Practice Management Alert
Check Payer Rules Before Launching Clinical Studies
Question: Our practice is interested in participating in a clinical research study. What billing and compliance issues should we consider before we decide for sure? Answer: Participating in a clinical research study can be a great way for practices to use new drugs or devices to treat patients. However, both federal regulators and payers are closely scrutinizing such studies, so you need to plan your participation carefully if you want to avoid audits or fraud and abuse allegations.
Oklahoma Subscriber
The first question you should consider is: What services can we appropriately bill payers and patients for? Your practice will probably collect a fee from the organization running the study, but it is likely that patients must visit regularly so doctors can monitor how well they're doing on the new drug or device. You need to check your payers' rules to know what items and services are billable.
Medicare and most commercial payers usually allow you to bill for services you would ordinarily provide to the patient - whether or not he is participating in the study. For example, if a patient participating in the study has a condition that necessitates regular evaluation and management visits anyway, it is likely that you could still submit claims for those visits.
Your second concern is the fee the physicians are collecting from the organization running the study. You must be sure that fee is fair market value for data collection, analysis or other services the physicians provide - not just a kickback from a drug or device company.
Finally, you need to make sure your participation in the study will not cause you inadvertently to violate the HIPAA privacy regulation. For example, you must make certain that the company involved in the study isn't getting access to medical records without the patient's written authorization. You should also inform yourself about the study sponsor's marketing practices so you can make sure it is not using patient mailing addresses and other information you provide for solicitations that would violate HIPAA.
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