MyQutenzaCoverage Reimbursement Guide...Postherpetic Neuralgia (PHN) ICD-10-CM Description B02.23...

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MyQutenzaCoverage is available to assist HCPs throughout the reimbursement process.

Visit: MyQutenzaCoverage.com Call: 855-802-8746Fax: 855-454-8746

MyQutenzaCoverage Reimbursement Guide

Not Actual Patients



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20MyQutenzaCoverage is available to assist HCPs throughout the reimbursement process.

Visit MyQutenzaCoverage.com Call 855-802-8746Fax: 855-454-8746

Table of Contents

Introduction .................................................................................................................................. 1

Important Safety Information ....................................................................................................... 2-3

Product Overview ......................................................................................................................... 4

Reimbursement Solution ............................................................................................................. 5

Coding Information (HCPCS, Modifiers) ..................................................................................... 6

Coding Information (ICD-10-CM Codes, NDCs) ......................................................................... 7

Coding Information (CPTs) ........................................................................................................... 8

Considerations for Verifying Insurance Benefits ........................................................................ 9

Sample Claim Forms (CMS-1500) ............................................................................................... 10

Sample Claim Forms (CMS-1450) ............................................................................................... 11

Claims Filing Checklist ................................................................................................................. 12

Common Denial Reasons ............................................................................................................ 13

Strategies for Appealing Denied Claims ..................................................................................... 14

Sample Template Letter of Medical Necessity ........................................................................... 15

Sample Template Letter of Appeal .............................................................................................. 16

Sample Procedure Notes Template ............................................................................................. 17



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Introduction

Averitas Pharma has developed this resource to support healthcare professionals (HCPs) navigate coverage, coding, and reimbursement for QUTENZA (capsaicin) 8% topical system.

Understanding coverage, coding, and reimbursement is critical for ensuring patient access and successful claims adjudication.

The information in this QUTENZA Reimbursement Guide is intended solely as a resource to assist the staff in physicians’ offices and hospitals with certain reimbursement-related questions. Averitas Pharma makes no representation about the information provided, as reimbursement information, including applicable policies and laws, are subject to change without notice from Averitas Pharma. This Reimbursement Guide is not conclusive or exhaustive and is not intended to replace the guidance of a qualified, professional advisor. The appropriate staff member of a physician’s office or hospital, not Averitas Pharma, determines the appropriate method of seeking reimbursement based on the medical procedure performed and any other relevant information. Averitas Pharma does not recommend or endorse the use of any particular diagnosis or procedure code(s), and makes no determination regarding if or how reimbursement may be available. The use of this information does not guarantee payment or that any payment received will equal a certain amount.

Information about the Healthcare Common Procedure Coding System (HCPCS) codes is based on guidance issued by the Centers for Medicare & Medicaid Services (CMS) applicable to Medicare Part B and may not apply to other public or private payers. Consult the relevant manual and/or other guidelines for a description of each code to determine the appropriateness of a particular code and for information on additional codes. Please refer to payer policies for specific guidance.



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Important Safety Information

INDICATION

QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

IMPORTANT SAFETY INFORMATION

Do not dispense QUTENZA to patients for self-administration or handling. Only physicians or healthcare professionals under the close supervision of a physician are to administer and handle QUTENZA.

Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract, and skin in healthcare providers and others. When administering QUTENZA, it is important to follow these procedures:

• Administer QUTENZA in a well-ventilated treatment area.• Wear only nitrile gloves when handling QUTENZA or any item that makes contact with QUTENZA, and when

cleaning capsaicin residue from the skin. Do not use latex gloves as they do not provide adequate protection. • Use of a face mask and protective glasses is advisable for healthcare providers.• Keep QUTENZA in the sealed pouch until immediately before use.• Use QUTENZA only on dry, intact (unbroken) skin.• In patients treated for neuropathic pain associated with diabetic peripheral neuropathy, a careful examination

of the feet should be undertaken prior to each application of QUTENZA to detect skin lesions related to underlying neuropathy or vascular insufficiency.

• During administration, avoid unnecessary contact with any items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets.

• Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward.

• Immediately after use, clean all areas that had contact with QUTENZA and properly dispose of QUTENZA, associated packaging, Cleansing Gel, gloves, and other treatment materials in accordance with local biomedical waste procedures.

