Electroconvulsive Therapy (ECT)

Easy Choice Health Plan, Inc.

Harmony Health Plan of Illinois, Inc.

Missouri Care, Inc.

‘Ohana Health Plan, a plan offered by WellCare Health Insurance of Arizona, Inc.

WellCare Health Insurance of Illinois, Inc.

WellCare Health Plans of New Jersey, Inc.

WellCare Health Insurance of Arizona, Inc.

WellCare of Florida, Inc.

WellCare of Connecticut, Inc.

WellCare of Georgia, Inc.

WellCare of Kentucky, Inc.

WellCare of Louisiana, Inc.

WellCare of New York, Inc.

WellCare of South Carolina, Inc.

WellCare of Texas, Inc.

WellCare Prescription Insurance, Inc.

Windsor Health Plan for Medicare Advantage Part D Windsor Rx Medicare Prescription Drug Plan

Electroconvulsive Therapy (ECT)

Policy Number: HS-070 Original Effective Date: 12/18/2008

Revised Date(s): 12/22/2009;

12/28/2010; 12/1/2011; 12/6/2012;

12/5/2013; 4/3/2014; 4/2/2015

APPLICATION STATEMENT

The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any.

DISCLAIMER

The Clinical Coverage Guideline is intended to supplement certain standard WellCare benefit plans. The terms of a member’s particular Benefit Plan, Evidence of Coverage, Certificate of Coverage, etc., may differ significantly from this Coverage Position. For example, a member’s benefit plan may contain specific exclusions related to the topic addressed in this Clinical Coverage Guideline. When a conflict exists between the two documents, the Member’s Benefit Plan always supersedes the information contained in the Clinical Coverage Guideline. Additionally, Clinical Coverage Guidelines relate exclusively to the administration of health benefit plans and are NOT recommendations for treatment, nor should they be used as treatment guidelines. The application of the Clinical Coverage Guideline is subject to the benefit determinations set forth by the Centers for Medicare and Medicaid Services (CMS) National and Local Coverage Determinations and state-specific Medicaid mandates, if any. Note: The lines of business (LOB) are subject to change without notice; consult www.wellcare.com/Providers/CCGs for list of current LOBs.

BACKGROUND

Electroconvulsive Therapy (ECT) has been used to treat depression since the 1930s, and it is used commonly today to treat patients who have treatment-resistant depression (TRD), mania or acute schizophrenia. ECT is administered by delivering electrical current to the brain through the scalp and skull, in either a unilateral or bilateral manner, to induce a generalized seizure. Although the mechanism of action is not completely understood, the efficacy of ECT for the above indications has been demonstrated in a large number of clinical trials. A recent review and meta- analysis found that real ECT was significantly more effective than simulated ECT (six trials, 256 patients), and treatment with ECT was significantly more effective than pharmacotherapy (18 trials, 1144 patients) [2]. In this same analysis bilateral ECT was more effective than unipolar ECT (22 trials, 1408 participants). Patients often require continued maintenance treatments and significant side effects such as memory loss are associated with ECT.

Despite the potential side effects, in studies the conclusion has been that ECT is more valuable than just the intervention of last resort. In comparison with psychotropic medications, ECT can act more effectively and more rapidly, with substantial clinical improvement that is often seen after only a few treatments. This is especially true for severely ill patients—those with severe major depression with psychotic features, acute mania with psychotic features, or catatonia. For patients who are physically debilitated, elderly, or pregnant, ECT is also safer than psychotropic medications. ECT is a major treatment in psychiatry with well-defined indications. It should not be reserved for use only as a “last resort”. The likely speed and efficacy of ECT are factors that influence its use as a primary intervention. Particularly in major depression and acute mania, substantial clinical improvement often occurs soon after the start of ECT. When a rapid or a higher probability of response is needed, as when patients are

severely medically ill or at risk to harm themselves or others, primary use of ECT should be considered. Other considerations for the first-line use of ECT involve the patient’s medical status, treatment history, and treatment preference. The best response to ECT in this population is noted when the duration of illness from initial onset is short; when psychotic symptoms in the present episode have an abrupt or recent onset; with catatonia present; or when there has been a favorable response to ECT in the past.

