Medical Coverage Policy Treatment of Opioid Dependence

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1 Medical Cverage Plicy Treatment f Opiid Dependence Device/Equipment Drug Medical Surgery Test Other Effective Date: 07/05/2011 Plicy Last Updated: 6/3/2008 Prspective review is recmmended/required. Please check the member agreement fr preauthrizatin guidelines. Prspective review is nt required. Nte: This plicy addresses the use f buprenrphine as a maintenance treatment f piate addictin and nt the use f rapid withdrawal regimens. Descriptin: The Fd and Drug Administratin (FDA) has apprved tw frms f buprenrphine, Subutex r Buprenex (buprenrphine hydrchlride) and Subxne (buprenrphine hydrchlride and nalxne hydrchlride in a 4:1 rati), fr the treatment f piate dependence. These drugs treat piate addictin by preventing symptms f withdrawal frm herin r ther piates and thereby reducing addictin behavirs. Federal law (DATA, the Drug Addictin Treatment Act) allws physicians t administer and/r prescribe buprenrphine fr addictin treatment, including a maintenance phase whereby the drug may be utilized indefinitely. The law was intended t create greater access t piid addictin treatment prgrams by facilitating the creatin f a chrt f physician ffice treatment prgrams and an allwance fr prescriptins fr self-administratin f the agents, when clinically apprpriate. In cntrast, methadne maintenance requires facility-based treatment and direct administratin f the drug. The use f these agents in medicatin-assisted treatment f piid addictin is regulated by federal and state statute. Buprenrphine with nalxne (Subxne) is used as an alternative t methadne fr the maintenance treatment f piate addictin. The drug is less rigidly cntrlled than methadne because it has a lwer ptential fr abuse and is less dangerus in an verdse. The intentin f adding nalxne t the frmulatin is t deter misuse. Buprenrphine is pharmaclgically related t mrphine and is a partial piid agnist: It has the same effect n mu-pid receptrs in the brain as des herin r ther piate drugs, but it has a ceiling affect whereby higher dses d nt result in higher effects. Buprenrphine, when used crrectly, reduces r eliminates withdrawal symptms assciated with piid dependence but des prduce the euphria and sedatin caused by herin r ther piates. Hwever, warnings exist that bth frmulatins have the ptential fr abuse and prduces dependence f the piid type. Als, buprenrphine has been assciated with significant respiratry depressin, and several deaths have ccurred when addicts intravenusly misused the drug, usually cncmitantly with benzdiazepines (sedative/hypntics) r ther depressants such as alchl and ther piids. Treatment is cnducted in phases as described belw. Inductin:

2 Patients must be assessed fr piid dependence and apprpriateness fr buprenrphine therapy. Once judged apprpriate, patients may start treatment with buprenrphine alne r buprenrphine with nalxne. As nalxne is an antagnist, withdrawal may be precipitated when it is used. Therefre, patients n higher dses f lng-acting narctics will typically be treated with buprenrphine alne r cnverted t shrt-acting drugs r first underg reductin in dses. They may als experience significant withdrawal regardless f buprenrphine administratin and require symptmatic therapies. Patients are instructed t discntinue their piids and are scheduled t be seen in the ffice at a time when they wuld begin t experience withdrawal symptms. The presence f these symptms is assessed and if present, the buprenrphine is administered usually at a dse f 4 mg (2-8 mg). The patient is bserved fr relief f withdrawal signs and symptms r adverse effects. Symptms are typically relieved in minutes. If cntrlled, the patient is usually bserved lnger and at apprximately 2-4 hurs given a secnd 4 mg dse. Rarely, sme patients with high likelihd f breakthrugh withdrawal are sent hme with a third nighttime dse. The patients are then seen daily t assess whether withdrawal is cntrlled. Dses are adjusted as needed until a stable dse is fund. A dse f nt greater than 16 mg is maintained fr several days befre dsage escalatin t allw steady state equilibratin. Usually the target daily dse is determined r the maximum daily dse is reached by three days and administratin can be changed t nce daily. Stabilizatin: The gal f the stabilizatin phase is t attempt t reach a daily maintenance dse within 1-2 weeks. Patients started n buprenrphine withut nalxne are cnverted t the cmbined prduct. Dses greater than 32 mg are nt generally needed. Patients are regularly assessed fr adherence, use f illicit drugs, intxicatin r withdrawal and satisfactin. A Treatment Imprvement Prtcl guidelines (TIP 40) recmmend that initial and nging drug screening shuld be used t detect r cnfirm the use f recent use f drugs which culd cmplicate patient management. Urine screening is the mst cmmnly used testing methd. Maintenance Therapy: Once stable, patients enter maintenance therapy, which may last indefinitely. It may be assciated with gradual dse reductins (medical withdrawal) and eventual eliminatin f treatment, r there may be an indefinite cntinuance t avid relapse f addictin. Dsage and Administratin f Subxne: Subxne treatment is intended fr use in adults and adlescents mre than 16 years f age and is administered sublingually as a single daily dse. The recmmended target dse is in the range f 12 t 16 mg/day. The pill is placed underneath the tngue until it has fully disslved and typically will be absrbed within minutes. As patients prgress n therapy, the physician may write a prescriptin fr a take-hme supply f the medicatin. Physician Qualificatins: The Drug Addictin Treatment Act (DATA) requires that befre physicians begin prescribing buprenrphine they must ntify the Secretary f Health and Human Services-specifically the Divisin f Pharmaclgic Therapies (DPT) within the Center fr Substance Abuse Treatment (CSAT)-f their intent t treat patients with this prduct. CSAT will in turn ntify the Drug Enfrcement Administratin (DEA) if, and when, the prvider is qualified as required by DATA. Only thse physicians wh have apprval frm the DEA are able t start

