Massachusetts 2023-2024 Regular Session

Massachusetts Senate Bill S689 Compare Versions

Only one version of the bill is available at this time.

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1	1	1 of 1
2	2	SENATE DOCKET, NO. 1687 FILED ON: 1/19/2023
3	3	SENATE . . . . . . . . . . . . . . No. 689
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Susan L. Moran
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act relative to patient access to biomarker testing to provide appropriate therapy.
13	13	_______________
14	14	PETITION OF:
15	15	NAME:DISTRICT/ADDRESS :Susan L. MoranPlymouth and BarnstableJack Patrick Lewis7th Middlesex1/30/2023Michael O. MooreSecond Worcester2/2/2023William J. Driscoll, Jr.7th Norfolk2/6/2023John J. CroninWorcester and Middlesex2/8/2023John C. VelisHampden and Hampshire2/8/2023Jason M. LewisFifth Middlesex2/8/2023Patrick M. O'ConnorFirst Plymouth and Norfolk2/8/2023Joanne M. ComerfordHampshire, Franklin and Worcester2/10/2023Walter F. TimiltyNorfolk, Plymouth and Bristol2/10/2023Thomas M. Stanley9th Middlesex2/10/2023Anne M. GobiWorcester and Hampshire2/10/2023Michael D. BradySecond Plymouth and Norfolk2/10/2023Carmine Lawrence Gentile13th Middlesex2/15/2023Aaron L. Saunders7th Hampden2/28/2023 1 of 14
16	16	SENATE DOCKET, NO. 1687 FILED ON: 1/19/2023
17	17	SENATE . . . . . . . . . . . . . . No. 689
18	18	By Ms. Moran, a petition (accompanied by bill, Senate, No. 689) of Susan L. Moran, Jack
19	19	Patrick Lewis, Michael O. Moore, William J. Driscoll, Jr. and other members of the General
20	20	Court for legislation relative to patient access to biomarker testing to provide appropriate
21	21	therapy. Financial Services.
22	22	The Commonwealth of Massachusetts
23	23	_______________
24	24	In the One Hundred and Ninety-Third General Court
25	25	(2023-2024)
26	26	_______________
27	27	An Act relative to patient access to biomarker testing to provide appropriate therapy.
28	28	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
29	29	of the same, as follows:
30	30	1 SECTION 1. Chapter 32A of the General Laws is hereby amended by inserting after
31	31	2section 17R, the following section:-
32	32	3 Section 17S. (a) As used in this section, the following words shall have the following
33	33	4meanings:
34	34	5 “Biomarker” means a characteristic that is objectively measured and evaluated as an
35	35	6indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
36	36	7specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
37	37	8protein expression.
38	38	9 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
39	39	10the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
40	40	11multi-plex panel tests, and whole genome sequencing. 2 of 14
41	41	12 “Consensus statements” as used here are statements developed by an independent,
42	42	13multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
43	43	14and with a conflict of interest policy. These statements are aimed at specific clinical
44	44	15circumstances and base the statements on the best available evidence for the purpose of
45	45	16optimizing the outcomes of clinical care.
46	46	17 “Nationally recognized clinical practice guidelines” as used here are evidence-based
47	47	18clinical practice guidelines developed by independent organizations or medical professional
48	48	19societies utilizing a transparent methodology and reporting structure and with a conflict of
49	49	20interest policy. Clinical practice guidelines establish standards of care informed by a systematic
50	50	21review of evidence and an assessment of the benefits and costs of alternative care options and
51	51	22include recommendations intended to optimize patient care.
52	52	23 (b) The commission shall provide to any active or retired employee of the commonwealth
53	53	24who is insured under the group insurance commission coverage for biomarker testing as defined
54	54	25in this section, pursuant to criteria established under subsection (c).
55	55	26 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
56	56	27appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
57	57	28test is supported by medical and scientific evidence, including, but not limited to:
58	58	29 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
59	59	30FDA-approved drug;
60	60	31 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
61	61	32Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
62	62	33or 3 of 14
63	63	34 (3) Nationally recognized clinical practice guidelines and consensus statements.
64	64	35 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
65	65	36limits disruptions in care including the need for multiple biopsies or biospecimen samples.
66	66	37 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
67	67	38review organization subject to this section must approve or deny a prior authorization request or
68	68	39appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
69	69	40additional delay would result in significant risk to the insured’s health or well-being, a carrier or
70	70	41a utilization review organization shall approve or deny the request within 24 hours. If a response
71	71	42by a carrier or utilization review organization is not received within the time required under this
72	72	43paragraph, said request or appeal shall be deemed granted.
