Frequently Asked Questions
Frequently Asked Questions for HIFU In Radiation Failure
How is HIFU different after radiation failure?
Patients who have radiation failure get HIFU with a lower power. The Ablatherm machine that we use has the lowest incidence of rectal injury and has preset power for HIFU in post radiation failures.
Are there any other differences when you do HIFU after radiation failure?
The incidence of rectal injury and incontinence, although lower than if salvage surgery were performed, will still be higher than for newly diagnosed prostate cancer. For recent results from largest series done in France, please refer to Results of HIFU for radiation failure, click here.
What tests do I need before HIFU is done for radiation failure?
We will require documentation of local recurrence by a prostate biopsy. We need a multi-parametric MRI test to help determine if you have cancer on one or both sides of the prostate. This helps us treat only the area of the prostate that has recurrence, sparing the other tissue and reducing side effects.
Is a bone scan required?
We not only require bone scan, we require one of the newer PET scans AXUMIN that will detect if you have cancer recurrence in areas other than the prostate. Local treatment such as HIFU can be performed and does help even in patients who have limited metastases because treatment of the local tumor seems to block growth factors and other chemicals released by primary cancer that can influence growth of metastasis. For more information on AXUMIN and multi-parametric MRI, click here.
How does HIFU compare with other treatments that are given for radiation failure?
The most common treatment thats given for radiation failure is hormonal therapy. Hormonal therapy is associated with no cure; it just controls the cancer for a period of time and ultimately, patients develop metastasis.
What are the other problems with hormonal therapy?
Hormonal therapy for prostate cancer will kill the cancer cells temporarily and is useful for temporary measures while you're waiting on deciding on a prostate treatment or waiting for testing. After about 6-12 months of hormonal therapy, cancer cells become resistant and hormonal therapy no longer works.
What happens when hormonal therapy no longer works?
When hormonal therapy, no longer works, you are set to have castrate resistant prostate cancer. There are some newer treatments such as Enzalutamide, Abiratione, and similar agents that may prolong life expectancy. There are also some treatments such as Provenge that is an immune therapy. There are also newer chemotherapy agents such as Docetaxel. All of these might help for patients who have castrate resistant prostate cancer.
Medicare for HIFU
CMS recently announced the establishment of a new C-code for the ablation of prostate tissue using high intensity focused ultrasound (HIFU)
C-codes are unique temporary pricing codes established by CMS (Center for Medicare and Medicaid Services) that apply only to the hospital outpatient facility and the ambulatory surgery center (ASC) settings. The C-code does not apply to the office based outpatient surgery center or to physician services. Please note that there are NO codes for payment of the HIFU doctor’s fees or of the Anesthesia doctor’s fees.
HIFU has been assigned HCPCS C-Code C9747, Ablation of prostate, transrectal, high intensity focused ultrasound (HIFU), including imaging guidance C9747 became effective July 1, 2017.
Although, there is now a code and a payment has been determined, there is no coverage (reimbursement) as of July 5, 2017. How can this be?
CMS assigned a code (C9747) and a payment (APC 5376, Level 6 Urology and Related Services, national average payment of $7,452.66) to that code in a hospital. Surgery Centers receive approximately 55% of that amount.
However, having a code does NOT mean that Medicare will actually pay a facility for a HIFU procedure. Coverage is determined by the individual CMS Medicare Administrative Contractors (MACs). Please note that Medicare did NOT issue a national coverage determination (NCD) and that no Local MACs have issued a local coverage decision (LCD).
The U.S. is divided into twelve (12) regions for the purposes of administering Medicare claims, including coverage decisions. These MACs are private health care insurers that have been awarded a geographic jurisdiction to process Medicare Part A and Part B medical claims for Medicare Fee-For-Service (FFS) beneficiaries.
In the absence of a national Medicare policy, each MAC decides individually, according to their own criteria, whether to cover a procedure and, if so, under what circumstances. It is possible that different MACs will issue different local coverage determinations (LCD) or that CMS will issue a national coverage determination (NCD) in the future.
In our opinion, that the MACs will NOT issue local coverage decisions at this time. Typically, local coverage decisions are only issued after the publication of 3 scientific studies in peer reviewed medical journals. Although HIFU has been well studied in Europe and Asia and there are numerous published studies outside of the US that document it’s effectiveness, my opinion is that coverage determinations will be issued ONLY after the publication of results from US HIFU centers. A medical journal will usually require a few years of follow up in order to deem a study worthy of publication. Since the first HIFU procedures were done in the USA in December 2015, it is still too soon for studies to be submitted to medical journals and for them t be published. I think we are 2 – 3 years away from this at best.