• If QUTENZA is cut, ensure unused pieces are properly disposed of.

ContraindicationsNone

Please see additional Important Safety Information on next page.Please see full Prescribing Information.



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Important Safety Information (cont)

Warnings and Precautions• Unintended exposure to capsaicin can cause severe irritation of eyes, mucous membranes, respiratory tract,

and skin.• Do not apply QUTENZA to the face, eyes, mouth, nose, or scalp to avoid risk of exposure to eyes or mucous

membranes. Accidental exposure to the eyes and mucous membranes can occur from touching QUTENZA or items exposed to capsaicin and then touching the eyes and mucous membranes. Wear nitrile gloves when administering QUTENZA and avoid unnecessary contact with items in the room, including items that the patient may later have contact with, such as horizontal surfaces and bedsheets. If irritation of eyes or mucous membranes occurs, remove the affected individual from the vicinity of QUTENZA and flush eyes and mucous membranes with cool water.

• Aerosolization of capsaicin can occur upon rapid removal of QUTENZA. Therefore, remove QUTENZA gently and slowly by rolling the adhesive side inward. Inhalation of airborne capsaicin can result in coughing or sneezing. If irritation of airways occurs, remove the affected individual from the vicinity of QUTENZA. Provide supportive medical care if shortness of breath develops.

• If skin not intended to be treated is exposed to QUTENZA, apply Cleansing Gel for one minute and wipe off with dry gauze. After the Cleansing Gel has been wiped off, wash the area with soap and water.

• Patients may experience substantial procedural pain and burning upon application and following removal of QUTENZA. Prepare to treat acute pain during and following the application procedure with local cooling (such as a cold pack) and/or appropriate analgesic medication.

• Transient increases in blood pressure may occur during and shortly after the QUTENZA treatment. Blood pressure changes were associated with treatment-related increases in pain. Monitor blood pressure and provide adequate support for treatment-related pain. Patients with unstable or poorly controlled hypertension, or a recent history of cardiovascular or cerebrovascular events, may be at an increased risk of adverse cardiovascular effects. Consider these factors prior to initiating QUTENZA treatment.

• Reductions in sensory function have been reported following administration of QUTENZA. Decreases in sensory function are generally minor and temporary. All patients with pre-existing sensory deficits should be clinically assessed for signs of sensory deterioration or loss prior to each application of QUTENZA. If sensory deterioration or loss is detected or pre-existing sensory deficit worsens, continued use of QUTENZA treatment should be reconsidered.

Adverse ReactionsIn all controlled clinical trials, adverse reactions occurring in ≥5% of patients in the QUTENZA group and at an incidence at least 1% greater than in the control group were application site erythema, application site pain, and application site pruritus.

Adverse Event ReportingPhysicians, other healthcare providers, and patients are encouraged to voluntarily report adverse events involving drugs or medical devices. To make a report you can: • In the U.S., visit www.fda.gov/medwatch or call 1-800-FDA-1088; or• For QUTENZA, you may also call 1-877-900-6479 and select option 1, or press zero on your keypad to talk to

an operator to direct your call.

Please see full Prescribing Information.



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Product Overview

QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet.

A single, in-office procedure, may provide up to 3 months of relief from neuropathic pain associated with PHN or from neuropathic pain associated with DPN of the feet. QUTENZA is the first and only prescription-strength capsaicin product targeted to the TRPV1-expressing nociceptive nerve fibers in the skin.

QUTENZA NDC #72512-928-01(10-digit format)

NDC #72512-929-01(10-digit format)

Packaging: Kit (carton) contains one (1) single-use topical system and one (1) 50 g tube of Cleansing Gel

Kit (carton) contains two (2) single-use topical systems and one (1) 50 g tube of Cleansing Gel

Strength:Contains 8% capsaicin (640 mcg per cm2). Each QUTENZA topical system contains a total of 179 mg of capsaicin.

OrderingInformation:

QUTENZA is available through select specialty distributors.

Specialty Distributors: ASD Healthcare® 800-746-6273Besse® Medical 800-543-2111Cardinal Heath™ 877-453-3972CuraScript SD® 877-599-7748

Specialty Pharmacy Partners:LifeSaveRx 877-254-8603Rivers Edge 949-393-5780, Option 2

StorageGuidelines: Store between 20° and 25°C (68° and 77°F). Excursions between 15° and 30°C (59° and 86°F) are

allowed. Keep the topical system in the sealed pouch until immediately before use.

