The Oregon Administrative Rules contain OARs filed through January 15, 2010

DEPARTMENT OF HUMAN SERVICES, PUBLIC HEALTH DIVISION

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 442.015(14)(a) or (c) including but not limited to routine admission to the hospital, admission to the Emergency Room, or receiving services in an out-patient clinic.

(3) "Cancer reporting facility" means a hospital or other facility in which cancer is diagnosed or treated and is also one of the following:

(a) A facility currently licensed as a health care facility under the provisions of ORS 442.015(14)(a); or

(b) An ambulatory surgical center licensed under ORS 442.015(14)(c).

(4) "Case" means a reportable cancer in an individual who is either a resident of Oregon, regardless of where the individual was treated or diagnosed, or a nonresident diagnosed or treated in Oregon.

(5) "Central cancer registry" means the Oregon 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) "Certified tumor registrar" means an individual who passes the certification examination and is currently certified by the National Board for Certification of Registrars.

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

(8) "Division" means the Health Division of the Department of Human Services.

(9) "First course of therapy" means the first cancer directed therapy, including all modalities, provided to a reportable case, as defined in the American College of Surgeons Commission on Cancer Registry Operating and Data System's Manual, 1996.

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

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

(12) "Practitioner" means any person whose professional license allows him/her to diagnose or treat cancer patients.

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

(14) "Reportable cancer" means all malignant neoplasms including carcinoma in situ, except basal and squamous cell carcinoma of the skin, and carcinoma in situ of the cervix uteri diagnosed on or after January 1, 1996. The International Classification of Diseases, 9th Revision, Clinical Modification, (ICD-9-CM), Third Edition codes for reportable cancers are: 140-208.9, 230-233.0, and 233.2-234.9.

(15) "Special study" means a Division-sponsored project which explores a particular facet of cancer incidence, morbidity, or mortality including, but not limited to, exploring a hypothesis of disease risk or treatment options authorized under ORS 432.500.

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98

333-010-0010

General Authority

According to ORS 432.500-432.990, the Health Division shall establish a uniform, statewide, population-based cancer registry system for the collection of information determining the incidence of cancer 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 in Oregon.

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96

333-010-0020

Reporting Requirements for Cancer Reporting Facilities

This section 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 the central cancer registry each case of reportable cancer, as defined in 333-010-0000(2), in patients admitted for diagnosis and/or any part of the first course of therapy for that cancer.

(2) Cancer reporting facilities shall report the required data items for each case to the central cancer registry. Required data items are available through OSCaR. Codes for each data item shall follow the recommendations of the American College of Surgeons Commission on Cancer and are further defined by the North American Association of Central Cancer Registries (NAACCR). Copies of the NAACCR Standards for Data Reporting are available upon request from the Oregon State Cancer Registry, Oregon Health Division, 800 NE Oregon Street, Portland, OR 97232.

(3) Cancer reporting facilities shall report data to the central cancer registry as stipulated in 333-010-0020(2) within 180 days of the date the case first receives cancer diagnostic or treatment services at the facility.

(4) Cancer reporting facilities with an active follow-up program shall annually report vital status, date of last patient contact, and, if available, cancer status, to the central cancer registry.

(5) Cancer reporting facilities shall report their cancer cases and any follow-up information to the central cancer registry in the electronic data exchange format and codes, Record Type A: Case Abstract, as specified by NAACCR.

(6) Cancer reporting facilities reporting cases to a health system cancer registry have discharged their reporting responsibilities provided that the health system registry reports those cases to the Division according to the requirements for cancer reporting facilities.

(7) Cancer reporting facilities may elect to:

(a) Allow the central cancer registry staff to do their cancer data collection. They may do so by authorizing the central cancer registry to identify and report their cancer cases. The reporting facilities shall reimburse the Division for these reporting services; or

(b) Contract with a private vendor or contractor to report cases to the Division as outlined above in 333-010-0020(2).

(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 reportable cases 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 the Division by a cancer reporting facility, the Division shall grant to the facility an extension of time, not to exceed two years, in which to meet the reporting requirements. Such requests shall 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, the Division shall inform the facility in writing of the disparity between the facility's reports and the reporting standards. The Division will then consult with the facility regarding its options for meeting the reporting standards, as defined in 333-010-0020(2). Options shall include, but are not limited to:

(A) Further consultation and training;

(B) Reference to contractors for reporting services;

(C) Provision, at cost, of reporting services by the Division. 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, the Division may activate its reporting service for the facility. When activated, the Division 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 the Division or its authorized representative for the cost of obtaining and reporting the information.

