OCREVUS Start Form. Instructions for Patients. Instructions for Health Care Providers
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- Maude Sharp
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1 Instructions for Patients By completing this form: You will enroll in support services from Genentech You can apply to the Genentech Access to Care Foundation (GATCF) to determine if you are eligible to receive Genentech medicine free of charge You will consent to the use and disclosure of some of your personally identifiable information (PII), including health information. We will only disclose the information necessary to provide the services you have requested We can start assisting you once this form is sent back to us by you or your health care provider on your behalf. You can choose not to sign this form. However, please note that we cannot assist you without your signed authorization. To obtain assistance, please follow these steps: 1. Read the Patient Authorization Information describing Genentech patient support services on Pages 2 and If you wish to enroll in OCREVUS Access Solutions, please fill in SECTION 1 and sign and date SECTION 1A on Page If you wish to enroll in additional educational and marketing programs, please sign and date SECTION 1B on Page If you wish to determine if you are eligible for GATCF, please complete SECTION 1C on Page Your health care provider will fill out Page 5 of the Start Form and send the form back to us. Be sure to fill in all information, complete all required fields (*) and sign and date the form or it could delay our ability to help you. If you have any questions, talk to your health care provider or contact OCREVUS Access Solutions Call: (800) Visit: Genentech-Access.com/OCREVUS Instructions for Health Care Providers Please write legibly and complete all required fields (*) on the OCREVUS Start Form to prevent delays. To enroll your patient, please follow these steps: By completing this form, you are requesting services on behalf of your patient, which may include: Benefits investigation Benefits reverification approximately 6 weeks prior to patient s next treatment date Infusion site identification Assistance with the prior authorization process and appeals resources Referral to co-pay support options or Genentech Access to Care Foundation (GATCF) services (please check the appropriate boxes on behalf of your patient) You may opt out of any of these services for your patient by contacting OCREVUS CONNECTS at (844) Have your patient read the Patient Authorization Information describing Genentech patient services on Pages 2 and Have your patient read, sign and date SECTION 1A on Page 4. Your patient should sign and date SECTIONS 1B and 1C on Page 4 if they would like to request additional services listed on Page Complete Page 5 and sign and date the Physician Certification. 4. This form cannot be processed without an original signature and date from both the prescriber and the patient. 5. Fax Pages 4 and 5 of the Start Form to (877) Diagnosis Code and Clinical Information Enter the diagnosis code to the highest level of specificity Infusion Site Location Check the appropriate box to indicate the need for assistance with infusion site identification Page 1 of 5
2 Patient Authorization Information Authorization to Share Personally Identifiable Information (PII) and Patient Services Authorization Please read the following carefully. If you agree, sign and date SECTION 1A of the Start Form. Information That May Be Used or Disclosed By signing this Authorization, I am directing my health care provider and health care plan(s) to share certain personally identifiable information (PII) with Genentech and/or the Genentech Access to Care Foundation (GATCF). This PII may include: Health information related to my treatment with Genentech products, including relevant diagnoses and prescriptions Information about my health care plan benefits, including my deductibles and anticipated annual and lifetime out-of-pocket costs Who May See and Use My PII I authorize Genentech and/or GATCF to use and further disclose my PII to others who are assisting Genentech and/or GATCF; and to my health care provider(s), health care entities, pharmacies and health plan(s) for the purpose of facilitating my access to Genentech products and providing the services described below: Coordinating with my health care plan to understand coverage for Genentech products Applying to GATCF Determining my eligibility for financial assistance services, including co-pay assistance Coordinating fulfillment and facilitation of my prescription through a pharmacy, infusion site and/or health care provider s office Providing treatment reminders and education OCREVUS Access Solutions and GATCF administrative purposes I authorize Genentech, GATCF and companies working with Genentech, to use my PII in connection with these services and to contact me in relation to these services by mail, , fax, telephone call or text message. By providing my phone number, I authorize Genentech to use auto-dialers, prerecorded messages, and artificial voice messages to contact me. I understand that these calls/texts may mention the name of Genentech products or services, details about my insurance coverage and my doctor s name. I understand that I am not required to consent to being contacted by phone or text message as a condition of any purchase of Genentech products or enrollment in OCREVUS Access Solutions or GATCF. Notices This Authorization shall be in effect for 3 years from the date of my signature or the date of last enrollment, whichever comes first, unless a shorter period is required by law. I understand that if I am a resident of the state of Maryland, this Authorization will be valid for no longer than 1 year from the date I signed it. Once I sign this Authorization form and my PII is transmitted to Genentech and/or GATCF, I understand that the Health Insurance Portability and Accountability Act (HIPAA) may no longer protect the PII disclosed to Genentech and/or GATCF by my health care provider or others covered by the HIPAA laws because Genentech and GATCF are not covered by HIPAA. I understand that Genentech and GATCF are committed to protecting my information and keeping it secure and confidential while it is being collected or used to assist me and that the use and disclosure of my information will be limited to that described above. I understand that I can refuse to sign this Authorization form. I also understand that I can cancel this Authorization at any time and for any reason. I understand that this cancellation means that Genentech and/or GATCF will no longer use or share my PII, but does not apply to PII already used or shared. To cancel this Authorization, I must send a written notice to Genentech. It can be sent by fax or by mail to the address on this page. If I cancel this Authorization, I understand that Genentech and GATCF will no longer be able to assist me with access to my Genentech products. (continued on next page) Page 2 of 5
3 Notices (continued) The address for Genentech Access Solutions and GATCF is 1 DNA Way, Mail Stop #858a, South San Francisco, CA The fax number for Genentech Access Solutions and GATCF is (877) I understand that I, as the patient or signer, have a right to obtain a copy of this signed Authorization form during the period it is in effect. Product Acceptance If I receive free medicine from GATCF, I will not sell or distribute Genentech products. I understand it is unlawful to do this. I am responsible for ensuring any Genentech product is sent to a secure address when it is shipped to me. I know it is my duty to control any Genentech product while it stays in my possession. Additional Educational Communications and Marketing Authorization Please read the following carefully. If you agree, sign and date SECTION 1B of the Start Form. I want to enroll in optional and free programs sponsored by Genentech, related to the use of Genentech products. These programs may include information or materials about co-pay assistance or other patient support programs, providing me with information or marketing materials about Genentech products or services available from Genentech and its affiliates, or opportunities to participate in surveys or provide feedback. I understand my personally identifiable information (PII), including information about my use of Genentech products, may be needed for me to be a part of these programs. I understand by enrolling in these programs, Genentech may share information concerning my health with those who are responsible for administering these programs. I may choose to be contacted by mail, , phone and/or text message. I understand the use and disclosure of my PII will be limited to Genentech, its successors, and its Agents, except as required by law. I agree to let Genentech, its successors, or its Agents contact me in the future about these programs. I understand the following: This consent to enroll in these programs or receive marketing information is voluntary, I can get assistance from Genentech even if I do not sign this consent, I can get my medicine even if I do not sign this consent, and I may cancel my enrollment or consent to marketing at any time. To cancel, I can call (844) toll free. By checking one or more of the boxes in SECTION 1 to receive voice messages and/or text messages, I authorize Genentech to use auto-dialers, prerecorded messages, and artificial voice messages to contact me. I understand that these voice calls and text messages may market or advertise Genentech products, goods or services. I understand that I am not required to consent to being contacted by phone or text message as a condition of any purchase of goods or services. Financial Information Attestation (Complete only if you would like to apply for support from GATCF) Please read the following carefully. If you agree, sign and date SECTION 1C of the Start Form. I understand that to qualify for free medicine, GATCF has criteria that must be met, including income. I certify the statement of my total annual household income for the previous calendar year is true, and I do not have the financial resources or insurance coverage to pay for OCREVUS. I know that GATCF could ask me for a copy of my IRS 1040 form or other proof of income for the purpose of an audit. I agree to provide my financial documentation in a timely manner, if so requested. In addition, I will notify GATCF immediately if my insurance situation changes. Please note that GATCF will pursue all appropriate legal remedies, including seeking damages in litigation, in the event GATCF determines that this certification is false or that the financial attestation is false or inaccurate. By signing this attestation, I certify that the statement of my annual household income amount is true and accurate, to the best of my knowledge. Page 3 of 5
4 PLEASE DO NOT SEND ANY ADDITIONAL DOCUMENTATION. Required field (*) Patient Authorization and Notice of Request for Transmission of Health Information to Genentech and Genentech Access to Care Foundation (PAN) To Be Filled Out By Patient SECTION 1: Patient Information Date of Birth* (MM/DD/YYYY) Preferred form of communication (check all that apply) Home phone: ( ) - Cell phone: ( ) - OK to leave detailed message? Yes No OK to send a text message? Yes No Best time to reach me: Morning Afternoon Patient preferred language Alternate contact name Relationship to Patient 1A: Authorization to Share Personally Identifiable Information (PII) and Patient Services Authorization* [required to obtain support services from Genentech] I have read and understand the Authorization on Pages 2 and 3 and agree to the terms. Sign and date here Signature of Patient/Authorized Person* Print name of person signing (if not the patient) Relationship to Patient Date signed* 1B: Additional Educational Communications and Marketing Authorization I have read and understand the Authorization terms and conditions on Page 3 and agree to the use of my Personally Identifiable Information for the purposes of the programs described on Page 3. Choose to enroll by signing and dating here Signature of Patient/Authorized Person Date signed 1C: For Genentech Access to Care Foundation Only: Financial Information Attestation I am seeking support from GATCF and have read and understand the Attestation terms and conditions on Page 3. I certify that the income information below is true and accurate, to the best of my knowledge. Total household income for previous calendar year $ Choose to enroll by signing and dating here Signature of Patient/Authorized Person Date signed Page 4 of 5
