clinical research finance
DESCRIPTION
Clinical Research Finance. Coverage Analysis. Clinical Research Billing. History and Background. Historical Context of Medicare & Clinical Trials. Medicare Hierarchy. Federal, State, & Local Regulations. CR 8401/CMS transmittal (2758) - PowerPoint PPT PresentationTRANSCRIPT
Clinical Research Finance
Coverage Analysis
Protocol/IRB Submission
Coverage Analysis
Contract Budget
Contract Execution
Setup
Patient Registration
Schedule
Patient Service
Procedure
Charge Entry/Billing
Clinical Research
Billing
History and Background
1994• Gov’t admits
Medicare guidelines need clarity
1995• Approval of
investigational devices
June 2000• CMS covers
routine care services
Sept 2000• Medicare
covers routine cost of qualifying clinical trials
July 2007 • Current CTP
implemented
Historical Context of Medicare & Clinical Trials
Medicare Hierarchy
Medicare
National Level (CMS)
National Coverage
Determinations (NCD’s)
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-and-Guidance/Guidance/Transmittals/Downloads/R2758CP.pdf.
• Clinical Trial Policy (CTP or NCD 310.1)– www.cms.gov/Medicare/Coverage /Clinical Trial P
olicy/index.html• Medicare Benefit Policy Manual, Ch. 14 , Ch.15, &
Ch.32– http://
www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs-Items/CMS012673.html
Federal, State, & Local Regulations
• IND Exemption 21 CFR 312.2 http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/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/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/pdf/USCODE-2010-title42-chap7-subchapXVIII-partE-sec1395nn.pdf
Importance of Coverage Analysis
Coverage Analysis
Assist in identifying financial
responsibility
Research compliance
process
Comprehensive analysis of
related documents
Increased Revenue
Opportunities
Trust of Sponsors/
CROs
Early Detection of
Items & Services Not
Covered
Tool to ensure
compliant claims
processing
Importance of Coverage Analysis
ConsequencesCivil Fines
Criminal Penalties
Increased Governmental
Scrutiny
Cost to Implement Corrective
Action
Loss of Trust
Under Billing
Loss of Governmental
Funding
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 8-digit 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
Billing Risk Questionnaire (iRIS or Email)
Submit to CRF for Review
CRF will notify department personnel to complete qualifying
questions
Department prepares coverage analysis billing grid
Submit the completed grid
for review
CRF reviews/approve
s justification
CRF emails contract specialist, PI, dept
contact, will approval notice
CRF will submit necessary HEAT
tickets (EG, NCT, Study Schedule)
Fully executed contract is processed and clinical
trial can begin
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-bee6-284f674490ab.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
– 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
– 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 pre-approval– 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?