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The Oregon Administrative Rules contain OARs filed through June 15, 2014
 
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OREGON HEALTH AUTHORITY,
PUBLIC HEALTH DIVISION

 

DIVISION 10

HEALTH PROMOTION AND CHRONIC DISEASE PREVENTION

Cancer Reporting Regulations

333-010-0000

Definitions

(1) "Active follow-up program" means a program for contacting a caregiver or cancer patient 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 reporting 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) "Cancer reporting facility" means a hospital or other health care facility in which cancer is diagnosed or treated and is also one of the following:

(a) A facility currently licensed as a hospital as defined under the provisions of ORS 442.015(13); or

(b) A facility currently licensed as an ambulatory surgical center as defined under ORS 442.015(3)(a).

(5) "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.

(6) “Central Registry Cancer Notification Form” means the form required for health care providers to report a case of reportable cancer or reportable non-malignant condition.

(7) "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.

(8) “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.

(9) “Date of diagnosis" means the date of initial diagnosis by a health care provider for the cancer being reported.

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

(11) "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 Facility Oncology Registry Data Standards Manual, 2011.

(12) “Health care provider” means any person whose professional license allows him/her to diagnose or treat cancer patients.

(13) "Health system cancer registry" means a cancer registry that includes all reportable cancer cases occurring in the population served by a health system, whether or not the cases are diagnosed or treated in the cancer reporting facility.

(14) "OSCaR" means the Oregon State Cancer Registry, Oregon's central cancer registry.

(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, and 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 cancer reporting 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, 2011.

(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.

Stat. Auth.: ORS 432.500, 432.510, 432.540
Stats. Implemented: ORS 432.510, 432.520, 432.540
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0010

General Authority

ORS 432.510 directs the Oregon Health Authority to “establish a uniform, statewide, population-based registry system for the collection of information determining the incidence of cancer and benign tumors of the brain and central nervous system and related data. The purpose of the registry shall be to provide information to design, target, monitor, facilitate, and evaluate efforts to reduce the burden of cancer and benign tumors among the residents of Oregon.” ORS 432.510, subsections (a) through (e) further specify that such efforts may include but are not limited to:

(1) Targeting populations in need of screening or other cancer control services;

(2) Supporting the operation of hospital registries and upgrading the care of cancer and benign tumors;

(3) Investigating suspected clusters;

(4) Conducting studies to identify cancer hazards; and

(5) Projecting the benefits or costs of alternative policies regarding the prevention or treatment of benign tumors or cancer.

Stat. Auth.: ORS 432.510
Stats. Implemented: ORS 432.510
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0020

Reporting Requirements for Cancer Reporting Facilities

This rule describes the specific requirements for cancer reporting facilities. Such facilities include inpatient facilities, outpatient facilities acting under the license of a hospital, ambulatory surgical centers, and privately owned treatment or diagnostic centers contracted to and acting as a department of a cancer reporting facility.

(1) Cancer reporting 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 and/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) Cancer reporting 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) Cancer reporting 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) Cancer reporting 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 cancer reporting facility.

(6) Cancer reporting 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 cancer reporting facilities.

(7) Cancer reporting 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 cancer reporting 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 registry. The central 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 registry to abstract and report cases have fulfilled their abstracting and reporting requirements under these rules.

(9) Upon application to OSCaR by a cancer reporting facility, OSCaR may grant to the facility an extension of time, not to exceed two years, in which to meet the reporting requirements. Such requests must be in writing and directed to the Medical Director of OSCaR. On request, the central registry staff shall provide technical assistance to facilities to meet the reporting requirements.

(10)(a) If cancer reports from a reporting 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, cancer reporting facilities will fulfill all reporting requirements.

(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.

Stat. Auth.: ORS 432.510, 432.520
Stats. Implemented: ORS 432.510, 432.520
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0030

Reporting Requirements for Health Care Providers

(1) Any health care provider 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 health care provider contact information, as specified on the Central Registry Cancer Notification Form. Copies of the Central Registry Cancer Notification Form will be available on the Oregon State Cancer Registry website: www.healthoregon.org/oscar.

(3) Health care providers 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 Registry Cancer Notification Form; or

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

(4) Health care providers need not report any case admitted to an Oregon reporting facility 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) Health care providers reporting cases of reportable cancer and reportable non-malignant conditions to a health system cancer registry have discharged their reporting responsibilities provided that the health system cancer registry reports those cases to OSCaR according to the requirements for cancer reporting facilities.

