CTR070071_Contract_Documents.pdf

CTR070071

UPON SIGNATURE

26th February 24

PART ONE (1) - Table of Contents

ARIZONA DEPARTMENT

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

REQUEST FOR PROPOSAL No.: BPM005681 Well Woman Health Check Program

*The following table of contents applies to all attachment documents in APP for this Solicitation*

SECTION CONTENT

REQUIREMENTS - Part One (1) Notice Page

Table of Contents

Scope of Services

Special Terms and Conditions

Uniform Terms and Conditions

Exhibit A: Contractor’s Expenditure Report (CER)

Exhibit B: B & C Bars Template

Exhibit C: Quarterly Report Template

INSTRUCTIONS - Part Two (2) Special Instructions to Offerors

Uniform Instructions to Offerors

ATTACHMENTS - Located in APP

• Attachment A: Offer and Acceptance

• Attachment B: Notices, Correspondence, Reports, and Payments

• Attachment C: Designation of Confidential, Trade Secret and Proprietary

• Attachment D: Participation if Boycott of Israel

• Attachment E: Forced Labor of Ethnic Uyghurs Ban

• Attachment F: Budget Worksheet javascript:window.parent.navigate(%22/media_461531632/Arizona_State_Seal.html%22);

PART ONE (1) - Scope of Services

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

SCOPE OF SERVICES

1. DEFINITIONS

1.1. ADHS WWHP – Arizona Department of Health Services Well Woman Health Check Program in Arizona, an entity of the Division of Prevention and the Bureau of Chronic Disease and Health Promotions and managed by the Office of Chronic Disease and Population Health.

1.2. AHCCCS – Arizona Health Care Cost Containment System, Arizona’s Medicaid Program.

1.3. BCCTP – Breast and Cervical Cancer Treatment Program.

1.4. CDC – Centers for Disease Control and Prevention. CDC is the federal funding source for WWHP.

1.5. Client – A woman who is eligible to receive WWHP services and who has been enrolled in the Program.

1.6. Community Referral – A community Referral is a woman referred to the Breast and Cervical Cancer Treatment Program who has been diagnosed with breast cancer, pre-cancerous cervical lesions or cervical cancer outside of the Well Woman Health Check Program (WWHP).

1.7. Contractor – A service provider under a Contract to provide WWHP services for ADHS. Also referred to in this Scope of Work as the Contractor.

1.8. Contractor’s Expenditure Report (CER) – A monthly report in which claims for reimbursement of allowable costs are submitted to the Program Director for review and approval, and then forwarded to ADHS WWHP financial staff for processing and payment. (Form to be provided by WWHP financial staff)

1.9. Department – Arizona Department of Health Services (ADHS).

1.10. Evidence Based Initiatives – Activities or strategies that are derived from or informed by objective evidence. For this program the Evidence Based Initiatives (EBIs) can be found in The Guide to Community Preventive Services.

1.11. HIPAA – Health Insurance Portability Accountability and Affordability Act. All WWHP information and data shall be managed within HIPAA guidelines.

1.12. MDEs – Minimum Data Elements are clinical information forms containing data required by the CDC.

The data is entered into CaST and then submitted in de-identified format to CDC.

1.13. Navigation Only – The WWHP pays to screen and navigate uninsured or under-insured clients. The program also pays to navigate insured clients through breast and cervical cancer screening and diagnostics and into treatment if necessary.

1.14. Population Health – A population health perspective encompasses the ability to assess the health needs of a specific population; implement and evaluate interventions to improve the health of that population;

and provide care for individual patients in the context of the culture, health status, and health needs of the populations of which that patient is a member.

1.15. Program – The system of services for breast and cervical cancer screening and diagnostics that serves selected communities and functions under the auspices of the WWHP, ADHS. In addition to screening and diagnostics, the program also requires quality improvement initiatives regarding breast and cervical cancer screening and diagnostics.

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https://www.thecommunityguide.org/ https://www.thecommunityguide.org/

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

1.16. Program Coordinator – Personnel hired by the Contractor to administer the Contract with ADHS WWHP.

1.17. Program Director – Personnel hired by ADHS to implement and monitor the WWHP.

1.18. Program Manual – The CDC Manual shall be distributed to the Contractor via email upon Contract. Forms and clinical algorithms shall also be made available upon Contract.

1.19. Reimbursement – Payments made on the basis of claims itemized and properly justified in the CER.

Clinical services reimbursed at Medicare reimbursement rates. Documentation shall be provided to support all expenses listed on CER.

1.20. Reports – All required reports and reporting information, including but not limited to, the Labor Activity Report, Quarterly Report, monthly CER, Baseline Screening Report and the Annual Work Plan. Reports are explained during quarterly Contractor meetings. The ADHS WWHP may require additional reports not defined in this Contract.

1.21. Medical Service Provider – All Medical Doctors (M.D.s) or Doctors of Osteopathy (D.O.s) referring patients to the BCCTP shall be currently licensed under the provisions of the Arizona Revised Statutes, Title 32, Chapter 13 or 17 or Contracted with an AHCCCS Health Plan. All other personnel providing services shall be registered, licensed, or board certified in Arizona in their respective fields, as applicable and/or AHCCCS providers. Indian Health Service providers shall be licensed in Arizona or per The Federal Tort Claims Act (FTCA), 28 U.S.C. §§ 1346(b), 2671-2680. If the referring physician is to be the treating physician, they need to be Contracted with an AHCCCS Health Plan. Indian Health Service providers shall be licensed in Arizona or per The Federal Tort Claims Act (FTCA), 28 U.S.C. §§ 1346(b), 2671-2680.

