Cardionet 1006, 1007 physicians instruction manual

CONTENTS

Contact Information ................................................................................ 2

Introduction ............................................................................................. 3

Product Description ................................................................................. 4

Service Overview ..................................................................................... 6

Patient Enrollment ................................................................................... 8

Electronic Patient Enrollment ................................................................ 10

Indications and Contraindications.......................................................... 11

Reports .................................................................................................. 12

Physician Notification ............................................................................ 14

Billing ..................................................................................................... 15

Cautions and Warnings .......................................................................... 17

Technical Specifications ......................................................................... 19

Sample Forms and Reports ................................................................... 28

DRAFT

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CONTACT INFORMATION

Main Number [phone]

[phone]

Patient Service Center [phone] Physician Notification

[phone] Patient Inquiries

Enrollment [phone] Fax

Billing [phone]

Caution: Federal law restricts this device
to sale by or on the order of a physician.

Copyright 2004

All rights reserved

Lit Number - 100327

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Revision E

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February 2004

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2

INTRODUCTION

CardioNet: Mobile Cardiac Outpatient Telemetry

CardioNet has developed a new, integrated technology and
service – Mobile Cardiac Outpatient Telemetry – which allows
heartbeat-by-heartbeat, ECG monitoring, analysis and response,
at home or away, 24/7/365.

CardioNet’s Mobile Cardiac Outpatient Telemetry assists physicians in
the diagnosis and management of difficult-to-diagnose arrhythmias.
Given the infrequent and asymptomatic nature of some arrhythmias, it
is often challenging to capture an actual arrhythmia with conventional
monitoring technology, such as Holter and cardiac event monitoring.

With the CardioNet System, we are able to automatically detect and
capture asymptomatic and symptomatic arrhythmias, based on
monitoring parameters defined by the prescribing physician. In
addition, the patient can utilize the touch screen on the CardioNet

monitor to enter
their symptoms and activity level at the time
of a documented event. The physician then
receives a representative ECG strip of the
event; a time and date stamp of the actual
event, including symptoms and activity, and is
therefore able to make a more informed and

accurate diagnosis.

Patient Monitored
24/7/365

Physician Receives
CardioNet Report

CardioNet outpatient
telemetry offers
physicians a powerful
new diagnostic and
patient management
tool for a wide range of
monitoring indications.

Patient Enters Symptoms
and Activities

3

PRODUCT DESCRIPTION

CardioNet merges patient monitoring, wireless communications,
and the Internet to allow targeted cardiac rhythm related problems
to be identified, quantified, and communicated to the prescribing
physician in a timely and efficient manner.

The CardioNet System is comprised of a sensor, monitor, and base.
The lightweight sensor is worn by the patient on a lanyard or belt
clip, it continuously records two channels of ECG, and transmits the
ECG by a radio frequency (RF) link to the monitor. The sensor is
powered by a disposable alkaline battery, which typically lasts 24-36
hours. While using the sensor, the patient is required to wear (3)
disposable electrodes to record their ECG.

The monitor is approximately the size of a PDA device. It has a
powerful microprocessor, extensive memory, imbedded algorithm,
LCD display, wireless modem, and a global positioning system
(GPS). The monitor is powered by a rechargeable lithium battery,
which typically lasts 18 hours.

The monitor’s microprocessor is programmed to identify cardiac
rhythm problems within guidelines established by the prescribing
physician. The algorithm detection parameters and physician
notification criteria are individualized for each patient and physician.

Sensor with Lead Wires

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CardioNet Monitor in Base

The monitor continuously analyzes the ECG in real time as it is
transmitted from the sensor. When an abnormal rhythm has been
identified based on the monitoring parameters, the data is automatically
sent via a wireless modem to the CardioNet Patient Service Center for
additional review and interpretation by a certified monitoring specialist.

In the case of a patient-initiated event, the monitor automatically
prompts the patient to enter their symptoms and activities from a
predetermined list on the touch screen display.

When the patient is at home and an event occurs while the monitor is in
the base, the patient’s normal telephone line is used to transmit the
data. If an event occurs when the patient is in an area where cellular
coverage is inadequate, the patient may elect to transmit their ECG
directly, using a regular telephone.

The base utilizes an AC power supply and is connected to the patient’s
telephone line. The base also consists of two antennas, which allows the
patient to have an expanded RF range within their home. When the
patient is mobile, the RF range or leash length between the monitor and
sensor is estimated to be 25-50 feet. The sensor and monitor are
designed to alert the patient if and when they are out of RF range or
cellular coverage.

The CardioNet monitor has sufficient memory to store a minimum of
twenty-four hours of the patient’s ECG. A daily protocol exists to upload
the patient’s 24-hour ECG data, including related events and trends from
the monitor to the Patient Service Center.

5

SERVICE OVERVIEW

First, the prescribing physician is registered in the CardioNet service. All
applicable contact and demographic data is collected and inputted into
the CardioNet Patient Enrollment and Management System (PEMS) by a
CardioNet representative. When a physician identifies a patient who is
appropriate for CardioNet services, a patient enrollment is initiated by
his/her office, included is patient demographics, insurance information,
indications for usage, duration, thresholds, and medical necessity where
applicable. Upon completion, the enrollment form is submitted to the
Patient Service Center – either by fax or Internet.

