Massachusetts 2023-2024 Regular Session

Massachusetts House Bill H4891 Compare Versions

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1	1	HOUSE . . . . . . . No. 4891
2	2	The Commonwealth of Massachusetts
3	3	______________________________________
4	4
5	5	HOUSE OF REPRESENTATIVES, July 22, 2024.
6	6	The committee on Ways and Means, to whom was referred the Senate
7	7	Bill relative to pharmaceutical access, costs and transparency (Senate, No.
8	8	2520), reports recommending that the same ought to pass with
9	9	amendments striking all after the enacting clause and inserting in place
10	10	thereof the text contained in House document numbered 4891; and by
11	11	striking out the title and inserting in place thereof the following title: “ An
12	12	Act promoting access and affordability of prescription drugs.”.
13	13	For the committee,
14	14	AARON MICHLEWITZ. 1 of 58
15	15	HOUSE . . . . . . . . . . . . . . . No. 4891
16	16	Text of amendments, recommended by the committee on Ways and Means, to the Senate Bill
17	17	relative to pharmaceutical access, costs and transparency (Senate, No. 2520). July 22, 2024.
18	18	The Commonwealth of Massachusetts
19	19	_______________
20	20	In the One Hundred and Ninety-Third General Court
21	21	(2023-2024)
22	22	_______________
23	23	By striking out all after the enacting clause and inserting in place thereof the following:–
24	24	1 SECTION 1. Section 1 of chapter 6D, as appearing in the 2022 Official Edition, is hereby
25	25	2amended by striking out the definition of “Payer” and inserting in place thereof the following
26	26	3definition:-
27	27	4 “Payer”, any entity, other than an individual, that pays providers for the provision of
28	28	5health care services, including self-insured plans to the extent allowed under the federal
29	29	6Employee Retirement Income Security Act of 1974.
30	30	7 SECTION 2. Said section 1 of said chapter 6D, as so appearing, is hereby further
31	31	8amended by inserting after the definition of “Performance penalty” the following 2 definitions:-
32	32	9 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
33	33	10preparation, propagation, compounding, conversion or processing of prescription drugs, directly
34	34	11or indirectly, by extraction from substances of natural origin, independently by means of
35	35	12chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
36	36	13repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
37	37	14“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed 2 of 58
38	38	15under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
39	39	16chapter 112.
40	40	17 “Pharmacy benefit manager”, as defined in section 1 of chapter 176Y.
41	41	18 SECTION 3. Said chapter 6D is hereby further amended by inserting after section 3 the
42	42	19following section:-
43	43	20 Section 3A. (a) There is hereby established within the commission an office for
44	44	21pharmaceutical policy and analysis, hereinafter referred to as the office. The office shall: (i)
45	45	22analyze pharmaceutical spending data and information collected by the commission under this
46	46	23chapter and other agencies of the commonwealth pursuant to subsection (b); (ii) produce reports
47	47	24and analyses of issues related to the access, affordability of and spending on pharmaceutical
48	48	25drugs in the commonwealth pursuant to subsection (c); (iii) analyze records related to
49	49	26pharmaceutical pricing disclosed to the commission pursuant to section 8A and assist the
50	50	27commission in identifying proposed supplemental rebates for eligible drugs under said section
51	51	288A; and (iv) advise the general court and state agencies on matters related to pharmaceutical
52	52	29drug policy.
53	53	30 (b) The office shall analyze pharmaceutical spending data collected by the commission
54	54	31and other agencies of the commonwealth, including pharmaceutical spending data collected by
55	55	32the center under sections 8 to 10B, inclusive, of chapter 12C, and pharmaceutical spending data
56	56	33available through publicly available sources. As part of its analysis, the office shall conduct an
57	57	34annual survey of payers on pharmaceutical access and plan design, including tiering, cost-sharing
58	58	35and other utilization management techniques employed by payers; provided, however, that any 3 of 58
59	59	36confidential data shall not be a public record and shall be exempt from disclosure pursuant to
60	60	37clause Twenty-sixth of section 7 of chapter 4 and section 10 of chapter 66.
61	61	38 (c)(1) The office shall produce an annual report on issues related to access, affordability
62	62	39and spending on pharmaceutical drugs in the commonwealth and other reports as the office may
63	63	40produce from time to time. The annual report shall address trends and underlying factors for
64	64	41pharmaceutical drug spending, including an analysis of: (i) prices and utilization; (ii) drugs or
65	65	42categories of drugs with the highest impact on spending; (iii) trends in patient out-of-pocket
66	66	43spending; and (iv) access and affordability issues for patients with rare diseases and chronic
67	67	44diseases; provided, that any analysis of a drug prescribed to treat a rare disease, or that is
68	68	45otherwise designated as a first-in-class drug, shall be conducted pursuant to paragraph (3). The
69	69	46report shall include any recommendations for strategies to mitigate pharmaceutical spending
70	70	47growth, promote affordability and enhance pharmaceutical access.
71	71	48 (2) The annual report shall be based on factors, including, but not limited to: (i) drug
72	72	49pricing; (ii) the impact of aggregate manufacturer rebates, discounts and other price concessions
73	73	50on net drug pricing; (iii) patient cost-sharing such as deductibles, coinsurance, copayments or
74	74	51similar charges paid by patients for drugs; (iv) the impacts of aggregate rebates, discounts and
75	75	52other price concessions on such cost-sharing; and (v) the impacts of utilization management
76	76	53techniques on pharmaceutical access employed by payers, including tiering, prior authorization
77	77	54and step therapy. The annual report shall be informed by: (A) the office’s analysis of information
78	78	55provided at the annual cost trends hearing by providers, provider organizations and payers; (B)
79	79	56data collected by the center under sections 8 to 10B, inclusive, of chapter 12C; and (C) any other
80	80	57information available to the commission that is necessary to fulfill its duties under this section, as
81	81	58further defined in regulations promulgated by the commission. 4 of 58
82	82	59 (3) The office shall consult with the rare disease advisory council established pursuant to
83	83	60section 241 of chapter 111, and other stakeholders as determined by the office, for any analysis
84	84	61the office performs of a drug that is prescribed to treat a rare disease or is otherwise designated
85	85	62as a first-in-class drug by the United States Food and Drug Administration’s Center for Drug
86	86	63Evaluation and Research. Such analysis shall include:
87	87	64 (i) the disease treated by the drug;
88	88	65 (ii) the severity of disease treated by the drug;
89	89	66 (iii) the unmet medical need associated with the disease treated by the drug;
90	90	67 (iv) the impact of particular coverage, cost-sharing, tiering, utilization management, prior
91	91	68authorization, medication therapy management or other utilization management policies on
92	92	69access to the drug and on patients’ adherence to the treatment regimen prescribed or otherwise
93	93	70recommended by their health care provider;
94	94	71 (v) an assessment of the benefits and risks of the drug for patients;
95	95	72 (vi) whether patients who need treatment from or a consultation with a rare disease
96	96	73specialist or a specialist in the disease being treated by the first-in-class drug have adequate
97	97	74access and, if not, what factors are causing the limited access; and
98	98	75 (vii) the demographic and the clinical description of patient populations.
99	99	76 (4) Annually, not later than September 1, the report shall be submitted to the chairs of the
100	100	77house and senate committees on ways and means and the chairs of the joint committee on health
101	101	78care financing and shall be published and made available to the public. 5 of 58
102	102	79 (d) The office shall analyze records related to pharmaceutical pricing disclosed to the
103	103	80commission pursuant to section 8A and assist the commission in identifying proposed
104	104	81supplemental rebates for eligible drugs under said section 8A. The office’s analysis of such
105	105	82records shall consider: (i) the effectiveness of the drug in treating the conditions for which it is
106	106	83prescribed; (ii) improvements to a patient’s health, quality of life or overall health outcomes; and
107	107	84(iii) the likelihood that use of the drug will reduce the need for other medical care, including
108	108	85hospitalization.
109	109	86 (e) The office may consult with external experts or other third-party entities when the
110	110	87office lacks the specific scientific, medical or technical expertise necessary for the performance
111	111	88of its responsibilities under this section; provided, however, that the commission shall disclose
112	112	89when such external expert or third-party entity contributes to its analysis and reporting and the
113	113	90identity of such external expert or third-party entity.
114	114	91 SECTION 4. Section 4 of said chapter 6D, as appearing in the 2022 Official Edition, is
115	115	92hereby amended by striking out, in line 8, the word “manufacturers” and inserting in place
116	116	93thereof the following words:- manufacturing companies, pharmacy benefit managers.
117	117	94 SECTION 5. Said chapter 6D is hereby further amended by striking out section 6, as so
118	118	95appearing, and inserting in place thereof the following section:-
119	119	96 Section 6. (a) For the purposes of this section, “non-hospital provider organization” shall
120	120	97mean a provider organization required to register under section 11 that is: (i) a non-hospital-
121	121	98based physician practice with not less than $500,000,000 in annual gross patient service revenue;
122	122	99(ii) a clinical laboratory; (iii) an imaging facility; or (iv) a network of affiliated urgent care
123	123	100centers. 6 of 58
124	124	101 (b) Each acute hospital, ambulatory surgical center, non-hospital provider organization,
125	125	102pharmaceutical manufacturing company and pharmacy benefit manager shall pay to the
126	126	103commonwealth an amount for the estimated expenses of the commission.
127	127	104 (c) The assessed amount for hospitals, ambulatory surgical centers and non-hospital
128	128	105provider organizations shall be not less than 30 per cent nor more than 40 per cent of the amount
129	129	106appropriated by the general court for the expenses of the commission minus amounts collected
130	130	107from: (i) filing fees; (ii) fees and charges generated by the commission; and (iii) federal matching
131	131	108revenues received for these expenses or received retroactively for expenses of predecessor
132	132	109agencies; provided, that non-hospital provider organizations shall be assessed not less than 3 per
133	133	110cent nor more than 8 per cent of the assessed amount for hospitals, ambulatory surgical centers
134	134	111and non-hospital provider organizations. Each acute hospital, ambulatory surgical center and
135	135	112non-hospital provider organization shall pay such assessed amount multiplied by the ratio of the
136	136	113hospital’s, ambulatory surgical center’s or non-hospital provider organization’s gross patient
137	137	114service revenues to the total gross patient service revenues of all such hospitals, ambulatory
138	138	115surgical centers and non-hospital provider organizations. Each acute hospital, ambulatory
139	139	116surgical center and non-hospital provider organization shall make a preliminary payment to the
140	140	117commission on October 1 of each year in an amount equal to 1/2 of the previous year’s total
141	141	118assessment. Thereafter, each hospital, ambulatory surgical center and non-hospital provider
142	142	119organization shall pay, within 30 days’ notice from the commission, the balance of the total
143	143	120assessment for the current year based upon its most current projected gross patient service
144	144	121revenue. The commission shall subsequently adjust the assessment for any variation in actual and
145	145	122estimated expenses of the commission and for changes in hospital, ambulatory surgical center
146	146	123and non-hospital provider organization gross patient service revenue. Such estimated and actual 7 of 58
147	147	124expenses shall include an amount equal to the cost of fringe benefits and indirect expenses, as
148	148	125established by the comptroller under section 5D of chapter 29. In the event of late payment by
149	149	126any such hospital, ambulatory surgical center or non-hospital provider organization, the treasurer
150	150	127shall advance the amount of due and unpaid funds to the commission prior to the receipt of such
151	151	128monies in anticipation of such revenues up to the amount authorized in the then current budget
152	152	129attributable to such assessments and the commission shall reimburse the treasurer for such
153	153	130advances upon receipt of such revenues. This section shall not apply to any state institution or to
154	154	131any acute hospital which is operated by a city or town.
155	155	132 (d) The assessed amount for pharmaceutical manufacturing companies shall be not less
156	156	133than 5 per cent nor more than 10 per cent of the amount appropriated by the general court for the
157	157	134expenses of the commission minus amounts collected from: (i) filing fees; (ii) fees and charges
158	158	135generated by the commission; and (iii) federal matching revenues received for these expenses or
159	159	136received retroactively for expenses of predecessor agencies. Each pharmaceutical manufacturing
160	160	137company shall pay such assessed amount multiplied by the ratio of MassHealth’s net spending
161	161	138for the manufacturer’s prescription drugs based on the manufacturer labeler codes used in the
162	162	139MassHealth rebate program to MassHealth’s total pharmacy spending.
163	163	140 (e) The assessed amount for pharmacy benefit managers shall be not less than 5 per cent
164	164	141nor more than 10 per cent of the amount appropriated by the general court for the expenses of the
165	165	142commission minus amounts collected from: (i) filing fees; (ii) fees and charges generated by the
166	166	143commission; and (iii) federal matching revenues received for these expenses or received
167	167	144retroactively for expenses of predecessor agencies. Each pharmacy benefit manager shall pay
168	168	145such assessed amount multiplied by the ratio of the aggregate revenues of the pharmacy benefit
169	169	146manager attributed to residents of the commonwealth for whom it manages pharmaceutical 8 of 58
170	170	147benefits on behalf of carriers to the total of all such revenues generated by all pharmacy benefit
171	171	148managers attributed to residents of the commonwealth for whom they manage pharmaceutical
172	172	149benefits on behalf of carriers.
173	173	150 SECTION 6. Section 8 of said chapter 6D, as so appearing, is hereby amended by
174	174	151inserting after the word “organization”, in lines 6 and 7, the following words:- , pharmacy benefit
175	175	152manager, pharmaceutical manufacturing company.
176	176	153 SECTION 7. Said section 8 of said chapter 6D, as so appearing, is hereby further
177	177	154amended by inserting after the word “organizations”, in line 15, the following words:- ,
178	178	155pharmacy benefit managers, pharmaceutical manufacturing companies.
179	179	156 SECTION 8. Said section 8 of said chapter 6D, as so appearing, is hereby further
180	180	157amended by striking out, in lines 33 and 34, the words “and (xi) any witness identified by the
181	181	158attorney general or the center” and inserting in place thereof the following words:- (xi) not less
182	182	159than 2 representatives of the pharmacy benefit management industry; (xii) not less than 3
183	183	160representatives of pharmaceutical manufacturing companies, 1 of whom shall be a representative
184	184	161of a publicly traded company that manufactures specialty drugs, 1 of whom shall be a
185	185	162representative of a company that manufacturers generic drugs and 1 of whom shall be a
186	186	163representative of a company that has been in existence for fewer than 10 years; and (xiii) any
187	187	164witness identified by the attorney general or the commission.
188	188	165 SECTION 9. Said section 8 of said chapter 6D, as so appearing, is hereby further
189	189	166amended by striking out, in line 49, the first time it appears, the word “and”.
190	190	167 SECTION 10. Said section 8 of said chapter 6D, as so appearing, is hereby further
191	191	168amended by inserting after the word “commission”, in line 60, the first time it appears, the 9 of 58
192	192	169following words:- ; (iii) in the case of pharmacy benefit managers and pharmaceutical
193	193	170manufacturing companies, testimony concerning factors underlying prescription drug costs and
194	194	171price increases, the impact of aggregate manufacturer rebates, discounts and other price
195	195	172concessions on net pricing; provided, however, that such testimony shall be suitable for public
196	196	173release and not likely to compromise the financial, competitive or proprietary nature of any
197	197	174information or data; and (iv) any other matters as determined by the commission.
198	198	175 SECTION 11. Subsection (g) of said section 8 of said chapter 6D, as so appearing, is
199	199	176hereby amended by striking out the second sentence and inserting in place thereof the following
200	200	177sentence:- The report shall be based on the commission’s analysis of information provided at the
201	201	178hearings by witnesses, providers, provider organizations, carriers, pharmacy benefit managers
202	202	179and pharmaceutical manufacturing companies, registration data collected pursuant to section 11,
203	203	180data collected or analyzed by the center pursuant to sections 8 to 10B, inclusive, of chapter 12C
204	204	181and any other available information, as defined in regulations promulgated by the commission,
205	205	182that the commission considers necessary to fulfill its duties under this section.
206	206	183 SECTION 12. Section 9 of said chapter 6D, as so appearing, is hereby amended by
207	207	184inserting after the word “organization”, in line 72, the following words:- , pharmacy benefit
208	208	185manager, pharmaceutical manufacturing company.
209	209	186 SECTION 13. Said section 9 of said chapter 6D, as so appearing, is hereby further
210	210	187amended by inserting after the word “organizations”, in line 82, the following words:- ,
211	211	188pharmacy benefit managers, pharmaceutical manufacturing companies.
212	212	189 SECTION 14. Said chapter 6D is hereby further amended by adding the following
213	213	190section:- 10 of 58
214	214	191 Section 22. Every 2 years, the commission, in consultation with the center, the group
215	215	192insurance commission, the office of Medicaid and the division of insurance, shall evaluate the
216	216	193impact of section 17T of chapter 32A, section 10R of chapter 118E, section 47VV of chapter
217	217	194175, section 8WW of chapter 176A, section 4WW of chapter 176B and section 4OO of chapter
218	218	195176G on the effects of capping co-payments on health care costs, including premiums,
219	219	196pharmaceutical spending, aggregate rebates, cost-sharing, drug treatment utilization and
220	220	197adherence, incidence of related acute events and health equity. Biennially, not later than
221	221	198November 30, the commission shall file a report of its findings with the clerks of the house of
222	222	199representatives and senate, the chairs of the joint committee on public health, the chairs of the
223	223	200joint committee on health care financing and the chairs of house and senate committees on ways
224	224	201and means.
225	225	202 SECTION 15. Section 1 of chapter 12C of the General Laws, as appearing in the 2022
226	226	203Official Edition, is hereby amended by inserting after the definition of “Dispersed service area”
227	227	204the following definition:-
228	228	205 “Drug rebate”, any: (i) negotiated price concessions, whether described as a rebate or
229	229	206otherwise, including, but not limited to, base price concessions, and reasonable estimates of any
230	230	207price protection rebates and performance-based price concessions that may accrue, directly or
231	231	208indirectly, to a carrier, pharmacy benefit manager or other party on a carrier’s behalf during a
232	232	209carrier’s plan year from a pharmaceutical manufacturing company, dispensing pharmacy or other
233	233	210party to the transaction based on the amounts the carrier received in the prior quarter or
234	234	211reasonably expects to receive in the current quarter; and (ii) reasonable estimates of any price
235	235	212concessions, fees and other administrative costs that are passed through or are reasonably
236	236	213anticipated to be passed through to the carrier, pharmacy benefit manager or other party on the 11 of 58
237	237	214carrier’s behalf and that serve to reduce the carrier’s prescription drug liabilities for the plan year
238	238	215based on the amounts the carrier received in the prior quarter or reasonably expects to receive in
239	239	216the current quarter.
240	240	217 SECTION 16. Said section 1 of said chapter 12C, as so appearing, is hereby further
241	241	218amended by inserting after the definition of “Patient-centered medical home” the following 3
242	242	219definitions:-
243	243	220 “Payer”, any entity, other than an individual, that pays providers for the provision of
244	244	221health care services, including self-insured plans to the extent allowed under the federal
245	245	222Employee Retirement Income Security Act of 1974.
246	246	223 “Pharmaceutical manufacturing company”, an entity engaged in the: (i) production,
247	247	224preparation, propagation, compounding, conversion or processing of prescription drugs, directly
248	248	225or indirectly, by extraction from substances of natural origin, independently by means of
249	249	226chemical synthesis or by a combination of extraction and chemical synthesis; or (ii) packaging,
250	250	227repackaging, labeling, relabeling or distribution of prescription drugs; provided, however, that
251	251	228“pharmaceutical manufacturing company” shall not include a wholesale drug distributor licensed
252	252	229under section 36B of chapter 112 or a retail pharmacist registered under section 39 of said
253	253	230chapter 112.
254	254	231 “Pharmacy benefit manager”, as defined in section 1 of chapter 176Y.
255	255	232 SECTION 17. Said section 1 of said chapter 12C, as so appearing, is hereby further
256	256	233amended by adding the following definition:- 12 of 58
257	257	234 “Wholesale acquisition cost”, the cost of a prescription drug as defined in 42 U.S.C.
258	258	235section 1395w-3a(c)(6)(B).
259	259	236 SECTION 18. Section 3 of said chapter 12C, as so appearing, is hereby amended by
260	260	237inserting after the word “organizations”, in lines 13 and 14, the following words:- , pharmacy
261	261	238benefit managers, pharmaceutical manufacturing companies.
262	262	239 SECTION 19. Said section 3 of said chapter 12C, as so appearing, is hereby further
263	263	240amended by inserting, after the word “provider”, in line 24, the following words:- , pharmacy
264	264	241benefit manager, pharmaceutical manufacturing company.
265	265	242 SECTION 20. Section 5 of said chapter 12C, as so appearing, is hereby amended by
266	266	243inserting after the word “organizations”, in line 11, the following words:- , pharmacy benefit
267	267	244managers, pharmaceutical manufacturing companies.
268	268	245 SECTION 21. Said section 5 of said chapter 12C, as so appearing, is hereby further
269	269	246amended by inserting after the word “providers”, in line 15, the following words:- , affected
270	270	247pharmacy benefit managers, affected pharmaceutical manufacturing companies.
271	271	248 SECTION 22. Said chapter 12C is hereby further amended by striking out section 7, as so
272	272	249appearing, and inserting in place thereof the following section:-
273	273	250 Section 7. (a) For the purposes of this section, “non-hospital provider organization” shall
274	274	251mean a provider organization required to register under section 11 under chapter 6D that is: (i) a
275	275	252non-hospital-based physician practice with not less than $500,000,000 in annual gross patient
276	276	253service revenue; (ii) a clinical laboratory; (iii) an imaging facility; or (iv) a network of affiliated
277	277	254urgent care centers. 13 of 58
278	278	255 (b) Each acute hospital, ambulatory surgical center and non-hospital provider
279	279	256organization shall pay to the commonwealth an amount for the estimated expenses of the center
280	280	257and for the other purposes described in this chapter which shall include any transfer made to the
281	281	258Community Hospital Reinvestment Trust Fund established in section 2TTTT of chapter 29.
282	282	259 (c) The assessed amount for hospitals, ambulatory surgical centers and non-hospital
283	283	260provider organizations shall be not less than 30 per cent nor more than 40 per cent of the amount
284	284	261appropriated by the general court for the expenses of the center and for the other purposes
285	285	262described in this chapter which shall include any transfer made to the Community Hospital
286	286	263Reinvestment Trust Fund established in section 2TTTT of chapter 29 minus amounts collected
287	287	264from: (i) filing fees; (ii) fees and charges generated by the center’s publication or dissemination
288	288	265of reports and information; and (iii) federal matching revenues received for these expenses or
289	289	266received retroactively for expenses of predecessor agencies; provided, that non-hospital provider
290	290	267organizations shall be assessed not less than 3 per cent nor more than 8 per cent of the assessed
291	291	268amount for hospitals, ambulatory surgical centers and non-hospital provider organizations. Each
292	292	269acute hospital, ambulatory surgical center and non-hospital provider organization shall pay such
293	293	270assessed amount multiplied by the ratio of the hospital’s, ambulatory surgical center’s or non-
294	294	271hospital provider organization’s gross patient service revenues to the total gross patient services
295	295	272revenues of all such hospitals, ambulatory surgical centers and non-hospital provider
296	296	273organizations. Each acute hospital, ambulatory surgical center and non-hospital provider
297	297	274organization shall make a preliminary payment to the center on October 1 of each year in an
298	298	275amount equal to 1/2 of the previous year’s total assessment. Thereafter, each hospital,
299	299	276ambulatory surgical center and non-hospital provider organization shall pay, within 30 days’
300	300	277notice from the center, the balance of the total assessment for the current year based upon its 14 of 58
301	301	278most current projected gross patient service revenue. The center shall subsequently adjust the
302	302	279assessment for any variation in actual and estimated expenses of the center and for changes in
303	303	280hospital, ambulatory surgical center and non-hospital provider organization gross patient service
304	304	281revenue. Such estimated and actual expenses shall include an amount equal to the cost of fringe
305	305	282benefits and indirect expenses, as established by the comptroller under section 5D of chapter 29.
