Ann Surg Oncol DOI 10.1245/s10434-014-3711-9
ORIGINAL ARTICLE – BREAST ONCOLOGY
Can Breast Surgeons Provide Breast Cancer Genetic Testing? An American Society of Breast Surgeons Survey Peter D. Beitsch, MD, FACS1 and Pat W. Whitworth, MD2 1
Dallas Breast Center and Dallas Surgical Group, Dallas, TX; 2Nashville Breast Center, Nashville, TN
ABSTRACT Background. Whether breast cancer surgeons are adequately trained, skilled, and experienced to provide breast cancer genetic assessment, testing, and counseling came under debate in September 2013 when a major third-party payer excluded nongenetics specialists from ordering such testing. A literature search having failed to uncover any study on breast surgeons’ skill and practice in this area, the American Society of Breast Surgeons (ASBrS) surveyed its members on their experience with the recognized crucial components of such testing. Methods. In late 2013, ASBrS e-mailed a link to an online questionnaire to its U.S. members (n = 2,603) requesting a self-assessment of skills and experience in genetic assessment, testing, interpretation, and counseling. After approximately 6 weeks, the results were collated and evaluated. Results. By January 2, 2014, 907 responses (34.84 %) had arrived from breast surgeons nationwide working in academic settings (20 %), solo or small group private practice (39 %), large multispecialty groups (18 %), and other settings. More than half said they performed 3-generation pedigrees, ordered genetic testing, and provided pre- and posttest counseling. Most noted that they would welcome continuing educational support in genetics. Conclusions. Currently the majority of breast surgeons provide genetic counseling and testing services to their patients. They report practices that meet or exceed recognized guidelines, including the necessary elements and processes for best practices in breast cancer genetics test counseling. Because breast cancer genetic testing is grossly
Ó Society of Surgical Oncology 2014 First Received: 6 March 2014 P. W. Whitworth, MD e-mail: [email protected]
underutilized relative to the size of the U.S. BRCA mutation carrier population, these appropriate services should not be restricted but rather supported and expanded. The advent of commercial BRCA1/2 testing for women with potential high familial cancer risk some 2 decades ago provided clinicians and patients with important new tools for decision making.1 Recently, the number of testable genes associated with breast cancer has expanded, deepening the complexity of interpretation and counseling. As the use of such testing has proliferated, professional medical associations, health insurance providers, and other stakeholders have offered guidelines on skills and practices required to select candidates for testing, order tests, interpret results, and counsel patients before, during, and after testing. The education, skill, and practices of the breast cancer surgeon community regarding genetic testing and counseling have not been formally assessed. Various criteria have appeared establishing who is eligible to perform these services, thereby restricting the number and types of health care providers who may order testing and thus potentially decreasing access for those who would otherwise qualify for genetic testing. One set of recommendations, created under the aegis of the American College of Surgeons, was issued by the National Accreditation Program for Breast Centers (NAPBC), which is ‘‘a consortium of national, professional organizations focused on breast health and dedicated to the improvement of quality care and outcomes of patients with diseases of the breast through evidence-based standards and patient and professional education.’’2 Among health professionals deemed appropriate to provide such services are a ‘‘board certified/board eligible physician or other trained healthcare professional with expertise and experience in cancer genetics (defined as providing cancer risk assessment on a regular basis) employing a model that includes both pretest and posttest counseling.’’3
P. D. Beitsch, P. W. Whitworth
In contrast, third-party payers have begun to restrict breast surgeons from ordering genetic testing, accepting only ‘‘an independent specialty trained genetics professional such as a medical geneticist or a genetic counselor who is an American Board of Medical Genetics or American Board of Genetic Counseling certified genetic counseling professional who is unaffiliated with a genetic testing lab performing the test(s).’’4 This policy change has been opposed by major oncology societies such as the American Society of Clinical Oncology on the basis of the concern that it would restrict access.5 Access to and utilization of appropriate breast cancer genetic testing are critical health care issues because of the magnitude of the problem they address. Drohan et al. calculated that only 30 % of more than 35,000 breast cancer patients harboring deleterious BRCA mutations had been so identified. Moreover, the same analysis demonstrated that only 5–6 % of the more than 220,000 as yet unaffected carriers in the U.S. population had been identified and informed.6 Underutilization or underdetection is even more critical when one considers that effective prevention of breast cancer in the expected 50–80 % of such women who will develop breast cancer is widely available, and that nearly all BRCA-based cancers require systemic adjuvant chemotherapy in addition to surgery. To better assess the current practice of breast surgeons in genetic testing ordering, the American Society of Breast Surgeons (ASBrS) conducted a survey of its U.S. members.
with which they did so; (5) whether they obtained C3-generation pedigrees for patients’ family history of cancer; (6) whether they felt confident about the counseling they provided before and after the test; (7) whether they would like the ASBrS to offer educational support and credentialing for BRCA testing; (8) whether insurance approval for testing was easy or burdensome; (9) their practice in referring patients to a genetic counselor; (10) how often patients kept their appointments with genetic counselors; and (11) whether they had ever ordered expanded genetic mutation panels. Responses were accepted for approximately 6 weeks. By the cutoff date, 907 (34.84 %) of 2,603 surveys were completed. Seventeen additional surveys were returned as undeliverable. All 907 responses were deemed suitable for analysis and included.
