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Treatment for adults with Dupuytren's
contracture with a palpable cord

As part of the XTRA Program, assistance is available to help trained HCPs and eligible adult patients acquire XIAFLEX®.

Is my patient covered for XIAFLEX®?

Assistance is available to help trained HCPs and eligible patients acquire XIAFLEX®

Insurance coverage

  • XIAFLEX® is covered by Medicare and for ~93% of claims for patients with commercial insurance*
    • Patient benefit design may vary, please be sure to verify your patients' coverage via the XIAFLEX® Reimbursement Helpline at 877-XIAFLEX (877-942-3559)

Based on insurance verification of >16,000 patient claims during the period of 1/1/15 – 12/31/15.

Download forms to assist with claims, access, and reimbursement

SIX steps to help streamline the XIAFLEX® reimbursement process

  1. Identify potential candidates

    • Identify eligible patients
      • XIAFLEX® (collagenase clostridium histolyticum) is indicated for adults with Dupuytren's contracture with a palpable cord
      • Some patients may be ineligible for surgery or would prefer an in-office procedure
    • Speak with your appropriate patients about XIAFLEX® as a treatment option
  2. Verify insurance benefits

    Always check patient benefits prior to obtaining XIAFLEX®

    • The XIAFLEX® Reimbursement Helpline can help you determine a patient’s coverage, out-of-pocket costs, prior authorization (PA) requirements, if applicable, and drug acquisition options
      • Financial assistance may be available for those patients who qualify
  3. Obtain XIAFLEX®

    • There are 2 options for obtaining XIAFLEX® (subject to payor requirements)
      • Buy-and-Bill: purchase XIAFLEX® from a Specialty Distributor and receive reimbursement from the payor after XIAFLEX® is administered
      • Specialty Pharmacy assignment of benefits: obtain XIAFLEX® through a Specialty Pharmacy that will bill the payor for XIAFLEX®
    • For details on the process of acquiring XIAFLEX® and for more information on our product acquisition partners, see below
  4. Schedule patient

    For vials obtained through the Specialty Pharmacy, it is recommended that you acquire XIAFLEX® prior to scheduling the patient

    • Schedule patient injection visit
      • The Specialty Pharmacy or distributor will work with your practice to coordinate a delivery date with the patient’s scheduled visit
  5. Treat patient

    • Perform the XIAFLEX® procedure
    • Schedule a follow-up visit (approximately 24 to 72 hours after the injection) where a finger extension procedure will be performed if a contracture persists
  6. File claim

    • Submit the claim; the following resources are available to help:
      • Your Reimbursement Specialist
        • Can review your claims for completeness and provide suggested codes
      • The XIAFLEX® Reimbursement Helpline at 877-XIAFLEX (877-942-3539)
        • Can help monitor claims to confirm payor processing and payment
        • Can provide templates for appeals in case a XIAFLEX® claim is denied

Patient Benefit coverage information

Insurance benefit verification checklist

Coverage

  • Is XIAFLEX® (collagenase clostridium histolyticum) covered under this patient’s health insurance plan?
  • Is XIAFLEX® covered under the patient’s medical or pharmacy benefit?
  • Is XIAFLEX® covered in the desired setting of care?
  • Does the insurer mandate any special distribution requirements for coverage (eg, Specialty Pharmacy)?
  • What are the patient’s out-of-pocket costs for XIAFLEX®?
  • Could the patient benefit from:
    • The XIAFLEX® Copay Program (for commercially insured patients)?
    • The Patient Assistance Program (for uninsured patients)?
  • Does the patient have an annual copay, deductible, or lifetime maximum? If yes, has this been met?

For assistance in determining coverage availability and prior authorization requirements for a particular patient, complete the Prescription and Benefits Investigation Form and fax it to the XIAFLEX® Reimbursement team at 1-877-909-2337.

Our XIAFLEX® Copay Program isn’t the only way we’re trying to help to make treatment more affordable for your eligible patients. To find out about other options for financial support, call 1-866-585-5591.

