(Medicare National Coverage Determinations Manual)

24-hour attended coverage means there must be, at a monitoring site or central data center, an EKG technician or other non- physician, receiving calls and/or EKG data; tape recording devices do not meet this requirement. Further, such technicians should have immediate, 24 -hour access to a physician to review transmitted data and make clinical decisions regarding the patient.  The technician should also be instructed as to when and how to contact available facilities to assist the patient in case of emergencies.   C. Nationally N on-Covered Indications   The following indications are non- covered nationally unless otherwise specified below:   1. The time -sampling mode of operation of ambulatory EKG cardiac event monitoring/recording.  2. Separate physician services other than those re ndered by an IDTF unless rendered by the patients attending or consulting physician.  3. Home EKG services without documentation of medical necessity.  4. Emergency EKG services by a portable x- ray supplier without a physician in attendance at the time of  service or immediately thereafter.   5. 24-hour attended coverage used as early post -hospital monitoring of patients discharged after MI unless provision is made for such 24- hour attended coverage in the manner described in section B.5. above.   6. Any marketed Food and Drug Administration (FDA) -approved ambulatory cardiac monitoring device or service that cannot be categorized according to the framework below.  D. Other  Ambulatory cardiac monitoring performed with a marketed, FDA -approved device, is eligib le for coverage if it can be categorized according to the framework below.  Unless there is a specific NCD for that device or service, determination as to whether a device or service that fits into the framework is reasonable and necessary is according to local A/B MAC discretion.  Electrocardiographic Services Framework           Attended       Pre-symptom memory loop          Insertable     Non-attended        Non- insertable   Patient/Event- Activated  Intermittent Recorders                  Post-symptom (no memory loop) _____   Non- attended  Non-Activated  Continuous Recorders ________Dynamic Electrocardiography _______ Non- attended                                                      (e.g., Holter  Monitor)   20.16 - Cardiac Output Monitoring By Thoracic Electrical Bioimpedance (TEB)  Various Effective Dates Below  (Rev. 173, Issued: 09- 04-14, Effective: Upon Implementation: of ICD -10, Implementation: Upon Implementation of ICD -10)  A. General   Thoracic electrical bioimpedance (TEB) devices, a form of plethysmography, monitor cardiac output by non- invasively measuring hemodynamic parameters, including: stroke volume, systemic vascular resistance, and thoracic fluid status. Under a previous coverage determination, effective for services performed on and after July 1, 1999, use of TEB was covered for the noninvasive diagnosis or monitoring of hemodynamics in patients with suspected or known cardiovascular disease. In reconsidering this policy, the Centers for Medicare & Medicaid Services (CMS) concluded that this use was neither sufficiently defined nor supported by available clinical literature to offer the guidance necessary for practitioners to determine when TEB would be covered for patient management. Therefore, CMS revised its coverage policy language in response to a request for reconsideration to offer more explicit guidance and clarity for coverage of TEB based on a complete and updated literature review.   B. Nationally Covered Indications   Effective for services performed on and after January 23, 2004, TEB is covered for the following uses:   1. Differentiation of cardiogenic from pulmonary causes of acute dyspnea when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.  2. Optimization of atrioventricular (A/V) interval for patients with A/V sequential cardiac pacemake rs when medical history, physical examination, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.   3. Monitoring of continuous inotropic therapy for patients with terminal congestive heart failure, when those patients have chosen to die with comfort at home, or for patients waiting at home for a heart transplant.   4. Evaluation for rejection in patients with a heart trans plant as a predetermined alternative to a myocardial biopsy. Medical necessity must be documented should a biopsy be performed after TEB.  5. Optimization of fluid management in patients with congestive heart failure when medical history, physical examinat ion, and standard assessment tools provide insufficient information, and the treating physician has determined that TEB hemodynamic data are necessary for appropriate management of the patient.  C. Nationally Non -Covered Indications   1. TEB is non -covered when used for patients:   a) With proven or suspected disease involving severe regurgitation of the aorta;  b) With minute ventilation (MV) sensor function pacemakers, since the device  may adversely affect the functioning of that type of pacemaker;  c) During cardiac bypass surgery; or,  d) In the management of all forms of hypertension (with the exception of drug- resistant hypertension as outlined below).  2. All other uses of TEB not otherwis e specified remain non -covered.   D. Other  A/B MACs have discretion to determine whether the use of TEB for the management of drug- resistant hypertension is reasonable and necessary. Drug resistant hypertension is defined as failure to achieve goal blood pressure in patients who are adhering to full doses of an appropriate 3 -drug regimen that includes a diuretic.  