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Clinical Research Finance

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CPT / CDM codes. Modifiers. Study schedule (i.e. baseline, week 2, follow-up month 24, etc ) Place a R for research and the sponsor will be billed or ... – PowerPoint PPT presentation

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Title: Clinical Research Finance


1
Clinical Research Finance
  • Coverage Analysis

2
Clinical Research Billing
3
  • History and
  • Background

4
Historical Context of Medicare Clinical Trials
5
Medicare Hierarchy
6
Federal, State, Local Regulations
  • CR 8401/CMS transmittal (2758)
  • http//cms.gov/Regulations-and-Guidance/Guidance/T
    ransmittals/Downloads/R2758CP.pdf.
  • Clinical Trial Policy (CTP or NCD 310.1)
  • www.cms.gov/Medicare/Coverage /Clinical Trial
    Policy/index.html
  • Medicare Benefit Policy Manual, Ch. 14 , Ch.15,
    Ch.32
  • http//www.cms.gov/Regulations-and-Guidance/Guidan
    ce/Manuals/Internet-Only-Manuals-IOMs-Items/CMS012
    673.html

7
Federal, State, Local Regulations
  • IND Exemption 21 CFR 312.2 http//www.fda.gov/Drug
    s/DevelopmentApprovalProcess/HowDrugsareDevelopeda
    ndApproved/ApprovalApplications/InvestigationalNew
    DrugINDApplication/default.htm
  • Affordable Care Act
  • http//www.hhs.gov/healthcare/rights/law/index.htm
    l
  • Section 2709
  • State Regulations
  • www.cancer.gov/clinicaltrials/learningabout/paying
    for/laws/tx
  • www.legis.state.tx.us/tlodocs/81R/billtext.html/SB
    00039F.htm
  • Texas Senate Bill 39 (Ch. 719) http//www.legis.st
    ate.tx.us/tlodocs/81R/billtext/html/SB00039F.htm

8
Federal, State, Local Regulations
  • False Claims Act
  • http//downloads.cms.gov/cmsgov/archiveddownloads/
    SMDL/downloads/SMD032207Att2.pdf
  • The Anti-Kickback Statute
  • http//www.gpo.gov/fdsys/pkg/USCODE2010title42/pdf
    /USCODE2010title42chap7subchapXI-partA-sec1320a-7b
    .pdf
  • Stark Law
  • http//www.gpo.gov/fdsys/pkg/USCODE-2010-title42/p
    df/USCODE-2010-title42-chap7-subchapXVIII-partE-se
    c1395nn.pdf

9
Importance of Coverage Analysis
10
Importance of Coverage Analysis
11
Consequences Settlements/Fines
  • Rush University Settlement
  • 1Million
  • Improperly billed Medicare attributed to the
    absence of synchronization of the Medicare rules,
    the compensation arrangements with the sponsor,
    the financial discussion in the Informed Consent
  • University of Alabama at Birmingham
  • 3.39Million
  • Falsely billed Medicare for researchers time
    spent on patient care when no patients had been
    seen
  • Falsely billed Medicare for clinical research
    trials that were also billed to the sponsor of
    the research grant
  • Emory University
  • 1.5Million
  • Falsely billing Medicare Medicaid
  • Sponsor agreed to pay for services which were not
    invoiced by Emory

12
  • Important Identifiers

13
NCT
  • Unique identification code given to each clinical
    study registered on ClinicalTrials.gov
    (www.clinicaltrials.gov)
  • The format is the letters "NCT" followed by an
    8-digit number (for example, NCT00000419)
  • Used to identify all items and services provided
    to beneficiaries in a clinical trial

14
V70.7 Diagnosis Code
  • V70.7 is an ICD-9 diagnosis code that states the
    patient is a participant in a clinical trial
  • V70.7 must be applied to all charging documents
    where services will be billed out to Medicare/
    3rd party payers

15
Q0 Q1
  • Modifier Q0 Investigational clinical service
    provided in a clinical research study that is in
    an approved clinical research study.
  • Use Q0 to designate the item under investigation
    in the trial/study
  • Modifier Q1 Routine clinical service provided in
    a clinical research study that is in an approved
    clinical research study.
  • Use Q1 to identify routine services provided in
    the trial/study

16
When to use the Q Modifiers
Type of Claim Q1 or Q0 Needed?
Inpatient No (Use V70.7 Condition Code 30 only)
Outpatient Yes
On the line for an item/service that was provided as part of a clinical trial, but is included on a claim with other non-study related care Yes
One the line item for items/services that are not related to the clinical study, but are part of a claim that does include items/services that are part of a research study No
17
  • Routine Costs
  • vs
  • Non-Routine Costs

18
Medicare - Routine Cost
  • Items or services that are typically provided
    when the patient is not on a clinical trial
  • Items or services required for the provision of
    the investigational item or service
  • The clinically appropriate monitoring of the
    effects of the item or service, or the prevention
  • Items or services needed for reasonable and
    necessary care arising from the provisions of an
    investigational item or service in particular,
    for the diagnosis or treatment of complications

19
Items NOT Routine
  • The investigational item/service unless it is
    already covered outside of the clinical trial
  • Items/Services provided solely for research
    purposes
  • Items/Services solely to determine eligibility
  • Items/Services provided/paid by the Sponsor
  • Items promised free in the informed consent
  • Items that are excluded from typical coverage

20
  • Coverage Analysis

21
Coverage Analysis
  • What is the process here at UT Health?
  • Do I need a Coverage Analysis?
  • What is a Billing Risk Form?
  • If I need a Coverage Analysis, what do I need to
    do?

