Does My Study Need a BCA?

Please select the type of research you are conducting to learn about the applicable billing compliance regulations and requirements for your study.

Use of CTRC facilities and services are billed to your study by invoice through InfoPorte. This includes room fees, nursing and nutrition services, EKG without interpretation, and Point of Care testing such as urinalysis, urine pregnancy tests, OGTT, and blood glucose. The Billing Coverage Analysis workbook is not required to be completed in CRMS. Please send the OCT an email (aneiring@email.unc.edu) indicating you have no Epic billing for your study.

However, please be aware that if you order a test or service that takes place during the CTRC visit, but that test or service is processed or completed by UNCHC, the charges ARE billed through Epic, and require completion of the Billing Coverage Analysis workbook. Examples of these types of services are lab tests analyzed by McLendon labs and EKGs with interpretation. Please refer to your specific study type (below) for details regarding BCA completion.

Tip Sheets for Using the CTRC can be found on Research Central:

Screencap of text from Research Central: Clinical and Translational Research Center (CTRC): Changes in the CTRC, Using the CTRC Scheduler, CTRC High Acuity & Inpatient Visits, CTRC Flow Charts, Updating CTRC Account Information, Closing CTRC Encounters Using Epic In Basket

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This study category includes those studies being conducted under an IND, IND-exempt studies, and Phase 4 studies of approved drugs/biologics.

UNC requires completion of the BCA workbook if there are any Epic generated charges regardless of funder or payer. If your study is not a CTRC study (see CTRC category above) and you do not have any Epic generated charges, please send the OCT an email (aneiring@email.unc.edu) indicating you have no Epic billing for your study. Please refer to the chart below to determine which BCA worksheets are required for your study:

Who will pay for procedures and services listed in the protocol of your research study?
Payer Definition Required BCA Worksheets
Bill to sponsor only. Procedures/Services are being done for research purposes only and all will be paid for by the research sponsor.
  • Instructions
  • Coverage Analysis
Bill to sponsor and patientʼs insurance.

BCA Fee Required: $2,000.00 (Except for Federally funded studies.)

Procedures/Services are being done for a mix of research and routine care purposes only.

This may include procedures/services which are done for research purposes or for routine purposes that are paid for by the sponsor or the patientʼs insurance.

  • Instructions
  • Deemed & Qualifying
  • Coverage Analysis
Bill to patientʼs insurance only. All procedures/services are routine care.
  • Instructions
  • Deemed & Qualifying
There is nothing to bill. Study team effort only, no billable procedures/services. BCA Worksheet completion is not required.

HELPFUL HINT: To avoid delay in obtaining account number, email “no Epic billing” and CRMS# to aneiring@email.unc.edu.

 

Instructions worksheet is required. Enter the requested information. Protocol version number and date refer to the version itself (1, 1.2, etc) not the IRB or sponsor study number. If there is none specified, enter “n/a”.

Deemed and qualifying worksheet is required if you intend to bill the patient for routine costs associated with the study. Medicare rules and regulations apply. The National Coverage Determination (NCD 310.1)-final determination requires the study to meet specific criteria in order for you to be able to bill any services to the patient or a third party. Documentation of qualified status is determined by completing the top section of this worksheet. Complete the center section of the worksheet by entering specific information about the drug/biologic. You do NOT have to complete the bottom section pertaining to device studies. If the sponsor/funder is paying for all study related services, you do not have to complete this worksheet.

Coverage Analysis worksheet is required if you have services billed through Epic to the study account, or if you have both study-billed and patient-billed services through Epic. If all charges are billed to the patient, you do not have to complete this worksheet, but you MUST complete the other 2 worksheets.

CRMS and BCA training slides and OnCore training slides, as well as detailed instructions for completing the BCA workbook can be found on Research Central:

Screencap of text from Research Central: Research Administration: Research Administration Handout, CRMS & BCA Training, OnCore Training Slides

Screencap of text from Research Central: Billing Coverage Analysis: Billing Coverage Analysis Instructions, BCA on SharePoint

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This study category includes studies being conducted under an IDE that have been designated as significant risk. In addition to the FDA regulations, CMS has specific billing rules if you plan to bill the device or any routine services associated with the study to the patient (see Deemed and Qualifying worksheet instructions below).

