Connecticut 2024 Regular Session

Connecticut Senate Bill SB00307 Compare Versions

Version 1 (Old)

Version 2 (New)

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	3	+	LCO 1 of 3
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4		-	Substitute Senate Bill No. 307
	5	+	General Assembly Substitute Bill No. 307
	6	+	February Session, 2024
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6		-	~~Public Act No. 24-50~~
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9	11		AN ACT CONCERNING MEDICAID COVERAGE OF BIOMARKER
10	12		TESTING.
11	13		Be it enacted by the Senate and House of Representatives in General
12	14		Assembly convened:
13	15
14		-	Section 1. (NEW) (Effective July 1, 2024) (a) As used in this section:
15		-	(1) "Biomarker" means a characteristic, including, but not limited to,
16		-	a gene mutation or protein expression that can be objectively measured
17		-	and evaluated as an indicator of normal biological processes, pathogenic
18		-	processes or pharmacologic responses to a specific therapeutic
19		-	intervention for a disease or condition.
20		-	(2) "Biomarker testing" means the analysis of a patient's tissue, blood
21		-	or other biospecimen for the presence of a biomarker, including, but not
22		-	limited to, tests for a single substance, tests for multiple substances,
23		-	diseases or conditions, and whole genome sequencing.
24		-	(3) "Clinical utility" means the test result provides information that is
25		-	used in the formulation of a treatment or monitoring strategy that
26		-	informs a patient's outcome and impacts the clinical decision. The most
27		-	appropriate test may include both information that is actionable and
28		-	some information that cannot be immediately used in the formulation
29		-	of a clinical decision. Substitute Senate Bill No. 307
	16	+	Section 1. (NEW) (Effective July 1, 2024) (a) As used in this section: 1
	17	+	(1) "Biomarker" means a characteristic, including, but not limited to, 2
	18	+	a gene mutation or protein expression that can be objectively measured 3
	19	+	and evaluated as an indicator of normal biological processes, pathogenic 4
	20	+	processes or pharmacologic responses to a specific therapeutic 5
	21	+	intervention for a disease or condition. 6
	22	+	(2) "Biomarker testing" means the analysis of a patient's tissue, blood 7
	23	+	or other biospecimen for the presence of a biomarker, including, but not 8
	24	+	limited to, tests for a single substance, tests for multiple substances, 9
	25	+	diseases or conditions, and whole genome sequencing. 10
	26	+	(3) "Consensus statements" means statements developed by an 11
	27	+	independent, multidisciplinary panel of experts utilizing a transparent 12
	28	+	methodology and reporting structure and with a conflict-of-interest 13
	29	+	policy that are (A) aimed at specific clinical circumstances, and (B) based 14
	30	+	on the best available evidence for the purpose of optimizing clinical care 15
	31	+	outcomes. 16
	32	+	(4) "Nationally recognized clinical practice guidelines" means 17 Substitute Bill No. 307
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31		-	Public Act No. 24-50 2 of 3
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33		-	(4) "Consensus statements" means statements developed by an
34		-	independent, multidisciplinary panel of experts utilizing a transparent
35		-	methodology and reporting structure and with a conflict-of-interest
36		-	policy that are (A) aimed at specific clinical circumstances, and (B) based
37		-	on the best available evidence for the purpose of optimizing clinical care
38		-	outcomes.
39		-	(5) "Nationally recognized clinical practice guidelines" means
40		-	evidence-based guidelines developed by independent organizations or
41		-	medical professional societies utilizing transparent methodologies and
42		-	reporting structures and conflict-of-interest policies that (A) establish
43		-	standards of care informed by a systematic review of evidence and
44		-	assessments of the benefits and costs of alternative care options, and (B)
45		-	include recommendations intended to optimize patient care.
46		-	(b) The Commissioner of Social Services, to the extent permissible
47		-	under federal law, shall provide coverage for biomarker testing for the
48		-	purpose of diagnosis, treatment, appropriate management or ongoing
49		-	monitoring of a Medicaid enrollee's disease or condition. The
50		-	commissioner shall ensure that such coverage is medically necessary