73	73	44 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
74	74	45and convenient processes to request an exception to a coverage policy or an adverse utilization
75	75	46review determination. The process shall be made readily accessible on the carrier’s website.
76	76	47 SECTION 2. Chapter 118E of the General Laws is hereby amended by inserting after
77	77	48section 10N, the following section:-
78	78	49 Section 10O. (a) As used in this section, the following words shall have the following
79	79	50meanings:
80	80	51 “Biomarker” means a characteristic that is objectively measured and evaluated as an
81	81	52indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
82	82	53specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
83	83	54protein expression. 4 of 14
84	84	55 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
85	85	56the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
86	86	57multi-plex panel tests, and whole genome sequencing.
87	87	58 “Consensus statements” as used here are statements developed by an independent,
88	88	59multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
89	89	60and with a conflict of interest policy. These statements are aimed at specific clinical
90	90	61circumstances and base the statements on the best available evidence for the purpose of
91	91	62optimizing the outcomes of clinical care.
92	92	63 “Nationally recognized clinical practice guidelines” as used here are evidence-based
93	93	64clinical practice guidelines developed by independent organizations or medical professional
94	94	65societies utilizing a transparent methodology and reporting structure and with a conflict of
95	95	66interest policy. Clinical practice guidelines establish standards of care informed by a systematic
96	96	67review of evidence and an assessment of the benefits and costs of alternative care options and
97	97	68include recommendations intended to optimize patient care.
98	98	69 (b) The division and its contracted health insurers, health plans, health maintenance
99	99	70organizations, behavioral health management firms and third-party administrators under contract
100	100	71to a Medicaid managed care organization or primary care clinician plan shall provide coverage
101	101	72for biomarker testing as defined in this section, pursuant to criteria established under subsection
102	102	73(c).
103	103	74 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
104	104	75appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
105	105	76test is supported by medical and scientific evidence, including, but not limited to: 5 of 14
106	106	77 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
107	107	78FDA-approved drug;
108	108	79 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
109	109	80Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
110	110	81or
111	111	82 (3) Nationally recognized clinical practice guidelines and consensus statements.
112	112	83 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
113	113	84limits disruptions in care including the need for multiple biopsies or biospecimen samples.
114	114	85 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
115	115	86review organization subject to this section must approve or deny a prior authorization request or
116	116	87appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
117	117	88additional delay would result in significant risk to the insured’s health or well-being, a carrier or
118	118	89a utilization review organization shall approve or deny the request within 24 hours. If a response
119	119	90by a carrier or utilization review organization is not received within the time required under this
120	120	91paragraph, said request or appeal shall be deemed granted.
121	121	92 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
122	122	93and convenient processes to request an exception to a coverage policy or an adverse utilization
123	123	94review determination. The process shall be made readily accessible on the carrier’s website.
124	124	95 SECTION 3. Chapter 175 of the General Laws is hereby amended by inserting after
125	125	96section 47PP, the following section:- 6 of 14
126	126	97 Section 47QQ. (a) As used in this section, the following words shall have the following
127	127	98meanings:
128	128	99 “Biomarker” means a characteristic that is objectively measured and evaluated as an
129	129	100indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
130	130	101specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
131	131	102protein expression.
132	132	103 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
133	133	104the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
134	134	105multi-plex panel tests, and whole genome sequencing.
135	135	106 “Consensus statements” as used here are statements developed by an independent,
136	136	107multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
137	137	108and with a conflict of interest policy. These statements are aimed at specific clinical
138	138	109circumstances and base the statements on the best available evidence for the purpose of
139	139	110optimizing the outcomes of clinical care.
140	140	111 “Nationally recognized clinical practice guidelines” as used here are evidence-based
141	141	112clinical practice guidelines developed by independent organizations or medical professional
142	142	113societies utilizing a transparent methodology and reporting structure and with a conflict of
143	143	114interest policy. Clinical practice guidelines establish standards of care informed by a systematic
144	144	115review of evidence and an assessment of the benefits and costs of alternative care options and
145	145	116include recommendations intended to optimize patient care.
