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PRIOR PRINTER'S NO. 1567
PRINTER'S NO. 1900
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
1443
Session of
2021
INTRODUCED BY HERSHEY, COX, KLUNK, ROZZI, SNYDER, STEPHENS,
ZIMMERMAN AND ROAE, MAY 20, 2021
AS REPORTED FROM COMMITTEE ON HEALTH, HOUSE OF REPRESENTATIVES,
AS AMENDED, JUNE 23, 2021
AN ACT
Amending the act of September 26, 1951 (P.L.1539, No.389),
entitled "An act defining clinical laboratory; regulating the
operation of the same; requiring such laboratories to obtain
permits, and to be operated under the direct supervision of
qualified persons; imposing certain duties upon the
Department of Health; and providing penalties," providing for
advertisements for laboratory tests.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The act of September 26, 1951 (P.L.1539, No.389),
known as The Clinical Laboratory Act, is amended by adding a
section to read:
Section 13.3. Advertisements for Laboratory Tests.--(a) A
clinical laboratory certified under section 353 of the Public
Health Service Act (58 Stat. 682, 42 U.S.C. § 263a) or AND a
clinical laboratory operating under this act may directly or
indirectly advertise or solicit business for diagnostic
laboratory testing or ancestry testing if all of the following
apply:
(1) The FOR DIAGNOSTIC TESTING, THE testing is ordered by a
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health care practitioner LICENSED IN THIS COMMONWEALTH or
another person otherwise authorized by the laws of this
Commonwealth to order the test.
(2) The testing is performed by the clinical laboratory.
(3) The clinical laboratory is a covered entity or a
business associate of a covered entity for the purpose of
compliance with THE Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191, 110 Stat. 1936)
and the Health Information Technology for Economic and Clinical
Health Act (Public Law 111-5, 123 Stat. 226-279 and 467-496).
(4) The clinical laboratory does not make a claim about the
reliability and validity of the testing that is inconsistent
with the testing proficiency standards under section 353 of the
Public Health Service Act.
(5) THE CLINICAL LABORATORY SHALL DISCLOSE THAT THE
DIAGNOSTIC LABORATORY TEST OR PROCEDURE MAY OR MAY NOT BE
COVERED BY HEALTH INSURANCE.
(b) The department may prohibit the use of a clinical
laboratory's advertisement or solicitation of business for
diagnostic laboratory testing or ancestry testing under
subsection (a) or impose a penalty authorized under section
14(b) if the department determines any of the following:
(1) The diagnostic laboratory testing or ance stry testing
poses a public threat.
(2) The diagnostic laboratory testing or an cestry testing is
not in compliance with this section.
(c) As used in this section, the following words and phrases
shall have the meanings given to them in this subsection unless
the context clearly indicates otherwise:
"Ancestry testing." Y-chromosome mitochondrial DNA or
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autosomal DNA testing for the detection and reporting of genetic
evidence of parental lineage and generic ethnicity.
"Business associate." As defined in 45 CFR § 160.103
(relating to definitions).
"Covered entity." As defined in 45 CFR § 160.103.
"Diagnostic laboratory testing." The term includes genetic
testing or procedures for the purpose of screening, diagnosing,
managing or treating a physical or mental condition or disease.
THE USE OF SPECIALIZED APPARATUS, EQUIPMENT AND METHODS, FOR THE
PURPOSE OF SCREENING AND OBTAINING DIAGNOSTIC INFORMATION FROM
ANY MATERIAL ORIGINATING FROM THE HUMAN BODY TO AID OR ASCERTAIN
A PERSON'S STATE OF HEALTH. THE TERM DOES NOT APPLY TO GERMLINE
GENETIC OR GENOMIC TESTING DONE IN CONNECTION WITH THE ANALYSIS,
DIAGNOSIS OR PREDICTION OF HUMAN DISEASES.
Section 2. All regulations and parts of regulations are
abrogated insofar as they are inconsistent with this act.
Section 3. This act shall take effect immediately.
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