100-03 Medicare National Coverage Determinations (NCD) Manual: Chapter 1 - Coverage Determinations, Part 1 Sections 10 - 80.12

Medicare National Coverage Determinations
Manual
Chapter 1, Part 1 (Sections 10 – 80.12)
Coverage Determinations
Table of Contents
(Rev. 13800; Issued: 05-28-26)
(Rev. 13801; Issued: 05-28-26)
(Rev. 13802; Issued: 05-28-26)
(Rev. 13806; Issued: 05-28-26)
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)
20.37 – Transcatheter Tricuspid Valve Replacement (TTVR)
20.38- Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER)
20.39 Cardiac Contractility Modulation (CCM) for Heart Failure (HF)
20.40 – Renal Denervation for Uncontrolled Hypertension
30 - Complementary 20.39and 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 Meniere’s Disease
50.8 - Ultrasonic Surgery
60 - Emergency Medicine

70 - Evaluation and Management of Patients - Office/hospital/home
70.1 - Consultations With a Beneficiary’s Family and Associates
70.2 - Consultation Services Rendered by a Podiatrist in a Skilled Nursing
Facility
70.3 - Physician’s Office Within an Institution - Coverage of Services and
Supplies Incident to a Physician’s 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 physician’s 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 patient’s physical
disability, and the use of mechanical devices, and/or activities to relieve pain or modify a
patient’s reaction to it (e.g., nerve stimulator, hydrotherapy, massage, ice, systemic
muscle relaxation training, and diversional activities).
The nurse’s responsibility in such pain rehabilitation programs is to observe and assess,
on a continuing basis, a patient’s 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 patient’s 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 patient’s 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 patient’s 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 patient’s 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 patient’s 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 patient’s 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. 12571; Issued: 04-11-24; Effective: 10-11-23; Implementation: 05-13-24)
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.
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
Effective October 11, 2023, CMS covers PTA of the carotid artery concurrent with
stenting with the placement of an FDA-approved carotid stent with an FDA-approved or
cleared embolic protection device, for Medicare beneficiaries under the following
conditions:
A. Patients with symptomatic carotid artery stenosis ≥50%; and,

B. Patients with asymptomatic carotid artery stenosis ≥70%.
For both A and B above:
1. Neurological assessment by a neurologist or NIH stroke scale (NIHSS) certified
health professional before and after CAS must be performed.
2. First-line evaluation of carotid artery stenosis must use duplex ultrasound.
3. Computed tomography angiography or magnetic resonance angiography, if not
contraindicated, must be used to confirm the degree of stenosis and provide
additional information about the aortic arch, and extra- and intra-cranial
circulation.
4. Intra-arterial digital subtraction (catheter) angiography may be used only when
there is significant
discrepancy between non-invasive imaging results, or in lieu of computed
tomography angiography or
magnetic resonance angiography if these are contraindicated.
Prior to furnishing CAS, the practitioner must engage in a formal shared decision-making
interaction with the beneficiary. The shared decision-making interaction must include:
• 	Discussion of all treatment options including carotid endarterectomy (CEA), CAS
(which includes transcarotid artery revascularization (TCAR), and optimal
medical therapy (OMT)).
• 	Explanation of risks and benefits for each option specific to the beneficiary’s
clinical situation.
• 	Integration of clinical guidelines (e.g., patient comorbidities and concomitant
treatments).
• 	Discussion and incorporation of beneficiary’s personal preferences and priorities
in choosing a treatment plan.
Facilities must establish and maintain institutional and physician standards to support a
dedicated carotid stent program. These standards must at least include and ensure the
following:
• 	Facilities have a clearly delineated program for granting carotid stent privileges
and for monitoring patient outcomes for individual physicians and the program as
a whole.
• 	The oversight committee for this program shall be empowered to identify the
minimum case volume for a physician 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 specialty societies and widely-
used, published professional society guidelines to determine appropriate physician
qualifications.
• 	Facilities have appropriately trained staff capable of fulfilling roles and
responsibilities as delineated under the dedicated carotid stent program.

• 	Facilities have appropriate supporting personnel and equipment for imaging,
emergency management, advanced physiologic monitoring, and other ancillary
care.
• 	Facilities must ensure continuous quality improvement by assessing procedural
outcomes and making necessary programmatic adjustments to assure patient
safety.
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
In addition to the national coverage described above, Medicare Administrative
Contractors (MACs) may make reasonable and necessary determinations under section
1862(a)(1)(A) of the Social Security Act for any other beneficiary seeking coverage for
PTA of the carotid artery concurrent with stenting.
Coverage of PTA with stenting not specifically addressed or discussed in this NCD is at
the discretion of the MACs.
(This NCD last reviewed October 2023)
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 patient’s pacemaker should be monitored is the
responsibility of the patient’s 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 patient’s physician, such as
a commercial monitoring service or hospital outpatient department, the physician’s
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 patient’s 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 patient’s overall condition, a reprogramming
of the patient’s pacemaker, the development of better information on the pacemaker’s
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 patient’s 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 patient’s 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 pacemaker’s
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 study’s 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 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: 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:
o 	Are on optimal medical management (OMM), based on current heart
failure practice guidelines for at least 45 out of the last 60 days and are
failing to respond; or
o 	Have advanced heart failure for at least 14 days and are dependent on an
intra‐aortic 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 heart’s 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 patient’s 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 physician’s 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 physician’s 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 Holter™ 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.
o 	Implantable (or Insertable Loop) Recorder (ILR)
Another type of pre-symptom MLR, it is implanted subcutaneously in a patient’s 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 Holter™
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 patient’s 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 physician’s 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 patient’s 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., Holter™ Monitor)
20.16 - Cardiac Output Monitoring By Thoracic Electrical
Bioimpedance (TEB) – Various Effective Dates Below
(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10,
Implementation: Upon Implementation of ICD-10)
A. 	General
Thoracic electrical bioimpedance (TEB) devices, a form of plethysmography, monitor
cardiac output by non-invasively measuring hemodynamic parameters, including: stroke
volume, systemic vascular resistance, and thoracic fluid status. Under a previous
coverage determination, effective for services performed on and after July 1, 1999, use of
TEB was covered for the “noninvasive diagnosis or monitoring of hemodynamics in
patients with suspected or known cardiovascular disease.” In reconsidering this policy,
the Centers for Medicare & Medicaid Services (CMS) concluded that this use was neither

sufficiently defined nor supported by available clinical literature to offer the guidance
necessary for practitioners to determine when TEB would be covered for patient
management. Therefore, CMS revised its coverage policy language in response to a
request for reconsideration to offer more explicit guidance and clarity for coverage of
TEB based on a complete and updated literature review.
B. 	Nationally Covered Indications
Effective for services performed on and after January 23, 2004, TEB is covered for the
following uses:
1. 	Differentiation of cardiogenic from pulmonary causes of acute dyspnea when medical
history, physical examination, and standard assessment tools provide insufficient
information, and the treating physician has determined that TEB hemodynamic data are
necessary for appropriate management of the patient.
2. 	Optimization of atrioventricular (A/V) interval for patients with A/V sequential
cardiac 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 one’s 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. 10073, Issued: 05-01-20, Effective: 07-02-19 Implementation: 06- 16-20, 10-05-
20)
A. General
Ambulatory Blood Pressure Monitoring (ABPM) is a diagnostic test that allows for the
identification of various types of high blood pressure (BP). ABPM devices are small
portable machines that are connected to a blood pressure cuff worn by patients that record
blood pressure at regular periods over 24 to 48 hours while the patient goes about their
normal activities, including sleep. The recording is interpreted by a physician or non-
physician practitioner, and appropriate action is taken based on the findings. Diagnosis
and treatment of high BP is important for the management of various conditions
including cardiovascular disease and kidney disease.
B. Nationally Covered Indications
For dates of service on and after July 2, 2019, the Centers for Medicare & Medicaid
Services (CMS) believes that the evidence is sufficient to determine that ABPM is
reasonable and necessary for the diagnosis of hypertension in Medicare beneficiaries
under the following circumstances:

