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Acknowledgments Follow-Up and Treatment Issues in Funding for this study was from the Centers for the National Breast and Cervical Disease Control and Prevention, Division of Cancer Prevention and Control Cancer Early Detection Program The study was designed and implemented by a team of investigators from Battelle Centers for Study Results Public Health Research and Evaluation and the University of Michigan School of Public Health January, 1998 Research Team Goals of the Study Battelle Centers for Public Health Research University of Michigan To document strategies and methods used by and Evaluation: School of Public Health: states to obtain follow-up diagnostic services not covered by NBCCEDP funds. Lowell Sever, Ph.D. Paula Lantz, Ph.D. To document strategies and methods used by Martha Hare, Ph.D. Lisa Richardson, M.D., M.P.H. states to obtain treatment services for clients Cartyn Orians, M.A. Deb Macklem, M.Ed. diagnosed with CIN or cancer. Jane Schulman, Ph.D. To identify strategies that are perceived as successful or innovative in securing diagnostic and treatment resources. Flow of Follow-Up and Treatment Activities Research Questions Focus of Case Study What guidelines, policies or methods have been State Breast and developed and implemented by states to ensure Cervical Cancer Scroming Early Detection Diagnosis Treatment that women with abnormal screening results and Program women diagnosed with cancer or precancerous lesions receive diagnostic follow-up and treatment services? How is the component of the program that Identifies and secures diagnostic and treatment Strategies to help Strategies to help ensure that weeke casure that women services organized? obtain diagnostic lesse 1) gain access to they used treatment What role do coalitions or other partnerships play? n receive treatment Research Questions Phases of the Study Have the methods or tactics being used to identify Phase I: Core set of data on 35 programs and secure diagnostic and treatment resources changed with time, and do they differ within the Phase II: In-depth case study of 7 states individual state programs or across programs? What are the key lessons learned regarding Phase III: Linkage study (in process)-Tumor diagnostic and treatment services in a program such as the NBCCEDP? registry data and program data from 3 states (CA, MI, NM) were linked to document timing of treatment initiation and initial course of cancer treatment What is a Case Study? Conducting a Case Study A case study seeks to understand the way in which a Determine Select Sinn, Criteria for program, system, or organization works within its Projects I Events for everyday setting Cases is Data Develop the Study Collection it focuses on a particular problem, issue, or structure Ectoblish Quastions 8 Model which is studied in relationship to the larger program, to be of Program Design Data Answered Conduct Collection system, or organization Through Data lastruments Research Collection While describing this relationship, the case study may or may not lead to conclusions about outcomes Performs Propose Develop Date A case study uses all appropriate sources of Date Case Study Analysis Plan Analysis Report evidence - written, observational, and interview - that may be analyzed both qualitatively and quantitatively Case Study Selection Criteria Case Study States Provided screening for at least three years State Number of Breast Region Cancers Diagnosed Diagnosed 60 or more breast cancers since California 168 West screening began Michigan 249 Midwest Representative of the following stratification Minnesota 137 Midwest criteria: New Mexico 169 West Centralized versus decentralized programs Geographic region of United States New York 173 Northeast Urban/rural mix of the population North Carolina 106 South Racial and ethnic diversity among program clients Texas 307 South How Did We Conduct the How Did We Conduct the Case Study? Case Study? Contacted the coordinator for each of the seven Interviewed State BCCEDP Coordinator and programs to schedule site visits, and to obtain other staff who work with diagnosis and background information treatment issues Reviewed documents supplied to us by the state Interviewed local coordinators and providers program, such as organizational tables, reports in a variety of settings throughout the state and articles Interviews were tape recorded, transcribed, Traveled to each state and briefed state BCCEDP and entered into a word processing database staff regarding the project at the beginning of each state's site visit How Did We Analyze the Data and Write How Did We Analyze the Data and Write the Case Study State Summaries? the Case Study State Summaries? The Project PI and the Case Study Coordinator Using the analyzed transcripts, a member of the developed a codebook based on the research site visit team developed a state summary questions in the Case Study Protocol Each member of the site visit team reviewed the Using the codebook, the PI and Coordinator state summary worked together to achieve 80% inter-rater The summary was then sent to state program agreement on the use of codes for text, and then staff and other interviewees for review trained one other team member Reviewer feedback was incorporated into a All interviews were coded and entered into a text revised state summary analysis software Number of Interviews Case Study Results by State and Role Site visits were conducted February-June, 1997 TOTAL CA MI MN NM NY NC TX A total of 126 interviews were conducted State staff 58 13 4 11 4 9 10 -7 A total of 192 people were interviewed Local staff 15 2 2 2 4 4 . - Screening 60 3 6 8 5 7 U 8 provider Dx or Tx provider 45 7 4 9 3 3 13 6 Advisory Board\ 10 2 . I J I 2 I Coalition member Other 4 - . 1 2 . 1 . TOTAL 192 27 16 12 21 24 49 23 Strategies Used to Ensure Provision of Strategies Used to Ensure Provision of Diagnostic and Treatment Services Diagnostic and Treatment Services Common Approaches at the Local Level: Common Approaches at the State Level: Bill insurance Assist clients in applying for Medicaid, Hill Burton Clients followed through use of tracking and funds, other assistance programs follow-up systems Referral to public hospital Requirements in contracts with providers Charity care, donated services Appeals to providers through state medical Case rotation societies, professional associations, etc. Reduced fees Negotiated payment plans Clients pay fee for service Additional Strategies Used by States General Findings Across States Blue Cross Foundation treatment fund CA* States have found supplemental funds (primarily for breast cancer diagnostic services) Race for the Cure fund MN* Women diagnosed with cancer who want to be State breast cancer programs NY* treated are receiving treatment Other state funds TX*, NC Strong reliance on providers to find resources Tobacco excise tax fund CA*, MI Follow-up handled on case-by-case basis Providers of last resort NM, TX County indigent funds NM, TX funds used for breast services only General Findings Across States Strengths Women who need and want cancer treatment are Solutions, strategies and networks are tenuous receiving it and fragile Creative responses and strong partnerships have Programs operate within changing health care emerged at state, local and provider level environments (i.e. growth of managed care) Availability of state or foundation funds to Information lacking for many important issues: supplement Federal resources -payment source for diagnostic and treatment services -out-of-pocket expenses for women -impact of financial barriers on time delays/refusals Strengths Areas of Concern Centralized tracking systems work well Lack of financial support for diagnosis and treatment Program has had positive effect on tracking and Time and energy required for follow-up is tremendous follow-up in larger community Burden of follow-up has led to restrictions in number of women screened Several barriers to provider recruitment: - low reimbursement rates (mendated by Congress) - lack of coverage for all diagnostic follow-up services - liability for treatment - administrative burden of follow-up Areas of Concerns Areas of Concern Some women experience time delays or are lost to follow-up Categorical nature of program prohibits a more (especially in regard to cervical services) comprehensive approach to women's health A small number of women have refused cancer treatment Financial access is only one dimension of access to Coordinating diagnostic follow-up is greater burden than health care services. Many non-financial barriers arranging treatment impede follow-up care: Resources states have developed are short-term solutions, - logistical barriers (e.g. transportation, scheduling) and difficult to manage/administer - cultural barriers (e.g. language barriers, fatalistic attitudes, fear) - immigration issues Recommendation key Respondent Recommendations Conclusions of Case Study Program should pay for all diagnostic and treatment Strong response to provision of diagnostic follow-up services, or at least through definitive diagnosis and treatment services has emerged Allow state resources used for all diagnosis and Wide range of strategies is employed within states; treatment services to be counted in the 3:1 match effort at local level is tremendous Cover anesthesia and other affiliated services Responses that have emerged are administratively Increase reimbursement rate for services covered cumbersome and unstable; long-term solutions are Increase support for case management and community needed infrastructure Strong commitment to continued growth and success Universal health insurance of the NBCCEDP exists at state and local level Linkage Study - Linkage Study - Research Questions Research Questions What proportion of women identified through What are the components (surgery, radiation, selected states' BCCEDPs as having breast chemotherapy, hormonal therapy) of the or cervical cancer did not receive an initial initial course of cancer treatment for women course of treatment, based on registry identified through the BCCEDPs as having records? breast or cervical cancer? What characteristics of women and their cancers What characteristics of women and of their are associated with not receiving treatment? cancers are associated with the content of the initial course of treatment? Linkage Study - Linkage Study - Research Questions Research Questions What is the time interval between abnormal How does the information from the program screening and diagnosis? database compare with the corresponding What is the time interval between diagnosis information from the cancer registry database? and treatment? How do women screened through the program What characteristics of women and their cancers compare with all women in the registry with appear to be related to these time intervals? regard to patterns of diagnosis and treatment? Article Strategies for Follow-Up and Treatment Services in State Breast and Cervical Cancer Screening Programs Paula M. Lantz, PhD Lisa C Richardson, MD, MPH Debra I. Macklem, MEd Lisa R Shugarman, BA University or Michigan School or Printic Health Amt Arber, Mistagen Donna B. Knutson, MSEd, CHES Cames for Disease Control and Prevennon, Division or Cancer Prevention and Control Atlanta. Conga Lowell E Sever, PhD Barrette Centers for Public Health Research and Exairation Searte, Washington This report describes strategies used to provide diagnostic follow-up and treatment services to low-income women screened through the National Breast and Ceroical Cancer Early Detection Program. he Breast and Cervical Cancer Morrality Prevention Acr, enacted by T the U.S. Congress in August 1990 (Public Law 101-354) authorized funds for 3 national screening program for breast and cervical cancer for medically underserved women This program-the National Breast and Cervical Cancer Early Detecrion Program or NBCCEDP-is admin- istered by the Centers for Disease Control and Prevention (CDC). The goal of dus large public health initiative is a reduce the morbidity and morrality associated with breast and cervical cancer in the United States. The NBCCEDF is implemented through cooperative agreements with qualifying health agencies that provide free or law-cost screening B uninsured or underinsured low-mcome women, develop and disseminate public and professional education strategies establish qualiry assurance systems, engage . surveillance and evaluation acrivities, and develop coalitions and parmer- ships.² To dare, the health departments of all 50 states, the District of Columbia, 4 U.S. terrimnes, and 15 American Indian and Alaska Native tribes or tribal a 1999 by the jambs Institute organizations have received support for comprehensive Breast and Cervical of Worker's Health Cancer Early Derection Programs (BCCEDPs). The age and income eligibility by Emerge Scance inc 1045-3867/99/320.00 requirements for screening services vary across the programs, but all programs PT 516e9-3867(98)00027-9 42 NOMENS HEALTH SSUES VCL MANUARY/S 21 target high-pricrity groups, for example, older women wemen if racal and sthnic minority groups, women winit disabilities, lesbrans, md :vomen who live III rural or orier hard-to-reach areas. Through September 1997, more than 15 million = mammograms and Papanicoiaou smear TESTS were provided inreugh the NBCCEDP. The ITC- gram aiso covers a number of milow-up diagnostic procedures. including diagnostic mammegraphy, Teast airrasound, surgical consultation, me nee- dle aspirance of the creast ma minoscopy Because #: limited resources, however. program funds have not been available 8 cover 311 or me diagnostic tests that women may need for follow-up of abnormal screening resuirs and P mach 3 defininve diagnosis (mciuding excisional treast biopsy. localizanon for breast ICDSV, II needle core breast bicosy). In addinon, the federal legislation pronibies the use or national program funds to pay for treamment services for women diagnosed with cervical intraepitheual neopiasia (CIN) or for any component of Teachent for breast or cervical including surgery, -adiotherapy. inemotherapy. hormonal herapy. and breast Through September Despire these restrictions in funding diagnosite and creament services are 1997, more than 1.5 recognized as essential components of HIS screening ininadive Federal legic- million free larion requires that participating programs ensure that vomen with abnormal screening resuirs receive definitive diagnoses and that twy have access R mammagrams and timely and appropriate meannent services for CN H ancer if needed, Papanicolaou smear regardless or their ability 9 pay. Parecipating health agencies are expected tests were provided R build coilaterations and parmerships with hospitals and community-based organizations = cotain access B and resources for diagnostic reament. and through the NBCCEDP support services.² Anecdoral information reported 3 CDC suggests that partipating agreem- cies are indeed finding innovarive and interesting warz B secure diagnostic follow-up and Teamment services for wemen in need however. this aspect of the NBCCEDP has not been assessed in depth or systemancilly. Thus. we underrook a three-part study B decument md investigare the strategies and approaches that state BCCEDP, have implemented 9 secure diagnosur follow-up and cancer Treatment service for chenis I the absence or federal dollars for these acriviries: 1) 1 descriptive study of the general scategies and activities regarding diagnostic and readment services at И BCCEDPs: 2) in in-depth case study of 7 or the 35 state programs and 3) documentation of cancer realment services received and the timing H. these services by linking information from 3 state BCCEDPs with dara from oculation-based number regismes. In this report, we present the results from the irst study component METHODS All 35 stare 3CCEDPs that received federal funding in 3 comprehensive screening program before Center 1. 1996 (and thus had significant experience dealing with clients in need of diagnostic follow-up and reaument services) were selected for study. Dara were collected with the assistance of 13 CDC program consultants, who are Adanta-based staff who provide rechnical assistance to and serve as federal haisons with the state programs. A standard- ized dara collection form that consultants could seif-administer as part of their general dunes was designed and nict tested. The form was used 3 document state-specinc information III the organizational SUPPLIERS of the screening program. mechanisms for coufying women of results. md strategies for securing diagnosed and rearnent services for clients in need Written instruc- nons = completing the form and 1 3-hour training session were provided. Consumers completed 1 form in each of mea issigned states in = sample STRATECISS 2 CANCER SCIENING PROCRAMS (rariging from ! R 3 states If. consultant), using their newiedge of the State program and available materials and documents They LISU discussed specific issues in their rourine rechnical assistance ails with states : clarification irom the state program was needed. Completed forms (N = 35: 100% response me) were forwarded R University or Michigan reach statf siong with my relevant written documents. RESULTS One way = which 311 state programs WCIX 3 ensure mar needed failow-up diagnostic :2513 and rearment services are received is by tacking clems using program surveilance dara. State programs have designed and moiemented a variety or management information systems TO no women firough the processes of screening. diagnostic fullow-up, ind Teamment mission In addinen. ar the time of our data collection. most states had WHEN guidenns or protecols for screening providers for nonrying women of. screening results States are required to and for tracking women reeding diagnostic services the in abnormal report to CDC the date screening result (Table 1). in addition 39% or states had Millen guidelines in that cancer treatment ensuring that women receive defininve diagnosue follow-up sen iss. inc 77% had written guidalines for ensuring that weren ininate Teacherr for breast or was initiated for cervical cancer or CN. Similarly, most states had written guidelines or defined breast or cervical cancer. proteccis for providers regarding accropriate clinical cathways for diagnosne follow-up (86% for breast diagnostics and 33% for cervical diagnosues). whereas fewer states had developed proteccis for appropriate treatment pactways (69% for breast cancer. 