INTRODUCTION TO STARTING MYOSURE IN-OFFICE PROCEDURES

The MyoSure® System Startup Guide

PRODUCT INFORMATION

MyoSure® LITE Device

REIMBURSEMENT Reimbursement Rates

Reimbursement Guide

Reimbursement Support

PROCEDURE

Supplies & Equipment• Inventory Checklist

Maintenance & Sterilization• Instrument Tray

• Hysteroscope Reprocessing

Anesthesia & Pain Management

• Overview of Options

IN-OFFICE & PATIENT SUPPORT

Available Services

RESOURCES

Clinical Summaries

Additional Resources

Overview

PRODUCT INFORMATION

PRODUCT INFORMATION

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.

About the MyoSure® LITE device

VISUALIZE the uterine cavity throughout

the entire procedure

COMPLETE the procedure efficiently in

one simple step

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

IndicationsThe 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.

Offer patients the in-office benefits of the MyoSure LITE device.

REIMBURSEMENT

REIMBURSEMENT RATES

What does this mean for your practice?YEAR

Facility (Professional) Office/Freestanding (Global)

RVU Rate RVU Rate

2016 7.56 $270.68 11.44 $409.60

2017 6.72 $241.17 38.51 $1,382

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.*

CPT code 58558Hysteroscopy, surgical; with sampling (biopsy) of endometrium and/or polypectomy, with or without D&C

in reimbursement rate for in-office hysteroscopic biopsy and polypectomy

If your practice has a contract based on a:

Percentage of MedicareYou may potentially receive higher reimbursement for CPT code 58558 in-office

Negotiated fee scheduleYou 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

237% INCREASE

Announcing improved reimbursement rate for polypectomy procedures in the office setting

*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

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.

2. Current contractual agreements:a. What is the current fee schedule

based upon?

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

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?

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)

BCBS 15

United 9

Aetna 13

Cigna 32

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

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

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.

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.

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

g. Labor

h. Professional reimbursement

2. Capital costs: Determine cost of capital equipment.

a. MyoSure control unit w/foot pedal

b. MyoSure operative hysteroscope

c. Hysteroscopic fluid pump

d. Regulated vacuum source and tubing

e. Collection canisters (reusable)

f. Camera, light source, video monitor

Calculating Expenses

REIMBURSEMENT SUPPORT

Tel: (866) 369-9290

Email: Hologic@thepinnaclehealthgroup.com

Available: Mon - Fri 8:30 am - 6:00 pm EST

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

• INSURANCE COVERAGE

• MANAGED CARE CONTRACTED RATE VERIFICATION

• PATIENT BENEFIT VERIFICATION

• PATIENT PRE-AUTHORIZATION/PRE-CERTIFICATION

• CLAIMS APPEALS & DENIALS

• LOW CLAIMS PAYMENT

• HIPAA COMPLIANCE SUPPORT

Contact Pinnacle Health Group

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 ❑ Contracts with insurance companies

❑ Processes for reimbursement

❑ Office procedure management

❑ Personnel training to manage emergencies

SAFETY EQUIPMENT ❑ Blood pressure and pulse monitor

❑ Oxygen with end tidal carbon dioxide monitor

❑ Pulse oximeter

❑ Source of oxygen

❑ Source of suction

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

ANESTHESIAIt 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.

SUPPLIES ❑ MyoSure instrument tray

❑ MyoSure controller

❑ MyoSure device

❑ Hysteroscope

❑ Aquilex fluid management system

❑ ≥ 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:

• 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

DESCRIPTION PART NUMBER

MyoSure Rod Lens Hysteroscope Instrument Tray 40-903

Custom posts and graphics for simplified disassembly of hysteroscope, outflow channel, and accessories

For complete sterilization parameters, please consult the MyoSure Cleaning and Reprocessing Instructions

Clear lid for easy identification of components

Locking lid for ease in transporting, handling, and storingLightweight tray for

easy transportation

MyoSure Instrument Tray Ordering Information

To place an order, contact Hologic Customer Service at (800) 442-9892

MAINTENANCE & STERILIZATION: HYSTEROSCOPE REPROCESSING

GENERAL CLEANING Proper cleaning should be performed prior to sterilization

Disassembly:• Remove light post adapters

• Remove single-use seals from hysteroscope and outflow channel

• Open stopcocks on hysteroscope and removable outflow channel

Cleaning:• Scrub all crevices using a cleaning brush to

remove any visible debris (do not scratch any optical surface)

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

Soaking and Rinsing:• Soak hysteroscope and accessories in

an enzymatic, neutral pH cleaner for 5 minutes

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

STERILIZATIONSterilization of hysteroscope and outflow channel is achieved with the following validated systems:

Steam Autoclave Wrapped

Follow standard hospital procedures:

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

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

Ethylene Oxide (100% EtO – wrapped) Follow standard hospital procedure maintaining the following parameters:

• Temperature: 131° ±5°F (55°C)

• Relative Humidity: 35-70%

• Gas Concentration: ~736 mg/l

• Exposure Time: 60 minutes

• Aeration Time: 11 hours

Sterrad®

• 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.

