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HF 58

2nd Engrossment - 92nd Legislature (2021 - 2022) Posted on 03/15/2021 04:19pm

KEY: stricken = removed, old language.
underscored = added, new language.

Bill Text Versions

Engrossments
Introduction Posted on 01/11/2021
1st Engrossment Posted on 02/08/2021
2nd Engrossment Posted on 03/10/2021

Current Version - 2nd Engrossment

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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; 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 62J; 62Q.

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 151.252new text begin, but does
not include an entity required to be licensed under that section solely because the entity
repackages or relabels drugs
new text end.

(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 and other payers in the management of
pharmaceutical costsnew text begin and limiting formulary changes due to prescription drug cost increases
during a coverage year
new text end.

(b) The report must include a summary of the information submitted to the commissioner
under subdivisions 3, 4, and 5new text begin, and section 62J.841new text end.

Sec. 7.

new text begin [62J.841] REPORTING PRESCRIPTION DRUG PRICES; FORMULARY
DEVELOPMENT AND PRICE STABILITY.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the terms in this subdivision
have the meanings given them.
new text end

new text begin (b) "Average wholesale price" means the customary reference price for sales by a drug
wholesaler to a retail pharmacy, as established and published by the manufacturer.
new text end

new text begin (c) "National drug code" means the numerical code maintained by the United States
Food and Drug Administration and includes the label code, product code, and package code.
new text end

new text begin (d) "Wholesale acquisition cost" has the meaning given in United States Code, title 42,
section 1395w-3a(c)(6)(B).
new text end

new text begin (e) "Unit" has the meaning given in United States Code, title 42, section 1395w-3a(b)(2).
new text end

new text begin Subd. 2. new text end

new text begin Price reporting. new text end

new text begin (a) Beginning March 31, 2022, and by March 31 each year
thereafter, a manufacturer must report to the commissioner the information in paragraph
(b) for every drug with a wholesale acquisition cost of $100 or more for a 30-day supply
or for a course of treatment lasting less than 30 days, as applicable to the next calendar year.
new text end

new text begin (b) A manufacturer shall report a drug's:
new text end

new text begin (1) national drug code, labeler code, and the manufacturer name associated with the
labeler code;
new text end

new text begin (2) brand name, if applicable;
new text end

new text begin (3) generic name, if applicable;
new text end

new text begin (4) wholesale acquisition cost for one unit;
new text end

new text begin (5) measure that constitutes a wholesale acquisition cost unit;
new text end

new text begin (6) average wholesale price; and
new text end

new text begin (7) status as brand name or generic.
new text end

new text begin (c) The effective date of the information described in paragraph (b) must be included in
the report to the commissioner.
new text end

new text begin (d) A manufacturer must report the information described in this subdivision in the form
and manner specified by the commissioner.
new text end

new text begin (e) Information reported under this subdivision is classified as public data not on
individuals, as defined in section 13.02, subdivision 14, and must not be classified by the
manufacturer as trade secret information, as defined in section 13.37, subdivision 1, paragraph
(b).
new text end

new text begin (f) A manufacturer's failure to report the information required by this subdivision is
grounds for disciplinary action under section 151.071, subdivision 2.
new text end

new text begin Subd. 3. new text end

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

new text begin By May 1 of each
year, beginning May 1, 2022, the commissioner must post the information reported under
subdivision 2 on the department's website, as required by section 62J.84, subdivision 6.
new text end

new text begin Subd. 4. new text end

new text begin Price change. new text end

new text begin (a) If a drug subject to price reporting under subdivision 2 is
included in the formulary of a health plan submitted to and approved by the commissioner
of commerce for the next calendar year under section 62A.02, subdivision 1, the manufacturer
must not increase the wholesale acquisition cost of the drug for the next calendar year.
new text end

new text begin (b) A manufacturer's failure to meet the requirements of paragraph (a) is grounds for
disciplinary action under section 151.071, subdivision 2.
new text end

Sec. 8.

Minnesota Statutes 2020, section 151.071, subdivision 2, is amended to read:


Subd. 2.

Grounds for disciplinary action.