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98

333-010-0030

Reporting Requirements for Practitioners

This section describes the reporting requirements for practitioners. Statute ORS 432.500-432.990 establishes a dual reporting responsibility for cancer cases; one is for cancer reporting facilities and the other for practitioners. Practitioners need not report any case admitted to an Oregon reporting facility for the purpose of a cancer diagnosis or for all or any part of the first course of therapy providing that the admission to the facility occurs within 180 days of diagnosis. The practitioner reporting requirement is fulfilled by filing a Practitioner Cancer Notification Form or equivalent, as described in 333-010-0030(3), and by providing access to additional data, if necessary, as described in 333-010-0030(7).

(1) Any practitioner diagnosing a reportable case of cancer, as defined in 333-001-0000, must notify the central cancer registry of each such case within 180 days of the diagnosis of the case.

(2) Data items required for reporting a case include patient name, address, gender, birth date, primary site and type of cancer, date of diagnosis, and the name of the diagnosing practitioner.

(3) Practitioners may elect any of the following options to comply with the notification requirement:

(a) completion and submission of the Practitioner Cancer Notification Form. Copies of this form are available at the Oregon State Cancer Registry, Oregon Health Division, 800 NE Oregon Street, Portland, Oregon 97232.

(b) A written communication containing the information required by notification of the Practitioner Cancer Notification Form and directed to the Medical Director, Oregon State Cancer Registry.

(c) An electronic communication containing the information required by the Practitioner Cancer Notification Form and directed to the Medical Director, Oregon State Cancer Registry, at a confidential electronic mailbox established by the Division, or

(d) A FAX containing the information required by the Practitioner Cancer Notification Form and directed to the Medical Director of the Oregon State Cancer Registry at a confidential receiver established by the Division.

(4) Practitioners need not report any case admitted to an Oregon reporting facility for:

(a) A cancer diagnosis; or

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

(5) Practitioners reporting cases to a health system cancer registry have discharged their reporting responsibilities provided that the health system cancer registry reports those cases to the Division according to the requirements for cancer reporting facilities.

(6) If a practitioner fails to notify the central registry of reportable cases according to the standards and format prescribed for practitioners, the Division shall inform the practitioner in writing of the disparity between the practitioner's reporting performance and the reporting standards. The Division will consult with the practitioner regarding methods for bringing the practitioner's reporting performance into compliance with the reporting standards.

(7) If the Division does not receive information from another source completing the information required for a reportable case submitted by a practitioner, or if the Division learns of an unreported case for which the practitioner has reporting responsibility but of which the central registry has not been notified by the practitioner, the Division will contact the practitioner to schedule a time to abstract the necessary data from the practitioner's records. The practitioner shall provide access to those portions of a patient's medical record which provide data for the items specified in the list of OSCaR Reportable Data Items.

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

[ED. NOTE: Appendices referenced are available from the agency.]

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98

333-010-0035

Patient Notification Requirement

This section describes the requirements for notifying patients that information about them has been reported to OSCaR.

(1) Responsibility for notifying patients.

(a) Each person reported to the Oregon State Cancer Registry shall be informed that information about them has been included in the Registry. In the absence of extenuating circumstances, this notification shall occur within one month of the report being received by OSCaR.

(b) OSCaR shall assume the responsibility for notifying the patient unless the facility or practitioner notifies OSCaR that they will routinely take on the notification responsibility of all patients themselves. OSCaR shall reconfirm annually that the facility or practitioner wants to continue to assume the responsibility for notification of all patients.

(c) If the facility or practitioner elects to inform the patient themselves, they shall choose one of the following options:

(A) The facility or practitioner may elect to have OSCaR provide patient notification information to the facility or practitioner for forwarding on to the patient;

(B) the facility or practitioner may elect to develop their own patient notification materials; or

(C) The facility or practitioner may arrange with a third party to carry out the notification process. The facility or practitioner shall: inform OSCaR of the name of the third party that will be carrying out the patient notification requirements, and specify how the third party will know to inform the patient. If either option (B) or (C) is elected, the facility or practitioner shall allow OSCaR to review and approve the materials to ensure that they meet the requirements for information outlined below in 333-010-0035(2).

