rezūm system reimbursement guide - A Minimally Invasive ...€¦ · rezūm system reimbursement guide ... N13.9 Obstructive and reflux uropathy, ... and reduce prostate tissue associated

rezūm system reimbursement guide

JANUARY 2017

Reimbursement Support952-454-5361

[email protected]

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Reimbursement Support 952-454-5361 | [email protected] Page 2

table of contents

OVERVIEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3

Benign Prostatic Hyperplasia (BPH) . .. . .. . .. . .. . .. . .. . .. . 3

The Rezūm System . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . 3

Indications for Use . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . 3

CODING AND PAYMENT . . . . . . . . . . . . . . . . . . . .4

Diagnosis Coding .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . 4

Physician Coding and Payment . .. . .. . .. . .. . .. . .. . .. . .. . 6

Physician Billing in the Office .. . .. . .. . .. . .. . .. . .. . .. . .. . 7

Physician Billing in a Facility Setting . .. . .. . .. . .. . .. . .. . .. . 8

Outpatient Hospital Coding & Payment . . .. . .. . .. . .. . .. . .. . 9

Ambulatory Surgery Center (ASC) Coding & Payment . .. . .. . .. . 9

Inpatient Hospital.. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . .. . 9

BENEFITS AND COVERAGE . . . . . . . . . . . . . . . . 10

The Prior Authorization Process . .. . .. . .. . .. . .. . .. . .. . .. 10

FREQUENTLY ASKED QUESTIONS . . . . . . . . . . . . 11

SAMPLE PRIOR AUTHORIZATION REQUEST . . . 12

SAMPLE LETTER OF MEDICAL NECESSITY . . . . 13 THE REZŪM SYSTEM BIBLIOGRAPY . . . . . . . . . 14

REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

DisclaimerThe information in this guide is provided for the benefit of NxThera customers and offers general coverage, coding and payment information for procedures associated with the use of the Rezūm System. The information provided is intended to facilitate appropriate coverage and reimbursement for providers in various sites of service. Users of this guide should understand that this is general information, not legal guidance nor is it advice about how to code completely or submit any particular claim for payment. Information provided is not intended to increase or maximize reimbursement by any payer. The information provided represents NxThera’s understanding of current reimbursement policies. The suggested codes are to be used only to facilitate appropriate coding and should not be construed as recommended guidelines in the establishment of policy or practice. Any descriptions of services contained in this guide are for the purpose of illustrating typical clinical services and not intended to represent practice guidelines or standards of care. NxThera makes no representations or warranties with respect to the contents of this guide and disclaims any implied guarantee or warranty of fitness for any particular purpose. NxThera will not be liable to any individual or entity for any losses or damages that may be incurred by the use of this guide. Furthermore, NxThera specifically disclaims any liability or responsibility for the results or consequences of any actions taken in reliance on the statements, opinions or suggestions in this guide. It is always the provider’s responsibility to determine coverage and submit appropriate codes and charges for services rendered. Providers should check and verify current policies and requirements with the payer for any particular patient. It is important to verify coverage for each patient as policies and guidelines can vary by payer and plan. The key in all coding and billing to payers is to be truthful and not misleading and make full disclosures to the payer about how the product has been used and the procedures necessary to use the product when seeking reimbursement for any product or procedure. In all cases, services billed must be medically necessary, actually performed as reported and appropriately documented.

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overview

BENIGN PROSTATIC HYPERPLASIA (BPH)

BPH is a localized, enlargement of the prostate gland characterized by a proliferation of tissue within the prostate. This

excess growth of prostate tissue compresses and obstructs the urethra, reducing the flow of urine from the bladder and

sometimes blocking it entirely.

