Minnesota 2025 2025-2026 Regular Session

Minnesota House Bill HF3054 Introduced / Bill

Filed 04/01/2025

                    1.1	A bill for an act​
1.2 relating to health; modifying provisions for prescription drug transparency;​
1.3 amending Minnesota Statutes 2024, sections 62J.461, subdivisions 3, 4, 5; 62J.84,​
1.4 subdivisions 2, 3, 6, 10, 11, 12, 13, 14, 15.​
1.5BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:​
1.6 Section 1. Minnesota Statutes 2024, section 62J.461, subdivision 3, is amended to read:​
1.7 Subd. 3.Reporting by covered entities to the commissioner.(a) Each 340B covered​
1.8entity shall report to the commissioner by April 1 of each year the following information​
1.9for transactions conducted by the 340B covered entity or on its behalf, and related to its​
1.10participation in the federal 340B program for the previous calendar year:​
1.11 (1) the aggregated acquisition cost for prescription drugs obtained under the 340B​
1.12program;​
1.13 (2) the aggregated payment amount received for drugs obtained under the 340B program​
1.14and dispensed or administered to patients;:​
1.15 (i) that are net of the contracted price for insurance claims payments; and​
1.16 (ii) that reflect the portion of payment received from grants, cash, or other payment types​
1.17that relate to the dispensing or administering of drugs obtained under the 340B program;​
1.18 (3) the number of pricing units dispensed or administered for prescription drugs described​
1.19in clause (2); and​
1.20 (4) the aggregated payments made:​
1.21 (i) to contract pharmacies to dispense drugs obtained under the 340B program;​
1​Section 1.​
REVISOR EB/VJ 25-00304​01/30/25 ​
State of Minnesota​
This Document can be made available​
in alternative formats upon request​
HOUSE OF REPRESENTATIVES​
H. F. No.  3054​
NINETY-FOURTH SESSION​
Authored by Bierman​04/02/2025​
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​
2.2managing any aspect of the covered entity's 340B program; and​
2.3 (iii) for all other internal, direct expenses related to administering the 340B program​
2.4with a detailed description of the direct costs included.​
2.5The information under clauses (2) and (3) must be reported by payer type, including but​
2.6not limited to commercial insurance, medical assistance, MinnesotaCare, and Medicare, in​
2.7the form and manner prescribed by the commissioner.​
2.8 (b) For covered entities that are hospitals, the information required under paragraph (a),​
2.9clauses (1) to (3), must also be reported at the national drug code level for the 50 most​
2.10frequently dispensed or administered drugs by the facility under the 340B program.​
2.11 (c) Data submitted to the commissioner under paragraphs (a) and (b) are classified as​
2.12nonpublic data, as defined in section 13.02, subdivision 9.​
2.13 Sec. 2. Minnesota Statutes 2024, section 62J.461, subdivision 4, is amended to read:​
2.14 Subd. 4.Enforcement and exceptions.(a) Any health care covered entity subject to​
2.15reporting under this section that fails to provide data in the form and manner prescribed by​
2.16the commissioner is subject to the levy of a fine paid to the commissioner of up to $500 for​
2.17each day the data are past due. Any fine levied against the entity under this subdivision is​
2.18subject to the contested case and judicial review provisions of sections 14.57 and to 14.69.​
2.19 (b) The commissioner may grant an entity an extension of or exemption from the reporting​
2.20obligations under this subdivision section, upon a showing of good cause by the entity.​
2.21 Sec. 3. Minnesota Statutes 2024, section 62J.461, subdivision 5, is amended to read:​
2.22 Subd. 5.Reports to the legislature.By November 15, 2024, and by November 15 of​
2.23each year thereafter, the commissioner shall submit to the chairs and ranking minority​
2.24members of the legislative committees with jurisdiction over health care finance and policy,​
2.25a report that aggregates the data submitted under subdivision 3, paragraphs (a) and (b). The​
2.26following information must be included in the report For all 340B entities whose net 340B​
2.27revenue constitutes a significant share, as determined by the commissioner, of all net 340B​
2.28revenue across all 340B covered entities in Minnesota, the following information must also​
2.29be included in the report:​
2.30 (1) the information submitted under subdivision 2; and​
2​Sec. 3.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 3.1 (2) for each 340B entity identified in subdivision 2, that entity's 340B net revenue as​
3.2calculated using the data submitted under subdivision 3, paragraph (a), with net revenue​
3.3being subdivision 3, paragraph (a), clause (2), less the sum of subdivision 3, paragraph (a),​
3.4clauses (1) and (4).​