Medicare patients should NOT expect Medicare to reimburse their HIFU procedure at this point in time. This may change as local MACs issue local coverage determinations in the future. Medicare patients will be required to sign an Advanced Beneficiary Notice (ABN). This document informs Medicare beneficiaries that reimbursement is not expected for HIFU treatment.
Frequently Asked Questions about HIFU for Prostate Cancer
Can this procedure be performed in the United States?
Yes. HIFU has been approved by the FDA in the United States. We currently have several centers in US performing HIFU. See our section under 'HIFU LOCATIONS' and 'OUR PHYSICIANS'. We are negotiating coverage nationwide, with many urologists, surgical centers and Academic Institutions. We are constantly updating our site as more physicians begin treating patients. Please contact us for more information.
How long until I can have the procedure?
If you or a loved one is interested in the HIFU procedure, please call one of our HIFU experts toll free at (844) HIFU-FLA. You may also fill out the contact form on the side of this page, and one of our experts will contact you shortly to discuss your options. Treatment can generally be arranged within a couple of weeks.
What happens if I have an enlarged prostate?
If you have an enlarged prostate (greater than 40 cc/grams), you may require pretreatment debulking by drug therapy or transurethral resection of the prostate (TURP). The size of the prostate is measured by ultrasound at the time of the biopsy.
I have a history with cardiac health problems. Do I still qualify?
Patients with a history of cardiac health problems can still qualify for HIFU, even though they may not qualify for surgery. Patients will be asked to provide blood work, an electrocardiogram, and a cardiologist consultation prior to treatment.
I am diabetic. Will that interfere with this procedure?
No, this will not interfere with this treatment option. Typically, someone who is insulin dependent is treated as the first case of the day.
Do you offer a payment plan?
Yes, we have a third party that arranges financing. We will put you in touch with them and they will make arrangements with you, independent of HIFU solution. Contacts for details.
Will my insurance cover the cost?
At the time, this procedure is self-pay. We will work with you to discuss your options with your insurance company, and they may or may not pay a portion of the cost. The procedure has been approved by the FDA in the United States, therefore it is available. Insurance coverage is expected in the next 12 to 24 months. Some insurance companies are covering it after the procedure on case by case basis. More companies are expected to provide coverage as demand for procedure keeps increasing.
Will I be able to deduct the cost of HIFU from my income taxes?
You will have to discuss this with your accountant.
How long will I be in the hospital?
With the HIFU treatment plan, no overnight stay is required. You will be able to go home within 2 hours after the procedure. However, since you will be administered anesthesia, you are required to travel with someone.
Who makes the machine?
There are two companies: Sonacare Medical located in North Carolina, a US company and EDAP, a French company.
Is this an inpatient or outpatient procedure?
This is an outpatient procedure, and it requires no overnight stay.
How long does the procedure take?
The treatment usually ranges from one to three hours depending on the size of your prostate and your specific situation.
What happens to the prostate after the procedure?
HIFU treatment completely destroys the prostate tissue and cancer cells, which reduces them to protein debris and non-viable tissue. Some of this tissue is re-absorbed by the body’s natural mechanisms and some of this tissue is removed through the urinary tract.
Do you have recent statistics regarding success rates and side effects?
The first HIFU treatment was performed in the 1990s. There have been several technological advancements since then, which took an already safe procedure and made it safer with less side effects. Results of HIFU is discussed elsewhere in this website.
Are there any medications that I should avoid prior to treatment?
Some of the common medications that need to be discontinued include: -Aspirin including baby aspirin -Xarelto -Eloquis -Plavix (Clopidogrel) -Coumadin (Warfarin) -Ticlid (Ticlopidine) -Herbal products and vitamins *some herbal products and vitamins have blood-thinning components, so it is necessary to discontinue use. One of our patient co-ordinators will go over this in detail with you prior to your procedure.
Is the procedure done under an anesthetic?
Yes, anesthesia is required because the HIFU treatment works with millimeter precision and not even the slightest movement is allowed. Your anesthesiologist will decide what is best for you. Since there is no cutting off body tissue and no loss of body fluids, anesthesia is light. Many patients breathe on their own.
Will I require other medications after treatment?
Yes. You will need to be on an antibiotic while you have a catheter due to the fact that there is a small risk that it can cause a urinary tract infection. You will also be given a prescription to reduce spasms, which can occur for a brief time after treatment. To alleviate pelvic cramping, sitting in a tub of warm water is helpful. You will also be given Flomax or a similar drug a few days before having your catheter removed to assist with voiding. Most patients usually do not need pain medications after this treatment.
Do some patients require repeat treatment?
