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SENATE DOCKET, NO. 532 FILED ON: 1/13/2025
SENATE . . . . . . . . . . . . . . No. 809
The Commonwealth of Massachusetts
_________________
PRESENTED BY:
Jacob R. Oliveira
_________________
To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
Court assembled:
The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
An Act relative to patient access to biomarker testing to provide appropriate therapy.
_______________
PETITION OF:
NAME:DISTRICT/ADDRESS :Jacob R. OliveiraHampden, Hampshire and WorcesterMichael O. MooreSecond Worcester2/4/2025Bradley H. Jones, Jr.20th Middlesex2/4/2025Thomas M. Stanley9th Middlesex2/4/2025Michael D. BradySecond Plymouth and Norfolk2/6/2025Barry R. FinegoldSecond Essex and Middlesex2/12/2025Angelo J. Puppolo, Jr.12th Hampden2/13/2025Joanne M. ComerfordHampshire, Franklin and Worcester2/14/2025John F. KeenanNorfolk and Plymouth2/24/2025Paul K. Frost7th Worcester2/25/2025Bruce E. TarrFirst Essex and Middlesex2/26/2025John C. VelisHampden and Hampshire2/27/2025Brendan P. CrightonThird Essex3/3/2025Patrick M. O'ConnorFirst Plymouth and Norfolk3/3/2025Ryan C. FattmanWorcester and Hampden3/5/2025Jason M. LewisFifth Middlesex3/6/2025Sal N. DiDomenicoMiddlesex and Suffolk3/7/2025William J. Driscoll, Jr.Norfolk, Plymouth and Bristol3/7/2025 1 of 16
SENATE DOCKET, NO. 532 FILED ON: 1/13/2025
SENATE . . . . . . . . . . . . . . No. 809
By Mr. Oliveira, a petition (accompanied by bill, Senate, No. 809) of Jacob R. Oliveira, Michael
O. Moore, Bradley H. Jones, Jr., Thomas M. Stanley and other members of the General Court for
legislation relative to patient access to biomarker testing to provide appropriate therapy.
Financial Services.
[SIMILAR MATTER FILED IN PREVIOUS SESSION
SEE SENATE, NO. 689 OF 2023-2024.]
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Fourth General Court
(2025-2026)
_______________
An Act relative to patient access to biomarker testing to provide appropriate therapy.
Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
of the same, as follows:
1 SECTION 1. Chapter 32A of the General Laws is hereby amended by inserting after
2section 17Q, the following section:-
3 Section 17R. (a) As used in this section, the following words shall have the following
4meanings:
5 “Biomarker” means a characteristic that is objectively measured and evaluated as an
6indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
7specific therapeutic intervention, including known gene-drug interactions for medications being
8considered for use or already being administered. Biomarkers include but are not limited to gene
9mutations, characteristics of genes or protein expression. 2 of 16
10 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
11the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
12multi-plex panel tests, protein expression, and whole exome, whole genome, and whole
13transcriptome sequencing.
14 “Consensus statements” as used here are statements developed by an independent,
15multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
16and with a conflict of interest policy. These statements are aimed at specific clinical
17circumstances and base the statements on the best available evidence for the purpose of
18optimizing the outcomes of clinical care.
19 “Nationally recognized clinical practice guidelines” as used here are evidence-based
20clinical practice guidelines developed by independent organizations or medical professional
21societies utilizing a transparent methodology and reporting structure and with a conflict of
22interest policy. Clinical practice guidelines establish standards of care informed by a systematic
23review of evidence and an assessment of the benefits and risks of alternative care options and
24include recommendations intended to optimize patient care.
25 (b) The commission shall provide to any active or retired employee of the commonwealth
26who is insured under the group insurance commission coverage for biomarker testing as defined
27in this section, pursuant to criteria established under subsection (c).
28 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
29appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
30test is supported by medical and scientific evidence, including, but not limited to:
31 1. Labeled indications for an FDA-approved or -cleared test; 3 of 16
32 2. Indicated tests for an FDA-approved drug;
33 3. Warnings and precautions on FDA-approved drug labels;
34 4. Centers for Medicare and Medicaid Services (CMS) National Coverage
35Determinations or any Medicare Administrative Contractor (MAC) Local Coverage
36Determinations; or
37 5. Nationally recognized clinical practice guidelines and consensus statements.
38 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
39limits disruptions in care including the need for multiple biopsies or biospecimen samples.
40 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
41review organization subject to this section must approve or deny a prior authorization request or
42appeal and notify the enrollee, the enrollee’s health care provider and any entity requesting
43authorization of the service within 72 hours. If additional delay would result in significant risk
44to the insured’s health or well-being, a carrier or a utilization review organization shall approve
45or deny the request within 24 hours. If a response by a carrier or utilization review organization
46is not received within the time required under this paragraph, said request or appeal shall be
47deemed granted.