(6) If a health care provider fails to notify OSCaR of cases of reportable cancer and reportable non-malignant conditions according to the standards and format prescribed for health care providers, OSCaR may inform the health care provider in writing of the disparity between the health care provider's reporting performance and the reporting standards and consult with the health care provider regarding methods for bringing the health care provider'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 health care provider, or if OSCaR learns of an unreported case for which the health care provider has reporting responsibility but of which the central registry has not been notified by the health care provider, OSCaR may notify the health care provider of the missing information or case and the health care provider must, within 30 days, submit requested additional information to OSCaR. In the alternative, OSCaR may contact the health care provider and schedule a time to abstract the necessary data from the health care provider's records. The health care provider 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 health care provider 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 health care providers.

Stat. Auth.: ORS 432.510, 432.520
Stats. Implemented: ORS 432.510, 432.520
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0032

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 mutually agreed to by OSCaR and the clinical laboratory. 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.

Stat. Auth.: ORS 432.510, 432.520
Stats. Implemented: ORS 432.510, 432.520
Hist.: PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0035

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 the 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.

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500–432.900
Hist.: OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0040

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(5) directs the Oregon Health Authority to establish a quality control program for the data reported to the state registry. In order to assess these aspects of quality for cancer reporting, the central registry will institute a program of continuous quality improvement.

(1) The continuous quality improvement system must include, but is not limited to, coding edits, completeness audits or checks, reabstracting audits, and data analysis techniques to estimate data accuracy, validity, and reliability.

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

(3) The collection of cancer data from cancer reporting 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 cancer reporting 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 cancer reporting 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 cancer reporting 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 health care provider must submit a minimum of 95 percent of reportable cases to the central cancer registry within 180 days of the date of diagnosis.

Stat. Auth.: ORS 432.510
Stats. Implemented: ORS 432.510
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0050

Confidentiality and Access to Data

(1) All identifying information regarding individual patients, cancer reporting facilities, clinical laboratories, and health care providers 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) Cancer reporting facilities shall have access to confidential and privileged data on any case submitted by that facility. When a patient has been seen for care of a case of cancer by multiple cancer reporting facilities, OSCaR may share information on treatment and follow-up among the facilities, provided that all participating facilities have signed agreements with OSCaR to do so.

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

Stat. Auth.: ORS 432.510, 432.520
Stats. Implemented: ORS 432.530, 432.540
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0055

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) Facilitate 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; and

(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) & (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) Unless OSCaR determines it to be impracticable, OSCaR and/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 and/or the researcher must make a good faith effort to find the patient's current physician.

(c) 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.

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

(e) 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.

Stat. Auth.: ORS 432.510, 432.530, 432.540
Stats. Implemented: ORS 432.510, 432.530, 432.540
Hist.: OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0060

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 health care provider 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 cancer reporting 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.

Stat. Auth.: ORS 432.510, 432.520
Stats. Implemented: ORS 432.510, 432.520
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0070

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.

Stat. Auth.: ORS 432.510, 432.520
Stats. Implemented: ORS 432.510
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0080

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 registry staff must supplement the continuing education with one-on-one consultations to assist cancer reporting facilities and health care providers as needed in meeting the reporting requirements.

Stat. Auth.: ORS 432.510
Stats. Implemented: ORS 432.510
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; PH 13-2011, f. 12-28-11, cert. ef. 1-1-12

333-010-0090

Fees

OSCaR may establish fees, reasonably calculated, to reimburse for its actual cost in making OSCaR records and data available to researchers. Such costs include, but are not limited to, costs for computer programming; consultation; and for summarizing, compiling, analyzing, or tailoring records and data to a researchers' needs.

Stat. Auth.: ORS 432.560
Stats. Implemented: ORS 432.500 - 432.990
Hist.: OHD 11-1999, f. & cert. ef. 12-8-99

Breast and Cervical Cancer Program

333-010-0100

Description of the Breast and Cervical Cancer Program

The Breast and Cervical Cancer Program (BCCP) is a federal screening and early detection program administered by the Oregon Health Authority to provide screening and diagnostic services to eligible Oregonians statewide. The Breast and Cervical Cancer Program 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 333-010-0195 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: PH 9-2008, f. & cert. ef. 6-16-08; PH 1-2012, f. & cert. ef. 1-17-12

333-010-0105

Definitions

(1) "Ancillary provider" means a provider that performs services beyond the scope of an enrolling provider. Ancillary providers may include laboratories, imaging centers, surgeons and surgical facilities, and hospitals.

