Minnesota 2023-2024 Regular Session

Minnesota Senate Bill SF168 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1		1.1 A bill for an act
2	2		1.2 relating to health; prohibiting excessive price increases by manufacturers to generic
3	3		1.3 or off-patent drugs; authorizing the attorney general to take action against
4	4		1.4 manufacturers for certain price increases; prohibiting withdrawal of certain generic
5	5		1.5 or off-patent drugs sales; establishing a prescription drug affordability board and
6	6		1.6 prescription drug affordability advisory council; providing for prescription drug
7	7		1.7 cost reviews and remedies; providing appointments; imposing civil penalties;
8	8		1.8 requiring a report; appropriating money; amending Minnesota Statutes 2022,
9	9		1.9 section 151.071, subdivisions 1, 2; proposing coding for new law in Minnesota
10	10		1.10 Statutes, chapter 62J.
11	11		1.11BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
12	12		1.12 Section 1. [62J.841] DEFINITIONS.
13	13		1.13 Subdivision 1.Scope.For purposes of sections 62J.841 to 62J.845, the following
14	14		1.14definitions apply.
15	15		1.15 Subd. 2.Consumer Price Index."Consumer Price Index" means the Consumer Price
16	16		1.16Index, Annual Average, for All Urban Consumers, CPI-U: U.S. City Average, All Items,
17	17		1.17reported by the United States Department of Labor, Bureau of Labor Statistics, or its
18	18		1.18successor or, if the index is discontinued, an equivalent index reported by a federal authority
19	19		1.19or, if no such index is reported, "Consumer Price Index" means a comparable index chosen
20	20		1.20by the Bureau of Labor Statistics.
21	21		1.21 Subd. 3.Generic or off-patent drug."Generic or off-patent drug" means any prescription
22	22		1.22drug for which any exclusive marketing rights granted under the Federal Food, Drug, and
23	23		1.23Cosmetic Act, section 351 of the federal Public Health Service Act, and federal patent law
24	24		1.24have expired, including any drug-device combination product for the delivery of a generic
25	25		1.25drug.
26	26		1Section 1.
27		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~
	27	+	S0168-1 1st EngrossmentSF168 REVISOR AGW
28	28		SENATE
29	29		STATE OF MINNESOTA
30	30		S.F. No. 168NINETY-THIRD SESSION
31	31		(SENATE AUTHORS: MORRISON, Mann, Boldon, Fateh and Hoffman)
32	32		OFFICIAL STATUSD-PGDATE
33	33		Introduction and first reading14201/11/2023
34	34		Referred to Health and Human Services
35	35		Author added Boldon30901/19/2023
36	36		Withdrawn and re-referred to Commerce and Consumer Protection38301/25/2023
37	37		Author added Fateh46801/27/2023
38	38		Author added Hoffman68502/06/2023
39		-	Comm report: To pass as amended and re-refer to Judiciary and Public Safety1037a02/27/2023
40		-	Withdrawn and re-referred to Health and Human Services180003/15/2023
41		-	Comm report: To pass and re-referred to State and Local Government and Veterans198903/20/2023
42		-	Comm report: To pass as amended and re-refer to Judiciary and Public Safety03/27/2023 2.1 Subd. 4.Manufacturer."Manufacturer" has the meaning provided in section 151.01,
	39	+	Comm report: To pass as amended and re-refer to Judiciary and Public Safety02/27/2023 2.1 Subd. 4.Manufacturer."Manufacturer" has the meaning provided in section 151.01,
43	40		2.2subdivision 14a, but does not include an entity required solely because the entity repackages
44	41		2.3or relabels drugs.
45	42		2.4 Subd. 5.Prescription drug."Prescription drug" means a drug for human use subject
46	43		2.5to United States Code, title 21, section 353(b)(1).
47	44		2.6 Subd. 6.Wholesale acquisition cost."Wholesale acquisition cost" has the meaning
48	45		2.7provided in United States Code, title 42, section 1395w-3a.
49	46		2.8 Subd. 7.Wholesale distributor."Wholesale distributor" has the meaning provided in
50	47		2.9section 151.441, subdivision 14.
51	48		2.10 Sec. 2. [62J.842] EXCESSIVE PRICE INCREASES PROHIBITED.
52	49		2.11 Subdivision 1.Prohibition.No manufacturer shall impose, or cause to be imposed, an
53	50		2.12excessive price increase, whether directly or through a wholesale distributor, pharmacy, or
54	51		2.13similar intermediary, on the sale of any generic or off-patent drug sold, dispensed, or
55	52		2.14delivered to any consumer in the state.
56	53		2.15 Subd. 2.Excessive price increase.A price increase is excessive for purposes of this
57	54		2.16section when:
58	55		2.17 (1) the price increase, adjusted for inflation utilizing the Consumer Price Index, exceeds:
59	56		2.18 (i) 15 percent of the wholesale acquisition cost over the immediately preceding calendar
60	57		2.19year; or
61	58		2.20 (ii) 40 percent of the wholesale acquisition cost over the immediately preceding three
62	59		2.21calendar years; and
63	60		2.22 (2) the price increase, adjusted for inflation utilizing the Consumer Price Index, exceeds
64	61		2.23$30 for:
65	62		2.24 (i) a 30-day supply of the drug; or
66	63		2.25 (ii) a course of treatment lasting less than 30 days.
67	64		2.26 Subd. 3.Exemption.It is not a violation of this section for a wholesale distributor or
68	65		2.27pharmacy to increase the price of a generic or off-patent drug if the price increase is directly
69	66		2.28attributable to additional costs for the drug imposed on the wholesale distributor or pharmacy
70	67		2.29by the manufacturer of the drug.
71	68		2Sec. 2.
72		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 3.1 Sec. 3. [62J.843] REGISTERED AGENT AND OFFICE WITHIN THE STATE.
	69	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 3.1 Sec. 3. [62J.843] REGISTERED AGENT AND OFFICE WITHIN THE STATE.
73	70		3.2 Any manufacturer that sells, distributes, delivers, or offers for sale any generic or
74	71		3.3off-patent drug in the state must maintain a registered agent and office within the state.
75	72		3.4 Sec. 4. [62J.844] ENFORCEMENT .
76	73		3.5 Subdivision 1.Notification.(a) The commissioner of health shall notify the manufacturer
77	74		3.6of a generic or off-patent drug, the attorney general, and the Board of Pharmacy of any price
78	75		3.7increase that the commissioner believes may violate section 62J.842.
79	76		3.8 (b) The commissioner of management and budget and any other state agency that provides
80	77		3.9or purchases a pharmacy benefit except the Department of Human Services, and any entity
81	78		3.10under contract with a state agency to provide a pharmacy benefit other than an entity under
82	79		3.11contract with the Department of Human Services, may notify the manufacturer of a generic
83	80		3.12or off-patent drug, the attorney general, and the Board of Pharmacy of any price increase
84	81		3.13that the commissioner or entity believes may violate section 62J.842.
85	82		3.14 Subd. 2.Submission of drug cost statement and other information by manufacturer;
86	83		3.15investigation by attorney general.(a) Within 45 days of receiving a notice under subdivision
87	84		3.161, the manufacturer of the generic or off-patent drug shall submit a drug cost statement to
88	85		3.17the attorney general. The statement must:
89	86		3.18 (1) itemize the cost components related to production of the drug;
90	87		3.19 (2) identify the circumstances and timing of any increase in materials or manufacturing
91	88		3.20costs that caused any increase during the preceding calendar year, or preceding three calendar
92	89		3.21years as applicable, in the price of the drug; and
93	90		3.22 (3) provide any other information that the manufacturer believes to be relevant to a
94	91		3.23determination of whether a violation of section 62J.842 has occurred.
95	92		3.24 (b) The attorney general may investigate whether a violation of section 62J.842 has
96	93		3.25occurred, in accordance with section 8.31, subdivision 2.
97	94		3.26 Subd. 3.Petition to court.(a) On petition of the attorney general, a court may issue an
98	95		3.27order:
99	96		3.28 (1) compelling the manufacturer of a generic or off-patent drug to:
100	97		3.29 (i) provide the drug cost statement required under subdivision 2, paragraph (a); and
101	98		3.30 (ii) answer interrogatories, produce records or documents, or be examined under oath,
102	99		3.31as required by the attorney general under subdivision 2, paragraph (b);
103	100		3Sec. 4.
