Genetic counseling-including testing and risk assessment-is one of the most rapidly growing areas of oncology and has become the standard of care for patients with a personal and family history of breast, ovary, or colon cancer.
Ellen T. Matloff, MS, CGC
Genetic counseling—including testing and risk assessment—is one of the most rapidly growing areas of oncology and has become the standard of care for patients with a personal and family history of breast, ovary, or colon cancer.
Germline genetic testing is also appropriate for some patients with pancreatic, renal, skin, or thyroid cancers, as well as for those with rare cancer syndromes such as retinoblastoma, von Hippel-Lindau disease and multiple endocrine neoplasias (MEN). The criteria for testing have widened over the years to include not only patients with extensive, multigenerational family histories of early-onset cancer, but much broader patient populations. For example, any woman with invasive epithelial ovarian cancer is now a candidate, as is any patient under the age of 60 years with a triple negative breast cancer. These criteria will continue to broaden as the results of genetic testing are used more widely in surgical-, radiation-, and chemotherapy-decision making. As genetic testing grows, it represents a potential opportunity to provide additional services to an oncology practice’s patients.
Unfortunately, most clinical cancer genetic counselors are located at academic medical centers and it is not uncommon for wait lists at those institutions to range from 4—10 months for non-emergency cases. This supply and demand dilemma presents a unique and forward-thinking opportunity for an oncology practice.
Oncology practices can recruit and employ cancer genetic counselors to work as part of their integrated care team. The average cancer genetic counselor earns between $75—$100K plus benefits, and requires consultation space (vs clinic space) for counseling sessions. Oncology practices with multiple sites could employ a fullor part-time genetic counselor to travel to all sites, or could hire a genetic counselor from an academic institution to provide satellite clinics on a monthly or weekly basis.
Reimbursement for genetic counseling is low, compared with services performed by oncology physicians and nurses. The opportunity for the oncology practice is instead one of niche marketing, increasing catchment areas, and developing an area of unique specialization that will net a new group of patients. For example, it is not uncommon for a patient to travel 1 to 2 hours to see a genetic counselor certified by the American Board of Genetic Counseling. Those patients will then often require high-risk surveillance, chemoprevention and/or prophylactic surgeries. Their family members will also require genetic counseling, testing and long-term services. Unfortunately, it is quite likely that they will someday be diagnosed with cancer, and having an established relationship with an oncology team is certainly of great benefit to those patients and the care team.
Genetic testing is also beginning to be used more frequently in tumor testing. Many hospitals already perform microsatellite instability testing (MSI) or immuno-histochemistry (IHC) on every colorectal tumor and uterine tumors diagnosed in patients less than 60 years of age. Cancer genetic counselors will also prove helpful in interpreting somatic tumor genetic testing and the implications for the patient and family as that field moves forward at breakneck speed. The results of screening tests help to determine which patients may be good candidates for germline genetic testing. Those patients then require a referral for genetic counseling and testing. Widespread testing of tumor blocks is being offered in hopes of personalizing treatment of individual cancers. The panels involved in such testing often include more than 100 genes and the reports can be 10 pages or longer in length. The results of such testing can be critical in determining the correct treatment plan for an individual patient, and can sometimes have implications for that patient’s risk of carrying a germline mutation as well. As the utility of testing grows and the cost drops, genetic testing may become the standard of care for every oncology patient within the next decade.
The promise of genetic testing’s impact on oncology care is great, not only for the individual patient, but for his or her entire family. The complexity of testing is significant, and has increased at least 20 times since the June 2013 Supreme Court decision to ban gene patents, which opened up options for panel testing for patients at risk for hereditary breast and ovarian cancer syndromes.
The rate of result misinterpretation before panel testing was already staggering, with adverse events being reported nationally. Many patients have prophylactic surgeries they do not need or are incorrectly told they are at low-risk to develop cancer because their positive test results were interpreted as normal. At least 30 to 40% of genetic testing is ordered incorrectly. For these reasons, several state insurance companies mandate genetic counseling by a certified genetic counselor before genetic testing. In September 2013, Cigna became the first national insurer to require the same, and it is expected that other insurers will follow with similar policies. In addition to being complex, genetic counseling is time-consuming and associated with great liability for providers not certified in this area. Delegating the elicitation of a four-generation family history, risk assessment, genetic counseling and testing, writing letters of medical necessity, results interpretation, and coordination of testing for other family members to a certified genetic counselor is a time, resource, and moneysaver for the oncology practice, which can then use oncologists for cancer care.
It is currently believed that 5 to 10% of all cancer is hereditary. However, up to 30% of all cancer patients are candidates for genetic counseling and testing. This number will continue to grow as testing criteria expand. And many patients who present for genetic counseling and testing have never had cancer, but are concerned about their future risk to develop the disease.
This is particularly true since the May 2013 public disclosure by Hollywood actress Angelina Jolie that she carries a BRCA1 mutation, and her subsequent decision to have a prophylactic double mastectomy, published in the May 14 Op-Ed column of The New York Times. The program at the Yale Cancer Center experienced a 40% increase in referrals immediately following the Jolie disclosure, and referrals have never returned to baseline.
Oncology practices offering a team approach to high-risk families will attract these healthy patients who have few options in terms of accurate risk assessment, genetic counseling, testing, and long-term follow-up. Packaging all of these services together in an oncology office specializing in high-risk cancer care is a convenient, attractive, rare, and desirable option for patients and their entire families.