Minnesota 2025-2026 Regular Session

Minnesota House Bill HF3054 Compare Versions

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1	1	1.1 A bill for an act
2	2	1.2 relating to health; modifying provisions for prescription drug transparency;
3	3	1.3 amending Minnesota Statutes 2024, sections 62J.461, subdivisions 3, 4, 5; 62J.84,
4	4	1.4 subdivisions 2, 3, 6, 10, 11, 12, 13, 14, 15.
5	5	1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
6	6	1.6 Section 1. Minnesota Statutes 2024, section 62J.461, subdivision 3, is amended to read:
7	7	1.7 Subd. 3.Reporting by covered entities to the commissioner.(a) Each 340B covered
8	8	1.8entity shall report to the commissioner by April 1 of each year the following information
9	9	1.9for transactions conducted by the 340B covered entity or on its behalf, and related to its
10	10	1.10participation in the federal 340B program for the previous calendar year:
11	11	1.11 (1) the aggregated acquisition cost for prescription drugs obtained under the 340B
12	12	1.12program;
13	13	1.13 (2) the aggregated payment amount received for drugs obtained under the 340B program
14	14	1.14and dispensed or administered to patients;:
15	15	1.15 (i) that are net of the contracted price for insurance claims payments; and
16	16	1.16 (ii) that reflect the portion of payment received from grants, cash, or other payment types
17	17	1.17that relate to the dispensing or administering of drugs obtained under the 340B program;
18	18	1.18 (3) the number of pricing units dispensed or administered for prescription drugs described
19	19	1.19in clause (2); and
20	20	1.20 (4) the aggregated payments made:
21	21	1.21 (i) to contract pharmacies to dispense drugs obtained under the 340B program;
22	22	1Section 1.
23	23	REVISOR EB/VJ 25-0030401/30/25
24	24	State of Minnesota
25	25	This Document can be made available
26	26	in alternative formats upon request
27	27	HOUSE OF REPRESENTATIVES
28	28	H. F. No. 3054
29	29	NINETY-FOURTH SESSION
30	30	Authored by Bierman04/02/2025
31	31	The bill was read for the first time and referred to the Committee on Health Finance and Policy 2.1 (ii) to any other entity that is not the covered entity and is not a contract pharmacy for
32	32	2.2managing any aspect of the covered entity's 340B program; and
33	33	2.3 (iii) for all other internal, direct expenses related to administering the 340B program
34	34	2.4with a detailed description of the direct costs included.
35	35	2.5The information under clauses (2) and (3) must be reported by payer type, including but
36	36	2.6not limited to commercial insurance, medical assistance, MinnesotaCare, and Medicare, in
37	37	2.7the form and manner prescribed by the commissioner.
38	38	2.8 (b) For covered entities that are hospitals, the information required under paragraph (a),
39	39	2.9clauses (1) to (3), must also be reported at the national drug code level for the 50 most
40	40	2.10frequently dispensed or administered drugs by the facility under the 340B program.
41	41	2.11 (c) Data submitted to the commissioner under paragraphs (a) and (b) are classified as
42	42	2.12nonpublic data, as defined in section 13.02, subdivision 9.
43	43	2.13 Sec. 2. Minnesota Statutes 2024, section 62J.461, subdivision 4, is amended to read:
44	44	2.14 Subd. 4.Enforcement and exceptions.(a) Any health care covered entity subject to
45	45	2.15reporting under this section that fails to provide data in the form and manner prescribed by
46	46	2.16the commissioner is subject to the levy of a fine paid to the commissioner of up to $500 for
47	47	2.17each day the data are past due. Any fine levied against the entity under this subdivision is
48	48	2.18subject to the contested case and judicial review provisions of sections 14.57 and to 14.69.
49	49	2.19 (b) The commissioner may grant an entity an extension of or exemption from the reporting
50	50	2.20obligations under this subdivision section, upon a showing of good cause by the entity.
