Endobronchial brachytherapy may be considered medically necessary in the following clinical situations:

In individuals with primary endobronchial tumors who are not otherwise candidates for surgical resection or external-beam radiotherapy due to comorbidities or location of the tumor.

As a palliative therapy for airway obstruction or severe hemoptysis in individuals with primary, metastatic, or recurrent endobronchial tumors.

Other applications of endobronchial brachytherapy are investigational including, but not limited to, its use as a radiation «boost» to curative external-beam radiotherapy, as a treatment for asymptomatic recurrences of non-small cell lung cancer, or in the treatment of hyperplastic granulation tissue.

Outpatient cardiac rehabilitation programs may be considered medically necessary for individuals with a history of the following conditions and procedures:

·         acute myocardial infarction (heart attack) within the preceding 12 months;

·         coronary artery bypass graft surgery;

·         percutaneous transluminal coronary angioplasty or coronary stenting;

·         heart valve surgery;

·         heart or heart-lung transplantation;

·         current stable angina pectoris; or

·         compensated heart failure.

Repeat participation in an outpatient cardiac rehabilitation program in the absence of another qualifying cardiac event is considered investigational.

Intensive cardiac rehabilitation with the Ornish Program for Reversing Heart Disease, Pritikin Program, or Benson-Henry Institute Program is considered investigational.

Virtual cardiac rehabilitation is considered investigational.

Hippotherapy is considered investigational.

Neuromuscular stimulation is considered investigational as a technique to restore function following nerve damage or nerve injury. This includes its use in the following situations:

To provide upper-extremity function in patients with nerve damage (eg, spinal cord injury or poststroke); or
To improve ambulation in individuals with foot drop caused by congenital disorders (eg, cerebral palsy) or nerve damage (eg,poststroke, or in those with multiple sclerosis); or
As a technique to provide ambulation in patients with spinal cord injury.

Functional electrical stimulation devices for exercise in patients with spinal cord injury is considered investigational.

Non-computer-assisted corneal topography is considered part of the evaluation and management services of general ophthalmologic services (CPT codes 92002-92014), and therefore this service should not be billed separately. There is no separate CPT code for this type of corneal topography.

Computer-assisted corneal topography is considered investigational to detect or monitor diseases of the cornea.

Endothelial keratoplasty (Descemet stripping endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty, Descemet membrane endothelial keratoplasty, or Descemet membrane automated endothelial keratoplasty) may be considered medically necessary for the treatment of endothelial dysfunction, including but not limited to:

ruptures in Descemet membrane,

endothelial dystrophy,

aphakic and pseudophakic bullous keratopathy,

iridocorneal endothelial syndrome,

corneal edema attributed to endothelial failure,

and failure or rejection of a previous corneal transplant.

Femtosecond laser-assisted endothelial keratoplasty or femtosecond and excimer laser-assisted endothelial keratoplasty are considered investigational.

Endothelial keratoplasty is considered investigational when endothelial dysfunction is not the primary cause of decreased corneal clarity.

El tratamiento de la degeneración macular con colocación de Retaane en el área yuxtoescleral posterior no se considera para pago, ya que el medicamento aún no ha sido aprobado por FDA ni existen estudios sobre el resultado del tratamiento a largo plazo.
Alcon, fabricante de Retaane, no tiene intenciones inmediatas de continuar estudios sobre el uso de Retaane para el tratamiento de la degeneración macular relacionada a la edad.

Hospice services are considered for payment if they meet the following criteria:

1.     Physician certifies in writing that the patient is terminally ill and with a life expectancy of   6 months or less.

2.     Patient receives hospice care at home.

3.     Hospice care program offered by a   Triple-S provider

4.     Services included in the perdiem are the following:

a.     House keeper

b.     Health assistant

c.     Grief assistance

d.     Spiritual counseling

e.     Nursing

f.      Dietitian and nutrition counseling

g.     Durable medical equipment

h.     Acute Pain medicine (not maintenance)

i.      Medical supplies

j.      Social worker

This service does not limit insured’s free choice for hospital coverage as long as there is a medical necessity and admission criterion.

El médico consultor puede iniciar servicios diagnósticos y/o terapéuticos.
La necesidad de consulta por el médico de cabecera, debe estar documentada en el expediente clínico del paciente. La opinión del médico consultor, así como cualquier servicio ordenado o prestado debe estar documentado en el expediente del paciente.

Debe existir documentación que demuestre que el resultado de la consulta le fue comunicado al médico de cabecera.

Referir o transferir el cuidado a otro médico no constituye una consulta.

Una consulta iniciada por el paciente o un familiar y no requerido por el médico de cabecera no se facturará con los códigos de consulta y sí como visitas de oficina.

Las consultas telefónicas con otro médico no constituyen una consulta.

La consulta confirmatoria requerida por Triple-S debe facturarse usando los códigos descritos en la sección de Evaluación y Manejo del CPT (99241 al 99245 oficina y sala de emergencia) utilizando el modificador 032.

Hay códigos de procedimientos que son parte de la evaluación y manejo. Por lo que estos últimos no se pagan por separado.

Si el médico consultor asume, subsiguientemente, el cuidado del paciente o parte del tratamiento, no debe usar los códigos de consultas. Se deben de usar los códigos de visitas subsiguientes apropiados, según sea el caso.

Los códigos de consulta de hospital, se facturan una vez por admisión. Todo servicio subsiguiente durante la hospitalización debe facturarse con los códigos de visita subsiguiente, incluyendo servicios para completar la consulta inicial, monitoreo del progreso, revisión de recomendaciones o tratar un problema nuevo.

Use of baroreflex stimulation implanted devices is considered investigational in all situations, including but not limited to treatment of hypertension and heart failure.

Intradialytic parenteral nutrition as an adjunct to hemodialysis may be considered medically necessary when it is offered as an alternative to a regularly scheduled regimen of total parenteral nutrition only in individuals who would be considered candidates for total parenteral nutrition (see Policy Guidelines).

Intradialytic parenteral nutrition is considered investigational in individuals who would be considered a candidate for total parenteral nutrition, but for whom intradialytic parenteral nutrition is not offered as an alternative to total parenteral nutrition, but in addition to regularly scheduled infusions to total parenteral nutrition.

Intradialytic parenteral nutrition as an adjunct to hemodialysis is considered investigational in individuals who would not otherwise be considered candidates for total parenteral nutrition.

Autologous hematopoietic cell transplantation may be considered medically necessary as salvage therapy of chemosensitive Waldenström macroglobulinemia.

Allogeneic hematopoietic cell transplantation is considered investigational to treat Waldenström macroglobulinemia.

Use of any focal therapy modality to treat individuals with localized prostate cancer is investigational.

The use of dry hydrotherapy massagers for the treatment of chronic pain conditions is considered investigational.

Low-density lipoprotein (LDL) apheresis may be considered medically necessary in patients with homozygous familial hypercholesterolemia as an alternative to plasmapheresis.

LDL apheresis may be considered medically necessary in patients with heterozygous familial hypercholesterolemia who have failed diet therapy and maximum tolerated combination drug therapy (see Policy Guidelines section) AND who meet the following U.S. Food and Drug Administration approved indications (all LDL levels represent the best achievable LDL level after a program of diet and drug therapy):

Functional hypercholesterolemic heterozygotes with LDL ≥300 mg/dL

Functional hypercholesterolemic heterozygotes with LDL ≥200 mg/dLa AND documented coronary artery disease.a

LDL apheresis is considered investigational for other uses, including nonfamilial hypercholesterolemia, nephrotic syndrome, sudden sensorineural hearing loss, severe diabetic foot ulcerations, peripheral artery disease, preeclampsia, non-arteritic acute anterior ischemic optic neuropathy, and acute coronary syndrome.

Therapeutic apheresis with selective high-density lipoprotein delipidation and plasma reinfusion is considered investigational for all indications, including but not limited to acute coronary syndrome.

a For definitions of maximum tolerated drug therapy and documented coronary artery disease, see the Policy Guidelines section.

Psychological coping therapy including cognitive-behavioral therapy, self-help cognitive-behavioral therapy, tinnitus coping therapy, acceptance and commitment therapy, and psychophysiological treatment, may be considered medically necessary for persistent and bothersome tinnitus.

Treatment of tinnitus with any of the following therapies is considered investigational:

biofeedback

tinnitus maskers, customized sound therapy

combined psychological and sound therapy (eg, tinnitus retraining therapy)

transcranial magnetic stimulation,

transcranial direct current stimulation

electrical transcutaneous electrical stimulation of the ear, electromagnetic energy

transmeatal laser irradiation.

Note: This policy does not address surgical (eg, cochlear or brainstem implants) or pharmacologic (eg, use of amitriptyline or other tricyclic antidepressants) treatments of tinnitus, or injection of botulinum toxin.

The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention in individuals with atrial fibrillation undergoing open or thoracoscopic cardiac procedures is considered investigational.

The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention as a stand-alone procedure for stroke prevention in individuals with atrial fibrillation is considered investigational.

Fluoride varnish is considered medically necessary to help reduce the risk of decayed, missing, or filled primary teeth in preschool children and early adulthood.

The identification and subsequent treatment of chronic cerebrospinal venous insufficiency in patients with multiple sclerosis is considered not medically necessary.

The use of extracorporeal membrane oxygenation (ECMO) may be considered medically necessary for the management of adults with acute respiratory failure when all of the following criteria are met:

Respiratory failure is due to a potentially reversible etiology (see Policy Guidelines section) AND

Respiratory failure is severe, as determined by one of the following:

A standardized severity instrument such as the Murray score (see Policy Guidelines section); OR

One of the criteria for respiratory failure severity outlined in the Policy Guidelines. AND

None of the following contraindications are present:

High ventilator pressure (peak inspiratory pressure >30 cm H2O) or high fraction of inspired oxygen (>80%) ventilation for more than 168 hours;

Signs of intracranial bleeding;

Multisystem organ failure;

Prior (ie, before onset of need for ECMO) diagnosis of a terminal condition with expected survival less than 6 months;

A do-not-resuscitate directive;

Cardiac decompensation in a patient who has already been declined for ventricular assist device or transplant;

Known neurologic devastation without potential to recover meaningful function;

Determination of care futility (see Policy Guidelines section).

The use of ECMO may be considered medically necessary as a bridge to heart, lung, or combined heart-lung transplantation for the management of adults with respiratory, cardiac, or combined cardiorespiratory failure refractory to optimal conventional therapy.

The use of ECMO is considered investigational when the above criteria are not met, including but not limited to acute and refractory cardiogenic shock and as an adjunct to cardiopulmonary resuscitation.

Treatment of primary focal hyperhidrosis using aluminum chloride 20% solution, botulinum toxin for severe primary axillary hyperhidrosis inadequately managed with topical agents, in individuals ≥18 y, OR Endoscopic Transthoracic Sympathectomy (ETS) and surgical excision of axillary sweat glands, if conservative treatment (ie, aluminum chloride or botulinum toxin, individually and in combination) has failed may be considered medically necessary with any of the following medical conditions:

acrocyanosis of the hands; or

history of recurrent skin maceration with bacterial or fungal infections; or

history of recurrent secondary infections; or

history of persistent eczematous dermatitis despite medical treatments with topical dermatologic or systemic anticholinergic agents.

Treatment of hyperhidrosis is considered investigational in the absence of functional impairment or any of the above medical conditions.

The following treatments may be considered medically necessary for the treatment of severe secondary gustatory hyperhidrosis:

aluminum chloride 20% solution

surgical options (ie, tympanic neurectomy) if conservative treatment has failed.

Other treatments are considered investigational as a treatment for severe secondary gustatory hyperhidrosis including, but not limited to:

botulinum toxin

iontophoresis.

Treatments that may be considered medically necessary by focal region include:

Axillary

Aluminum chloride 20% solution

Botulinum toxin for severe primary axillary hyperhidrosis inadequately managed with topical agents, in individuals ≥18 y

ETS and surgical excision of axillary sweat glands, if conservative treatment (ie, aluminum chloride or botulinum toxin, individually and in combination) has failed;

Palmar

Aluminum chloride 20% solution

Botulinum toxin type A products for severe primary palmar hyperhidrosis inadequately managed with topical agents, in individuals ≥18 y

ETS, if conservative treatment (ie, aluminum chloride or botulinum toxin type A, individually and in combination) has failed;

Plantar

Aluminum chloride 20% solution

Craniofacial

Aluminum chloride 20% solution

ETS, if conservative treatment (ie, aluminum chloride) has failed.

Treatments that are considered investigational by focal region include:

Axillary

Axillary liposuction

Iontophoresis

Microwave treatment

Radiofrequency ablation;

Palmer

RimabotulinumtoxinB

Iontophoresis

Microwave treatment

Radiofrequency ablation;

Plantar

Botulinum toxin

Iontophoresis

Lumbar sympathectomy

Microwave treatment

Radiofrequency ablation;

Craniofacial

Botulinum toxin

Iontophoresis

Microwave treatment

Radiofrequency ablation.

Electronic brachytherapy for the treatment of nonmelanoma skin cancer is considered investigational.

Use of intraoperative radiotherapy may be considered medically necessary in the following situation:

Rectal cancer with positive or close margins with T4 lesions or recurrent disease.

Use of intraoperative radiotherapy is considered investigational for all other oncologic applications.

Corrección de trastornos de la visión no proceden para pago irrespectivo de la técnica o modalidad utilizada. Esto incluye, pero no se limita, a espejuelos, lentes de contacto, cirugía refractiva, anillas intracorneales (Intacs) y lentes intraoculares multifocales.
Estos servicios se cubrirán solamente en aquellas pólizas que expresamente así lo indiquen.
La información relacionada a cobertura de Intacs y a keratoplastia fototeraoeutica se encuentra en las políticas 7.04.01 y 7.01.32 respectivamente.

All adoptive immunotherapy techniques intended to enhance autoimmune effects are considered investigational for the indications included, but not limited to, cancers associated with Epstein-Barr virus, Cytomegalovirus-associated cancers, nasopharyngeal cancer, renal cell carcinoma, gastric cancer, colorectal cancer, hepatocellular carcinoma, non-small-cell lung cancer, melanoma, glioblastoma multiforme, medullary thyroid cancer, pancreatic cancer, and cancers treated with autologous peripheral T lymphocytes containing tumor antigen-specific T cell receptors.

Sipuleucel-T therapy may be considered medically necessary in the treatment of asymptomatic or minimally symptomatic, androgen-independent (castration-resistant) metastatic prostate cancer.

Sipuleucel-T therapy is considered investigational in all other situations, including but not limited to, treatment of hormone-responsive prostate cancer, treatment of moderate-to-severe symptomatic metastatic prostate cancer, and treatment of visceral (liver, lung, or brain) metastases.

Catheter-based techniques for lysis of epidural adhesions, with or without endoscopic guidance, are considered investigational. Techniques used either alone or in combination include mechanical disruption with a catheter and/or injection of hypertonic solutions with corticosteroids, analgesics, or hyaluronidase.

Single-compartment or multichamber nonprogrammable lymphedema pumps applied to the limb may be considered medically necessary for the treatment of lymphedema that has failed to respond to conservative measures, such as elevation of the limb and use of compression garments.

Single-compartment or multichamber programmable lymphedema pumps applied to the limb may be considered medically necessary for the treatment of lymphedema when:

1.       The individual is otherwise eligible for nonprogrammable pumps; and

2.       There is documentation that the individual has unique characteristics (eg, significant scarring) that prevent satisfactory pneumatic compression with single-compartment or multichamber nonprogrammable lymphedema pumps.

Single-compartment or multichamber lymphedema pumps applied to the limb are considered investigational in all situations other than those specified above in the first 2 policy statements.

The use of lymphedema pumps to treat the trunk or chest in patients with lymphedema with or without involvement of the upper and/or lower limbs is considered investigational.

The use of lymphedema pumps applied to the head and neck to treat lymphedema is considered investigational.

The use of pneumatic compression pumps to treat venous ulcers is considered investigational.

Occupational therapy services are considered for payment when they are performed to address the need of a patient who is physically disabled due to disease, trauma, congenital anomalies or by condition due to a therapeutic intervention; these services must meet all the following criteria:

·         Those services that require the constant attention of a licensed occupational therapist (PT), a doctor of Medicine (MD), doctor of osteopathy (DO) or a chiropractor (DC).  This professional will arrive to a diagnosis and will identify those goals that can be reasonably met, will quantify the improvement within a reasonable time predictable.

·         Provide an effective reasonable treatment and specific for the diagnosis of the patient and his physical condition.

·         These services must be provided by a qualified provider and licensed by the relevant entities.

·         These services will be provided as long as measurable progress is demonstrated with possibility of rehabilitation or any other necessary medical objective.

Services that do not meet the above criteria will not be considered for payment.  Certain types of treatment that generally do not require the skills of a provider qualified in occupational therapy are not covered for payment.  These types of services include:

·         Repetitive exercises to improve walking or running or provide resistance to unstable patients.

·         Ranges of passive movements (RPOM) not related to the restoration of a loss of specific function.

·         Infrared heat, paraffin baths and baths under any circumstances.

·         Preventive activities and maintenance.

·         Behavior disorder treatment.

·         Treatment of mental retardation.

·         Treatment of delayed development.

·         Treatment when there is no quantifiable progress when it pursues a restorable goal.

·         Services beyond those needed to restore the ability to carry out activities of daily living.

·         Services in which therapeutic benefits or possibility of improvement are not expected.

·         Services in which their duration is predetermined by a specific time rather than the condition of the patient, the results of treatment or medical progress of the patient.

·         Services that seek to improve the physical condition of the patient or the repetitive exercises or exercises using equipment to improve the strength and endurance.

·         Therapies or services that are considered to be part of custodial services.

·         Not supervised services.

·         Hospital care is not considered for payment if the admission to the hospital was for the purpose of receiving occupational therapy.

Duplicate therapies are considered when the patient receives physical therapy and occupational therapy on the same day of service and the services are the same.  Two therapies must provide different treatments.

Each therapy must have its own goals and treatment plan.

·         If a patient visits a provider for physical therapy and another for occupational therapy they count as two visits.

·         If a patient visits a provider for physical therapy and occupational therapy they count as one visit.

Aquatic therapy to improve or restore physical function after illness, trauma or physical damage or loss of any part of the body is considered for payment if all the following conditions are met:

• The service is provided under the direct supervision of a licensed physical therapist and whose therapy has been ordered by a physician;

• The therapeutic interventions are given and continue according to a regime that includes the goals to be achieved ordered and signed by a doctor;

• The patient must show impairments, functional limitations or disabilities that can be minimized or eliminated with aquatic therapy;

• The patient should benefit from the unique properties of water (eg flotation, hydrodynamics and hydrostatic pressure);

• The patient must be unable to participate in a physical therapy program entirely outside of the aquatic environment due to weight-bearing restrictions, severe weakness or other considerations; Y

• The documentation must show the need for this type of intervention;

• The aquatic therapy offered requires the skills of a physical therapist;

• A qualified physical therapist will be physically present and in charge of the treatment;

• Aquatic therapy services will always be in accordance with the standards of medical practice and according to the patient’s condition.

The radium 223 injection (Xofigo) is considered for payment when all of the following criteria for prostate cancer are fulfilled:

1.     Insured is diagnosed metastatic prostate cancer resistant to castration.

2.     Insured has symptomatic bone metastases.

3.     Insured does not have any known visceral metastatic disease.

4.     Radium 223 is not used concomitantly with cytotoxic chemotherapeutic drugs (for example, docetaxel, cabazitaxel, mitoxantrone).

5.     The dosage does not exceed 1 injection every 28 days during 6 injections.

Note. The therapy of androgens deprivation (for example, leuprolide, degarelix, abiraterone), denosumab, or zoledronic acid are not considered cytotoxic chemotherapy. The concomitant use is permitted.

Duration of approval: 6 months

50 kbq (1.35 microcurie) per kg of body weight administered at intervals of 4 weeks of 6 injections.  Refer to the product label for factors table of decay correction.

Dry needling of trigger points for the treatment of myofascial pain is considered investigational.

One or more courses of photodynamic therapy may be considered medically necessary for the following oncologic applications:

palliative treatment of obstructing esophageal cancer

palliative treatment of obstructing endobronchial lesions

treatment of early-stage non-small-cell lung cancer in patients who are ineligible for surgery and radiotherapy

treatment of high-grade dysplasia in Barrett esophagus

palliative treatment of unresectable cholangiocarcinoma when used with stenting.

Other oncologic applications of photodynamic therapy are investigational including, but not limited to, other malignancies and Barrett esophagus without associated high-grade dysplasia.

Low-level laser therapy may be considered medically necessary for prevention of oral mucositis in patients undergoing cancer treatment associated with increased risk of oral mucositis, including chemotherapy and/or radiotherapy, and/or hematopoietic cell transplantation (see Policy Guidelines).

Low-level laser therapy is considered investigational for all other indications including but not limited to:

Carpal tunnel syndrome

Neck pain

Subacromial impingement

Adhesive capsulitis

Temporomandibular joint pain

Low back pain

Osteoarthritic knee pain

Heel pain (ie, Achilles tendinopathy, plantar fasciitis)

Rheumatoid arthritis

Bell palsy

Fibromyalgia

Wound healing

Lymphedema.

High-dose rate prostate brachytherapy may be considered medically necessary as monotherapy or in conjunction with external-beam radiotherapy in the treatment of localized prostate cancer.

High-dose rate prostate brachytherapy is considered investigational in the treatment of prostate cancer when used as salvage therapy.

Transurethral water vapor thermal therapy is considered investigational as a treatment of benign prostatic hyperplasia.

Transurethral waterjet ablation (aquablation) is considered investigational as a treatment of benign prostatic hyperplasia.

Charged-particle irradiation with proton or helium ion beams may be considered medically necessary for treatment in the following clinical situations:

primary therapy for melanoma of the uveal tract (iris, choroid, or ciliary body), with no evidence of metastasis or extrascleral extension, and with tumors up to 24 mm in largest diameter and 14 mm in height;

postoperative therapy (with or without conventional high-energy x-rays) in patients who have undergone biopsy or partial resection of chordoma or low-grade (I or II) chondrosarcoma of the basisphenoid region (skull-base chordoma or chondrosarcoma) or cervical spine. Patients eligible for this treatment have residual localized tumor without evidence of metastasis;

pediatric central nervous system tumors.

Charged-particle irradiation with proton or helium ion beams may be considered medically necessary where treatment planning with conventional or advanced photon-based radiotherapy cannot meet dose-volume constraints for normal tissue radiation tolerance (see Policy Guidelines section) in the following clinical situations:

in the curative treatment of primary or benign solid pediatric non-central nervous system tumors, including Ewing sarcoma;

in the curative treatment of nonmetastatic primary non-small cell lung cancer;

head and neck cancers.

Other applications of charged-particle irradiation with proton or helium ion beams may be considered investigational. This includes, but may not be limited to:

clinically localized prostate cancer;

non-curative treatment of primary or benign solid pediatric non-central nervous system tumors, including Ewing sarcoma;

non-curative treatment of non-small cell lung cancer.

The use of recombinant or natural interferon alfa for the treatment of hematologic malignancies (lymphomas, leukemias, or plasma-cell malignancies) is medically necessary in off-label use for:

· first-line treatment of patients with Philadelphia chromosome-positive CML in first chronic phase;

· as a component of first-line treatment of patients with multiple myeloma, or as maintenance therapy of patients with multiple myeloma that has responded to first-line therapy;

· a combination with cytotoxic agents as first-line therapy of aggressive low-grade (follicular) or intermediate-grade non-Hodgkin’s lymphoma.

Off-label applications of chelation therapy (see Policy Guidelines section for uses approved by the U.S. Food and Drug Administration) are considered investigational, including, but not limited to:

Alzheimer disease

atherosclerosis (eg, coronary artery disease, secondary prevention in individulas with myocardial infarction, or peripheral vascular disease)

autism

diabetes

multiple sclerosis

arthritis (includes rheumatoid arthritis).

Inhaled nitric oxide may be considered medically necessary as a component of treatment of:

Hypoxic respiratory failure in neonates born at more than 34 weeks of gestation.
Other indications for inhaled nitric oxide are investigational, including, but not limited to:
Treatment of premature neonates born at less than or equal to 34 weeks of gestation with hypoxic respiratory failure;

Treatment of adults and children with acute hypoxemic respiratory failure;

Postoperative use in adults and children with congenital heart disease;

In lung transplantation, during and/or after graft reperfusion.

Measurement of exhaled nitric oxide is considered investigational in the diagnosis and management of asthma, eosinophilic asthma, and other respiratory disorders including but not limited to chronic obstructive pulmonary disease and chronic cough.

Measurement of exhaled breath condensate is considered investigational in the diagnosis and management of asthma and other respiratory disorders including but not limited to chronic obstructive pulmonary disease and chronic cough.

Neutron beam radiotherapy of advanced salivary gland tumors and soft tissue sarcomas is considered medically necessary in cases meeting the criteria below:
 Salivary gland tumors in which disease-free surgical margins are not obtainable or where local recurrence has developed.
– Tumors classified as T3b or greater (i.e., tumors larger than 4 cm).
 Advanced or recurrent soft tissue sarcomas without nodal involvement or distant metastases.
– Primary treatment of T2 tumors (i.e., tumors larger than 5 cm).
– Treatment of tumor recurrence (i.e., T1 or T2 tumors).
 Advanced unresectable adenocarcinoma of the prostate, using neutrons in combination with photon radiotherapy (i.e., mixed-beam therapy)
– Tumor extends into or beyond the prostatic capsule (i.e., tumors classified C or T3);
– Tumor extends into neighboring tissues (i.e., tumors classified D or T4).

Scintimammography, breast-specific gamma imaging, and molecular breast imaging are considered investigational in all applications, including but not limited to their use as an adjunct to mammography or in staging the axillary lymph nodes.

Use of breast specific gamma detection following radiopharmaceutical administration for localization of sentinel lymph nodes in individuals with breast cancer may be considered medically necessary.

Intracavitary balloon catheter brain brachytherapy is considered investigational,alone or as part of a multimodality treatment regimen, for primary or recurrent malignant brain tumors.

Intracavitary balloon catheter brain brachytherapy is considered investigational, alone or as part of a multimodality treatment regimen, for metastasis to the brain from primary solid tumors outside the brain.

ERWINAZE is considered for payment in the treatment of acute lymphocytic leukemia and acute myeloid leukemia according to established protocols.

When using radiotherapy after breast-conserving surgery for early-stage breast cancer:

Accelerated whole-breast irradiation (AWBI) may be considered medically necessary for individuals who meet the following conditions:

Invasive carcinoma of the breast,

tumors ≤5 cm in diameter,

negative lymph nodes,

technically clear surgical margins, ie, no ink on tumor on invasive carcinoma or ductal carcinoma in situ, and

age at least 50 years old.

AWBI is considered investigational in all other situations involving treatment of early-stage breast cancer after breast-conserving surgery.

Interstitial or balloon brachytherapy may be considered medically necessary for individuals undergoing initial treatment for stage I or II breast cancer when used as local boost irradiation in those who are also treated with breast-conserving surgery and whole-breast external-beam radiotherapy.

Accelerated partial-breast irradiation (APBI), including interstitial APBI, balloon APBI, intraoperative APBI, external-beam APBI, and noninvasive brachytherapy using AccuBoost, is considered investigational.

Noninvasive brachytherapy using AccuBoost for individuals undergoing initial treatment for stage I or II breast cancer when used as local boost irradiation in those who are also treated with breast-conserving surgery and whole-breast external-beam radiotherapy is considered investigational.

Organ Rejection After Solid Organ Transplant

Extracorporeal photopheresis may be considered medically necessary to treat cardiac allograft rejection, including acute rejection, that is either recurrent or that is refractory to standard immunosuppressive drug treatment.

