MyoSure LITE Device System Startup Guide

Overview PRODUCT INFORMATION

PROCEDURE

MyoSure® LITE Device

Supplies & Equipment

IN-OFFICE & PATIENT SUPPORT

• Inventory Checklist

Available Services

Maintenance & Sterilization

RESOURCES

REIMBURSEMENT Reimbursement Rates Reimbursement Guide Reimbursement Support

• Instrument Tray • Hysteroscope Reprocessing

Anesthesia & Pain Management • Overview of Options

Clinical Summaries Additional Resources

PRODUCT INFORMATION

PRODUCT INFORMATION

About the MyoSure® LITE device In-office procedures just got enLITEned. Remove small polyps up to 3 cm and also use the resected tissue for histologic assessment. With the 6 mm diameter of the MyoSure hysteroscope, only 6 mm cervical dilation is required during a MyoSure LITE procedure.

VISUALIZE

COMPLETE

TRUST

the uterine cavity throughout the entire procedure

the procedure efficiently in one simple step

that the quality and quantity of your collection will allow for histologic assessment

Offer patients the in-office benefits of the MyoSure LITE device. Indications The MyoSure® tissue removal system is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue such as: submucous myomas, endometrial polyps, and retained products of conception.

Contraindications The MyoSure® tissue removal system should not be used with patients who are or may be pregnant, or are exhibiting pelvic infection, cervical malignancies, or previously diagnosed endometrial cancer.

REIMBURSEMENT

REIMBURSEMENT RATES

Announcing improved reimbursement rate for polypectomy procedures in the office setting

237 INCREASE %

On January 1, 2017, the Medicare Physician Fee Schedule increased the relative value unit (RVU) for in-office hysteroscopy with biopsy/ polypectomy (CPT code 58558). Based on the 2017 RVU and 2017 Medicare conversion factor, the average Medicare payment rate increased from $410 to $1,382.*

What does this mean for your practice?

in reimbursement rate for in-office hysteroscopic biopsy and polypectomy CPT code 58558 Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy, with or without D&C Facility (Professional)

Office/Freestanding (Global)

YEAR

If your practice has a contract based on a:

RVU

Rate

RVU

Rate

2016

7.56

$270.68

11.44

$409.60

2017

6.72

$241.17

38.51

$1,382

Percentage of Medicare

You may potentially receive higher reimbursement for CPT code 58558 in-office

Negotiated fee schedule

You will not automatically receive an increase in reimbursement, but you may have the opportunity to renegotiate your rate when your contract is up for renewal or during your contract period

*The 2016 and 2017 physician RVUs are from the 2016 and 2017 RVU files available on the Center for Medicare and Medicaid Services website at www.cms.gov. The information contained on this page is provided for informational purposes only and represents no guarantee by Hologic concerning levels of reimbursement or payment. While we have made an effort to provide information that is current, the information may not be as current or comprehensive when you view it. We recommend that you consult your reimbursement advisor or payor organization with regard to reimbursement policies. Providers are responsible for determining insurance coverage, as well as, determining the appropriate billing and coding submissions.

REIMBURSEMENT GUIDE 

As you know, there is a CPT code for a polyp removal procedure (58558) that includes procedures performed with the MyoSure® device (system). There are offices throughout the country that have been successful with a carve-out for this procedure with commercial payers.

Below are a few things your office can do to gain a better understanding of how to approach payers through our reimbursement hotline. 1. PPR form: Fill out Private Payer Research form and fax to Pinnacle with top 5 payers. a. Make sure to request that Pinnacle looks up physician reimbursement in both the office and hospital for the following CPT code: 58558.

3. Data collection: How many polypectomies and myomectomies have been performed with MyoSure in the last 12 months? a. Data should be listed by payer, for example:

58558 (polyp)

2. Current contractual agreements:

4. EOB collection: EOBs from the cases should be collected. 5. Complete packet of information for payer with collected data. a. Physician request letter, including clinical data b. Practice Administrator/Office Manager request, including economic data and cost effectiveness research

Calculating Expenses 1. Supply costs: Determine actual cost per procedure. a. Device cost b. Hysteroscopic disposable seal sets c. Sterile supplies (kit) d. Tubing (inflow and outflow) e. Saline (3 L bag) f. Collection canisters and tissue trap

a. What is the current fee schedule based upon?

