SF 1098

1st Engrossment - 91st Legislature (2019 - 2020) Posted on 02/19/2020 05:01pm

A bill for an act
relating to health; establishing the Prescription Drug Price Transparency Act;
requiring rebates to be remitted to health plan companies to reduce premiums;
requiring health plan companies to report on the cost of the most expensive
prescription drugs and their relation to premium rates; authorizing pharmacists to
dispense certain prescription drugs in emergency situations; requiring the Board
of Pharmacy to provide information on its website regarding possible resources
for consumers to access lower cost prescription drugs; requiring a report; amending
Minnesota Statutes 2018, sections 62K.07; 151.01, subdivision 23; 151.06, by
adding a subdivision; 151.211, subdivision 2, by adding a subdivision; proposing
coding for new law in Minnesota Statutes, chapters 62J; 62Q; 214.

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

Section 1.

new text begin [62J.84] PRESCRIPTION DRUG PRICE TRANSPARENCY.
new text end

new text begin Subdivision 1. new text end

new text begin Short title. new text end

new text begin Sections 62J.84 and 62J.85 may be cited as the "Prescription
Drug Price Transparency Act."
new text end

new text begin Subd. 2. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section and section 62J.85, the terms
defined in this subdivision have the meanings given.
new text end

new text begin (b) "Aggregate amount of rebate" means all pharmacy rebates received by a health plan
company for individual and small group health plans used to reduce health insurance
premiums for individual and small group health plans.
new text end

new text begin (c) "Commissioner" means the commissioner of health.
new text end

new text begin (d) "Manufacturer" means a drug manufacturer licensed under section 151.252.
new text end

new text begin (e) "New prescription 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.
new text end

new text begin (f) "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.
new text end

new text begin (g) "Prescription drug" or "drug" has the meaning provided in section 151.44, paragraph
(d).
new text end

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

new text begin Subd. 3. new text end

new text begin Prescription drug price increases reporting. new text end

new text begin (a) Beginning July 1, 2020, a
drug manufacturer must submit to the commissioner the information described in paragraph
(b) for each prescription drug for which:
new text end

new text begin (1) the price was $100 or greater for a one-month supply or for a course of treatment
lasting less than one month; and
new text end

new text begin (2) there was a net increase of ten percent or greater in the price over the previous
12-month period.
new text end

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

new text begin (1) the name and price of the drug and the net increase, expressed as a percentage;
new text end

new text begin (2) the factors that contributed to the price increase;
new text end

new text begin (3) the name of any generic version of the prescription drug available on the market;
new text end

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

new text begin (5) the direct costs incurred by the manufacturer that are associated with the prescription
drug, listed separately:
new text end

new text begin (i) to manufacture the prescription drug;
new text end

new text begin (ii) to market the prescription drug, including advertising costs;
new text end

new text begin (iii) to research and develop the prescription drug; and
new text end

new text begin (iv) to distribute the prescription drug;
new text end

new text begin (6) the total sales revenue for the prescription drug during the previous 12-month period;
new text end

new text begin (7) the manufacturer's net profit attributable to the prescription drug during the previous
12-month period;
new text end

new text begin (8) the total amount of financial assistance the manufacturer has provided through patient
prescription assistance programs, if applicable;
new text end

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

new text begin (10) the patent expiration date of the prescription drug if it is under patent; and
new text end

new text begin (11) the ten highest prices paid for the prescription drug during the previous calendar
year in any country other than the United States.
new text end

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

new text begin Subd. 4. new text end

new text begin New prescription drug price reporting. new text end

new text begin (a) Beginning March 15, 2020, no
later than 60 days after a manufacturer introduces a new prescription drug for sale in the
United States that is a new brand name drug with a price that is greater than $500 for a
30-day supply or a new generic drug with a price that is greater than $200 for a 30-day
supply, the manufacturer must submit to the commissioner, in the form and manner prescribed
by the commissioner, the following information:
new text end

new text begin (1) the price of the prescription drug;
new text end

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

new text begin (3) the direct costs incurred by the manufacturer that are associated with the prescription
drug, listed separately:
new text end

new text begin (i) to manufacture the prescription drug;
new text end

new text begin (ii) to market the prescription drug, including advertising costs; and
new text end

new text begin (iii) to research and develop the prescription drug, if the prescription drug was developed
by the manufacturer;
new text end

new text begin (iv) other administrative costs; and
new text end

new text begin (4) the patent expiration date of the drug if it is under patent.
new text end