51	51	2.21 Sec. 3. Minnesota Statutes 2024, section 62J.461, subdivision 5, is amended to read:
52	52	2.22 Subd. 5.Reports to the legislature.By November 15, 2024, and by November 15 of
53	53	2.23each year thereafter, the commissioner shall submit to the chairs and ranking minority
54	54	2.24members of the legislative committees with jurisdiction over health care finance and policy,
55	55	2.25a report that aggregates the data submitted under subdivision 3, paragraphs (a) and (b). The
56	56	2.26following information must be included in the report For all 340B entities whose net 340B
57	57	2.27revenue constitutes a significant share, as determined by the commissioner, of all net 340B
58	58	2.28revenue across all 340B covered entities in Minnesota, the following information must also
59	59	2.29be included in the report:
60	60	2.30 (1) the information submitted under subdivision 2; and
61	61	2Sec. 3.
62	62	REVISOR EB/VJ 25-0030401/30/25 3.1 (2) for each 340B entity identified in subdivision 2, that entity's 340B net revenue as
63	63	3.2calculated using the data submitted under subdivision 3, paragraph (a), with net revenue
64	64	3.3being subdivision 3, paragraph (a), clause (2), less the sum of subdivision 3, paragraph (a),
65	65	3.4clauses (1) and (4).
66	66	3.5For all other entities, the data in the report must be aggregated to the entity type or groupings
67	67	3.6of entity types in a manner that prevents the identification of an individual entity and any
68	68	3.7entity's specific data value reported for an individual data element.
69	69	3.8 Sec. 4. Minnesota Statutes 2024, section 62J.84, subdivision 2, is amended to read:
70	70	3.9 Subd. 2.Definitions.(a) For purposes of this section, the terms defined in this subdivision
71	71	3.10have the meanings given.
72	72	3.11 (b) "Biosimilar" means a drug that is produced or distributed pursuant to a biologics
73	73	3.12license application approved under United States Code, title 42, section 262(K)(3).
74	74	3.13 (c) "Brand name drug" means a drug that is produced or distributed pursuant to:
75	75	3.14 (1) a new drug application approved under United States Code, title 21, section 355(c),
76	76	3.15except for a generic drug as defined under Code of Federal Regulations, title 42, section
77	77	3.16447.502; or
78	78	3.17 (2) a biologics license application approved under United States Code, title 42, section
79	79	3.18262(a)(c).
80	80	3.19 (d) "Commissioner" means the commissioner of health.
81	81	3.20 (e) "Generic drug" means a drug that is marketed or distributed pursuant to:
82	82	3.21 (1) an abbreviated new drug application approved under United States Code, title 21,
83	83	3.22section 355(j);
84	84	3.23 (2) an authorized generic as defined under Code of Federal Regulations, title 42, section
85	85	3.24447.502; or
86	86	3.25 (3) a drug that entered the market the year before 1962 and was not originally marketed
87	87	3.26under a new drug application.
88	88	3.27 (f) "Manufacturer" means a drug manufacturer licensed under section 151.252.
89	89	3.28 (g) "New prescription drug" or "new drug" means a prescription drug approved for
90	90	3.29marketing by the United States Food and Drug Administration (FDA) for which no previous
91	91	3.30wholesale acquisition cost has been established for comparison.
92	92	3Sec. 4.
93	93	REVISOR EB/VJ 25-0030401/30/25 4.1 (h) "Patient assistance program" means a program that a manufacturer offers to the public
94	94	4.2in which a consumer may reduce the consumer's out-of-pocket costs for prescription drugs
95	95	4.3by using coupons, discount cards, prepaid gift cards, manufacturer debit cards, or by other
96	96	4.4means.
97	97	4.5 (i) "Prescription drug" or "drug" has the meaning provided in section 151.441, subdivision
98	98	4.68.
99	99	4.7 (j) "Price" means the wholesale acquisition cost as defined in United States Code, title
100	100	4.842, section 1395w-3a(c)(6)(B).
101	101	4.9 (k) "30-day supply" means the total daily dosage units of a prescription drug
102	102	4.10recommended by the prescribing label approved by the FDA for 30 days. If the
103	103	4.11FDA-approved prescribing label includes more than one recommended daily dosage, the
104	104	4.1230-day supply is based on the maximum recommended daily dosage on the FDA-approved
105	105	4.13prescribing label.
106	106	4.14 (l) "Course of treatment" means the total dosage of a single prescription for a prescription
107	107	4.15drug recommended by the FDA-approved prescribing label. If the FDA-approved prescribing
108	108	4.16label includes more than one recommended dosage for a single course of treatment, the
109	109	4.17course of treatment is the maximum recommended dosage on the FDA-approved prescribing
110	110	4.18label.