THE REZŪM SYSTEM

The Rezūm System includes a handheld delivery device and generator. The system uses radiofrequency (RF) power to

create thermal energy in the form of sterile water vapor (steam). During this transurethral needle ablation procedure,

controlled doses of the wet thermal energy created with RF power are convectively delivered directly to targeted

areas of the prostate gland through the tissue interstices. Condensation releases the stored thermal energy of the

RF water vapor directly against the walls of the tissue cells within the treatment zone, immediately denaturing the

cell membranes, and causing almost instantaneous tissue cell death. The body’s immune system response causes this

denatured tissue to be resorbed over a matter of weeks, and this reduction in hyperplastic prostate tissue volume

reduces the obstruction of the urethra, relieving the lower urinary tract symptoms associated with BPH and enabling

improved urinary flow.

INDICATIONS FOR USE

The Rezūm System has been cleared by the FDA to relieve symptoms, obstructions, and reduce prostate tissue associated

with BPH. It is indicated for men ≥ 50 years of age with a prostate volume ≥ 30cm3 ≤ 80cm3. The Rezūm System is also

indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe.

The transurethral needle ablation procedure delivers targeted, controlled doses of thermal energy in the form of sterile water vapor, created using RF power, directly to the region of the prostate gland with the obstructive tissue. The number of treatments varies depending on the prostate size.

BEFORE AFTERTREATMENT

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HYPERPLASTICTISSUE

PROSTATE

URETHRA

BLADDER

HYPERPLASTICTISSUE

PROSTATE

URETHRA

BLADDER

PROSTATE

URETHRA

BLADDER

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coding and payment

This guide has been developed to assist you in reporting radiofrequency thermotherapy procedures to treat BPH using

the Rezūm System. It is important to understand that coding is specific to the procedure or services being performed,

not to the device being used. Ultimately it is the provider’s responsibility to choose codes that accurately describe the

patient’s condition and the procedure or services performed.

DIAGNOSIS CODING

The following diagnosis codes may be appropriate to describe a patient’s BPH condition. Complications and other

underlying conditions should also be reported. These diagnosis codes provide the basis for establishing why the BPH

treatment is needed and thus, establishing medical necessity for the treatment.

ICD-10-CM Dx Code*

Benign Prostatic Hyperplasia

ICD-10-CM Description

N40.0 Enlarged prostate without lower urinary tract symptoms

N40.1 Enlarged prostate with lower urinary tract symptoms

N40.2 Nodular prostate without lower urinary tract symptoms

N40.3 Nodular prostate with lower urinary tract symptoms

N13.9 Obstructive and reflux uropathy, unspecified

R33.9 Retention of urine, unspecified

R39.14 Feeling of incomplete bladder emptying

R33.0 Drug induced retention of urine

R33.8 Other retention of urine

R32 Unspecified urinary incontinence

N39.41 Urge incontinence

N39.3 Stress incontinence (female) (male)

N39.42 Incontinence without sensory awareness

N39.44 Nocturnal enuresis

N39.45 Continuous leakage

N39.490 Overflow incontinence

N39.498 Other specified urinary incontinence

R35.0 Frequency of micturition

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ICD-10-CM Dx Code*

Associated Symptoms ICD-10-CM Description

R35.1 Nocturia

R39.12 Poor urinary stream

R39.15 Urgency of urination

R39.11 Hesitancy of micturition

R39.16 Straining to void

R39.19 Other difficulties with micturition

*ICD-10-CM 2017. American Medical Association, Chicago, IL. 2016

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PHYSICIAN CODING & PAYMENT

Physicians and other providers use CPT codes to report procedures and services. Medicare reimburses CPT codes

under a fee schedule based on the Relative Value Units (RVUs) assigned to each code. Private payers may base their

reimbursement rates on the RVUs published by Medicare, or on other provider contracted and/or negotiated amounts.

The Rezūm System uses radiofrequency power to create thermal energy. This thermal energy ablates the targeted

prostate tissue during a series of treatments delivered during each procedure. NxThera sought guidance on appropriate

coding for the radiofrequency thermotherapy ablation procedure using the Rezūm System through the American

Urological Association’s (AUA) Coding & Reimbursement Committee (CRC). Based on their thorough review, the AUA CRC

confirmed the procedure using the Rezūm system may be reported using CPT code 53852, transurethral destruction

of prostate tissue; by radiofrequency thermotherapy.* BPH treatment procedures using either the Prostiva™ or Rezūm

devices are appropriately reported with CPT code 53852 because CPT codes are developed to describe

procedures and services, not specific to any particular device or product brand.

