Title: Clinical Research Finance
1Clinical Research Finance
2Clinical Research Billing
3 4Historical Context of Medicare Clinical Trials
5Medicare Hierarchy
6Federal, 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
7Federal, 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 -
8Federal, 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
9Importance of Coverage Analysis
10Importance of Coverage Analysis
11Consequences 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 13NCT
- 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
14V70.7 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
15Q0 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
16When 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
18Medicare - 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
19Items 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 21Coverage 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?
22CRF Coverage Analysis Process
23Is 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
24Is A Coverage Analysis Needed?
25Coverage Analysis
- Important Documents Needed
- Protocol
- Informed Consent
- Contract
- Budget
- Investigator Brochure
- Sponsor Reimbursement Guide
26Coverage 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
27Coverage 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
28Coverage 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
29Device 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
30Device 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?
31Device Trials
32Device 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)
33Drug 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
34Drug 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
35Drug 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
36Drug 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 -
37Drug 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
38Drug 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
39Drug Biologic Trials
40Drug Biologic Trials
- Now it is time for the 2nd part of the Coverage
Analysis the billing grid
41Billing Grid
42Billing 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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49Coverage 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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51Contact CRF With Any Questions?