146	146	117 (b) An individual policy of accident and sickness insurance issued under section 108 that
147	147	118provides benefits for hospital expenses and surgical expenses and any group blanket policy of 7 of 14
148	148	119accident and sickness insurance issued under section 110 that provides benefits for hospital
149	149	120expenses and surgical expenses delivered, issued or renewed by agreement between the insurer
150	150	121and the policyholder, within or outside the commonwealth, shall provide benefits for residents of
151	151	122the commonwealth and all group members having a principal place of employment in the
152	152	123commonwealth for biomarker testing as defined in this section, pursuant to criteria established
153	153	124under subsection (c).
154	154	125 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
155	155	126appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
156	156	127test is supported by medical and scientific evidence, including, but not limited to:
157	157	128 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
158	158	129FDA-approved drug;
159	159	130 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
160	160	131Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
161	161	132or
162	162	133 (3) Nationally recognized clinical practice guidelines and consensus statements.
163	163	134 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
164	164	135limits disruptions in care including the need for multiple biopsies or biospecimen samples.
165	165	136 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
166	166	137review organization subject to this section must approve or deny a prior authorization request or
167	167	138appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
168	168	139additional delay would result in significant risk to the insured’s health or well-being, a carrier or 8 of 14
169	169	140a utilization review organization shall approve or deny the request within 24 hours. If a response
170	170	141by a carrier or utilization review organization is not received within the time required under this
171	171	142paragraph, said request or appeal shall be deemed granted.
172	172	143 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
173	173	144and convenient processes to request an exception to a coverage policy or an adverse utilization
174	174	145review determination. The process shall be made readily accessible on the carrier’s website.
175	175	146 SECTION 4. Chapter 176A of the General Laws is hereby amended by inserting after
176	176	147section 8QQ, the following section:-
177	177	148 Section 8RR. (a) As used in this section, the following words shall have the following
178	178	149meanings:
179	179	150 “Biomarker” means a characteristic that is objectively measured and evaluated as an
180	180	151indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
181	181	152specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
182	182	153protein expression.
183	183	154 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
184	184	155the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
185	185	156multi-plex panel tests, and whole genome sequencing.
186	186	157 “Consensus statements” as used here are statements developed by an independent,
187	187	158multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
188	188	159and with a conflict of interest policy. These statements are aimed at specific clinical 9 of 14
189	189	160circumstances and base the statements on the best available evidence for the purpose of
190	190	161optimizing the outcomes of clinical care.
191	191	162 “Nationally recognized clinical practice guidelines” as used here are evidence-based
192	192	163clinical practice guidelines developed by independent organizations or medical professional
193	193	164societies utilizing a transparent methodology and reporting structure and with a conflict of
194	194	165interest policy. Clinical practice guidelines establish standards of care informed by a systematic
195	195	166review of evidence and an assessment of the benefits and costs of alternative care options and
196	196	167include recommendations intended to optimize patient care.
197	197	168 (b) Any contract between a subscriber and the corporation under an individual or group
198	198	169hospital service plan that is delivered, issued or renewed within the commonwealth shall provide
199	199	170coverage for biomarker testing as defined in this section, pursuant to criteria established under
200	200	171subsection (c).
201	201	172 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
202	202	173appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
203	203	174test is supported by medical and scientific evidence, including, but not limited to:
204	204	175 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
205	205	176FDA-approved drug;
206	206	177 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
207	207	178Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
208	208	179or
209	209	180 (3) Nationally recognized clinical practice guidelines and consensus statements. 10 of 14
210	210	181 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
211	211	182limits disruptions in care including the need for multiple biopsies or biospecimen samples.
212	212	183 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
213	213	184review organization subject to this section must approve or deny a prior authorization request or
214	214	185appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
215	215	186additional delay would result in significant risk to the insured’s health or well-being, a carrier or
216	216	187a utilization review organization shall approve or deny the request within 24 hours. If a response
217	217	188by a carrier or utilization review organization is not received within the time required under this
218	218	189paragraph, said request or appeal shall be deemed granted.
219	219	190 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
220	220	191and convenient processes to request an exception to a coverage policy or an adverse utilization
221	221	192review determination. The process shall be made readily accessible on the carrier’s website.
222	222	193 SECTION 5. Chapter 176B of the General Laws is hereby amended by inserting after
223	223	194section 4QQ, the following section:-
224	224	195 Section 4RR. (a) As used in this section, the following words shall have the following
225	225	196meanings:
226	226	197 “Biomarker” means a characteristic that is objectively measured and evaluated as an
227	227	198indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
228	228	199specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
229	229	200protein expression. 11 of 14
230	230	201 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
231	231	202the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
232	232	203multi-plex panel tests, and whole genome sequencing.