METHODS
The majority of breast surgeons said that they ordered BRCA testing (Fig. 1). However, 68 % of breast surgeons in academic practice said their patients’ tests were ordered by genetic counselors.
On November 25, 2013, the office of the ASBrS in Columbia, Maryland, sent an anonymous survey (Supplementary Data) via e-mail to its 2603 members (among approximately 3,000 members worldwide) who reside in the United States and who had provided a valid e-mail address as listed in the current member database. The e-mail message contained a link to the questionnaire administered via SurveyMonkey (Palo Alto, CA), a free online survey and questionnaire tool. The content and distribution methods of the questionnaire were reviewed and approved by the ASBrS Research Committee. Followup messages were sent to nonrespondents after 2, 7, and 8 days. The methods were similar to those used for previous ASBrS member surveys, conducted approximately once a year, on various topics.7,8 Survey recipients were asked 11 questions: (1) type of practice; (2) whether they or others tended to order BRCA testing for their patients; (3) under which guidelines they based their decisions to order such tests; (4) the frequency
RESULTS Survey Response and Demographics By January 2, 2014, 907 responses (35 % of members queried) had been received from clinicians throughout the United States working in solo or small group private practices (39 %), hospital-employed breast centers (21 %), academic settings (20 %), large multispecialty groups (18 %), and other settings (2 %). Who Orders the Test
How Often BRCA Tests are Ordered Regarding the frequency of ordering BRCA testing, 45 % said they did so a few times a month; 20 %, several times a week; and 16 %, a few times a year. One fifth (20 %) said they ordered genetic tests rarely or never. When respondents order BRCA testing, a strong majority (61 %) said they based their decision on guidelines from the National Comprehensive Cancer Network (NCCN). Pedigrees of C3 Generations Obtaining a C3-generation pedigree is ‘‘standard’’ for 63 % of respondents (Fig. 2). Others replied that they did so only when considering BRCA testing (15 %) or ‘‘rarely,
ASBrS Genetic Testing Survey
When my patients have BRCA testing it is usually ordered:
Are you confident in your ability to provide appropriate pre-and post-BRCA test counseling?
9.4 % (85)
36.6 % (328)
35.1 % (316)
11.8 % (106)
54.0 % (486)
51.6 % (463)
1.4 % (13)
By me By the medical oncologist By a genetics counselor
By the primary care doctor By someone else
yes, I do so as a standard practice
no
yes, but this is usually done by someone else
FIG. 3 Confidence in genetic counseling skills
FIG. 1 Who orders testing
I obtain a 3 (or more) generation pedigree for my patient’s family history of cancer
14.9 % (132)
Expanded Genetic Mutation Panels More than one third of respondents (39 %) said they had ordered expanded genetic mutation panels; most (61 %) had not. Confidence
20.3 % (179)
63.3 % (559) 1.5 % (13)
More than half of respondents (52 %) reported confidence in their ability to provide appropriate pre- and posttest BRCA test counseling (Fig. 3). More than one third (37 %) said that although they were confident providing such counseling, it was usually done by someone else. Twelve percent of breast surgeons said they lacked sufficient knowledge to perform counseling. Desire for Education
as a standard
rarely, but I can and do when appropriate
only if I am considering BRCA testing
don’t know what this is
Asked whether they would like the ASBrS to offer educational support in genetic testing, most said yes (46 %, ‘‘strongly agree’’; 39 %, ‘‘agree’’; total, 84 %). A minority replied ‘‘disagree’’ (12 %) or ‘‘strongly disagree’’ (4 %).
FIG. 2 Personal practice in obtaining C3-generation pedigree
Ease of Insurance Approval
but I can and do when appropriate’’ (20 %). Therefore, more than 90 % of breast surgeon respondents reported being willing and able to perform 3-generation pedigrees for their patients, a main concern for insurance companies.
Obtaining insurance approval for testing ‘‘is burdensome, but we get it done,’’ according to 58 % of respondents. ‘‘Easy and straightforward’’ characterized the process for 26 %, whereas 9 % considered insurance
P. D. Beitsch, P. W. Whitworth
Do your patients make and keep their genetic counselor appointments?
