Medicare National Coverage Determinations 
Manual 
Chapter 1, Part 1 (Sections 10  80.12) 
Coverage Determinations 
 
Table of Contents 
(Rev. 12112, Issued: 06-29-23) 
 
Transmittals for Chapter 1, Part 1 
 
Foreword - Purpose for National Coverage Determinations (NCD) Manual 
10 - Anesthesia and Pain Management 
10.1 - Use of Visual Tests Prior to and General Anesthesia During Cataract 
Surgery 
10.2 - Transcutaneous Electrical Nerve Stimulation (TENS) for Acute Post-
Operative Pain 
10.3 - Inpatient Hospital Pain Rehabilitation Programs 
10.4 - Outpatient Hospital Pain Rehabilitation Programs 
10.5 - Autogenous Epidural Blood Graft 
10.6 - Anesthesia in Cardiac Pacemaker Surgery 
20 - Cardiovascular System 
20.1 - Vertebral Artery Surgery 
20.2 - Extracranial - Intracranial (EC-IC) Arterial Bypass Surgery 
20.3 - Thoracic Duct Drainage (TDD) in Renal Transplants 
20.4  Implantable Cardioverter Defibrillators (ICDs) 
20.5- Extracorporeal Immunoadsorption (ECI) Using Protein A Columns   
(RETIRED) 
20.6 - Transmyocardial Revascularization (TMR) 
20.7 - Percutaneous Transluminal Angioplasty (PTA) (Various Effective Dates 
Below) 
20.8 - Cardiac Pacemakers (Various Effective Dates Below) 
20.8.1 - Cardiac Pacemaker Evaluation Services 
20.8.1.1 - Transtelephonic Monitoring of Cardiac Pacemakers 
20.8.2 - Self-Contained Pacemaker Monitors 
20.8.3  Single Chamber and Dual Chamber Permanent Cardiac 
Pacemakers 
                       20.8.4 Leadless Pacemakers  
           20.9 - Artificial Hearts And Related Devices (RETIRED)   
20.9.1 - Ventricular Assist Devices (Various Effective Dates Below) 
20.10 - Cardiac Rehabilitation Programs(RETIRED) 
20.10.1  Cardiac Rehabilitation Programs for Chronic Heart Failure 
20.11 - Intraoperative Ventricular Mapping 
20.12 - Diagnostic Endocardial Electrical Stimulation (Pacing) 
20.13 - HIS Bundle Study 
20.14 - Plethysmography 
20.15 - Electrocardiographic Services 
20.16 - Cardiac Output Monitoring By Thoracic Electrical Bioimpedance (TEB)  
Various Effective Dates Below 
20.17 - Noninvasive Tests of Carotid Function 
20.18 - Carotid Body Resection/Carotid Body Denervation 
20.19 - Ambulatory Blood Pressure Monitoring 
20.20 - External Counterpulsation (ECP) Therapy for Severe Angina (Effective 
March 20, 2006) 
20.21 - Chelation Therapy for Treatment of Atherosclerosis 
20.22 - Ethylenediamine-Tetra-Acetic (EDTA) Chelation Therapy for Treatment 
of Atherosclerosis 
20.23 - Fabric Wrapping of Abdominal Aneurysms 
20.24 - Displacement Cardiography 
20.25 - Cardiac Catheterization Performed in Other Than a Hospital Setting         
(RETIRED) 
20.26 - Partial Ventriculectomy 
20.27 - Cardiointegram (CIG) as an Alternative to Stress Test or Thallium Stress 
Test 
20.28  Therapeutic Embolization 
20.29  Hyperbaric Oxygen Therapy 
20.30 - Microvolt T-Wave Alternans (MTWA) 
20.31 - Intensive Cardiac Rehabilitation (ICR) Programs 
20.31.1 - Pritikin Program (Effective August 12, 2010) 
20.31.2 - Ornish Program for Reversing Heart Disease (Effective August 
12, 2010 
20.31.3  Benson-Henry Institute Cardiac Wellness Program (Effective 
May 6, 2014) 
20.32  Transcatheter Aortic Valve Replacement (TAVR) 
20.33 - Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve Regurgitation 
20.34 - Percutaneous Left Atrial Appendage Closure (LAAC) 
20.35 - Supervised Exercise Therapy (SET) for Symptomatic Peripheral Artery 
  Disease (PAD)  30 - Complementary and Alternative Medicine 
30.1 - Biofeedback Therapy 
30.1.1 - Biofeedback Therapy for the Treatment of Urinary Incontinence 
30.2 - Thermogenic Therapy 
30.3 - Acupuncture 
30.3.1  Acupuncture for Fibromyalgia 
30.3.2  Acupuncture for Osteoarthritis 
30.3.3  Acupuncture for Chronic Lower Back Pain (cLBP) 
30.4 - Electrosleep Therapy (RETIRED) 
30.5 - Transcendental Meditation 
30.6 - Intravenous Histamine Therapy 
30.7 - Laetrile and Related Substances 
30.8 - Cellular Therapy 
30.9 - Transillumination Light Scanning, or Diaphanography 
40 - Endocrine System and Metabolism 
40.1 - Diabetes Outpatient Self-Management Training 
40.2 - Home Blood Glucose Monitors 
40.3 - Closed-Loop Blood Glucose Control Device (CBGCD) 
40.4 - Insulin Syringe 
40.5  Treatment of Obesity 
40.7 - Outpatient Intravenous Insulin Treatment (Effective December 23, 2009) 
50 - Ear, Nose and Throat (ENT) 
50.1 - Speech Generating Devices 
50.2 - Electronic Speech Aids 
50.3 - Cochlear Implantation (Effective April 4, 2005) 
50.4 - Tracheostomy Speaking Valve 
50.5 - Oxygen Treatment of Inner Ear/Carbon Therapy 
50.6 - Tinnitus Masking (RETIRED) 
50.7 - Cochleostomy With Neurovascular Transplant for Menieres Disease 
50.8 - Ultrasonic Surgery 
60 - Emergency Medicine 
70 - Evaluation and Management of Patients - Office/hospital/home 
70.1 - Consultations With a Beneficiarys Family and Associates 
70.2 - Consultation Services Rendered by a Podiatrist in a Skilled Nursing 
Facility 
70.3 - Physicians Office Within an Institution - Coverage of Services and 
Supplies Incident to a Physicians Services 
70.4 - Pronouncement of Death 
70.5 - Hospital and Skilled Nursing Facility Admission Diagnostic Procedures  80 - Eye 
80.1 - Hydrophilic Contact Lens for Corneal Bandage 
80.2 - Photodynamic Therapy 
80.2.1 - Ocular Photodynamic Therapy (OPT) - Effective April 3, 2013 
80.3 - Photosensitive Drugs 
80.3.1 - Verteporfin - Effective April 3, 2013 
80.4 - Hydrophilic Contact Lenses 
80.5 - Scleral Shell 
80.6 - Intraocular Photography 
80.7 - Refractive Keratoplasty 
80.7.1 - Keratoplasty 
80.8 - Endothelial Cell Photography 
80.9 - Computer Enhanced Perimetry 
80.10 - Phaco-Emulsification Procedure - Cataract Extraction 
80.11 - Vitrectomy 
80.12 - Intraocular Lenses (IOLs)  Foreword - Purpose for National Coverage Determinations (NCD) 
Manual 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
A. Purpose 
 
The statutory and policy framework within which National Coverage Determinations 
(NCDs) are made may be found in title XVIII of the Social Security Act (the Act), and in 
Medicare regulations and rulings. The NCD Manual describes whether specific medical 
items, services, treatment procedures, or technologies can be paid for under Medicare.  
NCDs have been made on the items addressed in this manual. Decisions that 
items/services are not covered are generally based on 1862(a)(1) of the Act (the not 
reasonable and necessary exclusion) unless otherwise specifically noted. Where another 
statutory authority for denial is indicated, that is the authority for denial.  Where an 
item/service is stated to be covered, but such coverage is explicitly limited to specified 
indications or specified circumstances, all limitations on coverage of the items/services 
because they do not meet those specified indications or circumstances are based on 
1862(a)(1) of the Act. Where coverage of an item/service is provided for specified 
indications or circumstances but is not explicitly excluded for others, or where the 
item/service is not mentioned at all in the Centers for Medicare & Medicaid Services 
(CMS) NCD Manual the Medicare Administrative Contractor (MAC) has the discretion 
to make the coverage decision, in consultation with its medical staff, and with CMS when 
appropriate, based on the law, regulations, rulings, and general program instructions 
 
The coverage determinations in the manual will be revised based on the most recent 
medical and other scientific and technical evidence available to CMS. 
 
Other manuals in this system in which coverage-related instructions may be found are:  
 
Pub 100-02 (Benefit Policy); 
Pub 100-04 (Claims Processing); 
Pub 100-05 (Medicare Secondary Payer); and 
Pub 100-08 (Program Integrity) 
 
These manuals usually contain more general coverage descriptions and/or claims 
processing instructions. There should be no inconsistencies among the instructions in any 
of these manuals and the NCD Manual pertaining to coverage. If any such inconsistencies 
are found, bring them to the attention of CMS, Center for Clinical Standards and Quality, 
Coverage and Analysis Group, Division of Operations and Information Management. 
 
B. Organization 
 
The NCD Manual is organized by categories, e.g., medical procedures, supplies, 
diagnostic services.  A table of contents is provided at the beginning of the manual  designating coverage determination categories.  Each subject discussed within the 
category is listed and identified by a number. 
 
The revision transmittal sheet identifies new material and summarizes the principal 
changes.  When a change in policy or procedure is involved, the background and 
effective date for the change is provided.  If, at a later date, the reader wishes to refer to 
the background explanation given on a transmittal sheet, the reader can identify the 
transmittal by its number which appears on each manual page. 
 
C. CMS Coverage Web site 
 
The CMS Coverage Web page http://www.cms.gov/Center/Special-Topic/Medicare-
Coverage-Center.html?redirect=/center/coverage.asp contains information about pending 
NCDs and also provides access to a database of NCDs, National Coverage Analyses, and 
Local Medical review Policies. 
 
10 - Anesthesia and Pain Management 
(Rev. 1, 10-03-03) 
 
10.1 - Use of Visual Tests Prior to and General Anesthesia During 
Cataract Surgery 
A.  Pre-Surgery Evaluations 
 
Cataract surgery with an intraocular lens (IOL) implant is a high volume Medicare 
procedure.  Along with the surgery, a substantial number of preoperative tests are 
available to the surgeon.  In most cases, a comprehensive eye examination (ocular history 
and ocular examination) and a single scan to determine the appropriate pseudophakic 
power of the IOL are sufficient.  In most cases involving a simple cataract, a diagnostic 
ultrasound A-scan is used.  For patients with a dense cataract, an ultrasound B-scan may 
be used. 
 
Accordingly, where the only diagnosis is cataract(s), Medicare does not routinely cover 
testing other than one comprehensive eye examination (or a combination of a 
brief/intermediate examination not to exceed the charge of a comprehensive examination) 
and an A-scan or, if medically justified, a B-scan.  Claims for additional tests are denied 
as not reasonable and necessary unless there is an additional diagnosis and the medical 
need for the additional tests is fully documented. 
 
Because cataract surgery is an elective procedure, the patient may decide not to have the 
surgery until later, or to have the surgery performed by a physician other than the 
diagnosing physician.  In these situations, it may be medically appropriate for the 
operating physician to conduct another examination.  To the extent the additional tests are 
considered reasonable and necessary by the A/B MAC's medical staff, they are covered. 
 
B.  General Anesthesia 
  The use of general anesthesia in cataract surgery may be considered reasonable and 
necessary if, for particular medical indications, it is the accepted procedure among 
ophthalmologists in the local community to use general anesthesia. 
 
10.2 - Transcutaneous Electrical Nerve Stimulation (TENS) for Acute 
Post-Operative Pain 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
The use of transcutaneous electrical nerve stimulation (TENS) for the relief of acute post-
operative pain is covered under Medicare.  TENS may be covered whether used as an 
adjunct to the use of drugs, or as an alternative to drugs, in the treatment of acute pain 
resulting from surgery. 
 
The TENS devices, whether durable or disposable, may be used in furnishing this service. 
When used for the purpose of treating acute post-operative pain, TENS devices are 
considered supplies.  As such they may be hospital supplies furnished inpatients covered 
under Part A, or supplies incident to a physicians service when furnished in connection 
with surgery done on an outpatient basis, and covered under Part B. 
 
It is expected that TENS, when used for acute post-operative pain, will be necessary for 
relatively short periods of time, usually 30 days or less.  In cases when TENS is used for 
longer periods, A/B MACs should attempt to ascertain whether TENS is no longer being 
used for acute pain but rather for chronic pain, in which case the TENS device may be 
covered as durable medical equipment as described in 160.27. 
 
Cross-references: 
Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 40; 
Medicare Benefit Policy Manual, Chapter 2, Hospital Services Covered Under Part B, 
20, 20.4, and 80; Medicare Benefit Policy Manual, Chapter 15, Covered Medical and 
other Health Services, 110. 
 
10.3 - Inpatient Hospital Pain Rehabilitation Programs 
(Rev. 1, 10-03-03) 
CIM 35-21 
 
Pain rehabilitation programs are an innovative approach to the treatment of intractable 
pain.  The goal of such programs is to give a patient the tools to manage and control 
his/her pain and thereby improve his/her ability to function independently. 
 
A hospital level pain rehabilitation program is one that employs a coordinated multi-
disciplinary team to deliver, in a controlled environment, a concentrated program that is 
designed to modify pain behavior through the treatment of the physiological, 
psychological, and social aspects of pain.  Such programs generally include diagnostic 
testing, skilled nursing, psychotherapy, structured progressive withdrawal from pain 
medications, physical therapy, and occupational therapy to restore physical fitness  (mobility and endurance) to a maximal level within the constraints of a patients physical 
disability, and the use of mechanical devices, and/or activities to relieve pain or modify a 
patients reaction to it (e.g., nerve stimulator, hydrotherapy, massage, ice, systemic 
muscle relaxation training, and diversional activities). 
 
The nurses responsibility in such pain rehabilitation programs is to observe and assess, 
on a continuing basis, a patients condition and response to the program as reflected by 
his actions while in the nursing unit, and to assure that the atmosphere within the unit is 
not supportive of pain behavior. The day-to-day activities involved in carrying out the 
program are under the general supervision and, as needed, direct supervision of a 
physician. 
 
Since pain rehabilitation programs of a lesser scope than that described above would raise 
a question as to whether the program could be provided in a less intensive setting than on 
an inpatient hospital basis, carefully evaluate such programs to determine whether the 
program does, in fact, necessitate a hospital level of care.  Some pain rehabilitation 
programs may utilize services and devices which are excluded from coverage, e.g., 
acupuncture dorsal column stimulator, and family counseling services.  In determining 
whether the scope of a pain program does necessitate inpatient hospital care, evaluate 
only those services and devices which are covered.  Although diagnostic tests may be an 
appropriate part of pain rehabilitation programs, such tests would be covered in an 
individual case only where they can be reasonably related to a patients illness, 
complaint, symptom, or injury and where they do not represent an unnecessary 
duplication of tests previously performed. 
 
An inpatient program of 4 weeks duration is generally required to modify pain behavior. 
After this period, it would be expected that any additional rehabilitation services which 
might be required could be effectively provided on an outpatient basis under an 
outpatient pain rehabilitation program (see 10.4) or other outpatient program.  The first 
7-10 days of such an inpatient program constitute, in effect, an evaluation period.  If a 
patient is unable to adjust to the program within this period, it is generally concluded that 
it is unlikely that the program will be effective and the patient is discharged from the 
program.  On occasions, a program longer than four weeks may be required in a 
particular case.  In such a case, there should be documentation to substantiate that 
inpatient care beyond a 4-week period was reasonable and necessary.  Similarly, where it 
appears that a patient participating in a program is being granted frequent outside passes, 
a question would exist as to whether an inpatient program is reasonable and necessary for 
the treatment of the patients condition. 
 
An inpatient hospital stay for the purpose of participating in a pain rehabilitation program 
would be covered as reasonable and necessary to the treatment of a patients condition 
where the pain is attributable to a physical cause, the usual methods of treatment have not 
been successful in alleviating it, and a significant loss of ability to function independently 
has resulted from the pain. Chronic pain patients often have psychological problems 
which accompany or stem from the physical pain, and it is appropriate to include 
psychological treatment in the multi-disciplinary approach. However, patients whose pain  symptoms result from a mental condition, rather than from any physical cause, generally 
cannot be successfully treated in a pain rehabilitation program. 
 
10.4 - Outpatient Hospital Pain Rehabilitation Programs 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
Some hospitals also provide pain rehabilitation programs for outpatients.  In such 
programs, services frequently are provided in group settings even though they are being 
furnished pursuant to each patients individualized plan of treatment. 
 
Coverage of services furnished under outpatient hospital pain rehabilitation programs, 
including services furnished in group settings under individualized plans of treatment, is 
available if the patients pain is attributable to a physical cause, the usual methods of 
treatment have not been successful in alleviating it, and a significant loss of ability by the 
patient to function independently has resulted from the pain.  If a patient meets these 
conditions and the program provides services of the types discussed in 10.3, the services 
provided under the program may be covered.  Non-covered services (e.g., vocational 
counseling, meals for outpatients, or acupuncture) continue to be excluded from 
coverage, and A/B MACs would not be precluded from finding, in the case of particular 
patients, that the pain rehabilitation program is not reasonable and necessary under 
1862(a)(1) of the Social Security Act for the treatment of their conditions. 
 
10.5 - Autogenous Epidural Blood Graft 
(Rev. 1, 10-03-03) 
CIM 45-11 
 
Autogenous epidural blood grafts are considered a safe and effective remedy for severe 
headaches that may occur after performance of spinal anesthesia, spinal taps or 
myelograms, and are covered.  In the procedure, blood is removed from the patients vein 
and injected into his epidural space, to seal the spinal fluid leak and stop the pain. 
 
10.6 - Anesthesia in Cardiac Pacemaker Surgery 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
The use of general or monitored anesthesia during transvenous cardiac pacemaker 
surgery may be reasonable and necessary and therefore covered under Medicare only if 
adequate documentation of medical necessity is provided on a case-by-case basis.  The 
A/B MAC obtains advice from its medical consultants or from appropriate specialty 
physicians or groups in its locality regarding the adequacy of documentation before 
deciding whether a particular claim should be covered. 
 
A second type of pacemaker surgery that is sometimes performed involves the use of the 
thoracic method of implantation which requires open surgery.  Where the thoracic 
method is employed, general anesthesia is always used and should not require special  medical documentation. 
 
20 - Cardiovascular System 
(Rev. 1, 10-03-03) 
 
20.1 - Vertebral Artery Surgery 
(Rev. 1, 10-03-03) 
CIM 35-32 
 
Obstructions which block the flow of blood through the vertebral artery can cause 
vertigo, visual or speech defects, ataxia, mental confusion, or stroke.  These symptoms in 
patients result from reduction in blood flow to the brain and range from symptoms of 
transient basilar ischemia to mental deterioration or completed stroke. 
 
Five types of surgical procedures are performed to relieve obstructions to vertebral artery 
blood flow.  They are: 
 
  Vertebral artery endarterectomy, a procedure which cleans out arteriosclerotic 
plaques which are inside the vertebral artery; 
 
  Vertebral artery by-pass or resection with anastomosis or graft; 
 
  Subclavian artery resection with or without endarterectomy; 
 
  Removal of laterally located osteophytes anywhere in the C6 (C7)-C2 course of 
the vertebral artery; and 
 
  Arteriolysis which frees the artery from surrounding tissue, with or without 
arteriopexy (fixation of the vessel). 
 
These procedures can be medically reasonable and necessary, but only if each of the 
following conditions is met: 
 
  Symptoms of vertebral artery obstruction exist; 
 
  Other causes have been considered and ruled out; 
 
  There is radiographic evidence of a valid vertebral artery obstruction; and  
 
  Contraindications to the procedure do not exist, such as coexistent obstructions of 
multiple cerebral vessels. 
 
Angiograms documenting a valid obstruction should show not only the aortic arch with 
the vessels off the arch, but also show the vessels in the neck and head (providing biplane 
views of the carotid and vertebral vascular system).  In addition, serial views are needed 
to diagnose subclavian steal, the condition in which subclavian artery obstruction  causes the symptoms of vertebral artery obstruction.  Because the symptoms are not 
specific for vertebral artery obstruction, other causes must be considered.  In addition to 
vertebral artery obstruction, the differential diagnosis should include various degenerative 
disorders of the brain, orthostatic hypotension, acoustic neuroma, labyrinthitis, diabetes 
mellitus and hypoglycemia related disorders. 
 
Obstructions which can cause symptoms of blocked vertebral artery blood flow and 
which can be documented by an angiogram include: 
 
  Intravascular obstructions - arteriosclerotic lesions within the vertebral artery or in 
other arteries. 
 
  Extravascular obstructions; 
 
  Bony tissue or osteophytes, located laterally in the C6 (C7)-C2 cervical vertebral 
area course of the vertebral artery, most commonly at C5 -C6; 
 
  Anatomical variations - Anomalous location of the origin of the vertebral artery, a 
congenital aberration, and tortuosity and kinks of the vertebral artery; to 
 
  Fibrous tissue - Tissue changed as a result of manipulation of the neck for neck 
pain or injury associated with hematoma; external bands, tendinous slings, and fibrous 
bands. 
 
The most controversial obstructions include vertebral artery tortuosity and kinks and 
connective tissue along the course of the vertebral artery, and variously called external 
bands, tendinous slings and fibrous bands.  In the absence of symptoms of vertebral 
artery obstruction, vascular surgeons feel such abnormalities are insignificant.  Vascular 
surgery experts, however, agree that these abnormalities in very rare cases do cause 
symptoms of vertebral artery obstruction and do necessitate surgical correction. 
 
Vertebral artery construction and vertebral artery surgery are phrases which most 
physicians interpret to include only surgical cleaning (endarterectomy) and bypass 
(resection) procedures.  However, some physicians who use these terms mean all 
operative manipulations which remove vertebral artery blood flow obstructions.  Also, 
some physicians use general terms of vascular surgery, such as endarterectomy, when 
vertebral artery related surgery is performed.  Use of the above terminology specifies 
neither the surgical procedure performed nor its relationship to the vertebral artery.  
Therefore, in developing claims for this type of procedure, require specific identification 
of the obstruction in question and the surgical procedure performed.  Also, in view of the 
specific coverage criteria given, develop all claims for vertebral artery surgery on a case-
by-case basis. 
 
Make payment for a surgical procedure listed above if: (1) it is reasonable and necessary 
for the individual patient to have the surgery performed to remove or relieve an 
obstruction to vertebral artery flow, and (2) the four conditions noted are met.   
In all other cases, these procedures cannot be considered reasonable and necessary within 
the meaning of 1862(a)(1) of the Act and are not reimbursable under the program. 
 
20.2 - Extracranial - Intracranial (EC-IC) Arterial Bypass Surgery 
(Rev. 1, 10-03-03) 
CIM 35-37 
 
Extracranial-Intracranial (EC-IC) arterial bypass surgery is not a covered procedure when 
it is performed as a treatment for ischemic cerebrovascular disease of the carotid or 
middle cerebral arteries which includes the treatment or prevention of strokes.  The 
premise that this procedure which bypasses narrowed arterial segments, improves the 
blood supply to the brain and reduces the risk of having a stroke has not been 
demonstrated to be any more effective than no surgical intervention.  Accordingly, EC-IC 
arterial bypass surgery is not considered reasonable and necessary within the meaning of 
1862(a)(1) of the Act when it is performed as a treatment for ischemic cerebrovascular 
disease of the carotid or middle cerebral arteries. 
 
