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Reimbursement &
Benefit Support

Helping you navigate the complexities of insurance

Empowering you to focus on
what you do best

Navigating the insurance landscape can be both daunting and time-consuming. Insurance issues can lead to patient frustrations, delayed reimbursements or even surgery cancellations.

Coloplast Interventional Urology offers comprehensive Reimbursement and Benefit Support. Upon request for you or your patients, our team of experts can assist you and your patients in managing the complexities of insurance and coverage for our products: Titan® and Titan Touch® inflatable penile implants; Genesis® malleable penile implant; Virtue® male sling; and Torosa® testicular implant.

Contact us

Our team is ready to help via
live phone support and email
Mon – Fri, 9am to 4pm CST.

US_MarketAccess@Coloplast.com

Fax: 612-520-2366

Support starts with 3 easy steps

Follow these few key steps to get your team set up for fast, efficient service from your Coloplast Reimbursement and Benefits Support team.

One time only Complete the Physician Enrollment Form (if you haven’t already). This form allows you to select and save your preferences. A PDF version of this form is available here.
For each patient

Both forms are required to complete requests
Complete the Support Request Form. This form will allow you to select which services you would like to complete for you and your patients (i.e., benefit verification, prior authorization, appeals, claims assistance). This form requires a physician signature (DocuSign is acceptable).

Have the patient complete the HIPAA Authorization Form. This form will need a signature from the patient (DocuSign is acceptable).

Forms can be emailed to US_MarketAccess@Coloplast.com or faxed to Coloplast US Benefit Support at 612-520-2366.
Please do not send PHI without a signed HIPAA Authorization Form.

Benefit verification

Our thorough verification process includes a detailed review of coverage and benefits, including all associated out-of-pocket expenses, so patients are well-informed prior to their surgery. Upon your request, our team confirms all details, including:

  • Type of plan and effective dates
  • Coverage limits, copayments, and deductibles
  • Relevant exclusions
  • Any medical policy guidelines for the procedure
  • Prior authorization requirements

We provide regular status updates, so your team is in touch with our progress until the full verification process is complete. And if requested by the provider, we can reach out to patients to explain their benefit coverage.

Insurance coverage map

Our interactive map lets you find coverage and policy details with just a few clicks.

  1. Choose a Coloplast product
  2. Select a state
  3. Choose an insurance provider
  4. Click on “View Payer Info” to see coverage information with a link to the policy details.

Explore map

Prior authorization

When an insurance provider requires prior authorization, our team streamlines the process for both your practice and your patients, upon your request. We’ll work with you to gather and submit relevant clinical information demonstrating the medical necessity of the treatment and will ensure the information submitted supports the medical necessity guidelines created by the insurance company’s coverage policies.

Claims assistance

Our team will walk you through compiling the proper paperwork, to ensure accurate billing and reimbursement.

If you have a denied claim, our team can call about what is needed to send a corrected claim or figure out the claim issue(s).

At every step, we will proactively communicate about our progress, so you always have insight into the process.

Get started with 3 easy steps.

Exclusions and appeals

If a patient’s prior authorization is denied or not covered, our team is here to guide you through the appeals or exceptions process. We will submit a formal appeal to the insurance company, including any relevant documentation or supporting evidence. We’ll also facilitate the steps of the process, from the initial request for reconsideration to elevating the appeal, through to the independent external review, if that becomes necessary.

Self-service resources

If you prefer to manage an appeal or exception on your own, these pre-written editable templates can help simplify the process and save you time and effort.

PENILE IMPLANT
Appeal Letter
TESTICULAR IMPLANT
Appeal Letter
PENILE IMPLANT
Exception Letter
TESTICULAR IMPLANT
Letter of Medical Necessity

Patient support resources

Discover patient-friendly resources to help you empower your patients to navigate some of the complexities of insurance appeals and exceptions.

Enroll for reimbursement and benefits support today

Ready to get the most out of our insurance and reimbursement services? Complete our one-time Physician Enrollment Form to select your preferences and get your team set up for fast, efficient service from your Coloplast Reimbursement and Benefit Support team.

Complete the Physician Enrollment Form

Disclaimer: Coloplast Corp. provides this information for your convenience only and makes no guarantees, expressed or implied, concerning the accuracy or appropriateness for any particular use of the information provided. It is intended for informational purposes for FDA approved uses only, and is not intended as a recommendation regarding clinical practice. A verification of benefits from Coloplast does not guarantee payment.

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PM-31531


Titan & Titan Touch Inflatable Penile Prosthesis Brief Statement

Indications
The Titan Inflatable Penile Prosthesis is indicated for male patients with erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis.

Contraindications
The Titan Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following conditions: Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. Patients with a documented hypersensitivity or allergic reaction to silicone or polyurethane. Patients with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder. Patients unwilling to undergo any further surgery for device revision.

Warnings
The Titan device should only be implanted by physicians experienced in the surgical procedures involving implantation of a penile prosthesis. Physicians should advise prospective patients, prior to surgery, of the warnings, precautions and potential complications associated with the use of this product, which may include the following: Potential for resurgery (Note: device is not a lifetime implant). Implantation makes latent natural erections, as well as other interventional treatment options, impossible. Implantation may result in penile shortening, curvature or scarring. Pre-existing abdominal or penile scarring or contracture may make surgical implantation more complicated or impractical. Diabetic, as well as immunocompromised patients, may have an increased risk of infection which could result in permanent damage to tissue/organs. Vigorous exercise and manual massage could lead to device damage. Certain stresses and pressures (straddle seating, obesity, etc.) could lead to involuntary inflation or deflation.

Precautions
Patients with spinal cord injury may have an increased risk of infection. This device may be used to treat ED in the presence of Peyronie’s disease. A thorough preoperative consultation should include a discussion between the patient and physician of available treatment options and their risks and benefits. Patient selection should consider the following factors which could lead to increased risk of failure and can be critical to the eventual success of the procedure: Ability and willingness of the patient to follow instructions. Associated psychological status (e.g. psychogenic erectile dysfunction, inappropriate attitude or motivation). Health conditions which hamper sexual activity, such as severe angina, may prevent successful use of this device. Manual dexterity problems.

Potential Complications
Adverse events are known to occur with penile protheses procedures and implants; some may require revision surgery or removal of the implant. Adverse events following penile protheses implantation may be de novo, persistent, worsening, transient, or permanent.

Adverse events may include but are not limited to: Acquired phimosis, Adhesion(s), Bladder storage symptoms, Capsular contracture, Deformity, Delayed/Impaired/Abnormal wound healing, Discomfort, Erosion/Extrusion, Fistula, Foreign body reaction, Hematoma/Seroma, Hemorrhage/Bleeding, Hernia, Hypersensitivity/Allergic reaction, Induration, Infection (local or systemic), Inflammation (including, but not limited to edema, erythema, redness, swelling), Male Dyspareunia, Necrosis, Obstruction/Occlusion, Pain, Perforation or injury of soft tissue (e.g., muscles, nerves, vessels), structures, or organs (e.g., bowel, bone, bladder, urethra, ureters), Scar tissue, Sexual dysfunction, Tactile disorders, e.g., hypoesthesia, numbness, Urinary incontinence symptoms, Urinary tract infection, Voiding symptoms.

The occurrence of these events may require one or more subsequent surgeries which may or may not always fully correct the complication.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

PM-02124 / Feb 2024


Genesis Malleable Penile Prosthesis Brief Statement

Intended Purpose
The Genesis Malleable Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence).

Indications
The Genesis Malleable Penile Prosthesis (Prosthesis) is designed for the management of erectile dysfunction (impotence) stemming from a variety of causes, including: epispadias, pelvic fracture, spinal cord injury or disease, prostatectomy, cystectomy, abdominal-perineal resection, multiple sclerosis, diabetes mellitus, alcoholism, arteriosclerosis and hypertensive vascular disease, priapism, and Peyronie’s disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

Contraindications
The Genesis Malleable Penile Prosthesis is contraindicated in patients who have one or more of the following conditions: patients with an active infection present anywhere in the body, especially urinary tract or genital infection, patients with a documented hypersensitivity or allergic reaction to silicone, patients with unresolved urinary problems such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder.

Warnings
It is the responsibility of the physician to advise the prospective patient prior to surgery, of the warnings and precautions associated with the use of this product and the associated surgical risks. The Genesis Malleable Penile Prosthesis should only be implanted by physicians experienced in the surgical procedures and techniques involving implantation of a malleable penile Prosthesis. The physician should maintain adequate education to conduct this procedure. Implantation of a penile Prosthesis may make natural erections difficult to achieve. It may make some other interventional treatment options not possible. Implantation of a penile Prosthesis may result in penile shortening, curvature or scarring. Pre-existing penile scarring or contracture may make surgical implantation more complicated or impractical. Failure to evaluate and promptly treat erosion may result in infection and loss of tissue. Men with diabetes as well as immunocompromised patients, may have an increased risk of infection which could result in permanent damage to tissue/organs. The Prosthesis should be used with caution in patients with borderline bladder decompensation, an indwelling catheter, or enlargement of the prostate.

Precautions
A thorough preoperative consultation should include a discussion between the patient and physician of other available treatment options and their risks and benefits. Patients should be informed that erections achieved with a malleable penile Prosthesis may differ from original erection (e.g. not of equal length or girth) compared to what was previously experienced with natural erections. Removal of an implanted Prosthesis without timely reimplantation of a new Prosthesis may make subsequent reimplantation more difficult.

Adverse Reactions
Adverse events are known to occur with penile protheses procedures and implants; some may require revision surgery or removal of the implant. Adverse events following penile protheses implantation may be de novo, persistent, worsening, transient, or permanent. Adverse Reactions include: deformity, delayed/Impaired/Abnormal wound healing, erosion/extrusion, fistula, foreign body reaction, hematoma/Seroma, hemorrhage/bleeding, hypersensitivity/allergic reaction, infection (local or systemic), inflammation (i.e., edema, erythema), irritation, migration, necrosis, pain/discomfort, paraphimosis/acquired phimosis, perforation or injury of soft tissue (e.g., muscles, nerves, vessels), penile structures, or organs (e.g., urethra), scar tissue, sexual dysfunction, tactile disorders (e.g., hypoesthesia, numbness), urethral obstruction/occlusion, urinary tract infection, and voiding symptoms.

The occurrence of these events may require one or more subsequent surgeries which may or may not always fully correct the complication.
The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.


Virtue® Male Sling System Brief Statement

Indications
The Coloplast Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

Contraindications
It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the contraindications associated with the use of this product. This product is contraindicated for patients with urinary tract infections or urinary tract obstruction; blood coagulation disorders or prescribed anticoagulation therapy; obstructive uropathy; or, are under the age of 18.

Warnings and Precautions
It is the responsibility of the surgeon to advise the prospective patients or their representatives, prior to surgery, of the possible warnings associated with the use of this product.

Potential Complications
As with all foreign bodies, the Virtue sling system is likely to exacerbate any existing infection. Transitory local irritation at the wound site and a foreign body response may occur. The resulting response could lead to wound dehiscence, extrusion, erosion, inflammation or fistula formation.

The following complications are known to occur with synthetic slings:
Urethral erosion
Infection
Bladder, urethra, vessel and nerve perforation
Known risks of incontinence surgical procedures include extrusion, erosion, infection, sling migration, pain, transient or permanent retention, bladder outlet obstruction, and, continued stress urinary incontinence and persistent or new overactive bladder symptoms.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to the product’s Instructions for Use. Alternatively, you may contact a Coloplast representative at 1-800-258-3476 and/or visit the company Website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN
12/21/2020
PM-02084


TOROSA® Saline-Filled Testicular Prosthesis

BRIEF STATEMENT
Physician Facing

Indications
The Coloplast TOROSA Saline-Filled Testicular Prosthesis is intended for use when cosmetic testicular replacement is indicated i.e., in the case of agenesis or following the surgical removal of a testicle.

Contraindications
The implantation of testicular prostheses is contraindicated in the presence of infection or untreated neoplasm.

Warnings
This device contains solid silicone elastomer. The risks and benefits of implanting this device in patients with lupus (e.g., SLE or DLE), scleroderma (e.g., progressive systemic sclerosis), myasthenia gravis, or documented sensitivity to silicone should be carefully considered. The issue of the possible relationship between silicone and various diseases has been and continues to be the subject of scientific and medical debate.

Sepsis or hemorrhage may result from the placement of any foreign object in the body.

Excessive fibrous capsular formation or contracture may occur around any implant placed in contact with soft tissues.

Precautions
Each prosthesis should be checked for patency prior to surgery and continuously monitored throughout the surgical procedure to ensure that the structural integrity of the implant is not compromised in any way.

The action of drugs (such as antimicrobials, chemotherapy agents or steroids) in contact with the prosthesis has not been tested by the manufacturer, and their use cannot be recommended. Each physician who chooses to use drugs in combination with this prosthesis must assure compatibility of the drug with silicone elastomer.

A thorough preoperative consultation should include a discussion between the patient and physician of all available treatment options and their risks and benefits.

Implantation of the TOROSA Saline-Filled Testicular Prosthesis may be difficult or impossible in patients with inadequate scrotal tissue to cover the prosthesis, patients who have undergone prior pelvic radiation therapy, or patients whose wound healing abilities are compromised (e.g., uncontrolled diabetes, poor circulation).

Potential Complications
Potential complications include pain and discomfort.

The information provided is not comprehensive with regard to product risks. For a comprehensive listing of indications, contraindications, warnings, precautions, and adverse events refer to this product’s Instructions for Use. Alternatively, you may contact a Coloplast Representative at 1-800-258-3476 and/or visit the company website at www.coloplast.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

Minneapolis, MN 12/04/2020