rezūm system reimbursement guide

Transcription

1 rezūm system reimbursement guide OCTOBER 2016 Reimbursement Support

2 table of contents OVERVIEW Benign Prostatic Hyperplasia (BPH) The Rezūm System Indications for Use CODING AND PAYMENT Diagnosis Coding Physician Coding and Payment Physician Billing in the Office Physician Billing in a Facility Setting Outpatient Hospital Coding & Payment Ambulatory Surgery Center (ASC) Coding & Payment Inpatient Hospital BENEFITS AND COVERAGE The Prior Authorization Process FREQUENTLY ASKED QUESTIONS SAMPLE PRIOR AUTHORIZATION REQUEST SAMPLE LETTER OF MEDICAL NECESSITY THE REZŪM SYSTEM BIBLIOGRAPY REFERENCES Disclaimer The 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. Reimbursement Support rezumreimb@jdlymon.com Page 2

3 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 30cm 3 80cm 3. The Rezūm System is also indicated for treatment of prostate with hyperplasia of the central zone and/or a median lobe. BEFORE TREATMENT AFTER Bladder Bladder Bladder Prostate Prostate Prostate Hyperplastic Tissue Hyperplastic Tissue Urethra Urethra Urethra 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. Reimbursement Support rezumreimb@jdlymon.com Page 3

4 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 (effective 10/0 1/15)* 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 N Overflow incontinence N Other specified urinary incontinence R35.0 Frequency of micturition Reimbursement Support rezumreimb@jdlymon.com Page 4

5 ICD-10-CM Dx Code (effective 10/0 1/15)* 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 American Medical Association, Chicago, IL Reimbursement Support Page 5

6 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 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 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. * American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. Reimbursement Support rezumreimb@jdlymon.com Page 6

7 PHYSICIAN BILLING IN THE OFFICE Codes for the radiofrequency thermotherapy ablation procedure to treat BPH and conscious sedation services are included below. CPT Code* Description 2016 Medicare National Average Individual Non-Facility RVUs Total Non- Facility RVUs Work: Transurethral destruction of prostate tissue; by radiofrequency thermotherapy $1,934 Non-Facility Practice Expense: Malpractice: Conscious Sedation Moderate sedation services (other than those services described by codes ) 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; age 5 years or older, first 30 minutes intra-service time Carrier priced by report N/A N/A Each additional 15 minutes intra-service time (list separately in addition to code for primary service) Carrier priced by report N/A N/A * Current Procedural Terminology 2016, American Medical Association. Chicago, IL CPT is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT ) is copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply. Refer to the AMA website for current information on the Medicare Fee Schedule for your specific area at: Medicare Physician Fee Schedule Final Rule, Federal Register (80 Fed Reg, No. 220) November 16, 2015, 42 CFR Parts 405, 410, 411, et al. American Urological Association: Prostate Procedures Coding and Reimbursement Q&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. These services may be reported using CPT codes 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. Reimbursement Support rezumreimb@jdlymon.com Page 7

8 PHYSICIAN BILLING IN A FACILITY SETTING Codes for the radiofrequency thermotherapy ablation procedure to treat BPH and conscious sedation are included below. CPT Code* Description 2016 Medicare National Average Individual Facility RVUs Total Facility RVUs Work: Transurethral destruction of prostate tissue; by radiofrequency thermotherapy $641 Facility Practice Expense: 5.82 Malpractice: Conscious Sedation Moderate sedation services (other than those services described by codes ) 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; age 5 years or older, first 30 minutes intra-service time Carrier priced by report N/A N/A Each additional 15 minutes intra-service time (list separately in addition to code for primary service) Carrier priced by report N/A N/A * Refer to the AMA website for current information on the Medicare Fee Schedule for your specific area at: Medicare Physician Fee Schedule Final Rule, Federal Register (80 Fed Reg, No. 220) November 16, 2015, 42 CFR Parts 405, 410, 411, et al. American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. 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 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. Reimbursement Support rezumreimb@jdlymon.com Page 8

9 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/ HCPCS Code Description APC 2016 Medicare National Average* Transurethral destruction of prostate tissue; by radiofrequency thermotherapy 5375 $3,394 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. CPT Code/ HCPCS Code Description 2016 Medicare National Average* Transurethral destruction of prostate tissue; by radiofrequency thermotherapy $1,499 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 hospitalization. Possible MS-DRGs for the Rezūm procedure are listed below. CPT Code/ HCPCS Code Description ICD-10-PCS Procedure Code (effective 10/1/15) Definition Other transurethral destruction of prostate tissue by other thermotherapy 0V507ZZ Destruction of prostate, via natural or artificial opening MS-DRG Description FY2016 Medicare National Average** 0713 Transurethral prostatectomy with CC/MCC $8, Transurethral prostatectomy without CC/MCC $4,766 * OPPS and ASC Final Rule, Federal Register (80 Fed Reg, No. 219) November 13, 2015, 42 CFR Parts 405, 410 and 412 et al. American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. ICD-10-PCS American Medical Association, Chicago, IL DRG Expert. Ingenix, St. Anthony Publishing/Medicode. Salt Lake City, **IPPS Final Rule, Federal Register (80 Fed Reg, No. 158) August 17, 2015, 42 CFR Part 412). Reimbursement Support rezumreimb@jdlymon.com Page 9

