641—37.2 (135) Components of the IA BCCEDP. The IA BCCEDP shall include the following key components:
	 37.2(1) Program and fiscal management shall be conducted by ensuring strategic planning, implementation, coordination, integration, and evaluation of all programmatic activities and administrative systems, as well as the development of key communication channels and oversight mechanisms to aid in these processes. Program management shall ensure that infrastructure adequately supports service delivery.
	 37.2(2) Service delivery of specific and appropriate clinical procedures to detect breast and cervical abnormalities for women enrolled in the IA BCCEDP shall be directly provided or provided through contractual arrangements.
	  a.   	 IA BCCEDP shall cover services including, but not limited to, the following when those services are provided by a participating health care provider who has a signed cooperative agreement with IA BCCEDP. Payment shall be based on Medicare Part B rates (Title XIX).
	 (1) 	 Physical examinations, which must include one or more of the following screening services: CBE, pelvic exam, or Pap test;
	 (2) 	 Mammography (screening and diagnostic);
	 (3) 	 Breast ultrasound, when used as an adjunct to mammography;
	 (4) 	 Fine-needle aspiration of breast cysts;
	 (5) 	 Breast biopsies, excisional and nonexcisional (physician charges only; hospital charges are not covered);
	 (6) 	 Colposcopy of the cervix, with or without biopsy;
	 (7) 	 Surgical consultations for diagnosis of breast and cervical cancer;
	 (8) 	 Pathology charges for breast and cervical biopsies;
	 (9) 	 Anesthesia for breast biopsies (health care provider charges only; hospital charges and supplies are not covered).
	  b.   	 Services not covered by IA BCCEDP include, but are not limited to, the following:
	 (1) 	 Services not related to breast or cervical cancer screening or diagnosis;
	 (2) 	 Treatment procedures and services;
	 (3) 	 Services provided by nonparticipating providers;
	 (4) 	 Hospital charges for breast biopsies and anesthesia;
	 (5) 	 Inpatient services.
	  c.   	 A health care provider who has a signed cooperative agreement with the IA BCCEDP shall be subject to the following:
	 (1) 	 The health care provider agrees that reimbursement of procedures and services provided shall not exceed the amount that would be paid under Medicare Part B rates of Title XVIII of the Social Security Act;
	 (2) 	 A mammography health care provider shall ensure that the provider's facility has current FDA certification and ACR or state of Iowa accreditation and is a Medicare and Medicaid-approved facility utilizing BI-RADS and following ACR guidelines for mammography report content;
	 (3) 	 A board-certified radiologist must be immediately available to determine selection of views and readings when a diagnostic mammogram is performed;
	 (4) 	 The health care provider shall submit cytology and pathology specimens obtained to a CLIA-certified laboratory for processing. The laboratory shall provide cytological reading and analysis of cervical and vaginal Pap tests by certified/registered cytotechnologists. Cytology (Pap) tests shall be reported using current TBS. The laboratory shall provide board-certified pathologists or experienced certified cytotechnologists to rescreen all analyses and readings of cervical and breast biopsies;
	 (5) 	 The health care provider shall practice according to the current standards of medical care for breast and cervical cancer early detection, diagnosis, and treatment;
	 (6) 	 Service delivery may be provided in a variety of settings. Service delivery must, however, include:
	  1. 	 Providing screening services for specific geographic areas;
	  2. 	 Providing a point of contact for scheduling appointments;
	  3. 	 Providing age and income eligibility screening;
	  4. 	 Providing comprehensive breast and cervical cancer screening to eligible women;
	  5. 	 Providing referral and follow-up for women with abnormal screening results;
	  6. 	 Providing the required reporting system for screening and follow-up activities;
	  7. 	 Providing population-based education, outreach, and recruitment activities;
	 (7) 	 The health care provider shall ensure compliance with this chapter and other terms and conditions included in the signed cooperative agreement.
	 37.2(3) Referral, tracking, and follow-up utilizing a data system to monitor each enrolled woman’s receipt of screening/rescreening, diagnostic, and treatment procedures shall be conducted by IA BCCEDP and contracted county board of health designated agency staff.
	  a.   	 The enrolled woman shall be notified by contracted county board of health designated agency staff of the results of the service, whether the results are normal, benign, or abnormal.
	  b.   	 The data system shall provide tracking of appropriate and timely clinical services following an abnormal test result or diagnosis of cancer.
	  c.   	 If the enrolled woman has an abnormal Pap test or breast screening, the health care provider shall provide to the woman a comprehensive referral directing her to appropriate additional diagnostic or treatment services.
	  d.   	 The comprehensive referral shall be written. Follow-up shall be conducted to determine whether services were timely, completed, or met.
	 37.2(4) IA BCCEDP and contracted county board of health designated agency staff shall provide case management and assist clients diagnosed with cancer through the program to obtain needed treatment services.
	 37.2(5) IA BCCEDP staff shall use quality assurance and improvement techniques including use of established standards, systems, policies and procedures to monitor, assess and identify practical methods for improvement of the program and its components.
	  a.   	 Quality assurance tools shall include utilizing FDA and ACR minimum standards for mammography facilities and CLIA minimum standards for cytopathology and pathology laboratories.
	  b.   	 Quality assurance measures shall contribute to the identification of corrective actions to be taken to remedy problems found as a result of investigating quality of care.
	 37.2(6) Professional development shall be provided by IA BCCEDP and contracted county board of health designated agency staff through a variety of channels and activities that enable professionals to perform their jobs competently, identify needs and resources, and contribute to ensuring that health care delivery systems provide positive clinical outcomes.
	 37.2(7) IA BCCEDP and contracted county board of health designated agency staff shall provide population-based education and recruitment that involve the systematic design and delivery of clear and consistent messages about breast and cervical cancer and the benefits of early detection, using a variety of methods and strategies to reach priority populations. Outreach activities should focus on women who have never or rarely been screened and should work toward the removal of barriers to care (i.e., the need for child care, respite care, interpreter services and transportation) through collaborative activities with other community organizations.
	 37.2(8) IA BCCEDP may develop coalitions and partnerships to bring together groups and individuals that establish a reciprocal agreement for sharing resources and responsibilities to achieve the common goal of reducing breast and cervical cancer mortality.
	 37.2(9) IA BCCEDP shall conduct surveillance utilizing continuous, proactive, timely and systematic collection, analysis, interpretation and dissemination of breast and cervical cancer screening behaviors and incidence, prevalence, survival, and mortality rates. Epidemiological studies shall be conducted utilizing minimum data elements and other data sources to establish trends of disease, diagnosis, treatment, and research needs. Program planning, implementation, and evaluation shall be based on the epidemiological evidence.
	 37.2(10) Evaluation of the program shall be conducted through systematic documentation of the operations and outcomes of the program, compared to a set of explicit or implicit standards or objectives.
	  a.   	 MATF shall review the service delivery contractual agreements as to their outcomes.
	  b.   	 MATF shall make recommendations based on the evaluation in its annual report.
[ARC 7670B, IAB 4/8/09, effective 5/13/09]