3 in-ffice treatment and prvide prescriptins fr nging medicatin. The CSAT maintains an active database t help individuals lcate qualified dctrs. Buprenrphine treatment must be cmbined with cncurrent behaviral therapies and with the prvisin f needed scial services by the primary treating physician. Therefre, qualified physicians must be able t prvide r refer patients fr these services. Only physicians may be qualified in accrdance with DATA. Other prfessinals with prescriptive privileges by state law are nt eligible t be qualified. Drug Testing and Other Cmpliance Mnitring: Peridic testing fr use f ther piates r illicit substances r alchl misuse is expected in the management. Usually urine screening is perfrmed during initial phases f treatment and randmly eight times a year. In rder t be sure patients are nt diverting medicatin, they may be required t reprt at randm intervals t the ffice with their pill supply t be sure it is cnsistent with the prescribed use (i.e., n pills are missing.) Physicians must maintain careful recrds f prescribed dses. (Dispensed dses require exact narctic administratin recrds). Blue Crss & Blue Shield f Rhde Island (BCBSRI) may reprt t the prescribing physician regarding the prescriptin payment histry and assess whether the patient receiving buprenrphine is receiving ther piates. The use f piates t cntrl acute pain may be apprpriate, but such use is very cmplex when used in cnjunctin with subxne due t antagnist affects, tlerance, and risk f ver-dsage. Therefre, patients cncmitantly receiving piates and buprenrphine wuld be unusual when the agents are used in a clinically apprpriate manner. BCBSRI may als mnitr physicians t be sure that they are qualified by CSAT and prescribing in cnfrmance with the regulatins. NOTE TO THE PRESCRIBER: The prescriber is respnsible t adhere t the SAMHSA regulatins fr addictin treatment under the prvisins f the Drug Addictin Treatment Act f 2000 (DATA 2000). The prescriber is respnsible fr cmplying with all assciated state and federal piid treatment and maintenance prtcls as they relate t physician qualificatins, privacy and cnfidentiality f the patient, dispensing and prescribing f buprenrphine prducts, recrd keeping and crdinating treatment with addictin and psychiatric treatment prgrams. Medical Criteria: Office-based treatment f piid dependence requires the fllwing: Diagnsis f piid dependence , , Member has been infrmed n safe and effective alternatives t treatment and has chsen this methd f treatment and understands the ptential risks and benefits, and is willing and able t fllw the treatment plan. Nt dependent n high dses f benzdiazepines r ther central nervus system depressants including alchl. N c-ccurring mental health cnditins that may undermine the ability t participate in treatment. Histry f relapse des nt indicate the need fr a higher level f care. Histry f pr respnse t well-cnducted episdes f buprenrphine treatment. Plicy: Treatment f piid dependence using buprenrphines is cvered when the criteria abve it met.

4 The treating physician must hld ne f the fllwing: A subspecialty bard certificatin in addictin psychiatry frm the American Bard f Psychiatry and Neurlgy; r An addictin certificatin frm the American Sciety f Addictin Medicine (ASAM); r A subspecialty bard certificatin in addictin medicine frm the American Ostepathic Assciatin (AOA);r Has cmpleted mre than 8 hurs f training n the treatment and management f piid dependent patients frm the American Academy f Addictin Psychiatry, the American Medical Assciatin, the American Ostepathic Assciatin, r the American Psychiatric Assciatin; AND Registratin number and unique identificatin number frm the Drug Enfrcement Agency (DEA). Treatment f Opiid Dependence shall cnsist f the fllwing: Assessment and Treatment Planning 1-2 ffice visits. CPT cde (used fr psychiatrist. E&M services i.e will be used by internal medicine and ther nn-psychiatrist medical dctrs. Psychiatrists may als use E&M cdes t reprt treatment during the Assessment and Treatment Planning phase if an E&M is the mst apprpriate cde t be filed fr the services rendered). Inductin 1-2 hur ffice visits. Average frequency and duratin f 3 times/week fr tw weeks CPT cde r Stabilizatin 1-2 ffice visits/week. Average frequency and duratin f 6 times/mnth fr tw mnths. CPT cde = r May use when clinically indicated. Maintenance 1 ffice visit/mnth. CPT cde = Cverage: Physician ffice visits fr pharmaclgic management are cvered as a medical ffice visit service. Substance abuse r mental health services (based upn service cde and diagnsis submitted) are cvered as mental health r substance abuse services when prvided by a mental health prfessinal. Drug testing is cvered as a labratry service. Physician dispensed ral medicatin is nt cvered. (Patients may receive initial dses frm the pharmacy if the prescribing physician determines this t be apprpriate.) Benefits may vary between grups/cntracts. Please refer t the apprpriate Evidence f Cverage, Subscriber Agreement, r Benefit Bklet fr applicable Pharmacy, Behaviral Health, Diagnstic Testing, and Physician Office Visits benefit/cverage. All applicable