Extracorporeal photopheresis is considered investigational in all other situations related to treatment or prevention of rejection in solid organ transplantation.

Graft-Versus-Host Disease

Acute

Extracorporeal photopheresis may be considered medically necessary as a technique to treat acute graft-versus-host disease (GVHD) that is refractory to medical therapy.

Extracorporeal photopheresis is considered investigational as a technique to treat acute GVHD that is either previously untreated or is responding to established therapies.

Chronic

Extracorporeal photopheresis may be considered medically necessary as a technique to treat chronic GVHD that is refractory to medical therapy.

Extracorporeal photopheresis is considered investigational as a technique to treat chronic GVHD that is either previously untreated or is responding to established therapies.

Autoimmune Diseases

Extracorporeal photopheresis is considered investigational as a technique to treat either cutaneous or visceral manifestations of autoimmune diseases, including but not limited to scleroderma, systemic lupus erythematosus, rheumatoid arthritis, pemphigus, psoriasis, multiple sclerosis, diabetes, autoimmune bullous disorders, severe atopic dermatitis, or Crohn’s disease.

Cutaneous T-Cell Lymphoma

Extracorporeal photopheresis may be considered medically necessary as a technique to treat late-stage (III or IV) cutaneous T-cell lymphoma.

Extracorporeal photopheresis may be considered medically necessary as a technique to treat early-stage (I or II) cutaneous T-cell lymphoma that is progressive and refractory to established nonsystemic therapies.

Extracorporeal photopheresis is considered investigational as a technique to treat early-stage (I or II) cutaneous T-cell lymphoma that is either previously untreated or responsive to established nonsystemic therapies.

Other

Extracorporeal photopheresis is considered investigational for all other indications.

Lung transplantation may be considered medically necessary for carefully selected patients with irreversible, progressively disabling, end-stage pulmonary disease unresponsive to maximum medical therapy (see Policy Guidelines).

A lobar lung transplant from a living or deceased donor may be considered medically necessary for carefully selected patients with end-stage pulmonary disease (see Policy Guidelines).

Lung or lobar lung retransplantation after a failed lung or lobar lung transplant may be considered medically necessary in patients who meet criteria for lung transplantation.

Lung or lobar lung transplantation is considered investigational in all other situations.

Magnetic resonance imaging-targeted biopsy of the prostate may be considered medically necessary for diagnosis and active surveillance of prostate cancer.

Transplants, such as a multivisceral transplant and a small bowel and liver transplant, may be considered medically necessary for pediatric and adult individuals with intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance) who have been managed with long-term total parenteral nutrition and who have developed evidence of impending end-stage liver failure.

Retransplants, such as a multivisceral retransplant and a small bowel and liver retransplant, may be considered medically necessary after a failed primary small bowel and liver transplant or multivisceral transplant.

A small bowel and liver transplant or multivisceral transplant is considered investigational in all other situations.

Autologous pancreas islet transplantation may be considered medically necessary as an adjunct to a total or near-total pancreatectomy in individuals with chronic pancreatitis.

Allogeneic islet transplantation using an FDA-approved cellular therapy product (donislecel-jujn [ie, Lantidra]) is considered investigational for the treatment of type 1 diabetes.

Islet transplantation with donislecel-jujn is considered investigational in all other situations.

Treatment of nonhealing diabetic lower-extremity ulcers using the following human amniotic membrane products (Affinity®, AmnioBand® Membrane, Biovance®, EpiCord®, EpiFix®, Grafix™) may be considered medically necessary.

Human amniotic membrane grafts with or without suture (Prokera®, AmbioDisk™) may be considered medically necessary for the treatment of the following ophthalmic indications:

Neurotrophic keratitis with ocular surface damage and inflammation that does not respond to conservative therapy;

Corneal ulcers and melts that do not respond to initial conservative therapy;

Corneal perforation when there is active inflammation after corneal transplant requiring adjunctive treatment;

Bullous keratopathy as a palliative measure in patients who are not candidates for curative treatment (eg, endothelial or penetrating keratoplasty);

Partial limbal stem cell deficiency with extensive diseased tissue where selective removal alone is not sufficient;

Moderate or severe Stevens-Johnson syndrome;

Persistent epithelial defects that do not respond within 2 days to conservative therapy;

Severe dry eye (DEWS 3 or 4) with ocular surface damage and inflammation that remains symptomatic after Steps 1, 2, and 3 of the dry eye disease management algorithm (see Policy Guidelines); or

Moderate or severe acute ocular chemical burn.

Human amniotic membrane grafts with suture or glue may be considered medically necessary for the treatment of the following ophthalmic indications:

Corneal perforation when corneal tissue is not immediately available; or

Pterygium repair when there is insufficient healthy tissue to create a conjunctival autograft.

Human amniotic membrane grafts with or without suture are considered investigational for all ophthalmic indications not outlined above.

Injection of micronized or particulated human amniotic membrane is considered investigational for all indications, including but not limited to treatment of osteoarthritis and plantar fasciitis.

Injection of human amniotic fluid is considered investigational for all indications.

All other human amniotic products (eg, derived from amnion, chorion, amniotic fluid, umbilical cord, or Wharton’s jelly) not listed above are considered investigational (see policy guidelines).

All other indications not listed above are considered investigational, including but not limited to treatment of lower-extremity ulcers due to venous insufficiency and repair following Mohs micrographic surgery.

Composite tissue allotransplantation of the hand and/or face is considered investigational.

Kidney transplants with either a living or cadaver donor may be considered medically necessary for carefully selected candidates with end-stage renal disease.

Kidney retransplant after a failed primary kidney transplant may be considered medically necessary in patients who meet criteria for kidney transplantation.

Kidney transplant is considered investigational in all other situations.

Implantation of intrastromal corneal ring segments may be considered medically necessary for the treatment of keratoconus in patients 21 years of age or older who meet the following criteria:

The patient has experienced a progressive deterioration in vision, such that he or she can no longer achieve adequate functional vision with contact lenses or spectacles; AND
Corneal transplantation is the only alternative to improve their functional vision; AND
The patient has a clear central cornea with a corneal thickness of 450 microns or greater at the proposed incision site.

Implantation of intrastromal corneal ring segments is considered not medically necessary as a treatment of myopia.

Implantation of intrastromal corneal ring segments is considered investigational for all other conditions.

Intravitreal bevacizumab (Avastin)

Intravitreal bevacizumab (Avastin) injections is considered medically necessary for the treatment of the following indications:

Diabetic macular edema
Proliferative diabetic retinopathy
Macular edema following retinal vein occlusion (BRVO)
Neovascular (wet) AMD
Neovascular glaucoma
Polypoidal choroidal vasculopathy
Choroidal neovascularization, (including myopic choroidal neovascularization (mCNV), angioid streaks, choroiditis [including choroiditis secondary to ocular histoplasmosis], idiopathic degenerative myopia, retinal dystrophies, rubeosis iridis, pseudoxanthoma elasticum, and trauma)
Retinopathy of prematurity

Intravitreal bevacizumab (Avastin)  injections is considered investigational for any other ophthalmological indications not mentioned above.

Ranibizumab (Lucentis)/Ranibizumab-eqrn (Cimerli)

Intravitreal ranibizumab (Lucentis) or Ranibizumab-eqrn (Cimerli) is considered  medically necessary  for the treatment of the following indications:

Diabetic macular edema
Diabetic retinopathy
Macular edema following retinal vein occlusion (BRVO)
Myopic choroidal neovascularization
Neovascular (wet) AMD

Ranibizumab-eqrn (Cimerli)  is interchangeable with ranibizumab (Lucentis).

Intravitreal ranibizumab (Lucentis) or Ranibizumab-eqrn (Cimerli) is considered investigational for any other ophthalmological indications not mentioned above.

Ranibizumab (Susvimo)

Intravitreal ranibizumab (Susvismo) is considered  medically necessary  for the treatment of the following indications:

Neovascular (wet) AMD who have previously responded to at least two intravitreal injections of a VEGF inhibitor.

Intravitreal ranibizumab (Susvismo) is considered investigational for any other ophthalmological indications not mentioned above.

Intravitreal aflibercept (Eylea)

Intravitreal aflibercept (Eylea) is considered medically necessary for the treatment of the following indications:

Diabetic macular edema
Diabetic retinopathy
Macular edema following retinal vein occlusion (including central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO)
Neovascular (wet) AMD.
Retinopathy of prematurity (ROP) with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 2+ or 3+)
or AP-ROP (aggressive posterior ROP) disease.

Intravitreal aflibercept (Eylea) is considered investigational for any other ophthalmological indications not mentioned above.

Intravitreal brolucizumab-dbll (Beovu)

Brolucizumab-dbll intravitreal injection (Beovu) is considered medically necessary for the treatment of neovascular (wet) age-related macular degeneration.

Brolucizumab-dbll intravitreal injection (Beovu) is considered investigational for any other ophthalmological indications not mentioned above.

Pegaptanib sodium injection (Macugen)

Pegaptanib sodium injection (Macugen) is considered medically necessary for the treatment of individuals with neovascular (wet) age-related macular degeneration (AMD).

Pegaptanib sodium injection (Macugen) is considered investigational for any other ophthalmological indications not mentioned above.

