UCLA Health System Value Analysis Committee (VAC) Instructions and Presenter s Guide for Submitting New Technologies/Devices to the Committee

Transcription

1 UCLA Health System Value Analysis Committee (VAC) Instructions and Presenter s Guide for Submitting New Technologies/Devices to the Committee Submission to the Value Analysis Committee is a risk management requirement that must be completed prior to the purchase and use of any new or replacement technologies/devices ( Products ) at UCLA. However, submission to the Value Analysis Committee is required if the Medical Center must purchase a Product that is new to the Medical Center (i.e., not previously approved by the Committee and not already on the formulary). [NOTE: If the intended use of an FDA approved Product is experimental or investigational, regardless of whether the Product is FDA approved under a 510K, PMA, HDE, or IDE, AND the Medical Center will not be required to purchase the Product, then submission to the Value Analysis Committee is NOT REQUIRED. However, all experimental or investigational use Products DO REQUIRE a separate submission to the UCLA Medical Center Financial Services - Reimbursement Department for approval of any proposed or potential Standard of Care charges to insurance (please complete the separate UCLA version of the PalmettoGBA IDE Request Form. You must also complete submissions for the IRB, financial disclosure per UC & CIRC policies, and the appropriate Contracts Office for execution of a clinical device trial/research agreement.] 1. Complete all of the sections of the Value Analysis Committee (VAC) Request for Purchase/Use of a New/Replacement Technology/Device ( Product ) at UCLA Submission Form as completely and concisely as possible. Signatures must be obtained from the Department Chair/Chief and financially responsible manager (e.g., Budget Manager, MSO, or Fund Manager) prior to submission. 2. Return completed form with required signatures to: John Yeretsian, Value Analysis Coordinator c/o Purchasing Wilshire Center, Suite 750 MC Phone (310) FAX (310) Upon UCLA Health System Purchasing Office receipt of a fully completed and signed Value Analysis Committee (VAC) Submission Form an analysis will be completed. Please be advised that this analysis will take approximately six-weeks to complete. When completed, a copy of the analysis results will be sent to you for your review and approval in advance of the required meetings. 4. The requester must attend both a Value Analysis Pre-Planning meeting and subsequent Committee meeting to discuss the request and supply any further information to the Committee. Please note that the Value Analysis Committee meets on a monthly basis for review and decision. 5. For the Value Analysis Committee meeting, each requester is provided a 5-10 minute period for presentation in order to: Describe the patient problem and current medical practice, Introduce/describe the proposed new Product and its expected impact on patient care or research benefit, Provide evidence-based outcome information regarding the new technology, and Review the financial (and if applicable, reimbursement) analysis. [If there are multiple presenters for the Product, it s recommended that the group coordinate their presentation prior to the meeting.] The presentation will be followed by questions from the Committee members. (Questions to anticipate include efforts to standardize Products and whether or not other departments are impacted by the introduction of your new Product). The Committee is dedicated to directing our limited resources to the selection of Products that have the greatest impact on patient care. Since the inception of the Value Analysis Committee, there have been many presentations that did not meet the Committee s requirements and resulted in Products being denied. In these cases, the Committee felt the evidence did not support a high priority score. UCLA Health System VAC Instructions_V.10/9/08 Page i

2 6. Within approximately one week after the Committee meeting, a formal Value Analysis Committee Decision Memo will be sent to the requester. We hope this Instruction/Presenter s Guide will assist you with your introduction of new technologies. If you have any questions about the Value Analysis process, please contact John Yeretsian, Value Analysis Coordinator at or by jyeretsian@mednet.ucla.edu. Thank you, J. Thomas Rosenthal, MD James Atkinson, MD Co-Chair Co-Chair Value Analysis Committee Value Analysis Committee UCLA Health System VAC Submission Form_V.10/9/08 Page ii

3 CONTROL#: (Purchasing Use Only) UCLA Health System Value Analysis Committee (VAC) Request for Purchase/Use of a New/Replacement Technology/Device ( Product ) at UCLA Submission Form SECTION A: PROPOSED USE OF NEW PRODUCT Standard/Routine Clinical Use. Also check one of the following designations: FDA 510k Approved Product(s) for Standard Clinical /Intended Use Humanitarian Use Approved Product (HDE) for FDA Intended Use Only Note: You MUST obtain IRB approval per FDA regulations, prior to humanitarian use of the Product. The following information MUST be provided with this submission: o HDE #: o Indicate who holds the HDE: o Attach FDA HDE Letter. o Attach copy of UCLA IRB Approval Notice (this MUST be submitted with this form) o Attach copy of UCLA IRB Approved Informed Consent Form (if one is available) Pre-Market Approval (PMA) Use Product for FDA Intended Use Only The following information MUST be provided with this submission: o PMA #: o Indicate who holds the PMA: o Attach FDA PMA Letter. Research (Investigational /Experimental) Use Involving Humans (regardless of type of FDA approval). Note: You MUST obtain IRB approval per FDA regulations prior to investigational use. IMPORTANT NOTE: If this box is checked, submission to the VAC is not required UNLESS the Medical Center needs to purchase the Product. In either case, a separate submission to the UCLA Medical Center Financial Services - Reimbursement Director is required (see UCLA version of the Palmetto GBA IDE Request Form for further information regarding this form, contact Felicia Rue, Reimbursement Director at frue@mednet.ucla.edu ), as well as submissions to the IRB, CIRC, and the appropriate Contracts Office. SECTION B: PRODUCT/MANUFACTURER INFORMATON Product(s) Name(s) (Trade, Common/Usual and Classification Name): (If combined equipment is involved, provide information for all items on one form.) Manufacturer: Mfr. Catalog #(s): Sales or Other Representative s Name: Phone Number: SECTION C: CONFLICT OF INTEREST DISCLOSURE STATEMENT Physicians requesting products be admitted to the formulary must complete this conflict of interest section. The University s overall policy on conflict of interest is that none of its faculty, staff, managers or officials shall engage in any activities that place them in a conflict of interest between their official activities and any other interest or obligation. The University s Conflict of Interest Code requires that all University employees and officers disqualify themselves from participating in a University decision when a financial conflict of interest is present. A potential conflict of interest does not, however, disqualify a physician from requesting a Product be added to the formulary. The Committee recognizes that many members of the Medical Staff may have relationships with manufacturing companies. For example, physicians with expertise in a certain area often have received research grants or other support from these companies. Nevertheless, it is critical to the Committee s deliberations that the physician making the request discloses any such relationships up front. 1. List all companies involved in developing, producing and/or distributing the requested Product: 2. List companies with products that may be major competitors with the requested Product: UCLA Health System VAC Submission Form_V.10/9/08 Page 1 of 3

