75th OREGON LEGISLATIVE ASSEMBLY--2009 Regular Session
NOTE: Matter within { + braces and plus signs + } in an
amended section is new. Matter within { - braces and minus
signs - } is existing law to be omitted. New sections are within
{ + braces and plus signs + } .
LC 1740
B-Engrossed
Senate Bill 355
Ordered by the Senate June 25
Including Senate Amendments dated April 16 and June 25
Sponsored by Senators MORRISETTE, KRUSE, BATES
SUMMARY
The following summary is not prepared by the sponsors of the
measure and is not a part of the body thereof subject to
consideration by the Legislative Assembly. It is an editor's
brief statement of the essential features of the measure.
{ - Requires State Board of Pharmacy to establish electronic
prescription monitoring program for information reported by
certain pharmacies regarding dispensing of certain prescription
drugs. - } { + Requires Department of Human Services to
establish and maintain prescription monitoring program for
monitoring and reporting certain prescription drugs dispensed by
pharmacies. + } Restricts access to and limits use of reported
information. Provides certain immunities from civil liability
relating to reporting or use of information.
{ - Authorizes board to impose on individual violator of
program and related provisions maximum penalty of $250 and on
drug outlet violator maximum penalty of $1,000. - }
{ + Authorizes Attorney General to impose civil penalty up to
maximum of $10,000 for each violation of program. + }
Requires licensees of certain boards to pay $25 annual fee for
prescribing and dispensing controlled substances. Establishes
Electronic Prescription Monitoring Fund consisting of portion of
fees. { + Continuously + } appropriates moneys in fund to
{ - State Board of Pharmacy - } { + department + } for purpose
of administering program.
Creates Prescription Monitoring Program Advisory Commission.
{ + Increases biennial expenditure limitation for payment of
expenses for health services from fees, moneys or other revenues,
including Miscellaneous Receipts, but excluding lottery funds and
federal funds, collected or received by department.
Increases certain biennial expenditure limitation for payment
of expenses from federal funds collected or received by
department. + }
Declares emergency, effective on passage.
A BILL FOR AN ACT
Relating to an electronic prescription monitoring program;
appropriating money; limiting expenditures; and declaring an
emergency.
Be It Enacted by the People of the State of Oregon:
SECTION 1. { + As used in sections 2 to 11 of this 2009 Act:
(1) 'Dispense' and 'dispensing' have the meanings given those
terms in ORS 689.005.
(2) 'Drug outlet' has the meaning given that term in ORS
689.005.
(3) 'Health professional regulatory board' has the meaning
given that term in ORS 676.160.
(4) 'Practitioner' has the meaning given that term in ORS
689.005.
(5) 'Prescription' has the meaning given that term in ORS
475.005.
(6) 'Prescription drug' has the meaning given that term in ORS
689.005. + }
SECTION 2. { + (1)(a) The Department of Human Services, in
consultation with the Prescription Monitoring Program Advisory
Commission, shall establish and maintain a prescription
monitoring program for monitoring and reporting prescription
drugs dispensed by pharmacies in Oregon that are classified in
schedules II through IV under the federal Controlled Substances
Act, 21 U.S.C. 811 and 812, as modified under ORS 475.035.
(b)(A) To fulfill the requirements of this subsection, the
department shall establish, maintain and operate an electronic
system to monitor and report drugs described in paragraph (a) of
this subsection that are dispensed by prescription.
(B) The system must operate and be accessible by practitioners
and pharmacies 24 hours a day, seven days a week.
(C) The department may contract with a state agency or private
entity to ensure the effective operation of the electronic
system.
(2) In consultation with the commission, the department shall
adopt rules for the operation of the electronic prescription
monitoring program established under subsection (1) of this
section, including but not limited to standards for:
(a) Reporting data;
(b) Providing maintenance, security and disclosure of data;
(c) Ensuring accuracy and completeness of data;
(d) Complying with the federal Health Insurance Portability and
Accountability Act of 1996 (P.L. 104-191) and regulations adopted
under it, including 45 C.F.R. parts 160 and 164, federal alcohol
and drug treatment confidentiality laws and regulations adopted
under those laws, including 42 C.F.R. part 2, and state health
and mental health confidentiality laws, including ORS 179.505,
192.517 and 192.518 to 192.529;
(e) Ensuring accurate identification of persons or entities
requesting information from the database;
(f) Accepting printed or nonelectronic reports from pharmacies
that do not have the capability to provide electronic reports;
and
(g) Notifying a patient, before or when a drug classified in
schedules II through IV is dispensed to the patient, about the
prescription monitoring program and the entry of the prescription
in the system.
