Standard of Care Billing More Widespread

TTC estimates that nearly $1.5 billion of US clinical grant spending should be covered as part of standard of care treatment (SOC) by third parties for their patients' participation in clinical trials.

SOC payment in oncology trials has been a common industry practice for a number of years. Sponsor pharmaceutical companies realize that the practice can be extended to other therapeutic areas as well. Additionally, large number of states specifically require that SOC procedures in clinical trials be covered by third party payers.

Clinical sites are accustomed to billing insurance claims for their patients in general. A survey of 512 investigator sites in the United States on their current third party payers billing practices found that two thirds of sites regularly bill third party payers for their patients participating in clinical trials. When broken out by therapeutic area, billing is regularly done for oncology trials (84% of sites), dropping to 30% of sites participating in digestive system trials.

The most mentioned reason by sites for not billing third party payers is simply that the sponsor did not ask them to.

—TTC (for more information, please contact help@ttc-llc.com)