reglab/statecodes huggingface dataset:
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0075 - Prescription drug affordability board-Advisory notice, notice of violation, and fine(s)

Current through Register Vol. 24-14, July 15, 2024
(1) The authority
				will issue an advisory notice to the manufacturer for the initial request for
				information directing the manufacturer to comply within 30 calendar days of the
				request or request an extension of time to provide the required information, in
				accordance with WAC
				182-52-0060.
(2) If the manufacturer fails to comply with
				the initial request for information within 30 calendar days, the authority may
				assess a fine(s). The authority will mail a preliminary notice of violation to
				the manufacturer's last known address in a manner that provides proof of
				receipt by the manufacturer.
(3)
				The preliminary notice of violation and fine(s) will include 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(s);
(c) The
				amount of the fine(s); and
(d) An
				explanation of the manufacturer's right to request an informal dispute
				resolution conference.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0080 - Prescription drug affordability board-Appeal determination of a violation and assessed fine(s)

Current through Register Vol. 24-14, July 15, 2024
(1) Each
				manufacturer to whom the authority issues a preliminary notice of violation and
				fine(s) may request an informal dispute resolution conference. If the
				manufacturer does request an informal dispute resolution conference, then the
				manufacturer must complete the process before requesting an administrative
				hearing.
(2) In lieu of an informal
				dispute resolution conference, the manufacturer may request an administrative
				hearing, under WAC
				182-52-0090, in writing, in a
				manner that provides proof of receipt by the authority, within 28 calendar days
				after receipt of the notice of violation and fine(s). Upon receipt of the
				manufacturer's request for administrative hearing, the authority will issue a
				final notice of violation and fine(s) with an explanation of the manufacturer's
				administrative hearing rights (See WAC
				182-52-0090).
(3) If the manufacturer does not request an
				informal dispute resolution conference or administrative hearing 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
				manufacturer's administrative hearing rights (See WAC
				182-52-0090).
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0085 - Prescription drug affordability board-Informal dispute resolution process prior to an administrative hearing

Current through Register Vol. 24-14, July 15, 2024
(1) The
				manufacturer may informally dispute the authority's determination of a
				violation under this chapter.
(2)
				The manufacturer must submit a request for an informal dispute resolution
				conference to the authority in writing, in a manner that provides proof of
				receipt by the authority, within 28 calendar days after receipt of the notice
				violation and fine(s).
(3) Requests
				must specify:
(a) The name of the manufacturer
				requesting the informal dispute resolution conference and the manufacturer's,
				or representative's, mailing address, telephone number, and email address (if
				available);
(b) The items, facts,
				or conclusions in the notice of violation being contested; and
(c) The basis for contesting the authority's
				action, including any mitigating factors upon which the manufacturer relies and
				the outcome the manufacturer is seeking.
Washington Administrative Code › Title 182 - Health Care Authority › PRESCRIPTION DRUG PROGRAMS › Chapter 182-52 - Prescription drug affordability board › Section 182-52-0090 - Prescription drug affordability board-Administrative hearing rights

Current through Register Vol. 24-14, July 15, 2024
A manufacturer has a right to an administrative hearing under
				  chapters 34.05 RCW and 182-526 WAC, if the authority assesses a notice of
				  violation and fine(s) against the manufacturer.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-005 - Authority and purpose

Current through Register Vol. 24-14, July 15, 2024
Under
				  RCW
				  70.14.080 through
				  70.14.140, the director of the
				  Washington state health care authority provides administrative support for, and
				  adopts rules to govern the health technology clinical committee and a health
				  technology assessment program within the health care authority. The health
				  technology assessment program will:
(1) Contract with an evidence-based
				technology assessment center to produce health technology
				assessments;
(2) Administratively
				support the independent health technology clinical committee; and
(3) Maintain a centralized, internet-based
				communication tool.
Statutory Authority:
					 RCW
					 41.05.013,
					 41.05.160, and
					 70.14.090. 06-23-083 (Order
					 06-10), §
											182-55-005, filed 11/13/06,
					 effective 12/14/06.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-010 - Definitions

