Medicare Submission for Pre-Approval in Clinical Research

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Medicare Submission for Pre-Approval in Clinical
Research

• Ronda Sharp, R.N., B.S.N., C.C.R.C.
• Clinical Research Facilitator
• Methodist Research Institute

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History of Pre-Approval Process

• At Methodist Research Institute, we have been
  submitting for pre-approval for IDE trials since
  1999.
• The process has evolved from sending in 2- 3
  binders of information to CMS on every IDE trial
  to a very streamlined process.
• The timeframe for pre-approval has decreased from
  2-3 months to a matter of 2-3 weeks.

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Goal of Pre-Approval Process

• To provide CMS with information about specific
  IDE clinical trials to assure reimbursement for
  Standard of Care Services for subjects enrolled
  in these trials.
• To comply with CMS guidelines.

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IDE

• IDE- Investigational Device Exemption

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IDE Classification Eligible for Pre-Approval

• Category B
• Certain Category A

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Definition of Category B DeviceNon-experimental/
Investigational

• Devices, regardless of classification, under
  investigation to establish substantial
  equivalence to previously/ currently legally
  marketed device, or
• Class III devices whose technological
  characteristics and indications for use are
  comparable to a PMA-approved device, or
• Class III devices with technological advances
  compared to a PMA-approved device (generational
  changes), or
• Class III devices that are comparable to a
  PMA-approved device which are under investigation
  for a new indication for use. No significant
  modifications to the device were required, or

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Definition of Category B DeviceNon-experimental/
Investigational

• Class III devices that become the subject of an
  IDE after FDA requires pre-market approval (no
  PMA was submitted or the PMA was denied), or
• Non-significant risk device investigations for
  which FDA required the submission of an IDE.

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Definition of Category A DeviceExperimental

• Class III devices of a type for which no
  marketing application has been approved through
  the pre-market approval (PMA process for any
  indication for use.
• Class III devices that would otherwise be in
  Category B but have undergone significant
  modification for a new indication for use.

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CMS

• Centers for Medicare and Medicaid Services

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Divisions of CMS

• Part A- Inpatient Services
• Part B- Physician and Outpatient Services

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Submission Requirements

• Provider name and number (for Part A it would be
  the institution name and number, for Part B it
  would be the PI provider number along with the
  mailing address)
• For Part B, all co-investigators that will bill
  for services must also be listed with the
  submission.

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Submission Requirements(continued)

• Name and Number of the investigational device(s)
  utilized in the trial.
• A narrative description of the device(s).

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Submission requirements(continued)

• Signed copy of the FDA-approval letter
  demonstrating category A or B IDE status.
• The FDA letter containing the most current
  approved number of institutions and subjects (may
  be 2 separate letters).

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Submission Requirements(continued)

• Number of Medicare cases planned for the study at
  the specific institution.
• A copy of the final protocol from the sponsor.

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Additional items to be maintained at the site and
readily available

• The agreement between the company or manufacturer
  and the provider, furnishing the details of the
  provider participation.
• At least 2 peer-review publications.
• Any product literature illustrating the device
  and/or procedure.
• IRB-approval for the protocol to be carried out
  at the institution.

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Medicare Part AIntermediary

• Richard Baer, M.D.
• Medical Director
• AdminaStar Federal
• 255 N. Michigan Ave. 22nd Floor
• AFCH-85
• Chicago, IL 60601-7601
• richard.baer_at_anthem.com
• [phone]

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Medicare Part BIntermediary

• Carolyn Cunningham, M.D.
• Medical Director
• AdminaStar Federal
• 8115 Knue Rd.- AF10
• Indianapolis, IN 46250-1936
• carolyn.cunningham_at_anthem.com
• [phone]

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CMS Website

• www.cms.hhs.gov

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Questions?

• If there are any unanswered questions, I will go
  to the appropriate person to obtain the answer.
• My email address rlsharp_at_clarian.org