There is no medical procedure that is 100% guaranteed, therefore some patients do require repeat treatment. The advantage of using HIFU is that it does not limit any future treatment options. Should treatment be necessary again, HIFU can be repeated or a patient can choose surgery or radiation. Surgery and radiation cannot be repeated, though.
Where will the procedure take place?
This procedure takes place in a surgery center. We have established surgery centers at each site where the machines are located in the United States.
I am taking hormones. Do I still qualify?
Yes, hormone therapy is not a contradiction to HIFU.
Will I require pain medication following treatment, and if so, what kind?
Patients usually don’t need pain medication after this procedure.
The rectal probe looks much larger than the standard biopsy/ultrasound probe.
Is that why anesthesia is required?
The procedure is completed under anesthesia which is required so the patient remains comfortable and still throughout the treatment. If the machine detects any movement, treatment stops immediately, so it is very important that you remain still. The rectal probe is not much larger than the standard biopsy/ultrasound probe.
How long will I have to wear a catheter after treatment?
A catheter will be required for 5-10 days following treatment as there will be swelling and edema of the treated prostate. Duration varies based on size of prostate and whether it was on one side or both sides. After the HIFU procedure, the destroyed prostate tissue is passed through the urine. It is possible that you will see sloughed material and possibly blood in the catheter bag. This is normal. The catheter can be removed by the patient’s home health nurse or physician.
Is there a possibility that I will need to wear my catheter longer than 10 days?
Some patients do require catheters longer than 10 days. This is more common in men with larger prostates and in men who experience voiding difficulty prior to treatment. Unfortunately, it is difficult to predict in advance, therefore reinsertion is sometimes necessary. If reinsertion is required, it is important that it is left in place for several days. In our US experience to date recatheterization has been required in less than 10% of men.
How will I know when to have my catheter removed?
This timeframe varies. Typically, 5-10 days is the most appropriate timeframe, in a hemi treatment versus a whole prostate treatment. Catheters are needed less in patients with smaller prostates and those who have had resection of the prostate but it is a process of trial and error.
Can I travel with my catheter?
Yes, although, you will not be able to drive with the catheter on the day of the treatment due to your anesthetic. The catheter may be a little uncomfortable to begin with, but sitting as a passenger is not a problem.
I have no problems urinating other than the fact that the stream is small, steady, and it takes much longer.Will the stream get stronger as the healing process continues?
After the procedure, swelling is very likely, which can lead to reduced stream lasting up to several weeks. If the stream continues to be of a reduced nature, treatment may be necessary due to ongoing sloughing of the prostate tissue.
When will the surgeon need to do laser or TURP?
It is recommended for patients with large prostates or those that have significant difficulty and straining before the procedure to undergo laser or TURP. This is to avoid the need for wearing a catheter due to sloughing of tissue. This may need to be discussed with your physician.
What are the chances of urinary incontinence?
Urinary incontinence is classified as grade 1, 2, or 3 depending on severity of the incontinence. Grade 1 is minimal stress incontinence which occurs only occasionally and occurs with severe straining. Grade 3 is severe or complete incontinence. After HIFU, Grade 1 incontinence occurs in less than 3% of cases. Grade 2 and 3 incontinence are very rare after HIFU occurring in less than 1% of cases performed as the primary treatment for prostate cancer. After failed radiation therapy or failed brachytherapy (radioactive seeds) up to 8% of patients will have Type 3 incontinence following salvage therapy with HIFU. These rates for treatment of primary prostate cancer and for treatment after failed radiation therapy and failed brachytherapy are both considerably better than for treatment with surgery or cryotherapy. Among patients who have semi or focal HIFU the incontinence rate is so low that it is similar to men with not treatment.
What types of activity can cause leakage?
Stressful activities that increase abdominal pressure, such as heavy lifting, can lead to leakage. This type of incontinence can be eliminated by Kegel exercises. The most severe type of incontinence may require use of incontinence pads, but is very rarely a problem with HIFU.
What are the chances of impotence?
This can be prevented by a nerve sparing treatment procedure. As with other procedures, HIFU is NOT 100% guaranteed to provide these results, but results are as good as nerve-sparing procedures. Many patients experience temporary erectile difficulties, and it is not possible to predict what the final result may be for several months post treatment. Among all treatments for prostate cancer HIFU has the lowest rate of impotence.
Why does HIFU have lower % of impotence?
The HIFU probe consists of two probes, one within the other. The imaging probe is high quality and it demonstrates the neurovascular bundle which contains the nerves of erection. The entire length of the bundle can be seen throughout it and can avoid damaging nerves. Many times we can treat one side of the prostate (semi or focal HIFU) if the cancer is diagnosed in its early stages. When Hemi treatment is done many times the impotence rates are similar to men who have no treatment.
