Persius/hicric huggingface dataset:
**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 _re_ cognition. _P_ atients _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)_
**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..

_
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.
Urinary collection and retention system are covered as prosthetic devices that
replace bladder function in the case of permanent urinary incontinence. There
is insufficient evidence to support the medical necessity of a single use
system bag rather than the multi-use bag. Therefore, a single use drainage
system is subject to the same coverage parameters as the multi-use drainage
bags.
Effective January 1, 2002, sacral nerve stimulation is covered for the
treatment of urinary urge incontinence, urgency-frequency syndrome, and
urinary retention. Sacral nerve stimulation involves both a temporary test
stimulation to determine if an implantable stimulator would be effective and a
permanent implantation in appropriate candidates. Both the test and the
permanent implantation are covered.

The following limitations for coverage apply to all three indications:

  * Patient must be refractory to conventional therapy (documented behavioral, pharmacologic and/or surgical corrective therapy) and be an appropriate surgical candidate such that implantation with anesthesia can occur.
  * Patients with stress incontinence, urinary obstruction, and specific neurologic diseases (e.g., diabetes with peripheral nerve involvement) which are associated with secondary manifestations of the above three indications are excluded.
  * Patient must have had a successful test stimulation in order to support subsequent implantation. Before a patient is eligible for permanent implantation, he/she must demonstrate a 50% or greater improvement through test stimulation. Improvement is measured through voiding diaries.
  * Patient must be able to demonstrate adequate ability to record voiding diary data such that clinical results of the implant procedure can be properly evaluated.
While the Act does not specifically identify patient education programs as
covered services, reimbursement may be made under Medicare for such programs
furnished by providers of services (i.e., hospitals, SNFs, HHAs, and OPT
providers) to the extent that the programs are appropriate, integral parts in
the rendition of covered services which are reasonable and necessary for the
treatment of the individual's illness or injury. For example, educational
activities carried out by nurses such as teaching patients to give themselves
injections, follow prescribed diets, administer colostomy care, administer
medical gases, and carry out other inpatient care activities may be
reimbursable as a part of covered routine nursing care. Also, the teaching by
an occupational therapist of compensatory techniques to improve a patient's
level of independence in the activities of daily living may be reimbursed as a
part of covered occupational therapy. Similarly, the instruction of a patient
in the carrying out of a maintenance program designed for him/her by a
physical therapist may be reimbursed as part of covered physical therapy.

However, when the educational activities are not closely related to the care
and treatment of the patient, such as programs directed toward instructing
patients or the public generally in preventive health care activities,
reimbursement cannot be made since the Act limits Medicare payment to covered
care which is reasonable and necessary for the treatment of an illness or
injury. For example, programs designed to prevent illness by instructing the
general public in the importance of good nutritional habits, exercise
regimens, and good hygiene are not reimbursable under Medicare.
Please refer to [42 CFR 410.140 - 410.146](https://www.ecfr.gov/cgi-bin/text-
idx?node=sp42.2.410.h&rgn=div6#se42.2.410_1141) for conditions that must be
met for Medicare coverage.
Human tumor drug sensitivity assays are considered experimental, and
therefore, not covered under Medicare at this time.

The clinical application of the assay, based on testing in tumor microorgans
rather than in clones derived from single cells, is considered experimental,
and therefore, not covered under Medicare at this time.
Medicare Administrative Contractors should be alert to possible increases in
utilization of DSA over conventional angiographic procedures, as well as to
the fact that ordinarily patients should not require inpatient hospitalization
solely to perform the procedure.

Payment for DSA should not exceed, and may be less than, that being paid for
conventional angiographic techniques.
Conditions for coverage of bone mass measurements are now contained in
[chapter 15, section 80.5 of Pub. 100-02, Medicare Benefit Policy
Manual](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Transmittals/Downloads/R70BP.pdf). Claims processing
instructions can be found in [chapter 13, section 140 of Pub. 100-04, Medicare
Claims Processing Manual](https://www.cms.gov/Regulations-and-
Guidance/Guidance/Transmittals/Downloads/R1236CP.pdf).
It is a covered test under Medicare when it is medically necessary to assess
lymphocytic function in diagnosed immunodeficiency diseases and to monitor
immunotherapy.