Current through Register Vol. 24-14, July 15, 2024
When used in this chapter:
(1) "Advisory group" as defined in
				RCW
				70.14.080 means a group established under
				RCW
				70.14.110(2)(c).
(2) "Centralized, internet-based
				communication tool" means the health care authority's health technology
				assessment program internet web pages established under
				RCW
				70.14.130(1).
(3) "Committee" as defined in
				RCW
				70.14.080 means the health technology
				clinical committee established under
				RCW
				70.14.090.
(4) "Coverage determination" as defined in
				RCW 70.14.-080 means a determination of the circumstances, if any, under which
				a health technology will be included as a covered benefit in a state purchased
				health care program.
(5) "Decisions
				made under the federal medicare program" means national coverage determinations
				issued by the Centers for Medicare and Medicaid Services stating whether and to
				what extent medicare covers specific services, procedures, or
				technologies.
(6) "Director" means
				the director of the Washington state health care authority under
				chapter
				41.05 RCW.
(7) "Health technology" as defined in
				RCW
				70.14.080 means medical and surgical devices
				and procedures, medical equipment, and diagnostic tests. Health technologies do
				not include prescription drugs governed by
				RCW
				70.14.050.
(8) "Health technology assessment" means a
				report produced by a contracted, evidence-based, technology assessment center
				or other appropriate entity, as provided for in
				RCW
				70.14.100(4), based on a
				systematic review of evidence of a technology's safety, efficacy, and
				cost-effectiveness.
(9)
				"Participating agency" as defined in
				RCW
				70.14.080 means the department of social and
				health services, the state health care authority, and the department of labor
				and industries.
Statutory Authority:
					 RCW
					 41.05.013,
					 41.05.160, and
					 70.14.090. 06-23-083 (Order
					 06-10), §
											182-55-010, filed 11/13/06,
					 effective 12/14/06.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-015 - Committee purpose

Current through Register Vol. 24-14, July 15, 2024
The purpose of the committee is to make coverage
				  determinations for the participating agencies as described under
				  RCW
				  70.14.110.
Statutory Authority:
					 RCW
					 41.05.013,
					 41.05.160, and
					 70.14.090. 06-23-083 (Order
					 06-10), §
											182-55-015, filed 11/13/06,
					 effective 12/14/06.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-020 - Committee selection

Current through Register Vol. 24-14, July 15, 2024
(1) The director,
				in consultation with the participating state agencies, appoints vacant
				committee positions from a pool of interested applicants. Interested persons
				are provided an opportunity to submit applications to the director for
				consideration.
(2) When appointing
				committee members, the director considers, in addition to the membership
				requirements imposed by
				RCW
				70.14.090, other relevant information,
				including:
(a) Practitioner specialty or type
				and use of health technologies, especially in relation to current committee
				member specialty or types;
(b)
				Practice location and community knowledge;
(c) Length of practice experience;
(d) Knowledge of and experience with
				evidence-based medicine, including formal additional training in fields
				relevant to evidence-based medicine;
(e) Medical quality assurance experience;
				and
(f) Health technology
				assessment review experience.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-025 - Committee member requirements and committee member terms

Current through Register Vol. 24-14, July 15, 2024
(1) As a continuing
				condition of appointment, committee members must:
(a) Not have a substantial financial conflict
				of interest, such as an interest in a health technology company, including the
				holding of stock options, or the receipt of honoraria, or consultant
				moneys;
(b) Complete a conflict of
				interest disclosure form, update the form annually, and keep disclosure
				statements current;
(c) Abide by
				confidentiality requirements and keep all personal medical information and
				proprietary information confidential; and
(d) Not use information gained from committee
				membership outside of committee responsibilities, unless the information is
				publicly available.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-026 - Committee governance

Current through Register Vol. 24-14, July 15, 2024
(1) The
				committee may establish bylaws, within applicable statutory and regulatory
				requirements, to govern the orderly resolution of the committee's purposes.
				Proposed bylaw amendments are published on the centralized, internet-based
				communication tool at least fourteen calendar days before adoption by the
				committee. Before adoption, the committee gives an opportunity at an open
				public meeting for public comment on proposed bylaw amendments. Committee
				bylaws shall be published on the centralized, internet-based communication
				tool.
(2) The director appoints a
				committee chair.
(3) The committee
				chair:
(a) Selects a vice-chair from among
				the committee membership;
(b)
				Presents bylaws, or amendments to the bylaws, to the committee for review and
				ratification; and
(c) Operates the
				committee according to the bylaws and committee member agreements.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-030 - Committee coverage determination process