20.3 - Thoracic Duct Drainage (TDD) in Renal Transplants 
(Rev. 1, 10-03-03) 
CIM 35-58 
 
Thoracic duct drainage (TDD) is an immunosuppressive technique used in renal 
transplantation.  This procedure which removes lymph from kidney transplant recipients 
as a means of achieving suppression of the immune mechanism, is currently being used 
both pre- and post-transplant in conjunction with more conventional immunotherapy.  
TDD is performed on an inpatient basis, and the inpatient stay is covered for patients 
admitted for treatment in advance of a kidney transplant as well as for those receiving it 
post-transplant. 
 
The TDD is a covered technique when furnished to a kidney transplant recipient or an 
individual approved to receive kidney transplantation in a hospital approved to perform 
kidney transplantation. 
 
20.4  Implantable Cardioverter Defibrillators (ICDs) 
(Rev. 12112; Issued: 06-29-23; Effective: 07- 31-23; Implementation: 07-31- 23) 
 
A. General 
 
An implantable cardioverter defibrillator (ICD) is an electronic device designed to 
diagnose and treat life-threatening ventricular tachyarrhythmias.   
 
B. Nationally Covered Indications 
  Effective for services performed on or after February 15, 2018 CMS has determined that 
the evidence is sufficient to conclude that the use of ICDs, (also referred to as 
defibrillators) is reasonable and necessary: 
 
1.  Patients with a personal history of sustained ventricular tachyarrhythmia (VT) 
or cardiac arrest due to ventricular fibrillation (VF).  Patients must have 
demonstrated: 
  An episode of sustained VT, either spontaneous or induced by an 
electrophysiology (EP) study, not associated with an acute myocardial 
infarction (MI) and not due to a transient or reversible cause; or 
  An episode of cardiac arrest due to VF, not due to a transient or 
reversible cause. 
 
2.  Patients with a prior MI and a measured left ventricular ejection fraction 
(LVEF)  0.30.  Patients must not have:  
  New York Heart Association (NYHA) classification IV heart failure; 
or, 
  Had a coronary artery bypass graft (CABG), or percutaneous coronary 
intervention (PCI) with angioplasty and/or stenting, within the past 3 
months; or, 
  Had an MI within the past 40 days; or, 
  Clinical symptoms and findings that would make them a candidate for 
coronary revascularization. 
 
For these patients identified in B2, a formal shared decision making encounter 
must occur between the patient and a physician (as defined in Section 
1861(r)(1) of the Social Security Act (the Act))or qualified non-physician 
practitioner (meaning a physician assistant, nurse practitioner, or clinical 
nurse specialist as defined in 1861(aa)(5) of the Act) using an evidence-
based decision tool on ICDs prior to initial ICD implantation.  The shared 
decision making encounter may occur at a separate visit. 
 
3.  Patients who have severe, ischemic, dilated cardiomyopathy but no personal 
history of sustained VT or cardiac arrest due to VF, and have NYHA Class II 
or III heart failure, LVEF < 35%.  Additionally, patients must not have: 
  Had a CABG, or PCI with angioplasty and/or stenting, within the past 
3 months; or, 
  Had an MI within the past 40 days; or, 
  Clinical symptoms and findings that would make them a candidate for 
coronary revascularization. 
  For these patients identified in B3, a formal shared decision making encounter 
must occur between the patient and a physician (as defined in Section 
1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a 
physician assistant, nurse practitioner, or clinical nurse specialist as defined in 
1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior 
to initial ICD implantation.  The shared decision making encounter may occur 
at a separate visit. 
 
4.  Patients who have severe, non-ischemic, dilated cardiomyopathy but no 
personal history of sustained VT or cardiac arrest due to VF, and have 
NYHA Class II or III heart failure, LVEF < 35%, been on optimal medical 
therapy for at least 3 months.  Additionally, patients must not have: 
  Had a CABG or PCI with angioplasty and/or stenting, within the past 
3 months; or, 
  Had an MI within the past 40 days; or, 
  Clinical symptoms and findings that would make them a candidate for 
coronary revascularization. 
 
For these patients identified in B4, a formal shared decision making encounter 
must occur between the patient and a physician (as defined in Section 
1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a 
physician assistant, nurse practitioner, or clinical nurse specialist as defined in 
1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior 
to initial ICD implantation.  The shared decision making encounter may occur 
at a separate visit. 
 
5.  Patients with documented, familial or genetic disorders with a high risk of 
life-threatening tachyarrhythmias (sustained VT or VF), to include, but not 
limited to, long QT syndrome or hypertrophic cardiomyopathy. 
 
For these patients identified in B5, a formal shared decision making encounter 
must occur between the patient and a physician (as defined in Section 
1861(r)(1) of the Act) or qualified non-physician practitioner (meaning a 
physician assistant, nurse practitioner, or clinical nurse specialist as defined in 
1861(aa)(5) of the Act) using an evidence-based decision tool on ICDs prior 
to initial ICD implantation.  The shared decision making encounter may occur 
at a separate visit. 
 
6.  Patients with an existing ICD may receive an ICD replacement if it is required 
due to the end of battery life, elective replacement indicator (ERI), or 
device/lead malfunction. 
  For each of the 6 covered indications above, the following additional criteria must also be 
met: 
 
1.  Patients must be clinically stable (e.g., not in shock, from any etiology); 
2.  LVEF must be measured by echocardiography, radionuclide (nuclear 
medicine) imaging, cardiac magnetic resonance imaging (MRI), or catheter 
angiography; 
3.  Patients must not have: 
 
  Significant, irreversible brain damage; or, 
  Any disease, other than cardiac disease (e.g., cancer, renal failure, liver 
failure) associated with a likelihood of survival less than 1 year; or, 
  Supraventricular tachycardia such as atrial fibrillation with a poorly 
controlled ventricular rate. 
 
Exceptions to waiting periods for patients that have had a CABG, or PCI with 
angioplasty and/or stenting, within the past 3 months, or had an MI within the past 40 
days: 
 
Cardiac Pacemakers:  Patients who meet all CMS coverage requirements for 
cardiac pacemakers, and who meet the criteria in this national coverage 
determination for an ICD, may receive the combined devices in one procedure, at 
the time the pacemaker is clinically indicated; 
 
Replacement of ICDs:  Patients with an existing ICD may receive an ICD 
replacement if it is required due to the end of battery life, ERI, or device/lead 
malfunction. 
 
C. Nationally Non-Covered Indications 
 
N/A 
 
D.  Other 
 
For patients that are candidates for heart transplantation on the United Network for Organ 
Sharing (UNOS) transplant list awaiting a donor heart, coverage of ICDs, as with cardiac 
resynchronization therapy, as a bridge-to-transplant to prolong survival until a donor 
becomes available, is determined by the local Medicare Administrative Contractors 
(MACs).   
 
All other indications for ICDs not currently covered in accordance with this decision may 
be covered under Category B investigational device exemption (IDE) trials (42 CFR 
405.201). 
 
(This NCD last reviewed February 2018.)   
20.5 - Extracorporeal Immunoadsorption (ECI) Using Protein A 
Columns (RETIRED) 
(Rev. 11892; Issued: 03-09-23; Effective: 04-10-23; Implementation:04-10-23)   
 
Effective January 1, 2021, the Centers for Medicare & Medicaid Services determined that 
no national coverage determination (NCD) is appropriate at this time for Extracorporeal 
Immunoadsorption (ECI) Using Protein A Columns. In the absence of an NCD, coverage  
determinations will be made by the Medicare Administrative Contractors under  
1862(a)(1)(A) of the Social Security Act. 
 
20.6 - Transmyocardial Revascularization (TMR) 
(Rev. 1, 10-03-03) 
CIM 35-94 
 
Transmyocardial revascularization (TMR) is a surgical technique which uses a laser to 
bore holes through the myocardium of the heart in an attempt to restore perfusion to areas 
of the heart not being reached by diseased or clogged arteries.  This technique is used as a 
late or last resort for relief of symptoms of severe angina in patients with ischemic heart 
disease not amenable to direct coronary revascularization interventions, such as 
angioplasty, stenting or open coronary bypass. 
 
The precise workings of this technique are not certain.  The original theory upon which 
the technique was based, that the open channels would result in increased perfusion of the 
myocardium, does not appear to be the major or only action at work.  Several theories 
have been proposed, including partial denervation of the myocardium, or the triggering of 
the cascade of biological reactions which encourage increased development of blood 
vessels. 
 
However, research at several facilities indicates that, despite this uncertainty, the 
technique does offer relief of angina symptoms for a period of time in patients for whom 
no other medical treatment offering relief is available.  Studies indicate that both 
reduction in pain and reduction in hospitalizations are significant for most patients 
treated.  Consequently, CMS has concluded that, for patients with severe angina (Class 
III or IV, Canadian Cardiovascular Society, or similar classification system) for whom all 
other medical therapies have been tried or evaluated and found insufficient, such therapy 
offers sufficient evidence of its medical effectiveness to treat the symptomatology.  It is 
important to note that this technique does not provide for increased life expectancy, nor is 
it proven to affect the underlying cause of the angina.  However, it appears effective in 
treating the symptoms of angina, and reducing hospitalizations and allowing patients to 
resume some of their normal activities of daily living. 
 
The CMS therefore covers TMR as a late or last resort for patients with severe (Canadian 
Cardiovascular Society classification Classes III or IV) angina (stable or unstable) which 
has been found refractory to standard medical therapy, including drug therapy at the 
maximum tolerated or maximum safe dosages.  In addition, the angina symptoms must be  caused by areas of the heart not amenable to surgical therapies such as percutaneous 
transluminal coronary angioplasty, stenting, coronary atherectomy or coronary bypass. 
 
Coverage is further limited to those uses of the laser used in performing the procedure 
which have been approved by the Food and Drug Administration for the purpose for 
which they are being used. 
 
Patients would have to meet all of the following additional selection guidelines: 
 
  An ejection fraction of 25 percent or greater; 
 
  Have areas of viable ischemic myocardium (as demonstrated by diagnostic study) 
which are not capable of being revascularized by direct coronary intervention; and 
 
  Have been stabilized, or have had maximal efforts to stabilize acute conditions 
such as severe ventricular arrhythmias, decompensated congestive heart failure or acute 
myocardial infarction. 
 
Coverage is limited to physicians who have been properly trained in the procedure.  
Providers of this service must also document that all ancillary personnel, including 
physicians, nurses, operating room personnel and technicians, are trained in the procedure 
and the proper use of the equipment involved.  Coverage is further limited to providers 
which have dedicated cardiac care units, including the diagnostic and support services 
necessary for care of patients undergoing this therapy.  In addition, these providers must 
conform to the standards for laser safety set by the American National Standards 
Institute, ANSIZ1363. 
 
20.7 - Percutaneous Transluminal Angioplasty (PTA) (Various Effective 
Dates Below) 
(Rev. 212, Issued: 01-19-19, Effective: 02-19-19, Implementation: 02-19-19) 
 
The term Medicare beneficiary identifier (Mbi) is a general term describing a 
beneficiarys Medicare identification number. For purposes of this manual, Medicare 
beneficiary identifier references both the Health Insurance Claim Number (HICN) and 
the Medicare Beneficiary Identifier (MBI) during the new Medicare card transition 
period and after for certain business areas that will continue to use the HICN as part of 
their processes. 
 
A.  General 
 
This procedure involves inserting a balloon catheter into a narrow or occluded blood 
vessel to recanalize and dilate the vessel by inflating the balloon.  The objective of 
percutaneous transluminal angioplasty (PTA) is to improve the blood flow through the 
diseased segment of a vessel so that vessel patency is increased and embolization is 
decreased.  With the development and use of balloon angioplasty for treatment of 
atherosclerotic and other vascular stenoses, PTA (with and without the placement of a  stent) is a widely used technique for dilating lesions of peripheral, renal, and coronary 
arteries. 
 
Indications and Limitations of Coverage 
 
B.  Nationally Covered Indications 
 
The PTA is covered when used under the following conditions: 
 
1.  Treatment of Atherosclerotic Obstructive Lesions 
 
-In the lower extremities, i.e., the iliac, femoral, and popliteal arteries, or in the upper 
extremities, i.e., the innominate, subclavian, axillary, and brachial arteries. The upper 
extremities do not include head or neck vessels.  
 
-Of a single coronary artery for patients for whom the likely alternative treatment is 
coronary bypass surgery and who exhibit the following characteristics:  
 
  Angina refractory to optimal medical management;  
  Objective evidence of myocardial ischemia; and  
  Lesions amenable to angioplasty.  
 
-Of the renal arteries for patients in whom there is an inadequate response to a thorough 
medical management of symptoms and for whom surgery is the likely alternative. PTA 
for this group of patients is an alternative to surgery, not simply an addition to medical 
management.  
 
-Of arteriovenous dialysis fistulas and grafts when performed through either a venous or 
arterial approach. 
 
2.  Concurrent with Carotid Stent Placement in Food and Drug Administration 
(FDA)-Approved Category B Investigational Device Exemption (IDE) Clinical 
Trials 
 
Effective July 1, 2001, Medicare covers PTA of the carotid artery concurrent with carotid 
stent placement when furnished in accordance with the FDA-approved protocols 
governing Category B IDE clinical trials. PTA of the carotid artery, when provided solely 
for the purpose of carotid artery dilation concurrent with carotid stent placement, is 
considered to be a reasonable and necessary service when provided in the context of such 
a clinical trial. 
 
3.  Concurrent with Carotid Stent Placement in FDA-Approved Post-Approval 
Studies 
 
Effective October 12, 2004, Medicare covers PTA of the carotid artery concurrent with 
the placement of an FDA-approved carotid stent and an FDA-approved or cleared  embolic protection device (effective December 9, 2009) for an FDA-approved indication 
when furnished in accordance with FDA-approved protocols governing post-approval 
studies. The Centers for Medicare & Medicaid Services (CMS) determines that coverage 
of PTA of the carotid artery is reasonable and necessary in these circumstances. 
 
4.  Concurrent with Carotid Stent Placement in Patients at High Risk for Carotid 
Endarterectomy (CEA) 
 
Effective March 17, 2005, Medicare covers PTA of the carotid artery concurrent with the 
placement of an FDA-approved carotid stent with embolic protection for the following:  
 
  Patients who are at high risk for CEA and who also have symptomatic carotid 
artery stenosis 70%.  Coverage is limited to procedures performed using FDA-
approved carotid artery stenting (CAS) systems and FDA-approved or -cleared 
(effective December 9, 2009) embolic protection devices.  If deployment of the 
embolic protection device is not technically possible, and not performed, then the 
procedure is not covered by Medicare (effective December 9, 2009); 
 
  Patients who are at high risk for CEA and have symptomatic carotid artery 
stenosis between 50% and 70%, in accordance with the Category B IDE clinical 
trials regulation (42 CFR 405.201), as a routine cost under the clinical trials 
policy (Medicare National Coverage Determination (NCD) Manual 310.1), or in 
accordance with the NCD on CAS post-approval studies (Medicare NCD Manual 
20.7); 
 
  Patients who are at high risk for CEA and have asymptomatic carotid artery 
stenosis 80%, in accordance with the Category B IDE clinical trials regulation 
(42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare 
NCD Manual 310.1), or in accordance with the NCD on CAS post-approval 
studies (Medicare NCD Manual 20.7). 
 
Coverage is limited to procedures performed using an FDA-approved CAS, stents and 
FDA-approved or -cleared embolic protection devices. 
 
The use of an FDA-approved or cleared embolic protection device is required. If 
deployment of the embolic protection device is not technically possible, and not 
performed, then the procedure is not covered by Medicare. 
 
Patients at high risk for CEA are defined as having significant comorbidities and/or 
anatomic risk factors (i.e., recurrent stenosis and/or previous radical neck dissection), and 
would be poor candidates for CEA. Significant comorbid conditions include but are not 
limited to:  
 
  Congestive heart failure (CHF) class III/IV; 
  Left ventricular ejection fraction (LVEF) <30%; 
  Unstable angina;    Contralateral carotid occlusion; 
  Recent myocardial infarction (MI); 
  Previous CEA with recurrent stenosis; 
  Prior radiation treatment to the neck; and, 
  Other conditions that were used to determine patients at high risk for CEA in the 
prior carotid artery stenting trials and studies, such as ARCHER, CABERNET, 
SAPPHIRE, BEACH, and MAVERIC II. 
 
Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct 
focal neurological dysfunction persisting less than 24 hours), focal cerebral ischemia 
producing a non-disabling stroke (modified Rankin scale <3 with symptoms for 24 hours 
or more), and transient monocular blindness (amaurosis fugax). Patients who have had a 
disabling stroke (modified Rankin scale 3) shall be excluded from coverage. 
 
The determination that a patient is at high risk for CEA and the patients symptoms of 
carotid artery stenosis shall be available in the patient medical records prior to 
performing any procedure. 
 
The degree of carotid artery stenosis shall be measured by duplex Doppler ultrasound or 
carotid artery angiography and recorded in the patients medical records. If the stenosis is 
measured by ultrasound prior to the procedure, then the degree of stenosis must be 
confirmed by angiography at the start of the procedure. If the stenosis is determined to be 
<70% by angiography, then CAS should not proceed. 
 
In addition, CMS has determined that CAS with embolic protection is reasonable and 
necessary only if performed in facilities that have been determined to be competent in 
performing the evaluation, procedure and follow-up necessary to ensure optimal patient 
outcomes. Standards to determine competency include specific physician training 
standards, facility support requirements and data collection to evaluate outcomes during a 
required reevaluation. 
 
The CMS has created a list of minimum standards modeled in part on professional 
society statements on competency. All facilities must at least meet CMSs standards in 
order to receive coverage for CAS for high-risk patients. 
 
  Facilities must have necessary imaging equipment, device inventory, staffing, and 
infrastructure to support a dedicated carotid stent program. Specifically, high-
quality x-ray imaging equipment is a critical component of any carotid 
interventional suite, such as high-resolution digital imaging systems with the 
capability of subtraction, magnification, road mapping, and orthogonal 
angulation. 
 
  Advanced physiologic monitoring must be available in the interventional suite. 
This includes real time and archived physiologic, hemodynamic, and cardiac 
rhythm monitoring equipment, as well as support staff who are capable of 
interpreting the findings and responding appropriately.   
  Emergency management equipment and systems must be readily available in the 
interventional suite such as resuscitation equipment, a defibrillator, vasoactive 
and antiarrhythmic drugs, endotracheal intubation capability, and anesthesia 
support. 
 
  Each institution shall have a clearly delineated program for granting carotid stent 
privileges and for monitoring the quality of the individual interventionalists and 
the program as a whole. The oversight committee for this program shall be 
empowered to identify the minimum case volume for an operator to maintain 
privileges, as well as the (risk-adjusted) threshold for complications that the 
institution will allow before suspending privileges or instituting measures for 
remediation. Committees are encouraged to apply published standards from 
national specialty societies recognized by the American Board of Medical 
Specialties to determine appropriate physician qualifications. Examples of 
standards and clinical competence guidelines include those published in the 
December 2004 edition of the American Journal of Neuroradiology, and those 
published in the August 18, 2004, Journal of the American College of Cardiology. 
 
  To continue to receive Medicare payment for CAS under this decision, the facility 
or a contractor to the facility must collect data on all CAS procedures done at that 
particular facility.  This data must be analyzed routinely to ensure patient safety. 
This data must be made available to CMS upon request. The interval for data 
analysis will be determined by the facility but shall not be less frequent than every 
6 months. 
 
Since there currently is no recognized entity that evaluates CAS facilities, CMS has 
established a mechanism for evaluating facilities. Facilities must provide written 
documentation to CMS that the facility meets one of the following:  
 
1.  The facility was an FDA-approved site that enrolled patients in prior CAS IDE 
trials, such as SAPPHIRE, and ARCHER;  
 
2.  The facility is an FDA-approved site that is participating and enrolling patients in 
ongoing CAS IDE trials, such as CREST;  
 
3.  The facility is an FDA-approved site for one or more FDA post approval studies; 
or,  
 
4.  The facility has provided a written affidavit to CMS attesting that the facility has 
met the minimum facility standards. This should be sent to:  
 
Director, Coverage and Analysis Group 
7500 Security Boulevard, Mailstop S3-02-01 
Baltimore, MD 21244 
  The letter must include the following information: 
 
  Facility's name and complete address;  
  Facility's national provider identifier (formerly referred to as the Medicare 
provider number);  
  Point-of-contact for questions with telephone number;  
  Discussion of how each standard has been met by the hospital;  
  Mechanism of data collection of CAS procedures; and,  
  Signature of a senior facility administrative official.  
 
A list of certified facilities will be made available and viewable at: 
http://www.cms.hhs.gov/coverage/carotid-stent-facilities.asp.  
In addition, CMS will publish a list of approved facilities in the Federal Register. 
 
Facilities must recertify every two (2) years in order to maintain Medicare coverage of 
CAS procedures. Recertification will occur when the facility documents that and 
describes how it continues to meet the CMS standards. 
 
The process for recertification is as follows: 
 
1.  At 23 months after initial certification: 
 
  Submission of a letter to CMS stating how the facility continues to meet the 
minimum facility standards as listed above. 
 
2.  At 27 months after initial certification: 
 
  Submission of required data elements for all CAS procedures performed on 
patients during the previous two (2) years of certification. 
 
  Data elements: 
 
a.  Patients Medicare beneficiary identifier if a Medicare beneficiary; 
b.  Patients date of birth; 
c.  Date of procedure; 
d.  Does the patient meet high surgical risk criteria (defined below)? 
 
  Age 80; 

  Recent (<30 days) MI; 

  LVEF <30%; 

  Contralateral carotid occlusion; 

  New York Heart Association (NYHA) Class III or IV congestive heart 

failure; 
  Unstable angina: Canadian Cardiovascular Society (CCS) Class III/IV; 

  Renal failure: end-stage renal disease on dialysis; 

  Common Carotid Artery (CCA) lesion(s) below clavicle; 
   Severe chronic lung disease; 

  Previous neck radiation; 

  High cervical Internal Carotid Artery (ICA) lesion(s); 

  Restenosis of prior CEA; 

  Tracheostomy; 

  Contralateral laryngeal nerve palsy. 

 
e.  Is the patient symptomatic (defined below)? 
 
  Carotid Transient Ischemic Attack (TIA) persisting less than 24 hours; 

  Non-disabling stroke: Modified Rankin Scale 

  Transient monocular blindness: amaurosis fugax. 

 
f.   Modified Rankin Scale score if the patient experienced a stroke. 
g.  Percent of stenosis of stented lesion(s) by angiography. 
h.  Was embolic protection used? 
i.  Were there any complications during hospitalization (defined below)? 
 
  All stroke: an ischemic neurologic deficit that persisted more than 24 
o
hours; 
  MI;  
o
  All death. 
o
 
Recertification is effective for two (2) additional years during which facilities will be 
required to submit the requested data every April 1 and October 1. 
 
