HB 1335 — Biomarker Testing

A Cover Florida plan entity makes all benefit plan and marketing materials available in English and Spanish.

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hb1335-00hb1335-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HBCS/HB 1335 2025 5.include an assessment of how a patient feels, functions, or survives.

In2. order to provide for consumer choice, Cover Florida plan entities develop two alternative benefit option plans having different cost and benefit levels, including at least one plan that provides catastrophic coverage.

6."Biomarker testing" means an analysis of a patient's tissue, blood, or other biospecimen for the presence of a biomarker.

PlansThe withoutterm catastrophicincludes, coveragebut provideis coveragenot optionslimited forto, servicessingle including,analyte buttests, notmultiplex limitedpanel to:tests, protein expression, and whole exome, whole genome, and whole transcriptome sequencing that are:

PreventiveBilled healthunder services,either includingCurrent immunizations,Procedural annualTerminology health assessments, well-woman and well-care services, and preventive screenings such as mammograms, cervical cancer screenings, and noninvasive colorectal or prostateProprietary screenings,Laboratory andAnalyses colorectalcodes; cancer screenings in accordance with s.

627.64192,and s.b.

627.6614,Performed at a participating in-network laboratory facility that is certified pursuant to the federal Clinical Laboratory Improvement Amendment (CLIA) or s.that has obtained a CLIA Certificate of Waiver by the United States Food and Drug Administration for the tests.

641.31093.3.

b."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.

Incentives(c) A recipient and participating provider shall have access to a clear and convenient process to request authorization for routinebiomarker preventivetesting care.as provided under this subsection.

c.Such process shall be made readily accessible to all recipients and participating providers online.

OfficeBy visitsAugust for1, 2025, the diagnosisagency andshall treatmentestablish ofa illnessprovider orreimbursement injury.Page 3 of 6 CODING:

d.

Office surgery, including anesthesia.

e.

Behavioral health services.

f.

Durable medical equipment and prosthetics.

g.

Diabetic supplies.

7.

Plans providing catastrophic coverage, at a minimum, provide coverage options for all of the services listed under subparagraph 6.;

however, such plans may include, but are not limited to, coverage options for:

a.

Inpatient hospital stays.

b.

Hospital emergency care services.

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hb1335-00hb1335-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HBCS/HB 1335 2025 c.schedule and billing codes for the Proprietary Laboratory Analyses codes to cover biomarker testing as provided in this subsection.

Urgent(d) careThis services.subsection does not require coverage of biomarker testing for screening purposes.

d.The agency may pay for medically necessary blood-based biomarker tests for colorectal cancer screening.

Outpatient facility services, outpatient surgery, and outpatient diagnostic services.

8.

All plans offer prescription drug benefit coverage, use a prescription drug manager, or offer a discount drug card.

9.

Plan enrollment materials provide information in plain language on policy benefit coverage, benefit limits, cost- sharing requirements, and exclusions and a clear representation of what is not covered in the plan.

Such enrollment materials must include a standard disclosure form adopted by rule by the Financial Services Commission, to be reviewed and executed by all consumers purchasing Cover Florida plan coverage.

10.

Plans offered through a qualified employer meet the requirements of s.

125 of the Internal Revenue Code.

Section 627.64192,409.9745, Florida Statutes, is createdamended to read:

627.64192409.9745 CoverageManaged forcare colorectalplan cancerbiomarker screeningtesting.— and diagnosis.— (1) AsA usedmanaged incare thisplan section,must theprovide termcoverage "costfor sharing"biomarker includestesting copayments,for coinsurance,recipients, dollaras limits,authorized andunder deductibless. imposed on the covered person.

The409.906, termat doesthe notsame includescope, premiums.duration, and frequency as the Medicaid program provides for other medically necessary treatments.

(2)(a)(a)(2) A healthrecipient insuranceand policyhealth issued,care amended,provider delivered,shall orhave renewedaccess onto ora afterclear Januaryand 1,convenient 2026,process mustto providerequest coverageauthorization for abiomarker colorectaltesting canceras screeningprovided test,under procedure,this orsection. Page 4 of 8 CODING:

Such process shall be made readily accessible on the website of the managed care plan.

(b)(3) This section does not require coverage of biomarker testing for screening purposes.

(c)(4) The agency shall include the rate impact of this section in the applicable Medicaid managed medical assistance program and long-term care managed care program rates.

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hb1335-00hb1335-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HBCS/HB 1335 2025 examination(2) conductedA bymanaged acare healthplan caremust providerprovide whichcoverage is:for medically necessary blood-based biomarker tests for colorectal cancer screening at the same scope and frequency as the Medicaid program provides for other medically necessary tests or screenings for colorectal cancer.

1.a.

Approved by the United States Food and Drug Administration and meets the requirements of the National Coverage Determination 210.3 made by the Centers for Medicare and Medicaid Services;

or b.