Current through Register Vol. 24-14, July 15, 2024
(1) In making a coverage determination,
				committee members shall review and consider evidence regarding the safety,
				efficacy, and cost-effectiveness of the technology as set forth in the health
				technology assessment. The committee also considers other information it deems
				relevant, including other information provided by the director, reports or
				testimony from an advisory group, and submissions or comments from the
				public.
(2) The committee shall
				give the greatest weight to the evidence determined, based on objective
				factors, to be the most valid and reliable, considering the nature and source
				of the evidence, the empirical characteristic of the studies or trials upon
				which the evidence is based, and the consistency of the outcome with comparable
				studies. The committee also considers additional evidentiary valuation factors
				such as recency , relevance, and bias.
(3) The committee also considers any unique
				impacts the health technology has on specific populations based on factors like
				sex, age, ethnicity, race, or disability, as identified in the health
				technology assessment.
(4) The
				committee provides an opportunity for public comment after the health
				technology assessment is published on the centralized, internet-based
				communication tool and before the committee's final coverage determination
				decision.
(5) After the committee
				makes a final coverage determination, the health technology assessment program
				publishes it on the centralized, internet-based communication tool and submits
				a notice in the
Washington State Register
.
Statutory Authority:
					 RCW
					 41.05.013,
					 41.05.160, and
					 70.14.090. 06-23-083 (Order
					 06-10), §
											182-55-030, filed 11/13/06,
					 effective 12/14/06.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-035 - Committee coverage determination

Current through Register Vol. 24-14, July 15, 2024
The committee shall:
(1) Determine the conditions, if any, under
				which the health technology will be included as a covered benefit in health
				care programs of participating agencies by deciding that:
(a) Coverage is allowed without special
				conditions because the evidence is sufficient to conclude that the health
				technology is safe, efficacious, and cost-effective for all indicated
				conditions; or
(b) Coverage is
				allowed with special conditions because the evidence is sufficient to conclude
				that the health technology is safe, efficacious, and cost-effective in only
				certain situations; or
(c) Coverage
				is not allowed because either the evidence is insufficient to conclude that the
				health technology is safe, efficacious, and cost-effective or the evidence is
				sufficient to conclude that the health technology is unsafe, inefficacious, or
				not cost-effective.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-040 - Health care authority's implementation of final coverage determinations

Current through Register Vol. 24-14, July 15, 2024
This section applies to all final coverage determinations
				  made after August 1, 2016.
(1) The
				health care authority reviews the final coverage determination for conflicts
				identified in
				RCW
				70.14.120(1)(a) and
				(b).
(2) The health care authority reviews whether
				the health technology review process meets the requirements in this subsection
				before compliance by the health care authority's state-purchased health care
				programs. The review includes whether the:
(a)
				Notification of the health technology selected for review was made on the
				centralized, internet-based communication tool as required by
				RCW
				70.14.130(1)(a);
(b) Health technology assessment provided to
				the committee met the requirements in
				RCW
				70.14.100(4)  and WAC
				182-55-055;
(c)Health technology assessment was published
				on the centralized, internet-based communication tool at least fourteen
				calendar days before the committee's consideration of the health technology
				assessment;
(d) Health technology
				assessment was considered by the committee in an open and transparent process,
				as required by
				RCW
				70.14.110(2)(a);
(e) Committee provided an opportunity for
				public comment prior to the committee's final coverage determination
				decision;
(f) Committee
				acknowledged public comment timely received after publication of the
				committee's draft coverage determination and before the committee's final
				coverage determination decision;
(g) Committee's final coverage determination
				specifies the reason or reasons for a decision that is inconsistent with the
				identified decisions made under the federal medicare program and expert
				treatment guidelines, including those from specialty physician and patient
				advocacy organizations, for the reviewed health technology; and
(h) Committee meetings complied with the
				requirements of the Open Public Meetings Act as required by RCW
				70.14.-090(3).
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-041 - Judicial review of final coverage determination

Current through Register Vol. 24-14, July 15, 2024
Nothing in this chapter limits the superior court's inherent
				  authority to review health technology clinical committee determinations to the
				  extent of assuring the decisions are not arbitrary, capricious, or contrary to
				  law.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-045 - Advisory group