The CMS will consider the approval of national CAS registries that provide CMS with a 
comprehensive overview of the registry and its capabilities, and the manner in which the 
registry meets CMS data collection and evaluation requirements. Specific standards for 
CMS approval are listed below. Facilities enrolled in a CMS-approved national CAS 
registry will automatically meet the data collection standards required for initial and 
continued facility certification. Hospitals contracts with an approved registry may 
include authority for the registry to submit required data to CMS for the hospital. A list of 
approved registries will be available on the CMS Coverage Web site. 
 
National Registries 
 
As noted above, CMS will approve national registries developed by professional societies 
and other organizations and allow these entities to collect and submit data to CMS on 
behalf of participating facilities to meet facility certification and recertification 
requirements. To be eligible to perform these functions and become a CMS-approved 
registry, the national registry, at a minimum, must be able to:  
 
1.  Enroll facilities in every U.S. state and territory; 
2.  Assure data confidentiality and compliance with HIPPA; 
3.  Collect the required CMS data elements as listed in the above section;  4.  Assure data quality and data completeness; 
5.  Address deficiencies in the facility data collection, quality, and submission; 
6.  Validate the data submitted by facilities as needed; 
7.  Track long term outcomes such as stroke and death; 
8.  Conduct data analyses and produce facility specific data reports and summaries; 
9.  Submit data to CMS on behalf of the individual facilities; and 
10.  Provide quarterly reports to CMS on facilities that do not meet or no longer 
meet the CMS facility certification and recertification requirements pertaining 
to data collection and analysis. 
 
Registries wishing to receive this designation from CMS must submit evidence that they 
meet or exceed our standards.  Though the registry requirements pertain to CAS, CMS 
strongly encourages all national registries to establish a similar mechanism to collect 
comparable data on CEA.  Having both CAS and CEA data will help answer questions 
about carotid revascularization, in general, in the Medicare population. 
 
The CAS for patients who are not at high risk for CEA remains covered only in FDA-
approved Category B IDE clinical trials under 42 CFR 405.201. 
 
The CMS has determined that PTA of the carotid artery concurrent with the placement of 
an FDA-approved carotid stent and an FDA-approved or cleared embolic protection 
device is not reasonable and necessary for all other patients. 
 
5.  Concurrent with Intracranial Stent Placement in FDA-Approved Category B 
IDE Clinical Trials 
 
Effective November 6, 2006, Medicare covers PTA and stenting of intracranial arteries 
for the treatment of cerebral artery stenosis 50% in patients with intracranial 
atherosclerotic disease when furnished in accordance with the FDA-approved protocols 
governing Category B IDE clinical trials.  CMS determines that coverage of intracranial 
PTA and stenting is reasonable and necessary under these circumstances.  
 
C.  Nationally Non-Covered Indications 
 
All other indications for PTA with or without stenting to treat obstructive lesions of the 
vertebral and cerebral arteries remain non-covered.  
 
All other indications for PTA without stenting for which CMS has not specifically 
indicated coverage remain non-covered. 
 
D.  Other 
 
Coverage of PTA with stenting not specifically addressed or discussed in this NCD is at 
local A/B MAC discretion. 
 
  20.8 - Cardiac Pacemakers (Various Effective Dates Below) 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
Cardiac pacemakers are self-contained, battery-operated units that send electrical 
stimulation to the heart.  They are generally implanted to alleviate symptoms of 
decreased cardiac output related to abnormal heart rate and/or rhythm.  Pacemakers are 
generally used for persistent, symptomatic second- or third-degree atrioventricular (AV) 
block and symptomatic sinus bradycardia. 
 
Cardiac pacemakers are covered as prosthetic devices under the Medicare program, 
subject to the following conditions and limitations.  While cardiac pacemakers have been 
covered under Medicare for many years, there were no specific guidelines for their use 
other than the general Medicare requirement that covered services be reasonable and 
necessary for the treatment of the condition.  Services rendered for cardiac pacing on or 
after the effective dates of this instruction are subject to these guidelines, which are based 
on certain assumptions regarding the clinical goals of cardiac pacing.  While some uses 
of pacemakers are relatively certain or unambiguous, many other uses require 
considerable expertise and judgment. 
 
Consequently, the medical necessity for permanent cardiac pacing must be viewed in the 
context of overall patient management.  The appropriateness of such pacing may be 
conditional on other diagnostic or therapeutic modalities having been undertaken.  
Although significant complications and adverse side effects of pacemaker use are 
relatively rare, they cannot be ignored when considering the use of pacemakers for 
dubious medical conditions, or marginal clinical benefit. 
 
These guidelines represent current concepts regarding medical circumstances in which 
permanent cardiac pacing may be appropriate or necessary.  As with other areas of 
medicine, advances in knowledge and techniques in cardiology are expected. 
Consequently, judgments about the medical necessity and acceptability of new uses for 
cardiac pacing in new classes of patients may change as more conclusive evidence 
becomes available.  This instruction applies only to permanent cardiac pacemakers, and 
does not address the use of temporary, non-implanted pacemakers. 
 
The two groups of conditions outlined below deal with the necessity for cardiac pacing 
for patients in general.  These are intended as guidelines in assessing the medical 
necessity for pacing therapies, taking into account the particular circumstances in each 
case.  However, as a general rule, the two groups of current medical concepts may be 
viewed as representing: 
 
Group I:  Single-Chamber Cardiac Pacemakers  a) conditions under which single 
chamber pacemaker claims may be considered covered without further claims 
development; and b) conditions under which single-chamber pacemaker claims would be 
denied unless further claims development shows that they fall into the covered category, 
or special medical circumstances exist of the sufficiency to convince the A/B MAC that 
the claim should be paid.   
Group II:  Dual-Chamber Cardiac Pacemakers - a) conditions under which dual-chamber 
pacemaker claims may be considered covered without further claims development, and b) 
conditions under which dual-chamber pacemaker claims would be denied unless further 
claims development shows that they fall into the covered categories for single- and dual-
chamber pacemakers, or special medical circumstances exist sufficient to convince the 
A/B MAC that the claim should be paid. 
 
The Centers for Medicare & Medicaid Services (CMS) opened the National Coverage 
Determination (NCD) on Cardiac Pacemakers to afford the public an opportunity to 
comment on the proposal to revise the language contained in the instruction.  The 
revisions transfer the focus of the NCD from the actual pacemaker implantation 
procedure itself to the reasonable and necessary medical indications that justify cardiac 
pacing.  This is consistent with our findings that pacemaker implantation is no longer 
considered routinely harmful or an experimental procedure. 
 
Group I:  Single-Chamber Cardiac Pacemakers (Effective March 16, 1983) 
 
A.  Nationally Covered Indications 
 
Conditions under which cardiac pacing is generally considered acceptable or necessary, 
provided that the conditions are chronic or recurrent and not due to transient causes such 
as acute myocardial infarction, drug toxicity, or electrolyte imbalance.  (In cases where 
there is a rhythm disturbance, if the rhythm disturbance is chronic or recurrent, a single 
episode of a symptom such as syncope or seizure is adequate to establish medical 
necessity.) 
 
1.  Acquired complete (also referred to as third-degree) AV heart block.  
 
2.  Congenital complete heart block with severe bradycardia (in relation to age), or 
significant physiological deficits or significant symptoms due to the bradycardia. 
 
3.  Second-degree AV heart block of Type II (i.e., no progressive prolongation of P-R 
interval prior to each blocked beat.  P-R interval indicates the time taken for an impulse 
to travel from the atria to the ventricles on an electrocardiogram). 
 
4.  Second-degree AV heart block of Type I (i.e., progressive prolongation of P-R 
interval prior to each blocked beat) with significant symptoms due to hemodynamic 
instability associated with the heart block. 
 
5.  Sinus bradycardia associated with major symptoms (e.g., syncope, seizures, 
congestive heart failure (CHF)); or substantial sinus bradycardia (heart rate less than 50) 
associated with dizziness or confusion.  The correlation between symptoms and 
bradycardia must be documented, or the symptoms must be clearly attributable to the 
bradycardia rather than to some other cause. 
  6.  In selected and few patients, sinus bradycardia of lesser severity (heart rate 50-59) 
with dizziness or confusion.  The correlation between symptoms and bradycardia must be 
documented, or the symptoms must be clearly attributable to the bradycardia rather than 
to some other cause. 
 
7.  Sinus bradycardia is the consequence of long-term necessary drug treatment for which 
there is no acceptable alternative when accompanied by significant symptoms (e.g., 
syncope, seizures, CHF, dizziness, or confusion).  The correlation between symptoms and 
bradycardia must be documented, or the symptoms must be clearly attributable to the 
bradycardia rather than to some other cause. 
 
8.  Sinus node dysfunction with or without tachyarrhythmias or AV conduction block 
(i.e., the bradycardia-tachycardia syndrome, sino-atrial block, sinus arrest) when 
accompanied by significant symptoms (e.g., syncope, seizures, CHF, dizziness, or 
confusion). 
 
9.  Sinus node dysfunction with or without symptoms when there are potentially life-
threatening ventricular arrhythmias or tachycardia secondary to the bradycardia (e.g., 
numerous premature ventricular contractions, couplets, runs of premature ventricular 
contractions, or ventricular tachycardia). 
 
10.  Bradycardia associated with supraventricular tachycardia (e.g., atrial fibrillation, 
atrial flutter, or paroxysmal atrial tachycardia) with high-degree AV block which is 
unresponsive to appropriate pharmacological management and when the bradycardia is 
associated with significant symptoms (e.g., syncope, seizures, CHF, dizziness, or 
confusion). 
 
11.  The occasional patient with hypersensitive carotid sinus syndrome with syncope due 
to bradycardia and unresponsive to prophylactic medical measures. 
 
12.  Bifascicular or trifascicular block accompanied by syncope which is attributed to 
transient complete heart block after other plausible causes of syncope have been 
reasonably excluded. 
 
13.  Prophylactic pacemaker use following recovery from acute myocardial infarction 
(MI) during which there was temporary complete (third-degree) and/or Mobitz Type II 
second-degree AV block in association with bundle branch block. 
 
14.  In patients with recurrent and refractory ventricular tachycardia, "overdrive pacing" 
(pacing above the basal rate) to prevent ventricular tachycardia. 
 
(Effective May 9, 1985) 
 
15.  Second-degree AV heart block of Type I with the QRS complexes prolonged. 
 
B.  Nationally Non-Covered Indications   
Conditions which, although used by some physicians as a basis for permanent cardiac 
pacing, are considered unsupported by adequate evidence of benefit and therefore should 
not generally be considered appropriate uses for single-chamber pacemakers in the 
absence of the above indications.  A/B MACs should review claims for pacemakers with 
these indications to determine the need for further claims development prior to denying 
the claim, since additional claims development may be required.  The object of such 
further development is to establish whether the particular claim actually meets the 
conditions in a) above.  In claims where this is not the case or where such an event 
appears unlikely, the A/B MAC may deny the claim: 
 
1.  Syncope of undetermined cause. 
 
2.  Sinus bradycardia without significant symptoms. 
 
3.  Sino-atrial block or sinus arrest without significant symptoms. 
 
4.  Prolonged P-R intervals with atrial fibrillation (without third-degree AV block) or 
with other causes of transient ventricular pause. 
 
5.  Bradycardia during sleep. 
 
6.   Right bundle branch block with left axis deviation (and other forms of fascicular or 
bundle branch block) without syncope or other symptoms of intermittent AV block). 
 
7.  Asymptomatic second-degree AV block of Type I unless the QRS complexes are 
prolonged or electrophysiological studies have demonstrated that the block is at or 
beyond the level of the His bundle (a component of the electrical conduction system of 
the heart). 
 
Effective October 1, 2001  
 
8.  Asymptomatic bradycardia in post-MI patients about to initiate long-term beta-blocker 
drug therapy. 
 
C.  Other 
 
All other indications for single-chamber cardiac pacing for which CMS has not 
specifically indicated coverage remain nationally non-covered, except for Category B 
Investigational Device Exemption (IDE) clinical trials, or as routine costs of single-
chamber cardiac pacing associated with clinical trials, in accordance with section 310.1 
of the NCD Manual. 
 
Group II:  Dual-Chamber Cardiac Pacemakers  (Effective May 9, 1985) 
 
A.  Nationally Covered Indications   
Conditions under dual-chamber cardiac pacing are considered acceptable or necessary in 
the general medical community unless conditions 1 and 2 under Group II. B., are present: 
 
1.  Patients in who single-chamber (ventricular pacing) at the time of pacemaker insertion 
elicits a definite drop in blood pressure, retrograde conduction, or discomfort. 
 
2.  Patients in whom the pacemaker syndrome (atrial ventricular asynchrony), with 
significant symptoms, has already been experienced with a pacemaker that is being 
replaced. 
 
3.  Patients in whom even a relatively small increase in cardiac efficiency will 
importantly improve the quality of life, e.g., patients with CHF despite adequate other 
medical measures. 
 
4.  Patients in whom the pacemaker syndrome can be anticipated, e.g., in young and 
active people, etc. 
 
Dual-chamber pacemakers may also be covered for the conditions as listed in Group I. 
A., if the medical necessity is sufficiently justified through adequate claims development.  
Expert physicians differ in their judgments about what constitutes appropriate criteria for 
dual-chamber pacemaker use.  The judgment that such a pacemaker is warranted in the 
patient meeting accepted criteria must be based upon the individual needs and 
characteristics of that patient, weighing the magnitude and likelihood of anticipated 
benefits against the magnitude and likelihood of disadvantages to the patient. 
 
B.  Nationally Non-Covered Indications 
 
Whenever the following conditions (which represent overriding contraindications) are 
present, dual-chamber pacemakers are not covered: 
 
1.  Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left 
atrium. 
 
2.  Frequent or persistent supraventricular tachycardias, except where the pacemaker is 
specifically for the control of the tachycardia. 
 
3.  A clinical condition in which pacing takes place only intermittently and briefly, and 
which is not associated with a reasonable likelihood that pacing needs will become 
prolonged, e.g., the occasional patient with hypersensitive carotid sinus syndrome with 
syncope due to bradycardia and unresponsive to prophylactic medical measures. 
 
4.  Prophylactic pacemaker use following recovery from acute MI during which there was 
temporary complete (third-degree) and/or Type II second-degree AV block in association 
with bundle branch block. 
  C.  Other 
 
All other indications for dual-chamber cardiac pacing for which CMS has not specifically 
indicated coverage remain nationally non-covered, except for Category B IDE clinical 
trials, or as routine costs of dual-chamber cardiac pacing associated with clinical trials, in 
accordance with section 310.1 of the NCD Manual. 
 
20.8.1 - Cardiac Pacemaker Evaluation Services 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
Medicare covers a variety of services for the post-implant follow-up and evaluation of 
implanted cardiac pacemakers.  The following guidelines are designed to assist A/B 
MACs in identifying and processing claims for such services. 
 
NOTE:  These new guidelines are limited to lithium battery-powered pacemakers, 
because mercury-zinc battery-powered pacemakers are no longer being manufactured and 
virtually all have been replaced by lithium units.  A/B MACs still receiving claims for 
monitoring such units should continue to apply the guidelines published in 1980 to those 
units until they are replaced. 
 
There are two general types of pacemakers in current use - single-chamber pacemakers 
which sense and pace the ventricles of the heart, and dual-chamber pacemakers which 
sense and pace both the atria and the ventricles.  These differences require different 
monitoring patterns over the expected life of the units involved.  One fact of which A/B 
MACs should be aware is that many dual-chamber units may be programmed to pace 
only the ventricles; this may be done either at the time the pacemaker is implanted or at 
some time afterward.  In such cases, a dual-chamber unit, when programmed or 
reprogrammed for ventricular pacing, should be treated as a single-chamber pacemaker in 
applying screening guidelines. 
 
The decision as to how often any patients pacemaker should be monitored is the 
responsibility of the patients physician who is best able to take into account the 
condition and circumstances of the individual patient.  These may vary over time, 
requiring modifications of the frequency with which the patient should be monitored.  In 
cases where monitoring is done by some entity other than the patients physician, such as 
a commercial monitoring service or hospital outpatient department, the physicians 
prescription for monitoring is required and should be periodically renewed (at least 
annually) to assure that the frequency of monitoring is proper for the patient.  Where a 
patient is monitored both during clinic visits and transtelephonically, the A/B MAC 
should be sure to include frequency data on both types of monitoring in evaluating the 
reasonableness of the frequency of monitoring services received by the patient. 
Since there are over 200 pacemaker models in service at any given point, and a variety of 
patient conditions that give rise to the need for pacemakers, the question of the 
appropriate frequency of monitoring is a complex one.  Nevertheless, it is possible to 
develop guidelines within which the vast majority of pacemaker monitoring will fall and  A/B MACs should do this, using their own data and experience, as well as the frequency 
guidelines which follow, in order to limit extensive claims development to those cases 
requiring special attention. 
 
20.8.1.1 - Transtelephonic Monitoring of Cardiac Pacemakers 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
A.  General 
 
Transtelephonic monitoring of pacemakers is furnished by commercial suppliers, hospital 
outpatient departments, and physicians offices. 
 
Telephone monitoring of cardiac pacemakers as described below is medically efficacious 
in identifying early signs of possible pacemaker failure, thus reducing the number of 
sudden pacemaker failures requiring emergency replacement.  All systems that monitor 
the pacemaker rate (bpm) in both the free-running and/or magnetic mode are effective in 
detecting subclinical pacemaker failure due to battery depletion.  More sophisticated 
systems are also capable of detecting internal electronic problems within the pulse 
generator itself and other potential problems.  In the case of dual-chamber pacemakers in 
particular, such monitoring may detect failure of synchronization of the atria and 
ventricles, and the need for adjustment and reprogramming of the device. 
 
NOTE:  The transmitting device furnished to the patient is simply one component of the 
diagnostic system, and is not covered as durable medical equipment.  Those engaged in 
transtelephonic pacemaker monitoring should reflect the costs of the transmitters in 
setting their charges for monitoring. 
 
B.  Definition of Transtelephonic Monitoring 
 
In order for transtelephonic monitoring services to be covered, the services must consist 
of the following elements: 
 
  A minimum 30-second readable strip of the pacemaker in the free-running mode; 
 
  Unless contraindicated, a minimum 30-second readable strip of the pacemaker in the 
magnetic mode; and, 
 
  A minimum 30 seconds of readable ECG strip. 
 
C.  Frequency Guidelines for Transtelephonic Monitoring 
 
The guidelines below constitute a system which A/B MACs should use, in conjunction 
with their knowledge of local medical practices, to screen claims for transtelephonic 
monitoring prior to payment. It is important to note that they are not recommendations 
with respect to a minimum frequency for such monitorings, but rather a maximum  frequency (within which payment may be made without further claims development).  As 
with previous guidelines, more frequent monitorings may be covered in cases where A/B 
MACs are satisfied that such monitorings are medically necessary; e.g., based on the 
condition of the patient, or with respect to pacemakers exhibiting unexpected defects or 
premature failure.  A/B MACs should seek written justification for more frequent 
monitorings from the patients physician and/or any monitoring service involved. 
 
These guidelines are divided into two broad categories - Guideline I which will apply to 
the majority of pacemakers now in use, and Guideline II which will apply only to 
pacemaker systems (pacemaker and leads) for which sufficient long-term clinical 
information exists to assure that they meet the standards of the Inter-Society Commission 
for Heart Disease Resources (ICHD) for longevity and end-of-life decay.  (The ICHD 
standards are: (1) 90% cumulative survival at 5 years following implant; and (2) an end-
of-life decay of less than a 50% drop of output voltage and less than 20% deviation of 
magnet rate, or a drop of 5 beats per minute or less, over a period of 3 months or more.)  
A/B MACs should consult with their medical advisers and other appropriate individuals 
and organizations (such as the North American Society of Pacing and Electrophysiology 
which publishes product reliability information) should questions arise over whether a 
pacemaker system meets the ICHD standards. 
 
The two groups of guidelines are then further broken down into two general categories  
single-chamber and dual-chamber pacemakers. A/B MACs should be aware that the 
frequency with which a patient is monitored may be changed from time-to-time for a 
number of reasons, such as a change in the patients overall condition, a reprogramming 
of the patients pacemaker, the development of better information on the pacemakers 
longevity or failure mode, etc.  Consequently, changes in the proper set of guidelines may 
be required. A/B MACs should inform physicians and monitoring services to alert A/B 
MACs to any changes in the patients monitoring prescription that might necessitate 
changes in the screening guidelines applied to that patient.  (Of particular importance is 
the reprogramming of a dual-chamber pacemaker to a single-chamber mode of operation. 
Such reprogramming would shift the patient from the appropriate dual-chamber guideline 
to the appropriate single-chamber guideline.) 
 
Guideline I 
 
1 - Single-chamber pacemakers 
1st month - every 2 weeks. 
2nd through 36th month - every 8 weeks. 
37th month to failure - every 4 weeks. 
 
2 - Dual-chamber pacemaker 
1st month - every 2 weeks. 
2nd through 6th month - every 4 weeks. 
7th through 36th month - every 8 weeks. 
37th month to failure - every 4 weeks. 
  Guideline II 
 
1 - Single-chamber pacemakers 
1st month - every 2 weeks. 
2nd through 48th month - every 12 weeks. 
49th through 72nd month - every 8 weeks. 
Thereafter - every 4 weeks. 
 
2 - Dual-chamber pacemaker 
1st month - every 2 weeks. 
2nd through 30th month - every 12 weeks. 
31st through 48th month - every 8 weeks. 
Thereafter - every 4 weeks. 
 
D.  Pacemaker Clinic Services 
 
1.  General 
 
Pacemaker monitoring is also covered when done by pacemaker clinics.  Clinic visits 
may be done in conjunction with transtelephonic monitoring or as a separate service; 
however, the services rendered by a pacemaker clinic are more extensive than those 
currently possible by telephone.  They include, for example, physical examination of 
patients and reprogramming of pacemakers.  Thus, the use of one of these types of 
monitoring does not preclude concurrent use of the other. 
 
2.  Frequency Guidelines 
 
As with transtelephonic pacemaker monitoring, the frequency of clinic visits is the 
decision of the patients physician, taking into account, among other things, the medical 
condition of the patient.  However, A/B MACs can develop monitoring guidelines that 
will prove useful in screening claims.  The following are recommendations for 
monitoring guidelines on lithium-battery pacemakers: 
 
  For single-chamber pacemakers - twice in the first 6 months following implant, 
then once every 12 months. 
 
  For dual-chamber pacemakers - twice in the first 6 months, then once every 6 
months. 
 
20.8.2 - Self-Contained Pacemaker Monitors 
(Rev. 1, 10-03-03) 
 
CIM 60-7 
 
Self-contained pacemaker monitors are accepted devices for monitoring cardiac pace-
makers.  Accordingly, program payment may be made for the rental or purchase of either  of the following pacemaker monitors when a physician for a patient prescribes it with a 
cardiac pacemaker: 
 
A.  Digital Electronic Pacemaker Monitor 
 
This device provides the patient with an instantaneous digital readout of his pacemaker 
pulse rate.  Use of this device does not involve professional services until there has been 
a change of five pulses (or more) per minute above or below the initial rate of the 
pacemaker; when such change occurs, the patient contacts his physician. 
 
B.  Audible/Visible Signal Pacemaker Monitor 
 
This device produces an audible and visible signal which indicates the pacemaker rate.  
Use of this device does not involve professional services until a change occurs in these 
signals; at such time, the patient contacts his physician. 
 