1. 	For beneficiaries with suspected white coat hypertension, which is defined as
average office BP of systolic BP >130 mm Hg but <160 mm Hg, or diastolic BP
>80 mm Hg but <100 mm Hg on two separate clinic/office visits with at least two
separate measurements made at each visit, and with at least two BP measurements
taken outside the office which are <130/80 mm Hg.
2. 	For beneficiaries with suspected masked hypertension, which is defined as
average office BP between 120 mm Hg and 129 mm Hg for systolic BP, or
between 75 mm HG and 79 mm Hg for diastolic BP on two separate clinic/office
visits with at least two separate measurements made at each visit, and at least two
BP measurements taken outside the office which are ≥130/80 mm Hg.
ABPM devices must be:
• 	capable of producing standardized plots of BP measurements for 24 hours with
daytime and night-time windows and normal BP bands demarcated; and,
• 	provided to patients with oral and written instructions and a test run in the
physician’s office must be performed; and,
• 	interpreted by the treating physician or treating non-physician practitioner.
For eligible patients, ABPM is covered once per year.
C. Nationally Non-Covered Indications
N/A
D. Other
Coverage of other indications for ABPM not indicated above are at the discretion of the
Medicare Administrative Contractors.
(Last reviewed July 2019.)
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 patient’s
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 patient’s 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 (Pick’s disease, Alzheimer’s disease,
Korsakoff’s 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 physician’s 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 people’s blood pressures were higher during visits to my
office than at other times and wondered whether stress wasn’t causing that rise. Stress
wasn’t 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 patient’s
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 study’s 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 patient’s 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 patient’s 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 patient’s 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 patient’s 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 study’s 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 device’s FDA-
approved indication and meet all of the conditions specified below:
The patient must have:
o 	A CHADS2 score ≥ 2 (Congestive heart failure, Hypertension, Age >75,
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)
o 	A formal shared decision making interaction with an independent non-
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.
o 	A suitability for short-term warfarin but deemed unable to take long-term oral
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
registry’s 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 investigator’s 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 study’s 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 physician’s 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.)
20.37 – Transcatheter Tricuspid Valve Replacement (TTVR)
(Rev. 13800; Issued:05-28-26; Effective: 03-19-25; Implementation: 01-05-26)
A. 	General
Transcatheter Tricuspid Valve Replacement (TTVR) is used in the treatment of tricuspid
regurgitation.
B. 	Nationally Covered Indications
The Centers for Medicare & Medicaid Services (CMS) covers transcatheter tricuspid
valve replacement (TTVR) for the treatment of symptomatic tricuspid regurgitation (TR)
under Coverage with Evidence Development (CED) according to the provisions below:
Coverage Criteria:

TTVR is covered when furnished according to a Food and Drug Administration (FDA)
market-authorized indication and all the following conditions are met:
1. 	Patient Criteria
Despite optimal medical therapy (OMT), patients must have symptomatic TR with
tricuspid valve replacement being considered as appropriate by a heart team.
2. 	Physician Criteria
The patient (preoperatively and postoperatively) is under the care of a heart team, which
includes, at minimum, the following:
a) 	Cardiac surgeon;
b) 	Interventional cardiologist;
c) 	Cardiologist with training and experience in heart failure management;
d) 	Electrophysiologist;
e) 	Multi-modality imaging specialists; and
f) 	Interventional echocardiographer
All of the specialists listed above must have experience in the care and treatment of TR.
3. 	CED Study Criteria
The TTVR items and services are furnished in the context of a CMS-approved CED study.
CMS-approved CED study protocols must: include only those patients who meet the
criteria in section B.1; furnish items and services only through practitioners who meet
the criteria in section B.2; and include all of the following:
a) 	Primary outcomes of all-cause mortality, hospitalizations, or a composite of these,
through a minimum of 24 months. For composite outcome measures, physiologic, patient-
reported, and other relevant health outcomes should be co-directional (i.e., all outcomes
comprising the composite outcome should demonstrate movement in the same direction).
Each component of a composite outcome must be individually reported.
b) An active comparator.
c) A care management plan that includes the experience and role of each member of the
heart team described in section B.2.
d) Design sufficient for subgroup analyses by:
• Age;
• Sex;
• Race and ethnicity;
• Practitioner and facility level variables that predict the primary outcomes of the study;

• Left ventricular ejection fraction (by guideline-defined subgroups);
• Previous tricuspid surgery or intervention;
• Severe aortic or mitral stenosis or regurgitation;
• Patients with chronic kidney disease;
• Patients with indwelling cardiac implantable electronic devices;
e) CMS-approved CED studies must adhere to the following scientific standards (criteria
1-17 below) that have been identified by the Agency for Healthcare Research and Quality
(AHRQ) as set forth in Section VI. of CMS’ Coverage with Evidence Development
Guidance Document, published August 7, 2024. https://www.cms.gov/medicare-
coverage-database/view/medicare-coverage-document.aspx?mcdid=38
1. Sponsor/Investigator: The study is conducted by sponsors/investigators with the
resources and skills to complete it successfully.
2. Milestones: A written plan is in place that describes a detailed schedule for completion
of key study milestones, including study initiation, enrollment progress, interim results
reporting, and results reporting, to ensure timely completion of the CED process.
3. Study Protocol: The CED study is registered with ClinicalTrials.gov and a complete
final protocol, including the statistical analysis plan, is delivered to CMS prior to study
initiation. The published protocol includes sufficient detail to allow a judgment of
whether the study is fit-for-purpose and whether reasonable efforts will be taken to
minimize the risk of bias. Any changes to approved study protocols should be explained
and publicly reported.
4. Study Context: The rationale for the study is supported by scientific evidence and study
results are expected to fill the specified CMS-identified evidence deficiency and provide
evidence sufficient to assess health outcomes.
5. Study Design: The study design is selected to safely and efficiently generate valid
evidence of health outcomes. The sponsors/investigators minimize the impact of
confounding and biases on inferences through rigorous design and appropriate statistical
techniques. If a contemporaneous comparison group is not included, this choice should
be justified, and the sponsors/investigators discuss in detail how the design contributes
useful information on issues such as durability or adverse event frequency that are not
clearly answered in comparative studies.
6. Study Population: The study population reflects the demographic and clinical diversity
among the Medicare beneficiaries who are the intended population of the intervention,
particularly when there is good clinical or scientific reason to expect that the results
observed in premarket studies might not be observed in older adults or subpopulations
identified by other clinical or demographic factors. At a minimum, this includes attention
to the intended population’s racial and ethnic backgrounds, sex, age, disabilities,
important comorbidities, and, dependent on data availability, relevant health related

social needs. For instance, more than half of Medicare beneficiaries are women so study
designs should, as appropriate, consider the prevalence in women of the condition being
studied as well as in the clinical trial and subsequent data reporting and analyses.
7. Subgroup Analyses: The study protocol explicitly discusses beneficiary subpopulations
affected by the item or service under investigation, particularly traditionally
underrepresented groups in clinical studies, how the inclusion and exclusion
requirements effect enrollment of these populations, and a plan for the retention and
reporting of said populations in the trial. In the protocol, the sponsors/investigators
describe plans for analyzing demographic subpopulations as well as clinically relevant
subgroups as identified in existing evidence. Description of plans for exploratory
analyses, as relevant subgroups emerge, are also included.
8. Care Setting: When feasible and appropriate for answering the CED question, data for
the study should come from beneficiaries in their expected sites of care.
9. Health Outcomes: The primary health outcome(s) for the study are those important to
patients and their caregivers and that are clinically meaningful. A validated surrogate
outcome that reliably predicts these outcomes may be appropriate for some questions.
Generally, when study sponsors propose using surrogate endpoints to measure outcomes,
they should cite validation studies published in peer-reviewed journals to provide a
rationale for assuming these endpoints predict the health outcomes of interest. The cited
validation studies should be longitudinal and demonstrate a statistical association
between the surrogate endpoint and the health outcomes it is thought to predict.
10. Objective Success Criteria: In consultation with CMS and AHRQ,
sponsors/investigators establish an evidentiary threshold for the primary health
outcome(s) so as to demonstrate clinically meaningful differences with sufficient
precision.
11. Data Quality: The data are generated or selected with attention to provenance, bias,
completeness, accuracy, sufficiency of duration of observation to demonstrate durability
of health outcomes, and sufficiency of sample size as required by the question.
12. Construct Validity: Sponsors/investigators provide information about the validity of
drawing warranted conclusions about the study population, primary exposure(s)
(intervention, control), health outcome measures, and core covariates when using either
primary data collected for the study about individuals or proxies of the variables of
interest, or existing (secondary) data about individuals or proxies of the variables of
interest.
13. Sensitivity Analyses: Sponsors/investigators will demonstrate robustness of results by
conducting pre-specified sensitivity testing using alternative variable or model
specifications as appropriate.

14. Reporting: Final results are provided to CMS and submitted for publication or
reported in a publicly accessible manner within 12 months of the study’s primary
completion date. Wherever possible, the study is submitted for peer review with the goal
of publication using a reporting guideline appropriate for the study design and structured
to enable replication. If peer-reviewed publication is not possible, results may also be
published in an online 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 incomplete results).
15. Sharing: The sponsors/investigators commit to making study data publicly available
by sharing data, methods, analytic code, and analytical output with CMS or with a CMS-
approved third party. The study should comply with all applicable laws regarding subject
privacy, including 45 CFR § 164.514 within the regulations promulgated under the
Health Insurance Portability and Accountability Act of 1996 (HIPAA) and 42 CFR, Part
2: Confidentiality of Substance Use Disorder Patient Records.
16. Governance: The protocol describes the information governance and data security
provisions that have been established to satisfy Federal security regulations issued
pursuant to HIPAA and codified at 45 CFR Parts 160 and 164 (Subparts A & C), United
States Department of Health and Human Services (HHS) regulations at 42 CFR, Part 2:
Confidentiality of Substance Use Disorder Patient and HHS regulations at 45 CFR Part
46, regarding informed consent for clinical study involving human subjects. In addition
to the requirements under 42 CFR and 45 CFR, studies that are subject to FDA
regulation must also comply with regulations at 21 CFR Parts 50 and 56 regarding the
protection of human subjects and institutional review boards, respectively.
17. Legal: The study is not designed to exclusively test toxicity or disease
pathophysiology in healthy individuals, although it is acceptable for a study to test a
reduction in toxicity of a product relative to standard of care or an appropriate
comparator. For studies that involve researching the safety and effectiveness of new
drugs and biological products aimed at treating life-threatening or severely debilitating
diseases, refer to additional requirements set forth in 21 CFR § 312.81(a).
Consistent with section 1142 of the Social Security Act, AHRQ supports clinical research
studies that CMS determines meet all the criteria and standards identified above.
C. 	Other Uses of TTVR
1. 	Transcatheter tricuspid valve replacement (TTVR) is not covered for patients
outside of a CMS-approved study.
2. 	Nothing in this NCD would preclude coverage of TTVR through NCD 310.1
(Clinical Trial Policy) or through the Investigational Device Exemption (IDE)
Policy.
(This NCD last reviewed March 2025.)