ReimbursementQuestions andSupport:

Health insurance coverage for QUTENZA may vary from plan to plan. For more information aboutreimbursement support, call MyQutenzaCoverage at 855-802-8746 or email Field Access Support at [email protected].



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MyQutenzaCoverage Reimbursement Solution

MyQutenzaCoverage is designed to help navigate the reimbursement landscape and help your patients gain access to QUTENZA (capsaicin) 8% topical system. Contact the MyQutenzaCoverage team of experts for help with the following:

• MedicalandpharmacybenefitinvestigationsforQUTENZA• Completionofbenefitinvestigation• Identificationofinsurancecoverage,out-of-pocketcosts,andmethodof

product procurement

• Determination of prior authorization requirements and forms• Provisionofpayer-specificpriorauthorizationforms• Trackingandfollow-up

• Assist with appeals and denials • HCP support for Letter of Medical Necessity Template• HCP support for Letter of Appeal Template

• WorkwithHCPandspecialtypharmacytoassistwithprescription

• Dedicatedsupportforpatient-specificreimbursementissues

MyQutenzaCoverage.com

Fax a completed Benefits Request Form to 1-855-454-8746

Call 1-855-802-8746 (M-F) 9 AM–7 PM ET



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Coding Information

The information presented on this page is of a general nature and for informational purposes only. Coding and coverage policies change periodically and often without warning. The responsibility to determine coverage andreimbursementparameters,andappropriatecodingforapatientand/orprocedure,isalwaystheultimateresponsibility of the provider. The manufacturer does not recommend use of QUTENZA (capsaicin) 8% topical system in a manner inconsistent with its label. Physicians must consult the QUTENZA full Prescribing Information, including the limitations applicable to approved use of QUTENZA.

Healthcare Common Procedure Coding System (HCPCS) CodesClaims for physician-administered drugs or devices billed under the medical benefit must be submitted with an HCPCS code to identify the drug or device administered to the patient. QUTENZA has been issued permanent HCPCS codes and these should be used accordingly when submitting a claim to payers.

HCPCS Code Description

J7336 Capsaicin 8% topical system, per square centimeter

J7336JW Drug amount discarded/not administered to any patient

ModifiersEffective January 1, 2017, the use of the JW modifier is required for Medicare Part B claims with unused drugs or biologicals from single-use vials or single-use packages that are appropriately discarded. Providers are required to document the amount of the discarded drug or biological in the patient’s medical record.

The discarded drug should be billed on a separate line with the JW modifier. Please remember to verify the milligrams given to the patient and then convert to the proper units for billing based on the code descriptor. Please refer to CMS.gov for further information.

Thismodifierisprovidedforeducationalpurposesonlyanddoesnotguaranteepayment.Itisthehealthcareprovider’sresponsibilitytousethemodifiersinamannerconsistentwithCPTandapplicablepayerinstructions. Useofthismodifierisnotaguaranteeofreimbursement.

Modifier Description

J7336JW Drug amount discarded/not administered to any patient

Medicare administrative contractors require that providers submit claims that reflect both the actual amount ofQUTENZA administered to a patient as well as the amount that was discarded (if any). When indicating the amountof QUTENZA discarded, the JW modifier should be used on a separate line on the claim form.



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Coding Information (cont)

National Drug Codes (NDCs)The United States Food and Drug Administration (FDA) lists NDCs in a 10-digit format, but payers often require an 11-digit NDC in a 5-4-2 format for electronic claims forms. Guidelines for reporting the NDC in the appropriate format, quantity, and unit of measure, as well as the location on the claim form, may vary by payer. HCPs should review payer-specific requirements prior to submitting a claim.

NDC Description

NDC #72512-0928-01 1 Kit (carton includes 1 topical system and cleansing gel)

NDC #72512-0929-01 2 Kit (carton includes 2 topical systems and cleansing gel)

BillingUnitsOne QUTENZA topical system is equivalent to 280 cm2 billing units. The provider should submit claims accurately reflecting the amount of QUTENZA used to treat a patient.

