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					                                   Office of Billing Compliance
                 Frequently Asked Questions Regarding Research Billing Compliance
                                            10/12/2010

WHAT IS THE DIFFERENCE BETWEEN RESEARCH BILLING COMPLIANCE AND
BILLING COMPLIANCE?

The Office of Billing Compliance at Weill Medical College (WMC) is primarily concerned with
making certain that clinical service billing by faculty providers is done accurately. In general, the
billing, coding and documentation rules and regulations set forth by the Centers for Medicare and
Medicaid Services are used as a standard here, regardless of the type of insurance a patient may
have. All providers and their billing staff are expected to follow this single standard.

Research billing compliance is a component of the WMC Billing Compliance Plan. It deals with
making sure a principal investigator distinguishes standard of care clinical services that are billable
to the patient or their insurance from those services that are not billable to the patient or insurance
because the service is provided for research purposes only or because the service was paid for by
the study sponsor.

Because this initiative is relatively new on a regulatory front, the standards are not as clearly
defined by external regulatory agencies (such as CMS) as other billing rules. The Office of Billing
Compliance, working closely with the Physician Organization Business Office and Research
Administration, has developed some processes and expects these to be used as a single standard
throughout the organization. These include the completion of the Human Research Billing Analysis
Form, flagging research patients in the FLOWCAST* Case Module, scheduling research
appointments using research visit types in FLOWCAST*, and posting all research related clinical
services onto FLOWCAST*.

WHAT IS THE HRBAF?

HRBAF (pronounced Her-Baff) is the acronym for the Human Research Billing Analysis Form.

The need for the HRBAF resulted from Medicare’s Coverage Decision in September of 2000,
which allows researchers to bill for medically necessary clinical services, provided the service will
not be paid for by the study sponsor. Prior to the coverage determination, Medicare would not pay
for any care associated with a research study.

The purpose of the HRBAF is to analyze a research protocol and determine what clinical services
will be rendered to the patient while they are a research subject, who will provide the service, where
the service will be done (i.e. private office, inpatient hospital, radiology imaging center, etc.), at
what frequency, evaluate whether the service is medically necessary standard of care or strictly for
research purposes, and identify services that are paid for by the study sponsor. Ultimately, by
conducting this analysis, a determination is made as to whether or not a particular service is billable
to the patient and their insurance or if the service must be paid by study account funds.




      The IDX billing system has been renamed to “GE Centricity Business Solutions Flowcast”. We refer to the system as
       “FLOWCAST” in this FAQ document.

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                           Office of Billing Compliance
         Frequently Asked Questions Regarding Research Billing Compliance
                                    10/12/2010
HAVE OTHER INSURANCES ADOPTED MEDICARE’S COVERAGE DECISION?

Unless specifically stated in writing by an insurance company to the contrary, it is safe to assume
that Medicare’s Coverage Decision is applicable to all insurances.

WHICH RESEARCH STUDIES REQUIRE A HRBAF?

The HRBAF is required for all IRB approved clinical research studies at WMC.

WHAT IF MY STUDY DOESN’T INVOLVE ANY PATIENT SERVICES?

Some studies do not involve patient services that are defined by a CPT code. The study might be
limited to retrospective data review, or might require that study participants simply complete
questionnaires. A HRBAF is still required.

If a study does not involve actual clinical services, the HRBAF is really easy to complete. Just
follow these five simple steps: 1) complete the top portion for identification of the study, 2)
complete the section labeled “Use This Section If No Billing Required”, 3) complete the “Study
Related Diagnosis Codes/Descriptions” section by listing the primary diagnosis that subjects are
being recruited for (even though they are not getting clinical services), 4) complete the section
labeled “Initial Submission Approvals”, and finally 5) present it to your billing compliance
representative for approval.

In the end, it is the Medical College’s goal to have a HRBAF on file for every clinical research
protocol that has been through the IRB approval process. It is a matter of having one process for all
researchers to follow and, therefore, there is no need to think about when it is or isn’t required. It is
always required.

WHERE CAN I FIND A BLANK HRBAF?

The form is available on the intranet website of the Office of Billing Compliance.
http://intranet.med.cornell.edu/billingcompliance/pdf/HRBAF_form.pdf
or
http://intranet.med.cornell.edu/billingcompliance/pdf/HRBAF_form.xls

CAN SOMEONE WALK ME THROUGH THE COMPLETION OF THE HRBAF?

First of all, instructions for completing the HRBAF are available on the intranet website of the
Office of Billing Compliance.
http://intranet.med.cornell.edu/billingcompliance/pdf/rbaf_instructions.pdf

After reviewing the instructions, if you still need help, contact the billing compliance representative
in your department. http://intranet.med.cornell.edu/billingcompliance/pdf/2_2_dep_com_sta.pdf



      The IDX billing system has been renamed to “GE Centricity Business Solutions Flowcast”. We refer to the system as
       “FLOWCAST” in this FAQ document.

                                                            2 of 7
                            Office of Billing Compliance
          Frequently Asked Questions Regarding Research Billing Compliance
                                     10/12/2010
WHERE DO I SEND THE HRBAF?

The best practice is to submit the approved HRBAF with all required signatures to the IRB with
new protocols and continuing reviews. They will note receipt of the HRBAF and forward it to the
Office of Clinical Trial Administration. If the IRB does not receive the HRBAF when expected, it
will be duly noted as a deficiency in their letter to the Principal Investigator, who will be asked to
complete the HRBAF and submit it.

HOW WILL THE HRBAF BE USED FOR BILLING COMPLIANCE ONCE IT IS
COMPLETED?

The primary use of the completed HRBAF will be for reviewing the accuracy of the billing taking
place for services rendered to research subjects. This will happen in a number of different ways.

The Medical College Billing Compliance Plan requires that every Principal Investigator be
prospectively audited once per year to verify that research billing rules are being followed. When
the PI’s department compliance liaison reviews research subject services posted to FLOWCAST*,
s/he will be verifying that services listed on the HRBAF as billable to the insurance are billed to the
insurance and services listed on the HRBAF as billable to the study account are posted correctly on
FLOWCAST* into the Research Fisc.

The HRBAF can also be used to reconcile the appropriateness of charges being billed to a PI’s
study account. When an invoice from the hospital or another department is received and its lists a
service, the person with responsibility for approving the invoice can look at the HRBAF to verify
that it was a protocol service designated as billable to the study account.

DOES ANYONE ELSE USE THE HRBAF?

The HRBAF has been a useful tool in preparing study budgets. The Office of Clinical Trial
Administration Budget and Billing staff frequently refer to the HRBAF when conducting a
feasibility analysis of a study budget.

WHO CONDUCTS RESEARCH BILLING COMPLIANCE AUDITS?

Every department has an appointed billing compliance liaison and a billing compliance physician
leader. Some departments have additional billing compliance staff. It is the department compliance
teams that are responsible for coordinating the research billing compliance audit activities. The
audit results are shared with the PI. If there are significant audit findings that require corrective
action on the part of the PI or their research staff, it is likely that a re-audit will be conducted after
the audit feedback to make sure that all potential problem areas have been resolved and are not
recurring.




      The IDX billing system has been renamed to “GE Centricity Business Solutions Flowcast”. We refer to the system as
       “FLOWCAST” in this FAQ document.

                                                            3 of 7
                           Office of Billing Compliance
         Frequently Asked Questions Regarding Research Billing Compliance
                                    10/12/2010
WHAT WOULD BE CONSIDERED A RESEARCH BILLING ERROR AND REQUIRE
CORRECTIVE ACTION?

Examples of research billing compliance errors can include any of the following: service billed to
patient/insurance but should have been billed to the study; service billed to the study but should
have been billed to the patient/insurance; service billed to patient insurance but it was not posted
with the QA or QV modifier; diagnosis code V70.7 was missing or used in error; research service
was documented but not billed.

WHAT IS A QA AND QV MODIFIER?

The QV and QA modifiers are procedure code modifiers used to identify clinical trial services. The
QV modifier is defined as, “Item or service provided as routine care in a Medicare covered clinical
trial”. When patients or their insurance are being billed for standard of care services provided
during the clinical trial, the physician must provide the QV modifier in addition to the CPT code
being submitted for billing.

The QA modifier is specific to research billing for studies involving a FDA approved
investigational device. Modifier QA is used to identify claims for investigational devices and/or
service incident to the use of such devices. When billing with modifier QA, the biller must include
the IDE number on the claim form submitted for payment.

WHEN IS DIAGNOSIS CODE V70.7 USED?

The easy answer is, whenever the QV modifier or QA modifier is used, the diagnosis codes for the
service should include V70.7 in the secondary or lower diagnosis code position. (For patients
participating in a clinical trial as part of a control group, the V70.7 is used as the primary
diagnosis.) The V70.7 diagnosis code represents “Examination of participant in clinical trial”. The
QV or QA modifier and V70.7 diagnosis code used together on a claim form to Medicare will serve
as your attestation that the service meets the coverage criteria (i.e., was furnished to a beneficiary
who is participating in a qualifying clinical trial and represents routine patient care, including
complications associated with qualifying trial participation).

SHOULD I USE THE QV OR QA MODIFIER AND V70.7 MODIFIER FOR NON-
MEDICARE?

Yes. The QV or QA modifier may be suppressed from appearing on claims to non-Medicare payers
but attaching these codes at the time of charge entry will help with future identification of services
that were routine care provided to patients enrolled in research studies. These codes will be
valuable for future reporting you may wish to do utilizing the FLOWCAST* system.




      The IDX billing system has been renamed to “GE Centricity Business Solutions Flowcast”. We refer to the system as
       “FLOWCAST” in this FAQ document.

                                                            4 of 7
                            Office of Billing Compliance
          Frequently Asked Questions Regarding Research Billing Compliance
                                     10/12/2010
WHAT INFORMATION GOES INTO THE FLOWCAST* CASE MODULE TO FLAG
RESEARCH SUBJECTS?

Before a research case can be created for patients participating in a particular study, there is certain
information that must be built into the protocol dictionary and when referenced in the case module
will pre-populate some of the patient fields. The information that is set up in a protocol dictionary
is the PI first and last name, research grant account number, protocol number, short title (from
HRBAF), contact name, department designee, plan code from the hospital if required, and the
department name. When a case is associated with a patient record, the above information is
associated via the protocol number selection from a drop down field, and the additional information
that is added is the patient’s start date in the protocol and a comment indicating from whom a copy
of the HRBAF could be obtained. Completing a research case screen for a patient generally
requires less than one minute of time.

WHO IS RESPONSIBLE FOR ENTERING THE FLOWCAST* RESEARCH CASE INFO?

The responsibility for creating a research case on FLOWCAST* varies by department. Generally,
there is one designated individual in each department who is responsible for submitting information
that is required to establish a protocol in the protocol dictionary. Then, the actual patient case entry
might be centralized to one designated staff member or might be the responsibility of the research
coordinator(s) for the PI. Check with your department administrator or department compliance
liaison to find out how it is handled in your department.

WHEN IS A CASE REQUIRED?

Patient research cases are only required if there is patient enrollment and if the research will involve
clinical services with will result in billing to either the patient, their insurance, or the internal
research account. If a study is simply for data analysis, retrospective image review, or involves
patient interviews/questionnaires and no clinical services, then a case would not be required.

HOW WILL THE FLOWCAST* CASE MODULE HELP MANAGE THE RESEARCH
BILLING COMPLIANCE PROCESS?

The FLOWCAST* case module will be used as a flag to indicate that the patient is involved in a
research study. This flag is viewable by staff who schedule appointments and post charges into
FLOWCAST* and can lead to verification that the charge is correctly posted as billable to
insurance or billable to the grant account. Research patients flagged in the FLOWCAST* case
module can be automatically flagged in EPIC and providers can be reminded when ordering
services or closing an encounter that the patient is a research subject to help them indicate the
appropriate billing mechanism—insurance or grant account. The case module can also facilitate the
periodic research billing audits that are required by the Medical College.