Some payors may require a prior authorization (PA). If the XIAFLEX® Reimbursement Helpline determines that your patient’s insurer requires a PA, the information will be included in the additional information section of the Prescription and Benefits Investigation Form.

Prior authorization requirements (if applicable)

  • What information or form is needed by the payor?
  • How is it submitted? How long does it take?
  • Will the payor provide a PA number to be included on the claim form?
  • If a Specialty Pharmacy provides XIAFLEX®, who obtains the PA—the physician’s office or the Specialty Pharmacy?
  • How long or how many injections/vials will the PA cover?

MOST THIRD-PARTY
PAYORS REQUIRE:

  • Letter of medical necessity
  • Payor-specific PA form
  • Patient medical records with appropriate chart notes
  • History of past therapies and results

For live support from our trained specialists, call the XIAFLEX® Reimbursement Helpline at 877-XIAFLEX (877-942-3539), Monday through Friday, 9:00 AM to 8:00 PM ET. For general, non-patient–specific questions about coverage and PA, please contact your Reimbursement Specialist.

Instructions for completing the Prescription and Benefits Investigation Form

Picture of the prescription and benefits investigation form
  1. PATIENT AUTHORIZATION

    Patients should carefully read this section before signing the completed form

  2. PATIENT INFORMATION

    The XIAFLEX® Reimbursement Helpline will use this information to research medical and pharmacy coverage for XIAFLEX® and related procedures, triage prescriptions to a Specialty Pharmacy, as appropriate, and verify the need for PA

  3. SHIP-TO INFORMATION

    Shipments of XIAFLEX® for this patient will be delivered to this practice location

  4. Rx INFORMATION

    When completed, this section serves as a prescription

  5. ACCESS PREFERENCE

    Please choose your preferred method for receiving XIAFLEX®

XIAFLEX® Acquisition

Obtaining XIAFLEX® from a Specialty Distributor or a Specialty Pharmacy

Specialty Distributor (BUY-AND-BILL)

Description
  • Provider’s practice purchases XIAFLEX® prior to the procedure
  • Provider submits a claim to the patient's insurer for the drug and the physician services
Payor
  • Medicare Part B
  • Many commercial payors
  • Some state Medicaid programs
Features
  • Just-in-time shipping eliminates the need to hold inventory
  • The distributor may offer up to 90 days to pay for the order

Specialty Pharmacy (ASSIGNMENT OF BENEFITS)

Description
  • Provider’s practice orders XIAFLEX® from a Specialty Pharmacy
  • Specialty Pharmacy ships XIAFLEX® to provider’s office and bills the insurance plan directly for the drug
  • Provider bills the patient’s insurer for the physician services
Payor
  • Many commercial payors
  • Most state Medicaid programs
Features
  • No upfront purchase of XIAFLEX®
  • The Specialty Pharmacy will check patient benefits, help manage the PA process (with your support), and manage claim filing for the drug
  • Provider does not bill for the drug (but bills for the physician services)

Insurers may require you to use a specific acquisition method. For information on a particular insurer, call the XIAFLEX® Reimbursement Helpline at 877-XIAFLEX (877-942-3539), Monday through Friday, from 9:00 AM to 8:00 PM ET, or contact your Reimbursement Specialist.

Specialty Distributor (BUY-AND-BILL) ACQUISITION METHOD

HCP bills for drug and professional services

  1. HCP selects an Endo-contracted Specialty Distributor

    Note: If ordering for a specific patient, specify 1 or 2 vials.

  2. XIAFLEX® Reimbursement Helpline verifies patient’s insurance benefits

  3. Upon approval, HCP contacts Specialty Distributor and purchases XIAFLEX®

  4. Specialty Distributor ships drug to HCP

  5. HCP administers drug, bills payor (for drug and procedure), and pays Specialty Distributor

Always check patient benefits prior to obtaining XIAFLEX®
Product Acquisition

When a practice obtains XIAFLEX® from a Specialty Distributor, the practice pays for the drug and then bills the insurance plan for both the drug and the procedure.

