The Florida Senate
BILL ANALYSIS AND FISCAL IMPACT STATEMENT
(This document is based on the provisions contained in the legislation as of the latest date listed below.)
Prepared By: The Professional Staff of the Appropriations Committee on Health and Human Services
BILL: CS/SB 964
INTRODUCER: Banking and Insurance Committee and Senator Calatayud
SUBJECT: Coverage for Biomarker Testing
DATE: February 12, 2024
ANALYST STAFF DIRECTOR REFERENCE ACTION
1. Johnson Knudson BI Fav/CS
2. Barr McKnight AHS Pre-meeting
3. FP
Please see Section IX. for Additional Information:
COMMITTEE SUBSTITUTE - Substantial Changes
I. Summary:
CS/SB 964 requires the Florida Medicaid program and the Division of State Group Insurance
program to provide coverage for biomarker testing for the diagnosis, treatment, management,
and ongoing monitoring of disease or condition of an enrollee or insured, respectively to guide
treatment decisions when such testing provides clinical utility as demonstrated by medical and
scientific evidence.
The bill has a significant, negative fiscal impact on both the Florida Medicaid program and the
Division of State Group Insurance. However, the impact is indeterminate at this time. See
Section V., Fiscal Impact Statement.
The bill has an effective date of July 1, 2024.
II. Present Situation:
Biomarkers
1
and Tumor Markers
2
A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of
a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how
well the body responds to a treatment for a disease or condition.
1
Biomarker Testing for Cancer Treatment - NCI (last visited Jan. 25, 2024).
2
Tumor Markers - NCI (cancer.gov) (last visited Jan. 28, 2024).
REVISED: BILL: CS/SB 964 Page 2
A tumor marker is anything present in or produced by cancer cells or other cells of the body in
response to cancer or certain benign (noncancerous) conditions. Tumor markers have
traditionally been proteins or other substances that are made at higher amounts by cancer cells
than normal cells. These can be found in the blood, urine, tumors, or other tissues or bodily
fluids of some patients with cancer. Increasingly, however, genomic markers (such as tumor
gene mutations, patterns of tumor gene expression, and nongenetic changes in tumor DNA) are
being used as tumor markers. These markers are found both in tumors themselves and in tumor
fragments shed into bodily fluids. Many different tumor markers have been characterized and are
in clinical use.
3
Some are associated with only one type of cancer, whereas others are associated
with multiple cancer types.
Biomarker testing is a method to look for genes, proteins, and other substances (biomarkers or
tumor markers) that can provide information about cancer and other conditions.
Application of Tumor Markers in Cancer Care
4
Tumor markers that indicate whether someone is a candidate for a particular targeted therapy
5
are sometimes referred to as biomarkers for cancer treatment. Tumor markers can provide a wide
variety of information that is important for cancer care, such as:
Helping to diagnose cancer.
The type of cancer.
The stage of the cancer.
An estimate of prognosis.
Determination of what treatment may be effective. How well the treatment is working.
Whether cancer has returned.
Types of Tumor Marker Tests
A number of tumor marker tests are currently being used for a wide range of cancer types.
6
Many
tumor marker tests are conducted by commercial and academic laboratories. Sometimes cancer
centers use a tumor marker test developed within a single clinical laboratory to meet a specific
medical need. All tumor markers are tested in laboratories that meet standards set by the Clinical
Laboratory Improvement Amendments program.
7
Division of State Group Insurance
Under the authority of s. 110.123, F.S., the Department of Management Services (DMS), through
the Division of State Group Insurance, administers the state group health insurance program
under a cafeteria plan consistent with s. 125, Internal Revenue Code. To administer the state
group health insurance program, the DMS contracts with third party administrators for self-
insured health plans and insured (HMOs), as well as a pharmacy benefits manager for the state
employees’ self-insured prescription drug program pursuant to s. 110.12315, F.S.
3
Tumor Marker Tests in Common Use - NCI (cancer.gov) (last visited Jan. 24, 2024).
