Massachusetts 2023-2024 Regular Session

Massachusetts Senate Bill S2499 Compare Versions

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1	1	SENATE . . . . . . . . . . . . . . No. 2499
2	2	The Commonwealth of Massachusetts
3	3	_______________
4	4	In the One Hundred and Ninety-Third General Court
5	5	(2023-2024)
6	6	_______________
7	7	SENATE, November 9, 2023.
8	8	The committee on Senate Ways and Means to whom was referred the Senate Bill relative
9	9	to pharmaceutical access, costs and transparency (Senate, No. 2492), - reports, recommending
10	10	that the same ought to pass with an amendment substituting a new draft with the same title
11	11	(Senate, No. 2499).
12	12	For the committee,
13	13	Michael J. Rodrigues 1 of 85
14	14	FILED ON: 11/9/2023
15	15	SENATE . . . . . . . . . . . . . . No. 2499
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 85
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 85
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 85
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 85
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 85
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 increases including, but not limited to, the initial prices of drugs coming to market and
141	141	118subsequent price increases, changes in industry profit levels, marketing expenses, reverse
142	142	119payment patent settlements, the impact of manufacturer rebates, discounts and other price
143	143	120concessions on net pricing, the availability of alternative drugs or treatments, corporate
144	144	121ownership organizational structure and any other matters as determined by the commission. 7 of 85
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 85
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 85
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 2BBBBBB 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 85
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 selected pursuant to section 17T of chapter 32A, section 10R
220	220	197of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of
221	221	198chapter 176B and section 4NN of chapter 176G; or (v) other prescription drug products that may
222	222	199have a direct and significant impact and create affordability challenges for the state’s health care
223	223	200system and patients, as determined by the commission; provided, however, that the commission
224	224	201shall promulgate regulations to establish the type of prescription drug products classified under
225	225	202clause (v) prior to classification of any such prescription drug product under said clause (v).
226	226	203 “Manufacturer”, a pharmaceutical manufacturer of an eligible drug, or, when applicable,
227	227	204the manufacturer of a delivery device selected pursuant to section 17T of chapter 32A, section
228	228	20510R of chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV
229	229	206of chapter 176B and section 4NN of chapter 176G.
230	230	207 “Public health essential drug”, shall have the same meaning as defined in subsection (f)
231	231	208of section 13 of chapter 17. 11 of 85
232	232	209 (b) The commission shall review the impact of eligible drug costs on patient access;
233	233	210provided, however, that the commission may prioritize the review of eligible drugs based on
234	234	211potential impact to consumers.
235	235	212 In conducting a review of eligible drugs, the commission may require a manufacturer to
236	236	213disclose to the commission, within a reasonable time period, information relating to said
237	237	214manufacturer’s pricing of an eligible drug. The disclosed information shall be on a standard
238	238	215reporting form developed by the commission with the input of the manufacturers and shall
239	239	216include, but not be limited to:
240	240	217 (i) a schedule of the drug’s wholesale acquisition cost increases over the previous 5
241	241	218calendar years;
242	242	219 (ii) the manufacturer’s aggregate, company-level research and development and other
243	243	220relevant capital expenditures, including facility construction, for the most recent year for which
244	244	221final audited data are available;
245	245	222 (iii) a narrative description, absent proprietary information and written in plain language,
246	246	223of factors that contributed to reported changes in wholesale acquisition cost during the previous 5
247	247	224calendar years; and
248	248	225 (iv) any other information that the manufacturer wishes to provide to the commission or
249	249	226that the commission requests.
250	250	227 (c) Based on the records provided under subsection (b) and available information from
251	251	228the center for health information and analysis or an outside third party, the commission shall
252	252	229identify a proposed value for the eligible drug. The commission may request additional relevant 12 of 85
253	253	230information that it deems necessary from the manufacturer and from other entities, including, but
254	254	231not limited to, pharmacy benefit managers.
255	255	232 Any information, analyses or reports regarding an eligible drug review shall be provided
256	256	233to the manufacturer. The commission shall consider any clarifications or data provided by the
257	257	234manufacturer with respect to the eligible drug. The commission shall not base its determination
258	258	235on the proposed value of the eligible drug solely on the analysis or research of an outside third
259	259	236party and shall not employ a measure or metric that assigns a reduced value to the life extension
260	260	237provided by a treatment based on a pre-existing disability or chronic health condition of the
261	261	238individuals whom the treatment would benefit. If the commission relies upon a third party to
262	262	239provide cost-effectiveness analysis or research related to the proposed value of the eligible drug,
263	263	240such analysis or research shall also include, but not be limited to: (i) a description of the
264	264	241methodologies and models used in its analysis; (ii) any assumptions and potential limitations of
265	265	242research findings in the context of the results; and (iii) outcomes for affected subpopulations that
266	266	243utilize the drug, including, but not limited to, potential impacts on individuals of marginalized
267	267	244racial or ethnic groups and on individuals with specific disabilities or health conditions who
268	268	245regularly utilize the eligible drug.
269	269	246 (d) If, after review of an eligible drug and after receiving information from the
270	270	247manufacturer under subsection (b) or subsection (e), the commission determines that the
271	271	248manufacturer’s pricing of the eligible drug does not substantially exceed the proposed value of
272	272	249the drug, the commission shall notify the manufacturer, in writing, of its determination and shall
273	273	250evaluate other ways to mitigate the eligible drug’s cost in order to improve patient access to the
274	274	251eligible drug. The commission may engage with the manufacturer and other relevant
275	275	252stakeholders, including, but not limited to, patients, patient advocacy organizations, consumer 13 of 85
276	276	253advocacy organizations, providers, provider organizations and payers, to explore options for
277	277	254mitigating the cost of the eligible drug. Upon the conclusion of a stakeholder engagement
278	278	255process under this subsection, the commission shall issue recommendations on ways to reduce
279	279	256the cost of the eligible drug for the purpose of improving patient access to the eligible drug.
280	280	257Recommendations may include, but shall not be limited to: (i) an alternative payment plan or
281	281	258methodology; (ii) a bulk purchasing program; (iii) co-payment, deductible, co-insurance or other
282	282	259cost-sharing restrictions; and (iv) a reinsurance program to subsidize the cost of the eligible drug.
283	283	260The recommendations shall be publicly posted on the commission’s website and provided to the
284	284	261clerks of the house of representatives and senate, the joint committee on health care financing
285	285	262and the house and senate committees on ways and means.
286	286	263 (e) If, after review of an eligible drug, the commission determines that the manufacturer’s
287	287	264pricing of the eligible drug substantially exceeds the proposed value of the drug, the commission
288	288	265shall request that the manufacturer provide further information related to the pricing of the
289	289	266eligible drug and the manufacturer’s reasons for the pricing not later than 30 days after receiving
290	290	267the request.
291	291	268 (f) Not later than 60 days after receiving information from the manufacturer under
292	292	269subsection (b) or subsection (e), the commission shall confidentially issue a determination on
293	293	270whether the manufacturer’s pricing of an eligible drug substantially exceeds the commission’s
294	294	271proposed value of the drug. If the commission determines that the manufacturer’s pricing of an
295	295	272eligible drug substantially exceeds the proposed value of the drug, the commission shall
296	296	273confidentially notify the manufacturer, in writing, of its determination and may require the
297	297	274manufacturer to enter into an access and affordability improvement plan under section 22. 14 of 85
298	298	275 (g) Records disclosed by a manufacturer under this section shall: (i) be accompanied by
299	299	276an attestation that all information provided is true and correct; (ii) not be public records under
300	300	277clause Twenty-sixth of section 7 of chapter 4 or under chapter 66; and (iii) remain confidential;
301	301	278provided, however, that the commission may produce reports summarizing any findings;
302	302	279provided further, that any such report shall not be in a form that identifies specific prices charged
303	303	280for or rebate amounts associated with drugs by a manufacturer or in a manner that is likely to
304	304	281compromise the financial, competitive or proprietary nature of the information.
305	305	282 Any request for further information made by the commission under subsection (e) or any
306	306	283determination issued or written notification made by the commission under subsection (f) shall
307	307	284not be public records under said clause Twenty-sixth of said section 7 of said chapter 4 or under
308	308	285said chapter 66.
309	309	286 (h) The commission’s proposed value of an eligible drug and the commission’s
310	310	287underlying analysis of the eligible drug is not intended to be used to determine whether any
311	311	288individual patient meets prior authorization or utilization management criteria for the eligible
312	312	289drug. The proposed value and underlying analysis shall not be the sole factor in determining
313	313	290whether a drug is included in a formulary or whether the drug is subject to step therapy.
314	314	291 (i) If the manufacturer fails to timely comply with the commission’s request for records
315	315	292under subsection (b) or subsection (e), or otherwise knowingly obstructs the commission’s
316	316	293ability to issue its determination under subsection (f), including, but not limited to, by providing
317	317	294incomplete, false or misleading information, the commission may impose appropriate sanctions
318	318	295against the manufacturer, including reasonable monetary penalties not to exceed $500,000, in
319	319	296each instance. The commission shall seek to promote compliance with this section and shall only 15 of 85
320	320	297impose a civil penalty on the manufacturer as a last resort. Penalties collected under this
321	321	298subsection shall be deposited into the Prescription Drug Cost Assistance Trust Fund established
322	322	299in section 2BBBBBB of chapter 29.
323	323	300 (j) The commission shall adopt any written policies, procedures or regulations that the
324	324	301commission determines are necessary to effectuate the purpose of this section.
325	325	302 Section 22. (a) The commission shall establish procedures to assist manufacturers in
326	326	303filing and implementing an access and affordability improvement plan.
327	327	304 Upon providing written notice provided under subsection (f) of section 21, the
328	328	305commission may require that a manufacturer whose pricing of an eligible drug substantially
329	329	306exceeds the commission’s proposed value of the drug file an access and affordability
330	330	307improvement plan with the commission. Not later than 45 days after receipt of a notice under
331	331	308said subsection (f) of said section 21, a manufacturer shall: (i) file an access and affordability
332	332	309improvement plan; or (ii) provide written notice declining participation in the access and
333	333	310affordability improvement plan.
334	334	311 (b) An access and affordability improvement plan shall: (i) be generated by the
335	335	312manufacturer; (ii) identify the reasons for the manufacturer’s drug price; and (iii) include, but not
336	336	313be limited to, specific strategies, adjustments and action steps the manufacturer proposes to
337	337	314implement to address the cost of the eligible drug in order to improve the accessibility and
338	338	315affordability of the eligible drug for patients and the state’s health system. The proposed access
339	339	316and affordability improvement plan shall include specific identifiable and measurable expected
340	340	317outcomes and a timetable for implementation. The timetable for an access and affordability
341	341	318improvement plan shall not exceed 18 months. 16 of 85
342	342	319 (c) The commission shall approve any access and affordability improvement plan that it
343	343	320determines: (i) is reasonably likely to address the cost of an eligible drug in order to substantially
344	344	321improve the accessibility and affordability of the eligible drug for patients and the state’s health
345	345	322system; and (ii) has a reasonable expectation for successful implementation.
346	346	323 (d) If the commission determines that the proposed access and affordability improvement
347	347	324plan is unacceptable or incomplete, the commission may provide consultation on the criteria that
348	348	325have not been met and may allow an additional time period of not more than 30 calendar days for
349	349	326resubmission; provided, however, that all aspects of the access plan shall be proposed by the
350	350	327manufacturer and the commission shall not require specific elements for approval.
351	351	328 (e) Upon approval of the proposed access and affordability improvement plan, the
352	352	329commission shall notify the manufacturer to begin immediate implementation of the access and
353	353	330affordability improvement plan. Public notice shall be provided by the commission on its
354	354	331website, identifying that the manufacturer is implementing an access and affordability
355	355	332improvement plan; provided, however, that upon the successful completion of the access and
356	356	333affordability improvement plan, the identity of the manufacturer shall be removed from the
357	357	334commission's website. All manufacturers implementing an approved access improvement plan
358	358	335shall be subject to additional reporting requirements and compliance monitoring as determined
359	359	336by the commission. The commission shall provide assistance to the manufacturer in the
360	360	337successful implementation of the access and affordability improvement plan.
361	361	338 (f) All manufacturers shall work in good faith to implement the access and affordability
362	362	339improvement plan. At any point during the implementation of the access and affordability 17 of 85
363	363	340improvement plan, the manufacturer may file amendments to the access improvement plan,
364	364	341subject to approval of the commission.
365	365	342 (g) At the conclusion of the timetable established in the access and affordability
366	366	343improvement plan, the manufacturer shall report to the commission regarding the outcome of the
367	367	344access and affordability improvement plan. If the commission determines that the access and
368	368	345affordability improvement plan was unsuccessful, the commission shall: (i) extend the
369	369	346implementation timetable of the existing access and affordability improvement plan; (ii) approve
370	370	347amendments to the access and affordability improvement plan as proposed by the manufacturer;
371	371	348(iii) require the manufacturer to submit a new access and affordability improvement plan; or (iv)
372	372	349waive or delay the requirement to file any additional access and affordability improvement plans.
373	373	350 (h) The commission shall submit a recommendation for proposed legislation to the joint
374	374	351committee on health care financing if the commission determines that further legislative
375	375	352authority is needed to assist manufacturers with the implementation of access and affordability
376	376	353improvement plans or to otherwise ensure compliance with this section.
377	377	354 (i) An access and affordability improvement plan under this section shall remain
378	378	355confidential in accordance with section 2A.
379	379	356 (j) The commission may assess a civil penalty to a manufacturer of not more than
380	380	357$500,000, in each instance, if the commission determines that the manufacturer: (i) declined or
381	381	358willfully neglected to file an access and affordability improvement plan with the commission
382	382	359under subsection (a); (ii) failed to file an acceptable access and affordability improvement plan in
383	383	360good faith with the commission; (iii) failed to implement the access and affordability
384	384	361improvement plan in good faith; or (iv) knowingly failed to provide information required by this 18 of 85
385	385	362section to the commission or knowingly falsified the information. The commission shall seek to
386	386	363promote compliance with this section and shall only impose a civil penalty as a last resort.
387	387	364Penalties collected under this subsection shall be deposited into the Prescription Drug Cost
388	388	365Assistance Trust Fund established in section 2BBBBBB of chapter 29.
389	389	366 (k) If a manufacturer declines to enter into an access and affordability improvement plan
390	390	367under this section, the commission may publicly post the proposed value of the eligible drug,
391	391	368hold a public hearing on the proposed value of the eligible drug and solicit public comment. The
392	392	369manufacturer shall appear and testify at the public hearing held on the eligible drug’s proposed
393	393	370value. Upon the conclusion of a public hearing under this subsection, the commission shall issue
394	394	371recommendations on ways to reduce the cost of an eligible drug for the purpose of improving
395	395	372patient access to the eligible drug. The recommendations shall be publicly posted on the
396	396	373commission’s website and provided to the clerks of the house of representatives and senate, the
397	397	374joint committee on health care financing and the house and senate committees on ways and
398	398	375means.
399	399	376 If a manufacturer is deemed to not be acting in good faith to develop an acceptable or
400	400	377complete access and affordability improvement plan, the commission may publicly post the
401	401	378proposed value of the eligible drug, hold a public hearing on the proposed value of the eligible
402	402	379drug and solicit public comment. The manufacturer shall appear and testify at any hearing held
403	403	380on the eligible drug’s proposed value. Upon the conclusion of a public hearing under this
404	404	381subsection, the commission shall issue recommendations on ways to reduce the cost of an
405	405	382eligible drug for the purpose of improving patient access to the eligible drug. The
406	406	383recommendations shall be publicly posted on the commission’s website and provided to the 19 of 85
407	407	384clerks of the house of representatives and senate, the joint committee on health care financing
408	408	385and the house and senate committees on ways and means.
