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Breakage and Complaint Reimbursement Policy

Policies and procedures for the return of and potential reimbursement for product due to a product quality compliant or mishandling by a duly licensed provide or patient. Effective date: April 1, 2018.

This Breakage and Complaint Reimbursement Policy (“Policy”) of Mitsubishi Tanabe Pharma America, Inc. (“MTPA”) applies to returns of Radicava® (edaravone) (“Product”) purchased from an Authorized Distributor of Record (“ADR”) by a provider that is duly licensed to dispense or administer the Product (“Provider”). Providers include Physician Offices, Home Infusion Sites, Clinics, and Hospitals.

This Policy is applicable when the Product is subject to a product quality complaint (“PQC”) or is mishandled by the Provider or Patient, in which case the Product may be eligible for reimbursement by MTPA.*

PLEASE NOTE THAT REIMBURSEMENT IS AVAILABLE FROM MTPA — UNDER THIS POLICY OR OTHERWISE — ONLY IF THE PRODUCT UNIT(S) SUBJECT TO THE REIMBURSEMENT REQUEST IS SENT BACK TO MTPA.

In summary, under this Policy the Provider must: (1) report to MTPA Medical Information any applicable Product Quality Complaint (“PQC”) or Product mishandling by Provider or a patient in connection with the storage or administration of the Product; (2) complete a Breakage and Complaint Claim Form (“Form”); and (3) send to MTPA the completed Form and a copy of the original invoice from the ADR for the Product that is to be returned. MTPA will review completed requests for reimbursement under this Policy. These steps are described in more detail below.

Potential reasons for Product reimbursement under this Policy include:

  • Product was subject to a validated PQC;
  • Product was subject to a reported PQC, but the reported event cannot be validated;
  • or

  • Product was improperly handled by Provider or a patient of the Provider

REIMBURSEMENT FOR PRODUCT MISHANDLING AND FOR REPORTED PQC EVENT(S) THAT CANNOT BE VALIDATED IS CAPPED AS DESCRIBED IN SECTION II.C BELOW. PROVIDERS THAT REQUEST REIMBURSEMENT IN THESE CIRCUMSTANCES MAY BE ASKED OR REQUIRED TO UNDERGO PRODUCT ADMINISTRATION TRAINING AS A CONDITION OF RECEIVING THE REIMBURSEMENT, IN THE SOLE DISCRETION OF MTPA.

Reimbursement is not available under this Policy where, for example:

  • Product is shipped in error by MTPA; Product is damaged in transit to the Distributor; or Product is expired. Please follow the MTPA United States and Its Territories Return Goods Policy in these circumstances.
  • Product is shipped in error by the ADR or damaged in shipping to the Provider; or Product is mailed in error by the Provider or damaged in mailing to the patient. No credit is available from MTPA in these circumstances, under this Policy or otherwise.
  • Product is not infused due to patient decision to discontinue therapy and/or failure to show up for infusion appointment.
  • Product has been infused and Provider or patient is unsatisfied with the therapeutic result.

PLEASE NEVER INFUSE A UNIT OF PRODUCT FOR WHICH THE SPIKE HAS BEEN IMPROPERLY INSERTED INTO THE INFUSION BAG STOPPER. FOR OTHER IMPORTANT SAFETY INFORMATION, PLEASE REFER TO THE RADICAVA PACKAGE INSERT ENCLOSED WITH EACH UNIT OR AVAILABLE AT https://www.radicava.com/assets/dist/pdfs/radicava-prescibing-information.pdf

*MTPA has the right to modify or discontinue this Policy at any time without notice. Nothing in this Policy should be construed to be a guarantee of the safety or effectiveness of Product. The treating healthcare provider is solely responsible for ensuring that Product delivered to the patient is dosed and infused in a manner consistent with the FDA-approved labeling and sound medical judgment.

I. DEFINITIONS

“Product Quality Complaint” means any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a product placed on a market or used in a clinical trial. This includes reports of product, labeling, packaging or product container defects, or failure of the product to meet specifications or perform as expected.

“Mishandling” means a mistake or error by Provider or patient in the administration or storage of Product.