22
CRF Coverage Analysis Process
23
Is A Coverage Analysis Needed?
  • Not all trials will need a Coverage Analysis
  • Trials that involve Routine Costs, commonly
    referred to as Standard of Care, will require a
    Coverage Analysis
  • No direct patient billable charges (i.e.
    x-rays) no Coverage Analysis
  • A checklist has been created to help you in
    answering this question and can be found on the
    CRFs website at http//www.uth.edu/dotAsset/2b1cf
    56a-ee5c-4292-bee6-284f674490ab.pdf

24
Is A Coverage Analysis Needed?

25
Coverage Analysis
  • Important Documents Needed
  • Protocol
  • Informed Consent
  • Contract
  • Budget
  • Investigator Brochure
  • Sponsor Reimbursement Guide

26
Coverage Analysis
  • Protocol
  • Provides the details of the study and the study
    procedures
  • Provides a schedule of events table
  • May provide details of what is routine and what
    is not
  • Informed Consent
  • Provides details of the study in a condensed
    manner
  • Provides description of the study procedures
  • Provides details of what the patient financial
    responsibilities will be

27
Coverage Analysis
  • Contract
  • Provides what has been agreed upon that the
    sponsor will pay for
  • Budget
  • Provides a detailed breakdown of the services
    conducted for the study
  • Provides a detailed breakdown of who will cover
    the services conducted for the study
  • Investigator Brochure
  • Provides details on investigational product
  • Sponsor Reimbursement Guide
  • Provides guidance on which services are routine
    care

28
Coverage Analysis
  • After you have reviewed all the pertinent
    documents available, a Coverage Analysis can be
    started
  • A Coverage Analysis has 2 parts
  • Approval / Qualifying Determination
  • Billing Grid

29
Device Trials
  • Device trials fall under the device regulations
  • Services must be pre-approved by CMS
  • Medicare Contractor/ Fiscal Intermediary for
    Texas is Novitas
  • Submit a packet to CMS to obtain this
    pre-approval
  • www.novitas-solutions.com

30
Device Trials
  • Questions to ask with device trials
  • Is it an implantable device?
  • What type of device is it? PMA, HUD, 510K, IDE?
  • If an IDE, what category is it? A or B?
  • Is the device provided for free by the sponsor or
    will it be billed to the patient/ patient
    insurer?
  • Has it been submitted to CMS for pre-approval?
  • Has the Memorial Hermann Hospital Device
    Checklist been completed?

31
Device Trials
32
Device Trials
  • Now it is time for the 2nd part of the Coverage
    Analysis the billing grid
  • (An example billing grid will be discussed in
    further detail later in this presentation)

33
Drug Biologic Trials
  • As stated in the history section of the
    presentation, drug and biologic trials fall under
    the Clinical Trial Policy described in the
    National Coverage Determination (NCD) 310.1

34
Drug Biologic Trials
  • A drug and biologic trial must be considered a
    Qualifying Clinical Trial (QCT) in order to be
    eligible for billing out routine costs in the
    trial
  • Certain requirements set forth by CMS in the NCD
    must be met in order for the trial to be
    considered a QCT

35
Drug Biologic Trials
  • The requirements are
  • The subject or purpose of the trial is the
    evaluation of an item or service that falls
    within a Medicare benefit category (e.g.,
    physicians' service, durable medical equipment,
    or diagnostic test) and is not statutorily
    excluded from coverage (e.g., cosmetic surgery,
    hearing aids)
  • The trial has therapeutic intent (i.e., the trial
    is not designed exclusively to test toxicity or
    disease path physiology
  • For a trial of a therapeutic intervention, the
    trial must enroll patients with diagnosed disease
    rather than healthy volunteers

36
Drug Biologic Trials
  • Additionally, the trial must also be considered
    Deemed
  • The trial is considered to be a deemed study if
  • Funded by National Institutes of Health (NIH),
    Centers for Disease Control (CDC), Agency for
    Health Care Research and Quality (AHRQ), CMS,
    Department of Defense (DOD), and Veteran's
    Administration (VA)
  • Supported by Kenneth Norris Jr. Comprehensive
    Cancer Center
  • Conducted under an investigational new drug
    application (IND) reviewed by the FDA
  • Or exempt from having an IND under 21 CFR
    312.2(b)(1) because all of the following criteria
    are met with respect to investigation
  •  

37
Drug Biologic Trials
  • If you can answer YES to all 4 questions, then
    you have a QCT
  • Which means routine costs are eligible to be
    billed out to Medicare and/or 3rd party payers

38
Drug Biologic Trials
  • If you answer NO to any of the 4 questions,
    then you have a NON-QCT
  • Which means routine costs are not eligible to be
    billed out to Medicare and/or 3rd party payers
    and everything must be billed to and paid by the
    sponsor

39
Drug Biologic Trials
40
Drug Biologic Trials
  • Now it is time for the 2nd part of the Coverage
    Analysis the billing grid

41
Billing Grid
  • Blank billing grid

42
Billing Grid
  • Fill in the following fields
  • Items services
  • CPT / CDM codes
  • Modifiers
  • Study schedule (i.e. baseline, week 2,
    follow-up month 24, etc)
  • Place a R for research and the sponsor will be
    billed or SOC for the routine costs that will
    be billed to Medicare/3rd party payer at the time
    points services will be conducted
  • For all services marked SOC provide
    justification as to why it is considered as
    routine care

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Coverage Analysis
  • After the Coverage Analysis is complete, you must
    submit it to the Clinical Research Finance (CRF)
    Team for review
  • Per new policies and procedures, contracts will
    not be executed unless a Coverage Analysis has
    been submitted to and reviewed by CRF

50
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