4
Tumor Markers - NCI (cancer.gov) (last visited Jan. 28, 2024).
5
This is a type of treatment that uses drugs or other substances to target specific molecules that cancer cells need to survive
and spread. See Definition of targeted therapy - NCI Dictionary of Cancer Terms - NCI (last visited Jan. 27, 2024).
6
Tumor Marker Tests in Common Use - NCI (cancer.gov) (last visited Jan. 23, 2024).
7
Clinical Laboratory Improvement Amendments (CLIA) | CDC (last visited Jan. 23, 2024). BILL: CS/SB 964 Page 3
Florida’s Medicaid Program
8
Administration of the Program
The Agency for Health Care Administration (AHCA) is the single state agency responsible for
the administration of the Florida Medicaid program, authorized under Title XIX of the Social
Security Act (SSA). This authority includes establishing and maintaining a Medicaid state plan
approved by the federal Centers for Medicare and Medicaid Services (CMS) and maintaining
any Medicaid waivers needed to operate the Florida Medicaid program as directed by the Florida
Legislature.
A Medicaid state plan is an agreement between a state and the federal government describing
how that state administers its Medicaid programs; it establishes groups of individuals covered
under the Medicaid program, services that are provided, payment methodologies, and other
administrative and organizational requirements. State Medicaid programs may request a formal
waiver of the requirements codified in the SSA. Federal waivers give states flexibility not
afforded through their Medicaid state plan.
In Florida, most Medicaid recipients receive their services through a managed care plan
contracted with the AHCA under the Statewide Medicaid Managed Care (SMMC) program. The
SMMC program has three components: Managed Medical Assistance (MMA), Long-Term Care
(LTC), and Dental. Florida’s SMMC program benefits are authorized through federal waivers
and are specifically required by the Florida Legislature in ss. 409.973 and 409.98, F.S.
Mandatory Medicaid Coverage
Section 409.905, F.S., relating to mandatory Medicaid services, provides that the AHCA may
make payments for delineated services, which are required of the state by Title XIX of the Social
Security Act. Currently, the Florida Medicaid program covers biomarker testing under s.
409.905(7), F.S., as a mandatory service under the category of “Independent Laboratory
Services.” Florida Medicaid reimburses eligible providers for biomarker testing services in
accordance with Rule 59G-4.190, F.A.C., the Laboratory Services and Coverage Policy, and
Rule 59G-4.002, F.A.C., the Independent and Practitioner Laboratory Fee Schedules.
An eligible recipient must be enrolled in the Florida Medicaid program on the date of service,
and the services provided must be determined medically necessary, not duplicative of another
service, and meet the criteria of the policy. When determining coverage or if it is appropriate to
add a code to a Medicaid fee schedule, the AHCA considers clinical and practice guidelines as
well as costs and maintaining budget neutrality.
The SMMC plans have the flexibility to cover services above and beyond the AHCA’s coverage
policies, but they may not be more restrictive.
8
Agency for Health Care Administration, 2024 Legislative Bill Analysis, House Bill 885 (Jan. 19, 2024)(on file with the
Senate Appropriations Committee on Health and Human Services) BILL: CS/SB 964 Page 4
Medically Necessary or Medical Necessity.
9
Under Florida’s Medicaid program, for a medical or
allied care, goods, or services furnished or ordered to be considered medically necessary or a
medical necessity, it must meet the following conditions:
Be necessary to protect life, to prevent significant illness or significant disability, or to
alleviate severe pain.
Be individualized, specific, and consistent with symptoms or confirmed diagnosis of the
illness or injury under treatment, and not in excess of the patient’s needs.
Be consistent with generally accepted professional medical standards as determined by the
Medicaid program, and not experimental or investigational.
Be reflective of the level of service that can be safely furnished, and for which no equally
effective and more conservative or less costly treatment is available statewide.
Be furnished in a manner not primarily intended for the convenience of the recipient, the
recipient's caretaker, or the provider.