3.5For all other entities, the data in the report must be aggregated to the entity type or groupings​
3.6of entity types in a manner that prevents the identification of an individual entity and any​
3.7entity's specific data value reported for an individual data element.​
3.8 Sec. 4. Minnesota Statutes 2024, section 62J.84, subdivision 2, is amended to read:​
3.9 Subd. 2.Definitions.(a) For purposes of this section, the terms defined in this subdivision​
3.10have the meanings given.​
3.11 (b) "Biosimilar" means a drug that is produced or distributed pursuant to a biologics​
3.12license application approved under United States Code, title 42, section 262(K)(3).​
3.13 (c) "Brand name drug" means a drug that is produced or distributed pursuant to:​
3.14 (1) a new drug application approved under United States Code, title 21, section 355(c),​
3.15except for a generic drug as defined under Code of Federal Regulations, title 42, section​
3.16447.502; or​
3.17 (2) a biologics license application approved under United States Code, title 42, section​
3.18262(a)(c).​
3.19 (d) "Commissioner" means the commissioner of health.​
3.20 (e) "Generic drug" means a drug that is marketed or distributed pursuant to:​
3.21 (1) an abbreviated new drug application approved under United States Code, title 21,​
3.22section 355(j);​
3.23 (2) an authorized generic as defined under Code of Federal Regulations, title 42, section​
3.24447.502; or​
3.25 (3) a drug that entered the market the year before 1962 and was not originally marketed​
3.26under a new drug application.​
3.27 (f) "Manufacturer" means a drug manufacturer licensed under section 151.252.​
3.28 (g) "New prescription drug" or "new drug" means a prescription drug approved for​
3.29marketing by the United States Food and Drug Administration (FDA) for which no previous​
3.30wholesale acquisition cost has been established for comparison.​
3​Sec. 4.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 4.1 (h) "Patient assistance program" means a program that a manufacturer offers to the public​
4.2in which a consumer may reduce the consumer's out-of-pocket costs for prescription drugs​
4.3by using coupons, discount cards, prepaid gift cards, manufacturer debit cards, or by other​
4.4means.​
4.5 (i) "Prescription drug" or "drug" has the meaning provided in section 151.441, subdivision​
4.68.​
4.7 (j) "Price" means the wholesale acquisition cost as defined in United States Code, title​
4.842, section 1395w-3a(c)(6)(B).​
4.9 (k) "30-day supply" means the total daily dosage units of a prescription drug​
4.10recommended by the prescribing label approved by the FDA for 30 days. If the​
4.11FDA-approved prescribing label includes more than one recommended daily dosage, the​
4.1230-day supply is based on the maximum recommended daily dosage on the FDA-approved​
4.13prescribing label.​
4.14 (l) "Course of treatment" means the total dosage of a single prescription for a prescription​
4.15drug recommended by the FDA-approved prescribing label. If the FDA-approved prescribing​
4.16label includes more than one recommended dosage for a single course of treatment, the​
4.17course of treatment is the maximum recommended dosage on the FDA-approved prescribing​
4.18label.​
4.19 (m) "Drug product family" means a group of one or more prescription drugs that share​
4.20a unique generic drug description or nontrade name and dosage form.​
4.21 (n) "Individual salable unit" means the smallest container of product introduced into​
4.22commerce by the manufacturer or repackager that is intended by the manufacturer or​
4.23repackager for individual sale to a dispenser.​
4.24 (o) (n) "National drug code" means the three-segment code maintained by the federal​
4.25Food and Drug Administration that includes a labeler code, a product code, and a package​
4.26code for a drug product and that has been converted to an 11-digit format consisting of five​
4.27digits in the first segment, four digits in the second segment, and two digits in the third​
4.28segment. A three-segment code shall be considered converted to an 11-digit format when,​
4.29as necessary, at least one "0" has been added to the front of each segment containing less​
4.30than the specified number of digits such that each segment contains the specified number​
4.31of digits.​
4​Sec. 4.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 5.1 (p) (o) "Pharmacy" or "pharmacy provider" means a community/outpatient pharmacy​
5.2as defined in Minnesota Rules, part 6800.0100, subpart 2, that is also licensed as a pharmacy​
5.3by the Board of Pharmacy under section 151.19.​
5.4 (q) (p) "Pharmacy benefit manager" or "PBM" means an entity licensed to act as a​
5.5pharmacy benefit manager under section 62W.03.​
5.6 (r) (q) "Pricing unit" means the smallest dispensable amount of a prescription drug​
5.7product that could be dispensed or administered.​