(2) "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 provider.

(3) "Approved medical services agreement" means the completed Breast and Cervical Cancer 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) "BCCP Provider Network" means the combination of all contracted BCCP providers, including enrolling and ancillary providers.

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

(8) "Breast and Cervical Cancer Program" means the program 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.

(9) "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.

(10) "Center" means the Center for Prevention and Health Promotion, the office within the Oregon Health Authority that administers the Breast and Cervical Cancer Program.

(11) "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.

(12) "Client" means a person of any age or gender who is enrolled in and receives screening or diagnostic services from the Breast and Cervical Cancer Program.

(13) "Enrolling provider" means a provider that enrolls a client into the Breast and Cervical Cancer Program, provides care coordination for the BCCP client and timely data submission to the BCCP.

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

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

(16) "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 BCCP clients.

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

(18) "Underinsured" means that insurance does not pay for preventive health exams that provide breast or cervical screening or diagnostic services, such as a mammogram or Pap smear, or that the deductible is $500 or more.

Stat. Auth.: ORS 413.042
Stats. Implemented: 413.042
Hist.: PH 9-2008, f. & cert. ef. 6-16-08; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 11-2011, f. & cert. ef. 10-27-11; PH 1-2012, f. & cert. ef. 1-17-12; PH 13-2014(Temp), f. & cert. ef. 4-22-14 thru 10-19-14

333-010-0110

Client Eligibility

(1) In order to be eligible for the BCCP a client must meet the following BCCP eligibility criteria:

(a) 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

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

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

(d) Meet one of the following criteria:

(A) Be a woman age 40 or over;

(B) Be a woman age 39 or under who is displaying symptoms that may indicate breast or cervical cancer; or

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

(2) For a client to be eligible under paragraphs (1)(d)(B) and (C) of this rule, the BCCP program must provide authorization for services to be rendered.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: PH 9-2008, f. & cert. ef. 6-16-08; PH 1-2012, f. & cert. ef. 1-17-12

333-010-0115

Client Enrollment

(1) Clients are determined eligible on a self-declared basis, when they submit a completed and signed BCCP enrollment form at the clinic site at the time of service, except as required by Client Eligibility, OAR 333-010-0110(2).

(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 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) BCCP 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: PH 9-2008, f. & cert. ef. 6-16-08; PH 1-2012, f. & cert. ef. 1-17-12

333-010-0120

Covered Services

(1) BCCP 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) The BCCP Program Manual includes a complete list of covered services.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 BCCP 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.

(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;

(b) Testing for sexually transmitted infections; or

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

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 BCCP 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 level. Providers must accommodate a client’s request for alternate formats.

(4) Access to Care. Services covered by BCCP 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 BCCP, 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 BCCP 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 provided 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.

(6) An enrolling provider must enroll and attempt to initiate breast screening services in addition to cervical services when a client is enrolled due to cervical symptoms as described in OAR 333-010-0110. All data must be submitted to the BCCP by the enrolling provider including required information about client history, original pelvic exam and Pap smear.

(7) An enrolling provider must enroll and attempt to initiate cervical screening services in addition to breast services when a client is enrolled due to breast symptoms as described in OAR 333-010-0110 except when the client is a man. Enrolling providers must submit all data to the BCCP including required information about client history, initial clinical breast exam and mammogram.

Stat. Auth.: ORS 413.042, 414.540
Stats. Implemented: ORS 413.042, 414.534, 414.536
Hist.: PH 9-2008, f. & cert. ef. 6-16-08; PH 1-2012, f. & cert. ef. 1-17-12

333-010-0135

Provider Enrollment

(1) This rule applies only to providers participating in BCCP 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 BCCP 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 BCCP 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) BCCP 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 BCCP from a BCCP representative before services are initiated.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 BCCP services.

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

(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, 9th Revision, Clinical Modification (ICD-9-CM) diagnosis codes and the most appropriate Current Procedural Terminology (CPT) codes as noted in the BCCP Program Manual. Claims including primary diagnosis codes that are not in the BCCP Program Manual will not be paid.

