WSR 11-16-041

PERMANENT RULES

DEPARTMENT OF HEALTH


[ Filed July 27, 2011, 2:59 p.m. , effective August 27, 2011 ]


Effective Date of Rule: Thirty-one days after filing.

Purpose: Chapter 246-470 WAC establishes a prescription monitoring program (PMP). The rules are in response to 2007 legislation (ESSSB [E2SSB] 5930) which requires the department to implement a PMP, subject to available funding. The rule establishes definitions for terms used throughout the chapter, and requirements for adding additional drugs, dispenser data submission, accessing information from the program, confidentiality, and penalties and sanctions.

Statutory Authority for Adoption: Chapter 70.225 RCW, ESSSB [E2SSB] 5930 (chapter 259, Laws of 2007).

Adopted under notice filed as WSR 11-11-097 on May 18, 2011.

Changes Other than Editing from Proposed to Adopted Version: Two minor changes were made to address grammatical errors in WAC 246-470-050. Properly using the word "or" instead of "and."

A final cost-benefit analysis is available by contacting John Hilger, P.O. Box 47852, Olympia, WA 98504-7852, phone (360) 236-2929, fax (360) 236-2901, e-mail john.hilger@doh.wa.gov.

Number of Sections Adopted in Order to Comply with Federal Statute: New 0, Amended 0, Repealed 0; Federal Rules or Standards: New 0, Amended 0, Repealed 0; or Recently Enacted State Statutes: New 11, Amended 0, Repealed 0.

Number of Sections Adopted at Request of a Nongovernmental Entity: New 0, Amended 0, Repealed 0.

Number of Sections Adopted on the Agency's Own Initiative: New 0, Amended 0, Repealed 0.

Number of Sections Adopted in Order to Clarify, Streamline, or Reform Agency Procedures: New 0, Amended 0, Repealed 0.

Number of Sections Adopted Using Negotiated Rule Making: New 0, Amended 0, Repealed 0; Pilot Rule Making: New 0, Amended 0, Repealed 0; or Other Alternative Rule Making: New 11, Amended 0, Repealed 0.

Date Adopted: July 27, 2011.

Mary C. Selecky

Secretary

OTS-3924.5

Chapter 246-470 WAC

PRESCRIPTION MONITORING PROGRAM


NEW SECTION
WAC 246-470-001   Purpose.   These rules implement the prescription monitoring program, established by the legislature in chapter 70.225 RCW, as a means to promote the public health, safety, and welfare and to detect and prevent prescription drug abuse.

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NEW SECTION
WAC 246-470-010   Definitions.   The definitions in this section apply throughout this chapter unless the context clearly indicates otherwise:

(1) "Authentication" means information, electronic device, or certificate provided by the department or their designee to a data requestor to electronically access prescription monitoring information. The authentication may include, but is not limited to, a user name, password, or an identification electronic device or certificate.

(2) "Controlled substance" has the same meaning provided in RCW 69.50.101.

(3) "Department" means the department of health.

(4) "Dispenser" means a practitioner or pharmacy that delivers to the ultimate user a schedule II, III, IV, or V controlled substance or other drugs identified by the board of pharmacy in WAC 246-470-020, but does not include:

(a) A practitioner or other authorized person who only administers, as defined in RCW 69.41.010, a controlled substance or other drugs identified by the board of pharmacy in WAC 246-470-020; or

(b) A licensed wholesale distributor or manufacturer, as defined in chapter 18.64 RCW, of a controlled substance or other drugs identified by the board of pharmacy in WAC 246-470-020.

(5) "Patient" means the person or animal who is the ultimate user of a drug for whom a prescription is issued or for whom a drug is dispensed.

(6) "Patient address" means the current geographic location of the patient's residence. If the patient address is in care of another person or entity, the address of that person or entity is the "patient address" of record. When alternate addresses are possible, they must be recorded in the following order of preference:

(a) The geographical location of the residence, as would be identified when a telephone is used to place a 9-1-1 call; or

(b) An address as listed by the United States Postal Service; or

(c) The common name of the residence and town.

(7) "Pharmacist" means a person licensed to engage in the practice of pharmacy.

(8) "Prescriber" means a licensed health care professional with authority to prescribe controlled substances.

(9) "Prescription monitoring information" means information submitted to and maintained by the prescription monitoring program.

(10) "Program" means the prescription monitoring program established under chapter 70.225 RCW.

(11) "Valid photographic identification" means:

(a) A driver's license or instruction permit issued by any United States state or province of Canada. If the patient's driver's license has expired, the patient must also show a valid temporary driver's license with the expired card.

(b) A state identification card issued by any United States state or province of Canada.

(c) An official passport issued by any nation.

(d) A United States armed forces identification card issued to active duty, reserve, and retired personnel and the personnel's dependents.

