Humana Benign Prostatic Hyperplasia Treatments Form
Description
Benign prostatic hyperplasia (BPH) is caused by the abnormal growth of benign (noncancerous) prostate cells which enlarge the prostate gland. The gland may push against the bladder and urethra, causing lower urinary tract symptoms (LUTS) that include increased frequency of urination, hesitancy, nocturia (urinating at night), urgency and weak urine stream. These symptoms typically appear slowly and progress gradually over time. The likelihood of being affected by BPH increases with age and is common in males over 50 years of age.
There is no cure for BPH; treatment focuses on reducing the symptoms. Early nonsurgical management options include, but may not be limited to, the following:
- Alter lifestyle modifiable factors such as alcohol, caffeine and fluid intake and contributing medications when possible;
- AND/OR
- Prescription medication when medically appropriate and not contraindicated
If symptoms worsen, other treatment options include, but may not be limited to, the following:
Minimally Invasive Therapies
- Transurethral electrical vaporization of the prostate (TUEVP, TUVP, TVP) or transurethral vapor resection (TUVRP), is performed using a grooved roller-ball electrode with a large surface area that uses a cutting current. During the procedure, the ball is rolled over the prostate tissue multiple times to vaporize the tissue to the desired depth.
- Transurethral microwave thermotherapy (TUMT) heats the prostate using a microwave antennae mounted on a urethral catheter. The catheter is inserted into the urethra where low-energy or high-energy microwave heat destroys excess prostate tissue.
- Transurethral needle ablation (TUNA) or radiofrequency needle ablation (RFNA) uses low-level radiofrequency energy to treat the prostate. Using a cystoscope-like device, inserted through the urethra, twin needles are placed on either side of the prostate. Each needle emits radiofrequency energy that burns away a defined region of the prostate while shielding the urethra from heat. (Refer to Coverage Limitations section)
- Water Vapor Thermal Therapy (WVTT) (Rezum System) delivers sterile water vapor (steam) transurethrally directly into hyperplastic tissue. Heat is released as the vapor condenses, causing cell death.
Surgical Treatments
- Open or laparoscopic prostatectomy is performed when the prostate is greatly enlarged, when there are other complicating factors or if the bladder has been damaged and needs repair. In this procedure, an incision is made in the lower abdomen or perineum and the enlarged tissue is removed from the gland.
- Transurethral incision of the prostate (TUIP) does not remove prostate tissue. The urethra is widened by making several small cuts into the prostate and the neck of the bladder where the urethra and the bladder join. This reduces the pressure on the urethra and makes urination easier. TUIP is utilized when the prostate is not greatly enlarged.
- Transurethral resection of the prostate (TURP) is considered the gold standard for BPH treatment.
A resectoscope is inserted through the urethra to deliver fluids to the prostate during the procedure. The resectoscope uses an electrical loop to cut and vaporize tissue and seal blood vessels. The excised tissue is carried to the bladder and flushed out of the body by irrigation fluids.
Laser Therapy
Laser therapy is minimally invasive and uses laser generated heat to vaporize or coagulate obstructing prostate tissue. The device is passed through the urethra to the prostate using a cystoscope to deliver bursts of energy which destroy and shrink the prostate tissue. Laser surgery results in little blood loss. Types of laser therapy include, but may not be limited to:
- Contact laser ablation of the prostate (CLAP)
- Holmium laser ablation/enucleation/resection (HoLAP, HoLEP, HoLRP)
- Interstitial laser coagulation (ILC)
- Noncontact visual ablation (VLAP)
- Photoselective vaporization of the prostate (PVP)
- Thulium laser enucleation of the prostate (ThuLEP)
- Transperineal laser ablation (TPLA) involves percutaneous insertion of laser fibers, through the perineal skin and into the prostate. The delivery of laser generated heat is used to purportedly vaporize obstructing prostate tissue. The insertion of the fibers and monitoring are carried out under ultrasound guidance. The system has a dedicated transrectal ultrasound probe.
