333-010-0000
Cancer Reporting Regulations: Definitions

(1) "Active follow-up program" means a program for a health care facility to determine, at least annually, information including but not limited to the vital status of each case.

(2) "Admitted" means a rendering of any service by the health care facility to a patient under the authority or auspices of the facility's license under ORS 441.015, including but not limited to routine admission to the hospital, admission to the emergency room, or receiving services in an out-patient clinic.

(3) "Authority" means the Oregon Health Authority.

(4) "Central cancer registry" means the Oregon Health Authority, Public Health Division program authorized to collect, receive, and maintain cancer data for the entire state and which maintains the system by which the collected information is reported to the Division.

(5) "Central Cancer Registry Notification Form" means the form required for practitioners to report a case of reportable cancer or reportable non-malignant condition.

(6) "Certified tumor registrar" means an individual who passes the certification examination and is currently certified by the Council on Certification of the National Cancer Registrars Association which provides the education and skills needed to fully abstract a cancer case.

(7) "Clinical laboratory" means a facility where microbiological, serological, chemical, hematological, immunohematological, immunological, toxicological, cytogenetical, exfoliative cytological, histological, pathological or other examinations are performed on material derived from the human body, for the purpose of diagnosis, prevention of disease or treatment of patients by physicians, dentists and other persons who are authorized by license to diagnose or treat humans.

(8) "Date of diagnosis" means the date of initial diagnosis by a practitioner for the cancer being reported.

(9) "Division" means the Public Health Division of the Oregon Health Authority.

(10) "First course of treatment" means all methods of treatment recorded in the treatment plan and administered to a person with a case of reportable cancer or reportable non-malignant condition before disease progression or recurrence, as defined in the American College of Surgeons Commission on Cancer Oncology Registry Data Standards Manual that is for the current year of diagnosis.

(11) "Health care facility" means a hospital, as defined in ORS 442.015, or an ambulatory surgical center, as defined in ORS 442.015 or any other facility in which patients are diagnosed or provided treatment for cancer or benign or borderline tumors of the brain and central nervous system.

(12) "Health system cancer registry" means a cancer registry maintained by a health system that includes all reportable cancer cases occurring in the population served by the health system, whether or not the cases are diagnosed or treated in the health system’s health care facilities.

(13) "OSCaR" means the Oregon State Cancer Registry and has the same meaning as "central cancer registry".

(14) "Practitioner" means any person whose professional license allows the person to diagnose or treat cancer patients.

(15) "Quality control system" means operational procedures by which the accuracy, completeness, and timeliness of the information reported to OSCaR can be determined and improved.

(16) "Reportable cancer" means all malignant neoplasms including carcinoma in situ, except basal and squamous cell carcinoma of the skin, carcinoma in situ of the cervix uteri, CIN III (diagnosed on or after January 1, 1996), and PIN III (diagnosed on or after January 1, 2001).

(17) "Reportable Cancer Data Items List" means the list of variables for reportable cancers and reportable non-malignant conditions reported by health care facilities following the recommendations of the Centers for Disease Control and Prevention National Program of Cancer Registries ("CDC-NPCR") and further defined by the North American Association of Central Cancer Registries ("NAACCR") Data Standards and Data Dictionary, available on the Oregon State Cancer Registry website: www.healthoregon.org/oscar.

(18) "Reportable non-malignant condition" means benign or borderline tumors of the brain (including the meninges and intracranial endocrine structures) and central nervous system, diagnosed on or after January 1, 2004.

(19) "Reportable pre-malignant condition" means all high-grade squamous intraepithelial lesion (CIN 2,3) and adenocarcinoma in situ (AIS) of the uterine cervix, high-grade squamous intraepithelial lesion of the vagina and vulva (VAIN 2,3/VIN 2,3), and high-grade squamous intraepithelial lesion (AIN 2,3) and carcinoma in situ of the anus.

(20) "Special study" means a Division-sponsored project that explores a particular facet of cancer incidence, morbidity, or mortality including, but not limited to, exploring hypotheses of disease risk, treatment options or cancer control authorized under ORS 432.520.

Statutory/Other Authority: ORS 432.500, 432.510 & 432.540
Statutes/Other Implemented: ORS 432.510, 432.520 & 432.540
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98
HD 2-1996, f. & cert. ef. 2-29-96

333-010-0020
Cancer Reporting Regulations: Reporting Requirements for Health Care Facilities

This rule describes the specific requirements for health care facilities. Such facilities include inpatient facilities, outpatient facilities acting under the license of a hospital, ambulatory surgical centers, privately owned treatment or diagnostic centers contracted to and acting as a department of a health care facility or any other facility in which patients are diagnosed or provided treatment for cancer or benign or borderline tumors of the brain and central nervous system.

(1) Health care facilities must report to OSCaR each case of reportable cancer or reportable non-malignant condition, as defined in OAR 333-010-0000(16) and 333-010-0000(18) respectively, in patients admitted for diagnosis or any part of the first course of treatment for that cancer. OSCaR will make lists of reportable cancers and reportable non-malignant conditions available on the Oregon State Cancer Registry website: www.healthoregon.org/oscar.

(2) Health care facilities must report cases of reportable cancer or reportable non-malignant conditions to OSCaR as stipulated in OAR 333-010-0020(1) within 180 days of the date the case first receives cancer diagnostic or treatment services at the facility.

(3) Health care facilities with an active follow-up program must annually report vital status, date of last patient contact, and, if available, cancer or tumor status of reportable cancers and reportable non-malignant conditions to OSCaR.

(4) Health care facilities must report their cases of reportable cancer or reportable non-malignant conditions and any follow-up information to OSCaR in the electronic data exchange format and codes, Record Type A: Case Abstract, as specified by NAACCR, including the variables specified in the Reportable Cancer Data Items List. The OSCaR Reportable Data Items List will be available on the Oregon State Cancer Registry website: www.healthoregon.org/oscar.

(5) OSCaR shall establish a system of confirmation of receipt of cases submitted by each health care facility.

(6) Health care facilities reporting cases of reportable cancer or reportable non-malignant conditions to a health system cancer registry have discharged their reporting responsibilities provided that the health system registry reports those cases to OSCaR according to the requirements for health care facilities.

(7) Health care facilities may also elect to contract with a private vendor or contractor to report cases of reportable cancer and reportable non-malignant conditions to OSCaR as outlined above in OAR 333-010-0020(1) through (4).

(8) Any health care facility designated as a Type A or Type B rural hospital by the Oregon Office of Rural Health, may elect to meet the cancer reporting requirements by conducting their own identification of cases of reportable cancer and reportable non-malignant conditions and mailing a copy of the relevant portions of the medical record for each case to the central cancer registry. The central cancer registry staff will abstract and report such cases and bill the hospital for this service at its cost. Type A or Type B rural hospitals which authorize the central cancer registry to abstract and report cases have fulfilled their abstracting and reporting requirements under these rules.

(9) Upon application to OSCaR by a health care facility, OSCaR may grant to the facility an extension of time, not to exceed one year, in which to meet the reporting requirements. Such requests must be in writing and directed to the state central cancer registry manager, with a copy to the State Health Officer at the Division. On request, the central cancer registry staff shall provide technical assistance to facilities to meet the reporting requirements.

(10)(a) If cancer reports from a health care facility do not meet reporting requirements, OSCaR shall inform the facility in writing of the disparity between the facility's reports and the reporting standards. OSCaR will then consult with the facility regarding its options for meeting the reporting standards, as defined in OAR 333-010-0020(1) through (4). Options shall include, but are not limited to:

(A) Further consultation and training;

(B) Referral to contractors for reporting services;

(C) Provision, at cost, of reporting services by OSCaR. By selecting this option, health care facilities will fulfill all reporting requirements as defined in OAR 333-010-0090.

(b) If, after a minimum of 30 days from the receipt of the written notification, the facility cannot meet the reporting requirements, OSCaR may activate its reporting service for the facility. When activated, OSCaR may enter the facility, obtain the information and report it in conformance with the appropriate format and standards. In these instances, the facility shall reimburse OSCaR or its authorized representative for the cost of obtaining and reporting the information.

Statutory/Other Authority: ORS 432.510, 432.520 & 432.570
Statutes/Other Implemented: ORS 432.510 & 432.520
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98
HD 2-1996, f. & cert. ef. 2-29-96

333-010-0030
Cancer Reporting Regulations: Reporting Requirements for Practitioners

(1) Any practitioner diagnosing a case of reportable cancer or a reportable non-malignant condition, as defined in OAR 333-001-0000(16) and 333-010-0000(18) respectively, must notify OSCaR of each such case within 180 days of the diagnosis of the case. OSCaR will make lists of reportable cancers and reportable non-malignant conditions available on the Oregon State Cancer Registry website: www.healthoregon.org/oscar.

(2) Data items required for reporting a case of reportable cancer or reportable non-malignant condition shall include, but not be limited to, cancer diagnosis and treatment information, patient demographics, and practitioner contact information, as specified on the Central Cancer Registry Notification Form. Copies of the Central Cancer Registry Notification Form will be available on the Oregon State Cancer Registry website: www.healthoregon.org/oscar.

(3) Practitioners must comply with one of the following optional notification methods as may be directed by OSCaR:

(a) Completion and submission (by mail or facsimile) of the Central Cancer Registry Notification Form; or

(b) An encrypted electronic communication directed to OSCaR containing the information required by the Central Cancer Registry Notification Form.

(4) Practitioners do not need to report any case admitted to an Oregon health care facility within 180 days of diagnosis for:

(a) A diagnosis of a reportable cancer or reportable non-malignant condition; or

(b) All or any part of the first course of treatment for that case, providing that admission to the facility occurs within 180 days of diagnosis.

(5) Practitioners reporting cases of reportable cancer and reportable non-malignant conditions to a health system cancer registry have executed their reporting responsibilities provided that the health system cancer registry reports those cases to OSCaR according to the requirements for health care facilities.

(6) If a practitioner fails to notify OSCaR of cases of reportable cancer and reportable non-malignant conditions according to the standards and format prescribed for practitioners, OSCaR may inform the practitioner in writing of the disparity between the practitioner's reporting performance and the reporting standards and consult with the practitioner regarding methods for bringing the practitioner's reporting performance into compliance with the reporting standards.

(7) If OSCaR does not receive information from another source completing the information required for a case of reportable cancer or reportable non-malignant condition submitted by a practitioner, or if OSCaR learns of an unreported case for which the practitioner has reporting responsibility but of which the central cancer registry has not been notified by the practitioner, OSCaR may notify the practitioner of the missing information or case and the practitioner must, within 30 days, submit requested additional information to OSCaR. In the alternative, OSCaR may contact the practitioner and schedule a time to abstract the necessary data from the practitioner's records. The practitioner must provide access to those portions of a patient's medical record which provide data for the items specified in the Reportable Cancer Data Items List. In these instances, the practitioner must reimburse OSCaR or its authorized representative for the cost of obtaining and reporting the information.

(8) OSCaR shall establish a system of confirmation of receipt of cases submitted by practitioners.

Statutory/Other Authority: ORS 432.510 & 432.520
Statutes/Other Implemented: ORS 432.510 & 432.520
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98
HD 2-1996, f. & cert. ef. 2-29-96

333-010-0032
Cancer Reporting Regulations: Reporting Requirements for Clinical Laboratories

(1) Clinical laboratories must report to OSCaR all cases with test results indicative of and specific for a reportable cancer or reportable non-malignant condition, as defined in OAR 333-010-0000(16) and 333-010-0000(18) respectively, ("Cancer Pathology Reports") in accordance with the following provisions. Clinical laboratories must submit all Cancer Pathology Reports to OSCaR using the electronic data exchange format and codes set forth in the guidelines for Pathology Laboratory Electronic Reporting issued by the North American Association of Central Cancer Registries ("NAACCR"), unless reported to a health system cancer registry. The NAACCR Guidelines for Pathology Laboratory Electronic Reporting are available from OSCaR.

(2) Clinical laboratories must also report to OSCaR all cases with biopsies (excluding cytologic tests) indicative of and specific for a reportable pre-malignant condition, as defined in OAR 333-010-0000(16), in an electronic format directed by OSCaR. These reports must include (if available to the clinical laboratory):

(a) Name, address, and telephone number of the physician listed on the lab order;

(b) Name, address, and telephone number of the reporting laboratory;

(c) Patient name, gender, address (if available), birth date, race/ethnicity;

(d) Primary site and type of cancer-related condition; and

(e) Date of diagnosis.

(3) OSCaR will make lists of reportable cancers, reportable non-malignant conditions, and reportable pre-malignant conditions available on the Oregon State Cancer Registry website: www.healthoregon.org/oscar. If a clinical laboratory fails to submit the required cancer pathology reports or reports of pre-malignant conditions to OSCaR according to the standards and format prescribed, OSCaR may inform the laboratory in writing of the disparity between the laboratory’s reporting performance and the reporting standards and consult with the laboratory regarding methods for bringing the clinical laboratory’s reporting performance into compliance with the reporting standards.

(4) If a clinical laboratory is not able to submit cancer pathology reports or reports of pre-malignant conditions electronically, OSCaR may authorize the clinical laboratory to report by mail or facsimile for a limited period of time to be specified by OSCaR.

(5) OSCaR shall establish a system of confirmation of receipt of cancer pathology reports and reports of pre-malignant conditions submitted by clinical laboratories.

Statutory/Other Authority: ORS 432.510 & 432.520
Statutes/Other Implemented: ORS 432.510 & 432.520
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0035
Cancer Reporting Regulations: Patient Notification Requirement

This rule describes the process for notifying patients that information about a reportable cancer has been reported to OSCaR.

(1) OSCaR may, but is not required to notify patients that information about a diagnosis of reportable cancer has been included in the registry. OSCaR may make a determination, based on budgeting constraints or otherwise, to curtail patient notification activities.

(2) Information to be provided to patients. The notification to the patient shall include the following information about the purposes of the registry and the protection of confidentiality:

(a) That Oregon statute requires that every cancer newly diagnosed in Oregon, or in an Oregon resident, be reported to the Oregon State Cancer Registry maintained by Oregon Health Authority;

(b) That information reported to the Authority includes the type and characteristics of the cancer, details of the diagnosis and treatment given, and patient demographic information;

(c) That the information is used to understand how cancer affects the population in Oregon, to design and implement prevention and control programs, and for research;

(d) That the information is confidential and no identifiable information about the patient can be released to anyone unless very strict requirements, as provided by law, are met;

(e) If those specific requirements, as provided by law, are met, researchers may be allowed to contact patients to offer them the opportunity to participate in research projects. Any invitation to participate in research is always voluntary and may be freely declined; and

(f) That the researcher shall first notify the patient's physician regarding the patient’s participation in a research project, unless the patient specifies to OSCaR that their name never be released for any research purpose.

Statutory/Other Authority: ORS 432.500
Statutes/Other Implemented: ORS 432.500–432.900
History:
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98

333-010-0040
Cancer Reporting Regulations: Quality Standards

The usefulness of OSCaR data is directly dependent upon the accuracy, completeness, and timeliness of the data available in its database. ORS 432.510 directs the Oregon Health Authority to establish a quality control system for the data reported to the state registry. In order to assess these aspects of quality for cancer reporting, the central cancer registry will institute a program of continuous quality improvement.

(1) The continuous quality control system must include, but is not limited to, assessing coding edits, completeness audits or checks, reabstracting audits, and data analysis techniques to estimate data accuracy, validity, and reliability. OSCaR may provide training and corrective measures to improve data accuracy, validity, and reliability.

(2) For the purpose of assuring the accuracy and completeness of reported data:

(a) OSCaR shall have the right to periodically review all records that would identify cases of reportable cancer and reportable non-malignant conditions or would establish characteristics of the cancer, treatment of the cancer or the medical status of any identified cancer patient. OSCaR will provide advance notification of a minimum of 30 days, to allow time for the reporting sources to prepare records for review.

(b) When a patient has been seen for care or diagnosis by multiple reporting facilities, practitioners, or clinical laboratories, OSCaR may communicate with the reporting facilities, providers and laboratories to evaluate the accuracy of data reported. OSCaR may disclose confidential cancer data to a health care facility, practitioner, or laboratory to correct, complete, or improve the accuracy of the reported data.

(3) The collection of cancer data from health care facilities, including data collection performed by OSCaR staff, must be performed either by certified tumor registrars or by staff knowledgeable about the following, as recommended by the American College of Surgeons, Commission on Cancer:

(a) Cancer as a disease process;

(b) General anatomy and physiology;

(c) Cancer epidemiology and statistics;

(d) Casefinding procedures; and

(e) Basic coding and staging schemes.

(4) A health care facility must report a minimum of 98 percent of the cases reportable by that facility for any calendar year in order to meet the requirement of these rules.

(5) The item-specific agreement rate of reported data from a health care facility with the information in the facility's medical record must not be less than 95 percent for those data items identified in the OSCaR Reportable Data Items list as quality control items.

(6) A health care facility must submit 98 percent of reportable cases to the central cancer registry within 180 days of either:

(a) The date of diagnosis; or

(b) The date of admission for receipt of any part of the first course of treatment provided in that facility, whichever is later.

(7) A practitioner must submit a minimum of 95 percent of reportable cases to the central cancer registry within 180 days of the date of diagnosis.

Statutory/Other Authority: ORS 432.510 & 432.520
Statutes/Other Implemented: ORS 432.510 & 432.520
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
HD 2-1996, f. & cert. ef. 2-29-96

333-010-0050
Cancer Reporting Regulations: Confidentiality and Access to Data

This rule describes when confidential and privileged information collected and maintained by OSCaR may be shared and the process for obtaining aggregate non-confidential OSCaR information that is not publically available.