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

new text begin Subd. 5. new text end

new text begin Newly acquired prescription drug price reporting. new text end

new text begin (a) Beginning July 1,
2020, for every newly acquired prescription drug for which the price increases by more
than $100 from the price before the acquisition and the price after the acquisition, the
acquiring manufacturer must submit to the commissioner at least 60 days after the acquiring
manufacturer begins to sell the newly acquired prescription drug, in the form and manner
prescribed by the commissioner, the following information:
new text end

new text begin (1) the price of the prescription drug at the time of acquisition and in the calendar year
prior to acquisition;
new text end

new text begin (2) the name of the company from which the prescription drug was acquired, the date
acquired, and the purchase price;
new text end

new text begin (3) the year the prescription drug was introduced to market and the price of the
prescription drug at the time of introduction;
new text end

new text begin (4) the price of the prescription drug for the previous five years;
new text end

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

new text begin (6) the patent expiration date of the drug if it is under patent.
new text end

new text begin (b) The manufacturer may submit any documentation necessary to support the information
reported under this subdivision.
new text end

new text begin Subd. 6. new text end

new text begin Public posting of prescription drug price information. new text end

new text begin (a) Except as provided
in paragraph (c), 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:
new text end

new text begin (1) a list of the prescription drugs reported under subdivisions 3, 4, and 5, and the
manufacturers of those prescription drugs; and
new text end

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

new text begin (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.
new text end

new text begin (c) The commissioner shall not post to the department's website any information described
in this section if:
new text end

new text begin (1) 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
new text end

new text begin (2) the commissioner determines that public interest does not require the disclosure of
the information because the information is unrelated to the price of a prescription drug.
new text end

new text begin (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.
new text end

new text begin Subd. 7. new text end

new text begin Consultation. new text end

new text begin (a) The commissioner may consult with a private entity or
consortium that satisfies the standards of section 62U.04, subdivision 6, and 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.
new text end

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

new text begin Subd. 8. new text end

new text begin Enforcement and penalties. new text end

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

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

new text begin (2) failing to provide information required under this section; or
new text end

new text begin (3) providing inaccurate or incomplete information under this section.
new text end

new text begin (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.
new text end

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

new text begin (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.
new text end

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

new text begin Subd. 9. new text end

new text begin Legislative report. new text end

new text begin (a) No later than January 15 of each year, beginning January
15, 2021, 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:
new text end

new text begin (1) promoting transparency in pharmaceutical pricing for the state and other payers;
new text end

new text begin (2) enhancing the understanding on pharmaceutical spending trends; and
new text end

new text begin (3) assisting the state and other payers in the management of pharmaceutical costs.
new text end

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

new text begin Subd. 10. new text end

new text begin Nonseverability. new text end

new text begin If any particular section, subdivision, or provision of this
section or section 62J.85, or the application thereof to any person or circumstance, is enjoined
in full or in part by a court or is held invalid, the remainder of this section and section 62J.85
and the application of any subdivision or provision of this section and section 62J.85 to
other persons or circumstances shall also be invalid and not in effect.
new text end

Sec. 2.

new text begin [62J.85] USE OF COMPENSATION TO LOWER PREMIUMS.
new text end

new text begin (a) All compensation remitted by or on behalf of a drug manufacturer that is received
by a pharmacy benefit manager for actual or estimated drug utilization by enrollees of the
pharmacy benefit manager's health plan company client must be remitted to and retained
by the health plan company and used by the health plan company to reduce premiums.
new text end

new text begin (b) By March 1 of each year, beginning March 1, 2022, each health plan company shall
file with the commissioner in a manner and form prescribed by the commissioner:
new text end

new text begin (1) the aggregate amount of rebates that the health plan company received directly from
drug manufacturers or was remitted to the health plan company from pharmacy benefit
managers; and
new text end

new text begin (2) how the health plan company has complied with paragraph (a) for the previous plan
year.
new text end

new text begin (c) For purposes of this section, "compensation" means direct or indirect financial benefit,
including rebates, discounts, credits, fees, or grants.
new text end

Sec. 3.

Minnesota Statutes 2018, section 62K.07, is amended to read:

62K.07 INFORMATION DISCLOSURES.

new text begin Subdivision 1. new text end

new text begin In general. new text end

(a) A health carrier offering individual or small group health
plans must submit the following information in a format determined by the commissioner
of commerce:

(1) claims payment policies and practices;

(2) periodic financial disclosures;

(3) data on enrollment;

(4) data on disenrollment;

(5) data on the number of claims that are denied;

(6) data on rating practices;

(7) information on cost-sharing and payments with respect to out-of-network coverage;
and

(8) other information required by the secretary of the United States Department of Health
and Human Services under the Affordable Care Act.

