Pamela Richtmyer, MGH Research Compliance

September 27 - Session 1 Basic overview

October 4 - Session 2 Tracking patient care charges

Insight Patient Care Corrections

Invoices to sponsor

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

Link the admission in Epic PHS ADT Expected Admissions (Preadmissions) to Link to

Study Report – on Epic Dashboard Must be done in advance of scheduled admission

PHS ADT Inpatient Admission, HOV, or ED to Link to Study Report - on Epic Dashboard Must be linked prior to day of discharge

Research Orders for inpatients Research staff cannot enter orders for inpatients Licensed provider must enter and sign order Coordinate with inpatient clinical Blood specimens collected by inpatient nursing staff

Separate process for Emergency Department

Technical charges post to Research Billing Review report once discharged All charges from admission will route to the report for

review Helpful hints:

Select All option available

Sort charges by date of service or charge description

Professional fees can post daily Be aware of 72 hour rule Late charges an issue Entire account appears Green check marks indicate charges already reviewed

Any research protocols involving the ED must be reviewed and approved by the ED Includes recruiting participants in ED

Contact Blair Parry

ED approved studies Meet with ED prior to study start to verify process

Research coordinators can enter orders

Research coordinators can perform phlebotomy in ED

Certification required

Use ED Track Board to identify potential subjects

FDA regulations – types of device studies Significant risk (SR) Implant Sustains/supports life Has importance in diagnosing, curing, or treating disease Potential for serious risk to health, safety, or welfare Investigational Device Exemption number assigned by FDA

Non-significant risk (NSR) Does not meet any of the criteria for SR devices

General Controls Companies must register establishments and list

medical devices they market Adhere to Good Manufacturing Practices Label devices as required by labeling regulations

Non-significant Risk (NSR) Class I Subject to general controls only

Elastic bandages, exam gloves

Class II General controls plus special controls identified by FDA

(special labeling requirements, post-market surveillance, performance standards)

Infusion pumps, surgical drapes, powered wheelchairs

Significant Risk (SR) Class III Insufficient information exists for safety and efficacy

Implants, heart valves

To assist Centers for Medicare and Medicaid Services (CMS) in determining coverage FDA categorizes all IDE devices Category A (Experimental):

absolute risk has not been established

Initial questions of safety and efficacy not determined

Category B (Non-experimental/investigational):

Initial questions of safety and efficacy determined OR

Manufacturer has FDA premarket approval or clearance

FDA notifies CMS when sponsor is notified about category

Category A and B Medicare covers “routine care items and services”

furnished in FDA-approved Category A IDE studies if CMS ( or its designated entity) determines that the Medicare coverage IDE study criteria are met Sponsor submits a request to CMS for review and

approval Outline scope and nature of the IDE study

FDA approval letter of the IDE

IDE protocol

IRB approval letter

NCT number

Supporting materials

“Routine care and services refers to items and services that are otherwise generally available to Medicare beneficiaries (that is, a benefit category exists, it is not statutorily excluded, and there is not a national non-coverage decision) that are furnished in a clinical study and that would be otherwise furnished if the beneficiary were not enrolled in a clinical study”

Investigational Devices need charge code assigned CTO/Department notify PHS Revenue integrity Device information: model #, description, price

Clinical Trial information: IDE #, IRB protocol #, study title, PI

If later approved a new charge code must be assigned

If CMS approves coverage petition, complete MGH IDE PMA Notification form each time device is utilized

Documentation must support services provided and reference the clinical trial and device

Prior authorization/Pre-approval required for “research-related” procedures MGH FAU Expedited Authorization Request

Form available in Clinical Trial Billing Guidelines

“Pre-Auth Request - Clinical Letter Attached”

Attach PI letter explaining study

If request approved a “pre-auth” number will be provided (not guarantee of payment)

If request denied or not obtained procedure may be cancelled

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 (see handout) Guides charge direction Template for Timeline in Epic 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 Qualitative assessment only

Identifies what is and is not billable to Medicare Does not apply to other payers Obtain Prior Authorization for study procedures as

needed

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

Must also support the 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

1. Billing Grid

a) Lists items and services included in study and appropriate charge direction

2. Investigational item or service analysis a) IND # or IDE #

b) QCT criteria

c) Sponsor provided items

d) Informed consent statement regarding costs

3. List of study identifying information and documents received

4. NCT and CMS billing information

MCA Billing Grid used as reference for Epic Timeline

PI receives email notification when Epic Timeline created

Process Enroll patient in study and add Timeline

Enter “From Date”

Choose whether to set subsequent dates automatically or not

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 is appropriate to cover research and patient care charges

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

Device Research Policies https://partnershealthcare-

public.sharepoint.com/ClinicalResearch/Requirements_for_an_IDE_for_Human-Subjects_Research.pdf

https://partnershealthcare-public.sharepoint.com/ClinicalResearch/HUD_Checklist.pdf

https://partnershealthcare-public.sharepoint.com/ClinicalResearch/Emergency_Use_of_an_Drug_Biological_Device.pdf

QI Device Accountability Log https://partnershealthcare-

public.sharepoint.com/_layouts/15/WopiFrame.aspx?sourcedoc=%7bD2D55D04-3CCA-49AF-917E-112798F4648A%7d&file=device-accountability-log.dot&action=default

Partners Clinical Trials Office (CTO) Agreements and Clinical Trial Budgets https://partnershealthcare.sharepoint.com/sites/phrmInitiate

/iian/Pages/Industry-Sponsored-Basic-Research-Agreements.aspx

MCA https://partnershealthcare.sharepoint.com/sites/phrmInitiate

/iian/Pages/Medicare-Coverage-Analysis.aspx

Research Management – Research Finance https://partnershealthcare.sharepoint.com/sites/phrmDepartm

ents/prd/rf

Partners IRB Policies https://partnershealthcare.sharepoint.com/sites/phr

mApply/aieipa/irb/Pages/PHRC-Policy-and-Guidance.aspx#9

Partners Quality Improvement https://partnershealthcare.sharepoint.com/sites/phr

mdepartments/poc/qi Medicare National Coverage Decision https://www.cms.gov/Medicare/Coverage/ClinicalTri

alPolicies/downloads/finalnationalcoverage.pdf

MGH Research Compliance Clinical Trial Billing Guidelines http://mghresearch.partners.org/Research_Compliance/HumanS

ubsResearch.aspx

Microstrategy Procedure Picker Email the Help Desk: InsightHelpDesk@partners.org

Department of Clinical Research (formerly CRP) Epic FAQs Tip Sheets Step by step research billing review slides https://hub.partners.org/ecare/ Sign on with Partners username and password