II. PROCESS & REQUIREMENTS

A. Initial Report

Provider (and/or any other individual) follows the steps below to report the PQC or Mishandling event:

  • Collect the following necessary information to report:
    • The name of the Product
    • The date of the incident, if available
    • The date that the complaint was received (i.e. awareness date)
    • Product identification information(s) (e.g. Lot number, NDC number, expiration date etc.)
    • Serialization number on the cartons and/or shipper
    • Defective quantity, total inventory for the lot at the site
    • The name, address, email and phone number of the reporter and the end-user (if different from the reporter and if available).
  • Collect and report the details and circumstances of the incident or complaint, including but not limited to:
    • Details of any allegations of any adverse drug experience or health safety concerns (e.g. death, severe allergic reactions, serious injury or harm(s) caused by the Product etc.)
    • Document if the end user could not or did not provide any of the above information.
  • All PQC and related information shall be reported to the MTPA Medical Information call center no later than one (1) business day of receipt of the information by using the following listed phone number:
    • Tel 1-888-292-0058

B. Evaluation

  • MTPA will provide a Breakage and Complaint Claim Form (“Form”) to the Provider for the Provider to complete.
  • The Provider returns to MTPA the completed Form and a copy of the original invoice from the Provider’s ADR for the Product. (Original invoice required only if credit is requested.)
  • Once the completed Form and invoice are received, MTPA will follow up with the Provider as necessary with any questions, or request that an RGA be sent to the Provider. THE RGA IS ISSUED UPON UNCONFIRMED REPRESENTATIONS MADE TO MTPA AND IS NOT INTENDED TO BE A GUARANTEE OF REIMBURSEMENT.
  • Provider must return the RGA, the bag of Product subject to the PQC / mishandling, and the carton (in which the bag was received) to the address specified on the RGA, within three (3) business days of receipt of the RGA. NO CREDIT WILL BE ISSUED FOR A PRODUCT RETURN UNLESS THE BAG AND ITS CARTON ARE PHYSICALLY RETURNED TO MTPA AS INSTRUCTED BY THE RGA.
  • Once Product has been received by MTPA’s returns processor an investigation will be completed by MPTA Quality Assurance personnel to determine, in MTPA’s sole discretion, whether the circumstances involve a validated PQC or a Mishandling event.

C. Reimbursement

  • Reimbursement under this Policy will not be issued until Product has been received and the Quality Assurance investigation has been completed.
  • If / when reimbursement is approved, it will be in the form of a credit processed through the Provider’s ADR.
  • Please be advised that once Product has been received and the investigation begins, MTPA will seek to complete its review and process the credit (if applicable) in approximately thirty (30) business days.
  • REIMBURSEMENT UNDER THIS POLICY IS CAPPED AS FOLLOWS:
    • FOR PRODUCT MISHANDLING AND FOR REPORTED PQC EVENT(S) THAT CANNOT BE VALIDATED: UP TO TWO (2) CARTONS PER 12 MONTH PERIOD PER IN-OFFICE / IN-CLINIC DISPENSING PROVIDER, OR ANY OTHER SITE OF CARE BESIDES HOME INFUSION; AND UP TO TEN (10) CARTONS PER 12 MONTH PERIOD PER HOME INFUSION PROVIDER. CAP IS APPLIED AT THE CORPORATE ENTITY LEVEL, NOT AT THE SITE OF CARE, SHIP TO, OR PATIENT ADDRESS LEVEL. 12 MONTH PERIOD IS DETERMINED BASED ON DATE OF OCCURRENCE OF PQC / MISHANDLING EVENT.
    • FOR VALIDATED PQC EVENT(S): NO CAP APPLIES.
  • If one bag of Product is approved for credit, then a credit in the amount of half of the WAC in effect at the time of purchase, less any applicable discount, will be credited to the Provider. For purposes of applying the cap described above, a credit for one bag shall count as half a credit.
  • MTPA will incur all charges for processing and destroying Product that is physically returned as instructed by the RGA. MTPA will not assume any responsibility for charges incurred for Product returned to a facility other than that authorized, or for Products shipped to an approved facility but without prior authorization from MTPA.

III. ADDITIONAL TERMS AND CONDITIONS

A. Conditions of Return

  • RGA issuance will include pre-paid shipping information. MTPA will not reimburse fees due to processing third-party returns, destruction charges, shipping costs, or processing outside of this Policy and associated procedures.
  • A valid RGA must accompany all returns. If Product is returned without an authorized RGA, it will be rejected and destroyed upon inspection of the return.
  • Returned Product must be in the original primary container, cartons and bags.
  • Product must be returned by the Provider who purchased the Product from an ADR.
  • Product dispensed to a patient by a Provider should be returned by the Patient to the Provider, and from the Provider to MTPA (as instructed in the RGA).
  • By accepting credit, Provider agrees to produce promptly to MTPA upon request information confirming that any reimbursement initially received by Provider from insurer or patient for Product that receives a credit under this policy has been reversed or refunded. Failure to provide this information promptly could result in Provider losing eligibility for future credits.


B. Additional Terms

  • All returns are subject to review and approval by MTPA. Issuance of the Form and/or an RGA does not guarantee Product reimbursement.
  • MTPA will, in its sole discretion, authorize reimbursement for the returned Product.
  • MTPA reserves the right to impose a handling fee on all retuned goods.

