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Danyelza

Danyelza may be considered medically necessary in patients 1 year of age or older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow and if the conditions indicated in this guideline are met.


Blenrep

Blenrep may be considered medically necessary in patients 18 years of age or older for the treatment of relapsed or refractory multiple myeloma and if the conditions indicated below are met.


Viscosupplementation Therapy For Knee

Viscosupplementation therapy is part of the therapy used in the treatment of osteoarthritis of the knee. Osteoarthritis results from articular cartilage failure due to the complex interplay of genetic, metabolic, biochemical and biomechanical factors with a secondary component of inflammation. In most patients the initiating mechanism is damage to the articular cartilage either as a single large injury or a series of repeated smaller injuries. The primary symptom of osteoarthritis of the knee is pain, however, because cartilage is aneural, significant radiographic findings are often noted in asymptomatic individuals imaged for other reasons.


Germline Genetic Testing for Hereditary Diffuse Gastric Cancer (CDH1, CTNNA1)

Germline genetic testing for CDH1 variants to identify individuals with or at risk for hereditary diffuse gastric cancer (HDGC) may be considered medically necessary for individuals meeting the following criteria (see Policy Guidelines):A diagnosis of diffuse gastric cancer (DGC) before age 50 years; OR

A diagnosis of DGC at any age in individuals of Maori ethnicity, or with a personal or family history of cleft/lip palate; OR

A diagnosis of bilateral lobular breast cancer before age 70 years; OR

Personal or family history of both DGC and lobular breast cancer, one diagnosed before age 70 years; OR

Two 1st- or 2nd-degree relatives (see Policy Guidelines) with a diagnosis of gastric cancer at any age, one DGC; OR

Two 1st- or 2nd-degree relatives (see Policy Guidelines) with a diagnosis of lobular breast cancer before 50 years of age.

Germline genetic testing for CDH1 variants in individuals not meeting the above criteria is considered investigational.

Germline genetic testing for CTNNA1 variants to identify individuals with or at risk for HDGC is considered investigational (see Policy Guidelines).


Molecular Testing for Germline Variants Associated with Ovarian Cancer (BRIP1, RAD51C, RAD51D, NBN)

Testing for germline BRIP1, RAD51C, and RAD51D variants for ovarian cancer risk assessment in adults may be considered medically necessary when the following criteria are met:The individual has a diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; AND

The individual has not previously been tested for these gene variants; AND

The individual is thought to be the most informative member of a family (proband) to have genetic testing (see Policy Guidelines); AND

The individual has closely related (first- and/or second-degree) relatives who are considering genetic testing for these gene variants to inform prophylactic decision-making or who have test results that cannot be fully interpreted without testing an affected relative; OR

The individual has not been diagnosed with epithelial ovarian cancer; AND

The individual has any blood relative with a known pathogenic/likely pathogenic germline BRIP1, RAD51C, or RAD51D variant; OR

The individual has a first- or second-degree relative diagnosed with ovarian cancer.a

Testing for germline NBN variants for ovarian cancer risk assessment in adults is considered investigational.

Testing for germline BRIP1, RAD51C, RAD51D, and NBN variants in individuals diagnosed with epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer to guide treatment of the diagnosed individual is considered investigational.

Testing for germline BRIP1, RAD51C, and RAD51D variants for ovarian cancer risk in adults who do not meet the criteria above is considered investigational.

a For familial assessment, first- and second-degree relatives are blood relatives on the same side of the family (maternal or paternal):

First-degree relatives: parents, siblings, and children

Second-degree relatives: grandparents, aunts, uncles, nieces, nephews, grandchildren, and half-siblings.


Serologic Genetic and Molecular Screening for Colorectal Cancer

It is well established that early detection of colorectal cancer (CRC) reduces disease-related mortality. For patients at average risk for CRC, organizations such as the U.S. Preventive Services Task Force have recommended several options for colon cancer screening. Currently accepted screening options for CRC include colonoscopy or sigmoidoscopy, fecal occult blood testing, and fecal immunochemical testing. However, many individuals do not undergo recommended screening with fecal tests or colonoscopy. A simpler screening blood test for genetic alterations associated with non-familial CRC may have the potential to encourage screening and decrease mortality if associated with increased screening compliance. Genetic testing is also being investigated to guide therapy.


Miscellaneous Genetic and Molecular Diagnostic Tests

All tests listed in this policy are considered investigational and grouped according to the categories of genetic testing outlined in evidence review 2.04.91:Testing of an affected (symptomatic) individual’s germline to benefit the individual (excluding reproductive testing)
Diagnostic testing
Prognostic testing
Therapeutic testing
Testing an asymptomatic individual to determine future risk of disease.


Genotype-Guided Tamoxifen Treatment

Genotyping to determine cytochrome P450 2D6 (CYP2D6) variants is considered investigational for the purpose of managing treatment with tamoxifen for women at high risk for or with breast cancer.


Circulating Tumor DNA and Circulating Tumor Cells for Cancer Management (Liquid Biopsy)

The use of circulating tumor DNA and/or circulating tumor cells is considered investigational for all indications reviewed herein  (see Policy Guidelines).


Invasive Prenatal (Fetal) Diagnostic Testing

Invasive prenatal (fetal) diagnostic testing may be used to identify pathogenic genetic alterations in fetuses at increased risk based on prenatal screening or on women who choose to undergo diagnostic testing due to other risk factors. This evidence review only addresses the use of chromosomal microarray (CMA) testing, molecular diagnosis of single-gene disorders, and next-generation sequencing.


Noninvasive Prenatal Screening for Fetal Aneuploidies, Microdeletions, Single-Gene Disorders and Twin Zygosity Using Cell-Free Fetal DNA

National guidelines recommend that all pregnant individuals be offered screening for fetal chromosomal abnormalities, most of which are aneuploidies, an abnormal number of chromosomes. Trisomy syndromes are aneuploidies involving 3 copies of 1 chromosome. Trisomies 21, 18, and 13 are the most common forms of fetal aneuploidy that survive to birth. There are numerous limitations to standard screening for these disorders using the maternal serum and fetal ultrasound. Noninvasive prenatal screening analyzing cell-free fetal DNA in maternal serum is a potential complement or alternative to conventional serum screening. Noninvasive prenatal screening (NIPS) using cell-free fetal DNA has also been proposed to screen for microdeletions. Prenatal testing for twin zygosity using cell-free fetal DNA has been proposed to inform decisions about early surveillance for twin-twin transfusion syndrome and other monochorionic twin-related abnormalities.


Multibiomarker Disease Activity Blood Test for Rheumatoid Arthritis

The use of a multibiomarker disease activity score for rheumatoid arthritis (eg, Vectra® score) is considered investigational in all situations.


Preimplantation Genetic Testing

Preimplantation genetic diagnosis may be considered medically necessary as an adjunct to in vitro fertilization (IVF) in couples not known to be infertile who meet one of the criteria listed below.For evaluation of an embryo at an identified elevated risk of a genetic disorder such as when:

Both partners are known carriers of a single-gene autosomal recessive disorder
One partner is a known carrier of a single-gene autosomal recessive disorder, and the partners have an offspring who has been diagnosed with that recessive disorder
One partner is a known carrier of a single-gene autosomal dominant disorder
One partner is a known carrier of a single X-linked disorder, or

For evaluation of an embryo at an identified elevated risk of structural chromosomal abnormality such as for a:

Parent with balanced or unbalanced chromosomal translocation.

Preimplantation genetic diagnosis as an adjunct to IVF is considered investigational in patients or couples who are undergoing IVF in all situations other than those specified above.

Preimplantation genetic screening as an adjunct to IVF is considered investigational in patients or couples who are undergoing IVF in all situations.


Genetic Testing for a Thalassemia

Genetic testing to confirm a diagnosis of α-thalassemia is considered not medically necessary.Genetic testing of patients with hemoglobin H disease (α-thalassemia intermedia) to determine prognosis is considered investigational.

Preconception (carrier) testing for α-thalassemia in prospective parents may be considered medically necessary when both parents have evidence of possible α-thalassemia (including α-thalassemia minor, hemoglobin H disease [α-thalassemia intermedia], or α-thalassemia minima [silent carrier] ) based on biochemical testing (see Policy Guidelines section).

Genetic testing for α-thalassemia in other clinical situations (recognizing that prenatal testing is not addressed in this policy) is considered investigational.


 Molecular Markers in Fine Needle Aspirates of the Thyroid

To determine which patients need thyroid resection, many physicians will perform a cytologic examination of fine needle aspirate (FNA) samples from a thyroid lesion; however, this method has diagnostic limitations. As a result, assays using molecular markers have been developed to improve the accuracy of thyroid FNA biopsies.


Genetic Testing for Diagnosis and Management of Mental Health Conditions

Genetic testing for diagnosis and management of mental health disorders is considered investigational in all situations, including but not limited to the following:To confirm a diagnosis of a mental health disorder in an individual with symptoms.

To predict future risk of a mental health disorder in an asymptomatic individual.

To inform the selection or dose of medications used to treat mental health disorders, including but not limited to the following medications:

selective serotonin reuptake inhibitors

selective norepinephrine reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors

tricyclic antidepressants

antipsychotic drugs.