(1) All identifying information regarding individual patients, health care facilities, clinical laboratories, and practitioners reported pursuant to ORS 432.510 and 432.520, OAR 333-010-0020, 333-010-0030 and 333-010-0032 shall be confidential and privileged. Except as required in connection with the administration or enforcement of public health laws or rules, no public health official, employee, or agent shall be examined in an administrative or judicial proceeding as to the existence or contents of data collected under the cancer registry system.

(2) The information collected and maintained by OSCaR must be stored in secure locations, must be used solely for the purposes stated in ORS 432.510 and 432.520 and must not be further disclosed unless required by law, with the following exceptions:

(a) When OSCaR has entered into reciprocal cooperative agreements with other states to exchange information on resident cases, as provided for in ORS 432.540. Such agreements must provide for obtaining data on Oregon resident cases diagnosed or treated out of state, and for reciprocal rights of other states to receive information on residents of those states diagnosed or treated in Oregon. Before entering into an agreement with any other state, OSCaR must determine that the other state has comparable confidentiality protections;

(b) When disclosure to officers or employees of federal, state, or local government public health agencies is necessary to investigate or avoid a clear and immediate danger to other individuals or to the public generally;

(c) When the Authority elects to contract with another agency for performance of a registry function the Authority will require the contractor to agree to use the information only for the purposes of the central cancer registry, to maintain the information securely, and to protect the information from unauthorized disclosure as referred to in OAR 333-010-0050(1). Before entering into any contract with another agency the Authority must determine the agency has comparable confidentiality protections; and

(d) When the Authority deems that the information is necessary for others to conduct research in conformance with the purposes for which the data are collected.

(3) Health care facilities shall have access to confidential and privileged data on any case submitted by that facility. When a patient has been seen for care by multiple health care facilities, OSCaR may share corrected or amended information among the reporting facilities due to the data standards and accuracy needed for each cancer case.

(4) Practitioners shall have access to confidential and privileged data on any case submitted by that practitioner. When a patient has been seen for care of a case of cancer by multiple practitioners, OSCaR may share information on treatment and follow-up among the practitioners, provided that all participating practitioners have signed agreements with OSCaR to do so.

(5) Access to non-confidential OSCaR data combined from multiple cancer cases and summarized as counts and rates that is not publically available is limited as follows:

(a) Requestor shall make a formal request to OSCaR;

(b) Requestor agrees to acknowledge OSCaR as the data source in any report or publication where the data is used;

(c) County is the smallest unit of geography for which data will be released; and

(d) Data will be suppressed based upon OSCaR’s current confidentiality standard.

Statutory/Other Authority: ORS 432.510 & 432.520
Statutes/Other Implemented: ORS 432.530 & 432.540
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98
HD 2-1996, f. & cert. ef. 2-29-96

333-010-0055
Cancer Reporting Regulations: Research Studies

(1) Requirements for Research Studies. Before any confidential data may be disclosed to a researcher, OSCaR must:

(a) Approve a submitted protocol for the proposed research, which describes how the research will be used to determine the sources of cancer among the residents of Oregon or to reduce the burden of cancer in Oregon, in accordance with ORS 432.510 and OAR 333-010-0010;

(b) Agree that the data requested are necessary for the effective and efficient conduct of the study;

(c) Approve the researcher's submitted protocol and procedures for:

(A) Identifying patients to be contacted;

(B) Protecting against inadvertent disclosure of confidential and privileged data;

(C) Providing secure conditions to use and store the data;

(D) Assuring that the data will only be used for the purposes of the study; and

(E) Assuring that confidential and privileged data will be destroyed upon conclusion of the research;

(d) Determine that the researcher has access to sufficient resources to carry out the proposed research before releasing any confidential data;

(e) Confirm appropriate review of the research, including peer review for scientific merit, and review by the body used by the Authority as the Committee for the Protection of Human Research Subjects and established in accordance with 45 C.F.R. 46:

(A) A researcher’s proposed study must comply with the requirements of the Federal Policy for the Protection of Human Subjects codified at 45 C.F.R. 46 as a condition of receiving confidential information from OSCaR.

(B) The Committee must evaluate studies under 45 C.F.R. Part 46’s requirements for disclosure and must approve the study prior to OSCaR releasing any data.

(f) Determine the need for and require the researcher to implement other safeguards which, in the judgment of OSCaR, may be necessary for protecting confidential and privileged data from inadvertent disclosure due to unique or special characteristics of the proposed research.

(2) Contacting Patients for Research. As outlined in OAR 333-010-0035(2)(e) and (f), participation in research is voluntary and patients may choose whether or not they want to participate in research studies.

(a) Before disclosing confidential patient information to a researcher, OSCaR must determine whether any of the patients meeting the criteria for the research study have previously informed OSCaR that they do not wish to participate in research. Such patients will be excluded from the list of patients provided to the researcher or contacted by OSCaR regarding research.

(b) Patients may be contacted a maximum of one time per year. Patients who meet the criteria for the research study and have been contacted for any OSCaR-related research study within a year preceding the initiation of the patient contact process for the research study will be excluded from the list of patients provided to the researcher or contacted by OSCaR regarding research.

(c) Unless OSCaR determines it to be impracticable, OSCaR or the researcher must contact the patient's current treating physician to inform them of the study prior to any contact with a patient. In situations where the treating physician of record is no longer the patient's physician, OSCaR or the researcher must make a good faith effort to find the patient's current physician.

(d) When contacted, the patient’s physician must be informed of the study and the identity of the eligible patient. Within three weeks the physician must:

(A) Agree that direct contact by the researcher would be appropriate; or

(B) Indicate the presence of a medical, psychological or social situation in the patient's life that would make contact inappropriate at that time. The physician is under no obligation to disclose the specifics of the medical, psychological or social situation.

(e) If a researcher does not receive a response from the physician within one month, the researcher may contact the patient directly.

(f) When a researcher contacts a patient directly, the researcher must include information explaining the registry, why the patient’s contact information was disclosed, and the purpose of the disclosure.

(g) Researchers are strictly prohibited from redisclosing patient names or other confidential information to other researchers, individuals, or institutions not specifically identified in the approved study protocol as outlined above.

Statutory/Other Authority: ORS 432.510, 432.530 & 432.540
Statutes/Other Implemented: ORS 432.510, 432.530 & 432.540
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98

333-010-0060
Cancer Reporting Regulations: Special Studies

(1) From time to time, OSCaR may elect to conduct special studies of cancer mortality, morbidity, treatment options and cancer control. OSCaR is specifically authorized to obtain any information which may apply to a patient's reportable cancer or reportable non-malignant condition, and which may be found in the medical record of the patient under ORS 432.510 and 432.520. Upon request, the practitioner or health care facility must provide the requested information to OSCaR or provide OSCaR personnel access to the relevant portions of the medical records. Neither OSCaR nor the record holder shall bill the other for the cost of providing or obtaining this information.

(2) If, in the conduct of a special study, OSCaR identifies a need for access to pathological specimens that have been collected in connection with a case, OSCaR must make a written request to the clinical laboratory or the health care facility with which the clinical laboratory is affiliated for the purpose of making arrangements for the procurement of such pathological specimens upon mutually agreeable terms.

Statutory/Other Authority: ORS 432.510 & 432.520
Statutes/Other Implemented: ORS 432.510 & 432.520
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
HD 2-1996, f. & cert. ef. 2-29-96

333-010-0070
Cancer Reporting Regulations: Advisory Committee

The Authority shall appoint an advisory committee to review the operations of the central registry and to make recommendations regarding registry policy, and to review research protocols for which confidential and privileged data are requested. The composition of the advisory committee must generally represent those with a professional or personal interest in cancer.

Statutory/Other Authority: ORS 432.510 & 432.520
Statutes/Other Implemented: ORS 432.510
History:
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
HD 2-1996, f. & cert. ef. 2-29-96

333-010-0080
Cancer Reporting Regulations: Training and Consultation

The Authority shall provide annual continuing education for interested persons involved in cancer registry reporting. Continuing education content must include, but is not limited to, cancer diagnosis and management, epidemiology and statistics, and hardware and software registry applications. The central cancer registry staff must supplement the continuing education with one-on-one consultations to assist health care facilities and practitioners as needed in meeting the reporting requirements.

Statutory/Other Authority: ORS 432.510
Statutes/Other Implemented: ORS 432.510
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
PH 13-2011, f. 12-28-11, cert. ef. 1-1-12
HD 2-1996, f. & cert. ef. 2-29-96

333-010-0090
Cancer Reporting Regulations: Fees

This rule describes the process by which the Authority will calculate the cost of providing cancer reporting services to health care facilities, practitioners or clinical laboratories. For health care facilities, practitioners and clinical laboratories that are not in compliance with cancer reporting requirements, the Authority may elect to provide reporting services at cost. The Authority may also provide reporting services at the option of a health care facility, practitioner or clinical laboratory.

(1) The Authority may charge a fee reasonably calculated to reimburse the Authority for the cost of providing cancer reporting services to health care facilities:

(a) Costs include but are not limited to the services, supplies and time spent in:

(A) Entering the health care facility, including transportation costs;

(B) Obtaining the information, including costs associated with the electronic retrieval of records;

(C) Reporting in conformance with the appropriate format and standards, including costs associated with the retrieval of paper or electronic records;

(D) Computer programming necessary for reporting services;

(E) Consultation with the health care facility on reporting in conformance with the appropriate format and standards;

(b) Staff time will be calculated based on but not limited to hourly rate of pay, fringe benefits, office costs, insurance and information technology support for the position of the person performing the work.

(2) The Authority shall notify the health care facility of the estimated costs for providing cancer case reporting services.

Statutory/Other Authority: ORS 432.520
Statutes/Other Implemented: ORS 432.500 - 432.990
History:
PH 20-2017, amend filed 12/21/2017, effective 01/01/2018
OHD 11-1999, f. & cert. ef. 12-8-99

333-010-0100
ScreenWise Breast and Cervical Cancer Program: Description of the ScreenWise Breast and Cervical Cancer Program

The mission of the Oregon ScreenWise Program is to reduce breast cancer, cervical cancer, cardiovascular disease and other diseases by promoting early detection through screening, risk reduction counseling, behavior modification support, and referral to medical treatment. ScreenWise includes the Breast and Cervical Cancer Program (ScreenWise BCC), a federal screening and early detection program administered by the Oregon Health Authority to provide screening and diagnostic services to eligible Oregonians statewide. ScreenWise BCC provides coverage for screening and diagnostic services to Oregonians with family incomes up to 250 percent of the Federal Poverty Level through a contract network of qualified providers. OAR 333-010-0100 through 333-010-0197 apply only to providers who have an approved medical services agreement to provide screening and diagnostic services through this program. The program is limited to a finite source of funds which may restrict availability of services on an annual basis.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 28-2014, f. & cert. ef. 10-10-14
PH 1-2012, f. & cert. ef. 1-17-12
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0105
Definitions

(1) "Agency number" means the administrative number assigned to the service provider by the Center for Prevention and Health Promotion (Center) for identification as a ScreenWise Breast and Cervical Cancer services (ScreenWise BCC) provider.

(2) "Ancillary provider" means a provider that performs services beyond the scope of an enrolling provider. Ancillary providers may include but is not limited to laboratories, imaging centers, surgeons and surgical facilities, and hospitals.

(3) "Approved medical services agreement" means the completed ScreenWise BCC agreement, submitted to and approved by the Center for Prevention and Health Promotion.

(4) "Authority" means the Oregon Health Authority.

(5) "BCCTP" means the Breast and Cervical Cancer Treatment Program. ORS 414.534, 414.536.

(6) "Care coordination or case management" means that a client is provided with services, results, follow-up recommendations, and active tracking of progress towards follow-up recommendations.

(7) "Center" means the Center for Prevention and Health Promotion, the office within the Oregon Health Authority that administers the ScreenWise BCC.

(8) "CLIA" means the federal Clinical Laboratory Improvement Amendments of 1988, establishes quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results, and allows for certification of clinical laboratories operating in accordance with these federal amendments.

(9) "Client" means a person of any age or gender who is enrolled in and receives screening or diagnostic services from the ScreenWise BCC.

(10) "Enrolling provider" means a provider that enrolls a client into the ScreenWise BCC, provides care coordination for the client and timely data submission to ScreenWise BCC.

(11) "FPL" means the federal poverty level guidelines established each year by the Department of Health and Human Services, used to determine eligibility for ScreenWise BCC and other federally funded programs.

(12) "HIPAA" means the Health Insurance Portability and Accountability Act.

(13) "ScreenWise BCC" means the ScreenWise program component that provides statewide breast and cervical cancer screening and diagnostic services to eligible clients, that is administered by the Center for Prevention and Health Promotion within the Oregon Health Authority.

(14) "ScreenWise BCC Provider Network" means the combination of all contracted ScreenWise providers, including enrolling and ancillary providers.

(15) "Service provider" or "provider" means a licensed health care provider operating within a scope of practice, who is authorized by the Center to bill for breast and cervical cancer screening and diagnostic services for eligible clients.

(16) "Site number" means the administrative number assigned to the provider by the Center for identification of the geographic location of each ScreenWise BCC provider.

(17) "Underinsured" means that health insurance does not fully cover breast and cervical cancer screening services or that out-of-pocket cost sharing for diagnostic services would pose a financial hardship.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 28-2014, f. & cert. ef. 10-10-14
PH 13-2014(Temp), f. & cert. ef. 4-22-14 thru 10-19-14
PH 1-2012, f. & cert. ef. 1-17-12
PH 11-2011, f. & cert. ef. 10-27-11
PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0110
Client Eligibility

In order to be eligible for the ScreenWise BCC a client must meet the following eligibility criteria:

(1) Have an income based on family size that is at or below 250 percent of the Federal Poverty Level at the time of enrollment; and

(2) Reside or declare an intent to reside in Oregon; and

(3) Have no health insurance or be underinsured; and

(4) Meet one of the following criteria:

(a) Be a woman age 21 or over for clinically recommended breast and cervical cancer screening and diagnostic services; or

(b) Be a man of any age who is displaying signs or symptoms that may indicate breast cancer.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 1-2012, f. & cert. ef. 1-17-12
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0115
Client Enrollment

(1)(a) Clients are determined eligible on a self-declared basis, when they submit a completed and signed ScreenWise BCC enrollment form at the clinic site at the time of service.

(b) Prior to enrolling a client in ScreenWise BCC, providers with access to the Medicaid Management Information System (MMIS) shall check MMIS to verify that applicant is not currently receiving Medicaid. Clients enrolled in Medicaid are ineligible for ScreenWise BCC.

(2) Eligibility is effective for one year unless a client justifiably needs to begin a second breast or cervical cycle, as defined in the program manual, before the end of one year. Justifications include:

(a) The presence of new signs or symptoms; or

(b) The necessity of short-term follow-up, as defined in the program manual.

(3) If breast or cervical services are justifiably initiated again before the end of one year, then eligibility will automatically extend through the end of that cycle, even if the cycle lasts into a new year.

(4) ScreenWise BCC providers must keep a signed enrollment form on file at the clinic for a minimum of four years. Clients enrolled into the program who are found ineligible will be disenrolled.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 28-2014, f. & cert. ef. 10-10-14
PH 1-2012, f. & cert. ef. 1-17-12
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0120
Covered Services

(1) ScreenWise BCC covers screening and diagnostic services specific to breast and cervical cancer. Contracted providers will only be reimbursed for services related to breast and cervical cancer screening and diagnosis.

(2) Screening and diagnostic services include, but are not limited to:

(a) For breast cancer, both a clinical breast examination and a mammogram;

(b) For cervical cancer, both a pelvic examination and a Pap smear; and

(c) Laboratory tests and medical procedures necessary for detection and diagnosis of breast and cervical cancer.

(3) Information regarding covered services and CPT code lists, including required notice to providers regarding revisions, may be found in the provider’s Medical Services Agreement.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0125
Excluded Services

(1) Services and laboratory tests not directly related to breast and cervical cancer screening and diagnosis are not covered by ScreenWise BCC for any eligible client. If the client accepts financial responsibility for a non-covered service that is received during a visit, payment arrangements are between the provider and the client, per OAR 333-010-0140(5)(a).

(2) No payment will be made for any expense incurred for any of the following services or items:

(a) Treatment for cancer or pre-cancerous conditions; or

(b) Any medical service or laboratory tests whose primary purpose is for a reason other than breast or cervical cancer screening or diagnostic testing.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0130
Standards of Care for Breast and Cervical Cancer Screening and Diagnostic Services

Participating ScreenWise BCC providers must agree to provide screening and diagnostic services according to the following standards:

(1) Informed Consent. The client’s decision to participate in and consent to receive breast and cervical cancer screening and diagnostic services must be voluntary and without bias or coercion.

(a) The informed consent process, provided verbally and supplemented with written materials, must be presented in a language the client understands.

(b) Consent must be obtained from the individual client receiving screening and diagnostic services.

(2) Confidentiality. Services must be provided in a manner that respects the privacy and dignity of the individual.

(a) Providers must inform clients that services and medical records will be kept confidential.

(b) Records cannot be released without written client consent, except as required by law, or otherwise permitted by the Health Insurance Portability and Accountability Act (HIPAA).

(3) Linguistic and Cultural Competence. All services, support and other assistance must be provided in a manner that is responsive to the beliefs, interpersonal styles, attitudes, language, and behaviors of the individuals who are receiving services, and in a manner that has the greatest likelihood of ensuring their maximum participation in the program.