Ranibizumab-nuna (Byooviz)

Intravitreal ranibizumab-nuna (Byooviz) is considered medically necessary for the treatment of the following indications:

Macular edema following retinal vein occlusion (RVO)
Neovascular (Wet) Age-Related Macular Degeneration (AMD).
Myopic Choroidal Neovascularization (mCNV)

Intravitreal ranibizumab-nuna (Byooviz) is considered investigational for any other ophthalmological indications not mentioned above.

Faricimab-svoa (Vabysmo)

Intravitreal Faricimab-svoa (Vabysmo) is considered medically necessary for the treatment of the following indications:

Diabetic macular edema (DME)
Neovascular (Wet) Age-Related Macular Degeneration (AMD).

Intravitreal Faricimab-svoa (Vabysmo) is considered investigational for any other ophthalmological indications not mentioned above.

Vertebral axial decompression is considered investigational.

Verteporfin photodynamic therapy as monotherapy may be considered medically necessary as a treatment of choroidal neovascularization associated with age-related macular degeneration, pathologic myopia, presumed ocular histoplasmosis, chronic central serous chorioretinopathy, or choroidal hemangioma.

Verteporfin photodynamic therapy is considered investigational as monotherapy for other ophthalmologic disorders.

Verteporfin photodynamic therapy is considered investigational when used in combination with one or more of the antivascular endothelial growth factor therapies: pegaptanib (Macugen®), ranibizumab (Lucentis®), bevacizumab (Avastin®), or aflibercept (Eylea™) as a treatment of choroidal neovascularization associated with age-related macular degeneration, pathologic myopia, presumed ocular histoplasmosis, central serous chorioretinopathy, choroidal hemangioma, or for other ophthalmologic disorders.

Speech Therapy services are considered for payment when:

• They are prescribed or recommended by a doctor for the purpose of restoring or improving function in a patient with a physical impairment in phonation, due to illness, trauma, congenital anomaly or as a result of a therapeutic intervention, AND

• The patient is expected to achieve measurable improvement in a predictable and reasonable period of time (usually four to six months), AND

• Provide effective, specific and reasonable treatment for patient’s diagnosis and physical condition, AND

• They are provided according to a treatment plan, where changes in patient’s condition are evaluated, documented, and are certified by a doctor at least every thirty (30) days where the following is included:

The date of onset or exacerbation of the disorder/diagnosis;
The speech therapy evaluation;
Specific statements of long-term and short-term goals that are specific, quantifiable (measurable) and objective;
A reasonable estimate of when the goals will be reached;
The specific treatment techniques and/or exercises to be used in treatment; and
The frequency and duration of treatment, which must be medically necessary and consistent with generally accepted standards of practice for speech therapy.

• The speech therapy services provided must be of the complexity and nature to require that they are performed by a licensed speech-language pathologist; and

• Services that cannot be reasonably taught and implemented by a family member, and

• Do not duplicate services covered by any other type therapy being received.

Speech therapy often occurs in the school environment or in developmental language centers. Speech therapy is not covered for payment for any of the following conditions:

• Speech dysfunction that in itself is corrected alone, such as errors in articulation in children who are not related to a specific medical condition.

• Maintenance therapies aimed at preserving the present level of function and avoiding regression of that function, including services to maintain function using methods or procedures using routines, repetition or reinforcement.

• Procedures that can be effectively performed by family members, teachers, guardians/guardians or the patient himself.

• Developmental disorders not related to a medical condition, including but not limiting itself to:

Psychosocial language delay
Behavioral Disorders
Attention Deficit
Conceptual Disorders mental retardation developmental delay
Stuttering, babbling
Reduced cognitive function

Occupational therapy services home based are considered for payment when performed to address the need for a patient suffering from physical damage due to disease, trauma, congenital anomalies or therapeutic intervention in those homebound insured.

Occupational Therapy services must meet the following criteria:

1.  Fill the functional needs of the patient.

2.  Achieve the goal of improvement in the expected time for the condition or diagnosis of the patient.
3.  Provide specific, reasonable, and effective treatment for the diagnosis and the patient’s physical condition.
4. Being offered by a certified professional.

The care plan occupational therapy session should include the following:

1.  State specific goal for the short and long range.
2.  Measurable objectives
3.  A reasonable estimate of when the goal can be achieved.
4.  Specific treatment techniques on activities to be used in the treatment.
5. The frequency and duration of treatment.

Occupational Therapy session (one hour) should include:

1. Basic activities of daily living and self-care.
2. Instructions for developing high level of independence.
3. Program functional exercises for functional limbs.
4. Evaluation and cognitive training, perception and safety.
5. Program for orthotics and prosthetics for upper extremities.
6. Train the patient and family in exercise programs at home.

Physical therapy in the home is considered for payment if it meets the following criteria:

a. Prior to hospitalization, the patient had total functional capacity for self-care, ambulation and movement.

b. It fills the functional needs of the patient who was discharged from the hospital, after suffering from an illness, surgery or injury, which limits the person in their functions or daily living activities.

Example: The patient’s walking mode does not offer safety. This must be documented in a way that evidences the need for a physical therapy program in the home.

c. To reach the goal of improvement in a predictable and reasonable period of time.

d. Provide a specific, reasonable and effective treatment for the diagnosis and condition of the patient.

• Example: The goal of physical therapy is to progress the patient from a state of confinement or dependence from one team to another or none, to ambulate safely, etc.

They are offered under the supervision of a participating doctor.

F. They require the judgment, knowledge and skills of qualified personnel.

It covers session (which can be one hour) and all the necessary modalities. A session should include:

The exercise program (coordination and restriction) to increase strength and

The education of the family on the exercise program to offer continuity.

The care plan should include:

The duration time with your long and short term goals.

Modalities and exercises that will be used in the treatment.

The frequency and duration of treatment.

These services must be authorized by the Individual Case Management Section.

It is not considered for payment:

1. Duplicate therapy (physical and occupational should provide different treatments).

2. Treatment that does not require a qualified provider with special skills such as:

a. Passive movement (range of motion) arc not related to the restoration of the loss of a specific function.

b. None of the following when given separately or to a patient who has no complications (paraffin baths, hot or cold packs, whirlpool heat by infrared rays, etc.).

3. Maintenance programs.

Transplantation of cord blood stem cells from related or unrelated donors may be considered medically necessary in patients with an appropriate indication for allogeneic stem cell transplant.

Transplantation of cord blood stem cells from related or unrelated donors is considered investigational in all other situations.

Collection and storage of cord blood from a neonate may be considered medically necessary when an allogeneic transplant is imminent in an identified recipient with a diagnosis that is consistent with the possible need for allogeneic transplant.

Prophylactic collection and storage of cord blood from a neonate may be considered not medically necessary when proposed for some unspecified future use as an autologous stem cell transplant in the original donor, or for some unspecified future use as an allogeneic stem cell transplant in a related or unrelated donor.

Suture button suspensionplasty for thumb carpometacarpal joint osteoarthritis is considered investigational.

Benign prostatic hyperplasia (BPH) is a common, noncancerous, and benign enlargement of the prostate gland. BPH is the main cause of significant lower urinary tract symptoms (LUTS) in older individuals with a prostate, including urinary frequency, urinary urgency, feelings of incomplete emptying, having to get up to urinate at night, difficulty starting a urinary stream, or a weak stream that starts and stops. There are multiple means of treatment for the condition, medication being the first line of treatment, and then surgery is considered when all other methods have failed. Symptoms recurrence, and/or complications determine if the patient is a candidate for surgery.

Holmium laser enucleation of the prostate (HoLEP) is an alternative to the gold standard surgery Transurethral Resection of the Prostate (TURP). It is a minimally invasive treatment that does not require an incision. HoLEP is used during a cystoscopy, which guides the laser to access the enlarged tissue of the prostate near the bladder. The laser is used to cut excess tissue out of the prostate gland. It can vaporize, cut through the prostate, and also help to cauterize / coagulate small to medium-sized blood vessels. A significant amount of prostate tissue can be resected with minimal amounts of bleeding. HoLEP has minimal side effects compared to the TURP procedure.

Photo vaporization of the prostate (PVP) is considered an alternative for the Transurethral Resection of the Prostate (TURP). It removes excess prostate tissue by means of vaporization and coagulates the remaining soft tissue using light. PVP has become the reference surgical technique to manage patients who cannot stop anticoagulation/antiplatelet therapy.

The following are Investigational for treating salivary stones due to insufficient evidence: Extracorporeal shock wave lithotripsy (ESWL) and endoscopic intracorporeal laser lithotripsy.

Triple-S Salud does not routinely recognize separate sedation payment for endoscopic procedures. These services are usually included in the fee as an integral part of the procedure performed by the doctor.
The intervention of the anesthesiologist for the performance of endoscopies is not always considered necessary, in agreement with the related professional organizations.
Joint Commission on Accreditation of Healthcare Organizations (JCAHO), uses the recommendations of the Practice Guidelines for Sedation and Analgesia by Non Anesthesiologists issued by American Society of Anesthesiologist. These guides have the endorsement of American Society for Gastrointestinal Endoscopy.

Joint Commission on Accreditation of Healthcare Organizations (JCAHO), adopts the guidelines establishing the standard for the credentialing of the personnel involved in the sedation and according to these, the hospital is not required the intervention of the anesthesiologist. However, some people have interpreted the standards of Revision 63: 04/01/2012 JCAHO as a mandatory intervention of the anesthesiologist in this endoscopy procedure.