Genetic testing panels for mental health disorders, including but not limited to the Genecept Assay, STA2R test, the GeneSight Psychotropic panel, the Proove Opioid Risk assay, and the Mental Health DNA Insight panel, are considered investigational for all indications.


Germline Genetic Testing for Hereditary Breast/Ovarian Cancer Syndrome and Other High-Risk Cancers (BRCA1, BRCA2, PALB2)

Genetic testing should be performed in a setting that has suitably trained health care providers who can give appropriate pre- and posttest counseling and that has access to a Clinical Laboratory Improvement Amendments-licensed laboratory that offers comprehensive variant analysis (see Policy Guidelines section: Comprehensive Variant Analysis).Individuals With Cancer or With a Personal History of Cancer

Genetic testing for BRCA1 and BRCA2 variants in cancer-affected individuals may be considered medically necessary under any of the following circumstances:

Individuals with any blood relative with a known pathogenic/likely pathogenic variant in a cancer susceptibility gene

Individuals meeting the criteria below but with previous limited testing (eg, single gene and/or absent deletion duplication analysis)

Personal history of breast cancer and 1 or more of the following:

Diagnosed at age ≤45 years; or

Diagnosed 46 to 50 years with:

An additional breast cancer primary at any age; or

≥1 close relative (see Policy Guidelines) with breast, ovarian, pancreatic, or prostate cancer at any age; or

An unknown or limited family history

Diagnosed ≤60 yearswith:

Triple-negative breast cancer (see Policy Guidelines)

Diagnosed at any age with:

≥1 close blood relative with:

Breast cancer diagnosed ≤50 years; or

Ovarian carcinoma; or

Metastatic or intraductal/cribriform prostate cancer, or high-risk group or very-high-risk group (see Policy Guidelines) prostate cancer; or

Pancreatic cancer; or

≥ 3 total diagnoses of breast cancer in individual and/or close blood relatives ; or

Ashkenazi Jewish ancestry

Diagnosed at any age with male breast cancer

Personal history of epithelial ovarian carcinoma (including fallopian tube cancer or peritoneal cancer) at any age

Personal history of exocrine pancreatic cancer at any age

Personal history of metastatic or intraductal/cribriform histology prostate cancer at any age; or high-risk group or very-high-risk group prostate cancer at any age

Personal history of prostate cancer at any age with:

≥1 close blood relative with ovarian carcinoma, pancreatic cancer, or metastatic or intraductal/cribriform prostate cancer at any age, or breast cancer ≤50 years; or

≥2 close blood relatives with breast or prostate cancer (any grade) at any age; or

Ashkenazi Jewish ancestry

Personal history of cancer and a mutation identified on tumor genomic testing that has clinical implications if also identified in the germline

Personal history of cancer and to aid in systemic therapy decision-making for PARP-inhibitors for ovarian cancer or prostate cancer, and platinum therapy for prostate cancer (see Policy Guidelines).

Genetic testing for PALB2 variants in cancer-affected individuals may be considered medically necessary in adults who meet the above criteria (exclusive of systemic therapy criteria) (see Policy Guidelines).

Individuals Without Cancer or With Other Personal History of Cancer

(See Policy Guidelines section: Testing Unaffected Individuals.)

Genetic testing for BRCA1,BRCA2, and PALB2 variants of cancer-unaffected individuals and individuals with cancer but not meeting the above criteria (including individuals with cancers unrelated to hereditary breast ovarian cancer syndrome) may be considered medically necessary under any of the following circumstances:

An individual with cancer not meeting the above criteria but who has a 1st- or 2nd-degree blood relative meeting any criterion listed above for Patients With Cancer (except individuals who meet criteria only for systemic therapy decision-making). If the individual with cancer has pancreatic cancer or prostate cancer (metastatic or intraductal/cribriform or high-risk group or very-high-risk group) then only first-degree relatives should be offered testing unless there are other family history indications for testing.

An individual with any type of cancer (cancer related to hereditary breast ovarian cancer syndrome but not meeting above criteria, or cancer unrelated to hereditary breast ovarian cancer syndrome) or unaffected individual who otherwise does not meet the criteria above but has a probability >5% of a BRCA1/2 or PALB2 pathogenic variant based on prior probability models (eg, Tyrer-Cuzick, BRCAPro, Pennll).

Genetic testing for BRCA1 and BRCA2 variants in cancer-affected individuals or of cancer-unaffected individuals with a family history of cancer when criteria above are not met is considered investigational.

Testing for PALB2 variants in individuals who do not meet the criteria outlined above is considered investigational.

Genetic testing in minors for BRCA1,BRCA2, and PALB2 variants for hereditary breast ovarian cancer syndrome is considered investigational(see Policy Guidelines).


Germline Genetic Testing for Gene Variants Associated With Breast Cancer in Individuals at High Breast Cancer Risk (CHEK2, ATM, and BARD1)

It is estimated that 3% to 5% of women presenting for assessment for hereditary breast/ovarian cancer risk have a variant in a gene that moderately increases the risk of cancer. CHEK2, ATM, and BARD1 variants are considered to be of moderate penetrance. Female carriers of CHEK2, ATM and BARD1 have an approximately 2- to 4-fold increased risk of developing breast cancer compared with the general population. Risk estimates may be higher in patients with a family history of breast cancer or a family history of a specific variant.Germline genetic testing for BRCA1, BRCA2, and PALB2 is addressed separately in evidence review 2.04.02.


Genetic Testing for Li-Fraumeni Syndrome

Li-Fraumeni syndrome (LFS) is a cancer predisposition syndrome associated with the development of several types of tumors. The syndrome is caused by germline pathogenic variants in the TP53 gene. Testing for LFS pathogenic variants may be useful in confirming the diagnosis of LFS and/or evaluating genetic status in asymptomatic relatives of an index case.


Chromosomal Microarray Testing for the Evaluation of Pregnancy Loss

Chromosomal microarray (CMA) testing of fetal tissue or placental tissue derived from the fetal genotype has been proposed as a technique to evaluate the cause of isolated and recurrent early pregnancy loss (miscarriages) and later pregnancy loss (intrauterine fetal demise [IUFD]). The evaluation of both recurrent and isolated miscarriages and IUFD may involve genetic testing of the products of conception. Such testing has typically been carried out through cell culture and karyotyping of cells in metaphase. However, the analysis of fetal or placental tissue has been inhibited by the following limitations: the need for fresh tissue, the potential for cell culture failure, and the potential for maternal cell contamination.


Gene Expression Profile Testing and Circulating Tumor DNA Testing for Predicting Recurrence in Colon Cancer

Gene expression profile (GEP) and circulating tumor DNA (ctDNA) tests have been developed for use as prognostic markers of stage II or III colon cancer to help identify patients who are at high-risk for recurrent disease and could be candidates for adjuvant chemotherapy.


Noninvasive Fetal RHD Genotyping Using Cell-Free Fetal DNA

Noninvasive fetal RHD genotyping using cell-free fetal DNA is considered investigational.


 Somatic Genetic Testing to Select Individuals with Melanoma or Glioma for Targeted Therapy or Immunotherapy

Testing for BRAF V600 variants in tumor tissue of patients with unresectable or metastatic melanoma may be considered medically necessary to select patients for treatment with Food and Drug Administration-approved BRAF inhibitors, MEK inhibitors, or immunotherapy.Testing for BRAF V600 variants in tumor tissue of patients with resected stage III melanoma may be considered medically necessary to select patients for treatment with Food and Drug Administration-approved BRAF or MEK inhibitors.

Testing for BRAF V600 variants for all other patients with melanoma is considered investigational.

Testing for BRAF V600 variants in patients with glioma to select patients for targeted treatment is considered investigational.

Testing for tumor mutational burden (TMB) in patients with unresectable or metastatic melanoma or glioma to select patients for treatment with Food and Drug Administration-approved immunotherapy is considered investigational.


Molecular Testing for the Management of Pancreatic Cysts, Barrett Esophagus, and Solid Pancreaticobiliary Lesions

Molecular testing using the PathFinderTG system is considered investigational for all indications including the evaluation of pancreatic cyst fluid, Barrett esophagus, and solid pancreaticobiliary lesions.


JAK2 and MPL Testing for Myeloproliferative Neoplasms

JAK2 testing may be considered medically necessary in the diagnosis of patients presenting with clinical, laboratory, or pathologic findings suggesting polycythemia vera, essential thrombocythemia (ET), or primary myelofibrosis (PMF). Based on criteria from the World Health Organization, documentation of a serum erythropoietin level below the reference range for normal is recommended before JAK2 testing (See Policy Guidelines).MPL and CALR testing may be considered medically necessary in the diagnosis of patients presenting with clinical, laboratory, or pathologic findings suggesting ET or PMF.

JAK2, MPL, and CALR testing is considered investigational in all other circumstances including, but not limited to, the following situations:

Diagnosis of nonclassic forms of myeloproliferative neoplasms

Molecular phenotyping of patients with myeloproliferative neoplasms

Monitoring, management, or selecting treatment in patients with myeloproliferative neoplasms.