5.8 (s) (r) "Rebate" means a discount, chargeback, or other price concession that affects the​
5.9price of a prescription drug product, regardless of whether conferred through regular​
5.10aggregate payments, on a claim-by-claim basis at the point of sale, as part of retrospective​
5.11financial reconciliations, including reconciliations that also reflect other contractual​
5.12arrangements, or by any other method. "Rebate" does not mean a bona fide service fee as​
5.13defined in Code of Federal Regulations, title 42, section 447.502.​
5.14 (t) (s) "Reporting entity" means any manufacturer, pharmacy, pharmacy benefit manager,​
5.15wholesale drug distributor, or any other entity required to submit data under this section.​
5.16 (u) (t) "Wholesale drug distributor" or "wholesaler" means an entity that:​
5.17 (1) is licensed to act as a wholesale drug distributor under section 151.47; and.​
5.18 (2) distributes prescription drugs, for which it is not the manufacturer, to persons or​
5.19entities, or both, other than a consumer or patient in the state.​
5.20 Sec. 5. Minnesota Statutes 2024, section 62J.84, subdivision 3, is amended to read:​
5.21 Subd. 3.Prescription drug price increases reporting.(a) Beginning January 1, 2022,​
5.22a drug manufacturer must submit to the commissioner the information described in paragraph​
5.23(b) for each prescription drug for which the price was $100 or greater for a 30-day supply​
5.24or for a course of treatment lasting less than 30 days and:​
5.25 (1) for brand name drugs where there is an increase of ten percent or greater in the price​
5.26over the previous 12-month period or an increase of 16 percent or greater in the price over​
5.27the previous 24-month period; and.​
5.28 (2) for generic or biosimilar drugs where there is an increase of 50 percent or greater in​
5.29the price over the previous 12-month period.​
5.30 (b) For each of the drugs described in paragraph (a), the manufacturer shall submit to​
5.31the commissioner no later than 60 days after the price increase goes into effect, in the form​
5.32and manner prescribed by the commissioner, the following information, if applicable:​
5​Sec. 5.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 6.1 (1) the description and price of the drug and the net increase, expressed as a percentage,​
6.2with the following listed separately:​
6.3 (i) the national drug code;​
6.4 (ii) the product name;​
6.5 (iii) the dosage form;​
6.6 (iv) the strength; and​
6.7 (v) the package size;​
6.8 (2) the factors that contributed to the price increase;​
6.9 (3) the name of any generic version of the prescription drug available on the market;​
6.10 (4) the year the prescription drug was introduced for sale in the United States;​
6.11 (4) (5) the introductory price of the prescription drug when it was introduced for sale in​
6.12the United States and the price of the drug on the last day of each of the five calendar years​
6.13preceding the price increase;​
6.14 (5) (6) the direct costs incurred during the previous 12-month period by the manufacturer​
6.15that are associated with the prescription drug, listed separately:​
6.16 (i) to manufacture the prescription drug;​
6.17 (ii) to market the prescription drug, including advertising costs; and​
6.18 (iii) to distribute the prescription drug;​
6.19 (7) the number of units of the prescription drug sold during the previous 12-month period;​
6.20 (6) (8) the total sales revenue for the prescription drug during the previous 12-month​
6.21period;​
6.22 (9) the total rebate payable amount accrued for the prescription drug during the previous​
6.2312-month period;​
6.24 (7) (10) the manufacturer's net profit attributable to the prescription drug during the​
6.25previous 12-month period;​
6.26 (8) (11) the total amount of financial assistance the manufacturer has provided through​
6.27patient prescription assistance programs during the previous 12-month period, if applicable;​
6.28 (9) (12) any agreement between a manufacturer and another entity contingent upon any​
6.29delay in offering to market a generic version of the prescription drug;​
6​Sec. 5.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 7.1 (10) (13) the patent expiration date of the prescription drug if it is under patent;​
7.2 (11) (14) the name and location of the company that manufactured the drug;​
7.3 (12) (15) if a brand name prescription drug, the highest price paid for the prescription​
7.4drug during the previous calendar year in the ten countries, excluding the United States,​
7.5that charged the highest single price for the prescription drug; and​
7.6 (13) (16) if the prescription drug was acquired by the manufacturer during the previous​
7.712-month period, all of the following information:​
7.8 (i) price at acquisition;​
7.9 (ii) price in the calendar year prior to acquisition;​
