HOUSE OF REPRESENTATIVES STAFF ANALYSIS
BILL #: CS/CS/HB 885 Coverage for Biomarker Testing
SPONSOR(S): Health & Human Services Committee, Select Committee on Health Innovation, Gonzalez
Pittman and others
TIED BILLS: IDEN./SIM. BILLS: CS/SB 964
REFERENCE ACTION ANALYST STAFF DIRECTOR or
BUDGET/POLICY
CHIEF
1) Select Committee on Health Innovation 15 Y, 0 N, As CS Lloyd Calamas
2) Appropriations Committee 27 Y, 0 N Smith Pridgeon
3) Health & Human Services Committee 17 Y, 0 N, As CS Lloyd Calamas
SUMMARY ANALYSIS
Biomarker testing is a method of looking for any structure, process, genes, proteins, or other substance in the
body that can provide information that can be measured in the body or its products and influence or predict the
incidence of outcome or disease. It is a type of personalized or precision medicine where medical care is
tailored to a person’s specific genes, proteins, and other substances which may be present in a person’s body.
Biomarker testing is not helpful for all kinds of diseases. With cancer, for example, biomarker testing can help
show:
Whether the cancer is likely to grow or spread;
Whether certain types of cancer treatments may be more likely or unlikely to be helpful; and
Whether the cancer treatment is working.
Different types of biomarker tests can be done to help determine the best cancer treatment options or what
treatment options are not helpful. Many tests look for gene changes in the cancer cells, while some measure
certain proteins or other kinds of markers.
Biomarker testing for other diseases may look at just a single biomarker or check for many biomarkers at the
same time (such as patterns of certain genes or proteins). Some tests look at all of the genes inside cancer
cells. Biomarker tests may be done on tumor samples removed during a biopsy or surgery, but some
biomarker tests can be done on samples of blood or other bodily fluids.
CS/CS/HB 885 would require coverage for biomarker testing in Medicaid and the state group health insurance
program. A recipient or insured and health care providers must have access to a clear and convenient process
to request authorization for such testing through a readily accessible website of the insurer or plan. Coverage
would not be required for biomarker testing for screening purposes.
The bill has an indeterminate, insignificant negative fiscal impact on state government. See Fiscal Analysis.
The bill provides an effective date of July 1, 2024, except for the provisions related to Medicaid, which are
effective October 1, 2024.
This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives .
STORAGE NAME: h0885f.HHS
DATE: 2/23/2024
FULL ANALYSIS
I. SUBSTANTIVE ANALYSIS
A. EFFECT OF PROPOSED CHANGES:
Background
Biomarker Testing
Biomarker testing is a way of looking for genes, proteins, and other substances in the body that can
provide information about diseases, such as cancer.1 In 1988, the International Programme on
Chemical Safety, led by the World Health Organization (WHO) and in coordination with the United
Nations and the International Labor Organization, defined a biomarker as “any substance, structure, or
process that can be measured in the body or its products and influence or predict the incidence of
outcome or disease”.2
An even broader definition of biomarker testing considers not just the incidence and outcome of
disease, but also the effects of treatments, interventions, and even unintended environmental
exposure, such as to chemicals or nutrients. In its report on the validity of biomarkers in environment
risk assessment, the WHO has stated that a true definition of biomarkers includes “almost any
measurement reflecting an interaction between a biological system and a potential hazard, which may
be chemical, physical, or biological.3 Biomarker testing is also a type of personalized or precision
medicine where medical care is tailored to a person’s specific genes, proteins, and other substances
which may be present in a person’s body.4
Biomarker testing is not helpful for every kind of disease, but in the example of biomarker testing for
cancer, such testing can help show:
Whether the cancer is likely to grow or spread.
Whether certain types of cancer treatments may be more likely or unlikely to be helpful.
Whether the cancer treatment is working.5
Studies indicate that currently only half of patients with cancer in the United States for whom biomarker
testing is recommended receive biomarker testing.6 More than a quarter of patients who did not receive
recommended biomarker testing reported that it was because insurance was not covering the test at all
and/or they would have incurred high out-of-pocket costs.7
Different types of biomarker tests can be done to help determine the best cancer treatment options.
Many tests look for gene changes in the cancer cells, while some measure certain proteins or other
kinds of markers. Other tests may look at just a single biomarker or check for many biomarkers at the
same time (such as patterns of certain genes or proteins). Some tests look at all of the genes inside
cancer cells.8
Biomarker tests may be done on tumor samples removed during a biopsy or surgery, but some
biomarker tests can be done on samples of blood or other bodily fluids without being as invasive.9 For
certain types of cancer, biomarker testing is done routinely to assist with treatment decisions. Some
1
National Cancer Institute, Biomarker Testing for Cancer, Biomarker Testing for Cancer Treatment - NCI (last visited February 6, 2024).
