Clinical Trials Billing Fundamentals · 2020-02-26 · types of clinical trials from a billing...

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


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…


Clinical trials billing is complex…


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


THE INFORMED CONSENTFORM ALWAYS HAS THEFINAL SAY!


WHAT TYPE OF CLINICAL TRIAL IS THIS?

The two classifications of clinical trials, per Medicare’s

2007 Clinical Trials Policy


How research-related charges are directed may depend on the “type” of

clinical trial it is, as defined by CMS.


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”.



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


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.


CLINICAL TRIALS BILLING FUNDAMENTALS

Utilizing the Epic research functionalities to direct charges for research-related

services correctly and compliantly

GETTING YOUR TRIAL INTO EPIC



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.


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.


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



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


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


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.


Who has access to mystudy in Epic?

STUDY TEAM ACCESS


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.


WHAT IF I MAKE A MISTAKE?

How to correct a research billing error and who to contact

if you need help.


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 [email protected]

857-307-1577

Clinical Trials Billing Fundamentals · 2020-02-26 · types of clinical trials from a billing...

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