641—37.1 (135) Definitions. For purposes of this chapter, the following definitions apply:
“Abnormal screen” means a suspicion of breast or cervical cancer.
	  1. 	 A suspicion of breast cancer includes clinical breast exam findings of: palpable breast mass, breast dimpling, nipple retraction, bloody nipple discharge, palpable lymph nodes around clavicle or axilla, nipple erythema and scaliness, a mammography result of breast imaging reporting and data systems (BI-RADS) category 4 (suspicious abnormality suggesting need for biopsy) or category 5 (highly suggestive of malignancy) (ICD-9 793.8), breast biopsy result of ductal cancer in situ, lobular cancer in situ (ICD-9 233.0), or breast or lymph node (or other) biopsy result of breast cancer.
	  2. 	 Suspicion of cervical cancer is a Pap test result of atypical squamous cells cannot exclude high-grade squamous intraepithelial lesions (ASC-H) (ICD-9 795.02), atypical glandular cells (AGC) (ICD-9 795.00), low-grade squamous intraepithelial lesions (LSIL) (ICD-9 622.11 or 795.03), or high-grade squamous intraepithelial lesions (HSIL) (ICD-9 622.12 or 795.04), leukoplakia of the cervix (ICD-9 622.2), or cervical biopsy result of cervical intraepithelial neoplasia II or III (ICD-9 622.10, 622.11, 622.12, 795.03, or 795.04), or cancer in situ (ICD-9 233.1).
“Advanced registered nurse practitioner” means an individual licensed to practice under 655 Iowa Administrative Code Chapter 7.
“American College of Radiology”  or “ACR”  means one of the Food and Drug Administration-recognized accreditation bodies for minimum quality standards for personnel, equipment, and record keeping in facilities that provide mammography.
“Benign” means a noncancerous condition that does not spread to other parts of the body.
“Bethesda system”  or “TBS”  means a system that was developed to provide uniform diagnostic terminology for reporting cervical or vaginal cytologic findings to facilitate communication between the laboratory and the clinician.
“Biopsy” means the removal of a sample or an entire abnormality for microscopic examination to diagnose a problem. Examples of a sampling would be a core biopsy or incisional biopsy; an example of entire removal would be an excisional biopsy.
“Breast image reporting and data systems”  or “BI-RADS”  means a standardized reporting system for mammography reports.
“Breast ultrasound” means the use of high-energy sound waves that are bounced off internal tissues and make echoes to produce a pictorial representation of the internal structure of the breast.
“Cancer” means a malignant tumor of potentially unlimited growth of new cells that expand locally by invasion and systemically by metastasis.
“Carcinoma in situ” means cell changes in which malignant cells are localized and may press against adjoining tissue but have not penetrated or spread beyond their site of origin.
“Case management” means the IA BCCEDP component that involves establishing, brokering, and sustaining a system of available clinical and essential support services for all women enrolled in the program.
“Clinical breast examination”  or “CBE”  means complete examination of a woman’s breast and axilla with palpation, including examination of the breast in both the upright and supine positions by a health care provider.
“Clinical Laboratory Improvement Act of 1988”  or “CLIA”  means the law which established minimum quality standards for personnel and quality assurance methods that monitor patient test management and assess quality control, proficiency testing, and personnel handling of laboratory and pathology specimens.
“Colposcopy” means a procedure that allows close examination of the surface of the cervix with a high-powered microscope.
“Cooperative agreement” means a signed contract between the department and another party, for example, a health care provider. This contract allows the department to pay the health care provider for providing services to IA BCCEDP participants.
“Creditable coverage” means any insurance that pays for medical bills incurred for the screening, diagnosis, or treatment of breast and cervical cancer. Creditable coverage as described by the Health Insurance Portability and Accountability Act of 1996 includes, but is not limited to, group health plans or health insurance coverage consisting of medical care under any hospital or medical service policy, health maintenance organization, Medicare Part A or B, Medicaid, armed forces insurance, or state health risk pool. A woman who has creditable coverage shall not be eligible for the Medicaid coverage option of breast and cervical cancer treatment.
“Creditable coverage circumstances” means those instances in which a woman has creditable coverage but is not actually covered for treatment of breast or cervical cancer.
	  1. 	 When there is a preexisting-condition exclusion or when the annual or lifetime limit on benefits has been exhausted, a woman is not considered to have creditable coverage for this treatment.
	  2. 	 If the woman has limited coverage, such as a high deductible, limited drug coverage, or limits on the number of outpatient visits, the woman is still considered to have creditable coverage and is not eligible for coverage under the breast and cervical cancer treatment (BCCT) option of Medicaid.
	  3. 	 If the woman has a policy with a limited scope of coverage, such as only dental, vision, or long-term care, or has a policy that covers only a specific disease or illness, she is not considered to have creditable coverage, unless the policy provides coverage for breast and cervical cancer treatment.
	  4. 	 For the purposes of this program, eligibility for Indian Health Services or tribal health care is not considered creditable coverage (according to United States Senate File 1741 – Native American Breast and Cervical Cancer Treatment Technical Amendment Act of 2001).
“Cytology” means the scientific study of cells.
“Cytopathology” means the scientific study of cells in disease.
“Cytotechnologist” means a medical technician trained in the identification of cells and cellular abnormalities.
“Department” means the Iowa department of public health.
“Diagnostic mammography” means a radiological examination performed for appropriate clinical indications such as breast mass(es), other breast signs or symptoms (spontaneous nipple discharge, skin changes), or special cases, such as a history of breast cancer with breast conservation or augmented breasts.
