Persius/hicric huggingface dataset:
**Abstract:**  
  
Corneal Pachymetry is the measurement of corneal thickness and commonly uses
either ultrasonic or optical methods. Measurement of corneal thickness in
individuals presenting with increased intraocular pressure assists in
determining if there is a risk of glaucoma or if the individual's increased
eye pressure is the result of abnormal corneal thickness. The test must be
integral to the medical management decision-making of the patient. Coverage is
limited to ophthalmologists and optometrists.  
  
**Indications and Limitations:**  
  
Medicare will consider corneal pachymetry to be medically necessary and
reasonable when performed to determine the amount of endothelial trauma
sustained during surgery, assessment of the health of the cornea pre-
operatively in Fuch's dystrophy, post ocular trauma and for the assessment of
corneal thickness or (in suspected glaucoma) following the diagnosis of
increased intraocular pressure prior to the initiation of a treatment regimen
for glaucoma. It is expected that services for the measurement of corneal
thickness following the diagnosis of increased intraocular pressure will be
performed once in a lifetime, unless there has been interval corneal trauma or
surgery.  
  
Medicare will consider corneal pachymetry to be medically necessary and
reasonable when performed only by ophthalmologist and optometrists.  
  
Medicare will not pay for use of pachymetry when used in preparation for
surgery to reshape the cornea of the eye for the purpose of correcting visual
problems (refractive surgery), such as myopia (nearsightedness) and hyperopia
(farsightedness).  
  
Whether patients have been previously diagnosed and are under treatment for
glaucoma or are newly diagnosed, pachymetry will be covered once per lifetime,
or more frequently in cases where there has been surgical or non-surgical
trauma.  
  
When there is a question of corneal disease supported by diagnosis, then
pachymetry may be performed at the same time as endothelial cell count.
**History/Background and/or General Information**

Transesophageal Echocardiography (TEE) is a cardiac diagnostic procedure in
which a modified endoscope, with an ultrasound transducer, is passed into the
esophagus and/or stomach in order to obtain 2-D/3D echo images and spectral
and color Doppler information about the heart and its great vessels.  
  
Transesophageal Echocardiography (TEE) imaging is a viable alternative when
transthoracic imaging is problematic or difficult. In many instances,
abnormalities can be displayed that are missed with standard diagnostic
techniques, and the images displayed are often of superior quality because of
the high-resolution probes that can be used.

**Covered Indications**

Transesophageal echocardiogram will be considered medically necessary in any
of the following circumstances:

  * Examination of prosthetic heart valves, primarily mitral
  * Arrhythmias - assessment of patients with certain cardiac arrhythmias [atrial fibrillation, atrial flutter] for which the results of the test will influence treatment decisions. TEE may complement transthoracic echocardiography particularly to assess for left atrial thrombus.
  * Detection of: 
    * aortic dissection
    * atrial septal defect
    * congenital heart disease
    * embolism or thrombosis, primarily involving left atrium
    * intracardiac foreign bodies, tumors or masses
    * mitral valve regurgitation
    * vegetative endocarditis
  * Intra-operative guide to left ventricular function
  * Inadequacy of transthoracic echo due to: 
    * chest wall deformity, COPD
    * open heart or chest surgery
    * chest trauma
    * obesity

**Limitations**

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.
**History/Background and/or General Information**

Computerized Corneal Topography (also known as computer-assisted video
keratography [CAVK]) and corneal mapping is a computer assisted diagnostic
imaging technique in which a special instrument projects a series of light
rings on the cornea, creating a color coded map of the corneal surface as well
as a cross-section profile. This service is used to provide a detailed map or
chart of the physical features and shape of the anterior surface of the
cornea. This permits a more accurate portrayal of the physical state of the
cornea and the subtle detection of corneal surface irregularity and
astigmatism.

Please refer to CMS IOM Publication 100-03, _Medicare National Coverage
Determinations (NCD) Manual_ , Chapter 1, Part 1, Section 80.7 and Section
80.7.1 for guidelines regarding keratoplasty.