7.10 (iii) name of the company from which the drug was acquired;​
7.11 (iv) date of acquisition; and​
7.12 (v) acquisition price.​
7.13 (c) The manufacturer may submit any documentation necessary to support the information​
7.14reported under this subdivision.​
7.15 Sec. 6. Minnesota Statutes 2024, section 62J.84, subdivision 6, is amended to read:​
7.16 Subd. 6.Public posting of prescription drug price information.(a) The commissioner​
7.17shall post on the department's website, or may contract with a private entity or consortium​
7.18that satisfies the standards of section 62U.04, subdivision 6, to meet this requirement, the​
7.19following information:​
7.20 (1) a list of the prescription drugs reported under subdivisions 3, 4, and 11 to 14 and the​
7.21manufacturers of those prescription drugs; and​
7.22 (2) a list of reporting entities that reported prescription drug price information under​
7.23subdivisions 3, 4, and 11 to 14; and​
7.24 (2) (3) information reported to the commissioner under subdivisions 3, 4, and 11 to 14,​
7.25aggregated on a per-drug basis in a manner that does not allow the identification of a reporting​
7.26entity that is not the manufacturer of the drug.​
7.27 (b) The information must be published in an easy-to-read format and in a manner that​
7.28identifies the information that is disclosed on a per-drug basis and must not be aggregated​
7.29in a manner that prevents the identification of the prescription drug.​
7​Sec. 6.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 8.1 (c) The commissioner shall not post to the department's website or a private entity​
8.2contracting with the commissioner shall not post any information described in this section​
8.3if the information is not public data under section 13.02, subdivision 8a; or is trade secret​
8.4information under section 13.37, subdivision 1, paragraph (b); or is trade secret information​
8.5pursuant to the Defend Trade Secrets Act of 2016, United States Code, title 18, section​
8.61836, as amended. If a reporting entity believes information should be withheld from public​
8.7disclosure pursuant to this paragraph, the reporting entity must clearly and specifically​
8.8identify that information and describe the legal basis in writing when the reporting entity​
8.9submits the information under this section. If the commissioner disagrees with the reporting​
8.10entity's request to withhold information from public disclosure, the commissioner shall​
8.11provide the reporting entity written notice that the information will be publicly posted 30​
8.12days after the date of the notice.​
8.13 (d) If the commissioner withholds any information from public disclosure pursuant to​
8.14this subdivision, the commissioner shall post to the department's website a report describing​
8.15the nature of the information and the commissioner's basis for withholding the information​
8.16from disclosure.​
8.17 (e) To the extent the information required to be posted under this subdivision is collected​
8.18and made available to the public by another state, by the University of Minnesota, or through​
8.19an online drug pricing reference and analytical tool, the commissioner may reference the​
8.20availability of this drug price data from another source including, within existing​
8.21appropriations, creating the ability of the public to access the data from the source for​
8.22purposes of meeting the reporting requirements of this subdivision.​
8.23 Sec. 7. Minnesota Statutes 2024, section 62J.84, subdivision 10, is amended to read:​
8.24 Subd. 10.Notice of prescription drugs of substantial public interest.(a) No later than​
8.25January 31, 2024, and quarterly thereafter, the commissioner shall produce and post on the​
8.26department's website a list of prescription drugs that the commissioner determines to represent​
8.27a substantial public interest and for which the commissioner intends to request data under​
8.28subdivisions 11 to 14, subject to paragraph (c). The commissioner shall base its inclusion​
8.29of prescription drugs on any information the commissioner determines is relevant to providing​
8.30greater consumer awareness of the factors contributing to the cost of prescription drugs in​
8.31the state, and the commissioner shall consider drug product families that include prescription​
8.32drugs:​
8.33 (1) that triggered reporting under subdivision 3 or 4 during the previous calendar quarter;​
8​Sec. 7.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 9.1 (2) for which average claims paid amounts exceeded 125 percent of the price as of the​
9.2claim incurred date during the most recent calendar quarter for which claims paid amounts​
9.3are available; or​
9.4 (3) that are identified by members of the public during a public comment process.​