The primary indication for ECT is major depressive disorder. ECT is usually considered when medications fail, cannot be tolerated, or may be dangerous, but it is a first-line treatment for severely depressed patients who require a rapid response because of a high suicide or homicide risk, extreme agitation, life-threatening inanition, psychosis, or stupor. The average course of treatment for depression is 6 to 12 treatments, but some patients may require as many as 20 treatments. ECT has been found to be as or more effective than lithium in the treatment of manic episodes and is also a potential treatment for patients experiencing mixed episodes. ECT is generally reserved for those patients with bipolar disorder who are unable to safely wait until a medication becomes effective, who are not responsive to or unable to safely tolerate one of the effective medications, is preferred by the patient in consultation with the psychiatrist, or who have had a good response to ECT in the past. The number of ECT treatments reported to be effective for mania has ranged from 8 to 20.

ECT is not effective for chronic schizophrenia. However, ECT may be effective for psychotic schizophrenic

exacerbations when affective symptomatology is prominent, in catatonic schizophrenia, and when there is a history of a prior favorable response to ECT. Schizophrenia may require 17 or more ECT treatments. A small number of ECT treatments often reverse catatonia, a nonspecific symptom that can occur in mood disorders, schizophrenia, cognitive disorders, and medical and neurological illnesses. Up to 12 treatments may be required in some patients.

The most common use of ECT is with patients who have not responded to other treatments. During the course of pharmacotherapy, lack of clinical response, intolerance of side effects, deterioration in the psychiatric condition, or the appearance of suicidality are reasons to consider the use of ECT.

ECT is usually considered for psychotic patients who have not responded to trials of medications. An adequate trial of medication is defined in various ways by various sources including:

 6 weeks at a therapeutic dose;

 6 to 8 weeks of antidepressant treatment at a therapeutic dosage;

 4 to 6 weeks as a key threshold for deciding whether to continue the medication trial after which if a patient does not respond consider switching to a different treatment; and

 Assuming that some improvement is shown, at 8 to 12 weeks is an adequate trial.

Lack of treatment response to at least two adequate trials of appropriate pharmacological agents accompanied by other appropriate treatment modalities may indicate consideration of ECT as a treatment alternative. ECT may be considered earlier in cases where an adequate trial is not possible because of the patient’s inability to tolerate the pharmacological treatment, is incapacitated to the extent they cannot take medication safely, or waiting for a positive response to pharmacological treatment may endanger the patient’s life.

POSITION STATEMENT

Applicable To:

Medicaid Medicare

Electroconvulsive Therapy (ECT) is considered medically necessary when ANY of the following are indicated:

 Depression with acute suicide risk, extreme agitation, or unresponsive to pharmacological therapy; OR,

 Intolerance to the side effects of antidepressant medication or to antidepressant or psychotropic medications that pose a particular medical risk; OR,

 When rapid resolution of depression is necessary (e.g., the member is acutely suicidal or physically compromised, and the time factor to achieve maximal effectiveness of antidepressants or mood stabilizers places the member at immediate risk to health or safety; OR,

 Inability to medically tolerate maintenance medication; OR,

 Catatonia ; OR,

 Acute schizophrenia, life-threatening psychosis, which have not responded to, or cannot be treated with short term, high dose tranquilization; OR,

 Mania, where medications are ineffective or not tolerated, or severe mania presenting a safety risk to the member or to others; OR,

 When continuation of ECT treatments is necessary to sustain remission or to sustain significant improvement.

ECT is considered NOT medically necessary for the following conditions:

 Alcoholism (303.00 – 303.93) as the primary diagnosis; OR,

 To aid in developing conditioned aversions to the taste, smell, and sight of alcoholic beverages; OR,

 Ability to tolerate effective antidepressant or psychotropic medications, and rapid resolution of depression is unnecessary because the member is not at immediate risk of suicide; OR,

 No evidence of ECT effectiveness in members who have been treated previously; OR,

 Responsiveness to mood stabilizers; OR,

 Life-threatening psychoses responsive to short-term high dose tranquilization; OR,

 No evidence of catatonia, acute schizophrenia, mania, acute suicide risk, or extreme agitation; OR,

 Depression with ability to tolerate and respond to antidepressant medications.