NOTE:  The design of the self-contained pacemaker monitor makes it possible for the 
patient to monitor his pacemaker periodically and minimizes the need for regular visits to 
the outpatient department of the provider. 
 
Therefore, documentation of the medical necessity for pacemaker evaluation in the 
outpatient department of the provider should be obtained where such evaluation is 
employed in addition to the self-contained pacemaker monitor used by the patient in his 
home. 
 
Cross-reference:  20.8.1 
 
20.8.3  Single Chamber and Dual Chamber Permanent Cardiac 
Pacemakers 
(Rev. 187, Issued: 12-10-15, Effective: 08-13-13, Issued: 01-13-16) 
 
A.  General 
 
Permanent cardiac pacemakers refer to a group of self-contained, battery operated, 
implanted devices that send electrical stimulation to the heart through one or more 
implanted leads.  They are often classified by the number of chambers of the heart that 
the devices stimulate (pulse or depolarize).  Single chamber pacemakers typically target 
either the right atrium or right ventricle.  Dual chamber pacemakers stimulate both the 
right atrium and the right ventricle. 
 
The implantation procedure is typically performed under local anesthesia and requires 
only a brief hospitalization.  A catheter is inserted into the chest and the pacemakers 
leads are threaded through the catheter to the appropriate chamber(s) of the heart.  The 
surgeon then makes a small pocket in the pad of the flesh under the skin on the upper 
portion of the chest wall to hold the power source.  The pocket is then closed with 
stitches.   
The Centers for Medicare & Medicaid Services (CMS) has determined that the evidence 
is sufficient to conclude that implanted permanent cardiac pacemakers, single chamber or 
dual chamber, are reasonable and necessary for the treatment of non-reversible 
symptomatic bradycardia due to sinus node dysfunction and second and/or third degree 
atrioventricular block.  Symptoms of bradycardia are symptoms that can be directly 
attributable to a heart rate less than 60 beats per minute (for example:  syncope, seizures, 
congestive heart failure, dizziness, or confusion). 
 
B.  Nationally Covered Indications 
 
The following indications are covered for implanted permanent single chamber or dual 
chamber cardiac pacemakers:  
 
1.  Documented non-reversible symptomatic bradycardia due to sinus node dysfunction, 
and  
2.  Documented non-reversible symptomatic bradycardia due to second degree and/or 
third degree atrioventricular block. 
 
C.  Nationally Non-Covered Indications 
 
The following indications are non-covered for implanted permanent single chamber or 
dual chamber cardiac pacemakers:  
 
1.  Reversible causes of bradycardia such as electrolyte abnormalities, medications or 
drugs, and hypothermia, 
2.  Asymptomatic first degree atrioventricular block,  
3.  Asymptomatic sinus bradycardia,  
4.  Asymptomatic sino-atrial block or asymptomatic sinus arrest, 
5.  Ineffective atrial contractions (e.g., chronic atrial fibrillation or flutter, or giant left 
atrium) without symptomatic bradycardia,  
6.  Asymptomatic second degree atrioventricular block of Mobitz Type I unless the 
QRS complexes are prolonged or electrophysiological studies have demonstrated 
that the block is at or beyond the level of the His Bundle (a component of the 
electrical conduction system of the heart),  
7.  Syncope of undetermined cause,  
8.  Bradycardia during sleep, 
9.  Right bundle branch block with left axis deviation (and other forms of fascicular or 
bundle branch block) without syncope or other symptoms of intermittent 
atrioventricular block, 
10.  Asymptomatic bradycardia in post-myocardial infarction patients about to initiate 
long-term beta-blocker drug therapy, 
11.  Frequent or persistent supraventricular tachycardias, except where the pacemaker is 
specifically for the control of tachycardia, and 
12.  A clinical condition in which pacing takes place only intermittently and briefly, and 
which is not associated with a reasonable likelihood that pacing needs will become  prolonged. 
 
D.  Other 
 
A/B MACs will determine coverage under section 1862(a)(1)(A) of the Social Security 
Act for any other indications for the implantation and use of single chamber or dual 
chamber cardiac pacemakers that are not specifically addressed in this national coverage 
determination. 
 
(This NCD last reviewed August 2013.) 
 
20.8.4  Leadless Pacemakers  
(Rev. 201, Issued: 07-28-17, Effective: 01-18-18, Implementation: 08-29-17- for 
MAC local edits; January 2, 2018 - for MCS shared edits) 
 
A. General 
 
The leadless pacemaker eliminates the need for a device pocket and insertion of a pacing 
lead which are integral elements of traditional pacing systems. The removal of these 
elements eliminate an important source of complications associated with traditional 
pacing systems while providing similar benefits. Leadless pacemakers are delivered via 
catheter to the heart, and function similarly to other transvenous single-chamber 
ventricular pacemakers. 
 
B. Nationally Covered Indications 
 
Effective January 18, 2017, the Centers for Medicare & Medicaid Services (CMS) covers 
leadless pacemakers through Coverage with Evidence Development (CED).  CMS covers 
leadless pacemakers when procedures are performed in Food and Drug Administration 
(FDA) approved studies.  CMS also covers, in prospective longitudinal studies, leadless 
pacemakers that are used in accordance with the FDA approved label for devices that 
have either: 
  an associated ongoing FDA approved post-approval study; or 
  completed an FDA post-approval study. 
 
Each study must be approved by CMS and as a fully-described, written part of its 
protocol, must address the following research questions: 
  What are the peri-procedural and post-procedural complications of leadless 
pacemakers? 
  What are the long term outcomes of leadless pacemakers? 
  What are the effects of patient characteristics (age, gender, comorbidities) on the 
use and health effects of leadless pacemakers? 
 
CMS will review studies to determine if they meet the 13 criteria listed below.  If CMS 
determines that they meet these criteria, the study will be posted on CMS CED website  (https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-
Development/index.html).   
 
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.  
f.  The research study is in compliance with all applicable Federal regulations 
concerning the protection of human subjects found in the Code of Federal 
Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food and 
Drug Administration (FDA), it is also in compliance with 21 CFR Parts 50 and 
56.  In addition, to further enhance the protection of human subjects in studies 
conducted under CED, the study must provide and obtain meaningful informed 
consent from patients regarding the risks associated with the study items and/or 
services, and the use and eventual disposition of the collected data.  
g.  All aspects of the study are conducted according to appropriate standards of 
scientific integrity.  
h.  The study has a written protocol that clearly demonstrates adherence to the 
standards listed here as Medicare requirements.  
i.  The study is not designed to exclusively test toxicity or disease pathophysiology 
in healthy individuals. Such studies may meet this requirement only if the disease 
or condition being studied is life threatening as defined in 21 CFR 312.81(a) and 
the patient has no other viable treatment options.  
j.  The clinical research studies and registries are registered on the 
www.ClinicalTrials.gov website by the principal sponsor/investigator prior to the 
enrollment of the first study subject.  Registries are also registered in the Agency 
for Healthcare Research and Quality (AHRQ) Registry of Patient Registries 
(RoPR).  
k.  The research study protocol specifies the method and timing of public release of 
all prespecified outcomes to be measured including release of outcomes if 
outcomes are negative or study is terminated early.  The results must be made 
public within 12 months of the studys primary completion date, which is the date 
the final subject had final data collection for the primary endpoint, even if the trial 
does not achieve its primary aim.  The results must include number 
started/completed, summary results for primary and secondary outcome measures, 
statistical analyses, and adverse events. Final results must be reported in a 
publicly accessibly manner; either in a peer-reviewed scientific journal (in print or 
on-line), in an on-line publicly accessible registry dedicated to the dissemination  of clinical trial information such as ClinicalTrials.gov, or in journals willing to 
publish in abbreviated format (e.g., for studies with negative or incomplete 
results).  
l.  The study protocol must explicitly discuss beneficiary subpopulations affected by 
the item or service under investigation, particularly traditionally underrepresented 
groups in clinical studies, how the inclusion and exclusion criteria effect 
enrollment of these populations, and a plan for the retention and reporting of said 
populations in the trial.  If the inclusion and exclusion criteria are expected to 
have a negative effect on the recruitment or retention of underrepresented 
populations, the protocol must discuss why these criteria are necessary.  
m. The study protocol explicitly discusses how the results are or are not expected to 
be generalizable to affected beneficiary subpopulations. Separate discussions in 
the protocol may be necessary for populations eligible for Medicare due to age, 
disability or Medicaid eligibility.  
 
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality 
(AHRQ) supports clinical research studies that CMS determines meet the above-listed 
standards and address the above-listed research questions.  
 
All clinical research study protocols must be reviewed and approved by CMS.  The 
principal investigator must submit the complete study protocol, identify the relevant CMS 
research question(s) that will be addressed and cite the location of the detailed analysis 
plan for those questions in the protocol, plus provide a statement addressing how the 
study satisfies each of the standards of scientific integrity (a. through m. listed above), as 
well as the investigators contact information, to the address below. The information will 
be reviewed, and approved studies will be identified on the CMS website.  
 
Director, Coverage and Analysis Group 
Re: Leadless Pacemakers CED 
Centers for Medicare & Medicaid Services (CMS) 
7500 Security Blvd., Mail Stop S3-02-01 
Baltimore, MD 21244-1850 
 
Email address for protocol submissions: clinicalstudynotification@cms.hhs.gov 
Email subject line: CED [NCD topic (i.e. Leadless Pacemakers)] [name of 
sponsor/primary investigator] 
 
C. Nationally Non-Covered Indications 
 
Leadless pacemakers are non-covered when furnished outside of a CMS approved CED 
study. 
 
D. Other 
 
NA 
  (This NCD last reviewed January 2017.) 
 
20.9 - Artificial Hearts and Related Devices (RETIRED) 
(Rev. 11892; Issued: 03-09-23; Effective: 04-10-23; Implementation:04-10-23)   
 
This section has been removed from the NCD Manual and incorporated into NCD 20.9.1 
effective December 1, 2020. 
 
20.9.1 - Ventricular Assist Devices (VADs) 
(Rev.10837; Issued: 06-11-21; Effective: 12-01-20; Implementation: 07-27-21) 
 
A. General  
 
A ventricular assist device (VAD) is surgically attached to one or both intact ventricles 
and is used to assist or augment the ability of a damaged or weakened native heart to 
pump blood. Improvement in the performance of the native heart may allow the device to 
be removed. 
 
Indications and Limitations of Coverage 
 
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-transplant) 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:  
  Are on optimal medical management (OMM), based on current heart 
o
failure practice guidelines for at least 45 out of the last 60 days and are 
failing to respond; or    Have advanced heart failure for at least 14 days and are dependent on an 
o
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, training, 
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 participate 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 cardiothoracic 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 heart 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 credentialing 
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 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 Medicare Administrative Contractors 
within their respective jurisdictions. 
 
 
 
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 VADs 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 following 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 medical 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: 
    At least one physician with cardiothoracic surgery privileges and individual 
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 medical 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 for 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 
  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 transluminal 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 35% 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 
 
Any cardiac indication not specifically identified in 42 CFR  410.49(b)(1)(vii) or 
identified 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 
 
Intraoperative 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 with 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 mapping 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 activation 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 covered 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 defects, and after cardiac arrest. 
 
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. 
Medicare 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 cardiogram 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 plethysmography 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 is 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. 
 
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 Plethysmography 
 
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. 
 
Photoelectric Plethysmography - This method is considered 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 blood 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 done 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. 
 
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 interpretation 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 activities, 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 
arrhythmic 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-threatening 
arrhythmias) as compared to devices or services in the currently described categories 
below. 
 
Descriptions of Ambulatory EKG Monitoring Technologies 
 
1.  Dynamic electrocardiography devices that continuously record a real-time EKG, 
commonly known as HolterTM 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 recording 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, automatically 
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 data 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. 
 
Cardiac event monitors without transtelephonic capability must be removed from the 
patient and taken to a location for review of the stored EKG data.  Some devices also 
permit a "time sampling" mode of operation.  The "time sampling" mode is not covered 
under ambulatory EKG monitoring technology.  Some cardiac event monitoring devices 
with trans-telephonic capabilities require the patient to dial the phone number of a central 
EKG data reception center and initiate transmission of EKG data. Other devices use 
Internet-based in-home computers to capture and store EKG data.  When such devices 
detect pre-programmed arrhythmias, data is automatically sent via modem and standard 
telephone lines to a central receiving center, or independent diagnostic testing facility 
(IDTF), where the data is reviewed.  Internet-based in-home computer systems may also  provide the receiving center with a daily computer-generated report that summarizes 24 
hours of EKG data. 
 
Certain cardiac event monitors capture electrical activity with a single electrode attached 
to the skin.  Other devices may employ multiple electrodes in order to record more 
complex EKG tracings.  Additionally, devices may be individually programmed to detect 
patient-specific factors, electrode malfunction, or other factors.  Cardiac event monitors 
can be further categorized as either pre-event or post-event recorders, based on their 
memory capabilities: 
 
a.  Pre-symptom Memory Loop Recorder (MLR) 
 
Upon detecting symptoms, the wearer presses a button, which activates the recorder to 
save (i.e., memorize) an interval of pre-symptom EKG data along with data during and 
subsequent to the symptomatic event.  Self-sensing recorders (also known as event-
activated or automatic trigger) do not require patient input to capture these data.  Single 
or multiple events may be recorded.  The device is worn at all times, usually for up to 30 
days. 
 
  Implantable (or Insertable Loop) Recorder (ILR) 
o
 
Another type of pre-symptom MLR, it is implanted subcutaneously in a patients upper 
left chest and may remain implanted for many months.  An ILR is used when syncope is 
thought to be cardiac-related, but is too infrequent to be detected by either a HolterTM 
monitor or a traditional pre-symptom MLR. 
 
b.  Post-symptom Recorder 
 
The patient temporarily places this device against the chest when symptoms occur and 
activates it by pressing a button.  These recorders represent old technology, as they do not 
include a memory loop.  The device transmits EKG data telephonically in real-time and is 
usually used for up to 30 days. 
 
B.  Nationally Covered Indications 
 
The following indications are covered nationally unless otherwise indicated: 
 
1.  Computer analysis of EKGs when furnished in a setting and under the 
circumstances required for coverage of other EKG services. 
 
2.  EKG services rendered by an IDTF, including physician review and interpretation.  
Separate physician services are not covered unless he/she is the patients attending or 
consulting physician. 
 
3.  Emergency EKGs (i.e., when the patient is or may be experiencing a life-
threatening event) performed as a laboratory or diagnostic service by a portable x-ray  supplier only when a physician is in attendance at the time the service is performed or 
immediately thereafter. 
 
4  Home EKG services with documentation of medical necessity. 
 
5.  Transtelephonic EKG transmissions (effective March 1, 1980) as a diagnostic 
service for the indications described below, when performed with equipment meeting the 
standards described below, subject to the limitations and conditions specified below.  
Coverage is further limited to the amounts payable with respect to the physicians service 
in interpreting the results of such transmissions, including charges for rental of the 
equipment. The device used by the beneficiary is part of a total diagnostic system and is 
not considered DME separately.  Covered uses are to: 
 
a.  Detect, characterize, and document symptomatic transient arrhythmias; 
 
b.  Initiate, revise, or discontinue arrhythmic drug therapy; or,  
 
c.  Carry-out early post-hospital monitoring of patients discharged after myocardial 
infarction (MI); (only if 24-hour coverage is provided, see C.5. below). 
 
Certain uses other than those specified above may be covered if, in the judgment of the 
local A/B MAC, such use is medically necessary. 
 
Additionally, the transmitting devices must meet at least the following criteria: 
 
a.  They must be capable of transmitting EKG Leads, I, II, or III; and, 
 
b.  The tracing must be sufficiently comparable to a conventional EKG. 
 
24-hour attended coverage used as early post-hospital monitoring of patients discharged 
after MI is only covered if provision is made for such 24-hour attended coverage in the 
manner described below: 
 
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 Non-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 rendered 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 
eligible 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., HolterTM 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 pacemakers 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 transplant 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 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. 
 
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 otherwise 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 Tests 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 effective.  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 experienced 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.  ABPM 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 least 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 information 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 described 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 normotensives.  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, since 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 July 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 cardiothoracic 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 readily 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 placed 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 inflated 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 treatment, 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, controlled 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; Issued: 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 enlarged 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 considered 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 representation  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 disease. 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 adenocarcinoma 
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 intoxication, 
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 peripheral 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 higher; 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 with 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 insufficiency. 
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 storage. 
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 service 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 was 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 risk 
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 minute 
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 determine 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 for 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 following 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 Program (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 comprehensive 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 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.) 
 
20.31.3  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 risk 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 program 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: 06-10-20, 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 percutaneously 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 cohesive, 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 interventional 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 interventional 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: 
 
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 experience: 
 
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 metric. For 
the below CED questions (i-iv), the results must be reported publicly as described 
in CED criterion k. 
 
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 Research 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 performed 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 rate 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 incidence 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. 
 
f.  The research study is in compliance with all applicable Federal regulations 
concerning the protection of human subjects found in the Code of Federal 
Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food 
and Drug Administration (FDA), it is also in compliance with 21 CFR 
Parts 50 and 56. In addition, to further enhance the protection of human 
subjects in studies conducted under CED, the study must provide and 
obtain meaningful informed consent from patients regarding the risks 
associated with the study items and /or services, and the use and eventual 
disposition of the collected data. 
 
g.  All aspects of the research study are conducted according to appropriate 
standards of scientific integrity. 
 
h.  The study has a written protocol that clearly demonstrates adherence to the 
standards listed here as Medicare requirements. 
 
i.  The study is not designed to exclusively test toxicity or disease 
pathophysiology in healthy individuals. Such studies may meet this 
requirement only if the disease or condition being studied is life  threatening as defined in 21 CFR 312.81(a) and the patient has no other 
viable treatment options. 
 
j.  The clinical research studies and registries are registered on the 
www.ClinicalTrials.gov website by the principal sponsor/investigator 
prior to the enrollment of the first study subject. Registries are also 
registered in the Agency for Healthcare Quality (AHRQ) Registry of 
Patient Registries (RoPR). 
 
k.  The research study protocol specifies the method and timing of public 
release of all prespecified outcomes to be measured including release of 
outcomes if outcomes are negative or study is terminated early. The results 
must be made public within 12 months of the studys primary completion 
date, which is the date the final subject had final data collection for the 
primary endpoint, even if the trial does not achieve its primary aim. The 
results must include number started/completed, summary results for 
primary and secondary outcome measures, statistical analyses, and adverse 
events. Final results must be reported in a publicly accessibly manner; 
either in a peer-reviewed scientific journal (in print or on-line), in an on-
line publicly accessible registry dedicated to the dissemination of clinical 
trial information such as ClinicalTrials.gov, or in journals willing to 
publish in abbreviated format (e.g., for studies with negative or incomplete 
results). 
 
l.  The study protocol must explicitly discuss beneficiary subpopulations 
affected by the item or service under investigation, particularly 
traditionally underrepresented groups in clinical studies, how the inclusion 
and exclusion criteria effect enrollment of these populations, and a plan 
for the retention and reporting of said populations on the trial. If the 
inclusion and exclusion criteria are expected to have a negative effect on 
the recruitment or retention of underrepresented populations, the protocol 
must discuss why these criteria are necessary. 
m. The study protocol explicitly discusses how the results are or are not 
expected to be generalizable to affected beneficiary subpopulations. 
Separate discussions in the protocol may be necessary for populations 
eligible for Medicare due to age, disability or Medicaid eligibility. 
 
Consistent with section 1142 of the Act, the Agency for Healthcare Research and Quality 
(AHRQ) supports clinical research studies that meet the above-listed standards and 
address the above-listed research questions. 
 
The principal investigator must submit the complete study protocol, identify the relevant 
CMS research question(s) that will be addressed, and cite the location of the detailed 
analysis plan for those questions in the protocol, plus provide a statement addressing how 
the study satisfies each of the standards of scientific integrity (a. through m. listed above),  as well as the investigator's contact information, to the address below. The information 
will be reviewed, and approved studies will be identified on the CMS Website. 
 
Director, Coverage and Analysis Group 
Re: TAVR CED 
Centers for Medicare & Medicaid Services (CMS) 
7500 Security Blvd., Mail Stop S3-02-01 
Baltimore, MD 21244-1850 
 
Email address for protocol submissions: clinicalstudynotification@cms.hhs.gov 
Email subject line: CED [NCD topic (i.e. TAVR)] [name of sponsor/primary 
investigator] 
 
C. Nationally Non-Covered Indications 
 
TAVR is not covered for patients in whom existing co-morbidities would preclude the 
expected benefit from correction of the aortic stenosis. 
 
D. Other 
 
NA 
 
(This NCD last reviewed June 2019) 
 
 
20.33 - Transcatheter Edge-to-Edge Repair (TEER) for Mitral Valve 
Regurgitation 
(Rev. 12112; Issued: 06-29-23; Effective: 07- 31-23; Implementation: 07-31- 23) 
 
A.  General 
 
Transcatheter Edge-to-Edge Repair (TEER) of the mitral valve is used in the treatment of 
mitral regurgitation.  TEER approximates the anterior and posterior mitral valve leaflets 
by grasping them with a clipping device in an approach similar to a treatment developed 
in cardiac surgery called the Alfieri stitch. 
 
B. Nationally Covered Indications 
 
The Centers for Medicare & Medicaid Services (CMS) covers TEER of the mitral valve 
under Coverage with Evidence Development (CED) with the following conditions: 
 
A.  For the treatment of symptomatic moderate-to-severe or severe functional mitral 
regurgitation (MR) when the patient remains symptomatic despite stable doses of 
maximally tolerated guideline-directed medical therapy (GDMT) plus cardiac 
resynchronization therapy, if appropriate, or for the treatment of significant 
symptomatic degenerative MR 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 mitral valve TEER system that has received 
FDA premarket approval (PMA). 
 
2.  The patient (preoperatively and postoperatively) is under the care of a heart team: 
a cohesive, multidisciplinary, team of medical professionals.  The heart team 
concept embodies collaboration and dedication across medical specialties to offer 
optimal patient-centered care. The heart team must include the following 
members with experience and training as specified: 
 
a.  Cardiac surgeon 
i.  With  20 mitral valve surgeries per year or  40 over two years, 
50% of which are mitral valve repairs; and, 
ii.  Who is board eligible or certified in cardiothoracic surgery or 
similar foreign equivalent. 
b.  Interventional cardiologist 
i.  With professional experience of  50 career structural heart disease 
procedures; or  30 left-sided structural procedures per year; and, 
ii.  With participation in  20 career trans-septal interventions 
including 10 as primary or co-primary operator; and, 
iii.  Who is board eligible or certified in interventional cardiology or 
similar foreign equivalent. 
c.  Interventional echocardiographer (cardiologist or anesthesiologist) 
i.  With professional experience of  10 trans-septal guidance 
procedures and  30 structural heart procedures; and, 
ii.  Who is board eligible or certified in transesophageal 
echocardiography with advanced training as required for 
privileging by the hospital where the TEER is performed. 
d.  Heart failure cardiologist experienced in treating patients with advanced 
heart failure (only required for functional MR patients); and, 
e.  Providers from other physician groups as well as advanced patient 
practitioners, nurses, research personnel, and administrators. 
 
