A bill for an act
relating to health; requiring manufacturers to report and maintain prescription drug
prices; requiring the filing of health plan prescription drug formularies; health care
coverage; prohibiting health carriers from denying or limiting coverage due to
lack of prior authorization; establishing requirements for a prescription benefit
tool; requiring prescription drug benefit transparency and disclosure; amending
Minnesota Statutes 2020, sections 62A.02, subdivision 1; 62J.497, subdivisions
1, 3; 62J.84, subdivisions 2, 6, 7, 8, 9; 151.071, subdivision 2; proposing coding
for new law in Minnesota Statutes, chapters 62A; 62J; 62Q; repealing Minnesota
Statutes 2020, section 62D.12, subdivision 19.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

ARTICLE 1

REPORTING AND MAINTAINING PRESCRIPTION DRUG PRICES

Section 1.

Minnesota Statutes 2020, section 62A.02, subdivision 1, is amended to read:


Subdivision 1.

Filing.

For purposes of this section, "health plan" means a health plan
as defined in section 62A.011 or a policy of accident and sickness insurance as defined in
section 62A.01. No health plan shall be issued or delivered to any person in this state, nor
shall any application, rider, or endorsement be used in connection with the health plan, until
a copy of its form and of the classification of risks and the premium rates pertaining to the
form have been filed with the commissioner. new text beginThe filing must include the health plan's
prescription drug formulary.
new text endThe filing for nongroup health plan forms shall include a
statement of actuarial reasons and data to support the rate. For health benefit plans as defined
in section 62L.02, and for health plans to be issued to individuals, the health carrier shall
file with the commissioner the information required in section 62L.08, subdivision 8. For
group health plans for which approval is sought for sales only outside of the small employer
market as defined in section 62L.02, this section applies only to policies or contracts of
accident and sickness insurance. All forms intended for issuance in the individual or small
employer market must be accompanied by a statement as to the expected loss ratio for the
form. Premium rates and forms relating to specific insureds or proposed insureds, whether
individuals or groups, need not be filed, unless requested by the commissioner.

Sec. 2.

Minnesota Statutes 2020, section 62J.84, subdivision 2, is amended to read:


Subd. 2.

Definitions.

(a) For purposes of this sectionnew text begin and section 62J.841new text end, the terms
defined in this subdivision have the meanings given.

(b) "Biosimilar" means a drug 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 drug" means a drug that is produced or distributed pursuant to:

(1) an original, new drug application approved under United States Code, title 21, section
355(c), except for a generic drug 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 drug" means a drug that is marketed or distributed pursuant to:

(1) an abbreviated new drug 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 drug that entered the market the year before 1962 and was not originally marketed
under a new drug application.

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

(g) "New prescription drug" or "new drug" means a prescription drug approved for
marketing by the United States Food and Drug 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 prescription drugs
by using coupons, discount cards, prepaid gift cards, manufacturer debit cards, or by other
means.

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

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

Sec. 3.

Minnesota Statutes 2020, section 62J.84, subdivision 6, is amended to read:


Subd. 6.

Public posting of prescription drug price 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 prescription drugs reported under subdivisions 3, 4, and 5, and the
manufacturers of those prescription drugs; deleted text beginand
deleted text end

(2) information reported to the commissioner under subdivisions 3, 4, and 5new text begin; and
new text end

new text begin (3) information reported to the commissioner under section 62J.841, subdivision 2new text end.

(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 prescription drug.

(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 new text beginsubject to section
62J.841, subdivision 2, paragraph (e),
new text endis trade secret information under section 13.37,
subdivision 1
, paragraph (b); or new text beginsubject to section 62J.841, subdivision 2, paragraph (e), new text endis
trade secret information pursuant to the Defend Trade Secrets Act 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.

Sec. 4.

Minnesota Statutes 2020, section 62J.84, subdivision 7, is amended to read:


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 sectionnew text begin and section 62J.841new text end; in posting information
pursuant to subdivision 6; and in taking any other action for the purpose of implementing
this sectionnew text begin and section 62J.841new text end.

(b) The commissioner may consult with representatives of the manufacturers to establish
a standard format for reporting information under this section new text beginand section 62J.841 new text endand may
use existing reporting methodologies to establish a standard format to minimize
administrative burdens to the state and manufacturers.

Sec. 5.

Minnesota Statutes 2020, section 62J.84, subdivision 8, is amended to read:


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 sectionnew text begin and section
62J.841
new text end;

(2) failing to provide information required under this sectionnew text begin and section 62J.841new text end; deleted text beginor
deleted text end

(3) providing inaccurate or incomplete information under this sectionnew text begin and section 62J.841;
or
new text end

new text begin (4) failing to comply with section 62J.481, subdivisions 2, paragraph (e), and 4new text end.

(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 new text beginand section 62J.841
new text end as provided in section 144.99, subdivision 4.

(d) The commissioner may remit or mitigate civil penalties under this section new text beginand section
62J.481
new text endupon terms and conditions the commissioner considers proper and consistent with
public health and safety.

(e) Civil penalties collected under this section new text beginand section 62J.841 new text endshall be deposited in
the health care access fund.

Sec. 6.

Minnesota Statutes 2020, section 62J.84, subdivision 9, is amended to read:


Subd. 9.

Legislative report.

(a) No later than January 15 of each year, beginning January
15, 2022, 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 sectionnew text begin and section 62J.841new text end, including but
not limited to the effectiveness in addressing the following goals:

(1) promoting transparency in pharmaceutical pricing for the statenew text begin, health carriers,new text end and
other payers;

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

(3) assisting the statenew text begin, health carriers,new text end