*SB0273.1*
January 19, 2024
SENATE BILL No. 273
_____
DIGEST OF SB 273 (Updated January 17, 2024 1:34 pm - DI 55)
Citations Affected: IC 12-15; IC 27-8.
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.
Provides that coverage is not required for biomarker testing for
screening purposes. Provides that if a prior authorization requirement
applies to biomarker testing, the health plan or a third party acting on
behalf of the health plan must: (1) approve or deny a request for prior
authorization; and (2) notify the covered individual of the approval or
denial; in not more than five business days in the case of a nonurgent
request or in not more than 48 hours in the case of an urgent request.
Effective: July 1, 2024.
Charbonneau, Becker, Leising,
Qaddoura
January 11, 2024, read first time and referred to Committee on Insurance and Financial
Institutions.
January 18, 2024, amended, reported favorably — Do Pass; reassigned to Committee on
Appropriations.
SB 273—LS 6648/DI 55 January 19, 2024
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;
SB 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);
SB 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) Nothing in this section shall be construed to require coverage
9 of biomarker testing for screening purposes.
10 (g) The office shall apply to the United States Department of
11 Health and Human Services for approval of any waiver necessary
12 under the federal Medicaid program for the purpose of providing
13 biomarker testing. The office may not implement a waiver under
14 this section until the office files an affidavit with the governor
15 attesting that the federal waiver applied for under this section is in
16 effect. The office shall file the affidavit under this subsection not
17 later than five (5) days after the office is notified that the waiver is
18 approved.
19 (h) If the office receives a waiver under this section from the
20 United States Department of Health and Human Services and the
21 governor receives the affidavit filed under subsection (g), the office
22 shall implement the waiver not more than sixty (60) days after the
23 governor receives the affidavit.
24 SECTION 2. IC 27-8-14.3 IS ADDED TO THE INDIANA CODE
25 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
26 JULY 1, 2024]:
27 Chapter 14.3. Coverage for Biomarker Testing
28 Sec. 1. This chapter applies to:
29 (1) a policy of accident and sickness insurance or a health
30 maintenance organization contract that is issued, renewed, or
31 entered into after June 30, 2024;
32 (2) Medicaid managed care provided by a managed care
33 organization under a contract with the office of Medicaid
34 policy and planning that is entered into or renewed after June
35 30, 2024; and
36 (3) coverage provided by a state employee health plan after
37 June 30, 2024.
38 Sec. 2. (a) As used in this chapter, "accident and sickness
39 policy" means an insurance policy that provides at least one (1) of
40 the types of insurance described in IC 27-1-5-1, Classes 1(b) and
41 2(a).
42 (b) The term "accident and sickness policy" does not include the
SB 273—LS 6648/DI 55 4
1 following:
2 (1) Accident only, credit, dental, vision, Medicare supplement,
3 long term care, or disability income insurance.
4 (2) Coverage issued as a supplement to liability insurance.
5 (3) Worker's compensation or similar insurance.
6 (4) Automobile medical payment insurance.
7 (5) A specified disease policy.
8 (6) A short term insurance plan that:
9 (A) may be renewed for the greater of:
10 (i) thirty-six (36) months; or
11 (ii) the maximum period permitted under federal law;
12 (B) has a term of not more than three hundred sixty-four
13 (364) days; and
14 (C) has an annual limit of at least two million dollars
15 ($2,000,000).
16 (7) A policy that provides indemnity benefits not based on any
17 expense incurred requirement, including a plan that provides
18 coverage for:
19 (A) hospital confinement, critical illness, or intensive care;
20 or
21 (B) gaps for deductibles or copayments.
22 (8) A supplemental plan that always pays in addition to other
23 coverage.
24 (9) A student health plan.
25 (10) An employer sponsored health benefit plan that is:
26 (A) provided to individuals who are eligible for Medicare;
27 and
28 (B) not marketed as, or held out to be, a Medicare
29 supplement policy.
30 Sec. 3. (a) As used in this chapter, "biomarker" means a
31 characteristic that is objectively measured and evaluated as an
32 indicator of:
33 (1) normal biological processes;
34 (2) pathogenic processes; or
35 (3) pharmacologic responses to a specific therapeutic
36 intervention, including known gene-drug interactions for
37 medications being considered for use or already being
38 administered.
39 (b) The term includes gene mutations, characteristics of genes,
40 and protein expression.
41 Sec. 4. (a) As used in this chapter, "biomarker testing" means
42 the analysis of a patient's tissue, blood, or other biospecimen for
SB 273—LS 6648/DI 55 5
1 the presence of a biomarker.
2 (b) The term includes:
3 (1) single-analyte tests;
4 (2) multiplex panel tests;
5 (3) protein expression; and
6 (4) whole exome, whole genome, and whole transcriptome
7 sequencing.
8 Sec. 5. As used in this chapter, "consensus statement" means a
9 statement that is:
10 (1) issued by an independent, multidisciplinary panel of
11 experts that:
12 (A) uses a transparent methodology and reporting
13 structure; and
14 (B) has a conflict of interest policy;
15 (2) aimed at specific clinical circumstances;
16 (3) based on the best available evidence; and
17 (4) developed for the purpose of optimizing the outcomes of
18 clinical care.
