9/9/2016. Drug Name (select from list of drugs shown) Bunavail Buccal Film (buprenorphinenaloxone) Suboxone Sublingual Film (buprenorphine-naloxone)

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1 9/9/2016 Prior Authorization Form PASSPORT HEALTH PLAN KENTUCKY MEDICAID Buprenorphine Products This fax machine is located in a secure location as required by HIPAA regulations. Complete/review information, sign and date. Fax signed forms to CVS/Caremark at Please contact CVS/Caremark at with questions regarding the prior authorization process. When conditions are met, we will authorize the coverage of Buprenorphine Products. Drug Name (select from list of drugs shown) Bunavail Buccal Film (buprenorphinenaloxone) Suboxone Sublingual Film (buprenorphine-naloxone) Buprenorphine SL Tablet Subutex Sublingual Tablet (buprenorphine) Buprenorphine-Naloxone SL Tablet Zubsolv Sublingual Tablet (buprenorphine-naloxone) Quantity Frequency Strength Route of Administration Expected Length of Therapy Patient Information Patient Name: Patient ID: Patient Group No.: Patient DOB: Patient Phone: Prescribing Physician Physician Name: Physician Phone: Physician Fax: Physician Address: City, State, Zip: Diagnosis: ICD Code: Comments: Please circle the appropriate answer for each question. 1. Is the request for reauthorization of a previously approved prior authorization through Passport? [If yes, then skip to question 27.] 2. Is the patient 16 years of age or older? 3. Has the prescriber been issued an "X" DEA license number to prescribe buprenorphine-containing products for the treatment of opioid dependence? 4. Did the prescriber utilize one of the following diagnostic and/or screening tools: A) Diagnostic and Statistical Manual of Mental Disorders, B) DAST, C) COWS Assessment? Please indicate which tool was utilized in screening. 5. Has the prescriber obtained and reviewed a KASPER report (or equivalent report if out of state) for the patient for the twelve (12)

2 month period immediately preceding the initial patient encounter? Please submit documentation indicating date and request number. [Note: We cannot request an actual copy of a Kasper] 6. Has the prescriber performed and documented a drug screen? Please document date of drug screen and results. 7. Does the patient have any untreated or unstable psychiatric conditions that would interfere with compliance to a buprenorphine-containing product? [If no, then skip to question 9.] 8. Is the psychiatric conditions stabilized and/or treated? 9. Has the patient had an emergency department visit or inpatient hospitalization due to medical/psychiatric complication of opioid use (i.e., infection, acute suicidal ideation, etc.)? Please list approximate date(s) and medical/psychiatric complication(s) addressed. 10. Is the patient receiving professional substance abuse disorder counseling? Please submit the name of the licensed professional or organization. [Note: A 12-step program ALONE is considered social support and not professional counseling.] 11. Have the risks and benefits of using buprenorphine-containing products been explained to the patient along with the risks of using these products with alcohol or benzodiazepines? 12. Have the prescriber AND patient signed the Passport Health Plan Statement of Understanding Form - Taking Buprenorphine- Containing Products or an equivalent form? Please submit documentation of the following "Statement of Understanding Form - Taking Buprenorphine-Containing Products" has been reviewed with the patient, signed by the patient and the prescriber, and attached to the request or the prescriber's version of the form must be signed by the patient and prescriber. The Plan allows for the prescriber to submit a form with the member's signature noted per phone. 13. Is the patient 55 years of age or older? [If yes, then skip to question 19.] 14. Is the patient female and of childbearing age? [If no, then skip to question 19.] 15. Has the patient been given a pregnancy test and been counseled regarding the risks of becoming pregnant while on this medication, including the risk of neonatal abstinence syndrome (NAS)? 16. Is the request for Subutex or buprenorphine? [If no, then skip to question 21.] 17. Is the patient pregnant or breastfeeding? [If no, then skip to question 19.] 18. Is the buprenorphine being prescribed by or in consultation with another physician who is certified by the American Board of

3 Addiction Medicine, the American Board of Medical Specialties (ABMS) in psychiatry, or an American Osteopathic Association (AOA) certifying board in addiction medicine or psychiatry OR from an obstetrician or maternal-fetal medicine specialist who is also qualified to prescribe Buprenorphine? Please list approximate date(s) and name of physician consulted. [If yes, then skip to question 21.] 19. Is the request for Subutex or buprenorphine? [If no, then skip to question 21.] 20. Does the patient have a documented (through MedWatch) allergy to naloxone? 21. Is the request for Bunavail, Brand Subutex or Zubsolv? [If no, then skip to question 26.] 22. Is the patient unable to take the preferred formulary alternatives for the given diagnosis due to a documented allergy, intolerance, or contraindication? [If yes, then skip to question 26.] 23. Has the patient had a documented therapeutic failure to a trial of at least ONE preferred medications within the same class? 24. Does the requested medication have a corresponding generic that is covered by the plan? [If no, then skip to question 26.] 25. Has the patient had a therapeutic failure to a trial of the corresponding generic of the requested medication? 26. Is the request for Subutex, buprenorphine, Suboxone film, greater than 16mg per day, buprenorphine/naloxone greater than 16mg per day, Bunavail greater than 8.4mg per day, or Zubsolv greater than 11.4mg per day? [No further questions.] 27. Does the claims history confirm consistent use of a buprenorphine-containing product since the previous authorization? [If yes, then skip to question 29.] 28. Has a written explanation as to why the buprenorphine-containing product should be continued despite apparent noncompliance been submitted? 29. Has the patient been on a buprenorphine-containing product for 12 months or longer? [If no, then skip to question 34.] 30. Does the prescriber attest that at least 8 drug screens will or have been performed within each 12 month period? Prescriber must document dates and attach results from last twelve (12) months. Dates: 31. Have all drug screens been positive for buprenorphine or buprenorphine metabolite (i.e., norbuprenorphine)? Please list date(s) and attach results from last 12 months. [If yes, then skip to question 33.] 32. Has a written explanation as to why the drug screens were negative for buprenorphine or norbuprenorphine been submitted?

4 Please submit documentation including an explanation of these negative results. 33. Were at least TWO drug screens within each 12 month period random and coupled with a pill count? Please submit documentation listing date(s) and attach results from last 12 months. 34. Are the drug screens that are negative for unauthorized opiates since the last authorization including dates of drug screens documented in the patient's chart? Please submit documentation listing date(s) and attach results from last 12 months. [Note: rep to verify via pharmacy claims data that the patient has not filled unauthorized opioids.] [If yes, then skip to question 36.] 35. Is it documented in the patient's chart the approximate date of relapse and how the relapse was managed? Please submit documentation including the approximate date and how the relapse was managed. 36. Does the patient have any untreated or unstable psychiatric conditions that would interfere with compliance to a buprenorphine-containing product? [If yes, then no further questions.] 37. Is the patient receiving professional substance abuse disorder counseling? Please submit documentation listing the name of the licensed professional or organization. [Note: A 12-step program ALONE is considered social support and not professional counseling.] 38. Has the prescriber performed monthly KASPER reports (or equivalent report if out of state) and certifies that they show no unauthorized opioid fills? Please submit date and request number. [Note: We cannot request an actual copy of a Kasper.] [If yes, then skip to question 40.] 39. Is the prescriber an out-of-state prescriber and cannot provide a KASPER report? [Note: Inform provider subsequent requests would require a KASPER report.] [No further questions.] 40. Is the request for Subutex, buprenorphine, Suboxone film, greater than 16mg per day, buprenorphine/naloxone greater than 16mg per day, Bunavail greater than 8.4mg per day, or Zubsolv greater than 11.4mg per day? I affirm that the information given on this form is true and accurate as of this date. Prescriber (Or Authorized) Signature and Date

5 Statement of Understanding Form Taking Buprenorphine-Containing Products I, [insert name], have talked to my provider about taking buprenorphine-containing medicines. I understand and agree to the following: I have decided to take this medicine to help treat my addiction to narcotic drugs. I know from talking to my provider that there are risks and possible side effects linked to taking this medicine. I agree to follow the therapy as ordered by my provider. I have had the chance to ask questions about this product, other treatment options, and the risks of treatment. I have enough information to understand my treatment. I will tell my provider who is prescribing this medicine about any other provider or dentist appointments. I will tell my provider about any prescription and non-prescription medicines I am taking. I have been given a copy of this Statement of Understanding Form. To help make my treatment a success, I agree to: Go to all of my follow-up visits. Take any alcohol or drug tests my provider orders. I know from talking with my provider that it is unsafe to mix this medicine with alcohol and other drugs. Store my medicine in a safe place. I will not share my medicine with anyone. I know it can be unsafe for others. Take this medicine as ordered by my provider. To get the most benefit from the medicine, I will not skip any doses. I have been told how to take this medicine. I will place it under my tongue to dissolve (melt) and be absorbed. Get my prescriptions for this medicine only from the provider/provider group listed on this agreement. Go to counseling as part of treating my addiction. By signing here, I agree to ALL of the bullet points on this form. Signature: Date: Prescriber s Signature: _ Date: PROV40935 APP_2/12/2015

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