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EXPLANATION: CAPITALS INDICATE MATTER ADDED TO EXISTING LAW.
[Brackets] indicate matter deleted from existing law.
*sb0078*
SENATE BILL 78
J1 6lr1485
(PRE–FILED)
By: Senator Ellis
Requested: October 30, 2025
Introduced and read first time: January 14, 2026
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
Public Health – Prostate–Specific Antigen Testing 2
(Protect Our Prostate Act) 3
FOR the purpose of requiring certain providers and laboratories to provide certain written 4
information to patients receiving prostate–specific antigen testing; requiring clinical 5
laboratories that administer prostate –specific antigen tests to follow certain 6
disclosure requirements, use standard calibration for testing assays and report test 7
results in a standard manner, make certain disclo sures to ordering providers, and 8
follow guidelines from certain organizations; and generally relating to 9
prostate–specific antigen testing. 10
BY adding to 11
Article – Health – General 12
Section 17–801 through 17–803 to be under the new subtitle “Subtitle 8. 13
Prostate–Specific Antigen Testing” 14
Annotated Code of Maryland 15
(2023 Replacement Volume and 2025 Supplement) 16
Preamble 17
WHEREAS, Prostate–specific antigen testing, while an important tool for the early 18
detection of prostate cancer, is not a definitive diagnostic tool and can produce misleading 19
results that could lead to invasive biopsies or overtreatment; and 20
WHEREAS, Patients undergoing prostate –specific antigen testing should be 21
adequately informed of the potential costs associated with the testing and the implications 22
surrounding false–positive results; now, therefore, 23
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 24
That the Laws of Maryland read as follows: 25
2 SENATE BILL 78
Article – Health – General 1
SUBTITLE 8. PROSTATE–SPECIFIC ANTIGEN TESTING. 2
17–801. 3
(A) IN THIS SUBTITLE THE FOLLOWING WORDS HAVE THE MEANING 4
INDICATED. 5
(B) “CLINICAL LABORATORY” MEANS A FACILITY IN WHICH LABORATORY 6
TESTING IS PERFORMED ON HUMAN SPECIMENS FOR DIAGNOSIS, PREVENTION, OR 7
TREATMENT OF DISEASE. 8
(C) “PROSTATE–SPECIFIC ANTIGEN TES T” MEANS A LABORATORY B LOOD 9
TEST THAT MEASURES THE CONCENTRATION OF PROSTATE–SPECIFIC ANTIGEN FOR 10
USE IN DIAGNOSING A PROSTATE DISORDER. 11
17–802. 12
(A) IF A PROVIDER ORDERS A PROSTATE–SPECIFIC ANTIGEN TES T FOR A 13
PATIENT DURING A PATIENT ENCOUNTER, THE PROVIDER SHALL PROVIDE WRITTEN 14
INFORMATION TO THE P ATIENT RELATING TO T HE NECESSARY PREPARATION FOR 15
ENSURING ACCURATE TEST RESULTS. 16
(B) IF A CLINICAL LABORAT ORY OFFERS PROSTATE –SPECIFIC ANTIGEN 17
TESTING WITHOUT A PR OVIDER ORDER FROM A PATIENT ENCOU NTER, THE 18
LABORATORY IN WHICH BLOOD IS DRAWN FOR THE TEST SHALL PROVIDE WRITTEN 19
INFORMATION TO THE P ATIENT RELATING TO T HE NECESSARY PREPARATION FOR 20
ENSURING ACCURATE TEST RESULTS THAT SHALL ALSO BE MADE: 21
(1) NOT LATER THAN 3 DAYS BEFORE A SCHEDULED APPOINTMENT; 22
AND 23
(2) AVAILABLE THROUGH IN–PERSON EDUCATION. 24
17–803. 25
A CLINICAL LABORATORY ADMINISTERING A PROS TATE–SPECIFIC ANTIGEN 26
TEST SHALL: 27
(1) USE TESTING ASSAYS THAT HAVE BEEN APPROVED B Y THE U.S. 28
FOOD AND DRUG ADMINISTRATION; 29
SENATE BILL 78 3
(2) IMPLEMENT CALIBRATION OF PROSTATE –SPECIFIC ANTIGEN 1
TEST ASSAYS USING WORLD HEALTH ORGANIZATION INTERNATIONAL STANDARDS 2
OR ANOTHER NATIONALLY RECOGNIZED REFERENCE STANDARD; 3
(3) REPORT PROSTATE –SPECIFIC ANTIGEN TEST RESULTS IN 4
NANOGRAMS PER MILLIL ITER AND INCLUDE ANY REFERENCE RANGE UNIQ UE TO 5
THE TESTING ASSAY USED; 6
(4) DOCUMENT AND DISCLOSE TO THE ORDERING PROV IDER THE 7
TEST METHODOLOGY, MANUFACTURER, AND LOT NUMBER OF TH E TESTING ASSAY 8
USED; AND 9
(5) PARTICIPATE IN A CLIN ICAL TESTING PROFICI ENCY PROGRAM 10
RELATING TO PROSTATE –SPECIFIC ANTIGEN TES TS THAT IS RECOGNIZED BY THE 11
CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OR THE COLLEGE OF 12
AMERICAN PATHOLOGISTS. 13
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect July 14
1, 2026. 15