104		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 4.1 (2) restraining or enjoining a violation of sections 62J.841 to 62J.845, including issuing
	101	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 4.1 (2) restraining or enjoining a violation of sections 62J.841 to 62J.845, including issuing
105	102		4.2an order requiring that drug prices be restored to levels that comply with section 62J.842;
106	103		4.3 (3) requiring the manufacturer to provide an accounting to the attorney general of all
107	104		4.4revenues resulting from a violation of section 62J.842;
108	105		4.5 (4) requiring the manufacturer to repay to all Minnesota consumers, including any
109	106		4.6third-party payers, any money acquired as a result of a price increase that violates section
110	107		4.762J.842;
111	108		4.8 (5) notwithstanding section 16A.151, requiring that all revenues generated from a
112	109		4.9violation of section 62J.842 be remitted to the state and deposited into a special fund, to be
113	110		4.10used for initiatives to reduce the cost to consumers of acquiring prescription drugs, if a
114	111		4.11manufacturer is unable to determine the individual transactions necessary to provide the
115	112		4.12repayments described in clause (4);
116	113		4.13 (6) imposing a civil penalty of up to $10,000 per day for each violation of section 62J.842;
117	114		4.14 (7) providing for the attorney general's recovery of costs and disbursements incurred in
118	115		4.15bringing an action against a manufacturer found in violation of section 62J.842, including
119	116		4.16the costs of investigation and reasonable attorney's fees; and
120	117		4.17 (8) providing any other appropriate relief, including any other equitable relief as
121	118		4.18determined by the court.
122	119		4.19 (b) For purposes of paragraph (a), clause (6), every individual transaction in violation
123	120		4.20of section 62J.842 is considered a separate violation.
124	121		4.21 Subd. 4.Private right of action.Any action brought pursuant to section 8.31, subdivision
125	122		4.223a, by a person injured by a violation of section 62J.842 is for the benefit of the public.
126	123		4.23 Sec. 5. [62J.845] PROHIBITION ON WITHDRAWAL OF GENERIC OR
127	124		4.24OFF-PATENT DRUGS FOR SALE.
128	125		4.25 Subdivision 1.Prohibition.A manufacturer of a generic or off-patent drug is prohibited
129	126		4.26from withdrawing that drug from sale or distribution within this state for the purpose of
130	127		4.27avoiding the prohibition on excessive price increases under section 62J.842.
131	128		4.28 Subd. 2.Notice to board and attorney general.Any manufacturer that intends to
132	129		4.29withdraw a generic or off-patent drug from sale or distribution within the state shall provide
133	130		4.30a written notice of withdrawal to the Board of Pharmacy and the attorney general, at least
134	131		4.3190 days prior to the withdrawal.
135	132		4Sec. 5.
136		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 5.1 Subd. 3.Financial penalty.The attorney general shall assess a penalty of $500,000 on
	133	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 5.1 Subd. 3.Financial penalty.The attorney general shall assess a penalty of $500,000 on
137	134		5.2any manufacturer of a generic or off-patent drug that the attorney general determines has
138	135		5.3failed to comply with the requirements of this section.
139	136		5.4 Sec. 6. [62J.846] SEVERABILITY.
140	137		5.5 If any provision of sections 62J.841 to 62J.845 or the application thereof to any person
141	138		5.6or circumstance is held invalid for any reason in a court of competent jurisdiction, the
142	139		5.7invalidity does not affect other provisions or any other application of sections 62J.841 to
143	140		5.862J.845 that can be given effect without the invalid provision or application.
144	141		5.9 Sec. 7. [62J.85] CITATION.
145	142		5.10 Sections 62J.85 to 62J.95 may be cited as the "Prescription Drug Affordability Act."
146	143		5.11 Sec. 8. [62J.86] DEFINITIONS.
147	144		5.12 Subdivision 1.Definitions.For the purposes of sections 62J.85 to 62J.95, the following
148	145		5.13terms have the meanings given them.
149	146		5.14 Subd. 2.Advisory council."Advisory council" means the Prescription Drug Affordability
150	147		5.15Advisory Council established under section 62J.88.
151	148		5.16 Subd. 3.Biologic."Biologic" means a drug that is produced or distributed in accordance
152	149		5.17with a biologics license application approved under Code of Federal Regulations, title 42,
153	150		5.18section 447.502.
154	151		5.19 Subd. 4.Biosimilar."Biosimilar" has the meaning provided in section 62J.84, subdivision
155	152		5.202, paragraph (b).
156	153		5.21 Subd. 5.Board."Board" means the Prescription Drug Affordability Board established
157	154		5.22under section 62J.87.
158	155		5.23 Subd. 6.Brand name drug."Brand name drug" means a drug that is produced or
159	156		5.24distributed pursuant to:
160	157		5.25 (1) a new drug application approved under United States Code, title 21, section 355(c),
161	158		5.26except for a generic drug as defined under Code of Federal Regulations, title 42, section
162	159		5.27447.502; or
163	160		5.28 (2) a biologics license application approved under United States Code, title 45, section
164	161		5.29262(a)(c).
165	162		5Sec. 8.
166		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 6.1 Subd. 7.Generic drug."Generic drug" has the meaning provided in section 62J.84,
	163	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 6.1 Subd. 7.Generic drug."Generic drug" has the meaning provided in section 62J.84,
167	164		6.2subdivision 2, paragraph (e).
168	165		6.3 Subd. 8.Group purchaser."Group purchaser" has the meaning given in section 62J.03,
169	166		6.4subdivision 6, and includes pharmacy benefit managers as defined in section 62W.02,
170	167		6.5subdivision 15.
171	168		6.6 Subd. 9.Manufacturer."Manufacturer" means an entity that:
172	169		6.7 (1) engages in the manufacture of a prescription drug product or enters into a lease with
173	170		6.8another manufacturer to market and distribute a prescription drug product under the entity's
174	171		6.9own name; and
175	172		6.10 (2) sets or changes the wholesale acquisition cost of the prescription drug product it
176	173		6.11manufacturers or markets.
177	174		6.12 Subd. 10.Prescription drug product."Prescription drug product" means a brand name
178	175		6.13drug, a generic drug, a biologic, or a biosimilar.
179	176		6.14 Subd. 11.Wholesale acquisition cost or WAC."Wholesale acquisition cost" or "WAC"
180	177		6.15has the meaning given in United States Code, title 42, section 1395W-3a(c)(6)(B).
181	178		6.16 Sec. 9. [62J.87] PRESCRIPTION DRUG AFFORDABILITY BOARD.
182	179		6.17 Subdivision 1.Establishment.The commissioner of commerce shall establish the
183	180		6.18Prescription Drug Affordability Board, which shall be governed as a board under section
184	181		6.1915.012, paragraph (a), to protect consumers, state and local governments, health plan
185	182		6.20companies, providers, pharmacies, and other health care system stakeholders from
186	183		6.21unaffordable costs of certain prescription drugs.
187	184		6.22 Subd. 2.Membership.(a) The Prescription Drug Affordability Board consists of eleven
188	185		6.23members appointed as follows:
189	186		6.24 (1) seven voting members appointed by the governor;
190	187		6.25 (2) one nonvoting member appointed by the majority leader of the senate;
191	188		6.26 (3) one nonvoting member appointed by the minority leader of the senate;
192	189		6.27 (4) one nonvoting member appointed by the speaker of the house; and
193	190		6.28 (5) one nonvoting member appointed by the minority leader of the house of
194	191		6.29representatives.
195	192		6.30 (b) All members appointed must have knowledge and demonstrated expertise in
196	193		6.31pharmaceutical economics and finance or health care economics and finance. A member
197	194		6Sec. 9.
198		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 7.1must not be an employee of, a board member of, or a consultant to a manufacturer or trade
	195	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 7.1must not be an employee of, a board member of, or a consultant to a manufacturer or trade
199	196		7.2association for manufacturers or a pharmacy benefit manager or trade association for
200	197		7.3pharmacy benefit managers.
201	198		7.4 (c) Initial appointments must be made by January 1, 2024.
202	199		7.5 Subd. 3.Terms.(a) Board appointees shall serve four-year terms, except that initial
203	200		7.6appointees shall serve staggered terms of two, three, or four years as determined by lot by
204	201		7.7the secretary of state. A board member shall serve no more than two consecutive terms.
205	202		7.8 (b) A board member may resign at any time by giving written notice to the board.