61.0 % (544) 16.8 % (150)
1.1 % (10) 14.6 % (130)
never
>50%
ORIGINAL ARTICLE – BREAST ONCOLOGY
Can Breast Surgeons Provide Breast Cancer Genetic Testing? An American Society of Breast Surgeons Survey Peter D. Beitsch, MD, FACS1 and Pat W. Whitworth, MD2 1
Dallas Breast Center and Dallas Surgical Group, Dallas, TX; 2Nashville Breast Center, Nashville, TN
ABSTRACT Background. Whether breast cancer surgeons are adequately trained, skilled, and experienced to provide breast cancer genetic assessment, testing, and counseling came under debate in September 2013 when a major third-party payer excluded nongenetics specialists from ordering such testing. A literature search having failed to uncover any study on breast surgeons’ skill and practice in this area, the American Society of Breast Surgeons (ASBrS) surveyed its members on their experience with the recognized crucial components of such testing. Methods. In late 2013, ASBrS e-mailed a link to an online questionnaire to its U.S. members (n = 2,603) requesting a self-assessment of skills and experience in genetic assessment, testing, interpretation, and counseling. After approximately 6 weeks, the results were collated and evaluated. Results. By January 2, 2014, 907 responses (34.84 %) had arrived from breast surgeons nationwide working in academic settings (20 %), solo or small group private practice (39 %), large multispecialty groups (18 %), and other settings. More than half said they performed 3-generation pedigrees, ordered genetic testing, and provided pre- and posttest counseling. Most noted that they would welcome continuing educational support in genetics. Conclusions. Currently the majority of breast surgeons provide genetic counseling and testing services to their patients. They report practices that meet or exceed recognized guidelines, including the necessary elements and processes for best practices in breast cancer genetics test counseling. Because breast cancer genetic testing is grossly
Ó Society of Surgical Oncology 2014 First Received: 6 March 2014 P. W. Whitworth, MD e-mail: [email protected]
underutilized relative to the size of the U.S. BRCA mutation carrier population, these appropriate services should not be restricted but rather supported and expanded. The advent of commercial BRCA1/2 testing for women with potential high familial cancer risk some 2 decades ago provided clinicians and patients with important new tools for decision making.1 Recently, the number of testable genes associated with breast cancer has expanded, deepening the complexity of interpretation and counseling. As the use of such testing has proliferated, professional medical associations, health insurance providers, and other stakeholders have offered guidelines on skills and practices required to select candidates for testing, order tests, interpret results, and counsel patients before, during, and after testing. The education, skill, and practices of the breast cancer surgeon community regarding genetic testing and counseling have not been formally assessed. Various criteria have appeared establishing who is eligible to perform these services, thereby restricting the number and types of health care providers who may order testing and thus potentially decreasing access for those who would otherwise qualify for genetic testing. One set of recommendations, created under the aegis of the American College of Surgeons, was issued by the National Accreditation Program for Breast Centers (NAPBC), which is ‘‘a consortium of national, professional organizations focused on breast health and dedicated to the improvement of quality care and outcomes of patients with diseases of the breast through evidence-based standards and patient and professional education.’’2 Among health professionals deemed appropriate to provide such services are a ‘‘board certified/board eligible physician or other trained healthcare professional with expertise and experience in cancer genetics (defined as providing cancer risk assessment on a regular basis) employing a model that includes both pretest and posttest counseling.’’3
P. D. Beitsch, P. W. Whitworth
In contrast, third-party payers have begun to restrict breast surgeons from ordering genetic testing, accepting only ‘‘an independent specialty trained genetics professional such as a medical geneticist or a genetic counselor who is an American Board of Medical Genetics or American Board of Genetic Counseling certified genetic counseling professional who is unaffiliated with a genetic testing lab performing the test(s).’’4 This policy change has been opposed by major oncology societies such as the American Society of Clinical Oncology on the basis of the concern that it would restrict access.5 Access to and utilization of appropriate breast cancer genetic testing are critical health care issues because of the magnitude of the problem they address. Drohan et al. calculated that only 30 % of more than 35,000 breast cancer patients harboring deleterious BRCA mutations had been so identified. Moreover, the same analysis demonstrated that only 5–6 % of the more than 220,000 as yet unaffected carriers in the U.S. population had been identified and informed.6 Underutilization or underdetection is even more critical when one considers that effective prevention of breast cancer in the expected 50–80 % of such women who will develop breast cancer is widely available, and that nearly all BRCA-based cancers require systemic adjuvant chemotherapy in addition to surgery. To better assess the current practice of breast surgeons in genetic testing ordering, the American Society of Breast Surgeons (ASBrS) conducted a survey of its U.S. members.
with which they did so; (5) whether they obtained C3-generation pedigrees for patients’ family history of cancer; (6) whether they felt confident about the counseling they provided before and after the test; (7) whether they would like the ASBrS to offer educational support and credentialing for BRCA testing; (8) whether insurance approval for testing was easy or burdensome; (9) their practice in referring patients to a genetic counselor; (10) how often patients kept their appointments with genetic counselors; and (11) whether they had ever ordered expanded genetic mutation panels. Responses were accepted for approximately 6 weeks. By the cutoff date, 907 (34.84 %) of 2,603 surveys were completed. Seventeen additional surveys were returned as undeliverable. All 907 responses were deemed suitable for analysis and included.
