Indiana 2024 Regular Session

Indiana Senate Bill SB0273 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
	1	+	ES0273.2
	2	+	February 22, 2024
	3	+	ENGROSSED
	4	+	SENATE BILL No. 273
	5	+	_____
	6	+	DIGEST OF SB 273 (Updated February 21, 2024 2:02 pm - DI 140)
	7	+	Citations Affected: IC 12-15; IC 27-8.
	8	+	Synopsis: Biomarker testing coverage. Requires a health plan (which
	9	+	includes a policy of accident and sickness insurance, a health
	10	+	maintenance organization contract, the Medicaid risk based managed
	11	+	care program, and a state employee health plan) to provide coverage for
	12	+	biomarker testing for the purposes of diagnosis, treatment, appropriate
	13	+	management, or ongoing monitoring of an enrollee's disease or
	14	+	(Continued next page)
	15	+	Effective: July 1, 2024.
	16	+	Charbonneau, Becker, Leising,
	17	+	Qaddoura, Bohacek, Bassler, Glick,
	18	+	Ford J.D., Randolph Lonnie M, Yoder
	19	+	(HOUSE SPONSORS — BARRETT, CLERE, PORTER, LEHMAN)
	20	+	January 11, 2024, read first time and referred to Committee on Insurance and Financial
	21	+	Institutions.
	22	+	January 18, 2024, amended, reported favorably — Do Pass; reassigned to Committee on
	23	+	Appropriations.
	24	+	February 1, 2024, amended, reported favorably — Do Pass.
	25	+	February 5, 2024, read second time, ordered engrossed. Engrossed.
	26	+	February 6, 2024, read third time, passed. Yeas 47, nays 1.
	27	+	HOUSE ACTION
	28	+	February 12, 2024, read first time and referred to Committee on Insurance.
	29	+	February 15, 2024, reported — Do Pass. Referred to Committee on Ways and Means
	30	+	pursuant to Rule 127.
	31	+	February 22, 2024, reported — Do Pass.
	32	+	ES 273—LS 6648/DI 55 Digest Continued
	33	+	condition when biomarker testing is supported by medical and
	34	+	scientific evidence. Requires the office of Medicaid policy and
	35	+	planning to provide biomarker testing as a Medicaid program service,
	36	+	and to apply to the United States Department of Health and Human
	37	+	Services for approval of any waiver necessary under the federal
	38	+	Medicaid program for the purpose of providing biomarker testing.
	39	+	Provides that coverage is not required for biomarker testing for
	40	+	screening purposes. Provides that if a prior authorization requirement
	41	+	applies to biomarker testing, the health plan or a third party acting on
	42	+	behalf of the health plan must: (1) approve or deny a request for prior
	43	+	authorization; and (2) notify the covered individual of the approval or
	44	+	denial; in not more than five business days in the case of a nonurgent
	45	+	request or in not more than 48 hours in the case of an urgent request.
	46	+	Requires the office of the secretary of family and social services to
	47	+	report certain information to the budget committee on Medicaid
	48	+	reimbursement rates provided for biomarker testing.
	49	+	ES 273—LS 6648/DI 55ES 273—LS 6648/DI 55 February 22, 2024
1	50		Second Regular Session of the 123rd General Assembly (2024)
2	51		PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
3	52		Constitution) is being amended, the text of the existing provision will appear in this style type,
4	53		additions will appear in this style type, and deletions will appear in this style type.
5	54		Additions: Whenever a new statutory provision is being enacted (or a new constitutional
6	55		provision adopted), the text of the new provision will appear in this style type. Also, the
7	56		word NEW will appear in that style type in the introductory clause of each SECTION that adds
8	57		a new provision to the Indiana Code or the Indiana Constitution.
9	58		Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
10	59		between statutes enacted by the 2023 Regular Session of the General Assembly.
11		-	SENATE ENROLLED ACT No. 273
12		-	AN ACT to amend the Indiana Code concerning insurance.
	60	+	ENGROSSED
	61	+	SENATE BILL No. 273
	62	+	A BILL FOR AN ACT to amend the Indiana Code concerning
	63	+	insurance.
13	64		Be it enacted by the General Assembly of the State of Indiana:
14		-	SECTION 1. IC 12-15-5-21.5 IS ADDED TO THE INDIANA
15		-	CODE AS A NEW SECTION TO READ AS FOLLOWS
16		-	[EFFECTIVE JULY 1, 2024]: Sec. 21.5. (a) As used in this section,
17		-	"biomarker" means a characteristic that is objectively measured
18		-	and evaluated as an indicator of:
19		-	(1) normal biological processes;
20		-	(2) pathogenic processes; or
21		-	(3) pharmacologic responses to a specific therapeutic
22		-	intervention, including known gene-drug interactions for
23		-	medications being considered for use or already being
24		-	administered.
