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Slide1
Physician Reimbursement
Slide2DisclaimerHealth economic and reimbursement information provided by Boston Scientific Corporation is gathered from third-party sources and is subject to change without notice as a result of complex and frequently changing laws, regulations, rules and policies. This information is presented for illustrative purposes only and does not constitute reimbursement or legal advice. Boston Scientific encourages providers to submit accurate and appropriate claims for services. It is always the provider’s responsibility to determine medical necessity, the proper site for delivery of any services and to submit appropriate codes, charges, and modifiers for services that are rendered. Boston Scientific recommends that you consult with your payers, reimbursement specialists and/or legal counsel regarding coding, coverage and reimbursement matters. Boston Scientific does not promote the use of its products outside their FDA-approved label. It is always the provider's responsibility to understand and comply with national coverage determinations (NCD), local coverage decisions (LCD) and any other coverage requirements established by relevant payers which can be updated frequently.
Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your relevant manuals for appropriate coding options.
CPT c
opyright
2017
American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Slide3AgendaMedicare’s Incentive Payment SystemPatient Visits
Pacemaker & Defibrillator Management
Slide4Merit-based Incentive Payment System (MIPS)
Slide5Incentive System Components271 quality measuresAt least 6 must be reportedExample: 30 day all-cause readmission rate for patients 65+https
://
qpp.cms.gov/mips/quality-measures
93 activities: care
coordination, beneficiary engagement,
patient safety
Attest to 2 or 4 activities (15+ providers report 4)
Example: chronic & preventive care management
https://
qpp.cms.gov/mips/improvement-activities
Formerly “Meaningful Use” of EMRSecurity risk analysis, E-prescribing, patient access, health information exchange, etc.https://qpp.cms.gov/mips/advancing-care-informationTotal Capita Cost & Medicare Spending Per Beneficiary (MSPB)Total Capita Cost includes all professional & facility feesHeart failure = biggest expense to MedicareMSPB includes 3 days prior to admission & 30 days after dischargePost-op infections & readmissions are costly
Slide6Penalty/Bonus CalculationsBudget neutral shift ($199m)2020 5% bonus/penalty for 2018 performance2021 7% bonus/penalty for
2019
performance
2022 9%
bonus/penalty for
2020
performance
Additional $
500m/yr
. incentive
Exceptional Performers: up to 3x bonus Top Performers: up to 10% additional bonus
2018 Performance Year Example
Worst possible:
5% penalty
$
100k becomes $95k
Best possible
15% bonus (5% x 3)
+10% top performer = 25% bonus$100k becomes $125kVariance = $30k = 32% of $95K
Same Service Reimbursement Difference
(Between Best & Worst Possible
MIPS Scores
)
Slide7Performance Transparency & LongevityPerformance is posted online for patients and referring physicians to review.
Individual performance carries forward to
new employers.
Poor performers may attract fewer patients and get paid less for seeing them.
Slide8Top 10 Expensive Conditions for Medicare
Cardiology 41%
Source:
Agency for Healthcare Research and Quality (AHRQ), Healthcare Cost and Utilization Project (HCUP), National Inpatient Sample (NIS), 2014
Slide9Optimal Quality Payment Program PerformanceFrequent patient
contact:
Active patient management
Specialized
clinics
Meet reporting requirements
MACRA
bonus will be applied to total
fee-for-service
revenueMinimize services with…High expense to Medicare ANDLow professional revenue
Generator Longevity Data
Slide10Non-Physician vs. Physician Revenue
In MADIT-CRT, an initial HF hospitalization was associated
with a
9-fold
increase
in recurrent
hospitalizations
March
18, 2010 Circulatory System Devices Panel - Boston Scientific,
Inc
: Sponsor Presentation
Slide11Patient Visits
Slide12Patient Visit Documentation GuidelinesHistory (all 3 required)History of Present IllnessReview of Systems
Medical, Family, Social
Hx
.