The fact that a provider has prescribed, recommended, or approved medical or allied care,
goods, or services does not, in itself, make such care, goods or services medically necessary
or a medical necessity or a covered service.
Medically necessary or medical necessity for inpatient hospital services requires that those
services furnished in a hospital on an inpatient basis could not, consistent with the provisions
of appropriate medical care, be effectively furnished more economically on an outpatient
basis or in an inpatient facility of a different type.
Federal and State Insurance Coverage for Biomarker Testing
In 2020 and 2022, the federal CMS issued a national coverage determination
10
and local
coverage determination
11
that increased access to comprehensive biomarker testing and next-
generation sequencing for Medicare beneficiaries.
Since 2021, four states have enacted laws mandating coverage of testing, diagnosis, treatment,
management, or monitoring of a medical condition, including the following states
12
:
Louisiana Senate Bill 84 requires broad health insurance coverage for genetic and molecular
testing for cancer only.
13
Illinois House Bill 1779 requires state-regulated insurance and managed care plans to cover
biomarker testing for the purposes of diagnosis, treatment, management, or monitoring of
any medical condition.
14
Arizona House Bill 2144 requires health insurance coverage for biomarker testing for the
purposes of diagnosis, treatment, management, or monitoring of any medical condition.
15
9
Agency for Health Care Administration, Florida Medicaid, Definitions Policy (Aug. 2017) Definitions of commonly used
terms that are applicable to all sections of Rule 59G, F.A.C., unless otherwise specified.
10
NCD - Next Generation Sequencing (NGS) (90.2) (cms.gov) (last visited Jan. 20, 2024).
11
LCD - Genomic Sequence Analysis Panels in the Treatment of Solid Organ Neoplasms (L37810) (cms.gov) (last visited
Jan 20, 2024).
12
State Legislation Requiring Coverage of Biomarker Testing Gains Momentum (accc-cancer.org) (Sep. 30, 2022) (last
visited Jan. 24, 2024).
13
LA SB84 | 2021 | Regular Session | LegiScan (last visited Jan. 24, 2024).
14
IL HB1779 | 2021-2022 | 102nd General Assembly | LegiScan (last visited Jan. 24, 2024).
15
AZ HB2144 | 2022 | Fifty-fifth Legislature 2nd Regular | LegiScan (last visited Jan. 24, 2024). BILL: CS/SB 964 Page 5
Rhode Island Senate Bill 2201 requires state-regulated individual and group health insurance
plans to cover biomarker testing for the purposes of diagnosis, treatment, management, or
monitoring of any medical condition.
16
Recent Studies on the Long-Term Cost Impacts of Biomarker Testing
A 2022 study found the addition of biomarker testing (liquid biopsy) for non-small cell lung
cancer resulted in incremental cost savings of $3,065 per patient compared to tissue biopsy
alone. Increased detection of actionable alterations, using liquid biopsy, was also associated with
more patients being treated with targeted therapy. Major drivers of cost-effectiveness were drug
acquisition costs and prevalence of actionable alterations.
17
A 2018 study found that biomarker testing for non-small cell lung cancer, instead of single-gene
testing, decreased expected testing procedure related costs to the health plan payer by $24,651.
First-line and maintenance treatment costs increased by $842,205, offset by a $385,000 decrease
in second-line treatment and palliative care costs. Over 5 years, total budget impact was
$432,554 ($0.0072 per member per month).
18
III. Effect of Proposed Changes:
The bill creates the following definitions for Sections 1 and 2 of the bill relating to the State
Group Insurance Program and the Medicaid program, respectively:
“Biomarker” means a defined characteristic that is measured as an indicator of normal
biological processes, pathogenic processes, or responses to an exposure or intervention,
including therapeutic interventions. “Biomarker testing” means an analysis of a patient’s
tissue, blood, or other biospecimen for the presence of a biomarker.
“Clinical utility” means that the test result provides information used in the formulation of a
treatment or in a monitoring strategy that impacts a patient’s outcome and informs the
clinical decision.
