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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
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.
September 20, 2006 Richard Baer, M.D. Medical Director AdminaStar Federal 255 N. Michigan Ave. 22nd floor AFCH-85 Chicago, IL 60601-7601 Dear Dr. Baer: The purpose of this packet is to provide the required information regarding Medicare Claim Reimbursement for Investigational Devices. You will find the items are included in the table of contents and labeled for your convenience. I am submitting information as requested in reference to a new protocol sponsored by SAID COMPANY. The study is STUDY NAME (IDE #GXXXXXX). The study will enroll about 950 patients in total. A maximum of 75 centers will enroll into the study. We would like to request approval of 40 patients at this site. If you need any additional information regarding this matter, please feel free to contact me at 317-962-0816. Sincerely, Ronda Sharp, R.N. Clinical Research Nurse Methodist Research Institute Phone 317-962-0816 [email protected]
METHODIST RESEARCH INSTITUTE
INVESTIGATIONAL DEVICE COVERAGE FORM TO BE COMPLETED AT IMPLANT
Patient Name:_________________________________________________________ Patient MRN:__________________________________________________________ Patient Billing #:_______________________________________________________ Date of Implant:________________________________________________________ Device Name: ______________________________ (Please circle one) MODEL#: ________________________________ Investigational Device Exemption Number (IDE #): #Gxxxxxx
Taxus stent is billed to the patient’s insurance. If the Endeavor stent is used it is donated by the sponsor. There should be a “token charge” of $1.00 for the Endeavor stent per Patient Financial Services.
Fax to Gwen Coffman at 962-8646 or 962-8686 Phone: 962-8565
METHODIST RESEARCH INSTITUTE
Physician Billing of Services
INVESTIGATIONAL DEVICE COVERAGE FORM TO BE COMPLETED AT IMPLANT
Patient Name:_________________________________________________________ Date of Birth: _____________________________ Patient MRN:______________________________ Date of Implant:____________________________ Trial: STUDY NAME Investigational Device Exemption Number (IDE #): #Gxxxxxx Principal Investigator: __NAME___________, M.D. Implanting Investigator: _________________________ Please refer to the Medicare Part B Pre-Approval Letter dated April 25, 2006 for instructions on billing physician services for this procedure.
Fax to ___________ at 962-_______for Krannert Institute of Cardiaology patients. Phone- 962-0527
AdminaStar Federal, Inc. A CMS Contracted Carrier and Intermediary
http://www.adminastar.com
April 25, 2006 NAME, MD Methodist Research Institute 1812 N. Capitol Ave. Wile Hall, Suite 120 Indianapolis, IN 46202 Re: Drug-Eluting Coronary Stent System IDE Number: GXXXXXX Provider Number: Co-Investigators: Dear Dr. __________: I am responding to your request regarding Medicare coverage of the above-identified Investigational Device Exemption (IDE). Please be informed that Medicare Part B will accept billing for physician services related to your participation in the clinical trial involving this device for which the Food and Drug Administration (FDA) has granted IDE Number GXXXXXX. This approval is effective for dates of service on and after April 13, 2006 and is limited to 50 subjects at IU Medical Center & Methodist Hospital according to the protocol approved by the FDA. To confirm the message left by Brettainy Kasemeyer, NAME, MD will not be able to bill Medicare for any patients until he receives his Medicare provider number. Please notify the Part B Medical Policy Unit at AdminaStar Federal when Dr. NAME has received his Medicare provider number. When filing claims for the IDE and physician related services to the Part B Carrier on the CMS-1500 Form, please use the following billing instructions:
Procedure Code(s) Use the procedure code that would be appropriate if the device were non-investigational. In such cases, the claim may be billed electronically.
If an unlisted procedure code (-99) or Category III CPT Code is appropriate, please send a paper copy of the CMS 1500 Form. In addition, a procedure note and copy of this approval letter should accompany the claim.
AdminaStar Federal, Inc. A CMS Contracted Carrier and Intermediary
http://www.adminastar.com
Modifier Use the QA Modifier to identify claims for all investigational device
related services. CMS-1500 Enter the IDE Number for claims related to the IDE in Item 23. NSF Enter the IDE Number in the EAO Field 54. ANSI 4010/4010A1 Enter the IDE Number in the Position 180 REF02 of the REF
segment at the claim level.
Only those costs that are medically necessary for the procedure and associated Part B services for Medicare beneficiary participation in this study are covered. Costs associated with the investigational protocol which are for research purposes and are not reasonable and necessary for the management of the patient are not covered by Medicare. Claims for these services should not be submitted to Medicare; if the patient requests they be submitted, the -GY modifier should be appended. Should the protocol for this investigation be altered, please notify this contractor medical director immediately in writing. Thank you. Sincerely, Carolyn Cunningham, MD Carrier Medical Director, Medicare Part B ec: Richard Baer, MD
Medicare Part AIntermediary
Richard Baer, M.D.Medical DirectorAdminaStar Federal255 N. Michigan Ave. 22nd FloorAFCH-85Chicago, IL [email protected](312) 297-4541
Medicare Part BIntermediary
Carolyn Cunningham, M.D.
Medical Director
AdminaStar Federal
8115 Knue Rd.- AF10
Indianapolis, IN 46250-1936
(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: [email protected]
