1.1.................... moves to amend H.F. No. 3138, the second engrossment, as follows:
1.2Page 116, after line 15, insert:
1.3 "Section 1. Minnesota Statutes 2016, section 8.31, subdivision 1, is amended to read:
1.4 Subdivision 1.
Investigate offenses against provisions of certain designated sections;
1.5assist in enforcement. The attorney general shall investigate violations of the law of this
1.6state respecting unfair, discriminatory, and other unlawful practices in business,
commerce,
1.7or trade, and specifically, but not exclusively,
prohibition against price gouging for essential
1.8off-patent or generic drugs (section 151.462), the Nonprofit Corporation Act (sections
1.9317A.001
to 317A.909), the Act Against Unfair Discrimination and Competition (sections
1.10325D.01
to 325D.07), the Unlawful Trade Practices Act (sections
325D.09 to 325D.16),
1.11the Antitrust Act (sections
325D.49 to 325D.66), section
325F.67 and other laws against
1.12false or fraudulent advertising, the antidiscrimination acts contained in section
325D.67,
1.13the act against monopolization of food products (section 325D.68), the act regulating
1.14telephone advertising services (section 325E.39), the Prevention of Consumer Fraud
Act
1.15(sections
325F.68 to 325F.70), and chapter 53A regulating currency exchanges and assist
1.16in the enforcement of those laws as in this section provided.
1.17EFFECTIVE DATE.This section is effective July 1, 2018."
1.18Page 119, after line 9, insert:
1.19 "Sec. 3. Minnesota Statutes 2016, section 151.071, subdivision 2, is amended to read:
1.20 Subd. 2.
Grounds for disciplinary action. The following conduct is prohibited and is
1.21grounds for disciplinary action:
1.22(1) failure to demonstrate the qualifications or satisfy the requirements for a license
or
1.23registration contained in this chapter or the rules of the board. The burden of proof
is on
1.24the applicant to demonstrate such qualifications or satisfaction of such requirements;
2.1(2) obtaining a license by fraud or by misleading the board in any way during the
2.2application process or obtaining a license by cheating, or attempting to subvert the
licensing
2.3examination process. Conduct that subverts or attempts to subvert the licensing examination
2.4process includes, but is not limited to: (i) conduct that violates the security of
the examination
2.5materials, such as removing examination materials from the examination room or having
2.6unauthorized possession of any portion of a future, current, or previously administered
2.7licensing examination; (ii) conduct that violates the standard of test administration,
such as
2.8communicating with another examinee during administration of the examination, copying
2.9another examinee's answers, permitting another examinee to copy one's answers, or
2.10possessing unauthorized materials; or (iii) impersonating an examinee or permitting
an
2.11impersonator to take the examination on one's own behalf;
2.12(3) for a pharmacist, pharmacy technician, pharmacist intern, applicant for a pharmacist
2.13or pharmacy license, or applicant for a pharmacy technician or pharmacist intern registration,
2.14conviction of a felony reasonably related to the practice of pharmacy. Conviction
as used
2.15in this subdivision includes a conviction of an offense that if committed in this
state would
2.16be deemed a felony without regard to its designation elsewhere, or a criminal proceeding
2.17where a finding or verdict of guilt is made or returned but the adjudication of guilt
is either
2.18withheld or not entered thereon. The board may delay the issuance of a new license
or
2.19registration if the applicant has been charged with a felony until the matter has
been
2.20adjudicated;
2.21(4) for a facility, other than a pharmacy, licensed or registered by the board, if
an owner
2.22or applicant is convicted of a felony reasonably related to the operation of the facility.