To report the Rezum procedure on medical claims, use CPT® code 53852 Transurethral destruction of prostate tissue; by

radiofrequency thermotherapy. The Rezum System uses radiofrequency energy to transform sterile water into stored thermal

energy in the form of vapor, or steam. This water vapor is convectively delivered directly into the obstructive prostate tissue

that causes BPH, where condensation releases enough thermal energy to denature the targeted prostate tissue cells to cause

necrosis. The treated tissue is absorbed by the body’s natural immune system. It is intended to relieve symptoms, obstruction,

and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is also indicated for treatment of prostates

with hyperplasia of the central zone and/or a median lobe.

https://www.auanet.org/resources/biopsy-procedures.cfm

* American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. https://www.auanet.org/resources/biopsy-procedures.cfm

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PHYSICIAN BILLING IN THE OFFICE

Codes for the radiofrequency thermotherapy ablation procedure to treat BPH and conscious sedation services are

included below.

CPT Code*

Description2017 Medicare

National Average†

Individual Non-Facility

RVUs‡

Total Non- Facility

RVUs‡

53852§

Transurethral destruction of

prostate tissue; by radiofrequency

thermotherapy

$1,952

Work: 10.83

Non-Facility Practice

Expense: 42.36

Malpractice: 1.20

54.39

Conscious Sedation

99152

Moderate sedation services

provided by the same physician

or other qualified health care

professional performing the

diagnostic or therapeutic service

that the sedation supports,

requiring the presence of an

independent trained observer to

assist in the monitoring of the

patient’s level of consciousness

and physiological status; initial

15 minutes of intraservice time,

patient age 5 years or older

$52

Work: 0.25


Expense: 1.18

Malpractice: 0.02

1.45

99153

Each additional 15 minutes

intraservice time (list separately

in addition to code for primary

service)

$11

Work: 0.00


Expense: 0.30

Malpractice: 0.01

0.31

* Current Procedural Terminology 2017, American Medical Association. Chicago, IL 2016. CPT is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT®) is copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply.† Refer to the CMS website for current information on the Medicare Fee Schedule for your specific area at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PFSlookup/index.html‡ Medicare Physician Fee Schedule Final Rule, Federal Register (81 Fed Reg, No. 220) November 15, 2016, 42 CFR Parts 405, 410, 411, et al.§ American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. https://www.auanet.org/resources/biopsy-procedures.cfm

If conscious sedation is used during an office based, RF thermotherapy BPH ablation procedure, an independent,

trained observer is required to be present to monitor the patient’s status. These services may be reported using CPT

codes 99152-99153. The intraservice 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.

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PHYSICIAN BILLING IN A FACILITY SETTING

Codes for the radiofrequency thermotherapy ablation procedure to treat BPH and conscious sedation are included below.

* Refer to the CMS website for current information on the Medicare Fee Schedule for your specific area at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PFSlookup/index.html† Medicare Physician Fee Schedule Final Rule, Federal Register (81 Fed Reg, No. 220) November 15, 2016, 42 CFR Parts 405, 410 and 411 et al.‡ American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. https://www.auanet.org/resources/biopsy-procedures.cfm

When the radiofrequency thermotherapy ablation procedure is performed in an outpatient hospital or ambulatory

surgery center (ASC) and conscious sedation is administered by a second physician or other qualified healthcare

professional, these services are reported using CPT codes 99156-99157. 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.

