Part VII: Plan Codes and Other Billing Issues

Scheduling, Registration & Billing

PART III: SCHEDULING, REGISTRATION, BILLING, AND PAYMENT FOR RESEARCH SERVICES
Table of Contents / Page
Introduction / 2
Scheduling Research / 2
Research Orders / 3
The Research Registration Form / 9
Research Participant Visit Bill Review
Research Visit Cover Letter & Discount Table
Research Participant Visit Charge Report
Completing Research Participant Bill Review / 15
Payment for Investigational Services
Understanding the Research Vendor Account
Allina Health Billing Statements and SPA Reporting
Submitting Payments / 24
Research Site Detail Aging Report / 29
Research Participants with Medicare Replacement (MR) (aka., Medicare Advantage or Medicare Part C Plans) / 30
List of Medicare Advantage/Replacement Plans / 30
Reporting Treatment for Complications Related to Study / 31

Scheduling, Registration & Billing

Introduction

Allina Health Sponsored Projects Administration (SPA) is responsible for ensuring research participant bills and claims submitted to government payers are consistent with published Medicare and Medicaid regulations related to research billing. Part III of the SPA Research Billing Compliance Guide outlines the post-SPA approval processes for services related to the study that are provided at Allina Health facilities. Part III focuses on research participant scheduling, registration, billing, and payment for research services.

Scheduling Research at Allina Health

Prior to scheduling a research visit at Allina Health, the research site should be familiar with the study Schedule of Events (SOE) and have already identified the billable and non-billable services on the SOE that was submitted to SPA.

Secondly, a research site should have been assigned a Research Plan Code that is unique to the research site and can be used for scheduling and registration of visits for all studies conducted by that site. The research plan code functions to stop the bill for research review prior to billing insurance or patient for services.

Scheduling a Research Participant Visit

Scheduling a research visit within an Allina Health hospital is really no different than scheduling a non-research visit. The research site should contact the appropriate department to schedule the service or if you access Excellian, Allina Health’s electronic medical record, services may be scheduled within the system.

Research Only Service(s)

If any of the items or services being scheduled are research only (i.e., not billable to insurance) communicate the following at time of scheduling:

· This visit is a research visit;

· The Research Plan Code (Research Plan Codes are assigned by SPA to each research site for billing); and

· Any additional requirements related to the service.

Routine Care Services

If all of the items and services are routine care (i.e., billable to patient or their insurance) then the service can be scheduled as any other service.

For full definitions of what is billable and non-billable see Part I: Research Billing Guidance, Medicare CTP.

Scheduling, Registration & Billing

Research Orders

Allina Health requires that all services performed be ordered by an authorized medical provider. Allina Health must have a valid verbal or hard copy of the medical order before it is able to perform a service whether it is research or not. To ensure research information is communicated upon ordering a service, orders for study related services have additional requirements to the normal ordering procedure for a specific Allina Health hospital or clinic department.

A common requirement for research orders is the V70.7 diagnosis code defined here:

V70.7 Diagnosis Code is an ICD-9 Code assigned to visits that are research related (listed on the study Schedule of Events). V70.7 translates on a claim as “Examination of a participant in a clinical trial”. It is a billable code and is required for Medicare, Medicaid, and Medicare Advantage/Replacement beneficiaries.

Hard Copy (Faxed/Manual) Orders

In addition to meeting any hospital or clinic requirements for hard copy orders, all hard copy orders for research (non-billable) services should also include:

1. Research Plan Code information

2. V70.7 research diagnosis

All hard copy orders for Medicare/Medicaid patients and routine care (billable) services should include:

1. Primary diagnosis

2. V70.7 research diagnosis

Excellian Research Orders (Procedures Only)

This is only applicable to those sites using Excellian to order research services.

Outpatient

Following are the instructions for completing orders for outpatient procedures paid for by study (currently does not include physician office visits and other non-procedural visits). Outpatient procedure visits that are non-billable require a V70.7 diagnosis on the order.

1. Open Order Encounter

2. Click Go To Order Entry

3. Enter Order (per Excellian Ordering Procedures)

4. Add a diagnosis from problem list. This will be secondary to the research diagnosis and is required.

4. Enter “research” in the diagnosis text box and key Enter.

5. The V70.7 selection will appear highlighted, key Enter or Accept Selection button.

6. The order will display both of the diagnosis selected. Highlight the EXAM OF PARTICIPANT IN CLINICAL TRIAL [V70.7] and select Primary Dx button (X should appear under row with P header).

7. Enter Associated Diagnosis as “1,2” in text box. Key Enter.

8. To enter Comments, highlight order and click Full Detail button.

9. In Comments text box, enter “Research Plan Code #” and trial name. Key Enter.

10. V70.7 Diagnosis has now been added to the order. Complete the service order according to Excellian Ordering Procedures.

Scheduling, Registration & Billing

Inpatient

Inpatient Orders for procedures that will be paid for by the research study (non-billable services) should have the V70.7 diagnosis listed as primary and “Research Plan Code #” entered in the Comments.

To complete an IP research order with the requirements above, please follow the steps below:

1. Enter the order using Order Entry

2. Select the Order (use Excellian Order Procedures)

3. Select the Full Detail button on upper right hand corner of the order.

4. In the Full Detail window, choose Diagnosis from the left hand menu.

5. Key “Research” in the Encounter Diagnoses text area and key ‘Enter’. A database match will appear with the V70.7 diagnosis.

6. Select Accept Selection button

7. Enter “Research Plan Code #” in the Comments (F6): text area. Note: Research Plan Code # is assigned by SPA to each research site.

8. Select Accept button

9. Complete the rest of the order using Excellian IP order entry procedures.

The Research Registration Form

The Research Registration Form (RRF) is the tool research sites must use to notify Allina Health of research participant visits that meet research billing criteria for reporting to Allina Health Sponsored Projects Administration (SPA). SPA uses the RRF information to meet research billing compliance requirements. The RRF will assist Allina Health with the appropriate registration of the research participant for bill review, coding research accounts, and notification to the hospital an investigation medical device was used. Appropriate and timely submission of the RRF is integral to the success of Allina Health’s research billing compliance.

When Research Registration Form Is Required

The Research Registration Form must be sent to SPA on or before a research participant date of service if it meets any one of the following criteria:

1) Items or services are paid for by the study during the date of service or inpatient stay;

2) The participant is a Medicare, Medicaid, or Medicare Advantage/Replacement Plan (see listing of Medicare Replacement plans) beneficiary;

3) A study medical device will be or was used or replaced during date of service or inpatient stay; or

4) The participant received treatment for complications related to the study.

When to Submit the Research Registration Form

1) Submit the Research Registration Form before or up to the date of the service

2) During an Inpatient stay as soon as it is known the participant had a service requiring the submission of the Research Registration Form

3) Only one of the four criteria must be met in order for the form to be required for the participant date of service

4) One form is required for each participant date of service at Allina.

Accessing the Research Registration Form

The Research Registration Form is available on Allina Health SPA web site.

To access through www.Allina Health.com home page:

Click on For Providers tab at top of page

Under Helpful Links menu, click on Allina Health Research Administration

From left-hand menu, click on “Sponsored Projects Administration”

Scroll down and select Research Registration Form link.

Completing the Research Registration Form

The following describes each section of the form in detail and the required information.

Instructions

· Research site must review the bill because services may be paid for by study (RPC Yes) – Check this box if the services required during this visit may include Research Only services. The Research Plan Code (RPC) is applied to the visit to prevent billing a third party payer. The Research Plan Code is a code given to each research site and when applied to a participant account will stop the bill so it can be reviewed for non-billable charges.

· The participant has insurance from Medicare, Medicare Replacement, Medicaid, or SPA should check coverage to ensure it is not a government payer – if the participant has one of the government payers listed, the box must be checked and the RRF submitted. If the research site does not know the participant’s insurance, but wants SPA to check if it could be a government payer previously listed, check this box and SPA will verify the insurance coverage.

