Pamela Richtmyer, MGH Research Compliance

Transcription

1 Pamela Richtmyer, MGH Research Compliance

2 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

3 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

4 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

5 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

6 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)

7 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

8 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

9 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

10 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

11 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?

12 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

13 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?

14 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

15 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

16 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

17 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

18 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

19 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

20 Study Code created in Epic IRB approved protocol, open to enrollment, identified fund linked to protocol and set up properly Epic Study code Example: 2016p (non-oncology) Example: (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

21 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

22 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

23 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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26 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.

27 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

28 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 ilestone%20tracker.pdf OnCore Clinical Trial Management System pilot starting

29 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

30 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

31 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

32 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?

33 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

34 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 Public Settlements 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

35 Partners Clinical Trials Office (CTO) Agreements and Clinical Trial Budgets s/industry-sponsored-basic-research-agreements.aspx MCA dicare-coverage-analysis.aspx Microstrategy Procedure Picker the Help Desk:

36 Research Management Research Finance Partners IRB Informed Consent guidance ects.pdf Core Services Medicare National Coverage Decision nationalcoverage.pdf

37 MGH Research Compliance Clinical Trial Billing Guidelines ubsresearch.aspx Clinical Research Program / Department of Clinical Resarch Epic FAQs Tip Sheets Step by step research billing review slides Sign on with Partners username and password

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