(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 Division;

(b) That information reported to the Division includes: the type and characteristics of the cancer; details of the diagnosis; the patient's name, address, age, and sex; and the treatment given;

(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 the patient's name cannot 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 consult with the patient's physician regarding participation in a research project, unless the patient specifies to OSCaR either of the following: that their name never be released for any research purpose; or that researcher may contact them directly about participation in research projects.

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98

333-010-0040

Quality Standards

The usefulness of central registry data is directly dependent upon the accuracy, completeness, and timeliness of the data available in its database. ORS 432.500-432.990 directs the Division 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 shall include, but is not limited to, coding edits, completeness audits or checks, reabstracting audits, and statistical mechanisms to estimate data accuracy, validity, and reliability.

(2) For the purpose of assuring the accuracy and completeness of reported data, the Division shall have the right to periodically review all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer or the medical status of any identified cancer patient. The central registry will provide advance notification of a minimum of 30 days, to allow for the reporting sources to prepare records for review.

(3) The collection of cancer data from cancer reporting facilities, including data collection performed by the central cancer registry staff, shall 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 reporting facility with the information in the facility's medical record shall not be less than 95% for those data items identified in the OSCaR Reportable Data Items list as quality control items.

(6) A cancer reporting facility must submit 98% 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 therapy provided in that facility, whichever is later.

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

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96

333-010-0050

Confidentiality and Access to Data

(1) All identifying information regarding individual patients, cancer reporting facilities, and practitioners reported pursuant to OAR 333-010-0020 and ORS 432.500-432.990 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 the central cancer registry shall be stored in secure locations, shall be used solely for the purposes stated in ORS 432.500-432.990 and shall not be further disclosed unless required by law, with the following exceptions:

(a) When the Division has entered into reciprocal cooperative agreements with other states to exchange information on resident cases, as provided for in ORS 432.500-432.990. Such agreements shall 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, the Division shall 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 Division elects to contract with another agency for performance of a registry function the Division 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 333-010-0050(1). Before entering into any contract with another agency the Division shall determine the agency has comparable confidentiality protections; and

(d) When the Division 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, the Division may share information on treatment and follow-up among the facilities, provided that all participating facilities have signed agreements with the Division to do so.

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

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96; OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98

333-010-0055

Research Studies

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

(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 333-010-0010 of ORS 432.500-432.990;

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

(c) Approve the researcher's submitted protocol and procedures for: identifying patients to be contacted; protecting against inadvertent disclosure of confidential and privileged data; providing secure conditions to use and store the data; assuring that the data will only be used for the purposes of the study; and 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) Require that the proposed research be reviewed and approved by the body used by the Division as the Committee for the Protection of Human Research Subjects and established in accordance with 45 C.F.R. 46;

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

(g) Determine whether the research methodology has been reviewed for scientific excellence by a nationally recognized peer review group and, if it is determined that no such review has taken place, the Division shall convene an ad hoc peer review subcommittee of the advisory committee containing appropriately qualified scientists to perform a peer review of the research. The central registry shall not release confidential and privileged information to the researcher unless and until the proposed research is judged to be scientifically meritorious by the peer review group.

(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 be contacted regarding research studies.

(a) Before disclosing confidential patient information to a researcher, the Division shall:

(A) Determine whether any of the patients identified have previously informed the OSCaR that information regarding their cancer may not be disclosed under any circumstances, as described in 333-010-0035(2)(f). Such patients will be excluded from those provided to the researcher.

(B) For those patients to be contacted, determine whether they have previously informed OSCaR that they wish to be contacted about their participation in research programs directly by the researcher, or after consulting with the patient's treating physician as described in 333-010-0035(2)(f).

(b) For those patients who have indicated that researchers may contact them directly, the researcher shall make a good faith effort to identify and contact the patient's current treating physician to inform them of the study prior to any contact with a patient.

(c) In attempting to consult with the patient's physician prior to contacting the patient, the researcher shall first attempt to contact the patient's treating physician of record. In situations where the treating physician of record is no longer the patient's physician, the researcher shall make a good faith effort to find the patient's current physician. This effort would include determining if the treating physician had record of a referral physician, contacting other physicians in the patient's OSCaR record, and contacting any health system cancer registry that might contain additional physician information. Only in the case where no current physician of record could be identified would patient contact without prior physician contact be initiated.