Autologous blood transfusion (Cell Saver)

The self-transfusion «cell savers» is considered for payment in the following surgeries:A. General Surgery

.
1. Liver Resections
2. Bridges for splenectomy
3. Vascular surgery
4. Aneurysm
5. Liver Transplant
6. Kidney Transplant
7. Aortobifemoral graft

B. Orthopedics

1. Open reduction and fixation of pelvic fractures
2. Hip Replacement
3. Knee Replacement
4. Scoliosis (correction)

C. Thoracic surgery

1. Aortic aneurysm
2. Cardiac Transplant
3. Replacement or repair of heart valves
4. Aortocoronary bypass

D. Obstetrics and Gynecology

1. Ectopic pregnancy
2. Premature separation of placenta
3. Placenta accreta

E. Trauma

1. Aneurysm (cranial and aortic)
2. Lacerations of larger vessels
3. Liver fracture
4. Kidney Fracture


Endobronchial Brachytherapy

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.


Dry Hydrotherapy for Chronic Pain Conditions

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


Intraoperative Radiotherapy 

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.


Electronic Brachytherapy for Nonmelanoma Skin Cancer

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


Treatment of Hyperhidrosis

Treatment of primary focal hyperhidrosis using aluminum chloride 20% solution, botulinum toxin for severe primary axillary hyperhidrosis inadequately managed with topical agents, in patients ≥18 y, OR 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

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;

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.


Cellular Immunotherapy for Prostate Cancer

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.


Intracavitary Balloon Catheter Brain Brachytherapy for Malignant Gliomas or Metastasis to the Brain

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.


Accelerated Breast Irradiation and Brachytherapy Boost After Breast-Conserving Surgery for Early-Stage Breast Cancer

When using radiotherapy after breast-conserving surgery for early-stage breast cancer:Accelerated whole-breast irradiation (AWBI) may be considered medically necessary for patients 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 patients 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 patients 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.


High-Dose Rate Temporary Prostate Brachytherapy

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.


Low-Level Laser Therapy

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.


Oncologic Applications of Photodynamic Therapy, Including Barrett Esophagus

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.


Vascular Endothelial Growth Factor Inhibitors for the Treatment of Ophthalmological Diseases

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)

Intravitreal ranibizumab (Lucentis) 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

Intravitreal ranibizumab (Lucentis) 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.

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.


Hepatitis C Positive Organs for Transplantation to Non-Viremic Patients

The transplantation of hepatitis C virus (HCV) viremic solid organs (kidney, lung, heart, liver, small bowel, pancreas) to a HCV non-viremic recipient combined with direct-acting antiviral treatment for HCV is considered investigational.


Kidney Transplant

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.


Composite Tissue Allotransplantation of the Hand and Face

Composite tissue allotransplantation (also referred to as vascularized composite allotransplantation) is defined as transplantation of histologically different tissues. This type of transplantation is being proposed for facial transplants in patients with severely disfigured faces, and for hand transplants in patients dissatisfied with prosthetic hands. The treatment has potential benefits in terms of improving functional status and psychosocial well-being. It also has potential risks, most notably those associated with a lifelong regimen of immunosuppressive drugs.For individuals who have a severely disfigured face due to burns or trauma who receive composite tissue allotransplantation, the evidence includes a small case series and several systematic reviews of case series. Relevant outcomes are functional outcomes, quality of life, resource utilization, and treatment-related mortality and morbidity. The available studies on composite tissue allotransplantation of the face have suggested that the surgery is technically feasible; however, to date, only a limited number of patients worldwide have undergone the procedure, and the data are not sufficiently robust to determine whether the potential benefits to patients outweigh the potential risks (eg, of surgical complications, immunosuppression, opportunistic infections). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have hand and upper-extremity amputation(s) who receive composite tissue allotransplantation, the evidence includes a small case series, several systematic reviews of case series, and a nonrandomized comparative study. Relevant outcomes are functional outcomes, quality of life, resource utilization, and treatment-related mortality and morbidity. The available studies on composite tissue allotransplantation of the hand have suggested that the surgery is technically feasible. The only study comparing outcomes in patients who had hand transplants with those who received prostheses included 12 patients. It found no differences between groups in functional outcomes and little difference in the quality of life. Given the limited number of patients worldwide who have undergone the procedure and the limited amount of data comparing outcomes with the best available prosthetics, the evidence is not sufficiently robust to determine whether the potential benefits to patients outweigh the potential risks (eg, of surgical complications, immunosuppression, opportunistic infections). The evidence is insufficient to determine the effects of the technology on health outcomes.

Objective

The objective of this evidence review is to determine whether composite tissue allotransplantation of the hand and/or face improves the net health outcome compared with standard management without transplantation.

Policy

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

Policy Guidelines

Currently, there are no specific CPT codes for this procedure; however, should the procedure receive a code, it is likely that a combination of existing codes or the unlisted code for the anatomic area would be used (eg, 26989 unlisted procedure, hands or fingers).

Coding

Please see the Codes table for details

Benefit Application

Composite tissue allotransplantation is offered at specialized centers.

Background

Composite Tissue Allotransplantation

Composite tissue allotransplantation refers to the transplantation of histologically different tissue that may include skin, connective tissue, blood vessels, muscle, bone, and nerve tissue. The procedure is also known as reconstructive transplantation. To date, primary applications of this type of transplantation have been of the hand and face (partial and full), although there are also reported cases of several other composite tissue allotransplantations, including that of the larynx, knee, and abdominal wall.

Hand and face transplants have been shown to be technically feasible. The first successful partial face transplant was performed in France in 2005, and the first complete facial transplant was performed in Spain in 2010. In the U. S., the first facial transplant was done in 2008; it was a near-total face transplant and included the midface, nose, and bone. The first hand transplant with short-term success occurred in 1998 in France. However, the patient failed to follow the immunosuppressive regimen, which led to graft failure and removal of the hand 29 months after transplantation. The first hand transplantation in the U. S. took place in 1999.

Composite tissue allotransplantation procedures are complex and involve a series of operations using a rotating team of specialists. For face transplantation, the surgery may last 8 to 15 hours. Hand transplant surgery typically lasts between 8 and 12 hours. Bone fixation occurs first, and this is generally followed by the artery and venous repair and then by suture of nerves and/or tendons. In all surgeries performed to date, the median and ulnar nerves were repaired. The radial nerve was reconstructed in about half of the procedures.

Unlike most solid organ transplantations (eg, kidney and heart transplants), composite tissue allotransplantation is not life-saving, and its primary aim rests mainly in a patient’s cosmetic satisfaction and quality of life. In the case of facial transplantations, there is immense potential for the psychosocial benefits when surgery is successful. Moreover, the goal of composite tissue transplantation is to improve function (eg, grasping and lifting after hand transplants, blinking and mouth closure after face transplants) without alternative interventions such as prosthetics. Additionally, in the case of face transplantation, the procedure may be less traumatic than «traditional» facial reconstructive surgery using the patient’s own tissue. For example, traditional procedures often involve dozens of operations, whereas facial transplantation only involves a few operations.

Adverse Events

Composite tissue allotransplantation is associated with potential risks and benefits, and patients who undergo face or hand transplantation must adhere to a lifelong regimen of immunosuppressive drugs. Risks of immunosuppression include acute and chronic rejection, an opportunistic infection that may be life-threatening, and metabolic disorders such as diabetes, kidney damage, and lymphoma. Other challenges include the need to participate actively in intensive physical therapy to restore functionality and the potential for frustration and disappointment if functional improvement does not meet expectations. Moreover, there is the potential for allograft loss, which would lead to additional procedures in hand transplant patients, and there are limited reconstructive options for facial transplantation. Furthermore, in the case of hand transplants, there is a risk that functional ability (eg, grasping and lifting objects) may be lower than with a prosthetic hand, especially compared with newer electronic prosthetic devices. Due to the importance of selecting candidates who can withstand these physical and mental challenges, potential hand and face transplant recipients undergo extensive screening for both medical and psychosocial suitability.

Regulatory Status

Hand and face allotransplantations are surgical procedures and, as such, are not subject to regulation by the U.S. Food and Drug Administration.

Rationale

This evidence review was created in February 2013 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through May 16, 2022.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Population Reference No. 1 Policy Statement

Face Allotransplantation

Clinical Context and Therapy Purpose

The purpose of composite tissue allotransplantation in patients who have a severely disfigured face due to burns or trauma is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does composite tissue allotransplantation improve the net health outcome in those with a severely disfigured face due to burns or trauma?

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals who have a severely disfigured face due to burns or trauma.

Interventions

The therapy being considered is composite tissue allotransplantation.

The most commonly performed face transplant procedure has been to restore the lower two-thirds of facial structure, especially the perioral area (ie, lips, cheeks, chin) and in some cases the forehead, eyelids, and scalp.1, Facial transplantation has been performed on patients whose faces have been disfigured by trauma, burns, disease, or birth defects and who are unable to benefit from traditional surgical reconstruction.

Comparators

The following practice is currently being used to make decisions about grafting a face after burns or trauma: standard care without facial allotransplantation. Comparator is performed by a physician in a hospital or outpatient setting.

Outcomes

The general outcomes of interest are functional improvement, graft failure, quality of life (eg, psychosocial well-being), and treatment-related adverse events (eg, surgical complications, immunosuppression, infections).