20.38- Transcatheter Edge-to-Edge Repair for Tricuspid Valve
Regurgitation (T-TEER)
(Rev. 13801; Issued: 05-28-26; Effective: 07-02-25; Implementation: 01-05-26)
A. 	General
Transcatheter Edge-to-Edge Repair for Tricuspid Valve Regurgitation (T-TEER) is used
in the treatment of tricuspid regurgitation.
B. 	Nationally Covered Indications
The Centers for Medicare & Medicaid Services (CMS) covers tricuspid transcatheter
edge-to-edge repair (T-TEER) for the treatment of symptomatic tricuspid regurgitation
(TR) under Coverage with Evidence Development (CED) according to the provisions
below:
Coverage Criteria:
T-TEER is covered when furnished according to a Food and Drug Administration (FDA)
market-authorized indication and all the following conditions are met:
4. 	Patient Criteria
Despite optimal medical therapy (OMT), patients must have symptomatic TR with
tricuspid valve repair being considered as appropriate by a heart team.
5. 	Physician Criteria
The patient (preoperatively and postoperatively) is under the care of a heart team, which
includes, at minimum, the following:
g) 	Cardiac surgeon;
h) 	Interventional cardiologist;
i) 	Cardiologist with training and experience in heart failure management; and
j) 	Interventional echocardiographer
All the specialists listed above must have experience in the care and treatment of TR.
6. 	CED Study Criteria
The T-TEER items and services are furnished in the context of a CMS-approved CED
study. CMS-approved CED study protocols must: include only those patients who meet
the criteria in section B.1; furnish items and services only through practitioners who
meet the criteria in section B.2; and include all of the following:

a) 	Primary outcomes of all-cause mortality, hospitalizations, or a composite of these,
through a minimum of 24 months. For composite outcome measures, physiologic, patient-
reported, and other relevant health outcomes should be co-directional (i.e., all outcomes
comprising the composite outcome should demonstrate movement in the same direction).
Each component of a composite outcome must be individually reported.
b) An active comparator.
c) A care management plan that includes the experience and role of each member of the
heart team described in section B.2.
d) Design sufficient for subgroup analyses by:
• Practitioner and facility level variables that predict the primary outcomes of the study;
• Clinically important patient demographic factors;
• Left ventricular ejection fraction (by guideline-defined subgroups);
• Previous tricuspid surgery or intervention;
• Severe aortic or mitral stenosis or regurgitation;
• Patients with chronic kidney disease;
• Patients with indwelling cardiac implantable electronic devices;
• Patients with greater than mild right ventricular dysfunction;
• Patients with hepatic dysfunction; and
• Grade of post-repair residual TR.
e) CMS-approved CED studies must adhere to the following scientific standards (criteria
1-17 below) that have been identified by the Agency for Healthcare Research and Quality
(AHRQ) as set forth in Section VI. of CMS’ Coverage with Evidence Development
Guidance Document, published August 7, 2024. https://www.cms.gov/medicare-
coverage-database/view/medicare-coverage-document.aspx?mcdid=38
1. Sponsor/Investigator: The study is conducted by sponsors/investigators with the
resources and skills to complete it successfully.
2. Milestones: A written plan is in place that describes a detailed schedule for completion
of key study milestones, including study initiation, enrollment progress, interim results
reporting, and results reporting, to ensure timely completion of the CED process.
3. Study Protocol: The CED study is registered with ClinicalTrials.gov and a complete
final protocol, including the statistical analysis plan, is delivered to CMS prior to study
initiation. The published protocol includes sufficient detail to allow a judgment of
whether the study is fit-for-purpose and whether reasonable efforts will be taken to
minimize the risk of bias. Any changes to approved study protocols should be explained
and publicly reported.

4. Study Context: The rationale for the study is supported by scientific evidence and study
results are expected to fill the specified CMS-identified evidence deficiency and provide
evidence sufficient to assess health outcomes.
5. Study Design: The study design is selected to safely and efficiently generate valid
evidence of health outcomes. The sponsors/investigators minimize the impact of
confounding and biases on inferences through rigorous design and appropriate statistical
techniques. If a contemporaneous comparison group is not included, this choice should
be justified, and the sponsors/investigators discuss in detail how the design contributes
useful information on issues such as durability or adverse event frequency that are not
clearly answered in comparative studies.
6. Study Population: The study population reflects the demographic and clinical diversity
among the Medicare beneficiaries who are the intended population of the intervention,
particularly when there is good clinical or scientific reason to expect that the results
observed in premarket studies might not be observed in older adults or subpopulations
identified by other clinical or demographic factors.
7. Subgroup Analyses: The study protocol explicitly discusses beneficiary subpopulations
affected by the item or service under investigation, particularly traditionally
underrepresented groups in clinical studies, how the inclusion and exclusion
requirements effect enrollment of these populations, and a plan for the retention and
reporting of said populations in the trial. In the protocol, the sponsors/investigators
describe plans for analyzing demographic subpopulations as well as clinically relevant
subgroups as identified in existing evidence. Description of plans for exploratory
analyses, as relevant subgroups emerge, are also included.
8. Care Setting: When feasible and appropriate for answering the CED question, data for
the study should come from beneficiaries in their expected sites of care.
9. Health Outcomes: The primary health outcome(s) for the study are those important to
patients and their caregivers and that are clinically meaningful. A validated surrogate
outcome that reliably predicts these outcomes may be appropriate for some questions.
Generally, when study sponsors propose using surrogate endpoints to measure outcomes,
they should cite validation studies published in peer-reviewed journals to provide a
rationale for assuming these endpoints predict the health outcomes of interest. The cited
validation studies should be longitudinal and demonstrate a statistical association
between the surrogate endpoint and the health outcomes it is thought to predict.
10. Objective Success Criteria: In consultation with CMS and AHRQ,
sponsors/investigators establish an evidentiary threshold for the primary health
outcome(s) so as to demonstrate clinically meaningful differences with sufficient
precision.
11. Data Quality: The data are generated or selected with attention to provenance, bias,
completeness, accuracy, sufficiency of duration of observation to demonstrate durability
of health outcomes, and sufficiency of sample size as required by the question.

12. Construct Validity: Sponsors/investigators provide information about the validity of
drawing warranted conclusions about the study population, primary exposure(s)
(intervention, control), health outcome measures, and core covariates when using either
primary data collected for the study about individuals or proxies of the variables of
interest, or existing (secondary) data about individuals or proxies of the variables of
interest.
13. Sensitivity Analyses: Sponsors/investigators will demonstrate robustness of results by
conducting pre-specified sensitivity testing using alternative variable or model
specifications as appropriate.
14. Reporting: Final results are provided to CMS and submitted for publication or
reported in a publicly accessible manner within 12 months of the study’s primary
completion date. Wherever possible, the study is submitted for peer review with the goal
of publication using a reporting guideline appropriate for the study design and structured
to enable replication. If peer-reviewed publication is not possible, results may also be
published in an online 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 incomplete results).
15. Sharing: The sponsors/investigators commit to making study data publicly available
by sharing data, methods, analytic code, and analytical output with CMS or with a CMS-
approved third party. The study should comply with all applicable laws regarding subject
privacy, including 45 CFR § 164.514 within the regulations promulgated under the
Health Insurance Portability and Accountability Act of 1996 (HIPAA) and 42 CFR, Part
2: Confidentiality of Substance Use Disorder Patient Records.
16. Governance: The protocol describes the information governance and data security
provisions that have been established to satisfy Federal security regulations issued
pursuant to HIPAA and codified at 45 CFR Parts 160 and 164 (Subparts A & C), United
States Department of Health and Human Services (HHS) regulations at 42 CFR, Part 2:
Confidentiality of Substance Use Disorder Patient and HHS regulations at 45 CFR Part
46, regarding informed consent for clinical study involving human subjects. In addition
to the requirements under 42 CFR and 45 CFR, studies that are subject to FDA
regulation must also comply with regulations at 21 CFR Parts 50 and 56 regarding the
protection of human subjects and institutional review boards, respectively.
17. Legal: The study is not designed to exclusively test toxicity or disease
pathophysiology in healthy individuals, although it is acceptable for a study to test a
reduction in toxicity of a product relative to standard of care or an appropriate
comparator. For studies that involve researching the safety and effectiveness of new
drugs and biological products aimed at treating life-threatening or severely debilitating
diseases, refer to additional requirements set forth in 21 CFR § 312.81(a).

