In order to fulfill our duties as a non-profit and appropriately support research efforts, UCHealth has determined that all industry sponsored research studies should be charged a fee to recover the cost of Medicare Coverage Analysis (MCA) performed by UCHealth Research Administration.

Medicare covers the routine costs (i.e., tests, procedures, and services that are otherwise generally available to Medicare beneficiaries) of clinical trials as well as costs related to diagnosis and treatment of complications arising from participation in clinical trials.  An MCA is required for all clinical trials in which routine costs associated with the clinical trial are billed to Medicare or other third-party payers. UCHealth Research Specialists prepare and perform MCAs for all clinical trials conducted at UCHealth. 

Preparing an MCA is a time-consuming and technical process where each of the clinical events specified in the protocol are evaluated to determine the underlying eligibility of the event for Medicare billing and establishes what can be reimbursed by Medicare and other third-party payers for services provided to research participants. The process includes an in-depth analysis of study documents against clinical trial policy rules and proper billing procedure. These billing grids are a valuable tool to ensure appropriate billing compliance and facilitate budget negotiations with the sponsor by providing accurate costs for each research related test or procedure.  An MCA also upholds the obligation of ensuring all claims are accurate before submission.  

All MCAs are entered into OnCore and require Principal Investigator approval prior to a study being opened to accrual.

Effective February 1, 2022, UCHealth will assess a $1,700 fee per initial MCA and a $600 fee per amendment MCA for all new industry-sponsored projects in which costs are billed to Medicare or other third-party payers as part of the IRB approved protocol.  The MCA fee will NOT be assessed for federally funded or investigator-initiated (IIT) projects, including IIT projects with industry support.  All projects submitted to the HSR Portal prior to February 1, 2022, will be exempted (grandfathered) from this fee for initial and amendments.

Any industry-sponsored project submitted after February 1, 2022 to the Human Subjects Research Portal that contains billable services at UCHealth will have this fee assessed.

If you have any questions, please contact Research Administration at [email protected]. 

In order to fulfill our duties as a non-profit and appropriately support research efforts, UCHealth has determined that all industry sponsored research studies should be charged a fee to recover the cost of Medicare Coverage Analysis (MCA) performed by UCHealth Research Administration.

Medicare covers the routine costs (i.e., tests, procedures, and services that are otherwise generally available to Medicare beneficiaries) of clinical trials as well as costs related to diagnosis and treatment of complications arising from participation in clinical trials.  An MCA is required for all clinical trials in which routine costs associated with the clinical trial are billed to Medicare or other third-party payers. UCHealth Research Specialists prepare and perform MCAs for all clinical trials conducted at UCHealth. 

Preparing an MCA is a time-consuming and technical process where each of the clinical events specified in the protocol are evaluated to determine the underlying eligibility of the event for Medicare billing and establishes what can be reimbursed by Medicare and other third-party payers for services provided to research participants. The process includes an in-depth analysis of study documents against clinical trial policy rules and proper billing procedure. These billing grids are a valuable tool to ensure appropriate billing compliance and facilitate budget negotiations with the sponsor by providing accurate costs for each research related test or procedure.  An MCA also upholds the obligation of ensuring all claims are accurate before submission.  

All MCAs are entered into OnCore and require Principal Investigator approval prior to a study being opened to accrual.

Effective February 1, 2022, UCHealth will assess a $1,700 fee per initial MCA and a $600 fee per amendment MCA for all new industry-sponsored projects in which costs are billed to Medicare or other third-party payers as part of the IRB approved protocol.  The MCA fee will NOT be assessed for federally funded or investigator-initiated (IIT) projects, including IIT projects with industry support.  All projects submitted to the HSR Portal prior to February 1, 2022, will be exempted (grandfathered) from this fee for initial and amendments.

Any industry-sponsored project submitted after February 1, 2022 to the Human Subjects Research Portal that contains billable services at UCHealth will have this fee assessed.

If you have any questions, please contact Research Administration at [email protected].