For non Medicare patients, the physician practice may utilize the CPT
code 93799-26 when billing for the professional interpretation,
including the narrative description “ECG arrhythmia detection and alarm
system.” An individual payor may establish or recommend alternative
codes to be used to reflect the professional interpretation for CardioNet
related services. The physician practice may wish to contact their
provider representative to establish the appropriate billing requirements
for CardioNet.

CardioNet provides a
wealth of educational
tools, including the
Patient Education Guide,
the Patient Pocket Guide,
and a video.

Additionally, if you are currently required by the payor to provide a
referral through the payor system you should continue to follow that
procedure. Also if you are required to contact the payor for pre­authorization/authorization to provide professional interpretation for
diagnostic services continue to do so, this will also apply to CardioNet.
When speaking to a payor or claims representative, it is important to
note that CardioNet is not a Holter or event monitor. CardioNet mobile
telemetry is a unique, proprietary technology and service offering, and
is not the equivalent of any other monitoring technology or service.

CardioNet will provide an in-home patient educator to train the patient
on the use of the CardioNet System. CardioNet has a wealth of
resources including in-home educators and print and video training
tools to insure the highest level of patient confidence and compliance.

Important

CardioNet outpatient telemetry is a diagnostic service, not an
emergency response service. It is possible, however, that a patient may
develop a life-threatening arrhythmia while on our service. If we detect
such an event, CardioNet will attempt to assist the patient in accessing
EMS services. Physicians should be aware that our ability to assist
ambulatory patients is limited by many factors including cell phone
coverage, the inherent limitations of GPS locating technology and local
EMS policies.

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Monitoring Specialists Review
and Interpret Data to Ensure
Accuracy

The CardioNet Patient Service Center is staffed
with highly qualified and experienced cardiac

monitoring specialists. At a minimum, all
monitoring specialists are CCT certified. They have extensive
experience in cardiovascular monitoring; including the hospital based
C.C.U. and I.C.U. telemetry, emergency medical services, and other
cardiac call center environments.

As a Medicare provider, CardioNet is licensed as an Independent
Diagnostic Testing Facility (IDTF).

The CardioNet monitoring specialists serve a vital role in responding to
patient and monitor initiated cardiac events. The monitoring specialists
provide a thorough preliminary analysis of the patient’s ECG to insure
that the data is accurate and presented in the appropriate time and
manner as requested by the physician.

All calls are monitored and recorded for quality assurance. CardioNet
requires that all monitoring specialists participate in additional training
and educational programs. A continuous QA process has been
established for all facets of the service center operation.

The monitoring specialists, based on defined physician guidelines,
prepare daily patient summary reports for final physician review and
interpretation. In the case of a patient notification threshold event, the
prescribing physician is contacted immediately and an urgent report is
submitted for review and interpretation. Reports are tailored to the
needs and requirements of the physician and are sent via the Internet,
facsimile, or standard mail.

The CardioNet Patient Service Center is fully staffed and available 7x24,
365 days of the year.

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PATIENT ENROLLMENT

The Patient Enrollment Form is located in the CardioNet Patient
Enrollment and Management System (PEMS). The client can access the
CardioNet Patient Enrollment and Management System application at

www.cardionet.com. This is a secure and restricted website and the user

is required to be enrolled as a CardioNet client. Forms are also available
from the CardioNet Patient Service Center. If you are not a CardioNet
registered user, please contact the Patient Service Center.

Please enter your username and password to log in.

Log in to access the

Username

Password

Login

CardioNet Patient
Enrollment and
Management System.

After you have entered your user name and password, click the log in
button on your screen. You now have access to the CardioNet Patient
Enrollment and Management System. The name of the client, physician
or practice should appear on the upper left of the PEMS application.
You may also refer to the CardioNet

Quick Start Guide

for instructions

on enrolling a patient.

Using the CardioNet navigational tree on the left side, click on
Documents and Forms. A document tab will open with a list of
applicable forms. Click on
a copy. Follow the same process and procedure for

Form

(MON302). Each form must be completed to enroll a patient on

Patient Enrollment Form

(MON300) and print

Patient Prescription

CardioNet’s service.

The Patient Enrollment Form includes patient demographics,
emergency information, primary and secondary insurance, patient
waiver and assignment of benefits. Using this form please input all the
appropriate information in the fields listed. In addition to any insurance
information that is listed on the form, please provide CardioNet with a
copy (front and back) of the patient’s insurance card.

The patient’s signature is required on all enrollment forms prior to
submitting to CardioNet.

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The

Patient Prescription Form

includes the patient name, prescribing
physician, physician group name, and duration of monitoring requested,
diagnosis and ICD-9 code. Using this form input all the appropriate
information in the fields listed. The prescribing physician is required

to

sign the CardioNet

Patient Prescription Form

prior to enrolling

the patient.

Please fax both completed forms, including a copy of the patient’s
insurance card to the CardioNet Patient Service Center.

The enrollment information will be entered into the CardioNet patient
database; the patient’s insurance carrier will be contacted for
preauthorization as required, upon approval, the delivery of the
CardioNet System will be scheduled as soon as possible.

Please see “Sample Forms and Reports” section of this manual for
examples of reports and forms.

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