(3) The department shall submit an annual report to the
commission regarding the prescription monitoring program
established under this section. + }
SECTION 3. { + (1) Not later than one week after dispensing a
prescription drug subject to the prescription monitoring program
established under section 2 of this 2009 Act, a pharmacy shall
electronically report to the Department of Human Services the:
(a) Name, address and date of birth of the patient;
(b) Identification of the pharmacy dispensing the prescription
drug;
(c) Identification of the practitioner who prescribed the drug;
(d) Identification of the prescription drug by a national drug
code number;
(e) Date of origin of the prescription;
(f) Date the drug was dispensed; and
(g) Quantity of drug dispensed.
(2) Notwithstanding subsection (1) of this section, the
department may not:
(a) Require the reporting of prescription drugs administered
directly to a patient or dispensed pursuant to ORS 127.800 to
127.897; or
(b) Collect or use Social Security numbers in the prescription
monitoring program.
(3) Upon receipt of the data reported pursuant to subsection
(1) of this section, the department shall record the data in the
electronic system operated pursuant to the prescription
monitoring program.
(4)(a) The department may grant a pharmacy a waiver of the
electronic submission requirement of subsection (1) of this
section for good cause as determined by the department. The
waiver shall state the format, method and frequency of the
alternate nonelectronic submissions from the pharmacy and the
duration of the waiver.
(b) As used in this subsection, 'good cause' includes financial
hardship.
(5) This section does not apply to pharmacies in institutions
as defined in ORS 179.010. + }
SECTION 4. { + (1)(a) Except as provided under subsection (2)
of this section, prescription monitoring information submitted
under section 3 of this 2009 Act to the prescription monitoring
program established in section 2 of this 2009 Act:
(A) Is protected health information under ORS 192.518 to
192.529.
(B) Is not subject to disclosure pursuant to ORS 192.410 to
192.505.
(b) Except as provided under subsection (2)(a)(D) of this
section, prescription monitoring information submitted under
section 3 of this 2009 Act to the prescription monitoring program
may not be used to evaluate a practitioner's professional
practice.
(2)(a) If a disclosure of prescription monitoring information
complies with the federal Health Insurance Portability and
Accountability Act of 1996 (P.L. 104-191) and regulations adopted
under it, including 45 C.F.R. parts 160 and 164, federal alcohol
and drug treatment confidentiality laws and regulations adopted
under those laws, including 42 C.F.R. part 2, and state health
and mental health confidentiality laws, including ORS 179.505,
192.517 and 192.518 to 192.529, the Department of Human Services
shall disclose the information:
(A) To a practitioner or pharmacist who certifies that the
requested information is for the purpose of evaluating the need
for or providing medical or pharmaceutical treatment for a
patient to whom the practitioner or pharmacist anticipates
providing, is providing or has provided care.
(B) To designated representatives of the department or any
vendor or contractor with whom the department has contracted to
establish or maintain the electronic system of the prescription
monitoring program.
(C) Pursuant to a valid court order based on probable cause and
issued at the request of a federal, state or local law
enforcement agency engaged in an authorized drug-related
investigation involving a person to whom the requested
information pertains.
(D) To a health professional regulatory board that certifies in
writing that the requested information is necessary for an
investigation related to licensure, renewal or disciplinary
action involving the applicant, licensee or registrant to whom
the requested information pertains.
(E) To a prescription monitoring program of another state if
the confidentiality, security and privacy standards of the
requesting state are determined by the department to be
equivalent to those of the department.
(b) The department may disclose information from the
prescription monitoring program that does not identify a patient,
practitioner or drug outlet:
(A) For educational, research or public health purposes; and
(B) To officials of the department who are conducting special
epidemiologic morbidity and mortality studies in accordance with
ORS 432.060 and rules adopted under ORS 431.110.
(c) The department shall disclose information relating to a
patient maintained in the electronic system operated pursuant to
the prescription monitoring program established under section 2
of this 2009 Act to that patient at no cost to the patient within
10 business days after the department receives a request from the
patient for the information.
(d)(A) A patient may request the department to correct any
information about the patient that is erroneous. The department
shall grant or deny a request to correct information within 10
business days after the department receives the request.
(B) If the department denies a patient's request to correct
information under this paragraph, or fails to grant a patient's
request to correct information under this paragraph within 10
business days after the department receives the request, the
patient may appeal the denial or failure to grant the request.
Upon receipt of an appeal under this subparagraph, the department
shall conduct a contested case hearing as provided in ORS chapter
183. Notwithstanding ORS 183.450, in the contested case hearing,
the department has the burden of establishing that the
information included in the prescription monitoring program is
correct.
(e) The information in the prescription monitoring program may
not be used for any commercial purpose.
(f) In accordance with ORS 192.518 to 192.529 and federal
privacy regulations, any person authorized to prescribe or
dispense a prescription drug and who is entitled to access a
patient's prescription monitoring information may discuss or
release the information to other health care providers involved
with the patient's care, in order to provide safe and appropriate
care coordination.