2
Kyle Strimbu and Jorge Tavel, M.D., What are biomarkers? Curr Opin HIV AIDS. 2010 Nov; 5(6): 463–466, available at
doi: 10.1097/COH.0b013e32833ed177 (last visited February 6, 2024).
3
Id.
4
American Cancer Society, Biomarker Tests and Cancer Treatment, available Biomarker Tests and Cancer Treatment | American Cancer Society (last
visited February 6, 2024).
5
Id.
6
Chaw la A, Peeples M,Li N, Anhorn R, Ryan J,Signorovitch J., Real-world utilization of molecular diagnostic testing and matched drug therapies in the
treatment of metastatic cancers, J Med Econ. 2018; 21:543-552, available at Real-w orld utilization of molecular diagnostic testing and matched drug
therapies in the treatment of metastatic cancers - PubMed (nih.gov) (last visited February 6, 2024).
7
Improving access to biomarker testing. American Cancer Society Cancer Action Netw ork. Published September 28, 2020, available at Improving
Access to Biomarker Testing | American Cancer Society Cancer Action Netw ork (fightcancer.org) (last visited February 6, 2024).
8
Supra, note 4.
9
Id.
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cancer treatments, such as targeted therapies and immunotherapies, may only work for individuals with
certain type of cancers.10 However, biomarker testing may not be appropriate or helpful in all such
situations. Using cancer as an example, the most common types of cancer for biomarker testing include
cancers where there are changes in designated genes for:
Non-small cell lung cancer;
Breast cancer;
Colorectal cancer; and
Melanoma skin cancer.11
Biomarker testing is conducted using a sample of an individual’s cancer cells, where the cells are
analyzed to identify the specific biomarkers. The lab’s report on the specific biomarkers will also identify
the treatments that may be helpful for the cancer or the cancer strains identified. Some biomarker tests
also require a testing of healthy cells for comparison of a person’s healthy cells to his or her cancer
cells for different mutations.12
One type of biomarker that can be identified is a driver mutation, which is a change in the DNA of a
cancer cell and can cause a cancer cell to overgrow or a normal cell to become a cancer cell. The other
type of biomarker is an immunotherapy biomarker, which may be found on the surface of a cancer cell
and impacts how the cancer cells interact with the immune system. Knowing the types of biomarkers an
individual has aids in the individual’s plan of care.13
A number of types of biomarker tests for molecularly targeted therapies are in clinical use, ranging from
single-gene tests to guide the use of a single class of therapy to a suite of multiple, but separate, tests
for single analytes to guide the use of multiple therapy options in a specific clinical context for
something like breast cancer treatment.14 Multiple-gene panels include additional analytes for other
clinical or research purposes, including assessing secondary response or resistance to targeted
therapies, multiplex panel tests, protein express, and whole exome, whole genome, and whole
transcriptome sequencing.15
Growth in this area of medicine has grown exponentially. For genome-informed therapy, the number of
tests available or eligible for testing since 2018 has increased from 16 percent to 27 percent in 2020.16
From January 1, 2006, when tracking of such approval began at the federal Food and Drug
Administration (FDA), through June 30, 2020, 51 different drugs had been approved for 36 genomic
indications covering 18 cancer types.17
Results of a biomarker test can help an individual find different options for treatment through the FDA-
approved treatment regimens, off-label treatments, or clinical trials. Knowing that a cancer does not
have certain biomarkers can also save a patient from undergoing unnecessary treatment or treatment
that has not been as successful in a particular diagnosis or not have a long-term result leading to the
return of the cancer.18
Waiting for results from biomarker tests before determining treatment options can provide patients and
their providers more information on which to make decisions. Results from testing can take up to four
10
Supra, note 1.
11
Supra, note 4.
12
Id.
13
Genentech, Understanding Biomarkers, available at Learn About Biomarkers And Biomarker Testing in Advanced Non-Small Cell Lung Cancer |
MyCareRoadMap By Genentech (last visited February 6, 2024).
14
Laurene A, Graig, et al, Biomarker Tests for Molecularly Targeted Therapies, Institute of Medicine, The Nat’l Academies of Science, Engineering &
Medicine (2016), available at Biomarker Tests for Molecularly Targeted Therapies. Key to Unlocking Precision Medicine (nih.gov) (last visited February
6, 2024).
15
Id.
16
Genomic testing for targeted oncology drugs: hopes against hype, Editorial, Annals of Oncology, (Vol. 32, Iss.7, 2021), available at Genomic testing
for targeted oncology drugs: hopes against hype (annalsofoncology.org) (last visited February 6, 2024).
17
A. Haslam, M.S. Kim, & V. Presad, Updated Estimates of Eligibility for and Responses to Genome Targeted Oncology Drugs Among US Cancer
Patients; Annals of Oncoloy (Vol. 32, Issue 7, July 2021; 926:943), available at Updated estimates of eligibility for and response to genome-targeted
oncology drugs among US cancer patients, 2006-2020 - Annals of Oncology (last visited February 6, 2024).
