Massachusetts 2025-2026 Regular Session

Massachusetts House Bill H1296 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	1 of 1
2	2	HOUSE DOCKET, NO. 3592 FILED ON: 1/17/2025
3	3	HOUSE . . . . . . . . . . . . . . . No. 1296
4	4	The Commonwealth of Massachusetts
5	5	_________________
6	6	PRESENTED BY:
7	7	Sean Reid
8	8	_________________
9	9	To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General
10	10	Court assembled:
11	11	The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill:
12	12	An Act to protect 340B providers.
13	13	_______________
14	14	PETITION OF:
15	15	NAME:DISTRICT/ADDRESS :DATE ADDED:Sean Reid11th Essex1/17/2025 1 of 30
16	16	HOUSE DOCKET, NO. 3592 FILED ON: 1/17/2025
17	17	HOUSE . . . . . . . . . . . . . . . No. 1296
18	18	By Representative Reid of Lynn, a petition (accompanied by bill, House, No. 1296) of Sean Reid
19	19	relative to 340B pharmacies. Financial Services.
20	20	The Commonwealth of Massachusetts
21	21	_______________
22	22	In the One Hundred and Ninety-Fourth General Court
23	23	(2025-2026)
24	24	_______________
25	25	An Act to protect 340B providers.
26	26	Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority
27	27	of the same, as follows:
28	28	1 SECTION XX. Chapter 32A of the General Laws, as appearing in the 2020 Official
29	29	2Edition, is hereby amended by inserting after section 33, the following new section: -
30	30	3 Section 34.
31	31	4 (a) For purposes of this section:
32	32	5 (1) “340B drug” shall mean a drug that has been subject to any offer for reduced prices
33	33	6by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a covered entity as defined by
34	34	742 U.S.C. 256b(a)(4).
35	35	8 (2) “340B entity” shall mean an entity participating or authorized to participate in the
36	36	9federal 340B drug discount program, as defined by 42 U.S.C. 256b, including its pharmacy, or
37	37	10any pharmacy contracted with the participating entity to dispense drugs purchased through the
38	38	11340B drug discount program. 2 of 30
39	39	12 (3) “Health insurance issuer” shall mean the group insurance commission or a “carrier”
40	40	13as defined in section 1 of chapter 176O.
41	41	14 (4) “Third party” shall mean a group health plan, a health insurance issuer offering group
42	42	15or individual health insurance coverage, or a pharmacy benefit manager that reimburses a 340B
43	43	16covered entity for drugs. Third party includes Medicaid managed care organizations, employee
44	44	17benefit plans under the Employee Retirement Income Security Act of 1974, or Medicare Part C
45	45	18or D plans. Third party does not include drugs reimbursed under Medicaid fee-for-service or a
46	46	19self-pay patient.
47	47	20 (5) “Manufacturer” means a person who is engaged in manufacturing, preparing,
48	48	21propagating, compounding, processing, packaging, repackaging or labeling a prescription drug as
49	49	22defined in 247 CMR 2.00.
50	50	23 (6) “Pharmacy” incudes the definition of “pharmacy” and “retail drug business” as
51	51	24defined by section 1 of chapter 94C, and “Institutional pharmacy” as defined by section 39D of
52	52	25chapter 112.
53	53	26 (7) “Pharmacy benefit manager” shall have the same meaning as defined by section 226
54	54	27of chapter 175.
55	55	28 (b) With respect to reimbursement to a 340B entity for 340B drugs, a health insurance
56	56	29issuer, pharmacy benefit manager, other third party payor, or their agents shall not do any of the
57	57	30following: 3 of 30
58	58	31 (i) Reimburse a 340B entity for 340B drugs at a rate lower than that paid for the same
59	59	32drug to entities that are not 340B entities or lower reimbursement for a claim on the basis that the
60	60	33claim is for a 340B drug.
61	61	34 (ii) Impose any terms or conditions on any 340B entity with respect to any of the
62	62	35following that differ from such terms or conditions applied to non-340B entities on the basis that
63	63	36the entity participates in the federal 340B drug discount program set forth in 42 U.S.C.256b or
64	64	37that a drug is a 340B drug including, without limitation, any of the following:
65	65	38 A. Fees, charges, clawbacks, or other adjustments or assessments. For purposes of this
66	66	39Subsection, the term “other adjustment” includes placing any additional requirements,
67	67	40restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
68	68	41fees to the 340B entity that are not placed upon other entities that do not participate in the 340B
69	69	42drug discount program, including affiliate pharmacies of the health insurance issuer, pharmacy
70	70	43benefit manager, or other third-party payor.
71	71	44 B. Dispensing fees that are less than the dispensing fees for non-340B entities.
72	72	45 C. Restrictions or requirements regarding participation in standard or preferred pharmacy
73	73	46networks.
74	74	47 D. Requirements that a claim for a drug include any identification, billing modifier,
75	75	48attestation, or other indication that a drug is a 340B drug in order to be processed or resubmitted
76	76	49unless it is required by the Centers for Medicare and Medicaid Services, the executive office of
77	77	50health and human services, or the division of medical assistance. 4 of 30
78	78	51 E. Any other restrictions, conditions, practices, or policies that are not imposed on non-
79	79	52340B entities.
80	80	53 (iii) Require a 340B entity to reverse, resubmit, or clarify a claim after the initial
81	81	54adjudication unless these actions are in the normal course of pharmacy business and not related
82	82	55to 340B drug pricing.
83	83	56 (iv) Discriminate against a 340B entity in a manner that prevents or interferes with any
84	84	57patient’s choice to receive such drugs from the 340B entity, including the administration of such
85	85	58drugs. For purposes of this subsection, it is considered a discriminatory practice that prevents or
86	86	59interferes with a patient’s choice to receive drugs at a 340B entity if a health insurance issuer,
87	87	60pharmacy benefit manager, or other third-party payor places any additional requirements,
88	88	61restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
89	89	62fees to the 340B entity, including but not limited to requiring a claim for a drug to include any
90	90	63identification, billing modifier, attestation or other indication that a drug is a 340B drug in order
91	91	64to be processed or resubmitted unless it is required by the Centers for Medicare and Medicaid
92	92	65Services, the executive office of health and human services, or the division of medical assistance.
