Get documents about "Medical Device Service Agreement
Description
Medical Device Service Agreement document sample
Document Sample
Project Certification Form
Introduction
Allina Hospitals and Clinics (Allina) recognizes the value the use of certain types of medical devices bring to the
patients we serve and is committed to pioneering the latest treatments for our patients. These Certifications are
needed to facilitate Allina’s decision-making and to ensure that activities subject to the Sponsored Projects Review
Process (SPRP) are conducted in a manner compliant with all applicable law and payer policies.
Certification
As the Principal Investigator/Project Director of this project, I certify the following:
All of the information I have submitted to Allina as part of this proposed project are accurate in all material
respects. The services related to this project are considered routine care, but maybe subject to certain payer
guidelines.
I have accurately identified health care services that are routine care for the study population and do not
constitute (a) investigational drugs, medical devices or procedures, or (b) non billable protocol induced
costs. At Allina’s request, I will provide information which supports my conclusions regarding services
identified as routine care related to this project.
I will abide by Allina policies and procedures, including, but not limited to all policies, conditions and
requirements of the IRB, applicable laws and regulations, and will comply with sponsor’s protocol and
policies to the extent consistent with Allina’s policies and applicable laws.
I have read and understood the “Allina Hospitals and Clinics Guide to Research Billing and the Sponsored
Projects Review Process” (Guide) for the completion of the Project Setup Worksheets and the project
being submitted is in accordance with those instructions.
I understand that I am responsible for the conduct of this project in Allina facilities.
I agree to update the information I have provided to Allina as part of this proposed project if changes occur
or errors are discovered.
I agree that I or my staff will cooperate, in good faith, with Allina to assist in conducting any review or
investigation should that be required for billing or compliance purposes.
I understand that Allina may suspend its participation in this project for any reason upon providing written
notice.
This project is limited to the use of the device related to this project. I may not have access to this device
after the project is completed. I will need to follow Allina’s process for new technology or devices in order
to access it after the project.
I understand that if the HUD status of this devices changes, I may need to submit a new project to Allina
SPA.
Project Title*: 0
0
Study Protocol # (as assigned by sponsor)*: 0
Principal Investigator/Project Director Signature Date
0
Principal Investigator/Project Director Name
Department Director Signature (Allina Department Projects Only) Date
ALLINA HOSPITALS AND CLINICS
SPONSORED PROJECT/RESEARCH INFORMATION WORKSHEET
FOR HUMANITARIAN USE DEVICE PROJECT
Your project cannot start at an Allina facility until it has been approved by the Business Unit's
Administration and Allina Sponsored Projects Administration. All fields with an * are required.
Consult Part III of the Guide for assistance in completing this form.
General Information
Project Title*:
Project Title cont.:
Project Title Short Name (optional):
Study Protocol # (as assigned by sponsor)*: Allina IRB #:
Project Sponsor*:
Anticipated Project Start Date*: Anticipated Project End Date:
Allina Facility*: 1
HUD projects must me submitted to an Allina IRB for Human Subjects review?* TRUE
Yes FALSE FALSE
Principal Investigator/Project Director
Yes No
Name*: Allina Employed*: FALSE FALSE
Phone*: Fax:
Include Area Code Include Area Code
Internal Zip (if applicable):
Practice Group or Allina Facility Dept.*:
Address*:
City*: State*: Zip*:
Research Coordinator/Project Contact
Name*: Allina Employed*: FALSE
Yes FALSE
No
Phone*: Fax: -
Include Area Code Include Area Code
Pager: Internal Zip (if applicable):
Include Area Code
Practice Group or Allina Facility Dept.*: 0
Address*: 0
City*: 0 State*: 0 Zip*: 0
E-mail address*:
75dfbf87-51ed-4ea9-8634-1629fac25bf7.xls (c) 2001-2004 Allina Hospitals Clinics 3/10/2011 4:19 PM
SPONSORED PROJECT/RESEARCH INFORMATION WORKSHEET - Continued
Participant Information
Estimated Number of Participants (at this local site)*: This can't be a range
(Please check all that apply below):
Inpatient
FALSE Estimated #
Outpatient
FALSE Estimated #
Do you expect this project to result in additional inpatient days or increase the time necessary to provide outpatient services?*
FALSE Yes. Please comment on what is expected FALSENo
Payment and Billing Information
Research Site's Plan Code*: Note: Research services cannot be scheduled without a plan code.
FDA Assigned Number:
TRUE
Comments (you may attach additional sheets if necessary)
75dfbf87-51ed-4ea9-8634-1629fac25bf7.xls (c) 2001-2004 Allina Hospitals Clinics 3/10/2011 4:19 PM
ALLINA HOSPITALS & CLINICS
HUD Medical Device Information Worksheet
This worksheet must be completed and submitted along with the requirements listed on the worksheet "FI
Checklist". Instructions can be found in Part III of the Guide. You may need to attach additional sheet(s) for the
detailed device information below.
Project Title:
0
Project Title cont.: 0
Project Sponsor: 0
Principal Investigator: 0 Research Plan Code 0
Practice Group or Allina Facility & Dept.*: 0
FDA Assigned Number: 0
What is the name of a comparable device?
