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*sb0608*
SENATE BILL 608
J5, J4 6lr2956
SB 961/25 – FIN
By: Senator Mautz
Introduced and read first time: February 5, 2026
Assigned to: Finance
Committee Report: Favorable with amendments
Senate action: Adopted
Read second time: March 4, 2026
CHAPTER ______
AN ACT concerning 1
Maryland Medical Assistance Plan and Health Insurance – Pharmacogenomic 2
Testing – Required Coverage 3
FOR the purpose of requiring the Maryland Medical Assistance Program and certain health 4
insurers, nonprofit health services plans, and health maintenance organizations to 5
provide coverage for single–gene and multigene pharmacogenomic testing in certain 6
circumstances; limiting the prior authorization requirements that certain health 7
insurers, nonprofit health services plans, and health maintenance organizations may 8
implement for pharmacogenomic testing; and generally relating to coverage of 9
pharmacogenomic testing. 10
BY adding to 11
Article – Health – General 12
Section 15–102.3(p) and 15–103(a)(2)(xxix) 13
Annotated Code of Maryland 14
(2023 Replacement Volume and 2025 Supplement) 15
BY repealing and reenacting, without amendments, 16
Article – Health – General 17
Section 15–103(a)(1) 18
Annotated Code of Maryland 19
(2023 Replacement Volume and 2025 Supplement) 20
BY repealing and reenacting, with amendments, 21
Article – Health – General 22
2 SENATE BILL 608
Section 15–103(a)(2)(xxvii) and (xxviii) 1
Annotated Code of Maryland 2
(2023 Replacement Volume and 2025 Supplement) 3
BY adding to 4
Article – Insurance 5
Section 15–864 6
Annotated Code of Maryland 7
(2017 Replacement Volume and 2025 Supplement) 8
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 9
That the Laws of Maryland read as follows: 10
Article – Health – General 11
15–102.3. 12
(P) (1) BEGINNING JULY 1, 2027, THE PROVISIONS OF § 15–864(C) AND 13
(D) OF THE INSURANCE ARTICLE APPLY TO MANAGED CARE ORGANIZATIONS IN THE 14
SAME MANNER THEY APPLY TO CARRIERS. 15
(2) A MANAGED CARE ORGANIZATION THAT DOES NOT COMPLY WITH 16
§ 15–864(C) AND (D) OF THE INSURANCE ARTICLE SHALL BE SUBJ ECT TO A 17
MONETARY PENALTY OF UP TO $10,000 PER INSTANCE OF NONCOMPLIANCE AND AN 18
ADDITIONAL PENALTY O F $1,000 PER DAY FOR EACH DAY THE NONCOMPLIANCE 19
CONTINUES AFTER NOTI FICATION OF NONCOMPLIANC E FROM THE DEPARTMENT 20
TO THE MANAGED CARE ORGANIZATION. 21
(3) (I) THE DEPARTMENT MAY REQUIR E A MANAGED CARE 22
ORGANIZATION THAT DO ES NOT COMPLY WITH § 15–864(C) AND (D) OF THE 23
INSURANCE ARTICLE TO SUBMIT AND IMPLEMENT A CORRECTI VE ACTION PLAN 24
WITHIN 30 DAYS AFTER RECEIPT O F A REQUEST FOR A CO RRECTIVE ACTION PLAN 25
FROM THE DEPARTMENT. 26
(II) FAILURE TO IMPLEMENT A CORRECTIVE ACTION PLAN 27
REQUIRED UNDER SUBPA RAGRAPH (I) OF THIS PARAGRAPH MA Y RESULT IN 28
ADDITIONAL ENFORCEMENT ACTIONS. 29
(4) A MANAGED CARE ORGANIZATION SUBJECT TO A PENALTY UNDER 30
THIS SUBSECTION MAY REQUEST AN ADMINISTRATIVE HEARING UNDER TITLE 10, 31
SUBTITLE 2 OF THE STATE GOVERNMENT ARTICLE. 32
(5) (I) THE DEPARTMENT SHALL CONDUCT PERIODIC AUDITS AND 33
