Medicare Compliance & Reimbursement

Question: What should a physician practice consider when providing free samples of a medication in conjunction with an office visit procedure? The nurse administers the medication as part of the care during the visit.

Answer: For starters, the practice should not bill the patient or any payer for the medication, advises attorney Chris DeMeo, in Houston, Texas. And "don't use the samples as a way to induce patients to the practice." For example, you wouldn't advertise or promote the availability of the medication even informally through word of mouth, he adds.

Also consider implementing a "one and done" policy where if a patient wants to receive the medication, the physician gives him a prescription for it, DeMeo advises. "The physician should advise the patient of this plan at the time the sample is provided and document that in the medical record."

When the patient returns for follow-up, assess and document his reaction to the medication, he instructs. "If the reaction is negative, note that the product will not be used again. If the reaction is positive, note the efficacy and patient choice as reasons for the prescription."

DeMeo notes that the HHS Office of Inspector General has "instructed that free items or services provided to established patients are likely to be considered inducements." Thus, the practice should consider not offering the medication to established patients. And consider taking other steps to "eliminate even the appearance of an inducement." For example, "advise the patient there will be no more free sampleson future visits."

Also: "Consider establishing a documentation system that proves proper use of the samples. For example, the practice could keep a log of items received and how they were distributed." DeMeo says. Identify the sample in detail, he advises, "but be careful with the receiving patient's protected health information since unauthorized persons may have access to the log."

Important: "Do not return the favor to the drug company by utilizing its products when not medically necessary or to the exclusion of comparable alternatives," DeMeo counsels.