Policy describes the shared responsibility for performing the Coverage Analysis
Process in development of a Clinical Study budget. If a Clinical Study requires
patient care items and services (i.e., billable items/procedures/services such
as those with Current Procedural Terminology (CPT), Healthcare Common Procedural
Coding System (HCPCS), Diagnosis-Related Group (DRG) and International
Classification of Diseases (ICD) codes) performed in furtherance of the
Clinical Study, then the Coverage Analysis Process shall be performed, as set out
in this Policy, unless provided an exception by the David Geffen School of
Medicine Clinical Trials Administration Office (CTAO).
This Policy shall apply to
all Clinical Studies regardless of funding source (i.e. extramural industry
funding, extramural non-profit or government funding, and/or intramural
For the purposes of this Policy:
Clinical Study is a research study or trial that
enrolls and/or treats research participants at any UCLA operated facility,
which may result in any charges that the hospital and/or faculty practice group
could charge to a patient, their medical insurer (including but not limited to
government programs), and/or Full Accounting Unit (FAU). A Clinical Study can be sponsored by extramural industry
funding, extramural non-profit or government funding, private sources outside
the University and/or with University discretionary funds.
Coverage Analysis Matrix is a Clinical
Study budget grid that identifies all protocol required procedures and services,
lists the corresponding CPT/HCPCS code and UCLA research price, or designates the
item/service as a routine cost, as defined under the National Coverage Determination
(NCD) and Center for Medicare and Medicaid Services (CMS) Clinical Trials
Coverage Analysis Process is an
analysis to a) determine if the Clinical Study is a Qualifying Clinical Trial and
b) ensure costs for Clinical Study services and procedures are distributed between
research costs and routine costs to ensure proper billing of such costs to
either the Clinical Study Sponsor or a Third Party Payer.
(PI) is a UCLA employee, generally an academic appointee or
individual who has been granted an exception to serve as a PI under UCLA Policy 900, who has primary
responsibility for the scientific and technical conduct, reporting, fiscal and
programmatic administration of any Clinical Study.
Qualifying Clinical Trial is a Clinical Study that
meets the requirements outlined in CMS CTP, which may qualify for reimbursement
of routine costs from a Third Party Payer.
Research Procedures are
the services and items required by the approved Institutional Review Board
protocol and do not meet the definition of routine costs as defined by CMS.
the organization that funds a Clinical Study, often used interchangeably with
Third Party Payer/Payor is an organization other
than the patient (first party) or health care provider (second party) involved
in the financing of personal health services (e.g. Medicare, Medicaid, CHIPS,
CSS, Aetna, Anthem Blue Cross, etc.).
III. POLICY STATEMENT
Study must have a budget that accurately and appropriately allocates the costs associated
with performance of the Clinical Study to the responsible payer (i.e. a Sponsor,
Third Party Payer, or internal funding source) and adheres to UCLA Procedure 915.1,
Pricing for Budgeting and Contracting of Clinical Studies. In order to ensure
costs are allocated to the appropriate entity, the Coverage Analysis Process must
be performed. PIs have primary responsibility for ensuring the Coverage
Analysis Process is performed in compliance with applicable law and this Policy.
PIs must document the proper allocation of Clinical Study costs between Sponsor
or internal funding source, as referenced above, and Third Party Payers through
the Coverage Analysis Process described in this Policy.
Studies that do not comply with this Policy may not be able to begin or utilize
services of a UCLA operated facility. The PI and/or their department may be
responsible for any financial consequences resulting from non-compliance.
below share the responsibility to ensure that Clinical Study costs are properly
analyzed and assessed.
Coordinator, Fund Manager, Department Administrator, collectively, the Study
A. Complete a Qualifying
Clinical Trial Form (QCT Form) to determine if the Clinical Study qualifies
for reimbursement from a Third Party Payer. The PI must confirm and certify the
accuracy of the information provided in the QCT Form.
1. If the Clinical Study is a Qualifying Clinical Trial,
then a Coverage Analysis Matrix must be completed that identifies and
differentiates routine costs that may be billed to the participant and/or any
Third Party Payer from the Research Procedures and services.
2. In collaboration with CTAO, the study team documents
the rationale for differentiation of routine costs and Research Procedures
(e.g., NCDs, Local Coverage Determinations (LCDs), UCLA routine care practices,
acceptable peer-reviewed literature, professional medical organizations or
associations and/or PI or Chair-provided written justification, collectively
referred to as supporting documentation).
3. The Sponsor or other eligible source of funding or
support, other than a Third Party Payer,
must provide for the costs of performing all Research Procedures.
4. If the Clinical Study requires
use of an investigational and/or approved medical device or is an exempt
Investigational New Drug (IND) Clinical Study, the PI must complete the required
QCT Supplement Form in accordance with the instructions set forth therein.
Device trials may require the UCLA Value Analysis Committee review and
approval, and the Director of Reimbursement to submit approval directly to a
Medicare Administrative Contractor.
5. Submit the completed QCT
Form and, as applicable, a Coverage Analysis Matrix, QCT Supplement Form and supporting
documentation (collectively, Coverage Analysis Documents) to the CTAO for
review and certification that the Coverage Analysis Process has been completed.
6. Upon CTAO’s request,
provides clarification, additional supporting documentation and/or revises the
coverage analysis documentation previously provided to comply with this Policy
and applicable law. In the event any discrepancies or inconsistencies remain
unresolved, the appropriate Chairs and the Vice ChancellorHealth Sciences and/or
Research will be consulted.
7. If the Clinical Study is
not a Qualifying Clinical Trial, all costs associated with performance of the
Clinical Study must be provided by the Sponsor.
An abbreviated coverage analysis review may be performed upon receipt of
a signed Principal Investigator Research Only Attestation. In the event the
Sponsor will not provide all costs of performing the Clinical Study, contact CTAO
B. The PI ensures that copies
of the final certified coverage analysis documents are maintained with the
Clinical Study records.
C. The PI ensures that an
updated Coverage Analysis Matrix is completed and submitted to CTAO for any protocol
amendments that add or remove any items, procedures, and/or services of a
Qualifying Clinical Trial.
Administration Office (CTAO)
A. CTAO Clinical Research Analysts/Administrators
(CRAs) review and certify the PI has completed the Coverage Analysis Process and
any outstanding issues have been satisfactorily addressed in accordance with
applicable law and this Policy.
B. CRAs coordinate the distribution
of the final certified coverage analysis documents to the applicable campus
contract and/or grant office. The final certified coverage analysis document
shall be maintained with the Institution’s official contract/grant file.
Chairs and Vice Chancellors
for Health Sciences and Research
the event a discrepancy or inconsistency in the coverage analysis documents
remains unresolved, an ad hoc review group including the CRAs, PI, department
chair and Vice ChancellorHealth Sciences and/or Research may be convened in
order to achieve resolution prior to certification of the coverage analysis documents.
A. QCT Form
B. QCT Supplement Form
C. Coverage Analysis Matrix
D. Principal Investigator
Research Only Attestation
3. UCLA Interim Procedure 915.1, Pricing for Budgeting and Contracting
of Clinical Studies