Return Goods Policy

Policies and procedures for returning any Mitsubishi Tanabe Pharma America product sold in the United States and its territories. The terms apply to expired Product and Product subject to a Product Quality Compliant and/or potential Adverse Event. Effective date: October 18, 2017.

I. Policy Statement

This United States Return Goods Policy (“Return Policy”) for Mitsubishi Tanabe Pharma America, Inc. (“MTPA”) applies to any MTPA product (“Product”) sold in the United States and its territories. The terms of this Return Policy apply to expired Product and Product subject to a Product Quality Complaint (“PQC”) and/or potential Adverse Event (“AE”).

THIS RETURN POLICY IS SUBJECT TO CHANGE AT ANY TIME WITHOUT PRIOR NOTICE.

II. Return Designee

(A) Unless otherwise instructed, all MTPA Product returns should be sent to MTPA’s Authorized Return Goods Vendor at the address below:

Mitsubishi Tanabe Pharma America, Inc.
Attn: Returned Goods
15 Ingram Blvd, Dock 43
LaVergne, TN 37086

(B) MTPA incurs the cost for processing and destruction of Products properly returned to MTPA’s Authorized Return Goods Vendor. MTPA will not assume responsibility for charges incurred by customers using other means for processing returns and destruction.

III. Returns of Expired Product

(A) AUTHORIZATION FOR RETURN:

  1. To initiate a Product return for expired Product that is not subject to a PQC or AE, the Authorized Distributor of Record shall contact MTPA’s Authorized Return Goods Vendor via email (GMB-SPS-ReturnRequests@cordlogistics.com) or by fax (615-652-0271) to obtain a Return Goods Authorization (“RGA”). To ensure consideration for reimbursement, all returned Products must be accompanied by a RGA and shipped pre-paid.
  2. Products not suitable for use, whether or not eligible for reimbursement (i.e. unexpired product), are to be returned to the Authorized Return Goods Vendor for evaluation, disposal and destruction and must include a RGA. NO REIMBURSEMENT WILL BE ISSUED FOR UNEXPIRED PRODUCT.
  3. All Product returns must be accompanied by a RGA.
  4. The RGA is valid for sixty (60) days from issuance. All Product must be returned to the Authorized Return Goods Vendor within sixty (60) days of the issuance of the RGA.
  5. To speak with MTPA’s Order/Returns Service, call: Toll Free Number – 844-529-8990; Fax – 614-652-4374
  6. THE RETURN GOODS AUTHORIZATION IS ISSUED UPON UNCONFIRMED REPRESENTATIONS MADE TO MTPA’S AUTHORIZED RETURN GOODS VENDOR AND IS NOT INTENDED TO BE A GUARANTEE OF REIMBURSEMENT OR REPLACEMENT.
  7. MTPA will not assume any responsibility for charges incurred for Product returned to a facility other than MTPA’s Authorized Return Goods Vendor. Products shipped to the Authorized Return Goods Vendor without a prior issued RGA from MTPA will not be eligible for reimbursement.
  8. A Healthcare Provider (i.e. physician’s office, infusion center, clinic) shall initiate the return of Product by contacting the Authorized Distributor of Record from which it purchased the Product.
  9. Credit for a return shall be issued only to an Authorized Distributor of Record.

(B) RETURNING THE PRODUCT:

(1) Each return shipment of Product to the Authorized Return Goods Vendor must contain:

  1. Name, address, DEA # or HIN # and contact information for facility returning the Product
  2. Authorized Distributor of Record’s (entity Product was purchased from) name, address, and contact information
  3. Reference Number from the RGA
  4. Name and address of the customer’s current Authorized Distributor of Record to whom credit will be remitted
  5. List of Products, including quantity being returned, lot number, serialization number and expiration date of each
  6. Original Carton
  7. Debit Memo Number (see below)
  8. Reason for return
  9. Date of Return

(2) Only one (1) debit memo number/proof of purchase is allowed per return shipment. If a return shipment contains multiple boxes, a photocopy of the paperwork with debit memo number/proof of purchase must be placed in each box.

C. OUTDATED PRODUCTS NOT ELIGIBLE FOR REIMBURSEMENT:

No credit for a product return is available in the following circumstances:

  • Product not purchased directly from a MTPA Authorized Distributor of Record.
  • Product that is received more than six (6) months past the product’s expiration date.
  • Product damaged due to improper storage, handling, fire or catastrophe, unless otherwise qualifying as a returnable item.
  • Product destroyed or damaged from insurable causes.
  • Product distributed at no charge.
  • Product that has been sold expressly on a non-refundable basis.
  • Product obtained illegally or via diverted means.
  • Product purchased on behalf of other manufacturers, institutions, contract research organizations, or others for use in clinical trials or studies, Phase IV studies, or for charitable donations.
  • Product with a prescription label on either the bag or carton.
  • Product not in original containers.
  • Product with labels removed or illegible.
  • Product involved in salvage, bankruptcy or insolvency proceedings.
  • Private label or repackaged Products.
  • Product for which proof of purchase cannot be verified.
  • Partial bags.