111	111	4.19 (m) "Drug product family" means a group of one or more prescription drugs that share
112	112	4.20a unique generic drug description or nontrade name and dosage form.
113	113	4.21 (n) "Individual salable unit" means the smallest container of product introduced into
114	114	4.22commerce by the manufacturer or repackager that is intended by the manufacturer or
115	115	4.23repackager for individual sale to a dispenser.
116	116	4.24 (o) (n) "National drug code" means the three-segment code maintained by the federal
117	117	4.25Food and Drug Administration that includes a labeler code, a product code, and a package
118	118	4.26code for a drug product and that has been converted to an 11-digit format consisting of five
119	119	4.27digits in the first segment, four digits in the second segment, and two digits in the third
120	120	4.28segment. A three-segment code shall be considered converted to an 11-digit format when,
121	121	4.29as necessary, at least one "0" has been added to the front of each segment containing less
122	122	4.30than the specified number of digits such that each segment contains the specified number
123	123	4.31of digits.
124	124	4Sec. 4.
125	125	REVISOR EB/VJ 25-0030401/30/25 5.1 (p) (o) "Pharmacy" or "pharmacy provider" means a community/outpatient pharmacy
126	126	5.2as defined in Minnesota Rules, part 6800.0100, subpart 2, that is also licensed as a pharmacy
127	127	5.3by the Board of Pharmacy under section 151.19.
128	128	5.4 (q) (p) "Pharmacy benefit manager" or "PBM" means an entity licensed to act as a
129	129	5.5pharmacy benefit manager under section 62W.03.
130	130	5.6 (r) (q) "Pricing unit" means the smallest dispensable amount of a prescription drug
131	131	5.7product that could be dispensed or administered.
132	132	5.8 (s) (r) "Rebate" means a discount, chargeback, or other price concession that affects the
133	133	5.9price of a prescription drug product, regardless of whether conferred through regular
134	134	5.10aggregate payments, on a claim-by-claim basis at the point of sale, as part of retrospective
135	135	5.11financial reconciliations, including reconciliations that also reflect other contractual
136	136	5.12arrangements, or by any other method. "Rebate" does not mean a bona fide service fee as
137	137	5.13defined in Code of Federal Regulations, title 42, section 447.502.
138	138	5.14 (t) (s) "Reporting entity" means any manufacturer, pharmacy, pharmacy benefit manager,
139	139	5.15wholesale drug distributor, or any other entity required to submit data under this section.
140	140	5.16 (u) (t) "Wholesale drug distributor" or "wholesaler" means an entity that:
141	141	5.17 (1) is licensed to act as a wholesale drug distributor under section 151.47; and.
142	142	5.18 (2) distributes prescription drugs, for which it is not the manufacturer, to persons or
143	143	5.19entities, or both, other than a consumer or patient in the state.
144	144	5.20 Sec. 5. Minnesota Statutes 2024, section 62J.84, subdivision 3, is amended to read:
145	145	5.21 Subd. 3.Prescription drug price increases reporting.(a) Beginning January 1, 2022,
146	146	5.22a drug manufacturer must submit to the commissioner the information described in paragraph
147	147	5.23(b) for each prescription drug for which the price was $100 or greater for a 30-day supply
148	148	5.24or for a course of treatment lasting less than 30 days and:
149	149	5.25 (1) for brand name drugs where there is an increase of ten percent or greater in the price
150	150	5.26over the previous 12-month period or an increase of 16 percent or greater in the price over
151	151	5.27the previous 24-month period; and.
152	152	5.28 (2) for generic or biosimilar drugs where there is an increase of 50 percent or greater in
153	153	5.29the price over the previous 12-month period.
154	154	5.30 (b) For each of the drugs described in paragraph (a), the manufacturer shall submit to
155	155	5.31the commissioner no later than 60 days after the price increase goes into effect, in the form
156	156	5.32and manner prescribed by the commissioner, the following information, if applicable:
157	157	5Sec. 5.
