Advances in DNA testing have thrust providers of precision medicine into often exciting, but sometimes unchartered waters.  There’s the thrill of unlocking the mysteries of a rare illnesses through genetic testing, and the satisfaction of identifying new individualized patient therapies. And, with the promise of precision medicine comes the need to understand new legal and ethical concerns.

Legal issues in precision medicine is one of many topics Mayo Clinic’s Center for Individualized Medicine has explored at its Individualizing Medicine Conference. Here are takeaways on four legal issues providers of precision medicine might want to keep in mind:

1. Question of discrimination

One of the first questions patients often ask when considering genetic testing is, ‘will my DNA test results come back to haunt me when I go shopping for insurance?’

The answer lies within the Genetic Information Nondiscrimination Act (GINA). Passed in 2008, GINA bars health insurance companies from denying patients coverage or charging higher rates based on genetic findings. The law also makes it illegal for employers to discriminate against patients whose genetic test results show the potential to develop serious illnesses or rare diseases.

However, the law does not extend the same protections to life, disability or long-term care insurance. There is a potential they could see genetic test results that have been entered into a patient’s medical records.

2. Beware of waiving lab fees

Sharon Zehe, J.D.

Genetic testing often involves out-of-pocket costs for patients. Insurance sometimes covers the testing fees, but patients may be responsible for deductibles and copays. Other times, insurance doesn’t cover it at all, and patients must pay the entire bill. In the competitive world of health care, it can be tempting for providers to waive or discount out-of-pocket fees in order to attract patients.

But, it’s provider beware. Doing so may be a violation of the federal fraud and abuse regulations and state fraud laws. It may also put patients in a situation that violates member agreements relating to copays and deductibles. UnitedHealthcare recently sent a notice to laboratories notifying them claims would be denied if the lab engaged in a fee waiver program in violation of their agreement with members.

“Here at Mayo, we advise providers not to send tests to labs that offer fee waiver programs or cap a patient’s out of pocket costs below what they would otherwise be required to pay under their plans. We recognize that limiting the financial impact to a patient is a good thing, but unfortunately the legal risks are too significant. Some commercial payers have sued laboratories over fee waiver programs,” says Sharon Zehe, J.D., an attorney for Department of Laboratory Medicine and Pathology at Mayo Clinic and Mayo Medical Laboratories.

3. Addressing privacy

Providers often find themselves in a position of allaying patient concerns about privacy. All genetic test results are considered protected health information under HIPAA laws that guard privacy. That means the information cannot be shared with anyone (except in limited situations) without the consent of the patient.

Privacy issues also can put providers in an ethical dilemma, because the provider may have information from a patient that could help a family member. What if test results show a patient's family members are at risk for a genetic disease, especially if the disease could be terminal without early intervention? Sometimes test results reveal a paternity issue. Should providers let patients know their father is not who they think? Unless a patient has signed a consent form to share results with family or friends, a provider cannot reveal these issues.

“It’s a sticky issue. For instance, in order to get an accurate picture of a child’s genetic makeup, we sometimes need testing from both parents. If we find we don’t have test results from the child’s true biological father, we cannot provide accurate results. It creates a dilemma of how to proceed,” says Zehe.

4. Understanding liability for genetic results that science does not yet understand

One of the key challenges with DNA testing is the fact that it returns a large amount of data on genetic variants that scientists and physicians do no yet understand. These are called variants of unknown significance. It raises the question: how do providers handle new discoveries of what these variants mean? Is there an obligation to go back and provide information about previously unknown variants? Can the provider be held liable for not contacting patients to let them know there is new information that could impact their health?

That is the crux of the issue in the Williams v. Quest /Athena lawsuit. In this case, a child’s genetic variants were not clearly understood at the time the test results came back. Later the variant was linked to a disease known as Dravet Syndrome. The child died without having the proper diagnosis. The mother sued, claiming Athena, the laboratory, should have known about the discoveries linked to Dravet Syndrome — discoveries that she claimed could have led to life saving treatments for her child.

“We are watching the legal rulings closely. It will be important to understand if the court holds it is a lab’s responsibility to contact providers or patients when information about undefined genetic variants becomes available, and if so, how far back should a laboratory go?” says Zehe.

Legal and ethical issues related to individualized patient care will undoubtedly be defined over time, whether that’s through court rulings or new laws. As precision medicine becomes routine, providers will be able to follow unfolding guidelines to better understand how to safely, effectively and legally act in their patients’ best interests.

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Tags: #DNA sequencing tests, #Genetic Information Nondiscrimination Act, #genetic testing fees, #legal issues, #Patient privacy, #Sharon Zehe, center for individualized medicine, Genetic Testing, mayo clinic, Precision Medicine, Uncategorized