Loading
 

 

Oregon Bulletin

March 1, 2013

Oregon Health Authority, Office for Oregon Health Policy and Research, Chapter 409

Rule Caption: Prohibition against identifying individuals in public use data sets.

Adm. Order No.: OHP 1-2013

Filed with Sec. of State: 1-24-2013

Certified to be Effective: 2-1-13

Notice Publication Date: 1-1-2013

Rules Amended: 409-021-0130

Subject: The Office for Oregon Health Policy and Research (OHPR) needs to amend these rules in order to improve privacy protections for APAC public use data sets. The amendment prohibits users of APAC public use data from attempting to ascertain the identity of individuals.

Rules Coordinator: Zarie Haverkate—(503) 373-1574

409-021-0130

Requests to Obtain Copies of Public Use Health Data Files

(1) Any requestor who wishes to obtain copies of public use health data files maintained by the Office shall provide all of the following:

(a) Form D-1 (Research Data Request).

(b) Form D-2 (Data Order Form).

(c) Form D-3 (Data Use Agreement).

(d) Full payment of fees.

(2) All requests for public use health data files require the written approval of the Research and Data Manager.

(3) Upon approval and receipt of full payment of fees, one copy of the requested public use health data file will be provided to the requestor.

(4) The Office shall respond to public use health data file requests within a reasonable period of time, except that the Office’s response may be delayed so that critical operations and activities are not unduly disrupted. The Office shall notify the requestor in writing if an extensive delay is anticipated.

(5) This rule shall not apply to health data that the Office routinely makes available for direct download from the Office’s web site.

(6) The public use files may not be used to identify any individual, including but not limited to patients, physicians, and other health care providers. The requestor may not use outside information to attempt to ascertain the identity of particular individuals who are the subject of public use files.

[ED. NOTE: Forms referred are available from the agency.]

Stat. Auth.: ORS 192.440 & 442.420(3)(d)
Stats. Implemented: ORS 192.410 - 192.440, 192.496, 192.501 & 442.420(3)(d)
Hist.: SHPD 5-1986, f. & ef. 1-24-86; HP 2-1988, f. & cert. ef. 3-25-88; HP 2-1992, f. & cert. ef. 10-19-92; HP 2-1994, f. & cert. ef. 4-22-94; HP 1-1996, f. & cert. ef. 1-2-96; OHP 1-1997, f. & cert. ef. 8-25-97; OHP 1-2002, f. & cert. ef. 1-2-02; Renumbered from 409-021-0015, OHP 1-2007, f. 1-29-07, cert. ef. 2-1-07; OHP 1-2013, f. 1-24-13, cert. ef. 2-1-13


 

Rule Caption: Prohibition against identifying individuals in public use data sets.

Adm. Order No.: OHP 2-2013

Filed with Sec. of State: 1-24-2013

Certified to be Effective: 2-1-13

Notice Publication Date: 1-1-2013

Rules Amended: 409-025-0160

Subject: The Office for Oregon Health Policy and Research (OHPR) needs to amend these rules in order to improve privacy protections for APAC public use data sets. The amendment prohibits users of APAC public use data from attempting to ascertain the identity of individuals.

Rules Coordinator: Zarie Haverkate—(503) 373-1574

409-025-0160

Limited and Public Use Data Sets

(1) Public use data sets.

(a) OHPR shall maintain an approved list of data elements, described in Appendix F, that may be included in APAC public use data sets. Appendix F shall comply with applicable Authority policies and state and federal rules, regulations, and statutes.

(b) Requesters seeking access to data from the APAC Public Use Data Sets shall complete an Application for Public Use Data Sets Form (APAC-4) and comply with the application procedures for public use data sets outlined on the APAC website.

(c) OHPR shall approve or deny the completed request and provide written notification to the requester within 30 calendar days of receipt of the request.

(d) OHPR shall deny the completed request for reasons which include, but are not limited to:

(A) Requester or any person who will have access to the data has previously violated a data use agreement with the Authority.

(B) The Administrator finds that the general purpose of the study does not serve the public interest.

(C) The Administrator finds that the specific details of the request do not sufficiently explain the proposed use.

(D) The Administrator finds that the specific details of the request violate any state or federal rule, regulation, or statute.

(E) The Administrator finds that the specific details of the request violate form APAC-4, Section 3: Data Use Agreement.

(F) The Administrator finds that the administrative, technical, and physical safeguards specified in the request do not sufficiently protect the data set.

(G) Full payment is not included with the application.