158	158	REVISOR EB/VJ 25-0030401/30/25 6.1 (1) the description and price of the drug and the net increase, expressed as a percentage,
159	159	6.2with the following listed separately:
160	160	6.3 (i) the national drug code;
161	161	6.4 (ii) the product name;
162	162	6.5 (iii) the dosage form;
163	163	6.6 (iv) the strength; and
164	164	6.7 (v) the package size;
165	165	6.8 (2) the factors that contributed to the price increase;
166	166	6.9 (3) the name of any generic version of the prescription drug available on the market;
167	167	6.10 (4) the year the prescription drug was introduced for sale in the United States;
168	168	6.11 (4) (5) the introductory price of the prescription drug when it was introduced for sale in
169	169	6.12the United States and the price of the drug on the last day of each of the five calendar years
170	170	6.13preceding the price increase;
171	171	6.14 (5) (6) the direct costs incurred during the previous 12-month period by the manufacturer
172	172	6.15that are associated with the prescription drug, listed separately:
173	173	6.16 (i) to manufacture the prescription drug;
174	174	6.17 (ii) to market the prescription drug, including advertising costs; and
175	175	6.18 (iii) to distribute the prescription drug;
176	176	6.19 (7) the number of units of the prescription drug sold during the previous 12-month period;
177	177	6.20 (6) (8) the total sales revenue for the prescription drug during the previous 12-month
178	178	6.21period;
179	179	6.22 (9) the total rebate payable amount accrued for the prescription drug during the previous
180	180	6.2312-month period;
181	181	6.24 (7) (10) the manufacturer's net profit attributable to the prescription drug during the
182	182	6.25previous 12-month period;
183	183	6.26 (8) (11) the total amount of financial assistance the manufacturer has provided through
184	184	6.27patient prescription assistance programs during the previous 12-month period, if applicable;
185	185	6.28 (9) (12) any agreement between a manufacturer and another entity contingent upon any
186	186	6.29delay in offering to market a generic version of the prescription drug;
187	187	6Sec. 5.
188	188	REVISOR EB/VJ 25-0030401/30/25 7.1 (10) (13) the patent expiration date of the prescription drug if it is under patent;
189	189	7.2 (11) (14) the name and location of the company that manufactured the drug;
190	190	7.3 (12) (15) if a brand name prescription drug, the highest price paid for the prescription
191	191	7.4drug during the previous calendar year in the ten countries, excluding the United States,
192	192	7.5that charged the highest single price for the prescription drug; and
193	193	7.6 (13) (16) if the prescription drug was acquired by the manufacturer during the previous
194	194	7.712-month period, all of the following information:
195	195	7.8 (i) price at acquisition;
196	196	7.9 (ii) price in the calendar year prior to acquisition;
197	197	7.10 (iii) name of the company from which the drug was acquired;
198	198	7.11 (iv) date of acquisition; and
199	199	7.12 (v) acquisition price.
200	200	7.13 (c) The manufacturer may submit any documentation necessary to support the information
201	201	7.14reported under this subdivision.
202	202	7.15 Sec. 6. Minnesota Statutes 2024, section 62J.84, subdivision 6, is amended to read:
203	203	7.16 Subd. 6.Public posting of prescription drug price information.(a) The commissioner
204	204	7.17shall post on the department's website, or may contract with a private entity or consortium
205	205	7.18that satisfies the standards of section 62U.04, subdivision 6, to meet this requirement, the
206	206	7.19following information:
207	207	7.20 (1) a list of the prescription drugs reported under subdivisions 3, 4, and 11 to 14 and the
208	208	7.21manufacturers of those prescription drugs; and
209	209	7.22 (2) a list of reporting entities that reported prescription drug price information under
210	210	7.23subdivisions 3, 4, and 11 to 14; and
211	211	7.24 (2) (3) information reported to the commissioner under subdivisions 3, 4, and 11 to 14,
212	212	7.25aggregated on a per-drug basis in a manner that does not allow the identification of a reporting
213	213	7.26entity that is not the manufacturer of the drug.
214	214	7.27 (b) The information must be published in an easy-to-read format and in a manner that
215	215	7.28identifies the information that is disclosed on a per-drug basis and must not be aggregated
216	216	7.29in a manner that prevents the identification of the prescription drug.
217	217	7Sec. 6.
