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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?