evekhm/cms_iom_500 huggingface dataset:
(Medicare National Coverage Determinations Manual)
B. Nationally Covered Indications  1. Post -cardiotomy ( effective for services performed on or after October 18, 1993)  Post-cardiotomy is the period following open- heart surgery. VADs used for support of blood circulation post -cardiotomy are covered only if they have received approval from the Food and Drug Administration (FDA) for that purpose, and the VADs are used according to the FDA -approved labeling instructions.  2. Left ventricular assist devices (LVADs) are covered if they are FDA approved for short -term (e.g., bridge -to-recovery and bridge -to-transpla nt) or long- term (e.g., destination therapy) mechanical circulatory support for heart failure patients who meet the following criteria:   Have New York Heart Association (NYHA) Class IV heart failure; and   Have a left ventricular ejection fraction (LVEF)  25%; and   Are inotrope dependent  OR have a Cardiac Index (CI) < 2.2 L/min/m2, while not on inotropes, and also meet one of the following:  o Are on optimal medical management (OMM), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond; or  o Have advanced heart failure for at least 14 days and are dependent on an intraaortic balloon  pump (IABP) or similar temporary mechanical circulatory support for at least 7 days.  Beneficiaries receiving a VAD must be managed by an explicitly identified, cohesive, multidisciplinary team of medical professionals with appropriate qualifications, tra ining, and experience.   The team embodies collaboration and dedication across medical specialties to offer optimal patient- centered care.   Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participa te in informed decision making.  The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD.  The team must include, at a minimum:   At least one physician with cardiot horacic surgery privileges and individual experience implanting at least 10 durable, intracorporeal, left ventricular assist devices over the course of the previous 36 months with activity in the last year.   At least one cardiologist trained in advanced
(Medicare National Coverage Determinations Manual)
surgery privileges and individual experience implanting at least 10 durable, intracorporeal, left ventricular assist devices over the course of the previous 36 months with activity in the last year.   At least one cardiologist trained in advanced hea rt failure with clinical competence in medical - and device -based management including VADs, and clinical competence in the management of patients before and after placement of a VAD.   A VAD program coordinator.  A social worker.   A palliative care specialist.  Facilities must be credentialed by an organization approved by CMS.  The process for organizations to apply for CMS approval to be designated as a credentialing organization for LVAD facilities is posted on our web site along with a list of approved crede ntialing organizations, approved standard versions, and credentialed facilities: http://www.cms.gov/Medicare/Medicare -General -Information/MedicareApprovedFacilitie/VAD -Destination -Therapy -Facilities.html  C. Nationally Non -Covered Indications  All other indications for the use of VADs not otherwise listed remain non- covered, except in the context of Category B investigational device exemption clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the National Coverage Determinations (NCD) Manual.  D. Other  This policy does not address coverage of VADs for right ventricular support, biventricular support, use in beneficiaries under the age of 18, use in beneficiaries with complex congenital heart diseas e, or use in beneficiaries with acute heart failure without a history of chronic heart failure. Coverage under section 1862(a)(1)(A) of the Act for VADs in these situations will be made by local Medicare Administrative Contractors within their respective jurisdictions.