(e) A merchant marine identification card issued by the United States Coast Guard.

(f) A state liquor control identification card. An official age identification card issued by the liquor control authority of any United States state or Canadian province.

(g) An enrollment card issued by the governing authority of a federally recognized Indian tribe located in Washington, if the enrollment card incorporates security features comparable to those implemented by the department of licensing for Washington drivers' licenses and are recognized by the liquor control board.

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NEW SECTION
WAC 246-470-020   Adding additional drugs to the program.   Pursuant to RCW 70.225.020, the board of pharmacy may add additional drugs to the list of drugs being monitored by the program by requesting the department amend these rules.

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NEW SECTION
WAC 246-470-030   Data submission requirements for dispensers.   A dispenser shall provide to the department the dispensing information required by RCW 70.225.020 and this section for all scheduled II, III, IV, and V controlled substances and for drugs identified by the board of pharmacy pursuant to WAC 246-470-020.

(1) Dispenser identification number. A dispenser shall acquire and maintain an identification number issued to dispensing pharmacies by the National Council for Prescription Drug Programs or a prescriber identifier issued to authorized prescribers of controlled substances by the Drug Enforcement Administration, United States Department of Justice.

(2) Submitting data. A dispenser shall submit data to the department electronically, not later than one week from the date of dispensing, and in the format required by the department.

(a) A dispenser shall submit for each dispensing the following information and any additional information required by the department:

(i) Patient identifier. A patient identifier is the unique identifier assigned to a particular patient by the dispenser;

(ii) Name of the patient for whom the prescription is ordered including first name, middle initial, last name, and generational suffixes, if any;

(iii) Patient date of birth;

(iv) Patient address;

(v) Patient gender;

(vi) Drug dispensed;

(vii) Date of dispensing;

(viii) Quantity and days supply dispensed;

(ix) Refill information;

(x) Prescriber identifier;

(xi) Prescription issued date;

(xii) Dispenser identifier;

(xiii) Prescription fill date and number;

(xiv) Source of payment indicated by one of the following:

(A) Private pay (cash, change, credit card, check);

(B) Medicaid;

(C) Medicare;

(D) Commercial insurance;

(E) Military installations and veterans affairs;

(F) Workers compensation;

(G) Indian nations;

(H) Other; and

(xv) When practicable, the name of person picking up or dropping off the prescription, as verified by valid photographic identification.

(b) A nonresident, licensed pharmacy that delivers controlled substances, as defined in RCW 18.64.360, is required to submit only the transactions for patients with a Washington state zip code.

(c) Data submission requirements do not apply to:

(i) The department of corrections or pharmacies operated by a county for the purpose of providing medications to offenders in state or county correctional institutions who are receiving pharmaceutical services from a state or county correctional institution's pharmacy. A state or county correctional institution's pharmacy must submit data to the program related to each offender's current prescriptions for controlled substances upon the offender's release from a state or county correctional institution.

(ii) Medications provided to patients receiving inpatient services provided at hospitals licensed under chapter 70.41 RCW or patients of such hospitals receiving services at the clinics, day surgery areas, or other settings within the hospital's license where the medications are administered in single doses; or medications provided to patients receiving outpatient services provided at ambulatory surgical facilities licensed under chapter 70.230 RCW.

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NEW SECTION
WAC 246-470-040   Patient access to information from the program.   A patient, or a patient's personal representative authorized under Title 11 RCW (Probate and trust law) and Title 7 RCW (Special proceedings and actions), may obtain a report listing all prescription monitoring information that pertains to the patient.

(1) Procedure for obtaining information. A patient or a patient's personal representative requesting information pursuant to this section shall submit a written request in person at the department, or at any other place specified by the department. The written request must be in a format established by the department.

(2) Identification required. The patient or the patient's personal representative must provide valid photographic identification prior to obtaining access to the information requested in this section.

(3) Proof of personal representation. Before obtaining access to the information pursuant to this section, a personal representative shall provide either:

(a) An official attested copy of the judicial order granting them authority to gain access to the health care records of the patient;

(b) In the case of parents of a minor child, a certified copy of the birth certificate of the minor child or other certified legal documents establishing parentage or guardianship; or

(c) In the case of persons holding power of attorney, the original document establishing the power of attorney.

The department may verify the patient authorization by any reasonable means prior to providing the information to the patient's personal representative.

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NEW SECTION
WAC 246-470-050   Pharmacist, prescriber or other health care practitioner access to information from the program.   A pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber may obtain prescription monitoring information relating to their patients, for the purpose of providing medical or pharmaceutical care.

(1) Registration for access. A pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber shall register with the department in order to receive an authentication to access the electronic system. The registration process shall be established by the department.

