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HOUSE DOCKET, NO. 2413 FILED ON: 1/19/2023
HOUSE . . . . . . . . . . . . . . . No. 1074
The Commonwealth of Massachusetts
_________________
PRESENTED BY:
Meghan Kilcoyne
_________________
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 cancer patient access to biomarker testing to provide appropriate therapy.
_______________
PETITION OF:
NAME:DISTRICT/ADDRESS :DATE ADDED:Meghan Kilcoyne12th Worcester1/18/2023Lindsay N. Sabadosa1st Hampshire2/3/2023Paul J. Donato35th Middlesex2/3/2023Jack Patrick Lewis7th Middlesex2/3/2023Michael P. Kushmerek3rd Worcester2/3/2023Joseph W. McGonagle, Jr.28th Middlesex2/3/2023Kelly W. Pease4th Hampden2/3/2023Patricia A. Duffy5th Hampden2/3/2023Hannah Kane11th Worcester2/3/2023James C. Arena-DeRosa8th Middlesex2/21/2023Sean Garballey23rd Middlesex2/21/2023Daniel Cahill10th Essex2/21/2023Jessica Ann Giannino16th Suffolk2/21/2023William J. Driscoll, Jr.7th Norfolk2/21/2023Jon Santiago9th Suffolk2/21/2023Josh S. Cutler6th Plymouth2/21/2023John J. CroninWorcester and Middlesex2/21/2023Jason M. LewisFifth Middlesex2/21/2023 2 of 2
Danielle W. Gregoire4th Middlesex2/21/2023Daniel M. Donahue16th Worcester2/21/2023Adrian C. Madaro1st Suffolk2/21/2023Patrick M. O'ConnorFirst Plymouth and Norfolk2/21/2023Walter F. TimiltyNorfolk, Plymouth and Bristol2/21/2023Michael D. BradySecond Plymouth and Norfolk2/21/2023Thomas M. Stanley9th Middlesex2/21/2023Carole A. Fiola6th Bristol2/21/2023Patrick Joseph Kearney4th Plymouth2/21/2023David M. Rogers24th Middlesex2/21/2023Carmine Lawrence Gentile13th Middlesex2/21/2023Christine P. Barber34th Middlesex2/21/2023Michelle M. DuBois10th Plymouth2/21/2023Edward R. Philips8th Norfolk2/21/2023Aaron L. Saunders7th Hampden2/21/2023Rob Consalvo14th Suffolk2/21/2023Denise C. Garlick13th Norfolk2/21/2023James Arciero2nd Middlesex2/21/2023David Biele4th Suffolk3/1/2023Jonathan D. Zlotnik2nd Worcester3/1/2023Bruce J. Ayers1st Norfolk3/13/2023 1 of 14
HOUSE DOCKET, NO. 2413 FILED ON: 1/19/2023
HOUSE . . . . . . . . . . . . . . . No. 1074
By Representative Kilcoyne of Clinton, a petition (accompanied by bill, House, No. 1074) of
Meghan Kilcoyne and others relative to cancer patient access to biomarker testing to provide
appropriate therapy. Financial Services.
The Commonwealth of Massachusetts
_______________
In the One Hundred and Ninety-Third General Court
(2023-2024)
_______________
An Act relative to cancer 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 17R, the following section:-
3 Section 17S. (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. Biomarkers include but are not limited to gene mutations or
8protein expression.
9 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
10the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
11multi-plex panel tests, and whole genome sequencing. 2 of 14
12 “Consensus statements” as used here are statements developed by an independent,
13multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
14and with a conflict of interest policy. These statements are aimed at specific clinical
15circumstances and base the statements on the best available evidence for the purpose of
16optimizing the outcomes of clinical care.
17 “Nationally recognized clinical practice guidelines” as used here are evidence-based
18clinical practice guidelines developed by independent organizations or medical professional
19societies utilizing a transparent methodology and reporting structure and with a conflict of
20interest policy. Clinical practice guidelines establish standards of care informed by a systematic
21review of evidence and an assessment of the benefits and costs of alternative care options and
22include recommendations intended to optimize patient care.
23 (b) The commission shall provide to any active or retired employee of the commonwealth
24who is insured under the group insurance commission coverage for biomarker testing as defined
25in this section, pursuant to criteria established under subsection (c).