56% for servical cancer, and 50% for CM. States are required R report = CC the dare that succer meatment was inimared for women diagnosed with breast or cervical cancer Even those states without written guidelines or protecols regarding how women should get, from an abnormal screening result to treatment have implemented surveillance systems that include the Teament inidance date. Some sere programs document addinonal information about treatment For example, cur resuits suggest that 21 stare programs (60%) were routinely documenting each citent's minal course of cancer meanment. and of mese programs. i (23%) were documening the content of Teament beyond the initial course Five stare programs (I+%) were documenting how each client's ancer treatment vas funded, although none were collecting information on our-of-pecker expenses for diagnostic H treatment services. State-level resources used B fund or to provide diagnosne and treatment services R women in the absence or federal program dollars = des activities are listed in Table 2 The more common straregies were appeais through the state medical society for physicians B volunteer or donate procedures and referral of clients B designated providers (such as state-funded cancer centers, teaching hospitals. and public hospitais). Several states receive funding for diagnostic and treatment services from their legisiatures. This inding comes from state appropriations provided through general public revenue = tobacco excise as revenue In some of these states. funds are provided exclusively for women screened through the 3CCEDP, in other states, the funds are available a all ciriZens who meet state-istablished eligibility CHECK for SERVICES. in some states. the funds are restricted B paying for breast cancer services (primarily for diagnostic DSIS). A wide range of strategies and activities organized 18 the local level (in. country. city or individual cirucal facility) were being used B provide diag- nosuc and treatment services = women in the absence of program dollars for these activities (Table 3). The most common strategies used If me iceu level include referrais to designated providers who have agreed = serve program Table L PREVALENCE OF WRITTEN GUIDELINES FOR NOTIFICATION TRACKING. AND SERVICE DELIVERY IN STATE BREAST AND CERVICAL CANCER EARLY DETECTION PROGRAMS (N a 35) Does : Sente Program Have Written Guiddines for Yes No Notifying women of screening results? Breast cancer screening results 32 (91%) 3 (9%) Carvical cancer screening results 32 (91%) 3 (9%) Breast diagnosne est results 31 (89%) +(11%) Cervical cancer diagnosne est nesuits H (89%) 4 (11%) Tracking women needing follow-up services? Breast cancer diagnostic services 35 (100%) a Cervical cancer diagnosue services 34 (97%) 1 (3%) Breast cancer treatment services 32 (91%) 3 (9%) Cervical neopiasia Teament services 32 (91%) 3 (9%) Cervical and Teament services 32 (91%) 3 (9%) Ensuring women receive needed diagnostic services? Breast cancer diagnostic services 31 (89%) 4 (11%) Cervical CHECK diagnostic services 31 (89%) 4 (11%) Ensuring women initiate needed treatment? Breast and treatment services 27 (77%) 3 (23%) Cervical neoplasia reament services 7 (77%) 8 (23%) Cervical SINCE treatment services n (77%) 8 (23%) Defining appropriate pains for diagnosue follow-up and treatment? Breast me diagnosne services 30 (86%) 5 (14%) Cervical cincer diagnostic services 29 (83%) 6 (17%) Breast cancer treatment services 24 (69%) 11 (31%) Cervical negulasia treatment services II (60%) 14 (40%) Carvical cancer Treatment services 3 (66%) 12 (34%) clients for = H at a reduced COST. assistance a clients in applying for Medicaid, or referrals to other government-sponsored insurance programs. Another COMMISSION strategy is the use of funds from local foundations, charitable organizations. or corporate sponsors. Several different strategies that involve clinicians R providers (in hospi- tais. clinics. community health centers, and local health departments) were used R secure diagnosic and treatment services for program chents (Table 3). Many providers donate services or provide other types of charity care, offer services at a reduced fee, negodate payment plans with clients, and write off diagnosne and treatment services as bad debt. In half of the states, a formal or informal system exists for retating referrals for services not covered by program funds among providers in one or more locales. More than is different strategies or activities were named as being used B secure diagnostic and meatment services for BCCEDP clients in need. These strategies. in be order of frequency with which they were named, were 1) reduced fee-icr-service or 3 sliding-fee scale for services. 2) regoriated pay- ment plans between providers and clients; 3) in-kind chantable conmibutions of providers (including hospital indigent care programs); 4) assistance in LANIZ II AL STRATEGIES N CLICER SCIENING PROCEAMS 15 Table 1 USE CF STATE-LEVEL STRATEGIES TO PROVIDE DIAGNOSTIC AND TREATMENT SERVICES IN THE NATIONAL BREAST AND CERVICAL CANCER EARLY DETECTION PROGRAM (N = Number of State Programs Usmg Surangy m Promie. Diagnostic Treatment Strategies Organized major Administered It State Lenei Services City Services Cnty Back Services No.: Used Organization of charity care/m-kind donance 3 (9%) - 15 (43%) V (18%) A. services as state level Referral or clients B state-funded ancer Certify 1 6.5 the (14%) 30 (86%) Referral or chenrs B other designated providers- : (3.0) : (3%) 13 (37%) 20 (57%) who have agreed R serve program Clent assistance in applying for Medicaid or 0 ] IC (29%) 25 (71%) other state program Indian Health Service funds ] 1 8 (23%) my (77%) Race for the Cure funds 5 (L%) : (3%) 1 (3%) 27 (77%) Other Komen Foundation funds 3 (9%) 0 0 32 (91%) Blue Cross Foundation funds ] : (3%) 0 31 (97%) Ceneral public revenue in fund 2 (17%) : 4 (11%) 25 (71%) Tobacco excise as revenue in fund 1 (3%) (3%) 1 (3%) 32(91%) applying R Medicaid or 1 state-sponsored insurance program: E) referral = a designated cancer center or 1 publicly funded medical Sciliry previding indigent care: 6) use of state appropriations for diagnostic or reatment services. If both: and 7) use or funds rmsed through a Susan G Kumen Breast Cancer Foundation Race for the Cure. State programs callaborate with a variety of public and private agencies and organizations in their anempts to bring diagnostic and treatment services a BCCEDP chenrs. Collaboranng agencies mclude state health and human service agencies. county and city health departments, the Indian Health Service, the American Cancer Society, the National Cancer Institute's Cancer Information Service. state and local medical sociecies, state hospital assoca- Table 3. USE OF LOCAL-LEVEL STRATEGIES TO PROVIDE DIAGNOSTIC AND TREATMENT SERVICES IN THE NATIONAL BREAST AND CERVICAL CANCER EARLY DETECTION PROCRAM (N - 35) Number of State Programs Usung Scrangy a Provide Diagnosm Treatment Strategies Organized ma/or Administered at Local Level Services Only Services Only Borts Services Not Used Referral of clients R designated providers 0 0 25 (71%) 10 (29%) Client assistance in spplying for Medicaid or 2 (6%) ! (3%) 22 (63%) 10 (29%) other state program Race for the Cure funds 3 (9%) 0 6 (17%) 26 (74%) Other private coundation funds 3 (9%) a 11 (31%) 21 (60%) Assistance from local American Cancer Society ! (3%) 0 in (14%) 29 (83%) County money in fund 0 0 3 (9%) 32 (91%) -Donation of services or charity care (including 1 (3%) I (3%) 32 (91%) I (3%) meigent care programs) Reduced tee-for-service 2 (6%) 0 27 (77%) 6 (17%) Negotiated payment plan 0 : (3%) 31 (89%) 3(9%) Services written in 15 bad debt ] 0 25 (71%) 10 (29%) System for rotating referrais 1 0 16 (46%) 18 (51%) 16 tions. private foundations. local corporations. churches and synagogues, YWCAs. and community health centers. In Maryland. a centralized response organized at the state level was implemented R ensure mar women screened for breast md servical cancer receive all needed diagnosne and treatment services. In July 1992, the Mary- land legislature allocared funds for ine Maryland Breast and Cervical Cancer Diagnosis and Treatment Program. This program. funded through general public revenue and minacco tax revenue. provides a means by which women an receive free breast and cervical cancer diagnosic ests and reament services. Providers under contract with this fund ofer 1 wide ange of diagnostic and meament procedures for women meering specific sligibility criteria. This state-funded program is not restricted to women screened through the BCCEDF. although the engibility criteria are sumiar By contrast. the Minnesota 3CCEDP does not have access to state funds B supplement the federal program. Rather. the Minnesora program has devel- oped a relationship with the Susan G. Komen Breast Cancer Foundation Race for the Cure in the Twin Cities The majority or the money raised in this annual Multiple strategies are walking/running fundraising event is allocated R the Minnesora 3reast and being used to ensure Cervical Cancer Central Program B pay for breast ultrasounds and curparient that program clients breast biopsies for women throughout the state This strategy involves 1 receive essential parmership between the state health department and a private foundation in an attempt to secure breast diagnostic tests for program clients This strategy, diagnostic and treatment however, does not provide resources for the meanment us breast and cervical services. cancer. or CIN. and in fact. anly half or the breast biopsies received by program clients are paid for through Race for the Cure funds U Korn, personal communication, June 1997). To secure addinonal crucial services for program clients, the Minnesora BCCEDP aiso refers women P Medicaid or Minnesota- Care (a state-sponsored health insurance program for low-income people) and negotiates payment pians. reduced fee-for-service, or charity are for individ- ual cases. DISCUSSION Through the NBCCEDF. low-ncome unmsured and undermsured women receive important clinical preventive services: breast and cervical cancer screening. These women. however. are among those with the fewest resources R pay for diagnostic follow-up DESIS or for Teamment services for 3 subsequent diagnosis of CIN. cervical cancer. or breast cancer. The NBCCEDP's gual a reduce morbidity and mortainy from breast and cervical cancer canner be realized unless women with abnormal screening results receive 1 definitive diagnosis and receive prompt and effectious herapy for cancer or precancer- aus lestons. The NBCCEDP does not cover all the diagnostic services that clients may need. and IT covers no realment costs at all Our study of 35 state screening programs shows that muluple strategies are being used to ensure that program clients receive essential diagnostic and treatment services. Some strategies use centralized funds administered at the state level (eg. State funds appropriated by the legislarure or funds raised through partnerships with private founda- Hons). Other strategies are decemmalized and informal, redecing parmerships and collaborative arrangements that have been worked our as ice level of a community or 1 within 1 single health care instinution. There is great reliance on providers of diagnosur and treatment services R offer NBCCEDP chenrs different types of charity care, reduced in or long-term payment plans. Many of the strategies or approaches in which stare programs rely to provide diagnostic and readment services receive some charge (either full !!! Jr 1 E LV CANCER SCIEENING PROCRAMS 47 reduced in = the cilerit The number at ECCEOP dients charged for follow-up BD and rearment services. = amount of these ciarges, and the degree to which financial barners contribute B = delivs or minsais icr are are not known Approaches providing diagnostic and treatment services vary greativ across states. This is not surprising. given the different socionalitical environ- ments H the states and me different ways in which they have organized H structured their BCCEDPs. Scraces and MMS aiso vary within states Communities and individual facilines WITHIN i state have CS B different resources. and health service delivery systems vary across mens of 3 state Thus local programs within the same state have devised different means or providing diagnostic and Tearment services D THEY dienes. At the Time B this study, some state programs did not have any written guidelines or protocols ior clinical providers for tacking cliens or in ensuring the initiance of follow-up or Teament services. The NBCCEDP sconscred programs are required to have an active medical advisory comminee H consultant that approves clinical protochis/guideimes anc crevides oversight 9 the quality I the services being delivered The = recommends nar NECCEDP sponsored programs use clinical pracence guidenes established bv nationally recognized organizations as a basis ist developing time crotocols for their programs. Some state programs were in the process = designing or approving such guidelines at the time or cur study. The results or this study are limited in several wavs. Ne is not have detailed information regarding me history behind the development of careain policies or the strengths and weaknesses of various Trategies or acts Ne also do not have information regarding me effort If somes required R implement arious strategies cr the efficacy = specific appreaches in addition, winie we have identified 3 wide variety or acrivities that If underway P provide women with diagnostic foilow-up and treatment services, these results do not mil us if women are actually receiving the services they need in a amaly fashion. Yes the results of his study an answer important questions about the NBCCEDP and the need for its paracipating health agences R cirtain resources for some diagnostic tests and for 10 Teament services. This research represents the first systematic !cok at how stare health agencies are working R provide NECCEDP clients the diagnostic and reament services that the program does nor cover. In addition. this study sheds light = how 1 large federal program has been implemented 30 the state are leal levels and how funding restrictions in the federal program have been addressed = innovative ways by collaboraning institutions and organizations. Myriad health agencies and organizations sponsor free or reduced-cost screening programs for 1 diseases other than breast or cervical cancer withour afforing coverage for definitive diagnostic and Teament services. The strategies mi approaches of the 35 state BCCEDPs described here may be useful and relevant B those implementing other types ai disease screening programs ACKNOWLEDGMENTS Lisa C. Richardson, MD. MPH is now with the CDC This project was funded by the CDC Division of Cancer Prevention and Control IFC was incroved by the University of Michigan Health Sciences Human Subjects Review Commit- tee. Rosemarie Henson MSSW. MPH, Stephen Wyar DCM MPS Nancy C Las. MD. Diane Dunet, MPA Jane Schulman, PhD, Martha Hare, PhD. Carlyn Crians. VA and Madelaine Pfanier contributed B = design and implemen- tadon or the project in addinor. the suchors mark = CDC Program Cersultants for their insperation with and = TIS = 18 REFERENCES L The Breast and Cervical Cancer Morrality Prevention Act of 1990. #ZUSCHII erseq 51501-1509 (1990). 2 Henson IM Wyar SW, Las NC The National and Cervical Cancer Early Demenous Program: & comprehensive public hubit response = the majore hunkh issues for women. I Public Health Management Face 1996246-17. 3. US Department of Health and Human Services. The National Breast and Cervical Cause Easly Demenon Program: Airl-Clance 1998. & Reynoids I States. bight. DC-sponsored Income and curvical cancer creaming. I Nad Cancer: Inc 5 Laner PM, Sever LE mail Samagive incomming follow-upand III the nanonal Imme and cervical CRIMER eashy demetion program-United Stane, 1997. MMRW 6 Capian LS. Heiziness KT Delay E buenst cancer: & Deview of the literature Public Health Rev 1993;20.187-214. 