5 PLEASE DO NOT SEND ANY ADDITIONAL DOCUMENTATION. Required field (*) Statement of Medical Necessity (SMN) To Be Filled Out by Health Care Provider SECTION 2: Patient Information DO NOT CONTACT PATIENT SECTION 5: Infusion Site Location Yes, please provide assistance locating infusion site Date of Birth* (MM/DD/YYYY) Street Gender: Male Female City Please coordinate with: Prescriber to identify infusion site Patient to identify infusion site If applicable, please list preferred infusion site below. No, please do not provide assistance locating infusion site Patient will be infused at: Prescriber's office (SECTION 4) A separate, preferred infusion site (please list below) State* ZIP * PREFERRED INFUSION SITE INFORMATION SECTION 3: Insurance Information NO INSURANCE Preferred infusion site name Primary insurance name Infusion site tax ID # Subscriber name Infusion site NPI # Subscriber/Policy ID # Street Suite # Group # City State ZIP Secondary insurance name Fax Subscriber name Subscriber/Policy ID # Group # SECTION 4: Prescriber Information Practice name* Street* Suite # SECTION 6: Forward to Specialty Pharmacy (SP) for Fulfillment SP: Yes No Preferred SP: Ship to: Prescribing physician's office (SECTION 4) Preferred infusion site (SECTION 5) Other address: SECTION 7: Diagnosis Code and Clinical Information Diagnosis code*: G35 Multiple Sclerosis (MS) Relapsing Forms of MS (RMS) Primary Progressive MS (PPMS) Other diagnosis code: Has the patient started prescribed OCREVUS (ocrelizumab)? Yes No Current/most recent MS therapy: City* State* ZIP* Prescriber tax ID # Prescriber NPI # OCREVUS PRESCRIPTION Initial Dose: Initial dose SIG: Dispense Instructions: 300-mg vials Refills: Group NPI # Office contact name Subsequent Dose: Subsequent dose SIG: Dispense Office contact phone Fax Instructions: 300-mg vials Refills: BY COMPLETING THIS FORM, I am requesting services on behalf of the patient, which may include benefits investigation and reverification, help navigating the prior authorization process and appeals support. Refer Patient to Co-pay Assistance GATCF Patient Assistance PHYSICIAN CERTIFICATION: By signing below, I certify: (a) the above therapy is medically necessary, (b) I received the authorization to release the information above and other protected health information (as defined by the Health Insurance Portability and Accountability Act of 1996 [HIPAA]) to Genentech, Inc., Genentech Access Solutions, the contracted dispensing pharmacy, infusion site of care or other contractors for the purpose of requesting reimbursement support, assisting in initiating or continuing therapy and/or the evaluation of the patient s eligibility for GATCF, as a break in treatment would negatively impact the patient s therapeutic outcome and (c) I will not attempt to seek reimbursement for free product provided directly to the patient or an alternative site of care. I request Genentech Access Solutions convey to the pharmacy or alternative site of administration chosen by the above-named patient the prescription described herein. I agree to comply with the Genentech, Inc. program guidelines and understand that Genentech and GATCF, at its sole discretion, reserves the right to modify or discontinue the program at any time and to verify the accuracy of the information submitted. I further understand that Genentech will provide vial replacement in a configuration that will create the least wastage. If applying for GATCF, I certify that (a) this patient has no medical insurance coverage or otherwise meets the financial criteria for the prescribed therapy, and is not eligible for other product financial support programs, and (b) the therapy identified above will not be used in a clinical trial. Note: Prescribers in all states must follow applicable law for a valid prescription and who is considered an authorized prescriber. For prescribers in states with official prescription form requirements, such as New York, please submit prescriptions on an official state prescription blank along with this form. Unapproved Use Warning: Please read the FDA-approved label for Genentech products before prescribing. If the indication for which you are prescribing a Genentech product is not listed in the FDA-approved label, you are prescribing the medication for an unapproved use, meaning that the FDA has not approved the efficacy, dosage amount or safety of this medication when used for such a use. Nevertheless, GATCF will consider providing the medication for your patient with this admonition, based upon your medical order, within program requirements. Sign and date here Prescriber s Signature*: Date*: / / (Original signature required. This form cannot be processed without an original signature.) National Provider Identifier. Genentech Access to Care Foundation. OCREVUS, its logo and the Access Solutions logo are registered trademarks of Genentech, Inc Genentech USA, Inc. So. San Francisco, CA All rights reserved. Printed in USA Page 5 of 5
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