u.s. department of health and human …...minutes of the meeting breast and cervical cancer early...

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND PREVENTION National Center for Chronic Disease Prevention and Health Promotion

Division of Cancer Prevention and Control

Meeting of the Breast and Cervical Cancer Early Detection and

Control Advisory Committee November 30 – December 1, 2017

Record of the Proceedings

TABLE OF CONTENTS Page

Minutes of the Meeting Opening Session: November 30, 2017 ............................................................................... 1 Advisory Committee Role and Responsibility ........................................................................ 3 Division of Cancer Prevention and Control Update ................................................................ 5 Overview of Expanded NBCCEDP Strategies to Increase Breast and Cervical Cancer Screening ...................................................................................................................................8 Working with Community-Based Organizations and Employees ......................................... 13 USPSTF Draft Cervical Cancer Recommendation: Impact on NBCCEDP ........................... 16 Group Discussion/Key Recommendations to CDC .............................................................. 19 Public Comment Session .................................................................................................... 21 Closing Session .................................................................................................................. 21 Opening Session: December 1, 2017 ............................................................................... 22 Review of Success with Implementing Evidence-Based Interventions in Health Systems in the Colorectal Control Program ........................................................................................... 22 Expanding Evaluation to Measure Impact and Sustainability of Population-Based Activities .............................................................................................................................. 33 Group Discussion/Key Recommendations to CDC .............................................................. 38 Public Comment Session .................................................................................................... 39 Closing Session .................................................................................................................. 39

Attachment 1: Published Meeting Agenda .................................................................................... i Attachment 2: Roster of the BCCEDCAC Membership .............................................................. vi Attachment 3: Participants’ Directory ......................................................................................... ix Attachment 4: Glossary of Acronyms ......................................................................................... xi

Minutes of the Meeting Breast and Cervical Cancer Early Detection and Control Advisory Committee November 30 – December 1, 2017 ♦ Page 1

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES CENTERS FOR DISEASE CONTROL AND

PREVENTION National Center for Chronic Disease Prevention and Health

Promotion Division of Cancer Prevention and Control

BREAST AND CERVICAL CANCER EARLY DETECTION AND CONTROL ADVISORY COMMITTEE

November 30 - December 1, 2017

Minutes of the Meeting

The U.S. Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC), National Center for Chronic Disease Prevention and Health Promotion, Division of Cancer Prevention and Control (DCPC), convened the meeting of the Breast and Cervical Cancer Early Detection and Control Advisory Committee (BCCEDCAC). The proceedings were held on November 30 - December 1, 2017.

BCCEDCAC is chartered to provide advice and guidance to the HHS Secretary and the CDC Director regarding the early detection and control of breast and cervical cancer. BCCEDCAC’s recommendations focus on national program goals and objectives, implementation strategies, and program priorities (including surveillance, epidemiologic investigations, policy, education and training, information dissemination, and professional interactions and collaborations).

Information for the public to attend the BCCEDCAC meeting via webinar or teleconference was published in the Federal Register in accordance with Federal Advisory Committee Act regulations. All sessions of the BCCEDCAC meeting were open to the public (Attachment 3: Participants’ Directory).

Opening Session: November 30, 2017 Jameka R. Blackmon, MBA, CMP Public Health Advisor Division of Cancer Prevention and Control Centers for Disease Control and Prevention BCCEDCAC Designated Federal Officer Mrs. Blackman began the meeting with a roll call to determine quorum. BCCEDCAC meetings are open to the public and all comments made during the proceedings are a matter of public record. She reminded the BCCEDCAC voting members of their responsibility to disclose any potential


individual and/or institutional conflicts of interest for the public record and recuse themselves from voting or participating in these matters.

CONFLICT OF INTEREST DISCLOSURES

ACET Voting Member (Institution/Organization)

Potential Conflict of Interest

Francisco A.R. Garcia, MD, MPH (Health Services and Chief Medical Officer Pima County)

No conflicts disclosed

Wendy Rosamund Brewster, PhD, MPH (University of North Carolina School of Medicine)


Gloria, D. Coronado, PhD (Kaiser Permanente Center for Health Research)


Lisa C. Flowers, MD (Emory University School of Medicine)


Peggy A. Hannon, PhD, MPH (University of Washington Health Promotion Research Center)


Susan M. Mormann (North Dakota Department of Health)


Wanda K. Nicholson, MD, MPH (University of North Carolina at Chapel Hill Obstetrics and Gynecology)


Richard C. Wender, MD (American Cancer Society)


Ms. Blackmon announced that the 12 voting members and ex-officio members (or their proxies) in attendance constituted a quorum for BCCEDCAC to conduct its business (Attachment 2: Roster of the BCCEDCAC Membership). She called the board meeting to order at 9:10 a.m. EST. The BCCEDCAC members received the agenda for review in advance of the meeting (Attachment 1: Published Meeting Agenda). Francisco A.R. Garcia, MD, MPH Assistant County Administrator for Health Services and Chief Medical Officer Pima County BCCEDCAC Committee Chair Dr. Garcia thanked the attendees and expressed, in advance, his appreciation for their valuable input. Its benefit, he said, can be seen in the important work that has already occurred. He then asked each member to introduce themselves and their agencies, organizations or institutions (Attachment 2: Roster of the BCCEDCAC Membership). Before turning the floor over for presentations, Dr. Garcia reviewed the day’s agenda.


Advisory Committee Role and Responsibility Demetria Gardner Committee Management Specialist Management Analysis and Services Office (MASO) Centers for Disease Control and Prevention The Federal Advisory Committee Act (FACA) provides the legal foundation for establishing and managing federal advisory committees. Congress determined that federal advisory committees are a useful and beneficial means of furnishing expert advice and ideas and diverse opinions to the federal government. Therefore, FACA was enacted to fulfill the following:

• To ensure that committees are establish only when they are determined to be essential • To guarantee that committees provide advice that is relevant, objective and open to the

public • To guarantee that uniform procedures govern the establishment, operation, administration

and duration • To make certain Congress and the public have knowledge of the purpose, membership,

activities and cost Advisory committees should be terminated when they have fulfilled their purpose. FACA defined oversight and management responsibilities. Standing congressional committees review reports of committee activities each year to determine 1) whether the committee is performing a necessary function that is not already being performed, 2) whether a committee should be abolished or merged, or 3) if the responsibilities of the committee should be revised. The President has delegated to the Administrator of the General Services Administration (GSA) the responsibility for oversight for all federal advisory committees. The Administration monitors the Executive Branch compliance with FACA, provides written guidance and FACA training, and submits an annual comprehensive review of committees for the President’s consideration and transmittal to Congress. As a note, CDC has recently completed its annual comprehensive review for all of its committees. Cabinet-level department heads establish administrative and management guidelines for advisory committees to comply with directives of the Administrator of GSA. The guidelines standardize the establishment, procedures, and documentation of advisory committee accomplishments and ensures the public accessibility to reports, records, and other papers of the committee. The federal advisory committees provide advice and recommendations to federal officials on a broad range of issues, which have impact on federal policies and programs. The committees provide the public with an opportunity to participate actively in the decisions made by the federal government. There are two ways to establish a federal advisory committee: by congressional or presidential mandate or at the discretion of the agency’s leadership. Mandated committees are authorized by law or by Presidential executive order. Discretionary committees are established when the agency determines the need for advice and recommendations from experts, who are not federal employees. GSA must approve the establishment of a discretionary committee. The advisory committee is tasked with memorializing a charter and selecting a designated federal official (DFO). The DFO is familiar with the matters under consideration by the committee and is responsible for the day-to-day management of the committee, approval of meeting agendas, and the publication of notices of


meetings to the Federal Register. They must attend all committee meetings. Points of views represented on the committee must be balanced; therefore, memberships are comprised of special government employees (SGE), ex-officio members, and liaison representatives. SGEs are private citizens appointed based on expertise and are subject to “Standards of Ethical Conduct for Employees of the Executive Branch”. The ex-officio members are federal officials who represents their agency as a subject matter expert. Lastly, the liaison representatives are individuals from interest groups, organizations, and affected populations. FACA also outlines the requirements for holding committee meetings. A meeting notice must be published in the Federal Register at least 15 days prior to the meeting to provide the public ample notification. The notice must include the purpose of the meeting, summary of the agenda, time, location, and public access information. The DFO must approve the agenda and be present at all meetings. The public must be given the opportunity to speak or file a written statement. Detailed minutes are to be kept and made available to the public. Official records generated by or for an advisory committee must be retained for the life of the advisory committee. Upon termination of the committee, the records are processed in accordance with the Federal Records Act and Regulations, which are issued by the National Archives and Records Administration. There are times when committees need to perform special tasks. Subgroups can be formed to complete those tasks. The subgroups are called subcommittees or workgroups. A subcommittee’ members include at least one SGE, who serves as a chair. It provides work products to the parent committee. In addition, HHS and CDC policy necessitates its compliance with open meeting requirements of FACA. A workgroup includes at least two members of the parent committee or subcommittee. It gathers information, conducts research, and analyzes issues and facts to be reported to the subcommittee or parent committee. Workgroups are not subject to FACA open meeting requirements. Ms. Gardner provided a couple of examples of CDC’s FACA Committees such as the Advisory Board on Radiation and Worker Health and the Healthcare Infection Control Practices Advisory Committee. FACA ensures that advice provided to the executive branch is objective, accessible, and independent. The advice and recommendations of advisory committees reach the highest levels of U.S. Government.

Duane Stone Conflict of Interest Specialist Management Analysis and Services Office (MASO) Centers for Disease Control and Prevention Mr. Stone’s presentation centered around the reasons for financial disclosure, conflict of interest laws that apply to SGEs, and the Confidential Financial Disclosure Report. The Ethics Reform Act of 1989 requires that each SGE file a financial disclosure report upon appointment and annually thereafter. The financial disclosure shields the SGE and the organization and ensures that the committee’s efforts will be performed without conflicts of interest or the appearance of conflicts. Disclosure permits the agency to determine suitable action to take if a conflict should surface. Mr. Stone then reviewed some criminal statues and their terminology. The 18 U.S.C. 208 Criminal Statute prohibits all employees, including SGEs, from participating in any matter that would directly and predictably affect their financial interests. It also prohibits the employees from acting in government matters that will affect the financial interests of others with whom they have certain


covered relationships; such as, • Spouses; • Minor children; • General partner; • Organizations which the individual serves as an officer, director, trustee, general partner or

employee; and/or • A person or organization with which the employee is negotiating or has an arrangement

concerning prospective employment. He went on to define particular matters, which are matters involving specific parties and are focused on interests of identified persons in specific transactions, like grant proposals; clinical trials; new drug applications; and actions involving legal rights of identified parties. Mr. Stone then contrasted specific party matters to those of party matters of general applicability. The latter affect large, discrete, identifiable class of persons or entities like entire industries, groups of manufacturers, or health care providers. They can result in legislative proposals, regulatory initiatives, and policy development. Mr. Stone ended his presentation by quickly reviewing a few other statues. The 201 Bribery Statute prohibits SGEs from seeking or accepting anything of value in return for being influenced in relation to performance of official duty. The 203/205 Representation Statue prohibits SGEs from receiving compensation for representing someone or something before the agency in any particular matter involving specific parties where the SGE has acted in an official capacity, or where the United States is a party or has a direct interest. Lastly, the 207 Post Employment Statute imposes a lifetime ban on former SGEs representing another person or entity to the government in any matter involving a specific party, if the former SGE participated personally and substantially while serving in the government. Since ethic laws and regulations can be complex, board members were encouraged to contact MASO for guidance should they have questions or concerns.

Division of Cancer Prevention and Control Update Lisa Richardson, MD MPH Director Division of Cancer Prevention and Control Centers for Disease Control and Prevention Dr. Richardson gave the BCCEDCAC members an update on the Division of Cancer Prevention and Control (DCPC). The DCPC sits within the National Center for Chronic Disease and Health Promotion (NCCDPHP) and has four branches within its division: Comprehensive Cancer Control, Cancer Surveillance, Epidemiology & Applied Research, and Program Services. Appropriations for the division come from eight funding lines:

1. Cancer Survivorship and Skin Cancer 2. Cancer Registries 3. Ovarian & Johanna’s Law 4. Breast Cancer in Young Women 5. Comprehensive Cancer 6. Prostate


7. Breast and Cervical 8. Colorectal

Appropriations for CDC cannot be shared across funding lines and can only be used for the funding line to which it was assigned. As an example, survivorship funding is less than $500,000, whereas skin cancer prevention appropriation is $2.1 million. Funding from skin cancer prevention cannot be used for survivorship activities. The graph below shows the funding trajectory from 2004 to 2018. When inflation is taken into consideration, funding is down approximately 30% over the last 10 years.