7. US. Department of Health and Human Services. The national strategic plan for the easiy detection and commi of breast and cervical cancerel Adams: Centers for Disease Connol and Prevennon, 1994 8 Maraliz M. Odoff TM Desonia R Transforming STATE health agencies B meer CUITERIS and funnoe challenges Washington (DC: National Covernor's Association, 1997 9. Sudmicts L Serverson B. Blais HN. Golay E Richards TB Thorton IN. Analyzing organizational practices B local health organizations. Public Health Rep 1993;109: 485-90. LANIZ = AL STRATEGIES N CANCER SCIEENING PROCZAMS ; Acknowiedgments Follow-Up and Treatment Issues in Funding for this study was from the Centers for Disease Control and Prevention, Division of the National Breast and Cervical Cancer Prevention and Control Cancer Early Detection Program The study was designed and implemented by a team of investigators from Battelle Centers for Public Health Research and Evaluation and the Study Results University of Michigan School of Public Health January, 1998 Research Team Goals of the Study Batteile Centers for Public Health Research University of Michigan To document strategies and methods used by and Evaluation: School of Public Health: states to obtain follow-up diagnostic services not covered by NBCCEDP funds. Lowell Sever, Ph.D. Paula Lantz, Ph.D. To document strategies and methods used by Martha Hare, Ph.D. Lisa Richardson, M.D., M.P.H. states to obtain treatment services for clients Cartyn Orians, M.A. Deb Macklem, M.Ed. diagnosed with CIN or cancer. Jane Schulman, Ph.D. To identify strategies that are perceived as successful or innovative in securing diagnostic and treatment resources. Flow of Follow-Up and Treatment Activities Research Questions Focus of Case Study What guidelines. policies or methods have been State Brunk and developed and implemented by states to ensure Carvant Comm Screaming Diagnosis Transment that women with abnormal screening results and Early Detecmen Programs women diagnosed with cancer or precancerous lesions receive diagnostic follow-up and treatment services? How is the component of the program that identifies and secures diagnostic and treatment Surangies - being Strangies - help - - - - - - services organized? - disgrame - " - - - they - I What role do coalitions or other partnerships play? n reserve - Research Questions Phases of the Study Phase I: Core set of data on 35 programs Have the methods or tacties being used to identify and secure diagnostic and treatment resources changed with time. and do they differ within the Phase II: In-depth case study of 7 states individual state programs or across programs? What are the key lessons learned regarding Phase III: Linkage study (in process)-Tumar diagnostic and treatment services in a program such registry data and program data from 3 states (CA, as the NBCCEDP? MI, NM) were linked to document timing of treatment initiation and initial course of cancer treatment What is a Case Study? Conducting a Case Study A case study seeks to understand the way in which a Describe Secure - Crimine for Projects program. system, or organization works within its beckming Evenue for everyday setting Come . Date I the Study Collection it focuses on a particular problem. issue, or structure Email Quanions . Mindel which is studied in relationship to the larger program, to be 8 I Durage Date Annuared Common Collernon system, or organization Through Due - Research Collection While describing this relationship, the case study may or may not lead to conclusions about outcomes Performs I Develop Date A case study uses all appropriate sources of Date y 1 Amotican Plan Analysis I evidence - written, observational, and interview - that may be analyzed both qualitatively and quantitatively Case Study Selection Criteria Case Study States Provided screening for at least three years State Number of Breast Region Cancers Diagnosed Diagnosed 60 or more breast cancers since California 168 West screening began Michigan 249 Midwest Representative of the following stratification Minnesota 137 Midwest criteria: New Mexico 169 West Centralized versus decentralized programs Geographic region of United States New York 173 Northeast Urban/rural mix of the population North Carolina 106 South Racial and ethnic diversity smong program clients Texas 307 South How Did We Conduct the How Did We Conduct the Case Study? Case Study? Contacted the coordinator for each of the seven Interviewed State BCCEDP Coordinator and programs to schedule site visits, and to obtain other staff who work with diagnosis and background information treatment issues Reviewed documents supplied to us by the state Interviewed local coordinators and providers program, such as organizational tables. reports in a variety of settings throughout the state and articles Interviews were tape recorded, transcribed, Traveled to each state and briefed state BCCEDP and entered into a word processing database staff regarding the project at the beginning of each state's site visit How Did We Analyze the Data and Write How Did We Analyze the Data and Write the Case Study State Summaries? the Case Study State Summaries? The Project PI and the Case Study Coordinator Using the analyzed transcripts. a member of the developed a codebook based on the research site visit team developed a state summary questions in the Case Study Protocol Each member of the site visit team reviewed the Using the codebook, the PI and Coordinator state summary worked together to achieve 80% inter-rater The summary was then sent to state program agreement on the use of codes for text. and then staff and other interviewees for review trained one other team member Reviewer feedback was incorporated into a All interviews were coded and entered into a text revised state summary analysis software Number of Interviews Case Study Results by State and Role Site visits were conducted February-June, 1997 TOTAL CA MI MN NM NY NC TX A total of 126 interviews were conducted State staff $8 13 4 11 4 , 10 7 A total of 192 people were interviewed Local staff 15 2 2 2 4 4 1 Screening 60 J 5 1 5 , U $ provider Dx or Tx provider 45 7 4 9 3 3 13 s Advisory Beard 10 2 1 ) - 2 - Coalition member Other 4 - - I : 1 TOTAL 192 :7 16 32 :1 24 49 23 Strategies Used to Ensure Provision of Strategies Used to Ensure Provision of Diagnostic and Treatment Services Diagnostic and Treatment Services Common Approaches at the Local Level: Common Approaches at the State Level: Bill insurance Assist clients in applying for Medicaid, Hill Burton Clients followed through use of tracking and funds. other assistance programs follow-up systems Referral to public hospital Requirements in contracts with providers Charity care, donated services Appeals to providers through state medical Case rotation societies, professional associations, etc. Reduced fees Negotiated payment plans Clients pay fee for service Additional Strategies Used by States General Findings Across States Blue Cross Foundation treatment fund CA* States have found supplemental funds (primarily for breast cancer diagnostic services) Race for the Cure fund MN* Women diagnosed with cancer who want to be State breast cancer programs NY* treated are receiving treatment Other state funds TX*, NC Strong reliance on providers to find resources Tobacco excise tax fund CA", MI Follow-up handled on case-by-case basis Providers of last resort NM, TX County indigent funds NM, TX funds used for breast services only General Findings Across States Strengths Women who need and want cancer treatment are Solutions, strategies and networks are tenuous receiving it and fragile Programs operate within changing health care Creative responses and strong partnerships have environments (i.e. growth of managed care) emerged at state, local and provider level Information lacking for many important issues: Availability of state or foundation funds to supplement Federal resources -payment source for diagnostic and treatment services -out-of-pocket expenses for women -Impact of financial barriers on time delays/refusals Strengths Areas of Concern Centralized tracking systems work well Lack of financial support for diagnosis and treatment Program has had positive effect on tracking and Time and energy required for follow-up is tremendous follow-up in larger community Burden of follow-up has led to restrictions in number of women screened Several barriers to provider recruitment: - low reimbursement rates (mandated by Congress) - lack of coverage for all diagnostic follow-up services - liability for treatment - administrative burden of follow-up Areas of Concerns Areas of Concern Some women experience time delays or are lost to follow-up Categorical nature of program prohibits a more (especially in regard to cervical services) comprehensive approach to women's health A small number of women have refused cancer treatment Financial access is only one dimension of access to Coordinating diagnostic follow-up is greater burden than health care services. Many non-financial barriers arranging treatment impede follow-up care: Resources states have developed are short-term solutions, - logistical barriers (a.g. transportation, scheduling) and difficult to manage/administer - cultural barriers (a.g. language barriers, fatallatic attitudes, fear) - immigration issues Respondent Recommendations Conclusions of Case Study Program should pay for all diagnostic and treatment Strong response to provision of diagnostic follow-up services, or at least through definitive diagnosis and treatment services has emerged Allow state resources used for all diagnosis and Wide range of strategies is employed within states: treatment services to be counted in the 3:1 match effort at local level is tremendous Cover anesthesia and other affiliated services Responses that have emerged are administratively Increase reimbursement rate for services covered cumbersome and unstable; long-term solutions are Increase support for case management and community needed infrastructure Strong commitment to continued growth and success Universal health insurance of the NBCCEDP exists at state and local level Linkage Study - Linkage Study - Research Questions Research Questions What proportion of women identified through What are the components (surgery, radiation, selected states' BCCEDPs as having breast chemotherapy, hormonal therapy) of the or cervical cancer did not receive an initial initial course of cancer treatment for women course of treatment, based on registry identified through the BCCEDPs as having records? breast or cervical cancer? What characteristics of women and their cancers What characteristics of women and of their are associated with not receiving treatment? cancers are associated with the content of the initial course of treatment? Linkage Study - Linkage Study - Research Questions Research Questions What is the time interval between abnormal How does the information from the program screening and diagnosis? database compare with the corresponding What is the time interval between diagnosis information from the cancer registry database? and treatment? How do women screened through the program What characteristics of women and their cancers compare with all women in the registry with appear to be related to these time intervals? regard to patterns of diagnosis and treatment? CDC March 27, 1998 / Vol. 47 / No. 11 209 Imported Dracunculiasis - United States, 1995 and 1997 MMWR 211 Update: HIV Counseling and Testing Using Rapid Tests - United States, 1995 215 Strategies for Providing Foilow-Up and Treatment Services in the National Breast and Cervical Cancer Early Detection Program - United States. 1997 MORBIDITY AND MORTALITY WEEKLY REPORT 218 World Health Day - April 7. 1998 219 Notices to Readers Imported Dracunculiasis - United States, 1995 and 1997 Dracunculiasis is a parasitic infection caused by a filarial worm (Dracunculus medi- nensis [i.e., Guinea wormi) that is transmitted through contaminated drinking water. Approximately 1 year after a person is infected. one or more meter-long aduit female worms begin to emerge through the skin, often incapacitating the patient for ≥2 months. Despite a dramatic decrease in cases worldwide, dracunculiasis is still occa- sionally imported into the United States. Since 1995, two cases of dracunculiasis have been reported in the United States, both imported from Sudan. This report summa- rizes the investigation of these cases. Patient 1. A 9-year-old girl residing in Tennessee had emigrated from Sudan in Sep- tember 1995 (1). Before the girl left Sudan, a Guinea worm had emerged and had been extracted from her right lower leg. The lesion had healed when she arrived in the United States. After she had been in the United States for 3 weeks, another Guinea worm began to emerge from her left leg. Medical examination at a local health clinic revealed a string-like worm dangling from a lesion on her left leg, and she was re- ferred to an infectious disease specialist. The leg was secondarily infected and swoi- len, and the girl was unable to walk. Despite antibiotic treatment, her cellulitis did not improve, and the lesion was surgically opened. drained, and debrided of pus, necrotic debris, and fragments of the Guinea worm. The patient was hospitalized for 2 weeks. requiring surgery to stretch a contracture of her ankle and to apply a skin graft to the wound. After outpatient physical therapy, she was able to walk without crutches. Patient 2. A 31-year-old woman residing in Connecticut had emigrated from Sudan in January 1997. In April 1997, she was evaluated at a university clinic for possible tuberculosis (TB). A radiograph revealed lung lesions consistent with TB and a worm- like calcification in her left chest. Physical examination revealed multiple, indurated. oval lesions 4-8 cm in diameter on both lower legs. The patient reported the lesions had been present for 1 year and were intermittently painful. She recalled that a long string-like worm had emerged from her leg during the previous year. Biopsy of the leg lesions revealed erythema induratum, consistent with Bazin disease, a cutaneous manifestation of TB. The patient had evidence of a dead and calcified Guinea worm in her chest and a history suggesting a live Guinea worm had emerged from her leg before she arrived in the United States. She also had pulmonary TB with a cutaneous tuberculid skin manifestation. Treatment with isoniazid, rifampin, and pyrazinomide U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Vol. 47 / No. 11 MMWR 215 HIV Counseling and Testing - Continued ing that persons who receive preliminary results understand the meaning of the result and prefer rapid testing (4). When additional rapid tests become available for use in the United States. the PHS will re-evaluate algorithms using specific combinations of two or more rapid tests for screening and confirming HIV infection. References 1. Kamb ML, Bolan G. Zenilman J. et al. Does HIV/STD prevention counseling work? Results from a multi-center randomized trial (Project Respect) (Abstract 01341 In: Program and abstracts of the International Congress of Sexually Transmitted Diseases. Seville, Spain: Association for Research in Clinical Microbiology, 1997:83. 2. CDC. HIV counseling and testing in publicly funded sites: 1995 summary report. Atlanta: US Department of Health and Human Services, CDC, September 1997. 3. George JR, Schochetman G. Detection of HIV infection using serologic techniques in AIDS testing: a comprehensive guide to technical, medical, social, legal, and management issues. 2nd ed. Schochetman G, George JR, eds. New York: Springer-Verlag, 1994. 4. Kassler WJ. Dillon BA, Haley C. Jones WK, Goldman A. On-site, rapid HIV testing with same-day results and counseling. AIDS 1997;11:1045-51. 5. CDC. Interpretation and use of the Western blot assay for serodiagnosis of human immunode- ficiency virus type 1 infections. MMWR 1989;38(suppi 7):S4-S6. 6. Stetler HC, Granade TC, Nunez CA, et ai. Field evaluation of rapid HIV serologic tests for screen- ing and confirming HIV-1 infection in Honduras. AIDS 1997;11:369-75. 7. Kassier WJ, Haley C. Jones WK. Gerber AR, Kennedy EJ. George JR. Performance of a rapid, on-site human immunodeficiency virus antibody assay in a public health setting. J Clin Mi- crobiol 1995;33:2899-902. Strategies for Providing Follow-Up and Treatment Services in the National Breast and Cervical Cancer Early Detection Program - United States, 1997 The Breast and Cervical Cancer Mortality Prevention Act of 1990* authorized CDC to establish the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) to increase screening services for women at low income levels who are uninsured or underinsured (1). Although the NBCCEDP covers most diagnostic serv- ices that women need after receiving an abnormal mammography or Papanicolaou (Pap) test result, the program does not reimburse for breast biopsies. In addition, the Act prohibits the use of NBCCEDP funds for cancer treatment. Participating health agencies must ensure that NBCCEDP clients receive timely, appropriate diagnostic and treatment services. In 1996, CDC began a case study to determine how early de- tection programs in seven participating states (California, Michigan, Minnesota, New Mexico, New York, North Carolina, and Texas) identified resources and obtained diag- nostic and treatment services. This report summarizes the results of the study (2). which indicate that respondents in these states reported that treatment had been initi- ated for almost all NBCCEDP clients in whom cancer was diagnosed. However, re- spondents also considered the strategies used to obtain these services as short-term solutions that were labor-intensive and diverted resources away from screening ac- tivities. In the seven states, NBCCEDP-sponsored screening services had been provided for ≥3 years, and breast cancer had been diagnosed in ≥60 women. The states were se- *Public Law 101-354. 216 MMWR March 27, 1998 National Breast and Carvical Cancer Early Detection Program - Continued lected to provide a range of geographic locations, a combination of urban and rural populations, and racial/ethnic diversity among program clients. Researchers con- ducted semi-structured interviews with 192 persons affiliated with the seven state programs. Of these interviewees, 120 (63%) were providers of screening, diagnostic, and/or treatment services; 58 (30%) were state program staff; and 14 (7%) were coali- tion members. Interviews included topics. such as guidelines related to diagnostic and treatment services, strategies used to obtain and pay for services. level of effort re- quired to secure these services, and changes in strategies over time. Each interview was tape recorded and transcribed. Using a systematic scheme derived from the re- search questions, three researchers coded the same transcripts until an inter-rater agreement of 80% was reached. Thereafter, all transcripts were coded independently. Coding results were entered into text analysis software that sorts text from transcripts into sets of information, themes, and evidence relevant to the specific research ques- tions (3). The results reflect a synthesis of the interviewees' responses. Respondents described several strategies used to ensure necessary diagnostic and treatment services for women screened through the NBCCEDP. State-level strategies in all states included 1) computerized tracking and follow-up systems that used pro- gram surveillance data to identify and manage clients in need of diagnostic and treat- ment services; 2) provisions in contracts requiring screening providers to arrange for diagnostic follow-up and treatment before screening women; and 3) arrangements with provider groups and state professional associations for free or reduced-cost serv- ices for NBCCEDP clients. All states also had access to public or private funds to help support services not covered by the program; such revenue sources included state appropriations from general or tobacco tax revenues or funds from private founda- tions. These funds were available primarily for breast diagnostic services. Local strategies tailored to the needs of individual clients were used to obtain diag- nostic and treatment services. Common strategies reported by respondents included the following: providers billed public or private insurance plans; providers or local health departments helped clients apply for public assistance programs; providers re- ferred clients to public hospitals; county indigent-care funds and hospital community- benefit programs financed services; clients received services through individually negotiated payment plans; and clients paid reduced or full fees for services. Respondents strongly supported the continued growth of NBCCEDP and its goals but expressed several concerns. First, considerable time and effort were involved in developing and maintaining systems for diagnostic follow-up and treatment. Second, the process of identifying available resources within states for diagnostic and treat- ment services was considered labor-intensive. Third, the lack of