(a) All persons providing interpretation services must adhere to confidentiality guidelines.

(b) The provider must make interpretation services available to all clients needing or requesting such assistance at no cost to the client. The provider must notify clients in need of interpretation services of the availability of such services in accordance with the Civil Rights Act of 1964.

(c) The provider must assure the competency of language assistance provided to limited English proficiency clients by interpreters and bilingual staff. Family and friends should not be used to provide interpretation services, unless requested by the client.

(d) Provider shall make available easily understood client related materials and post signage in the languages of groups commonly encountered in the service area.

(e) All print, electronic, and audiovisual materials must be appropriate according to the client’s language and literacy. Providers must accommodate a client’s request for alternate formats.

(4) Access to Care. Services covered by ScreenWise BCC must be provided without cost to eligible clients. Providers must inform clients of the scope of services available through the program.

(a) Although not covered by ScreenWise BCC, treatment and supplies for pre-cancerous, cancerous conditions, and sexually transmitted infections must be available at the site, or by referral.

(b) Clients in need of additional medical services beyond the scope of the ScreenWise BCC provider network must be provided with information about available local resources.

(c) Clients with a qualifying breast or cervical cancer diagnosis, including specific pre-cancerous conditions, shall be screened to determine presumptive eligibility for the BCCTP and enrolling providers shall facilitate the application process.

(d) All services must be offered to eligible clients without regard to marital status, race, parity, disability, or sexual orientation.

(5) Clinical and Preventive Services. The scope of breast and cervical cancer screening and diagnostic services offered to clients must include:

(a) A health history, including health risk facts and personal and family medical history as it pertains to breast and cervical cancer screening.

(b) An initial physical examination that includes a breast and pelvic exam with a Pap smear.

(c) Follow-up recommendations.

(d) Care coordination to ensure that appropriate follow-up screening, diagnostic testing and care is provided, including:

(A) An explanation of the results of the physical examination and the laboratory tests; and

(B) The opportunity for questions concerning procedures, methods and results.

Statutory/Other Authority: ORS 413.042 & 414.540
Statutes/Other Implemented: ORS 413.042, 414.534 & 414.536
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 1-2012, f. & cert. ef. 1-17-12
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0135
Provider Enrollment

(1) This rule applies only to providers participating in ScreenWise BCC through an approved provider agreement with the Center.

(2) An individual or organization must meet applicable licensing or regulatory requirements set forth by federal and state statutes, regulations, and rules to be enrolled and to bill as a provider. In addition, all providers of services within the State of Oregon must have a valid Oregon business license if such a license is a requirement of the state, federal, county or city government to operate a business or to provide services.

(3) An individual or organization that is currently subject to sanctions by the Authority or the federal government is not eligible for enrollment.

(4) A ScreenWise BCC agency number will be issued to an individual or clinic upon:

(a) Completion of the application and submission of the required documents;

(b) The signing of the provider agreement by the provider or person authorized by the provider to bind the organization or individual to comply with these rules;

(c) Verification of licensing or certification; and

(d) Approval of the application by the Center.

(5) Issuance of an agency number establishes enrollment of an individual or organization as a provider for ScreenWise BCC services.

(6) If a provider changes address, business affiliation, licensure, ownership, certification, billing agents, registered name, or Federal Tax Identification Number (TIN), the Center must be notified in writing within 30 days of the change. Failure to notify the Center of a change of TIN may result in the imposing of a fine. Changes in business affiliation, ownership, registered name, and TIN may require the submission of a new application. Payments made to providers who have not furnished such notification may be recovered.

(7) Providers of services outside the state of Oregon will be enrolled under the following conditions:

(a) The provider is appropriately licensed or certified by the provider’s state;

(b) The provider lives in a state contiguous to Oregon, and is within seventy-five miles of the Oregon border.

(8) Provider termination:

(a) The provider may terminate enrollment at any time. The request must be sent to the Center in writing, via certified mail, return receipt requested. The notice shall specify the agency number to be terminated and the effective date of termination. Termination of the provider enrollment does not terminate any obligations of the provider for dates of services during which the enrollment was in effect.

(b) ScreenWise BCC provider terminations or suspensions and subsequent recovery of any payments made by the Center may be for, but are not limited to, the following reasons:

(A) Breaches of the medical services agreement;

(B) Failure to comply with the statutes, regulations and policies of the Authority, and federal or state regulations that are applicable to the provider;

(C) Loss of the appropriate licensure or certification.

(9) The provider is entitled to a contested case hearing to determine whether the provider’s agency number will be revoked.

(10) In the event of bankruptcy proceedings, the provider must notify the Center in writing within 15 days.

(11) Providers must receive information about administering the ScreenWise BCC from a ScreenWise BCC representative before services are initiated.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0140
Billing

(1) Only clinics providing breast and cervical cancer screening and diagnostic services pursuant to an approved medical services agreement, and who have been assigned an agency number may submit claims for ScreenWise BCC services.

(2) All services must be billed by submitting claim information in the method specified by the ScreenWise BCC.

(3) A primary diagnosis code is required on all claims. All billings must be coded with the most current and appropriate International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM), incorporated by reference and the most appropriate Current Procedural Terminology (CPT) codes. Information regarding CPT code lists, including required notice to providers regarding CPT code list revisions, may be found in the provider’s Medical Services Agreement. Claims including primary diagnosis codes that are not listed on the approved CPT code list will not be paid without program approval.

(4) The provider must use CLIA certified laboratories for all tests whether done at the clinic site or by an outside clinic.

(5) Enrolled providers with ScreenWise BCC must not seek payment from an eligible client, or from a financially responsible relative or representative of that individual, for any services covered by ScreenWise BCC.

(a) A client may be billed for services that are not covered by ScreenWise BCC. However, the provider must inform the client in advance of receiving the specific service that it is not covered, the estimated cost of the service, and that the client or client’s representative is financially responsible for payment for the specific service. Providers must document in writing that the client was provided this information and the client knowingly and voluntarily agreed to be responsible for payment. The client or client’s representative must sign the documentation.

(b) Services not covered by ScreenWise BCC are those outside of the scope of standard breast and cervical cancer screening and diagnosis, or those not included in the ICD-10 list, incorporated by reference and approved CPT code lists.

(6) Prior to submission of a claim to the Center for payment, an approved provider agreement must be in place.

(7) All claims must be submitted with data, as described in the claims section of the rules.

(a) Except for services performed by a CLIA certified laboratory outside of the clinic, all billings must be for services provided within the provider’s licensure or certification.

(b) Providers must submit true and accurate information when billing the Center.

(c) A claim may not be submitted prior to providing services.

(8) Diagnosis Code Requirement:

(a) A primary diagnosis code is required on all claims.

(b) Use the highest degree of specificity within the diagnosis codes listed in the ICD-10-CM codes, incorporated by reference, for breast and cervical screening or diagnostic testing.

(9) No provider shall submit to the Center:

(a) Any false claim for payment;

(b) Any claim altered in such a way as to result in a payment for a service that has already been paid;

(c) Any claim upon which payment has been made by another source unless the amount paid is clearly entered on the claim form;

(10) The provider must submit a billing error edit correction, or refund the amount of the overpayment, on any claim where the provider identifies an overpayment made by the Center.

(11) A provider who, after having been previously warned in writing by the Authority or the Department of Justice about improper billing practices, is found to have continued such improper billing practices and has had an opportunity for a contested case hearing, shall be liable to the Center for up to triple the amount of the established overpayment received as a result of such violation.

(12) Third Party Resources:

(a) Providers must make all reasonable efforts to ensure that ScreenWise BCC will be the payor of last resort with the exception of clinic or offices operated by the Indian Health Service (IHS) or individual American Indian tribes;

(b) Providers must make all reasonable efforts to obtain payment first from other resources. For the purposes of this rule reasonable efforts include:

(A) Determining the existence of insurance coverage or other resource by asking the client;

(B) Except in the case of the underinsured, when third party coverage is known to the provider, by any other means available:

(i) The provider must bill the third party resource;

(ii) Comply with the insurer’s billing and authorization requirements.

(C) Providers are required to submit a billing error edit correction showing the amount of the third party payment or to refund the amount received from another source within 30 days of the date the payment is received. Failure to submit a billing error edit correction within 30 days of receipt of the third party payment or to refund the appropriate amount within this time frame is considered concealment of material facts and grounds for recovery or sanction.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 17-2015, f. 9-30-15, cert. ef. 10-1-15
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0145
Claims and Data Submission

(1) In addition to submitting standard claims information, enrolling providers are required to submit client data in order to receive payment for the claim. The data is used to collect information pertaining to breast and cervical cancer prevention, diagnosis, and treatment and is used by the National Breast and Cervical Cancer Early Detection Program and the ScreenWise BCC primarily to monitor the delivery of services and clinical outcomes of the program.

(2) Although data requirements may require more information than necessary for payment of a specific claim, all related fields must be completed and submitted.

(3) Data requirements for enrolling providers and ancillary providers are as follows:

(a) Enrolling providers must provide required information on client data forms, as defined by the program and posted on the Program website: www.healthoregon.org/screenwise.

(b) Ancillary providers must provide results of services to enrolling providers. Ancillary providers are not required to provide data to the ScreenWise BCC directly.

(4) If a provider terminates the medical services agreement all data must be submitted through the completion of each client’s cycle.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0150
Timely Submission of Claims and Data

(1) All claims for services must be submitted within 120 days of the date of service. Claims older than 120 days from the date of service will not be paid, except as provided for in section (2) and (3) of this rule.

(2) If a claim is denied, the claim must be resolved within 120 days of the date of the denial. Claims older than 120 days from the date of denial will not be paid, except as provided for in section (3) of this rule.

(3) When the Center has made an error that caused the provider not to be able to bill within 120 days of the date of service, then the claim may be submitted to the Center. The error must be confirmed by the Center.

(4) Client data not related to payment of the claim may be updated or corrected at any time after the date of service.

(5) Ancillary providers must provide results of services to enrolling providers within 14 calendar days from the date of service.

(6) Enrolling providers must provide the ScreenWise BCC with enrollment and eligibility information immediately or within five calendar days from the date of enrollment. All other data must be submitted within 90 days from the date of enrollment. In the event that a case requires additional diagnostic procedures that exceed 90 days from the date of enrollment, the data must be submitted immediately upon receipt.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 28-2014, f. & cert. ef. 10-10-14
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0155
Payment

(1) The Center will make payment only to providers that have a medical services agreement with the ScreenWise BCC and are billing for an eligible client.

(2) The ScreenWise BCC reimbursement amount will be up to the Medicare reimbursement rate for the Portland metropolitan area for ScreenWise BCC approved CPT codes, on a fee-for-service basis.

(3) Federally qualified health centers or rural health centers are not paid at their Prospective Payment System (PPS) rate; they will receive up to the Medicare reimbursement rate for ScreenWise BCC approved CPT codes, on a fee-for-service basis.

(4) Center payments for ScreenWise BCC provider services, unless in error, constitute payment in full.

(5) The Center will not make payment on claims that have been assigned, sold, or otherwise transferred, or on which a provider of billing services receives a percentage of the amount billed or payment authorized. This includes, but is not limited to, transfer to a collection agency or individual who advances money to a provider for accounts receivable.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 28-2014, f. & cert. ef. 10-10-14
PH 13-2014(Temp), f. & cert. ef. 4-22-14 thru 10-19-14
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0160
Requirements for Financial, Clinical and Other Records

(1) The Center is responsible for analyzing and monitoring the operation of ScreenWise BCC and for auditing and verifying the accuracy and appropriateness of payment, utilization of services, the quality of care, and access to care. The provider shall:

(a) Develop and maintain adequate financial and clinical records and other documentation which supports the services for which payment has been requested. Payment will be made only for services that are adequately documented.

(b) All medical records must document the service provided, primary diagnosis code for the services, the date on which the service was provided, and the individual who provided the services. Patient account and financial records must also include documentation of charges, identify other payment resources pursued, indicate the date and amount of all debit or credit billing actions, and support the appropriateness of the amount billed and paid. The records must be accurate and in sufficient detail to substantiate the data reported.

(2) Clinical records must sufficiently document that the client’s services were primarily for breast or cervical cancer screening or diagnosis of breast or cervical cancer. The client’s record must be annotated each time a service is provided and signed or initialed by the individual who provided the service or must clearly indicate the individual who provided the service. Information contained in the record must meet the standards of care for breast and cervical cancer screening and diagnosis, and must be appropriate in quality and quantity to meet the professional standards applicable to the provider or practitioner and any additional standards for documentation set forth in this rule.

(3) The provider must have policies and procedures to ensure the maintenance of the confidentiality of medical record information. These procedures ensure that the provider may release such information in accordance with federal and state statutes, ORS 179.505, 411.320, 45 CFR 205.50.

(4) The provider must retain clinical, financial and other records described in this rule for at least four years from the date of last activity.

(5) Upon written request from the Center, the Authority, the Oregon Department of Justice Medicaid Fraud Unit, the Oregon Secretary of State, or their authorized representatives (Requestor), the provider must furnish requested documentation, without charge, immediately or within the time-frame specified in the written request. Copies of the documents may be furnished unless the originals are requested. At their discretion, representatives of the Requestor may review and copy the original documentation in the provider’s place of business. Upon the written request of the provider, the Requestor may, at their sole discretion, modify or extend the time for provision of such records if, in the opinion of the Center, good cause for such extension is shown. Factors used in determining whether good cause exists include:

(a) Whether the written request was made in advance of the deadline for production;

(b) If the written request is made after the deadline for production, the amount of time elapsed since that deadline;

(c) The efforts already made to comply with the request;

(d) The reasons the deadline cannot be met;

(e) The degree of control that the provider had over its ability to produce the records prior to the deadline; and

(f) Other extenuating factors.

(6) Access to records, inclusive of medical charts and financial records, does not require authorization or release from the client if the purpose of such access is to:

(a) Perform billing review activities;

(b) Perform utilization review activities;

(c) Review quality, quantity and services provided;

(d) Facilitate payment authorization and related services;

(e) Investigate a client’s fair hearing request;

(f) Facilitate investigation by the Authority;

(g) Where review of records is necessary to the operation of the program.

(7) Failure to comply with requests for documents and within the specified time-frames means that the records subject to the request may be deemed by the Authority not to exist for purposes of verifying appropriateness of payment, medical appropriateness, the quality of care, and the access to care in an audit or overpayment determination, and accordingly subjects the provider to possible denial or recovery of payments made by the Authority, or to sanctions.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0165
Compliance with Federal and State Statutes

(1) Submission of a claim for medical services or supplies provided to a ScreenWise BCC client shall be deemed a representation by the medical provider to the Center of the medical provider’s compliance with the applicable sections of the federal and state statutes referenced in this rule:

(a) 45 CFR Part 84 which implements Title V, Section 504 of the Rehabilitation Act of 1973;

(b) Title II and Title III of the Americans with Disabilities Act of 1991;

(c) Title VI of the Civil Rights Act of 1964;

(d) 42 CFR Part 493 Laboratory Requirements and ORS chapter 438 (Clinical Laboratories).

(2) Providers are required to comply with HIPAA regarding the confidentiality of client records.

(3) CLIA requires all entities that perform even one laboratory test, including waived tests on, "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings" to meet certain federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0170
Denial or Recovery of Reimbursement Resulting from Review or Audit

(1) The Center’s staff, contractor or auditor may review a claim for assurance that the specific medical service was provided in accordance with the program’s policies and rules and the generally accepted standards of a provider’s scope of practice or specialty.

(2) Payment may be denied or subject to recovery if review or audit determines the service does not meet the program’s policies, rules or the Standards of Care for Breast and Cervical Cancer Screening and Diagnostic Services set forth in OAR 333-010-0130.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0175
Recovery of Overpayments to Providers Resulting from Review or Audit

(1) When the Center determines that an overpayment has been made to a provider, the amount of overpayment is subject to recovery:

(a) To determine the overpayment amount, the Center may use a statistically valid random sampling, with sufficient sample size allowing a confidence interval of 95 percent.

(b) After the Center determines an overpayment amount by the random sampling method set forth in section (1) of this rule, the provider may request a 100 percent audit of all billings submitted to the Center for breast and cervical cancer screening and diagnostic services provided during the period in question. If a 100 percent audit is requested:

(A) Payment and arrangement for a 100 percent audit is the responsibility of the provider requesting the audit; and

(B) The audit must be conducted by a certified public accountant that is knowledgeable about the Oregon Administrative Rules covering the payments in question, and must be conducted within 120 calendar days of the request to use such audit in lieu of the Center’s random sample.

(2) The amount of the review or audit overpayment to be recovered:

(a) Will be the entire amount determined or agreed to by the Center;

(b) Is not limited to amounts determined by criminal or civil proceedings; and

(c) Will include interest to be charged at allowable state rates.

(3) The Center will deliver to the provider by registered or certified mail or in person a request for repayment of the overpayment and the documentation to support the alleged amount.

(4) If the provider disagrees with the Center’s determination or the amount of overpayment the provider may appeal the decision by requesting a contested case hearing:

(a) A written request for hearing must be submitted to the Center by the provider within 30 calendar days of the date of the decision affecting the provider. The request must specify the areas of disagreement.

(b) Failure to request a hearing or administrative review in a timely manner constitutes acceptance by the provider of the amount of the overpayment.

(5) The overpayment is due and payable 30 calendar days from the date of the decision by the Center:

(a) An additional 30 day grace period may be granted the provider upon request to the Center;

(b) A request for a hearing does not change the date the repayment of the overpayment is due.