Figure 1. Cancer Prevention and Control Appropriations FY 2004 - FY 2018 PB

A strategic thinking process was utilized to uncover areas where the division naturally leads. The division has strengths and excels in the areas of data, translation, evaluation, and partnerships. Dr. Richardson shared the strategic plan for the division. The overall goal is for all people to be free of cancer. The division’s aspirations include elimination of preventable cancers; access for all people to get the right care at the right time for the best outcome; and for cancer survivors to live longer, healthier lives. The guiding principles are to do the following:

• Address health disparities • Define expected outcomes upfront • Collaborate • Communicate: tailor to a specific audience

All of this work can be accomplished using the division’s vigor in data, translation, evaluation, and partnerships. DCPC’s four major programs include the National Breast and Cervical Cancer Early Detection Program (NBCCEDP), Colorectal Cancer Control Program (CRCCP), National Comprehensive


Cancer Control Program (NCCCP), and National Program of Cancer Registries (NPCR). Dr. Richardson drilled down more into the NBCCEDP. The program was created by the Breast and Cervical Cancer Mortality Prevention Act of 1990 and provides low-income, uninsured, and underinsured women access to screening and diagnostic services. The program currently funds all 50 states, the District of Columbia, 6 U.S. territories, and 13 American Indian/Alaska Native tribes or tribal organizations. Approximately 2.2 million women were screened the program between 2012-2016, with 25,029 diagnosed with breast cancers, 1,097 diagnosed with cervical invasive cancers, and 15,699 identified with cervical high-grade precancerous lesions. The table below contains the NBCCEDP Program Performance Core Data Quality Indicators.

Breast Cervical Cancer Standards PY 2016 Standards PY2016 % Diagnostic follow-up complete ≥ 90% 95.7% % Diagnostic follow-up complete ≥ 90% 92.5%

% Treatment initiation ≥ 90% 96.9% % Treatment initiation ≥ 90% 91.9%

% >60 days Screening to Diagnosis ≤ 25% 6.7% % >90 days Screening to Diagnosis ≤ 25% 13.7%

% >60 days Diagnosis to Treatment ≤ 20% 8.2% % >90 days Diagnosis to Treatment ≤ 20% 6.9%

(PY = Program Year) Outcomes were measured in the places where the division completes most of its work which includes clinics and healthcare systems. These are also areas where it can gain more traction. Products were also developed as part of the outcomes as well like the 8-page manual, which includes how to measure baseline screening rates. The Colorectal Cancer Control Program initially started in 2009 with a new 5-year cycle of funding that began in FY 2015. The goal for colorectal cancer screening is to increase population level screening rates. All thirty grantees are partnering with health systems to implement priority strategies to increase CRC screening rates. They are expected to implement priority evidence-based interventions recommended by the Community Guide. A key partnership is with The National Colorectal Cancer Roundtable (NCCRT) which is focused on expanding colorectal cancer screening. The Roundtable was founded and continues to be supported by the American Cancer Society (ACS) and CDC. The Roundtable created the 80% by 2018 Initiative, which is being adopted by numerous stakeholders, like the National Cancer Institute (NCI) and the Health Resources and Services Administration (HRSA). The National Comprehensive Cancer Control Program was created in 1998. CDC’s vision for the program is to collaborate with partners to conquer cancer. This is a state-level program, where partnerships are key to leveraging efforts. The program’s Comprehensive Cancer Control National Partnership (CCCNP) is a group of national organizations including CDC, whose aim is to aid comprehensive cancer control coalitions in the states, tribes, territories, and U.S. Pacific Island Jurisdictions. Some of the members of the coalition include ACS, Susan G. Komen, the YMCA, NCI, and the Intercultural Cancer Council. The National Program of Cancer Registries began in 1992. The program’s vision is to increase the completeness, timeliness and usefulness of cancer registry data. These data are currently used to monitor all of the DCPC’s work and includes information from 46 states, D.C., Puerto Rico, the U.S. Pacific Island jurisdictions, and the U.S. Virgin Islands, which in total covers 96% percent of the United States population. The program collects data on approximately 1.6 million new invasive cancer cases each year. Every state must have a cancer registry, and when that data is combined


with the data from the Surveillance, Epidemiology, and End Results Program (SEER), the outcome is a census of cancer cases in the country since 1999. The United States Cancer Statistics (USCS) Data Visualization tool reveals a subset of cancer incidence and mortality data from United States Cancer Statistics (USCS) web-based report. This manageable product allows cancer surveillance data to be easily retrieved by public and cancer control planners. The data can be focused down to the county level. DCPC leads a number of initiatives and campaigns to inform providers and the public about cancer prevention and control such as Screen for Life, Prostate Cancer Awareness, Know:BRCA, and Inside Knowledge. Dr. Richardson highlighted a couple of the initiatives that address DCPC’s third priority, survivorship. The Wellness Demo provides support and guidance to Comprehensive Cancer Control grantees and community-based organizations in the development, implementation, and evaluation of wellness programs for cancer survivors. The demonstration project has three components:

1. Conduct a capacity assessment for a multi-component wellness program 2. Implement an evidence-informed community-based wellness program 3. Conduct process and outcome evaluation to assess adoption of healthy behaviors

The LIVESTRONG at the YMCA Project offers people affected by cancer a safe, supportive environment to participate in physical and social activities. CDC is working to enlarge the program to include 30 new sites. The YMCA will lead evaluation on the flexibility and efficiency of the program in a variety of settings. The division featured 2017 as the year of data. Next year will be the year of communication. To bolster its cancer control efforts, programs, and messages, the division has an active and growing presence on social media. The website is currently being updated. It presently receives roughly 9 to 10 million views a year. Via YouTube, there are 89 videos on the cancer playlist that have received more than 10.3 million lifetime views. The CDC Breast Cancer Facebook page collected more than 20,800 likes since August 2014. Twitter’s @CDC_Cancer has more than 100,000 followers, of which more than 7,100 were new followers in 2017, and the CDC Breast Cancer’s Pinterest Board has 110 pins and more than 5,700 followers. Dr. Richardson has been working on discovering innovative ways to work with patients and to increase dialogue. The Talk to Someone: Triple Negative Breast Cancer effort is an interactive platform that utilizes avatars to convey messages to patients. This work was done with the support of a company called Cognito. Going forward, the goal is to become stronger in all areas. In order to have greater impact there needs to be focused programs that deliver. The division wants to achieve more relevance to all Americans and have greater efficiency by creating a more manageable workload. There also needs to be more cohesion so that every aspect of its work fits together. An effort that will help in this aspect is the National Academy of Science Engineering and Math study on comprehensive cancer control strategies. This will be an expert ad-hoc multidisciplinary committee of approximately 15-20 members, who will examine cancer control efforts in the United States. The committee will make interim recommendations for public and private sector efforts. It will also report on a National Strategy for Cancer Control in the United States. This endeavor will hopefully assist in solidifying roles and decrease replication of work.


Overview of Expanded NBCCEDP Strategies to Increase Breast and Cervical Cancer Screening

Faye Wong, MPH Chief, Program Services Branch Division of Cancer Prevention and Control Centers for Disease Control and Prevention The intent of Ms. Wong’s talk was to present the history of the program. She is a part of the original staff, which created the Breast and Cervical Program in 1991 and returned to the program in 2007. The National Breast and Cervical Cancer Early Detection Program was established by Public Law 101-354, the Breast and Cervical Cancer Mortality Prevention Act of 1990. The law was created to address two concerns, 1) burden of breast and cervical cancer among the U.S. population, particularly those in vulnerable/disadvantaged populations, and 2) the need to increase access for disadvantaged women to breast and cervical cancer screenings. The law dictates that the program serves women who are low income, which at the time was defined as being at or below 250% of the federal poverty level. It also included women who are under- and uninsured for breast and cervical cancer screening. Women who are 50 to 64 years of age are eligible for the breast cancer screening. The Program felt it was important to set priorities populations for screening given that breast cancer incidence and mortality is higher among women age 50 to 64. As for cervical cancer, the eligible population is 21 to 64 years of age. The priority group for this age category are women who are rarely or never screened for cervical cancer. After the law was passed, CDC received approximately $30 million in appropriation to fund a handful of programs across the United States. Today, it funds 70 programs, which includes 50 states, D.C., 13 American Indian/Alaskan Native tribes, and 6 U.S. territories. The programs just received funding for a new 5-year cooperative agreement. Recently added were three new programs, who previously have never received funding. These include the Great Plains Tribal Health Board, American Indian Cancer Foundation from Minnesota, and the Republic of the Marshall Islands. The current appropriations for NBCCEDP is approximately $180 million. In recent years, between $150 million to $156 million has been awarded to grantees. Since 1991, the program has screened over 5.3 million women and provided 12.7 million breast and cervical cancer screenings. It also has diagnosed 74,000 women with breast cancer, 4,000 women with cervical cancer, and 181,000 women with premalignant cervical lesions. These data come from the Minimum Data Elements (MDE). Clinical data is collected on every woman screened by the program. Using MDE data, the program has monitored program quality based on established standards for measuring quality. This includes data on whether grantees are meeting the 75% threshold for serving women 50 to 64 years of age, as well as, whether they are meeting quality standards for serving women who are rarely or never screened for cervical cancer. The program has also established standards for measuring quality such as the length of time between an abnormal screening to the diagnostic testing and from diagnostic testing to referring individuals with cancer into treatment. For many years, grantees have successfully met the CDC standards for program quality. For a long time, the program has recognized that the reach of its services is inadequate. Analysis of census data show that approximately 9.8% of the population of women in the U.S. are eligible for the program, but the program is able to only serve approximately 10.6% of these women. This is due to lack of adequate funding. As for cervical cancer screening, approximately 11.6% of the U.S. population of women are eligible for the program but the program only serves approximately 6.5%


of these women. In 2014, when the Affordable Care Act (ACA) was implemented, breast and cervical cancer screening, as well as colorectal cancer screening, were included in the core benefits package. This provided the program an opportunity to pursue additional ways to increase screening on a population level. To do so, the program has expanded its scope to work with health systems to reach more women across the country for cancer screening. Recommendations/Comments from the BCCEDCAC to NBCCEDP:

• One of the challenges with getting services at community health centers is being able to track women. Screening may occur at one health center, but care may happen at a different site. Tracking becomes a problem when the electronic health records (EHRs) from different sites don’t communicate with one another, thus, follow-up coordination may not occur. HRSA is taking up the issue of access and barriers to gathering accurate data through community-based sites caused by EHR challenges. There’s a need to create health system EHRs that communicate with one another within community health centers.

• Currently, there’s no way to ascertain the quality of shared decisions, so it’s not included as

a quality measure. Determining what the quality measure should be and the differences in interval are still unanswered questions. These should be added topics for the committee members to discuss.

• There’s a billing code for counseling. Encourage use of that billing code as a possible

measure of shared decision-making. It’s also an incentive for behavioral change and a way of evaluating performance. This can help to promote counseling and make it a part of the core care process.

• CDC has opportunities for fostering and pushing for greater integration among its funded

programs. Challenge those funded initiatives to come together with regards to reporting and integrating information into the larger pot. CDC’s funding streams really drive clinical behavior at least in health departments and federally-qualified health centers (FQHCs).

• The health information exchange issue does not have an easy solution, but it is critical to

make sure it’s done correctly. In order to provide a panoramic view of the care given, one has to know how all the areas fit together.

• Dr. Richardson asked the committee members for advice on how to package and sell its

methodologies for tracking and surveillance.

CAPT Jacqueline Miller, MD Medical Officer, Program Services Branch Division of Cancer Prevention and Control Centers for Disease Control and Prevention Before beginning her presentation, Dr. Miller did address a few comments that arose during the group discussion. With regard to counseling, reimbursement is tied to Medicare’s reimbursement rates. As of a couple of years ago, Medicare does not reimburse for counseling.


