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
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.
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.
IDE • IDE- Investigational Device Exemption
IDE Classification Eligible for Pre-Approval • Category B • Certain Category A
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
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.
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.
CMS Centers for Medicare and Medicaid Services
Divisions of CMS • Part A- Inpatient Services • Part B- Physician and Outpatient Services
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.
Submission Requirements(continued) • Name and Number of the investigational device(s) utilized in the trial. • A narrative description of the device(s).
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).
Submission Requirements(continued) • Number of Medicare cases planned for the study at the specific institution. • A copy of the final protocol from the sponsor.
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.
Medicare Part AIntermediary • Richard Baer, M.D. Medical Director AdminaStar Federal 255 N. Michigan Ave. 22nd Floor AFCH-85 Chicago, IL 60601-7601 firstname.lastname@example.org (312) 297-4541
Medicare Part BIntermediary • Carolyn Cunningham, M.D. Medical Director AdminaStar Federal 8115 Knue Rd.- AF10 Indianapolis, IN 46250-1936 email@example.com (317) 595-4984
CMS Website • www.cms.hhs.gov
Questions? • If there are any unanswered questions, I will go to the appropriate person to obtain the answer. • My email address: firstname.lastname@example.org