Massachusetts 2023-2024 Regular Session

Massachusetts Senate Bill S2520 Compare Versions

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1	1	SENATE . . . . . . . . . . . . . . No. 2520
2	2	The Commonwealth of Massachusetts
3	3	_______________
4	4	In the One Hundred and Ninety-Second General Court
5	5	(2021-2022)
6	6	_______________
7	7	SENATE, November 15, 2023.
8	8	The committee on Senate Bills in the Third Reading to whom was referred the Senate
9	9	Bill relative to pharmaceutical access, costs and transparency (Senate, No. 2499, amended);
10	10	reports, recommending that the same be amended as follows, and that, when so amended, it will
11	11	be correctly drawn:-- by substituting a new with the same title (Senate, No. 2520).
12	12	For the committee,
13	13	Sal N. DiDomenico 1 of 100
14	14	FILED ON: 11/15/2023
15	15	SENATE . . . . . . . . . . . . . . No. 2520
16	16	The Commonwealth of Massachusetts
17	17	_______________
18	18	In the One Hundred and Ninety-Third General Court
19	19	(2023-2024)
20	20	_______________
21	21	An Act relative to pharmaceutical access, costs and transparency.
22	22	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
23	23	of the same, as follows:
24	24	1 SECTION 1. Section 1 of chapter 6D of the General Laws, as appearing in the 2022
25	25	2Official Edition, is hereby amended by inserting after the definition of “Alternative payment
26	26	3methodologies or methods” the following 2 definitions:-
27	27	4 “Biosimilar”, a drug that is produced or distributed under a biologics license application
28	28	5approved under 42 U.S.C. 262(k)(3).
29	29	6 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
30	30	7drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
31	31	8application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
32	32	9is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
33	33	10Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
34	34	11application that was approved by the United States Secretary of Health and Human Services
35	35	12under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
36	36	13date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 2 of 100
37	37	141984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
38	38	15C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
39	39	16under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the carrier as a brand name drug based on
40	40	17available data resources such as Medi-Span.
41	41	18 SECTION 2. Said section 1 of said chapter 6D, as so appearing, is hereby further
42	42	19amended by inserting after the definition of “Disproportionate share hospital” the following
43	43	20definition:-
44	44	21 “Early notice”, advanced notification by a pharmaceutical manufacturing company of a:
45	45	22(i) new drug, device or other product coming to market; or (ii) a price increase, as described in
46	46	23subsection (b) of section 15A.
47	47	24 SECTION 3. Said section 1 of said chapter 6D, as so appearing, is hereby further
48	48	25amended by inserting after the definition of “Fiscal year” the following definition:-
49	49	26 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
50	50	27abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
51	51	28drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
52	52	29and was not originally marketed under a new drug application; or (iv) identified by the carrier as
53	53	30a generic drug based on available data resources such as Medi-Span.
54	54	31 SECTION 4. Said section 1 of said chapter 6D, as so appearing, is hereby further
55	55	32amended by striking out, in line 189, the words “not include excludes ERISA plans” and
56	56	33inserting in place thereof the following words:- include self-insured plans to the extent allowed
57	57	34under the federal Employee Retirement Income Security Act of 1974. 3 of 100
58	58	35 SECTION 5. Said section 1 of said chapter 6D, as so appearing, is hereby further
59	59	36amended by inserting after the definition of “Performance penalty” the following 2 definitions:-
60	60	37 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
61	61	38preparation, propagation, compounding, conversion or processing of prescription drugs, directly
62	62	39or indirectly, by extraction from substances of natural origin, independently by means of
63	63	40chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
64	64	41repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
65	65	42“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed
66	66	43under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
67	67	44chapter 112.
68	68	45 “Pharmacy benefit manager”, a person, business or other entity, however organized, that
69	69	46directly or through a subsidiary provides pharmacy benefit management services for prescription
70	70	47drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
71	71	48insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
72	72	49management services shall include, but not be limited to: (i) the processing and payment of
73	73	50claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing
74	74	51of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or
75	75	52grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii)
76	76	53drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x)
77	77	54clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of
78	78	55covered prescription drugs; provided further, that “pharmacy benefit manager” shall include a
79	79	56health benefit plan sponsor that does not contract with a pharmacy benefit manager and manages
80	80	57its own prescription drug benefits unless specifically exempted by the commission. 4 of 100
81	81	58 SECTION 6. Said section 1 of said chapter 6D, as so appearing, is hereby further
82	82	59amended by inserting after the definition of “Physician” the following definition:-
83	83	60 “Pipeline drug”, a prescription drug product containing a new molecular entity for which
84	84	61the sponsor has submitted a new drug application or biologics license application and received an
85	85	62action date from the United States Food and Drug Administration.
86	86	63 SECTION 7. Said section 1 of said chapter 6D, as so appearing, is hereby further
87	87	64amended by adding the following definition:-
88	88	65 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C.
89	89	661395w-3a(c)(6)(B).
90	90	67 SECTION 8. Said chapter 6D is hereby further amended by striking out section 2A, as so
91	91	68appearing, and inserting in place thereof the following section:-
92	92	69 Section 2A. The commission shall keep confidential all nonpublic clinical, financial,
93	93	70strategic or operational documents or information provided or reported to the commission in
94	94	71connection with any care delivery, quality improvement process, performance improvement
95	95	72plan, early notification or access and affordability improvement plan activities authorized under
96	96	73sections 7, 10, 14, 15, 15A, 20 or 21 of this chapter or under section 2GGGG of chapter 29 and
97	97	74shall not disclose the information or documents to any person without the consent of the entity
98	98	75providing or reporting the information or documents under said sections 7, 10, 14, 15, 15A, 20 or
99	99	7621 of this chapter or under said section 2GGGG of said chapter 29, except in summary form in
100	100	77evaluative reports of such activities or when the commission believes that such disclosure should
101	101	78be made in the public interest after taking into account any privacy, trade secret or
102	102	79anticompetitive considerations. The confidential information and documents shall not be public 5 of 100
103	103	80records and shall be exempt from disclosure under clause Twenty-sixth of section 7 of chapter 4
104	104	81or under chapter 66.
105	105	82 SECTION 9. Section 4 of said chapter 6D, as so appearing, is hereby amended by
106	106	83striking out, in line 8, the word “manufacturers” and inserting in place thereof the following
107	107	84words:- manufacturing companies, pharmacy benefit managers.
108	108	85 SECTION 10. Section 6 of said chapter 6D, as so appearing, is hereby amended by
109	109	86inserting after the word “center”, in line 1, the following words:- , pharmaceutical and
110	110	87biopharmaceutical manufacturing company, pharmacy benefit manager.
111	111	88 SECTION 11. Said section 6 of said chapter 6D, as so appearing, is hereby further
112	112	89amended by striking out, in lines 5 and 36, the figure “33” and inserting in place thereof, in each
113	113	90instance, the following figure:- 25.
114	114	91 SECTION 12. Said section 6 of said chapter 6D, as so appearing, is hereby further
115	115	92amended by adding the following paragraph:-
116	116	93 The assessed amount for pharmaceutical and biopharmaceutical manufacturing
117	117	94companies and pharmacy benefit managers shall be not less than 25 per cent of the amount
118	118	95appropriated by the general court for the expenses of the commission minus amounts collected
119	119	96from: (i) filing fees; (ii) fees and charges generated by the commission's publication or
120	120	97dissemination of reports and information; and (iii) federal matching revenues received for these
121	121	98expenses or received retroactively for expenses of predecessor agencies. A pharmacy benefit
122	122	99manager that is a surcharge payor subject to the preceding paragraph and manages its own
123	123	100prescription drug benefits shall not be subject to additional assessment under this paragraph. 6 of 100
124	124	101 SECTION 13. Section 8 of said chapter 6D, as so appearing, is hereby amended by
125	125	102inserting after the word “organization”, in lines 6 and 7, the following words:- , pharmacy benefit
126	126	103manager, pharmaceutical manufacturing company.
127	127	104 SECTION 14. Said section 8 of said chapter 6D, as so appearing, is hereby further
128	128	105amended by inserting after the word “organizations”, in line 15, the following words:- ,
129	129	106pharmacy benefit managers, pharmaceutical manufacturing companies.
130	130	107 SECTION 15. Said section 8 of said chapter 6D, as so appearing, is hereby further
131	131	108amended by striking out, in line 33, the words “and (xi)” and inserting in place thereof the
132	132	109following words:- (xi) not less than 3 representatives of the pharmaceutical industry; (xii) at least
133	133	1101 representative of the pharmacy benefit management industry; and (xiii).
134	134	111 SECTION 16. Said section 8 of said chapter 6D, as so appearing, is hereby further
135	135	112amended by striking out, in line 49, the first time it appears, the word:- and.
136	136	113 SECTION 17. Said section 8 of said chapter 6D, as so appearing, is hereby further
137	137	114amended by inserting after the word “commission”, in line 60, the first time it appears, the
138	138	115following words:- ; and (iii) in the case of pharmacy benefit managers and pharmaceutical
139	139	116manufacturing companies, testimony concerning factors underlying prescription drug costs and
140	140	117price changes including, but not limited to, the initial prices of drugs coming to market and
141	141	118subsequent price changes, changes in industry profit levels, marketing expenses, reverse payment
142	142	119patent settlements, the impact of manufacturer rebates, discounts and other price concessions on
143	143	120net pricing, the availability of alternative drugs or treatments, corporate ownership organizational
144	144	121structure and any other matters as determined by the commission. 7 of 100
145	145	122 SECTION 18. Subsection (g) of said section 8 of said chapter 6D, as so appearing, is
146	146	123hereby amended by striking out the second sentence and inserting in place thereof the following
147	147	1242 sentences:- The report shall be based on the commission’s analysis of information provided at
148	148	125the hearings by witnesses, providers, provider organizations, payers, pharmaceutical
149	149	126manufacturing companies and pharmacy benefit managers, registration data collected under
150	150	127section 11, data collected or analyzed by the center under sections 8, 9, 10 and 10A of chapter
151	151	12812C and any other available information that the commission considers necessary to fulfill its
152	152	129duties under this section as defined in regulations promulgated by the commission. To the extent
153	153	130practicable, the report shall not contain any data that is likely to compromise the financial,
154	154	131competitive or proprietary nature of the information.
155	155	132 SECTION 19. Section 9 of said chapter 6D, as so appearing, is hereby amended by
156	156	133inserting after the word “organization”, in line 72, the following words:- , pharmacy benefit
157	157	134manager, pharmaceutical manufacturing company.
158	158	135 SECTION 20. Said chapter 6D is hereby further amended by inserting after section 15
159	159	136the following section:-
160	160	137 Section 15A. (a) A pharmaceutical manufacturing company shall provide early notice to
161	161	138the commission in a manner described in this section for a: (i) pipeline drug; (ii) generic drug; or
162	162	139(iii) biosimilar drug. The commission shall provide nonconfidential information received under
163	163	140this section to the office of Medicaid, the division of insurance and the group insurance
164	164	141commission.
165	165	142 Early notice under this subsection shall be submitted to the commission in writing not
166	166	143later than 30 days after receipt of the United States Food and Drug Administration approval date. 8 of 100
167	167	144 For each pipeline drug, early notice shall include a brief description of the: (i) primary
168	168	145disease, health condition or therapeutic area being studied and the indication; (ii) route of
169	169	146administration being studied; (iii) clinical trial comparators; and (iv) estimated date of market
170	170	147entry. To the extent possible, information shall be collected using data fields consistent with
171	171	148those used by the federal National Institutes of Health for clinical trials.
172	172	149 For each pipeline drug, early notice shall include whether the drug has been designated
173	173	150by the United States Food and Drug Administration: (i) as an orphan drug; (ii) for fast track; (iii)
174	174	151as a breakthrough therapy; (iv) for accelerated approval; or (v) for priority review for a new
175	175	152molecular entity; provided, however, that notwithstanding clause (v), submissions for drugs in
176	176	153development that are designated as new molecular entities by the United States Food and Drug
177	177	154Administration shall be provided as soon as practical upon receipt of the relevant designations.
178	178	155For each generic drug, early notice shall include a copy of the drug label approved by the United
179	179	156States Food and Drug Administration.
180	180	157 (b) A pharmaceutical manufacturing company shall provide early notice to the
181	181	158commission if it plans to increase the wholesale acquisition cost of a: (i) brand-name drug by
182	182	159more than 15 per cent per wholesale acquisition cost unit during any 12-month period; or (ii)
183	183	160generic drug or biosimilar drug with a significant price increase as determined by the
184	184	161commission during any 12-month period. The commission shall provide non-confidential
185	185	162information received under this section to the office of Medicaid, the division of insurance and
186	186	163the group insurance commission.
187	187	164 Early notice under this subsection shall be submitted to the commission in writing not
188	188	165less than 60 days before the planned effective date of the increase. 9 of 100
189	189	166 A pharmaceutical manufacturing company required to notify the commission of a price
190	190	167increase under this subsection shall, not less than 30 days before the planned effective date of the
191	191	168increase, report to the commission any information regarding the price increase that is relevant to
192	192	169the commission including, but not limited to: (i) drug identification information; (ii) drug sales
193	193	170volume information; (iii) wholesale price and related information for the drug; (iv) net price and
194	194	171related information for the drug; (v) drug acquisition information, if applicable; (vi) revenue
195	195	172from the sale of the drug; and (vii) manufacturer costs.
196	196	173 (c) The commission shall conduct an annual study of pharmaceutical manufacturing
197	197	174companies subject to the requirements in subsections (a) and (b). The commission may contract
198	198	175with a third-party entity to implement this section.
199	199	176 (d) If a pharmaceutical manufacturing company fails to timely comply with the
200	200	177requirements under subsection (a) or subsection (b), or otherwise knowingly obstructs the
201	201	178commission’s ability to receive early notice under this section, including, but not limited to,
202	202	179providing incomplete, false or misleading information, the commission may impose appropriate
203	203	180sanctions against the manufacturer, including reasonable monetary penalties not to exceed
204	204	181$500,000, in each instance. The commission shall seek to promote compliance with this section
205	205	182and shall only impose a civil penalty on the manufacturer as a last resort. Amounts collected
206	206	183under this section shall be deposited into the Prescription Drug Cost Assistance Trust Fund
207	207	184established in section 2EEEEEE of chapter 29.
208	208	185 SECTION 21. Said chapter 6D is hereby further amended by adding the following 3
209	209	186sections:- 10 of 100
210	210	187 Section 21. (a) As used in this section, the following words shall have the following
211	211	188meanings unless the context clearly requires otherwise:
212	212	189 “Eligible drug”, (i) a brand name drug or biologic, not including a biosimilar, that has a
213	213	190launch wholesale acquisition cost of $50,000 or more for a 1-year supply or full course of
214	214	191treatment; (ii) a biosimilar drug that has a launch wholesale acquisition cost that is not at least 15
215	215	192per cent lower than the referenced brand biologic at the time the biosimilar is launched; (iii) a
216	216	193public health essential drug, as defined in subsection (f) of section 13 of chapter 17, with a
217	217	194significant price increase over a defined period of time as determined by the commission by
218	218	195regulation or with a wholesale acquisition cost of $25,000 or more for a 1-year supply or full
219	219	196course of treatment; (iv) all drugs, continuous glucose monitoring system components, all
220	220	197components of the continuous glucose monitoring system of which the component is a part and,
221	221	198when applicable, delivery devices selected pursuant to section 17T of chapter 32A, section 10R
222	222	199of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of
223	223	200chapter 176B and section 4NN of chapter 176G; or (v) other prescription drug products that may
224	224	201have a direct and significant impact and create affordability challenges for the state’s health care
225	225	202system and patients, as determined by the commission; provided, however, that the commission
226	226	203shall promulgate regulations to establish the type of prescription drug products classified under
227	227	204clause (v) prior to classification of any such prescription drug product under said clause (v).
228	228	205 “Manufacturer”, a pharmaceutical manufacturer of an eligible drug, or, when applicable,
229	229	206the manufacturer of a delivery device selected pursuant to section 17T of chapter 32A, section
230	230	20710R of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV
231	231	208of chapter 176B and section 4NN of chapter 176G. 11 of 100
232	232	209 “Public health essential drug”, shall have the same meaning as defined in subsection (f)
233	233	210of section 13 of chapter 17.
234	234	211 (b) The commission shall review the impact of eligible drug costs on patient access;
235	235	212provided, however, that the commission may prioritize the review of eligible drugs based on
236	236	213potential impact to consumers.
237	237	214 In conducting a review of eligible drugs, the commission may request information
238	238	215relating to the pricing of an eligible drug from the manufacturer of said eligible drug. Upon
239	239	216receiving a request for information from the commission, a manufacturer shall disclose to the
240	240	217commission, within a reasonable time period, as determined by the commission, applicable
241	241	218information relating to the manufacturer’s pricing of an eligible drug.
242	242	219 The disclosed information shall be on a standard reporting form developed by the
243	243	220commission with the input of the manufacturers and shall include, but not be limited to:
244	244	221 (i) a schedule of the drug’s wholesale acquisition cost increases over the previous 5
245	245	222calendar years;
246	246	223 (ii) the total amount of federal and state tax credits, incentives, grants and other subsidies
247	247	224provided to the manufacturer over the previous 10 calendar years that have been used to assist in
248	248	225the research and development of eligible drugs;
249	249	226 (iii) the manufacturer’s aggregate, company-level research and development and other
250	250	227relevant capital expenditures, including facility construction, for the most recent year for which
251	251	228final audited data are available; 12 of 100
252	252	229 (iv) a narrative description, absent proprietary information and written in plain language,
253	253	230of factors that contributed to reported changes in wholesale acquisition cost during the previous 5
254	254	231calendar years; and
255	255	232 (v) any other information that the manufacturer wishes to provide to the commission or
256	256	233that the commission requests.
257	257	234 (c) Based on the records provided under subsection (b) and available information from
258	258	235the center for health information and analysis or an outside third party, the commission shall
259	259	236identify a proposed value for the eligible drug. The commission may request additional relevant
260	260	237information that it deems necessary from the manufacturer and from other entities, including, but
261	261	238not limited to, pharmacy benefit managers.
262	262	239 Any information, analyses or reports regarding an eligible drug review shall be provided
263	263	240to the manufacturer. The commission shall consider any clarifications or data provided by the
264	264	241manufacturer with respect to the eligible drug. The commission shall not base its determination
265	265	242on the proposed value of the eligible drug solely on the analysis or research of an outside third
266	266	243party and shall not employ a measure or metric that assigns a reduced value to the life extension
267	267	244provided by a treatment based on a pre-existing disability or chronic health condition of the
268	268	245individuals whom the treatment would benefit. If the commission relies upon a third party to
269	269	246provide cost-effectiveness analysis or research related to the proposed value of the eligible drug,
270	270	247such analysis or research shall also include, but not be limited to: (i) a description of the
271	271	248methodologies and models used in its analysis; (ii) any assumptions and potential limitations of
272	272	249research findings in the context of the results; and (iii) outcomes for affected subpopulations that
273	273	250utilize the drug, including, but not limited to, potential impacts on individuals of marginalized 13 of 100
274	274	251racial or ethnic groups and on individuals with specific disabilities or health conditions who
275	275	252regularly utilize the eligible drug.