In light of the recent changes due to the ACA, the program has thought of ways to build on its prior experiences and enhance services that will increase screening among more low-income women. This would require an expanded focus on patients and removing barriers; health systems to decrease missed opportunities; and communities to increase access and demand. All end points should focus on getting women screened, obtaining diagnostic services, and getting women into treatment, if needed. The strategies that would need to be employed to expand the focus would require the following:

• Increase population-based approaches • Work within health system clinics and communities • Implementation of evidenced-based interventions (EBIs) • Address barriers to screening faced by all women • More aggressive outreach to find hard-to-reach women • Put more focus reducing disparities

For the new funding cycle NBCCEDP developed two categories of strategies, primary and cross-cutting. Primary strategies are specific activities to be performed by all grantees that will increase appropriate breast and cervical cancer screening. The cross-cutting strategies are activities that must be done in support of all the primary strategies across the board to achieve outcomes. All programs were asked to incorporate a comprehensive approach within each of their strategies. The comprehensive approach to the primary strategies should include providing direct clinical service delivery, which includes screening and diagnostic services and patient navigation, in order to reach more women. There’s also the implementation of evidence-based interventions within health systems to decrease missed opportunities. This requires partnering with clinics and monitoring screening rates. Another comprehensive approach is community-clinical linkages. These connections will connect women in the community to screening services through working with community organizations, linking women to clinics, and utilizing lay workers. And lastly, incorporating workplace and environmental approaches into the comprehensive plan will result in increased access to cancer screening through policies implemented where women live and work. The comprehensive approaches to address the cross-cutting strategies incorporates cancer data and surveillance. Grantees should use state and local data to inform program planning and monitoring. From the data, they can determine their target populations, reasons for targeting these individuals, ways to reach their population of interest, etc. The comprehensive plan also calls for program coordination. Grantees are encouraged to collaborate with programs to achieve cancer control goals. The days of working in silos are over. Grantees are being asked to reach out to programs like cancer registries, cancer coalitions, tobacco programs, immunization programs, and other chronic disease programs. Moreover, external partnerships with nongovernmental, community-based, governmental, and nontraditional organizations, are encouraged. These partnerships help to leverage resources so that programs can be more efficient across the states to increase the program benefits and reach. Finally, program monitoring and evaluation is a step in the comprehensive approach that should begin at the start of planning and continue throughout as a way of assessing if goals are being met. This includes evaluating activities, processes, impacts, and outcomes. The comprehensive program is held together by program management. Program management is responsible for retaining qualified staff, monitoring program operations and spending, and meeting CDC’s reporting requirements.


NBCCEDP has defined several characteristics of successful programs. These programs must: • Include all primary strategies • Enhance use of data to plan activities • Put more focus on disparities • Find community organizations and/or programs that reach our priority populations • Start slow and build • Evaluate activities to see if they are working

The desire is to allow flexibility and to find ways to ease grantees into the mindset of going past just beyond providing direct screening services. They should look to implement new frameworks and balance direct screening with population-based activities. This can be a challenge. Recommendations/Comments from the Board to NBCCEDP:

• Determine if grantees will benefit from training that teaches them how to be more effective at reaching deeply into the community and at the same time overcoming the intimidation they may feel when reaching out to their target population. There’s a need to increase their capacity and comfort in that area. Hopefully, the National Academy of Science study will create a framework to capture areas like these that are under-measured now. CDC can raise the creditability of these methods and can help push the field along in that matter.

• Peer-to-peer meetings and conferences and funding to provide those opportunities are very helpful in moving the field along. There’s a lot of research science that occurs but it’s critical to translate it into actions that can be useful to grantees to increase uptake of the findings. Researchers should also be present for these meetings because it affords them the opportunity to strategize on where funding should be made available, as they listen to the programs talk about the challenges, gaps, and needs.

• The challenge in focusing on implementing evidence-based interventions and population-based activities is determining what impact has been made. The work needs to be linked to outcomes. It helps to have the clinic-level data coming back, so individuals can see the impact and help them see where they’re making a difference with their work.

• The Bureau of Primary Healthcare reported that the agency is considering adding a UDS measure on breast cancer screening. Currently, seven primary care associations at the state level have selected breast cancer screening as one of their additional measures, as part of the Bureau of Primary Healthcare requirements. Those states are Alabama, Arizona, Utah, Colorado, Massachusetts, Nevada, and West Virginia.

• January is Cervical Health Awareness Month, and it is a prime opportunity to jump on the National Health Observances and share the grantees’ work. HRSA can leverage NBCCEDP’s messages by re-tweeting, re-amplifying, liking them, etc. on social media platforms. Take advantage of this opportunity to distribute data and information.

• A big part of what is happening in the health equity movement is attention to evaluation research. This is understood as creating new methods for assessing the impact of multi-layered, comprehensive strategies that are being put in place, as well as, linking the final outcome or results from implementing those strategies (i.e. As a result of this occurring, this


happened). Also, consider adding a qualitative, contextual piece to the description of what is occurring and how it’s tied to outcomes.

• The National Academy of Science process is also being funded partly by ACS. Chief questions and concerns being raised among the BCCEDCAC and elsewhere can be addressed by the National Academy.

• Five years ago, the ACS embarked on a reorganization effort and decided to organize the field staff along the health system model. Almost all of that work is working with FQHCs. There’s a direct partnership with roughly half of the FQHCs in the United States and an indirect partnership with the remainder. It’s been a very successful model. A paper has been accepted looking at the practices that have resulted in screening rates. The data comes from those who received a change grant from ACS. Although the major focus has been in colorectal cancer screening, the principles are transferrable. Consider how that can be done and build upon it for cervical. Maybe in the committee’s work going forward it can more clearly define the roles of four or five of the organizations, how they contribute, successful models, and ways to leverage and connect those partners. The message of duplicating the strategies of colorectal for use by breast and cervical is also being communicated at the state-level and there’s much more to be uncovered at that level. It’s the first evidence of clinics conducting population-based management.

Working with Community-Based Organizations and Employees Debra Younginer Deputy Chief, Program Services Branch Division of Cancer Prevention and Control Centers for Disease Control and Prevention Ms. Younginer reported on a new funding opportunity that will allow CDC to support grantees as they collaborate with employers and local organizations in targeted population communities. The new funding opportunity announcement (FOA), DP17-1701), contains elements that makes it different from previous FOAs. The FOA contains five strategies. Ms. Younger focused on two strategies in her talk: environmental approaches and community linkages. For environmental approaches, the goal is to increase access to cancer screening through policies and education where women live and work. Part of this approach will also focus on fostering healthy behaviors. Grantees are asked to work with employers in the communities that employ low-income women to develop wellness policies. Grantees are also being asked to work with their local community-based organizations to create an environment where communities can support and promote healthy lifestyles for women. For community linkages, the aim is to connect women in the community to clinical services. These efforts will include informing the targeted population about the breast and cervical program, educate them on the importance of getting cancer screenings, and linking or navigating those women into health systems in their communities. This work will require assistance from external partners particularly through partnership with nontraditional partners in the public and local sector. These partnerships need to include some of the biggest employers in the community that are large national companies or organizations. There have been some challenges in determining ways for grantees to cultivate partnerships on that scale. Grantees are also asked to work with community based organizations, like food banks or housing authorities.


If grantees can establish these partnerships, it will help NBCCEDP to establish community partners who will support the Breast and Cervical Screening Program, reduce barriers and increase access to breast and cervical screening programs, and aid in encouraging healthy lifestyles in target populations. The program is asking the committee to help it answer the following questions, which will aid in the success of the program’s efforts:

• What specific role should CDC play to help our grantees? • What non-traditional partners should we target? • How do we connect to non-traditional partners?

Recommendations/Comments from the Board to DCPC:

• Connections have to be made with the corporate-national-level individuals of these partner organizations or companies. The CDC Foundation could be the vehicle used to reach out to these types of partners. This would be a win-win to them because companies, such as Walmart, provide sub-standard healthcare to their employees, so for CDC to provide screening for breast and cervical cancer can be a win for their brand.

• When talking to large employers, be clear about what you’re asking for on the policy side. This can be the most difficult component because policies are hard to change and it takes a long time to manifest. Grantees could identify some easy wins that would set the stage for policy change. Georgina Castro (CDC), gave the example of utilizing mobile mammography vans at an employer’s site as a small win towards policy change.

• If grantees are going to work with employers, this may also be an opportunity for them to connect women to this program, who are eligible. There will be more of those women among smaller employers. The educational component could be utilized heavier for these women, in addition to linking to programs and services.

• Some employers, like Kaiser, have incentive programs for their employees. That may be a usable example of policy that can be examined.

• The use of the word “policy” sometimes implies something legal to the employer, so care should be taken when it’s used. It would be interesting to engage some of the big employers like Delta and Coca-Cola, which are located in the Atlanta area, on their policies regarding lower-wage workers and access to the types of screening services the program provides. If nothing else, these engagements can help the program discover what is currently available.

• Employers sometimes do not want to admit that they have lower-wage employees. Consider reframing the terminology to “hard to reach” or “hard to engage” employees. It could also be framed as “low-income community” because corporations do have to report to their boards what they have done to help the community and they would be able to speak on how they’re helping to address disparities.

• Consider an economic analyses of the return on investment for a half day of leave to obtain

a mammogram. Perhaps a cost benefit could be found that’s enticing to employers. Dr. Wender noted that there are some fairly good analyses around colon cancer screening and cost saving but not for breast. Mainly because breast cancer screening is effective but does not reduce cost.

• Large employers have to see the benefits to their brand. Conversations have to center

around how these activities can their brand more appealing.


• Serving their employers and giving their employees a chance to serve back is also a hot

issue for large employers. Millennials are looking for an opportunities to serve. There is a CEO gold standard that companies do compete for, and it’s based on the policies that they have implemented. There may be a cooperative way to encourage more people to seek the gold standard. Companies that have a large number of lower paid employees may find this goal hard to reach.

• Another role large employers can play is providing additional funding for this type of work.

Think of involving the CDC Foundation for this endeavor.

• Connecting local funded entities with some streams of philanthropic dollars that come from corporations is a sweet spot to consider.

• There usually are individuals at the corporate level, who are involved in community

engagement and activities. Also ask the corporations to identify women within their organization at different levels, who can partner with the grantees for community engagement and serve as a bridge between the community and the corporations. This will, in turn, create an interface between those in leadership in the corporations and their employees going forward, as well as, open a pathway for more policy changes.

• Another partner to consider are prisons, which contain populations that may be at higher risk

of not obtaining screenings or seeking screening services. CDC and NCI should consider incentivizing them with funding. This can be a complicated space and may call for new funding opportunities to create new models for that space.

• There are many community-based organizations (CBO) that cross between the health sector

and other areas. Look for effective CBOs, regardless of whether they’re in healthcare, that are serving the population you’re interested in and have a discussion with them. Project Home has an innovative model it uses in its work with people with chronic mental illness. Medical/healthcare services are brought to the mental health home. Other organizations to include are those reaching your targeted age and gender groups.

• Health departments that are high-functioning have an understanding of the population they

serve and how to influence them. FQHCs are the cornerstone partners. They are connected with the public and private sector and understand their population. Strategize on how to engage the FQHCs more vigorously and synergize their work.

• Currently, funding is a barrier. Determine who is funding the FQHCs and examine if there’s

a way to link into those opportunities. Be strategic and gain an understanding of the role of the FQHC in its community and examine innovative pilot programs and ways to supplement their work.

• Consider using faith-based entities, women’s organizations, schools, and any other places

where your population frequents. Utilize networking as a way of connecting. Conduct listening sessions with the women to determine their needs, the barriers to accessing services, etc. Some analyses have been done and maybe that work should be synthesized and made actionable. Keeping women at the center is critical to this work.


• Grantees should position themselves with employers as conduits to assist employees in making healthy change versus being enforcers of regulations. It may be an avenue to building partnerships.

