BREAST AND CERVICAL CANCER CONTROL NAVIGATION PROGRAM MEDICAL PROTOCOL OCTOBER 2018

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1 1 TABLE OF CONTENTS I. Introduction page 2 II. BCCCNP Clinical Services Provided to Eligible Clients - page 3 III. BCCCNP Age and Insurance Eligibility to Receive Breast and Cervical Cancer Screening and/or Diagnostic Services page 4 IV. Clinical History and Breast/Cervical Examination page 4 V. Patient Education page 5 D. Special Considerations: Breast Cancer Screening Transgender women (M > F) page 6 E. Special Considerations: Cervical Cancer Screening Transgender men (F > M) page 7 VI. Client Notification of Test Results page 7 VII. Breast and Cervical Cancer Screening Test Recommendations page 8 A. Table 1: Breast Cancer Screening Recommendations for Women at Average Risk page 8 B. Table 2: Breast Cancer Screening Recommendations for Women at Increased Risk page 9 C. Table 3: Cervical Cancer Screening Recommendations for Women at Average Risk page 11 D. Table 4: Cervical Cancer Screening Recommendations for Women at Increased Risk page 11 E. Table 5: Pap test Follow-up Based on Client History page 12 VIII. Clinician Guidelines for Follow-up of Breast/Cervical Cancer Screening Results page 13 A. Table 6: Follow-up of Clinical Breast Exam Screening Results for Women age 25 page 14 B. Table 7: Follow-up of Screening Mammogram Results for Women age 25 page 15 IX. Reimbursement of BCCCNP Screening and Diagnostic Services page 16 Appendix A Reimbursement Policies - Breast Cancer Screening/Diagnostic Procedures page 17 Appendix B Reimbursement Policies - Cervical Cancer Screening/Diagnostic Procedures page 21 BCCCNP 1

2 2 I. INTRODUCTION Guidelines in this protocol are to be used to provide care to Breast and Cervical Cancer Control Navigation Program (BCCCNP) women receiving breast and cervical cancer screenings and follow-up care BCCCNP funds cannot be used for the time and materials needed to assess and manage problems unrelated to breast or cervical cancer. Approval for reimbursement of breast and/or cervical services not described in this protocol need to be obtained from the MDHHS Nurse Consultant prior to the client receiving the service. The BCCCNP s Breast Cancer Advisory Committee (BCAC) and the Cervical Cancer Advisory Committee (CCAC) promote the use of national breast and cervical cancer screening and follow-up recommendations as part of the BCCCNP Medical Protocol. The breast clinical protocol is based upon screening guidelines developed by the American Cancer Society (ACS 2015, ), the US Preventative Services Task Force (USPSTF 2016, and the National Comprehensive Cancer Network (NCCN) Breast Cancer Screening and Diagnosis Guidelines (V , For follow-up of abnormal clinical breast exam (CBE) and/or mammogram results, the BCAC promotes the use of the NCCN Clinical Practice Guidelines Breast Cancer Screening and Diagnosis Guidelines (V ), The cervical clinical protocol is based upon screening guidelines developed by the ACS, the USPSTF, and the American Society for Colposcopy and Clinical Pathology (ASCCP 2014, 2018). For follow-up of abnormal Pap test results, the CCAC promotes the use of the ASCCP 2014 Updated Consensus Guidelines for Managing Abnormal Cervical Cancer Screening Tests and Cancer Precursors. Guidelines are referenced in this document and may be found at QUESTIONS REGARDING THIS PROTOCOL MAY BE DIRECTED TO: E.J. Siegl, RN OCN, MA, CBCN, BCCCNP Director/Nurse Consultant 517/ or siegle@michigan.gov Julie Hammon, MSN, RN, OCN, BCCCNP Nurse Consultant 517/ or hammonj@michigan.gov Washington Square Building Cancer Prevention and Control Section, 109 Michigan Ave, WSB - 5 th Floor, Lansing, MI Revised 2018 BCCCNP 2