218	218	REVISOR EB/VJ 25-0030401/30/25 8.1 (c) The commissioner shall not post to the department's website or a private entity
219	219	8.2contracting with the commissioner shall not post any information described in this section
220	220	8.3if the information is not public data under section 13.02, subdivision 8a; or is trade secret
221	221	8.4information under section 13.37, subdivision 1, paragraph (b); or is trade secret information
222	222	8.5pursuant to the Defend Trade Secrets Act of 2016, United States Code, title 18, section
223	223	8.61836, as amended. If a reporting entity believes information should be withheld from public
224	224	8.7disclosure pursuant to this paragraph, the reporting entity must clearly and specifically
225	225	8.8identify that information and describe the legal basis in writing when the reporting entity
226	226	8.9submits the information under this section. If the commissioner disagrees with the reporting
227	227	8.10entity's request to withhold information from public disclosure, the commissioner shall
228	228	8.11provide the reporting entity written notice that the information will be publicly posted 30
229	229	8.12days after the date of the notice.
230	230	8.13 (d) If the commissioner withholds any information from public disclosure pursuant to
231	231	8.14this subdivision, the commissioner shall post to the department's website a report describing
232	232	8.15the nature of the information and the commissioner's basis for withholding the information
233	233	8.16from disclosure.
234	234	8.17 (e) To the extent the information required to be posted under this subdivision is collected
235	235	8.18and made available to the public by another state, by the University of Minnesota, or through
236	236	8.19an online drug pricing reference and analytical tool, the commissioner may reference the
237	237	8.20availability of this drug price data from another source including, within existing
238	238	8.21appropriations, creating the ability of the public to access the data from the source for
239	239	8.22purposes of meeting the reporting requirements of this subdivision.
240	240	8.23 Sec. 7. Minnesota Statutes 2024, section 62J.84, subdivision 10, is amended to read:
241	241	8.24 Subd. 10.Notice of prescription drugs of substantial public interest.(a) No later than
242	242	8.25January 31, 2024, and quarterly thereafter, the commissioner shall produce and post on the
243	243	8.26department's website a list of prescription drugs that the commissioner determines to represent
244	244	8.27a substantial public interest and for which the commissioner intends to request data under
245	245	8.28subdivisions 11 to 14, subject to paragraph (c). The commissioner shall base its inclusion
246	246	8.29of prescription drugs on any information the commissioner determines is relevant to providing
247	247	8.30greater consumer awareness of the factors contributing to the cost of prescription drugs in
248	248	8.31the state, and the commissioner shall consider drug product families that include prescription
249	249	8.32drugs:
250	250	8.33 (1) that triggered reporting under subdivision 3 or 4 during the previous calendar quarter;
251	251	8Sec. 7.
252	252	REVISOR EB/VJ 25-0030401/30/25 9.1 (2) for which average claims paid amounts exceeded 125 percent of the price as of the
253	253	9.2claim incurred date during the most recent calendar quarter for which claims paid amounts
254	254	9.3are available; or
255	255	9.4 (3) that are identified by members of the public during a public comment process.
256	256	9.5 (b) Not sooner than 30 days after publicly posting the list of prescription drugs under
257	257	9.6paragraph (a), the department shall notify, via email, reporting entities registered with the
258	258	9.7department of:
259	259	9.8 (1) the requirement to report under subdivisions 11 to 14.; and
260	260	9.9 (2) the reporting period for which data must be provided.
261	261	9.10 (c) The commissioner must not designate more than 500 prescription drugs as having a
262	262	9.11substantial public interest in any one notice.
263	263	9.12 (d) Notwithstanding subdivision 16, the commissioner is exempt from chapter 14,
264	264	9.13including section 14.386, in implementing this subdivision.
265	265	9.14 EFFECTIVE DATE.This section is effective the day following final enactment.
266	266	9.15 Sec. 8. Minnesota Statutes 2024, section 62J.84, subdivision 11, is amended to read:
267	267	9.16 Subd. 11.Manufacturer prescription drug substantial public interest reporting.(a)
268	268	9.17Beginning January 1, 2024, a manufacturer must submit to the commissioner the information
269	269	9.18described in paragraph (b) for any prescription drug:
270	270	9.19 (1) included in a notification to report issued to the manufacturer by the department
271	271	9.20under subdivision 10;
272	272	9.21 (2) which the manufacturer manufactures or repackages;
273	273	9.22 (3) for which the manufacturer sets the wholesale acquisition cost; and
274	274	9.23 (4) for which the manufacturer has not submitted data under subdivision 3 during the
275	275	9.24120-day period prior to the date of the notification to report.