Due to the complex nature of this lengthy surgical procedure, immediate postsurgical follow-up is needed, and lifelong follow-up will be necessary due to the immunosuppressive drugs required to prevent graft failure.

Review of Evidence

Systematic Reviews

As of December 2015, 37 face allotransplantation operations had been conducted, 20 partial faces and 17 full faces.2, A systematic analysis of outcomes was published by Smeets et al (2014).3, Reviewers included English-language articles, published through September 2013, that provided data on at least 1 face transplant in humans. Thirty-six articles reported on 27 worldwide face transplantations. Of the 27 cases, 10 were full-face transplants (the first successful full face transplant was in 2010) and the remainder were partial face transplants. The literature does not report any case of graft loss, hyperacute (within the first 48 hours) or chronic rejection, or graft-versus-host disease. However, all transplant recipients who were at least 1 year postsurgical follow-up reported experiencing at least 1 episode of acute rejection after the procedure. Other common complications were related to drug toxicity from immunosuppressive therapy, leading to opportunistic infections, metabolic disorders, and increased incidence of malignancy. There have been 3 reported cases of malignancy to date. Three deaths occurred in transplant recipients. One patient died 27 months after surgery due to lack of compliance with immunosuppressive therapy. A second death occurred in a French recipient who had a multidrug-resistant infection and graft necrosis (an early transplant). The third patient died of recurrent cancer.

In terms of function, tactile sensitivity recovered at a mean of 4.1 months postsurgery when nerve repair was performed or at a mean of 7.3 months otherwise. Temperature sensitivity recovered at a mean of 4.3 months with nerve repair and at 12.5 months without nerve repair. Motor recovery began at a mean of 7.8 months after surgery. Trialists indicated that recovery of motor function started with contractions of single muscles, and complex movements appeared within the first year in a number of patients. Long-term results are still pending in most cases. After 5 years of follow-up, the first face transplant recipient was able to fully open her mouth, smile, speak, chew, and swallow.

Case Series

Also, Fischer et al (2015) identified 29 face transplants performed through December 2013 and reported functional outcomes in 5 patients treated at their center.4, The investigators compared each patient’s pre- and postsurgical functioning on various dimensions. Before surgery, all 5 patients had compromised respiration, breathing, sensation, and facial expression. After surgery, patients had substantial recovery in all of these areas. In terms of breathing, all were able to breathe through their noses postsurgery, and 2 with tracheostomy tubes had them removed. Speech became understandable to an unfamiliar listener 3 to 9 months after surgery and at that time most allografts were responsive to light touch, and patients could distinguish between heat and cold. Facial expressions, including the ability to smile, recovered after transplantation in all patients. Three of 5 patients were unable to chew solid food before surgery, and 2 patients had liquid leakage. All patients were capable of oral food intake 3 to 29 days after surgery, and 3 to 12 months after surgery, all had unrestricted or nearly unrestricted eating and drinking. The 2 patients with compromised ability to smell both reported a substantial improvement in smelling, comparable with their functioning before the facial trauma. All 5 patients developed opportunistic infections (viral or bacterial) after facial transplantation.

Section Summary: Face Allotransplantation

The available studies on composite tissue allotransplantation of the face have suggested that the surgery is technically feasible. To date, however, given the limited number of patients worldwide who have undergone the procedure, the evidence is not sufficiently robust to determine whether the potential benefits to patients outweigh the potential risks (eg, of surgical complications, immunosuppression, opportunistic infections).

For individuals who have a severely disfigured face due to burns or trauma who receive composite tissue allotransplantation, the evidence includes a small case series and several systematic reviews of case series. Relevant outcomes are functional outcomes, quality of life, resource utilization, and treatment-related mortality and morbidity. The available studies on composite tissue allotransplantation of the face have suggested that the surgery is technically feasible; however, to date, only a limited number of patients worldwide have undergone the procedure, and the data are not sufficiently robust to determine whether the potential benefits to patients outweigh the potential risks (eg, of surgical complications, immunosuppression, opportunistic infections). The evidence is insufficient to determine the effects of the technology on health outcomes.

Population Reference No. 1 Policy Statement
[ ] MedicallyNecessary
[x ] Investigational
[ ] Not Medically Necessary

Population Reference No. 2 Policy Statement

Hand and Upper-Extremity Allotransplantation

Clinical Context and Therapy Purpose

The purpose of composite tissue allotransplantation in patients who have had ahand or upper-extremity amputation is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does composite tissue allotransplantation improve the net health outcome in those who have lost a hand or arm due to amputation?

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals who have had a hand or upper-extremity amputation.

Interventions

The therapy being considered is composite tissue allotransplantation.

Hand transplantations have been done in patients who lost a hand due to trauma or life-saving interventions that caused permanent injury to the hand. To date, hand transplants have not been performed for congenital anomalies or loss of a limb due to cancer.

Comparators

The following practice is currently being used to make decisions about grafting a hand or arm after amputation: standard care without hand and upper-extremity allotransplantation. Comparator is performed by a physician in a hospital or outpatient setting.

Outcomes

The general outcomes of interest are functional improvement, graft failure, quality of life (eg, psychosocial well-being), and treatment-related adverse events (eg, surgical complications, immunosuppression, infections).

Due to the complex nature of this lengthy surgical procedure, immediate postsurgical follow-up is needed, and lifelong follow-up will be necessary due to the immunosuppressive drugs required to prevent graft failure.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded.

Review of Evidence

Case Series

The most comprehensive reporting of the worldwide experience with hand and upper-limb transplants was published by Shores et al (2015).5, They identified 72 patients who received a total of 107 transplanted hand/upper extremities (35 received bilateral transplants, 37 unilateral). There are 4 known mortalities: 1 occurred after a bilateral hand transplant; the others followed multitype composite tissue allotransplantations (ie, combined upper- and lower-limb or combined upper-limb and face transplants). Twenty-four graft losses have been reported; 8 of them were also associated with multiple composite tissue allotransplantation procedures and another 7 occurred in China during early efforts with hand transplantation. In the U. S., 21 known patients have undergone isolated upper-limb transplantation; 13 were unilateral and 8 were bilateral (limb or digit) procedures. There was 1 immediate graft loss of the bilateral transplanted limb/digit. An additional 3 patients experienced hand loss at 9 months, 2 years, and 4 years posttransplant, respectively. Few data on functional outcomes after hand transplantation have been reported. The authors noted that there is a lack of agreement on appropriate outcome measures, and the level of transplantation varies greatly among patients, making it difficult to compare functional improvement.

An article describing data from the International Registry on Hand and Composite Tissue Allotransplantation was published by Pertuzzo and Dubernard (2011).6, At the time data were extracted, hand transplants had been reported to the registry for 39 patients. The authors stated that 85% of transplant recipients experienced at least 1 episode of acute rejection in the first year after transplant. Acute rejection episodes were reversible in all patients compliant with treatment. The most commonly reported complications were metabolic complications (35/39 [90%]) and opportunistic infections (30/39 [77%]). Transient hyperglycemia occurred in 17 (44%) patients and cytomegalovirus reactivation in 10 (26%) patients. Ten patients required surgery for complications (2 arterial thromboses, 1 venous thrombosis, 6 small area of skin necrosis, 1 venous fistula). Five cases of graft loss were reported between day 5 and day 275 after transplant. The early (day 5) graft loss occurred in a patient who underwent a face and bilateral hand transplant, and this patient died at day 65 from cerebral anoxia. This was the only reported death in this series of patients. Specific hand function data (eg, mean function scores) were not reported.

One study identified had compared health outcomes in patients undergoing hand transplantation with those receiving hand/upper-limb prostheses. This study, by Salminger et al (2016), compared outcomes for 5 patients who had below-elbow hand transplantation with 7 patients who had prosthetic hands.7, There were 3 unilateral and 2 bilateral hand transplants, for a total of 7 transplanted hands. The prosthetic patients received myoelectric prostheses controlled by simple direct control. Functional assessments were undertaken a mean of 9 years (standard deviation, 3.9 years) after transplantation. The following standardized instruments were used to evaluate function: the Action Research Arm Test, the Southampton Hand Assessment Procedure, and the Disabilities of the Arm, Shoulder and Hand measures. In addition, quality of life was assessed using the 36-Item Short-Form Health Survey (SF-36). There were no statistically significant differences between groups in functional scores on the standardized measures. For example, the mean Southampton Hand Assessment Procedure score was 75.0 in the transplanted group and 75.4 in the prosthetic group. For the quality of life scores, transplant patients had significantly higher scores on the SF-36 role-emotional and mental health subscales and there were no significant differences in the SF-36 physical functioning, bodily pain, general health, or social functioning subscales. The authors did not report total SF-36 scores.

Section Summary: Hand and Upper-Extremity Allotransplantation

A total of 107 hand and upper-extremity transplants had been conducted worldwide as of 2015 and data are reported in a number of case series. The available studies on composite tissue allotransplantation of the hand have suggested that the surgery is technically feasible. A single study (n=12) has compared outcomes for patients who had hand transplants with those receiving prostheses. It found no statistically significant differences in functional outcomes between groups and no differences in 4 of 7, SF-36 subscales. Given the limited number of patients worldwide who have undergone the procedure and the limited amount of data comparing outcomes with the best available prosthetics, the evidence is not sufficiently robust to determine whether the potential benefits to patients outweigh the potential risks (eg, of surgical complications, immunosuppression, opportunistic infections).

