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Medicare: Lung
Volume Reduction Surgery
CMS News Release
November 7, 2003
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The Centers for Medicare & Medicaid Services (CMS) has revised its
National Coverage Decision (NCD) to reflect an expansion in Medicare
coverage for lung volume reduction surgery (LVRS). Information can be
found in the online CMS Manual, Publication 100-03, Section 240.1.
For services performed on or after January 1, 2004, Medicare
coverage for lung volume reduction surgery is expanded to include
patients who are: (1) Non high-risk and present with severe,
upper-lobe emphysema; or, (2) Non high-risk and present with severe,
non upper-lobe emphysema with low exercise capacity. Patients must
also meet all other criteria outlined in the National Coverage
Decision. For your convenience, we are printing the NCD in its
entirety below.
In addition to the expanded coverage for lung volume reduction
surgery (LVRS), Medicare will pay providers on a fee-for-service basis
for the new coverage when the beneficiary is enrolled in a risk
Medicare+Choice (M+C) plan. Payment will be made in this manner until
the capitation rates for M+C organizations are adjusted to account for
the expanded coverage. Because the fee-for-service claims processing
system automatically excludes claim services provided for risk M+C
beneficiaries except in certain circumstances for which editing has
been created, special billing instructions are required. These
instructions are listed below.
Coverage Guidelines
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.
A.Covered Indications
Medicare-covered LVRS approaches are limited to bilateral excision
of a damaged lung with stapling performed via median sternotomy or
video-assisted thoracoscopic surgery.
1. National Emphysema Treatment Trial (NETT) participants
(effective for services performed on or after August 11, 1997):
Medicare provides coverage to those beneficiaries who are
participating in the NETT trial for all services integral to the study
and for which the Medicare statute does not prohibit coverage.
2. Medicare will only consider LVRS reasonable and necessary
when all of the following requirements are met (effective for services
performed on or after January 1, 2004):
a. The patient satisfies all the criteria outlined below:
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Assessment |
Criteria |
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History and physical examination |
Consistent with emphysema |
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BMI, ≤ 31.1 kg/m2 (men) or ≤ 32.3 kg/m2
(women) |
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Stable with ≤20 mg prednisone (or equivalent) qd |
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Radiographic |
High Resolution Computer Tomography (HRCT) scan evidence of
bilateral emphysema |
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Pulmonary function (pre-rehabilitation) |
Forced expiratory volume in one second (FEV1) ≤ 45%
predicted (≥ 15% predicted if age ≥70 years) |
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Total lung capacity (TLC) ≥100% predicted post-bronchodilator |
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Residual volume (RV) ≥150% predicted post-bronchodilator |
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Arterial blood gas level (pre-rehabilitation) |
PCO2, ≤ 60 mm Hg (PCO2, ≤ 55 mm Hg if 1-mile
above sea level) |
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PO2, ≥ 45 mm Hg on room air (PO2, ≥ 30 mm Hg
if 1-mile above sea level) |
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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) |
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Surgical assessment |
Approval for surgery by pulmonary physician, thoracic surgeon, and
anesthesiologist post-rehabilitation |
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Exercise |
Post-rehabilitation 6-min walk of ≥140 m; able to complete 3 min
unloaded pedaling in exercise tolerance test (pre- and
post-rehabilitation) |
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Consent |
Signed consents for screening and rehabilitation |
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Smoking |
Plasma cotinine level ≤ 13.7 ng/mL (or arterial carboxyhemoglobin
≤ 2.5% if using nicotine products) |
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Nonsmoking for 4 months prior to initial interview and throughout
evaluation for surgery |
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Preoperative diagnostic and therapeutic program adherence |
Must complete assessment for and program of preoperative services
in preparation for surgery |
b. 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.
c. The surgery must be performed at facilities that were identified
by the National Heart, Lung, and Blood Institute to meet the
thresholds for participation in the NETT, and at sites that
have been approved by Medicare as lung transplant facilities. These
facilities are listed on our Web site at
www.cms.hhs.gov/coverage/lvrsfacility.pdf. The CMS is
currently working to develop accreditation standards for facilities to
perform LVRS and when implemented, will consider LVRS to be reasonable
and necessary only at accredited facilities.
d. 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.
B. Noncovered Indications
1. LVRS is not covered in any of the following clinical
circumstances:
- Patient characteristics carry a high risk for perioperative
morbidity and/or mortality;
- The disease is unsuitable for LVRS;
- 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;
- The patient presents with FEV <= 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
- The patient satisfies the criteria outlined above in section
2(a), 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.
Billing Instructions for Providers Who Render Services to
Managed Care Patients
The following instructions apply to providers who render lung
volume reduction surgery to managed care patients:
 | Providers are encouraged not to submit claims for services
rendered on or after January 1, 2004 through March 31, 2004 because
Medicare will not be able to process the claims until April 5, 2004.
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 | Physicians must use modifier KZ (new coverage not implemented by
managed care) when billing for services rendered on and after
January 1, 2004. |
 | The physician should bill for the appropriate service with
procedure code 32491. |
 | Patients who receive these services must pay any applicable
coinsurance amounts. |
Billing Instructions for Providers Who Render Services to
Fee-for-Service Patients
The following instructions apply to providers who render lung
volume reduction surgery to fee-for-service patients:
 | Claims for these services cannot be billed using modifier KZ.
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 | The physician should bill for the appropriate service with
procedure code 32491. |
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