26 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
27appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
28test is supported by medical and scientific evidence, including, but not limited to:
29 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
30FDA-approved drug;
31 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
32Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
33or 3 of 14
34 (3) Nationally recognized clinical practice guidelines and consensus statements.
35 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
36limits disruptions in care including the need for multiple biopsies or biospecimen samples.
37 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
38review organization subject to this section must approve or deny a prior authorization request or
39appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
40additional delay would result in significant risk to the insured’s health or well-being, a carrier or
41a utilization review organization shall approve or deny the request within 24 hours. If a response
42by a carrier or utilization review organization is not received within the time required under this
43paragraph, said request or appeal shall be deemed granted.
44 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
45and convenient processes to request an exception to a coverage policy or an adverse utilization
46review determination. The process shall be made readily accessible on the carrier’s website.
47 SECTION 2. Chapter 118E of the General Laws is hereby amended by inserting after
48section 10N, the following section:-
49 Section 10O. (a) As used in this section, the following words shall have the following
50meanings:
51 “Biomarker” means a characteristic that is objectively measured and evaluated as an
52indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
53specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
54protein expression. 4 of 14
55 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
56the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
57multi-plex panel tests, and whole genome sequencing.
58 “Consensus statements” as used here are statements developed by an independent,
59multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
60and with a conflict of interest policy. These statements are aimed at specific clinical
61circumstances and base the statements on the best available evidence for the purpose of
62optimizing the outcomes of clinical care.
63 “Nationally recognized clinical practice guidelines” as used here are evidence-based
64clinical practice guidelines developed by independent organizations or medical professional
65societies utilizing a transparent methodology and reporting structure and with a conflict of
66interest policy. Clinical practice guidelines establish standards of care informed by a systematic
67review of evidence and an assessment of the benefits and costs of alternative care options and
68include recommendations intended to optimize patient care.
69 (b) The division and its contracted health insurers, health plans, health maintenance
70organizations, behavioral health management firms and third-party administrators under contract
71to a Medicaid managed care organization or primary care clinician plan shall provide coverage
72for biomarker testing as defined in this section, pursuant to criteria established under subsection
73(c).
74 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
75appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
76test is supported by medical and scientific evidence, including, but not limited to: 5 of 14
77 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
78FDA-approved drug;
79 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
80Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
81or
82 (3) Nationally recognized clinical practice guidelines and consensus statements.
83 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
84limits disruptions in care including the need for multiple biopsies or biospecimen samples.
85 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
86review organization subject to this section must approve or deny a prior authorization request or
87appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
88additional delay would result in significant risk to the insured’s health or well-being, a carrier or
89a utilization review organization shall approve or deny the request within 24 hours. If a response
90by a carrier or utilization review organization is not received within the time required under this
91paragraph, said request or appeal shall be deemed granted.
92 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
93and convenient processes to request an exception to a coverage policy or an adverse utilization
94review determination. The process shall be made readily accessible on the carrier’s website.
95 SECTION 3. Chapter 175 of the General Laws is hereby amended by inserting after
96section 47PP, the following section:- 6 of 14
97 Section 47QQ. (a) As used in this section, the following words shall have the following
98meanings:
99 “Biomarker” means a characteristic that is objectively measured and evaluated as an
100indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
101specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
102protein expression.
103 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
104the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
105multi-plex panel tests, and whole genome sequencing.
106 “Consensus statements” as used here are statements developed by an independent,
107multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
108and with a conflict of interest policy. These statements are aimed at specific clinical
109circumstances and base the statements on the best available evidence for the purpose of
110optimizing the outcomes of clinical care.
111 “Nationally recognized clinical practice guidelines” as used here are evidence-based
112clinical practice guidelines developed by independent organizations or medical professional
113societies utilizing a transparent methodology and reporting structure and with a conflict of
114interest policy. Clinical practice guidelines establish standards of care informed by a systematic
115review of evidence and an assessment of the benefits and costs of alternative care options and
116include recommendations intended to optimize patient care.