The
2.23board may delay the issuance of a new license or registration if the owner or applicant
has
2.24been charged with a felony until the matter has been adjudicated;
2.25(5) for a controlled substance researcher, conviction of a felony reasonably related
to
2.26controlled substances or to the practice of the researcher's profession. The board
may delay
2.27the issuance of a registration if the applicant has been charged with a felony until
the matter
2.28has been adjudicated;
2.29(6) disciplinary action taken by another state or by one of this state's health licensing
2.30agencies:
2.31(i) revocation, suspension, restriction, limitation, or other disciplinary action
against a
2.32license or registration in another state or jurisdiction, failure to report to the
board that
2.33charges or allegations regarding the person's license or registration have been brought
in
2.34another state or jurisdiction, or having been refused a license or registration by
any other
3.1state or jurisdiction. The board may delay the issuance of a new license or registration
if an
3.2investigation or disciplinary action is pending in another state or jurisdiction until
the
3.3investigation or action has been dismissed or otherwise resolved; and
3.4(ii) revocation, suspension, restriction, limitation, or other disciplinary action
against a
3.5license or registration issued by another of this state's health licensing agencies,
failure to
3.6report to the board that charges regarding the person's license or registration have
been
3.7brought by another of this state's health licensing agencies, or having been refused
a license
3.8or registration by another of this state's health licensing agencies. The board may
delay the
3.9issuance of a new license or registration if a disciplinary action is pending before
another
3.10of this state's health licensing agencies until the action has been dismissed or otherwise
3.11resolved;
3.12(7) for a pharmacist, pharmacy, pharmacy technician, or pharmacist intern, violation
of
3.13any order of the board, of any of the provisions of this chapter or any rules of the
board or
3.14violation of any federal, state, or local law or rule reasonably pertaining to the
practice of
3.15pharmacy;
3.16(8) for a facility, other than a pharmacy, licensed by the board, violations of any
order
3.17of the board, of any of the provisions of this chapter or the rules of the board or
violation
3.18of any federal, state, or local law relating to the operation of the facility;
3.19(9) engaging in any unethical conduct; conduct likely to deceive, defraud, or harm
the
3.20public, or demonstrating a willful or careless disregard for the health, welfare,
or safety of
3.21a patient; or pharmacy practice that is professionally incompetent, in that it may
create
3.22unnecessary danger to any patient's life, health, or safety, in any of which cases,
proof of
3.23actual injury need not be established;
3.24(10) aiding or abetting an unlicensed person in the practice of pharmacy, except that
it
3.25is not a violation of this clause for a pharmacist to supervise a properly registered
pharmacy
3.26technician or pharmacist intern if that person is performing duties allowed by this
chapter
3.27or the rules of the board;
3.28(11) for an individual licensed or registered by the board, adjudication as mentally
ill
3.29or developmentally disabled, or as a chemically dependent person, a person dangerous
to
3.30the public, a sexually dangerous person, or a person who has a sexual psychopathic
3.31personality, by a court of competent jurisdiction, within or without this state. Such
3.32adjudication shall automatically suspend a license for the duration thereof unless
the board
3.33orders otherwise;
4.1(12) for a pharmacist or pharmacy intern, engaging in unprofessional conduct as specified
4.2in the board's rules. In the case of a pharmacy technician, engaging in conduct specified
in
4.3board rules that would be unprofessional if it were engaged in by a pharmacist or
pharmacist
4.4intern or performing duties specifically reserved for pharmacists under this chapter
or the
4.5rules of the board;
4.6(13) for a pharmacy, operation of the pharmacy without a pharmacist present and on
4.7duty except as allowed by a variance approved by the board;
4.8(14) for a pharmacist, the inability to practice pharmacy with reasonable skill and
safety
4.9to patients by reason of illness, drunkenness, use of drugs, narcotics, chemicals,
or any other
4.10type of material or as a result of any mental or physical condition, including deterioration
4.11through the aging process or loss of motor skills. In the case of registered pharmacy
4.12technicians, pharmacist interns, or controlled substance researchers, the inability
to carry
4.13out duties allowed under this chapter or the rules of the board with reasonable skill
and
4.14safety to patients by reason of illness, drunkenness, use of drugs, narcotics, chemicals,
or
4.15any other type of material or as a result of any mental or physical condition, including
4.16deterioration through the aging process or loss of motor skills;
4.17(15) for a pharmacist, pharmacy, pharmacist intern, pharmacy technician, medical gas
4.18distributor, or controlled substance researcher, revealing a privileged communication
from
4.19or relating to a patient except when otherwise required or permitted by law;
4.20(16) for a pharmacist or pharmacy, improper management of patient records, including
4.21failure to maintain adequate patient records, to comply with a patient's request made
pursuant
4.22to sections
144.291 to
144.298, or to furnish a patient record or report required by law;
4.23(17) fee splitting, including without limitation:
4.24(i) paying, offering to pay, receiving, or agreeing to receive, a commission, rebate,
4.25kickback, or other form of remuneration, directly or indirectly, for the referral
of patients;
4.26and
4.27(ii) referring a patient to any health care provider as defined in sections
144.291 to
4.28144.298
in which the licensee or registrant has a financial or economic interest as defined
4.29in section
144.6521, subdivision 3, unless the licensee or registrant has disclosed the
4.30licensee's or registrant's financial or economic interest in accordance with section
144.6521;
4.31(18) engaging in abusive or fraudulent billing practices, including violations of
the
4.32federal Medicare and Medicaid laws or state medical assistance laws or rules;
5.1(19) engaging in conduct with a patient that is sexual or may reasonably be interpreted
5.2by the patient as sexual, or in any verbal behavior that is seductive or sexually
demeaning
5.3to a patient;
5.4(20) failure to make reports as required by section
151.072 or to cooperate with an
5.5investigation of the board as required by section
151.074;
5.6(21) knowingly providing false or misleading information that is directly related
to the
5.7care of a patient unless done for an accepted therapeutic purpose such as the dispensing
and
5.8administration of a placebo;
5.9(22) aiding suicide or aiding attempted suicide in violation of section
609.215 as
5.10established by any of the following:
5.11(i) a copy of the record of criminal conviction or plea of guilty for a felony in
violation
5.12of section
609.215, subdivision 1 or 2;
5.13(ii) a copy of the record of a judgment of contempt of court for violating an injunction
5.14issued under section
609.215, subdivision 4;
5.15(iii) a copy of the record of a judgment assessing damages under section
609.215,
5.16subdivision 5; or
5.17(iv) a finding by the board that the person violated section
609.215, subdivision 1 or 2.