276	276	253 (d) If, after review of an eligible drug and after receiving information from the
277	277	254manufacturer under subsection (b) or subsection (e), the commission determines that the
278	278	255manufacturer’s pricing of the eligible drug does not substantially exceed the proposed value of
279	279	256the drug, the commission shall notify the manufacturer, in writing, of its determination and shall
280	280	257evaluate other ways to mitigate the eligible drug’s cost in order to improve patient access to the
281	281	258eligible drug. The commission may engage with the manufacturer and other relevant
282	282	259stakeholders, including, but not limited to, patients, patient advocacy organizations, consumer
283	283	260advocacy organizations, providers, provider organizations and payers, to explore options for
284	284	261mitigating the cost of the eligible drug. Upon the conclusion of a stakeholder engagement
285	285	262process under this subsection, the commission shall issue recommendations on ways to reduce
286	286	263the cost of the eligible drug for the purpose of improving patient access to the eligible drug.
287	287	264Recommendations may include, but shall not be limited to: (i) an alternative payment plan or
288	288	265methodology; (ii) a bulk purchasing program; (iii) co-payment, deductible, co-insurance or other
289	289	266cost-sharing restrictions; and (iv) a reinsurance program to subsidize the cost of the eligible drug.
290	290	267The recommendations shall be publicly posted on the commission’s website and provided to the
291	291	268clerks of the house of representatives and senate, the joint committee on health care financing
292	292	269and the house and senate committees on ways and means; provided, however, that the report
293	293	270shall be published on the website of the commission.
294	294	271 (e) If, after review of an eligible drug, the commission determines that the manufacturer’s
295	295	272pricing of the eligible drug substantially exceeds the proposed value of the drug, the commission
296	296	273shall request that the manufacturer provide further information related to the pricing of the 14 of 100
297	297	274eligible drug and the manufacturer’s reasons for the pricing not later than 30 days after receiving
298	298	275the request.
299	299	276 (f) Not later than 60 days after receiving information from the manufacturer under
300	300	277subsection (b) or subsection (e), the commission shall confidentially issue a determination on
301	301	278whether the manufacturer’s pricing of an eligible drug substantially exceeds the commission’s
302	302	279proposed value of the drug. If the commission determines that the manufacturer’s pricing of an
303	303	280eligible drug substantially exceeds the proposed value of the drug, the commission shall
304	304	281confidentially notify the manufacturer, in writing, of its determination and may require the
305	305	282manufacturer to enter into an access and affordability improvement plan under section 22.
306	306	283 (g) Records disclosed by a manufacturer under this section shall: (i) be accompanied by
307	307	284an attestation that all information provided is true and correct; (ii) not be public records under
308	308	285clause Twenty-sixth of section 7 of chapter 4 or under chapter 66; and (iii) remain confidential;
309	309	286provided, however, that the commission may produce reports summarizing any findings;
310	310	287provided further, that any such report shall not be in a form that identifies specific prices charged
311	311	288for or rebate amounts associated with drugs by a manufacturer or in a manner that is likely to
312	312	289compromise the financial, competitive or proprietary nature of the information.
313	313	290 Any request for further information made by the commission under subsection (e) or any
314	314	291determination issued or written notification made by the commission under subsection (f) shall
315	315	292not be public records under said clause Twenty-sixth of said section 7 of said chapter 4 or under
316	316	293said chapter 66.
317	317	294 (h) The commission’s proposed value of an eligible drug and the commission’s
318	318	295underlying analysis of the eligible drug is not intended to be used to determine whether any 15 of 100
319	319	296individual patient meets prior authorization or utilization management criteria for the eligible
320	320	297drug. The proposed value and underlying analysis shall not be the sole factor in determining
321	321	298whether a drug is included in a formulary or whether the drug is subject to step therapy.
322	322	299 (i) If the manufacturer fails to timely comply with the commission’s request for records
323	323	300under subsection (b) or subsection (e), or otherwise knowingly obstructs the commission’s
324	324	301ability to issue its determination under subsection (f), including, but not limited to, by providing
325	325	302incomplete, false or misleading information, the commission may impose appropriate sanctions
326	326	303against the manufacturer, including reasonable monetary penalties not to exceed $500,000, in
327	327	304each instance. The commission shall seek to promote compliance with this section and shall only
328	328	305impose a civil penalty on the manufacturer as a last resort. Penalties collected under this
329	329	306subsection shall be deposited into the Prescription Drug Cost Assistance Trust Fund established
330	330	307in section 2EEEEEE of chapter 29.
331	331	308 (j) The commission shall adopt any written policies, procedures or regulations that the
332	332	309commission determines are necessary to effectuate the purpose of this section.
333	333	310 Section 22. (a) The commission shall establish procedures to assist manufacturers in
334	334	311filing and implementing an access and affordability improvement plan.
335	335	312 Upon providing written notice provided under subsection (f) of section 21, the
336	336	313commission may require that a manufacturer whose pricing of an eligible drug substantially
337	337	314exceeds the commission’s proposed value of the drug file an access and affordability
338	338	315improvement plan with the commission. Not later than 45 days after receipt of a notice under
339	339	316said subsection (f) of said section 21, a manufacturer shall: (i) file an access and affordability 16 of 100
340	340	317improvement plan; or (ii) provide written notice declining participation in the access and
341	341	318affordability improvement plan.
342	342	319 (b) An access and affordability improvement plan shall: (i) be generated by the
343	343	320manufacturer; (ii) identify the reasons for the manufacturer’s drug price; and (iii) include, but not
344	344	321be limited to, specific strategies, adjustments and action steps the manufacturer proposes to
345	345	322implement to address the cost of the eligible drug in order to improve the accessibility and
346	346	323affordability of the eligible drug for patients and the state’s health system. The proposed access
347	347	324and affordability improvement plan shall include specific identifiable and measurable expected
348	348	325outcomes and a timetable for implementation. The timetable for an access and affordability
349	349	326improvement plan shall not exceed 18 months.
350	350	327 (c) The commission shall approve any access and affordability improvement plan that it
351	351	328determines: (i) is reasonably likely to address the cost of an eligible drug in order to substantially
352	352	329improve the accessibility and affordability of the eligible drug for patients and the state’s health
353	353	330system; and (ii) has a reasonable expectation for successful implementation.
354	354	331 (d) If the commission determines that the proposed access and affordability improvement
355	355	332plan is unacceptable or incomplete, the commission may provide consultation on the criteria that
356	356	333have not been met and may allow an additional time period of not more than 30 calendar days for
357	357	334resubmission; provided, however, that all aspects of the access plan shall be proposed by the
358	358	335manufacturer and the commission shall not require specific elements for approval.
359	359	336 (e) Upon approval of the proposed access and affordability improvement plan, the
360	360	337commission shall notify the manufacturer to begin immediate implementation of the access and
361	361	338affordability improvement plan. Public notice shall be provided by the commission on its 17 of 100
362	362	339website, identifying that the manufacturer is implementing an access and affordability
363	363	340improvement plan; provided, however, that upon the successful completion of the access and
364	364	341affordability improvement plan, the identity of the manufacturer shall be removed from the
365	365	342commission's website. All manufacturers implementing an approved access improvement plan
366	366	343shall be subject to additional reporting requirements and compliance monitoring as determined
367	367	344by the commission. The commission shall provide assistance to the manufacturer in the
368	368	345successful implementation of the access and affordability improvement plan.
369	369	346 (f) All manufacturers shall work in good faith to implement the access and affordability
370	370	347improvement plan. At any point during the implementation of the access and affordability
371	371	348improvement plan, the manufacturer may file amendments to the access improvement plan,
372	372	349subject to approval of the commission.
373	373	350 (g) At the conclusion of the timetable established in the access and affordability
374	374	351improvement plan, the manufacturer shall report to the commission regarding the outcome of the
375	375	352access and affordability improvement plan. If the commission determines that the access and
376	376	353affordability improvement plan was unsuccessful, the commission shall: (i) extend the
377	377	354implementation timetable of the existing access and affordability improvement plan; (ii) approve
378	378	355amendments to the access and affordability improvement plan as proposed by the manufacturer;
379	379	356(iii) require the manufacturer to submit a new access and affordability improvement plan; or (iv)
380	380	357waive or delay the requirement to file any additional access and affordability improvement plans.
381	381	358 (h) The commission shall submit a recommendation for proposed legislation to the joint
382	382	359committee on health care financing if the commission determines that further legislative 18 of 100
383	383	360authority is needed to assist manufacturers with the implementation of access and affordability
384	384	361improvement plans or to otherwise ensure compliance with this section.
385	385	362 (i) An access and affordability improvement plan under this section shall remain
386	386	363confidential in accordance with section 2A.
387	387	364 (j) The commission may assess a civil penalty to a manufacturer of not more than
388	388	365$500,000, in each instance, if the commission determines that the manufacturer: (i) declined or
389	389	366willfully neglected to file an access and affordability improvement plan with the commission
390	390	367under subsection (a); (ii) failed to file an acceptable access and affordability improvement plan in
391	391	368good faith with the commission; (iii) failed to implement the access and affordability
392	392	369improvement plan in good faith; or (iv) knowingly failed to provide information required by this
393	393	370section to the commission or knowingly falsified the information. The commission shall seek to
394	394	371promote compliance with this section and shall only impose a civil penalty as a last resort.
395	395	372Penalties collected under this subsection shall be deposited into the Prescription Drug Cost
396	396	373Assistance Trust Fund established in section 2EEEEEE of chapter 29.
397	397	374 (k) If a manufacturer declines to enter into an access and affordability improvement plan
398	398	375under this section, the commission may publicly post the proposed value of the eligible drug,
399	399	376hold a public hearing on the proposed value of the eligible drug and solicit public comment. The
400	400	377manufacturer shall appear and testify at the public hearing held on the eligible drug’s proposed
401	401	378value. Upon the conclusion of a public hearing under this subsection, the commission shall issue
402	402	379recommendations on ways to reduce the cost of an eligible drug for the purpose of improving
403	403	380patient access to the eligible drug. The recommendations shall be publicly posted on the
404	404	381commission’s website and provided to the clerks of the house of representatives and senate, the 19 of 100
405	405	382joint committee on health care financing and the house and senate committees on ways and
406	406	383means.
407	407	384 If a manufacturer is deemed to not be acting in good faith to develop an acceptable or
408	408	385complete access and affordability improvement plan, the commission may publicly post the
409	409	386proposed value of the eligible drug, hold a public hearing on the proposed value of the eligible
410	410	387drug and solicit public comment. The manufacturer shall appear and testify at any hearing held
411	411	388on the eligible drug’s proposed value. Upon the conclusion of a public hearing under this
412	412	389subsection, the commission shall issue recommendations on ways to reduce the cost of an
413	413	390eligible drug for the purpose of improving patient access to the eligible drug. The
414	414	391recommendations shall be publicly posted on the commission’s website and provided to the
415	415	392clerks of the house of representatives and senate, the joint committee on health care financing
416	416	393and the house and senate committees on ways and means.
417	417	394 Before making a determination that the manufacturer is not acting in good faith, the
418	418	395commission shall send a written notice to the manufacturer that the commission shall deem the
419	419	396manufacturer to not be acting in good faith if the manufacturer does not submit an acceptable
420	420	397access and affordability improvement plan within 30 days of receipt of notice; provided,
421	421	398however, that the commission shall not send a notice under this paragraph within 120 calendar
422	422	399days from the date that the commission notified the manufacturer of its requirement to enter into
423	423	400the access and affordability improvement plan.
424	424	401 (l) The commission shall promulgate regulations necessary to implement this section.
425	425	402 Section 23. Every 2 years, the commission, in consultation with the center for health
426	426	403information and analysis, the group insurance commission, the office of Medicaid and the 20 of 100
427	427	404division of insurance shall evaluate the impact of section 17T of chapter 32A, section 10R of
428	428	405chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of
429	429	406chapter 176B and section 4NN of chapter 176G on the effects of capping co-payments and
430	430	407eliminating deductible and co-insurance requirements for those drugs for individuals with
431	431	408diabetes, asthma and chronic heart conditions on health care access and system cost, including,
432	432	409but not limited to: (i) utilization rates of the drugs selected pursuant to section 10R of chapter
433	433	410118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of chapter 176B
434	434	411and section 4NN of chapter 176G; (ii) an analysis of the use of those drugs, broken down by
435	435	412patient demographics, geographic region and, where applicable, delivery device; (iii) annual plan
436	436	413costs and member premiums; (iv) the average price of those drugs; (v) the average price of those
437	437	414drugs net of rebates or discounts received by or accrued directly or indirectly by health insurance
438	438	415carriers; (vi) average and total out-of-pocket expenditures on delivery devices used for those
439	439	416drugs and glucose monitoring tests that are not included as part of the underlying drug
440	440	417prescription; (vii) an analysis of the impact of capping co-payments and eliminating deductible
441	441	418and co-insurance requirements for those drugs on patient access to and cost of care by patient
442	442	419demographics and geographic region; and (viii) any barriers to accessing those drugs for
443	443	420individuals with the conditions for which those drugs are prescribed and policy recommendations
444	444	421for resolving such barriers. This section shall also apply to selected continuous glucose
445	445	422monitoring system components, all components of the continuous glucose monitoring system of
446	446	423which the component is a part and delivery devices, when applicable.
447	447	424 Biennially, not later than November 30, the commission shall file a report of its findings
448	448	425with the clerks of the house of representatives and senate, the chairs of the joint committee on 21 of 100
449	449	426public health, the chairs of the joint committee on health care financing and the chairs of house
450	450	427and senate committees on ways and means.
451	451	428 SECTION 22. Section 1 of chapter 12C of the General Laws, as appearing in the 2022
452	452	429Official Edition, is hereby amended by inserting after the definition of “Ambulatory surgical
453	453	430center services” the following 3 definitions:-
454	454	431 “Average manufacturer price”, the average price paid to a manufacturer for a drug in the
455	455	432commonwealth by a: (i) wholesaler for drugs distributed to pharmacies; and (ii) pharmacy that
456	456	433purchases drugs directly from the manufacturer.
457	457	434 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license
458	458	435application approved under 42 U.S.C. 262(k)(3).
459	459	436 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
460	460	437drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
461	461	438application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
462	462	439is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
463	463	440Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
464	464	441application that was approved by the United States Secretary of Health and Human Services
465	465	442under section 505(c) of the federal Food, Drug and Cosmetic Act, 21 U.S.C. 355(c), before the
466	466	443date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
467	467	4441984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
468	468	445C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
469	469	446under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the carrier as a brand name drug based on
470	470	447available data resources such as Medi-Span. 22 of 100
471	471	448 SECTION 23. Said section 1 of said chapter 12C, as so appearing, is hereby further
472	472	449amended by inserting after the definition of “General health supplies, care or rehabilitative
473	473	450services and accommodations” the following definition:-
474	474	451 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
475	475	452abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
476	476	453drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
477	477	454that was not originally marketed under a new drug application; or (iv) identified by the carrier as
478	478	455a generic drug based on available data resources such as Medi-Span.
479	479	456 SECTION 24. Said section 1 of said chapter 12C, as so appearing, is hereby further
480	480	457amended by inserting after the definition of “Patient-centered medical home” the following 2
481	481	458definitions:-
482	482	459 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
483	483	460preparation, propagation, compounding, conversion or processing of prescription drugs, directly
484	484	461or indirectly, by extraction from substances of natural origin, independently by means of
485	485	462chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
486	486	463repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
487	487	464“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed
488	488	465under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
489	489	466chapter 112.
490	490	467 “Pharmacy benefit manager”, a person, business or other entity, however organized, that,
491	491	468directly or through a subsidiary, provides pharmacy benefit management services for prescription
492	492	469drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self- 23 of 100
493	493	470insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
494	494	471management services shall include, but not be limited to: (i) the processing and payment of
495	495	472claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing
496	496	473of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or
497	497	474grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii)
498	498	475drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x)
499	499	476clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of
500	500	477covered prescription drugs; provided further, that “pharmacy benefit manager” shall include a
501	501	478health benefit plan sponsor that does not contract with a pharmacy benefit manager and manages
502	502	479its own prescription drug benefits unless specifically exempted by the commission.
503	503	480 SECTION 25. Said section 1 of said chapter 12C, as so appearing, is hereby further
504	504	481amended by adding the following definition:-
505	505	482 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C.
506	506	4831395w-3a(c)(6)(B).
507	507	484 SECTION 26. Section 3 of said chapter 12C, as so appearing, is hereby amended by
508	508	485inserting after the word “organizations”, in lines 13 and 14, the following words:- ,
509	509	486pharmaceutical manufacturing companies, pharmacy benefit managers.
510	510	487 SECTION 27. Said section 3 of said chapter 12C, as so appearing, is hereby further
511	511	488amended by striking out, in line 24, the words “and payer” and inserting in place thereof the
512	512	489following words:- , payer, pharmaceutical manufacturing company and pharmacy benefit
513	513	490manager. 24 of 100
514	514	491 SECTION 28. Section 5 of said chapter 12C, as so appearing, is hereby amended by
515	515	492striking out, in lines 11 and 12, the words “and public health care payers” and inserting in place
516	516	493thereof the following words:- , public health care payers, pharmaceutical manufacturing
517	517	494companies and pharmacy benefit managers.
518	518	495 SECTION 29. Said section 5 of said chapter 12C, as so appearing, is hereby further
519	519	496amended by striking out, in line 15, the words “and affected payers” and inserting in place
520	520	497thereof the following words:- affected payers, affected pharmaceutical manufacturing companies
521	521	498and affected pharmacy benefit managers.
522	522	499 SECTION 30. The first paragraph of section 7 of said chapter 12C, as so appearing, is
523	523	500hereby amended by adding the following sentence:- Each pharmaceutical and biopharmaceutical
524	524	501manufacturing company and pharmacy benefit manager shall pay to the commonwealth an
525	525	502amount for the estimated expenses of the center and for the other purposes described in this
526	526	503chapter.
527	527	504 SECTION 31. Said section 7 of said chapter 12C, as so appearing, is hereby further
528	528	505amended by striking out, in lines 8 and 42, the figure “33” and inserting in place thereof, in each
529	529	506instance, the following figure:- 25.
530	530	507 SECTION 32. Said section 7 of said chapter 12C, as so appearing, is hereby further
531	531	508amended by adding the following paragraph:-
532	532	509 The assessed amount for pharmaceutical and biopharmaceutical manufacturing
533	533	510companies and pharmacy benefit managers shall be not less than 25 per cent of the amount
534	534	511appropriated by the general court for the expenses of the center minus amounts collected from:
535	535	512(i) filing fees; (ii) fees and charges generated by the commission's publication or dissemination 25 of 100
536	536	513of reports and information; and (iii) federal matching revenues received for these expenses or
537	537	514received retroactively for expenses of predecessor agencies. A pharmacy benefit manager that is
538	538	515also a surcharge payor subject to the preceding paragraph and manages its own prescription drug
539	539	516benefits shall not be subject to additional assessment under this paragraph.
540	540	517 SECTION 33. Said chapter 12C is hereby further amended by inserting after section 10
541	541	518the following section:-
542	542	519 Section 10A. (a) The center shall promulgate regulations necessary to ensure the uniform
543	543	520reporting of information from pharmaceutical manufacturing companies to enable the center to
544	544	521analyze: (i) year-over-year changes in wholesale acquisition cost and average manufacturer price
545	545	522for prescription drug products; (ii) year-over-year trends in net expenditures; (iii) net
546	546	523expenditures on subsets of biosimilar, brand name and generic drugs identified by the center; (iv)
547	547	524trends in estimated aggregate drug rebates, discounts or other remuneration paid or provided by a
548	548	525pharmaceutical manufacturing company to a pharmacy benefit manager, wholesaler, distributor,
549	549	526health carrier client, health plan sponsor or pharmacy in connection with utilization of the
550	550	527pharmaceutical drug products offered by the pharmaceutical manufacturing company; (v)
551	551	528discounts provided by a pharmaceutical manufacturing company to a consumer in connection
552	552	529with utilization of the pharmaceutical drug products offered by the pharmaceutical
553	553	530manufacturing company, including any discount, rebate, product voucher, coupon or other
554	554	531reduction in a consumer’s out-of-pocket expenses including co-payments and deductibles under
555	555	532section 3 of chapter 175H; (vi) research and development costs as a percentage of revenue; (vii)
556	556	533annual marketing and advertising costs, identifying costs for direct-to-consumer advertising;
557	557	534(viii) annual profits over the most recent 5-year period; (ix) disparities between prices charged to 26 of 100
558	558	535purchasers in the commonwealth and purchasers outside of the United States; and (x) any other
559	559	536information deemed necessary by the center.
