Genetics in Healthcare and Compliance Risks

The Future and Hope of Genetics in Healthcare

Genetics is the future of medicine and healthcare. No longer will the healthcare system just treat hypertension, diabetes, or cancer; instead, it will identify genetic markers on a tumor or examine the genetic make-up of patients with certain conditions to anticipate how an individual will respond to medications and treatments. Sometimes this is also referred to as personalized medicine. Still, the foundation of this approach is a genetic evaluation of individuals and how their genetic makeup may affect how they respond to a particular medication or treatment modality. The promise of genetics is also a future with more predictability and prevention of diseases and genetic predispositions before the patient suffers severe consequences. For example, think of genes that predispose a woman to breast cancer. Knowing this genetic predisposition early could lead to more aggressive prevention and/or monitoring strategy. The hope that genetic medicine brings to the table is immense to so many.

However, all these promises are not yet fulfilled even though millions of people have genetic testing performed. And unfortunately, some are taking advantage of the opportunity to either order medically unnecessary genetic testing or participate in fraudulent schemes.

Medically Unnecessary Genetic Tests

For example, the U.S. Department of Justice recently announced a settlement involving a Florida man who pleaded guilty to a $6.9 million conspiracy to defraud Medicare by paying kickbacks and bribes to obtain doctors’ orders for medically unnecessary lab tests including genetic tests, that were then billed to Medicare. The defendant, in this case, exploited the COVID-19 pandemic by bundling COVID-19 testing with other forms of testing that patients did not need, including genetic testing. Some genetic tests were for cardiovascular diseases, cancer, diabetes, obesity, Parkinson’s, Alzheimer’s, and dementia. Whereas an internal whistleblower prompts most healthcare cases like this, there was no mention of this in the press release. Instead, this case was brought through proactive government efforts, including efforts from the recently created COVID-19 Fraud Enforcement Task Force.

HHS OIG Fraud Alert

Genetic testing is not just a concern associated with COVID-19 testing. HHS OIG has published a Fraud Alert concerning genetic testing scams. The Fraud Alert warns the public that “scammers are offering Medicare beneficiaries “free” screenings or cheek swabs for genetic testing to obtain their Medicare information for identity theft or fraudulent billing purposes. Fraudsters are targeting beneficiaries through telemarketing calls, booths at public events, health fairs, and door-to-door visits.”

The Fraud Alert continues to warn beneficiaries who agree to genetic testing or verify personal or Medicare information may receive a cheek swab, an in-person screening, or a testing kit in the mail, even if it is not ordered by a physician or medically necessary.

The Fraud Alert is not the only published information from the OIG about genetic testing risks. In December 2021, the OIG published a Data Brief titled, “Trends in Genetic Tests Provided Under Medicare Part B Indicate Areas of Possible Concern.”

The entire report is worth the read, especially if your organization is involved in ordering or performing genetic tests in any way. But here are some highlights of the data brief which focused on calendar years 2016-2019:

• • Medicare payments for genetic tests quadrupled.
  • The number of genetic-testing procedure codes Medicare-covered increased by 161 percent. The number of genetic tests Medicare paid for increased by 230 percent.
  • The average amount Medicare paid per beneficiary who received at least one genetic test increased by 75 percent. The average number of genetic tests paid per beneficiary increased by 43 percent.
  • The number of laboratories that received more than $1 million in Medicare payments per year for genetic tests almost tripled. The number of providers ordering genetic tests for beneficiaries more than doubled.

The OIG concluded their Data Brief by stating, “Although there are legitimate reasons that genetic testing has increased, the increases indicate areas of possible concern, such as excessive testing and fraud, which may negatively affect beneficiaries (e.g., the beneficiary may be responsible for the cost of genetic tests if Medicare denies claims and a signed ABN is on file)…Oversight by CMS and the MACs is critical to prevent fraud, waste, and abuse related to genetic testing and protect Medicare beneficiaries.”

Genetics: Opportunities For Improvement and Risk

The opportunities for improving the practice of medicine through genetic testing and personalized medicine are great, and we all should be optimistic about this genetic movement. However, there is undoubtedly a compliance risk associated with genetic testing when tests are not ordered or performed according to the law and regulations, especially the underlying principles of conscientious physician ordering and medical necessity.

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