L31254-LCD

LCD/NCD Portal

Automated World Health

Local Coverage Determination (LCD) for Implantable Infusion Pump for the

Treatment of Chronic Intractable Pain (L31254)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L31254

LCD Title

Primary Geographic Jurisdiction opens in new window

Implantable Infusion Pump for the Treatment of Chronic Florida Intractable Pain

Contractor's Determination Number 95990

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 09/30/2010

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/01/2012

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determination (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represent quotation from one or more of the following CMS sources: CMS Manual Systems, Publication 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4,

Section 280.14

Indications and Limitations of Coverage and/or Medical Necessity

This local coverage determination (LCD) addresses the use of an implantable infusion pump for treatment of chronic intractable pain and is based on the Medicare National Coverage Determinations (NCD) Manual, Infusion Pumps (Section 280.14).

The implantable infusion pump is a drug delivery system that is used to deliver a solution containing a parenteral drug(s) under continuous or intermittent infusion with a regulated flow rate. Its purpose is to deliver a therapeutic level of a drug to a specific site within the body.

An implantable infusion pump is covered when used to administer opioid drugs (e.g., morphine) intrathecally or epidurally for treatment of severe chronic intractable pain of malignant or nonmalignant origin in patients who have a life expectancy of at least 3 months, and have proven unresponsive to less invasive medical therapy as determined by the following criteria:

• The patient’s history must indicate that he/she would not respond adequately to noninvasive methods of pain control, such as systemic opioids (including attempts to eliminate physical and behavioral abnormalities which may cause an exaggerated reaction to pain); and

• A preliminary trial of intraspinal opioid drug administration must be undertaken with a temporary intrathecal/epidural catheter to substantiate adequately acceptable pain relief and degree of side effects (including effects on the activities of daily living) and patient acceptance.

Determinations may be made on coverage of other uses of implanted infusion pumps if the contractor’s medical staff verifies that:

• The drug is reasonable and necessary for the treatment of the individual patient;

• It is medically necessary that the drug be administered by an implanted infusion pump; and,

• The Food and Drug Administration (FDA)-approved labeling for the pump must specify that the drug being administered and the purpose for which it is administered is an indicated use for the pump.

Additionally, antispasmodic drugs for severe spasticity used concomitantly for treatment of chronic intractable pain must meet the following NCD criteria:

An implantable infusion pump is covered when used to administer anti-spasmodic drugs intrathecally (e.g., baclofen) to treat chronic intractable spasticity in patients who have proven unresponsive to less invasive medical therapy as determined by the following criteria:

As indicated by at least a 6-week trial, the patient cannot be maintained on noninvasive methods of spasm control, such as oral anti-spasmodic drugs, either because these methods fail to control adequately the spasticity or produce intolerable side effects, and prior to pump implantation, the patient must have responded favorably to a trial intrathecal dose of the anti-spasmodic drug.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

ELECTRONIC ANALYSIS OF PROGRAMMABLE, IMPLANTED PUMP FOR INTRATHECAL OR EPIDURAL DRUG 62367 INFUSION (INCLUDES EVALUATION OF RESERVOIR STATUS, ALARM STATUS, DRUG PRESCRIPTION

STATUS); WITHOUT REPROGRAMMING OR REFILL

ELECTRONIC ANALYSIS OF PROGRAMMABLE, IMPLANTED PUMP FOR INTRATHECAL OR EPIDURAL DRUG 62368 INFUSION (INCLUDES EVALUATION OF RESERVOIR STATUS, ALARM STATUS, DRUG PRESCRIPTION

STATUS); WITH REPROGRAMMING

ELECTRONIC ANALYSIS OF PROGRAMMABLE, IMPLANTED PUMP FOR INTRATHECAL OR EPIDURAL DRUG 62369 INFUSION (INCLUDES EVALUATION OF RESERVOIR STATUS, ALARM STATUS, DRUG PRESCRIPTION