3 3 II. BCCCNP CLINICAL SERVICES PROVIDED TO ELIGIBLE CLIENTS The BCCCNP provides breast and cervical cancer screening and/or diagnostic services to program eligible women to confirm or rule-out a breast or cervical cancer diagnosis. A. Screening Services Provided by the BCCCNP 1. Definition: Screening is the attempt to detect unsuspected disease in average risk, asymptomatic women. 2. Breast cancer screening recommendations a. Women age at Average Risk for Breast Cancer: Annual screening mammogram (Refer to Table 1) b. Women age at High-Risk for Breast Cancer: Screening recommendations based on a woman s risk factors Refer to Table 2 3. Cervical cancer screening recommendations: a. Women age 21-29: (Refer to Table 3) Pap test alone every 3 years b. Women age 30-64: ANY of the following is acceptable (Refer to Table 3) Pap test alone every 3 years OR HPV -HR (primary HPV testing ONLY) every 5 years OR Pap/HPV co-test every 5 years c. Women age at High Risk for Cervical Cancer: Screening recommendations based on a woman s risk factors Refer to Tables 4 and 5 B. Diagnostic Services Provided by the BCCCNP 1. BCCCNP women identified with abnormal breast and/or cervical cancer screening results are referred for appropriate diagnostic follow-up procedures to confirm or rule out a cancer diagnosis. (See Appendix A and B) 2. Refer to the BCCCNP Unit Cost Reimbursement Rate Schedule for a list of diagnostic procedures approved for reimbursement. BCCCNP UNIT COST REIMBURSEMENT RATE SCHEDULE. C. Cancer Treatment 1. The BCCCNP cannot pay for cancer treatment. 2. In the event a breast or cervical cancer is diagnosed, all BCCCNP enrolled women are assisted in obtaining necessary breast or cervical cancer-related treatment in a timely manner. 3. Women meeting the BCCCNP eligibility criteria may also be eligible to enroll in a special Medicaid program for cancer treatment. Refer to BCCCNP MTA Enrollment policy for eligibility criteria. BCCCNP 3

4 4 III. BCCCNP AGE AND INSURANCE ELIGIBILITY TO RECEIVE BREAST AND CERVICAL SCREENING AND/OR DIAGNOSTIC SERVICES A. Uninsured/underinsured women < 250% Federal Poverty Level and between the ages of are eligible to receive the following program approved services: 1. Cervical cancer screenings: Pap test and/or HPV test (based on age) 2. Cervical cancer diagnostic tests: For follow-up of an abnormal Pap test and/or HPV test 3. Breast cancer diagnostic tests: For follow-up of an abnormal breast finding, mammogram, and/or ultrasound. B. Uninsured/underinsured women < 250% Federal Poverty Level and between the ages of are eligible to receive the following program approved services: 1. Breast and cervical cancer screening tests 2. Breast and cervical cancer diagnostic tests for follow-up of a breast or cervical screening abnormality IV. CLINICAL HISTORY BREAST AND CERVICAL EXAMINATION A. Clinical history should consist of the following: 1. Breast Cancer Screening History a. Description of current breast symptoms (if any) b. History of breast problems (abnormal CBEs, abnormal mammograms, breast biopsies, results of biopsies) c. Last mammogram date and result d. Family history of breast/ovarian/colorectal cancer (both maternal and paternal, including age at diagnosis). e. Personal risk factors that increase a woman s risk for getting breast cancer (See Table 2) 2. Cervical Cancer Screening History a. Description of current gynecological symptoms (if any) b. History of cervical cancer screening, including abnormal Pap test results c. Last Pap test date and result d. Hysterectomy history (if applicable), and reason for hysterectomy e. Personal risk factors that increase her risk of getting cervical cancer (See Table 3) 3. Smoking History a. Assess past, current, number of packs per day, and duration. b. Assess readiness to quit smoking. c. Provide resources to help with tobacco cessation. See smoking cessation guidelines. BCCCNP 4

5 5 B. Physical Exam as indicated (all are included as part of the Clinical Encounter) 1. Clinical Breast Examination 2. Pelvic Exam 3. Obtain Pap test (if indicated as per recommendations in Table 3) C. Mammography Screening 1. Order the appropriate mammogram based on clinical breast exam findings and/or client history: a. Screening Mammogram - performed on an asymptomatic woman to detect early, clinically unsuspected breast cancer. b. Diagnostic Bilateral Mammogram - performed on a woman with clinical signs or symptoms that suggest breast cancer or history of a breast cancer or abnormality that requires ongoing monitoring. 2. Request copy of mammogram report. Review report to determine appropriate follow-up per radiologist s recommendations. 3. Mammography Screening Based on Breast Density a. Breast Density Definition: the ratio of fat to fibro glandular tissue in the breast. b. Breast density has a two- fold effect on mammographic screening: High breast density is known to result in decreased mammographic sensitivity for the detection of breast cancer. Women with dense breasts are at moderately increased risk for breast cancer compared to women of average breast density. Patients with heterogeneously or extremely dense breasts are notified of this result from the radiologist and the possible need for additional imaging. See c. The NCCN, USPSTF, ACS, ACOG, ACR do not recommend routine supplemental screening for women with dense breasts without other risk factors since such screening has not been shown to result in a decrease in mortality. d. If supplementary screening is desired, preliminary evidence suggests that MRI is more sensitive than ultrasound for cancer detection. Pre-approval for MRI is required by a MDHHS Nurse Consultant prior to the MRI being performed. V. PATIENT EDUCATION A. Clinical Encounter: Review physical exam findings with client 1. Clinical Breast Exam a. Discuss findings and need for follow-up if abnormal. BCCCNP 5