1.22. Quality Improvement – Systematic and continuous actions leading to measurable improvement in health care services and the health status of targeted patient groups.

1.23. Systems Change – The process of improving the capacity of the public health system to work with many sectors to improve the health status of all people in a community. Community is defined as the geographic area with a strong focus on those using services from those providers.

1.24. Priority Funded Population – The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) eligible population includes those who are uninsured or underinsured, at or below 250% of the federal poverty level, aged forty to sixty-four (40 to 64) years for breast cancer services, and aged twenty-one to sixty-four (21 to 64) years for cervical cancer services. Those who are symptomatic or high-risk under the age of forty (40) years and those over the age of sixty-four (64) who do not have Medicare Part B may also receive services through the program. Those living in rural and frontier geographic areas; culturally isolated persons; incarcerated or institutionalized clients; medically underserved persons; person from minorities defined by race, religion, ethnicity, or culture, including African American, Alaska Native, American Indian, Asian American, Pacific Islander and Hispanic person:

lesbian, gay, bisexual, or transgender (LGBT) persons, and persons who have low literacy, non-English speaking language barriers, and disabilities.

1.25. WISEWOMAN – The purpose of the WISEWOMAN program is to extend preventive health services to achieve optimal cardiovascular health for participants ages thirty-five to sixty-four (35 to 64) who are participants of the CDC’s funded NBCCEDP. The program helps participants understand and reduce their risk of cardiovascular disease and benefit from early detection and treatment. With health equity as

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007 a guiding principle, WISEWOMAN provides culturally-informed risk factor screenings and program services that are mindful of the social determinants of health.

Priority Population:

1.25.1. Low-income persons (Clients),

1.25.2. Ages thirty-five to sixty-four (35 to 64) years who are uninsured or under-insured, and

1.25.3. Eligible to participate in NBCCEDP.

WISEWOMAN is a direct services program, which requires providers to follow a specific program flow in order to ensure appropriate identification, assessment, and referral of participants. The ADHS WWHP applied for the WISEWOMAN grant and upon award of the grant, all Contractor shall be assessed and evaluated to determine their ability to implement the WISEWOMAN program within their prospective clinics. Additional funding shall be provided to Contractor who participate in WISEWOMAN to support implementation of the program.

2. BACKGROUND

ADHS, Division of Public Health Services (PHS), Bureau of Chronic Disease and Health Promotions (BCDHP) receives funding through a cooperative agreement with the CDC and from the State of Arizona to provide a statewide breast and cervical cancer screening and quality improvement program, known locally as the Well Woman Health Check Program (WWHP). The WWHP is part of the NBCCEDP, which was authorized when the U.S. Congress passed the Breast and Cervical Cancer Mortality Prevention Act of 1990, Public Law 101-354 and reauthorized April 20, 2007. The Act placed the responsibility for NBCCEDP with the United States Government’s CDC. It also provided the foundation of NBCCEDP policies and requirements with regard to program eligibility and operations in each state.

The Breast and Cervical Cancer Mortality and Prevention Act of 1990 strictly prohibits use of NBCCEDP funds for cancer treatment. In October 2000, the U.S. Congress passed the Breast and Cervical Cancer Prevention and Treatment Act of 2000, Public Law 106-354. This law gives states the authority to provide optional Medicaid coverage to certain breast or cervical cancer patients. In the spring of 2001, the Arizona Legislature passed H.B.

2194 that authorizes AHCCCS, effective January 1, 2002, to provide cancer treatment for certain client diagnosed through the WWHP with breast cancer, pre-cancerous cervical lesions and cervical cancer. This was called the BCCTP. This law was changed in 2012; beginning on August 2, 2012, uninsured Arizona client, diagnosed with breast or cervical cancer, with an income at or below 250% of the Federal Poverty Level are eligible for treatment through the BCCTP provided by AHCCCS. To be eligible for treatment, clients shall be under the age of sixty-five (65) (aged forty to sixty-four (40 to 64) years for breast cancer, and aged twenty-one to sixty-four (21 to 64) years for cervical cancer), a resident of Arizona, have no credible health insurance coverage, be diagnosed with a breast cancer, cervical cancer or precancerous cervical lesion and be a U.S. citizen or legal permanent resident of at least five (5) years.

2.1 Eligibility for Enrollment in the WWHP Program:

To qualify as a client for breast and cervical cancer screening and diagnostic services under WWHP:

2.1.1 The client’s income shall not exceed 250% of the Federal Poverty Level established annually by the Federal Register. A clear and usable format can be found at the following site, wellwomanhealthcheck.org ,

2.1.2 The client shall be a permanent resident of Arizona, or have been in the State for at least one

(1) day with the intention of establishing permanent residence in Arizona, http://www.wellwomanhealthcheck.org/

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

2.1.3 The client shall be uninsured or under-insured. Under-insured is defined as health insurance that does not cover preventative health care, or where the unmet deductible or co-pay exceeds one hundred dollars ($100.00),

2.1.4 Priority shall be given to enrollment of traditionally underserved populations outside the mainstream of patient care including those:

2.1.4.1 Living in rural and frontier geographic areas;

2.1.4.2 Culturally isolated; incarcerated or institutionalized;

2.1.4.3 Medically underserved; racial and ethnic minorities, clients with disabilities, lesbians, gay, bisexual, transgender, or queer; and