BCBS

15

i. Percentage of Medicare fee schedule? If so, which year?

United

9

2. Capital costs: Determine cost of capital equipment.

Aetna

13

a. MyoSure control unit w/foot pedal

Cigna

32

ii. Percentage of billed charges? If so, what is the maximum allowable rate? b. When does the current fee schedule expire? c. When is the contract typically updated/renegotiated with insurance providers?

g. Labor h. Professional reimbursement

b. MyoSure operative hysteroscope

*Sample numbers are reflected in the chart above for a 12-month volume by payer, by CPT code.

c. Hysteroscopic fluid pump d. Regulated vacuum source and tubing e. Collection canisters (reusable) f. Camera, light source, video monitor

The information contained on this page is provided for informational purposes only and represents no guarantee by Hologic concerning levels of reimbursement or payment. While we have made an effort to provide information that is current, the information may not be as current or comprehensive when you view it. We recommend that you consult your reimbursement advisor or payor organization with regard to reimbursement policies. Providers are responsible for determining insurance coverage, as well as, determining the appropriate billing and coding submissions.

REIMBURSEMENT SUPPORT  In partnership with the Pinnacle Health Group staff, Hologic provides reimbursement and coding support for our partner providers. The Pinnacle Health Group staff of professional certified coders addresses questions regarding:

• CODING

Contact Pinnacle Health Group Tel: (866) 369-9290 Email: [email protected] Available: Mon - Fri 8:30 am - 6:00 pm EST

• INSURANCE COVERAGE • MANAGED CARE CONTRACTED RATE VERIFICATION • PATIENT BENEFIT VERIFICATION • PATIENT PRE-AUTHORIZATION/PRE-CERTIFICATION • CLAIMS APPEALS & DENIALS • LOW CLAIMS PAYMENT • HIPAA COMPLIANCE SUPPORT The information contained on this page is provided for informational purposes only and represents no guarantee by Hologic concerning levels of reimbursement or payment. While we have made an effort to provide information that is current, the information may not be as current or comprehensive when you view it. We recommend that you consult your reimbursement advisor or payor organization with regard to reimbursement policies. Providers are responsible for determining insurance coverage, as well as, determining the appropriate billing and coding submissions.

PROCEDURE

SUPPLIES & EQUIPMENT: INVENTORY CHECKLIST TO GET YOU STARTED IN-OFFICE PROCEDURE DUE DILIGENCE

ANESTHESIA

❑❑ Contracts with insurance companies

❑❑ Personnel training to manage emergencies

It is important to review the applicable federal, state, and local laws for outpatient surgery to ensure that you are safely and effectively setting up your office. These guidelines vary from state to state, so you should consult with your local and state medical regulatory boards that govern office-based procedures to learn which regulations apply to your practice.

SAFETY EQUIPMENT

SUPPLIES

❑❑ Blood pressure and pulse monitor

❑❑ MyoSure instrument tray

❑❑ Oxygen with end tidal carbon dioxide monitor

❑❑ MyoSure controller

❑❑ Pulse oximeter

❑❑ MyoSure device

❑❑ Source of oxygen

❑❑ Hysteroscope

❑❑ Source of suction

❑❑ Aquilex fluid management system

❑❑ Processes for reimbursement ❑❑ Office procedure management

PROTOCOLS ❑❑ Controlled substances storage and administration ❑❑ Testing and inspection of equipment ❑❑ Treatment of emergencies such as cardiopulmonary events or malignant hyperthermia ❑❑ Emergency transport and admission to a predetermined acute care facility

❑❑ ≥ 1000 mL bag of saline ❑❑ Pole to hang the bag ❑❑ Cysto tubing ❑❑ Buttocks drape ❑❑ Enzymatic cleaner for the scope after the procedure ❑❑ 20 cc syringe to clean scope ❑❑ Cidex (high-level disinfectant) OPA (gallon jug) to soak (or state required in-office policies) ❑❑ Endoscope tray to soak or autoclave

List not exhaustive, each account must determine the necessary supplies, protocols, and equipment based on the requirements of their jurisdiction and individual needs of their practice and patients.

