PRINTER'SH1754B2133A04587 PWK:JMT 05/29/24 #90 A04587 AMENDMENTS TO HOUSE BILL NO.

21331754 THESponsor: GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL Session of No.

1754REPRESENTATIVE 2023PICKETT INTRODUCEDPrinter's BYNo. MULLINS, CUTLER, STURLA, STENDER, DONAHUE, BURGOS, OCTOBER 16, 2023 BOROWSKI, SANCHEZ AND CERRATO, REFERRED TO COMMITTEE ON INSURANCE, OCTOBER 16, 2023 AN ACT Amending the act of May 17, 1921 (P.L.682, No.284), entitled "An act relating to insurance;

amending,2133 revising,Amend andBill, consolidatingpage the1, lawlines providing18 forthrough the22; incorporation of insurance companies, and the regulation, supervision, and protection of home and foreign insurance companies, Lloyds associations, reciprocal and inter-insurance exchanges, and fire insurance rating bureaus, and the regulation and supervision of insurance carried by such companies, the State Workmen's Insurance Fund;

providingpages penalties;2 through 6, lines 1 through 30;

andpage repealing7, existingline laws,"1; in casualty insurance, providing for coverage for biomarker testing.

Theby Generalstriking Assemblyout all of thesaid Commonwealthlines ofon Pennsylvaniasaid herebypages enactsand asinserting follows:Section 635.9.

SectionCoverage 1.for Biomarker Testing.--(a) An insurer that offers, issues or renews a health insurance policy in this Commonwealth shall include biomarker testing as a covered benefit.

The actfollowing ofshall Mayapply: 17, 1921 (P.L.682, No.284), known as The Insurance Company Law of 1921, is amended by adding a section to read:

Section(1) 635.9.An insurer's coverage for biomarker testing shall be required for the purposes of diagnosis, treatment, appropriate management or ongoing monitoring of a covered person's disease or condition to guide treatment decisions for the covered person.

Coverage for Biomarker Testing.--(a)testing Ancovered insurerunder orthis medicalsubsection assistance or Children's Health Insurance Program managed care plan that amends, delivers or renews a health insurance policy or an agreement with the Department of Human Services on or after January 1, 2024, shall includebe biomarkersubject testingto: as a covered benefit.

(b)(i) BiomarkerArticle testingXXI shall be covered for the purposes of diagnosis,this treatment,act. appropriate management or ongoing monitoring of an insured or enrollee's disease or condition when the test is supported by medical and scientific evidence, including, but not limited to, any of the following:

(1)(ii) labeledApplicable indicationsFederal forlaws anand FDA-approvedregulations. or cleared test;

(2)(iii) indicatedApplicable testslaws forand anregulations FDA-approvedof drug;this Commonwealth.

(3)(iv) warningsThe terms and precautionsconditions onof FDA-approveda drughealth labels;insurance policy, including determinations of medical necessity and clinical review criteria used for utilization review of health care services along with copayment, deductible and coinsurance provisions.

(4)(2) CentersCoverage for Medicarebiomarker andtesting Medicaidshall Servicesbe Nationaladministered Coveragein Determinationsa orsimilar Medicaremanner Administrativeto Contractorother Localhealth Coveragecare Determinations;services provided for under the terms and conditions of a health insurance policy.

or(3) (5)Nothing nationallyin recognizedthis clinicalsubsection practiceshall guidelinesbe andconstrued consensusas statements.requiring an insurer to cover biomarker testing for the purpose of screening beyond the BRCA-related screenings required under section 633.1.

(b.1)(b) TheSubject information obtained through biomarker testing is to beFederal usedapproval, onlyas fornecessary, thea purposesmedical specifiedassistance inor subsectionChildren's (b) and is protected by the Health Insurance PortabilityProgram andmanaged Accountabilitycare Actplan ofshall 1996provide (Publiccoverage Lawof 104-191,biomarker 110testing. Stat.

1936).The following shall apply:

The(1) informationA shallmedical notassistance beor usedChildren's Health Insurance Program managed care plan's coverage for anybiomarker othertesting purposeunder bythis ansubsection insurer.shall be subject to:

(c)(i) BiomarkerArticle testingXXI coveredof underthis subsectionsact. (a) and (b) shall be provided in a manner that limits disruptions in care, including the need for multiple biopsies or biospecimen samples.

(d)(ii) IfApplicable priorFederal authorizationlaws is required for biomarker testing, an insurer or medical assistance or Children's Health Insurance Program managed care plan shall approve or deny a prior authorization request and notifyregulations. the enrollee, the enrollee's health care provider and any entity requesting authorization of the service within 72 hours for nonurgent requests or within 24 hours for urgent requests.