UNC requires completion of the BCA workbook if there are any Epic generated charges regardless of funder or payer. If your study is not a CTRC study (see CTRC category above) and you do not have any Epic generated charges, please send the OCT an email (aneiring@email.unc.edu) indicating you have no Epic billing for your study. Please refer to the chart below to determine which BCA worksheets are required for your study:

Who will pay for procedures and services listed in the protocol of your research study?
Payer Definition Required BCA Worksheets
Bill to sponsor only. Procedures/Services are being done for research purposes only and all will be paid for by the research sponsor.
  • Instructions
  • Coverage Analysis
Bill to sponsor and patientʼs insurance.

BCA Fee Required: $2,000.00 (Except for Federally funded studies.)

Procedures/Services are being done for a mix of research and routine care purposes only.

This may include procedures/services which are done for research purposes or for routine purposes that are paid for by the sponsor or the patientʼs insurance.

  • Instructions
  • Deemed & Qualifying
  • Coverage Analysis
Bill to patientʼs insurance only. All procedures/services are routine care.
  • Instructions
  • Deemed & Qualifying
There is nothing to bill. Study team effort only, no billable procedures/services. BCA Worksheet completion is not required.

HELPFUL HINT: To avoid delay in obtaining account number, email “no Epic billing” and CRMS# to aneiring@email.unc.edu.

 

Instructions worksheet is required. Enter the requested information. Protocol version number and date refer to the version itself (1, 1.2, etc) not the IRB or sponsor study number. If there is none specified, enter “n/a”.

Deemed and qualifying worksheet is required if you intend to bill the patient for routine costs associated with the study. Medicare rules and regulations apply. Documentation of qualified status is determined by completing the bottom section of this worksheet. You do NOT have to complete the top or center sections of the worksheet.

CMS lists all IDE studies that have been approved for billing on their website (link in BCA worksheet). If you do not find your protocol on this website, it is NOT approved for billing. Contact the sponsor for information on whether they intend to submit for approval. If not, you CANNOT bill for any items or services. If the PI holds the IDE, s/he will have to submit to CMS for approval to bill routine items and services: https://www.cms.gov/Medicare/Coverage/IDE/index.html.

Assistance with IDE submissions can be found at:

https://tracs.unc.edu/index.php/services/regulatory/ind-and-ide-application-support/investigational-device-exemptions

Note: If the IDE was initially approved prior to January 1, 2015, please contact Daniel Wayland (Daniel.Wayland@unchealth.unc.edu) for assistance with submitting for approval to bill routine items and services to the Medicare Administrative Contractor for NC, Palmetto GBA.

 If the sponsor/funder is paying for all study related services, you do not have to complete this worksheet.

Coverage Analysis worksheet is required if you have services billed through Epic to the study account, or if you have both study-billed and patient-billed services through Epic. If all charges are billed to the patient, you do not have to complete this worksheet, but you MUST complete the other 2 worksheets.

CRMS and BCA training slides and OnCore training slides, as well as detailed instructions for completing the BCA workbook can be found on Research Central:

Screencap of text from Research Central: Research Administration: Research Administration Handout, CRMS & BCA Training, OnCore Training Slides

Screencap of text from Research Central: Billing Coverage Analysis: Billing Coverage Analysis Instructions, BCA on SharePoint

Screencap of text from Research Central: Other Materials: Frequently Asked Questions, IDE Billing Process, Submitting an ARC Request, Investigational Device Policy

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This study category includes studies of devices which have not been approved or have not been cleared for market under a 510K clearance. There may or may not be an IDE non-significant risk designation assigned by the FDA. These studies are subject to abbreviated FDA IDE regulations. CMS billing regulations apply if you plan to bill the device or any routine services associated with the study to the patient (see Deemed and Qualifying worksheet instructions below).

UNC requires completion of the BCA workbook if there are any Epic generated charges regardless of funder or payer. If your study is not a CTRC study (see CTRC category above) and you do not have any Epic generated charges, please send the OCT an email (aneiring@email.unc.edu) indicating you have no Epic billing for your study. Please refer to the chart below to determine which BCA worksheets are required for your study:

Who will pay for procedures and services listed in the protocol of your research study?
Payer Definition Required BCA Worksheets
Bill to sponsor only. Procedures/Services are being done for research purposes only and all will be paid for by the research sponsor.
  • Instructions
  • Coverage Analysis
Bill to sponsor and patientʼs insurance.