306	306	283In the event of late payment by any such hospital, ambulatory surgical center or non-hospital
307	307	284provider organization, the treasurer shall advance the amount of due and unpaid funds to the
308	308	285center prior to the receipt of such monies in anticipation of such revenues up to the amount
309	309	286authorized in the then current budget attributable to such assessments and the center shall
310	310	287reimburse the treasurer for such advances upon receipt of such revenues. This section shall not
311	311	288apply to any state institution or to any acute hospital which is operated by a city or town.
312	312	289 (d) The assessed amount for pharmaceutical manufacturing companies shall be not less
313	313	290than 5 per cent nor more than 10 per cent of the amount appropriated by the general court for the
314	314	291expenses of the center minus amounts collected from: (i) filing fees; (ii) fees and charges
315	315	292generated by the center’s publication or dissemination of reports and information; and (iii)
316	316	293federal matching revenues received for these expenses or received retroactively for expenses of
317	317	294predecessor agencies. Each pharmaceutical manufacturing company shall pay such assessed
318	318	295amount multiplied by the ratio of MassHealth’s net spending for the manufacturer’s prescription
319	319	296drugs based on the manufacturer labeler codes used in the MassHealth rebate program to
320	320	297MassHealth’s total pharmacy spending.
321	321	298 (e) The assessed amount for pharmacy benefit managers shall be not less than 5 per cent
322	322	299nor more than 10 per cent of the amount appropriated by the general court for the expenses of the
323	323	300center minus amounts collected from: (i) filing fees; (ii) fees and charges generated by the 15 of 58
324	324	301center’s publication or dissemination of reports and information; and (iii) federal matching
325	325	302revenues received for these expenses or received retroactively for expenses of predecessor
326	326	303agencies. Each pharmacy benefit manager shall pay such assessed amount multiplied by the ratio
327	327	304of the aggregate revenues of the pharmacy benefit manager attributed to residents of the
328	328	305commonwealth for whom it manages pharmaceutical benefits on behalf of carriers to the total of
329	329	306all such revenues generated by all pharmacy benefit managers attributed to residents of the
330	330	307commonwealth for whom they manage pharmaceutical benefits on behalf of carriers.
331	331	308 SECTION 23. Said chapter 12C is hereby further amended by inserting after section 10
332	332	309the following 2 sections:-
333	333	310 Section 10A. The center shall promulgate regulations necessary to ensure the uniform
334	334	311reporting of information from pharmacy benefit managers that enables the center to analyze: (i)
335	335	312year-over-year changes in wholesale acquisition cost; (ii) year-over-year trends in formulary,
336	336	313maximum allowable cost lists and cost-sharing design, including the establishment and
337	337	314management of specialty product lists; (iii) aggregate information regarding discounts,
338	338	315utilizations limits, rebates, manufacturer administrative fees and other financial incentives or
339	339	316concessions related to pharmaceutical products or formulary programs; (iv) information
340	340	317regarding the aggregate amount of payments made from a pharmacy benefit manager to
341	341	318pharmacies owned or controlled by the pharmacy benefit manager, and the aggregate amount of
342	342	319payments made from a pharmacy benefit manager to pharmacies that are not owned or controlled
343	343	320by the pharmacy benefit manager; (v) data necessary for monitoring and enforcement of chapter
344	344	321176Y and regulations promulgated thereof; and (vi) any other additional information deemed
345	345	322reasonably necessary by the center as set forth in the center’s regulations. 16 of 58
346	346	323 Section 10B. (a) As used in this section, the following words shall, unless the context
347	347	324clearly requires otherwise, have the following meanings:
348	348	325 “Cost to the commonwealth”, the cost incurred for outpatient prescription drugs by the
349	349	326office of Medicaid and the group insurance commission.
350	350	327 “Substantial net increase”, an increase in the wholesale acquisition cost less rebates paid
351	351	328to the state and payers in the commonwealth, of not less than 25 per cent in the immediate prior
352	352	329calendar year.
353	353	330 (b)(1) Annually, not later than March 31, the center shall prepare a list of not more than
354	354	33110 outpatient prescription drugs that the center determines: (i) are provided at a substantial cost
355	355	332to the commonwealth considering the net cost of such drugs; and (ii) experienced a substantial
356	356	333net increase. The list shall include outpatient prescription drugs from different therapeutic classes
357	357	334and not more than 3 generic outpatient prescription drugs.
358	358	335 (2) Prior to publishing the annual list pursuant to paragraph (1), the center shall prepare a
359	359	336preliminary list that includes outpatient prescription drugs that the center plans to include on
360	360	337such annual list. The center shall make such preliminary list available for public comment for not
361	361	338less than 30 days. During the public comment period, any manufacturer of an outpatient
362	362	339prescription drug included on the preliminary list may produce documentation, as permitted by
363	363	340federal law, to the center to establish that such drug did not experience a substantial net increase.
364	364	341If such documentation establishes, to the satisfaction of the center, that a substantial net increase
365	365	342did not occur, the center shall, not later than 15 days after the closing of the public comment
366	366	343period, remove such drug from the preliminary list before publishing the annual list pursuant to
367	367	344paragraph (1). 17 of 58
368	368	345 (c) The pharmaceutical manufacturing company that manufacturers a prescription drug
369	369	346included on the annual list prepared by the center pursuant to paragraph (1) of subsection (b)
370	370	347shall provide to the center the following:
371	371	348 (i) a written, narrative description, suitable for public release, of factors that caused the
372	372	349increase in the wholesale acquisition cost of the listed prescription drug; and
373	373	350 (ii) aggregate, company-level research and development costs and such other capital
374	374	351expenditures that the center deems relevant for the most recent calendar year for which final
375	375	352audited data is available.
376	376	353 (d) The quality and types of information and data that a pharmaceutical manufacturing
377	377	354company submits to the center pursuant to this section shall be consistent with the quality and
378	378	355types of information and data that the pharmaceutical manufacturing company includes in: (i)
379	379	356such pharmaceutical manufacturing company’s annual consolidated report on Securities and
380	380	357Exchange Commission Form 10-K; or (ii) any other public disclosure.
381	381	358 (e) The center shall consult with pharmaceutical manufacturing companies to establish a
382	382	359single, standardized form for reporting information and data pursuant to this section. The form
383	383	360shall minimize the administrative burden and cost imposed on the center and pharmaceutical
384	384	361manufacturing companies.
385	385	362 (f) The center shall compile an annual report based on the information that the center
386	386	363receives pursuant to subsection (c). The center shall publish such report and the information
387	387	364described in this section on the center’s website not later than October 1 of each year. 18 of 58
388	388	365 (g) Except as otherwise provided in this section, information and data submitted to the
389	389	366center pursuant to this section shall not be a public record and shall be exempt from disclosure
390	390	367pursuant to clause Twenty-sixth of section 7 of chapter 4 or section 10 of chapter 66. No such
391	391	368information and data shall be disclosed in a manner that may: (i) compromise the financial,
392	392	369competitive or proprietary nature of such information and data; or (ii) enable a third-party to
393	393	370identify: (A) an individual drug, therapeutic class of drugs or pharmaceutical manufacturing
394	394	371company; (B) the prices charged for any particular drug or therapeutic class of drugs; or (C) the
395	395	372value of any rebate provided for any particular drug or class of drugs.
396	396	373 SECTION 24. Said chapter 12C is hereby further amended by striking out section 11, as
397	397	374appearing in the 2022 Official Edition, and inserting in place thereof the following section:-
398	398	375 Section 11. The center shall ensure the timely reporting of information required under
399	399	376sections 8 to 10B, inclusive. The center shall notify payers, providers, provider organizations,
400	400	377pharmacy benefit managers and pharmaceutical manufacturing companies of any applicable
401	401	378reporting deadlines. The center shall notify, in writing, a payer, provider, provider organization,
402	402	379pharmacy benefit manager or pharmaceutical manufacturing company that has failed to meet a
403	403	380reporting deadline of such failure and that failure to respond within 2 weeks of the receipt of the
404	404	381notice may result in penalties. The center may assess a penalty against a payer, provider,
405	405	382provider organization, pharmacy benefit manager or pharmaceutical manufacturing company that
406	406	383fails, without just cause, to provide the requested information not later than 2 weeks following
407	407	384receipt of the written notice required under this section, of not more than $25,000 per week for
408	408	385each week of delay after the 2-week period following receipt of the notice. Amounts collected
409	409	386under this section shall be deposited in the Healthcare Payment Reform Fund established in
410	410	387section 100 of chapter 194 of the acts of 2011. 19 of 58
411	411	388 SECTION 25. Section 12 of said chapter 12C, as so appearing, is hereby amended by
412	412	389striking out, in line 2, the words “8, 9 and 10” and inserting in place thereof the following
413	413	390words:- 8 to 10B, inclusive.
414	414	391 SECTION 26. Subsection (a) of section 16 of said chapter 12C, as so appearing, is hereby
415	415	392amended by striking out the first sentence and inserting in place thereof the following sentence:-
416	416	393The center shall publish an annual report based on the information submitted pursuant to: (i)
417	417	394sections 8 to 10B, inclusive, concerning health care provider, provider organization, pharmacy
418	418	395benefit manager, pharmaceutical manufacturing company and private and public health care
419	419	396payer costs and cost and price trends; (ii) section 13 of chapter 6D relative to market impact
420	420	397reviews; and (iii) section 15 relative to quality data.
421	421	398 SECTION 27. Chapter 32A of the General Laws is hereby amended by inserting after
422	422	399section 17S the following section:-
423	423	400 Section 17T. (a) As used in this section, the following words shall, unless the context
424	424	401clearly requires otherwise, have the following meanings:
425	425	402 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
426	426	403drug application approved under 21 U.S.C. 355(c) except for: (A) any drug approved through an
427	427	404application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
428	428	405is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
429	429	406Administration, to a drug approved under 21 U.S.C. 355(c); (B) an abbreviated new drug
430	430	407application that was approved by the United States Secretary of Health and Human Services
431	431	408under section 505(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
432	432	409date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 20 of 58
433	433	4101984, Public Law 98-417, 98 Stat. 1585; or (C) an authorized generic drug as defined in 42
434	434	411C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
435	435	412under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
436	436	413based on available data resources such as Medi-Span.
437	437	414 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
438	438	415abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
439	439	416drug as defined in 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
440	440	417and was not originally marketed under a new drug application; or (iv) identified by the health
441	441	418benefit plan as a generic drug based on available data resources such as Medi-Span.
442	442	419 (b) The commission shall identify 1 generic drug and 1 brand name drug used to treat
443	443	420each of the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the most prevalent
444	444	421heart condition among its members.
445	445	422 (c) The commission shall identify insulin as the drug used to treat diabetes. In
446	446	423determining the 1 generic drug and 1 brand name drug used to treat each chronic condition, the
447	447	424commission shall consider whether the drug is:
448	448	425 (i) of clear benefit and strongly supported by clinical evidence;
449	449	426 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
450	450	427exacerbations of illness progression or improve quality of life;
451	451	428 (iii) cost effective for the commission and its members;
452	452	429 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and
453	453	430 (v) one of the most widely utilized as a treatment for the chronic condition. 21 of 58
454	454	431 (d) The commission shall provide coverage for the brand name drugs and generic drugs
455	455	432identified pursuant to subsection (b). Coverage for the identified generic drugs shall not be
456	456	433subject to any cost-sharing, including co-payments and co-insurance, and shall not be subject to
457	457	434any deductible. Coverage for identified brand name drugs shall not be subject to any deductible
458	458	435or co-insurance and any co-payment shall not exceed $25 per 30-day supply. Coverage for 1
459	459	436brand name insulin drug per dosage and type, including rapid-acting, short-acting, intermediate-
460	460	437acting, long-acting, ultra long-acting and premixed under this section shall not be subject to any
461	461	438deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply.
462	462	439 (e) The commission shall implement a continuity of coverage policy to apply to members
463	463	440that are new to the commission and that provides coverage for a 30-day fill of a United States
464	464	441Food and Drug Administration-approved drug reimbursed through a pharmacy benefit that the
465	465	442member has already been prescribed and on which the member is stable, upon documentation by
466	466	443the member’s prescriber; provided, that the commission shall not apply any greater deductible,
467	467	444coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
468	468	445covered by the plan.
