*SB0273.2*
February 2, 2024
SENATE BILL No. 273
_____
DIGEST OF SB 273 (Updated February 1, 2024 11:53 am - DI 129)
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,
(Continued next page)
Effective: July 1, 2024.
Charbonneau, Becker, Leising,
Qaddoura, Bohacek, Bassler, Glick,
Ford J.D., Randolph Lonnie M, Yoder
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.
February 1, 2024, amended, reported favorably — Do Pass.
SB 273—LS 6648/DI 55 Digest Continued
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.
Requires the office of the secretary of family and social services to
report certain information to the budget committee on Medicaid
reimbursement rates provided for biomarker testing.
SB 273—LS 6648/DI 55SB 273—LS 6648/DI 55 February 2, 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 (i) Before November 1, 2025, and before November 1 of each
25 year thereafter, the office of the secretary shall report to the
26 budget committee on the Medicaid reimbursement rates provided
27 for biomarker testing. The report shall include the following
28 statewide aggregate information for the state fiscal year 2023 and
29 the state fiscal year most recently ended:
30 (1) The total number of patients who received biomarker
31 testing.
32 (2) The total number of patients who received biomarker
33 testing for each biomarker test type.
34 (3) The total amount of state funding expended for biomarker
35 testing.
36 (4) The ten (10) most common conditions or treatments for
37 which biomarker testing was ordered.
38 (5) As a result of the biomarker testing, how many patients:
39 (A) were placed on particular therapies;
40 (B) avoided certain treatments; and
41 (C) were subject to any other treatment impacts.
42 (6) Any other information requested by the budget committee.
SB 273—LS 6648/DI 55 4
1 Each provider that receives state Medicaid funding under this
2 section shall provide the information described in subdivisions (1)
3 through (6) to the office of the secretary not later than August 1 of
4 each year.
5 SECTION 2. IC 27-8-14.3 IS ADDED TO THE INDIANA CODE
6 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
7 JULY 1, 2024]:
8 Chapter 14.3. Coverage for Biomarker Testing
9 Sec. 1. This chapter applies to:
10 (1) a policy of accident and sickness insurance or a health
11 maintenance organization contract that is issued, renewed, or
12 entered into after June 30, 2024;
13 (2) Medicaid managed care provided by a managed care
14 organization under a contract with the office of Medicaid
15 policy and planning that is entered into or renewed after June
16 30, 2024; and
17 (3) coverage provided by a state employee health plan after
18 June 30, 2024.
19 Sec. 2. (a) As used in this chapter, "accident and sickness
20 policy" means an insurance policy that provides at least one (1) of
21 the types of insurance described in IC 27-1-5-1, Classes 1(b) and
22 2(a).
23 (b) The term "accident and sickness policy" does not include the
24 following:
25 (1) Accident only, credit, dental, vision, Medicare supplement,
26 long term care, or disability income insurance.
27 (2) Coverage issued as a supplement to liability insurance.
28 (3) Worker's compensation or similar insurance.
29 (4) Automobile medical payment insurance.
30 (5) A specified disease policy.
31 (6) A short term insurance plan that:
32 (A) may be renewed for the greater of:
33 (i) thirty-six (36) months; or
34 (ii) the maximum period permitted under federal law;
35 (B) has a term of not more than three hundred sixty-four
36 (364) days; and
37 (C) has an annual limit of at least two million dollars
38 ($2,000,000).
39 (7) A policy that provides indemnity benefits not based on any
40 expense incurred requirement, including a plan that provides
41 coverage for:
42 (A) hospital confinement, critical illness, or intensive care;
SB 273—LS 6648/DI 55 5
1 or
2 (B) gaps for deductibles or copayments.
3 (8) A supplemental plan that always pays in addition to other
4 coverage.
5 (9) A student health plan.
6 (10) An employer sponsored health benefit plan that is:
7 (A) provided to individuals who are eligible for Medicare;
8 and
9 (B) not marketed as, or held out to be, a Medicare
10 supplement policy.
11 Sec. 3. (a) As used in this chapter, "biomarker" means a
12 characteristic that is objectively measured and evaluated as an
13 indicator of:
14 (1) normal biological processes;
15 (2) pathogenic processes; or
16 (3) pharmacologic responses to a specific therapeutic
17 intervention, including known gene-drug interactions for
18 medications being considered for use or already being
19 administered.
20 (b) The term includes gene mutations, characteristics of genes,
21 and protein expression.
22 Sec. 4. (a) As used in this chapter, "biomarker testing" means
23 the analysis of a patient's tissue, blood, or other biospecimen for
24 the presence of a biomarker.