For individuals who have hand and upper-extremity amputation(s) who receive composite tissue allotransplantation, the evidence includes a small case series, several systematic reviews of case series, and a nonrandomized comparative study. Relevant outcomes are functional outcomes, quality of life, resource utilization, and treatment-related mortality and morbidity. The available studies on composite tissue allotransplantation of the hand have suggested that the surgery is technically feasible. The only study comparing outcomes in patients who had hand transplants with those who received prostheses included 12 patients. It found no differences between groups in functional outcomes and little difference in the quality of life. Given the limited number of patients worldwide who have undergone the procedure and the limited amount of data comparing outcomes with the best available prosthetics, the evidence is not sufficiently robust to determine whether the potential benefits to patients outweigh the potential risks (eg, of surgical complications, immunosuppression, opportunistic infections). The evidence is insufficient to determine the effects of the technology on health outcomes.

Population Reference No. 2 Policy Statement
[ ] MedicallyNecessary
[ x] Investigational
[ ] Not Medically Necessary

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Society for Surgery of the Hand

In 2013, the American Society for Surgery of the Hand published a position statement on hand transplantation.8, The Society recognized that hand transplantation is an alternative to prostheses and rehabilitation in appropriately selected patients, yet the guidelines still considered hand transplantation an «innovative intervention.» The statement emphasized the need for further advances in the areas of patient selection, surgical technique, and immunosuppression and recommended that, at this time, the procedure be carried out only in centers with extensive experience in both hand surgery and solid organ transplantation.

National Institute for Health and Care Excellence

In 2011, the National Institute for Health and Care Excellence published guidance on hand allotransplantation.9, The guidance stated that the quantity of current evidence on the efficacy and safety of hand allotransplantation was inadequate.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 1.

Table 1. Summary of Key Trials

NCT No.
Trial Name
Planned Enrollment
Completion Date

Ongoing

NCT01459107
Human Upper Extremity Allotransplantation
30
Jun 2026

NCT: national clinical trial.

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

References

Infante-Cossio P, Barrera-Pulido F, Gomez-Cia T, et al. Facial transplantation: a concise update. Med Oral Patol Oral Cir Bucal. Mar 01 2013; 18(2): e263-71. PMID 23229268
Sosin M, Rodriguez ED. The Face Transplantation Update: 2016. Plast Reconstr Surg. Jun 2016; 137(6): 1841-1850. PMID 27219239
Smeets R, Rendenbach C, Birkelbach M, et al. Face transplantation: on the verge of becoming clinical routine?. Biomed Res Int. 2014; 2014: 907272. PMID 25009821
Fischer S, Kueckelhaus M, Pauzenberger R, et al. Functional outcomes of face transplantation. Am J Transplant. Jan 2015; 15(1): 220-33. PMID 25359281
Shores JT, Brandacher G, Lee WPA. Hand and upper extremity transplantation: an update of outcomes in the worldwide experience. Plast Reconstr Surg. Feb 2015; 135(2): 351e-360e. PMID 25401735
Petruzzo P, Dubernard JM. The International Registry on Hand and Composite Tissue allotransplantation. Clin Transpl. 2011: 247-53. PMID 22755418
Salminger S, Sturma A, Roche AD, et al. Functional and Psychosocial Outcomes of Hand Transplantation Compared with Prosthetic Fitting in Below-Elbow Amputees: A Multicenter Cohort Study. PLoS One. 2016; 11(9): e0162507. PMID 27589057
American Society for Surgery of the Hand Council. ASSH position statement on hand transplantation 2013. J Hand Surg Am. Nov 2013; 38(11): 2234-5. PMID 24206988
National Institute for Health and Care Excellence (NICE). Hand allotransplantation [IPG383]. 2011; https://www.nice.org.uk/guidance/ipg383. Accessed July 16, 2021

CODES

Codes
Number
Description

CPT
26989
unlisted procedure, hands or fingers (no specific code may use)

ICD-10-CM

Investigational for all diagnoses

ICD-10-PCS

ICD-10-PCS codes are only used for inpatient services

0WY20Z0
Transplantation, face, open, allogeneic

0XYJ0Z0, 0XYK0Z0
Transplantation, hand, open, allogeneic (codes for right and left)

Type of service
Surgery

Place of service
Inpatient

Applicable Modifiers

As per Correct Coding Guidelines

Policy History

Date
Action
Description

9/07/2022
Annual Review
Policy updated with literature review through May 16, 2022; no references added. Policy statement unchanged.

9/16/2021
Annual Review
Policy updated with literature review through May 17, 2021; no references added. Policy statement unchanged.

9/10/2020
New Policy for TS
Policy adopted from BCBS with literature review through May 22, 2020; no references added. Policy statement unchanged.


Amniotic Membrane and Amniotic Fluid

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.


Islet Transplantation

Autologous pancreas islet transplantation may be considered medically necessary as an adjunct to a total or near-total pancreatectomy in patients with chronic pancreatitis.Allogeneic islet transplantation is considered investigational for the treatment of type 1 diabetes.

Islet transplantation is considered investigational in all other situations.


Heart/Lung Transplant

Heart/lung transplantation may be considered medically necessary for carefully selected patients with end-stage cardiac and pulmonary disease including, but not limited to, one of the following diagnoses:irreversible primary pulmonary hypertension with heart failure

nonspecific severe pulmonary fibrosis, with severe heart failure

Eisenmenger complex with irreversible pulmonary hypertension and heart failure

cystic fibrosis with severe heart failure

chronic obstructive pulmonary disease with heart failure

emphysema with severe heart failure

pulmonary fibrosis with uncontrollable pulmonary hypertension or heart failure.

Heart/lung retransplantation after a failed primary heart/lung transplant may be considered medically necessary in patients who meet criteria for heart/lung transplantation.

Heart/lung transplantation is considered investigational in all other situations.


Lung and Lobar Lung Transplant

A lung transplant consists of replacing all or part of diseased lungs with healthy lung(s) or lobes. Transplantation is an option for patients with end-stage lung disease.


Heart Transplant

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.


Liver Transplant and Combined Liver-Kidney Transplant

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.


Allogeneic Pancreas Transplant

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.


Isolated Small Bowel Transplant

A small bowel transplant may be performed as an isolated procedure or in conjunction with other visceral organs, including the liver, duodenum, jejunum, ileum, pancreas, or colon. Isolated small bowel transplant is commonly performed in patients with short bowel syndrome. Small bowel/liver transplants and multivisceral transplants are considered in evidence review 07.003.010.


Surgical Left Atrial Appendage Occlusion Devices for Stroke Prevention in Atrial Fibrillation

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.


Magnetic Resonance Imaging-Targeted Biopsy of the Prostate

Before a transrectal ultrasound-guided biopsy, a magnetic resonance imaging (MRI) scan can be used to pinpoint the location of suspicious lesions in the prostate. Use of MRI permits a targeted biopsy (as opposed to a blind biopsy, which is the current standard of care). The use of an MRI-guided prostate biopsy serves 2 functions: (1) to identify areas in the prostate that could harbor a high-grade tumor; and (2) to divert attention from any clinically insignificant cancers not needing treatment. In accomplishing the secondary function, patients are placed into 1 of 2 categories: those only needing active surveillance and those needing definitive intervention.


Prostatic Urethral Lift

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 patient 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,
Patient does not have urinary retention, urinary tract infection, or recent prostatitis (within past year); AND,
Patient has had appropriate testing to exclude diagnosis of prostate cancer; AND,
Patient 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.


Synthetic Cartilage Implants for Joint Pain

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


Hydrogel Spacer use During Radiotherapy for Prostate Cancer

Hydrogel spacer use during radiotherapy for prostate cancer is considered investigational.Use of a hydrogel spacer for any other indication is investigational.


Percutaneous Electrical Nerve Stimulation and Pecutaneous Neuromodulation Therapy

Percutaneous electrical neurostimulation or percutaneous neuromodulation therapy is considered investigational.


Ablation Procedures for Peripheral Neuromas

Minimally invasive ablation procedures, including intralesional alcohol injection, radiofrequency ablation, and cryoablation, are considered investigational for the treatment of Morton and other peripheral neuromas.


ROUTINE CARE SERVICES OF THE FOOT

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


Laminectomy

Cervical laminectomy may be considered medically necessary when ALL of the following conditions are met:Spinal cord or nerve root compression due to one of the following conditions:

Spinal stenosis (with or without spondylolisthesis)

Ossification of the posterior longitudinal ligament or the yellow ligament; or hypertrophy of the ligamentumflavum.

Signs and/or symptoms that meet at least one of the following criteria:

Neurologic deficits that are rapidly progressive; OR

Symptoms of cervical myelopathy (see Policy Guidelines section) or cervical cord compression (with or without radiculopathy); OR

Persistent debilitating pain that is refractory to at least 6 weeks of conservative nonsurgical therapy (See Policy Guidelines section).

Imaging studies (preferably magnetic resonance imaging) with findings of spinal cord compression, nerve root compression, and/ormyelographic changes, at a level corresponding to the patient’s signs and symptoms.