10 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. The treatment of BPH by radiofrequency thermotherapy is not new and is appropriately reported with CPT code A search of Medicare s Local Coverage Determinations (LCDs) and National Coverage Determinations (NCDs) show that the Medicare Administrative Contractors (MACs) are not managing the treatment of this disease by radiofrequency thermotherapy, and consider it to be medically necessary for patients diagnosed with BPH. 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 Included in this Reimbursement Guide are sample letters which may be used at different points during this process. STEP 1 STEP 2 STEP 3 PRIOR AUTHORIZATION REQUEST APPEALS PROCESS PROCEDURE Follow payer process to request prior authorization (or pre-determination) of CPT code Include: Patient history and medical necessity for the procedure CPT and diagnosis codes 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). Once authorization has been approved by the payer, you may proceed with the thermotherapy ablation procedure and billing the payer. STEP 1: Allow up to 30 days for the payer to process the request STEP 2: Allow an additional days for each level of appeal Up to four months may lapse before final approval Reimbursement Support rezumreimb@jdlymon.com Page 10

11 frequently asked questions 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 (Transurethral destruction of prostate tissue; by radiofrequency thermotherapy) should be used to report the transuretheral needle ablation procedure using the Rezūm System.* To report the Rezum procedure on medical claims, use CPT code 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. Q. DOES MEDICARE COVER CPT CODE 53852? A. Medicare Administrative Contractors (MACs) consider radiofrequency thermotherapy ablation reported using CPT code medically necessary for treating patients with BPH. Q. DO PRIVATE PAYERS COVER CPT CODE 53852? A. Most payers consider CPT code 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? the transurethral RF thermotherapy procedure to treat BPH, and is reported using CPT code 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 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 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. These services may be reported using CPT codes 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 Q. ARE OTHER PROCEDURES INCLUDED IN THE PAYMENT FOR CPT CODE 53852? A. CPT code 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. A. The Rezūm System is a technology used to perform * American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. Current Procedural Terminology 2016, American Medical Association. Chicago, IL CPT is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT ) is copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply. Reimbursement Support rezumreimb@jdlymon.com Page 11

12 SAMPLE PRIOR AUTHORIZATION REQUEST CPT 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 procedure that uses thermal energy created with radiofrequency power to treat obstructive prostate tissue by delivering targeted, 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: (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] Reimbursement Support rezumreimb@jdlymon.com Page 12

13 SAMPLE LETTER OF MEDICAL NECESSITY CPT 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: (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 weeks 1. 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): doi: /j.juro Reimbursement Support rezumreimb@jdlymon.com Page 13

14 the rezūm system bibliography MANUSCRIPTS 1. 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. Erectile and Ejaculatory Function Preserved with Convective Water Vapor Energy Treatment of LUTS Secondary to BPH: Randomized Controlled Study. J Sex Med 2016;13: 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: 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: 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: 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: 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: 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: Ebbing J, Bachmann A. Anesthesia-free procedures for benign prostate obstruction: worth it? Curr Opin Urol 2015;25: 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 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 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 # Plenary II Late-Breaking Abstract Session. American Urological Association Annual Meeting 2015, New Orleans, Louisiana. Reimbursement Support rezumreimb@jdlymon.com Page 14

15 4. Mynderse L, Hanson D, Robb R, Rijo Cedano E, Pacik D, Vit V, Varga G, Larson T, Dixon C. Rezūm System Water 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 MP 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 MP 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 Reimbursement Support rezumreimb@jdlymon.com Page 15

16 references Current Procedural Terminology 2016, American Medical Association. Chicago, IL CPT is a registered trademark of the American Medical Association. Current Procedural Terminology (CPT ) is copyright 2015 American Medical Association. All Rights Reserved. Applicable FARS/DFARS apply. Medicare Physician Fee Schedule Final Rule, Federal Register (80 Fed Reg, No. 220) November 16, 2015, 42 CFR Parts 405, 410, 411, et al. OPPS and ASC Final Rule, Federal Register (80 Fed Reg, No. 219) November 13, 2015, 42 CFR Parts 405, 410 and 412 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 (80 Fed Reg, No. 158) August 17, 2015, 42 CFR Part 412. American Urological Association: Prostate Procedures Coding and Reimbursement Q&A. Hospital ICD-10-CM American Medical Association, Chicago, IL ICD-10-PCS American Medical Association, Chicago, IL ICD-10-CM American Medical Association, Chicago, IL Reimbursement Support rezumreimb@jdlymon.com Page 16

17 Reimbursement Support NxThera, Inc. All rights reserved. Rezūm is a registered trademark of NxThera, Inc.