BILL REQ. #: H-4286.2
State of Washington | 60th Legislature | 2008 Regular Session |
Read first time 01/15/08. Referred to Committee on Health Care & Wellness.
AN ACT Relating to prohibiting the sale and use of prescriber-identifiable prescription data for marketing or promotional purposes; amending RCW 42.56.350; adding a new chapter to Title 19 RCW; creating a new section; and prescribing penalties.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF WASHINGTON:
NEW SECTION. Sec. 1 (1) The legislature finds that:
(a) The state of Washington has a clear and long-standing interest
in maximizing the health and well-being of its residents and in
containing health care costs;
(b) To further its substantial interest in the health and
well-being of its residents and in containing health care costs, the
state of Washington has shown a strong commitment to evidence-based
care and cost-effective health purchasing. Washington state has been
most active in this regard with respect to prescription drug purchasing
focused on clinical and cost-effectiveness, including the Washington
evidence-based prescription drug program and the state preferred drug
list under RCW 70.14.050, the prescription drug purchasing consortium
under RCW 70.14.060, and both generic and therapeutic drug substitution
under chapter 69.41 RCW. In addition, the medicaid program is engaged
in numerous efforts to improve the quality of, and reduce variability
in, prescribing of pain management and mental health medications. The
state also aggressively seeks supplemental rebates to lower drug costs
in the medicaid program. The Washington state health technology
assessment program, established under chapter 70.14 RCW, is applying
the principles of evidence-based care and cost-effective purchasing to
the review of medical devices and procedures for state purchased health
care programs. Finally, the state is an active participant in the
Puget Sound health alliance, whose goal is to improve the quality and
transparency of health services provided across the public and private
sectors;
(c) Prescriber-identifiable prescription data shows details of
prescribers' drug use patterns. Using this data, pharmaceutical
manufacturers can track the prescribing habits of every prescriber in
Washington, allowing them to target their marketing efforts toward
those prescribers that they find would lead to increased prescriptions
and profitability;
(d) Health care providers in Washington who write prescriptions for
their patients have a strong interest in the integrity of the patient-provider relationship and a reasonable expectation that the information
in their prescriptions, including their own identity, will not be used
for purposes other than the filling and processing of the payment for
that prescription. The Washington chapter of the academy of family
practice, the Washington chapter of the academy of pediatrics, and the
Washington state medical association support a prohibition on the sale
or use of individual prescriber prescription data for marketing or
promotional purposes;
(e) The removal of the names and addresses of patients from
prescription drug data purchased by pharmaceutical manufacturers does
not completely protect the privacy of patients. Tracking treatment
history and prescriber identity can allow reidentification of patients,
and can result in marketing directed at convincing a prescriber to
change a particular patient's treatment;
(f) The physician data restriction program offered by the American
medical association is not an adequate remedy for Washington
physicians, because (i) many physicians do not know about the program;
(ii) many physicians do not receive the end-of-period notification for
renewing or canceling their participation; (iii) under the program,
physician-specific prescribing data can still be sold to data mining
companies even though it is not supposed to be provided to sales
representatives; and (iv) the American medical association could choose
to end the program at any time;
(g) In 2004, the pharmaceutical industry spent twenty-seven billion
dollars marketing pharmaceuticals in the United States. Marketing
programs are designed to increase sales, income, and profit. Progress
toward these goals can come at the expense of evidence-based care,
efforts to contain health care costs, and sometimes the health of
individual patients;
(h) Newer drugs on the market do not necessarily provide additional
benefits over older drugs but do add costs and as yet unknown side
effects. Marketing that results in prescribers using the newest drugs
results in prescribing drugs that are more likely to be subject to
federal food and drug administration "black box" warnings or withdrawal
from the market for safety reasons; and
(i) The sale of prescriber-identifiable prescription data runs
counter to Washington's strong commitment to both evidence-based care
and cost-effective health purchasing. Pharmaceutical marketers,
through their surveillance of prescription records that include
prescriber-identifiable data, are able to monitor and reward
prescribing practices that favor the financial interests of
pharmaceutical manufacturers over the interests of patients in
clinically effective and cost-effective care. This act is necessary to
realize the goals of the programs and activities undertaken by the
state of Washington to implement evidence-based care and cost-effective
health purchasing and to preserve the integrity of the patient-prescriber relationship.
(2) It is the intent of the legislature to improve the quality of
health care received by Washingtonians, further health care cost
containment, and protect the privacy of prescribing information, by
prohibiting conduct involving the sale and use of individual prescriber
prescription data for marketing or promotional purposes.
NEW SECTION. Sec. 2 The definitions in this section apply
throughout this chapter unless the context clearly requires otherwise.
(1) "Health care provider" has the same meaning as in RCW
48.43.005(16).
(2) "Health carrier" has the same meaning as in RCW 48.43.005(18).
(3) "Marketing" or "market" includes advertising, promotion, or any
activity that is intended to be used or is used to influence sales or
the market share of a prescription drug, influence the prescribing
behavior of an individual health care provider to promote a
prescription drug, market prescription drugs to patients, or evaluate
the effectiveness of a professional pharmaceutical detailing sales
force.
(4)(a) "Pharmaceutical manufacturer" means an entity that is
engaged in the production, preparation, propagation, compounding,
conversion, or processing of prescription drugs, either directly or
indirectly by extraction from substances of natural origin, or
independently by means of chemical synthesis, or by a combination of
extraction and chemical synthesis, or any entity engaged in the
packaging, repackaging, labeling, relabeling, or distribution of
prescription drugs, biologics, or medical devices.
