Introduced Version
SENATE BILL No. 273
_____
DIGEST OF INTRODUCED BILL
Citations Affected: IC 12-15-5-21.5; IC 27-8-14.3.
Synopsis: Biomarker testing coverage. Requires a health plan (which
includes a policy of accident and sickness insurance, a health
maintenance organization contract, the Medicaid risk based managed
care program, and a state employee health plan) to 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. Requires the office of Medicaid policy and
planning to provide biomarker testing as a Medicaid program service,
and to 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.
Effective: July 1, 2024.
Charbonneau, Becker
January 11, 2024, read first time and referred to Committee on Insurance and Financial
Institutions.
2024 IN 273—LS 6648/DI 55 Introduced
Second Regular Session of the 123rd General Assembly (2024)
PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
Constitution) is being amended, the text of the existing provision will appear in this style type,
additions will appear in this style type, and deletions will appear in this style type.
Additions: Whenever a new statutory provision is being enacted (or a new constitutional
provision adopted), the text of the new provision will appear in this style type. Also, the
word NEW will appear in that style type in the introductory clause of each SECTION that adds
a new provision to the Indiana Code or the Indiana Constitution.
Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
between statutes enacted by the 2023 Regular Session of the General Assembly.
SENATE BILL No. 273
A BILL FOR AN ACT to amend the Indiana Code concerning
insurance.
Be it enacted by the General Assembly of the State of Indiana:
1 SECTION 1. IC 12-15-5-21.5 IS ADDED TO THE INDIANA
2 CODE AS A NEW SECTION TO READ AS FOLLOWS
3 [EFFECTIVE JULY 1, 2024]: Sec. 21.5. (a) As used in this section,
4 "biomarker" means a characteristic that is objectively measured
5 and evaluated as an indicator of:
6 (1) normal biological processes;
7 (2) pathogenic processes; or
8 (3) pharmacologic responses to a specific therapeutic
9 intervention, including known gene-drug interactions for
10 medications being considered for use or already being
11 administered.
12 The term includes gene mutations, characteristics of genes, and
13 protein expression.
14 (b) As used in this section, "biomarker testing" means the
15 analysis of a patient's tissue, blood, or other biospecimen for the
16 presence of a biomarker. The term includes:
17 (1) single-analyte tests;
2024 IN 273—LS 6648/DI 55 2
1 (2) multiplex panel tests;
2 (3) protein expression; and
3 (4) whole exome, whole genome, and whole transcriptome
4 sequencing.
5 (c) As used in this section, "consensus statement" means a
6 statement that is:
7 (1) issued by an independent, multidisciplinary panel of
8 experts that:
9 (A) uses a transparent methodology and reporting
10 structure; and
11 (B) has a conflict of interest policy;
12 (2) aimed at specific clinical circumstances;
13 (3) based on the best available evidence; and
14 (4) developed for the purpose of optimizing the outcomes of
15 clinical care.
16 (d) As used in this section, "nationally recognized clinical
17 practice guidelines" means evidence based clinical practice
18 guidelines that:
19 (1) are developed by an independent organization or medical
20 professional society that:
21 (A) uses a transparent methodology and reporting
22 structure; and
23 (B) has a conflict of interest policy;
24 (2) establish standards of care informed by:
25 (A) a systematic review of evidence; and
26 (B) an assessment of the benefits and risks of alternative
27 care options; and
28 (3) include recommendations intended to optimize patient
29 care.
30 (e) The office shall provide, as a Medicaid program service,
31 biomarker testing for the purposes of diagnosis, treatment,
32 appropriate management, or ongoing monitoring of an enrollee's
33 disease or condition when biomarker testing is supported by
34 medical and scientific evidence, including:
35 (1) labeled indications for a test approved or cleared by the
36 United States Food and Drug Administration;
37 (2) indicated tests for a drug approved by the United States
38 Food and Drug Administration;
39 (3) a warning or precaution on the label of a drug approved
40 by the United States Food and Drug Administration;
41 (4) a national coverage determination of the Centers for
42 Medicare and Medicaid Services (CMS);
2024 IN 273—LS 6648/DI 55 3
1 (5) a local coverage determination of a Medicare
2 administrative contractor; or
3 (6) nationally recognized clinical practice guidelines or
4 consensus statements.