In accordance with the most recent or most recently published guidelines and recommendations established by the American Cancer Society for the ages, family histories, and frequencies referenced in such guidelines and recommendations;

and 2.

Deemed appropriate by the attending physician after conferring with the patient.

(b) The health insurer may not impose any cost sharing on the insured for the coverage of a colorectal cancer screening test, procedure, or examination described in paragraph (a), regardless of whether the test, procedure, or examination is conducted by an in-network or out-of-network health care provider.

(3) This section does not apply to a nonrenewable health insurance policy written for a period of less than 6 months.

SectionThe 627.6614,Agency Floridafor Statutes,Health isCare createdAdministration tomust read:contract for an independent, actuarially sound 5-year comparative cost-benefit analysis of the cost-effectiveness of providing coverage of blood-based biomarker tests for colorectal cancer in the Medicaid program.

627.6614The Coverageanalysis formust colorectaladdress, cancerat screeninga andminimum, diagnosis.— (1) As used in this section, the termfollowing "costfactors: sharing" Page 5 of 8 CODING:

(1) Data on the utilization of blood-based biomarker tests for colorectal cancer screening and other tests or screenings for colorectal cancer, including fecal immunochemical tests, fecal occult blood tests, stool DNA tests, and colonoscopies, and the total costs of such tests or screenings, broken out by type.

(2) Numeric and demographic data on recipients who received inpatient or outpatient treatment for colorectal cancer, total costs of such treatment, and total costs of other medically necessary care provided which was related to the colorectal cancer diagnosis.

(3) Data on cost avoidance, if any, attributable to the use of blood-based biomarker tests for colorectal cancer, including, but not limited to, cost avoidance due to Page 5 of 6 CODING:

hb1335-00hb1335-01-c1 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HBCS/HB 1335 2025 includessubstitution copayments,for coinsurance,more dollarcostly limits,tests and deductiblesdue imposedto onreductions thein coveredtreatment person.cost attributable to earlier diagnosis.

The(4) termData doeson notdeaths includeof premiums.Medicaid recipients attributable to colorectal cancer or a complication from colorectal cancer over the term of the study.

(2)(a)The Aagency healthmust insurancesubmit policyan issued,interim amended,report delivered,by orNovember renewed30, on2028, orand aftera Januaryfinal 1,report 2026,by mustNovember provide30, coverage2030, forrespectively, ato colorectalthe cancerGovernor, screeningthe test,President procedure,of orthe examinationSenate, conductedand bythe aSpeaker healthof carethe providerHouse whichof is:Representatives.

1.a.

Approved by the United States Food and Drug Administration and meets the requirements of the National Coverage Determination 210.3 made by the Centers for Medicare and Medicaid Services;

or b.

In accordance with the most recent or most recently published guidelines and recommendations established by the American Cancer Society for the ages, family histories, and frequencies referenced in such guidelines and recommendations;

and 2.

Deemed appropriate by the attending physician after conferring with the patient.

(b) The health insurer may not impose any cost sharing on the insured for the coverage of a colorectal cancer screening test, procedure, or examination described in paragraph (a), regardless of whether the test, procedure, or examination is conducted by an in-network or out-of-network health care provider.

SectionThe 641.31093,provisions Floridaof Statutes,this isact createdamending Pages. 6 of 8 CODING:

Words409.906(29)(d), strickenFlorida areStatutes, deletions;and s.

words409.9745, underlinedFlorida areStatutes, additions.shall stand repealed on July 1, 2031, unless saved from repeal through reenactment by the Legislature.

hb1335-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 1335 2025 to read:

641.31093 Coverage for colorectal cancer screening and diagnosis.— (1) As used in this section, the term "cost sharing" includes copayments, coinsurance, dollar limits, and deductibles imposed on the covered person.

The term does not include premiums.

(2)(a) A health maintenance contract issued, amended, delivered, or renewed on or after January 1, 2026, must provide coverage for a colorectal cancer screening test, procedure, or examination conducted by a health care provider which is:

1.a.

Approved by the United States Food and Drug Administration and meets the requirements of the National Coverage Determination 210.3 made by the Centers for Medicare and Medicaid Services;

or b.

In accordance with the most recent or most recently published guidelines and recommendations established by the American Cancer Society for the ages, family histories, and frequencies referenced in such guidelines and recommendations;

and 2.

Deemed appropriate by the attending physician after conferring with the patient.

(b) The health maintenance organization may not impose any cost sharing on the subscriber for the coverage of a colorectal cancer screening test, procedure, or examination described in Page 7 of 8 CODING:

Words stricken are deletions;

words underlined are additions.

hb1335-00 F L O R I D A H O U S E O F R E P R E S E N T A T I V E S HB 1335 2025 paragraph (a), regardless of whether the test, procedure, or examination is conducted by an in-network or out-of-network health care provider.

(3) This section does not apply to a nonrenewable individual health maintenance contract written for a period of less than 6 months.

This act shall take effect Julyupon 1,becoming 2025.a law.

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