Rezum™

Q. WHAT CPT CODE IS USED TO BILL FOR THE REZŪM SYSTEM PROCEDURE?

A. All payers require CPT code 53854 when billing the Rezūm procedure. It is recommended that an insurance verification request be completed by the Rezūm Procedure Reimbursement Hotline prior to treatment. The Rezūm Procedure Reimbursement Hotline staff will contact the payer at your request and report back coverage details.

Q. DOES MEDICARE REIMBURSE FOR CPT CODE 53854?

A. All Medicare contractors reimburse for the Rezūm procedure. Payment varies by geographic locale.

Q. IS PRIOR AUTHORIZATION REQUIRED FOR THE REZŪM PROCEDURE?

A. Medicare does not allow prior authorization; however, some of the private payers will require it. The Rezūm Procedure Reimbursement Hotline staff can confirm and communicate the prior authorization process for the patient’s payer based on the benefit plan.

Q. HOW SHOULD CONSCIOUS SEDATION BE REPORTED IF USED IN THE PHYSICIAN OFFICE?

A. If conscious sedation is used in the physician office setting, an independent, trained observer must be present to monitor the patient’s status.

If the sedation is administered by the surgeon, it is reported using CPT codes 99152-99153. The intra-service time begins with the administration of the agent and concludes at the end of personal contact with the patient by the physician providing the sedation. Billing of these services requires continuous face-to-face attendance. Coverage and reimbursement for conscious sedation varies by the patient’s benefit plan and should be confirmed prior to the service.

Q. ARE OTHER PROCEDURES INCLUDED IN THE PAYMENT FOR CPT CODE 53854?

A. Related services are typically considered bundled and included in the payment for the procedure. There is a 90-day global period assigned to CPT code 53854.

Q. IN THE REZŪM PIVOTAL STUDY, WHAT PERCENTAGE OF PATIENTS WOULD HAVE REZŪM PERFORMED AGAIN IF THEIR SYMPTOMS WERE TO RECUR?

A. Patients were asked at their 3-month follow-up visit whether they would consider having the Rezūm procedure again if their symptoms were to recur. 120/134 (90%) are likely to have the treatment again if their symptoms recurred after 5 years.¹

Q. WHAT PERCENTAGE OF PATIENTS RECEIVED AN INTERVENTIONAL PROCEDURE WITHIN 4 YEARS POST-REZŪM?

A. Through 4 years, 6 of 135 (4.4%) patients underwent a secondary treatment for continued lower urinary tract symptoms. One patient had an undiagnosed/untreated intravesical protrusion, and as a result, had an open simple prostatectomy at 1 month, three patients had a plasma button transurethral vaporization of the prostate, and two were retreated with Rezūm. Four of the 6 patients who went on to a secondary treatment had an identified but untreated median lobe.²

Q. IN THE REZŪM PIVOTAL STUDY, WHAT WAS THE WASHOUT PERIOD FOR THE EXCLUDED MEDICATIONS?

• Antihistamines – 1 week prior to procedure unless there is documented evidence of stable dosing for last 6 months (no dose changes).¹
• Alpha blockers – 4 weeks prior to procedure.¹
• Type II, 5-alpha reductase inhibitor (e.g., finasteride (Proscar, Propecia) – 3 months prior to procedure.¹
• Dual 5-alpha reductase inhibitor (e.g., dutasteride (Avodart)) – 6 months prior to procedure.¹
• Estrogen, drug-producing androgen suppression, or anabolic steroids – 3 months prior to procedure.¹
• Daily dose PD5 Inhibitors (e.g.Viagra, Levitra or Cialis) – 4 weeks prior to procedure.¹
  

All patients had to remain off the excluded medications until the end of the Rezūm II Study (5 years post-procedure).

Q. WAS THERE ANY IMPACT TO SEXUAL FUNCTION OR RETROGRADE EJACULATION SEEN IN STUDY PARTICIPANTS?
A. Study results show that Rezūm has a positive safety profile with preservation of sexual function, and no late-occurring related adverse events or de novo erectile dysfunction reported at 4 years. 

Q. CAN PATIENTS ON ANTICOAGULANT MEDICATION BE TREATED WITH REZŪM?

A. During the Rezūm Pivotal Study, antiplatelet or anticoagulant medication had a 10 day pre- and post-procedure washout. There has been no data collected regarding this subset of patients and therefore, we recommend you follow your standard of care for minimally invasive procedures.