Consistent with section 1142 of the Social Security Act, AHRQ supports clinical research
studies that CMS determines meet all the criteria and standards identified above.
C. 	Other Uses of T-TEER
3. 	Tricuspid transcatheter edge-to-edge repair (T-TEER) is not covered for patients
outside of a CMS-approved study.
4. 	Nothing in this NCD would preclude coverage of T-TEER through NCD 310.1
(Clinical Trial Policy) or through the Investigational Device Exemption (IDE)
Policy.
(This NCD last reviewed July 2025.)
20.39 –Cardiac Contractility Modulation (CCM) for Heart Failure (HF)
(Rev. 13716; Issued: 04-03-26; Effective: 10-28-25; Implementation: 04-06-26)
A. 	General
Cardiac Contractility Modulation (CCM) is used in the treatment of heart failure (HF).
B. 	Nationally Covered Indications
The Centers for Medicare & Medicaid Services (CMS) covers CCM for HF management
under Coverage with Evidence Development (CED) when furnished according to a Food
and Drug Administration (FDA) market-authorized indication and all of the following
conditions are met:
7. 	Patient Criteria
Patients must meet the FDA market-authorized indications for use and remain
symptomatic despite at least 3 months of optimized guideline-directed medical therapy
(GDMT) as determined by the heart team prior to CCM implantation.
Patients are excluded from coverage if they meet any of the following criteria:
• 	Meet any of the contraindications in the FDA labeling; or,
• 	Have had a heart transplant; or,
• 	Are younger than 18 years old
8. 	CED Study Criteria
The CCM and related items and services are furnished in the context of a CMS-approved
CED study. CMS-approved CED study protocols must: include only those patients who
meet the criteria in section B.1; and include all of the following:

a) 	Primary outcomes of all-cause mortality, HF hospitalizations, or a composite of these,
through a minimum of 24 months. Each component of a composite outcome must be
individually reported.
b) An active comparator.
c) A care management plan that identifies members, roles, and responsibilities of the
clinical team that performs the follow-up CCM patient management.
d) Design sufficient for subgroup analyses by:
• Age (Stratify <65, 65-74, 75+)
• Other clinically important patient demographic factors
• Ischemic cardiomyopathy versus non-ischemic cardiomyopathy;
• No CRT, CRT (cardiac resynchronization therapy);
• Left ventricular ejection fraction (LVEF) ≥35% versus <35%;
• Systolic blood pressure ≥ median versus < median;
• Diabetic vs non-diabetic
e) In addition, CMS-approved CED studies must adhere to the following scientific
standards (criteria 1-17 below) that have been identified by the Agency for Healthcare
Research and Quality (AHRQ) as set forth in Section VI. of CMS’ Coverage with
Evidence Development Guidance Document, published August 7. 2024 (the “CED
Guidance Document”) https://www.cms.gov/medicare-coverage-database/view/medicare-
coverage-document.aspx?mcdid=38
1. Sponsor/Investigator: The study is conducted by sponsors/investigators with the
resources and skills to
complete it successfully.
2. Milestones: A written plan is in place that describes a detailed schedule for completion
of key study
milestones, including study initiation, enrollment progress, interim results reporting, and
results reporting, to ensure timely completion of the CED process.
3. Study Protocol: The CED study is registered with ClinicalTrials.gov and a complete
final protocol, including the statistical analysis plan, is delivered to CMS prior to study
initiation. The published protocol includes sufficient detail to allow a judgment of
whether the study is fit-for-purpose and whether reasonable efforts will be taken to
minimize the risk of bias. Any changes to approved study protocols should be explained
and publicly reported.
4. Study Context: The rationale for the study is supported by scientific evidence and
study results are expected to fill the specified CMS-identified evidence deficiency and
provide evidence sufficient to assess health outcomes.

5. Study Design: The study design is selected to safely and efficiently generate valid
evidence of health
outcomes. The sponsors/investigators minimize the impact of confounding and biases on
inferences through
rigorous design and appropriate statistical techniques. If a contemporaneous comparison
group is not included, this choice should be justified, and the sponsors/investigators
discuss in detail how the design contributes useful information on issues such as
durability or adverse event frequency that are not clearly answered in comparative
studies.
6. Study Population: The study population reflects the demographic and clinical diversity
among the Medicare beneficiaries who are the intended population of the intervention,
particularly when there is good clinical or scientific reason to expect that the results
observed in premarket studies might not be observed in older adults or subpopulations
identified by other clinical or demographic factors.
7. Subgroup Analyses: The study protocol explicitly discusses beneficiary subpopulations
affected by the item or service under investigation, particularly traditionally
underrepresented groups in clinical studies, how the inclusion and exclusion requirements
effect enrollment of these populations, and a plan for the retention and reporting of said
populations in the trial. In the protocol, the sponsors/investigators describe plans for
analyzing demographic subpopulations as well as clinically relevant subgroups as
identified in existing evidence. Description of plans for exploratory analyses, as relevant
subgroups emerge, are also included.
8. Care Setting: When feasible and appropriate for answering the CED question, data for
the study should come from beneficiaries in their expected sites of care.
9. Health Outcomes: The primary health outcome(s) for the study are those important to
patients and their
caregivers and that are clinically meaningful. A validated surrogate outcome that reliably
predicts these
outcomes may be appropriate for some questions. Generally, when study sponsors
propose using surrogate
endpoints to measure outcomes, they should cite validation studies published in peer-
reviewed journals to
provide a rationale for assuming these endpoints predict the health outcomes of interest.
The cited validation studies should be longitudinal and demonstrate a statistical
association between the surrogate endpoint and the health outcomes it is thought to
predict.
10. Objective Success Criteria: In consultation with CMS and AHRQ,
sponsors/investigators establish an
evidentiary threshold for the primary health outcome(s) to demonstrate clinically
meaningful differences with sufficient precision.

11. Data Quality: The data are generated or selected with attention to provenance, bias,
completeness, accuracy, sufficiency of duration of observation to demonstrate durability
of health outcomes, and sufficiency of sample size as required by the question.
12. Construct Validity: Sponsors/investigators provide information about the validity of
drawing warranted conclusions about the study population, primary exposure(s)
(intervention, control), health outcome measures, and core covariates when using either
primary data collected for the study about individuals or proxies of the variables of
interest, or existing (secondary) data about individuals or proxies of the variables of
interest.
13. Sensitivity Analyses: Sponsors/investigators will demonstrate robustness of results by
conducting prespecified sensitivity testing using alternative variable or model
specifications as appropriate.
14. Reporting: Final results are provided to CMS and submitted for publication or
reported in a publicly accessible manner within 12 months of the study’s primary
completion date. Wherever possible, the study is submitted for peer review with the goal
of publication using a reporting guideline appropriate for the study design and structured
to enable replication. If peer-reviewed publication is not possible, results may also be
published in an online 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 incomplete results).
15. Sharing: The sponsors/investigators commit to making study data publicly available
by sharing data,
methods, analytic code, and analytical output with CMS or with a CMS-approved third
party. The study should comply with all applicable laws regarding subject privacy,
including 45 CFR § 164.514 within the regulations promulgated under the Health
Insurance Portability and Accountability Act of 1996 (HIPAA) and 42 CFR, Part 2:
Confidentiality of Substance Use Disorder Patient Records.
16. Governance: The protocol describes the information governance and data security
provisions that have been established to satisfy Federal security regulations issued
pursuant to HIPAA and codified at 45 CFR Parts 160 and 164 (Subparts A & C), United
States Department of Health and Human Services (HHS) regulations at 42 CFR, Part 2:
Confidentiality of Substance Use Disorder Patient and HHS regulations at 45 CFR Part
46, regarding informed consent for clinical study involving human subjects. In addition to
the requirements under 42 CFR and 45 CFR, studies that are subject to FDA regulation
must also comply with regulations at 21 CFR Parts 50 and 56 regarding the protection of
human subjects and institutional review boards, respectively.
17. Legal: The study is not designed to exclusively test toxicity or disease
pathophysiology in healthy individuals, although it is acceptable for a study to test a
reduction in toxicity of a product relative to standard of care or an appropriate
comparator. For studies that involve researching the safety and effectiveness of new

drugs and biological products aimed at treating life-threatening or severely debilitating
diseases, refer to additional requirements set forth in 21 CFR § 312.81(a).
Consistent with section 1142 of the Social Security Act, AHRQ supports clinical research
studies that CMS determines meet all the criteria and standards identified above.
C. 	Other Uses of CCM
5. 	CCM for HF management is not covered for patients outside of a CMS-approved
study.
6. 	Nothing in this NCD would preclude coverage of CCM for HF management
through NCD 310.1 (Clinical Trial Policy) or through the Investigational Device
Exemption (IDE) Policy.
(This NCD last reviewed October 2025.)
20.39 –Cardiac Contractility Modulation (CCM) for Heart Failure (HF)
(Rev. 13806, Issued: 05-28-26, Effective: 10-28- 25, Implementation: 04- 06-26)
A. 	General
Cardiac Contractility Modulation (CCM) is used in the treatment of heart failure (HF).
B. 	Nationally Covered Indications
The Centers for Medicare & Medicaid Services (CMS) covers CCM for HF management
under Coverage with Evidence Development (CED) when furnished according to a Food
and Drug Administration (FDA) market-authorized indication and all of the following
conditions are met:
9. 	Patient Criteria
Patients must meet the FDA market-authorized indications for use and remain
symptomatic despite at least 3 months of optimized guideline-directed medical therapy
(GDMT) as determined by the heart team prior to CCM implantation.
Patients are excluded from coverage if they meet any of the following criteria:
• 	Meet any of the contraindications in the FDA labeling; or,
• 	Have had a heart transplant; or,
• 	Are younger than 18 years old
10. CED Study Criteria