206	203		7.9 Subd. 4.Chair; other officers.(a) The governor shall designate an acting chair from
207	204		7.10the members appointed by the governor.
208	205		7.11 (b) The board shall elect a chair to replace the acting chair at the first meeting of the
209	206		7.12board by a majority of the members. The chair shall serve for one year.
210	207		7.13 (c) The board shall elect a vice-chair and other officers from its membership as it deems
211	208		7.14necessary.
212	209		7.15 Subd. 5.Staff; technical assistance.(a) The board shall hire an executive director and
213	210		7.16other staff, who shall serve in the unclassified service. The executive director must have
214	211		7.17knowledge and demonstrated expertise in pharmacoeconomics, pharmacology, health policy,
215	212		7.18health services research, medicine, or a related field or discipline.
216	213		7.19 (b) The commissioner of health shall provide technical assistance to the board. The board
217	214		7.20may also employ or contract for professional and technical assistance as the board deems
218	215		7.21necessary to perform the board's duties.
219	216		7.22 (c) The attorney general shall provide legal services to the board.
220	217		7.23 Subd. 6.Compensation.The board members shall not receive compensation but may
221	218		7.24receive reimbursement for expenses as authorized under section 15.059, subdivision 3.
222	219		7.25 Subd. 7.Meetings.(a) Meetings of the board are subject to chapter 13D. The board shall
223	220		7.26meet publicly at least every three months to review prescription drug product information
224	221		7.27submitted to the board under section 62J.90. If there are no pending submissions, the chair
225	222		7.28of the board may cancel or postpone the required meeting. The board may meet in closed
226	223		7.29session when reviewing proprietary information as determined under the standards developed
227	224		7.30in accordance with section 62J.91, subdivision 3.
228	225		7Sec. 9.
229		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 8.1 (b) The board shall announce each public meeting at least three weeks prior to the
	226	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 8.1 (b) The board shall announce each public meeting at least three weeks prior to the
230	227		8.2scheduled date of the meeting. Any materials for the meeting shall be made public at least
231	228		8.3two weeks prior to the scheduled date of the meeting.
232	229		8.4 (c) At each public meeting, the board shall provide the opportunity for comments from
233	230		8.5the public, including the opportunity for written comments to be submitted to the board
234	231		8.6prior to a decision by the board.
235	232		8.7 Sec. 10. [62J.88] PRESCRIPTION DRUG AFFORDABILITY ADVISORY
236	233		8.8COUNCIL.
237		-	8.9 Subdivision 1.Establishment.The governor shall appoint ~~an 18~~-member stakeholder
	234	+	8.9 Subdivision 1.Establishment.The governor shall appoint a 17-member stakeholder
238	235		8.10advisory council to provide advice to the board on drug cost issues and to represent
239	236		8.11stakeholders' views. The governor shall appoint the members of the advisory council based
240	237		8.12on the members' knowledge and demonstrated expertise in one or more of the following
241	238		8.13areas: the pharmaceutical business; practice of medicine; patient perspectives; health care
242	239		8.14cost trends and drivers; clinical and health services research; and the health care marketplace.
243	240		8.15 Subd. 2.Membership.The council's membership shall consist of the following:
244	241		8.16 (1) two members representing patients and health care consumers;
245	242		8.17 (2) two members representing health care providers;
246	243		8.18 (3) one member representing health plan companies;
247	244		8.19 (4) two members representing employers, with one member representing large employers
248	245		8.20and one member representing small employers;
249	246		8.21 (5) one member representing government employee benefit plans;
250	247		8.22 (6) one member representing pharmaceutical manufacturers;
251	248		8.23 (7) one member who is a health services clinical researcher;
252	249		8.24 (8) one member who is a pharmacologist;
253	250		8.25 (9) one member representing the commissioner of health with expertise in health
254	251		8.26economics;
255	252		8.27 (10) one member representing pharmaceutical wholesalers;
256	253		8.28 (11) one member representing pharmacy benefit managers;
257	254		8.29 (12) one member from the Rare Disease Advisory Council;
258		-	8.30 (13) one member representing generic drug manufacturers;
	255	+	8.30 (13) one member representing generic drug manufacturers; and
259	256		8Sec. 10.
260		-	S0168-2 2nd EngrossmentSF168 REVISOR SGS 9.1 (14) one member representing pharmaceutical distributors; and
261		-	9.2 (15) one member who is an oncologist who is not employed by, under contract with, or
262		-	9.3otherwise affiliated with a hospital.
263		-	9.4 Subd. 3.Terms.(a) The initial appointments to the advisory council must be made by
264		-	9.5January 1, 2024. The initial appointed advisory council members shall serve staggered terms
265		-	9.6of two, three, or four years determined by lot by the secretary of state. Following the initial
266		-	9.7appointments, the advisory council members shall serve four-year terms.
267		-	9.8 (b) Removal and vacancies of advisory council members shall be governed by section
268		-	9.915.059.
269		-	9.10 Subd. 4.Compensation.Advisory council members may be compensated according to
270		-	9.11section 15.059.
271		-	9.12 Subd. 5.Meetings.Meetings of the advisory council are subject to chapter 13D. The
272		-	9.13advisory council shall meet publicly at least every three months to advise the board on drug
273		-	9.14cost issues related to the prescription drug product information submitted to the board under
274		-	9.15section 62J.90.
275		-	9.16 Subd. 6.Exemption.Notwithstanding section 15.059, the advisory council shall not
276		-	9.17expire.
277		-	9.18 Sec. 11. [62J.89] CONFLICTS OF INTEREST.
278		-	9.19 Subdivision 1.Definition.For purposes of this section, "conflict of interest" means a
279		-	9.20financial or personal association that has the potential to bias or have the appearance of
280		-	9.21biasing a person's decisions in matters related to the board, the advisory council, or in the
281		-	9.22conduct of the board's or council's activities. A conflict of interest includes any instance in
282		-	9.23which a person, a person's immediate family member, including a spouse, parent, child, or
283		-	9.24other legal dependent, or an in-law of any of the preceding individuals, has received or
284		-	9.25could receive a direct or indirect financial benefit of any amount deriving from the result
285		-	9.26or findings of a decision or determination of the board. For purposes of this section, a
286		-	9.27financial benefit includes honoraria, fees, stock, the value of the member's, immediate family
287		-	9.28member's, or in-law's stock holdings, and any direct financial benefit deriving from the
288		-	9.29finding of a review conducted under sections 62J.85 to 62J.95. Ownership of securities is
289		-	9.30not a conflict of interest if the securities are: (1) part of a diversified mutual or exchange
290		-	9.31traded fund; or (2) in a tax-deferred or tax-exempt retirement account that is administered
291		-	9.32by an independent trustee.
	257	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 9.1 (14) one member representing pharmaceutical distributors.
	258	+	9.2 Subd. 3.Terms.(a) The initial appointments to the advisory council must be made by
	259	+	9.3January 1, 2024. The initial appointed advisory council members shall serve staggered terms
	260	+	9.4of two, three, or four years determined by lot by the secretary of state. Following the initial
	261	+	9.5appointments, the advisory council members shall serve four-year terms.
	262	+	9.6 (b) Removal and vacancies of advisory council members shall be governed by section
	263	+	9.715.059.
	264	+	9.8 Subd. 4.Compensation.Advisory council members may be compensated according to
	265	+	9.9section 15.059.
	266	+	9.10 Subd. 5.Meetings.Meetings of the advisory council are subject to chapter 13D. The
	267	+	9.11advisory council shall meet publicly at least every three months to advise the board on drug
	268	+	9.12cost issues related to the prescription drug product information submitted to the board under
	269	+	9.13section 62J.90.
	270	+	9.14 Subd. 6.Exemption.Notwithstanding section 15.059, the advisory council shall not
	271	+	9.15expire.
	272	+	9.16 Sec. 11. [62J.89] CONFLICTS OF INTEREST.