Dr. Lennart Wagrell’s standard of care for treating patients on anti-coagulants varied depending on the medication:

• Plavix – 7 day pre procedure washout
• Warfarin – 3 day pre procedure washout

All patients were able to resume their anti-coagulants immediately post procedure.

Q. CAN PATIENTS BE TREATED WITH REZŪM ON THEIR CURRENT BPH MEDICATION OR SHOULD THEY WASHOUT?

A. It is recommended that you follow your current protocol for treating patients on BPH medication with other minimally invasive procedures.

During the Rezūm Pivotal Study, all patients were washed out of their BPH medication to ensure the efficacy seen was from Rezūm alone. There has been no data collected on using Rezūm simultaneously with BPH medications and therefore, we recommend you follow your standard of care.¹

Q. CAN YOU USE REZŪM ON PATIENTS IN RETENTION?

A. 81% of urinary retention patients were able to void after an average of 28 days post-Rezūm.^3,4

Q. WHAT IS THE FLOW RATE OF THE STEAM AS IT ENTERS THE PROSTATE?

A. The flow rate of the steam is slightly above interstitial pressure.

Q. WHY IS USING LESS ENERGY WITH REZŪM BETTER THAN USING MORE ENERGY WITH ANOTHER PROCEDURE?

A. Water vapor energy is a more efficient form of energy. Unlike other treatments where a larger amount of energy is needed to conductively destroy cells using a heat gradient or vaporization, water vapor energy uniformly and instantaneously denatures cells, rendering them non-viable. This allows the body to then naturally resorb the treated tissue.

Q. WHAT IRRIGATION SOLUTION CAN YOU USE FOR REZŪM?

A. Labeling states 500-5000 mL of isotonic 0.9% sterile saline, hard or soft bottles should be used.

Q. CAN POST-RADIATION PATIENTS BE TREATED SAFELY WITH REZŪM?

A. Post-radiation patients were not included in the Rezūm Pivotal Study. There has been no data collected for this subset of patients and therefore, we recommend you follow your standard of care.

Q. WHAT WAS THE RECTAL TEMPERATURE OBSERVED DURING THE PROCEDURE?

A. Rectal temperature monitoring was done in 25 subjects in the Rezūm Pilot Study. Rectal Temperatures remained constant during the course of treatment for all 25 subjects. The mean rectal temperature observed was 37.03° C. No adverse events associated with rectal injury were observed among any of the 25 subjects.¹

Q. WHAT WAS THE URETHRAL TEMPERATURE OBSERVED DURING THE PROCEDURE?

A. The urethral temperature was not measured during the clinical studies. To keep the urethra and shaft of the device cool, there is a constant flow of room temperature (20–25° C) saline flush when the needle is deployed. The system also sends a small burst of saline flush through the device every 30 seconds during navigation and idle to ensure the shaft is cool while in use.

Q. CAN YOU TREAT THE MEDIAN LOBE WITHOUT DOING THE LATERAL LOBES?

A. Rezūm can treat the median lobe without treating the lateral lobes. Generally with BPH, the lateral lobes and median lobe all contribute to outflow obstruction. In the Rezūm Pivotal Study, a few median lobes became more prominent once the lateral lobes debulked, causing the physician to retreat the median lobe alone.

Q. HOW DOES THE RESORPTION PROCESS WORK IF THE VASCULARIZATION IS CLOSED?

A. Since Rezūm does not take out the entire transition zone, the blood vessels outside of the lesion, that run up to the treated tissue, are able to carry lymphocytes to the treated area. These lymphocytes engulf, enzymatically digest and break down the lesion which is then carried back through the blood stream where the body eliminates it. This process continues until the entire lesion is resorbed, moving from the outside of the lesion toward the inside.

Q. IF THE NEEDLE IS NOT PLACED DEEP ENOUGH INTO THE TISSUE AND THE WATER VAPOR ESCAPES INTO THE URETHRA, WILL THE URETHRA BECOME DAMAGED?

A. If the needle is placed too shallow and vapor reaches the urothelium, this tissue could potentially be devascularized and resorbed, resulting in asymmetrical healing or a divot in the area. Vapor that escapes into the prostatic urethra condenses immediately as it mixes with the room temperature saline flush (20–25° C) minimizing urethral impact.