3.  Each patients suitability for surgical mitral valve repair, TEER, or palliative 
therapy must be evaluated, documented, and made available to other heart team 
members.  Additionally, for patients with functional MR, the heart team heart 
failure cardiologist must document that the patient has persistent symptoms 
despite maximally tolerated GDMT and cardiac resynchronization therapy, if 
appropriate, as described below: 
 
a.  For patients with functional MR: the heart team interventional cardiologist 
and heart team heart failure cardiologist independently evaluate the patient 
using information in the medical record and a face-to-face examination.  
To decrease patient burden, the heart team heart failure cardiologist may  meet this requirement through a review of the patients records and images 
if the patient has an established relationship with a cardiologist 
experienced in treating patients with advanced heart failure. 
 
b.  For patients with degenerative MR: the heart team interventional 
cardiologist and heart team cardiac surgeon must independently evaluate 
the patient using information in the medical record and a face-to-face 
examination. 
 
4.  An interventional cardiologist or cardiac surgeon from the heart team must 
perform the mitral valve TEER and an interventional echocardiographer from the 
heart team must perform transesophageal echocardiography during the procedure.  
The interventional echocardiographer may not also furnish anesthesiology during 
the same procedure. The interventional cardiologist and cardiac surgeon may 
jointly participate in the intra-operative technical aspects of TEER as appropriate. 
All physicians who participate in the procedure must have device-specific training 
as required by the manufacturer.  
 
5.  Mitral valve TEERs must be furnished in a hospital with appropriate 
infrastructure and experience 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 procedures; 
c.  Hospital volume requirements below must be met and maintained: 
i.   20 mitral valve surgical procedures for severe MR per year or  
40 over two years, of which at least 10 (or 20 over two years) must 
be mitral valve repairs; and, 
ii.   2 physicians with cardiac surgery privileges experienced in 
valvular surgery; and, 
iii.   1 physician with interventional cardiology privileges; and, 
iv.   300 percutaneous coronary interventions (PCIs) per year. 
 
6.  The heart team and hospital are participating in a prospective, national, audited 
registry that: 1) comprehensively enrolls TEER 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 Code of Federal Regulations (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: 
 
a.  Stroke; 
b.  All-cause mortality;  c.  Repeat TEER or other mitral procedures; 
d.  Transient Ischemic Attacks (TIAs); 
e.  Major vascular events; 
f.  Renal complications; 
g.  Functional capacity; and 
h.  Quality of Life (QoL). 
 
7.  The registry shall collect all data necessary and have a written executable analysis 
plan in place to address the following questions. Specifically, for the CED 
question d, this must be addressed through a composite metric. For the below 
CED questions (a-e), the results must be reported publicly as described in CED 
criterion k. 
 
a.  When TEER procedures are performed outside a controlled clinical study, 
how do outcomes and adverse events compare to the pivotal clinical 
studies? 
b.  How do outcomes and adverse events in subpopulations compare to 
patients in the pivotal clinical studies? 
c.  What is the long-term ( 5 year) durability of the device? 
d.  What are the long-term ( 5 year) outcomes and adverse events? 
e.  How do the demographics of registry patients compare to the pivotal 
studies? 
 
Consistent with section 1142 of the Act, the Agency for Healthcare Research and 
Quality (AHRQ) supports clinical research studies that CMS determines meet the 
above-listed standards and address the above-listed research questions. 
 
B.  Mitral valve TEERs are covered for uses that are not expressly listed as an FDA-
approved indication when performed within a clinical study that fulfills all of the 
following: 
 
1.  An interventional cardiologist or cardiac surgeon must perform the mitral valve 
TEER and an interventional echocardiographer must perform transesophageal 
echocardiography during the procedure. The interventional echocardiographer 
may not also furnish anesthesiology during the same procedure.  The 
interventional cardiologist and cardiac surgeon may jointly participate in the intra-
operative technical aspects of TEER as appropriate. All physicians who 
participate in the procedure must have device specific training as required by the 
manufacturer. 
 
2.  As a fully-described, written part of its protocol, the clinical research trial must 
critically evaluate the following questions at 12 months or longer follow-up: 
 
a.  What is the rate of all-cause mortality in the intervention group? 
b.  What is the rate of re-operations (open surgical or transcatheter) of the 
mitral valve in the intervention group?  c.  What is the rate of moderate-to-severe or severe MR in the intervention 
groups? 
 
3.  As a fully-described, written part of its protocol, the clinical research study must 
critically evaluate not only each patients quality of life pre- and post-TEER 
(minimum 1 year), but must also address at least one of the following questions: 
 
a.  What is the incidence of stroke? 
b.  What is the incidence of TIAs? 
c.  What is the incidence of major vascular events? 
d.  What is the incidence of renal complications? 
e.  What is the incidence of worsening MR? 
f.  What is the change in quality of life after TEER? 
g.  What is the change in the patients functional capacity after TEER? 
 
4.  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 (NCD). 
e.  The study is sponsored by an organization or individual capable of 
completing it successfully. 
f.  The research study is in compliance with all applicable Federal regulations 
concerning the protection of human subjects found in the Code of Federal 
Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the Food 
and Drug Administration (FDA), it is also in compliance with 21 CFR 
Parts 50 and 56. In addition, to further enhance the protection of human 
subjects in studies conducted under CED, the study must provide and 
obtain meaningful informed consent from patients regarding the risks 
associated with the study items and /or services, and the use and eventual 
disposition of the collected data. 
g.  All aspects of the research study are conducted according to appropriate 
standards of scientific integrity. 
h.  The study has a written protocol that clearly demonstrates adherence to the 
standards listed here as Medicare requirements. 
i.  The study is not designed to exclusively test toxicity or disease 
pathophysiology in healthy individuals. Such studies may meet this 
requirement only if the disease or condition being studied is life  threatening as defined in 21 CFR 312.81(a) and the patient has no other 
viable treatment options. 
j.  The clinical research studies and registries are registered on the 
www.ClinicalTrials.gov website by the principal sponsor/investigator 
prior to the enrollment of the first study subject. Registries are also 
registered in the Agency for Healthcare Quality (AHRQ) Registry of 
Patient Registries (RoPR). 
k.  The research study protocol specifies the method and timing of public 
release of all prespecified outcomes to be measured including release of 
outcomes if outcomes are negative or study is terminated early. The results 
must be made public within 12 months of the studys primary completion 
date, which is the date the final subject had final data collection for the 
primary endpoint, even if the trial does not achieve its primary aim. The 
results must include number started/completed, summary results for 
primary and secondary outcome measures, statistical analyses, and adverse 
events. Final results must be reported in a publicly accessibly manner; 
either in a peer-reviewed scientific journal (in print or on-line), in an on-
line publicly accessible registry dedicated to the dissemination of clinical 
trial information such as ClinicalTrials.gov, or in journals willing to 
publish in abbreviated format (e.g., for studies with negative or incomplete 
results). 
l.  The study protocol must explicitly discuss beneficiary subpopulations 
affected by the item or service under investigation, particularly 
traditionally underrepresented groups in clinical studies, how the inclusion 
and exclusion criteria effect enrollment of these populations, and a plan 
for the retention and reporting of said populations on the trial. If the 
inclusion and exclusion criteria are expected to have a negative effect on 
the recruitment or retention of underrepresented populations, the protocol 
must discuss why these criteria are necessary. 
m.  The study protocol explicitly discusses how the results are or are not 
expected to be generalizable to affected beneficiary subpopulations. 
Separate discussions in the protocol may be necessary for populations 
eligible for Medicare due to age, disability or Medicaid eligibility. 
 
Consistent with section 1142 of the Act, the Agency for Healthcare Research and 
Quality (AHRQ) supports clinical research studies that meet the above-listed 
standards and address the above-listed research questions. 
 
The principal investigator must submit the complete study protocol, identify the 
relevant CMS research question(s) that will be addressed, and cite the location of 
the detailed analysis plan for those questions in the protocol, plus provide a 
statement addressing how the study satisfies each of the standards of scientific 
integrity (a. through m. listed above), as well as the investigator's contact 
information, to the address below. The information will be reviewed, and 
approved studies will be identified on the CMS Website. 
  Director, Coverage and Analysis Group 
Re: TEER CED 
Centers for Medicare & Medicaid Services (CMS) 
7500 Security Blvd., Mail Stop S3-02-01 
Baltimore, MD 21244-1850 
 
Email address for protocol submissions: clinicalstudynotification@cms.hhs.gov 
Email subject line: "CED TEER [name of sponsor/primary investigator]" 
 
C.  Nationally Non-Covered Indications 
 
TEER of the mitral valve is not covered under the following circumstances: 
 
1.  For patients in whom existing co-morbidities would preclude the expected benefit 
from a mitral valve TEER procedure. 
2.  In patients with untreated severe aortic stenosis. 
 
D.  Other 
 
CMS will consider published, peer-reviewed evidence periodically, following the 
effective date of this NCD and reconsider the policy when appropriate.  The NCD will 
expire 10 years from the effective date if it is not reconsidered during that time.  Upon 
expiration, coverage will be at the discretion of the Medicare Administrative Contractors.   
 
 
20.34 - Percutaneous Left Atrial Appendage Closure (LAAC) 
(Rev. 192, Issued: 05-06-16, Effective: 02-08-16, Implementation: 10-03-16) 
 
A.  General 
 
Patients with atrial fibrillation (AF), an irregular heartbeat, are at an increased risk of 
stroke.  The left atrial appendage (LAA) is a tubular structure that opens into the left 
atrium and has been shown to be one potential source for blood clots that can cause 
strokes.  While thinning the blood with anticoagulant medications has been proven to 
prevent strokes, percutaneous LAA closure (LAAC) has been studied as a non-
pharmacologic alternative for patients with AF. 
 
B.  Nationally Covered Indications 
 
The Centers for Medicare & Medicaid Services (CMS) covers percutaneous LAAC for 
non-valvular atrial fibrillation (NVAF) through Coverage with Evidence Development 
(CED) with the following conditions: 
 
a.  LAAC devices are covered when the device has received Food and Drug 
Administration (FDA) Premarket Approval (PMA) for that devices FDA-
approved indication and meet all of the conditions specified below:   
The patient must have: 
 
  A CHADS2 score   2 (Congestive heart failure, Hypertension, Age >75, 
o
Diabetes, Stroke/transient ischemia attack/thromboembolism) or CHA2DS2-
VASc score  3 (Congestive heart failure, Hypertension, Age  65, Diabetes, 
Stroke/transient ischemia attack/thromboembolism, Vascular disease, Sex 
category) 
 
  A formal shared decision making interaction with an independent non-
o
interventional physician using an evidence-based decision tool on oral 
anticoagulation in patients with NVAF prior to LAAC.  Additionally, the shared 
decision making interaction must be documented in the medical record.  
 
  A suitability for short-term warfarin but deemed unable to take long-term oral 
o
anticoagulation following the conclusion of shared decision making, as LAAC is 
only covered as a second line therapy to oral anticoagulants.  The patient 
(preoperatively and postoperatively) is under the care of a cohesive, 
multidisciplinary team (MDT) of medical professionals.  The procedure must be 
furnished in a hospital with an established structural heart disease (SHD) and/or 
electrophysiology (EP) program.  
 
The procedure must be performed by an interventional cardiologist(s), 
electrophysiologist(s), or cardiovascular surgeon (s) that meet the following criteria: 
 
  Has received training prescribed by the manufacturer on the safe and effective use 
of the device prior to performing LAAC; and, 
 
  Has performed  25 interventional cardiac procedures that involve transeptal 
puncture through an intact septum; and, 
 
  Continues to perform  25 interventional cardiac procedures that involve 
transeptal puncture through an intact septum, of which at least 12 are LAAC, over 
a 2-year period. 
 
The patient is enrolled in, and the MDT and hospital must participate in, a prospective, 
national, audited registry that: 1) consecutively enrolls LAAC patients, and, 2) tracks the 
following annual outcomes for each patient for a period of at least 4 years from the time 
of the LAAC: 
 
  Operator-specific complications 
  Device-specific complications including device thrombosis 
  Stroke, adjudicated, by type 
  Transient Ischemic Attack (TIA) 
  Systemic embolism 
  Death    Major bleeding, by site and severity 
 
The registry must be designed to permit identification and analysis of patient, 
practitioner, and facility level factors that predict patient risk for these outcomes.  The 
registry must collect all data necessary to conduct analyses adjusted for relevant 
confounders, and have a written executable analysis plan in place to address the 
following questions: 
 
  How do the outcomes listed above compare to outcomes in the pivotal clinical 
trials in the short term (12 months) and in the long term ( 4 years)? 
 
  What is the long term ( 4 year) durability of the device? 
 
  What are the short term (12 months) and the long term (4 years) device-
specific complications including device thromboses? 
 
To appropriately address some of these questions, Medicare claims or other outside data 
may be necessary. 
 
Registries must be reviewed and approved by CMS.  Potential registry sponsors must 
submit all registry documentation to CMS for approval, including the written executable 
analysis plan and auditing plan.  CMS will review the qualifications of candidate 
registries to ensure that the approved registry follows standard data collection practices, 
and collects data necessary to evaluate the patient outcomes specified above.  The 
registrys national clinical trial number must be recorded on the claim. 
 
Consistent with section 1142 of the Social Security Act (the Act), the Agency for 
Healthcare Research and Quality (AHRQ) supports clinical research studies that CMS 
determines address the above-listed research questions and the a-m criteria listed in 
Section c. of this decision. 
 
All approved registries will be posted on the CED website located at: 
https://www.cms.gov/Medicare/Coverage/Coverage-with-Evidence-
Development/index.html. 
 
b.  LAAC is covered for NVAF patients not included in Section a. of this decision 
when performed within an FDA-approved randomized controlled trial (RCT) if 
such trials meet the criteria established below: 
 
As a fully-described written part of its protocol, the RCT must critically answer, in 
comparison to optimal medical therapy, the following questions: 
 
  As a primary endpoint, what is the true incidence of ischemic stroke and systemic 
embolism? 
 
  As a secondary endpoint, what is cardiovascular mortality and all-cause  mortality? 
 
FDA-approved RCTs must be reviewed and approved by CMS. Consistent with section 
1142 of the Act, AHRQ supports clinical research studies that CMS determines address 
the above-listed research questions and the a-m criteria listed in Section c. of this 
decision. 
 
The principal investigator must submit the complete study protocol, identify the relevant 
CMS research question(s) that will be addressed, and cite the location of the detailed 
analysis plan for those questions in the protocol, plus provide a statement addressing how 
the study satisfies each of the standards of scientific integrity a. through m. listed in 
section c. of this decision, as well as the investigators contact information, to the address 
below. 
 
Director, Coverage and Analysis Group 
Re: LAAC CED 
Centers for Medicare & Medicaid Services  
7500 Security Blvd., Mail Stop S3-02-01 
Baltimore, MD 21244-1850 
 
c.  All clinical studies, RCTs and registries submitted for review 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. 
 
f.  The research study is in compliance with all applicable Federal regulations 
concerning the protection of human subjects found in the Code of Federal 
Regulations (CFR) at 45 CFR Part 46. If a study is regulated by the FDA, it is 
also in compliance with 21 CFR Parts 50 and 56. In addition, to further 
enhance the protection of human subjects in studies conducted under CED, the  study must provide and obtain meaningful informed consent from patients 
regarding the risks associated with the study items and/or services, and the use 
and eventual disposition of the collected data. 
 
g.  All aspects of the study are conducted according to appropriate standards of 
scientific integrity. 
 
h.  The study has a written protocol that clearly demonstrates adherence to the 
standards listed here as Medicare requirements. 
 
i.  The study is not designed to exclusively test toxicity or disease 
pathophysiology in healthy individuals. Such studies may meet this 
requirement only if the disease or condition being studied is life threatening as 
defined in 21 CFR 312.81(a) and the patient has no other viable treatment 
options. 
 
j.  The clinical research studies and registries are registered on the 
www.ClinicalTrials.gov website by the principal sponsor/investigator prior to 
the enrollment of the first study subject. Registries are also registered in the 
AHRQ Registry of Patient Registries (RoPR). 
 
k.  The research study protocol specifies the method and timing of public release 
of all prespecified outcomes to be measured including release of outcomes if 
outcomes are negative or study is terminated early. The results must be made 
public within 12 months of the studys primary completion date, which is the 
date the final subject had final data collection for the primary endpoint, even if 
the trial does not achieve its primary aim. The results must include number 
started/completed, summary results for primary and secondary outcome 
measures, statistical analyses, and adverse events. Final results must be 
reported in a publicly accessibly manner; either in a peer-reviewed scientific 
journal (in print or on-line), in an on-line publicly accessible registry 
dedicated to the dissemination of clinical trial information such as 
ClinicalTrials.gov, or in journals willing to publish in abbreviated format 
(e.g., for studies with negative or incomplete results). 
 
l.  The study protocol must explicitly discuss beneficiary subpopulations affected 
by the item or service under investigation, particularly traditionally 
underrepresented groups in clinical studies, how the inclusion and exclusion 
criteria effect enrollment of these populations, and a plan for the retention and 
reporting of said populations in the trial. If the inclusion and exclusion criteria 
are expected to have a negative effect on the recruitment or retention of 
underrepresented populations, the protocol must discuss why these criteria are 
necessary. 
 
m. The study protocol explicitly discusses how the results are or are not expected 
to be generalizable to affected beneficiary subpopulations. Separate  discussions in the protocol may be necessary for populations eligible for 
Medicare due to age, disability, or Medicaid eligibility. 
 
C.  Nationally Non-Covered Indications 
 
LAAC is non-covered for the treatment of NVAF when not furnished under CED 
according to the above-noted criteria. 
 
(This NCD last reviewed February 2016.) 
 
20.35 - Supervised Exercise Therapy (SET) for Symptomatic Peripheral 
Artery Disease (PAD) 
(Rev. 207, Issued: 05-11-18, Effective: 05-25-17, Implementation: 07-02-18) 
 
A.   General 
 
Research has shown supervised exercise therapy (SET) to be an effective, minimally 
invasive method to alleviate the most common symptom associated with peripheral artery 
disease (PAD)  intermittent claudication (IC).  SET has been shown to be significantly 
more effective than unsupervised exercise, and could prevent the progression of PAD and 
lower the risk of cardiovascular events that are prevalent in these patients.  SET has also 
been shown to perform at least as well as more invasive revascularization treatments that 
are covered by Medicare.    
 
B.   Nationally Covered Indications 
 
Effective for services performed on or after May 25, 2017, the Centers for Medicare & 
Medicaid Services has determined that the evidence is sufficient to cover SET for 
beneficiaries with IC for the treatment of symptomatic PAD.  Up to 36 sessions over a 
12-week period are covered if all of the following components of a SET program are met. 
The SET program must: 
 
  consist of sessions lasting 30-60 minutes comprising a therapeutic exercise-training 
program for PAD in patients with claudication;  
  be conducted in a physicians office;  
  be delivered by qualified auxiliary personnel necessary to ensure benefits exceed 
harms, and who are trained in exercise therapy for PAD; and  
  be under the direct supervision of a physician (as defined in 1861(r)(1)), physician 
assistant, or nurse practitioner/clinical nurse specialist (as identified in 1861(aa)(5)) 
who must be trained in both basic and advanced life support techniques. 
 
Beneficiaries must have a face-to-face visit with the physician responsible for PAD 
treatment to obtain the referral for SET.  At this visit, the beneficiary must receive 
information regarding cardiovascular disease and PAD risk factor reduction, which could 
include education, counseling, behavioral interventions, and outcome assessments.    
 
C.   Nationally Non-Covered Indications 
 
SET is non-covered for beneficiaries with absolute contraindications to exercise as 
determined by their primary physician.  
 
D.   Other 
 
Medicare Administrative Contractors (MACs) have the discretion to cover SET beyond 
the nationally covered 36 sessions over a 12-week period. MACs may cover an additional 
36 sessions over an extended period of time.  A second referral is required for these 
additional sessions 
 
(This NCD last reviewed May 2017.) 
 
30 - Complementary and Alternative Medicine 
(Rev. 1, 10-03-03) 
 
30.1 - Biofeedback Therapy 
(Rev. 1, 10-03-03) 
CIM 35-27 
 
Biofeedback therapy provides visual, auditory or other evidence of the status of certain 
body functions so that a person can exert voluntary control over the functions, and 
thereby alleviate an abnormal bodily condition.  Biofeedback therapy often uses electrical 
devices to transform bodily signals indicative of such functions as heart rate, blood 
pressure, skin temperature, salivation, peripheral vasomotor activity, and gross muscle 
tone into a tone or light, the loudness or brightness of which shows the extent of activity 
in the function being measured. 
 
Biofeedback therapy differs from electromyography which is a diagnostic procedure used 
to record and study the electrical properties of skeletal muscle.  An electromyography 
device may be used to provide feedback with certain types of biofeedback.  Biofeedback 
therapy is covered under Medicare only when it is reasonable and necessary for the 
individual patient for muscle re-education of specific muscle groups or for treating 
pathological muscle abnormalities of spasticity, incapacitating muscle spasm, or 
weakness, and more conventional treatments (heat, cold, massage, exercise, support) 
have not been successful.  This therapy is not covered for treatment of ordinary muscle 
tension states or for psychosomatic conditions.  (See the Medicare Benefit Policy 
Manual, Chapter 15, for general coverage requirements about physical therapy 
requirements.) 
 
30.1.1 - Biofeedback Therapy for the Treatment of Urinary 
Incontinence  (Rev. 1, 10-03-03) 
CIM 35-27.1 
 
Biofeedback Therapy for the Treatment of Urinary Incontinence 
 
This policy applies to biofeedback therapy rendered by a practitioner in an office or other 
facility setting. 
 
Biofeedback is covered for the treatment of stress and/or urge incontinence in cognitively 
intact patients who have failed a documented trial of pelvic muscle exercise (PME) 
training.  Biofeedback is not a treatment, per se, but a tool to help patients learn how to 
perform PME.  Biofeedback-assisted PME incorporates the use of an electronic or 
mechanical device to relay visual and/or auditory evidence of pelvic floor muscle tone, in 
order to improve awareness of pelvic floor musculature and to assist patients in the 
performance of PME. 
 
A failed trial of PME training is defined as no clinically significant improvement in 
urinary incontinence after completing four weeks of an ordered plan of pelvic muscle 
exercises to increase periurethral muscle strength. 
 
Contractors may decide whether or not to cover biofeedback as an initial treatment 
modality. 
 
Home use of biofeedback therapy is not covered. 
 
30.2 - Thermogenic Therapy 
(Rev. 1, 10-03-03) 
CIM 35-6 
 
Not Covered 
 
Thermogenic therapy which is the production of artificial fever, has been in use since 
1919 in the treatment of certain types of resistant infectious diseases, rheumatoid arthritis 
and Sydenhams chorea.  Regardless of the medium by which the fever is induced, this 
modality is not scientifically accepted for the treatment of any specific disease.  Since the 
advent of potent antibiotics, the procedure has for all practical purposes been replaced as 
a mode of treatment.  Therefore, thermogenic therapy is not considered reasonable and 
necessary for the treatment of an illness or injury as required by 1862(a)(1) of the Act.  
(Of course, where other covered services are needed and it would be reasonable and 
necessary that they be furnished on an inpatient hospital basis, payment would not be 
excluded for the inpatient stay, notwithstanding the fact that reimbursement may not be 
made for thermogenic therapy furnished during the hospital stay.) 
 