List each device used as part of the Humanitarian Use Device, along with the all the sizes that will be used. The Sponsor may be the best
resource to get this information.
Humanitarian Use Device Information
Manufacturer/Item
Manufacturer/Supplier Name of Device Number Unit (ea., box, pkg.) Size Cost
Approved Device Information
Manufacturer Item
Manufacturer/Supplier Name of Device Number Unit (ea., box, pkg.) Size Cost
List the name of Person SPA can contact at the sponsor or manufacturer and contact information?
Allina Signatures Only Signatures Printed Name Date
Supply Chain Management
Finance Department
Charge Master
SPA
FDA-Approved Humanitarian Use Device (HUD)
Pre-Approval Data Submission Request Form
Note: The verification of and validity of all documentation remains the provider’s responsibility, as is the guarantee
that Medicare is billed according to Medicare guidelines.
1. The name of the device (both trade, common or usual and classification name) and a narrative
description of the device. Include a statement as to the devices similarities and differences from other
products if not explicitly and clearly indicated in submitted documents.
2. A copy of FDA approval letters provided to the provider and/or the sponsor or manufacturer of the
device. (Please note that letters including redactions will result in delays and not the responsibility of
SPA)
3. A copy of the approval letter from the Provider’s Institutional Review Board (IRB). (A copy of the
approval letter for any time extension or other update must also be submitted after the initial approval
occurs.)
4. A description of the action(s) taken to conform to any applicable FDA and/or IRB special controls
and/or other requirements.
5. A copy of the study protocol, including patient inclusion criteria. The provider may elect to
delineate the Medicare-billed services on this protocol or follow the procedure described in #9 below.
On this protocol copy, for each service or procedure in the protocol, indicate next to the service or
procedure either the word “study” to indicate the service or procedure is a cost and responsibility of the
study (and will not be billed to Medicare) or the word “Medicare” for a service or procedure which (a) is
medically necessary for the patient’s care, (b) would have been incurred in the absence of the study and
(c) is an Medicare-covered benefit/service. (Allina will be submitting SPA Project Setup Worksheets,
which provides the breakdown of items and services.)
6. A copy or description of the Provider’s protocol for obtaining informed patient consent.
7. A sample of the patient consent form. Form must clearly describe the patient’s financial
responsibility. Form also must clearly indicate any financial or other interest of the participating
provider(s) and others at the facility directly involved in the conduct of or directly affected by the
8. Copies the study.
outcome of of all agreements between the sponsor and the provider, especially but not limited to,
financial agreements. Note that any and all payments for each aspect of the study must be included.
Please mark N/A if you do not have a written agreement with the sponsor.
9. The Principle Investigator’s (PI’s) budget for the study, showing allocation of all funds from all
sources. If not indicated on the protocol itself, the budget should specify both the costs of the services
(including evaluations), tests and procedures that will be performed throughout the course of the study
and which will be billed to Medicare. Submit the PI’s determination of which tests and procedures are
necessary to the “research” and which tests and procedures are “standard of care” for the treatment of
the underlying disease in the absence of the study intervention. Please mark N/A if you are not
receiving any funds from the sponsor.
10. A description of the facility’s processes/procedures for ensuring that Medicare is not billed for any
non-routine care costs and sponsor or other reimbursed costs.
Failure to submit each item above may result in disapproval of the device.
FDA-Approved Humanitarian Use Device (HUD)
Pre-Approval Data Submission Request
Page 2
“I certify the above is accurate and complete and understand that it is my responsibility to ensure that claims are
submitted to Medicare in compliance with Medicare guidelines.”
[Typed Name of Person Signing Form]
[Enter Title of Person Signing Form]
Consideration for approval of the device will occur only after receipt of each of the above completed items.
PLEASE COMPLETE THE FOLLOWING
Provider Number:
HUD/HDE#: 0
Date information is being mailed:
Contact Person for your facility: Kurt Sargent
Contact Phone Number: 612-262-4926
Contact E-mail: kurt.sargent@allina.com
Contact Regarding Technical/Clinical Questions: 0
Contact Regarding Technical/Clinical Questions Phone Number: 0
Send all requests to: Submitted by:
Noridian Administrative Services, LLC Allina Hospitals and Clinics
Medicare Part A Sponsored Projects Administration - 10105
Attn: IDE Coordinator PO Box 43
901 40th Street S Suite 1 Minneapolis, MN 55440-0043
Fargo, ND 58103
ALLINA HOSPITALS & CLINICS
HUD MEDICAL DEVICE PROJECT SUBMISSION CHECKLIST
Submit the following printed documents to Allina SPA.
Signed Principal Investigator Certification
Information Worksheet
Completed Devie Worksheet or other information with similar information
Case for Support
Submit these worksheets electronically to spa@allina.com
Two signed original copies of the Allina Humanitarian Use Device Agreement (External Entity Only)
Signed copy of the FI (Fiscal Intermediary) Checklist
The items listed on the FI Submission Checklist
