L29091-LCD

Automated World Health

Local Coverage Determination (LCD) for Cardiac Output Monitoring by Thoracic Electrical

Bioimpedance (L29091)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29091

LCD Title Cardiac Output Monitoring by Thoracic Electrical Bioimpedance

Contractor's Determination Number 93701

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS 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. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 10/01/2011 Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

CMS Manual System, Pub. 100-03 Medicare National Coverage Determinations, Chapter 1, section 20-16

Indications and Limitations of Coverage and/or Medical Necessity

Cardiac output monitoring using electrical bioimpedance, a form of plethysmography, is covered by Medicare effective for services furnished on or after July 1, 1999.

These devices utilize electrical bioimpedance to noninvasively produce hemodynamic measurements of cardiac output, specifically stroke volume, contractility, systemic vascular resistance, and thoracic fluid content. These devices are covered for the following indications:

• Differentiation of cardiogenic from pulmonary causes of acute dyspnea when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.

• Optimization of atrioventricular (A/V) interval for patients with A/V sequential cardiac pacemakers when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.

• Monitoring of continuous inotropic therapy for patients with terminal congestive heart failure, when those patients have chosen to die with comfort at home, or for patients waiting at home for a heart transplant.

• Evaluation for rejection in patients with a heart transplant as a predetermined alternative to a myocardial biopsy. Medical necessity must be documented should a biopsy be performed after TEB.

• Optimization of fluid management in patients with congestive heart failure when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.

• Management of drug-resistant hypertension. Drug resistant hypertension is defined as failure to achieve goal BP in patients who are adhering to full doses of an appropriate three-drug regimen that includes a diuretic.

The following are examples of appropriate clinical indications for which Medicare will consider the assessment of cardiac output by electrical bioimpedance medically reasonable and necessary:

• For patients with structural heart disease (with an ejection fraction £ 40%) associated with the development of congestive heart failure (e.g., valvular and congenital, post myocardial infarction, rheumatic heart disease);

• For patients with inflammatory heart disease (with an ejection fraction £ 40%) associated with the development of congestive heart failure (e.g., myocarditis and cardiomyopathy, pericarditis and constrictive pericardial scarring, rheumatic heart disease);

• For patients with ischemic heart disease (with an ejection fraction £ 40%) associated with the development of congestive heart failure (e.g., post myocardial infarction, ischemic cardiomyopathy, ischemic mitral valve or left ventricular dysfunction);

• For patients with cardiac disease resulting in congestive heart failure with normal left ventricular function (e.g., diastolic dysfunction, restrictive cardiomyopathy/infiltrative such as amyloidosis or cancer of the heart);

• For patients with pulmonary disease associated with congestive heart failure (e.g., cor pulmonale and the need to distinguish between pulmonary and cardiac disease as the cause, pulmonary hypertension);

• For acute conditions for which the patient might present to an outpatient setting and in which a decision regarding intervention is necessary (e.g., pericardial effusion with possible tamponade, myocardial infarction, cardiac trauma);

• For patients with recent pacemaker implants who demonstrate clinical manifestations of unexplained fatigue, symptomatic hypotension, or congestive heart failure;

• For the titration of therapeutic agents in the setting of symptomatic congestive heart failure;

• For acute heart rejection during outpatient follow-up of heart transplant patients (as a supplement to invasive endomyocardial biopsy); and/or

• For patients with acute/chronic renal failure or end stage renal disease/dialysis who demonstrate clinical manifestations of unexplained shortness of breath, unexplained reduced access flow, symptomatic hypotension/hypertension.

LIMITATIONS OF COVERAGE

Cardiac output by electrical bioimpedance is not covered for the following indications:

• Monitoring of patients with proven or suspected disease involving severe regurgitation of the aorta;

• Patients with minute ventilation (MV) sensor function pacemakers (since the device may adversely affect the functioning of that type of pacemaker);

• Cardiac bypass patients while on a cardiopulmonary bypass machine (since the device does not render accurate measurements under this circumstance); and/or

• The use of electrical bioimpedance for the routine assessment of hypertensive patients.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

