SF 4083

as introduced - 91st Legislature (2019 - 2020) Posted on 03/06/2020 09:28am

A bill for an act
relating to health insurance; requiring manufacturers to report prescription drug
prices and maintain prices; amending Minnesota Statutes 2018, section 62A.02,
subdivision 1; Minnesota Statutes 2019 Supplement, section 151.071, subdivision
2; proposing coding for new law in Minnesota Statutes, chapter 151.

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

Section 1.

Minnesota Statutes 2018, 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 begin The filing must include the health plan's
prescription drug formulary. new text end The 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 2019 Supplement, 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
distributor, 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 shall 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 begin and
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 program deleted text begin . deleted text end new text begin ; and
new text end

new text begin (25) for a drug manufacturer, failure to comply with section 151.80.
new text end

Sec. 3.

new text begin [151.80] REPORTING PRESCRIPTION DRUG PRICES.
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) "Anatomical therapeutic chemical code" means the code given to a drug by the World
Health Organization classification system that groups the drug's active medical substances
according to the organ or system on which the drug acts and the drug's therapeutic,
pharmacological, and chemical properties.
new text end

new text begin (c) "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 (d) "Brand name drug" means a drug, including therapeutic biological products, marketed
under a proprietary, trademark-protected name.
new text end

new text begin (e) "Commissioner" means the commissioner of commerce.
new text end

new text begin (f) "Generic drug" means a drug created to be identical to an existing brand name drug
in dosage form, safety, strength, route of administration, quality, and performance
characteristics.
new text end

new text begin (g) "Generic product identifier" means a 14-character code that defines pharmaceutically
equivalent drugs that are identical in terms of active ingredient, route of administration,
dosage form, strength or concentration, and therapeutic use.
new text end

new text begin (h) "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 (i) "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 (j) "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 January 30, 2021, and by January 30 each year
thereafter, a manufacturer must report to the commissioner the information in paragraph
(b) for every drug with a wholesale acquisition cost of $25 or more, 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) generic product identifier and associated description;
new text end

new text begin (5) anatomical therapeutic chemical code and associated description;
new text end

new text begin (6) wholesale acquisition cost for one unit;
new text end

new text begin (7) measure that constitutes a wholesale acquisition cost unit;
new text end

new text begin (8) average wholesale price; and
new text end

new text begin (9) 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.
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 April 1 each year,
the commissioner must post to the department's website, in an easy-to-read format, the
information provided under subdivision 2.
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 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 a 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.
new text end