560	560	537 The center shall require the submission of available data and other information from
561	561	538pharmaceutical manufacturing companies including, but not limited to: (i) wholesale acquisition
562	562	539costs and average manufacturer prices for prescription drug products as identified by the center;
563	563	540(ii) true net typical prices charged to pharmacy benefits managers by payor type for prescription
564	564	541drug products identified by the center, net of any rebate or other payments from the manufacturer
565	565	542to the pharmacy benefits manager and from the pharmacy benefits manager to the manufacturer;
566	566	543(iii) aggregate, company-level research and development costs to the extent attributable to a
567	567	544specific product and other relevant capital expenditures for the most recent year for which final
568	568	545audited data is available for prescription drug products as identified by the center; (iv) annual
569	569	546marketing and advertising expenditure; (v) the total amount of federal and state tax credits,
570	570	547incentives, grants and other subsidies provided to the manufacturer over the previous 10 calendar
571	571	548years that have been used to assist in the research and development of eligible drugs; and (vi) a
572	572	549description, absent proprietary information and written in plain language, of factors that
573	573	550contributed to reported changes in wholesale acquisition costs, net prices and average
574	574	551manufacturer prices for prescription drug products as identified by the center.
575	575	552 (b) The center shall promulgate regulations necessary to ensure the uniform reporting of
576	576	553information from pharmacy benefit managers to enable the center to analyze: (i) trends in
577	577	554estimated aggregate drug rebates and other drug price reductions, if any, provided by a pharmacy
578	578	555benefit manager to a health carrier client or health plan sponsor or passed through from a
579	579	556pharmacy benefit manager to a health carrier client or health plan sponsor in connection with
580	580	557utilization of drugs in the commonwealth offered through the pharmacy benefit manager and a 27 of 100
581	581	558measure of lives covered by each health carrier client or health plan sponsor in the
582	582	559commonwealth; (ii) pharmacy benefit manager practices with regard to drug rebates and other
583	583	560drug price reductions, if any, provided by a pharmacy benefit manager to a health carrier client
584	584	561or health plan sponsor or to consumers in the commonwealth or passed through from a pharmacy
585	585	562benefit manager to a health carrier client or health plan sponsor or to consumers in the
586	586	563commonwealth; and (iii) any other information deemed necessary by the center.
587	587	564 The center shall require the submission of available data and other information from
588	588	565pharmacy benefit managers including, but not limited to: (i) true net typical prices paid by
589	589	566pharmacy benefits managers for prescription drug products identified by the center, net of any
590	590	567rebate or other payments from the manufacturer to the pharmacy benefit manager and from the
591	591	568pharmacy benefit manager to the manufacturer; (ii) the amount of all rebates that the pharmacy
592	592	569benefit manager received from all pharmaceutical manufacturing companies: (A) for all health
593	593	570carrier clients in the aggregate; (B) for each health carrier client or health plan sponsor
594	594	571individually; and (C) by drug, for 30 of the most utilized drugs in the commonwealth as
595	595	572determined by the center; (iii) the administrative fees that the pharmacy benefit manager
596	596	573received from all health carrier clients or health plan sponsors in the aggregate and for each
597	597	574health carrier client or health plans sponsors individually; (iv) the aggregate amount of rebates a
598	598	575pharmacy benefit manager: (A) retains based on its contractual arrangement with each health
599	599	576plan client or health plan sponsor individually; and (B) passes through to each health care client
600	600	577individually; (v) the aggregate amount of all retained rebates that the pharmacy benefit manager
601	601	578received from all pharmaceutical manufacturing companies and did not pass through to each
602	602	579pharmacy benefit manager’s health carrier client or health plan sponsor individually; (vi) the
603	603	580percentage of contracts that a pharmacy benefit manager holds where the pharmacy benefit 28 of 100
604	604	581manager: (A) retains all rebates; (B) passes all rebates through to the client; and (C) shares
605	605	582rebates with the client; and (vii) other information as determined by the center, including, but not
606	606	583limited to, pharmacy benefit manager practices related to spread pricing, administrative fees,
607	607	584claw backs and formulary placement.
608	608	585 (c) Except as specifically provided otherwise by the center or under this chapter, data
609	609	586collected by the center pursuant to this section from pharmaceutical manufacturing companies
610	610	587and pharmacy benefit managers shall not be a public record under clause Twenty-sixth of section
611	611	5887 of chapter 4 or under chapter 66.
612	612	589 SECTION 34. Said chapter 12C is hereby further amended by striking out section 11, as
613	613	590appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
614	614	591 Section 11. The center shall ensure the timely reporting of information required under
615	615	592sections 8, 9, 10 and 10A. The center shall notify private health care payers, providers, provider
616	616	593organizations, pharmacy benefit managers, pharmaceutical manufacturing companies and their
617	617	594parent organization and other affiliates of any applicable reporting deadlines. The center shall
618	618	595notify, in writing, a private health care payer, provider, provider organization, pharmacy benefit
619	619	596manager or pharmaceutical manufacturing company and their parent organization and other
620	620	597affiliates, that has failed to meet a reporting deadline of such failure and that failure to respond
621	621	598within 2 weeks of the receipt of the notice shall result in penalties. The center shall assess a
622	622	599penalty against a private health care payer, provider, provider organization, pharmacy benefit
623	623	600manager or pharmaceutical manufacturing company and their parent organization and other
624	624	601affiliates, that fails, without just cause, to provide the requested information, including subsets of
625	625	602the requested information, within 2 weeks following receipt of the written notice required under 29 of 100
626	626	603this section, of not more than $2,000 per week for each week of delay after the 2-week period
627	627	604following receipt of the notice. Amounts collected under this section shall be deposited in the
628	628	605Healthcare Payment Reform Fund established in section 100 of chapter 194 of the acts of 2011.
629	629	606The center may promulgate regulations to define “just cause” for the purpose of this section.
630	630	607 SECTION 35. Section 12 of said chapter 12C, as so appearing, is hereby amended by
631	631	608striking out, in line 2, the words “and 10” and inserting in place thereof the following words:- ,
632	632	60910 and 10A.
633	633	610 SECTION 36. Subsection (a) of section 16 of said chapter 12C, as so appearing, is hereby
634	634	611amended by striking out the first sentence and inserting in place thereof the following sentence:-
635	635	612The center shall publish an annual report based on the information submitted under: (i) sections
636	636	6138, 9, 10 and 10A concerning health care provider, provider organization, private and public
637	637	614health care payer, pharmaceutical manufacturing company and pharmacy benefit manager costs
638	638	615and cost and price trends; (ii) section 13 of chapter 6D relative to market power reviews; and (iii)
639	639	616section 15 of said chapter 6D relative to quality data.
640	640	617 SECTION 37. Said section 16 of said chapter 12C, as so appearing, is hereby further
641	641	618amended by striking out, in line 18, the words:- “in the aggregate”.
642	642	619 SECTION 38. Said section 16 of said chapter 12C, as so appearing, is hereby further
643	643	620amended by inserting after the second paragraph the following paragraph:-
644	644	621 As part of its annual report, the center shall report on prescription drug utilization and
645	645	622spending for pharmaceutical drugs provided in an outpatient setting or sold in a retail setting for
646	646	623private and public health care payers, including, but not limited to, information sufficient to
647	647	624show the: (i) highest utilization drugs; (ii) drugs with the greatest increases in utilization; (iii) 30 of 100
648	648	625drugs that are most impactful on plan spending, net of rebates; and (iv) drugs with the highest
649	649	626year-over-year price increases, net of rebates. The report shall not contain any data that is likely
650	650	627to compromise the financial, competitive or proprietary nature of the information contained in
651	651	628the report. The report shall be published on the website of the center.
652	652	629 SECTION 39. Section 13 of chapter 17 of the General Laws, as so appearing, is hereby
653	653	630amended by adding the following subsection:-
654	654	631 (f) As used in this subsection, the following words shall have the following meanings
655	655	632unless the context clearly requires otherwise:
656	656	633 “Public health essential drug”, a prescription drug, biologic or biosimilar approved by the
657	657	634United States Food and Drug Administration that: (i) appears on the Model List of Essential
658	658	635Medicines most recently adopted by the World Health Organization; (ii) is selected pursuant to
659	659	636section 17T of chapter 32A, section 10R of chapter 118E, section 47UU of chapter 175, section
660	660	6378VV of chapter 176A, section 4VV of chapter 176B and section 4NN of chapter 176G; or (iii) is
661	661	638deemed an essential medicine by the commission due to its efficacy in treating a life-threatening
662	662	639health condition or a chronic health condition that substantially impairs an individual’s ability to
663	663	640engage in activities of daily living or because limited access to a certain population would pose a
664	664	641public health challenge. “Public health essential drug” shall also include all continuous glucose
665	665	642monitoring system components, all components of the continuous glucose monitoring system of
666	666	643which the component is a part and delivery devices selected pursuant to section 17T of chapter
667	667	64432A, section 10R of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A,
668	668	645section 4VV of chapter 176B and section 4NN of chapter 176G. 31 of 100
669	669	646 The commission shall identify and publish a list of public health essential drugs. The list
670	670	647shall be updated not less than annually and be made publicly available on the department’s
671	671	648website; provided, however, that the commission may provide an interim listing of a public
672	672	649health essential drug prior to an annual update. The commission shall notify and forward a copy
673	673	650of the list to the health policy commission established under chapter 6D.
674	674	651 SECTION 40. Chapter 29 of the General Laws is hereby amending by inserting after
675	675	652section 2DDDDDD the following section:-
676	676	653 2EEEEEE. (a) There shall be a Prescription Drug Cost Assistance Trust Fund. The
677	677	654secretary of health and human services shall administer the fund and shall make expenditures
678	678	655from the fund, without further appropriation, to provide financial assistance to residents of the
679	679	656commonwealth for the cost of prescription drugs through the prescription drug costs assistance
680	680	657program established under section 245 of chapter 111. For the purpose of this section,
681	681	658“prescription drug” shall include the prescription drug and any drug delivery device needed to
682	682	659administer the drug that is not included as part of the underlying drug prescription.
683	683	660 The fund shall consist of: (i) revenue from appropriations or other money authorized by
684	684	661the general court and specifically designated to be credited to the fund; and (ii) funds from public
685	685	662or private sources, including, but not limited to, gifts, grants, donations, rebates and settlements
686	686	663received by the commonwealth that are specifically designated to be credited to the fund. Money
687	687	664remaining in the fund at the close of a fiscal year shall not revert to the General Fund and shall
688	688	665be available for expenditure in the following fiscal year.
689	689	666 (b) Annually, not later than March 1, the secretary shall report on the fund’s activities
690	690	667detailing expenditures from the previous calendar year. The report shall include: (i) the number 32 of 100
691	691	668of individuals who received financial assistance from the fund; (ii) the breakdown of fund
692	692	669recipients by race, gender, age range, geographic region and income level; (iii) a list of all
693	693	670prescription drugs that were covered by money from the fund; and (iv) the total cost savings
694	694	671received by all fund recipients and the cost savings broken down by race, gender, age range and
695	695	672income level. The report shall be submitted to the clerks of the senate and house of
696	696	673representatives, senate and house committees on ways and means and the joint committee on
697	697	674health care financing; provided, however, that annually, not later than March 1, the report shall
698	698	675be published on the website of the executive office of health and human services.
699	699	676 (c) The secretary shall promulgate regulations or issue other guidance for the expenditure
700	700	677of the funds under this section.
701	701	678 SECTION 41. Chapter 32A of the General Laws is hereby amended by inserting after
702	702	679section 17S the following section:-
703	703	680 Section 17T. (a) As used in this section, the following words shall have the following
704	704	681meanings unless the context clearly requires otherwise:
705	705	682 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
706	706	683drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
707	707	684application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
708	708	685is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
709	709	686Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
710	710	687application that was approved by the United States Secretary of Health and Human Services
711	711	688under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
712	712	689date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 33 of 100
713	713	6901984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
714	714	691C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
715	715	692under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
716	716	693based on available data resources such as Medi-Span.
717	717	694 “Continuous glucose monitoring system”, a system to continuously sense, transmit and
718	718	695display blood glucose levels.
719	719	696 “Continuous glucose monitoring system component”, a component of a system to
720	720	697continuously monitor blood glucose levels such as a sensor, transmitter or display.
721	721	698 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
722	722	699drug; and (ii) an individual can obtain with a prescription.
723	723	700 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not
724	724	701limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home
725	725	702use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips,
726	726	703lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose
727	727	704monitors for use by the legally blind and visual magnifying aids for use by the legally blind;
728	728	705provided, however, that “diabetes treatment supplies” shall not include a brand name drug, a
729	729	706generic drug, a continuous glucose monitoring system component, or a delivery device.
730	730	707 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
731	731	708abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
732	732	709drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
733	733	710and was not originally marketed under a new drug application; or (iv) identified by the health
734	734	711benefit plan as a generic drug based on available data resources such as Medi-Span. 34 of 100
735	735	712 “Separate delivery device”, a device that is used to deliver a brand name drug or a
736	736	713generic drug and that can be obtained with a prescription separate from, or in addition to, the
737	737	714brand name drug or generic drug that the device delivers.
738	738	715 (b) The commission shall select 1 generic drug and 1 brand name drug used to treat each
739	739	716of the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart
740	740	717conditions that disproportionately impact a particular demographic group, including people of
741	741	718color, as determined by the center for health information analysis; provided, however, that for
742	742	719diabetes, the commission shall also select a continuous glucose monitoring system component.
743	743	720 The commission shall select insulin as the drug used to treat diabetes. In selecting 1
744	744	721insulin brand name drug and 1 insulin generic drug per dosage and type, including rapid-acting,
745	745	722short-acting, intermediate-acting, long-acting, ultra long-acting and premixed, subject to such
746	746	723generic drug’s availability.
747	747	724 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when
748	748	725applicable, used to treat each chronic condition pursuant to subsection (b), the commission shall
749	749	726select a drug that is among the top 3 of the commission’s most prescribed or of the highest
750	750	727volume for the chronic condition and shall consider whether the drug is:
751	751	728 (i) of clear benefit and strongly supported by clinical evidence;
752	752	729 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
753	753	730exacerbations of illness progression or improve quality of life;
754	754	731 (iii) relatively low cost when compared to the cost of an acute illness or incident
755	755	732prevented or delayed by the use of the service, treatment or drug; 35 of 100
756	756	733 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
757	757	734 (v) likely to have a considerable financial impact on individual patients by reducing or
758	758	735eliminating patient cost-sharing pursuant to this section; and
759	759	736 (vi) likely to enhance equity in disproportionately impacted demographic groups,
760	760	737including people of color.
761	761	738 (d) The continuous glucose monitoring system component shall be selected in the same
762	762	739manner in which the 1 generic drug and 1 brand name drug are selected.
763	763	740 (e)(1) The commission shall provide coverage for the brand name drugs and generic
764	764	741drugs selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be
765	765	742subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to
766	766	743any deductible. Coverage for selected brand name drugs shall not be subject to any deductible or
767	767	744co-insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however,
768	768	745that nothing in this section shall prevent co-payments for a 30-day supply of the selected brand
769	769	746name drugs from being reduced below the amount specified in this section.
770	770	747 (2) If use of a brand name drug or generic drug that the commission selects requires a
771	771	748separate delivery device, the commission shall select a delivery device for that drug in
772	772	749accordance with the criteria established in subsection (c) for selecting brand name drugs and
773	773	750generic drugs, to the extent possible. The commission shall provide coverage for the delivery
774	774	751device and the delivery device shall not be subject to any cost-sharing, including co-payments
775	775	752and co-insurance, and shall not be subject to any deductible. 36 of 100
776	776	753 (3) The commission shall provide coverage for the continuous glucose monitoring system
777	777	754component selected pursuant to subsection (b) and all components of the blood glucose
778	778	755monitoring system of which the selected component is a part. All components of the applicable
779	779	756continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
780	780	757payments and co-insurance, and shall not be subject to any deductible.
781	781	758 (4) The commission shall provide coverage for necessary diabetes treatment supplies.
782	782	759Such supplies shall not be subject to any cost-sharing, including co-payments and co-insurance,
783	783	760and shall not be subject to any deductible.
784	784	761 (f) A member and their prescribing health care provider shall have access to a clear,
785	785	762readily accessible and convenient process to request to use a different brand name drug or
786	786	763generic drug of the same pharmacological class in place of a brand name drug or generic drug
787	787	764selected under subsection (b). Such request for an exception shall be granted if: (i) the brand
788	788	765name drugs and generic drugs selected under subsection (b) are contraindicated or will likely
789	789	766cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name drugs
790	790	767and generic drugs selected under subsection (b) are expected to be ineffective based on the
791	791	768known clinical characteristics of the member and the known characteristics of the prescription
792	792	769drug regimen; (iii) the member or prescribing health care provider: (A) has provided
793	793	770documentation to the commission establishing that the member has previously tried the brand
794	794	771name drugs and generic drugs selected under subsection (b) ; and (B) such prescription drug was
795	795	772discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or
796	796	773(iv) the member or prescribing health care provider has provided documentation to the
797	797	774commission establishing that the member: (A) is stable on a prescription drug prescribed by the
798	798	775health care provider; and (B) switching drugs will likely cause an adverse reaction in or physical 37 of 100
799	799	776or mental harm to the member. This subsection shall apply to continuous glucose monitoring
800	800	777system components and, when applicable, delivery devices.
801	801	778 (g) The commission shall implement a continuity of coverage policy for members that are
802	802	779new to the commission, which shall provide coverage for a 90-day fill of a United States Food
803	803	780and Drug Administration-approved drug reimbursed through a pharmacy benefit that the member
804	804	781has already been prescribed and on which the member is stable, upon documentation by the
805	805	782member’s prescriber, and which was selected by the member’s previous payer pursuant to
806	806	783subsection (b); provided, however, that the commission shall not apply any greater deductible,
807	807	784co-insurance, co-payments or out-of-pocket limits than would otherwise apply to other drugs
808	808	785selected pursuant to subsection (b) by the plan; and provided further, that the commission shall
809	809	786provide a member or their prescribing health care provider with information regarding the
810	810	787request pursuant to subsection (f) within 30 days of a member or their health care provider
811	811	788contacting the commission to use a different brand name drug or generic drug of the same
812	812	789pharmacological class as the drugs selected pursuant to subsection (b). This subsection shall
813	813	790apply to continuous glucose monitoring system components and, when applicable, delivery
814	814	791devices.
815	815	792 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
816	816	793coverage pursuant to subsection (g), the commission shall provide coverage for the prescription
817	817	794drug, continuous glucose monitoring system component or delivery device prescribed by the
818	818	795member’s health care provider at the same cost as required under subsection (e). A denial of an
819	819	796exception shall be eligible for appeal by a member. 38 of 100
820	820	797 (i) The commission shall grant or deny a request pursuant to subsection (f) or (g) not
821	821	798more than 3 business days following the receipt of all necessary information to establish the
822	822	799medical necessity of the prescribed treatment; provided, however, that if additional delay would
823	823	800result in significant risk to the member’s health or well-being, the commission shall respond not
824	824	801more than 24 hours following the receipt of all necessary information to establish the medical
825	825	802necessity of the prescribed treatment. If a response by the commission is not received within the
826	826	803time required under this subsection, an exception shall be deemed granted.
