reglab/statecodes huggingface dataset:
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-50 - Prescription drug programs › Section 182-50-001 - Authority and purpose

Current through Register Vol. 24-14, July 15, 2024
RCW
				  41.05.021(1) (b)(iii) and
				  70.14.050 authorize the director
				  to establish an independent Washington state pharmacy and therapeutics
				  committee within the health care authority to evaluate available evidence of
				  the relative safety, efficacy and the effectiveness of prescription drugs
				  within a class of prescription drugs, in the development of an evidence-based
				  prescription drug program for participating state purchased health care
				  programs. This section requires the director to adopt rules governing
				  practitioner endorsement and use of the Washington preferred drug list
				  developed as part of the prescription drug program.
Statutory Authority:
					 RCW
					 41.05.160; 2004 1st sp.s. c 29 § 10.
					 04-06-021 (Order 03-02), §
											182-50-001, filed 2/23/04,
					 effective 3/25/04.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-50 - Prescription drug programs › Section 182-50-005 - Definitions

Current through Register Vol. 24-14, July 15, 2024
When used in this chapter:
(1) "Appointing authority" means the
				following people acting jointly: The director of the health care authority and
				the director of the department of labor and industries.
(2) "Committee" means the independent
				Washington state pharmacy and therapeutics committee created by
				RCW
				41.05.021(1)(b)(iii) and
				70.14.050. At the election of the
				health care authority, the committee may serve as the drug use review board
				provided for in WAC
				182-530-4000.
(3) "Drug" means the term as it is defined in
				RCW
				69.41.010.
(4) "Endorsing practitioner" means a
				practitioner who has notified the health care authority that he or she agrees
				to allow therapeutic interchange .
(5) "Practitioner" means a health care
				provider, except a veterinarian, as defined at
				RCW
				18.64.011.
(6) "Preferred drug" means a drug selected by
				the appointing authority for inclusion in the Washington preferred drug list
				used by applicable state agencies for state purchased health care
				programs.
(7) "Prescription" has
				the meaning set forth in
				RCW
				18.64.011.
(8) "Refill" means the continuation of
				therapy with the same drug, including the renewal of a previous prescription or
				adjustments in dosage.
(9) "State
				purchased health care" has the meaning set forth in
				RCW
				41.05.011.
(10) "Therapeutic interchange" means to
				dispense a preferred drug in place of a prescribed nonpreferred drug within the
				same therapeutic class listed on the Washington preferred drug list.
(11) "Washington preferred drug list" or
				"WPDL" means the list of drugs selected by the appointing authority to be used
				by applicable state agencies as the basis for the purchase of drugs in state
				purchased health care programs.
Statutory Authority:
					 RCW
					 41.05.160 and
					 69.41.180. 07-19-031 (Order
					 07-03), §
											182-50-005, filed 9/12/07,
					 effective 10/13/07. Statutory Authority:
					 RCW
					 41.05.160; 2004 1st sp.s. c 29 § 10.
					 04-06-021 (Order 03-02), §
											182-50-005, filed 2/23/04,
					 effective 3/25/04.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-50 - Prescription drug programs › Section 182-50-010 - Purpose of the pharmacy and therapeutics committee

Current through Register Vol. 24-14, July 15, 2024
The purpose of the committee is to evaluate the available
				  evidence of the relative safety, efficacy, and effectiveness of prescription
				  drugs within a class of prescription drugs and make recommendations to the
				  appointing authority for its deliberation in the development of the Washington
				  preferred drug list established in
				  RCW
				  70.14.050.
Statutory Authority:
					 RCW
					 41.05.160; 2004 1st sp.s. c 29 § 10.
					 04-06-021 (Order 03-02), §
											182-50-010, filed 2/23/04,
					 effective 3/25/04.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-50 - Prescription drug programs › Section 182-50-015 - Open Public Meetings Act and Administrative Procedure Act; exception as technical review committee

Current through Register Vol. 24-14, July 15, 2024
(1) Meetings of the
				pharmacy and therapeutics committee comply with the provisions of the Open
				Public Meetings Act,
				chapter
				42.30 RCW, and are subject
				to the provisions of the Administrative Procedure Act,
				chapter
				34.05 RCW, as
				applicable.
(2) The pharmacy and
				therapeutics committee constitutes a technical review committee created to
				facilitate the development, acquisition, or implementation of the Washington
				preferred drug list, for the purposes of state purchased health care under
				RCW
				41.05.026, and may hold an executive session
				in accordance with
				chapter
				42.30 RCW during any
				regular or special meeting to discuss information submitted in accordance with
				RCW
				41.05.026.
Statutory Authority:
					 RCW
					 41.05.160; 2004 1st sp.s. c 29 § 10.
					 04-06-021 (Order 03-02), §
											182-50-015, filed 2/23/04,
					 effective 3/25/04.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-50 - Prescription drug programs › Section 182-50-025 - Membership and qualifications of pharmacy and therapeutics committee