93701 BIOIMPEDANCE-DERIVED PHYSIOLOGIC CARDIOVASCULAR ANALYSIS

ICD-9 Codes that Support Medical Necessity

391.0 - 391.9 ACUTE RHEUMATIC PERICARDITIS - ACUTE RHEUMATIC HEART DISEASE UNSPECIFIED

394.0 - 394.9 MITRAL STENOSIS - OTHER AND UNSPECIFIED MITRAL VALVE DISEASES

397.0 - 397.9 DISEASES OF TRICUSPID VALVE - RHEUMATIC DISEASES OF ENDOCARDIUM VALVE UNSPECIFIED

398.90 RHEUMATIC HEART DISEASE UNSPECIFIED

398.91 RHEUMATIC HEART FAILURE (CONGESTIVE)

401.0 MALIGNANT ESSENTIAL HYPERTENSION

401.9 UNSPECIFIED ESSENTIAL HYPERTENSION

402.00 -402.01 MALIGNANT HYPERTENSIVE HEART DISEASE WITHOUT HEART FAILURE - MALIGNANT HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

402.11 BENIGN HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

402.91 UNSPECIFIED HYPERTENSIVE HEART DISEASE WITH HEART FAILURE

403.00 - 403.01 HYPERTENSIVE CHRONIC KIDNEY DISEASE, MALIGNANT, WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED - HYPERTENSIVE CHRONIC KIDNEY DISEASE, MALIGNANT, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

403.11 HYPERTENSIVE CHRONIC KIDNEY DISEASE, BENIGN, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

403.91 HYPERTENSIVE CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITHOUT HEART

404.00 - 404.03 FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED - HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, MALIGNANT, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.11 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED

404.12 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.13 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, BENIGN, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART

404.91 FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE I THROUGH STAGE IV, OR UNSPECIFIED

404.92 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITHOUT HEART FAILURE AND WITH CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

404.93 HYPERTENSIVE HEART AND CHRONIC KIDNEY DISEASE, UNSPECIFIED, WITH HEART FAILURE AND CHRONIC KIDNEY DISEASE STAGE V OR END STAGE RENAL DISEASE

405.01 - 405.09 MALIGNANT RENOVASCULAR HYPERTENSION - OTHER MALIGNANT SECONDARY HYPERTENSION

405.91 - 405.99 UNSPECIFIED RENOVASCULAR HYPERTENSION - OTHER UNSPECIFIED SECONDARY HYPERTENSION

410.00 - 410.92 ACUTE MYOCARDIAL INFARCTION OF ANTEROLATERAL WALL EPISODE OF CARE UNSPECIFIED - ACUTE MYOCARDIAL INFARCTION OF UNSPECIFIED SITE SUBSEQUENT EPISODE OF CARE

411.0 - 411.89 POSTMYOCARDIAL INFARCTION SYNDROME - OTHER ACUTE AND SUBACUTE FORMS OF ISCHEMIC HEART DISEASE OTHER

413.0 - 413.9 ANGINA DECUBITUS - OTHER AND UNSPECIFIED ANGINA PECTORIS

414.00 - 414.07 CORONARY ATHEROSCLEROSIS OF UNSPECIFIED TYPE OF VESSEL NATIVE OR GRAFT - CORONARY ATHEROSCLEROSIS OF BYPASS GRAFT (ARTERY) (VEIN) OF TRANSPLANTED HEART

414.10 - 414.19 ANEURYSM OF HEART (WALL) - OTHER ANEURYSM OF HEART

414.4 CORONARY ATHEROSCLEROSIS DUE TO CALCIFIED CORONARY LESION

414.8 OTHER SPECIFIED FORMS OF CHRONIC ISCHEMIC HEART DISEASE

415.0 - 415.19 ACUTE COR PULMONALE - OTHER PULMONARY EMBOLISM AND INFARCTION

420.0 - 420.99 ACUTE PERICARDITIS IN DISEASES CLASSIFIED ELSEWHERE - OTHER ACUTE PERICARDITIS

421.0 - 421.9 ACUTE AND SUBACUTE BACTERIAL ENDOCARDITIS - ACUTE ENDOCARDITIS UNSPECIFIED

422.0 - 422.99 ACUTE MYOCARDITIS IN DISEASES CLASSIFIED ELSEWHERE - OTHER ACUTE MYOCARDITIS

423.0 - 423.9 HEMOPERICARDIUM - UNSPECIFIED DISEASE OF PERICARDIUM

424.0 MITRAL VALVE DISORDERS

424.2 TRICUSPID VALVE DISORDERS SPECIFIED AS NONRHEUMATIC

424.3 PULMONARY VALVE DISORDERS

424.90 - 424.99 ENDOCARDITIS VALVE UNSPECIFIED UNSPECIFIED CAUSE - OTHER ENDOCARDITIS VALVE UNSPECIFIED

425.0 - 425.8 ENDOMYOCARDIAL FIBROSIS - CARDIOMYOPATHY IN OTHER DISEASES CLASSIFIED ELSEWHERE

428.0 - 428.9 CONGESTIVE HEART FAILURE UNSPECIFIED - HEART FAILURE UNSPECIFIED

429.3 CARDIOMEGALY

429.4 FUNCTIONAL DISTURBANCES FOLLOWING CARDIAC SURGERY

429.83 TAKOTSUBO SYNDROME

430 SUBARACHNOID HEMORRHAGE

518.4 ACUTE EDEMA OF LUNG UNSPECIFIED

518.7 TRANSFUSION RELATED ACUTE LUNG INJURY (TRALI)

786.05 SHORTNESS OF BREATH

996.83 COMPLICATIONS OF TRANSPLANTED HEART V42.1* HEART REPLACED BY TRANSPLANT

V53.31 FITTING AND ADJUSTMENT OF CARDIAC PACEMAKER

V53.32 FITTING AND ADJUSTMENT OF AUTOMATIC IMPLANTABLE CARDIAC DEFIBRILLATOR

* According to the ICD-9-CM book, diagnosis code V42.1 is a secondary diagnosis code and should not be billed as the primary diagnosis.

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation (e.g., office/progress notes) maintained by the ordering/referring physician must indicate the medical necessity for assessment of cardiac output by electrical bioimpedance.

Additionally, a copy of the measurements acquired through the use of the electrical bioimpedance device, with the physician's signature, must be maintained in the medical record.

Appendices

Utilization Guidelines The frequency of measurements of cardiac output monitoring by thoracic electrical bioimpedance which Medicare will consider medically reasonable and necessary will be based on the purpose for which the measurement is obtained. The following are examples of categories of use and the general guidelines regarding measurement frequency:

Diagnostic - Frequency of use for diagnostic purposes will apply to patients in whom congestive heart failure is evident, yet its etiology is unclear. An initial measurement may be sufficient, with infrequent follow-up assessments. Examples include (but are not limited to):

• A patient with respiratory failure and the need to distinguish the presence of a cardiac component of the illness.

• Pericardial effusion of uncertain hemodynamic significance.

• Suspected diastolic dysfunction or the presence of congestive heart failure in the setting of normal left ventricular function.

Titration of Therapeutic Agents - Frequency of use for monitoring therapeutic drug response will require more frequent measurements, and may vary. The frequency at which titration of the therapeutic agents is considered medically reasonable and necessary will be based on whether the drug is approved for use in a regimented fashion. Examples include (but are not limited to):

• Medication adjustments in patients with refractory congestive heart failure due to either systolic or diastolic dysfunction (especially patients with a left ventricular ejection fraction < 40%).

• Medication adjustments for patients receiving a hemodynamically active anti-hypertensive medication for which a regimented or standardized approach exists. Weekly assessments may be considered reasonable in patients undergoing titration of medications for which there is a regimented approach to titration (e.g., carvedilol). Because individual tolerance is quite variable and the side effects make it difficult to ascertain whether the patient is realizing maximal benefit, knowledge of the cardiac output as an objective measure would assist the practitioner in decisions regarding titration. ACE inhibitors may also fall into this category, yet a maximum of 4 to 6 weekly measurements may be sufficient, with subsequent measurements at 1-3 month intervals.

Monitoring - Frequency of use for monitoring of a patient for a period of clinical assessment should be thought of as a single use. Examples include:

• To determine the effect of changes in pacemaker programming where several adjustments might be made during a single visit to optimize pacemaker function.

• Hemodynamic monitoring during a surgical procedure that takes place in the physician's office.

NOTE: Measurement of cardiac output monitoring by thoracic electrical bioimpedance is not considered medically reasonable and necessary upon each visit or for each change in the patient's medication regimen.

Sources of Information and Basis for Decision

Drazner MH, et al. Comparison of impedance cardiography with invasive hemodynamic measurements in patients with heart failure secondary to ischemia of nonischemic cardiomyopathy. Amer J Cardiol 2002 Apr 15;18(8):993- 5.

Gilbert J, Lazio L.; Managing congestive heart failure with thoracic electrical bioimpedance.,: AACN Clin Issues 1999 Aug;10(3):400-5

Hartleb M, Rudzki K, Waluga M, Janusz M, Karpel E.; Usefulness of thoracic electrical bioimpedance in detection of ejection fraction changes., J Physiol Pharmacol 2000 Mar;51(1):151-9

Hirschl MM, Kittler H, Woisetschlager C, Siostrzonek P, Staudinger T, Kofler J, Oschatz E, Bur A, Gwechenberger M, Laggner AN.; Simultaneous comparison of thoracic bioimpedance and arterial pulse waveform-derived cardiac output with thermodilution measurement., Crit Care Med 2000 Jun;28(6):1798-802

Imhoff M, et al. Noninvasive whole-body electrical bioimpedance cardiac output and invasive thermodilution cardiac output in high-risk surgical patients. Crit Care Med 2000 Aug; 28(8):2812-8.

Jordan HS, Ioannidis JPA, Goudas LC, et al. and the Tufts-New England Medical Center AHRQ Evidence-based Practice Center. Thoracic electrical bioimpedance. EPC Technical Support of the CPTA Technology Assessment Program. Contract No. 290-97-0019, Task Order #10. Rockville, MD: AHRQ; revised November 27, 2002.

Available at: http://www.cms.hhs.gov/mcd/viewtechassess.asp?id=23 . Accessed October 3, 2003.

Kosowsky JM, et al. Assessment of stroke index using impedance cardiography: comparison with traditional vital signs for detection of moderate acute loss of blood in healthy volunteers. Acad Emerg Med 2002 Aug;9(8):775- 80.

Lasater, R.N., MSN, CCRN, M. (1998). The view within: The emerging technology of thoracic electrical bioimpedance. Critical Care Nursing Quarterly, 21 (3), 97-101.

Marrocco, A., Eskin, B., Nashed, A., et al. (1998). Noninvasive bioimpedance monitoring differentiates cardiogenic from pulmonary causes of acute dyspnea in the emergency department. SAEM 1998 Annual Meeting Academic Emergency Medicine, 5 (5), 476-477.

Milzman, D., Hogan, C., Zlindenny, A., et al. (1998). The utility of thoracic impedance to evaluate chest radiograph changes from acute heart failure patients in the emergency department. Journal of Cardiac Failure, 4 (3), Supplement 1.

Nakonezny PA, et al. New ambulatory impedance cardiograph validated against Minnesota Impedance Cardiograph. Psychophysiol 2001 May;38:465-73.

1999 World Health Organization-International Society of Hypertension guidelines for the management of hypertension. Guidelines Subcommittee. Journal of Hypertension, 17 (2), 151-183.

Sageman WS, et al. Equivalence of bioimpedance and thermodilution in measuring cardiac index after cardiac surgery. J Cardiothorac Vas Anesth 2002 Feb;16(1):8-14.

Spiess BD, et al. Comparison of bioimpedance versus thermodilution cardiac output during cardiac surgery; evaluation of a second generation bioimpedance device. J Cardiothorac Vasc Anesth 2001;15(5):567-73.

U.S. Department of Health and Human Services, Center for Medicare and Medicaid Services (CMS). Decision memo for electrical bioimpedance for cardiac output monitoring (CAG-00001R). Medicare Coverage Database. Baltimore, MD: CMS; August 7, 2003. http://www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=23 . Accessed October 3, 2003.

Zaluska W, Jaroszynski A, Bober E, Malecka T, Kozik J, Ksiazek A.; [Measurement of fluid compartments using electrical bioimpedance for assessment of target weight in hemodialysis patients], Przegl Lek 2000;57(12):707- 10

1999 World Health Organization-International Society of Hypertension guidelines for the management of hypertension. Guidelines Subcommittee. Journal of Hypertension, 17 (2), 151-183.

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 01/01/2010

Revision History Number 2

Revision History Explanation Revision Number:2 Start Date of Comment Period:N/A

Start Date of Notice Period:10/01/2011 Revised Effective Date: 10/01/2011

LCR B2011-101

September 2011 Connection

Explanation of Revision: Annual 2012 ICD-9-CM Update. Added diagnosis code 414.4. The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2010 Revised Effective Date: 01/01/2010

LCR B2010 - 014

December 2009 Update

Explanation of Revision: Annual 2010 HCPCS Update. Revised descriptor for CPT code 93701. The effective date of this revision is based on date of service.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29091) replaces LCD L5979 as the policy in notice. This document (L29091) is effective on 02/02/2009.

11/15/2009 - The description for CPT/HCPCS code 93701 was changed in group 1

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

93701 descriptor was changed in Group 1

08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

Reason for Change