BlueCross and BlueShield of Montana Medical Policy/Codes
Opioid Antagonists Under Heavy Sedation or General Anesthesia as a Technique of Opioid Detoxification
Chapter: Mental Health
Current Effective Date: August 27, 2013
Original Effective Date: August 27, 2013
Publish Date: May 27, 2013
Description

The traditional treatment of opioid addiction involves substituting the opiate (i.e., heroin) with an equivalent dose of a longer acting opioid antagonist, (i.e., methadone), followed by tapering to a maintenance dose.  Methadone maintenance therapy does not resolve opioid addiction, but has been shown to result in improved general health, retention of patients in treatment, and a decrease in the risk of transmitting HIV or hepatitis.  However, critics of methadone maintenance point out that this strategy substitutes one drug of dependence for the indefinite use of another.

Detoxification followed by abstinence is another treatment option, which can be used as the initial treatment of opioid addiction, or offered as a final treatment strategy for patients on methadone maintenance.  Detoxification is associated with acute symptoms followed by a longer period of protracted symptoms (i.e., six months) of withdrawal.  Although typically not life threatening, acute detoxification symptoms include irritability, anxiety, apprehension, muscular and abdominal pains, chills, nausea, diarrhea, yawning, lacrimation, sweating, sneezing, rhinorrhea, general weakness, and insomnia.  Protracted withdrawal symptoms include a general feeling of reduced well being and drug craving.  Relapse is common during this period.

Detoxification may be initiated with tapering doses of methadone or buprenophrine (an opioid agonist-antagonist), treatment with a combination of buprenophrine and naloxene (an opioid antagonist), or discontinuation of opioids and administration of oral clonidine and other medications to relieve acute symptoms.  However, no matter what type of patient support and oral medications are offered, detoxification is associated with patient discomfort, and many patients may be unwilling to attempt detoxification.  In addition, detoxification is only the first stage of treatment.  Without ongoing medication and psychosocial support after detoxification, the probability is low that any detoxification procedure alone will result in lasting abstinence. Opioid antagonists, such as naltrexone, may also be used as maintenance therapy to reduce drug craving and thus reduce the risk of relapse.

Dissatisfaction with current approaches to detoxification has led to interest in using relatively high doses of opioid antagonists, such as naltrexone, naloxene, or nalmefene under deep sedation with benzodiazepine or general anesthesia.  This strategy has been referred to as "ultra-rapid," "anesthesia assisted,"or "one-day" detoxification.  The use of opioid antagonists accelerates the acute phase of detoxification, which can be completed within 24–48 hours.  Since the patient is under anesthesia, the patient has no discomfort or memory of the symptoms of acute withdrawal. Various other drugs are also administered to control acute withdrawal symptoms, such as clonidine (to attenuate sympathetic and hemodynamic effects of withdrawal), ondansetron (to control nausea and vomiting), and somatostatin (to control diarrhea).  Hospital admission is required if general anesthesia is used.  If heavy sedation is used, the program can potentially be offered on an outpatient basis.  Initial detoxification is then followed by ongoing support for the protracted symptoms of withdrawal.  In addition, naltrexone may be continued to discourage relapse.

Ultra-rapid detoxification may be offered by specialized facilities.  Neuraad™ Treatment Centers, Nutmeg Intensive Rehabilitation, and Center for Research and Treatment of Addiction (CITA) are examples.  These programs typically consist of three phases: a comprehensive evaluation, inpatient detoxification under anesthesia, and finally, mandatory post-detoxification care and follow-up.  The program may be offered to patients addicted to opioid or narcotic drugs such as opium, heroin, methadone, morphine, demerol, dilaudid, fentanyl, oxycodone, hydrocodone, or butorphanol.  Once acute detoxification is complete, the opioid antagonist naltrexone is often continued to decrease drug craving, with the hope of reducing the incidence of relapse.

Policy

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers opioid antagonists under heavy sedation or anesthesia experimental, investigational and unproven as a technique for opioid detoxification (i.e., ultra-rapid detoxification).

Federal Mandate

Federal mandate prohibits denial of any drug, device or biological product fully approved by the FDA as investigational for the Federal Employee Program (FEP). In these instances coverage of these FDA-approved technologies are reviewed on the basis of medical necessity alone.

Rationale for Benefit Administration
 
This medical policy was developed through consideration of peer reviewed medical literature, FDA approval status, accepted standards of medical practice in Montana, Technology Evaluation Center evaluations, and the concept of medical necessity. BCBSMT reserves the right to make exceptions to policy that benefit the member when advances in technology or new medical information become available.

