SB 307 — AN ACT CONCERNING MEDICAID COVERAGE OF BIOMARKER TESTING.

Substitute Senate GeneralBill Assembly File No.

317307 FebruaryPublic Session,Act 2024 Substitute Senate Bill No.

30724-50 Senate,AN AprilACT 8,CONCERNING 2024MEDICAID TheCOVERAGE CommitteeOF onBIOMARKER HumanTESTING. Services reported through SEN.

LESSER of the 9th Dist., Chairperson of the Committee on the part of the Senate, that the substitute bill ought to pass.

AN ACT CONCERNING MEDICAID COVERAGE OF BIOMARKER TESTING.

(3) "Consensus"Clinical statements"utility" means statementsthe developedtest byresult anprovides independent,information multidisciplinarythat panelis used in the formulation of expertsa utilizingtreatment or monitoring strategy that informs a transparentpatient's sSB307outcome /and Fileimpacts No.the clinical decision.

317The 1most sSB307appropriate Filetest No.may include both information that is actionable and some information that cannot be immediately used in the formulation of a clinical decision.

317Substitute methodologySenate andBill reportingNo. structure and with a conflict-of-interest policy that are (A)aimedat specificclinicalcircumstances,and(B)based on the best available evidence for the purpose of optimizing clinical care outcomes.

307 (4) "Nationally"Consensus recognizedstatements" clinical practice guidelines" means evidence-basedstatements guidelines developed by independentan organizationsindependent, ormultidisciplinary medicalpanel professionalof societiesexperts utilizing a transparent methodologiesmethodology and reporting structuresstructure and with a conflict-of-interest policiespolicy that (A)are establish(A)aimedat standardsspecificclinicalcircumstances,and(B)based ofon carethe informedbest byavailable a systematic review of evidence andfor assessments of the benefitspurpose and costs of alternativeoptimizing clinical care options,outcomes. and (B) include recommendations intended to optimize patient care.

(5) "Nationally recognized clinical practice guidelines" means evidence-based guidelines developed by independent organizations or medical professional societies utilizing transparent methodologies and reporting structures and conflict-of-interest policies that (A) establish standards of care informed by a systematic review of evidence and assessments of the benefits and costs of alternative care options, and (B) include recommendations intended to optimize patient care.

The commissioner shall conditionensure that such coverage onis medicalmedically andnecessary scientificpursuant evidenceto supportingsection such17b-259b testing, including, but not limited to, (1) (A) approval of such testing by the federalgeneral Foodstatutes andand, Drugto Administration,assist orin (B)such recommendationsdetermination provided on the labels of certainmedical drugsnecessity, approvedshall byanalyze therelevant federalinformation Food and Druguse Administrationapplicable thatclinical suchguidelines testing should be conducted prior to thehelp useinform of such drugs,determination, (2)including nationalmedical coverageand determinationsscientific orevidence localsupporting coveragesuch determinationstest forwhen Medicare Administrative Contractors by the Centerstest forprovides Medicareclinical andutility Medicaidas Services,demonstrated (3)by nationallymedical recognized clinical practice guidelines and consensusscientific statements,evidence, orincluding, (4)but anynot otherlimited sourcesto, forone establishingor medicalmore necessity in accordance with section 17b-259b of the generalfollowing: statutes.

(c)(1) NothingApproval inof thissuch sectiontest shallby bethe construedfederal toFood limitand theDrug abilityAdministration or recommendations on labels of drugs approved by the Departmentfederal ofFood Socialand ServicesDrug Administration to requireconduct priorsuch authorizationtest, to(2) ensurenational thatcoverage adeterminations requestor local coverage determinations for biomarkerMedicare testingAdministrative meetsContractors by the standardsCenters underfor thisMedicare section.and Medicaid Services, or (3) nationally recognized clinical practice guidelines and consensus statements.

ThisNothing actin shallthis takesection effect as follows and shall amendPublic theAct followingNo. sections:

sSB30724-50 /2 Fileof 3 Substitute Senate Bill No.

317307 2change sSB307the Filerequirement No.in section 17b-259b of the general statutes that policies, guidelines and similar information shall be used solely as guidelines and shall not be the basis for a final determination of medical necessity.

317(c)Nothing Sectionhereinshallrestrict 1theability JulyoftheDepartment 1,ofSocial 2024Servicestorequireprior Newauthorizationtoassure sectionthatarequest Statementfortesting ofmeets Legislativethe Commissioners:standards under this section.

In(d) Subsec.Any Medicaid enrollee who is adversely affected by a decision of the department under this section may request a hearing in accordance with section 17b-60 of the general statutes.

(b),(e) "test"The wasCommissioner changedof Social Services shall ensure that the coverage as defined in subsection (b) of this section is provided in a manner that is designed to "testing"limit fordisruptions consistency,in Subsec.care.

(b)(1)Approved wasMay redrafted28, for2024 clarity,Public andAct inNo. Subsec.

(c),24-50 "testing"3 wasof changed3 to "biomarker testing" for consistency.

HS Joint Favorable Subst.

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317 3 sSB307 File No.

317 The following Fiscal Impact Statement and Bill Analysis are prepared for the benefit of the members of the General Assembly, solely for purposes of information, summarization and explanation and do not represent the intent of the General Assembly or either chamber thereof for any purpose.

In general, fiscal impacts are based upon a variety of informational sources, including the analyst’s professional knowledge.

Whenever applicable, agency data is consulted as part of the analysis, however final products do not necessarily reflect an assessment from any specific department.

OFA Fiscal Note State Impact:

See Below Municipal Impact:

None Explanation The bill requires Medicaid coverage of biomarker testing and conditions such as coverage on certain medical and scientific evidence.

As such testing is currently covered, and the bill maintains prior authorization and medical necessity as a potential condition, the bill is not anticipated to result in a fiscal impact to the Department of Social Services (DSS).

However, to the extent DSS conditions coverage on a more expansive basis, beyond the current definition of medical necessity, the state would incur increased Medicaid costs.

The Out Years The annualized ongoing fiscal impact identified above would continue into the future subject to the conditions on which biomarking testing is covered.

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317 4 sSB307 File No.

317 OLR Bill Analysis sSB 307 AN ACT CONCERNING MEDICAID COVERAGE OF BIOMARKER TESTING.

SUMMARY This bill requires the Department of Social Services (DSS), to the extent federal law allows, to provide coverage for biomarker testing to diagnose, treat, manage, or monitor a Medicaid enrollee’s disease or condition.

The bill requires DSS to condition coverage on medical and scientific evidence supporting the test, including the following:

1.

FDA approval or FDA-approved drug label recommendations;

2.