276	276	9.25 (b) For each of the drugs described in paragraph (a), the manufacturer shall submit to
277	277	9.26the commissioner no later than 60 days after the date of the notification to report, in the
278	278	9.27form and manner prescribed by the commissioner, the following information, if applicable:
279	279	9.28 (1) a description of the drug with the following listed separately:
280	280	9.29 (i) the national drug code;
281	281	9.30 (ii) the product name;
282	282	9Sec. 8.
283	283	REVISOR EB/VJ 25-0030401/30/25 10.1 (iii) the dosage form;
284	284	10.2 (iv) the strength; and
285	285	10.3 (v) the package size;
286	286	10.4 (2) the price of the drug product on the later of:
287	287	10.5 (i) the day one year prior to the date of the notification to report;
288	288	10.6 (ii) the introduced to market date; or
289	289	10.7 (iii) the acquisition date;
290	290	10.8 (3) the price of the drug product on the date of the notification to report;
291	291	10.9 (4) the year the prescription drug was introduced for sale in the United States;
292	292	10.10 (4) (5) the introductory price of the prescription drug when it was introduced for sale in
293	293	10.11the United States and the price of the drug on the last day of each of the five calendar years
294	294	10.12preceding the date of the notification to report;
295	295	10.13 (5) (6) the direct costs incurred during the 12-month period prior to the date of reporting
296	296	10.14period specified in the notification to report by the manufacturers that are associated with
297	297	10.15the prescription drug, listed separately:
298	298	10.16 (i) to manufacture the prescription drug;
299	299	10.17 (ii) to market the prescription drug, including advertising costs; and
300	300	10.18 (iii) to distribute the prescription drug;
301	301	10.19 (6) (7) the number of units of the prescription drug sold during the 12-month period
302	302	10.20prior to the date of reporting period specified in the notification to report;
303	303	10.21 (7) (8) the total sales revenue for the prescription drug during the 12-month period prior
304	304	10.22to the date of reporting period specified in the notification to report;
305	305	10.23 (8) (9) the total rebate payable amount accrued for the prescription drug during the
306	306	10.2412-month period prior to the date of reporting period specified in the notification to report;
307	307	10.25 (9) (10) the manufacturer's net profit attributable to the prescription drug during the
308	308	10.2612-month period prior to the date of reporting period specified in the notification to report;
309	309	10.27 (10) (11) the total amount of financial assistance the manufacturer has provided through
310	310	10.28patient prescription assistance programs during the 12-month period prior to the date of
311	311	10.29reporting period specified in the notification to report, if applicable;
312	312	10Sec. 8.
313	313	REVISOR EB/VJ 25-0030401/30/25 11.1 (11) (12) any agreement between a manufacturer and another entity contingent upon
314	314	11.2any delay in offering to market a generic version of the prescription drug;
315	315	11.3 (12) (13) the patent expiration date of the prescription drug if the prescription drug is
316	316	11.4under patent;
317	317	11.5 (13) (14) the name and location of the company that manufactured the drug;
318	318	11.6 (14) (15) if the prescription drug is a brand name prescription drug, the ten countries
319	319	11.7other than the United States that paid the highest prices for the prescription drug during the
320	320	11.8previous calendar year and their prices; and
321	321	11.9 (15) (16) if the prescription drug was acquired by the manufacturer within a 12-month
322	322	11.10period prior to the date of the reporting period specified in the notification to report, all of
323	323	11.11the following information:
324	324	11.12 (i) the price at acquisition;
325	325	11.13 (ii) the price in the calendar year prior to acquisition;
326	326	11.14 (iii) the name of the company from which the drug was acquired;
327	327	11.15 (iv) the date of acquisition; and
328	328	11.16 (v) the acquisition price.
329	329	11.17 (c) The manufacturer may submit any documentation necessary to support the information
330	330	11.18reported under this subdivision.
331	331	11.19Sec. 9. Minnesota Statutes 2024, section 62J.84, subdivision 12, is amended to read:
332	332	11.20 Subd. 12.Pharmacy prescription drug substantial public interest reporting.(a)
333	333	11.21Beginning January 1, 2024, a pharmacy must submit to the commissioner the information
334	334	11.22described in paragraph (b) for any prescription drug:
335	335	11.23 (1) included in a notification to report issued to the pharmacy by the department under
336	336	11.24subdivision 10.; and
337	337	11.25 (2) that the pharmacy dispensed in Minnesota or mailed to a Minnesota address.