(b) A health carrier offering an individual or small group health plan must comply with
all information disclosure requirements of all applicable state and federal law, including
the Affordable Care Act.

(c) Except for qualified health plans sold on MNsure, information reported under
paragraph (a), clauses (3) and (4), is nonpublic data as defined under section 13.02,
subdivision 9. Information reported under paragraph (a), clauses (1) through (8), must be
reported by MNsure for qualified health plans sold through MNsure.

new text begin Subd. 2. new text end

new text begin Prescription drug costs. new text end

new text begin (a) Each health carrier that offers a prescription drug
benefit in its individual health plans or small group health plans shall include in the applicable
rate filing required under section 62A.02 the following information about covered prescription
drugs:
new text end

new text begin (1) the 25 most frequently prescribed drugs in the previous plan year;
new text end

new text begin (2) the 25 most costly prescription drugs as a portion of the individual health plan's or
small group health plan's total annual expenditures in the previous plan year;
new text end

new text begin (3) the 25 prescription drugs that have caused the greatest increase in total individual
health plan or small group health plan spending in the previous plan year; and
new text end

new text begin (4) the projected impact of the cost of prescription drugs on premium rates.
new text end

new text begin (b) The commissioner of commerce, in consultation with the commissioner of health,
shall release a summary of the information reported in paragraph (a) at the same time as
the information required under section 62A.02, subdivision 2, paragraph (c).
new text end

new text begin Subd. 3. new text end

new text begin Enforcement. new text end

deleted text begin (d) deleted text end The commissioner of commerce shall enforce this section.

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective for individual health plans and small
group health plans offered, issued, sold, or renewed on or after January 1, 2021.
new text end

Sec. 4.

new text begin [62Q.528] DRUG COVERAGE IN EMERGENCY SITUATIONS.
new text end

new text begin A health plan that provides prescription drug coverage must provide coverage for a
prescription drug dispensed by a pharmacist under section 151.211, subdivision 3, under
the terms of coverage that would apply had the prescription drug been dispensed according
to a prescription.
new text end

Sec. 5.

Minnesota Statutes 2018, section 151.01, subdivision 23, is amended to read:

Subd. 23.

Practitioner.

"Practitioner" means a licensed doctor of medicine, licensed
doctor of osteopathic medicine duly licensed to practice medicine, licensed doctor of
dentistry, licensed doctor of optometry, licensed podiatrist, licensed veterinarian, or licensed
advanced practice registered nurse. For purposes of sections 151.15, subdivision 4; new text begin 151.211,
subdivision 3; new text end 151.252, subdivision 3; 151.37, subdivision 2, paragraphs (b), (e), and (f);
and 151.461, "practitioner" also means a physician assistant authorized to prescribe, dispense,
and administer under chapter 147A. For purposes of sections 151.15, subdivision 4; new text begin 151.211,
subdivision 3; new text end 151.252, subdivision 3; 151.37, subdivision 2, paragraph (b); and 151.461,
"practitioner" also means a dental therapist authorized to dispense and administer under
chapter 150A.

Sec. 6.

Minnesota Statutes 2018, section 151.06, is amended by adding a subdivision to
read:

new text begin Subd. 6. new text end

new text begin Information provision; sources of lower cost prescription drugs. new text end

new text begin (a) The
board shall publish a page on its website that provides regularly updated information
concerning:
new text end

new text begin (1) patient assistance programs offered by drug manufacturers, including information
on how to access the programs;
new text end

new text begin (2) the prescription drug assistance program established by the Minnesota Board of
Aging under section 256.975, subdivision 9;
new text end

new text begin (3) the websites through which individuals can access information concerning eligibility
for and enrollment in Medicare, medical assistance, MinnesotaCare, and other
government-funded programs that help pay for the cost of health care;
new text end

new text begin (4) availability of providers that are authorized to participate under section 340b of the
federal Public Health Services Act, United States Code, title 42, section 256b;
new text end

new text begin (5) having a discussion with the pharmacist or the consumer's health care provider about
alternatives to a prescribed drug, including a lower cost or generic drug if the drug prescribed
is too costly for the consumer; and
new text end

new text begin (6) any other resource that the board deems useful to individuals who are attempting to
purchase prescription drugs at lower costs.
new text end

new text begin (b) The board must prepare educational materials, including brochures and posters, based
on the information it provides on its website under paragraph (a). The materials must be in
a form that can be downloaded from the board's website and used for patient education by
pharmacists and by health care practitioners who are licensed to prescribe. The board is not
required to provide printed copies of these materials.
new text end

new text begin (c) The board shall require pharmacists and pharmacies to make available to patients
information on sources of lower cost prescription drugs, including information on the
availability of the website established under paragraph (a).
new text end

Sec. 7.

