L31225-LCD

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Local Coverage Determination (LCD) for Qutenza® (capsaicin) 8% patch (L31225)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09101

Contractor Type MAC - Part A

LCD Information

Document Information

LCD ID Number L31225

LCD Title

Qutenza® (capsaicin) 8% patch

Contractor's Determination Number AQutenza®

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

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 01/01/2011 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:

Change Request 6996, Transmittal 1980, dated June 4, 2010, July 2010 Update of the Hospital Outpatient Prospective Payment System (OPPS)

Indications and Limitations of Coverage and/or Medical Necessity

Shingles or herpes zoster rash is a painful viral infection caused by a reactivation of the varicella-zoster virus (human herpesvirus, type 3) that causes chickenpox. Postherpetic neuralgia (PHN) is a rare, painful complication of shingles, a result of nerve damage caused by the shingles virus. The pain can persist long after the shingles rash clears up and can disrupt sleep, mood, work, and the person’s activities of daily living.

Qutenza ® (capsaicin) 8% patch is a TRPV1 channel agonist approved by the Food and Drug Administration (FDA) for the management of neuropathic pain associated with PHN. The active ingredient in Qutenza ® is a synthetic form of capsaicin, the substance in chili peppers that gives them their heat sensation. Qutenza ® harnesses the power of capsaicin in a localized dermal delivery system and has the following characteristics:

• Qutenza ® is a single, 1 hour, localized treatment that can provide prolonged pain relief and should not be applied more frequently than every 12-weeks, as warranted by the return of pain

• Qutenza ® is a non-narcotic therapy option that may be used alone or in combination with other PHN treatments.

• Qutenza ® contains high concentration capsaicin in a localized dermal delivery system that targets the nerve endings in the skin.

• Application of the patch can be quite painful, requiring use of a local topical anesthetic, as well as additional pain relief such as ice or use of opioid pain relievers

For safe and proper administration, only physicians or healthcare professionals under the close supervision of a physician are to administer Qutenza ®. The following warnings and precautions should be followed:

• Qutenza ® should not be applied to the face or scalp to avoid risk of exposure to the eyes or mucous membranes.

• The patient’s blood pressure should be monitored during and following treatment with Qutenza ®.

• Patients with unstable or poorly controlled hypertension, a recent history of cardiovascular or cerebrovascular events may be at an increased risk of adverse cardiovascular effects.

• Inhalation of airborn capsaicin can result in coughing or sneezing.

Indications:

First Coast Service Options, Inc. (FCSO) Medicare will cover Qutenza ® (capsaicin) 8% patch for the FDA approved indication of neuropathic pain associated with PHN when all the following conditions are met:

• The patient has a diagnosis of painful PHN.

• The patient is having moderate to severe neuropathic pain below the head in one or more areas due to PHN.

• The patient has intact and unbroken skin with good perfusion over the painful area(s).

Limitations:

FCSO Medicare will not cover Qutenza ® (capsaicin) 8% patch for the FDA indication of neuropathic pain associated with PHN if any of the following conditions are present:

• The patient has hypertension that is not adequately controlled with medication.

• The patient has significant ongoing or untreated abnormalities in cardiac, renal, hepatic, or pulmonary function that may put the patient at risk of adverse effects with treatment of Qutenza ® (capsaicin) 8% patch.

• The patient has hypersensitivity to capsaicin (i.e., chili peppers or over-the counter [OTC] capsaicin products), local anesthetics, or adhesives.

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.

013x Hospital Outpatient 085x Critical Access Hospital

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.

0636 Pharmacy - Drugs Requiring Detailed Coding

CPT/HCPCS Codes

J7335 CAPSAICIN 8% PATCH, PER 10 SQUARE CENTIMETERS

ICD-9 Codes that Support Medical Necessity

053.10 HERPES ZOSTER WITH UNSPECIFIED NERVOUS SYSTEM COMPLICATION

053.13 POSTHERPETIC POLYNEUROPATHY

53.19 HERPES ZOSTER WITH OTHER NERVOUS SYSTEM COMPLICATIONS

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

It is expected that this service is performed within the parameters of acceptable standards of medical practice as outlined in the FDA label for approved indication, application, and precautions. Medical record documentation must support the medical necessity for this service, the area(s) treated, as well as pre and post condition of the

patient. This documentation must be made available to Medicare upon request.

Appendices

Utilization Guidelines Distribution of Qutenza® is through a network of specialty pharmacies and specialty distributors to limit the possibility that this product would be dispensed to a patient for self-administration. Qutenza® will be sent directly to sites of care, such as physicians’ offices and hospital outpatient clinics, where it can be appropriately applied. Given its administration requirements, it is expected that Qutenza® would be administered by pain specialists in their offices. However, other qualified specialties who may be managing the patient’s pain may administer this treatment when all the criteria under the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD are met.

Qutenza® (capsaicin) 8% patch may not be applied more frequently than every 3 months, and only when warranted by the return of PHN pain as outlined under the “Indications and Limitations of Coverage and/or Medical Necessity” section of this LCD.

Dosage and Administration

Refer to the FDA label for Qutenza® (capsaicin) 8% patch for information on the administration of this drug.

Dosage forms and strengths

• Qutenza® patch contains 8% capsaicin (640 mcg/cm²). Each patch contains a total of 179 mg. of capsaicin. This patch can be cut to match the size and shape of the treated area.

Sources of Information and Basis for Decision

ClinicalTrials.gov. (2008). NGX-4010 for the treatment of postherpetic neuralgia. Food and Drug Administration. (NCT00115310, NCT00061776, NCT00068081, & NCT00300222).

Food and Drug Administration (FDA) prescribing information for Qutenza&® (capsaicin) 8% patch. (2009).

NeurogesX. (2010). Submission of evidenced-based clinical and economic data in support of formulary consideration: Qutenza®(capsaicin) 8% patch. Academy of Managed Care Pharmacy (AMCP) formulary submission.

Whitley, R., Volpi, A., McKendrick, M., van Wijck, A., & Oaklander, A. (2010). Management of herpes zoster and post-herpetic neuralgia now and in the future. Journal of clinical Virology 48 S1, S20-S28.

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 including

interventional pain management and internal medicine.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2011

Revision History Number 1

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

Start Date of Notice Period:01/01/2011 Revision Effective Date 01/01/2011

LCR A2011-019

December 2010 Bulletin

Explanation of Revision: Annual 2011 HCPCS Update. HCPCS code C9268 was deleted and replaced with HCPCS code J7335. The effective date of this revision is based on date of service.

Revision Number Original

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

LCR A2010-042

August 2010 Bulletin

8/1/2010 - The description for Bill Type Code 13 was changed 8/1/2010 - The description for Bill Type Code 85 was changed

8/1/2010 - The description for Revenue code 0636 was changed

11/21/2010 - The following CPT/HCPCS codes were deleted: C9268 was deleted from Group 1

Reason for Change