partners healthcare - pamela richtmyer, mgh research … · 2016-09-27 · partners clinical trials...
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Pamela Richtmyer, MGH Research Compliance
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September 27 - Session 1 ◦ Basic overview
October 4 - Session 2 ◦ Tracking patient care charges
◦ Invoices to sponsor
◦ Insight Patient Care Corrections
October 11 - Session 3 ◦ Inpatient studies
◦ Medicare Coverage Analysis (MCA
◦ Device study requirements
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Improve ability to assess study costs
Develop study budget that will cover all costs
Determine what is billable to insurance
Appropriate charge direction
Maintain financial health of study
Understand relevant regulations and requirements
Available resources
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Protocol PI vs. Grant PI – not always the same PI responsible for financial management of
study and/or grant ◦ Must ensure that all costs are covered ◦ Expenditures are appropriate and within budget ◦ Compliance with applicable regulations and
requirements Terms and conditions of award or Clinical Trial
Agreement
Scope of work
Federal research regulations
Patient care billing regulations
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Partners Clinical Trials Office (CTO) ◦ Clinical Trial Agreements (industry)
◦ Clinical Trial Budgets
◦ Medicare Coverage Analysis (MCA)
Exception: Cancer Center Protocol Office managed protocols
Microstrategy Procedure Picker
MGH Research Compliance
MGH Department of Clinical Research
Partners Quality Improvement
Partners Research Management/Research Finance
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Study protocol is your guide ◦ Provides the framework for your budget
Target enrollment #
Schedule of events
Study visit details:
# and frequency of visits
Tests and procedures to be done
Proposed budget (Sponsor provided or PI initiated)
Informed Consent template (if provided)
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Hospital/Technical/Facility (HB) ◦ Examples: Lab tests
Procedures (endoscopy, pheresis, x-rays, etc)
Hospital rooms (recovery room, inpatient bed, etc)
Professional (PB) ◦ Examples:
Pathologist review of biopsy
Radiologist review of x-ray
MD performing procedure (endoscopy, surgery, etc)
Important to include both types of charges in budget
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Hospital Charges ◦ Research discount applied when charge posts to
study fund in Insight
◦ Check Procedure Picker for most current discount information
Professional Charges ◦ Amount of research discount depends on fund type
Federal funds – 30% discount
Industry sponsors – 20% /negotiated
Others – no pro fee discount
◦ Discount is applied in Epic
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Procedures may include other charges ◦ Examples:
Liver biopsy – lidocaine, ultrasound guided, conscious sedation, non-PACU recovery
Endoscopy – non-PACU recovery, biopsies (tech and pro fees), specific drugs used for conscious sedation
CTs and MRIs – contrast
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Regulation: PI cannot charge professional fees if has effort on grant
Pro fees will be charged in Epic ◦ PI/Dept. cannot prevent billing
Process: ◦ PI should notify grant manager and study coordinator
regarding % effort on grant ◦ Submit Patient Care Correction – if appropriate revenue
will be reversed
Considerations ◦ Scope of work on project ◦ Service provided ◦ % effort specified on grant
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Sponsor provided template or IRB of record provided template
Study participants should have good understanding of how study services will be charged (21 CFR 50.25) ◦ What will study pay for? Cannot cover co-pays, deductibles, whatever insurance
will not cover Contract between patient and insurance company
◦ What, if anything, will be billed to insurance or the patient?
◦ Who should they contact for billing issues?
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MGH policy: Copy of the signed Informed Consent for research studies should be placed in the medical record if relevant to ongoing medical care
Process: ◦ Send to Health Information Management (HIM) to
scan
◦ Study team can scan using Epic scanner – limited number
◦ Study team can scan and upload – refer to Tip Sheet
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1. Protocol finalized
2. Budget finalized and approved
3. Agreement/Contract in process
4. Informed Consent and other study documents are prepared
5. Study submitted to the IRB
What’s next?