It is not covered when it is used to monitor the treatment of cancer, because
its use for that purpose is experimental.
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.
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.
The use of the portable hand-held X-ray instrument as an imaging device is
covered under Medicare. It should be reimbursed as part of the physician's
professional service, and no additional charge should be allowed.
It is a covered service when used in assessing visual fields in patients with
glaucoma or other neuropathologic defects.
**

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.
The Following Breath Test is Covered:

  * Lactose breath hydrogen to detect lactose malabsorption.

The Following Breath Tests are Excluded from Coverage:

  * Lactulose breath hydrogen for diagnosing small bowel bacterial overgrowth and measuring small bowel transit time.
  * CO2 for diagnosing bile acid malabsorption.
  * CO2 for diagnosing fat malabsorption.
These tests may be covered when performed to help determine a diagnosis for
symptomatic patients. They are not covered when furnished as part of a
screening program for asymptomatic persons.

**NOTE** : Two enzyme-linked immunosorbent assay (ELISA) tests that were
conducted on the same specimen must both be positive before Medicare will
cover the Western blot test.
Effective October 31, 1988, sublingual intracutaneous and subcutaneous
provocative and neutralization testing and neutralization therapy for food
allergies are excluded from Medicare coverage because available evidence does
not show that these tests and therapies are effective. This exclusion was
published as a Final Notice in the "Federal Register" on September 29, 1988.
**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:

  1. With proven or suspected disease involving severe regurgitation of the aorta;
  2. With minute ventilation (MV) sensor function pacemakers, since the device may adversely affect the functioning of that type of pacemaker;
  3. During cardiac bypass surgery; or,
  4. 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

**

Medicare Administrative Contractors 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.
**CIM 50-55**

Covered

**A. General**

Section 4103 of the Balanced Budget Act of 1997 provides for coverage of
certain prostate cancer screening tests subject to certain coverage,
frequency, and payment limitations. Medicare will cover prostate cancer
screening tests/procedures for the early detection of prostate cancer.
Coverage of prostate cancer screening tests includes the following procedures
furnished to an individual for the early detection of prostate cancer:

  * Screening digital rectal examination; and
  * Screening prostate specific antigen blood test

**B. Screening Digital Rectal Examinations**

Screening digital rectal examinations are covered at a frequency of once every
12 months for men who have attained age 50 (at least 11 months have passed
following the month in which the last Medicare-covered screening digital
rectal examination was performed). Screening digital rectal examination means
a clinical examination of an individual's prostate for nodules or other
abnormalities of the prostate. This screening must be performed by a doctor of
medicine or osteopathy (as defined in 1861(r)(1) of the Act), or by a
physician assistant, nurse practitioner, clinical nurse specialist, or
certified nurse midwife (as defined in 1861(aa) and 1861(gg) of the Act) who
is authorized under State law to perform the examination, fully knowledgeable
about the beneficiary's medical condition, and would be responsible for using
the results of any examination performed in the overall management of the
beneficiary's specific medical problem.