Current through Register Vol. 24-14, July 15, 2024
(1) The committee
				consists of no fewer than ten members appointed by the appointing
				authority.
(2) The appointing
				authority has the sole right to appoint committee members and may terminate
				appointment of any member at any time during the term.
(3) The appointing authority makes
				appointments to the committee from a pool of interested applicants. Interested
				people are provided an opportunity to submit applications to the appointing
				authority.
(4) Members enter into
				an agreement with the health care authority at the time of their appointment to
				the committee and act in accordance with all of its terms and conditions.
				Failure to do so may result in termination of the appointment.
(5) The membership composition at all times
				is consistent with applicable federal requirements for its drug utilization
				review board under the federal Social Security Act,
				Title
				19 Sec. 1927 and the
				requirements of the health care authority. Pharmacists and physicians each
				represent at least thirty-one percent, but no more than fifty-one percent of
				committee membership respectively.
(6) Members must be actively practicing in
				their clinical area of expertise throughout the entire term of their
				appointments.
(7) Members must have
				knowledge and expertise in one or more of the following:
(a) Clinically appropriate prescribing of
				covered outpatient drugs;
(b)
				Clinically appropriate dispensing and monitoring of covered outpatient
				drugs;
(c) Drug use
				review;
(d) Medical quality
				assurance;
(e) Disease state
				management; or
(f) Evidence-based
				medicine.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-50 - Prescription drug programs › Section 182-50-030 - Period of appointment

Current through Register Vol. 24-14, July 15, 2024
(1) Members are
				appointed to a term of three years and serve until a successor is appointed. A
				member may be reappointed to one additional three-year term for a total of six
				years. One year after the end of a six-year term, a person is eligible for
				appointment to one additional three-year term.
(2) Committee members serve staggered
				three-year terms. Of the initial appointees, in order to provide for staggered
				terms, some members may be appointed initially for less than three years. If
				the initial appointment is for less than twenty-four months, that period of
				time is not counted toward the limitation of years of appointment described in
				subsection (1) of this section.
(3)
				Vacancies on the committee will be filled for the balance of the unexpired term
				from nominee lists for the appropriate committee category as provided under WAC
				182-50-025.
(4) Members of the committee are compensated
				for participation in the work of the committee in accordance with a personal
				services contract executed after appointment and prior to commencement of
				activities related to the work of the committee.
Statutory Authority:
					 RCW
					 41.05.160; 2004 1st sp.s. c 29 § 10.
					 04-06-021 (Order 03-02), §
											182-50-030, filed 2/23/04,
					 effective 3/25/04.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-50 - Prescription drug programs › Section 182-50-035 - Duties

Current through Register Vol. 24-14, July 15, 2024
Committee members:
(1) Select a chair and a vice-chair from
				among the committee membership.
(2)
				Meet at least quarterly and may meet at other times at the discretion of the
				chair.
(3) Adopt a plan of
				operation that sets forth the policies and procedures established by the
				committee to develop an evidence-based prescription drug program as authorized
				by state law for approval by the appointing authority.
(4) Operate according to the plan of
				operation as approved by the appointing authority.
Statutory Authority:
					 RCW
					 41.05.160; 2004 1st sp.s. c 29 § 10.
					 04-06-021 (Order 03-02), §
											182-50-035, filed 2/23/04,
					 effective 3/25/04.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-50 - Prescription drug programs › Section 182-50-200 - Endorsing practitioner therapeutic interchange program; effect of practitioner's endorsing status; dispense as written instructions

Current through Register Vol. 24-14, July 15, 2024
(1) When filling
				prescriptions for participating state purchased health care programs,
				pharmacists must make a therapeutic interchange if the prescription is
				prescribed by an endorsing practitioner except:
(a) If the endorsing practitioner indicates
				"dispense as written" on the nonpreferred prescription;
(b) If the prescription is a refill of an
				antipsychotic, anti-depressant, antiepileptic, chemotherapy, antiretroviral,
				immunosuppressive drug, or an immuno-modulator/antiviral treatment for
				hepatitis C ; or
(c) If the
				pharmacy and therapeutics committee has determined that therapeutic interchange
				is not clinically appropriate for a specific drug or drug class on the
				Washington preferred drug list.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › Section 182-51-0050 - Authority and purpose