coverage for diagnos- tic and treatment services negatively affected recruitment of providers and restricted the number of women screened. Fourth, respondents believed that an increasing number of physicians will not have the autonomy, because of changes in the health- care system, to offer free or reduced-fee services to NBCCEDP clients. Respondents reported that arrangements for treatment were made for almost all NBCCEDP clients who received a diagnosis of breast cancer or invasive cervical can- cer. Respondents stated that some women experienced time delays between screen- ing, definitive diagnosis, and initiation of treatment. State program officials reported that, according to 1992-1996 surveillance data, small numbers of clients in whom can- cer was diagnosed (i.e., from three to 13 women in each state) subsequently refused Vol. 47 / No. 11 MMWR 217 National Breast and Cervical Cancer Early Detection Program - Continued treatment. Because these clients were not interviewed, it could not be determined whether financial barriers contributed to their decisions to refuse treatment or their loss to follow-up. Respondents were concerned that the NBCCEDP did not provide funding for all diagnostic procedures and treatment for the diseases for which clients were being screened; approaches for delivering services were fragmented: and the process of ob- taining resources required substantial effort at the state, local, and provider levels. Respondents reported that the continuation of every strategy for diagnostic and treat- ment services beyond the next few years is uncertain. Reported by: PM Lantz, PhD. Univ of Michigan School of Public Health, Ann Arbor. LE Sever, PhD, Battelle, Centers for Public Health Research and Evaluation, Seattle, Washington. Program Svcs Br. Office of the Director, Div of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC. Editorial Note: During July 1991-March 1997, the NBCCEDP provided 576,408 mam- mograms to women aged ≥40 years. and 3409 cases of breast cancer were diagnosed. During this same period, the program provided 732,754 Pap tests; 23,782 cases of cer- vical intraepithelial neoplasia and 303 cases of invasive cervical cancer were diag- nosed. These totals included women referred to the program for diagnostic evaluation of an abnormal screening result. The NBCCEDP internal estimates suggested that dur- ing this period only 12%-15% of uninsured women aged 40-64 years in the United States had been screened by the program (CDC. unpublished data, 1997). Screening alone does not prevent cancer deaths; it must be coupled with timely and appropriate diagnostic and treatment services. The Congressional mandate for NBCCEDP requires grantees to take all appropriate measures to ensure provision of services required by women who have abnormal screening results. CDC provides funds for case management to help these women access health-care services. To in- crease the comprehensive nature of the program, CDC recently approved the use of NBCCEDP funds for breast biopsies. The results of this study indicate that state health departments and their partners in the seven states had developed a wide range of strategies for diagnostic and treat- ment services in the absence of program resources. However, the time and effort re- quired to arrange and maintain these services diverted resources away from screening activities. This study was subject to at least two limitations. First, the results were based solely on the experience and opinions of informed professionals affiliated with the program and did not include the perspectives of NBCCEDP clients. Second, the results may not reflect the program experiences in other states. Case-study methods, how- ever, are an appropriate and well-accepted approach to gaining in-depth under- standing of complex programs in real-life situations (4). The validity of the findings was enhanced by developing standard instruments to guide the semi-structured inter- views, protecting the confidentiality of respondents' remarks, using interview tran- scripts for data analysis rather than relying on interviewer notes, and obtaining feedback concerning state summary reports from respondents. As more women are screened by the NBCCEDP, a greater burden will be placed on participating health agencies, providers, and other partners to obtain resources for breast and cervical cancer treatment. Case-management services will continue to be essential in helping underserved women overcome financial, logistical, and other bar- 218 MMWR March 27. 1998 National Breast and Cervical Cancer Early Detection Program - Continued riers to receiving these services. Other long-term solutions to ensure that women in the program receive necessary treatment services are being pursued. References 1. Henson RM, Wyatt SW, Lee NC. The National Breast and Cervical Cancer Early Detection Pro- gram: a comprehensive public health response to major health issues for women. J Public Health Management and Practice 1996;2:36-47. 2 Lantz PM, Macklem DJ, Hare M, Richardson LC. Sever LE, Orians CE. Follow-up and treatment issues in the National Breast and Cervical Cancer Early Detection Program: results from a multiple-site case study-final report. Baltimore: Battelle, Centers for Public Health Research and Evaluation, 1997. 3. Miles MB, Huberman MA. Qualitative data analysis: an expanded sourcebook. 2nd ed. Thou- sand Oaks, California: Sage, 1994. 4. Yin RK. Case study research: design and methods. Sage: Newbury Park, 1989. Notice to Readers World Health Day - April 7, 1998 "Invest in the Future: Support Safe Motherhood" is the theme in the United States for World Health Day, April 7, 1998. In the United States. this day will focus on the continued importance of maternal health and opportunities to improve this aspect of women's health. Although the risk for women dying from pregnancy has decreased substantially during the past 50 years, the maternal mortality ratio for the nation has not decreased since 1982 (1). Approximately 50% of pregnancy-related deaths remain preventable (2), and the extent of morbidity associated with pregnancy is often unrec- ognized. Safe motherhood begins before pregnancy with healthy lifestyles that include good nutrition, physical activity, preconception care, and avoidance of harmful sub- stances. Safe motherhood continues with planned pregnancies; early, quality prenatal care; knowledge of warning signs of problems; and the delivery of a healthy, full-term baby with the minimum of necessary interventions. Postpartum support for women and their families in a positive, nurturing environment also is important. In 1998, in the United States, women can plan, carry, and deliver a pregnancy more safely than in the past. However, additional efforts need to be taken to make safe motherhood a reality for all women. Improved public health surveillance, prevention research. and prevention programs are needed to continue improving the health of women before, during, and after pregnancy and delivery. Examples include new sur- veillance methods to monitor and understand pregnancy complications; prevention research on the essential content of prenatal care; and prevention programs to ensure the adequate intake of folic acid by women of reproductive age to prevent neural tube defects (3). The World Health Day Advisory Committee of the American Association for World Health coordinates World Health Day activities in the United States. Additional infor- mation about special events and resource materials about World Health Day 1998 are available from the American Association for World Health, 1825 K Street, N.W., Suite 1208, Washington, DC 20006; e-mail: [email protected]; or from the World-Wide Web site: http://www.aawhworldhealth.org. ONE HUNDRED SIXTH CONGRESS TOM BLILEY VIRGINIA CHAIRMAN W.J. "BILLY" TAUZIN. LOUISIANA JOHN 0 DINGELL MICHIGAN MICHAEL G. OXLEY OHIO HENPY A WAXMAN CALIFORNIA MICHAEL BILIRAKIS FLORIDA EDWARD MARKEY MASSACHUSETTS U.S. Douse of Representatives JOE BARTON TEXAS RALPHA HALL TEXAS FRED UPTON. MICHIGAN RICK BOUCHER VIRGINIA CLIFF STEARNS FLORIDA EDOLPHUS TOWNS. NEW YORK Committee on Commerce PAUL E. GILLMOR. OHIO FRANK PALLONE. JP. NEW JERSE. JAMES C GREENWOOD PENNSYLVANIA SHERROD BROWN. OHIO CHRISTOPHER COX CALIFORNIA BART GORDON TENNESSEE Room 2125, Rapburn Douse Office Building NATHAN DEAL GEORGIA PETER DEUTSCH FLORIDA STEVE LARGENT. OKL AHOMA BOBBY RUSH ILLINOIS Washington, DC 20515-6115 RICHARD BURR NORTH CAROLINA ANNA J ESHOO CALIFORNIA BRIAN BILBRAY CALIFORNIA RONKLINK PENNSYLVANIA ED WHITFIELD. KENTUCK. BART STUPAR MICHIGAN GREG GANSKE OW- ELIOT : ENGEL NEW YORK CHARLIE NORWOOD GEORGIA THOMAS SAWYER OHIO TOM COBURN OKLAHOMA ALBERT WYNN MARYLAND PIC-. LAZIO. NEW YORK GENE GREEN TEXAS BARBARA CUBIN WYOMING CARTHY MISSOURI JAMES ROGAN CALIFORNIA DISTRICKLAND OHIO COHN SHIMKUS LUNCE DIANA DIGETTE COLORADO HEATHER WILSON NEVIMENT THOMASM BARRETT WISCONSIN IOHNE SHADEGO ARIZONA MINNESOTA CHARLES V imp LOSCAPPE CALIFORNIA FOSSELLA NEW BLUN MISSO EDERYAN ROBERT SUBCOMMITTEE ON HEALTH AND ENVIRONMENT DATE: Wednesday, July 21, 1999 TIME AND PLACE: 10:00 a.m. in Room 2322 Rayburn House Office Building SUBJECT: Subcommittee on Health and Environment hearing on H.R. 1070. a bill to amend Title XIX of the Social Security Act to provide medical assistance for certain women screened and found to have breast or cervical cancer under a Federally funded screening program. WITNESS LIST PANEL I Dr. Nancy C. Lee Director Division of Cancer Prevention and Control Centers for Disease Control 4770 Buford Hwy. NE. MS-K64 Atlanta, GA 30341-3717 PANEL II Ms. Fran Visco Ms. Susan Braun President President and CEO National Breast Cancer Coalition The Susan G. Komen Breast Cancer 1707 L Street NW Foundation Suite 1060 5005 LBJ Freeway, Suite 370 Washington. DC 20036 Dallas, TX 75244 PANEL II continued Ms. Carolyn Tapp Dr. Stanley Klausner President 56 Amy Drive Women of Color Breast Cancer Survivors Sayville, NY 11782 Support Project 8610 Sepulveda Boulevard Los Angeles, CA 90045 HUMAN SURVICES DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Centers for Disease Control and Prevention (CDC) Atlanta GA 30333 TESTIMONY OF NANCY C. LEE, M.D. DIRECTOR DIVISION OF CANCER PREVENTION AND CONTROL NATIONAL CENTER FOR CHRONIC DISEASE PREVENTION AND HEALTH PROMOTION CENTERS FOR DISEASE CONTROL AND PREVENTION DEPARTMENT OF HEALTH AND HUMAN SERVICES before the SUBCOMMITTEE ON HEALTH AND ENVIRONMENT COMMITTEE ON COMMERCE U.S. HOUSE OF REPRESENTATIVES July 21, 1999 Good Morning. I am Dr. Nancy Lee, Director of the Division of Cancer Prevention and Control of the National Centers for Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC). I am pleased to be here this morning to discuss CDC's National Breast and Cervical Cancer Early Detection Program. Recognizing the value of appropriate cancer screening, Congress passed the Breast and Cervical Cancer Mortality Prevention Act of 1990 (Public Law 101-354). CDC is in the ninth year of the National Breast and Cervical Cancer Early Detection Program, which brings critical breast and cervical cancer screening services to underserved women, including older women, women with low incomes, and women of racial and ethnic minorities. While successes and advances have been made with the help of this program, challenges still exist. CDC supports early detection programs in all 50 states, five U.S. territories, the District of Columbia, and 15 American Indian and Alaska Native organizations. The program establishes, expands, and improves community-based screening services for women to reduce breast and cervical cancer mortality. The success of the breast and cervical cancer program depends on screening, education and outreach, partnership development, case management, and mechanisms to assure the quality of tests and procedures. Through September of 1998, more than 2 million screening tests have been provided to over 1.3 million women. That number includes 1 million Pap tests and 950,000 mammograms. Almost half of these screenings were to minority women, who have traditionally had less access to these 2 services. Over 5,000 women have been diagnosed with breast cancer, more than 30,000 women were diagnosed with precancerous cervical lesions, and 411 women had invasive cervical cancer. CDC collects data from all funded programs to monitor and evaluate each program's provision of clinical services. For each woman enrolled in the program, information is collected on demographic characteristics, results from mammograms, breast exams, and Pap tests, diagnostic procedures and outcomes, cancer diagnoses, and for women diagnosed with cancer, whether treatment was initiated. The program's success is due in part, from a large network of professionals, coalitions and national organizations dedicated to the early detection of breast and cervical cancer. An estimated 27,000 health professionals are involved in providing breast and cervical cancer screening services to underserved women. More than 18,000 health educators and outreach workers are educating women on the importance of early detection and helping them access critical screening and follow-up services. More than 7,000 individuals are now members of a national network of coalitions that have joined together with State health departments in support of this program. One of CDC's partners in the program, Avon, has raised more than $32 million in additional dollars to educate women about breast cancer and to provide underserved women with access to early detection services. 3 There has been a 20 percent increase in screening mammography rates among all women 50 years and older since 1991, when the program was formally established. For both mammograms and Pap tests, the disparity rates for most of the minority groups have either been eliminated or reduced. There has been a recent decline in the rate of breast cancer mortality. And while there remains much to be done, our most recent mortality data from 1996 indicates that we have met the Healthy People 2000 goal of reduced mortality from breast cancer. Insuring that all women with abnormal screening results receive adequate follow-up and a definitive diagnosis is a crucial component of this program. Thus, breast diagnostic services funded by federal dollars include diagnostic mammography, breast ultrasound, fine needle aspiration and breast biopsy and for the cervix, colposcopy and colposcopy-directed biopsy. The legislation that authorizes the National Program does not allow federal resources appropriated for the program to be used for treatment. However, States are required, under terms of the grants they receive, to assure that women who are screened and need cancer treatment, receive care. Data through March 1998 show that 92 percent of the women diagnosed with breast cancer and invasive cervical cancer have initiated treatment. The rest refused treatment, have not yet initiated treatment, or are lost to follow-up. For women diagnosed with breast cancer, data show a median*of 8 days between the cancer diagnosis and the initiation of treatment. 4 A detailed study of seven state screening programs conducted by Battelle Centers for Public Health Research and Evaluation and the University of Michigan, funded by the CDC, documents the innovative approaches that have been implemented to identify and secure resources for treatment services. The study confirmed what we see in our Program data that arrangements for treatment were made for almost all clients who received a diagnosis of breast or cervical cancer. States' efforts to secure treatment for women screened through the Program have been further documented in a separate study conducted by the Susan G. Komen Breast Cancer Foundation. State programs and their partners have invested significant amounts of time and effort to develop systems of care for diagnostic follow-up and treatment; these systems appear to be working. However, tremendous effort is involved in developing, implementing, and maintaining strategies and systems for these services. Rarely is there a standardized way that a State, tribe or territory obtains treatment services women need that are not covered by the program. Efforts typically are tailored to an individual client's needs and resources. State programs have developed sophisticated, creative and successful strategies to deal with the tremendous challenge of payment for cancer treatment. The following are some of the strategies that are employed by States to secure treatment services for women: Providers assist eligible clients in applying for Medicaid, Hill Burton funds, or other types of public assistance. Clients may be referred to public hospitals, or receive care though hospital community benefit programs, donated services, or other charitable care. 5 Contracts with screening providers require that agreements with treatment providers be established before screening commences. The Program appeals to treatment providers, through state and county medical societies and professional associations, to offer free or reduced-cost services to program clients. Case management was identified in the Battelle study as one strategy that could assist programs in their efforts to ensure the follow-up and treatment of clients. CDC has developed a comprehensive policy on case management for the program. Increases in CDC's FY 1999 appropriation will be used to expand critical case management services in States that strengthen the fragile system for securing treatment services. With these funds, each program will enhance case management activities to assist clients navigate through the system to obtain treatment services that are not covered by the program. Both North Carolina and Arkansas have appropriated State resources to the Cancer Control Programs to provide for cancer diagnostic and treatment services for all state citizens who meet eligibility criteria. California utilized a one-time allocation of $12.8 million from the Blue Cross Foundation to create a Breast Cancer Treatment Fund, which paid for treatment during the first year after diagnosis for any uninsured California women who met eligibility requirements. Unfortunately, this fund is nearly depleted. Although States are currently meeting their commitment to help women access treatment services, several of the programs reviewed in the Battelle study expressed concerns regarding their ability to expand screening services to more women in need because the systems in place 6 for obtaining charitable treatment are becoming overburdened. These programs stated that as long as the numbers of cancers diagnosed through the program remain near the current level, the burden should not be too great or too threatening. However, increased screening -- which is our goal -- is accompanied by increased numbers of cancers diagnosed, and many physicians who contract with programs are concerned about bringing more uninsured patients into their care, because of the need to provide treatment. Lack of sources for treatment can lead to screening problems in states where screening providers must have standing treatment referral options in order to screen. States are finding it more and more challenging to ensure that these women get the treatment they need. The labor-intensive and piecemeal approach needed to secure treatment services diverts human and financial resources away from the screening services. The overall goal of this program is to reduce mortality from breast and cervical cancers, and the success of this effort hinges on the identification and treatment of early stage cancers and precancers. As they have in the past, CDC and its state partners will continue to give priority to this critical aspect of the early detection effort. Let me relay to you how one woman felt about the program: I was forty years of age, a recently divorced women with no health insurance and working for peanuts when I discovered a lump in my breast. It was a very traumatic experience, to say the least. My fears that accompanied this finding were overwhelming. In my present financial position, I would have never received the medical attention I needed, if it wasn 't for your program. I am healthy, the lump was benign. Through this entire ordeal, I was able to focus all my energies on my medical problem, while your office proficiently attended the bills. 