	273	+	9.17 Subdivision 1.Definition.For purposes of this section, "conflict of interest" means a
	274	+	9.18financial or personal association that has the potential to bias or have the appearance of
	275	+	9.19biasing a person's decisions in matters related to the board, the advisory council, or in the
	276	+	9.20conduct of the board's or council's activities. A conflict of interest includes any instance in
	277	+	9.21which a person, a person's immediate family member, including a spouse, parent, child, or
	278	+	9.22other legal dependent, or an in-law of any of the preceding individuals, has received or
	279	+	9.23could receive a direct or indirect financial benefit of any amount deriving from the result
	280	+	9.24or findings of a decision or determination of the board. For purposes of this section, a
	281	+	9.25financial benefit includes honoraria, fees, stock, the value of the member's, immediate family
	282	+	9.26member's, or in-law's stock holdings, and any direct financial benefit deriving from the
	283	+	9.27finding of a review conducted under sections 62J.85 to 62J.95. Ownership of securities is
	284	+	9.28not a conflict of interest if the securities are: (1) part of a diversified mutual or exchange
	285	+	9.29traded fund; or (2) in a tax-deferred or tax-exempt retirement account that is administered
	286	+	9.30by an independent trustee.
	287	+	9.31 Subd. 2.General.(a) Prior to the acceptance of an appointment or employment, or prior
	288	+	9.32to entering into a contractual agreement, a board or advisory council member, board staff
	289	+	9.33member, or third-party contractor must disclose to the appointing authority or the board
292	290		9Sec. 11.
293		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 10.~~1 Subd~~. ~~2.General.(a) Prior to~~ the ~~acceptance of an appointment or employment~~, ~~or prior~~
294		-	10.~~2to entering into a contractual agreement, a board or advisory council member, board staff~~
295		-	10.~~3member~~, or third-party contractor ~~must disclose to the appointing authority or the board~~
296		-	10.~~4any conflicts of interest.~~ ~~The information disclosed~~ must ~~include the type, nature, and~~
297		-	10.~~5magnitude of~~ the ~~interests involved.~~
298		-	10.~~6 (b) A board member, board staff member, or third-party contractor with a conflict of~~
299		-	10.~~7interest with regard to~~ any ~~prescription drug product under review~~ must ~~recuse themselves~~
300		-	10.~~8from any discussion, review, decision,~~ or ~~determination made by~~ the ~~board relating to the~~
301		-	10.~~9prescription drug product~~.
302		-	10.~~10 (c) Any conflict~~ of ~~interest must be disclosed in advance of the first meeting after the~~
303		-	10.~~11conflict is identified~~ or ~~within five days after~~ the ~~conflict is identified,~~ ~~whichever is earlier.~~
304		-	10.~~12 Subd. 3.Prohibitions.Board members,~~ board ~~staff, or third-party contractors are~~
305		-	10.~~13prohibited from accepting gifts,~~ ~~bequeaths, or donations of services or property that raise~~
306		-	10.~~14the specter of a conflict of interest or have the appearance of injecting bias into the activities~~
307		-	10.~~15of~~ the ~~board.~~
308		-	10.~~16Sec~~. ~~12.~~ ~~[62J.90] PRESCRIPTION DRUG PRICE~~ INFORMATION~~; DECISION~~
309		-	10.17TO ~~CONDUCT COST REVIEW~~.
310		-	10.~~18 Subdivision 1.Drug price~~ information ~~from~~ the ~~commissioner~~ of ~~health and other~~
311		-	10.~~19sources~~.~~(a) The commissioner of health shall provide to the board the information reported~~
312		-	10.~~20to~~ the ~~commissioner by~~ drug ~~manufacturers under section 62J.84~~, ~~subdivisions 3, 4, and 5.~~
313		-	10.~~21The commissioner shall provide this information to~~ the board ~~within 30 days of the date the~~
314		-	10.~~22information is received from~~ drug ~~manufacturers~~.
315		-	10.~~23 (b)~~ The ~~board may subscribe to one or more~~ prescription drug ~~pricing files, such as~~
316		-	10.~~24Medispan or FirstDatabank, or as otherwise determined by~~ the ~~board.~~
317		-	10.25 ~~Subd. 2.Identification of certain prescription drug products.(a)~~ The ~~board, in~~
318		-	10.~~26consultation with the advisory council~~, ~~shall identify selected prescription drug products~~
319		-	10.~~27based on~~ the ~~following criteria:~~
320		-	10.28 (1) brand name drugs or biologics ~~for which the~~ WAC ~~increases by~~ more ~~than 15 percent~~
321		-	10.29or ~~by more than $3,000 during any 12-month period or~~ course of treatment ~~if less than 12~~
322		-	10.~~30months, after adjusting for changes in~~ the ~~consumer price index (CPI);~~
323		-	10.~~31 (2)~~ brand name ~~drugs or biologics with a WAC of $60,000 or more per calendar year~~
324		-	10.~~32or per course of treatment;~~
	291	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 10.1any conflicts of interest. The information disclosed must include the type, nature, and
	292	+	10.2magnitude of the interests involved.
	293	+	10.3 (b) A board member, board staff member, or third-party contractor with a conflict of
	294	+	10.4interest with regard to any prescription drug product under review must recuse themselves
	295	+	10.5from any discussion, review, decision, or determination made by the board relating to the
	296	+	10.6prescription drug product.
	297	+	10.7 (c) Any conflict of interest must be disclosed in advance of the first meeting after the
	298	+	10.8conflict is identified or within five days after the conflict is identified, whichever is earlier.
	299	+	10.9 Subd. 3.Prohibitions.Board members, board staff, or third-party contractors are
	300	+	10.10prohibited from accepting gifts, bequeaths, or donations of services or property that raise
	301	+	10.11the specter of a conflict of interest or have the appearance of injecting bias into the activities
	302	+	10.12of the board.
	303	+	10.13Sec. 12. [62J.90] PRESCRIPTION DRUG PRICE INFORMATION; DECISION
	304	+	10.14TO CONDUCT COST REVIEW.
	305	+	10.15 Subdivision 1.Drug price information from the commissioner of health and other
	306	+	10.16sources.(a) The commissioner of health shall provide to the board the information reported
	307	+	10.17to the commissioner by drug manufacturers under section 62J.84, subdivisions 3, 4, and 5.
	308	+	10.18The commissioner shall provide this information to the board within 30 days of the date the
	309	+	10.19information is received from drug manufacturers.
	310	+	10.20 (b) The board may subscribe to one or more prescription drug pricing files, such as
	311	+	10.21Medispan or FirstDatabank, or as otherwise determined by the board.
	312	+	10.22 Subd. 2.Identification of certain prescription drug products.(a) The board, in
	313	+	10.23consultation with the advisory council, shall identify selected prescription drug products
	314	+	10.24based on the following criteria:
	315	+	10.25 (1) brand name drugs or biologics for which the WAC increases by more than 15 percent
	316	+	10.26or by more than $3,000 during any 12-month period or course of treatment if less than 12
	317	+	10.27months, after adjusting for changes in the consumer price index (CPI);
	318	+	10.28 (2) brand name drugs or biologics with a WAC of $60,000 or more per calendar year
	319	+	10.29or per course of treatment;
	320	+	10.30 (3) biosimilar drugs that have a WAC that is not at least 20 percent lower than the
	321	+	10.31referenced brand name biologic at the time the biosimilar is introduced; and
	322	+	10.32 (4) generic drugs for which the WAC:
325	323		10Sec. 12.
326		-	S0168-2 2nd EngrossmentSF168 REVISOR SGS 11.1 (3) biosimilar drugs that have a WAC that is not at least 20 percent lower than the
327		-	11.2referenced brand name biologic at the time the biosimilar is introduced; and
328		-	11.3 (4) generic drugs for which the WAC:
329		-	11.4 (i) is $100 or more, after adjusting for changes in the CPI, for:
330		-	11.5 (A) a 30-day supply lasting a patient for 30 consecutive days based on the recommended
331		-	11.6dosage approved for labeling by the United States Food and Drug Administration (FDA);
332		-	11.7 (B) a supply lasting a patient for fewer than 30 days based on recommended dosage
333		-	11.8approved for labeling by the FDA; or
334		-	11.9 (C) one unit of the drug if the labeling approved by the FDA does not recommend a
335		-	11.10finite dosage; and
336		-	11.11 (ii) is increased by 200 percent or more during the immediate preceding 12-month period,
337		-	11.12as determined by the difference between the resulting WAC and the average of the WAC
338		-	11.13reported over the preceding 12 months, after adjusting for changes in the CPI.
339		-	11.14 (b) The board, in consultation with the advisory council and the commissioner of health,
340		-	11.15may identify prescription drug products not described in paragraph (a) that may impose
341		-	11.16costs that create significant affordability challenges for the state health care system or for
342		-	11.17patients, including but not limited to drugs to address public health emergencies.
