1. Columbia University Medical Center Research Billing Compliance presented by Office for Billing Compliance Research Billing Compliance presented by Office for Billing Compliance

2. HISTORY “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damages.” Justice Benjamin Cardozo, New York Court of Appeals Schloendorff v. Society of New York Hospital, 1914

3. General Requirements of DHHS Title 45 Code of Federal Regulations -46 CFR 116 – and FDA Guidance - 21 CFR Part 50 - Subpart B Informed Consent of Human Subjects both state that: “No [clinical] investigator may involve a human being as a subject in research […] unless the investigator has obtained the legally effective informed consent from the subject or subject’s legally authorized representative.”

4. Basic Elements of the Informed Consent Federally supported human subject research must comply with all regulations and policies: 45 CFR 46.116: Protection of Human Subjects – Department of Health and Human Services National Institutes of Health Office for Protection from Research Risks 21 CFR 50.25: Protection of Human Subjects – Food and Drug Administration Department of Health and Human Services

5. Basic Elements of the Informed Consent A statement that the study involves research An explanation of the purpose of the research The trial treatment(s), and The probability for random assignment to each treatment The trial procedures to be followed, including all invasive procedures The subject’s responsibilities Identification of any procedures which are experimental A description of any reasonably foreseeable risks or discomforts A description of any benefits which may be expected from the research An explanation of alternative procedure(s) or course(s) of treatment available A description of compensation and/or treatment in the event of a trial related injury

6. Basic Elements of the Informed Consent The anticipated prorated payment (if any) for participating in the study An explanation of anticipated expenses (if any) for participating in the study An explanation that participating in the trial is voluntary, and an explanation that the subject may withdraw from the trial at any time without penalty or loss of benefit An explanation that access to original medical records must be granted That identifying study records will be kept confidential An explanation of whom to contact for answers to questions about the research An explanation of why trial participation may be terminated An explanation of the expected duration of the subject’s participation The approximate number of subjects involved in the trial

7. Informed Consent is an extension of the Principal Investigator’s study protocol It is more than just a signature on a form. It is an educational process of information exchange and before a subject can be enrolled in a clinical trial, that subject must agree to participate

8. Informed Consent Regulations require the consent document to include a description of any additional costs to the patient that may result from participation in the research These costs can include: - Routine Services - Investigational Devices

9. Additional Costs The Responsibility for Payment of Additional Costs may reside with: Sponsor – this can be »Government »Industry »Private Medicare 3 rd Party Payors Patient / Study Subject

10. The NIH defines research patient care costs as: “the costs of routine and ancillary services provided by hospitals to individuals participating in research programs” Medicare has determined that usual patient care be defined as: “the care which is medically reasonable, necessary, and ordinarily furnished (absent any research programs) in the treatment of patients by providers under the supervision of physicians as indicated by the medical condition of the patients” ROUTINE COSTS

11. On June 7, 2000, the President of the United States issued an executive memorandum directing the Centers for Medicare & Medicaid Services (CMS) to "explicitly authorize [Medicare] payment for routine patient care costs...and costs due to medical complications associated with participation in clinical trials” ROUTINE COSTS

12. Medicare’s consent to pay for routine costs provided to patients enrolled in human subject research means that these services must be provided in accordance with the federal guidelines that govern payment for patient services Including: »Patient cost-sharing obligations »Fraud and Abuse laws and regulations

13. ROUTINE COSTS Medicare deemed criteria: –Trials funded by NIH, CDC, AHRQ, CMS, DOD, and the VA –Trials supported by centers or cooperative groups that are funded by NIH, CDC, AHRQ, DOD, CMS, and the VA –Trials conducted under an investigational new drug application (IND) reviewed by the FDA –Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs.

14. ROUTINE COSTS Routine costs DO include (and are therefore covered) Routine costs do NOT include (and are therefore are not covered)  Items or services that are typically provided absent a clinical trial (e.g. medically necessary conventional care)  Items and services required for the provision of the investigational item or service (e.g., administration of a non- covered chemotherapeutic agent)  Items and services required for the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications  Items and services that are medically necessary for the diagnosis or treatment of complications arising from the provision of an investigational item or service  The investigational item or service, itself  Items and services: --For which there is no Medicare benefit category, or -- Which are statutorily excluded, or -- That fall under a national non- coverage  Items and services furnished solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient (e.g. monthly CT scans for a condition usually requiring only a single scans)  Items and services customarily provided by the research sponsors free of charge for any enrollee in the trial  Items and services provided solely to determine trial eligibility

15. ROUTINE COSTS Investigational Drugs - Medicare covers routine costs The Clinical Trial must Evaluate an item or service that falls into the Medicare benefit category and not have been statutorily excluded Have therapeutic intent or diagnostic intervention and all subjects must have the diagnosed disease (healthy volunteers are assigned proper control groups) Be deemed by Medicare and be: –Conducted under an IND application reviewed by the FDA, or – Exempt from IND application under 21 CFR 312.2(b)(1)- which states that a trial is deemed until the qualifying criteria are developed and the certification process is in place Sponsors of both IND trials and IND-exempt trials must identify themselves by email to: clinicaltrials@cms.hhs.gov

16. Investigational Devices In 1996, Medicare coverage was expanded to include certain investigational medical devices and related medical procedures that are reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body member FDA regulations generally allow sponsors to charge investigators for investigational devices and these costs can usually be passed on to the patients

17. Investigational Devices Category A devices are not covered under Medicare as they do no satisfy the statutory requirement that Medicare pay for devices determined to be reasonable and necessary. Category B devices may be covered under Medicare if they are considered reasonable and necessary and if all other applicable Medicare coverage requirements are met

18. Investigational Devices Medicare Coverage Criteria The device must be used within the context of an FDA approved clinical trial and according to approved patient protocols The device must follow established national or local policies for similar FDA approved devices The device must be medically necessary for the patient The device must be furnished in a setting appropriate to the patient’s medical needs and condition Medicare Payment Criteria Applies to both inpatient and outpatient claims Deductible and coinsurance do apply Inpatient payment for the IDE is bundled into the DRG or non-PPS payment

19. Investigational Devices Preparation for Reimbursement The Principal Investigator must Provide Medicare with: −A copy of FDA approval letter with approved IDE code number provided to the sponsor/manufacturer of the device −Trade or common name of device and classification name −Action taken to conform to any applicable IDE special controls −Narrative description of the device sufficient to make a payment determination −A statement indicating how the device is similar to and/or different from other comparable products −Indication of how device will be billed [ie: inpatient or outpatient] −The name and social security numbers of all patients participating in the clinical trial −The protocol for obtaining informed consents from study patients

20. Investigational Devices Information supporting anticipated billing to Medicare for Investigational Devices should be submitted to: Debi Reifsnyder Education Specialist Empire Medicare Services PO Box 4846 Syracuse, NY 13202

21. Investigational Devices The Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Implications for Medical Device and Medical Equipment Manufacturers

22. Investigational Devices Outline of the New Coverage Effective January 1, 2005 Routine costs associated with Category A trials will be covered if the device is determined to be for use in: -the diagnosis, the monitoring, and the treatment of an immediately life threatening disease or condition Device must be a Category A device Trials must meet criteria established by CMS (appropriate scientific and educational criteria)

23. Office For Billing Compliance Research Billing Compliance Debra Fitzpatrick 305-0571 IRB George Gasparis, Director 305-5883 http://www.cpmcirb.hs.columbia.edu/root/main.htm MEDICARE -Centers for Medicare and Medicaid (CMS) http://www.cms.hhs.gov/medlearn/refctmed.asp?#coverage -Empire Medicare (Local Medicare Carrier) http://www.empiremedicare.com/

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