New ethical guidance may be useful toward establishing precision medicine services in hospitals and community practices
Aiming to help healthcare leaders be more aware of ethical practices in precision medicine, the American College of Physicians (ACP) has released a position paper outlining four key statements on the ethics of precision medicine testing. This paper was coincidentally released less than one week after the US Department of Justice (DOJ) announced dozens of charges for a $1.2 billion healthcare fraud scheme involving precision medicine. These charges will be the first time that cardiovascular genetic testing fraud has been prosecuted in the US, according to the DOJ.
Published in the Annals of Internal Medicine, the ACP’s position paper on precision medicine ethics provides healthcare organizations and providers clear direction on how to consider the ethical implications of precision medicine testing.
The ACP emphasizes that the purpose of this paper is primarily to support physicians, but the positions explained could be applied to a variety of clinicians or organizations. “This American College of Physicians position paper aims to inform ethical decision making for the integration of precision medicine and genetic testing into clinical care,” the ACP explains. “Addressing the challenges of precision medicine and genetic testing will guide ethical and responsible implementation to improve health outcomes.”
ACP Takes Four Key Positions in New Precision Medicine Paper
Precision medicine is based on knowledge of a person’s genetics, lifestyle, and environment, and encompasses a wide spectrum of uses of genetic information. In practice, precision medicine approaches can include predictive risk testing, risk assessment, diagnostic testing, pharmacogenomics, molecular profiling of tumors, population screening, and direct-to-consumer genetic testing. With this in mind, the ACP has taken four key positions to guide doctors forward:
- “Genetic testing, like any testing, should be guided by the best interests of the patient, scientific evidence, and ethical standards. The physician’s ethical responsibility to practice high-value care requires consideration of the benefits and harms of any test based on the scientific evidence.”
- “Physicians should prepare to engage with patients in discussions about the opportunities and ethical challenges of genetic testing and precision medicine.”
- “Patients will need assistance from their physicians to understand the risks, benefits, and uncertainty of direct-to-consumer genetic medical testing.”
- “Physicians, health care systems, and others with access to patient data should safeguard the privacy, confidentiality, and security of patient information, including genomic information.”
Two of these positions address the knowledge gap that exists in precision medicine treatments and tests. Many patients have not heard about precision medicine testing and treatments, or they do not fully understand the clinical implications of genetic testing.
The ACP takes the position that educating patients about this topic is primarily the responsibility of the physician. This suggests that healthcare organizations adopting precision medicine should ensure that their physicians have a strong foundational knowledge of precision medicine tests and treatments.
The ACP’s position paper also touches on the ethics of performing genetic testing that identifies diseases for which there are no treatments. While the ACP does not make a specific recommendation on how to approach this situation, it does acknowledge it as an ethically complex subject that should be further explored.
DOJ Hunting for Fraudulent Genetic Testing
The ACP’s position paper came within days of the announcement of a substantial breach in precision medicine ethics. On July 20, 2022, the Department of Justice announced charges for $1.2 billion in healthcare fraud. Much of this fraud centered around fraudulent cardiovascular genetic tests ordered using telehealth.
While substantial attention was given to the abuse of telehealth technology, the DOJ also pointed out that these charges are the first time that fraudulent cardiovascular genetic testing has been prosecuted in the US.
According to a DOJ press release, the scheme centered around the use of telehealth to order unnecessary cardiovascular and cancer genetic tests, as well as durable medical equipment. Medicare was then billed for the unnecessary tests, leading to a financial windfall for those involved. In addition, the profits from this scheme were used to buy multiple properties, a yacht, a Tesla, and other vehicles.
“Today’s enforcement action highlights our dedication to fighting health care fraud and investigating individuals who target Medicare beneficiaries and steal from taxpayers for personal gain,” said Christi A. Grimm, Inspector General of the US Department of Health and Human Services (HHS), in a statement. “HHS-OIG is proud to work alongside our law enforcement partners to disrupt fraud schemes that use the guise of telehealth to expand the reach of kickback schemes designed to cheat federally funded health care programs.”
Healthcare leaders should be aware that not only are there ethical considerations for responsibly using precision medicine tests, but there is new focus by the DOJ on reducing unnecessary, fraudulent genetic testing. While precision medicine provides an amazing tool for improving health, using this tool responsibly is essential to providing ethical treatment.