(6) The Center may extend the reimbursement period or accept an offer of repayment terms. Any change in reimbursement period or terms must be made in writing by the Center.

(7) If the provider refuses to reimburse the overpayment or does not adhere to an agreed upon payment schedule, the Center may:

(a) Recoup future provider payments up to the amount of the overpayment; or

(b) Pursue civil action to recover the overpayment.

(8) As the result of a hearing the amount of the overpayment may be reduced in part or in full.

(9) The Center may, at any time, change the amount of the overpayment upon receipt of additional information. Any changes will be verified in writing by the Center. Any monies paid to the Center that exceed an overpayment will be refunded to the provider.

(10) If a provider is terminated or sanctioned for any reason, the Center may pursue civil action to recover any amounts due and payable to ScreenWise BCC.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0180
Provider Sanctions

The following are conditions that may result in the imposition of a sanction on a provider.

(1) Basis for Sanction:

(a) Conviction of a provider of a felony or misdemeanor related to a crime or violation of Title XVIII, XIX, or XX of the Social Security Act or related state laws (or entered a plea of nolo contendere);

(b) Conviction of fraud related to any federal, state, or locally financed health care program;

(c) Conviction of interference with the investigation of health care fraud;

(d) Conviction of unlawfully manufacturing, distributing, prescribing, or dispensing a controlled substance;

(e) Failure to comply with the state and federal statutory requirements set forth in OAR 333-010-0165;

(f) By actions of any state licensing authority for reasons relating to the provider's professional competence, professional conduct, or financial integrity, the provider either:

(A) Had a health care license suspended or revoked, or has otherwise lost such license; or

(B) Surrendered the license while a formal disciplinary proceeding was pending before a licensing authority.

(g) Suspension or exclusion from participation in a federal or state health care program for reasons related to professional competence, professional performance, or other reason;

(h) Improper billing practices, including billing for excessive charges or visits;

(i) Failure to furnish services as required by law or contract with the Center, if the failure has adversely affected (or has a substantial likelihood of adversely affecting) the client;

(j) Failure to supply requested information on subcontractors and suppliers of goods or services;

(k) Failure to supply requested payment information;

(l) Failure to grant access to facilities or provide records upon request of the Center or a designated Requestor;

(m) Receiving payments for services provided to persons who were not eligible;

(n) Establishing multiple claims using procedure codes that overstate or misrepresent the level, amount or type of health care provided;

(o) Failure to develop, maintain, and retain in accordance with relevant rules and standards adequate clinical or other records that document the medical appropriateness, nature, and extent of the health care provided;

(p) Failure to develop, maintain, and retain in accordance with relevant rules and standards adequate financial records that document charges incurred by a client and payments received from any source;

(q) Failure to follow generally accepted accounting principles or accounting standards or cost principles required by federal or state laws, rule, or regulation;

(r) Submission of claims or written orders contrary to generally accepted standards of medical practice;

(s) Submission of claims for services that exceed that requested or agreed to by the client or the responsible relative or guardian or requested by another medical practitioner;

(t) Breach of the terms of the medical services agreement;

(u) Failure to correct deficiencies in operations after receiving written notice of the deficiencies from the Center;

(v) Submission of any claim for payment for which payment has already been made by the Center; or

(w) Provision of or billing for services provided by ineligible or unsupervised staff.

(2) A provider who has been suspended or terminated from participation in a federal or state medical program, such as Medicare or Medicaid, or whose license to practice has been suspended or revoked by a state licensing board, shall not submit claims for payment, either personally or through claims submitted by any billing provider or other provider, for any services or supplies provided under ScreenWise BCC, except those services provided prior to the date of suspension or termination.

(3) When the provisions of section (2) of this section are violated, the Center may suspend or terminate the provider who is responsible for the violation.

(4) Provider sanctions will be imposed at the discretion of the Authority or the administrator of the office whose budget includes payment for the services involved.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0185
Provider Appeals

A provider may appeal certain decisions affecting the provider made by the Center. There are two levels of appeal. Level 1 is a reconsideration on a claim. Level 2 is a contested case hearing.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0190
Provider Appeals (Level 1) — Claims Reconsideration

A provider disputing the Center’s claim decision may request reconsideration. The provider must submit the request in writing to the Center. The request must include the reason for the dispute, and any information pertinent to the outcome of the dispute. The Center will complete an additional review and respond back to the provider in writing. If the provider is not satisfied with the review, the provider may request a contested case hearing.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0195
Provider Appeals (Level 2) — Contested Case Hearing

Contested case hearings will be held in accordance with ORS 183.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042
History:
PH 9-2008, f. & cert. ef. 6-16-08

333-010-0197
Presumptive Eligibility for BCCTP

(1) Any licensed health care provider who can diagnose breast or cervical cancer may presumptively enroll a client into BCCTP and refer the client to the Oregon Health Plan if she meets the presumptive eligibility criteria as described in section (2) of this rule.

(2) In order to be presumptively enrolled into BCCTP a client must meet the eligibility criteria in OAR 333-010-0110 and 410-200-0400.

Statutory/Other Authority: ORS 413.042 & 414.540
Statutes/Other Implemented: ORS 414.534 & 414.536
History:
PH 11-2016, f. & cert. ef. 4-1-16
PH 20-2015(Temp), f. & cert. ef. 10-12-15 thru 4-8-16
PH 1-2012, f. & cert. ef. 1-17-12

333-010-0200
ScreenWise WISEWOMAN Program: Description of the WISEWOMAN Program

The WISEWOMAN (WW) Program is a federal program, administered by the Oregon Health Authority, that provides heart disease, stroke and diabetes screening support to develop and maintain healthy behaviors, and referral services in an effort to prevent cardiovascular disease to eligible women statewide. The WW Program provides these services through a contract network of qualified providers. These rules (OAR 333-010-0200 through 333-010-0290) apply only to providers who have an approved medical services agreement to provide screening and services through this program. The program is limited to a finite source of funds, which may restrict availability of services on an annual basis.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0205
Definitions

(1) "Agency number" means the administrative number assigned to the service provider by the Center for Prevention and Health Promotion (Center) for identification as a BCCP/WW provider.

(2) "Ancillary provider" means an individual or entity that has met the eligibility requirements for enrollment in the WW Program, has executed a medical services agreement with the Center, has been assigned a BCCP/WW Program agency number, and performs services beyond the scope of an enrolling provider, such as laboratory, imaging, or surgical services.

(3) "Approved medical services agreement" means the completed WW Program agreement, submitted to and approved by the Center for Prevention and Health Promotion.

(4) "Authority" means the Oregon Health Authority.

(5) "BCCP" means the Oregon Breast and Cervical Cancer Program.

(6) "Care coordination" or "case management" means that a client is provided with services, results, follow-up recommendations, and active tracking of progress towards follow-up recommendations.

(7) "Center" means the Center for Prevention and Health Promotion, within the Oregon Health Authority, Public Health Division.

(8) "CLIA" means the federal Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578, 42 U.S.C. 201 and 263a)

(9) "Client" means a woman 40 to 64 years of age who is enrolled in and receives screening or services from the WW Program.

(10) "Enrolling provider" means an individual or entity that has met the eligibility requirements for enrollment in the WW Program, has executed a medical services agreement with the Center, has been assigned a BCCP/WW Program agency number, and provides screening, services, or care coordination for WW Program clients.

(11) "FPL" means the federal poverty level guidelines established each year by the United States Department of Health and Human Services, used to determine eligibility for the WW Program and other federally funded programs.

(12) "HIPAA" means the Health Insurance Portability and Accountability Act.

(13) "Site number" means the administrative number assigned to the family planning service provider by the Center for identification of the geographic location of each WW provider.

(14) "WISEWOMAN Program" or "WW Program" means the program that provides statewide heart disease, stroke and diabetes screening and services to eligible clients, that is administered by the Center.

(15) "WW Program provider network" means the combination of all contracted WW Program providers, including enrolling and ancillary providers.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 11-2011, f. & cert. ef. 10-27-11
PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0210
Client Eligibility

A person must meet the following WW Program eligibility criteria in order to be enrolled in the WW Program:

(1) Be a woman 40 to 64 years of age; and

(2) Be enrolled in the BCCP program.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0215
Client Enrollment

(1) A person is determined eligible for the WW Program after submitting a completed and signed BCCP/WW Program enrollment form.

(2) Eligibility is effective for one year.

(3) A person who enrolled in the WW Program but who is later found to be ineligible shall be notified by the Center or her enrolling provider in writing of such disenrollment and may be responsible for the payment of services received from her provider.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0220
Provider Enrollment

(1) An individual or organization that wishes to be an enrolling provider or an ancillary provider with the WW Program shall apply to the Center on a form prescribed by the Center.

(2) In order to be eligible for enrollment, an individual or organization shall:

(a) Have a valid Oregon business license if such a license is a requirement of the state, federal, county or city government to operate a business or to provide services; and

(b) Meet applicable licensing or regulatory requirements set forth by federal and state statutes, regulations, and rules to be enrolled and to bill as a health care provider.

(3) A laboratory or any other entity that does laboratory tests must provide evidence that it is CLIA certified in order to be a provider or an ancillary provider.

(4) An individual or organization that is currently subject to sanctions by the Authority or the federal government is not eligible for enrollment.

(5) Upon receipt of an application the Center shall verify the information and determine if the individual or organization is eligible to be an enrolling or ancillary provider.

(6) If the Center approves an application, an individual or organization shall:

(a) Sign a medical services agreement that requires the provider to comply with these rules; and

(b) Be issued a BCCP/WW Program agency number.

(7) An enrolling or ancillary provider may not offer services to a client prior to receiving information from a Center WW Program representative about administering the WW Program.

(8) An enrolling provider or ancillary provider shall notify the Center in writing within 30 days of the change if it changes its address, business affiliation, licensure, ownership, certification, billing agents, registered name, or Federal Tax Identification Number (TIN). Changes in business affiliation, ownership, registered name, and TIN may require the submission of a new application. Payments made to an enrolling provider or an ancillary provider who has not furnished such notification may be recovered by the Center.

(9) An enrolling provider or an ancillary provider shall notify the Center in writing of a bankruptcy proceedings within 15 days.

(10) An individual or organization outside the state of Oregon may be eligible for enrollment if the individual or organization:

(a) Is appropriately licensed or certified in its state; and

(b) Is located in a state contiguous to Oregon, and is within 75 miles of the Oregon border.

(11) An enrolling provider or an ancillary provider may terminate enrollment at any time by sending a written termination notice to the Center, via certified mail, return receipt requested. The notice shall specify the agency number to be terminated and the effective date of termination. Termination of a provider enrollment does not terminate any obligations of the provider for services provided to a client prior to the effective date of the termination.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0225
Standards of Care for WISEWOMAN Program Screening and Services

An enrolling provider shall:

(1) Inform each client, verbally and with supplementary written materials in a language the client understands, without bias or coercion, that the client’s decision to participate in the WW Program screening and services is voluntary;

(2) Inform clients of the scope of services available through the program;

(3) Obtain informed consent from each client receiving WW screening and services;

(4) Provide services within the scope by the WW Program without cost to eligible clients;

(5) Offer clients with abnormal or ALERT values additional medical support even though treatment is not covered by the WW Program. The WW Program Manual, October 2014, incorporated by reference, includes a complete list of abnormal and ALERT values and medical support services approved for reimbursement.

(6) Provide information to clients in need of additional medical services beyond the scope of the WW Program provider network with information about available local resources;

(7) Provide all services to eligible clients without regard to marital status, race, parity, disability, or sexual orientation;

(8) Take a health history for all clients, including health risk facts and personal and family medical history as it pertains to heart disease, stroke and diabetes screening;

(9) Provide follow-up recommendations for each client;

(10) Provide care coordination to ensure that appropriate follow-up screening, diagnostic testing and care is provided, including:

(a) An explanation of the results of the screening and laboratory tests; and

(b) The opportunity for questions concerning procedures, methods and results.

(11) Submit enrollment and eligibility information immediately or within five calendar days from the date of enrollment to the Center;

(12) Submit all client data to the WW Program, including required information about client history and screening results;

(13) Provide services to each client in a manner that respects the privacy and dignity of the individual;

(14) Inform clients that services and medical records will be kept confidential and that records cannot be released without written client consent, except as required by law, or otherwise permitted by HIPAA;

(15) Provide all services, support and other assistance in a manner that is responsive to the beliefs, interpersonal styles, attitudes, language, and behaviors of the clients receiving services, and in a manner that has the greatest likelihood of ensuring a client’s maximum participation in the program;

(16) Notify clients of the availability of interpretation services in accordance with the Civil Rights Act of 1964, and make interpretation services available to all clients needing or requesting such assistance at no cost to the client;

(a) A provider shall ensure that all persons providing interpretation services adhere to confidentiality guidelines;

(b) A provider must assure the competency of language assistance provided to clients by interpreters and bilingual staff. Family and friends should not be used to provide interpretation services, unless requested by the client;

(17) Make available easily understood client related materials and post signage in the languages of groups commonly encountered in the service area;

(18) Ensure that all print, electronic, and audiovisual materials are appropriate according to the client’s language and literacy level, including accommodating a client’s request for alternate formats; and

(19) Use only CLIA certified laboratories for all tests, whether done at the clinic site or by an outside clinic.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0230
Submission of Information by Ancillary Providers

Ancillary providers shall provide results of services to enrolled providers within 14 calendar days from the date of service.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.150
History:
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0235
Covered Services

The WW Program Manual, October 2014, incorporated by reference, includes a complete list of covered services.

[Publications: Publications referenced are available from the Oregon WW Program].

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0240
Excluded Services

(1) Services and laboratory tests not directly related to heart disease, stroke and diabetes, or not included in the ICD-10 and CPT code lists provided in the WW Program Manual are not covered by the WW Program.

(2) No payment will be made for any expense incurred for any other medical service or laboratory tests whose primary purpose is for a reason other than heart disease, stroke, or diabetes screening and prevention.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 17-2015, f. 9-30-15, cert. ef. 10-1-15
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0245
Claims and Billing

(1) Only an enrolling or ancillary provider providing WW Program covered services pursuant to a fully executed medical services agreement, and who has been assigned an agency number may submit claims for payment to the Center for providing WW Program covered services.

(2) An enrolling or ancillary provider shall, as applicable:

(a) Submit claim information in the manner specified by the WW Program;

(b) Include a primary diagnosis code on all claims;

(c) Code all claims with the most current and appropriate International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis codes and the most appropriate Current Procedural Terminology (CPT) codes as noted in the WW Program Manual;

(d) Submit to the Center all claims for services within 12 months of the date of service;

(e) Submit a billing error edit correction, or refund the amount of the overpayment, on any claim where a provider identifies an overpayment made by the Center;

(f) Make all reasonable efforts to ensure that the WW Program is the payor of last resort with the exception of clinics or offices operated by the Indian Health Service (IHS) or individual American Indian tribes. For the purposes of this rule "reasonable efforts" include:

(A) Determining the existence of insurance coverage or other resource by asking the client; and

(B) Except in the case of the underinsured, billing any known insurer in compliance with that insurer’s billing and authorization requirements.

(g) Submit to the Center a billing error edit correction if it receives a third party payment and refund to the Center the amount received from the other source within 30 days of the date the payment is received.

(3) The Center may not pay a claim older than 12 months, except as provided for in section (4) of this rule. An enrolling or ancillary provider that has a claim rejected because of an error must resolve the error within 12 months of the date of service.

(4) If the Center makes an error that makes it impossible for an enrolling or ancillary provider to bill within 12 months of the date of service, the enrolling or ancillary provider shall notify the Center of the alleged error and submit the claim to the Center. The Center shall confirm that it made an error prior to payment being made.

(5) The Center may not pay a claim that includes a primary diagnosis code that is not in the WW Program Manual.

(6) An enrolling or ancillary provider with the WW Program may not seek payment from a client, or from a financially responsible relative or representative of that client for any services covered by the WW Program.

(7) An enrolling or ancillary provider may bill a client for services that are not covered by the WW Program. However, the provider must inform the client in advance of receiving the specific service that it is not covered, the estimated cost of the service, and that the client or client’s representative is financially responsible for payment for the specific service. Providers must document in writing that the client was provided this information and the client knowingly and voluntarily agreed to be responsible for payment. The client or client’s representative must sign the documentation.

(8) Except for services performed by a CLIA certified laboratory outside of the clinic, all billings by an enrolling provider must be for services provided within the provider’s licensure or certification.

(9) A provider who has been suspended or terminated from participation in a federal or state medical program, such as Medicare or Medicaid, or whose license to practice has been suspended or revoked by a state licensing board, may not submit claims for payment, either personally or through claims submitted by any billing provider or other provider, for any services or supplies provided under the WW Program, except those services provided prior to the date of suspension or termination.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 17-2015, f. 9-30-15, cert. ef. 10-1-15
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0250
Payment

(1) The Center shall only pay claims submitted by an enrolling or ancillary provider for a client.

(2) The Center shall reimburse an enrolling or ancillary provider an amount up to the Medicare reimbursement rate for the Portland metropolitan area for WW Program approved CPT codes, on a fee-for-service basis.

(3) A federally qualified health center or rural health center shall not be paid at their Prospective Payment System (PPS) rate, but will be paid at the reimbursement rate described in section (2) of this rule.

(4) The Center payments for WW Program provider services, unless in error, constitute payment in full.