Current through Register Vol. 24-14, July 15, 2024
(1) Under the
				authority of chapter 43.71C RCW, this chapter implements the Washington drug
				price transparency program.
(2) The
				purpose of the Washington drug price transparency program is to improve
				transparency relating to the cost and price of prescription drugs to provide
				accountability to the state for rising drug costs and a consumer's ability to
				afford prescription drugs.
(3) The
				authority publishes a data submission guide to the authority's website,
				detailing the data elements to report as required by chapter 43.71C RCW, and
				how to submit the data.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › Section 182-51-0100 - Definitions

Current through Register Vol. 24-14, July 15, 2024
For the purposes of this chapter:
(1) "Authority" means the health care
				authority.
(2) "Calendar days"
				means the same as in WAC
				182-526-0010.
(3) "Calendar year" means the period from
				January 1st to December 31st of each year.
(4) "Confidential information" means
				information collected by the authority according to
				RCW
				43.71C.020 through
				43.71C.080,
				which is not subject to public disclosure under chapter 42.56 RCW and must be
				held confidential by all data recipients, according to WAC
				182-51-0900.
(5) "Course of
				treatment" means the duration of the actual administration of a drug to treat a
				condition.
(6) "Covered drug" means
				any prescription drug that:
(a) A covered
				manufacturer intends to introduce to market at a wholesale acquisition cost of
				$10,000 or more for a course of treatment lasting less than one month or a
				30-day supply, whichever period is longer; or
(b) Meets all of the following:
(i) Has been introduced to market;
(ii) Is manufactured by a covered
				manufacturer; and
(iii) Has a
				wholesale acquisition cost of more than $100 for a course of treatment lasting
				less than one month or a 30-day supply, and, taking into account only price
				increases that take effect on or after October 1, 2019, the manufacturer
				increases the wholesale acquisition cost such that:
(A) The new wholesale acquisition cost is 20
				percent higher than the wholesale acquisition cost on the same day of the
				month, 12 months before the date of the proposed increase; or
(B) The new wholesale acquisition cost is 50
				percent higher than the wholesale acquisition cost on the same day of the
				month, 36 months before the date of the proposed
				increase.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-0200 - Reporting entity registration

Current through Register Vol. 24-14, July 15, 2024
(1)
				  A reporting entity must register with the authority and provide the required
				  contact information as defined in the applicable data submission guide.
				  Reregistration is required only if the contact information previously provided
				  has changed.
(2) It is the
				  responsibility of the reporting entity to maintain current and accurate contact
				  information with the authority.
(3)
				  Failure to register and provide or maintain accurate contact information with
				  the authority may result in a reporting entity's inability to submit required
				  data in compliance with this chapter.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-0300 - Health carriers-Cost utilization data reporting

Current through Register Vol. 24-14, July 15, 2024
(1) No later than October 16, 2020, a health
				  carrier must submit to the authority the prescription drug cost and utilization
				  data for calendar years 2018 and 2019, for each health plan it offered in
				  Washington state in calendar years 2018 and 2019, following the guidelines set
				  in the authority's applicable data submission guide.
(2) Beginning October 1, 2021, and no later
				  than October 1st annually thereafter, a health carrier must submit to the
				  authority the prescription drug cost and utilization data for the previous
				  calendar year for each health plan it offered in Washington state, following
				  the guidelines set in the authority's applicable data submission
				  guide.
(3) A carrier may
				  voluntarily submit the data described in subsection (1) of this section for
				  other health plans it administers such as employer-sponsored, self-funded
				  health plans; Taft-Hartley trust health plans; worker's compensation plans;
				  medicare Part D plans; medicare advantage plans; or medicaid managed care
				  plans.
(4) The authority may assess
				  fines for not complying with the requirements in this section. See WAC
				  182-51-1100.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-0400 - Pharmacy benefit managers-Data reporting

Current through Register Vol. 24-14, July 15, 2024
(1) No later than March 1st of each year, a
				  pharmacy benefit manager must submit to the authority all data specified in
				  RCW
				  43.71C.030, following the guidelines set in
				  the authority's applicable data submission guide.
(2) The authority may examine or audit a
				  pharmacy benefit manager's financial records to ensure the information
				  submitted under this section is accurate. Information the authority acquires in
				  an examination of financial records according to this subsection is treated as
				  proprietary and confidential. The information collected according to this
				  subsection is not subject to public disclosure under chapter 42.56
				  RCW.
(3) A pharmacy benefit manager
				  may voluntarily submit the data described in subsection (1) of this section for
				  other health plans it administers such as employer-sponsored, self-funded
				  health plans; Taft-Hartley trust health plans; worker's compensation plans;
				  medicare Part D plans; medicare advantage plans; or medicaid managed care
				  plans.
(4) The information
				  submitted according to this section is not subject to public disclosure under
				  chapter 42.56 RCW.
(5) The agency
				  may assess fines for not complying with the requirements in this section. See
				  WAC 182-51-1100.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-0500 - Pharmacy benefit managers-Compliance

Current through Register Vol. 24-14, July 15, 2024
(1) No later than March 1st of each year,
				  each pharmacy benefit manager must file with the authority an attestation in
				  the format required by the authority for the preceding calendar year, stating
				  that the pharmacy benefit manager is in compliance with this chapter.
(2) A pharmacy benefit manager must not cause
				  or knowingly permit the use of any advertisement, promotion, solicitation,
				  representation, proposal, or offer that is untrue, deceptive, or
				  misleading.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-0600 - Manufacturers-Data and price reporting

Current through Register Vol. 24-14, July 15, 2024
(1)
				  On or before December 31, 2020, a covered manufacturer must submit to the
				  authority all data specified in
				  RCW
				  43.71C.050 and
				  43.71C.070,
				  following the guidelines set in the authority's applicable data submission
				  guide for each new covered drug introduced to market, or a covered drug that
				  had a qualifying price increase between and including October 1, 2019, and
				  October 15, 2020.
(2) Beginning
				  October 16, 2020, a covered manufacturer must submit to the authority all data
				  specified in
				  RCW
				  43.71C.050 and
				  43.71C.070,
				  following the guidelines set in the authority's applicable data submission
				  guide, for each covered drug as follows:
(a)
				  Sixty days in advance of a qualifying price increase for a covered drug already
				  introduced to market; or
(b) Within
				  30 days of a new covered drug introduced to market.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-0700 - Manufacturers-Notice of new drug applications and biologic license applications

Current through Register Vol. 24-14, July 15, 2024
(1) On or before
				  December 31, 2020, a manufacturer must submit to the authority all data
				  specified in
				  RCW
				  43.71C.060(1), following the
				  guidelines set in the authority's applicable data submission guide for all new
				  drug applications or biologic license applications for pipeline drugs submitted
				  on or after October 1, 2019, through October 15, 2020, for which the
				  manufacturer has received an FDA approval date.
(2) Beginning October 16, 2020, a
				  manufacturer must submit to the authority all data specified in RCW
				  43.71C.-060(1), following the guidelines set in the authority's applicable data
				  submission guide for all new drug applications or biologic license applications
				  for pipeline drugs submitted on or after October 16, 2020, within sixty
				  calendar days of the manufacturer receiving the FDA approval date.
(3) The authority considers fifty thousand
				  dollars per biennium to be a significant impact on state expenditures.
				  Reporting entities may anticipate a request for additional information per
				  RCW
				  43.71C.060(3) from the
				  authority for products expected to exceed fifty thousand dollars per biennium.
				  To improve efficiency in reporting, manufacturers who submit a new drug
				  application or a biologics license application for a pipeline drug or a
				  biologics license application for a biological product that is expected to cost
				  the state more than fifty thousand dollars per biennium may submit the data
				  elements in
				  RCW
				  43.71C.060(3) at the same
				  time they submit the notice of the new drug application.
(4) A manufacturer may limit the information
				  reported according to this section to information that is in the public domain
				  or publicly reported.
(5) The
				  agency may assess fines for not complying with the requirements in this
				  section. See WAC 182-51-1100.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-0800 - Pharmacy services administrative organizations-Data reporting

Current through Register Vol. 24-14, July 15, 2024
(1) No later than
				  October 16, 2020, and October 1st of each year thereafter, a pharmacy services
				  administrative organization representing a pharmacy or pharmacy chain in
				  Washington state must submit to the authority the data specified in
				  RCW
				  43.71C.080 following the guidelines set in
				  the authority's applicable data submission guide.
(2) Any pharmacy services administrative
				  organization whose revenue is generated from flat service fees not connected to
				  drug prices or volume, and paid by the pharmacy, is exempt from reporting,
				  subject to audit by the authority. These organizations must petition the
				  authority for exemption from the reporting requirements according to the
				  frequency listed and the formatting guidelines in the authority's applicable
				  data submission guide.
(3) The
				  authority may assess fines for not complying with the requirements in this
				  section. See WAC 182-51-1100.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-0900 - Data confidentiality

Current through Register Vol. 24-14, July 15, 2024
(1) The
				  authority provides data only after the data recipient, as defined by this
				  chapter, has signed a nondisclosure agreement. The authority may prohibit
				  access to or use of the data by a data recipient who violates the nondisclosure
				  agreement.
(2) Data recipients must
				  keep data confidential by:
(a) Accessing,
				  using, and disclosing information only in accordance with this section and
				  consistent with applicable statutes, regulations, and policies;
(b) Having a public policy purpose to access
				  and use the confidential information according to chapter 43.71C RCW;
(c) Protecting all confidential information
				  against unauthorized use, access, disclosure, or loss by employing reasonable
				  security measures, including physically securing any computers, documents, or
				  other media containing confidential information and viewing confidential
				  information only on secure workstations in nonpublic areas;
(d) Destroying all confidential information
				  when it is no longer needed to perform authorized activities; and
(e) Adhering to the confidentiality
				  requirements in this section after the data recipient is no longer an
				  authorized data recipient under
				  RCW
				  43.71C.100.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › DATA REPORTING, NOTICES, AND CONFIDENTIALITY › Section 182-51-1000 - Data submission guides

Current through Register Vol. 24-14, July 15, 2024
(1) All
				  data and data files must be submitted to the authority in accordance with the
				  requirements in this chapter and the respective data submission guide for the
				  respective reporting period. Data submission guides are located on the
				  authority's website.
(2) The
				  authority develops data submission guides and has final approval authority over
				  them. The authority provides reporting entities the opportunity to comment on
				  changes to data requirements in the applicable data submission guide, at least
				  thirty days before the effective date of the change.
(3) At its discretion, the authority may
				  grant reporting entities an extension to comply with any changes the authority
				  makes to the data submission guides. Reporting entities must request extensions
				  in accordance with WAC 182-51-1200.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › ENFORCEMENT › Section 182-51-1100 - Authority to assess fines

Current through Register Vol. 24-14, July 15, 2024
(1)
										RCW
				  43.71C.090 allows the authority to assess a
				  fine of up to one thousand dollars per day for failure to comply with the
				  requirements of
				  RCW
				  43.71C.020 through
				  43.71C.080
				  and the requirements of this chapter. See WAC 182-51-1300 for fines for failing
				  to comply with reporting requirements and WAC 182-51-1400 for the amount of
				  fines based on culpability.
(2) The
				  authority may grant an extension of time to a reporting requirement deadline
				  under WAC 182-51-1200.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › ENFORCEMENT › Section 182-51-1200 - Extension of deadlines

Current through Register Vol. 24-14, July 15, 2024
(1) The authority
				  may grant:
(a) An extension of time to a
				  reporting requirement deadline; or
(b) Permission to correct a previously
				  submitted and accepted report.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › ENFORCEMENT › Section 182-51-1300 - Fines for failure to comply with reporting requirements

Current through Register Vol. 24-14, July 15, 2024
(1) The authority may assess fines for
				  failure to comply with the general reporting requirements of this chapter
				  including, but not limited to, failing to report data or reporting erroneous or
				  inaccurate data.
(2) Unless the
				  authority has approved an extension or has received a request to correct
				  previously submitted data, the authority may assess a fine for failure to
				  comply with general reporting requirements contained in chapter 43.71C RCW and
				  this chapter including, but not limited to, the following:
(a) Failure to timely submit required data
				  files; or
(b) Failure to accurately
				  submit all data elements.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › ENFORCEMENT › Section 182-51-1400 - Amount of fines based on culpability

Current through Register Vol. 24-14, July 15, 2024
(1) In determining the amount of any fine,
				  the authority considers the level of culpability associated with the violation.
				  The levels of culpability, in the order of least severe to most severe, are as
				  follows:
(a)
Did not know.
The
				  reporting entity did not know and by exercising reasonable diligence, could not
				  have known the violation had occurred.
(b)
Reasonable cause.
The
				  reporting entity knew, or by exercising diligence should have known, that the
				  violation had taken place, but the reporting entity did not act with willful
				  neglect.
(c)
Willful neglect
				  - Corrected.
The violation was due to the reporting entity's intentional
				  failure or reckless indifference, and the violation was corrected within thirty
				  calendar days from the date the reporting entity knew or with reasonable
				  diligence should have known of the violation.
(d)
Willful neglect -
				  Uncorrected.
The violation was due to the reporting entity's intentional
				  failure or reckless indifference, and the violation was not corrected within
				  thirty calendar days from the date the reporting entity knew or with reasonable
				  diligence should have known of the violation.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › ENFORCEMENT › Section 182-51-1500 - Preliminary notice of violation and fine(s)

Current through Register Vol. 24-14, July 15, 2024
(1) Upon failing to comply with a reporting
				  requirement in this chapter, the authority first issues a warning notice to a
				  reporting entity. The authority sends the warning notice to the reporting
				  entity's last known email or physical address. The warning notice describes the
				  failure to comply with the requirements of this chapter and gives the reporting
				  entity thirty days to become compliant or request an extension of time to
				  report the required data according to WAC 182-51-1200(2).
(2) When a reporting entity fails to comply
				  with reporting requirement(s) after receiving a warning notice, the authority
				  may assess a fine(s) as established in WAC 182-51-1400. The authority mails a
				  preliminary notice of violation and fine(s) to the reporting entity's last
				  known address by certified mail, return receipt requested.
(3) The preliminary notice of violation and
				  fine(s) includes the following information:
(a) The specific reasons and criteria that
				  support the imposition of the assessed fine(s);
(b) The legal authority that supports the
				  imposition of a fine or fines;
(c)
				  The amount of the fine(s) as of the date of the preliminary notice of violation
				  and fine(s);
(d) Notice that fines
				  will continue to accrue at the assessed daily rate, per WAC 182-51-1400, until
				  the reporting entity either complies with the reporting requirements or settles
				  through an informal dispute resolution conference; and
(e) An explanation of the reporting entity's
				  right to request an informal dispute resolution conference under WAC
				  182-51-1700.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › ENFORCEMENT › Section 182-51-1600 - Process to appeal determination of a violation and assessed fines

Current through Register Vol. 24-14, July 15, 2024
(1) Each reporting
				  entity to whom the authority issues a preliminary notice of a violation and
				  fine(s) may request an informal dispute resolution conference under WAC
				  182-51-1700.
(2) If the reporting
				  entity requests an informal dispute resolution conference under WAC
				  182-51-1700, the reporting entity must complete the informal dispute resolution
				  process before requesting an administrative hearing.
(3) In lieu of an informal dispute resolution
				  conference, the reporting entity may request a formal appeal under WAC
				  182-51-1800 in writing, in a manner that provides proof of receipt, within 28
				  calendar days after receipt of the preliminary notice of violation and fine(s).
				  Upon receipt of the reporting entity's request, the authority issues a final
				  notice of violation and fine(s) with an explanation of the reporting entity's
				  administrative hearing rights under WAC 182-51-1800.
(4) If the reporting entity does not request
				  an informal dispute resolution conference or formal appeal within 28 calendar
				  days after receipt of the preliminary notice of violation and fine(s), the
				  authority issues a final notice of violation with an explanation of the
				  reporting entity's administrative hearing rights under WAC
				  182-51-1800.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › ENFORCEMENT › Section 182-51-1700 - Informal dispute resolution prior to a hearing

Current through Register Vol. 24-14, July 15, 2024
(1) A reporting entity may informally dispute
				  the authority's preliminary determination of a violation under this
				  chapter.
(2) A reporting entity
				  must submit a request for an informal dispute resolution conference to the
				  authority in writing, in a manner that provides proof of receipt, within
				  twenty-eight calendar days after receipt of the preliminary notice of violation
				  and fine(s).
(3) Requests should
				  specify:
(a) The name of the reporting entity
				  requesting the informal dispute resolution conference and the reporting
				  entity's, or representative's, mailing address, telephone number, and email
				  address (if available);
(b) The
				  items, facts, or conclusions in the preliminary notice of violation being
				  contested; and
(c) The basis for
				  contesting the authority's action, including any mitigating factors upon which
				  the reporting entity relies and the outcome the reporting entity is
				  seeking.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-51 - Drug pricing Price Transparency Program › ENFORCEMENT › Section 182-51-1800 - Administrative hearing (formal appeal) right

Current through Register Vol. 24-14, July 15, 2024
A reporting entity has a right to an administrative
					 hearing (formal appeal), and any resulting appeals process available under
					 chapters 34.05 RCW and 182-526 WAC, if the authority assesses a final notice of
					 violation and fine(s) against the reporting entity under any section of chapter
					 43.71C RCW and this chapter.
See WAC 182-526-0203.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0005 - Prescription drug affordability board-Purpose

Current through Register Vol. 24-14, July 15, 2024
The prescription drug affordability board conducts reviews of
				  drug prices, performs drug affordability reviews, and sets upper payment limits
				  for prescription drugs.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0015 - Prescription drug affordability board-Board members

