CRMS and Clinical Research Financial Clearance...

CRMS and Clinical Research Financial Clearance (CRFC)

Dorothy Damron

April 2012

Contents •Overview of CRMS and the Institution’s Clinical Research Billing Process

•The Insurance Clearance Process in CRMS •Submitting Insurance Clearance in CRMS •Tracking Insurance Clearance •Understanding the Insurance Clearance Response •Definitions •Common Questions

CRMS and Clinical Research Financial Clearance

Overview of CRMS and the Institution’s Clinical Research

Billing Process


CRMS and the Institution’s Clinical Research Billing Process

The Institution’s Clinical Research Management System (CRMS) is a

critical component of the Institution’s Clinical Research

Billing Process.


CRMS and the Clinical Research Billing

If a study has a Prospective Reimbursement Analysis (PRA), study teams are required to submit an electronic Clinical Research Insurance Clearance Form in CRMS before a participant can be on a study.

Clinical Research Insurance Clearance Requests are submitted and tracked in CRMS.

The Clinical Research Billing and Quality Assurance (CRB&QA) team uses the data in CRMS to help make decisions regarding research patients’ bills.


Bill Hold Trigger • Clinical Research Insurance Clearance

triggers a hold on all bills for the study participant

• Clinical Research Billing and Quality Assurance office then: – Refers to CRMS to determine if the subject is enrolled – Refers to CRMS to determine if enrolled subjects continue

on study – Releases charges to participant’s insurance or to research

accounts based on the PRA – Releases participants from pre-bill review hold once a

patient is OFF STUDY or if CRMS shows that the participant did not consent


Institution’s Billing Process Maintain Real-time Data

In addition to submitting Insurance Clearance through CRMS, study staff must keep the following information up-to-date in “real time”:

Consent Date On Study Date

Start Int (Intervention) Date Last Int (Intervention) Date End Int (Intervention) Date

Off Study Date

Billing Compliance makes important decisions based on the information in CRMS!


Institution’s Billing Process Maintain Real-time Data

The following data must be entered in CRMS within 3 business days of the date it occurred

Consent Date On Study Date

Start Int (Intervention) Date Last Int (Intervention) Date

Off Study Date


The Insurance Clearance Process in CRMS


Insurance Clearance Process in CRMS: General

The Clinical Research Insurance Clearance (CRIC) notification and communication process between

Access Services (the team that does the Clearance) and the Study Team

now takes place in CRMS

In future slides, CRIC will be referred to as the Insurance Clearance Process



On the My Studies Tab, you can see if the study has a PRA

The PRA information is also found on the bottom of the Regulatory Tab.




The Insurance Clearance Type, as determined by the Clinical Research Support Services Team (CRSS), found on the bottom of the Regulatory Tab, is automatically added to the Insurance Clearance submission request in CRMS.

It is important to know your studies’ Insurance Clearance Type so that you can accurately follow Institution Policy.

Insurance Clearance Types Insurance Clearance Type for a Study

Institution’s Policy for Participant Study Enrollment

STANDARD You must wait for Insurance Clearance APPROVAL before study-specific screening or enrolling a person on the study

NOTIFICATION Once Insurance Clearance is submitted in CRMS, you can enroll a person on study

RETROSPECTIVE Submit Insurance Clearance in CRMS within 24 hours of enrollment

Be sure to follow Institution policies. This information is automatically added to the request when sent to Access Services.


Insurance Clearance Process in CRMS

•The Study Team will submit the Insurance Clearance request from CRMS and be able to track the clearance process within CRMS.

•While the Access Services team is working the case, information is entered in CRMS.

•The study team is notified of updates via email and views the information via the email link or from the CRMS enrollment tab.

•Icons are used on the Enrollment Tab to represent the status of the Insurance Clearance


Insurance Clearance Icons on CRMS Enrollment Tab

Status Icon

Insurance Clearance Not Submitted

Insurance Request Submitted

Insurance Clearance Request Received

Cancelation Requested

Insurance Clearance Cancelled

Approved

Approved Notification Only

Denied

Denied Not a Covered Benefit

Insurance Clearance Extension Request Insurance Clearance Expired or About to Expire


Submitting Insurance Clearance in CRMS



Step 1: Go to your study in CRMS: https://research-prod.jhmi.edu Step 2: Click on the appropriate study


https://research-prod.jhmi.edu/�


Step 3: “Add Participant” using history number/medical

record number Step 4: Click on the Insurance Clearance Symbol that

was automatically created



Step 5: Click on “New Insurance Clearance Request” Step 6: Complete the online form. Note, if there is an asterisk (*) by the field name you MUST enter information.


