justicedao/ipfs_state_laws huggingface dataset:
409-055-0040 Recognition Criteria (1) The PCPCH recognition criteria are divided into “Must-Pass” measures and other measures that place the practice on a scale of maturity or ‘tier’ that reflect basic to more advanced PCPCH functions. (2) Must-Pass and 5-point measures focus on foundational PCPCH elements. (3) 10- and 15-point measures reflect intermediate and advanced functions. (4) Except for the 13 Must-Pass measures, each measure is assigned a point value. A practice must meet the following point allocation criteria to be recognized as a PCPCH: (a) Tier 3: 100-245 points and all 13 Must-Pass Measures; (b) Tier 4: 250-390 points and all 13 Must-Pass Measures; (c) Tier 5: 395-530 points and all 13 Must-Pass Measures. (5) The Authority may award a Patient-Centered Primary Care Home the Health Equity Designation for implementing health equity measures as described OAR 409-055-0045. (6) The Authority shall calculate a practice’s point score through the recognition process described in OAR 409-055-0030. (7) Table 1, incorporated by reference, contains the detailed list of Measures and corresponding point assignments. (8) National Committee for Quality Assurance (NCQA) recognition shall be acknowledged in the Authority’s PCPCH recognition process; however, a practice is not required to use its NCQA recognition to meet the Oregon PCPCH standards. A practice that does not wish to use its NCQA recognition to meet the Oregon PCPCH standards must indicate so during the PCPCH application process and submit a complete PCPCH application. (9) A practice seeking Oregon PCPCH Tier 5 recognition based on its NCQA recognition must submit an abbreviated PCPCH application attesting to selected Oregon PCPCH standards and evidence of its NCQA recognition along with its application. (10) A practice seeking Oregon PCPCH Health Equity Designation based on its NCQA recognition must submit a complete PCPCH application and comply with OAR 409-055-0045. [ED. NOTE: To view attachments referenced in rule text, click here to view rule.] Statutory/Other Authority: ORS 413.042, ORS 413.259 & 414.655 Statutes/Other Implemented: ORS 413.259, 413.260 & 414.655 History: OHP 3-2023, amend filed 11/30/2023, effective 11/30/2023 OHP 3-2020, amend filed 08/10/2020, effective 08/10/2020 OHP 16-2016, f. & cert. ef. 12-22-16 OHP 9-2016, f. & cert. ef. 5-13-16 OHP 10-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-24-16 OHP 2-2015, f. 1-16-15, cert. ef. 2-1-15 OHP 9-2013, f. 10-1-13, cert. ef. 1-1-14 OHP 2-2012, f. 2-29-12, cert. ef. 3-1-12 OHP 6-2011(Temp), f. 9-29-11, cert. ef. 10-1-11 thru 3-15-12
409-055-0045 Health Equity Designation (1) The Authority shall award Health Equity designations to practices implementing multiple PCPCH Health Equity measures. (2) A practice seeking the Health Equity Designation, must meet the following criteria: (a) Be recognized as a PCPCH under the Measures in 409-055-0040 Table 1, adopted and incorporated by reference; (b) Attest to 15 or more of the 20 PCPCH Health Equity Measures in Table 2 adopted and incorporated by reference; (c) Submit all required documentation for the Health Equity Measures in Table 2 attested to at the time of application. (3) The Authority shall review PCPCH applications of practices attesting to the Measures in Table 2 and the documentation submitted to determine which practices meet the criteria in section (2) of this rule. (4) The Authority shall notify a practice meeting Health Equity designation criteria in writing of their eligibility. (5) The Authority shall award Health Equity designation to a practice after verifying the practice meets all Health Equity designation criteria. (6) Health Equity designation is valid for the duration of the practice’s current PCPCH recognition as described in OAR 409-055-0030(7). [ED. NOTE: To view attachments referenced in rule text, click here to view rule.] Statutory/Other Authority: ORS 413.042, ORS 413.259 & 414.655 Statutes/Other Implemented: ORS 413.259, 413.260 & 414.655 History: OHP 3-2023, amend filed 11/30/2023, effective 11/30/2023 OHP 3-2020, amend filed 08/10/2020, effective 08/10/2020 OHP 15-2018, amend filed 11/29/2018, effective 12/01/2018 OHP 12-2018, minor correction filed 09/25/2018, effective 09/25/2018 OHP 11-2018, minor correction filed 09/25/2018, effective 09/25/2018 OHP 16-2016, f. & cert. ef. 12-22-16 OHP 9-2016, f. & cert. ef. 5-13-16 OHP 2-2015, f. 1-16-15, cert. ef. 2-1-15