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Medicare revised policy regarding coverage of patient care costs in clinical trials – ◦ Medicare Clinical Trial Policy (effective 2000, revised
2007) Medicare covers routine costs of qualifying clinical trials Includes items and services that are otherwise available to
Medicare beneficiaries
MCA - Partners requirement since January 2008 (MGH, BWH, Spaulding, Faulkner)
MCA determination required prior to IRB approval/activation ◦ 2 categories Qualifying Clinical Trial (QCT) Non-qualifying Clinical Trial
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Qualifying ◦ Full MCA required ◦ 3 criteria mandatory Study must have therapeutic intent Enroll individuals with diagnosed disease Healthy individuals only as controls
Evaluate item or service that Medicare covers ◦ Study-specific billing grid/calendar created PI notified of determination and receives copy of MCA billing
grid Guides charge direction Medicare covers: Usual and customary care, Detection/prevention/treatment of complications, Administration of investigational drug/device
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CTO gets input from PI especially about “usual and customary” care
Not a reimbursement analysis Identifies what is and is not billable to Medicare Does not apply to other payers ◦ Obtain Prior Authorization for study procedures as
needed
Qualitative assessment only Template for Clinical Trial Budget and Epic
Patient Timeline Amendments to study may have an impact on
MCA ◦ Contact CTO as necessary
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Documentation required in medical record to support billing to Medicare or other payers ◦ Same requirement for services outside clinical trial
◦ Support service provided is usual care for patient’s condition
“Patient is a participant in a qualifying clinical trial, PI name, title of study” ◦ Helpful if protocol # referenced
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Non-qualifying ◦ MCA billing grid/calendar not required
◦ PI receives notification of non-qualifying status
◦ Majority of studies
Study pays for all patient care charges OR
No patient care charges in study
◦ Usual and customary services provided outside of study covered as usual
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Make certain fund is set up for patient care charges
Make certain fund type is appropriate for research
Contact CTO if: ◦ You disagree with determination OR
◦ Your study is revised to include usual and customary care that will be billed to insurance
Confirm your budget will cover all costs including patient care professional fees
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Study Code created in Epic ◦ IRB approved protocol, open to enrollment, identified
fund linked to protocol and set up properly
◦ Epic Study code
Example: 2016p001234-123456 (non-Oncology)
Example: 16-952 (Oncology)
◦ Active Epic study code is absolutely essential
Enroll patients in correct study code ◦ Some studies have multiple funding sources
Patient safety
Billing error investigation
Complete Timeline for QCTs
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Link scheduled encounters/visits that meet the following criteria: ◦ Protocol related research and/or usual care visit ◦ MCA – yes or no?
Yes: link visit in Epic
No: does the study visit include any activity that will result in charges to the fund?
Yes: link visit in Epic
No: no link needed
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Use appropriate diagnosis code ◦ Z00.6 = healthy volunteer OR ◦ Correct clinical diagnosis code
Reference full study code on requisitions Link to study Correct test or procedure Order study medication in advance
Refer to Tip Sheets on Research Home Learning
Dashboard or eLearning in HealthStream
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Check “Patients needing billing review (Coordinator)” report daily (Research Billing Review or RBR) 2-3 times/week ◦ Only way to ensure charge review is up to date ◦ Identify others to do review in case of vacations or staff
changes
Direct charges as appropriate: ◦ Study Related – Bill to Study ◦ Not study Related – Bill to Insurance/Patient ◦ Study Related – Bill to Insurance/Patient Qualifying clinical trials
“Mark as reviewed” and accept ◦ Before marking as reviewed make certain charges are in
correct “bucket”
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Charges must be reviewed within 7 days of posting to account in Epic
Escalation Process: ◦ Step 1: On Day 8 notice sent by HB or PB copying PI of fund,
Financial Delegate, coordinator if known, Research compliance
◦ Step 2: On Day 12 notice sent by Research Compliance copying PI of fund and protocol, Financial Delegate, Dept. Administrator, study coordinators
◦ Step 3: On Day 17 notice sent by Research Compliance copying Senior VP of Research, Chief Compliance Officer, PI Dept. Chair, PI Dept. Administrator, Institutional Research Administrator, PHS Research Controller, Director of Revenue, and CFO.
