Precision medicine driven by genetic health care is knocking on the door. It offers hope that, sooner than later, we can address health problems like Alzheimer’s disease, cancer, and heart disease that affect the lives of so many Americans.
For many patients, the first step will be genetic testing and counseling by a board-certified genetic counselor. But for 65 million Medicare beneficiaries, genetic counselors’ services are currently behind a locked door. Unlocking it and bringing precision medicine to these Americans will require a simple act of Congress.
As a board-certified genetic counselor with more than 25 years of clinical experience, I have witnessed remarkable advances in genetic health care and how they affect people’s lives. When I started out, I would tell families about inherited forms of cancer or heart disease based on a pattern of family members who were diagnosed or died from those diseases. I could suggest an increased genetic risk based on the family history, but often didn’t have a test to offer to confirm that.
Today, that has changed. Genetic testing can often identify people at higher (and lower) genetic risks for cancer, heart disease, and much more. Now, I can talk to patients about specific health care recommendations or even treatment to get ahead of the disease. We can help families change those histories. That’s the power of precision medicine.
Genetic counselors support patients in understanding their genetic health risks, navigating the rapidly evolving field of genetic testing and interpreting what their test results mean for them and their families. We are critical members of health care teams, helping to deliver the right care at the right time, especially for patients with an increased genetic risk for certain medical conditions. National medical guidelines currently recommend genetic counseling and genetic testing for all people with pancreatic cancer, breast cancer, ovarian cancer and prostate cancer. These guidelines cover a large population; in fact, the National Cancer Institute estimates 669,850 new cases of these cancers this year alone in the U.S.
Despite the fact that medical professionals recognize the need for genetic testing and genetic counseling to help their patients, genetic health care still seems like a far-off proposition for many Americans. Most of the people who stand to benefit from genetic counselor services, such as Medicare beneficiaries, do not have access to them. This is because the Centers for Medicare and Medicare Services does not recognize genetic counselors as providers and does not reimburse for genetic counselor services.
Current Medicare policies limit referrals from other health care providers to genetic counselors due to the “established patient” concept. Most physicians do not work alongside a genetic counselor and are currently prohibited from directly referring their Medicare patients to a genetic counselor. This is because those patients would not be considered an “established patient” in the practice. For non-Medicare patients, physicians can directly refer their patients to a genetic counselor for these specialized services. This inequity and lack of access among Medicare beneficiaries, along with existing health disparities within rural and underserved communities, hinders the promise of precision medicine. It is a lock on the door.
Lack of access to genetic counselor services can result in inappropriate genetic testing, incorrect interpretations of genetic test results, failure to identify people who have increased genetic health risks, and inaccurate risk assessments. Much of this comes down to the explosion of available genetic test options and information about precision medicine. As of November 2022 there were nearly 200,000 genetic tests available globally, with many new tests coming to the U.S. market daily. Health care providers without specialized training in genetics are challenged by rapid growth and increasing pressure to deliver precision medicine to their patients at scale. It is easy to make mistakes, like testing the wrong family member or ordering the wrong genetic test for the patient. But mistakes like these cost significant resources, can raise more questions than they answer, and may also lead to poor outcomes.
Failure to interpret a test correctly can lead to substantial harm. For example, if someone has breast cancer genetic testing, they may receive a result of a “variant of uncertain significance” (VUS). VUS results are not yet medically understood and need to be interpreted with caution, considering the family’s medical history and other factors.
Unfortunately, non-genetics health care providers can misinterpret VUS results as high-risk results and this leads to harmful, irreversible consequences — like a patient having bilateral mastectomy surgeries following a VUS result when they should have had increased breast cancer screening and surveillance (not offered surgery). Mistakes can also lead to the wrong type of treatment plans — and even death.
There is a solution: An act of Congress would make it so that genetic counselors are officially recognized by CMS as providers and, in turn, enable patients access to these specialized services while reimbursing them. A bill in the House of Representatives and its equivalent in the Senate, the Access to Genetic Counselor Services Act, would eliminate onerous referral rules and reimburse genetic counselors for services delivered to Medicare beneficiaries at 85% of physician payment levels. The legislation would also help to address existing health disparities throughout the country. The President’s Cancer Panel was instrumental to informing President Biden’s reignited Cancer Moonshot. The President’s Cancer Panel has recommended legislative changes, such as the ones in this bill, to ensure genetic counselors are reimbursed by CMS.
My colleagues with the National Society of Genetic Counselors and I are working diligently to raise awareness on Capitol Hill about the lack of access to genetic counselor services that millions of Medicare beneficiaries face. In May, we visited the Capitol and met with key members of Congress and their staff. We are grateful for the growing bipartisan and bicameral support for this bill, including from sponsors Sens. John Barrasso (R-Wyo.) and Jon Tester (D-Mont.) and Reps. Adrian Smith (R-Neb.) and Brian Higgins (D-N.Y.).
The Access to Genetic Counselor Services Act would serve as the key to unlocking the door to genetic health care for the 65 million people on Medicare. If passed, the United States would take a vital step in ensuring equity in the advancement and delivery of precision medicine.
Since I joined the genetic counseling field, genetic health care has progressed in ways that make my head spin. As genetic counselors, we’ve gone from discussing the possibility of inherited cancer with no genetic test available, to navigating genetic test options, to talking about test results and personalized care to get ahead of cancer before it starts. It’s the power to help families change their narrative from, “When I get cancer” to, “If I get cancer.”
The promise of precision medicine is astounding, and patients and families need equitable access to that promise. It is time for Congress to lay the foundation for the future and pass legislation that ushers in a new era of health care in America. I encourage patients and health care providers who agree to voice support with their members of Congress.
Deepti Babu, M.S., CGC, is president of the National Society of Genetic Counselors and founder of Integrity Content Consulting. She is a board-certified genetic counselor.