30.3 - Acupuncture 
(Rev. 10337, Issued: 08-27-20, Effective: 01-21-20, Implementation: 06-24 - 20 - A/B 
MACs; 10-05-20-SSM Edits; 01- 04-21 - BR 13 CWF only)   
A. General 
Acupuncture is the selection and manipulation of specific acupuncture points by a 
variety of needling and non-needling techniques. 
B. Nationally Covered Indications 
Effective for claims with dates of service on and after January 21, 2020, 
acupuncture is only covered for chronic low back pain under section 1862(a)(1)(A) 
of the Social Security Act (the Act). See National Coverage Determination section 
30.3.3 for specific coverage criteria. 
C. Nationally Non-Covered Indications 
 
Medicare reimbursement for acupuncture, as an anesthetic, or as an analgesic or for 
other therapeutic purposes, may not be made unless the specific indication is excepted.  
All indications for acupuncture outside of NCD section 30.3.3 remain non-covered. 
D. Other 
N/A 
(This NCD last reviewed January 2020.) 
 
 
 
30.3.1  Acupuncture for Fibromyalgia (Effective April 16, 2004) 
(Rev. 10337, Issued: 08-27-20, Effective: 01-21-20, Implementation: 06-24 - 20 - A/B 
MACs; 10-05-20-SSM Edits; 01- 04-21 - BR 13 CWF only) 
 
A. General 
Acupuncture is the selection and manipulation of specific acupuncture points by a 
variety of needling and non-needling techniques. 
B. Nationally Covered Indications 
N/A for acupuncture for fibromyalgia. 
C. Nationally Non-Covered Indications 
 
Effective for claims with dates of service on and after April 16, 2004, after careful 
reconsideration of its initial non-coverage determination for acupuncture, the Centers 
for Medicare & Medicaid Services (CMS) concludes that there is no convincing 
evidence for the use of acupuncture for pain relief in patients with fibromyalgia. Study 
design flaws presently prohibit assessing acupunctures utility for improving health  outcomes. Accordingly, CMS determines that acupuncture is not considered reasonable 
and necessary for the treatment of fibromyalgia within the meaning of 1862(a)(1) of 
the Social Security Act, and the national non-coverage determination for acupuncture 
for fibromyalgia continues. 
D. Other 
N/A 
(This NCD last reviewed April 2004.) 
 
30.3.2  Acupuncture for Osteoarthritis (Effective April 16, 2004) 
(Rev. 10337, Issued: 08-27-20, Effective: 01-21-20, Implementation: 06-24 - 20 - A/B 
MACs; 10-05-20-SSM Edits; 01- 04-21 - BR 13 CWF only) 
 
A. General 
Acupuncture is the selection and manipulation of specific acupuncture points by a 
variety of needling and non-needling techniques. 
B. Nationally Covered Indications 
N/A for acupuncture for osteoarthritis. 
C. Nationally Non-Covered Indications 
 
Effective for claims with dates of service on and after April 16, 2004, after careful 
reconsideration of its initial non-coverage determination for acupuncture, the Centers 
for Medicare & Medicaid Services (CMS) concludes that there is no convincing 
evidence for the use of acupuncture for pain relief in patients with osteoarthritis. Study 
design flaws presently prohibit assessing acupunctures utility for improving health 
outcomes. Accordingly, CMS determines that acupuncture is not considered reasonable 
and necessary for the treatment of osteoarthritis within the meaning of 1862(a)(1) of 
the Social Security Act, and the national non-coverage determination for acupuncture 
for osteoarthritis continues. 
D. Other 
N/A 
(This NCD last reviewed April 2004.) 
 
30.3.3  Acupuncture for Chronic Lower Back Pain (cLBP) 
(Rev. 10337, Issued: 08-27-20, Effective: 01-21-20, Implementation: 06-24 - 20 - A/B 
MACs; 10-05-20-SSM Edits; 01- 04-21 - BR 13 CWF only) 
A.  General  Acupuncture is the selection and manipulation of specific acupuncture points by a 
variety of needling and non-needling techniques. 
B. Nationally Covered Indications 
Effective for services performed on or after January, 21, 2020, CMS will cover 
acupuncture for Medicare patients with chronic Lower Back Pain (cLBP.) Up to 12 
visits in 90 days are covered for Medicare beneficiaries under the following 
circumstance: 
 
  For the purpose of this decision, cLBP is defined as: 
 
  Lasting 12 weeks or longer; 
o
  nonspecific, in that it has no identifiable systemic cause (i.e., not 
o
associated with metastatic, inflammatory, infectious, etc. disease); 
  not associated with surgery; and, 
o
  not associated with pregnancy. 
o
 
 An additional 8 sessions will be covered for those patients demonstrating an 
improvement.  
 
  No more than 20 acupuncture treatments may be administered annually.  
 
 Treatment must be discontinued if the patient is not improving or is regressing. 
Physicians (as defined in 1861(r)(1) of the Social Security Act (the Act) may furnish 
acupuncture in accordance with applicable state requirements. 
Physician assistants (PAs), nurse practitioners (NPs)/clinical nurse specialists 
(CNSs) (as identified in 1861(aa)(5) of the Act), and auxiliary personnel may 
furnish acupuncture if they meet all applicable state requirements and have: 
  a masters or doctoral level degree in acupuncture or Oriental Medicine from a 
school accredited by the Accreditation Commission on Acupuncture and Oriental 
Medicine (ACAOM); and, 
 
  a current, full, active, and unrestricted license to practice acupuncture in a State, 
Territory, or Commonwealth (i.e. Puerto Rico) of the United States, or District of 
Columbia. 
Auxiliary personnel furnishing acupuncture must be under the appropriate level of 
supervision of a physician, PA, or NP/CNS required by our regulations at 42 CFR 
 410.26 and 410.27. 
 
C. Nationally Non-Covered Indications  All types of acupuncture including dry needling for any condition other than cLBP are 
non-covered by Medicare.   
D. Other 
N/A 
(This NCD last reviewed January 2020.) 
 
30.4 - Electrosleep Therapy (RETIRED) 
(Rev. 11892; Issued: 03-09-23; Effective: 04-10-23; Implementation:04-10-23)   
 
Effective January 1, 2021, the Centers for Medicare & Medicaid Services 
determined that no national coverage determination (NCD) is appropriate at this 
time for Electrosleep Therapy. In the absence of an NCD, coverage determinations 
will be made by the Medicare Administrative Contractors under 1862(a)(1)(A) of 
the Social Security Act. 
 
30.5 - Transcendental Meditation 
(Rev. 1, 10-03-03) 
CIM 35-92 
 
Not Covered 
 
Transcendental meditation (TM) is a skill that is claimed to produce a state of rest and 
relaxation when practiced effectively.  Typically, patients are taught TM techniques over 
the course of several sessions by persons trained in TM.  The patient then uses the TM 
technique on his or her own to induce the relaxed state.  Proponents of TM have urged 
that Medicare cover the training of patients to practice TM when it is medically 
prescribed as treatment for mild hypertension, as adjunctive therapy in the treatment of 
essential hypertension, or as the sole or adjunctive treatment of anxiety and other 
psychological stress-related disorders. 
 
After review of this issue, CMS has concluded that the evidence concerning the medical 
efficacy of TM is incomplete at best and does not demonstrate effectiveness and that a 
professional level of skill is not required for the training of patients to engage in TM. 
 
Although many articles have been written about application of TM for patients with 
certain forms of hypertension and anxiety, there are no rigorous scientific studies that 
demonstrate the effectiveness of TM for use as an adjunct medical therapy for such 
conditions.  Accordingly, neither TM nor the training of patients for its use are covered 
under the Medicare program. 
 
30.6 - Intravenous Histamine Therapy 
(Rev. 1, 10-03-03) 
CIM 35-19 
  The only accepted and scientifically valid medical use of histamine is diagnostic, 
including tests to assess: 
 
  The ability of the stomach to secrete acid; 
  The integrity of peripheral sensory nerves (e.g., in leprosy); 
  The circulatory competency in limb extremities; and 
  The presence of a pheochromocytoma. 
 
However, there is no scientifically valid clinical evidence that histamine therapy is 
effective for any condition regardless of the method of administration, nor is it accepted 
or widely used by the medical profession.  Therefore, histamine therapy cannot be 
considered reasonable and necessary, and program payment for such therapy is not made. 
 
30.7 - Laetrile and Related Substances 
(Rev. 1, 10-03-03) 
CIM 45-10 
 
Not Covered 
 
Laetrile (and the other drugs called by the various terms mentioned below) have been 
used primarily in the treatment or control of cancer.  Although the terms Laetrile, 
laetrile, amygdalin, Sarcarcinase, vitamin B-17, and nitriloside have been used 
interchangeably, the chemical identity of the substances to which these terms refer has 
varied. 
 
The FDA has determined that neither Laetrile nor any other drug called by the various 
terms mentioned above, nor any other product which might be characterized as a 
nitriloside is generally recognized (by experts qualified by scientific training and 
experience to evaluate the safety and effectiveness of drugs) to be safe and effective for 
any therapeutic use.  Therefore, use of this drug cannot be considered to be reasonable 
and necessary within the meaning of 1862(a)(1) of the Act and program payment may 
not be made for its use or any services furnished in connection with its administration. 
 
A hospital stay only for the purpose of having laetrile (or any other drug called by the 
terms mentioned above) administered is not covered.  Also, program payment may not be 
made for laetrile (or other drug noted above) when it is used during the course of an 
otherwise covered hospital stay. 
 
30.8 - Cellular Therapy 
(Rev. 1, 10-03-03) 
CIM 35-5 
 
Not Covered 
 
Cellular therapy involves the practice of injecting humans with foreign proteins like the 
placenta or lungs of unborn lambs.  Cellular therapy is without scientific or statistical  evidence to document its therapeutic efficacy and, in fact, is considered a potentially 
dangerous practice.  Accordingly, cellular therapy is not considered reasonable and 
necessary within the meaning of 1862 (a) (1) of the Act. 
 
30.9 - Transillumination Light Scanning, or Diaphanography 
(Rev. 1, 10-03-03) 
CIM 50-46 
 
Not Covered 
 
While transillumination light scanning, or diaphanography, for use in detection of cancer 
and other diseases of the breast, appears safe, the usefulness of this instrumentation, when 
compared to existing modes of cancer and other breast disease detection, has not clearly 
been established.  Further study of this technology is needed to determine its role in 
breast cancer diagnosis.  Program payment may not be made for this procedure at this 
time. 
 
40 - Endocrine System and Metabolism 
(Rev. 1, 10-03-03) 
 
40.1 - Diabetes Outpatient Self-Management Training 
(Rev. 1, 10-03-03) 
CIM 80-2 
 
Refer to 42 CFR 410.140 - 410.146 for conditions that must be met for Medicare 
coverage. 
 
40.2 - Home Blood Glucose Monitors 
(Rev. 48, Issued:  03-17-06; Effective/Implementation Dates:  06-19-06) 
CIM 60-11 
 
There are several different types of blood glucose monitors that use reflectance meters to 
determine blood glucose levels.  Medicare coverage of these devices varies, with respect 
to both the type of device and the medical condition of the patient for whom the device is 
prescribed. 
 
Reflectance colorimeter devices used for measuring blood glucose levels in clinical 
settings are not covered as durable medical equipment for use in the home because their 
need for frequent professional re-calibration makes them unsuitable for home use. 
However, some types of blood glucose monitors which use a reflectance meter 
specifically designed for home use by diabetic patients may be covered as durable 
medical equipment, subject to the conditions and limitations described below. 
 
Blood glucose monitors are meter devices that read color changes produced on specially 
treated reagent strips by glucose concentrations in the patients blood.  The patient, using 
a disposable sterile lancet, draws a drop of blood, places it on a reagent strip and,  following instructions which may vary with the device used, inserts it into the device to 
obtain a reading.  Lancets, reagent strips, and other supplies necessary for the proper 
functioning of the device are also covered for patients for whom the device is indicated.  
Home blood glucose monitors enable certain patients to better control their blood glucose 
levels by frequently checking and appropriately contacting their attending physician for 
advice and treatment.  Studies indicate that the patients ability to carefully follow proper 
procedures is critical to obtaining satisfactory results with these devices. In addition, the 
cost of the devices, with their supplies, limits economical use to patients who must make 
frequent checks of their blood glucose levels.  Accordingly, coverage of home blood 
glucose monitors is limited to patients meeting the following conditions: 
 
1.  The patient has been diagnosed as having diabetes; 
 
2.  The patients physician states that the patient is capable of being trained to use the 
particular device prescribed in an appropriate manner.  In some cases, the patient may not 
be able to perform this function, but a responsible individual can be trained to use the 
equipment and monitor the patient to assure that the intended effect is achieved. This is 
permissible if the record is properly documented by the patients physician; and 
 
3.  The device is designed for home rather than clinical use. 
 
There is also a blood glucose monitoring system designed especially for use by those 
with visual impairments.  The monitors used in such systems are identical in terms of 
reliability and sensitivity to the standard blood glucose monitors described above.  They 
differ by having such features as voice synthesizers, automatic timers, and specially 
designed arrangements of supplies and materials to enable the visually impaired to use 
the equipment without assistance. 
 
These special blood glucose monitoring systems are covered under Medicare if the 
following conditions are met: 
 
  The patient and device meet the three conditions listed above for coverage of 
standard home blood glucose monitors; and 
  
  The patients physician certifies that he or she has a visual impairment severe 
enough to require use of this special monitoring system. 
 
The additional features and equipment of these special systems justify a higher 
reimbursement amount than allowed for standard blood glucose monitors.  Separately 
identify claims for such devices and establish a separate reimbursement amount for them. 
 
40.3 - Closed-Loop Blood Glucose Control Device (CBGCD) 
(Rev. 1, 10-03-03) 
CIM 35-70 
 
The closed-loop blood glucose control device (CBGCD) is a hospital bedside device  designed for short-term management of patients with insulin dependent diabetes mellitus 
(Type I).  It consists of a rapid on-line glucose analyzer; a computer with a controller for 
the calculation and control of the infusion of either insulin or dextrose; a multi-channel 
infusion system; and a printer designed to record continuous glucose values and to 
provide cumulative totals of the substances infused.  Its primary use is for the 
stabilization of Type I diabetics during periods of stress, such as trauma, labor and 
delivery, and surgery, when there are wide fluctuations in blood sugar levels.  It serves to 
temporarily correct abnormal blood glucose levels (hyper- or hypo-glycemia) and this 
correction is made by infusion of either insulin or dextrose.  Its use is generally limited to 
a 24- to 48-hour period because of potential complications; (e.g., sepsis, thromboses, and 
nonportability, etc.).  The CBGCD requires specialized training for use and interpretation 
of its diagnostic and therapeutic contribution and continuous observation by specially 
trained medical personnel. 
 
Use of the CBGCD is covered for short-term management of insulin dependent diabetics 
in crisis situations, in a hospital inpatient setting, and only under the direction of specially 
trained medical personnel. 
 
40.4 - Insulin Syringe 
(Rev. 1, 10-03-03) 
CIM 45-3 
 
Medical supplies are covered under 1861(s)(2)(A) of the Act only when they are 
furnished incident to a physicians professional services.  To be covered under this 
provision an insulin syringe must have been used by the physician or under his/her direct 
personal supervision, and the insulin injection must have been given in an emergency 
situation (e.g., diabetic coma). 
 
The use of an insulin syringe by a diabetic would not meet the requirements of 
1861(s)(2)(A) of the Act.  See the Medicare Benefit Policy Manual, Chapter 15, 
Covered Medical and Other Health Services, 30. 
 
40.5  Treatment of Obesity 
(Rev. 158, Issued: 12-23-13, Effective: 09-24-13, Implementation: 12-17-13) 
 
Please note section 40.5 has been removed from the NCD Manual and incorporated into 
NCD 100.1. 
 
40.7  Outpatient Intravenous Insulin Treatment (Effective December 
23, 2009) 
(Rev. 117, Issued: 03-09-10, Effective Date: 12-23-09; Implementation Date: 04-05-
10) 
 
A.  General 
 
The term outpatient intravenous (IV) insulin therapy (OIVIT) refers to an outpatient  regimen that integrates pulsatile or continuous intravenous infusion of insulin via any 
means, guided by the results of measurement of: 
 
  respiratory quotient; and/or 
  urine urea nitrogen (UUN); and/or 
  arterial, venous, or capillary glucose; and/or 
  potassium concentration; and 
 
performed in scheduled recurring periodic intermittent episodes. 
 
This regimen is also sometimes termed Cellular Activation Therapy (CAT), Chronic 
Intermittent Intravenous Insulin Therapy (CIIT), Hepatic Activation Therapy (HAT), 
Intercellular Activation Therapy (iCAT), Metabolic Activation Therapy (MAT), Pulsatile 
Intravenous Insulin Treatment (PIVIT), Pulse Insulin Therapy (PIT), and Pulsatile 
Therapy (PT). 
 
In OIVIT, insulin is intravenously administered in the outpatient setting for a variety of 
indications. Most commonly, it is delivered in pulses, but it may be delivered as a more 
conventional drip solution. The insulin administration is adjunctive to the patients 
routine diabetic management regimen (oral agent or insulin-based) or other disease 
management regimen, typically performed on an intermittent basis (often weekly), and 
frequently performed chronically without duration limits. Glucose or other carbohydrate 
is available ad libitum (in accordance with patient desire). 
 
B.  Nationally Covered Indications 
 
N/A 
 
C.  Nationally Non-Covered Indications 
 
Effective for claims with dates of service on and after December 23, 2009, the Centers 
for Medicare and Medicaid Services (CMS) determines that the evidence does not 
support a conclusion that OIVIT improves health outcomes in Medicare beneficiaries. 
Therefore, CMS has determined that OIVIT is not reasonable and necessary for any 
indication under section 1862(a)(1)(A) of the Social Security Act.  Services comprising 
an OIVIT regimen are nationally non-covered under Medicare when furnished pursuant 
to an OIVIT regimen (see subsection A. above). 
 
D.  Other 
 
Individual components of OIVIT may have medical uses in conventional treatment 
regimens for diabetes and other conditions.  Coverage for such other uses may be 
determined by other local or national Medicare determinations, and do not pertain to 
OIVIT.  For example, see Pub. 100-03, NCD Manual, Section 40.2, Home Blood Glucose 
Monitors, Section 40.3, Closed-loop Blood Glucose Control Devices (CBGCD), Section 
190.20, Blood Glucose Testing, and Section 280.14, Infusion Pumps, as well as Pub. 100- 04, Claims Processing Manual, Chapter 18, Section 90, Diabetics Screening. 
 
(This NCD last reviewed December 2009.) 
 
50 - Ear, Nose and Throat (ENT) 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
50.1 - Speech Generating Devices 
(Rev. 184, Issued: 08-21-15, Effective: 07-29-15, Implementation: 09-21-15) 
 
A.  General 
 
Speech generating devices are considered to fall within the durable medical equipment 
(DME) benefit category established by 1861(n) of the Social Security Act.  They are 
covered for patients who suffer from a severe speech impairment and have a medical 
condition that warrants the use of a device based on the following definitions. 
 
Speech generating devices are defined as durable medical equipment that provides an 
individual who has a severe speech impairment with the ability to meet his or her 
functional, speaking needs.  Speech generating devices are speech aids consisting of 
devices or software that generate speech and are used solely by the individual who has a 
severe speech impairment.  The speech is generated using one of the following methods: 
 
  digitized audible/verbal speech output, using prerecorded messages; 
 
  synthesized audible/verbal speech output which requires message formulation by 
spelling and device access by physical contact with the device-direct selection 
techniques; 
 
  synthesized audible/verbal speech output which permits multiple methods of 
message formulation and multiple methods of device access; or 
 
  software that allows a computer or other electronic device to generate 
audible/verbal speech. 
 
Other covered features of the device include the capability to generate email, text, or 
phone messages to allow the patient to speak or communicate remotely, as well as the 
capability to download updates to the covered features of the device from the 
manufacturer or supplier of the device. 
 
If a speech generating device is limited to use by a patient with a severe speech 
impairment and is primarily used for the purpose of generating speech, it is not necessary 
for the device to be dedicated only to audible/verbal speech output to be considered 
DME.  Computers and tablets are generally not considered DME because they are useful 
in the absence of an illness or injury.   
B.  Nationally Covered Indications 
 
N/A 
 
C.  Nationally Non-Covered Indications 
 
Internet or phone services or any modification to a patients home to allow use of the 
speech generating device are not covered by Medicare because such services or 
modifications could be used for non-medical equipment such as standard phones or 
personal computers.  In addition, specific features of a speech generating device that are 
not used by the individual who has a severe speech impairment to meet his or her 
functional speaking needs are not covered.  This would include any computing hardware 
or software not necessary to allow for generation of audible/verbal speech, email, text or 
phone messages, such as hardware or software used to create documents and spreadsheets 
or play games or music, and any other function a computer can perform that is not 
directly related to meeting the functional speaking communication needs of the patient, 
including video communications or conferencing.  These features of a speech generating 
device do not fall within the scope of  1861(n) of the Social Security Act and the cost of 
these features are the responsibility of the beneficiary.  Suppliers of speech generating 
devices are encouraged to furnish the beneficiary with a voluntary Advance Beneficiary 
Notice (ABN), or similar notice, which informs that these features are not covered and to 
alert the beneficiary of the expense of these features. 
 
D.  Other 
 
A/B MACs acting within their respective jurisdictions have discretion to cover or not 
cover speech generating devices based on their individual reasonable and necessary 
determinations. 
 
(This NCD last reviewed July 2015.) 
 
50.2 - Electronic Speech Aids 
(Rev. 1, 10-03-03) 
CIM 65-5 
 
Electronic speech aids are covered under Part B as prosthetic devices when the patient 
has had a laryngectomy or his larynx is permanently inoperative.  There are two types of 
speech aids.  One operates by placing a vibrating head against the throat; the other 
amplifies sound waves through a tube which is inserted into the users mouth.  A patient 
who has had radical neck surgery and/or extensive radiation to the anterior part of the 
neck would generally be able to use only the oral tube model or one of the more 
sensitive and more expensive throat contact devices. 
 
Cross-reference: 
  The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health 
Services, 120. 
 
 
 
50.3 - Cochlear Implantation (Effective April 4, 2005) 
(Rev. 11875; Issued:02-23-23; Effective: 09-26-22; Implementation: 03-24-23) 
 
A.   General 
 
A cochlear implant device is an electronic instrument, part of which is implanted 
surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the 
individual to capture, analyze, and code sound. Cochlear implant devices are available in 
single-channel and multi-channel models. The purpose of implanting the device is to 
provide awareness and identification of sounds and to facilitate communication for 
persons who are moderately to profoundly hearing impaired. 
 
B.   Nationally Covered Indications 
 
Effective for services performed on or after September 26, 2022, cochlear implantation 
may be covered for treatment of bilateral pre- or post-linguistic, sensorineural, moderate-
to-profound hearing loss in individuals who demonstrate limited benefit from 
amplification. Limited benefit from amplification is defined by test scores of less than or 
equal to 60% correct in the best-aided listening condition on recorded tests of open-set 
sentence recognition. Patients must meet all of the following criteria. 
  Diagnosis of bilateral moderate-to-profound sensorineural hearing impairment 
with limited benefit from appropriate hearing (or vibrotactile) aids; 
  Cognitive ability to use auditory clues and a willingness to undergo an extended 
program of rehabilitation; 
  Freedom from middle ear infection, an accessible cochlear lumen that is 
structurally suited to implantation, and freedom from lesions in the auditory nerve 
and acoustic areas of the central nervous system; 
  No contraindications to surgery; and 
  The device must be used in accordance with Food and Drug Administration 
(FDA)-approved labeling. 
C.   Nationally Non-Covered Indications 
 
Medicare beneficiaries not meeting all of the coverage criteria for cochlear implantation 
listed in Section B are deemed not eligible for Medicare coverage except as described in 
Section D below. 
 