6 6 b. Discuss Breast Self- Awareness: Emphasize that any time a woman detects a breast change or a palpable mass she should seek evaluation from a health care provider. 2. Pelvic Exam a. Discuss components of the pelvic exam, including whether a Pap and/or HPV test is performed, and whether the woman is being tested for sexually transmitted infections. b. Discuss abnormal cervical signs/symptoms that require provider notification and possible evaluation. NOTE: Given the recommended increase in cervical cancer screening interval, strong consideration should be given to providing women with copies of their Pap test/hpv test results. 3. Discuss the importance of obtaining regular breast and cervical cancer screenings at the appropriate intervals as recommended. B. Discuss limitations of screening procedures in detecting cancer 1. Normal results on a screening exam do not necessarily indicate absence of disease. 2. No screening test is 100% accurate; therefore, some cases of the disease may be unavoidably missed. 3. Normal results never rule out the later development of the disease, which is why regular screening is so strongly recommended. 4. The detection of an abnormality does not mean the abnormality is cancerous. C. Discuss BCCCNP limitations regarding reimbursement of services Inform the client that: 1. Not all BCCCNP screening and diagnostic services are paid by the program. 2. Providers may order additional screening and follow-up tests which are either not reimbursed by BCCCNP or not related to a breast or cervical problem. 3. Clients may be responsible for charges incurred for services not paid by the program. D. Special Considerations: Breast Cancer Screening Transgender women (male to female) 1. Transgender women (male-to-female) who have taken or are taking hormones and meet all program eligibility requirements are eligible to receive breast cancer screening and diagnostic services through the BCCCNP. Screening and diagnostic services (if needed) will be reimbursed by the program. 2. Although there are limited data regarding the risk for breast cancer among transgender women, evidence has shown that long term hormone use does increase the risk for breast cancer among women whose biological sex was female at birth. 3. While CDC does not make any recommendation about routine screening among this population, transgender women are thus eligible under federal law to receive BCCCNP 6

7 7 appropriate cancer screening. 4. CDC recommends that grantees and providers counsel all eligible women, including transgender women, about the benefits and harms of screening and discuss individual risk factors to determine if screening is medically indicated. E. Special Considerations: Cervical Cancer Screening for Transgender men (female to male) 1. Transgender men (female-to-male) who still have a cervix should receive cervical cancer screening per protocol for initiation, cessation, and frequency of screening. 2. Transgender men (female-to-male), whether or not they still have breasts, should have a CBE. If breast tissue is present, screening mammogram should be considered. VI. CLIENT NOTIFICATION OF TEST RESULTS A. Each local coordinating agency should develop and implement an agency specific policy/protocol that describes how the client will be notified of test results and procedures for tracking clients who require follow-up. B. This protocol should include the process for notifying and tracking clients with the following test results: 1. Normal breast or cervical screening results: a. Continue screening recommendations as per program guidelines or provider recommendation. 2. Results requiring short-term follow-up (6 months or less): a. The need for short-term follow-up based on test result b. Date of follow-up exam/test. 3. Results requiring immediate follow-up (< 2 months): a. Discuss the need for further testing to provide a definitive diagnosis to confirm or rule out a cancer or pre-cancerous condition. b. Assist the client with scheduling/referring for appropriate follow-up 4. Inability to Contact Clients with Abnormal Test Results a. Each local coordinating agency should develop an agency-specific protocol that describes the procedure to follow if a client is unable to be contacted regarding abnormal test results. b. The protocol should include: Contacting the woman by telephone and/or sending a certified letter Total number of times the agency will initiate the contact Documentation of the attempted contact(s) in the medical record and in the Michigan Breast and Cervical Information System (MBCIS) data base. BCCCNP 7