Current through Register Vol. 24-14, July 15, 2024
(1) The committee
				chair, upon an affirmative vote of the committee members, may establish ad hoc
				temporary advisory groups under
				RCW
				70.14.110(2)(c). At the time
				an ad hoc temporary advisory group is formed, the committee must state the ad
				hoc temporary advisory group's objective and questions to address. Notice of
				the formation of an ad hoc temporary advisory group, and information about how
				to participate, shall be posted on the centralized, internet-based
				communication tool.
(2) The
				committee chair, or designee, may appoint or remove an advisory group member.
				An ad hoc temporary advisory group must include at least three members. The
				advisory group will generally include at least one enrollee, client, or
				patient. The advisory group must have:
(a)
				Two or more experts or specialists within the field relevant to the health
				technology, preferably with demonstrated experience in the use, evaluation, or
				research of the health technology;
(b) At least one expert who is a proponent or
				advocate of the health technology; and
(c) At least one expert who is an opponent or
				critic of the health technology.
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-050 - Health technology selection

Current through Register Vol. 24-14, July 15, 2024
(1)
				The director, in consultation with participating agencies and the committee,
				selects health technologies to be reviewed or rereviewed by the
				committee.
(2) The director or
				committee may also consider petitions requesting initial review of a health
				technology from interested parties.
To suggest a topic for initial review, interested parties
				  must use the petition form made available on the centralized, internet-based
				  communication tool. The health technology assessment program will provide
				  copies of the petition to the director, committee members, and participating
				  agencies.
(a) Petitions are considered
				by the director, in consultation with participating agencies and the
				committee.
(b) Only after the
				director has declined to grant the petition can a petition be considered for
				selection by the committee, as described in
				RCW
				70.14.100(3).
(c) If a health technology is selected by the
				committee , the health technology is referred to the director for assignment to
				the next available contract for a health technology assessment review as
				described in
				RCW
				70.14.100(4).
Washington Administrative Code › Title 182 - Health Care Authority › HEALTH TECHNOLOGY ASSESSMENT PROGRAM › Chapter 182-55 - Health technology assessment program › Section 182-55-055 - Health technology assessment

Current through Register Vol. 24-14, July 15, 2024
(1)
				Upon providing notice on the centralized, internet-based communication tool
				required by
				RCW
				70.14.100(1)(b) that the
				health technology has been selected for review, the director shall post an
				invitation for interested parties to submit information relevant to the health
				technology for consideration by the evidence-based technology assessment
				center. The information must be submitted to the director or designee within
				thirty calendar days from the date of the notice.
(2) Upon notice of the health technology
				selected for review, the director or designee shall request participating
				agencies to provide information relevant to the health technology, including
				data on safety, health outcome, and cost. The relevant information must be
				submitted to the director or designee within thirty calendar days from the date
				of the notice.
(3) Upon notice of
				the health technology selected for review, the director or designee shall
				identify relevant decisions made under the federal medicare program and expert
				treatment guidelines, including those from specialty physician and patient
				advocacy organizations, and any referenced information used as the basis for
				such determinations or guidelines.
(4) The director shall provide all
				information gathered under subsections (1), (2), and (3) of this section to the
				evidence-based technology assessment center and shall post such information,
				along with the key questions for review, on the centralized, internet-based
				communication tool.
(5) Upon
				completion of the health technology assessment by the evidence-based technology
				assessment center, the director shall publish a copy of the health technology
				assessment on the centralized, internet-based communication tool and provide
				the committee with:
(a) A copy of the health
				technology assessment;
(b) A copy
				of decisions made under the federal medicare program related to the health
				technology being reviewed and accompanying information describing the basis for
				the decision;
(c) Information as to
				whether expert treatment guidelines exist, including those from specialty
				physician organizations and patient advocacy organizations, and describing the
				basis for the guidelines.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-005 - Authority and purpose

Current through Register Vol. 24-14, July 15, 2024
Under
				  RCW
				  7.70.060(4), the agency's
				  medical director is authorized to independently assess and certify patient
				  decision aids.
Statutory Authority:
					 RCW
					 7.70.060 and
					 2012 c
					 101 . 12-24-052, §
											182-60-005, filed 11/30/12,
					 effective 1/1/13.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-010 - Definitions