5 The service required by this section must be provided in a manner
6 that limits disruptions in care, including the need for multiple
7 biopsies or biospecimen samples.
8 (f) The office shall apply to the United States Department of
9 Health and Human Services for approval of any waiver necessary
10 under the federal Medicaid program for the purpose of providing
11 biomarker testing. The office may not implement a waiver under
12 this section until the office files an affidavit with the governor
13 attesting that the federal waiver applied for under this section is in
14 effect. The office shall file the affidavit under this subsection not
15 later than five (5) days after the office is notified that the waiver is
16 approved.
17 (g) If the office receives a waiver under this section from the
18 United States Department of Health and Human Services and the
19 governor receives the affidavit filed under subsection (f), the office
20 shall implement the waiver not more than sixty (60) days after the
21 governor receives the affidavit.
22 SECTION 2. IC 27-8-14.3 IS ADDED TO THE INDIANA CODE
23 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
24 JULY 1, 2024]:
25 Chapter 14.3. Coverage for Biomarker Testing
26 Sec. 1. This chapter applies to:
27 (1) a policy of accident and sickness insurance or a health
28 maintenance organization contract that is issued, renewed, or
29 entered into after June 30, 2024;
30 (2) Medicaid managed care provided by a managed care
31 organization under a contract with the office of Medicaid
32 policy and planning that is entered into or renewed after June
33 30, 2024; and
34 (3) coverage provided by a state employee health plan after
35 June 30, 2024.
36 Sec. 2. (a) As used in this chapter, "accident and sickness
37 policy" means an insurance policy that provides at least one (1) of
38 the types of insurance described in IC 27-1-5-1, Classes 1(b) and
39 2(a).
40 (b) The term "accident and sickness policy" does not include the
41 following:
42 (1) Accident only, credit, dental, vision, Medicare supplement,
2024 IN 273—LS 6648/DI 55 4
1 long term care, or disability income insurance.
2 (2) Coverage issued as a supplement to liability insurance.
3 (3) Worker's compensation or similar insurance.
4 (4) Automobile medical payment insurance.
5 (5) A specified disease policy.
6 (6) A short term insurance plan that:
7 (A) may be renewed for the greater of:
8 (i) thirty-six (36) months; or
9 (ii) the maximum period permitted under federal law;
10 (B) has a term of not more than three hundred sixty-four
11 (364) days; and
12 (C) has an annual limit of at least two million dollars
13 ($2,000,000).
14 (7) A policy that provides indemnity benefits not based on any
15 expense incurred requirement, including a plan that provides
16 coverage for:
17 (A) hospital confinement, critical illness, or intensive care;
18 or
19 (B) gaps for deductibles or copayments.
20 (8) A supplemental plan that always pays in addition to other
21 coverage.
22 (9) A student health plan.
23 (10) An employer sponsored health benefit plan that is:
24 (A) provided to individuals who are eligible for Medicare;
25 and
26 (B) not marketed as, or held out to be, a Medicare
27 supplement policy.
28 Sec. 3. (a) As used in this chapter, "biomarker" means a
29 characteristic that is objectively measured and evaluated as an
30 indicator of:
31 (1) normal biological processes;
32 (2) pathogenic processes; or
33 (3) pharmacologic responses to a specific therapeutic
34 intervention, including known gene-drug interactions for
35 medications being considered for use or already being
36 administered.
37 (b) The term includes gene mutations, characteristics of genes,
38 and protein expression.
39 Sec. 4. (a) As used in this chapter, "biomarker testing" means
40 the analysis of a patient's tissue, blood, or other biospecimen for
41 the presence of a biomarker.
42 (b) The term includes:
2024 IN 273—LS 6648/DI 55 5
1 (1) single-analyte tests;
2 (2) multiplex panel tests;
3 (3) protein expression; and
4 (4) whole exome, whole genome, and whole transcriptome
5 sequencing.