409	409	386 Before making a determination that the manufacturer is not acting in good faith, the
410	410	387commission shall send a written notice to the manufacturer that the commission shall deem the
411	411	388manufacturer to not be acting in good faith if the manufacturer does not submit an acceptable
412	412	389access and affordability improvement plan within 30 days of receipt of notice; provided,
413	413	390however, that the commission shall not send a notice under this paragraph within 120 calendar
414	414	391days from the date that the commission notified the manufacturer of its requirement to enter into
415	415	392the access and affordability improvement plan.
416	416	393 (l) The commission shall promulgate regulations necessary to implement this section.
417	417	394 Section 23. Every 2 years, the commission, in consultation with the center for health
418	418	395information and analysis, the group insurance commission, the office of Medicaid and the
419	419	396division of insurance shall evaluate the impact of section 17T of chapter 32A, section 10R of
420	420	397chapter 118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of
421	421	398chapter 176B and section 4NN of chapter 176G on the effects of capping co-payments and
422	422	399eliminating deductible and co-insurance requirements for those drugs for individuals with
423	423	400diabetes, asthma and chronic heart conditions on health care access and system cost, including,
424	424	401but not limited to: (i) utilization rates of the drugs selected pursuant to section 10R of chapter
425	425	402118E, section 47UU of chapter 175, section 8VV of chapter 176A, section 4VV of chapter 176B
426	426	403and section 4NN of chapter 176G; (ii) an analysis of the use of those drugs, broken down by
427	427	404patient demographics, geographic region and, where applicable, delivery device; (iii) annual plan
428	428	405costs and member premiums; (iv) the average price of those drugs; (v) the average price of those 20 of 85
429	429	406drugs net of rebates or discounts received by or accrued directly or indirectly by health insurance
430	430	407carriers; (vi) average and total out-of-pocket expenditures on delivery devices used for those
431	431	408drugs and glucose monitoring tests that are not included as part of the underlying drug
432	432	409prescription; (vii) an analysis of the impact of capping co-payments and eliminating deductible
433	433	410and co-insurance requirements for those drugs on patient access to and cost of care by patient
434	434	411demographics and geographic region; and (viii); any barriers to accessing those drugs for
435	435	412individuals with the conditions for which those drugs are prescribed and policy recommendations
436	436	413for resolving such barriers.
437	437	414 Biennially, not later than November 30, the commission shall file a report of its findings
438	438	415with the clerks of the house of representatives and senate, the chairs of the joint committee on
439	439	416public health, the chairs of the joint committee on health care financing and the chairs of house
440	440	417and senate committees on ways and means.
441	441	418 SECTION 22. Section 1 of chapter 12C of the General Laws, as appearing in the 2022
442	442	419Official Edition, is hereby amended by inserting after the definition of “Ambulatory surgical
443	443	420center services” the following 3 definitions:-
444	444	421 “Average manufacturer price”, the average price paid to a manufacturer for a drug in the
445	445	422commonwealth by a: (i) wholesaler for drugs distributed to pharmacies; and (ii) pharmacy that
446	446	423purchases drugs directly from the manufacturer.
447	447	424 “Biosimilar”, a drug that is produced or distributed pursuant to a biologics license
448	448	425application approved under 42 U.S.C. 262(k)(3).
449	449	426 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
450	450	427drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an 21 of 85
451	451	428application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
452	452	429is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
453	453	430Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
454	454	431application that was approved by the United States Secretary of Health and Human Services
455	455	432under section 505(c) of the federal Food, Drug and Cosmetic Act, 21 U.S.C. 355(c), before the
456	456	433date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
457	457	4341984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
458	458	435C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
459	459	436under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the carrier as a brand name drug based on
460	460	437available data resources such as Medi-Span.
461	461	438 SECTION 23. Said section 1 of said chapter 12C, as so appearing, is hereby further
462	462	439amended by inserting after the definition of “General health supplies, care or rehabilitative
463	463	440services and accommodations” the following definition:-
464	464	441 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
465	465	442abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
466	466	443drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
467	467	444that was not originally marketed under a new drug application; or (iv) identified by the carrier as
468	468	445a generic drug based on available data resources such as Medi-Span.
469	469	446 SECTION 24. Said section 1 of said chapter 12C, as so appearing, is hereby further
470	470	447amended by inserting after the definition of “Patient-centered medical home” the following 2
471	471	448definitions:- 22 of 85
472	472	449 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
473	473	450preparation, propagation, compounding, conversion or processing of prescription drugs, directly
474	474	451or indirectly, by extraction from substances of natural origin, independently by means of
475	475	452chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
476	476	453repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
477	477	454“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed
478	478	455under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
479	479	456chapter 112.
480	480	457 “Pharmacy benefit manager”, a person, business or other entity, however organized, that,
481	481	458directly or through a subsidiary, provides pharmacy benefit management services for prescription
482	482	459drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
483	483	460insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
484	484	461management services shall include, but not be limited to: (i) the processing and payment of
485	485	462claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing
486	486	463of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or
487	487	464grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii)
488	488	465drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x)
489	489	466clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of
490	490	467covered prescription drugs; provided further, that “pharmacy benefit manager” shall include a
491	491	468health benefit plan sponsor that does not contract with a pharmacy benefit manager and manages
492	492	469its own prescription drug benefits unless specifically exempted by the commission.
493	493	470 SECTION 25. Said section 1 of said chapter 12C, as so appearing, is hereby further
494	494	471amended by adding the following definition:- 23 of 85
495	495	472 “Wholesale acquisition cost”, shall have the same meaning as defined in 42 U.S.C.
496	496	4731395w-3a(c)(6)(B).
497	497	474 SECTION 26. Section 3 of said chapter 12C, as so appearing, is hereby amended by
498	498	475inserting after the word “organizations”, in lines 13 and 14, the following words:- ,
499	499	476pharmaceutical manufacturing companies, pharmacy benefit managers.
500	500	477 SECTION 27. Said section 3 of said chapter 12C, as so appearing, is hereby further
501	501	478amended by striking out, in line 24, the words “and payer” and inserting in place thereof the
502	502	479following words:- , payer, pharmaceutical manufacturing company and pharmacy benefit
503	503	480manager.
504	504	481 SECTION 28. Section 5 of said chapter 12C, as so appearing, is hereby amended by
505	505	482striking out, in lines 11 and 12, the words “and public health care payers” and inserting in place
506	506	483thereof the following words:- , public health care payers, pharmaceutical manufacturing
507	507	484companies and pharmacy benefit managers.
508	508	485 SECTION 29. Said section 5 of said chapter 12C, as so appearing, is hereby further
509	509	486amended by striking out, in line 15, the words “and affected payers” and inserting in place
510	510	487thereof the following words:- affected payers, affected pharmaceutical manufacturing companies
511	511	488and affected pharmacy benefit managers.
512	512	489 SECTION 30. The first paragraph of section 7 of said chapter 12C, as so appearing, is
513	513	490hereby amended by adding the following sentence:- Each pharmaceutical and biopharmaceutical
514	514	491manufacturing company and pharmacy benefit manager shall pay to the commonwealth an
515	515	492amount for the estimated expenses of the center and for the other purposes described in this
516	516	493chapter. 24 of 85
517	517	494 SECTION 31. Said section 7 of said chapter 12C, as so appearing, is hereby further
518	518	495amended by striking out, in lines 8 and 42, the figure “33” and inserting in place thereof, in each
519	519	496instance, the following figure:- 25.
520	520	497 SECTION 32. Said section 7 of said chapter 12C, as so appearing, is hereby further
521	521	498amended by adding the following paragraph:-
522	522	499 The assessed amount for pharmaceutical and biopharmaceutical manufacturing
523	523	500companies and pharmacy benefit managers shall be not less than 25 per cent of the amount
524	524	501appropriated by the general court for the expenses of the center minus amounts collected from:
525	525	502(i) filing fees; (ii) fees and charges generated by the commission's publication or dissemination
526	526	503of reports and information; and (iii) federal matching revenues received for these expenses or
527	527	504received retroactively for expenses of predecessor agencies. A pharmacy benefit manager that is
528	528	505also a surcharge payor subject to the preceding paragraph and manages its own prescription drug
529	529	506benefits shall not be subject to additional assessment under this paragraph.
530	530	507 SECTION 33. Said chapter 12C is hereby further amended by inserting after section 10
531	531	508the following section:-
532	532	509 Section 10A. (a) The center shall promulgate regulations necessary to ensure the uniform
533	533	510reporting of information from pharmaceutical manufacturing companies to enable the center to
534	534	511analyze: (i) year-over-year changes in wholesale acquisition cost and average manufacturer price
535	535	512for prescription drug products; (ii) year-over-year trends in net expenditures; (iii) net
536	536	513expenditures on subsets of biosimilar, brand name and generic drugs identified by the center; (iv)
537	537	514trends in estimated aggregate drug rebates, discounts or other remuneration paid or provided by a
538	538	515pharmaceutical manufacturing company to a pharmacy benefit manager, wholesaler, distributor, 25 of 85
539	539	516health carrier client, health plan sponsor or pharmacy in connection with utilization of the
540	540	517pharmaceutical drug products offered by the pharmaceutical manufacturing company; (v)
541	541	518discounts provided by a pharmaceutical manufacturing company to a consumer in connection
542	542	519with utilization of the pharmaceutical drug products offered by the pharmaceutical
543	543	520manufacturing company, including any discount, rebate, product voucher, coupon or other
544	544	521reduction in a consumer’s out-of-pocket expenses including co-payments and deductibles under
545	545	522section 3 of chapter 175H; (vi) research and development costs as a percentage of revenue; (vii)
546	546	523annual marketing and advertising costs, identifying costs for direct-to-consumer advertising;
547	547	524(viii) annual profits over the most recent 5-year period; (ix) disparities between prices charged to
548	548	525purchasers in the commonwealth and purchasers outside of the United States; and (x) any other
549	549	526information deemed necessary by the center.
550	550	527 The center shall require the submission of available data and other information from
551	551	528pharmaceutical manufacturing companies including, but not limited to: (i) wholesale acquisition
552	552	529costs and average manufacturer prices for prescription drug products as identified by the center;
553	553	530(ii) true net typical prices charged to pharmacy benefits managers by payor type for prescription
554	554	531drug products identified by the center, net of any rebate or other payments from the manufacturer
555	555	532to the pharmacy benefits manager and from the pharmacy benefits manager to the manufacturer;
556	556	533(iii) aggregate, company-level research and development costs to the extent attributable to a
557	557	534specific product and other relevant capital expenditures for the most recent year for which final
558	558	535audited data is available for prescription drug products as identified by the center; (iv) annual
559	559	536marketing and advertising expenditures; and (v) a description, absent proprietary information and
560	560	537written in plain language, of factors that contributed to reported changes in wholesale acquisition 26 of 85
561	561	538costs, net prices and average manufacturer prices for prescription drug products as identified by
562	562	539the center.
563	563	540 (b) The center shall promulgate regulations necessary to ensure the uniform reporting of
564	564	541information from pharmacy benefit managers to enable the center to analyze: (i) trends in
565	565	542estimated aggregate drug rebates and other drug price reductions, if any, provided by a pharmacy
566	566	543benefit manager to a health carrier client or health plan sponsor or passed through from a
567	567	544pharmacy benefit manager to a health carrier client or health plan sponsor in connection with
568	568	545utilization of drugs in the commonwealth offered through the pharmacy benefit manager and a
569	569	546measure of lives covered by each health carrier client or health plan sponsor in the
570	570	547commonwealth; (ii) pharmacy benefit manager practices with regard to drug rebates and other
571	571	548drug price reductions, if any, provided by a pharmacy benefit manager to a health carrier client
572	572	549or health plan sponsor or to consumers in the commonwealth or passed through from a pharmacy
573	573	550benefit manager to a health carrier client or health plan sponsor or to consumers in the
574	574	551commonwealth; and (iii) any other information deemed necessary by the center.
575	575	552 The center shall require the submission of available data and other information from
576	576	553pharmacy benefit managers including, but not limited to: (i) true net typical prices paid by
577	577	554pharmacy benefits managers for prescription drug products identified by the center, net of any
578	578	555rebate or other payments from the manufacturer to the pharmacy benefit manager and from the
579	579	556pharmacy benefit manager to the manufacturer; (ii) the amount of all rebates that the pharmacy
580	580	557benefit manager received from all pharmaceutical manufacturing companies for all health carrier
581	581	558clients in the aggregate and for each health carrier client or health plan sponsor individually,
582	582	559attributable to patient utilization in the commonwealth; (iii) the administrative fees that the
583	583	560pharmacy benefit manager received from all health carrier clients or health plan sponsors in the 27 of 85
584	584	561aggregate and for each health carrier client or health plans sponsors individually; (iv) the
585	585	562aggregate amount of rebates a pharmacy benefit manager: (A) retains based on its contractual
586	586	563arrangement with each health plan client or health plan sponsor individually; and (B) passes
587	587	564through to each health care client individually; (v) the aggregate amount of all retained rebates
588	588	565that the pharmacy benefit manager received from all pharmaceutical manufacturing companies
589	589	566and did not pass through to each pharmacy benefit manager’s health carrier client or health plan
590	590	567sponsor individually; (vi) the percentage of contracts that a pharmacy benefit manager holds
591	591	568where the pharmacy benefit manager: (A) retains all rebates; (B) passes all rebates through to the
592	592	569client; and (C) shares rebates with the client; and (vii) other information as determined by the
593	593	570center, including, but not limited to, pharmacy benefit manager practices related to spread
594	594	571pricing, administrative fees, claw backs and formulary placement.
595	595	572 (c) Except as specifically provided otherwise by the center or under this chapter, data
596	596	573collected by the center pursuant to this section from pharmaceutical manufacturing companies
597	597	574and pharmacy benefit managers shall not be a public record under clause Twenty-sixth of section
598	598	5757 of chapter 4 or under chapter 66.
599	599	576 SECTION 34. Said chapter 12C is hereby further amended by striking out section 11, as
600	600	577appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
601	601	578 Section 11. The center shall ensure the timely reporting of information required under
602	602	579sections 8, 9, 10 and 10A. The center shall notify private health care payers, providers, provider
603	603	580organizations, pharmacy benefit managers, pharmaceutical manufacturing companies and their
604	604	581parent organization and other affiliates of any applicable reporting deadlines. The center shall
605	605	582notify, in writing, a private health care payer, provider, provider organization, pharmacy benefit 28 of 85
606	606	583manager or pharmaceutical manufacturing company and their parent organization and other
607	607	584affiliates, that has failed to meet a reporting deadline of such failure and that failure to respond
608	608	585within 2 weeks of the receipt of the notice may result in penalties. The center may assess a
609	609	586penalty against a private health care payer, provider, provider organization, pharmacy benefit
610	610	587manager or pharmaceutical manufacturing company and their parent organization and other
611	611	588affiliates, that fails, without just cause, to provide the requested information, including subsets of
612	612	589the requested information, within 2 weeks following receipt of the written notice required under
613	613	590this section, of not more than $2,000 per week for each week of delay after the 2-week period
614	614	591following receipt of the notice. Amounts collected under this section shall be deposited in the
615	615	592Healthcare Payment Reform Fund established in section 100 of chapter 194 of the acts of 2011.