(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 BCCP must not seek payment from an eligible client, or from a financially responsible relative or representative of that individual, for any services covered by BCCP.

(a) A client may be billed for services that are not covered by BCCP. 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 BCCP are those outside of the scope of standard breast and cervical cancer screening and diagnosis, or those not included in the ICD-9 and CPT code lists provided in the BCCP Program Manual.

(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, where described in the claims section of the rules. A claim is considered a “valid claim” only when all required data is received by the BCCP.

(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 ICD-9-CM codes for breast and cervical screening or diagnostic testing as defined in the program manual.

(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 Cneter 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 BCCP 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 BCCP 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 the Enrollment Form, Breast Tracking Form and the Cervical Tracking Form, as defined by the program in the latest version of the BCCP Program Manual.

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

(4) If a provider terminates the medical services agreement data are still required to be submitted through the completion of each client’s cycle.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 12 months of the date of service.

(2) Errors causing rejection of any claim must be resolved within 12 months of the date of service. Claims older than 12 months 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 12 months 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 BCCP 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 BCCP and are billing for an eligible client.

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

(4) Center payments for BCCP 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: PH 9-2008, f. & cert. ef. 6-16-08; PH 13-2014(Temp), f. & cert. ef. 4-22-14 thru 10-19-14

333-010-0160

Requirements for Financial, Clinical and Other Records

(1) The Center is responsible for analyzing and monitoring the operation of BCCP 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 BCCP 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 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 Centermay 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 Centermay:

(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 BCCP.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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 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 Cneter 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 BCCP, 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042
Hist.: 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(1) and OAR 410-200-0400.

Stat. Auth.: ORS 413.042, 414.540
Stats. Implemented: ORS 414.534, 414.536
Hist.: PH 1-2012, f. & cert. ef. 1-17-12

WISEWOMAN Program

333-010-0200

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, a lifestyle intervention 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 to women with family incomes up to 250 percent of the Federal Poverty Level 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: 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) "Underinsured" means that a client's insurance does not pay for heart disease, stroke and diabetes screenings or services, such as cholesterol, triglyceride, A1C, and glucose testing and consultations.

(15) "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.

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

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 5-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; PH 11-2011, f. & cert. ef. 10-27-11; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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) Have an income based on family size that is at or below 250 percent of the FPL at the time of enrollment;

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

(3) Have no health insurance or is underinsured;

(4) Is a woman 40 to 64 years of age; and

(5) Is enrolled in the BCCP program.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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. The WW Program Manual, March 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.150
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0235

Covered Services

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

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

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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-9 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: 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, 9th Revision, Clinical Modification (ICD-9-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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: 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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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]

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042 & 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

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.

Stat. Auth.: ORS 413.042
Stats. Implemented: ORS 413.042 & 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09; PH 12-2014(Temp), f. & cert. ef. 4-18-14 thru 10-15-14

Tobacco Prevention and Education Program

333-010-0300

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 Oregon 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.

Stat. Auth.: ORS 431.834
Stats. Implemented: ORS 431.831 - 431.836
Hist.: HD 11-1997, f. & cert. ef. 9-12-97

333-010-0310

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.

Stat. Auth.: ORS 431.834
Stats. Implemented: ORS 431.831 - 431.836
Hist.: HD 11-1997, f. & cert. ef. 9-12-97

333-010-0320

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.

Stat. Auth.: ORS 431.834
Stats. Implemented: ORS 431.831 - 431.836
Hist.: HD 11-1997, f. & cert. ef. 9-12-97

333-010-0330

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.

Stat. Auth.: ORS 431.834
Stats. Implemented: ORS 431.831 - 431.836
Hist.: HD 11-1997, f. & cert. ef. 9-12-97

333-010-0350

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 Oregon Administrative Rules, 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.

Stat. Auth.: ORS 431.834
Stats. Implemented: ORS 431.831 - 431.836
Hist.: HD 11-1997, f. & cert. ef. 9-12-97

333-010-0360

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 Oregon Administrative Rules, 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 Oregon Administrative Rules, 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.

Stat. Auth.: ORS 431.834
Stats. Implemented: ORS 431.831 - 431.836
Hist.: HD 11-1997, f. & cert. ef. 9-12-97

333-010-0370

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.

