L29214-LCD

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Local Coverage Determination (LCD) for Lung Volume Reduction Surgery (L29214)

Contractor Information

Contractor Name First Coast Service Options, Inc.

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29214

LCD Title Lung Volume Reduction Surgery

Contractor's Determination Number 32491

Primary Geographic Jurisdiction Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. 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 01/01/2012

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 administratice 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 Transmittal 27, Change Request 2688

CMS Transmittal 768, Change Request 4149

NCD for Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1)

Indications and Limitations of Coverage and/or Medical Necessity

Lung Volume Reduction Surgery (LVRS) or reduction pneumoplasty, also referred to as lung shaving or lung contouring, is performed on patients with severe emphysema in order to allow the remaining compressed lung to expand, and thus, improve respiratory function.

Effective for services performed on or after January 1, 2004. Medicare will only consider LVRS reasonable and necessary when all of the following requirements are met:

History and Physical Examination: Consistent with emphysema; BMI, <31.1 kg/m2 (men) or < 32.3 kg/m2 (women), Stable with <20 mg prednisone (or equivalent) every day

Radiographic: High Resolution Computer Tomography (HRCT) scan evidence of bilateral emphysema

Pulmonary function (pre-rehabilitation): Forced expiratory volume in one second (FEV1) <45% predicted ( > 15% predicted if age > 70 years), Total lung capacity (TLC) > 100% predicted post-bronchodilator, Residual volume (RV) > 150% predicted post-bronchodilator

Arterial blood gas level (pre-rehabilitation): PCO2 <60 mmHg (PCO2 <55 mmHg if 1-mile above sea level), PO2 > 45 mmHg on room air (PO2 > 30 mmHg if 1-mile above sea level)

Cardiac assessment: Approval for surgery by cardiologist if any of the following are present: Unstable angina; left-ventricular ejection fraction (LVEF) cannot be estimated from the echocardiogram; LVEF <45%; dobutamine- radionuclide cardiac scan indicated coronary artery disease or ventricular dysfunction; arrhythmia (> 5 premature ventricular contractions per minute; cardiac rhythm other than sinus; premature ventricular contractions on EKG at rest)

Surgical assessment: Approval for surgery by pulmonary physician, thoracic surgeon, and anesthesiologist post

-rehabilitation

Exercise: Post-rehabilitation 6-minute walk of > 140 m; able to complete 3 minutes unloaded pedaling in exercise tolerance test (pre- and post-rehabilitation)

Consent: Signed consents for screening and rehabilitation

Smoking: Plasma cotinine level <13.7 ng/mL (or arterial carboxyhemoglobin <2.5% if using nicotine products), Nonsmoking for 4 months prior to initial interview and throughout evaluation for surgery

Preoperative diagnostic and therapeutic program adherence: Must complete assessment for and program of preoperative services in preparation for surgery

In addition, the patient must have:

- Severe upper lobe predominant emphysema (as defined by radiologist assessment of upper lobe predominance on CT scan), or

- Severe non-upper lobe emphysema with low exercise capacity.

Patients with low exercise capacity are those whose maximal exercise capacity is at or below 25 watts (w) for women and 40 w for men after completion of the preoperative therapeutic program in preparation for LVRS. Exercise capacity is measured by incremental, maximal, symptom-limited exercise with a cycle ergometer utilizing 5 or 10 watt/minute ramp on 30% oxygen after 3 minutes of unloaded pedaling.

Effective for services performed on or after November 17, 2005, CMS determines that LVRS is reasonable and necessary when performed at facilities that are:

(1) certified by the Joint Commission on Accreditation of Healthcare Organizations (Joint Commission) under the LVRS Disease Specific Care Certification Program (program standards and requirements as printed in the Joint Commission’s October 25, 2004, Disease Specific Care Certification Program packet); or (2) approved as Medicare lung or heart-lung transplantation hospitals.

In addition, LVRS performed between January 1, 2004, and May 17, 2007, is reasonable and necessary when performed at facilities that: (1) were approved by the National Heart Lung and Blood Institute to participate in the National Emphysema Treatment Trial (NETT); or (2) are approved as Medicare lung or heart-lung transplantation hospitals.

A list of approved facilities and their approval dates will be listed and maintained on the CMS Web site at www.cms.hhs.gov under Medicare – General Information.

The surgery must be preceded and followed by a program of diagnostic and therapeutic services consistent with those provided in the NETT and designed to maximize the patient’s potential to successfully undergo and recover from surgery. The program must include a 6- to 10-week series of at least 16, and no more than 20, preoperative sessions, each lasting a minimum of 2 hours. It must also include at least 6, and no more than 10, postoperative sessions, each lasting a minimum of 2 hours, within 8 to 9 weeks of the LVRS. This program must be consistent with the care plan developed by the treating physician following performance of a comprehensive evaluation of

the patient’s medical, psychosocial and nutritional needs, be consistent with the preoperative and postoperative services provided in the NETT, and arranged, monitored, and performed under the coordination of the facility where the surgery takes place.

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

REMOVAL OF LUNG, OTHER THAN PNEUMONECTOMY; WITH RESECTION-PLICATION OF EMPHYSEMATOUS 32491 LUNG(S) (BULLOUS OR NON-BULLOUS) FOR LUNG VOLUME REDUCTION, STERNAL SPLIT OR

TRANSTHORACIC APPROACH, INCLUDES ANY PLEURAL PROCEDURE, WHEN PERFORMED

ICD-9 Codes that Support Medical Necessity

492.8 OTHER EMPHYSEMA

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

The following documentation must be submitted upon request for LVRS: history and physical examination, HRCT scan, pulmonary function tests (pre-rehabilitation), arterial blood gas levels (pre-rehabilitation), cardiac assessment, surgical assessment, exercise report, consents, smoking evaluation, and evidence of preoperative diagnostic and therapeutic program adherence.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Sources of Information and Basis for Decision CMS Transmittal 27 (Change Request 2688)

CMS Transmittal 768, Change Request 4149

NCD for Lung Volume Reduction Surgery (Reduction Pneumoplasty) (240.1)

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 12/04/2008

Revision History Number 1

Revision History Explanation Revision Number:1 Start Date of Comment Period:N/A

Start Date of Notice Period:01/01/2012 Revised Effective Date: 01/01/2012

LCR B2012-005

December 2011 Connection

Explanation of Revision: Annual 2012 HCPCS Update. Descriptor revised for CPT code 32491. 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 (L29214) replaces LCD L18131 as the policy in notice. This document (L29214) is effective on 02/02/2009.

11/21/2011 - 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:

32491 descriptor was changed in Group 1

Reason for Change