**Covered Indications**

Computerized Corneal Topography will be considered medically necessary under
any of the following conditions:

  * pre-operatively for evaluation of irregular astigmatism prior to cataract surgery
  * monocular diplopia
  * bullous keratopathy
  * post surgical or post traumatic astigmatism, measuring at a minimum of 3.5 diopters;
  * post penetrating keratoplasty surgery;
  * post surgical or post traumatic irregular astigmatism;
  * corneal dystrophy;
  * complications of transplanted cornea;
  * post traumatic corneal scarring;
  * keratoconus; and/or
  * pterygium and/or corneal ectasia that cause visual impairment.

**Limitations**

Corneal topography will only be allowed for a pre-operative cataract patient
if documentation supports that the patient has irregular astigmatism.

Corneal topography is to be billed only when the diagnosis of monocular
diplopia is thought to be caused by a corneal irregularity.

Corneal topography is a covered service for the above indications when
medically reasonable and necessary only if the results will assist in defining
further treatment. It is not covered for routine follow-up testing.

Repeat testing is only indicated if a change of vision is reported in
connection with one of the above listed conditions.

Services performed for screening purposes or in the absence of associated
signs, symptoms, illness or injury as indicated above, will be denied as non-
covered.

Corneal topography will be non-covered if performed pre- or post-operatively
in relation to a non-covered procedure, i.e., radial keratotomy.

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.
**Covered Indications**

Destruction of malignant skin lesions

The destruction of malignant skin lesions will be considered medically
necessary in the following circumstances:

  * When a pathology report confirms the diagnosis of a skin malignancy, and/or 
  * When the description of the lesion is consistent with that of a skin malignancy.

**Limitations**

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.
**History/Background and/or General Information**

A skin lesion is any alteration in the normal skin architecture. Lesions can
be benign, pre-malignant or malignant. The most common malignant lesions are
Basal Cell Carcinomas (BCC), Squamous Cell Carcinomas (SCC) and Melanomas.

Four of the most common methods of treatment of malignant skin lesions are:

  * Surgical excision,
  * Electrodesiccation (tissue destruction by heat),
  * Radiation therapy, or
  * Cryosurgery (tissue destruction by freezing)

**Covered Indications**

The treatment of choice for malignant skin lesions is complete excision that
includes a variable margin of surrounding tissue in order to eradicate
microscopic tumor cells, which may have spread beyond the visible borders of
the lesion.

The excision of a malignant skin lesion including margins will be considered
medically necessary when a pathology report verifies the existence of a
malignancy.

**Limitations**

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.
Please refer to CMS IOM Publication 100-02, _Medicare Benefit Policy Manual_ ,
Chapter 15, Section 290 Foot Care for indications and limitations in coverage
for treatment of mycotic nails.

**Covered Indications**

Medicare will consider the treatment of fungal (mycotic) infection of the
nails a covered service when the medical record substantiates:

  * Clinical evidence of mycosis of the nail, by generally accepted clinical findings such as discoloration, onycholysis, subungual debris, thickening, or secondary skin infection;

In addition one of the following must be documented for mycotic toenails:

  * the ambulatory patient has marked limitation of ambulation, pain, or secondary infection resulting from the thickening and dystrophy of the infected toenail plate(s); or
  * the non-ambulatory patient suffers from pain or secondary infection resulting from the thickening and dystrophy of the infected toenail plate(s).

Appropriate anti-fungal treatment is necessary to qualify nail debridement as
a medically necessary and reimbursable service unless contraindicated. If an
anti-fungal treatment is not used, the contraindication must be documented in
the medical record.

Patients need not have an underlying systemic condition to be covered for
mycotic nail care.

**Limitations**

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.
**History/Background and/or General Information**

Pulse oximetry provides a simple, accurate, and noninvasive technique for the
continuous or intermittent monitoring of arterial oxygen saturation. A small
lightweight device attaches to the finger or toe and directs through the
nailbed two wavelengths of light; a photodetector measures absorption.
Arterial pulsation is used to gate the signal to the arterial component of
blood contained within the nailbed.

Ear oximetry is a noninvasive method for evaluating arterial oxygenation. Ear
oximeters are commonly used in sleep studies.