**C. Screening Prostate Specific Antigen Tests**

Screening prostate specific antigen tests are covered at a frequency of once
every 12 months for men who have attained age 50 (at least 11 months have
passed following the month in which the last Medicare-covered screening
prostate specific antigen test was performed). Screening prostate specific
antigen tests (PSA) means a test to detect the marker for adenocarcinoma of
prostate. PSA is a reliable immunocytochemical marker for primary and
metastatic adenocarcinoma of prostate. This screening must be ordered by the
beneficiary's physician or by the beneficiary's physician assistant, nurse
practitioner, clinical nurse specialist, or certified nurse midwife (the term
"attending physician" is defined in 1861(r)(1) of the Act to mean a doctor of
medicine or osteopathy and the terms "physician assistant, nurse practitioner,
clinical nurse specialist, or certified nurse midwife" are defined in
1861(aa) and 1861(gg) of the Act) who is fully knowledgeable about the
beneficiary's medical condition, and who would be responsible for using the
results of any examination (test) performed in the overall management of the
beneficiary's specific medical problem.
**B. Nationally Covered Indications**

Not applicable.

**C. Nationally Noncovered Indications**

All uses of sNCT to diagnose sensory neuropathies or radiculopathies are
noncovered.

(This NCD last reviewed June 2004.)
Frequency limitations: Medicare Administrative Contractor discretion.

In the case of myocardial viability, FDG positron emission tomography (PET)
may be used following a SPECT that was found to be inconclusive. However,
SPECT may not be used following an inconclusive FDG PET performed to evaluate
myocardial viability.
**

A. Non-Palpable Breast Lesions

**

Effective January 1, 2003, Medicare covers percutaneous image-guided breast
biopsy using stereotactic or ultrasound imaging for a radiographic abnormality
that is non-palpable and is graded as a BIRADS III, IV, or V.

**

B. Palpable Breast Lesions

**

Effective January 1, 2003, Medicare covers percutaneous image guided breast
biopsy using stereotactic or ultrasound imaging for palpable lesions that are
difficult to biopsy using palpation alone. Medicare Administrative Contractors
have the discretion to decide what types of palpable lesions are difficult to
biopsy using palpation.
**280.13 - Transcutaneous Electrical Nerve Stimulators (TENS) (RETIRED)  
(Rev. 11892; Issued: 03-09-23; Effective: 04-10-23; Implementation: 04-10-23)

Please note section 280.13 has been removed from the NCD Manual and
incorporated into NCD 160.27 _effective June 8, 2012._
The clinical effectiveness of the multiple-seizure electroconvulsive therapy
has not been verified by scientifically controlled studies. In addition,
studies have demonstrated an increased risk of adverse effects with multiple
seizures. Accordingly, MECT cannot be considered reasonable and necessary and
is not covered by the Medicare program.
**B. Nationally Covered Indications**

Effective for services performed on or after April 1, 2001, this procedure is
covered only when performed for patients who have failed total parenteral
nutrition (TPN) and only when performed in centers that meet approval
criteria.

1\. Failed TPN

The TPN delivers nutrients intravenously, avoiding the need for absorption
through the small bowel. TPN failure includes the following:

  * Impending or overt liver failure due to TPN induced liver injury. The clinical manifestations include elevated serum bilirubin and/or liver enzymes, splenomegaly, thrombocytopenia, gastroesophageal varices, coagulopathy, stomal bleeding or hepatic fibrosis/cirrhosis.
  * Thrombosis of the major central venous channels; jugular, subclavian, and femoral veins. Thrombosis of two or more of these vessels is considered a life threatening complication and failure of TPN therapy. The sequelae of central venous thrombosis are lack of access for TPN infusion, fatal sepsis due to infected thrombi, pulmonary embolism, Superior Vena Cava syndrome, or chronic venous insufficiency.
  * Frequent line infection and sepsis. The development of two or more episodes of systemic sepsis secondary to line infection per year that requires hospitalization indicates failure of TPN therapy. A single episode of line related fungemia, septic shock and/or Acute Respiratory Distress Syndrome are considered indicators of TPN failure.
  * Frequent episodes of severe dehydration despite intravenous fluid supplement in addition to TPN. Under certain medical conditions such as secretory diarrhea and non-constructable gastrointestinal tract, the loss of the gastrointestinal and pancreatobiliary secretions exceeds the maximum intravenous infusion rates that can be tolerated by the cardiopulmonary system. Frequent episodes of dehydration are deleterious to all body organs particularly kidneys and the central nervous system with the development of multiple kidney stones, renal failure, and permanent brain damage.

