(Medicare National Coverage Determinations Manual)

Use of the CBGCD is covered for short -term management of insulin dependent diabetics in crisis situations, in a hospital inpatient setting, and only under the direction of specially trained medical personnel.   40.4 - Insulin Syringe  (Rev. 1, 10- 03-03) CIM 45 -3  Medical supplies are covered under 1861(s)(2)(A)  of the Act only when they are furnished incident to a physicians profes sional 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), Puls atile Intravenous Insulin Treatment (PIVIT), Pulse Insulin Therapy (PIT), and Pulsatile Therapy (PT).   In OIVIT, insulin is intravenously administered in the outpatient setting for a variety of indications. Most commonly, it is delivered in pulses, but it may be delivered as a more conventional drip solution. The insulin administration is adjunctive to the patients routine diabetic management regimen (oral agent or insulin- based) or other disease management regimen, typically performed on an intermittent basis (often weekly), and frequently performed chronically without duration limits. Glucose or other carbohydrate is available ad libitum (in accordance with patient desire).   B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   Effective for claims with dates of service on and after December 23, 2009, the Centers for Medicare and Medicaid Services (CMS) determines that the evidence does not support a conclusion that OIVIT improves health outcomes in Medicare beneficiaries. Therefor e, 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 det erminations, 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 def initions.   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 consisti ng 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 formu lation 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 sever e speech impairment and is primarily used for the purpose of generating speech, it is not necessary for the device to be dedicated only to audible/verbal speech output to be considered DME.  Computers and tablets are generally not considered DME because they are useful in the absence of an illness or injury.  B. Nationally Covered Indications   N/A  C. Nationally Non -Covered Indications   Internet or phone services or any modification to a patients home to allow use of the speech generating device are not covered by Medicare because such services or modifications could be used for non- medical equipment such as standard phones or personal c omputers.  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 softw are 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 Advanc e Beneficiary Notice (ABN), or similar notice, which informs that these features are not covered and to alert the beneficiary of the expense of these features.   D. Other  A/B MACs acting within their respective jurisdictions have discretion to cover or not cover speech generating devices based on their individual reasonable and necessary determinations.   (This NCD last reviewed July 2015.)   50.2 - Electronic Speech Aids  (Rev. 1, 10- 03-03) CIM 65 -5  Electronic speech aids are covered under Part B as prosthetic devices when the patient has had a laryngectomy or his larynx is permanently inoperative.  There are two types of speech aids.  One operates by placing a vibrating head against the throat; the other amplifies sound waves through a tube which is inserted into the users mouth.  A patient who has had radical neck surgery and/or extensive radiation to the anterior part of the neck would generally be able to use only the oral tube model or one of the more sensitive and more expensive throat contact devices.   Cross -reference:   The Medicare Benefit Policy Manual, Chapter 15, Covered Medical and Other Health Services, 120.     50.3 - Cochlear Implantation (Effective April 4, 2005)  (Rev. 11875; Issued:02- 23-23; Effective: 09 -26-22; Implementation: 03 -24-23)  A.   General   A cochlear implant device is an electronic instrument, part of which is implanted surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the individual to capture, analyze, and code s ound. 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 imp lantation listed  in Section B  are deemed not eligible for Medicare coverage except as described in Section D below.   D.    Other    CMS may provide coverage of cochlear implants for beneficiaries not meeting the coverage criteria listed in Section B when performed in the context of FDA -approved category B investigational device exemption clinical trials as defined at 42 CFR 405.201 or as a routine cost in clinical trials under section 310.1 of the National Coverage Determinations Manual titled Routine Costs in Clinical Trials.   (This NCD last reviewed September 2022)    50.4 - Tracheostomy Speaking Valve  (Rev. 1, 10- 03-03) CIM 65 -16  A trachea tube has been determined to satisfy the definition of a prosthetic device, and the tracheostomy speaking valve is an add on to the trachea tube which may be considered a medically necessary accessory that enhances the function of the tube.  In other words, it makes the system a better prosthesis.  As such, a tracheostomy speaking valve is covered as an element of the trachea tube which makes the tube more effective.   50.5 - Oxygen Treatment of Inner Ear/Carbon Therapy  (Rev. 1, 10- 03-03) CIM 35 -29  Not Covered   Oxygen (95 percent) and carbon dioxide (5 percent) inhalation therapy for inner ear disease, such as endolymphatic hydrops and fluctuant hearing loss, is not reasonable and necessary.  The therapeutic benefit deriving from this procedure is highly questionable.   50.6 - Tinnitus Masking (RETIRED)  (Rev. 11892; Issued: 03- 09-23; Effective: 04 -10-23; Implementation:04- 10-23)    This section of the NCD Manual was retired December 18, 2014.   50.7 - Cochleostomy With Neurovascular Transplant for Menieres Disease  (Rev. 1, 10- 03-03) CIM 35 -50  Not Covered   Menieres disease (or syndrome) is a common cause of paroxysmal vertigo.  Menieres syndrome is usually treated medically.  When medical treatment fails, surgical treatment may be required.