20230HB1754PN21332024/90PWK/HB1754A04587 - 21 - (e)(iii) TheApplicable patientlaws and prescribingregulations practitioner shall have access to clear, readily accessible and convenient processes to request an exception to a coverage policy or an adverse utilization review determination of athis healthCommonwealth. insurer, nonprofit health service plan and health maintenance organization.

(iv) The processterms shalland beconditions madeof readilyan accessibleagreement onwith the healthDepartment insurer's,of nonprofitHuman healthServices, serviceincluding plan'sdeterminations orof medical necessity and clinical review criteria used for utilization review of health maintenancecare organization'sservices publiclyalong accessiblewith Internetcopayment, website.deductible and coinsurance provisions.

(f)(2) AnCoverage insurerfor shallbiomarker submittesting a report to the Insurance Department and a medical assistance or Children's Health Insurance Program managed care plan shall submitbe toadministered the Department of Human Services by January 31 of the following year, the following data from the preceding calendar year in a formsimilar and manner prescribed by the respective department, which the respective department shall publish to theother Presidenthealth procare temporeservices ofprovided theunder Senate, the Speakerterms of the House of Representatives, the members of the Banking and Insuranceconditions Committee of thean Senateagreement andwith the membersDepartment of theHuman InsuranceServices. Committee of the House of Representatives:

(1)(3) TheNothing numberin ofthis exceptionsubsection requestsshall receivedbe byconstrued exception.as requiring a medical assistance or Children's Health Insurance Program managed care plan to cover biomarker testing for the purpose of screening.

(2)(c) The typeterms ofin healththis caresection providersshall orbe given the medicalsame specialtiesdefinitions ofas the healthterms caredefined providerspursuant submittingto exceptionsection requests.2102 unless otherwise noted.

(3)As Theused numberin ofthis exceptionsection, requeststhe byfollowing exceptionwords thatand werephrases deniedshall andhave the reasonsmeanings forgiven to them in this subsection unless the denials.context clearly indicates otherwise:

(4)"Agreement Thewith numberthe Department of exceptionHuman requestsServices." byAn exceptionagreement thatbetween werea approved.medical assistance or Children's Health Insurance Program managed care plan and the Department of Human Services.

(5)"Biomarker." TheA numberdefined characteristic that is measured as an indicator of exceptionnormal requestsbiological byprocesses, exceptionpathogenic thatprocesses wereor initiallyresponses deniedto andan thenexposure appealed.or intervention, including therapeutic interventions.

(6)Molecular, Thehistologic, numberradiologic ofor exceptionphysiologic requestscharacteristics byare exceptiontypes thatof werebiomarkers. 20230HB1754PN2133 - 3 - initially denied and then subsequently reversed by internal appeals or external reviews.

(7)A Thebiomarker medicalis conditions for which patients are granted exceptions due to the likelihood that not receivingan biomarkerassessment testingof willhow likelya resultcovered inperson treatmentor decisionsenrollee thatfeels, couldfunctions cause an adverse reaction or physicalsurvives. harm to the insured.

(g)"Biomarker Astesting." usedThe inanalysis thisof section,a thecovered followingperson wordsor andenrollee's phrasestissue, shallblood haveor theother meaningsbiospecimen givenfor to them in this subsection unless the contextpresence clearlyof indicatesa otherwise:biomarker.

"Biomarker."Biomarker Atesting characteristicincludes, thatbut is objectivelynot measuredlimited andto, evaluatedsingle-analyte astests anand indicatormulti-plex ofpanels normalperformed biologicalat processes, pathogenic processes or pharmacologic responses to a specificparticipating therapeuticin-network intervention,laboratory includingthat knownis gene-drugCLIA interactionscertified forby medicationsthe beingFederal consideredFood forand useDrug orAdministration. already being administered.

The"Medical termassistance" includesor gene"Children's mutations,Health characteristicsInsurance Program managed care plan." A health care plan that uses a gatekeeper to manage the utilization of geneshealth care services, including biomarker testing, by medical assistance or proteinChildren's expression.Health Insurance Program enrollees and integrates the financing and delivery of health care services, including biomarker testing.

"Biomarker"Screening." testing."A Themedical analysisprocedure ofor atest patient'sfor tissue,a bloodcovered person or otherenrollee biospecimenwho has yet to display symptoms of a particular disease or condition for the presencepurpose of adetermining biomarker.their likelihood of having the disease or condition.

The term includes single-analyte tests, multi-plex panel tests, protein expression and whole exome, whole genome and whole transcriptome sequencing.

"Consensus statements." Statements developed by an independent, multidisciplinary panel of experts utilizing a transparent methodology and reporting structure and with a conflict-of-interest policy.

These statements should be aimed at specific clinical circumstances and base the statements on the best available evidence for the purpose of optimizing the outcomes of clinical care.

"Covered benefit." A health care service as specified in the terms of a health insurance policy or an agreement with the 20230HB1754PN2133 - 4 - Department of Human Services.