Congress enacted the Eliminating Kickbacks in Recovery Act (EKRA) in 2018 as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018, PL 115-271 (October 24, 2018). This act prohibits receiving or paying any remuneration “directly or indirectly, overtly or covertly, in cash or kind” for referrals to a laboratory, recovery home or clinical treatment facility. EKRA applies to all payors and not just those federally funded ones such as Medicare and Medicaid. It applies to services covered by any health care benefit program affecting interstate commerce. There are a few exceptions defined within the statute such as discounts in applicable drugs for applicable beneficiaries. Additionally, there are exceptions related to payments made under a contractual agreement that was established before October 24, 2018 and does not involve an increase in payment as a result of any solicitation of referrals. Finally, EKRA does not apply if the remuneration is paid by or on behalf of an individual who is an applicable beneficiary who is being referred for services under applicable law.

EKRA exempts certain payments from the statute’s general prohibition on kickback arrangements. Payments made pursuant to a contractual agreement that was established before October 24, 2018 and does not involve an increase in payment as a result of any solicitation of referrals are exempt. Additionally, payments made by or on behalf of an individual who is an applicable beneficiary referred for services under applicable law are also exempt from EKRA regulations.

Under EKRA, benefits and discounts related to drugs for applicable beneficiaries are exempt from the statute’s general prohibition on kickback arrangements. These exemptions include:

• Discounts given to individual patients or their representatives, for covered drugs obtained at an entity other than a pharmacy.
• Discounts provided by pharmacies for covered drugs, provided that pharmacies retain control over drug pricing, patient eligibility determination, and billing information associated with the discount.
• Discounts related to free samples of any covered drug distributed by a manufacturer or its authorized representative, provided that certain conditions are met regarding distribution and patient fees.
• Rebates provided directly or indirectly by a manufacturer to an entity other than a pharmacy due to price concessions.
• Patient assistance programs established by manufacturers designed to help individuals who lack the resources to pay for covered items or services.
• Remuneration deemed necessary under applicable law between pharmacists and manufacturers not included in published price lists used as payment bases for calculating reimbursement rates.

Rebates provided directly or indirectly by a manufacturer to an entity other than a pharmacy when they are due to price concessions is common exemption used. As an example, rebates may be given based on volume discounts or other agreements between manufacturers and entities that provide drugs or services reimbursed by Federal health care programs. Reimbursement rates calculated using published price lists do not include these types of rebates.