5 cinsurances, cpayments, deductibles, and benefit limits will apply t the specific service billed. Reimbursement and Cding: There are n specific CPT cdes fr buprenrphine therapy. Mst reprted services directly related t buprenrphine therapy will be Evaluatin and Management services ( , ) r Pharmaclgic Management (90862) if rendered by a psychiatrist. Initial assessments by psychiatrists may require behaviral health cde (90801). Inductin visits may require prlnged face-t-face visits ( r and ). There is n cde fr use f the ffice during bservatin perids, nly face-t-face time by the physician is used when reprting prlnged services cdes. Therefre, time must be carefully dcumented. Prlnged services cdes require dcumentatin review. BCBSRI des nt cver medicatin management in a grup. Grup therapy services prvided in cnjunctin with Subxne treatment is a cvered benefit when a prfessinal eligible t be a BCBSRI-credentialed clinician is present at the grup meeting. Participating prviders may nt charge members fr cvered services except as permitted fr cpayment, cinsurance, deductibles, and benefit limits. Evaluatin and Management Cdes: , Prlnged Services Diagnsis Cdes: Opiid type dependence, unspecified Opiid type dependence, cntinuus Opiid type dependence, episdic Als knwn as: Subxne Subutex Buprenex Opiid Treatment Related tpics: NA Published: Plicy Update, July 2008 Prvider Update, September 2011 References:

6 1. U.S. Fd and Drug Administratin: Octber 8, FDA Talk Paper:Subutex and Subxne apprved t treat piate dependence. Retrieved 3/5/08 frm 2. Center fr Substance Abuse Treatment (CSAT). Abut Buprenrphine Therapy. Retrieved 3/6/08 frm 3. Natinal Guideline Clearinghuse. Clinical guidelines fr the use f buprenrphine in the treatment f piid addictin. Retrieved 3/24/08 frm 4. McClellan, M.B. JAMA. 2002; 288: 2678.Frm the Fd and Drug Administratin: Tw Drugs fr Opiid Dependence. Retrieved 3/5/08 frm b?maxtshw=&hits=10&hits=10&resultformat=&fulltext=subxne&searchid=1&firstindex=0&resurcety pe=hwcit 5. Vastag, B. JAMA. 2003;290: In-Office Opiate Treatment Nt a Panacea :Physicians Slw t Embrace Therapeutic Optin. Retrieved 3/5/08 frm d=1&firstindex=0&resurcetype=hwcit 6. Kuehn, B.M. JAMA. 2005;294: Office-Based Treatment fr Opiid Addictin Achieving Gals. Retrieved 3/5/08 frm d=1&firstindex=0&resurcetype=hwcit 7. O Cnnr, P.G. JAMA2005;294: Methds f Detxificatin and Their Rle in Treating Patients With Opiid Dependence. Retrieved 3/5/08 frm 8. Fiellin, D.A., et al. New England Jurnal f Medicine.Vl 355: , July 27,2006 N 4. Cunseling plus Buprenrphine Nalxne Maintenance Therapy fr Opiid Dependence. Retrieved 3/5/08 frm 9. CSAT (2004) Clinical Guidelines fr the Use f Buprenrphine in the Treatment f Opiid Addictin (TIP 40). Rckville, MD: Center fr Substance Abuse Treatment, SAMHSA. This medical plicy is made available t yu fr infrmatinal purpses nly. It is nt a guarantee f payment r a substitute fr yur medical judgment in the treatment f yur patients. Benefits and eligibility are determined by the member's subscriber agreement r member certificate and/r the emplyer agreement, and thse dcuments will supersede the prvisins f this medical plicy. Fr infrmatin n member-specific benefits, call the prvider call center. If yu prvide services t a member which are determined t nt be medically necessary (r in sme cases medically necessary services which are nn-cvered benefits), yu may nt charge the member fr the services unless yu have infrmed the member and they have agreed in writing in

7 advance t cntinue with the treatment at their wn expense. Please refer t yur participatin agreement(s) fr the applicable prvisins. This plicy is current at the time f publicatin; hwever, medical practices, technlgy, and knwledge are cnstantly changing. BCBSRI reserves the right t review and revise this plicy fr any reasn and at any time, with r withut ntice.

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