Multiple-seizure electroconvulsive therapy (MECT) is considered experimental and investigational and NOT a covered benefit.

Informed Consent, Equipment and Physician Requirements

Written informed consent administered by the physician, is required to be given by the member. Informed consent must detail the procedure and possible side effects. If informed consent cannot be given due to incompetence or

physical limitations of the member, a court order must be applied to initiate consent. Consent is valid for 30 days.

 All ECT equipment must be registered with the proper authorities.

 Physicians who perform the procedure must have extensive experience delivering ECT and must be properly trained in informed consent procedures.

 Two physicians are required to state that the procedure is medically necessary for individuals > 65 years.

Contraindications for Use

There are no absolute medical contraindications to ECT. It is more pertinent to think in terms of degree of risk relative to potential benefits of ECT. There are some specific conditions that may be associated with substantially increased risk. These are:

 Unstable or severe cardiovascular conditions such as recent myocardial infarction, congestive heart failure, and severe valvular cardiac disease.

 Aneurysm or vascular malformation that might be susceptible to rupture with increased blood pressure.

 Increased intracranial pressure, as may occur with some brain tumors or other space-occupying lesions.

 Recent cerebral infarction.

 Pulmonary conditions such as severe chronic obstructive pulmonary disease, asthma, or pneumonia.

 Anesthetic risk rated as ASA level 4 or 5.

Specific Considerations

Concurrent Medical Illness: The decision to administer ECT should include consideration of the anticipated effects of the patient’s medical status, including present medical treatments, upon the risks and benefits of ECT. The pre- ECT evaluation of medical conditions should include lab tests and specialist consultation when indicated to minimize potential adverse side effects. The existence and implications of conditions associated with significantly increased risk should be taken into account during the informed consent process. The ECT procedure should be modified when indicated to lower morbidity or augment efficacy. Such modifications may include changing ECT technique, altering pharmacologic regimes, administering ECT in a different hospital or clinic location, and utilizing additional medical specialists or monitoring procedures.

Elderly Patients: ECT may be used with elderly regardless of age. Efficacy does not diminish with age, and may be enhanced. Clinical experience suggests that among the elderly, ECT may have less risk of complications than some forms of pharmacotherapy. Dosages of medications for pre-ECT may need to be modified based on the

physiological changes associated with aging. ECT stimulus intensity should be selected with an awareness that seizure threshold generally increases with age. Decisions regarding ECT should be guided by the possibility that ECT-induced cognitive dysfunction may be greater in elderly adult patients. ECT technique should be modified to minimize adverse cognitive effects when necessary.

Pregnancy: ECT may be used in all three trimesters of pregnancy as long as an obstetric consultation is attained and concurs. The risks of anesthetic agents to the fetus are likely to be less that those of pharmacologic alternatives.

Nonetheless, potential teratogenic effects and neonatal toxicities should be discussed in the informed consent process. When the gestational age is over 10 weeks, noninvasive monitoring of fetal heart rate should be done before and after each ECT treatment. If the pregnancy is high risk or near term, the presence of an obstetrician and/or additional monitoring may be indicated at the time of ECT treatment. At facilities administering ECT to pregnant women, resources for managing obstetrical and neonatal emergencies should be readily accessible.

Children and Adolescents: ECT is a psychiatric intervention rarely indicated in the treatment of adolescents. ECT should be considered as an option for a seriously ill adolescent who has failed to respond to other treatment efforts.

There is very limited data or clinical experience in the use of ECT in preadolescent children, and its use in this population should be carefully considered. ECT should be discussed in detail with both parents and patient during the informed consent process, clarifying risks and benefits involved in the treatment. A second opinion should be obtained from a psychiatrist who is knowledgeable about ECT and not directly responsible for the treatment of the

patient. This second opinion should concur with the recommendation for ECT prior to proceeding. Qualified personnel experienced in treating children and adolescents should administer anesthesia.

Adverse Side Effects

 Cardiovascular Complications: The electrocardiogram and vital signs should be monitored during each ECT treatment to detect hypertension and arrhythmias;

 Prolonged Seizures;

 Prolonged Apnea;

 Systemic Side Effects such as headache and nausea are the most common systemic side effects of ECT;

 Treatment Emergent Mania such as Instances in which patients switch from depressive states into

hypomania or mania during a course of ECT should be identified, and a determination made regarding the need to continue or suspend further ECT treatment; and

 Cognitive Dysfunction may result in the need for orientation and memory function to be assessed prior to each ECT; member should be periodically assessed while undergoing treatment to monitor for ECT-related cognitive dysfunction.

Use of Medical and Psychotropic Medications During ECT

All medications should be reviewed as part of the pre-ECT evaluation. In general, it is advisable to discontinue or reduce the dose of most psychotropic agents prior to ECT, although this should not prevent the institution of ECT treatment in a timely fashion. This is especially true for medications that may increase morbidity or decrease efficacy of ECT (i.e. benzodiazepines and most sedative hypnotics, anticonvulsants, lithium). Patients on anti- depressants may continue the course of therapy, as co-administration of moderate doses of antidepressant is unlikely to contribute substantially to morbidity. There may even be a synergistic effect with the co-administration of

antipsychotic medication and ECT. The medications administered before ECT on treatment days should be clearly specified.

Location of Treatment

ECT may be administered on either an inpatient or outpatient basis. The determination of the location of ECT will depend on a number of factors, including patient preference, and should be viewed as a dynamic ongoing process throughout the ECT course. In making this decision, the same indications, relative contraindications, consent requirements, and components of the pre-ECT evaluation hold for both inpatient and ambulatory ECT:

 The inpatient setting should be used whenever the patient’s psychiatric condition precludes safe and effective management on an outpatient basis.

 For consideration of ambulatory ECT, there must be available an identified support system to assist in compliance with the treatment protocols and the ability to provide transportation.

There should be an ongoing assessment of the patient’s ability to change treatment settings as appropriate.

Frequency and Number of Treatments

ECT is most commonly performed at a schedule of three times per week. Some practitioners may use increased frequencies of ECT to speed the recovery, particularly in cases of severe symptom presentation; however, prolonged use of daily treatments is usually associated with increased cognitive impairments. There is no justification for the use of more intense regimens. A reduction in the frequency of treatment should be considered if severe cognitive dysfunction or delirium develops.

The total number of treatments administered should be a function of both the degree and rate of clinical

improvement and the severity of the cognitive adverse side effects. The evaluation of the response should focus on the target symptoms, with assessment made between each treatment. The treatment course should terminate as soon as it is evident that maximal improvement has been reached. While the typical ECT course in patients with a mood disorder is between 6-12 treatments, some patients manifest complete remission after only a few treatments.

Other patients may not show substantial clinical improvement until they have received 10 or more treatments. In the absence of significant clinical improvement after 6-10 treatments, the indication for continued ECT should be reassessed. Consideration may be given to modification of the ECT technique, the use of medications to potentate the clinical response, or discontinuation of the ECT. There is no evidence that repeated courses of ECT lead to permanent structural damage, or that a maximum limit on lifetime number of treatments with ECT is appropriate.

Maintenance ECT should be administered at the minimum frequency compatible with sustained remission, often at 1-3 week intervals. The need for continued maintenance ECT should be reassessed at least every three months. All completed ECT requests must be approved by a WellCare psychiatrist. Upon initial approval, 6 sessions of ECT will be allowed. All ECT requests must include an initial and secondary MD consultation and medical clearance including:

 Psychiatrist review for: psychiatric history and examination to determine the indication for ECT, including previous response to ECT if pertinent;

 A medical evaluation to define risk factors;

 Psychiatric review for a second opinion of medical necessity by an individual privileged to administer ECT with a note in the clinical record summarizing the indications and potential risks for the specific patient;

 Anesthetic evaluation, addressing the nature and extent of the anesthetic risk;

 Informed consent-policies and procedures should be developed to assure proper informed consent, including when, how, and from whom the consent is to be obtained;

 Appropriate laboratory and diagnostic tests including a hematocrit, serum potassium, and EKG; and

 Consideration should be given to performing a pregnancy test in women of childbearing age before ECT.