• Another partner to consider are health plans. A lot of innovative works occurs when Medicaid

partners with clinics. There’s a false notion that just because a person has Medicaid they are gaining access to care at the clinics, but the data shows that is not the case. About a third have not begun to access care from the clinic they’re assigned to. It’s hard to access new beneficiaries through standards methods like phone calls and emails; therefore, new methods are needed to connect these individuals to services. Libraries may be a partner to consider because of the digital divide. It’s a place where people go to use computers.

• The women working at daycare centers may be used as an extension for increasing

awareness for screening. Ways to engage husband, men and other member of the family is a topic that needs to be discussed.

• The media can be a partner. Use a media outlet that’s appropriate for the target population.

• Conceptualize self-sampling paradigms as a key in reaching people and overcoming barriers

such as stigma, transportation, employment, not being able to access a place of care, etc. Screening, in those concepts, would be something that could be done at home or work. Taking away the issue of loss productivity would increase uptake by employers to allow, for example, 15 minutes to self-sample.

• FQHCs conduct meetings, where HRSA has a presence. Since CDC and HRSA have a

good relationship, coordinate on shared interests and build upon those areas. This is an efficient method for accessing the knowledge of the FQHCs.

USPSTF Draft Cervical Cancer Recommendation: Impact on NBCCEDP

Francisco A.R. Garcia, MD, MPH Assistant County Administrator for Health Services and Chief Medical Officer, Pima County Health Department BSCCEDCAC Committee Chair Dr. Garcia presented the U.S. Preventative Services Task Force’s (USPSTF) draft recommendations for cervical screening. The recommendations can be located on the web at: https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2.

https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2

https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2


Draft: Recommendation Summary

Population Recommendation Grade (What's This?)

Women ages 21 to 65 years

The USPSTF recommends screening for cervical cancer every 3 years with cervical cytology alone in women ages 21 to 29 years. The USPSTF recommends either screening every 3 years with cervical cytology alone or every 5 years with high-risk human papillomavirus (hrHPV) testing alone in women ages 30 to 65 years. See the Clinical Considerations section for the relative benefits and harms of alternative screening strategies for women age 30 years or older.

A

Women older than age 65 years

The USPSTF recommends against screening for cervical cancer in women older than age 65 years who have had adequate prior screening and are not otherwise at high risk for cervical cancer. See the Clinical Considerations section for a discussion of adequate prior screening and risk factors that support screening after age 65 years.

D

Women younger than age 21 years

The USPSTF recommends against screening for cervical cancer in women younger than age 21 years.

D

Women who have had a hysterectomy

The USPSTF recommends against screening for cervical cancer in women who have had a hysterectomy with removal of the cervix and do not have a history of a high-grade precancerous lesion (i.e., cervical intraepithelial neoplasia [CIN] grade 2 or 3) or cervical cancer.

D

The recommendations have programmatic implications. Breast and cervical programs have had to be fairly adaptable because of changes in science as well as clinical practice. The recommendations do, however, present some opportunities to be strategic and to capitalize. The first recommendation presents changes in terms of data collection, what constitutes adequate screening, and the screening modality. What are the tradeoffs for cancer screening in the future in terms of expense, clinical utility, logistics, and operation? Dr. Garcia wanted to have a discussion around those concepts.

• This does not change the intervals for co-testing. The only change is in the five-year option, where HPV testing alone was recommended. ACS feels the draft guideline is a mistake and ACS provided as much feedback to indicate why, but ACS is not saying that it is not going in the direction of having HPV testing alone. This was an extreme case of relying on modeling. There is no actual empirical data on the five-year HPV alone. The trials were on three-year HPV alone. What can be said reliably is that HPV alone out performs pap alone at three years.

https://www.uspreventiveservicestaskforce.org/Page/Name/grade-definitions

https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2#clinical

https://www.uspreventiveservicestaskforce.org/Page/Name/grade-definitions#arec2

https://www.uspreventiveservicestaskforce.org/Page/Document/draft-recommendation-statement/cervical-cancer-screening2#clinical

https://www.uspreventiveservicestaskforce.org/Page/Name/grade-definitions#drec2




• From an implementation standpoint, this will create challenges. The modeling and data review, however, are good. If this is the guideline that stays in place, there will be coverage implications. Payers will only be obligated to cover HPV alone at five years, but not the co-testing. This may push many gynecologist to the three-year option because they won’t like the HPV alone at five years, which is unfortunate. When these are translated into quality measures, there’s a misunderstanding that short-interval testing, like fecal occult blood test, are different from the long-interval option. In the short-interval, the quality measures can be taken out to 18 months, but in the long-interval, there’s no data modeling. The five-year should be viewed as a maximum, which means coverage has to begin at four years. This can be a dicey area.

• CDC should not get in the middle of the fight. Some of the recommendation is consistent

with the previous recommendation. The message should be get screened and get screened regularly. Follow-up and continuing to educate physicians and the public is the biggest challenge, but it will be an important role for CDC to play. More evidence, understanding, and funding is what is needed.

• There was a fair amount of modeling for the recommendation statement with the last

recommendation. The message of getting screened is there but what has changed is how to get screened and what tool should be utilized. USPSTF, NCI, ACS, and CDC should come together to have an overarching common message and CDC can be a part of disseminating that message.

• CDC has to work closely with the grantees on the changes, what’s reflected in the MDEs,

what’s covered, and when. Through the data provided by the grantees, a study of what happens in practice and the implementation process could be conducted.

• The collective message around cancer screening for breast and cervical is another way of

leveraging the community organizations and corporate organizations within communities to join in the message.

• Clients are best served when there’s uniformity of messaging. There’s also a need to

continue to evolve the practice and screening recommendations. Doing this can sometimes cause a tension. A new language will be needed as science changes. In addition, innovative message strategies will need to be utilized as well as strategies for recordkeeping.

• Dr. Taplin did not agree with the concept of forcing a uniform recommendation when the

evidence is otherwise or there’s controversy. It creates more problems when consensus is finally achieved. CDC should disseminate the common message of screening regularly because how to screen is still a learning process. Dr. Wender agreed. When guidelines are released they have a cascade of implications and those implications need to be thought through. The core message should be get screened so that people are not diverted by any of the sideline issues.

• The message of doing what’s best for women based on the best available science should

be communicated frequently as well. A lot of women still think an annual pap smear is the right decision, but science is indicating that it’s not necessary. There’s also a need to provide clarity in terminology. Many people confuse Pap smears with pelvic examinations. They’re not the same.


• Collaborative crosstalk has to occur between agencies because women’s health is complex,

and the lifespan approach takes in consideration many different conditions.

• In order to change physicians’ behaviors, consider pairing women in the community to the physicians in an effort to explain the changes in the recommendations. This can bring a better understanding of the evidence and science that led to the change. This can also help to translate changes to the patient population. Women will drive the practice. Informed consumers can change physicians’ behaviors. There are studies out there to that fact.

• Make sure women understand that the recommendation to move to a three-year screening

was not done for a cost saving. It was an evidence-based decision. Also, clearly define the components of a women’s health visit. Just because screening is now done every three years, it does not negate other components of women’s health that may need to occur more frequently or in the interim.

• If science shows that a molecular-only platform is what’s needed for screening, use caution

in crafting messages regarding the changes from the previous screening practices to the new platform. Also, be sure that everyone understands the change in guideline will not change the experience from the patient’s perspective. The experience of collecting an HPV test as well as the Pap is barely different. What happens with the specimen and what’s ordered is where change is occurring.

Group Discussion/Key Recommendations to CDC

In preparations to close day one of the meeting, the committee engaged in discussions that would ultimately lead to the key recommendations to the program for memorialization. They are captured below. Group Discussion

• There needs to be further information and discussions around shared decision making. What is it? What are the components? How do you document or measure that it’s occurred? A measures is needed that shows that shared decision making is happening.

• Do not overlook the patient component, engagement and education, in shared decision

making. • The program should consider shared decision making as part of the deliverables. In the next

round of FOA, this data element should be collected but not making it as specific as a MDE. Dr. Miller clarified that this can be done prior to a new FOA and does not need to be tied to it.

• The program could engage with NCI to determine what should be measured. Right now,

there’s not a lot of knowledge of the components of shared decision making operationally. Before measuring, shared decision making needs a clearer definition.

• The Substance Abuse and Mental Health Services Administration (SAMHSA) and HRSA

contributed funding to the Center for Integrated Health Solutions. On the center’s website,


there’s information regarding shared decisions making. One of the URLs on the site directs the user to the Health Risk Questionnaire’s (HRQ) website, which has information on a Shared Approach Workshop. There are numerous e-modules, training guides, slides, and videos on shared decision making. So, there are some existing tools being used and catalogues across the government. Consider doing a landscape analysis of what is currently happening in health center programs. Dr. Matoff-Stepp offered her assistance with this task.

• There should be studies to determine what went into shared decision making that supported

the evidence that it’s working and that women make better decisions because of it.

• There does need to be improved communication around the USPSTF recommendations, what it means, how often screening should be occurring, why it’s not every year, and why screening continues to be important. The aim is to get individuals focused on the right part of the message so when recommendations are released, they won’t be as alarming. In addition, provide some good simple education of why it’s safe to use a molecular test alone as testing moves to HPV only versus a Pap smear.

• From a resource management perspective, the program manual rewrite will probably occur

in the future. Some thought needs to be given to creating a new data element that will take into account this type of screening.

• The program should consider employing a media campaign to educate the public on the new

recommendation to screen less frequently. There could be the creation of a guide that will help physicians have the conversation with their patients or a possible education workshop that can be given to the states, where they can use it a train-the-trainer type approach.

• Be wise in how you convey what’s driving the USPSTF’s recommendation and that it’s not

due to cost but due to the science and research. The public’s general perception will be that the recommendation was made as a way for the government to save money.

• Determine if there are ways to partner with other organizations, who are doing messaging,

to enhance the message of the importance of screening and the appropriate intervals.

• Continue to think, engage, and plan strategically for the changes in cervical cancer screening. The committee is encouraging discussion among the effected organizations prior to the release of the final recommendation.

Key Recommendations

♦ The committee recommends NBCCEDP staff to engage vigorously with HRSA colleagues on the development of a breast cancer screening UDS measure. Motioned by Dr. Richard Wender, modified by Dr. Francisco Garcia, and seconded by LCDR Sayeedha Uddin. Motion unanimously passed by the board.

♦ The committee recommends that CDC staff explore the use of shared decision making and its documentation in practice and perhaps its association with outcomes. What are the components of shared decision making that actually are an important part of what happens


and are associated with relevant outcomes? Specifically, direct staff to engage with NCI, HRSA, ACS, and AHRQ.

Motioned by Dr. Steven Taplin, modified by Dr. Francisco Garcia, and seconded by Dr. Leandris Liburb. Motion unanimously passed by the board.

Public Comment Session

Ms. Blackmon opened the floor for public comments; no participants responded.

Closing Session

Dr. Garcia ended day one of the meeting by thanking Ms. Wong and Dr. Blackmon for orchestrating a successful meeting. He also thanked the committee for its rich input. After sharing housekeeping notes, Dr. Blackmon adjourned the meeting.