(d) The contacted physician shall be informed of the study and of the identity of the eligible patient. Within three weeks that physician shall do one of the following:

(A) Contact the patient and determine the patient's interest in participating in the study. If the physician chooses this option, the physician must inform the researcher of the patient's decision within one week; or

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

(C) 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 would be under no obligation to disclose the specifics of the medical, psychological or social situation. When the presence of such situations are identified by the patient's treating physician, the researcher shall not attempt to contact the patient. However, a researcher may recontact the physician at a future time to determine whether or not the situation still exists.

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

(f) 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 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: OHD 7-1998, f. 7-14-98, cert. ef. 8-1-98

333-010-0060

Special Studies

(1) From time to time, the Division may elect to conduct special studies of cancer mortality and morbidity. The Division is specifically authorized to obtain any information which applies to a patient's cancer and which may be found in the medical record of the patient under ORS 432.500-432.990. Upon request, the practitioner or health care facility shall provide the requested information to the central cancer registry or provide the central cancer registry personnel access to the relevant portions of the medical records.

(2) If the Division seeks additional data on cancer cases which may be contained in a practitioner's medical records, for the conduct of a special study, the Division shall make the request of the practitioner. If asked, the Division shall provide the request in writing. Cancer registry personnel may obtain additional information which applies to a patient's cancer and which may be in the patient's medical record. The record holder may either provide the requested information to the cancer registry personnel or provide the cancer registry personnel access to the relevant portions of the patient's medical record. Neither the Division nor the record holder shall bill the other for the cost of providing or obtaining this information.

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96

333-010-0070

Advisory Committee

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

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96

333-010-0080

Training and Consultation

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

Stat. Auth.: ORS 432.500
Stats. Implemented: ORS 432.500 - 432.990
Hist.: HD 2-1996, f. & cert. ef. 2-29-96

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 Department of Human Services 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. These rules (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 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

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 Office of Family Health (OFH) 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 Office of Family Health.

(4) “BCCM” means the Breast and Cervical Cancer Medical Program. ORS 414.534, 414.536.

(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) “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 Office of Family Health within the Department of Human Services.

(8) “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.

(9) “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.

(10) “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.

(11) “DHS” means the Department of Human Services.

(12) “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.

(13) “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.

(14) “HIPAA” means the Health Insurance Portability and Accountability Act.

(15) “OFH” means the Office of Family Health, the office within the Department of Human Services that administers the Breast and Cervical Cancer Program.

(16) “Service provider” or “provider” means a licensed health care provider operating within a scope of practice, who is authorized by OFH 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 OFH 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 409.050
Stats. Implemented: 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

333-010-0110

Client Eligibility

Clients must meet the following BCCP eligibility criteria:

(1) The client’s income based on family size is at or below 250 percent of the Federal Poverty Level at the time of enrollment; and

(2) The client resides or declares an intent to reside in Oregon; and

(3) The client has no health insurance or is underinsured; and

(4) The client is a woman age 40 or over; or

(5) The client is a woman age 39 or below that is displaying symptoms that may indicate breast cancer, or is a man of any age that is displaying symptoms that may indicate breast cancer.

(6) Pre-authorization from the BCCP is required to determine eligibility for this population.

(7) Symptoms include:

(a) A persistent suspicious mass demonstrated over 2 Clinical Breast Exams (CBEs) at least a menstrual cycle apart; or

(b) An initial CBE demonstrating one or more of the following: bloody/serous nipple discharge, nipple scaliness, skin dimpling or retraction, or a mammogram or ultrasound that is “suspicious for malignancy”, as determined by a qualified medical professional.

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

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.

(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 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

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 409.050
Stats. Implemented: ORS 409.010
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 409.050
Stats. Implemented: ORS 409.010
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 diagnosed with breast or cervical cancer, including cervical intraepithelial neoplasia (CIN) II or III, shall be screened to determine eligibility for the BCCM 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:

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

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

(8) An enrolling provider must enroll and attempt to initiate breast screening services in addition to cervical services when a client is enrolled due to breast 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.

(9) An enrolling provider must enroll and attempt to initiate cervical screening services in addition to breast services when a client is enrolled due to cervical 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 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

333-010-0135

Provider Enrollment

(1) This rule applies only to providers participating in BCCP through an approved provider agreement with OFH.

