On Dec. 6, 2021, the Office of Inspector General (OIG) issued an advisory opinion (No. 21-19) regarding whether a pharmaceutical manufacturer’s provision of free eye drops to patients who are prescribed one of the manufacturer’s drugs (the product) to mitigate the side effects of the product would be grounds for the imposition of sanctions under civil monetary penalties (CMP) related to the Anti-Kickback Statute and prohibition on beneficiary inducements. The OIG determined the arrangement poses a low risk of fraud and abuse under the federal Anti-Kickback Statute and does not trigger sanctions under the beneficiary Inducements CMP.

Under the proposed arrangement, the requestor, a pharmaceutical manufacturer, manufacturers the FDA-approved product to treat a certain disease [which was redacted from the advisory opinion] in patients who have received at least four prior therapies. The Product causes approximately (70%) of its users to develop certain ocular side effects including keratopathy (changes to the corneal surface). To reduce the risk of keratopathy, the FDA-approved literature for the product (i.e., the product’s label and the medication guide distributed with the product, among other things), recommends that patients use preservative-free lubricant eye drops at least four times per day while undergoing treatment with the product. The eye drops are non-prescription, cost up to $17 per month, and are not typically reimbursed by federal health care programs.