117 (b) An individual policy of accident and sickness insurance issued under section 108 that
118provides benefits for hospital expenses and surgical expenses and any group blanket policy of 7 of 14
119accident and sickness insurance issued under section 110 that provides benefits for hospital
120expenses and surgical expenses delivered, issued or renewed by agreement between the insurer
121and the policyholder, within or outside the commonwealth, shall provide benefits for residents of
122the commonwealth and all group members having a principal place of employment in the
123commonwealth for biomarker testing as defined in this section, pursuant to criteria established
124under subsection (c).
125 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
126appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
127test is supported by medical and scientific evidence, including, but not limited to:
128 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
129FDA-approved drug;
130 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
131Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
132or
133 (3) Nationally recognized clinical practice guidelines and consensus statements.
134 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
135limits disruptions in care including the need for multiple biopsies or biospecimen samples.
136 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
137review organization subject to this section must approve or deny a prior authorization request or
138appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
139additional delay would result in significant risk to the insured’s health or well-being, a carrier or 8 of 14
140a utilization review organization shall approve or deny the request within 24 hours. If a response
141by a carrier or utilization review organization is not received within the time required under this
142paragraph, said request or appeal shall be deemed granted.
143 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
144and convenient processes to request an exception to a coverage policy or an adverse utilization
145review determination. The process shall be made readily accessible on the carrier’s website.
146 SECTION 4. Chapter 176A of the General Laws is hereby amended by inserting after
147section 8QQ, the following section:-
148 Section 8RR. (a) As used in this section, the following words shall have the following
149meanings:
150 “Biomarker” means a characteristic that is objectively measured and evaluated as an
151indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
152specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
153protein expression.
154 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
155the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
156multi-plex panel tests, and whole genome sequencing.
157 “Consensus statements” as used here are statements developed by an independent,
158multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
159and with a conflict of interest policy. These statements are aimed at specific clinical 9 of 14
160circumstances and base the statements on the best available evidence for the purpose of
161optimizing the outcomes of clinical care.
162 “Nationally recognized clinical practice guidelines” as used here are evidence-based
163clinical practice guidelines developed by independent organizations or medical professional
164societies utilizing a transparent methodology and reporting structure and with a conflict of
165interest policy. Clinical practice guidelines establish standards of care informed by a systematic
166review of evidence and an assessment of the benefits and costs of alternative care options and
167include recommendations intended to optimize patient care.
168 (b) Any contract between a subscriber and the corporation under an individual or group
169hospital service plan that is delivered, issued or renewed within the commonwealth shall provide
170coverage for biomarker testing as defined in this section, pursuant to criteria established under
171subsection (c).
172 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
173appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
174test is supported by medical and scientific evidence, including, but not limited to:
175 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
176FDA-approved drug;
177 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
178Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
179or
180 (3) Nationally recognized clinical practice guidelines and consensus statements. 10 of 14
181 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
182limits disruptions in care including the need for multiple biopsies or biospecimen samples.
183 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
184review organization subject to this section must approve or deny a prior authorization request or
185appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
186additional delay would result in significant risk to the insured’s health or well-being, a carrier or
187a utilization review organization shall approve or deny the request within 24 hours. If a response
188by a carrier or utilization review organization is not received within the time required under this
189paragraph, said request or appeal shall be deemed granted.
190 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
191and convenient processes to request an exception to a coverage policy or an adverse utilization
192review determination. The process shall be made readily accessible on the carrier’s website.
193 SECTION 5. Chapter 176B of the General Laws is hereby amended by inserting after
194section 4QQ, the following section:-
195 Section 4RR. (a) As used in this section, the following words shall have the following
196meanings:
197 “Biomarker” means a characteristic that is objectively measured and evaluated as an
198indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
199specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
200protein expression. 11 of 14
201 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
202the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
203multi-plex panel tests, and whole genome sequencing.
204 “Consensus statements” as used here are statements developed by an independent,
205multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
206and with a conflict of interest policy. These statements are aimed at specific clinical
207circumstances and base the statements on the best available evidence for the purpose of
208optimizing the outcomes of clinical care.
209 “Nationally recognized clinical practice guidelines” as used here are evidence-based
210clinical practice guidelines developed by independent organizations or medical professional
211societies utilizing a transparent methodology and reporting structure and with a conflict of
212interest policy. Clinical practice guidelines establish standards of care informed by a systematic
213review of evidence and an assessment of the benefits and costs of alternative care options and
214include recommendations intended to optimize patient care.