Opening Session: December 1, 2017

Jameka R. Blackmon, MBA, CMP Public Health Advisor Division of Cancer Prevention and Control Centers for Disease Control and Prevention BCCEDCAC Designated Federal Officer Dr. Blackman welcomed the board members to day two of the meeting. She conducted a roll and announced that there were 12 committee members in attendance constituting quorum. The BCCEDCAC meeting was called to order at 9:05 a.m. EST. Francisco A.R. Garcia, MD, MPH Assistant County Administrator for Health Services and Chief Medical Officer, Pima County BSCCEDCAC Committee Chair Dr. Garcia thanked the attendees for their attendance for the second day of the meeting. The presentations for day two covered colorectal screening and the lessons learned from the field, as well as the evaluation scheme that will be utilized as the program moves into its next iteration. The end goal is to be able to measure impact, which has to be measure objectively and based upon an agreed framework. Review of Success with Implementing Evidence-Based Interventions in Healthcare Systems

in the Colorectal Cancer Control Program Djenaba Joseph, MD, MPH Medical Officer Division of Cancer Prevention and Control Centers for Disease Control and Prevention Dr. Joseph provided the board with an overview of the Colorectal Cancer Control Program (CRCCP) and the year one evaluation results. In 2015, CRCCP funded 30 grantees. The grantees included 23 states, 6 universities, and one tribal organization. The funding contained two distinct components. Component 1 was awarded to all grantees for the purposes of partnering with clinics to implement evidence-based interventions (EBIs) and supportive activities (SA). EBIs include elements such as patient reminders, provider reminders, and provider assessment and feedback. SAs are features such as provider education, patient navigation/community health workers, and health IT. Component 2 was awarded to 6 grantees. The purpose of funding was to provide high quality CRC screening, diagnostics, patient navigation, and other support services to program-eligible patients. Eligibility criteria included the following:

• Un- or underinsured • ≤ 250% of the federal poverty level • 50-64 years-old • Asymptomatic and average risk


The CRCCP Model consists of several standards. The first is the integration of public health activities into primary care clinics. Second, grantees are asked to work with clinics that attend high-need populations, which usually are clinics with depleted screening rates that are helping medically underserved populations. Grantees are encouraged to connect with other partners in their state to help synergize their colorectal cancer (CRC) screening rates. The CRCCP urges grantees to adapt EBIs to fit their population. Lastly, the gathering and usage of high quality data for improving programs is vital. Dr. Joseph reviewed a timeline of where the program started to its present state highlighting accomplishments such as the 1990 establishment of the NBCCEDP, the 2005 to 2009 CRC Screening Demonstration, the emergence of the initial 5-year Colorectal Cancer Control Program (CRCCP) in 2009, and the subsequent DP15-1502 CRCCP in 2015. CDC’s plan shifted in 2009. The 2009 version of CRCCP focused on both screening promotion and provision. Screening promotion required the implementation of policy and systems change that would impact the target population. All grantees also conducted direct cancer screening services using up to one-third of their awarded funds. The newer version is much more prescriptive with Component 1. And, again, six grantees were awarded to complete Component 2. This direction was taken to deal with the issue of reach, which is limited by the funding that’s available. Employing EBIs, such as reminder systems with a population approach, can yield a domino effect causing a larger spread and possible influence. In the 2009 version of the CRCCP, grantees tended to gravitate towards activities that they already performed frequently. Most of the cost was attributed to mass media, patient navigation, small media and outreach. Those things are good but the CRCCP wanted the grantees to focus more on intensive interventions, like provider assessments with feedbacks, client reminders, and structural barriers. Grantees often put these types of activities lower in their priorities; hence, another reason to change the direction of the program so that those activities became a higher priority. In addition, grantees are asked to implement interventions within the clinics. The slide shared below summarizes the differences between the DP09-903 and DP15-1502.


Key Differences between DP09-903 and DP15-1502

DP09-903/DP14-1414 DP15-1502

Broad scope Narrow Scope – easier to show impact

Increase CRC screening in CRCCP- funded states and Tribes to 80%

Increase CRC screening in partner health systems

Broad Partnerships Health system partners with MCOs

Target population = age-eligible individuals throughout the state/tribal region

Target population = age-eligible individuals within select partner health systems

BRFSS data to measure impact Partner health system data to measure impact

Broad EBIs, promising practices, and other strategies across the state/region

4 specific EBIs and select supporting strategies in health systems only

Allowed 30% if funds to support direct service delivery

Six grantees to provide direct service delivery

Evaluation plan not required Evaluation and implementation plans required

Figure 2. Key Differences Between DP09-903 and DP15-1502

Dr. Joseph then shared the Program Year (PY) 1 Evaluation results. This period extended from July 2015 to June 2016. The intent of the evaluation was to answer the following questions:

1. What is the reach of the CRCCP? 2. What EBIs and SAs are implemented in clinics? 3. Are clinic-level screening rates increasing? 4. What is the value of the CRCCP?

The data shared in the presentation came from the clinic-level data as well as the annual grantee survey. CRCCP employed a multiple-method evaluation strategy to gain answers to these questions. Analysis of fiscal data and results from the annual grantee survey were used to determine what the management of a health systems change program looked like. Clinic data collection was utilized to determine the reach of the program, which EBIs and SAs to implement, and the rates of screening. Lastly, cost-effectiveness studies were used to establish the value of investment in a health system change. As of November 2017, grantees have partnered with 206 health systems that are working with 592 clinics. As of April 2017, they were reaching 413 clinics, 5,101 providers and 1,015,874 patients between the ages of 50 to 75. Of the 413 clinics, 72% are FQHCs. Also, 31% of the clinics are serving a high percentages of uninsured patients and 53% of the clinics use FOBT/FIT tests as the primary CRC screening test. CRCCP resources were most often used to enhance existing activities


versus new activities. This is not a research study, so the focus is on determining where money is being spent and the impact of those resources on the screening rates. Demographic data is also being collected regarding the types of clinics, like urban, rural, metro, as well as the size, and types of settings, like FQHC, hospital, or private clinic. The largest increase in screening rates were seen amongst rural clinics, medium-size clinic, and FQHCs. There were some factors identified that helped increase colorectal screening rates. Clinics with internal CRC champions and a CRC screening policy have higher rates of screening than those without. Hopefully, this data will help move the pendulum and enable the grantees to advocate for CRC champions and screening policies. Dr. Joseph ended her presentation with some of the lessons learned from the PY1 Evaluation. CRCCP can now confidently say that the grantees are implementing the program with consistency using the health system change model. Grantees are:

• Effectively integrating public health activities in primary care settings. • Serving defined, high-need populations. • Establishing partnerships to support implementation. • Working towards sustainable health system changes. • Enhancing existing EBIs and SAs and implementing some new ones. • Successfully collecting data for program monitoring and evaluation. • Actively using data for program improvement.

Recommendations/Comments from the committee to CRCCP:

• When you’re in a system, it seems that there’s an opportunity to train the people within the system to measure their activities accurately. It gives CRCCP the ability to do a side-by-side analysis of the impact seen in clinics who implemented the intervention to those who did not. It also provides the system an opportunity to do system-level capacity building. When deciding the next evolution, it has to be about system-level capacity building so that the system does not fall apart. The FQHC community are an important element to accomplishing that goal and it encourages them to engage one another.

• When looking at the HEDIS Measures, there’s very low impact in the 50 to 64-year-old,

commercially-insured population. There’s far more unscreened people being cared for in the commercial settings, yet, Medicare is doing well in that area. If the strategy focuses on the 50 to 64-year-olds, then a whole new set of tools and partners will be needed for these individuals. There are other opportunities that should be explored that may potentiate and leverage the resources the program has already invested.

• A challenge to disseminating in FQHCs are the invisible costs, data collection and

evaluations for which quantifying it is not intuitive. As more FQHC are added, there’s no economy of scale to quantify. Grantees are queried on in-kind elements but don’t know what all those elements are. Determine if there’s a way to measure, describe, or inventory some of the other activities that occur in the clinics. This an important measure to have as part of the evaluation.

• The programs that perform well are those that involve primary care associations. The more

organizations that come to the table for training on this work the better because it helps sustainability. For the states that are receiving funding to do both Components 1 and 2, it


would useful to have a waiver that allows individuals to get enrolled in a program after a positive FIT test. There are challenges in enrolling people before obtaining a FIT test. This will alleviate some of the administrative burden.

Grantee Experiences Eric Lamy CRCCP Program Manager Rhode Island Department of Health Mr. Lamy reviewed the Rhode Island Colorectal Cancer Screening Program. His team is comprised of the following individuals: Brenda Di Paolo, Chief Office of Health Promotion; Eric Lamy, Program Manager; Cindy Ariza, Patient Navigator Coordinator; Junhi Oh, Epidemiologist/Evaluator; and George Andoscia, PSE Expert. Mr. Andoscia is a part of the Comp Cancer Program, and as a result, their group has been able to perform more collaborative work. He is currently working on policy systems and environmental change with health plans, insurers, and the likes. Mr. Lamy provided some background information regarding the program. Roughly 85% of non-Caucasian racial groups are located in Rhode Island’s largest county, Providence. The population of Rhode Island is 1,052,567. Due to its size, Rhode Island makes the ideal piloting location for EBIs. Due to the demographics of the county, program efforts are mainly focused on Providence County. The program works with FQHCs throughout the state, but not all sites. Before receiving funding, screening rates were at 75% in 2014. Compared to aggregate, weighted FQHC UDS rate of 34%, which reveals a huge gap. This is another reason for working primarily with FQHCs. Ms. Di Paolo is the program manager for the Women’s Cancer Screening Program. She has an ongoing relationship with the FQHCs that spans over 20 years. The Women’s Cancer Screening Program opened the door for the colorectal program. Work for both is done under the same contract. Ms. Di Paolo has also worked for the state for over 30 years and has long-term relationships with key stakeholders. The Rhode Island CRC Screening Program collaborates with other programs within the Rhode Island Department of Health and synchronizes its work with community partners to do site visits, to work with pooled funding for resources, and to combine reporting. This makes it easier to work with partners and make them more willing to work in tandem with the program. The program works with 8 FQHCs throughout the state, as well as the Narragansett Indian Health Center, and 9 Health Systems. There are 25 sites in total, with 18 of those sites located in Providence County. Mr. Lamy highlighted some of the program’s most critical partners. The American Cancer Society’s Health Systems Change Manager collaborates frequently with the program. The Colorectal Cancer Advisory Committee has developed a screening infrastructure for uninsured patients. There’s a partnership with the Rhode Island Department of Corrections on a project that screens all age-eligible inmates for colorectal cancer. Through the Roger Williams Medical Center, the program has made provisions for culturally-sensitive patient navigation and colonoscopies to Spanish-speaking FQHC patients in Providence County. Brown University has developed a web-based educational module in multiple languages for the program as well. Implementation of EBIs was done indirectly. He used Lewin’s Equilibrium, which is part of the Lewin’s Change Theory, to explain implementation of the EBIs. As per the theory, in the middle there’s the desired or present state and on one side there are forces for change or driving forces.


On the other side, there are forces that resist change or restraining forces. The impulse is to begin change with the forces of change or driving forces to push towards the desired state; but oftentimes, the most appropriate way to approach is examining the forces that cause resistance to change or the restraining forces. He then reviewed some of the barriers to obtaining the desired state. The first barrier is electronic health records (EHR). It’s a challenge to implement the EBIs recommended by CDC, like patient and provider reminders or provider assessment and feedback without an effective EHR. Rhode Island decided to hire a data consultant to overcome this barrier. The services of the Advocates for Human Potential, Inc. (AHP) were secured through a request for proposal (RFP). Services are paid with pooled funding from the Department of Health’s chronic disease programs. The firm is based in Sudbury, MA and employs over 100 people in 15 states. They lead the national HRSA/BPHC contract to collect and validate Uniform Data Systems (UDS) data and developed the UDS Manual, which provide training and technical support to all 1,500 FQHC grantees and 50 primary care associations, on UDS reporting requirements and current year changes. They are also a HRSA/BPHC-designated EHR and eCQMs subject matter expert. AHP essentially looked at the data lifecycle through all the projects while posing the following questions:

1. An observational “walk through” of the operational and clinical processes • How use of data is incorporated into workflows?

2. A “desktop” workflow analysis using a standardized tool • What are the roles, responsibilities, constraints and best practices?

