BILL REQ. #:  S-3746.2 

Read first time 01/14/08.   Referred to Committee on Health & Long-Term Care.

     AN ACT Relating to prohibiting the sale and use of prescriber-identifiable prescription data for marketing or promotional purposes absent affirmative authorization by the prescriber; amending RCW 42.56.350; adding a new chapter to Title 19 RCW; 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 well-being of its residents and in containing health care costs;
     (b) To further its substantial interest in the well-being of its residents and containing health care costs, the state of Washington has shown, through numerous legislative and executive branch activities, a strong commitment to evidence-based care and cost-effective health purchasing. Washington has been most active in this regard with respect to prescription drug purchasing focused on clinical and cost-effectiveness. The commitment is demonstrated through establishment of the Washington evidence-based prescription drug program and the state preferred drug list under RCW 70.14.050, establishment of 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) The sale of prescriber-identifiable prescription data without the consent of the prescriber runs counter to Washington's strong commitment to both evidence-based care and cost-effective health purchasing;
     (d) Prescriber-identifiable prescription data shows details of prescribers' drug use patterns. Pharmaceutical manufacturers purchase data from data mining companies that allow the manufacturers to track the prescribing habits of every prescriber in Washington. Pharmaceutical manufacturers can then target their marketing efforts toward those prescribers that they find would lead to increased prescriptions and profitability;
     (e) Health care providers in Washington who write prescriptions for their patients have a reasonable expectation that the information in that prescription, 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 commercial or marketing purposes absent explicit authorization from the prescriber;
     (f) 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;
     (g) 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;
     (h) 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;
     (i) 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
     (j) This act is necessary to protect prescriber privacy by limiting marketing to prescribers who choose to allow disclosure of their prescribing information, to promote the use of safe and clinically effective drugs, and to advance health care cost containment efforts for the state, consumers, and businesses.
     (2) It is the intent of the legislature to improve the quality of health care received by Washingtonians, protect the privacy of prescribers and prescribing information, and further health care cost containment, by prohibiting the sale and use of individual prescriber prescription data for commercial or marketing purposes absent explicit authorization by the prescriber as provided in section 3(1) of this act through establishment of the prescription drug information integrity program.

NEW SECTION.  Sec. 2   The definitions in this section apply throughout this chapter unless the context clearly requires otherwise.
     (1) "Department" means the department of health.
     (2) "Electronic transmission intermediary" means an entity that provides the infrastructure that connects the computer systems or other electronic devices used by health care providers, prescribers, pharmacies, health care facilities and pharmacy benefit managers, health carriers, third-party administrators, and agents and contractors of those persons, in order to facilitate the secure transmission of an individual's prescription drug order, refill, authorization request, claim, payment, or other prescription drug information.
     (3) "Health care facility" has the same meaning as in RCW 48.43.005(15).
     (4) "Health care provider" has same meaning as in RCW 48.43.005(16).
     (5) "Health carrier" has the same meaning as in RCW 48.43.005(18).
     (6) "Marketing" shall include 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 or evaluate 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.
     (7) "Pharmacy" means any individual or entity licensed under chapter 18.64 RCW.
     (8) "Prescriber" means a health care provider authorized by law to prescribe and administer prescription drugs in the course of professional practice.
     (9) "Program" means the prescription drug information integrity program established in this chapter.
     (10) "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.
     (11) "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)(a) The department, in consultation with the appropriate disciplinary boards or commissions, shall establish the prescription drug information integrity program to allow a prescriber to give consent for his or her identifying information to be used for the purposes described under subsection (2) of this section. The department shall provide an opportunity for a prescriber to indicate his or her consent on licensing application or renewal forms and shall provide a method for a prescriber to revoke his or her consent. The department may adopt rules to implement, administer, and enforce this program.
     (b) The department shall make available the list of prescribers who have consented to sharing their information. Entities that intend to use the information as authorized in this section shall review the list of participating prescribers at least every six months.
     (2) A health carrier, self-insured employer, electronic transmission intermediary, pharmacy, or other similar entity may use regulated records that include prescription information containing prescriber-identifiable data for marketing or promoting a prescription drug only if a prescriber has provided consent for the use of that data as provided in subsection (1)(a) of this section.
     (3) This section does not restrict the licensure, transfer, use, or sale of regulated records for the purposes of:
     (a) Pharmacy reimbursement;
     (b) Formulary compliance;
     (c) Care management related to the diagnosis, treatment, or management of illness for a specific patient;
     (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.
     (4) This section does not prohibit:
     (a) 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; or 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; or
     (b) The collection, use, transfer, or sale of prescriber data 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.

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 using, selling, or transferring 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. 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(3) of this act.

NEW SECTION.  Sec. 7   Sections 1 through 5 of this act constitute a new chapter in Title 19 RCW.