BCA Fee Required: $2,000.00 (Except for Federally funded studies.)

Procedures/Services are being done for a mix of research and routine care purposes only.

This may include procedures/services which are done for research purposes or for routine purposes that are paid for by the sponsor or the patientʼs insurance.

  • Instructions
  • Deemed & Qualifying
  • Coverage Analysis
Bill to patientʼs insurance only. All procedures/services are routine care.
  • Instructions
  • Deemed & Qualifying
There is nothing to bill. Study team effort only, no billable procedures/services. BCA Worksheet completion is not required.

HELPFUL HINT: To avoid delay in obtaining account number, email “no Epic billing” and CRMS# to aneiring@email.unc.edu.

 

Instructions worksheet is required. Enter the requested information. Protocol version number and date refer to the version itself (1, 1.2, etc) not the IRB or sponsor study number. If there is none specified, enter “n/a”.

Deemed and qualifying worksheet is required if you intend to bill the patient for routine costs associated with the study. Medicare rules and regulations apply. Documentation of qualified status is determined by completing the bottom section of this worksheet. You do NOT have to complete the top or center sections of the worksheet.

Approval to bill items and services related to IDE NSR studies is determined by the local Medicare Administrative Contractor (MAC): Medicare Benefit Policy Manual, Chapter 14, section 30. The MAC for NC is Palmetto. The PI will have to submit for approval to bill for the device and/or routine items and services providing the same information to Palmetto as is required to be submitted to CMS for IDE significant risk devices: https://www.cms.gov/Medicare/Coverage/IDE/index.html. For assistance with submitting to Palmetto, contact Daniel Wayland (Daniel.Wayland@unchealth.unc.edu). When you receive the billing determination, Please upload the letter into CRMS. If the determination is via email, please convert to a pdf file and upload. If the sponsor/funder is paying for all study related services, you do not have to complete this worksheet.

Coverage Analysis worksheet is required if you have services billed through Epic to the study account, or if you have both study-billed and patient-billed services through Epic. If all charges are billed to the patient, you do not have to complete this worksheet, but you MUST complete the other 2 worksheets.

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This study category includes studies of devices that are approved or have been cleared for market under the 510K process. The device must be used according to the Instructions for Use manual. If the study objective is for an indication not covered in the IFU, then the protocol must be reviewed for IDE Significant Risk or IDE Non-significant risk determination. Assistance with IDE determinations and submissions can be found at https://tracs.unc.edu/index.php/services/regulatory/ind-and-ide-application-support/investigational-device-exemptions

UNC requires completion of the BCA workbook if there are any Epic generated charges regardless of funder or payer. If your study is not a CTRC study (see CTRC category above) and you do not have any Epic generated charges, please send the OCT an email (aneiring@email.unc.edu) indicating you have no Epic billing for your study. Please refer to the chart below to determine which BCA worksheets are required for your study:

Who will pay for procedures and services listed in the protocol of your research study?
Payer Definition Required BCA Worksheets
Bill to sponsor only. Procedures/Services are being done for research purposes only and all will be paid for by the research sponsor.
  • Instructions
  • Coverage Analysis
Bill to sponsor and patientʼs insurance.

BCA Fee Required: $2,000.00 (Except for Federally funded studies.)

Procedures/Services are being done for a mix of research and routine care purposes only.

This may include procedures/services which are done for research purposes or for routine purposes that are paid for by the sponsor or the patientʼs insurance.

  • Instructions
  • Deemed & Qualifying
  • Coverage Analysis
Bill to patientʼs insurance only. All procedures/services are routine care.
  • Instructions
  • Deemed & Qualifying
There is nothing to bill. Study team effort only, no billable procedures/services. BCA Worksheet completion is not required.

HELPFUL HINT: To avoid delay in obtaining account number, email “no Epic billing” and CRMS# to aneiring@email.unc.edu.

 

Instructions worksheet is required. Enter the requested information. Protocol version number and date refer to the version itself (1, 1.2, etc) not the IRB or sponsor study number. If there is none specified, enter “n/a”.

Deemed and qualifying worksheet is required if you intend to bill the patient for routine costs associated with the study. Medicare rules and regulations apply. The National Coverage Determination (NCD 310.1)-final determination requires the study to meet specific criteria in order for you to be able to bill any services to the patient or a third party. Documentation of qualified status is determined by completing the top section of this worksheet. Complete the bottom section pertaining to device studies. You do not have to complete the center section pertaining to drug/biologic studies. If the sponsor/funder is paying for all study related services, you do not have to complete this worksheet.