2.1.4.4 With low literacy or non-English speaking language barriers.

2.1.5 Insured clients meeting the program income guidelines qualify for Navigation Only services through the WWHP,

2.1.6 The WWHP Contractor shall be responsible for directing clients requesting WWHP services to Medicaid (AHCCCS) and other insurance options. If clients are not able to afford the coverage provided via other insurance options and not eligible for AHCCCS they can then be enrolled in the WWHP. More information will be provided regarding this requirement as other insurance options become available,

2.1.6.1 The Contractor are responsible for using the flowsheets and attestations provided during open enrollment for the Affordable Care Act; and

2.1.6.2 The Contractor shall have certified enrollment specialists on site or have established working relationships with local certified enrollment specialists;

2.1.7 Clients sixty-five (65) years of age or older who also meet the above requirements:

2.1.7.1 Who do not have Medicare Part B may be enrolled in the WWHP;

2.1.7.2 These clients shall receive screening and diagnostic services following the same protocols used for other clients in the program;

2.1.7.3 If diagnosed with cancer, this population of client’s is not eligible to receive treatment services under the Breast and Cervical Cancer Prevention and Treatment Act of 2000;

2.1.7.4 These clients, though they do not have Part B, Medicare, are eligible for other benefits through Medicare. These clients, when possible, shall be referred to healthcare organizations or agencies providing benefits provided under Medicare Parts A and B. If a client is unable to pay Medicare premiums, The client may be eligible for assistance under AHCCCS; and

2.1.7.5 NBCCEDP funds can be used to evaluate clients under the age of forty (40) who are asymptomatic and has been determined to be at high risk for breast cancer.

2.1.8 Clients forty to sixty-four (40 to 64) years of age:

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

2.1.8.1 Clients fifty to sixty-four (50 to 64) years of age are CDC’s priority population for mammography screening services and reimbursed with federal funds;

2.1.8.2 Clients fifty (50) years of age and older shall account for a majority of the mammography services, utilizing federal funding provided to WWHP Contractor;

2.1.8.3 Mammography services, utilizing state funding, shall be provided to clients forty to forty-nine (40 to 49) years of age;

2.1.8.4 Clients with an intact cervix or history of cervical neoplasia are eligible to receive Pap test screening in accordance with the WWHP cervical screening policy;

2.1.8.5 The clinical breast examination, pelvic examination and Pap test (if necessary) are included in the office visit reimbursement. Office visits solely for the purpose of giving the patient the referral for a mammogram is not reimbursed. Providing the referral for the mammogram shall occur at the initial visit; and

2.1.8.6 Clients from populations with high rates of late-stage disease and high mortality shall be the focus of the program.

2.1.9 Clients under forty (40) years of age:

2.1.9.1 Clients less than forty (40) years of age may be enrolled for breast cancer screening and diagnostic services if they exhibit clinically confirmed symptoms of breast cancer. Clients are eligible for cervical cancer screening at the age of twenty-one (21);

2.1.9.2 Once the client’s abnormality has been resolved and the recommendation is to return to routine screening intervals, the client shall be removed from WWHP rolls and referred to the local Title V (Maternal and Child Health Service Block Grant) or Title X (Arizona Family Planning) program. Clients under age twenty-one (21) are not typically eligible for the program. Clients under age twenty-one (21) with symptoms shall be addressed on a case-by-case basis and in consideration of CDC guidelines; and

2.1.9.3 Clients not eligible to receive Medicare Part B and those who are Medicare-eligible but cannot pay the premium to enroll in Medicare Part B may receive mammograms through the NBCCEDP.

2.2 Eligibility for Treatment:

2.2.1 Certain clients screened through the WWHP are eligible for treatment provided through

AHCCCS. Each WWHP eligible client who has been clinically diagnosed with breast cancer, cervical cancer, or pre-cancerous cervical lesions (CIN II or CIN III) shall be screened for eligibility for the Breast and Cervical Cancer Treatment Program (BCCTP), facilitated by AHCCCS. Those documents include: pathology report showing a diagnosis of breast cancer, cervical cancer, or pre-cancerous cervical lesions; BC-100 Referral Form; WWHP Demographic and Eligibility Form; AHCCCS Application; copies of Arizona driver’s license, social security card, U.S. Birth Certificate or Legal Permanent Resident card with at least five

(5) years of legal residency; and documents demonstrating proof of current gross household income. If the woman has legal permanent residency status, and has been in the US less than five (5) years the Sponsor Deeming Form AH-611 shall also be completed. All application

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007 documents for the BCCTP are found online at www.wellwomanhealthcheck.org/bcctp . When a packet is complete, the Contractor is responsible for forwarding it to the ADHS WWHP for review. ADHS shall submit the approved documents to the AHCCCS BCCTP.

2.2.2 Clients not eligible for treatment services under the Breast and Cervical Cancer Prevention and

Treatment Act shall be referred to clinicians willing to donate and/or provide services on a low cost/no cost basis. Available donated funds from foundations and/or organizations may be used to offset the treatment costs for these clients. If Contractor’s chooses to serve clients not eligible for treatment under the Breast and Cervical Cancer Prevention and Treatment Act, shall guarantee treatment within sixty (60) days from the date of diagnosis per CDC program guidelines. If Contractor is unable to access these treatment services in a timely fashion, future screening efforts shall be limited to only those clients eligible under the Breast and Cervical Cancer Prevention and Treatment Act.