The CCM and related items and services are furnished in the context of a CMS-approved
CED study. CMS-approved CED study protocols must: include only those patients who
meet the criteria in section B.1; and include all of the following:
a) 	Primary outcomes of all-cause mortality, HF hospitalizations, or a composite of
these, through a minimum of 24 months. Each component of a composite outcome must
be individually reported.
b) An active comparator.
c) A care management plan that identifies members, roles, and responsibilities of the
clinical team that performs the follow-up CCM patient management.
d) Design sufficient for subgroup analyses by:
• Age (Stratify <65, 65-74, 75+)
• Other clinically important patient demographic factors
• Ischemic cardiomyopathy versus non-ischemic cardiomyopathy;
• No CRT, CRT (cardiac resynchronization therapy);
• Left ventricular ejection fraction (LVEF) ≥35% versus <35%;
• Systolic blood pressure ≥ median versus < median;
• Diabetic vs non-diabetic
e) In addition, CMS-approved CED studies must adhere to the following scientific
standards (criteria 1-17 below) that have been identified by the Agency for Healthcare
Research and Quality (AHRQ) as set forth in Section VI. of CMS’ Coverage with
Evidence Development Guidance Document, published August 7. 2024 (the “CED
Guidance Document”) https://www.cms.gov/medicare-coverage-
database/view/medicare-coverage-document.aspx?mcdid=38
1. Sponsor/Investigator: The study is conducted by sponsors/investigators with the
resources and skills to complete it successfully.
2. Milestones: A written plan is in place that describes a detailed schedule for completion
of key study milestones, including study initiation, enrollment progress, interim results
reporting, and results reporting, to ensure timely completion of the CED process.
3. Study Protocol: The CED study is registered with ClinicalTrials.gov and a complete
final protocol, including the statistical analysis plan, is delivered to CMS prior to study
initiation. The published protocol includes sufficient detail to allow a judgment of
whether the study is fit-for-purpose and whether reasonable efforts will be taken to
minimize the risk of bias. Any changes to approved study protocols should be explained
and publicly reported.

4. Study Context: The rationale for the study is supported by scientific evidence and study
results are expected to fill the specified CMS-identified evidence deficiency and provide
evidence sufficient to assess health outcomes.
5. Study Design: The study design is selected to safely and efficiently generate valid
evidence of health outcomes. The sponsors/investigators minimize the impact of
confounding and biases on inferences through rigorous design and appropriate statistical
techniques. If a contemporaneous comparison group is not included, this choice should
be justified, and the sponsors/investigators discuss in detail how the design contributes
useful information on issues such as durability or adverse event frequency that are not
clearly answered in comparative studies.
6. Study Population: The study population reflects the demographic and clinical diversity
among the Medicare beneficiaries who are the intended population of the intervention,
particularly when there is good clinical or scientific reason to expect that the results
observed in premarket studies might not be observed in older adults or subpopulations
identified by other clinical or demographic factors.
7. Subgroup Analyses: The study protocol explicitly discusses beneficiary subpopulations
affected by the item or service under investigation, particularly traditionally
underrepresented groups in clinical studies, how the inclusion and exclusion
requirements effect enrollment of these populations, and a plan for the retention and
reporting of said populations in the trial. In the protocol, the sponsors/investigators
describe plans for analyzing demographic subpopulations as well as clinically relevant
subgroups as identified in existing evidence. Description of plans for exploratory
analyses, as relevant subgroups emerge, are also included.
8. Care Setting: When feasible and appropriate for answering the CED question, data for
the study should come from beneficiaries in their expected sites of care.
9. Health Outcomes: The primary health outcome(s) for the study are those important to
patients and their caregivers and that are clinically meaningful. A validated surrogate
outcome that reliably predicts these outcomes may be appropriate for some questions.
Generally, when study sponsors propose using surrogate endpoints to measure outcomes,
they should cite validation studies published in peer-reviewed journals to provide a
rationale for assuming these endpoints predict the health outcomes of interest. The cited
validation studies should be longitudinal and demonstrate a statistical association
between the surrogate endpoint and the health outcomes it is thought to predict.
10. Objective Success Criteria: In consultation with CMS and AHRQ,
sponsors/investigators establish an evidentiary threshold for the primary health
outcome(s) to demonstrate clinically meaningful differences with sufficient precision.
11. Data Quality: The data are generated or selected with attention to provenance, bias,
completeness, accuracy, sufficiency of duration of observation to demonstrate durability
of health outcomes, and sufficiency of sample size as required by the question.

12. Construct Validity: Sponsors/investigators provide information about the validity of
drawing warranted conclusions about the study population, primary exposure(s)
(intervention, control), health outcome measures, and core covariates when using either
primary data collected for the study about individuals or proxies of the variables of
interest, or existing (secondary) data about individuals or proxies of the variables of
interest.
13. Sensitivity Analyses: Sponsors/investigators will demonstrate robustness of results by
conducting prespecified sensitivity testing using alternative variable or model
specifications as appropriate.
14. Reporting: Final results are provided to CMS and submitted for publication or
reported in a publicly accessible manner within 12 months of the study’s primary
completion date. Wherever possible, the study is submitted for peer review with the goal
of publication using a reporting guideline appropriate for the study design and structured
to enable replication. If peer-reviewed publication is not possible, results may also be
published in an online 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 incomplete results).
15. Sharing: The sponsors/investigators commit to making study data publicly available
by sharing data, methods, analytic code, and analytical output with CMS or with a CMS-
approved third party. The study should comply with all applicable laws regarding subject
privacy, including 45 CFR § 164.514 within the regulations promulgated under the
Health Insurance Portability and Accountability Act of 1996 (HIPAA) and 42 CFR, Part
2: Confidentiality of Substance Use Disorder Patient Records.
16. Governance: The protocol describes the information governance and data security
provisions that have been established to satisfy Federal security regulations issued
pursuant to HIPAA and codified at 45 CFR Parts 160 and 164 (Subparts A & C), United
States Department of Health and Human Services (HHS) regulations at 42 CFR, Part 2:
Confidentiality of Substance Use Disorder Patient and HHS regulations at 45 CFR Part
46, regarding informed consent for clinical study involving human subjects. In addition
to the requirements under 42 CFR and 45 CFR, studies that are subject to FDA
regulation must also comply with regulations at 21 CFR Parts 50 and 56 regarding the
protection of human subjects and institutional review boards, respectively.
17. Legal: The study is not designed to exclusively test toxicity or disease
pathophysiology in healthy individuals, although it is acceptable for a study to test a
reduction in toxicity of a product relative to standard of care or an appropriate
comparator. For studies that involve researching the safety and effectiveness of new
drugs and biological products aimed at treating life-threatening or severely debilitating
diseases, refer to additional requirements set forth in 21 CFR § 312.81(a).

Consistent with section 1142 of the Social Security Act, AHRQ supports clinical research
studies that CMS determines meet all the criteria and standards identified above.
C. 	Other Uses of CCM
7. 	CCM for HF management is not covered for patients outside of a CMS-approved
study.
8. 	Nothing in this NCD would preclude coverage of CCM for HF management
through NCD 310.1 (Clinical Trial Policy) or through the Investigational Device
Exemption (IDE) Policy.
(This NCD last reviewed October 2025.)
20.40 – Renal Denervation for Uncontrolled Hypertension
(Rev. 13802; Issued: 05-28-26; Effective: 10-28-25; Implementation: 04-06-26)
A. 	General
Renal Denervation (RDN) is used in the treatment of uncontrolled hypertension.
B. 	Coverage Criteria
The Centers for Medicare & Medicaid Services (CMS) covers radiofrequency renal
denervation (rfRDN) and ultrasound renal denervation (uRDN) (collectively RDN) for
uncontrolled hypertension when furnished according to a Food and Drug Administration
(FDA) market-authorized indication and all the following conditions are met:
1. 	Patient Criteria
The patient meets all the following criteria:
(a) Diagnosis of uncontrolled hypertension (≥ 140 mm Hg systolic blood pressure and >
90 mm Hg diastolic blood pressure) despite active management by a clinician with
primary responsibility for blood pressure management.
(b) Uncontrolled hypertension diagnosed using either ambulatory blood pressure
monitoring or serial home blood pressure readings.
(c) On lifestyle modifications and stable doses of maximally tolerated guideline-directed
medical therapy (GDMT), with assessment of adherence to the prescribed regimen, for at
least six weeks before referral for RDN.
(d) As clinically appropriate, secondary hypertension must be evaluated and treated
before determining that blood pressure remains uncontrolled. At a minimum, patients
must be screened for primary aldosteronism, obstructive sleep apnea, and drug or
alcohol induced hypertension before referral to RDN.

