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Hospital and Physician Reimbursement Guide for ICD Implants JULY 2014 CRDM Economics and Health Policy

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Page 1: Hospital and Physician Reimbursement Guide for ICD …€¦ · The SCD-HeFT population is broader, for example, a prior MI is a MADIT-II indication, but may or may not be present

Hospital and Physician Reimbursement Guide for ICD ImplantsJULY 2014

CRDM Economics and Health Policy

Page 2: Hospital and Physician Reimbursement Guide for ICD …€¦ · The SCD-HeFT population is broader, for example, a prior MI is a MADIT-II indication, but may or may not be present

Hospital and Physician Reimbursement Guide for ICD Implants 1 of 22 July 2014

Hospital and Physician Reimbursement Guide for ICD ImplantsThis guide has been developed to help you understand Medicare coverage and payment for implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D).

These coding suggestions and coverage guidelines do not replace seeking coding advice from the payer and/or your coding staff. The ultimate responsibility for correct coding lies with the provider of services. Please contact your local payer for interpretation of the appropriate codes to use for specific procedures. Medtronic makes no guarantee that the use of this information will prevent differences of opinion or disputes with Medicare or other third party payers as to the correct form of billing or the amount that will be paid to providers of service.

Table of ContentsOverview ......................................................................................................................................................................................................... 2

Coverage for ICD Therapy .................................................................................................................................................................... 4

Coding for ICD Therapy ......................................................................................................................................................................... 9

Inpatient Hospital MS-DRGs for ICD Therapy ....................................................................................................................... 18

Medicare Implant Registry ............................................................................................................................................................... 19

Frequently Asked Questions ........................................................................................................................................................... 20

CPT copyright 2013 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 practice medicine or dispense medical services. The AMA assumes no liability for the data contained or not contained herein.

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Hospital and Physician Reimbursement Guide for ICD Implants July 2014 2 of 22

OverviewThe implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating. When the device senses an arrhythmia, it sends an electrical signal through the leads to terminate the arrhythmia and restore normal heart rhythm.

On January 27, 2005 Medicare expanded their covered indications and as a result they identified two different patient classifications; Primary Prevention and Secondary Prevention.

Secondary Prevention

ICDs are also used for “secondary prevention” in individuals with known arrhythmias and also in those who have survived an episode of sudden cardiac arrest.

The history of Medicare coverage for implantable automatic defibrillators1:

• January 24, 1986: Coverage to treat life-threatening ventricular tachyarrhythmias.

• July 1, 1999: Expanded coverage for additional types of cardiac patients.

• October 1, 2003: Expanded coverage for patients with a documented prior myocardial infarction (MI).

• January 27, 2005: Expanded coverage based on the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT)

Primary PreventionICDs are used for “primary prevention” for individuals who have a high risk of life-threatening arrhythmias due to a variety of risk factors.

MADIT-II and SCD-HeFT PatientsMADIT-II and SCD-HeFT were two clinical trials that studied the impact of ICD therapy on specific patient populations. Both trials demonstrated decreased risk of death from sudden cardiac arrest for patients who receive an ICD. MADIT-II patients have survived a previous myocardial infarction (MI) and have impairment of the left ventricle, but no prior history of an arrhythmia. MADIT-II and SCD-HeFT patient populations overlap. The SCD-HeFT population is broader, for example, a prior MI is a MADIT-II indication, but may or may not be present in a SCD-HeFT patient. Both populations may include abnormalities in QRS duration.

Patient Population Summary

MADIT-II SCD-HeFTPrior MI Ischemic or nonischemic cardiomyopathyEF ≤ 30% NYHA Class II or III

EF ≤ 35%

Overview

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Hospital and Physician Reimbursement Guide for ICD Implants 3 of 22 July 2014

OVERVIEW, continued

Medicare ICD RegistryWith the expanded coverage in 2005, Medicare also introduced the requirement of an ICD registry to collect information about primary prevention patients. An implant registry is currently maintained by the American College of Cardiology’s National Cardiovascular Data Registry (ACC-NCDR®). Hospitals must enter their Medicare primary prevention patients in the registry as a condition for Medicare coverage, with some exceptions. Hospitals may choose to enter all of their ICD and CRT-D patients into the registry. The existence of the ACC-NCDR registry, which was launched on April 3, 2006, subsequently expanded Medicare coverage to patients diagnosed with:

• Nonischemic dilated cardiomyopathy (NIDCM) > 3 months and < 9 months, and

• NYHA Class II or III heart failure, and

• Measured LVEF ≤ 35% if they participated in the ACC-NCDR ICD registry

For further clarification, visit the Medicare website: http://www.cms.gov/MedicareApprovedFacilitie/04_ICDregistry.asp or visit the National Cardiovascular Data Registry website: http://www.ncdr.com.

Cardiac Resynchronization Therapy with DefibrillatorCardiac resynchronization therapy with defibrillator (CRT-D) combines the benefits of defibrillation with synchronous biventricular pacing capabilities. CRT-D is used in individuals who qualify for an ICD and who also have indications for CRT.