2.2.3 Regardless of the source of treatment funds, the Contractor is responsible for ensuring treatment is initiated within program timeframes and reporting the treatment start date to ADHS, in writing, via email, when the treatment is initiated. The time from diagnosis to treatment shall be less than sixty (60) days. These clients shall be tracked up to and including treatment initiation. Any tracking forms provided by ADHS shall be used by the Contractor. This requirement also applies to Navigation Only patients.

3. SERVICE AREA

Contractor are currently needed to service all areas in the State of Arizona.

4. OBJECTIVES

Provide comprehensive breast and cervical cancer screening and diagnostic services, known locally as the WWHP. The WWHP provides services in accordance with Public Law 101-354, the Breast and Cervical Cancer Mortality Prevention Act of 1990. The ADHS, WWHP Contractor, WWHP service providers, and other partners work together to accomplish this mandate through the program components:

4.1 Program management and collaboration;

4.2 Partnerships and coalition participation for cancer control and prevention;

4.3 Public education and recruitment;

4.4 Professional development;

4.5 Quality assurance and improvement;

4.6 Breast and cervical cancer screening, referral, tracking, follow-up case management, and re-screening;

4.7 Navigation Only;

4.8 Systems change;

4.9 Data management and surveillance; and

4.10 Program assessment and evaluation.

http://www.wellwomanhealthcheck.org/bcctp https://ftp.cdc.gov/pub/publications/cancer/nbccedp/legislation/law.htm

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

5. SCOPE OF SERVICE

The Contractor shall develop, implement and evaluate a WWHP that includes:

5.1 Ongoing in-reach, outreach and the recruitment of eligible clients prioritizing the CDC priority funded populations;

5.2 Providing accessible, timely, and quality breast and cervical cancer screening services for uninsured and under-insured patients among other eligibility criteria;

5.3 Implementation of EBIs within the participating clinics;

5.4 Providing accessible, timely and quality case management and navigation to insured patients;

5.5 Active participation in cancer coalitions and early detection and prevention workgroups that shall assist the WWHP including but not limited to:

5.5.1 Improving and expanding WWHP services;

5.5.2 Identifying and partnering with referral resources within local communities;

5.5.3 Coordinating community services to reduce duplicative efforts;

5.5.4 Securing accessible treatment and follow-up services for WWHP clients diagnosed with cancer who are ineligible for treatment services under the Breast and Cervical Cancer Prevention and Treatment Act of 2000. (Breast and Cervical Cancer Treatment Program);

5.5.5 Supporting enrollment in the Breast and Cervical Cancer Treatment Program for community members diagnosed with breast and/or cervical cancer outside of the WWHP.

5.5.6 Working with community partners to increase breast and cervical cancer screening rates in their geographic area and referrals to the BCCTP;

5.5.7 Ongoing provider education in the Contractor’s area of responsibility. Education shall include

WWHP purpose, eligibility for the WWHP and the BCCTP, program guidelines, and survivorship resources;

5.5.8 Navigation of clients diagnosed with breast and/or cervical cancer to survivorship support. This can be accomplished by linking these clients with resources on WWHP Survivorship website, wellwomanhealthcheck;

5.5.9 Systems Change and Quality Improvement activities that increase the breast and cervical cancer screening rates for all clients in the Contractor’s area of responsibility;

5.6 Provide tobacco use assessment and Referral to all clients participating in the program including referral to smoking cessation support such as ASHLine and document;

5.7 Ongoing community and provider education regarding the expanded BCCTP availability, process, and guidelines;

5.8 Ongoing provider education regarding the need to report cancer cases to the Arizona Cancer Registry;

5.9 Ongoing provider education regarding clinical algorithms; and https://www.azdhs.gov/prevention/tobacco-chronic-disease/cancer-prevention-control/index.php#healthcheck-home

OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

5.10 Utilization of mobile mammography units or establish partnerships with mobile mammography units to reach isolated or medically underserved populations.

6. TASKS/METHODS OF ACCOUNTABILITY

6.1 Staffing and Reporting: The Contractor shall hire and retain a Program Coordinator, funded by WWHP, to perform functions necessary for compliance with the following program components:

6.1.1 Labor Activity Reports shall reflect actual WWHP hours of staff time for reimbursement and are to be maintained in Contractor files for audit purposes. When staff changes occur, the Program Director shall be notified in writing within fifteen (15) days,

6.1.2 If key personnel are not available for work under this Contract for a continuous period exceeding thirty (30) calendar days, or are expected to devote substantially less effort to the work than initially anticipated, the Contractor shall immediately notify the Program Director, and shall replace such personnel with personnel substantially equal in ability and qualifications within thirty (30) days,

6.1.3 The Contractor shall submit monthly CERs to the Program Director and Program Manager for reimbursement with accurate and complete forms. Services shall be billed within forty (40) days of the date of service. Reimbursement may be denied for services billed after forty (40) days of the date of service. CERs, patient listings and forms shall be sent to the WWHP in a manner that is HIPAA compliant; protecting patient confidentiality at all times electronically, utilizing a Secure File Transfer Protocol (SFTP). No physical delivery of paper bundles or patient information shall be delivered to ADHS:

6.1.3.1 Documentation for Personnel and ERE costs shall be submitted with each CER on which Personnel and ERE reimbursement is requested. The documentation shall include: staff name, rate, hours, total pay and total ERE charged. The total for all staff shall be equal to what is listed on the CER;

6.1.3.2 Documentation for Other Expenses shall include copies of invoices where the total matches the amount billed; and

6.1.3.3 Documentation for Indirect Costs shall detail how they are determined. Annually the Indirect Agreement shall be provided to the ADHS WWHP Director and Program Manager.

