Paying for your Coloplast Procedure

When considering a medical procedure, cost matters, the information below may help you to better understand your expenses as you plan to take control of your health.  Answer a few questions below to help find the information you may be looking for.

How will you be paying for your procedure?

Click below to learn more about the different ways to pay for your procedure.

*This information is provided for educational and guidance purposes only and does not constitute reimbursement or legal advice.
Coloplast recommends that you always consult your individual health plan.

Additional things to know about paying for your procedure

Many health plans require licensed HCPs to verify coverage and benefits and they may seek advanced approval for outpatient surgeries. If the procedure is not covered under your benefits, you may be able to appeal the decision.

  • Your physician’s office will verify the type of insurance plan you have, the effective dates, any medical policy guidance for the procedure, if there are exclusions, and whether a prior authorization is allowed. They will also provide an estimate of your out-of-pocket costs They will also identify what your out-of-pocket expenses will be. To obtain this information, they will need your group policy number  and the name of the policy holder.
  • Some health plans require prior authorization (sometimes called prior approval or pre-certification). This is the determination of the medical necessity and appropriateness of a specific treatment as a requirement for payment by your insurance provider. While prior authorization does not guarantee that the procedure is covered, some insurance providers require it prior to the procedure. If all the necessary information is submitted for review, the health plan will issue a prior authorization number. The process for getting prior authorization can average from 5 to 30 days.
  • Coverage of penile implants varies by insurance plan, so contact your health plan provider and ask if they require prior authorization. If they do, your physician’s office may be able to assist you in the process.
  • Pre-determination is a voluntary, written request for review of a treatment or service, including ones that may not be considered medically necessary or unproven by the health plan. Unlike prior authorization, pre-determination is offered by many health plans as an optional review process. Most pre-determination requests take an average of 30-45 days.
  • Coverage of penile implants varies by insurance plan, so contact your health plan provider and ask if they will provide a voluntary pre-determination review. If they will, your licensed HCP’s office may be able to assist you in the process.
  • If your plan states that no prior authorization is required, your HCP’s office may want to proactively complete a pre-determination.
  • A health plan should make available to you their policy and process for responding to appeals. This is often included with the extra pages when you receive a denial. A review by an external reviewer may be deemed as the definitive end step in the plan’s process. With the help of your physician, you may be able to appeal the denial.
    Payers often have several levels of appeals which may result in a peer-to-peer review. This is when your doctor meets (usually via a phone call) with a medical provider who works for your plan to discuss need and medical necessity.

What to do if you are denied coverage

Know your rights

You have the right to appeal health insurance plan decisions. If your health plan denies or refuses to pay for care, you have the right to appeal the decision through the health plan’s internal review process.

If you are denied coverage, health plans are required by law to tell you why. You also have the right to file an internal appeal, and your insurer can give you instructions on how to submit the appeal request, the deadline by which to submit the appeal request, and the availability of a Consumer Assistance Program (in some states).

There are a few reasons why your health plan may deny your proposed treatment, including:

  • Services are not considered medically necessary or appropriate in a specific healthcare setting or level of care
  • The health plan considers the treatment to be investigational, experimental, or unproven
  • The service requested is not a covered benefit under the plan
  • The claim was not filed in a timely manner

Preparing an appeal

If your claim is rejected, you can file an internal appeal. This is when you ask for a full and fair review of the decision. The Coloplast team can assist you and your HCP in this process at 1-855-230-7611.

In general, most health plans follow the process similar to the list below:

  • Level 1: Request for Reconsideration: Appeal is reviewed by the plan’s appeals department. The medical director may be involved and/or your physician can request to speak with the medical director as part of a “peer-to-peer” discussion.
  • Level 2: Elevate the Appeal: Second-level appeals are reviewed by medical directors and appeal department staff that were not involved in the original discussion for denial.
  • Level 3: Independent External review: Usually completed by an independent 3rd party (outside of the health plan) who enlists the assistance of a physician who is board certified in the same specialty as the requesting physician. External appeals mean the health plan no longer has a final say in whether or not to cover the service.

*If your state has a Consumer Assistance Program, they can also help file on your behalf.

If you have additional questions, call Coloplast Corporation at 1-855-230-7611 and/or visit company website at www.coloplast.us

Titan® and Titan® Touch Inflatable Penile Prosthesis – Important Safety Information

A penile implant, also called a penile prosthesis, is concealed entirely within the body to address erectile dysfunction (impotence). The implant requires some degree of manipulation before and after intercourse to make the penis erect or flaccid.​

Indications
The Titan and Titan Touch Inflatable Penile Prosthesis is indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.​

Contraindications
The Titan and Titan Touch Inflatable Penile Prosthesis is contraindicated in patients who have one or more of the following: (1) Patients with an active infection present anywhere in the body, especially urinary tract or genital infection. (2) Patients with a documented sensitivity to silicone. (3) Patients with unresolved problems affecting urination, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder. (4) Patients unwilling to undergo any further surgery for device revision.​