469	469	446 (f) The commission shall make changes in the drugs selected pursuant to this section not
470	470	447more than annually.
471	471	448 (g) The commission shall make public the drugs selected pursuant to subsection (b).
472	472	449 SECTION 28. Chapter 94C of the General Laws is hereby amended by inserting after
473	473	450section 21B the following section:-
474	474	451 Section 21C. (a) For the purposes of this section, the following words shall, unless the
475	475	452context clearly requires otherwise, have the following meanings: 22 of 58
476	476	453 “Cost-sharing”, as defined in section 1 of chapter 176Y.
477	477	454 “Health benefit plan”, as defined in section 1 of chapter 176O.
478	478	455 “Pharmacy retail price”, the amount an individual would pay for a prescription drug at a
479	479	456pharmacy if the individual purchased that prescription drug at that pharmacy without using a
480	480	457health benefit plan or any other prescription medication benefit or discount.
481	481	458 (b) At the point of sale, a pharmacy shall charge an individual for a prescription drug the
482	482	459lesser of: (i) the applicable cost-sharing amount; or (ii) the pharmacy retail price.
483	483	460 (c) A health benefit plan or carrier shall not require an insured to make a cost-sharing
484	484	461payment for a prescription drug in an amount greater than that charged pursuant to subsection
485	485	462(b).
486	486	463 (d) No contractual obligation as between a pharmacy benefit manager and a pharmacist
487	487	464shall prohibit a pharmacist from complying with this section.
488	488	465 SECTION 29. Chapter 118E of the General Laws is hereby amended by inserting after
489	489	466section 10Q the following section:-
490	490	467 Section 10R. (a) As used in this section, the following words shall, unless the context
491	491	468clearly requires otherwise, have the following meanings:
492	492	469 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
493	493	470drug application approved under 21 U.S.C. 355(c) except for: (A) any drug approved through an
494	494	471application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
495	495	472is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
496	496	473Administration, to a drug approved under 21 U.S.C. 355(c); (B) an abbreviated new drug 23 of 58
497	497	474application that was approved by the United States Secretary of Health and Human Services
498	498	475under section 505(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
499	499	476date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
500	500	4771984, Public Law 98-417, 98 Stat. 1585; or (C) an authorized generic drug as defined in 42
501	501	478C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
502	502	479under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
503	503	480based on available data resources such as Medi-Span.
504	504	481 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
505	505	482abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
506	506	483drug as defined in 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
507	507	484and was not originally marketed under a new drug application; or (iv) identified by the health
508	508	485benefit plan as a generic drug based on available data resources such as Medi-Span.
509	509	486 (b) The division shall identify 1 generic drug and 1 brand name drug used to treat each of
510	510	487the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the most prevalent heart
511	511	488condition among its enrollees.
512	512	489 (c) The division shall identify insulin as the drug used to treat diabetes. In determining
513	513	490the 1 generic drug and 1 brand name drug used to treat each chronic condition, the division shall
514	514	491consider whether the drug is:
515	515	492 (i) of clear benefit and strongly supported by clinical evidence;
516	516	493 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
517	517	494exacerbations of illness progression or improve quality of life; 24 of 58
518	518	495 (iii) cost effective for the division and its enrollees;
519	519	496 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and
520	520	497 (v) one of the most widely utilized as a treatment for the chronic condition.
521	521	498 (d) The division and its contracted health insurers, health plans, health maintenance
522	522	499organizations, behavioral health management firms and third-party administrators under contract
523	523	500to a Medicaid managed care organization or primary care clinician plan shall provide coverage
524	524	501for the brand name drugs and generic drugs identified pursuant to subsection (b). Coverage for
525	525	502the identified generic drugs shall not be subject to any cost-sharing, including co-payments and
526	526	503co-insurance and shall not be subject to any deductible. Coverage for identified brand name
527	527	504drugs shall not be subject to any deductible or co-insurance and any co-payment shall not exceed
528	528	505$25 per 30-day supply. Coverage for 1 brand name insulin drug per dosage and type, including
529	529	506rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting and premixed under
530	530	507this section shall not be subject to any deductible or co-insurance and any co-payment shall not
531	531	508exceed $25 per 30-day supply.
532	532	509 (e) This provision shall not apply to health plans providing coverage in the senior care
533	533	510options program to MassHealth-only members who are ages 65 and older.
534	534	511 (f) The division shall implement a continuity of coverage policy that apply to enrollees
535	535	512that are new to the Medicaid program and that provides coverage for a 30-day fill of a United
536	536	513States Food and Drug Administration-approved drug reimbursed through a pharmacy benefit that
537	537	514the enrollee has already been prescribed and on which the enrollee is stable, upon documentation
538	538	515by the enrollee’s prescriber; provided, that the division shall not apply any greater deductible, 25 of 58
539	539	516coinsurance, copayments or out-of-pocket limits than would otherwise apply to other drugs
540	540	517covered by the plan.
541	541	518 (g) The division shall make changes in the drugs selected pursuant to this section not
542	542	519more than annually.
543	543	520 (h) The division shall make public the drugs selected pursuant to this subsection (b).
544	544	521 SECTION 30. Chapter 175 of the General Laws is hereby amended by inserting after
545	545	522section 47UU, added by section 56 of chapter 28 of the acts of 2023, the following section:-
546	546	523 Section 47VV. (a) As used in this section, the following words shall, unless the context
547	547	524clearly requires otherwise, have the following meanings:
548	548	525 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
549	549	526drug application approved under 21 U.S.C. 355(c) except for: (A) any drug approved through an
550	550	527application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
551	551	528is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
552	552	529Administration, to a drug approved under 21 U.S.C. 355(c); (B) an abbreviated new drug
553	553	530application that was approved by the United States Secretary of Health and Human Services
554	554	531under section 505(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
555	555	532date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
556	556	5331984, Public Law 98-417, 98 Stat. 1585; or (C) an authorized generic drug as defined in 42
557	557	534C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
558	558	535under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
559	559	536based on available data resources such as Medi-Span. 26 of 58
560	560	537 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
561	561	538abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
562	562	539drug as defined in 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
563	563	540and was not originally marketed under a new drug application; or (iv) identified by the health
564	564	541benefit plan as a generic drug based on available data resources such as Medi-Span.
565	565	542 (b) Any policy, contract, agreement, plan or certificate of insurance issued, delivered or
566	566	543renewed within the commonwealth, which is considered credible coverage under section 1 of
567	567	544chapter 111M, shall identify 1 generic drug and 1 brand name drug used to treat each of the
568	568	545following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the most prevalent heart
569	569	546condition among its enrollees.
570	570	547 (c) The carrier shall identify insulin as the drug used to treat diabetes. In determining the
571	571	5481 generic drug and 1 brand name drug used to treat each chronic condition, the carrier shall
572	572	549consider whether the drug is:
573	573	550 (i) of clear benefit and strongly supported by clinical evidence;
574	574	551 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
575	575	552exacerbations of illness progression or improve quality of life;
576	576	553 (iii) cost effective for the carrier and its enrollees;
577	577	554 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and
578	578	555 (v) one of the most widely utilized as a treatment for the chronic condition.
579	579	556 (d) Any such policy, contract, agreement, plan or certificate of insurance issued,
580	580	557delivered or renewed within the commonwealth, which is considered credible coverage under 27 of 58
581	581	558section 1 of chapter 111M, shall provide coverage for the brand name drugs and generic drugs
582	582	559identified pursuant to paragraph (b). Coverage for the identified generic drugs shall not be
583	583	560subject to any cost-sharing, including co-payments and co-insurance and shall not be subject to
584	584	561any deductible. Coverage for identified brand name drugs shall not be subject to any deductible
585	585	562or co-insurance and any co-payment shall not exceed $25 per 30-day supply. Coverage for 1
586	586	563brand name insulin drug per dosage and type, including rapid-acting, short-acting, intermediate-
587	587	564acting, long-acting, ultra long-acting and premixed under this section shall not be subject to any
588	588	565deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply.
589	589	566 (e) The carrier shall implement a continuity of coverage policy to apply to enrollees that
590	590	567are new to the carrier and that provides coverage for a 30-day fill of a United States Food and
591	591	568Drug Administration-approved drug reimbursed through a pharmacy benefit that the enrollee has
592	592	569already been prescribed and on which the enrollee is stable, upon documentation by the
593	593	570enrollee’s prescriber; provided, that a carrier shall not apply any greater deductible, coinsurance,
594	594	571copayments or out-of-pocket limits than would otherwise apply to other drugs covered by the
595	595	572plan.
596	596	573 (f) The carrier shall make changes in the drugs selected pursuant to this section not more
597	597	574than annually.
598	598	575 (g) The carrier shall make public the drugs selected pursuant to subsection (b).
599	599	576 SECTION 31. Section 226 of said chapter 175 is hereby repealed.
600	600	577 SECTION 32. Chapter 176A of the General Laws is hereby amended by inserting after
601	601	578section 8VV, added by section 58 of chapter 28 of the acts of 2023, the following section:- 28 of 58
602	602	579 Section 8WW. (a) As used in this section, the following words shall, unless the context
603	603	580clearly requires otherwise, have the following meanings:
604	604	581 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
605	605	582drug application approved under 21 U.S.C. 355(c) except for: (A) any drug approved through an
606	606	583application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
607	607	584is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
608	608	585Administration, to a drug approved under 21 U.S.C. 355(c); (B) an abbreviated new drug
609	609	586application that was approved by the United States Secretary of Health and Human Services
610	610	587under section 505(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
611	611	588date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
612	612	5891984, Public Law 98-417, 98 Stat. 1585; or (C) an authorized generic drug as defined in 42
613	613	590C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
614	614	591under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
615	615	592based on available data resources such as Medi-Span.
616	616	593 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
617	617	594abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
618	618	595drug as defined in 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
619	619	596and was not originally marketed under a new drug application; or (iv) identified by the health
620	620	597benefit plan as a generic drug based on available data resources such as Medi-Span.
621	621	598 (b) Any contract between a subscriber and the corporation under an individual or group
622	622	599hospital service plan that is delivered, issued or renewed within the commonwealth shall identify 29 of 58
623	623	6001 generic drug and 1 brand name drug used to treat each of the following chronic conditions: (i)
624	624	601diabetes; (ii) asthma; and (iii) the most prevalent heart condition among its enrollees.
625	625	602 (c) The carrier shall identify insulin as the drug used to treat diabetes. In determining the
626	626	6031 generic drug and 1 brand name drug used to treat each chronic condition, the carrier shall
627	627	604consider whether the drug is:
628	628	605 (i) of clear benefit and strongly supported by clinical evidence;
629	629	606 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
630	630	607exacerbations of illness progression or improve quality of life;
631	631	608 (iii) cost effective for the carrier and its enrollees;
632	632	609 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and
633	633	610 (v) one of the most widely utilized as a treatment for the chronic condition.
634	634	611 (d) Any contract between a subscriber and the corporation under an individual or group
635	635	612hospital service plan that is delivered, issued or renewed within the commonwealth shall provide
636	636	613coverage for the brand name drugs and generic drugs identified pursuant to subsection (b).
637	637	614Coverage for the identified generic drugs shall not be subject to any cost-sharing, including co-
638	638	615payments and co-insurance and shall not be subject to any deductible. Coverage for identified
639	639	616brand name drugs shall not be subject to any deductible or co-insurance and any co-payment
640	640	617shall not exceed $25 per 30-day supply. Coverage for 1 brand name insulin drug per dosage and
641	641	618type, including rapid-acting, short-acting, intermediate-acting, long-acting, ultra long-acting and
642	642	619premixed under this section shall not be subject to any deductible or co-insurance and any co-
643	643	620payment shall not exceed $25 per 30-day supply. 30 of 58
644	644	621 (e) The carrier shall implement a continuity of coverage policy to apply to enrollees that
645	645	622are new to the plan and that provides coverage for a 30-day fill of a United States Food and Drug
646	646	623Administration-approved drug reimbursed through a pharmacy benefit that the enrollee has
647	647	624already been prescribed and on which the enrollee is stable, upon documentation by the
648	648	625enrollee’s prescriber; provided, that a carrier shall not apply any greater deductible, coinsurance,
649	649	626copayments or out-of-pocket limits than would otherwise apply to other drugs covered by the
650	650	627plan.