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Epic is a revenue/billing system ◦ Not a Clinical Trial Management System
When you contact the Help Desk let them know your issue is related to “Epic Research” Issue should be assigned to Partners Research E-care team
Departments post charges at different times ◦ Some charges post 2 months after date of service ◦ All charges on HAR will appear on RBR even the charges
already reviewed
Do not use Z00.6 diagnosis code ◦ Automated process for entering appropriate codes and
modifiers on claims
72 hour rule ◦ Billing rule that has impact on charges that route to
research billing review
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Monitor patient care charges ◦ Patient Care Log
◦ Patient Care Details
Communicate with PI and Grant Manager
Access information on Insight home page
Insight Agreements Module
Requires additional access permission
Study Milestone Tracker ◦ http://mghresearch.partners.org/Research_Compliance/documents/Study%20M
ilestone%20Tracker.pdf
◦ OnCore Clinical Trial Management System pilot starting
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Need access to Insight Agreements Module > Fund > Patient Care Details
Each PI, department, study different ◦ Grant Manager
◦ Project Manager
◦ Study Coordinator
◦ PI
Only approved process for research charge correction
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Correction types: Transfers within Research Funds Transfer Insurance/Self Pay to Research Fund Transfer from Research Fund to
Insurance/Self Pay Expected Charge Did Not Post to Fund Incorrect Patient on Fund Current Patient and Fund but Incorrect Charge Confirm Research Rate Charged to Fund
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Complete form correctly ◦ If you do not have all of the required info provide what
you have Make use of resources available to you to find information Refer to other charges on Patient Care Details
Absolutely must provide: Date of Service, MRN, Patient Name, Description of charge, CPT or charge code
Each charge on separate line Technical vs. professional
Caution: Missing vs. late posting Use “Explanation of Correction” text box to
provide critical information ◦ Detail exactly what should be done ◦ Person processing correction does not have same access
in Epic as you do, does not know your study
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All this billing stuff is complicated and confusing!
Who cares where the charges go?
This is the job of billing groups, why do research teams have to do this?
This is just busy work and I don’t have time for this – I have real clinical research work to do like enroll patients, schedule study visits, collect data, completed CRFs, etc.
The charge is standard of care and going to be charged to insurance so what difference does it make if I say it is research related or not?
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Associating an encounter with a study and the Coordinator Research Billing Review are the first of many steps in the billing process
How the charge is reviewed and routed dictates what happens downstream
Billing groups do not know the specific details of your research protocol, informed consent, study budget, or agreement
Accurate and compliant patient care billing is everyone’s responsibility – research teams and billing groups
Study participants get very upset if billed for services covered by the study ◦ Can have a negative impact on continued participation
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Audits and financial settlements ◦ 1993 HHS-OIG Investigation: most of the 130
hospitals investigated were improperly billing Medicare for implanting investigational devices
◦ 1999 GAO Report: Medicare was unknowingly being billed for routine costs in oncology clinical trials. GAO/HEHS-99-182
Public Settlements
2005 - University of Alabama settlement - $3.4 million
2005 – Rush University Medical Center settlement - $1 million
2005 – Weill Cornell Medical Center settlement - $4.3 million
2010 – Tenet Healthcare System, Norris Cancer Center – 1.9 million
Damaged reputation/loss of public trust ◦ Negative impact on research participation
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Partners Clinical Trials Office (CTO) ◦ Agreements and Clinical Trial Budgets https://partnershealthcare.sharepoint.com/sites/phrmInitiate/iian/Page
s/Industry-Sponsored-Basic-Research-Agreements.aspx
◦ MCA https://partnershealthcare.sharepoint.com/sites/phrmInitiate/iian/Pages/Me
dicare-Coverage-Analysis.aspx
Microstrategy Procedure Picker Email the Help Desk: [email protected]
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Research Management – Research Finance https://partnershealthcare.sharepoint.com/sites/phrmDepartments/prd/rf
Partners IRB – Informed Consent guidance https://partnershealthcare-
public.sharepoint.com/ClinicalResearch/Informed_Consent_of_Research_Subjects.pdf
Core Services https://partnershealthcare.sharepoint.com/sites/phrmresources/cs
Medicare National Coverage Decision https://www.cms.gov/Medicare/Coverage/ClinicalTrialPolicies/downloads/final
nationalcoverage.pdf
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MGH Research Compliance ◦ Clinical Trial Billing Guidelines
http://mghresearch.partners.org/Research_Compliance/HumanSubsResearch.aspx
Clinical Research Program / Department of Clinical Resarch ◦ Epic FAQs
◦ Tip Sheets
◦ Step by step research billing review slides
https://hub.partners.org/ecare/
Sign on with Partners username and password
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