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Is Spaceoar Covered By Medicare

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Who Should Consider Spaceoar Who Shouldnt

San Diego Living – Boston Scientific SpaceOAR

DR. FITZGERALD: Most patients who will be having radiation for prostate cancershould consider having SpaceOAR Hydrogel to minimize any rectal damage from the radiation while allowing more effective treatment of the prostate cancer by the radiation. Any patient considering radiation for their prostate cancer therapy should discuss SpaceOAR with his radiation oncologist and urologist.

Spaceoar Frequently Asked Questions

Q: What is SpaceOAR Hydrogel?

A: SpaceOAR Hydrogel is an absorbable gel material that creates a temporary space between the prostate and the rectum, potentially reducing radiation dose to the rectum during prostate cancer radiation. It separates the prostate and rectum and is naturally absorbed by the body in about six months.3 More than 50,000 patients worldwide have been successfully treated with SpaceOAR Hydrogel.7

Q: For what condition is SpaceOAR Hydrogel used?

A: SpaceOAR Hydrogel is an option for men preparing to undergo radiation treatment for prostate cancer. It is designed to reduce the radiation dose delivered to the rectum and help maintain rectal function.

Q: How common is prostate cancer?

A: Prostate cancer is the most common cancer in American men. In the United States, more than 183,000 new cases of prostate cancer are diagnosed each year. More than 60,000 American men opt for radiation treatment every year to treat their prostate cancer.2

Q: How is prostate cancer treated?

A: Prostate cancer is highly treatable and there are a number of treatment options available based on things like the stage of the disease, a person’s age, how healthy they are and their personal preferences. Three common options include watchful waiting to see if the tumor grows or spreads, surgery to remove all or part of the prostate, or radiation to kill cancer cells and shrink the tumors.

Q: What are the common side effects of prostate cancer treatment?

What Are The Common Side Effects Of Prostate Cancer Treatment

The side effects of prostate cancer treatment vary based on the treatment method chosen. Surgery and radiation have been shown to be the two most successful treatments for low and intermediate grade prostate cancer. The most common complications following surgery are related to the urinary system, such as incontinence and erectile dysfunction while complications following radiation are often related to rectal radiation injury .

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Have More Questions We Can Help

Sign up to receive more information about SpaceOAR Hydrogel. Our patient education team can provide you with details about how SpaceOAR Hydrogel works, what to ask your doctor and how to find a doctor in your area.

Are you a physician looking for more information? Please click here.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

SpaceOAR Hydrogel is intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR Hydrogel to reduce the radiation dose delivered to the anterior rectum.

As with any medical treatment, there are some risks involved with the use of SpaceOAR Hydrogel. Potential complications associated with SpaceOAR Hydrogel include, but are not limited to: pain associated with SpaceOAR Hydrogel injection pain or discomfort associated with SpaceOAR Hydrogel needle penetration of the bladder, prostate, rectal wall, rectum or urethra injection of SpaceOAR Hydrogel into the bladder, prostate, rectal wall, rectum or urethra local inflammatory reactions infection injection of air, fluid or SpaceOAR Hydrogel intravascularly urinary retention rectal mucosal damage, ulcers, necrosis bleeding and rectal urgency. Please talk to your doctor about the risks and benefits associated with SpaceOAR Hydrogel.

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What Are The Costs Associated With Radiation Therapy

SpaceOar

Radiation therapy treatment at public or partnership radiation therapy centres is generally provided without a cost to the patient.

Radiation therapy at a private centre may incur out of pocket costs, also known as a gap or gap payment. This is the difference between the cost of treatment and Medicare rebate. You are required to pay the full cost yourself before you can claim a rebate from Medicare.

Any direct costs charged by a radiation therapy centre, Medicare rebates applicable to you and any out of pocket costs that you will need to pay must be made clear to you before treatment begins.

You will also need to confirm with the radiation therapy centre what other costs you are likely to need to pay as part of your overall treatment and recovery. Allied health care providers may be free of charge in the public system or may incur a cost if they are private providers. Your doctor or the radiation therapy centre may be able to advise you about your eligibility for government assistance for travel and accommodation.

You have the right to choose the radiation therapy centre who will provide your treatment based on your needs and considering all the costs involved. Many radiation therapy centres have accounts staff to talk you through these considerations.

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What Is Spaceoar Hydrogel

DR. FITZGERALD: Many men choose radiation therapy to treat their prostate cancer. The rectum is considered to be the “Organ at Risk” during radiation because there is very little space between the back side of the prostate and the front side of the rectum.

SpaceOAR is a man-made gel substance that is placed to create a temporary space between the prostate and rectum. SpaceOAR Hydrogel helps to protect the rectum, which is right next to the prostate, from the potentially harmful effects of the radiation. SpaceOAR Hydrogel is absorbed by the body in 3-6 months.