(b) "Pharmaceutical manufacturer" does not include pharmacists or
pharmacies licensed under chapter 18.64 RCW or pharmacy operations of
any integrated delivery system undertaken for the benefit of patients
obtaining care through that system.
(5) "Pharmaceutical marketer" means a person, agent, or
representative who, while employed by or under contract to represent a
pharmaceutical manufacturer, engages in pharmaceutical promotional
activities, or other marketing of prescription drugs in this state to
any entity or person authorized to prescribe, dispense, or purchase
prescription drugs in this state.
(6) "Pharmacy" means any individual or entity licensed under
chapter 18.64 RCW.
(7) "Prescriber" means a health care provider authorized by law to
prescribe and administer prescription drugs in the course of
professional practice.
(8) "Promotion" or "promote" means any activity or product the
intention of which is to advertise or publicize a prescription drug,
including a brochure, media advertisement or announcement, poster, free
sample, detailing visit, or personal appearance.
(9) "Regulated records" means information or documentation from a
prescription written by a prescriber doing business in Washington or a
prescription dispensed in Washington.
NEW SECTION. Sec. 3 (1) Pharmaceutical marketers shall not
purchase, license, transfer, use, or sell regulated records that
include prescriber-identifiable data to market or promote a
prescription drug.
(2) This section does not restrict the licensure, transfer, use, or
sale of regulated records that include prescriber-identifiable data for
the purposes of:
(a) Activities related to filling a valid prescription, including
the dispensing of prescription medications to a patient or to the
patient's authorized representative; the transmission of prescription
information between an authorized prescriber and a pharmacy; the
transfer of prescription information between pharmacies; the transfer
of prescription records that may occur if pharmacy ownership is changed
or transferred; and pharmacy reimbursement;
(b) Formulary compliance;
(c) Care management related to the diagnosis, treatment, or
management of illness for a specific patient, including care management
educational communications provided to a patient about the patient's
health condition, adherence to a prescribed course of therapy, or other
information about the drug being dispensed, treatment options, or
clinical trials;
(d) Utilization review by a health care provider, the patient's
health carrier, or an agent of the provider or carrier;
(e) Health care research including, but not limited to,
postmarketing surveillance research, drug interaction research, drug
safety studies, and population-based public health research;
(f) Collection and analysis of prescription drug utilization data
for health care quality improvement purposes, including development of
evidence-based treatment guidelines or health care performance
effectiveness and efficiency measures, promoting compliance with
evidence-based treatment guidelines or health care performance
measures, and providing prescribers with information that details their
practices relative to their peers to encourage prescribing consistent
with evidence-based practice;
(g) Collection and dissemination of drug utilization data to
promote transparency in evaluating performance related to the health
care quality improvement measures included in (f) of this subsection;
(h) The transfer of prescription drug utilization data to and
through secure electronic health record or personal health record
systems;
(i) The collection and transmission of prescription information to
a Washington or federal law enforcement officer engaged in his or her
official duties as otherwise provided by law; or
(j) As otherwise expressly provided by law.
(3) This section does not prohibit the collection, use, transfer,
or sale of regulated records for marketing or promotion, organized by
medical specialty or otherwise, if the data does not identify a
prescriber, and there is no reasonable basis to believe that the data
provided could be used to identify a prescriber or a patient.
NEW SECTION. Sec. 4 Any person who knowingly fails to comply
with the requirements of this chapter or rules adopted pursuant to this
chapter by purchasing, licensing, transferring, using, or selling
regulated data in a manner not authorized by this chapter or its rules
shall be subject to an administrative penalty of not more than fifty
thousand dollars per violation, as assessed by the secretary of the
department of health. The office of the attorney general shall take
necessary action to enforce payment of penalties assessed under this
section.
NEW SECTION. Sec. 5 In addition to any other remedy provided by
law, the legislature finds that the practices covered by this chapter
are matters vitally affecting the public interest for the purpose of
applying the consumer protection act, chapter 19.86 RCW. A violation
of this chapter is not reasonable in relation to the development and
preservation of business and is an unfair or deceptive act in trade or
commerce and an unfair method of competition for the purpose of
applying the consumer protection act, chapter 19.86 RCW.
Sec. 6 RCW 42.56.350 and 2005 c 274 s 415 are each amended to
read as follows:
(1) The federal Social Security number of individuals governed
under chapter 18.130 RCW maintained in the files of the department of
health is exempt from disclosure under this chapter. The exemption in
this section does not apply to requests made directly to the department
from federal, state, and local agencies of government, and national and
state licensing, credentialing, investigatory, disciplinary, and
examination organizations.
(2) The current residential address and current residential
telephone number of a health care provider governed under chapter
18.130 RCW maintained in the files of the department are exempt from
disclosure under this chapter, if the provider requests that this
information be withheld from public inspection and copying, and
provides to the department of health an accurate alternate or business
address and business telephone number. The current residential address
and residential telephone number of a health care provider governed
under RCW 18.130.040 maintained in the files of the department of
health shall automatically be withheld from public inspection and
copying unless the provider specifically requests the information be
released, and except as provided for under RCW 42.56.070(9).
(3) Records held by an agency administering a state purchased
health care program, as defined in RCW 41.05.011(2), that include
prescription information containing prescriber-identifiable data that
could be used to identify a prescriber, are exempt from disclosure
under this chapter, except that the records shall be made available
upon request for the purposes expressed in section 3(2) of this act.
NEW SECTION. Sec. 7 Sections 1 through 5 of this act constitute
a new chapter in Title
NEW SECTION. Sec. 8 This act may be known and cited as the
prescription privacy and integrity act of 2008.