· A study medical device was/will be used or replaced on this date of service – Check this box only if a medical study device was used/implanted during this visit. If an approved medical device was implanted as part of the study, the device should be reported. The Medical Device Information section should also be completed.

· Treatment for complication directly related to the study drug, device, or intervention –Treatment for complications related to the study only need to be reported to SPA if it can be determined that the complication is directly related to the study intervention including drug, device, or procedure, and the participant is a Medicare, Medicaid, or Medicare Replacement beneficiary.

Research Participant Information

If completing form by hand, please print clearly

· Name – Enter first and last name of participant and middle initial if known

· Date of Birth – Enter participant date of birth

Research Service Information

One form is required for each outpatient date of service or inpatient stay.

· Date of Service:

o Outpatient – enter date of service

o Inpatient – enter admit date, discharge date, or any date in between

o Research Medical Device Use – enter date device was implanted/used

· Patient Class – Check any that apply to date of service:

o Outpatient – patient is classified as outpatient, generally not an overnight stay or on observation

o Inpatient – patient is classified as inpatient

o Allina Health Physician Visit – visit includes an Allina Health physician/doctor consult

o Clinic Visit – visit will be at an Allina affiliated clinic

· Allina Health Facility – Check appropriate hospital, or if Other Allina Health Facility (not listed), please indicate full name of facility in space provided.

· Study Visit Type (optional) – Not required. Check the appropriate box if it is one of the following types of services:

o Labs – If the visit is only labs that are billed by the hospital and not using a Allina Health Lab Requisition Form

o Imaging/Diagnostics – Check this box if imaging or diagnostics is the only service

o Other/Visit # (optional) – Not required. May be used for research site tracking of participant’s visit.

Research Medical Device Information

Complete this section only if a research medical device is used for this date of service or check N/A (not applicable) box. This section will be used by Allina Health for appropriate billing of the research medical device.

· Device Name – Enter full device name

· Location – Check the appropriate location: Allina Health OR, Cath Lab, Interventional Radiology (IR) or Other, (Example: CV OR is Other).

· Physician Name – Enter first and last name of physician providing service

· Device Type – Check appropriate type of research medical device

o IDE – Investigation Device Exemption

o HDE – Humanitarian Device Exemption

o PMA – Post Market Approved

o Approved – 510(k) or other approved device used in a study

o Replacement – check if the device is a replacement for a study device (may be checked in addition to other Device Type category)

o Other – A device used within a research study, but doesn’t fit the other categories (e.g., Non-Significant Risk)

· FDA Assigned # - Enter FDA device assignment (IDE’s usually begin with a ‘G’ and PMA’s with a ‘P’). If none, enter “none”

Research Site, Study, and Contact Information

· Research Plan Code – enter numeric research plan code given to the research site

· Research Site Name – enter name of research site conducting study (may be short or abbreviated name)

· Study Short Name or Protocol # – enter unique study name. If short name is available, that is acceptable. For oncology groups, protocol # is acceptable.

· SPA ID or Allina Health IRB Protocol # - enter Sponsored Projects Administration (SPA) eProtocol ID or if unknown, provide Allina Health IRB eProtocol ID. One or the other is required.

· Contact Name & Phone– enter name and phone number of research site contact if SPA has questions about the research visit or form information

Submitting the Form

The form can be either faxed to 612-262-4953 or sent via e-mail to . If sending via e-mail, the sender must either have an Allina.com e-mail address or be able to send secure e-mail.

Questions

Contact SPA at 612-262-4924 or send email to

Scheduling, Registration & Billing

Research Participant Visit Bill Review

If the Research Registration Form was submitted to SPA and the Research Plan Code section was checked “Yes”, SPA will send the research participant’s bill to the research site for review. The participant’s bill includes all charges entered for the entire visit or hospital stay. Participant bills are mailed to the research site approximately four days after discharge. It is the research site’s responsibility to identify all non-billable research items and services on the participant’s bill and return to SPA within twenty-one (21) days of receipt.