(3)(a) The department shall maintain records of the information
disclosed through the prescription monitoring program including,
but not limited to:
(A) The identity of each person who requests or receives
information from the program and the organization, if any, the
person represents;
(B) The information released to each person or organization;
and
(C) The date and time the information was requested and the
date and time the information was provided.
(b) Records maintained as required by this subsection may be
reviewed by the Prescription Monitoring Program Advisory
Commission.
(4) Information in the prescription monitoring program that
identifies an individual patient must be removed no later than
three years from the date the information is entered into the
program.
(5) The department shall notify the Attorney General and each
affected individual of an improper disclosure of information from
the prescription monitoring program.
(6)(a) If the department or a person or entity required to
report or authorized to receive or release controlled substance
prescription information under this section violates section 3, 4
or 5 of this 2009 Act, a person injured by the violation may
bring a civil action against the department, person or entity and
may recover damages in the amount of $1,000 or actual damages,
whichever is greater.
(b) Notwithstanding paragraph (a) of this subsection, the
department and a person or entity required to report or
authorized to receive or release controlled substance
prescription information under this section are immune from civil
liability for violations of section 3, 4 or 5 of this 2009 Act
unless the department, person or entity acts with malice,
criminal intent, gross negligence, recklessness or willful
intent.
(7) Nothing in sections 2 to 11 of this 2009 Act requires a
practitioner or pharmacist who prescribes or dispenses a
prescription drug to obtain information about a patient from the
prescription monitoring program. A practitioner or pharmacist who
prescribes or dispenses a prescription drug may not be held
liable for damages in any civil action on the basis that the
practitioner or pharmacist did or did not request or obtain
information from the prescription monitoring program. + }
SECTION 5. { + A pharmacist may not refuse to fill a valid
prescription solely because the pharmacist cannot receive patient
information from the prescription monitoring program established
under section 2 of this 2009 Act at the time the patient requests
that the prescription be filled. + }
SECTION 6. { + (1) In addition to any other penalty provided
by law, the Attorney General may impose a civil penalty not to
exceed $10,000 for each violation of section 3, 4 or 5 of this
2009 Act. Each improper release of information from the
prescription monitoring program in violation of section 4 of this
2009 Act is a separate violation.
(2) Civil penalties under this section shall be imposed as
provided in ORS 183.745.
(3) The Department of Justice may adopt rules as required to
carry out the provisions of this section.
(4) Penalties recovered under this section shall be paid into
the State Treasury and credited to the General Fund. + }
SECTION 7. { + The Department of Human Services shall report a
practitioner or pharmacist authorized to obtain controlled
substance prescription information from the prescription
monitoring system established under section 2 of this 2009 Act
who discloses or uses information obtained from the system in
violation of section 4 of this 2009 Act to the health
professional regulatory board responsible for the practitioner or
pharmacist. + }
SECTION 8. { + (1) As used in this section, 'board' means:
(a) The Oregon Medical Board;
(b) The Oregon Board of Dentistry;
(c) The Board of Naturopathic Examiners;
(d) The Oregon State Board of Nursing;
(e) The Oregon Board of Optometry; and
(f) The State Board of Pharmacy.
(2)(a) In addition to other licensing fees imposed by a board
on licensees, a board shall adopt rules imposing a fee of $25 per
year on each person licensed by the board who is authorized to
prescribe or dispense controlled substances. A board shall
collect the fee at the same time the board collects other
licensing fees imposed on licensees.
(b) A board shall retain 10 percent of the fees collected under
paragraph (a) of this subsection to cover the costs of accounting
and collection of the fees.
(c) On the first day of each calendar quarter, a board shall
transmit 90 percent of the fees collected under paragraph (a) of
this subsection during the preceding calendar quarter to the
Electronic Prescription Monitoring Fund established in section 11
of this 2009 Act. + }
SECTION 9. { + (1) The Prescription Monitoring Program
Advisory Commission is created for the purposes of:
(a) Studying issues related to the prescription monitoring
program established under section 2 of this 2009 Act;
(b) Reviewing the program's annual report and making
recommendations to the Department of Human Services regarding the
operation of the program; and
(c) Developing criteria that should be used to evaluate program
data.
