The Xiaflex benefits investigation form is a one-page document a provider’s office fills out and faxes to Keenova CARES at 1-877-909-2337 to confirm a patient’s insurance coverage, trigger prior authorization, and arrange delivery of the medication before the first injection is scheduled. Because a single vial can run upward of $7,500, nothing ships and no appointment should be booked until the hub returns its benefits summary.
What the Form Does
Xiaflex (collagenase clostridium histolyticum) is an injectable biologic approved for Dupuytren’s contracture and Peyronie’s disease.1Food and Drug Administration. Xiaflex Prescribing Information It has to be administered in a clinical setting, which means some insurers cover it under the medical benefit while others route it through the pharmacy benefit. The investigation form sorts that out, identifies the patient’s expected out-of-pocket cost and deductible status, flags whether prior authorization is required, and then kicks off shipping through either CVS Specialty Pharmacy or the specialty distributor Besse Medical. The clinic does not stock the drug; vials arrive just-in-time.
Finish REMS Enrollment Before You Submit
Xiaflex is distributed through the restricted XTRA Managed Distribution Program, and only trained, enrolled providers can obtain and inject it.2XIAFLEX for Dupuytren’s Contracture. Enrollment Resources The form has two mandatory REMS fields: a Healthcare Provider Enrollment ID and a Healthcare Setting Enrollment ID. These are separate from the NPI and DEA number, and the hub will return any form missing them. Providers who have not enrolled start at xdcenrollment.com by watching the training video and completing the online enrollment. If enrollment is recent, confirm the IDs are activated before faxing anything in.
Patient Information and Signatures
The top of the form collects the patient’s name, date of birth, home address, mobile phone, email, and the last four digits of the Social Security number, plus a secondary contact in case the hub cannot reach the patient. Verify the mobile number and email carefully. Those are the channels the hub and pharmacy use for copay amounts, shipment timing, and assistance eligibility.
Two patient signatures sit near the top of the form, and they do different things:
- Signature A authorizes the hub, insurer, and provider’s office to share the patient’s protected health information. Without it, the benefits investigation cannot run. HIPAA’s Security Rule governs how those parties handle the electronic exchange.3U.S. Department of Health & Human Services. Summary of the HIPAA Security Rule
- Signature B is optional and opts the patient into text updates from CVS Specialty Pharmacy about shipments and refills. It speeds up delivery coordination but is not required to submit the form.
Insurance Fields
Record the policy number, group number, and provider services phone number for both primary and secondary insurance. The provider services number has to be the one printed on the back of the card. The hub calls it directly to verify benefits, and a wrong number adds days.
If the patient has Medicare, you will also need the provider’s Medicare PTAN in the physician section. Medicare Part B pays physician-administered drugs at the average sales price plus six percent,4Centers for Medicare & Medicaid Services. Medicare Part B Drug Average Sales Price and the patient’s 20 percent coinsurance on a drug at this price point is substantial. The returned benefits report will state the exact expected liability.
Physician and Facility Section
This block identifies the treating provider and the office where the injection will be given. Fill in:
- Physician name and specialty.
- Practice name and ship-to address. Vials ship directly to the office, so this needs to be an address where someone can receive and refrigerate them.
- The 10-digit NPI assigned to the prescriber.5Centers for Medicare & Medicaid Services. National Provider Identifier Standard
- DEA number and Tax ID (TIN).
- Medicare PTAN, required only for Medicare patients.
- Both REMS enrollment IDs.
- A contact person, email, phone, and fax number. The benefits summary comes back by fax, so the fax number has to be correct and monitored.
A wrong NPI or a missing REMS ID is the fastest way to have the form bounced back.
Clinical Information
The clinical section is where the form documents medical necessity. The fields differ slightly by indication.
Peyronie’s Disease
The form’s default clinical layout targets Peyronie’s disease and asks for:
- ICD-10 code N48.6, induration penis plastica.6ICD10Data.com. ICD-10-CM Diagnosis Code N48.6 – Induration Penis Plastica
- Date of symptom onset.
- Current degree of penile curvature. The FDA-approved indication requires at least 30 degrees at the start of therapy, and insurer prior authorization criteria commonly mirror that threshold.1Food and Drug Administration. Xiaflex Prescribing Information
- Presence of a palpable plaque.
- Pain during intercourse or erection.
- Prior treatments. Not an FDA requirement, but some insurers want to see conservative measures first.
- Medication allergies.
- Anticipated injection date.
Dupuytren’s Contracture
For Dupuytren’s, use ICD-10 code M72.0, palmar fascial fibromatosis.7World Health Organization. International Statistical Classification of Diseases and Related Health Problems 10th Revision Document the palpable cord, which joints are affected (metacarpophalangeal or proximal interphalangeal), and the baseline contracture measurement in degrees. Insurers typically require at least 20 degrees of contracture associated with a palpable cord. Get that measurement into the chart before the form goes out.
Prescription and Dosing
The prescription section is pre-printed with the standard Peyronie’s regimen: 0.58 mg injected into the plaque twice, one to three days apart, at roughly six-week intervals for up to four cycles, with a penile modeling procedure one to three days after each second injection. The full course tops out at eight injections and four modeling procedures.1Food and Drug Administration. Xiaflex Prescribing Information The form specifies two vials per cycle (NDC 66887-003-01) and includes a checkbox to request the reconstitution and administration syringes (1-mL hubless syringes with 27-gauge, 0.5-inch needles).
For Dupuytren’s contracture the schedule is different: up to three injections per cord at roughly four-week intervals, with a finger extension procedure 24 to 72 hours after each injection. Two cords in the same hand, or one cord affecting two joints in the same finger, can be injected during a single visit. Adjust the dispense quantity and refills to match.
The prescriber’s signature on this section has to be handwritten. Stamps are not accepted, and a stamped signature will come back to you.
Submitting the Form
Fax the completed form to Keenova CARES at 1-877-909-2337. For questions while you fill it out, call 877-XIAFLEX (877-942-3539). There is no online portal; fax is the standard channel.
Before you fax, run through this list:
- Patient Signature A is present.
- Prescriber signature is handwritten, not stamped.
- Both REMS IDs are filled in.
- Insurance policy and group numbers match the card.
- NPI and TIN are accurate.
- Ship-to address is the correct clinic location.
- The provider office fax number is correct and someone is monitoring it.
An incomplete or unreadable form restarts the clock. A minute of verification saves roughly a week.
What Happens After You Fax It
A Keenova CARES representative verifies the patient’s insurance eligibility and checks whether prior authorization is required. If it is, the hub initiates the request on the provider’s behalf using the clinical information from the form. Straightforward benefits verifications take about two to three business days. Cases that need more clinical documentation or an insurer appeal take longer.
The hub faxes back a Summary of Benefits report covering:
- Whether Xiaflex falls under the medical or pharmacy benefit.
- The prior authorization status: approved, pending, or denied.
- The patient’s expected copay or coinsurance.
- The patient’s current deductible and out-of-pocket accumulator status.
If the insurer asks for more, chart notes, imaging, or a letter of medical necessity, the hub contacts the office with specifics. Respond quickly. Some insurers close prior authorization requests if supporting documents do not arrive within 10 to 14 days.
Once coverage is confirmed, the hub coordinates shipment. CVS Specialty Pharmacy contacts the office to schedule delivery around the anticipated injection date under the specialty pharmacy pathway, or Besse Medical ships just-in-time under the buy-and-bill pathway.
If the Insurer Denies Coverage
The benefits summary spells out the reason for any denial and the internal appeal instructions. The office can request a peer-to-peer review, where the prescriber speaks directly with the insurer’s medical director to argue medical necessity. Having objective measurements already in the chart (curvature in degrees, contracture in degrees, documented functional limitations) strengthens that conversation.
If the internal appeal is also denied, commercially insured patients on ACA-compliant plans have the right to an independent external review. The reviewer is a third party with no ties to the insurer and takes a fresh look at the claim.8eCFR. 45 CFR 147.136 – Internal Claims and Appeals and External Review The denial notice has to include instructions on how to start that review.
Financial Assistance the Hub Can Point To
Because of the price per vial, assistance is a practical concern for most patients.
Commercially insured patients may qualify for the XIAFLEX Copay Assistance Program, which reduces or eliminates out-of-pocket cost for the drug itself. The patient must be 18 or older, carry commercial insurance (not Medicare, Medicaid, VA, or any other government program), and have an out-of-pocket obligation.9XIAFLEX for Peyronie’s Disease. Cost and Support The program covers only the Xiaflex dose, not office visit copays, administration fees, or facility charges, and it can be used once every 30 days. Patients may need to report the value received to their insurer if the plan requires it.
Uninsured patients may qualify for the Endo Advantage Patient Assistance Program, which supplies Xiaflex at no cost and ships directly to the provider’s office. Medicare Part D beneficiaries are not eligible. The application line is 1-800-743-2382.
The HealthWell Foundation runs separate copay funds for Dupuytren’s disease and Peyronie’s disease.10HealthWell Foundation. Dupuytren’s Disease Grants help with prescription copayments, and, for Medicare Part B beneficiaries, insurance premiums. Eligibility runs up to 500 percent of the federal poverty level depending on household size and cost of living. Fund availability opens and closes as money comes in, so apply early.