**Covered Indications**

**Single and Multiple Determinations of oxygen saturation:**

Ear or pulse oximetry for oxygen saturation will be considered medically
necessary when the patient has a condition resulting in hypoxemia and there is
a need to assess the status of a chronic respiratory condition, supplemental
oxygen requirements and/or a therapeutic regimen.  
  
 **Continuous Overnight Monitoring of oxygen saturation:**

Ear or pulse oximetry for oxygen saturation by continuous overnight monitoring
will be considered medically necessary in the following circumstances:

  * The patient must have a condition for which intermittent arterial blood gas sampling is likely to miss important variations, and
  * The patient must have a condition resulting in hypoxemia and there is a need to assess supplemental oxygen requirements and/or a therapeutic regimen.

**Limitations**

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.
Please refer to CMS IOM Publication 100-02, _Medicare Benefit Policy Manual_ ,
Chapter 15, Section 290 Foot Care for indications and limitations in coverage
of routine foot care.

**Covered Indications**

Routine foot care may be available for patients with peripheral neuropathy
involving the feet, but without vascular impairment. The neuropathy should be
of such severity that care by a non- professional person would put the patient
at risk. The medical record must document the patient has an absence of
sensation at two or more sites out of five tested on either foot when tested
with the 5.07 Semmes-Weinstein monofilament to support the diagnosis of
peripheral neuropathy with loss of protective sensation. This testing may be
performed by the attending physician, non-physician practitioner, or the
podiatrist.

For patients requiring anticoagulation therapy, the provider must document in
the medical record the significant risk and danger posed by the non-
professional rendering routine foot care services.

**Limitations**

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.
Compliance with the provisions in this LCD may be monitored and addressed
through post payment data analysis and subsequent medical review audits.

  
**History/Background and/or General Information**

Vitamin B12 is essential for the formation of red blood cells and is used in
the treatment of diseases in which there is defective red cell formation.

  
**Covered Indications**

Vitamin B12 injection will be considered medically reasonable and necessary
under the following circumstances:

  * Vitamin B12 administration by injection is a covered benefit accepted as medically necessary when the beneficiary has a history of a low serum B12 or conditions causing or caused by a low serum B12. 

In addition, vitamin B12 will be considered medically reasonable and necessary
when administered as an adjunct to pemetrexed or pralatrexate treatment as
follows:

  * For pemetrexed patients, patients must receive one intramuscular injection of vitamin B12 during the week preceding the first dose of pemetrexed and every three cycles thereafter
  * For pralatrexate patients, supplement patients with vitamin B12 1 mg intramuscularly no more than 10 weeks prior to the first dose of pralatrexate, and every 8-10 weeks thereafter

Subsequent vitamin B12 injections may be given the same day as either
pemetrexed or pralatrexate.

  
**Limitations**

Please refer to CMS IOM Publication 100-03, _Medicare National Coverage
Determinations (NCD) Manual_ , Chapter 1, Part 2, Section 150.6 Vitamin B12
Injections to Strengthen Tendons, Ligaments, etc., of the Foot regarding non
coverage.

  
**Notice:** Services performed for any given diagnosis must meet all of the
indications and limitations stated in this LCD, the general requirements for
medical necessity as stated in CMS payment policy manuals, any and all
existing CMS national coverage determinations, and all Medicare payment rules.
**History/Background and/or General Information**

Aerosol or vapor inhalation involves the administration of drugs or solution
of drugs by the nasal or oral respiratory route for local or systemic effect.
The drugs or solution of drugs commonly administered via a nebulizer or
aerosol include distilled water, hypertonic saline, and bronchodilators such
as anticholinergics and B-Agonists.

Inhalation therapy is used in the therapeutic treatment of patients with known
lung disease, as well as for producing bronchodilation, mobilizing sputum, and
inducing sputum production for diagnostic purposes.

This policy addresses the use of aerosol or vapor inhalation for sputum
mobilization, bronchodilation, and sputum induction for diagnostic purposes.