Exam
Complexity
(2 of 3 required)
History of Present Illness
Review of Systems
Medical, Family, Social
Hx.New patients and admits require history, exam, & complexity
Established patients & hospital follow-up need just 2 of
the 3
The most commonly coded services for cardiology patientsThe most frequently audited services by Medicare
Accuracy is important: under & over coding is bad
Slide13History & Exam Documentation Guidelines
Slide14Complexity Variable # 1: DataEach activity only counts 1x (no multiples)
Any/All of these (2)
1. obtain history from someone other than the patient
2. discuss case w/other provider
3. review & summarize old records
d
iscuss test with performing MD
(1)
review or order radiology work (1)
Either/both of these (2)
1. independent visualization of image
2. independent visualization of tracing
Total Points
New OV Est OV
Initial
Hosp
Subs
. Hosp.
1 99202
99212
99231
2 99203
99213
99221
3 99204
99214
99222
99232
4 99205
99215
99223
99233
review or order medical work (1)
ECG
Echo
Heart Cath
EP Study
Device Check
review or order
lab
work (1)
Slide15Complexity Variable # 2: Presenting Problems
Total Points
New OV Est OV
Initial
Hosp
Subs
. Hosp.
1 99202
99212 99231 2 99203 99213 99221
3 99204 99214
99222
99232 4 99205
99215
99223
99233New
vs.
Established Problem
= “to the examiner” not the patient
Count x Points = Total
Stable
, established problem (1
) ___ x 1 = ___
Worsening, established problem (2
) ___
x
2
= ___
New problem, no work-up planned (3
) ___
x
3
= ___
New problem, work-up planned (4
) ___
x
4
=
___
TOTAL: _____
Slide16Complexity Variable #3: Risk
Risk Level
New OV Est OV
Initial
Hosp
Subs
. Hosp.
1 99202
99212 99231 2 99203 99213
99221
3 99204 99214
99222
99232
4 99205
99215
99223 99233
4
3
2
Credit is earned for the highest level of risk reached by any one variable.
Slide17Initial Inpatient Care99221 – 30 min.99222 – 50 min.99223 – 70 min.
Subsequent Inpatient Care
99231 – 15 min.
99232 – 25 min.
99233 – 35 min.
Inpatient
Consultation
99251 – 20 min.
99252 – 40 min.
99253 – 55 min.
99254 – 80 min.99255 – 110 min.New Pt. Office Visit99201 – 10 min.99202 – 20 min.99203 – 30 min.
99204 – 45 min.99205 – 60 min.Established Pt. Office Visit
99211 – 5 min.99212 – 10 min.99213 – 15 min.99214 – 25 min.
99215 – 40 min.
Outpatient Consultation
99241 – 15 min.
99242 – 30 min.
99243 – 40 min.
99244 – 60 min.99245 – 80 min.
Documentation must establish:
Face-to-Face
time (office) or Unit/Floor time (hospital)
Majority of time was in Counseling or Coordination of Care
Sample 99215:
“
I spent 40 minutes
with the patient;
the majority of this time was
spent discussing heart failure
treatment options.
”
Time-based
Coding & Documentation
Observation Admission
99218 – 30 min.
99219 – 50 min.
99220 – 70 min.
Subsequent Observation Care
99224 – 15 min.
99225 – 25 min.
99226 – 35 min.
Slide18Coding & BillingDevice Management
Slide19HRS/AHA Statements on Remote Monitoring“HRS Expert Consensus Statement on Cardiovascular Implantable Electronic Devices.”Remote monitoring – a Class 1A recommendation“
This consensus document reflects the wealth of recent clinical data generated by large randomized prospective trials from around the world that included patients with pacemakers, ICDs, and CRT-Ds from various manufacturers. These consistently show meaningful patient benefits from the early detection capabilities of automatic
RM
…
These
data form the basis of our recommendations that
RM represents the new standard of care for patients with CIEDs”
AHA “
Abstract 13944
: Early Initiation of Remote Monitoring in CIED Patients is Associated with Reduced Mortality”
“Our data show that survival is higher in patients who have a shorter time between device implant and remote monitoring initiation, across all CIED device types. These data suggest RM should be initiated as soon as possible following device implantation.”early initiation of remote monitoring (within 91 days of device implant) reduces mortality by over 16%...”