How does HIFU prevent impotence because the ultrasound can visualize the nerve bundles?
HIFU treatment is done by layering heat lesions that are 1 to 2 millimeters in width. Visualization of the nerves allows the treatment lesion to be placed robotically and precisely. Very little heat is deposited next to the treatment area and this assures precise treatment of only the cancer areas and areas designated by the treating physician. Treatment can be applied right next to the nerves without causing injury to nerves. HIFU is the only treatment that can do this and has been tested and proven for over 15 years in Europe and 41 other countries.
I was told that my erectile function may come back after a certain amount of time, but that I may need Viagra or Cialis for a while. Approximately how long will it take for the damaged nerves to repair themselves?
In our experience in US, patients after hemi HIFU have regained erectile function in as little as 5 to 7 days after HIFU although whole gland treatments take longer. Usually after surgery it may take several months, and even up to one year, before outcomes can be evaluated, even though the injured nerves may regenerate quicker. Studies show that Viagra, Levitra, Cialis, etc. may assist in the healing process by increasing blood flow to the area. Therefore, you may wish to begin taking these medications twice a week once your catheter is removed to assist with the quality of erectile function.
How does the nerve sparing procedure work?
The nerves in neuromuscular bundles are what control erections. Precise localization of these bundles allows treatment within 2 to 3 mm of them. This technique is designed to preserve potency while also eliminating all cancer. The nerve sparing procedure can only be performed on prostates which have biopsies that are negative for cancer in the lobe of the gland where the nerve sparing procedure is performed but n the case of HIFU can be done even when cancer is in multiple areas.The only time it cannot be done is when cancer is involving the nerves.
If I were to have HIFU with a nerve sparing procedure and there was a recurrence, is it possible to have a radical prostatectomy with a nerve sparing procedure?
If a recurrence were to happen, HIFU would be the ideal treatment option. Surgery would be an option, but it would be much more difficult. Any time you combine treatment you lower the possibility of sparing nerves. If a recurrence were to happen, it is possible to try to save the nerves, but it is very likely that it would not be successful.This applies to whole gland treatment. In case of hemi HIFU it may be possible to spare the nerve on the untreated side.
Does the possibility of perineural invasion affect the HIFU procedure and nerve sparing?
No, this would not affect HIFU. Surrounding the nerve bundles is an open space that acts as a free passage for cancer cells to grow. The presence of cancer cells in the “perineural space” is one of the factors used in making the diagnosis of prostate cancer (benign tissue will not get into that space). This does not indicate that the cancer has spread outside of the prostate (lymph nodes) but it does suggest that the cancer has been present for a longer period of time. These nerves have nothing to do with erectile function so it does not interfere with the nerve sparing technique. The main nerves for erections are outside of the prostate in the neurovascular bundles.
Is there a chance that cancer could return some point once treatment is completed?
The goal of most prostate cancer treatments is to destroy all prostate tissue. If the entire prostate is not destroyed, there is a slight chance that a new tumor could develop or a recurrence could happen.
Is a repeat biopsy necessary, and if so, what do you biopsy if the prostate is no longer there?
Biopsies are only necessary if the PSA continues to be elevated or rising continuously. A repeat TRUS (trans-rectal ultrasound) will be required to visualize any remaining or recurrent prostate cancer and biopsy of the tissue will be performed. The biopsy is conducted on the scar tissue that is left behind. Negative biopsies indicate that cancer is no longer present.
What is a normal PSA?
A normal PSA is approximately 3.5 ng/ml. There have been studies that show that this may rise with age. Even more important than the actual PSA level is the rate of increase of PSA year after year. If you notice a rate of increase greater than 0.5, than you should discuss having a biopsy performed with your doctor. There are new guidelines on age specific PSA. This should be discussed with your urologist.
If my prostate cancer has a Gleason score of 8 or greater, will I need to have my seminal vesicles treated?
No, there is no evidence that treatment of the seminal vesicles will alter the course of your prostate cancer.
How much experience do you have with the technology?
Most of our doctors have treated many cases of HIFU and have been certified for using the technology. Some physicians have done over 100 cases. If any doctor needs more experience, he will be proctored by an experienced HIFU physician to make sure the procedure is done accurately.
I thought that HIFU had been in use for years, but my doctor tells me that it is “experimental”.
HIFU is relatively new in the United States, but it has been approved by the FDA as a safe and effective method treating prostate cancer. Thousands of treatments have been performed worldwide and the results have been published in worldwide peer-reviewed medical journals. Please contact us if you would like to review the peer-reviewed articles.