8 8 VII.BREAST AND CERVICAL CANCER SCREENING TEST RECOMMENDATIONS A. Table 1: Breast Cancer Screening Recommendations for AVERAGE Risk Women Agency Recommendation Exam Interval Age to Begin Additional Information NCCN (2018) Screening Mammogram (Consider tomosynthesis) ACS (2015) S (Strong Recommendation) Q (Qualified Recommendation) USPSTF (2016) Clinical Breast Exam (as part of the *Clinical Encounter) Screening mammogram CBE Screening Mammogram CBE Annual >40 Clinical encounter (Includes ongoing risk assessment/risk reduction counseling and Clinical Breast Exam) Breast awareness (women should be familiar with their breasts and promptly report changes to their health provider 1-3 years Annual >40 A clinical breast exam alone is NOT considered breast cancer screening. Annually (S) Yearly exams should continue for as long as a woman is in good health and life expectancy > 10 years Biannual or Annual (Q)) 55 Women should have the opportunity to begin annual screening between the ages of 40 and 44 years. Not NA recommended Biennial B rating: The USPSTF recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial Not recommended Personal decision when to start and how often C rating: The decision to start regular, biennial screening mammography before the age of 50 years should be an individual one and take patient context into account, including the patient's values regarding specific benefits and harms. Insufficient evidence No recommendation Insufficient evidence No recommendation BCCCNP 8

9 9 B. Table 2: Breast Cancer Screening Recommendations for Women at Increased Risk for Breast Cancer (NCCN 2018) Breast Risk Factors Exam Interval Age to Begin Personal History of Breast Cancer CBE Annual Post Diagnosis Prior thoracic radiation therapy between ages of (Current age > 25 Y) Women who have a lifetime risk > 20% as defined by models that are largely dependent on family history (e.g. Claus, BRCAPRO, BOADICEA, Tyler-Cuzick) Consider referral to genetic counselling if not already done Women >/= 35 with 5-year Gail Model risk of invasive breast cancer >/= 1.7% Women who have a lifetime risk > 20% based on history of LCIS or atypical ductal or lobular hyperplasia Mammogram Annual Clinical Encounter (to 6-12 Begin 10 years after Radiation Therapy include CBE) months Screening Mammogram Annual Begin 10 years after Radiation Therapy but not prior to age 30 y Consider tomosynthesis MRI Annual Begin 10 years after Radiation Therapy but not prior to age 25 y Clinical Encounter 6-12 Begin when identified as being at increased risk (to include CBE) months Screening Mammogram- Annual Begin 10 years prior to the youngest family member but not prior to 6 months apart from age 30 MRI (Consider tomosynthesis) MRI 6 months apart Annual Begin 10 years prior to youngest family member but not prior to age from mammogram 25Y CBE 6-12 Begin when identified as being at increased risk by Gail Model months Screening Mammogram Annual Consider tomosynthesis CBE 6-12 Begin post diagnosis LCIS or ADH/ALH months Screening Mammogram Annual Begin post diagnosis LCIS or ADH/ALH but not prior to age 30 y Consider tomosynthesis BCCCNP 9

10 10 Breast Risk Factors Known Genetic predisposition (i.e. BRCA1/2, p53, PTEN) or other gene mutation. Exam Interval Age to Begin MRI (consider) Annual Begin post diagnosis LCIS or ADH/ALH but not prior to age 25 y CBE 6-12 Age 25 months Mammogram consider Annual > Age 30 tomosynthesis MRI Annual > Age 25 Additional Information 1. All recommending societies recognize the benefit of regular mammography screening for breast cancer. 2. All women should be familiar with the known benefits, limitations, and potential harms associated with breast cancer screening. 3. Breast Awareness: Women should be familiar with how their breasts normally look and feel and report any changes to a health care provider right away BCCCNP 10

11 11 C. Table 3: Cervical Cancer Screening Recommendations for Women at Average Risk for Cervical Cancer (ASCCP 2012) Age to Begin Exam Interval Additional Information Age Pap test alone Every 3 years HPV testing is unacceptable for screening women ages years Age Pap test alone OR Every 3 years Upper Age Limit for Screening Women aged older than 65 years: If evidence of adequate negative prior screening* and NO history of HPV-HR test alone OR Pap test and HPV- HR co-test Every 5 years Every 5 years CIN2+ within the last 20 years women should not be screened for cervical cancer with any modality Once screening is discontinued, it should not be started for any reason, even if a woman reports having a new sexual partner. *Adequate negative prior screening is defined as 3 consecutive negative cytology results or 2 consecutive negative co-tests within the 10 years before ceasing screening, with the most recent test occurring within the past 5 years. D. Table 4: Cervical Cancer Screening Recommendations for Women (21 and older) at Increased Risk for Cervical Cancer (ASCCP 2012) Risk Factor Exam Interval Additional Comments Prior history of CIN or cervical cancer Prior DES exposure Immunosuppression for other causes HIV/AIDS infection Organ transplantation Pap test (alone) Pap test (alone) annually for 3 years. If normal, Pap/HPV Co-test every 3 years BCCCNP 11

12 12 E. Table 5: Pap test Follow-up Based on Client History (ASCCP 2012) Client History Follow-up Recommendation (regardless of age) Biopsy History: CIN 1 (preceded by ASC-US or LSIL) Annual Pap/HPV Co-test at 12 months Biopsy History: ASC-H: Annual Follow-up ASC-H: Co-test Pap/HPV at 12 months CIN 1 (preceded by ASC-H or HSIL) CIN 1 (preceded by ASC-H or HSIL) HSIL- Immediate Follow-up HSIL: Diagnostic LEEP within 90 days (Pre-approval by MDHHS Nurse Consultant required) Biopsy History: Routine Screening after Routine screening x 20 years: CIN 2 or CIN 3/CIS followed by treatment treatment Pap test every 3 years OR Pap/HPV co-test every 5 years (Table 3) (Treatment may include: LEEP, Conization, (CIN 2, CIN 3/CIS) or hysterectomy (CIN 3/CIS) NOTE: Screening for cervical cancer past age 65 may be indicated. Hysterectomy for invasive cervical cancer (CERVIX PRESENT OR NOT) Women whom the reason for the hysterectomy or final diagnosis of no neoplasia (CIN 2, CIN 3/CIS) or invasive cancer cannot be documented. Hysterectomy for cancer OTHER than cervical (E.g. endometrial, ovarian) Routine screening indefinitely if the woman is in good health Routine screening No Pap test indicated. Pap test (alone) annually for 3 years. If normal, then Pap/HPV Co-test every 3 years Routine screening x 10 years: Pap test every 3 years OR Pap/HPV co-test every 5 years (Table 3) Screening with vaginal cytology is NOT indicated; this does not preclude a pelvic exam. BCCCNP 12

13 13 VIII. CLINICIAN GUIDELINES FOR FOLLOW-UP OF BREAST/CERVICAL CANCER SCREENING RESULTS A. Breast follow-up of normal and abnormal CBE Results (Clients > 25) (Table 6). See NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis (V ) B. Breast follow-up of normal and abnormal Mammogram/Ultrasound Results (Clients > 25) (Table 7) See NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis (V ) C. Cervical screening recommendations and follow-up (Clients > 21) based on Pap test/hpv results, and Pap test adequacy. See Algorithms: Updated Consensus Guidelines for Managing Abnormal Cervical Cancer Screening tests and Cancer Precursors. D. Indications for Referral to a Qualified Colposcopist: 1. Women age 24 and under requiring colposcopy 2. Women with a significant cervical lesion in which see and treat may be indicated. 3. Women desiring fertility who, after excisional treatment, have recurrent or persistent cervical dysplasia. 4. Women who have had two unsatisfactory for evaluation Pap tests 2-4 months apart 5. Women with AGC or AIS on cytology. BCCCNP 13

14 14 A. Table 6: Follow-up of Clinical Breast Exam Screening Results for Women Age 25 CBE Result Type of Followup Recommendation 1. Normal/Benign Finding (Normal glandular tissue felt upon palpation) No Follow-up Required Refer for Screening Mammogram 2. Abnormal Exam: Suspicious for Cancer (May include any of the following: a. Lump or Mass b. Asymmetric Thickening/Nodularity c. Skin or nipple changes (Peau d orange, erythema, nipple excoriation, scaling, eczema, skin ulcers) Immediate Follow-up (within 60 days) to confirm or rule/out cancer Refer for Diagnostic Mammogram AND Additional follow-up procedures as indicated (E.g. Ultrasound, Surgical Consult, Biopsy, etc). See NCCN Clinical Practice Guidelines in Oncology for Breast Cancer Screening and Diagnosis (V ) 3. Abnormal Exam: Nipple Discharge Follow-up based on color of discharge and spontaneous vs. non-spontaneous Spontaneous Discharge Unilateral, single duct and clear or colorless, serous, sanguineous or serosanguineous Persistent and reproducible on exam Spontaneous Discharge: Immediate Follow-up (within 60 days) to confirm or rule/out cancer a. Spontaneous Nipple Discharge for women > age 25 Refer for Surgical Consult Ductogram, possible Duct Excision Possible MRI b. Non-spontaneous or multi-duct discharge for women years of age: observation only BCCCNP 14