651	651	628 (f) The carrier shall make changes in the drugs selected pursuant to this section not more
652	652	629than annually.
653	653	630 (g) The carrier shall make public the drugs selected pursuant to subsection (b).
654	654	631 SECTION 33. Chapter 176B of the General Laws is hereby amended by inserting after
655	655	632section 4VV, added by section 59 of chapter 28 of the acts of 2023, the following section:-
656	656	633 Section 4WW. (a) As used in this section, the following words shall, unless the context
657	657	634clearly requires otherwise, have the following meanings:
658	658	635 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
659	659	636drug application approved under 21 U.S.C. 355(c) except for: (A) any drug approved through an
660	660	637application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
661	661	638is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
662	662	639Administration, to a drug approved under 21 U.S.C. 355(c); (B) an abbreviated new drug
663	663	640application that was approved by the United States Secretary of Health and Human Services
664	664	641under section 505(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
665	665	642date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of 31 of 58
666	666	6431984, Public Law 98-417, 98 Stat. 1585; or (C) an authorized generic drug as defined in 42
667	667	644C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
668	668	645under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
669	669	646based on available data resources such as Medi-Span.
670	670	647 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
671	671	648abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
672	672	649drug as defined in 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
673	673	650and was not originally marketed under a new drug application; or (iv) identified by the health
674	674	651benefit plan as a generic drug based on available data resources such as Medi-Span.
675	675	652 (b) A subscription certificate under an individual or group medical service agreement
676	676	653delivered, issued or renewed within the commonwealth shall identify 1 generic drug and 1 brand
677	677	654name drug used to treat each of the following chronic conditions: (i) diabetes; (ii) asthma; and
678	678	655(iii) the most prevalent heart condition among its enrollees.
679	679	656 (c) The carrier shall identify insulin as the drug used to treat diabetes. In determining the
680	680	6571 generic drug and 1 brand name drug used to treat each chronic condition, the carrier shall
681	681	658consider whether the drug is:
682	682	659 (i) of clear benefit and strongly supported by clinical evidence;
683	683	660 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
684	684	661exacerbations of illness progression or improve quality of life;
685	685	662 (iii) cost effective for the carrier and its enrollees;
686	686	663 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and 32 of 58
687	687	664 (v) one of the most widely utilized as a treatment for the chronic condition.
688	688	665 (d) A subscription certificate under an individual or group medical service agreement
689	689	666delivered, issued or renewed within the commonwealth shall provide coverage for the brand
690	690	667name drugs and generic drugs identified pursuant to subsection (b). Coverage for the identified
691	691	668generic drugs shall not be subject to any cost-sharing, including co-payments and co-insurance
692	692	669and shall not be subject to any deductible. Coverage for identified brand name drugs shall not be
693	693	670subject to any deductible or co-insurance and any co-payment shall not exceed $25 per 30-day
694	694	671supply. Coverage for 1 brand name insulin drug per dosage and type, including rapid-acting,
695	695	672short-acting, intermediate-acting, long-acting, ultra long-acting and premixed under this section
696	696	673shall not be subject to any deductible or co-insurance and any co-payment shall not exceed $25
697	697	674per 30-day supply.
698	698	675 (e) The carrier shall implement a continuity of coverage policy to apply to enrollees that
699	699	676are new to the plan and that provides coverage for a 30-day fill of a United States Food and Drug
700	700	677Administration-approved drug reimbursed through a pharmacy benefit that the enrollee has
701	701	678already been prescribed and on which the enrollee is stable, upon documentation by the
702	702	679enrollee’s prescriber; provided, that a carrier shall not apply any greater deductible, coinsurance,
703	703	680copayments or out-of-pocket limits than would otherwise apply to other drugs covered by the
704	704	681plan.
705	705	682 (f) The carrier shall make changes in the drugs selected pursuant to this section not more
706	706	683than annually.
707	707	684 (g) The carrier shall make public the drugs selected pursuant to subsection (b). 33 of 58
708	708	685 SECTION 34. Chapter 176G of the General Laws is hereby amended by inserting after
709	709	686section 4NN, added by section 60 of chapter 28 of the acts of 2023, the following section:-
710	710	687 Section 4OO. (a) As used in this section, the following words shall, unless the context
711	711	688clearly requires otherwise, have the following meanings:
712	712	689 “Brand name drug”, a drug that is: (i) produced or distributed pursuant to an original new
713	713	690drug application approved under 21 U.S.C. 355(c) except for: (A) any drug approved through an
714	714	691application submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act that
715	715	692is pharmaceutically equivalent, as that term is defined by the United States Food and Drug
716	716	693Administration, to a drug approved under 21 U.S.C. 355(c); (B) an abbreviated new drug
717	717	694application that was approved by the United States Secretary of Health and Human Services
718	718	695under section 505(c) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 355(c), before the
719	719	696date of the enactment of the federal Drug Price Competition and Patent Term Restoration Act of
720	720	6971984, Public Law 98-417, 98 Stat. 1585; or (C) an authorized generic drug as defined in 42
721	721	698C.F.R. 447.502; (ii) produced or distributed pursuant to a biologics license application approved
722	722	699under 42 U.S.C. 262(a)(2)(C); or (iii) identified by the health benefit plan as a brand name drug
723	723	700based on available data resources such as Medi-Span.
724	724	701 “Generic drug”, a retail drug that is: (i) marketed or distributed pursuant to an
725	725	702abbreviated new drug application approved under 21 U.S.C. 355(j); (ii) an authorized generic
726	726	703drug as defined in 42 C.F.R. 447.502; (iii) a drug that entered the market before January 1, 1962
727	727	704and was not originally marketed under a new drug application; or (iv) identified by the health
728	728	705benefit plan as a generic drug based on available data resources such as Medi-Span. 34 of 58
729	729	706 (b) An individual group health maintenance contract that is issued or renewed within or
730	730	707without the commonwealth shall identify 1 generic drug and 1 brand name drug used to treat
731	731	708each of the following chronic conditions: (i) diabetes; (ii) asthma; and (iii) the most prevalent
732	732	709heart condition among its enrollees.
733	733	710 (c) The carrier shall identify insulin as the drug used to treat diabetes. In determining the
734	734	7111 generic drug and 1 brand name drug used to treat each chronic condition, the carrier shall
735	735	712consider whether the drug is:
736	736	713 (i) of clear benefit and strongly supported by clinical evidence to be cost-effective;
737	737	714 (ii) likely to reduce hospitalizations or emergency department visits, reduce future
738	738	715exacerbations of illness progression or improve quality of life;
739	739	716 (iii) cost effective for the carrier and its enrollees;
740	740	717 (iv) at low risk for overutilization, abuse, addiction, diversion or fraud; and
741	741	718 (v) one of the most widely utilized as a treatment for the chronic condition.
742	742	719 (d) An individual group health maintenance contract that is issued or renewed within or
743	743	720without the commonwealth shall provide coverage for the brand name drugs and generic drugs
744	744	721identified pursuant to subsection (b). Coverage for the identified generic drugs shall not be
745	745	722subject to any cost-sharing, including co-payments and co-insurance and shall not be subject to
746	746	723any deductible. Coverage for identified brand name drugs shall not be subject to any deductible
747	747	724or co-insurance and any co-payment shall not exceed $25 per 30-day supply. Coverage for 1
748	748	725brand name insulin drug per dosage and type, including rapid-acting, short-acting, intermediate- 35 of 58
749	749	726acting, long-acting, ultra long-acting and premixed under this section shall not be subject to any
750	750	727deductible or co-insurance and any co-payment shall not exceed $25 per 30-day supply.
751	751	728 (e) The carrier shall implement a continuity of coverage policy to apply to enrollees that
752	752	729are new to the plan and that provides coverage for a 30-day fill of a United States Food and Drug
753	753	730Administration-approved drug reimbursed through a pharmacy benefit that the enrollee has
754	754	731already been prescribed and on which the enrollee is stable, upon documentation by the
755	755	732enrollee’s prescriber; provided, that a carrier shall not apply any greater deductible, coinsurance,
756	756	733copayments or out-of-pocket limits than would otherwise apply to other drugs covered by the
757	757	734plan.
758	758	735 (f) The carrier shall make changes in the drugs selected pursuant to this section not more
759	759	736than annually.
760	760	737 (g) The carrier shall make public the drugs selected pursuant to subsection (b).
761	761	738 SECTION 35. Chapter 176O of the General Laws is hereby amended by adding the
762	762	739following 2 sections:-
763	763	740 Section 30. (a) On an annual basis, each carrier shall report to the division the drugs
764	764	741selected to be provided with no or limited cost-sharing under section 47VV of chapter 175,
765	765	742section 8WW of chapter 176A, section 4WW of chapter 176B and section 4OO of chapter 176G.
766	766	743The commissioner shall review the drugs to verify that the selected drugs meet the criteria
767	767	744identified in those sections. Should a selected drug be deemed by the commissioner to not meet
768	768	745the criteria, the commissioner may require a different drug to be selected. The commissioner
769	769	746shall disclose the list of drugs selected by each entity annually on the division’s website. 36 of 58
770	770	747 Section 31. (a) As used in this section, the following words shall, unless the context
771	771	748clearly requires otherwise, have the following meanings:
772	772	749 “Cost-sharing”, as defined in section 1 of chapter 176Y.
773	773	750 “Estimated rebate”, any: (i) negotiated price concessions, whether described as a rebate
774	774	751or otherwise, including, but not limited to, base price concessions, and reasonable estimates of
775	775	752any price protection rebates and performance-based price concessions that may accrue, directly
776	776	753or indirectly, to a carrier, pharmacy benefit manager or other party on a carrier’s behalf during a
777	777	754carrier’s plan year from a pharmaceutical manufacturing company, dispensing pharmacy or other
778	778	755party to the transaction based on the amounts the carrier received in the prior quarter or
779	779	756reasonably expects to receive in the current quarter; and (ii) reasonable estimates of any price
780	780	757concessions, fees and other administrative costs that are passed through, or are reasonably
781	781	758anticipated to be passed through to the carrier, pharmacy benefit manager or other party on the
782	782	759carrier’s behalf and that serve to reduce the carrier’s prescription drug liabilities for the plan year
783	783	760based on the amounts the carrier received in the prior quarter or reasonably expects to receive in
784	784	761the current quarter.
785	785	762 “Pharmacy benefit manager”, as defined in section 1 of chapter 176Y.
786	786	763 “Price protection rebate”, a negotiated price concession that accrues directly or indirectly
787	787	764to the carrier, or other party on behalf of the carrier, including a pharmacy benefit manager, in
788	788	765the event of an increase in the wholesale acquisition cost of a drug that is greater than a specified
789	789	766threshold.
790	790	767 (b) A carrier, or any pharmacy benefit manager, shall make available to an insured at
791	791	768least 80 per cent of the estimated rebates received by such carrier, or any pharmacy benefit 37 of 58
792	792	769manager, by reducing the amount of defined cost-sharing that the carrier would otherwise charge
793	793	770at the point of sale, except that the reduction amount shall not result in a credit at the point of
794	794	771sale. Neither the insured nor the carrier shall be responsible for any difference between the
795	795	772estimated rebate amount and the actual rebate amount the carrier receives; provided, that such
796	796	773estimates were calculated in good faith.
797	797	774 (c) Nothing in this section shall preclude a pharmacy benefit manager from decreasing an
798	798	775insured’s defined cost-sharing by an amount greater than that required under subsection (b).
799	799	776 (d) Annually, not later than April 1, a carrier shall file with the division a report in the
800	800	777manner and form determined by the commissioner demonstrating the manner in which the carrier
801	801	778has complied with this section. If the commissioner determines that a carrier has not complied
802	802	779with 1 or more requirements of this section, the commissioner shall notify the carrier of such
803	803	780noncompliance and a date by which the carrier must demonstrate compliance. If the carrier does
804	804	781not come into compliance by such date, the division shall impose a fine not to exceed $5,000 for
805	805	782each day during which such noncompliance continues.
806	806	783 (e) In implementing the requirements of this section, the division shall only regulate a
807	807	784carrier or pharmacy benefit manager to the extent permissible under applicable law.
808	808	785 (f) A pharmacy benefit manager, its agent or any third-party administrator shall not
809	809	786publish or otherwise disclose information regarding the actual amount of rebates a carrier
810	810	787receives on a specific product or therapeutic class of products, manufacturer or pharmacy-
811	811	788specific basis. Such information shall be considered to be a trade secret and confidential
812	812	789commercial information, shall not be a public record as defined by clause Twenty-sixth of
813	813	790section 7 of chapter 4 or section 10 of chapter 66, and shall not be disclosed directly or 38 of 58
814	814	791indirectly, or in a manner that would allow for the identification of an individual product,
815	815	792therapeutic class of products or manufacturer, or in a manner that would have the potential to
816	816	793compromise the financial, competitive or proprietary nature of the information. A pharmacy
817	817	794benefit manager shall impose the confidentiality protections and requirements of this section on
818	818	795any agent or third-party administrator that performs health care or administrative services on
819	819	796behalf of the pharmacy benefit manager that may receive or have access to rebate related
820	820	797information.
821	821	798 SECTION 36. The General Laws are hereby amended by inserting after chapter 176X
822	822	799 the following chapter:-
823	823	800 CHAPTER 176Y
824	824	801 LICENSURE AND REGULATION OF PHARMACY BENEFIT MANAGERS
825	825	802 Section 1. As used in this chapter, unless the context clearly requires otherwise, the
826	826	803following words shall have the following meanings:
827	827	804 “Carrier”, as defined in section 1 of chapter 176O.
828	828	805 “Clean claim”, a claim that has no defect or impropriety, including a lack of any required
829	829	806substantiating documentation, or other circumstance requiring special treatment that prevents
830	830	807timely payment from being made on the claim.
831	831	808 “Commissioner”, the commissioner of the division of insurance. 39 of 58
832	832	809 “Cost-sharing”, any copayment, coinsurance, deductible or any other amount owed by an
833	833	810insured under the terms of the insured’s health benefit plan, or as required by a pharmacy benefit
834	834	811manager.
835	835	812 “Division”, the division of insurance.
836	836	813 “Health benefit plan”, as defined in section 1 of chapter 176O.
837	837	814 “Independent pharmacy”, a pharmacy registered under section 39 of chapter 112 that is
838	838	815under common ownership with not more than 5 other pharmacies.
839	839	816 “Insured”, as defined in section 1 of chapter 176O.
840	840	817 “Mail-order pharmacy”, a pharmacy whose primary business is to receive prescriptions
841	841	818by mail, telefax or through electronic submissions and to dispense medication to insureds
842	842	819through the use of the United States mail or other common or contract carrier services.
843	843	820 “Net price”, a price for a prescription drug that takes into account all rebates received or
844	844	821expected to be received in connection with the dispensing or administration of the prescription
845	845	822drug.
846	846	823 “Pharmacy”, a facility under the direction or supervision of a registered pharmacist
847	847	824authorized to dispense controlled substances under the supervision of a pharmacist registered in
848	848	825the commonwealth under section 39 of chapter 112.
849	849	826 “Pharmacy benefit management services”, services performed by a pharmacy benefit
850	850	827manager, including: (i) negotiating the price of prescription drugs, including negotiating and
851	851	828contracting for direct or indirect rebates, discounts or other price concessions; (ii) managing any
852	852	829aspects of a prescription drug benefit, including, but not limited to, formulary administration, 40 of 58
853	853	830mail and specialty drug pharmacy services, clinical, safety and adherence programs for pharmacy
854	854	831service, the processing and payment of claims for prescription drugs, arranging alternative access
855	855	832to or funding for prescription drugs, the performance of drug utilization review, the processing of
856	856	833drug prior authorization requests, the adjudication of appeals or grievances related to the
857	857	834prescription drug benefit, contracting with network pharmacies, controlling the cost of covered
858	858	835prescription drugs and managing or providing data relating to the prescription drug benefit or the
859	859	836provision of services related thereto; (iii) performance of any administrative, managerial,
860	860	837clinical, pricing, financial, reimbursement, data administration or reporting or billing service
861	861	838related to a health benefit plan’s prescription drug benefit; and (iv) such other services as the
862	862	839division may define in regulation.
863	863	840 “Pharmacy benefit manager”, a person, business or other entity that, pursuant to a
864	864	841contract or under an employment relationship with a carrier, a self-insurance plan or other third-
865	865	842party administrator, either directly or through an intermediary, performs pharmacy benefit
866	866	843management services; provided, that “pharmacy benefit manager” shall include a health benefit
867	867	844plan sponsor that does not contract with a pharmacy benefit manager and manages its own
868	868	845prescription drug benefits unless specifically exempted by the division.
869	869	846 “Pharmacy benefit manager network”, a network of pharmacies or pharmacists that are
870	870	847offered an agreement or contract to provide pharmacy services for a pharmacy benefit manager
871	871	848or health benefit plan.
872	872	849 “Rebate”, any: (i) negotiated price concessions, whether described as a rebate or
873	873	850otherwise, including, but not limited to, base price concessions and reasonable estimates of any
874	874	851price protection rebates and performance-based price concessions that may accrue, directly or 41 of 58
875	875	852indirectly, to a carrier, pharmacy benefit manager or other party on a carrier’s behalf during a
876	876	853carrier’s plan year from a pharmaceutical manufacturing company, dispensing pharmacy or other
877	877	854party to the transaction based on the amounts the carrier received in the prior quarter or
878	878	855reasonably expects to receive in the current quarter; and (ii) reasonable estimates of any price
879	879	856concessions, fees and other administrative costs that are passed through, or are reasonably
880	880	857anticipated to be passed through to the carrier, pharmacy benefit manager or other party on the
881	881	858carrier’s behalf, and that serve to reduce the carrier’s prescription drug liabilities for the plan
882	882	859year based on the amounts the carrier received in the prior quarter or reasonably expects to
883	883	860receive in the current quarter.
884	884	861 “Spread pricing”, model of prescription drug pricing in which the pharmacy benefits
885	885	862manager charges a health benefit plan a contracted price for prescription drugs, and the
886	886	863contracted price for the prescription drugs differs from the amount the pharmacy benefits
887	887	864manager directly or indirectly pays the pharmacy.
888	888	865 “Third-party administrator”, any person that directly or indirectly solicits or effects
889	889	866coverage of, underwrites, collects charges or premiums from, arranges alternative access to or
890	890	867funding for prescription drugs, or adjusts or settles claims on behalf of residents of the
891	891	868commonwealth or residents of another state from offices in this commonwealth, in connection
892	892	869with health insurance coverage.
893	893	870 Section 2. (a) No person, business or other entity shall establish or operate as a pharmacy
894	894	871benefit manager without obtaining a license from the division pursuant to this section. A license
895	895	872shall be granted only when the division is satisfied that the entity possesses the necessary
896	896	873organization, background expertise and financial integrity to supply the services sought to be 42 of 58
897	897	874offered. A pharmacy benefit manager license shall be valid for a period of 3 years and shall be
898	898	875renewable for additional 3-year periods. The commissioner shall charge application and renewal
899	899	876fees in the amount of $25,000. A license granted pursuant to this section and any rights or
900	900	877interests therein shall not be transferable.
901	901	878 (b) The division shall develop an application for licensure that includes at least the
902	902	879following information: (i) the name of the applicant or pharmacy benefit manager; (ii) the
903	903	880address and contact telephone number for the applicant or pharmacy benefit manager; (iii) the
904	904	881name and address of the agent of the applicant or pharmacy benefit manager for service of
905	905	882process in the commonwealth; and (iv) the name and address of each person with management or
906	906	883control over the applicant or pharmacy benefit manager.
907	907	884 (c)(1) The division may suspend, revoke or place on probation a pharmacy benefit
908	908	885manager license if: (i) the pharmacy benefit manager has engaged in fraudulent activity that is
909	909	886found by a court of law to be a violation of state or federal law; (ii) the division receives
910	910	887consumer complaints that justify an action under this chapter to protect the safety and interests of
911	911	888consumers; (iii) the pharmacy benefit manager fails to pay an application fee for the license; (iv)
912	912	889the pharmacy benefit manager fails to comply with a requirement set forth in this chapter; or (v)
913	913	890the pharmacy benefit manager fails to comply with reporting requirements of the center for
914	914	891health information and analysis under section 10A of chapter 12C.
915	915	892 (2) The division shall provide written notice to the pharmacy benefit manager and advise
916	916	893in writing of the reason for any suspension, revocation or placement on probation of a pharmacy
917	917	894benefit manager license under this chapter. The pharmacy benefit manager may make written
918	918	895demand upon the division within 30 days of receipt of such notification for a hearing before the 43 of 58
919	919	896division to determine the reasonableness of the division’s action. The hearing shall be held
920	920	897pursuant to chapter 30A. The division shall not suspend or cancel a license unless the division
921	921	898has first afforded the pharmacy benefit manager an opportunity for a hearing pursuant to said
922	922	899chapter 30A.
923	923	900 (d) If a person, business or other entity performs the functions of a pharmacy benefit
924	924	901manager in violation of this chapter, the person, business or other entity shall be subject to a fine
925	925	902of not less than $5,000 per day for each day that the person, business or other entity is found by
926	926	903the division to be in violation.
927	927	904 (e) A pharmacy benefit manager that violates this chapter or any rule or regulation
928	928	905promulgated pursuant to this chapter shall be subject to a fine of not less than $5,000 for each
929	929	906violation.
930	930	907 Section 3. (a)(1) A pharmacy benefit manager shall have a duty to perform pharmacy
931	931	908benefit management services with care, skill, prudence, diligence and professionalism. Such duty
932	932	909shall extend to both the insured and the health plan for whom the pharmacy benefit manager is
933	933	910performing pharmacy benefit management services.
934	934	911 (2) A pharmacy benefit manager interacting with an insured shall have the same duty to
935	935	912an insured as the health plan for whom it is performing pharmacy benefit services.
936	936	913 (b) A pharmacy benefit manager shall have a duty of good faith and fair dealing with all
937	937	914parties with which it interacts in the performance of pharmacy benefit management services.
938	938	915 Section 4. (a) A pharmacy benefit manager shall provide a reasonably adequate and
939	939	916accessible pharmacy benefit manager network for the provision of prescription drugs, which 44 of 58
940	940	917shall provide for convenient patient access to pharmacies within a reasonable distance from a
941	941	918patient’s residence.
942	942	919 (b) A pharmacy benefit manager shall not deny a pharmacy the opportunity to participate
943	943	920in a pharmacy benefit manager network at preferred participation status if the pharmacy is
944	944	921willing to accept the terms and conditions that the pharmacy benefit manager has established for
945	945	922other pharmacies as a condition of preferred network participation status.
946	946	923 (c) A mail-order pharmacy shall not be included in the calculations for determining
947	947	924pharmacy benefit manager network adequacy.
948	948	925 Section 5. (a) After adjudication of a clean claim for payment made by a pharmacy, a
949	949	926pharmacy benefit manager shall not retroactively reduce payment on the claim, either directly or
950	950	927indirectly, through an aggregated effective rate, direct or indirect remuneration, quality assurance
951	951	928program or otherwise, except if the claim: (i) is found not to be a clean claim during the course
952	952	929of a routine audit performed pursuant to an agreement between the pharmacy benefit manager
953	953	930and the pharmacy; or (ii) was submitted as a result of fraud, waste, abuse or other intentional
954	954	931misconduct.
955	955	932 (b) When a pharmacy adjudicates a claim, the reimbursement amount provided to the
956	956	933pharmacy by the pharmacy benefit manager shall constitute a final reimbursement amount;
957	957	934provided, however, that nothing in this section shall be construed to prohibit any retroactive
958	958	935increase in payment to a pharmacy pursuant to a contract between the pharmacy benefit manager
959	959	936or a pharmacy.
960	960	937 (c) No pharmacy benefit manager shall charge or collect from an insured any cost-sharing
961	961	938amount that exceeds the total contracted amount by the pharmacy for which the pharmacy is 45 of 58
962	962	939paid. If an insured pays a copayment, the pharmacy shall retain the adjudicated costs and the
963	963	940pharmacy benefit manager shall not reduce or recoup the adjudicated cost.