18
Supra, note 4.
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weeks or longer to receive.19 A patient may also have biomarker testing more than once during
treatment to determine the efficacy of a treatment or if other options need to be considered. 20
In 2020, the FDA approved two liquid biopsy tests that help guide treatment therapies for individuals
with any solid tumor cancer, but not those with a blood cancer. These two approved tests can c heck for
multiple cancer related mutations and are considered less invasive and quicker than the typical needle
biopsy.21 One test, Guardant360 CDX, checks for changes in more than 60 genes, while the other
approved test, FoundationOne Liquid CDx, can identify changes in more than 300 genes.22 Medicare
does provide coverage for two FDA-approved tests, but coverage by private insurance companies for
these same tests is not consistent.
Costs of Biomarker Testing
The costs of biomarker testing vary based on the type of testing being conducted and the type of
disease being tested. The average allowed unit cost to insurers per biomarker test ranges from $78.71
(Medicaid) to $224.40 (large group self-insured).23
One study published in November 2022 found that among those with biomarker tests, the median per-
patient total payer lifetime costs of all biomarker testing were $394/$462 (lung/metastatic lung) and
$148/$232 (thyroid/metastatic thyroid).24 In this study, total lifetime biomarker costs for payers ranged
from a median of $128 (consumer-driven health plans) to $477 (preferred provider organizations).
Median lifetime patient out-of-pocket costs were $0.00 for both tumor types and all payer types except
for consumer-driven health plans ($12 for thyroid and $10 for metastatic lung). 25
Costs vary by type of testing. The FDA has provided marketing approval for the sale of direct to patient
biomarker tests. One of these tests, which was approved in 2019, can identify cancer-associated
alterations in 324 genes in any type of solid tumor. 26 Different levels of screening tests can be ordered
by a patient directly online or by a patient’s health care provider for $299 - $350 for the cost of the test
– not including the cost of analysis or review by the practitioner. 27
For new cancer treatments, costs may be covered as part of clinical trials. If an individual participates in
a clinical trial, costs of the testing are usually covered as part of participation.28 Increasingly, clinical
trials report the enrollment of individuals based on the specific genetic mutation or alteration and not
which organ the cancer originated from.29
State Employee Health Plan Coverage
The Department of Management Services (DMS) through the Division of State Group Insurance (DSGI)
under the authority of section 110.123, F.S., administers the state group health insurance program
(Program) for state employees, retirees, and their families. The Program is a cafeteria plan managed
19
LUNGevity, Biomarker testing can help you get the best treatment for your lung cancer, 353b8753a58e4ebaae940e2d4b95ca49
(d2zd6ny1q7rvh6.cloudfront.net) (last visited February 6, 2024).
20
Id.
21
National Cancer Institute, FDA Approves Cancer Test Which Can Help Guide Cancer Treatment (October 15, 2020) FDA Approves Blood Tests That
Can Help Guide Cancer Treatment - NCI (last visited February 6, 2024).
22
Id.
23
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, available at doi: 10.1016/j.jval.2018.04.1372, Epub 2018 Jun 8. PMID: 30442274.
(last visited February 6, 2024).
24
Lisa M. Hess, et al., Costs of biomarker testing among patients with metastatic lung or thyroid cancer in the USA: a real -world commercial claims
database study, J Med Econ 2023 Jan-Dec;26(1):43-50., available at Costs of biomarker testing among patients w ith metastatic lung or thyroid cancer in
the USA: a real-w orld commercial claims database study - PubMed (nih.gov) (last visited February 6, 2024).
25
Id.
26
National Cancer Institute, Genomic Profiling Tests Cleared by FDA Can Help Guide Cancer Treatment, Clinical Trial Enrollment (December 21, 2017),
https://www.cancer.gov/news-events/cancer-currents-blog/2017/genomic-profiling-tests-cancer, (last visited February 6, 2024).
28
Id.
28
Supra, note 4.
29
National Cancer Institute, Genomic Profiling Tests Cleared by FDA Can Help Guide Cancer Treatment, Clinical Trial Enrollment (December 21, 2017)
available at FDA Approves Tw o Genomic Profiling Tests for Cancer - NCI (last visited February 6, 2024).
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DATE: 2/23/2024
consistent with section 125 of the Internal Revenue Code. 30 To administer the program, DSGI contracts
with third party administrators for self-insured plans, a fully insured HMO, and a pharmacy benefits
manager for the state employees’ self-insured prescription drug program, pursuant to s. 110.12315,
F.S.
The state group health insurance program delivers benefits through contracts it competitively bids for
on regular contract cycles with health insurers, health maintenance organizations, and third party
administrators. The current benefits and premium rates for the plan year of January 1, 2024 through
December 31, 2024 are established in these contracts