D.    Other 
    CMS may provide coverage of cochlear implants for beneficiaries not meeting the 
coverage criteria listed in Section B when performed in the context of FDA-approved 
category B investigational device exemption clinical trials as defined at 42 CFR 405.201 
or as a routine cost in clinical trials under section 310.1 of the National Coverage 
Determinations Manual titled Routine Costs in Clinical Trials. 
 
(This NCD last reviewed September 2022)  
 
50.4 - Tracheostomy Speaking Valve 
(Rev. 1, 10-03-03) 
CIM 65-16 
 
A trachea tube has been determined to satisfy the definition of a prosthetic device, and 
the tracheostomy speaking valve is an add on to the trachea tube which may be 
considered a medically necessary accessory that enhances the function of the tube.  In 
other words, it makes the system a better prosthesis.  As such, a tracheostomy speaking 
valve is covered as an element of the trachea tube which makes the tube more effective. 
 
50.5 - Oxygen Treatment of Inner Ear/Carbon Therapy 
(Rev. 1, 10-03-03) 
CIM 35-29 
 
Not Covered 
 
Oxygen (95 percent) and carbon dioxide (5 percent) inhalation therapy for inner ear 
disease, such as endolymphatic hydrops and fluctuant hearing loss, is not reasonable and 
necessary.  The therapeutic benefit deriving from this procedure is highly questionable. 
 
50.6 - Tinnitus Masking (RETIRED) 
(Rev. 11892; Issued: 03-09-23; Effective: 04-10-23; Implementation:04-10-23)   
 
This section of the NCD Manual was retired December 18, 2014. 
 
50.7 - Cochleostomy With Neurovascular Transplant for Menieres 
Disease 
(Rev. 1, 10-03-03) 
CIM 35-50 
 
Not Covered 
 
Menieres disease (or syndrome) is a common cause of paroxysmal vertigo.  Menieres 
syndrome is usually treated medically.  When medical treatment fails, surgical treatment 
may be required. 
 
While there are two recognized surgical procedures used in treating Menieres disease 
(decompression of the endolymphatic hydrops and labyrinthectomy), there is no scientific  evidence supporting the safety and effectiveness of cochleostomy with neurovascular 
transplant in treatment of Menieres syndrome.  Accordingly, Medicare does not cover 
cochleostomy with neurovascular transplant for treatment of Menieres disease. 
 
50.8 - Ultrasonic Surgery 
(Rev. 1, 10-03-03) 
CIM 35-4 
 
Reimbursement may be made for ultrasonic surgery when required in the treatment of 
patients with severe and recurrent episodes of vertigo due to Menieres syndrome.  This 
procedure utilizes a machine that produces ultrasonic waves of high intensity and 
frequency that selectively irradiate certain portions of the inner ear thereby destroying the 
tissue.  The procedure is usually done under local anesthesia, and requires the services of 
a surgeon and another individual who is responsible for calibrating the electrical 
equipment, and who assists in observing certain physical changes (e.g., movement of the 
eyes, nystagmus") indicative of inner ear reaction to the ultrasonic destruction.  Except 
in rare instances the desired result is achieved with one treatment.  At present, there are 
two different approaches being used to apply the ultrasound to the inner ear: one through 
the lateral semicircular canal and, more recently, a simpler approach from a technical 
viewpoint, through the round window. 
 
60 - Emergency Medicine 
(Rev. 1, 10-03-03) 
 
No coverage determinations. 
 
70 - Evaluation and Management of Patients - Office/hospital/home 
(Rev. 1, 10-03-03) 
 
70.1 - Consultations With a Beneficiarys Family and Associates 
(Rev. 1, 10-03-03) 
CIM 35-14 
 
In certain types of medical conditions, including when a patient is withdrawn and 
uncommunicative due to a mental disorder or comatose, the physician may contact 
relatives and close associates to secure background information to assist in diagnosis and 
treatment planning.  When a physician contacts his patients relatives or associates for 
this purpose, expenses of such interviews are properly chargeable as physicians services 
to the patient on whose behalf the information was secured.  If the beneficiary is not an 
inpatient of a hospital, Part B reimbursement for such an interview is subject to the 
special limitation on payments for physicians services in connection with mental, 
psychoneurotic, and personality disorders. 
 
A physician may also have contacts with a patients family and associates for purposes 
other than securing background information.  In some cases, the physician will provide 
counseling to members of the household.  Family counseling services are covered only  where the primary purpose of such counseling is the treatment of the patients condition. 
 
For example, two situations where family counseling services would be appropriate are 
as follows:  (1) where there is a need to observe the patients interaction with family 
members; and/or (2) where there is a need to assess the capability of and assist the family 
members in aiding in the management of the patient.  Counseling principally concerned 
with the effects of the patients condition on the individual being interviewed would not 
be reimbursable as part of the physicians personal services to the patient.  While to a 
limited degree, the counseling described in the second situation may be used to modify 
the behavior of the family members, such services nevertheless are covered because they 
relate primarily to the management of the patients problems and not to the treatment of 
the family members problems. 
 
Cross-references: 
 
The Medicare Benefit Policy Manual, Chapter 6, Hospital Services Covered Under Part 
B,20. 
 
The Medicare Claims Processing Manual, Chapter 12, Physician/Practitioner Billing, 
10. 
 
The Medicare General Information, Eligibility, and Entitlement Manual, Chapter 3, 
Deductibles, Coinsurance Amounts, and Payment Limitations, 30. 
 
70.2 - Consultation Services Rendered by a Podiatrist in a Skilled 
Nursing Facility 
(Rev. 1, 10-03-03) 
CIM 50-8 
 
Consultation services rendered by a podiatrist in a skilled nursing facility are covered if 
the services are reasonable and necessary and do not come within any of the specific 
statutory exclusions.  Section 1862(a)(13) of the Act excludes payment for the treatment 
of flat foot conditions, the treatment of subluxations of the foot, and routine foot care.  To 
determine whether the consultation comes within the foot care exclusions, apply the same 
rule as for initial diagnostic examinations, i.e., where services are performed in 
connection with specific symptoms or complaints which suggest the need for, covered 
services, the services are covered regardless of the resulting diagnosis.  The exclusion of 
routine physician examinations is also pertinent and would generally exclude podiatric 
consultation performed on all patients in a skilled nursing facility on a routine basis for 
screening purposes, except in those cases where a specific foot ailment is involved. 
Section 1862(a)(7) of the Act excludes payment for routine physical checkups.  (See the 
Medicare Benefit Policy Manual, Chapter 16, General Exclusions from Coverage, 90 
and 100.) 
 
70.2.1 - Services Provided for the Diagnosis and Treatment of Diabetic 
Sensory Neuropathy with Loss of Protective Sensation (aka Diabetic  Peripheral Neuropathy) 
(Rev. 1, 10-03-03) 
CIM 50-8.1 
 
Presently, peripheral neuropathy, or diabetic sensory neuropathy, is the most common 
factor leading to amputation in people with diabetes.  In diabetes, sensory neuropathy is 
an anatomically diffuse process primarily affecting sensory and autonomic fibers; 
however, distal motor findings may be present in advanced cases.  Long nerves are 
affected first, with symptoms typically beginning insidiously in the toes and then 
advancing proximally.  This leads to loss of protective sensation (LOPS), whereby a 
person is unable to feel minor trauma from mechanical, thermal, or chemical sources.  
When foot lesions are present, the reduction in autonomic nerve functions may also 
inhibit wound healing. 
 
Diabetic sensory neuropathy with LOPS is a localized illness of the feet and falls within 
the regulations exception to the general exclusionary rule (see 42 CFR 411.15(l)(1)(i)).  
Foot exams for people with diabetic sensory neuropathy with LOPS are reasonable and 
necessary to allow for early intervention in serious complications that typically afflict 
diabetics with the disease. 
 
Effective for services furnished on or after July 1, 2002, Medicare covers, as a physician 
service, an evaluation (examination and treatment) of the feet no more often than every 
six months for individuals with a documented diagnosis of diabetic sensory neuropathy 
and LOPS, as long as the beneficiary has not seen a foot care specialist for some other 
reason in the interim.  LOPS shall be diagnosed through sensory testing with the 5.07 
monofilament using established guidelines, such as those developed by the National 
Institute of Diabetes and Digestive and Kidney Diseases guidelines.  Five sites should be 
tested on the plantar surface of each foot, according to the National Institute of Diabetes 
and Digestive and Kidney Diseases guidelines.  The areas must be tested randomly since 
the loss of protective sensation may be patchy in distribution, and the patient may get 
clues if the test is done rhythmically.  Heavily callused areas should be avoided.  As 
suggested by the American Podiatric Medicine Association, an absence of sensation at 
two or more sites out of 5 tested on either foot when tested with the 5.07 Semmes-
Weinstein monofilament must be present and documented to diagnose peripheral 
neuropathy with loss of protective sensation. 
 
The examination includes: 
 
1.  A patient history, and 
 
2.  A physical examination that must consist of at least the following elements: 
 
  Visual inspection of forefoot and hindfoot (including toe web spaces); 
  Evaluation of protective sensation; 
  Evaluation of foot structure and biomechanics; 
  Evaluation of vascular status and skin integrity;    Evaluation of the need for special footwear; and 
 
3  Patient education. 
 
A.  Treatment includes, but is not limited to:  
 
  Local care of superficial wounds; 
  Debridement of corns and calluses; and  
  Trimming and debridement of nails. 
 
The diagnosis of diabetic sensory neuropathy with LOPS should be established and 
documented prior to coverage of foot care.  Other causes of peripheral neuropathy should 
be considered and investigated by the primary care physician prior to initiating or 
referring for foot care for persons with LOPS. 
 
70.3 - Physicians Office within an Institution - Coverage of Services 
and Supplies Incident to a Physicians Services 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
Coverage of Services and Supplies Incident to a Physicians Services 
 
Where a physician establishes an office within a nursing home or other institution, 
coverage of services and supplies furnished in the office must be determined in 
accordance with the incident to a physicians professional service provision (see the 
Medicare Benefit Policy Manual, Chapter 6, Hospital Services Covered Under Part B, 
20.4.1 or the Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other 
Health Services, 60.1) as in any physicians office. A physicians office within an 
institution must be confined to a separately identified part of the facility which is used 
solely as the physicians office and cannot be construed to extend throughout the entire 
institution.  Thus, services performed outside the office area would be subject to the 
coverage rules applicable to services furnished outside the office setting. 
 
In order to accurately apply the criteria in the Medicare Benefit Policy Manual, Chapters 
6, 20.4.1, or Chapter 15, Covered Medical and Other Health Services, 60.1, the A/B 
MAC gives consideration to the physical proximity of the institution and physicians 
office.  When his office is located within a facility, a physician may not be reimbursed for 
services, supplies, and use of equipment which fall outside the scope of services 
commonly furnished in physicians offices generally, even though such services may 
be furnished in his institutional office. Additionally, make a distinction between the 
physicians office practice and the institution, especially when the physician is 
administrator or owner of the facility.  Thus, for their services to be covered under the 
criteria in the Medicare Benefit Policy Manual, Chapter 6, 20.4.1, or the Medicare 
Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 
60.1, the auxiliary medical personnel must be members of the office staff rather than of 
the institutions staff, and the cost of supplies must represent an expense to the  physicians office practice.  Finally, services performed by the employees of the 
physician outside the office area must be directly supervised by the physician; his 
presence in the facility as a whole would not suffice to meet this requirement.  (In any 
setting, of course, supervision of auxiliary personnel in and of itself is not considered a 
physicians professional service to which the services of the auxiliary personnel could 
be an incidental part, i.e., in addition to supervision, the physician must perform or have 
performed a personal professional service to the patient to which the services of the 
auxiliary personnel could be considered an incidental part.)  Denials for failure to meet 
any of these requirements would be based on 1861(s)(2)(A) of the Social Security Act. 
 
Establishment of an office within an institution would not modify rules otherwise 
applicable for determining coverage of the physicians personal professional services 
within the institution.  However, in view of the opportunity afforded to a physician who 
maintains such an office for rendering services to a sizable number of patients in a short 
period of time or for performing frequent services for the same patient, claims for 
physicians services rendered under such circumstances would require careful evaluation 
by the A/B MAC to assure that payment is made only for services that are reasonable and 
necessary. 
 
Cross-reference: 
 
The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health 
Services. 
 
The Medicare Benefit Policy Manual, Chapter 6, Hospital Services Covered Under Part 
B, 20.4.1. 
 
70.4 - Pronouncement of Death 
(Rev. 1, 10-03-03) 
CIM 50-19 
 
According to established legal principles, an individual is not considered deceased until 
there has been official pronouncement of death.  An individual is therefore considered to 
have expired as of the time he/she is pronounced dead by a person who is legally 
authorized to make such a pronouncement, usually a physician.  Reasonable and 
necessary medical services rendered up to and including pronouncement of death by a 
physician are covered diagnostic or therapeutic services. 
 
70.5 - Hospital and Skilled Nursing Facility Admission Diagnostic 
Procedures 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
These instructions describe the application of the reasonable and necessary payment 
exclusion to diagnostic procedures, such as chest x-rays, urinalysis, etc. provided to 
patients upon admission to a hospital or skilled nursing facility.   
The major factors which support a determination that a diagnostic procedure performed 
as part of the admitting procedure to a hospital or skilled nursing facility is reasonable 
and necessary, are: 
 
A.  The test is specifically ordered by the admitting physician (or a hospital or skilled 
nursing facility staff physician having responsibility for the patient where there is no 
admitting physician):  i.e., it is not furnished under the standing orders of a physician for 
his patients; 
 
B.  The test is medically necessary for the diagnosis or treatment of the individual 
patients condition; and 
 
C.  The test does not unnecessarily duplicate the same test performed on an outpatient 
basis prior to admission or performed in connection with a recent hospital or skilled 
nursing facility admission. 
 
Where the A/B MAC has not already done so, consult with the Quality Improvement 
Organizations (QIOs) to obtain information gathered by the QIOs on a sample basis as to 
whether x-rays and diagnostic tests are being specifically ordered as described under 
subsection (A). 
 
80 - Eye 
(Rev. 1, 10-03-03) 
 
80.1 - Hydrophilic Contact Lens for Corneal Bandage 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
Some hydrophilic contact lenses are used as moist corneal bandages for the treatment of 
acute or chronic corneal pathology, such as bulbous keratopathy, dry eyes, corneal ulcers 
and erosion, keratitis, corneal edema, descemetocele, corneal ectasis, Moorens ulcer, 
anterior corneal dystrophy, neurotrophic keratoconjunctivitis, and for other therapeutic 
reasons. 
 
Payment may be made under 1861(s)(2) of the Social Security Act for a hydrophilic 
contact lens approved by the Food and Drug Administration (FDA) and used as a supply 
incident to a physicians service.  Payment for the lens is included in the payment for the 
physicians service to which the lens is incident.  A/B MACs are authorized to accept an 
FDA letter of approval or other FDA published material as evidence of FDA approval.  
(See 80.4 for coverage of a hydrophilic contact lens as a prosthetic device.)  See the 
Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health 
Services, and the Medicare Benefit Policy Manual, Chapter 6, Hospital Services 
Covered Under Part B, 20.4. 
 
80.2 - Photodynamic Therapy  (Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
Photodynamic therapy is a medical procedure which involves the infusion of a 
photosensitive (light-activated) drug with a very specific absorption peak. This drug is 
chemically designed to have a unique affinity for the diseased tissue intended for 
treatment. Once introduced to the body, the drug accumulates and is retained in diseased 
tissue to a greater degree than in normal tissue. Infusion is followed by the targeted 
irradiation of this tissue with a non-thermal laser, calibrated to emit light at a wavelength 
that corresponds to the drugs absorption peak. The drug then becomes active and locally 
treats the diseased tissue.  
 
Ocular Photodynamic Therapy (OPT)  
 
Ocular Photodynamic Therapy (OPT) is used in the treatment of ophthalmologic 
diseases. OPT is only covered when used in conjunction with verteporfin (see section 
80.3, Photosensitive Drugs).  
 
  Classic Subfoveal Choroidal Neovascular (CNV) Lesions - OPT is covered with 
a diagnosis of neovascular age-related macular degeneration (AMD) with 
predominately classic subfoveal choroidal neovascular (CNV) lesions (where 
the area of classic CNV occupies 50% of the area of the entire lesion) at the 
initial visit as determined by a fluorescein angiogram (FA). Subsequent follow-
up visits will require either an optical coherence tomography or an FA to access 
treatment response. There are no requirements regarding visual acuity, lesion 
size, and number of re-treatments.  
 
  Occult Subfoveal CNV Lesions - OPT is non-covered for patients with a 
diagnosis of AMD with occult and no classic CNV lesions.  
 
Other Conditions - Use of OPT with verteporfin for other types of AMD (e.g., patients 
with minimally classic CNV lesions, atrophic, or dry AMD) is non-covered. OPT with 
verteporfin for other ocular indications such as pathologic myopia or presumed ocular 
histoplasmosis syndrome, is eligible for coverage through individual A/B MAC 
discretion. 
 
80.2.1 - Ocular Photodynamic Therapy (OPT) - Effective April 3, 2013 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
A.  General  
 
Ocular Photodynamic Therapy (OPT) is used in the treatment of ophthalmologic 
diseases; specifically, for age-related macular degeneration (AMD), a common eye 
disease among the elderly. OPT involves the infusion of an intravenous photosensitizing  drug called verteporfin followed by exposure to a laser. OPT is only covered when used 
in conjunction with verteporfin.  
 
Effective July 1, 2001, OPT with verteporfin was approved for a diagnosis of neovascular 
AMD with predominately classic subfoveal choroidal neovascularization (CNV) lesions 
(where the area of classic CNV occupies 50% of the area of the entire lesion) at the 
initial visit as determined by a fluorescein angiogram (FA). 
 
On October 17, 2001, the Centers for Medicare & Medicaid Services (CMS) announced 
its intent to cover OPT with verteporfin for AMD patients with occult and no classic 
subfoveal CNV as determined by an FA. The October 17, 2001, decision was never 
implemented. 
 
On March 28, 2002, after thorough review and reconsideration of the October 17, 2001, 
intent to cover policy, CMS determined that the current non-coverage policy for OPT for 
verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by 
an FA should remain in effect. 
 
Effective August 20, 2002, CMS issued a non-coverage instruction for OPT with 
verteporfin for AMD patients with occult and no classic subfoveal CNV as determined by 
an FA. 
 
B.  Nationally Covered Indications  
 
Effective April 1, 2004, OPT with verteporfin continues to be approved for a diagnosis of 
neovascular AMD with predominately classic subfoveal CNV lesions (where the area of 
classic CNV occupies 50% of the area of the entire lesion) at the initial visit as 
determined by an FA. (CNV lesions are comprised of classic and/or occult components.) 
Subsequent follow-up visits require either an optical coherence tomography (OCT) 
(effective April 3. 2013) or an FA (effective April 1, 2004) to access treatment response. 
There are no requirements regarding visual acuity, lesion size, and number of re-
treatments when treating predominantly classic lesions. 
 
In addition, after thorough review and reconsideration of the August 20, 2002, non-
coverage policy, CMS determines that the evidence is adequate to conclude that OPT 
with verteporfin is reasonable and necessary for treating:  
 
1.   Subfoveal occult with no classic CNV associated with AMD; and,  
 
2.   Subfoveal minimally classic CNV (where the area of classic CNV occupies <50% 
of the area of the entire lesion) associated with AMD.  
 
The above 2 indications are considered reasonable and necessary only when: 
 
1.  The lesions are small (4 disk areas or less in size) at the time of initial treatment 
or within the 3 months prior to initial treatment; and,    
2.   The lesions have shown evidence of progression within the 3 months prior to 
initial treatment. Evidence of progression must be documented by deterioration of 
visual acuity (at least 5 letters on a standard eye examination chart), lesion growth 
(an increase in at least 1 disk area), or the appearance of blood associated with the 
lesion. 
 
C.  Nationally Non-Covered Indications  
 
Other uses of OPT with verteporfin to treat AMD not already addressed by CMS will 
continue to be non-covered. These include, but are not limited to, the following AMD 
indications: 
 
  Juxtafoveal or extrafoveal CNV lesions (lesions outside the fovea),  
  Inability to obtain a fluorescein angiogram,  
  Atrophic or dry AMD.  
 
D.  Other 
 
The OPT with verteporfin for other ocular indications, such as pathologic myopia or 
presumed ocular histoplasmosis syndrome, continue to be eligible for local coverage 
determinations through individual A/B MAC discretion. 
 
80.3 - Photosensitive Drugs 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
Photosensitive drugs are the light-sensitive agents used in photodynamic therapy. Once 
introduced into the body, these drugs selectively identify and adhere to diseased tissue. 
The drugs remain inactive until they are exposed to a specific wavelength of light, by 
means of a laser, that corresponds to their absorption peak. The activation of a 
photosensitive drug results in a photochemical reaction which treats the diseased tissue 
without affecting surrounding normal tissue. 
 
Verteporfin  
 
Verteporfin, a benzoporphyrin derivative, is an intravenous lipophilic photosensitive drug 
with an absorption peak of 690 nm. This drug was first approved by the Food and Drug 
Administration on April 12, 2000, and subsequently, approved for inclusion in the United 
States Pharmacopoeia on July 18, 2000, meeting Medicares definition of a drug when 
used in conjunction with ocular photodynamic therapy (OPT) (see section 80.2, 
Photodynamic Therapy) when furnished intravenously incident to a physicians 
service. For patients with age-related macular degeneration (AMD), verteporfin is only 
covered with a diagnosis of neovascular AMD with predominately classic subfoveal 
choroidal neovascular (CNV) lesions (where the area of classic CNV occupies 50% of 
the area of the entire lesion) at the initial visit as determined by a fluorescein angiogram  (FA). Subsequent follow-up visits will require either an optical coherence tomography or 
an FA to access treatment response. OPT with verteporfin is covered for the above 
indication and will remain non-covered for all other indications related to AMD (see 
section 80.2). OPT with verteporfin for use in non-AMD conditions is eligible for 
coverage through individual A/B MAC discretion. 
 
80.3.1 - Verteporfin - Effective April 3, 2013 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
A.  General 
 
Verteporfin, a benzoporphyrin derivative, is an intravenous lipophilic photosensitive drug 
with an absorption peak of 690 nm. Verteporfin was first approved by the Food and Drug 
Administration on April 12, 2000, and subsequently approved for inclusion in the United 
States Pharmacopoeia on July 18, 2000, meeting Medicares definition of a drug as 
defined under 1861(t)(1) of the Social Security Act. Verteporfin is only covered when 
used in conjunction with ocular photodynamic therapy (OPT) when furnished 
intravenously incident to a physicians service.  
 
