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?