(Refer to Coverage Limitations section)
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 4 of 16
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Stents
Permanent urethral stents are placed into the urethra and expanded to relieve the obstruction.
(Refer to Coverage Limitations section)
Temporary (removable or biodegradable) prostatic urethral stents (iTind) perform in a similar manner and function but do not remain in the body permanently.
(Refer to Coverage Limitations section)
Additional Therapies
- Absolute ethanol injection into the prostate is a technique theorized to cause coagulation necrosis (chemoablation), which destroys the tissue.
- Cryosurgical ablation, also known as cryotherapy or cryosurgery, proposes the use of extreme cold temperatures by liquid nitrogen or argon gas to destroy tissue. When used internally, the liquid nitrogen or argon gas is circulated through a cryoprobe which freezes the surrounding cells. After the destroyed cells thaw, they are absorbed by the body.
- High-intensity focused ultrasound (HIFU) is the use of imaging ultrasound to deliver targeted high-intensity ultrasound that rapidly elevates the temperature in a precise focal zone. The increased tissue temperature is suggested to kill excess prostate tissue. Ablatherm, Sonablate and TULSA-PRO system are examples of US Food & Drug Administration (FDA) approved high-intensity ultrasound systems.
- Plasma kinetic vaporization (PKVP) or button procedure proposes the use of two mutually isolated electrodes (active and return) to form a complete circuit with the tissue lying between them. The electrical conduction path is formed by a saline irrigant. Radiofrequency energy is used to convert the conductive medium into a plasma field, which vaporizes tissue upon contact. A resectoscope, an instrument that contains the electrodes and is equipped with a wide-angle telescope, is passed retrograde through the urethra to the prostate.
- Prostate artery embolization aims to reduce the blood supply to the prostate gland causing tissue death and subsequent shrinkage.
(Refer to Coverage Limitations section)
The procedure is performed using a percutaneous transfemoral approach with microcatheters introducing embolization agents such as polyvinyl alcohol (PVA), gelatin sponge and other synthetic biocompatible materials which expand once delivered within the artery, blocking blood flow. Embosphere Microspheres and SwiftNINJA are examples of FDA- approved methods. (Refer to Coverage Limitations section)
Prostatic Urethral Lift (PUL)
is an implantable transprostatic tissue retractor system consisting of a delivery device inserted through the urethra, which then deploys an implant through the prostate. Implant increases urethral patency by providing prostate lobe tissue retraction while preserving the potential for future procedures. An example of an FDA-approved device is the UroLift System.
Transrectal thermotherapy
purportedly heats the prostate using a catheter inserted into the rectum. Various types of energy, such as microwave, radiofrequency or electrothermal, are delivered via the catheter to heat and thereby destroy excess prostate tissue. (Refer to Coverage Limitations section)
Transurethral balloon dilatation
involves the insertion of a balloon catheter through the urethra into the prostatic urethra where it is inflated, theoretically pushing back prostate tissue and stretching the urethra where it has been narrowed by the prostate. An example of this includes, but may not be limited to the Optilume Basic. The Optilume drug-coated balloon combines urethral dilation with circumferential topical delivery of paclitaxel. (Refer to Coverage Limitations section)
Transurethral ultrasound guided laser induced prostatectomy (TULIP)
is similar to TUIP except that cuts are made with a laser. Laser energy is delivered under ultrasound guidance, producing tissue necrosis. (Refer to Coverage Limitations section)
Water induced thermotherapy (WIT)
purportedly combines compression and high temperature to kill and shrink prostatic tissue surrounding the urethra. A heat-transmitting balloon catheter full of heated water (60 degrees Celsius) is introduced into the urethra, destroying prostate tissue. (Refer to Coverage Limitations section)
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 6 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
Waterjet ablation (AquaBeam)
is an endoscopic device intended to resect the prostate.
The system is guided robotically using transrectal ultrasound imaging enabling the removal of the enlarged prostate tissue using a pressurized fluid jet.
For information regarding Cialis (tadalafil), please refer to Cialis (tadalafil) Pharmacy Coverage Policy.
For information regarding Step Therapy, please refer to BPH Agents Pharmacy Coverage Policy.
Coverage Determination
Please refer to the member’s applicable pharmacy benefit to determine benefit availability and the terms and conditions of coverage for medication for the treatment of BPH.
Humana members may be eligible under the Plan for BPH treatment using the following methods when nonsurgical management has failed:
- Laparoscopic or open prostatectomy; OR
- Laser therapies, including the following:
- Contact laser ablation of the prostate (CLAP); OR
- Holmium laser ablation/enucleation/resection (HoLAP, HoLEP, HoLRP); OR
- Interstitial laser coagulation (ILC); OR
- Noncontact visual ablation (VLAP); OR
- Photoselective vaporization of the prostate (PVP); OR
- Thulium laser enucleation of the prostate (ThuLEP); OR
- Prostatic urethral lift (PUL) (UroLift) in an individual 45 years of age or older with prostate volume less than 100cc; OR
- Transurethral electrical vaporization of the prostate (TUEVP, TUVP, TVP) or transurethral vapor resection (TUVRP); OR
- Transurethral incision of the prostate (TUIP) in an individual with a prostate volume less than or equal to 30cc; OR
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 7 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
- Transurethral microwave thermotherapy (TUMT); OR
- Water Vapor Thermal Therapy (WVTT) (Rezum System) in an individual 50 years of age or older with a prostate volume between 30-80cc; OR
- Transurethral resection of the prostate (TURP); OR
- Waterjet ablation (AquaBeam) in an individual with a prostate volume between 30-80cc
Coverage Limitations
Humana members may NOT be eligible under the Plan for BPH treatment using any procedures other than those listed above including, but may not be limited to, the following:
- Absolute ethanol injection; OR
- Cryosurgical ablation; OR
- High-intensity focused ultrasound (HIFU); OR
- Permanent urethral stent; OR
- Plasma kinetic vaporization (PKVP); OR
- Prostate artery embolization; OR
- Temporary prostatic urethral stent (iTind); OR
- Transperineal laser ablation (TPLA); OR
- Transrectal thermotherapy; OR
- Transurethral balloon dilatation (eg, Optilume Basic or drug-coated balloon); OR
- Transurethral needle ablation (TUNA)/radiofrequency needle ablation (RFNA); OR
- Transurethral ultrasound guided laser induced prostatectomy (TULIP); OR
- Water induced thermotherapy (WIT)
These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language.
Background
Additional information about BPH may be found from the following websites:
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
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American Urological Association
National Library of Medicine
Medical Alternatives
Physician consultation is advised to make an informed decision based on an individual's health needs.
Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
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Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.