(5) The Center may not make payment on claims that have been assigned, sold, or otherwise transferred, or on which a provider of billing services receives a percentage of the amount billed or payment authorized, including claims that have been transferred to a collection agency or individual who advances money to a provider for accounts receivable.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0255
Denial or Recovery of Reimbursement Resulting from Review or Audit

(1) The Center’s staff, contractor or auditor may review a claim for assurance that the specific medical service was provided in accordance with the WW Program’s rules or the generally accepted standards of a provider’s scope of practice or specialty.

(2) Payment may be denied or subject to recovery if a review or audit determines the service was not provided in accordance with the WW Program’s rules or the generally accepted standards of a provider’s scope of practice or specialty.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0260
Recovery of Overpayments to Providers Resulting from Review or Audit

(1) If the Center determines that an overpayment has been made to an enrolling or ancillary provider, the Center shall seek to recover the amount of overpayment. The Center may use a statistically valid random sampling, with sufficient sample size allowing a confidence interval of 95 percent to determine if an overpayment has been made.

(2) The amount of the review or audit overpayment to be recovered:

(a) Will be the entire amount determined by the Center;

(b) Is not limited to amounts determined by criminal or civil proceedings; and

(c) Will include interest to be charged at allowable state rates.

(3) The Center shall provide an enrolling provider in writing, by registered or certified mail or in person, notice of an overpayment and a request for repayment of the overpayment, along with documentation to support the amount owed.

(4) An enrolling or ancillary provider shall pay the overpayment amount within 30 calendar days from the date the Center mails the notice of overpayment. A request for a hearing does not change the date the repayment of the overpayment is due.

(5) The Center may extend the 30-day repayment period or accept an offer of repayment terms. Any change in reimbursement period or terms must be documented in writing by the Center.

(6) If the provider disagrees with the Center's determination or the amount of overpayment the provider may:

(a) Appeal the decision by requesting a contested case hearing; or

(b) Request a 100 percent audit of all billings submitted to the Center for heart disease, stroke, and diabetes screenings and services provided during the period in question.

(7) A written request for hearing must be submitted to the Center by the provider within 30 calendar days of the date of the decision affecting the provider. The request must specify the areas of disagreement. Failure to request a hearing or administrative review in a timely manner constitutes acceptance by the provider of the amount of the overpayment.

(8) If a 100 percent audit is requested:

(a) An enrolling or ancillary provider is responsible for arranging and paying for the audit; and

(b) The audit must be conducted by a certified public accountant that is knowledgeable about the Oregon Administrative Rules covering the payments in question, and must be conducted within 120 calendar days of the request to use such an audit in lieu of the Center's random sample.

(9) If the provider refuses to reimburse the overpayment or does not adhere to an agreed upon payment schedule, the Center may:

(a) Recoup future provider payments up to the amount of the overpayment; or

(b) Pursue civil action to recover the overpayment.

(10) The Center may, at any time, change the amount of the overpayment upon receipt of additional information from an enrolling provider. If the Center changes an overpayment amount it will provide written notice to the enrolling provider. Any monies paid to the Center that exceed an overpayment will be refunded to the provider.

(11) The Center may pursue civil action to recover any amounts due and payable to the WW Program.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0265
Client Data Submission

(1) In addition to submitting the claim information required in OAR 333-010-0225, in order to receive payment an enrolling provider shall submit client data to the Center. The data shall be used by the WW Program to monitor the delivery of services and clinical outcomes of the program.

(2) An enrolling provider shall submit client data to the Center, in a manner specified by the Center, on the Enrollment Form, Assessment Form and the Screening Form, included in the WW Program Manual within 90 days from the date of enrollment. In the event that a client requires additional diagnostic procedures and the information is not available within 90 days from the date of enrollment, the data shall be submitted to the Center immediately once it is received by the provider.

(3) An ancillary provider shall report data to an enrolling provider and is not required to provide data to the Center directly.

(4) An enrolling provider may update or correct client data not related to payment of the claim at any time after the date of service.

(5) If an enrolling provider or the Center terminates the medical services agreement, data are still required to be submitted for each client that was provided services while the agreement was in effect.

[Publications: Publications referenced are available from the agency]

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0270
Requirements for Financial, Clinical and Other Records

(1) An enrolling provider shall:

(a) Develop and maintain adequate financial and clinical records and other documentation that supports the services for which payment has been requested;

(b) Ensure that all medical records document the service provided, primary diagnosis code for the services, the date on which the service was provided, and the individual who provided the services;

(c) Ensure that patient account and financial records include documentation of charges, identify other payment resources pursued, indicate the date and amount of all debit or credit billing actions, and support the appropriateness of the amount billed and paid in accurate and sufficient detail to substantiate the data reported;

(d) Ensure that clinical records sufficiently document that the client’s services were primarily for heart disease, stroke and diabetes;

(e) Ensure that each time a service is provided to a client, the client’s record is signed or initialed by the individual who provided the service or otherwise clearly indicates who provided the service;

(f) Ensure that the information contained in the record reflects that the standard of care for heart disease, stroke and diabetes screening and services were met;

(g) Have policies and procedures to ensure the confidentiality of medical records and that address the circumstances under which information may be released in accordance with federal and state law; and

(h) Retain client enrollment forms, clinical, financial and other records described in this rule for at least four years from the date of last activity.

(2) The Center, the Authority, the Oregon Department of Justice Medicaid Fraud Unit, the Oregon Secretary of State, or their authorized representatives (requestor) may request, in writing, any records related to an enrolling or ancillary provider’s participation in the WW Program, including client medical records. An enrolling or ancillary provider shall furnish requested records, without charge, immediately or within the time frame specified in the written request. Copies of the documents may be furnished unless the originals are requested. At the requestor’s discretion, representatives of the requestor may review and copy the original documentation in the provider’s place of business. Upon the written request of the provider, the requestor may, at its sole discretion, modify or extend the time for provision of such records for good cause shown.

(3) Failure to comply with requests for documents within the specified time frames means that the records subject to the request may be deemed by the Authority not to exist for purposes of verifying appropriateness of payment, medical appropriateness, the quality of care, and the access to care in an audit or overpayment determination, and accordingly subjects the provider to possible denial or recovery of payments made by the Authority, or to sanctions.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0275
Compliance with Federal and State Statutes

(1) Submission of a claim for medical services or supplies provided to a client shall be deemed a representation by the enrolling or ancillary provider to the Center of the provider’s compliance with the applicable sections of the following federal and state statutes:

(a) 45 CFR Part 84 which implements Title V, Section 504 of the Rehabilitation Act of 1973;

(b) Title II and Title III of the Americans with Disabilities Act of 1991;

(c) Title VI of the Civil Rights Act of 1964; and

(d) 42 CFR Part 493 Laboratory Requirements and ORS Chapter 438 (Clinical Laboratories).

(2) Enrolling and ancillary providers are required to comply with HIPAA regarding the confidentiality of client records.

(3) A provider that performs even one laboratory test, including waived tests on "materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of human beings" is considered a laboratory under CLIA and therefore CLIA certification may be required.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0280
Provider Sanctions

(1) The Center may sanction an enrolling provider if the provider:

(a) Is convicted of a felony or misdemeanor related to a crime or violation of Title XVIII, XIX, or XX of the Social Security Act or related state laws (or entered a plea of nolo contendere);

(b) Is convicted of fraud related to any federal, state, or locally financed health care program;

(c) Is convicted of interference with the investigation of health care fraud;

(d) Is convicted of unlawfully manufacturing, distributing, prescribing, or dispensing a controlled substance;

(e) Fails to comply with the state and federal statutory requirements set forth in OAR 333-010-0275;

(f) By actions of any state licensing authority for reasons relating to the provider's professional competence, professional conduct, or financial integrity:

(A) Has a health care license suspended or revoked, or has otherwise lost such license; or

(B) Surrenders a health care license during a pending formal disciplinary proceeding;

(g) Is suspended or excluded from participation in a federal or state health care program for reasons related to professional competence, professional performance, or other reason;

(h) Engages in improper billing practices, including:

(A) Billing for excessive charges or visits;

(B) Submitting a false claim for payment;

(C) Altering a claim in such a way as to result in a payment for a service that has already been paid; or

(D) Making a claim upon which payment has been made by another source unless the amount paid is clearly entered on the claim form;

(i) Fails to furnish services as required by law or contract with the Center, if the failure has adversely affected (or has a substantial likelihood of adversely affecting) the client;

(j) Fails to supply requested information on subcontractors and suppliers of goods or services;

(k) Fails to supply requested payment information;

(l) Fails to grant access to facilities or provide records upon request of the Center or a designated requestor;

(m) Receives payments for services provided to persons who were not eligible;

(n) Establishes multiple claims using procedure codes that overstate or misrepresent the level, amount or type of health care provided;

(o) Fails to develop, maintain, and retain, in accordance with relevant rules and standards adequate clinical or other records that document the medical appropriateness, nature, and extent of the health care provided;

(p) Fails to develop, maintain, and retain, in accordance with relevant rules and standards, adequate financial records that document charges incurred by a client and payments received from any source;

(q) Fails to follow generally accepted accounting principles or accounting standards or cost principles required by federal or state laws, rules, or regulation;

(r) Submits claims for services provided that were contrary to generally accepted standards of medical practice;

(s) Submits claims for services that exceed that requested or agreed to by the client or the responsible relative or guardian or requested by another medical practitioner;

(t) Breaches the terms of the medical services agreement;

(u) Fails to correct deficiencies in operations after receiving written notice of the deficiencies from the Center;

(v) Fails to submit a billing error edit correction within 30 days of receipt of the third party payment or to refund the appropriate amount within this time frame;

(w) Provides or bills for services provided by ineligible or unsupervised staff;

(x) Submits claims for payment, either personally or through claims submitted by any billing provider or other provider, for any services or supplies provided under the WW Program for services provided after being suspended or terminated from participation in a federal or state medical program, such as Medicare or Medicaid, or after his or her license to practice has been suspended or revoked by a state licensing board;

(y) Fails to notify the Center of a change of TIN within 30 days; or

(z) Fails to respond to a request for records under OAR 333-010-0270.

(2) Sanctions may include:

(a) Termination from participation in the WW Program;

(b) Suspension from participation in the WW Program for a specified length of time, or until specified conditions for reinstatement are met and approved by the Center;

(c) Withholding payments to an enrolling or ancillary provider;

(d) A requirement to attend provider education sessions at the expense of the sanctioned enrolling or ancillary provider;

(e) A requirement that payment for certain services are made only after the Center has reviewed documentation supporting the services;

(f) The recovery of investigative and legal costs;

(g) Reduction of any amount otherwise due the enrolling or ancillary provider; and the reduction may be up to three times the amount a provider sought to collect from a client;

(h) Any other sanction reasonably designed to remedy or compel future compliances with federal, state or Center regulations.

(3) An enrolling or ancillary provider who has been the subject of repeat sanctions regarding improper billing practices may be liable to the Center for up to triple the amount of the established overpayment received as a result of such violation.

(4) When an enrolling or ancillary provider fails to meet one or more of the requirements identified in this rule the Center, at its sole discretion, may immediately suspend the provider's BCCP/WW Program assigned billing number to prevent public harm or inappropriate expenditure of public funds.

(a) An enrolling or ancillary provider subject to immediate suspension is entitled to a contested case hearing as outlined in OAR 333-010-0290 to determine whether the provider's BCCP/WW Program assigned number will be revoked.

(b) The notice requirements described in section (5) of this rule does not preclude immediate suspension at the Center's sole discretion to prevent public harm or inappropriate expenditure of public funds. Suspension may be invoked immediately while the notice and contested case hearing rights are exercised.

(5) If the Center decides to sanction an enrolling or ancillary provider, the Center shall notify the provider by certified mail or personal delivery service of the intent to sanction. The notice of immediate or proposed sanction will identify:

(a) The factual basis used to determine the alleged deficiencies;

(b) Explanation of actions expected of the provider;

(c) Explanation of subsequent actions the Center intends to take;

(d) The provider's right to dispute the Center’s allegations, and submit evidence to support the provider's position; and

(e) The provider's right to appeal the Center's proposed actions pursuant to OAR 333-010-0285 through 333-010-0290.

(6) If the Center makes a final decision to sanction an enrolling or ancillary provider, the Center shall notify the provider in writing at least 15 days before the effective date of action, except in the case of immediate suspension to avoid public harm or inappropriate expenditure of funds.

(7) An enrolling or ancillary provider must appeal an immediate or proposed sanction separately from any appeal of audit findings and overpayments.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0285
Provider Appeals (Level 1) — Claims Reconsideration

An enrolling or ancillary provider disputing a claim or sanction decision by the Center may request reconsideration. The provider must submit the request for reconsideration in writing to the Center. The request must include the reason for the dispute, and any information pertinent to the outcome of the dispute. The Center will complete an additional review and respond back to the provider in writing. If the provider is not satisfied with the review, the provider may request a contested case hearing.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0290
Provider Appeals (Level 2) — Contested Case Hearing

An enrolling or ancillary provider may request a contested case hearing within 30 calendar days of the date of a decision affecting the provider. Contested case hearings will be held in accordance with ORS Chapter 183 and the Attorney General’s model rules, OAR 137-003-0501 through 137-003-0700.

Statutory/Other Authority: ORS 413.042
Statutes/Other Implemented: ORS 413.042 & 431.250
History:
PH 27-2014, f. & cert. ef. 10-10-14
PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14
PH 1-2009, f. & cert. ef. 2-13-09

333-010-0300
Tobacco Prevention and Education Program: Definitions

(1) “Centers for Disease Control and Prevention” means the federal agency of the Department of Health and Human Services responsible for promoting health and quality of life through the prevention and control of disease, injury and disability.

(2) “Conference of Local Health Officials” means All local health officers and public health administrators, appointed pursuant to ORS 431.418 and such other local health personnel as may be included by the rules of the conference.

(3) “Contractor” means an independent contractor or corporation that performs a service(s) for an Agency, when an Agency has no right to and does not control the means and manner of performing the contract, except as to the delivery schedule, determining compliance with the Statement of Work, and accepting or rejecting the deliverables or results required under the contract.

(4) “Director” means the Assistant Director of the Oregon Public Health Division or his/her designee.

(5) “Environmental Tobacco Smoke” means the mixture of smoke from the burning end of a cigarette, pipe, or cigar, and the smoke exhaled from the lungs of smokers. It is also referred to as “second-hand smoke.”

(6) “Governor’s Tobacco Reduction Advisory Committee” has the meaning given that term in Executive Order 97-10.

(7) “Local Coalition” means an organization of individuals representing diverse groups, factions, or constituencies from a community who agree to work together to achieve the common goal of reducing tobacco use and its impact on the health and economic well-being of the community.

(8) “Local Health Department” means the county or district public health agency or the provider of public health services authorized by the county or district.

(9) “Local Lead Agency” means a local health department, local governmental, or not-for-profit health-related organization designated by a local health department within a county, that submits a proposal to the Oregon Public Health Division for a grant under the “Local Coalition and Community-Based Programs” section of these rules.

(10) “Proposal” means a written response submitted in application to the Oregon Public Health Division’s Tobacco Prevention and Education Program Request for Proposals.

(11) “Request for Proposals (RFP)” means a written document issued by the Public Health Division calling for proposals for services or activities to be performed by a grantee or contractor under the terms of these rules.

(12) “School district” means a taxing disctrict within the state that provides public elementary and secondary education K-12, or an education service district (ESD), or a state operated school, or any legally constituted combination of such entities.

(13) “Superintendent” means the State Superintendent of Public Instruction of the Department of Education or his or her designee.

(14) “Tobacco-Free Coalition of Oregon” (TOFCO) means the broad-based alliance of people and organizations that created the Oregon Statewide Tobacco Prevention Plan, and whose goal is to reduce tobacco use and decrease the human and economic costs of tobacco use among Oregonians.

Statutory/Other Authority: ORS 431.834
Statutes/Other Implemented: ORS 431.831 - 431.836
History:
HD 11-1997, f. & cert. ef. 9-12-97

333-010-0310
Tobacco Prevention and Education Program: Purpose and Intent

The purpose of this rule is to implement Chapter 2 of Oregon Laws of 1997, approved by the people as Ballot Measure 44, at the November 5, 1996 General Election, which:

(1) Authorizes 5.77% of the money received by the Department of Revenue under the Tobacco Products Tax Act to be credited to the Tobacco Use Reduction Account; and

(2) Requires the Public Health Division to adopt rules for awarding grants to programs for educating the public on the risk of tobacco use, including but not limited to, educating children on the health hazards and consequences of tobacco use, and promoting enrollment in smoking cessation programs.

Statutory/Other Authority: ORS 431.834
Statutes/Other Implemented: ORS 431.831 - 431.836
History:
HD 11-1997, f. & cert. ef. 9-12-97

333-010-0320
Tobacco Prevention and Education Program: Framework for Grant Awards

(1) These rules describe provisions for awarding grants and contracts for local, regional, and statewide activities in four program areas. The program areas are:

(a) Local Coalitions and Community-Based Programs;

(b) School-Based Prevention Programs;

(c) Statewide Public Awareness and Education Programs; and

(d) Statewide and Regional Special Programs.

(2) Proposals shall support the following goals of Oregon’s Statewide Tobacco Prevention Plan:

(a) Decrease tobacco use by youth;

(b) Treat tobacco dependence;

(c) Protect children from exposure to tobacco; and

(d) Protect workers and the public from second-hand smoke.

(3) Proposals must contain a statement disclosing any and all direct and indirect organizational or business relationships between the applicant or its subcontractors, including its owners, parent company or subsidiaries, and companies involved in any way in the production, processing, distribution, promotion, sale or use of tobacco.