(e) The patient has no contraindications to RDN, consistent with the FDA labeling of the
device used.
(f) The primary clinicians must coordinate management of the patient for a minimum of
six months before referral for RDN, during which the patient had at least three
encounters, with no more than two of the three encounters being virtual.
(g) No prior RDN procedure.
2. 	Physician Criteria
RDN is furnished by clinicians who meet the following criteria, as applicable:
(a) Clinicians referring Medicare beneficiaries must have longitudinal responsibility for
hypertension management.
(b) Physicians performing RDN must have interventional and endovascular skills to
perform effective RDN treatments. Additionally, they must be able to manage potential
complications either themselves or with institutional support from colleagues who are
immediately available to assist in emergency management.
(c) Physicians performing RDN without prior endovascular training or renovascular
expertise must complete at least ten supervised cases of diagnostic/therapeutic
renovascular procedures, half as primary operator. Additionally, they must complete at
least five proctored RDN cases with each approved device used in their practice.
(d) Physicians performing RDN with prior endovascular training and active
endovascular experience must complete at least five proctored RDN cases with each
approved device used in their practice.
3. 	Facility Criteria
The RDN device and related items and services are furnished at facilities meeting the
following criteria:
(a) Facilities performing RDN must have a hypertension program with contributions
from a hypertension clinician with longitudinal patient management responsibility, a
hypertension navigator, and access to relevant medical specialties (e.g., internal
medicine, endocrinology, sleep medicine, cardiology, and nephrology) as appropriate.
(b) Preprocedural imaging capabilities (e.g., ultrasound, Computed Tomography
Angiography, Magnetic Resonance Angiography).
(c) An appropriate interventional cardiology or radiology suite.
4. 	CED Study Criteria

The RDN device and related items and services are furnished in the context of a CMS-
approved CED study. CMS-approved CED study protocols must: include only those
patients who meet the criteria in section B.1; furnish items and services only through
practitioners who meet the criteria in section B.2; furnish items and services at facilities
meeting the criteria in section B.3; and include all of the following:
(a) One or more primary outcomes of ambulatory systolic blood pressure (ASBP),
ambulatory diastolic blood pressure (ADBP), home systolic blood pressure (HSBP),
home diastolic blood pressure (HDBP), office systolic blood pressure (OSBP), office
diastolic blood pressure (ODBP), worsening renal function, cerebrovascular accident,
acute myocardial infarction, incidence of new-onset heart failure, cardiovascular
mortality, all-cause mortality, or a composite of these, through a minimum of 24
months. Each component of a composite outcome must be individually reported.
(b) An active comparator.
(c) Design sufficient for subgroup analyses by:
• 	Age (Stratify <65, 65-74, 75+);
• 	Other clinically important patient demographic factors;
• 	Chronic kidney disease (Stratify by CKD Stages);
• 	Progression of CKD;
• 	Hypertension phenotype (e.g., resistant hypertension vs. uncontrolled for any
reason);
• 	Medication adherence.
(d) 	In addition, CMS-approved CED studies must adhere to the scientific standards
(criteria 1-17 below) that have been identified by the Agency for Healthcare Research
and Quality (AHRQ) as set forth in Section VI. of CMS’ Coverage with Evidence
Development Guidance Document, published August 7, 2024 (the “CED Guidance
Document”).
1. 	Sponsor/Investigator: The study is conducted by sponsors/investigators with the
resources and skills to complete it successfully.
2. 	Milestones: A written plan is in place that describes a detailed schedule for
completion of key study milestones, including study initiation, enrollment
progress, interim results reporting, and results reporting, to ensure timely
completion of the CED process.
3. 	Study Protocol: The CED study is registered with ClinicalTrials.gov and a
complete final protocol, including the statistical analysis plan, is delivered to

CMS prior to study initiation. The published protocol includes sufficient detail to
allow a judgment of whether the study is fit-for-purpose and whether reasonable
efforts will be taken to minimize the risk of bias. Any changes to approved study
protocols should be explained and publicly reported.
4. 	Study Context: The rationale for the study is supported by scientific evidence and
study results are expected to fill the specified CMS-identified evidence deficiency
and provide evidence sufficient to assess health outcomes.
5. 	Study Design: The study design is selected to safely and efficiently generate valid
evidence of health outcomes. The sponsors/investigators minimize the impact of
confounding and biases on inferences through rigorous design and appropriate
statistical techniques. If a contemporaneous comparison group is not included,
this choice should be justified, and the sponsors/investigators discuss in detail
how the design contributes useful information on issues such as durability or
adverse event frequency that are not clearly answered in comparative studies.
6. 	Study Population: The study population reflects the demographic and clinical
diversity among the Medicare beneficiaries who are the intended population of
the intervention, particularly when there is good clinical or scientific reason to
expect that the results observed in premarket studies might not be observed in
older adults or subpopulations identified by other clinical or demographic
factors.
7. 	Subgroup Analyses: The study protocol explicitly discusses beneficiary
subpopulations affected by the item or service under investigation, particularly
traditionally underrepresented groups in clinical studies, how the inclusion and
exclusion requirements effect enrollment of these populations, and a plan for the
retention and reporting of said populations in the trial. In the protocol, the
sponsors/investigators describe plans for analyzing demographic subpopulations
as well as clinically-relevant subgroups as identified in existing evidence.
Description of plans for exploratory analyses, as relevant subgroups emerge, are
also included.
8. 	Care Setting: When feasible and appropriate for answering the CED question,
data for the study should come from beneficiaries in their expected sites of care.
9. 	Health Outcomes: The primary health outcome(s) for the study are those
important to patients and their caregivers and that are clinically meaningful. A
validated surrogate outcome that reliably predicts these outcomes may be
appropriate for some questions. Generally, when study sponsors propose using
surrogate endpoints to measure outcomes, they should cite validation studies
published in peer-reviewed journals to provide a rationale for assuming these

endpoints predict the health outcomes of interest. The cited validation studies
should be longitudinal and demonstrate a statistical association between the
surrogate endpoint and the health outcomes it is thought to predict.
10. Objective Success Criteria: In consultation with CMS and AHRQ,
sponsors/investigators establish an evidentiary threshold for the primary health
outcome(s) so as to demonstrate clinically meaningful differences with sufficient
precision.
11. Data Quality: The data are generated or selected with attention to provenance,
bias, completeness, accuracy, sufficiency of duration of observation to
demonstrate durability of health outcomes, and sufficiency of sample size as
required by the question.
12. Construct Validity: Sponsors/investigators provide information about the validity
of drawing warranted conclusions about the study population, primary
exposure(s) (intervention, control), health outcome measures, and core covariates
when using either primary data collected for the study about individuals or
proxies of the variables of interest, or existing (secondary) data about individuals
or proxies of the variables of interest.
13. Sensitivity Analyses: Sponsors/investigators will demonstrate robustness of
results by conducting pre-specified sensitivity testing using alternative variable or
model specifications as appropriate.
14. Reporting: Final results are provided to CMS and submitted for publication or
reported in a publicly accessible manner within 12 months of the study’s primary
completion date. Wherever possible, the study is submitted for peer review with
the goal of publication using a reporting guideline appropriate for the study
design and structured to enable replication. If peer-reviewed publication is not
possible, results may also be published in an online 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 incomplete results).
15. Sharing: The sponsors/investigators commit to making study data publicly
available by sharing data, methods, analytic code, and analytical output with
CMS or with a CMS-approved third party. The study should comply with all
applicable laws regarding subject privacy, including 45 CFR § 164.514 within
the regulations promulgated under the Health Insurance Portability and
Accountability Act of 1996 (HIPAA) and 42 CFR, Part 2: Confidentiality of
Substance Use Disorder Patient Records.