Current through Register Vol. 24-14, July 15, 2024
When used in this chapter:
(1)
"Agency"
means the
				Washington state health care authority (HCA), created pursuant to chapter 41.05
				RCW.
(2)
"Certification
				fee"
means a fee assessed by the agency to an individual or organization
				applicant requesting certification or recertification of a patient decision aid
				not already certified by an organization located in the United States or Canada
				and recognized by the agency's medical director.
(3)
"Certified patient decision
				aid"
means a patient decision aid, as defined in this section, for any
				medical condition or procedure, including abortion as defined in
				RCW
				9.02.170, that:
(a) Is certified by one or more national
				certifying organizations recognized by the agency's medical director;
				or
(b) Has been evaluated based on
				the International Patient Decision Aid Standards (IPDAS) by an organization
				located in the United States or Canada and has current scores satisfactory to
				the agency's medical director in each of the following categories: Content
				criteria, development process criteria, and effectiveness criteria;
				or
(c) Is independently assessed
				and certified by the agency's medical director based on the International
				Patient Decision Aid Standards developed by the IPDAS Collaboration if a
				current evaluation is not available from an organization located in the United
				States or Canada.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-020 - National certifying organizations

Current through Register Vol. 24-14, July 15, 2024
The agency's medical director :
(1) Maintains a list of recognized national
				certifying organizations so that individuals or organizations seeking
				certification may identify organizations recognized by the agency's medical
				director.
(2) Considers
				organizations recommended by applicants for inclusion in the list.
(3) Updates the list as needed.
Statutory Authority:
					 RCW
					 7.70.060 and
					 2012 c
					 101 . 12-24-052, §
											182-60-020, filed 11/30/12,
					 effective 1/1/13.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-025 - Agency review process and certification

Current through Register Vol. 24-14, July 15, 2024
(1) When independently reviewing decision
				aids under RCW
				7.70.060(4)(a)(ii), the
				agency's medical director uses agency certification criteria, which are based
				on criteria developed by the International Patient Decision Aid Standards
				(IPDAS) Collaboration, for evaluation of a patient decision aid.
(2) The agency's medical director may certify
				a patient decision aid if it is reviewed by a national certifying organization
				and has current scores satisfactory to the agency's medical director in each of
				the following categories: Content criteria, development process criteria, and
				effectiveness criteria.
(3) An
				applicant requesting review and certification must provide written
				documentation of the basis for certification as provided in subsection (1) of
				this section, using the application materials developed by the
				agency.
(4) The agency's medical
				director may contract for an assessment of the patient decision aid.
(a) The contract will:
(i) Be with an evidence-based organization or
				other appropriate entity; and
(ii)
				Require an assessment to evaluate the patient decision aid based on the
				agency's IPDAS-based certification criteria using information provided by the
				applicant and the agency's medical director.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-027 - Patient decision aid review advisory panel

Current through Register Vol. 24-14, July 15, 2024
(1) The agency's medical director has the
				authority to establish one or more expert advisory panels to review patient
				decision aids using established criteria under WAC
				182-60-025.
(2) The panel may include the following as
				necessary:
(a) Practicing physicians or other
				relevant licensed health professionals;
(b) Health literacy and numeracy
				experts;
(c) Experts in shared
				decision making;
(d) Legal experts;
				and
(e) Patient
				representatives.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-030 - Certification fees

Current through Register Vol. 24-14, July 15, 2024
The agency charges one or more fees to an applicant to
				  defray the costs of assessments, certifications, recertifications, and any
				  opportunities to remedy deficiencies in the application, according to this
				  chapter.
(1) Fees are based on the
				reasonable projected or actual cost of the certification program.
(2) Except as otherwise provided in this
				chapter, a certification fee applies to each review of a patient decision aid.
				An opportunity to remedy deficiencies as described in WAC 182-60-045 may
				require an additional fee.
(3) The
				agency may, at its discretion, waive or otherwise reduce applicable fees for
				patient decision aids publicly available at no cost.
Statutory Authority:
					 RCW
					 7.70.060 and
					 2012 c
					 101 . 12-24-052, §
											182-60-030, filed 11/30/12,
					 effective 1/1/13.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-035 - Patient decision aid topic selection

