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MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 1 of 13 REFERENCE NUMBER: MA.PMN.23 REPLACES DOCUMENT: EFFECTIVE DATE: 09/06 RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 IMPORTANT REMINDER This Clinical Policy has been developed by appropriately experienced and licensed health care professionals based on a thorough review and consideration of generally accepted standards of medical practice, peer-reviewed medical literature, government agency/program approval status, and other indicia of medical necessity. 42TU The purpose of this Clinical Policy is to provide a guide to medical necessity. Benefit determinations should be based in all cases on the applicable contract provisions governing plan benefits (“Benefit Plan Contract”) and applicable state and federal requirements, as well as applicable plan-level administrative policies and procedures. To the extent there are any conflicts between this Clinical Policy and the Benefit Plan Contract provisions, the Benefit Plan Contract provisions will control. Clinical policies are intended to be reflective of current scientific research and clinical thinking. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. Description: Buprenorphine is a partial opioid agonist that binds to the mu ( ) receptor, reinitiating opioid activity in the brain producing less euphoria than a full opioid agonist but sufficient activity to suppress withdrawal and cravings. Naloxone is a potent antagonist at mu-opioid receptors and produces opiate withdrawal signs and symptoms when administered parenterally to individuals physically dependent on opioid agonists. The naloxone component is included to discourage diversion and misuse. Naloxone has very limited bioavailability when administered sublingually, as intended. In the absence of an opioid, the antagonist has no effect. Buprenorphine/naloxone tablets and film are generally Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 2 of 13 REFERENCE NUMBER: MA.PMN.23 REPLACES DOCUMENT: EFFECTIVE DATE: 09/06 RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 administered sublingually as a single daily dose in the range of 12 to 16 mg/day of buprenorphine content, when used as initial maintenance therapy after the induction period. Maintenance dosing ranges from 4 to 24 mg per day and depending on the individual. Adjustments in dosage should be in 1/0.5mg or 4/1mg increments. Brand: buprenorphine (Subutex ): 2mg, 8mg sublingual tablets (only generic iscurrently marketed) buprenorphine/naloxone (Suboxone ): Brand Film – Suboxone 12/3mg, 8/2mg, 4/1mg, 2/0.5mg; Brand Tablets – Zubsolv 5.7/1.4mg and 1.4/0.36mg (equivalent to 8/2mg and 2/0.5mg ); Generic Tablets – 8/2mg and 2/0.5mg only P®P P®P FDA Labeled Indications: Buprenorphine HCL: Treatment of opioid dependence, preferred for induction, and for treatment of pregnant women with opioid addiction Suboxone® , Zubosolv® and Bunavil®: Maintenance treatment of opioid dependence. P Criteria for Approval: A. Suboxone® film, when used for the treatment of opioid addiction, does not require prior authorization from CeltiCare Health. The usual dosing of Suboxone® film is 16mg buprenorphoine/day, however quantity limits for Suboxone® film allow for more flexible dosing if necessary, and are as follows: Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 3 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 Suboxone® film dose 2-0.05mg 4-1 mg 8-2 mg 12-3 mg Monthly Quantity Limit 90 per month 90 per month 90 per month 60 per month B. CeltiCare Health may review members who are treated with a dose higher than 16mg buprenorphine/day continuously for more than 6 months, to assure appropriate care is being delivered as defined by standards set by national organizations such as SAMHSA. This review may include a request to review medical records, a peer to peer conversation, or other means as deemed appropriate by CeltiCare Health. C. Requests for other formulations of burprenorphine/naloxone containing products, including Zubsolv® and Bunavil®, will require Prior Authorization, with submission of both a documented intolerance of Suboxone® film AND documentation regarding why the requested formulation is unlikely to cause the same intolerance. The review process documented in Paragraph B above will similarly apply. D. Buprenorphine HCL (generic for discontinued Subutex® ), when used for the induction phase of treatment of opioid addiction, does not require prior authorization from CeltiCare Health. It is expected that the induction phase of treatment will not generally last longer than 7 days. P Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 4 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 E. Buprenorphine HCL (generic for discontinued Subutex® ), when used for the treatment of opioid addiction in women who are pregnant, does not require prior authorization from CeltiCare Health. There will be no quantity limits imposed on the prescribing of Buprenorphine HCL when used as described in this section or the above Paragraph D. F. Requests for any other use of Buprenorphine HCL will require a Prior Authorization review, and will require justification of medical necessity as to why it is to be used in lieu of the preferred Suboxone® film for the treatment of opioid addiction. G. In all cases of prescribing, providers are expected to follow and be able to produce documentation, if requested by CeltiCare Health, of evidence that: I. Member has a diagnosis of opioid dependency II. Provider has a unique X-DEA number and is not treating more than the legally allowed number of buprenorphine utilizing members III. Member is actively involved in a substance abuse treatment program at a level commensurate with their ability to remain sober and stable IV. Provider has performed an episodic review of member specific controlled substance utilization through the Massachusetts Prescription Monitoring Program V. Urine Drug Testing is performed at appropriate intervals, and when necessary as directed by the results of such testing, treatment adjuncts are implemented such as participation in more frequent Urine Drug Testing, participation in an escalated drug treatment program, or other means as supported in medical P Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 5 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 literature. U Approval: No limitation on the duration of use for Suboxone® film P For use in pregnancy, Buprenorphine HCL will be covered for up to two months after delivery. For use in induction, Buprenorphine HCL will be covered for up to 7 days. Initial Approval (other than Suboxone film): 4 P®P months Continued Approval (other than Suboxone U P®P film): 1 year Special Instructions > Patient should not be using CNS depressants including alcohol while on Suboxone / Subutex . P®P P® P > The combination of benzodiazepines and buprenorphine have resulted in Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 6 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 serious adverse effects, up to and including coma and death. Deaths have also been reported in association with coadministration of buprenorphine with other depressants such as alcohol or other CNS depressant drugs. Patient does not exhibit significant untreated psychiatric comorbidity, including suicidal ideation. Induction: Prior to induction, consider the type of opioid dependence (i.e. long or shortacting opioid), the time since last opioid use, and the degree or level of opioid dependence. To avoid precipitating withdrawal, undertake induction with buprenorphine when objective and clear signs of withdrawal are evident. Induction can normally be accomplished over a period of 1 or 2 days. U Switching from tablets to film : Bioavailability of film is slightly greater than that of the 8/1mg and 12/3mg tablets; therefore dosage may need to be adjusted when switching from tablets to film. U U Patients taking heroin or other short-acting opioids: At treatment initiation, administer the dose of buprenorphine at least 4 hours after the patient last used opioids or, preferably, when early signs of withdrawal appear. U Patients taking methadone of other long-acting narcotics: There is little controlled experience with the transfer of methadone-maintained patients to buprenorphine. Available evidence suggests that withdrawal symptoms are possible during induction of buprenorphine treatment. Withdrawal appears more likely in patients maintained on higher doses of methadone (more than 30mg) and when the first buprenorphine dose is administered shortly after the last methadone dose. U Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 7 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 Prescriber Certification: Most practitioners certified to prescribe Suboxone can be located on-line at: http://www.buprenorphine.samhsa.gov/bwns locator/index.html However, a practitioner may choose not to have his/her name listed. Certified prescribers are identified on their DEA licenses with an additional DEA number starting with the letter “X”. Licensing information can be obtained from the local DEA office. Effective July 25, 2005, physicians must include their DATA 2000 waiver ID number on prescriptions for opioid addiction treatment medications. U P®P • • For reference, the DSM-V-TR criteria for Opiate Abuse and Dependence follows. Patient meeting 2-3 of the criteria indicate mild substance use disorder, 4-5 criteria indicate moderate substance use disorder, and 67 indicates severe substance use disorder (APA, 2013). Diagnostic criteria: o Continuing to use opioids despite negative personal consequences o Repeatedly unable to carry out major obligations at work, school, or home due to opioid use o Recurrent use of opioids in physically hazardous situations o Continued use despite persistent or recurring social or interpersonal problems caused or made worse by opioid use o Tolerance (marked increase in amount, marked decrease in effect) o Withdrawal manifesting as either characteristic syndrome or the substance is used to avoid withdrawal o Using greater amounts or using over a longer time period than intended o Persistent desire or unsuccessful efforts to cut down or control opioid use o Spending a lot of time obtaining, using, or recovering from using opioids Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 8 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 o Stopping or reducing important social, occupational, or recreational activities due to opioid use o Consistent use of opioids despite acknowledgment of persistent or recurrent physical or psychological difficulties from using opioids o Craving or a strong desire to use opioids Patients should undergo a screening process to determine their diagnosis, severity of illness, and the selection of the appropriate level of care for rehabilitation counseling. Use of one of the opioid withdrawal scales (COWS, OOWS, or SOWS) to assess a patient's level of withdrawal is encouraged. It is best to use a consistent screening tool for each patient: o Clinical Opioid Withdrawal Scale (COWS): common instrument used by clinicians to assess a patient’s opioid withdrawal severity o Objective Opiate Withdrawal scale (OOWS): contains 13 physically observable signs, rated present or absent, based on a timed period of observation of the patient by a rater o Subjective Opiate Withdrawal Scale (SOWS): 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely) Tapering and discontinuation from Buprenorphine Patient may request to be tapered off of Buprenorphine. Relapse rates are high after discontinuation. Patients should return for maintenance treatment if cravings develop after withdrawal. References: 1. Buprenorphine prescribing information. Accessed October, 2013.. http://bidocs.boehringerCentene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 9 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=rene tnt&folder Path=/Prescribing+Information/PIs/Roxane/ Bupr enorphine+HCl+Sublingual+Tabs/ 10004964 01+Buprenorp hine+HCl+Sublingual+Tabs.pdf 2. Suboxone prescribing information. Accessed October, 2013. http://www.suboxone.com/pdfs/SuboxonePI.pdf 3. Substance Abuse and Mental Health Services Administration. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. 2004 Printing. Accessed October, 2013 http://buprenorphine.samhsa.gov/Bup Guidelines.pdf 4. Suboxone /Subutex drug monographs. Clinical Pharmacology. Accessed October, 2013. Reynaud M , Petit G , Potard D , Courty P . Six deaths linked to concomitant use of buprenorphine and benzodiazepines. Addiction. 1998 Sep;93(9):1385-92. Kintz P . A new series of 13 buprenorphine-related deaths. Clin Biochem. 2002 Oct;35(7):513-6. Lai SH , Yao YJ , Lo DS . A survey of buprenorphine related deaths in Singapore. Forensic Sci Int. 2006 Oct 16;162(1-3):80-6. Epub 2006 Aug 1. Pirnay S , Borron SW , Giudicelli CP , Tourneau J , Baud FJ , Ricordel I . A critical review of the causes of death among post-mortem toxicological investigations: analysis of 34 buprenorphine-associated and 35 methadone-associated deaths. Addiction. 2004 Aug; 99(8):978-88. New Formulations: Suboxone Sublingual Film: The Pharmacist’s Letter 2011: 27(1):P 270109 "DSM-5 Substance Use Disorder." BupPractice. Clinical Tools, Inc. Web. http://www.buppractice.com/node/4621. P®P 33Tu U3 3T P®P 5. P®P 3 3TU U3 3 T 33 TU U33 T 33TU 33TU 6. 3 3TU 33TU U3 3 T U33 T U33T U3 3 T 33TU U33T 33TU U33T 33TU 8. 33TU U3 3 T 33TU 7. U3 3 T 33TU U33T 33TU U33T 33TU U33T 33TU U33T 33TU 33TU U33T 33TU U33T U33T U33T 9. 10. Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 10 of 13 REFERENCE NUMBER: MA.PMN.23 REPLACES DOCUMENT: EFFECTIVE DATE: 09/06 RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 29 Sept. 2014. 11. Buprenorphine Outpatient Outcomes Project: can Suboxone be a viable outpatient option for heroin addiction?.Journal of Community Hospital Internal Medicine Perspectives 2014, 4: 22902 http://dx.doi.org/10.3402/jchimp.v4.22902 12. Clinical Opiate Withdrawal Scale (Flowsheet). Farmington, CT:The National Alliance of Advocates for Buprenorphine Treatment, Farmington CT. 1999. http://www.naabt.org/documents/COWS induction flow s heet.pdf. Accessed September 15, 2014. 13. Ling, W., et al. (2009). Buprenorphine tapering schedule and illicit opioid use. Addiction 104: 256-265. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3150159/ 14. Waller, T. and Rumball, D. (2004) Appendix 18: Objective Opiate Withdrawal Scale (OOWS), in Treating Drinkers and Drug Users in the Community, Blackwell Science Ltd, Oxford, UK. doi: 10.1002/9780470693742.app18 15. Handelsman, L., Cochrane, K. J., Aronson, M. J. Ness, R., Rubinstein K.J., Kanof, P.D. (1987) Two New Rating Scales for Opiate Withdrawal. American Journal of Alcohol Abuse, 13, 293-308. Revision Log Revision Pending P&T Committee Review and Approval Revised item “c” from “Patient followed in a detox program for duration of treatment” to “Patient will be followed in a drug abuse counseling program and will undergo drug monitoring for the duration of treatment”. Date 02/09 02/09 Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 11 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 Revised item “d” from “Approved for induction and detox for a period not to exceed 21 days” to “Suboxone (not Subutex ) can be approved for induction and dose stabilization for a period not to exceed 30 days”. Revised item “e” from “ maintenance 11herapy will then be approved for 3 months” to “ maintenance 11herapy will then be approved for use of Suboxone (not Subutex ) for an initial 3 month period, with submission of a proposed titration schedule with the objective of eventual withdrawal. An additional 3 month period can be approved based on submission of information verifying continued participation in drug abuse counseling and continued drug monitoring”. Added the following note after the Criteria for Approval items: Note: Subutex treatment can be approved during pregnancy. Methadone is the therapy of choice for treatment of opioid addiction in pregnancy. Updated Provider Certification information in the Special Instructions section to reflect current practices. Updated References in accordance with materials used in updating the Guideline. Updated the “FDA Labeled Indications” and “Criteria for Approval” sections. Updated reference section to reflect current literature search. Specified approval timeframes. Removed language for preferred use of methadone in pregnancy. References updated. Specified maximum dosing out to one year. Added random monthly drug screenings to better define drug monitoring. Removed language for preferred use of methadone in pregnancy. Updated Reference section to reflect current literature search and reference documents. Added the following note to Special Instructions: Bioavailability of U U P®P U 02/09 P®P U U 02/09 U P®P P®P 02/09 P®P Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. 02/09 02/09 02/10 02/10 02/11 11/11 11/11 11/11 11/11 11/12 MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 12 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 film is slightly greater than that of the tablets; therefore dosing may need to be adjusted when switching from tablets to film. Added specific language that outlines when Subutex will be approved. Updated reference section to reflect current literature search. Description – separated out the Naloxone information to parallel the Buprenorphine description information; added a wider range of possible maintenance dosing from 4-24mg/day. Brand – included changes in brand and generic strengths and availability. Special Instructions – underlined as heading Switching from tablets to film and separated from the paragraph before it; added 8-12mg doses to the first sentence as it has not been shown in lower doses. Added the following into continued approval criteria” Patients who have met all the initial approval criteria and have had a gap of at least 6 months in therapy will qualify for 1 new 12 month course of treatment.” This was requested by BHCP Updated Reference section to reflect current literature search and reference documents; added date of printing for third reference. Clarified criteria and approval timeframes. Removed Prior authorization requirement for use of preferred agent, Suboxone® film, modified QL for all doses of Suboxone® film, and removed prescribing/coverage duration limits for Suboxone® film. Removed Prior authorization requirement for Buprenorphine HCL when used in pregnant women. Reviewed and no changes made. Annual Review, No Changes 11/13 11/13 11/13 11/13 11/13 08/14 08/15 04/16 03/17 POLICY AND PROCEDURE APPROVAL Pharmacy & Therapeutics Committee: Approval on file V.P., Pharmacy Operations: Approval on file Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person. MEDICAL NECESSITY GUIDELINE DOCUMENT NAME: Buprenorphine DEPARTMENT: Pharmacy HCL and buprenorphine/naloxone combinations PAGE: 13 of 13 REFERENCE NUMBER: MA.PMN.23 EFFECTIVE DATE: 09/06 REPLACES DOCUMENT: RETIRED: REVIEWED: 4/16, 03/17 PRODUCT TYPE: Medicaid REVISED: 02/09, 02/10, 02/11, 11/11, 11/12, 11/13, 08/14,12/14, 8/15 Sr. V.P., Chief Medical Officer: Approval on file Centene Medical Policy Statements represent technical documents developed by the Medical Management Staff. Questions regarding interpretation of these policies for the purposes of benefit coverage should be directed to a Medical Management Staff person.