CPT Code*

Description2017 Medicare

National Average†

Individual Facility RVUs‡

Total Facility RVUs‡

53852§

Transurethral destruction of

prostate tissue; by radiofrequency

thermotherapy

$645

Work: 10.83

Facility Practice

Expense: 5.94

Malpractice: 1.20

17.97

Conscious Sedation

99156

Moderate sedation services

provided by a physician or other

qualified health care professional

other than the physician or other

qualified health professional

performing the diagnostic or

therapeutic service that the

sedation supports, initial 15

minutes of intraservice time,

patient age 5 years or older

$77

Work: 1.65

Facility Practice

Expense: 0.35

Malpractice: 0.15

2.15

99157

Each additional 15 minutes

intraservice time (list separately

in addition to code for primary

service)

$59

Work: 1.25

Facility Practice

Expense: 0.27

Malpractice: 0.11

1.63

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Reimbursement Support 952-454-5361 | [email protected]

OUTPATIENT HOSPITAL CODING & PAYMENT

The claim submission from the hospital will include all CPT codes that reflect the BPH treatment services delivered to

the patient, and reflects the supplies and devices used during the delivery of those services. The hospital bill includes all

overhead costs for the BPH treatment services including support staff time and the Rezūm device.

Hospital outpatient departments (HOPD) are reimbursed by Medicare under the Ambulatory Payment Classification (APC)

system in which a CPT is assigned to an APC. Private payers typically reimburse the HOPD per their contracted rates.

CPT Code Description APC2017 Medicare

National Average*

53852†Transurethral destruction of prostate

tissue; by radiofrequency thermotherapy5375 $3,483

CPT Code Description2017 Medicare

National Average*

53852†Transurethral destruction of prostate

tissue; by radiofrequency thermotherapy$1,520

AMBULATORY SURGERY CENTER (ASC) CODING & PAYMENT

Medicare reimburses ASCs according to a fee schedule assigned to each individual CPT code. Private payers may or

may not follow this same payment policy, but generally reimburse the ASC at their contracted rates.

* OPPS and ASC Final Rule, Federal Register (81 Fed Reg, No. 219) November 14, 2016, 42 CFR Parts 414, 416, and 419 et al. † American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. https://www.auanet.org/resources/biopsy-procedures.cfm‡ ICD-10-PCS 2017. American Medical Association, Chicago, IL 2016.§ 2017 DRG Expert. Ingenix, St. Anthony Publishing/Medicode. Salt Lake City, 2016.**IPPS Final Rule, Federal Register (81 Fed Reg, No. 162) August 22, 2016, 42 CFR Parts 405, 412, 413, et el.

ICD-10-PCS Procedure

Code‡

Definition

0V507ZZ Destruction of prostate, via natural or artificial opening

INPATIENT HOSPITAL

Medicare pays for inpatient care through its Medicare Severity Diagnosis Related Group (MS-DRG) system. Each

inpatient episode of care is assigned to a single MS-DRG, primarily on the basis of patient diagnosis, the presence or

absence of complicating conditions at time of admission, and surgical ICD-10-PCS procedures performed during the hos-

pitalization. Possible MS-DRGs for the Rezūm procedure are listed below.

MS-DRG§ Description FY2017 Medicare National Average**

0713 Transurethral prostatectomy with CC/MCC $9.510

0714 Transurethral prostatectomy without CC/MCC $5,015

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benefits and coverage

THE PRIOR AUTHORIZATION PROCESS

MEDICARE

Since Medicare does not have a process to review prior authorization requests, it is up to the provider to determine

coverage guidelines either by checking an individual payer’s website or contacting the payer directly. According to the

American Urological Association the treatment of BPH by radiofrequency thermotherapy is not new and is appropriately

reported with CPT code 53852. Medicare Administrative Contractors (MACs) are managing BPH benefits within their

individual jurisdictions. You are advised to check your MACs medical policy and coding articles for any specific guidance

on the reporting and coverage of BPH procedures.

COMMERCIAL PAYERS

Prior authorization, sometimes referred to as “pre-certification,” is the process used to confirm if a patient’s proposed

service or procedure is medically necessary. Whenever possible, prior authorization should occur before a procedure

is provided. You are advised to check with a patient’s individual health plan for their policy on prior authorization for

reporting procedures using CPT code 53852. Included in this Reimbursement Guide are sample letters which may be

used at different points during this process.