The purpose of medical policy is to guide coverage decisions and is not intended to influence treatment decisions. Providers are expected to make treatment decisions based on their medical judgment. Blue Cross and Blue Shield of Montana recognizes the rapidly changing nature of technological development and welcomes provider feedback on all medical policies.

When using this policy to determine whether a service, supply, drug or device will be covered, please note that member contract language will take precedence over medical policy when there is a conflict.

Rationale

Evaluation of the safety and effectiveness of ultra-rapid treatment of opioid withdrawal using sedation or general anesthesia involves consideration of a variety of outcomes.  For example, one might consider the numbers of patients enrolling in detoxification programs.  Many opioid addicts may be fearful of prolonged detoxification programs and thus may only seek treatment in an accelerated detoxification program.  Advocates of ultra-rapid detoxification point out that an increasing enrollment in detoxification programs is itself an important outcome.  In addition, proponents suggest that the procedure is a rapid and painless method of detoxification.  Therefore, an important outcome is the comparison of the duration and severity of withdrawal symptoms associated with ultra-rapid detoxification and other detoxification strategies.

The completion rate of a detoxification program is another possible outcome.  As noted by Scherbaum, up to 30% of patients may drop out of traditional inpatient detoxification programs.  Using sedation or anesthesia, one is assured of 100% completion of detoxification.  However, as is commonly pointed out, detoxification is only the first step in treating opiate addiction, and ultra-rapid detoxification programs may offer different types of long-term follow-up care, based on ongoing psychosocial support with or without additional medication, such as naltrexone. Therefore, the rate of abstinence during both the short-term six-month period of protracted withdrawal symptoms and longer term abstinence are also important outcomes.  For example, traditional methods of withdrawal (i.e., tapering doses of methadone or buprenophrine) require the patient to be in a therapeutic environment for a prolonged period of time, potentially reducing the risk of long-term relapse.

In addition, the success of any detoxification program must be evaluated according to the patient populations treated.  For example, patients addicted to heroin may respond differently than those addicted to oxycodone, and response may vary according to duration of addiction or prior attempts at traditional detoxification.  Also, ultra-fast detoxification may be offered to patients on methadone maintenance, in a final effort to render these patients drug free.  These patients may have been in a therapeutic environment for a prolonged period of time, and may have more stable personal lives than those attempting initial detoxification from heroin use.  However, symptoms associated with methadone withdrawal are thought to be more severe than those associated with heroin or codeine withdrawal.

The major safety considerations regarding ultra-rapid detoxification are the risks associated with general anesthesia in combination with opioid antagonists.  While patients are generally intubated and ventilated, eliminating the risk of choking, intravenous naloxone has been associated with cardiovascular complications such as cardiac arrest and pulmonary edema.  These potential safety issues are particularly important, since opioid withdrawal itself is not associated with life-threatening complications.  In contrast, advocates of ultra-rapid detoxification point out that detoxification is a painful procedure, and that the risk of anesthesia has generally been considered acceptable when used to relieve pain.

Given these considerations, assessment of ultra-rapid opioid detoxification will focus on data reporting the severity and duration of withdrawal symptoms and the short- and long-term outcomes of maintenance of abstinence in distinct populations of patients, based on type and duration of addiction.  Efficacy outcomes will be balanced against the safety considerations of deep sedation or general anesthesia in conjunction with naloxone.

Gowing et al. suggests that most patients experienced moderate withdrawal symptoms lasting a few days post-anesthesia or sedation, including nausea, vomiting, diarrhea, and sleep disturbances.  In addition, withdrawal severity may also be related to the anesthetic used. However, without a controlled trial, no conclusion can be made regarding the duration or severity of withdrawal symptoms compared to other techniques of detoxification.

Most of the studies did not report short- or long-term follow-up of abstinence, and those studies that did include follow-up have reported conflicting results.  For example, Seoane and colleagues reported that 279 of the 300 patients treated were abstinent after one month, while in Cucchia's study of 20 patients, 16 reported some resumption of heroin in the six months following detoxification, with 60% considered to have relapsed.  Albanese assessed relapse at six months in 120 patients.  Relapse data were available for 111 patients; 55% were relapse free.  Without controlled studies in similar populations of patients, no conclusions can be drawn about the relative long-term efficacy of ultra-rapid detoxification compared with other treatment strategies.

A variety of adverse events has been reported in small numbers of patients, including vomiting while under anesthesia or sedation, various cardiac rhythmic disturbances, pulmonary dysfunction, and renal insufficiency.  Vomiting under sedation is particularly worrisome due to the threat of aspiration.  Techniques reported to minimize this risk include intubation, use of prophylactic antibiotics, and the use of medication to diminish the volume of gastric secretions. Several deaths occurring either during anesthesia or immediately afterward have been reported.  Also, deaths subsequent to ultra-rapid detoxification have been reported.  Of particular concern is the fact that the use of opioid antagonists results in loss of tolerance to opioids, rendering the patients susceptible to overdose if the patient returns to his/her pre-detoxification dosage of illicit drugs.

In 2000 the American Society of Addiction Medicine published a public policy statement regarding opiate detoxification under sedation or anesthesia.  This policy statement enumerated a number of positions, with the following two most relevant to this discussion:

"Opioid antagonist agent detoxification under sedation or anesthesia (OADUSA) can be an appropriate withdrawal management intervention for selected patients, provided that such services are performed by adequately trained staff with access to appropriate emergency medical equipment.  Although there is medical literature describing various techniques of OADUSA, more research is needed to better define its role in opioid detoxification.  Further studies of outcomes are needed, including both the safety and efficacy of OADUSA as compared to other opioid detoxification modalities, as well as any differential effects on the long term rehabilitation of opioid addicts.

De Jong and colleagues randomized 272 opioid-dependent patients attending methadone clinics to rapid detoxification without anesthesia (RD) or rapid detoxification with general anesthesia (RD-GA).  All patients were treated for seven days at an addiction treatment center.  The patients randomized to RD-GA received four hours of general anesthesia and the opioid antagonist.  They were monitored another four hours and discharged back to the treatment center. Opioid abstinence was monitored in both groups with urinalysis and the intensity of the signs and symptoms of withdrawal during and after treatment was assessed in both groups using subjective and objective measures.  One month following rapid detoxification 62.8% of the RD-GA patients and 60.0% of the RD group were abstinent from opioids (p=0.71).  No adverse events or complications occurred during RD; however, in the RD-GA group five serious adverse events occurred necessitating hospital admission.  According to subjective reports the RD-GA group experienced more craving and withdrawal distress.  However, the differences were not significant at one week.  The authors also conducted a cost analysis and found that the cost of treatment with general anesthesia was much higher than RD without anesthesia.  Because both treatments showed an equivalent efficacy in this study, the authors concluded that rapid detoxification without general anesthesia is the most cost-effective treatment.

Collins and colleagues randomized heroin-addicted patients to three study arms: rapid detoxification with general anesthesia, buprenorphine followed by naltrexone induction beginning on day two, or clonidine plus a variety of supportive medications for one week followed by naltrexone induction beginning day seven.  Following discharge all patients were treated with naltrexone for 12-weeks and relapse-prevention psychotherapy.  Treatment retention at 12-weeks did not differ significantly across the three groups (20% RD-GA group, 24% buprenorphine group and 9% in the clonidine group).  By week three more than 50% of patients had dropped out of each treatment arm.  Three patients in the RD-GA group experienced life-threatening events immediately following general anesthesia which included pulmonary edema and aspiration pneumonia in one patient, diabetic ketoacidosis in another, and mixed bipolar episode with suicidal ideation that required hospitalization at five days in one patient.  During the outpatient phase, no group differences occurred in number of urine samples positive for opiates. The authors conclude that general anesthesia for rapid detoxification for rapid antagonist induction does not currently have a meaningful role to play in the treatment of opioid dependence.

In April 2006 the Cochrane Review conducted a meta-analysis to update a previous 2002 review. The purpose of the meta-analysis was to assess the effectiveness of interventions involving the administration of opioid antagonists to induce opioid withdrawal with concomitant heavy sedation or anesthesia, in terms of withdrawal signs and symptoms, completion of treatment and adverse effects.  The authors concluded that based on the available evidence, heavy sedation compared to light sedation does not confer additional benefits in terms of less severe withdrawal or increased rates of commencement on naltrexone maintenance treatment.  Given that the adverse events are potentially life-threatening, the value of antagonist-induced withdrawal under heavy sedation or anesthesia is not supported.  The high cost of anesthesia-based approaches, both in monetary terms and use of scarce intensive care resources, suggest that this form of treatment should not be pursued.

Coding

Disclaimer for coding information on Medical Policies

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

94.65, 94.66, 304.00, 304.01, 304.02

Procedural Codes: 90899
References
  1. Seoane, A., Carrasco, G., et al.  Efficacy and safety of two new methods of rapid intravenous detoxification in heroin addicts previously treated without success.  British Journal of Psychiatry (1997) 171:340-5.
  2. Solomont, J.H.  Opiate detoxification under anesthesia.  Journal of the American Medical Association (1997) 278(16):1318-9.
  3. Cucchia, A.T., Monnat, M., et al.  Ultra-rapid opiate detoxification using deep sedation with oral midazolam: short and long-term results.  Drug and Alcohol Dependence (1998) 52(3):243-50.
  4. Gooberman, L.L.  Rapid opioid detoxification.  Journal of the American Medical Association (1998) 279(23):1871-2.
  5. Dyer, C.  Addict died after rapid opiate detoxification.  British Medical Journal (1998) 316(7126):170.
  6. Scherbaum, N., Klein, S., et al.  Alternative strategies of opiate detoxification: evaluation of the so-called ultra-rapid detoxification.  Pharmacopsychiatry (1998) 31(6):205-9.
  7. Brewer C.  Opiate detoxification under anaesthesia.  British Medical Journal (1998) 316(7149):1983-4.
  8. Brewer, C., Laban, M., et al.  Rapid opiate detoxification and naltrexone induction under general anaesthesia and assisted ventilation: experience with 510 patients in four different centres.  Acta Psychiatrica Belgica (1998) 98:181-9.
  9. O'Connor, P.G., and T.R. Kosten.  Rapid and ultrarapid opioid detoxification techniques.  Journal of the American Medical Association (1998) 279(3):229-34.
  10. Bearn, J., Gossop, M., et al.  Rapid opiate detoxification treatments.  Drug and Alcohol Review (1999) 18:75-81.
  11. Gold, C.G., Cullen, D.J., et al.  Rapid opioid detoxification during general anesthesia: a review of 20 patients.  Anesthesiology (1999) 91(6):1639-47.
  12. Kienbaum, P., Scherbaum, N., et al.  Acute detoxification of opioid-addicted patients with naloxone during propofol or methohexital anesthesia: a comparison of withdrawal symptoms, neuroendocrine, metabolic and cardiovascular patterns.  Critical Care Medicine (2000) 28(4):969-76.
  13. Albanese, A.P., Gevirtz, C., et al.  Outcome and six month follow up of patients after Ultra Rapid Opiate Detoxification (UROD).  Journal of Addictive Diseases (2000) 19(2):11-28.
  14. American Society of Addiction Medicine.  Public Policy Statement on Opioid Antagonist Agent Detoxification Under Sedation Or Anesthesia (OADUSA).  Journal of Addictive Disease (2000) 19(4):109-12.
  15. Bovill, J.G.  Opioid detoxification under anesthesia.  European Journal of Anaesthesiology (2000) 17(11):657-61.
  16. Hensel, M., and W.J. Kox.  Safety, efficacy and long-term results of a modified version of rapid opiate detoxification under general anesthesia: a prospective study in methadone, heroin, codeine and morphine addicts.  Acta Anaesthesiology Scandinavica (2000) 44(3):326-33.
  17. Gowing, L., Ali, R., et al.  Opioid antagonists under heavy sedation or anaesthesia for opioid withdrawal.  The Cochrane Library, (2002) (2) CD002025.
  18. Collins, E.D., Kleber, H.D., et al.  Anesthesia-assisted vs buprenorphine- or clonidine-assisted heroin detoxification and naltrexone induction: a randomized trial.  Journal of the American Medical Association (2005) 294(8):903-13.
  19. De Jong, C.A., Laheij, J.F., et al.  General anesthesia does not improve outcome in opioid antagonist detoxification treatment: a randomized controlled trial.  Addiction (2005)100:206-15
  20. Favrat, B., Zimmermann, G., et al.  Opioid antagonist detoxification under anaesthesia versus traditional clonidine detoxification combined with an additional week of psychosocial support: a randomized clinical trial.  Drug and Alcohol Dependence (2006) 81(2):109-16.
  21. Gowing, L., Ali, R., et al.  Opioid antagonists under heavy sedation or anaesthesia for opioid withdrawal.  Cochrane Database Systems Review (2006) (2):CD002022.
  22. Opioid Antagonists under Heavy Sedation or General Anesthesia as a Technique of Opioid Detoxification.  Chicago, Illinois:  Blue Cross Blue Shield Association Medical Policy Reference Manual (2006 December) Mental Health 3.01.02.
History
May 2013  New 2013 BCBSMT medical policy.  Opioid antagonists under heavy sedation or anesthesia are considered experimental, investigational and unproven as a technique for opioid detoxification (i.e., ultra-rapid detoxification). 
BCBSMT Home
®Registered marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. ®LIVE SMART. LIVE HEALTHY. is a registered mark of BCBSMT, an independent licensee of the Blue Cross and Blue Shield Association, serving the residents and businesses of Montana.
CPT codes, descriptions and material only are copyrighted by the American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS Restrictions Apply to Government Use. CPT only © American Medical Association.
Opioid Antagonists Under Heavy Sedation or General Anesthesia as a Technique of Opioid Detoxification