616	616	593 SECTION 35. Section 12 of said chapter 12C, as so appearing, is hereby amended by
617	617	594striking out, in line 2, the words “and 10” and inserting in place thereof the following words:- ,
618	618	59510 and 10A.
619	619	596 SECTION 36. Subsection (a) of section 16 of said chapter 12C, as so appearing, is hereby
620	620	597amended by striking out the first sentence and inserting in place thereof the following sentence:-
621	621	598The center shall publish an annual report based on the information submitted under: (i) sections
622	622	5998, 9, 10 and 10A concerning health care provider, provider organization, private and public
623	623	600health care payer, pharmaceutical manufacturing company and pharmacy benefit manager costs
624	624	601and cost and price trends; (ii) section 13 of chapter 6D relative to market power reviews; and (iii)
625	625	602section 15 of said chapter 6D relative to quality data.
626	626	603 SECTION 37. Said section 16 of said chapter 12C, as so appearing, is hereby further
627	627	604amended by striking out, in line 18, the words:- “in the aggregate”. 29 of 85
628	628	605 SECTION 38. Said section 16 of said chapter 12C, as so appearing, is hereby further
629	629	606amended by inserting after the second paragraph the following paragraph:-
630	630	607 As part of its annual report, the center shall report on prescription drug utilization and
631	631	608spending for pharmaceutical drugs provided in an outpatient setting or sold in a retail setting for
632	632	609private and public health care payers, including, but not limited to, information sufficient to
633	633	610show the: (i) highest utilization drugs; (ii) drugs with the greatest increases in utilization; (iii)
634	634	611drugs that are most impactful on plan spending, net of rebates; and (iv) drugs with the highest
635	635	612year-over-year price increases, net of rebates. The report shall not contain any data that is likely
636	636	613 to compromise the financial, competitive or proprietary nature of the information
637	637	614contained in the report.
638	638	615 SECTION 39. Section 13 of chapter 17 of the General Laws, as so appearing, is hereby
639	639	616amended by adding the following subsection:-
640	640	617 (f) As used in this subsection, the following words shall have the following meanings
641	641	618unless the context clearly requires otherwise:
642	642	619 “Public health essential drug”, a prescription drug, biologic or biosimilar approved by the
643	643	620United States Food and Drug Administration that: (i) appears on the Model List of Essential
644	644	621Medicines most recently adopted by the World Health Organization; (ii) is selected pursuant to
645	645	622section 17T of chapter 32A, section 10R of chapter 118E, section 47UU of chapter 175, section
646	646	6238VV of chapter 176A, section 4VV of chapter 176B and section 4NN of chapter 176G; or (iii) is
647	647	624deemed an essential medicine by the commission due to its efficacy in treating a life-threatening
648	648	625health condition or a chronic health condition that substantially impairs an individual’s ability to
649	649	626engage in activities of daily living or because limited access to a certain population would pose a 30 of 85
650	650	627public health challenge. “Public health essential drug” shall also include all delivery devices
651	651	628selected pursuant to section 17T of chapter 32A, section 10R of chapter 118E, section 47UU of
652	652	629chapter 175, section 8VV of chapter 176A, section 4VV of chapter 176B and section 4NN of
653	653	630chapter 176G.
654	654	631 The commission shall identify and publish a list of public health essential drugs. The list
655	655	632shall be updated not less than annually and be made publicly available on the department’s
656	656	633website; provided, however, that the commission may provide an interim listing of a public
657	657	634health essential drug prior to an annual update. The commission shall notify and forward a copy
658	658	635of the list to the health policy commission established under chapter 6D.
659	659	636 SECTION 40. Chapter 29 of the General Laws is hereby amending by inserting after
660	660	637section 2AAAAAA the following section:-
661	661	638 2BBBBBB. (a) There shall be a Prescription Drug Cost Assistance Trust Fund. The
662	662	639secretary of health and human services shall administer the fund and shall make expenditures
663	663	640from the fund, without further appropriation, to provide financial assistance to residents of the
664	664	641commonwealth for the cost of prescription drugs through the prescription drug costs assistance
665	665	642program established under section 245 of chapter 111. For the purpose of this section,
666	666	643“prescription drug” shall include the prescription drug and any drug delivery device needed to
667	667	644administer the drug that is not included as part of the underlying drug prescription.
668	668	645 The fund shall consist of: (i) revenue from appropriations or other money authorized by
669	669	646the general court and specifically designated to be credited to the fund; and (ii) funds from public
670	670	647or private sources, including, but not limited to, gifts, grants, donations, rebates and settlements
671	671	648received by the commonwealth that are specifically designated to be credited to the fund. Money 31 of 85
672	672	649remaining in the fund at the close of a fiscal year shall not revert to the General Fund and shall
673	673	650be available for expenditure in the following fiscal year.
674	674	651 (b) Annually, not later than March 1, the secretary shall report on the fund’s activities
675	675	652detailing expenditures from the previous calendar year. The report shall include: (i) the number
676	676	653of individuals who received financial assistance from the fund; (ii) the breakdown of fund
677	677	654recipients by race, gender, age range, geographic region and income level; (iii) a list of all
678	678	655prescription drugs that were covered by money from the fund; and (iv) the total cost savings
679	679	656received by all fund recipients and the cost savings broken down by race, gender, age range and
680	680	657income level. The report shall be submitted to the clerks of the senate and house of
681	681	658representatives, senate and house committees on ways and means and the joint committee on
682	682	659health care financing.
683	683	660 (c) The secretary shall promulgate regulations or issue other guidance for the expenditure
684	684	661of the funds under this section.
685	685	662 SECTION 41. Chapter 32A of the General Laws is hereby amended by inserting after
686	686	663section 17S the following section:-
687	687	664 Section 17T. (a) As used in this section, the following terms shall have the following
688	688	665meanings, unless the context clearly requires otherwise:
689	689	666 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
690	690	667drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
691	691	668application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
692	692	669is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
693	693	670Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug 32 of 85
694	694	671application that was approved by the United States Secretary of Health and Human Services
695	695	672under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
696	696	673date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
697	697	6741984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
698	698	675C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
699	699	676under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
700	700	677based on available data resources such as Medi-Span.
701	701	678 “Delivery device”, a device that is used to deliver a brand name drug or generic drug and
702	702	679that an individual can obtain with a prescription.
703	703	680 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
704	704	681abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
705	705	682drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962,
706	706	683and was not originally marketed under a new drug application; or (iv) identified by the health
707	707	684benefit plan as a generic drug based on available data resources such as Medi-Span.
708	708	685 “Separate delivery device”, a device that is used to deliver a brand name drug or a
709	709	686generic drug and that can be obtained with a prescription separate from, or in addition to, the
710	710	687brand name drug or generic drug that the device delivers.
711	711	688 (b) The commission shall select 1 generic drug and 1 brand name drug used to treat each
712	712	689of the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) heart conditions, including,
713	713	690but not limited to, those heart conditions that disproportionately impact a particular demographic
714	714	691group, including people of color. 33 of 85
715	715	692 The commission shall select insulin as the drug used to treat diabetes. In selecting 1
716	716	693insulin brand name drug and 1 insulin generic drug as the drug used to treat diabetes, the
717	717	694commission shall select 1 insulin brand name drug per dosage and type, including rapid-acting,
718	718	695short-acting, intermediate-acting, long-acting, ultra long-acting and premixed. To the extent
719	719	696possible, the commission shall select 1 generic insulin per dosage and type, including rapid-
720	720	697acting, short-acting, intermediate-acting, long-acting, ultra long-acting and premixed, subject to
721	721	698such generic drug’s availability.
722	722	699 (c) In selecting the 1 generic drug, the 1 brand name drug and the delivery device, when
723	723	700applicable, used to treat each chronic condition pursuant to subsection (b), the commission shall
724	724	701select a drug that is among the top three of the commission’s most prescribed or of the highest
725	725	702volume for the chronic condition, and shall consider whether the drug is:
726	726	703 (i) of clear benefit and strongly supported by clinical evidence;
727	727	704 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
728	728	705exacerbations of illness progression or improve quality of life;
729	729	706 (iii) relatively low cost when compared to the cost of an acute illness of incident
730	730	707prevented or delayed by the use of the service, treatment or drug;
731	731	708 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
732	732	709 (v) likely to have a considerable financial impact on individual patients by reducing or
733	733	710eliminating patient cost-sharing pursuant to this section; and
734	734	711 (vi) likely to enhance equity in disproportionately impacted demographic groups,
735	735	712including people of color. 34 of 85
736	736	713 (d) The commission shall provide coverage for the brand name drugs, generic drugs and
737	737	714delivery devices selected pursuant to subsection (b). Coverage for the selected generic drugs
738	738	715shall not be subject to any cost-sharing, including copayments and coinsurance, and shall not be
739	739	716subject to any deductible. Coverage for selected brand name drugs shall not be subject to any
740	740	717deductible or coinsurance and a copayment shall not exceed $25 per 30-day supply; provided,
741	741	718however, that nothing in this section shall prevent co-payments for a 30-day supply of the
742	742	719selected brand name drugs from being reduced below the amount specified in this section.
743	743	720 (e) If use of a brand name drug or generic drug that the commission selects requires a
744	744	721separate delivery device, the commission shall select a delivery device for that drug in
745	745	722accordance with the factors established in subsection (c) for selecting brand name drugs and
746	746	723generic drugs, to the extent possible. The commission shall provide coverage for the delivery
747	747	724device and the delivery device shall not be subject to any cost-sharing, including co-payments
748	748	725and co-insurance, and shall not be subject to any deductible.
749	749	726 (f) A member and their prescribing health care provider shall have access to a clear,
750	750	727readily accessible and convenient process to request to use a different brand name drug or
751	751	728generic drug of the same pharmacological class in place of a brand name drug or generic drug
752	752	729selected under subsection (b). Such request for an exception shall be granted if: (i) the brand
753	753	730name drugs and generic drugs selected under subsection (b) are contraindicated or will likely
754	754	731cause an adverse reaction in or physical or mental harm to the member; (ii) the brand name drugs
755	755	732and generic drugs selected under subsection (b) are expected to be ineffective based on the
756	756	733known clinical characteristics of the member and the known characteristics of the prescription
757	757	734drug regimen; (iii) the member or prescribing health care provider: (A) has provided
758	758	735documentation to the commission establishing that the member has previously tried the brand 35 of 85
759	759	736name drugs and generic drugs selected under subsection (b), or another prescription drug in the
760	760	737same pharmacologic class or with the same mechanism of action, while covered by the
761	761	738commission or by a previous health insurance carrier or a health benefit plan; and (B) such
762	762	739prescription drug was discontinued due to lack of efficacy or effectiveness, diminished effect or
763	763	740an adverse event; or (iv) the member or prescribing health care provider has provided
764	764	741documentation to the commission establishing that the member: (A) is stable on a prescription
765	765	742drug prescribed by the health care provider; and (B) switching drugs will likely cause an adverse
766	766	743reaction in or physical or mental harm to the member. When applicable this subsection shall
767	767	744apply to delivery devices.
768	768	745 (g) The commission shall implement a continuity of coverage to apply to members that
769	769	746are new to the commission and that provides coverage for a 90-day fill of a United States Food
770	770	747and Drug Administration-approved drug reimbursed through a pharmacy benefit that the member
771	771	748has already been prescribed and on which the member is stable, upon documentation by the
772	772	749member’s prescriber; provided, however, that the commission shall not apply any greater
773	773	750deductible, co-insurance, co-payments or out-of-pocket limits than would otherwise apply to
774	774	751other drugs covered by the plan; and provided further, that the commission shall provide a
775	775	752member or their prescribing health care provider with information regarding the request pursuant
776	776	753to subsection (f) within 30 days of a member or their health care provider contacting the
777	777	754commission to use a different brand name drug or generic drug of the same pharmacological
778	778	755class as the drugs selected pursuant to subsection (b).
779	779	756 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
780	780	757coverage pursuant to subsection (g), the commission shall provide coverage for the prescription 36 of 85
781	781	758drug or delivery device prescribed by the member’s health care provider at the same cost as
782	782	759required under subsection (d). A denial of an exception shall be eligible for appeal by a member.
783	783	760 (i) The commission shall grant or deny a request pursuant to subsection (f) and (g) not
784	784	761more than 3 business days following the receipt of all necessary information to establish the
785	785	762medical necessity of the prescribed treatment; provided, however, that if additional delay would
786	786	763result in significant risk to the member’s health or well-being, the commission shall respond not
787	787	764more than 24 hours following the receipt of all necessary information to establish the medical
788	788	765necessity of the prescribed treatment. If a response by the commission is not received within the
789	789	766time required under this subsection, an exception shall be deemed granted.
790	790	767 (j) The commission shall make changes in selected drugs and delivery devices not more
791	791	768than annually and shall provide notice to the health policy commission not less than 90 days
792	792	769before making changes to the selected drugs and delivery devices and an explanation of such
793	793	770changes. Upon verification by the health policy commission that the selected drugs meet the
794	794	771criteria identified in subsection (c), the commission shall provide notice to its members not less
795	795	772than 30 days before any changes to the selected drugs are made.
796	796	773 (k) The commission shall make public the drugs and delivery devices selected pursuant to
797	797	774this section.
798	798	775 (l) If a high deductible health plan subject to this section is used to establish a savings
799	799	776account that is tax-exempt under the federal Internal Revenue Code, the provisions in this section
800	800	777shall apply to the plan to the maximum extent possible without causing the account to lose its
801	801	778tax-exempt status. 37 of 85
802	802	779 SECTION 42. Chapter 111 of the General Laws is hereby amended by adding the
803	803	780following section:-
804	804	781 Section 245. (a) The department shall establish and administer a prescription drug cost
805	805	782assistance program, which shall be funded by the Prescription Drug Cost Assistance Trust Fund
806	806	783established in section 2BBBBBB of chapter 29. The program shall provide financial assistance
807	807	784for prescription drugs used to treat: (i) chronic respiratory conditions, including, but not limited
808	808	785to, chronic obstructive pulmonary disease and asthma; (ii) chronic heart conditions, including,
809	809	786but not limited to, those heart conditions that disproportionately impact a particular demographic
810	810	787group, including people of color; (iii) diabetes; and (iv) any other chronic condition identified by
811	811	788the department that disproportionately impacts a particular demographic group, including people
812	812	789of color; provided, however, that “prescription drug” shall include the prescription drug and any
813	813	790drug delivery device needed to administer the drug that is not included as part of the underlying
814	814	791drug prescription. Financial assistance shall cover the cost of any copayment, coinsurance and
815	815	792deductible for the prescription drug for an individual who is eligible for the program.
816	816	793 (b) An individual shall be eligible for the program if the individual: (i) is a resident of the
817	817	794commonwealth; (ii) has a current prescription from a health care provider for a drug that is used
818	818	795to treat a chronic condition listed in subsection (a); (iii) has a family income of not more than
819	819	796500 per cent of the federal poverty level; and (iv) is not enrolled in MassHealth.
820	820	797 (c) The department shall create an application process, which shall be available
821	821	798electronically and in hard copy form, to determine whether an individual meets the program
822	822	799eligibility requirements under subsection (b). The department shall determine an applicant’s
823	823	800eligibility and notify the applicant of the department’s determination within 10 business days of 38 of 85
824	824	801receiving the application. If necessary for its determination, the department may request
825	825	802additional information from the applicant; provided, however, that the department shall notify
826	826	803the applicant within 5 business days of receipt of the original application as to what specific
827	827	804additional information is being requested. If additional information is requested, the department
828	828	805shall, within 3 business days of receipt of the additional information, determine the applicant’s
829	829	806eligibility and notify said applicant of the department’s determination.
