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 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

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

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

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)

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

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

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

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

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?

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

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?

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

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

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

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

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

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

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

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

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

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”

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.

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

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

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

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

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

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?

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

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

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: InsightHelpDesk@partners.org

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

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/

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