Corporate Compliance

Tip: Plan ahead to determine financial responsibility for research-related injuries

Compliance Monitor, November 2, 2011

Editor’s note: The following tip is an adapted from an article in the November 2011 Strategies for Health Care Compliance.

Clinical research can be complex with respect to billing, especially when a research participant is injured during the course of a trial.

Organizations that fail to review research contracts and plan for the unexpected can find themselves responsible for medical bills and facing new reporting requirements, says David Vulcano, LCSW, MBA, CIP, RAC. Vulcano is an AVP and responsible executive, in the Clinical Services Group at HCA in Nashville.

Organizations should consider using the following checklist for billing associated with research:

Review your contracts. Ensure that the patient infor¬med consent document and your contract with the trial sponsor are consistent.. When these documents aren’t consistent, organizations can literally pay the price, says Vulcano.
Consider reporting requirements. During contract negotiations, determine the effect of contracts on your organization's reporting requirements, says F. Lisa Murtha, Esq., a partner at SNR Denton in Washington, DC. "If sponsors agree to pay for research-related injuries, CMS will consider them a ‘liability plan or carrier' and then the Medicare Secondary Payer rules will be invoked. Then the section 111 reporting requirements kick in," says Murtha.
Identify subjects. Every organization should implement a method whether a patient coming to the facility is a research subject. For example, instructing admissions staff members to ask patients whether they are research study participants is a simple way to verify this information, says Vulcano. Asking this question can help staff determine the source of payment of costs related to care.
Understand malpractice coverage as it pertains to trials. Compliance officers should consider whether malpractice insurance for individual physicians or thefacility will cover research-related injuries, says Vulcano. Malpractice insurance coverage often bars coverage in these situations. Physicians and organizations may be responsible for payment in these cases.
Require investigator certification. Ensure that researchers at your facility are certified. Studies show that investigators certified by the ¬Academy of Pharmaceutical Physicians and ¬Investigators experience fewer protocol deviations and better results during FDA audits by.Certification is a valid predictor of regulatory and protocol compliance and ultimately lowers an organization’s risk. Consider a separate privileging process for clinical investigators. Require that all researchers undergo training that emphasizes good clinical practices to help reduce potential problems, says Vulcano.

Ultimately, proactive planning and clear agreements that specify who pays for what is the best preparation for research-related injuries.

Most Popular