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What is a National Coverage Determination (NCD)?

Before deciding whether Medicare should cover a particular item (such as a brace or a hearing aid) or a service (such as therapy or screenings), the federal government conducts a comprehensive review process, and occasionally Congress may pass a law requiring coverage of a particular item or service. After coverage determinations or decisions are authorized, Medicare coverage is modified and Medicare carriers and other contractors (including Medicare Advantage organizations) coordinate their processes to fulfill these new coverage obligations. The formal name for these decisions which allow, limit, or exclude Medicare coverage is known as a National Coverage Determination (NCD). Coverage guidelines and effective dates are defined by Medicare or other rule making authority.

Below are changes that have occurred in the past year. It will be updated periodically. For more information, please contact Customer Service Monday through Friday from 8 a.m. to 8 p.m. at 541-768-4550 or toll free 800-832-4580. TTY users should call 800-735-2900.

NCD Change Description

July 29, 2015

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.

Feb. 5, 2015

Lung cancer is the third most common cancer and the leading cause of cancer deaths in the United States. Cancer of the lung and bronchus accounted for over 150,000 deaths in 2013, with a median age at death of 72 years. Computed tomography (CT) is an imaging procedure that uses specialized x-ray equipment to create detailed pictures of areas inside the body. Low dose computed tomography (LDCT) is a chest CT scan performed at settings to minimize radiation exposure compared to a standard chest CT. Screening for lung cancer with LDCT is not currently covered under the Medicare program.

Under §1861(ddd) of the Social Security Act (the Act), the Centers for Medicare & Medicaid Services (CMS) has the authority to add coverage of “additional preventive services” through the Medicare national coverage determination (NCD) process if certain statutory requirements are met: (1) reasonable and necessary for the prevention or early detection of illness or disability, (2) recommended with a grade of A or B by the United States Preventive Services Task Force (USPSTF), and (3) appropriate for individuals entitled to benefits under Part A or enrolled under Part B.

Jan. 13, 2015

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.

H3811_MA4001_2019A, Page updated 10/1/2018