3. A data validation and reporting review using a standardized tool • How data is collected, validated and reported?

This was a four-hour assessment, which included a two-hour assessment of the EHR functionality and a two-hour workflow analysis looking at element such as clinic protocols and data entry protocols. This process was carried out for all partners. A report of the findings and recommendations was provided to the FQHC, as well as the Rhode Island program. After review, follow-up discussions occur between the FQHC and the program to discuss improvement plans. The second barrier is due to the lack of funding and resources for patient navigators. To assess patient navigation, FQHCs identified staff at each site that would serve as patient navigators. MLW Associates developed and conducted a Patient Navigation Training for all FQHC staff. Training is mandatory for all FQHC staff before invoicing for Patient Navigation. These engagements are an opportunity to build rapport with staff and offer educational and promotional materials. The training is aligned with the Rhode Island Community Health Worker/Patient Navigator Certification. The patient navigator coordinator meets monthly and communicates regularly with FQHC staff, providing educational resources and toolkits. Per the description of the Patient Navigation Training Course, the course curriculum provides “education and skill-based training to participants who will assist clients to overcoming the healthcare barriers that prevent compliance with screening and diagnostic recommendations. The participants will learn to facilitate the navigation of timely access to quality cancer screening and diagnostic tests as well as the initiation of treatment services when recommended.” Mr. Lamy shared a sample of the training curriculum. Initial Training Curriculum Day 1: Tuesday, March 22, 2016: 8am-5pm Module 1 – Communication and Cultural Responsiveness Module 2 – Organizational Skills


Day 2: Tuesday, March 29, 2016: 8am-5pm Module 3 – Documentation Skills Module 4 – Assessment Skills Day 3: Tuesday, April 5, 2016: 8am-5pm Module 5 – Service Coordination Module 6 – Colorectal Health and Colorectal Cancer Day 4: Tuesday, April 12, 2016: 8am-5pm Module 7 – Cervical Health and Cervical Cancer Module 8 – Breast Health and Breast Cancer Two more of these trainings have occurred. Due to the high turnover rate, training will continue. Because of the high numbers of Spanish-speaking patients in the county, the patient navigation for Spanish-speaking patients in Providence County was established at Roger William’s Medical Center. The aim is to reduce a significant barrier to CRC screening in the state. This initiative was created by Dr. Abdul Saied Calvino, a co-chair on Rhode Island’s Partnership to Reduce Cancer. This is a navigation project for Spanish-speaking patients referred to their center for colonoscopies. Its goal is to identify and link all patients who identify Spanish as their language of preference to a Spanish-speaking navigator and care team. Another tool utilized is the Web-Based Educational, Decision-Making Tool. This was created by Dr. Diaz at Brown University. A medical student is currently piloting the tool at an FQHC site in Newport. The tool features concise, up-to-date, easy-to-read information on recommended screening modalities in Spanish and English. More languages will be added in the future. It’s a combination of text, with the option to have read aloud, and video. It is also smart-phone friendly. When discussing CRC screening, a patient navigator can employ this as a tool to underscore important information, while at the same time, acquainting the patient with the tool. At the end of the discussion, the patient navigator can transmit the tool to the patient’s phone and/or email, so they can use it at home to help with decision making. The tool is ideal for millennials, who love digital interfaces. It is currently being piloted at one of the sites. The third barrier is the screening infrastructure for the under- and uninsured. Screening Colonoscopy for the Underserved Population (SCUP) began in February of 2009. A group of local providers and institutions agreed to volunteer their time and expertise. In two years, it expanded to include 9 hospitals, 2 endoscopy centers, and 65 GI physicians and surgeons. The effort resulted in over 250 free screening colonoscopies. Unfortunately, in April of 2012, Dr. DiMase, the founder, passed away. As result, the program came to an end and much of the SCUP program documentation was lost. Rhode Island is now trying to build a SCUP-like program for its population. The Colorectal Cancer Advisory Committee was formed and is comprised of key stakeholders throughout the state, like GI physicians, surgeons, hospital administrators, community organizations, etc. This group is tasked with establishing a screening infrastructure for all uninsured patients at FQHCs. They meet biannually. The CRC Program Manager and American Cancer Society State-Based Health Systems Manager meet regularly to implement action plans developed at Advisory Committee meetings. The screening infrastructure is currently in development.


A new approach to screening is now being employed. FQHCs reached out to all patients eligible, including the uninsured, for CRC screening. It also encompassed high-risk individuals. The approach utilizes FIT as a screening modality for uninsured or underinsured patients and/or as a quality improvement project. The ACS offered funds to FQHCs for this process. Utilizing FIT as initial screening test will greatly reduce referrals for colonoscopies and, as a result, will increase provider buy-in. Abnormal FIT results are then referred to participating GI practices and institutions or hospitals, who have agreed to screen a certain amount of these patients within a given timeframe. A plan with participating hospitals will be established to ensure follow-up care for those screened. The advisory committee members will help to enlist the support of their respective institutions. Monitoring and evaluation can be a challenge because the only hard data that can be reported are UDS screening rates for the health systems partners. This is completed on an annual basis. Therefore, lots of useful data is lost in reporting. Much of the reporting comes in the form of written down processes and process maps. For EBIs, it would be helpful to have varying tiers of efficacy to add to reporting. The patient navigator coordinator meets with patient navigators on a monthly basis. This provides an avenue of measuring some fields from a qualitative standpoint. Recently, the COO of the PCA was present and has agreed to host quarterly quality-improvement and quality-assessment meetings, where all FQHCs are represented by at least their medical director and possibly an IT staff person. The purpose of those meetings is to share best practices and overcome barriers. Below are the UDS screening rates from 2014 to 2016.

Figure 3. USD Screening Rates from 2014 to 2016


One of great concerns was the rate for Providence Community Health Centers. By simply modifying the EHR and updating their medical records, screening rates increased from 6% to 36%, and the rate continues to increase because they’re now able to implement EBIs. Some sites experienced a drop in their screening rates, but this was due to moving from chart-based reporting to EHR reporting. Overall, Rhode Island’s UDS screening rates in 2014 were 1% less than the national average. Their numbers in 2015 and 2016 show that they have exceeded the national average by 4% and 5% each year.

Brian Boisseau CRCCP Program Administrator Kentucky Department for Public Health Mr. Boisseau before giving an overview of the approaches utilized for Kentucky shared some of the geographies in which the FQHCs conduct their work. The Kentucky Department for Public Health (KDPH) is located in the Appalachian Region of Kentucky. Most of the roads go through mountain sides. Because of geography, patients have to depend on friends and family for transportation to sites. Partnership is paramount in Kentucky. KDPH connected together significant organizations, who are already working on increasing colon cancer screening rates and improving health in Kentucky. Below is a list of their implementation as well as coordination or planning partners. Implementation Partners

• Kentucky Regional Extension Center • American Cancer Society - Midwest • Kentucky Cancer Program (U of L and U of K) • Kentucky Colon Cancer Prevention Project

Coordination and Planning Partners

• Kentucky Cancer Consortium (UK) • Kentuckiana Health Collaborative • Kentucky Primary Care Association

Within the grant, the KDPH leads the Implementation Team and ensures the fidelity of the partners’ work within the FOA intent. The department also leads the initial practice workflow and gap assessment, conducts evaluation of work completed under the grant, monitors progress on implementation activities, and submits baseline and annual data. The Kentucky Regional Extension Center leads the practice documentation workflow assessment and serves as an expert consultant in EHR workflows. They also align the work with Meaningful Use and MACRA and conduct PDSA cycles on workflow changes. The American Cancer Society serves as the expert consultants on CRC screening guidelines and workflow best practices. They identify and provide professional development opportunities on CRC best practices and support small media interventions. The Kentucky Cancer Program has the responsibility of working with sites to develop appropriate


small media support materials. They also create community clinical linkage to other CRC activities not directly related to the EBIs. Lastly, the Kentucky Colon Cancer Prevention Project is tasked with providing professional development continuing medical education and access to free FIT kits for uninsured patients. Several activities are occurring within FQHC and healthcare in general, like meaningful use, care delivery, and innovations with the Physician Quality Reporting System and patient-centered medical homes. There are also payment innovations with the Medical Access and CHIP Reauthorization Act (MACRA) and Merit Based Incentive Payments System (MIPS). In addition, there were Stage 2 modified required meaningful use objectives occurring as well. Some of them have changed from the final rule, but there were several elements occurring at the time that health systems had to be aware of in order to avoid penalties. All these events were occurring while the KDPH was attempting to convince the healthcare systems and clinics to work with them to increase the colon cancer screening rates. As a result, KDPH was careful to position themselves as facilitators, who could aid the healthcare systems and clinics, versus being enforcers. KDPH utilized the Path to the Implementation Plan in its work. FQHCs were asked to generate baseline data prior to the initial team visit. An onsite visit with the grant team and clinical staff was conducted to perform an initial workflow analysis. The EBIs are chosen by the FQHC staff based on the workflow assessment. At this time, potential objectives for the EBIs are also identified. There’s an onsite review of documentation in the electronic health record as a form of a gap analysis. Also as a part of this phase, the team reviews the use and functionality of patient and provider reminders and feedback reports. The Implementation Plan is a joint product of the grant team and FQHC staff. The plan is revised as needed. Finalization of the plan has a target completion date of 30 days after the assessment visit. After finalization, the plan is submitted to CDC. Crucial work identified at this point is often related to the EHR workflow and other aspects of health IT. During the active implementation stage, technical assistant visits are made by team members as needed. There’s also monthly data reporting by the FQHC and monthly meetings with the grant team to review progress. Monthly meetings are also held with KDPH and the Kentucky Regional Extension Center to review progress. All the sites that KDPH has worked with have addressed the priority EBIs in some way. Work continues to refine some areas. The implementation process has become a PDSA project to KDPH. This was the department’s first time performing this type of implementation for colorectal screening. One practice was not able to provide baseline data due to challenges in their EHR. Performing a chart review for this site would have been overwhelming. The department now makes sure they have data before initiating the implementation process. Completion of the implementation plan took an excessive amount of time and consumed much of the time from staff, partners and as well as the department itself. Mr. Boisseau summarized some of the implementation challenges as well as successes. They were as follows: Challenges

• Accurate Baseline Data • Scheduling Conflicts • Limiting time demands on clinic staff • Differing level of openness to changes in workflows. • Fear of “looking bad” in different ways – and overcommitting as a result.


• Different levels of expertise in use of EHRs and ability to generate custom reports. • Need for TA in areas not directly aligned to the EBIs

Successes

• Identification of coding/data entry errors that were: o Artificially inflating screening rates o Artificially deflating screening rates

• Educating practices on: o The efficacy of FIT o Options for returning FIT samples

• Connecting CRC screening to: o Flu clinics o Well Woman exams o Annual visits

• Linking our work to what the clinics already do related to PCMH, NQF reporting, MACRA. • Leveraging support by our existing partners.

There were some lessons learned. The implementation process is refining how KDPH recruits new practices. The department also has to learn the language of health care systems, which is different from that of public health. It also learned that data is the biggest challenge and is different at every site. Keeping partners on task with the EBIs is important. The program manual was regularly used as a guide. In addition, KDPH has learned to treat the implementation plan as a living document. The first draft is just that, a first draft. Different issues surface during the implementation process that have to be dealt with in real time, so flexibility and patience is important. The key to success includes partner engagement. KDPH has a very strong team that is in synch with one another’s strengths. Also important are clinic assessments and workflow analyses, which identifies strengths and areas for improvement. The department also solicited the health system’s and clinic’s feedback with regular contact. There are monthly site visits, as well as annual site visits, by the entire team to each of the sites. The department proceeded with the implementation at the pace of health systems, but knew when to push the process along. There must not be a fear of change and all involved must keep a positive attitude and remember the end goal is to reduce cancer and save lives. Recommendations/Comments from the Board to the Grantees:

• HRSA is looking at diabetes work using the Primary Care Association’s cooperative agreements to change the focus of health center compliance and to look at organizational and operational excellence. Although diabetes is a requirement, it has some optional areas, where cervical cancer and colorectal screening can be incorporated. A number of states have selected to work cervical cancer and colorectal screening as their additional topic. Dr. Matoff-Stepp offered to forward the names of the states to Dr. Blackmon.

• Consider using text messages not as a stand-alone but as an adjunct. A meta-analysis has been done on the ways text messages can improve screening for a number of cancers.

• Mr. Lamy said in hindsight, he would have given their data consultant a little less money in

their contract and given the FQHCs the option to apply for funding to work with their own data vendor. Doing this can avoid some of the convolution Rhode Island encountered.


Expanding Evaluation to Measure Impact and Sustainability of Population-Based Activities

Amy DeGroff, PhD, MPH Lead Health Scientist Kristy Kenny, MPH Data Manager Anamika Satsangi, MPH Program Evaluator Division of Cancer Prevention and Control Centers for Disease Control and Prevention Dr. DeGroff, Ms. Kenney, and Ms. Satsangi gave a combined presentation on behalf of the Evaluation Team. The purpose of their presentation was to review the expansion of evaluation measures that would assess the impact and sustainability of population-based activities. Well-made evaluation processes inform program planning and policy making, improve the grantee programs, and increase accountability. The CDC Evaluation Framework is helping the program to identify its stakeholders. The framework includes:

• Engaging stakeholders; • Describing the program; • Focusing the evaluation design; • Gathering credible evidence; • Justifying conclusions; and, • Ensuring use and sharing lessons learned.