Lumbar laminectomy may be considered medically necessary when ALL of the following conditions are met:

Spinal cord or nerve root compression due to spinal stenosis (with or without spondylolisthesis);

Signs and/or symptoms that meet at least one of the following criteria:

Neurologic deficits that are rapidly progressive; OR

Neurologic claudication that is persistent and refractory to at least 6 weeks of conservative nonsurgical therapy (see Policy Guidelines section); OR

Persistent debilitating pain that is refractory to at least 6 weeks of conservative nonsurgical management (see Policy Guidelines section).

Imaging studies (preferably magnetic resonance imaging) with findings of spinal cord or nerve root compression, at a level corresponding to the patient’s signs and symptoms.

Laminectomy (cervical, thoracic, lumbar) may be considered medically necessary for space-occupying lesions of the spinal cord and/or spinal canal.

Primary or metastatic tumors

Abscesses or other localized infections.

Laminectomy (cervical or lumbar) is not medically necessary for spinal stenosis when the above criteria are not met.

Laminectomy is considered investigational for all other indications.


Electromagnetic Navigational Bronchoscopy

When flexible bronchoscopy alone, or with endobronchial ultrasound, are considered inadequate to accomplish the diagnostic or interventional objective, electromagnetic navigation bronchoscopy (ENB) may be considered medically necessary to:establish a diagnosis of suspicious peripheral pulmonary lesion(s) or

place fiducial markers within lung tumor(s) prior to treatment.

Electromagnetic navigation bronchoscopy is considered investigational for use with flexible bronchoscopy for the diagnosis of mediastinal lymph nodes as well as all other uses not covered above.


Small Bowel/Liver and Multivisceral Transplant

Transplants, such as a multivisceral transplant and a small bowel and liver transplant, may be considered medically necessary for pediatric and adult patients 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.


Percutaneous Tibial Nerve Stimulation

Percutaneous tibial nerve stimulation for an initial 12-week course is considered medically necessary for individuals with non-neurogenic urinary dysfunction including overactive bladder who have both:failed behavioral therapy following an appropriate duration of 8 to 12 weeks without meeting treatment goals; and

failed pharmacologic therapy following 4 to 8 weeks of treatment without meeting treatment goals.

Maintenance therapy using monthly percutaneous tibial nerve stimulation is considered medically necessary for individuals following a 12-week initial course of percutaneous tibial nerve stimulation that resulted in improved urinary dysfunction meeting treatment goals.

Percutaneous tibial nerve stimulation is considered investigational for all other indications, including but not limited to the following:

Neurogenic bladder dysfunction

Fecal incontinence.


Automated Percutaneous and Percutaneous Endoscopic Discectomy

Automated percutaneous discectomy is considered investigational as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic, or cervical spine.Percutaneous endoscopic discectomy is considered investigational as a technique of intervertebral disc decompression in patients with back pain and/or radiculopathy related to disc herniation in the lumbar, thoracic, or cervical spine.


Bronchial Thermoplasty

Bronchial thermoplasty is a potential treatment option for patients with severe persistent asthma. It consists of radiofrequency energy delivered to the distal airways with the aim of decreasing smooth muscle mass believed to be associated with airway inflammation.


Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome

Palatopharyngoplasty (eg, uvulopalatopharyngoplasty, uvulopharyngoplasty, uvulopalatal flap, expansion sphincter pharyngoplasty, lateral pharyngoplasty, palatal advancement pharyngoplasty, relocation pharyngoplasty) may be considered medically necessary for the treatment of clinically significant obstructive sleep apnea (OSA) syndrome in appropriately select adults who have failed an adequate trial of continuous positive airway pressure (CPAP) or failed an adequate trial of an oral appliance. Clinically significant OSA is defined as those individuals who have:Apnea/Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) of 15 or more events per hour, or

AHI or RDI of at least 5 events per hour with 1 or more signs or symptoms associated with OSA (eg, excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke).

Hyoid suspension, surgical modification of the tongue, and/or maxillofacial surgery, including mandibular-maxillary advancement (MMA), may be considered medically necessary in appropriately selected adults with clinically significant OSA and objective documentation of hypopharyngeal obstruction who have failed an adequate trial of CPAP or failed an adequate trial of an oral appliance. Clinically significant OSA is defined as those individuals who have:

AHI or RDI of 15 or more events per hour, or

AHI or RDI of at least 5 events per hour with 1 or more signs or symptoms associated with OSA (eg, excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke).

Adenotonsillectomy may be considered medically necessary in pediatric individuals with clinically significant OSA and hypertrophic tonsils. Clinically significant OSA is defined as those pediatric individuals who have:

AHI or RDI of at least 5 per hour, or

AHI or RDI of at least 1.5 per hour in anindividual with excessive daytime sleepiness, behavioral problems, or hyperactivity.

Hypoglossal nerve stimulation may be considered medically necessary in adults with OSA under the following conditions:

Age ≥ 22 years; AND

AHI ≥ 15 with less than 25% central apneas; AND

CPAP failure (residual AHI ≥ 15 or failure to use CPAP ≥ 4 hr per night for ≥ 5 nights per week) or inability to tolerate CPAP; AND

Body mass index ≤ 32 kg/m2; AND

Non-concentric retropalatal obstruction on drug-induced sleep endoscopy (see Policy Guidelines).

Hypoglossal nerve stimulation may be considered medically necessary in adolescents or young adults with Down syndrome and OSA under the following conditions:

Age 10 to 21 years; AND

AHI >10 and <50 with less than 25% central apneas after prior adenotonsillectomy; AND Have either tracheotomy or be ineffectively treated with CPAP due to noncompliance, discomfort, undesirable side effects, persistent symptoms despite compliance use, or refusal to use the device; AND Body mass index ≤ 95th percentile for age; AND Non-concentric retropalatal obstruction on drug-induced sleep endoscopy (See Policy Guidelines). Surgical treatment of OSA that does not meet the criteria above would be considered not medically necessary. The following minimally invasive surgical procedures are considered investigational for the sole or adjunctive treatment of OSA or upper airway resistance syndrome: Laser-assisted palatoplasty or radiofrequency volumetric tissue reduction of the palatal tissues Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency reduction of the palatal tissues Palatal stiffening procedures including, but not limited to, cautery-assisted palatal stiffening operation, injection of a sclerosing agent, and the implantation of palatal implants Tongue base suspension All other minimally invasive surgical procedures not described above. Implantable hypoglossal nerve stimulators are considered investigational for all indications other than listed above. All interventions, including laser-assisted palatoplasty, radiofrequency volumetric tissue reduction of the palate, or palatal stiffening procedures, are considered investigational for the treatment of snoring in the absence of documented OSA; snoring alone is not considered a medical condition.


Endovascular Stent Grafts for Abdominal Aortic Aneurysms

The use of endoprostheses approved by the U.S. Food and Drug Administration (FDA) as a treatment of abdominal aortic aneurysms (AAAs) may be considered medically necessary in any of the following clinical situations:an aneurysmal diameter greater than 5.0 cm

an aneurysmal diameter of 4 to 5.0 cm that has increased in size by 0.5 cm in the last 6 months

an aneurysmal diameter that measures twice the size of the normal infrarenal aorta

a ruptured AAA (see Policy Guidelines section).

The use of endoprostheses approved by the FDA as a treatment of AAAs is considered investigational when the above criteria are not met, including but not limited to the following clinical situations:

Treatment of smaller aneurysms that do not meet the current recommended threshold for surgery

Treatment of aneurysms that do meet the recommended threshold for surgery in patients who are ineligible for open repair due to physical limitations or other factors.


Reconstructive Breast Surgery/Management of Breast Implants after Mastectomy

Coverage eligibility of breast implants for the purposes of augmentation may depend on contract language. After reconstructive breast surgery on one side, insertion of an implant on the contralateral, normal side is rarely necessary to achieve symmetry.Reconstructive breast surgery may be considered medically necessary after a medically necessary mastectomy, accidental injury, or trauma. Medically necessary mastectomies are most typically done as treatment for cancer. Reconstruction may be performed by an implant-based approach or through the use of autologous tissue.

Explantation of a silicone gel-filled breast implant may be considered medically necessary in all cases for a documented implant rupture, infection, extrusion, Baker class IV contracture, or surgical treatment of breast cancer.

Explantation of a ruptured saline-filled breast implant may be considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes. Otherwise, indications for the explantation of a saline-filled implant are similar to those of a silicone-filled implant.

Explantation of a breast implant associated with a Baker class III contracture may be considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes.

Reconstructive breast surgery after explantation of an implant is considered medically necessary only in those individuals who had originally undergone breast implantation for reconstructive purposes.

The following indications for explantation of implants are considered investigational:

Systemic symptoms, attributed to connective tissue diseases, autoimmune diseases;

Anxiety;

Baker class III contractures in individuals with implants for cosmetic purposes;

Rupture of a saline implant in individuals with implants for cosmetic purposes;

Pain not related to contractures;

Preventive explantation in asymptomatic individuals to reduce remote risk of anaplastic large cell lymphoma;

Preventive explantation in asymptomatic individuals to reduce remote risk of B cell lymphoma.