9.5 (b) Not sooner than 30 days after publicly posting the list of prescription drugs under​
9.6paragraph (a), the department shall notify, via email, reporting entities registered with the​
9.7department of:​
9.8 (1) the requirement to report under subdivisions 11 to 14.; and​
9.9 (2) the reporting period for which data must be provided.​
9.10 (c) The commissioner must not designate more than 500 prescription drugs as having a​
9.11substantial public interest in any one notice.​
9.12 (d) Notwithstanding subdivision 16, the commissioner is exempt from chapter 14,​
9.13including section 14.386, in implementing this subdivision.​
9.14 EFFECTIVE DATE.This section is effective the day following final enactment.​
9.15 Sec. 8. Minnesota Statutes 2024, section 62J.84, subdivision 11, is amended to read:​
9.16 Subd. 11.Manufacturer prescription drug substantial public interest reporting.(a)​
9.17Beginning January 1, 2024, a manufacturer must submit to the commissioner the information​
9.18described in paragraph (b) for any prescription drug:​
9.19 (1) included in a notification to report issued to the manufacturer by the department​
9.20under subdivision 10;​
9.21 (2) which the manufacturer manufactures or repackages;​
9.22 (3) for which the manufacturer sets the wholesale acquisition cost; and​
9.23 (4) for which the manufacturer has not submitted data under subdivision 3 during the​
9.24120-day period prior to the date of the notification to report.​
9.25 (b) For each of the drugs described in paragraph (a), the manufacturer shall submit to​
9.26the commissioner no later than 60 days after the date of the notification to report, in the​
9.27form and manner prescribed by the commissioner, the following information, if applicable:​
9.28 (1) a description of the drug with the following listed separately:​
9.29 (i) the national drug code;​
9.30 (ii) the product name;​
9​Sec. 8.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 10.1 (iii) the dosage form;​
10.2 (iv) the strength; and​
10.3 (v) the package size;​
10.4 (2) the price of the drug product on the later of:​
10.5 (i) the day one year prior to the date of the notification to report;​
10.6 (ii) the introduced to market date; or​
10.7 (iii) the acquisition date;​
10.8 (3) the price of the drug product on the date of the notification to report;​
10.9 (4) the year the prescription drug was introduced for sale in the United States;​
10.10 (4) (5) the introductory price of the prescription drug when it was introduced for sale in​
10.11the United States and the price of the drug on the last day of each of the five calendar years​
10.12preceding the date of the notification to report;​
10.13 (5) (6) the direct costs incurred during the 12-month period prior to the date of reporting​
10.14period specified in the notification to report by the manufacturers that are associated with​
10.15the prescription drug, listed separately:​
10.16 (i) to manufacture the prescription drug;​
10.17 (ii) to market the prescription drug, including advertising costs; and​
10.18 (iii) to distribute the prescription drug;​
10.19 (6) (7) the number of units of the prescription drug sold during the 12-month period​
10.20prior to the date of reporting period specified in the notification to report;​
10.21 (7) (8) the total sales revenue for the prescription drug during the 12-month period prior​
10.22to the date of reporting period specified in the notification to report;​
10.23 (8) (9) the total rebate payable amount accrued for the prescription drug during the​
10.2412-month period prior to the date of reporting period specified in the notification to report;​
10.25 (9) (10) the manufacturer's net profit attributable to the prescription drug during the​
10.2612-month period prior to the date of reporting period specified in the notification to report;​
10.27 (10) (11) the total amount of financial assistance the manufacturer has provided through​
10.28patient prescription assistance programs during the 12-month period prior to the date of​
10.29reporting period specified in the notification to report, if applicable;​
10​Sec. 8.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 11.1 (11) (12) any agreement between a manufacturer and another entity contingent upon​
11.2any delay in offering to market a generic version of the prescription drug;​
11.3 (12) (13) the patent expiration date of the prescription drug if the prescription drug is​
11.4under patent;​
11.5 (13) (14) the name and location of the company that manufactured the drug;​
11.6 (14) (15) if the prescription drug is a brand name prescription drug, the ten countries​
11.7other than the United States that paid the highest prices for the prescription drug during the​
11.8previous calendar year and their prices; and​
11.9 (15) (16) if the prescription drug was acquired by the manufacturer within a 12-month​
