Fecal microbiota transplantation using a compounded product (see Policy Guidelines) may be considered medically necessary for the treatment of individuals with recurrent Clostridioides difficile infection under the following condition (see Policy Guidelines section for U.S. Food and Drug Administration Guidance):

There have been at least 2 recurrences that are refractory to standard antibiotic treatment.

Fecal microbiota transplantation using a Food and Drug Administration (FDA)-approved product may be considered medically necessary for the treatment of individuals with recurrent Clostridioides difficile infection under the following condition (see Policy Guidelines section for U.S. Food and Drug Administration Guidance):

There have been at least 2 recurrences that are refractory to standard antibiotic treatment; and

The recipient is 18 years of age or older.

Fecal microbiota transplantation is considered investigational in all other situations.

The diagnosis of lumbar radiculopathy is typically made by a combination of suggestive signs and symptoms in conjunction with imaging that demonstrates compression of a spinal nerve root. Symptoms are due to irritation of the spinal nerve root at L4, L5, or S1, and may include posterior leg pain that extends past the knee, a loss of sensation in a dermatomal pattern, and/or loss of deep tendon reflexes. However, all of these symptoms may not be present. On exam, provocative tests such as the straight leg maneuver are positive. Magnetic resonance imaging is the most useful imaging modality and can confirm or exclude the presence of nerve root compression, most commonly due to a herniated disc.

Several aspects of epidural steroid injection (ESI) therapy are not standardized. Expert opinion was sought through clinical vetting on the following issues:

The optimal time for assessing a response to ESIs. Expert opinion supports that response can be assessed anytime from immediately to several weeks after the procedure, with the most popular time to assess response being 1 to 2 weeks after injection.

The definition of a clinically significant response to injections. Expert opinion supports that a reasonable definition of response is at least a 20-point improvement on a 0-to-100 visual analog scale, or an improvement of at least 50% in functional status when measured using a validated scale.

The maximum number of injections in 1 year. There is no agreement on the maximum number of injections that should be given in 1 year. Some experts recommend that no more than 3 injections should be given in 1 year, but other experts believe that more than 3 per year can be used safely. None of the expert opinions supported more than 6 injections given over a 12-month period.

Conservative nonsurgical therapy for at least 4 weeks should include the following:

Use of prescription-strength analgesics for several weeks at a dose sufficient to induce a therapeutic response

Analgesics should include anti-inflammatory medications with or without adjunctive medications such as nerve membrane stabilizers or muscle relaxants AND

Participation in at least 4 weeks of physical therapy (including active exercise) or documentation of why the patient could not tolerate physical therapy, AND

Evaluation and appropriate management of associated cognitive and behavioral issues.

The use of peanut (Arachis hypogaea) allergen powder-dnfp is considered investigational for all indications.

Prescription digital health technologies for diagnostic application that have received clearance for marketing by the U.S. Food and Drug Administration as a diagnostic aid for autism spectrum disorder (Canvas Dx) are considered investigational.

Percutaneous coronary transluminal angioplasty is considered for payment in the treatment of acute myocardial infarction as an alternative method for patients who do not have contraindications for thrombolysis.

Coronary transluminal percutaneous angioplasty is considered for payment as the first option for patients with contraindications for thrombolysis such as cardiogenic shock, advanced age, or a previous history of coronary bypass.

Alcohol injections are considered investigational for treatment of Morton neuroma.

Trigger point injections with anesthetic and/or corticosteroid may be considered medically necessary for the treatment of myofascial pain syndrome when all of the following criteria have been met:

There is a regional pain complaint in the expected distribution of referral pain from a trigger point, AND

There is spot tenderness in a palpable taut band in a muscle, AND

There is restricted range of motion, AND

Conservative therapy (eg, physical therapy, active exercises, ultrasound, heating or cooling, massage, activity modification, or pharmacotherapy) for 6 weeks fails or is not feasible, AND

Trigger point injections are provided as a component of a comprehensive therapy program, AND

No more than 4 injections are given in a 12-month period.

Trigger point and tender point injections are considered investigational for all other indications, including the treatment of myofascial pain syndrome not meeting the criteria above, complex regional pain syndrome, abdominal wall pain, and fibromyalgia.

Ultrasound and other imaging guidance of trigger point injections are considered investigational.

Measurement of gastrointestinal transit times, including gastric emptying and colonic transit times, using an ingestible pH and pressure capsule is considered investigational for the evaluation of suspected gastroparesis, constipation, or other gastrointestinal motility disorders.

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

This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims.

Opdivo may be considered medically necessary in patients 18 years of age or older for unresectable or metastatic melanoma, adjuvant treatment of melanoma, metastatic non-small cell lung cancer, renal cell carcinoma, relapsed or progressed classical Hodgkin lymphoma, recurrent or metastatic squamous cell carcinoma Head and Neck, locally advanced or metastatic urothelial carcinoma, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)metastatic colorectal cancer, hepatocellular carcinoma, malignant pleural mesothelioma, small cell lung cancer, Not FDA approved indication for metastatic anal carcinoma or Merkel cell carcinoma; and if the conditions indicated below are met.

Nivolumab (Opdivo) is recommended by the NCCN Drugs and Biologics Compendium® for off-label use for the following indications:

•    Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) – as initial therapy as a single agent or in combination with ibrutinib for either clonally related or unknown clonal status Richter’s transformation to diffuse large B-cell lymphoma in patients with del(17p)/TP53 mutations and who are chemotherapy refractory and unable to receive chemoimmunotherapy
•    Classic Hodgkin lymphoma – as single agent, palliative therapy for individuals age 60 and older with relapsed or progressive disease following autologous HSCT without brentuximab vedotin, relapsed/refractory disease and transplant-ineligible based on comorbidity or failure of second-line therapy, or post-allogeneic transplant
•    Classic Hodgkin lymphoma – as single agent, third-line or subsequent therapy for relapsed or progressive disease after autologous hematopoietic stem cell transplant without brentuximab vedotin, for relapsed/refractory disease and transplant-ineligible based on comorbidity or failure of second-line chemotherapy, or post-allogeneic transplant individuals age ≥ 18 and < 60 •    CNS - Brain metastases (limited) – in combination with ipilimumab (preferred) or as a single agent for limited brain metastases in patients with melanoma as initial treatment in select patients, as treatment for recurrent brain metastases, or as treatment of relapsed disease with either stable systemic disease or reasonable systemic treatment options •    CNS Brain metastases (limited) - as a single agent for limited brain metastases in patients with PD-L1 positive non-small cell lung cancer as initial treatment in select patients, as treatment for recurrent brain metastases, or as treatment of relapsed disease with either stable systemic disease or reasonable systemic treatment options •    CNS - Brain metastases (extensive) - in combination with ipilimumab (preferred) or as a single agent for extensive brain metastases in patients with melanoma as primary treatment in select patients or as treatment for recurrent disease with stable systemic disease or reasonable systemic treatment options •    CNS Brain metastases (extensive) - as a single agent for extensive brain metastases in patients with PD-L1 positive non-small cell lung cancer as primary treatment in select patients or as treatment for recurrent disease with stable systemic disease or reasonable systemic treatment options •    Colon cancer - as primary treatment for locally unresectable or medically inoperable disease as a single agent or in combination with ipilimumab •    Colon cancer - adjuvant therapy for dMMR/MSI-H tumors as a single agent or in combination with ipilimumab following resection and/or local therapy for resectable metachronous metastases, unresectable metachronous metastases that converted to resectable disease after primary treatment, and following synchronized or staged resection for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment •    Colon cancer - primary neoadjuvant treatment for dMMR/MSI-H, resectable synchronous liver and/or lung metastases as a single agent or in combination with ipilimumab •    Colon cancer - as primary or initial therapy for unresectable or metastatic dMMR/MSI-H only disease as a single agent or in combination with ipilimumab for unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy, unresectable synchronous liver and/or lung metastases only, synchronous abdominal/peritoneal metastases, synchronous unresectable metastases of other sites, primary treatment for unresectable metachronous metastases, or unresectable metachronous metastases that remain unresectable after primary treatment •    Colon cancer - as single agent treatment for progression of dMMR/MSI-H unresectable advanced disease •    Extranodal NK/T-cell lymphoma, nasal type - as a single agent for relapsed or refractory disease following additional therapy with an alternate asparaginase-based combination chemotherapy regimen, not previously used and when a clinical trial is not available •    Melanoma (cutaneous) - as single agent, adjuvant therapy for resected stage III sentinel node-positive disease during nodal basin ultrasound surveillance or after completion lymph node dissection; stage III disease with clinically positive node(s) following wide excision of primary tumor and therapeutic lymph node dissection; stage III disease with clinical satellite/in-transit metastases if no evidence of disease after complete excision to clear margins; stage III disease with clinical satellite/in-transit metastases if no evidence of disease after initial local or regional therapy; local satellite/in-transit recurrence after complete excision to clear margins; local satellite/in-transit recurrence and no evidence of disease after initial local or regional therapy; or following therapeutic lymph node dissection and/or complete resection of nodal recurrence •    Melanoma (cutaneous) - as a single agent or in combination with ipilimumab as initial therapy for limited resectable stage III disease with clinical satellite/in-transit metastases or limited resectable local satellite/in-transit recurrence •    Melanoma (cutaneous) - reinduction therapy as a single agent or in combination with ipilimumab for metastatic or unresectable disease when prior anti PD-1 checkpoint inhibitor immunotherapy resulted in disease control with subsequent disease progression or relapse more than 3 months after treatment was discontinued and when there is no residual toxicity •    Vulvar cancer - as single agent, second-line therapy for HPV-related, locally advanced or metastatic disease Opdivo is considered investigational in all other patients and for all other indications.