93	93	66 (v) Require a 340B entity to submit any claims, utilization, patient, or other data as a
94	94	67condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B
95	95	68entity unless the data is required by the United States Department of Health and Human Services,
96	96	69Centers for Medicare and Medicaid Services, the executive office of health and human services,
97	97	70or the division of medical assistance.
98	98	71 (vi) Include any other provision in a contract between a health insurance issuer, pharmacy
99	99	72benefit manager, or other third-party payor and a 340B entity that discriminates against the 340B 5 of 30
100	100	73entity or prevents or interferes with an individual’s choice to receive a prescription drug from a
101	101	74340B entity, including the administration of the drug, in person or via direct delivery, mail, or
102	102	75other form of shipment, or creation of a restriction or additional charge on a patient who chooses
103	103	76to receive drugs from a 340B entity.
104	104	77 (vii) Require or compel the submission of ingredient costs or pricing data pertaining to
105	105	78340B drugs to any health insurance issuer, pharmacy benefit manager, or other third-party payor.
106	106	79 (viii) Exclude any 340B entity from the health insurance issuer, pharmacy benefit
107	107	80manager, or other third party payor network on the basis that the 340B entity dispenses drugs
108	108	81subject to an agreement under 42 U.S.C.256b, or refusing to contract with a 340B entity for
109	109	82reasons other than those that apply equally to non-340B entities.
110	110	83 (ix) Nothing in this section applies to the division of medical assistance as payor when
111	111	84Medicaid provides reimbursement for covered outpatient drugs as defined in 42 U.S.C. 1396r-
112	112	858(9k)).
113	113	86 (c) With respect to manufacturing or distribution of drugs related to 340B entities:
114	114	87 (i) A manufacturer or distributor shall not deny, restrict, prohibit, or otherwise interfere
115	115	88with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug
116	116	89to, a pharmacy that is under contract with a 340B entity and is authorized under such contract to
117	117	90receive and dispense 340B drugs on behalf of the covered entity unless such receipt is prohibited
118	118	91by the United States Department of Health and Human Services.
119	119	92 (ii) A manufacturer or distributor shall not interfere with a pharmacy contracted with a
120	120	93340B entity. 6 of 30
121	121	94 (iii) A manufacturer or distributor shall not require a 340B entity to submit any claims,
122	122	95utilization, patient, or other data as a condition for allowing the acquisition of a 340B drug by, or
123	123	96delivery of a 340B drug to, a
124	124	97 340B entity unless the data is required by the United States Department of Health and
125	125	98Human Services.
126	126	99 SECTION XX. Chapter 175 of the General Laws, as appearing in the 2020 Official
127	127	100Edition, is hereby amended by inserting after section 47TT, the following new section:-
128	128	101 Section 47UU.
129	129	102 (a) For purposes of this section:
130	130	103 (1) “340B drug” shall mean a drug that has been subject to any offer for reduced prices
131	131	104by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a covered entity as defined by
132	132	10542 U.S.C. 256b(a)(4).
133	133	106 (2) “340B entity” shall mean an entity participating or authorized to participate in the
134	134	107federal 340B drug discount program, as defined by 42 U.S.C. 256b, including its pharmacy, or
135	135	108any pharmacy contracted with the participating entity to dispense drugs purchased through the
136	136	109340B drug discount program.
137	137	110 (3) “Health insurance issuer” shall mean “carrier” as defined in section 1 of chapter
138	138	111176O.
139	139	112 (4) “Third party” shall mean a group health plan, a health insurance issuer offering group
140	140	113or individual health insurance coverage, or a pharmacy benefit manager that reimburses a 340B
141	141	114covered entity for drugs. Third party includes Medicaid managed care organizations, employee 7 of 30
142	142	115benefit plans under the Employee Retirement Income Security Act of 1974, or Medicare Part C
143	143	116or D plans. Third party does not include drugs reimbursed under Medicaid fee-for-service or a
144	144	117self-pay patient.
145	145	118 (5) “Manufacturer” means a person who is engaged in manufacturing, preparing,
146	146	119propagating, compounding, processing, packaging, repackaging or labeling a prescription drug as
147	147	120defined in 247 CMR 2.00.
148	148	121 (6) “Pharmacy” incudes the definition of “pharmacy” and “retail drug business” as
149	149	122defined by section 1 of chapter 94C, and “Institutional pharmacy” as defined by section 39D of
150	150	123chapter 112.
151	151	124 (7) “Pharmacy benefit manager” shall have the same meaning as defined by section 226
152	152	125of chapter 175.
153	153	126 (b) With respect to reimbursement to a 340B entity for 340B drugs, a health insurance
154	154	127issuer, pharmacy benefit manager, other third party payor, or their agents shall not do any of the
155	155	128following:
156	156	129 (i) Reimburse a 340B entity for 340B drugs at a rate lower than that paid for the same
157	157	130drug to entities that are not 340B entities or lower reimbursement for a claim on the basis that the
158	158	131claim is for a 340B drug.
159	159	132 (ii) Impose any terms or conditions on any 340B entity with respect to any of the
160	160	133following that differ from such terms or conditions applied to non-340B entities on the basis that
161	161	134the entity participates in the federal 340B drug discount program set forth in 42 U.S.C.256b or
162	162	135that a drug is a 340B drug including, without limitation, any of the following: 8 of 30
163	163	136 A. Fees, charges, clawbacks, or other adjustments or assessments. For purposes of this
164	164	137Subsection, the term “other adjustment” includes placing any additional requirements,
165	165	138restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
166	166	139fees to the 340B entity that are not placed upon other entities that do not participate in the 340B
167	167	140drug discount program, including affiliate pharmacies of the health insurance issuer, pharmacy
168	168	141benefit manager, or other third-party payor.