Please discuss purchase terms with your Specialty Distributor.

Besse Medical

Specialty Pharmacy Provider (SPP) ACQUISITION METHOD

HCP bills only for professional services

  1. HCP submits Prescription and Benefits Investigation Form to the Helpline for benefit verification. Then the HCP may send the form directly to the appropriate SPP

    Note: Please make sure to clearly indicate 1 or 2 vials on form.

    Icon of a pointer finger with a bow pointing upAllow time

    Typical processing time is 2 weeks; some cases may take up to 4 weeks

  2. SPP verifies patient's insurance benefits and identifies any PA requirements and patient financial responsibilities

    Icon of a pointer finger with a bow pointing upBe prepared

    SPP may need to communicate directly with you to gather additional information about insurance and processing needs. Additionally, you may be required to submit a PA request

  3. SPP notifies patient of any financial obligations (copayment/co-insurance) and asks him or her to accept the Rx order

    Icon of a pointer finger with a bow pointing upAlert the patient

    Patients should expect a call from the SPP. They will be asked to accept the prescription and to make arrangements to pay their copay, if applicable

  4. SPP bills payor for drug and bills patient for any copayment or co-insurance

  5. SPP coordinates with HCP to schedule drug shipment

  6. SPP dispenses drug for individual patient with prescription label attached and ships drug to HCP site

  7. HCP administers drug and bills payor for physician services

Product acquisition

When a practice obtains XIAFLEX® from a Specialty Pharmacy, the pharmacy bills the insurance plan directly for the drug and the practice bills the insurance plan only for physician services.

US Bioservices

What to expect from the SPP

When your signed prescription is forwarded to the Specialty Pharmacy, either directly by your office or through the XIAFLEX® Reimbursement Helpline under your direction, the receiving Specialty Pharmacy will initiate its process to dispense XIAFLEX® (collagenase clostridium histolyticum). That process will include the following key steps:

  • Acknowledgement of Prescription Receipt
    The pharmacy will acknowledge initial receipt of your prescription within 24 hours via fax
  • Perform a Benefits Investigation
    The pharmacy will begin an internal benefits investigation of the patient’s benefits. The results of this benefits investigation will be communicated to you via fax within 24 hours of completion of this process
  • Provide Updates on the Prescription Status
    The pharmacy should provide periodic updates on the status of the prescription. It is always recommended that your office contact the specific pharmacy directly with any questions regarding the status of the prescription
  • Contact the Patient
    The pharmacy will directly contact the patient with the results of its benefits investigation, ask the patient to accept the prescription, and make arrangements to collect any copay or co-insurance
  • Schedule XIAFLEX® Shipment With Your Office
    The pharmacy will coordinate with your office to schedule the initial XIAFLEX® product shipment date and any subsequent refills
  • Inquire About a Refill
    The pharmacy will communicate with your office approximately 14 days after dispensing the initial prescription to inquire about the necessity of a refill. Please make sure to clearly indicate 1 or 2 vials*

*Injections and finger extension procedures may be administered up to 3 times per cord at approximately 4-week intervals.

If you are unsure about which XIAFLEX® access option may be best for your patients and your practice, ask your Specialty Sales Consultant or call the XIAFLEX® Helpline at 877-XIAFLEX (877-942-3539)
For your adult patients with Dupuytren’s contracture with a palpable cord, consider XIAFLEX®

Possible Codes

Possible codes for treating a single joint in 1 visit

XIAFLEX® Billing for Healthcare Provider Offices, Hospital Outpatient Departments, and Ambulatory Surgery Centers

Chart of data on the XIAFLEX(R) suggested coding for treating a single joint in 1 visit