6.1.4 Final CER billing shall be received by the Program Director and Program Manager no later than fifteen (15) days after the end of the budget period/program year. Reimbursement shall be denied for any outstanding claims submitted beyond that date,

6.1.5 All WWHP Contractor Program Coordinators and their Quality Improvement Managers shall be required to attend the ADHS WWHP quarterly educational series meetings, virtually or in person. Travel expenses shall be covered, at state rates, and supported in the Contractor’s WWHP budget. Travel expenses shall not exceed amount limits set by the State of Arizona and claims shall conform to standards established by ADHS. Documentation shall be maintained in Contractor’s files for audits. Documentation shall also be submitted to ADHS when a travel expense is listed on the CER. The Contractor’s Program Managers, coordinators, and staff are held accountable for understanding the information shared at the meeting, OF HEALTH SERVICES

150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

6.1.6 Contactor shall be required to attend semi-annual administrative and program check-in meetings virtually and report progress on screening targets,

6.1.7 Contactor shall be required to fill out and submit quarterly program reports, failure to do so shall affect future funding,

6.1.8 Contractor shall be required to increase screenings by five percent (5%) annually per the CDC requirement, and

6.1.9 The Contractor shall document plans and performance as described in tasks 6.1.1 to 6.1.8 using Program authorized reporting formats.

6.2 Tracking and Reporting

It is the Contractor’s responsibility to track and report the operational and financial information. It is the Contractor’s responsibility to observe screening rates, spending ratios and spending limits based on the following:

6.2.1 The Contractor shall closely track the application of funds and shall maintain an internal accounting system that indicates the real-time totals of payments and the balance of unexpended funds for each cost component of the program and for each of the funding sources. The Contractor shall not exceed budgeted amounts and agrees to notify ADHS WWHP ninety (90) days prior to any depletion of budgeted funds. The Contractor shall use at least ninety-five percent (95%) of budgeted funds, failure to meet the ninety-five percent (95%) spending threshold shall result in decreased funding available in subsequent Contract years,

6.2.2 Rates of performance, expressed in the budget of this Contract as the number of clients to be screened, are obligatory. In signing the Offer and Acceptance, the Contractor agrees to achieve the stated screening number and recognizes that an anticipated failure to do so shall result in withdrawal of funding, and

6.2.3 Within thirty (30) days of Contract award the Contractor shall report to ADHS their facility baseline screening rates for breast and cervical cancer. If this is done via a chart audit, the audit shall be conducted on the appropriate number of relevant charts to ensure that it is statistically significant for their clinic population. Requirements include the following:

6.2.3.1 The Contractor shall complete the Baseline Clinic Data Collection Forms (Breast &

Cervical Clinic Based Annual Reporting System (B&C BARS) for breast and cervical cancer annually. The breast cancer baselines shall be created for two population sets;

those fifty to seventy-four (50 to 74) years for breast and those twenty-one to sixty-four (21 to 64) years for cervical. (This form shall be provided by ADHS);

6.2.3.2 The Contractor shall complete the NBCCEDP Health System EBI Implementation Plan

Guide, and Template following a program assessment, (The Clinic Review Guide and Template from the CDC shall be provided by ADHS);

6.2.3.3 ADHS shall provide an EBI Clinic Review Tool to the Contractor after award; and

6.2.3.4 The Contractor shall assure that expenditures for costs incurred in screening and diagnostics procedures are not duplicated in payments of salaries or employee-related expenses for personnel who conduct those same procedures.

6.3 Screening, Diagnostic and Treatment Services shall include the following:

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150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

6.3.1 The Contractor shall provide breast and cervical cancer screening services with timely and appropriate diagnostic and treatment services in accordance with service and reimbursement policies set forth by the Program Manual, the Clinical Guidelines and algorithms provided by ADHS, and the Medicare Reimbursement Schedule. It is the Contractor’s responsibility to:

6.3.1.1 Provide WWHP services to enrolled clients directly or through Contracts with qualified service Providers;

6.3.1.2 Ensure that clients enrolled in WWHP are not charged for covered services; and

6.3.1.3 Navigate insured clients through screening, diagnostic and, if necessary, treatment services.

6.3.2 Reimbursement rates are set in accordance with Medicare Part B allowable rates. New rates are effective every year, and once available, distributed by the Program Manager at ADHS. A listing of maximum reimbursement rates is provided to the Contractor by ADHS each year,

6.3.3 Patient navigation services are reimbursed for insured patients at the Contractor clinic at the flat rate of fifty-five dollars ($55) per patient navigated. Navigation shall be completed in full (dependent on the individual needs of the patient) in order to be reimbursed. Navigation Only patients shall be reported on the WWHP Client Listing and included in monthly CER and bundle submissions, and

6.3.4 The Contractor shall implement a case management system to assess the need for case management for abnormal screening results and provide timely and appropriate follow-up as defined in the WWHP and CDC guidelines. To assure quality in case management, the Contractor shall comply with the following:

6.3.4.1 The time from abnormal screening result to complete diagnosis shall be sixty (60) or fewer calendar days for all cases. If this time frame is not met, services shall not be reimbursed; and

6.3.4.2 The time from diagnosis to treatment start for breast cancer and invasive cervical cancer shall be sixty (60) or fewer calendar days for all cases. The time from diagnosis to treatment start for cervical lesions requiring treatment shall be sixty (60) or fewer calendar days for all cases. If this time frame is not met, services shall not be reimbursed.