Stat. Auth.: ORS 431.834
Stats. Implemented: ORS 431.831 - 431.836
Hist.: HD 11-1997, f. & cert. ef. 9-12-97

Dental Pilot Projects

333-010-0400

Description of Dental Pilot Projects

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 oral health status of Oregonians is poor and the most vulnerable are those with the least access to services. OAR 333-010-0400 through 333-010-0470 provides administrative guidance to the required content of Dental Pilot Project applications, process for review, approval and monitoring of Dental Pilot Projects, and steps to terminate or conclude a Dental Pilot Project.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0405

Definitions

For purposes of OAR 333-010-0400 through 333-010-0470, the following definitions apply:

(1) “Authority” means the Oregon Health Authority.

(2) “Clinical phase” means instructor supervised experience with a patient during which a trainee applies knowledge presented by an instructor.

(3) “Didactic phase” means an organized body of knowledge presented by an instructor.

(4) “Director” means the Public Health Director within the Oregon Health Authority, or his or her designee.

(5) “Employment/Utilization Phase” means ongoing application of didactic and clinical knowledge and skills in an employment setting under the supervision of a supervisor.

(6) “Employment/Utilization Site” means a health facility, any clinical setting where health care services are provided, and the facilities or programs described in ORS 680.205(1).

(7) “Instructor” means a person qualified to practice or teach the knowledge or skills a trainee is to learn.

(a) “Clinical instructor” is a person who is certified or licensed in the field for which clinical instruction is occurring.

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

(8) “Program” means the Dental Pilot Projects program administered by the Authority.

(9) “Program staff” means the staff of the Authority with responsibility for the program.

(10) “Project” means a Dental Pilot Project approved by the director or delegate.

(11) “Project director” means the individual designated by the sponsor to have responsibilities for the conduct of the project staff, instructors, supervisors, and trainees.

(12) “Reviewer” means an individual designated by program staff to review and comment on all or portions of a project application.

(13) “Sponsor” means an entity putting forth an application for a dental pilot project.

(14) “Training program” means an organized educational program that includes at least a didactic phase, clinical phase, and usually an employment/utilization phase.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0410

Minimum Standards

A dental pilot project shall:

(1) Provide for patient safety as follows:

(a) Provide treatment which does not expose a patient to risk of harm when equivalent or better treatment with less risk to the patient is available;

(b) Seek consultation whenever the welfare of a patient would be safeguarded or advanced by having recourse to those who have special skills, knowledge and experience; (c) Provide or arrange for emergency treatment for a patient currently receiving treatment;

(d) Comply with ORS 453.605 to 453.755 or rules adopted pursuant thereto relating to the use of x-ray machines;

(e) Not attempt to perform procedures which the trainee is not capable of performing due to physical or mental disability; and

(f) Comply with the infection control procedures in OAR 818-012-0040.

(2) Provide appropriately qualified instructors to prepare trainees;

(3) Assure that trainees have achieved a minimal level of competence before they enter the employment/utilization phase;

(4) Inform trainees in writing that there is no assurance of a future change in law or regulations to legalize their role;

(5) Demonstrate that the project has sufficient staff to monitor trainee performance and to monitor trainee supervision during the employment/utilization phase;

(6) Demonstrate the feasibility of achieving the project objectives;

(7) Comply with the requirements of the Dental Pilot Projects statute, Oregon Laws 2011, chapter 716 and rules adopted thereunder;

(8) Evaluate quality of care, access, cost, workforce, and efficacy;

(9) 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.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0415

Application Procedure

(1) A sponsor may submit an application for a dental pilot project on a form prescribed by the Authority.

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

(3) An application must include, but is not limited to the following information:

(a) Sponsors:

(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, or community hospital or clinic;

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

(D) The funding sources for the project; and

(E) Documentation of liability insurance relevant to services provided by trainees.

(b) Trainee information:

(A) The criteria that will be used to select trainees; and

(B) The number of proposed trainees.

(c) Instructor/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

(E) The criteria used to select an employment/utilization site.

(d) Costs:

(A) The average cost of preparing a trainee, including but not limited to the cost information related to instruction, instructional materials and equipment, space for conducting didactic and clinical phases, and other pertinent costs;

(B) The predicted average cost per patient visit for the care rendered by a trainee; and

(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, 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 capitol costs associated with the project; and

(v) Travel required for implementing and monitoring the project.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0420

Trainees

(1) A dental pilot project must have a plan to inform trainees of their responsibilities and limitations under Oregon Laws 2011, chapter 716 and these rules.