Slide20CPT Codes for PM & ICD Remote Monitoring93294 - Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system with interim physician analysis, review(s) and report(s)
($31)
93295
-
Interrogation
device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead implantable cardioverter-
defibrillator
system with interim
physician analysis
, review(s) and report(s)
($56) 93296 - Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system or implantable cardioverter-defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results ($27) 2018 Medicare (national payment)
Slide21Remote Monitoring Billing93294 - Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system with interim physician analysis, review(s) and report(s)
Remote PM/ICD monitoring codes each include:
Up to 90 days of monitoring
One or more evaluations (transmission, review, report)
CPT Instructions
“Do not report 93293,
93294, 93295, 93296
if the monitoring period is less than 30 days”
Typically applies only to initiation & termination of RM
Date of Service
“While we do not have a national policy on this, our sense is that the DOS should be the date of completion.” CMS Director of External Affairs
Slide22Remote Monitoring Billing CycleDate of Service
✅
✅
✅
✅
✅
✅
Slide23Remote Website for Charge Capture
✓
✓
Date of Service
Slide24Flaws With Quarterly ApproachDate of Service
✅
✅
1) Forfeits up to 30 days of RM for 1/3 of newly enrolled patients.
2) Cash flow will be regularly irregular (4 boluses rather than steady stream)
3) If no transmission is received by 90
th
day, loose revenue for missed quarterly cycle
Slide25Creating Three Remote Monitoring GroupsGroup 1: January, February, March – Bill 3/31Group 2: February, March, April – Bill 4/30Group 3: March, April, May –
Bill 5/29
Benefits:
Cash-flow is even every month
New patients get assigned to optimal group
Eliminates loss of up to 30 days RM for 1/3 of new patients
If transmission is missed, bump patient to next monthly cycle
Cut loss from 3 months to 1 month for these
Slide26Legacy Device-Based Heart Failure MonitoringThoracic ImpedancePulmonary edema is a common sign of worsening
HF
TI measures
impedance between
RV electrode and
the pulse
generator
TI may
be associated with
pulmonary fluid level
Worsening heart failure may cause a patient’s fluid level to increaseLimitationsThoracic impedance shifts naturally as leads maturateOnly 21 – 22% sensitivity 1,2E. Kevin Heist, et al., Analysis of Different Device-Based Intrathoracic Impedance Vectors for Detection of Heart Failure Events (from the Detect Fluid Early from Intrathoracic Impedance Monitoring Study), The American Journal of Cardiology, Volume 114, Issue 8, 2014, Pages 1249-1256, ISSN 0002-9149, http://dx.doi.org/10.1016/j.amjcard.2014.07.048.(http://www.sciencedirect.com/science/article/pii/S0002914914015343)
Viviane M. Conraads, Luigi
Tavazzi, Massimo Santini,
Fabrizio Oliva, Bart Gerritse,
Cheuk
-Man Yu, Martin R. Cowie; Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial.
Eur
Heart J 2011; 32 (18): 2266-2273.
doi: 10.1093/eurheartj/ehr050
Only one of these patients had a HF event after TI dropped.
Slide27HeartLogicTM Heart Failure Diagnostic Boehmer, J et al., JACC-HF, 2017;5(3),2 1 6 – 2 5
Heart Sounds
S1 & S3
Impedance
Thoracic
Respiration
Rate & Volume
Activity
Time Spent Active
Heart Rate
Night
multiple sensor measurements combined into
a single, simple index with alert
Available on
LATITUDE
™
NXT
for patients with
Resonate
™
family of
ICDs & CRT-Ds
HeartLogic
™
shifts heart failure patient management from reactive treatment to
proactive
care,
and was validated in the MultiSENSE Study to have:
High
sensitivity
of 70% for
detecting
heart
failure events
Weeks of advance
notice
of a potential heart failure event
Low burden
of less than 2
alerts
per patient per
year
Slide28Benefit of Multi-Sensor Approach
100
50
0
2.2
1.4
0.6
4.8
3.2
1.6
22
18
14
49
39
29
1
00
50
0
1.1
0.8
0.5
3.4
2.6
1.8
18
16
14
59
55
51
HeartLogic
TM
S3
S1
Respiration
Thoracic
Impedance
Patient
A
Multi-sensor Changes before a
HF Event
Patient
B
Impedance-only Change with NO Event
Two Observed Cases
Results from
the case studies are
not necessarily predictive of
results in
other cases.