STEP 1: Allow up to 30 days for the payer to process the request

STEP 2: Allow an additional 30-45 days for each level of appeal

Up to four months may lapse before �nal approval

STEP 1

Follow payer process to request prior

authorization (or pre-determination)

of CPT code 53852.

Include:

• Patient history and medical

necessity for the procedure

• CPT and diagnosis codes

PRIOR AUTHORIZATION REQUEST

STEP 2

If the payer does not approve the

request for CPT 53852, the surgeon

and the patient may write appeal letters

to the payer.

If the appeal is denied, the patient

may request an external review with an

Independent Review Organization (IRO).

APPEALS PROCESS

STEP 3

Once authorization has been approved

by the payer, you may proceed with

the thermotherapy ablation procedure

and billing the payer.

PROCEDURE

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frequently asked questions

Current Procedural Terminology 2017, American Medical Association . Chicago, IL 2016 . CPT is a registered trademark of the American Medical Association . Current Procedural Terminology (CPT®) is copyright 2016 American Medical Association . All Rights Reserved . Applicable FARS/DFARS apply .

* American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. https://www.auanet.org/resources/biopsy-procedures.cfm

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Q . WHAT IS THE CPT CODE FOR THE REZŪM SYSTEM?

A. In December 2014, the American Urological Association’s Coding and Reimbursement Committee determined that CPT code 53852 (Transurethral destruction of prostate tissue; by radiofrequency thermotherapy) should be used to report the transuretheral needle ablation procedure using the Rezūm System.1

To report the Rezum procedure on medical claims, use CPT® code 53852 Transurethral destruction of prostate tissue; by radiofrequency thermotherapy. The Rezum System uses radiofrequency energy to transform sterile water into stored thermal energy in the form of vapor, or steam. This water vapor is convectively delivered directly into the obstructive prostate tissue that causes BPH, where condensation releases enough thermal energy to denature the targeted prostate tissue cells to cause necrosis. The treated tissue is absorbed by the body’s natural immune system. It is intended to relieve symptoms, obstruction, and reduce prostate tissue associated with benign prostatic hyperplasia (BPH). It is also indicated for treatment of prostates with hyperplasia of the central zone and/or a median lobe.

https://www.auanet.org/resources/biopsy-procedures.cfm

Q . DOES MEDICARE COVER CPT CODE 53852?

A. Most Medicare Administrative Contractors (MACs) consider radiofrequency thermotherapy ablation reported using CPT code 53852 medically necessary for treating patients with BPH. Please check with your individual MAC Local Coverage Decision for specific coverage guidelines.

Q . DO PRIVATE PAYERS COVER CPT CODE 53852?

A. Most payers consider CPT code 53852 medically necessary for patients with benign prostatic hypertrophy (BPH). Providers should always verify a patient’s benefits and any prior authorization requirements prior to scheduling a procedure.

Q . IS PRIOR AUTHORIZATION OR PRE-CERTIFICATION REQUIRED FOR THE REZŪM SYSTEM?

A. The Rezūm System is a technology used to perform the transurethral RF thermotherapy procedure to treat

BPH, and is reported using CPT code 53852. For the majority of payers, this procedure code is not on their prior authorization list. It is advised, however, that you check with patients’ individual health plans for their policy on prior authorization and pre-certification requirements for CPT code 53852.If a patient’s payer requires prior authorization, this should occur prior to the procedure being provided. Remember you are seeking authorization for the procedure under CPT code 53852, not for the specific device being used in the procedure . NxThera can provide information that will help you with this process, including sample letters. Should you need assistance, please contact 952-454-5361.

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

A. If conscious sedation is used during an office based, RF thermotherapy BPH ablation procedure, an independent, trained observer is required to be present to monitor the patient’s status. When these services are provided by the surgeon they may be 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.

Q . ARE OTHER PROCEDURES INCLUDED IN THE PAYMENT FOR CPT CODE 53852?

A. CPT code 53852 includes administration of a prostate block and transrectal ultrasound, if performed. These services should not be reported separately as they are considered bundled and included in the payment for the surgical procedure.