343		-	11.18 (c) The board shall make available to the public the names and related price information
344		-	11.19of the prescription drug products identified under this subdivision, with the exception of
345		-	11.20information determined by the board to be proprietary under the standards developed by
346		-	11.21the board under section 62J.91, subdivision 3, and information provided by the commissioner
347		-	11.22of health classified as not public data under section 13.02, subdivision 8a, or as trade secret
348		-	11.23information under section 13.37, subdivision 1, paragraph (b), or as trade secret information
349		-	11.24under the Defend Trade Secrets Act of 2016, United States Code, title 18, section 1836, as
350		-	11.25amended.
351		-	11.26 Subd. 3.Determination to proceed with review.(a) The board may initiate a cost
352		-	11.27review of a prescription drug product identified by the board under this section.
353		-	11.28 (b) The board shall consider requests by the public for the board to proceed with a cost
354		-	11.29review of any prescription drug product identified under this section.
355		-	11.30 (c) If there is no consensus among the members of the board on whether to initiate a
356		-	11.31cost review of a prescription drug product, any member of the board may request a vote to
357		-	11.32determine whether to review the cost of the prescription drug product.
358		-	11Sec. 12.
359		-	S0168-2 2nd EngrossmentSF168 REVISOR SGS 12.1 Sec. 13. [62J.91] PRESCRIPTION DRUG PRODUCT REVIEWS.
360		-	12.2 Subdivision 1.General.Once a decision by the board has been made to proceed with
361		-	12.3a cost review of a prescription drug product, the board shall conduct the review and make
362		-	12.4a determination as to whether appropriate utilization of the prescription drug under review,
363		-	12.5based on utilization that is consistent with the United States Food and Drug Administration
364		-	12.6(FDA) label or standard medical practice, has led or will lead to affordability challenges
365		-	12.7for the state health care system or for patients.
366		-	12.8 Subd. 2.Review considerations.In reviewing the cost of a prescription drug product,
367		-	12.9the board may consider the following factors:
368		-	12.10 (1) the price at which the prescription drug product has been and will be sold in the state;
369		-	12.11 (2) manufacturer monetary price concessions, discounts, or rebates, and drug-specific
370		-	12.12patient assistance;
371		-	12.13 (3) the price of therapeutic alternatives;
372		-	12.14 (4) the cost to group purchasers based on patient access consistent with the FDA-labeled
373		-	12.15indications and standard medical practice;
374		-	12.16 (5) measures of patient access, including cost-sharing and other metrics;
375		-	12.17 (6) the extent to which the attorney general or a court has determined that a price increase
376		-	12.18for a generic or off-patent prescription drug product was excessive under sections 62J.842
377		-	12.19and 62J.844;
378		-	12.20 (7) any information a manufacturer chooses to provide; and
379		-	12.21 (8) any other factors as determined by the board.
380		-	12.22 Subd. 3.Public data; proprietary information.(a) Any submission made to the board
381		-	12.23related to a drug cost review must be made available to the public with the exception of
382		-	12.24information determined by the board to be proprietary and information provided by the
383		-	12.25commissioner of health classified as not public data under section 13.02, subdivision 8a, or
384		-	12.26as trade secret information under section 13.37, subdivision 1, paragraph (b), or as trade
385		-	12.27secret information under the Defend Trade Secrets Act of 2016, United States Code, title
386		-	12.2818, section 1836, as amended.
387		-	12.29 (b) The board shall establish the standards for the information to be considered proprietary
388		-	12.30under paragraph (a) and section 62J.90, subdivision 2, including standards for heightened
389		-	12.31consideration of proprietary information for submissions for a cost review of a drug that is
390		-	12.32not yet approved by the FDA.
	324	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 11.1 (i) is $100 or more, after adjusting for changes in the CPI, for:
	325	+	11.2 (A) a 30-day supply lasting a patient for 30 consecutive days based on the recommended
	326	+	11.3dosage approved for labeling by the United States Food and Drug Administration (FDA);
	327	+	11.4 (B) a supply lasting a patient for fewer than 30 days based on recommended dosage
	328	+	11.5approved for labeling by the FDA; or
	329	+	11.6 (C) one unit of the drug if the labeling approved by the FDA does not recommend a
	330	+	11.7finite dosage; and
	331	+	11.8 (ii) is increased by 200 percent or more during the immediate preceding 12-month period,
	332	+	11.9as determined by the difference between the resulting WAC and the average of the WAC
	333	+	11.10reported over the preceding 12 months, after adjusting for changes in the CPI.
	334	+	11.11 (b) The board, in consultation with the advisory council and the commissioner of health,
	335	+	11.12may identify prescription drug products not described in paragraph (a) that may impose
	336	+	11.13costs that create significant affordability challenges for the state health care system or for
	337	+	11.14patients, including but not limited to drugs to address public health emergencies.
	338	+	11.15 (c) The board shall make available to the public the names and related price information
	339	+	11.16of the prescription drug products identified under this subdivision, with the exception of
	340	+	11.17information determined by the board to be proprietary under the standards developed by
	341	+	11.18the board under section 62J.91, subdivision 3, and information provided by the commissioner
	342	+	11.19of health classified as not public data under section 13.02, subdivision 8a, or as trade secret
	343	+	11.20information under section 13.37, subdivision 1, paragraph (b), or as trade secret information
	344	+	11.21under the Defend Trade Secrets Act of 2016, United States Code, title 18, section 1836, as
	345	+	11.22amended.
	346	+	11.23 Subd. 3.Determination to proceed with review.(a) The board may initiate a cost
	347	+	11.24review of a prescription drug product identified by the board under this section.
	348	+	11.25 (b) The board shall consider requests by the public for the board to proceed with a cost
	349	+	11.26review of any prescription drug product identified under this section.
	350	+	11.27 (c) If there is no consensus among the members of the board on whether to initiate a
	351	+	11.28cost review of a prescription drug product, any member of the board may request a vote to
	352	+	11.29determine whether to review the cost of the prescription drug product.
	353	+	11.30Sec. 13. [62J.91] PRESCRIPTION DRUG PRODUCT REVIEWS.
	354	+	11.31 Subdivision 1.General.Once a decision by the board has been made to proceed with
	355	+	11.32a cost review of a prescription drug product, the board shall conduct the review and make
	356	+	11Sec. 13.
	357	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 12.1a determination as to whether appropriate utilization of the prescription drug under review,
	358	+	12.2based on utilization that is consistent with the United States Food and Drug Administration
	359	+	12.3(FDA) label or standard medical practice, has led or will lead to affordability challenges
	360	+	12.4for the state health care system or for patients.
	361	+	12.5 Subd. 2.Review considerations.In reviewing the cost of a prescription drug product,
	362	+	12.6the board may consider the following factors:
	363	+	12.7 (1) the price at which the prescription drug product has been and will be sold in the state;
	364	+	12.8 (2) manufacturer monetary price concessions, discounts, or rebates, and drug-specific
	365	+	12.9patient assistance;
	366	+	12.10 (3) the price of therapeutic alternatives;
	367	+	12.11 (4) the cost to group purchasers based on patient access consistent with the FDA-labeled
	368	+	12.12indications and standard medical practice;
	369	+	12.13 (5) measures of patient access, including cost-sharing and other metrics;
	370	+	12.14 (6) the extent to which the attorney general or a court has determined that a price increase
	371	+	12.15for a generic or off-patent prescription drug product was excessive under sections 62J.842
	372	+	12.16and 62J.844;
	373	+	12.17 (7) any information a manufacturer chooses to provide; and
	374	+	12.18 (8) any other factors as determined by the board.
	375	+	12.19 Subd. 3.Public data; proprietary information.(a) Any submission made to the board
	376	+	12.20related to a drug cost review must be made available to the public with the exception of
	377	+	12.21information determined by the board to be proprietary and information provided by the
	378	+	12.22commissioner of health classified as not public data under section 13.02, subdivision 8a, or
	379	+	12.23as trade secret information under section 13.37, subdivision 1, paragraph (b), or as trade
	380	+	12.24secret information under the Defend Trade Secrets Act of 2016, United States Code, title
	381	+	12.2518, section 1836, as amended.
	382	+	12.26 (b) The board shall establish the standards for the information to be considered proprietary
	383	+	12.27under paragraph (a) and section 62J.90, subdivision 2, including standards for heightened
	384	+	12.28consideration of proprietary information for submissions for a cost review of a drug that is
	385	+	12.29not yet approved by the FDA.