If the hospital establishes this practice to require the anesthesiologist to perform its service in the endoscopy rooms when there is no exception to the medical policy, Triple-S Salud and/or the member will not be responsible for the payment of these services that don’t meet the criteria’s.

This rule does not apply to patients hospitalized or in the emergency room.

If the patient requires sedation and even general anesthesia for this being medically necessary, the service is covered with prior authorization to the gastroenterologist who will perform the endoscopy service as well as the surgeon who will perform the procedure. Medical necessity must be justified and documented in the patient record. It is necessary that the anesthesiologist in these cases add the pre-authorization number addressed to the gastroenterologist or the surgeon in the box corresponding to these purposes.

Sedation / analgesia would proceed for payment without requiring prior authorization in gastrointestinal endoscopies, bronchoscopies and pain control procedures when they meet the criteria specified and included below. Documentation of medical conditions is required when documenting significant risks that justify this exception. These exception conditions include any of the following:

1.     High Risk Patients

a. Pregnant
b. Epilepsy
c. Children 12 years of age or younger
d. Persons 65 years of age or older

2.        Danger of Obstruction in the respiratory track

a. History of sleep apnea

b. People with malformations in their facial structure such as people with Pierre-Robin syndrome or Down syndrome (Trisomy 21).
c. People with oral abnormalities such as small opening (less than 3cm in adults); protruding incisors, arch of the upper palate, macroglossia, tonsillar hypertrophy, or an invisible uvula.
d. People with abnormalities in the neck, such as obesity, short neck, limited neck extension, spinal cord instability, «hyoidmental» distance less than 3cm in adults, neck mass, disease or cervical cord trauma. People with anomalies of the facial structures, disorders of the cranial nerves IX or X, tracheal deviation, rheumatoid arthritis.
and.

e. Morbid obesity (BMI greater than 40 or BMI greater than 35 with co-morbid medical conditions (refractory hypertension, obstructive sleep apnea, coronary heart disease, type 2 diabetes).

3.          People with anticipated intolerance to common sedatives

a. People who have had previous problems with anesthesia or sedation.
b. Dependence of opiates, sedatives or hypnotics.
c. Drug or alcohol abuse.

4.          Other

a. People with dementia, psychiatric disorders, small children.
b. Complex procedures or invasive therapeutic procedures, for example: retrograde endoscopic cholangiopancreatography (ERCP), ultrasonic endoscopy (EUS), stenting of the upper gastrointestinal tract, emergency therapeutic procedures.
c. Patients hospitalized or in the Emergency Room.

The use of monitored anesthesia care may be considered medically necessary for gastrointestinal endoscopy, bronchoscopy, and interventional pain procedures when there is documentation by the proceduralist and anesthesiologist that specific risk factors or significant medical conditions are present. Those risk factors or significant medical conditions include any of the following:

Increased risk for complications due to severe comorbidity (American Society of Anesthesiologists class III, IV, or V [Table PG1])

Morbid obesity (body mass index >40 kg/m2)

Documented sleep apnea

Inability to follow simple commands (cognitive dysfunction, intoxication, or psychological impairment)

Spasticity or movement disorder complicating the procedure

History or anticipated intolerance to standard sedatives, such as

Chronic opioid use

Chronic benzodiazepine use

Individuals with active medical problems related to drug or alcohol abuse

Individuals younger than 18 years or 70 years or older

Individuals who are pregnant

Individuals with increased risk for airway obstruction due to anatomic variation, such as:

History of stridor

Dysmorphic facial features

Oral abnormalities (eg, macroglossia)

Neck abnormalities (eg, neck mass)

Jaw abnormalities (eg, micrognathia)

Acutely agitated, uncooperative individuals

Prolonged or therapeutic gastrointestinal endoscopy procedures requiring deep sedation (see Policy Guidelines section).

The use of monitored anesthesia care is considered investigational for gastrointestinal endoscopic, bronchoscopic, or interventional pain procedures in individuals at average risk related to use of anesthesia and sedation.

Trasplante de tejido mesencefálico embriónico.

Este método consiste en un trasplante intracerebral de tejido mesencefálico fetal. Los resultados de múltiples estudios están siendo analizados por CAPIT (Core Assessment Program for Intracerebral Transplantations). Al presente esta modalidad de tratamiento no se considera para pago. La evidencia es insuficiente para llegar a conclusiones sobre los resultados a largo plazo.

A small bowel transplant using cadaveric intestine may be considered medically necessary in adult and pediatric individuals with intestinal failure (characterized by loss of absorption and the inability to maintain protein-energy, fluid, electrolyte, or micronutrient balance), who have established long-term dependence on total parenteral nutrition (TPN) and are developing or have developed severe complications due to TPN.

A small bowel transplant using a living donor may be considered medically necessary only when a cadaveric intestine is not available for transplantation in an individual who meets the criteria noted above for a cadaveric intestinal transplant.

A small bowel retransplant may be considered medically necessary after a failed primary small bowel transplant.

A small bowel transplant using living donors is considered not medically necessary in all other situations.

A small bowel transplant is considered investigational for adult and pediatric individuals with intestinal failure who can tolerate TPN.

Trasplante alogenéico nomieloablativo de células madres se considera para pago en aquellos pacientes que cumplen con los criterios de selección para tratamiento con quimioterapia en dosis altas y trasplante de células madres. Las siguientes condiciones están cubiertas:
Linfoma Non-Hodgkin (BCBS 8.01.20)

Enfermedades Mielodisplasicas (BCBS 8.01.21)

Leucemia Mielógena Aguda (BCBS 8.01.26)

Enfermedad de Hodgkin (BCBS 8.01.29)

Leucemia Mielógena Crónica (BCBS 8.01.30)

Leucemia Linfocítica Aguda (BCBS 8.01.32)

Myeloma multiple (BCBS 8.01.17)

Otras aplicaciones de trasplantes nomioablativo alogenéico de células madres no se consideran para pago. En estas aplicaciones se incluyen pero no se limitan a pacientes que no cumplen criterios para quimioterapia en dosis altas y trasplante alogenéico de células madres debido a edad o comorbilidades.
No se considera para pago el tratamiento de otras malignidades incluyendo mieloma múltiple, carcinoma de célula renal o cualquier otro tumor sólido.

Pancreas transplant after a prior kidney transplant may be considered medically necessary in patients with insulin-dependent diabetes.

A combined pancreas and kidney transplant may be considered medically necessary in insulin-dependent diabetic patients with uremia.

Pancreas transplant alone may be considered medically necessary in patients with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin-dependent diabetes that persists despite optimal medical management.

Pancreas retransplant after a failed primary pancreas transplant may be considered medically necessary in patients who meet criteria for pancreas transplantation.

Pancreas transplant is considered investigational in all other situations.

A liver transplant using a cadaver or living donor may be considered medically necessary for carefully selected individuals with end-stage liver failure due to irreversibly damaged livers. Etiologies of end-stage liver disease include, but are not limited to, the following.

A. Hepatocellular diseases

Alcoholic liver disease

Viral hepatitis (either A, B, C, or non-A, non-B)

Autoimmune hepatitis

α1-Antitrypsin deficiency

Hemochromatosis

Nonalcoholic steatohepatitis

Protoporphyria

Wilson disease.

B. Cholestatic liver diseases

Primary biliary cirrhosis

Primary sclerosing cholangitis with development of secondary biliary cirrhosis

Biliary atresia.

C. Vascular disease

Budd-Chiari syndrome.

D. Primary hepatocellular carcinoma (see Policy Guidelines section for individual selection criteria).

E. Inborn errors of metabolism.

F. Trauma and toxic reactions.

G. Miscellaneous

Familial amyloid polyneuropathy.

Liver transplantation may be considered medically necessary in individuals with polycystic disease of the liver who have massive hepatomegaly causing obstruction or functional impairment.

Liver transplantation may be considered medically necessary in individuals with unresectable hilar cholangiocarcinoma (see Policy Guidelines section for individual selection criteria).

Liver transplantation may be considered medically necessary in pediatric individuals with nonmetastatic hepatoblastoma.

Liver retransplantation may be considered medically necessary in individuals with:

primary graft nonfunction

hepatic artery thrombosis

chronic rejection

ischemic type biliary lesions after donation after cardiac death

recurrent non-neoplastic disease-causing late graft failure.

Combined liver-kidney transplantation may be considered medically necessary in individuals who qualify for liver transplantation and have advanced irreversible kidney disease.

Liver transplantation is investigational in the following situations:

Individuals with intrahepatic cholangiocarcinoma

Individuals with neuroendocrine tumors metastatic to the liver.

Liver transplantation is considered not medically necessary in the following individuals:

Individuals with hepatocellular carcinoma that has extended beyond the liver (see Policy Guidelines section for individual selection criteria)

Individuals with ongoing alcohol and/or drug abuse. (Evidence for abstinence may vary among liver transplant programs, but generally a minimum of 3 months is required).

Liver transplantation is considered investigational in all other situations not described above.

Human heart transplantation may be considered medically necessary for select adults and children with end-stage heart failure when the following individual selection criteria are met.