Current through Register Vol. 24-14, July 15, 2024
(1) The
				prescription drug affordability board has five governor-appointed members with
				expertise in health care economics or clinical medicine. Once appointed, board
				members serve a five-year term.
(2)
				The governor may reappoint board members for additional terms.
(3) Board members cannot be an employee of, a
				board member of, or a consultant to any of the following:
(a) Prescription drug manufacturer;
(b) Pharmacy benefit manager;
(c) Health carrier;
(d) Prescription drug wholesale distributor;
				or
(e) Trade association related to
				(a) through (d) of this subsection.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0020 - Prescription drug affordability board-Procedures

Current through Register Vol. 24-14, July 15, 2024
(1) The board
				determines by member vote who will be the board chair and vice chair.
(2) The board chair remains as the chair for
				the duration of their term unless there are violations as stated in WAC
				182-52-0015(4).
(3) The board chair may choose to step down
				from their chair responsibilities and can continue to be an active board
				member.
(4) In the absence of the
				board chair, the vice chair acts in their place for that meeting.
(5) If board member vacancies exist, business
				continues as necessary with the remaining board members, as long as a quorum
				exists.
(6) A simple majority of
				the board's membership constitutes a quorum for the purpose of conducting
				business. If only three board members are present for a vote, the vote must be
				unanimous in order to pass.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0025 - Prescription drug affordability board-Meetings

Current through Register Vol. 24-14, July 15, 2024
(1) The board meets
				at least once annually, and additionally as defined by board policy.
(2) All board meetings must be open and
				public, except that the board may hold executive sessions to the extent
				permitted by chapter 42.30 RCW.
(a) Before
				convening an executive session, the board chair must publicly announce the
				purpose for excluding the public from the executive session.
(b) The board chair must announce the
				executive session place, date, and time.
(c) The executive session may be extended or
				have the date and time changed by announcement from the board chair.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0030 - Prescription drug affordability board-Advisory groups-Purpose, participation, application process, and operations

Current through Register Vol. 24-14, July 15, 2024
(1) The
				prescription drug affordability board advisory groups provide stakeholder input
				to the board regarding the affordability of prescription drugs.
(2) Utilizing administrative support from the
				authority, the board will establish advisory groups consisting of relevant
				stakeholders and subject matter experts for each drug selected for a drug
				affordability review conducted by the board.
(a) Advisory groups will consist of patients
				and patient advocates for the condition treated by the drug and one
				representative of the prescription drug industry. Additional group members, as
				selected by the board may include, but are not limited to, relevant
				stakeholders and experts in the following subject matters:
(i) The pharmaceutical business
				model;
(ii) Supply chain business
				model;
(iii) The practice of
				medicine or clinical training;
(iv)
				Health care consumer or patient perspectives;
(v) Health care cost trends and
				drivers;
(vi) Clinical and health
				services research;
(vii) The
				state's health care marketplace; or
(viii) Health care provider who specializes
				in treating the condition for the drug being reviewed.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0035 - Prescription drug affordability board-Review of drug prices

Current through Register Vol. 24-14, July 15, 2024
(1) By June 30th of
				each year, using data considered relevant by the board, the board must identify
				legend drugs and biologics that:
(a) Have been
				on the market for at least seven years;
(b) Are dispensed at a retail, specialty, or
				mail-order pharmacy; and
(c) Are
				not designated by the FDA under
				21 U.S.C. Sec.
				360bb as a drug solely for the treatment of a
				rare disease or condition.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0040 - Prescription drug affordability board-Affordability review requirements

Current through Register Vol. 24-14, July 15, 2024
(1) The board may
				choose to conduct an affordability review of up to 24 legend drugs or biologics
				per year and consider the following:
(a) The
				class of the prescription drug and whether any therapeutically equivalent
				prescription drugs are available for sale;
(b) Input from relevant advisory groups as
				listed in this chapter; and
(c) The
				out-of-pocket cost for the drug.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0045 - Prescription drug affordability board-Drug publication and conducting affordability reviews