Coverage Analysis worksheet is required if you have services billed through Epic to the study account, or if you have both study-billed and patient-billed services through Epic. If all charges are billed to the patient, you do not have to complete this worksheet, but you MUST complete the other 2 worksheets.

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UNC requires completion of the BCA workbook if there are any Epic generated charges regardless of funder or payer. If your study is not a CTRC study (see CTRC category above) and you do not have any Epic generated charges, please send the OCT an email (aneiring@email.unc.edu) indicating you have no Epic billing for your study. Please refer to the chart below to determine which BCA worksheets are required for your study:

Who will pay for procedures and services listed in the protocol of your research study?
Payer Definition Required BCA Worksheets
Bill to sponsor only. Procedures/Services are being done for research purposes only and all will be paid for by the research sponsor.
  • Instructions
  • Coverage Analysis
Bill to sponsor and patientʼs insurance.

BCA Fee Required: $2,000.00 (Except for Federally funded studies.)

Procedures/Services are being done for a mix of research and routine care purposes only.

This may include procedures/services which are done for research purposes or for routine purposes that are paid for by the sponsor or the patientʼs insurance.

  • Instructions
  • Deemed & Qualifying
  • Coverage Analysis
Bill to patientʼs insurance only. All procedures/services are routine care.
  • Instructions
  • Deemed & Qualifying
There is nothing to bill. Study team effort only, no billable procedures/services. BCA Worksheet completion is not required.

HELPFUL HINT: To avoid delay in obtaining account number, email “no Epic billing” and CRMS# to aneiring@email.unc.edu.

 

Instructions worksheet is required. Enter the requested information. Protocol version number and date refer to the version itself (1, 1.2, etc) not the IRB or sponsor study number. If there is none specified, enter “n/a”.

Deemed and qualifying worksheet is required if you intend to bill the patient for routine costs associated with the study. Medicare rules and regulations apply. The National Coverage Determination (NCD 310.1)-final determination requires the study to meet specific criteria in order for you to be able to bill any services to the patient or a third party. Documentation of qualified status is determined by completing the top section of this worksheet. You do NOT have to complete the center or bottom sections pertaining to drug or device studies. If the sponsor/funder is paying for all study related services, you do not have to complete this worksheet.

Coverage Analysis worksheet is required if you have services billed through Epic to the study account, or if you have both study-billed and patient-billed services through Epic. If all charges are billed to the patient, you do not have to complete this worksheet, but you MUST complete the other 2 worksheets.

CRMS and BCA training slides and OnCore training slides, as well as detailed instructions for completing the BCA workbook can be found on Research Central:

Screencap of text from Research Central: Research Administration: Research Administration Handout, CRMS & BCA Training, OnCore Training Slides

Screencap of text from Research Central: Billing Coverage Analysis: Billing Coverage Analysis Instructions, BCA on SharePoint

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This study category includes studies of therapies like radiation treatment or physical therapy or procedures such as surgical or imaging methodology. Please note: if an imaging study focus is a contrast agent, this would be categorized as a drug study, or if new software for imaging is the focus, this would be a device study.

UNC requires completion of the BCA workbook if there are any Epic generated charges regardless of funder or payer. If your study is not a CTRC study (see CTRC category above) and you do not have any Epic generated charges, please send the OCT an email (aneiring@email.unc.edu) indicating you have no Epic billing for your study. Please refer to the chart below to determine which BCA worksheets are required for your study:

Who will pay for procedures and services listed in the protocol of your research study?
Payer Definition Required BCA Worksheets
Bill to sponsor only. Procedures/Services are being done for research purposes only and all will be paid for by the research sponsor.
  • Instructions
  • Coverage Analysis
Bill to sponsor and patientʼs insurance.

BCA Fee Required: $2,000.00 (Except for Federally funded studies.)

Procedures/Services are being done for a mix of research and routine care purposes only.

This may include procedures/services which are done for research purposes or for routine purposes that are paid for by the sponsor or the patientʼs insurance.