409-055-0050 Data Reporting Requirements for Recognized PCPCHs (1) To be recognized as a PCPCH, a practice must attest to meeting the criteria and submit quantitative data elements to support its attestation in accordance with 409-055-0040 Table 1 incorporated by reference. (2) Quantitative data shall be aggregated at the practice level, not the individual patient level, and a practice may not transfer any personal health information to the Authority during the PCPCH application process. (3) PCPCHs must submit new quantitative and attestation data as a part of the recognition renewal process and must use the specifications found on the Program website for calculating application data. (4) If approved by the practice, other entities may submit information on behalf of a practice, as long as appropriate practice staff has reviewed all application information and data prior to submission. (5) Practices are required to submit 12 months of quantitative data to meet PCPCH standards. A practice may request an exception to the 12-month data reporting period by submitting a form prescribed by the program. The Authority may grant exceptions for good cause shown. (6) The Authority shall notify the practice within 60 days of complete application and exception submission whether the requested exception has been granted. Statutory/Other Authority: ORS 413.042, 413.259 & 414.655 Statutes/Other Implemented: ORS 413.259, 413.260 & 414.655 History: OHP 3-2023, amend filed 11/30/2023, effective 11/30/2023 OHP 16-2016, f. & cert. ef. 12-22-16 OHP 9-2016, f. & cert. ef. 5-13-16 OHP 9-2013, f. 10-1-13, cert. ef. 1-1-14 OHP 2-2012, f. 2-29-12, cert. ef. 3-1-12 OHP 6-2011(Temp), f. 9-29-11, cert. ef. 10-1-11 thru 3-15-12
409-055-0060 Verification (1) The Authority shall conduct at least one on-site verification review of each recognized PCPCH to determine compliance with PCPCH criteria every five years and at such other times as the Authority deems necessary or at the request of the Health Systems Division (Division), or any other applicable program within the Authority. The purpose of the review is to verify reported attestation and quantitative data elements for the purposes of confirming recognition and Tier level. (2) PCPCHs selected for a verification review shall be notified no less than 30 days prior to the scheduled review. (3) PCPCHs shall permit Authority staff access to the practice’s place of business during the review. (4) A verification review may include but is not limited to: (a) Review of documents and records. (b) Review of patient medical records. (c) Review of electronic medical record systems, electronic health record systems, and practice management systems. (d) Review of data reports from electronic systems or other patient registry and tracking systems. (e) Interviews with practice management, clinical and administrative staff. (f) On-site observation of practice staff. (g) On-site observation of patient environment and physical environment. (5) Following a verification review, Authority staff may conduct an exit conference with the PCPCH representatives. During the exit conference Authority staff shall: (a) Inform the PCPCH representative of the preliminary findings of the review; and (b) Give the PCPCH a reasonable opportunity to submit additional facts or other information to the Authority staff in response to those findings. (6) Following the review, Authority staff shall prepare and provide the PCPCH specific and timely written notice of the findings. (7) If the findings result in a referral to the Division pursuant to OAR 409-055-0070, Authority staff shall submit the applicable information to the Division for its review and determination of appropriate action. (8) If no deficiencies are found during a review, the Authority shall issue written findings to the PCPCH indicating that fact. (9) If deficiencies are found, the Authority shall take informal or formal enforcement action pursuant to OAR 409-055-0070. (10) The Authority may share application information and content submitted by practices and verification findings with managed or coordinated care plans, and insurance carriers. Statutory/Other Authority: ORS 413.042, 413.259 & 414.655 Statutes/Other Implemented: ORS 413.259, 413.260 & 414.655 History: OHP 3-2023, amend filed 11/30/2023, effective 11/30/2023 OHP 9-2016, f. & cert. ef. 5-13-16 OHP 10-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-24-16 OHP 9-2013, f. 10-1-13, cert. ef. 1-1-14 OHP 2-2012, f. 2-29-12, cert. ef. 3-1-12 OHP 6-2011(Temp), f. 9-29-11, cert. ef. 10-1-11 thru 3-15-12