“Nationally recognized clinical practice guidelines” means evidence-based clinical practice
guidelines developed by independent organizations or medical professional societies using a
transparent methodology and reporting structure and with a conflict-of-interest policy.
Section 1 amends s. 110.12303, F.S., relating to the State Group Insurance program (program) to
mandate coverage of biomarker testing for policies issued on or after January 1, 2025. This
coverage would include the diagnosis, treatment, management, or ongoing monitoring of an
insured’s disease or condition to guide treatment decisions when such testing provides clinical
16
RI S2201 | 2022 | Regular Session | LegiScan (last visited Jan. 24, 2024).
17
Ezeife DA, Spackman E, Juergens RA, Laskin JJ, Agulnik JS, Hao D, Laurie SA, Law JH, Le LW, Kiedrowski LA,
Melosky B, Shepherd FA, Cohen V, Wheatley-Price P, Vandermeer R, Li JJ, Fernandes R, Shokoohi A, Lanman RB, Leighl
NB. The economic value of liquid biopsy for genomic profiling in advanced non-small cell lung cancer. Ther Adv Med
Oncol. 2022 Jul 26;14:17588359221112696. doi: 10.1177/17588359221112696. PMID: 35923926; PMCID: PMC9340413.
The economic value of liquid biopsy for genomic profiling in advanced non-small cell lung cancer - PubMed (nih.gov) (last
visited Jan. 27, 2024).
18
Yu TM, Morrison C, Gold EJ, Tradonsky A, Arnold RJG. Budget Impact of Next-Generation Sequencing for Molecular
Assessment of Advanced Non-Small Cell Lung Cancer. Value Health. 2018 Nov;21(11):1278-1285. doi:
10.1016/j.jval.2018.04.1372. Epub 2018 Jun 8. PMID: 30442274. https://pubmed.ncbi.nlm.nih.gov/30442274/ (last visited
Jan. 28, 2024). BILL: CS/SB 964 Page 6
utility to the insured as demonstrated by medical and scientific evidence, including but not
limited to, any of the following:
Labeled indications for a test approved or cleared by the United States Food and Drug
Administration (FDA) or indicated tests for an FDA-approved drug.
Federal Centers for Medicare and Medicaid Services (CMS) national coverage
determinations or Medicare Administrative Contractor local coverage determinations.
Nationally recognized clinical practice guidelines.
The program is required to outline a process for insureds and providers to access a process to
request an authorization for biomarker testing.
The biomarker testing services may not be construed to require coverage of biomarker testing for
screening purposes.
Section 2 amends s. 409.906, F.S., relating to optional Medicaid services to authorize the
Agency for Health Care Administration (AHCA) to pay for biomarker testing for diagnosis,
treatment, management, or ongoing monitoring of a recipient’s disease or condition to guide
treatment decisions when such testing provides clinical utility to the recipient as demonstrated by
medical and scientific evidence, including but not limited to, any of the following:
Labeled indications for a test approved or cleared by the United States FDA or indicated tests
for an FDA-approved drug.
Federal CMS national coverage determinations or Medicare Administrative Contractor local
coverage determinations.
Nationally recognized clinical practice guidelines.
The AHCA is also required to outline a process for enrollees and providers to access a process to
request an authorization for biomarker testing.
The biomarker testing services may not be construed to require coverage of biomarker testing for
screening purposes.
Section 3 creates s. 409.9745, F.S., to require managed care plans to provide coverage for
biomarker testing for enrollees, as authorized under s. 409.906, F.S., at the same scope, duration,
and frequency as the Medicaid program provides for other medically necessary treatments.
Managed care plans are required to outline a process for enrollees and providers to access a
process for requesting authorization of biomarker testing.
The bill provides that this provision may not be construed to require coverage of biomarker
testing for screening purposes.
Section 4 provides an effective date of July 1, 2024. BILL: CS/SB 964 Page 7
IV. Constitutional Issues:
A. Municipality/County Mandates Restrictions:
None.