827	827	804 (j) The commission shall make changes in selected drugs not more than annually and
828	828	805shall provide notice to the division of insurance not less than 90 days before making changes to
829	829	806the selected drugs and an explanation of such changes. Upon verification by the division of
830	830	807insurance that the selected drugs meet the criteria identified in subsection (c), the commission
831	831	808shall provide notice to its members not less than 30 days before any changes to the selected
832	832	809drugs are made. This subsection shall apply to continuous glucose monitoring system
833	833	810components and, when applicable, delivery devices, in the same manner in which it applies to
834	834	811drugs.
835	835	812 (k) The commission shall make public the drugs, continuous glucose monitoring system
836	836	813components, all components of the system of which the component is a part and delivery devices
837	837	814selected pursuant to this section.
838	838	815 (l) If a high deductible health plan subject to this section is used to establish a savings
839	839	816account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
840	840	817section shall apply to the plan to the maximum extent possible without causing the account to
841	841	818lose its tax-exempt status. 39 of 100
842	842	819 SECTION 42. Chapter 111 of the General Laws is hereby amended by adding the
843	843	820following section:-
844	844	821 Section 245. (a) The department shall establish and administer a prescription drug cost
845	845	822assistance program, which shall be funded by the Prescription Drug Cost Assistance Trust Fund
846	846	823established in section 2EEEEEE of chapter 29. The program shall provide financial assistance
847	847	824for prescription drugs used to treat: (i) chronic respiratory conditions, including, but not limited
848	848	825to, chronic obstructive pulmonary disease and asthma; (ii) chronic heart conditions, including,
849	849	826but not limited to, those heart conditions that disproportionately impact a particular demographic
850	850	827group, including people of color; (iii) diabetes; and (iv) any other chronic condition identified by
851	851	828the department that disproportionately impacts a particular demographic group, including people
852	852	829of color; provided, however, that “prescription drug” shall include the prescription drug and any
853	853	830drug delivery device needed to administer the drug that is not included as part of the underlying
854	854	831drug prescription. Financial assistance shall cover the cost of any copayment, coinsurance and
855	855	832deductible for the prescription drug for an individual who is eligible for the program.
856	856	833 (b) An individual shall be eligible for the program if the individual: (i) is a resident of the
857	857	834commonwealth; (ii) has a current prescription from a health care provider for a drug that is used
858	858	835to treat a chronic condition listed in subsection (a); (iii) has a family income of not more than
859	859	836500 per cent of the federal poverty level; and (iv) is not enrolled in MassHealth.
860	860	837 (c) The department shall create an application process, which shall be available
861	861	838electronically and in hard copy form, to determine whether an individual meets the program
862	862	839eligibility requirements under subsection (b). The department shall determine an applicant’s
863	863	840eligibility and notify the applicant of the department’s determination within 10 business days of 40 of 100
864	864	841receiving the application. If necessary for its determination, the department may request
865	865	842additional information from the applicant; provided, however, that the department shall notify
866	866	843the applicant within 5 business days of receipt of the original application as to what specific
867	867	844additional information is being requested. If additional information is requested, the department
868	868	845shall, within 3 business days of receipt of the additional information, determine the applicant’s
869	869	846eligibility and notify said applicant of the department’s determination.
870	870	847 If the department determines that an applicant is not eligible for the program, the
871	871	848department shall notify the applicant and shall include in said notification the specific reasons
872	872	849why the applicant is not eligible. The applicant may appeal this determination to the department
873	873	850within 30 days of receiving such notification.
874	874	851 If the department determines that an applicant is eligible for the program, the department
875	875	852shall provide the applicant with a prescription drug cost assistance program identification card,
876	876	853which shall indicate the applicant’s eligibility; provided, however, that the program identification
877	877	854card shall include, but not be limited to, the applicant’s full name and the full name of the
878	878	855prescription drug that the applicant is eligible to receive under the program without having to pay
879	879	856a co-payment, co-insurance or deductible. An applicant’s program identification card shall be
880	880	857valid for 12 months and shall be renewable upon a redetermination of program eligibility.
881	881	858 (d) An individual with a valid program identification card may present such card at any
882	882	859pharmacy in the commonwealth and, upon presentation of such card, the pharmacy shall fill the
883	883	860individual’s prescription and provide the prescribed drug to the individual without requiring the
884	884	861individual to pay a co-payment, co-insurance or deductible; provided, however, that the
885	885	862pharmacy shall be reimbursed by the Prescription Drug Cost Assistance Trust Fund established 41 of 100
886	886	863in section 2EEEEEE of chapter 29 in a manner determined by the department, in an amount
887	887	864equal to what the pharmacy would have received had the individual been required to pay a co-
888	888	865payment, co-insurance or deductible.
889	889	866 (e) The department, in collaboration with the division of insurance, board of registration
890	890	867in pharmacy and stakeholders representing consumers, pharmacists, providers, hospitals and
891	891	868carriers, shall develop and implement a plan to educate consumers, pharmacists, providers,
892	892	869hospitals and carriers regarding eligibility for and enrollment in the program under this section.
893	893	870The plan shall include, but not be limited to, appropriate staff training, notices provided to
894	894	871consumers at the pharmacy and a designated website with information for consumers,
895	895	872pharmacists and other health care professionals.
896	896	873 (f) The department shall compile a report detailing information about the program from
897	897	874the previous calendar year. The report shall include: (i) the number of applications received,
898	898	875approved, denied and appealed; (ii) the total number of applicants approved, and the number of
899	899	876applicants approved broken down by race, gender, age range and income level; (iii) a list of all
900	900	877prescription drugs that qualify for the program under subsection (b) and a list of prescription
901	901	878drugs for which applicants actually received financial assistance; and (iv) the total cost savings
902	902	879received by all approved applicants and the cost savings broken down by race, gender, age range
903	903	880and income level. The report shall be submitted annually, not later than March 1, to the clerks of
904	904	881the senate and house of representatives, the house and senate committees on ways and means and
905	905	882the joint committee on health care financing; provided, however, that annually, not later than
906	906	883March 1, the report shall be published on the website of the department. 42 of 100
907	907	884 (g) The department shall promulgate regulations or issue guidance for the implementation
908	908	885and enforcement of this section.
909	909	886 SECTION 43. Chapter 112 of the General Laws is hereby amended by inserting after
910	910	887section 39J the following section:-
911	911	888 Section 39K. (a) For the purposes of this section, “specialty pharmacy” may include any
912	912	889pharmacy engaged in the dispensing of specialty drugs as defined by the board.
913	913	890 The board shall establish a specialty pharmacy licensure category for pharmacies that
914	914	891ship, mail, sell or dispense specialty drugs into, within or from the commonwealth. The board
915	915	892shall ensure that all shipments of specialty pharmaceutical drugs from in-state pharmacies to out-
916	916	893of-state destinations comply with the licensing procedures applicable to pharmacies in the
917	917	894commonwealth.
918	918	895 (b) A specialty pharmacy shall designate a manager of record who shall disclose to the
919	919	896board the location, name and title of all principal managers and the name and Massachusetts
920	920	897license number of the designated manager of record annually and within 30 days after any
921	921	898change of office, corporate office or manager of record.
922	922	899 (c) The board shall: (i) adopt written policies or procedures or promulgate regulations
923	923	900that the board determines are necessary to implement this section; and (ii) establish standards for
924	924	901special handling, administration, quality, safety, and monitoring of specialty drugs; provided,
925	925	902however, that the board shall define the term “specialty drug” for the purposes of this section;
926	926	903and provided further, that the board shall consult with industry leaders and experts and shall base
927	927	904said policies, procedures or regulations on best evidence-based practices. 43 of 100
928	928	905 SECTION 44. Chapter 118E of the General Laws is hereby amended by inserting after
929	929	906section 10Q the following section:-
930	930	907 Section 10R. (a) As used in this section, the following words shall have the following
931	931	908meanings unless the context clearly requires otherwise:
932	932	909 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
933	933	910drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
934	934	911application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
935	935	912is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
936	936	913Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
937	937	914application that was approved by the United States Secretary of Health and Human Services
938	938	915under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
939	939	916date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
940	940	9171984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
941	941	918C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
942	942	919under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
943	943	920based on available data resources such as Medi-Span.
944	944	921 “Continuous glucose monitoring system”, a system to continuously sense, transmit and
945	945	922display blood glucose levels.
946	946	923 “Continuous glucose monitoring system component”, a component of a system to
947	947	924continuously monitor blood glucose levels such as a sensor, transmitter or display.
948	948	925 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
949	949	926drug; and (ii) an individual can obtain with a prescription. 44 of 100
950	950	927 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not
951	951	928limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home
952	952	929use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips,
953	953	930lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose
954	954	931monitors for use by the legally blind and visual magnifying aids for use by the legally blind;
955	955	932provided, however, that diabetes treatment supplies shall not include a brand name drug, a
956	956	933generic drug, a continuous glucose monitoring system component or a delivery device.
957	957	934 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
958	958	935abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
959	959	936drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
960	960	937and was not originally marketed under a new drug application; or (iv) identified by the health
961	961	938benefit plan as a generic drug based on available data resources such as Medi-Span.
962	962	939 “Separate delivery device”, a device that is used to deliver a brand name drug or a
963	963	940generic drug and that can be obtained with a prescription separate from, or in addition to, the
964	964	941brand name drug or generic drug that the device delivers.
965	965	942 (b) The division shall select 1 generic drug and 1 brand name drug used to treat each of
966	966	943the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart
967	967	944conditions that disproportionately impact a particular demographic group, including people of
968	968	945color, determined by the center for health information analysis; provided, however, that for
969	969	946diabetes, the division shall also select a continuous glucose monitoring system component.
970	970	947 The division shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
971	971	948brand name drug and 1 insulin generic drug, the division shall select 1 insulin brand name drug 45 of 100
972	972	949per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
973	973	950long-acting and premixed. To the extent possible, the division shall select 1 insulin generic drug
974	974	951per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
975	975	952long-acting and premixed, subject to the generic drug’s availability.
976	976	953 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when
977	977	954applicable, used to treat each chronic condition pursuant to subsection (b), the division shall
978	978	955select a drug that is among the top 3 of the division’s most prescribed or of the highest volume
979	979	956for the chronic condition and shall consider whether the drug is:
980	980	957 (i) of clear benefit and strongly supported by clinical evidence;
981	981	958 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
982	982	959exacerbations of illness progression or improve quality of life;
983	983	960 (iii) relatively low cost when compared to the cost of an acute illness or incident
984	984	961prevented or delayed by the use of the service, treatment or drug;
985	985	962 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
986	986	963 (v) likely to have a considerable financial impact on individual patients by reducing or
987	987	964eliminating patient cost-sharing pursuant to this section; and
988	988	965 (vi) likely to enhance equity in disproportionately impacted demographic groups,
989	989	966including people of color.
990	990	967 (d) The continuous glucose monitoring system component shall be selected in the same
991	991	968manner in which the 1 generic drug and 1 brand name drug are selected. 46 of 100
992	992	969 (e)(1) The division shall provide coverage for the brand name drugs and generic drugs
993	993	970selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject
994	994	971to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any
995	995	972deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
996	996	973insurance and any co-payment per 30-day supply shall not exceed the amount established in the
997	997	974fourth paragraph of subsection (5) of section 25, regardless of whether the beneficiary is enrolled
998	998	975in managed care; provided, however, that nothing in this section shall prevent co-payments for a
999	999	97630-day supply of the selected brand name drugs from being reduced below the amount specified
1000	1000	977in this section.
1001	1001	978 (2) If use of a brand name drug or generic drug that the division selects requires a
1002	1002	979separate delivery device, the division shall select a delivery device for that drug in accordance
1003	1003	980with the criteria established in subsection (c) for selecting brand name drugs and generic drugs,
1004	1004	981to the extent possible. The division shall provide coverage for the delivery device and the
1005	1005	982delivery device shall not be subject to any cost-sharing, including co-payments and co-insurance,
1006	1006	983and shall not be subject to any deductible.
1007	1007	984 (3) The division shall provide coverage for the continuous glucose monitoring system
1008	1008	985component selected pursuant to subsection (b) and all components of the blood glucose
1009	1009	986monitoring system of which the selected component is a part. All components of the applicable
1010	1010	987continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1011	1011	988payments and co-insurance, and shall not be subject to any deductible. 47 of 100
1012	1012	989 (4) The division shall provide coverage for necessary diabetes treatment supplies. Such
1013	1013	990supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1014	1014	991shall not be subject to any deductible.
1015	1015	992 (f) An enrollee and their prescribing health care provider shall have access to a clear,
1016	1016	993readily accessible and convenient process to request to use a different brand name drug or
1017	1017	994generic drug of the same pharmacological class in place of a brand name drug or generic drug
1018	1018	995selected under subsection (b). Such request for an exception shall be granted if: (i) the brand
1019	1019	996name drugs and generic drugs selected under subsection (b) are contraindicated or will likely
1020	1020	997cause an adverse reaction in or physical or mental harm to the enrollee; (ii) the brand name drugs
1021	1021	998and generic drugs selected under subsection (b) are expected to be ineffective based on the
1022	1022	999known clinical characteristics of the enrollee and the known characteristics of the prescription
1023	1023	1000drug regimen; (iii) the member or prescribing health care provider: (A) has provided
1024	1024	1001documentation to the division establishing that the enrollee has previously tried the brand name
1025	1025	1002drugs and generic drugs selected under subsection (b) while covered by the division or by a
1026	1026	1003previous health insurance carrier or a health benefit plan; and (B) such prescription drug was
1027	1027	1004discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or
1028	1028	1005(iv) the enrollee or prescribing health care provider has provided documentation to the division
1029	1029	1006establishing that the enrollee: (A) is stable on a prescription drug prescribed by the health care
1030	1030	1007provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental
1031	1031	1008harm to the enrollee. This subsection shall apply to continuous glucose monitoring system
1032	1032	1009components and, when applicable, delivery devices.
1033	1033	1010 (g) This section shall not apply to health plans providing coverage in the Senior Care
1034	1034	1011Options program to MassHealth-only members who are ages 65 and older. 48 of 100
1035	1035	1012 (h) The division shall implement a continuity of coverage policy for enrollees that are
1036	1036	1013new to the Medicaid program, which shall provide coverage for a 90-day fill of a United States
1037	1037	1014Food and Drug Administration-approved drug reimbursed through a pharmacy benefit that the
1038	1038	1015member has already been prescribed and on which the member is stable, upon documentation by
1039	1039	1016the member’s prescriber, and which was selected by the member’s previous payer pursuant to
1040	1040	1017subsection (b); provided, however, that the division shall not apply any greater deductible,
1041	1041	1018coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1042	1042	1019covered by the plan; and provided further, that the division shall provide a member or their
1043	1043	1020prescribing health care provider with information regarding the request pursuant to subsection (f)
1044	1044	1021within 30 days of a member or their health care provider contacting the division to use a different
1045	1045	1022brand name drug or generic drug of the same pharmacological class as the drugs selected
1046	1046	1023pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system
1047	1047	1024components and, when applicable, delivery devices.
1048	1048	1025 (i) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1049	1049	1026coverage pursuant to subsection (h), the division shall provide coverage for the prescription drug,
1050	1050	1027continuous glucose monitoring system component or delivery device prescribed by the member’s
1051	1051	1028health care provider at the same cost as required under subsection (e). A denial of an exception
1052	1052	1029shall be eligible for appeal by a member.
1053	1053	1030 (j) The division shall grant or deny a request pursuant to subsection (f) or (h) not more
1054	1054	1031than 3 business days following the receipt of all necessary information to establish the medical
1055	1055	1032necessity of the prescribed treatment; provided, however, that if additional delay would result in
1056	1056	1033significant risk to the member’s health or well-being, the division shall respond not more than 24
1057	1057	1034hours following the receipt of all necessary information to establish the medical necessity of the 49 of 100
1058	1058	1035prescribed treatment. If a response by the division is not received within the time required under
1059	1059	1036this subsection, an exception shall be deemed granted.
1060	1060	1037 (k) The division shall make changes in selected drugs not more than once annually and
1061	1061	1038shall provide notice to the division of insurance not less than 90 days before making changes to
1062	1062	1039the selected drugs and an explanation of such changes. Upon verification by the division of
1063	1063	1040insurance that the selected drugs meet the criteria identified in subsection (c), the division shall
1064	1064	1041provide notice to its enrollees not less than 30 days before any changes to the selected drugs are
1065	1065	1042made. This subsection shall apply to continuous glucose monitoring system components and,
1066	1066	1043when applicable, delivery devices in the same manner in which it applies to drugs.
1067	1067	1044 (l) The division shall make public the drugs, continuous glucose monitoring system
1068	1068	1045components, all components of the system of which the component is a part and delivery devices
1069	1069	1046selected pursuant to this section.
1070	1070	1047 (m) If a high deductible health plan subject to this section is used to establish a savings
1071	1071	1048account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1072	1072	1049section shall apply to the plan to the maximum extent possible without causing the account to
1073	1073	1050lose its tax-exempt status.
1074	1074	1051 SECTION 45. Chapter 175 of the General Laws is hereby amended by inserting after
1075	1075	1052section 47TT the following section:-
1076	1076	1053 Section 47UU. (a) As used in this section, the following words shall have the following
1077	1077	1054meanings unless the context clearly requires otherwise: 50 of 100
1078	1078	1055 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1079	1079	1056drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1080	1080	1057application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
1081	1081	1058is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1082	1082	1059Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1083	1083	1060application that was approved by the United States Secretary of Health and Human Services
1084	1084	1061under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1085	1085	1062date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
1086	1086	10631984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
1087	1087	1064C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
1088	1088	1065under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
1089	1089	1066based on available data resources such as Medi-Span.
1090	1090	1067 “Continuous glucose monitoring system”, a system to continuously sense, transmit and
1091	1091	1068display blood glucose levels.
1092	1092	1069 “Continuous glucose monitoring system component”, a component of a system to
1093	1093	1070continuously monitor blood glucose levels such as a sensor, transmitter or display.
1094	1094	1071 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1095	1095	1072drug; and (ii) an individual can obtain with a prescription.
1096	1096	1073 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not
1097	1097	1074limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home
1098	1098	1075use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips,
1099	1099	1076lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose 51 of 100
1100	1100	1077monitors for use by the legally blind and visual magnifying aids for use by the legally blind;
1101	1101	1078provided, however, that diabetes treatment supplies shall not include a brand name drug, a
1102	1102	1079generic drug, a continuous glucose monitoring system component or a delivery device.
1103	1103	1080 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1104	1104	1081abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1105	1105	1082drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1106	1106	1083and was not originally marketed under a new drug application; or (iv) identified by the health
1107	1107	1084benefit plan as a generic drug based on available data resources such as Medi-Span.
1108	1108	1085 “Separate delivery device”, a device that is used to deliver a brand name drug or a
1109	1109	1086generic drug and that can be obtained with a prescription separate from, or in addition to, the
1110	1110	1087brand name drug or generic drug that the device delivers.
1111	1111	1088 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1112	1112	1089chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1113	1113	1090chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart conditions that
1114	1114	1091disproportionately impact a particular demographic group, including people of color, determined
1115	1115	1092by the center for health information analysis; provided, however, that for diabetes, the carrier
1116	1116	1093shall also select a continuous glucose monitoring system component.