(e) If OHPR denies the Application for Public Use Data Sets:

(A) OHPR shall provide written notification stating the reason for the denial; and

(B) The requester may appeal the denial by requesting a contested case hearing. The appeal must be filed within 30 business days of the denial. The appeal process is conducted pursuant to ORS chapter 183 and the Attorney General’s Uniform and Model Rules of Procedure, OAR 137-003-0501 to 137-003-0700. The requester shall have the burden to prove that OHPR unreasonably denied the application.

(C) The public use files may not be used to identify any individual, including but not limited to patients, physicians, and other health care providers. The requestor may not use outside information to attempt to ascertain the identity of particular individuals who are the subject of public use files.

(2) Limited data sets.

(a) OHPR shall maintain an approved list of data elements, described in Appendix G, that may be included in APAC limited data sets.

(b) APAC limited data sets may be disclosed for research or to a public health authority for public health purposes.

(c) Researchers seeking access to the APAC Limited Data Sets shall complete an Application for Limited Data Sets Form (APAC-5) and comply with the application procedures for limited data sets outlined on the APAC website.

(d) OHPR shall review all applications for completeness and provide requesters written notification of completeness within 30 calendar days of receipt of the request.

(e) If OHPR determines that the application is incomplete, the requester shall have 30 calendar days from notification of incompleteness to complete the application. Incomplete applications that are not completed shall be discarded without further notification to the requester.

(f) Completed applications shall be made available for public inspection and written comment for no fewer than 14 days.

(g) OHPR shall convene a Privacy and Security Advisory Board to evaluate completed applications for limited data sets.

(A) The Privacy and Security Advisory Board shall include:

(i) Authority’s privacy officer or designee;

(ii) One representative of the Division of Medical Assistance Programs;

(iii) One representative of the Addictions and Mental Health Division;

(iv) One representative of the Public Health Division;

(v) One representative of the Director’s Office;

(vi) One representative of an insurer licensed to transact health insurance in Oregon;

(vii) One representative of a Coordinated Care Organization;

(viii) One representative of a hospital;

(ix) One representative of an ambulatory clinic;

(x) One academic researcher;

(xi) One other interested person not represented above; and

(xii) One non-voting chair, appointed by the Administrator.

(B) OHPR may accept nominations for and make appointments to the Privacy and Security Advisory Board.

(C) The Privacy and Security Advisory Board’s review shall include, but is not limited to:

(i) Whether submitted IRB documentation is sufficient.

(ii) Whether the proposed disclosure serves the public interest.

(iii) Whether the proposed disclosure supports the mission and aims of the Authority.

(iv) Whether the proposed privacy and security protections are sufficient.

(v) Whether additional clarification is needed to complete the review.

(vi) Public comments about the completed application.

(D) When reviewing applications for limited data sets, the Privacy and Security Advisory Board may request any expert testimony that it deems necessary and appropriate.

(h) OHPR shall publish a Privacy and Security Advisory Board meeting schedule on its website and periodically update the number of completed applications scheduled to be reviewed during each meeting.

(i) OHPR shall schedule completed applications for limited data sets for review by the Privacy and Security Advisory Board on a first-come-first-served basis.

(j) The Privacy and Security Advisory Board shall recommend that OHPR approve the application, deny the application, defer action pending expert testimony, or defer action pending clarification from the requester.

(k) OHPR shall accept or reject the Privacy and Security Advisory Board’s recommendation and notify the requester within ten business days of the review.

(l) OHPR shall deny a completed application for reasons which include, but are not limited to:

(A) Requester or any person who will have access to the data has previously violated a data use agreement with the Authority.

(B) Full payment is not included with the application.

(m) If the Privacy and Security Advisory Board requests clarification, the requester shall have 30 calendar days to provide the requested information to OHPR. After 30 calendar days, applications with incomplete requests for clarification shall be discarded without further notification to the requester.

(n) Upon receipt of the requested clarification OHPR shall schedule re-evaluation with the Privacy and Security Advisory Board on a first-come-first-served basis.

(o) If OHPR denies the application:

(A) OHPR shall provide written notification stating the reason for the denial.

(B) The requester may appeal the denial by requesting a contested case hearing. The appeal must be filed within 30 business days of the denial. The appeal process is conducted pursuant to ORS Chapter 183 and the Attorney General’s Uniform and Model rules of Procedure, OAR 137-003-0501 to 137-003-0700. The requester shall have the burden to prove that OHPR unreasonably denied the application.