830	830	807 If the department determines that an applicant is not eligible for the program, the
831	831	808department shall notify the applicant and shall include in said notification the specific reasons
832	832	809why the applicant is not eligible. The applicant may appeal this determination to the department
833	833	810within 30 days of receiving such notification.
834	834	811 If the department determines that an applicant is eligible for the program, the department
835	835	812shall provide the applicant with a prescription drug cost assistance program identification card,
836	836	813which shall indicate the applicant’s eligibility; provided, however, that the program identification
837	837	814card shall include, but not be limited to, the applicant’s full name and the full name of the
838	838	815prescription drug that the applicant is eligible to receive under the program without having to pay
839	839	816a co-payment, co-insurance or deductible. An applicant’s program identification card shall be
840	840	817valid for 12 months and shall be renewable upon a redetermination of program eligibility.
841	841	818 (d) An individual with a valid program identification card may present such card at any
842	842	819pharmacy in the commonwealth and, upon presentation of such card, the pharmacy shall fill the
843	843	820individual’s prescription and provide the prescribed drug to the individual without requiring the
844	844	821individual to pay a co-payment, co-insurance or deductible; provided, however, that the
845	845	822pharmacy shall be reimbursed by the Prescription Drug Cost Assistance Trust Fund established 39 of 85
846	846	823in section 2BBBBBB of chapter 29 in a manner determined by the department, in an amount
847	847	824equal to what the pharmacy would have received had the individual been required to pay a co-
848	848	825payment, co-insurance or deductible.
849	849	826 (e) The department, in collaboration with the division of insurance, board of registration
850	850	827in pharmacy and stakeholders representing consumers, pharmacists, providers, hospitals and
851	851	828carriers, shall develop and implement a plan to educate consumers, pharmacists, providers,
852	852	829hospitals and carriers regarding eligibility for and enrollment in the program under this section.
853	853	830The plan shall include, but not be limited to, appropriate staff training, notices provided to
854	854	831consumers at the pharmacy and a designated website with information for consumers,
855	855	832pharmacists and other health care professionals.
856	856	833 (f) The department shall compile a report detailing information about the program from
857	857	834the previous calendar year. The report shall include: (i) the number of applications received,
858	858	835approved, denied and appealed; (ii) the total number of applicants approved, and the number of
859	859	836applicants approved broken down by race, gender, age range and income level; (iii) a list of all
860	860	837prescription drugs that qualify for the program under subsection (b) and a list of prescription
861	861	838drugs for which applicants actually received financial assistance; and (iv) the total cost savings
862	862	839received by all approved applicants and the cost savings broken down by race, gender, age range
863	863	840and income level. The report shall be submitted annually, not later than March 1, to the clerks of
864	864	841the senate and house of representatives, the house and senate committees on ways and means and
865	865	842the joint committee on health care financing.
866	866	843 (g) The department shall promulgate regulations or issue guidance for the implementation
867	867	844and enforcement of this section. 40 of 85
868	868	845 SECTION 43. Chapter 112 of the General Laws is hereby amended by inserting after
869	869	846section 39J the following section:-
870	870	847 Section 39K. (a) For the purposes of this section, “specialty pharmacy” may include any
871	871	848pharmacy engaged in the dispensing of specialty drugs as defined by the board.
872	872	849 The board shall establish a specialty pharmacy licensure category for pharmacies that
873	873	850ship, mail, sell or dispense specialty drugs into, within or from the commonwealth. The board
874	874	851shall ensure that all shipments of specialty pharmaceutical drugs from in-state pharmacies to out-
875	875	852of-state destinations comply with the licensing procedures applicable to pharmacies in the
876	876	853commonwealth.
877	877	854 (b) A specialty pharmacy shall designate a manager of record who shall disclose to the
878	878	855board the location, name and title of all principal managers and the name and Massachusetts
879	879	856license number of the designated manager of record annually and within 30 days after any
880	880	857change of office, corporate office or manager of record.
881	881	858 (c) The board shall: (i) adopt written policies or procedures or promulgate regulations
882	882	859that the board determines are necessary to implement this section; and (ii) establish standards for
883	883	860special handling, administration, quality, safety, and monitoring of specialty drugs; provided,
884	884	861however, that the board shall define the term “specialty drug” for the purposes of this section.
885	885	862 SECTION 44. Chapter 118E of the General Laws is hereby amended by inserting after
886	886	863section 10Q the following section:-
887	887	864 Section 10R. (a) As used in this section, the following terms shall have the following
888	888	865meanings unless the context clearly requires otherwise: 41 of 85
889	889	866 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
890	890	867drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
891	891	868application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
892	892	869is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
893	893	870Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
894	894	871application that was approved by the United States Secretary of Health and Human Services
895	895	872under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
896	896	873date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
897	897	8741984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
898	898	875C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
899	899	876under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
900	900	877based on available data resources such as Medi-Span.
901	901	878 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
902	902	879drug; and (ii) an individual can obtain with a prescription.
903	903	880 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
904	904	881abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
905	905	882drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
906	906	883and was not originally marketed under a new drug application; or (iv) identified by the health
907	907	884benefit plan as a generic drug based on available data resources such as Medi-Span.
908	908	885 “Separate delivery device”, a device that is used to deliver a brand name drug or a
909	909	886generic drug and that can be obtained with a prescription separate from, or in addition to, the
910	910	887brand name drug or generic drug that the device delivers. 42 of 85
911	911	888 (b) The division shall select 1 generic drug and 1 brand name drug used to treat each of
912	912	889the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) heart conditions, including,
913	913	890but not limited to those heart conditions that disproportionately impact a particular demographic
914	914	891group, including people of color.
915	915	892 The division shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
916	916	893brand name drug and 1 insulin generic drug, the division shall select 1 insulin brand name drug
917	917	894per dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting, ultra
918	918	895long-acting and premixed. To the extent possible, the division shall select 1 generic insulin per
919	919	896dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-
920	920	897acting and premixed, subject to such generic drug’s availability.
921	921	898 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
922	922	899condition, the division shall select a drug that is among the top three of the division’s most
923	923	900prescribed or of the highest volume for the chronic condition, and shall consider whether the
924	924	901drug is:
925	925	902 (i) of clear benefit and strongly supported by clinical evidence;
926	926	903 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
927	927	904exacerbations of illness progression or improve quality of life;
928	928	905 (iii) relatively low-cost when compared to the cost of an acute illness of incident
929	929	906prevented or delayed by the use of the service, treatment or drug;
930	930	907 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and 43 of 85
931	931	908 (v) likely to have a considerable financial impact on individual patients by reducing or
932	932	909eliminating patient cost-sharing pursuant to this section; and
933	933	910 (vi) likely to enhance equity in disproportionately impacted demographic groups,
934	934	911including people of color.
935	935	912 (d) The division and its contracted Medicaid managed care organizations, accountable
936	936	913care organizations, behavioral health management firms and third-party administrators shall
937	937	914provide coverage for the brand name drugs, generic drugs and delivery devices selected pursuant
938	938	915to subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-
939	939	916sharing, including co-payments and co-insurance, and shall not be subject to any deductible.
940	940	917Coverage for selected brand name drugs and delivery devices shall not be subject to any
941	941	918deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply;
942	942	919provided, however, that nothing in this section shall prevent co-payments for a 30-day supply of
943	943	920the selected brand name drugs from being reduced below the amount specified in this section.
944	944	921 (e) If use of a brand name drug or generic drug that the division selects requires a
945	945	922separate delivery device, the division shall select a delivery device for that drug in accordance
946	946	923with the provisions this section establishes for selecting brand name drugs and generic drugs, to
947	947	924the extent possible. The division shall provide coverage for the delivery device and the delivery
948	948	925device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
949	949	926shall not be subject to any deductible.
950	950	927 (f) An enrollee and their prescribing health care provider shall have access to a clear,
951	951	928readily accessible and convenient process to request to use a different brand name drug or
952	952	929generic drug of the same pharmacological class in place of a brand name drug or generic drug. 44 of 85
953	953	930Such request for an exception shall be granted if any of the following conditions are satisfied: (i)
954	954	931the brand name drugs and generic drugs selected pursuant to subsection (b) are contraindicated
955	955	932or will likely cause an adverse reaction in or physical or mental harm to the enrollee; (ii) the
956	956	933brand name drugs and generic drugs selected pursuant to subsection (b) are expected to be
957	957	934ineffective based on the known clinical characteristics of the enrollee and the known
958	958	935characteristics of the prescription drug regimen; (iii) the member or prescribing health care
959	959	936provider: (A) has provided documentation to the division establishing that the enrollee has
960	960	937previously tried the brand name drugs and generic drugs selected pursuant to subsection (b), or
961	961	938another prescription drug in the same pharmacologic class or with the same mechanism of
962	962	939action, while covered by the division or by a previous health insurance carrier or a health benefit
963	963	940plan; and (B) such prescription drug was discontinued due to lack of efficacy or effectiveness,
964	964	941diminished effect or an adverse event; (iv) the enrollee or prescribing health care provider has
965	965	942provided documentation to the division establishing that the enrollee: (A) is stable on a
966	966	943prescription drug prescribed by the health care provider; and (B) switching drugs will likely
967	967	944cause an adverse reaction in or physical or mental harm to the enrollee. When applicable this
968	968	945subsection shall apply to delivery devices.
969	969	946 (g) This section shall not apply to health plans providing coverage in the Senior Care
970	970	947Options program to MassHealth-only members who are ages 65 and older.
971	971	948 (h) The division shall implement a continuity of coverage policy for enrollees that are
972	972	949new to the Medicaid program and that provides coverage for a 90-day fill of a United States
973	973	950Food and Drug Administration-approved drug reimbursed through a pharmacy benefit that the
974	974	951member has already been prescribed and on which the member is stable, upon documentation by
975	975	952the member’s prescriber; provided, however, that the division shall not apply any greater 45 of 85
976	976	953deductible, coinsurance, copayments or out-of-pocket limits than would otherwise apply to other
977	977	954drugs covered by the plan; and provided further, that the commission shall provide a member or
978	978	955their prescribing health care provider with information regarding the request pursuant to
979	979	956subsection (f) within 30 days of a member or their health care provider contacting the
980	980	957commission to use a different brand name drug or generic drug of the same pharmacological
981	981	958class as the drugs selected pursuant to subsection (b).
982	982	959 (i) Upon granting a request pursuant to subsection (f) or (h), the division shall provide
983	983	960coverage for the prescription drug or delivery device prescribed by the member’s health care
984	984	961provider at the same cost as required under subsection (d). A denial of an exception shall be
985	985	962eligible for appeal by a member.
986	986	963 (j) The division shall grant or deny a request pursuant to subsection (f) or (h) not more
987	987	964than 3 business days following the receipt of all necessary information to establish the medical
988	988	965necessity of the prescribed treatment. If additional delay would result in significant risk to the
989	989	966member’s health or well-being, the division shall respond not more than 24 hours following the
990	990	967receipt of all necessary information to establish the medical necessity of the prescribed treatment.
991	991	968If a response by the division is not received within the time required under this subsection, an
992	992	969exception shall be deemed granted.
993	993	970 (k) The division shall make changes in selected drugs not more than once annually and
994	994	971shall provide notice to the health policy commission not less than 90 days before making
995	995	972changes to the selected drugs and delivery devices and an explanation of such changes. Upon
996	996	973verification by the health policy commission that the selected drugs meet the criteria identified in 46 of 85
997	997	974subsection (c), the division shall provide notice to its enrollees not less than 30 days before any
998	998	975changes to the selected drugs are made.
999	999	976 (l) The division shall make public the drugs and delivery devices selected pursuant to this
1000	1000	977section.
1001	1001	978 (m) If a high deductible health plan subject to this section is used to establish a savings
1002	1002	979account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1003	1003	980section shall apply to the plan to the maximum extent possible without causing the account to
1004	1004	981lose its tax-exempt status.
1005	1005	982 SECTION 45. Chapter 175 of the General Laws is hereby amended by inserting after
1006	1006	983section 47TT the following section:-
1007	1007	984 Section 47UU. (a) The following terms shall have the following meanings, unless the
1008	1008	985context clearly requires otherwise:
1009	1009	986 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1010	1010	987drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1011	1011	988application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
1012	1012	989is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1013	1013	990Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1014	1014	991application that was approved by the United States Secretary of Health and Human Services
1015	1015	992under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1016	1016	993date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
1017	1017	9941984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
1018	1018	995C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved 47 of 85
1019	1019	996under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
1020	1020	997based on available data resources such as Medi-Span.
1021	1021	998 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1022	1022	999drug; and (ii) an individual can obtain with a prescription.
1023	1023	1000 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1024	1024	1001abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1025	1025	1002drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1026	1026	1003and was not originally marketed under a new drug application; or (iv) identified by the health
1027	1027	1004benefit plan as a generic drug based on available data resources such as Medi-Span.
1028	1028	1005 “Separate delivery device”, a device that is used to deliver a brand name drug or a
1029	1029	1006generic drug and that can be obtained with a prescription separate from, or in addition to, the
1030	1030	1007brand name drug or generic drug that the device delivers.
1031	1031	1008 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1032	1032	1009chapter shall provide coverage for the brand name drugs, generic drugs and delivery devices
1033	1033	1010used to treat: (i) diabetes; (ii) asthma; and (iii) heart conditions, including, but not limited to,
1034	1034	1011those heart conditions that disproportionately impact a particular demographic group, including
1035	1035	1012people of color.
1036	1036	1013 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1037	1037	1014brand name drug and 1 insulin generic drug, the carrier shall select 1 insulin brand name drug per
1038	1038	1015dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-
1039	1039	1016acting and premixed. To the extent possible, the carrier shall select 1 generic insulin per dosage 48 of 85
1040	1040	1017and type including rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting
1041	1041	1018and premixed, subject to such generic drug’s availability.
1042	1042	1019 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
1043	1043	1020condition, the carrier shall select a drug that is among the top three of the carrier’s most
1044	1044	1021prescribed or of the highest volume for the chronic condition, and shall consider whether the
1045	1045	1022drug is:
1046	1046	1023 (i) of clear benefit and strongly supported by clinical evidence;
1047	1047	1024 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1048	1048	1025exacerbations of illness progression or improve quality of life;
1049	1049	1026 (iii) relatively low cost when compared to the cost of an acute illness of incident
1050	1050	1027prevented or delayed by the use of the service, treatment or drug;
1051	1051	1028 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1052	1052	1029 (v) likely to have a considerable financial impact on individual patients by reducing or
1053	1053	1030eliminating patient cost-sharing pursuant to this section; and
1054	1054	1031 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1055	1055	1032including people of color.
1056	1056	1033 (d) Any carrier offering a policy, contract or certificate of health insurance under this
1057	1057	1034chapter shall provide coverage for the brand name drugs and generic drugs selected pursuant to
1058	1058	1035subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing,
1059	1059	1036including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for
1060	1060	1037selected brand name drugs shall not be subject to any deductible or co-insurance and any co- 49 of 85
1061	1061	1038payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section
1062	1062	1039shall prevent co-payments for a 30-day supply of the selected brand name drugs from being
1063	1063	1040reduced below the amount specified in this section.