Keytruda may be considered medically necessary in patients with:

Labeled Indications:

Melanoma:

Adjuvant treatment of melanoma with lymph node(s) involvement following complete resection

Treatment of unresectable or metastatic melanoma

Non-small cell lung cancer:

First-line, single-agent treatment of non-small cell lung cancer (NSCLC) in patients with stage III NSCLC (who are not candidates for surgical resection or definitive chemoradiation) or in patients with metastatic NSCLC, and with tumors with PD-L1 expression (tumor proportion score [TPS] ≥1%), as determined by an approved test, and with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) genomic tumor aberrations

First-line treatment (in combination with pemetrexed and platinum chemotherapy) of metastatic nonsquamous NSCLC in patients with no EGFR or ALK genomic tumor aberrations

First-line treatment (in combination with carboplatin and either paclitaxel or paclitaxel [protein bound]) of metastatic squamous NSCLC

Single-agent treatment of metastatic NSCLC in patients with tumors with PD-L1 expression (TPS ≥1%), as determined by an approved test, and with disease progression on or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression (on approved EGFR- or ALK-directed therapy) prior to receiving pembrolizumab.

Off-label dosing (in patients with metastatic non-small cell lung cancer (NSCLC) with disease progression following platinum-containing chemotherapy): 2 mg/kg once every 3 weeks for 24 months or until disease progression or unacceptable toxicity (Herbst 2016).

Small cell lung cancer (metastatic): Treatment of metastatic small cell lung cancer in patients with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy

Head and neck cancer, squamous cell (recurrent or metastatic):

First-line treatment (in combination with platinum and fluorouracil) of metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC)

First-line, single-agent treatment of metastatic or unresectable recurrent HNSCC in patients whose tumors express PD-L1 (CPS ≥1), as determined by an approved test

Single-agent treatment of recurrent or metastatic HNSCC in patients with disease progression on or after platinum-containing chemotherapy

Hodgkin lymphoma, classical (relapsed or refractory): Treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or patients who have relapsed after 3 or more prior lines of therapy

Primary mediastinal large B-cell lymphoma (relapsed or refractory): Treatment of primary mediastinal large B-cell lymphoma (PMBCL) in adult and pediatric patients with refractory disease or who have relapsed after 2 or more prior lines of therapy

Limitation of use: Not recommended for treatment of PMBCL in patients who require urgent cytoreductive therapy

Urothelial carcinoma (locally advanced or metastatic):

Treatment of locally advanced or metastatic urothelial cancer in patients who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (CPS ≥10) as determined by an approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status

Treatment of locally advanced or metastatic urothelial cancer in patients with disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy

Microsatellite instability-high cancer (unresectable or metastatic):

Solid tumors: Treatment of unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors in adult and pediatric patients that have progressed following prior treatment and have no satisfactory alternate treatment options.

Limitation of use: Safety and efficacy in pediatric patients with MSI-H central nervous system cancers have not been established.

Colorectal cancer: Treatment of unresectable or metastatic, MSI-H or mismatch repair deficient colorectal cancer in adult and pediatric patients that have progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

Obinutuzumab

Intravenous obinutuzumab (Gazyva) may be considered medically necessary to treat patients with NHL for the following FDA labeled indications:

Follicular lymphoma (FL):

· In combination with chemotherapy followed by obinutuzumab monotherapy in patients achieving at least a partial remission, is indicated for the treatment of adult patients with previously untreated stage II bulky, III or IV FL.

· In combination with bendamustine followed by obinutuzumab monotherapy, for the treatment of patients with FL who relapsed after, or are refractory to, a rituximab-containing regimen.

Chronic lymphocytic leukemia (CLL):

· In combination with chlorambucil, for the treatment of patients with previously untreated CLL.

Obinutuzumab (Gazyva) is considered investigational for relapsed or refractory CLL.

CLL is considered to be identical (ie, one disease with different manifestations) to the mature (peripheral) B cell neoplasm small lymphocytic lymphoma (SLL), one of the indolent non-Hodgkin lymphomas. The term CLL is used when the disease manifests primarily in the bone marrow and blood while the term SLL is used when involvement is primarily nodal.

«Follicular Lymphoma (grade 1-2)

– First-line therapy for stage I, contiguous stage II, non-contiguous stage II disease, or for patients with indications for treatment with stage III or IV disease  preferred in combination with bendamustine, CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CVP (cyclophosphamide, vincristine, and prednisone) regimens in combination with lenalidomide. Second-line and subsequent therapy (if not previously given) for no response, relapsed, or progressive disease in patients with indications for treatment preferred* in combination with bendamustine, CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CVP (cyclophosphamide, vincristine, and prednisone) regimen as a single agent or in combination with lenalidomide
*obinutuzumab is preferred in rituximab refractory patients, which includes disease progressing on or within 6 months of prior rituximab therapy. Single-agent maintenance therapy  preferred as optional first-line consolidation or extended dosing following chemoimmunotherapy preferred as optional second-line consolidation or extended dosing for rituximab-refractory disease»

«Gastric MALT Lymphoma

-Second-line and subsequent therapy for relapsed, refractory, or progressive disease in patients with indications for treatment preferred in combination with bendamustine (not recommended if previously
treated with bendamustine) as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen as a component of CVP (cyclophosphamide, vincristine, and prednisone with obinutuzumab regimen in combination with lenalidomide»

«Nongastric MALT Lymphoma (Noncutaneous)

-Second-line and subsequent therapy for relapsed, refractory, or progressive disease in patients with indications for treatment preferred in combination with bendamustine (not recommended if previously
treated with bendamustine) as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and
prednisone) with obinutuzumab regimen as a component of CVP (cyclophosphamide, vincristine, and prednisone) with obinutuzumab regimen in combination with lenalidomide»

«Nodal Marginal Zone Lymphoma

-First-line therapy for stage I, contiguous stage II, non-contiguous stage II, or stage III, IV disease in patients with indications for treatment  in combination with bendamustine (preferred) as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen as a component of CVP (cyclophosphamide, vincristine, and prednisone) with obinutuzumab regimen»

«Splenic Marginal Zone Lymphoma

-Second-line therapy for disease recurrence following initial management of splenomegaly (if previously treated with rituximab) and subsequent therapy in patients with indications for treatment  preferred in combination with bendamustine (not recommended if previously treated with bendamustine)
as a component of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) with obinutuzumab regimen as a component of CVP (cyclophosphamide, vincristine, and prednisone) with
obinutuzumab regimen in combination with lenalidomide»

«Mantle Cell Lymphoma

-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis»

«Diffuse Large B-Cell Lymphoma

-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »

«Histologic Transformation of Indolent Lymphomas to Diffuse Large B-Cell Lymphoma

-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »

«High-Grade B-Cell Lymphomas

-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »

«Burkitt Lymphoma

-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »

«AIDS-Related B-Cell Lymphomas

-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis»

«Post-Transplant Lymphoproliferative Disorders

-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis,vesiculobullous dermatitis, and toxic epidermal necrolysis»

«Castleman Disease

-Used as a substitute* for rituximab in patients with intolerance (including those experiencing severe hypersensitivity reactions requiring discontinuation of rituximab) as well as rare complications such as mucocutaneous reactions including paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis »

«Hairy Cell Leukemia

-Consider in combination with vemurafenib as initial therapy for patients with indications for treatment who are unable to tolerate purine analogs including frail patients and those with active infection (useful in certain circumstances)»

«Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

-First-line therapy for CLL/SLL without del(17p)/TP53 mutation in patients who have indications for treatment  in combination with acalabrutinib (preferred) in combination with ibrutinib* *recommended only in patients ≥65 years of age and younger patients with significant comorbidities (creatinine clearance <70 mL/min) "

Intra-articular hyaluronan injections of the knee are considered investigational.

Intra-articular hyaluronan injections are considered investigational for all other joints.

Polysomnography (PSG) and a multiple sleep latency test performed on the day after the PSG may be considered medically necessary in the evaluation of suspected narcolepsy or idiopathic hypersomnia.

PSG may be medically necessary when evaluating individuals with parasomnias when there is a history of sleep-related injurious or potentially injurious disruptive behaviors.

PSG may be medically necessary when a diagnosis of periodic limb movement disorder is considered when there is:

A complaint of repetitive limb movement during sleep by the individual or an observer; and

No other concurrent sleep disorder; and

At least one of the following is present:

Frequent awakenings; or

Fragmented sleep; or

Difficulty maintaining sleep; or

Excessive daytime sleepiness.

PSG for the diagnosis of periodic limb movement disorder is considered investigational when there is concurrent untreated obstructive sleep apnea, restless legs syndrome, narcolepsy, or rapid eye movement sleep behavior disorder.

PSG is considered investigational for the diagnosis of non-respiratory sleep disorders not meeting the criteria above, including but not limited to nightmare disorder, depression, sleep-related bruxism, or noninjurious disorders of arousal.

Navigated transcranial magnetic stimulation is considered investigational for all purposes, including but not limited to the preoperative evaluation of individuals being considered for brain surgery when localization of eloquent areas of the brain (eg, controlling verbal or motor function) is an important consideration in surgical planning.

Neurofeedback is considered investigational.

Biofeedback in the outpatient setting is considered investigational as a treatment of urinary incontinence in adults.

Unsupervised home use of biofeedback for treatment of urinary incontinence is investigational.

Sublingual immunotherapy using Oralair, Grastek, or Ragwitek may be considered medically necessary, when used according to U.S. Food and Drug Administration (FDA) labeling, for the treatment of pollen-induced allergic rhinitis or rhinoconjunctivitis 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 (see Policy Guidelines section).

Patient’s symptoms are not adequately controlled by appropriate pharmacotherapy (see Policy Guidelines section).

Sublingual immunotherapy using Odactra may be considered medically necessary, when used according to FDA labeling, for the treatment of house dust mite-induced allergic rhinitis or rhinoconjunctivitis when the following conditions are met:

Patient has a history of rhinitis or rhinoconjunctivitis symptoms related to dust mite exposure.

Patient has a documented positive house dust mite-specific skin test or house dust mite-specific immunoglobulin E test (see Policy Guidelines section).

Patient’s symptoms are not adequately controlled by appropriate pharmacotherapy (see Policy Guidelines section).

Sublingual immunotherapy as a technique of allergy immunotherapy is considered investigational for all other uses.

La utilización de la prueba de la mesa o tabla de oscilación para el diagnostico de síncope no se considera para pago.
La utilización de la prueba de la mesa o tabla de oscilación se considera para pago cuando se utiliza para la clasificación del sincope neurogénico en aquellos pacientes que están siendo considerados para la colocación de un marcapasos.
Esta prueba solo se autorizará para realizarse en laboratorios de cateterismo cardiaco o laboratorios electrofisiológicos.

El análisis comprensivo de la marcha se considera para pago como una herramienta en la planificación de la cirugía en paciente con desordenes de la marcha asociados a perlesía cerebral.

El análisis comprensivo de la marcha no se considera para pago para cualquier otra aplicación incluyendo per no limitando:

La planificación de otras cirugías para otros desordenes de la marcha no asociada a la perlesía cerebral.

La evaluación post operatoria de los resultados quirúrgicos y rehabilitación para todas las condiciones.

Biofeedback is considered investigational as a treatment of the following miscellaneous conditions:

anxiety disorders

asthma

Bell palsy

depression

hypertension

insomnia

movement disorders, such as motor function after stroke, injury, or lower-limb surgery

multiple sclerosis

orthostatic hypotension in patients with spinal cord injury

pain management during labor

posttraumatic stress disorder

prevention of preterm birth

Raynaud disease

sleep bruxism

tinnitus

Stationary oxygen equipment and home oxygen therapy are covered for payment when the following criteria is met:

·         At least one of the following diagnosis:

o    Chronic obstructive pulmonary disease

o    Cystic Fibrosis

o    Bronchiectasis

o    Lung Cancer

o    Pulmonary hypertension

o    Erythrocytosis

o    Pneumonia

o    Asthma

o    Bronchitis

o    Bronchiolitis

o    Recurring congestive heart failure due to cor pulmonale

·         For cluster headache diagnosis when other therapies have failed.

·         Hypoxemia evidence by any combination of the following clinical findings and oxygenation results (taken at room air unless medically contraindicated):

o    PO2 ≤ 55 mm Hg or arterial oxygen saturation ≤ 88% at rest.

o    PO2 ≤ 55 mm Hg or arterial oxygen saturation ≤ 88% for at least 5 minutes taken during sleep for a person with a PO2 ≥ 56 mm Hg or arterial oxygen saturation ≥ 89% awake.

o    A decrease of more than 10 mm Hg in arterial PO2, or a reduction in arterial oxygen saturation for more than 5% for at least 5 minutes of sleep

o    Decrease in arterial PO2 of more than 10 mm Hg or a decrease in arterial oxygen saturation more than 5% for at least 5 minutes taken during sleep associated with symptoms or signs attributable to hypoxemia including, but not limited to, cor pulmonale, “P” pulmonale on electrocardiogram [EKG], pulmonary hypertension, and erythrocytosis.

o    Arterial PO2 ≤ 55-59 mm Hg or or arterial oxygen saturation ≤ 89% at rest, for at least 5 minutes during sleep or during exercise (as described in the first bullet) and one of the following:

§  Dependent edema associated with congestive heart failure

§  Pulmonary hypertension, chronic cor pulmonale or congestive heart failure with hypoxemia

§  Erythrocythemia with a hematocrit greater than 56%

Portable oxygen systems are covered for payment when criteria for stationary oxygen necessity is met and the patient is mobile within the home.

Portable oxygen concentrators and combinations of stationary/portable oxygen systems are covered for payment when the above criteria are met, and the

patient is active and frequently exceeds the time limitations in conventional ambulatory oxygen systems.

Rinimetría y rinomería acústica/óptica no proceden para pago. Ningún estudio ha demostrado que el uso de esta metodología objetiva mejore resultados cuando se compara con la propia evaluación del paciente.

A rigid cervical-thoracic-lumbar-sacral or thoracic-lumbar-sacral orthosis may be considered medically necessary for the treatment of scoliosis in juvenile and adolescent individuals at high risk of progression that meets the following criteria:

Idiopathic spinal curve angle between 25° and 40°; AND

Spinal growth has not been completed (Risser grade 0-3; no more than 1 year after menarche in females)

OR

Idiopathic spinal curve angle greater than 20°; AND

There is a documented increase in the curve angle; AND

At least 2 years of growth remain (Risser grade 0 or 1; premenarche in females).

Use of an orthosis for the treatment of scoliosis that does not meet the criteria above is considered investigational.

Vertebral body stapling and vertebral body tethering for the treatment of scoliosis are considered investigational.

Biofeedback may be considered medically necessary as part of the overall treatment plan for migraine and tension-type headache.

Biofeedback for the treatment of cluster headache is investigational.

Unsupervised home use of biofeedback for treatment of headache is not medically necessary.

Psoralen plus ultraviolet A for the treatment of severe, disabling psoriasis, which is not responsive to other forms of conservative therapy (eg, topical corticosteroids, coal/tar preparations, ultraviolet light) may be considered medically necessary.

Targeted phototherapy may be considered medically necessary for the treatment of moderate-to-severe localized psoriasis (ie, comprising <20% body area) for which narrowband ultraviolet B or psoralen plus ultraviolet A are indicated. Targeted phototherapy may be considered medically necessary for the treatment of mild-to-moderate localized psoriasis that is unresponsive to conservative treatment. Targeted phototherapy is considered investigational for the first-line treatment of mild psoriasis. Targeted phototherapy is considered investigational for the treatment of generalized psoriasis or psoriatic arthritis.

Chromoendoscopy is considered investigational as an adjunct to diagnostic or surveillance colonoscopy.

Virtual chromoendoscopy is considered investigational as an adjunct to diagnostic or surveillance colonoscopy.

Algunas formas de vértigo y nistagmo son evidentes sólo con cambios en la posición de la cabeza con respecto a la gravedad. Por ejemplo lesiones a nivel central, (el tronco cerebral o cerebelo) y periférico (por ejemplo, canalitiasis) pueden causar nistagmo posicional y vértigo. La distinción entre estas dos entidades es importante ya que las lesiones centrales a menudo requieren algún tipo de intervención. Nistagmo posicional central es normalmente estático, ya que el nistagmo persiste mientras la cabeza se mantiene en la posición que lo provoca. Vértigo posicional debido a patología vestibular periférica es siempre transitoria. Observaciones de la dirección del nistagmo, así como características de latencia y fatigabilidad, pueden ayudar a confirmar una localización periférica y hacer innecesaria la toma de imágenes. Los pacientes que tienen nistagmo con características atípicas o nistagmo de origen no determinado deben ser examinados e investigados para detectar signos neurológicos

Hypnosis is considered medically necessary when used to control acute or chronic pain, or as an adjunct to psychotherapy. Hypnosis used as an anesthesia is considered not medically necessary.

Use of platelet-rich plasma is considered investigational for all orthopedic indications. This includes, but is not limited to, use in the following situations:

Primary use (injection) for the following conditions:

Achilles tendinopathy

Lateral epicondylitis

Plantar fasciitis

Osteochondral lesions

Osteoarthritis.

Adjunctive use in the following surgical procedures:

Anterior cruciate ligament reconstruction

Hip fracture

Long-bone nonunion

Patellar tendon repair

Rotator cuff repair

Spinal fusion

Subacromial decompression surgery

Total knee arthroplasty.

Radiofrequency ablation may be considered medically necessary for the treatment of Barrett esophagus with high-grade dysplasia (see Policy Guidelines section).

Radiofrequency ablation may be considered medically necessary for the treatment of Barrett esophagus with low-grade dysplasia, when the initial diagnosis of low-grade dysplasia is confirmed by 2 pathologists. (see Policy Guidelines section).

Radiofrequency ablation is considered investigational for the treatment of Barrett esophagus when the above criteria are not met, including but not limited to Barrett esophagus in the absence of dysplasia.

Cryoablation is considered investigational for the treatment of Barrett esophagus, with or without dysplasia.

Intracranial stent placement may be considered medically necessary as part of the endovascular treatment of intracranial aneurysms for patients when surgical treatment is not appropriate and standard endovascular techniques do not allow for complete isolation of the aneurysm, eg, wide-neck aneurysm (≥4 mm) or a sack-to-neck ratio less than 2:1.

Intracranial flow-diverting stents with U.S. Food and Drug Administration (FDA) approval for the treatment of intracranial aneurysms may be considered medically necessary as part of the endovascular treatment of intracranial aneurysms that meet anatomic criteria (see Policy Guidelines section) and are not amenable to surgical treatment or standard endovascular therapy.

Intracranial stent placement is considered investigational in the treatment of intracranial aneurysms except as noted above.

Intracranial percutaneous transluminal angioplasty with or without stenting is considered investigational in the treatment of atherosclerotic cerebrovascular disease.

The use of endovascular mechanical embolectomy using a device with FDA approval for the treatment of acute ischemic stroke may be considered medically necessary as part of the treatment of acute ischemic stroke for patients who meet all of the following criteria:

Have a demonstrated occlusion within the proximal intracranial anterior circulation (intracranial internal carotid artery, or M1 or M2 segments of the middle cerebral artery, or A1 or A2 segments of the anterior cerebral artery); AND

Can receive endovascular mechanical embolectomy within 12 hours of symptom onset OR within 24 hours of symptom onset if there is evidence of a mismatch between specific clinical and imaging criteria (see Policy Guidelines); AND

Have evidence of substantial and clinically significant neurologic deficits (see Policy Guidelines section); AND

Have evidence of salvageable brain tissue in the affected vascular territory (see Policy Guidelines section); AND

Have no evidence of intracranial hemorrhage or arterial dissection on computed tomography or magnetic resonance imaging.

Endovascular interventions are considered investigational for the treatment of acute ischemic stroke when the above criteria are not met.

Inyecciones intratimpánicas de agentes farmacológicos (ej, dexametasona o latanaprost) para el tratamiento de la enfermedad de Meniere no se considera para pago.
Inyecciones intratimpánicas de agentes farmacológicos (ej. dexametasona) para el tratamiento de pérdida de audición sensorineural, pérdida de audición en condiciones autoinmunes, (ej. Síndrome de Cogan), y otras condiciones inflamatorias del oído medio no se consideran para pago. La razón para esto es que no hay suficiente evidencia médica disponible (estudios no fueron aleatorios) para evaluar los resultados de inyecciones intratimpánicas en el tratamiento de la enfermedad de Meniere. Estudios controlados aleatorios son necesarios para determinar los resultados a largo plazo en esta condición y sus efectos adversos especialmente en el área de pérdida de audición.

Quantitative sensory testing, including but not limited to current perception threshold testing, pressure-specified sensory device testing, vibration perception threshold testing, and thermal threshold testing, is considered investigational.

El uso de la onda de choque extracorpórea en el tratamiento de la enfermedad de Peyronie no se considera para pago. Los estudios realizados son series pequeñas, en distintas etapas de la enfermedad, con diferentes protocolos y con un seguimiento muy corto.

High intensity laser therapy in cases of osteoarthritis, trauma and back pain is not considered for payment. This treatment modality has not been evaluated by the New

Technology Evaluation Committee of the BCBSA. There are also no randomized controlled studies on its long-term efficacy.

Electrodiagnostic assessment, consisting of electromyography, nerve conduction study, and related measures, may be considered medically necessary as an adjunct to history, physical exam, and imaging studieswhen the following criteria are met:

Signs and symptoms of peripheral neuropathy and/or myopathy are present; and
Definitive diagnosis cannot be made by physical exam and imaging studies alone; and
Work-up for one or more of the following categories of disease is indicated (see Policy Guidelines section):
Compressive neuropathies
Nerve root compression
Traumatic nerve injuries
Generalized and focal neuropathies/myopathies
Plexopathies
Motor neuron diseases
Neuromuscular junction disorders.
A repeat electrodiagnostic assessment may be considered medically necessary when at least one of the following criteria has been met:

Development of new symptoms or signs suggesting a second diagnosis in a patient who has received an initial diagnosis; or
Interim progression of disease following an initial test that was inconclusive, such that a repeat test is likely to elicit additional findings; or
Unexpected change(s) in the course of disease or response to treatment, suggesting that the initial diagnosis may be incorrect and that reexamination is indicated.
Electrodiagnostic assessment, consisting of electromyography, nerve conduction study, and related measures, is considered investigational when the above criteria are not met, including but not limited to, the following situations:

Screening of asymptomatic individuals
Serial assessments to evaluate progression of disease in a patient with a previously diagnosed neuropathy or myopathy
Evaluation of treatment response in a patient with previously diagnosed neuropathy or myopathy
Evaluation of disease severity in a patient with previously diagnosed neuropathy or myopathy.

The percutaneous treatment of fracture non-unions of bone defects with the use of bone marrow aspirate with or without demineralized bone matrix is considered investigational.

Dynamic posturography is considered investigational.

Transcranial magnetic stimulation (TMS) of the brain using an FDA-cleared device and modality, which can include but is not limited to, conventional TMS, deep TMS, and theta burst stimulation (see Policy Guidelines) may be considered medically necessary as a treatment of major depressive disorder when all of the following conditions (1 to 3) have been met:

Confirmed diagnosis of severe major depressive disorder (single or recurrent) documented by standardized rating scales that reliably measure depressive symptoms; and

Any one of the following (a, b, c, or d):

Individual has tried and had an inadequate response to 2 antidepressant agents from 2 different antidepressant classes (i.e., selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, tricyclic antidepressants, bupropion, or mirtazapine). An adequate trial of an antidepressant is defined by BOTH of the following:

The trial length was at least 6 weeks at generally accepted doses or of sufficient duration as determined by the treating physician at the generally accepted doses; AND

Individual was ≥80% adherent to the agent during the trial.

Inability to tolerate a therapeutic dose of medications due to distinct side effects; or

History of response to TMS in a previous depressive episode (at least 3 months since the prior episode); or

Is a candidate for electroconvulsive therapy; further, electroconvulsive therapy would not be clinically superior to TMS (eg, in cases with psychosis, acute suicidal risk, catatonia or life-threatening inanition TMS should NOT be used);

and

Failure of a trial of a psychotherapy known to be effective in the treatment of major depressive disorder of an adequate frequency and duration, without significant improvement in depressive symptoms, as documented by standardized rating scales that reliably measure depressive symptoms.

TMS for major depressive disorder that does not meet the criteria listed above is considered investigational.

Continued treatment with TMS of the brain as maintenance therapy is considered investigational.

TMS of the brain is considered investigational as a treatment of all other psychiatric and neurologic disorders, including but not limited to bipolar disorder, schizophrenia, obsessive-compulsive disorder, or migraine headaches.

 

La estimulación sensorial para pacientes en coma no se considera para pago, ya que la evidencia científica disponible es inadecuada para llegar a conclusiones, relacionadas a la efectividad de este tratamiento.

Biofeedback as a treatment of chronic pain, including but not limited to low back pain, is investigational.

Actigraphy is considered investigational when used as the sole technique to record and analyze body movement, including but not limited to its use to evaluate sleep disorders. This does not include the use of actigraphy as a component of portable sleep monitoring (see Policy Guidelines section).

Timpanostomía asistida por láser con inserción de PET se considera para pago en casos de otitis media crónica cuando cumple con los criterios para realizar una timpanostomía convencional con inserción de PET.
Miringotomía asistida por láser (sin inserción de PET) no se considera para pago como tratamiento de otitis media aguda ya que el tratamiento es esencialmente la administración de antibióticos.
Miringotomía asistida por láser (también llamada fenestración de membrana timpánica asistida por láser – LTMF) no se considera para pago como una alternativa a la timpanostomía con inserción de PET.

PUVA se considera para pago en casos de vitíligo y psoriasis severa que no responden a tratamiento conservador (ej. cortisona tópica, preparaciones de brea, y luz ultravioleta).
PUVA se considera para pago para las siguientes condiciones que no hayan respondido a terapia convencional:
Linfoma cutáneo de células T (Mycosis Fungoides)

Manifestaciones cutáneas en “graft versus host disease”

Scleroderma cicircunscrita

Durante la terapia con PUVA el paciente necesita ser evaluado regularmente para determinar la efectividad y desarrollo de efectos adversos de la terapia. Dichas evaluaciones son necesarias para asegurar que la exposición a la dosis de radiación se mantiene en un nivel mínimamente compatible con el control adecuado de la enfermedad. Por tal motivo, Puva no se recomienda para tratamiento en el hogar.

The treatment of active acne by means of laser therapy is not considered for payment. The pilot studies are small, they are not random, nor controlled. The American Academy of Dermatology believes there are no long-term studies.

Note: This policy does not apply to the treatment of laser acne scarring.

La terapia de potenciación con insulina no se considera para pago.
Estudios recientes tienden a sugerir que la insulina potencia el evento bioquímico en la administración de la quimioterapia a corto plazo, pero los efectos y resultados a largo plazo no han sido establecidos. Por lo tanto, estudios adicionales son necesarios para que demuestren beneficios a largo plazo de esta terapia.

Paraspinal surface electromyography is considered investigational as a technique to diagnose or monitor back pain.

El uso del vendaje de calor radiante no se considera para pago.

No existe literatura médica que valide el hecho de que la terapia de heridas con el sistema normo térmico radiante sana cualquier tipo de herida mejor que el tratamiento convencional.

El uso de un stent prostático no se considera para pago en ninguna de las condiciones enumeradas en la definición. No ha sido evaluado, ni aprobado por el FDA.

Individuals with Type 1 Diabetes

Long-term continuous glucose monitoring (CGM) device monitoring of glucose levels in interstitial fluid, as a technique of diabetic monitoring, may be considered medically necessary in individuals with type 1 diabetes who have demonstrated an understanding of the technology, are motivated to use the device correctly and consistently, are expected to adhere to a comprehensive diabetes treatment plan supervised by a qualified provider, and are capable of using the device to recognize alerts and alarms

Short-term CGM monitoring of glucose levels in interstitial fluid may be considered medically necessary in individuals with type 1 diabetes whose diabetes is poorly controlled, despite current use of best practices (see Policy Guidelines section). Poorly controlled type 1 diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia, and recurrent diabetic ketoacidosis.

Short-term CGM monitoring of glucose levels in interstitial fluid may also be considered medically necessary in patients with type 1 diabetes prior to insulin pump initiation to determine basal insulin levels.

Individuals with Type 2 Diabetes

Long-term CGM monitoring of glucose levels in interstitial fluid may be considered medically necessary in individuals with type 2 diabetes who are willing and able to use the device and have adequate medical supervision and who experience significant hypoglycemia on multiple daily doses of insulin or an insulin pump in the setting of insulin deficiency.

Short-term and long-term CGM monitoring of glucose levels in interstitial fluid may be considered medically necessary in individuals with type 2 diabetes who require multiple daily doses of insulin and whose diabetes is poorly controlled, despite current use of best practices (see Policy Guidelines section) and are capable of using devices safely. Poorly controlled type 2 diabetes includes the following clinical situations: unexplained hypoglycemic episodes, hypoglycemic unawareness, persistent hyperglycemia, or hemoglobin A1c (HbA1c) levels above target.

Short-term CGM monitoring of glucose levels in interstitial fluid may be considered medically necessary in individuals with type 2 diabetes who require multiple daily doses of insulin to determine basal insulin levels prior to insulin pump initiation.

Short-term and long-term CGM monitoring of glucose levels in interstitial fluid in individuals with type 2 diabetes not on intensive insulin therapy (i.e., individuals on basal insulin or oral antidiabetic agents only) is considered investigational.

Other uses of long-term and short-term CGM monitoring of glucose levels in interstitial fluid as a technique of diabetic monitoring including use in gestational diabetes are considered investigational.

The use of implantable CGM devices for management of Type 1 and Type 2 diabetes mellitus is considered investigational.

Topical hyperbaric oxygen therapy is considered investigational.

Systemic hyperbaric oxygen pressurization may be considered medically necessary in the treatment of the following conditions:

nonhealing diabetic wounds of the lower extremities in patients who meet the following 3 criteria:

Individual has type 1 or type 2 diabetes and has a lower-extremity wound due to diabetes;

Individual has a wound classified as Wagner grade 3 or higher (see Policy Guidelines section); and

Individual has no measurable signs of healing after 30 days of an adequate course of standard wound therapy;

acute traumatic ischemia (eg, crush injuries, reperfusion injury, compartment syndrome);

decompression sickness;

gas embolism, acute;

cyanide poisoning, acute;

acute carbon monoxide poisoning;

soft-tissue radiation necrosis (eg, radiation enteritis, cystitis, proctitis) and osteoradionecrosis;

pre- and posttreatment for patients undergoing dental surgery (non-implant-related) of an irradiated jaw;

gas gangrene (ie, clostridial myonecrosis);

profound anemia with exceptional blood loss: only when blood transfusion is impossible or must be delayed;

autism spectrum disorder;

chronic refractory osteomyelitis; and

compromised skin grafts or flaps.

Systemic hyperbaric oxygen pressurization is considered investigational in all other situations, including but not limited to, the treatment of the following conditions:

acute osteomyelitis;

bisphosphonate-related osteonecrosis of the jaw;

necrotizing soft tissue infections;

acute thermal burns;

acute surgical and traumatic wounds not meeting criteria specified in the medically necessary statement;

chronic wounds, other than those in patients with diabetes who meet the criteria specified in the medically necessary statement;

spinal cord injury;

traumatic brain injury;

inflammatory bowel disease (Crohn disease or ulcerative colitis);

brown recluse spider bites;

bone grafts;

carbon tetrachloride poisoning, acute;

cerebrovascular disease, acute (thrombotic or embolic) or chronic;

fracture healing;

hydrogen sulfide poisoning;

intra-abdominal and intracranial abscesses;

lepromatous leprosy;

meningitis;

pseudomembranous colitis (antimicrobial agent-induced colitis);

radiation myelitis;

sickle cell crisis and/or hematuria;

demyelinating diseases (eg, multiple sclerosis, amyotrophic lateral sclerosis);

retinal artery insufficiency, acute;

retinopathy, adjunct to scleral buckling procedures in patients with sickle cell peripheral retinopathy and retinal detachment;

pyoderma gangrenosum;

acute arterial peripheral insufficiency;

acute coronary syndromes and as an adjunct to coronary interventions, including but not limited to, percutaneous coronary interventions and cardiopulmonary bypass;

idiopathic sudden sensorineural hearing loss;

refractory mycoses: mucormycosis, actinomycosis, conidiobolus coronato;

cerebral edema, acute;

migraine;

in vitro fertilization;

cerebral palsy;

tumor sensitization for cancer treatments, including but not limited to, radiotherapy or chemotherapy;

delayed-onset muscle soreness;

idiopathic femoral neck necrosis;

chronic arm lymphedema following radiotherapy for cancer;

radiation-induced injury in the head and neck, except as noted earlier in the medically necessary statement;

early treatment (beginning at completion of radiotherapy) to reduce adverse events of radiotherapy;

Bell palsy;

acute ischemic stroke;

motor dysfunction associated with stroke;

herpes zoster;

vascular dementia;

fibromyalgia; and

mental illness (ie, posttraumatic stress disorder, generalized anxiety disorder or depression).

El tratamiento transvaginal por radiofrecuencia para incontinencia urinaria del esfuerzo no se considera para pago.
El tratamiento de incontinencia urinaria al esfuerzo utilizando radiofrecuencia transuretral no se considera para pago.
Los datos publicados en la literatura sobre la suspensión transvaginal de la vejiga es inadecuada para llegar a conclusiones científica sobre su seguridad y eficacia a largo término del procedimiento.

Monitoreo de la circulación cerebral usando electrodos termales no se considera para pago. No hay datos suficientes que permitan llegar a conclusiones sobre el efecto de esta tecnología en los resultados finales.
Empleados federales podrán ser considerados como una excepción si existe un mandato federal y se les evaluara de acuerdo a la necesidad médica.

Tratamiento de la sinusitis crónica o exacerbaciones agudas de la sinusitis crónica con antibióticos en aerosol no se considera para pago. Los cinco estudios publicados en la literatura hasta el 2007 usando este régimen, donde se informa que el tratamiento fue exitoso, no tenían un grupo de control. Esto limita la interpretación de estos resultados.

Prolotherapy is considered investigational as a treatment of musculoskeletal pain.

Impedancia eléctrica en el barrido del seno es un procedimiento que no se considera para pago, ya que una prueba negativa no descarta la posibilidad de un tumor. La impedancia eléctrica no sustituye la biopsia para influenciar en decisiones de tratamiento. Dada la precisión diagnostica de la biopsia y su baja morbilidad esta sigue siendo el estándar de oro de la práctica.

Dermatoscopy, using either direct inspection, digitization of images, or computer-assisted analysis, is considered investigational as a technique to evaluate or serially monitor pigmented skin lesions.

Computer-based optical imaging devices, eg, multispectral digital skin lesion analysis, are considered investigational as a technique to evaluate or serially monitor pigmented skin lesions.

Dermatoscopy and computer-based optical imaging devices are considered investigational for defining peripheral margins of skin lesions suspected of malignancy prior to surgical excision.

Immunotherapy for allergies is considered for payment in patients with hypersensitivity that cannot be managed with the use of medications or avoiding exposure. Injections with the specific allergen are prepared for a patient. The following conditions are considered for payment:

·         Allergic rhinitis

·         Allergic asthma

·         Atopic dermatitis

·         Food allergy

The following methods are not considered for payment:

•  Provocation and neutralization therapy

•  Urine injections

• Emulsion Therapy

Extracorporeal shock wave therapy using either a high- or low-dose protocol or radial extracorporeal shock wave therapy is considered investigational as a treatment of musculoskeletal conditions, including but not limited to plantar fasciitis; tendinopathies including tendinitis of the shoulder, Achilles tendinitis, tendinitis of the elbow (lateral epicondylitis), and patellar tendinitis; stress fractures; avascular necrosis of the femoral head; delayed union and nonunion of fractures; and spasticity.

Lower limb prosthesis complies with Triple-S medical criteria for coverage when the following general criteria are met:

• The patient can reach or maintain a functional state defined by a reasonable period of time;

• The patient is motivated to ambulate; and

• The prosthesis is incident to the services of a physician or ordered by a physician.

The determination of medical criteria for coverage of prostheses is also based on the potential of functional level of the patient:

Key point

According to the National Center for Health Statistics of the U.S. there are approximately 200,000 new amputations in the United States each year. Approximately 70% are amputations of lower limbs.

People with lower limb amputations walk slower and use a less efficient asymmetric gait compared with normal subjects with non-pathological gait. The more proximal the amputations are, the more exacerbated these differences will be.

Functional Levels

The determination of the medical necessity of certain components/additions to the prosthesis is based on potential of functional capabilities of the beneficiary. The potential of functional ability is based on the reasonable expectations of the technician, and medical treatment, considering factors including, but not limited to:

a. The past history of the beneficiary (including the use of prior prosthesis if it proceeds); and

b. Current condition of the beneficiary including the state of the stump and the nature of other medical problems; and

c. The desire of the beneficiary to ambulate.

Clinical evaluations of the potential for rehabilitation of the patient should be based on the following classification levels. Medical records must document the functional capabilities of the patient and his/her expected functional potential, including an explanation of the difference, if that is the case.

Clinical evaluations of rehabilitation potential of the beneficiary should be based on the following classification levels:

Level 0: Does not have the ability or potential to ambulate or transfer securely with or without assistance and prosthesis does not improve his/her quality of life or mobility.

Level 1: Has the ability or potential to use prosthesis for transfer or ambulation on level surfaces at fixed cadence. Typical ambulator: at home either limited or unlimited.

Level 2: Has the ability or potential for ambulation with the ability to traverse environmental barriers of low level, such as curbs, stairs or uneven surfaces. Typical ambulator: limited community.

Level 3: Has the ability or potential for ambulation with variable cadence. Typical ambulator: in the community, has the ability to traverse most of the environmental barriers and may have the need for professional activity, therapeutic activity, or exercise that requires the use of prosthesis beyond simple locomotion.

Level 4: Has the ability or potential for ambulation that exceeds the basic needs of locomotion, which exhibit high levels of impact, stress, or energy. This characteristic is typical of the demands of prosthesis of the child, active adult, or an athlete.

The replacement or repair of parts or prosthesis will have coverage when there is adequate documentation of the functional and/or physiological need such as, but not limited to, changes in the stump, changes in functional need, or an irreparable damage or due to the excessive weight of the patient or demands of prosthesis of very active amputees.

Lower limb prosthesis is covered when the beneficiary:

1. Needs to reach or maintain a defined functional state in a reasonable period of time; and

2. Is motivated to ambulate.

Records must document the capabilities of the current functional beneficiaries and their expected functional potential, including an explanation of the difference, if that is the case. It is recognized, within the functional classification hierarchy, that bilateral amputees If prosthesis is denied as not reasonable or not necessary, related additions will also be denied as not reasonable and not necessary.

When authorizing an initial prosthesis below the knee (L5500) or preparatory prosthesis below the knee (L5510-L5530, L5540), substitutions and/or additions of procedures and prosthetic components are covered in accordance with the assessment at the functional level, except codes L5629, L5638, L5639, L5646, L5647, L5704, L5785, L5962, L5980 which will be denied as not reasonable and not necessary. When a prefabricated preparatory prosthesis is provided below the knee (L5535), substitutions and/or additions of prosthetic procedures are covered according to the functional level assessment, except for codes L5620, L5629, L5645, L5646, L5670, L5676, L5704, L5962, which will be denied as not reasonable and not necessary.

When authorizing an initial prosthesis over the knee (L5505) or a preparatory prosthesis over the knee (L5560-L5580, L5590-L5600) is provided, the substitutions and/or additions of procedures and prosthetic components are covered in accordance with the functional level assessment, except for codes L5610, L5631, L5640, L5642, L5644, L5648, L5705, L5706, L5964, L5980, and L5710-L5780, L5790-L5795, which will be denied as not and not necessary. When providing a prefabricated preparatory prosthesis over the knee (L5585), the substitution and/or additions of procedures and prosthetic components are covered in accordance with the functional level assessment, except for codes L5624, L5631, L5648, L5651, L5652, L5705, L5706, L5964, and L5966 which will be denied as not reasonable and not necessary.

In the following sections, the determination of coverage for prosthetics and components selected with respect to the potential functional levels represents the usual case. Exceptions will be considered on an individual case if additional documentation is included that justifies the medical necessity. The prosthesis will be denied as not reasonable and not necessary if the potential functional level of the beneficiary is of 0.

Feet

A determination of the type of foot for the prosthesis will be made by the treating physician and/or the prosthesis technician in accordance with the functional needs of the beneficiary. Basic lower extremity prostheses include a SACH Foot. Other prosthetic feet are considered for the coverage based on the functional classification.

A SACH foot external keel (L5970) or ankle/foot of a single axis (L5974) is covered for beneficiaries whose functional level is 1 or higher.

A foot flexible-keel (L5972) or ankle/multiaxial foot (L5978) is covered for those beneficiaries whose functional level is 2 or higher.

A system of ankle and foot controlled by a microprocessor (L5973), with energy storage (L5976), dynamic response foot with multi-axial ankle (L5979), flex feet system (L5980), flex-a system for foot or equal (L5981), or shank foot system with vertical loading pylon (L5987) is covered for beneficiaries whose functional level is 3 or higher.

The coverage extends only if there is sufficient clinical documentation of functional need of the technological function, or the design of a given type of foot. This information of the prosthesis must be documented and retained in the archives of the physician.

A heel of adjustable height by the user (L5990) will be denied as not reasonable and necessary. The basic prosthesis of lower extremity includes only one axis and the constant friction knee. Other prosthetic knees are considered for the coverage on the basis of the functional classification.

A framework of control of high activity knee (L5930) is covered for beneficiaries whose functional level is 4.

The pneumatic knee or electronic knee is covered (L5610, L5613, L5614, L5722-L5780, L5814, L5822-L5840 – L5848, L5856, L5857, L5858) for beneficiaries whose functional level is 3 or higher.

Other knee systems are covered (L5611, L5616, L5710-L5718, L5810-L5812, L5816, L5818) for those beneficiaries whose functional level is 1 or higher.

Ankle

A unit of axial rotation (L5982-L5986) is covered for beneficiaries whose functional level is 2 or higher.

Hips

A polycentric hip joint, pneumatic or hydraulic (L5961) is covered for beneficiaries whose functional level is 3 or higher.

Bases

More than 2 testing sockets (diagnostic) (L5618-L5628) for an individual prosthesis are not reasonable and necessary unless there is documentation justifying the need. Exception: A test plug is not reasonable and necessary for an immediate prosthesis (L5400-L5460).

Aquellos aparatos que se utilizan después de una corrección quirúrgica o mecánica de las desviaciones, deformidades y fracturas en general.
Política
Aparatos ortopédicos que se consideran para pago:
Botas de infante que previenen una desviación o deformidad del pie.

Zapatos terapéuticos para pacientes de diabetes que previenen una amputación.

Andadores, bastones y muletas

I. Prótesis e implantes quirúrgicos que se consideran para pago:
A. Prótesis
Articulaciones artificiales para reparar la articulación o reconstruirla

Lentes intraoculares

Prótesis de mama (incluyendo el sostén)

Marcapasos cardiaco, atómicos o electrónicos

Aparatos maxilofaciales que reemplacen parte de la oreja o la nariz

Prótesis de Pene, cuando la impotencia resulta como producto de trauma o enfermedad

B. Implantes
Implantes Cocleares

Deflux, Hyalgan y Synvisc

Dispositivos para reemplazar el esfínter de la uretra en casos de incontinencia urinaria.

Placas, tornillos, clavos, (herrajería) para cirugías espinales, o musculoesqueletal.

Válvulas cardiacas, Stent

II. Prótesis no quirúrgicas que se consideran para pago:
Ojos Artificiales

Extremidades Artificiales o parte de ellas

Dispositivos que faciliten el habla

Sistema de almacenar orina en casos de incontinencia urinaria permanente

Sistema de colección y retención en casos de colostomía

Patient-controlled end range of motion stretching devices are considered investigational.

Use of a powered exoskeleton for ambulation in patients with lower-limb disabilities is considered investigational.

Orthotic devices are considered medically necessary when prescribed by a qualified provider to be used for therapeutic support, protection, restoration, or function for an impaired body part.

Orthotic devices include:

· braces for leg, arm, neck, back, and shoulder;

· corsets for back or for use after special surgical procedures;

· splints for extremities;

· trusses.

The use of Freespira is considered investigational for all indications including treatment of panic disorder and/or post traumatic stress disorder.

The use of NightWare is considered investigational for all indications including treatment of nightmare disorder or nightmares from PTSD.

Surgical medical supplies or materials are considered for payment if they meet the following criteria.

• Items whose primary function is to serve a medical purpose.

• Are ordered and documented as essential in the patient’s care plan.

• They are not necessary in the absence of illness or trauma.

• They are disposable items.

Examples of these materials or supplies are, but not limited to:

1. sterile gloves, eye patches, sterile solutions

2. lines for IV, bandages for wound care

3. sterile gauze, urinary catheter (foley), nasogastric

4. colostomy bag, gloves and nasotracheal suction catheter

Initiation of Powered Negative Pressure Wound Therapy

An initial therapeutic trial of not less than 2 weeks using a powered negative pressure wound therapy (NPWT) system, as part of a comprehensive wound care program that includes controlling factors (eg, diabetes, nutrition, relief of pressure), may be considered medically necessary in the following indications:

Chronic (>90 days) stage III or IV pressure ulcers that have failed to heal despite optimal wound care when there is high-volume drainage that interferes with healing and/or when standard dressings cannot be maintained due to anatomic factors; OR

Wounds in patients with underlying clinical conditions that are known to negatively impact wound healing, which are nonhealing (at least 30 days), despite optimal wound care. (Examples of underlying conditions include, but are not limited to diabetes, malnutrition, small vessel disease, and morbid obesity. Malnutrition, while a risk factor, must be addressed simultaneously with the NPWT.); OR

Traumatic or surgical wounds where there has been a failure of immediate or delayed primary closure.

Continuation of Powered NPWT

Continuation of the powered NPWT system, as part of a comprehensive wound care program, may be considered medically necessary following an initial 2-week therapeutic trial if the treatment trial has resulted in documented objective improvements in the wound, and if there is an ongoing objective improvement during subsequent treatment. Objective improvements in the wound should include the development and presence of healthy granulation tissue, progressive wound contracture and decreasing depth, and/or the commencement of epithelial spread from the wound margins.

Continuation of the powered NPWT system is considered investigational when any of the following occurs:

The therapeutic trial or subsequent treatment period has not resulted in documented objective improvement in the wound, OR

The wound has developed evidence of wound complications contraindicating continued NPWT, OR

The wound has healed to the extent that either grafting can be performed or the wound can be anticipated to heal completely with other wound care treatments.

Therapeutic trials of powered NPWT systems for the treatment of other acute or chronic wounds except as noted above are considered investigational.

Use of single-use NPWT systems (powered or nonpowered)is considered investigational for the treatment of acute or chronic wounds, including but not limited to diabetic, venous, surgical, and traumatic wounds.

La nutrición parenteral se considera para pago si cumple con los siguientes criterios.
Pacientes con patologías severas del tracto digestivo, que le impiden la absorción de suficientes nutrientes para mantener el peso y la fortaleza proporcionales a su condición general. Algunas condiciones pueden ser:

Enfermedad de Crohn
Diarrea intratable
Enterocolitis necrótica
Omfalocele
Atresia intestinal masiva
Obstrucción por estrechez o tumor del esófago o estómago
Pérdida del mecanismo para tragar por el sistema nervioso central
Mala absorción secundarias a fístulas enterocolíticas, enterovesicales o enterocutáneas (en estos casos la nutrición parenteral es temporera en lo que la fístula se recobra)
Síndrome del Intestino Corto
Pacientes con ileo paralitico después de cirugía mayor o por multiple trauma o herida
Infantes y niños pequeños con retraso en el desarrollo debido a enfermedad sistémica o secundario a insuficiencia intestinal por malabsorción, diarrea crónica idiopatica, síndrome de intestino corto
La aprobación del beneficio será caso a caso y se reevaluará en intervalos periódicos que serán determinados de acuerdo a la condición individual del paciente (no se recomienda intervalos mayores de tres (3) meses.

El paciente debe tener un estado de desnutrición manifestado por:

Pérdida significativa de peso comparado con su peso pre-enfermedad y este a su vez comparado con las tablas de peso ideal basadas en edad y altura del paciente.

Albúmina sérica menos de 2.5gm

BUN < de 10mg Nivel de fósforo < de 2.5mg (normal 3 a 4.5 mg) Una solución hipertónica adecuada con propiedades nutrientes consiste de glucosa, aminoácidos, electrolitos, vitaminas, minerales y en ocasiones grasas. Esta solución se administra usando una bomba de infusión para asegurar un flujo continuo de la solución en un itinerario de 24 horas o intermitente. El uso de este último requiere un “Heparin Lock” para prevenir coagulación en el catéter.

La nutrición enteral se considera para pago si cumple con los siguientes criterios:
Inhabilidad anatómica para tragar debido por ejemplo cancer de cabeza y cuello o un tumor que causa obstrucción o estrechez en el esófago o en el estomago.

Pacientes con patologías severas de las estructuras que no permiten obtener o pasar alimento a través del tracto digestivo, lo cual impide mantener el peso y la fortaleza proporcional a la condición general del paciente.

Enfermedad del sistema nervioso central que produce interferencia con la coordinación de la masticación y reagado y existe el riesgo de aspiración.

Proveer documentación suficiente (expediente, hallazgos clínicos) que permita llegar a conclusiones independientes de los beneficios de la nutrición enteral y la necesidad médica de ésta. Toda esta documentación es en adición a las órdenes.

La aprobación del beneficio serán determinados de acuerdo a la condición individual del paciente (no se recomiendan intérvalos mayores de tres (3) meses.

Documentación médica y evidencia suficiente para establecer la necesidad médica de una bomba cuando ésta sea ordenada. Por ejemplo, alimento por gravedad no es satisfactorio por aspiración, diarrea, “dumping síndrome”, etc.

Se cubrirá el modelo más simple que cumpla con los criterios de necesidad médica establecidos para el paciente.
Pérdida de mecanismo para tragar por daños al sistema nerviosos central, con alto riesgo de aspirar.
Recesiones masivas del intestino delgado.
Fistulas traqueosofágicas

Este certificado debe presentarse en el momento de solicitar servicios de nutrición enteral y/o parenteral.
Limitación
La alimentación parenteral y enteral debe ser autorizado por el Programa de Manejo de Caso.

Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for urinary incontinence is considered investigational.

Electrical or magnetic stimulation of the pelvic floor muscles (pelvic floor stimulation) as a treatment for fecal incontinence is considered investigational.

Postsurgical home use of limb compression devices for VTE prophylaxis may be considered medically necessary in individuals with a contraindication to pharmacologic agents (see Policy Guidelines), in the following situations:

After major orthopedic surgery (total hip arthroplasty, total knee arthroplasty, hip fracture surgery); OR

After major nonorthopedic surgery or other orthopedic procedures in individuals who are at moderate or high risk of VTE (see Policy Guidelines).

Postsurgical home use of limb compression devices for VTE prophylaxis for periods longer than 30 days postsurgery is considered investigational.

Postsurgical home use of limb compression devices for venous thromboembolism (VTE) prophylaxis is considered investigational in all other situations, including but not limited to:

After major orthopedic surgery (total hip arthroplasty, total knee arthroplasty, hip fracture surgery) in individuals without a contraindication for anticoagulation; OR

After major nonorthopedic surgery or other orthopedic procedures in individuals without a contraindication for anticoagulation who are at moderate or high risk of VTE (see Policy Guidelines).

Interferential current stimulation is considered investigational.

Circulating and noncirculating cooling devices are considered investigational.

Combination circulating cooling and compression (cryopneumatic) devices are considered investigational.

Tumor treating fields therapy to treat glioblastoma multiforme (GBM) is considered medically necessary as an adjunct to standard maintenance therapy with temozolomide in individuals with newly diagnosed GBM following initial treatment with surgery, radiotherapy, and/or chemotherapy under the following conditions:

Individuals ≥18 years of age,

Supratentorial tumor,

Karnofsky Performance Status score ≥70%,

Individual understands device use, including the requirement for a shaved head, and is willing to comply with use criteria according to the U.S. Food and Drug Administration label (see Policy Guidelines).

Tumor treating fields therapy is considered investigational in all other conditions, including but not limited to the following situations:

As an adjunct to standard medical therapy (eg, bevacizumab, chemotherapy) for individuals with progressive or recurrent GBM,

As an alternative to standard medical therapy for individuals with progressive or recurrent GBM,

For brain metastases,

For cancer in areas other than the brain,

As an adjunct to standard medical therapy (pemetrexed and platinum-based chemotherapy) for individuals with malignant pleural mesothelioma.

Use of a U.S. Food and Drug Administration (FDA) cleared or approved automated insulin delivery system (artificial pancreas device system) with a low-glucose suspend feature may be considered medically necessary in individuals with type 1 diabetes who meet all of the following criteria:

Age 6 years and older AND

Glycated hemoglobin level between 5.8% and 10.0%;

Used insulin pump therapy for more than 6 months;

At least 2 documented nocturnal hypoglycemic events in a 2-week period.

Use of a FDA cleared or approved automated insulin delivery system (artificial pancreas device system) designated as a hybrid closed-loop insulin delivery system (with low glucose suspend and suspend before low features) may be considered medically necessary in individuals with type 1 diabetes who meet all of the following criteria:

Over age 6 years AND

Glycated hemoglobin level between 5.8% and 10.0%;

Used insulin pump therapy for more than 6 months;

At least 2 documented nocturnal hypoglycemic events in a 2-week period.

OR

Age 2 to 6 years AND

Clinical diagnosis of type 1 diabetes for 3 months or more;

Used insulin pump therapy for more than 3 months;

Glycated hemoglobin level <10.0%; Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units. Use of a FDA cleared or approved automated insulin delivery system (artificial pancreas device system) designated as a closed-loop insulin delivery system may be considered medically necessary in individuals with type 1 diabetes who meet all of the following criteria: Age 6 years and older AND Clinical diagnosis of type 1 diabetes for 12 months or more; Using insulin for at least 12 months; Diabetes managed using the same regimen (either pump or multiple daily injections, with or without continuous glucose monitoring) for 3 months or longer. Use of an automated insulin delivery system (artificial pancreas device system) is investigational for individuals who do not meet the above criteria. Use of an automated insulin delivery system (artificial pancreas device system) not cleared or approved by the FDA is investigational.

Criteria for the Management of Anti-Hemophilic Factors
1. The prescription must be written by a hematologist.
2. Anti-hemophiliac factors will be covered for indications approved by the FDA (refer to Table 1).

Home cardiorespiratory monitoring may be considered medically necessary when initiated in infants younger than 12 months of age in the following situations (see Policy Guidelines):

Those with tracheostomies or anatomic abnormalities that make them vulnerable to airway compromise; OR

Those with neurologic or metabolic disorders affecting respiratory control, including central apnea and apnea of prematurity; OR

Those with chronic lung disease (ie, bronchopulmonary dysplasia; see Policy Guidelines).

Home cardiorespiratory monitoring is considered investigational when used as a strategy to reduce the risk of Sudden Infant Death Syndrome (SIDS).

Home cardiorespiratory monitoring is considered investigational when used for cardiopulmonary evaluation in lower-risk infants following a brief resolved unexplained event (BRUE), which was previously known as an apparent life threatening event (ALTE) (see Policy Guidelines for further discussion of BRUE risk).

Home cardiorespiratory monitoring in all other conditions, including but not limited to, the diagnosis of obstructive sleep apnea, is considered investigational.

Use of an oscillatory positive expiratory pressure device may be considered medically necessary in patients with hypersecretory lung disease (ie, produce excessive mucus) who have difficulty clearing the secretions and recurrent disease exacerbations.

High-frequency chest wall compression devices and intrapulmonary percussive ventilation devices may be considered medically necessary in patients with cystic fibrosis or chronic diffuse bronchiectasis as determined by specific criteria (see Policy Guidelines section) (including chest computed tomography scan) when standard chest physical therapy has failed or standard chest physical therapy is unavailable or not tolerated. In considering the chest wall compression and intrapulmonary percussive ventilation devices, there should be demonstrated need for airway clearance. There should also be documented failure of standard treatments (ie, the patient has frequent severe exacerbations of respiratory distress involving inability to clear mucus despite standard treatment [chest physical therapy and, if appropriate, use of an oscillatory positive expiratory pressure device] or valid reasons why standard treatment cannot be performed, such as inability of the caregiver to perform it).