(Medicare National Coverage Determinations Manual)
Destination therapy (DT) is for patients that require mechanical cardiac support.  The VADs used for DT are covered only if they have received approval from the FDA for that purpose.   Patient Selection (effective November 9, 2010):   The VA Ds are covered for patients who have chronic end- stage heart failure (New York Heart Association Class IV end -stage left ventricular failure) who are not candidates for heart transplantation at the time of VAD implant, and meet the following conditions:    Have failed to respond to optimal medical management (including beta -blockers and ACE inhibitors if tolerated) for 45 of the last 60 days, or have been balloon pump-dependent for 7 days, or IV inotrope -dependent for 14 days; and,    Have a left ventricular ejection fraction (LVEF) <25%; and,    Have demonstrated functional limitation with a peak oxygen consumption of 14 ml/kg/min unless balloon pump-  or inotrope -dependent or physically unable to perform the test.   Facility Criteria (effective October 30, 2013) :  Facilities currently credentialed by the Joint Commission for placement of VADs as DT may continue as Medicare- approved facilities until October 30, 2014.  At the conclusion of this transition period, these facilities must be in compliance with the foll owing criteria as determined by a credentialing organization.  As of the effective date, new facilities must meet the following criteria as a condition of coverage of this procedure as DT under section 1862(a)(1)(A) of the Social Security Act (the Act):   Beneficiaries receiving VADs for DT must be managed by an explicitly identified cohesive, multidisciplinary team of medical professionals with the appropriate qualifications, training, and experience.  The team embodies collaboration and dedication across m edical specialties to offer optimal patient- centered care.  Collectively, the team must ensure that patients and caregivers have the knowledge and support necessary to participate in shared decision making and to provide appropriate informed consent.  The team members must be based at the facility and must include individuals with experience working with patients before and after placement of a VAD.   The team must include, at a minimum:
(Medicare National Coverage Determinations Manual)
The team must include, at a minimum:    At least one physician with cardiothoracic surgery privileges and indi vidual experience implanting at least 10 durable, intracorporeal, left VADs as BTT or DT over the course of the previous 36 months with activity in the last year.    At least one cardiologist trained in advanced heart failure with clinical competence in medi cal and device- based management including VADs, and clinical competence in the management of patients before and after heart transplant.   A VAD program coordinator.   A social worker.    A palliative care specialist.   Facilities must be credentialed by an organization approved by the Centers for Medicare & Medicaid Services.   C. Nationally Non -Covered Indications   All other indications for the use of VADs not otherwise listed remain non- covered, except in the context of Category B investigational device exemption clinical trials (42 CFR 405) or as a routine cost in clinical trials defined under section 310.1 of the National Coverage Determinations (NCD) Manual.   D. Other   This policy does not address coverage of VADs fo r right ventricular support, biventricular support, use in beneficiaries under the age of 18, use in beneficiaries with complex congenital heart disease, or use in beneficiaries with acute heart failure without a history of chronic heart failure.  Coverage  under section 1862(a)(1)(A) of the Act for VADs in these situations will be made by local A/B MACs within their respective jurisdictions.   20.10 - Cardiac Rehabilitation Programs (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04 -10-23)    This section of the NCD Manual was repealed February 22, 2010, as a result of section 144 of the Medicare Improvements  for Patients  and Providers  Act. Instead, refer to Pub. 100- 04, chapter 32, section 140.   20.10.1  Cardiac Rehabilitation Programs for Chronic Heart Failure  (Rev. 171, Issued: 07- 18-14, Effective: 02 -18-14, Implementation: 08- 18-14)  A. General
(Medicare National Coverage Determinations Manual)
20.10.1  Cardiac Rehabilitation Programs for Chronic Heart Failure  (Rev. 171, Issued: 07- 18-14, Effective: 02 -18-14, Implementation: 08- 18-14)  A. General   As per sections 1861(s)(2)(CC) and 1861(eee)(1) of the Social Security Act, items and services furnished under a Cardiac Rehabilitation (CR) program may be covered under Medicare Part B.  Among other things, Medicare regulations at 42CFR410.49 define key terms, address the components of a CR program, establish the standards for physician supervision, and limit the maximum number of program sessions that may be furnished.  The regulations also describe the cardiac conditions that would enable a beneficiary to obtain CR services.   Effective for dates of service on and after January 1, 2010, coverage is  permitted for beneficiaries who have experienced one or more of the following:    Acute myocardial infarction within the preceding 12 months   Coronary artery bypasses surgery   Current stable angina pectoris   Heart valve repair or replacement   Percutaneous trans luminal coronary angioplasty (PTCA) or coronary stenting  A heart or heart -lung transplant   The Centers for Medicare & Medicaid Services (CMS) may add other cardiac conditions as specified through a national coverage determination (See 42 CFR 410.49(b)(1)(vii).   B. Nationally Covered Indications   Effective for dates of service on and after  February 18, 2014, CMS has determined that the evidence is sufficient to expand coverage for cardiac rehabilitation services under 42 CFR  410.49(b)(1)(vii) to beneficiaries with stable, chronic heart failure, defined as patients with left ventricular ejection fraction of 3 5% or less and New York Heart Association (NYHA) class II to IV symptoms despite being on optimal heart failure therapy for at least six weeks.  Stable patients are defined as patients who have not had recent (6 weeks) or planned (6 months) major cardiovascular hospitalizations or procedures.  (See section A above for other indications covered under 42 CFR 410.49(b)(1)(vii).   C. Nationally Non -Covered Indications
(Medicare National Coverage Determinations Manual)
Any cardiac indication not specifically identified in 42 CFR  410.49(b)(1)(vii) or identi fied as covered in this NCD or any other NCD in relation to cardiac rehabilitation services is considered non- covered.   D. Other  NA  (This NCD last reviewed February 2014.)   20.11 - Intraoperative Ventricular Mapping  (Rev. 1, 10- 03-03) CIM 35 -75  Intraope rative ventricular mapping is the technique of recording cardiac electrical activity directly from the heart.  The recording sites are usually identified from an anatomical grid and may consist of epicardial, intramural, and endocardial sites.  A probe wit h electrodes is used to explore these surfaces and generate a map that displays the sequence of electrical activation.  This information is used by the surgeon to locate precisely the site of an operative intervention.  The intraoperative ventricular mappi ng procedure is covered under Medicare only for the uses and medical conditions described below:    Localize accessory pathways associated with the Wolff -Parkinson- White (WPW) and other preexcitation syndromes;    Map the sequence of atrial and ventricular act ivation for drug- resistant supraventricular tachycardias;    Delineate the anatomical course of His bundle and/or bundle branches during corrective cardiac surgery for congenital heart diseases; and    Direct the surgical treatment of patients with refractory ventricular tachyarrhythmias.  20.12 - Diagnostic Endocardial Electrical Stimulation (Pacing)  (Rev. 1, 10- 03-03) CIM 35 -78  Diagnostic endocardial electrical stimulation (EES), also called programmed electrical stimulation of the heart, is cover ed under Medicare when used for patients with severe cardiac arrhythmias.
(Medicare National Coverage Determinations Manual)
Diagnostic endocardial electrical stimulation (EES), also called programmed electrical stimulation of the heart, is cover ed under Medicare when used for patients with severe cardiac arrhythmias.   Diagnostic endocardial electrical stimulation involves the detection and stimulation of cardiac electrical activity for the purpose of studying arrhythmias and abnormalities of the hearts conduction system.  Intracardiac electrode catheters, intracardiac and extracardiac recordings and a stimulator device are required.  From two to six multi -polar electrode catheters are inserted percutaneously, usually through the femoral veins, and advanced to the heart under fluoroscopic control.  Other venous or arterial routes may be employed as well.  An intracardiac His bundle cardiogram is usually obtained during EES as are conventional electrocardiograms.  No separate charge will be recognized for the His Bundle cardiogram.  (See 20.16.)   The EES is used to investigate the mechanisms, site of origin and pathways of cardiac arrhythmias as well as to select therapeutic approaches for their resolution.  EES is also employed to identify patients  at risk of sudden arrhythmic death.  The principal use for EES is in the diagnosis and treatment of sustained ventricular tachycardia.  However, it has also proven to be of value in the diagnosis and management of other complex arrhythmias, conduction def ects, and after cardiac arrest.   20.13 - HIS Bundle Study  (Rev. 1, 10- 03-03) CIM 50 -3
(Medicare National Coverage Determinations Manual)
20.13 - HIS Bundle Study  (Rev. 1, 10- 03-03) CIM 50 -3  The HIS Bundle Study is a specialized type of electrocardiography requiring catheterization of the right side of the heart and is a recognized diagnostic procedure. Medi care coverage of the procedure would be limited to selected patients: those with complex ongoing acute arrhythmias, those with intermittent or permanent heart block in whom pacemaker implantation is being considered, and those patients who have recently developed heart block secondary to a myocardial infarction.  When heart catheterization and the His Bundle Study are performed at the same time, the program will cover only one catheterization and a small additional charge for the study.  When a His bundle c ardiogram is obtained as part of a diagnostic endocardial electrical stimulation, no separate charge will be recognized for the His bundle study.  (See 20.12, Diagnostic Endocardial Electrical Stimulation.)   20.14 - Plethysmography  (Rev. 1, 10- 03-03) CIM 50 -6  Plethysmography involves the measurement and recording (by one of several methods) of changes in the size of a body part as modified by the circulation of blood in that part.  Plethysmography is of value as a noninvasive technique for diagnostic, preoperative and postoperative evaluation of peripheral artery disease in the internal medicine or vascular surgery practice.  It is also a useful tool for the preoperative podiatric evaluation of the diabetic patient or one who has intermittent claudication or other signs or symptoms indicative of peripheral vascular disease which have a bearing on the patients candidacy for foot surgery.   The oldest form of plethy smography is the venous occlusive pneumoplethysmography.  This method is cumbersome, time consuming, and requires considerable training to give useful, reproducible results.  Nonetheless, in the setting of the hospital vascular laboratory, this technique i s considered a reasonable and necessary procedure for the diagnostic evaluation of suspected peripheral arterial disease.  It is unsuitable for routine use in the physicians office.
(Medicare National Coverage Determinations Manual)
Recently, however, a number of other plethysmographic methods have been developed which make use of phenomena such as changes in electric impedance or changes in segmental blood pressure at constant volume to assess regional perfusion.  Several of these methods have reached a level of development which makes them clinically valuable.   Medicare coverage is extended to those procedures listed in Category I below when used for the accepted medical indications mentioned above.  The procedures in Category II are still considered experimental and are not covered at this time.  Denial  of claims because a noncovered procedure was used or because there was no medical indication for plethysmographic evaluation of any type should be based on 1862(a)(1)  of the Act.   Category I - Covered   Segmental Plethysmography -  Included under this procedure are services performed with a regional plethysmograph, differential plethysmograph, recording oscillometer, and a pulse volume recorder.   Electrical Impedance Plethy smography  Ultrasonic Measurement of Blood Flow (Doppler) -  While not strictly a plethysmographic method, this is also a useful tool in the evaluation of suspected peripheral vascular disease or preoperative screening of podiatric patients with suspected peripheral vascular compromise.  (See 220.5 for the applicable coverage policy on this procedure.)   Oculoplethysmography -  See 20.17, Noninvasive Tests of Carotid Function.   Strain Gauge Plethysmography -  This test is based on recording the non -pulsatile aspects of inflowing blood at various points on an extremity by a mercury -in-silastic strain gauge sensor.  The instrument  consists of a chart recorder, an automatic cuff inflation and deflation system, and a recording manometer.   Category II -  Experimental   The following methods have not yet reached a level of development such as to allow their routine use in the evaluation of suspected peripheral vascular disease.   Inductance Plethysmography -  This method is considered experimental and does not provide reproducible results.   Capacitance Plethysmography -  This method is considered experimental and does not provide reproducible results.   Mechanical Oscillometry -  This is a nonstandardized method which offers poor sensitivity and is not considered superior to the simple measurement of peripheral blood pressure.
(Medicare National Coverage Determinations Manual)
Mechanical Oscillometry -  This is a nonstandardized method which offers poor sensitivity and is not considered superior to the simple measurement of peripheral blood pressure.   Photoelectric Plethysmography -  This method is considere d useful only in determining whether or not a pulse is present and does not provide reproducible measurements of blood flow.  Differential plethysmography, on the other hand, is a system which uses an impedance technique to compare pulse pressures at various points along a limb, with a reference pressure at the mid -brachial or wrist level.  It is not clear whether this technique, as usually performed in the physicians office, meets the definition of plethysmography because quantitative measurements of bloo d flow are usually not made.  It has been concluded, in any event, that the differential plethysmography system is a blood pulse recorder of undetermined value which has the potential for significant overutilization.  Therefore, reimbursement for studies d one by techniques other than venous occlusive pneumoplethysmography should be denied, at least until additional data on these devices, including controlled clinical studies, become available.   20.15  Electrocardiographic Services  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD - 10)  A. General   1. An electrocardiogram (EKG) is a graphic representation of electrical activity within the heart.  Electrodes placed on the body in predetermined locations sense this electrical activity, which is then recorded by various means for review and interpretation.  EKG recordings are used to diagnose a wide range of heart disease and other conditions that manifest themselves by abnormal cardiac electrical activity.
(Medicare National Coverage Determinations Manual)
EKG services are covered diagnostic tests when there are documented signs and symptoms or other clinical indications for providing the service.  Coverage includes the review and interpret ation of EKGs only by a physician.  There is no coverage for EKG services when rendered as a screening test or as part of a routine examination unless performed as part of the one -time, Welcome to Medicare preventive physical examination under section 611 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.  2. Ambulatory electrocardiography (AECG) refers to services rendered in an outpatient setting over a specified period of time, generally while a patient is engaged in daily a ctivities, including sleep. AECG devices are intended to provide the physician with documented episodes of arrhythmia, which may not be detected using a standard 12- lead EKG.  AECG is most typically used to evaluate symptoms that may correlate with intermittent cardiac arrhythmias and/or myocardial ischemia.  Such symptoms include syncope, dizziness, chest pain, palpitations, or shortness of breath.  Additionally, AECG is used to evaluate patient response to initiation, revision, or discontinuation of arrhy thmic drug therapy.   3. The Centers for Medicare & Medicaid Services (CMS), through the national coverage determination (NCD) process, may create new ambulatory EKG monitoring device categories if published, peer -reviewed clinical studies demonstrate evidence of improved clinical utility, or equal utility with additional advantage to the patient, as indicated by improved patient management and/or improved health outcomes in the Medicare population (such as superior ability to detect serious or life -threaten ing arrhythmias) as compared to devices or services in the currently described categories below.  Descriptions of Ambulatory EKG Monitoring Technologies
(Medicare National Coverage Determinations Manual)
Descriptions of Ambulatory EKG Monitoring Technologies   1. Dynamic electrocardiography devices that continuously record a real -time EKG, commonly known as Hol ter monitors, typically record over a 24 -hour period.  The recording is captured either on a magnetic tape or other digital medium.  The data is then computer -analyzed at a later time, and a physician interprets the computer -generated report.  A 24- hour r ecording is generally adequate to detect most transient arrhythmias. Documentation of medical necessity is required for monitoring longer than 24 hours.  The recording device itself is not covered as durable medical equipment (DME) separate from the total diagnostic service.   2. An event monitor, or event recorder , is a patient -activated or event -activated EKG device that intermittently records cardiac arrhythmic events as they occur.  The EKG is recorded on magnetic tape or other digital medium.  Cardiac event monitor technology varies among different devices.  For patient -activated event monitors, the patient initiates recording when symptoms appear or when instructed to do so by a physician (e.g., following exercise).  For self -sensing, automatic ally triggered monitors, an EKG is automatically recorded when the device detects an arrhythmia, without patient intervention.  Some devices permit a patient to transmit EKG data transtelephonically (i.e., via telephone) to a receiving center where the dat a is reviewed.  A technician may be available at these centers to review transmitted data 24 hours per day.  In some instances, when the EKG is determined to be outside certain pre -set criteria by a technician or other non- physician, a physician is available 24 hours per day to review the transmitted data and to make clinical decisions regarding the patient.  These services are known as 24 -hour attended monitoring.  In other instances, transmitted EKG data is reviewed at a later time and are, therefore, considered non-attended.