evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
(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:
(Medicare National Coverage Determinations Manual)
 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.
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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.   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
(Medicare National Coverage Determinations Manual)
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)
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
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
(Medicare National Coverage Determinations Manual)
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.
(Medicare National Coverage Determinations Manual)
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:   There are two sets of qualifications; the first set outlined below is for hospital programs and heart teams without previous TAVR experience and the second set is for those with TAVR experience.   Qualifications to begin a TAVR program for hospitals without TAVR experience:   The hospital program must have the following:   a.  50 open heart surgeries in the previous year prior to TAVR program initiation, and;  b.  20 aortic valve related procedures in the 2 years prior to TAVR program initiation, and;  c.  2 physicians with cardiac surgery privileges, and;  d.  1 physician with interventional cardiology privileges, and;  e.  300 percutaneous coronary interventions (PCIs) per year.   Qualifications to begin a TAVR program for heart teams without TAVR experience:   The heart team must include:
(Medicare National Coverage Determinations Manual)
Qualifications to begin a TAVR program for heart teams without TAVR experience:   The heart team must include:  a. Cardiovascular surgeon with:  i.  100 career open heart surgeries of which  25 are aortic valve related; and,  b. Interventional cardiologist  with:  i. Professional experience of  100 career structural heart disease procedures; or,  30 left -sided structural  procedures per year; and,  ii. Device- specific training as required by the manufacturer.   Qualifications for hospital programs with TAVR experienc e:  The hospital program must maintain the following:   a.  50 AVRs (TAVR or SAVR) per year including  20 TAVR procedures in the prior year ; or,  b.  100 AVRs (TAVR or SAVR) every 2 years, including  40 TAVR procedures in the prior 2 years; and,  c.  2 physicians with cardiac surgery privileges; and, d.  1 physician with interventional cardiology privileges, and  e.  300 percutaneous coronary interventions (PCIs) per year; and,   5. The heart team and hospital are participating in a prospective, national, audited registry that: 1) consecutively enrolls TAVR patients; 2) accepts all manufactured devices; 3) follows the patient for at least one year; and, 4) complies with relevant regulations relating to protecting human research subjects, including 45 CFR Part 46 and 21 CFR Parts 50 & 56.  The following outcomes must be tracked by the registry; and the registry must be designed to permit identification and analysis of patient, practitioner and facility level variables that predict each of these outcomes:   i. Stroke;  ii. All-cause mortality;  iii. Transient Ischemic Attacks (TIAs);  iv. Major vascular events;  v. Acute kidney injury;  vi. Repeat aortic valve procedures;  vii. New permanent pacemaker implantation;  viii. Quality of Life (QoL).   6. The registry shall collect all data necessary and have a written  executable analysis plan in place to address the following questions (to appropriately address some questions, Medicare claims or other outside data may be necessary). Specifically, for the CED question iv, this must be addressed through a composite metri c. For the below CED questions (i -iv), the results must be reported publicly as described in CED criterion k.
(Medicare National Coverage Determinations Manual)
i. When performed outside a controlled clinical study, how do outcomes and adverse events compare to the pivotal clinical studies? ii. What is the long term durability of the device?  iii. What are the long term outcomes and adverse events? iv. What morbidity and procedure -related factors contribute to TAVR patients outcomes?   Consistent with section 1142 of the Act, the Agency for Healthcare Resea rch and Quality (AHRQ) supports clinical research studies that CMS determines meet the above- listed standards and address the above -listed research questions.   B. TAVR is covered for uses that are not expressly listed as an FDA -approved indication when per formed within a clinical study that fulfills all of the following:   1. The heart team's interventional cardiologist(s) and cardiac surgeon(s) must jointly participate in the intra -operative technical aspects of TAVR.   2. As a fully -described, written part of its  protocol, the clinical research study must critically evaluate not only each patient's quality of life pre - and post -TAVR (minimum of 1 year), but must also address at least one of the following questions:    What is the incidence of stroke?   What is the rat e of all -cause mortality?   What is the incidence of new permanent pacemaker implantation?   What is the incidence of transient ischemic attacks (TIAs)?   What is the incidence of major vascular events?   What is the incidence of acute kidney injury?   What is the i ncidence of repeat aortic valve procedures?   3. The clinical study must adhere to the following standards of scientific integrity and relevance to the Medicare population:   a. The principal purpose of the study is to test whether the item or service meaningfully improves health outcomes of affected beneficiaries who are represented by the enrolled subjects.   b. The rationale for the study is well supported by available scientific and medical evidence.   c. The study results are not anticipated to unjustifiably duplicate existing knowledge.  d. The study design is methodologically appropriate and the anticipated number of enrolled subjects is sufficient to answer the research question(s) being asked in the National Coverage Determination.  e. The study is sponsored by an organization or individual capable of completing it successfully.