Effective November 24, 2006, after reconsideration of Medicare policy, CMS will continue current Medicare policy for TEB.  20.17 - Noninvasive Te sts of Carotid Function  (Rev. 1, 10- 03-03) CIM 50 -37  Noninvasive tests of carotid function aid physicians in studying and diagnosing carotid disease.  There are varieties of these tests which measure various anatomical and physiological aspects of carotid function, including pressure (systolic, diastolic, and pulse), flow, collateral circulation, and turbulence.   For operational purposes, it is useful to classify noninvasive tests of carotid function into direct and indirect tests.  The direct tests  examine the anatomy and physiology of the carotid artery, while the indirect tests examine hemodynamic changes in the distal beds of the carotid artery (the orbital and cerebral circulations).   It is important to note that the names of these tests are not standardized.  Following are some of the acceptable tests, recognizing that this list is not inclusive and that local medical consultants should make determinations:   Direct Tests    Carotid Phonoangiography  Direct Bruit Analysis   Spectral Bruit Analysis   Doppler Flow Velocity   Ultrasound Imaging including Real Time   B-Scan and Doppler Devices   Indirect Tests    Periorbital Directional Doppler Ultrasonography   Oculoplethysmography   Ophthalmodynamometry  20.18 - Carotid Body Resection/Carotid Body Denervation  (Rev . 1, 10- 03-03) CIM 35 -7  Carotid body resection is occasionally used to relieve pulmonary symptoms, including asthma, but has been shown to lack general acceptance of the professional medical community.  In addition, controlled clinical studies establishing the safety and effective -ness of this procedure are needed. Therefore, all carotid body resections to relieve pulmonary symptoms must be considered investigational and cannot be considered reasonable and necessary within the meaning of 1862(a)(l)  of the Act.  No program reimbursement may be made in such cases.   However, there is one instance where carotid body resection has been accepted by the medical community as effe ctive.  That instance is when evidence of a mass in the carotid body, with or without symptoms, indicates the need for surgery to remove the carotid body tumor.  Denervation of a carotid sinus to treat hypersensitive carotid sinus reflex is another procedure performed in the area of the carotid body.  In the case of hypersensitive carotid sinus, light pressure on the upper part of the neck (such as might be experie nced when turning or raising ones head) results in symptoms such as dizziness or syncope due to hypotension and slowed heart rate.  Failure of medical therapy and continued deterioration in the condition of the patient in such cases may indicate need for surgery.   Denervation of the carotid sinus is rarely performed, but when elected as the therapy of choice with the above indications, this procedure may be considered reasonable and necessary.   20.19 - Ambulatory Blood Pressure Monitoring  (Rev. 1, 10- 03-03) CIM 50 -42  Ambulatory blood pressure monitoring (ABPM) involves the use of a noninvasive device which is used to measure blood pressure in 24- hour cycles.  These 24 -hour measurements are stored in the device and are later interpreted by the physician.  A BPM must be performed for at least 24 hours to meet coverage criteria.   The ABPM is only covered for those patients with suspected white coat hypertension.  Suspected white coat hypertension is defined as   1.  Office blood pressure >  140/90 mm Hg on at le ast three separate clinic/office visits with two separate measurements made at each visit;  2.  At least two documented blood pressure measurements taken outside the office which are < 140/90 mm Hg; and   3.  No evidence of end -organ damage.   The informati on obtained by ABPM is necessary in order to determine the appropriate management of the patient. ABPM is not covered for any other uses.  In the rare circumstance that ABPM needs to be performed more than once in a patient, the qualifying criteria describ ed above must be met for each subsequent ABPM test.  For those patients that undergo ABPM and have an ambulatory blood pressure of <  135/85 with no evidence of end- organ damage, it is likely that their cardiovascular risk is similar to that of normotensive s.  They should be followed over time.  Patients for which ABPM demonstrates a blood pressure of >  135/85 may be at increased cardiovascular risk, and a physician may wish to consider antihypertensive therapy.   20.20 - External Counterpulsation (ECP) Therapy for Severe Angina (Effective March 20, 2006)  (Rev. 50, Issued:  03- 31-06; Effective:  03 -20-06; Implementation:  04- 03-06)  A. General   External counterpulsation (ECP), commonly referred to as enhanced external counterpulsation, is a noninvasive outpatient treatment for coronary artery disease refractory to medical and/or surgical therapy.  Although ECP devices are cleared by the Food and Drug Administration (FDA)  for use in treating a variety of cardiac conditions, including stable or unstable angina pectoris, acute myocardial infarction and cardiogenic shock, the use of this device to treat cardiac conditions other than stable angina pectoris is not covered, sinc e only that use has developed sufficient evidence to demonstrate its medical effectiveness.  Non -coverage of hydraulic versions of these types of devices remains in force.   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.