Adult Individuals

Accepted Indications for Cardiac Transplantation

Hemodynamic compromise due to heart failure demonstrated by any of the following 3 bulleted items,

Maximal oxygen consumption (Vo2) <10 mL/kg/min with achievement of anaerobic metabolism; Refractory cardiogenic shock; Documented dependence on intravenous inotropic support to maintain adequate organ perfusion; or Severe ischemia consistently limiting routine activity not amenable to bypass surgery or angioplasty; or Recurrent symptomatic ventricular arrhythmias refractory to all accepted therapeutic modalities. Probable Indications for Cardiac Transplantation Maximal Vo2 <14 mL/kg/min and major limitation of the individual's activities; or Recurrent unstable ischemia not amenable to bypass surgery or angioplasty; or Instability of fluid balance/renal function not due to individual noncompliance with a regimen of weight monitoring, flexible use of diuretic drugs, and salt restriction. The following conditions are inadequate indications for cardiac transplantation unless other factors as listed above are present. Ejection fraction <20%; History of functional class III or IV symptoms of heart failure; Previous ventricular arrhythmias; Maximal Vo2 >15 mL/kg/min.

Pediatric Individuals

Individuals with heart failure and persistent symptoms at rest who require 1 or more of the following:

Continuous infusion of intravenous inotropic agents; or

Mechanical ventilatory support; or

Mechanical circulatory support.

Individuals with heart disease and symptoms of heart failure who do not meet the above criteria but who have:

Severe limitation of exercise and activity (if measurable, such individuals would have a maximum Vo2 <50% predicted for age and sex); or Cardiomyopathies or previously repaired or palliated congenital heart disease and significant growth failure attributable to the heart disease; or Near sudden death and/or life-threatening arrhythmias untreatable with medications or an implantable defibrillator; or Restrictive cardiomyopathy with reactive pulmonary hypertension; or Reactive pulmonary hypertension and risk of developing fixed, irreversible elevation of pulmonary vascular resistance that could preclude orthotopic heart transplantation in the future; or Anatomic and physiologic conditions likely to worsen the natural history of congenital heart disease in infants with a functional single ventricle; or Anatomic and physiologic conditions that may lead to consideration for heart transplantation without systemic ventricular dysfunction. Heart retransplantation after a failed primary heart transplant may be considered medically necessary in individuals who meet the criteria for heart transplantation. Heart transplantation is considered investigational in all other situations.

The use of functional endoscopic sinus surgery is considered medically necessary for individuals with chronic rhinosinusitis when the following criteria are present:

Chronic rhinosinusitis that negatively impacts quality of life, characterized by at least 2 of the following, at least 1 of which is (a) or (b), present for at least 12 continuous weeks:

Mucopurulent nasal drainage (anterior, posterior, or both);

Nasal obstruction (congestion);

Facial pain-pressure-fullness;

Decreased sense of smell.
AND

Optimal medical therapy has been attempted and failed, as indicated by all of the following:

Allergy evaluation, education, and optimal treatment when indicated;

Two 10 day courses of antibiotics or 1 prolonged course of oral antibiotic for at least 21 days;

Decongestants when indicated;

Topical and/or systemic corticosteroids for at least 8 weeks;

Saline nasal irrigations for at least 8 consecutive weeks;

Treatment of rhinitis medicamentosa (rebound nasal congestion due to extended use of topical decongestants), when present;

Education on environmental irritants including tobacco smoke.
AND

Clinical and radiographic documentation of persistent inflammation following optimal medical therapy (see Policy Guidelines).

AND

There are no serious urgent complications of acute sinusitis that would suggest orbital cellulitis or abscess, intracranial extension of infection, or other complication that would require urgent or emergent surgery such that “appropriate medical therapy” for 8 weeks would not be appropriate.

The use of functional endoscopic sinus surgery is considered investigational for the treatment of chronic rhinosinusitis when the above criteria are not met.

Autologous chondrocyte implantation may be considered medically necessary for the treatment of disabling full-thickness articular cartilage defects of the knee caused by acute or repetitive trauma when all of the following criteria are met:

Adolescent patients should be skeletally mature with documented closure of growth plates (eg, ≥15 years). Adult patients should be too young to be considered an appropriate candidate for total knee arthroplasty or other reconstructive knee surgery (eg, <55 years) Focal, full-thickness (grade III or IV) unipolar lesions of the weight-bearing surface of the femoral condyles, trochlea, or patella at least 1.5 cm2 in size Documented minimal to absent degenerative changes in the surrounding articular cartilage (Outerbridge grade II or less), and normal-appearing hyaline cartilage surrounding the border of the defect Normal knee biomechanics or alignment and stability achieved concurrently with autologous chondrocyte implantation. Autologous chondrocyte implantation for all other joints, including the talar, and any indications other than those listed above is considered investigational.

The maze or modified maze procedure, performed on a non-beating heart during cardiopulmonary bypass with concomitant cardiac surgery, is considered medically necessary for treatment of symptomatic atrial fibrillation or flutter.

Stand-alone minimally invasive, off-pump maze procedures (ie, modified maze procedures), including those done via mini-thoracotomy, are considered investigational for treatment of atrial fibrillation or flutter.

Hybrid ablation (defined as a combined percutaneous and thoracoscopic approach) is considered investigational for the treatment of atrial fibrillation or flutter.

The use of an open maze or modified maze procedure performed on a non-beating heart during cardiopulmonary bypass without concomitant cardiac surgery is considered not medically necessary for treatment of atrial fibrillation or flutter.

Three-dimensional (3D) printed orthopedic implants that have a design that is approved or cleared by the Food and Drug Administration (FDA) and produced in standard sizes for patients with typical bone and joint anatomy are investigational.

Patient-matched 3D printed implants that are based on non-standard shapes and sizes for patients with typical bone and joint anatomy and do not qualify as custom devices according to FDA custom device exemption requirements are investigational.

Custom 3D printed implants for patients with bone or joint deformity may be considered medically necessary when the devices are produced at a central manufacturing facility and meet FDA custom device exemption requirements.

Three-dimensional printed orthopedic implants produced outside of FDA-regulated manufacturing facilities are investigational.

Radiofrequency ablation of the renal sympathetic nerves is considered investigational for the treatment of uncontrolled hypertension.

Balloon kyphoplasty may be considered medically necessary for the treatment of symptomatic thoracolumbar osteoporotic vertebral compression fractures that have failed to respond to conservative treatment (eg, analgesics, physical therapy, rest) for at least 6 weeks.

Mechanical vertebral augmentation with an FDA-cleared device may be considered medically necessary for the treatment of symptomatic thoracolumbar osteoporotic vertebral compression fractures that have failed to respond to conservative treatment (eg, analgesics, physical therapy, rest) for at least 6 weeks.

Balloon kyphoplasty may be considered medically necessary for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Mechanical vertebral augmentation with an FDA-cleared device may be considered medically necessary for the treatment of severe pain due to osteolytic lesions of the spine related to multiple myeloma or metastatic malignancies.

Balloon kyphoplasty or mechanical vertebral augmentation with an FDA-cleared device is considered investigational for all other indications, including use in acute vertebral fractures due to osteoporosis or trauma.

Radiofrequency kyphoplasty is considered investigational.

Mechanical vertebral augmentation using any other device is considered investigational.

Use of patient-specific instrumentation (eg, cutting guides) for joint arthroplasty, including but not limited to use in unicompartmental or total knee arthroplasty, is investigational.

Injection of allograft into the intervertebral disc for the treatment of degenerative disc disease is considered investigational.

Cryoablation for chronic rhinitis (allergic or nonallergic) is considered investigational.

Radiofrequency ablation for chronic rhinitis (allergic or nonallergic) is considered investigational.

Laser ablation for chronic rhinitis (allergic and non allergic) is considered investigational.

The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention in individuals with atrial fibrillation undergoing open or thoracoscopic cardiac procedures is considered investigational.

The use of surgical left atrial appendage occlusion devices, including the AtriClip device, for stroke prevention as a stand-alone procedure for stroke prevention in individuals with atrial fibrillation is considered investigational.

Uterus transplantation for absolute uterine factor infertility is considered investigational.

Liposuction for lipedema or lymphedema is considered investigational.

Surgical deactivation of trigger sites is considered investigational for the treatment of migraine and nonmigraine headache.

Handheld radiofrequency spectroscopy for intraoperative assessment of surgical margins during breast-conserving surgery is considered investigational.

Surgical treatment of groin pain in athletes (also known as athletic pubalgia, Gilmore groin, osteitis pubis, pubic inguinal pain syndrome, inguinal disruption, slap shot gut, sportsmen groin, footballers groin injury complex, hockey groin syndrome, athletic hernia, sports hernia, or core muscle injury) is considered investigational.

Balloon dilation of the eustachian tube (BDET) for treatment of chronic obstructive eustachian tube dysfunction (ETD) may be considered medically necessary under the following conditions:

Adults (age 22 years and older) with symptoms of obstructive eustachian tube dysfunction (aural fullness, aural pressure, otalgia, and/or hearing loss) for 12 months or longer in one or both ears that significantly affects quality of life or functional health status

Aural fullness and pressure must be present (see Policy Guidelines)

AND

The patient has undergone a comprehensive diagnostic assessment; including patient-reported questionnaires, history and physical exam, tympanometry if the tympanic membrane is intact, nasal endoscopy, and comprehensive audiometry, with the following findings:

Abnormal tympanogram (Type B or C)

Abnormal tympanic membrane (retracted membrane, effusion, perforation, or any other abnormality identified on exam)

AND

Failure to respond to appropriate medical management of potential co-occurring conditions, if any, such as allergic rhinitis, rhinosinusitis, and laryngopharyngeal reflux, including 4-6 weeks of a nasal steroid spray, if indicated

AND

Other causes of aural fullness such as temporomandibular joint disorders, extrinsic obstruction of the eustachian tube, superior semicircular canal dehiscence, and endolymphatic hydrops have been ruled out.