1064	1064	1041 (e) If use of a brand name drug or generic drug that the carrier selects requires a separate
1065	1065	1042delivery device, the carrier shall select a delivery device for that drug in accordance with the
1066	1066	1043criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the
1067	1067	1044extent possible. The carrier shall provide coverage for the delivery device and the delivery
1068	1068	1045device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1069	1069	1046shall not be subject to any deductible.
1070	1070	1047 (f) A member and their prescribing health care provider shall have access to a clear,
1071	1071	1048readily accessible and convenient process to request to use a different brand name drug or
1072	1072	1049generic drug of the same pharmacological class in place of a brand name drug or generic drug.
1073	1073	1050Such request for an exception shall be granted if: (i) the brand name drugs and generic drugs
1074	1074	1051selected pursuant to subsection (b) are contraindicated or will likely cause an adverse reaction in
1075	1075	1052or physical or mental harm to the member; (ii) the brand name drugs and generic drugs selected
1076	1076	1053pursuant to subsection (b) are expected to be ineffective based on the known clinical
1077	1077	1054characteristics of the member and the known characteristics of the prescription drug regimen;
1078	1078	1055(iii) the member or prescribing health care provider: (A) has provided documentation to the
1079	1079	1056carrier establishing that the member has previously tried the brand name drugs and generic drugs
1080	1080	1057selected pursuant to subsection (b), or another prescription drug in the same pharmacologic class
1081	1081	1058or with the same mechanism of action, while covered by the carrier or by a previous health
1082	1082	1059insurance carrier or a health benefit plan; and (B) such prescription drug was discontinued due to
1083	1083	1060lack of efficacy or effectiveness, diminished effect or an adverse event; or (iv) the member or 50 of 85
1084	1084	1061prescribing health care provider has provided documentation to the carrier establishing that the
1085	1085	1062member: (A) is stable on a prescription drug prescribed by the health care provider; and (B)
1086	1086	1063switching drugs will likely cause an adverse reaction in or physical or mental harm to the
1087	1087	1064member. When applicable this subsection shall apply to delivery devices.
1088	1088	1065 (g) The carrier shall implement a continuity of coverage policy to apply to members that
1089	1089	1066are new to the carrier and that provides coverage for a 90-day fill of a United States Food and
1090	1090	1067Drug Administration-approved drug reimbursed through a pharmacy benefit that the member has
1091	1091	1068already been prescribed and on which the member is stable, upon documentation by the
1092	1092	1069member’s prescriber; provided, however, that a carrier shall not apply any greater deductible,
1093	1093	1070coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1094	1094	1071covered by the plan; and provided further, that the commission shall provide a member or their
1095	1095	1072prescribing health care provider with information regarding the request pursuant to subsection (f)
1096	1096	1073within 30 days of a member or their health care provider contacting the commission to use a
1097	1097	1074different brand name drug or generic drug of the same pharmacological class as the drugs
1098	1098	1075selected pursuant to subsection (b).
1099	1099	1076 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1100	1100	1077coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug
1101	1101	1078or delivery device prescribed by the member’s health care provider at the same cost as required
1102	1102	1079under subsection (d). A denial of an exception shall be eligible for appeal by a member.
1103	1103	1080 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
1104	1104	10813 business days following the receipt of all necessary information to establish the medical
1105	1105	1082necessity of the prescribed treatment. If additional delay would result in significant risk to the 51 of 85
1106	1106	1083member’s health or well-being, the carrier shall respond not more than 24 hours following the
1107	1107	1084receipt of all necessary information to establish the medical necessity of the prescribed treatment.
1108	1108	1085If a response by the carrier is not received within the time required under this subsection, an
1109	1109	1086exception shall be deemed granted.
1110	1110	1087 (j) The carrier shall make changes in selected drugs and delivery devices not more than
1111	1111	1088once annually and shall provide notice to the health policy commission not less than 90 days
1112	1112	1089before making changes to the selected drugs and delivery devices and an explanation of such
1113	1113	1090changes. Upon verification by the health policy commission that the selected drugs meet the
1114	1114	1091criteria identified in subsection (c), the carrier shall provide notice to its members not less than
1115	1115	109230 days before any changes to the selected drugs are made.
1116	1116	1093 (k) The carrier shall make public the drugs and delivery devices selected pursuant to this
1117	1117	1094section.
1118	1118	1095 (j) If a high deductible health plan subject to this section is used to establish a savings
1119	1119	1096account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1120	1120	1097section shall apply to the plan to the maximum extent possible without causing the account to
1121	1121	1098lose its tax-exempt status.
1122	1122	1099 SECTION 46. Section 226 of said chapter 175, as appearing in the 2022 Official Edition,
1123	1123	1100is hereby amended by striking out subsection (a) and inserting in place thereof the following
1124	1124	1101subsection:-
1125	1125	1102 (a) For the purposes of this section, the term “pharmacy benefit manager” shall mean a
1126	1126	1103person, business or other entity, however organized, that directly or through a subsidiary
1127	1127	1104provides pharmacy benefit management services for prescription drugs and devices on behalf of 52 of 85
1128	1128	1105a health benefit plan sponsor, including, but not limited to, a self-insurance plan, labor union or
1129	1129	1106other third-party payer; provided, however, that pharmacy benefit management services shall
1130	1130	1107include, but not be limited to: (i) the processing and payment of claims for prescription drugs;
1131	1131	1108(ii) the performance of drug utilization review; (iii) the processing of drug prior authorization
1132	1132	1109requests; (iv) pharmacy contracting; (v) the adjudication of appeals or grievances related to
1133	1133	1110prescription drug coverage contracts; (vi) formulary administration; (vii) drug benefit design;
1134	1134	1111(viii) mail and specialty drug pharmacy services; (ix) cost containment; (x) clinical, safety and
1135	1135	1112adherence programs for pharmacy services; and (xi) managing the cost of covered prescription
1136	1136	1113drugs; provided further, that “pharmacy benefit manager” shall include a health benefit plan
1137	1137	1114sponsor that does not contract with a pharmacy benefit manager and manages its own
1138	1138	1115prescription drug benefits unless specifically exempted.
1139	1139	1116 SECTION 47. Chapter 176A of the General Laws is hereby amended by inserting after
1140	1140	1117section 8UU the following section:-
1141	1141	1118 Section 8VV. (a) As used in this section, the following terms shall have the following
1142	1142	1119meanings unless the context clearly requires otherwise:
1143	1143	1120 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1144	1144	1121drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1145	1145	1122application submitted under section 505(b)(2) of the federal Food, Drug, and Cosmetic Act that
1146	1146	1123is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1147	1147	1124Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1148	1148	1125application that was approved by the United States Secretary of Health and Human Services
1149	1149	1126under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the 53 of 85
1150	1150	1127date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
1151	1151	11281984, Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42
1152	1152	1129C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
1153	1153	1130under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
1154	1154	1131based on available data resources such as Medi-Span.
1155	1155	1132 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1156	1156	1133drug; and (ii) an individual can obtain with a prescription.
1157	1157	1134 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1158	1158	1135abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1159	1159	1136drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1160	1160	1137and was not originally marketed under a new drug application; or (iv) identified by the health
1161	1161	1138benefit plan as a generic drug based on available data resources such as Medi-Span.
1162	1162	1139 “Separate delivery device”, a device that is used to deliver a brand name drug or a
1163	1163	1140generic drug and that can be obtained with a prescription separate from, or in addition to, the
1164	1164	1141brand name drug or generic drug that the device delivers.
1165	1165	1142 (b) Any carrier offering a policy, contract, or certificate of health insurance under this
1166	1166	1143chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1167	1167	1144chronic conditions.
1168	1168	1145 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1169	1169	1146brand name drug and 1 insulin generic drug, the commission shall select 1 insulin brand name
1170	1170	1147drug per dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting,
1171	1171	1148ultra long-acting and premixed. To the extent possible, the commission shall select 1 generic 54 of 85
1172	1172	1149insulin per dosage and type including rapid-acting, short-acting, intermediate-acting, long-acting,
1173	1173	1150ultra long-acting and premixed, subject to such generic drug’s availability.
1174	1174	1151 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
1175	1175	1152condition, the carrier shall select a drug that is among the top three of the carrier’s most
1176	1176	1153prescribed or of the highest volume for the chronic condition, and shall consider whether the
1177	1177	1154drug is:
1178	1178	1155 (i) of clear benefit and strongly supported by clinical evidence;
1179	1179	1156 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1180	1180	1157exacerbations of illness progression or improve quality of life;
1181	1181	1158 (iii) relatively low-cost when compared to the cost of an acute illness of incident
1182	1182	1159prevented or delayed by the use of the service, treatment or drug;
1183	1183	1160 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1184	1184	1161 (v) likely to have a considerable financial impact on individual patients by reducing or
1185	1185	1162eliminating patient cost-sharing pursuant to this section; and
1186	1186	1163 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1187	1187	1164including people of color.
1188	1188	1165 (d) Any carrier offering a policy, contract or certificate of health insurance under this
1189	1189	1166chapter shall provide coverage for the brand name drugs and generic drugs selected pursuant to
1190	1190	1167subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing,
1191	1191	1168including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for
1192	1192	1169selected brand name drugs shall not be subject to any deductible or coinsurance and any 55 of 85
1193	1193	1170copayment shall not exceed $25 per 30-day supply; provided, however, that nothing in this
1194	1194	1171section shall prevent co-payments for a 30-day supply of the selected brand name drugs from
1195	1195	1172being reduced below the amount specified in this section.
1196	1196	1173 (e) If use of a brand name drug or generic drug that the carrier selects requires a separate
1197	1197	1174delivery device, the carrier shall select a delivery device for that drug in accordance with the
1198	1198	1175criteria established under subsection (c) for selecting brand name drugs and generic drugs, to the
1199	1199	1176extent possible. The carrier shall provide coverage for the delivery device, and the delivery
1200	1200	1177device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1201	1201	1178shall not be subject to any deductible.
1202	1202	1179 (f) A member and their prescribing health care provider shall have access to a clear,
1203	1203	1180readily accessible and convenient process to request to use a different brand name drug or
1204	1204	1181generic drug of the same pharmacological class in place of a brand name drug or generic drug.
1205	1205	1182Such request for an exception shall be granted if: (i) the brand name drugs and generic drugs
1206	1206	1183selected pursuant to subsection (b) are contraindicated or will likely cause an adverse reaction in
1207	1207	1184or physical or mental harm to the member; (ii) the brand name drugs and generic drugs selected
1208	1208	1185pursuant to subsection (b) are expected to be ineffective based on the known clinical
1209	1209	1186characteristics of the member and the known characteristics of the prescription drug regimen;
1210	1210	1187(iii) the member or prescribing health care provider: (A) has provided documentation to the
1211	1211	1188carrier establishing that the member has previously tried the brand name drugs and generic drugs
1212	1212	1189selected pursuant to subsection (b), or another prescription drug in the same pharmacologic class
1213	1213	1190or with the same mechanism of action, while covered by the carrier or by a previous health
1214	1214	1191insurance carrier or a health benefit plan; and (B) such prescription drug was discontinued due to
1215	1215	1192lack of efficacy or effectiveness, diminished effect or an adverse event; or (iv) the member or 56 of 85
1216	1216	1193prescribing health care provider has provided documentation to the carrier establishing that the
1217	1217	1194member: (A) is stable on a prescription drug prescribed by the health care provider; and (B)
1218	1218	1195switching drugs will likely cause an adverse reaction in or physical or mental harm to the
1219	1219	1196member. When applicable this subsection shall apply to delivery devices.
1220	1220	1197 (g) The carrier shall implement a continuity of coverage policy to apply to members that
1221	1221	1198are new to the plan and that provides coverage for a 90-day fill of a United States Food and Drug
1222	1222	1199Administration-approved drug reimbursed through a pharmacy benefit that the member has
1223	1223	1200already been prescribed and on which the member is stable, upon documentation by the
1224	1224	1201member’s prescriber; provided, however, that a carrier shall not apply any greater deductible,
1225	1225	1202coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
1226	1226	1203covered by the plan; and provided further, that the commission shall provide a member or their
1227	1227	1204prescribing health care provider with information regarding the request pursuant to subsection (f)
1228	1228	1205within 30 days of a member or their health care provider contacting the commission to use a
1229	1229	1206different brand name drug or generic drug of the same pharmacological class as the drugs
1230	1230	1207selected pursuant to subsection (b).
1231	1231	1208 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1232	1232	1209coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug
1233	1233	1210or delivery device prescribed by the member’s health care provider at the same cost as required
1234	1234	1211under subsection (d). A denial of an exception shall be eligible for appeal by a member.
1235	1235	1212 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
1236	1236	12133 business days following the receipt of all necessary information to establish the medical
1237	1237	1214necessity of the prescribed treatment. If additional delay would result in significant risk to the 57 of 85
1238	1238	1215member’s health or well-being, the carrier shall respond not more than 24 hours following the
1239	1239	1216receipt of all necessary information to establish the medical necessity of the prescribed treatment.
1240	1240	1217If a response by the carrier is not received within the time required under this subsection, an
1241	1241	1218exception shall be deemed granted.
1242	1242	1219 (j) The carrier shall make changes in selected drugs and delivery devices not more than
1243	1243	1220once annually and shall provide notice to the health policy commission not less than 90 days
1244	1244	1221before making changes to the selected drugs and delivery devices and an explanation of such
1245	1245	1222changes. Upon verification by the health policy commission that the selected drugs meet the
1246	1246	1223criteria identified in subsection (c), the carrier shall provide notice to its members not less than
1247	1247	122430 days before any changes to the selected drugs are made.
1248	1248	1225 (k) The carrier shall make public the drugs and delivery devices selected pursuant to this
1249	1249	1226section.
1250	1250	1227 (l) If a high deductible health plan subject to this section is used to establish a savings
1251	1251	1228account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1252	1252	1229section shall apply to the plan to the maximum extent possible without causing the account to
1253	1253	1230lose its tax-exempt status.
1254	1254	1231 SECTION 48. Chapter 176B of the General Laws is hereby amended by inserting after
1255	1255	1232section 4UU the following section:-
1256	1256	1233 Section 4VV. (a) As used in this section, the following words shall have the following
1257	1257	1234meanings unless the context clearly requires otherwise: 58 of 85
1258	1258	1235 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1259	1259	1236drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1260	1260	1237application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
1261	1261	1238is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1262	1262	1239Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1263	1263	1240application that was approved by the United States Secretary of Health and Human Services
1264	1264	1241under section 505(c) of the federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1265	1265	1242date of the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984,
1266	1266	1243Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 C.F.R.
1267	1267	1244447.502; (ii) produced or distributed pursuant to a biologics license application approved under
1268	1268	124542 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug based
1269	1269	1246on available data resources, including Medi-Span.
1270	1270	1247 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1271	1271	1248drug; and (ii) an individual can obtain with a prescription.
1272	1272	1249 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1273	1273	1250abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1274	1274	1251drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1275	1275	1252and was not originally marketed under a new drug application; or (iv) identified by the health
1276	1276	1253benefit plan as a generic drug based on available data resources such as Medi-Span.
1277	1277	1254 “Separate delivery device”, a device that: (i) is used to deliver a brand name drug or a
1278	1278	1255generic drug; and (ii)can be obtained with a prescription separate from or in addition to the brand
1279	1279	1256name drug or generic drug that the device delivers. 59 of 85
1280	1280	1257 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1281	1281	1258chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1282	1282	1259chronic conditions: (i) diabetes; (ii) asthma; and (iii) heart conditions, including, but not limited
1283	1283	1260to, those heart conditions that disproportionately impact a particular demographic group,
1284	1284	1261including people of color.