METHODS
The majority of breast surgeons said that they ordered BRCA testing (Fig. 1). However, 68 % of breast surgeons in academic practice said their patients’ tests were ordered by genetic counselors.
On November 25, 2013, the office of the ASBrS in Columbia, Maryland, sent an anonymous survey (Supplementary Data) via e-mail to its 2603 members (among approximately 3,000 members worldwide) who reside in the United States and who had provided a valid e-mail address as listed in the current member database. The e-mail message contained a link to the questionnaire administered via SurveyMonkey (Palo Alto, CA), a free online survey and questionnaire tool. The content and distribution methods of the questionnaire were reviewed and approved by the ASBrS Research Committee. Followup messages were sent to nonrespondents after 2, 7, and 8 days. The methods were similar to those used for previous ASBrS member surveys, conducted approximately once a year, on various topics.7,8 Survey recipients were asked 11 questions: (1) type of practice; (2) whether they or others tended to order BRCA testing for their patients; (3) under which guidelines they based their decisions to order such tests; (4) the frequency
RESULTS Survey Response and Demographics By January 2, 2014, 907 responses (35 % of members queried) had been received from clinicians throughout the United States working in solo or small group private practices (39 %), hospital-employed breast centers (21 %), academic settings (20 %), large multispecialty groups (18 %), and other settings (2 %). Who Orders the Test
How Often BRCA Tests are Ordered Regarding the frequency of ordering BRCA testing, 45 % said they did so a few times a month; 20 %, several times a week; and 16 %, a few times a year. One fifth (20 %) said they ordered genetic tests rarely or never. When respondents order BRCA testing, a strong majority (61 %) said they based their decision on guidelines from the National Comprehensive Cancer Network (NCCN). Pedigrees of C3 Generations Obtaining a C3-generation pedigree is ‘‘standard’’ for 63 % of respondents (Fig. 2). Others replied that they did so only when considering BRCA testing (15 %) or ‘‘rarely,
ASBrS Genetic Testing Survey
When my patients have BRCA testing it is usually ordered:
Are you confident in your ability to provide appropriate pre-and post-BRCA test counseling?
9.4 % (85)
36.6 % (328)
35.1 % (316)
11.8 % (106)
54.0 % (486)
51.6 % (463)
1.4 % (13)
By me By the medical oncologist By a genetics counselor
By the primary care doctor By someone else
yes, I do so as a standard practice
no
yes, but this is usually done by someone else
FIG. 3 Confidence in genetic counseling skills
FIG. 1 Who orders testing
I obtain a 3 (or more) generation pedigree for my patient’s family history of cancer
14.9 % (132)
Expanded Genetic Mutation Panels More than one third of respondents (39 %) said they had ordered expanded genetic mutation panels; most (61 %) had not. Confidence
20.3 % (179)
63.3 % (559) 1.5 % (13)
More than half of respondents (52 %) reported confidence in their ability to provide appropriate pre- and posttest BRCA test counseling (Fig. 3). More than one third (37 %) said that although they were confident providing such counseling, it was usually done by someone else. Twelve percent of breast surgeons said they lacked sufficient knowledge to perform counseling. Desire for Education
as a standard
rarely, but I can and do when appropriate
only if I am considering BRCA testing
don’t know what this is
Asked whether they would like the ASBrS to offer educational support in genetic testing, most said yes (46 %, ‘‘strongly agree’’; 39 %, ‘‘agree’’; total, 84 %). A minority replied ‘‘disagree’’ (12 %) or ‘‘strongly disagree’’ (4 %).
FIG. 2 Personal practice in obtaining C3-generation pedigree
Ease of Insurance Approval
but I can and do when appropriate’’ (20 %). Therefore, more than 90 % of breast surgeon respondents reported being willing and able to perform 3-generation pedigrees for their patients, a main concern for insurance companies.
Obtaining insurance approval for testing ‘‘is burdensome, but we get it done,’’ according to 58 % of respondents. ‘‘Easy and straightforward’’ characterized the process for 26 %, whereas 9 % considered insurance
P. D. Beitsch, P. W. Whitworth
Do your patients make and keep their genetic counselor appointments?
61.0 % (544) 16.8 % (150)
1.1 % (10) 14.6 % (130)
never
>50%