7 CDC's National Breast and Cervical Cancer Early Detection Program does not change whether or not a women has cancer. However, it can help women by improving their chances of detecting cancer earlier and getting treatment for it. And by finding and treating precancerous cervical lesions, the Program prevents thousands of women from ever developing cervical cancer. Thank you, and I would be happy to answer any questions you may have. NATIONAL BREAST CANCER COALITION it grassroots advocacy effort Testimony of Fran Visco, President National Breast Cancer Coalition before the House Commerce Committee Subcommittee on Health and Environment July 21, 1999 Thank you Mr. Chairman, and members of the Committee for inviting me to testify today. I am Fran Visco, President of the National Breast Cancer Coalition, and a breast cancer survivor. I am one of the 2.6 million women living with breast cancer in the U.S. today. The National Breast Cancer Coalition (NBCC) is a grassroots advocacy organization dedicated to eradicating breast cancer. We are made up of 500 member organizations and more than 60,000 individual women, their families and friends. NBCC seeks to increase the influence of breast cancer survivors and other activists over public policy in cancer research, clinical trials, and access to quality health care for all women. Background The National Breast Cancer Coalition has made passage of H.R. 1070, the Breast and Cervical Cancer Treatment Act, a top priority. As you know, this legislation would establish a federal treatment component for the Centers for Disease Control and Prevention's (CDC) National Breast and Cervical Cancer Early Detection Program (NBCCEDP) that Congress enacted as part of the Breast and Cervical Cancer Mortality Prevention Act in 1990. That program - - which has screened more than one-half a million women for breast cancer - does not provide any federal resources to pay for the treatment when women are diagnosed with breast or cervical cancer. Instead, Congress asks participating states to assure that the women who are screened get the treatment they need. The fact that the CDC Early Detection Program does not cover any costs of treatment for breast and cervical cancer has created a very serious public policy gap. State and local providers and women themselves have been left to scramble for resources to pay for treatment. Women are relying on charity and donated care when it is available and sometimes going into debt when no public or private dollars can be found. The NBCCEDP is a program dedicated to serving low-income women, but at times fails to come through. 1707 L Street. NW. Suite 1060. Washington, DC 20036 phone: (202) tax: 265-6851 tp:./www.natibcc.org Let me be perfectly clear. The individuals who run this program and the thousands of volunteers who help find women treatment do all that they can everyday to ensure that patients diagnosed through the program get the treatment they need. It is the people who do the screening and spend countless hours trying to find treatment who have identified the problems with a system that lacks a treatment component. It is the system that is broken, and we need to fix this problem so that they can screen more women, and not have to spend the majority of their time finding treatment services. What H.R. 1070 Would Do NBCC-Personal Stories Not long after the CDC screening program was enacted into law, Jan Eick-Swigart, an NBCC advocate from California, launched an effort to guarantee treatment for women screened and diagnosed with breast cancer through the federal program. Prior to losing her battle with breast cancer, Jan wrote a compelling memorandum on the need for a federal treatment component to CDC's Early Detection Program. Her memorandum states: "One of the heartbreaking ironies about the BCCEDP and other programs that offer underserved women free or low cost mammography is the lack of resources to treat the women who are diagnosed with breast cancer as a result of these programs." In the years following Jan Eick-Swigart's efforts to ensure that women screened and diagnosed with breast cancer through CDC's federal program are guaranteed treatment through Medicaid coverage, many NBCC advocates have reaffirmed the need for a federal treatment component to this program. Our members have witnessed the delay that can result from having to scramble to find treatment - and the physical and emotional result that delay has on women screened and diagnosed through the program. A woman in Florida had to wait 5 months before a volunteer found her treatment dollars. This woman had five agonizing months of knowing she was sick and having no way to get the treatment she so desperately needed. Moreover, we have heard from women who ultimately got treatment, but were then saddled with medical bills that they couldn't pay. Instead of focusing on getting well, these uninsured women have had to focus on how they are going pay for their care. A woman in Massachusetts, for instance, has already spent her children's college fund for her treatment and is paying off more than $20,000 in medical bills. Her story is incorporated in a statement from Mary Ann Waygan, coordinator for the CDC Breast and Cervical Cancer Initiative for Cape Cod, Massachusetts. (Mr. Speaker, may I introduce this statement into the record?) A woman in New York said that during her treatment, it seemed that her conversations with her doctors were more about the bills than how to save her life. There are other women who after having a mammogram find out they need follow-up diagnostic services but refuse to get them. They do not want to know they have cancer without knowing exactly where the treatment dollars come from. A woman from Virginia explained she "feels that if she is not diagnosed it is better because she will not have to worry about treatment." A woman from Maine had an initial mammogram through the NBCCEDP program and the results were "highly suggestive of malignancy." Due to the cost, rather than pursue a biopsy and the treatment, which may have been needed, the client decided to wait and have a repeat mammogram in six months. Surely, these scenarios are not what Congress intended when it enacted the National Breast and Cervical Cancer Early Detection Program into law. Yet, these scenarios are the reality of what happens when women are screened and diagnosed with breast and cervical cancer through a federal program that does not guarantee federal treatment coverage. CDC-Case Study NBCC is not alone in our belief that the CDC Early Detection Program needs a system that provides sufficient funding for treating women. In response to concerns about treatment raised across the country (and raised by advocates like us), CDC conducted a case study which illustrated a similar conclusion. The study focused on participating states (California, Michigan, Minnesota, New Mexico, New York, North Carolina and Texas) and looked at the treatment following a diagnosis of breast or cervical cancer through the program. The results of that study, released in January 1998, found that although treatment had been initiated for most of the women in whom cancer was diagnosed, the system of treatment is "tenuous and fragile at best." (Mr. Chairman, may I introduce the report which summarizes the results of the study into the record?) The Numbers Don't Tell Us the Whole Story I want to make very clear that the issue is not just that some women don't get treated. We have had to look beyond the numbers to find the real story. It is behind these numbers that the story exists - the story that women from all over the country come and talk to me about. It's the story that CDC's own study underscores. The story of women - diagnosed with breast and cervical cancer - wondering how and whether and when they'll find treatment for their disease, and then often left with a lifetime of bills to pay for that treatment. Lack of Treatment Funding Is Diverting Resources Away From the Screening Program There are several findings that are very telling in the conclusions of CDC's study. First, the study highlights the considerable time and effort involved in developing and maintaining systems for diagnostic follow-up and treatment. It illustrates the labor- intensive process required to identify resources within states to provide diagnostic and treatment services. NBCC has heard about the serious problems people who run the screening programs across the country have in finding treatment for women diagnosed through the program. The hours spent searching for treatment are diverting resources away from the screening program. As a result, fewer women are being screened. This is very serious - the program currently serves only 12% to 15% of age eligible, uninsured women nationally. The threat that the lack of treatment funding poses - not only to the woman who have been diagnosed through the program - but also to the women who may rely on the screening services in the future - is lethal. This is the story behind the numbers. It is our hope that in enacting a Medicaid option for these women, they will be presumed eligible for Medicaid on the first day that they are diagnosed. This way - they know they'll get the immediate care they need instead of facing delays and wondering how and whether they'll get treated. This way - program coordinators can focus their efforts on increasing the number of women they are able to screen for breast and cervical cancer. In the Context of an Evolving Health Care System Second, the CDC study puts this issue in the context of an evolving health care system. The study highlights what we too are hearing from our advocates around the country, and what Dr. Stanley Klausner has testified about today - an increasing number of physicians who do not have the autonomy, because of the changes in the health care system, to offer free or reduced-fee services to NBCCEDP clients. Mr. Chairman, I point you to a letter from Robert Brooks, MD, Secretary of the Department of Health for the Florida Department of Health and Human Services. (Mr. Chairman, may I submit this letter for the record?) In his letter, Dr. Brooks writes, "We are starting to see the strain our providers are experiencing through their support of the program One county program had had three women diagnosed with breast cancer during their first two years in operation; each one cared for by a different provider. Since October, 1998, five additional women have been diagnosed and approximately 10 to 15 more have abnormal clinical breast exam or mammogram results and could be diagnosed with cancer. Needless to say, the providers are concerned with these increasing numbers. Some of the providers have asked the local program coordinator not to refer additional patients to them for the remainder of this " program year Another county program has seen a total of 10 women with cancer and they have two to three physician providers and one hospital provider who agrees to see program clients. Three providers have also expressed alarm at the number of women with abnormal exams who are referred to them for care. We have been told that these current providers may not be willing to support the Program when this county renews their program agreement this October And the stories go on. Dr. Brooks concludes with the fear that Florida's providers continue to show signs of abandoning this program unless they are provided with some assistance that is not available through the CDC grant. Florida, a state with the highest degree of managed care penetration in the country, is perhaps one of the best (but certainly not the only) example of a situation where the lack of availability of treatment can only get worse, and where any attempts to expand the screening program are hindered. It is important to note that as managed care continues to expand across the country, more and more doctors may have less autonomy to provide the charity care relied on by NBCCEDP coordinators. To illustrate this point, a recent survey based on 12,000 U.S. physicians was published in the April 1999 issue of the Journal of the American Medical Association. The study finds that doctors whose income depends most heavily on health maintenance organizations and other managed-care health plans, on average, devote only half as much time to charity care as do their colleagues who don't participate in managed care. What will this mean for the people who run the NBCCEDP programs who are already spending countless hours searching for treatment for women diagnosed with breast and cervical cancer? What will this mean for women who are already suffering a delay in treatment? Or who are saddled with treatment bills they can't pay? Or who are reluctant to get screened because they "prefer not to know" if there is no treatment available? What will this mean for the ability of the National Breast and Cervical Cancer Early Detection Program to sustain itself? Precedent in the Medicaid Program Respondents in CDC's study suggest a similar solution to the lack of funding for treatment that we bring before you today - a solution that passage of H.R. 1070 would guarantee. That solution is a provision of treatment services assured through a federal "Medicaid option" which would give state Medicaid programs permission to allow eligibility to BCCEDP clients who are diagnosed with cancer through the program. This would include those women who are eligible for BCCEDP services but whose incomes and/or assets exceed Medicaid limits. There is a precedent for covering participants in the Breast and Cervical Cancer Early Detection Program under Medicaid. In 1993, Congress created the Tuberculosis Optional Benefit Program, making individuals who are infected with tuberculosis eligible for Medicaid. Mr. Chairman, and Members of the Committee, as the stories of NBCC's advocates and as the results of CDC's own study show - what we have today is an ad-hoc system that is incapable of serving the future needs of the program and the women it serves. Solutions in the vast majority of states are short-term, tenuous and fragile. The fact that so many women eventually get treated reflects the dedication of providers and volunteers who spend enormous effort and time to find treatment services. Yet, while the majority of women get care, there is no system of care. As a result, some women experience unnecessary delays or are lost to follow-up care, and a few don't get treated at all. Our message is not to put an end to the screening program. It is to finish the work Congress initiated in 1990 by adopting a treatment component that will serve all the women screened and diagnosed with breast and cervical cancer through this program. How This New Treatment Program Would Work Enactment of H.R. 1070 would allow the women who are eligible for the CDC Early Detection program -- that is women who are between 200% and 250% of poverty depending on their state and who are not already insured -- to receive their treatment through the state Medicaid program. States would not be required to participate, but those that do will receive an enhanced match - 75 percent federal dollars and 25 percent state dollars. NBCC is heartened by the incredible support for this legislation from you, Mr. Chairman, and from the Committee. All but three Subcommittee members have signed on as cosponsors, and three quarters of the Full Commerce Committee has cosponsored H.R. 1070. We are pleased that in a bipartisan way - this Committee has come together in recognition that breast and cervical cancer screening alone does not prevent cancer deaths; it must be coupled with treatment if we are to achieve a reduction in mortality. We now ask the Committee to ensure that happens as the screening program grows by enacting H.R. 1070, the Breast and Cervical Cancer Treatment Act this Congress. Mr. Chairman, and members of the Committee, thank you again for the opportunity to testify. We look forward to working with you on this critically important issue. I'd be happy to answer any questions you may have. Acknowiedgments Follow-Up and Treatment Issues in Funding for this study was from the Canters for Disease Control and Prevention, Division of the National Breast and Carvical Cancer Prevention and Control Cancer Early Detection Program The study was designed and implemented by a team of investigators from Battelle Centers for Public Health Research and Evaluation and the Study Results University of Michigan School of Public Health January, 1998 Research Team Goals of the Study Batteile Centers for Public Health Research University of Michigan To document strategies and methods used by and Evaluation: School of Public Health: states to obtain follow-up diagnostic services not covered by NBCCEDP funds. Lowell Sever. Ph.D. Paula Lantz. Ph.D. To document