Columbia University Medical Center

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Columbia UniversityMedical Center

• Research Billing Compliance
• presented by
• Office for Billing Compliance

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Informed Consent

• 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
• patients 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

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• 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
• subjects legally authorized representative.

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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

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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 subjects 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

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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
  subjects participation
• The approximate number of subjects involved in
  the trial

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• Informed Consent is an extension of
• the Principal Investigators 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

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Informed Consent Billing Compliance

• 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

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Additional Costs

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

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ROUTINE COSTS

• 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

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ROUTINE COSTS

• 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

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ROUTINE COSTS

• Medicares 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

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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.

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ROUTINE COSTS

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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_at_cms.hhs.gov

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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

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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

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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 patients 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

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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

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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

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Investigational Devices

• The Medicare Prescription Drug, Improvement,
• and Modernization Act of 2003 Implications for
• Medical Device and Medical Equipment
• Manufacturers

Important Medicare Update
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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)

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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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