Current through Register Vol. 24-14, July 15, 2024
Drugs selected for an affordability review are published on
				  the board's website before initiating the affordability review.
(1) When conducting an affordability review,
				the board will consider:
(a) The relevant
				factors contributing to the price paid for the prescription drug, including the
				wholesale acquisition cost, discounts, rebates, and other price
				concessions;
(b) The average
				out-of-pocket cost for the drug;
(c) The effect of the price on consumers'
				access to the drug in the state;
(d) Orphan drug status;
(e) The dollar value and accessibility of
				patient assistance programs offered by the manufacturer for the drug;
(f) The price and availability of therapeutic
				alternatives;
(g) Input from:
(i) Patients affected by the condition or
				disease treated by the drug; and
(ii) Individuals with medical or scientific
				expertise related to the condition or disease treated by the drug;
(h) Any other information the drug
				manufacturer or other relevant entity chooses to provide; and
(i) The impact of pharmacy benefit manager
				policies on the price consumers pay for the drug.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0050 - Prescription drug affordability board-Data and confidentiality

Current through Register Vol. 24-14, July 15, 2024
(1) For the purpose
				of reviewing drug prices and conducting affordability reviews, the board (as
				established in chapter 70.405 RCW) and the health care cost transparency board
				(established in chapter 70.390 RCW) may access all data collected under
				RCW
				43.71C.020 through
				43.71C.080 and any analysis
				prepared by the authority.
(2)
				Advisory group members may not access or review any confidential
				information.
(3) The information
				collected by the board pursuant to
				RCW
				70.405.040 is not subject to public
				disclosure under chapter 42.56 RCW.
(4) The authority provides data only after
				the data recipient, as defined by this chapter, has signed a nondisclosure
				agreement. The authority may prohibit access to or use of the data by a data
				recipient who violates the nondisclosure agreement.
(5) Data recipients must keep data
				confidential by:
(a) Accessing, using, and
				disclosing information only in accordance with this section and consistent with
				applicable statutes, regulations, and policies;
(b) Having a public policy purpose to access
				and use the confidential information according to chapter 70.405 RCW;
(c) Protecting all confidential information
				against unauthorized use, access, disclosure, or loss by employing reasonable
				security measures in alignment with the agency information system security
				plan, including physically securing any computers, documents, or other media
				containing confidential information and viewing confidential information only
				on secure workstations in nonpublic areas;
(d) Destroying all confidential information
				according to document retention requirements;
(e) Adhering to the confidentiality
				requirements in this section after the data recipient is no longer an
				authorized data recipient under chapter 70.405 RCW; and
(f) Acknowledging that the data recipient may
				be responsible for liability arising from misuse of the data.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0055 - Prescription drug affordability board-Authorization to assess fines

Current through Register Vol. 24-14, July 15, 2024
(1)
									RCW
				70.405.040 allows the authority to assess a
				fine(s) against a manufacturer for failure to comply with the requirements of
				this chapter. See WAC
				182-52-0065 for fine(s) for
				failing to comply with information request(s) and WAC
				182-52-0070 for the amount of the
				fine(s) based on culpability.
(2)
				The authority may grant an extension of time to an information request deadline
				under WAC
				182-52-0060.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0060 - Prescription drug affordability board-Extension of deadlines

Current through Register Vol. 24-14, July 15, 2024
(1) The authority
				may grant:
(a) An extension of time for an
				information request submission deadline; or
(b) Permission to correct a previously
				submitted and accepted request.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0065 - Prescription drug affordability board-Fine(s) for failure to comply with information request(s)

Current through Register Vol. 24-14, July 15, 2024
(1) The authority
				may assess a fine of up to $100,000 against a manufacturer for each failure to
				comply with a request for information from the board or the authority as
				directed by the board.
(2) The
				assessment of a fine under this section is subject to review under the
				Administrative Procedure Act, chapter 34.05 RCW.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0070 - Prescription drug affordability board-Amount of fine(s) based on culpability

Current through Register Vol. 24-14, July 15, 2024
(1) In determining
				the amount of any fine, the authority considers the level of culpability
				associated with the violation. The levels of culpability, in the order of least
				severe to most severe, are as follows:
(a)
Did not know.
The manufacturer did not know (and, by exercising
				reasonable diligence, could not have known) the violation had
				occurred.
(b)
Reasonable
				cause.
The manufacturer knew, or by exercising reasonable diligence
				should have known, that the violation had taken place, but the manufacturer did
				not act with willful neglect.
(c)
Willful neglect - Corrected.
The violation was due to the
				manufacturer's intentional failure or reckless indifference, and the violation
				was corrected within 30 calendar days from the date the manufacturer knew or
				with reasonable diligence should have known of the violation.
(d)
Willful neglect -
				Uncorrected.
The violation was due to the manufacturer's intentional
				failure or reckless indifference, and the violation was not corrected within 30
				calendar days from the date the manufacturer knew or with reasonable diligence
				should have known of the violation.