Warnings
Implantation of the device may make latent natural erections, as well as other interventional treatment options, impossible. Men with diabetes or spinal cord injuries, as well as immunocompromised patients, may have an increased risk of infection associated with a prosthesis. Implantation of a penile prosthesis may result in penile shortening, curvature or scarring.​

Precautions
Removal of an implanted prosthesis without timely reimplantation of a new prosthesis may complicate subsequent reimplantation or may make it impossible. MRI quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the Titan, and Titan Touch IPP. Be sure to consult with your physician. Patients should discuss all available treatment options and their risks and benefits with their physician. Health conditions which hamper sexual activity, such as severe chest pain (angina), may prevent successful use of this device. The prosthesis should not be implanted in patients who lack the manual dexterity or strength necessary to operate the device. Trauma to the pelvic or abdominal areas, such as impact injuries associated with sports (e.g., bicycle riding), can result in damage of the implanted device and/or surrounding tissues. This damage may result in the malfunction of the device and may necessitate surgical correction, including replacement of the device. The device may be used in the presence of Peyronie’s Disease.​

Potential Complications
Penile implants are surgical solutions requiring a healing period that have risks associated with surgery such as scrotal swelling, auto-inflation, discomfort, angulation/curvature, swelling (edema), device malfunction, chronic pain, difficulty with ejaculation, transient urinary retention, fever, migration, patient dissatisfaction, infection at surgical site or wound, deflation, swelling of clotted blood or clear fluid (hematoma/seroma), wound leakage, bleeding, delayed wound healing, narrowing of the opening of the foreskin (phimosis), sensory loss, cylinder malfunction, formation of thick tissue (fibrous capsule formation), over/under inflation, erosion, scrotal reddening (erythema), genital change, and inguinal hernia.​

This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a penile implant is right for you.​

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

Genesis® Malleable Penile Prosthesis – Important Safety Information

A penile implant, also called a penile prosthesis, is concealed entirely within the body to address erectile dysfunction (impotence). The device is manually positioned to simulate an erect or flaccid penis.

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 prosthesis is designed for the management of erectile dysfunction (impotence) stemming from a variety of causes, including: epispadias (a rare birth defect located at the opening of the urethra), pelvic fracture; spinal cord injury or disease; prostatectomy; cystectomy; abdominal-perineal resection (surgical removal of the anus, rectum, and sigmoid colon); multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism (prolonged and painful erection of the penis); and Peyronie’s disease (curvature of the penis). The Prosthesis may also be used in selected patients with psychogenic impotence.

Contraindications
The Genesis Malleable Penile Prosthesis should not be used in: patients with an active infection present anywhere in the body, especially urinary tract or genital infection; patients with a documented sensitivity to silicone; and, patients with unresolved urinary problems, such as an elevated residual urine volume secondary to bladder outlet obstruction or neurogenic bladder.

Warnings
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. Men with diabetes as well as immunocompromised patients, may have an increased risk of infection which could result in permanent damage to tissue/organs.

Consult with your physician if you are experiencing a change in rigidity or appearance of the erect penis. Replacement of the prosthesis may be necessary. If you have borderline bladder decompensation, an indwelling catheter, or enlargement of the prostate talk to your doctor.

Precautions
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. Talk with your physician regarding realistic expectations. Health conditions which hamper sexual activity (e.g. severe angina) may prevent successful use of this device. Penile implants are not considered lifetime implants due to the inherent nature of mechanical devices. Trauma to the pelvic area, such as impact injuries associated with sports, can result in damage of the implanted device and/or surrounding tissues. This damage may result in the malfunction of the device and may necessitate surgical correction, including replacement of the device.

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 new (de novo), persistent, worsening, lasting for a short time (transient), or permanent.

Penile implants are surgical solutions requiring a healing period that have risks associated with surgery such as deformity, delayed / impaired / abnormal wound healing, injury to tissue or organs (erosion / extrusion / migration) resulting in damage or loss of tissue (necrosis), opening or tunnel between tissue or organs (fistula), allergic reaction or sensitivity to device, collection of blood or fluid outside of tissue or vessels (hematoma, seroma), bleeding or excessive bleeding (hemorrhage), infection, redness or swelling of tissue, irritation, penile implant moves (migration), penile tissue dying off (necrosis), pain/discomfort, inability to pull the foreskin forward over the tip of an uncircumcised penis (paraphimosis), inability to pull the foreskin back from the tip of an uncircumcised penis (acquired phimosis), perforation or injury of soft tissue (e.g., muscles, nerves, vessels), penile structures, or organs (e.g., urethra), scarring, difficulty during sexual activity, numbness or decreased sensation in penis, blockage or slowing of urine (urethral obstruction / occlusion), urinary tract infection, and difficulty emptying bladder.

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

This treatment is prescribed by your physician. Discuss the treatment options with your physician to understand the risks and benefits of the various options to determine if a penile implant is right for you.

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