B.  Nationally Covered Indications 
 
Effective April 1, 2004, OPT with verteporfin is covered for patients with a diagnosis of 
neovascular age-related macular degeneration (AMD) with:  
 
  Predominately classic subfoveal choroidal neovascularization (CNV) lesions (where 
the area of classic CNV occupies 50% of the area of the entire lesion) at the initial 
visit as determined by a fluorescein angiogram (FA). (CNV lesions are comprised of 
classic and/or occult components.) Subsequent follow-up visits require either an 
optical coherence tomography (effective April 3, 2013) or an FA (effective April 1, 
2004) to access treatment response.  
 
There are no requirements regarding visual acuity, lesion size, and number of 
retreatments when treating predominantly classic lesions.  
 
  Subfoveal occult with no classic CNV associated with AMD.  
 
  Subfoveal minimally classic CNV (where the area of classic CNV occupies <50% of 
the area of the entire lesion) associated with AMD.  
 
The above 2 indications are considered reasonable and necessary only when:  
 
1.  The lesions are small (4 disk areas or less in size) at the time of initial treatment 
or within the 3 months prior to initial treatment; and,  
  2.   The lesions have shown evidence of progression within the 3 months prior to 
initial treatment. Evidence of progression must be documented by deterioration of 
visual acuity (at least 5 letters on a standard eye examination chart), lesion growth 
(an increase in at least 1 disk area), or the appearance of blood associated with the 
lesion.  
 
C.  Nationally Non-Covered Indications 
 
Other uses of OPT with verteporfin to treat AMD not already addressed by the Centers 
for Medicare & Medicaid Services will continue to be non-covered. These include, but 
are not limited to, the following AMD indications: juxtafoveal or extrafoveal CNV 
lesions (lesions outside the fovea), inability to obtain an FA, or atrophic or dry AMD.  
 
D.  Other 
 
The OPT with verteporfin for other ocular indications, such as pathologic myopia or 
presumed ocular histoplasmosis syndrome, continue to be eligible for local coverage 
determinations through individual A/B MAC discretion. 
 
80.4 - Hydrophilic Contact Lenses 
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, 
Implementation: Upon Implementation of ICD-10) 
 
Hydrophilic contact lenses are eyeglasses within the meaning of the exclusion in 
1862(a)(7) of the Social Security Act and are not covered when used in the treatment of 
non-diseased eyes with spherical ametrophia, refractive astigmatism, and/or corneal 
astigmatism.  Payment may be made under the prosthetic device benefit, however, for 
hydrophilic contact lenses when prescribed for an aphakic patient. 
 
A/B MACs are authorized to accept a Food and Drug Administration (FDA) letter of 
approval or other FDA-published material as evidence of FDA approval.  (See 80.1 for 
coverage of a hydrophilic lens as a corneal bandage.) 
 
Cross-references: 
 
The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health 
Services, 100 and 120. 
 
The Medicare Benefit Policy Manual, Chapter 16, General Exclusions from Coverage, 
20 and 90. 
 
80.5 - Scleral Shell 
(Rev. 1, 10-03-03) 
CIM 65.3 
  Scleral shell (or shield) is a catchall term for different types of hard scleral contact lenses.  
A scleral shell fits over the entire exposed surface of the eye as opposed to a corneal 
contact lens which covers only the central non-white area encompassing the pupil and 
iris.  Where an eye has been rendered sightless and shrunken by inflammatory disease, a 
scleral shell may, among other things, obviate the need for surgical enucleation and 
prosthetic implant and act to support the surrounding orbital tissue.  In such a case, the 
device serves essentially as an artificial eye.  In this situation, payment may be made for a 
scleral shell under 1861(s)(8) of the Act. 
 
Scleral shells are occasionally used in combination with artificial tears in the treatment of 
dry eye of diverse etiology.  Tears ordinarily dry at a rapid rate, and are continually 
replaced by the lacrimal gland.  When the lacrimal gland fails, the half-life of artificial 
tears may be greatly prolonged by the use of the scleral contact lens as a protective 
barrier against the drying action of the atmosphere.  Thus, the difficult and sometimes 
hazardous process of frequent installation of artificial tears may be avoided.  The lens 
acts in this instance to substitute, in part, for the functioning of the diseased lacrimal 
gland and would be covered as a prosthetic device in the rare case when it is used in the 
treatment of dry eye. 
 
Cross-references: 
 
The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health 
Services, 120 and 130 
 
The Medicare Benefit Policy Manual, Chapter 1, Inpatient Hospital Services, 40 and 
120.1. 
 
80.6 - Intraocular Photography 
(Rev. 1, 10-03-03) 
CIM 35-39 
 
Intraocular photography is covered when used for the diagnosis of such conditions as 
macular degeneration, retinal neoplasms, choroid disturbances and diabetic retinopathy, 
or to identify glaucoma, multiple sclerosis and other central nervous system 
abnormalities.  Make Medicare payment for the use of this procedure by an 
opthalmologist in these situations when it is reasonable and necessary for the individual 
patient to receive these services. 
 
80.7 - Refractive Keratoplasty 
(Rev. 1, 10-03-03) 
CIM 35-54 
 
Not Covered 
 
Refractive keratoplasty is surgery to reshape the cornea of the eye to correct vision 
problems such as myopia (nearsightedness) and hyperopia (farsightedness).  Refractive  keratoplasty procedures include keratomileusis, in which the front of the cornea is 
removed, frozen, reshaped, and stitched back on the eye to correct either near or 
farsightedness; keratophakia, in which a reshaped donor cornea is inserted in the eye to 
correct farsightedness; and radial keratotomy, in which spoke-like slits are cut in the 
cornea to weaken and flatten the normally curved central portion to correct 
nearsightedness. 
 
The correction of common refractive errors by eyeglasses, contact lenses or other 
prosthetic devices is specifically excluded from coverage.  The use of radial keratotomy 
and/or keratoplasty for the purpose of refractive error compensation is considered a 
substitute or alternative to eye glasses or contact lenses which are specifically excluded 
by 1862 (a)(7) of the Act (except in certain cases in connection with cataract surgery).  
In addition, many in the medical community consider such procedures cosmetic surgery 
which is excluded by 1862 (a)(10) of the Act.  Therefore, radial keratotomy and 
keratoplasty to treat refractive defects are not covered. 
 
80.7.1 - Keratoplasty 
(Rev. 1, 10-03-03) 
 
Keratoplasty that treats specific lesions of the cornea, such as phototherapeutic 
keratectomy that removes scar tissue from the visual field, deals with an abnormality of 
the eye and is not cosmetic surgery.  Such cases may be covered under 1862(a)(1)(A) of 
the Act. 
 
The use of lasers to treat ophthalmic disease constitutes opthalmalogic surgery.  
Coverage is restricted to practitioners who have completed an approved training program 
in ophthalmologic surgery. 
 
80.8 - Endothelial Cell Photography 
(Rev. 1, 10-03-03) 
CIM 50-38 
 
Endothelial cell photography involves the use of a specular microscope to determine the 
endothelial cell count.  It is used by ophthalmologists as a predictor of success of ocular 
surgery or certain other ocular procedures.  Endothelial cell photography is a covered 
procedure under Medicare when reasonable and necessary for patients who meet one or 
more of the following criteria: 
 
  Have slit lamp evidence of endothelial dystrophy (cornea guttata), 
  Have slit lamp evidence of corneal edema (unilateral or bilateral), 
  Are about to undergo a secondary intraocular lens implantation, 
  Have had previous intraocular surgery and require cataract surgery, 
  Are about to undergo a surgical procedure associated with a higher risk to corneal 
endothelium; i.e., phacoemulsification, or refractive surgery (see 80.7 for 
excluded refractive procedures), 
  With evidence of posterior polymorphous dystrophy of the cornea or irido- corneal-endothelium syndrome, or 
  Are about to be fitted with extended wear contact lenses after intraocular surgery. 
 
When a presurgical examination for cataract surgery is performed and the conditions of 
this section are met, if the only visual problem is cataracts, endothelial cell photography 
is covered as part of the presurgical comprehensive eye examination or combination 
brief/intermediate examination provided prior to cataract surgery, and not in addition to 
it.  (See 10.1) 
 
80.9 - Computer Enhanced Perimetry 
(Rev. 1, 10-03-03) 
CIM 50-49 
 
Computer enhanced perimetry involves the use of a micro-computer to measure visual 
sensitivity at preselected locations in the visual field.  It is a covered service when used in 
assessing visual fields in patients with glaucoma or other neuropathologic defects. 
 
80.10 - Phaco-Emulsification Procedure - Cataract Extraction 
(Rev. 1, 10-03-03) 
CIM 35-9 
 
In view of recommendations of authoritative sources in the field of ophthalmology, the 
subject technique is viewed as an accepted procedure for removal of cataracts.  
Accordingly, program reimbursement may be made for necessary services furnished in 
connection with cataract extraction utilizing the phaco-emulsification procedure. 
 
80.11 - Vitrectomy 
(Rev. 48, Issued:  03-17-06; Effective/Implementation Dates:  06-19-06) 
CIM - 35-16 
 
Vitrectomy may be considered reasonable and necessary for the following conditions:  
vitreous loss incident to cataract surgery, vitreous opacities due to vitreous hemorrhage or 
other causes, retinal detachments secondary to vitreous strands, proliferative retinopathy, 
and vitreous retraction.  See chapter 23 of the Medicare Claims Processing Manual for 
how to determine payment for physician vitrectomy services and the Medicare Claims 
Processing Manual, Chapter 14, Ambulatory Surgical Centers, 40, for how to 
determine payment for ASC facility vitrectomy services.  Also, see the Medicare Claims 
Processing Manual, Chapter 23, Fee Schedule Administration and Coding 
Requirements, 20.9, to identify when, for Medicare payment purposes, certain 
vitrectomy codes are included in other codes or when codes for other services include 
vitrectomy codes. 
 
80.12 - Intraocular Lenses (IOLs) 
(Rev. 1, 10-03-03) 
CIM 65-7 
  An intraocular lens, or pseudophakos, is an artificial lens which may be implanted to 
replace the natural lens after cataract surgery.  Intraocular lens implantation services, as 
well as the lens itself, may be covered if reasonable and necessary for the individual. 
Implantation services may include hospital, surgical, and other medical services, 
including preimplantation ultrasound (A-scan) eye measurement of one or both eyes. 
 
Cross-reference: 
 
The Medicare Benefit Policy Manual, Chapter 6,Hospital Services Covered Under Part 
B, 10. 
 
The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health 
Services, 120. 
 
The Medicare Benefit Policy Manual, Chapter 16, General Exclusions from Coverage, 
20 and 90. 
  Transmittals Issued for this Chapter 
 
Rev.#  Issue Date  Subject  Impl. Date  CR 
R12112NCD  06/29/2023  Technical Revisions Only to the  07/31/2023  13220 
National Coverage Determination 
(NCD) Manual, Publication (Pub) 
100-03 
R11892NCD   03/09/2023  Technical Revisions Only to the  04/10/2023  13105 
National Coverage Determination 
(NCD) Manual 
R11875NCD  02/23/2023  National Coverage Determination  03/24/2023  13073 
(NCD) 50.3 - Cochlear 
Implantation Manual Update 
R10985NCD  09/08/2021  Claims Processing Instructions for  10/08/2021  12361 
National Coverage Determination 
20.33 - Transcatheter Edge-to-
Edge Repair [TEER] for Mitral 
Valve Regurgitation 
R10838NCD  06/08/2021  National Coverage Determination  06/22/2021  12254 
(NCD) Removal 
R10837NCD  06/11/2021  National Coverage Determination  07/27/2021  12290 
(NCD) 20.9.1 Ventricular Assist 
Devices (VADs) 
 
R10797NCD  05/20/2021  National Coverage Determination  06/22/2021  12254 
(NCD) Removal- Rescinded and 
replaced by Transmittal 10838 
R10337NCD  08/27/2020  National Coverage Determination  10/05/2020  11755 
(NCD30.3.3): Acupuncture for 
Chronic Low Back Pain (cLBP) 
R10128NCD  05/08/2020  National Coverage Determination  10/05/2020  11755 
(NCD30.3.3): Acupuncture for 
Chronic Low Back Pain (cLBP)- 
Rescinded and replaced by 
Transmittal 10337 
R10179NCD  06/10/2020  NCD (20.32) Transcatheter Aortic  06/12/2020  11660 
Valve Replacement (TAVR) 
R217NCD  03/13/2020  NCD (20.32) Transcatheter Aortic  06/12/2020  11660 
Valve Replacement (TAVR)- 
Rescinded and replaced by 
Transmittal 10179 
R213NCD  02/15/2019  National Coverage Determination  03/26/2019  10865 
(NCD) 20.4 Implantable Cardiac 
Defibrillators (ICDs) 
R209NCD  11/21/2018  National Coverage Determination  02/26/2019  10865 
(NCD) 20.4 Implantable Cardiac  Rev.#  Issue Date  Subject  Impl. Date  CR 
Defibrillators (ICDs)  Rescinded 
and replaced by Transmittal 211 
R212NCD  01/18/2019  Update to Pub. 100-03 to Provide  02/19/2019  11118 
Language-Only Changes for the 
New Medicare Card Project 
R207NCD  05/11/2018  Supervised Exercise Therapy  07/02/2018  10295 
(SET) for Symptomatic Peripheral 
Artery Disease (PAD) 
R206NCD  04/03/2018  Supervised Exercise Therapy  07/02/2018  10295 
(SET) for Symptomatic Peripheral 
Artery Disease (PAD)- Rescinded 
and replaced by Transmittal 207 
R204NCD  02/02/2018  Supervised Exercise Therapy  04/03/2018  10295 
(SET) for Symptomatic Peripheral 
Artery Disease (PAD) 
R203NCD  11/17/2017  Hyperbaric Oxygen (HBO)  12/18/2017  10220 
Therapy (Section C, Topical 
Application of Oxygen) 
R201NCD  08/28/2017  National Coverage Determination  08/29/2017  10117 
(NCD20.8.4): Leadless 
Pacemakers 
 
R192NCD  05/06/2016  Percutaneous Left Atrial  10/03/2016  9638 
Appendage Closure (LAAC) 
R187NCD  12/102015  National Coverage Determination  01/13/2016  9078 
(NCD) for Single Chamber and 
Dual Chamber Permanent Cardiac 
Pacemakers - This CR rescinds 
and fully replaces CR 8525  
R186NCD  10/26/2015  National Coverage Determination  07/06/2015  9078 
(NCD) for Single Chamber and 
Dual Chamber Permanent Cardiac 
Pacemakers - This CR rescinds 
and fully replaces CR 8525  
Rescinded and replaced by 
Transmittal 187 
R184NCD  08/21/2015  Update to Pub. 100-03, National  09/21/2015  9281 
Coverage Determination Manual, 
Chapter 1, Part 1, Section 50.1 
Speech Generating Device 
R182NCD  05/22/2015  NCD20.30 Microvolt T-wave  06/23/2015  9162 
Alternans (MTWA) 
R180NCD  03/06/2015  Removal of Multiple National  04/06/2015  9095 
Coverage Determinations Using 
Expedited Process  Rev.#  Issue Date  Subject  Impl. Date  CR 
R179NCD  02/20/2015  National Coverage Determination  07/06/2015  9078 
(NCD) for Single Chamber and 
Dual Chamber Permanent Cardiac 
Pacemakers - This CR rescinds 
and fully replaces CR 8525  
Rescinded and replaced by 
Transmittal 186 
R178NCD  12/05/2014  Transcatheter Mitral Valve Repair  04/06/2015  9002 
(TMVR)-National Coverage 
Determination (NCD) 
R175NCD  10/03/2014  Intensive Cardiac Rehabilitation  11/04/2014  8894 
Program - Benson-Henry Institute 
Cardiac Wellness Program 
R173NCD  09/04/2014  Pub 100-03, Chapter 1, Language- Upon  8506 
only Update  Implement
ation of 
ICD-10 
R172NCD  08/29/2014  Ventricular Assist Devices for  09/30/2014  8803 
Bridge-to-Transplant and 
Destination Therapy 
R170NCD  07/10/2014  National Coverage Determination  To Be  8525 
(NCD) for Single Chamber and  Determined 
Dual Chamber Permanent Cardiac 
Pacemakers  Fully rescinded and 
replaced by CR 9078 
R161NCD  02/06/2014  National Coverage Determination  07/07/2014  8525 
(NCD) for Single Chamber and 
Dual Chamber Permanent Cardiac 
Pacemakers  Rescinded and 
replaced by Transmittal 170 
R159NCD  02/05/2014  Pub 100-03, Chapter 1, Language- 10/01/2014  8506 
only Update  Rescinded and 
replaced by Transmittal 173 
R158NCD  12/23/2013  Bariatric Surgery for Treatment of  12/17/2013  8484 
Co-Morbid Conditions Related to 
Morbid Obesity 
R157NCD  11/15/2013  Bariatric Surgery for Treatment of  12/17/2013  8484 
Co-Morbid Conditions Related to 
Morbid Obesity  Rescinded and 
replaced by Transmittal 158 
R155NCD  06/14/2013  Ocular Photodynamic Therapy  07/16/2013  8292 
(OPT) with Verteporfin for 
Macular Degeneration 
R151NCD  02/08/2013  Change of Address for  03/11/2013  8199 
Percutaneous Transluminal  Rev.#  Issue Date  Subject  Impl. Date  CR 
Angioplasty (PTA) of the Carotid 
Artery Concurrent with Stenting 
Facility Approval and 
Recertification Letter Submission 
R149NCD  11/30/2012  Transcutaneous Electrical Nerve  01/07/2013  7836 
Stimulation (TENS) for Chronic 
Low Back Pain (CLBP) 
R147NCD  09/24/2012  National Coverage Determination  01/07/2013  7897 
(NCD) for Transcatheter Aortic 
Valve Replacement 
R145NCD  08/03/2012  National Coverage Determination  01/07/2013  7897 
(NCD) for Transcatheter Aortic 
Valve Replacement  Rescinded 
and replaced by Transmittal 147 
R144NCD  08/03/2012  Transcutaneous Electrical Nerve  01/07/2013  7836 
Stimulation (TENS) for Chronic 
Low Back Pain (CLBP)  
Rescinded and replaced by 
Transmittal 149 
R129NCD  12/08/2010  Ventricular Assist Devices (VAD)  01/06/2011  7220 
as Destination Therapy 
R128NCD  11/19/2010  Ventricular Assist Devices (VAD)  01/06/2011  7220 
as Destination Therapy - 
Rescinded and replaced by 
Transmittal 129 
R125NCD  09/24/2010  Intensive Cardiac Rehabilitation  10/25/2010  7113 
(ICR) Programs-Dr. Ornishs 
Program for Reversing Heart 
Disease and the Pritikin Program 
R117NCD  03/09/2010  Outpatient Intravenous Insulin  04/05/2010  6775 
Treatment (Therapy) 
R116NCD  03/05/2010  Repeal of Section 20.10, Cardiac  04/05/2010  6855 
Rehabilitation (CR) Program 
R115NCD  03/05/2010  Percutaneous Transluminal  04/05/2010  6839 
Angioplasty (PTA) of the Carotid 
Artery Concurrent With Stenting 
R114NCD  02/22/2010  Outpatient Intravenous Insulin  03/08/2010  6775 
Treatment (Therapy)  Rescinded 
and replaced by Transmittal 117 
R112NCD  02/05/2010  Outpatient Intravenous Insulin  03/08/2010  6775 
Treatment (Therapy) - Rescinded 
and replaced by Transmittal 114 
R98NCD  12/24/2008  Percutaneous Transluminal  01/26/2009  6301 
Angioplasty of the Carotid Artery 
Concurrent With Stenting  Rev.#  Issue Date  Subject  Impl. Date  CR 
R95NCD  09/10/2008  Artificial Hearts  12/01/2008  6185 
R93NCD  08/29/2008  Artificial Hearts - Replaced by  10/06/2008  6185 
Transmittal 95 
R88NCD  07/25/2008  Microvolt T-Wave Alterans  08/25/2008  6154 
(MTWA) 
R87NCD  07/11/2008  Percutaneous Transluminal  08/11/2008  6137 
Angioplasty (PTA) With Stenting 
R81NCD  04/04/2008  Percutaneous Transluminal  05/05/2008  5984 
Angioplasty (PTA) 
R77NCD  09/12/2007  Percutaneous Transluminal  07/30/2007  5660 
Angioplasty (PTA) 
R71NCD  06/29/2007  Percutaneous Transluminal  07/30/2007  5660 
Angioplasty (PTA) - Replaced by 
Transmittal 77 
R68NCD  04/13/2007  Ventricular Assist Devices  05/14/2007  5516 
(VADs) 
R64NCD  01/05/2007  Intracranial Percutaneous  02/05/2007  5432 
Transluminal Angioplasty (PTA) 
with Stenting 
R63NCD  12/15/2006  Cardiac Output Monitoring by  01/16/2007  5414 
Thoracic Electrical Bioimpedance 
(TEB) 
R54NCD  04/28/2006  Bariatric Surgery for Treatment of  05/30/2006  5013 
Morbid Obesity 
R53NCD  04/21/2006  Clarification on Billing  N/A  5022 
Requirements for Percutaneous 
Transluminal Angioplasty (PTA) 
Concurrent with the Placement of 
an Investigational or FDA-
Approved Carotid Stent 
R52NCD  04/21/2006  Cardiac Rehabilitation Programs  06/21/2006  4401 
R50NCD  03/31/2006  External Counterpulsation  04/03/2006  4350 
Therapy 
R49NCD  03/24/2006  Microvolt T-Wave Alternans  04/03/2006  4351 
(MTWA) Diagnostic Testing 
R48NCD  03/17/2006  Technical Corrections to the NCD  06/19/2006  4278 
Manual 
R46NCD  01/27/2006  Cardiac Catheterization Performed  02/27/2006  4280 
in Other Than a Hospital Setting 
R42NCD  07/01/2005  Cochlear Implantation  07/25/2005  3796 
R39NCD  06/24/2005  Cochlear Implantation - Replaced  07/05/2005  3796 
by Revision 42 
R33NCD  04/22/2005  Percutaneous Transluminal  07/05/2005  3811 
Angioplasty (PTA  Rev.#  Issue Date  Subject  Impl. Date  CR 
R29NCD  03/04/2005  Implantable Automatic  04/04/2005  3604 
Defibrillators 
R26NCD  12/10/2004  Electrocardiographic Services  10/10/2004  3590 
R25NCD  10/15/2004  Percutaneous Transluminal  10/12/2004  3489 
Angioplasty (PTA) 
R23NCD  10/01/2004  Treatment of Obesity  10/01/2004  3502 
R16NCD  06/25/2004  Cardiac Pacemaker  04/30/2004  3369 
R12NCD  04/30/2004  Cardiac Pacemakers - Replaced by  04/30/2004  3290 
Revision 16 
R11NCD  04/16/2004  Noncoverage of Acupuncture for  04/06/2004  3250 
Fibromyalgia/Osteoarthritis 
R10NCD  04/06/2004  Re-release of NCD Manual  N/A  N/A 
R09NCD  04/01/2004  NCD - Ocular Photodynamic  04/01/2004  3191 
Therapy (OPT) With Verteporfin 
for Age-Related Macular 
Degeneration (AMD) 
R06NCD  01/23/2004  Cardiac Output Monitoring by  02/23/2004  2689 
Thoracic Electrical Bioimpedance 
R02NCD  10/17/2003  Artificial hearts and Related  10/01/2003  2958 
Devices 
R01NCD  10/01/2003  Initial Release of Manual  N/A  N/A 
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