NBCCEDP’s stakeholders include groups like the BCCEDCAC, American Cancer Society, and the Department of Health and Human Services. The program is attempting to answer two main outcome questions. One, are breast and cervical cancer screening rates going up in clinics? And, two, how many women are being served and what are their clinical outcomes? To gain these answers, the program is utilizing a multi-level evaluation approach. In this tactic, systematic data is collected across all the grantees and the program. From the grantees, the grantee surveys and program budgets are analyzed annually. Clinic-level data is collected from the health systems clinics. This is done first as a baseline and then annually going forward. Data also comes from the patients, where minimum data elements are gathered twice annually. Dr. DeGroff shared some of the related evaluation questions that can be answered using the different data sources from the evaluation approach. Grantee Survey

• What challenges are grantees facing? • With whom are grantees partnering and for what purpose? • What types and how many provider sites are part of the program?

Approved Budgets

• How are budgets allocated across standard categories and what is the annual spend rate?


• How are staffing configured in terms of numbers and types of staff? • What types of contractors are grantees working with and what do they do?

Clinic-level Data

• What are the characteristics of the clinics and how many patients/providers do they have? • What EBI activities are being implemented? • Are clinic-level screening rates increasing over time?

Minimum Data Elements

• What is the number and demographics of women served through the program? • What screening and diagnostic tests are provided? • What are the final diagnoses for women served through the program?

NBCCEDP has developed a detailed evaluation plan that has been shared with all the grantees. The executive summary has recently been cleared by CDC and will become available on the public-facing website. Another important partner in the evaluation team’s work is their data contractor, Information Management Services, Inc. (IMS). They have been a very valuable asset to the evaluation efforts. IMS has served as the data contractor since 1994. They provide technical assistance and supports all three data collections. They assist with data analyses and develops and maintains data dashboards. Lastly, they produce standardized reports for NBCCEDP. Ms. Kenney gave an overview of the minimum data elements (MDE). The purpose of the MDEs is to collect patient-level screening records on women served through the NBCCEDP in an effort to evaluate whether programs are meeting clinical standards and programmatic priorities. To help the committee gain a better understanding of the data collection, she reviewed the MDE screening cycle. After the initial enrollment and assessment, the cycle beings with a screening test. Testing can include a Pap test, HPV test, mammogram or a clinical breast exam. For the majority of women, the cycle ends with a normal screening result. However, if any of the tests yield an abnormal result, more information is collected for the final diagnosis. If cancer is found, the program collects the treatment initiation data, as well as cancer registry data, through linkages made with central cancer registries. Below is a list of the data elements that make up the MDEs.


Figure 4. What data elements are included in MDEs?

CDC has expanded its definition of women served. Currently, ‘women served’ includes women receiving NBCCEDP-funded screening and/or diagnostic testing. With the MDE v7 revisions, the definition ‘women served’ will also include women who receive NBCCEDP-funded navigation only. In these cases, other non-NBCCEDP resources support screening and diagnostic services. CDC will require an abbreviated MDE record for women who receive NBCCEDP-funded patient navigation only. This better captures NBCCEDP reach and program efforts. The purpose of data review is to identify data quality and program issues. MDE data is known for its high quality. This can be attributed to the semi-annual MDE submission review. The grantees are required to submit, in April and October, their screening records for the program and a submission narrative. The submission narrative includes responses to standard questions that provide CDC more context about the data submission. This information is submitted through NBCCEDP’s secure program website. The next step is for IMS to validate, analyze and compile the data for CDC to review. After this analysis of the data, IMS creates feedback reports and data notes that underscore the data quality or data issues. A conference call is scheduled with the grantee, CDC and IMS to review the data, data reports and data notes. After the call, action items are generated for the grantee to address in the next MDE submission narrative. This is a cyclical process. CDC has selected 11 core indicators from the Data Quality Indicator Goals (DQIG). These indicators are used to evaluate the program. The indicators fall into three categories: priority population, timely and complete follow-up for abnormal screen results, and timely and complete initiation of treatment. Below are the indicators.


Type Indicator Target

Screening priority population

Mammography screening age 50 and older Women never screened for cervical cancer

≥75% ≥20%

Timely and complete diagnostic follow-up of abnormal screening results

Breast diagnosis completed Breast diagnosis completed within 60 days Cervical diagnosis completed Cervical diagnosis completed within 90 days

≥90% ≥75% ≥90% ≥75%

Timely and complete treatment initiated for cancers diagnosed

Breast treatment initiated Breast treatment initiated within 60 days Cervical treatment initiated Cervical treatment initiated within 60 days (Invasive) Cervical treatment initiated within 90 days (CIN2/3)

≥90% ≥80% ≥90% ≥80% ≥80%

Ms. Satsangi ended the presentation with an overview of the clinic-level data. The purpose of the clinic data is to assess program reach, clinic characteristics, EBI implementation, and changes in breast and cervical cancer screening rates in the NBCCEDP partner clinics. Clinic-level data allows the program to assess its reach and define the clinic characteristics. It also has elements that address process implementation. Below are the data variables collected in clinic-level data.


Figure 5. What elements are included in the clinic-level data?

Grantees report their clinic data to CDC using a web-based reporting system. They utilized data collection forms that they’re able to utilize with their clinic partners to ensure complete and accurate data. There’s a data dictionary which is useful to grantees and also can be shared with the clinic partners. Also available is the Measuring Screening Rates Guidance Document. This document outlines how to measure screening rates, has recommendation, as well as numerator and denominator suggestions. There are also clinic-level reports generated like the tableau dashboards, clinic data snapshots, and program highlights. These reports can be shared with stakeholders. There are some supplementary uses for the data. Epidemiologists also use the data to perform secondary analysis. The program also will utilize the data to find complementary groups of EBIs that will leverage the greatest change, as well as, find the number of EBIs that can be implemented and cause change. The data can also be applied to economic analyses. An evaluation toolkit has recently been launched for the grantees. Some of the tools include overall program logic models for the each EBI, a data dictionary, and a data users guide. An evaluator’s list serve is being created to support peer-to-peer exchange across the evaluators. The presentation was concluded with discussion questions the program would like the board to assistance in answering. Those questions were as follows:

• Do you have any recommendations about our evaluation plan? • Are there important contextual factors we should try to capture? • Are there important evaluation or research questions that we should address through

special studies? • Do you have any recommendations about how we can better disseminate and use program

data? Recommendations/Comments from the Board to the NBCCEDP Evaluation Team:


• The denominator of care is a national issue because they can fluctuate. This is an

opportunity for FQHCs to think about how they’re reaching their population and to think beyond who they normally see to discover the population they’re not capturing regularly. Healthy people, who they may not see regularly, could be the ones who would benefit the most from screening. They also incur the FQHCs with the least amount of cost.

• In response to the question on contextual factors, in addition to collecting employment status

also measure employment stability, whether there is annual or sick leave, housing and security, family structure (who else is in the household), social cohesion (possibly using scales and related questions could be utilized as well), and access to transportation. Also, gather more information on those who have never been screened and pulling some of those same contextual components. Doing a sample of these women may make the study more manageable. This is where FQHCs can be important partners. Some of them are using their EHR to collect some of these contextual factors, like housing and security, income, family size, and any criminal justice involvement. The field needs to find ways to better engage with provider systems, FQHCs being the most critical, and how to extract data from them.

• A suggested special study is to examine shared process measures. Different FQHCs may

be willing to participate in process evaluation activities. This may capture information on their challenges and contextual factors of the health system. It’s hard to examine what is happening across the systems because everything is being done independently so it’s not possible to ask the grantees to do process evaluations the same way with and with the same measures. Try to accomplish this study with a subset to gain a more standardize look with a small group.

• It may be helpful to have a short series of questions that could be posed to women who have

not been previously screened. The goal is determine who is not being reached and to be able to characterize those individuals.

• Explore how the data could inform the differential in mortality outcomes. This data could

help characterize quality of care.

• The program could have influence in data quality by recommending the electronic reporting structure. When the data is extracted more uniformly and cohesively from data repositories structures, we’ll ultimately have better information for decision making.

Group Discussion/Key Recommendations to CDC

In preparations to close the meeting, the committee engaged in discussions that would ultimately lead to the key recommendations to the program. No key recommendations were established for day two but there were a number of general suggestions and comments. They are captured below.

• For the colorectal screenings, there’s a need to harvest best practices and issues that impact sustainability of the program. There’s an opportunity to gather that data, as well as the primary challenges, and bring those issues to the forefront to be addressed from a policy perspective.


• There are a mix of measures that clinics are able to choose to avoid the chance of being overburdened with measurements. It would be worthwhile to have a subset of people to examine the effect on the measures from having variations in the denominator of care. A comparison study could be made. Currently, these measures are being viewed as if they are the same, and they’re not.

• There’s a need to affirm and memorialize the idea of moving into EBIs, as grantees, program,

and service providers.

• Determine if this is the time to do a pilot study where some strategic, contextual factors could be asked of women. These data could reveal more nontraditional partners as well as more information on the hardest to reach individuals. This may get the hardest to reach population into the system and unveil more of their characteristics.

• Screening is a process not a test and what should be reimbursed is the process. Reframing

this thinking would shift the field to other ideas like responsibility and the recognition of the responsibility of follow-up after abnormal results and reimbursement for that.

• The Office on Women’s Health (OWH) has a large reach in terms of its social media and it

would welcome the opportunity to magnify any messages disseminated through NBCCEDP.

• Conversations should continue between sister agencies on these issues like the screening process and how to continue to engage FQHCs and OWH.

Public Comment Session

Ms. Blackmon opened the floor for public comments; no participants responded.

Closing Session The terms for a few committee members are ending. Ms. Blackmon recognized the following retiring committee members:

♦ Dr. Wendy Brewster ♦ Dr. Lisa Flowers ♦ Dr. Richard Wender ♦ Dr. Carolyn Muller ♦ Dr. Marcus Plescia

Dr. Wender was the only member able to attend in person and received his certificate of service to the committee. Those in attendance paid honor to Dr. Wender with an applause. Dr. Garcia expressed hope that the committee will find someone with as much expertise and knowledge as Dr. Wender to fill his position. Dr. Blackmon stated that although this marks the end of Dr. Wender’s time on the committee, it will not mark the end of their partnership with ACS. She looks forward to their future engagements and partnering opportunities. Dr. Garcia thanked the program staff, as well as his fellow committee members, for their participation. He looks forward to their meeting next year, which may be a virtual meeting. He


extended the invitation for members to reach out to him or program staff if needed. With no further discussion or business brought before BCCEDCAC, Ms. Blackmon adjourned the meeting at 12:49 p.m. on December 1, 2017.

I hereby certify that to the best of my knowledge; the foregoing Minutes of the proceedings are accurate and complete.

Date Francisco A.R. Garcia, MD, MPH

Chair, Breast and Cervical Cancer Early Detection and Control Advisory Committee

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Attachment 1

Published Meeting Agenda

MEETING OBJECTIVES: Committee members are charged with advising the Secretary, Department of Health and Human Services (DHHS), and the Director, Centers for Disease Control and Prevention (CDC), regarding the early detection and control of breast and cervical cancer. Committee members will discuss and make recommendations regarding national program goals and objectives; implementation strategies; and program priorities.

Day 1: Thursday, November 30, 2017

9:00 A.M. – 9:10 A.M. Opening: Welcome and Roll Call

Jameka Blackmon, MBA, CMP Designated Federal Officer, DCPC, CDC

9:10 A.M. – 9:30 A.M. Introductions of BCCEDCAC Members and Overview of Agenda

Francisco A.R. Garcia, MD, MPH Assistant County Administrator for Health Services and Chief Medical Officer, Pima County Health Department, Arizona BCCEDCAC Committee Chair

9:30 A.M. – 10:30 A.M. Advisory Committee Role and Responsibility

Demetria Gardner Committee Management Specialist MASO, CDC

Duane Stone Conflict of Interest Specialist MASO, CDC

10:30 A.M. – 11:00 A.M. Division of Cancer Prevention and Control Update

Lisa Richardson, MD, MPH Director, DCPC, CDC

11:00 A.M. – 11:15 A.M.