Statutory/Other Authority: ORS 431.834
Statutes/Other Implemented: ORS 431.831 - 431.836
History:
HD 11-1997, f. & cert. ef. 9-12-97

333-010-0330
Tobacco Prevention and Education Program: Local Coalitions and Community-Based Programs

The goal of the Oregon Public Health Division under this section is to fulfill the purpose and intent of Chapter 2 of Oregon Laws of 1997, approved by the people as Ballot Measure 44, at the November 5, 1996 General Election, by having a tobacco prevention and education program serving every county.

(1) Eligibility for Grant Awards:

(a) The Oregon Public Health Division shall accept for funding a maximum of one proposal per county or consortium of counties;

(b) For the purposes of this program the local health department shall be considered the Local Lead Agency in each county for submitting a proposal, except as provided under (c) or (d) below;

(c) Any local health department that elects not to submit a proposal under this section may form a consortium with one or more health department(s) and jointly submit one proposal;

(d) Any local health department electing not to submit a proposal by itself or in consortium with another county(s) shall designate an appropriate local governmental or not-for-profit health-related organization and shall send a letter to the Director identifying such organizations as the Local Lead Agency for that county;

(e) Any Local Lead Agency designated under subsection (d) above shall be eligible to submit a proposal for that county directly to the Oregon Public Health Division;

(f) A local health department may revoke the designated Local Lead Agency under subsection (d) upon mutual agreement of both the local health department and the Local Lead Agency. The health department and the Local Lead Agency shall jointly notify the Director of the agreement. If the local health department and the Local Lead Agency do not reach an agreement on the revocation of the designation under subsection (d) above the Director may determine whether the revocation is in the best interest of the public health.

(2) Development of the Request for Proposals (RFP) Document. The RFP document for local coalitions and community-based programs shall be developed by the Director in consultation with representatives from appropriate groups, including but not limited to the Governor’s Tobacco Reduction Advisory Committee, the Tobacco-Free Coalition of Oregon, the Conference of Local Health Officials, the Oregon Department of Education, the Oregon Office on Alcohol and Drug Abuse Programs, and the Centers for Disease Control and Prevention.

(3) Grant Application Process. Proposals shall be submitted in a format and within a time frame prescribed by the Director, and shall include, but are not limited to:

(a) A list of local coalition members and a description of their roles;

(b) Specific local program goals, objectives, activities and evaluation plans; and

(c) A detailed budget for use of grant funds.

(4) Review of Proposals:

(a) Proposals shall be evaluated by a review committee appointed by the Director. The Director has the authority to include on the review committee persons not employed by the Oregon Public Health Division, including experts in the field of tobacco use reduction;

(b) The Director may reject any application not in compliance with the RFP’s instructions;

(c) Proposals shall be evaluated according to the criteria described in the RFP;

(d) The Director may request additional information from an applicant prior to and during the review of a proposal.

(5) Awarding of Funds:

(a) Funds shall be awarded based on the quality of proposals in addressing the RFP requirements;

(b) The Director may negotiate modifications of the applicant’s proposal on the basis of availability of funds, and merit of application. In these cases funds shall be awarded only after such modifications have been agreed upon by both the Director and the Local Lead Agency;

(c) The Director shall determine final funding levels.

Statutory/Other Authority: ORS 431.834
Statutes/Other Implemented: ORS 431.831 - 431.836
History:
HD 11-1997, f. & cert. ef. 9-12-97

333-010-0350
Tobacco Prevention and Education Program: Statewide Public Awareness and Education Programs

The goal of the Oregon Public Health Division under this section is to fulfill the purpose and intent of Chapter 2 of Oregon Laws of 1997, approved by the people as Ballot Measure 44, at the November 5, 1996 General Election, by developing a statewide tobacco public awareness and education program.

(1) Eligibility for Grant Awards. Under this section the Director may award one or more contracts to providers of public relations, public awareness, public education or communications services.

(2) Development of the Request for Proposals (RFP) Document. The RFP for Statewide Public Awareness and Education Programs shall be developed by the Director in consultation with representatives from appropriate groups, which may include, but are not be limited to, the Governor’s Tobacco Reduction Advisory Committee, the Tobacco-Free Coalition of Oregon, the Oregon Department of Education, the Office of Alcohol and Drug Abuse Programs, and the Centers for Disease Control and Prevention.

(3) Grant Application Process:

(a) The Director may award one or more contracts using the RFP process provided for in OAR, chapter 125;

(b) Proposals responding to the RFP must contain, but shall not be limited to:

(A) A plan to develop and utilize educational messages about the dangers of tobacco use, the harm of second-hand smoke and the benefits of cessation;

(B) Detailed budget for proposed use of funds;

(C) Plans for evaluating effectiveness of contract services.

(c) The RFP shall include but is not limited to the following elements:

(A) Minimum standards and qualifications required from the contractor(s) to be eligible to provide the service;

(B) The evaluation process and criteria to be used to select the contractor(s), including weights or points applicable to each criterion;

(C) The manner in which the proposers cost and pricing proposal will be evaluated;

(D) A requirement to provide a list of similar services completed, with references addressing past performance;

(E) The closing date and time and place of delivery for the proposal;

(F) Reservation about the right to seek clarification of each proposal, and the right to negotiate a final contract within the scope of the work described in the RFP;

(G) Reservation of the right to reject any or all proposals, if rejection would be in the public interest;

(H) Reservation of the right to cancel the solicitation, if such cancellation would be in the public interest;

(I) A sample of the standard contract provisions;

(J) The possibility of pre-proposal meetings and post-proposal interviews and presentations; and

(K) Any other information appropriate to, evaluate, rank, and select the best proposal(s).

(4) Review of Proposals:

(a) Proposals shall be evaluated by a review committee appointed by the Director. The Director may include on the review committee persons not employed by the Oregon Public Health Division, including experts in the field of tobacco use reduction;

(b) The Director may reject any application not in compliance with the RFP’s instructions;

(c) Evaluation criteria may include, but not be limited to, the following:

(A) Availability and capability to perform the work;

(B) Staff experience on comparable projects and services;

(C) Demonstrated ability to complete similar projects and services on time and within budget;

(D) References from clients, public and private;

(E) Performance history in meeting deadlines, submitting accurate estimates, producing quality work, and meeting financial obligations;

(F) Status and quality of any required licensing or certification;

(G) Knowledge and understanding of the required services as shown through the proposed approach to staffing and scheduling needs;

(H) Fees or costs;

(I) Results from oral interviews, if conducted;

(J) Availability of any required specific resources or equipment;

(K) Geographic proximity to the project or the area where the services will be performed;

(L) Identity of proposed subcontractors and their qualifications; and

(M) Any other criteria deemed relevant to the provision of services.

(5) Awarding of Funds:

(a) Ranking of proposals shall be based on all information obtained by the reviewers during the evaluation process. Budget shall be considered, but shall not necessarily govern selection of the contractor(s);

(b) Contracts entered into under the formal selection procedure may be amended, provided the original contract allows for the particular amendment and the services to be provided under the amendment are included within, or directly related to, the scope of the project or the scope of the services described in the RFP;

(c) The Director may negotiate modifications of the applicant’s proposal and award funds only after such modifications have been agreed upon by the Director and the applicant;

(d) The Director shall determine the final contract awards and funding levels.

Statutory/Other Authority: ORS 431.834
Statutes/Other Implemented: ORS 431.831 - 431.836
History:
HD 11-1997, f. & cert. ef. 9-12-97

333-010-0360
Tobacco Prevention and Education Program: Statewide and Regional Projects Programs

The goal of the Oregon Public Health Division under this section is to fulfill the purpose and intent of Chapter 2 of Oregon Laws of 1997, approved by the people as Ballot Measure 44, at the November 5, 1996 General Election, by developing various programs serving special populations through innovative projects for tobacco prevention and education.

(1) Eligibility for Grant Awards:

(a) The Director may award grants under this section to public and/or private agencies using the process specified in OAR, chapter 125;

(b) Agencies eligible to apply for grants under this section shall be those capable of developing and implementing special statewide or regional projects, including but not limited to those:

(A) Serving multi-cultural populations, including, but not limited to, Indian Tribes;

(B) Developing and implementing a toll-free telephone service, which includes counseling, referral to cessation resources, and follow-up;

(C) Developing and implementing regional and statewide training, and technical assistance on the best practices for effective tobacco prevention programs; and

(D) Developing other innovative, demonstration, and research projects to decrease tobacco initiation by youth, promote cessation for youth and adults, and promote smoke-free communities.

(2) Development of the Request for Proposals (RFP) Document. The RFP for Statewide and Regional Special Projects shall be developed by the Director in consultation with representatives from appropriate groups, which may include, but are not limited to, the Governor’s Tobacco Reduction Advisory Committee, the Tobacco-Free Coalition of Oregon, the Oregon Department of Education, the Office of Alcohol and Drug Abuse Programs, and the Centers for Disease Control and Prevention.

(3) Grant Application Process:

(a) The Director may award one or more grants using a RFP process provided for in OAR, chapter 125;

(b) Under this section, proposals shall be requested for programs that serve special populations, and for regional or statewide innovative and unique tobacco prevention and education projects;

(c) Grants may be awarded for, but are not limited to, the following: a toll-free telephone service, training and technical assistance, special projects to decrease tobacco initiation by youth, to promote cessation for youth and adults, and to promote smoke-free communities;

(d) The RFP shall address but not be limited to the following elements:

(A) Minimum standards and qualifications required from the proposer(s) to be eligible to provide the service;

(B) Statement of work, tied to measurable objectives;

(C) Detailed budget;

(D) Plan for evaluating effectiveness and impact of proposed activities;

(E) The evaluation process and criteria to be used to select the contractor(s), including weights or points applicable to each criterion;

(F) The manner in which the proposers cost and pricing proposal will be evaluated;

(G) A requirement to provide a list of similar services completed, with references addressing past performance;

(H) The closing date and time and place of delivery for the proposal;

(I) Reservation about the right to seek clarification of each proposal, and the right to negotiate a final contract within the scope of the work described in the RFP;

(J) Reservation of the right to reject any or all proposals, if rejection would be in the public interest;

(K) Reservation of the right to cancel the solicitation, if such cancellation would be in the public interest;

(L) A sample of the standard contract provisions;

(M) The possibility of pre-proposal meetings and post-proposal interviews and presentations; and

(N) Any other information appropriate to evaluate, rank, and select the best proposal(s).

(4) Review of Proposals:

(a) Proposals shall be evaluated by a review committee appointed by the Director. The Director has the authority to include on the review committee persons not employed by the Oregon Public Health Division, including experts in the field of tobacco use reduction;

(b) Evaluation criteria may include, but not be limited to, the following:

(A) Availability and capability to perform the work;

(B) Staff experience on comparable projects and services;

(C) Demonstrated ability to complete similar projects and services on time and within budget;

(D) References from clients, public and private;

(E) Performance history in meeting deadlines, submitting accurate estimates, producing quality work, and meeting financial obligations;

(F) Status and quality of any required licensing or certification;

(G) Knowledge and understanding of the required services as shown through the proposed approach to staffing and scheduling needs;

(H) Fees or costs;

(I) Results from oral interviews, if conducted;

(J) Availability of any required specific resources or equipment;

(K) Geographic proximity to the project or the area where the services will be performed;

(L) Identity of proposed subcontractors and their qualifications; and

(M) Any other criteria deemed relevant to the provision of services.

(5) Awarding of Funds:

(a) The final ranking of proposals will be based on all information obtained by the reviewers during the evaluation process. Price will be considered, but will not necessarily govern selection of the contractor(s);

(b) Contracts entered into under the formal selection procedure may be amended, provided the original contract allows for the particular amendment and the services to be provided under the amendment are included within, or directly related to, the scope of the project or the scope of the services described in the RFP;

(c) The Director may negotiate a modification of the applicant’s proposal, and award funds only after such modification has been agreed upon by the Director and the applicant;

(d) The Director shall determine final grant awards and funding levels.

Statutory/Other Authority: ORS 431.834
Statutes/Other Implemented: ORS 431.831 - 431.836
History:
HD 11-1997, f. & cert. ef. 9-12-97

333-010-0370
Tobacco Prevention and Education Program: Reporting

(1) During each biennium the Director shall prepare a report regarding the awarding of grants from the Tobacco Use Reduction Account and the formation of public-private partnerships in connection with the receipt of funds from the account. The report shall include an evaluation of the effectiveness of the program funded by the Tobacco Use Reduction Account.

(2) The Public Health Division shall present the report to the Governor and to those committees of the Legislative Assembly to which matters of public health are assigned.

Statutory/Other Authority: ORS 431.834
Statutes/Other Implemented: ORS 431.831 - 431.836
History:
HD 11-1997, f. & cert. ef. 9-12-97

333-010-0600
Childhood Diabetes Database: Definitions

(1) “Case” means a reportable case of type 1 or type 2 diabetes in an individual who is 18 years of age or younger, and a resident of Oregon.

(2) “Diabetes Program” means the Oregon Diabetes Prevention and Control Program of Oregon Health Authority, Public Health Division, the program authorized to collect, receive, and maintain a childhood diabetes database under ORS 444.300.

(3) “Date of diagnosis” means the date of initial diagnosis by a practitioner of a case of diabetes being reported to the Diabetes Program.

(4) “Effective Date” means the date after which reporting by schools and physicians shall be required.

(5) “Identifying information” includes, but is not limited to the student’s name, address, date of birth, and information that identifies the individual or could be used to identify the individual, and relates to the individual's past, present or future health, and the provision of healthcare to the individual. "Identifying information" also includes “Individually Identifiable Health Information” as that is defined in the 1996 Health Insurance Portability and Accountability Act and “Directory Information” as that is defined in the Federal Family Educational Right to Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99).

(6) “Practitioner” means any person whose professional license allows him or her to diagnose or treat diabetes patients.

(7) “Reportable childhood diabetes” means a medical condition, occurring in a person aged 18 years or younger, and meeting the criteria for diagnosis of diabetes in a child as outlined by the American Diabetes Association. (Reference: American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care 2005; 28: S4-S36.)

(8) “School” means any public, public charter, or registered private school in Oregon.

[Publications: Publications referenced are available from the agency.]

Statutory/Other Authority: ORS 444.300
Statutes/Other Implemented: ORS 444.300-444.330
History:
PH 6-2007, f. & cert. ef. 4-13-07

333-010-0610
Childhood Diabetes Database: General Authority and Purpose

According to ORS 444.300(1), subject to available funding, including gifts, grants or donations, the Diabetes Program shall establish a uniform, statewide database for the collection of information on type 1 and type 2 diabetes occurring in children in Oregon. The purposes of the database shall be to collect and serve as a repository for data about the prevalence and incidence of diabetes occurring in the pediatric population of this state and to make the data available for scientific and medical research and for assistance in making decisions about the allocation of public resources.

Statutory/Other Authority: ORS 444.300
Statutes/Other Implemented: ORS 444.300-444.330
History:
PH 6-2007, f. & cert. ef. 4-13-07

333-010-0620
Childhood Diabetes Database: Reporting Requirements for Schools

(1) The Diabetes Program shall conduct an annual survey to collect information about diabetes occurring in students age 18 years or younger. Preferably the survey will be completed and returned to the Diabetes Program within 30 days of the date the survey or electronic survey link is sent out, but in no event, later than June 15 of each year.

(2) Each school surveyed, upon receipt of written consent of the parent, guardian (or of the student if age18 years) shall report to the Diabetes Program for each student enrolled at the school, during the academic year, who has type 1 or type 2 diabetes, the following information:

(a) The name and address of the student;

(b) The sex of the student;

(c) The date of birth of the student;

(d) The type of diabetes diagnosed (if known);

(e) The date of diagnosis; (if known); and

(f) The name of the child’s practitioner (if known).

Statutory/Other Authority: ORS 444.300
Statutes/Other Implemented: ORS 444.300-444.330
History:
PH 6-2007, f. & cert. ef. 4-13-07

333-010-0630
Childhood Diabetes Database: Reporting Requirements for Practitioners

(1) Upon diagnosing or first treating a case of type 1 or type 2 diabetes in an Oregon child, a practitioner shall report the following information to the Diabetes Program:

(a) The name and address of the child;

(b) The sex of the child;

(c) The date of birth of the child;

(d) The type of diabetes diagnosed;

(e) The date of diagnosis or first treatment by the reporting practitioner; and

(f) The measured height and weight of the child.

(2) The practitioner shall report the case to the Diabetes Program within 30 days of diagnosing or first treating the child.

(a) The practitioner shall report the case using the Diabetes Program's Practitioner Childhood Diabetes Report Form. The report may be sent to the Diabetes Program by mail, electronically, or by fax. Copies of the form, and directions for submission may be obtained from the Diabetes Program, 800 NE Oregon Street, Portland, Oregon 97232; or may be downloaded through the Diabetes Program’s website.

(b) The Diabetes Program may elect to supplement passive reporting from practitioners with active solicitation of reporting through periodic contacts with certain practitioners.

Statutory/Other Authority: ORS 444.300
Statutes/Other Implemented: ORS 444.300-444.330
History:
PH 6-2007, f. & cert. ef. 4-13-07

333-010-0640
Childhood Diabetes Database: Confidentiality and Access to Data

(1) All identifying information regarding individual patients, reporting schools, and practitioners reported pursuant to OAR 333-010-0620 and 333-010-0630 shall be confidential and privileged. Except as required in connection with the administration or enforcement of public health laws or rules, no public health official, employee or agent shall be examined in an administrative or judicial proceeding as to the existence or contents of data collected under the childhood diabetes database.

