On January 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion 23-15, approving a physician practice consultant’s proposal to offer gift cards to its customers when they recommend the requestor’s services to other physician practices.
Although arrangements for marketing services that do not satisfy a safe harbor ordinarily are suspect under the Anti-Kickback Statute (AKS), OIG concluded the proposed arrangement would not implicate the AKS because the consultant’s services are not themselves payable by federal healthcare programs, even though they may result in increased payment from federal healthcare programs.
The Proposed Arrangement
The requestor provides various consulting services to physician practice clients, including data analytics, workflow optimization, electronic health record (EHR) consulting, and services relating to the Merit-Based Incentive Payment System (MIPS) program. Under the MIPS program, eligible providers must report annually on certain performance measures across different categories and can earn payment adjustments from the Centers for Medicare & Medicaid Services (CMS) based on their performance in those categories. Like the EHR Meaningful Use Program that preceded it, MIPS’s “Promoting Interoperability” component requires providers to demonstrate the meaningful use of certified EHR technology as a portion of their overall score.
The requestor’s MIPS-related consulting services include eligibility screening, annual training, auditing program performance measures, and helping providers submit MIPS performance data. The requestor’s consulting fees do not take into account, and are unrelated to, whether or not a customer earns any MIPS-related payment adjustment, though the requestor acknowledged that its consulting services could generate higher Part B reimbursements for its physician customers.
Under the proposed arrangement, the requestor would offer gift cards to existing physician practice customers who recommend the requestor’s consulting services to prospective customers; practices could earn a $25 gift card for each recommendation and an additional $50 gift card in cases where prospective targets are converted to paying customers.
Notably, the requestor certified to OIG that the services it performs, including its MIPS consulting services, are not payable, in whole or in part, directly or indirectly, by any federal healthcare program. The requestor also certified that it does not recommend to any customer the purchasing, leasing or ordering of any item or service for which payment may be made by a federal healthcare program.
OIG’s Analysis
The requestor’s certifications that it neither provides any federally reimbursable services nor recommends the purchase of any federally reimbursable items or services left little doubt as to the outcome. OIG begins its analysis by stating that the proposal would create three potential streams of remuneration:
- The gift cards the requestor would provide to its customers who refer prospective customers to it.
- The payments from the requestor’s customers to the requestor for its consulting services.
- The increased Medicare payments the requestor’s customers potentially would receive as a result of the requestor’s MIPS consulting services.
Relying on the requestor’s certifications, OIG quickly concludes that none of the remunerative streams would implicate the AKS. The first stream of remuneration would not implicate the AKS, according to OIG, because the gift cards would not be in return for the physician practice customers recommending services that are reimbursable by a federal healthcare program—even though the requestor’s consulting services might result in its customers earning larger MIPS-related payments. Similarly, neither the second nor the third stream of remuneration would implicate the AKS because the requestor certified that it does not recommend to any customer the ordering of any item or service for which payment may be made under a federal healthcare program.
Takeaways
OIG’s conclusion in Advisory Opinion 23-15 is straightforward: because the requestor does not, by its own declaration, furnish federally reimbursable services or recommend the purchase of any federally reimbursable items or services, none of the three identified remuneration streams implicates the AKS. Of course, the result may be different where the link to federal healthcare program payment is stronger.
Interested stakeholders may notice the apparent tension between the favorable outcome in Advisory Opinion 23-15 and recent Department of Justice (DOJ) settlements resolving alleged False Claims Act (FCA) violations by EHR vendors the government claimed violated the AKS by paying referral rewards to providers in exchange for the providers’ recommendations of the vendors’ EHR items and services. DOJ’s position in this line of cases has been that, because providers submit claims for payment to federal healthcare programs under EHR incentive programs, the vendors’ payment of allegedly unlawful remuneration to providers in exchange for referrals caused the submission of false claims in violation of the FCA. For example, in its 2021 Complaint In Intervention against Athenahealth, Inc. (Athena), DOJ argued that Athena “knowingly and willfully offered and paid remuneration in violation of the AKS … to induce the recipients to refer persons for the furnishing or arranging for the furnishing of Athena’s EHR products or to induce the recipients to purchase, lease, order, or arrange for or recommend the purchasing, leasing, or ordering of Athena’s EHR products, for which payment was made in whole or in part under Medicare and Medicaid.” (Emphasis added.)
Stakeholders also must consider OIG’s other guidance regarding the AKS’s reach. In March 2023, OIG issued an FAQ addressing the question of whether arrangements between EHR vendors and their customers implicate the AKS. Concluding that they may, OIG stated:
The [AKS] extends to remuneration to induce, or in return for, the purchasing, leasing, or ordering of, or arranging for or recommending the purchasing, leasing, or ordering of, any good, facility, service, or item reimbursable by a Federal health care program. To the extent the EHR software is either itself reimbursable, in whole or in part, by Federal health care programs or used in the furnishing of items or services reimbursable by a Federal health care program, various financial arrangements could implicate the Federal anti-kickback statute. For example, the statute could be implicated by an arrangement where an EHR vendor pays remuneration to a customer to, for example, market its EHR software to other individuals or entities.
(Emphasis added.) This FAQ response implies that OIG may have reached a different conclusion in Advisory Opinion 23-15 if the requestor’s consulting services, while not paid for directly or indirectly by any federal healthcare program, were used in the furnishing of federally reimbursable items or services.
As always, this advisory opinion is limited to the requestor and to the particular facts and circumstances to which the requestor certified. The requestor’s certification that it does not furnish or recommend any federally reimbursable items or services appears to have been central to OIG’s favorable conclusion in this opinion. It is unclear under what circumstances, if any, the government might assert that consulting services that may generate higher federal healthcare program reimbursements (or that are used in the submission of claims to federal healthcare programs for payment) implicate the AKS. Ultimately, parties to such arrangements should carefully review all available guidance before implementing any program or practice to reward referral, marketing, lead generation or conversion activities.
If you have any questions about this advisory opinion, please contact the authors.