Current through Register Vol. 24-14, July 15, 2024
(1) The agency may, at the medical director's
				discretion, give preference to certification of patient decision aids
				identified as priority topics for shared decision making by the Healthier
				Washington Initiative, the Robert Bree collaborative, or other topics that are
				important to state health care purchasing or policy objectives.
(2) Periodically throughout the year, the
				agency may issue a request for submission of specific patient decision aid
				topics that address state priorities.
(3) The agency may review additional decision
				aids that do not reflect the topics requested in its solicitation but may
				decline or defer review based on resource limitations or priorities for
				review.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-040 - Agency medical director certification

Current through Register Vol. 24-14, July 15, 2024
(1) Decisions.
(a) The agency's medical director, with input
				as determined necessary by an advisory review team, or contracted experts, or
				both, makes a written determination to:
(i)
				Certify the decision aid;
(ii)
				Notify the developer of areas of deficiency and provide an opportunity to
				remedy deficiencies as described in WAC
				182-60-045;
				or
(iii) Decline to certify the
				decision aid.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-045 - Opportunity to remedy deficiencies

Current through Register Vol. 24-14, July 15, 2024
(1)
				The agency's medical director may suspend the certification or recertification
				process if the medical director determines there are deficiencies in an
				application, including the decision aid and supporting materials.
(2) The agency provides the developer with a
				written notice of deficiencies and gives an opportunity to provide additional
				information or materials. The developer must pay any additional fees related to
				the review of additional information.
(3) The developer must submit any additional
				materials within sixty calendar days of the date on the written
				notice.
(4) The medical director
				makes a final decision to certify or to decline to certify the decision aid
				within sixty calendar days of receipt of the developer's materials.
Washington Administrative Code › Title 182 - Health Care Authority › PATIENT DECISION AIDS › Chapter 182-60 - Patient decision aids › Section 182-60-050 - Public notices

Current through Register Vol. 24-14, July 15, 2024
The agency posts the following information on its web
				  site:
(1) Priority certification
				topics and the timeline for application and consideration of submitted decision
				aids;
(2) Certification forms and
				criteria;
(3) A complete listing of
				certified decision aids and certification effective dates; and
(4) All notifications of certification
				expirations, withdrawals, and suspensions.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-010 - Purpose

Current through Register Vol. 24-14, July 15, 2024
(1) Chapter 43.371
				  RCW establishes the framework for the creation and administration of a
				  statewide all-payer health care claims database.
(2)
										RCW
				  43.371.020 directs the health care authority
				  to establish a statewide all-payer health care claims database to support
				  transparent public reporting of health care information. The authority shall
				  select a lead organization to coordinate and manage the database. The lead
				  organization shall also contract with a data vendor to perform data collection,
				  processing, aggregation, extracts, and analytics.
(3)
										RCW 43.371.070
				  mandates that the director of the health care authority adopt rules necessary
				  to implement chapter 43.371 RCW. In addition,
				  RCW
				  43.371.010 and
				  43.371.050
				  direct the adoption of specific rules by the director.
(4)The purpose of this chapter is to
				  implement chapter 43.371 RCW, to facilitate the creation and administration of
				  the Washington statewide all-payer health care claims database.
Statutory Authority: Chapter 43.371 RCW. WSR 16-04-068,
						§
												82-75-010,
						filed 1/29/16, effective 2/29/16.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-040 - Registration requirements

Current through Register Vol. 24-14, July 15, 2024
(1)
Washington covered persons threshold for data suppliers.
Any
				  carrier, third-party administrator, public program, or other potential data
				  supplier identified in
				  RCW
				  43.371.030 with 1000 or more Washington
				  covered persons, as defined in WAC
				  182-70-030,
				  as of December 31st of the previous calendar year must submit data in
				  accordance with this chapter.
(a) For the
				  purposes of determining whether a potential data supplier is subject to the
				  requirements of this chapter, potential data suppliers must aggregate the
				  number of Washington covered persons for all companies at the group code level,
				  as defined by the National Association of Insurance Commissioners.
(b) Potential data suppliers that offer any
				  combination of medical, dental, or pharmaceutical benefits under separate or
				  combined plans must count all Washington covered persons, regardless of the
				  comprehensiveness of the plan, toward the 1000 Washington covered persons
				  threshold.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-050 - Data submission schedule