5.18The board shall investigate any complaint of a violation of section
609.215, subdivision 1
5.19or 2;
5.20(23) for a pharmacist, practice of pharmacy under a lapsed or nonrenewed license.
For
5.21a pharmacist intern, pharmacy technician, or controlled substance researcher, performing
5.22duties permitted to such individuals by this chapter or the rules of the board under
a lapsed
5.23or nonrenewed registration. For a facility required to be licensed under this chapter,
operation
5.24of the facility under a lapsed or nonrenewed license or registration;
and
5.25(24) for a pharmacist, pharmacist intern, or pharmacy technician, termination or discharge
5.26from the health professionals services program for reasons other than the satisfactory
5.27completion of the program
; and
5.28(25) for a manufacturer or wholesale drug distributor, a violation of section 151.462.
5.29EFFECTIVE DATE.This section is effective July 1, 2018."
6.1Page 119, after line 20, insert:
6.2 "Sec. 5.
[151.462] PROHIBITION AGAINST PRICE GOUGING FOR ESSENTIAL
6.3OFF-PATENT OR GENERIC DRUGS.
6.4 Subdivision 1. Definitions. (a) For purposes of this section, the following definitions
6.5apply.
6.6(b) "Essential off-patent or generic drug" means any prescription drug:
6.7(1) for which all exclusive marketing rights, if any, granted under the federal Food,
6.8Drug, and Cosmetic Act, United States Code, title 21, chapter 9; section 351 of the
federal
6.9Public Health Service Act, United States Code, title 42, section 262; and federal
patent law
6.10have expired;
6.11(2) that has been designated by the board or commissioner of human services as an
6.12essential medicine due to its efficacy in treating a life-threatening health condition
or a
6.13chronic health condition that substantially impairs an individual's ability to engage
in
6.14activities of daily living;
6.15(3) that is actively manufactured and marketed for sale in the United States by three
or
6.16fewer manufacturers; and
6.17(4) that is made available for sale in the state of Minnesota.
6.18Essential off-patent or generic drug includes any drug-device combination product
used for
6.19the delivery of a drug for which all exclusive marketing rights, if any, granted under
the
6.20federal Food, Drug, and Cosmetic Act, section 351 of the federal Public Health Service
6.21Act, and federal patent law have expired.
6.22(c) "Health plan company" has the meaning provided in section 62Q.01, subdivision
4.
6.23(d) "Price gouging" means an unconscionable increase in the price of a prescription
6.24drug.
6.25(e) "Unconscionable increase" means an increase in the price of a prescription drug
that:
6.26(1) is excessive and not justified by the cost of producing the drug or the cost of
6.27appropriate expansion of access to the drug to promote public health; and
6.28(2) results in consumers for whom the drug has been prescribed, the commissioner of
6.29human services, and health plan companies having no meaningful choice about whether
to
6.30purchase the drug at an excessive price because of:
6.31(i) the importance of the drug to the health of the consumer; and
7.1(ii) insufficient competition in the market for the drug.
7.2(f) "Wholesale acquisition cost" has the meaning given in United States Code, title
42,
7.3section 1395w-3a.
