Coverage Analysis
Clinical Research Finance
Protocol/IRB
Submission
Charge
Entry/Billing
Coverage
Analysis
Clinical
Research
Billing
Patient
Service
Procedure
Contract
Budget
Patient
Registration
Schedule
Contract
Execution
Setup
History and
Background
Historical Context of Medicare &
Clinical Trials
1994
1995
June 2000
Sept 2000
July 2007
• Gov’t admits
Medicare
guidelines
need clarity
• Approval of
investigationa
l devices
• CMS covers
routine care
services
• Medicare
covers
routine cost
of qualifying
clinical trials
• Current CTP
implemented
Medicare Hierarchy
National Level
(CMS)
National
Coverage
Determinations
(NCD’s)
Medicare
Regional
Medicare
Administrative
Contractors
(MAC’s )
-15 Regions
Local Coverage
Determinations
(LCD’s)
Federal, State, & Local Regulations
• CR 8401/CMS transmittal (2758)
– http://cms.gov/Regulations-andGuidance/Guidance/Transmittals/Downloads/R2758C
P.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-andGuidance/Guidance/Manuals/Internet-Only-ManualsIOMs-Items/CMS012673.html
Federal, State, & Local Regulations
• IND Exemption 21 CFR 312.2
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevel
opedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplica
tion/default.htm
• Affordable Care Act
–
–
http://www.hhs.gov/healthcare/rights/law/index.html
Section 2709
• State Regulations
– www.cancer.gov/clinicaltrials/learningabout/payingfor/laws/tx
– www.legis.state.tx.us/tlodocs/81R/billtext.html/SB00039F.htm
– Texas Senate Bill 39 (Ch. 719)
http://www.legis.state.tx.us/tlodocs/81R/billtext/html/SB00039F.htm
Federal, State, & Local Regulations
• False Claims Act
- http://downloads.cms.gov/cmsgov/archiveddownloads/S
MDL/downloads/SMD032207Att2.pdf
• The Anti-Kickback Statute
- http://www.gpo.gov/fdsys/pkg/USCODE2010title42/pdf/
USCODE2010title42chap7subchapXI-partA-sec1320a7b.pdf
• Stark Law
- http://www.gpo.gov/fdsys/pkg/USCODE-2010title42/pdf/USCODE-2010-title42-chap7-subchapXVIIIpartE-sec1395nn.pdf
Importance of Coverage
Analysis
Assist in
identifying
financial
responsibility
Research
compliance
process
Tool to ensure
compliant
claims
processing
Early
Detection of
Items &
Services Not
Covered
Coverage
Analysis
Trust of
Sponsors/
CROs
Increased
Revenue
Opportunities
Comprehensive
analysis of
related
documents
Importance of Coverage Analysis
Increased
Governmental
Scrutiny
Cost to
Implement
Corrective
Action
Loss of Trust
Under Billing
Loss of
Governmental
Funding
Criminal
Penalties
Civil Fines
Consequences
Cost
Associated
with
Investigation
•
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 researcher’s 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
Important Identifiers
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 8digit number (for example, NCT00000419)
• Used to identify all items and services provided to
beneficiaries in a clinical trial
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
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
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
Routine Costs
vs
Non-Routine Costs
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
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
Coverage Analysis
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?
CRF Coverage Analysis Process
CRF reviews/approves
justification
CRF emails contract
specialist, PI, dept
contact, will approval
notice
Submit to CRF for
Review
Submit the completed
grid for review
CRF will submit
necessary HEAT tickets
(EG, NCT, Study
Schedule)
CRF will notify
department personnel
to complete qualifying
questions
Department prepares
coverage analysis
billing grid
Fully executed contract
is processed and
clinical trial can begin
Billing Risk
Questionnaire (iRIS or
Email)
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 CRF’s website at
http://www.uth.edu/dotAsset/2b1cf56a-ee5c-4292-bee6284f674490ab.pdf
Is A Coverage Analysis Needed?
•
Coverage Analysis
• Important Documents Needed
– Protocol
– Informed Consent
– Contract
– Budget
– Investigator Brochure
– Sponsor Reimbursement Guide
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
Coverage Analysis
•
Contract
–
•
•
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 what has been agreed upon that the sponsor will pay for
Provides details on investigational product
Sponsor Reimbursement Guide
–
Provides guidance on which services are routine care
–
Provides guidance on most accurate billing codes (CPT) to use for maximum
reimbursement
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
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 preapproval
– www.novitas-solutions.com
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?
Device Trials
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)
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
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
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
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
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
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
Drug & Biologic Trials
Drug & Biologic Trials
• Now it is time for the 2nd part of the
Coverage Analysis – the billing grid
Billing Grid
• Blank billing grid
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
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
Contact CRF With Any
Questions?