2\. Approved Transplant Facilities

Intestinal transplantation is covered by Medicare if performed in an approved
facility. The criteria for approval of centers will be based on a volume of 10
intestinal transplants per year with a 1-year actuarial survival of 65 percent
using the Kaplan-Meier technique.

**C. Nationally Non-covered Indications**

All other indications remain non-covered.

**D. Other**

NA. This NCD last reviewed May 2006.
**A. Nationally Covered Indications**

Not applicable.

**B. Nationally Noncovered Indications**

The clinical effectiveness of arthroscopic lavage and arthroscopic debridement
for the severe osteoarthritic knee has not been verified by scientifically
controlled studies. After thorough discussions with clinical investigators,
the orthopedic community, and other interested parties, CMS determines that
the following procedures are not considered reasonable or necessary in
treatment of the osteoarthritic knee and are not covered by the Medicare
program:

  * Arthroscopic lavage used alone for the osteoarthritic knee;
  * Arthroscopic debridement for osteoarthritic patients presenting with knee pain only; or,
  * Arthroscopic debridement and lavage with or without debridement for patients presenting with severe osteoarthritis (Severe osteoarthritis is defined in the Outerbridge classification scale, grades III and IV. Outerbridge is the most commonly used clinical scale that classifies the severity of joint degeneration of the knee by compartments and grades. Grade I is defined as softening or blistering of joint cartilage. Grade II is defined as fragmentation or fissuring in an area <1 cm. Grade III presents clinically with cartilage fragmentation or fissuring in an area >1 cm. Grade IV refers to cartilage erosion down to the bone. Grades III and IV are characteristic of severe osteoarthritis.)

**C. Other**

Apart from the noncovered indications above for arthroscopic lavage and/or
arthroscopic debridement of the osteoarthritic knee, all other indications of
debridement for the subpopulation of patients without severe osteoarthritis of
the knee who present with symptoms other than pain alone; i.e., (1) mechanical
symptoms that include, but are not limited to, locking, snapping, or popping
(2) limb and knee joint alignment, and (3) less severe and/or early
degenerative arthritis, remain at local contractor discretion. Medicare
contractors may require submission of one or all of the following documents to
define the patient's knee condition:

  * Operative notes,
  * Reports of standing x-rays, or,
  * Arthroscopy results.

(This NCD last reviewed June 2004.)
**

B. Nationally Covered Indications

**

Medicare will pay for the routine costs, as well as transplantation and
appropriate related items and services, for Medicare beneficiaries
participating in a National Institutes of Health (NIH)-sponsored clinical
trial(s). The term 'routine costs' means reasonable and necessary routine
patient care costs, including immunosuppressive drugs and other follow-up
care, as defined in section [310.1](https://www.cms.gov/medicare-coverage-
database/details/ncd-
details.aspx?NCDId=1&ncdver=2&DocID=310.1&SearchType=Advanced&bc=EAAAAAgAAAAA&)
of the NCD Manual.

Specifically, Medicare will cover transplantation of pancreatic islet cells,
the insulin producing cells of the pancreas. Coverage will include the costs
of acquisition and delivery of the pancreatic islet cells, as well as
clinically necessary inpatient and outpatient medical care and
immunosuppressants.

**

C. Nationally Noncovered Indications

**

Partial pancreatic tissue transplantation or islet cell transplantation
performed outside the context of a clinical trial continues to be noncovered.

**

D. Other

**

Not applicable.

(This NCD last reviewed July 2004.)
**220.2.1 - Magnetic Resonance Spectroscopy (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 Magnetic Resonance Spectroscopy. In the absence of an NCD,
coverage determinations will be made by the Medicare Administrative
Contractors under section 1862(a)(1)(A) of the Social Security Act.