Submitting Insurance Clearance in CRMS: Online Form

Step 6 continued • Only select Urgent

Priority if truly urgent! (loss of slot or medical condition)

• Enter participant’s diagnosis as related to the study

• Scroll Down to select one or more Treatment locations for the participant

Routine

High Blood Pressure



Step 6 continued • Select one or more service

areas (use caution – choosing the wrong location can delay your clearance)

• Scroll Down to select one or more study team members who will receive the emails regarding Insurance Clearance (you must select at least one)



Step 6 continued

Based on your Department’s requirements, you may also need to email others such as: • Departmental staff involved in

clearance of difficult cases (transplants), inpatient clearance or those involved in clearance at other Johns Hopkins’ locations



Step 6 continued

• Comments: Add additional information to help the Insurance Clearance Team process this request

• When form is complete, click “Send Request”


Patient has pancreatic cancer and needs to start drug on XXXX


Step 7 Once submitted, the Insurance Clearance Team will get an email alerting them that the participant needs to be cleared. In CRMS, The Insurance Clearance (IC) symbol will change to show that an Insurance Request was submitted (you can roll over the ICON to see the meaning of the symbol) CRMS and Clinical Research Financial Clearance

Tracking Insurance Clearance

Step 8 When the Insurance Clearance Team opens the email, all people listed on the Insurance Clearance submission will receive an email stating that the Insurance Clearance electronic form was received. Due to HIPAA regulations, only the study IRB number is identified in the email.


Tracking Insurance Clearance Step 9 There are 2 ways to see the information from Access Service, regarding your request, you can 1) Open your email and Click on “Insurance

Clearance Response” (You will be taken to CRMS - if you have not logged in recently, you will be prompted for your ID and password)

OR



Step 9 Continued 2) Log into CRMS, go to the study Enrollment

Tab and click on the Insurance Clearance Icon for that specific patient.

The Icon in CRMS will change to show that the IC was received by Access Services.


Tracking Insurance Clearance Step 9 Continued

• When viewing from the

CRMS Enrollment Tab you will first see a synopsis of the information you submitted

Participant’s name



Step 9 Cont. (if viewing from Enrollment Tab) At the bottom of the form, there are 2 options to click on :

1) “Request Cancellation” is used to cancel the Insurance Clearance Request (do not click this unless you really want to cancel the request)

2) “View Response” is used to view information from Access Services regarding your Insurance Clearance Request – choose this


Tracking Insurance Clearance: Response Form

Comments are added by Access Services for the study team to see or act upon if necessary

IC Status shows the current status of the participant’s Insurance Clearance

If viewing from the email link you are taken directly to the Response Form. It took a few more steps to get here when viewing from the CRMS enrollment Tab.



Access Services will continue to work the case and enter information in CRMS. With each update, the study team will get an email showing the status. The study team can follow the link in the email to see the information in CRMS or login to CRMS and click Insurance Clearance Icon. In the example below, the email subject shows that Insurance Clearance was approved


Insurance Clearance in CRMS

Important: It is critical that the study team reviews the information entered in CRMS by the Clearance Team to understand what may or may not be covered by Insurance. The research team needs to discuss this information with the research patient .

Financial Clearance abbreviations can be found

at the end of this document.


Example of an Approved Insurance Clearance Response Form in CRMS

Payer information, authorization dates, and referral dates can be found in the box.

Benefits, Referral and Authorization will be entered under comments

IC Status shows the current status of the participant’s Insurance Clearance


Insurance Clearance Status = Approved


Example of an Approved Insurance Clearance Response Form in CRMS

30 days before an Authorization or Referral is due to expire, the study team will receive a notification to submit for an extension – this is done via the Icon on the Enrollment Tab


Insurance Clearance Status = Approved


Submitting An Extension


Email notification will occur when a patient’s Insurance Clearance is due to expire. This ICON will appear on the Enrollment Tab. Use these guidelines for submitting an extension Patient’s Status on study What to Do

Patient is active on the study Click on Insurance Clearance Icon and submit for an Extension

Patient is still on the study but only in follow-up (e.g., follow-up for survival and no other study-related procedures will be done)

Cancel Insurance Clearance

Patient is off study (no further contact with the patient at all for this study).

Cancel Insurance Clearance and be sure to add an off study date to CRMS. If off study date is already documented in CRMS, the study team will not receive an email.

Patient never went on study (not eligible, not candidate)

In general, you should not receive an email because of the patient’s status. If you do, Cancel Insurance Clearance.

Common Questions about CRMS and the Insurance Clearance Process


Common Questions: What Happens If Insurance Clearance is Denied

If your Department has a process in place for appealing Insurance Clearance denials, the Access Services Team will add the person/team responsible for appeals to the email notification on the CRMS Insurance Clearance Response Form. Access Services must be notified if a denial is overturned. Email with this information. Access Services will update CRMS.


[email protected]

mailto:[email protected]�

Common Questions: What Happens If Insurance Clearance is Denied

Important: If the study team is not appealing the case, CANCEL the Insurance Clearance Request in CRMS immediately!