964	964	941 Section 6. (a) As used in this section the following words shall, unless the context clearly
965	965	942requires otherwise, have the following meanings:
966	966	943 “Generically equivalent drug”, a drug that is pharmaceutically and therapeutically
967	967	944equivalent to the drug prescribed.
968	968	945 “Maximum allowable cost list”, a listing of drugs or other methodology used by a
969	969	946pharmacy benefit manager, directly or indirectly, to set the maximum allowable payment to a
970	970	947pharmacy for a generic drug.
971	971	948 “National Drug Code”, the numerical code assigned to a prescription drug by the United
972	972	949States Food and Drug Administration.
973	973	950 “Pharmacy acquisition cost”, the net amount a pharmacy paid for a pharmaceutical
974	974	951product.
975	975	952 “Pharmacy benefit manager affiliate”, a pharmacy that directly or indirectly, through 1 or
976	976	953more intermediaries, owns or controls, is owned or controlled by or is under common ownership
977	977	954or control with a pharmacy benefits manager.
978	978	955 (b) A drug shall not be placed on a maximum allowable cost list unless:
979	979	956 (i) the drug is a generically equivalent drug, it is listed as therapeutically equivalent and
980	980	957pharmaceutically equivalent A or B rated in the United States Food and Drug Administration's
981	981	958most recent version of the Orange Book or Green Book, it has an NR or NA rating by Medi-Span
982	982	959or Gold Standard, or it has a similar rating by a nationally recognized reference; 46 of 58
983	983	960 (ii) the drug is in stock and available for purchase by each pharmacy in the pharmacy
984	984	961benefit manager’s network from wholesale drug distributors licensed under section 36B of
985	985	962chapter 112; and
986	986	963 (iii) the drug is not obsolete.
987	987	964 (c) A pharmacy benefit manager shall:
988	988	965 (i) provide access to its maximum allowable cost list to each pharmacy in the pharmacy
989	989	966benefit manager’s network that is subject to the maximum allowable cost list;
990	990	967 (ii) update its maximum allowable cost list on a timely basis, but not less than once every
991	991	9687 calendar days;
992	992	969 (iii) provide a process for each pharmacy subject to the maximum allowable cost list to
993	993	970receive prompt notification of an update to the maximum allowable cost list; and
994	994	971 (iv) provide a reasonable internal grievance process consistent with subsection (d) to
995	995	972allow pharmacies to challenge a maximum allowable cost list as not compliant with this section,
996	996	973and to challenge reimbursements made under a maximum allowable cost list for a specific drug
997	997	974or drugs that are below the pharmacy acquisition cost.
998	998	975 (d)(1) A pharmacy benefit manager shall maintain a formal internal grievance process for
999	999	976pharmacies, and such formal internal grievance process shall provide for adequate consideration
1000	1000	977and timely resolution of grievances. A pharmacy benefit manager’s internal grievance process
1001	1001	978shall include the following: (i) a dedicated telephone number, email address and website for the
1002	1002	979purpose of submitting a grievance; (ii) the ability to submit a grievance directly to the pharmacy 47 of 58
1003	1003	980benefit manager regarding the pharmacy benefits plan or program; and (iii) the ability to file a
1004	1004	981grievance within not less than 30 business days of the qualifying event.
1005	1005	982 (2) The pharmacy benefit manager shall respond to a grievance within 30 business days
1006	1006	983of receipt of the grievance. If the pharmacy benefit manager determines as a result of the internal
1007	1007	984grievance process that the pharmacy benefit manager’s challenged conduct was not compliant
1008	1008	985with this section, the pharmacy benefit manager shall: (i) provide the pharmacy with the National
1009	1009	986Drug Code upon which the maximum allowable cost was based; (ii) reprocess the claim; (iii)
1010	1010	987reimburse the pharmacy in an amount that is not less than the pharmacy acquisition cost; and (iv)
1011	1011	988to the extent practicable, reprocess claims submitted by similarly situated pharmacies and
1012	1012	989reimburse said pharmacies an amount that is not less than the pharmacy acquisition cost.
1013	1013	990 (3) If the pharmacy benefit manager determines as a result of the internal grievance
1014	1014	991process that the pharmacy benefit manager’s challenged conduct was compliant with this section,
1015	1015	992the pharmacy benefit manager shall: (i) provide the pharmacy with the National Drug Code upon
1016	1016	993which the maximum allowable cost was based and the name of any wholesale drug distributors
1017	1017	994licensed under section 36B of chapter 112 that have the drug currently in stock at a price below
1018	1018	995the maximum allowable cost; or (ii) if the National Drug Code provided by the pharmacy benefit
1019	1019	996manager is not available at a price below the pharmacy acquisition cost from the wholesale drug
1020	1020	997distributor from whom the pharmacy purchases the majority of its prescription drugs for resale,
1021	1021	998then the pharmacy benefit manager shall adjust the maximum allowable cost as listed on the
1022	1022	999maximum allowable cost list above the challenging pharmacy's pharmacy acquisition cost, and
1023	1023	1000permit the pharmacy to reverse and rebill each claim affected by the inability to procure the drug
1024	1024	1001at a cost that is equal to or less than the challenged maximum allowable cost. 48 of 58
1025	1025	1002 (e) A pharmacy benefit manager shall not reimburse an independent pharmacy an amount
1026	1026	1003less than the amount that the pharmacy benefit manager reimburses a pharmacy benefit manager
1027	1027	1004affiliate for providing the same pharmacist services. The reimbursement amount shall be
1028	1028	1005calculated on a per unit basis using the same Medi-Span generic product identifier or First
1029	1029	1006DataBank generic code number.
1030	1030	1007 (f) A violation of this section shall constitute an unfair or deceptive act or practice under
1031	1031	1008chapter 93A.
1032	1032	1009 Section 7. (a) No pharmacy benefit manager or carrier may, either directly or indirectly
1033	1033	1010through an intermediary, agent or affiliate, engage in spread pricing. A pharmacy benefit
1034	1034	1011manager or carrier that violates this section shall be subject to the surcharge under section 8. A
1035	1035	1012carrier shall be jointly responsible to pay the surcharge amount for violations of this section by
1036	1036	1013its contracted pharmacy benefit manager.
1037	1037	1014 (b) A pharmacy benefit manager shall report to the commissioner on a quarterly basis, for
1038	1038	1015each health benefit plan with which it contracts, the data required to be collected by the center
1039	1039	1016for health information and analysis pursuant to section 10A of chapter 12C.
1040	1040	1017 Section 8. (a) A pharmacy benefit manager or carrier shall be subject to a surcharge
1041	1041	1018payable to the division equal to 10 per cent of the aggregate dollar amount of reimbursements
1042	1042	1019paid by the pharmacy benefit manager or carrier to pharmacies in the previous contract year for
1043	1043	1020prescription drugs in the commonwealth if the pharmacy benefit manager or carrier: (i) engages
1044	1044	1021in spread pricing; or (ii) imposes point-of-sale fees or retroactive fees. 49 of 58
1045	1045	1022 (b) A pharmacy benefit manager or carrier subject to enforcement action by the division
1046	1046	1023for a violation of this section shall, upon the filing of a written request with the division, be
1047	1047	1024afforded an adjudicatory hearing pursuant to chapter 30A.
1048	1048	1025 Section 9. (a) When calculating an insured’s contribution to any applicable cost-sharing
1049	1049	1026requirement, a carrier shall include any cost-sharing amounts paid by the insured or on behalf of
1050	1050	1027the insured by another person. If under federal law, application of this requirement would result
1051	1051	1028in health savings account ineligibility under section 223 of the federal Internal Revenue Code,
1052	1052	1029this requirement shall apply for health savings account-qualified high deductible health plans
1053	1053	1030with respect to the deductible of such a plan after the insured has satisfied the minimum
1054	1054	1031deductible under section 223 of the federal Internal Revenue Code, except for with respect to
1055	1055	1032items or services that are preventive care pursuant to section 223(c)(2)(C) of the federal Internal
1056	1056	1033Revenue Code, in which case the requirements of this paragraph shall apply regardless of
1057	1057	1034whether the minimum deductible under section 223 has been satisfied.
1058	1058	1035 (b) A carrier, pharmacy benefit manager or third-party administrator shall not directly or
1059	1059	1036indirectly set, alter, implement or condition the terms of health benefit plan coverage, including
1060	1060	1037the benefit design, based in part or entirely on information about the availability or amount of
1061	1061	1038financial or product assistance available for a prescription drug.
1062	1062	1039 (c) The division may promulgate such rules and regulations as it may deem necessary to
1063	1063	1040implement this section.
1064	1064	1041 Section 10. (a)(1) A pharmacy benefit manager shall conduct an audit of the records of a
1065	1065	1042pharmacy with which it contracts. 50 of 58
1066	1066	1043 (2) The contract between a pharmacy and a pharmacy benefit manager shall identify and
1067	1067	1044describe the audit procedures in detail.
1068	1068	1045 (3) With the exception of an investigative fraud audit, the auditor shall give the pharmacy
1069	1069	1046written notice not less than 2 weeks prior to conducting the initial on-site audit for each audit
1070	1070	1047cycle.
1071	1071	1048 (4) A pharmacy benefit manager shall not audit claims beyond 2 years prior to the date of
1072	1072	1049audit.
1073	1073	1050 (5) The auditor shall not interfere with the delivery of pharmacist services to a patient and
1074	1074	1051shall make a reasonable effort to minimize the inconvenience and disruption to the pharmacy
1075	1075	1052operations during the audit process.
1076	1076	1053 (6) Any audit that involves clinical or professional judgment shall be conducted by, or in
1077	1077	1054consultation with, a licensed pharmacist from any state.
1078	1078	1055 (7) A finding of an overpayment or underpayment shall be based on the actual
1079	1079	1056overpayment or underpayment. A statistically sound calculation for overpayment or
1080	1080	1057underpayment may be used to determine recoupment as part of a settlement as agreed to by the
1081	1081	1058pharmacy.
1082	1082	1059 (8) The auditor shall audit each pharmacy under the same standards and parameters with
1083	1083	1060which they audit other similarly situated pharmacies.
1084	1084	1061 (9) An audit shall not be initiated or scheduled during the first 5 calendar days of any
1085	1085	1062month for any pharmacy that averages more than 600 prescriptions per week without the
1086	1086	1063pharmacy’s consent. 51 of 58
1087	1087	1064 (10) A preliminary audit report shall be delivered to the pharmacy not later than 30 days
1088	1088	1065after the conclusion of the audit.
1089	1089	1066 (11) The preliminary audit report shall be signed and shall include the signature of any
1090	1090	1067pharmacist participating in the audit.
1091	1091	1068 (12) A pharmacy benefit manager shall not withhold payment to a pharmacy for
1092	1092	1069reimbursement claims as a means to recoup money until after the final internal disposition of an
1093	1093	1070audit, including the appeals process, as provided in subsection (b), unless fraud or
1094	1094	1071misrepresentation is reasonably suspected or the discrepant amount exceeds $15,000.
1095	1095	1072 (13) The auditor shall provide a copy of the final audit report to the pharmacy and plan
1096	1096	1073sponsor within 30 days following the pharmacy’s receipt of the signed preliminary audit report
1097	1097	1074or the completion of the appeals process, as provided in subsection (b), whichever is later.
1098	1098	1075 (14) No auditing company or agent shall receive payment based upon a percentage of the
1099	1099	1076amount recovered or other financial incentive tied to the findings of the audit.
1100	1100	1077 (b)(1) Each auditor shall establish an appeal process under which a pharmacy may appeal
1101	1101	1078findings in a preliminary audit.
1102	1102	1079 (2) To appeal a finding, a pharmacy may use the records of a hospital, physician or other
1103	1103	1080authorized prescriber to validate the record with respect to orders or refills of prescription drugs
1104	1104	1081or devices.
1105	1105	1082 (3) A pharmacy shall have 30 days to appeal any discrepancy found during the
1106	1106	1083preliminary audit. 52 of 58
1107	1107	1084 (4) The National Council for Prescription Drug Programs or any other recognized
1108	1108	1085national industry standard shall be used to evaluate claims submission and product size disputes.
