The federal Anti-Kickback Statute prohibits the exchange of anything of value to induce or reward the referral of federal health care program business. Business processes that are perfectly legitimate in other industries, like entertaining clients, or providing gifts to prospects, can be tricky in the medical device industry. Identifying the activities hold the potential to implicate the Anti-Kickback Statute is key to reducing risk across a medical device company.
Here are five areas to evaluate for risk:
Device Loaners/Evaluation Units
Device loaners and evaluation units are big risks. Be sure to provide only as many units as needed for evaluation, and for no longer than is necessary for the evaluation. If the loaner is provided to temporarily replace a broken unit, make sure the loan period does not continue past the time necessary to complete the service work.
Pricing discounts require a level of transparency on the part of the seller and the buyer. Purchase agreements must clearly disclose the discount, and purchasers should be advised in writing that they too need to disclose the discount when they submit information to federal healthcare programs for reimbursement.
Gifts, Meals, Travel
Providing meals, gifts, travel and hospitality to an individual who is in a position to purchase, or recommend the use of a product, is risky. Gifts that do not have an educational benefit for the recipient or patients are particularly problematic.
When a gift is provided, the value should be nominal and cash or cash equivalents are never appropriate. Avoid lavish meals, and make sure meals occur in locations that are conducive to holding a business, educational, or scientific discussion. Finally, do not provide lavish travel or hospitality for company training or meetings.
Remember to establish the objectives for consulting engagements with healthcare professionals (HCPs) prior to the start of the business relationship and only use as many consultants as needed to achieve the objectives. Timelines need to be included in the agreement and the consultants must be compensated at fair market value. The consulting relationship needs to be disclosed during the program.
Grants and Donations
Establish processes to objectively evaluate requests for grants and donations. Support should not be awarded to induce or reward the purchase or recommendation of product. Support of educational grants should not be contingent on the ability to select faculty or determine content of the program.
Medical Device Anti-Kickback Training
Our Compliance Foundations medical device eLearning modules cover critical topics such as the Anti-Kickback Statute, interactions with healthcare professionals, transparency, and speaker programs. Course titles include The AdvaMed Code; Global Anticorruption Laws; Medical Device Compliance Overview; and On-label Promotion. To see a demo and learn more, please contact Dan O’Connor at firstname.lastname@example.org or 609-483-6875.
Thanks for reading!
Lauren Barnett, Senior Compliance Specialist