15 15 B. Table 7: Follow-up of Screening Mammogram Results for Women age 25 Mammogram Result Type of Follow-up Recommendation ACR 1 Negative No Follow-up Annual screening unless CBE is abnormal. If CBE abnormal, additional diagnostic follow-up (BEYOND THE MAMMOGRAM) is required ACR 2 Benign Breast Condition No Follow-up Annual screening unless CBE is abnormal. If CBE abnormal, additional diagnostic follow-up (BEYOND THE MAMMOGRAM) is required ACR 3 Probably Benign ACR 0 Assessment is Incomplete ACR 4 Suspicious Abnormality ACR 5 Highly Suggestive of Malignancy Short-term Follow-up (6 months) Immediate Follow-up for additional work-up/imaging (mammogram and/or ultrasound) (within 60 days) Immediate Follow-up (within 60 days) to confirm or rule/out cancer Refer for diagnostic mammogram and/or ultrasound (ultrasound for women under age 30) based on radiologist recommendations. Radiologist recommendations for type of imaging at 6- month follow-up Refer for diagnostic mammogram and/or ultrasound (ultrasound for women under age 30) based on radiologist s recommendation. Based on result, additional referral to a breast surgeon/ specialist for evaluation may or may not be indicated. Refer for surgical consult and biopsy BCCCNP 15

16 16 IX. REIMBURSEMENT OF BCCCNP SCREENING AND DIAGNOSTIC SERVICES A. Due to limited program funding, and CDC policy restrictions on the type of screening and follow-up tests that may be reimbursed by the program, the BCCCNP may not be able to reimburse for all recommended follow-up testing according to the ASCCP or NCCN management guidelines. (Refer to Appendix) B. As part of yearly contract renewals with BCCCNP providers, BCCCNP coordinators should discuss the program s limitations regarding covered and non-covered program services provided to enrolled women. C. Any questions regarding coverage for BCCCNP services should be directed towards one of the MDHHS clinical or reimbursement staff PRIOR to the service being performed to determine if the service will be reimbursed by the BCCCNP. BCCCNP 16

17 17 Appendix A BCCCNP Reimbursement Policies for Breast Cancer Screening and Diagnostic Procedures The MI BCCCNP reimburses for the following services for uninsured/underinsured women < 250% FPL based on her history and clinical presentation: Women age 40 64: Can receive breast cancer screening and diagnostic services Women age 25-39: Can receive breast cancer diagnostic services Mammography Modality BCCCNP will reimburse for film, digital, and 3-D mammography (tomosynthesis) up to the Medicare reimbursement rate. All women should be counseled on the benefits and risks of mammography. If a woman has the option of having a 3-D mammography, she should be counseled on the benefits and risks of 3-D mammograms versus 2-D mammograms to make an informed decision. Breast Services Supporting Information BCCCNP Reimbursement Screening Mammography Priority population for BCCCNP mammography services is UNINSURED women Screening Mammogram (AVERAGE RISK) women between the ages of 50 and 64. every 1-2 years Screening Mammography (HIGH RISK) women A minimum of 75% of all BCCCNP-reimbursed screening mammograms provided to average risk women should be to those who are 50 years of age and older. Beginning 1/1/2019, all BCCCNP newly enrolled women will undergo a risk assessment to determine if they are at high risk for breast cancer. BCCCNP funds can be used for annual breast cancer screening among women who are considered at high-risk for breast cancer. (NOTE: This includes women UNDER age 40) Annual Screening Mammogram and MRI* (ideally scheduled q 6 months apart) *Requires Nurse Consultant approval Refer to BCCCNP medical protocol for risk factors identifying women at increased risk for breast cancer. Screening Mammography Post cancer treatment, eligible women can be enrolled in BCCCNP to receive services. Annual Screening BCCCNP 17

18 18 Breast Services Supporting Information BCCCNP Reimbursement (Women with history of breast Mammogram cancer) Follow-up of these women will be based on their providers assessment. Screening Mammography (Women > age 65) Mammography (Women < age 40) Mammography (Transgender Women) Women 65 and older who are eligible to receive Medicare benefits should be encouraged to enroll in Medicare. Women enrolled in Medicare Part B are not eligible for the BCCCNP. Women who are not eligible to receive Medicare Part B and Medicare-eligible women who cannot pay the premium to enroll in Medicare Part B are eligible to receive mammograms through the BCCCNP. Mammograms provided to these women will be counted in the 75% minimum. BCCCNP can reimburse for a mammogram to be used to evaluate women under age 40 who are symptomatic for abnormal breast findings. A woman can be provided a clinical breast examination, diagnostic mammogram, ultrasound, and/or a surgical consultation. Transgender women (male-to-female), who have taken or are taking hormones and meet all program eligibility requirements, are eligible to receive breast cancer screening and diagnostic services through the NBCCEDP. Providers should counsel all eligible women, including transgender women, about the benefits and harms of screening and discuss individual risk factors to determine if screening is medically indicated. Annual Screening Mammogram (as long as client meets program eligibility criteria) Mammogram and other diagnostic procedures as ordered. MRI requires prior approval by Nurse Consultant Mammogram every 2 years Beginning at age 50 OR 5-10 years of feminizing hormone use have been taken BCCCNP 18

