FMCNA Clinical Studies Department

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FMCNA Clinical Studies Department
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History of Clinical Research at FMCNA

• 1960s and 1970s
• Evaluation of new dialysis products
• Investigation of clinical and therapeutic
  responses
• Collaborative Studies with academic programs
• 1980s thru 1996
• Investigation of side effects and unintended
  consequences
• Development of 1st large database- Patient
  Statistical Profile (PSP)
• Drug Studies and outcomes
• Optimum therapeutic approaches-Goals and Action
  Thresholds
• 1996 and beyond
• Development of Clinical Studies Department
• Formalized agreements for research studies
• Data licenses

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Primary Functions of Clinical Studies Department

• Coordination of research projects through FMCNA
  Corporate office
• Coordinate Internal studies - function similar
  to an SMO
• Oversight of External (physician originated and
  managed) research in FMCNA facilities
• Manage Data Licensing Projects
• Maintenance of the research database
• catalogue all studies
• Summaries sent to field level management (BUPs,
  RVPs and BUCOs) monthly
• Manage self-monitoring compliance program

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Self Monitoring Program

• Compliance with all applicable regulations
• Quarterly audits in randomly selected studies
• Audit for inappropriate billing of study related
  drugs, labs, and services
• Audit sample selected based on OIG Work plan and
  risk for FMCNA associated with a study. For
  example
• High risk medication used in the study is also
  in FMC formulary and the study does not use a
  central lab
• Low risk investigational drug and the study
  utilizes a central lab.
• Results are periodically reviewed by OIG

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Compliance Issues

• Every project must stand on its own merit with
  clear purpose, design and guidelines
• Program must comply with Stark Regulations
• Pricing must be within Fair Market Value (FMV)
• To FMCNA from sponsors for Central studies
• From FMCNA to investigators for physician and
  nursing compensation in study budgets
• inconsistent payments among physicians or
  elevated payment among all physicians
• must demonstrate payments to physicians are
  within FMV, not an improper inducement to perform
  the research.
• For data licensing projects
• Other concerns
• billing for study items
• changing frequency of tests or services as a
  result of study results
• Except under Medicare National Coverage Decision
• Facility staff may unwittingly disclose
  proprietary information e.g completing
  questionnaires about product use at a facility.
• Every project that we embark on has been
  carefully examined by Clinical Quality,
  Compliance, and Legal Departments and will
  withstand scrutiny from outside sources

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Stark Anti-Kickback Regulations

• If physician-investigator makes referrals to
  facility for designated health services (DHS),
  all financial relationships must comply with
  Stark Regulations
• Prohibits soliciting, receiving, offering or
  paying any remuneration in return for referring a
  patient or to induce the referral of a patient to
  any person for any item or service for which
  payment may be made under a Federal health care
  programs
• Failure to comply means DHS referrals are
  prohibited- i.e. facility cannot bill
  Medicare/Medicaid for services
• Civil monetary penalties, possible False Claims
  Act liability
• Review all financial relationships with
  investigators who make referrals to ensure that
  there is no intent to induce referrals in
  violation of the statute

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Compliance Issues

• Every project must stand on its own merit with
  clear purpose, design and guidelines
• Program must comply with Stark Regulations
• Pricing must be within Fair Market Value (FMV)
• To FMCNA from sponsors for Central studies
• From FMCNA to investigators for physician and
  nursing compensation in study budgets
• inconsistent payments among physicians or
  elevated payment among all physicians
• must demonstrate payments to physicians are
  within FMV, not an improper inducement to perform
  the research.
• For data licensing projects
• Other concerns
• billing for study items
• changing frequency of tests or services as a
  result of study results
• Except under Medicare National Coverage Decision
• Facility staff may unwittingly disclose
  proprietary information e.g completing
  questionnaires about product use at a facility.
• Every project that we embark on has been
  carefully examined by Clinical Quality,
  Compliance, and Legal Departments and will
  withstand scrutiny from outside sources

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Medicare National Coverage Decision

• In September 2000 Medicare expanded coverage of
  routine costs related to qualifying clinical
  trials and subsequent services necessary to
  address any complications.
• Items and services generally available to
  Medicare beneficiaries
• Trial must have therapeutic intent
• Most government-funded trials and trials under an
  IND exemption will qualify
• Defines specific modifiers and codes to be used
  in billing for research related services
• Medicare does not cover
• services if other funding (e.g. from sponsor)
  covers cost
• experimental/investigational care (medically
  unnecessary)
• services related to non-covered services