(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 DHS 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 OFH.

(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), OFH must be notified in writing within 30 days of the change. Failure to notify OFH 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 OFH 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 OFH 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 DHS, 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 OFH 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 409.050
Stats. Implemented: ORS 409.010
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 OFH 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 OFH.

(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 OFH:

(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 OFH.

(11) A provider who, after having been previously warned in writing by DHS 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 OFH 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 409.050
Stats. Implemented: ORS 409.010
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 409.050
Stats. Implemented: ORS 409.010
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 OFH 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 OFH. The error must be confirmed by OFH.

(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 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

333-010-0155

Payment

(1) OFH 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 the Medicare reimbursement rate for BCCP approved CPT codes, on a fee-for-service basis.

(4) OFH payments for BCCP provider services, unless in error, constitute payment in full.

(5) OFH 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 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

333-010-0160

Requirements for Financial, Clinical and Other Records

(1) OFH 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 OFH, DHS, 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 OFH, 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 DHS;

(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 DHS 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 DHS, or to sanctions.

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010
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 OFH 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 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

333-010-0170

Denial or Recovery of Reimbursement Resulting from Review or Audit

(1) OFH’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 409.050
Stats. Implemented: ORS 409.010
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 OFH determines that an overpayment has been made to a provider, the amount of overpayment is subject to recovery:

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

(b) After OFH 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 OFH 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 OFH’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 OFH;

(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) OFH 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 OFH’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 OFH 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 OFH:

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

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

(6) OFH 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 OFH.

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

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

(b) Pursue civil action to recover the overpayment.

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

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

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

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010
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 OFH, 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 OFH 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 OFH;

(v) Submission of any claim for payment for which payment has already been made by OFH; 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, OFH may suspend or terminate the provider who is responsible for the violation.

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

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010
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 OFH. There are two levels of appeal. Level 1 is a reconsideration on a claim. Level 2 is a contested case hearing.

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

333-010-0190

Provider Appeals (Level 1) -- Claims Reconsideration

A provider disputing OFH’s claim decision may request reconsideration. The provider must submit the request in writing to OFH. The request must include the reason for the dispute, and any information pertinent to the outcome of the dispute. OFH 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 409.050
Stats. Implemented: ORS 409.010
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 409.050
Stats. Implemented: ORS 409.010
Hist.: PH 9-2008, f. & cert. ef. 6-16-08

WISEWOMAN Program

333-010-0200

Description of the WISEWOMAN Program

The WISEWOMAN (WW) Program is a federal program, administered by the Department of Human Services, 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 409.050
Stats. Implemented: ORS 409.010, 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 Office of Family Health (OFH) 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 OFH, has been assigned a BCCP/WW Program agency number, and performs services beyond the scope of an enrolled 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 Office of Family Health.

(4) “BCCP” means the Oregon Breast and Cervical Cancer Program.

(5) “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.

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

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

(8) “DHS” means the Department of Human Services.

(9) “Enrolled 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 OFH, has been assigned a BCCP/WW Program agency number, and provides screening, services, or care coordination for WW Program clients.

(10) “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.

(11) “HIPAA” means the Health Insurance Portability and Accountability Act.

(12) “OFH” means the Office of Family Health, within DHS, Public Health Division.

(13) “Site number” means the administrative number assigned to the family planning service provider by OFH 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 (WW) 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 OFH.

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

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0210

Client Eligibility

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

(1) 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 409.050
Stats. Implemented: ORS 409.010, 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 OFH or her enrolled provider in writing of such disenrollment and may be responsible for the payment of services received from her provider.

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0220

Provider Enrollment

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

(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 DHS or the federal government is not eligible for enrollment.

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

(6) If OFH 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 enrolled or ancillary provider may not offer services to a client prior to receiving information from an OFH WW Program representative about administering the WW Program.

(8) An enrolled provider or ancillary provider shall notify OFH 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 enrolled provider or an ancillary provider who has not furnished such notification may be recovered by OFH.