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- 52450 Transurethral incision of prostate
- 52601 Transurethral electrosurgical resection of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included)
- 52630 Transurethral resection; residual or regrowth of obstructive prostate tissue including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included)
- 52647 Laser coagulation of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included if performed)
- 52648 Laser vaporization of prostate, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)
- 52649 Laser enucleation of the prostate with morcellation, including control of postoperative bleeding, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, internal urethrotomy and transurethral resection of prostate are included if performed)
- 53850 Transurethral destruction of prostate tissue; by microwave thermotherapy
- 53852 Transurethral destruction of prostate tissue; by radiofrequency thermotherapy - Not Covered
- 53854 Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy
- 53855 Insertion of a temporary prostatic urethral stent, including urethral measurement - Not Covered
Transurethral destruction of prostate tissue; by microwave thermotherapy Transurethral destruction of prostate tissue; by radiofrequency thermotherapy Transurethral destruction of prostate tissue; by radiofrequency generated water vapor thermotherapy Insertion of a temporary prostatic urethral stent, including urethral measurement Prostatectomy, perineal, subtotal (including control of postoperative bleeding, vasectomy, meatotomy, urethral calibration and/or dilation, and internal urethrotomy)55801
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 10 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
- 55821 Prostatectomy (including control of postoperative bleeding, vasectomy, meatotomy, urethral calibration and/or dilation, and internal urethrotomy); suprapubic, subtotal, 1 or 2 stages
- 55831 Prostatectomy (including control of postoperative bleeding, vasectomy, meatotomy, urethral calibration and/or dilation, and internal urethrotomy); retropubic, subtotal
- 55880 Ablation of malignant prostate tissue, transrectal, with high intensity-focused ultrasound (HIFU), including ultrasound guidance - Not Covered
- 55899 Unspecified male genital procedures, not elsewhere classified
Unlisted Procedure, Male Genital System
Not Covered if used to treat any treatment outlined in Coverage Limitations section
CPT® Category III Code(s)
- 0421T Transurethral waterjet ablation of prostate, including control of post-operative bleeding, including ultrasound guidance, complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included when performed) with transurethral anterior.
- 0619T Cystourethroscopy with prostate commissurotomy and drug delivery, including transrectal ultrasound and fluoroscopy, when performed - Not Covered
- 0714T Transperineal laser ablation of benign prostatic hyperplasia, including imaging guidance - Not Covered
HCPCS Code(s)
- C2596 Probe, image guided, robotic, waterjet ablation
- 9739 Cystourethroscopy, with insertion of transprostatic implant; one to three implants
- Cystourethroscopy, with insertion of transprostatic implant; four or more implants
- Cystourethroscopy, with insertion of temporary prostatic implant/stent with fixation/anchor and incisional struts - Not Covered (C9769)
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 11 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
References
- American Urological Association (AUA). Guideline. Management of lower urinary tract symptoms attributed to benign prostatic hyperplasia. https://www.auanet.org. Published August 2021. Accessed January 18, 2023.
- ECRI Institute. Clinical Evidence Assessment. Aquabeam Robotic System (Procept BioRobotics Corp.) for treating benign prostatic hyperplasia. https://www.ecri.org. Published October 20, 2018. Updated September 29, 2022. Accessed January 17, 2023.
- ECRI Institute. Clinical Evidence Assessment. iTind system (Olympus America, Inc.) for treating benign prostatic hyperplasia. https://www.ecri.org. Published March 7, 2022. Accessed January 17, 2023.
- ECRI Institute. Clinical Evidence Assessment. Overview of two systems for treating benign prostatic hyperplasia. https://www.ecri.org. Published April 1, 2020. Accessed January 17, 2023.
- ECRI Institute. Clinical Evidence Assessment. Prostate artery embolization for treating benign prostatic hyperplasia. https://www.ecri.org. Published April 25, 2019. Updated September 16, 2022. Accessed January 17, 2023.
- ECRI Institute. Clinical Evidence Assessment. Rezum System (Boston Scientific Corp.) for treating benign prostatic hyperplasia. https://www.ecri.org. Published November 18, 2016. Updated January 12, 2022. Accessed January 17, 2023.
- ECRI Institute. Clinical Evidence Assessment. Transperineal laser ablation for treating benign prostatic hyperplasia. https://www.ecri.org. Published May 10, 2022. Accessed January 17, 2023.
- ECRI Institute. Clinical Evidence Assessment. UroLift system (NeoTract, Inc.) for treating benign prostatic hyperplasia. https://www.ecri.org. Published July 1, 2019. Accessed January 17, 2023.
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 12 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version.
Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
- ECRI Institute. Hotline Response (ARCHIVED). High-intensity focused ultrasound for treating benign prostatic hyperplasia. https://www.ecri.org. Published November 10, 2011. Accessed January 17, 2023.
