HCMC Utilization & Coverage Analysis Tool

UTILIZATION & COVERAGE ANALYSIS
This tool is required to determine if a study is considered qualified to bill to (1) Medicare (2) Research Study and/ or (3) Third Party Payor.
Questions? Please Email:
Date Prepared: / Prepared By:
Projected Start Date: / Phone:
Projected End Date: / Email:
Study Title:
Principal Investigator:
Department:
PI Phone: / PI Email:
Number of Participants: / Sponsor:
NCT# / HSR#
Must provide prior to patient enrollment / To be completed by Institutional Review Board
Part I. Qualifying Research Protocol
STEP I. Preliminary Analysis
1. Does your NEW Study include patient care services billed in HCMC's Hennepin Health System?
(Patient care services = patient procedures on site, or scheduled within the Hennepin Health System.)
2. If submitting study MODIFICATIONS to IRB, does your modification include changes to patient care services?
3. Does the sponsor pay for ALL patient care services?
(ALL patient care services = standard of care required by protocol research procedures, study drug or device, expanded care.) Nothing billed to insurance
3. Will the research be completed at HCMC or at a satellite clinic?
/ Name of satellite clinic
If you checked "No" proceed to the next question.
If you checked "Yes" STOP! Do not fill out the rest of Part I. Proceed directly to Part 2. Complete Resource Grid to obtain approval for access to HCMC resources.
STEP II. Medicare Qualification
Does this study qualify to bill patient care services under Medicare rules? To determine, follow the questionnaire below.
SECTION 1: Medicare Requirements Coverage of Routine Costs
1. Is the study's purpose to evaluate an item or service that is covered by Medicare?
(Help is available at )
2. Does this study have therapeutic intent?
3. Will this study enroll patients with a diagnosed disease/ condition rather than only healthy volunteers?
If you checked "No" to any question in Section 1, Study does not qualify for Medicare coverage. Proceed to Section 4 and check, "No."
If you checked "Yes" to all question in Section 1, proceed to Section 2.
STEP II. Medicare Qualification (Continued)
SECTION 2: Automatically Qualifying "Deemed" Studies
1. Is the study funded by NIH, CDC, AHRQ, CMS, DOD,or the VA?
(Help is available at )
2. Is the study funded by centers or cooperative groups supported by the above agencies?
3. Is the study conducted under an Investigational New Drug (IND) application reviewed by the FDA?
If "No" proceed to the next question. If you checked "Yes" provide your IND Number. / IND #
4. Is the study exempt from having an IND under 21 CFR 312.2.(b)(1)?
If you check "No" to all questions in Section 2 proceed to Section 3. If you checked "Yes" to any question in Section 2, study qualifies for coverage under Medicare rules. Proceed to Section 4, check "Yes."
SECTION 3: "Desirable" Characteristics
1. Is the principal purpose of the study to test whether the intervention potentially improves participants’ health outcome?
2. Is the study well supported by available scientific and medical information or intended to clarify or establish the health outcomes of interventions already in common clinical use?
3. Do you agree that the study does not unjustifiably duplicate existing studies?
4. Is the study's design appropriate to answer the research question being asked?
5. Is the study sponsored by a credible organization?
6. Is the study in compliance with the Federal regulations relating to the protection of human subjects?
7. Are all aspects of the study conducted according to the appropriate standards to scientific integrity?
If you checked "No" to any question in Section 3, study does not qualify for coverage under Medicare rules. Proceed to Section 4 and check "No." If you checked "Yes" to all 7 questions in Section 3 the study meets requirements for Medicare coverage. meets requirements for Medicare coverage. Proceed to Section 4 and check, "Yes."
SECTION 4: Conclusion
/ Study Qualifies for Medicare Reimbursement
/ Study Does Not Qualify for Medicare Reimbursement but does qualify for Medicare Research Rates
Proceed to page 3- Required HCMC Resource Grid.
UTILIZATION & COVERAGE ANALYSIS
Part 2. HCMC Resource Grid
Use this form to determine if a study is considered qualified to bill to (1) Medicare or to (2) Research Study.
Questions? Please Email:
Please list all HCMC resources to be accessed for the patients being enrolled in the research study. Considerations: Cardiology, Electronic Health Records, Equipment, Laboratory, Pharmacy, Radiology, Other?
Department / Description of Service / CPT/ HCPCS Code / Standard of Care
Cost / Yes / No
PI Signature: / Date:

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