(2) The commission shall consist of 11 members appointed by the
department as follows:
(a) A person nominated by the Pain Management Commission;
(b) A person who dispenses controlled substances nominated by
an association representing pharmacists;
(c) A practicing dentist nominated by an association
representing dentists;
(d) A practicing physician nominated by an association
representing physicians;
(e) A practicing doctor of osteopathy nominated by an
association representing osteopathic physicians and surgeons;
(f) A nurse authorized to prescribe controlled substances
nominated by an association representing nurses;
(g) A practicing naturopathic physician nominated by an
association representing naturopathic physicians;
(h) A practicing optometrist, nominated by an association
representing optometrists;
(i) A person nominated by the department from a division of the
department responsible for administering addiction services; and
(j) Two members of the public nominated by the department, one
of whom must be an expert in information technology. + }
SECTION 10. { + (1) The term of office of each member of the
Prescription Monitoring Program Advisory Commission is four
years, but a member serves at the pleasure of the Department of
Human Services. Before the expiration of the term of a member,
the department shall appoint a successor whose term begins on
July 1 next following. A member is eligible for reappointment. If
there is a vacancy for any cause, the department shall make an
appointment to become immediately effective.
(2) The commission shall elect one of its members to serve as
chairperson.
(3) The commission shall meet at least once annually at a time
and place specified by the chairperson of the commission. The
commission may meet at other times and places specified by the
call of the chairperson or of a majority of the members of the
commission.
(4) The commission may adopt rules necessary for the operation
of the commission.
(5) A majority of the members of the commission constitutes a
quorum for the transaction of business.
(6) Official action by the commission requires the approval of
a majority of the members of the commission.
(7) The department shall provide staff support to the
commission.
(8) Members of the commission are not entitled to compensation,
but may be reimbursed for actual and necessary travel and other
expenses incurred by them in the performance of their official
duties in the manner and amounts provided for in ORS 292.495.
Claims for expenses incurred in performing functions of the
commission shall be paid out of funds appropriated to the
department for that purpose.
(9) All agencies of state government, as defined in ORS
174.111, are directed to assist the commission in the performance
of its duties and, to the extent permitted by laws relating to
confidentiality, to furnish such information and advice as the
members of the commission consider necessary to perform their
duties. + }
SECTION 11. { + (1) The Electronic Prescription Monitoring
Fund is established in the State Treasury, separate and distinct
from the General Fund. The Electronic Prescription Monitoring
Fund consists of moneys transmitted to the fund under section 8
of this 2009 Act and any other moneys deposited in accordance
with law. Interest earned by the fund shall be credited to the
fund. Moneys in the fund are continuously appropriated to the
Department of Human Services for the purpose of carrying out the
provisions of sections 2 to 11 of this 2009 Act.
(2) The Department of Human Services may accept grants,
donations, gifts or moneys from any source for deposit into the
fund established by this section. + }
SECTION 12. { + Notwithstanding the term of office specified
by section 10 of this 2009 Act, the members first appointed to
the Prescription Monitoring Program Advisory Commission shall
determine by lot at the first meeting of the commission the
initial terms of office for commission members as follows:
(1) Three shall serve for a term ending July 1, 2010.
(2) Four shall serve for a term ending on July 1, 2011.
(3) Four shall serve for a term ending on July 1, 2012. + }
SECTION 13. { + (1) Sections 3 to 5 of this 2009 Act become
operative on July 1, 2010.
(2) The Department of Human Services may take any action before
the operative date in subsection (1) of this section that is
necessary to enable the department to exercise, on or after the
operative date in subsection (1) of this section, all of the
duties, functions and powers conferred on the department by
sections 3 to 5 of this 2009 Act. + }
SECTION 14. { + (1) If the Legislative Assembly is meeting in
special session in February 2010, the Department of Human
Services shall report to the Joint Committee on Ways and Means on
the implementation of the prescription monitoring program under
sections 2 to 11 of this 2009 Act. The report shall include, but
need not be limited to, the status of the electronic system
required by section 2 of this 2009 Act and the content of rules
adopted under section 2 of this 2009 Act.
(2) If the Legislative Assembly is not meeting in special
session in February 2010, the department shall submit the report
described in subsection (1) of this section to the Speaker of the
House of Representatives and the President of the Senate by
February 15, 2010. + }
SECTION 15. { + Notwithstanding any other law limiting
expenditures, the limitation on expenditures established by
section 2 (3), chapter ___, Oregon Laws 2009 (Enrolled Senate
Bill 5529), for the biennium beginning July 1, 2009, as the
maximum limit for payment of expenses for health services from
fees, moneys or other revenues, including Miscellaneous Receipts,
but excluding lottery funds and federal funds, collected or
received by the Department of Human Services, is increased by
$250,000 for the purpose of carrying out the provisions of
sections 2 to 11 of this 2009 Act. + }
SECTION 16. { + Notwithstanding any other law limiting
expenditures, the limitation on expenditures established by
section 4 (3), chapter ___, Oregon Laws 2009 (Enrolled Senate
Bill 5529), for the biennium beginning July 1, 2009, as the
maximum limit for payment of expenses from certain federal funds
collected or received by the Department of Human Services, is
increased by $10,000 for the purpose of carrying out the
provisions of sections 2 to 11 of this 2009 Act. + }
SECTION 17. { + 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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