Second Regular Session of the 123rd General Assembly (2024)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
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between statutes enacted by the 2023 Regular Session of the General Assembly.
SENATE ENROLLED ACT No. 273
AN ACT to amend the Indiana Code concerning insurance.
Be it enacted by the General Assembly of the State of Indiana:
SECTION 1. IC 12-15-5-21.5 IS ADDED TO THE INDIANA
CODE AS A NEW SECTION TO READ AS FOLLOWS
[EFFECTIVE JULY 1, 2024]: Sec. 21.5. (a) As used in this section,
"biomarker" means a characteristic that is objectively measured
and evaluated as an indicator of:
(1) normal biological processes;
(2) pathogenic processes; or
(3) pharmacologic responses to a specific therapeutic
intervention, including known gene-drug interactions for
medications being considered for use or already being
administered.
The term includes gene mutations, characteristics of genes, and
protein expression.
(b) As used in this section, "biomarker testing" means the
analysis of a patient's tissue, blood, or other biospecimen for the
presence of a biomarker. The term includes:
(1) single-analyte tests;
(2) multiplex panel tests;
(3) protein expression; and
(4) whole exome, whole genome, and whole transcriptome
sequencing.
(c) As used in this section, "consensus statement" means a
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statement that is:
(1) issued by an independent, multidisciplinary panel of
experts that:
(A) uses a transparent methodology and reporting
structure; and
(B) has a conflict of interest policy;
(2) aimed at specific clinical circumstances;
(3) based on the best available evidence; and
(4) developed for the purpose of optimizing the outcomes of
clinical care.
(d) As used in this section, "nationally recognized clinical
practice guidelines" means evidence based clinical practice
guidelines that:
(1) are developed by an independent organization or medical
professional society that:
(A) uses a transparent methodology and reporting
structure; and
(B) has a conflict of interest policy;
(2) establish standards of care informed by:
(A) a systematic review of evidence; and
(B) an assessment of the benefits and risks of alternative
care options; and
(3) include recommendations intended to optimize patient
care.
(e) The office shall provide, as a Medicaid program service,
biomarker testing for the purposes of diagnosis, treatment,
appropriate management, or ongoing monitoring of an enrollee's
disease or condition when biomarker testing is supported by
medical and scientific evidence, including:
(1) labeled indications for a test approved or cleared by the
United States Food and Drug Administration;
(2) indicated tests for a drug approved by the United States
Food and Drug Administration;
(3) a warning or precaution on the label of a drug approved
by the United States Food and Drug Administration;
(4) a national coverage determination of the Centers for
Medicare and Medicaid Services (CMS);
(5) a local coverage determination of a Medicare
administrative contractor; or
(6) nationally recognized clinical practice guidelines or
consensus statements.
The service required by this section must be provided in a manner
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that limits disruptions in care, including the need for multiple
biopsies or biospecimen samples.
(f) Nothing in this section shall be construed to require coverage
of biomarker testing for screening purposes.
(g) The office shall apply to the United States Department of
Health and Human Services for approval of any waiver necessary
under the federal Medicaid program for the purpose of providing
biomarker testing. The office may not implement a waiver under
this section until the office files an affidavit with the governor
attesting that the federal waiver applied for under this section is in
effect. The office shall file the affidavit under this subsection not
later than five (5) days after the office is notified that the waiver is
approved.
(h) If the office receives a waiver under this section from the
United States Department of Health and Human Services and the
governor receives the affidavit filed under subsection (g), the office
shall implement the waiver not more than sixty (60) days after the
governor receives the affidavit.
(i) Before November 1, 2025, and before November 1 of each
year thereafter, the office of the secretary shall report to the
budget committee on the Medicaid reimbursement rates provided
for biomarker testing. The report shall include the following
statewide aggregate information for the state fiscal year 2023 and
the state fiscal year most recently ended:
(1) The total number of patients who received biomarker
testing.
(2) The total number of patients who received biomarker
testing for each biomarker test type.
(3) The total amount of state funding expended for biomarker
testing.
(4) The ten (10) most common conditions or treatments for
which biomarker testing was ordered.
(5) As a result of the biomarker testing, how many patients:
(A) were placed on particular therapies;
(B) avoided certain treatments; and
(C) were subject to any other treatment impacts.
(6) Any other information requested by the budget committee.
Each provider that receives state Medicaid funding under this
section shall provide the information described in subdivisions (1)
through (6) to the office of the secretary not later than August 1 of
each year.
SECTION 2. IC 27-8-14.3 IS ADDED TO THE INDIANA CODE
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AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2024]:
Chapter 14.3. Coverage for Biomarker Testing
Sec. 1. This chapter applies to:
(1) a policy of accident and sickness insurance or a health
maintenance organization contract that is issued, renewed, or
entered into after June 30, 2024;
(2) Medicaid managed care provided by a managed care
organization under a contract with the office of Medicaid
policy and planning that is entered into or renewed after June
30, 2024; and
(3) coverage provided by a state employee health plan after
June 30, 2024.
Sec. 2. (a) As used in this chapter, "accident and sickness
policy" means an insurance policy that provides at least one (1) of
the types of insurance described in IC 27-1-5-1, Classes 1(b) and
2(a).
(b) The term "accident and sickness policy" does not include the
following:
(1) Accident only, credit, dental, vision, Medicare supplement,
long term care, or disability income insurance.
(2) Coverage issued as a supplement to liability insurance.
(3) Worker's compensation or similar insurance.
(4) Automobile medical payment insurance.
(5) A specified disease policy.
(6) A short term insurance plan that:
(A) may be renewed for the greater of:
(i) thirty-six (36) months; or
(ii) the maximum period permitted under federal law;
(B) has a term of not more than three hundred sixty-four
(364) days; and
(C) has an annual limit of at least two million dollars
($2,000,000).
(7) A policy that provides indemnity benefits not based on any
expense incurred requirement, including a plan that provides
coverage for:
(A) hospital confinement, critical illness, or intensive care;
or
(B) gaps for deductibles or copayments.
(8) A supplemental plan that always pays in addition to other
coverage.
(9) A student health plan.
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(10) An employer sponsored health benefit plan that is:
(A) provided to individuals who are eligible for Medicare;
and
(B) not marketed as, or held out to be, a Medicare
supplement policy.
Sec. 3. (a) As used in this chapter, "biomarker" means a
characteristic that is objectively measured and evaluated as an
indicator of:
(1) normal biological processes;
(2) pathogenic processes; or
(3) pharmacologic responses to a specific therapeutic
intervention, including known gene-drug interactions for
medications being considered for use or already being
administered.
(b) The term includes gene mutations, characteristics of genes,
and protein expression.
Sec. 4. (a) As used in this chapter, "biomarker testing" means
the analysis of a patient's tissue, blood, or other biospecimen for
the presence of a biomarker.
(b) The term includes:
(1) single-analyte tests;
(2) multiplex panel tests;
(3) protein expression; and
(4) whole exome, whole genome, and whole transcriptome
sequencing.
Sec. 5. As used in this chapter, "consensus statement" means a
statement that is:
(1) issued by an independent, multidisciplinary panel of
experts that:
(A) uses a transparent methodology and reporting
structure; and
(B) has a conflict of interest policy;
(2) aimed at specific clinical circumstances;
(3) based on the best available evidence; and
(4) developed for the purpose of optimizing the outcomes of
clinical care.
Sec. 6. As used in this chapter, "covered individual" means an
individual who is entitled to coverage under a health plan.
Sec. 7. (a) As used in this chapter, "health plan" means any of
the following:
(1) A policy of accident and sickness insurance.
(2) A contract with a health maintenance organization (as
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defined in IC 27-13-1-19) that provides coverage for basic
health care services (as defined in IC 27-13-1-4).
(3) The Medicaid risk based managed care program operated
under IC 12-15.
(4) A state employee health plan.
(b) The term includes a person that administers a health plan.
Sec. 8. As used in this chapter, "nationally recognized clinical
practice guidelines" means evidence based clinical practice
guidelines that:
(1) are developed by an independent organization or medical
professional society that:
(A) uses a transparent methodology and reporting
structure; and
(B) has a conflict of interest policy;
(2) establish standards of care informed by:
(A) a systematic review of evidence; and
(B) an assessment of the benefits and risks of alternative
care options; and
(3) include recommendations intended to optimize patient
care.
Sec. 9. (a) As used in this chapter, "state employee health plan"
refers to either of the following:
(1) A self-insurance program established under
IC 5-10-8-7(b).
(2) A contract with a prepaid health care delivery plan that is
entered into or renewed under IC 5-10-8-7(c).
(b) The term includes a person that administers prescription
drug benefits on behalf of a state employee health plan.
Sec. 10. (a) A health plan shall provide coverage for biomarker
testing for the purposes of diagnosis, treatment, appropriate
management, or ongoing monitoring of an enrollee's disease or
condition when biomarker testing is supported by medical and
scientific evidence, including:
(1) labeled indications for a test approved or cleared by the
United States Food and Drug Administration;
(2) indicated tests for a drug approved by the United States
Food and Drug Administration;
(3) a warning or precaution on the label of a drug approved
by the United States Food and Drug Administration;
(4) a national coverage determination of the Centers for
Medicare and Medicaid Services (CMS);
(5) a local coverage determination of a Medicare
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administrative contractor; or
(6) nationally recognized clinical practice guidelines or
consensus statements.
(b) The coverage required by this section must be provided in a
manner that limits disruptions in care, including the need for
multiple biopsies or biospecimen samples.
(c) Nothing in this section shall be construed to require coverage
of biomarker testing for screening purposes.
(d) If a prior authorization requirement applies to biomarker
testing under a health plan, the health plan or a third party acting
on behalf of the health plan must:
(1) approve or deny a request for prior authorization for
biomarker testing; and
(2) notify the covered individual and any person requesting
prior authorization of the biomarker testing on behalf of the
covered individual;
in not more than five (5) business days after the request in the case
of a nonurgent request or in not more than forty-eight (48) hours
after the request in the case of an urgent request.
(e) A health plan shall ensure that a covered individual and the
practitioner who prescribes biomarker testing for the covered
individual have access to a clear, readily accessible, and convenient
process for requesting an exception to:
(1) a coverage policy; or
(2) a prior authorization determination;
of the health plan that is adverse to the coverage of biomarker
testing for the covered individual. The process required by this
subsection shall be made readily accessible on the health plan's
website.
SEA 273 President of the Senate
President Pro Tempore
Speaker of the House of Representatives
Governor of the State of Indiana
Date: Time:
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