75th OREGON LEGISLATIVE ASSEMBLY--2009 Regular Session
HA to HB 2376
LC 281/HB 2376-3
HOUSE AMENDMENTS TO
HOUSE BILL 2376
By COMMITTEE ON HEALTH CARE
April 7
On page 1 of the printed bill, line 2, delete ' appropriating'
and insert 'creating new provisions; amending ORS 646.608;'.
In line 3, delete 'money;'.
Delete lines 5 through 27 and delete page 2 and insert:
' { + SECTION 1. + } { + (1) As used in this section:
' (a) 'Applicable group purchasing organization' means a group
purchasing organization, as defined by the Department of Justice
by rule, that purchases or arranges for or negotiates the
purchase of a covered drug, device, biological product or medical
supply.
' (b) 'Applicable manufacturer' means a manufacturer of a
covered drug, device, biological product or medical supply.
' (c) 'Clinical investigation' means any experiment involving
one or more human subjects in which a drug or device is
administered, dispensed or used.
' (d) 'Covered device' means any device that is covered by
Medicare or the medical assistance program.
' (e) 'Covered drug, device, biological product or medical
supply' means any drug, device, biological product or medical
supply that is covered by Medicare or the medical assistance
program.
' (f)(A) 'Covered recipient' means:
' (i) A physician.
' (ii) A physician medical practice.
' (iii) A physician group practice.
' (iv) A pharmacist licensed under ORS chapter 689.
' (v) A health practitioner, as defined by the department by
rule, who is licensed, certified, registered or otherwise
authorized by law to prescribe and administer drugs in this
state.
' (vi) A provider of continuing medical education.
' (B) 'Covered recipient' does not include an employee of an
applicable manufacturer that is required to submit information
under subsections (2) to (5) of this section.
' (g) 'Employee' has the meaning given that term in 42
U.S.C. 1395nn(h)(2).
' (h) 'Manufacturer of a covered drug, device, biological
product or medical supply' means any entity that is engaged in
the production, preparation, propagation, compounding,
conversion, processing, marketing or distribution of a covered
drug, device, biological product or medical supply or any
subsidiary of or entity affiliated with such entity.
' (i) 'Payment or other transfer of value':
' (A) Means a transfer of anything of value.
' (B) Includes, subject to subparagraph (C) of this paragraph,
without limitation, any compensation, gift, honorarium, speaking
fee, consulting fee, travel, services, dividend, profit
distribution, stock or stock option grant, or ownership or
investment interest.
' (C) Does not mean:
' (i) Any payment or other transfer of value provided by an
applicable manufacturer to a covered recipient if the aggregate
amount transferred to, requested by or designated on behalf of
the covered recipient does not exceed $100 during the calendar
year, excluding items described in sub-subparagraphs (ii) to (ix)
of this subparagraph.
' (ii) Product samples that are not intended to be sold and are
intended for patient use.
' (iii) Educational materials that directly benefit patients or
are intended for patient use.
' (iv) The loan of a covered device for a short-term trial
period, not to exceed 90 days, to permit evaluation of the
covered device by the covered recipient.
' (v) Items or services provided under a contractual warranty,
including the replacement of a covered device, for which the
terms of the warranty are set forth in the purchase or lease
agreement for the covered device.
' (vi) A transfer of anything of value to a covered recipient
if the covered recipient is a patient and is not acting in the
professional capacity of a covered recipient.
' (vii) Discounts, including rebates.
' (viii) In-kind items used in the provision of charity care.
' (ix) A dividend or other profit distribution from, or
ownership or investment interest in, a publicly traded security
or mutual fund.
' (j) 'Physician' means:
' (A) A doctor of medicine or osteopathy who is legally
authorized to practice medicine and surgery in the state where
the person practices medicine and surgery.
' (B) A doctor of dental surgery or dental medicine who is
legally authorized to practice dentistry in the state where the
person practices dentistry.
' (C) A doctor of podiatric medicine who is legally authorized
to practice podiatric medicine in the state where the person
practices podiatric medicine.
' (D) A doctor of naturopathic medicine who is legally
authorized to practice naturopathic medicine in the state where
the person practices naturopathic medicine.
' (2) Except as provided in subsection (10) of this section, on
or before the 90th day of each calendar year, any applicable
manufacturer that provides a payment or other transfer of value
to a covered recipient, or to an entity or individual at the
request of or designated on behalf of a covered recipient, shall
submit to the department, in such electronic form as the
department requires, the following information with respect to
the preceding calendar year:
' (a) The name of the covered recipient.
' (b) The business address of the covered recipient and, in the
case of a covered recipient who is a physician, the specialty and
Medicare billing number of the covered recipient.
' (c) The value of the payment or other transfer of value.