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:

Deposits may develop on the three optical surfaces:

• The distal tip

• The proximal window or eyepiece

• The fiber optic light post

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

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.

Check surfaces with an 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.

2

3

4

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

1

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

ANESTHESIA & PAIN MANAGEMENT: OVERVIEW OF OPTIONS

1. PARA/INTRACERVICAL BLOCK• Effective in a randomized, comparative trial

• Well-tolerated by patients: low pain scores reported

• 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

2. INTRACERVICAL BLOCK • Effective in a randomized, comparative trial

• Well-tolerated by patients: low pain scores reported

• 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

3. MOBILE ANESTHESIA • Consult your local mobile anesthesia group

(available in certain markets)

Overview of Options for In-office Procedures

IN-OFFICE & PATIENT SUPPORT

AVAILABLE SERVICES

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

Accredited educational offerings including e-learning, peer-to-peer education,

and hands-on training

Expert sales representatives and clinical specialists

Education and Training

Customer Support Product Support Patient Advocacy

Patient Outreach Reimbursement Support

Online portal featuring patient education and customizable outreach material

Unlimited telephone support and expedited replacements to avoid costly downtime

Coding guides with Medicare national average reimbursement, payer tools,

and a reimbursement hotline

Hologic raises awareness about women’s health through consumer sites, blogs,

and partnerships with non-profits

Visit: Hologic.com/training

Call: 800-442-9892 Call: 800-442-9892 Visit: ChangeTheCycle.com

Visit: GYNMarketing.com Call: 866-369-9290

RESOURCES

RESOURCES: CLINICAL SUMMARIES ON PAIN MANAGEMENT & PROVEN OUTCOMES

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”

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

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

ObjectiveGauge 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 SCHEIBER MD, ET AL

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: Rubinoobgyn@yahoo.com

AbstractStudy 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.

MyoSure® Tissue Removal System Efficacy - one year follow-up

Twelve Month Outcomes for Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas in an Office or Ambulatory Surgical Center

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 womenshealth@hologic.com.

Title“Twelve Month Outcomes for Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas in an Office or Ambulatory Surgical Center”

ObjectiveExamine efficacy of hysteroscopic removal of polyps and myomas on health-related quality of life and symptom severity at 1-year post-procedure.

This study was funded by Hologic Inc.

Michael D. Scheiber, MD, MPH, Serena H. Chen, MDScheiber 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 ef� cacy of hysteroscopic morcellation of intrauterine polyps and myomas in a diverse set of clinical facilities.

Clinical Summary:

A Prospective Multi-center Registry of Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas

Journal of Gynecologic Surgery

MYOSURE: PATHOLOGY REMOVAL

Methods

All procedures were performed using the MyoSure hysteroscopic tissue removal system

Inclusion criteria: - Women between 18 and 65 years of age - Identi� cation of intrauterine pathology via

ultrasound, SIS, hysteroscopic examination - Polyps of any size - Submucosal myomas ≤6 cm of� ce 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 de� cit - Mechanical cervical dilation (if needed)

Study Type: Prospective, multi-center registry

Number of Patients: 278

Treatment Setting: - 250 treated in Ambulatory surgery setting

(ASC)- 28 treated in gynecology of� ce 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 in� ammatory disease - Pelvis or vaginal infection - Known or suspected coagulopathy - Bleeding disorder - History of disease increasing � uid overload risk

Study completed in 36 obstetrics and gynecology practices and hospitals in the United States

Title“Clinical Summary: A Prospective Multi-center Registry of Patients Undergoing Hysteroscopic Morcellation of Uterine Polyps and Myomas”

ObjectiveInvestigate the safety and efficacy of hysteroscopic morcellation of intrauterine polyps and myomas in a diverse set of clinical facilities.

Please contact your sales representative to obtain copies of the following resources:

RESOURCES: ADDITIONAL 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.

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

TREATMENT OPTIONS FOR ABNORMAL UTERINE BLEEDING (AUB) 2017 CODING GUIDE

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

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

SOCIAL MEDIA KIT

OB/GYN Patient OutreachSocial Media Kit

SET UP GUIDE

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

Please contact your sales representative to obtain copies of the following resources:

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.

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.