Medicare does not have a national coverage determination specifically for CRT-D therapy. As CRT-D combines the benefits of defibrillation with synchronous biventricular pacing capabilities, it is important that the patient first and foremost meets the national coverage indications for an ICD. To determine if the biventricular pacing capabilities are warranted, the current indications for biventricular pacing and supporting literature should be considered. Please contact your local payer’s medical director for more specific information regarding the coverage policies for your area.

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Hospital and Physician Reimbursement Guide for ICD Implants July 2014 4 of 22

Coverage for ICD TherapyMedicare CoverageTypically, Medicare does not provide prior authorization for services. The Medicare coverage policy for ICD implants occurring on or after January 27, 2005 is printed verbatim; however, it is reformatted for easier readability. Note that in this policy, coverage has been extended to the SCD-HeFT2 population.

The Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT),2 a landmark clinical trial in heart failure (HF) and cardiology, compares the efficacy of implantable cardioverter defibrillators (ICDs), amiodarone, and placebo in treating 2,521 patients with an ejection fraction of 35% or lower and NYHA Functional Class II or III symptoms. Patients within NYHA Class II have symptoms with ordinary exertion, while NYHA Class III patients have symptoms with less than normal exertion. The National Institutes of Health’s National Heart, Lung, and Blood Institute conducted the SCD-HeFT clinical study as an independent trial, with funding from Medtronic, Inc. and Wyeth Ayerst. The study found that ICDs provided a 23% relative reduction in all-cause mortality as compared to the placebo. This mortality benefit was observed in patients who were already optimally managed on drug therapy. Amiodarone had no significant effect on all-cause mortality. Patients with SCD-HeFT indications have not experienced a sudden cardiac arrest (SCA), and hence their treatment with ICD therapy is considered to be a “primary prevention” measure.

The Multicenter Automatic Defibrillator Implantation Trial II (MADIT-II)3 studied the benefit of ICD therapy in patients with a prior myocardial infarction (MI), a left ventricular ejection fraction (LVEF) of 30% or lower, and who were in NYHA Functional Class I, II, or III at the time of enrollment. NYHA Class I patients have symptoms with greater than normal exertion. The study demonstrated a 31% relative reduction in mortality in patients who had ICDs, compared to those in the optimized medical therapy group.

Medicare Coverage Policy20.4 IMPLANTABLE AUTOMATIC DEFIBRILLATORS, Medicare National Coverage Determinations Manual (Chapter 1, Part I (Sections 10-80.12) Coverage Determinations)*

A. General The implantable automatic defibrillator is an electronic device designed to detect and treat life-threatening tachyarrhythmias. The device consists of a pulse generator and electrodes for sensing and defibrillating.

B. Covered Indications 1. Documented episode of cardiac arrest due to ventricular fibrillation (VF), not due to a transient

or reversible cause (effective July 1, 1991).

2. Documented sustained ventricular tachyarrhythmia (VT), either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI) and not due to a transient or reversible cause (effective July 1, 1999).

3. Documented familial or inherited conditions with a high risk of life-threatening VT, such as Long QT syndrome or hypertrophic cardiomyopathy (effective July 1, 1999).

* The coverage policy is available at http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110&ncdver=3&IsPopup=y&NCAId=102&NcaName=Implantable+Defibrillators+-+Clinical+Trials&bc=AAAAAAAAIAAA&.

Coverage for ICD

Therapy

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Hospital and Physician Reimbursement Guide for ICD Implants 5 of 22 July 2014

COVERAGE FOR ICD THERAPY, continued

Additional indications effective for services performed on or after October 1, 2003: 4. Coronary artery disease with a documented prior MI, a measured left ventricular ejection fraction

(LVEF) ≤ 0.35, and inducible, sustained VT or VF at EP study. (The MI must have occurred more than 40 days prior to defibrillator insertion. The EP test must be performed more than 4 weeks after the qualifying MI.)

5. Documented prior MI and a measured LVEF ≤ 0.30 and a QRS duration of > 120 milliseconds (the QRS restriction does not apply to services performed on or after January 27, 2005). Patients must not have:

a. New York Heart Association (NYHA) Classification IV; b. Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; c. Had a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty

(PTCA) within past 3 months; d. Had an enzyme positive MI within past month (Effective for services on or after January 27, 2005,

patients must not have an acute MI in the past 40 days); e. Clinical symptoms or findings that would make them a candidate for coronary revascularization; or f. Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a

likelihood of survival less than 1 year.

Additional indications effective for services performed on or after January 27, 2005:

6. Patients with ischemic dilated cardiomyopathy (IDCM), documented prior MI, NYHA Class II and III heart failure, and measured LVEF ≤ 35%;

7. Patients with nonischemic dilated cardiomyopathy (NIDCM) > 9 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35%;

8. Patients who meet all current Centers for Medicare & Medicaid Services (CMS) coverage requirements for a cardiac resynchronization therapy (CRT) device and have NYHA Class IV heart failure;

All indications must meet the following criteria: a. Patients must not have irreversible brain damage from preexisting cerebral disease; b. MIs must be documented and defined according to the consensus document of the Joint

European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction4;