215 (b) Any subscription certificate under an individual or group medical service agreement
216delivered, issued or renewed within the commonwealth shall provide coverage for biomarker
217testing as defined in this section, pursuant to criteria established under subsection (c).
218 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
219appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
220test is supported by medical and scientific evidence, including, but not limited to:
221 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
222FDA-approved drug; 12 of 14
223 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
224Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
225or
226 (3) Nationally recognized clinical practice guidelines and consensus statements.
227 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
228limits disruptions in care including the need for multiple biopsies or biospecimen samples.
229 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
230review organization subject to this section must approve or deny a prior authorization request or
231appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
232additional delay would result in significant risk to the insured’s health or well-being, a carrier or
233a utilization review organization shall approve or deny the request within 24 hours. If a response
234by a carrier or utilization review organization is not received within the time required under this
235paragraph, said request or appeal shall be deemed granted.
236 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
237and convenient processes to request an exception to a coverage policy or an adverse utilization
238review determination. The process shall be made readily accessible on the carrier’s website.
239 SECTION 6. Chapter 176G of the General Laws is hereby amended by inserting after
240section 4GG, as so appearing, the following section:-
241 Section 4JJ. (a) As used in this section, the following words shall have the following
242meanings: 13 of 14
243 “Biomarker” means a characteristic that is objectively measured and evaluated as an
244indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a
245specific therapeutic intervention. Biomarkers include but are not limited to gene mutations or
246protein expression.
247 “Biomarker testing” is the analysis of a patient’s tissue, blood, or other biospecimen for
248the presence of a biomarker. Biomarker testing includes but is not limited to single-analyte tests,
249multi-plex panel tests, and whole genome sequencing.
250 “Consensus statements” as used here are statements developed by an independent,
251multidisciplinary panel of experts utilizing a transparent methodology and reporting structure
252and with a conflict of interest policy. These statements are aimed at specific clinical
253circumstances and base the statements on the best available evidence for the purpose of
254optimizing the outcomes of clinical care.
255 “Nationally recognized clinical practice guidelines” as used here are evidence-based
256clinical practice guidelines developed by independent organizations or medical professional
257societies utilizing a transparent methodology and reporting structure and with a conflict of
258interest policy. Clinical practice guidelines establish standards of care informed by a systematic
259review of evidence and an assessment of the benefits and costs of alternative care options and
260include recommendations intended to optimize patient care.
261 (b) Any individual or group health maintenance contract that is issued or renewed within
262or without the commonwealth shall provide coverage for biomarker testing as defined in this
263section, pursuant to criteria established under subsection (c). 14 of 14
264 (c) Biomarker testing must be covered for the purposes of diagnosis, treatment,
265appropriate management, or ongoing monitoring of an enrollee’s disease or condition when the
266test is supported by medical and scientific evidence, including, but not limited to:
267 (1) Labeled indications for an FDA-approved or -cleared test or indicated tests for an
268FDA-approved drug;
269 (2) Centers for Medicare and Medicaid Services (CMS) National Coverage
270Determinations or Medicare Administrative Contractor (MAC) Local Coverage Determinations;
271or
272 (3) Nationally recognized clinical practice guidelines and consensus statements.
273 (d) coverage as defined in subsection (c) of this section shall be provided in a manner that
274limits disruptions in care including the need for multiple biopsies or biospecimen samples.
275 (e) In the case of coverage which requires prior authorization, a carrier or a utilization
276review organization subject to this section must approve or deny a prior authorization request or
277appeal and notify the enrollee and the enrollee’s health care provider within 72 hours. If
278additional delay would result in significant risk to the insured’s health or well-being, a carrier or
279a utilization review organization shall approve or deny the request within 24 hours. If a response
280by a carrier or utilization review organization is not received within the time required under this
281paragraph, said request or appeal shall be deemed granted.
282 (f) The patient and prescribing practitioner shall have access to a clear, readily accessible,
283and convenient processes to request an exception to a coverage policy or an adverse utilization
284review determination. The process shall be made readily accessible on the carrier’s website.