If you require access to Kaleida Health (KH) electronic medical records or will be conducting study related procedures within KH, you must complete an appointment package and submit it to Kaleida's Office of Research and Sponsored Projects. This does not apply if you are employed directly by Kaleida Health.
When conducting research at Kaleida you must do a coverage analysis to determine what clinical services are standard care and what services must be billed to the study budget. The coverage analysis includes review of:
You also must review service fees to determine the fair market value of clinical services provided under the protocol. This ensures that the budget covers the costs and fees putting you in compliance with anti-kickback regulations.
Once enrollment begins, we monitor billing claims to ensure that Medicare or other third party payors are not billed for services covered by the study sponsor. All non-standard care services must be pulled from the claim and invoiced separately to the research account. While this manual process is labor intensive and time consuming, it is necessary to ensure that claims are properly billed.
Kaleida's requested $2,000 fee is minimal in light of the extensive work associated with the process. KH charges this fee is in lieu of higher overhead fees which it believes would reduce monetary resources available to the PIs conducting research.
These fees are institution-wide and required for all sponsored studies conducted at KH.
Chief Compliance Officer for Kaleida Health
This can take time so we recommend you submit your documents early in the process.
Effective 1/1/14: Medicare mandated that all clinical trial claims must contain the eight (8) digit clinical trial number issued by the National Library of Medicine for registered clinical trials. This includes Investigational Device Exemption clinical trials.
Find the clinical trial numbers on Clinical Trials.gov.
*Please note, Medicare Advantage Plans will have the same requirements.
The study or trial sponsors and/or the principal investigators are responsible for registering the clinical trial and obtaining the National Clinical Trial number from the Clinical Trials website.
Principal investigators conducting clinical trials at Kaleida Health must provide the number to the Kaleida Health Office of Research & Sponsored Projects to ensure compliance with these billing requirements.
This impacts practice plans as well. Each practice plan physician must provide all necessary information, including the 8-digit clinical trial number, so Kaleida can submit timely claims. You can find the provision in the “Billing and Collection” section of each contract between a university practice plan and Kaleida Health.
Please contact Pam Anderson at email@example.com for all pricing requests.
Anytime a patient is enrolled in a clinical research study, you must complete an encounter form for that visit.