Indications 3-8 (primary prevention of sudden cardiac death) must also meet the following criteria: a. Patients must be able to give informed consent; b. Patients must not have: • Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; • Had a CABG or PTCA within the past 3 months; • Had an acute MI within the past 40 days; • Clinical symptoms or findings that would make them a candidate for coronary revascularization; • Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a

likelihood of survival less than 1 year; c. Ejection fractions must be measured by angiography, radionuclide scanning, or

echocardiography;

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Hospital and Physician Reimbursement Guide for ICD Implants July 2014 6 of 22

COVERAGE FOR ICD THERAPY, continued

d. The beneficiary receiving the defibrillator implantation for primary prevention is enrolled in either a Food and Drug Administration (FDA) approved category B investigational device exemption (IDE) clinical trial (42 CFR §405.201), a trial under the CMS Clinical Trial Policy (National Coverage Determination (NCD) Manual §310.1), or a qualifying data collection system including approved clinical trials and registries. Initially, an implantable cardiac defibrillator (ICD) database will be maintained using a data submission mechanism that is already in use by Medicare participating hospitals to submit data to the Iowa Foundation for Medical Care (IFMC) – a Quality Improvement Organization (QIO) contractor – for determination of reasonable and necessary and quality improvement. Initial hypothesis and data elements are specified in this decision (Appendix VI) and are the minimum necessary to ensure that the device is reasonable and necessary. Data collection will be completed using the ICDA (ICD Abstraction Tool) and transmitted via QNet (Quality Network Exchange) to the IFMC who will collect and maintain the database. Additional stakeholder-developed data collection systems to augment or replace the initial QNet system, addressing at a minimum the hypotheses specified in this decision, must meet the following basic criteria:

• Written protocol on file; • Institutional review board review and approval; • Scientific review and approval by two or more qualified individuals who are not part of the

research team; • Certification that investigators have not been disqualified.

For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.

e. [Was not included in the original publication.] f. Providers must be able to justify the medical necessity of devices other than single lead devices.

This justification should be available in the patient’s medical record.

9. Patients with NIDCM > 3 months, NYHA Class II or III heart failure, and measured LVEF ≤ 35%, only if the following additional criteria are also met: a. Patients must be able to give informed consent; b. Patients must not have:

• Cardiogenic shock or symptomatic hypotension while in a stable baseline rhythm; • Had a CABG or PTCA within the past 3 months; • Had an acute MI within the past 40 days; • Clinical symptoms or findings that would make them a candidate for coronary revascularization; • Irreversible brain damage from preexisting cerebral disease; • Any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a

likelihood of survival less than 1 year; c. Ejection fractions must be measured by angiography, radionuclide scanning, or

echocardiography;d. MIs must be documented and defined according to the consensus document of the Joint

European Society of Cardiology/American College of Cardiology Committee for the Redefinition of Myocardial Infarction4;

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Hospital and Physician Reimbursement Guide for ICD Implants 7 of 22 July 2014

COVERAGE FOR ICD THERAPY, continued

e. The beneficiary receiving the defibrillator implantation for this indication is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR §405.201), a trial under the CMS Clinical Trial Policy (NCD Manual §310.1), or a prospective data collection system meeting the following basic criteria:

• Written protocol on file; • Institutional Review Board review and approval; • Scientific review and approval by two or more qualified individuals who are not part of the

research team; • Certification that investigators have not been disqualified.

For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.

f. Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient’s medical record.

C. Other Indications

All other indications for implantable automatic defibrillators not currently covered in accordance with this decision will continue to be covered under Category B IDE trials (42 CFR §405.201) and the CMS routine clinical trials policy (NCD §310.1).

Please see the following page for a Medicare ICD/CRT-D coverage overview chart.

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Hospital and Physician Reimbursement Guide for ICD Implants July 2014 8 of 22

COVERAGE FOR ICD THERAPY, continued

Medicare ICD/CRT-D Coverage Overview Chart

Ejection Fraction*

NYHA Class Indication Exclusions or Other Conditions

Seco

ndar

y Pr

even

tion

Not stated Not stated Documented episode of cardiac arrest due to ventricular fibrillation (VF)

• Not due to a transient or reversible cause

• Must not have irreversible brain damage from preexisting cerebral disease

Not stated Not stated Documented sustained ventricular tachyarrhythmia (VT)**, either spontaneous or induced by an electrophysiology (EP) study, not associated with an acute myocardial infarction (MI)***

• Not due to a transient or reversible cause

• Must not have irreversible brain damage from preexisting cerebral disease

Prim

ary

Prev

entio

n

Not stated Not stated Documented familial or inherited conditions with a high risk of life-threatening VT, such as long QT syndrome or hypertrophic cardiomyopathy

• Patient is enrolled in either an FDA-approved category B IDE clinical trial, a trial under the CMS Clinical Trial Policy, or a qualifying data collection system including approved clinical trials and registries. At the present time, the ICD Registry™ qualifies as a data collection system.

• Providers must be able to justify the medical necessity of devices other than single lead devices. This justification should be available in the patient’s medical record.

• Patients must be able to give informed consent

• Patients must not have:– irreversible brain damage from preexisting

cerebral disease;– cardiogenic shock or symptomatic

hypotension while in a stable baseline rhythm;

– had a CABG or PTCA within the past 3 months;– had an acute MI*** within the past 40 days;– clinical symptoms or findings that would

make them a candidate for coronary revascularization;

– any disease, other than cardiac disease (e.g., cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.