Minnesota Statutes 2018, section 151.211, subdivision 2, is amended to read:

Subd. 2.

Refill requirements.

new text begin Except as provided in subdivision 3, new text end a prescription drug
order may be refilled only with the written, electronic, or verbal consent of the prescriber
and in accordance with the requirements of this chapter, the rules of the board, and where
applicable, section 152.11. The date of such refill must be recorded and initialed upon the
original prescription drug order, or within the electronically maintained record of the original
prescription drug order, by the pharmacist, pharmacist intern, or practitioner who refills the
prescription.

Sec. 8.

Minnesota Statutes 2018, section 151.211, is amended by adding a subdivision to
read:

new text begin Subd. 3. new text end

new text begin Emergency prescription refills. new text end

new text begin (a) A pharmacist may, using sound professional
judgment and in accordance with accepted standards of practice, dispense a legend drug
without a current prescription drug order from a licensed practitioner if all of the following
conditions are met:
new text end

new text begin (1) the patient has been compliant with taking the medication and has consistently had
the drug filled or refilled as demonstrated by records maintained by the pharmacy;
new text end

new text begin (2) the pharmacy from which the legend drug is dispensed has record of a prescription
drug order for the drug in the name of the patient who is requesting it, but the prescription
drug order does not provide for a refill, or the time during which the refills were valid has
elapsed;
new text end

new text begin (3) the pharmacist has tried but is unable to contact the practitioner who issued the
prescription drug order, or another practitioner responsible for the patient's care, to obtain
authorization to refill the prescription;
new text end

new text begin (4) the drug is essential to sustain the life of the patient or to continue therapy for a
chronic condition;
new text end

new text begin (5) failure to dispense the drug to the patient would result in harm to the health of the
patient; and
new text end

new text begin (6) the drug is not a controlled substance listed in section 152.02, subdivisions 3 to 6,
except for a controlled substance that has been specifically prescribed to treat a seizure
disorder, in which case the pharmacist may dispense up to a 72-hour supply.
new text end

new text begin (b) If the conditions in paragraph (a) are met, the amount of the drug dispensed by the
pharmacist to the patient must not exceed a 30-day supply, or the quantity originally
prescribed, whichever is less, except as provided for controlled substances in paragraph (a),
clause (6). If the standard unit of dispensing for the drug exceeds a 30-day supply, the
amount of the drug dispensed or sold must not exceed the standard unit of dispensing.
new text end

new text begin (c) A pharmacist shall not dispense or sell the same drug to the same patient, as provided
in this section, more than one time in any 12-month period.
new text end

new text begin (d) A pharmacist must notify the practitioner who issued the prescription drug order not
later than 72 hours after the drug is sold or dispensed. The pharmacist must request and
receive authorization before any additional refills may be dispensed. If the practitioner
declines to provide authorization for additional refills, the pharmacist must inform the patient
of that fact.
new text end

new text begin (e) The record of a drug sold or dispensed under this section shall be maintained in the
same manner required for prescription drug orders under this section.
new text end

Sec. 9.

new text begin [214.122] INFORMATION PROVISION; PHARMACEUTICAL
ASSISTANCE PROGRAMS.
new text end

new text begin (a) The Board of Medical Practice and the Board of Nursing shall at least annually inform
licensees who are authorized to prescribe prescription drugs of the availability of the Board
of Pharmacy's website that contains information on resources and programs to assist patients
with the cost of prescription drugs. The boards shall provide licensees with the website
address established by the Board of Pharmacy under section 151.06, subdivision 6, and the
materials described under section 151.06, subdivision 6, paragraph (b).
new text end

new text begin (b) Licensees must make available to patients information on sources of lower cost
prescription drugs, including information on the availability of the website established by
the Board of Pharmacy under section 151.06, subdivision 6.
new text end