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Date Printed: June 26, 2017: 01:10 AM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 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® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

09-J1000-31

Original Effective Date: 01/15/11

Reviewed: 5/14/14

Revised: 02/15/16

Subject: Intrathecal Drug Therapy for Long-Term Pain Management

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Dosage/ Administration Position Statement Billing/Coding Reimbursement Program Exceptions Definitions
           
Other References Updates    
           

DESCRIPTION:

Intraspinal (i.e. intrathecal, epidural) drug infusion therapy offers an effective alternative for pain control when spinal-acting analgesics or antispasmodics administered orally or transdermally do not achieve adequate pain control or are associated with unacceptable side effects or toxicities. Implanted intrathecal drug-delivery systems (IDDSs) are used to administer medication into the vicinity of the spinal cord or into the epidural space and requires diffusion of the drug through the dura to produce an effect and exposes the spinal nerve roots to the drug. Evidence in the literature suggests the principal benefit of intraspinal delivery appears to be the reduction in opioid side effects, rather than improved analgesia, although patients have reported improved pain scores in clinical trials. Additionally, intraspinal administration allows a reduction of the amount of the drug administered in comparison to oral or parenteral routes of administration. Although close monitoring is required, titration of the drugs can be performed more rapidly, allowing for more aggressive pain control with reduction of side effects and toxicities.

POSITION STATEMENT:

I. A preliminary trial of intrathecal or epidural administration of opiate or non-opiate analgesics for the treatment of severe, chronic intractable pain conditions of malignant and non-malignant origin meets the definition of medical necessity when ALL of the following criteria are met:

1. The member’s life expectancy is at least 3 months

2. The member has experienced failure of, or has intolerance or contraindications to, an adequate trial (i.e., six weeks or longer) of noninvasive methods of pain control, including systemic opioids administered in adequate doses with a fixed schedule (not PRN)

3. Medical contraindications to implantable devices have been eliminated (e.g., coagulopathies, infection)

Approval Duration: 1 month

II. Permanent intrathecal or epidural administration of opiate or non-opiate analgesics for the treatment of severe, chronic intractable pain conditions of malignant and non-malignant origin meets the definition of medical necessity when BOTH of the following criteria are met:

1. A preliminary trial of intrathecal or epidural administration of opioid drug administration was tolerated and successful as evidenced by acceptable degree of pain relief and improved function (e.g., 50% reduction in pain)

2. All of the criteria for a preliminary trial of intrathecal or epidural administration are met

Approval Duration: 1 year

DOSAGE/ADMINISTRATION:

THIS INFORMATION IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND SHOULD NOT BE USED AS A SOURCE FOR MAKING PRESCRIBING OR OTHER MEDICAL DETERMINATIONS. PROVIDERS SHOULD REFER TO THE MANUFACTURER’S FULL PRESCRIBING INFORMATION FOR DOSAGE GUIDELINES AND OTHER INFORMATION RELATED TO THIS MEDICATION BEFORE MAKING ANY CLINICAL DECISIONS REGARDING ITS USAGE.

Most of the medication concentrations and combinations administered through IDDSs are not commercially available and therefore must be compounded in a pharmacy. Medications used in implantable drug delivery systems may include opioids, local anesthetics, adrenergic agonists, and other agents. First line opioid analgesics include morphine and hydromorphone (Dilaudid®), which have clear support from data and extensive clinical experience.

The second line treatment options may be chosen as first line options in cases where a member has predominantly neuropathic symptoms. Acceptable second line options include hydromorphone or morphine in combination with bupivacaine or clonidine. There is little evidence to support the efficacy of clonidine or bupivacaine as single agents.

Other treatment approaches, which are usually considered third-line include: 1) the combination of morphine, bupivacaine, and clonidine; 2) a switch to an alternative opioid, specifically fentanyl or sufentanil; 3) a combination of an alternative opioid, usually hydromorphone but possibly fentanyl or sufentanil, and one of the non-opioid second-line drugs, specifically bupivacaine or clonidine.

Baclofen has been approved for intrathecal use and is effective for spasticity. There is evidence that it can help when pain is specifically related to spasticity, but evidence that it has a broader analgesic effect is lacking.

The table below indicates recommended intrathecal dosing and maximum concentrations for compounded pain prescriptions.

Recommended Medication Doses and Concentrations for Intrathecal Therapy*

Drug

Standard Vial

Concentration(s)

Maximum Recommended

Compounded Concentration

Max Daily Dose

Baclofen

50 µg/mL, 0.5 mg/mL, 2 mg/mL

2 mg/mL

2 mg

Bupivacaine hydrochloride

0.25%, 0.5%, 0.75%

38 mg/mL

30 mg

Clonidine

100 µg/mL, 500 µg/mL

2 mg/mL

1.5 mg

Fentanyl

50 µg/mL

50 µg/mL

****

Hydromorphone hydrochloride **

1 mg/mL, 2 mg/mL, 4 mg/mL

30 mg/mL

10 mg

Morphine

0.5 mg/mL, 1 mg/mL

30 mg/mL

15 mg

* Adapted from Ghafoor, VL et al, Am J of Health Sys Pharm., 2007

** No preservative-free injection available.

PRECAUTIONS:

Medication errors are a common complication in intrathecal pump drug delivery. Drug refills must be done by trained individuals who are able to accurately assess pain, conduct physical examinations, and assess subtle changes in condition. It is also important that pain management centers must be extremely vigilant about their source of medications.