25		-	The term includes gene mutations, characteristics of genes, and
26		-	protein expression.
27		-	(b) As used in this section, "biomarker testing" means the
28		-	analysis of a patient's tissue, blood, or other biospecimen for the
29		-	presence of a biomarker. The term includes:
30		-	(1) single-analyte tests;
31		-	(2) multiplex panel tests;
32		-	(3) protein expression; and
33		-	(4) whole exome, whole genome, and whole transcriptome
34		-	sequencing.
35		-	(c) As used in this section, "consensus statement" means a
36		-	SEA 273 2
37		-	statement that is:
38		-	(1) issued by an independent, multidisciplinary panel of
39		-	experts that:
40		-	(A) uses a transparent methodology and reporting
41		-	structure; and
42		-	(B) has a conflict of interest policy;
43		-	(2) aimed at specific clinical circumstances;
44		-	(3) based on the best available evidence; and
45		-	(4) developed for the purpose of optimizing the outcomes of
46		-	clinical care.
47		-	(d) As used in this section, "nationally recognized clinical
48		-	practice guidelines" means evidence based clinical practice
49		-	guidelines that:
50		-	(1) are developed by an independent organization or medical
51		-	professional society that:
52		-	(A) uses a transparent methodology and reporting
53		-	structure; and
54		-	(B) has a conflict of interest policy;
55		-	(2) establish standards of care informed by:
56		-	(A) a systematic review of evidence; and
57		-	(B) an assessment of the benefits and risks of alternative
58		-	care options; and
59		-	(3) include recommendations intended to optimize patient
60		-	care.
61		-	(e) The office shall provide, as a Medicaid program service,
62		-	biomarker testing for the purposes of diagnosis, treatment,
63		-	appropriate management, or ongoing monitoring of an enrollee's
64		-	disease or condition when biomarker testing is supported by
65		-	medical and scientific evidence, including:
66		-	(1) labeled indications for a test approved or cleared by the
67		-	United States Food and Drug Administration;
68		-	(2) indicated tests for a drug approved by the United States
69		-	Food and Drug Administration;
70		-	(3) a warning or precaution on the label of a drug approved
71		-	by the United States Food and Drug Administration;
72		-	(4) a national coverage determination of the Centers for
73		-	Medicare and Medicaid Services (CMS);
74		-	(5) a local coverage determination of a Medicare
75		-	administrative contractor; or
76		-	(6) nationally recognized clinical practice guidelines or
77		-	consensus statements.
78		-	The service required by this section must be provided in a manner
79		-	SEA 273 3
80		-	that limits disruptions in care, including the need for multiple
81		-	biopsies or biospecimen samples.
82		-	(f) Nothing in this section shall be construed to require coverage
83		-	of biomarker testing for screening purposes.
84		-	(g) The office shall apply to the United States Department of
85		-	Health and Human Services for approval of any waiver necessary
86		-	under the federal Medicaid program for the purpose of providing
87		-	biomarker testing. The office may not implement a waiver under
88		-	this section until the office files an affidavit with the governor
89		-	attesting that the federal waiver applied for under this section is in
90		-	effect. The office shall file the affidavit under this subsection not
91		-	later than five (5) days after the office is notified that the waiver is
92		-	approved.
93		-	(h) If the office receives a waiver under this section from the
94		-	United States Department of Health and Human Services and the
95		-	governor receives the affidavit filed under subsection (g), the office
96		-	shall implement the waiver not more than sixty (60) days after the
97		-	governor receives the affidavit.
98		-	(i) Before November 1, 2025, and before November 1 of each
	65	+	1 SECTION 1. IC 12-15-5-21.5 IS ADDED TO THE INDIANA
	66	+	2 CODE AS A NEW SECTION TO READ AS FOLLOWS
	67	+	3 [EFFECTIVE JULY 1, 2024]: Sec. 21.5. (a) As used in this section,
	68	+	4 "biomarker" means a characteristic that is objectively measured
	69	+	5 and evaluated as an indicator of:
	70	+	6 (1) normal biological processes;
	71	+	7 (2) pathogenic processes; or
	72	+	8 (3) pharmacologic responses to a specific therapeutic
	73	+	9 intervention, including known gene-drug interactions for
	74	+	10 medications being considered for use or already being
	75	+	11 administered.
