Transcript Medicare Submission for Pre-Approval in Clinical Research

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 PreApproval
Category B
Certain Category A
Definition of Category B Device
Non-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 Device
Non-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 Device
Experimental
Class III devices of a type for which no marketing
application has been approved through the premarket 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 CMS1500 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 A
Intermediary
Richard Baer, M.D.
Medical Director
AdminaStar Federal
255 N. Michigan Ave. 22nd Floor
AFCH-85
Chicago, IL 60601-7601
[email protected]
(312) 297-4541
Medicare Part B
Intermediary
Carolyn Cunningham, M.D.
Medical Director
AdminaStar Federal
8115 Knue Rd.- AF10
Indianapolis, IN 46250-1936
[email protected]
(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]