**

B. Nationally Covered Indications

**

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 (note varying dates for facility criteria in section 3.
below):

**1\. The patient satisfies all the criteria outlined below:**

Assessment | Criteria  
---|---  
  
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) qd  
  
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 mm Hg (PCO2,  55 mm Hg if 1-mile above sea level)  
  
PO2,  45 mm Hg on room air (PO2,  30 mm Hg 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
indicates 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-min walk of  140 m; able to complete 3 min 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  
  
**2\. 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 for women and 40 watts (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.

**3\. 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 [http://www.cms.gov/Medicare/Medicare-
General-
Information/MedicareApprovedFacilitie/04_lvrs.asp#TopOfPage](https://www.cms.gov/Medicare/Medicare-
General-Information/MedicareApprovedFacilitie/Lung-Volume-Reduction-Surgery-
LVRS.html#TopOfPage#TopOfPage).

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.

**C. Nationally Non-covered Indications**

**1\. LVRS is not covered in any of the following clinical circumstances:**

  1. Patient characteristics carry a high risk for perioperative morbidity and/or mortality;
  2. The disease is unsuitable for LVRS;
  3. Medical conditions or other circumstances make it likely that the patient will be unable to complete the preoperative and postoperative pulmonary diagnostic and therapeutic program required for surgery;
  4. The patient presents with FEV1  20% of predicted value, and either homogeneous distribution of emphysema on CT scan, or carbon monoxide diffusing capacity of  20% of predicted value (high-risk group identified October 2001 by the NETT); or
  5. The patient satisfies the criteria outlined above in section B(1), and has severe, non-upper lobe emphysema with high exercise capacity. High exercise capacity is defined as a maximal workload at the completion of the preoperative diagnostic and therapeutic program that is above 25 w for women and 40 w for men (under the measurement conditions for cycle ergometry specified above).

**2\. All other indications for LVRS not otherwise specified remain
noncovered.**

(This NCD last reviewed November 2005.)