169	169	142 B. Dispensing fees that are less than the dispensing fees for non-340B entities.
170	170	143 C. Restrictions or requirements regarding participation in standard or preferred pharmacy
171	171	144networks.
172	172	145 D. Restrictions or requirements regarding participation in standard or preferred pharmacy
173	173	146network.
174	174	147 E. Requirements that a claim for a drug include any identification, billing modifier,
175	175	148attestation, or other indication that a drug is a 340B drug in order to be processed or resubmitted
176	176	149unless it is required by the United States Department of Health and Human Services, Centers for
177	177	150Medicare and Medicaid Services, the executive office of health and human services, or the
178	178	151division of medical assistance.
179	179	152 F. Any other restrictions, conditions, practices, or policies that are not imposed on non-
180	180	153340B entities.
181	181	154 (iii) Require a 340B entity to reverse, resubmit, or clarify a claim after the initial
182	182	155adjudication unless these actions are in the normal course of pharmacy business and not related
183	183	156to 340B drug pricing. 9 of 30
184	184	157 (iv) Discriminate against a 340B entity in a manner that prevents or interferes with any
185	185	158patient’s choice to receive such drugs from the 340B entity, including the administration of such
186	186	159drugs. For purposes of this subsection, it is considered a discriminatory practice that prevents or
187	187	160interferes with a patient’s choice to receive drugs at a 340B entity if a health insurance issuer,
188	188	161pharmacy benefit manager, or other third-party payor places any additional requirements,
189	189	162restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
190	190	163fees to the 340B entity, including but not limited to requiring a claim for a drug to include any
191	191	164identification, billing modifier, attestation or other indication that a drug is a 340B drug in order
192	192	165to be processed or resubmitted unless it is required by the United States Department of Health
193	193	166and Human Services, Centers for Medicare and Medicaid Services, the executive office of health
194	194	167and human services, or the division of medical assistance.
195	195	168 (v) Require a 340B entity to submit any claims, utilization, patient, or other data as a
196	196	169condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B
197	197	170entity unless the data is required by the United States Department of Health and Human Services,
198	198	171Centers for Medicare and Medicaid Services, the executive office of health and human services,
199	199	172or the division of medical assistance.
200	200	173 (vi) Include any other provision in a contract between a health insurance issuer, pharmacy
201	201	174benefit manager, or other third-party payor and a 340B entity that discriminates against the 340B
202	202	175entity or prevents or interferes with an individual’s choice to receive a prescription drug from a
203	203	176340B entity, including the administration of the drug, in person or via direct delivery, mail, or
204	204	177other form of shipment, or creation of a restriction or additional charge on a patient who chooses
205	205	178to receive drugs from a 340B entity. 10 of 30
206	206	179 (vii) Require or compel the submission of ingredient costs or pricing data pertaining to
207	207	180340B drugs to any health insurance issuer, pharmacy benefit manager, or other third party payor.
208	208	181 (viii) Exclude any 340B entity from the health insurance issuer, pharmacy benefit
209	209	182manager, or other third party payor network on the basis that the 340B entity dispenses drugs
210	210	183subject to an agreement under 42 U.S.C.256b, or refusing to contract with a 340B entity for
211	211	184reasons other than those that apply equally to non-340B entities.
212	212	185 (ix) Nothing in this section applies to the division of medical assistance as payor when
213	213	186Medicaid provides reimbursement for covered outpatient drugs as defined in 42 U.S.C. 1396r-
214	214	1878(9k)).
215	215	188 (c) With respect to manufacturing or distribution of drugs related to 340B entities:
216	216	189 (i) A manufacturer or distributor shall not deny, restrict, prohibit, or otherwise interfere
217	217	190with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug
218	218	191to, a pharmacy that is under contract with a 340B entity and is authorized under such contract to
219	219	192receive and dispense 340B drugs on behalf of the covered entity unless such receipt is prohibited
220	220	193by the United States Department of Health and Human Services.
221	221	194 (ii) A manufacturer or distributor shall not interfere with a pharmacy contracted with a
222	222	195340B entity.
223	223	196 (iii) A manufacturer or distributor shall not require a 340B entity to submit any claims,
224	224	197utilization, patient, or other data as a condition for allowing the acquisition of a 340B drug by, or
225	225	198delivery of a 340B drug to, a 340B entity unless the data is required by the United States
226	226	199Department of Health and Human Services. 11 of 30
227	227	200 SECTION XX. Chapter 176A of the General Laws, as appearing in the 2020 Official
228	228	201Edition, is hereby amended by inserting after section 39, the following new section:-
229	229	202 Section 40.
230	230	203 (a) For purposes of this section:
231	231	204 (1) “340B drug” shall mean a drug that has been subject to any offer for reduced prices
232	232	205by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a covered entity as defined by
233	233	20642 U.S.C. 256b(a)(4).
234	234	207 (2) “340B entity” shall mean an entity participating or authorized to participate in the
235	235	208federal 340B drug discount program, as defined by 42 U.S.C. 256b, including its pharmacy, or
236	236	209any pharmacy contracted with the participating entity to dispense drugs purchased through the
237	237	210340B drug discount program.
238	238	211 (3) “Health insurance issuer” shall mean “carrier” as defined in section 1 of chapter
239	239	212176O.
240	240	213 (4) “Third party” shall mean a group health plan, a health insurance issuer offering group
241	241	214or individual health insurance coverage, or a pharmacy benefit manager that reimburses a 340B
242	242	215covered entity for drugs. Third party includes Medicaid managed care organizations, employee
243	243	216benefit plans under the Employee Retirement Income Security Act of 1974, or Medicare Part C
244	244	217or D plans. Third party does not include drugs reimbursed under Medicaid fee-for-service or a
245	245	218self-pay patient. 12 of 30
246	246	219 (5) “Manufacturer” means a person who is engaged in manufacturing, preparing,
247	247	220propagating, compounding, processing, packaging, repackaging or labeling a prescription drug as
248	248	221defined in 247 CMR 2.00.
249	249	222 (6) “Pharmacy” incudes the definition of “pharmacy” and “retail drug business” as
250	250	223defined by section 1 of chapter 94C, and “Institutional pharmacy” as defined by section 39D of
251	251	224chapter 112.
252	252	225 (7) “Pharmacy benefit manager” shall have the same meaning as defined by section 226
253	253	226of chapter 175.
254	254	227 (b) With respect to reimbursement to a 340B entity for 340B drugs, a health insurance
255	255	228issuer, pharmacy benefit manager, other third party payor, or their agents shall not do any of the
256	256	229following:
257	257	230 (i) Reimburse a 340B entity for 340B drugs at a rate lower than that paid for the same
258	258	231drug to entities that are not 340B entities or lower reimbursement for a claim on the basis that the
259	259	232claim is for a 340B drug.
260	260	233 (ii) Impose any terms or conditions on any 340B entity with respect to any of the
261	261	234following that differ from such terms or conditions applied to non-340B entities on the basis that
262	262	235the entity participates in the federal 340B drug discount program set forth in 42 U.S.C.256b or
263	263	236that a drug is a 340B drug including, without limitation, any of the following:
264	264	237 A. Fees, charges, clawbacks, or other adjustments or assessments. For purposes of this
265	265	238Subsection, the term “other adjustment” includes placing any additional requirements,
266	266	239restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or 13 of 30
267	267	240fees to the 340B entity that are not placed upon other entities that do not participate in the 340B
268	268	241drug discount program, including affiliate pharmacies of the health insurance issuer, pharmacy
269	269	242benefit manager, or other third-party payor.
270	270	243 B. Dispensing fees that are less than the dispensing fees for non-340B entities.
271	271	244 C. Restrictions or requirements regarding participation in standard or preferred pharmacy
272	272	245networks.
273	273	246 D. Restrictions or requirements regarding participation in standard or preferred pharmacy
274	274	247network.
275	275	248 E. Requirements that a claim for a drug include any identification, billing modifier,
276	276	249attestation, or other indication that a drug is a 340B drug in order to be processed or resubmitted
277	277	250unless it is required by the United States Department of Health and Human Services, Centers for
278	278	251Medicare and Medicaid Services, the executive office of health and human services, or the
279	279	252division of medical assistance.
280	280	253 F. Any other restrictions, conditions, practices, or policies that are not imposed on non-
281	281	254340B entities.
282	282	255 (iii) Require a 340B entity to reverse, resubmit, or clarify a claim after the initial
283	283	256adjudication unless these actions are in the normal course of pharmacy business and not related
284	284	257to 340B drug pricing.
285	285	258 (iv) Discriminate against a 340B entity in a manner that prevents or interferes with any
286	286	259patient’s choice to receive such drugs from the 340B entity, including the administration of such
287	287	260drugs. For purposes of this subsection, it is considered a discriminatory practice that prevents or 14 of 30
288	288	261interferes with a patient’s choice to receive drugs at a 340B entity if a health insurance issuer,
289	289	262pharmacy benefit manager, or other third-party payor places any additional requirements,
290	290	263restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
291	291	264fees to the 340B entity, including but not limited to requiring a claim for a drug to include any
292	292	265identification, billing modifier, attestation or other indication that a drug is a 340B drug in order
293	293	266to be processed or resubmitted unless it is required by the United States Department of Health
294	294	267and Human Services, Centers for Medicare and Medicaid Services, the executive office of health
295	295	268and human services, or the division of medical assistance.
296	296	269 (v) Require a 340B entity to submit any claims, utilization, patient, or other data as a
297	297	270condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B
298	298	271entity unless the data is required by the United States Department of Health and Human Services,
299	299	272Centers for Medicare and Medicaid Services, the executive office of health and human services,
300	300	273or the division of medical assistance.
301	301	274 (vi) Include any other provision in a contract between a health insurance issuer, pharmacy
302	302	275benefit manager, or other third-party payor and a 340B entity that discriminates against the 340B
303	303	276entity or prevents or interferes with an individual’s choice to receive a prescription drug from a
304	304	277340B entity, including the administration of the drug, in person or via direct delivery, mail, or
305	305	278other form of shipment, or creation of a restriction or additional charge on a patient who chooses
306	306	279to receive drugs from a 340B entity.
307	307	280 (vii) Require or compel the submission of ingredient costs or pricing data pertaining to
308	308	281340B drugs to any health insurance issuer, pharmacy benefit manager, or other third party payor. 15 of 30
309	309	282 (viii) Exclude any 340B entity from the health insurance issuer, pharmacy benefit
310	310	283manager, or other third party payor network on the basis that the 340B entity dispenses drugs
311	311	284subject to an agreement under 42 U.S.C.256b, or refusing to contract with a 340B entity for
312	312	285reasons other than those that apply equally to non-340B entities.
313	313	286 (ix) Nothing in this section applies to the division of medical assistance as payor when
314	314	287Medicaid provides reimbursement for covered outpatient drugs as defined in 42 U.S.C. 1396r-
315	315	2888(9k)).
316	316	289 (c) With respect to manufacturing or distribution of drugs related to 340B entities:
317	317	290 (i) A manufacturer or distributor shall not deny, restrict, prohibit, or otherwise interfere
318	318	291with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug
319	319	292to, a pharmacy that is under contract with a 340B entity and is authorized under such contract to
320	320	293receive and dispense 340B drugs on behalf of the covered entity unless such receipt is prohibited
321	321	294by the United States Department of Health and Human Services.
322	322	295 (ii) A manufacturer or distributor shall not interfere with a pharmacy contracted with a
323	323	296340B entity.
324	324	297 (iii) A manufacturer or distributor shall not require a 340B entity to submit any claims,
325	325	298utilization, patient, or other data as a condition for allowing the acquisition of a 340B drug by, or
326	326	299delivery of a 340B drug to, a 340B entity unless the data is required by the United States
327	327	300Department of Health and Human Services.
328	328	301 SECTION XX. Chapter 176B of the General Laws, as appearing in the 2020 Official
329	329	302Edition, is hereby further amended by inserting after section 26 the following new section: - 16 of 30
330	330	303 Section 27.
331	331	304 (a) For purposes of this section:
332	332	305 (1) “340B drug” shall mean a drug that has been subject to any offer for reduced prices
333	333	306by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a covered entity as defined by
334	334	30742 U.S.C. 256b(a)(4).
335	335	308 (2) “340B entity” shall mean an entity participating or authorized to participate in the
336	336	309federal 340B drug discount program, as defined by 42 U.S.C. 256b, including its pharmacy, or
337	337	310any pharmacy contracted with the participating entity to dispense drugs purchased through the
338	338	311340B drug discount program.
339	339	312 (3) “Health insurance issuer” shall mean “carrier” as defined in section 1 of chapter
340	340	313176O.
341	341	314 (4) “Third party” shall mean a group health plan, a health insurance issuer offering group
342	342	315or individual health insurance coverage, or a pharmacy benefit manager that reimburses a 340B
343	343	316covered entity for drugs. Third party includes Medicaid managed care organizations, employee
344	344	317benefit plans under the Employee Retirement Income Security Act of 1974, or Medicare Part C
345	345	318or D plans. Third party does not include drugs reimbursed under Medicaid fee-for-service or a
346	346	319self-pay patient.
347	347	320 (5) “Manufacturer” means a person who is engaged in manufacturing, preparing,
348	348	321propagating, compounding, processing, packaging, repackaging or labeling a prescription drug as
349	349	322defined in 247 CMR 2.00. 17 of 30
350	350	323 (6) “Pharmacy” incudes the definition of “pharmacy” and “retail drug business” as
351	351	324defined by section 1 of chapter 94C, and “Institutional pharmacy” as defined by section 39D of
352	352	325chapter 112.
353	353	326 (7) “Pharmacy benefit manager” shall have the same meaning as defined by section 226
354	354	327of chapter 175.
355	355	328 (b) With respect to reimbursement to a 340B entity for 340B drugs, a health insurance
356	356	329issuer, pharmacy benefit manager, other third party payor, or their agents shall not do any of the
357	357	330following:
358	358	331 (i) Reimburse a 340B entity for 340B drugs at a rate lower than that paid for the same
359	359	332drug to entities that are not 340B entities or lower reimbursement for a claim on the basis that the
360	360	333claim is for a 340B drug.
361	361	334 (ii) Impose any terms or conditions on any 340B entity with respect to any of the
362	362	335following that differ from such terms or conditions applied to non-340B entities on the basis that
363	363	336the entity participates in the federal 340B drug discount program set forth in 42 U.S.C.256b or
364	364	337that a drug is a 340B drug including, without limitation, any of the following:
365	365	338 A. Fees, charges, clawbacks, or other adjustments or assessments. For purposes of this
366	366	339Subsection, the term “other adjustment” includes placing any additional requirements,
367	367	340restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
368	368	341fees to the 340B entity that are not placed upon other entities that do not participate in the 340B
369	369	342drug discount program, including affiliate pharmacies of the health insurance issuer, pharmacy
370	370	343benefit manager, or other third-party payor. 18 of 30
371	371	344 B. Dispensing fees that are less than the dispensing fees for non-340B entities.
372	372	345 C. Restrictions or requirements regarding participation in standard or preferred pharmacy
373	373	346networks.
374	374	347 D. Restrictions or requirements regarding participation in standard or preferred pharmacy
375	375	348network.
376	376	349 E. Requirements that a claim for a drug include any identification, billing modifier,
377	377	350attestation, or other indication that a drug is a 340B drug in order to be processed or resubmitted
378	378	351unless it is required by the United States Department of Health and Human Services, Centers for
379	379	352Medicare and Medicaid Services, the executive office of health and human services, or the
380	380	353division of medical assistance.
381	381	354 F. Any other restrictions, conditions, practices, or policies that are not imposed on non-
382	382	355340B entities.
383	383	356 (iii) Require a 340B entity to reverse, resubmit, or clarify a claim after the initial
384	384	357adjudication unless these actions are in the normal course of pharmacy business and not related
385	385	358to 340B drug pricing.
386	386	359 (iv) Discriminate against a 340B entity in a manner that prevents or interferes with any
387	387	360patient’s choice to receive such drugs from the 340B entity, including the administration of such
388	388	361drugs. For purposes of this subsection, it is considered a discriminatory practice that prevents or
389	389	362interferes with a patient’s choice to receive drugs at a 340B entity if a health insurance issuer,
390	390	363pharmacy benefit manager, or other third-party payor places any additional requirements,
391	391	364restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or 19 of 30
392	392	365fees to the 340B entity, including but not limited to requiring a claim for a drug to include any
393	393	366identification, billing modifier, attestation or other indication that a drug is a 340B drug in order
394	394	367to be processed or resubmitted unless it is required by the United States Department of Health
395	395	368and Human Services, Centers for Medicare and Medicaid Services, the executive office of health
396	396	369and human services, or the division of medical assistance.
397	397	370 (v) Require a 340B entity to submit any claims, utilization, patient, or other data as a
398	398	371condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B
399	399	372entity unless the data is required by the United States Department of Health and Human Services,
400	400	373Centers for Medicare and Medicaid Services, the executive office of health and human services,
401	401	374or the division of medical assistance.
402	402	375 (vi) Include any other provision in a contract between a health insurance issuer, pharmacy
403	403	376benefit manager, or other third-party payor and a 340B entity that discriminates against the 340B
404	404	377entity or prevents or interferes with an individual’s choice to receive a prescription drug from a
405	405	378340B entity, including the administration of the drug, in person or via direct delivery, mail, or
406	406	379other form of shipment, or creation of a restriction or additional charge on a patient who chooses
407	407	380to receive drugs from a 340B entity.
408	408	381 (vii) Require or compel the submission of ingredient costs or pricing data pertaining to
409	409	382340B drugs to any health insurance issuer, pharmacy benefit manager, or other third party payor.
410	410	383 (viii) Exclude any 340B entity from the health insurance issuer, pharmacy benefit
411	411	384manager, or other third party payor network on the basis that the 340B entity dispenses drugs
412	412	385subject to an agreement under 42 U.S.C.256b, or refusing to contract with a 340B entity for
413	413	386reasons other than those that apply equally to non-340B entities. 20 of 30
414	414	387 (ix) Nothing in this section applies to the division of medical assistance as payor when
415	415	388Medicaid provides reimbursement for covered outpatient drugs as defined in 42 U.S.C. 1396r-
416	416	3898(9k)).
417	417	390 (c) With respect to manufacturing or distribution of drugs related to 340B entities:
418	418	391 (i) A manufacturer or distributor shall not deny, restrict, prohibit, or otherwise interfere
419	419	392with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug
420	420	393to, a pharmacy that is under contract with a 340B entity and is authorized under such contract to
421	421	394receive and dispense 340B drugs on behalf of the covered entity unless such receipt is prohibited
422	422	395by the United States Department of Health and Human Services.
423	423	396 (ii) A manufacturer or distributor shall not interfere with a pharmacy contracted with a
424	424	397340B entity.
425	425	398 (iii) A manufacturer or distributor shall not require a 340B entity to submit any claims,
426	426	399utilization, patient, or other data as a condition for allowing the acquisition of a 340B drug by, or
427	427	400delivery of a 340B drug to, a 340B entity unless the data is required by the United States
428	428	401Department of Health and Human Services.
429	429	402 SECTION XX. Chapter 176G of the General Laws, as appearing in the 2020 Official
430	430	403Edition, is hereby further amended by inserting after section 34 the following new section:-
431	431	404 Section 35.
432	432	405 (a) For purposes of this section: 21 of 30
433	433	406 (1) “340B drug” shall mean a drug that has been subject to any offer for reduced prices
434	434	407by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a covered entity as defined by
435	435	40842 U.S.C. 256b(a)(4).
436	436	409 (2) “340B entity” shall mean an entity participating or authorized to participate in the
437	437	410federal 340B drug discount program, as defined by 42 U.S.C. 256b, including its pharmacy, or
438	438	411any pharmacy contracted with the participating entity to dispense drugs purchased through the
439	439	412340B drug discount program.
440	440	413 (3) “Health insurance issuer” shall mean “carrier” as defined in section 1 of chapter
441	441	414176O.
442	442	415 (4) “Third party” shall mean a group health plan, a health insurance issuer offering group
443	443	416or individual health insurance coverage, or a pharmacy benefit manager that reimburses a 340B
444	444	417covered entity for drugs. Third party includes Medicaid managed care organizations, employee
445	445	418benefit plans under the Employee Retirement Income Security Act of 1974, or Medicare Part C
446	446	419or D plans. Third party does not include drugs reimbursed under Medicaid fee-for-service or a
447	447	420self-pay patient.
448	448	421 (5) “Manufacturer” means a person who is engaged in manufacturing, preparing,
449	449	422propagating, compounding, processing, packaging, repackaging or labeling a prescription drug as
450	450	423defined in 247 CMR 2.00.
451	451	424 (6) “Pharmacy” incudes the definition of “pharmacy” and “retail drug business” as
452	452	425defined by section 1 of chapter 94C, and “Institutional pharmacy” as defined by section 39D of
453	453	426chapter 112. 22 of 30
454	454	427 (7) “Pharmacy benefit manager” shall have the same meaning as defined by section 226
455	455	428of chapter 175.
456	456	429 (b) With respect to reimbursement to a 340B entity for 340B drugs, a health insurance
457	457	430issuer, pharmacy benefit manager, other third party payor, or their agents shall not do any of the
458	458	431following:
459	459	432 (i)Reimburse a 340B entity for 340B drugs at a rate lower than that paid for the same
460	460	433drug to entities that are not 340B entities or lower reimbursement for a claim on the basis that the
461	461	434claim is for a 340B drug.
462	462	435 (ii) Impose any terms or conditions on any 340B entity with respect to any of the
463	463	436following that differ from such terms or conditions applied to non-340B entities on the basis that
464	464	437the entity participates in the federal 340B drug discount program set forth in 42 U.S.C.256b or
465	465	438that a drug is a 340B drug including, without limitation, any of the following:
466	466	439 A. Fees, charges, clawbacks, or other adjustments or assessments. For purposes of this
467	467	440Subsection, the term “other adjustment” includes placing any additional requirements,
468	468	441restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
469	469	442fees to the 340B entity that are not placed upon other entities that do not participate in the 340B
470	470	443drug discount program, including affiliate pharmacies of the health insurance issuer, pharmacy
471	471	444benefit manager, or other third-party payor.
472	472	445 B. Dispensing fees that are less than the dispensing fees for non-340B entities.
473	473	446 C. Restrictions or requirements regarding participation in standard or preferred pharmacy
474	474	447networks. 23 of 30
475	475	448 D. Restrictions or requirements regarding participation in standard or preferred pharmacy
476	476	449network.
477	477	450 E. Requirements that a claim for a drug include any identification, billing modifier,
478	478	451attestation, or other indication that a drug is a 340B drug in order to be processed or resubmitted
479	479	452unless it is required by the United States Department of Health and Human Services, Centers for
480	480	453Medicare and Medicaid Services, the executive office of health and human services, or the
481	481	454division of medical assistance.
482	482	455 F. Any other restrictions, conditions, practices, or policies that are not imposed on non-
483	483	456340B entities.
484	484	457 (iii) Require a 340B entity to reverse, resubmit, or clarify a claim after the initial
485	485	458adjudication unless these actions are in the normal course of pharmacy business and not related
486	486	459to 340B drug pricing.
487	487	460 (iv) Discriminate against a 340B entity in a manner that prevents or interferes with any
488	488	461patient’s choice to receive such drugs from the 340B entity, including the administration of such
489	489	462drugs. For purposes of this subsection, it is considered a discriminatory practice that prevents or
490	490	463interferes with a patient’s choice to receive drugs at a 340B entity if a health insurance issuer,
491	491	464pharmacy benefit manager, or other third-party payor places any additional requirements,
492	492	465restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
493	493	466fees to the 340B entity, including but not limited to requiring a claim for a drug to include any
494	494	467identification, billing modifier, attestation or other indication that a drug is a 340B drug in order
495	495	468to be processed or resubmitted unless it is required by the United States Department of Health 24 of 30
496	496	469and Human Services, Centers for Medicare and Medicaid Services, the executive office of health
497	497	470and human services, or the division of medical assistance.
498	498	471 (v) Require a 340B entity to submit any claims, utilization, patient, or other data as a
499	499	472condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B
500	500	473entity unless the data is required by the United States Department of Health and Human Services,
501	501	474Centers for Medicare and Medicaid Services, the executive office of health and human services,
502	502	475or the division of medical assistance.
503	503	476 (vi) Include any other provision in a contract between a health insurance issuer, pharmacy
504	504	477benefit manager, or other third-party payor and a 340B entity that discriminates against the 340B
505	505	478entity or prevents or interferes with an individual’s choice to receive a prescription drug from a
506	506	479340B entity, including the administration of the drug, in person or via direct delivery, mail, or
507	507	480other form of shipment, or creation of a restriction or additional charge on a patient who chooses
508	508	481to receive drugs from a 340B entity.
509	509	482 (vii) Require or compel the submission of ingredient costs or pricing data pertaining to
510	510	483340B drugs to any health insurance issuer, pharmacy benefit manager, or other third party payor.
511	511	484 (viii) Exclude any 340B entity from the health insurance issuer, pharmacy benefit
512	512	485manager, or other third party payor network on the basis that the 340B entity dispenses drugs
513	513	486subject to an agreement under 42 U.S.C.256b, or refusing to contract with a 340B entity for
514	514	487reasons other than those that apply equally to non-340B entities.
515	515	488 (ix) Nothing in this section applies to the division of medical assistance as payor when
516	516	489Medicaid provides reimbursement for covered outpatient drugs as defined in 42 U.S.C. 1396r-
517	517	4908(9k)). 25 of 30
518	518	491 (c) With respect to manufacturing or distribution of drugs related to 340B entities:
519	519	492 (i) A manufacturer or distributor shall not deny, restrict, prohibit, or otherwise interfere
520	520	493with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug
521	521	494to, a pharmacy that is under contract with a 340B entity and is authorized under such contract to
522	522	495receive and dispense 340B drugs on behalf of the covered entity unless such receipt is prohibited
523	523	496by the United States Department of Health and Human Services.
524	524	497 (ii) A manufacturer or distributor shall not interfere with a pharmacy contracted with a
525	525	498340B entity.
526	526	499 (iii) A manufacturer or distributor shall not require a 340B entity to submit any claims,
527	527	500utilization, patient, or other data as a condition for allowing the acquisition of a 340B drug by, or
528	528	501delivery of a 340B drug to, a 340B entity unless the data is required by the United States
529	529	502Department of Health and Human Services.
530	530	503 SECTION XX. Chapter 176I of the General Laws, as appearing in the 2020 Official
531	531	504Edition, is hereby amended by inserting after section 14 the following new section: -
532	532	505 Section 15.
533	533	506 (a) For purposes of this section:
534	534	507 (1) “340B drug” shall mean a drug that has been subject to any offer for reduced prices
535	535	508by a manufacturer pursuant to 42 U.S.C. 256b and is purchased by a covered entity as defined by
536	536	50942 U.S.C. 256b(a)(4).
537	537	510 (2) “340B entity” shall mean an entity participating or authorized to participate in the
538	538	511federal 340B drug discount program, as defined by 42 U.S.C. 256b, including its pharmacy, or 26 of 30
539	539	512any pharmacy contracted with the participating entity to dispense drugs purchased through the
540	540	513340B drug discount program.
541	541	514 (3) “Health insurance issuer” shall mean “carrier” as defined in section 1 of chapter
542	542	515176O.
543	543	516 (4) “Third party” shall mean a group health plan, a health insurance issuer offering group
544	544	517or individual health insurance coverage, or a pharmacy benefit manager that reimburses a 340B
545	545	518covered entity for drugs. Third party includes Medicaid managed care organizations, employee
546	546	519benefit plans under the Employee Retirement Income Security Act of 1974, or Medicare Part C
547	547	520or D plans. Third party does not include drugs reimbursed under Medicaid fee-for-service or a
548	548	521self-pay patient.
549	549	522 (5) “Manufacturer” means a person who is engaged in manufacturing, preparing,
550	550	523propagating, compounding, processing, packaging, repackaging or labeling a prescription drug as
551	551	524defined in 247 CMR 2.00.
552	552	525 (6) “Pharmacy” incudes the definition of “pharmacy” and “retail drug business” as
553	553	526defined by section 1 of chapter 94C, and “Institutional pharmacy” as defined by section 39D of
554	554	527chapter 112.
555	555	528 (7) “Pharmacy benefit manager” shall have the same meaning as defined by section 226
556	556	529of chapter 175.
557	557	530 (b) With respect to reimbursement to a 340B entity for 340B drugs, a health insurance
558	558	531issuer, pharmacy benefit manager, other third party payor, or their agents shall not do any of the
559	559	532following: 27 of 30
560	560	533 (i) Reimburse a 340B entity for 340B drugs at a rate lower than that paid for the same
561	561	534drug to entities that are not 340B entities or lower reimbursement for a claim on the basis that the
562	562	535claim is for a 340B drug.
563	563	536 (ii) Impose any terms or conditions on any 340B entity with respect to any of the
564	564	537following that differ from such terms or conditions applied to non-340B entities on the basis that
565	565	538the entity participates in the federal 340B drug discount program set forth in 42 U.S.C.256b or
566	566	539that a drug is a 340B drug including, without limitation, any of the following:
567	567	540 A. Fees, charges, clawbacks, or other adjustments or assessments. For purposes of this
568	568	541Subsection, the term “other adjustment” includes placing any additional requirements,
569	569	542restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
570	570	543fees to the 340B entity that are not placed upon other entities that do not participate in the 340B
571	571	544drug discount program, including affiliate pharmacies of the health insurance issuer, pharmacy
572	572	545benefit manager, or other third-party payor.
573	573	546 B. Dispensing fees that are less than the dispensing fees for non-340B entities.
574	574	547 C. Restrictions or requirements regarding participation in standard or preferred pharmacy
575	575	548networks.
576	576	549 D. Restrictions or requirements regarding participation in standard or preferred pharmacy
577	577	550network.
578	578	551 E. Requirements that a claim for a drug include any identification, billing modifier,
579	579	552attestation, or other indication that a drug is a 340B drug in order to be processed or resubmitted
580	580	553unless it is required by the United States Department of Health and Human Services, Centers for 28 of 30
581	581	554Medicare and Medicaid Services, the executive office of health and human services, or the
582	582	555division of medical assistance.
583	583	556 F. Any other restrictions, conditions, practices, or policies that are not imposed on non-
584	584	557340B entities.
585	585	558 (iii) Require a 340B entity to reverse, resubmit, or clarify a claim after the initial
586	586	559adjudication unless these actions are in the normal course of pharmacy business and not related
587	587	560to 340B drug pricing.
588	588	561 (iv) Discriminate against a 340B entity in a manner that prevents or interferes with any
589	589	562patient’s choice to receive such drugs from the 340B entity, including the administration of such
590	590	563drugs. For purposes of this subsection, it is considered a discriminatory practice that prevents or
591	591	564interferes with a patient’s choice to receive drugs at a 340B entity if a health insurance issuer,
592	592	565pharmacy benefit manager, or other third-party payor places any additional requirements,
593	593	566restrictions, or unnecessary burdens upon the 340B entity that results in administrative costs or
594	594	567fees to the 340B entity, including but not limited to requiring a claim for a drug to include any
595	595	568identification, billing modifier, attestation or other indication that a drug is a 340B drug in order
596	596	569to be processed or resubmitted unless it is required by the United States Department of Health
597	597	570and Human Services, Centers for Medicare and Medicaid Services, the executive office of health
598	598	571and human services, or the division of medical assistance.
599	599	572 (v) Require a 340B entity to submit any claims, utilization, patient, or other data as a
600	600	573condition for allowing the acquisition of a 340B drug by, or delivery of a 340B drug to, a 340B
601	601	574entity unless the data is required by the United States Department of Health and Human Services, 29 of 30
602	602	575Centers for Medicare and Medicaid Services, the executive office of health and human services,
603	603	576or the division of medical assistance.
604	604	577 (vi) Include any other provision in a contract between a health insurance issuer, pharmacy
605	605	578benefit manager, or other third-party payor and a 340B entity that discriminates against the 340B
606	606	579entity or prevents or interferes with an individual’s choice to receive a prescription drug from a
607	607	580340B entity, including the administration of the drug, in person or via direct delivery, mail, or
608	608	581other form of shipment, or creation of a restriction or additional charge on a patient who chooses
609	609	582to receive drugs from a 340B entity.
610	610	583 (vii) Require or compel the submission of ingredient costs or pricing data pertaining to
611	611	584340B drugs to any health insurance issuer, pharmacy benefit manager, or other third party payor.
612	612	585 (viii) Exclude any 340B entity from the health insurance issuer, pharmacy benefit
613	613	586manager, or other third party payor network on the basis that the 340B entity dispenses drugs
614	614	587subject to an agreement under 42 U.S.C.256b, or refusing to contract with a 340B entity for
615	615	588reasons other than those that apply equally to non-340B entities.
616	616	589 (ix) Nothing in this section applies to the division of medical assistance as payor when
617	617	590Medicaid provides reimbursement for covered outpatient drugs as defined in 42 U.S.C. 1396r-
618	618	5918(9k)).
619	619	592 (c) With respect to manufacturing or distribution of drugs related to 340B entities:
620	620	593 (i) A manufacturer or distributor shall not deny, restrict, prohibit, or otherwise interfere
621	621	594with, either directly or indirectly, the acquisition of a 340B drug by, or delivery of a 340B drug
622	622	595to, a pharmacy that is under contract with a 340B entity and is authorized under such contract to 30 of 30
623	623	596receive and dispense 340B drugs on behalf of the covered entity unless such receipt is prohibited
624	624	597by the United States Department of Health and Human Services.
625	625	598 (ii) A manufacturer or distributor shall not interfere with a pharmacy contracted with a
626	626	599340B entity.
627	627	600 (iii) A manufacturer or distributor shall not require a 340B entity to submit any claims,
628	628	601utilization, patient, or other data as a condition for allowing the acquisition of a 340B drug by, or
629	629	602delivery of a 340B drug to, a 340B entity unless the data is required by the United States
630	630	603Department of Health and Human Services.