409-055-0070 Compliance (1) If the Authority finds that the practice is not in compliance with processes as attested to, the Authority shall issue a written warning requiring the practice to submit an improvement plan within 90 days of the date of the written warning. The improvement plan must include a description of the practice’s plan and timeline to correct the deficiency and proposed documentation or other demonstration that would verify the practice is in compliance. (2) The Authority shall review the improvement plan and any documentation the practice submits in accordance with the deficiency, and if remedied, no further action shall be taken. (3) If a practice fails to submit the improvement plan or move into compliance within 90 days of the date of the written warning, the Authority may issue a letter of non-compliance and amend the practice’s PCPCH recognition to reflect the appropriate Tier level or revoke its PCPCH status. (4) If the Authority amends a practice’s tier level or revokes PCPCH status this information shall be made available to the Health Systems Division (Division), the coordinated care or managed care plans, and insurance carriers. (5) A practice that has had its PCPCH status revoked may have it reissued after reapplying for recognition and when the Authority determines that compliance with PCPCH Standards has been achieved satisfactorily. (6) The Authority may revoke a practice’s PCPCH recognition in the following circumstances: (a) The practice submits false quantitative data elements or falsely attests to meeting PCPCH recognition criteria; (b) The practice misrepresents its PCPCH status or tier level; (c) The practice is not compliant with a verification review as described in OAR 409-055-0060. Statutory/Other Authority: ORS 413.042, ORS 413.259 & 414.655 Statutes/Other Implemented: ORS 413.259, 413.260 & 414.655 History: OHP 3-2020, amend filed 08/10/2020, effective 08/10/2020 OHP 18-2018, minor correction filed 12/03/2018, effective 12/03/2018 OHP 15-2018, amend filed 11/29/2018, effective 12/01/2018 OHP 9-2016, f. & cert. ef. 5-13-16 OHP 10-2015(Temp), f. 12-29-15, cert. ef. 1-1-16 thru 6-24-16 OHP 9-2013, f. 10-1-13, cert. ef. 1-1-14 OHP 2-2012, f. 2-29-12, cert. ef. 3-1-12 OHP 6-2011(Temp), f. 9-29-11, cert. ef. 10-1-11 thru 3-15-12
409-055-0080 Insurance Carrier, Managed Care Plan, and Public Stakeholder Communication (1) The Authority shall develop a system for making recognized PCPCH Tier status recognition information available to insurance carriers and managed care organizations. (2) The Authority shall maintain and update monthly the recognized PCPCH Tier status lists. (3) The Authority shall develop a system for making recognized PCPCH practice names available to the general public through the Program website. (4) Practices that do not wish to have their name listed on the publicly available list must send an e-mail to PCPCH@state.or.us with the title “opt-out” in the subject line within 10 business days of receiving confirmation of Tier status pursuant to OAR 409-055-0040. Statutory/Other Authority: ORS 413.042, 413.259 & 414.655 Statutes/Other Implemented: ORS 413.259, 413.260 & 414.655 History: OHP 9-2016, f. & cert. ef. 5-13-16 OHP 2-2012, f. 2-29-12, cert. ef. 3-1-12 OHP 6-2011(Temp), f. 9-29-11, cert. ef. 10-1-11 thru 3-15-12
409-055-0090 Reimbursement Objectives (1) One objective of these standards is to facilitate appropriate reimbursement for PCPCHs consistent with their recognized Tier levels. The standards and Tier recognition process established in this rule are consistent with statutory objectives to align financial incentives to support utilization of PCPCHs, in recognition of the standards that are required to be met at different Tiers. (2) Managed care plans and insurance carriers may obtain from the Authority the Tier level recognition of any practice. (3) Within applicable programs, the Authority shall develop and implement reimbursement methodologies that reimburse practices based on recognition of Tier level, taking into consideration incurred practice costs for meeting the Tier criteria. Statutory/Other Authority: ORS 413.042, 413.259 & 414.655 Statutes/Other Implemented: ORS 413.259, 413.260 & 414.655 History: OHP 9-2016, f. & cert. ef. 5-13-16 OHP 2-2012, f. 2-29-12, cert. ef. 3-1-12
409-058-0100 Scope These rules (OAR 409-058-0100 to 409-058-0110) require the Health Evidence Review Commission to adopt bylaws to govern, among other things, the management of potential conflicts of interest, actual conflicts of interest, and significant personal interests among Commissioners, subcommittee members, and appointed ad hoc experts. These rules apply to the Health Evidence Review Commission and its subcommittees as of October 16, 2021. Statutory/Other Authority: ORS 413.042 & 414.689 Statutes/Other Implemented: ORS 414.688 & 414.689 History: OHP 4-2021, adopt filed 11/03/2021, effective 11/03/2021