Stat. Auth.: ORS 442.466
Stats. Implemented: ORS 442.464 & 442.466
Hist.: OHP 1-2010, f. 2-26-10, cert. ef. 3-1-10; OHP 4-2012, f. 5-23-12, cert. ef. 6-1-12; OHP 2-2013, f. 1-24-13, cert. ef. 2-1-13


 

Rule Caption: Amendment to the Physician VISA Waiver Program

Adm. Order No.: OHP 3-2013

Filed with Sec. of State: 1-24-2013

Certified to be Effective: 2-1-13

Notice Publication Date: 1-1-2013

Rules Amended: 409-035-0020

Subject: The Office for Oregon Health Policy and Research needs to amend OAR 409-035-0020 to allow Federally-Qualified Health Centers (FHQCs) with a HPSA score at or above the requirements of 22 CFR 41.63 to apply for a J-1 Waiver through the Authority.

Rules Coordinator: Zarie Haverkate—(503) 373-1574

409-035-0020

Health Care Facility Participation Requirements

(1) Federally Qualified Health Centers with a:

(a) HPSA score at or above the requirements of 22 CFR 41.63 shall apply for a J-1 Waiver either through the Authority or through the United State Department of Health and Human Services (see: http://www.globalhealth.gov/global-programs-and-initiatives/exchange-visitor-program);

(b) HPSA score below the requirements of 22 CFR 41.63 shall apply for a J-1 Waiver through the Authority.

(2) If a health care facility is located in a Medically Underserved Area (MUA) or Medically Underserved Population (MUP) that is not a Health Professional Shortage Area (HPSA), or if the request is for a flex option, then the facility must obtain prior approval from the Authority and provide documentation substantiating the area’s need for a physician.

(3) In order to qualify for the Oregon Physician Visa Waiver Program the health care facility must:

(a) Identify the nature of the business entity seeking to employ the physician, including but not limited to domestic or foreign professional corporation, domestic or foreign private corporation, LLC, or partnership, and provide a certificate of existence or proof of authorization to do business in Oregon;

(b) Have provided care for a minimum of six months in Oregon, or supply evidence of stability such as HRSA funding, prior to submitting an application;

(c) Currently serve Medicare, Medicaid, and low income uninsured patients that are members of the population of the local HRSA designation. A minimum of 20% of the total current patient visits must be Medicaid, Medicare, or other low-income patients. At least half of the 20% requirement, i.e. 10%, must be Medicaid and low income uninsured patients, excluding Medicare.

(d) Post a sliding fee schedule in the primary languages of the population being served;

(e) Document attempts to actively recruit an American doctor for at least six months prior to submission of the application;

(f) Execute an employment contract with the physician that includes the following provisions:

(A) Duration of at least three years;

(B) Wages and working conditions comparable to those for a graduate from an American medical school;

(C) A signed U.S. Department of Labor Prevailing Wage Form (ETA-9035);

(D) May not include a non-compete clause or restrictive covenant that prevents or discourages the physician from continuing to practice in any designated area after the term of the contract expires;

(E) Specifies the geographic shortage area within Oregon in which the physician will practice or, if requesting a flex option, the shortage area or areas where prospective patients live;

(F) The physician shall treat all patients regardless of their ability to pay;

(G) The physician shall provide patient care on a full-time basis, a minimum of 40 hours per week;

(4) The health care facility shall submit to the Authority a fee of $2,000 and two original copies of the application packet for each waiver requested.

Stat. Auth.: ORS 413.248
Stats. Implemented: ORS 413.248
Hist.: PH 14-2003(Temp), f. 9-25-03 cert. ef. 10-1-03 thru 3-29-04; PH 11-2004, f. 3-25-04, cert. ef. 3-29-04; Renumbered from 333-005-0020 by OHP 7-2010, f. 12-29-10, cert. ef. 1-1-11; OHP 3-2013, f. 1-24-13, cert. ef. 2-1-13


 

Rule Caption: Health Evidence Review Commission Process for Evidence-based Reports

Adm. Order No.: OHP 4-2013

Filed with Sec. of State: 2-1-2013

Certified to be Effective: 2-1-13

Notice Publication Date: 1-1-2013

Rules Adopted: 409-060-0100, 409-060-0110, 409-060-0120, 409-060-0130, 409-060-0140, 409-060-0150

Subject: The Office for Oregon Research and Development needs to adopt rules to document the process the Health Evidence Review Commission (HERC) will follow in developing medical technology assessments and other evidence based reports based on comparative effectiveness research so that the public and interested stakeholders understand what to expect from the Commission and know how to best provide input into the process.

Rules Coordinator: Zarie Haverkate—(503) 373-1574

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.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: 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) “Commission” means the Health Evidence Review Commission.

(3) “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.

(4) “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.

(5) “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.

(6) “EbGS” means the Evidence-based Guidelines Subcommittee.

(7) “HTAS” means the Health Technology Assessment Subcommittee

(8) “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.

(9) “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.

(10) “OHPR” means the Office for Oregon Health Policy and Research.