6.4 Claims for reimbursement of allowable expenses shall be submitted by the following categories:

6.4.1 CLIENT TRANSPORTATION. The Contractor shall coordinate and provide transportation for clients, if necessary, to screening and to diagnostic appointments. Transportation expenses are reimbursed at AHCCCS rates. Documentation shall be submitted with the CER billing for that service. Supporting documentation shall be maintained in the Contractor’s files for audits,

6.4.2 DIRECT CLIENT (PATIENT CARE) SERVICES. The Contractor shall report all expenses related to WWHP screening and diagnosis. Supporting documentation shall be attached to the monthly CER. Documentation includes MDEs and all related items. Services costing $200.00 or more require that a copy of the original invoice be included, or

6.4.3 NON-CLIENT COSTS. Documentation related to administrative and travel expenses shall be submitted with the CER and also shall be retained in the Contractor's offices and available on

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150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007 demand to representatives of ADHS WWHP and to program auditors. For the purposes of this Contract, documentation pertains to sales receipts and any other form of invoices for purchases of goods or services, documentation related to compensation of personnel and employment-related costs, documentation for public education expenditures, documentation for staff travel expenditures (mileage log and receipts for travel-related expenses), and receipts for all other administrative costs. Contractor shall keep documentation and receipts on file at the Contractor offices, and these shall be made available on demand to representatives of ADHS WWHP and to program auditors. All non-client costs billed on the CER shall have supporting documentation submitted with the CER.

6.5 Covered services shall include:

6.5.1 Screening Services

6.5.1.1 Breast – annual screening mammography for clients forty to sixty-four (40 to 64) years old. It is not a requirement for every client to have a Clinical Breast Exam (CBE) prior to a mammogram. Reimbursement is allowed for a CBE, but it is not required. The decision to have a CBE shall be between a client and her provider. Diagnostics following an abnormal CBE or mammogram follow the Breast Cancer Diagnostic Algorithms shall be provided to the Contractor by ADHS upon award of a Contract. In addition:

6.5.1.1.1 Clients thirty-five to sixty-four (35 to 64) years old shall be assessed for their lifetime breast cancer risk. Contractor shall use either the Gail Model or Tyrer-Cuzick risk assessment tool to determine risk. Risk assessment results shall be reported to ADHS WWHP as an MDE, and

6.5.1.1.2 Those clients determined to be at high risk may have a magnetic resonance image (MRI). Requests for approval of an MRI shall be submitted to the WWHP offices at ADHS.

6.5.1.2 Cervical - the pelvic examination and the Pap test shall be done in accordance with the WWHP Clinical Guidelines and the CDC guidance provided in the National Breast and Cervical Cancer Early Detection Program Manual (provided by ADHS upon award). This guidance changes periodically and the Contractor shall be responsible for keeping protocols, process and algorithms in step with the CDC guidelines.

Guidance for cervical screening algorithms can be found at the ASCCP guidelines. To be eligible for Pap test screening:

6.5.1.2.1 Clients shall have an intact cervix or history of cervical neoplasia,

6.5.1.2.2 Cervical Cancer screening shall be for clients aged twenty-one to sixty-four (21 to 64) years old, regardless of sexual activity,

6.5.1.2.3 Clients shall receive a Pap test alone every three (3) years for those aged twenty-one to twenty-nine (21 to 29) years. For those aged thirty to sixty-four (30 to-64) years, funds can be used to reimburse for either 1) Pap testing alone every three (3) years, 2) co-testing with the combination of Pap testing with human papillomavirus (HPV) testing every five (5) years for those aged thirty to sixty-four (30 to 64) years, or 3) primary HPV testing every five (5) years. Clients under the age of twenty-one (21) are not eligible to patriciate in the program. Pap testing provided outside of these https://www.asccp.org/guidelines

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150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007 timeframes or age ranges shall not be reimbursed unless clinically warranted,

6.5.1.2.4 Clients twenty-one to sixty-four (21 to 64) shall be assessed for their overall risk for cervical cancer. Risk assessments results shall be reported to ADHS WWHP as an MDE. There shall be a space on the WWHP form specific to reporting the risk determination,

6.5.1.2.5 Clients considered high risk (HIV positive, immunocompromised, and exposed in utero to diethylstilbestrol) may need to be screened more often and shall follow the recommendations of their provider,

6.5.1.2.6 Clients who have had a hysterectomy for invasive cervical cancer shall undergo cervical cancer screening for twenty (20) years even if it goes past the age of sixty-five (65). Clients who have had cervical cancer shall continue screening indefinitely as long as they are in reasonable health,

6.5.1.2.7 Contractor shall focus their efforts on screening a minimum of thirty five percent (35%) of program eligible clients who have never been screened for cervical cancer or who have not been screened within the past ten (10) years,

6.5.1.2.8 If CDC changes program screening guidance Contractor shall reflect the guidance as requested by ADHS and CDC, and

6.5.1.2.9 For follow-up testing after abnormal Pap results, Contractor shall provide diagnostic testing as per the ASCCP guidelines.

