(Medicare National Coverage Determinations Manual)

B. Nationally Covered Indications   Effective for services performed on or after Ju ly 1, 1999, coverage is provided for the use of ECP for patients who have been diagnosed with disabling angina (Class III or Class IV, Canadian Cardiovascular Society Classification or equivalent classification) who, in the opinion of a cardiologist or car diothoracic surgeon, are not readily amenable to surgical intervention, such as PTCA or cardiac bypass, because:   1.  Their condition is inoperable, or at high risk of operative complications or post -operative failure;   2.  Their coronary anatomy is not r eadily amenable to such procedures; or   3.  They have co- morbid states that create excessive risk.   A full course of therapy usually consists of 35 one -hour treatments which may be offered once or twice daily, usually 5 days per week.  The patient is pla ced on a treatment table where their lower trunk and lower extremities are wrapped in a series of three compressive air cuffs which inflate and deflate in synchronization with the patients cardiac cycle.   During diastole, the three sets of air cuffs are i nflated sequentially (distal to proximal) compressing the vascular beds within the muscles of the calves, lower thighs and upper thighs.  This action results in an increase in diastolic pressure, generation of retrograde arterial blood flow and an increase  in venous return.  The cuffs are deflated simultaneously just prior to systole which produces a rapid drop in vascular impedance, a decrease in ventricular workload and an increase in cardiac output.  The augmented diastolic pressure and retrograde aortic  flow appear to improve myocardial perfusion, while systolic unloading appears to reduce cardiac workload and oxygen requirements.  The increased venous return coupled with enhanced systolic flow appears to increase cardiac output.  As a result of this tre atment, most patients experience increased time until onset of ischemia, increased exercise tolerance, and a reduction in the number and severity of anginal episodes.  Evidence was presented that this effect lasted well beyond the immediate post -treatment phase, with patients symptom -free for several months to 2 years.  This procedure must be done under direct supervision of a physician.  C. Nationally Non -Covered Indications   All other cardiac conditions not otherwise specified as nationally covered for the use of ECP remain nationally non- covered.   (This NCD last reviewed March 2006.)   20.21 - Chelation Therapy for Treatment of Atherosclerosis  (Rev. 1, 10- 03-03) CIM 35 -64  Chelation therapy is the application of chelation techniques for the therapeutic or preventive effects of removing unwanted metal ions from the body.  The application of chelation therapy using ethylenediamine -tetra-acetic acid (EDTA) for the treatment and  prevention of atherosclerosis is controversial.  There is no widely accepted rationale to explain the beneficial effects attributed to this therapy.  Its safety is questioned and its clinical effectiveness has never been established by well -designed, cont rolled clinical trials.  It is not widely accepted and practiced by American physicians. EDTA chelation therapy for atherosclerosis is considered experimental.  For these reasons, EDTA chelation therapy for the treatment or prevention of atherosclerosis is  not covered.  Some practitioners refer to this therapy as chemoendarterectomy and may also show a diagnosis other than atherosclerosis, such as arteriosclerosis or calcinosis.  Claims employing such variant terms should also be denied under this section.  Cross -reference:  20.22.   20.22 - Ethylenediamine -Tetra -Acetic (EDTA) Chelation Therapy for Treatment of Atherosclerosis  (Rev. 1, 10- 03-03) CIM 45 -20  The use of EDTA as a chelating agent to treat atherosclerosis, arteriosclerosis, calcinosis, or similar generalized condition not listed  by the FDA as an approved use is not covered. Any such use of EDTA is considered experimental.  See 20.21 for an explanation of this conclusion.  20.23 - Fabric Wrapping of Abdominal Aneurysms  (Rev. 1, 10- 03-03)  Not Covered  CIM 35 -34  Fabric wrapping of abdominal aneurysms is not a covered Medicare procedure.  This is a treatment for abdominal aneurysms which involves wrapping aneurysms with cellophane or fascia lata.  This procedure  has not been shown to prevent eventual rupture.  In extremely rare instances, external wall reinforcement may be indicated when the current accepted treatment (excision of the aneurysm and reconstruction with synthetic materials) is not a viable alternative, but external wall reinforcement is not fabric wrapping.  Accordingly, fabric wrapping of abdominal aneurysms is not considered reasonable and necessary within the meaning of 1862(a)(1)  of the Act.   20.24 - Displacement Cardiography (Rev. 1, 10- 03-03) CIM 50 -50  Displacement cardiography, including cardiokymography and photokymography, is a noninvasive diagnostic test used in evaluating coronary artery disease.   A.  Cardiokymography   Cardiokymography is covered for services rendered on or after October 12, 1988.  Cardiokymography is a covered service only when it is used as an adjunct to electrocardiographic stress testing in evaluating coronary artery disease and only when the following clinical indications are present:    For male patients, atypical angina pectoris or nonischemic chest pain; or   For female patients, angina, either typical or atypical.   B.  Photokymography -  Not Covered   Photokymography remains excluded from coverage.  20.25 - Cardiac Catheterization Performed in Other Than a Hospital Setting (RETIRED)  (Rev. 11892; I ssued: 03 -09-23; Effective: 04 -10-23; Implementation:04- 10-23)    This section of the NCD Manual was repealed January 12, 2006.   20.26 - Partial Ventriculectomy  (Rev. 1, 10- 03-03) CIM 35 -95  (Also Known as Ventricular Reduction, Ventricular Remodeling, or Heart Volume Reduction Surgery)   Not Covered   Partial ventriculectomy , also known as ventricular reduction, ventricular remodeling, or heart volume reduction surgery, was developed by a Brazilian surgeon and has been performed only on a limited basis in the United States.  