CODING

Covered CPT®* Codes

90870 Electroconvulsive Therapy (ECT), includes necessary monitoring

00104 Anesthesia for electroconvulsive therapy anesthesia is limited to one time unit (fifteen minutes).

Anesthesia Modifiers Claims must be billed with one of the following modifiers for anesthesia services:

AA Anesthesia services performed personally by anesthesiologist

AD Medical direction by a physician; more than four concurrent procedures

QK Medical direction; two, three, or four concurrent anesthesia procedures involving qualified Individuals QS Monitored anesthesia care service

QY Medical direction of one CRNA by anesthesiologist QX CRNA service – with medical direction by a physician QZ CRNA service – without medical direction by a physician HCPCS Code - No specific codes

ICD-9-CM Procedure Code

94.27 Electroconvulsive Therapy (ECT)

DRAFT 2014 ICD-10-PCS Codes

GZB0ZZZ Electroconvulsive therapy, unilateral-single seizure GZB1ZZZ Electroconvulsive therapy, unilateral-multiple seizure GZB2ZZZ Electroconvulsive therapy, bilateral-single seizure GZB3ZZZ Electroconvulsive therapy, bilateral-multiple seizure GZB4ZZZ Other electroconvulsive therapy

Covered ICD-9-CM Diagnosis Codes

291.0 – 294.9 Organic psychotic conditions 295.00 – 295.85 Schizophrenic disorders

296.00 – 296.84 Bipolar I and Bipolar II Disorders, Manic-Depressive 311 Depressive disorder not elsewhere classified

Non-Covered ICD-9-CM Diagnosis Codes

303.00 – 303.93 Alcohol Dependence syndrome Covered ICD-10-CM Diagnosis Codes

F20.0 - F29 Schizoaffective disorders F30.10 - F30.9 Manic episode

F31.10 - F31.64 Bipolar disorder F31.81 - F31.89 Other bipolar disorders F31.9 Bipolar disorder, unspecified

F32.0 - F32.3 Major depressive disorder, single episode F32.8 Other depressive episodes

F32.9 Major depressive disorder, single episode, unspecified F33.0 - F33.3 Major depressive disorder, recurrent

F33.8 Other recurrent depressive disorders

F33.9 Major depressive disorder, recurrent, unspecified

Non-Covered ICD-10-CM Diagnosis Codes

F10.220-F10.229, F10.20-F10.21 Alcohol dependence with intoxication

*Current Procedural Terminology (CPT®) ©2015 American Medical Association: Chicago, IL.

REFERENCES

1. Dougherty, D.D., & Rauch, S.L. (2007). Somatic therapies for treatment-resistant depression: new neurotherapeutic interventions.

Psychiatric Clinics of North America, 30, 31-37.

2. American Psychiatric Association. (2003). Practice Guideline for the assessment and treatment of patients with suicidal behaviors. Retrieved from http://www.psychiatryonline.com/pracGuide/pracGuideChapToc_14.aspx

3. American Psychiatric Association. (2002). Practice guideline for the treatment of patients with bipolar disorder (revision). Retrieved from http://www.psychiatryonline.com/pracGuide/pracGuideChapToc_8.aspx

4. American Psychiatric Association. (2010). Practice guideline for the treatment of patients with major depressive disorder (3^rd ed.). Retrieved from http://www.psychiatryonline.com/pracGuide/pracGuideChapToc_7.aspx

5. Centers for Medicare and Medicaid Services. (2003, April 1). National coverage determination (NCD): multiple electroconvulsive therapy (MECT) (160.25). Retrieved from http://www.cms.hhs.gov/mcd/search.asp

6. Institute for Clinical Systems Improvement. (2011). Major depression in adults in primary care. Retrieved from http://www.icsi.org/depression_5/depression__major__in_adults_in_primary_care_3.html.

7. National Institute for Clinical Excellence. (2003). Guidance on the use of electroconvulsive therapy. Retrieved from http://www.nice.org.uk/nicemedia/pdf/59ectfullguidance.pdf

MEDICAL POLICY COMMITTEE HISTORY AND REVISIONS

Date Action

4/2/2015,  Approved by MPC. No changes.

4/3/2014  Approved by MPC. Inclusion of additional items in the Position Statement re: ECT.

12/5/2013, 12/6/2012  Approved by MPC. No changes.

12/1/2011  Approved by MPC. Reformatted references; added most recent revision of APA reference. New template design approved by MPC.