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SAMPLE PRIOR AUTHORIZATION REQUEST – CPT 53852

In lieu of a prior authorization request form, a physician can submit a formal letter requesting a prior authorization. The following letter can be modified with patient- and provider-specific information and attached to written prior authorization requests for the procedure:

[Insert Date]

VIA FACSIMILE: [insert insurer’s prior authorization fax number]

[Insert Health Insurer Name]

[Insert Street Address]

[Insert City, State Zip]

RE: Prior Authorization Request for [Patient’s Name/insurance I.D. Number]

To Whom It May Concern:

This letter is to request prior authorization for radiofrequency thermotherapy ablation of the prostate. I am writing on

behalf of [patient’s name], who suffers from [insert patient diagnosis]. He has been on BPH drug medications for [time

period] and these are not providing symptom relief. Therefore, I would like my patient to undergo a transurethral proce-

dure that uses thermal energy created with radiofrequency power to treat obstructive prostate tissue by delivering tar-

geted, controlled doses of thermal energy directly to the prostate gland tissue. The prostate tissue cell membranes are

denatured causing immediate cell death, and the necrotic tissue is absorbed over time by the body’s immune system

response. This treatment results in a reduction in the volume of obstructive prostate tissue, relieving the

symptoms of BPH by reducing the compression of the urethra.

Transurethral radiofrequency thermotherapy ablation of the prostate to treat BPH is the best option for my patient. It

enables a targeted and controlled treatment of the enlarged prostate tissue that is causing his BPH, and is designed to

minimize post-procedure complications.

I will perform this procedure in the [insert setting of care]. The procedure for [patient name] is scheduled for [date].

I will be reporting the following CPT code for performance of this procedure: 53852 (Transurethral destruction of

prostate tissue; by radiofrequency thermotherapy).

I request confirmation that this procedure is a covered benefit, and that associated professional fees will be covered.

If you require additional information, please contact me at [insert telephone number].

Sincerely,

[Physician Name]

[Provider number]

[Street Address]

[City, State Zip]

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SAMPLE LETTER OF MEDICAL NECESSITY – CPT 53852

The following letter can be modified with patient- and provider-specific information and used to appeal a denial for prior authorization of the procedure for the treatment of BPH:

[Insert Date]

VIA FACSIMILE: [insert insurer’s prior authorization fax number]

[Insert Health Insurer Name]

[Insert Street Address]

[Insert City, State Zip]

RE: Appeal of Prior Authorization Denial for [Insert Patient’s Name/Insurance I.D. Number]

To Whom It May Concern:

I am writing on behalf of [patient’s name], who suffers from [insert patient diagnosis]. I am writing to request that you

reconsider your previous denial of the prior authorization for transurethral radiofrequency thermotherapy ablation of the

prostate to treat BPH. [Describe the patient’s current status and intended treatment pathway.]

As [patient’s name]’s treating physician, I believe this procedure is the best option to treat this patient’s BPH. He

has been on BPH drug medications for [time period] and these are not providing symptom relief. I have scheduled

the procedure for [date] in anticipation of a positive response from you. The following CPT code will be reported in

connection with performing this procedure: 53852 (transurethral destruction of prostate tissue; by radiofrequency

thermotherapy).

Radiofrequency thermotherapy ablation is a standard procedure for treating BPH. It is my professional preference to

use this procedure which enables a targeted and controlled treatment of the enlarged prostate tissue. This office-based/

outpatient therapy can be conducted under local anesthesia, avoids complications associated with other BPH treatments

and has clinically proven results with symptom improvement in as soon as two weeks1.

I request confirmation as soon as possible that you will respect my professional recommendation and preference to

perform this procedure with the prior authorization requested. I am very happy to discuss this request. Please contact

me at [insert telephone number].

Sincerely,

[Physician Name]

[Provider number]

[Street Address]

[City, State Zip]

1 McVary KT, Gange SN, Gittelman MC, et al. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. The Journal of Urology. 2016;195(5):1529-1538. doi:10.1016/j.juro.2015.10.181.

