or investing in a building in which space is leased or rented for adequate and fair consideration to health care providers or health care practitioners.

Credits

1961, Aug. 4, P.L. 920, § 13.1, added 1972, Dec. 6, P.L. 1388, No. 297, § 4, effective July 1, 1972. Amended 2013, Dec. 18, P.L. 1232, No. 122, § 3, imd. effective.

Footnotes

1
35 P.S. § 2163.
35 P.S. § 2163.1, PA ST 35 P.S. § 2163.1
Current through Act 10 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
End of Document