338	338	11.26 (b) For each of the drugs described in paragraph (a), the pharmacy shall submit to the
339	339	11.27commissioner no later than 60 days after the date of the notification to report, in the form
340	340	11.28and manner prescribed by the commissioner, the following information, if applicable:
341	341	11.29 (1) a description of the drug with the following listed separately:
342	342	11.30 (i) the national drug code;
343	343	11Sec. 9.
344	344	REVISOR EB/VJ 25-0030401/30/25 12.1 (ii) the product name;
345	345	12.2 (iii) the dosage form;
346	346	12.3 (iv) the strength; and
347	347	12.4 (v) the package size;
348	348	12.5 (2) the number of units of the drug acquired during the 12-month period prior to the date
349	349	12.6of reporting period specified in the notification to report;
350	350	12.7 (3) the total spent before rebates by the pharmacy to acquire the drug during the 12-month
351	351	12.8period prior to the date of reporting period specified in the notification to report;
352	352	12.9 (4) the total rebate receivable amount accrued by the pharmacy for the drug during the
353	353	12.1012-month period prior to the date of reporting period specified in the notification to report;
354	354	12.11 (5) the number of pricing units of the drug dispensed by the pharmacy during the
355	355	12.1212-month period prior to the date of reporting period specified in the notification to report;
356	356	12.13 (6) the total payment receivable by the pharmacy for dispensing the drug including
357	357	12.14ingredient cost, dispensing fee, and administrative fees during the 12-month period prior
358	358	12.15to the date of reporting period specified in the notification to report;
359	359	12.16 (7) the total rebate payable amount accrued by the pharmacy for the drug during the
360	360	12.1712-month period prior to the date of reporting period specified in the notification to report;
361	361	12.18and
362	362	12.19 (8) the average cash price paid by consumers per pricing unit for prescriptions dispensed
363	363	12.20where no claim was submitted to a health care service plan or health insurer during the
364	364	12.2112-month period prior to the date of reporting period specified in the notification to report.
365	365	12.22 (c) The pharmacy may submit any documentation necessary to support the information
366	366	12.23reported under this subdivision.
367	367	12.24 (d) The commissioner may grant extensions, exemptions, or both to compliance with
368	368	12.25the requirements of paragraphs (a) and (b) by small or independent pharmacies, if compliance
369	369	12.26with paragraphs (a) and (b) would represent a hardship or undue burden to the pharmacy.
370	370	12.27The commissioner may establish procedures for small or independent pharmacies to request
371	371	12.28extensions or exemptions under this paragraph.
372	372	12Sec. 9.
373	373	REVISOR EB/VJ 25-0030401/30/25 13.1 Sec. 10. Minnesota Statutes 2024, section 62J.84, subdivision 13, is amended to read:
374	374	13.2 Subd. 13.PBM prescription drug substantial public interest reporting.(a) Beginning
375	375	13.3January 1, 2024, a PBM must submit to the commissioner the information described in
376	376	13.4paragraph (b) for any prescription drug:
377	377	13.5 (1) included in a notification to report issued to the PBM by the department under
378	378	13.6subdivision 10.; and
379	379	13.7 (2) for which the PBM fulfilled pharmacy benefit management duties for Minnesota
380	380	13.8residents.
381	381	13.9 (b) For each of the drugs described in paragraph (a), the PBM shall submit to the
382	382	13.10commissioner no later than 60 days after the date of the notification to report, in the form
383	383	13.11and manner prescribed by the commissioner, the following information, if applicable:
384	384	13.12 (1) a description of the drug with the following listed separately:
385	385	13.13 (i) the national drug code;
386	386	13.14 (ii) the product name;
387	387	13.15 (iii) the dosage form;
388	388	13.16 (iv) the strength; and
389	389	13.17 (v) the package size;
390	390	13.18 (2) the number of pricing units of the drug product filled for which the PBM administered
391	391	13.19claims during the 12-month period prior to the date of reporting period specified in the
392	392	13.20notification to report;
393	393	13.21 (3) the total reimbursement amount accrued and payable to pharmacies for pricing units
394	394	13.22of the drug product filled for which the PBM administered claims during the 12-month
395	395	13.23period prior to the date of reporting period specified in the notification to report;
396	396	13.24 (4) the total reimbursement or administrative fee amount, or both, accrued and receivable
397	397	13.25from payers for pricing units of the drug product filled for which the PBM administered
398	398	13.26claims during the 12-month period prior to the date of reporting period specified in the
399	399	13.27notification to report;
400	400	13.28 (5) the total administrative fee amount accrued and receivable from payers for pricing
401	401	13.29units of the drug product filled during the reporting period specified in the notification to
402	402	13.30report;
403	403	13Sec. 10.