	386	+	12.30 (c) Prior to the board establishing the standards under paragraph (b), the public shall be
	387	+	12.31provided notice and the opportunity to submit comments.
391	388		12Sec. 13.
392		-	S0168-2 2nd EngrossmentSF168 REVISOR SGS 13.1 (c) Prior to the board establishing the standards under paragraph (b), the public shall be
393		-	13.2provided notice and the opportunity to submit comments.
394		-	13.3 (d) The establishment of standards under this subdivision is exempt from the rulemaking
395		-	13.4requirements under chapter 14, and section 14.386 does not apply.
396		-	13.5 Sec. 14. [62J.92] DETERMINATIONS; COMPLIANCE; REMEDIES.
397		-	13.6 Subdivision 1.Upper payment limit.(a) In the event the board finds that the spending
398		-	13.7on a prescription drug product reviewed under section 62J.91 creates an affordability
399		-	13.8challenge for the state health care system or for patients, the board shall establish an upper
400		-	13.9payment limit after considering:
401		-	13.10 (1) extraordinary supply costs, if applicable;
402		-	13.11 (2) the range of prices at which the drug is sold in the United States according to one or
403		-	13.12more pricing files accessed under section 62J.90, subdivision 1, and the range at which
404		-	13.13pharmacies are reimbursed in Canada; and
405		-	13.14 (3) any other relevant pricing and administrative cost information for the drug.
406		-	13.15 (b) An upper payment limit applies to all purchases of, and payer reimbursements for,
407		-	13.16a prescription drug that is dispensed or administered to individuals in the state in person,
408		-	13.17by mail, or by other means, and for which an upper payment limit has been established.
409		-	13.18 Subd. 2.Implementation and administration of the upper payment limit.(a) An
410		-	13.19upper payment limit may take effect no sooner than 120 days following the date of its public
411		-	13.20release by the board.
412		-	13.21 (b) When setting an upper payment limit for a drug subject to the Medicare maximum
413		-	13.22fair price under United States Code, title 42, section 1191(c), the board shall set the upper
414		-	13.23payment limit at the Medicare maximum fair price.
415		-	13.24 (c) Health plan companies and pharmacy benefit managers shall report annually to the
416		-	13.25board, in the form and manner specified by the board, on how cost savings resulting from
417		-	13.26the establishment of an upper payment limit have been used by the health plan company or
418		-	13.27pharmacy benefit manager to benefit enrollees, including but not limited to reducing enrollee
419		-	13.28cost-sharing.
420		-	13.29 Subd. 3.Noncompliance.(a) The board shall, and other persons may, notify the Office
421		-	13.30of the Attorney General of a potential failure by an entity subject to an upper payment limit
422		-	13.31to comply with that limit.
	389	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 13.1 (d) The establishment of standards under this subdivision is exempt from the rulemaking
	390	+	13.2requirements under chapter 14, and section 14.386 does not apply.
	391	+	13.3 Sec. 14. [62J.92] DETERMINATIONS; COMPLIANCE; REMEDIES.
	392	+	13.4 Subdivision 1.Upper payment limit.(a) In the event the board finds that the spending
	393	+	13.5on a prescription drug product reviewed under section 62J.91 creates an affordability
	394	+	13.6challenge for the state health care system or for patients, the board shall establish an upper
	395	+	13.7payment limit after considering:
	396	+	13.8 (1) extraordinary supply costs, if applicable;
	397	+	13.9 (2) the range of prices at which the drug is sold in the United States according to one or
	398	+	13.10more pricing files accessed under section 62J.90, subdivision 1, and the range at which
	399	+	13.11pharmacies are reimbursed in Canada; and
	400	+	13.12 (3) any other relevant pricing and administrative cost information for the drug.
	401	+	13.13 (b) An upper payment limit applies to all purchases of, and payer reimbursements for,
	402	+	13.14a prescription drug that is dispensed or administered to individuals in the state in person,
	403	+	13.15by mail, or by other means, and for which an upper payment limit has been established.
	404	+	13.16 Subd. 2.Implementation and administration of the upper payment limit.(a) An
	405	+	13.17upper payment limit may take effect no sooner than 120 days following the date of its public
	406	+	13.18release by the board.
	407	+	13.19 (b) When setting an upper payment limit for a drug subject to the Medicare maximum
	408	+	13.20fair price under United States Code, title 42, section 1191(c), the board shall set the upper
	409	+	13.21payment limit at the Medicare maximum fair price.
	410	+	13.22 (c) Health plan companies and pharmacy benefit managers shall report annually to the
	411	+	13.23board, in the form and manner specified by the board, on how cost savings resulting from
	412	+	13.24the establishment of an upper payment limit have been used by the health plan company or
	413	+	13.25pharmacy benefit manager to benefit enrollees, including but not limited to reducing enrollee
	414	+	13.26cost-sharing.
	415	+	13.27 Subd. 3.Noncompliance.(a) The board shall, and other persons may, notify the Office
	416	+	13.28of the Attorney General of a potential failure by an entity subject to an upper payment limit
	417	+	13.29to comply with that limit.
	418	+	13.30 (b) If the Office of the Attorney General finds that an entity was noncompliant with the
	419	+	13.31upper payment limit requirements, the attorney general may pursue remedies consistent
	420	+	13.32with chapter 8 or appropriate criminal charges if there is evidence of intentional profiteering.
423	421		13Sec. 14.
424		-	S0168-2 2nd EngrossmentSF168 REVISOR SGS 14.1 (b) If the Office of the Attorney General finds that an entity was noncompliant with the
425		-	14.2upper payment limit requirements, the attorney general may pursue remedies consistent
426		-	14.3with chapter 8 or appropriate criminal charges if there is evidence of intentional profiteering.
427		-	14.4 (c) An entity who obtains price concessions from a drug manufacturer that result in a
428		-	14.5lower net cost to the stakeholder than the upper payment limit established by the board is
429		-	14.6not considered noncompliant.
430		-	14.7 (d) The Office of the Attorney General may provide guidance to stakeholders concerning
431		-	14.8activities that could be considered noncompliant.
432		-	14.9 Subd. 4.Appeals.(a) Persons affected by a decision of the board may request an appeal
433		-	14.10of the board's decision within 30 days of the date of the decision. The board shall hear the
434		-	14.11appeal and render a decision within 60 days of the hearing.
435		-	14.12 (b) All appeal decisions are subject to judicial review in accordance with chapter 14.
436		-	14.13Sec. 15. [62J.93] REPORTS.
437		-	14.14 Beginning March 1, 2024, and each March 1 thereafter, the board shall submit a report
438		-	14.15to the governor and legislature on general price trends for prescription drug products and
439		-	14.16the number of prescription drug products that were subject to the board's cost review and
440		-	14.17analysis, including the result of any analysis as well as the number and disposition of appeals
441		-	14.18and judicial reviews.
442		-	14.19Sec. 16. [62J.94] ERISA PLANS AND MEDICARE DRUG PLANS.
443		-	14.20 (a) Nothing in sections 62J.85 to 62J.95 shall be construed to require ERISA plans or
444		-	14.21Medicare Part D plans to comply with decisions of the board. ERISA plans or Medicare
445		-	14.22Part D plans are free to choose to exceed the upper payment limit established by the board
446		-	14.23under section 62J.92.
447		-	14.24 (b) Providers who dispense and administer drugs in the state must bill all payers no more
448		-	14.25than the upper payment limit without regard to whether an ERISA plan or Medicare Part
449		-	14.26D plan chooses to reimburse the provider in an amount greater than the upper payment limit
450		-	14.27established by the board.
451		-	14.28 (c) For purposes of this section, an ERISA plan or group health plan is an employee
452		-	14.29welfare benefit plan established by or maintained by an employer or an employee
453		-	14.30organization, or both, that provides employer sponsored health coverage to employees and
454		-	14.31the employee's dependents and is subject to the Employee Retirement Income Security Act
455		-	14.32of 1974 (ERISA).
	422	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 14.1 (c) An entity who obtains price concessions from a drug manufacturer that result in a
	423	+	14.2lower net cost to the stakeholder than the upper payment limit established by the board is
	424	+	14.3not considered noncompliant.
	425	+	14.4 (d) The Office of the Attorney General may provide guidance to stakeholders concerning
	426	+	14.5activities that could be considered noncompliant.
	427	+	14.6 Subd. 4.Appeals.(a) Persons affected by a decision of the board may request an appeal
	428	+	14.7of the board's decision within 30 days of the date of the decision. The board shall hear the
	429	+	14.8appeal and render a decision within 60 days of the hearing.
	430	+	14.9 (b) All appeal decisions are subject to judicial review in accordance with chapter 14.
	431	+	14.10Sec. 15. [62J.93] REPORTS.
	432	+	14.11 Beginning March 1, 2024, and each March 1 thereafter, the board shall submit a report
	433	+	14.12to the governor and legislature on general price trends for prescription drug products and
	434	+	14.13the number of prescription drug products that were subject to the board's cost review and
	435	+	14.14analysis, including the result of any analysis as well as the number and disposition of appeals
	436	+	14.15and judicial reviews.
	437	+	14.16Sec. 16. [62J.94] ERISA PLANS AND MEDICARE DRUG PLANS.
	438	+	14.17 (a) Nothing in sections 62J.85 to 62J.95 shall be construed to require ERISA plans or
	439	+	14.18Medicare Part D plans to comply with decisions of the board. ERISA plans or Medicare
	440	+	14.19Part D plans are free to choose to exceed the upper payment limit established by the board
	441	+	14.20under section 62J.92.
	442	+	14.21 (b) Providers who dispense and administer drugs in the state must bill all payers no more
	443	+	14.22than the upper payment limit without regard to whether an ERISA plan or Medicare Part
	444	+	14.23D plan chooses to reimburse the provider in an amount greater than the upper payment limit
	445	+	14.24established by the board.
	446	+	14.25 (c) For purposes of this section, an ERISA plan or group health plan is an employee
	447	+	14.26welfare benefit plan established by or maintained by an employer or an employee
	448	+	14.27organization, or both, that provides employer sponsored health coverage to employees and
	449	+	14.28the employee's dependents and is subject to the Employee Retirement Income Security Act
	450	+	14.29of 1974 (ERISA).
456	451		14Sec. 16.
457		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 15.1 Sec. 17. [62J.95] SEVERABILITY.
	452	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 15.1 Sec. 17. [62J.95] SEVERABILITY.
458	453		15.2 If any provision of sections 62J.85 to 62J.94 or the application thereof to any person or
459	454		15.3circumstance is held invalid for any reason in a court of competent jurisdiction, the invalidity
460	455		15.4does not affect other provisions or any other application of sections 62J.85 to 62J.94 that
461	456		15.5can be given effect without the invalid provision or application.
462	457		15.6 Sec. 18. Minnesota Statutes 2022, section 151.071, subdivision 1, is amended to read:
463	458		15.7 Subdivision 1.Forms of disciplinary action.When the board finds that a licensee,
464	459		15.8registrant, or applicant has engaged in conduct prohibited under subdivision 2, it may do
465	460		15.9one or more of the following:
466	461		15.10 (1) deny the issuance of a license or registration;
467	462		15.11 (2) refuse to renew a license or registration;
468	463		15.12 (3) revoke the license or registration;
469	464		15.13 (4) suspend the license or registration;
470	465		15.14 (5) impose limitations, conditions, or both on the license or registration, including but
471	466		15.15not limited to: the limitation of practice to designated settings; the limitation of the scope
472	467		15.16of practice within designated settings; the imposition of retraining or rehabilitation
473	468		15.17requirements; the requirement of practice under supervision; the requirement of participation
474	469		15.18in a diversion program such as that established pursuant to section 214.31 or the conditioning
475	470		15.19of continued practice on demonstration of knowledge or skills by appropriate examination
476	471		15.20or other review of skill and competence;
477	472		15.21 (6) impose a civil penalty not exceeding $10,000 for each separate violation, except that
478	473		15.22a civil penalty not exceeding $25,000 may be imposed for each separate violation of section
479	474		15.2362J.842, the amount of the civil penalty to be fixed so as to deprive a licensee or registrant
480	475		15.24of any economic advantage gained by reason of the violation, to discourage similar violations
481	476		15.25by the licensee or registrant or any other licensee or registrant, or to reimburse the board
482	477		15.26for the cost of the investigation and proceeding, including but not limited to, fees paid for
483	478		15.27services provided by the Office of Administrative Hearings, legal and investigative services
484	479		15.28provided by the Office of the Attorney General, court reporters, witnesses, reproduction of
485	480		15.29records, board members' per diem compensation, board staff time, and travel costs and
486	481		15.30expenses incurred by board staff and board members; and
487	482		15.31 (7) reprimand the licensee or registrant.
488	483		15Sec. 18.
489		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 16.1 Sec. 19. Minnesota Statutes 2022, section 151.071, subdivision 2, is amended to read:
	484	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 16.1 Sec. 19. Minnesota Statutes 2022, section 151.071, subdivision 2, is amended to read:
490	485		16.2 Subd. 2.Grounds for disciplinary action.The following conduct is prohibited and is
491	486		16.3grounds for disciplinary action:
492	487		16.4 (1) failure to demonstrate the qualifications or satisfy the requirements for a license or
493	488		16.5registration contained in this chapter or the rules of the board. The burden of proof is on
494	489		16.6the applicant to demonstrate such qualifications or satisfaction of such requirements;
495	490		16.7 (2) obtaining a license by fraud or by misleading the board in any way during the
496	491		16.8application process or obtaining a license by cheating, or attempting to subvert the licensing
497	492		16.9examination process. Conduct that subverts or attempts to subvert the licensing examination
498	493		16.10process includes, but is not limited to: (i) conduct that violates the security of the examination
499	494		16.11materials, such as removing examination materials from the examination room or having
500	495		16.12unauthorized possession of any portion of a future, current, or previously administered
501	496		16.13licensing examination; (ii) conduct that violates the standard of test administration, such as
502	497		16.14communicating with another examinee during administration of the examination, copying
503	498		16.15another examinee's answers, permitting another examinee to copy one's answers, or
504	499		16.16possessing unauthorized materials; or (iii) impersonating an examinee or permitting an
505	500		16.17impersonator to take the examination on one's own behalf;
506	501		16.18 (3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a pharmacist
507	502		16.19or pharmacy license, or applicant for a pharmacy technician or pharmacist intern registration,
508	503		16.20conviction of a felony reasonably related to the practice of pharmacy. Conviction as used
509	504		16.21in this subdivision includes a conviction of an offense that if committed in this state would
510	505		16.22be deemed a felony without regard to its designation elsewhere, or a criminal proceeding
511	506		16.23where a finding or verdict of guilt is made or returned but the adjudication of guilt is either
512	507		16.24withheld or not entered thereon. The board may delay the issuance of a new license or
513	508		16.25registration if the applicant has been charged with a felony until the matter has been
514	509		16.26adjudicated;
515	510		16.27 (4) for a facility, other than a pharmacy, licensed or registered by the board, if an owner
516	511		16.28or applicant is convicted of a felony reasonably related to the operation of the facility. The
517	512		16.29board may delay the issuance of a new license or registration if the owner or applicant has
518	513		16.30been charged with a felony until the matter has been adjudicated;
519	514		16.31 (5) for a controlled substance researcher, conviction of a felony reasonably related to
520	515		16.32controlled substances or to the practice of the researcher's profession. The board may delay
521	516		16.33the issuance of a registration if the applicant has been charged with a felony until the matter
522	517		16.34has been adjudicated;
523	518		16Sec. 19.