233	233	204 “Consensus statements” as used here are statements developed by an independent,
234	234	205multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
235	235	206and with a conflict of interest policy. These statements are aimed at specific clinical
236	236	207circumstances and base the statements on the best available evidence for the purpose of
237	237	208optimizing the outcomes of clinical care.
238	238	209 “Nationally recognized clinical practice guidelines” as used here are evidence-based
239	239	210clinical practice guidelines developed by independent organizations or medical professional
240	240	211societies utilizing a transparent methodology and reporting structure and with a conflict of
241	241	212interest policy. Clinical practice guidelines establish standards of care informed by a systematic
242	242	213review of evidence and an assessment of the benefits and costs of alternative care options and
243	243	214include recommendations intended to optimize patient care.
244	244	215 (b) Any subscription certificate under an individual or group medical service agreement
245	245	216delivered, issued or renewed within the commonwealth shall provide coverage for biomarker
246	246	217testing as defined in this section, pursuant to criteria established under subsection (c).
247	247	218 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
248	248	219appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
249	249	220test is supported by medical and scientific evidence, including, but not limited to:
250	250	221 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
251	251	222FDA-approved drug; 12 of 14
252	252	223 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
253	253	224Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
254	254	225or
255	255	226 (3) Nationally recognized clinical practice guidelines and consensus statements.
256	256	227 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
257	257	228limits disruptions in care including the need for multiple biopsies or biospecimen samples.
258	258	229 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
259	259	230review organization subject to this section must approve or deny a prior authorization request or
260	260	231appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
261	261	232additional delay would result in significant risk to the insured’s health or well-being, a carrier or
262	262	233a utilization review organization shall approve or deny the request within 24 hours. If a response
263	263	234by a carrier or utilization review organization is not received within the time required under this
264	264	235paragraph, said request or appeal shall be deemed granted.
265	265	236 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
266	266	237and convenient processes to request an exception to a coverage policy or an adverse utilization
267	267	238review determination. The process shall be made readily accessible on the carrier’s website.
268	268	239 SECTION 6. Chapter 176G of the General Laws is hereby amended by inserting after
269	269	240section 4GG, as so appearing, the following section:-
270	270	241 Section 4JJ. (a) As used in this section, the following words shall have the following
271	271	242meanings: 13 of 14
272	272	243 “Biomarker” means a characteristic that is objectively measured and evaluated as an
273	273	244indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
274	274	245specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
275	275	246protein expression.
276	276	247 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
277	277	248the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
278	278	249multi-plex panel tests, and whole genome sequencing.
279	279	250 “Consensus statements” as used here are statements developed by an independent,
280	280	251multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
281	281	252and with a conflict of interest policy. These statements are aimed at specific clinical
282	282	253circumstances and base the statements on the best available evidence for the purpose of
283	283	254optimizing the outcomes of clinical care.
284	284	255 “Nationally recognized clinical practice guidelines” as used here are evidence-based
285	285	256clinical practice guidelines developed by independent organizations or medical professional
286	286	257societies utilizing a transparent methodology and reporting structure and with a conflict of
287	287	258interest policy. Clinical practice guidelines establish standards of care informed by a systematic
288	288	259review of evidence and an assessment of the benefits and costs of alternative care options and
289	289	260include recommendations intended to optimize patient care.
290	290	261 (b) Any individual or group health maintenance contract that is issued or renewed within
291	291	262or without the commonwealth shall provide coverage for biomarker testing as defined in this
292	292	263section, pursuant to criteria established under subsection (c). 14 of 14
293	293	264 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
294	294	265appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
295	295	266test is supported by medical and scientific evidence, including, but not limited to:
296	296	267 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
297	297	268FDA-approved drug;
298	298	269 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
299	299	270Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
300	300	271or
301	301	272 (3) Nationally recognized clinical practice guidelines and consensus statements.
302	302	273 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
303	303	274limits disruptions in care including the need for multiple biopsies or biospecimen samples.
304	304	275 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
305	305	276review organization subject to this section must approve or deny a prior authorization request or
306	306	277appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
307	307	278additional delay would result in significant risk to the insured’s health or well-being, a carrier or
308	308	279a utilization review organization shall approve or deny the request within 24 hours. If a response
309	309	280by a carrier or utilization review organization is not received within the time required under this
310	310	281paragraph, said request or appeal shall be deemed granted.
311	311	282 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
312	312	283and convenient processes to request an exception to a coverage policy or an adverse utilization
313	313	284review determination. The process shall be made readily accessible on the carrier’s website.