REVIEWS OF MANAGED C ARE ORGANIZATIONS TO DETERMINE COMPLIANCE WITH 34
THIS SUBSECTION. 35
SENATE BILL 608 3
(II) THE DEPARTMENT SH ALL ESTABLISH A PROC ESS FOR 1
PATIENTS, PRESCRIBERS, AND LABORATORIES TO REPORT INSTANCES OF 2
NONCOMPLIANCE WITH THIS SUBSECTION. 3
15–103. 4
(a) (1) The Secretary shall administer the Maryland Medical Assistance 5
Program. 6
(2) The Program: 7
(xxvii) Beginning on January 1, 2026, if providing coverage for the 8
delivery of anesthesia, shall provide coverage for the delivery of anesthesia in accordance 9
with § 15–862 of the Insurance Article; [and] 10
(xxviii) Beginning on January 1, 2026, shall provide calcium score 11
testing in accordance with § 15–863 of the Insurance Article; AND 12
(XXIX) BEGINNING ON JULY 1, 2027, SHALL PROVIDE 13
COVERAGE FOR SINGLE –GENE AND MULTIGENE P HARMACOGENOMIC TESTING IN 14
ACCORDANCE WITH § 15–864 OF THE INSURANCE ARTICLE. 15
Article – Insurance 16
15–864. 17
(A) IN THIS SECTION, “PHARMACOGENOMIC TESTING” MEANS LABORATORY 18
GENETIC TESTING , INCLUDING SINGLE –GENE AND MULTIGENE P ANEL TESTING , 19
CONDUCTED TO EVALUAT E HOW AN INDIVIDUAL ’S GENETIC PROFILE MA Y IMPACT 20
THE EFFICACY, SAFETY, OR TOXICITY OF MEDICATIONS. 21
(B) THIS SECTION APPLIES TO: 22
(1) INSURERS AND NONPROF IT HEALTH SERVICE PL ANS THAT 23
PROVIDE HOSPITAL, MEDICAL, OR SURGICAL BENEFITS TO INDIVIDUALS OR GROUPS 24
ON AN EXPENSE –INCURRED BASIS UNDER HEALTH INSURANCE POL ICIES OR 25
CONTRACTS THAT ARE ISSUED OR DELIVERED IN THE STATE; AND 26
(2) HEALTH MAINTENANCE O RGANIZATIONS THAT PR OVIDE 27
HOSPITAL, MEDICAL, OR SURGICAL BENEFITS TO INDIVIDUALS OR GROUPS UNDER 28
CONTRACTS THAT ARE ISSUED OR DELIVERED IN THE STATE. 29
4 SENATE BILL 608
(C) AN ENTITY SUBJECT TO THIS SECTION SHALL PROVIDE COVERAGE FOR 1
SINGLE–GENE AND MULTIGENE PHARMACOGENOMIC TESTING IF: 2
(1) THE PHARMACOGENOMIC TESTING IS ORDERED B Y A TREATING 3
PROVIDER FOR AN INSU RED OR ENROLLEE WITH A DIAGNOSIS OF DEPRE SSION OR 4
ANXIETY; AND 5
(2) (I) THE PHARMACOGENOMIC TESTING IS USED TO GUIDE THE 6
SELECTION, DOSING, OR MANAGEMENT OF A MEDICATION FOR AN INDIVIDUAL; OR 7
(II) THE TREATING PROVIDER IS CONSIDERING A M EDICATION 8
CHANGE, DOSE ADJUSTMENT , OR AUGMENTATION AND THE MEDICATION UNDER 9
CONSIDERATION HAS A KNOWN GENE–DRUG INTERACTION; 10
(3) THE INDIVIDUAL IS BE ING TREATED , OR IS EXPECTED TO BE 11
TREATED, WITH A MEDICATION FOR WHICH EVIDENCE–BASED PHARMACOGENOMIC 12
INFORMATION IS AVAILABLE DEMONSTRATING A CLINICALLY MEANINGFUL IMPACT 13
ON DRUG EFFICACY, SAFETY, OR RISK OF ADVERSE EVENTS; 14
(4) THE PHARMACOGENOMIC TESTING IS CONSISTEN T WITH 15
GENERALLY ACCEPTED STANDARDS OF MEDICAL PRACTICE, INCLUDING CLINICAL 16
GUIDELINES, PEER–REVIEWED MEDICAL LIT ERATURE, OR DRUG LABELING 17
APPROVED BY THE FEDERAL FOOD AND DRUG ADMINISTRATION; 18
(5) THE RESULTS O F THE PHARMACOGENOMI C TESTING ARE 19
INTENDED TO BE USED IN CLINICAL DECISION MAKING TO OPTIMIZE THERAPEUTIC 20
OUTCOMES, REDUCE THE LIKELIHOO D OF ADVERSE DRUG RE ACTIONS, OR AVOID 21
INEFFECTIVE THERAPY; AND 22
(6) THE PHARMACOGENOMIC TESTING IS COVERED BY THE FEDERAL 23