6.6 The target population for Navigation Only services shall be predominately low-income clients at or below

250% FPL, insured clients between the ages of twenty-one to sixty-four (21 to 64) years receiving services from the Contractor’s clinic shall be enrolled in the WWHP to receive patient navigation and case management for their breast and cervical cancer screening and diagnostic procedures. While these clinical services shall not be reimbursable by the WWHP and shall be covered by the client’s insurance, patient navigation shall be reimbursed to the Contractor at the flat rate of fifty-five dollars ($55) per patient.

MDEs shall be submitted to ADHS WWHP on Navigated Only patients. Patient navigation for clients served in the WWHP shall include the following activities:

6.6.1 A written assessment of the client’s barriers to cancer screening, diagnostic services, and initiation of cancer treatment,

6.6.2 Patient education and support,

6.6.3 Resolution of client barriers (i.e. transportation and translation services),

6.6.4 Patient tracking and follow-up to monitor progress in completing screening, diagnostic testing, and initiating cancer treatment,

6.6.5 Patient navigation shall include minimum of two (2), but preferably more, contacts with the patient, given the centrality of the client-navigator relationship, shall include:

6.6.5.1 Collection of data to evaluate the primary outcomes of patient navigation;

6.6.5.2 Patient adherence to cancer screening;

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150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

6.6.5.3 Diagnostic testing;

6.6.5.4 Treatment initiation; and

6.6.5.5 Patients lost to follow-up shall be tracked.

6.6.6 Linking clients to other needed health, community, and social services,

6.6.7 Patient navigation services are terminated when a client:

6.6.7.1 Completes screening and has a normal result; and

6.6.7.2 Completes diagnostic testing and has normal results; or

6.6.7.3 Initiates cancer treatment or refuses treatment.

6.6.8 Diagnostic services: Covered diagnostic services are reimbursed in accordance with amounts listed by ADHS WWHP in the annual Fee Schedule of the Medicare Reimbursement Rates for allowed procedures,

6.7 The Contractor shall implement a case management system to assess the need for case management for abnormal screening results and monitor timely and appropriate follow-up as defined in the WHHP and CDC guidelines. To assure quality in case management, the Contractor shall comply with the following:

6.7.1 The time from screening to diagnosis shall be less than sixty (60) calendar days,

6.7.2 For all breast cancer and all invasive cervical cancer, the time from diagnosis to treatment shall be less than sixty (60) days. For all High Grade Squamous Intraepithelial Lesion (HSIL), Cervical Intraepithelial Neoplasia, Grade ll (CIN2), Cervical Intraepithelial Neoplasia, Grade lll (CIN3), and Cervical Cancer in situ, the time from diagnosis to treatment shall be less than sixty (60) days, and

6.7.3 Clients diagnosed with breast or cervical abnormalities are followed using the WWHP guidelines and the algorithms discussed above. If a case appears complex, the WWHP Medical Directors are available to provide technical assistance and guidance. The case records are submitted to the WWHP Program Director or WWHP Program Manager. ADHS staff is responsible for communicating with the Medical Director. If additional information is requested by the Medical Director, the Contractor is responsible for providing that information to ADHS within forty-eight (48) hours.

6.8 The Contractor shall coordinate the submission of BCCTP application packets to ADHS WWHP Program

Director or Program Manager. The Contractor shall guide the patient in the BCCTP Enrollment Application process. Application packets shall include: pathology report showing a diagnosis of breast cancer, cervical cancer, or pre-cancerous cervical lesions (CIN II or CIN III); BC-100 Form; WWHP Demographic and Eligibility Form; AHCCCS Application; copies of Arizona driver’s license, social security card, U.S. Birth Certificate or Legal Permanent Resident card with at least five (5) years of legal residency;

and documents demonstrating proof of current gross household income;

6.9 The BCCTP was expanded on August 2, 2012. This expansion allows uninsured clients in Arizona, with an income at or below 250% of the Federal Poverty Level, diagnosed with breast or cervical cancer on or after August 2, 2012 to enroll in the BCCTP. The process for this enrollment can be found on the Breast and Cervical Cancer Treatment page of the wellwomanhealthcheck.org website. Contractor is http://azdhs.gov/hsd/healthcheck/wellwoman/bcctp/index.htm

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150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007 responsible for educating local providers and organizations about the expansion and the process for enrolling these Community Referrals into the BCCTP. Contractor shall use the materials available on the website for this education process. Contractor is also responsible for coordinating the submission of these packets for their site(s). The Contractor is required to process Community Referral applications for BCCTP for the geographic area in which they are providing services; and

6.10 Contractor shall link patients diagnosed with breast or cervical cancer to survivorship services as listed on the survivorship page of wellwomanhealthcheck.org. The annual work plan shall include a description of survivorship resources available in the community and how the clinic plans on linking patients with those resources. The case manager shall show cancer patients the tab specific to survivorship care plans and explain how those are to be used.

