One of the most exciting advances in healthcare is the growing field of personalized medicine. Personalized medicine involves identifying genetic and genomic information that helps predict a person’s susceptibility to developing a particular disease, the possible course of that disease, and the disease’s response to different treatments.1
Personalized medicine made it possible for Sarah Kelsey, a healthy 41-year-old woman living in Virginia, to take control of her future.
Sarah’s mother passed away from metastatic breast cancer in her early forties, and after several other maternal relatives were given the same devastating diagnosis, Sarah ultimately decided to have the genetic test that would determine whether her genetic makeup included the BRCA mutation—an indicator of a strong likelihood of developing breast or ovarian cancer during one’s lifetime.
A strong family history of breast cancer was enough for Sarah’s insurer to cover the cost of genetic testing. After undergoing the genetic test, Sarah learned that she did carry the BRCA mutation. She worked with her care team to evaluate her options, which included vigilance, surgery, and specifically tailored drug therapy. The oncology team treating Sarah recommended close monitoring, which would consist of frequent clinical exams and magnetic resonance imaging (MRI), which is more accurate than mammography when it comes to detecting early-stage breast cancers in young women, who typically have dense breast tissue. This seemed to be a reasonable treatment plan given the positive test results for the BRCA mutation and considering that Sarah was not yet ready to undergo preventive surgery.
When preparing to follow the prescribed testing, Sarah learned that her insurer would not cover the cost of repeat, nondiagnostic MRIs. Although she and her husband paid for the MRIs themselves for a while, the compounding expense was a factor in Sarah’s ultimate decision to switch gears and undergo preventive surgery.
Limited Access to Personalized Medicine Affects Women
Although Sarah’s family medical history qualified her to receive BRCA testing through her insurer, many women still experience difficulty in getting coverage of not only MRIs but also BRCA testing. This is despite the fact that BRCA testing is currently the only preventive genetic test endorsed by the US Preventive Services Task Force. The Patient Protection and Affordable Care Act (ACA) requires most plans to cover the cost of BRCA testing if a woman’s family history indicates a higher-than-average risk for a BRCA mutation.
Many women also have difficulty accessing another area of personalized medicine: treatments that are tailored to their unique genetic makeup. Pharmacogenetics, which is the study of how a patient’s genes affect whether a treatment is likely to be effective, what the appropriate dose should be, and whether the patient is likely to experience a serious side effect,2 can assist in identifying the most appropriate treatment without requiring a woman to undergo ineffective treatment or endure unnecessary adverse effects. Theoretically, the ACA also requires most plans to cover pharmacogenetic testing because the ACA mandates coverage of laboratory services that allow doctors to determine whether a medication is effective.
Insurers skirt these requirements, however, by exploiting loopholes in the ACA. They use burdensome cost containment policies, such as prior authorization, to make it harder to access innovative treatments and technologies.3
Prior authorization is a list of criteria that must be met before the technology will be considered medically necessary for disease diagnosis or treatment. For example, insurers have instituted prior-authorization policies that require individuals see a genetic counselor before qualifying for BRCA testing, even though a patient’s physician is fully capable of assessing whether the testing is medically necessary simply by determining that breast cancer runs in the family.4 Not only does this requirement result in additional out-of-pocket costs for the patient to see a genetic counselor but it may be particularly hard for women in remote areas to find a genetic counselor at all. These women must either travel long distances to find a counselor or forgo the testing altogether because they do not meet the prior-authorization requirement.
States are beginning to enact laws that correct some access problems, but most of these laws do not reach far enough. They often do not include any protections for testing technology. Far too many women find themselves in the same position as Sarah: in need of pharmacogenetic or diagnostic testing but ill equipped to implement their physician’s recommendations and the medical community’s widely accepted standard of care.
Take Empowering Action
So what can you do if your insurer denies access to the testing and treatments recommended by your physician and accepted as the established standard of care?
The first step is to appeal the decision. All insurers have appeals processes, and patients often win if they appeal a denied health claim. Work with your physician, who can send a letter on your behalf; and, if you need help with the process, contact a patient advocacy group, such as the Patient Advocate Foundation, that offers a variety of resources to help patients access care.
If you have exhausted the appeals process and still cannot access testing, file a complaint for unfair business practices with the state attorney general or insurance commissioner. While personalized medicine can offer lifesaving preventive and treatment approaches, it saves no lives if it cannot be accessed.
1. Personalized Medicine. U.S. News and World Report. January 20, 2011. Available at: http:// health.usnews.com/health-conditions/cancer/personalized-medicine/overview. Accessed July 24, 2016.
2. Drug-Gene Testing. Mayo Clinic website. Available at: http://mayoresearch.mayo.edu/center-for-individualized-medicine/drug-gene-testing.asp. Accessed July 24, 2016.
3. Hresko A, Haga SB. Insurance coverage policies for personalized medicine. Journal of Personalized Medicine. 2012;2(4):201-16. doi: 10.3390/ jpm2040201.
4. Maas A, UHC Fine-Tunes Policy on Genetic Counseling Prior to BRCA Test. AIS Health website. January 29, 2016. Available at: http:// aishealth.com/archive/nspn0116-04. Accessed July 24, 2016.
Stacey L. Worthy, Esq., is the executive director at Alliance for the Adoption of Innovations in Medicine (Aimed Alliance), a nonprofit organization that improves healthcare in the United States by expanding access to evidence-based treatments and technologies. In this role, she provides unique legal insight through research and analysis of laws, regulations, and legislation; develops policy; manages advocacy initiatives; and oversees coalition-building efforts of allied organizations focused on advancing the common goal of improving provider-driven, patient-centered care. She is also a partner at DCBA Law & Policy in Washington, DC.