' (d) The dates on which the payment or other transfer of value
was provided to the covered recipient.
' (e) A description of the form of the payment or other
transfer of value, indicated as:
' (A) Cash or a cash equivalent;
' (B) In-kind items or services;
' (C) Stock, a stock option or any other ownership interest,
dividend, profit or other return on investment; or
' (D) Any other form of payment or other transfer of value as
defined by the department by rule.
' (f) A description of the nature of the payment or other
transfer of value, indicated, as appropriate for all that apply,
as:
' (A) Consulting fees;
' (B) Compensation for services other than consulting;
' (C) Honoraria;
' (D) Gifts;
' (E) Entertainment;
' (F) Food;
' (G) Travel;
' (H) Education;
' (I) Research;
' (J) Charitable contributions;
' (K) Royalties or licenses;
' (L) Current or prospective ownership or investment interest;
' (M) Compensation for serving as faculty or as a speaker for a
continuing medical education program;
' (N) Grants; or
' (O) Any other payment or other transfer of value as defined
by the department by rule.
' (g) If the payment or other transfer of value is related to
marketing, education or research specific to a covered drug,
device, biological product or medical supply, the name of that
covered drug, device, biological product or medical supply.
' (h) Any other categories of information regarding the payment
or other transfer of value that the department determines
appropriate.
' (3) Information submitted by an applicable manufacturer under
subsection (2) of this section must include the aggregate amount
of all payments or other transfers of value provided during the
preceding calendar year by the applicable manufacturer to covered
recipients and to entities or individuals at the request of or
designated on behalf of a covered recipient.
' (4) If an applicable manufacturer provides a payment or other
transfer of value to an entity or individual at the request of or
designated on behalf of a covered recipient, the applicable
manufacturer shall disclose that payment or other transfer of
value under the name of the covered recipient.
' (5) In addition to the requirements of subsection (2) of this
section, on or before the 90th day of each calendar year, any
applicable manufacturer or applicable group purchasing
organization shall submit to the department, in such electronic
form as the department requires, the following information
regarding any ownership or investment interest in the applicable
manufacturer or applicable group purchasing organization during
the preceding calendar year, other than an ownership or
investment interest in a publicly traded security or mutual fund
held by a physician or an immediate family member of the
physician:
' (a) The dollar amount invested by each covered recipient
holding such an ownership or investment interest.
' (b) The value and terms of each such ownership or investment
interest.
' (c) Any payment or other transfer of value provided to a
covered recipient, including the information described in
subsection (2)(a) to (g) of this section.
' (d) Any other information regarding the ownership or
investment interest the department determines appropriate.
' (6) The department shall establish procedures:
' (a) For applicable manufacturers and applicable group
purchasing organizations to submit information to the department
under subsections (2) to (5) of this section; and
' (b) For the department to make the information submitted
available to the public.
' (7) The department shall make available the information
submitted under subsections (2) to (5) of this section with
respect to the preceding calendar year through a website that:
' (a) Is searchable and is in a format that is clear and
understandable;
' (b) Contains the name of the applicable manufacturer or
applicable group purchasing organization, the name of the covered
recipient, the business address of the covered recipient, the
specialty of the covered recipient, the value of the payment or
other transfer of value, the date on which the payment or other
transfer of value was provided to the covered recipient, the form
of the payment or other transfer of value indicated under
subsection (2)(e) of this section, the nature of the payment or
other transfer of value indicated under subsection (2)(f) of this
section and the name of the covered drug, device, biological
product or medical supply;
' (c) Contains information that is able to be easily aggregated
and downloaded;
' (d) Contains a description of any enforcement actions taken
to carry out this section during the preceding calendar year;
' (e) Contains background information on the relationships of
the pharmaceutical industry and covered recipients;
' (f) Separates the information submitted with respect to a
payment or other transfer of value described in subsection (10)
of this section, from the information submitted under subsections
(2) to (5) of this section and designates the separately listed
information as funding for clinical research;
' (g) Contains any other information that the department deems
to be helpful to the average consumer; and
' (h) Provides the covered recipient an opportunity to submit
corrections to the information to be made available to the public
with respect to the covered recipient.
' (8) In establishing the procedures under subsections (6) and
(7) of this section, the department shall consult with the
affected industry, consumers, consumer advocates and other
interested parties in order to ensure that the information made
available to the public under subsections (6) and (7) of this
section is presented in the appropriate overall context.
' (9) No later than April 1 of each year, the department shall
submit to the Legislative Assembly or to the interim legislative
committees related to health a report that includes the
following:
' (a) The information submitted under subsections (2) to (5) of
this section during the preceding calendar year, aggregated for
each applicable manufacturer and applicable group purchasing
organization that submitted the information.