Whole Gland Cryoablation of Prostate Cancer

Cryoablation, also known as cryotherapy or cryosurgery, is a procedure that attacks cancer cells using extremely cold gas. This technique can be used to treat prostate cancer by percutaneously inserting thin, needle-like cryoprobes into the prostate gland and then sending very cold gas down the cryoprobes to rapidly freeze and thaw the tissue, causing necrosis. This review evaluates evidence on the use of total (whole gland, definitive therapy) cryoablation. Subtotal (focal) cryoablation and alternative procedures are considered in evidence review 8.01.61.


 Transurethral Water Vapor Thermal Therapy and Transurethral Water Jet Ablation (Aquablation) for Benign Prostatic Hypertrophy

Transurethral water vapor thermal therapy and transurethral waterjet ablation (aquablation) have been investigated as minimally invasive alternatives to transurethral resection of the prostate, considered the traditional standard treatment for benign prostatic hyperplasia. Transurethral water vapor thermal therapy uses radiofrequency-generated water vapor (~103°C) thermal energy based on the thermodynamic properties of convective versus conductive heat transfer to ablate prostate tissue. Aquablation cuts tissue by using a pressurized jet of fluid delivered to the prostatic urethra.


Endovascular Stent Grafts for Disorders of the Thoracic Aorta

Thoracic endovascular aortic repair (TEVAR) involves the percutaneous placement of a stent graft in the descending thoracic or thoracoabdominal aorta. It is a less invasive alternative than open surgery for the treatment of thoracic aortic aneurysms (TAAs), dissections, or rupture, and thus has the potential to reduce the morbidity and mortality of open surgery. Endovascular stenting may also be an alternative to medical therapy for treating TAAs or thoracic aorta dissections.


Cryoablation of Tumors Located in the Kidney, Lung, Breast, Pancreas, or Bone

Cryosurgical ablation (hereafter referred to as cryosurgery or cryoablation) involves freezing of target tissues; this is most often performed by inserting a coolant-carrying probe into the tumor. Cryosurgery may be performed as an open surgical technique or as a closed procedure under laparoscopic or ultrasound guidance.


Adjunctive Techniques for Screening and Surveillance of Barrett Esophagus and Esophageal Dysplasia

Wide-area transepithelial sampling with three-dimensional computer-assisted analysis (WATS3D) is considered investigational for all indications, including but not limited to the screening and surveillance of Barrett esophagus and esophageal dysplasia.


Radioembolization for Primary and Mestastatic Tumors of the Liver

Radioembolization may be considered medically necessary to treat primary hepatocellular carcinoma that is unresectable and limited to the liver (see Policy Guidelines section).Radioembolization may be considered medically necessary in primary hepatocellular carcinoma as a bridge to liver transplantation.

Radioembolization may be considered medically necessary to treat primary intrahepatic cholangiocarcinoma in patients with unresectable tumors.

Radioembolization may be considered medically necessary to treat hepatic metastases from neuroendocrine tumors (carcinoid and noncarcinoid) with diffuse and symptomatic disease when systemic therapy has failed to control symptoms.

Radioembolization may be considered medically necessary to treat unresectable hepatic metastases from colorectal carcinoma, melanoma (ocular or cutaneous), or breast cancer that are both progressive and diffuse, in patients with liver-dominant disease who are refractory to chemotherapy or are not candidates for chemotherapy or other systemic therapies.

Radioembolization is considered investigational for all other hepatic metastases except as noted above.

Radioembolization is considered investigational for all other indications not described above.


Therapeutic Radiopharmaceuticals in Oncology

Lutetium 177Initial TreatmentLutetium 177 (Lu 177) dotatate treatment is considered medically necessary when conditions 1 through 8 are met:

Individual is an adult (≥18 years of age).

Individual has documented low or intermediate grade (Ki-67 index ≤20%), locally advanced or metastatic, gastroenteropancreatic (including foregut, midgut, and hindgut) or metastatic bronchopulmonary or thymus neuroendocrine tumor.

Individual has documented somatostatin receptor expression of a neuroendocrine tumor as detected by somatostatin receptor-based imaging (see Policy Guidelines).

Individual has documented disease progression while on octreotide long-acting release or lanreotide therapy.

Individual is not receiving long-acting somatostatin analogues (e.g., octreotide long-acting release or lanreotide) for at least 4 weeks prior to initiating Lu 177 dotatate and has discontinued use of short-acting octreotide for at least 24 hours prior to initiating Lu 177 dotatate.

Individual does not have severe renal impairment (creatinine clearance <30 mL/min). Individual has adequate bone marrow and hepatic function as determined by the treating physician. Individual has documented Karnofsky Performance Status score of 60 or greater. Continuation of Treatment Continuation of Lu 177 dotatate is considered medically necessary when conditions 1 through 5 are met: No recurrent grade 2, 3, or 4 thrombocytopenia (see Table PG1). No recurrent grade 3 or 4 anemia and neutropenia (see Table PG1). No recurrent hepatotoxicity (see definition of hepatotoxicity in the Policy Guidelines section). No recurrent grade 3 or 4 nonhematologic toxicity (see Table PG1). No renal toxicity requiring a treatment delay of 16 weeks or longer (see definition of renal toxicity in the Policy Guidelines section). Lu 177 dotatate treatment is considered investigational in all other situations in which the above criteria are not met. Lu 177 dotatate treatment greater than a total of 4 doses as per the U.S. Food and Drug Administration (FDA)-approved regimen is considered investigational. Lu 177 dotatate treatment is considered investigational for all other indications including pheochromocytoma and paraganglioma. Iobenguane I 131 Iobenguane I 131 is considered medically necessary when conditions 1 through 5 are met: Individual has documented iobenguane scan positive, locally advanced or metastatic pheochromocytoma and paraganglioma. Individual is 12 years or older. Individual has progressed on prior therapy for pheochromocytoma or paraganglioma OR is not a candidate for chemotherapy. Individual does not have severe renal impairment (creatinine clearance <30 mL/min). Individual has platelet count greater than 80,000/mcL OR absolute neutrophil count greater than 1,200/mcL. Iobenguane I 131 treatment is considered investigational for all other indications including neuroblastoma and gastroenteropancreatic neuroendocrine tumors. Use of iobenguane I 131 not in accordance with FDA approved dosing (first dosimetric dose followed by 2 therapeutic doses administered 90 days apart) is considered investigational. See Policy Guidelines below.


Selected Positron Emission Tomography Technologies for Evaluation of Alzheimer Disease

Amyloid beta imaging with positron emission tomography (PET) to predict conversion to Alzheimer disease is considered investigational.Amyloid beta imaging with PET as an adjunct to clinical diagnosis in patients with dementia is considered investigational.

Amyloid beta imaging with PET to select patients with mild cognitive impairment or mild dementia due to Alzheimer disease for amyloid beta targeting plaque-therapy is considered investigational.

Amyloid beta imaging with PET to evaluate patients with mild cognitive impairment or mild dementia due to Alzheimer disease for continuation of amyloid beta plaque-targeting therapy is considered investigational.

PET Imaging with fluorine 18 fluorodeoxyglucose (FDG-PET) as an adjunct to clinical diagnosis in patients with dementia is considered investigational.

All other uses of amyloid beta imaging with PET are considered investigational.


FDG Using Camera-Based Imaging (FDG-SPECT)

SPECT is considered for payment to demonstrate myocardial viability.SPECT is not considered for payment in:

· Bone and joints – to differentiate between infectious, neo-plastic, avascular and traumatic processes

· Brain tumors-to differentiate between lymphomas from infections such as toxoplasmosis, particularly in the immunosuppressed patient

Hepatic hemangioma uses red cells marked to define lesions identified by other means

· Location of abscesses / infections / inflammation in soft tissues or in cases of fever of unknown origin

· Neuroendocrine tumors (eg adenomas, carcinoid, pheochromocytomas, tumors secreting intestinal vasoactive peptides (VIP), thyroid carcinoma, adrenal tumors.

· Location of parathyroid

SPECT is not considered for payment for any other indication, including but not limited to the following:

· Attention deficit hyperactivity disorder

· Chronic fatigue syndrome

· Colorectal carcinoma

· Sweep in the transport of dopamine- all indications

· Malignities except those listed above

· Neuropsychiatric disorders without evidence of cerebrovascular disease

· Pervasive developmental disorders

· Prostate carcinoma

· scintimamography for breast cancer


Magnetic Resonance Angiography of Vessels of the Head, Neck, Abdomen, Pelvis, and Lower Extremity

MRA of the head may be considered medically necessary for the assessment of: patients suspected of having steno-occlusive disease of the mid or large size intracranial arteries; patients suspected of having cerebral aneurysm;
 patients suspected of having intracranial vascular malformation;
 patients suspected of having cerebral venous sinus compression or thrombosis;
 patients with pulsatile tinnitus;

MRA of the neck may be considered medically necessary for the assessment of:
 patients suspected of having carotid stenosis or occlusion;
 patients suspected of having cervicocranial arterial dissection.