Results
in other cases may vary
.
Slide29100 Patient Scenario (statistic-based projection)Rehospitalizations among Patients in the Medicare Fee for Service Program Stephen F. Jencks, M.D., M.P.H.,
E
. Kevin Heist, et al., Analysis of Different Device-Based Intrathoracic Impedance Vectors for Detection of Heart Failure Events (from the Detect Fluid Early from Intrathoracic Impedance Monitoring Study), The American Journal of Cardiology, Volume 114, Issue 8, 2014, Pages 1249-1256, ISSN 0002-9149, http://
dx.doi.org
/10.1016/j.amjcard.2014.07.048.(http://
www.sciencedirect.com
/science/article/
pii
/S0002914914015343)
Viviane M.
Conraads, Luigi Tavazzi, Massimo Santini, Fabrizio Oliva, Bart Gerritse, Cheuk-Man Yu, Martin R. Cowie; Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial. Eur Heart J 2011; 32 (18): 2266-2273. doi
: 10.1093/eurheartj
/ehr050A Multisensor Algorithm Predicts Heart Failure Events in Patients With Implanted Devices., John P.
Boehmer, et al., JACC: Heart Failure Mar 2017, 5 (3) 216-225; DOI: 10.1016/j.jchf.2016.12.011
Beckers
Hospital Review, 6 Stats on the Cost of Readmission for CMS- Tracked Conditions December 12,
2013
No
HF Diagnostics
1
Impedance
Alone
2,3 Avg
.
21% Specificity
HeartLogic
4
70% Specificity
Readmissions
27
21
8
Cost
$
13,000
5
$351,000
$273,000
$104,000
M/C Savings
$0
$78,000
$247,000
Hospital Loss
$54,000
$42,000
$16,000
Slide30CPT Codes for Heart Failure Remote Monitoring93297 - Interrogation device evaluation(s), (remote) up to
30 days;
implantable cardiovascular monitor system, including analysis of 1 or more recorded physiologic cardiovascular data elements from all internal and external sensors, physician analysis, review(s) and report(s)
($27)
93299
- Interrogation
device
evaluation(s)
, (remote) up to
30 days
; implantable cardiovascular monitor system or implantable loop recorder system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results (contractor priced)✅Date of Service
2018 Medicare (national payment)
Slide312018 Contractor Pricing for 93299Palmetto GBA $23 - $29Wisconsin Physician Services $
118 - $136
National
Government Services
$
26 - $275
CGS
Administrators
$
29
Noridian Healthcare Solutions $13 (2017)Novitas $38 - $53 Cahaba GBA $29 First Coast Service Options $34 - $38 Average Payment: $65/month
Slide32JACC 10/2/12 “Minimum Frequency” GuidelinesIn Person Device Checks:Within 72 hours of device implantation
2–
12
weeks after device implantation
Annually
until battery
depletion
Additional
In Person or Remote Checks:
Pacemakers: every 3 – 12 months
Defibrillators: every 3 – 6 monthsSigns of battery depletion (PM & ICD): 1 – 3 monthsMore frequent checks are expected
Slide33In-Clinic PM/ICD Device Checks
Medicare requires direct supervision of device checks done by physician practice employees. Direct supervision means the physician is immediately available in the office suite to furnish assistance but is not required to be in the room where the device check is being performed.
https://
www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R169BP.pdf
“
The final program parameters
may or may not change
after evaluation
”
CPT Instruction
Slide34In-Clinic Interrogations During Remote Monitoring
Heart Failure Data
Pacemaker/Defibrillator Data
AAPC Coder/Correct Coding Initiative Edits
93297
–
Remote HF Professional
93299
–
Remote HF Technical
93295 – Remote PM Professional
93296 – Remote ICD Technical
Slide35Device Clinic & Same Day Patient VisitVisits are separately billable in many cases:The visit must be medically necessaryDocumented to support the level of service billedIn excess of the basic device check interactionBilling pointers:Modifier 25 (significant & separately identifiable service) is required on the visit code by some payers.