Diagnosis CodesApplicable International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) codes are listed below. A complete list of available codes can be found at CMS.gov.

Postherpetic Neuralgia (PHN)

ICD-10-CM Description

B02.23 Postherpetic polyneuropathy

B02.29 Other postherpetic nervous system involvement

Diabetic Polyneuropathy (DPN)

ICD-10-CM Description

E08.40 Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecified

E08.42 Diabetes mellitus due to underlying condition with diabetic polyneuropathy

E10.40 Type 1 diabetes mellitus with diabetic neuropathy, unspecified

E10.42 Type 1 diabetes mellitus with diabetic polyneuropathy

E11.40 Type 2 diabetes mellitus with diabetic neuropathy, unspecified

E11.42 Type 2 diabetes mellitus with diabetic polyneuropathy

E13.40 Other specified diabetes mellitus with diabetic neuropathy, unspecified

E13.41 Other specified diabetes mellitus with diabetic mononeuropathy

E13.42 Other specified diabetes mellitus with diabetic polyneuropathy



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Coding Information (cont)Current Procedural Terminology (CPT) CodeNo existing CPT code is specific to the QUTENZA administration procedure. If the QUTENZA application procedure is performed during an Evaluation and Management (E&M) service, it may be appropriate to report an E&M code if payer-specific reporting requirements have been met. If providing a separate E&M service at the same time as the administration procedure, it may be appropriate to report the E&M code with a modifier. A complete list of available codes and instructions governing their use can be found in the CPT codebook. Please note that payers may have additional requirements. These codes are provided for educational purposes only and do not guarantee payment. It is the healthcare provider’s responsibility to use the diagnosis code(s) that accurately and fully reflect the patient’s condition.

CPT Code Description

CPT 64620 Destruction by neurolytic agent, intercostal nerve

CPT 64632 Destruction by neurolytic agent; plantar common digital nerve

CPT 64999 Unlisted procedure, nervous system

CPT 64640 Destruction by Neurolytic Agent Procedures on the Somatic Nerves

E&M Code Description

CPT 96999 Unlisted special dermatological service or procedure

CPT 99201 Office or other outpatient visit for the evaluation and management of a new patient, which requires these three key components: a problem-focused history; a problem-focused examination; and straightforward medical decision-making

CPT 99202 Office or other outpatient visit for the evaluation and management of a new patient, which requires these three key components: an expanded problem-focused history; an expanded problem-focused examination; and straightforward medical decision-making

CPT 99203 Office or other outpatient visit for the evaluation and management of a new patient, which requires these three key components: a detailed history; a detailed examination; and medical decision-making of low complexity

CPT 99204 Under New Patient Office or Other Outpatient Services. A medical procedural code under the range - New Patient Office or Other Outpatient Services

CPT 99205 Office or other outpatient visit for the evaluation and management of a new patient, which requires these three key components: a comprehensive history; a comprehensive examination; and medical decision-making of high complexity

CPT 99211 Office or other outpatient visit for the evaluation and management of an established patient that may not require the presence of a physician. Usually, the presenting problem(s) are minimal

CPT 99212 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a problem-focused history; a problem-focused examination; and straightforward medical decision-making

CPT 99213 Office or other outpatient visit with an established patient, which requires at least two of these three key components: expanded problem-focused history; expanded problem-focused exam; and low medical decision-making

CPT 99214 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least two of these three key components: a detailed history, a detailed examination, and decision-making of moderate complexity

CPT 99215 Office or other outpatient visit for the evaluation and management of an established patient, which requires at least 2 of these 3 key components: comprehensive history; comprehensive examination; and decision-making of high complexity



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ConsiderationsforVerifyingInsuranceBenefits

It is important to understand and verify patient insurance benefits prior to initiating treatment. Conducting a benefit verification can provide the HCP office with the following:

Payer coverage requirements Coding and billing requirements Patient cost-share amount

Recommended Best Practices:

Obtain the patient’s general information, insurance information, your facility/office’s Tax ID and NPI, then call the payer’s provider services line.

Verify that HCPCS and CPT codes for use are covered for the patient’s diagnosis. Provide applicable ICD-10-CM code(s).

Ask if any documentation should be submitted with the claim. If so, ask what and how the documentation should be submitted.

