by Kim Stanger, Holland & Hart LLP
At this time of year, many healthcare professionals want to give gifts to patients, physicians, or other referral sources to show their appreciation, but doing so may violate federal and state fraud and abuse laws. Here are some guidelines to ensure your gift giving does not get you in trouble with the government.
1. Gifts To Referral Sources. The federal Anti-Kickback Statute (“AKS”) prohibits soliciting, offering, giving, or receiving remuneration in exchange for referrals for items or services covered by federal healthcare programs (e.g., Medicare and Medicaid) unless the arrangement fits within a regulatory exception. (42 USC 1320a-7b(b)). AKS violations are felonies, and may result in criminal and civil penalties, False Claims Act liability, and exclusion from Medicare and Medicaid programs. The AKS is violated if one purpose of the remuneration is to induce federal program referrals, including gifts to referring practitioners or program beneficiaries to encourage or reward their business. (OIG Adv. Op. 12-14). Moreover, the AKS applies to both the giver and recipient. The OIG has suggested that “nominal” gifts would not create much AKS risk, but offers no guidance as to what is “nominal”. (65 FR 59441). The AKS does not expressly apply to referrals for private pay business, but the OIG has warned that offering remuneration to obtain private pay referrals may also induce federal program business and thereby violate the AKS. (OIG Adv. Op. 12-06). In addition, offering gifts to induce or reward private pay business may violate state laws, including state laws prohibiting kickbacks, rebates, or fee splitting. In short, you should not give or accept gifts to or from referral sources (especially those referring federal program business) unless the gift is truly nominal, is clearly and completely unrelated to past or future referrals, or is very unlikely to influence referrals.
2. Gifts to Referring Physicians. In addition to the AKS, gifts to referring physicians or their family members may also implicate the Ethics in Patient Referrals Act (“Stark”). Gifts create a financial relationship under Stark; accordingly, Stark would prohibit the physician from referring patients to the giver for certain designated health services payable by Medicare, and would prohibit the giver from billing Medicare for those services, unless a regulatory exception applies. (42 USC 1935nn; 42 CFR 411.353). Stark violations may result in civil penalties, Medicare repayments, and False Claims Act liability. Unlike the AKS, Stark is a strict liability statute: your intent does not matter. Stark does contain a limited exception that allows an entity to give unsolicited non-monetary gifts (not cash or cash equivalents) of up to $300 per calendar year if the gift does not take into account the business generated by the physician and otherwise does not violate the AKS (i.e., not one purpose of the gift is to generate or reward referrals). (42 CFR 411.357(k)). In addition, entities with formal medical staffs may provide one local medical staff appreciation event for the entire medical staff per year. (Id. at 411.357(k)(4)). Any gifts or gratuities provided in connection with the annual appreciation event are subject to the annual $300 aggregate limit. (Id.). In short, unless you are certain that the physician will not refer designated health services to you or you will not bill Medicare for such services, or you fit squarely within a Stark exception, you should not give gifts to referring physicians or their family members. In addition, beware that the AKS or similar state laws may prohibit such gifts even if Stark does not apply.
3. Gifts to Patients. Gifts to federal healthcare program beneficiaries implicate the AKS if they may induce or reward federal program business. In addition, the federal Civil Monetary Penalties Law (“CMP”) prohibits offering or transferring remuneration to Medicare or Medicaid beneficiaries if you know or should know that the remuneration is likely to influence the beneficiary to order or receive items or services payable by federal or state programs from a particular provider unless certain conditions are satisfied. (42 USC 1320a-7a). CMP violations may result in civil penalties and exclusion from federal programs. Unlike the AKS, the OIG has approved nominal gifts if they are not cash or cash equivalents, and they have a retail value of less than $10 individually or an aggregate value of $50 per year per patient. (OIG Bulletin, Offering Gifts and Inducements to Beneficiaries (8/02); 66 FR 24410-11). As with the AKS, the CMP does not apply to private pay patients, although state kickback, rebate or fee splitting statutes may apply. As a practical matter, providers are likely safe if they fit within the $10/$50 limits for gifts to patients.
4. Gifts from Vendors. The AKS may also apply to gifts offered by vendors: it prohibits you from soliciting or receiving such gifts as a reward or in exchange for referring federal program business to the vendors. (See OIG Compliance Program Guidance for Pharmaceutical Manufacturers, 68 FR 23738). As with other gifts between referral sources, you should not accept gifts of more than nominal value if you have referred or may refer federal program business to the vendor. In addition, such gifts may also trigger reporting requirements under the new Sunshine Act regulations. (42 CFR part 403).
Conclusion. Well-intentioned gifts between referral sources may have unintended consequences. Healthcare professionals should ensure that they and their staff comply with the rules cited above along with additional relevant state laws. If you have not done so recently, it may be a good time to review your compliance plan and these guidelines with your staff.
For questions regarding this update, please contact:
Kim C. Stanger
Holland & Hart, 800 W Main Street, Suite 1750, Boise, ID 83702
email: kcstanger@hollandhart.com, phone: 208-383-3913
This publication is designed to provide general information on pertinent legal topics. The statements made are provided for educational purposes only. They do not constitute legal or financial advice nor do they necessarily reflect the views of Holland & Hart LLP or any of its attorneys other than the author. This publication is not intended to create an attorney-client relationship between you and Holland & Hart LLP. Substantive changes in the law subsequent to the date of this publication might affect the analysis or commentary. Similarly, the analysis may differ depending on the jurisdiction or circumstances. If you have specific questions as to the application of the law to your activities, you should seek the advice of your legal counsel.