6 Sec. 5. As used in this chapter, "consensus statement" means a
7 statement that is:
8 (1) issued by an independent, multidisciplinary panel of
9 experts that:
10 (A) uses a transparent methodology and reporting
11 structure; and
12 (B) has a conflict of interest policy;
13 (2) aimed at specific clinical circumstances;
14 (3) based on the best available evidence; and
15 (4) developed for the purpose of optimizing the outcomes of
16 clinical care.
17 Sec. 6. As used in this chapter, "covered individual" means an
18 individual who is entitled to coverage under a health plan.
19 Sec. 7. (a) As used in this chapter, "health plan" means any of
20 the following:
21 (1) A policy of accident and sickness insurance.
22 (2) A contract with a health maintenance organization (as
23 defined in IC 27-13-1-19) that provides coverage for basic
24 health care services (as defined in IC 27-13-1-4).
25 (3) The Medicaid risk based managed care program operated
26 under IC 12-15.
27 (4) A state employee health plan.
28 (b) The term includes a person that administers a health plan.
29 Sec. 8. As used in this chapter, "nationally recognized clinical
30 practice guidelines" means evidence based clinical practice
31 guidelines that:
32 (1) are developed by an independent organization or medical
33 professional society that:
34 (A) uses a transparent methodology and reporting
35 structure; and
36 (B) has a conflict of interest policy;
37 (2) establish standards of care informed by:
38 (A) a systematic review of evidence; and
39 (B) an assessment of the benefits and risks of alternative
40 care options; and
41 (3) include recommendations intended to optimize patient
42 care.
2024 IN 273—LS 6648/DI 55 6
1 Sec. 9. (a) As used in this chapter, "state employee health plan"
2 refers to either of the following:
3 (1) A self-insurance program established under
4 IC 5-10-8-7(b).
5 (2) A contract with a prepaid health care delivery plan that is
6 entered into or renewed under IC 5-10-8-7(c).
7 (b) The term includes a person that administers prescription
8 drug benefits on behalf of a state employee health plan.
9 Sec. 10. (a) A health plan shall provide coverage for biomarker
10 testing for the purposes of diagnosis, treatment, appropriate
11 management, or ongoing monitoring of an enrollee's disease or
12 condition when biomarker testing is supported by medical and
13 scientific evidence, including:
14 (1) labeled indications for a test approved or cleared by the
15 United States Food and Drug Administration;
16 (2) indicated tests for a drug approved by the United States
17 Food and Drug Administration;
18 (3) a warning or precaution on the label of a drug approved
19 by the United States Food and Drug Administration;
20 (4) a national coverage determination of the Centers for
21 Medicare and Medicaid Services (CMS);
22 (5) a local coverage determination of a Medicare
23 administrative contractor; or
24 (6) nationally recognized clinical practice guidelines or
25 consensus statements.
26 (b) The coverage required by this section must be provided in a
27 manner that limits disruptions in care, including the need for
28 multiple biopsies or biospecimen samples.
29 (c) If a prior authorization requirement applies to biomarker
30 testing under a health plan, the health plan or a third party acting
31 on behalf of the health plan must:
32 (1) approve or deny a request for prior authorization for
33 biomarker testing; and
34 (2) notify the covered individual and any person requesting
35 prior authorization of the biomarker testing on behalf of the
36 covered individual;
37 in not more than seventy-two (72) hours after the request in the
38 case of a nonurgent request or in not more than twenty-four (24)
39 hours after the request in the case of an urgent request.
40 (d) A health plan shall ensure that a covered individual and the
41 practitioner who prescribes biomarker testing for the covered
42 individual have access to a clear, readily accessible, and convenient
2024 IN 273—LS 6648/DI 55 7
1 process for requesting an exception to:
2 (1) a coverage policy; or
3 (2) a prior authorization determination;
4 of the health plan that is adverse to the coverage of biomarker
5 testing for the covered individual. The process required by this
6 subsection shall be made readily accessible on the health plan's
7 website.
2024 IN 273—LS 6648/DI 55