Ask about the coverage criteria specifically for the use of QUTENZA.

Ask if the payer has set a maximum number of applications or treatment options and,

if so, how many.

Ask if the payer has a specific medical policy pertaining to QUTENZA (capsaicin) 8% topical

system and, if so, can they provide a link to the policy.

Ask if a referral is required from the primary care physician.

Inquire if the patient has any coverage limitations or policy exclusions for the treatment and application of QUTENZA.

Ask if there are any prior authorization/ pre-determination requirements and how

to meet these requirements.

Verify your contracted reimbursement rate for HCPCS and CPT codes and how much the

patient will be required to pay out-of-pocket.



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APPROVED OMB-0938-1197 FORM 1500 (02-12) PLEASE PRINT OR TYPE

MM DD YY MM DD YY 11 J7336

MM DD YY MM DD YY 11 J7336JW

B02.23

QUTENZA (capsaicin 8% patch, 1 cm2) NDC 7251292801

MM DD YY

280

JW 100*

MM DD YY MM DD YY 11 64999 1

Box 19 Indicate drug name, NDC, strength, and route of administration (physician administered)

Box 21 Enter the appropriate ICD-10 diagnosis code (this should be reflected in the patient’s medical record)

Box 24D Enter the appropriate HCPCS code for QUTENZA and CPT code(s) for administration services (add modifier if applicable)

Box 23 Document prior authorization referral number from payer (if applicable)

Box 24G Enter the number of billing units for the associated HCPCS and CPT codes

CPT CODE



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Sample Claim Forms

CMS-1500 Claim Form Sample For reimbursement of QUTENZA (capsaicin) 8% topical system administered by a physician’s office, providers must submit a CMS-1500 claim form for the drug and associated services.

As of 2020, the use of QUTENZA is covered by specific codes and may be considered medically necessary (depending on the payer) when certain criteria have been met, such as:• Diagnosis of postherpetic neuralgia (PHN) AND/OR neuropathic pain associated with diabetic peripheral

neuropathy (DPN) of the feet• A CPT code that indicates how the physician administered the drug in addition to coding specifics. Some payers

may require additional information, such as a drug purchase invoice or documentation of medical necessity

QUTENZA 8% topical system 72512-0928-01



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Sample Claim Forms (cont)

CMS-1450 Hospital Outpatient Department Claim Form SampleUB-04 is used for reimbursement administered in an outpatient institutional setting, such as an outpatient hospital, a clinic, or an ambulatory surgical center.

• Providers must submit a UB-04 claim form documenting the drug administered and associated services• Coding specifics for the UB-04 claim form (based on payer specifications) should be used

Box 42 Medicare/Medicaid and most private payer claims must include revenue codes

Box 80 Indicate the name of the drug, NDC, and route of administration

Box 66 Enter the appropriate ICD-10 diagnosis code (this should be reflected in the patient’s medical record)

Box 44 Enter the HCPCS code for the outpatient service (add modifier if applicable)

Box 46 Indicate the units of service used. Enter the number of units discarded (if applicable) on a separate line and include the JW modifier

Box 43 Description or NDC must be indicated

INSERT CPT CODE DESCRIPTIONS CPT CODE

ICD-10 CODE

Patch application healthcare provider administered under physician supervision.



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ClaimsFilingChecklist

A clean claim is defined as a claim free of errors. In order to facilitate prompt and accurate payment, it is important to ensure that the information on the claim is accurate and error-free. Consider the following:

Always verify the patient’s insurance eligibility and coverage before treatment. Working with MyQutenzaCoverage will also provide support

Check payer policies for covered diagnoses and treatment frequency limits. Double check claims for simple/clerical errors

Check for codes that are billed but not supported by documentation, have incorrect dates of services, or have missing provider or patient data

Verify the codes entered on the claim form; a simple transposition error can delayprocessing or cause the claim to be processed incorrectly

Ensure each service is linked to the appropriate diagnosis code and the frequency (eg, units) is within appropriate limits

Most electronic claims processing software and/or clearinghouses have the capability to perform simple proofreading functions

Check with your payers to ensure you have the most up-to-date fee schedule



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Common Denial Reasons

Understanding the reason for a denial will determine next steps for resolving the denial. Here are some commonreasons a claim may be denied and actions one may take to overturn the denial.