16. Governance: The protocol describes the information governance and data
security provisions that have been established to satisfy Federal security
regulations issued pursuant to HIPAA and codified at 45 CFR Parts 160 and 164
(Subparts A & C), United States Department of Health and Human Services
(HHS) regulations at 42 CFR, Part 2: Confidentiality of Substance Use Disorder
Patient and HHS regulations at 45 CFR Part 46, regarding informed consent for
clinical study involving human subjects. In addition to the requirements under 42
CFR and 45 CFR, studies that are subject to FDA regulation must also comply
with regulations at 21 CFR Parts 50 and 56 regarding the protection of human
subjects and institutional review boards, respectively.
17. Legal: The study is not designed to exclusively test toxicity or disease
pathophysiology in healthy individuals, although it is acceptable for a study to
test a reduction in toxicity of a product relative to standard of care or an
appropriate comparator. For studies that involve researching the safety and
effectiveness of new drugs and biological products aimed at treating life-
threatening or severely-debilitating diseases, refer to additional requirements set
forth in 21 CFR § 312.81(a).
Consistent with section 1142 of the Act, AHRQ supports clinical research studies that
CMS determines meet all the criteria and standards identified above.
C. 	National Non-Covered Indications
RDN is not covered for patients outside of a CMS-approved study.
D. Other
Nothing in this NCD would preclude coverage of RDN through NCD 310.1 (Clinical
Trial Policy) or through the Investigational Device Exemption (IDE) Policy.
(This NCD last reviewed October 28, 2025)
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 Sydenham’s 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 acupuncture’s 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 acupuncture’s 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:
o 	Lasting 12 weeks or longer;
o 	nonspecific, in that it has no identifiable systemic cause (i.e., not
associated with metastatic, inflammatory, infectious, etc. disease);
o 	not associated with surgery; and,
o 	not associated with pregnancy.
• 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 patient’s 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 patient’s 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 patient’s 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 patient’s 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 patient’s 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 physician’s 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 patient’s
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 patient’s 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 user’s 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 Meniere’s
Disease
(Rev. 1, 10-03-03)
CIM 35-50
Not Covered
Meniere’s disease (or syndrome) is a common cause of paroxysmal vertigo. Meniere’s
syndrome is usually treated medically. When medical treatment fails, surgical treatment
may be required.
While there are two recognized surgical procedures used in treating Meniere’s 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 Meniere’s syndrome. Accordingly, Medicare does not cover
cochleostomy with neurovascular transplant for treatment of Meniere’s 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 Meniere’s 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 Beneficiary’s 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 patient’s relatives or associates for
this purpose, expenses of such interviews are properly chargeable as physician’s 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 patient’s 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 patient’s condition.
For example, two situations where family counseling services would be appropriate are
as follows: (1) where there is a need to observe the patient’s 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 patient’s condition on the individual being interviewed would not
be reimbursable as part of the physician’s 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 patient’s problems and not to the treatment of
the family member’s problems.
Cross-references:
The Medicare Benefit Policy Manual, Chapter 6, “Hospital Services Covered Under Part
B,Ӥ20.
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 regulation’s 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 - Physician’s Office within an Institution - Coverage of Services
and Supplies Incident to a Physician’s 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 Physician’s 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 physician’s 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 physician’s office. A physician’s office within an
institution must be confined to a separately identified part of the facility which is used
solely as the physician’s 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 physician’s
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 physician’s offices generally, even though such services may
be furnished in his institutional office. Additionally, make a distinction between the
physician’s 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 institution’s staff, and the cost of supplies must represent an expense to the
physician’s 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
“physician’s 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 physician’s 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
patient’s 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, Mooren’s 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 physician’s service. Payment for the lens is included in the payment for the
physician’s 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 drug’s 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 Medicare’s 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 physician’s
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 Medicare’s 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 physician’s 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
R13806NCD 	05/28/2026 	Cardiac Contractility Modulation
(CCM) for Heart Failure (HF)
04/06/2026 	14311
R13802NCD 	05/28/2026 	NCD 20.40- Renal Denervation
(RDN) for Uncontrolled
Hypertension
04/06/2026 	14302
R13801NCD 	05/28/2026 	NCD 20.38 - Transcatheter Edge-
to-Edge Repair for Tricuspid
Valve Regurgitation (T-TEER)
01/05/2026 	14200
R13800NCD 	05/28/2026 	NCD 20.37 - Transcatheter
Tricuspid Valve Replacement
(TTVR)
01/05/2026 	14149
R13716NCD 	04/03/2026 	Cardiac Contractility Modulation
(CCM) for Heart Failure (HF)- -
Rescinded and replaced by
Transmittal 13806
04/06/2026 	14311
R13695NCD 	03/19/2026 	NCD 20.40- Renal Denervation
(RDN) for Uncontrolled
Hypertension- Rescinded and
replaced by Transmittal 13802
04/06/2026 	14302
R13672NCD 	03/09/2026 	Cardiac Contractility Modulation
(CCM) for Heart Failure (HF)-
Rescinded and replaced by
Transmittal 13716
04/06/2026 	14311
R13640NCD 	02/13/2026 	NCD 20.40- Renal Denervation
(RDN) for Uncontrolled
Hypertension- Rescinded and
replaced by Transmittal 13695
04/06/2026 	14302
R13612NCD 	01/30/2026 	NCD 20.40- Renal Denervation
(RDN) for Uncontrolled
Hypertension- Rescinded and
replaced by Transmittal 13640
04/06/2026 	14302
R13538NCD 	12/19/2025 	Cardiac Contractility Modulation
(CCM) for Heart Failure (HF)-
Rescinded and replaced by
Transmittal 13672
04/06/2026 	14311
R13522NCD 	12/11/2025 	NCD 20.40- Renal Denervation
(RDN) for Uncontrolled
Hypertension-- Rescinded and
replaced by Transmittal 13612
04/06/2026 	14302
R13427NCD 	09/22/2025 	NCD 20.37 - Transcatheter
Tricuspid Valve Replacement
(TTVR)- Rescinded and replaced
by Transmittal 13800
01/05/2026 	14149

Rev.# 	Issue Date 	Subject 	Impl. Date 	CR
R13366NCD 	08/14/2025 	NCD 20.38 - Transcatheter Edge-
to-Edge Repair for Tricuspid
Valve Regurgitation (T-TEER)-
Rescinded and replaced by
Transmittal 13801
01/05/2026 	14200
R13343NCD 	07/31/2025 	NCD 20.37 - Transcatheter
Tricuspid Valve Replacement
(TTVR)- Rescinded and replaced
by Transmittal 13427
01/05/2026 	14149
R12571NCD 	04/11/2024 	National Coverage Determination
(NCD) 20.7 Percutaneous
Transluminal Angioplasty (PTA)
of the Carotid Artery Concurrent
with Stenting
05/13/2024 	13512
R12112NCD 	06/29/2023 	Technical Revisions Only to the
National Coverage Determination
(NCD) Manual, Publication (Pub)
100-03
07/31/2023 	13220
R11892NCD 	03/09/2023 	Technical Revisions Only to the
National Coverage Determination
(NCD) Manual
04/10/2023 	13105
R11875NCD 	02/23/2023 	National Coverage Determination
(NCD) 50.3 - Cochlear
Implantation Manual Update
03/24/2023 	13073
R10985NCD 	09/08/2021 	Claims Processing Instructions for
National Coverage Determination
20.33 - Transcatheter Edge-to-
Edge Repair [TEER] for Mitral
Valve Regurgitation
10/08/2021 	12361
R10838NCD 	06/08/2021 	National Coverage Determination
(NCD) Removal
06/22/2021 	12254
R10837NCD 	06/11/2021 	National Coverage Determination
(NCD) 20.9.1 Ventricular Assist
Devices (VADs)
07/27/2021 	12290
R10797NCD 	05/20/2021 	National Coverage Determination
(NCD) Removal- Rescinded and
replaced by Transmittal 10838
06/22/2021 	12254
R10337NCD 	08/27/2020 	National Coverage Determination
(NCD30.3.3): Acupuncture for
Chronic Low Back Pain (cLBP)
10/05/2020 	11755
R10128NCD 	05/08/2020 	National Coverage Determination
(NCD30.3.3): Acupuncture for
Chronic Low Back Pain (cLBP)-
Rescinded and replaced by
10/05/2020 	11755

Rev.# 	Issue Date 	Subject 	Impl. Date 	CR
Transmittal 10337
R10073NCD 	05/01/2020 	National Coverage Determination
(NCD) 20.19 Ambulatory Blood
Pressure Monitoring (ABPM)
06/16/2020 	11650
R10179NCD 	06/10/2020 	NCD (20.32) Transcatheter Aortic
Valve Replacement (TAVR)
06/12/2020 	11660
R217NCD 	03/13/2020 	NCD (20.32) Transcatheter Aortic
Valve Replacement (TAVR)-
Rescinded and replaced by
Transmittal 10179
06/12/2020 	11660
R213NCD 	02/15/2019 	National Coverage Determination
(NCD) 20.4 Implantable Cardiac
Defibrillators (ICDs)
03/26/2019 	10865
R209NCD 	11/21/2018 	National Coverage Determination
(NCD) 20.4 Implantable Cardiac
Defibrillators (ICDs) – Rescinded
and replaced by Transmittal 211
02/26/2019 	10865
R212NCD 	01/18/2019 	Update to Pub. 100-03 to Provide
Language-Only Changes for the
New Medicare Card Project
02/19/2019 	11118
R207NCD 	05/11/2018 	Supervised Exercise Therapy
(SET) for Symptomatic Peripheral
Artery Disease (PAD)
07/02/2018 	10295
R206NCD 	04/03/2018 	Supervised Exercise Therapy
(SET) for Symptomatic Peripheral
Artery Disease (PAD)- Rescinded
and replaced by Transmittal 207
07/02/2018 	10295
R204NCD 	02/02/2018 	Supervised Exercise Therapy
(SET) for Symptomatic Peripheral
Artery Disease (PAD)
04/03/2018 	10295
R203NCD 	11/17/2017 	Hyperbaric Oxygen (HBO)
Therapy (Section C, Topical
Application of Oxygen)
12/18/2017 	10220
R201NCD 	08/28/2017 	National Coverage Determination
(NCD20.8.4): Leadless
Pacemakers
08/29/2017 	10117
R192NCD 	05/06/2016 	Percutaneous Left Atrial
Appendage Closure (LAAC)
10/03/2016 	9638
R187NCD 	12/102015 	National Coverage Determination
(NCD) for Single Chamber and
Dual Chamber Permanent Cardiac
Pacemakers - This CR rescinds
and fully replaces CR 8525
01/13/2016 	9078