51		-	pursuant to section 17b-259b of the general statutes and, to assist in such
52		-	determination of medical necessity, shall analyze relevant information
53		-	and use applicable clinical guidelines to help inform such
54		-	determination, including medical and scientific evidence supporting
55		-	such test when the test provides clinical utility as demonstrated by
56		-	medical and scientific evidence, including, but not limited to, one or
57		-	more of the following: (1) Approval of such test by the federal Food and
58		-	Drug Administration or recommendations on labels of drugs approved
59		-	by the federal Food and Drug Administration to conduct such test, (2)
60		-	national coverage determinations or local coverage determinations for
61		-	Medicare Administrative Contractors by the Centers for Medicare and
62		-	Medicaid Services, or (3) nationally recognized clinical practice
63		-	guidelines and consensus statements. Nothing in this section shall Substitute Senate Bill No. 307
	35	+	LCO 2 of 3
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65		-	Public Act No. 24-50 3 of 3
	37	+	evidence-based guidelines developed by independent organizations or 18
	38	+	medical professional societies utilizing transparent methodologies and 19
	39	+	reporting structures and conflict-of-interest policies that (A) establish 20
	40	+	standards of care informed by a systematic review of evidence and 21
	41	+	assessments of the benefits and costs of alternative care options, and (B) 22
	42	+	include recommendations intended to optimize patient care. 23
	43	+	(b) The Commissioner of Social Services, to the extent permissible 24
	44	+	under federal law, shall provide coverage for biomarker testing for the 25
	45	+	purpose of diagnosis, treatment, appropriate management or ongoing 26
	46	+	monitoring of a Medicaid enrollee's disease or condition. The 27
	47	+	commissioner shall condition such coverage on medical and scientific 28
	48	+	evidence supporting such testing, including, but not limited to, (1) (A) 29
	49	+	approval of such testing by the federal Food and Drug Administration, 30
	50	+	or (B) recommendations provided on the labels of certain drugs 31
	51	+	approved by the federal Food and Drug Administration that such 32
	52	+	testing should be conducted prior to the use of such drugs, (2) national 33
	53	+	coverage determinations or local coverage determinations for Medicare 34
	54	+	Administrative Contractors by the Centers for Medicare and Medicaid 35
	55	+	Services, (3) nationally recognized clinical practice guidelines and 36
	56	+	consensus statements, or (4) any other sources for establishing medical 37
	57	+	necessity in accordance with section 17b-259b of the general statutes. 38
	58	+	(c) Nothing in this section shall be construed to limit the ability of the 39
	59	+	Department of Social Services to require prior authorization to ensure 40
	60	+	that a request for biomarker testing meets the standards under this 41
	61	+	section. 42
	62	+	This act shall take effect as follows and shall amend the following
	63	+	sections:
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67		-	change the requirement in section 17b-259b of the general statutes that
68		-	policies, guidelines and similar information shall be used solely as
69		-	guidelines and shall not be the basis for a final determination of medical
70		-	necessity.
71		-	(c) Nothing herein shall restrict the ability of the Department of Social
72		-	Services to require prior authorization to assure that a request for testing
73		-	meets the standards under this section.
74		-	(d) Any Medicaid enrollee who is adversely affected by a decision of
75		-	the department under this section may request a hearing in accordance
76		-	with section 17b-60 of the general statutes.
77		-	(e) The Commissioner of Social Services shall ensure that the
78		-	coverage as defined in subsection (b) of this section is provided in a
79		-	manner that is designed to limit disruptions in care.
	65	+	Section 1 July 1, 2024 New section
	66	+
	67	+	Statement of Legislative Commissioners:
	68	+	In Subsec. (b), "test" was changed to "testing" for consistency, Subsec.
	69	+	(b)(1) was redrafted for clarity, and in Subsec. (c), "testing" was changed
	70	+	to "biomarker testing" for consistency. Substitute Bill No. 307
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	73	+	LCO 3 of 3
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	75	+
	76	+	HS Joint Favorable Subst.
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