(Medicare National Coverage Determinations Manual)

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.   C.       Topical Application of Oxygen  Section C -Topical Application of Oxygen has been removed from NCD 20.29. Effective for dates of ser vice on and after (DATE), Medicare Administrative Contractors (MACs) acting within their respective jurisdictions may determine coverage of topical application of oxygen for chronic non- healing wounds.  Cross reference: 270.5 of this manual.  (This NCD wa s last reviewed April 2017)   20.30 - Microvolt T -Wave Alternans (MTWA)  (Rev.  182, Issued: 05- 22-15, Effective: 01 -13-15, Implementation: 06- 23-15)  A. General   Microvolt T -wave Alternans (MTWA) testing is a non -invasive diagnostic test that detects minute electrical activity in a portion of the electrocardiogram (ECG) known as the T -wave.  MTWA testing has a role in the stratification of patients who may be at ri sk for sudden cardiac death (SCD) from ventricular arrhythmias.   Within patient groups that may be considered candidates for implantable cardioverter defibrillator (ICD) therapy, a negative MTWA test may be useful in identifying low -risk patients who are unlikely to benefit from, and who may experience worse outcomes from, ICD placement.   Spectral analysis (SA) is a sensitive mathematical method of measuring and comparing time and the ECG signals. It requires specialized propriety electrodes to calculate m inute T-wave voltage changes.  Software then analyzes these microvolt changes and produces a report to be interpreted by a physician.  The Modified Moving Average (MMA) method uses a temporal domain in which T -wave alternans are assessed as a continuous variable along the complete ECG.  The MMA method of MTWA testing is performed using standard ambulatory ECG equipment.  B. Nationally Covered Indications   Effective for dates of service on and after March 21, 2006, MTWA diagnostic testing is covered for the evaluation of patients at risk for SCD, only when the SA method is used.  C. Nationally Non -Covered Indications   N/A  D. Other  Effective for dates of service on and after January 21, 2015, A/B MACs acting within their respective jurisdictions may determin e coverage of MTWA diagnostic testing for the evaluation of patients at risk for SCD using all other methods.  (This NCD last reviewed January 2015.)   20.31  Intensive Cardiac Rehabilitation (ICR) Programs  (Rev. 125, Issued: 09- 24-10, Effective: 08 -12-10, Implementation: 10- 25-10)  Intensive cardiac rehabilitation (ICR) refers to a physician -supervised program that furnishes cardiac rehabilitation services more frequently and often in a more rigorous manner.  As required by 1861(eee)(4)(A) of the Social Security Act (the Act), an ICR program must show, in peer -reviewed published research, that it accomplished one or more of the following for its patients: (1) positively affected the progression of coronary heart disease; (2) reduced the need fo r coronary bypass surgery; and, (3) reduced the need for percutaneous coronary interventions. The ICR program must also demonstrate through peer -reviewed published research that it accomplished a statistically significant reduction in five or more of the f ollowing measures for patients from their levels before cardiac rehabilitation services to after cardiac rehabilitation services: (1) low density lipoprotein; (2) triglycerides; (3) body mass index; (4) systolic blood pressure; (5) diastolic blood pressure ; and, (6) the need for cholesterol, blood pressure, and diabetes medications. Individual ICR programs must be approved through the national coverage determination process to ensure that they demonstrate these accomplishments.  20.31.1 - The Pritikin Progr am (Effective August 12, 2010)  (Rev. 125, Issued: 09- 24-10, Effective: 08 -12-10, Implementation: 10- 25-10)  A. General   The Pritikin diet was designed and adopted by Nathan Pritikin in 1955.  The diet was modeled after the diet of the Tarahumara Indians in Mexico, which consisted of 10% fat, 13% protein, 75- 80% carbohydrates and provided 15- 20 grams per day of crude fiber with only 75 mg/day of cholesterol.  Over the years, the Pritikin Program (also known as the Pritikin Longevity Program) evolved into a c omprehensive program that is provided in a physicians office and incorporates a specific diet (10% -15% of calories from fat, 15%-20% from protein, 65% -75% from complex carbohydrates), exercise, and counseling lasting 21- 26 days. An optional residential component is also available for participants.   B. Nationally Covered Indications   Effective for claims with dates of service on and after August 12, 2010, the Pritikin Program meets the intensive cardiac rehabilitation (ICR) program requirements set forth by Congress in 1861(eee)(4)(A) of the Social Security Act and in regulations at 42 C.F.R. 410.49(c) and, as such, has been included on the list of approved ICR programs available at http://www.cms .gov/MedicareApprovedFacilitie/ .  C. Nationally Non -Covered Indications   Effective August 12, 2010, if a specific ICR program is not included on the list as a Medicare- approved ICR program, it is non- covered.  D. Other  N/A  (This NCD last reviewed August 2010.)   