Figure 1: before SpaceOAR Hydrogel

Figure 2: after SpaceOAR Hydrogel has been applied

Figure 3: side-by-side view

Radiation Treatment For Prostate Cancer: What Is Spaceoar Hydrogel

Today, Dr. James M. Fitzgerald joins us on the blog for a Q& A about SpaceOAR Hydrogel. As with all content on Greater Boston Urology’s blog, the following information is educational in nature, not medical advice. Always talk to your physician about your specific health care questions and conditions.

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I Think I’m Interested In Learning More About Spaceoar What Should I Do Next

DR. FITZGERALD: Any man who plans to have radiation therapy for his prostate cancer should ask his urologist and/or radiation oncologist about SpaceOAR. As mentioned, GBU patients have SpaceOAR Hydrogel placed in our North Easton, Plymouth, and Falmouth Care Centers.

We have been referred patients from other urologists and radiation oncologists who do not place SpaceOAR themselves but realize the benefits to their patients. We welcome patients from outside of GBU to have us place their SpaceOAR Hydrogel. We place the SpaceOAR and then the patient returns to his urologist and radiation oncologist to continue his treatment and ongoing care.

Thanks, Dr. Fitzgerald!

Spaceoar And Prostate Cancer

The Biggest Problem with Radiation Treatment for Prostate Cancer and How To Beat It!

Prostate cancer is the most common cancer in American men, with more than 183,000 new cases diagnosed each year.1 More than 60,000 American men opt to treat their prostate cancer with radiation every year, while some may choose to have their prostate surgically removed or “watch and wait.”2 Because of the proximity of the rectum to the prostate, prostate radiation therapy can cause unintended damage to the rectum, which can lead to fecal incontinence issues or other long- lasting side effects. These side effects can be a barrier for men who might otherwise seek radiation, but there are options available to help reduce some of these risks.

SpaceOAR Hydrogel is an absorbable gel that creates a temporary space between the prostate and the rectum, designed to reduce radiation dose to the rectum. It is inserted via a minimally invasive procedure and is naturally absorbed by the body in about six months.3 SpaceOAR Hydrogel has been evaluated in clinical studies and has been shown to be safe and effective in reducing potential side effects of radiation therapy to the rectal area. In a randomized clinical study, men who underwent radiation therapy without SpaceOAR Hydrogel were eight times more likely to experience a decline in bowel, urinary and sexual function when compared to men who underwent radiation therapy with SpaceOAR Hydrogel, at a median follow-up of three years.4,5

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What If I Have A Concession Card

Holding a Concession Card does not automatically mean that out of pocket costs will be lower. Please let the radiation therapy centre know that you have this as it helps them to understand your individual circumstances.

Holding a Concession Card reduces the level at which the Medicare Safety Net Threshold applies and provides extra support to reduce your out of pocket costs.

Radiation Therapy And Private Health Insurance

Radiation therapy is usually an outpatient treatment and as such is not covered by private health insurance, regardless of the level of coverage.

Some private health insurance products will cover radiation therapy if you are being treated as an inpatient. You should speak to your health insurance provider to clarify coverage.

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What Is The Medicare Safety Net

The Medicare Safety Net is a Federal Government health program that provides a higher Medicare benefit for eligible services, including radiation therapy, when a health consumer reaches a threshold of out of pocket costs . This threshold depends on personal circumstances, for example, if the health consumer holds a concession card.

You need to meet certain criteria to be eligible for the Medicare Safety Net.

The Medicare Safety Net thresholds and any reimbursements are reviewed annually on 1 January and calculated for the calendar year. Single individuals are automatically registered but families need to formally register with the program.

The Medicare Safety Net provides an extra benefit to health consumers with high out of pocket medical treatment costs. It reduces the amount of out of pocket costs for radiation therapy.

The Medicare Safety Net does not reduce the direct cost of radiation therapy treatment. It results in a higher Medicare rebate, reducing the out of pocket cost to you.

The standard Medicare rebate and the additional Medicare Safety Net rebate are automatically calculated and paid into your bank account once a fully paid claim is lodged with Medicare.

For more information about the Medicare Safety Net visit

How Do I Check What Has Been Paid By Medicare Or My Private Insurer

SpaceOar

You can review previous Medicare contributions towards your radiation therapy by looking at your account online at

This applies to treatment at both public and private radiation therapy centres.

If applicable, you can review the contribution of your private health insurance by asking your health insurance provider for a statement.

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Cms National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services , National Coverage Determinations and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process . In addition, an administrative law judge may not review an NCD. See Section 1869 of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act :

Section 1862 excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1862 refers to limitations on items or devices that are investigational or experimental.

