Implications and Issues for Medical Device Trials

1
Implications and Issues for Medical Device Trials

• Seeking Medicare Approval for the Reimbursement
  of a Medical Device

2
Behavioral Objectives

• Be aware of the difference between Category A and
  Category B Medical Device
• Be knowledgeable of the documentation necessary
  to obtain payment approval from Medicare

3
Categories of Investigational Medical Devices

• Category A No FDA Approval
• Category B FDA Pre-Market Approval

4
Category A Experimental

• Class III devices for which there has been no
  pre-market FDA approval.
• Class III devices that would be in Category B,
  but have undergone significant modification for a
  new indication for use.

5
Category B Non-experimental/ Investigational

• Devices comparable to a PMA-approved device which
  are under investigation for a new indication for
  use.
• Devices that become the subject of an
  Investigation Device Exemption (IDE) after FDA
  requires pre-market approval.
• Non-significant risk device investigations for
  which FDA required the submission of an IDE.

• Devices under investigation to establish
  equivalence to a predicate device.
• Devices comparable to a PMA-approved device.
• Devices with technological advances compared to a
  PMA-approved device.

6
Documentation Required for Medicare Payment
Approval of Category B Medical Devices

• Provider name and number.
• Name and number of the device, with a detailed
  description.
• Signed copy of FDA approval letter with Category
  B, IDE status and approval.

• FDA approval letter with most current approved
  number of institutions and subjects and number of
  cases the institution is planning to perform.

7
Documentation to be Maintained by Provider and
Readily Available Upon Request

• Protocol for performing the procedure, with a
  summary of the results of the patients treated.
• Agreement between the company or manufacturer and
  provider.
• Two peer-reviewed publications addressing the
  topic of the study.

• Any product literature illustrating the device
  and/or procedure.
• Protocol used for obtaining informed consent from
  beneficiaries for their participation in the
  study.
• Institutional Review Board (IRB) approval letter.

8
Questions