MAINTENANCE & STERILIZATION: INSTRUMENT TRAY 

The solution to properly store and reprocess the MyoSure® Rod Lens Hysteroscope. Compatible with the following sterilization systems:

Clear lid for easy identification of components

• Steam pre-vacuum sterilization (pre-vacuum autoclave): 270˚F (132˚C) for 4 minutes • Steam gravity displacement sterilization (gravity autoclave): 270˚F (132˚C) for 15 minutes • STERRAD® 100STM system Lightweight tray for easy transportation

Locking lid for ease in transporting, handling, and storing Custom posts and graphics for simplified disassembly of hysteroscope, outflow channel, and accessories

MyoSure Instrument Tray Ordering Information DESCRIPTION MyoSure Rod Lens Hysteroscope Instrument Tray

To place an order, contact Hologic Customer Service at (800) 442-9892 For complete sterilization parameters, please consult the MyoSure Cleaning and Reprocessing Instructions

PART NUMBER 40-903

MAINTENANCE & STERILIZATION: HYSTEROSCOPE REPROCESSING 

GENERAL CLEANING

Proper cleaning should be performed prior to sterilization

Disassembly:

Cleaning:

Soaking and Rinsing:

• Remove light post adapters

• Scrub all crevices using a cleaning brush to remove any visible debris (do not scratch any optical surface)

• Soak hysteroscope and accessories in an enzymatic, neutral pH cleaner for 5 minutes

• Scrub each lumen and flush with an enzymatic, neutral pH cleaner a minimum of 3 times to ensure no air remains within the lumen

• Thoroughly rinse the scope and accessory components to completely remove the cleaning solution

• Remove single-use seals from hysteroscope and outflow channel • Open stopcocks on hysteroscope and removable outflow channel

STERILIZATION

Sterilization of hysteroscope and outflow channel is achieved with the following validated systems: Ethylene Oxide (100% EtO – wrapped)

Sterrad®

Steam Autoclave Wrapped

Follow standard hospital procedure maintaining the following parameters:

• Devices meet guidelines for Sterrad 100S, NX, and 100NX systems and require the use of a Sterrad-compatible tray or container system. Refer to manufacturer’s Instructions for Use for more information.

Follow standard hospital procedures:

• Temperature: 131° ±5°F (55°C) • Relative Humidity: 35-70% • Gas Concentration: ~736 mg/l • Exposure Time: 60 minutes • Aeration Time: 11 hours

• Pre-vacuum method: 270-275°F (132-135°C) for 3 minutes • Gravity method: 270-275°F (132-135°C) for 15 minutes

MAINTENANCE & STERILIZATION: HYSTEROSCOPE REPROCESSING 

MAINTENANCE • Always check the distal and proximal lenses of the hysteroscope for cracked or scratched lenses • Check the surface cleanliness of the distal and proximal lenses −− A foggy or cloudy image can be the result of moisture entering the optical system or lack of cleanliness of exterior surfaces

Please refer to the following steps to ensure scope is producing the best possible image:

Polishing of distal tip, eyepiece, and fiber optic light post: 1

Dab some polishing paste onto a clean cotton swab and apply to optical surface in a light circular motion.

2

Take a clean cotton swab and use a little more force to clean any deposits on the optical surface.

3

When surface is clean, take another cotton swab and remove any leftover polishing paste. If you have acetone or alcohol, use to clean off any extra polishing paste.

4

 heck surfaces with an C eye loupe to see if all deposits are removed and/or look through the scope to confirm clear image.

Polishing of Optical Surfaces Polishing should only be performed when the image, as viewed through the scope, is cloudy and not as part of your routine cleaning procedures.

Deposits may develop on the three optical surfaces: • The distal tip • The proximal window or eyepiece • The fiber optic light post

ANESTHESIA & PAIN MANAGEMENT: OVERVIEW OF OPTIONS

Overview of Options for In-office Procedures 1. PARA/INTRACERVICAL BLOCK

2. INTRACERVICAL BLOCK

• Effective in a randomized, comparative trial

• Effective in a randomized, comparative trial

• Well-tolerated by patients: low pain scores reported

• Well-tolerated by patients: low pain scores reported

• For example of pain management, please request the following clinical summary in the Resources section

• For example of pain management, please request the following clinical summary in the Resources section

−− “Randomized Comparative Trial of Cervical Block Protocols for Pain Management During Hysteroscopic Removal of Polyps and Myomas” by Lukes A, et al

−− “Randomized Comparative Trial of Cervical Block Protocols for Pain Management During Hysteroscopic Removal of Polyps and Myomas” by Lukes A, et al

3. MOBILE ANESTHESIA • Consult your local mobile anesthesia group (available in certain markets)

IN-OFFICE & PATIENT SUPPORT

AVAILABLE SERVICES 

Support services available from Hologic Take advantage of these training, support, and outreach programs from the makers of the NovaSure® and MyoSure® systems to help you succeed.