4 3. Do you/your Department have a proprietary, financial, or other interest in any of the companies listed above? [ ] Yes [ ] No If YES, list the company(ies): 4. Do you/your Department have any other interest in any of the companies? Please check all that apply: [ ] Own stock in one of the above companies (excluding mutual funds) [ ] Serve on the board of directors for one of these companies [ ] Expect to receive (or currently receive) >$500 in royalties from one of these companies 5. Have you/your Department received any financial support from the any of the companies listed above? [ ]Yes [ ] No If YES, list the company(ies): 6. If you answer yes to question C.5 above, then please check all that apply and compensation: [ ] Received funding for research- Indicate total compensation: $ [ ] Received support for presenting continuing medical education or other professional education programs supported by the company- Indicate total compensation: $ [ ] Received an educational grant- Indicate total compensation: $ [ ] Received travel support- Indicate total compensation: $ 7. Additional Comments: Please provide any other relevant information about you/your Department s relationship with the company(ies). SECTION D: FDA APPROVED PRODUCT FOR STANDARD CLINICAL CARE/INTENDED USE INFORMATION 1. Briefly describe this Product and clinical impact (also, describe other required components/accessories, if applicable): 2. Is there a product in-house now performing the same function? [ ] Yes [ ] No If YES, what product(s) perform the same function as the requested Product? (Empac#, description, manufacturer, catalog#) 3. Will the requested Product [ ] replace or [ ] supplement current in-house products now performing the same function? [ ] Yes [ ] No If NO, why is it necessary to introduce and use this new Product? 4. What other department(s) will use and/or be affected by this Product? Are each of the other departments aware of this Product and your request? [ ] Yes [ ] No 5. What is the projected annual usage volume of this Product? 6. What is the approximate price of this Product? 7. Do you expect the projected annual dollars spent for this Product will exceed $50,000? 8. Will there be additional implementation costs, such as installation, service agreements, cost of education, and impact on equipment? [ ] Yes [ ] No If YES, please describe: 9. Is the requested Product(s): a) Patient chargeable? [ ] Yes [ ] No b) Urgently Required? [ ] Yes [ ] No If YES, why and how soon? c) Under a current contract? [ ] Yes [ ] No UCLA Health System VAC Submission Form_V.10/9/08 Page 2

5 If YES, please specify by circling: Novation UC Other 10. Do you need a limited evaluation prior to having the Product(s) added to the formulary? [ ] Yes [ ] No If YES, would you be willing to lead the evaluation? [ ] Yes [ ] No If Product needs to be evaluated, who needs to be involved in the evaluation? 11. Need Medical Staff notification? [ ] Yes [ ] No 12. Will use of this Product involve a procedure / process requiring Physician training? [ ] Yes [ ] No 13. How did you find out about this Product? (Please mark all that apply) [ ] Prior experience with Product [ ] Trade Show [ ] Contract Review [ ] Sales Rep came to department SECTION E. REQUIRED SIGNATURES Requesting Physician: Name (Please Print): Department: Phone: Facility: Value Analysis Committee requires the Hospital Budget-Responsible Manager be informed of your initiative and your Department Chair/Chief review and approve your request prior to Committee consideration. All initiatives that are approved and >$5,000 will require Value Analysis Committee review for final decision. Department Budget-Responsible Manager Review: Name: Title: [ ] Informed Comments: Department Chair/Chief Review: [ ] Approved [ ] Denied Comments: Please attach REQUIRED and other helpful supporting documentation (manufacturer s specification, research articles, sales literature and representative s business card) that can assist the Value Analysis Committee in its review of this Product. Return the Fully Completed and Signed Form to Value Analysis Coordinator: John Yeretsian, Value Analysis Coordinator c/o Purchasing UCLA Health System Wilshire Center, Suite 750 MC Phone (310) FAX (310) UCLA Health System VAC Submission Form_V.10/9/08 Page 3