Section 1833 prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

How Well It Works

For men with localized prostate cancer, radiation works about as well as surgery to treat the cancer. With either treatment, the chance of the cancer spreading is low. One study looked at men who had localized prostate cancer and found that the risk of dying was very low . The study found that the risk of dying was about the same, no matter which treatment the men chose.footnote 1

For men with advanced prostate cancer that has grown beyond the prostate but not into lymph nodes or bones, external-beam radiation combined with hormone therapy can work better than surgery. This treatment will often control cancer growth and give men many disease-free years.footnote 2

Radiation therapy also works well to treat pain when prostate cancer has spread to the bone.footnote 3

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How Is Spaceoar Placed Are Patients Awake During The Procedure Does It Happen In The Office Or Surgical Center/hospital

DR. FITZGERALD: Patients are typically awake during the procedure, which is usually well tolerated in the office with local anesthesia. The vast majority of our patients are able to have it done safely and with mild discomfort in the office at our North Easton, Plymouth, and Falmouth Care Centers.

Alternatively, if a patient prefers, we can place the SpaceOAR Hydrogel while the patient is in the hospital under general anesthesia. Dr. Stephen Craig Gillard from our Plymouth Care Center places SpaceOAR in the operating room at BID Plymouth Hospital.

Why Is Spaceoar Hydrogel Important For Patients

When treating prostate cancer patients with radiation therapy, the goal is to kill the cancer cells while avoiding damage to surrounding healthy tissue. The prostate is next to the rectum and naturally separated by a small space. Due to the proximity, prostate radiation therapy can unintentionally cause damage to the rectum, which can lead to issues with bowel function. SpaceOAR Hydrogel is a gel spacer that temporarily moves the rectal wall farther away from the prostate. By separating the prostate from the rectum, the radiation dose delivered to the rectum is reduced, which may lessen damage to the rectum.Clinical data demonstrated the benefits of SpaceOAR Hydrogel, including a reduction of rectal injury resulting in maintained bowel function and a higher likelihood to maintain urinary and sexual function.

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Spaceoar Hydrogel Reduces Side Effects Of Prostate Cancer Radiation Therapy

While radiation treatment for prostate cancer has become much more precise over the years, the organs location immediately next to the rectal wall can expose the rectum to high dose radiation, which can lead to disruption in bowel function for some patients.

A new method for reducing these short- and long-term side effects is SpaceOar hydrogel, now available at Fox Chase.

In a minimally invasive outpatient procedure, the two liquid components of SpaceOAR hydrogel are injected through the peritoneum into the space between the rectal wall and the prostate by a urologist. The procedure is done under anesthesia with ultrasound guidance.

The resulting interaction between the two fluids creates a temporary and absorbable gel spacer that is primarily made of water. Hydrogels have been used in other implants such as surgical sealants used in the eye, brain and spine.

The OAR in SpaceOAR stands for Organ At Risk, referring to the rectum.

The position of the prostate poses particular challenges for the higher doses of radiation treatment required for this type of cancer, Fox Chase radiation oncologist Mark Hallman MD, PhD said. The posterior prostate lies right on top of the interior rectal wall and this puts the rectum at increased risk.

SpaceOAR was approved as a medical device by the FDA in 2015 and Fox Chase is among the first in the Philadelphia area to offer it.

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Questions To Ask Your Radiation Therapy Provider About Costs

  • What are your fees? Can I have an estimate of these in writing?
  • Are there additional fees for other doctors or healthcare professionals? Are these fees included in your estimate?
  • Will I have any out of pocket costs/gap payments?
  • If the cost changes, when will you let me know?
  • When do I need to pay?
  • Do I need to pay the whole amount upfront? Or can I pay in instalments?
  • What if I need a prosthesis/implant?
  • Should I contact my health insurance provider?
  • Can I access any assistance in relation to accommodation and travel?
  • Page last updated: 15/01/20

    Risks Associated With Implantation Of Spaceoar Hydrogel

    SpaceOar

    In addition to the risks associated with any medical procedure, potential complications include but are not limited to the following: pain or discomfort associated with SpaceOAR hydrogel needle penetration of the bladder, prostate, rectal wall, rectum or urethra injection of SpaceOAR hydrogel into bladder, prostate, rectal wall, rectum or urethra local inflammatory reactions infection injection of air, fluid or SpaceOAR hydrogel intravascularly urinary retention rectal mucosal damage, ulcers, necrosis bleeding, constipation and rectal urgency.

    The information presented in the Updates in Urologic Oncology eNewsletter is provided for physicians and other healthcare providers only and should not be shared with any current or future patients. If you are not a healthcare provider, we welcome you to sign up for Thrive eNewsletter to receive the latest information and blog highlights from Fox Chase Cancer Center.

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