48 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
49and convenient processes to request an exception to a coverage policy or an adverse utilization
50review determination. The process shall be made readily accessible on the carrier’s website.
51 SECTION 2. Chapter 118E of the General Laws is hereby amended by inserting after
52section 10L, the following section:- 4 of 16
53 Section 10M. (a) As used in this section, the following words shall have the following
54meanings:
55 “Biomarker” means a characteristic that is objectively measured and evaluated as an
56indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
57specific therapeutic intervention, including known gene-drug interactions for medications being
58considered for use or already being administered. Biomarkers include but are not limited to gene
59mutations, characteristics of genes or protein expression.
60 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
61the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
62multi-plex panel tests, protein expression, and whole exome, whole genome, and whole
63transcriptome sequencing.
64 “Consensus statements” as used here are statements developed by an independent,
65multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
66and with a conflict of interest policy. These statements are aimed at specific clinical
67circumstances and base the statements on the best available evidence for the purpose of
68optimizing the outcomes of clinical care.
69 “Nationally recognized clinical practice guidelines” as used here are evidence-based
70clinical practice guidelines developed by independent organizations or medical professional
71societies utilizing a transparent methodology and reporting structure and with a conflict of
72interest policy. Clinical practice guidelines establish standards of care informed by a systematic
73review of evidence and an assessment of the benefits and risks of alternative care options and
74include recommendations intended to optimize patient care. 5 of 16
75 (b) The division and its contracted health insurers, health plans, health maintenance
76organizations, behavioral health management firms and third-party administrators under contract
77to a Medicaid managed care organization or primary care clinician plan shall provide coverage
78for biomarker testing as defined in this section, pursuant to criteria established under subsection
79(c).
80 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
81appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
82test is supported by medical and scientific evidence, including, but not limited to:
83 1. Labeled indications for an FDA-approved or -cleared test
84 2. Indicated tests for an FDA-approved drug;
85 3. Warnings and precautions on FDA-approved drug labels;
86 4. Centers for Medicare and Medicaid Services (CMS) National Coverage
87Determinations or any Medicare Administrative Contractor (MAC) Local Coverage
88Determinations; or
89 5. Nationally recognized clinical practice guidelines and consensus statements.
90 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
91limits disruptions in care including the need for multiple biopsies or biospecimen samples.
92 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
93review organization subject to this section must approve or deny a prior authorization request or
94appeal and notify the enrollee, the enrollee’s health care provider and any entity requesting
95authorization of the service within 72 hours. If additional delay would result in significant risk 6 of 16
96to the insured’s health or well-being, a carrier or a utilization review organization shall approve
97or deny the request within 24 hours. If a response by a carrier or utilization review organization
98is not received within the time required under this paragraph, said request or appeal shall be
99deemed granted.
100 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
101and convenient processes to request an exception to a coverage policy or an adverse utilization
102review determination. The process shall be made readily accessible on the carrier’s website.
103 SECTION 3. Chapter 175 of the General Laws is hereby amended by inserting after
104section 47KK, the following section:-
105 Section 47LL. (a) As used in this section, the following words shall have the following
106meanings:
107 “Biomarker” means a characteristic that is objectively measured and evaluated as an
108indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
109specific therapeutic intervention, including known gene-drug interactions for medications being
110considered for use or already being administered. Biomarkers include but are not limited to gene
111mutations, characteristics of genes or protein expression.
112 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
113the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
114multi-plex panel tests, protein expression, and whole exome, whole genome, and whole
115transcriptome sequencing. 7 of 16
116 “Consensus statements” as used here are statements developed by an independent,
117multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
118and with a conflict of interest policy. These statements are aimed at specific clinical
119circumstances and base the statements on the best available evidence for the purpose of
120optimizing the outcomes of clinical care.
121 “Nationally recognized clinical practice guidelines” as used here are evidence-based
122clinical practice guidelines developed by independent organizations or medical professional
123societies utilizing a transparent methodology and reporting structure and with a conflict of
124interest policy. Clinical practice guidelines establish standards of care informed by a systematic
125review of evidence and an assessment of the benefits and risks of alternative care options and
126include recommendations intended to optimize patient care.
127 (b) An individual policy of accident and sickness insurance issued under section 108 that
128provides benefits for hospital expenses and surgical expenses and any group blanket policy of
129accident and sickness insurance issued under section 110 that provides benefits for hospital
130expenses and surgical expenses delivered, issued or renewed by agreement between the insurer
131and the policyholder, within or outside the commonwealth, shall provide benefits for residents of
132the commonwealth and all group members having a principal place of employment in the
133commonwealth for biomarker testing as defined in this section, pursuant to criteria established
134under subsection (c).
135 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
136appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
137test is supported by medical and scientific evidence, including, but not limited to: 8 of 16
138 1. Labeled indications for an FDA-approved or -cleared test
139 2. Indicated tests for an FDA-approved drug;
140 3. Warnings and precautions on FDA-approved drug labels;
141 4. Centers for Medicare and Medicaid Services (CMS) National Coverage
142Determinations or any Medicare Administrative Contractor (MAC) Local Coverage
143Determinations; or
144 5. Nationally recognized clinical practice guidelines and consensus statements.
145 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
146limits disruptions in care including the need for multiple biopsies or biospecimen samples.
147 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
148review organization subject to this section must approve or deny a prior authorization request or
149appeal and notify the enrollee, the enrollee’s health care provider and any entity requesting
150authorization of the service within 72 hours. If additional delay would result in significant risk
151to the insured’s health or well-being, a carrier or a utilization review organization shall approve
152or deny the request within 24 hours. If a response by a carrier or utilization review organization
153is not received within the time required under this paragraph, said request or appeal shall be
154deemed granted.
155 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
156and convenient processes to request an exception to a coverage policy or an adverse utilization
157review determination. The process shall be made readily accessible on the carrier’s website. 9 of 16
158 SECTION 4. Chapter 176A of the General Laws is hereby amended by inserting after
159section 8MM, the following section:-
160 Section 8NN. (a) As used in this section, the following words shall have the following
161meanings:
162 “Biomarker” means a characteristic that is objectively measured and evaluated as an
163indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
164specific therapeutic intervention, including known gene-drug interactions for medications being
165considered for use or already being administered. Biomarkers include but are not limited to gene
166mutations, characteristics of genes or protein expression.
167 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
168the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
169multi-plex panel tests, protein expression, and whole exome, whole genome, and whole
170transcriptome, sequencing.
171 “Consensus statements” as used here are statements developed by an independent,
172multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
173and with a conflict of interest policy. These statements are aimed at specific clinical
174circumstances and base the statements on the best available evidence for the purpose of
175optimizing the outcomes of clinical care.
176 “Nationally recognized clinical practice guidelines” as used here are evidence-based
177clinical practice guidelines developed by independent organizations or medical professional
178societies utilizing a transparent methodology and reporting structure and with a conflict of
179interest policy. Clinical practice guidelines establish standards of care informed by a systematic 10 of 16
180review of evidence and an assessment of the benefits and risks of alternative care options and
181include recommendations intended to optimize patient care.
182 (b) Any contract between a subscriber and the corporation under an individual or group
183hospital service plan that is delivered, issued or renewed within the commonwealth shall provide
184coverage for biomarker testing as defined in this section, pursuant to criteria established under
185subsection (c).
186 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
187appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
188test is supported by medical and scientific evidence, including, but not limited to:
189 1. Labeled indications for an FDA-approved or -cleared test
190 2. Indicated tests for an FDA-approved drug;
191 3. Warnings and precautions on FDA-approved drug labels;
192 4. Centers for Medicare and Medicaid Services (CMS) National Coverage
193Determinations or any Medicare Administrative Contractor (MAC) Local Coverage
194Determinations; or
195 5. Nationally recognized clinical practice guidelines and consensus statements.
196 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
197limits disruptions in care including the need for multiple biopsies or biospecimen samples.
198 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
199review organization subject to this section must approve or deny a prior authorization request or 11 of 16
200appeal and notify the enrollee, the enrollee’s health care provider and any entity requesting
201authorization of the service within 72 hours. If additional delay would result in significant risk
202to the insured’s health or well-being, a carrier or a utilization review organization shall approve
203or deny the request within 24 hours. If a response by a carrier or utilization review organization
204is not received within the time required under this paragraph, said request or appeal shall be
205deemed granted.
206 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
207and convenient processes to request an exception to a coverage policy or an adverse utilization
208review determination. The process shall be made readily accessible on the carrier’s website.
209 SECTION 5. Chapter 176B of the General Laws is hereby amended by inserting after
210section 4MM, the following section:-
211 Section 4NN. (a) As used in this section, the following words shall have the following
212meanings:
213 “Biomarker” means a characteristic that is objectively measured and evaluated as an
214indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
215specific therapeutic intervention, including known gene-drug interactions for medications being
216considered for use or already being administered. Biomarkers include but are not limited to gene
217mutations, characteristics of genes or protein expression.
218 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
219the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
220multi-plex panel tests, protein expression, and whole exome, whole genome, and whole
221transcriptome sequencing. 12 of 16
222 “Consensus statements” as used here are statements developed by an independent,
223multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
224and with a conflict of interest policy. These statements are aimed at specific clinical
225circumstances and base the statements on the best available evidence for the purpose of
226optimizing the outcomes of clinical care.
227 “Nationally recognized clinical practice guidelines” as used here are evidence-based
228clinical practice guidelines developed by independent organizations or medical professional
229societies utilizing a transparent methodology and reporting structure and with a conflict of
230interest policy. Clinical practice guidelines establish standards of care informed by a systematic
231review of evidence and an assessment of the benefits and risks of alternative care options and
232include recommendations intended to optimize patient care.
233 (b) Any subscription certificate under an individual or group medical service agreement
234delivered, issued or renewed within the commonwealth shall provide coverage for biomarker
235testing as defined in this section, pursuant to criteria established under subsection (c).
236 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
237appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
238test is supported by medical and scientific evidence, including, but not limited to:
239 1. Labeled indications for an FDA-approved or -cleared test
240 2. Indicated tests for an FDA-approved drug;
241 3. Warnings and precautions on FDA-approved drug labels; 13 of 16
242 4. Centers for Medicare and Medicaid Services (CMS) National Coverage
243Determinations or any Medicare Administrative Contractor (MAC) Local Coverage
244Determinations; or
245 5. Nationally recognized clinical practice guidelines and consensus statements.
246 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
247limits disruptions in care including the need for multiple biopsies or biospecimen samples.
248 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
249review organization subject to this section must approve or deny a prior authorization request or
250appeal and notify the enrollee, the enrollee’s health care provider and any entity requesting
251authorization of the service within 72 hours. If additional delay would result in significant risk
252to the insured’s health or well-being, a carrier or a utilization review organization shall approve
253or deny the request within 24 hours. If a response by a carrier or utilization review organization
254is not received within the time required under this paragraph, said request or appeal shall be
255deemed granted.
256 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
257and convenient processes to request an exception to a coverage policy or an adverse utilization
258review determination. The process shall be made readily accessible on the carrier’s website.
259 SECTION 6. Chapter 176G of the General Laws is hereby amended by inserting after
260section 4EE, as so appearing, the following section:-
261 Section 4FF. (a) As used in this section, the following words shall have the following
262meanings: 14 of 16
263 “Biomarker” means a characteristic that is objectively measured and evaluated as an
264indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
265specific therapeutic intervention, including known gene-drug interactions for medications being
266considered for use or already being administered. Biomarkers include but are not limited to gene
267mutations, characteristics of genes or protein expression.
268 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
269the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
270multi-plex panel tests, protein expression, and whole exome, whole genome, and whole
271transcriptome sequencing.
272 “Consensus statements” as used here are statements developed by an independent,
273multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
274and with a conflict of interest policy. These statements are aimed at specific clinical
275circumstances and base the statements on the best available evidence for the purpose of
276optimizing the outcomes of clinical care.
277 “Nationally recognized clinical practice guidelines” as used here are evidence-based
278clinical practice guidelines developed by independent organizations or medical professional
279societies utilizing a transparent methodology and reporting structure and with a conflict of
280interest policy. Clinical practice guidelines establish standards of care informed by a systematic
281review of evidence and an assessment of the benefits and risks of alternative care options and
282include recommendations intended to optimize patient care. 15 of 16
283 (b) Any individual or group health maintenance contract that is issued or renewed within
284or without the commonwealth shall provide coverage for biomarker testing as defined in this
285section, pursuant to criteria established under subsection (c).
286 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
287appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
288test is supported by medical and scientific evidence, including, but not limited to:
289 1. Labeled indications for an FDA-approved or -cleared test
290 2. Indicated tests for an FDA-approved drug;
291 3. Warnings and precautions on FDA-approved drug labels;
292 4. Centers for Medicare and Medicaid Services (CMS) National Coverage
293Determinations or any Medicare Administrative Contractor (MAC) Local Coverage
294Determinations; or
295 5. Nationally recognized clinical practice guidelines and consensus statements.
296 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
297limits disruptions in care including the need for multiple biopsies or biospecimen samples.
298 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
299review organization subject to this section must approve or deny a prior authorization request or
300appeal and notify the enrollee, the enrollee’s health care provider and any entity requesting
301authorization of the service within 72 hours. If additional delay would result in significant risk
302to the insured’s health or well-being, a carrier or a utilization review organization shall approve
303or deny the request within 24 hours. If a response by a carrier or utilization review organization 16 of 16
304is not received within the time required under this paragraph, said request or appeal shall be
305deemed granted.
306 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
307and convenient processes to request an exception to a coverage policy or an adverse utilization
308review determination. The process shall be made readily accessible on the carrier’s website.