The case module can also be used for approving invoices submitted for payment to come from the
grant account. When a PI’s staff member receives the invoice for a service, they can quickly look

      The IDX billing system has been renamed to “GE Centricity Business Solutions Flowcast”. We refer to the system as
       “FLOWCAST” in this FAQ document.

                                                            5 of 7
                                       Office of Billing Compliance
                 Frequently Asked Questions Regarding Research Billing Compliance
                                                10/12/2010
to see if the patient has a case for the study and whether or not it was active on the date of service
listed on the invoice. Essentially, the case module is a central database of enrolled research
patients.

ARE THERE ANY SPECIAL DOCUMENTATION RULES WHEN ROUTINE CARE IS
PROVIDED TO PATIENTS ENROLLED IN CLINICAL TRIALS?

The trial name, sponsor’s name and protocol number should be readily available in the patient’s
medical record when clinical services are deemed routine care and will be billed to the patient or
their insurance.

If Medicare initiates a medical review, a copy of the signed informed consent must be readily
supplied upon request. Additionally, the billing provider must submit a detailed itemization of items
and services billed as routine costs in the clinical trial. These are best reported out of the
FLOWCAST* billing system.

WHAT ARE THE P.O. RULES FOR ENTERING RESEARCH SERVICES INTO
FLOWCAST* WHEN THE STUDY ACCOUNT WILL BE BILLED AND NOT THE
PATIENT OR THEIR INSURANCE?

The P.O. requires that all clinical services be posted into FLOWCAST*. When a Research Account
is going to be billed, the charges are posted into a research financial class (FISC=500/RSH).
Statements to patients are not created for any service posted to FISC 500/RSH. You should also be
aware that the Research Accounting Office has a form called the “Grant/Research Transfer Request
Form” that is to be used for requesting payments for charges posted to the Research FISC from a
grant account. The form requires that invoices from FLOWCAST* be attached to the form. A
signature from the PI must be obtained to authorize the payment from their grant account. In
addition, this form requires department approval by the administrator or their designee. The signed
form and attachments will then be sent to the Research Accounting Office for processing of the
payment from the grant account to be posted against the billed charge(s) on FLOWCAST*.

The important point to remember is that services rendered must be posted to FLOWCAST* and the
corresponding payment from the research account must be reflected.

The Office of Billing Compliance and the Physician Organization Business Office are reviewing
this process and hope to recommend a more streamlined process in the near future.




      The IDX billing system has been renamed to “GE Centricity Business Solutions Flowcast”. We refer to the system as
       “FLOWCAST” in this FAQ document.

                                                            6 of 7
                           Office of Billing Compliance
         Frequently Asked Questions Regarding Research Billing Compliance
                                    10/12/2010
WHO ARE THE RESEARCH BILLING COMPLIANCE CONTACTS AT NYP?

This question was presented to the NYP Compliance Office. Their response is as follows:

       We do not have "research billing" department but these other areas should be able to
       investigate / respond to problems or concerns:

       Richard Hlenski
       Director of Finance, Office of Clinical Trials
       rhlenski@nyp.org
       305-4596

       Roseanne Hagan
       Director, Patient Financial Services
       rhagan@nyp.org
       297-4430

       Karen Pagliaro
       Director, Corporate Compliance
       pagliar@nyp.org
       746-1327

MY QUESTION ABOUT RESEARCH BILLING COMPLIANCE WAS NOT ANSWERED.
WHO CAN I CALL FOR FURTHER ASSISTANCE?

Call the Office of Billing Compliance -- 212-746-2430 or 212-746-0145.




      The IDX billing system has been renamed to “GE Centricity Business Solutions Flowcast”. We refer to the system as
       “FLOWCAST” in this FAQ document.

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