DHPA was among 18 provider and patient advocacy groups that signed onto a letter requesting that the Office of the Inspector General (OIG) issue new guidance indicating that manufacturer copay assistance to federal health program beneficiaries is a violation of the Anti-Kickback Statute when there is a less expensive and equally effective generic or interchangeable biosimilar available.
The OIG has been consistent in its position that drug company copay coupons for brand drugs used in federal health programs constitute a violation of the Anti-Kickback Statute in situations where less expensive and equally effective alternatives exist, but has not directly addressed whether a coupon is an inducement in situations where less expensive and equally effective alternatives do not exist – in other words, in cases where the brand drug is the only available treatment.
In the letter, the groups wrote, “In such cases, the potential for inducement does not exist, therefore, the sound policy rationale underlying the prohibition of these coupons for brands with generic alternatives cannot apply. However, since a regulated industry attempting to stay within legal and regulatory bounds will usually answer open questions with the widest possible interpretation of statute and guidance, the result is that pharmaceutical companies currently will not offer any cost-sharing assistance to Medicare and Medicaid beneficiaries for any medication. In situations where no lower-cost alternative exists, this lack of copay assistance does not result in a patient taking the generic versus the brand. Rather, it can result in a patient not being treated at all to manage their condition(s).”
Click here to read the full letter >>