Minnesota Legislature
HF 1641
as introduced - 86th Legislature (2009 - 2010) Posted on 02/09/2010 01:53am
Bill Text Versions
| Engrossments | ||
|---|---|---|
| Introduction | Posted on 03/11/2009 |
Current Version - as introduced
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A bill for an act
relating to health; preventing conflicts of interest; banning gifts from drug
or medical device manufacturers or distributors to physicians and formulary
committee members; amending Minnesota Statutes 2008, sections 151.461;
151.47, subdivision 1; 256B.0625, subdivision 13c; proposing coding for new
law in Minnesota Statutes, chapter 62J.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
Section 1.
new text begin
[62J.241] DISCLOSURE OF PAYMENTS TO PRACTITIONERS.
new text end
new text begin Subdivision 1. new text end
new text begin Disclosure required. new text end
new text begin
Each pharmaceutical manufacturer,
wholesale drug distributor, or medical device manufacturer or their agent shall file with
the commissioner of health an annual report that identifies all payments, honoraria,
reimbursement, or other compensation paid to practitioners or to sponsors of a medical
conference, professional meeting, or other educational program during the preceding
calendar year.
new text end
new text begin Subd. 2. new text end
new text begin Report format. new text end
new text begin
The format of the report shall be standardized and shall
include at a minimum the nature and value of any payment to a particular practitioner or
sponsor during the year and shall identify the practitioner or the sponsor. Reports filed
under this provision are public data and must be made available on the department Web
site in an easily accessible and searchable format.
new text end
Sec. 2.
Minnesota Statutes 2008, section 151.461, is amended to read:
151.461 GIFTS TO PRACTITIONERS PROHIBITED.
new text begin Subdivision 1. new text end
new text begin Prohibition. new text end
It is unlawful for any new text begin pharmaceutical new text end manufacturer deleted text begin ordeleted text end new text begin ,
new text end wholesale drug distributor, new text begin or medical device manufacturer or distributor, new text end or any agent
thereof, to offer or give any gift deleted text begin of valuedeleted text end new text begin or to request another person to give a giftnew text end to a
practitioner. deleted text begin A medical device manufacturer that distributes drugs as an incidental part of
its device business shall not be considered a manufacturer, a wholesale drug distributor,
or agent under this section.deleted text end new text begin A practitioner may not accept a gift from a manufacturer
or distributor or from an agent of either.
new text end
new text begin Subd. 2. new text end
new text begin Definition of gift. new text end
new text begin
For purposes of this section, "gift" has the meaning
given under section 10A.071.
new text end
new text begin Subd. 3. new text end
new text begin Exceptions. new text end
deleted text begin As used in this section, "gift" does not includedeleted text end new text begin The prohibition
in this section does not apply tonew text end :
(1) professional samples of a drug provided to a deleted text begin prescriberdeleted text end new text begin practitioner new text end for free
distribution tonew text begin uninsured or low-incomenew text end patientsnew text begin , if there is evidence-based medicine to
support the clear superiority of the drug over less costly alternatives availablenew text end ;
deleted text begin
(2) items with a total combined retail value, in any calendar year, of not more than
$50;
deleted text end
deleted text begin (3) a paymentdeleted text end new text begin (2) an unrestricted grantnew text end to the sponsor of a medical conference,
professional meeting, or other educational program, providednew text begin that the grantor has no
influence on the content, presenters, or attendees at the event and providednew text end the payment is
deleted text begin not made directly to a practitioner and is useddeleted text end solely for bona fide educational purposesnew text begin ; is
made to underwrite the conference, meeting, or program; is not meant to subsidize any
particular attendees; and is not tied to the attendance of any particular practitionernew text end ;
deleted text begin (4)deleted text end new text begin (3)new text end reasonable honoraria and payment of the reasonable expenses of a practitioner
who serves on the faculty at a professional or educational conference or meetingnew text begin if the
honoraria for the speech or presentation does not exceed the standard hourly billing rate
of the practitionernew text end ;
deleted text begin (5)deleted text end new text begin (4)new text end compensation for the substantial professional or consulting services of
a practitioner in connection with a genuine research projectnew text begin that has the potential
of advancing medical care or establishing an improved understanding of the safety,
performance, or improvement in clinical outcomes of a drug or medical device. The
compensation for these services must not exceed the standard hourly billing rate of the
practitionernew text end ;
deleted text begin (6)deleted text end new text begin (5) informationalnew text end publications and educational materialsnew text begin , provided that the
materials were produced and published by the drug manufacturer or medical device
manufacturernew text end ; deleted text begin or
deleted text end
deleted text begin (7)deleted text end new text begin (6)new text end salaries or other benefits paid to employees.new text begin If a practitioner who is currently
practicing in Minnesota is also an employee or agent of a drug manufacturer, wholesale
drug distributor, or medical device manufacturer or distributor, the practitioner must
report the source, the amount, and the nature of the compensation received to the Board
of Medical Practice, and must notify a patient of the employment relationship before
prescribing or recommending any medication or medical device from that manufacturer or
distributor to the patient;
new text end
new text begin
(7) bona fide training or educational programs conducted or sponsored by a medical
device manufacturer or distributor for the sole purpose of training the practitioner in
the use of a medical device and any reasonable expenses associated with attending the
training or educational program; or
new text end
new text begin
(8) reasonable payment to the practitioner for intellectual property or patent royalties
on a medical device provided that the practitioner is named on the patent.
new text end
new text begin Subd. 4. new text end
new text begin Report. new text end
new text begin
(a) When a practitioner receives compensation under subdivision
3, clause (3), (4), or (8), the source, the amount, and the nature of the compensation must
be reported to the Board of Medical Practice, and the practitioner must notify a patient of
the existence of a financial relationship before prescribing any medication or device from
that manufacturer or distributor to the patient.
new text end
new text begin
(b) For purposes of this section, "practitioner" includes the employees of the
clinic or facility where the practitioner is practicing and includes family members of
the practitioner.
new text end
Sec. 3.
