A Conversation With Barbara S. Levy, MD, Vice President, Health Policy, American College of Obstetricians and Gynecologists
A woman who receives a diagnosis of breast or ovarian cancer or learns she faces an increased cancer risk because of a relative’s diagnosis may have many conversations with healthcare providers about her options. But before she consults with a genetic counselor, medical oncologist, or surgeon, her decision-making process likely starts with a healthcare provider she already knows: her obstetrician-gynecologist (OB/GYN).
The news about breast cancer may have come after a mammogram her OB/GYN ordered during an annual visit. A diagnosis of ovarian cancer may have arisen after sudden weight gain, bloating, or midmonth bleeding prompted a visit to the OB/GYN. Thus, the perspective of the OB/GYN, who is the primary point of care for many women, matters greatly in any discussion of prevention and treatment of hereditary cancers.
To gain that perspective, Evidence-Based Oncology™ spoke with Barbara S. Levy, MD, vice president of health policy for the American College of Obstetricians and Gynecologists (ACOG), which represents 58,000 OB/GYNs and women’s healthcare professionals. Levy administers ACOG’s Office of Global Women’s Health programs, which focus on improving patient safety and healthcare quality worldwide. She oversees a variety of programs that promote innovation, safety, quality of care, health economics, and health information technology and clinical informatics.
In the reimbursement area, Levy has served on the American Medical Association/Specialty Society Relative Value Scale Update Committee since 1999 and chaired for 2 consecutive terms. The committee is a volunteer panel of physicians and providers that advises CMS on what it costs to perform certain medical services and pay practice expenses.
ACOG’s position statement, the Committee Opinion on Hereditary Cancer Syndromes and Risk Assessment, was first published in June 2015 and reaffirmed in 2017.1 Its chief recommendations are as follows:
1. A hereditary cancer risk assessment should be performed to identify patients and families at risk of developing certain cancers, and OB/GYNs should provide this assessment or other providers and be updated regularly.
2. If a hereditary cancer risk assessment suggests an increased risk of a hereditary cancer syndrome, referral to a cancer genetics specialist is recommended to gather family history, assess risk, and provide counseling, which may lead to genetic testing.
Below is an edited version of a conversation with Levy on ACOG’s positions on risk assessment of hereditary cancers, current trends in genetic testing, healthcare usage, prior authorization, and reimbursement from the perspective of the obstetrician-gynecologist.
At this year’s annual meeting, the National Comprehensive Cancer Network (NCCN) noted that its guidelines for genetic testing do not align with those of the American Society Breast Surgeons (ASBS) and might merit more examination. ASBS called for making testing available to all patients with breast cancer and some without who meet NCCN guidelines.2) Where does ACOG stand?
Levy: We take care of women at the primary point of care, and we are very focused on the general population—we are focused on what is appropriate in shared decision making and on the need to give our members the education and support they need. This means staying up-to-date on options for screening,
what a positive screen might mean, and what the follow-up options are.
There are differences in focus for each organization. If your organization treats breast cancer, you’re focused on capturing every case of breast cancer.
If you’re an OB/GYN, you want that balance for your patient. Overuse of testing can create fear and anxiety, so you want to help your patient understand what is best for her unique circumstances. For a woman with a very high risk [of cancer], that means counseling for her and her family. For women with average and low risk, as their primary care point, we help them understand what their own values are, and people are coming in with vastly different values. Some want to know everything; some are so highly anxious that they can’t know everything—they don’t want to have their anxiety raised by the uncertainty, and they would rather not be tested.
I think it’s a difference in perspective—for us, it’s the marriage of public health with individualized and personalized healthcare. When you are an OB/GYN, you are taking care of a large population with individualized needs. Part of our training is in public health, which is delivering the greatest good for the public. [There’s no value] in a genetic test to uncover a heart condition in someone who is 85, but there is for a genetic test that reveals a high risk of someone developing breast cancer when they are in their 30s, so they can live a totally normal life span. These are the kinds of things our organization would look at somewhat differently than a cancer organization.
EBO: Several years ago, insurers including Cigna called for women to not receive hereditary testing unless they receive guidance from a genetic counselor.3 There has been discussion that there are not enough genetic counselors to meet demand. Where does ACOG stand on this issue?
Levy: ACOG feels pretty strongly that OB/GYNs are well trained to do genetics counseling. We are not PhDs in genetics counseling, and there are compelling circumstances to recommend a referral. But there are not enough genetic counselors for every family and to evaluate every woman for hereditary cancer syndrome. There are some online resources [for counseling via telehealth], but we feel strongly that establishing a relationship with the person is important for shared decision making—some connection between the provider and the patient and her family is important to understanding a patient’s values. That isn’t necessarily going to be possible in the first visit with an online provider. We feel the ob-gyns are well positioned to help patients and families make these kinds of decisions.
EBO: In 2013, following her mother’s death from ovarian cancer, Angelina Jolie revealed that she had received a double mastectomy because she carried a BRCA1 mutation.4 There was a surge of interest in genetic testing, along with reports about overtesting and overutilization of healthcare services. Where do things stand now in ter ms of testing? Is there too much, too little, or the right amount?
Levy: It’s settled down. Whenever there is a celebrity out there, whether it’s an antivaxxer or a person with a hereditary cancer, it makes everybody afraid. People do go in, and they want testing. For people who could afford it, there was overtesting—they would pay for it, even if they didn’t meet the guidelines. If they meet the guidelines and they have coverage, they are screened with the right screening tool.