(2) A project must provide notice to program staff within 14 days of a trainee entering the employment/utilization phase. The notice shall include, but is not limited to the following:

(a) Name, work address and telephone number of the trainee; and

(b) Name, work address, telephone number and license number of the supervisor.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0425

Instructor and Supervisor Information

A dental pilot project must have:

(1) Instructors:

(a) A number and distribution of instructors sufficient to meet project objectives; and

(b) Instructors with current knowledge and skill in topics they will teach.

(2) A plan to orient supervisors to their roles and responsibilities.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0430

Curriculum

A sponsor of a dental pilot project must have a curriculum plan that includes but is not limited to a description of:

(1) The level of competence the trainee shall have before entering the employment/utilization phase of the project;

(2) The instructional content required to meet the level of competence;

(3) The skills trainees are to learn;

(4) The methodology utilized in the didactic and clinical phases;

(5) The evaluation process used to determine when trainees have achieved the level of competence; and

(6) The hours and months of the time required to complete the didactic and clinical phases.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0435

Evaluation and Monitoring

(1) Evaluation Plan. A sponsor of a dental pilot project must have an evaluation plan that includes, but is not limited to the following:

(a) A description of the baseline data and information collected about the availability or provision of oral health care delivery, or both, prior to utilization of the trainee;

(b) A description of baseline data and information to be collected about trainee performance, acceptance among patient and community, and cost effectiveness;

(c) A description of methodology to be used in collecting and analyzing the data about trainee performance, acceptance, and cost effectiveness; and

(d) A provision for reviewing and modifying objectives and methodology at least annually.

(2) Monitoring Plan. A sponsor of a dental pilot project must have a monitoring plan that ensures at least quarterly monitoring and describes how the sponsor will monitor and ensure:

(a) Patient safety;

(b) Trainee competency;

(c) Supervisor fulfillment of role and responsibilities; and

(d) Employment/utilization site compliance.

(3) Data. A sponsor’s evaluation and monitoring plans must describe:

(a) How data will be collected;

(b) How data will be monitored for completeness; and

(c) How data will be protected and secured.

(4) A sponsor must permit project staff or their designees to visit each employment/utilization site at least monthly during the first six month period and at least quarterly thereafter.

(5) A sponsor must provide a report of information requested by the program in a format and timeframe requested.

(6) A sponsor must report adverse events to the program the day they occur.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0440

Informed Consent

(1) A sponsor must ensure that informed consent for treatment is obtained from each patient or a person legally authorized to consent to treatment on behalf of the patient.

(2) A sponsor must submit an informed consent form and any accompanying information to program staff for review. Informed consent must include but is not limited to the following:

(a) An explanation of the role and status of the trainee, including the ready availability of the trainee’s supervisor for consultation;

(b) Assurance that the patient can refuse care from a trainee without penalty for such a request; and

(c) Identification that consenting to treatment by a trainee does not constitute assumption of risk by the patient.

(3) Informed consent shall be provided in a language in which the patient is fluent.

(4) Dental pilot project staff or trainees must document informed consent in the patient record prior to providing care to the patient.

(5) Informed consent needs to be obtained specifically for those tasks, services, or functions to be provided by a pilot project trainee.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0445

Application Review Process

(1) The program staff shall review an application to determine if it is complete within 45 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, the program shall notify the applicant of the information that is missing, and shall allow the applicant 15 days to submit the missing information.

(b) If an applicant does not submit the missing information within the timeframe specified in the notice 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 program may have individuals outside the program review applications but no individual who has contributed to or helped prepare an application will be permitted to do a review.

(4) Program staff may request additional information from an applicant during the review process.

(5) Once project staff have completed an application review a Notice of Intent to approve or deny an application will be provided to the applicant and the Notice and application will be posted for public comment for a period of 10 business days. The Notice will be sent to interested parties.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0450

Project Approval

(1) Once the public comment period described in OAR 333-010-0445(5) has closed the director or his or her designee shall grant or deny approval of a pilot project applicant within 30 calendar days of receiving the application from the program.

(2) If the director grants approval, he or she will specify the length of time the project can operate.

(3) The director’s decision shall be transmitted in writing to the applicant.

(4) A sponsor whose project has been denied may not submit a new application within six months from the date the director denied the application.