Education and Training

Patient Outreach

Reimbursement Support

Accredited educational offerings including e-learning, peer-to-peer education, and hands-on training

Online portal featuring patient education and customizable outreach material

Coding guides with Medicare national average reimbursement, payer tools, and a reimbursement hotline

Visit: Hologic.com/training

Visit: GYNMarketing.com

Call: 866-369-9290

Customer Support

Product Support

Patient Advocacy

Expert sales representatives and clinical specialists

Unlimited telephone support and expedited replacements to avoid costly downtime

Hologic raises awareness about women’s health through consumer sites, blogs, and partnerships with non-profits

Call: 800-442-9892

Call: 800-442-9892

Visit: ChangeTheCycle.com

RESOURCES

RESOURCES: CLINICAL SUMMARIES ON PAIN MANAGEMENT & PROVEN OUTCOMES

Please contact your sales representative to obtain copies of the following resources: MCLLWAINE P, ET AL

LUKES A, ET AL Title “A Prospective Study of the Use of the MyoSure Resectoscope to Manage Endometrial Polyps in an Outpatient Setting”

Title “Randomized Comparative Trial of Cervical Block Protocols for Pain Management During Hysteroscopic Removal of Polyps and Myomas”

Objective Compare patient satisfaction and pain scores of pre- and postmenopausal women undergoing outpatient removal of endometrial polyps using the MyoSure resectoscope (in use since 2009).

Objective Gauge the effectiveness of two cervical block protocols for pain management during the MyoSure procedure for the hysteroscopic removal of polyps and myomas.

RUBINO RJ, ET AL MyoSure Tissue Removal System Efficacy - one year follow-up

SCHEIBER MD, ET AL

®

Twelve Month Outcomes for Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas in an Office or Ambulatory Surgical Center Robert J. Rubino, MD, Andrea S. Lukes, MD The Rubino OBGYN Group (Dr. Rubino), Carolina Women’s Research and Wellness Center (Dr. Lukes) Corresponding author contact information: Robert Rubino, MD 101 Old Short Hills Road, Suite 101, West Orange, NJ 07901 Email: [email protected]

Abstract Study Objective: To examine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year post-procedure.

Design: Randomized, prospective, comparative setting clinical trial. (Canadian Task Force classification II-2) Setting: Nine outpatient obstetrics and gynecology practices and hospitals in the U.S. Patients: Women 18 to 55 years of age with polyps and/or Type 0 or I myomas ≥1.5 cm and ≤3.0 cm. Interventions: Treatment of polyps and fibroids with the MyoSure device. Measurements and Main Results: A total of 118 lesions (76 polyps, 42 myomas) were removed. Among the 118

pathologies removed, 53 were removed in an office setting (28 myomas, 25 polyps) and 55 were removed in an ambulatory surgical center (ASC) setting (14 myomas, 41 polyps). The mean percentage of pathology removed was 95.9 +/- 6.8% for fibroids and 99.9 +/- 0.7% for polyps. Symptom severity as measured by the UFS-QOL scale improved significantly (p<.01) between baseline (mean score of 67.5 +/- 15.4) and 12 months postprocedure (mean score of 22.3 +/- 22.6). Health related quality of life as measured by the HRQOL scale also improved significantly (p<.01) between baseline (mean score 38.7 +/23.3) and 12 months post-procedure (mean score of score 83.9 +/-24.4). Both the office and ASC groups demonstrated a statistically significant (p<.01) improvement in UFS-QOL and HRQOL. Conclusion: For women with intrauterine polyps and/or myomas who suffered from abnormal uterine bleeding, hysteroscopic morcellation with the MyoSure device provided significant, durable health related quality of life improvements up to 12 months post-procedure. These findings held for patients treated in both office-based setting and ambulatory surgical centers.