MEDICARE PROGRAM UNDE R A NATIONAL OR LOCA L COVERAGE DETERMINA TION 24
ISSUED BY A MEDICARE ADMINISTRATIVE CONTRACTOR. 25
(D) A PRIOR AUTHORIZATION REQUIREMENT IMPOSED FOR COVERAGE 26
REQUIRED UNDER THIS SECTION: 27
(1) SHALL PROVIDE A CLEA R AND MEANINGFUL PATHWAY FOR 28
COVERAGE THAT ENSURE S TIMELY ACCESS TO T HE COVERAGE REQUIRED UNDER 29
SUBSECTION (C) OF THIS SECTION; 30
(2) SHALL REQUIRE ONLY T HE MINIMUM NECESSARY 31
DOCUMENTATION FROM T HE TREATING PROVIDER TO DETERMINE WHETHER THE 32
PATIENT MEETS THE CR ITERIA FOR COVERAGE UNDER SUBSECTION (C) OF THIS 33
SECTION; 34
SENATE BILL 608 5
(3) SHALL ALLOW A SUFFIC IENT AUTHORIZATION T IME FRAME 1
FOLLOWING THE COLLECTION OF A SPEC IMEN FOR PHARMACOGEN OMIC TESTING 2
FOR THE SUBMISSION OF A PRIOR AUTHORIZATION REQUEST AND CLAIMS RELATED 3
TO PHARMACOGENOMIC TESTING; 4
(4) SHALL ALLOW A PRIOR AUTHORIZATION REQUES T TO BE 5
SUBMITTED BY A TREATING PROVIDER OR A LABORATORY PROVIDER; AND 6
(5) MAY NOT IMPOSE UNDUE ADMINISTRATIVE BURDENS OR DELAYS 7
THAT CREATE BARRIERS TO CARE FOR AN INSURED OR ENROLLEE. 8
(E) (1) AN ENTITY THAT DOES N OT COMPLY WITH THIS SECTION SHALL 9
BE SUBJECT TO A MONE TARY PENALTY OF UP T O $10,000 PER INS TANCE OF 10
NONCOMPLIANCE AND AN ADDITIONAL PENALTY OF $1,000 PER DAY FOR EACH DAY 11
THE NONCOMPLIANCE CO NTINUES AFTER NOTIFI CATION OF NONCOMPLIA NCE 12
FROM THE COMMISSIONER TO THE ENTITY. 13
(2) (I) THE COMMISSIONER MAY REQUIRE AN ENTITY THAT D OES 14
NOT COMPLY WITH THIS SECTION TO SUBM IT AND IMPLEMENT A C ORRECTIVE 15
ACTION PLAN WITHIN 30 DAYS AFTER RECEIPT O F A REQUEST FOR A CO RRECTIVE 16
ACTION PLAN FROM THE COMMISSIONER. 17
(II) FAILURE TO IMPLEMENT A CORRECTIVE ACTION PLAN 18
REQUIRED UNDER SUBPA RAGRAPH (I) OF THIS PAR AGRAPH MAY RESULT IN 19
ADDITIONAL ENFORCEMENT ACTIONS. 20
(3) AN ENTITY SUBJECT TO A PENALTY UNDER THIS SUBSECTION MAY 21
REQUEST AN ADMINISTR ATIVE HEARING UNDER TITLE 10, SUBTITLE 2 OF THE 22
STATE GOVERNMENT ARTICLE. 23
(F) (1) THE COMMISSIONER SHALL CO NDUCT PE RIODIC AUDITS AND 24
REVIEWS OF ENTITIES SUBJECT TO THIS SECT ION TO DETERMINE COM PLIANCE 25
WITH THIS SECTION. 26
(2) THE COMMISSIONER SHALL ES TABLISH A PROCESS FO R 27
PATIENTS, PRESCRIBERS, AND LABORATORIES TO REPORT INSTANCES OF 28
NONCOMPLIANCE WITH THIS SECTION. 29
(D) THE FAILURE OF A CARR IER TO PROVIDE COVER AGE FOR A 30
PHARMACOGENOMIC TEST REQUIRED TO BE COVER ED UNDER THIS SECTIO N 31
CONSTITUTES AN ADVERSE DECISION. 32
6 SENATE BILL 608
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall apply to all 1
policies, contracts, and health benefit plans issued, delivered, or renewed in the State on or 2
after January 1, 2027. 3
SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 4
October 1, 2026 January 1, 2027. 5
Approved:
________________________________________________________________________________
Governor.
________________________________________________________________________________
President of the Senate.
________________________________________________________________________________
Speaker of the House of Delegates.