' (b) A description of any enforcement actions taken to carry
out this section during the preceding calendar year.
' (10) In the case of a payment or other transfer of value made
to a covered recipient by an applicable manufacturer pursuant to
a product development agreement for services furnished in
connection with the development of a new drug, device, biological
product or medical supply, or by an applicable manufacturer in
connection with a clinical investigation, the applicable
manufacturer may report the value of such payment or other
transfer of value in the first reporting period under subsections
(2) to (5) of this section after the earlier of the following:
' (a) The date of the approval or clearance of the covered
drug, device, biological product or medical supply by the United
States Food and Drug Administration.
' (b) Two calendar years after the date the payment or other
transfer of value was made.
' (11) The department may adopt rules to carry out this
section, including rules defining terms not otherwise defined in
subsection (1) of this section. + }
' { + SECTION 2. + } ORS 646.608, as amended by section 8,
chapter 19, Oregon Laws 2008, and section 5, chapter 31, Oregon
Laws 2008, is amended to read:
' 646.608. (1) A person engages in an unlawful practice when in
the course of the person's business, vocation or occupation the
person does any of the following:
' (a) Passes off real estate, goods or services as those of
another.
' (b) Causes likelihood of confusion or of misunderstanding as
to the source, sponsorship, approval, or certification of real
estate, goods or services.
' (c) Causes likelihood of confusion or of misunderstanding as
to affiliation, connection, or association with, or certification
by, another.
' (d) Uses deceptive representations or designations of
geographic origin in connection with real estate, goods or
services.
' (e) Represents that real estate, goods or services have
sponsorship, approval, characteristics, ingredients, uses,
benefits, quantities or qualities that they do not have or that a
person has a sponsorship, approval, status, qualification,
affiliation, or connection that the person does not have.
' (f) Represents that real estate or goods are original or new
if they are deteriorated, altered, reconditioned, reclaimed, used
or secondhand.
' (g) Represents that real estate, goods or services are of a
particular standard, quality, or grade, or that real estate or
goods are of a particular style or model, if they are of another.
' (h) Disparages the real estate, goods, services, property or
business of a customer or another by false or misleading
representations of fact.
' (i) Advertises real estate, goods or services with intent not
to provide them as advertised, or with intent not to supply
reasonably expectable public demand, unless the advertisement
discloses a limitation of quantity.
' (j) Makes false or misleading representations of fact
concerning the reasons for, existence of, or amounts of price
reductions.
' (k) Makes false or misleading representations concerning
credit availability or the nature of the transaction or
obligation incurred.
' (L) Makes false or misleading representations relating to
commissions or other compensation to be paid in exchange for
permitting real estate, goods or services to be used for model or
demonstration purposes or in exchange for submitting names of
potential customers.
' (m) Performs service on or dismantles any goods or real
estate when not authorized by the owner or apparent owner
thereof.
' (n) Solicits potential customers by telephone or door to door
as a seller unless the person provides the information required
under ORS 646.611.
' (o) In a sale, rental or other disposition of real estate,
goods or services, gives or offers to give a rebate or discount
or otherwise pays or offers to pay value to the customer in
consideration of the customer giving to the person the names of
prospective purchasers, lessees, or borrowers, or otherwise
aiding the person in making a sale, lease, or loan to another
person, if earning the rebate, discount or other value is
contingent upon occurrence of an event subsequent to the time the
customer enters into the transaction.
' (p) Makes any false or misleading statement about a prize,
contest or promotion used to publicize a product, business or
service.
' (q) Promises to deliver real estate, goods or services within
a certain period of time with intent not to deliver them as
promised.
' (r) Organizes or induces or attempts to induce membership in
a pyramid club.
' (s) Makes false or misleading representations of fact
concerning the offering price of, or the person's cost for real
estate, goods or services.
' (t) Concurrent with tender or delivery of any real estate,
goods or services fails to disclose any known material defect or
material nonconformity.
' (u) Engages in any other unfair or deceptive conduct in trade
or commerce.
' (v) Violates any of the provisions relating to auction sales,
auctioneers or auction marts under ORS 698.640, whether in a
commercial or noncommercial situation.
' (w) Manufactures mercury fever thermometers.
' (x) Sells or supplies mercury fever thermometers unless the
thermometer is required by federal law, or is:
' (A) Prescribed by a person licensed under ORS chapter 677;
and
' (B) Supplied with instructions on the careful handling of the
thermometer to avoid breakage and on the proper cleanup of
mercury should breakage occur.