25 (b) The term includes:
26 (1) single-analyte tests;
27 (2) multiplex panel tests;
28 (3) protein expression; and
29 (4) whole exome, whole genome, and whole transcriptome
30 sequencing.
31 Sec. 5. As used in this chapter, "consensus statement" means a
32 statement that is:
33 (1) issued by an independent, multidisciplinary panel of
34 experts that:
35 (A) uses a transparent methodology and reporting
36 structure; and
37 (B) has a conflict of interest policy;
38 (2) aimed at specific clinical circumstances;
39 (3) based on the best available evidence; and
40 (4) developed for the purpose of optimizing the outcomes of
41 clinical care.
42 Sec. 6. As used in this chapter, "covered individual" means an
SB 273—LS 6648/DI 55 6
1 individual who is entitled to coverage under a health plan.
2 Sec. 7. (a) As used in this chapter, "health plan" means any of
3 the following:
4 (1) A policy of accident and sickness insurance.
5 (2) A contract with a health maintenance organization (as
6 defined in IC 27-13-1-19) that provides coverage for basic
7 health care services (as defined in IC 27-13-1-4).
8 (3) The Medicaid risk based managed care program operated
9 under IC 12-15.
10 (4) A state employee health plan.
11 (b) The term includes a person that administers a health plan.
12 Sec. 8. As used in this chapter, "nationally recognized clinical
13 practice guidelines" means evidence based clinical practice
14 guidelines that:
15 (1) are developed by an independent organization or medical
16 professional society that:
17 (A) uses a transparent methodology and reporting
18 structure; and
19 (B) has a conflict of interest policy;
20 (2) establish standards of care informed by:
21 (A) a systematic review of evidence; and
22 (B) an assessment of the benefits and risks of alternative
23 care options; and
24 (3) include recommendations intended to optimize patient
25 care.
26 Sec. 9. (a) As used in this chapter, "state employee health plan"
27 refers to either of the following:
28 (1) A self-insurance program established under
29 IC 5-10-8-7(b).
30 (2) A contract with a prepaid health care delivery plan that is
31 entered into or renewed under IC 5-10-8-7(c).
32 (b) The term includes a person that administers prescription
33 drug benefits on behalf of a state employee health plan.
34 Sec. 10. (a) A health plan shall provide coverage for biomarker
35 testing for the purposes of diagnosis, treatment, appropriate
36 management, or ongoing monitoring of an enrollee's disease or
37 condition when biomarker testing is supported by medical and
38 scientific evidence, including:
39 (1) labeled indications for a test approved or cleared by the
40 United States Food and Drug Administration;
41 (2) indicated tests for a drug approved by the United States
42 Food and Drug Administration;
SB 273—LS 6648/DI 55 7
1 (3) a warning or precaution on the label of a drug approved
2 by the United States Food and Drug Administration;
3 (4) a national coverage determination of the Centers for
4 Medicare and Medicaid Services (CMS);
5 (5) a local coverage determination of a Medicare
6 administrative contractor; or
7 (6) nationally recognized clinical practice guidelines or
8 consensus statements.
9 (b) The coverage required by this section must be provided in a
10 manner that limits disruptions in care, including the need for
11 multiple biopsies or biospecimen samples.
12 (c) Nothing in this section shall be construed to require coverage
13 of biomarker testing for screening purposes.
14 (d) If a prior authorization requirement applies to biomarker
15 testing under a health plan, the health plan or a third party acting
16 on behalf of the health plan must:
17 (1) approve or deny a request for prior authorization for
18 biomarker testing; and
19 (2) notify the covered individual and any person requesting
20 prior authorization of the biomarker testing on behalf of the
21 covered individual;
22 in not more than five (5) business days after the request in the case
23 of a nonurgent request or in not more than forty-eight (48) hours
24 after the request in the case of an urgent request.
25 (e) A health plan shall ensure that a covered individual and the
26 practitioner who prescribes biomarker testing for the covered
27 individual have access to a clear, readily accessible, and convenient
28 process for requesting an exception to:
29 (1) a coverage policy; or
30 (2) a prior authorization determination;
31 of the health plan that is adverse to the coverage of biomarker
32 testing for the covered individual. The process required by this
33 subsection shall be made readily accessible on the health plan's
34 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.
_____
COMMITTEE REPORT
Madam President: The Senate Committee on Appropriations, 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 23 and 24, begin a new paragraph and insert:
"(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
SB 273—LS 6648/DI 55 9
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.".
and when so amended that said bill do pass.
(Reference is to SB 273 as printed January 19, 2024.)
MISHLER, Chairperson
Committee Vote: Yeas 13, Nays 0.
SB 273—LS 6648/DI 55