There is always an area of legal caution and concern when biopharma pays for services, like genetic testing that is the gateway to a particular drug.
On December 17, 2024, OIG released an Advisory Opinion favorable to allow a biopharma to pay for genetics, and genetic counseling, related to its drug for a rare genetic cause of oxalate overproduction.
Find the report here:
https://oig.hhs.gov/documents/advisory-opinions/10117/AO-24-12.pdf
The OIG finds that the genetic services DO provide remuneration under the Anti Kickback Statute (AKS) and Beneficiary Inducement Civil Monetary Penalties (BI-CMP). However, the OIG reasons that the risk of over use or improper use is very low and it would not seek penalties.
The case mentions that the lab is Blueprint Genetics, a subsidiary of Quest. The case carefully redacts the name of the pharma and drug; the only rare genetic oxalate drug I know of is Oxlumo (lumasiran), from Alnylam (for primary hyperoxaluria Type 1 PH1). On approving Oxlumo, FDA remarked, "PH1 affects an estimated one to three individuals per million in North America and Europe." The drug is an RNAi therapeutic.
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Oxlumo was approved in 2020 and got a label expansion in 2022 for plasma oxalate reduction in CKD patients.