B. Public Records/Open Meetings Issues:
None.
C. Trust Funds Restrictions:
None.
D. State Tax or Fee Increases:
None.
E. Other Constitutional Issues:
The bill requires the Medicaid fee for service and the Medicaid managed care plans and
the State Group Insurance program to cover biomarker testing for diagnosis, treatment,
management, and ongoing monitoring of a disease or condition of an enrollee to guide
treatment decisions when such testing provides clinical utility to the recipient and must
be demonstrated by medical and scientific evidence, including but not limited to:
Labeled indications for a test approved or cleared by the United States Food and Drug
Administration (FDA) or indicated tests for an FDA-approved drug.
Federal Centers for Medicare and Medicaid Services national coverage
determinations or Medicare Administrative Contractor local coverage determinations.
Nationally recognized clinical practice guidelines.
Use of the term “including but not limited to” indicates that the bill does not provide an
all-inclusive list for medical and scientific evidence, and it is unclear who would
determine the credibility or admissibility of it. Further, the term, “nationally recognized
clinical practice guidelines,” does not provide specific named guidelines or examples.
The bill provides no rulemaking authority, guidance or standards for the Agency for
Health Care Administration or the State Group Insurance program to use for establishing
this additional criteria. Thus, this additional, unspecified medical and scientific evidence
or guidelines for determining coverage may be an unlawful delegation of legislative
authority.
The Legislature may not delegate its constitutional duties to another branch of
government.
19
While the Legislature must make fundamental policy decisions, it may
delegate the task of implementing that policy to executive agencies with “some minimal
standards and guidelines ascertainable by reference to the enactment establishing the
19
See FLA. CONST. art. II, s. 3. BILL: CS/SB 964 Page 8
program.”
20
Moreover, the Legislature can permit “administration of legislative policy by
an agency with the expertise and flexibility to deal with complex and fluid conditions.”
21
Florida courts have found an unlawful delegation of legislative authority in the following
instances:
Where the Legislature allowed the Department of State to “in its discretion allow
such a candidate to withdraw…”;
22
and
Where the Legislature created a criminal penalty for escape from certain
classifications of juvenile detention facilities, but delegated the classification (or
determination whether to classify at all) to an agency.
23
V. Fiscal Impact Statement:
A. Tax/Fee Issues:
None.
B. Private Sector Impact:
Indeterminate. The mandated coverage is anticipated to reduce the overall costs of care of
an enrollee, insured, or subscriber as a result of the use of a more targeted, optimal
treatment protocol.
C. Government Sector Impact:
Florida’s Medicaid Program
24
The bill would limit the Agency for Health Care Administration’s (AHCA) ability to
determine coverage of biomarker testing using the current established process. The bill
could have both a significant operational and fiscal impact on the Medicaid Program as it
would require the AHCA to cover all codes that meet the clinical criteria defined by the
bill.
The bill mandates specific criteria by which biomarker testing must be evaluated for
coverage by Florida Medicaid. Currently, the AHCA does not define “specific nationally
recognized clinical practice guidelines” in rule for determining coverage. Covered
services must be medically necessary as defined by Rule 59G-1.010, F.A.C., not
duplicate another service, and meet the criteria in the service specific coverage policy.
When determining coverage or if it is appropriate to add a code to a FFS Medicaid fee
schedule, the AHCA considers clinical and practice guidelines as well as costs and
maintaining budget neutrality.
20
Askew v. Cross Key Waterways, 372 So.2d 913, 925 (Fla. 1978).
21
Microtel, Inc. v. Fla. Public Serv. Comm’n., 464 So.2d 1189, 1191 (Fla. 1991).
22
Fla. Dep’t. of State, Div. of Elections v. Martin, 916 So.2d 763 (Fla. 2005).
23
D.P. v. State, 597 So.2d 952 (Fla. 1st DCA, 1992)(disapproved on other grounds).