*Application of finger splint should be used only when the procedure is performed in a physician’s office.
These amounts are provided as an example of the recommended dose and wastage in accordance with the XIAFLEX® Prescribing Information.
NOTE: Coding is part of the clinical decision. Please use codes that most accurately reflect the procedures performed.
Suggestions by Endo Pharmaceuticals Inc. do not guarantee reimbursement or take the place of professional coding advice.
SOURCES: ICD-10 Code Lookup. Centers for Medicare & Medicaid Services Website.
Accessed October 25, 2016. CPT® 2012 Standard Edition. Chicago, IL: American Medical Association; 2011.
Billing and Coding Guidelines. Centers for Medicare and Medicaid Services Website. Accessed November 14, 2016.
CPT® Code Detail - 29130. Optum360 EncoderPro. Accessed February 2, 2017.
JW Modifier: Drug amount discarded/not administered to any patient. Centers for Medicare and Medicaid Services Website. June 9, 2016. Accessed November 14, 2016.

Possible codes for treating 2 joints in the same hand in 1 visit

The codes used to describe single joint treatment of adult patients with Dupuytren’s contracture with a palpable cord may also be used to describe treatment of up to 2 joints in the same hand during a treatment visit

Chart of data on the XIAFLEX(R) suggested coding for treating 2 joints in the same hand in 1 visit

It is possible that any given payor may accept or require a different coding paradigm for same-day, dual cord treatments such as the use of modifier (51, 76, 59, or XS) and/or billing service individually on separate line items. Please contact the XIAFLEX® Reimbursement Helpline (877-942-3539) or the payor’s Provider Service Representative to acquire more information on coding guidance.

*Application of finger splint should be used only when the procedure is performed in a physician’s office.
These amounts represent 58 units per cord/joint (total of 116 units) and wastage of 32 units per cord/joint (total of 64 units) and are provided as an example of the recommended dose and wastage in accordance with the XIAFLEX® Prescribing Information.
NOTE: Coding is part of the clinical decision. Please use codes that most accurately reflect the procedures performed.
Suggestions by Endo Pharmaceuticals Inc. do not guarantee reimbursement or take the place of professional coding advice.
SOURCES: CPT® 2012 Standard Edition. Chicago, IL: American Medical Association; 2011. CPT is a registered trademark of the American Medical Association.
Billing and Coding Guidelines. Centers for Medicare and Medicaid Services Website. Accessed November 14, 2016.
CPT® Code Detail - 29130. Optum360 EncoderPro. Accessed February 2, 2017.
JW Modifier: Drug amount discarded/not administered to any patient. Centers for Medicare and Medicaid Services Website. June 9, 2016. Accessed November 14, 2016.

 

Contact your Reimbursement Specialist to receive reimbursement coding support for XIAFLEX®.

CLAIMS APPEALS

In case your claim is denied or under-reimbursed:
  • Review your Explanation of Benefits to understand why the request or claim has been denied
  • Contact your Endo Pharmaceuticals Reimbursement Specialist to help you gather the information and materials needed for an appeal
  • Complete and submit the appeal within the time frame allowed in the appeals process
Tools are available for denied patient claims:
XIAFLEX® Denied Finger Extension Procedure Appeal Letter
XIAFLEX® Denied Injection Claim Appeal Letter

SEE THE LATEST TOOLS AVAILABLE TO HELP YOU AND YOUR PATIENTS IN THE APPEALS PROCESS.
VISIT OUR REIMBURSEMENT SUPPORT SERVICES.

Dedicated Support

For HCPs

Specialty Sales Consultant (SSC)

  • Your SSC is your primary resource for Information and process Support related to acquiring XIAFLEX®

To address case-specific coding, billing, and reimbursement questions, your SSC can refer you to a designated Field Reimbursement Manager (FRM)

Your FRM is ready to help you with:

  • Coverage and logistical questions
  • Product access options
  • Coding questions

For Patients

Patient support

  • With the XIAFLEX® Copay Program, eligible patients can receive up to $1200 for their out-of-pocket costs for each vial of XIAFLEX®

Endo Pharmaceuticals Inc. is committed to helping appropriate patients access XIAFLEX®

  • Live support for office and patient provided by trained specialists through the XIAFLEX® Reimbursement Helpline at 877-XIAFLEX (877-942-3539), Monday–Friday, 9 AM–8 PM, ET

The XIAFLEX® Reimbursement Helpline is also available to provide answers to your reimbursement questions.