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the rezūm system bibliography

MANUSCRIPTS

1. Roehrborn CG, Gange SN, Gittelman MC et al. Convective radiofrequency water vapor thermal therapy with Rezūm

System: Durable two-year results of randomized controlled and prospective crossover studies for treatment of lower

urinary tract symptoms due to benign prostatic hyperplasia. J Urol 2017. In Press..

2. McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky

J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate

Convective Water Vapor Energy (WAVE) Ablation: A Multicenter, Randomized, Controlled Study for Treatment of

Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol 2016;195:1529-39.

3. Dixon C, Rijo Cedano E, Pacik D, Vit V, Varga G, Wagrell L, Tornblom M, Mynderse L, Larson T. Efficacy and Safety of

Rezūm System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia.

UROLOGY. 2015;86:1042-1047.

4. Mynderse LA, Hanson D, Robb R, Pacik D, Vit V, Varga G, Wagrell L, Tornblom M, Rido Cedano E, Woodrum D, Dixon

CM, Larson TR. Rezūm System Water Vapor Treatment for Lower Urinary Tract Symptoms/Benign Prostatic

Hyperplasia: Validation of Convective Thermal Energy Transfer and Characterization with Magnetic Resonance

Imaging and 3D Renderings. UROLOGY. 2015;86:122-127.

5. Dixon CM, Cedano ER, Mynderse LA, Larson TR. Transurethral convective water vapor as a treatment for lower

urinary tract symptomatology due to benign prostatic hyperplasia using the Rezūm® system: evaluation of acute

ablative capabilities in the human prostate. Res Reports Urol. 2015;7:13-18.

REVIEW ARTICLES

1. Shore ND. An outcomes review of minimally invasive transurethral convective water vapor energy (WAVE) therapy

for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Curr Bladder Dysfunct Rep

2016;11:153-159.

2. Dixon C, Larson T, Hoey M. The Rezūm System: Minimally invasive treatment for BPH using water vapor (steam): why

consider it? Curr Bladder Dysfunct Rep 2015;10:156-159.

3. Ebbing J, Bachmann A. Anesthesia-free procedures for benign prostate obstruction: worth it? Curr Opin Urol

2015;25:32–39.

ABSTRACTS

1. Dixon C, Rijo Cedano E, Pacik D, Vit V, Varga G, Mynderse L, Larson, T. Convective Water Vapor Energy (WAVE)

Ablation: Two-Year Results Following Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic

Hyperplasia. Abstract ID 16-5612. American Urological Association Annual Meeting 2016, San Diego, California.

2. McVary K, Gange, S, et al. Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia with

Convective Water Vapor Energy Ablation: Preserved Erectile and Ejaculatory Function. Abstract ID 16-1219. American

Urological Association Annual Meeting 2016, San Diego, California.

3. McVary K, Roehrborn C, et al. Using the Thermal Energy of Convectively Delivered Water Vapor for the Treatment

of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia: The Rezūm II Study. Abstract #15-8068.

Plenary II Late-Breaking Abstract Session. American Urological Association Annual Meeting 2015, New Orleans,

Louisiana.

4. Mynderse L, Hanson D, Robb R, Rijo Cedano E, Pacik D, Vit V, Varga G, Larson T, Dixon C. Rezūm® System Water

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Vapor Treatment for Benign Prostatic Hyperplasia: Characterization with Magnetic Resonance Imaging and 3D

Rendering. Abstract #1890. American Urological Association Annual Meeting 2014, Orlando, Florida.

5. Wagrell L, Tornblom, M. Transurethral Water Vapor Therapy for BPH; A Single Center’s Experience Using the Rezūm®

System in an Office-based Setting. Abstract #1817. American Urological Association Annual Meeting 2014, Orlando,

Florida.

6. Dixon C, Rijo Cedano E, Pacik D, Vit V, Varga G, Mynderse L, Larson, T. Transurethral Water Vapor Therapy for BPH;

1-year Clinical Results of the First-In-Man and Rezūm® I Clinical Trials Using the Rezūm® System. Abstract #1816.