Other applications of high-frequency chest wall compression devices and intrapulmonary percussive ventilation devices, including, but not limited to, their use in patients with cystic fibrosis or chronic diffuse bronchiectasis other than as specified above, their use as an adjunct to chest physical therapy, and their use in other lung diseases such as chronic obstructive pulmonary disease or respiratory conditions associated with neuromuscular disorders, are considered investigational.

At-home monitoring of chronic warfarin therapy may be considered medically necessary in patients who require continuous anticoagulation use for long term (>6 months) or life – long coagulation for any of the following chronic medical conditions:

Mechanical heart valves
Chronic atrial fibrillation
Venous thromboembolism inclusive of deep vein thrombosis (DVT) and pulmonary embolism
Ventricular Assist Devices (VAD)
Hypercoagulable states
All the following criteria must be met for home PT/INR Monitoring:

The device must be Food and Drug Administration – approved
The patient must have been anticoagulated for at least 3 months prior to use of the home INR device;and,
The patient must undergo a face-to-face educational program on anticoagulation management and must have demonstrated the correct use of the device prior to its use in the home; and,
The patient continues to correctly use the device in the context of the management of the anticoagulation therapy following the initiation of home monitoring; and,
The expected need for home INR testing is 6 or more months;
Self-testing with the device should not occur more frequently than once a week.
The use of home monitoring during the initial treatment period is considered investigational.

Testing more frequently than once per week is generally considered investigational.

Myoelectric upper-limb prosthetic components may be considered medically necessary when the following conditions are met:

The patient has an amputation or missing limb at the wrist or above (eg, forearm, elbow); and

Standard body-powered prosthetic devices cannot be used or are insufficient to meet the functional needs of the individual in performing activities of daily living; and

The remaining musculature of the arm(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic device; and

The patient has demonstrated sufficient neurologic and cognitive function to operate the prosthesis effectively; and

The patient is free of comorbidities that could interfere with function of the prosthesis (eg, neuromuscular disease); and

Functional evaluation indicates that with training, use of a myoelectric prosthesis is likely to meet the functional needs of the individual (eg, gripping, releasing, holding, coordinating movement of the prosthesis) when performing activities of daily living. This evaluation should consider the patient’s needs for control, durability (maintenance), function (speed, work capability), and usability.

Advanced upper-limb prosthetic components with both sensor and myoelectric control (e.g., LUKE Arm) are considered investigational.

A prosthesis with individually powered digits, including but not limited to a partial hand prosthesis, is considered investigational.

Myoelectric controlled upper-limb orthoses are considered investigational.

Myoelectric upper-limb prosthetic components are considered investigationalunder all other conditions.

Electrical or electromagnetic stimulation is considered investigational for the treatment of osteoarthritis or rheumatoid arthritis.

Use of an adjustable cranial orthosis may be considered medically necessary following cranial vault remodeling surgery for synostosis.

Use of an adjustable cranial orthosis for synostosis in the absence of cranial vault remodeling surgery is considered investigational.

Use of an adjustable cranial orthosis as a treatment of persistent plagiocephaly or brachycephaly without synostosis may be considered medically necessary when all of the following conditions have been met:

the individual is between 3 and 18 months old

documented failure of conservative therapy (repositioning and physical therapy) of at least 2 months duration

the individual has a cephalic index that is at least two standard deviations above or below the mean for the appropriate gender and age.

Use of an adjustable cranial orthosis is considered investigational for all other indications not outlined above.

(See below for discussion of use of an adjustable cranial orthosis as a reconstructive service.)

Use of continuous passive motion in the home setting may be considered medically necessary as an adjunct to physical therapy in the following situations:

Under conditions of low postoperative mobility or inability to comply with rehabilitation exercises following a total knee arthroplasty (total knee arthroplasty) or total knee arthroplasty revision. This may include

dystrophy); extensive arthrofibrosis or tendon fibrosis; or physical, mental, or behavioral inability to participate in active physical therapy.

During the non-weight-bearing rehabilitation period following articular cartilage repair procedures of the knee (eg, microfracture, osteochondral grafting, autologous chondrocyte implantation, treatment of osteochondritis dissecans, repair of tibial plateau fractures).

Use of continuous passive motion in the home setting for all other conditions is considered investigational.

Mechanical insufflation-exsufflation (MI-E) may be considered medically necessary in patients with neuromuscular disease or spinal cord injury and impaired ability to cough and who require ventilatory assistance.

Transtympanic micropressure applications as a treatment of Meniere disease are considered not medically necessary.

El uso de bombas de infusión externa se considera para pago para la administración de los siguientes medicamentos:
Morfina y otros analgésicos parenterales para el tratamiento de dolor crónico de cáncer y que es resistente a terapia convencional.

Heparina para el tratamiento de eventos tromboembólicos severos que no pueden manejarse con tratamiento convencional por vía subcutánea o intravenosa.

Quimioterapia vía intravenosa en casos de cáncer.

La selección de pacientes para esta modalidad de tratamiento debe cumplir con las siguientes condiciones:
Paciente ambulatorio que se pueda adaptar a esta modalidad y demuestre un mejoramiento en su calidad de vida.

Que el paciente obtenga un mejor tratamiento con una infusión continua en vez de terapia intermitente.

Paciente al cual se le hace difícil cumplir con inyecciones intermitentes, y el cual es fácil educar en este sistema, y que pueda reaccionar favorablemente en caso de ocurrir una emergencia.

Quimioterapia en casos de cáncer en el hogar por vía intravenosa o a través de un portal se limita única y exclusivamente a infusiones de 24 horas de 5-fluorouracil.

Esta quimioterapia debe ser ordenada por un oncólogo y supervisada por una enfermera adiestrada en oncología.

Low-intensity pulsed ultrasound is considered investigational as a treatment of fresh fractures (surgically managed or nonsurgically managed).

Low-intensity pulsed ultrasound is considered investigational as a treatment of fracture nonunion and delayed union fractures.

Low-intensity pulsed ultrasound is considered investigational as a treatment of stress fractures, osteotomy, and distraction osteogenesis.

 

Use of the EIP for the administration of the following drugs is considered medically necessary for selected patients on:

morphine and other parenteral analgesics for treatment of severe, chronic cancer pain  that is resistant to conventional therapy. Acceptable routes are subcutaneous (SC) andintravenous (IV);
insulin for treatment of insulin-dependent diabetes mellitus in patients who cannot be controlled by intermittent dosing. Acceptable routes are SC and IV;
heparin for treatment of severe thromboembolic disease that cannot be managed conventionally(e.g., complicated pregnancy). Acceptable routes are SC and IV;
chemotherapeutics for treatment of cancer. Acceptable routes are stipulated in the drug labelingand might include either IV or intra-arterial (IA).

Equipo Medico Duradero “standard” (DME) es aquel que cumple con los siguientes requisitos:
Se usan principal y comúnmente para servir a un propósito médico.

Son útiles a las personas con enfermedad o lesión.

Los ordena o prescribe un médico.

Se pueden usar sucesivamente por otros pacientes.

Se usan principalmente en el hogar.

No son diseñados para proveer confort o conveniencia.

No es útil a persona alguna en ausencia de trauma o enfermedad.

Esta aprobado por FDA (donde aplique) y se considera seguro y efectivo para el propósito diseñado.

Skin contact monochromatic infrared energy is considered investigational as a technique to treat cutaneous ulcers, diabetic neuropathy, and musculoskeletal conditions, including but not limited to temporomandibular disorders, tendonitis, capsulitis, and myofascial pain.

Estimulación eléctrica al umbral como tratamiento de desórdenes de movimiento, incluyendo pero no limitándose a perlesía cerebral, no se considera para pago. Estudios realizados hasta enero de 2008 demuestran que esta tecnología no ha evidenciado un efecto terapéutico significativo en la función motora, arco de movilidad o tamaño muscular.

No se consideran para pago artículos costosos o de lujo por:
Razones estéticas o de comodidad
Que añadan conveniencia que no se relacione con el tratamiento o condición individual por la que el paciente necesita el cuidado
Limitación
Si el paciente desea las características «lujosos o costosos», el pago de Triple-S estará basado en la tarifa del servicio que normalmente alcanzaría el propósito establecido en el tratamiento (ejemplo: artículo estándar) del paciente.

El Manejador de Caso determina que el pago por un artículo o característica costosa es razonablemente necesario cuando dicho gasto es para añadir o cumplir con la necesidad médica del tratamiento. Un ejemplo de esto es, una silla motorizada para un paciente en condiciones de debilidad o inmovilidad tal que no puede operar una silla de ruedas manual.

El rechazo o aprobación de cubierta estará basado no solo en inferencias sobre pacientes con diagnósticos similares o datos relacionados de utilización general, también estará basada en la consideración de evidencia clínica y objetiva relacionada al cuidado individual del paciente.


Los suministros de equipo y accesorios necesarios para el funcionamiento efectivo del equipo médico duradero son aquellos que cumplen con los siguientes requisitos:
Se usan principalmente y comúnmente para servir a un propósito médico, ya que son útiles a las personas con enfermedad o lesión.
Los ordena o prescribe un médico.
No se deben usar repetidamente.
Por su naturaleza, usualmente son desechables.

Los suministros de equipo y accesorios necesarios para el funcionamiento efectivo del equipo médico duradero son aquellos que cumplen con los siguientes requisitos:
Se usan principalmente y comúnmente para servir a un propósito médico, ya que son útiles a las personas con enfermedad o lesión.
Los ordena o prescribe un médico.
No se deben usar repetidamente.
Por su naturaleza, usualmente son desechables.