(2) The information collected and maintained by the diabetes database shall be stored in physically secure locations and in a technologically secure manner, and shall be used solely for the purposes stated in ORS 444.330

Statutory/Other Authority: ORS 444.300
Statutes/Other Implemented: ORS 444.300-444.330
History:
PH 6-2007, f. & cert. ef. 4-13-07

333-010-0650
Childhood Diabetes Database: Research Studies

(1) Prior to any confidential data from the database being released to a researcher, the researcher must:

(a) Obtain approval from Oregon Health Authority, Public Health Division Institutional Review Board, established in accordance with 45 C.F.R. 46.

(b) Obtain approval from the Diabetes Program.

(2) In reviewing research proposals for approval under section (1)(b) of this rule, the Diabetes Program, with input from its advisory committee, shall consider whether the research will:

(a) Further knowledge of the prevalence and incidence of diabetes occurring in the pediatric population;

(b) Better define causes of and treatment for childhood diabetes; or

(c) Inform decision-making about the allocation of public resources.

(3) The Diabetes Program shall also ensure that the research proposal has been reviewed for scientific excellence by a nationally recognized peer review group.

(4) Prior to confidential information being released to a researcher, the Diabetes Program will contact the family and offer the option to decline contact regarding research opportunities.

Statutory/Other Authority: ORS 444.300
Statutes/Other Implemented: ORS 444.300-444.330
History:
PH 6-2007, f. & cert. ef. 4-13-07

333-010-0660
Childhood Diabetes Database: Advisory Committee

(1) The Diabetes Program may convene an advisory committee to make recommendations regarding the Diabetes Program's use of the database, and to assist in reviewing research proposals under OAR 333-010-0650.

(2) Advisory committee members may not have access to confidential information provided to the program under ORS 444.300 to 444.320.

(3) The advisory committee shall be composed of persons with a professional or personal interest in childhood diabetes.

Statutory/Other Authority: ORS 444.300
Statutes/Other Implemented: ORS 444.300-444.330
History:
PH 6-2007, f. & cert. ef. 4-13-07

333-010-0700
Dental Pilot Projects: Purpose

(1) The Dental Pilot Projects are intended to evaluate the quality of care, access, cost, workforce, and efficacy by teaching new skills to existing categories of dental personnel; developing new categories of dental personnel; accelerating the training of existing categories of dental personnel; or teaching new oral health care roles to previously untrained persons. The purpose of Dental Pilot Projects are to encourage the development of innovative practices in oral health care delivery systems with a focus on providing care to underserved populations that evidence-based studies have shown have the highest disease rates and the least access to dental care.

(2) These rules establish the requirements of Dental Pilot Project applications; the process for reviewing applications; approval or denial of applications; minimum standards for approved projects; evaluation and monitoring of Dental Pilot Projects; suspension or termination of an approved Dental Pilot Project; and discontinuation or closure of a project.

(3) These rules apply to all dental pilot projects. Dental pilot projects must come into compliance with new minimum standards requirements in OAR 333-010-0760 by July 1, 2020.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0710
Dental Pilot Projects: Definitions

For purposes of OAR 333-010-0700 through 333-010-0820, the following definitions apply:

(1) "Adverse event" means unnecessary harm due to dental treatment.

(2) "Applicable standard of care" means the standard of care that applies to a trainee and is the same standard of care that applies to a person performing the same services with a license.

(3) "Authority" means the Oregon Health Authority.

(4) "Business day" means any 24-hour day other than a Saturday, Sunday or federal or state legal holiday.

(5) "Clinical evaluator" means a dentist, licensed in the State of Oregon or another state, who is responsible for conducting an independent clinical evaluation of an approved dental pilot project; who is unaffiliated with the project; and who has no financial or commercial interest in the project.

(6) "Clinical instructor" means a person who:

(a) Is certified or licensed in the field for which clinical instruction is occurring;

(b) Is currently licensed in dentistry or dental hygiene or licensed or certified in another appropriate health discipline; and

(c) Has current knowledge and skill in topics they will teach.

(7) "Clinical phase" means the time period of an approved project where a trainee treats patients, supervised by an instructor, applying knowledge presented by an instructor.

(8) "Complications" means a disease or injury that develops during or after the treatment of an earlier disorder.

(9) "Didactic phase" means the time period of a project during which trainees are presented with an organized body of knowledge by an instructor.

(10) "Employment/utilization phase" means the time period of a project where trainees are applying their didactic and clinical knowledge and skills in an employment setting under the supervision of a supervisor.

(11) "Employment/utilization site" means an Authority approved location, locations, or class of locations where a trainee or trainees provide care during the employment/utilization phase.

(12) "Non-clinical instructor" is a person with specific training or expertise as demonstrated through a degree or experience relevant to the content of instruction.

(13) "Program" means the Dental Pilot Projects Program administered by the Authority.

(14) "Program staff" means the staff of the Authority with responsibility for the Dental Pilot Projects Program.

(15) "Project" means a Dental Pilot Project approved by the Authority.

(16) "Project director" means the individual designated by the sponsor of a dental pilot project who is responsible for the conduct of the dental pilot project staff, instructors, supervisors, and trainees.

(17) "Project Dental Director" means an individual who is actively responsible for oversight of the dental pilot project and who is a dentist or dental hygienist:

(a) Licensed in the State of Oregon; or

(b) A dentist authorized to practice in the State of Oregon but is exempt from state licensure under ORS 679.020 or 679.025; or

(c) A dental hygienist authorized to practice in the State of Oregon but is exempt from state licensure under ORS 680.020.

(18) "Project evaluation" means a systematic method for collecting, analyzing and using data to examine the effectiveness and efficiency of a pilot project by the project sponsor.

(19) "Reviewer" means an individual designated by the Authority to review and comment on all or portions of a project application.

(20) "Sponsor" means an entity that is a non-profit educational institution, professional dental organization, community hospital or clinic, coordinated care organization or dental care organization, tribal organization or clinic that:

(a) Submits a dental pilot project application; and

(b) If a dental pilot project is approved by the Authority, has overall responsibility for ensuring the project complies with these rules.

(21) "Standard operating procedures" means the written documented processes that describe the project’s regularly recurring operations to ensure that the operations are carried out correctly and consistently and in accordance with these rules.

(22) "Supervisor" means an individual, licensed in the State of Oregon to practice dentistry, designated by the sponsor to oversee trainees at each approved employment/utilization site, with the skills necessary to teach trainees the scope of practice outlined in the approved project.

(23) "These rules" means OAR 333-010-0700 through 333-010-0820.

(24) "Trainee" means an individual who is part of an existing category of dental personnel; a new category of dental personnel; or a category of previously untrained dental personnel who has agreed to participate in a project and will be taught the scope of practice identified by the project.

(25) "Training program" means an organized educational program within a project that includes at least a didactic phase and a clinical phase.

(26) "Underserved populations" means groups of individuals that evidence-based studies have shown have the highest disease rates and the least access to dental care including, but not limited to:

(a) American Indians or Alaska Natives;

(b) Individuals earning up to 200 percent of the federal poverty level;

(c) Medicaid-eligible individuals;

(d) Migrant farmworkers and their family members; and

(e) Uninsured individuals.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0720
Dental Pilot Projects: Application Procedure

(1) A sponsor who wishes to operate a pilot project must submit an application in a form and manner prescribed by the Authority.

(2) The application must demonstrate how the pilot project will comply with the requirements of these rules.

(3) The Authority will not accept new applications if it determines:

(a) There are a sufficient number of projects to provide a basis for testing the validity of the model as determined by the Authority.

(b) It does not have adequate resources to provide an appropriate level of oversight required by these rules.

(4) An application must include, at a minimum, the following information and documentation:

(a) The goals of the project, including whether the project can achieve at least one of the following:

(A) Teach new skills to existing categories of dental personnel;

(B) Accelerate the training of existing categories of dental personnel;

(C) Teach new oral health care roles to previously untrained personnel; or

(D) Develop new categories of dental personnel.

(b) Sponsor information:

(A) A description of the sponsor, including a copy of an organizational chart that identifies how the project relates organizationally to the sponsor;

(B) A copy of a document verifying the sponsor’s status as a non-profit educational institution, professional dental organization, community hospital or clinic, coordinated care organization or dental care organization, or a tribal organization or clinic;

(C) A description of the functions of the project director, project dental director, instructors, and other project staff;

(D) Documentation of the funding sources for the project;

(E) Documentation of liability insurance relevant to services provided by trainees; and

(F) A statement of previous experience in providing related health care services.

(c) Instructor and Supervisor information:

(A) The criteria used to select instructors and supervisors;

(B) Instructor-to-trainee ratio;

(C) The background of instructors in training techniques and methodology;

(D) The number of proposed supervisors and qualification of supervisors; and

(E) An explanation of how instructors and supervisors will be oriented to their roles and responsibilities and these rules.

(d) A training program that includes, but is not limited to, a description of:

(A) The instructional content required to meet the level of competence;

(B) The skills trainees are to learn;

(C) The methodology utilized in the didactic and clinical phases;

(D) The evaluation process used to determine when trainees have achieved the level of competence;

(E) The amount of time required to complete the didactic and clinical phases; and

(F) The level of competence the trainee shall have before entering the employment/utilization phase of the project.

(e) Trainee information:

(A) The criteria that will be used to select trainees;

(B) The number of proposed trainees;

(C) The proposed scope of practice for trainees; and

(D) Information regarding the background check process for participants to determine compliance with OAR 333-010-0760, Minimum Standards.

(f) Employment/utilization site information: A list of all locations or class of locations the proposed project intends for use during the employment/utilization phase where a trainee may provide care.

(g) Underserved population information:
(A) A list of the underserved populations the project intends to serve;

(B) Documentation demonstrating that the populations the pilot project intends to serve are underserved populations; and

(C) Documentation demonstrating that each of the project’s trainees or employment/utilization sites shall provide services to the underserved populations identified in the application at a rate of at least 51 percent of all individuals served by the trainee or employment/utilization site on a quarterly basis.

(h) Cost information:

(A) The average cost of preparing a trainee, including but not limited to the costs related to instruction, instructional materials and equipment, space for conducting didactic and clinical phases, and other pertinent costs;

(B) The estimated cost of care provided in the project; the likely cost of this care if performed by the trainees of the project; and the cost for provision of this care by current providers;

(C) A budget narrative that lists costs associated with key project areas, including but not limited to:

(i) Personnel and fringe benefits for project director, project dental director, instructors, and staff associated with the project;

(ii) Contractors and consultants to the project;

(iii) Materials and supplies used in the clinical, didactic, and employment/utilization phases of the project;

(iv) Equipment and other capital costs associated with the project; and

(v) Travel required for implementing and monitoring the project.

(i) An explanation of the feasibility of achieving the project objectives.

(j) A preliminary evaluation plan that includes, but is not limited to:

(A) How the project sponsor will monitor and evaluate the project, including but not limited to:

(i) How the project sponsor will monitor and evaluate the rate of underserved populations served by the pilot project’s trainees or employment/utilization sites; and

(ii) How the project sponsor will monitor and evaluate to ensure trainees are adequately supervised. Supervision of trainee must protect patient health and ensure minimum standards in OAR 333-010-0760 are met.

(B) A description of the key project activities and their intended effects;

(C) How the project sponsor intends to use the evaluation results for program improvement and decision making; and

(D) A description of how the project will measure its progress toward meeting the goals listed in the application, as described in subsection (4)(a) of this rule. The project must track and identify measurable project outcomes and metrics as outlined in the requirements under OAR 333-010-0780.

(k) An identified clinical evaluator who will conduct the clinical evaluation of the project in accordance with the evaluation plan.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0730
Dental Pilot Projects: Application Review Process

(1) The Authority shall review an application to determine if it is complete within 60 calendar days from the date the application was received.

(a) If an applicant does not provide all the information required, and the application is considered incomplete, then the Authority shall notify the applicant of the information that is missing and shall allow the applicant 30 calendar days to submit the missing information.

(b) If an applicant does not submit the missing information within the timeframe specified in the notice, then the application shall be rejected as incomplete. An applicant whose application is rejected as incomplete may reapply at any time.

(2) An application deemed complete will continue through a review process.

(3) The Authority may have individuals outside the Authority, including representatives of appropriate professional societies and licensing boards, review applications, but no individual who has contributed to or helped prepare an application will be permitted to conduct a review of that application.

(4) The Authority may request additional information from an applicant during the review process.

(5) Once the Authority completes an application review, a Notice of Intent to provisionally approve or deny an application will be provided to the applicant. The Notice will be sent to interested parties and will be posted for public comment for a period of 30 calendar days, along with a link to the application and other materials submitted by the applicant.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0740
Dental Pilot Projects: Project Application Provisional Approval or Denial

(1) Following the close of the public comment period described in OAR 333-010-0730, Application Review Process, the Authority shall review the public comments that were received and issue within 30 calendar days of the close of the public comment period:

(a) A provisional decision to grant approval of an application; or

(b) A denial of the application.

(2) If the application is provisionally approved, the project sponsor must comply with the requirements in OAR 333-010-0750, Provisional Approval; Final Approval, before it can receive final approval. Projects that receive provisional approval may begin to provide didactic training however they may not operate or treat live patients until final approval is received from the Authority.

(3) If the Authority denies the application, the denial must be in writing and must describe the reasons for the denial. An application may be denied for any of these reasons:

(a) The application does not demonstrate that the project will meet the minimum standards or other provisions in these rules;

(b) The application does not demonstrate each of the project’s trainees or employment/utilization sites shall provide services to the underserved populations identified in the application at a rate of at least 51 percent of the individuals served by the trainee or employment/utilization site on a quarterly basis;

(c) The application does not demonstrate that the project is financially feasible; or

(d) The Authority has previously approved a similar project.

(4) A sponsor whose project has been denied may not submit a new application within six months from the date the Authority denied the application.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0750
Dental Pilot Projects: Provisional Approval; Final Approval

(1) A project sponsor that has been provisionally approved must, within 90 calendar days of provisional project approval, submit the following to the Authority for  approval:

(a) A detailed evaluation and monitoring plan that meets the requirements in OAR  333-010-0780, Pilot Project Evaluation and Monitoring by Sponsor.

(b) Written standard operating policies and procedures for the project that ensure compliance with OAR 333-010-0760, Minimum Standards. Standard operating policies and procedures shall include, but are not limited to:

(A) Clinical policies and procedures that describe the steps required for implementation of the project at each site;

(B) Administrative policies and procedures that describe protocols;

(C) Administrative protocols for mandatory record keeping;

(D) Data collection policies and procedure protocols that:

(i) Require data capture and data entry, including identification of the staff positions or other individuals responsible for these activities;

(ii) Define policies for protection and security of patient data;

(E) The protocol for orientating supervisors to their roles and responsibilities; and

(F) The process for ensuring that potential problems and root causes for deviations and non-conformances are identified, possible consequences assessed, actions to prevent recurrence considered, and corrective actions are taken if necessary.

(2) The Authority will review the documentation required in section (1) of this rule and notify the project sponsor if the plan and policies and procedures are acceptable. The Authority may request additional information and may request that the project sponsor revise the plan or policies and procedures to meet the requirements in these rules.

(3) Once the Authority has received an acceptable plan and policies and procedures, it will notify the project sponsor that the project has been approved along with the plan and policies and procedures. The final approval letter shall include:

(a) The permitted scope of the project;

(b) Any conditions the Authority deems are necessary to protect patient safety or ensure minimum standards in OAR 333-010-0760 are met;

(c) Procedures for which the project will be required to obtain written informed consent for treatment under OAR 333-010-0770, Informed Consent; and

(d) The length of time the project can operate - from between three to five years or a sufficient amount of time to evaluate the validity of the project.

(4) The Authority shall notify the Oregon Board of Dentistry when a project is approved.

(5) The Authority may deny an application if:

(a) The project fails to submit the documents described in section (1) that satisfy these rules;

(b) The project fails to submit additional information or revised plans, policies, or procedures that are acceptable to the Authority as required by section (2) of this rule; or

(c) The documentation submitted by the project under this rule fails to demonstrate that the project will meet the minimum standards or other provisions in these rules.

(6) A denial issued under this rule must be in writing and must describe the reasons for the denial.

(7) A sponsor whose project has been denied may not submit a new application within six months from the date the Authority denied the application.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 76-2020, amend filed 10/28/2020, effective 10/28/2020
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0760
Dental Pilot Projects: Minimum Standards

An approved dental pilot project must:

(1) Provide for patient safety and that the applicable standard of care is met as follows:

(a) Comply with informed consent in accordance with OAR 333-010-0770, Informed Consent;

(b) Prohibit a trainee from performing procedures the trainee is not capable of performing based on the trainee’s level of education, training and experience, physical or mental disability, or which are outside of the trainee’s approved scope of practice as outlined in the approved application by the Authority;

(c) Provide or arrange for emergency treatment for a patient currently receiving treatment and needs emergency care;

(d) Not use the behavior management technique of Hand Over Mouth (HOM) or Hand Over Mouth Airway Restriction (HOMAR) on any patient;

(e) Comply with ORS 419B.005 to 419B.010 related to the mandatory reporting of child abuse;

(f) Comply with ORS 453.605 to 453.755 or rules adopted pursuant thereto relating to the use of X-ray machines;

(g) Comply with ORS 679.520 or rules adopted pursuant thereto relating to the treatment of dental waste materials;

(h) Comply with ORS 679.535 or rules adopted pursuant thereto relating to the requirement to test heat sterilization devices; and

(i) Ensure that project participants involved in direct patient care:

(A) Have not been convicted of any crimes, within the last 10 years, that is a crime of violence or crime of dishonesty.