The diagnosis code(s) for the visit need to reflect the medical necessity for the visit (arrhythmia, CHF, etc.)
The diagnosis codes for the check should reflect the indication for the device and the programming evaluation codes:
Pacemaker: Z45.010 (generator)
AND
Z45.018 (electrodes)
Defibrillator: Z45.02 (system evaluation)
Slide36Device Clinic StaffingCMS Transmittal 135“The supervision requirement for physician billing is not met when the test is administered by supplier personnel” American College of Cardiology“If the physician doesn’t own the equipment or pay the personnel, he or she should bill only the professional component.”Heart Rhythm Society
“individual performing the evaluation must be employed by the MD in order to bill globally for the professional and technical services”
“Medicare guidelines prohibit a physician from reporting the technical component of services performed by IEAP who is not employed by the physician.”
Modifier 26 (Professional Component)
93284-26 (Bi-V ICD programming evaluation
–
professional component)
26 modifier reduces compensation from $92 to $64 ($28)
Slide37Annualized RevenueDefibrillator + Heart FailureIn person services:93283 X 2 ($80 x 2)
$160
99214 X 2 ($
109
x 2)
$218
Remote
device monitoring:
93295 X 4 ($56 x 4) $22493296 X 4 ($27 x 4) $108Remote heart failure monitoring:93297 X 12 ($27 x 12) $32493299 X 12 ($65 x 12) $780Annual Revenue: $1,834Pacemaker Without Heart Failure
In person:93280 X 1 $39
99214 X 1 $109
Remote device monitoring:93294 X 4 ($31 x 4) $125
93296 X 4 ($
27
x 4)
$108Annual Revenue: $3822018 CMS National fees used for all but 93299 ($
6
5
used for it)
Slide38Here’s what we covered…Medicare’s Incentive Payment SystemPatient
Visits
Device Management
Slide39Presenter InformationJim Collins, CPC, CCC President, CardiologyCoder.Com, Inc.Cardiology coding guru for
over 20
years
W
rote
the study guide and certification exam for the American Academy of Professional Coders
(AAPC) called
“Certified Cardiology
Coder”
Co-developed the certification exam for the Board of Advanced Medical Coding called "Advanced Coding Specialist in Cardiology" Consulting Editor of "Cardiology Coding Alert” for over a decade. Several articles published in ”EP Lab Digest” & ”Cath Lab Digest”Please contact Jim if you have follow-up questions or additional needs.@CardiologyCoder
518.320.4376
Jim@CardiologyCoder.Com
Slide40GuidePoint Is Simplifying Reimbursement
Call 1.800.CARDIAC (227.3422) and ask for the
Reimbursement Customer Support Line.
Reimbursement Customer Support Line
Get your CRM and EP reimbursement questions answered.
• Make the website your first stop for all your Boston Scientific
CRM and EP reimbursement needs, access
http://www.bostonscientific.com/crm/reimbursement
GuidePoint
Website
Keep current with the latest CRM
and EP reimbursement news and find
other reimbursement education resources.
Webcast Programs
Hear from nationally acclaimed experts
addressing basic and advanced CRM and
EP reimbursement topics.
We’re dedicated to providing physicians and allied health professionals with
world-class
programs and services to help advance the standard of patient care
.
CRM Billing
and Coding Guide
Quickly find coding and billing information,
including scenarios specific to CRM and
EP procedures.
We are proud to continue this
spirit
of partnership with GuidePoint.
Field
Reimbursement
Team
Specialized
on-site support for documentation and
coding education
related to
IC, PI,
and
CRM-EP
procedures.