Dosage adjustments must be conducted in a medically supervised and adequately equipped environment. In addition, close monitoring is recommended when adjusting concentrations of the drug(s).

BILLING/CODING INFORMATION:

The following codes may be used to describe:

HCPCS Coding:

A4220

Refill kit for implantable infusion pump

C1772

Infusion pump, programmable (implantable) [ for outpatient facility services]

C1891

Infusion pump, nonprogrammable, permanent (implantable) [for outpatient facility services]

C2626

Infusion pump, nonprogrammable, temporary (implantable) [for outpatient facility services]

E0782

Infusion pump, implantable, non-programmable (includes all components, e.g., pump, catheter, connectors, etc.

E0783

Infusion pump, implantable, programmable (includes all components, e.g., pump, catheter, connectors, etc.

E0785

Infusion intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement

J0475

Injection, baclofen, 10 mg

J0735

Injection, clonidine hydrochloride, 1 mg

J2274

Injection, morphine sulfate, preservative-free for epidural or intrathecal use, 10 mg

J2278

Injection, ziconotide, 1 mcg

J3490

Miscellaneous drugs

J7999

Compounded drug, not otherwise classified

*NOTE: All compounded prescriptions containing any of the above drugs must be submitted with a J3490 code.

ICD-10 Diagnoses Codes That Support Medical Necessity: (Effective 10/01/15)

G24.01

Drug induced subacute dyskinesia

G24.1

Genetic torsion dystonia

G24.3

Spasmodic torticollis

G24.4

Idiopathic orofacial dystonia

G24.5

Blepharospasm

G24.8

Other dystonia

G24.9

Dystonia, unspecified

G25.89

Other specified extrapyramidal and movement disorders

G80.1

Spastic diplegic cerebral palsy

G80.2

Spastic hemiplegic cerebral palsy

G80.3

Athetoid cerebral palsy

G80.8

Other cerebral palsy

G80.9

Cerebral palsy, unspecified

G81.10

Spastic hemiplegia affecting unspecified side

G81.11

Spastic hemiplegia affecting right dominant side

G81.12

Spastic hemiplegia affecting left dominant side

G89.21

Chronic pain due to trauma

G89.22

Chronic post-thoracotomy pain

G89.28

Other chronic postprocedural pain

G89.3

Neoplasm related pain (acute) (chronic)

R25.0

Abnormal head movements

R25.1

Tremor, unspecified

R25.2

Cramp and spasm

R25.3

Fasciculation

R25.9

Unspecified abnormal involuntary movements

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage Products:

The following National Coverage Determination (NCD) was reviewed on the last guideline revised date: Infusion pumps, (280.14) located at cms.gov.

The following Local Coverage Determination (LCD) was reviewed on the last guideline revised date: Implantable infusion pump for the treatment of chronic intractable pain, (L31254) located at fcso.com.

DEFINITIONS:

Epidural: situated within the spinal canal, on or outside the dura mater (tough membrane surrounding the spinal cord).

Intrathecal: into or within the subarachnoid space of the spinal column.

RELATED GUIDELINES:

Unclassified Codes and Compounded Drug Products, 09-J0000-58

OTHER:

None applicable.

REFERENCES:

  1. Albright AL, Gilmartin R, Swift D, et al. Long-term intrathecal baclofen therapy for severe spasticity of cerebral origin. J Neurosurg. 2003; 98(2):291-295.
  2. Clinical Guidelines for Intraspinal Infusion: Report of an Expert Panel. Journal of Pain and Symptom Management. Vol. 20 No. 2 August 2000.
  3. Deer TR, Smith HS, Burton AW et al. Comprehensive consensus based guidelines on intrathecal drug delivery systems in the treatment of pain cause by cancer pain. Pain Physician 2011;14:E283-E312.
  4. Ghafoor, V.L. et al, Intrathecal Drug Therapy for Long-Term Pain Management. AJHP. Vol. 64, Issue 23, 2447-2461.
  5. Hayek SM, Deer TR, Pope JE et al. Intrathecal therapy for cancer and non-cancer pain. Pain Physician 2011;14:219-48.
  6. Intrathecal Fentanyl for Chronic Nonmalignant Pain, WCB Evidence Based Practice Group, Feb/2005.
  7. Knight, K., et al, Implantable Intrathecal Pumps for Chronic Pain: Highlights and Updates. Croat Med J. 2007 February; 48(1): 22–34.
  8. Smith HS, Deer TR, Staats PS. Intrathecal drug delivery. Pain Physician 2008;11:S89-S104.
  9. Smith TJ, Staats PS, Deer T, et al. Implantable Drug Delivery Systems Study Group. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002; 20(19): 4040-4049.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Pharmacy Policy Committee on 05/14/14.

GUIDELINE UPDATE INFORMATION:

01/15/11

New Medical Coverage Guideline.

10/15/11

Review and revision to guideline; consisting of updating references.

01/01/12

Revision to guideline; consisting of updating coding.

10/15/12

Review and revision to guideline; consisting of updated position statement, dosage and administration and references.

06/15/13

Review and revision to guideline; consisting of revising position statement to include approval duration and updating program exceptions section.

06/15/14

Review and revision to guideline; consisting of reformatting position statement and updating references.

01/01/15

Revision to guideline; consisting of annual HCPCS coding update

07/01/15

Revision to guideline; consisting of coding update.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/16

Annual HCPCS coding update: added code J7999 and deleted code Q9977.

02/15/16

HCPCS coding update.

Date Printed: June 26, 2017: 01:10 AM