Break

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11:15 A.M. – 12:00 P.M. Overview of Expanded NBCCEDP Strategies to Increase Breast and Cervical Cancer Screening

Faye Wong, MPH Chief, Program Services Branch, DCPC, CDC

Jacqueline Miller, MD Medical Officer, DCPC, CDC

Group Discussion


12:00 P.M. – 1:00 P.M. Lunch

Café 106

1:00 P.M. – 2:00 P.M. Working with Community-based Organizations and Employers

Debra Younginer Deputy Chief, Program Services Branch, DCPC, CDC

Group Discussion


2:00 P.M. – 3:00 P.M. USPSTF Draft Cervical Cancer Recommendation: Impact on NBCCEDP

Group Discussion


3:00 P.M. – 3:15 P.M. Break

3:15 P.M. – 4:30 P.M. Group Discussion


4:30 P.M. – 4:45 P.M. Public Comment


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4:45 P.M. – 5:00 P.M. Wrap-Up/Announcements



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Day 2: Friday, December 1, 2017

9:00 A.M. – 9:15 A.M. Highlights and Review: Day 1


9:15 A.M. – 10:45 A.M. Review of Success with Implementing Evidence-based Interventions in Health Systems in the Colorectal Cancer Control Program

Djenaba Joseph, MD, MPH Medical Officer, DCPC, CDC

Grantee Example

Eric Lamy CRCCP Program Manager, Rhode Island Department of Health

Grantee Example

Brian Boisseau CRCCP Program Administrator, Kentucky Department for Public Health

Group Discussion


10:45 A.M. – 11:00 A.M. 11:00 A.M. – 12:00 P.M.

Break

Expanding Evaluation to Measure Impact and Sustainability of Population-Based Activities

Amy DeGroff, PhD, MPH Lead Health Scientist, DCPC, CDC

Kristy Kenney, MPH Data Manager, DCPC, CDC

Anamika Satsangi, MPH Program Evaluator, DCPC, CDC

Group Discussion


12:00 P.M. – 12:30 P.M. Group Discussion/Key Recommendations to CDC

Francisco A.R. Garcia, MD, MPH

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Assistant County Administrator for Health Services and Chief Medical Officer, Pima County Health Department, Arizona BCCEDCAC Committee Chair

12:30 P.M. – 12:45 P.M. Public Comment


12:45 P.M. – 1:00 P.M. Review of Meeting, Wrap Up/Announcements/Adjourn



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Attachment 2 Roster of the BCCEDCAC Membership

CHAIR Francisco A.R. Garcia, MD, MPH Assistant County Administrator for Health Services and Chief Medical Officer Pima County 3950 S. Country Club Road Tucson, AZ 85714 Phone: (520) 724-7931 Email: [email protected] Term: 10/10/2016 - 3/31/2020

EXECUTIVE SECRETARY Jameka Reese Blackmon, MBA, CMP Designated Federal Officer Division of Cancer Prevention and Control Centers for Disease Control and Prevention 4770 Buford Highway, NE, Mailstop F76 Atlanta, GA 30341 Phone: 770-488-4740 Fax: 770-488-3230 Email: [email protected]

MEMBERS

Wendy Rosamund Brewster, PhD, MPH Associate Professor Department of Obstetrics and Gynecology University of North Carolina School of Medicine Physicians Office Building B103 Chapel Hill, NC 27599 Phone: (919) 843-5165 Fax: (919) 843-7364 Email: [email protected] Term: 8/28/2014 - 3/31/2018 Gloria, D. Coronado, PhD Mitch Greenlick Endowed Senior Investigator in Health Disparities Research Kaiser Permanente Center for Health Research 3800 North Interstate Avenue Portland, OR 97227 Phone: (503) 335-2427 Fax: (503) 335-2424 Email: [email protected] Term: 11/02/2016 - 3/31/2020

Lisa C. Flowers, MD Associate Professor Department of Obstetrics and Gynecology Emory University School of Medicine 69 Jesse Hill Jr. Drive SE, Glenn, Room 409 Atlanta, GA 30303 Phone: (404) 778-1380 Fax: (404) 778-1382 Email: [email protected] Term: 11/16/2016 - 3/31/2018 Peggy A. Hannon, PhD, MPH Associate Professor University of Washington Health Promotion Research Center 1107 NE 45th Street Suite 200 Seattle, WA 98105 Phone (215) 456-3546 Fax (215) 455-1933 Email: [email protected] Term: 10/03/2016 - 3/30/2020

mailto:[email protected]

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Carol Heiduck Lee, MD Attending Physician Memorial Sloan-Kettering Cancer Center Department of Diagnostic Radiology 1275 York Avenue New York, NY, 10021 Phone: (646) 888-4513 Fax: (646) 888-4515 Email: [email protected] Term: 10/12/2016 – 3/31/2020 Susan M. Mormann Director North Dakota Department of Health Division of Cancer Prevention and Control 600 East Boulevard Avenue Dept. 301 Bismarck, ND 58505-0200 Phone: (701) 328-2472 Fax: (701) 328-2036 Email: [email protected] Term: 10/07/2016 - 3/31/2020 Carolyn Muller, MD Director Division of Gynecologic Oncology University of New Mexico, Cancer Center 1 University of New Mexico MSC 07 4025 Albuquerque, NM 87131 Phone: (505) 925-0560 Fax: (505) 272-4039 Email: [email protected] Term: 08/27/2014 - 03/31/2018 Wanda K. Nicholson, MD, MPH Professor University of North Carolina at Chapel Hill Obstetrics and Gynecology 100 Manning Drive Chapel Hill, NC 27599 Phone: (919) 843-7851 Fax: (919) 966-6001 Email: [email protected] Term: 12/9/2016 - 03/31/2020

Marcus Plescia, MD, MPH Chief Medical Officer Association of State and Territorial Health Officers (ASTHO) c/o CDC Foundation 600 Peachtree Street, NE Suite 1000 Atlanta, GA 30308 Phone: (571) 527-3147 Email: [email protected] Term: 08/24/2014 - 03/31/2018 Joanne Schottinger, MD* Assistant Medical Director for Quality and Clinical Analysis Southern California Permanente Medical Group 393 E. Walnut Street Pasadena, CA, 91188 Phone: (626) 676-2025 Fax: (626) 405-6646 Email: [email protected] Term: 04/01/2017 – 03/31/2021 Richard C. Wender, MD Chief Cancer Control Officer American Cancer Society 250 Williams Street Suite 600 Atlanta, GA 30303 Phone: (404) 329-4913 Email: [email protected] Term: 11/30/2016 - 03/31/2018 Bethany L. Zell* Program Director Pink Aroostook 163 Van Buren Road Suite 1 Caribou, ME 04736 Phone: (207) 498-1361 Fax: (207) 498-1149 Email: [email protected] Term: 04/01/2017 - 03/31/2021 Vacancy *Members who have been appointed, however, HR processing has been delayed due to hiring freeze

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EX-OFFICIO MEMBERS Centers for Disease Control and Prevention Leandris C. Liburd, PhD., MPH, MA Director, Office of Minority Health and Health Equity Office of Women’s Health Centers for Disease Control and Prevention 4770 Buford Hwy, Mailstop K77 Atlanta, GA 30341 Phone: 770-488-8343 Fax: 770-488-8140 Email: [email protected]

Centers for Medicare and Medicaid Services Richard E. Wild, MD, JD, MBA, FACEP Chief Medical Officer CMS, Atlanta Regional Office 61 Forsyth St. Suite 4T20 Atlanta, GA, 30303 Phone: 404-562-7160 Email: [email protected]

Food and Drug Administration David L. Lerner, MD Medical Officer Division of Mammography Quality Standards 10903 New Hampshire Ave. White Oak Bldg. 66 Room 4448 Silver Spring, MD 20993 Phone: 240-402-5018 Email: [email protected]

Health Resources and Services Administration Sabrina A. Matoff-Stepp, PhD Director, Office of Women’s Health Health Resources and Services Administration 5600 Fishers Lane, Room 11N-02 Rockville, MD 20857 Phone: 301-443-8664 Fax: 301-443-8587 Email: [email protected]

Indian Health Service Tina A. Tah, RN/BSN/MBA CAPT, USPHS Senior Nurse Consultant, Public Health Nursing 5600 Fishers Lane Rockville, MD 20857 Phone: 301-443-0038 Email: [email protected] National Institutes of Health Stephen Taplin, MD, MPH Senior Advisor in Cancer Screening Center for Global Health National Cancer Institute National Institute of Health P.O. Box 57 St. Helena, CA 94574 Phone: 240-276-6947 Email: [email protected] Office on Women’s Health, DHHS LCDR Sayeedha Ghori Uddin, MD, MPH Senior Public Health Analyst Division of Policy and Performance Management 200 Independence Ave. Room 712E Washington, DC 20201 Phone: 202-690-7650 Email: [email protected]




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Attachment 3 Participants’ Directory

BCCEDCAC Members Present Francisco A.R. Garcia, MD, MPH Health Services and Chief Medical Officer Pima County Gloria, D. Coronado, PhD Kaiser Permanente Center for Health Research Lisa C. Flowers, MD Emory University School of Medicine Peggy A. Hannon, PhD, MPH University of Washington Susan M. Mormann North Dakota Department of Health Wanda K. Nicholson, MD, MPH University of North Carolina at Chapel Hill Richard C. Wender, MD American Cancer Society BCCEDCAC Members Absent Wendy Rosamund Brewster, PhD, MPH University of North Carolina School of Medicine Carol Heiduck Lee, MD Memorial Sloan-Kettering Cancer Center Carolyn Muller, MD University of New Mexico Cancer Center Marcus Plescia, MD, MPH Association of State and Territorial Health Officers (ASTHO) c/o CDC Foundation

Joanne Schottinger, MD* Southern California Permanente Medical Group Bethany L. Zell* Pink Aroostook BCCEDCAC Ex-Officio Members Present Leandris C. Liburd, PhD., MPH, MA Centers for Disease Control and Prevention David L. Lerner, MD U.S. Food and Drug Administration Sabrina A. Matoff-Stepp, PhD Health Resources and Services Administration CAPT Tina Tah, RN, BSN, MBA Indian Health Services Stephen Taplin, MD, MPH National Cancer Institute, National Institutes of Health LCDR Sayeedha Ghori Uddin, MD, MPH Department of Health and Human Services Richard E. Wild, MD, JD, MBA, FACEP Centers for Medicare and Medicaid Services BCCEDCAC Ex-Officio Members Absent (None)

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BCCEDCAC Designated Federal Officer Jameka R. Blackmon, MBA, CMP DCPC Public Health Advisor

CDC Representatives Demetria Gardner Duane Stone Lisa Richardson, MD, MPH Faye Wong, MPH CAPT Jacqueline Miller, MD Debra Younginer CDR Djenaba Joseph, MD, MPH Amy DeGroff, PhD Kristy Kenney, MPH Anamika Salsangi, MPH Carolyn P.R. Headley, MSPH Demetrius Parker

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Attachment 4 Glossary of Acronyms

Acronyms Description ACA Affordable Care Act ACS American Cancer Society BCC Breast and Cervical Cancer BCCEDCAC Breast and Cervical Cancer Early Detection and Control Advisory Committee CCCP Comprehensive Cancer Control Program CDC Centers for Disease Control and Prevention CoAgs Cooperative Agreements CRCCP Colorectal Cancer Control Program DCPC Division of Cancer Prevention and Control EBIs Evidence-Based Interventions FOAs Funding Opportunity Announcements FQHCs Federally Qualified Health Centers HHS U.S. Department of Health and Human Services HPV Human Papillomavirus HRSA Health Resources and Services Administration IPERIA Improper Payments Elimination and Recovery Improvement Act MDEs Minimum Data Elements MQSA Mammography Quality Standards Act NBCCEDP National Breast and Cervical Cancer Early Detection Program PGO Procurements and Grants Office SDOH Social Determinants of Health USPSTF U.S. Preventive Services Task Force

u.s. department of health and human …...minutes of the meeting breast and cervical cancer early...

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