Define each person’s role before launching
Who evaluates the patient? Who makes the treatment decision? Who orders, stores, sells, and administers the product? Who receives the fee? Put the real workflow on paper. Counsel should compare it with the law of the state where the patient receives care, each professional’s license, and the contracts between the practice and any medical partner.
A referral arrangement needs its own review
Paying for marketing, sharing office space, employing professionals, and receiving a percentage of treatment revenue are different arrangements. State ownership and fee-splitting rules, and federal referral restrictions where applicable, require fact-specific assessment. Calling a payment a consulting fee does not settle its legal character. Have counsel review the actual services and compensation before relying on a template agreement.
Civil and criminal issues are not interchangeable
A patient may allege that the office overstated benefits, failed to explain material risks, or provided care outside an authorized role. A board complaint is a separate process and is not proof of a criminal offense. Section 333 provides criminal penalties for prohibited drug-law conduct, including enhanced penalties for certain repeat offenses or intent to defraud or mislead. [3]
How an attorney can help protect the practice
Counsel can assess whether the proposed service should proceed, change, or stop; review professional roles and compensation; coordinate a response to a board; and evaluate patient complaints or insurance obligations. Legal review should occur before adding the offering to a treatment menu. It cannot replace the medical judgment or licensing authority of the treating professional.