HHS-OIG Issues Favorable Opinion on Drug Manufacturer’s Free Genetic Testing, Counseling for Patients
Highlights
HHS-OIG recently released Advisory Opinion No. 24-12, a favorable opinion involving a drug manufacturer’s patient support program for individuals who suffer from genetic condition causing chronic kidney stones
The proposed arrangement is consistent with previous HHS-OIG guidance on patient assistance that promotes access to care involving rare health conditions
The HHS-OIG noted several factors that limited the possibility of fraud and abuse, even though the arrangement implicates the Anti-Kickback Statute and the civil monetary penalty provision prohibiting inducements to beneficiaries
The U.S. Department of Health and Human Services’ Office of Inspector General (HHS-OIG) recently released Advisory Opinion No. 24-12, a favorable opinion regarding a drug manufacturer’s program to sponsor genetic testing, related genetic counseling, and disease-state awareness education for certain hereditary conditions that may cause kidney stones. The manufacturer of a drug used to treat chronic kidney stones caused by a rare genetic condition requested the advisory opinion.
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