Slide41HeartLogic™ Training Resource
Learnings include:
A 1-hour CEU interactive training program covering
Key takeaways from the
MultiSENSE
study
HeartLogic
TM
overview
Configuring
HeartLogic
TM
within LATITUDE™ NXTManaging
HeartLogic
TM
Alerts
V
ideosLinks to available resourcesFAQsSubmit your own case study
HeartLogic
TM
Heart Failure Diagnostic Learning
Center
www.HeartLogictraining.com
L
earn
about
HeartLogic
TM
,
which was validated in the MultiSENSE
Study
to detect the
early warning signs of worsening heart failure
by combining data from
5 sensors into a single composite index
.
Slide42Brief SummaryCRT-D Systems –RESONATE™HF, RESONATE™, RESONATE™X4, VIGILANT™, VIGILANT™X4, MOMENTUM™, MOMENTUM™ X4INDICATIONS AND USAGEThese Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications: Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120
ms
; left bundle branch block (LBBB) with QRS duration ≥ 130
ms
, EF ≤ 30%, and mild (NYHA Class II) ischemic or
nonischemic
heart failure or asymptomatic (NYHA Class I) ischemic heart failure
CONTRAINDICATIONS
There are no contraindications for this device.
WARNINGS
Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. For single patient use only. Do not reuse, reprocess, or resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Do not use defibrillation patch leads with the pulse generator system. Do not use this pulse generator with another pulse generator. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures. Do not kink, twist, or braid the lead with other leads. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not contact any other portion of the IS4–LLLL lead terminal, other than the terminal pin, even when the lead cap is in place. When implant a system that uses both a DF4–LLHH or DF4–LLHO and IS4–LLLL lead, ensure that the leads are inserted and secured in the appropriate ports. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Do not use atrial-only modes in patients with heart failure. Left ventricular lead dislodgement to a position near the atria can result in atrial oversensing and left ventricular pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. RESONATE HF, RESONATE, and VIGILANT devices with an IS-1/DF4/IS4 lead connection are considered MR Conditional. For these devices, unless all of the MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system, and significant harm to or death of the patient and/or damage to the implanted system may result. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide.. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. If desired, ensure that Patient Triggered Monitor (PTM) is enabled prior to sending the patient home by confirming the magnet response is programmed to Store EGM. Once the PTM feature has been triggered and the magnet response set to Inhibit therapy the patient should not reapply the magnet.
PRECAUTIONS
For specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal, supplemental precautionary information. Advise patients to avoid sources of EMI because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.
POTENTIAL ADVERSE EVENTSPotential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks /pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.(Rev B)
Slide43Brief SummaryICD Systems – RESONATE™ HF, RESONATE™ EL, PERCIVA™ HF, PERCIVA™, VIGILANT™ EL, MOMENTUM™ EL INDICATIONS AND USAGEBoston Scientific implantable cardioverter defibrillators (ICDs) are intended to provide ventricular antitachycardia
pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.
CONTRAINDICATIONS
Use of these Boston Scientific pulse generators are contraindicated for the following: patients whose ventricular
tachyarrhythmias
may have reversible cause, such as: digitalis intoxication, electrolyte imbalance, hypoxia, sepsis; or patients whose ventricular
tachyarrhythmias
have a transient cause, such as: acute myocardial infarction (MI), electrocution, drowning; or patients who have a unipolar pacemaker.
