The Antikickback Statute (AKS) aims to prevent improper financial incentives that might influence healthcare decisions. This law essentially makes it illegal for any entity to knowingly offer, pay, or receive any remuneration to induce referrals of items or services covered by federally funded programs.
Applications of this federal regulation in the pharmaceutical industry often includes two primary concerns:
- Influence on prescribing practices: Financial incentives can sway prescribing practices, leading to decisions that are not in the best interest of patients.
- Relationships with prescribers and patients: Establishing non-compliant relationships with healthcare providers or offering inducements to patients can lead to significant legal penalties.
For pharmacies and pharmaceutical companies, the AKS necessitates a careful review of all business arrangements and promotional activities to help better ensure they do not inadvertently violate federal laws.
What about co-pays as potential AKS violations?
Co-payments are a standard part of the healthcare industry, meant to share the cost of prescription medications between insurance and the patient. However, when pharmaceutical companies or pharmacies offer to cover these co-pays, they might unintentionally breach AKS regulations.
A recent example involves allegations Teva Pharmaceuticals USA and Teva Neuroscience (Teva) worked with co-pay assistance foundations in violation of the AKS. The government gathered evidence to establish that Teva illegally used the foundations to provide co-pay assistance to patients who used an expensive multiple sclerosis drug. The government further alleged the corporation then continued to raise the price of the medication thus increasing the kickback it received after filing for payment with Medicare. When faced with the evidence, Teva agreed to pay more than $400 million to settle the matter. This case provides an example of the financial devastation that can come with this type of error.
For pharmacies and pharmaceutical companies, navigating the requirements of the Antikickback Statute is essential for legal compliance and ethical operation in the healthcare market. By critically assessing interactions with prescribers and the handling of patient co-pays, companies can avoid the severe consequences of non-compliance. Ultimately, adherence to AKS guidelines not only supports lawful business practices but also upholds the quality and integrity of healthcare delivery.
Attorney John Rivas is responsible for this communication.
