by Kim Stanger

Unless structured properly, a hospital’s financial relationship with referring physicians or other providers may violate the federal Ethics in Patient Referrals Act (“Stark”) and Anti-Kickback Statute (“AKS”), resulting in civil and criminal fines, penalties, and repayments. Under Stark, if a hospital has a financial relationship with a physician, the physician may not refer patients to the hospital for certain designated health services¹ payable by Medicare or Medicaid unless the arrangement fits within a regulatory safe harbor. (42 USC § 1395dd; 42 CFR § 411.353). The AKS generally prohibits knowingly offering, paying, soliciting or receiving remuneration to induce referrals for items or services payable by federal healthcare programs unless the arrangement fits within a regulatory safe harbor. (42 USC § 1320a-7b(b); 42 CFR § 1001.952). Below are some of the top compliance concerns arising from relationships with referring providers:

1. No Written Agreement. Except for employment arrangements, Stark and the AKS generally require that financial arrangements are documented in writing and signed by the parties, including arrangements involving the payment for services, sale or lease of space or equipment, recruitment subsidies, etc. (See, e.g., 42 CFR §§ 411.357(a), (b), (d), (e), (l), (p), (y), and 1001.952(b)-(d)). CMS has confirmed that a single formal contract is not necessarily required; instead, “a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement…” (80 FR 71315).