If a patient is unable to produce sputum, inhalation of a nebulized solution
of 3 or 4 ml of distilled water or hypertonic sodium chloride results in the
induction of an adequate specimen for examination. Any type of nebulizer may
be used; however, ultrasonic nebulizers, which produce a concentrated mist,
are preferred. The procedure is terminated when an adequate specimen is
obtained, the nebulizer solution is exhausted, or after a maximum of 15-20
minutes. The procedure is most often used for patients suspected of having
tuberculosis or a lung malignancy, and to search for Pneumocystis carinii
infection in patients with the acquired immunodeficiency syndrome (AIDS).

**Covered Indications**

The use of an aerosol or vapor inhalation for diagnostic purposes will be
considered medically reasonable and necessary for the following indications:

  * For the induction/mobilization of sputum in a patient who presents with signs and symptoms of a respiratory infection (e.g., fever, dyspnea, chest congestion, cough) or suspected lung malignancy, and who is unable to produce an adequate sputum specimen for examination by conventional methods;
  * For the induction/mobilization of sputum in a patient who continues to demonstrate signs and symptoms of a respiratory infection (e.g., fever, dyspnea, chest congestion, cough) despite antibiotic treatment, and who is unable to produce an adequate sputum specimen for follow-up examination by conventional methods; and/or
  * To produce bronchodilation prior to a pulmonary function test (PFT), when the patient's functional ability to perform the test is decreased and would otherwise result in an inconclusive finding.

**Limitations**

As published in the CMS IOM Publication 100-08, _Medicare Program Integrity
Manual_ , Chapter 13, Section 13.5.4, an item or service may be covered by a
contractor LCD if it is reasonable and necessary under the Social Security Act
Section 1862 (a)(1)(A). Contractors shall determine and describe the
circumstances under which the item or service is considered reasonable and
necessary.
This policy applies to the following: seborrheic keratoses, skin tags, milia,
molluscum contagiosum, sebaceous (epidermoid) cysts, moles (nevi), acquired
hyperkeratosis (keratoderma) and viral warts (excluding condyloma acuminatum).
The treatment of actinic keratosis is covered by NCD 250.4. This policy does
not address routine foot care or the treatment of other skin lesions, e.g.,
ulcers, abscess, malignancies, dermatoses or psoriasis.  
  
Benign skin lesions are common in the elderly and are frequently removed at
the patient's request to improve appearance. Removal of benign skin lesions
that do not pose a threat to health or function is considered cosmetic and as
such is not covered by the Medicare program. Cosmesis is statutorily non-
covered and no payment may be made for such lesion removal.  
  
Medicare will consider the removal of benign skin lesions as medically
necessary, and not cosmetic, if one or more of the following conditions is
present and clearly documented in the medical record:  
  
A. The lesion has one or more of the following characteristics:  
1\. bleeding  
2\. intense itching  
3\. pain  
  
B. The lesion has physical evidence of inflammation, e.g., purulence, oozing,
edema, erythema.  
  
C. The lesion obstructs an orifice or clinically restricts vision.  
  
D. The clinical diagnosis is uncertain, particularly where malignancy is a
realistic consideration based on lesional appearance (e.g. non-response to
conventional treatment, or change in appearance). **However, if the diagnosis
is uncertain, either biopsy or removal may be more prudent than destruction.**  
  
E. A prior biopsy suggests or is indicative of lesion malignancy or
premalignancy.  
  
F. The lesion is in an anatomical region subject to recurrent physical trauma
and there is documentation that such trauma has in fact occurred.  
  
G. Wart removals will be covered under (a) through (f) above. In addition,
wart destruction will be covered when the following clinical circumstance is
present:  
  

    * Periocular warts associated with chronic recurrent conjunctivitis thought secondary to lesional virus shedding
    * Evidence of spread from one body area to another, particularly in immunocompromised/immunosuppressed patients.

  
If the beneficiary wishes one or more benign asymptomatic lesions removed for
cosmetic purposes, the beneficiary becomes liable for the service(s) rendered.  
  
 **Regarding other Malignancy:**  
If a diagnosis of malignancy has already been established for a specific
lesion, a shave biopsy would not be medically reasonable and necessary.  
  
Compliance with the provisions in this policy may be subject to monitoring by
post payment data analysis and subsequent medical review.