IV. Shipping Errors/Damaged Shipments

(A) Product shipments received in error or damaged in transit from a MTPA Authorized Distributor of Record must be reported to the Authorized Distributor of Record.

(B) Product shipments received in error or damaged in transit from a pharmacy provider must be reported to the pharmacy provider.

(C) MTPA IS NOT RESPONSIBLE NOR LIABLE FOR PRODUCT SHIPMENTS RECEIVED IN ERROR FROM AN AUTHORIZED DISTRIBUTOR OF RECORD OR DAMAGED IN TRANSIT.

V. Returns Related To PQCs And/Or AEs

(A) For Product returns due to a PQC and/or AE, Authorized Distributors of Record, Healthcare Providers, and any others should follow the steps below to report PQCs or AEs and to obtain instructions to return the Product.

(1) Collect the following necessary information to report:

  • The name of the Product
  • The date of the incident, if available
  • The date that the complaint was received (i.e. awareness date)
  • Product identification information(s) (e.g. Lot number, NDC number, expiration date etc.)
  • Serialization number on the cartons and/or shipper
  • Defective quantity, total inventory for the lot at the site
  • The name, address, email and phone number of the reporter and the end-user (if different from the reporter and if available)

(2) Collect and report the details and circumstances of the incident or complaint, including but not limited to:

  • Details of any allegations of any adverse drug experience or health safety concerns (e.g. death, severe allergic reactions, serious injury or harm(s) caused by the Product etc.)
  • Document if the end user could not or did not provide any of the above information

(3) All complaints and related information shall be forwarded to the MTPA Medical Information call center no later than one (1) business day of receipt of the information by using the following listed phone:

Tel: 1-888-292-0058

(4) After the complaint and information is filed, MTPA or its representative will advise the Healthcare Provider, Authorized Distributor of Record, and/or other entity as to the return procedures for the Product.

VI. Terms For Product Returns

(A) MTPA will not be responsible for Product that is destroyed by any party other than MTPA’s Authorized Return Goods Vendor and proof of destruction will not be accepted in lieu of an actual return. All eligible Products shipped to MTPA must be shipped in a safe, secure, and reliable manner and in compliance with all applicable federal, state, and local laws, regulations and statutes. All shipments must be accompanied by a complete and accurate debit memo number and other required documentation as set forth in Section V hereof. MTPA is not responsible for shipments lost and/or damaged in transit. MTPA recommends that all customers insure return goods shipments.

(B) MTPA will audit the quantities of return goods and final reimbursement will be based on MTPA’s counts. The returned Products will be reimbursed based upon the actual selling price of such Product less any discounts or chargebacks. If the actual selling price of such Product is not able to be determined, MTPA will determine the reimbursement amount in its sole discretion. If the Healthcare providers initiating the return cannot be determined based on information supplied with the return or upon request, MTPA will deny any credit for the return. All reimbursements due for return goods to non-direct purchasing customers will be issued as a credit through the non-direct purchasing customers current Authorized Distributor of Record. Any credits that are issued by MTPA must be redeemed within six (6) months of issuance; otherwise, the credit may be voided or escheated in accordance with applicable law. If a customer cannot receive a credit via their current Authorized Distributor of Record, then the customer should contact MTPA’s Order/Returns Service at 844-529-8990 to determine an alternate method of reimbursement.

(C) Return goods shipments which are deemed to be outside of this Return Policy will not be returned to the customer and no reimbursement will be issued by MTPA for such Product unless state or local law requires otherwise.

(D) MTPA reserves the right to audit the amounts reimbursed for return goods for a period of up to three (3) years from when the payment or credit was issued. If the audit determines that a customer was paid/credited in excess of the amounts specified per this Return Policy then MTPA will be allowed at its election to either: (i) withhold payments/credits for future return goods, or (ii) invoice the customer for the amount of the return goods overpayment and the customer must make payment within thirty (30) days upon receipt of invoice.

(E) MTPA reserves the right to inspect all authorized returns and a credit memo will only be issued for Product that is returned in accordance with and meets the terms of this Return Policy.

(F) MTPA will only consider authorizing returns for Product that is purchased directly from MTPA or through a MTPA Authorized Distributor of Record. Product that has been purchased from sources outside of the United States or its territories or through unauthorized agents in the US will not be credited or refunded.

(G) MTPA reserves the right to require proof-of-purchase on any item returned for credit or refund.