(11) “Subcommittee” means a subcommittee established by the Commission.

(12) “Trusted source” means a source designated by the Commission for use in developing an evidence-based report.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

409-060-0120

Health Evidence Review Commission Process for Evidence-based Reports

(1) The Commission shall develop evidence-based reports or may direct a Subcommittee to prepare these reports. The Commission shall identify reports from trusted sources to serve as the basis for these reports. Meetings shall be public and conducted in a manner consistent with the Commission’s policies and procedures.

(2) Topics for review shall be publicly identified at least 30 days prior to the initial Subcommittee meeting at which a draft evidence-based report is reviewed. In this notice, the Subcommittee shall make publicly available the primary evidence source documents to be used in creating the initial draft report, except when source documents are proprietary. If additional sources are added to the initial draft report after this notice, the Subcommittee shall publicly identify them no later than 14 days prior to the Subcommittee meeting where they will be discussed. In lieu of proprietary source documents, the Subcommittee shall make publicly available a citation of the evidence source. In the case of a proprietary evidence source, a full listing of citations from the proprietary source shall be made available when allowed by the source. If providing the citations is not allowed or not otherwise feasible, a summary of the evidence findings will be provided at least 14 days in advance of the meeting at which the initial draft report will be discussed.

(3) When developing an evidence-based report, the Commission or its designated Subcommittee shall consult with two or more ad hoc experts on the subject matter of the evidence-based report. Subcommittee shall publicly solicit ad hoc experts at least 30 days prior to the meeting at which it reviews the initial draft evidence-based report. One of the ad hoc experts must be a provider who manages patients who would potentially receive the treatment, service or device in question. Candidates wishing to serve as ad hoc experts shall disclose conflicts of interest according to HERC bylaws. The OHPR Administrator shall appoint ad hoc 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.

(4) After the Subcommittee reviews the initial draft report, the subcommittee may revise the initial draft report. The Subcommittee shall then solicit public comment on this version of the draft report over a 30-day period. Draft reports posted for comment shall include citations for all sources used in developing the report and a summary of evidence findings. The Subcommittee shall publicly disclose written comments received during the 30-day period, draft responses and additional revisions(if any) to the draft report at least seven days before the Subcommittee meeting at which the Subcommittee reviews public comments. After discussing the available evidence and considering public comment, including additional verbal testimony, the Subcommittee shall make conclusions as to the overall importance of beneficial effects versus potential harms and approve its final draft evidence-based report reflecting these conclusions.

(5) Before an evidence-based report is reviewed at a Commission meeting, a final draft report approved by the Subcommittee, along with all written public comments received during the public comment period and the Subcommittee’s responses to these public comments shall be made publicly available for a period of at least 14 days. At the meeting, the Commission shall consider the Subcommittee’s approved draft report and accept further public comment.

(6) After evaluating the report and public comments the Commission may take one of three actions:

(a) Accept the report as written.

(b) Make edits to the report and accept as modified.

(c) Return the report to the Subcommittee with recommendations for further work.

(7) The Commission or its Subcommittees may revise evidence-based reports when additional information relevant to the report becomes available or if the findings of one or more of the source reports change. The Commission or its Subcommittees may initiate a review at the request of interested parties who provide information or interpretations not considered in developing an existing evidence-based report. At a minimum, the HERC or one of its Subcommittees shall review the need to update each report within two years after its adoption or most recent revision.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: 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.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: 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 guideline from trusted sources, 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.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

409-060-0150

Coverage Guidances

(1) A Subcommittee shall develop coverage guidances which shall be based on reports developed by trusted sources, and may cite supplemental evidence which is more recent or beyond the scope of the report. 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 an ad hoc expert 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 OHPR Administrator. The OHPR administrator 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.

Stat. Auth.: ORS 414.695 & 413.042
Stats. Implemented: 414.695 & 414.698
Hist.: OHP 4-2013, f. & cert. ef. 2-1-13

Notes
1.) This online version of the OREGON BULLETIN is provided for convenience of reference and enhanced access. The official, record copy of this publication is contained in the original Administrative Orders and Rulemaking Notices filed with the Secretary of State, Archives Division. Discrepancies, if any, are satisfied in favor of the original versions. Use the OAR Revision Cumulative Index found in the Oregon Bulletin to access a numerical list of rulemaking actions after November 15, 2012.

2.) Copyright 2013 Oregon Secretary of State: Terms and Conditions of Use

Oregon Secretary of State • 136 State Capitol • Salem, OR 97310-0722
Phone: (503) 986-1523 • Fax: (503) 986-1616 • oregon.sos@state.or.us

© 2013 State of Oregon All Rights Reserved​