- ECRI Institute. Hotline Response (ARCHIVED). Holmium laser enucleation versus transurethral resection of the prostate for treating benign prostatic hyperplasia. https://www.ecri.org. Published May 1, 2019. Accessed January 17, 2023.
- ECRI Institute. Hotline Response (ARCHIVED). Photoselective vaporization of the prostate for treating benign prostatic hyperplasia. https://www.ecri.org. Published May 12, 2004. Updated May 17, 2012. Accessed January 17, 2023.
- ECRI Institute. Hotline Response (ARCHIVED). Water-induced thermotherapy for treating benign prostatic hyperplasia. https://www.ecri.org. Published April 7, 2004. Updated May 18, 2012. Accessed January 17, 2023.
- ECRI Institute. Product Brief. Embosphere microspheres (Merit Medical Systems, Inc.) for prostate artery embolization to treat benign prostate hyperplasia. https://www.ecri.org. Published April 22, 2019. Accessed January 17, 2023.
- ECRI Institute. Product Brief. SwiftNinja steerable microcatheter (Merit Medical Systems, Inc.) for prostate artery embolization to treat benign prostate hyperplasia. https://www.ecri.org. Published April 30, 2019. Accessed January 17, 2023.
- ECRI Institute. Product Brief (ARCHIVED). Plasma-oval button (Olympus America) for treating benign prostatic hyperplasia. https://www.ecri.org. Published September 12, 2016. Accessed January 17, 2023.
- ECRI Institute. Product Brief (ARCHIVED). Spanner Prostatic Stent (SRS Medical) for maintaining urine flow after treatment for benign prostatic hyperplasia. https://www.ecri.org. Published April 20, 2018. Accessed January 17, 2023.
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 13 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
17. Hayes, Inc. Evolving Evidence Review. iTind (Olympus) for benign prostatic hyperplasia. https://evidence.hayesinc.com. Published March 3, 2022. Accessed January 17, 2023.
18. Hayes, Inc. Health Technology Assessment. Aquablation for treatment of benign prostatic hyperplasia. https://evidence.hayesinc.com. Published March 30, 2021. Updated March 21, 2022. Accessed January 17, 2023.
19. Hayes, Inc. Health Technology Assessment. Comparative effectiveness review of prostatic artery embolization (PAE) for treatment of benign prostatic hypertrophy (BPH). https://evidence.hayesinc.com. Published February 11, 2019. Updated January 20, 2022. Accessed January 17, 2023.
20. Hayes, Inc. Health Technology Assessment. Prostatic urethral lift (UroLift System) for treatment of symptoms associated with benign prostatic hyperplasia. https://evidence.hayesinc.com. Published June 9, 2020. Updated July 5, 2022. Accessed January 17, 2023.
21. Hayes, Inc. Health Technology Assessment. Rezum system (Boston Scientific Corp.) for benign prostatic hyperplasia. https://evidence.hayesinc.com. Published October 18, 2021. Updated December 9, 2022. Accessed January 17, 2023.
22. Hayes, Inc. Health Technology Brief (ARCHIVED). Bipolar plasmakinetic electrovaporization for benign prostatic hyperplasia (BPH). https://evidence.hayesinc.com. Published March 31, 2011. Updated April 1, 2013. Accessed January 17, 2023.
23. Hayes, Inc. Medical Technology Directory (ARCHIVED). Laser therapy for benign prostatic hyperplasia. https://evidence.hayesinc.com. Published March 5, 2010. Updated April 4, 2014. Accessed January 17, 2023.
Hayes, Inc. Medical Technology Directory (ARCHIVED). Transurethral microwave thermotherapy. https://evidence.hayesinc.com. Published August 23, 2007. Updated July 14, 2011. Accessed January 17, 2023.
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 14 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
25. Hayes, Inc. Medical Technology Directory (ARCHIVED). Transurethral needle ablation therapy. https://evidence.hayesinc.com. Published July 9, 2001. Updated September 18, 2006. Accessed January 17, 2023.
