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					Financial Management of
     Clinical Trials
Presenters: Patricia Conway, University of Rochester
Medical Center
Bethany Martell, University of Chicago Medical Center
Moderator: Cheryl K. Williams, University of Rochester
Presenting financial management of a
  clinical trial from two points of view and
  institutional settings
• Departmental - individual clinical trial set-up
  and management
• Central Office - oversight of several aspects of
  proposed trial
Departmental
• Budget development
• Financial management
• Closeout
Office of Clinical Research – provides
 centralized oversight and
•   Quality assurance and education
•   Regulatory compliance
•   Operations (finance, IT, infrastructure support)
•   IRB
Financial Management of
     Clinical Trials
             Department Perspective
Presenter: Patricia Conway, University of Rochester
                   Medical Center
As research administrator for the
Department of Urology at the University of
Rochester Medical Center, which is a small
department, my experience and role in the
clinical trial area may differ greatly from
yours
I’m responsible for all pre- and post-award
activity for all research grants and clinical
trials. I work closely with our clinical trials
manager, who is responsible for protocol
review, IRB submission, and working
directly with our study patients
Our Sponsored Programs Office is
responsible for approving clinical trial
agreements

Clinical trial agreement is signed off once
protocol and budget are finalized and
attached to the agreement
  Understand the process within your
  institution

• Which departments will be involved?
• Who’s responsible?
• What approvals are required? How long will
  they take?
• How does billing occur?
• Establish communication with your coordinator
  and investigator

• Everyone needs to inform all parties of
  information and events which affect any part of
  the study

• The PI is ultimately responsible for all aspects of
  trial including the budget
Components for success:

– Involvement from the start

– An adequate budget and realistic payment
  schedule

– Careful oversight of ongoing study
Involvement from the start

  • Read the protocol-or at least a synopsis
  • Obtain a general understanding of what
    will take place and the duration
  • Review Schedule of Activities with study
    investigator - which costs are study
    related and which are standard of care ?
Standard of Care vs. Research

 You may not bill patient’s insurance for a
 test, device, or service which is paid for
 by the sponsor
Create a checklist from the schedule
of activities which the investigator
reviews and indicates which items are
study related and which are standard
of care—no guesswork required on
your part!
Example
From the checklist, develop an
adequate budget and a realistic
payment schedule
Consider all costs involved

  • Startup costs
  • Ongoing fixed and variable
    expenses
  • Closeout costs
  • Indirect costs
But first---how to obtain costs to
include in a study budget?

• Personnel costs

  – Review HR system information, or request
    salary and fringe for outside departments from
    administrators
• Non-personnel costs- some examples:

    – Pharmacy- we send protocol copy to obtain
      quote; pharmacy manager responds with
      prices for startup, monthly maintenance fee,
      dispensing, and study closeout, within a week
- Lab tests- we email pricelist form to our
  clinical lab; 1-2 days later they email
  back the current prices –example
  follows:
                     Central Laboratory Research Test Price Request
                                                          Revised: March 15, 2007

                     Send completed request form via email to                   LabSRSS@urmc.rochester.edu.
Requester name:                        Patricia Conway
Title:                                 Research Administrator
Phone number:                          276-3528
Date requested:                        8/7/09

                                   Check any of the top 20 test requests for pricing

       Tests                                                                                Research Price

       Alkaline Phosphate
       ALT
       AST
       Basic Metabolic Profile                                                              $7.69
       (Glucose, Sodium, Potassium, Chloride, CO2, BUN, Creatinine, Calcium, Anion Gap, GFR)
       CBC & Platelet
       CBC, Platelet & Differential
       Creatinine
       Cholesterol
       Comprehensive Metabolic Profile
       (Glucose, Sodium, Potassium, Chloride, CO2, BUN, Creatinine, Calcium, Anion Gap, GFR, Total Protein, Albumin, Globulim, Total Bilirubin,
        AST, ALT, Alk Phos)
       Glucose
       Lipid Profile
       (Cholesterol, Triglycerides, HDL, LDL Calc., Cholesterol/HDL ratio)
       Liver Function Panel                                                                 $13.01
       (Total Protein, Albumin, Globulim, Total Bilirubin, Direct Bilirubin, Indirect Bilirubin, AST, ALT, Alk Phos)
       Protime/INR
       Phosphorus
       Sed Rate
       Serum Pregnancy
       Triglycerides
       Uric Acid
       Urine Pregnancy
       Urinalysis with Microscopic

List any other testing, be specific:

                        Your completed request will be returned via email within 2 business days

Nancy Ziembiec                                                                                         10Aug2009
– Pathology tests-we email Pathology manager
  to obtain cost of Pathology services.
– General Clinical Research Center (NIH funded)
  - we use their services, such as drug injection,
  blood draw, PK samples, EKG etc. if a study
  requires a long clinical visit, since we have
  limited clinic space---patient can have all
  services in one place. We send email request
  for services required; they respond within a day
Startup costs

Startup costs must be nonrefundable…..

  These expenses will be incurred regardless
  of successful study enrollments
What to include in startup costs?
  1. Personnel costs - salary and fringe benefits

     – Effort of investigator and coordinator for IRB
       filings, consent forms, regulatory documents,
       training, pre-screening of charts, study
       initiation visit
     – Administrative effort: study binder creation,
       copying of forms
2. Other fixed startup costs

  - IRB fees – sponsor bills IRB directly for:

  - Initial review

  - Continuing review

  - Amendments
- Consent form translation, if necessary

- Rent of clinical space if required

- Pharmacy startup, maintenance, and closing fees

- Advertising
My experience has been that some of the
larger sponsors have a standard amount
for startup and won’t budge from it---but
always try to negotiate this by a good
justification of costs
Remember…….

Fixed startup expenses will be incurred
whether no patients or 100 patients are
enrolled in the study…so be sure your
budget states that startup costs are
nonrefundable!
Calculate a per-subject fee

The per-subject fee mimics the items on the
Schedule of Activities
  e.g., how much of the study coordinator’s time
  will be needed to review informed consent
  documents with subject? How much time for
  nurse to take vital signs if these are not SOC?
Ongoing Study Costs

  • Specialty equipment used in conduct of
    study – sponsor should pay

  • Lab, pathology, and radiology services

  • Pharmacy dispensing service
Ongoing Study Costs

  • Screen failures
     – Rate typically includes a percentage of
       screening and baseline visit rate (e.g. 75-80%
       of full cost of visit)
     – Rate should be determined based on where
       you anticipate most subjects will screen fail and
       how much work would likely be done prior to
       determining a screen failure
Ongoing Study Costs


• Mid-study withdrawals

• Adverse Event Assessment - cost per SAE
Ongoing Study Costs

  • Participant stipends

  • Binders, copying charges, express mail

  • Data entry
Ongoing Study Costs

• Courier Fees, if necessary
  -   shipping of regulatory documents
  -   shipping specimens
Always review any amendments
which may occur during the life of
the trial---these may affect the
financial situation
Closeout costs

  • Personnel effort for sponsor’s audit

  • Preparation and copying of closeout documents

  • Preparing files for long term storage

  • Cost of maintaining files in storage
Indirect Costs

    Indirects are applied to all direct costs
    except:

•    Pass through costs (IRB fees, direct advertising)
The next component is the payment
 schedule---what process will the
 sponsor use to pay for the costs
 incurred?
Is the payment scheduled clearly
   defined?

•   e.g., sponsor will pay site automatically per
    completed milestones based on case report
    forms or monitoring visits
•   Sponsor agrees to pay for items outside per-
    subject costs (e.g. startup, pharmacy dispensing,
    closeout) upon invoicing
  Avoid these:

• “Upfront” or advance payments for completed
  subjects, especially if the inclusion/exclusion criteria
  for the study are quite limited. This creates the
  illusion of available funds in the budget which must be
  returned to the sponsor if no subjects are enrolled

• “Partial payments” per milestone or completed
  patients---e.g., 20% held back by sponsor until study
  completion
3. Careful oversight of ongoing study

  Now that you’ve created a feasible budget
  and a clearly stated payment schedule—
  you need to manage it!
How to be sure the study is being
charged, not the patient’s insurance?
•   Office visit encounter form-the study name and
    account # is recorded by the nurse – one
    person in our billing office is designated to
    process these

    -   Study coordinator reviews patient visit report
        monthly for accuracy
– For lab and other services:

 Create custom requisition with the study acct. # pre-
 printed which the study nurse sends to clinical lab

    No insurance info is listed; a code specifically for clinical
    studies is substituted for insurance info, which directs billing
    to the clinical trial acct. #



SAMPLE:
Managing study personnel costs

  • Initially, create salary distribution information to
    reflect personnel effort on study which doesn’t
    exceed amount of nonrefundable startup costs

     – Increase once subjects are actually enrolled
  Are subjects actually being enrolled? Be
  sure to review this regularly with your study
  coordinator!

– If no subjects are being enrolled despite coordinator’s
  best efforts, personnel charges should be
  discontinued

– Monitor other expenses to be certain not to
  overspend nonrefundable costs
If subjects have been enrolled:

   • Review completed milestones; create a shared
     database with study coordinator or nurse to
     confirm activities

   • Most sponsors will pay $$$ based on completed
     case report forms, which will trigger payments

   • If we need to bill sponsor, do so on a regular
     basis—usually agreement will stipulate monthly or
     quarterly
To avoid a big surplus or a big deficit---
review study account ledgers on a
monthly or quarterly basis
  STUDY CLOSEOUT

• Study coordinator schedules final monitor visit

• Confirm that sponsor has paid for all
  completed subjects and any invoices ---this
  may require a lot of follow-up

• Confirm that all relevant expenses have been
  charged to the account
• Remove personnel salary distributions from
  study account

• Bill sponsor for closeout costs per budget
Contact info:

Pat Conway
patricia_conway@urmc.rochester.edu
Financial Management of
     Clinical Trials
      Office of Clinical Research Perspective
 Presenter: Bethany Martell, University of Chicago
                   Medical Center
• The University of Chicago Medical Center
   – The Biological Sciences Division (BSD) of the University
   – University of Chicago Hospitals
• Clinical Research is very decentralized
   – Contracts and faculty employment are with the University
   – Clinical services are provided/billed by the Hospitals and
     the Physicians Group
   – Research staff are both University and Hospital employees
   – Conduct and financial management is at the department
     and/or subspecialty level
        The Office of Clinical Research
• A Divisional Office- part of the Dean’s office
• Responsible for:
   –   Quality Assurance and Education
   –   Regulatory Compliance
   –   Operations (Finance, IT, Infrastructure)
   –   Human Subjects Protection (IRB)
• Associate Dean of Clinical Research
• 1 Director and 20 FTEs
       Clinical Research at UofC
• 2500 IRB approved protocols
• 160-200 industry sponsored clinical trials
  initiated annually
• 1100 clinical trials roughly 500 active
• 400-600 research staff
• 400 PIs roughly 275 performing clinical trials
• $5M in clinical charges for research purposes
                  Study Initiation
• Department/PI receives and prepares all required
  documents
• Submission to divisional and university offices
   – Divisional offices- OCR (including IRB)
      • Regulatory and IRB documentation
   – University offices- Univ. Research Admin
      • Contract documents
• Dept/PI responds to University & OCR/IRB comments
• Final IRB approval and contract signed
      Department                Division/Medical Center     University
       Principal
     Investigator


       Department                    Human Subjects
S                                    Protection (IRB)
          Center/
P
                                                             Contract
O        Section
                                                            Negotiations
N       (PI & CRSO,       OCR          Financial and
S         CRC, or                     Administrative           (URA)
O     budget/contracts,           Regulatory Review (OCR)
R        regulatory
         managers)


                                         RadRac

                                      IDS (Pharmacy)




    Central and Concurrent Routing for Study Initiation
 OCR Role in Financial Management
• Provide oversight for both University and
  Hospital interests and concerns
  1. Regulatory oversight
  2. Billing oversight
  3. Reporting mechanisms
  4. Infrastructure management and creation
         1. Regulatory Oversight
• Ensuring we have harmonized documents is the
  foundation of our regulatory compliance plan.
• The OCR is the only office to review ALL of the CT
  financial documents.
• The goal is to make sure they match each other and
  accurately reflect our billing intentions.
• But what does that really mean?
           Regulatory Documents
A. Final protocol
B. Sponsor contract and budget
C. PI reviewed schema/schedule of events
     • Internal designation of RES v. SOC clinical charges
D. Internal budget
E. Informed consent
A. The Protocol
• Overall statement of the research to be conducted.
  The foundation for all other items to be reviewed.
• Details clinical service to be provided along with
  timing/ frequency.

Is every clinical service listed included on both the
   internal budget and sponsor budget as well as the
   schedule of events/schema?
B. The Contract & Sponsor Budget
 •   Medicare secondary payor language
 •   Indemnification language
 •   Injury coverage by sponsor
 •   Provision of drug or device
 •   Does the sponsor budget match the UofC
     budget and schedule of events/Schema?
               Medicare
        Secondary Payor Statutes
• The purpose of the MSP is to ensure Medicare is
  secondarily responsible for payment of medical
  expenses for Medicare beneficiaries who were also
  covered by another type of insurance. The provisions
  of the MSP may be found at 42 U.S.C. §1395y (b).

• However, if a Medicare beneficiary’s injury or illness
  is the responsibility of a third party, Medicare is no
  longer required to pay for treatment. The theory is to
  shift the cost back to the responsible party.
          MSP- Why do we care?
• Many sponsors are willing to pay for services IF they are
  denied by the subjects’ insurance.
• BUT our schema review process requires PIs to
  determine if services are considered medically necessary
  or research related.
• If services are deemed medically necessary then ALL
  payors must pay. If they don’t UCH will contest the
  denial on grounds of medical necessity.
• Consent forms, since usually received from the sponsor
  and pasted into UofC template, sometimes contain
  language they intend to have in the contract regarding
  what and when they will pay for services but when it
  violates MSP, it must be removed.
C. PI Reviewed Schedule of Events
• For harmonization review purposes:
• Review to ensure all items listed in the protocol are
  included on the schedule of events.
• Are all items on the schedule of events included on
  the internal budget?
• Are all items listed as research-related on the schema
  detailed in the costs section of the consent form?
• But, what is the schedule or events or schema
“Schema Review Process”
• Formal documentation by the PI as to which services within a
  protocol are:
   – Medically Necessary and would be performed regardless of trial
     participation
   – Research Related and therefore only needed due to enrollment in trial
• Forms the basis of the internal line item budget
   – Often illustrates clinical services that are not referenced on the
     sponsor budget.
• Can be used to create a billing grid to help ensure charge
  accuracy during the course of the trial.
   – Day 2 CBC is research related, but Day 7 CBC is SOC
     PI Reviewed Schedule of Events
          Distinguishing Charges
• Referred to as the “Schema Review Process”
• Schema Review Memo: The Cover Memo for the PI Reviewed
  Schema which explains how to differentiate between
  standard of care and research related items and also
  documents other budgetary information.
• Schedule of Events: A Diagrammatic representation of the
  sequence of protocol specified events
• Reviewed Schema / Schema: the Schedule of Events on which
  the PI designates services as either:
   – Medically Necessary (SOC- standard of care)
   – Research Related- (RES)
 Sample
 Schema
 Review
  Memo
“Cover Memo”
   The top half of the memo says:
Using the clinical trial protocol, please indicate the tests and/or
procedures that should be paid for by the study/sponsor (a
schedule of events/schema may be helpful), options for
distinction of charges are:
A) they are required for research purposes only as part of this
clinical trial and are not part of the conventional care for a
patient with this medical condition
B) the sponsor is providing compensation for said service and
therefore is not considered billable to a subject and/or their third
party
The top half of the memo: (cont’d)
Per the CMS National Coverage Decision Sept. 2000, only
services considered routine costs of qualifying clinical trials,
are “billable” to Medicare. All coverage rules and payment
requirements (i.e. local coverage decisions) must still be met.
To be “billable” to the subject and/or their third party, all
services considered routine/ conventional care must meet the
following criteria:
 – The services are considered safe and effective based on
    authoritative evidence as generally accepted by the
    medical community.
 – The services are considered medically necessary.
 – The services are not unproven or experimental in nature.
 – Supported by other institutional billing requirements
         Distinguishing Charges
• Routine Care- standard of care or medically
  necessary clinical services
  – Items deemed medically necessary (SOC) are
    billed to insurance in the conventional manner.
• Research Related- only for research data
  and/or paid for by another party (sponsor)
  – Items deemed research related are billed to a
    “research guarantor account” which sends a bill to
    the Dept/PI.
              Reading a Reviewed Schema
      CIRCLED items- To be Paid for by the Sponsor because they are research related.
UNCIRCLED items- Determined by the PI to be Medically Necessary (SOC) and
                                 billable to insurance.
D. Internal Budget
• Details the cost of clinical service required by the
  protocol (and schema) that will be paid for by the
  sponsor.
• Also, lists which services are medically necessary.
• Details other expenses to be paid by the sponsor,
  such as parking, patient compensation, staff and PI
  time, to name a few.
• Does it match the sponsor budget, consent form, and
  schema?
 Are the Clinical Services Billable?
• The PI designates what is RES v. SOC, but the
  next question, is per the National Coverage
  Decision on clinical trials, is the trial
  considered billable?
• Only CMS/Medicare has a blanket policy on
  clinical trial coverage, therefore we defer to
  this guidance.
      Medicare Coverage Analysis- MCA
• A systematic prospective review to determine and/or ensure that
  medically necessary clinical services required by the protocol can be billed
  to Medicare
• Review may include:
     –    Final Study Protocol
     –    Informed Consent Document
     –    Sponsor Agreement (when externally sponsored/funded)
     –    FDA documentation of IND, IDE, or Exemptions (as applicable)
     –    Medicare Policies (LCDs & NCD*s) and Clinical Literature (compendia)
• Variables among institutions in the MCA process
     – The name of the process, if named
     – Centralized or decentralized Processes
     – How detailed the line item review is compared to NCDs and LCDs

•   LCD- Local Coverage Determination and NCD- National Coverage Determination
         CMS Policy on Clinical Trials
• Initial Policy: September 19, 2000, CMS implemented its initial
  Clinical Trial Policy through the National Coverage
  Determination Process.
• Revised Policy: July 9, 2007, CMS issued a reconsideration and
  clarification of the 2000 NCD and renamed it the Medicare
  Clinical Trial Policy
• In general, the content didn’t change. The principles outlined
  in the 2000 policy are still the foundation of clinical trial
  billing.
http://clinicalresearch.bsd.uchicago.edu/faculty_staff/research_finance/documents/n
    ational_coverage.pdf
http://www.cms.hhs.gov/transmittals/downloads/R74NCD.pdf
     National Coverage Decision
• Details the requirements for trials to be
  eligible for coverage of routine costs.
  – 3 Requirements
  – Desirable Characteristics
  – Automatic qualification

• Defines the nature of “Routine Costs” within a
  clinical trial that will be covered.
                 Is the Trial Qualified?
First set of Standards:
    1.    The subject or purpose of the trial must be the evaluation of an item or
          service that falls within a Medicare benefit category (e.g., physicians'
          service, durable medical equipment, diagnostic test) and is not statutorily
          excluded from coverage (e.g., cosmetic surgery, hearing aids).

    2. The trial must not be designed exclusively to test toxicity or disease
          pathophysiology. It must have therapeutic intent.

    3. Trials of therapeutic interventions must enroll patients with diagnosed disease
           rather than healthy volunteers. Trials of diagnostic interventions may enroll
           healthy patients in order to have a proper control group.

