BMC Clinical Research Policies and Procedures

Transcription

1 BMC Clinical Research Policies and Procedures Presented by: Ellen N. Jamieson, MS, MBA Associate Director, Grants Administration Alexandria Hui Clinical Trial Financial Analyst

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3 Agenda Why New Policy? Compliance Medicare Clinical Trials Coverage Policy - National Coverage Decision (NCD) Consultant Recommendations Standardized Procedures Budget Review Billing Processes

4 Risk areas relating to the costs of clinical research and experimental drug trials specific to hospitals Billing Medicare (or the patient) for items or services that are otherwise reimbursable (or free) to the hospital through federal or private grant funds a.k.a. double billing Billing Medicare for experimental drugs, devices or procedures Charging for an investigation drug in a clinical trial under an investigational new drug application without approval of the FDA Waiving Medicare co-payments and deductible obligations for study participants Coding and billing for non-covered items or services as a covered benefit by an insurer Billing for items and services solely to satisfy data collection needs Billing for items and services provided solely to determine trial eligibility Inadequate medical record documentation for items or services billed Up-coding of billable services Receiving remuneration from research sponsors that could be viewed by Medicare as kickbacks

5 Clinical Research Billing Billing patients or third party payors for products and services provided to patients enrolled in clinical research in accordance with applicable laws and regulations including: Federal health care program requirements e.g., Medicare Part A, B &C National and Local Coverage Policies Final National Coverage Determination (NCD), Medicare Coverage Policy Clinical Trials (Updated July 9, 2007) Coding guidelines established by the cooperating parties for the International Classification of Diseases, 9 th revision, 6 th edition, Clinical Modification ( ICD-9-CM ): AHA, AHIMA, CMS and the National Center for Health Statistics Procedural coding guidelines developed and maintained by the AMA and published in CPT Assistant.

6 2000 National Coverage Decision (NCD) Revised in July 2007 Goal: To provide coverage during a clinical trial for the same services that are covered outside a clinical trial for the same treatment To ensure Medicare beneficiaries are not discouraged from enrolling in clinical trials

7 NCD Basic rule: Medicare covers routine costs during qualifying clinical trials Coverage is not automatic (don t assume) Insurer and/or Contractor may deny Does not affect device billing category (A & B) Qualifying Trials 3 Requirements; 7 desirable characteristics Federal and IND studies qualify, others by agency qualification

8 NCD Routine Costs Routine costs associated with patients enrolled in qualifying clinical trials include: Items and services otherwise available to beneficiaries; Not statutorily excluded; No national non-coverage decision. Routine costs includes items and services that are: Typically furnished absent clinical trial (SOC) Necessary to provide investigational item/service; Required for clinically appropriate monitoring of effect of investigational item/service or for prevention or treatment of complications

9 NCD Routine Costs Excluded Investigational item/service itself But NCD does not supersede Local Coverage Determinations (LCDs) or Category B device rules Items and services furnished solely to determine trial eligibility or satisfy data collection and analysis needs not used in clinical management of patient Items and services customarily provided by research sponsors free of charge for any enrollee in the trial. Research related injuries? Enrolling indigent/uninsured subjects?

10 NCD Qualifying Requirements Part 1: The 3 necessary requirements The study must investigate an item or service that is in a Medicare benefit category Note: NCD does not supercede local coverage determinations (LCD) if Item or service is excluded by LCDs, study doesn t qualify The study must enroll patients with diagnosed diseases The study must have therapeutic intent it must not be designed solely to test the safety or toxicity of the investigational item or service Part 2: The study must be deemed to meet the 7 desirable characteristics only certain types of studies are deemed : Funded by certain government agencies (NIH, DOD, VA) Funded by co-op groups that receive funding from government Conducted under an FDA-approved IND application Exempt from IND requirements

11 NCD Revised as of July 2007 Qualified trials will receive coverage PI must certify to Medicare that criteria are met PI to register in Medicare clinical trial database (which doesn t exist) Routine Costs To provide test article, but not the article itself Some patient monitoring costs (safety, not data collection) Diagnosis and treatment of adverse events

12 NCD Charging for Devices Experimental Devices (Category A) New technology/significant modification Most not billable Medicare Modernization Act of 2004 Category devices for life-threatening conditions are billable Investigational Devices (Category B) Refinement of existing (approved) technology Billable in most cases (FDA/HCFA memo D95-2) Investigational Device Exemption (IDE) Medicare/Insurer may cover Special billing code modifiers

13 Federal False Claims Act Prohibits submitting false information Charges, reports, grant proposals Medicare/Medicaid Billing Knowingly and willingly submit erroneous claim No no scienter protection Criminal and civil penalties (treble damages) Liability is calculated rather than identified

14 Compliance Settlements U. of Alabama at Birmingham ($3.39 M) Allegations Falsely billed Medicare for: Researcher s time spent on patient care when no patients had been seen; and Clinical research trials that were also billed to the sponsor of the research grants Overstated percentage of effort devoted to the grants and falsely reported T/E of employees who did not work on the grants

15 Consultant Recommendations Provide a Centralized Budget Development Process to Research Community Review for NCD eligibility Identify charges as either research related or standard of care (SOC) Create standardized forms Hire a Clinical Trials Financial Analyst Use of BMC CPT4 Codes should be mandatory Define Roles and Responsibilities Create committee to review scientific merit of underfunded studies (non-federal) Communicate changes

16 Challenges in Clinical Research Billing Most billing systems were not constructed with research in mind Research Administration is typically separate from clinical billing department, thus requiring a strong systems link or strong communication Research is decentralized and Investigators/Coordinators often find workarounds