SB 964 — Coverage for Biomarker Testing

Florida Senate - 2024 CS for CS for SB 964 By the Appropriations Committee on HealthBanking and HumanInsurance; Services;

theand CommitteeSenator onCalatayud Banking597-03029-24 and2024964c1 Insurance;A bill to be entitled An act relating to coverage for biomarker testing;

and Senator Calatayud 603-03307-24 2024964c2 A bill to be entitled An act relating to coverage for biomarker testing;

Florida Senate - 2024 CS for CS for SB 964 603-03307-24597-03029-24 2024964c22024964c1 requiring managed care plans to provide Medicaid recipients and health care providers with a clear and convenient process for authorization requests for biomarker testing;

requiring the agency to include the rate impact of the act in certain rates that become effective on a specified date;

The term includes, but is not limited to, single analyte tests, multiplex panel tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing performed at a participating in-network laboratory facility that is certified pursuant to the federal Clinical Laboratory Page 2 of 7 CODING:

Florida Senate - 2024 CS for CS for SB 964 603-03307-24597-03029-24 2024964c22024964c1 whole exome, whole genome, and whole transcriptome sequencing performed at a participating in-network laboratory facility that is certified pursuant to the federal Clinical Laboratory Improvement Amendment (CLIA) or that has obtained a CLIA Certificate of Waiver by the United States Food and Drug Administration for the tests.

As used in this subparagraph, the term “nationally recognized clinical practice guideline” means an evidence-based clinical practice guideline developed by independent organizations or Pagemedical 3professional ofsocieties 7using CODING:a transparent methodology and reporting structure and with a conflict-of-interest policy.

Guidelines developed by such organizations or societies Page 3 of 7 CODING:

Florida Senate - 2024 CS for CS for SB 964 603-03307-24597-03029-24 2024964c22024964c1 medicalestablish professionalstandards societiesof usingcare informed by a transparentsystematic methodologyreview of evidence and reportingan structureassessment of the benefits and withcosts aof conflict-of-interestalternative policy.care options and include recommendations intended to optimize patient care.

Guidelines developed by such organizations or societies establish standards of care informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options and include recommendations intended to optimize patient care.

Nothing in this section shall be construed to prevent or limit the agency from adjusting fees, reimbursement rates, lengths of stay, number of visits, or number of services, or making any other adjustments necessary to Pagecomply 4with the availability of 7moneys CODING:and any limitations or directions provided for in the General Appropriations Act or chapter 216.

If necessary to safeguard the state’s systems of Page 4 of 7 CODING:

Florida Senate - 2024 CS for CS for SB 964 603-03307-24597-03029-24 2024964c22024964c1 complyproviding withservices theto availabilityelderly of moneys and anydisabled limitationspersons orand directionssubject providedto for in the Generalnotice Appropriationsand Actreview orprovisions chapterof 216.s.

If necessary to safeguard the state’s systems of providing services to elderly and disabled persons and subject to the notice and review provisions of s.

Page3. 5 of 7 CODING:

“Clinical utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts Page 5 of 7 CODING:

Florida Senate - 2024 CS for CS for SB 964 603-03307-24597-03029-24 2024964c22024964c1 3.the clinical decision.

“Clinical utility” means the test result provides information that is used in the formulation of a treatment or monitoring strategy that informs a patient’s outcome and impacts the clinical decision.

(c) Recipients and participating providers must be provided access to a clear and convenient process to request authorization for biomarker testing as provided under this Page 6 of 7 CODING:

Florida Senate - 2024 CS for CS for SB 964 603-03307-24597-03029-24 2024964c22024964c1 (c) Recipients and participating providers must be provided access to a clear and convenient process to request authorization for biomarker testing as provided under this subsection.

TheThis Agency for Health Care Administration is directed to include the rate impact of this act inshall thetake applicableeffect MedicaidJuly managed medical assistance program and long- term care managed care program rates that become effective on October 1, 2024.

Section 5.

This act shall take effect October 1, 2024.