409-058-0110 Health Evidence Review Commission Bylaws The Health Evidence Review Commission shall adopt bylaws to govern its operations. The bylaws shall, among other things: (1) Require Commission, subcommittee members, and appointed ad hoc experts to disclose potential or actual conflicts of interest as well as other significant personal interests. (2) Specify how potential and actual conflicts of interest will be disclosed and managed. (3) Describe the qualifications for subcommittee membership. Statutory/Other Authority: ORS 413.042 & 414.689 Statutes/Other Implemented: ORS 414.688 & 414.689 History: OHP 4-2021, adopt filed 11/03/2021, effective 11/03/2021
409-060-0100 Scope (1) These rules (OAR 409-060-0100 to 409-060-0150) define criteria and processes that the Health Evidence Review Commission shall use to develop evidence-based reports, including medical technology assessments, evidence-based guidelines and coverage guidances. These rules apply to evidence-based reports and revisions to approved evidence-based reports whose development commences on or after February 1, 2013. (2) The Commission may consider evidence relating to prescription drugs that is relevant to an evidence-based report but may not conduct a drug class evidence review or evidence-based report solely of a prescription drug. Statutory/Other Authority: ORS 414.695 & 413.042 Statutes/Other Implemented: 414.695 & 414.698 History: OHP 4-2013, f. & cert. ef. 2-1-13
409-060-0110 Definitions The following definitions apply to OAR 409-060-0100 to 409-060-0150: (1) “Ad hoc expert” means an individual identified by the Commission as having particular expertise in a technology or its application. (2) “Authority” means the Oregon Health Authority. (3) “Commission” means the Health Evidence Review Commission. (4) “Coverage guidance” means a report approved by the Commission on a health service or technology which makes coverage recommendations for insurers and health care purchasers in furthering the use of evidence-based healthcare. (5) “Evidence-based guideline” means an evidence-based report on a health service or technology, for use by health care providers in encouraging the use of the safest and most effective care possible. (6) “Evidence-based report” means a medical technology assessment, evidence-based guideline or coverage guidance which includes conclusions and recommendations based on the information in the source documents, and which incorporates the clinical context necessary for the information to be properly interpreted by policymakers. (7) “EbGS” means the Evidence-based Guidelines Subcommittee. (8) “HTAS” means the Health Technology Assessment Subcommittee (9) “Medical technology” or “technology” means medical equipment and devices, medical or surgical procedures and other techniques used or prescribed by health care providers in delivering health care to individuals, and the organizational or supportive systems within which health care is delivered. (10) “Medical technology assessment” means an evidence-based report on the use, clinical effectiveness and risks, and cost of a technology in comparison with its alternatives. (11) “Subcommittee” means a subcommittee established by the Commission. (12) “Scientific evidence” means scientific studies found in peer-reviewed medical literature, printed in journals or other publications that publish original manuscripts only after the manuscripts have been critically reviewed by unbiased independent experts for scientific accuracy, validity and reliability. Such evidence will be evaluated by the Commission for evidence of bias based on the current principles of evidence-based medicine. Statutory/Other Authority: ORS 414.695 & 413.042 Statutes/Other Implemented: 414.695 & 414.698 History: OHP 17-2016, f. & cert. ef. 12-22-16 OHP 5-2016, f. & cert. ef. 4-19-16 OHP 4-2013, f. & cert. ef. 2-1-13
409-060-0130 Medical Technology Assessments Medical technology assessments undertaken by the Commission shall be developed by HTAS and may include any technologies listed in the definition in ORS 414.695 and 414.698(1). Medical technology assessments shall be performed in cases where technology assessments from trusted sources do not exist or require the consideration of additional evidence. Medical Technology Assessments shall include a new search of the current peer-reviewed research on the topic. Assessments shall be developed according to the process described in OAR 409-060-0120 except as described in this section. Statutory/Other Authority: ORS 414.695 & 413.042 Statutes/Other Implemented: 414.695 & 414.698 History: OHP 4-2013, f. & cert. ef. 2-1-13
409-060-0140 Evidence-based Guidelines The EbGS shall develop evidence-based guidelines based on one or more existing guidelines which may involve the consideration of additional research. Evidence-based guidelines shall be developed according to the process described in OAR 409-060-0120 except as described in this section. Statutory/Other Authority: ORS 414.695 & 413.042 Statutes/Other Implemented: 414.695 & 414.698 History: OHP 17-2016, f. & cert. ef. 12-22-16 OHP 4-2013, f. & cert. ef. 2-1-13