This procedure is performed on patients with enlarg ed hearts due to end- stage congestive heart failure.  Partial ventriculectomy involves reducing the size of an enlarged heart by excising a portion of the left ventricular wall followed by repair of the defect.  It is asserted that this procedure makes the failing heart pump better by improving the efficiency of the remaining left ventricle.   Since the mortality rate is high and there are no published scientific articles or clinical studies regarding partial ventriculectomy, this procedure cannot be conside red reasonable and necessary within the meaning of 1862(a)(1)  of the Act.  Therefore, partial ventriculectomy is not covered by Medicare.   20.27 - Cardiointegram (CIG) as an Alternative to Stress Test or Thallium Stress Test  (Rev. 1, 10- 03-03) CIM 50 -47  Not Covered   A cardiointegram device consists of a microcomputer which receives output from a standard electrocardiogram (EKG) and transforms it to produce a graphic repre sentation of heart electrophysiologic signals. This procedure is used primarily as a substitute for Exercise Tolerance Testing with Thallium Imaging in patients for whom a resting EKG may be inadequate to identify changes compatible with coronary artery di sease. Because this device is still considered investigational pending additional data on its clinical efficacy/sensitivity and value as a diagnostic tool, program payment may not be made for its use at this time.   20.28  Therapeutic Embolization  (Rev. 1, 10- 03-03)  CIM 35 -35  Therapeutic embolization is covered when done for hemorrhage, and for other conditions amenable to treatment by the procedure, when reasonable and necessary for the individual patient.  Renal embolization for the treatment of renal a denocarcinoma continues to be covered, effective December 15, 1978, as one type of therapeutic embolization, to:    Reduce tumor vascularity preoperatively;   Reduce tumor bulk in inoperable cases; or   Palliate specific symptoms.   20.29  Hyperbaric Oxygen Therapy  (Rev.203, Issued:11- 17-17, Effective:04 - 03-17, Implementation: 12- 18-17)  For purposes of coverage under Medicare, hyperbaric oxygen (HBO) therapy is a modality in which the entire body is exposed to oxygen under increased atmospheric pressure.   A.       Covered Conditions  Program reimbursement for HBO therapy will be limited to that which is administered in a chamber (including the one man unit) and is limited to the following conditions:  1. Acute carbon monoxide int oxication, 2. Decompression illness,  3. Gas embolism,  4. Gas gangrene,  5. Acute traumatic peripheral ischemia. HBO therapy is a valuable adjunctive treatment to be used in combination with accepted standard therapeutic measures when loss of function, limb, or life is threatened.  6. Crush injuries and suturing of severed limbs. As in the previous conditions, HBO therapy would be an adjunctive treatment when loss of function, limb, or life is threatened.  7. Progressive necrotizing infections (necrotizing fasciitis), 8. Acute peri pheral arterial insufficiency,  9. Preparation and preservation of compromised skin grafts (not for primary management of wounds), 10. Chronic refractory osteomyelitis, unresponsive to conventional medical and surgical management,  11. Osteoradionecrosis as an adjunct to conventional treatment,  12. Soft tissue radionecrosis as an adjunct to conventional treatment,  13. Cyanide poisoning, 14. Actinomycosis, only as an adjunct to conventional therapy when the disease process is refractory to antibiotics and surgical treatment,  15. Diabetic wounds of the lower extremities in patients who meet the following three criteria:  a. Patient has type I or type II diabetes and has a lower extremity wound that is due to diabetes ; b. Patient has a wound classified as Wagner grade III or hig her; and c. Patient has failed an adequate course of standard wound therapy.  The use of HBO therapy is covered as adjunctive therapy only after there are no measurable signs of healing for at least 30 days of treatment with standard wound therapy and must be used in addition to standard wound care. Standard wound care in patients with diabetic wounds includes: assessment of a patients vascular status and correction of any vascular problems in the affected limb if possible, optimization of nutritional status, optimization of glucose control, debridement by any means to remove devitalized tissue, maintenance of a clean, moist bed of granulation tissue with appropriate moist dressings, appropriate off -loading, and necessary treatment to resolve any infection that  might be present. Failure to respond to standard wound care occurs when there are no measurable signs of healing for at least 30 consecutive days. Wounds must be evaluated at least every 30 days during administration of HBO therapy. Continued treatment wi th HBO therapy is not covered if measurable signs of healing have not been demonstrated within any 30- day period of treatment.  B.        Non -covered Conditions   All other indications not specified under 270.4(A) are not covered under the Medicare program . No program payment may be made for any conditions other than those listed in 270.4(A).  No program payment may be made for HBO in the treatment of the following conditions:   1. Cutaneous, decubitus, and stasis ulcers.  2. Chronic peripheral vascular insufficien cy. 3. Anaerobic septicemia and infection other than clostridial.  4. Skin burns (thermal).  5. Senility.  6. Myocardial infarction.  7. Cardiogenic shock.  8. Sickle cell anemia.  9. Acute thermal and chemical pulmonary damage, i.e., smoke inhalation with pulmonary. 10. Acute or chronic cerebral vascular insufficiency.  11. Hepatic necrosis.  12. Aerobic septicemia.  13. Nonvascular causes of chronic brain syndrome (Picks disease, Alzheimers disease, Korsakoffs disease).  14. Tetanus.  15. Systemic aerobic infection.  16. Organ transplantation. 17. Organ storag e. 18. Pulmonary emphysema.  19. Exceptional blood loss anemia. 20. Multiple Sclerosis.  21. Arthritic Diseases.  22. Acute cerebral edema.