Error: Technical Required Action:

• Call to correct• Prepare and submit a corrected claim• Contact Field Access Support for assistance

Error: Billing Required Action:

• Prepare and submit a corrected claim• Prepare and submit an appeal• Contact Field Access Support for assistance

Error: Medical Necessity Required Action:

• Prepare and submit an appeal• Contact Field Access Support for assistance

Error: Payer Denial Required Action:

Insurance payer doesn’t pay for product • Step Edit, Not on Formulary • Investigative Product

• Prepare and submit an appeal• Contact Field Access Support for assistance

Incorrect patient ID, missing signatures:• Missing or incorrect code (eg, transposed numbers)• Incorrect units

Non-covered or non-allowed service:• Service was unbundled• Incorrect placement of service code• Duplicate claim• Invalid code• Incorrect units

The diagnosis code is not covered for the services performed:• Medical record documentation does not support the

services performed as medically necessary and in accordance with the respective medical policy in place

Working with MyQutenzaCoverage to obtain accurate benefits will help to prevent claim denials. Call MyQutenzaCoverage at 1-855-802-8746 or email Field Access Support at [email protected].



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Strategies for Appealing Denied Claims

In some cases, a denied claim can be resolved over the phone, but in other cases, an HCP may need to completeand submit an appeal letter in order to overturn a denied claim. Here are some strategies for working throughthis process:

Whatisthelimitfortimelyfilinganappeal?

TIP: File the claim appeal as soon as possibleandwithintimelyfilinglimits.

Whatisthemethodforsubmission(eg,electronic,fax,ormail)?

TIP: Verify that faxing or submission throughaportal/applicationisanoptiontosubmitanappeal,asthepayerhasdiscretion in what format they use.

Howlongdoestheappealprocessusuallytake?

TIP: Timelines for reprocessing the claim can be delayed due to incomplete requests.

HowwillthepayercommunicatetheappealdecisiontotheHCP?

TIP: Timelines for actual payment after a favorable decision can vary by payer. Checkwiththepayersoyouknowwhento follow up if you do not receive payment.

Isthereaparticularformthatmustbecompleted?

TIP: Payers will often post template forms for download on their website. If you cannotlocatetheformonline,contact the payer for additional guidance.

Limits for timely filing vary by level of appeal and by payer. For example, the first level of appeal (redetermination) for Medicare requires appeal submission within 120 days of receipt of denial.

HCPs may submit written requests via mail, fax,or secure internet portal/application depending on the payer.

Decision times vary by level of appeal and payer.

Payers generally will respond via the method used in the request, followed by a letter received by mail.

Check with the payer to confirm if they have a specific form or guidelines for submitting an appeal.



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Sample Template Letter of Medical NecessityThese sample letters are intended to provide an example of how to structure a letter of appeal and letter of medicalnecessity for QUTENZA (capsaicin) 8% topical system. The HCP should modify the format of these letters as appropriate. (e.g, to reflect the patient’s specific facts and circumstances, or to include specific information that may be required by individual payers).

M-QZA-US-11-20-0022 11/2020

LETTER OF MEDICAL NECESSITY [To be completed by prescriber and printed on letterhead]

[Date]

[Name of Health Insurance Company] [Attn:] [Address] [City, State, Zip] Re: Letter of Medical Necessity for QUTENZA (capsaicin) 8% Topical System Patient: [Patient Name] Group/policy Number: [Number] Date(s) of service: [Dates] Diagnosis: [Code & Description] Dear [Insert contact name or department]:

I am writing on behalf of my patient, [PATIENT NAME], to document medical necessity for treatment with QUTENZA (capsaicin) 8% Topical System. QUTENZA is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. This letter serves to document that [PATIENT NAME] has a diagnosis of [DIAGNOSIS] and needs treatment with QUTENZA, and that QUTENZA is medically necessary for [him/her] as prescribed. On behalf of the patient, I am requesting approval for use and subsequent payment for the treatment.

Patient Medical History and Diagnosis: [PATIENT NAME] is a [AGE]-year-old [MALE/FEMALE] diagnosed with [DIAGNOSIS]. [NAME OF PATIENT] has been in my care since [DATE]. As a result of [DIAGNOSIS], my patient [ENTER BRIEF DESCRIPTION OF PATIENT HISTORY]. Additionally, [PATIENT] has tried [PREVIOUS THERAPIES] and [OUTCOMES]. The attached medical records document [PATIENT NAME]’s clinical condition and medical necessity for treatment with QUTENZA.