strategies and methods used by Martha Hare. Ph.D. Lisa Richardson, M.D., M.P.H. states to obtain treatment services for clients Cartyn Orians, M.A. Deb Macklem. M.Ed. diagnosed with CIN or cancer. Jane Schulman, Ph.D. To identify strategies that are perceived as successful or innovative in securing diagnostic and treatment resources. Flow of Follow-Up and Treatment Activities Research Questions Focus of Case Study What guidelines. policies or methods have been developed and implemented by states to ensure State finan and Cornect Count Screaming Diagnosis Transment that women with abnormal screening results and Early Detemes Programs women diagnosed with cancer or precancerous lesions receive diagnostic follow-up and treatment services? How is the component of the program that identifies and secures diagnostic and treatment Sampre . - Sumple - help - - - - due - services organized? - - 1) - - - I What role do coalitions or other partnerships play? they - n - Research Questions Phases of the Study Have the methods or tactics being used to identify Phase : Core set of data on 35 programs and secure diagnostic and treatment resources changed with time. and do they differ within the Phase IL in-depth case study of 7 states individual state programs or across programs? What are the key lessons learned regarding Phase III: Linkage study (in process)-Tumar diagnostic and treatment services in a program such as the NBCCEDP? registry data and program data from 3 states (CA, MI, NM) were linked to document timing of treatment initiation and initial course of cancer treatment What is a Case Study? Conducting a Case Study A case study seeks to understand the way in which a Describe Sales - program. system, or organization works within its Crime for Properms leaketing Evens for everyday setting Case - ! I the Store Collection It facuses on a particular problem. issue. or structure Quannisms a Madel which is studied in relationship to the larger program, be or I Daman Date Anyword Company Collernas system. or organization Through 1 Insurance - Collection While describing this relationship, the case study may or may not lead to conclusions about outcomes Platinum I Devement Date A case study uses all appropriate sources of Date Care Soudy American Plan Analysis - evidence - written, observational, and interview - that may be analyzed both qualitatively and quantitatively Case Study Selection Criteria Case Study States Provided screening for at least three years State Number of Breast Region Cancers Diagnosed Diagnosed 60 or more breast cancers since California 168 West screening began Michigan 249 Midwest Representative of the following stratification Minnesota 137 Midwest criteria: New Mexico 169 West Centrailzed versus decentralized programs Geographic region of United States New York 173 Northeast Urban/rural mix of the population North Carolina 106 South Racial and ethnic diversity among program clients Texas 307 South How Did We Conduct the How Did We Conduct the Case Study? Case Study? Contacted the coordinator for each of the seven Interviewed State BCCEDP Coordinator and programs to schedule site visits. and to obtain other staff who work with diagnosis and background information treatment issues Reviewed documents supplied to us by the state Interviewed local coordinators and providers program. such as organizational tables. reports in a variety of settings throughout the state and articles Interviews were tape recorded. transcribed, Traveled to each state and briefed state BCCEDP and entered into a word processing database staff regarding the project at the beginning of each state's site visit How Did We Analyze the Data and Write How Did We Analyze the Data and Write the Case Study State Summaries? the Case Study State Summaries? The Project PI and the Case Study Coordinator Using the analyzed transcripts, a member of the developed a codebook based on the research site visit team developed a state summary questions in the Case Study Protocol Each member of the site visit team reviewed the Using the codebook, the PI and Coordinator state summary worked together to achieve 80% inter-rater The summary was then sent to state program agreement on the use of codes for text. and then staff and other interviewees for review trained one other team member Reviewer feedback was incorporated into a All interviews were coded and entered into a text revised state summary analysis software Number of Interviews Case Study Results by State and Role Site visits were conducted February-June, 1997 TOTAL CA MI MN NM NY NC TX A total of 126 interviews were conducted State staff sa 13 4 11 4 , 10 7 A total of 192 people were interviewed Local statf 15 : : : 4 4 I Screening 60 3 $ 1 5 7 U 1 provider Dx or Tx previder 45 7 4 9 1 1 13 , 6 Advisory Board 10 : I 3 I : I Condition member Other 4 1 #4 - TOTAL 192 :7 16 12 :1 :4 49 a Strategies Used to Ensure Provision of Strategies Used to Ensure Provision of Diagnostic and Treatment Services Diagnostic and Treatment Services Common Approaches at the Local Level: Common Approaches at the State Level: Bill insurance Assist clients in applying for Medicaid, Hill Burton Clients followed through use of tracking and funds, other assistance programs follow-up systems Referral to public hospital Requirements in contracts with providers Charity care, donated services Appeals to providers through state medical Case rotation societies, professional associations, etc. Reduced fees Negotiated payment plans Clients pay fee for service Additional Strategies Used by States General Findings Across States Blue Cross Foundation treatment fund CA* States have found supplemental funds (primarily for breast cancer diagnostic services) Race for the Cure fund MN* Women diagnosed with cancer who want to be State breast cancer programs NY* treated are receiving treatment Other state funds TX". NC Strong reliance on providers to find resources Tobacco excise tax fund CA", MI Follow-up handled on case-by-case basis Providers of last resort NM, TX County indigent funds NM, TX funds used for breast services only General Findings Across States Strengths Solutions, strategies and networks are tenuous Women who need and want cancer treatment are and fragile receiving it Programs operate within changing health care Creative responses and strong partnerships have environments (i.e. growth of managed care) emerged at state, local and provider level Information lacking for many important issues: Availability of state or foundation funds to supplement Federal resources -payment source for diagnostic and treatment services -out-of-pocket expenses for women -impact of financial barriers on time delays/refusals Strengths Areas of Concern Centralized tracking systems work well Lack of financial support for diagnosis and treatment Program has had positive effect on tracking and Time and energy required for follow-up is tremendous follow-up in larger community Burden of follow-up has led to restrictions in number women screened Several barriers to provider recruitment: low reimbursement rates (mandated by Congress) -lack of coverage for all diagnostic follow-up services Fability for treatment administrative ourden of follow-up Areas of Concerns Areas of Concern Some women experience time delays or are lost to follow-up Categorical nature of program prohibits a more (especially in regard to cervical services) comprehensive approach to women's health A small number of women have refused cancer treatment Financial access is only one dimension of access to Coordinating diagnostic follow-up is greater burden than health care services. Many non-financial barriers arranging treatment impede follow-up care: Resources states have developed are short-term solutions, logistical barriers (as transportation, scrieduling) and difficult to manage/administer - cultural barriers (a.g. language barners. fatalistic attitudes, (ear) - immigration issues Respondent Recommendations Conclusions of Case Study Program should pay for all diagnostic and treatment Strong response to provision of diagnostic follow-up services, or at least through definitive diagnosis and treatment services has emerged Allow state resources used for all diagnosis and Wide range of strategies is employed within states; treatment services to be counted in the 3:1 match effort at local level is tremendous Cover anesthesia and other affiliated services Responses that have emerged are administratively Increase reimbursement rate for services covered cumbersome and unstable; long-term solutions are Increase support for case management and community needed infrastructure Strong commitment to continued growth and success Universal health insurance of the NBCCEDP exists at state and local level Linkage Study - Linkage Study - Research Questions Research Questions What proportion of women identified through What are the components (surgery, radiation, selected states' BCCEDPs as having breast chemotherapy. hormonal therapy) of the or cervical cancer did not receive an initial initial course of cancer treatment for women course of treatment, based on registry identified through the BCCEDPs as having records? breast or cervical cancer? What characteristics of women and their cancers What characteristics of women and of their are associated with not receiving treatment? cancers are associated with the content of the initial course of treatment? Linkage Study - Linkage Study - Research Questions Research Questions What is the time interval between abnormal How does the information from the program screening and diagnosis? database compare with the corresponding What is the time interval between diagnosis information from the cancer registry database? and treatment? How do women screened through the program What characteristics of women and their cancers compare with all women in the registry with appear to be related to these time intervals? regard to patterns of diagnosis and treatment? CDC March 27. 1998 / Vol. 47 / No. 11 209 imported Dracunculiasis - United States, 1995 and 1997 MMWR 211 Update: HIV Counseling and Testing Using Rapid Tests - United States. 1995 2151 Strategies for Providing Foilow-Up and Treatment Services in the National Breast and Cervical Cancer Early Detection Program - - United States. 1997 MORBIDITY AND MORTALITY WEEKLY REPORT 218 World Health Day - Apnil 7. 1998 219 Notices to Readers Imported Dracunculiasis - United States, 1995 and 1997 Dracunculiasis is a parasitic infection caused by a filarial worm (Dracunculus medi- nensis (i.e., Guinea wormi) that is transmitted through contaminated drinking water. Approximately 1 year after a person is infected. one or more meter-long aduit female warms begin to emerge through the skin, often incapacitating the patient for ≥2 months. Despite a dramatic decrease in cases worldwide, dracunculiasis is still occa- sionally imported into the United States. Since 1995, two cases of dracunculiasis have been reported in the United States. both imported from Sudan. This report summa- rizes the investigation of these cases. Patient 1. A 9-year-old girl residing in Tennessee had emigrated from Sudan in Sep- tember 1995 (7). Before the girl left Sudan, a Guinea worm had emerged and had been extracted from her right lower leg. The lesion had healed when she arrived in the United States. After she had been in the United States for 3 weeks, another Guinea worm began to emerge from her left leg. Medical examination at a local health clinic revealed a string-like worm dangling from a lesion on her left leg, and she was re- ferred to an infectious disease specialist. The leg was secondarily infected and swol- len, and the girl was unable to walk. Despite antibiotic treatment, her cellulitis did not improve, and the lesion was surgically opened. drained, and debrided of pus. necrotic debris, and fragments of the Guinea worm. The patient was hospitalized for 2 weeks, requiring surgery to stretch a contracture of her ankle and to apply a skin graft to the wound. After outpatient physical therapy, she was able to walk without crutches. Patient 2. A 31-year-old woman residing in Connecticut had emigrated from Sudan in January 1997. In April 1997, she was evaluated at a university clinic for possible tuberculosis (TB). A radiograph revealed lung lesions consistent with TB and a worm- like calcification in her left chest. Physical examination revealed multiple. indurated, oval lesions 4-3 cm in diameter on both lower legs. The patient reported the lesions had been present for 1 year and were intermittently painful. She recalled that a long string-like worm had emerged from her leg during the previous year. Biopsy of the leg lesions revealed erythema induratum, consistent with Bazin disease, a cutaneous manifestation of TB. The patient had evidence of a dead and calcified Guinea worm in her chest and a history suggesting a live Guinea worm had emerged from her leg before she arrived in the United States. She also had pulmonary TB with a cutaneous tuberculid skin manifestation. Treatment with isoniazid, rifampin, and pyrazinomide U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES Vol. 47 / No. 11 MMWR 215 HIV Counseling and Testing - Continued ing that persons who receive preliminary results understand the meaning of the result and prefer rapid testing (4). When additional rapid tests become available for use in the United States. the PHS will re-evaluate algorithms using specific combinations of two or more rapid tests for screening and confirming HIV infection. References 1. Kamb ML Bolan G. Zenilman J. et al. Does HIV/STD prevention counseling work? Results from a multi-center randomized trial (Project Respect) (Abstract 01341 In: Program and abstracts of the International Congress of Sexually Transmitted Diseases. Seville, Spain: Association for Research in Clinical Microbiology, 1997:83. 2 CDC. HIV counseling and testing in publicly funded sites: 1995 summary report. Atlanta: US Department of Health and Human Services, CDC. September 1997. 3. George JR, Schochetman G. Detection of HIV infection using serologic techniques in AIDS testing: a comprehensive guide to technical, medical, social, legal. and management issues. 2nd ed. Schochetman G, George JR. eds. New York: Springer-Veriag, 1994. 4. Kassler WJ. Dillon BA, Haley C. Jones WK, Goldman A. On-site. rapid HIV testing with same-day results and counseling. AIDS 1997;11:1045-51. 5. CDC. Interpretation and use of the Western blot assay for serodiagnosis of human immunode- ficiency virus type 1 infections. MMWR 1989:38(suppi 7):S4-S6. 6. Stetler HC, Granade TC. Nunez CA. et al. Field evaluation of rapid HIV serologic tests for screen- ing and confirming HIV-1 infection in Honduras. AIDS 1997;11:369-75. 7. Kassler WJ, Haley C. Jones WK, Gerber AR, Kennedy EJ. George JR. Performance of a rapid, on-site human immunodeficiency virus antibody assay in a public health setting. J Clin Mi- crobiol 1995;33:2899-902 Strategies for Providing Follow-Up and Treatment Services in the National Breast and Cervical Cancer Early Detection Program — United States, 1997 The Breast and Cervical Cancer Mortality Prevention Act of 1990* authorized CDC to establish the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) to increase screening services for women at low income levels who are uninsured or underinsured (1). Although the NBCCEDP covers most diagnostic serv- ices that women need after receiving an abnormal mammography or Papanicolaou (Pap) test result, the program does not reimburse for breast biopsies. In addition, the Act prohibits the use of NBCCEDP funds for cancer treatment. Participating health agencies must ensure that NBCCEDP clients receive timely, appropriate diagnostic and treatment services. in 1996, CDC began a case study to determine how early de- tection programs in seven participating states (California, Michigan, Minnesota, New Mexico, New York, North Carolina, and Texas) identified resources and obtained diag- nostic and treatment services. This report summarizes the results of the study (2). which indicate that respondents in these states reported that treatment had been initi- ated for almost all NBCCEDP clients in whom cancer was diagnosed. However, re- spondents also considered the strategies used to obtain these services as short-term solutions that were labor-intensive and diverted resources away from screening ac- tivities. in the seven states, NBCCEDP-sponsored screening services had been provided for ≥3 years, and breast cancer had been diagnosed in >60 women. The states were se- *Public Law 101-354. 216 MMWR March 27. 1998 National Breast and Carvical Cancer Early Cetection Program - Continued lected to provide a range of geographic locations, a combination of urban and rural populations, and racial/ethnic diversity among program clients. Researchers con- ducted semi-structured interviews with 192 persons affiliated with the seven state programs. Of these interviewees. 120 (63%) were providers of screening, diagnostic, and/or treatment services: 58 (30%) were state program staff: and 14 (7%) were coali- tion members. Interviews included topics. such as guidelines related to diagnostic and treatment services, strategies used to obtain and pay for services, level of effort re- quired to secure these services. and changes in strategies over time. Each interview was tape recorded and transcribed. Using a systematic scheme derived from the re- search questions, three researchers coded the same transcripts until an inter-rater agreement of 80% was reached. Thereafter, all transcripts were coded independently. Coding results were entered into text analysis software that sorts text from transcripts into sets of information, themes, and evidence relevant to the specific research ques- tions (3). The resuits reflect a synthesis of the interviewees' responses. Respondents described several strategies used to ensure necessary diagnostic and treatment services for women screened through the NBCCEDP. State-level strategies in all states included 1) computerized tracking and follow-up systems that used pro- gram surveillance data to identify and manage clients in need of diagnostic and treat- ment services: 2) provisions in contracts requiring screening providers to arrange for diagnostic follow-up and treatment before screening women; and 3) arrangements with provider groups and state professional associations for free or reduced-cost serv- ices for NBCCEDP clients. All states also had access to public or private funds to help support services not covered by the program; such revenue sources included state appropriations from general or tobacco tax revenues or funds from private founda- tions. These funds were available primarily for breast diagnostic services. Local strategies tailored to the needs of individual clients were used to obtain diag- nostic and treatment services. Common strategies reported by respondents included the following: providers billed public or private insurance plans; providers or local health departments helped clients apply for public assistance programs; providers re- ferred clients to public hospitals; county indigent-care funds and hospital community- benefit programs financed services; clients received services through individually negotiated payment plans; and clients paid reduced or full fees for services. Respondents strongly supported the continued growth of NBCCEDP and its goals but expressed several concerns. First, considerable time and effort were involved in developing and maintaining systems for diagnostic follow-up and treatment. Second. the process of identifying available resources within states for diagnostic and treat- ment services was considered labor-intensive. Third. the lack of coverage for diagnos- tic and treatment services negatively affected recruitment of providers and restricted the number of women screened. Fourth. respondents believed that an increasing number of physicians will not have the autonomy, because of changes in the health- care system, to offer free or reduced-fee services to NBCCEDP clients. Respondents reported that arrangements for treatment were made for almost all NBCCEDP clients who received a diagnosis of breast cancer or invasive cervical can- cer. Respondents stated that some women experienced time delays between screen- ing, definitive diagnosis. and initiation of treatment. State program officials reported that. according to 1992-1996 surveillance data, small numbers of clients in whom can- cer was diagnosed (i.e., from three to 13 women in each state) subsequently refused Vol. 47 / No. 11 MMWR 217 National Breast and Carvical Cancer Early Detection Program - Continued treatment. Because these clients were not interviewed. it could not be determined whether financial barriers contributed to their decisions to refuse treatment or their loss to follow-up. Respondents were concerned that the NBCCEDP did not provide funding for all diagnostic procedures and treatment for the diseases for which clients were being screened; approaches for delivering services were fragmented; and the process of ob- taining resources required substantial effort at the state. local, and provider levels. Respondents reported that the continuation of every strategy for diagnostic and treat- ment services beyond the next few years is uncertain. Reported by: PM Lantz, PhD. Univ of Michigan School of Public Health, Ann Arbar. LE Sever. PhD. Battelle. Centers for Public Health Research and Evaluation. Seattle, Washington. Program Svcs Br. Office of the Director, Div of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion, CDC. Editorial Note: During July 1991-March 1997, the NBCCEDP provided 576.408 mam- mograms to women aged ≥40 years. and 3409 cases of breast cancer were diagnosed. During this same period. the program provided 732.754 P3p tests: 23.782 cases of cer- vical intraepithelial neoplasia and 303 cases of invasive cervical cancer were diag- nosed. These totals included women referred to the program for diagnostic evaluation of an abnormal screening result. The NBCCEDP internal estimates suggested that dur- ing this period only 12%-15% of uninsured women aged 40-54 years in the United States had been screened by the program (CDC. unpublished data. 1997). Screening alone does not prevent cancer deaths; it must be coupled with timely and appropriate diagnostic and treatment services. The Congressional mandate for NBCCEDP requires grantees to take all appropriate measures to ensure provision of services required by women who have abnormal screening results. CDC provides funds for case management to help these women access health-care services. To in- crease the comprehensive nature of the program, CDC recently approved the use of NBCCEDP funds for breast biopsies. The results of this study indicate that state health departments and their partners in the seven states had developed a wide range of strategies for diagnostic and treat- ment services in the absence of program resources. However, the time and effort re- quired to arrange and maintain these services diverted resources away from screening activities. This study was subject to at least two limitations. First, the results were based solely on the experience and opinions of informed professionais affiliated with the program and did not include the perspectives of NBCCEDP clients. Second. the results may not reflect the program experiences in other states. Case-study methods. how- ever, are an appropriate and well-accepted approach to gaining in-depth under- standing of complex programs in real-life situations (4). The validity of the findings was enhanced by developing standard instruments to guide the semi-structured inter- views, protecting the confidentiality of respondents' remarks, using interview tran- scripts for data analysis rather than relying on interviewer notes, and obtaining feedback concerning state summary reports from respondents. As more women are screened by the NBCCEDP, a greater burden will be placed on participating health agencies, providers. and other partners to obtain resources for breast and cervical cancer treatment. Case-management services will continue to be essential in helping underserved women overcome financial, logistical, and other bar- 218 MMWR March 27, 1998 National Breast and Cervical Cancer Early Detection Program - Continued riers to receiving these services. Other long-term solutions to ensure that women in the program receive necessary treatment services are being pursued. References 1. Henson RM, Wyatt SW. Lee NC. The National Breast and Cervical Cancer Early Detection Pro- gram: a comprehensive public health response to major health issues for women. J Public Health Management and Practice 1996:2:36-47. 2 Lantz PM. Macklem DJ. Hare M. Richardson LC. Sever LE. Orians CE. Follow-up and treatment issues in the National Breast and Cervical Cancer Early Detection Program: results from a multiple-site case study-final report. Baltimore: Batteile, Centers for Public Health Research and Evaluation, 1997. 3. Miles MB. Huberman MA. Qualitative data analysis: an expanded sourcebook. 2nd ed. Thou- sand Oaks. California: Sage, 1994. 4. Yin RK. Case study research: design and methods. Sage: Newoury Park, 1989. Notice to Readers World Health Day - April 7, 1998 "Invest in the Future: Support Safe Motherhood" is the theme in the United States for World Health Day, April 7. 1998. In the United States. this day will focus on the continued importance of maternal health and opportunities to improve this aspect of women's health. Although the risk for women dying from pregnancy has decreased substantially during the past 50 years. the maternal mortality ratio for the nation has not decreased since 1982 (1). Approximately 50% of pregnancy-related deaths remain preventable (2), and the extent of marbidity associated with pregnancy is often unrec- ognized. Safe motherhood begins before pregnancy with healthy lifestyles that include good nutrition, physical activity, preconception care, and avoidance of harmful sub- stances. Safe motherhood continues with planned pregnancies; early, quality prenatal care; knowledge of warning signs of problems; and the delivery of a healthy, full-term baby with the minimum of necessary interventions. Postpartum support for women and their families in a positive, nurturing environment also is important. In 1998. in the United States, women can plan, carry, and deliver a pregnancy more safely than in the past. However, additional efforts need to be taken to make safe motherhood a reality for all women. Improved public health surveillance, prevention research, and prevention programs are needed to continue improving the health of women before, during, and after pregnancy and delivery. Examples include new sur- veillance methods to monitor and understand pregnancy complications: prevention research on the essential content of prenatal care; and prevention programs to ensure the adequate intake of folic acid by women of reproductive age to prevent neural tube defects (3). The World Health Day Advisory Committee of the American Association for World Health coordinates World Health Day activities in the United States. Additional infor- mation about special events and resource materials about World Health Day 1998 are available from the American Association for World Health, 1825 K Street, N.W., Suite 1208. Washington, DC 20006; e-mail: [email protected]; or from the World-Wide Web site: http://www.aawhworldhealth.org. Statement of Mary Ann Waygan March 18, 1999 Hello. my name is Mary Ann Waygan and I am the coordinator for the CDC Breast and Cervical Cancer Initiative for Cape Cod, Massachusetts. Before I begin, I would like to thank Senators Chafee, Mikulski. Snowe and Moynihan for sponsoring this legislation. I would also like to thank Senator Smith for his support of this bill. Clearly, the single largest problem facing the Breast and Cervical Cancer Screening Program today is finding resources and caregivers to provide treatment to the women who are diagnosed with breast or cervical cancer. The lack of treatment dollars is one of the biggest policy gaps in the program - and the problem is only getting worse. The barriers to recruiting providers for charity care are growing, and funding for the treatment is an ad-hoc system that relies on volunteers, state workers and others to find treatment services. In the community, we go to tremendous ends to find treatment - and raise money to help pay for it. I've organized luncheons, bake sales, raffles - you name it. Anything to raise money for women who could not afford to pay out of pocket for treatment. Despite these efforts, all too often, we come up short. Funding for treatment through the CDC program is the biggest problem I face as a coordinator and frankly a barrier to screening and detection. Funding for treatment is tenuous at best. Without passage of the Breast and Cervical Cancer Treatment Act, future funding for treatment for these women will remain uncertain. I want to tell you one story in particular that clearly illustrates the problem some of these women face. A woman who lives in Buzzard's Bay, Massachusetts who was diagnosed with breast cancer through the CDC program. Arlene McMann is a married woman in her early forties with two teenage sons and no health insurance. When Arlene was diagnosed with breast cancer through the CDC screening program, she was devastated - not just with the diagnosis, but with the fact that she had no way to pay for the treatment she needed. Faced with that situation, she and her husband were forced to use the $20,000 they had been saving for years to pay for their children's college tuition. In less than a year, that money was gone. After that, she and her husband were forced to go into debt to pay for her ongoing chemotherapy/radiation treatment and other procedures including a craniotomy and gall bladder surgery. They are now more than $40,000 in debt, were forced to move into a much smaller house and lost their dream of sending their sons to college without going into further debt. The additional stress and pressure placed on Arlene and her husband by this situation has turned a difficult situation into an almost unbearable one. To make it even worse, Arlene recently found out that the cancer has spread to her hip, pelvis, lungs and liver. Through all of this. Arlene has showed tremendous resolve. Despite being in pain and discomfort and forced to use a wheelchair, Arlene desperately wanted to be here today to share her story with you directly. She thought it was important for everyone to understand not just what the cancer had done to her. but what the affect of having to take on this incredible financial burden had done to her physical health, mental strength and family resources. Due to her condition. Arlene's treatment finally is being paid because she qualified for disability. But to this day, Ariene is convinced that her cancer would not have spread had she been able to afford regular visits to an oncologist. Arlene's energy and determination to fight this disease and remain positive are amazing. I feel lucky to know her and to have worked with her. I only wish that as the program coordinator, I could have done more - that I could have assured her that any treatment she needed would be paid for and that she wouldn't have to spend time dealing with bank statements, mortgages or packing boxes on top of everything else. In summary, we hear over and over again that early detection saves lives. In actuality, early detection alone does nothing but find the disease; detection must be coupled with guaranteed, quality treatment to actually save lives. We must pass the Breast and Cervical Cancer Treatment Act to make sure that screening and treatment always go together. I would like to thank the National Breast Cancer Coalition for its leadership role in working to get this legislation passed and thank the members of Congress here today for sponsoring and supporting this legislation. Thank you. Received: 7/12/99 10:41AM; 301 657 9341 .> NBCC; Page 2 Jul 12 99 11:06a Robyn Lipner 301-657-9341 p.2 HEALTH leb Bush Robert G. Brooks. MD. Governor Secretary June 22 1992 The Honorable Connie Macx United States Senate 517 Hart Senate Office Building Washington DC 20510 Dear Senstor Mack This letter in response to the May 4th telephone inquiry from Mark Smith to Margo Blake regarding cancer treatment for women enrolled in Florida's Breast and Carvical Cancer Early Detection Program (the Program) Thank you for allowing us the opportunity to furnish some details about the Program. Florida received its award from the Centers for Disease Control and Prevention (CDC) in late sum mer 1994 We started operations in nine counties in September 1995 and graw to 20 nties in 1996. The 20 counties are comprised of large urban areas, mid-sized counties and small rural counties (A map depicting all 20 participating counties IS enclosed.) Population data show that there are approximately 275.000 women. ages 50-64 in Florida who are under or uninsured Slightly over 175.000 of these women reside in the 20 participating counties Since late 1995, CDC grant funds have allowed the Program to provide screening services to slightly over 10000 eligible women Annually, the participating counties screen approximately 3,500 women or about 2 percent of the eligible population. One hundred thirty women have been diagnosed with breast or invasive cervical cancer through this Program in Florida. As you know CDC funds cover reimbursement at the Medicare rate. for breast and cervical screening services such as Pap smears and mammograms. There are also limited funds for specified diaf nostic procedure such as colposcopies. biopsies, and breast ultrasounds. The CDC fungs can not be used for reimbursement for treatment or other associated costs. This IS the Program's most vulnerable area as we are now entering a competitive application process for additional CDC grant funds to begin year SIX in October 1999 We are starting to see the strain our providers are experiencing through their support of the program Before providing case scenanos that demonstrate this strain, i would like to expand on the definition of provider as used throughout this letter Normally. we refer 10 the general or oncologic surgeon as the principal provider or treatment Many others also donate services to the breast and cervical program. These include oncologists radiologists radiation oneologists. pathologists and nospitals. The scenarios mentioned include the following One county program worked with a client diagnosed with cervical cancer in November 1998 The woman saw a gynecological encologist in January 1999 and underwent a hysterectomy in March after filing for Medicaid Her family had to pay $6825 up front to cover hospital costs. which may be covered retroactively by Medicaid 1020 Capital Circle SE . Tallahassee FL 52399-1700 301 657 9341 > NBCC; Page 3 Received: 7/12/99 10:41AM; 301-657-9341 p.3 Jul 12 99 11:07a Robyn Lipner Senator Mack Page two June 22. 1999 One county program had three women diagnosed with breast cancer during their first two years in operation; each one cared for by a different provider. Since October 1998, five additional women have been diagnosed and approximately 10 to 15 more have abnormal clinical breast exam or mammogram results and could be disgnosed with cancer Needless 11) say. the providers are concerned with these Increasing numbers. Some of the providers nave asked the local program coordinator not 10 refer additional patients to them for the remainder of this program year. Another county program has seen a total of 10 women with cancer and they have two to three physician providers and one hospital provider who agrees to see program chents These providers have also expressed alarm at the number of women with abnormal exams who are referred to them for care. We have been told that these current providers may not be willing to support the Program when this county renews their program agreement this Cictober Tine fourth county program diagnosed 10 women with breast cancer during their first two years and since January 1999 diagnosed four more women with breast cancer. Ten providers who originally agreed to each see one to two clients per year have formeo three separated groups who have agreed to see one to two clients per group. for a total of three to 5 X clients per year This would not be sufficient coverage if the rate of diagnosing cancer continues. CDC has informally conveyed to us that they may award the Florida Program more funds for breast and cervical acreening services in our next five-year grant cycle that begins this October Whiler this IS positive news for the many thousands of women at need for these services, we also pelieve this will have a domino effect on the providers who provide in-kind treatment. With increased numbers of women screened comes an increase in the numbers of cancers diagnosed. placing an ever-increasing burden on our already overwhelmed providers of cancer treatment! Please note these same providers more than likely also donate in-kind services to other clients diagnosed with cancer or other chronic diseases So while our information shows that a provider may furnish pro bono treatment for two or three women with breast or carvical cancer per year. in all likelihood that same provider IS ssked to donate treatment services for other clients as well. We are deeply indebted to all of these individuals and institutions for their support of the Program and would like to see them receive some measure of acknowledgement for their efforts In summary the Florida Breast and Cervical Cancer Program has provided cancer services to over 10,000 women at or below the 200 percent poverty level. and found treatment services for over 130 women through the generosity of local providers in 20 counties As screening numbers increase. so will the number of women diagnosed with breast or cervical cancer C. KONEN The Susan G. Komen Breast Cancer Foundation FOUNDATION National Headquarters STATEMENT OF SUSAN BRAUN PRESIDENT & CHIEF EXECUTIVE OFFICER OF THE SUSAN G. KOMEN BREAST CANCER FOUNDATION BEFORE THE SUBCOMMITTEE ON HEALTH AND ENVIRONMENT COMMITTEE ON COMMERCE JULY 21, 1999 5005 LBJ Freeway Suite 370 Dallas. Texas 75244 972.855.1600 fax 972.855.1605 Helpline 1.800 I'M AWARE (1.800.462.9273) Ensuring Breast Cancer Treatment among Uninsured Women Statement before the House Commerce Committee: Subcommittee on Health and the Environment Hearing: July 21, 1999 Good morning Chairman Bilirakis and members of the Committee: It is an honor to be offered the opportunity to speak before you today about the pressing issue of treating uninsured women with breast cancer. My name is Susan Braun, and I am president and chief executive officer of the Susan G. Komen Breast Cancer Foundation. The Komen Foundation was established 17 years ago by Nancy Brinker, in honor of her sister, Suzy Komen, who died of breast cancer at the age of 36. Our mission is to eradicate breast cancer by advancing research, education, screening, and treatment. To date, we have raised and spent more than $200 million toward this end. Our network of 106 Affiliates in 43 states and the District of Columbia, and the 35,000 volunteers that support them are conducting 98 Komen Race for the Cure® events this year. Last year, through the Race series and other fund-raising vehicles, we raised nearly $80 million. It is not to pat ourselves on the back that I share with you these figures. Rather, it is to help illustrate to you the reach of the Komen Foundation and to demonstrate that "grass roots" is a way of being for us, not a mere cliché. Further, it is to establish the level of trust that we have earned with the public -- trust that allows them to put a large sum of money in our hands with the assurance that it will be spent wisely in pursuit of our mission to eradicate breast cancer. We cherish that trust and work tirelessly to remain worthy. Komen affiliates work at the local level to build the public awareness of breast cancer and to establish the best settings possible for education and early detection. At a national level, we continue to establish programs to support our affiliates in these endeavors. In addition, we are (according to the Institute of Medicine) the largest private funder of research dedicated exclusively to breast cancer. Last year we funded 79 basic, clinical, and translational research grants, with grantees selected through a novel and well-respected blinded peer-review program. In addition we funded population-specific studies and post-doctoral fellows from our national grants fund for a total of over $17 million. Our affiliates granted another $25 million to local programs. Again, I describe this program not as a means of touting the successes of the Komen Foundation. Rather, I wish to underscore also that we are quite experienced as funders of novel and strong programs. We investigate our areas of spending in significant depth, ensuring that we are serving the public trust that has been placed in us. It is with this backdrop that we began to study the issue of treatment for underserved women over a year ago. Statement of the Problem: An estimated 175,000 new cases of breast cancer will be diagnosed in 1999 and 43,300 women will die of the disease. Despite promising new prevention treatments, finding and treating cancers in their earliest stage remains our most effective way of reducing the morbidity and mortality associated with this disease. The good news is that an increasing number of women are receiving mammograms. In 1995, over 80 percent of women 40 years of age and over reported ever having had a mammogram and about 60 percent reported having had a mammogram and clinical breast exam within the past 2 years. The National Breast and Cervical Cancer Early Detection Program (NBCCEDP), operated by the Centers for Disease Control and Prevention (CDC), has played a critical role in this achievement, ensuring that low income, underinsured and uninsured women are not left out of the success story. The NBCCEDP has 2 provided almost three-quarters of a million mammograms to low-income, underinsured and uninsured women. However, while the past decade has been witness to significant increases in the utilization of early detection services for breast and cervical cancer, we are now challenged to ensure access to necessary diagnostic and treatment services for women whose mammogram or Pap test yields suspicious findings. In working to assess how to best go about ensuring accurate diagnosis and appropriate treatment of breast cancer, we have established the following basic premises: Women diagnosed with breast cancer must be treated if they so choose, irrespective of their ability to pay. The quality of treatment they receive should be the highest possible. The time between diagnosis and initiation of treatment must be as short as possible. Care should be coordinated, ensuring the best care by the correct specialist. Care must not be short-term only; follow-up for at least five years is required. Upon establishing these central tenets, we then explored the critical questions that needed to be answered in order to provide timely, coordinated, comprehensive, and high-quality treatment to uninsured women. This led to four key questions: 3 Question One: What is the magnitude of need? Our very general estimates indicated that the potential magnitude of need is significant. As you can see in the chart attached to the following page, there are an estimated 1,000 women screened through the BCCEDP program each year who may require treatment assistance. In addition, there are an estimated 20,000 women who are eligible for BCCEDP but are not presently being screened, who are likely to develop breast cancer, and have no access to this program and what it offers in terms of diagnostic services and case management for further care. 4 ESTIMATED ANNUAL NUMBER OF WOMEN IN THE US IN NEED OF FINANCIAL ASSISTANCE FOR THE TREATMENT OF BREAST CANCER # of women ages 35-64 in the U.S. within screening range, 51,000,000 ineligible (by age only) for Medicare X .16 Percent uninsured 8,160,000 # of uninsured women in the U.S., ages 35-64 X .0029 Annual diagnosis rate, ages 35-64 # of uninsured women, ages 35-64, potentially 23,664 diagnosed with breast cancer each year 23,664 # of uninsured women, ages 35-64, potentially diagnosed 23,664 with breast cancer each year X 15 Percent of women reached by Percent of women not X .85 the NBCCEDP reached by the NBCCEDP 3,550 Potential number screened Potential number not 20,114 and diagnosed annually by screened/diagnosed through NBCCEDP NBCCEDP X .05 Percent not initiating Percent not initiating X 1.00 treatment treatment 178 Number of women with no Number of women with no 20,114 treatment screening or treatment 3,372 Potential number screened Potential number not 20,114 and diagnosed annually by screened/diagnosed through NBCCEDP who will initiate NBCCEDP treatment X 25 Estimated percent enrolled in NBCCEDP paying out-of- pocket 843 Number of women screened and diagnosed through NBCCEDP who may need treatment assistance (excluding the 5% not initiating treatment) 1,021 Estimated number of Estimated number of 20,114 women needing treatment women needing financial assistance (women not assistance for breast currently getting treatment cancer treatment or those who are receiving treatment but may need additional financial assistance) [843 + 178] Notes: This model is based on simple estimates to begin the process of determining the magnitude of need and where the need exists. The model is for breast cancer only. The number of unemployed is likely an overstatement of the true NBCCEDP reach; thus total number of treatment may be a high estimate. 5 Question Two: In which populations does the need for treatment assistance lie? The need for treatment assistance for women diagnosed with breast cancer lies primarily among the uninsured, medically needy, and/or underserved. In addition, insured women who have lost their coverage or have reached a lifetime maximum, particularly those being treated for a recurrence of their breast cancer, can be in need. Women with healthcare coverage but with a policy that excludes some forms of treatment may also be at need. Question Three: What can be done to meet the needs for treatment for those screened and diagnosed through the BCCCEDP and those not reached at all through the program? Reaching women who have been screened and diagnosed through the BCCEDP with treatment assistance is more straightforward than reaching those who are not. Those who have been diagnosed within the program can be assisted by case managers, who will help find available services or a program that can provide special national, state, or local funds. Eight states have legislated breast cancer treatment funds, and local programs (such as "The Bridge" in Dallas) also exist. Pro-bono care is provided in many communities. In the case of failure of these funding options, federal assistance may be required. To reach those women who are eligible for but unscreened by the BCCEDP, more outreach must be undertaken to ensure detection of breast cancer as early as possible to improve the likelihood of a favorable outcome. At present, due to lack of interaction with the healthcare system, these women may not be diagnosed at all, or may appear in emergency rooms or public clinics with advanced disease. For this group to be assured that early screening and diagnosis will be achieved, CDC program funding will require regular increases. 6 Question 4: What are potential models for meeting the needs of those diagnosed? Recognizing the growing need for additional information about the provision of breast cancer diagnostic and treatment services among women who have no means of support for such services, and in order to guide our actions as a funder of treatment assistance programs, the Susan G. Komen Breast Cancer Foundation initiated a study. It covered current strategies being used by communities across the country to address the growing challenge of ensuring diagnostic and treatment services. This study, which 1 am now introducing into the record, revealed: Women are receiving treatment. Both the CDC and the Komen Foundation studies found that treatment was initiated for the vast majority of women who received a diagnosis of breast cancer. While imperfect and needing further resources, the system has been providing treatment for most women who need and want it. Patient navigator and case management services are critical in ensuring follow-up diagnostic and treatment services for women with suspicious screening findings. Case managers determine patient eligibility for assistance programs, including Medicaid and Medicare, identify and negotiate alternative sources of donated care, identify and coordinate provision of support service needs, such as transportation and child care, and assist women in understanding and navigating an increasingly complex health care system. Such services are critical even in areas that have treatment funds and will continue to be necessary if states have an option to provide for treatment services under Medicaid. Provision of services reflects a delicate web of relationships and linkages across public and private organizations and across the federal, state, and 7 local levels. Local communities are meeting the challenge of ensuring treatment services through the dedication of local health care and community professionals who donate services. The need for early detection services exceeds current levels of support. While the NBCCEDP has reached more than 1.3 million women with screening services, this represents only 12-15 percent of the women eligible for services in each state. Currently, state awards under the NBCCEDP range from $1.0 million to $5.0 million annually based on state population, the number of uninsured and underinsured low-income women, state capacity, and other factors. The need for early detection services outweighs current levels of support. Some partnerships between public and private organizations have been established to address the need for educational outreach and screening. Examples include the ENCOREplus program in St. Joseph, Missouri, which addresses barriers women face to health education and access to education and detection services and the Montana Department of Public Health and Human Services screening program. Innovative partnerships are being formed to address local treatment needs. Our study identified ten treatment funds established specifically to meet the needs of low-income uninsured and underinsured women. These included three privately funded (California Treatment Fund, Orange County Susan G. Komen Breast Cancer Foundation, and South Dakota Women's Cancer Network) and seven state-funded programs (Arkansas, Georgia, Rhode Island, Maryland, North Carolina, South Carolina, West Virginia). These initiatives varied considerably in sources of support, structure, services covered, size and other important factors. They combined the unique local strengths of public and private sector partners and all were tailored to local circumstances. These local solutions 8 generally are the result of partnerships between the government and private sector. Actions for Success Efforts to meet the challenge of ensuring early detection and treatment for breast and cervical cancer over the past decade have yielded both successes and lessons. Many women are being diagnosed and treated, case management is critical to ensuring this treatment, the current local infrastructure for ensuring treatment reflects a delicate web of services and relationships, current funding is insufficient to fully address the magnitude of need, and innovative public/private partnerships hold the promise of meeting these challenges for the long-term future. Potential models for meeting the needs of those being diagnosed include: Community treatment models: Expand case management and public/private funds to strengthen and expand existing models. State treatment plans, which currently exist in some states: Model state legislation for treatment programs with federal demonstration project monies. Establish a Ryan White type program, which is used for HIV treatment. Use or enhance existing provisions with respect to state medical necessity provisions under Medicaid. Establish a Medicare adjunct program with a separate funding base. Other comprehensive programs. 9 We realize that the purpose of today's hearing is to discuss H.R. 1070, a bill to amend Title XIX of the Social Security Act to provide medical assistance for women screened and found to have breast or cervical cancer under the BCCEDP program. We highly credit Congressman Lazio and Congresswoman Eshoo for championing this plan and being true allies in the fight against breast cancer. As stated previously, Medicaid assistance is one of several options for dealing with the needs of uninsured, low income women who are treated for breast cancer. Contrary to some accounts we have heard, the Komen Foundation is not opposed to this legislation. We are concerned, however, that any treatment initiative provides a comprehensive and effective solution and reaches those most in need of assistance. Therefore, if serious consideration is to be given to this alternative, as opposed to others, we urge consideration of the following points: Medicaid participation is optional in the proposed bill. States with limited funds in their Medicaid program may be reluctant to cover care for people who would otherwise be ineligible. Medicaid programs may be adverse to participate in an optional program that is diagnosis-specific (that is, only targeted for one disease). Although the mission of the Komen Foundation is focused only on breast cancer, we are aware of the needs of many people with other diseases who are covered by Medicaid. Medicaid varies considerably from state to state. Some states can afford more care than others can. An optional program that requires an initial investment on the part of states may be "picked up" only by the wealthier states. This may contribute to the variation in how a woman may be treated 10 in one state compared to another. Eligibility for a Medicaid program may require women to spend down their resources before they qualify, and it is important that the financial status of patients undergoing treatment not be jeopardized. Medicaid eligibility only for women who are screened through the BCCEDP program does not account for the 85% of women who are eligible for the program but not reached. A certain percentage of these women, who may not be in touch with any healthcare services at all, will nonetheless develop breast cancer. Follow-up for breast cancer is standardly provided for at least five years following treatment. Any program that is medically sound must also provide for follow up. It is critical that any proposed treatment strategy address the full audience and the long-term issues associated with breast cancer treatment. Treatment of breast cancer is required by all who have the disease and wish to be treated, irrespective of where they were screened or where their disease was diagnosed. Women treated must be followed up to ensure the best possible outcomes. This issue is of grave concern to all involved with breast cancer. We must ensure a comprehensive solution, lest we walk away prematurely, with the notion that we have "solved the problem." We are indeed running quickly up this very important ladder; let us be certain that we have it propped against the appropriate building. Thank you very much for your time and attention. 11