19 Sec. 6. As used in this chapter, "covered individual" means an
20 individual who is entitled to coverage under a health plan.
21 Sec. 7. (a) As used in this chapter, "health plan" means any of
22 the following:
23 (1) A policy of accident and sickness insurance.
24 (2) A contract with a health maintenance organization (as
25 defined in IC 27-13-1-19) that provides coverage for basic
26 health care services (as defined in IC 27-13-1-4).
27 (3) The Medicaid risk based managed care program operated
28 under IC 12-15.
29 (4) A state employee health plan.
30 (b) The term includes a person that administers a health plan.
31 Sec. 8. As used in this chapter, "nationally recognized clinical
32 practice guidelines" means evidence based clinical practice
33 guidelines that:
34 (1) are developed by an independent organization or medical
35 professional society that:
36 (A) uses a transparent methodology and reporting
37 structure; and
38 (B) has a conflict of interest policy;
39 (2) establish standards of care informed by:
40 (A) a systematic review of evidence; and
41 (B) an assessment of the benefits and risks of alternative
42 care options; and
SB 273—LS 6648/DI 55 6
1 (3) include recommendations intended to optimize patient
2 care.
3 Sec. 9. (a) As used in this chapter, "state employee health plan"
4 refers to either of the following:
5 (1) A self-insurance program established under
6 IC 5-10-8-7(b).
7 (2) A contract with a prepaid health care delivery plan that is
8 entered into or renewed under IC 5-10-8-7(c).
9 (b) The term includes a person that administers prescription
10 drug benefits on behalf of a state employee health plan.
11 Sec. 10. (a) A health plan shall provide coverage for biomarker
12 testing for the purposes of diagnosis, treatment, appropriate
13 management, or ongoing monitoring of an enrollee's disease or
14 condition when biomarker testing is supported by medical and
15 scientific evidence, including:
16 (1) labeled indications for a test approved or cleared by the
17 United States Food and Drug Administration;
18 (2) indicated tests for a drug approved by the United States
19 Food and Drug Administration;
20 (3) a warning or precaution on the label of a drug approved
21 by the United States Food and Drug Administration;
22 (4) a national coverage determination of the Centers for
23 Medicare and Medicaid Services (CMS);
24 (5) a local coverage determination of a Medicare
25 administrative contractor; or
26 (6) nationally recognized clinical practice guidelines or
27 consensus statements.
28 (b) The coverage required by this section must be provided in a
29 manner that limits disruptions in care, including the need for
30 multiple biopsies or biospecimen samples.
31 (c) Nothing in this section shall be construed to require coverage
32 of biomarker testing for screening purposes.
33 (d) If a prior authorization requirement applies to biomarker
34 testing under a health plan, the health plan or a third party acting
35 on behalf of the health plan must:
36 (1) approve or deny a request for prior authorization for
37 biomarker testing; and
38 (2) notify the covered individual and any person requesting
39 prior authorization of the biomarker testing on behalf of the
40 covered individual;
41 in not more than five (5) business days after the request in the case
42 of a nonurgent request or in not more than forty-eight (48) hours
SB 273—LS 6648/DI 55 7
1 after the request in the case of an urgent request.
2 (e) A health plan shall ensure that a covered individual and the
3 practitioner who prescribes biomarker testing for the covered
4 individual have access to a clear, readily accessible, and convenient
5 process for requesting an exception to:
6 (1) a coverage policy; or
7 (2) a prior authorization determination;
8 of the health plan that is adverse to the coverage of biomarker
9 testing for the covered individual. The process required by this
10 subsection shall be made readily accessible on the health plan's
11 website.
SB 273—LS 6648/DI 55 8
COMMITTEE REPORT
Madam President: The Senate Committee on Insurance and
Financial Institutions, to which was referred Senate Bill No. 273, has
had the same under consideration and begs leave to report the same
back to the Senate with the recommendation that said bill be
AMENDED as follows:
Page 3, between lines 7 and 8, begin a new paragraph and insert:
"(f) Nothing in this section shall be construed to require
coverage of biomarker testing for screening purposes.".
Page 3, line 8, delete "(f)" and insert "(g)".
Page 3, line 17, delete "(g)" and insert "(h)".
Page 3, line 19, delete "(f)," and insert "(g),".
Page 6, between lines 28 and 29, begin a new paragraph and insert:
"(c) Nothing in this section shall be construed to require
coverage of biomarker testing for screening purposes.".
Page 6, line 29, delete "(c)" and insert "(d)".
Page 6, line 37, delete "seventy-two (72) hours" and insert "five (5)
business days".
Page 6, line 38, delete "twenty-four (24)" and insert "forty-eight
(48)".
Page 6, line 40, delete "(d)" and insert "(e)".
and when so amended that said bill do pass and be reassigned to the
Senate Committee on Appropriations.
(Reference is to SB 273 as introduced.)
BALDWIN, Chairperson
Committee Vote: Yeas 8, Nays 1.
SB 273—LS 6648/DI 55