≤ 30% MADIT-II included all

but IV

Documented prior MI***

≤ 35% All but IV Coronary artery disease with a documented prior MI*** that occurred > 40 days prior to the defibrillator insertion, and inducible, sustained VT or VF at EP study performed > 4 weeks after MI.

≤ 35% II, III Ischemic dilated cardiomyopathy with documented prior MI*** or non-ischemic dilated cardiomyopathy > 3 months

≤ 35% IV CMS coverage requirements for a cardiac resynchronization therapy device

Note: Check with your local Medicare contractor regarding coverage requirements for a cardiac resynchronization therapy device.

* Ejection fractions must be measured by angiography, radionuclide scanning, or echocardiography. ** The ICD Registry™ includes the following definition of spontaneous sustained VT: Spontaneous VT lasts > 30 seconds in duration or requires termination due

to hemodynamic compromise in < 30 seconds. *** MIs must be documented and defined according to the consensus document of the Joint European Society of Cardiology/American College of Cardiology

Committee for the Redefinition of Myocardial Infarction.

Coverage with Non-Medicare PayersNon-Medicare payers typically determine coverage for procedures based on prior authorization. With ICD patients, unless you are aware of the payer’s coverage policy for a specific patient population, we recommend that you contact the payer to seek prior authorization. Asking about coverage after implant may result in unpaid claims, leaving both the hospital and the physician without compensation. Be sure to allow sufficient time to obtain prior authorization.

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Hospital and Physician Reimbursement Guide for ICD Implants 9 of 22 July 2014

Coding for ICD TherapyThese coding suggestions do not replace seeking coding advice from the payer and/or your own coding staff. The ultimate responsibility for correct coding lies with the provider of services. All diagnosis and procedure codes must be supported by clear documentation within the medical record.

Physician Procedure Codes The following CPT®5 codes describe procedures associated with ICD Therapy implants. Depending on the type of ICD implanted, one or a combination of the following codes may be appropriate:

CPT Code CPT Code Description

33202 Insertion of epicardial electrode(s); open incision (e.g., thoracotomy, median sternotomy, subxiphoid approach)

33203 Insertion of epicardial electrode(s); endoscopic approach (e.g., thoracoscopy, pericardioscopy)

33216 Insertion of a single transvenous electrode, permanent pacemaker or cardioverter-defibrillator

33217 Insertion of 2 transvenous electrodes, permanent pacemaker or cardioverter-defibrillator

33224 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or pacing cardioverter-defibrillator pulse generator (including revision of pocket, removal, insertion, and/or replacement of existing generator)

+33225 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of pacing cardioverter-defibrillator or pacemaker pulse generator (including upgrade to dual chamber system and pocket revision) (List separately in addition to code for primary procedure)

33230 Insertion of pacing cardioverter-defibrillator pulse generator only; with existing dual leads

33231 Insertion of pacing cardioverter-defibrillator pulse generator only; with existing multiple leads

33240 Insertion of pacing cardioverter-defibrillator pulse generator only; with existing single lead

33241 Removal of pacing cardioverter-defibrillator pulse generator only

33249 Insertion or replacement of permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber

33262 Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; single lead system

33263 Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; dual lead system

33264 Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; multiple lead system

+ Add-on code

Codi

ng fo

r ICD

Th

erap

y

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Hospital and Physician Reimbursement Guide for ICD Implants July 2014 10 of 22

CODING FOR ICD THERAPY, continued

Hospital Inpatient Procedure CodesThe following ICD-9-CM codes describe procedures performed in a hospital inpatient setting. Depending on the type of ICD implanted, one or a combination of the following codes may be appropriate.

ICD-9-CMProcedure

CodeICD-9-CM Procedure Code Description

00.51 Implantation of cardiac resynchronization defibrillator, total system (CRT-D)

00.52 Implantation or replacement of transvenous lead (electrode) into left ventricular coronary venous system

00.54 Implantation or replacement of cardiac resynchronization defibrillator pulse generator device only (CRT-D)

37.74 Insertion or replacement of epicardial lead (electrode) into epicardium

37.94 Implantation or replacement of automatic cardioverter-defibrillator, total system (AICD)

37.95 Implantation of automatic cardioverter-defibrillator lead(s) only

37.96 Implantation of automatic cardioverter-defibrillator pulse generator only

37.97 Replacement of automatic cardioverter-defibrillator lead(s) only

37.98 Replacement of automatic cardioverter-defibrillator pulse generator only

ICD Generator Replacement (MS-DRG 245)

ICD-9-CMProcedure

Code

ICD-9-CMProcedure Code Description

00.54 Implantation or replacement of cardiac resynchronization defibrillator pulse generator device only [CRT-D]

37.96 Implantation of automatic cardioverter-defibrillator pulse generator only37.98 Replacement of automatic cardioverter-defibrillator pulse generator only

ICD Lead Replacement (MS-DRG 265)

ICD-9-CMProcedure

Code

ICD-9-CMProcedure Code Description

00.52 Implantation or replacement of transvenous lead [electrode] into left ventricular coronary venous system

37.95 Implantation of automatic cardioverter-defibrillator lead(s) only37.97 Replacement of automatic cardioverter-defibrillator lead(s) only

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CODING FOR ICD THERAPY, continued

Hospital Outpatient Procedure CodesThe following CPT5 codes describe procedures performed in the hospital outpatient setting associated with ICD implants.

CPT Code CPT Code Description

33216 Insertion of a single transvenous electrode, permanent pacemaker or cardioverter-defibrillator

33217 Insertion of 2 transvenous electrodes, permanent pacemaker or cardioverter-defibrillator

33224 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, with attachment to previously placed pacemaker or pacing cardioverter-defibrillator pulse generator (including revision of pocket, removal, insertion and/or replacement of existing generator)

+33225 Insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of pacing cardioverter-defibrillator or pacemaker pulse generator (including upgrade to dual chamber system and pocket revision) (List separately in addition to code for primary procedure)

33230 Insertion of pacing cardioverter-defibrillator pulse generator only; with existing dual leads

33231 Insertion of pacing cardioverter-defibrillator pulse generator only; with existing multiple leads

33240 Insertion of pacing cardioverter-defibrillator pulse generator only; with existing single lead

33241 Removal of pacing cardioverter-defibrillator pulse generator only

33249 Insertion or replacement of permanent pacing cardioverter-defibrillator system with transvenous lead(s), single or dual chamber

33262 Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; single lead system

33263 Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; dual lead system

33264 Removal of pacing cardioverter-defibrillator pulse generator with replacement of pacing cardioverter-defibrillator pulse generator; multiple lead system

+ Add-on code

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CODING FOR ICD THERAPY, continued

Hospital Outpatient HCPCS (C-Codes)Use of C-CodesFor services performed in an outpatient setting, hospitals must submit HCPCS (Healthcare Common Procedure Coding System) Level II C-Codes to identify the device implanted, in addition to the CPT/HCPCS codes for the implantation procedures. CMS implemented Procedure to Device edits effective January 2005 and Device to Procedure edits effective January 2007.

The following C-Codes relate to the implantation of an ICD. Depending on the type of ICD implanted and the specific components, one or a combination of the following codes may be appropriate:

HCPCS Code

(C-Codes)HCPCS Code Description

C1721 Cardioverter-defibrillator, dual chamber (implantable)

C1722 Cardioverter-defibrillator, single chamber (implantable)

C1777 Lead, cardioverter-defibrillator, endocardial single coil (implantable)

C1779 Lead, pacemaker, transvenous VDD single pass (implantable)

C1882 Cardioverter-defibrillator, other than single or dual chamber (implantable)

C1895 Lead, cardioverter-defibrillator, endocardial dual coil (implantable)

C1896 Lead, cardioverter-defibrillator, other than endocardial single or dual coil (implantable)

C1898 Lead, pacemaker, other than transvenous VDD single pass

C1899 Lead, pacemaker-cardioverter-defibrillator combination (implantable)

C1900 Lead, left ventricular coronary venous system

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CODING FOR ICD THERAPY, continued

ICD-9-CM Diagnosis Codes

Secondary Prevention Patients Secondary prevention patients receive an ICD for documented arrhythmias or because they have survived an episode of sudden cardiac arrest. Medicare classifies the codes listed below as being associated with secondary prevention; Medicare transmittal 2005 dated July 23, 2010.6

ICD-9-CMDiagnosis

Code

ICD-9-CMDiagnosis Code Description

427.1 Ventricular tachycardia (Paroxysmal)

427.41 Ventricular fibrillation

427.42 Ventricular flutter

427.5 Cardiac arrest

427.9 Cardiac dysrhythmia, unspecified

Primary Prevention PatientsRefer to the 20.4 Implantable Automatic Defibrillators, Medicare National Coverage when selecting the applicable diagnosis code for a primary prevention patient.

Cardiomyopathy and Ischemic Patients ICD-9-CM has one diagnosis code for ischemic cardiomyopathy, and this code is also used when the diagnosis is ischemic congestive cardiomyopathy.

ICD-9-CMDiagnosis

Code

ICD-9-CMDiagnosis Code Description

414.8 Other specified forms of chronic ischemic heart disease

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CODING FOR ICD THERAPY, continued

Nonischemic Cardiomyopathy: The four nonischemic cardiomyopathy codes are as follows:

ICD-9-CMDiagnosis

Code

ICD-9-CMDiagnosis Code Description

425.1 Hypertrophic cardiomyopathy

425.11 Hypertrophic obstructive cardiomyopathy

425.18 Other hypertrophic cardiomyopathy

425.4 Other primary cardiomyopathies

Prior Myocardial Infarction The ICD-9-CM diagnosis codes for myocardial infarction vary depending on when the MI occurred and whether it still presents symptoms. The myocardial infarction codes in the 410 series indicate an MI that occurred more recently than 8 weeks ago.

For patients who had an MI more than 8 weeks ago, codes 412 or 414.8 can be used. Code 412 is for a healed MI that is currently presenting no symptoms. If the MI occurred more than 8 weeks ago and is no longer acute but is still symptomatic, and the patient is out of the initial episode of care, code 414.8 is used.

Note that the presence of the prior myocardial infarction cannot be assumed by the coder from ECGs or other studies without confirmation in the primary physician documentation. It is essential that physicians document the presence of the prior myocardial infarction clearly.

The following diagnosis codes indicate a myocardial infarction:

ICD-9-CMDiagnosis

Code

ICD-9-CMDiagnosis Code Description

410.00-410.92

Acute myocardial infarction

412 Old myocardial infarction

414.8 Other specified forms of chronic ischemic heart disease

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CODING FOR ICD THERAPY, continued

QRS Duration, Wide and NarrowICD-9-CM does not have a specific code for undiagnosed variations or abnormalities in QRS duration, such as prolonged QT interval on electrocardiogram so this is shown with a general code:

ICD-9-CMDiagnosis

Code

ICD-9-CMDiagnosis Code Description

794.31 Abnormal electrocardiogram (ECG, EKG)

If the patient has a documented diagnosis of Long QT syndrome, this is reported with a specific code:

ICD-9-CMDiagnosis

Code

ICD-9-CMDiagnosis Code Description

426.82 Long QT syndrome

Physician DocumentationPhysician documentation should include specific information about the patient’s heart failure to ensure that the acuity of the patient is recognized. For hospital inpatients, physician documentation for MS-DRGs (Medicare Severity Diagnosis Related Groups) is critical. All primary and secondary diagnoses must be clearly identified in the patient’s record to facilitate appropriate payment.

Heart Failure as a CC (Complication or Comorbidity) or MCC (Major Complication or Comorbidity)Under the MS-DRG system, heart failure can be considered both a chronic and acute condition. Documentation about the specific type of heart failure is critical to determine if the condition is considered a CC or an MCC.

For heart failure to be considered a CC, it must be specified as: • Left heart • Systolic, diastolic, or combined systolic and diastolic

For heart failure to be considered an MCC, it must be specified as: • Acute

or • Acute on chronic

Heart failure diagnosis codes must be explicitly documented by the physician; it cannot be assumed by the coder on the basis of the ejection fraction. Non-diagnostic and non-specific terms such as “low ejection fraction” and “ventricular dysfunction” should also be avoided. Low ejection fraction is a characteristic of heart failure, and it is essential that physicians document the diagnosis clearly.

The following table identifies heart failure diagnosis codes and Medicare’s classification on whether the diagnosis code qualifies as a CC, MCC, or does not qualify.

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CC: Complication or Comorbidity MCC: Major Complication or Comorbidity

CODING FOR ICD THERAPY, continuedHeart Failure

ICD-9-CMDiagnosis

Code

ICD-9-CMDiagnosis Code Description

Medicare Classification7

398.91 Rheumatic heart failure (congestive) CC

402.01 Malignant hypertensive heart disease with heart failure CC

402.11 Benign hypertensive heart disease with heart failure Not a CC

402.91 Hypertensive heart disease, unspecified, with heart failure Not a CC

404.01Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified

CC

404.03Hypertensive heart and chronic kidney disease, malignant, with heart failure and with chronic kidney disease stage V or end stage renal disease

CC

404.11Hypertensive heart and chronic kidney disease, benign, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified

CC

404.13Hypertensive heart and chronic kidney disease, benign, with heart failure and chronic kidney disease stage V or end stage renal disease

CC

404.91Hypertensive heart and chronic kidney disease, unspecified, with heart failure and with chronic kidney disease stage I through stage IV, or unspecified

CC

404.93Hypertensive heart and chronic kidney disease, unspecified, with heart failure and chronic kidney disease stage V or end stage renal disease

CC

428.0 Congestive heart failure, unspecified Not a CC

428.1 Left heart failure CC

428.20 Systolic heart failure, unspecified CC

428.21 Acute systolic heart failure MCC

428.22 Chronic systolic heart failure CC

428.23 Acute on chronic systolic heart failure MCC

428.30 Diastolic heart failure, unspecified CC

428.31 Acute diastolic heart failure MCC

428.32 Chronic diastolic heart failure CC

428.33 Acute on chronic diastolic heart failure MCC

428.40 Combined systolic and diastolic heart failure, unspecified CC

428.41 Acute combined systolic and diastolic heart failure MCC

428.42 Chronic combined systolic and diastolic heart failure CC

428.43 Acute on chronic combined systolic and diastolic heart failure MCC

428.9 Unspecified heart failure Not a CC

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CODING FOR ICD THERAPY, continued

Q0 Modifier As discussed on Page 2, Primary Prevention patients have indications under MADIT-II and SCD-HeFT, which should be reflected by diagnosis codes on the claim. The claim should reflect the primary prevention diagnosis code that supports primary prevention and must include the Q0 modifier with the implant CPT code; this is applicable for hospital outpatients and physician claims. The Medicare transmittal clarifies that if any of the following codes are included on the patient claim, appending the Q0 modifier is not required.6 Refer to the Frequently Asked Questions section for a question about the Q0 modifier.

ICD-9-CMDiagnosis

Code

ICD-9-CMDiagnosis Code Description

427.1 Ventricular tachycardia (Paroxysmal)

427.41 Ventricular fibrillation

427.42 Ventricular flutter

427.5 Cardiac arrest

996.04 Mechanical complication of cardiac device, implant, and draft, due to automatic implantable cardiac defibrillator

V12.53 Personal history of sudden cardiac arrest

V53.32 Fitting and adjustment of other device, automatic implantable cardiac defibrillator

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Inpatient Hospital MS-DRGs for ICD TherapyWhen Medicare deems the ICD or CRT-D procedure to be reasonable and necessary for the inpatient admission, the MS-DRG (Medicare Severity Diagnosis Related Group) assignment may be:

MS-DRG Description

MS-DRG 222Cardiac defibrillator implant with cardiac catheterization with acute myocardial infarction/heart failure/shock with MCC*

MS-DRG 223Cardiac defibrillator implant with cardiac catheterization with acute myocardial infarction/heart failure/shock without MCC*

MS-DRG 224Cardiac defibrillator implant with cardiac catheterization without acute myocardial infarction/heart failure/shock with MCC*

MS-DRG 225Cardiac defibrillator implant with cardiac catheterization without acute myocardial infarction/heart failure/shock without MCC*

MS-DRG 226 Cardiac defibrillator implant without cardiac catheterization with MCC*

MS-DRG 227 Cardiac defibrillator implant without cardiac catheterization without MCC*

MS-DRG 245 Automatic implantable cardiac defibrillator generator procedures

MS-DRG 265 Automatic implantable cardiac defibrillator lead procedures

* MCC = Major Complication or Comorbidity

ICD Generator Replacement (MS-DRG 245)

ICD-9-CMProcedure

Code

ICD-9-CMProcedure Code Description

00.54 Implantation or replacement of cardiac resynchronization defibrillator pulse generator device only [CRT-D]

37.96 Implantation of automatic cardioverter-defibrillator pulse generator only37.98 Replacement of automatic cardioverter-defibrillator pulse generator only

ICD Lead Replacement (MS-DRG 265)

ICD-9-CMProcedure

Code

ICD-9-CMProcedure Code Description

00.52 Implantation or replacement of transvenous lead [electrode] into left ventricular coronary venous system

37.95 Implantation of automatic cardioverter-defibrillator lead(s) only37.97 Replacement of automatic cardioverter-defibrillator lead(s) only

Inpatient Hospital

MS-D

RGs for

ICD Therapy

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Medicare ICD Implant RegistryRegistry participation is mandatory to obtain Medicare coverage for both inpatient and outpatient ICD services for primary prevention patients. Other trials or registries not previously mentioned may submit information about their data collection to the Centers for Medicare and Medicaid Services (CMS) to determine if the data collection requirement is satisfied. For purposes of this coverage decision, CMS will determine whether specific registries or clinical trials meet these criteria.

Patients who are enrolled in an FDA-approved Category B Investigational Device Exemption (IDE) clinical trial or a trial receiving coverage under the Medicare Routine Costs in Clinical Trials policy do not need to have their data submitted to this registry.

The ICD registry is a collaboration between the American College of Cardiology Foundation® and the Heart Rhythm SocietySM, and is formally referred to as the American College of Cardiology’s National Cardiovascular Data Registry’s (ACC-NCDR) ICD Registry™. The purpose of the registry is to meet Medicare’s data requirements.

This registry measures: a) Patient demographics, provider and facility characteristicsb) Device type and characteristicsc) Adverse event rates prior to hospital discharged) Compliance with ACC/AHA/HRS Clinical Guidelines recommendations, and more

Hospitals can choose to enter only Medicare primary prevention patients or all ICD patients that includes primary and secondary patients for both Medicare and non-Medicare patients. It is also very important to remember that Medicare requires the Q0 modifier to be appended to the ICD procedure code for primary prevention patients.6

For Premier Implanting Centers only, on April 1, 2010, the ICD Registry is expanding to:• Capture atrial, ventricular, defibrillator, and left-heart lead data at the time of implant, revision,

replacement, or surgical abandonment• Monitor and report pediatric ICD implantation data to expand the knowledge base for an important

patient population with unique needs at implantation• ICD/CRT-D generators for primary and secondary prevention• Update key quality indicators and align its data set more closely with current guidelines

More information can be found at http://ncdr.com or by calling the American College of Cardiology at 1 (800) 257-4737 to speak with an NCDR team member.

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Frequently Asked QuestionsAnswers to Frequently Asked Questions about CoverageDoes Medicare grant prior authorization for services?No. Medicare does not typically require or grant prior authorization for services. Please contact your local Medicare contractor when you have questions on Medicare coverage. Medicare’s website address is: http://www.cms.gov.

How do non-Medicare payers determine coverage for ICD implants?Non-Medicare payers typically determine coverage through the prior authorization process. Contact the patient’s payer to determine how you should proceed.

Have there been any written changes to Medicare’s covered indications since January 27, 2005?No, the National Coverage Determination (NCD) has not changed. However, as mentioned on page 3, patients with nonischemic dilated cardiomyopathy (NICDM) > 3 months, NYHA Class II and III heart failure, and measured LVEF ≤ 35% will be covered as a result of the ACC-NCDR registry.

