Complete Claim Package Requirements. (A) A complete Claim Package must include the following “Supporting Documentation”:
(1) A completed and signed Claim Form contained in Appendix E-1;
(2) A completed and signed Authorization to Release Records and Other Information contained in Appendix E-2. When executing this document, the Program Participant shall not specify particular healthcare providers for the collection of records, but shall leave the provider field of the form blank so that it may be utilized for collection of any necessary records in accordance with Section 4.06;
(3) An executed Release contained in Appendix F-1;
(4) In the event of a Plaintiff who asserts a Derivative Claim in the Complaint filed by the Program Participant, an executed Release contained in Appendix F-2, instead of an executed Release contained in Appendix F-1, executed by the Program Participant and by any Plaintiff who asserts a Derivative Claim in the Complaint filed by the Program Participant. For avoidance of doubt, a Release is required from each and every Plaintiff who asserts a Derivative Claim with respect to any Program Participant, but a Release is not required from the spouse of a Plaintiff if the spouse did not assert a Derivative Claim in the Complaint;
(5) Contemporaneous prescription records from a pharmacy or medical facility reflecting that the Program Participant was prescribed or provided with NuvaRing, or other substantiating evidence (the “Prescription Records”), it being understood that: (i) “contemporaneous prescription records” refers to records that were created at, or about, the time the prescription was written or NuvaRing provided, and (ii) “other substantiating evidence” may include an affidavit by a healthcare professional attesting to the prescription of NuvaRing; documentation of samples of NuvaRing that were provided to the Program Participant; documentation in hospital records for the Alleged Injury that specifically reference NuvaRing, or such similar evidence that would be admissible in a state or federal court proceeding to establish the Program Participant’s usage of NuvaRing;
Complete Claim Package Requirements. (A) A complete Claim Package must include the following “Supporting Documentation”:
(1) A completed Claim Form contained in Appendix H, executed by Personal Signature, to include the Program Participant’s election of Injury Level;
(2) A complete but undated Authorization to Release Records and Other Information contained in Appendix I, executed by Personal Signature. When executing this document, the Program Participant shall not specify particular healthcare providers for the collection of records, but shall leave the provider field of the form blank so that it may be utilized for collection of any necessary records in accordance with the audit provisions set forth in Section 8.05;
(3) The following “Core Medical Records,” certified by the Program Participant as Complete or unavailable. If any of the following Core Medical Records are unavailable, a certified No Records Statement from the pertinent provider must be included in the Claim Package.
i. Records of Bladder Cancer diagnosis, to include:
1. A pathology report finding the existence of cancerous cells in the urothelial lining of the urinary bladder, the renal pelvis or the ureter; or
2. If it is determined by the Claims Administrator or the Eligibility Committee, as applicable, that no pathology report is available, despite diligent efforts by the Program Participant to obtain it, provision of other contemporaneous medical records referencing a pathology report containing a diagnosis of Bladder Cancer that, in both instances, are determined by the Claims Administrator or Eligibility Committee, as applicable, to be sufficient to establish a diagnosis of Bladder Cancer.
ii. Proof of ACTOS Products usage, to include:
1. Contemporaneous Prescription Records from all pharmacies that dispensed ACTOS Products to the Product User for the period spanning first alleged use of ACTOS Products through the last use of ACTOS Products or June 1, 2012, whichever is earlier; and
2. Contemporaneous Medical Records documenting Product User’s usage of ACTOS Products.
iii. Complete medical records from all healthcare providers who:
1. diagnosed the Product User’s Bladder Cancer; and/or
2. provided treatment for the Product User’s Bladder Cancer.
iv. If not otherwise included in the above-listed records, medical records from all healthcare providers who prescribed ACTOS Products to the Product User, for the period spanning first alleged use of ACTOS Products through the last use of ACTOS products.
v. If not otherwise inc...