American Urological Association Annual Meeting 2014, Orlando, Florida.

7. Wagrell L, Tornblom, M. Transurethral Water Vapor Therapy for BPH; A Single Center’s Experience Using the Rezūm®

System. Abstract #234. European Association of Urology 2014, Stockholm, Sweden.

8. Mynderse L, Hanson D, Robb R, Rijo Cedano E, Pacik D, Vit V, Varga G, Larson T, Dixon, C. Characterizing Rezūm®

System Water Vapor Treatments for Benign Prostatic Hyperplasia with Serial Magnetic Resonance Imaging and 3D

Rendering. Abstract #230. European Association of Urology 2014, Stockholm, Sweden.

9. Dixon C, Rijo Cedano E, Pacik D, Vit V, Varga G, Mynderse L, Hanson D, Larson T. Transurethral High Energy Water

Vapor Therapy for BPH; Initial Clinical Results of the First-In-Man and Rezūm™ 1 Clinical Trials Using the Rezūm™

System. Journal of Endourology 2013, 27 (s1): A340. Abstract nr MP23-13.

10. Dixon C, Rijo Cedano E, Pacik D, Vit V, Varga G, Mynderse L, Hanson D, Larson T. Serial MRI and 3D Rendering

Following Treatment of BPH Using High Energy Water Vapor Therapy and the Rezūm™ System; Initial Results from

the First-In-Man and Rezūm™ 1 Clinical Trials. Journal of Endourology 2013, 27 (s1): A69. Abstract nr MP03-08.

11. Dixon C, Pacik D, Huidobro C, Rijo Cedano E, Mynderse L, Hanson D, Hoey M, Larson T. Preliminary Data Following

Treatment with Vapor for BPH: The Rezūm System. Abstract #1476. World Congress of Endourology 2012, Istanbul,

Turkey.

12. Dixon C, Rijo Cedano E, Pacik D, Vit V, Varga G, Mynderse L, Hanson D, Larson T. Transurethral Water Vapor Therapy

for BPH; Initial Clinical Results of the First-In-Man and Rezūm I Pilot Study. Abstract #631. European Association of

Urology 2013, Milan, Italy.

13. Dixon C, Huidobro C, Rijo Cedano E, Hoey M, Larson T. Acute Effects in the Human Prostate Following Treatment

with High-Calorie Water Vapor (Rezūm). Abstract #0838. World Congress of Endourology 2012, Istanbul, Turkey.

WHITE PAPERS

1. Water Vapor for Tissue Ablation. Hoey MF. March 2009.

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Reimbursement Support 952-454-5361 | [email protected]

referencesCurrent Procedural Terminology 2017, American Medical Association. Chicago, IL 2016. CPT is a registered trademark

of the American Medical Association. Current Procedural Terminology (CPT®) is copyright 2016 American Medical

Association. All Rights Reserved. Applicable FARS/DFARS apply.

Medicare Physician Fee Schedule Final Rule, Federal Register (81 Fed Reg, No. 220) November 15, 2016, 42 CFR Parts

405, 410, 411, et al.

OPPS and ASC Final Rule, Federal Register (81 Fed Reg, No. 219) November 14, 2016, 42 CFR Parts 414, 416, and 419

et al.

Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective

Payment System Policy Changes and Fiscal Year 2016 Rates Final Rule, Federal Register (81 Fed Reg, No. 162) August

22, 2016, 42 CFR Parts 405, 412, 413, et al.

American Urological Association: Prostate Procedures Coding and Reimbursement Q&A.

https://www.auanet.org/resources/biopsy-procedures.cfm.

Hospital ICD-10-CM 2017. American Medical Association, Chicago, IL 2016.

ICD-10-PCS 2017. American Medical Association, Chicago, IL 2016.

ICD-10-CM 2017. American Medical Association, Chicago, IL 2016.

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888-319-9691 | www.rezum.com

©2017 NxThera, Inc. All rights reserved. Rezūm is a registered trademark of NxThera, Inc.

Reimbursement Support952-454-5361

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