We are trying to find that sweet spot between too much and too little for the appropriate patient. It bothers us all at ACOG that women without coverage will use over-the-counter [also called direct-to-consumer] genetic testing, thinking that’s a reasonable and adequate test, when the quality is quite different from a medical-grade test. With the BRCA mutations, there are many variants of that gene that the over-thecounter test will miss; the medical-grade version will test for 100 variants. Doing an over-the-counter test is not the same.
EBO: At this year’s meeting of the American Society of Clinical Oncology, findings presented showed that increased coverage has helped close gaps in cancer care.5 What is ACOG’s view? Does the organization see disparities in testing and/or in follow-up after a positive result?
Levy: There are a couple of issues here, involving both access and coverage. If a woman has very simple, barebones coverage, it might cover cancer screening but not the treatment [if cancer is discovered]. There might be a reduction in disparities in screening, but there are problems if follow-up is delayed, [especially] if there are already issues of trust in the medical system—if you come from a place where there’s been experimentation or abuse of the population in particular. [Examples include families affected by the Tuskegee syphilis study6 or those subjected to forced sterilizations by the Eugenics Board of North Carolina.7]
But people in general may find it difficult to trust that their information is safe and that it will not affect their future ability to get insurance to a job. We hear about data breaches in health insurance, so there is a lack of trust among some people about their data. I think access to coverage is a huge issue that helps reduce disparities in shared decision making. At ACOG, we make it clear that our members should be advising women about the hazards of some of this information and how it can be used. We advocate strongly for laws and rules that prevent employers and insurers from using information to restrict people from jobs or restrict coverage. There’s also a lot of policy that has to go behind creating a safety structure for this data.
EBO: What is the situation in states where Medicaid expansion has not taken place?
Levy: Here, we are more focused on obstetrical care. It’s basically the same issue—in states without Medicaid expansion, women are disproportionally affected by lack of coverage. It affects care for mental illness, obstetrical care, substance abuse—it’s across the board—including preventive medicine and public health. We’re trying to make sure there are proper public health interventions, but we are looking at widening disparities between states that have expanded Medicaid and those that have not.
EBO: The trend across guidelines has been toward recommending more genetic testing, not less. However, we continue to hear reports of challenges with reimbursement. What do your members report?
Levy: We hear about the burdens with prior authorization. Getting a test covered is a huge issue for all practices with all the hoops that the payers put in the way to decrease utilization. Cigna has a requirement that all genetic counseling must be done by a certified genetic counselor. With several companies, we’ve been trying to talk to the insurers to show them that among provider groups, the OB/GYN has the right background to counsel people. So, from our perspective, the biggest burden is prior authorization.
When it comes to the cost of the test, the reimbursement goes to the laboratory—it doesn’t go to the OB/GYN. Sometimes there is an administrative burden if the lab does a different test and the patient gets a bill for $3000. We don’t get paid to do the tests; we get paid to do the counseling and the management.
EBO: What are some other challenges you see?
Levy: Cancer screening and genetic screening are complex. There are all kinds of tests, and labs want to take those [mutations] that are well known and add a hundred more to the test. We end up with more mutations of unknown significance. There are games being played on all sides, and patients and providers are kind of stuck in the middle. [In June, the HHS Office of Inspector General issued a consumer fraud alert.8] We recognize that with precision medicine, screening will change for families that have a predisposition to a disease. For colorectal, ovarian, or breast cancer—for those cancers where the hereditary predisposition is well established—it’s easier. But the labs want to expand testing, and keeping them in check is a little bit challenging.
With the changing landscape, our goal at ACOG is help our OB/GYNs and patients get the best possible information for shared decision making. None of
these decisions are straightforward, rubber-stamped kinds of things. We think OB-GYNs can provide the best service to our patients. References
1. Committee opinion no. 634: hereditary cancer syndromes and risk assessment. Obstet Gynecol. 2015;125(6):1538-1543. doi: 10.1097/01. AOG.0000466373.71146.51.
2. Consensus guideline on genetic testing for hereditary breast cancer. American Society of Breast Surgeons website. breastsurgeons.org/docs/statements/Consensus-Guideline-on-Genetic-Testing-for-Hereditary-Breast-Cancer.pdf. Published February 10, 2019. Accessed July 18, 2019.
3. Genetic testing and counseling resources. Cigna website. cigna.com/health-care-providers/resources/genetic-testing-and-counseling-program. Published July 2016. Accessed July 21, 2019.
4. Jolie A. My medical choice. The New York Times. May 14, 2013. nytimes.com/2013/05/14/opinion/my-medical-choice.html. Accessed July 21, 2019.
5. Adamson BJS, Cohen AB, Estevez M, et al. Affordable Care Act (ACA) Medicaid expansion impact on racial disparities in time to cancer treatment. J Clin Oncol. 2019;37(suppl; abstr LBA1). abstracts.asco.org/239/AbstView_239_257961.html.
6. The Tuskegee timeline. CDC website. cdc.gov/tuskegee/timeline.htm.Updated December 22, 2015. Accessed July 21, 2019.
7. Scott L. Wicked silence: the North Carolina forced sterilization program and bioethics. Wake Forest University Center for Bioethics, Health, and Society and the Documentary website. bioethics.wfu.edu/wp-content/uploads/2016/01/WickedSilenceStudentDiscussionGuide.pdf. Published Summer 2015. Accessed July 21, 2019.
8. Fraud alert: genetic testing scam. HHS Office of the Inspector General website. oig.hhs.gov/fraud/consumer-alerts/alerts/geneticscam.asp?utm_source=website&utm_campaign=geneticscam. Published June 3, 2019. Accessed July 21, 2019.