19 19 Breast Services Supporting Information BCCCNP Reimbursement If an individual has a particular body part or organ and otherwise meets criteria for screening based on risk factors or symptoms, screening should proceed regardless of hormone use Magnetic Resonance Imaging BCCCNP will reimburse for screening breast MRI performed in conjunction with a mammogram when: Client has been identified at increased risk for developing breast cancer per criteria in the medical protocol Used for diagnostic follow-up to better assess areas of concern on a mammogram Used for evaluation of a client with a history of breast cancer after completing treatment MRI requires prior approval by Nurse Consultant Mammography (Men) Ultrasounds (all women) Breast MRI cannot be reimbursed when: Performed alone as a breast cancer screening tool Performed right after the diagnosis of breast cancer to assess the extent of disease for staging to determine treatment modality Per Public Law , men are not eligible to receive BCCCNP screening and/or diagnostic services. Ultrasounds are used for diagnostic evaluation and may be performed: On the same day as a screening mammogram to confirm a finding found on the mammogram. As immediate follow-up to a screening mammogram result of ACR 0: Assessment is Incomplete to identify the type of NEW abnormality As a short-term follow-up within a 12-month time period (<365 days) or post biopsy as per radiologist recommendation NOTE: Ultrasound may be the primary imaging modality used for women < age 30 to evaluate a breast abnormality due to dense breasts No services reimbursed Ultrasound for diagnostic evaluation in conjunction or as follow-up to a mammogram finding. BCCCNP 19

20 20 Breast Services Supporting Information BCCCNP Reimbursement Imaging Tests PRE-Biopsy Ultrasound will be reimbursed separately from biopsy ONLY if used to determine if abnormality still present prior to performing biopsy Ultrasound performed prior to Ultrasound guided biopsy (performed on same day) Ultrasound will NOT be reimbursed if performed as part of a provider s routine practice prior to performing biopsy Reimbursed if used to determine evidence of biopsy prior to performing biopsy Imaging Tests POST-Biopsy Post Breast Biopsy mammogram/ultrasound imaging for: clip placement and/or to determine specimen adequacy Reimbursed as ordered Biopsy of skin, subcutaneous To rule out inflammatory breast cancer Reimbursed as ordered tissue an/or mucous membrane Excisional procedure: Breast To rule out Paget s disease Reimbursed as ordered nipple exploration, with or without excision of a solitary lactiferous duct or a papilloma lactiferous duct Ultrasound: Axilla To determine a cystic mass from a solid mass. Reimburse as ordered Axillary Node Biopsy Mammary Ductogram or Galactogram AND Incision Injection procedure (only) for mammary Ductogram/Galactogram If performed to confirm or rule/out breast cancer diagnosis in absence of abnormal mammogram If performed for unilateral bloody, serous or serosanguineous discharge. Contact MDHHS Nurse Consultant to determine if service can be reimbursed Contact MDHHS Nurse Consultant to determine if service can be reimbursed BCCCNP 20

21 21 Appendix B BCCCNP Reimbursement Policies for Cervical Cancer Screening and Diagnostic Procedures The MI BCCCNP reimburses for the following services for uninsured/underinsured women < 250% FPL based on her history and clinical presentation: a. Women age years: Pap testing ALONE every 3 years b. Women age Pap test alone every 3 years OR Pap/HPV Co-test every 5 years c. Routine Cervical cancer screening is defined as: Pap test alone every 3 years OR Pap/HPV Co-test every 5 years UNLESS OTHERWISE SPECIFIED UNDER REIMBURSEMENT. Cervical Services Supporting Information BCCCNP Reimbursement Pap test (AVERAGE RISK women) Priority population for BCCCNP mammography services is UNINSURED women who have NEVER received a Pap test. Routine screening A minimum of 20% of all BCCCNP-reimbursed screening Pap tests should be provided to program-eligible women who have NEVER been screened for cervical cancer. Pap test (HIGH RISK women) Reimbursement denied if Pap test performed prior to Client Eligible for Pap Test Date in MBCIS unless approved by MDHHS Nurse Consultant. Beginning 1/1/2019, all BCCCNP newly enrolled women will undergo a risk assessment to determine if they are at high risk for cervical cancer. BCCCNP funds can be used for routine cervical cancer screening among women who are considered at high-risk for cervical cancer. (NOTE: This includes women UNDER age 40) Refer to BCCCNP medical protocol for risk factors identifying women at increased risk for cervical cancer. Routine screening for HIGH-RISK women is defined as: Annual Pap test x 3 years. If normal, Pap/HPV cotest every 3 years. BCCCNP 21