(9) An enrolled provider or an ancillary provider shall notify OFH 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 enrolled provider or an ancillary provider may terminate enrollment at any time by sending a written termination notice to OFH, 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 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0225

Standards of Care for WISEWOMAN Program Screening and Services

An enrolled 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 covered by the WW Program without cost to eligible clients;

(5) Refer clients with abnormal or ALERT (please see values listed in section (20) of this rule) level results for additional treatment including to an approved lifestyle intervention program, even though the additional treatment is not covered by the WW Program;

(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 OFH;

(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.

(20) The ALERT and abnormal values are as follows:

ALERT:  BMI >= 40

  Systolic blood pressure > 180 mmHg

  Diastolic blood pressure > 110 mmHg

  Fasting or non-fasting total blood cholesterol > 400 mg/dL

  Fasting or non-fasting blood glucose > 375 mg/dL

Abnormal: BMI: Overweight 25-29.9, Obesity (Class 1) 30-34.9, Obesity (Class 2) 35-39.9

  Blood pressure: Prehypertension 120-139 Systolic or 80-90 Diastolic; Stage 1 Hypertension 140-159 Systolic or 90-99 Diastolic; Stage 2 Hypertension > 160 Systolic or > 100 Diastolic

  Total Cholesterol: Borderline-high 200-239, High > 240

  HDL Cholesterol: Low < 40

  LDL (Fasting): 100 or higher

  Triglycerides (Fasting): 150 or higher

  Glucose (Non Fasting): > = 200 plus symptoms

  Glucose (Fasting): FPG 100 to 375

  Glucose (Fasting): OPTT 140 to 375

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0230

Submission of Information by Ancillary Providers

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

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010, 431.150
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0235

Covered Services

(1) The WW Program covers screening and services specific to heart disease, stroke and diabetes. Contracted providers will only be reimbursed for services related to heart disease, stroke and diabetes screening and services.

(2) Covered screening and services include, but are not limited to:

(a) Cholesterol tests;

(b) Glucose or A1C tests;

(c) Triglycerides; and

(d) Consultation related to living a healthy lifestyle.

(3) The WW Program Manual, January 2009, incorporated by reference, includes a complete list of covered services.

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

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0240

Excluded Services

(1) Services and laboratory tests not directly related to heart disease, stroke and diabetes, or not included in the ICD-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 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0245

Claims and Billing

(1) Only an enrolled 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 OFH for providing WW Program covered services.

(2) An enrolled 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 OFH 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 OFH;

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

(3) OFH may not pay a claim older than 12 months, except as provided for in section (4) of this rule. An enrolled 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 OFH makes an error that makes it impossible for an enrolled or ancillary provider to bill within 12 months of the date of service, the enrolled or ancillary provider shall notify OFH of the alleged error and submit the claim to OFH. OFH shall confirm that it made an error prior to payment being made

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

(6) An enrolled 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 enrolled 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 enrolled 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 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0250

Payment

(1) OFH shall only pay claims submitted by an enrolled or ancillary provider for a client.

(2) OFH shall reimburse an enrolled 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) OFH payments for WW Program provider services, unless in error, constitute payment in full.

(5) OFH 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 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0255

Denial or Recovery of Reimbursement Resulting from Review or Audit

(1) OFH’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 409.050
Stats. Implemented: ORS 409.010, 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 OFH determines that an overpayment has been made to an enrolled or ancillary provider, OFH shall seek to recover the amount of overpayment. OFH 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 OFH;

(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) OFH shall provide an enrolled 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 enrolled or ancillary provider shall pay the overpayment amount within 30 calendar days from the date OFH mails the notice of overpayment. A request for a hearing does not change the date the repayment of the overpayment is due.

(5) OFH 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 OFH.

(6) If the provider disagrees with OFH’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 OFH 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 OFH 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 enrolled 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 OFH’s random sample.

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

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

(b) Pursue civil action to recover the overpayment.

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

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

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0265

Client Data Submission

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

(2) An enrolled provider shall submit client data to OFH, in a manner specified by OFH, 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 OFH immediately once it is received by the provider.

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

(4) An enrolled 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 enrolled provider or OFH 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 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0270

Requirements for Financial, Clinical and Other Records

(1) An enrolled 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 OFH, DHS, 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 enrolled or ancillary provider’s participation in the WW Program, including client medical records. An enrolled 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 DHS 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 DHS, or to sanctions.