•     All three must be fulfilled PLUS meet the following requirements.
          7 Desirable Characteristics
Second Set of Standards:
•   The principal purpose of the trial is to test whether the intervention
    potentially improves the participants' health outcomes;
•   The trial is well-supported by available scientific and medical
    information or it is intended to clarify or establish the health outcomes
    of interventions already in common clinical use;
•   The trial does not unjustifiably duplicate existing studies;
•   The trial design is appropriate to answer the research question being
    asked in the trial;
•    The trial is sponsored by a credible organization or individual capable of
    executing the proposed trial successfully;
•   The trial is in compliance with Federal regulations relating to the
    protection of human subjects; and
•   All aspects of the trial are conducted according to the appropriate
    standards of scientific integrity
     Deemed to be Automatically Qualified
Alternate Standard:
• Clinical trials should have the 7 characteristics; however, some trials, are presumed
    to meet these characteristics and are automatically qualified to receive Medicare
    coverage
• Effective September 19, 2000, clinical trials that are deemed to be automatically
    qualified are:
     1. Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;
     2. Trials supported by centers or cooperative groups that are funded by the NIH, CDC,
         AHRQ, CMS, DOD and VA;
     3. Trials conducted under an investigational new drug application (IND) reviewed by the
         FDA; and
     4. Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be deemed
         automatically qualified until the qualifying criteria are developed and the certification
         process is in place. At that time the principal investigators of these trials must certify
         that the trials meet the qualifying criteria in order to maintain

•   Cooperative Groups are generally deemed to be automatically qualified.
•   Investigator Initiated protocols are often more challenging
  Documenting Study is Qualified
• Formerly IRB Form Q, now built into electronic
  submission system.
• Asks the Principal Investigator to verify that all
  NCD requirements are met.
• The OCR confirms and has processes to
  document the 7 desirable characteristics
  whenever we are the sponsor.
Please Note:
• If a trial is not deemed to be automatically
  qualified (such as investigator- initiated
  protocols), there is no national process for
  documenting that the 7 desirable
  characteristics, therefore internal process for
  formal documentation should be established.
         Routine Costs per the NCD:
• Routine costs of a clinical trial include all items and services that are
  otherwise generally available to Medicare beneficiaries (i.e., there exists a
  benefit category, it is not statutorily excluded, and there is not a national
  noncoverage decision) that are provided in either the experimental or the
  control arms…

• Routine costs in clinical trials include:
    • Items or services that are typically provided absent a clinical trial (e.g.,
        conventional care);
    • Items or services required solely for the provision of the investigational item or
        service (e.g., administration of a noncovered chemotherapeutic agent), the
        clinically appropriate monitoring of the effects of the item or service, or the
        prevention of complications; and
    • Items or services needed for reasonable and necessary care arising from the
        provision of an investigational item or service--in particular, for the diagnosis
        or treatment of complications.
           Routine Costs are NOT:
• the investigational item or service, itself,
• items and services provided solely to satisfy data collection
  and analysis needs and that are not used in the direct clinical
  management of the patient (e.g., monthly CT scans for a
  condition usually requiring only a single scan); and
• items and services customarily provided by the research
  sponsors free of charge for any enrollee in the trial.
• *The Schema Review Cover Memo reference this language*
                 Medicare Coverage Analysis
                      Pre-Award Phase


                                    Budget Manager
                                    Writes draft line                                                                                                                    Return to
                                  item budget based                                                                                                    NO               Department
                                      on schema                   Concurrent Routing
                                                               Documents submitted to
    PI completed                                                                                     OCR reviews all
                                                              Office of Clinical Research                                          All documents
   Schema Review                                                                                      documents for
                                                                1) Budget & Contacts                                                 received?
       Process                                                                                        harmonization
                                                                       documents
                                      Regulatory                   2) IRB documents                                                                                   Accept for
                                       Manager
                                                                                                                                                       YES          Regulatory and
                                     Prepares IRB
                                                                                                                                                                     IRB review
                                      documents




Budget Contract Documents                                                                                                                           Comments sent to
                                                                     OCR Review Process
-PI reviewed Schema                                                                                                                                   department
                                                                       Sponsor Contract-
-PI signed cover memo                                                                                                                                 (change or
                                                              Provision of investigational agent?                                       NO
-Routing Form                                                                                                                                         clarification
                                                                        MSP language?
-Internal Line Item Budget                                                                                                                             requests)                      All documents
                                                                  Injury/indemnification, etc?
-Draft Contract                                                                                                        All documents                                                   reviewed for
                                                                   Informed Consent Form-
-Sponsor Budget                                                                                                        complete and                                                  accuracy prior to
                                                              Costs language matches schema?
                                                                                                                         accurate?                                                       Contract
                                                             Procedures all included on schema?
                                                                                                                                                     Protocol goes to                   Signatures
                                                                      FDA documentation-
         IRB Submission Documents                                       Billable product?                                                              IRB Meeting
                                                                                                                                        YES
         -Submission Pages                                                IRB Form Q-
         -Informed Consent Form                                  Study Deemed or Qualified?
         -Form D (drugs)
         -Form F (devices)
         -Form Q (qualifying)
         -Final Protocol
         -FDA documents