' (y) Sells a thermostat that contains mercury unless the
thermostat is labeled in a manner to inform the purchaser that
mercury is present in the thermostat and that the thermostat may
not be disposed of until the mercury is removed, reused, recycled
or otherwise managed to ensure that the mercury does not become
part of the solid waste stream or wastewater. For purposes of
this paragraph, 'thermostat' means a device commonly used to
sense and, through electrical communication with heating, cooling
or ventilation equipment, control room temperature.
' (z) Sells or offers for sale a motor vehicle manufactured
after January 1, 2006, that contains mercury light switches.
' (aa) Violates the provisions of ORS 803.375, 803.385 or
815.410 to 815.430.
' (bb) Violates ORS 646A.070 (1).
' (cc) Violates any requirement of ORS 646A.030 to 646A.040.
' (dd) Violates the provisions of ORS 128.801 to 128.898.
' (ee) Violates ORS 646.883 or 646.885.
' (ff) Violates any provision of ORS 646A.020.
' (gg) Violates ORS 646.569.
' (hh) Violates the provisions of ORS 646A.142.
' (ii) Violates ORS 646A.360.
' (jj) Violates ORS 646.553 or 646.557 or any rule adopted
pursuant thereto.
' (kk) Violates ORS 646.563.
' (LL) Violates ORS 759.690 or any rule adopted pursuant
thereto.
' (mm) Violates the provisions of ORS 759.705, 759.710 and
759.720 or any rule adopted pursuant thereto.
' (nn) Violates ORS 646A.210 or 646A.214.
' (oo) Violates any provision of ORS 646A.124 to 646A.134.
' (pp) Violates ORS 646A.254.
' (qq) Violates ORS 646A.095.
' (rr) Violates ORS 822.046.
' (ss) Violates ORS 128.001.
' (tt) Violates ORS 646.649 (2) to (4).
' (uu) Violates ORS 646A.090 (2) to (4).
' (vv) Violates ORS 87.686.
' (ww) Violates ORS 646.651.
' (xx) Violates ORS 646A.362.
' (yy) Violates ORS 646A.052 or any rule adopted under ORS
646A.052 or 646A.054.
' (zz) Violates ORS 180.440 (1).
' (aaa) Commits the offense of acting as a vehicle dealer
without a certificate under ORS 822.005.
' (bbb) Violates ORS 87.007 (2) or (3).
' (ccc) Violates ORS 92.405 (1), (2) or (3).
' (ddd) Engages in an unlawful practice under ORS 646.648.
' (eee) Violates ORS 646A.365.
' (fff) Violates ORS 98.854 or 98.858 or a rule adopted under
ORS 98.864.
' (ggg) Sells a gift card in violation of ORS 646A.276.
' (hhh) Violates ORS 646A.102, 646A.106 or 646A.108.
' (iii) Violates ORS 646A.430 to 646A.450.
' (jjj) Violates a provision of sections 2 to 6, chapter 19,
Oregon Laws 2008.
' (kkk) Violates section 2, chapter 31, Oregon Laws 2008, 30 or
more days after a recall notice, warning or declaration described
in section 2, chapter 31, Oregon Laws 2008, is issued for the
children's product, as defined in section 1, chapter 31, Oregon
Laws 2008, that is the subject of the violation. { +
' (LLL) Violates section 1 of this 2009 Act. + }
' (2) A representation under subsection (1) of this section or
ORS 646.607 may be any manifestation of any assertion by words or
conduct, including, but not limited to, a failure to disclose a
fact.
' (3) In order to prevail in an action or suit under ORS
646.605 to 646.652, a prosecuting attorney need not prove
competition between the parties or actual confusion or
misunderstanding.
' (4) An action or suit may not be brought under subsection
(1)(u) of this section unless the Attorney General has first
established a rule in accordance with the provisions of ORS
chapter 183 declaring the conduct to be unfair or deceptive in
trade or commerce.
' (5) Notwithstanding any other provision of ORS 646.605 to
646.652, if an action or suit is brought under subsection (1)(zz)
of this section by a person other than a prosecuting attorney,
relief is limited to an injunction and the prevailing party may
be awarded reasonable attorney fees.
' { + (6) If a court finds that section 1 of this 2009 Act is
preempted by a federal law, a violation of that federal law shall
be an unlawful practice under this section. + }
' { + SECTION 3. + } { + Section 1 of this 2009 Act becomes
operative on November 1, 2009. + }
' { + SECTION 4. + } { + The Department of Justice may take
any action before the operative date of section 1 of this 2009
Act that is necessary for the department to carry out, on or
after the operative date of section 1 of this 2009 Act, the
duties and functions of the department under section 1 of this
2009 Act. + }
' { + SECTION 5. + } { + This 2009 Act being necessary for
the immediate preservation of the public peace, health and
safety, an emergency is declared to exist, and this 2009 Act
takes effect on its passage. + } ' .
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