XIAFLEX(R) reimbursement helpline phone number 877-XIAFLEX and flowchart
See More

Important Safety Information for XIAFLEX®

  • XIAFLEX® is contraindicated in patients with a history of hypersensitivity to XIAFLEX® or to collagenase used in any other therapeutic application or application method
  • In the controlled and uncontrolled portions of clinical trials in Dupuytren's contracture, flexor tendon ruptures occurred after XIAFLEX® injection. Injection of XIAFLEX® into collagen-containing structures such as tendons or ligaments of the hand may result in damage to those structures and possible permanent injury such as tendon rupture or ligament damage. Therefore, XIAFLEX® should be injected only into the collagen cord with a MP or PIP joint contracture, and care should be taken to avoid injecting into tendons, nerves, blood vessels, or other collagen-containing structures of the hand. When injecting a cord affecting a PIP joint of the fifth finger, the needle insertion should not be more than 2 to 3 mm in depth and avoid injecting more than 4 mm distal to the palmar digital crease
  • Other XIAFLEX®-associated serious local adverse reactions in the controlled and uncontrolled portions of the studies included pulley rupture, ligament injury, complex regional pain syndrome (CRPS), sensory abnormality of the hand, and skin laceration (tear). In a historically controlled post-marketing trial, the incidence of skin laceration (22%) was higher for subjects treated with two concurrent injections of XIAFLEX® compared with subjects treated with up to three single injections in the placebo-controlled premarketing trials (9%). Cases of skin laceration requiring skin graft after finger extension procedures have been reported post-marketing. Signs or symptoms that may reflect serious injury to the injected finger/hand should be promptly evaluated because surgical intervention may be required
  • In the controlled portions of the clinical trials in Dupuytren's contracture, a greater proportion of XIAFLEX®-treated patients (15%) compared to placebo-treated patients (1%) had mild allergic reactions (pruritus) after up to 3 injections. The incidence of XIAFLEX®-associated pruritus increased after more XIAFLEX® injections in patients with Dupuytren's contracture
  • Because XIAFLEX® contains foreign proteins, severe allergic reactions to XIAFLEX® can occur. Anaphylaxis was reported in a post-marketing clinical study in one patient who had previous exposure to XIAFLEX® for the treatment of Dupuytren's contracture. Healthcare providers should be prepared to address severe allergic reactions following XIAFLEX® injections
  • In the XIAFLEX® trials in Dupuytren's contracture, 70% and 38% of XIAFLEX®-treated patients developed an ecchymosis/contusion or an injection site hemorrhage, respectively. Patients with abnormal coagulation (except for patients taking low-dose aspirin, eg, up to 150 mg per day) were excluded from participating in these studies. Therefore, the efficacy and safety of XIAFLEX® in patients receiving anticoagulant medications (other than low-dose aspirin, eg, up to 150 mg per day) within 7 days prior to XIAFLEX® administration is not known. In addition, it is recommended to avoid use of XIAFLEX® in patients with coagulation disorders, including patients receiving concomitant anticoagulants (except for low-dose aspirin)
  • In the XIAFLEX® clinical trials for Dupuytren's contracture, the most common adverse reactions reported in ≥25% of patients treated with XIAFLEX® and at an incidence greater than placebo were edema peripheral (eg, swelling of the injected hand), contusion, injection site hemorrhage, injection site reaction, and pain in the injected extremity

INDICATION

XIAFLEX® is indicated for the treatment of adult patients with Dupuytren's contracture with a palpable cord.

Please see the full Prescribing Information, including Medication Guide.