“Follow-up” means the IA BCCEDP component that involves a system for seeking information about or reviewing an abnormal condition, rescreening, or recall for annual visits.
“Food and Drug Administration”  or “FDA”  means the federal governmental body which certifies that a mammography facility meets minimum quality standards for personnel, equipment, and record keeping.
“Gynecologist” means a physician who specializes in diseases of the reproductive organs in women.
“Health care provider” means any physician, advanced registered nurse practitioner, or physician assistant who is licensed by the state of Iowa and provides care to IA BCCEDP-enrolled women.
“Infrastructure” means the basic framework of sufficient staff and adequate support systems to plan, implement, and evaluate the components of the IA BCCEDP.
“In need of treatment” means that a medical or surgical intervention is required because of an abnormal finding of breast or cervical cancer or precancer that was determined as a result of a screening or diagnostic procedure for breast or cervical cancer/precancer under the NBCCEDP.
“International Classification of Disease, 9th edition”  or “ICD-9”  means a standardized classification of diseases, injuries, and reasons of death, by cause and anatomic localization and systematically put into a number of up to six digits, which allows clinicians, statisticians, politicians, health planners and others to speak a common language, both in the United States and internationally.
“Iowa breast and cervical cancer early detection program”  or “IA BCCEDP”  means a comprehensive breast and cervical cancer screening program established and funded under Title XV of the federal Public Health Service Act and administered by the Iowa department of public health, with the delegated responsibility of implementation and evaluation from the Centers for Disease Control and Prevention, Division of Cancer Prevention and Control.
“Medicaid” means the program of medical aid designed for those unable to afford regular medical service, financed by federal and state payment sources, and authorized by Title XIX of the Social Security Act.
“Medical advisory task force”  or “MATF”  means an advisory board utilized by the IA BCCEDP to offer knowledge and experience as related to the fields of expertise of the members of the task force. Duties of the MATF may include, but are not limited to, the following:
	  1. 	 Review and make recommendations for clinical service expansion.
	  2. 	 Review of program-developed clinical protocols.
	  3. 	 Provision of recommendations related to other clinical and client-related issues.
	  4. 	 Input related to quality assurance issues.
	  5. 	 Review of program screening and diagnostic data.
“Medicare” means the program of federal payment source for health benefits, especially for the aged, that is authorized by Title XVIII of the Social Security Act.
“Minimum data elements”  or “MDEs”  means a set of standardized data elements used to collect demographic and clinical information on women whose screening or diagnosis was paid for with NBCCEDP funds. MDEs were developed by the Centers for Disease Control and Prevention, Division of Cancer Prevention and Control, to ensure that consistent and complete information is collected on women whose screening or diagnosis was paid for with NBCCEDP funding.
“National breast and cervical cancer early detection program”  or “NBCCEDP”  means a program established with the passage of the Breast and Cervical Cancer Mortality Prevention Act of 1990 (Public Law 101-354). The law authorizes the Centers for Disease Control and Prevention to establish a program of grants to states, tribes, and territories for the purpose of increasing the early detection of breast and cervical cancer, particularly among low-income, uninsured, and underserved women.
“Oncologist” means a physician who is a specialist who treats or studies the physical, chemical, and biologic properties and features of neoplasms, including causation, pathogenesis, and treatment.
“Outreach” means the IA BCCEDP component that involves recruiting targeted populations or persons who never or rarely utilize preventive health services.
“Pap test” means a screening test that collects cells from the cervix for examination under a microscope. The Pap test can detect abnormal cells or precancerous cells before cancer develops.
“Pathologist” means a physician who is a specialist in identifying diseases by studying cells and tissues under a microscope.
“Physician” means an individual licensed to practice under Iowa Code chapter 148.
“Physician assistant” means an individual licensed to practice under Iowa Code chapter 148C.
“Precancerous” means a condition that may become or is likely to become cancer.
“Program and fiscal management” means the IA BCCEDP component that conducts planning, organizing, directing, coordinating, managing, budgeting, and evaluating program activities.
“Radiologist” means a physician who specializes in creating and interpreting pictures of areas inside the body. The pictures are produced with X-rays, sound waves, or other types of energy.
“Rarely been screened” means, as defined for the NBCCEDP, that a woman has not had cervical cancer screening within the last five years.
“Recruitment” means the IA BCCEDP component that involves enrolling targeted populations or persons who never or rarely utilize preventive health services.
“Referral” means the IA BCCEDP component that involves directing women with abnormal screening results to appropriate resources for follow-up action.
“Screening mammography” means the use of X-ray of the breasts of asymptomatic women in an attempt to detect abnormal lesions of the breast when they are small, nonpalpable, and confined to the breast.
“Service delivery” means providing, either directly or through contractual arrangements, comprehensive breast and cervical cancer screening, diagnosis, and treatment services through tracking of screening intervals, timeliness of diagnosis, and timeliness of treatment of clients.
“Surgeon” means a physician who treats disease, injury, or deformity by physical operation or manipulation.
“Surveillance” means the IA BCCEDP component that involves the systematic collection, analysis, and interpretation of health data.
“Susan G. Komen for the Cure” means an international organization with a network of volunteers working through local affiliates and Komen Race for the Cure® events to eradicate breast cancer as a life-threatening disease by advancing research, education, screening, and treatment.
[ARC 7670B, IAB 4/8/09, effective 5/13/09]