26. Hayes, Inc. Medical Technology Directory (ARCHIVED). Water-induced thermotherapy (WIT) for benign prostatic hyperplasia. https://evidence.hayesinc.com. Published October 7, 2002. Updated August 19, 2007. Accessed January 17, 2023.
27. MCG Health. Laser surgery, prostate. 26th edition. https://www.mcg.com. Accessed December 20, 2022.
28. MCG Health. Prostatectomy, transurethral resection (TURP). 26th edition. https://www.mcg.com. Accessed December 20, 2022.
29. MCG Health. Transurethral electrovaporization, prostate (TUVP). 26th edition. https://www.mcg.com. Accessed December 20, 2022.
30. MCG Health. Transurethral incision, prostate (TUIP). 26th edition. https://www.mcg.com. Accessed December 20, 2022.
31. MCG Health. Transurethral microwave therapy (TUMT). 26th edition. https://www.mcg.com. Accessed December 20, 2022.
32. MCG Health. Transurethral needle ablation (TUNA), prostate. 26th edition. https://www.mcg.com. Accessed December 20, 2022.
33. MCG Health. Water induced thermotherapy. 26th edition. https://www.mcg.com. Accessed December 20, 2022.
34. UpToDate, Inc. Surgical treatment of benign prostatic hyperplasia (BPH). https://www.uptodate.com. Updated December 2022. Accessed January 18, 2023.
35. US Food & Drug Administration (FDA). 510(k) summary: Ablatherm fusion. https://www.fda.gov. Published October 3, 2017. Accessed January 15, 2018.
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 15 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
36. US Food & Drug Administration (FDA). 510(k) summary: Optilume Basic Urological Balloon Dilation (Optilume Basic). https://www.fda.gov. Published January 2, 2020. Accessed April 27, 2020.
37. US Food & Drug Administration (FDA). 510(k) summary: Rezum system. https://www.fda.gov. Published April 19, 2016. Accessed January 15, 2018.
38. US Food & Drug Administration (FDA). 510(k) summary: Sonablate. https://www.fda.gov. Published December 21, 2016. Accessed January 12, 2017.
39. US Food & Drug Administration (FDA). 510(k) summary: SwiftNINJA Microcatheter. https://www.fda.gov. Published November 4, 2016. Accessed November 19, 2019.
40. US Food & Drug Administration (FDA). 510(k) summary: TULSA-PRO system. https://www.fda.gov. Published August 15, 2019. Accessed September 13, 2019.
41. US Food & Drug Administration (FDA). 510(k) summary: UroLift system. https://www.fda.gov. Published July 31, 2020. Accessed December 22, 2020.
42. US Food & Drug Administration (FDA). De novo summary: Aquabeam system. https://www.fda.gov. Published December 21, 2017. Accessed December 27, 2017.
43. US Food & Drug Administration (FDA). De novo summary: Embosphere microspheres. https://www.fda.gov. Published June 21, 2017. Accessed January 16, 2018.
44. US Food & Drug Administration (FDA). De novo summary: iTind system. https://www.fda.gov.
Published February 25, 2020. Accessed December 21, 2020.
45. US Food & Drug Administration (FDA). Premarket approval: Optilume urethral drug coated balloon. https://www.fda.gov. Published December 3, 2021. Accessed December 20, 2021.
Benign Prostatic Hyperplasia Treatments
Effective Date: 12/14/2023
Revision Date: 12/14/2023
Review Date: 03/01/2023
Policy Number: HUM-0459-034
Page: 16 of 16
Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.
46. US Food & Drug Administration (FDA). Premarket approval: The Spanner temporary prostatic stent. https://www.fda.gov. Published October 7, 2022. Accessed January 18, 2023.
47. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Optilume urethral drug coated balloon. https://www.fda.gov. Published December 3, 2021. Accessed December 20, 2021.