	76	+	12 The term includes gene mutations, characteristics of genes, and
	77	+	13 protein expression.
	78	+	14 (b) As used in this section, "biomarker testing" means the
	79	+	15 analysis of a patient's tissue, blood, or other biospecimen for the
	80	+	16 presence of a biomarker. The term includes:
	81	+	17 (1) single-analyte tests;
	82	+	ES 273—LS 6648/DI 55 2
	83	+	1 (2) multiplex panel tests;
	84	+	2 (3) protein expression; and
	85	+	3 (4) whole exome, whole genome, and whole transcriptome
	86	+	4 sequencing.
	87	+	5 (c) As used in this section, "consensus statement" means a
	88	+	6 statement that is:
	89	+	7 (1) issued by an independent, multidisciplinary panel of
	90	+	8 experts that:
	91	+	9 (A) uses a transparent methodology and reporting
	92	+	10 structure; and
	93	+	11 (B) has a conflict of interest policy;
	94	+	12 (2) aimed at specific clinical circumstances;
	95	+	13 (3) based on the best available evidence; and
	96	+	14 (4) developed for the purpose of optimizing the outcomes of
	97	+	15 clinical care.
	98	+	16 (d) As used in this section, "nationally recognized clinical
	99	+	17 practice guidelines" means evidence based clinical practice
	100	+	18 guidelines that:
	101	+	19 (1) are developed by an independent organization or medical
	102	+	20 professional society that:
	103	+	21 (A) uses a transparent methodology and reporting
	104	+	22 structure; and
	105	+	23 (B) has a conflict of interest policy;
	106	+	24 (2) establish standards of care informed by:
	107	+	25 (A) a systematic review of evidence; and
	108	+	26 (B) an assessment of the benefits and risks of alternative
	109	+	27 care options; and
	110	+	28 (3) include recommendations intended to optimize patient
	111	+	29 care.
	112	+	30 (e) The office shall provide, as a Medicaid program service,
	113	+	31 biomarker testing for the purposes of diagnosis, treatment,
	114	+	32 appropriate management, or ongoing monitoring of an enrollee's
	115	+	33 disease or condition when biomarker testing is supported by
	116	+	34 medical and scientific evidence, including:
	117	+	35 (1) labeled indications for a test approved or cleared by the
	118	+	36 United States Food and Drug Administration;
	119	+	37 (2) indicated tests for a drug approved by the United States
	120	+	38 Food and Drug Administration;
	121	+	39 (3) a warning or precaution on the label of a drug approved
	122	+	40 by the United States Food and Drug Administration;
	123	+	41 (4) a national coverage determination of the Centers for
	124	+	42 Medicare and Medicaid Services (CMS);
	125	+	ES 273—LS 6648/DI 55 3
	126	+	1 (5) a local coverage determination of a Medicare
	127	+	2 administrative contractor; or
	128	+	3 (6) nationally recognized clinical practice guidelines or
	129	+	4 consensus statements.
	130	+	5 The service required by this section must be provided in a manner
	131	+	6 that limits disruptions in care, including the need for multiple
	132	+	7 biopsies or biospecimen samples.
	133	+	8 (f) Nothing in this section shall be construed to require coverage
	134	+	9 of biomarker testing for screening purposes.
	135	+	10 (g) The office shall apply to the United States Department of
	136	+	11 Health and Human Services for approval of any waiver necessary
	137	+	12 under the federal Medicaid program for the purpose of providing
	138	+	13 biomarker testing. The office may not implement a waiver under
	139	+	14 this section until the office files an affidavit with the governor
	140	+	15 attesting that the federal waiver applied for under this section is in
	141	+	16 effect. The office shall file the affidavit under this subsection not
	142	+	17 later than five (5) days after the office is notified that the waiver is
	143	+	18 approved.
	144	+	19 (h) If the office receives a waiver under this section from the
	145	+	20 United States Department of Health and Human Services and the
	146	+	21 governor receives the affidavit filed under subsection (g), the office
	147	+	22 shall implement the waiver not more than sixty (60) days after the
	148	+	23 governor receives the affidavit.
	149	+	24 (i) Before November 1, 2025, and before November 1 of each
	150	+	25 year thereafter, the office of the secretary shall report to the
	151	+	26 budget committee on the Medicaid reimbursement rates provided
	152	+	27 for biomarker testing. The report shall include the following
	153	+	28 statewide aggregate information for the state fiscal year 2023 and
	154	+	29 the state fiscal year most recently ended:
	155	+	30 (1) The total number of patients who received biomarker
	156	+	31 testing.