The following conduct is prohibited and is
grounds for disciplinary action:

(1) failure to demonstrate the qualifications or satisfy the requirements for a license or
registration contained in this chapter or the rules of the board. The burden of proof is on
the applicant to demonstrate such qualifications or satisfaction of such requirements;

(2) obtaining a license by fraud or by misleading the board in any way during the
application process or obtaining a license by cheating, or attempting to subvert the licensing
examination process. Conduct that subverts or attempts to subvert the licensing examination
process includes, but is not limited to: (i) conduct that violates the security of the examination
materials, such as removing examination materials from the examination room or having
unauthorized possession of any portion of a future, current, or previously administered
licensing examination; (ii) conduct that violates the standard of test administration, such as
communicating with another examinee during administration of the examination, copying
another examinee's answers, permitting another examinee to copy one's answers, or
possessing unauthorized materials; or (iii) impersonating an examinee or permitting an
impersonator to take the examination on one's own behalf;

(3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a pharmacist
or pharmacy license, or applicant for a pharmacy technician or pharmacist intern registration,
conviction of a felony reasonably related to the practice of pharmacy. Conviction as used
in this subdivision includes a conviction of an offense that if committed in this state would
be deemed a felony without regard to its designation elsewhere, or a criminal proceeding
where a finding or verdict of guilt is made or returned but the adjudication of guilt is either
withheld or not entered thereon. The board may delay the issuance of a new license or
registration if the applicant has been charged with a felony until the matter has been
adjudicated;

(4) for a facility, other than a pharmacy, licensed or registered by the board, if an owner
or applicant is convicted of a felony reasonably related to the operation of the facility. The
board may delay the issuance of a new license or registration if the owner or applicant has
been charged with a felony until the matter has been adjudicated;

(5) for a controlled substance researcher, conviction of a felony reasonably related to
controlled substances or to the practice of the researcher's profession. The board may delay
the issuance of a registration if the applicant has been charged with a felony until the matter
has been adjudicated;

(6) disciplinary action taken by another state or by one of this state's health licensing
agencies:

(i) revocation, suspension, restriction, limitation, or other disciplinary action against a
license or registration in another state or jurisdiction, failure to report to the board that
charges or allegations regarding the person's license or registration have been brought in
another state or jurisdiction, or having been refused a license or registration by any other
state or jurisdiction. The board may delay the issuance of a new license or registration if an
investigation or disciplinary action is pending in another state or jurisdiction until the
investigation or action has been dismissed or otherwise resolved; and

(ii) revocation, suspension, restriction, limitation, or other disciplinary action against a
license or registration issued by another of this state's health licensing agencies, failure to
report to the board that charges regarding the person's license or registration have been
brought by another of this state's health licensing agencies, or having been refused a license
or registration by another of this state's health licensing agencies. The board may delay the
issuance of a new license or registration if a disciplinary action is pending before another
of this state's health licensing agencies until the action has been dismissed or otherwise
resolved;

(7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation of
any order of the board, of any of the provisions of this chapter or any rules of the board or
violation of any federal, state, or local law or rule reasonably pertaining to the practice of
pharmacy;

(8) for a facility, other than a pharmacy, licensed by the board, violations of any order
of the board, of any of the provisions of this chapter or the rules of the board or violation
of any federal, state, or local law relating to the operation of the facility;

(9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm the
public, or demonstrating a willful or careless disregard for the health, welfare, or safety of
a patient; or pharmacy practice that is professionally incompetent, in that it may create
unnecessary danger to any patient's life, health, or safety, in any of which cases, proof of
actual injury need not be established;

(10) aiding or abetting an unlicensed person in the practice of pharmacy, except that it
is not a violation of this clause for a pharmacist to supervise a properly registered pharmacy
technician or pharmacist intern if that person is performing duties allowed by this chapter
or the rules of the board;

(11) for an individual licensed or registered by the board, adjudication as mentally ill
or developmentally disabled, or as a chemically dependent person, a person dangerous to
the public, a sexually dangerous person, or a person who has a sexual psychopathic
personality, by a court of competent jurisdiction, within or without this state. Such
adjudication shall automatically suspend a license for the duration thereof unless the board
orders otherwise;

(12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as specified
in the board's rules. In the case of a pharmacy technician, engaging in conduct specified in
board rules that would be unprofessional if it were engaged in by a pharmacist or pharmacist
intern or performing duties specifically reserved for pharmacists under this chapter or the
rules of the board;

(13) for a pharmacy, operation of the pharmacy without a pharmacist present and on
duty except as allowed by a variance approved by the board;

(14) for a pharmacist, the inability to practice pharmacy with reasonable skill and safety
to patients by reason of illness, use of alcohol, drugs, narcotics, chemicals, or any other type
of material or as a result of any mental or physical condition, including deterioration through
the aging process or loss of motor skills. In the case of registered pharmacy technicians,
pharmacist interns, or controlled substance researchers, the inability to carry out duties
allowed under this chapter or the rules of the board with reasonable skill and safety to
patients by reason of illness, use of alcohol, drugs, narcotics, chemicals, or any other type
of material or as a result of any mental or physical condition, including deterioration through
the aging process or loss of motor skills;