WARNINGS
Read this manual thoroughly before implantation to avoid damage to the pulse generator and/or lead. For single patient use only. Do not reuse, reprocess, or
resterilize. Always have external defibrillation equipment available during implant and electrophysiologic testing. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing should the patient require external rescue. Do not use this pulse generator with another pulse generator. Program the pulse generator Tachy Mode(s) to Off during implant, explant, or postmortem procedures to avoid inadvertent high voltage shocks. Do not kink, twist, or braid the lead with other leads as doing so could cause lead insulation abrasion damage or conductor damage. For leads that require the use of a Connector Tool, use caution handling the lead terminal when the Connector Tool is not present on the lead. Do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4–LLHH or DF4–LLHO lead terminal, other than the terminal pin, even when the lead cap is in place. Do not use atrial tracking modes in patients with chronic refractory atrial tachyarrhythmias. Tracking of atrial arrhythmias could result in ventricular tachyarrhythmias. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. RESONATE HF, RESONATE, PERCIVA HF, PERCIVA, and VIGILANT devices with a DF4 right ventricular lead connection are considered MR Conditional. For these devices, unless all of the MRI Conditions of Use are met, MRI scanning of the patient does not meet MR Conditional requirements for the implanted system, and significant harm to or death of the patient and/or damage to the implanted system may result. For potential adverse events applicable when the Conditions of Use are met or not met, refer to the MRI Technical Guide. Do not subject a patient with an implanted pulse generator and/or lead to diathermy. If desired, ensure that Patient Triggered Monitor is enabled prior to sending the patient home. Once the Patient Triggered Monitor feature has been triggered by the magnet and an EGM has been stored, or after 60 days have elapsed from the day that Store EGM was enabled, the patient should not apply the magnet.
PRECAUTIONSFor specific information on precautions, refer to the following sections of the product labeling: clinical considerations, sterilization and storage, implantation, device programming, environmental and medical therapy hazards, hospital and medical environments, home and occupational environments, follow-up testing, explant and disposal, and supplemental precautionary information.
POTENTIAL ADVERSE EVENTS
Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks /pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.(Rev B)
Slide44Brief Summary – LATITUDE™ NXT LATITUDE™ NXT Patient Management SystemIntended UseThe LATITUDE™ NXT Patient Management System is intended for use to remotely communicate with a compatible pulse generator from Boston Scientific CRM and transfer data to a central database. The LATITUDE NXT System provides patient data that can be used as part of the clinical evaluation of the patient.Contraindications
The LATITUDE NXT Patient Management System is contraindicated for use with any implanted device other than a compatible Boston Scientific implanted device. Not all Boston Scientific implanted devices are compatible with the LATITUDE NXT System. For contraindications for use related to the implanted device, refer to the System Guide for the Boston Scientific implanted device being interrogated.
Precautions
Alerts may appear on the LATITUDE NXT website on a daily basis. Primary notification of alert conditions is through the View Patient List page on the LATITUDE NXT website. The clinician needs to log onto the LATITUDE NXT website in order to receive alerts. Although secondary notification through email and SMS
text messages is available, these reminders are dependent on external systems and may be delayed or not occur. The secondary notification feature does not eliminate or reduce the need to check the website. Implanted device data and alerts are typically available for review on the LATITUDE NXT website within 15 minutes of a successful interrogation. However, data uploads may take significantly longer (up to 14 days). If the Communicator is unable to interrogate the implanted device or if the Communicator is unable to contact the LATITUDE NXT server to upload data, up to 14 days may elapse before the LATITUDE NXT server detects these conditions and informs the clinic user that monitoring is not occurring. If both of these conditions occur at the same time, this notification could take up to 28 days. Implanted device data and alert notification may be delayed or not occur at all under various conditions, which include but are not limited to the following: System limitations; the Communicator is unplugged; the Communicator is not able to connect to the LATITUDE NXT server through the configured phone system; the implanted device and the Communicator cannot establish and complete a telemetry session; the Communicator is damaged or malfunctions; the patient is not compliant with prescribed use or is not using the
LATITUDE NXT System as described in the patient manual; if subscribed to the LATITUDE Cellular Data Plan, missing two or more payments discontinues the subscription; the clinic user can identify any patients that are not being monitored as described above by using the Not Monitored filter on the View Patient List.
Adverse Effects:
None known.
System Limitations:
The LATITUDE NXT System does not provide continuous real-time monitoring. As a remote monitoring system, the LATITUDE NXT System provides periodic patient monitoring based on clinician configured settings. There are many internal and external factors that can hinder, delay, or prevent acquisition and delivery of implanted device, sensor, and patient information as intended by the clinician. These factors include: implanted device clock; patient environment; cellular data service; telephone system; communicator memory capacity; clinic environment; schedule/configuration changes; or data processing.
Refer to the product labeling for specific instructions for use. Rx only. (Rev. D)