20.31.2  Ornish Program for Reversing Heart Disease (Effective August 12, 2010)  (Rev. 125, Issued: 09- 24-10, Effective: 08 -12-10, Implementation: 10- 25-10)  A. General   The Ornish Program for Reversing Heart Disease (also known as the Multisite Cardiac Lifestyle Intervention Program, the Multicenter Cardiac Lifestyle Intervention Program, and the Lifestyle Heart Trial Program) was initially described in the 1970s and incorporates comprehensive lifestyle modifications including exercise, a low -fat diet, smoking cessation, stress management training, and group support sessions.  Over the years, the Ornish Program has been refined but continues to focus on these specific risk factors.   B. Nationally Covered Indications   Effective for claims with dates of service on and after August 12, 2010, the Ornish Program for Reversing Heart Disease meets the Intensive Cardiac Rehabilitation (ICR) program requirements set forth by Congress in 1861(eee)(4)(A) of the Soci al Security Act, and in regulations at 42 C.F.R. 410.49(c) and, as such, has been included on the list of approved ICR programs available at http://www.cms.gov/MedicareApprovedFacilitie/.  C. Nationally Non -Covered Indications   Effective August 12, 2010, if a specific ICR program is not included on the list as a Medicare-  approved ICR program, it is non- covered.   D. Other  N/A  (This NCD last reviewed August 2010.)   20.31.3  Benson -Henry Institute Cardiac Wellness Program (Effective May 6, 2014)  (Rev.  175, Issued: 10-03-14, Effective: 05-06-14, Implementation: 11-04-14 )   General   The fundamental concepts of the Benson- Henry Institute Cardiac Wellness Program were developed by Herbert Benson, MD, over 40 years ago.  Benson states that in the middle 1960s, when I noticed that peoples blood pressures were higher during visits to my office than at other times and wondered whether stress wasnt causing that rise.  Stress wasnt on the radar then, so I began investigating a connection between stress and hypertension. ( http://www.ideafit.com/fitness -library/mind -body- medicine- balanced -approach )  The Cardiac Wellness Program is a multi -component intervention program that includes supervised exercise, behavioral interventions, and counseling, and is designed to reduce cardiovascular ris k and improve health outcomes.   B. Nationally Covered Indications   Effective for claims with dates of service on and after May 6, 2014, the Benson- Henry Institute Cardiac Wellness Program meets the Intensive Cardiac Rehabilitation (ICR) program requirements set forth by Congress in 1861(eee)(4)(A) of the Social Security Act, and in regulations at 42 C.F.R. 410.49(c) and, as such, has been included on the list of approved ICR programs available at http://www.cms.gov/Medicare/Medicare -General -Information/MedicareApprovedFacilitie/.  C. Nationally Non- Covered Indications   Effective May 6, 2014, if a specific ICR prog ram is not included on the above -noted list as a Medicare -approved ICR program, it is non- covered.   D. Other   N/A  (This NCD last reviewed May 6, 2014.)   20.32  Transcatheter Aortic Valve Replacement (TAVR)  (Rev. 10179, Issued: 0 6-10-20, Effective: 06 -21-19, Implementation: 06- 12-20  A. General   Transcatheter aortic valve replacement (TAVR -  also known as TAVI or transcatheter aortic valve implantation) is used in the treatment of aortic stenosis. A bioprosthetic valve is inserted percutan eously using a catheter and implanted in the orifice of the aortic valve.   B. Nationally Covered Indications   The Centers for Medicare & Medicaid Services (CMS) covers transcatheter aortic valve replacement (TAVR) under Coverage with Evidence Development ( CED) with the following conditions:   A. TAVR is covered for the treatment of symptomatic aortic valve stenosis when furnished according to a Food and Drug Administration (FDA) -approved indication and when all of the following conditions are met:   1. The procedure is furnished with a complete aortic valve and implantation system that has received FDA premarket approval (PMA) for that system's FDA approved indication.   2. The patient (preoperatively and postoperatively) is under the care of a heart team: a coh esive, multi- disciplinary, team of medical professionals. The heart team concept embodies collaboration and dedication across medical specialties to offer optimal patient- centered care. The heart team includes the following:   a. Cardiac surgeon and an interve ntional cardiologist experienced in the care and treatment of aortic stenosis who have:  i. independently examined the patient face -to-face, evaluated the patients suitability for surgical aortic valve replacement (SAVR), TAVR or medical or palliative therapy ; ii. documented and made available to the other heart team members the rationale for their clinical judgment.  b. Providers from other physician groups as well as advanced patient practitioners, nurses, research personnel and administrators.  3. The heart team's int erventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra -operative technical aspects of TAVR.   4. TAVR must be furnished in a hospital with the appropriate infrastructure that includes but is not limited to: a. On-site heart valve surgery and interventional cardiology programs, b. Post-procedure intensive care facility with personnel experienced in managing patients who have undergone open- heart valve procedures,  c. Appropriate volume requirements per the applicable qualifications below: