CPT for Sublingual Immunotherapy as a Technique of Allergen- Specific Therapy 95199


Code Description CPT

95199 Unlisted allergy/clinical immunologic service or procedure


Sublingual Immunotherapy as a Technique of Allergen- Specific Therapy

Introduction

Treating allergies often involves giving the person small doses of what they are allergic to. This tends to increase a person’s immunity, or tolerance, to the substance. These substances are often given by injections (shots). But a newer method is to put the substance in drops and give them under the tongue. This is called sublingual (which means under the tongue) immunotherapy. This treatment is also sometimes called allergy drops. This policy explains when sublingual immunotherapy is medically necessary.

Policy Coverage Criteria

Sublingual Immunotherapy Medical Necessity

* Oralair®
* Grastek®
* Ragwitek®

Sublingual immunotherapy using Oralair®, Grastek®, or Ragwitek® may be considered medically necessary, when used according to U. S. Food and Drug Administration labeling, for the treatment of pollen-induced allergic rhinitis when the following conditions are met:

* Patient has a history of rhinitis or rhinoconjunctivitis symptoms related to grass or short ragweed pollen exposure

* Patient has a documented positive pollen-specific skin test or pollen-specific immunoglobulin E test.

o Allergy must be confirmed by positive skin test or in vitro testing for pollen-specific immunoglobulin E antibodies to the species contained in the product or, for Grastek®, Timothy grass pollen extract, to cross-reactive species.

* Patient’s symptoms are not adequately controlled by appropriate pharmacotherapy (see Related Information). Sublingual immunotherapy as a technique of allergy immunotherapy is considered investigational for all other uses.




Use of Oralair®, Grastek®, and Ragwitek®

Contraindications


Contraindications include severe, unstable or uncontrolled asthma; history of any severe reactions (local or systemic) to sublingual or other immunotherapy; or a history of eosinophilic esophagitis.

Administration and Dose

* Prescribing information includes a black box warning for severe allergic reactions including anaphylaxis and severe laryngopharyngeal edema. Patients must be prescribed an epinephrine auto-injector and be trained on how to use it.

* Oralair® is approved by the Food and Drug Administration (FDA) for patients 10 to 65 years of age. Grastek® has been FDA-approved for patients 5 to 65 years of age. Ragwitek® has been FDA-approved for patients 18 to 65 years of age.

* Treatment should begin 12 weeks (16 weeks for Oralair®) before the expected onset of the allergy-inducing pollen season. Each product is dosed once daily and continued throughout the pollen season (precoseasonal dosing).

* The first dose is administered under the supervision of a physician experienced in diagnosing and treating severe allergic reactions. Subsequent doses may be taken at home.

* For Oralair®, dose titration is required in patients 10 to 17 years of age. Titration can be completed over 3 days at home, 100 IR [index of reactivity] on day 1, 2 times 100 IR on day 2, and 3 times 100 IR on day 3. In patients between 18 and 65 years, no dose titration is needed; treatment is initiated at the maintenance dose of 300 IR.

* Grastek® and Ragwitek® both are initiated at the maintenance dose (2800 bioequivalent allergy unit and 12 Amb a 1 unit, respectively). Pharmacotherapy of Pollen-Induced Allergic Rhinitis

There is general agreement from clinical practice guidelines on the pharmacologic treatment of pollen-induced allergic rhinitis or rhinoconjunctivitis:

* Treatment should be individualized based on symptom severity and duration, comorbidities, patient age, preference (eg, route of administration, tolerance for adverse effects), and previous treatment history

* Measures to increase treatment adherence (eg, shared decision making, consideration of the patient’s school or work schedule, use of a medication calendar or check-off list) are encouraged

* Goals of treatment are symptom reduction and improvements in functional capacity and quality of life

* A “step-up” (if treatment is inadequate) or “step-down” (if symptom relief is achieved with other interventions, eg, avoidance) approach to treatment is recommended

* Allergen avoidance is the first step of treatment but may be unrealistic for some patients Six medication classes are used to treat allergic rhinitis:
1. H1-antihistamines (oral and intranasal)
2. Corticosteroids (oral [short-course for severe disease] and intranasal)
3. Leukotriene receptor antagonists (oral)
4. Sympathomimetic decongestants (oral and intranasal)
5. Chromones (intranasal)
6. Anticholinergic, ipratropium bromide (intranasal)

o Treatment should be symptom-specific, eg, oral antihistamines may be less effective for prominent congestion than other treatments; prominent rhinorrhea may respond to intranasal ipratropium; rhinitis-only symptoms may be treated with local (intranasal) rather than systemic (oral) therapy
o For mild or intermittent symptoms, oral or nasal antihistamine may be considered firstline treatment
o Newer generation (selective) oral antihistamines generally are recommended over older (nonselective) antihistamines. Patients with insomnia and pregnant women may prefer older antihistamines because of their sedating effects and longer safety history, respectively
o Intranasal corticosteroids may be effective for more severe or persistent symptoms
o Combination treatment (eg, oral antihistamine plus intranasal corticosteroid, intranasal antihistamine and corticosteroid, antihistamine [oral or intranasal] plus sympathomimetic [oral or short-course (=5 days to avoid rebound congestion) intranasal]) may be effective for symptoms nonresponsive to single medications
o Oral sympathomimetics may cause insomnia; their use is limited in patients with certain comorbidities (eg, diabetes mellitus, unstable hypertension)
o Oral leukotriene receptor antagonists may reduce asthma exacerbations in patients with comorbid asthma

Consideration of Age

The ages stated in this policy for which Grastek®, Ragwitek®, and Oralair®, are considered medically necessary is based on the ages approved in the FDA labeling.

Benefit Application

Sublingual immunotherapy may be offered by specialized clinics.

Evidence Review Background


Sublingual immunotherapy (SLIT) is a potential alternative to subcutaneous immunotherapy (SCIT) for providing allergen-specific therapy. SLIT is proposed as a more convenient alternative delivery route for treating a variety of allergic disorders.

Allergen-specific immunotherapy involves administering well-characterized allergen extracts, the potencies of which are measured and compared with a reference standard. An initial induction or build-up phase progressively increases the allergen dose; this is followed by multiple years of maintenance injections at the highest dose. Allergen-specific immunotherapy has been used to treat a variety of conditions including insect allergy, allergic rhinitis, and asthma. Subcutaneous immunotherapy is the standard of care. Due to the inconvenience of multiple injections, particularly in children, alternative delivery routes have been investigated; of these, sublingual immunotherapy is the most prominent. Sublingual immunotherapy targets absorption to the sublingual and buccal mucosa. Allergen preparations used for sublingual immunotherapy are held under the tongue for one to several minutes and then swallowed or spit out.

CPT 0278t, 97014, E7045,E7062, E1399, G0283, L8679 - Electrical Stimulation Devices

Coding Code Description CPT

0278T Transcutaneous electrical modulation pain reprocessing (eg, scrambler therapy), each treatment session (includes placement of electrodes)

97014 Application of modality to one or more areas; electrical stimulation, unattended HCPCS

E0745 Neuromuscular stimulator, electronic shock unit

E0762 Transcutaneous electrical joint stimulation device system, includes all accessories

E1399 Durable medical equipment, miscellaneous (Determine if an alternative HCPCS Level II or a CPT code better describes the service being reported. This code should be used only if a more specific code is unavailable.)

G0283 Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care, as part of a therapy plan of care

L8679 Implantable neurostimulator, pulse generator, any type




Introduction

When muscles can’t be used after an injury or surgery, there’s a risk that the tissue will deteriorate or waste away. This is known as disuse atrophy. Neuromuscular electrical stimulation (NMES) is a way to keep muscles active so they won’t atrophy. In NMES, an electrode — a patch attached to skin that can transmit electrical signals into the body — is placed over the muscles to be stimulated. A device then sends an electrical signal to the electrode and through the skin. The electrical signal is the same type that a nerve would send to a muscle. The muscle contracts. This contraction keeps the muscles active when they otherwise wouldn’t be. This policy describes when NMES may be considered medically necessary.


Policy Coverage Criteria

Service Medical Necessity Services eligible for reimbursement


Use of a neuromuscular electrical stimulator (NMES) via an open loop system, including but not limited to the RS 4m and RS 2m, may be considered medically necessary for disuse atrophy when the nerve supply to the muscle is intact and the patient has any of the following non-neurological causes for disuse atrophy:
* Previous casting or splinting of a limb
* Contractures due to soft tissue scarring (eg, from burn)
* Previous major knee surgery (eg, total knee replacement), when there is a failure to respond to physical therapy
* Hip replacement surgery (up until the time physical therapy begins)
A conductive garment may be needed when a member meets criteria for treatment with a neuromuscular electrical stimulation device (NMES) and has one of the following medical indications:
* The treatment site is large and using a large number of standard electrodes is impractical
* There are multiple large treatment sites on the body that make using standard electrodes impractical
* The treatment site is hard to reach using standard electrodes and lead wires
* The member has a skin sensitivity that precludes use of standard electrodes, adhesive tape or lead wires

Note: Functional neuromuscular electrical stimulators (closed loop systems) are addressed in a separate policy (see Related Medical Policies).

Service Investigational

Services not eligible for reimbursement

Neuromuscular electrical stimulators (NMES) are considered investigational for ANY other unproven indication (eg, when used for general muscle strengthening in healthy individuals, for cardiac conditioning, for the treat.


Service Investigational

Electrical sympathetic stimulation therapy devices are considered investigational.

Galvanic or high-voltage galvanic stimulation is considered investigational in the treatment of chronic pain.

Microcurrent electrical nerve stimulation (MENS) devices are considered investigational.

Pulsed electrical stimulation and pulsed electromagnetic therapy are considered investigational for any indication including, but not limited to the treatment of osteoarthritis, rheumatoid arthritis, neuropathic pain (diabetic peripheral neuropathy), post-operative or non-post-operative pain, or to treat wounds. (HCPCS E0762).

Transcutaneous electrical modulation pain reprocessing (TEMPR) (also called Scrambler therapy or Calmare® pain therapy) is considered investigational (CPT 0278T).

Documentation Requirements

The patient’s medical records submitted for review should document that medical necessity criteria are met. The record should include the following:
* For neuromuscular electrical stimulator (NMES):
o Clinical documentation showing that member has disuse atrophy (loss/decrease of muscle mass due to lack of use) where the nerve supply to the muscle is intact and the member has any of the following non-neurological reasons for disuse atrophy:
* Previous casting or splinting of a limb
* Contractures due to burn scarring or recent hip replacement surgery (up until the time physical therapy begins)
* Previous major knee surgery when there is a failure to respond to physical therapy
* For a conductive garment clinical documentation of all of the above plus documentation of one of the following medical reasons:
o The treatment site is large and using a large number of standard electrodes is impractical
o There are multiple large treatment sites on the body that make using standard electrodes impractical


Documentation Requirements

o The treatment site is hard to reach using standard electrodes and lead wires
o The member has a skin sensitivity that precludes use of standard electrodes, adhesive tape, or lead wires



Related Information Definition of Terms

Conductive garment: A form-fitted garment with integrated conductive fibers that are separated from the patient’s skin by a layer of fabric. Disuse atrophy: Gradual wasting or deterioration of a muscle when not used or subjected to prolonged inactivity, such as when an arm is in a cast for a long time (see muscle atrophy).

Muscle atrophy: Muscle wasting or tissue loss that occurs when a muscle is no longer as active as usual. When muscles are no longer used movement and strength decline causing weakness. Neurogenic atrophy: This most severe type of muscle atrophy occurs when a nerve that connects to the muscle is injured or has a disease. This type of muscle atrophy tends to occur suddenly when compared to disuse atrophy that is more gradual.

Evidence Review

Background Pulsed electrical and electromagnetic stimulation are being investigated to improve functional status and relieve pain related to osteoarthritis (OA) and rheumatoid arthritis that is unresponsive to other standard therapies. Electrical stimulation is provided using a device that noninvasively delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered using coils placed over the skin.

Neuromuscular Electrical Stimulation Devices (NMES)


These devices, through multiple channels, attempt to stimulate motor nerves and alternately causes contraction and relaxation of muscles, unlike a TENS device which is intended to alter the perception of pain. NMES are used to prevent or retard disuse atrophy, relax muscle spasm, increase blood circulation, maintain or increase range of motion, and re-educate muscles.

This policy address the use of open loop neuromuscular systems which are used for simple tasks such as muscle strengthening alone, and typically in healthy individuals with intact neural control.

Functional neuromuscular stimulators are closed loop systems, which provide feedback information on muscle force and joint position, thus allowing constant modification of stimulation parameters which are required for complex activities such as walking. (These are addressed in a separate policy, see Related Medical Policies.) The RS 4m and RS 2m muscle stimulator are examples of devices that delivers neuromuscular electric stimulation.

Galvanic Stimulation Devices


Galvanic stimulation is characterized by high voltage, pulsed stimulation and is used primarily for local edema reduction through muscle pumping and polarity effect. Edema is comprised of negatively charged plasma proteins, which leak into the interstitial space. The theory of galvanic stimulation is that by placing a negative electrode over the edematous site and a positive electrode at a distant site, the monophasic high voltage stimulus applies an electrical potential which disperses the negatively charged proteins away from the edematous site, thereby helping to reduce edema.

Microcurrent Stimulation Devices (MENS)


MENS is characterized by subsensory current that acts on the body’s naturally occurring electrical impulses in an effort to decrease pain and facilitate the healing process. MENS differs from TENs in that it uses a significantly reduced level of electrical stimulation. TENS blocks pain, while MENS acts on the naturally occurring electrical impulses to decrease pain by stimulating the healing process.

Pulsed Electrical and Electromagnetic Stimulation Devices

Pulsed electrical and electromagnetic stimulation are being investigated to improve functional status and relieve pain related to osteoarthritis (OA) and rheumatoid arthritis (RA) unresponsive to other standard therapies. Noninvasive electrical stimulators generate a weak electrical current within the target site using pulsed electromagnetic fields, capacitive coupling, or combined magnetic fields. In capacitive coupling, small skin pads or electrodes are placed on either side of the knee or wrist. Electrical stimulation is provided by an electronic device that noninvasively delivers a subsensory low-voltage, monophasic electrical field to the target site of pain. Pulsed electromagnetic fields are delivered via treatment coils that are placed over the skin. Combined  magnetic fields deliver a time-varying magnetic field by superimposing the time-varying magnetic field onto an additional static magnetic field.

In basic research studies, pulsed electrical stimulation has been shown to alter chondrocyterelated gene expression in vitro and to have regenerative effects in animal models of cartilage injury. It is proposed that the device treats the underlying cause of the disease by stimulating the joint tissue and improving the overall health of the joint and that it provides a slow-acting, but longer-lasting improvement in symptoms.

Sympathetic Stimulation Devices


Sympathetic therapy describes a type of electrical stimulation of the peripheral nerves that is designed to stimulate the sympathetic nervous system in an effort to “normalize” the autonomic nervous system and alleviate chronic pain. Unlike TENS or interferential electrical stimulation, sympathetic therapy is not designed to treat local pain, but is designed to induce a systemic effect on sympathetically induced pain.

Sympathetic therapy uses four intersecting channels of various frequencies with bilateral electrode placement on the feet, legs, arms, and hands. Based on the location of the patient’s pain and treatment protocols supplied by the manufacturers, electrodes are placed in various locations on the lower legs and feet or the hands and arms. Electrical current is then induced with beat frequencies between 0 and 1000Hz. Treatment may include daily one-hour treatments in the physician’s office, followed by home treatments if the initial treatment is effective. Transcutaneous Electrical Modulation Pain Reprocessing (TEMPR) (CPT 0278T)

Scrambler Therapy/Calmare® device is also known as transcutaneous electrical modulation pain reprocessing (TEMPR). It is an electrocutaneous nerve stimulation device. It uses a biophysical rather than a biochemical approach. A “no-pain” message is transmitted to the nerve via disposable surface electrodes applied to the skin in the region of the patient’s pain. The perception of pain is cancelled when the no-pain message replaces that of pain, by using the same pathway through the surface electrodes in a non-invasive way. Regardless of pain intensity, a patient’s pain can be completely removed for immediate relief. Maximum benefit is achieved through follow-up treatments. The patient may be able to go for extended periods of time between subsequent treatments while experiencing significant pain control and relief. The period of time between treatments depends on the underlying cause and severity of the pain in addition to other factors. Treatment utilizing the Calmare® medical device may only be done under the direct supervision of allopathic physicians and other qualified licensed healthcare professionals who are certified in its use and application and are familiar with the principles, clinical applications, side effects and hazards associated with transdermal pain modulation.

CPT E0218, E0236, E0650,E0652, E1399 - Cooling Devices Used in the Outpatient Setting

Coding Code Description CPT

E0218 Water circulating cold pad with pump
E0236 Pump for water circulating pad
E0650 Pneumatic Compressor, nonsegmental home model
E0651 Pneumatic compressor, segmental home model without calibrated gradient pressure
E0652 Pneumatic compressor, segmental home model with calibrated gradient pressure
E1399 Durable medical equipment, miscellaneous





Introduction

Applying ice is known as cold therapy and helps reduce pain and swelling. Using a bandage or wrap to apply light pressure is known as compression therapy. Cold and compression therapy after surgery or injury is very effective in reducing inflammation, pain, and swelling. Using ice packs and bandages is the usual way of applying cold and compression therapy. A number of cooling devices have been developed. Some are manual while others use a small motor to cool water and move it within the wrap. Sometimes cooling devices are used in place of an ice pack and bandage. Cooling devices, including the types that add compression, are not medically necessary. Published medical studies do not show cooling devices provide better health results than ice packs and bandages.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Cooling Devices Medical Necessity

Circulating and noncirculating Circulating and noncirculating cooling devices, with or without compression, used in the outpatient setting are considered not medically necessary.




Benefit Application

Refer to benefit or contract language when assessing whether passive cooling devices would be considered durable medical equipment.

Circulating Cooling Devices


In active, circulating cooling devices, a motorized pump circulates chilled water and may also provide pneumatic compression.

* The AutoChill® device, which may be used with a CryoCuff®, consists of a pump that automatically exchanges water from the cuff to the cooler, eliminating the need for manual water recycling.

* CTM™ 5000 and cTreatment are computer-controlled devices that provide cooling at a specific (11°C, or 52ºF) and continuous temperature.

* Game Ready™ Accelerated Recovery System is an active circulating cooling device combined with a pneumatic component. The system consists of various soft wraps and a computercontrol unit to circulate the water through the wraps and provide intermittent pneumatic compression.

* Hilotherm® Clinic circulates cooled water through preshaped thermoplastic polyurethane facial masks for use after different types of facial surgery.

* Hot/Ice Thermal Blanket is another circulating cooling device. It consists of 2 rubber pads connected by a rubber hose to the main cooling unit. Fluid is circulated via the hose through the thermal blankets. The temperature of the fluid is controlled by the main unit and can be either hot or cold.

* ThermaZone® provides thermal therapy with pads specific to various joints as well as different areas of the head (front, sides, back, eyes).

Summary of Evidence

For individuals who have pain and/or swelling after knee surgery who receive a cooling device, the evidence includes systematic reviews, several randomized controlled trials, and a casecontrol study. Relevant outcomes are symptoms, functional outcomes, medication use, and resource utilization. Evidence on manually operated passive noncirculating cooling devices is limited by the control condition used in the trials. Studies that used either a no-icing control or infrequent ice applications do not provide sufficient evidence of comparative efficacy. Other studies have provided no information on the frequency of ice changes, limiting interpretation of the results. Several randomized trials have compared active circulating cooling devices with standard intermittent icing or cold packs, and two of the larger trials found no significant benefit of the continuous cooling devices. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have pain and/or swelling after shoulder surgery who receive a cooling device, the evidence includes a randomized controlled trial. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. Evidence found that use of compressive cryotherapy produced no significant reduction in pain or medication use compared with the standard ice wrap. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have pain and/or swelling after facial surgery who receive a cooling device, the evidence includes several small randomized controlled trials and a pilot study. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. There have been mixed results regarding the intervention’s efficacy in reducing neurologic problems as well as improving eye motility, diplopia, mandible functioning, and mouth opening compared with conventional cooling regimens. The evidence is insufficient to determine the effects of the technology on health outcomes.

CPT 0126T, 93895 - Assessment of Subclinical Atherosclerosis

Coding Code Description CPT

0126T Common carotid intima-media thickness (IMT) study for evaluation of atherosclerotic burden or coronary heart disease risk factor assessment

93895 Quantitative carotid intima media thickness and carotid atheroma evaluation, bilateral

Introduction

Atherosclerosis is a condition in which plaque builds up on artery walls. Plaque is made up of fat, cholesterol, and other substances in the blood. Over time, the plaque hardens. This hardening causes the arteries to narrow. Narrowed arteries means less blood can flow to organs like the heart and brain. There are a number of well proven tests that doctors use to diagnose atherosclerosis. A newer test uses sound waves (ultrasound) to look at the two innermost layers of the carotid artery. (The carotid arteries are on both sides of the neck.) The goal of this ultrasound test is to try to see if plaque is building up in arteries before other tests are able identify it. Medical studies have found that this type of ultrasound test is uncertain in trying to predict who will develop atherosclerosis. Also, there are no studies showing how this testing leads to better health results compared to standard testing. For these reasons, ultrasound testing to try to identify atherosclerosis is considered investigational.

Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage Criteria Service Investigational

Ultrasonographic measurement of carotid artery intima-medial thickness (CIMT)

Ultrasonographic measurement of carotid artery intima-medial thickness (CIMT) as a technique for identifying subclinical atherosclerosis is considered investigational for use in the screening, diagnosis, or management of atherosclerotic disease.


Evidence Review Description

Ultrasonographic measurement of carotid intima-medial (or intimal-media) thickness (CIMT) refers to the use of B-mode ultrasound to determine the thickness of the two innermost layers  thickening, which is a surrogate marker for atherosclerosis, may provide an opportunity to intervene earlier in atherogenic disease and/or monitor disease progression.

Background

Coronary Heart Disease


Coronary heart disease (CHD) accounts for 30.8% of all deaths in the United States.1 Established major risk factors for CHD have been identified by the National Cholesterol Education Program Expert Panel. These risk factors include elevated serum levels of low-density lipoprotein cholesterol, total cholesterol, and reduced levels of high-density lipoprotein cholesterol. Other risk factors include a history of cigarette smoking, hypertension, family history of premature CHD, and age.

Diagnosis

The third report of the National Cholesterol Education Program Adult Treatment Panel established various treatment strategies to modify the risk of CHD, with emphasis on target goals of low-density lipoprotein cholesterol. Pathology studies have demonstrated that levels of traditional risk factors are associated with the extent and severity of atherosclerosis. The third report of the National Cholesterol Education Program Adult Treatment Panel recommended use of the Framingham criteria to further stratify those patients with 2 or more risk factors for more intensive lipid management.2 However, at every level of risk factor exposure, there is substantial variation in the amount of atherosclerosis, presumably related to genetic susceptibility and the influence of other risk factors. Thus, there has been interest in identifying a technique that can improve the ability to diagnose those at risk of developing CHD, as well as to measure disease progression, particularly for those at intermediate risk.

The carotid arteries can be well visualized by ultrasonography, and ultrasonographic measurement of the carotid artery intima-medial thickness has been investigated as a technique to identify and monitor subclinical atherosclerosis. B-mode ultrasound is most commonly used to measure carotid intima-media thickness. The intima-medial thickness (IMT) is measured and averaged over several sites in each carotid artery. Imaging of the far wall of each common carotid artery yields more accurate and reproducible IMT measurements than imaging of the near wall. Two echogenic lines are produced, representing the lumen-intima interface and the media-adventitia interface. The distance between these two lines constitutes the IMT.

Summary of Evidence

For individuals who are undergoing cardiac risk assessment who receive ultrasonic measurement of carotid intima-media thickness (CIMT), the evidence includes large cohort studies, casecontrol studies, and systematic reviews. Relevant outcomes are test accuracy and morbid events.

Some studies have correlated increased CIMT with other commonly used markers for risk of coronary heart disease (CHD) and with risk for future cardiovascular events. A meta-analysis of individual patient data by Lorenz et al (2012) found that CIMT was associated with increased cardiovascular events although CIMT progression over time was not associated with increased cardiovascular event risk. In a systematic review by Peters et al (2012), the added predictive value of CIMT was modest, and the ability to reclassify patients into clinically relevant categories was not demonstrated. The results from these reviews and other studies have demonstrated the predictive value of CIMT is uncertain, and that the predictive ability for any level of population risk cannot be determined with precision. Also, available studies do not define how the use of CIMT in clinical practice improves outcomes. There is no scientific literature that directly tests the hypothesis that measurement of CIMT results in improved patient outcomes and no specific guidance on how measurements of CIMT should be incorporated into risk assessment and risk management. The evidence is insufficient to determine the effects of the technology on health outcomes.

CPT 95905, G0255 - Automated Point-of-Care Nerve Conduction Tests

Coding Code Description CPT

95905 Motor and/or sensory nerve conduction, using preconfigured electrode array(s), amplitude and latency/velocity study, each limb, includes F-wave study when performed, with interpretation and report HCPCS

G0255 Current perception threshold/sensory nerve conduction test (SNCT), per limb

Introduction

A nerve conduction test looks at how well nerves work. The purpose of the test is to see if a nerve is damaged. Two electrodes — patches attached to the skin that can transmit electrical signals — are placed along the path of the nerve being tested. An electrical signal is sent to the first electrode, with the second electrode receiving and recording the signal. The time it takes the electrical signal to travel between the two electrodes indicates how well the signal travels along the nerve. Specialized equipment is needed to do these tests. Newer types of portable equipment have been developed to try to do nerve conduction tests. Portable equipment is not as specialized and doesn’t require special training to use it. Portable equipment for nerve conduction studies is considered unproven. More studies are needed to show if the nerve conduction studies done on portable equipment by non-specialists gives information that is the same as or better information than standard nerve conduction studies. Note: The Introduction section is for your general knowledge and is not to be taken as policy coverage criteria. The rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy informs them about when a service may be covered.

Policy Coverage

Testing Investigational Automated point-of-care nerve conduction tests Automated point-of-care nerve conduction tests are considered investigational.


Related Information N/A

Evidence Review Description


Portable devices have been developed to provide point-of-care (POC) nerve conductions studies (NCSs). These devices have computational algorithms that can drive stimulus delivery, measure and analyze the response, and report study results. Automated nerve conduction could be used in various settings, including primary care, without the need for specialized training or equipment.


Background Electrodiagnostic Testing

Nerve conduction studies (NCSs) and needle electromyography (EMG), when properly performed by a trained practitioner, are considered the criterion standard of electrodiagnostic testing for the evaluation of focal and generalized disorders of peripheral nerves. However, the need for specialized equipment and personnel may limit the availability of electrodiagnostic testing for some patients.

Carpal Tunnel Syndrome

Carpal tunnel syndrome is a pressure-induced entrapment neuropathy of the median nerve as it passes through the carpal tunnel, resulting in sensorimotor disturbances. This syndrome is defined by its characteristic clinical symptoms, which may include pain, subjective feelings of swelling, and nocturnal paresthesia.

Diagnosis

A variety of simple diagnostic tools are available, and a positive response to conservative management (steroid injection, splints, modification of activity) can confirm the clinical diagnosis.1 Electrodiagnostic studies may also be used to confirm the presence or absence of a median neuropathy at the wrist, assess the severity of the neuropathy, and assess associated diagnoses. Nerve conduction is typically assessed before the surgical release of the carpal tunnel, but the use of EMG in the diagnosis of carpal tunnel syndrome is controversial. One proposed use of automated nerve conduction devices is to assist in the diagnosis of carpal tunnel syndrome.

Lumbosacral Radiculopathy


Electrodiagnostic studies are useful in the evaluation of lumbosacral radiculopathy in the presence of disabling symptoms of radiculopathy or neuromuscular weakness. These tests are most commonly considered in patients with persistent disabling symptoms when neuroimaging findings are inconsistent with clinical presentation. Comparisons of automated point-of-care

(POC) NCSs with EMGs and standardized NCSs have been evaluated as alternative electrodiagnostic tools.

Peripheral Neuropathy


Peripheral neuropathy is relatively common in patients with diabetes, and the diagnosis is often made clinically through the physical examination. Diabetic peripheral neuropathy can lead to morbidity including pain, foot deformity, and foot ulceration.

Diagnosis


Clinical practice guidelines have recommended using simple sensory tools such as the 10-g Semmes-Weinstein monofilament or the 128-Hz vibration tuning fork for diagnosis.2 These simple tests show the presence of neuropathy defined by electrophysiologic criteria with a high level of accuracy. Electrophysiologic testing may be used in research studies and may be required in cases with an atypical presentation. POC nerve conduction testing has been proposed as an alternative to standard electrodiagnostic methods for the diagnosis of peripheral neuropathy and, in particular, for detecting neuropathy in patients with diabetes.

Normative Values

NeuroMetrix (2009) published reference ranges for key nerve conduction parameters in healthy subjects.3 Data analyzed were pooled from 5 studies, including from 92 to 848 healthy subjects with data on the median, ulnar, peroneal, tibial, and sural nerves. Subject age and height were found to affect the parameters. In addition to providing reference ranges for clinicians to use (providing that NCS techniques are consistent with those described in the article), the authors stated that clinicians could use the same method to develop their reference ranges. At this time, the proposed reference ranges have not been validated in a clinical patient population. Due to the lack of uniform standards in nerve conduction testing in the United States, the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) identified 7 criteria that would identify high-quality NCS articles that would be appropriate for using as referent standards (2016). AANEM identified normative criteria for nerve conduction velocity tests based on a review of high-quality published studies (see Table 1). In March 2017, the American Academy of Neurology affirmed AANEM’s recommendations.5

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