409-060-0150 Coverage Guidances (1) A Subcommittee shall develop coverage guidances based on evidence searches using scope statements approved by the EbGS or HTAS after a seven-day public comment period. These evidence searches may be supplemented as necessary to provide additional contextual, economic, clinical or policy information based on questions which arise during the development of the coverage guidance. Coverage guidances shall be developed according to the process described in OAR 409-060-0120 except as described in this section. (2) OAR 409-060-0120(3) does not apply to this section. Instead, if the Subcommittee responsible for development of the report determines that it lacks sufficient expertise in the relevant field, or a request is received from an interested outside party, the Subcommittee shall solicit one or more ad hoc experts to provide additional information. Requests from interested parties to appoint ad hoc experts must be submitted within fourteen days after the public notice announcing the subcommittee’s first review of the initial draft coverage guidance. The subcommittee may solicit ad hoc experts at any time thereafter if the committee determines such expertise is necessary. Candidates wishing to serve as ad hoc experts shall disclose conflicts of interest according to HERC bylaws. Ad hoc experts, if needed, shall be appointed by the Authority. The Authority shall select experts that best meet the needs of the state, considering any conflicts of interest, and shall not be limited to those who have volunteered to serve. Ad hoc experts shall answer technical questions and provide clinical context during the review of the evidence. Statutory/Other Authority: ORS 414.695 & 413.042 Statutes/Other Implemented: 414.695 & 414.698 History: OHP 17-2016, f. & cert. ef. 12-22-16 OHP 5-2016, f. & cert. ef. 4-19-16 OHP 4-2013, f. & cert. ef. 2-1-13
409-062-0100 Purpose These rules establish a public notice for advance meeting materials, which must be posted for an advance comment period, before being considered by the Value-based Benefits Subcommittee (VbBS) of the Health Evidence Review Commission (HERC). Public comments help HERC learn about community needs and perspectives to inform its deliberations about coverage recommendations and prioritization of health services. An accessible public comment policy supports HERC’s goals to eliminate health inequities and ensure that covered services are appropriate for the populations affected by its decisions. Statutory/Other Authority: ORS 413.042 Statutes/Other Implemented: ORS 414.688 History: OHP 2-2023, adopt filed 11/09/2023, effective 11/09/2023
409-062-0110 VbBS Meeting Material Requirements (1) Advance meeting materials include draft materials developed by Health Evidence Review Commission (HERC) staff in preparation for a scheduled Value-based Benefits Subcommittee (VbBS) meeting. Each item includes, but is not limited to, an issue summary document which may include staff description of the issue, staff analysis, research, draft recommendations, and/or supporting literature. (2) Advance comment period means a 14-calendar-day period of time for members of the public to review advance meeting materials and to allow time to provide written feedback. (3) Final meeting materials include materials that will be presented to the VbBS subcommittee members at the public meeting. (4) Exempt topics. The following topics are exempt from this advance meeting material notice and comment process: (a) Topics for which there is no recommendation to change the Prioritized List or bylaws. (b) Recommendations related to: (A) Topics placed on a consent agenda related to topics that do not require discussion. (B) Placement or disposition of new medical codes issued by federal authorities fewer than 60 days prior to the meeting. (C) A public health emergency as declared by the state’s Public Health Director or to align with state or federal law. (D) An emergency use authorization by the United States Food and Drug Administration. (E) Coverage changes that require immediate attention as determined by the HERC Director in order to ensure timely access to health care services. (c) Topics for which advance meeting materials were previously posted but for which related recommendations were considered but not approved by VbBS, either as recommended by staff or in revised form. (d) Topics for which advance meeting materials were previously posted and approved by VbBS and which HERC discussed but did not approve either as recommended by VbBS or in revised form. Statutory/Other Authority: ORS 413.042 Statutes/Other Implemented: ORS 414.688 History: OHP 2-2023, adopt filed 11/09/2023, effective 11/09/2023