(15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical gas
dispenser, or controlled substance researcher, revealing a privileged communication from
or relating to a patient except when otherwise required or permitted by law;

(16) for a pharmacist or pharmacy, improper management of patient records, including
failure to maintain adequate patient records, to comply with a patient's request made pursuant
to sections 144.291 to 144.298, or to furnish a patient record or report required by law;

(17) fee splitting, including without limitation:

(i) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate,
kickback, or other form of remuneration, directly or indirectly, for the referral of patients;

(ii) referring a patient to any health care provider as defined in sections 144.291 to
144.298 in which the licensee or registrant has a financial or economic interest as defined
in section 144.6521, subdivision 3, unless the licensee or registrant has disclosed the
licensee's or registrant's financial or economic interest in accordance with section 144.6521;
and

(iii) any arrangement through which a pharmacy, in which the prescribing practitioner
does not have a significant ownership interest, fills a prescription drug order and the
prescribing practitioner is involved in any manner, directly or indirectly, in setting the price
for the filled prescription that is charged to the patient, the patient's insurer or pharmacy
benefit manager, or other person paying for the prescription or, in the case of veterinary
patients, the price for the filled prescription that is charged to the client or other person
paying for the prescription, except that a veterinarian and a pharmacy may enter into such
an arrangement provided that the client or other person paying for the prescription is notified,
in writing and with each prescription dispensed, about the arrangement, unless such
arrangement involves pharmacy services provided for livestock, poultry, and agricultural
production systems, in which case client notification would not be required;

(18) engaging in abusive or fraudulent billing practices, including violations of the
federal Medicare and Medicaid laws or state medical assistance laws or rules;

(19) engaging in conduct with a patient that is sexual or may reasonably be interpreted
by the patient as sexual, or in any verbal behavior that is seductive or sexually demeaning
to a patient;

(20) failure to make reports as required by section 151.072 or to cooperate with an
investigation of the board as required by section 151.074;

(21) knowingly providing false or misleading information that is directly related to the
care of a patient unless done for an accepted therapeutic purpose such as the dispensing and
administration of a placebo;

(22) aiding suicide or aiding attempted suicide in violation of section 609.215 as
established by any of the following:

(i) a copy of the record of criminal conviction or plea of guilty for a felony in violation
of section 609.215, subdivision 1 or 2;

(ii) a copy of the record of a judgment of contempt of court for violating an injunction
issued under section 609.215, subdivision 4;

(iii) a copy of the record of a judgment assessing damages under section 609.215,
subdivision 5; or

(iv) a finding by the board that the person violated section 609.215, subdivision 1 or 2.
The board must investigate any complaint of a violation of section 609.215, subdivision 1
or 2;

(23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license. For
a pharmacist intern, pharmacy technician, or controlled substance researcher, performing
duties permitted to such individuals by this chapter or the rules of the board under a lapsed
or nonrenewed registration. For a facility required to be licensed under this chapter, operation
of the facility under a lapsed or nonrenewed license or registration; deleted text beginand
deleted text end

(24) for a pharmacist, pharmacist intern, or pharmacy technician, termination or discharge
from the health professionals services program for reasons other than the satisfactory
completion of the programnew text begin; and
new text end

new text begin (25) for a drug manufacturer, failure to comply with section 62J.841new text end.

ARTICLE 2

PRESCRIPTION DRUG BENEFIT TRANSPARENCY

Section 1.

Minnesota Statutes 2020, section 62J.497, subdivision 1, is amended to read:


Subdivision 1.

Definitions.

(a) For the purposes of this section, the following terms have
the meanings given.

(b) "Backward compatible" means that the newer version of a data transmission standard
would retain, at a minimum, the full functionality of the versions previously adopted, and
would permit the successful completion of the applicable transactions with entities that
continue to use the older versions.

(c) "Dispense" or "dispensing" has the meaning given in section 151.01, subdivision 30.
Dispensing does not include the direct administering of a controlled substance to a patient
by a licensed health care professional.

(d) "Dispenser" means a person authorized by law to dispense a controlled substance,
pursuant to a valid prescription.

(e) "Electronic media" has the meaning given under Code of Federal Regulations, title
45, part 160.103.