If a patient want to self-pay, he needs to be given information about the expected cost of the trial. This information can be provided by a financial person within the Departmental or questions can be sent to:


Common Questions: What Happens if Insurance Clearance is Denied and a

Patient Wants to Self Pay

[email protected]


Common Questions: When Should I Cancel Insurance Clearance


Patient Enrollment status becomes

Insurance Clearance state

Not Candidate Cancel Insurance Clearance

Not Eligible Do Not Cancel Insurance Clearance, be sure to document as Not Eligible on the Enrollment Tab

Enrolled and Active on the study Do Not Cancel Insurance Clearance

Candidate, Consent and Eligible are TEMPORARY states. A potential participant should not remain in one of these states.

Common Questions: When Should I Cancel Insurance Clearance

When you submit the cancellation, the Insurance Clearance Team will acknowledge the cancellation in CRMS. Cancelling in a timely manner allows,

1) The Insurance Clearance team to save time by not working on an irrelevant case 2) The Clinical Research Billing and Quality Assurance Team to make sure the patient is not on bill hold for this study. 3) Allows team to resubmit Insurance Clearance at later time


Common Questions: How Do I Cancel Insurance Clearance

1) Click on the Icon

2) Click “Request Cancellation”, at the bottom of the page

3) If you are sure you want to cancel, Click “OK”

Make sure you have the correct person!


Yes, if you cancel Insurance Clearance on a patient and then that patient is potentially eligible to go on the study at a later date, Insurance Clearance can be submitted via the normal CRMS submission process ….. Just click the “Insurance Clearance Cancelled” Icon by the patient’s name and submit your request.

Common Questions: Can I resubmit a Cancelled Insurance Clearance


Common Questions: How do I Submit a Document to the Insurance Clearance Team?

On occasion, the Insurance Clearance Team may need you to provide additional documentation in CRMS in order for them to work the case and obtain clearance on the patient. Uploading documents in CRMS is a secure way to share documents. Access Services plus other study team members will be able to download and see these files.


Common Questions: How do I Submit a Document to the Insurance Clearance Team?

Keep in mind, when adding documents in CRMS, it is important to name them in a sensible way. The following naming convention is recommended: Patient last name, then brief description of document

Example: Smith, XXX document


Common Questions: How do I Upload a Patient-Specific Document in CRMS?

1) Click on “Docs” . This is found on the same line as the patient’s name on the Enrollment Tab.


2) Click on “Upload a New Document”

Patient


3) Complete the following Information 1) Choose Insurance Clearance from the Drop Down

2) Choose ACTIVE status 3) Add a short Title

4) Add a brief description of the document

5) Only add dates if you are tracking documents with different versions

6) Choose: Create document by uploading a file. Then find the file on your computer and add.

7) Choose: Save


4) Your document is now uploaded in CRMS for the Insurance Clearance Team to see. You can upload as many documents as needed.



Security and CRMS

As with any system that contains patient

documents… Do Not view patient documents on a publicly

accessible PC (such as, computers in libraries, internet cafes, etc) or on PCs that are shared with

other people not involved in the study.


Definitions Term Definition

Access Services The team responsible for obtaining Insurance Clearance

Clinical Research Billing and Quality Assurance (CRB&QA)

The team that is responsible for adjudication of clinical research bills

Clinical Research Insurance Clearance (CRIC) notification and communication process

The process of getting Insurance Clearance for a patient who wants to go on a research study

Clinical Research Support Services (CRSS)

The team that develops the Prospective Reimbursement Analysis (PRA)

Health Insurance Portability and Accountability Act (HIPAA)

Federal regulations to assure patient confidentiality



Insurance Clearance Status Current Insurance Clearance status of the research participants as shown by an ICON on the CRMS Enrollment Tab

Insurance Clearance Type: Notification

All services on the study are funded or are considered to be non-therapeutic

Insurance Clearance Type: Standard

There are Standard of Care (SOC) services within the study

Insurance Clearance Type: Retrospective

Patient enrollment required based on participant medical condition

New Insurance Clearance Request “button” in CRMS

Used to open the web-based Insurance Clearance Request Form that is submitted to Access Services



Patient-Specific Document A patient-specific document that is uploaded in CRMS from the Enrollment Tab

Prospective Reimbursement Analysis (PRA)

Document delineating services in the study as SOC or research

Request Cancellation “button” in CRMS

Used to cancel an Insurance Clearance request that was submitted to Access Service

View Response “button” in CRMS Used to view information from Access Services regarding your Insurance Clearance Request


Questions/Problems

If you have any questions about using the Insurance Clearance functionality in CRMS, please email: The CRMS Help Team: [email protected] (for questions about using CRMS) Access Services: [email protected] (for questions about insurance clearance)




GENERAL ABBREVIATIONS FINANCIAL CLEARANCE PROTOCOL

Revised 3/3/2005 (LMC); 03/11/2006; 04/02/2007; 06/10/2007; 04/06/08; 07/01/08; 01/03/09; 07/15/09; 8/13/09; 10/04/200; 11/27/10; 06/08/2011; 07/21/2011;09/28/2011;12/20/2011; 02/09/2012; 03/12/2012

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Use the abbreviations listed below when documenting all Financial Clearance comments. All abbreviations should be entered using capital letters only.