AND

If the individual had a history of tympanostomy tube placement, symptoms of obstructive ETD should have improved while tubes were patent.

AND

The individual does not have patulous ETD or another contraindication to the procedure (see Policy Guidelines).

AND

The individual’s ETD has been shown to be reversible (see Policy Guidelines).

AND

Symptoms are continuous rather than episodic (e.g., symptoms occur only in response to barochallenge such as pressure changes while flying).

AND

The individual has not had a previous BDET procedure.

Balloon dilation of the eustachian tube is considered investigational if the above criteria are not met.

Synthetic cartilage implants are considered investigational for the treatment of articular cartilage damage.

Rhinoplasty

Rhinoplasty may be considered for payment only in the following limited situations:

•    When it is being performed to correct a nasal deformity secondary to congenital cleft lip and or palate:

o    Upon individual case review, to correct chronic non-septal nasal airway obstruction from vestibular stenosis (collapsed internal valves) due to trauma, disease, or congenital defect, when all of the following criteria are met:

•    Obstruction of nasal breathing in a persistent and prolonged way; and
•    Physical examination confirming vestibule obstruction from moderate – severe; and
•    Airways obstruction will not respond to Septoplasty and tubinectomy only; and
•    Blockage of the nasal passages were causing significant symptoms (e.g., chronic rhinosinusitis, breathing difficulty); and
•    Persistent symptoms of obstruction before a conservative management for 3 months or more, including, when appropriate, the use of steroids or immunotherapy; and
•    Photos showing an external nasal deformity; and
•    Obstruction on average is 50% or more (e.g., 50% obstruction in both nostrils, or 75% blockage in one nostril and 25% obstruction in the other, or 100% blockage in one nostril), documented by nasal endoscopy, computerized tomography or other imaging modality appropriate for this purpose.
•    When the rhinoplasty for nasal obstruction is carried out as an integral part of a medically necessary Septoplasty, and there is documentation regarding nasal obstruction on the same side of the septal deviation.

Triple-S Salud considers rhinoplasty cosmetic and not covered for payment for any other indication not included in this policy.

Triple-S Salud does not consider for payment the suspension of nasal valve for the repair of nasal valve collapse.

The use of steroid-eluting sinus stents and implants for postoperative treatment following endoscopic sinus surgery and for treatment of recurrent sinonasal polyposis is considered investigational.

The use of steroid-eluting sinus stents and implants is considered investigational in all other conditions.

Magnetic resonance imaging-targeted biopsy of the prostate may be considered medically necessary for diagnosis and active surveillance of prostate cancer.

Use of prostatic urethral lift in individuals with moderate-to-severe lower urinary tract obstruction due to benign prostatic hyperplasia may be considered medically necessary when all of the following criteria are met:

The individual has persistent or progressive lower urinary tract symptoms despite medical therapy (α1-adrenergic antagonists maximally titrated, 5α-reductase inhibitors, or combination medication therapy maximally titrated) over a trial period of no less than 6 months, or is unable to tolerate medical therapy; AND,

Prostate gland volume is ≤80 mL; AND,

Prostate anatomy demonstrates normal bladder neck without an obstructive or protruding median lobe; AND,

Individual does not have urinary retention related to conditions other than benign prostatic hyperplasia, urinary tract infection, or recent prostatitis (within past year); AND,

Individual has had appropriate testing to exclude diagnosis of prostate cancer; AND,

Individual does not have a known allergy to nickel, titanium or stainless steel.

Use of prostatic urethral lift in other situations, including repeat procedures, is considered investigational

Endovascular therapy, including percutaneous transluminal angioplasty with or without stenting, is considered investigational for the management of extracranial vertebral artery diseases.

Lumbar discectomy

Traditional approach (open)

Automated percutaneous discectomy

Automated endoscopic discectomy

(see Policy Guidelines section) may be considered medically necessary for the treatment of lumbar herniated disc when the following criteria are met:

Signs and symptoms of radiculopathy on history and physical exam (see Policy Guidelines section).

One of the following clinical presentations is present:

Rapidly progressing neurologic deficits; OR

Persistent debilitating back or leg pain that is refractory to at least 6 weeks of conservative therapy (see Policy Guidelines section).

Documentation of nerve root compression on imaging (magnetic resonance imaging or computed tomography) at a level that corresponds with the patient’s symptoms (see Policy Guidelines section).

Lumbar discectomy is not medically necessary for the treatment of lumbar herniated disc when the above criteria are not met.

Cervical discectomy

Traditional approach (open)

Automated percutaneous discectomy

Automated endoscopic discectomy

(see Policy Guidelines section) may be considered medically necessary for the treatment of cervical herniated disc when the following criteria are present:

Signs and symptoms of radiculopathy and/or myelopathy on history and physical exam (see Policy Guidelines section).

One of the following clinical presentations is present:

Rapidly progressing neurologic deficits; OR

Persistent debilitating neck, back, or arm pain that is refractory to at least 6 weeks of conservative therapy (see Policy Guidelines section); OR

Persistent or progressive symptoms of myelopathy that are refractory to at least 6 weeks of conservative therapy (see Policy Guidelines section).

Documentation of nerve root compression on imaging (magnetic resonance imaging or computed tomography) at a level that corresponds with the patient’s symptoms (see Policy Guidelines section).

Cervical discectomy is not medically necessary for the treatment of cervical herniated disc when the above criteria are not met.

Discectomy is considered investigational for all other indications.

Responsive neurostimulation may be considered medically necessary for individuals with focal epilepsy who meet ALL of the following criteria:

· Are 18 years or older;

· Have a diagnosis of focal seizures with 1 or 2 well-localized seizure foci identified;

· Have an average of 3 or more disabling seizures (eg, motor focal seizures, complex focal seizures, or secondary generalized seizures) per month over the prior 3 months;

· Are refractory to medical therapy (have failed ≥2 appropriate antiepileptic medications at therapeutic doses);

· Are not candidates for focal resective epilepsy surgery (eg, have an epileptic focus near the eloquent cerebral cortex; have bilateral temporal epilepsy); and

· Do not have contraindications for responsive neurostimulation device placement (see Policy Guidelines section).

Responsive neurostimulation is considered investigational for all other indications.

Peripheral subcutaneous field stimulation is investigational.

Use of the vertical expandable prosthetic titanium rib is considered medically necessary in the treatment of progressive thoracic insufficiency syndrome due to rib and/or chest wall defects in infants and children between 6 months of age and skeletal maturity.

Use of the vertical expandable prosthetic titanium rib for all other conditions, including but not limited to the treatment of scoliosis in patients without thoracic insufficiency, is considered investigational.

Triple-S considers for routine foot care services when:

· The provider has the proper qualifications.

· The service is considered effective and reasonable according to the condition of the patient described here.

· There is the presence of a systemic condition, whether of a kind:

Metabolic
Neurological
Periferal Vascular
These medical conditions result in circulatory dysfunction or areas of decreased sensation that place the patient at risk by taking care of the foot by a person without professional clinical training.
A Diabetic Neuropathy is evidenced with loss of protective sensation.
The diagnosis must have been established by a physical doctor prior to foot care by the Podiatrist.
In the case of podiatrists, the medical record must have the clinical certification by the physical physician of the pre-existing systemic condition.

Triple-S defines the service of routine foot care as medically necessary in those cases where there are systemic conditions with neurological, peripheral ischemic vascular involvement where:

The patient’s physical physician reports that there is a fungal infection of the nails and that it is of such a nature that it limits the patient’s ambulation, that he has pain or that he has a secondary infection due to the thickening and dystrophy of the finger caused by the nail. In the case of the podiatrist, this documentation must mediate in the medical file. The medical conditions associated with routine foot care are those whose risk ratio may be related to infections, portal of entry or deficiency in vascular healing.

The establishment of the diagnosis of fungal infection or onychomycosis can be established clinically by the Podiatrist or by the physical doctor without the need of clinical pathology services. The KOH test is an integral part of the payment for services in the evaluation and management visit

In cases of policyholders with severe vascular dysfunction, the following documentation is required per class of clinical finding:

Class A:

· Non-traumatic amputation of a foot or a skeletal integral portion

Class B:

·       Absent posterior tibial pulse

·       Absent pedal dorsalis pulse, or

Three of the following:

·       Decrease or absence of healthy growth

·       Discoloration or changes in skin pigmentation

·       Flushing or redness of the skin

·       Changes in skin texture

Class C

· Claudication

· Changes in foot temperature

· Edema

· Paresthesia

· Burning

There will be presumption of coverage in those cases where clinical findings are documented as detailed below. In addition, the modifier should be used as applicable:

On Class A finding èModifier Q7

Two Class B findings èModifier Q8

One Class B finding and two Class C findings èModifier Q9

For cases with peripheral neuropathy without vascular deficiency, the absence of sensation in two (2) or more places of the foot with the monofilament test of Semmes-Weinstein 5.07 should be documented in the medical file, considering that it does not apply to areas of hyperkeratosis or callus, in addition, of any deformity due to trauma, or overload.

Triple S does not consider routine foot care for payment when:

• There is no systemic condition as detailed in the previous section.

• Cut or removal of calluses.

• Treatment of fungal infected nails.

• Nail cutting.

• Foot cleaning and bathing.

• Application of creams.

• Any hygiene modality