22 22 Cervical Services Supporting Information BCCCNP Reimbursement Pap test for women > 64 years of age Cervical cancer screening is not recommended for women older than 65 years of age who have had adequate screening and are not high risk. Routine screening Cervical Cancer Screening Following Hysterectomy or Other Treatment for Cervical Neoplasia or Cancer Women enrolled in Medicare Part B are not eligible for the BCCCNP. If a woman over 64 needs to be screened and is eligible to receive Medicare benefits but is not enrolled, she should be encouraged to enroll. Women who are not eligible to receive Medicare Part B and Medicare-eligible women who cannot pay the premium to enroll in Medicare Part B are eligible to receive cervical cancer screening through the BCCCNP 2. Women who have had hysterectomies performed because of a pre-cursor to cancer (CIN 2, CIN 3/CIS) and DO NOT have a cervix 3. Women who have had hysterectomies performed because of INVASIVE cervical cancer (CERVIX PRESENT OR NOT) 4. Women whom the reason for the hysterectomy or final diagnosis of no neoplasia (CIN 2, CIN 3/CIS) or invasive cancer cannot be documented. Routine screening X 20 years Routine screening indefinitely if the woman is in good health Routine screening X 10 years 5. Women who have had a hysterectomy, but it is unknown if she has a cervix. Reimbursement for Office Visit for pelvic examination HPV DNA Testing HPV-HR testing is reimbursable alone as a screening test for women age Reimburse as ordered HPV DNA testing is reimbursable when used for screening (CoTest with Pap test) or follow-up (reflex HPV test) of abnormal Pap results as per ASCCP algorithms. HPV genotyping is reimbursable when used for follow-up of abnormal cervical cancer screening results as per ASCCP algorithms. Providers should specify the high-risk HPV DNA panel only. Low-risk HPV DNA panel is not reimbursable. BCCCNP 22

23 23 Cervical Services Supporting Information BCCCNP Reimbursement High Risk - HPV test may be performed alone (without Pap test) as 12-month follow-up of colposcopy High Risk (HR) HPV tests performed as immediate follow-up for ASC-US Pap to determine follow-up or as part of diagnostic work-up for AGC test result Transgender men Transgender men (female to male) under the age of 21 should not have Pap tests regardless of age of sexual debut. Routine screening Cervical cancer screening should never be a requirement for testosterone therapy. Cervical cancer screening for transgender men, including interval of screening and age to begin and end screening follows recommendations for non-transgender women as endorsed by the American Cancer Society, American Society of Colposcopy and Cervical Pathology (ASCCP), American Society of Clinical Pathologists, U.S. Preventive Services Task Force (USPSTF) and the World Health Organization. LEEP/Cold Knife Conization (Includes anesthesia reimbursement) Pap smears on transgender men have a ten-fold higher incidence of an unsatisfactory result compared to non-transgender women, which is positively correlated with length of time on testosterone. Diagnostic LEEP/Cold Knife Conization is indicated for Pap test results of HSIL followed by a colposcopy with biopsy result of not cancer, atypia, CIN 1 or unsatisfactory colposcopy Diagnostic LEEP/Cold Knife Conization requires pre-approval by MDHHS Nurse Consultant BCCCNP 23

24 24 Cervical Services Supporting Information BCCCNP Reimbursement Endometrial Biopsy (EMB) (for women with AGC Pap result only) Management and follow-up of AGC or Adenocarcinoma in Situ (AIS) a. In women < 35 years of age with an AGC cytology result, an endometrial biopsy should be performed in the presence of, but not limited to, the following conditions: EMB requires preapproval by MDHHS Nurse Consultant (Includes anesthesia Dysfunctional uterine bleeding reimbursement) At risk for chronic anovulation A change in menstrual flow b. In women 35 years of age or older Initial Evaluation: Colposcopy with endocervical sampling (ECC) is recommended for women with all subcategories of atypical glandular cells (AGC) (AGC not otherwise specified [NOS], AGC favor neoplasia ) and adenocarcinoma in situ (AIS) Management of women with initial AGC or AIS by repeat Pap testing is unacceptable and will NOT be reimbursed by the program. Triage of AGC Pap results with HR-HPV is unacceptable Subsequent Evaluation or Follow-up: If biopsy-confirmed CIN is identified during the initial workup of a woman with AGC (NOS), the woman should be referred to a qualified colposcopist for treatment. If invasive disease is not identified during the initial colposcopic workup, it is recommended that women with AGC favor neoplasia or endocervical AIS undergo a cold-knife conization or LEEP. BCCCNP 24