1109	1109	1086 (5) If an audit results in the identification of any clerical or record-keeping errors in a
1110	1110	1087required document or record, the pharmacy shall not be subject to recoupment of funds by the
1111	1111	1088pharmacy benefit manager; provided, that the pharmacy may provide proof that the patient
1112	1112	1089received the medication billed to the plan via patient signature logs or other acceptable methods,
1113	1113	1090unless there is financial harm to the plan or errors that exceed the normal course of business.
1114	1114	1091 (c) This section shall not apply to any audit or investigation of a pharmacy that involves
1115	1115	1092potential fraud, willful misrepresentation or abuse, including, but not limited to, investigative
1116	1116	1093audits or any other statutory or regulatory provision which authorizes investigations relating to
1117	1117	1094insurance fraud.
1118	1118	1095 (d) This section shall not apply to a public health care payer, as defined in section 1 of
1119	1119	1096chapter 12C.
1120	1120	1097 (e) The commissioner shall promulgate regulations to enforce this section.
1121	1121	1098 Section 11. (a) The commissioner may make an examination of the affairs of a pharmacy
1122	1122	1099benefit manager when the commissioner deems prudent, but not less than once every 3 years.
1123	1123	1100The focus of the examination shall be to ensure that a pharmacy benefit manager is able to meet
1124	1124	1101its responsibilities under contracts with carriers. The examination shall be conducted in
1125	1125	1102accordance with subsection (6) of section 4 of chapter 175. 53 of 58
1126	1126	1103 (b) The commissioner, a deputy or an examiner may conduct an on-site examination of
1127	1127	1104each pharmacy benefit manager in the commonwealth to thoroughly inspect and examine its
1128	1128	1105affairs.
1129	1129	1106 (c) The charge for each such examination shall be determined annually in accordance
1130	1130	1107with subsection (6) of section 4 of chapter 175.
1131	1131	1108 (d) Not later than 60 days following completion of the examination, the examiner in
1132	1132	1109charge shall file with the commissioner a verified written report of examination under oath.
1133	1133	1110Upon receipt of the verified report, the commissioner shall transmit the report to the pharmacy
1134	1134	1111benefit manager examined with a notice that shall afford the pharmacy benefit manager
1135	1135	1112examined a reasonable opportunity of not more than 30 days to make a written submission or
1136	1136	1113rebuttal with respect to any matters contained in the examination report. Not later than 30 days
1137	1137	1114after the end of the period allowed for the receipt of written submissions or rebuttals, the
1138	1138	1115commissioner shall consider and review the reports together with any written submissions or
1139	1139	1116rebuttals and any relevant portions of the examiner’s work papers and enter an order:
1140	1140	1117 (i) adopting the examination report as filed with modifications or corrections and, if the
1141	1141	1118examination report reveals that the pharmacy benefit manager is operating in violation of this
1142	1142	1119section or any regulation or prior order of the commissioner, the commissioner may order the
1143	1143	1120pharmacy benefit manager to take any action the commissioner considers necessary and
1144	1144	1121appropriate to cure such violation;
1145	1145	1122 (ii) rejecting the examination report with directions to the examiners to reopen the
1146	1146	1123examination for the purposes of obtaining additional data, documentation or information and re-
1147	1147	1124filing pursuant to the above provisions; or 54 of 58
1148	1148	1125 (iii) calling for an investigatory hearing with no less than 20 days’ notice to the pharmacy
1149	1149	1126benefit manager for purposes of obtaining additional documentation, data, information and
1150	1150	1127testimony.
1151	1151	1128 (e) Notwithstanding any general or special law to the contrary, including clause Twenty-
1152	1152	1129sixth of section 7 of chapter 4 and section 10 of chapter 66, the records of any such examination
1153	1153	1130and the information contained in the records, reports or books of any pharmacy benefit manager
1154	1154	1131examined pursuant to this section shall be confidential and open only to the inspection of the
1155	1155	1132commissioner, or the examiners and assistants. Access to such confidential material may be
1156	1156	1133granted by the commissioner to law enforcement officials of the commonwealth or any other
1157	1157	1134state or agency of the federal government at any time, so long as the agency or office receiving
1158	1158	1135the information agrees in writing to keep such material confidential. Nothing herein shall be
1159	1159	1136construed to prohibit the required production of such records and information contained in the
1160	1160	1137reports of such company or organization before any court of the commonwealth or any master or
1161	1161	1138auditor appointed by any such court, in any criminal or civil proceeding, affecting such
1162	1162	1139pharmacy benefit manager, its officers, partners, directors or employees. The final report of any
1163	1163	1140such audit, examination or any other inspection by or on behalf of the division of insurance shall
1164	1164	1141be a public record.
1165	1165	1142 Section 12. A pharmacy benefit manager shall be required to submit to periodic audits by
1166	1166	1143a licensed carrier if the pharmacy benefit manager has entered into a contract with the carrier to
1167	1167	1144provide pharmacy benefits to the carrier or its members. The commissioner shall direct or
1168	1168	1145provide specifications for such audits. 55 of 58
1169	1169	1146 Section 13. (a) A contract between a pharmacy benefit manager and a pharmacy shall not
1170	1170	1147include any provision that prohibits, restricts or limits a pharmacy or its employed pharmacists’
1171	1171	1148ability to provide an insured with information on the amount of the insured’s cost-sharing for
1172	1172	1149such insured’s prescription drug and the clinical efficacy of a more affordable alternative drug if
1173	1173	1150one is available. No contract shall penalize a pharmacy or an individual pharmacist for disclosing
1174	1174	1151such information to an insured or for dispensing to an insured a more affordable alternative
1175	1175	1152prescription drug if one is available.
1176	1176	1153 (b) A pharmacy benefit manager shall not charge a pharmacy a fee related to the
1177	1177	1154adjudication of a claim unless such fee is set out in a contract between the pharmacy benefit
1178	1178	1155manager and the pharmacist or contracting agent or pharmacy, including, but not limited to, a fee
1179	1179	1156for: (i) the receipt and processing of a pharmacy claim; (ii) the development or management of
1180	1180	1157claims processing services in a pharmacy benefit manager network; or (iii) participation in a
1181	1181	1158pharmacy benefit manager network.
1182	1182	1159 (c) A contract between a pharmacy benefit manager and a pharmacy shall not include any
1183	1183	1160provision that prohibits, restricts or limits disclosure of information to the division deemed
1184	1184	1161necessary by the division to ensure a pharmacy benefit manager’s compliance with the
1185	1185	1162requirements under this section or section 21C of chapter 94C.
1186	1186	1163 SECTION 37. Sections 131 and 226 of chapter 139 of the acts of 2012 are hereby
1187	1187	1164repealed.
1188	1188	1165 SECTION 38. (a) Notwithstanding any general or special law to the contrary, the office
1189	1189	1166of pharmaceutical policy and analysis, in consultation with the office of Medicaid, shall conduct
1190	1190	1167an analysis and issue a report on the future of cell and gene therapy in the commonwealth with 56 of 58
1191	1191	1168the objective of addressing anticipated barriers to access that may exist with respect to such
1192	1192	1169treatments for patients covered by MassHealth programs and other vulnerable populations. The
1193	1193	1170analysis shall be focused on cell and gene therapy products, hereinafter referred to as products,
1194	1194	1171that are expected to come to market in the United States by the year 2035. The analysis and
1195	1195	1172report shall include, but not be limited to:
1196	1196	1173 (i) a projection of the estimated total number of products that are expected to come to
1197	1197	1174market in the United States;
1198	1198	1175 (ii) information on the diseases and conditions such products will be approved to treat,
1199	1199	1176including the total estimated number of impacted individuals in the commonwealth and the total
1200	1200	1177number of impacted individuals enrolled in MassHealth;
1201	1201	1178 (iii) an assessment of anticipated costs of coverage and existing reimbursement
1202	1202	1179frameworks and methodologies that may be employed by MassHealth for the products to the
1203	1203	1180extent the products are purchased by health care facilities for administration to MassHealth
1204	1204	1181beneficiaries during inpatient hospital stays;
1205	1205	1182 (iv) an assessment of whether the reimbursement frameworks and methodologies
1206	1206	1183identified pursuant to clause (iii) would lead to barriers to access to the products in light of the
1207	1207	1184projected costs to the health care system associated with the utilization of the products, and
1208	1208	1185whether such barriers to access, if any, would disproportionately impact MassHealth
1209	1209	1186beneficiaries or other vulnerable populations, including population groups that may be more
1210	1210	1187likely to have adverse health outcomes due to experience with historic disparities or
1211	1211	1188discrimination; and 57 of 58
1212	1212	1189 (v) an assessment of whether the current health care facility infrastructure necessary for
1213	1213	1190the administration of the products is adequate to ensure equitable access for patients in need of
1214	1214	1191treatment with the products.
1215	1215	1192 (b) To the extent that the analysis identifies any barriers to access to the products, the
1216	1216	1193office of pharmaceutical policy and analysis and the office of Medicaid shall analyze and report
1217	1217	1194on the reasons for such barriers and shall propose corrective policy solutions. If any identified
1218	1218	1195barriers are the result of or otherwise related to current MassHealth reimbursement
1219	1219	1196methodologies for the products, the report shall propose modifications designed to eliminate
1220	1220	1197such barriers to such methodologies to the extent authorized under federal law.
1221	1221	1198 (c) In conducting the analysis and producing the report required by this section, the health
1222	1222	1199office of pharmaceutical policy and analysis and the office of Medicaid shall consult with the
1223	1223	1200Massachusetts Biotechnology Council, Inc., the Massachusetts Health and Hospital Association,
1224	1224	1201Inc., the Conference of Boston Teaching Hospitals, Inc., the Massachusetts Association of
1225	1225	1202Health Plans, Inc., Blue Cross and Blue Shield of Massachusetts, Inc. and the rare disease
1226	1226	1203advisory council established pursuant to section 241 of chapter 111.
1227	1227	1204 (d) The report shall be made available electronically on the commission’s website and
1228	1228	1205shall be filed with the secretary of administration and finance, the clerks of the house of
1229	1229	1206representatives and the senate, the house and senate committees on ways and means and the joint
1230	1230	1207committee on health care financing by not later than July 31, 2025.
1231	1231	1208 SECTION 39. Section 17T of chapter 32A of the General Laws, inserted by section 27;
1232	1232	1209section 10R of chapter 118E of the General Laws, inserted by section 29; section 47VV of 175 of
1233	1233	1210the General Laws, inserted by section 30; section 8WW of 176A of the General Laws, inserted 58 of 58
1234	1234	1211by section 32; section 4WW of 176B of the General Laws, inserted by section 33; and section
1235	1235	12124OO of chapter 176G of the General Laws, inserted by section 34, shall apply with respect to
1236	1236	1213health benefit plans that are entered into, amended, extended or renewed on or after August 1,
1237	1237	12142025.
1238	1238	1215 SECTION 40. The center shall prepare the list required pursuant to section 10B of
1239	1239	1216chapter 12C, inserted by section 23, not later than March 31, 2026.
1240	1240	1217 SECTION 41. Section 31 of chapter 176O of the General Laws, inserted by section 35,
1241	1241	1218shall take effect on April 1, 2025. All carriers shall file the first annual report required by
1242	1242	1219subsection (d) of said section 31 of said chapter 176O of the General Laws not later than April 1,
1243	1243	12202026.
1244	1244	1221 SECTION 42. All entities performing pharmacy benefit management services shall be
1245	1245	1222licensed by the division of health insurance as pharmacy benefit managers pursuant to section 2
1246	1246	1223of chapter 176Y of the General Laws, inserted by section 36, not later than January 1, 2025.
1247	1247	1224 SECTION 43. Sections 7 to 9, inclusive, of chapter 176Y, inserted by section 36, shall
1248	1248	1225apply with respect to health benefit plans that are entered into, amended, extended or renewed on
1249	1249	1226or after August 1, 2025.; and
1250	1250	1227 by striking out the title and inserting in place thereof the following title: “An Act
1251	1251	1228promoting access and affordability of prescription drugs.”.