LCD/NCD Portal

L31225

 

QUTENZA® (CAPSAICIN) 8% PATCH

 

01/01/2011

 

Indications and Limitations of Coverage and/or Medical Necessity

 

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-week, 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:

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

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

o 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.

o Inhalation of airborne 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.

 

 

13x Hospital Outpatient

85x 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

053.19 HERPES ZOSTER WITH OTHER NERVOUS SYSTEM COMPLICATIONS

 

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

053.19 HERPES ZOSTER WITH OTHER NERVOUS SYSTEM COMPLICATIONS

 

 

Documentation 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.

 

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.

o Qutenza® will be sent directly to sites of care, such as physicians’ offices and hospital outpatient clinics, where it can be appropriately applied.

o Given its administration requirements, it is expected that Qutenza® would be administered by pain specialists in their offices.

o 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

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

• Dosage forms and strengths .

o Qutenza® patch contains 8% capsaicin (640 mcg/cm²). Each patch contains a total of 179 mg. of capsaicin.

 

Treatment Logic

• Shingles or herpes zoster rash is a painful viral infection caused by a reactivation of the varicella-zoster virus (human herpes virus, type 3) that causes chickenpox.

• Post herpetic 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.

 

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).

 

FCSO LCD 31245, Qutenza® (capsaicin) 8% patch, 01/01/2011. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

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.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

CMS LCD L31225 Qutenza® (capsaicin) 8% patch