Does Medicare cover ICD therapy for the treatment of atrial fibrillation in patients who do not have a corresponding ventricular indication?No. As of October 1, 2003, Medicare coverage is not available for ICD therapy for the treatment of atrial fibrillation in patients who do not have a corresponding ventricular indication, unless the patients are receiving ICD therapy under category B IDE trial (42 CFR §405.201) or the CMS routine clinical trials policy (CIM 30-1, NCD 130.1).

Are there national CMS QRS requirements for NYHA Class IV heart failure CRT-D patients?No, but Medicare local contractors may have developed local coverage decisions for cardiac resynchronization therapy defibrillators (CRT-D). Some of these local coverage decisions (LCDs) may require a strict adherence for FDA labeling (e.g., patients must have a QRS duration > 120 ms or 130 ms, etc.) in order for coverage to be granted. Contact your local Medicare contractor for more information regarding these and other policy requirements. Local Medicare coverage can be researched at: http://www.cms.gov/medicare-coverage-database/overview-and-quick-search.aspx.

Who must report the Q0 (zero) modifier?Physicians must report the Q0 modifier on Medicare claims submitted on or after April 1, 2005 for primary prevention patients. The Q0 modifier should be appended to the primary procedure code describing the service. This modifier is also applicable to Medicare Hospital Outpatient claims (OPPS) and has been since April 1, 2005. The Q0 modifier is not required for secondary prevention diagnosis codes.6

What are the documentation requirements for replacing ICDs? The Medicare NCD does not discuss coverage criteria for replacing an ICD generator. The Department of Justice Resolution Model released to hospitals on August 30, 2012 includes information regarding device replacements on pages 8-9.8

Frequently Asked

Questions

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FREQUENTLY ASKED QUESTIONS, continuedWhat are the 4 NYHA (New York Heart Association) functional classifications? The NYHA functional capacity is an estimation of what a patient’s heart will allow the patient to do. The definitions of NYHA I through IV are as follows:

NYHA I: Patients with cardiac disease but resulting in no limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain.

NYHA II: Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain.

NYHA III: Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain.

NYHA IV: Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort increases.

Source: http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure_UCM_306328_Article.jsp

Do secondary diagnosis codes make a difference in DRG assignment?Yes. With the MS-DRG payment structure, secondary diagnoses codes can affect the DRG assignment. The secondary diagnosis will determine if the patient has a major complication or comorbidity (MCC).

Can certain CC or MCC codes be excluded for MS-DRG assignment in particular situations?Yes. Certain MCC codes will not be applicable when submitted with particular CC (Complication or Comorbidity) principal diagnosis codes.9 Some MCC codes are only valid if the patient is discharged alive. This list includes9:

427.41 427.5 785.51 785.59 799.1Ventricular fibrillation

Cardiac arrest Cardiogenic shock Other shock Respiratory arrest

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For additional information, please contact:

CRDMeconomics and health

policy

Visit our website:www.Medtronic.com/crdmreimbursement

Call our Coding Hotline:1 (866) 877-4102

Email us:[email protected]

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References

1 The history of Medicare coverage for implantable automatic defibrillators can be found at: http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=110&ncdver=3&bc=BAAAgAAAAAAA&.

2 Bardy GH, Lee KL, Mark DB, et al, for the Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart failure [published correction appears in N Engl J Med. May 19, 2005;352(20):2146]. N Engl J Med. January 20, 2005;352(3):225-237.

3 Moss AJ, Zareba W, Hall WJ, et al, for the Multicenter Automatic Defibrillator Implantation Trial II Investigators. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. March 21, 2002;346(12):877-883.

4 Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined – a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. J Am Coll Cardiol. September 2000;36(3):959-969.

Criteria for acute, evolving, or recent MI: Either one of the following criteria satisfies the diagnosis for an acute, evolving, or recent MI: 1) Typical rise and gradual fall (troponin) or more rapid rise and fall (CK-MB) of biochemical markers of myocardial necrosis with at least one of the following:

a) Ischemic symptoms b) Development of pathologic Q waves on the ECG c) ECG changes indicative of ischemia (ST segment elevation or depression) or d) Coronary artery intervention (e.g., coronary angioplasty)

2) Pathologic findings of an acute MI Criteria for established MI: Any one of the following criteria satisfies the diagnosis for established MI: 1) Development of new pathologic Q waves on serial ECGs. The patient may or may not remember previous symptoms. Biochemical markers of myocardial

necrosis may have normalized, depending on the length of time that has passed since the infarct developed. 2) Pathologic findings of a healed or healing MI.

5 CPT copyright 2013 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. 6 Pub 100-04 Medicare Claims Processing (CMS), Transmittal 2005 dated July 23, 2010, Change Request 7015 is available at:

https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R2005CP.pdf. 7 Medicare’s MCC (Table 6I) and CC (Table 6J) for the selected fiscal year are available at:

https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/index.html. 8 Department of Justice ICD Investigation Medical Review Guidelines/Resolution Model, Section 3, pages 8-9. 9 Medicare Severity Diagnosis Related Groups (MS-DRGs) Definitions Manual 3M Health Information Systems.

www.medtronic.com

World HeadquartersMedtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879 Medtronic USA, Inc. Toll-free: 1 (800) 328-2518(24-hour technical support for physicians and medical professionals)