Word/ Phrase Abbreviation (s) Aetna Healthcare AHC And & At @ Authorization AUTH Blue Cross Blue Shield BC/BS; BCBS Bone Marrow Transplant BMT Cardiology CARDY; CARDIO Chemotherapy CHEMO Coinsurance COIN; COINS Consult Treatment Plan CTP Ear Nose & Throat ENT Expiration EXP Family FAM Federal FED Financial Clearance Unit FCU Gynecology GYN Gyn-Oncology GONC; GON In Vitro Fertilization IVF Individual IND Infusion Therapy IFT Inpatient/ Outpatient IPOP Insurance INS Medical Oncology MED ONC Neurology NEURO Number # Nurse Visit N/V; NV Office Visit O/V; OV Oncology ONC Otolaryngology OTO Pain Treatment Center PTC Pediatric Oncology PED ONC Percent % Pre-Authorization PRE-AUTH Pre-Certification PRE-CERT Radiation Oncology RAD ONC Radiation Therapy XRT; RT Radiology RAD Supplement SUPP Supplemental Medical Insurance SMI


Revised 3/3/2005 (LMC); 03/11/2006; 04/02/2007; 06/10/2007; 04/06/08; 07/01/08; 01/03/09; 07/15/09; 8/13/09; 10/04/200; 11/27/10; 06/08/2011; 07/21/2011;09/28/2011;12/20/2011; 02/09/2012; 03/12/2012

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Word/ Phrase Abbreviation (s)

Aetna Healthcare Website (Aetna.com or Healthfusion)

AHC WS

Care First Direct CFD Covered; Coverage COV; CVG Date of Service DOS Deductible DED Eligible ELIG Employer Health Plan EHP Endocrinology ENC Endoscopy ENDO Exclusive Provider Organization EPO Gastroenterology GI Hospital H; HOSP Information INFO International INTL Jai Medical System JAI Johns Hopkins Healthcare JHHC Johns Hopkins Hospital JHH Johns Hopkins Outpatient Center JHOPC; JHOC Johns Hopkins University JHU Life Time Maximum LTM Maryland Physicians Care MPC Medical Assistance M/A Medicare M/C Message MSG Occupational Therapy OT Out-of-Network O-O-N Out-of-Pocket O-O-P Patient PT Pediatrics PEDS Physician P; PHYS Point of Service POS Preferred Provider Network PPN Preferred Provider Organization PPO Primary Care Physician PCP Priority Partners P/P; PP Quality Point of Service QPOS Received RCVD Referral REF Required REQ United Healthcare UHC Workers Compensatation W/C, WC


Revised 3/3/2005 (LMC); 03/11/2006; 04/02/2007; 06/10/2007; 04/06/08; 07/01/08; 01/03/09; 07/15/09; 8/13/09; 10/04/200; 11/27/10; 06/08/2011; 07/21/2011;09/28/2011;12/20/2011; 02/09/2012; 03/12/2012

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Word/ Phrase Abbreviation (s)

Ambulatory Surgical Center ASC Amerigroup AMG Amerigroup Website AMG WS Application Extender AX Call Back C/B Clinical Policy Bulletin CPB Cost per Visit CPV Diagnosis DX; DIAG Effective EFF Financial Counselor FNCL HealthLink EHP HL-EHP HealthLink Priority Partners HL-P/P; HL-PP HealthLink Tricare USFHP HL- Tricare or HL-USFHP Health Services Cost Review Commission HSCRC Kaiser Permanente Website KP WS; K/P WS Lumbar Puncture LP Maximum MAX Outpatient O/P; OP Physical Therapy PT Policy POL Pre-Determination PRE-D Prescription RX Priority Partners and EHP Website MCNET Qualified Medicare Beneficiary QMB Regarding REG Service SVC Services SVCS Social Security # SS# Speech Therapy ST Specified Low Income Medicare Beneficiary SLMB Third Party Administration/Administrator TPA To Call Back TCB Time-of-Service TOS Urology URO Visit VST Website WS, W/S Whitemarsh Ambulatory Surgical Center WM-ASC Wilmer Ambulatory Surgery Center W-ASC Will Call Back WCB Without W/O Women’s Breast & Cervical Cancer Program

BCCP

Year YR

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