11.10period prior to the date of the reporting period specified in the notification to report, all of​
11.11the following information:​
11.12 (i) the price at acquisition;​
11.13 (ii) the price in the calendar year prior to acquisition;​
11.14 (iii) the name of the company from which the drug was acquired;​
11.15 (iv) the date of acquisition; and​
11.16 (v) the acquisition price.​
11.17 (c) The manufacturer may submit any documentation necessary to support the information​
11.18reported under this subdivision.​
11.19Sec. 9. Minnesota Statutes 2024, section 62J.84, subdivision 12, is amended to read:​
11.20 Subd. 12.Pharmacy prescription drug substantial public interest reporting.(a)​
11.21Beginning January 1, 2024, a pharmacy must submit to the commissioner the information​
11.22described in paragraph (b) for any prescription drug:​
11.23 (1) included in a notification to report issued to the pharmacy by the department under​
11.24subdivision 10.; and​
11.25 (2) that the pharmacy dispensed in Minnesota or mailed to a Minnesota address.​
11.26 (b) For each of the drugs described in paragraph (a), the pharmacy shall submit to the​
11.27commissioner no later than 60 days after the date of the notification to report, in the form​
11.28and manner prescribed by the commissioner, the following information, if applicable:​
11.29 (1) a description of the drug with the following listed separately:​
11.30 (i) the national drug code;​
11​Sec. 9.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 12.1 (ii) the product name;​
12.2 (iii) the dosage form;​
12.3 (iv) the strength; and​
12.4 (v) the package size;​
12.5 (2) the number of units of the drug acquired during the 12-month period prior to the date​
12.6of reporting period specified in the notification to report;​
12.7 (3) the total spent before rebates by the pharmacy to acquire the drug during the 12-month​
12.8period prior to the date of reporting period specified in the notification to report;​
12.9 (4) the total rebate receivable amount accrued by the pharmacy for the drug during the​
12.1012-month period prior to the date of reporting period specified in the notification to report;​
12.11 (5) the number of pricing units of the drug dispensed by the pharmacy during the​
12.1212-month period prior to the date of reporting period specified in the notification to report;​
12.13 (6) the total payment receivable by the pharmacy for dispensing the drug including​
12.14ingredient cost, dispensing fee, and administrative fees during the 12-month period prior​
12.15to the date of reporting period specified in the notification to report;​
12.16 (7) the total rebate payable amount accrued by the pharmacy for the drug during the​
12.1712-month period prior to the date of reporting period specified in the notification to report;​
12.18and​
12.19 (8) the average cash price paid by consumers per pricing unit for prescriptions dispensed​
12.20where no claim was submitted to a health care service plan or health insurer during the​
12.2112-month period prior to the date of reporting period specified in the notification to report.​
12.22 (c) The pharmacy may submit any documentation necessary to support the information​
12.23reported under this subdivision.​
12.24 (d) The commissioner may grant extensions, exemptions, or both to compliance with​
12.25the requirements of paragraphs (a) and (b) by small or independent pharmacies, if compliance​
12.26with paragraphs (a) and (b) would represent a hardship or undue burden to the pharmacy.​
12.27The commissioner may establish procedures for small or independent pharmacies to request​
12.28extensions or exemptions under this paragraph.​
12​Sec. 9.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 13.1 Sec. 10. Minnesota Statutes 2024, section 62J.84, subdivision 13, is amended to read:​
13.2 Subd. 13.PBM prescription drug substantial public interest reporting.(a) Beginning​
13.3January 1, 2024, a PBM must submit to the commissioner the information described in​
13.4paragraph (b) for any prescription drug:​
13.5 (1) included in a notification to report issued to the PBM by the department under​
13.6subdivision 10.; and​
13.7 (2) for which the PBM fulfilled pharmacy benefit management duties for Minnesota​
13.8residents.​
13.9 (b) For each of the drugs described in paragraph (a), the PBM shall submit to the​
13.10commissioner no later than 60 days after the date of the notification to report, in the form​
13.11and manner prescribed by the commissioner, the following information, if applicable:​
13.12 (1) a description of the drug with the following listed separately:​
13.13 (i) the national drug code;​
13.14 (ii) the product name;​
13.15 (iii) the dosage form;​
13.16 (iv) the strength; and​
13.17 (v) the package size;​