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0275

Compliance with Federal and State Statutes

(1) Submission of a claim for medical services or supplies provided to a client shall be deemed a representation by the enrolled or ancillary provider to OFH 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) Enrolled 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 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0280

Provider Sanctions

(1) The OFH may sanction an enrolled 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 OFH, 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 OFH 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 OFH;

(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 OFH 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 OFH;

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

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

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

(f) The recovery of investigative and legal costs;

(g) Reduction of any amount otherwise due the enrolled 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 OFH regulations.

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

(4) When an enrolled or ancillary provider fails to meet one or more of the requirements identified in this rule OFH, 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 enrolled 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 OFH’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 OFH decides to sanction an enrolled or ancillary provider, OFH 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 OFH intends to take;

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

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

(6) If OFH makes a final decision to sanction an enrolled or ancillary provider, OFH 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 enrolled or ancillary provider must appeal an immediate or proposed sanction separately from any appeal of audit findings and overpayments.

Stat. Auth.: ORS 409.050
Stats. Implemented: ORS 409.010, 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0285

Provider Appeals (Level 1) -- Claims Reconsideration

An enrolled or ancillary provider disputing a claim or sanction decision by OFH may request reconsideration. The provider must submit the request for reconsideration in writing to OFH. The request must include the reason for the dispute, and any information pertinent to the outcome of the dispute. OFH 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 409.050
Stats. Implemented: ORS 409.010 & 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

333-010-0290

Provider Appeals (Level 2) -- Contested Case Hearing

An enrolled 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 409.050
Stats. Implemented: ORS 409.010 & 431.250
Hist.: PH 1-2009, f. & cert. ef. 2-13-09

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 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 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 Health Divisions Tobacco Prevention and Education Program Request for Proposals.

(11) "Request for Proposals (RFP)" means a written document issued by the Oregon 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 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 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 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 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 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

333-010-0340

School-Based Prevention Programs

The goal of the Oregon 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 tobacco prevention and education programs in school districts throughout Oregon.

(1) Eligibility for Grant Awards:

(a) The Director, in collaboration with the Superintendent, shall accept proposals from school districts to implement tobacco prevention and education programs in compliance with the requirements of this section;

(b) Proposals from consortia of school districts will also be accepted if they comply with the requirements of this section;

(c) Any school-based proposal submitted must include a statement of support from the local tobacco prevention coalition in that county.

(2) Development of the Request for Proposals (RFP) Document. The Director, in collaboration with the Superintendent, shall develop Request for Proposals (RFP) for school districts in consultation with representatives from appropriate groups, which may include but is not limited to, the Governor's Tobacco Reduction Advisory Committee, the Tobacco-Free Coalition of Oregon, 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 time frame prescribed by the Director in collaboration with the Superintendent. School district proposals shall include but not be limited to:

(a) Identified program goals, objectives, activities and evaluation plans in all of the following areas:

(A) Implementation of school policies prohibiting the use of tobacco by youth and adults anywhere on school property;

(B) Tobacco prevention curriculum for grades 6-8;

(C) Teacher training;

(D) Parent and family involvement;

(E) Linkage to community prevention efforts;

(F) Support for smoking cessation efforts for students and school staff;

(G) Participation in program evaluation activities; and

(H) Coordination with other federal and state programs providing tobacco prevention activities.

(b) Statement of support from local coalitions and community-based programs;

(c) Detailed budget for the proposed use of tobacco prevention grant funds.

(4) Review of Proposals:

(a) School district proposals shall be evaluated by a committee appointed by the Director in collaboration with the Superintendent. The Director, in collaboration with the Superintendent, has the authority to include on the review committee persons not employed by the Oregon Health Division or the Oregon Department of Education, including experts in the field of tobacco use reduction;

(b) The Director in collaboration with the Superintendent, may reject any proposal not in compliance with the RFP's instructions;

(c) Review criteria for proposals submitted under this section shall be established by the Director in collaboration with the Superintendent;

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

(5) Awarding of Funds:

(a) Funding under this section shall be awarded to school districts on the basis of availability of funding and merit of proposal;

(b) The Director, in collaboration with the Superintendent, may negotiate modifications of an applicant's proposal, and award funds only after such modifications have been agreed upon by both the Director and the school district.

(c) The Director, in collaboration with the Superintendent, shall determine the 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

333-010-0350

Statewide Public Awareness and Education Programs

The goal of the Oregon 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 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 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 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 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

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 Department of Human Services, 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 Department of Human Services, 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

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