WIXLIB

Pamela Richtmyer, MGH Research Compliance

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

Improve ability to assess study costsDevelop study budget that will cover all costsDetermine what is billable to insuranceAppropriate charge directionMaintain financial health of studyUnderstand relevant regulations andrequirementsAvailable resources

Protocol PI vs. Grant PI – not always the samePI responsible for financial management ofstudy and/or grant Must ensure that all costs are covered Expenditures are appropriate and within budget Compliance with applicable regulations andrequirements Terms and conditions of award or Clinical TrialAgreement Scope of work Federal research regulations Patient care billing regulations

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 PickerMGH Research ComplianceMGH Department of Clinical ResearchPartners Quality ImprovementPartners Research Management/Research Finance

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 PIinitiated)Informed Consent template (if provided)

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 inbudget

Hospital Charges Research discount applied when charge posts tostudy fund in Insight Check Procedure Picker for most current discountinformation 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

Procedures may include other charges Examples: Liver biopsy – lidocaine, ultrasound guided, conscioussedation, non-PACU recovery Endoscopy – non-PACU recovery, biopsies (tech andpro fees), specific drugs used for conscious sedation CTs and MRIs – contrast

Regulation: PI cannot charge professional fees ifhas effort on grantPro fees will be charged in Epic PI/Dept. cannot prevent billing Process: PI should notify grant manager and study coordinatorregarding % effort on grant Submit Patient Care Correction – if appropriate revenuewill be reversed Considerations Scope of work on project Service provided % effort specified on grant

Sponsor provided template or IRB of recordprovided templateStudy participants should have goodunderstanding of how study services will becharged (21 CFR 50.25) What will study pay for? Cannot cover co-pays, deductibles, whatever insurancewill not cover Contract between patient and insurance company What, if anything, will be billed to insurance or thepatient? Who should they contact for billing issues?

MGH policy: Copy of the signed InformedConsent for research studies should beplaced in the medical record if relevant toongoing medical careProcess: Send to Health Information Management (HIM) toscan Study team can scan using Epic scanner – limitednumber Study team can scan and upload – refer to Tip Sheet

1.2.3.4.5.Protocol finalizedBudget finalized and approvedAgreement/Contract in processInformed Consent and other studydocuments are preparedStudy submitted to the IRBWhat’s next?

Medicare revised policy regarding coverage ofpatient care costs in clinical trials – Medicare Clinical Trial Policy (effective 2000, revised2007) Medicare covers routine costs of qualifying clinical trials Includes items and services that are otherwise available toMedicare beneficiaries MCA - Partners requirement since January 2008(MGH, BWH, Spaulding, Faulkner)MCA determination required prior to IRBapproval/activation 2 categories Qualifying Clinical Trial (QCT) Non-qualifying Clinical Trial

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 billinggrid Guides charge direction Medicare covers: Usual and customary care, Detection/prevention/treatment of complications, Administration of investigational drug/device

CTO gets input from PI especially about “usualand customary” careNot a reimbursement analysisIdentifies what is and is not billable to MedicareDoes not apply to other payers Obtain Prior Authorization for study procedures asneededQualitative assessment onlyTemplate for Clinical Trial Budget and EpicPatient TimelineAmendments to study may have an impact onMCA Contact CTO as necessary

Documentation required in medical record tosupport billing to Medicare or other payers Same requirement for services outside clinical trial Support service provided is usual care for patient’scondition “Patient is a participant in a qualifying clinicaltrial, PI name, title of study” Helpful if protocol # referenced

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 ofstudy covered as usual

Make certain fund is set up for patient carechargesMake certain fund type is appropriate forresearchContact CTO if: You disagree with determination OR Your study is revised to include usual andcustomary care that will be billed to insurance Confirm your budget will cover all costsincluding patient care professional fees

Study Code created in Epic IRB approved protocol, open to enrollment, identifiedfund 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

Link scheduled encounters/visits that meetthe 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 thatwill result in charges to the fund? Yes: link visit in Epic No: no link needed

Use appropriate diagnosis code Z00.6 healthy volunteerOR Correct clinical diagnosis code Reference full study code on requisitionsLink to studyCorrect test or procedureOrder study medication in advanceRefer to Tip Sheets on Research Home LearningDashboard or eLearning in HealthStream

Check “Patients needing billing review(Coordinator)” report daily (Research BillingReview 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 staffchanges 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 incorrect “bucket”

Charges must be reviewed within 7 days ofposting to account in EpicEscalation Process: Step 1: On Day 8 notice sent by HB or PB copying PI of fund,Financial Delegate, coordinator if known, Researchcompliance Step 2: On Day 12 notice sent by Research Compliancecopying PI of fund and protocol, Financial Delegate, Dept.Administrator, study coordinators Step 3: On Day 17 notice sent by Research Compliancecopying Senior VP of Research, Chief Compliance Officer, PIDept. Chair, PI Dept. Administrator, Institutional ResearchAdministrator, PHS Research Controller, Director ofRevenue, and CFO.

Epic is a revenue/billing system When you contact the Help Desk let them know yourissue is related to “Epic Research” Not a Clinical Trial Management System Issue should be assigned to Partners Research E-care team Departments post charges at different times Do not use Z00.6 diagnosis code 72 hour rule Some charges post 2 months after date of service All charges on HAR will appear on RBR even the chargesalready reviewed Automated process for entering appropriate codes andmodifiers on claims Billing rule that has impact on charges that route toresearch billing review

Monitor patient care charges Patient Care Log Patient Care Details Communicate with PI and Grant ManagerAccess information on Insight home pageInsight Agreements ModuleRequires additional access permissionStudy Milestone Tracker http://mghresearch.partners.org/Research df OnCore Clinical Trial Management System pilot starting

Need access to Insight Agreements Module Fund Patient Care DetailsEach PI, department, study different Grant ManagerProject ManagerStudy CoordinatorPIOnly approved process for research chargecorrection

Correction types: Transfers within Research Funds Transfer Insurance/Self Pay to Research Fund Transfer from Research Fund toInsurance/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

Complete form correctly If you do not have all of the required info provide whatyou 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, PatientName, Description of charge, CPT or charge code Each charge on separate line Technical vs. professional Caution: Missing vs. late postingUse “Explanation of Correction” text box toprovide critical information Detail exactly what should be done Person processing correction does not have same accessin Epic as you do, does not know your study

All this billing stuff is complicated and confusing!Who cares where the charges go?This is the job of billing groups, why do researchteams have to do this?This is just busy work and I don’t have time forthis – I have real clinical research work to do likeenroll patients, schedule study visits, collectdata, completed CRFs, etc.The charge is standard of care and going to becharged to insurance so what difference does itmake if I say it is research related or not?

Associating an encounter with a study and theCoordinator Research Billing Review are the first ofmany steps in the billing processHow the charge is reviewed and routed dictates whathappens downstreamBilling groups do not know the specific details of yourresearch protocol, informed consent, study budget,or agreementAccurate and compliant patient care billing iseveryone’s responsibility – research teams and billinggroupsStudy participants get very upset if billed for servicescovered by the study Can have a negative impact on continued participation

Audits and financial settlements 1993 HHS-OIG Investigation: most of the 130hospitals investigated were improperly billingMedicare for implanting investigational devices 1999 GAO Report: Medicare was unknowingly beingbilled 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 millionDamaged reputation/loss of public trust Negative impact on research participation

Partners Clinical Trials Office (CTO) Agreements and Clinical Trial sic-Research-Agreements.aspx s.aspx Microstrategy Procedure PickerEmail the Help Desk: InsightHelpDesk@partners.org