13.18 (2) the number of pricing units of the drug product filled for which the PBM administered​
13.19claims during the 12-month period prior to the date of reporting period specified in the​
13.20notification to report;​
13.21 (3) the total reimbursement amount accrued and payable to pharmacies for pricing units​
13.22of the drug product filled for which the PBM administered claims during the 12-month​
13.23period prior to the date of reporting period specified in the notification to report;​
13.24 (4) the total reimbursement or administrative fee amount, or both, accrued and receivable​
13.25from payers for pricing units of the drug product filled for which the PBM administered​
13.26claims during the 12-month period prior to the date of reporting period specified in the​
13.27notification to report;​
13.28 (5) the total administrative fee amount accrued and receivable from payers for pricing​
13.29units of the drug product filled during the reporting period specified in the notification to​
13.30report;​
13​Sec. 10.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 14.1 (5) (6) the total rebate receivable amount accrued by the PBM for the drug product​
14.2during the 12-month period prior to the date of reporting period specified in the notification​
14.3to report; and​
14.4 (6) (7) the total rebate payable amount accrued by the PBM for the drug product during​
14.5the 12-month period prior to the date of reporting period specified in the notification to​
14.6report.​
14.7 (c) The PBM may submit any documentation necessary to support the information​
14.8reported under this subdivision.​
14.9 Sec. 11. Minnesota Statutes 2024, section 62J.84, subdivision 14, is amended to read:​
14.10 Subd. 14.Wholesale drug distributor prescription drug substantial public interest​
14.11reporting.(a) Beginning January 1, 2024, a wholesale drug distributor that distributes​
14.12prescription drugs, for which it is not the manufacturer, to persons or entities, or both, other​
14.13than a consumer or patient in the state, must submit to the commissioner the information​
14.14described in paragraph (b) for any prescription drug:​
14.15 (1) included in a notification to report issued to the wholesale drug distributor by the​
14.16department under subdivision 10.; and​
14.17 (2) that the wholesale drug distributor distributed within or into Minnesota.​
14.18 (b) For each of the drugs described in paragraph (a), the wholesale drug distributor shall​
14.19submit to the commissioner no later than 60 days after the date of the notification to report,​
14.20in the form and manner prescribed by the commissioner, the following information, if​
14.21applicable:​
14.22 (1) a description of the drug with the following listed separately:​
14.23 (i) the national drug code;​
14.24 (ii) the product name;​
14.25 (iii) the dosage form;​
14.26 (iv) the strength; and​
14.27 (v) the package size;​
14.28 (2) the number of units of the drug product acquired by the wholesale drug distributor​
14.29during the 12-month period prior to the date of reporting period specified in the notification​
14.30to report;​
14​Sec. 11.​
REVISOR EB/VJ 25-00304​01/30/25 ​ 15.1 (3) the total spent before rebates by the wholesale drug distributor to acquire the drug​
15.2product during the 12-month period prior to the date of reporting period specified in the​
15.3notification to report;​
15.4 (4) the total rebate receivable amount accrued by the wholesale drug distributor for the​
15.5drug product during the 12-month period prior to the date of reporting period specified in​
15.6the notification to report;​
15.7 (5) the number of units of the drug product sold by the wholesale drug distributor during​
15.8the 12-month period prior to the date of reporting period specified in the notification to​
15.9report;​
15.10 (6) gross revenue from sales in the United States generated by the wholesale drug​
15.11distributor for this the drug product during the 12-month period prior to the date of reporting​
15.12period specified in the notification to report; and​
15.13 (7) total rebate payable amount accrued by the wholesale drug distributor for the drug​
15.14product during the 12-month period prior to the date of reporting period specified in the​
15.15notification to report.​
15.16 (c) The wholesale drug distributor may submit any documentation necessary to support​
15.17the information reported under this subdivision.​
15.18Sec. 12. Minnesota Statutes 2024, section 62J.84, subdivision 15, is amended to read:​
15.19 Subd. 15.Registration requirements.Beginning Effective January 1, 2024 2026, a​
15.20reporting entity subject to this chapter shall register, or update existing registration​
15.21information, with the department in a form and manner prescribed by the commissioner by​
15.22January 30 of each year.​
15​Sec. 12.​
REVISOR EB/VJ 25-00304​01/30/25 ​