Compliance Focus
BWH, PHS Offers Training, Support for Billing Patients in Trials
Because clinical research often takes place in conjunction with routine clinical care of patients, there is governmental concern that billing clinical and research procedures is handled appropriately and in compliance with legal requirements.
Partners and BWH share a commitment to supporting clinical investigators and ensuring that billing third-party payers for patient care services provided during clinical trials is compliant with Medicare rules and regulations. To advance this effort, Partners and BWH have decided to centralize and expand the support services provided to investigators at BWH and all PHS hospitals.
Effective Jan. 14, every BWH clinical trial is required to have a Medicare coverage analysis as a condition of IRB approval. The Partners Office of Clinical Research Financial Services (CRFS) is responsible for preparing Medicare coverage analyses for all BWH clinical trials, as it is for clinical trials occurring at all Partners facilities. This office will produce a grid in Excel format that lists all items and services associated with each trial and that differentiates what will be covered by the research sponsor and what can be billed to the patient’s insurance. Providing this new centralized service is one phase of a broader plan to improve support to the BWH clinical research community, increase awareness and understanding of clinical trial billing requirements and more effectively manage the clinical trial billing process.
In addition to this new Medicare coverage analysis service, the PHS Clinical Research Office offers a range of pre-award financial planning services for clinical research studies, including budget creation, negotiation with sponsors, financial feasibility assessment of research activities and submission of Medicare B pre-authorization petitions for IDE studies.
To assist in this new process, BWH has scheduled a training session for all principal investigators, coordinators, clinical staff and ancillary staff on how to use the billing grids. The training, entitled “BWH Clinical Trials Billing Fundamentals,” is in Carrie Hall Feb. 28, from 3:30 p.m. to 5 p.m. A make-up session is scheduled for April 30, 3:30 p.m. to 5 p.m. Refreshments will be provided. To register, visit: www.brighamandwomens.org/view/EventDetails.aspx?eventID=40782.
If you need additional billing training or have any questions, contact Sonya Huggins of Research Compliance at 617-732-8337 or shuggins1@partners.org, or Douglas Reichgott, associate director of PHS Clinical Research Financial Services at dreichgott@partners.org or 617-954-9364.