Post on 24-May-2020
transcript
Clinical Trials Billing Fundamentals
Margaret Munro LyonsResearch Billing Compliance AuditorBWH/BWPO Office of Billing Compliance
January 18, 2019
OBJECTIVES
Identify the two types of clinical trials from a billing perspective:
•Qualifying •Non-qualifying
and how each type affects billing for research services.
Introduce the processes for placing research orders, “linking” them to studies, and directing research charges appropriately in Epic.
Provide an overview of key research billing concepts and the importance of billing for research services correctly and compliantly.
Research Billing Compliance
Getting research billing “right”-
why is this important?
• “Double billing” for research services has been the focus of numerous OIG and DOJ investigations
• Inappropriate billing for research services is bad for our research subjects, for our institution, and for our reputation
Research Billing Compliance
If compliant billing practices are notestablished and followed, research subjects,or their insurance carriers, may be billederroneously for services that were promisedat no cost to them in the informed consent.
Submitting research charges to insurancecarriers inappropriately is not only abreach of compliant research billing, but abreach of our subjects’ privacy that couldimpact their lives adversely in materialways.
GRR!
Oh no…
Research Billing Compliance
Clinical trials billing is complex…
Research Billing Compliance
Some research services areSOMETIMESbillable to insurance
Usual caremay occur in conjunction
with research
Some research services are
NEVERbillable to insurance
Some research services arebillable to insurance
So how do I know who to bill this to…?
1) The agreement with the sponsor
2) The Medicare Coverage Analysis (MCA)
3) The Informed Consent Form
Research Billing Compliance
THE INFORMED CONSENTFORM ALWAYS HAS THEFINAL SAY!
Research Billing Compliance
WHAT TYPE OF CLINICAL TRIAL IS THIS?
The two classifications of clinical trials, per Medicare’s
2007 Clinical Trials Policy
Research Billing Compliance
How research-related charges are directed may depend on the “type” of
clinical trial it is, as defined by CMS.
Research Billing Compliance
A “qualifying” clinical trial contains characteristics which, under PHSinterpretation of CMS guidelines, make it permissible to bill certainassociated, research-related services to subjects or their insurancecarriers.
When a study is deemed “qualifying”, a document called a MedicareCoverage Analysis (MCA) is created by the Partners Clinical TrialsOffice (CTO) to indicate which services may be billed to insurance,which are not billable, and which must be billed to the study fund.
QUALIFYING CLINICAL TRIALS
NON-QUALIFYING CLINICAL TRIALSIf a study is deemed “non-qualifying”, ALL research-specific servicesmust be billed to the study fund.
The majority of BWH clinical trials are deemed “non-qualifying”.
Research Billing Compliance
Research Billing Compliance
Procedure Screening Visit 1
Visit 2
Visit 3
Visit 4
Visit5
Endof
Study
6 MoF/U
Comments
Informed Consent NB Not billable.
Exclusion Criteria F Not Billable.
Physical Exam M M M M M M M MGiven these subjects’ conditions, physical exam is reasonable and necessary at each study visit.
Vitals N/A N/A N/A N/A N/A N/A N/A N/A Not billable; component of the physical exam.
Pregnancy Test NB Research only, bill to study.
TTE NB M M/NBService is research only at screening. TTE is usual care at Visit 3 and EOS (unless terminated early, in which case, the EOS TTE must be billed to the study).
CT Chest, Abdomen M NB MCT chest, abdomen is usual care at Screening and Visit 5. Research only at Visit 3.
CT Neck NB NB NB CT neck is for research purposes only.
Chest X-Ray M M M M NBCXR is usual care at screening and study visits 2, 4, and EOS. Research only at 6 Month F/U Visit.
Tissue Biopsy NB NB NB Research only tissue biopsies. Bill to study.
Study Drug S S S S S SStudy drug promised free from the sponsor in the Informed Consent.
Legend:M = Medicare/insurance bill S = Item supplied by the sponsor F = Forms; not a billable serviceNB = No insurance bill; study bill N/A = Not a billable service
SAMPLE MCA
Research Billing Compliance
HOW DO I KNOW IF A CLINICAL TRIAL IS QUALIFYING?