  • Instructions
  • Deemed & Qualifying
  • Coverage Analysis
Bill to patientʼs insurance only. All procedures/services are routine care.
  • Instructions
  • Deemed & Qualifying
There is nothing to bill. Study team effort only, no billable procedures/services. BCA Worksheet completion is not required.

HELPFUL HINT: To avoid delay in obtaining account number, email “no Epic billing” and CRMS# to aneiring@email.unc.edu.

 

Instructions worksheet is required. Enter the requested information. Protocol version number and date refer to the version itself (1, 1.2, etc) not the IRB or sponsor study number. If there is none specified, enter “n/a”.

Deemed and qualifying worksheet is required if you intend to bill the patient for routine costs associated with the study. Medicare rules and regulations apply. The National Coverage Determination (NCD 310.1)-final determination requires the study to meet specific criteria in order for you to be able to bill any services to the patient or a third party. Documentation of qualified status is determined by completing the top section of this worksheet. You do NOT have to complete the center or bottom sections pertaining to drug or device studies. If the sponsor/funder is paying for all study related services, you do not have to complete this worksheet.

Coverage Analysis worksheet is required if you have services billed through Epic to the study account, or if you have both study-billed and patient-billed services through Epic. If all charges are billed to the patient, you do not have to complete this worksheet, but you MUST complete the other 2 worksheets.

CRMS and BCA training slides and OnCore training slides, as well as detailed instructions for completing the BCA workbook can be found on Research Central:

Screencap of text from Research Central: Research Administration: Research Administration Handout, CRMS & BCA Training, OnCore Training Slides

Screencap of text from Research Central: Billing Coverage Analysis: Billing Coverage Analysis Instructions, BCA on SharePoint

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True observational studies would by definition not include any intervention, therefore there would be no billing. However, the term is used informally for studies that include specimen collection. If a specimen is to be collected (blood draw or biopsy) and hospital services will be utilized, a coverage analysis will need to be completed. Please refer to the “Specimen” study category for billing compliance information.

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This study category includes studies of tissue and blood samples. If samples are to be obtained from “extra” tissue obtained during standard of care procedures (extra tube of blood or piece of SOC biopsy) or if research staff will be drawing blood, no coverage analysis is needed. Please send an email to aneiring@email.unc.edu to indicate “No Epic billing”.

If you will need to use hospital phlebotomy services for blood draws, or may need to perform biopsies if no standard of care tissue is available, or will require archived tissue retrieval and preparation, you will need to complete a coverage analysis. Please refer to the chart below to determine which BCA worksheets are required for your study:

Who will pay for procedures and services listed in the protocol of your research study?
Payer Definition Required BCA Worksheets
Bill to sponsor only. Procedures/Services are being done for research purposes only and all will be paid for by the research sponsor.
  • Instructions
  • Coverage Analysis
Bill to sponsor and patientʼs insurance.

BCA Fee Required: $2,000.00 (Except for Federally funded studies.)

Procedures/Services are being done for a mix of research and routine care purposes only.

This may include procedures/services which are done for research purposes or for routine purposes that are paid for by the sponsor or the patientʼs insurance.

  • Instructions
  • Deemed & Qualifying
  • Coverage Analysis
Bill to patientʼs insurance only. All procedures/services are routine care.
  • Instructions
  • Deemed & Qualifying
There is nothing to bill. Study team effort only, no billable procedures/services. BCA Worksheet completion is not required.

HELPFUL HINT: To avoid delay in obtaining account number, email “no Epic billing” and CRMS# to aneiring@email.unc.edu.

 

Instructions worksheet is required. Enter the requested information. Protocol version number and date refer to the version itself (1, 1.2, etc) not the IRB or sponsor study number. If there is none specified, enter “n/a”.

Coverage Analysis worksheet is required if you have services billed through Epic to the study account.

CRMS and BCA training slides and OnCore training slides, as well as detailed instructions for completing the BCA workbook can be found on Research Central:

Screencap of text from Research Central: Research Administration: Research Administration Handout, CRMS & BCA Training, OnCore Training Slides

Screencap of text from Research Central: Billing Coverage Analysis: Billing Coverage Analysis Instructions, BCA on SharePoint

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Registries typically do not include any billable items or services. Occasionally, however, a registry study will include specimen collection. If a specimen is to be collected (blood draw or biopsy) and hospital services will be utilized, a coverage analysis will need to be completed. Please refer to the “Specimen” study category for billing compliance information.

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