(2) Verification by the department. The department shall verify the authentication and identity of the pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber before allowing access to any prescription monitoring information.

(3) Procedure for accessing prescription information. A pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber may access information from the program electronically, using the authentication issued by the department.

(4) A pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber may alternately submit a written request via mail or facsimile transmission in a manner and format established by the department.

(5) Reporting lost or stolen authentication. If the authentication issued by the department is lost, missing, or the security of the authentication is compromised, the pharmacist, prescriber, or licensed health care practitioner authorized by a prescriber shall notify the department by telephone and in writing as soon as reasonably possible.

(6) All requests for, uses of, and disclosures of prescription monitoring information by authorized persons must be consistent with the program's mandate as outlined in RCW 70.225.040 and this chapter.

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NEW SECTION
WAC 246-470-060   Law enforcement, prosecutorial officials, coroners, and medical examiners' access to information from the program.   Local, state, or federal law enforcement officers and prosecutorial officials may obtain prescription monitoring information for a bona fide specific investigation involving a designated person. A local, state, or federal coroner or medical examiner may obtain prescription monitoring information for a bona fide specific investigation to determine cause of death.

(1) Registration for access. Local, state, or federal law enforcement officers, prosecutorial officials, coroners, and medical examiners shall register with the department in order to receive an authentication to access information from the program. The registration process shall be established by the department.

(2) Verification by the department. The department shall verify the authentication and identity of local, state, or federal law enforcement officers, prosecutorial officials, coroners, and medical examiners before allowing access to any prescription monitoring information.

(3) Procedure for accessing prescription information. Local, state, or federal law enforcement officers, prosecutorial officials, coroners and medical examiners may access information from the program electronically using the authentication issued by the department.

(4) Local, state, or federal law enforcement officers and prosecutorial officials shall electronically attest that the requested information is required for a bona fide specific investigation involving a designated person prior to accessing prescription monitoring information.

(5) Local, state, or federal coroner or medical examiners shall electronically attest that the requested information is required for a bona fide specific investigation to determine cause of death prior to accessing prescription monitoring information.

(6) Local, state, or federal law enforcement officers, prosecutorial officials, coroners and medical examiners may alternately submit a written request via mail or facsimile transmission in a format established by the department. The written request must contain an attestation that the requested information is required for a bona fide specific investigation involving a designated person or for a bona fide specific investigation to determine cause of death.

(7) Reporting lost or stolen authentication. If the authentication issued by the department is lost, missing, or the security of the authentication is compromised, the local, state, and federal law enforcement officers, prosecutorial officials, coroners or medical examiners shall notify the department by telephone and in writing as soon as reasonably possible.

(8) All requests for, uses of, and disclosures of prescription monitoring information by authorized persons must be consistent with the program's mandate as outlined in RCW 70.225.040 and this chapter.

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NEW SECTION
WAC 246-470-070   Other prescription monitoring program's access to information from the program.   Established prescription monitoring programs may obtain prescription monitoring information for requests from within their jurisdiction that do not violate the provisions of this chapter or chapter 70.225 RCW.

(1) The other prescription monitoring program must provide substantially similar protections for patient information as the protections provided in chapter 70.225 RCW.

(2) The department may share information with other prescription monitoring programs qualified under this section through a clearinghouse or prescription monitoring program information exchange that meets federal health care information privacy requirements.

(3) All requests for, uses of, and disclosures of prescription monitoring information by authorized persons must be consistent with the program's mandate as outlined in RCW 70.225.040 and this chapter.

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NEW SECTION
WAC 246-470-080   Access by public or private research entities to information from the program.   (1) The department may provide prescription monitoring information in a format established by the department to any public or private entity for statistical, research, or educational purposes.

(2) Before the department releases any requested information, the department shall remove information that could be used to identify individual patients, dispensers, prescribers, and persons who received prescriptions from dispensers.

(3) To obtain information from the program a public or private entity shall submit a request in a format established by the department.

(4) All requests for, uses of, and disclosures of prescription monitoring information by the requesting entity must be consistent with the program's mandate as outlined in RCW 70.225.040 and this chapter.

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NEW SECTION
WAC 246-470-090   Confidentiality.   Under RCW 70.225.040, prescription monitoring information is confidential, and maintained in compliance with chapter 70.02 RCW and federal health care information privacy requirements.

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NEW SECTION
WAC 246-470-100   Penalties and sanctions.   In addition to the penalties described in RCW 70.225.060, if the department determines a person has intentionally or knowingly used or disclosed prescription monitoring information in violation of chapter 70.225 RCW, the department may take action including, but not limited to:

(1) Terminating access to the program;

(2) Filing a complaint with appropriate health profession regulatory entities; or

(3) Reporting the violation to law enforcement.

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Washington State Code Reviser's Office