(5) The program staff shall notify the Oregon Board of Dentistry when a project is approved.

(6) The director or his or her designee may extend the length of time a project can operate at his or her discretion.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0455

Program Responsibilities

(1) Project evaluation. Program staff shall evaluate approved projects and the evaluation shall include but is not limited to:

(a) Periodically requesting written information from the project, at least annually to ascertain the progress of the project in meeting its stated objectives and in complying with program statutes and regulations; and

(b) Periodic, but at least annual, site visits to project offices, locations, or both, where trainees are being prepared or utilized.

(2) 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; and

(C) Interviews with project participants and recipients of care.

(b) An interdisciplinary team composed of representatives of the dental boards, professional organizations, and other state regulatory bodies may be invited to participate in the site visit.

(c) Written notification of the date, purpose, and principal members of the site visit team shall be sent to the project director at least 14 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) A report of findings and an indication of pass or fail for site visits shall be prepared by program staff and provided to the project director in written format within 60 calendar days following a site visit.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0460

Modifications

(1) Any modifications or additions to an approved project shall be submitted in writing to program staff. Modifications include, but are not limited to the following:

(a) Changes in the scope or nature of the project. Changes in the scope or nature of the project require program staff approval;

(b) Changes in selection criteria for trainees, supervisors, or employment/utilization sites; and

(c) Changes in project staff or instructors.

(2) Changes in project staff or instructors 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.

(3) All other modifications require program staff approval prior to implementation.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0465

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 role has been legalized.

(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 role has been legalized and the trainee has met necessary licensure requirements.

(3) The project must inform the Oregon Board of Dentistry that the project is completed and provide a list of trainee names associated with the project at least 14 calendar days prior to discontinuation.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

333-010-0470

Suspension or Termination of Project

(1) A pilot project may be suspended or terminated during the term of approval for violation of 2011 Oregon Laws, chapter 716 or any of these rules.

(2) If the Authority determines that a dental pilot project is in violation of 2011 Oregon Laws, chapter 716 or these rules, the Authority may issue a Notice of Proposed Suspension or Notice of Proposed Termination in accordance with ORS 183.411 through 183.470. A sponsor who receives a Notice may request an informal meeting with the director and program staff. A request for an informal meeting does not toll the time period for requesting a hearing as described in section (3) of this rule.

(3) 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 days to request a hearing.

(4) 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.

Stat. Auth.: 2011 OL Ch. 716
Stats. Implemented: 2011 OL Ch. 716
Hist.: PH 5-2013, f. & cert. ef. 2-4-13

Childhood Diabetes Database

333-010-0600

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 the 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.]

Stat. Auth.: ORS 444.300
Stats. Implemented: ORS 444.300-444.330
Hist.: PH 6-2007, f. & cert. ef. 4-13-07

333-010-0610

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.

Stat. Auth.: ORS 444.300
Stats. Implemented: ORS 444.300-444.330
Hist.: PH 6-2007, f. & cert. ef. 4-13-07

333-010-0620

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).

Stat. Auth.: ORS 444.300
Stats. Implemented: ORS 444.300-444.330
Hist.: PH 6-2007, f. & cert. ef. 4-13-07

333-010-0630

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.

Stat. Auth.: ORS 444.300
Stats. Implemented: ORS 444.300-444.330
Hist.: PH 6-2007, f. & cert. ef. 4-13-07

333-010-0640

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

Stat. Auth.: ORS 444.300
Stats. Implemented: ORS 444.300-444.330
Hist.: PH 6-2007, f. & cert. ef. 4-13-07

333-010-0650

Research Studies

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

(a) Obtain approval from the 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.

Stat. Auth.: ORS 444.300
Stats. Implemented: ORS 444.300-444.330
Hist.: PH 6-2007, f. & cert. ef. 4-13-07

333-010-0660

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.

Stat. Auth.: ORS 444.300
Stats. Implemented: ORS 444.300-444.330
Hist.: PH 6-2007, f. & cert. ef. 4-13-07

The official copy of an Oregon Administrative Rule is contained in the Administrative Order filed at the Archives Division, 800 Summer St. NE, Salem, Oregon 97310. Any discrepancies with the published version are satisfied in favor of the Administrative Order. The Oregon Administrative Rules and the Oregon Bulletin are copyrighted by the Oregon Secretary of State. Terms and Conditions of Use

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