24
Correspondence from Patrick Steele, Legislative Affairs Director, Agency for Health Care Administration (Feb. 1, 2024).
On file with Senate Banking and Insurance Committee staff. BILL: CS/SB 964 Page 9
Typically, the AHCA does not cover every code designated by the American Medical
Association (AMA) for a covered service. For example, the Agency covers
integumentary and wound care supplies under s. 409.906 F.S., Optional Medicaid
services. There are a total of 87 skin substitute procedure codes listed in the AMA
Current Procedural Terminology (CPT) codebook. Of these, Florida Medicaid covers a
total of 26 CPT codes.
There are numerous biomarker tests that are Propriety Laboratory Analyses (PLA) CPT
codes. A PLA code is a descriptor for a lab or manufacturer that wants to identify its
proprietary test more specifically. Florida Medicaid currently covers 46 non-PLA
biomarker CPT codes under the Laboratory Services Fee Schedule that are listed on the
federal Centers for Medicare and Medicaid Services List for Billing and Coding:
Biomarkers for Oncology. Florida Medicaid does not typically include PLA codes on
FFS fee schedules.
As currently written, the bill requires the AHCA to cover every biomarker test when the
medical and scientific evidence, as outlined in the bill, indicates clinical utility to the
recipient. This requirement will have a significant fiscal impact to the Medicaid program
which is indeterminate and on-going as the number of PLA and non-PLA codes that
could meet this criteria is unknown. The impact will be ongoing as the bill will require
the AHCA to cover a biomarker test every time a new test meets the criteria outlined in
the bill.
State Group Insurance
The fiscal impact of the mandated coverage on the State Group Insurance is
indeterminate and may range from zero to $1.6 million annually.
25
It is unclear what
particular biomarker tests are currently covered and the criteria that is used to determine
coverage of such testing.
VI. Technical Deficiencies:
The additional coverage mandates and criteria for coverage created in ss. 409.906 and 409.9745,
F.S. appear to conflict with current coverage requirements of s. 409.905, F.S. Currently, s.
409.905, F.S., relating to the federal mandatory services, requires Florida’s fee for service and
Statewide Medicaid Managed Care to provide coverage for biomarker testing, subject to medical
necessity and other requirements. However, the bill requires Medicaid to provide coverage for
biomarker testing under the optional services required by the state but subject to an
appropriation, pursuant to s. 409.906, F.S. This would apply to fee for service, as well as
managed care plans. Like mandatory federal services, optional services under the Medicaid
program are subject to medical necessity and other requirements. However, the bill requires
coverage of biomarker testing when the testing provides clinical utility, which appears to be a
different standard than medical necessity.
25
Department of Management Services, 2024 Legislative Bill Analysis, Committee Substitute for House Bill 885 (Feb. 5,
2024)(on file with the Senate Appropriations Committee on Health and Human Services) BILL: CS/SB 964 Page 10
The bill provides that the medical and scientific evidence that may be used to determine if
biomarker testing provides clinical utility “includes, but is not limited to” certain specified items.
The use of the phrase “includes, but is not limited to” results in the bill being unclear what the
additional medical and scientific evidence would be that would require the coverage of a
biomarker test.
VII. Related Issues:
The bill takes effect on July 1, 2024. However, the Medicaid provider reimbursement fee
schedules are set on a plan year beginning October 1.
VIII. Statutes Affected:
This bill substantially amends sections 110.12303 and 409.906 of the Florida Statutes.
This bill creates section 409.9745 of the Florida Statutes.
IX. Additional Information:
A. Committee Substitute – Statement of Substantial Changes:
(Summarizing differences between the Committee Substitute and the prior version of the bill.)
CS by Banking and Insurance on February 6, 2024:
The committee substitute excludes commercial policies and contracts from the coverage
mandate. Such coverage is mandated for the Medicaid fee for service program and the
managed care plans and State Group Insurance.
B. Amendments:
None.
This Senate Bill Analysis does not reflect the intent or official position of the bill’s introducer or the Florida Senate.