Member Article

On Dec. 21, 2021, the Office of Inspector General (OIG) released a Health & Human Services (HHS) OIG Data Brief on genetic tests provided under Medicare Part B. The goal of the OIG in reviewing this data was “to analyze nationwide trends in genetic tests provided and payments made under Medicare Part B.”[1] As a result of this analysis, the OIG determined that there is a significant risk of overuse and misuse of genetic testing. Healthcare organizations that process genetic tests should conduct audits to ensure that the charges they submit for such tests are appropriate.

The OIG’s study reviewed approximately $3 billion in Medicare payments for 5.1 million genetic tests that were reimbursed from Jan. 1, 2016, to Dec. 31, 2019. The OIG’s analysis found that the average beneficiary received 2.16 genetic tests over the time period of the study. While 2.16 tests may be the average, the OIG also discovered that “of the 2.4 million beneficiaries that received at least one genetic test during that period, more than 67,000 beneficiaries received 10 or more different genetic tests, and more than 3,000 received 20 or more different genetic tests.”^[2]

In fact, during the OIG’s audit period “total Medicare payments to laboratories for genetic tests quadrupled.”^[3] The OIG relied on these data points to draw the conclusion that some portion of the genetic tests that are being ordered are likely excessive and therefore an area of focus for the OIG for potential fraud. The OIG in its analysis discovered three main categories of fraudulent billing: (1) billing for services not provided or performed; (2) unbundling of claims; and (3) blanket ordering.[4] 

The OIG’s Data Brief is a continuation of its efforts to focus on fraud with genetic testing. In September 2019, the OIG issued a fraud alert on genetic testing. The OIG has also been ramping up its enforcement efforts with respect to genetic testing. Due to recent OIG diligence and monitoring of this area, the “OIG and its law enforcement partners charged 35 individuals for their alleged participation in genetic-testing fraud schemes, involving $2.1 billion in losses to the Medicare Program.”[5]

If you or your organization may be impacted by the audit findings or are interested in learning how to comply with the issues raised by the audit, please contact Dinsmore’s health care practice attorneys.

[1] HHS OIG Data Brief (2021, December 21) Trends in Genetic Tests Provided Under Medicare Part B Indicate Areas of Possible Concern https://oig.hhs.gov/oas/reports/region9/92003027.pdf

[2] Id. at 12.

[3] Id. at 16.

[4] Id. at 14.

[5] Id. at 13.