(f) "E-prescribing" means the transmission using electronic media of prescription or
prescription-related information between a prescriber, dispenser, pharmacy benefit manager,
or group purchaser, either directly or through an intermediary, including an e-prescribing
network. E-prescribing includes, but is not limited to, two-way transmissions between the
point of care and the dispenser and two-way transmissions related to eligibility, formulary,
and medication history information.

(g) "Electronic prescription drug program" means a program that provides for
e-prescribing.

(h) "Group purchaser" has the meaning given in section 62J.03, subdivision 6.

(i) "HL7 messages" means a standard approved by the standards development
organization known as Health Level Seven.

(j) "National Provider Identifier" or "NPI" means the identifier described under Code
of Federal Regulations, title 45, part 162.406.

(k) "NCPDP" means the National Council for Prescription Drug Programs, Inc.

(l) "NCPDP Formulary and Benefits Standard" means the National Council for
Prescription Drug Programs Formulary and Benefits Standard, Implementation Guide,
Version 1, Release 0, October 2005.

new text begin (m) "NCPDP Real-Time Prescription Benefit Standard" means the most recent National
Council for Prescription Drug Programs Real-Time Prescription Benefit Standard adopted
by the Centers for Medicare and Medicaid Services for e-prescribing under Medicare Part
D as required by section 1860D-4(e)(2) of the Social Security Act, and regulations adopted
under it.
new text end

deleted text begin (m)deleted text endnew text begin (n)new text end "NCPDP SCRIPT Standard" means the National Council for Prescription Drug
Programs Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide Version
8, Release 1 (Version 8.1), October 2005, or the most recent standard adopted by the Centers
for Medicare and Medicaid Services for e-prescribing under Medicare Part D as required
by section 1860D-4(e)(4)(D) of the Social Security Act, and regulations adopted under it.
The standards shall be implemented according to the Centers for Medicare and Medicaid
Services schedule for compliance. Subsequently released versions of the NCPDP SCRIPT
Standard may be used, provided that the new version of the standard is backward compatible
to the current version adopted by the Centers for Medicare and Medicaid Services.

deleted text begin (n)deleted text endnew text begin (o)new text end "Pharmacy" has the meaning given in section 151.01, subdivision 2.

new text begin (p) "Pharmacy benefit manager" has the meaning given in section 62W.02, subdivision
15.
new text end

deleted text begin (o)deleted text endnew text begin (q)new text end "Prescriber" means a licensed health care practitioner, other than a veterinarian,
as defined in section 151.01, subdivision 23.

deleted text begin (p)deleted text endnew text begin (r)new text end "Prescription-related information" means information regarding eligibility for
drug benefits, medication history, or related health or drug information.

deleted text begin (q)deleted text endnew text begin (s)new text end "Provider" or "health care provider" has the meaning given in section 62J.03,
subdivision 8.

new text begin (t) "Real-time prescription benefit tool" means a tool that is capable of being integrated
into a prescriber's e-prescribing system and that provides a prescriber with up-to-date and
patient-specific formulary and benefit information at the time the prescriber submits a
prescription.
new text end

Sec. 2.

Minnesota Statutes 2020, section 62J.497, subdivision 3, is amended to read:


Subd. 3.

Standards for electronic prescribing.

(a) Prescribers and dispensers must use
the NCPDP SCRIPT Standard for the communication of a prescription or prescription-related
information. The NCPDP SCRIPT Standard shall be used to conduct the following
transactions:

(1) get message transaction;

(2) status response transaction;

(3) error response transaction;

(4) new prescription transaction;

(5) prescription change request transaction;

(6) prescription change response transaction;

(7) refill prescription request transaction;

(8) refill prescription response transaction;

(9) verification transaction;

(10) password change transaction;

(11) cancel prescription request transaction; and

(12) cancel prescription response transaction.

(b) Providers, group purchasers, prescribers, and dispensers must use the NCPDP SCRIPT
Standard for communicating and transmitting medication history information.

(c) Providers, group purchasers, prescribers, and dispensers must use the NCPDP
Formulary and Benefits Standard for communicating and transmitting formulary and benefit
information.

(d) Providers, group purchasers, prescribers, and dispensers must use the national provider
identifier to identify a health care provider in e-prescribing or prescription-related transactions
when a health care provider's identifier is required.

