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

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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

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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

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Importance of Coverage Analysis
10
Importance of Coverage Analysis
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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

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• Important Identifiers

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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

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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
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• Routine Costs
• vs
• Non-Routine Costs

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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

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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

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• Coverage Analysis

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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?

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CRF Coverage Analysis Process
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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

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Is A Coverage Analysis Needed?

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Coverage Analysis

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

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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

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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

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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

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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

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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?

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Device Trials
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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)

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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

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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

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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

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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
•  

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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

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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

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Drug Biologic Trials
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Drug Biologic Trials

• Now it is time for the 2nd part of the Coverage
  Analysis the billing grid

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Billing Grid

• Blank billing grid

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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

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Contact CRF With Any Questions?