Current through Register Vol. 24-14, July 15, 2024
(1)
				  Data suppliers shall submit the required health care data in accordance with
				  the schedule provided in this section.
(2)
Test file.
(a) At least sixty calendar days prior to the
				  data suppliers' first required submission, the lead organization will notify
				  the data supplier in writing regarding the obligation to file. The lead
				  organization will schedule time to work with the data supplier to establish a
				  schedule for when the data supplier shall submit the initial test
				  files.
(b) No more than ninety
				  calendar days after notification of changes in requirements in the data
				  submission guide, the data supplier shall submit initial test files. This
				  deadline may be extended by the lead organization when it determines that
				  additional time will be needed in order for the change to be
				  implemented.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-060 - Historical data submission

Current through Register Vol. 24-14, July 15, 2024
(1) The
				  purpose of collecting historical data into the WA-APCD is to permit the
				  systematic analysis of the health care delivery system including evaluation of
				  the effectiveness of the Patient Protection and Affordable Care Act signed into
				  law on March 23, 2010.
(2)The lead
				  organization will provide written notification to the data suppliers when the
				  WA-APCD is ready to accept the submission of historical data. Data suppliers
				  shall submit the historical data within sixty days of notification. Requests
				  for an extension of time to submit historical data shall be made in accordance
				  with WAC 182-70-080(3).
(3)
				  "Historical data" means covered medical services claim files, pharmacy claim
				  files, dental claim files, member eligibility and enrollment data files, and
				  provider data files with necessary identifiers for the period January 1, 2013,
				  through December 31, 2016, or through the end of the quarter immediately prior
				  to the first regular quarterly submission due in accordance with the data
				  submission schedule.
(4) The
				  authority may grant an exception to this section and approve the filing of
				  historical data for a period less than the period specified in subsection (3)
				  of this section. Requests for an exception under this subsection shall be made
				  to the lead organization within fifteen calendar days of being notified in
				  accordance with subsection (2) of this section. The lead organization shall
				  make a recommendation to the authority as to whether to approve or deny the
				  request. The authority may approve the request for good cause.
Statutory Authority: Chapter 43.371 RCW. WSR 17-05-024,
						§
												82-75-060,
						filed 2/7/17, effective 3/10/17; WSR 16-04-068, §
												82-75-060,
						filed 1/29/16, effective 2/29/16.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-070 - Data submission guide

Current through Register Vol. 24-14, July 15, 2024
(1) Data
				  files and claim files shall be submitted to the WA-APCD in accordance with the
				  requirements set forth in this chapter and the data submission guide.
(2)The lead organization shall develop the
				  data submission guide with input from stakeholders. The lead organization shall
				  develop a process to allow for stakeholder review and comment on drafts of the
				  data submission guide and all subsequent changes to the guide. The authority
				  shall have final approval authority over the data submission guide and all
				  subsequent changes.
(3) The lead
				  organization shall notify data suppliers before changes to the data submission
				  guide are final. Notification shall occur no less than one hundred twenty
				  calendar days prior to the effective date of any change.
(4) Upon good cause shown, data suppliers may
				  be granted an extension to comply with any changes to the data submission
				  guide. Requests for extensions or exceptions shall be made in accordance with
				  WAC 182-70-080.
Statutory Authority: Chapter 43.371 RCW. WSR 16-04-068,
						§
												82-75-070,
						filed 1/29/16, effective 2/29/16.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-080 - Waivers and extensions

Current through Register Vol. 24-14, July 15, 2024
(1) The
				  authority may grant a waiver of reporting requirements or an extension of time
				  to a reporting requirement deadline based on extenuating
				  circumstances.
(2)
Waivers.
(a) A data supplier may
				  request a waiver from submission for a period of time due to extenuating
				  circumstances affecting the data supplier's ability to comply with the
				  reporting requirement for that period.
(b) The request shall be for no more than one
				  reporting year and shall contain a detailed explanation as to the reason the
				  data supplier is unable to meet the reporting requirements.
(c) A request for a waiver must be submitted
				  to the lead organization at least sixty calendar days prior to the applicable
				  reporting deadline. The lead organization shall make a recommendation to the
				  authority as to whether to approve or deny the request. The approval
				  recommendation shall also state whether the approval is for the entire period
				  requested or for a period less than requested.
(d) The authority may approve a request for
				  extenuating circumstances. Approval may be for a time period shorter than
				  requested. The authority shall approve or deny the request and provide written
				  notification to the requester within thirty calendar days of receipt of the
				  request. The authority decision on the request for a waiver will be provided in
				  writing. If the authority does not approve a request for a waiver, the written
				  notification will include the reason for the denial.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-090 - Penalties 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 requirements of this chapter including, but not
				  limited to:
(a) General reporting
				  requirements.
(b) Health care claim
				  files and data files requirements.
(c) Health care claim files and data files
				  submission requirements.
The authority will not assess fines when the data supplier
					 is working in good faith with the lead organization to comply with the
					 reporting requirements.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-100 - Administrative review