(e) Providers, group purchasers, prescribers, and dispensers must communicate eligibility
information and conduct health care eligibility benefit inquiry and response transactions
according to the requirements of section 62J.536.

new text begin (f) Group purchasers and pharmacy benefit managers must use a real-time prescription
benefit tool that complies with the NCPDP Real-Time Prescription Benefit Standard and
that, at a minimum, notifies a prescriber:
new text end

new text begin (1) if a prescribed drug is covered by the patient's group purchaser or pharmacy benefit
manager;
new text end

new text begin (2) if a prescribed drug is included on the formulary or preferred drug list of the patient's
group purchaser or pharmacy benefit manager;
new text end

new text begin (3) of any patient cost-sharing for the prescribed drug;
new text end

new text begin (4) if prior authorization is required for the prescribed drug; and
new text end

new text begin (5) of a list of any available alternative drugs that are in the same class as the drug
originally prescribed and for which prior authorization is not required.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2022.
new text end

Sec. 3.

new text begin [62Q.83] PRESCRIPTION DRUG BENEFIT TRANSPARENCY AND
MANAGEMENT.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For purposes of this section, the following terms have
the meanings given them.
new text end

new text begin (b) "Drug" has the meaning given in section 151.01, subdivision 5.
new text end

new text begin (c) "Enrollee contract term" means the 12-month term during which benefits associated
with health plan company products are in effect. For managed care plans and county-based
purchasing plans under section 256B.69 and chapter 256L, it means a single calendar quarter.
new text end

new text begin (d) "Formulary" means a list of prescription drugs that has been developed by clinical
and pharmacy experts and that represents the health plan company's medically appropriate
and cost-effective prescription drugs approved for use.
new text end

new text begin (e) "Health plan company" has the meaning given in section 62Q.01, subdivision 4, and
includes an entity that performs pharmacy benefits management for the health plan company.
For purposes of this definition, "pharmacy benefits management" means the administration
or management of prescription drug benefits provided by the health plan company for the
benefit of the plan's enrollees and may include but is not limited to procurement of
prescription drugs, clinical formulary development and management services, claims
processing, and rebate contracting and administration.
new text end

new text begin (f) "Prescription" has the meaning given in section 151.01, subdivision 16a.
new text end

new text begin Subd. 2. new text end

new text begin Prescription drug benefit disclosure. new text end

new text begin (a) A health plan company that provides
prescription drug benefit coverage and uses a formulary must make the plan's formulary
and related benefit information available by electronic means and, upon request, in writing,
at least 30 days prior to annual renewal dates.
new text end

new text begin (b) Formularies must be organized and disclosed consistent with the most recent version
of the United States Pharmacopeia's (USP) Model Guidelines.
new text end

new text begin (c) For each item or category of items on the formulary, the specific enrollee benefit
terms must be identified, including enrollee cost-sharing and expected out-of-pocket costs.
new text end

new text begin Subd. 3. new text end

new text begin Formulary changes. new text end

new text begin (a) Once a formulary has been established, a health plan
company may, at any time during the enrollee's contract term:
new text end

new text begin (1) expand its formulary by adding drugs to the formulary;
new text end

new text begin (2) reduce co-payments or coinsurance; or
new text end

new text begin (3) move a drug to a benefit category that reduces an enrollee's cost.
new text end

new text begin (b) A health plan company may remove a brand name drug from the plan's formulary
or place a brand name drug in a benefit category that increases an enrollee's cost only upon
the addition to the formulary of a generic or multisource brand name drug rated as
therapeutically equivalent according to the FDA Orange Book or a biologic drug rated as
interchangeable according to the FDA Purple Book at a lower cost to the enrollee, and upon
at least a 60-day notice to prescribers, pharmacists, and affected enrollees.
new text end

new text begin (c) A health plan company may change utilization review requirements or move drugs
to a benefit category that increases an enrollee's cost during the enrollee's contract term
upon at least a 60-day notice to prescribers, pharmacists, and affected enrollees, provided
that these changes do not apply to enrollees who are currently taking the drugs affected by
these changes for the duration of the enrollee's contract term.
new text end

new text begin (d) A health plan company may remove any drugs from the plan's formulary that have
been deemed unsafe by the Food and Drug Administration, that have been withdrawn by
either the Food and Drug Administration or the product manufacturer, or when an
independent source of research, clinical guidelines, or evidence-based standards has issued
drug-specific warnings or recommended changes in drug usage.
new text end

new text begin Subd. 4. new text end

new text begin Not severable. new text end

new text begin The provisions of this section shall not be severable from article
1 of this act. If any provision of article 1 of this act or its application to any individual,
entity, or circumstance is found to be void for any reason, this section shall be void also.
new text end

new text begin EFFECTIVE DATE. new text end

new text begin This section is effective January 1, 2023, and applies to health
plans offered, sold, issued, or renewed on or after that date.
new text end