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Compliance Issues

• Every project must stand on its own merit with
  clear purpose, design and guidelines
• Program must comply with Stark Regulations
• Pricing must be within Fair Market Value (FMV)
• To FMCNA from sponsors for Central studies
• From FMCNA to investigators for physician and
  nursing compensation in study budgets
• inconsistent payments among physicians or
  elevated payment among all physicians
• must demonstrate payments to physicians are
  within FMV, not an improper inducement to perform
  the research.
• For data licensing projects
• Other concerns
• billing for study items
• changing frequency of tests or services as a
  result of study results
• Except under Medicare National Coverage Decision
• Facility staff may unwittingly disclose
  proprietary information e.g completing
  questionnaires about product use at a facility.
• Every project that we embark on has been
  carefully examined by Clinical Quality,
  Compliance, and Legal Departments and will
  withstand scrutiny from outside sources

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External Studies

• External Studies
• pharmaceutical company contracts directly with
  the physician or physician group
• Physician or Physician group responsible to
  sponsor
• Approval Process
• Clinical Trial Agreement
• Identification of study locations
• Protocol
• IRB approval
• IRB approved informed consent (FMC requires
  disclosure of MD payment for study work)
• HIPAA authorization if consent not HIPAA
  compliance
• Study lab agreement if no central lab (this is to
  prevent inappropriate billing of study related
  items or services)
• Approval sign-offs
• CMO, Clinical Quality, RVPs, AMs, CMs
• Impact on clinical staff and patient care
• FMCNA patient care staff involvement in research
  limited to
• Drawing study bloods (tubes must be readily
  available and well labeled)
• Administering IV study meds (dont want non-FMC
  employees manipulating blood lines)
• Corporate Legal and Compliance
• Compliance risk

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Clinical Trial Agreement

• Purpose of Clinical Trial Agreement
• Primary to indemnify FMC should a patient be
  harmed as a result of study participation.
• Secondary to recoup study related fees
• 15 overhead fee charged (per pt and prorated
  according to participation) cannot offer a
  service of value for free to a potential referral
  source
• Recoup study related lost revenue if an item we
  normally bill for is stopped during a study, we
  charge that fee to the study sponsor (calculated
  by finance department, weighted average according
  to product and payer).
• Approximately 50 percent of the 15 overhead
  dollars are returned to the facilities
  participating in the studies
• 100 of lost revenue is returned to facilities

For Pharmaceutical Sponsored studies
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External Studies

• External Studies
• pharmaceutical company contracts directly with
  the physician or physician group
• Physician or Physician group responsible to
  sponsor
• Approval Process
• Clinical Trial Agreement
• Identification of study locations
• Protocol
• IRB approval
• IRB approved informed consent (FMC requires
  disclosure of MD payment for study work)
• HIPAA authorization if consent not HIPAA
  compliance
• Study lab agreement if no central lab (this is to
  prevent inappropriate billing of study related
  items or services)
• Approval sign-offs
• CMO, Clinical Quality, RVPs, AMs, CMs
• Impact on clinical staff and patient care
• FMCNA patient care staff involvement in research
  limited to
• Drawing study bloods (tubes must be readily
  available and well labeled)
• Administering IV study meds (dont want non-FMC
  employees manipulating blood lines)
• Corporate Legal and Compliance
• Compliance risk

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Centrally Coordinated or Internal Studies

• Central Projects
• FMCNA has negotiated and contracted with
  pharmaceutical company to provide site management
  services
• FMCNA subcontracts with physicians or physician
  groups who employ coordinators or will employ
  coordinators
• Same approval process as external studies
  required
• Same documentation as external studies required
• Current Active Total
• (6)studies in (100) Investigative sites
• Centrally coordinated studies with the following
  sponsors
• Advanced Magnetics
• Amgen
• Genzyme
• Nabi Biopharmaceuticals
• Roche
• Shire

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Data Licensing Projects

• Contract with pharmaceutical companies to develop
  retrospective analyses using the extensive FMCNA
  database
• Have agreements with other organizations
  (academic nephrology programs, USRDS, DOPPS, etc)
  to share data
• Approval Process and Data Licensing Agreement
• Project legitimacy
• Purpose or goals of data collection and analyses
• How data will be used/displayed
• Assure that funding from pharmaceutical company
  can not be perceived as improper inducement for
  product purchase
• List of data elements to be included
• Pricing of data elements
• Appraisal of Fair Market Value by Health Care
  Appraisers, Inc
• Some elements are proprietary
• Do not license mortality or hospitalization data
  without prior agreement as how data will be used
• FMCNA allowed to review analyses of the data and
  conclusions prior to public use or publication
• May elect beforehand to participate in the
  analyses and publication of data and thus be
  identified
• If FMCNA disagrees with analyses or data, may
  require that we not be identified with the
  analyses or conclusions in any publications or
  presentations