STATUS); WITH REPROGRAMMING AND REFILL

ELECTRONIC ANALYSIS OF PROGRAMMABLE, IMPLANTED PUMP FOR INTRATHECAL OR EPIDURAL DRUG 62370 INFUSION (INCLUDES EVALUATION OF RESERVOIR STATUS, ALARM STATUS, DRUG PRESCRIPTION

STATUS); WITH REPROGRAMMING AND REFILL (REQUIRING PHYSICIAN’S SKILL)

REFILLING AND MAINTENANCE OF IMPLANTABLE PUMP OR RESERVOIR FOR DRUG DELIVERY, SPINAL 95990 (INTRATHECAL, EPIDURAL) OR BRAIN (INTRAVENTRICULAR), INCLUDES ELECTRONIC ANALYSIS OF

PUMP, WHEN PERFORMED;

REFILLING AND MAINTENANCE OF IMPLANTABLE PUMP OR RESERVOIR FOR DRUG DELIVERY, SPINAL 95991 (INTRATHECAL, EPIDURAL) OR BRAIN (INTRAVENTRICULAR), INCLUDES ELECTRONIC ANALYSIS OF

PUMP, WHEN PERFORMED; REQUIRING PHYSICIAN’S SKILL

ICD-9 Codes that Support Medical Necessity N/A

XX000 Not Applicable

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the performing provider must clearly indicate the medical necessity of the services being billed as outlined under the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD and made available to First Coast Service Options, Inc. (FCSO) Medicare upon request. In addition, documentation that the service was performed must be included in the patient’s medical record and should be legible. This information is normally found in the history and physical, office/progress notes, and/or procedure report.

All of the CPT codes related to the refilling and maintenance of the pump should be billed and documented on the same claim form along with the procedure code for the drugs that are administered through the pump. It is expected that all of these codes should be billed on the same claim.

Note: See “Coding Guidelines” section of this LCD for coding and billing instructions (e.g., use of unique HCPCS drug code(s) vs. unlisted drug code, reconstituted vs. compounded, etc.).

Appendices

Utilization Guidelines It is expected that these services would be performed as outlined under the indications and limitations of coverage. When services are performed in excess of established parameters, they may be subject

to review for medical necessity.

Sources of Information and Basis for Decision

“Implantable Infusion Pump for Treatment of Chronic Intractable Pain,” Palmetto GBA LCD (01102) L28268.

Cohen, S.P., & Dragovich, A. (2007). Intrathecal Analgesia. Medical Clinics of North America. 91(2), 251-270. Retrieved May 3, 2010 from www.mdconsult.com.

Stearns, L., Boortz-Marx, R., Du Pen, S., Friehs, G., Gordon, M., Halyard, M., Herbst, L., & Kiser, J. (2005). Intrathecal Drug Delivery for the Management of Cancer Pain: A Multidisciplinary Consensus of Best Clinical Practices. The Journal of Supportive Oncology. 3(6), 399-408. Retrieved April 30, 2010 from www.SupportiveOncology.net.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with advisory groups, which includes representatives from numerous societies.

Florida Contractor Advisory Committee meeting 06/12/2010.

Puerto Rico/U.S. Virgin Islands Contractor Advisory Committee meeting 06/17/2010.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 08/16/2010

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2012 Revised Effective Date: 01/01/2012

LCR B2012-016

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. Descriptors revised for CPT codes 62367, 95990 and 95991. In addition, added CPT codes 62369 and 62370. The effective date of this revision is based on date of service.

Revision Number Original

Start Date of CommentPeriod:05/28/2010 Start Date of Notice Period:08/16/2010 Original Effective Date 09/30/2010

LCR B2010-061

August 2010 Update

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

62367 descriptor was changed in Group 1 62368 descriptor was changed in Group 1 95990 descriptor was changed in Group 1 95991 descriptor was changed in Group 1

Reason for Change