• Consult the study’s PI,grant manager, post-award administrator,or other staff.
• Consult locally stored
study documents.
• Consult “Agreements”in Insight. If the trialis qualifying, the MCAshould be housedunder “Attachments” inthe “Project Information”section.
Research Billing Compliance
CLINICAL TRIALS BILLING FUNDAMENTALS
Utilizing the Epic research functionalities to direct charges for research-related
services correctly and compliantly
GETTING YOUR TRIAL INTO EPIC
Research Billing Compliance
Research Billing Compliance
EPICEpic is the healthcare system employed by all PHSinstitutions to order, schedule, result, and documentits clinical, revenue and research patient interactions.
To ensure that services associated with clinical trialscan be billed appropriately, all trials involving patientcare must be entered into Epic. This is achieved via asystem interface with Insight, our research portal.
All BWH patient care billing occurs in Epic.
Research Billing Compliance
INSIGHTInsight is the portal where BWH research documents,accounts, study staff information, and other relevantresearch data resides. Before a study can be portedinto Epic, certain parameters must be met in Insight:
1. The protocol must be in an ACTIVE status.2. The protocol must be linked to an ACTIVE study fund.3. The study must involve subject interaction/intervention.4. If the study is federally funded (directly or indirectly), the
fund must include a patient care budget of at least $1.00.
Research Billing Compliance
THE INTERFACEInsight and Epic interface every night at midnight.Once all required criteria has been met in Insight, thestudy will appear in Epic the next morning.
MAGIC!
In Epic, the study will be representeddifferently from what is in Insight. Theinterface joins the IRB protocol numberwith its linked fund number to create anew Epic identifier: The Study Code.
Protocol 2001P001234 + Fund 123456 = Epic Study Code 2001P001234-123456
EPIC RESEARCH FUNCTIONALITIES
Research Billing Compliance
Research Billing Compliance
Once a study has been successfully ported into Epic, there arethree steps to directing research-related charges appropriatelyto either insurance or the study fund:
1. Enrolling the subject to the study2. Linking research-related encounters to the study3. Reviewing research-related charges in the Epic
“Research Billing Review”
My study is in Epic…Now what?
REVIEWING RESEARCH CHARGES
Research Billing Compliance
Before going “out the door”, charges for research-linkedservices are held for review by the study coordinator (orother study team designee), who has the ability to changehow a charge is directed, whether to insurance or to thestudy fund.
• Study-Related – Bill to Study• Study-Related – Bill to Insurance/Patient (used for
insurance-billable charges related to qualifying trials only)• Non-Study Charges• Related to Another Study
USER ACCESS TO STUDIES IN EPIC
Research Billing Compliance
Once a subject is enrolled to a clinical trial in Epic, anyone withview-access to their medical record will be able to see certaininformative details about the study:
1. The study’s title and Epic study code2. The PI and study coordinator’s names3. The subject’s enrollment status and start date
Users who are not members of the study team do not haveaccess to enroll subjects or review/direct charges.
Research Billing Compliance
Who has access to mystudy in Epic?
STUDY TEAM ACCESS
Research Billing Compliance
For a user to be granted access to enroll subjects or reviewand direct research charges, they must:
• Be listed on the study in Insight (which will add them to theEpic study record via the Epic/Insight interface)
• Have completed the required Epic research training
If a member of the study team has met both criteria, butdoes not have access to the research functionalities for thetrial, a ticket should be submitted to the Service Desk.
Research Billing Compliance
WHAT IF I MAKE A MISTAKE?
How to correct a research billing error and who to contact
if you need help.
Research Billing Compliance
HELP?Whether you’re certain that there’s beena research-related billing error, or areconcerned that one may have occurred,please contact me as soon as the questionarises and I will assist you in investigatingthe charge(s).
If a Patient Care Correction is required, the process isinitiated in Insight. I will provide you with the informationand instruction necessary to submit the correction request.
Margaret Munro Lyonsmlyons@bwh.harvard.org
857-307-1577