524		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 17.1 (6) disciplinary action taken by another state or by one of this state's health licensing
	519	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 17.1 (6) disciplinary action taken by another state or by one of this state's health licensing
525	520		17.2agencies:
526	521		17.3 (i) revocation, suspension, restriction, limitation, or other disciplinary action against a
527	522		17.4license or registration in another state or jurisdiction, failure to report to the board that
528	523		17.5charges or allegations regarding the person's license or registration have been brought in
529	524		17.6another state or jurisdiction, or having been refused a license or registration by any other
530	525		17.7state or jurisdiction. The board may delay the issuance of a new license or registration if an
531	526		17.8investigation or disciplinary action is pending in another state or jurisdiction until the
532	527		17.9investigation or action has been dismissed or otherwise resolved; and
533	528		17.10 (ii) revocation, suspension, restriction, limitation, or other disciplinary action against a
534	529		17.11license or registration issued by another of this state's health licensing agencies, failure to
535	530		17.12report to the board that charges regarding the person's license or registration have been
536	531		17.13brought by another of this state's health licensing agencies, or having been refused a license
537	532		17.14or registration by another of this state's health licensing agencies. The board may delay the
538	533		17.15issuance of a new license or registration if a disciplinary action is pending before another
539	534		17.16of this state's health licensing agencies until the action has been dismissed or otherwise
540	535		17.17resolved;
541	536		17.18 (7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation of
542	537		17.19any order of the board, of any of the provisions of this chapter or any rules of the board or
543	538		17.20violation of any federal, state, or local law or rule reasonably pertaining to the practice of
544	539		17.21pharmacy;
545	540		17.22 (8) for a facility, other than a pharmacy, licensed by the board, violations of any order
546	541		17.23of the board, of any of the provisions of this chapter or the rules of the board or violation
547	542		17.24of any federal, state, or local law relating to the operation of the facility;
548	543		17.25 (9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm the
549	544		17.26public, or demonstrating a willful or careless disregard for the health, welfare, or safety of
550	545		17.27a patient; or pharmacy practice that is professionally incompetent, in that it may create
551	546		17.28unnecessary danger to any patient's life, health, or safety, in any of which cases, proof of
552	547		17.29actual injury need not be established;
553	548		17.30 (10) aiding or abetting an unlicensed person in the practice of pharmacy, except that it
554	549		17.31is not a violation of this clause for a pharmacist to supervise a properly registered pharmacy
555	550		17.32technician or pharmacist intern if that person is performing duties allowed by this chapter
556	551		17.33or the rules of the board;
557	552		17Sec. 19.
558		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 18.1 (11) for an individual licensed or registered by the board, adjudication as mentally ill
	553	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 18.1 (11) for an individual licensed or registered by the board, adjudication as mentally ill
559	554		18.2or developmentally disabled, or as a chemically dependent person, a person dangerous to
560	555		18.3the public, a sexually dangerous person, or a person who has a sexual psychopathic
561	556		18.4personality, by a court of competent jurisdiction, within or without this state. Such
562	557		18.5adjudication shall automatically suspend a license for the duration thereof unless the board
563	558		18.6orders otherwise;
564	559		18.7 (12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as specified
565	560		18.8in the board's rules. In the case of a pharmacy technician, engaging in conduct specified in
566	561		18.9board rules that would be unprofessional if it were engaged in by a pharmacist or pharmacist
567	562		18.10intern or performing duties specifically reserved for pharmacists under this chapter or the
568	563		18.11rules of the board;
569	564		18.12 (13) for a pharmacy, operation of the pharmacy without a pharmacist present and on
570	565		18.13duty except as allowed by a variance approved by the board;
571	566		18.14 (14) for a pharmacist, the inability to practice pharmacy with reasonable skill and safety
572	567		18.15to patients by reason of illness, use of alcohol, drugs, narcotics, chemicals, or any other type
573	568		18.16of material or as a result of any mental or physical condition, including deterioration through
574	569		18.17the aging process or loss of motor skills. In the case of registered pharmacy technicians,
575	570		18.18pharmacist interns, or controlled substance researchers, the inability to carry out duties
576	571		18.19allowed under this chapter or the rules of the board with reasonable skill and safety to
577	572		18.20patients by reason of illness, use of alcohol, drugs, narcotics, chemicals, or any other type
578	573		18.21of material or as a result of any mental or physical condition, including deterioration through
579	574		18.22the aging process or loss of motor skills;
580	575		18.23 (15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical gas
581	576		18.24dispenser, or controlled substance researcher, revealing a privileged communication from
582	577		18.25or relating to a patient except when otherwise required or permitted by law;
583	578		18.26 (16) for a pharmacist or pharmacy, improper management of patient records, including
584	579		18.27failure to maintain adequate patient records, to comply with a patient's request made pursuant
585	580		18.28to sections 144.291 to 144.298, or to furnish a patient record or report required by law;
586	581		18.29 (17) fee splitting, including without limitation:
587	582		18.30 (i) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate,
588	583		18.31kickback, or other form of remuneration, directly or indirectly, for the referral of patients;
589	584		18.32 (ii) referring a patient to any health care provider as defined in sections 144.291 to
590	585		18.33144.298 in which the licensee or registrant has a financial or economic interest as defined
591	586		18Sec. 19.
592		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 19.1in section 144.6521, subdivision 3, unless the licensee or registrant has disclosed the
	587	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 19.1in section 144.6521, subdivision 3, unless the licensee or registrant has disclosed the
593	588		19.2licensee's or registrant's financial or economic interest in accordance with section 144.6521;
594	589		19.3and
595	590		19.4 (iii) any arrangement through which a pharmacy, in which the prescribing practitioner
596	591		19.5does not have a significant ownership interest, fills a prescription drug order and the
597	592		19.6prescribing practitioner is involved in any manner, directly or indirectly, in setting the price
598	593		19.7for the filled prescription that is charged to the patient, the patient's insurer or pharmacy
599	594		19.8benefit manager, or other person paying for the prescription or, in the case of veterinary
600	595		19.9patients, the price for the filled prescription that is charged to the client or other person
601	596		19.10paying for the prescription, except that a veterinarian and a pharmacy may enter into such
602	597		19.11an arrangement provided that the client or other person paying for the prescription is notified,
603	598		19.12in writing and with each prescription dispensed, about the arrangement, unless such
604	599		19.13arrangement involves pharmacy services provided for livestock, poultry, and agricultural
605	600		19.14production systems, in which case client notification would not be required;
606	601		19.15 (18) engaging in abusive or fraudulent billing practices, including violations of the
607	602		19.16federal Medicare and Medicaid laws or state medical assistance laws or rules;
608	603		19.17 (19) engaging in conduct with a patient that is sexual or may reasonably be interpreted
609	604		19.18by the patient as sexual, or in any verbal behavior that is seductive or sexually demeaning
610	605		19.19to a patient;
611	606		19.20 (20) failure to make reports as required by section 151.072 or to cooperate with an
612	607		19.21investigation of the board as required by section 151.074;
613	608		19.22 (21) knowingly providing false or misleading information that is directly related to the
614	609		19.23care of a patient unless done for an accepted therapeutic purpose such as the dispensing and
615	610		19.24administration of a placebo;
616	611		19.25 (22) aiding suicide or aiding attempted suicide in violation of section 609.215 as
617	612		19.26established by any of the following:
618	613		19.27 (i) a copy of the record of criminal conviction or plea of guilty for a felony in violation
619	614		19.28of section 609.215, subdivision 1 or 2;
620	615		19.29 (ii) a copy of the record of a judgment of contempt of court for violating an injunction
621	616		19.30issued under section 609.215, subdivision 4;
622	617		19.31 (iii) a copy of the record of a judgment assessing damages under section 609.215,
623	618		19.32subdivision 5; or
624	619		19Sec. 19.
625		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~ 20.1 (iv) a finding by the board that the person violated section 609.215, subdivision 1 or 2.
	620	+	S0168-1 1st EngrossmentSF168 REVISOR AGW 20.1 (iv) a finding by the board that the person violated section 609.215, subdivision 1 or 2.
626	621		20.2The board must investigate any complaint of a violation of section 609.215, subdivision 1
627	622		20.3or 2;
628	623		20.4 (23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license. For
629	624		20.5a pharmacist intern, pharmacy technician, or controlled substance researcher, performing
630	625		20.6duties permitted to such individuals by this chapter or the rules of the board under a lapsed
631	626		20.7or nonrenewed registration. For a facility required to be licensed under this chapter, operation
632	627		20.8of the facility under a lapsed or nonrenewed license or registration; and
633	628		20.9 (24) for a pharmacist, pharmacist intern, or pharmacy technician, termination or discharge
634	629		20.10from the health professionals services program for reasons other than the satisfactory
635	630		20.11completion of the program.; and
636	631		20.12 (25) for a manufacturer, a violation of section 62J.842 or section 62J.845.
637	632		20.13Sec. 20. APPROPRIATION.
638	633		20.14 $....... in fiscal year 2024 and $....... in fiscal year 2025 are appropriated from the general
639	634		20.15fund to the Prescription Drug Affordability Board established under Minnesota Statutes,
640	635		20.16section 62J.87, for implementation of the Prescription Drug Affordability Act.
641	636		20Sec. 20.
642		-	S0168-~~2 2nd~~ EngrossmentSF168 REVISOR ~~SGS~~
	637	+	S0168-1 1st EngrossmentSF168 REVISOR AGW