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
![Page 1: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/1.jpg)
Clinical Research Finance
Coverage Analysis
![Page 2: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/2.jpg)
Protocol/IRB Submission
Coverage Analysis
Contract Budget
Contract Execution
Setup
Patient Registration
Schedule
Patient Service
Procedure
Charge Entry/Billing
Clinical Research
Billing
![Page 3: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/3.jpg)
History and Background
![Page 4: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/4.jpg)
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
![Page 5: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/5.jpg)
Medicare Hierarchy
Medicare
National Level (CMS)
National Coverage
Determinations (NCD’s)
Regional
Medicare Administrative
Contractors (MAC’s )
-15 Regions
Local Coverage Determinations
(LCD’s)
![Page 6: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/6.jpg)
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
![Page 7: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/7.jpg)
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
![Page 8: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/8.jpg)
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
![Page 9: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/9.jpg)
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
![Page 10: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/10.jpg)
Importance of Coverage Analysis
ConsequencesCivil Fines
Criminal Penalties
Increased Governmenta
l Scrutiny
Cost to Implement Corrective
Action
Loss of Trust
Under Billing
Loss of Governmenta
l Funding
Cost Associated
with Investigation
![Page 11: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/11.jpg)
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
![Page 12: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/12.jpg)
Important Identifiers
![Page 13: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/13.jpg)
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
![Page 14: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/14.jpg)
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
![Page 15: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/15.jpg)
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
![Page 16: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/16.jpg)
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
![Page 17: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/17.jpg)
Routine Costs vs
Non-Routine Costs
![Page 18: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/18.jpg)
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
![Page 19: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/19.jpg)
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
![Page 20: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/20.jpg)
Coverage Analysis
![Page 21: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/21.jpg)
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?
![Page 22: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/22.jpg)
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/approves
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
![Page 23: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/23.jpg)
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
![Page 24: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/24.jpg)
Is A Coverage Analysis Needed?•
![Page 25: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/25.jpg)
Coverage Analysis• Important Documents Needed
– Protocol
– Informed Consent
– Contract
– Budget
– Investigator Brochure
– Sponsor Reimbursement Guide
![Page 26: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/26.jpg)
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
![Page 27: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/27.jpg)
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
![Page 28: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/28.jpg)
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
![Page 29: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/29.jpg)
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
![Page 30: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/30.jpg)
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?
![Page 31: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/31.jpg)
Device Trials
![Page 32: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/32.jpg)
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)
![Page 33: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/33.jpg)
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
![Page 34: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/34.jpg)
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
![Page 35: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/35.jpg)
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
![Page 36: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/36.jpg)
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
![Page 37: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/37.jpg)
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
![Page 38: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/38.jpg)
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
![Page 39: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/39.jpg)
Drug & Biologic Trials
![Page 40: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/40.jpg)
Drug & Biologic Trials
• Now it is time for the 2nd part of the Coverage Analysis – the billing grid
![Page 41: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/41.jpg)
Billing Grid• Blank billing grid
![Page 42: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/42.jpg)
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
![Page 43: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/43.jpg)
![Page 44: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/44.jpg)
![Page 45: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/45.jpg)
![Page 46: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/46.jpg)
![Page 47: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/47.jpg)
![Page 48: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/48.jpg)
![Page 49: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/49.jpg)
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
![Page 50: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/50.jpg)
![Page 51: Clinical Research Finance](https://reader035.vdocuments.mx/reader035/viewer/2022062521/56813b5f550346895da45958/html5/thumbnails/51.jpg)
Contact CRF With Any Questions?