Minnesota Statutes 2008, section 151.47, subdivision 1, is amended to read:
Subdivision 1.
Requirements.
All wholesale drug distributors are subject to the
requirements in paragraphs (a) to (f).
(a) No person or distribution outlet shall act as a wholesale drug distributor without
first obtaining a license from the board and paying the required fee.
(b) No license shall be issued or renewed for a wholesale drug distributor to operate
unless the applicant agrees to operate in a manner prescribed by federal and state law and
according to the rules adopted by the board.
(c) The board may require a separate license for each facility directly or indirectly
owned or operated by the same business entity within the state, or for a parent entity
with divisions, subsidiaries, or affiliate companies within the state, when operations
are conducted at more than one location and joint ownership and control exists among
all the entities.
(d) As a condition for receiving and retaining a wholesale drug distributor license
issued under sections 151.42 to 151.51, an applicant shall satisfy the board that it has
and will continuously maintain:
(1) adequate storage conditions and facilities;
(2) minimum liability and other insurance as may be required under any applicable
federal or state law;
(3) a viable security system that includes an after hours central alarm, or comparable
entry detection capability; restricted access to the premises; comprehensive employment
applicant screening; and safeguards against all forms of employee theft;
(4) a system of records describing all wholesale drug distributor activities set forth
in section 151.44 for at least the most recent two-year period, which shall be reasonably
accessible as defined by board regulations in any inspection authorized by the board;
(5) principals and persons, including officers, directors, primary shareholders,
and key management executives, who must at all times demonstrate and maintain their
capability of conducting business in conformity with sound financial practices as well
as state and federal law;
(6) complete, updated information, to be provided to the board as a condition for
obtaining and retaining a license, about each wholesale drug distributor to be licensed,
including all pertinent corporate licensee information, if applicable, or other ownership,
principal, key personnel, and facilities information found to be necessary by the board;
(7) written policies and procedures that assure reasonable wholesale drug distributor
preparation for, protection against, and handling of any facility security or operation
problems, including, but not limited to, those caused by natural disaster or government
emergency, inventory inaccuracies or product shipping and receiving, outdated product
or other unauthorized product control, appropriate disposition of returned goods, and
product recalls;
(8) sufficient inspection procedures for all incoming and outgoing product
shipments; and
(9) operations in compliance with all federal requirements applicable to wholesale
drug distribution.
(e) An agent or employee of any licensed wholesale drug distributor need not seek
licensure under this section.
deleted text begin
(f) A wholesale drug distributor shall file with the board an annual report, in a
form and on the date prescribed by the board, identifying all payments, honoraria,
reimbursement or other compensation authorized under section 151.461, clauses (3) to
(5), paid to practitioners in Minnesota during the preceding calendar year. The report
shall identify the nature and value of any payments totaling $100 or more, to a particular
practitioner during the year, and shall identify the practitioner. Reports filed under this
provision are public data.
deleted text end
Sec. 4.
Minnesota Statutes 2008, section 256B.0625, subdivision 13c, is amended to
read:
Subd. 13c.
Formulary committee.
new text begin (a) new text end The commissioner, after receiving
recommendations from professional medical associations and professional pharmacy
associations, and consumer groups shall designate a Formulary Committee to carry
out duties as described in subdivisions 13 to 13g. The Formulary Committee shall be
comprised of four licensed physicians actively engaged in the practice of medicine in
Minnesota one of whom must be actively engaged in the treatment of persons with mental
illness; at least three licensed pharmacists actively engaged in the practice of pharmacy
in Minnesota; and one consumer representative; the remainder to be made up of health
care professionals who are licensed in their field and have recognized knowledge in the
clinically appropriate prescribing, dispensing, and monitoring of covered outpatient drugs.
Members of the Formulary Committee shall not be employed by the Department of Human
Services, but the committee shall be staffed by an employee of the department who shall
serve as an ex officio, nonvoting member of the committee. The department's medical
director shall also serve as an ex officio, nonvoting member for the committee. Committee
members shall serve three-year terms and may be reappointed by the commissioner. The
Formulary Committee shall meet at least quarterly. The commissioner may require more
frequent Formulary Committee meetings as needed. An honorarium of $100 per meeting
and reimbursement for mileage shall be paid to each committee member in attendance.
new text begin
(b) A member of the formulary committee may not accept a gift or any professional
samples from a drug manufacturer or wholesale drug distributor. A member of the
formulary committee may not be an employee or an agent of a drug manufacturer or
wholesale drug distributor.
new text end