7.4 Subd. 2. Prohibition. A manufacturer or wholesale drug distributor may not engage in
7.5price gouging in the sale of an essential off-patent or generic drug. It is not a
violation of
7.6this subdivision for a wholesale drug distributor to increase the price of an essential
off-patent
7.7or generic drug if the price increase is directly attributable to additional costs
for the drug
7.8imposed on the wholesale drug distributor by the manufacturer of the drug.
7.9 Subd. 3. Notification of attorney general. (a) The board, the commissioner of human
7.10services, or a health plan company may notify the attorney general of any increase
in the
7.11price of an essential off-patent or generic drug when:
7.12(1) the price increase, by itself or in combination with other price increases:
7.13(i) would result in an increase of 50 percent or more, compared to the preceding one-year
7.14period, in the wholesale acquisition cost of the drug or other relevant measure of
drug cost;
7.15or
7.16(ii) would result in an increase of 50 percent or more in the price paid by the medical
7.17assistance or MinnesotaCare programs, or the health plan company, for the drug compared
7.18to the preceding one-year period; and
7.19(2)(i) a 30-day supply of the maximum recommended dosage of the drug for any
7.20indication, according to the label for the drug approved under the federal Food, Drug,
and
7.21Cosmetic Act, would cost more than $80 at the drug's wholesale acquisition cost;
7.22(ii) a full course of treatment with the drug, according to the label for the drug
approved
7.23under the federal Food, Drug, and Cosmetic Act, would cost more than $80 at the drug's
7.24wholesale acquisition cost; or
7.25(iii) if the drug is made available to consumers only in quantities that do not correspond
7.26to a 30-day supply, a full course of treatment, or a single dose, it would cost more
than $80
7.27at the drug's wholesale acquisition cost to obtain a 30-day supply or a full course
of treatment.
7.28The commissioner of human services and the health plan company shall notify the board
7.29of any notification to the attorney general provided under this paragraph.
7.30(b) On request of the attorney general, the manufacturer of an essential off-patent
or
7.31generic drug identified in a notice under paragraph (a) shall, within 45 days after
the request,
7.32submit a statement to the attorney general:
8.1(1) itemizing the components of the cost of producing the drug;
8.2(2) identifying the circumstances and timing of any increase in materials or manufacturing
8.3costs that caused any increase in the price of the drug within the one-year period
preceding
8.4the date of the price increase;
8.5(3) identifying the circumstances and timing of any expenditures made by the
8.6manufacturer to expand access to the drug and explaining any improvement in public
health
8.7associated with those expenditures; and
8.8(4) providing any other information that the manufacturer believes to be relevant
to a
8.9determination of whether a violation of this section has occurred.
8.10(c) The attorney general may require a manufacturer or a wholesale drug distributor
to
8.11produce any records or other documents that may be relevant to a determination of
whether
8.12a violation of this section has occurred. The attorney general or a person may use
the powers
8.13and procedures provided in this section or section 8.31.
8.14(d) The attorney general may not bring an action for a remedy under paragraph (c)
unless
8.15the attorney general has provided the manufacturer or wholesale drug distributor an
8.16opportunity to meet with the attorney general to offer a justification for the increase
in the
8.17price of the essential off-patent or generic drug.
8.18(e) The attorney general shall make any information provided by a health plan company,
8.19manufacturer, or wholesale drug distributor under paragraphs (a), (b), and (c) available
to
8.20the board upon request. Any information provided by a health plan company, manufacturer,
8.21or wholesale drug distributor to the attorney general under paragraphs (a), (b), and
(c) shall
8.22be treated as nonpublic data under section 13.02, subdivision 9, unless the nonpublic
8.23classification of the information is waived by the health plan company, manufacturer,
or
8.24wholesale drug distributor.
8.25(f) In any action brought by the attorney general under paragraph (c), a person who
is
8.26alleged to have violated a requirement of this section may not assert as a defense
that the
8.27person did not deal directly with a consumer residing in the state.
8.28 Subd. 4. Private right of action. In addition to remedies otherwise provided by law,
8.29any person injured by a violation of this section may bring a civil action and recover
damages,
8.30together with costs and disbursements, including costs of investigation and reasonable
8.31attorney fees, and receive other equitable relief as determined by the court. The
court may,
8.32as appropriate, enter a consent judgment or decree without the finding of illegality.
Any
8.33civil action brought under this subdivision is for the benefit of the public.
9.1EFFECTIVE DATE.This section is effective July 1, 2018."
9.2Renumber the sections in sequence and correct the internal references
9.3Amend the title accordingly