Current through Register Vol. 24-14, July 15, 2024
(1) Data suppliers
				  may request an administrative review of an authority decision to deny a request
				  for an extension or waiver, or an assessment of a fine.
(2) A request for an administrative review
				  may be initiated by a written petition filed with the authority within thirty
				  calendar days after notice of the denial or assessment of a fine. The petition
				  shall include the following information:
(a)
				  Data supplier's name, address, telephone number, email address and contact
				  person.
(b) Information about the
				  subject of the appeal including remedy requested.
(c) A detailed explanation as to the issue or
				  area of dispute, and why the dispute should be decided in the data supplier's
				  favor.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › ALL PAYER HEALTH CARE CLAIMS DATABASE › Section 182-70-110 - Appeals

Current through Register Vol. 24-14, July 15, 2024
A data supplier may request an appeal of a denial of its
					 administrative review conducted in accordance with WAC
					 182-70-100.
					 See WAC 182-526-0205.
Statutory Authority: Chapter 43.371 RCW. WSR 16-04-068,
						§
												82-75-110,
						filed 1/29/16, effective 2/29/16.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › DATA REQUESTS AND RELEASE PROCEDURES › Section 182-70-200 - General data request and release procedures

Current through Register Vol. 24-14, July 15, 2024
(1) The lead organization must adopt clear
				  policies and procedures for data requests and data release. At a minimum, the
				  lead organization, in coordination with the data vendor, must develop
				  procedures for making a request for data, how data requests will be reviewed,
				  how decisions will be made on whether to grant or disapprove release of the
				  requested data, and data release processes. The policies and procedures must be
				  approved by the authority.
(2) The
				  lead organization should help data requestors identify the best ways to
				  describe and tailor the data request, understand the privacy and security
				  requirements, and understand the limitations on use and data products derived
				  from the data released.
(3) The
				  lead organization must maintain a log of all requests and action taken on each
				  request. The log must include at a minimum the following information: Name of
				  requestor, data requested, purpose of the request, whether the request was
				  approved or denied, if approved the date and data released, and if denied the
				  date and reason for the denial. The lead organization shall post the log on the
				  WA-APCD website that the lead organization is required to maintain.
Statutory Authority: Chapter 43.371 RCW. WSR 16-22-062,
						§
												82-75-200,
						filed 11/1/16, effective 12/2/16.
Washington Administrative Code › Title 182 - Health Care Authority › ALL PAYER HEALTH CARE CLAIMS DATABASE › Chapter 182-70 - All payer health care claims database › DATA REQUESTS AND RELEASE PROCEDURES › Section 182-70-210 - Procedures for data requests

Current through Register Vol. 24-14, July 15, 2024
(1)
				  The lead organization must use an application process for data
				  requests.
(2) In addition to the
				  requirements in
				  RCW
				  43.371.050(1), at a minimum,
				  the application must require the following information:
(a) Detailed information about the project
				  for which the data is being requested including, but not limited to:
(i) Purpose of the project and data being
				  requested, and level of detail for the data requested.
(ii) Methodology for data analysis and
				  timeline for the project.
(iii) If
				  applicable, copy of an Institutional Review Board (IRB) protocol and approval
				  or Exempt Determination and application for the IRB exemption for the project
				  review. Researchers must use an IRB that has been registered with the United
				  States Department of Health and Human Services Office of Human Research
				  Protections. The IRB may however be located outside the state of
				  Washington.
(iv) Staffing
				  qualifications and resumes.
(v)
				  Information on third-party organizations or individuals who may have access to
				  the requested data as part of the project for which the data is requested. The
				  information provided must include the same information required by the
				  requestor, as applicable. Data cannot be shared with third parties except as
				  approved in a data request.