404	404	REVISOR EB/VJ 25-0030401/30/25 14.1 (5) (6) the total rebate receivable amount accrued by the PBM for the drug product
405	405	14.2during the 12-month period prior to the date of reporting period specified in the notification
406	406	14.3to report; and
407	407	14.4 (6) (7) the total rebate payable amount accrued by the PBM for the drug product during
408	408	14.5the 12-month period prior to the date of reporting period specified in the notification to
409	409	14.6report.
410	410	14.7 (c) The PBM may submit any documentation necessary to support the information
411	411	14.8reported under this subdivision.
412	412	14.9 Sec. 11. Minnesota Statutes 2024, section 62J.84, subdivision 14, is amended to read:
413	413	14.10 Subd. 14.Wholesale drug distributor prescription drug substantial public interest
414	414	14.11reporting.(a) Beginning January 1, 2024, a wholesale drug distributor that distributes
415	415	14.12prescription drugs, for which it is not the manufacturer, to persons or entities, or both, other
416	416	14.13than a consumer or patient in the state, must submit to the commissioner the information
417	417	14.14described in paragraph (b) for any prescription drug:
418	418	14.15 (1) included in a notification to report issued to the wholesale drug distributor by the
419	419	14.16department under subdivision 10.; and
420	420	14.17 (2) that the wholesale drug distributor distributed within or into Minnesota.
421	421	14.18 (b) For each of the drugs described in paragraph (a), the wholesale drug distributor shall
422	422	14.19submit to the commissioner no later than 60 days after the date of the notification to report,
423	423	14.20in the form and manner prescribed by the commissioner, the following information, if
424	424	14.21applicable:
425	425	14.22 (1) a description of the drug with the following listed separately:
426	426	14.23 (i) the national drug code;
427	427	14.24 (ii) the product name;
428	428	14.25 (iii) the dosage form;
429	429	14.26 (iv) the strength; and
430	430	14.27 (v) the package size;
431	431	14.28 (2) the number of units of the drug product acquired by the wholesale drug distributor
432	432	14.29during the 12-month period prior to the date of reporting period specified in the notification
433	433	14.30to report;
434	434	14Sec. 11.
435	435	REVISOR EB/VJ 25-0030401/30/25 15.1 (3) the total spent before rebates by the wholesale drug distributor to acquire the drug
436	436	15.2product during the 12-month period prior to the date of reporting period specified in the
437	437	15.3notification to report;
438	438	15.4 (4) the total rebate receivable amount accrued by the wholesale drug distributor for the
439	439	15.5drug product during the 12-month period prior to the date of reporting period specified in
440	440	15.6the notification to report;
441	441	15.7 (5) the number of units of the drug product sold by the wholesale drug distributor during
442	442	15.8the 12-month period prior to the date of reporting period specified in the notification to
443	443	15.9report;
444	444	15.10 (6) gross revenue from sales in the United States generated by the wholesale drug
445	445	15.11distributor for this the drug product during the 12-month period prior to the date of reporting
446	446	15.12period specified in the notification to report; and
447	447	15.13 (7) total rebate payable amount accrued by the wholesale drug distributor for the drug
448	448	15.14product during the 12-month period prior to the date of reporting period specified in the
449	449	15.15notification to report.
450	450	15.16 (c) The wholesale drug distributor may submit any documentation necessary to support
451	451	15.17the information reported under this subdivision.
452	452	15.18Sec. 12. Minnesota Statutes 2024, section 62J.84, subdivision 15, is amended to read:
453	453	15.19 Subd. 15.Registration requirements.Beginning Effective January 1, 2024 2026, a
454	454	15.20reporting entity subject to this chapter shall register, or update existing registration
455	455	15.21information, with the department in a form and manner prescribed by the commissioner by
456	456	15.22January 30 of each year.
457	457	15Sec. 12.
458	458	REVISOR EB/VJ 25-0030401/30/25