(Medicare National Coverage Determinations Manual)

Continued use of levocarnitine will not be covered if improvement has not been demonstrated within 6 months of initiation of treatment.  All other indications for levocarnitine are noncovered in the ESRD population.   For a patient currently receiving intravenous levocarnitine, Medicare will cover continued treatment if:   Levocarnitine has been administered to treat erythropoietin- resistant anemia (persistent hematocrit <  30 percent with treatment) that has not responded to standard erythropoietin dosage (that which is considered clinically appropriate to treat the particular patient) with iron replacement, and for which other causes have been investigated and adequately treated, or hypotension on hemodialysis that interferes with delivery of the intended dialysis despite application of usual measures deemed appropriate (e.g ., fluid management) and such episodes of hypotension occur during at least 2 dialysis treatments in a 30- day period; and   The patients medical record documents a pre -dialysis plasma free carnitine level < 40 micromol/L prior to the initiation of treatment; or   The treating physician certifies (documents in the medical record) that in his/her judgment, if treatment with the levocarnitine is discontinued, the patients pre -dialysis carnitine level would fall below 40 micromol/L and the patient would have recurrent  erythropoietin- resistant -anemia or intradialytic hypotension.  240 - Respiratory System  (Rev. 1, 10- 03-03)  240.1 - Lung Volume Reduction Surgery (Reduction Pneumoplasty)  (Various Effective Dates Below)  (Rev. 44, Issued:  12- 02-05; Effective:  11 -17-05; Implementation:  03- 02-06)  A.  General   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.  Medicare-covered LVRS approaches are limited to bilateral excision of a damaged lung with stapling performed via median sternotomy or video- assisted thoracoscopic surgery.   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/m 2 (men) or 32.3 kg/m 2 (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 (FEV  1) 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)  PCO  2, 60 mm Hg (PCO  2, 55 mm Hg if 1 -mile above sea level)  PO  2, 45 mm Hg on room air (PO  2, 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 ventri cular 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 Must complete assessment for and program of preoperative services in preparation for surgery  therapeutic program adherence  2.  In addition, the patient must have:  o Severe upper lobe predominant emphysema (as defined by radiologist assessment of upper lobe predominance on CT scan), or   o 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 inc remental, 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 Commissions October 25, 2004, Dise ase 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/coverage/lvrsfacility.pdf . 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:  a.  Patient characteristics carry a high risk for perioperative morbidity and/or mortality;   b.  The disease is unsuitable for LVRS;   c.  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;   d.  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   e.  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.)   240.2 - Home Use of Oxygen  (Rev.11587; Issued: 09- 08-22; Effective: 09 -27-21; Implementation: 01 -03-23)   A. General   When used in the home, oxygen and oxygen equipment can make meaningful contributions to the treatment of patients with both acute and chronic conditions who require the medical gas on either a short - or long- term basis.   B. Nationally Covered Indications   Oxygen therapy and oxygen equipment is covered in the home for acute or chronic conditions, short - or long-  term, when the patient exhibits hypoxemia as defined below.   Initial claims for oxygen therapy for hypoxemic patients must be based on the results of a clinical test that has been ordered and evaluated by the treating practitioner. Such a test is usually in the form of a measurement of the partial pressure of oxygen (PO2) in arterial blood. A measurement of arterial oxygen saturation obtained by ear or pulse oximetry, however, is also acceptable when ordered and evaluated by the treating practitioner and performed under his or her supervision or when performed by a qualified provider or supplier of laboratory services. A durable medical equipment (DME) supplier is not considered a qualified provider or supplier of laboratory services for purposes of this National Coverage Determination (NCD). This prohibition does not extend to the results of blood gas tests conducted by a hospital certified to do such tests.   When the arterial blood gas and the oximetry studies are both used to document the need for home oxygen therapy and the results are conflicting, the arterial blood gas study is the preferred source of documenting medical need.   Required qualifying arterial blood gas or oximetry studies must be performed at the time of need. The time of need is defined as during the patients illness when the presumption is that the provision of oxygen in the home setting will improve the patient s condition. For an inpatient hospital patient the time of need is within 2 days of discharge. For those patients whose initial oxygen prescription does not originate during an inpatient hospital stay, the time of need is during the period when the treating practitioner notes signs and symptoms of illness that can be relieved by oxygen in the patient who is to be treated at home.   Patients exhibiting hypoxemia are defined using the clinical criteria below:   Group I:    An arterial PO2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88%, taken at rest, breathing room air; or   An arterial PO2 at or below 55 mm Hg, or an arterial oxygen saturation at or below 88%, taken during sleep for a patient who demonstrates an arterial PO2 at or above 56 mm Hg, or an arterial oxygen saturation at or above 89%, while awake; or a greater than normal fall in oxygen level during sleep (a decrease in arterial PO2 more than 10 mm Hg, or decrease in arterial oxygen saturation more than 5%) associated with symptoms or signs reasonably attributable to hypoxemia (e.g., impairment of cognitive processe s and nocturnal restlessness or insomnia). In either of these cases, coverage is provided only for use of oxygen during sleep, and then only one type of unit will be covered. Portable oxygen, therefore, would not be covered in this situation; or,   An arterial PO2 at or below 55 mm Hg or an arterial oxygen saturation at or below 88%, taken during exercise [defined as either the functional performance of the patient or a formal exercise test], for a patient who demonstrates an arterial PO2 at or above  56 mm Hg, or an arterial oxygen saturation at or above 89%, during the day while at rest. In this case, supplemental oxygen is provided for during exercise if the use of oxygen improves the hypoxemia that was demonstrated during exercise when the patient was breathing room air.   Group II: Coverage is available for patients whose  arterial PO2 is 56 -59 mm Hg or whose arterial blood oxygen saturation is 89%, if there is:    Dependent edema suggesting congestive heart failure; or,   Pulmonary hypertension or cor pulmonale, determined by measurement of pulmonary artery pressure, gated blood pool scan, echocardiogram, or "P" pulmonale on EKG (P wave greater than 3 mm in standard leads II, III, or AVFL; or,   Erythrocythemia with a hematocrit greater than 56%.