	157	+	32 (2) The total number of patients who received biomarker
	158	+	33 testing for each biomarker test type.
	159	+	34 (3) The total amount of state funding expended for biomarker
	160	+	35 testing.
	161	+	36 (4) The ten (10) most common conditions or treatments for
	162	+	37 which biomarker testing was ordered.
	163	+	38 (5) As a result of the biomarker testing, how many patients:
	164	+	39 (A) were placed on particular therapies;
	165	+	40 (B) avoided certain treatments; and
	166	+	41 (C) were subject to any other treatment impacts.
	167	+	42 (6) Any other information requested by the budget committee.
	168	+	ES 273—LS 6648/DI 55 4
	169	+	1 Each provider that receives state Medicaid funding under this
	170	+	2 section shall provide the information described in subdivisions (1)
	171	+	3 through (6) to the office of the secretary not later than August 1 of
	172	+	4 each year.
	173	+	5 SECTION 2. IC 27-8-14.3 IS ADDED TO THE INDIANA CODE
	174	+	6 AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
	175	+	7 JULY 1, 2024]:
	176	+	8 Chapter 14.3. Coverage for Biomarker Testing
	177	+	9 Sec. 1. This chapter applies to:
	178	+	10 (1) a policy of accident and sickness insurance or a health
	179	+	11 maintenance organization contract that is issued, renewed, or
	180	+	12 entered into after June 30, 2024;
	181	+	13 (2) Medicaid managed care provided by a managed care
	182	+	14 organization under a contract with the office of Medicaid
	183	+	15 policy and planning that is entered into or renewed after June
	184	+	16 30, 2024; and
	185	+	17 (3) coverage provided by a state employee health plan after
	186	+	18 June 30, 2024.
	187	+	19 Sec. 2. (a) As used in this chapter, "accident and sickness
	188	+	20 policy" means an insurance policy that provides at least one (1) of
	189	+	21 the types of insurance described in IC 27-1-5-1, Classes 1(b) and
	190	+	22 2(a).
	191	+	23 (b) The term "accident and sickness policy" does not include the
	192	+	24 following:
	193	+	25 (1) Accident only, credit, dental, vision, Medicare supplement,
	194	+	26 long term care, or disability income insurance.
	195	+	27 (2) Coverage issued as a supplement to liability insurance.
	196	+	28 (3) Worker's compensation or similar insurance.
	197	+	29 (4) Automobile medical payment insurance.
	198	+	30 (5) A specified disease policy.
	199	+	31 (6) A short term insurance plan that:
	200	+	32 (A) may be renewed for the greater of:
	201	+	33 (i) thirty-six (36) months; or
	202	+	34 (ii) the maximum period permitted under federal law;
	203	+	35 (B) has a term of not more than three hundred sixty-four
	204	+	36 (364) days; and
	205	+	37 (C) has an annual limit of at least two million dollars
	206	+	38 ($2,000,000).
	207	+	39 (7) A policy that provides indemnity benefits not based on any
	208	+	40 expense incurred requirement, including a plan that provides
	209	+	41 coverage for:
	210	+	42 (A) hospital confinement, critical illness, or intensive care;
	211	+	ES 273—LS 6648/DI 55 5
	212	+	1 or
	213	+	2 (B) gaps for deductibles or copayments.
	214	+	3 (8) A supplemental plan that always pays in addition to other
	215	+	4 coverage.
	216	+	5 (9) A student health plan.
	217	+	6 (10) An employer sponsored health benefit plan that is:
	218	+	7 (A) provided to individuals who are eligible for Medicare;
	219	+	8 and
	220	+	9 (B) not marketed as, or held out to be, a Medicare
	221	+	10 supplement policy.
	222	+	11 Sec. 3. (a) As used in this chapter, "biomarker" means a
	223	+	12 characteristic that is objectively measured and evaluated as an
	224	+	13 indicator of:
	225	+	14 (1) normal biological processes;
	226	+	15 (2) pathogenic processes; or
	227	+	16 (3) pharmacologic responses to a specific therapeutic
	228	+	17 intervention, including known gene-drug interactions for
	229	+	18 medications being considered for use or already being
	230	+	19 administered.
	231	+	20 (b) The term includes gene mutations, characteristics of genes,
	232	+	21 and protein expression.
	233	+	22 Sec. 4. (a) As used in this chapter, "biomarker testing" means
	234	+	23 the analysis of a patient's tissue, blood, or other biospecimen for
	235	+	24 the presence of a biomarker.
	236	+	25 (b) The term includes:
	237	+	26 (1) single-analyte tests;
	238	+	27 (2) multiplex panel tests;
	239	+	28 (3) protein expression; and
	240	+	29 (4) whole exome, whole genome, and whole transcriptome
	241	+	30 sequencing.
	242	+	31 Sec. 5. As used in this chapter, "consensus statement" means a
	243	+	32 statement that is:
	244	+	33 (1) issued by an independent, multidisciplinary panel of
	245	+	34 experts that:
	246	+	35 (A) uses a transparent methodology and reporting
	247	+	36 structure; and
	248	+	37 (B) has a conflict of interest policy;
	249	+	38 (2) aimed at specific clinical circumstances;
	250	+	39 (3) based on the best available evidence; and
	251	+	40 (4) developed for the purpose of optimizing the outcomes of
	252	+	41 clinical care.
	253	+	42 Sec. 6. As used in this chapter, "covered individual" means an
	254	+	ES 273—LS 6648/DI 55 6
	255	+	1 individual who is entitled to coverage under a health plan.
	256	+	2 Sec. 7. (a) As used in this chapter, "health plan" means any of
	257	+	3 the following:
	258	+	4 (1) A policy of accident and sickness insurance.
	259	+	5 (2) A contract with a health maintenance organization (as
	260	+	6 defined in IC 27-13-1-19) that provides coverage for basic
	261	+	7 health care services (as defined in IC 27-13-1-4).
	262	+	8 (3) The Medicaid risk based managed care program operated
	263	+	9 under IC 12-15.
	264	+	10 (4) A state employee health plan.
	265	+	11 (b) The term includes a person that administers a health plan.
	266	+	12 Sec. 8. As used in this chapter, "nationally recognized clinical
	267	+	13 practice guidelines" means evidence based clinical practice
	268	+	14 guidelines that:
	269	+	15 (1) are developed by an independent organization or medical
	270	+	16 professional society that:
	271	+	17 (A) uses a transparent methodology and reporting
	272	+	18 structure; and
	273	+	19 (B) has a conflict of interest policy;
	274	+	20 (2) establish standards of care informed by:
	275	+	21 (A) a systematic review of evidence; and
	276	+	22 (B) an assessment of the benefits and risks of alternative
	277	+	23 care options; and
	278	+	24 (3) include recommendations intended to optimize patient
	279	+	25 care.
	280	+	26 Sec. 9. (a) As used in this chapter, "state employee health plan"
	281	+	27 refers to either of the following:
	282	+	28 (1) A self-insurance program established under
	283	+	29 IC 5-10-8-7(b).
	284	+	30 (2) A contract with a prepaid health care delivery plan that is
	285	+	31 entered into or renewed under IC 5-10-8-7(c).
	286	+	32 (b) The term includes a person that administers prescription
	287	+	33 drug benefits on behalf of a state employee health plan.
	288	+	34 Sec. 10. (a) A health plan shall provide coverage for biomarker
	289	+	35 testing for the purposes of diagnosis, treatment, appropriate
	290	+	36 management, or ongoing monitoring of an enrollee's disease or
	291	+	37 condition when biomarker testing is supported by medical and
	292	+	38 scientific evidence, including:
	293	+	39 (1) labeled indications for a test approved or cleared by the
	294	+	40 United States Food and Drug Administration;
	295	+	41 (2) indicated tests for a drug approved by the United States
	296	+	42 Food and Drug Administration;
	297	+	ES 273—LS 6648/DI 55 7
	298	+	1 (3) a warning or precaution on the label of a drug approved
	299	+	2 by the United States Food and Drug Administration;
	300	+	3 (4) a national coverage determination of the Centers for
	301	+	4 Medicare and Medicaid Services (CMS);
	302	+	5 (5) a local coverage determination of a Medicare
	303	+	6 administrative contractor; or
	304	+	7 (6) nationally recognized clinical practice guidelines or
	305	+	8 consensus statements.
	306	+	9 (b) The coverage required by this section must be provided in a
	307	+	10 manner that limits disruptions in care, including the need for
	308	+	11 multiple biopsies or biospecimen samples.
	309	+	12 (c) Nothing in this section shall be construed to require coverage
	310	+	13 of biomarker testing for screening purposes.
	311	+	14 (d) If a prior authorization requirement applies to biomarker
	312	+	15 testing under a health plan, the health plan or a third party acting
	313	+	16 on behalf of the health plan must:
	314	+	17 (1) approve or deny a request for prior authorization for
	315	+	18 biomarker testing; and
	316	+	19 (2) notify the covered individual and any person requesting
	317	+	20 prior authorization of the biomarker testing on behalf of the
	318	+	21 covered individual;
	319	+	22 in not more than five (5) business days after the request in the case
	320	+	23 of a nonurgent request or in not more than forty-eight (48) hours
	321	+	24 after the request in the case of an urgent request.
	322	+	25 (e) A health plan shall ensure that a covered individual and the
	323	+	26 practitioner who prescribes biomarker testing for the covered
	324	+	27 individual have access to a clear, readily accessible, and convenient
	325	+	28 process for requesting an exception to:
	326	+	29 (1) a coverage policy; or
	327	+	30 (2) a prior authorization determination;
	328	+	31 of the health plan that is adverse to the coverage of biomarker
	329	+	32 testing for the covered individual. The process required by this
	330	+	33 subsection shall be made readily accessible on the health plan's
	331	+	34 website.
	332	+	ES 273—LS 6648/DI 55 8
	333	+	COMMITTEE REPORT
	334	+	Madam President: The Senate Committee on Insurance and
	335	+	Financial Institutions, to which was referred Senate Bill No. 273, has
	336	+	had the same under consideration and begs leave to report the same
	337	+	back to the Senate with the recommendation that said bill be
	338	+	AMENDED as follows:
	339	+	Page 3, between lines 7 and 8, begin a new paragraph and insert:
	340	+	"(f) Nothing in this section shall be construed to require
	341	+	coverage of biomarker testing for screening purposes.".
	342	+	Page 3, line 8, delete "(f)" and insert "(g)".
	343	+	Page 3, line 17, delete "(g)" and insert "(h)".
	344	+	Page 3, line 19, delete "(f)," and insert "(g),".
	345	+	Page 6, between lines 28 and 29, begin a new paragraph and insert:
	346	+	"(c) Nothing in this section shall be construed to require
	347	+	coverage of biomarker testing for screening purposes.".
	348	+	Page 6, line 29, delete "(c)" and insert "(d)".
	349	+	Page 6, line 37, delete "seventy-two (72) hours" and insert "five (5)
	350	+	business days".
	351	+	Page 6, line 38, delete "twenty-four (24)" and insert "forty-eight
	352	+	(48)".
	353	+	Page 6, line 40, delete "(d)" and insert "(e)".
	354	+	and when so amended that said bill do pass and be reassigned to the
	355	+	Senate Committee on Appropriations.
	356	+	(Reference is to SB 273 as introduced.)
	357	+	BALDWIN, Chairperson
	358	+	Committee Vote: Yeas 8, Nays 1.
	359	+	_____
	360	+	COMMITTEE REPORT
	361	+	Madam President: The Senate Committee on Appropriations, to
	362	+	which was referred Senate Bill No. 273, has had the same under
	363	+	consideration and begs leave to report the same back to the Senate with
	364	+	the recommendation that said bill be AMENDED as follows:
	365	+	Page 3, between lines 23 and 24, begin a new paragraph and insert:
	366	+	"(i) Before November 1, 2025, and before November 1 of each
99	367		year thereafter, the office of the secretary shall report to the
100	368		budget committee on the Medicaid reimbursement rates provided
	369	+	ES 273—LS 6648/DI 55 9
101	370		for biomarker testing. The report shall include the following
102	371		statewide aggregate information for the state fiscal year 2023 and
103	372		the state fiscal year most recently ended:
104	373		(1) The total number of patients who received biomarker
105	374		testing.
106	375		(2) The total number of patients who received biomarker
107	376		testing for each biomarker test type.
108	377		(3) The total amount of state funding expended for biomarker
109	378		testing.
110	379		(4) The ten (10) most common conditions or treatments for
111	380		which biomarker testing was ordered.
112	381		(5) As a result of the biomarker testing, how many patients:
113	382		(A) were placed on particular therapies;
114	383		(B) avoided certain treatments; and
115	384		(C) were subject to any other treatment impacts.
116	385		(6) Any other information requested by the budget committee.
117	386		Each provider that receives state Medicaid funding under this
118	387		section shall provide the information described in subdivisions (1)
119	388		through (6) to the office of the secretary not later than August 1 of
120		-	each year.
121		-	SECTION 2. IC 27-8-14.3 IS ADDED TO THE INDIANA CODE
122		-	SEA 273 4
123		-	AS A NEW CHAPTER TO READ AS FOLLOWS [EFFECTIVE
124		-	JULY 1, 2024]:
125		-	Chapter 14.3. Coverage for Biomarker Testing
126		-	Sec. 1. This chapter applies to:
127		-	(1) a policy of accident and sickness insurance or a health
128		-	maintenance organization contract that is issued, renewed, or
129		-	entered into after June 30, 2024;
130		-	(2) Medicaid managed care provided by a managed care
131		-	organization under a contract with the office of Medicaid
132		-	policy and planning that is entered into or renewed after June
133		-	30, 2024; and
134		-	(3) coverage provided by a state employee health plan after
135		-	June 30, 2024.
136		-	Sec. 2. (a) As used in this chapter, "accident and sickness
137		-	policy" means an insurance policy that provides at least one (1) of
138		-	the types of insurance described in IC 27-1-5-1, Classes 1(b) and
139		-	2(a).
140		-	(b) The term "accident and sickness policy" does not include the
141		-	following:
142		-	(1) Accident only, credit, dental, vision, Medicare supplement,
143		-	long term care, or disability income insurance.
144		-	(2) Coverage issued as a supplement to liability insurance.
145		-	(3) Worker's compensation or similar insurance.
146		-	(4) Automobile medical payment insurance.
147		-	(5) A specified disease policy.
148		-	(6) A short term insurance plan that:
149		-	(A) may be renewed for the greater of:
150		-	(i) thirty-six (36) months; or
151		-	(ii) the maximum period permitted under federal law;
152		-	(B) has a term of not more than three hundred sixty-four
153		-	(364) days; and
154		-	(C) has an annual limit of at least two million dollars
155		-	($2,000,000).
156		-	(7) A policy that provides indemnity benefits not based on any
157		-	expense incurred requirement, including a plan that provides
158		-	coverage for:
159		-	(A) hospital confinement, critical illness, or intensive care;
160		-	or
161		-	(B) gaps for deductibles or copayments.
162		-	(8) A supplemental plan that always pays in addition to other
163		-	coverage.
164		-	(9) A student health plan.
165		-	SEA 273 5
166		-	(10) An employer sponsored health benefit plan that is:
167		-	(A) provided to individuals who are eligible for Medicare;
168		-	and
169		-	(B) not marketed as, or held out to be, a Medicare
170		-	supplement policy.
171		-	Sec. 3. (a) As used in this chapter, "biomarker" means a
172		-	characteristic that is objectively measured and evaluated as an
173		-	indicator of:
174		-	(1) normal biological processes;
175		-	(2) pathogenic processes; or
176		-	(3) pharmacologic responses to a specific therapeutic
177		-	intervention, including known gene-drug interactions for
178		-	medications being considered for use or already being
179		-	administered.
180		-	(b) The term includes gene mutations, characteristics of genes,
181		-	and protein expression.
182		-	Sec. 4. (a) As used in this chapter, "biomarker testing" means
183		-	the analysis of a patient's tissue, blood, or other biospecimen for
184		-	the presence of a biomarker.
185		-	(b) The term includes:
186		-	(1) single-analyte tests;
187		-	(2) multiplex panel tests;
188		-	(3) protein expression; and
189		-	(4) whole exome, whole genome, and whole transcriptome
190		-	sequencing.
191		-	Sec. 5. As used in this chapter, "consensus statement" means a
192		-	statement that is:
193		-	(1) issued by an independent, multidisciplinary panel of
194		-	experts that:
195		-	(A) uses a transparent methodology and reporting
196		-	structure; and
197		-	(B) has a conflict of interest policy;
198		-	(2) aimed at specific clinical circumstances;
199		-	(3) based on the best available evidence; and
200		-	(4) developed for the purpose of optimizing the outcomes of
201		-	clinical care.
202		-	Sec. 6. As used in this chapter, "covered individual" means an
203		-	individual who is entitled to coverage under a health plan.
204		-	Sec. 7. (a) As used in this chapter, "health plan" means any of
205		-	the following:
206		-	(1) A policy of accident and sickness insurance.
207		-	(2) A contract with a health maintenance organization (as
208		-	SEA 273 6
209		-	defined in IC 27-13-1-19) that provides coverage for basic
210		-	health care services (as defined in IC 27-13-1-4).
211		-	(3) The Medicaid risk based managed care program operated
212		-	under IC 12-15.
213		-	(4) A state employee health plan.
214		-	(b) The term includes a person that administers a health plan.
215		-	Sec. 8. As used in this chapter, "nationally recognized clinical
216		-	practice guidelines" means evidence based clinical practice
217		-	guidelines that:
218		-	(1) are developed by an independent organization or medical
219		-	professional society that:
220		-	(A) uses a transparent methodology and reporting
221		-	structure; and
222		-	(B) has a conflict of interest policy;
223		-	(2) establish standards of care informed by:
224		-	(A) a systematic review of evidence; and
225		-	(B) an assessment of the benefits and risks of alternative
226		-	care options; and
227		-	(3) include recommendations intended to optimize patient
228		-	care.
229		-	Sec. 9. (a) As used in this chapter, "state employee health plan"
230		-	refers to either of the following:
231		-	(1) A self-insurance program established under
232		-	IC 5-10-8-7(b).
233		-	(2) A contract with a prepaid health care delivery plan that is
234		-	entered into or renewed under IC 5-10-8-7(c).
235		-	(b) The term includes a person that administers prescription
236		-	drug benefits on behalf of a state employee health plan.
237		-	Sec. 10. (a) A health plan shall provide coverage for biomarker
238		-	testing for the purposes of diagnosis, treatment, appropriate
239		-	management, or ongoing monitoring of an enrollee's disease or
240		-	condition when biomarker testing is supported by medical and
241		-	scientific evidence, including:
242		-	(1) labeled indications for a test approved or cleared by the
243		-	United States Food and Drug Administration;
244		-	(2) indicated tests for a drug approved by the United States
245		-	Food and Drug Administration;
246		-	(3) a warning or precaution on the label of a drug approved
247		-	by the United States Food and Drug Administration;
248		-	(4) a national coverage determination of the Centers for
249		-	Medicare and Medicaid Services (CMS);
250		-	(5) a local coverage determination of a Medicare
251		-	SEA 273 7
252		-	administrative contractor; or
253		-	(6) nationally recognized clinical practice guidelines or
254		-	consensus statements.
255		-	(b) The coverage required by this section must be provided in a
256		-	manner that limits disruptions in care, including the need for
257		-	multiple biopsies or biospecimen samples.
258		-	(c) Nothing in this section shall be construed to require coverage
259		-	of biomarker testing for screening purposes.
260		-	(d) If a prior authorization requirement applies to biomarker
261		-	testing under a health plan, the health plan or a third party acting
262		-	on behalf of the health plan must:
263		-	(1) approve or deny a request for prior authorization for
264		-	biomarker testing; and
265		-	(2) notify the covered individual and any person requesting
266		-	prior authorization of the biomarker testing on behalf of the
267		-	covered individual;
268		-	in not more than five (5) business days after the request in the case
269		-	of a nonurgent request or in not more than forty-eight (48) hours
270		-	after the request in the case of an urgent request.
271		-	(e) A health plan shall ensure that a covered individual and the
272		-	practitioner who prescribes biomarker testing for the covered
273		-	individual have access to a clear, readily accessible, and convenient
274		-	process for requesting an exception to:
275		-	(1) a coverage policy; or
276		-	(2) a prior authorization determination;
277		-	of the health plan that is adverse to the coverage of biomarker
278		-	testing for the covered individual. The process required by this
279		-	subsection shall be made readily accessible on the health plan's
280		-	website.
281		-	SEA 273 President of the Senate
282		-	President Pro Tempore
283		-	Speaker of the House of Representatives
284		-	Governor of the State of Indiana
285		-	Date: Time:
286		-	SEA 273
	389	+	each year.".
	390	+	and when so amended that said bill do pass.
	391	+	(Reference is to SB 273 as printed January 19, 2024.)
	392	+	MISHLER, Chairperson
	393	+	Committee Vote: Yeas 13, Nays 0.
	394	+	_____
	395	+	COMMITTEE REPORT
	396	+	Mr. Speaker: Your Committee on Insurance, to which was referred
	397	+	Senate Bill 273, has had the same under consideration and begs leave
	398	+	to report the same back to the House with the recommendation that said
	399	+	bill do pass.
	400	+	(Reference is to SB 273 as printed February 2, 2024.)
	401	+	CARBAUGH
	402	+	Committee Vote: Yeas 11, Nays 0
	403	+	ES 273—LS 6648/DI 55 10
	404	+	COMMITTEE REPORT
	405	+	Mr. Speaker: Your Committee on Ways and Means, to which was
	406	+	referred Engrossed Senate Bill 273, has had the same under
	407	+	consideration and begs leave to report the same back to the House with
	408	+	the recommendation that said bill do pass.
	409	+	(Reference is to ESB 273 as printed February 15, 2024.)
	410	+	THOMPSON
	411	+	Committee Vote: Yeas 19, Nays 0
	412	+	ES 273—LS 6648/DI 55