7. QUALITY ASSURANCE

7.1 The Contractor and Service Providers shall respond within forty-eight (48) hours to communications concerning quality assurance issues. Consider any request for patient information or data a quality assurance issue;

7.2 Lost to follow-up for abnormal results is defined as not being able to contact a client for follow-up services or even to inform of results. Lost to follow-up cases shall not be closed as lost to follow-up until the appropriate WWHP procedures have been executed and documented in the patient’s chart, and until a copy of the special form to report lost to follow-up has been sent to ADHS in the appropriate MDE bundle submission. A client cannot be declared lost to follow-up unless significant documented efforts have been made to locate the client. Contractor shall supply documentation of at least four (4) attempts to follow-up with the patient. The four attempts shall consist of three (3) telephone calls and one (1) certified letter. The return receipt or returned letter shall be filed in the patient’s medical record. A copy of the receipt shall accompany the lost to follow-up form submitted to ADHS;

7.3 Quality standards shall include:

7.3.1 The Contractor and all subContractor shall obtain and maintain the following current documents: license(s) or certification(s) and liability insurance. The Contractor shall maintain a secured file of all such documents that shall be available for review at any time,

7.3.2 Personnel: All Medical Doctors (MDs) or Doctors of Osteopathy (DOs) providing services under this Contract shall be AHCCCS providers and currently licensed under the provisions of the Arizona Revised Statutes, Title 32, Chapter 13 or 17. All other personnel providing services shall be registered, licensed, or board certified in Arizona in their respective fields, as applicable. Indian Health Service providers are not required to have Arizona licenses, and

7.3.3 Facility: To be approved for payment, all mammography reports shall be submitted using the language of the American College of Radiology (ACR) lexicon, also known as BI-RAD System™. All laboratory facilities used by the Contractor and its subContractor shall adhere to the standards of the Clinical Laboratory Improvement Act (CLIA) (1988), and maintain the appropriate CLIA certification. To be approved for payment, all Pap test reports shall be submitted using the current Bethesda System of reporting.

7.4 Service Provider Contracts shall grant the Contractor and ADHS WWHP representatives, access to review WWHP patient records, and policy and procedure statements. Review is necessary to monitor compliance with WWHP protocols and to manage clinical quality. Provider Contracts shall require that all cancer cases be submitted to the ACR by the diagnosing provider within ninety (90) days of diagnosis;

https://www.azdhs.gov/prevention/tobacco-chronic-disease/cancer-prevention-control/cancer-survivors/index.php http://www.wellwomanhealthcheck.org/

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150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007

7.5 WWHP patient records shall be maintained by Service Providers for up to ten (10) years to ensure patient care. After ten (10) years, the patient records may be destroyed in a manner consistent with HIPAA regulations;

7.6 Each Contractor is responsible for ensuring that the Contractor and all subContractor provide the Program

Director with legible copies of procedure reports/results in addition to properly completed WWHP MDEs;

and that Service Providers understand and follow clinical guidelines and program policies/procedures;

7.7 Sub-Contracts with clinicians (breast and cervical) shall be with AHCCCS registered Service Providers.

In the event a client’s diagnostic work-up is positive for cancer or pre-cancerous cervical lesions, and the client’s treatment is received through AHCCCS, AHCCCS shall cover the cost of treatment and diagnostic procedures. By sub-Contracting with AHCCCS registered Service Providers, AHCCCS can pay the Service Provider directly for the diagnostic services rendered;

7.8 Assessment of the client’s smoking status shall occur during each annual visit. If the patient is a current smoker the patient shall be referred to the ASHLine Smoking Cessation call in system. Referral forms shall be provided. Smoking status shall be recorded on the Demographic and Enrollment Form; and

7.9 The WWHP is a screening, diagnostic, and quality improvement program. Due to the Quality

Improvement focus of the WWHP, each Contracted entities Quality Improvement Manager shall attend the ADHS WWHP quarterly educational series meetings.

8. PARTNERS AND COALITION BUILDING:

The Contractor is responsible for participating in coalitions and/or partnerships focused on improving services or access to services for breast and cervical cancer issues. To accomplish this, the Contractor shall:

8.1 Participate in local meetings of groups, organizations, and agencies such as, but not limited to, the

American Cancer Society, the Arizona Cancer Coalition, ethnic and cultural coalitions, and health care coalitions. The purpose of this participation is to establish and maintain local networking opportunities for identifying treatment opportunities and enhance public awareness of breast and cervical cancer resources;

8.2 Engage in planning activities that support the American Cancer program activities. Contractor shall also participate in these local events;

8.3 Actively participate in a work group with the Arizona Cancer Coalition. Work groups are project focused and change over time. The focus of all work groups is to lower the burden of cancer in Arizona while improving the quality of life for cancer survivors and their families. Contractor shall report work group selection in their quarterly report;

8.4 Educate local providers and organizations about the BCCTP expansion and the process for enrolling these Community Referrals into the BCCTP. Contractor shall use the materials available on the website for this education process. Contractor is responsible for coordinating the submission of these packets for their site(s). The BCCTP was expanded on August 2, 2012. This expansion allows uninsured clients in Arizona, with an income at or below 250% of the Federal Poverty Level, diagnosed with breast or cervical cancer on or after August 2, 2012 to enroll in the BCCTP. The process for this enrollment can be found on the Breast and Cervical Cancer Treatment page of the wellwomanhealthcheck.org website;

and

8.5 Assess their community for healthy lifestyle programs and activities targeting adults (examples include the Chronic Disease Self-Management Program, Diabetes Self-Management Program and the LIVESTRONG program at the Young Men’s Christian Association [YMCA]). A list of these resources shall http://azdhs.gov/hsd/healthcheck/wellwoman/bcctp/index.htm

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150 N. 18th Avenue, Suite 530 Phoenix, Arizona 85007 be submitted in the annual work plan.