Rev.# 	Issue Date 	Subject 	Impl. Date 	CR
R186NCD 	10/26/2015 	National Coverage Determination
(NCD) for Single Chamber and
Dual Chamber Permanent Cardiac
Pacemakers - This CR rescinds
and fully replaces CR 8525 –
Rescinded and replaced by
Transmittal 187
07/06/2015 	9078
R184NCD 	08/21/2015 	Update to Pub. 100-03, National
Coverage Determination Manual,
Chapter 1, Part 1, Section 50.1
Speech Generating Device
09/21/2015 	9281
R182NCD 	05/22/2015 	NCD20.30 Microvolt T-wave
Alternans (MTWA)
06/23/2015 	9162
R180NCD 	03/06/2015 	Removal of Multiple National
Coverage Determinations Using
Expedited Process
04/06/2015 	9095
R179NCD 	02/20/2015 	National Coverage Determination
(NCD) for Single Chamber and
Dual Chamber Permanent Cardiac
Pacemakers - This CR rescinds
and fully replaces CR 8525 –
Rescinded and replaced by
Transmittal 186
07/06/2015 	9078
R178NCD 	12/05/2014 	Transcatheter Mitral Valve Repair
(TMVR)-National Coverage
Determination (NCD)
04/06/2015 	9002
R175NCD 	10/03/2014 	Intensive Cardiac Rehabilitation
Program - Benson-Henry Institute
Cardiac Wellness Program
11/04/2014 	8894
R173NCD 	09/04/2014 	Pub 100-03, Chapter 1, Language-
only Update
Upon
Implement
ation of
ICD-10
8506
R172NCD 	08/29/2014 	Ventricular Assist Devices for
Bridge-to-Transplant and
Destination Therapy
09/30/2014 	8803
R170NCD 	07/10/2014 	National Coverage Determination
(NCD) for Single Chamber and
Dual Chamber Permanent Cardiac
Pacemakers – Fully rescinded and
replaced by CR 9078
To Be
Determined
8525
R161NCD 	02/06/2014 	National Coverage Determination
(NCD) for Single Chamber and
Dual Chamber Permanent Cardiac
07/07/2014 	8525

Rev.# 	Issue Date 	Subject 	Impl. Date 	CR
Pacemakers – Rescinded and
replaced by Transmittal 170
R159NCD 	02/05/2014 	Pub 100-03, Chapter 1, Language-
only Update – Rescinded and
replaced by Transmittal 173
10/01/2014 	8506
R158NCD 	12/23/2013 	Bariatric Surgery for Treatment of
Co-Morbid Conditions Related to
Morbid Obesity
12/17/2013 	8484
R157NCD 	11/15/2013 	Bariatric Surgery for Treatment of
Co-Morbid Conditions Related to
Morbid Obesity – Rescinded and
replaced by Transmittal 158
12/17/2013 	8484
R155NCD 	06/14/2013 	Ocular Photodynamic Therapy
(OPT) with Verteporfin for
Macular Degeneration
07/16/2013 	8292
R151NCD 	02/08/2013 	Change of Address for
Percutaneous Transluminal
Angioplasty (PTA) of the Carotid
Artery Concurrent with Stenting
Facility Approval and
Recertification Letter Submission
03/11/2013 	8199
R149NCD 	11/30/2012 	Transcutaneous Electrical Nerve
Stimulation (TENS) for Chronic
Low Back Pain (CLBP)
01/07/2013 	7836
R147NCD 	09/24/2012 	National Coverage Determination
(NCD) for Transcatheter Aortic
Valve Replacement
01/07/2013 	7897
R145NCD 	08/03/2012 	National Coverage Determination
(NCD) for Transcatheter Aortic
Valve Replacement – Rescinded
and replaced by Transmittal 147
01/07/2013 	7897
R144NCD 	08/03/2012 	Transcutaneous Electrical Nerve
Stimulation (TENS) for Chronic
Low Back Pain (CLBP) –
Rescinded and replaced by
Transmittal 149
01/07/2013 	7836
R129NCD 	12/08/2010 	Ventricular Assist Devices (VAD)
as Destination Therapy
01/06/2011 	7220
R128NCD 	11/19/2010 	Ventricular Assist Devices (VAD)
as Destination Therapy -
Rescinded and replaced by
Transmittal 129
01/06/2011 	7220
R125NCD 	09/24/2010 	Intensive Cardiac Rehabilitation
(ICR) Programs-Dr. Ornish’s
10/25/2010 	7113

Rev.# 	Issue Date 	Subject 	Impl. Date 	CR
Program for Reversing Heart
Disease and the Pritikin Program
R117NCD 	03/09/2010 	Outpatient Intravenous Insulin
Treatment (Therapy)
04/05/2010 	6775
R116NCD 	03/05/2010 	Repeal of Section 20.10, Cardiac
Rehabilitation (CR) Program
04/05/2010 	6855
R115NCD 	03/05/2010 	Percutaneous Transluminal
Angioplasty (PTA) of the Carotid
Artery Concurrent With Stenting
04/05/2010 	6839
R114NCD 	02/22/2010 	Outpatient Intravenous Insulin
Treatment (Therapy) – Rescinded
and replaced by Transmittal 117
03/08/2010 	6775
R112NCD 	02/05/2010 	Outpatient Intravenous Insulin
Treatment (Therapy) - Rescinded
and replaced by Transmittal 114
03/08/2010 	6775
R98NCD 	12/24/2008 	Percutaneous Transluminal
Angioplasty of the Carotid Artery
Concurrent With Stenting
01/26/2009 	6301
R95NCD 	09/10/2008 	Artificial Hearts 	12/01/2008 	6185
R93NCD 	08/29/2008 	Artificial Hearts - Replaced by
Transmittal 95
10/06/2008 	6185
R88NCD 	07/25/2008 	Microvolt T-Wave Alterans
(MTWA)
08/25/2008 	6154
R87NCD 	07/11/2008 	Percutaneous Transluminal
Angioplasty (PTA) With Stenting
08/11/2008 	6137
R81NCD 	04/04/2008 	Percutaneous Transluminal
Angioplasty (PTA)
05/05/2008 	5984
R77NCD 	09/12/2007 	Percutaneous Transluminal
Angioplasty (PTA)
07/30/2007 	5660
R71NCD 	06/29/2007 	Percutaneous Transluminal
Angioplasty (PTA) - Replaced by
Transmittal 77
07/30/2007 	5660
R68NCD 	04/13/2007 	Ventricular Assist Devices
(VADs)
05/14/2007 	5516
R64NCD 	01/05/2007 	Intracranial Percutaneous
Transluminal Angioplasty (PTA)
with Stenting
02/05/2007 	5432
R63NCD 	12/15/2006 	Cardiac Output Monitoring by
Thoracic Electrical Bioimpedance
(TEB)
01/16/2007 	5414
R54NCD 	04/28/2006 	Bariatric Surgery for Treatment of
Morbid Obesity
05/30/2006 	5013
R53NCD 	04/21/2006 	Clarification on Billing
Requirements for Percutaneous
Transluminal Angioplasty (PTA)
N/A 	5022

Rev.# 	Issue Date 	Subject 	Impl. Date 	CR
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
Therapy
04/03/2006 	4350
R49NCD 	03/24/2006 	Microvolt T-Wave Alternans
(MTWA) Diagnostic Testing
04/03/2006 	4351
R48NCD 	03/17/2006 	Technical Corrections to the NCD
Manual
06/19/2006 	4278
R46NCD 	01/27/2006 	Cardiac Catheterization Performed
in Other Than a Hospital Setting
02/27/2006 	4280
R42NCD 	07/01/2005 	Cochlear Implantation 	07/25/2005 	3796
R39NCD 	06/24/2005 	Cochlear Implantation - Replaced
by Revision 42
07/05/2005 	3796
R33NCD 	04/22/2005 	Percutaneous Transluminal
Angioplasty (PTA
07/05/2005 	3811
R29NCD 	03/04/2005 	Implantable Automatic
Defibrillators
04/04/2005 	3604
R26NCD 	12/10/2004 	Electrocardiographic Services 	10/10/2004 	3590
R25NCD 	10/15/2004 	Percutaneous Transluminal
Angioplasty (PTA)
10/12/2004 	3489
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
Revision 16
04/30/2004 	3290
R11NCD 	04/16/2004 	Noncoverage of Acupuncture for
Fibromyalgia/Osteoarthritis
04/06/2004 	3250
R10NCD 	04/06/2004 	Re-release of NCD Manual 	N/A 	N/A
R09NCD 	04/01/2004 	NCD - Ocular Photodynamic
Therapy (OPT) With Verteporfin
for Age-Related Macular
Degeneration (AMD)
04/01/2004 	3191
R06NCD 	01/23/2004 	Cardiac Output Monitoring by
Thoracic Electrical Bioimpedance
02/23/2004 	2689
R02NCD 	10/17/2003 	Artificial hearts and Related
Devices
10/01/2003 	2958
R01NCD 	10/01/2003 	Initial Release of Manual 	N/A 	N/A
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