1117	1117	1094 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1118	1118	1095brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per
1119	1119	1096dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
1120	1120	1097long-acting and premixed. To the extent possible, the carrier shall select 1 insulin generic drug 52 of 100
1121	1121	1098per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
1122	1122	1099long-acting and premixed, subject to such generic drug’s availability.
1123	1123	1100 (c) In selecting the1 generic drug, the 1 brand name drug and the delivery device, when
1124	1124	1101applicable, used to treat each chronic condition pursuant to subsection (b), the carrier shall select
1125	1125	1102a drug that is among the top 3 of the carrier’s most prescribed or of the highest volume for the
1126	1126	1103chronic condition, and shall consider whether the drug is:
1127	1127	1104 (i) of clear benefit and strongly supported by clinical evidence;
1128	1128	1105 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1129	1129	1106exacerbations of illness progression or improve quality of life;
1130	1130	1107 (iii) relatively low cost when compared to the cost of an acute illness or incident
1131	1131	1108prevented or delayed by the use of the service, treatment or drug;
1132	1132	1109 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1133	1133	1110 (v) likely to have a considerable financial impact on individual patients by reducing or
1134	1134	1111eliminating patient cost-sharing pursuant to this section; and
1135	1135	1112 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1136	1136	1113including people of color.
1137	1137	1114 (d) The continuous glucose monitoring system component shall be selected in the same
1138	1138	1115manner in which the 1 generic drug and 1 brand name drug are selected.
1139	1139	1116 (e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs
1140	1140	1117selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject 53 of 100
1141	1141	1118to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any
1142	1142	1119deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
1143	1143	1120insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that
1144	1144	1121nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name
1145	1145	1122drugs from being reduced below the amount specified in this section.
1146	1146	1123 (2) If use of a brand name drug or generic drug that the carrier selects requires a separate
1147	1147	1124delivery device, the carrier shall select a delivery device for that drug in accordance with the
1148	1148	1125criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the
1149	1149	1126extent possible. The carrier shall provide coverage for the delivery device and the delivery
1150	1150	1127device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1151	1151	1128shall not be subject to any deductible.
1152	1152	1129 (3) The carrier shall provide coverage for the continuous glucose monitoring system
1153	1153	1130component selected pursuant to subsection (b) and all components of the blood glucose
1154	1154	1131monitoring system of which the selected component is a part. All components of the applicable
1155	1155	1132continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1156	1156	1133payments and co-insurance, and shall not be subject to any deductible.
1157	1157	1134 (4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such
1158	1158	1135supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1159	1159	1136shall not be subject to any deductible.
1160	1160	1137 (f) A member and their prescribing health care provider shall have access to a clear,
1161	1161	1138readily accessible and convenient process to request to use a different brand name drug or
1162	1162	1139generic drug of the same pharmacological class in place of a brand name drug or generic drug 54 of 100
1163	1163	1140selected under subsection (b). Such request for an exception shall be granted if: (i) the brand
1164	1164	1141name drugs and generic drugs selected under subsection (b) are contraindicated or will likely
1165	1165	1142cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name drugs
1166	1166	1143and generic drugs selected under subsection (b) are expected to be ineffective based on the
1167	1167	1144known clinical characteristics of the member and the known characteristics of the prescription
1168	1168	1145drug regimen; (iii) the member or prescribing health care provider: (A) has provided
1169	1169	1146documentation to the carrier establishing that the member has previously tried the brand name
1170	1170	1147drugs and generic drugs selected under subsection (b) ; and (B) such prescription drug was
1171	1171	1148discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or
1172	1172	1149(iv) the member or prescribing health care provider has provided documentation to the carrier
1173	1173	1150establishing that the member: (A) is stable on a prescription drug prescribed by the health care
1174	1174	1151provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental
1175	1175	1152harm to the member. This subsection shall apply to continuous glucose monitoring system
1176	1176	1153components and, when applicable, delivery devices.
1177	1177	1154 (g) The carrier shall implement a continuity of coverage policy for members that are new
1178	1178	1155to the carrier, which shall provide coverage for a 90-day fill of a United States Food and Drug
1179	1179	1156Administration-approved drug reimbursed through a pharmacy benefit that the member has
1180	1180	1157already been prescribed and on which the member is stable, upon documentation by the
1181	1181	1158member’s prescriber, and which was selected by the member’s previous payer pursuant to
1182	1182	1159subsection (b); provided, however, that a carrier shall not apply any greater deductible,
1183	1183	1160coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1184	1184	1161covered by the plan; and provided further, that the carrier shall provide a member or their
1185	1185	1162prescribing health care provider with information regarding the request pursuant to subsection (f) 55 of 100
1186	1186	1163within 30 days of a member or their health care provider contacting the carrier to use a different
1187	1187	1164brand name drug or generic drug of the same pharmacological class as the drugs selected
1188	1188	1165pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system
1189	1189	1166components and, when applicable, delivery devices.
1190	1190	1167 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1191	1191	1168coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug,
1192	1192	1169continuous glucose monitoring system component or delivery device prescribed by the member’s
1193	1193	1170health care provider at the same cost as required under subsection (e). A denial of an exception
1194	1194	1171shall be eligible for appeal by a member.
1195	1195	1172 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
1196	1196	11733 business days following the receipt of all necessary information to establish the medical
1197	1197	1174necessity of the prescribed treatment; provided, however, that if additional delay would result in
1198	1198	1175significant risk to the member’s health or well-being, the carrier shall respond not more than 24
1199	1199	1176hours following the receipt of all necessary information to establish the medical necessity of the
1200	1200	1177prescribed treatment. If a response by the carrier is not received within the time required under
1201	1201	1178this subsection, an exception shall be deemed granted.
1202	1202	1179 (j) The carrier shall make changes in selected drugs not more than once annually and
1203	1203	1180shall provide notice to the division of insurance not less than 90 days before making changes to
1204	1204	1181the selected drugs and an explanation of such changes. Upon verification by the division of
1205	1205	1182insurance that the selected drugs meet the criteria identified in subsection (c), the carrier shall
1206	1206	1183provide notice to its members not less than 30 days before any changes to the selected drugs are 56 of 100
1207	1207	1184made. This subsection shall apply to continuous glucose monitoring system components and,
1208	1208	1185when applicable, delivery devices in the same manner in which it applies to drugs.
1209	1209	1186 (k) The carrier shall make public the drugs, continuous glucose monitoring system
1210	1210	1187components, all components of the system of which the component is a part and delivery devices
1211	1211	1188selected pursuant to this section.
1212	1212	1189 (l) If a high deductible health plan subject to this section is used to establish a savings
1213	1213	1190account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1214	1214	1191section shall apply to the plan to the maximum extent possible without causing the account to
1215	1215	1192lose its tax-exempt status.
1216	1216	1193 SECTION 45A. Said chapter 175 of the General Laws is hereby further amended by
1217	1217	1194inserting after section 47UU, inserted by section 45, the following section:-
1218	1218	1195 Section 47VV. (a) As used in this section, the following words shall have the following
1219	1219	1196meanings unless the context clearly requires otherwise:
1220	1220	1197 “340B drug”, a drug that has been subject to any offer for reduced prices by a
1221	1221	1198manufacturer pursuant to 42 U.S.C. 256b and is purchased by a 340B grantee as defined in this
1222	1222	1199section.
1223	1223	1200 “340B grantee”, a federally qualified health center, a non-state, government public safety
1224	1224	1201net hospital system established pursuant to chapter 147 of the acts of 1996 or a non-profit acute
1225	1225	1202care hospital in the commonwealth that received not less than 60 per cent of its gross patient
1226	1226	1203service revenue in fiscal year 2021 from government payers, including Medicare, MassHealth
1227	1227	1204and the Health Safety Net Trust Fund based on the hospital’s fiscal year 2021 cost report and that 57 of 100
1228	1228	1205is also authorized to participate in the federal drug discount program under 42 U.S.C 256b,
1229	1229	1206including its pharmacies or any contracted pharmacy.
1230	1230	1207 “Distributor”, a person engaged in the sale, distribution or delivery, at wholesale, of
1231	1231	1208drugs or medicines within the commonwealth, including entities operating outside of the
1232	1232	1209commonwealth that cause deliveries of drugs or medicines to be made within the
1233	1233	1210commonwealth.
1234	1234	1211 “Federally qualified health center”, an entity receiving a grant under 42 U.S.C. 254(b).
1235	1235	1212 “Manufacturer”, an entity engaged in the production, preparation, propagation,
1236	1236	1213compounding, conversion or processing of prescription drugs or medical devices, either directly
1237	1237	1214or indirectly, by extraction from substances of natural origin, or independently by means of
1238	1238	1215chemical synthesis or by a combination of extraction and chemical synthesis, or any entity
1239	1239	1216engaged in the packaging, repackaging, labeling, relabeling or distribution of prescription drugs.
1240	1240	1217 “Pharmacy”, an entity engaged in the drug business, as defined in section 37 of chapter
1241	1241	1218112, or engaged in the practice of compounding to fulfill a practitioner prescription.
1242	1242	1219 (b) A manufacturer or distributor shall not:
1243	1243	1220 (i) deny, restrict, prohibit, or otherwise interfere with, either directly or indirectly, the
1244	1244	1221acquisition of a 340B drug by, or delivery of a 340B drug to, a pharmacy that is under contract
1245	1245	1222with a 340B grantee and is authorized under such contract to receive and dispense 340B drugs on
1246	1246	1223behalf of the covered entity unless such receipt is prohibited by the United States Department of
1247	1247	1224Health and Human Services; or
1248	1248	1225 (ii) interfere with a contract between a pharmacy and a 340B grantee. 58 of 100
1249	1249	1226 (c) The commission of any act prohibited under subsection (b) of this section shall
1250	1250	1227constitute an unfair or deceptive practice within the meaning of section 2 of chapter 93A. Each
1251	1251	1228commission of a prohibited act shall constitute a separate violation.
1252	1252	1229 (d) The attorney general shall have jurisdiction, consistent with the provisions of chapter
1253	1253	123093A, to enforce the provisions of this section. The attorney general shall issue regulations to
1254	1254	1231implement this chapter.
1255	1255	1232 (e) The board of registration in pharmacy shall promulgate regulations to implement and
1256	1256	1233enforce of this section and may investigate any complaint of a violation of this section by an
1257	1257	1234individual or entity licensed by the board and may impose discipline, suspension or revocation of
1258	1258	1235any such license.
1259	1259	1236 (f) Nothing in this section shall be construed or applied to be less restrictive than any
1260	1260	1237federal law as to any person or entity regulated by this section or to conflict with: (i) any
1261	1261	1238applicable federal law and related regulations; or (ii) any other general law that is compatible
1262	1262	1239with applicable federal law.
1263	1263	1240 (g) Limited distribution of a drug required under 21 U.S.C. 355-1 shall not be a violation
1264	1264	1241of this section.
1265	1265	1242 SECTION 46. Section 226 of said chapter 175, as appearing in the 2022 Official Edition,
1266	1266	1243is hereby amended by striking out subsection (a) and inserting in place thereof the following
1267	1267	1244subsection:-
1268	1268	1245 (a) For the purposes of this section, the term “pharmacy benefit manager” shall mean a
1269	1269	1246person, business or other entity, however organized, that directly or through a subsidiary 59 of 100
1270	1270	1247provides pharmacy benefit management services for prescription drugs and devices on behalf of
1271	1271	1248a health benefit plan sponsor, including, but not limited to, a self-insurance plan, labor union or
1272	1272	1249other third-party payer; provided, however, that pharmacy benefit management services shall
1273	1273	1250include, but not be limited to: (i) the processing and payment of claims for prescription drugs;
1274	1274	1251(ii) the performance of drug utilization review; (iii) the processing of drug prior authorization
1275	1275	1252requests; (iv) pharmacy contracting; (v) the adjudication of appeals or grievances related to
1276	1276	1253prescription drug coverage contracts; (vi) formulary administration; (vii) drug benefit design;
1277	1277	1254(viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) clinical, safety and
1278	1278	1255adherence programs for pharmacy services; and (xi) managing the cost of covered prescription
1279	1279	1256drugs; provided further, that “pharmacy benefit manager” shall include a health benefit plan
1280	1280	1257sponsor that does not contract with a pharmacy benefit manager and manages its own
1281	1281	1258prescription drug benefits unless specifically exempted.
1282	1282	1259 SECTION 47. Chapter 176A of the General Laws is hereby amended by inserting after
1283	1283	1260section 8UU the following section:-
1284	1284	1261 Section 8VV. (a) As used in this section, the following words shall have the following
1285	1285	1262meanings unless the context clearly requires otherwise:
1286	1286	1263 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1287	1287	1264drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1288	1288	1265application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
1289	1289	1266is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1290	1290	1267Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1291	1291	1268application that was approved by the United States Secretary of Health and Human Services 60 of 100
1292	1292	1269under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1293	1293	1270date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
1294	1294	12711984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
1295	1295	1272C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
1296	1296	1273under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
1297	1297	1274based on available data resources such as Medi-Span.
1298	1298	1275 “Continuous glucose monitoring system”, a system to continuously sense, transmit and
1299	1299	1276display blood glucose levels.
1300	1300	1277 “Continuous glucose monitoring system component”, a component of a system to
1301	1301	1278continuously monitor blood glucose levels such as a sensor, transmitter or display.
1302	1302	1279 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1303	1303	1280drug; and (ii) an individual can obtain with a prescription.
1304	1304	1281 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not
1305	1305	1282limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home
1306	1306	1283use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips,
1307	1307	1284lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose
1308	1308	1285monitors for use by the legally blind and visual magnifying aids for use by the legally blind;
1309	1309	1286provided, however, that diabetes treatment supplies shall not include a brand name drug, a
1310	1310	1287generic drug, a continuous glucose monitoring system component, or a delivery device.
1311	1311	1288 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1312	1312	1289abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1313	1313	1290drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962 61 of 100
1314	1314	1291and was not originally marketed under a new drug application; or (iv) identified by the health
1315	1315	1292benefit plan as a generic drug based on available data resources such as Medi-Span.
1316	1316	1293 “Separate delivery device”, a device that is used to deliver a brand name drug or a
1317	1317	1294generic drug and that can be obtained with a prescription separate from, or in addition to, the
1318	1318	1295brand name drug or generic drug that the device delivers.
1319	1319	1296 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1320	1320	1297chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1321	1321	1298chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart conditions that
1322	1322	1299disproportionately impact a particular demographic group, including people of color, determined
1323	1323	1300by the center for health information analysis; provided, however, that for diabetes, the carrier
1324	1324	1301shall also select a continuous glucose monitoring system component.
1325	1325	1302 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1326	1326	1303brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per
1327	1327	1304dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
1328	1328	1305long-acting and premixed. To the extent possible, the carrier shall select 1 insulin generic drug
1329	1329	1306per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
1330	1330	1307long-acting and premixed, subject to such generic drug’s availability.
1331	1331	1308 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when
1332	1332	1309applicable, used to treat each chronic condition pursuant to subsection (b), the carrier shall select
1333	1333	1310a drug that is among the top 3 of the carrier’s most prescribed or of the highest volume for the
1334	1334	1311chronic condition and shall consider whether the drug is:
1335	1335	1312 (i) of clear benefit and strongly supported by clinical evidence; 62 of 100
1336	1336	1313 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1337	1337	1314exacerbations of illness progression or improve quality of life;
1338	1338	1315 (iii) relatively low cost when compared to the cost of an acute illness or incident
1339	1339	1316prevented or delayed by the use of the service, treatment or drug;
1340	1340	1317 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1341	1341	1318 (v) likely to have a considerable financial impact on individual patients by reducing or
1342	1342	1319eliminating patient cost-sharing pursuant to this section; and
1343	1343	1320 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1344	1344	1321including people of color.
1345	1345	1322 (d) The continuous glucose monitoring system component shall be selected in the same
1346	1346	1323manner in which the 1 generic drug and 1 brand name drug are selected.
1347	1347	1324 (e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs
1348	1348	1325selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject
1349	1349	1326to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any
1350	1350	1327deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
1351	1351	1328insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that
1352	1352	1329nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name
1353	1353	1330drugs from being reduced below the amount specified in this section.
1354	1354	1331 (2) If use of a brand name drug or generic drug that the carrier selects requires a separate
1355	1355	1332delivery device, the carrier shall select a delivery device for that drug in accordance with the
1356	1356	1333criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the 63 of 100
1357	1357	1334extent possible. The carrier shall provide coverage for the delivery device and the delivery
1358	1358	1335device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1359	1359	1336shall not be subject to any deductible.
1360	1360	1337 (3) The carrier shall provide coverage for the continuous glucose monitoring system
1361	1361	1338component selected pursuant to subsection (b) and all components of the blood glucose
1362	1362	1339monitoring system of which the selected component is a part. All components of the applicable
1363	1363	1340continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1364	1364	1341payments and co-insurance, and shall not be subject to any deductible.
1365	1365	1342 (4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such
1366	1366	1343supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1367	1367	1344shall not be subject to any deductible.
1368	1368	1345 (f) A member and their prescribing health care provider shall have access to a clear,
1369	1369	1346readily accessible and convenient process to request to use a different brand name drug or
1370	1370	1347generic drug of the same pharmacological class in place of a brand name drug or generic drug
1371	1371	1348selected under subsection (b). Such request for an exception shall be granted if: (i) the brand
1372	1372	1349name drugs and generic drugs selected under subsection (b) are contraindicated or will likely
1373	1373	1350cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name drugs
1374	1374	1351and generic drugs selected under said subsection (b) are expected to be ineffective based on the
1375	1375	1352known clinical characteristics of the member and the known characteristics of the prescription
1376	1376	1353drug regimen; (iii) the member or prescribing health care provider: (A) has provided
1377	1377	1354documentation to the carrier establishing that the member has previously tried the brand name
1378	1378	1355drugs and generic drugs selected under subsection (b) ; and (B) such prescription drug was 64 of 100
1379	1379	1356discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or
1380	1380	1357(iv) the member or prescribing health care provider has provided documentation to the carrier
1381	1381	1358establishing that the member: (A) is stable on a prescription drug prescribed by the health care
1382	1382	1359provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental
1383	1383	1360harm to the member. This subsection shall apply to continuous glucose monitoring system
1384	1384	1361components and, when applicable, delivery devices.
1385	1385	1362 (g) The carrier shall implement a continuity of coverage policy for members that are new
1386	1386	1363to the carrier, which shall provide coverage for a 90-day fill of a United States Food and Drug
1387	1387	1364Administration-approved drug reimbursed through a pharmacy benefit that the member has
1388	1388	1365already been prescribed and on which the member is stable, upon documentation by the
1389	1389	1366member’s prescriber, and which was selected by the member’s previous payer pursuant to
1390	1390	1367subsection (b); provided, however, that a carrier shall not apply any greater deductible,
1391	1391	1368coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1392	1392	1369covered by the plan; and provided further, that the carrier shall provide a member or their
1393	1393	1370prescribing health care provider with information regarding the request pursuant to subsection (f)
1394	1394	1371within 30 days of a member or their health care provider contacting the carrier to use a different
1395	1395	1372brand name drug or generic drug of the same pharmacological class as the drugs selected
1396	1396	1373pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system
1397	1397	1374components and, when applicable, delivery devices.
1398	1398	1375 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1399	1399	1376coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug,
1400	1400	1377continuous glucose monitoring system component or delivery device prescribed by the member’s 65 of 100
1401	1401	1378health care provider at the same cost as required under subsection (e). A denial of an exception
1402	1402	1379shall be eligible for appeal by a member.
1403	1403	1380 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
1404	1404	13813 business days following the receipt of all necessary information to establish the medical
1405	1405	1382necessity of the prescribed treatment; provided, however, that if additional delay would result in
1406	1406	1383significant risk to the member’s health or well-being, the carrier shall respond not more than 24
1407	1407	1384hours following the receipt of all necessary information to establish the medical necessity of the
1408	1408	1385prescribed treatment. If a response by the carrier is not received within the time required under
1409	1409	1386this subsection, an exception shall be deemed granted.
1410	1410	1387 (j) The carrier shall make changes in selected drugs not more than once annually and
1411	1411	1388shall provide notice to the division of insurance not less than 90 days before making changes to
1412	1412	1389the selected drugs and an explanation of such changes. Upon verification by the division of
1413	1413	1390insurance that the selected drugs meet the criteria identified in suIction (c), the carrier shall
1414	1414	1391provide notice to its members not less than 30 days before any changes to the selected drugs are
1415	1415	1392made. This subsection shall apply to continuous glucose monitoring system components and,
1416	1416	1393when applicable, delivery devices in the same manner in which it applies to drugs.
1417	1417	1394 (k) The carrier shall make public the drugs, continuous glucose monitoring system
1418	1418	1395components, all components of the system of which the component is a part and delivery devices
1419	1419	1396selected pursuant to this section.
1420	1420	1397 (l) If a high deductible health plan subject to this section is used to establish a savings
1421	1421	1398account that is tax-exempt under the federal Internal Revenue Code, the provisions of this 66 of 100
1422	1422	1399section shall apply to the plan to the maximum extent possible without causing the account to
1423	1423	1400lose its tax-exempt status.
1424	1424	1401 SECTION 48. Chapter 176B of the General Laws is hereby amended by inserting after
1425	1425	1402section 4UU the following section:-
1426	1426	1403 Section 4VV. (a) As used in this section, the following words shall have the following
1427	1427	1404meanings unless the context clearly requires otherwise:
1428	1428	1405 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1429	1429	1406drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1430	1430	1407application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
1431	1431	1408is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1432	1432	1409Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1433	1433	1410application that was approved by the United States Secretary of Health and Human Services
1434	1434	1411under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1435	1435	1412date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
1436	1436	14131984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
1437	1437	1414C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
1438	1438	1415under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
1439	1439	1416based on available data resources such as Medi-Span.
1440	1440	1417 “Continuous glucose monitoring system”, a system to continuously sense, transmit and
1441	1441	1418display blood glucose levels.
1442	1442	1419 “Continuous glucose monitoring system component”, a component of a system to
1443	1443	1420continuously monitor blood glucose levels such as a sensor, transmitter or display. 67 of 100
1444	1444	1421 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1445	1445	1422drug; and (ii) an individual can obtain with a prescription.
1446	1446	1423 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not
1447	1447	1424limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home
1448	1448	1425use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips,
1449	1449	1426lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose
1450	1450	1427monitors for use by the legally blind and visual magnifying aids for use by the legally blind;
1451	1451	1428provided, however, that diabetes treatment supplies shall not include a brand name drug, a
1452	1452	1429generic drug, a continuous glucose monitoring system component or a delivery device.
1453	1453	1430 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1454	1454	1431abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1455	1455	1432drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1456	1456	1433and was not originally marketed under a new drug application; or (iv) identified by the health
1457	1457	1434benefit plan as a generic drug based on available data resources such as Medi-Span.
1458	1458	1435 “Separate delivery device”, a device that is used to deliver a brand name drug or a
1459	1459	1436generic drug and that can be obtained with a prescription separate from, or in addition to, the
1460	1460	1437brand name drug or generic drug that the device delivers.
1461	1461	1438 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1462	1462	1439chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1463	1463	1440chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart conditions that
1464	1464	1441disproportionately impact a particular demographic group, including people of color, determined 68 of 100
1465	1465	1442by the center for health information analysis; provided, however, that for diabetes, the carrier
1466	1466	1443shall also select a continuous glucose monitoring system component.
1467	1467	1444 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1468	1468	1445brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per
1469	1469	1446dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
1470	1470	1447long-acting and premixed. To the extent possible, the carrier shall select 1 insulin generic drug
1471	1471	1448per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
1472	1472	1449long-acting and premixed, subject to such generic drug’s availability.
1473	1473	1450 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when
1474	1474	1451applicable, used to treat each chronic condition pursuant to subsection (b), the carrier shall select
1475	1475	1452a drug that is among the top 3 of the carrier’s most prescribed or of the highest volume for the
1476	1476	1453chronic condition, and shall consider whether the drug is:
1477	1477	1454 (i) of clear benefit and strongly supported by clinical evidence;
1478	1478	1455 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1479	1479	1456exacerbations of illness progression or improve quality of life;
1480	1480	1457 (iii) relatively low cost when compared to the cost of an acute illness or incident
1481	1481	1458prevented or delayed by the use of the service, treatment or drug;
1482	1482	1459 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1483	1483	1460 (v) likely to have a considerable financial impact on individual patients by reducing or
1484	1484	1461eliminating patient cost-sharing pursuant to this section; and 69 of 100
1485	1485	1462 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1486	1486	1463including people of color.
1487	1487	1464 (d) The continuous glucose monitoring system component shall be selected in the same
1488	1488	1465manner in which the 1 generic drug and 1 brand name drug are selected.
1489	1489	1466 (e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs
1490	1490	1467selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject
1491	1491	1468to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any
1492	1492	1469deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
1493	1493	1470insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that
1494	1494	1471nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name
1495	1495	1472drugs from being reduced below the amount specified in this section.
1496	1496	1473 (2) If use of a brand name drug or generic drug that the carrier selects requires a separate
1497	1497	1474delivery device, the carrier shall select a delivery device for that drug in accordance with the
1498	1498	1475criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the
1499	1499	1476extent possible. The carrier shall provide coverage for the delivery device and the delivery
1500	1500	1477device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1501	1501	1478shall not be subject to any deductible.
1502	1502	1479 (3) The carrier shall provide coverage for the continuous glucose monitoring system
1503	1503	1480component selected pursuant to subsection (b) and all components of the blood glucose
1504	1504	1481monitoring system of which the selected component is a part. All components of the applicable
1505	1505	1482continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1506	1506	1483payments and co-insurance, and shall not be subject to any deductible. 70 of 100
1507	1507	1484 (4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such
1508	1508	1485supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1509	1509	1486shall not be subject to any deductible.
1510	1510	1487 (f) A member and their prescribing health care provider shall have access to a clear,
1511	1511	1488readily accessible and convenient process to request to use a different brand name drug or
1512	1512	1489generic drug of the same pharmacological class in place of a brand name drug or generic drug
1513	1513	1490selected under subsection (b). Such request for an exception shall be granted if: (i) the brand
1514	1514	1491name drugs and generic drugs selected under said subsection (b) are contraindicated or will
1515	1515	1492likely cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name
1516	1516	1493drugs and generic drugs selected under said subsection (b) are expected to be ineffective based
1517	1517	1494on the known clinical characteristics of the member and the known characteristics of the
1518	1518	1495prescription drug regimen; (iii) the member or prescribing health care provider: (A) has provided
1519	1519	1496documentation to the carrier establishing that the member has previously tried the brand name
1520	1520	1497drugs and generic drugs selected under said subsection (b) while covered by the carrier or by a
1521	1521	1498previous health insurance carrier or a health benefit plan; and (B) such prescription drug was
1522	1522	1499discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or
1523	1523	1500(iv) the member or prescribing health care provider has provided documentation to the carrier
1524	1524	1501establishing that the member: (A) is stable on a prescription drug prescribed by the health care
1525	1525	1502provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental
1526	1526	1503harm to the member. This subsection shall apply to continuous glucose monitoring system
1527	1527	1504components and, when applicable, delivery devices.
1528	1528	1505 (g) The carrier shall implement a continuity of coverage policy for members that are new
1529	1529	1506to the carrier, which shall provide coverage for a 90-day fill of a United States Food and Drug 71 of 100
1530	1530	1507Administration-approved drug reimbursed through a pharmacy benefit that the member has
1531	1531	1508already been prescribed and on which the member is stable, upon documentation by the
1532	1532	1509member’s prescriber, and which was selected by the member’s previous payer pursuant to
1533	1533	1510subsection (b); provided, however, that a carrier shall not apply any greater deductible,
1534	1534	1511coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1535	1535	1512covered by the plan; and provided further, that the carrier shall provide a member or their
1536	1536	1513prescribing health care provider with information regarding the request pursuant to subsection (f)
1537	1537	1514within 30 days of a member or their health care provider contacting the carrier to use a different
1538	1538	1515brand name drug or generic drug of the same pharmacological class as the drugs selected
1539	1539	1516pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system
1540	1540	1517components and, when applicable, delivery devices.
1541	1541	1518 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1542	1542	1519coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug,
1543	1543	1520continuous glucose monitoring system component or delivery device prescribed by the member’s
1544	1544	1521health care provider at the same cost as required under subsection (e). A denial of an exception
1545	1545	1522shall be eligible for appeal by a member.
1546	1546	1523 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
1547	1547	15243 business days following the receipt of all necessary information to establish the medical
1548	1548	1525necessity of the prescribed treatment; provided, however, that if additional delay would result in
1549	1549	1526significant risk to the member’s health or well-being, the carrier shall respond not more than 24
1550	1550	1527hours following the receipt of all necessary information to establish the medical necessity of the
1551	1551	1528prescribed treatment. If a response by the carrier is not received within the time required under
1552	1552	1529this subsection, an exception shall be deemed granted. 72 of 100
1553	1553	1530 (j) The carrier shall make changes in selected drugs not more than once annually and
1554	1554	1531shall provide notice to the division of insurance not less than 90 days before making such
1555	1555	1532changes to the selected drugs and an explanation of those changes. Upon verification by the
1556	1556	1533division of insurance that the selected drugs meet the criteria identified in subsection (c), the
1557	1557	1534carrier shall provide notice to its members not less than 30 days before any changes to the
1558	1558	1535selected drugs are made. This subsection shall apply to continuous glucose monitoring system
1559	1559	1536components and, when applicable, delivery devices in the same manner in which it applies to
1560	1560	1537drugs.
1561	1561	1538 (k) The carrier shall make public the drugs, continuous glucose monitoring system
1562	1562	1539components, all components of the system of which the component is a part and delivery devices
1563	1563	1540selected pursuant to this section.
1564	1564	1541 (l) If a high deductible health plan subject to this section is used to establish a savings
1565	1565	1542account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1566	1566	1543section shall apply to the plan to the maximum extent possible without causing the account to
1567	1567	1544lose its tax-exempt status.
1568	1568	1545 SECTION 49. The fourth paragraph of section 3B of chapter 176D of the General Laws,
1569	1569	1546as appearing in the 2022 Official Edition, is hereby amended by inserting after the second
1570	1570	1547sentence the following sentence:- Neither a carrier nor the group insurance commission may
1571	1571	1548prohibit the dispensing of a specialty drug that is included in its pharmaceutical drug benefits to
1572	1572	1549an insured by any network specialty pharmacy licensed under section 39K of chapter 112;
1573	1573	1550provided, however, that the pharmacy: (i) agrees to the in-network reimbursement rate for the
1574	1574	1551specialty drug; (ii) is able to comply with the standards for special handling, administration, 73 of 100
1575	1575	1552quality, safety and monitoring established under subsection (c) of said section 39K of said
1576	1576	1553chapter 112; and (iii) complies with all reasonable carrier network terms and conditions for
1577	1577	1554dispensing the specialty drug; provided further, that neither a carrier nor the group insurance
1578	1578	1555commission may impose any terms or conditions on a specialty pharmacy licensed under said
1579	1579	1556section 39K of said chapter 112 that are unreasonable or prevent the specialty pharmacy from
1580	1580	1557providing the specialty drug; provided further, that the commissioner may grant a waiver
1581	1581	1558exempting a carrier from the requirements of this sentence to a carrier whose percentage of
1582	1582	1559members enrolled in government programs is 80 per cent or more, as indicated in the most recent
1583	1583	1560enrollment data published by the center for health information and analysis; and provided
1584	1584	1561further, that for the purposes of this sentence, the term “carrier” shall apply to the division of
1585	1585	1562medical assistance to the extent allowed under federal law.
1586	1586	1563 SECTION 50. Said section 3B of said chapter 176D, as so appearing, is hereby further
1587	1587	1564amended by striking out the fifth paragraph and inserting in place thereof the following
1588	1588	1565paragraph:-
1589	1589	1566 A carrier shall not prohibit a network pharmacy from offering and providing mail
1590	1590	1567delivery services to an insured; provided, however, that the network pharmacy agrees to the
1591	1591	1568reimbursement terms and conditions and discloses to the insured any delivery service fee
1592	1592	1569associated with the delivery service.
1593	1593	1570 SECTION 51. The eighth paragraph of said section 3B of said chapter 176D, as so
1594	1594	1571appearing, is hereby amended by adding the following sentence:- The term “specialty drugs”
1595	1595	1572shall mean a specialty drug as defined under section 39K of chapter 112. 74 of 100
1596	1596	1573 SECTION 52. Chapter 176G of the General Laws is hereby amended by inserting after
1597	1597	1574section 4MM the following section:-
1598	1598	1575 Section 4NN. (a) As used in this section, the following words shall have the following
1599	1599	1576meanings unless the context clearly requires otherwise:
1600	1600	1577 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1601	1601	1578drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1602	1602	1579application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
1603	1603	1580is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1604	1604	1581Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1605	1605	1582application that was approved by the United States Secretary of Health and Human Services
1606	1606	1583under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1607	1607	1584date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
1608	1608	15851984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
1609	1609	1586C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
1610	1610	1587under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
1611	1611	1588based on available data resources such as Medi-Span.
1612	1612	1589 “Continuous glucose monitoring system”, a system to continuously sense, transmit and
1613	1613	1590display blood glucose levels.
1614	1614	1591 “Continuous glucose monitoring system component”, a component of a system to
1615	1615	1592continuously monitor blood glucose levels such as a sensor, transmitter or display.
1616	1616	1593 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1617	1617	1594drug; and (ii) an individual can obtain with a prescription. 75 of 100
1618	1618	1595 “Diabetes treatment supplies”, supplies for the treatment of diabetes including, but not
1619	1619	1596limited to, syringes, needles, blood glucose monitors, blood glucose monitoring strips for home
1620	1620	1597use, strips to calibrate continuous blood glucose monitors, urine glucose strips, ketone strips,
1621	1621	1598lancets, adhesive skin patches, insulin pump supplies, voice-synthesizers for blood glucose
1622	1622	1599monitors for use by the legally blind and visual magnifying aids for use by the legally blind;
1623	1623	1600provided, however, that diabetes treatment supplies shall not include a brand name drug, a
1624	1624	1601generic drug, a continuous glucose monitoring system component, or a delivery device.”
1625	1625	1602 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1626	1626	1603abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1627	1627	1604drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1628	1628	1605and was not originally marketed under a new drug application; or (iv) identified by the health
1629	1629	1606benefit plan as a generic drug based on available data resources such as Medi-Span.
1630	1630	1607 “Separate delivery device”, a device that is used to deliver a brand name drug or a
1631	1631	1608generic drug and that can be obtained with a prescription separate from, or in addition to, the
1632	1632	1609brand name drug or generic drug that the device delivers.
1633	1633	1610 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1634	1634	1611chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1635	1635	1612chronic conditions: (i) diabetes; (ii) asthma; and (iii) the 3 most prevalent heart conditions that
1636	1636	1613disproportionately impact a particular demographic group, including people of color, determined
1637	1637	1614by the center for health information analysis; provided, however, that for diabetes, the carrier
1638	1638	1615shall also select a continuous glucose monitoring system component. 76 of 100
1639	1639	1616 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1640	1640	1617brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per
1641	1641	1618dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
1642	1642	1619long-acting and premixed. To the extent possible, the carrier shall select 1 insulin generic drug
1643	1643	1620per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
1644	1644	1621long-acting and premixed, subject to such generic drug’s availability.
1645	1645	1622 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when
1646	1646	1623applicable, used to treat each chronic condition pursuant to subsection (b), the carrier shall select
1647	1647	1624a drug that is among the top 3 of the carrier’s most prescribed or of the highest volume for the
1648	1648	1625chronic condition, and shall consider whether the drug is:
1649	1649	1626 (i) of clear benefit and strongly supported by clinical evidence;
1650	1650	1627 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1651	1651	1628exacerbations of illness progression or improve quality of life;
1652	1652	1629 (iii) relatively low cost when compared to the cost of an acute illness or incident
1653	1653	1630prevented or delayed by the use of the service, treatment or drug;
1654	1654	1631 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1655	1655	1632 (v) likely to have a considerable financial impact on individual patients by reducing or
1656	1656	1633eliminating patient cost-sharing pursuant to this section; and
1657	1657	1634 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1658	1658	1635including people of color. 77 of 100
1659	1659	1636 (d) The continuous glucose monitoring system component shall be selected in the same
1660	1660	1637manner in which the 1 generic drug and 1 brand name drug are selected.
1661	1661	1638 (e)(1) The carrier shall provide coverage for the brand name drugs and generic drugs
1662	1662	1639selected pursuant to subsection (b). Coverage for the selected generic drugs shall not be subject
1663	1663	1640to any cost-sharing, including co-payments and co-insurance, and shall not be subject to any
1664	1664	1641deductible. Coverage for selected brand name drugs shall not be subject to any deductible or co-
1665	1665	1642insurance and any co-payment shall not exceed $25 per 30-day supply; provided, however, that
1666	1666	1643nothing in this section shall prevent co-payments for a 30-day supply of the selected brand name
1667	1667	1644drugs from being reduced below the amount specified in this section.
1668	1668	1645 (2) If use of a brand name drug or generic drug that the carrier selects requires a separate
1669	1669	1646delivery device, the carrier shall select a delivery device for that drug in accordance with the
1670	1670	1647criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the
1671	1671	1648extent possible. The carrier shall provide coverage for the delivery device and the delivery
1672	1672	1649device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1673	1673	1650shall not be subject to any deductible.
1674	1674	1651 (3) The carrier shall provide coverage for the continuous glucose monitoring system
1675	1675	1652component selected pursuant to subsection (b) and all components of the blood glucose
1676	1676	1653monitoring system of which the selected component is a part. All components of the applicable
1677	1677	1654continuous glucose monitoring system shall not be subject to any cost-sharing, including co-
1678	1678	1655payments and co-insurance, and shall not be subject to any deductible. 78 of 100
1679	1679	1656 (4) The carrier shall provide coverage for necessary diabetes treatment supplies. Such
1680	1680	1657supplies shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1681	1681	1658shall not be subject to any deductible.
1682	1682	1659 (f) A member and their prescribing health care provider shall have access to a clear,
1683	1683	1660readily accessible and convenient process to request to use a different brand name drug or
1684	1684	1661generic drug of the same pharmacological class in place of a brand name drug or generic drug
1685	1685	1662selected under subsection (b). Such request for an exception shall be granted if: (i) the brand
1686	1686	1663name drugs and generic drugs selected under said subsection (b) are contraindicated or will
1687	1687	1664likely cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name
1688	1688	1665drugs and generic drugs selected under said subsection (b) are expected to be ineffective based
1689	1689	1666on the known clinical characteristics of the member and the known characteristics of the
1690	1690	1667prescription drug regimen; (iii) the member or prescribing health care provider: (A) has provided
1691	1691	1668documentation to the carrier establishing that the member has previously tried the brand name
1692	1692	1669drugs and generic drugs selected under said subsection (b); and (B) such prescription drug was
1693	1693	1670discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or
1694	1694	1671(iv) the member or prescribing health care provider has provided documentation to the carrier
1695	1695	1672establishing that the member: (A) is stable on a prescription drug prescribed by the health care
1696	1696	1673provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental
1697	1697	1674harm to the member. This subsection shall apply to continuous glucose monitoring system
1698	1698	1675components and, when applicable, delivery devices.
1699	1699	1676 (g) The carrier shall implement a continuity of coverage policy for members that are new
1700	1700	1677to the carrier, which shall provide coverage for a 90-day fill of a United States Food and Drug
1701	1701	1678Administration-approved drug reimbursed through a pharmacy benefit that the member has 79 of 100
1702	1702	1679already been prescribed and on which the member is stable, upon documentation by the
1703	1703	1680member’s prescriber, and which was selected by the member’s previous payer pursuant to
1704	1704	1681subsection (b); provided, however, that a carrier shall not apply any greater deductible,
1705	1705	1682coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1706	1706	1683covered by the plan; and provided further, that the carrier shall provide a member or their
1707	1707	1684prescribing health care provider with information regarding the request pursuant to subsection (f)
1708	1708	1685within 30 days of a member or their health care provider contacting the carrier to use a different
1709	1709	1686brand name drug or generic drug of the same pharmacological class as the drugs selected
1710	1710	1687pursuant to subsection (b). This subsection shall apply to continuous glucose monitoring system
1711	1711	1688components and, when applicable, delivery devices.
1712	1712	1689 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1713	1713	1690coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug,
1714	1714	1691continuous glucose monitoring system component or delivery device prescribed by the member’s
1715	1715	1692health care provider at the same cost as required under subsection (e). A denial of an exception
1716	1716	1693shall be eligible for appeal by a member.
1717	1717	1694 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
1718	1718	16953 business days following the receipt of all necessary information to establish the medical
1719	1719	1696necessity of the prescribed treatment; provided, however, that if additional delay would result in
1720	1720	1697significant risk to the member’s health or well-being, the carrier shall respond not more than 24
1721	1721	1698hours following the receipt of all necessary information to establish the medical necessity of the
1722	1722	1699prescribed treatment. If a response by the carrier is not received within the time required under
1723	1723	1700this subsection, an exception shall be deemed granted. 80 of 100
1724	1724	1701 (j) The carrier shall make changes in selected drugs not more than once annually and
1725	1725	1702shall provide notice to the division of insurance not less than 90 days before making such
1726	1726	1703changes to the selected drugs and an explanation of those changes. Upon verification by the
1727	1727	1704division of insurance that the selected drugs meet the criteria identified in subsection (c), the
1728	1728	1705carrier shall provide notice to its members not less than 30 days before any changes to the
1729	1729	1706selected drugs are made. This subsection shall apply to continuous glucose monitoring system
1730	1730	1707components and, when applicable, delivery devices in the same manner in which it applies to
1731	1731	1708drugs.
1732	1732	1709 (k) The carrier shall make public the drugs, continuous glucose monitoring system
1733	1733	1710components, all components of the system of which the component is a part and delivery device
1734	1734	1711selected pursuant to this section.
1735	1735	1712 (l) If a high deductible health plan subject to this section is used to establish a savings
1736	1736	1713account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1737	1737	1714section shall apply to the plan to the maximum extent possible without causing the account to
1738	1738	1715lose its tax-exempt status.
1739	1739	1716 SECTION 53. Section 2 of chapter 176O of the General Laws, as appearing in the 2022
1740	1740	1717Official Edition, is hereby amended by adding the following subsection:-
1741	1741	1718 (i) Every 3 years, a carrier that contracts with a pharmacy benefit manager shall
1742	1742	1719coordinate an audit of the operations of the pharmacy benefit manager to ensure compliance with
1743	1743	1720this chapter and to examine the pricing and rebates applicable to prescription drugs that are
1744	1744	1721provided to the carrier’s covered persons. 81 of 100
1745	1745	1722 SECTION 54. Said chapter 176O is hereby further amended by inserting after section 22
1746	1746	1723the following section:-
1747	1747	1724 Section 22A. Notwithstanding any other general or special law to the contrary, each
1748	1748	1725carrier shall require that a pharmacy benefit manager receive a license from the division under
1749	1749	1726chapter 176Y as a condition of contracting with that carrier.
1750	1750	1727 SECTION 55. Said chapter 176O is hereby further amended by adding the following
1751	1751	1728section:-
1752	1752	1729 Section 30. (a) For the purposes of this section, the following words shall have the
1753	1753	1730following meanings unless the context clearly requires otherwise:
1754	1754	1731 “Cost-sharing”, an amount owed by an individual under the terms of the individual’s
1755	1755	1732health benefit plan.
1756	1756	1733 “Pharmacy retail price”, the amount an individual would pay for a prescription drug at a
1757	1757	1734pharmacy if the individual purchased that prescription drug at that pharmacy without using a
1758	1758	1735health benefit plan or any other prescription drug benefit or discount.
1759	1759	1736 (b) At the point of sale, a pharmacy shall charge an individual the lesser of: (i)
1760	1760	1737appropriate cost-sharing amount; or (ii) pharmacy retail price; provided, however, that a carrier,
1761	1761	1738or an entity that manages or administers benefits for a carrier, shall not require an individual to
1762	1762	1739make a payment for a prescription drug at the point of sale in an amount that exceeds the lesser
1763	1763	1740of the: (A) individual’s cost share; or (B) pharmacy retail price.
1764	1764	1741 (c) A contract shall not: (i) prohibit a pharmacist from complying with this section; or (ii)
1765	1765	1742impose a penalty on the pharmacist or pharmacy for complying with this section. 82 of 100
1766	1766	1743 SECTION 56. The General Laws are hereby amended by inserting after chapter 176X the
1767	1767	1744following chapter:-
1768	1768	1745 Chapter 176Y. LICENSING AND REGULATION OF PHARMACY BENEFIT
1769	1769	1746MANAGERS.
1770	1770	1747 Section 1. As used in this chapter, the following words shall have the following meanings
1771	1771	1748unless the context clearly requires otherwise:
1772	1772	1749 “Carrier”, an insurer licensed or otherwise authorized to transact accident or health
1773	1773	1750insurance under chapter 175, a nonprofit hospital service corporation organized under chapter
1774	1774	1751176A, a non-profit medical service corporation organized under chapter 176B, a health
1775	1775	1752maintenance organization organized under chapter 176G and an organization entering into a
1776	1776	1753preferred provider arrangement under chapter 176I; provided, however, that “carrier” shall not
1777	1777	1754include an employer purchasing coverage or acting on behalf of its employees or the employees
1778	1778	1755of any subsidiary or affiliated corporation of the employer; and provided further, that unless
1779	1779	1756otherwise provided, “carrier” shall not include any entity to the extent it offers a policy,
1780	1780	1757certificate or contract that provides coverage solely for dental care services or vision care
1781	1781	1758services.
1782	1782	1759 “Center”, the center for health information and analysis established in chapter 12C.
1783	1783	1760 “Commissioner”, the commissioner of insurance.
1784	1784	1761 “Division”, the division of insurance.
1785	1785	1762 “Health benefit plan”, a contract, certificate or agreement entered into, offered or issued
1786	1786	1763by a carrier to provide, deliver, arrange for, pay for or reimburse any of the costs of health care 83 of 100
1787	1787	1764services; provided, however, that the commissioner may by regulation define other health
1788	1788	1765coverage as a “health benefit plan” for the purposes of this chapter.
1789	1789	1766 “Pharmacy”, a physical or electronic facility under the direction or supervision of a
1790	1790	1767registered pharmacist that is authorized to dispense prescription drugs and has entered into a
1791	1791	1768network contract with a pharmacy benefit manager or a carrier.
1792	1792	1769 “Pharmacy benefit manager”, a person, business or other entity, however organized, that
1793	1793	1770directly or through a subsidiary provides pharmacy benefit management services for prescription
1794	1794	1771drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
1795	1795	1772insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
1796	1796	1773management services shall include, but not be limited to: (i) the processing and payment of
1797	1797	1774claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing
1798	1798	1775of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or
1799	1799	1776grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii)
1800	1800	1777drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x)
1801	1801	1778clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of
1802	1802	1779covered prescription drugs; provided further, that “pharmacy benefit manager” shall not include
1803	1803	1780a health benefit plan sponsor unless otherwise specified by the division.
1804	1804	1781 Section 2. (a) No person, business or other entity shall establish or operate as a pharmacy
1805	1805	1782benefit manager without obtaining a license from the division pursuant to this section. A license
1806	1806	1783may be granted only when the division is satisfied that the entity possesses the necessary
1807	1807	1784organization, background expertise financial integrity to supply the services sought to be offered.
1808	1808	1785A pharmacy benefit manager license shall be valid for a period of 3 years and shall be renewable 84 of 100
1809	1809	1786for additional 3-year periods. Initial application and renewal fees for the license shall be
1810	1810	1787established pursuant to section 3B of chapter 7.
1811	1811	1788 (b) A license granted pursuant to this section and any rights or interests therein shall not
1812	1812	1789be transferable.
1813	1813	1790 (c) A person, business or other entity licensed as a pharmacy benefit manager shall
1814	1814	1791submit data and reporting information to the center according to the standards and methods
1815	1815	1792specified by the center pursuant to section 10A of chapter 12C.
1816	1816	1793 (d) The division may issue or renew a license pursuant to this section, subject to
1817	1817	1794restrictions in order to protect the interests of consumers. Such restrictions may include: (i)
1818	1818	1795limiting the type of services that a license holder may provide; (ii) limiting the activities in which
1819	1819	1796the license holder may be engaged; or (iii) addressing conflicts of interest between pharmacy
1820	1820	1797benefit managers and health plan sponsors.
1821	1821	1798 (e) The division shall develop an application for licensure of pharmacy benefit managers
1822	1822	1799that shall include, but not be limited to: (i) the name of the applicant or pharmacy benefit
1823	1823	1800manager; (ii) the address and contact telephone number for the applicant or pharmacy benefit
1824	1824	1801manager; (iii) the name and address of the agent of the applicant or pharmacy benefit manager
1825	1825	1802for service of process in the commonwealth; (iv) the name and address of any person with
1826	1826	1803management or control over the applicant or pharmacy benefit manager; and (v) any audited
1827	1827	1804financial statements specific to the applicant or pharmacy benefit manager. An applicant or
1828	1828	1805pharmacy benefit manager shall report to the division any material change to the information
1829	1829	1806contained in its application, certified by an officer of the pharmacy benefit manager, within 30
1830	1830	1807days of such a change. 85 of 100
1831	1831	1808 (f) The division may suspend, revoke, refuse to issue or renew or place on probation a
1832	1832	1809pharmacy benefit manager license for cause, which shall include, but not be limited to: (i) the
1833	1833	1810applicant or pharmacy benefit manager engaging in fraudulent activity that is found by a court of
1834	1834	1811law to be a violation of state or federal law; (ii) the division receiving consumer complaints that
1835	1835	1812justify an action under this chapter to protect the health, safety and interests of consumers; (iii)
1836	1836	1813the applicant or pharmacy benefit manager failing to pay an application or renewal fee for a
1837	1837	1814license; (iv) the applicant or pharmacy benefit manager failing to comply with reporting
1838	1838	1815requirements of the center under section 10A of chapter 12C; or (v) the applicant pharmacy
1839	1839	1816benefit manager’s failing to comply with a requirement of this chapter.
1840	1840	1817 The division shall provide written notice to the applicant or pharmacy benefit manager
1841	1841	1818and advise in writing of the reason for any suspension, revocation, refusal to issue or renew or
1842	1842	1819placement on probation of a pharmacy benefit manager license under this chapter. A copy of the
1843	1843	1820notice shall be forwarded to the center. The applicant or pharmacy benefit manager may make
1844	1844	1821written demand upon the division within 30 days of receipt of such notification for a hearing
1845	1845	1822before the division to determine the reasonableness of the division’s action. The hearing shall be
1846	1846	1823held pursuant to chapter 30A.
1847	1847	1824 The division shall not suspend or cancel a license unless the division has first afforded
1848	1848	1825the pharmacy benefit manager an opportunity for a hearing pursuant to said chapter 30A.
1849	1849	1826 (g) If a person, business or other entity performs the functions of a pharmacy benefit
1850	1850	1827manager in violation of this chapter, the person, business or other entity shall be subject to a fine
1851	1851	1828of $5,000 per day for each day that the person, business or other entity is found to be in violation. 86 of 100
1852	1852	1829Penalties collected under this subsection shall be deposited into the Prescription Drug Cost
1853	1853	1830Assistance Trust Fund established in section 2EEEEEE of chapter 29.
1854	1854	1831 (h) A pharmacy benefit manager licensed under this section shall notify a health carrier
1855	1855	1832client in writing of any activity, policy, practice contract or arrangement of the pharmacy benefit
1856	1856	1833manager that directly or indirectly presents any conflict of interest with the pharmacy benefit
1857	1857	1834manager’s relationship with or obligation to the health carrier client.
1858	1858	1835 (i) The division shall adopt any written policies, procedures or regulations that the
1859	1859	1836division determines are necessary to implement this section.
1860	1860	1837 Section 3. (a) The commissioner may make an examination of the affairs of a pharmacy
1861	1861	1838benefit manager when the commissioner deems prudent but not less frequently than once every 3
1862	1862	1839years. The focus of the examination shall be to ensure that a pharmacy benefit manager is able to
1863	1863	1840meet its responsibilities under contracts with carriers licensed under chapters 175, 176A, 176B,
1864	1864	1841or 176G. The examination shall be conducted according to the procedures set forth in paragraph
1865	1865	1842(6) of section 4 of chapter 175.
1866	1866	1843 (b) The commissioner, a deputy or an examiner may conduct an on-site examination of
1867	1867	1844each pharmacy benefit manager in the commonwealth to thoroughly inspect and examine its
1868	1868	1845affairs.
1869	1869	1846 (c) The charge for each such examination shall be determined annually according to the
1870	1870	1847procedures set forth in paragraph (6) of section 4 of chapter 175.
1871	1871	1848 (d) Not later than 60 days following completion of the examination, the examiner in
1872	1872	1849charge shall file with the commissioner a verified written report of examination under oath. 87 of 100
1873	1873	1850Upon receipt of the verified report, the commissioner shall transmit the report to the pharmacy
1874	1874	1851benefit manager examined with a notice that shall afford the pharmacy benefit manager
1875	1875	1852examined a reasonable opportunity of not more than 30 days to make a written submission or
1876	1876	1853rebuttal with respect to any matters contained in the examination report. Within 30 days of the
1877	1877	1854end of the period allowed for the receipt of written submissions or rebuttals, the commissioner
1878	1878	1855shall consider and review the reports together with any written submissions or rebuttals and any
1879	1879	1856relevant portions of the examiner’s work papers and enter an order:
1880	1880	1857 (i) adopting the examination report as filed with modifications or corrections and, if the
1881	1881	1858examination report reveals that the pharmacy benefit manager is operating in violation of this
1882	1882	1859section or any regulation or prior order of the commissioner, the commissioner may order the
1883	1883	1860pharmacy benefit manager to take any action the commissioner considers necessary and
1884	1884	1861appropriate to cure such violation;
1885	1885	1862 (ii) rejecting the examination report with directions to examiners to reopen the
1886	1886	1863examination for the purposes of obtaining additional data, documentation or information and re-
1887	1887	1864filing pursuant to this section; or
1888	1888	1865 (iii) calling for an investigatory hearing with not less than 20 days’ notice to the
1889	1889	1866pharmacy benefit manager for purposes of obtaining additional documentation, data, information
1890	1890	1867and testimony.
1891	1891	1868 (e) Notwithstanding any general or special law to the contrary, including clause Twenty-
1892	1892	1869sixth of section 7 of chapter 4 and chapter 66, the records of any such audit, examination or other
1893	1893	1870inspection and the information contained in the records, reports or books of any pharmacy
1894	1894	1871benefit manager examined pursuant to this section shall be confidential and open only to the 88 of 100
1895	1895	1872inspection of the commissioner, or the examiners and assistants. Access to such confidential
1896	1896	1873material may be granted by the commissioner to law enforcement officials of the commonwealth
1897	1897	1874or any other state or agency of the federal government at any time if the agency or office
1898	1898	1875receiving the information agrees in writing to keep such material confidential. Nothing in this
1899	1899	1876subsection shall be construed to prohibit the required production of such records, and
1900	1900	1877information contained in the reports of such company or organization before any court of the
1901	1901	1878commonwealth or any master or auditor appointed by any such court, in any criminal or civil
1902	1902	1879proceeding, affecting such pharmacy benefit manager, its officers, partners, directors or
1903	1903	1880employees. The final report of any such audit, examination or any other inspection by or on
1904	1904	1881behalf of the division of insurance shall be a public record.
1905	1905	1882 Section 4. (a) A pharmacy benefit manager shall not make payments to a pharmacy
1906	1906	1883benefit consultant or broker whose services were obtained by a health plan sponsor to work on
1907	1907	1884the pharmacy benefit bidding or contracting process if the payment constitutes a conflict of
1908	1908	1885interest, as determined by the commissioner. For purposes of this section, payments from a
1909	1909	1886pharmacy benefit manager to a pharmacy benefit consultant or broker shall include, but not be
1910	1910	1887limited to: (i) shared rebates from pharmaceutical manufacturers; (ii) per prescription fees; (iii)
1911	1911	1888per member fees; (iv) referral fees; (v) bonuses; or (vi) any other financial arrangement the
1912	1912	1889commissioner considers to be a conflict of interest.
1913	1913	1890 (b) The division shall adopt any written policies or procedures or promulgate regulations
1914	1914	1891that the division determines are necessary to implement this section.
1915	1915	1892 Section 5. A pharmacy benefit manager shall not, by contract, written policy or written
1916	1916	1893procedure, require that a pharmacy designated by the pharmacy benefit manager dispense a 89 of 100
1917	1917	1894medication directly to a patient with the expectation or intention that the patient will transport the
1918	1918	1895medication to a physician’s office, hospital or clinic for administration.
1919	1919	1896 SECTION 57. (a) Notwithstanding any general or special law to the contrary, the
1920	1920	1897commonwealth health insurance connector authority, in consultation with the division of
1921	1921	1898insurance, shall report on the impact of pharmaceutical pricing on health care costs and outcomes
1922	1922	1899for ConnectorCare and non-group and small group plans offered through the connector and its
1923	1923	1900members.
1924	1924	1901 The report shall include, but not be limited to: (i) information on the differential between
1925	1925	1902drug list price and price net of rebates for plans offered and the impact of those differentials on
1926	1926	1903member premiums; (ii) the relationship between drug list price and member cost-sharing
1927	1927	1904requirements; (iii) the impact of drug price changes over time on premium and out-of-pocket
1928	1928	1905costs in plans authorized under section 3 of chapter 176J of the General Laws offered through the
1929	1929	1906commonwealth health insurance connector authority; (iv) trends in changes in drug list price and
1930	1930	1907price net of rebates by health plan; (v) an analysis of the impact of member out-of-pocket costs
1931	1931	1908on drug utilization and member experience; and (vi) an analysis of the impact of drug list price
1932	1932	1909and price net of rebates on member formulary access to drug. Data collected under this
1933	1933	1910subsection shall be protected as confidential and shall not be a public record under clause
1934	1934	1911Twenty-sixth of section 7 of chapter 4 of the General Laws or under chapter 66 of the General
1935	1935	1912Laws.
1936	1936	1913 The report shall be submitted to the joint committee on health care financing and the
1937	1937	1914house and senate committees on ways and means not later than July 1, 2025; provided, however, 90 of 100
1938	1938	1915that the report shall be published on the website of the commonwealth health insurance
1939	1939	1916connector authority not later than July 1, 2025.
1940	1940	1917 (b) In fiscal year 2024, the amount required to be paid pursuant to the last paragraph of
1941	1941	1918section 6 of chapter 6D of the General Laws shall be increased by $500,000; provided, however,
1942	1942	1919that said $500,000 shall be provided to the commonwealth health insurance connector authority
1943	1943	1920not later than March 14, 2024 for data collection and analysis costs associated with the report
1944	1944	1921required by this section.
1945	1945	1922 SECTION 58. Notwithstanding any general or special law to the contrary, there shall be a
1946	1946	1923special commission to examine the feasibility of: (i) establishing a system for the bulk
1947	1947	1924purchasing and distribution of pharmaceutical products with a significant public health benefit
1948	1948	1925and the potential for significant health care cost savings for consumers through overall increased
1949	1949	1926purchase capacity; and (ii) making bulk purchase pricing information available to purchasers in
1950	1950	1927other states.
1951	1951	1928 The commission shall consist of: the commissioner of public health or a designee, who
1952	1952	1929shall serve as chair; the executive director of the group insurance commission or a designee; the
1953	1953	1930chief of pharmacy of the state office for pharmacy services; the MassHealth director of
1954	1954	1931pharmacy; the secretary of technology services and security; and 9 members to be appointed by
1955	1955	1932the commissioner of public health, 2 of whom shall be health care economists, 1 of whom shall
1956	1956	1933be an expert in health law and policy innovation, 1 of whom shall be an academic with relevant
1957	1957	1934expertise in the field, 1 of whom shall be a representative from a community health center, 1 of
1958	1958	1935whom shall be the chief executive officer of a hospital licensed in the commonwealth, 1 of
1959	1959	1936whom shall be a representative of the Massachusetts Association of Health Plans, Inc., 1 of 91 of 100
1960	1960	1937whom shall be a representative of Blue Cross Blue Shield of Massachusetts, Inc. and 1 of whom
1961	1961	1938shall be a member of the public with experience with health care and consumer protection.
1962	1962	1939 The commission shall hold not less than 3 public hearings in different geographic areas of
1963	1963	1940the commonwealth, accept input from the public and solicit expert testimony from individuals
1964	1964	1941representing health insurance carriers, pharmaceutical companies, independent and chain
1965	1965	1942pharmacies, hospitals, municipalities, health care practitioners, health care technology
1966	1966	1943professionals, community health centers, substance use disorder providers, public health
1967	1967	1944educational institutions and other experts identified by the commission.
1968	1968	1945 The commission shall consider: (i) the process by which the commonwealth could make
1969	1969	1946bulk purchases of pharmaceutical products with a significant public health benefit and the
1970	1970	1947potential for significant health care cost savings to consumers; (ii) the process by which both
1971	1971	1948governmental and nongovernmental entities may participate in a collaborative to purchase
1972	1972	1949pharmaceutical products with a significant public health benefit and the potential for significant
1973	1973	1950health care cost savings; (iii) the feasibility of developing an electronic information interchange
1974	1974	1951system to exchange bulk purchase price information with partnering states; (iv) potential sources
1975	1975	1952of funding available to implement bulk purchases; (v) potential cost savings of bulk purchases to
1976	1976	1953the commonwealth or other participating nongovernmental entities; (vi) the feasibility of
1977	1977	1954partnering with the federal government, other states in the New England region or the state of
1978	1978	1955New York ; and (vii) any other factors that the commission deems relevant.
1979	1979	1956 The commission shall file a report of its analysis, along with any recommended
1980	1980	1957legislation, if any, to the clerks of the senate and house of representatives, the house and senate
1981	1981	1958committees on ways and means, the joint committee on health care financing, the joint 92 of 100
1982	1982	1959committee on public health, the joint committee on elder affairs and the joint committee on
1983	1983	1960mental health, substance use and recovery not later than September 1, 2024; provided, however,
1984	1984	1961that the report shall be published on the website of the department of public health not later than
1985	1985	1962September 1, 2024.
1986	1986	1963 SECTION 59. (a) As used in this section, the following words shall have the following
1987	1987	1964meanings unless the context clearly requires otherwise:
1988	1988	1965 “Chain pharmacist”, a pharmacist employed by a retail drug organization operating not
1989	1989	1966less than 10 retail drug stores within the commonwealth under section 39 of chapter 112 of the
1990	1990	1967General Laws.
1991	1991	1968 “Independent pharmacist”, a pharmacist actively engaged in the business of retail
1992	1992	1969pharmacy and employed in an organization of not more than 9 registered retail drugstores in the
1993	1993	1970commonwealth under said section 39 of said chapter 112 that employs not more than a total of
1994	1994	197120 full-time pharmacists.
1995	1995	1972 (b) There shall be a task force to: (i) review the drug supply chain and reimbursement
1996	1996	1973structures including, but not limited to: (A) plan and pharmacy benefit manager reimbursements
1997	1997	1974to pharmacies; (B) wholesaler prices to pharmacies; (C) pharmacy services administrative
1998	1998	1975organization fees and contractual relationships with pharmacies; and (D) drug manufacturer
1999	1999	1976prices to wholesalers; (ii) review ways to recognize the unique challenges of small and
2000	2000	1977independent pharmacies; (iii) identify methods to increase pricing transparency throughout the
2001	2001	1978supply chain; (iv) make recommendations on the use of multiple maximum allowable costs lists
2002	2002	1979and their frequency of use for mail order products; (v) review the utilization of maximum
2003	2003	1980allowable costs lists or similar reimbursement structures established by a pharmacy benefit 93 of 100
2004	2004	1981manager or payer; (vi) review the availability of drugs to independent and chain pharmacies on
2005	2005	1982the maximum allowable cost list or any similar reimbursement structures established by a
2006	2006	1983pharmacy benefit manager or payer; (vii) review the pharmacy acquisition cost from national or
2007	2007	1984regional wholesalers that serve pharmacies compared to the reimbursement amount provided
2008	2008	1985through a maximum allowable cost list or any similar reimbursement structures established by a
2009	2009	1986pharmacy benefit manager or payer and the conditions under which an adjustment to a
2010	2010	1987reimbursement is appropriate; (viii) review the timing of pharmacy purchases of products and the
2011	2011	1988relative risk of list price changes related to the timing of dispensing the products; (ix) assess
2012	2012	1989ways to increase transparency for chain and independent pharmacists to understand the
2013	2013	1990methodology used by a pharmacy benefit manager or payer to develop a maximum allowable
2014	2014	1991cost list or any similar reimbursement structure established by the pharmacy benefit manager or
2015	2015	1992payer; (x) assess the prevalence and appropriateness of pharmacy benefit managers requiring, or
2016	2016	1993using financial incentives or penalties to incentivize, customer use of pharmacies with whom the
2017	2017	1994pharmacy benefit manager has an ownership or financial interest; (xi) examine the impact of the
2018	2018	1995merger or consolidation of pharmacy benefit managers and health carrier clients on drug costs;
2019	2019	1996(xii) review current appeals processes for a chain or independent pharmacist to request an
2020	2020	1997adjustment on a reimbursement subject to a maximum allowable cost list or any similar
2021	2021	1998reimbursement structure established by a pharmacy benefit manager or payer; and (xiii) evaluate
2022	2022	1999the effect of differences between pharmacy benefit manager payments to pharmacies and charges
2023	2023	2000made to health carrier clients on drug price.
2024	2024	2001 (c) The task force shall consist of: the commissioner of insurance or a designee, who shall
2025	2025	2002serve as chair; and 9 members to be appointed by the commissioner, 2 of whom shall be
2026	2026	2003independent pharmacists employed in the independent pharmacy setting or representatives of 94 of 100
2027	2027	2004independent pharmacies, 2 of whom shall be chain pharmacists employed in the chain pharmacy
2028	2028	2005setting or representatives of chain pharmacies, 2 of whom shall be representatives of a pharmacy
2029	2029	2006benefit managers or payers who manage their own pharmacy benefit services, 1 of whom shall
2030	2030	2007represent the Massachusetts Association of Health Plans, Inc., 1 of whom shall represent Blue
2031	2031	2008Cross Blue Shield of Massachusetts, Inc. and 1 of whom shall be a representative of wholesalers
2032	2032	2009or pharmacy services administrative organizations. If more than 1 independent pharmacist is
2033	2033	2010appointed, each appointee shall represent a distinct practice setting. If more than 1 chain
2034	2034	2011pharmacist is appointed, each appointee shall represent a distinct practice setting. A pharmacy
2035	2035	2012benefit manager or payer appointed to the task force shall not be co-owned or have any
2036	2036	2013ownership relationship with any other payer, pharmacy benefit manager or chain pharmacist also
2037	2037	2014appointed to the task force.
2038	2038	2015 (d) The commissioner shall file the task force’s findings with the clerks of the house of
2039	2039	2016representatives and the senate, the joint committee on health care financing and the house and
2040	2040	2017senate committees on ways and means not later than December 1, 2024; provided, however, that
2041	2041	2018the findings shall be published on the website of the division of insurance not later than
2042	2042	2019December 1, 2024.
2043	2043	2020 SECTION 60. The health policy commission shall consult with relevant stakeholders,
2044	2044	2021including, but not limited to, consumers, consumer advocacy organizations, organizations
2045	2045	2022representing people with disabilities and chronic health conditions, providers, provider
2046	2046	2023organizations, payers, pharmaceutical manufacturers, pharmacy benefit managers and health care
2047	2047	2024economists and other academics, to assist in the development and periodic review of regulations
2048	2048	2025to implement section 21 of chapter 6D of the General Laws, including, but not limited to: (i)
2049	2049	2026establishing the criteria and processes for identifying the proposed value of an eligible drug as 95 of 100
2050	2050	2027defined in said section 21 of said chapter 6D; and (ii) determining the appropriate price increase
2051	2051	2028for a public health essential drug as described within the definition of eligible drug in said
2052	2052	2029section 21 of said chapter 6D.
2053	2053	2030 The commission shall hold its first public outreach not more than 45 days after the
2054	2054	2031effective date of this act and shall, to the extent possible, ensure fair representation and input
2055	2055	2032from a diverse array of stakeholders.
2056	2056	2033 SECTION 61. Annually, each carrier shall report to the division of insurance the drugs
2057	2057	2034selected to be provided with no or limited cost-sharing under section 17T of chapter 32A of the
2058	2058	2035General Laws, section 10R of chapter 118E of the General Laws, section 47UU of chapter 175 of
2059	2059	2036the General Laws, section 8VV of chapter 176A of the General Laws, section 4VV of chapter
2060	2060	2037176B of the General Laws and section 4NN of chapter 176G of the General Laws. The division
2061	2061	2038of insurance shall consult with the health policy commission and the center for health and
2062	2062	2039information analysis to review the drugs to verify that the selected drugs meet the criteria
2063	2063	2040identified in said section 17T of said chapter 32A, said section 10R of said chapter 118E, said
2064	2064	2041section 47UU of said chapter 175, said section 8VV of said chapter 176A, said section 4VV of
2065	2065	2042said chapter 176B and said section 4NN of said chapter 176G. If a selected drug shall be deemed
2066	2066	2043by the division to not meet the criteria, the division may require a different drug to be selected.
2067	2067	2044The division shall disclose the list of drugs selected by each entity annually on the division’s
2068	2068	2045website. This section shall also apply to selected continuous glucose monitoring system
2069	2069	2046components and, when applicable, delivery devices.
2070	2070	2047 SECTION 62. Notwithstanding subsection (b) of section 15A of chapter 6D of the
2071	2071	2048General Laws, for the purposes of providing early notice under said section 15A of said chapter 96 of 100
2072	2072	20496D, the health policy commission shall determine a significant price increase for a generic drug
2073	2073	2050to be defined as a generic drug priced at $100 or more per wholesale acquisition cost unit that
2074	2074	2051increases in cost by 100 per cent or more during any 12-month period.
2075	2075	2052 SECTION 63. Section 62 is hereby repealed.
2076	2076	2053 SECTION 64. The health policy commission, in consultation with the department of
2077	2077	2054public health, the office of Medicaid, the group insurance commission and the division of
2078	2078	2055insurance, shall study and analyze health insurance payer, including public and private payer,
2079	2079	2056specialty pharmacy networks in the commonwealth. The study shall include: (i) a description of
2080	2080	2057the type of specialty drugs most often provided by specialty pharmacies; (ii) the impact of
2081	2081	2058existing health insurance payers’ specialty pharmacy networks on patient access, availability of
2082	2082	2059clinical support, continuity of care, safety, quality, cost sharing and health care costs; and (iii)
2083	2083	2060any recommendations for increasing patient access to and choice of specialty drugs, maintaining
2084	2084	2061high-quality specialty pharmacy standards and meeting the commonwealth’s health care cost
2085	2085	2062containment goals.
2086	2086	2063 The commission shall submit a report of its findings and recommendations to the clerks
2087	2087	2064of the senate and house of representatives, the senate and house committees on ways and means,
2088	2088	2065the joint committee on health care financing and the joint committee on public health not later
2089	2089	2066than July 1, 2024.
2090	2090	2067 SECTION 64A. The department of public health, in consultation with the department of
2091	2091	2068elementary and secondary education, executive office of public safety and security and the center
2092	2092	2069for health information and analysis established under section 2 of chapter 12C of the General
2093	2093	2070Laws, shall conduct a study on a state-wide policy on: (i) maintaining a stock supply of non- 97 of 100
2094	2094	2071patient specific epinephrine in elementary and secondary public schools for use by students in
2095	2095	2072schools, including students with individualized health care plans prescribing epinephrine
2096	2096	2073injections, in lieu of a policy that relies on parents and guardians to supply epinephrine for use by
2097	2097	2074students in schools; and (ii) police stations and fire stations maintaining a stock supply of non-
2098	2098	2075patient specific epinephrine for emergency community use. The study shall consider: (i) the
2099	2099	2076impacts of the policy on the health and safety of schools and the community as a whole; (ii) the
2100	2100	2077impacts of the policy on costs and savings for students’ families, municipalities, school districts,
2101	2101	2078MassHealth and other insurance plans; (iii) the number of types of epinephrine injectors that a
2102	2102	2079school would be required to stock to ensure student health and safety; (iv) training that would be
2103	2103	2080necessary to implement the policy, including training related to the use of epinephrine dose
2104	2104	2081calculation devices; (v) funding and cost-reduction mechanisms for the policy, including bulk
2105	2105	2082purchasing and an assessment on surcharge payors as defined in section 64 of chapter 118E of
2106	2106	2083the General Laws; (vi) the number of types of epinephrine injectors that a fire station or police
2107	2107	2084station would be required to stock to ensure community safety; and (vii) any additional
2108	2108	2085regulations necessary to implement the policy. The department of public health shall submit a
2109	2109	2086report of its findings and recommendations to the house and senate committees on ways and
2110	2110	2087means, the joint committee on education, the joint committee on public safety, the joint
2111	2111	2088committee on financial services and the joint committee on health care financing not later than
2112	2112	2089June 30, 2025.
2113	2113	2090 SECTION 64B. The department shall compile a report detailing the effectiveness, safety
2114	2114	2091and long-term public health impacts of weight loss medication for preventative care including,
2115	2115	2092but not limited to: (i) heart conditions; (ii) stroke; (iii) asthma; and (iv) diabetes. The report shall
2116	2116	2093be submitted to the clerks of the senate and house of representatives, the house and senate 98 of 100
2117	2117	2094committees on ways and means and the joint committee on health care financing not later than
2118	2118	2095July 1, 2025.
2119	2119	2096 SECTION 64C.The health policy commission, in consultation with the board of
2120	2120	2097registration in pharmacy and the division of insurance, shall study and analyze the performance
2121	2121	2098of pharmacists of primary care functions within their authorized scope of practice. The study
2122	2122	2099shall include, but not be limited to: (i) reimbursements that carriers currently provide to
2123	2123	2100pharmacists for the performance of primary care services that are authorized in a pharmacist’s
2124	2124	2101scope of practice in the commonwealth; (ii) primary care services that are authorized in a
2125	2125	2102pharmacist’s scope of practice in the commonwealth but are not currently reimbursed or are
2126	2126	2103inadequately reimbursed by carriers; (iii) primary care services that pharmacists are authorized to
2127	2127	2104perform; (iv) the extent to which pharmacists currently perform primary care services; (v)
2128	2128	2105reimbursement rates for comparable services performed by pharmacists in other states; (vi)
2129	2129	2106impact of pharmacist-provided primary care services on access to health care and overall costs of
2130	2130	2107the commonwealth’s health care system; and (vii) reimbursement levels needed to achieve
2131	2131	2108sustainability in delivery of primary care services by pharmacists. The commission shall submit a
2132	2132	2109report of its findings and recommendations to the clerks of the senate and house of
2133	2133	2110representatives, the senate and house committees on ways and means, the joint committee on
2134	2134	2111health care financing and the joint committee on public health not later than July 1, 2024. The
2135	2135	2112report shall be published on the website of the commission.
2136	2136	2113 SECTION 64D. The department of public health, in consultation with the attorney
2137	2137	2114general, district attorneys, patient advocates, health care practitioners and other relevant
2138	2138	2115stakeholders, shall analyze the effectiveness and sufficiency of the marketing code of conduct
2139	2139	2116established pursuant to chapter 111N of the General Laws. The department’s analysis shall 99 of 100
2140	2140	2117include, but not be limited to: (i) an evaluation of the reports, compliance information and data
2141	2141	2118required under sections 2A, 5 and 6 of said chapter 111N; (ii) a comparison of the marketing
2142	2142	2119code of conduct with similar rules established in other states; (iii) a review of any enforcement
2143	2143	2120actions taken for violations of said chapter 111N; (iv) a review of opioid marketing practices and
2144	2144	2121the direct impact of said practices on increased substance use disorders and related deaths; and
2145	2145	2122(v) an assessment of the need, and recommendations for implementation, for further
2146	2146	2123requirements to ensure marketing activities by pharmaceutical and medical device manufacturers
2147	2147	2124do not influence prescribing patterns in a manner that adversely affects patient care, which shall
2148	2148	2125include, but not be limited to, requiring the licensing of all pharmaceutical and medical device
2149	2149	2126representatives, including pharmaceutical or medical device manufacturing agents, as defined in
2150	2150	2127section 1 of said chapter 111N.
2151	2151	2128 The department shall file a report of its findings with the clerks of the senate and house of
2152	2152	2129representatives, the joint committee on public health, the joint committee on health care
2153	2153	2130financing, the senate committee on steering and policy and the senate and house committees on
2154	2154	2131ways and means not later than May 1, 2024.
2155	2155	2132 SECTION 65. The regulations required by subsection (c) of section 39K of chapter 112
2156	2156	2133of the General Laws shall be promulgated not later than December 31, 2023.
2157	2157	2134 SECTION 65A. The regulations required by subsections (e) and (f) of section 47VV of
2158	2158	2135chapter 175 of the General Laws shall be promulgated not later than 3 months after the effective
2159	2159	2136date of this act.
2160	2160	2137 SECTION 66. Sections 21 and 39 shall take effect on July 1, 2024.
2161	2161	2138 SECTION 67. Sections 41, 44, 45, 47, 48, 52 and 61 shall take effect on July 1, 2025. 100 of 100
2162	2162	2139 SECTION 68. Section 43 shall take effect on April 1, 2024.
2163	2163	2140 SECTION 69. Section 54 shall take effect on July 1, 2024.
2164	2164	2141 SECTION 70. Section 56 shall take effect on March 30, 2024.
2165	2165	2142 SECTION 71. Section 63 shall take effect on January 1, 2025.