Based on the above facts, I am confident that you will agree that QUTENZA is indicated and medically necessary for this patient. The plan of treatment is to start the patient on QUTENZA and monitor and follow up as appropriate.

Please consider coverage of QUTENZA on [PATIENT NAME]’s behalf and approve use and subsequent payment for QUTENZA as planned. Please refer to the enclosed Prescribing Information for QUTENZA. If you have any further questions regarding this matter, please do not hesitate to call me at [PHYSICIAN TELEPHONE NUMBER]. Thank you for your prompt attention to this matter.

Sincerely, [PHYSICIAN NAME] [PROVIDER IDENTIFICATION NUMBER]

Enclosures: (Attach as appropriate) Prescribing Information (PI) Clinic notes & labs



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Sample Template Letter of AppealThese sample letters are intended to provide an example of how to structure a letter of appeal and letter of medicalnecessity for QUTENZA (capsaicin) 8% topical system. The HCP should modify the format of these letters as appropriate. (e.g, to reflect the patient’s specific facts and circumstances, or to include specific information that may be required by individual payers).

LETTER OF APPEAL [To be completed by prescriber and printed on letterhead]

[Date]

[Name of Health Insurance Company] [Attn:] [Address] [City, State, ZIP]

Re: Letter of Appeal for QUTENZA (capsaicin) 8% topical system

Patient: [Patient Name] Group/Policy Number: [Number] Date(s) of service: [Dates] Diagnosis: [Code & Description]

Dear [Insert contact name or department]:

I am writing to request a review of a denied claim for [PATIENT NAME]. The claim was denied for the following reason(s), listed on the attached Explanation of Benefits (EOB).

[Fill in reason(s) from EOB.]

QUTENZA® (capsaicin) 8% topical system is indicated in adults for the treatment of neuropathic pain associated with postherpetic neuralgia (PHN) and for neuropathic pain associated with diabetic peripheral neuropathy (DPN) of the feet. This letter serves to document that [PATIENT NAME] has a diagnosis of [DIAGNOSIS] and needs treatment with QUTENZA, and that QUTENZA is necessary therapy for [him/her] as prescribed. On behalf of the patient, I am requesting approval for use and subsequent payment for the treatment.

Patient Medical History and Diagnosis: [PATIENT NAME] is a [AGE]-year-old [MALE/FEMALE] diagnosed with [DIAGNOSIS]. [NAME OF PATIENT] has been in my care since [DATE]. As a result of [DIAGNOSIS], my patient [ENTER BRIEF DESCRIPTION OF PATIENT HISTORY]. Additionally, [PATIENT] has tried [PREVIOUS THERAPIES] and [OUTCOMES]. The attached medical records document [PATIENT NAME]’s clinical condition and medical necessity for treatment with QUTENZA.

Based on the above facts, I am confident you will agree that QUTENZA is necessary therapy for this patient. The plan of treatment is to start the patient on QUTENZA and monitor and follow up as appropriate.

Please consider coverage of QUTENZA on [PATIENT NAME]’s behalf and approve use and subsequent payment for QUTENZA as planned. Please refer to the enclosed Prescribing Information for QUTENZA. If you have any further questions regarding this matter, please do not hesitate to call me at [PHYSICIAN TELEPHONE NUMBER]. Thank you for your prompt attention to this matter.

Sincerely, [PHYSICIAN NAME] [PROVIDER IDENTIFICATION NUMBER]

Enclosures: (Attach as appropriate) Prescribing Information (PI): https://www.qutenza.com/pdfs/Qutenza_Prescribing_Information.pdf Clinic notes & labs

M-QZA-US-10-20-0064 November 2020



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Sample Procedure Notes TemplateThese sample procedure notes are intended to provide justification for QUTENZA (capsaicin) 8% topical system coverage when dealing with payers. The HCP should complete these documents appropriately. Documents are available at MyQutenzaCoverage.com.

MyQutenzaCoverage Reimbursement Guide...Postherpetic Neuralgia (PHN) ICD-10-CM Description B02.23...

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