1285	1285	1262 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1286	1286	1263brand name drug and 1 insulin generic drug, the commission shall select 1 insulin brand name
1287	1287	1264drug per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting,
1288	1288	1265ultra long-acting and premixed. To the extent possible, the commission shall select 1 generic
1289	1289	1266insulin per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-
1290	1290	1267acting, ultra long-acting and premixed, subject to such generic drug’s availability.
1291	1291	1268 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
1292	1292	1269condition, the carrier shall select a drug that is among the top three of the carrier’s most
1293	1293	1270prescribed or of the highest volume for the chronic condition, and shall consider whether the
1294	1294	1271drug is:
1295	1295	1272 (i) of clear benefit and strongly supported by clinical evidence;
1296	1296	1273 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1297	1297	1274exacerbations of illness progression or improve quality of life;
1298	1298	1275 (iii) relatively low cost when compared to the cost of an acute illness or incident
1299	1299	1276prevented or delayed by the use of the service, treatment or drug;
1300	1300	1277 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; 60 of 85
1301	1301	1278 (v) likely to have a considerable financial impact on individual patients by reducing or
1302	1302	1279eliminating patient cost-sharing pursuant to this section; and
1303	1303	1280 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1304	1304	1281including people of color.
1305	1305	1282 (d) Any carrier offering a policy, contract or certificate of health insurance under this
1306	1306	1283chapter shall provide coverage for the brand name drugs and generic drugs selected pursuant to
1307	1307	1284subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing,
1308	1308	1285including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for
1309	1309	1286selected brand name drugs shall not be subject to any deductible or coinsurance and no
1310	1310	1287copayment shall exceed $25 per 30-day supply; provided, however, that nothing in this section
1311	1311	1288shall prevent co-payments for a 30-day supply of the selected brand name drugs from being
1312	1312	1289reduced below the amount specified in this section.
1313	1313	1290 (e) If use of a brand name drug or generic drug that the carrier selects requires a separate
1314	1314	1291delivery device, the carrier shall select a delivery device for that drug in accordance with the
1315	1315	1292criteria established under subsection (c) for selecting brand name drugs and generic drugs, to the
1316	1316	1293extent possible. The carrier shall provide coverage for the delivery device and the delivery
1317	1317	1294device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1318	1318	1295shall not be subject to any deductible.
1319	1319	1296 (f) A member and their prescribing health care provider shall have access to a clear,
1320	1320	1297readily accessible and convenient process to request to use a different brand name drug or
1321	1321	1298generic drug of the same pharmacological class in place of a brand name drug or generic drug.
1322	1322	1299Such request for an exception shall be granted if: (i) the brand name drugs and generic drugs 61 of 85
1323	1323	1300selected pursuant to said subsection (b) are contraindicated or will likely cause an adverse
1324	1324	1301reaction in or physical or mental harm to the member; (ii) the brand name drugs and generic
1325	1325	1302drugs selected pursuant to said subsection (b) are expected to be ineffective based on the known
1326	1326	1303clinical characteristics of the member and the known characteristics of the prescription drug
1327	1327	1304regimen; (iii) the member or prescribing health care provider: (A) has provided documentation to
1328	1328	1305the carrier establishing that the member has previously tried the brand name drugs and generic
1329	1329	1306drugs selected pursuant to said subsection (b) or another prescription drug in the same
1330	1330	1307pharmacologic class or with the same mechanism of action while covered by the carrier or by a
1331	1331	1308previous health insurance carrier or a health benefit plan; and (B) such prescription drug was
1332	1332	1309discontinued due to lack of efficacy or effectiveness, diminished effect or an adverse event; or
1333	1333	1310(iv) the member or prescribing health care provider has provided documentation to the carrier
1334	1334	1311establishing that the member: (A) is stable on a prescription drug prescribed by the health care
1335	1335	1312provider; and (B) switching drugs will likely cause an adverse reaction in or physical or mental
1336	1336	1313harm to the member. When applicable this subsection shall apply to delivery devices.
1337	1337	1314 (g) The carrier shall implement a continuity of coverage policy to apply to members who
1338	1338	1315are new to the plan and that provides coverage for a 90-day fill of a United States Food and Drug
1339	1339	1316Administration-approved drug reimbursed through a pharmacy benefit that the member has
1340	1340	1317already been prescribed and on which the member is stable, upon documentation by the
1341	1341	1318member’s prescriber; provided, however, that a carrier shall not apply any greater deductible,
1342	1342	1319coinsurance, copayment or out-of-pocket limit than would otherwise apply to other drugs
1343	1343	1320covered by the plan; and provided further, that the commission shall provide a member or their
1344	1344	1321prescribing health care provider with information regarding the request pursuant to subsection (f)
1345	1345	1322within 30 days of a member or their health care provider contacting the commission to use a 62 of 85
1346	1346	1323different brand name drug or generic drug of the same pharmacological class as the drugs
1347	1347	1324selected pursuant to subsection (b).
1348	1348	1325 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1349	1349	1326coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug
1350	1350	1327or delivery device prescribed by the member’s health care provider at the same cost as required
1351	1351	1328under subsection (d). A denial of an exception shall be eligible for appeal by a member.
1352	1352	1329 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
1353	1353	13303 business days following the receipt of all necessary information to establish the medical
1354	1354	1331necessity of the prescribed treatment. If additional delay would result in significant risk to the
1355	1355	1332member’s health or well-being, the carrier shall respond not more than 24 hours following the
1356	1356	1333receipt of all necessary information to establish the medical necessity of the prescribed treatment.
1357	1357	1334If a response by the carrier is not received within the time required under this subsection, an
1358	1358	1335exception shall be deemed granted.
1359	1359	1336 (j) The carrier shall make changes in selected drugs and delivery devices not more than
1360	1360	1337once annually and shall provide notice to the health policy commission not less than 90 days
1361	1361	1338before making any such changes to the selected drugs and delivery devices and an explanation of
1362	1362	1339those changes. Upon verification by the health policy commission that the selected drugs meet
1363	1363	1340the criteria identified in subsection (c), the carrier shall provide notice to its members not less
1364	1364	1341than 30 days before any changes to the selected drugs are made.
1365	1365	1342 (k) The carrier shall make public the drugs and delivery devices selected pursuant to this
1366	1366	1343section. 63 of 85
1367	1367	1344 (l) If a high deductible health plan subject to this section is used to establish a savings
1368	1368	1345account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1369	1369	1346section shall apply to the plan to the maximum extent possible without causing the account to
1370	1370	1347lose its tax-exempt status.
1371	1371	1348 SECTION 49. The fourth paragraph of section 3B of chapter 176D of the General Laws,
1372	1372	1349as appearing in the 2022 Official Edition, is hereby amended by inserting after the second
1373	1373	1350sentence the following sentence:- A carrier shall not prohibit the dispensing of specialty drugs
1374	1374	1351that are included in its pharmaceutical drug benefits to insureds by any network specialty
1375	1375	1352pharmacy licensed under section 39K of chapter 112; provided, however, that the pharmacy
1376	1376	1353agrees to the in-network reimbursement rate for the specialty drug.
1377	1377	1354 SECTION 50. Said section 3B of said chapter 176D, as so appearing, is hereby further
1378	1378	1355amended by striking out the fifth paragraph and inserting in place thereof the following
1379	1379	1356paragraph:-
1380	1380	1357 A carrier shall not prohibit a network pharmacy from offering and providing mail
1381	1381	1358delivery services to an insured; provided, however, that the network pharmacy agrees to the
1382	1382	1359reimbursement terms and conditions and discloses to the insured any delivery service fee
1383	1383	1360associated with the delivery service.
1384	1384	1361 SECTION 51. The eighth paragraph of said section 3B of said chapter 176D, as so
1385	1385	1362appearing, is hereby amended by adding the following sentence:- The term “specialty drugs”
1386	1386	1363shall mean a specialty drug as defined under section 39K of chapter 112.
1387	1387	1364 SECTION 52. Chapter 176G of the General Laws is hereby amended by inserting after
1388	1388	1365section 4MM the following section:- 64 of 85
1389	1389	1366 Section 4NN. (a) As used in this section. the following words shall have the following
1390	1390	1367meanings unless the context clearly requires otherwise:
1391	1391	1368 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
1392	1392	1369drug application approved under 21 U.S.C. 355(c) except for: (a) any drug approved through an
1393	1393	1370application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
1394	1394	1371is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
1395	1395	1372Administration, to a drug approved under 21 U.S.C. 355(c); (b) an abbreviated new drug
1396	1396	1373application that was approved by the United States Secretary of Health and Human Services
1397	1397	1374under section 505(c) of said federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
1398	1398	1375date of the enactment of the Drug Price Competition and Patent Term Restoration Act of 1984,
1399	1399	1376Public Law 98-417, 98 Stat. 1585; or (c) an authorized generic drug as defined by 42 C.F.R.
1400	1400	1377447.502; (ii) produced or distributed pursuant to a biologics license application approved under
1401	1401	137842 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug based
1402	1402	1379on available data resources, such as Medi-Span.
1403	1403	1380 “Delivery device”, a device that: (i) is used to deliver a brand name drug or a generic
1404	1404	1381drug; and (ii) an individual can obtain with a prescription.
1405	1405	1382 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
1406	1406	1383abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
1407	1407	1384drug as defined by 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
1408	1408	1385and was not originally marketed under a new drug application; or (iv) identified by the health
1409	1409	1386benefit plan as a generic drug based on available data resources, such as Medi-Span. 65 of 85
1410	1410	1387 “Separate delivery device”, a device that: (i) is used to deliver a brand name drug or a
1411	1411	1388generic drug; and (ii) can be obtained with a prescription separate from or in addition to the
1412	1412	1389brand name drug or generic drug that the device delivers.
1413	1413	1390 (b) Any carrier offering a policy, contract or certificate of health insurance under this
1414	1414	1391chapter shall select 1 generic drug and 1 brand name drug used to treat each of the following
1415	1415	1392chronic conditions: (i) diabetes; (ii) asthma; and (iii) heart conditions, including, but not limited
1416	1416	1393to, those heart conditions that disproportionately impact a particular demographic group,
1417	1417	1394including people of color.
1418	1418	1395 The carrier shall select insulin as the drug used to treat diabetes. In selecting 1 insulin
1419	1419	1396brand name drug and 1 insulin generic drug, the commission shall select 1 insulin brand name
1420	1420	1397drug per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-acting,
1421	1421	1398ultra long-acting and premixed. To the extent possible, the commission shall select 1 generic
1422	1422	1399insulin per dosage and type, including rapid-acting, short-acting, intermediate-acting, long-
1423	1423	1400acting, ultra long-acting and premixed, subject to such generic drug’s availability.
1424	1424	1401 (c) In selecting the 1 generic drug and 1 brand name drug used to treat each chronic
1425	1425	1402condition, the carrier shall select a drug that is among the top three of the commission’s most
1426	1426	1403prescribed or of the highest volume for the chronic condition, and shall consider whether the
1427	1427	1404drug is:
1428	1428	1405 (i) of clear benefit and strongly supported by clinical evidence;
1429	1429	1406 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
1430	1430	1407exacerbations of illness progression or improve quality of life; 66 of 85
1431	1431	1408 (iii) relatively low cost when compared to the cost of an acute illness or incident
1432	1432	1409prevented or delayed by the use of the service, treatment or drug;
1433	1433	1410 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud;
1434	1434	1411 (v) likely to have a considerable financial impact on individual patients by reducing or
1435	1435	1412eliminating patient cost-sharing pursuant to this section; and
1436	1436	1413 (vi) likely to enhance equity in disproportionately impacted demographic groups,
1437	1437	1414including people of color.
1438	1438	1415 (d) Any carrier offering a policy, contract, or certificate of health insurance under this
1439	1439	1416chapter shall provide coverage for the brand name drugs and generic drugs selected pursuant to
1440	1440	1417subsection (b). Coverage for the selected generic drugs shall not be subject to any cost-sharing,
1441	1441	1418including co-payments and co-insurance, and shall not be subject to any deductible. Coverage for
1442	1442	1419selected brand name drugs shall not be subject to any deductible or co-insurance and any co-
1443	1443	1420payment shall not exceed $25 per 30-day supply; provided, however, that nothing in this section
1444	1444	1421shall prevent co-payments for a 30-day supply of the selected brand name drugs from being
1445	1445	1422reduced below the amount specified in this section.
1446	1446	1423 (e) If use of a brand name drug or generic drug that the carrier selects requires a separate
1447	1447	1424delivery device, the carrier shall select a delivery device for that drug in accordance with the
1448	1448	1425criteria established in subsection (c) for selecting brand name drugs and generic drugs, to the
1449	1449	1426extent possible. The carrier shall provide coverage for the delivery device and the delivery
1450	1450	1427device shall not be subject to any cost-sharing, including co-payments and co-insurance, and
1451	1451	1428shall not be subject to any deductible. 67 of 85
1452	1452	1429 (f) A member and their prescribing health care provider shall have access to a clear,
1453	1453	1430readily accessible and convenient process to request to use a different brand name drug or
1454	1454	1431generic drug of the same pharmacological class in place of a brand name drug or generic drug.
1455	1455	1432Such request for an exception shall be granted if: (i) the brand name drugs and generic drugs
1456	1456	1433selected pursuant to said subsection (b) are contraindicated or will likely cause an adverse
1457	1457	1434reaction in or physical or mental harm to the member; (ii) the brand name drugs and generic
1458	1458	1435drugs selected pursuant to said subsection (b) are expected to be ineffective based on the known
1459	1459	1436clinical characteristics of the member and the known characteristics of the prescription drug
1460	1460	1437regimen; (iii) the member or prescribing health care provider: (A) has provided documentation to
1461	1461	1438the carrier establishing that the member has previously tried the brand name drugs and generic
1462	1462	1439drugs selected pursuant to subsection (b), or another prescription drug in the same pharmacologic
1463	1463	1440class or with the same mechanism of action, while covered by the carrier or by a previous health
1464	1464	1441insurance carrier or a health benefit plan; and (B) such prescription drug was discontinued due to
1465	1465	1442lack of efficacy or effectiveness, diminished effect or an adverse event; or (iv) the member or
1466	1466	1443prescribing health care provider has provided documentation to the carrier establishing that the
1467	1467	1444member: (A) is stable on a prescription drug prescribed by the health care provider; and (B)
1468	1468	1445switching drugs will likely cause an adverse reaction in or physical or mental harm to the
1469	1469	1446member. When applicable this subsection shall apply to delivery devices.
1470	1470	1447 (g) The carrier shall implement a continuity of coverage policy to apply to members who
1471	1471	1448are new to the plan and that provides coverage for a 90-day fill of a United States Food and Drug
1472	1472	1449Administration-approved drug reimbursed through a pharmacy benefit that the member has
1473	1473	1450already been prescribed and on which the member is stable, upon documentation by the
1474	1474	1451member’s prescriber; provided, however, that a carrier shall not apply any greater deductible, 68 of 85
1475	1475	1452coinsurance, copayment or out-of-pocket limit than would otherwise apply to other drugs
1476	1476	1453covered by the plan; and provided further, that the commission shall provide a member or their
1477	1477	1454prescribing health care provider with information regarding the request pursuant to subsection (f)
1478	1478	1455within 30 days of a member or their health care provider contacting the commission to use a
1479	1479	1456different brand name drug or generic drug of the same pharmacological class as the drugs
1480	1480	1457selected pursuant to subsection (b).
1481	1481	1458 (h) Upon granting a request pursuant to subsection (f) or implementing a continuity of
1482	1482	1459coverage pursuant to subsection (g), the carrier shall provide coverage for the prescription drug
1483	1483	1460or delivery device prescribed by the member’s health care provider at the same cost as required
1484	1484	1461under subsection (d). A denial of an exception shall be eligible for appeal by a member.
1485	1485	1462 (i) The carrier shall grant or deny a request pursuant to subsection (f) or (g) not more than
1486	1486	14633 business days following the receipt of all necessary information to establish the medical
1487	1487	1464necessity of the prescribed treatment. If additional delay would result in significant risk to the
1488	1488	1465member’s health or well-being, the carrier shall respond not more than 24 hours following the
1489	1489	1466receipt of all necessary information to establish the medical necessity of the prescribed treatment.
1490	1490	1467If a response by the carrier is not received within the time required under this subsection, an
1491	1491	1468exception shall be deemed granted.
1492	1492	1469 (j) The carrier shall make changes in selected drugs and delivery devices not more than
1493	1493	1470once annually and shall provide notice to the health policy commission not less than 90 days
1494	1494	1471before making any such changes to the selected drugs and delivery devices and an explanation of
1495	1495	1472those changes. Upon verification by the health policy commission that the selected drugs meet 69 of 85
1496	1496	1473the criteria identified in subsection (c), the carrier shall provide notice to its members not less
1497	1497	1474than 30 days before any changes to the selected drugs are made.
1498	1498	1475 (k) The carrier shall make public the drugs and delivery devices selected pursuant to this
1499	1499	1476section.
1500	1500	1477 (l) If a high deductible health plan subject to this section is used to establish a savings
1501	1501	1478account that is tax-exempt under the federal Internal Revenue Code, the provisions of this
1502	1502	1479section shall apply to the plan to the maximum extent possible without causing the account to
1503	1503	1480lose its tax-exempt status.
1504	1504	1481 SECTION 53. Section 2 of chapter 176O of the General Laws, as appearing in the 2022
1505	1505	1482Official Edition, is hereby amended by adding the following subsection:-
1506	1506	1483 (i) Every 3 years, a carrier that contracts with a pharmacy benefit manager shall
1507	1507	1484coordinate an audit of the operations of the pharmacy benefit manager to ensure compliance with
1508	1508	1485this chapter and to examine the pricing and rebates applicable to prescription drugs that are
1509	1509	1486provided to the carrier’s covered persons.
1510	1510	1487 SECTION 54. Said chapter 176O is hereby further amended by inserting after section 22
1511	1511	1488the following section:-
1512	1512	1489 Section 22A. Notwithstanding any other general or special law to the contrary, each
1513	1513	1490carrier shall require that a pharmacy benefit manager receive a license from the division under
1514	1514	1491chapter 176Y as a condition of contracting with that carrier.
1515	1515	1492 SECTION 55. Said chapter 176O is hereby further amended by adding the following
1516	1516	1493section:- 70 of 85
1517	1517	1494 Section 30. (a) For the purposes of this section, the following words shall have the
1518	1518	1495following meanings unless the context clearly requires otherwise:
1519	1519	1496 “Cost-sharing”, an amount owed by an individual under the terms of the individual’s
1520	1520	1497health benefit plan.
1521	1521	1498 “Pharmacy retail price”, the amount an individual would pay for a prescription drug at a
1522	1522	1499pharmacy if the individual purchased that prescription drug at that pharmacy without using a
1523	1523	1500health benefit plan or any other prescription drug benefit or discount.
1524	1524	1501 (b) At the point of sale, a pharmacy shall charge an individual the lesser of: (i)
1525	1525	1502appropriate cost-sharing amount; or (ii) pharmacy retail price; provided, however, that a carrier,
1526	1526	1503or an entity that manages or administers benefits for a carrier, shall not require an individual to
1527	1527	1504make a payment for a prescription drug at the point of sale in an amount that exceeds the lesser
1528	1528	1505of the: (A) individual’s cost share; or (B) pharmacy retail price.
1529	1529	1506 (c) A contract shall not: (i) prohibit a pharmacist from complying with this section; or (ii)
1530	1530	1507impose a penalty on the pharmacist or pharmacy for complying with this section.
1531	1531	1508 SECTION 56. The General Laws are hereby amended by inserting after chapter 176X the
1532	1532	1509following chapter:-
1533	1533	1510 Chapter 176Y. LICENSING AND REGULATION OF PHARMACY BENEFIT
1534	1534	1511MANAGERS.
1535	1535	1512 Section 1. As used in this chapter, the following words shall have the following meanings
1536	1536	1513unless the context clearly requires otherwise: 71 of 85
1537	1537	1514 “Carrier”, an insurer licensed or otherwise authorized to transact accident or health
1538	1538	1515insurance under chapter 175, a nonprofit hospital service corporation organized under chapter
1539	1539	1516176A, a non-profit medical service corporation organized under chapter 176B, a health
1540	1540	1517maintenance organization organized under chapter 176G and an organization entering into a
1541	1541	1518preferred provider arrangement under chapter 176I; provided, however, that “carrier” shall not
1542	1542	1519include an employer purchasing coverage or acting on behalf of its employees or the employees
1543	1543	1520of any subsidiary or affiliated corporation of the employer; and provided further, that unless
1544	1544	1521otherwise provided, “carrier” shall not include any entity to the extent it offers a policy,
1545	1545	1522certificate or contract that provides coverage solely for dental care services or vision care
1546	1546	1523services.
1547	1547	1524 “Center”, the center for health information and analysis established in chapter 12C.
1548	1548	1525 “Commissioner”, the commissioner of insurance.
1549	1549	1526 “Division”, the division of insurance.
1550	1550	1527 “Health benefit plan”, a contract, certificate or agreement entered into, offered or issued
1551	1551	1528by a carrier to provide, deliver, arrange for, pay for or reimburse any of the costs of health care
1552	1552	1529services; provided, however, that the commissioner may by regulation define other health
1553	1553	1530coverage as a “health benefit plan” for the purposes of this chapter.
1554	1554	1531 “Pharmacy”, a physical or electronic facility under the direction or supervision of a
1555	1555	1532registered pharmacist that is authorized to dispense prescription drugs and has entered into a
1556	1556	1533network contract with a pharmacy benefit manager or a carrier. 72 of 85
1557	1557	1534 “Pharmacy benefit manager”, a person, business or other entity, however organized, that
1558	1558	1535directly or through a subsidiary provides pharmacy benefit management services for prescription
1559	1559	1536drugs and devices on behalf of a health benefit plan sponsor, including, but not limited to, a self-
1560	1560	1537insurance plan, labor union or other third-party payer; provided, however, that pharmacy benefit
1561	1561	1538management services shall include, but not be limited to: (i) the processing and payment of
1562	1562	1539claims for prescription drugs; (ii) the performance of drug utilization review; (iii) the processing
1563	1563	1540of drug prior authorization requests; (iv) pharmacy contracting; (v) the adjudication of appeals or
1564	1564	1541grievances related to prescription drug coverage contracts; (vi) formulary administration; (vii)
1565	1565	1542drug benefit design; (viii) mail and specialty drug pharmacy services; (ix) cost containment; (x)
1566	1566	1543clinical, safety and adherence programs for pharmacy services; and (xi) managing the cost of
1567	1567	1544covered prescription drugs; provided further, that “pharmacy benefit manager” shall not include
1568	1568	1545a health benefit plan sponsor unless otherwise specified by the division.
1569	1569	1546 Section 2. (a) No person, business or other entity shall establish or operate as a pharmacy
1570	1570	1547benefit manager without obtaining a license from the division pursuant to this section. A license
1571	1571	1548may be granted only when the division is satisfied that the entity possesses the necessary
1572	1572	1549organization, background expertise, and financial integrity to supply the services sought to be
1573	1573	1550offered. A pharmacy benefit manager license shall be valid for a period of 3 years and shall be
1574	1574	1551renewable for additional 3-year periods. Initial application and renewal fees for the license shall
1575	1575	1552be established pursuant to section 3B of chapter 7.
1576	1576	1553 (b) A license granted pursuant to this section and any rights or interests therein shall not
1577	1577	1554be transferable. 73 of 85
1578	1578	1555 (c) A person, business or other entity licensed as a pharmacy benefit manager shall
1579	1579	1556submit data and reporting information to the center according to the standards and methods
1580	1580	1557specified by the center pursuant to section 10A of chapter 12C.
1581	1581	1558 (d) The division may issue or renew a license pursuant to this section, subject to
1582	1582	1559restrictions in order to protect the interests of consumers. Such restrictions may include: (i)
1583	1583	1560limiting the type of services that a license holder may provide; (ii) limiting the activities in which
1584	1584	1561the license holder may be engaged; or (iii) addressing conflicts of interest between pharmacy
1585	1585	1562benefit managers and health plan sponsors.
1586	1586	1563 (e) The division shall develop an application for licensure of pharmacy benefit managers
1587	1587	1564that shall include, but not be limited to: (i) the name of the applicant or pharmacy benefit
1588	1588	1565manager; (ii) the address and contact telephone number for the applicant or pharmacy benefit
1589	1589	1566manager; (iii) the name and address of the agent of the applicant or pharmacy benefit manager
1590	1590	1567for service of process in the commonwealth; (iv) the name and address of any person with
1591	1591	1568management or control over the applicant or pharmacy benefit manager; and (v) any audited
1592	1592	1569financial statements specific to the applicant or pharmacy benefit manager. An applicant or
1593	1593	1570pharmacy benefit manager shall report to the division any material change to the information
1594	1594	1571contained in its application, certified by an officer of the pharmacy benefit manager, within 30
1595	1595	1572days of such a change.
1596	1596	1573 (f) The division may suspend, revoke, refuse to issue or renew or place on probation a
1597	1597	1574pharmacy benefit manager license for cause, which shall include, but not be limited to: (i) the
1598	1598	1575applicant or pharmacy benefit manager engaging in fraudulent activity that is found by a court of
1599	1599	1576law to be a violation of state or federal law; (ii) the division receiving consumer complaints that 74 of 85
1600	1600	1577justify an action under this chapter to protect the health, safety and interests of consumers; (iii)
1601	1601	1578the applicant or pharmacy benefit manager failing to pay an application or renewal fee for a
1602	1602	1579license; (iv) the applicant or pharmacy benefit manager failing to comply with reporting
1603	1603	1580requirements of the center under section 10A of chapter 12C; or (v) the applicant pharmacy
1604	1604	1581benefit manager’s failing to comply with a requirement of this chapter.
1605	1605	1582 The division shall provide written notice to the applicant or pharmacy benefit manager
1606	1606	1583and advise in writing of the reason for any suspension, revocation, refusal to issue or renew or
1607	1607	1584placement on probation of a pharmacy benefit manager license under this chapter. A copy of the
1608	1608	1585notice shall be forwarded to the center. The applicant or pharmacy benefit manager may make
1609	1609	1586written demand upon the division within 30 days of receipt of such notification for a hearing
1610	1610	1587before the division to determine the reasonableness of the division’s action. The hearing shall be
1611	1611	1588held pursuant to chapter 30A.
1612	1612	1589 The division shall not suspend or cancel a license unless the division has first afforded
1613	1613	1590the pharmacy benefit manager an opportunity for a hearing pursuant to said chapter 30A.
1614	1614	1591 (g) If a person, business or other entity performs the functions of a pharmacy benefit
1615	1615	1592manager in violation of this chapter, the person, business or other entity shall be subject to a fine
1616	1616	1593of $5,000 per day for each day that the person, business or other entity is found to be in violation.
1617	1617	1594Penalties collected under this subsection shall be deposited into the Prescription Drug Cost
1618	1618	1595Assistance Trust Fund established in section 2BBBBBB of chapter 29.
1619	1619	1596 (h) A pharmacy benefit manager licensed under this section shall notify a health carrier
1620	1620	1597client in writing of any activity, policy, practice contract or arrangement of the pharmacy benefit 75 of 85
1621	1621	1598manager that directly or indirectly presents any conflict of interest with the pharmacy benefit
1622	1622	1599manager’s relationship with or obligation to the health carrier client.
1623	1623	1600 (i) The division shall adopt any written policies, procedures or regulations that the
1624	1624	1601division determines are necessary to implement this section.
1625	1625	1602 Section 3. (a) The commissioner may make an examination of the affairs of a pharmacy
1626	1626	1603benefit manager when the commissioner deems prudent but not less frequently than once every 3
1627	1627	1604years. The focus of the examination shall be to ensure that a pharmacy benefit manager is able to
1628	1628	1605meet its responsibilities under contracts with carriers licensed under chapters 175, 176A, 176B,
1629	1629	1606or 176G. The examination shall be conducted according to the procedures set forth in paragraph
1630	1630	1607(6) of section 4 of chapter 175.
1631	1631	1608 (b) The commissioner, a deputy or an examiner may conduct an on-site examination of
1632	1632	1609each pharmacy benefit manager in the commonwealth to thoroughly inspect and examine its
1633	1633	1610affairs.
1634	1634	1611 (c) The charge for each such examination shall be determined annually according to the
1635	1635	1612procedures set forth in paragraph (6) of section 4 of chapter 175.
1636	1636	1613 (d) Not later than 60 days following completion of the examination, the examiner in
1637	1637	1614charge shall file with the commissioner a verified written report of examination under oath.
1638	1638	1615Upon receipt of the verified report, the commissioner shall transmit the report to the pharmacy
1639	1639	1616benefit manager examined with a notice that shall afford the pharmacy benefit manager
1640	1640	1617examined a reasonable opportunity of not more than 30 days to make a written submission or
1641	1641	1618rebuttal with respect to any matters contained in the examination report. Within 30 days of the
1642	1642	1619end of the period allowed for the receipt of written submissions or rebuttals, the commissioner 76 of 85
1643	1643	1620shall consider and review the reports together with any written submissions or rebuttals and any
1644	1644	1621relevant portions of the examiner’s work papers and enter an order:
1645	1645	1622 (i) adopting the examination report as filed with modifications or corrections and, if the
1646	1646	1623examination report reveals that the pharmacy benefit manager is operating in violation of this
1647	1647	1624section or any regulation or prior order of the commissioner, the commissioner may order the
1648	1648	1625pharmacy benefit manager to take any action the commissioner considers necessary and
1649	1649	1626appropriate to cure such violation;
1650	1650	1627 (ii) rejecting the examination report with directions to examiners to reopen the
1651	1651	1628examination for the purposes of obtaining additional data, documentation or information and re-
1652	1652	1629filing pursuant to the above provisions; or
1653	1653	1630 (iii) calling for an investigatory hearing with not less than 20 days’ notice to the
1654	1654	1631pharmacy benefit manager for purposes of obtaining additional documentation, data, information
1655	1655	1632and testimony.
1656	1656	1633 (e) Notwithstanding any general or special law to the contrary, including clause Twenty-
1657	1657	1634sixth of section 7 of chapter 4 and chapter 66, the records of any such audit, examination or other
1658	1658	1635inspection and the information contained in the records, reports or books of any pharmacy
1659	1659	1636benefit manager examined pursuant to this section shall be confidential and open only to the
1660	1660	1637inspection of the commissioner, or the examiners and assistants. Access to such confidential
1661	1661	1638material may be granted by the commissioner to law enforcement officials of the commonwealth
1662	1662	1639or any other state or agency of the federal government at any time if the agency or office
1663	1663	1640receiving the information agrees in writing to keep such material confidential. Nothing in this
1664	1664	1641subsection shall be construed to prohibit the required production of such records, and 77 of 85
1665	1665	1642information contained in the reports of such company or organization before any court of the
1666	1666	1643commonwealth or any master or auditor appointed by any such court, in any criminal or civil
1667	1667	1644proceeding, affecting such pharmacy benefit manager, its officers, partners, directors or
1668	1668	1645employees. The final report of any such audit, examination or any other inspection by or on
1669	1669	1646behalf of the division of insurance shall be a public record.
1670	1670	1647 SECTION 57. (a) Notwithstanding any general or special law to the contrary, the
1671	1671	1648commonwealth health insurance connector authority, in consultation with the division of
1672	1672	1649insurance, shall report on the impact of pharmaceutical pricing on health care costs and outcomes
1673	1673	1650for ConnectorCare and non-group and small group plans offered through the connector and its
1674	1674	1651members.
1675	1675	1652 The report shall include, but not be limited to: (i) information on the differential between
1676	1676	1653drug list price and price net of rebates for plans offered and the impact of those differentials on
1677	1677	1654member premiums; (ii) the relationship between drug list price and member cost-sharing
1678	1678	1655requirements; (iii) the impact of drug price changes over time on premium and out-of-pocket
1679	1679	1656costs in plans authorized under section 3 of chapter 176J of the General Laws offered through the
1680	1680	1657commonwealth health insurance connector authority; (iv) trends in changes in drug list price and
1681	1681	1658price net of rebates by health plan; (v) an analysis of the impact of member out-of-pocket costs
1682	1682	1659on drug utilization and member experience; and (vi) an analysis of the impact of drug list price
1683	1683	1660and price net of rebates on member formulary access to drug. Data collected under this
1684	1684	1661subsection shall be protected as confidential and shall not be a public record under clause
1685	1685	1662Twenty-sixth of section 7 of chapter 4 of the General Laws or under chapter 66 of the General
1686	1686	1663Laws. 78 of 85
1687	1687	1664 The report shall be submitted to the joint committee on health care financing and the
1688	1688	1665house and senate committees on ways and means not later than July 1, 2025.
1689	1689	1666 (b) In fiscal year 2024, the amount required to be paid pursuant to the last paragraph of
1690	1690	1667section 6 of chapter 6D of the General Laws shall be increased by $500,000; provided, however,
1691	1691	1668that said $500,000 shall be provided to the commonwealth health insurance connector authority
1692	1692	1669not later than March 14, 2024 for data collection and analysis costs associated with the report
1693	1693	1670required by this section.
1694	1694	1671 SECTION 58. Notwithstanding any general or special law to the contrary, there shall be a
1695	1695	1672special commission to examine the feasibility of: (i) establishing a system for the bulk
1696	1696	1673purchasing and distribution of pharmaceutical products with a significant public health benefit
1697	1697	1674and the potential for significant health care cost savings for consumers through overall increased
1698	1698	1675purchase capacity; and (ii) making bulk purchase pricing information available to purchasers in
1699	1699	1676other states.
1700	1700	1677 The commission shall consist of: the commissioner of public health or a designee, who
1701	1701	1678shall serve as chair; the executive director of the group insurance commission or a designee; the
1702	1702	1679chief of pharmacy of the state office for pharmacy services; the MassHealth director of
1703	1703	1680pharmacy; the secretary of technology services and security; and 9 members to be appointed by
1704	1704	1681the commissioner of public health, 2 of whom shall be health care economists, 1 of whom shall
1705	1705	1682be an expert in health law and policy innovation, 1 of whom shall be an academic with relevant
1706	1706	1683expertise in the field, 1 of whom shall be a representative from a community health center, 1 of
1707	1707	1684whom shall be the chief executive officer of a hospital licensed in the commonwealth, 1 of
1708	1708	1685whom shall be a representative of the Massachusetts Association of Health Plans, Inc., 1 of 79 of 85
1709	1709	1686whom shall be a representative of Blue Cross Blue Shield of Massachusetts, Inc. and 1 of whom
1710	1710	1687shall be a member of the public with experience with health care and consumer protection.
1711	1711	1688 The commission shall hold not less than 3 public hearings in different geographic areas of
1712	1712	1689the commonwealth, accept input from the public and solicit expert testimony from individuals
1713	1713	1690representing health insurance carriers, pharmaceutical companies, independent and chain
1714	1714	1691pharmacies, hospitals, municipalities, health care practitioners, health care technology
1715	1715	1692professionals, community health centers, substance abuse disorder providers, public health
1716	1716	1693educational institutions and other experts identified by the commission.
1717	1717	1694 The commission shall consider: (i) the process by which the commonwealth could make
1718	1718	1695bulk purchases of pharmaceutical products with a significant public health benefit and the
1719	1719	1696potential for significant health care cost savings to consumers; (ii) the process by which both
1720	1720	1697governmental and nongovernmental entities may participate in a collaborative to purchase
1721	1721	1698pharmaceutical products with a significant public health benefit and the potential for significant
1722	1722	1699health care cost savings; (iii) the feasibility of developing an electronic information interchange
1723	1723	1700system to exchange bulk purchase price information with partnering states; (iv) potential sources
1724	1724	1701of funding available to implement bulk purchases; (v) potential cost savings of bulk purchases to
1725	1725	1702the commonwealth or other participating nongovernmental entities; (vi) the feasibility of
1726	1726	1703partnering with the federal government or other states in the New England region; and (vii) any
1727	1727	1704other factors that the commission deems relevant.
1728	1728	1705 The commission shall file a report of its analysis, along with any recommended
1729	1729	1706legislation, if any, to the clerks of the senate and house of representatives, the house and senate
1730	1730	1707committees on ways and means, the joint committee on health care financing, the joint 80 of 85
1731	1731	1708committee on public health, the joint committee on elder affairs and the joint committee on
1732	1732	1709mental health, substance abuse and recovery not later than September 1, 2024.
1733	1733	1710 SECTION 59. (a) As used in this section, the following words shall have the following
1734	1734	1711meanings unless the context clearly requires otherwise:
1735	1735	1712 “Chain pharmacist”, a pharmacist employed by a retail drug organization operating not
1736	1736	1713less than 10 retail drug stores within the commonwealth under section 39 of chapter 112 of the
1737	1737	1714General Laws.
1738	1738	1715 “Independent pharmacist”, a pharmacist actively engaged in the business of retail
1739	1739	1716pharmacy and employed in an organization of not more than 9 registered retail drugstores in the
1740	1740	1717commonwealth under said section 39 of said chapter 112 that employs not more than a total of
1741	1741	171820 full-time pharmacists.
1742	1742	1719 (b) There shall be a task force to: (i) review the drug supply chain and reimbursement
1743	1743	1720structures including, but not limited to: (A) plan and pharmacy benefit manager reimbursements
1744	1744	1721to pharmacies; (B) wholesaler prices to pharmacies; (C) pharmacy services administrative
1745	1745	1722organization fees and contractual relationships with pharmacies; and (D) drug manufacturer
1746	1746	1723prices to wholesalers; (ii) review ways to recognize the unique challenges of small and
1747	1747	1724independent pharmacies; (iii) identify methods to increase pricing transparency throughout the
1748	1748	1725supply chain; (iv) make recommendations on the use of multiple maximum allowable costs lists
1749	1749	1726and their frequency of use for mail order products; (v) review the utilization of maximum
1750	1750	1727allowable costs lists or similar reimbursement structures established by a pharmacy benefit
1751	1751	1728manager or payer; (vi) review the availability of drugs to independent and chain pharmacies on
1752	1752	1729the maximum allowable cost list or any similar reimbursement structures established by a 81 of 85
1753	1753	1730pharmacy benefit manager or payer; (vii) review the pharmacy acquisition cost from national or
1754	1754	1731regional wholesalers that serve pharmacies compared to the reimbursement amount provided
1755	1755	1732through a maximum allowable cost list or any similar reimbursement structures established by a
1756	1756	1733pharmacy benefit manager or payer and the conditions under which an adjustment to a
1757	1757	1734reimbursement is appropriate; (viii) review the timing of pharmacy purchases of products and the
1758	1758	1735relative risk of list price changes related to the timing of dispensing the products; (ix) assess
1759	1759	1736ways to increase transparency for chain and independent pharmacists to understand the
1760	1760	1737methodology used by a pharmacy benefit manager or payer to develop a maximum allowable
1761	1761	1738cost list or any similar reimbursement structure established by the pharmacy benefit manager or
1762	1762	1739payer; (x) assess the prevalence and appropriateness of pharmacy benefit managers requiring, or
1763	1763	1740using financial incentives or penalties to incentivize, customer use of pharmacies with whom the
1764	1764	1741pharmacy benefit manager has an ownership or financial interest; (xi) examine the impact of the
1765	1765	1742merger or consolidation of pharmacy benefit managers and health carrier clients on drug costs;
1766	1766	1743(xii) review current appeals processes for a chain or independent pharmacist to request an
1767	1767	1744adjustment on a reimbursement subject to a maximum allowable cost list or any similar
1768	1768	1745reimbursement structure established by a pharmacy benefit manager or payer; and (xiii) evaluate
1769	1769	1746the effect of differences between pharmacy benefit manager payments to pharmacies and charges
1770	1770	1747made to health carrier clients on drug price.
1771	1771	1748 (c) The task force shall consist of: the commissioner of insurance or a designee, who shall
1772	1772	1749serve as chair; and 9 members to be appointed by the commissioner, 2 of whom shall be
1773	1773	1750independent pharmacists employed in the independent pharmacy setting or representatives of
1774	1774	1751independent pharmacies, 2 of whom shall be chain pharmacists employed in the chain pharmacy
1775	1775	1752setting or representatives of chain pharmacies, 2 of whom shall be representatives of a pharmacy 82 of 85
1776	1776	1753benefit managers or payers who manage their own pharmacy benefit services, 1 of whom shall
1777	1777	1754represent the Massachusetts Association of Health Plans, Inc., 1 of whom shall represent Blue
1778	1778	1755Cross Blue Shield of Massachusetts, Inc. and 1 of whom shall be a representative of wholesalers
1779	1779	1756or pharmacy services administrative organizations. If more than 1 independent pharmacist is
1780	1780	1757appointed, each appointee shall represent a distinct practice setting. If more than 1 chain
1781	1781	1758pharmacist is appointed, each appointee shall represent a distinct practice setting. A pharmacy
1782	1782	1759benefit manager or payer appointed to the task force shall not be co-owned or have any
1783	1783	1760ownership relationship with any other payer, pharmacy benefit manager or chain pharmacist also
1784	1784	1761appointed to the task force.
1785	1785	1762 (d) The commissioner shall file the task force’s findings with the clerks of the house of
1786	1786	1763representatives and the senate, the joint committee on health care financing and the house and
1787	1787	1764senate committees on ways and means not later than December 1, 2024.
1788	1788	1765 SECTION 60. The health policy commission shall consult with relevant stakeholders,
1789	1789	1766including, but not limited to, consumers, consumer advocacy organizations, organizations
1790	1790	1767representing people with disabilities and chronic health conditions, providers, provider
1791	1791	1768organizations, payers, pharmaceutical manufacturers, pharmacy benefit managers and health care
1792	1792	1769economists and other academics, to assist in the development and periodic review of regulations
1793	1793	1770to implement section 21 of chapter 6D of the General Laws, including, but not limited to: (i)
1794	1794	1771establishing the criteria and processes for identifying the proposed value of an eligible drug as
1795	1795	1772defined in said section 21 of said chapter 6D; and (ii) determining the appropriate price increase
1796	1796	1773for a public health essential drug as described within the definition of eligible drug in said
1797	1797	1774section 21 of said chapter 6D. 83 of 85
1798	1798	1775 The commission shall hold its first public outreach not more than 45 days after the
1799	1799	1776effective date of this act and shall, to the extent possible, ensure fair representation and input
1800	1800	1777from a diverse array of stakeholders.
1801	1801	1778 SECTION 61. Annually, each carrier shall report to the division of insurance the drugs
1802	1802	1779selected to be provided with no or limited cost-sharing under section 17T of chapter 32A of the
1803	1803	1780General Laws, section 10R of chapter 118E of the General Laws, section 47UU of chapter 175 of
1804	1804	1781the General Laws, section 8VV of chapter 176A of the General Laws, section 4VV of chapter
1805	1805	1782176B of the General Laws and section 4NN of chapter 176G of the General Laws. The division
1806	1806	1783of insurance shall consult with the health policy commission and the center for health and
1807	1807	1784information analysis to review the drugs to verify that the selected drugs meet the criteria
1808	1808	1785identified in said section 17T of said chapter 32A, said section 10R of said chapter 118E, said
1809	1809	1786section 47UU of said chapter 175, said section 8VV of said chapter 176A, said section 4VV of
1810	1810	1787said chapter 176B and said section 4NN of said chapter 176G. If a selected drug shall be deemed
1811	1811	1788by the division to not meet the criteria, the division may require a different drug to be selected.
1812	1812	1789The division shall disclose the list of drugs selected by each entity annually on the division’s
1813	1813	1790website.
1814	1814	1791 SECTION 62. Notwithstanding subsection (b) of section 15A of chapter 6D of the
1815	1815	1792General Laws, for the purposes of providing early notice under said section 15A of said chapter
1816	1816	17936D, the health policy commission shall determine a significant price increase for a generic drug
1817	1817	1794to be defined as a generic drug priced at $100 or more per wholesale acquisition cost unit that
1818	1818	1795increases in cost by 100 per cent or more during any 12-month period.
1819	1819	1796 SECTION 63. Section 62 is hereby repealed. 84 of 85
1820	1820	1797 SECTION 64. The health policy commission, in consultation with the department of
1821	1821	1798public health, the office of Medicaid, the group insurance commission and the division of
1822	1822	1799insurance, shall study and analyze health insurance payer, including public and private payer,
1823	1823	1800specialty pharmacy networks in the commonwealth. The study shall include: (i) a description of
1824	1824	1801the type of specialty drugs most often provided by specialty pharmacies; (ii) the impact of
1825	1825	1802existing health insurance payers’ specialty pharmacy networks on patient access, availability of
1826	1826	1803clinical support, continuity of care, safety, quality, cost sharing and health care costs; and (iii)
1827	1827	1804any recommendations for increasing patient access to and choice of specialty drugs, maintaining
1828	1828	1805high-quality specialty pharmacy standards and meeting the commonwealth’s health care cost
1829	1829	1806containment goals.
1830	1830	1807 The commission shall submit a report of its findings and recommendations to the clerks
1831	1831	1808of the senate and house of representatives, the senate and house committees on ways and means,
1832	1832	1809the joint committee on health care financing and the joint committee on public health not later
1833	1833	1810than July 1, 2024.
1834	1834	1811 SECTION 65. The regulations required by subsection (d) of section 39K of chapter 112
1835	1835	1812of the General Laws shall be promulgated not later than December 31, 2023.
1836	1836	1813 SECTION 66. Sections 21 and 39 shall take effect on July 1, 2024.
1837	1837	1814 SECTION 67. Sections 41, 44, 45, 47, 48, 52 and 61 shall take effect as of July 1, 2025.
1838	1838	1815 SECTION 68. Section 43 shall take effect on April 1, 2024.
1839	1839	1816 SECTION 69. Section 54 shall take effect on July 1, 2024.
1840	1840	1817 SECTION 70. Section 56 shall take effect on March 30, 2024. 85 of 85
1841	1841	1818 SECTION 71. Section 63 shall take effect on January 1, 2025.