(B) Have not been denied or disciplined by a state entity that issues licenses or certificates.

(j) Ensure adequate supervision and evaluation of trainees, including but not limited to:

(A) Timely review of trainee procedures and addressing any deficiencies;

(B) Monitoring for adverse events and addressing any deficiencies; and

(C) Monitoring and evaluating trainees and addressing any deficiencies.

(2) Ensure that participants in the project, including trainees, do not engage in unprofessional conduct as that is defined in ORS 676.150.

(3) Ensure that an accurate patient record is prepared and maintained for each person receiving dental services, regardless of whether any fee is charged. The record shall contain the name of the trainee rendering the service and include, but is not limited to:

(a) Name and address and, if a minor, name of guardian;

(b) Date and description of examination and diagnosis;

(c) An entry that informed consent has been obtained in accordance with OAR 333-010-0770, Informed Consent;

(d) Date and description of treatment or services rendered;

(e) Date and description of all radiographs, study models, and periodontal charting;

(f) Health history; and

(g) Date, name of, quantity of, and strength of all drugs dispensed, administered, or prescribed.

(4) Have a sufficient number and distribution of qualified clinical and non-clinical instructors to meet project objectives, as identified in the approved application.

(5) Provide instruction to trainees following the training program outlined in the approved application by the Authority.

(6) Assure that trainees achieve a minimal level of competence before they are permitted to enter the employment/utilization phase. The sponsor must provide notice to the Authority within 14 business days of a trainee entering the employment/utilization phase. The notice shall include, but is not limited to, the following:

(a) Name, work address, electronic mail address and telephone number of the trainee;

(b) Name, work address, electronic mail address, telephone number and license number of the supervisor;

(c) Information regarding the trainee’s responsibilities and limitations under Oregon Laws 2011, chapter 716 and these rules; and

(d) A disclaimer that there is no assurance of a future change in law or regulations that will allow them to practice without a license outside an approved dental pilot project.

(e) Trainee monitoring records shall be provided to the Authority.

(7) Comply with the requirements of the Dental Pilot Projects statute, Oregon Laws 2011, chapter 716; these rules; and the approved application including, but not limited to, the evaluation and monitoring plan.

(8) Evaluate quality of care, access, cost, workforce, and efficacy in accordance with the evaluation and monitoring plan approved by the Authority and as described in OAR 333-010-0780, Pilot Project Evaluation and Monitoring by Sponsor.

(9) Within 24 hours of any incident involving a patient in the care of a trainee which results in any medical occurrence that is life-threatening, requires hospitalization, results in disability or permanent damage, requires medical or surgical intervention or results in death, the sponsor must ensure that a detailed written report, along with the patient’s complete dental records, is submitted to the Authority by the supervising dentist.

(10) Submit detailed quarterly monitoring reports in a format prescribed by the Authority that include but are not limited to the following information for the previous quarter:

(a) Accomplishments or highlights.

(b) Challenges faced and continuous quality improvement activities.

(c) Updated project timeline.

(d) Data reports:

(A) A comprehensive breakdown of each of the data points the project is capturing in its approved evaluation and monitoring plan including anonymized client level data.

(B) Data generated by the clinical evaluator.

(C) Number and type of any adverse event or complication that occurred during the reporting period.

(D) Underserved population report: Information identifying the percentage of patients served by each of the pilot project’s trainees or employment/utilization sites that are within the underserved population identified in the application.

(11) Follow written standard operating policies and procedures approved by the Authority as outlined in OAR 333-010-0750, Provisional Approval; Final Approval.

(12) Use templates and follow guidelines for the submission of documents and other reporting requirements as prescribed by the Authority.

(13) Provide care only at Authority approved employment/utilization sites.

(14) Demonstrate that each of the pilot project’s trainees or employment/utilization sites provides care to the underserved populations identified in the application at a rate of at least 51 percent of the total individuals served by the trainee or employment/utilization site on a quarterly basis.

(15) Exemption:

(a) Pilot projects may seek an exemption for each employment/utilization site as defined in OAR 333-010-0710 from the requirement to submit quarterly underserved population reports by submitting documentation demonstrating the employment/utilization site falls within an exemption category listed below. The Authority shall respond to the exemption request in writing.

(b) The Authority may request additional documentation demonstrating the employment/utilization site currently qualifies for an exemption or the rate described in section (14).

(c) A pilot project must immediately notify the Authority if an employment/utilization site no longer qualifies for exemption and begin submitting quarterly underserved population reports for that employment/utilization site.

(d) Exemption-eligibility. Employment/utilization sites as defined in OAR 333-010-0710 that only provide services via the following are eligible for an exemption:

(A) Community Mental Health Centers (CMHC);

(B) Federally-Qualified Health Centers (FQHCs) that are recipients of Public Health Service Act Section 330 grant funds;

(C) U.S. Health Resources & Services Administration (HRSA) Designated Health Centers;

(D) Indian Health Service Facilities;

(E) Tribally-Operated 638 Health Programs as defined by HRSA;

(F) Urban Indian Health Programs (ITUs) as defined by the Indian Health Service;

(G) State or local health departments;

(H) Substance Abuse and Mental Health Services Administration (SAMHSA) certified opioid treatment programs, office-based opioid treatment programs and non-opioid outpatient substance use disorders treatment facilities; and

(I) Other designation or criteria as determined by the Authority.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0770
Dental Pilot Projects: Informed Consent

(1) A sponsor must ensure that each patient or person legally authorized to provide consent on behalf of the patient:

(a) Is provided written information about the dental pilot project and who will be providing treatment;

(b) Gives written consent to be treated by the dental pilot project trainee; and

(c) Gives informed consent for treatment by the trainee.

(2) Written information about the project and who will be providing treatment must include, but is not limited to:

(a) An explanation of the role and status of the trainee, any certification or licenses a trainee may hold, the education and training of the trainee and the availability of the trainee’s supervisor for consultation;

(b) An explanation that the patient can refuse care from a trainee without penalty for such a request; and

(c) A statement that consenting to treatment by a trainee does not constitute assumption of risk by the patient.

(3) At a minimum, the following language must be included on the document that requests consent to be treated by the dental pilot project:

"I ____________________ [name of patient or person acting on patient’s behalf] have received information about this dental pilot project and provider type. I have been given the opportunity to ask questions and have them fully answered. I have read and understand the information and I agree to the trainee of this project providing me treatment."

_____________________________                                                        ___________

Signature of patient or person acting on patient’s behalf                             Date

(4) Informed consent for treatment:

(a) Each patient must give informed consent to the procedure. Informed consent means the consent to a procedure obtained by:

(A) Providing a thorough and easily understood explanation to the patient, or patient's guardian, of the proposed procedures, any available alternative procedures and any risks associated with the procedures; and

(B) Asking the patient, or the patient's guardian, if there are any questions and providing thorough and easily understood answers to all questions asked.

(b) Patient records must document an entry that informed consent for treatment has been obtained and the date the informed consent was obtained. Documentation may be in the form of an acronym such as "PARQ" (Procedure, Alternatives, Risks and Questions) or "SOAP" (Subjective Objective Assessment Plan) or their equivalent;

(c) Informed consent for treatment must be obtained in writing for procedures identified by the Authority in the application approval letter, and such consent must be included and documented in the patient’s record; and

(d) A trainee may not perform any procedure for which the patient or patient’s guardian has not given informed consent provided; however, in the event of an emergency situation, if the patient is a minor whose guardian is unavailable or the patient is unable to respond, a trainee may render treatment in a reasonable manner according to community standards and in accordance with the trainees approved scope of practice.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0780
Dental Pilot Projects: Pilot Project Evaluation and Monitoring by Sponsor

A Project Evaluation and Monitoring Plan required under OAR 333-010-0750, Provisional Approval; Final Approval, must include, but is not limited to:

(1) A logic model to depict the project activities and intended effects;

(2) A description of key evaluation questions to be addressed by the pilot project, including relevant process and outcome measures;

(3) A description of how the project will measure progress towards the goals identified in the application. Progress measurements must include quantitative metrics;

(4) A detailed description of the baseline data and information to be collected about the availability or provision of oral health care services, or both, prior to utilization phase;

(5) A detailed description of baseline data and information to be collected about trainee performance, patient and community satisfaction, and cost effectiveness;

(6) A detailed description of the methodology and data sources to be used in collecting and analyzing the data about trainee performance, acceptance by patients, quality of care and cost effectiveness;

(7) Defined measures to evaluate safety and quality of care provided;

(8) A detailed description of how the project sponsor shall comply with:

(a) All minimum standards in OAR 333-010-0760, including but not limited to adequate supervision of trainees; and

(b) All terms and conditions of the approved application, including any amendments.

(9) A process for ongoing quarterly monitoring in accordance with OAR 333-010-0760, Minimum Standards; and

(10) A process for regular evaluation of project activities across the lifecycle of the project for continuous quality improvement purposes.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0790
Dental Pilot Projects: Authority Responsibilities

(1) Project monitoring. Program staff shall monitor and evaluate approved projects which shall include, but is not limited to:

(a) Periodically requesting written information from the project to ascertain the progress of the project in meeting its stated objectives and in complying with program statutes and regulations:

(b) Periodic, but at least annual, site visits to one or more project offices, employment/utilization sites, or other locations where trainees are being prepared or utilized; and

(c) Reviewing the quarterly reports submitted by the project as described in OAR 333-010-0760, Minimum Standards.

(2) Advisory committee. The Authority may convene an advisory committee for each approved dental pilot project.

(a) Individuals eligible to serve on an advisory committee include but are not limited to:

(A) Representatives from:

(i) The Oregon Board of Dentistry;

(ii) Professional dental organizations or societies;

(iii) Educational institutions;

(iv) Health systems; and

(v) Individuals representing the target population served by the pilot project.

(B) Individuals with an interest in public health, oral health or expanding access to medical and dental care.

(b) The purpose of the advisory committee is to gather its members’ collective knowledge, experience, expertise, and insight to assist the Authority in meeting its responsibilities.

(c) If the Authority convenes an advisory committee it will solicit members for an advisory committee by public announcement; Individuals interested in serving on the committee are required to complete an application.

(d) From the applications received, the Authority will appoint no more than 15 members who are willing to undertake the duties of an advisory committee member and adhere to the committee charter adopted by the Authority. The Authority will notify each applicant in writing whether they have been appointed to the committee.

(e) An advisory committee member must:

(A) Attend meetings;

(B) Review approved pilot project quarterly reports at the request of the Authority;

(C) Attend approved pilot project site visits if invited; and

(D) Comply with any confidentiality requirements established by the Authority.

(3) Site visits.

(a) Site visits shall include, but are not limited to:

(A) Determination that adequate patient safeguards are being utilized;

(B) Validation that the project is complying with the approved or amended application;

(C) Interviews with project participants and recipients of care; and

(D) Reviews of patient records to monitor for patient safety and the applicable standard of care.
(b) If the Authority has convened an advisory committee, representatives of the committee may be invited by the Authority to participate in the site visit though the Authority may, at its discretion, limit the number of members who can participate;

(c) Written notification of the date, purpose and principal members of the site visit team shall be sent to the project director at least 90 calendar days prior to the date of the site visit;

(d) Plans to interview trainees, supervisors, and patients or to review patient records shall be made in advance through the project director;

(e) An unannounced site visit may be conducted by program staff if program staff have concerns about patient or trainee safety;

(f) The Authority will provide the project sponsor with at least 14 business days to submit to the Authority required patient records, data or other documents as required for the site visit; and

(g) Following a site visit the Authority will:

(A) Within 60 calendar days, issue a written preliminary report to the sponsor of findings of the site visit, any deficiencies that were found, and provide the sponsor with the opportunity to submit a plan of corrective action;

(i) A signed plan of correction must be received by the Authority within 30 calendar days from the date the preliminary report of findings was provided to the project sponsor;

(ii) The Authority shall determine if the written plan of correction is acceptable no later than 30 calendar days after receipt. If the plan of correction is not acceptable to the Authority, the Authority shall notify the project sponsor in writing and request that the plan of correction be modified and resubmitted no later than 10 business days from the date the letter of non-acceptance was mailed to the project sponsor;

(iii) The project sponsor shall correct all deficiencies within 30 calendar days from the date of correction provided by the Authority, unless an extension of time is requested from the Authority. A request for such an extension shall be submitted in writing and must accompany the plan of correction.

(iv) If the project sponsor does not come into compliance by the date of correction reflected on the approved plan of correction, the Authority may propose to suspend or terminate the project as defined under OAR 333-010-0820, Suspension or Termination of Project.

(B) Within 90 calendar days of receipt of a plan of correction, issue a final report to the sponsor; and

(C) If there are no corrections needed, the Authority will issue a final report within 180 calendar days.

(4) The Authority may also provide the sponsor with the opportunity to submit a corrective action plan to address any deficiencies found by the Authority during any project monitoring as described in section (1) of this rule. The Authority shall notify the sponsor in writing of the requirement to submit a plan of correction. The sponsor must submit, and the Authority must receive the plan of correction by the deadline set in the notification. All of the requirements and deadlines described in section (3) of this rule for corrective action plans apply to a project sponsor when directed to submit a corrective action plan under this section (4).

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0800
Dental Pilot Projects: Project Modifications

(1) Any modifications to an approved project shall be submitted in writing to program staff, except as specified in section (4) of this rule. All modifications require Authority approval. Modifications include, but are not limited to the following:

(a) Changes in selection criteria for trainees, supervisors, or employment/utilization sites;

(b) Addition of employment/utilization sites; and

(c) Changes in the scope of practice for trainees.

(2) Upon receipt of a request for a modification approval, the Authority will inform the project sponsor in writing on the timeline for review of the request and decision response deadline.

(3) If the Authority has convened an advisory committee for an approved project, the Authority may confer with the advisory committee regarding the proposed modification.

(4) Changes in project staff or instructors are not considered a modification and do not require prior approval by program staff, but shall be reported to the program staff within two weeks after the change occurs along with the curriculum vitae for the new project staff and instructors.

(5) The Authority may approve or deny a request for modification. A modification may be denied if:

(a) It does not demonstrate that the project can meet the minimum standards or other provisions in these rules;

(b) The modification would result in a substantial change to underlying purpose and scope of the pilot project as originally approved;

(c) As a result of the modification, the project would no longer demonstrate that each of the project’s trainees or employment/utilization sites shall provide services to the underserved populations identified in the application at a rate of at least 51 percent of the individuals served by the trainee or employment/utilization site on a quarterly basis; or

(d) The Authority has previously approved a similar project.

(6) Projects are not permitted to implement the proposed modification until approval has been rendered by the Authority.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0810
Dental Pilot Projects: Discontinuation or Completion of Project

(1) An approved project must notify the Authority in writing if it intends to discontinue its status as a Dental Pilot Project, at least 60 calendar days prior to discontinuation. Notification must include a closing report that includes, but is not limited to:

(a) The reasons for discontinuation as a pilot project;

(b) A summary of pilot project activities including the number of persons who entered the employment/utilization phase; and

(c) A description of the plan to inform trainees of the project’s discontinuation and that they are precluded from performing the skills authorized under the pilot project after discontinuation unless the provider type has been legalized by the State of Oregon.

(2) The project must obtain written acknowledgement from trainees regarding notification of the project’s discontinuation and preclusion from performing skills authorized under the pilot project after discontinuation, unless the provider type has been legalized and the trainee has met necessary licensure requirements.

(3) Project completion. A project sponsor must provide a full report of findings to the Authority within 180 calendar days of the completion of the project in a format prescribed by the Authority.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018

333-010-0820
Dental Pilot Projects: Suspension, Denial or Termination of Project

(1) A pilot project may be suspended, terminated, or denied if:

(a) A pilot project violates any provision of 2011 Oregon Laws, chapter 716;

(b) A pilot project violates any of these rules; or

(c) A pilot project fails to provide care that meets the applicable standard of care.

(2) Failure of a sponsor or anyone involved with an approved pilot project to cooperate with a reasonable request for records, interviews or a site visit is grounds for the Authority to suspend or terminate a project. Failure to cooperate includes, but is not limited to, failure to provide information or documents in a manner requested by the Authority or within the timeframe requested by the Authority.

(3) If the Authority determines that a dental pilot project has violated 2011 Oregon Laws, chapter 716, violated one or more of these rules, or failed to provide care that meets the applicable standard of care, the Authority may:

(a) Require the sponsor to implement an approved corrective action plan in accordance with OAR 333-010-0790, Authority Responsibilities; or

(b) Issue a Notice of Proposed Suspension or Notice of Proposed Termination in accordance with ORS 183.411 through 183.470.

(4) A sponsor who receives a Notice may request an informal meeting with the Authority. A request for an informal meeting does not toll the period for filing a timely request for a contested case hearing as described in section (5) of this rule.

(5) If the Authority issues a Notice of Proposed Suspension or Notice of Proposed Termination the sponsor is entitled to a contested case hearing as provided under ORS chapter 183. The sponsor has 30 calendar days to request a hearing.

(6) If the Authority terminates a dental pilot project, the order shall specify when, if ever, the sponsor may reapply for approval of a dental pilot project.

Statutory/Other Authority: 2011 OL Ch. 716
Statutes/Other Implemented: 2011 OL Ch. 716
History:
PH 29-2020, amend filed 04/29/2020, effective 05/01/2020
PH 277-2018, adopt filed 11/30/2018, effective 12/01/2018