                  Subject Encounter
            Billing Compliance Process                                                                                                                                   Corrections made
                                                                        Both RES and                                                                                      by clinical area
                                                                            SOC?
                                                                           Make 2
                                                                        Appointments
                                                                                                                                UCMC Billing Systems
                                               Number of
        Clinical encounters for                                                                     Services                 Charges reviwed to confirm
                                              appointments
         Research Subjects                                                                          Rendered                 billing requirements met (dx
                                                needed?
                                                                                                                                  codes, modifiers, etc)
                                                                        Only RES or
                                                                          SOC?                                                                                                               Bills Issued to
                                                                          Make 1                                                                                                             selected payer
         We create a separate                                           Appointment
         “insurance” type for research
         subjects which allows us to
         link charges through
         standard clinical operations
         to a research payer.
E. UofC Informed Consent
• The “Costs” section details the financial agreement with
  subjects. Lists items to be provided by the sponsor and which
  will be charged to subject/insurance.
• What the “costs” language says they are financially
  responsible for, is ALL we can charge them, even if completely
  incorrect.
• Other Options- tells us what might be SOC
• Risks/ benefits- tells us if there is therapeutic intent (required
  for billing Medicare per the NCD)
• Does it match the sponsor budget, internal budget, and
  schema?
    How do we check for Harmonization?
•     Before study initiation
     – OCR Pre-review
•     At contract execution best & final offer (BAFO)
     – OCR Review
•     After study enrollment
     – Billing compliance audits- Part of billing oversight
               OCR Pre-review
• All the documents are compared to each other to
  ensure accuracy and consistency.
• If the schema review memo says the sponsor is
  providing the drug or device, does the contract say
  the same?
• If the internal budget says that 3 physical exams are
  SOC and 4 are research, does the sponsor budget
  state they are paying for 4 physicals or 7? (7 would
  mean if we bill insurance according to our schema,
  that we have “double dipped”)
     At Final Contract Execution
• All documents are review again to confirm
  they still match
• Confirm that documents are the same as the
  ones we originally review plus any requested
  changes
• Verify any applicable IRB amendments have
  been submitted
2. Billing Oversight
• The OCR is responsible for:
  – Hospital accounts receivable for research accounts
  – Charge corrections on any research subject
    account
  – Payment processing for research accounts
  – Research billing accuracy audits
         Research Billing Audits
• Using the study documents, a billing grid is
  created, listing all study required RES and SOC
  clinical services
• Using subject lists, all clinical bills (SOC and
  RES) are printed from date of consent to
  current date
• Each is reviewed to confirm only the
  applicable services are included (no RES on an
  SOC bill)
 Additional Billing Responsibilities
• CMS/NGS submissions, specifically
  investigational devices
• Private insurance pre-certification
• Determination of allowable costs, per NCD
• Primary contact for sponsor queries regarding
  reimbursement
3. Reporting
• Annual Research Charge Volume
• Research Subjects on protocol
• Merging of data from disparate systems
  (University v. Hospital)
4. Infrastructure
• IS solutions- interfaces between research
  systems and clinical systems
• Negotiate internal agreements such as
  investigational drug service fees
• Participate on committees and represent
  research enterprise such as with new EMR.
• Troubleshooting common challenges
Moving Forward
• In the OCR, we strive to be well versed in regulations
  and current trends so that we can be a resource for
  research faculty and staff.
• We also function as a point of contact for others in
  the institution for clinical research related matters.
   – Finance
   – Clinical operations
   – Purchasing (investigational devices)
• Questions?


Contact Information:
Bethany Martell
773-834-9799
bmartell@bsd.uchicago.edu

				
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