Now is Not the Time for Complacency
The concierge medicine and direct primary care movement represents a genuine and important evolution in how physician services are delivered in the United States. These models, at their best, offer patients more attentive care and physicians more sustainable practices. They are not inherently incompatible with federal fraud and abuse law. But the regulatory environment governing these arrangements is neither simple nor static, and 2026 is not the year for complacency.
Government Enforcement Agencies Care About Concierge Medical Practice
OIG’s April 2026 FAQ updates signal something important about the enforcement agency’s posture: it is watching the growth of alternative practice models, and it is taking deliberate steps to close the interpretive gaps that have been used — sometimes in good faith, sometimes not — to justify arrangements that present real AKS risk. The unambiguous message that FMV is not a safe harbor, and that Stark Law compliance is not AKS protection, is directed at a broad audience. Concierge and DPC practices are squarely within that audience.
Clear Pathways Exist to Assure Compliance
The practical implication is not alarm, but discipline. The Anti-Kickback Statute provides clear pathways for compliant arrangements. The personal services safe harbor can accommodate the vast majority of MSO, employer, and management arrangements that concierge practices routinely enter. The discount safe harbor can protect legitimate vendor pricing concessions. The opt-out framework can insulate direct patient care services from federal billing requirements. These tools work — but they must be used correctly, completely, and with full awareness of the intent analysis that runs beneath every safe harbor evaluation.
Approaching Practice Structure With Vigor and Attention to Details is Advisable
Practices that approach their business relationships with the same rigor they apply to their clinical decision-making — with systematic analysis, documented rationale, and expert consultation when the terrain is uncertain — will find the regulatory landscape navigable. Those that rely on assumptions, analogies to other legal frameworks, or the comforting but legally insufficient assurance that “we’re a cash practice” face unnecessary and avoidable exposure. The field’s regulatory maturity must keep pace with its growth.
■ KEY TAKEAWAYS
- The AKS reaches beyond the practice’s own billing. Even a purely cash-based or DPC practice can face AKS liability through its referral relationships with laboratories, pharmacies, imaging centers, and MSOs that bill federal health care programs — regardless of whether the practice itself submits any federal claims.
- Hybrid concierge practices carry the highest AKS risk. Any physician who both charges a membership retainer and bills Medicare for covered services must ensure that the retainer covers only non-covered enhanced access services and that there is no overlap — operationally or documentarily — between retainer benefits and billed services.
- FMV alone is not a safe harbor (OIG FAQ No. 17, April 2026). Fair market value is a required element of many safe harbors, but it is not itself a defense to AKS liability. Arrangements must satisfy each and every element of an applicable safe harbor — FMV is only one of them.
- Stark Law compliance is not AKS compliance (OIG FAQ No. 4, April 2026). Satisfying a Stark exception does not protect an arrangement from AKS scrutiny. The two statutes have different standards, different purposes, and different enforcement mechanisms, and each requires independent analysis.
- The “one purpose” test applies. Under United States v. Greber, if even one purpose of a payment is to induce or reward referrals of federally reimbursed services, the AKS is implicated — even if the arrangement also has legitimate commercial purposes.
- Compounding pharmacy and lab arrangements are sustained enforcement priorities. OIG has made these categories a multi-year enforcement focus. Any financial relationship between a practice and a compounding pharmacy or reference laboratory requires immediate safe harbor analysis, regardless of the practice’s own billing status.
- Written, advance-set, FMV-based agreements are the baseline — not the finish line. These documentation requirements are necessary conditions for safe harbor protection, not sufficient ones. Intent, commercial reasonableness, and referral nexus must also be independently analyzed.
- Novel arrangements warrant the advisory opinion process. For structurally unique arrangements without a clear safe harbor fit, OIG’s advisory opinion process under 42 C.F.R. § 1008.38 provides binding guidance and remains an underutilized compliance resource for this sector.