Safety • No bleeding adverse events • Low fluid deficit (mean fluid deficit of 461.0 cc)

Effectiveness • 99.9% of polyps and 95.9% of fibroids removed

Satisfaction • 89.2% patient satisfaction • Significant UFS-QOL reduction and improvement in HRQOL • 95.9% of patients would consider similar treatment again • 100% of patients would recommend similar treatment

MISC-03132-001 Rev. 001 ©2014 Hologic, Inc. All rights reserved. Printed in USA. Specifications are subject to change without prior notice. Hologic, Inc., MyoSure and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries, in the United States and/or other countries. All other trademarks and registered trademarks are the property of their respective owners. This information is intended for medical professionals in the U.S. and other markets and is not intended as a product solicitation or promotion where such activities are prohibited. Because Hologic materials are distributed through websites, eBroadcasts and tradeshows, it is not always possible to control where such materials appear. For specific information on what products are available for sale in a particular country, please contact your local Hologicrepresentative or write to [email protected].

Title “Twelve Month Outcomes for Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas in an Office or Ambulatory Surgical Center” Objective Examine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year post-procedure.

Journal of Gynecologic Surgery

Clinical Summary: A Prospective Multi-center Registry of Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas Michael D. Scheiber, MD, MPH, Serena H. Chen, MD Scheiber Michael D. and Chen Serena H. Journal of Gynecologic Surgery. April 2016, ahead of print. doi:10.1089/gyn.2016.0008.

Objective: To investigate the safety and efficacy of hysteroscopic morcellation of intrauterine polyps and myomas in a diverse set of clinical facilities.

Methods Study completed in 36 obstetrics and gynecology practices and hospitals in the United States Study Type: Prospective, multi-center registry Number of Patients: 278 Treatment Setting: - 250 treated in Ambulatory surgery setting (ASC) - 28 treated in gynecology office setting Exclusion criteria: - Pregnancy - IUD at time of procedure (if IUD was removed prior to procedure subjects were eligible) - Current usage of anticoagulant or antiplatelet medication - Active pelvic inflammatory disease - Pelvis or vaginal infection - Known or suspected coagulopathy - Bleeding disorder - History of disease increasing fluid overload risk

This study was funded by Hologic Inc.

MYOSURE: PATHOLOGY REMOVAL

Inclusion criteria: - Women between 18 and 65 years of age - Identification of intrauterine pathology via ultrasound, SIS, hysteroscopic examination - Polyps of any size - Submucosal myomas ≤6 cm office setting Surgical Data: - Age, weight, BMI, menopausal status - Size, number, and location of pathologies were recorded - Primary reason for treatment - Total procedure time - Total cutting time - Fluid deficit - Mechanical cervical dilation (if needed) All procedures were performed using the MyoSure hysteroscopic tissue removal system

Title “Clinical Summary: A Prospective Multi-center Registry of Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas” Objective Investigate the safety and efficacy of hysteroscopic morcellation of intrauterine polyps and myomas in a diverse set of clinical facilities.

RESOURCES: ADDITIONAL RESOURCES

Please contact your sales representative to obtain copies of the following resources: MYOSURE® SYSTEM SETUP GUIDE

AQUILEX® FLUID CONTROL SYSTEM SETUP & TROUBLESHOOTING GUIDE

Simplifies the setup process with easy-to-follow instructions for everything from inventory to implementation.

TREATMENT OPTIONS FOR ABNORMAL UTERINE BLEEDING (AUB)

Outlines and describes the available AUB treatments, as well as efficacy rates, advantages, and disadvantages.

SOCIAL MEDIA KIT

OB/GYN Patient Outreach Social Media Kit

SET UP GUIDE

Share non-branded, patientfocused marketing content on your practice’s social media channels.

Provides comprehensive support for Aquilex setup, settings, user tips, error codes, configuration images, and troubleshooting.

2017 CODING GUIDE

Reference the gynecologic procedures coding guide to access 2017 Medicare RVUs and rates.

Important Safety Information The MyoSure® tissue removal system is intended for hysteroscopic intrauterine procedures by trained gynecologists to resect and remove tissue including submucous myomas, endometrial polyps, and retained products of conception. It is not appropriate for patients who are or may be pregnant, or are exhibiting pelvic infection, cervical malignancies, or previously diagnosed endometrial cancer.

MISC-04410-001 ©2017 Hologic, Inc. Hologic, Aquilex, MyoSure, NovaSure, The Science of Sure, and associated logos are trademarks or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners.