2022 Minnesota Statutes

62J.84 PRESCRIPTION Next Previous DRUG Next Previous PRICE Next Previous TRANSPARENCY Next .

Subdivision 1.Short title.

This section may be cited as the " Previous Prescription Next Previous Drug Next Previous Price Next Previous Transparency Next Previous Act Next ."

Subd. 2.Definitions.

(a) For purposes of this section, the terms defined in this subdivision have the meanings given.

(b) "Biosimilar" means a Previous drug Next that is produced or distributed pursuant to a biologics license application approved under United States Code, title 42, section 262(K)(3).

(c) "Brand name Previous drug Next " means a Previous drug Next that is produced or distributed pursuant to:

(1) an original, new Previous drug Next application approved under United States Code, title 21, section 355(c), except for a generic Previous drug Next as defined under Code of Federal Regulations, title 42, section 447.502; or

(2) a biologics license application approved under United States Code, title 45, section 262(a)(c).

(d) "Commissioner" means the commissioner of health.

(e) "Generic Previous drug Next " means a Previous drug Next that is marketed or distributed pursuant to:

(1) an abbreviated new Previous drug Next application approved under United States Code, title 21, section 355(j);

(2) an authorized generic as defined under Code of Federal Regulations, title 45, section 447.502; or

(3) a Previous drug Next that entered the market the year before 1962 and was not originally marketed under a new Previous drug Next application.

(f) "Manufacturer" means a Previous drug Next manufacturer licensed under section 151.252.

(g) "New Previous prescription Next Previous drug Next " or "new Previous drug Next " means a Previous prescription Next Previous drug Next approved for marketing by the United States Food and Previous Drug Next Administration for which no previous wholesale acquisition cost has been established for comparison.

(h) "Patient assistance program" means a program that a manufacturer offers to the public in which a consumer may reduce the consumer's out-of-pocket costs for Previous prescription Next drugs by using coupons, discount cards, prepaid gift cards, manufacturer debit cards, or by other means.

(i) " Previous Prescription Next Previous drug Next " or " Previous drug Next " has the meaning provided in section 151.441, subdivision 8.

(j) " Previous Price Next " means the wholesale acquisition cost as defined in United States Code, title 42, section 1395w-3a(c)(6)(B).

Subd. 3. Previous Prescription Next Previous drug Next Previous price Next increases reporting.

(a) Beginning January 1, 2022, a Previous drug Next manufacturer must submit to the commissioner the information described in paragraph (b) for each Previous prescription Next Previous drug Next for which the Previous price Next was $100 or greater for a 30-day supply or for a course of treatment lasting less than 30 days and:

(1) for brand name drugs where there is an increase of ten percent or greater in the Previous price Next over the previous 12-month period or an increase of 16 percent or greater in the Previous price Next over the previous 24-month period; and

(2) for generic drugs where there is an increase of 50 percent or greater in the Previous price Next over the previous 12-month period.

(b) For each of the drugs described in paragraph (a), the manufacturer shall submit to the commissioner no later than 60 days after the Previous price Next increase goes into effect, in the form and manner prescribed by the commissioner, the following information, if applicable:

(1) the name and Previous price Next of the Previous drug Next and the net increase, expressed as a percentage;

(2) the factors that contributed to the Previous price Next increase;

(3) the name of any generic version of the Previous prescription Next Previous drug Next available on the market;

(4) the introductory Previous price Next of the Previous prescription Next Previous drug Next when it was approved for marketing by the Food and Previous Drug Next Administration and the net yearly increase, by calendar year, in the Previous price Next of the Previous prescription Next Previous drug Next during the previous five years;

(5) the direct costs incurred by the manufacturer that are associated with the Previous prescription Next Previous drug Next , listed separately:

(i) to manufacture the Previous prescription Next Previous drug Next ;

(ii) to market the Previous prescription Next Previous drug Next , including advertising costs; and

(iii) to distribute the Previous prescription Next Previous drug Next ;

(6) the total sales revenue for the Previous prescription Next Previous drug Next during the previous 12-month period;

(7) the manufacturer's net profit attributable to the Previous prescription Next Previous drug Next during the previous 12-month period;

(8) the total amount of financial assistance the manufacturer has provided through patient Previous prescription Next assistance programs, if applicable;

(9) any agreement between a manufacturer and another entity contingent upon any delay in offering to market a generic version of the Previous prescription Next Previous drug Next ;

(10) the patent expiration date of the Previous prescription Next Previous drug Next if it is under patent;

(11) the name and location of the company that manufactured the Previous drug Next ; and

(12) if a brand name Previous prescription Next Previous drug Next , the ten highest prices paid for the Previous prescription Next Previous drug Next during the previous calendar year in any country other than the United States.

(c) The manufacturer may submit any documentation necessary to support the information reported under this subdivision.

Subd. 4.New Previous prescription Next Previous drug Next Previous price Next reporting.

(a) Beginning January 1, 2022, no later than 60 days after a manufacturer introduces a new Previous prescription Next Previous drug Next for sale in the United States that is a new brand name Previous drug Next with a Previous price Next that is greater than the tier threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program for a 30-day supply or a new generic or biosimilar Previous drug Next with a Previous price Next that is greater than the tier threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program for a 30-day supply and is not at least 15 percent lower than the referenced brand name Previous drug Next when the generic or biosimilar Previous drug Next is launched, the manufacturer must submit to the commissioner, in the form and manner prescribed by the commissioner, the following information, if applicable:

(1) the Previous price Next of the Previous prescription Next Previous drug Next ;

(2) whether the Food and Previous Drug Next Administration granted the new Previous prescription Next Previous drug Next a breakthrough therapy designation or a priority review;

(3) the direct costs incurred by the manufacturer that are associated with the Previous prescription Next Previous drug Next , listed separately:

(i) to manufacture the Previous prescription Next Previous drug Next ;

(ii) to market the Previous prescription Next Previous drug Next , including advertising costs; and

(iii) to distribute the Previous prescription Next Previous drug Next ; and

(4) the patent expiration date of the Previous drug Next if it is under patent.

(b) The manufacturer may submit documentation necessary to support the information reported under this subdivision.

Subd. 5.Newly acquired Previous prescription Next Previous drug Next Previous price Next reporting.

(a) Beginning January 1, 2022, the acquiring Previous drug Next manufacturer must submit to the commissioner the information described in paragraph (b) for each newly acquired Previous prescription Next Previous drug Next for which the Previous price Next was $100 or greater for a 30-day supply or for a course of treatment lasting less than 30 days and:

(1) for a newly acquired brand name Previous drug Next where there is an increase of ten percent or greater in the Previous price Next over the previous 12-month period or an increase of 16 percent or greater in Previous price Next over the previous 24-month period; and

(2) for a newly acquired generic Previous drug Next where there is an increase of 50 percent or greater in the Previous price Next over the previous 12-month period.

(b) For each of the drugs described in paragraph (a), the acquiring manufacturer shall submit to the commissioner no later than 60 days after the acquiring manufacturer begins to sell the newly acquired Previous drug Next , in the form and manner prescribed by the commissioner, the following information, if applicable:

(1) the Previous price Next of the Previous prescription Next Previous drug Next at the time of acquisition and in the calendar year prior to acquisition;

(2) the name of the company from which the Previous prescription Next Previous drug Next was acquired, the date acquired, and the purchase Previous price Next ;

(3) the year the Previous prescription Next Previous drug Next was introduced to market and the Previous price Next of the Previous prescription Next Previous drug Next at the time of introduction;

(4) the Previous price Next of the Previous prescription Next Previous drug Next for the previous five years;

(5) any agreement between a manufacturer and another entity contingent upon any delay in offering to market a generic version of the manufacturer's Previous drug Next ; and

(6) the patent expiration date of the Previous drug Next if it is under patent.

(c) The manufacturer may submit any documentation necessary to support the information reported under this subdivision.

Subd. 6.Public posting of Previous prescription Next Previous drug Next Previous price Next information.

(a) The commissioner shall post on the department's website, or may contract with a private entity or consortium that satisfies the standards of section 62U.04, subdivision 6, to meet this requirement, the following information:

(1) a list of the Previous prescription Next drugs reported under subdivisions 3, 4, and 5, and the manufacturers of those Previous prescription Next drugs; and

(2) information reported to the commissioner under subdivisions 3, 4, and 5.

(b) The information must be published in an easy-to-read format and in a manner that identifies the information that is disclosed on a per-drug basis and must not be aggregated in a manner that prevents the identification of the Previous prescription Next Previous drug Next .

(c) The commissioner shall not post to the department's website or a private entity contracting with the commissioner shall not post any information described in this section if the information is not public data under section 13.02, subdivision 8a; or is trade secret information under section 13.37, subdivision 1, paragraph (b); or is trade secret information pursuant to the Defend Trade Secrets Previous Act Next of 2016, United States Code, title 18, section 1836, as amended. If a manufacturer believes information should be withheld from public disclosure pursuant to this paragraph, the manufacturer must clearly and specifically identify that information and describe the legal basis in writing when the manufacturer submits the information under this section. If the commissioner disagrees with the manufacturer's request to withhold information from public disclosure, the commissioner shall provide the manufacturer written notice that the information will be publicly posted 30 days after the date of the notice.

(d) If the commissioner withholds any information from public disclosure pursuant to this subdivision, the commissioner shall post to the department's website a report describing the nature of the information and the commissioner's basis for withholding the information from disclosure.

(e) To the extent the information required to be posted under this subdivision is collected and made available to the public by another state, by the University of Minnesota, or through an online Previous drug Next pricing reference and analytical tool, the commissioner may reference the availability of this Previous drug Next Previous price Next data from another source including, within existing appropriations, creating the ability of the public to access the data from the source for purposes of meeting the reporting requirements of this subdivision.

Subd. 7.Consultation.

(a) The commissioner may consult with a private entity or consortium that satisfies the standards of section 62U.04, subdivision 6, the University of Minnesota, or the commissioner of commerce, as appropriate, in issuing the form and format of the information reported under this section; in posting information pursuant to subdivision 6; and in taking any other action for the purpose of implementing this section.

(b) The commissioner may consult with representatives of the manufacturers to establish a standard format for reporting information under this section and may use existing reporting methodologies to establish a standard format to minimize administrative burdens to the state and manufacturers.

Subd. 8.Enforcement and penalties.

(a) A manufacturer may be subject to a civil penalty, as provided in paragraph (b), for:

(1) failing to submit timely reports or notices as required by this section;

(2) failing to provide information required under this section; or

(3) providing inaccurate or incomplete information under this section.

(b) The commissioner shall adopt a schedule of civil penalties, not to exceed $10,000 per day of violation, based on the severity of each violation.

(c) The commissioner shall impose civil penalties under this section as provided in section 144.99, subdivision 4.

(d) The commissioner may remit or mitigate civil penalties under this section upon terms and conditions the commissioner considers proper and consistent with public health and safety.

(e) Civil penalties collected under this section shall be deposited in the health care access fund.

Subd. 9.Legislative report.

(a) No later than May 15, 2022, and by January 15 of each year thereafter, the commissioner shall report to the chairs and ranking minority members of the legislative committees with jurisdiction over commerce and health and human services policy and finance on the implementation of this section, including but not limited to the effectiveness in addressing the following goals:

(1) promoting Previous transparency in pharmaceutical pricing for the state and other payers;

(2) enhancing the understanding on pharmaceutical spending trends; and

(3) assisting the state and other payers in the management of pharmaceutical costs.

(b) The report must include a summary of the information submitted to the commissioner under subdivisions 3, 4, and 5.

History:

2020 c 78 s 1; 2021 c 30 art 3 s 5-9