MRA of the abdomen/pelvis may be considered medically necessary for the assessment of patients with the following clinical indications in whom angiography would otherwise be indicated and in whom a negative MRA would obviate the need for angiography:
 patients suspected of having atherosclerotic renal artery stenosis;
 patients with suspected chronic mesenteric ischemia;
 patients with abdominal aortic aneurysm who are to undergo elective repair of the aneurysm;
 patients requiring evaluation of the portal and/or hepatic venous system; patients requiring evaluation of the systemic venous system.

MRA of the pelvis/lower extremities may be considered medically necessary for the assessment of patients with the following clinical indications:
 patients with suspected atherosclerotic disease of the lower extremity in whom angiography would otherwise be indicated and in whom MRA would obviate the need for angiography;
 patients with known atherosclerotic disease of the lower extremity who are being evaluated for bypass surgery and in whom angiography fails to identify runoff vessels suitable for bypass.

MRA may be considered medically necessary in the evaluation of potential renal donors for the presence of accessory renal arteries.


Brachytherapy for Clinically Localized Prostate Cancer Using Permanently Implanted Seeds

Brachytherapy using permanent transperineal implantation of radioactive seeds may be considered medically necessary for the treatment of localized prostate cancer when used in conjunction with external-beam radiotherapy or as monotherapy (see Policy Guidelines section).Focal prostate brachytherapy is considered investigational in the treatment of prostate cancer.


Stereotactic Radiosurgery and Stereotactic Body Radiotherapy

Stereotactic radiosurgery using a gamma-ray or linear accelerator unit may be considered medically necessary for the following indications:

  • arteriovenous malformations;
  • trigeminal neuralgia refractory to medical management;
  • mesial temporal lobe epilepsy refractory to medical management when standard alternative surgery is not an option;
  • acoustic neuromas;
  • pituitary adenomas;
  • nonresectable, residual, or recurrent meningiomas;
  • craniopharyngiomas;
  • glomus jugulare tumors;
  • malignant neoplastic intracranial lesion(s) (eg, gliomas, astrocytomas);
  • solitary or multiple brain metastases in individuals having good performance status and no active systemic disease (defined as extracranial disease that is stable or in remission) (see Policy Guidelines section);
  • uveal melanoma.

Stereotactic body radiotherapy may be considered medically necessary for the following indications:

  • primary or metastatic spinal or vertebral body tumors in individuals who have received prior spinal radiotherapy;
  • spinal or vertebral metastases that are radioresistant (eg, renal cell carcinoma, melanoma, sarcoma);
  • individuals with stage T1 or T2a non-small cell lung cancer (not >5 cm) showing no nodal or distant disease and who are not candidates for surgical resection;
  • primary or metastatic tumors of the liver as an alternative locoregional treatment for individuals with inoperable primary or metastatic lesions;
  • primary renal cell carcinoma in individuals who are not good surgical candidates or who have metastatic renal cell carcinoma;
  • oligometastases involving the lung, adrenal glands, and bone (other than spine or vertebral body).

When stereotactic radiosurgery or stereotactic body radiotherapy are performed using fractionation (defined in the Policy Guidelines section) for the medically necessary indications described above, it may be considered medically necessary.

Stereotactic radiosurgery is investigational for other applications including, but not limited to, the treatment of functional disorders (other than trigeminal neuralgia), including chronic pain and tremor.

Stereotactic body radiotherapy is investigational for prostate cancer, pancreatic adenocarcinoma, and other conditions except as outlined in the policy statements above.


 Periureteral Bulking Agents as a Treatment of Vesicoureteral Reflux

Periureteral bulking agents may be considered medically necessary as a treatment of vesicoureteral reflux grades II, III, or IV when medical therapy has failed and surgical intervention is otherwise indicated.The use of bulking agents as a treatment of vesicoureteral reflux in other clinical situations is considered investigational.


 Somatic Biomarker Testing (Including Liquid Biopsy) for Targeted Treatment and Immunotherapy in Metastatic Colorectal Cancer (KRAS, NRAF, BRAF, MMR/MSI, HER2, and TMB)

KRAS variant analysis of tumor tissue may be considered medically necessary for individuals with metastatic colorectal cancer to select individuals for treatment with FDA-approved therapies.All other uses of KRAS variant testing of tumor tissue to guide colorectal cancer targeted therapy or immunotherapy are considered investigational.

NRAS variant analysis of tumor tissue may be considered medically necessary for individuals with metastatic colorectal cancer to select individuals for treatment with FDA-approved therapies.

All other uses of NRAS variant testing of tumor tissue to guide colorectal cancer targeted therapy or immunotherapy are considered investigational.

BRAF variant analysis of tumor tissue may be considered medically necessary for individuals with metastatic colorectal cancer who are found to be wild-type on KRAS and NRAS variant analysis to guide management decisions, and to select individuals for treatment with FDA-approved therapies.

All other uses of BRAF variant testing of tumor testing to guide colorectal cancer targeted therapy or immunotherapy are considered investigational.

Mismatch repair/microsatellite instability testing may be considered medically necessary to select individuals for treatment with FDA-approved therapies.

Other uses of mismatch repair/microsatellite instability variant testing of colorectal tumor tissue for guiding targeted therapy or immunotherapy are considered investigational (see Policy Guidelines).

Human epidermal growth factor receptor 2 testing is considered investigational to predict treatment response to immunotherapy in patients with metastatic colorectal cancer.

Tumor mutational burden testing to predict response to immunotherapy in patients with metastatic colorectal cancer is considered investigational.

Circulating tumor DNA testing (liquid biopsy) to guide treatment in patients with metastatic colorectal cancer is considered investigational.

Testing for other variants may become available between policy updates (see Policy Guidelines).


Radiofrequency Ablation of Primary or Metastatic Liver Tumors

Radiofrequency ablation of primary, inoperable (eg, due to location of lesion[s] and/or comorbid conditions), hepatocellular carcinoma may be considered medically necessary under the following conditions:as a primary treatment of hepatocellular carcinoma meeting the Milan criteria (a single tumor of ≤5 cm or up to 3 nodules <3 cm). as a bridge to transplant, where the intent is to prevent further tumor growth and to maintain an individual's candidacy for liver transplant. Radiofrequency ablation as a primary treatment of inoperable hepatic metastases may be considered medically necessary under the following conditions: metastases are of colorectal origin and meet the Milan criteria (a single tumor of ≤5 cm or up to 3 nodules <3 cm). metastases are of neuroendocrine origin and systemic therapy has failed to control symptoms. Radiofrequency ablation of primary, inoperable, hepatocellular carcinoma is considered investigational under the following conditions: when there are more than 3 nodules or when not all sites of tumor foci can be adequately treated. when used to downstage (downsize) hepatocellular carcinoma in individuals being considered for liver transplant. Radiofrequency ablation of primary, operable hepatocellular carcinoma is investigational. Radiofrequency ablation for hepatic metastasis is considered investigational for: hepatic metastases from colorectal cancer or neuroendocrine tumors that do not meet the criteria above; and for hepatic metastases from other types of cancer except colorectal cancer or neuroendocrine tumors.


Risk-Reducing Mastectomy

Risk-reducing mastectomy may be considered medically necessary in patients at high risk of breast cancer. (For definitions of risk levels, see Policy Guidelines section.)Risk-reducing mastectomy is considered investigational for all other indications, including but not limited to contralateral risk-reducing mastectomy in women with breast cancer who do not meet high-risk criteria.


Saturation Biopsy for Diagnosis, Staging, and Management of Prostate Cancer

Saturation biopsy is considered investigational in the diagnosis, staging, and management of prostate cancer.


Laser Treatment of Port Wine Stains

Laser treatment of port wine stains in the presence of functional impairment related to the port wine stains may be considered medically necessary. (See Benefit Application section regarding reconstructive services.) Treatment of port wine stains with lasers in combination with photodynamic therapy or topical angiogenesis inhibitors is considered investigational.


Bronchial Valves

Bronchial valves are considered investigational in all situations including, but not limited to:Treatment of prolonged air leaks, and

Treatment for patients with chronic obstructive pulmonary disease or emphysema.


Lung Volume Reduction Surgery for Severe Emphysema

Lung volume reduction surgery as a treatment for emphysema may be considered medically necessary in patients who meet all of the following criteriaa:Predominantly upper-lobe emphysema with hyperinflation and heterogeneity (ie, target areas for removal)

Forced expiratory volume in 1 second (FEV1):

For patients who are younger than 70 years of age, FEV1 must be no more than 45% of the predicted value.

For patients who are 70 years of age or older, FEV1 must be no more than 45% of the predicted value and 15% or more of the predicted value.

Marked restriction in activities of daily living, despite maximal medical therapy

Age younger than 75 years

Acceptable nutrition status (ie, 70% to 130% of ideal body weight)

Ability to participate in a vigorous pulmonary rehabilitation program

No coexisting major medical problems that would significantly increase operative risk

Willingness to undertake the risk of morbidity and mortality associated with lung volume reduction surgery

Abstinence from cigarette smoking for at least 4 months.

Lung volume reduction surgery is considered investigational in all other patients.

a Patient selection criteria are based on the National Emphysema Treatment Trial.


Transcatheter Pulmonary Valve Implantation

Transcatheter pulmonary valve implantation with a Food and Drug Administration-approved valve is considered medically necessary for individuals with congenital heart disease and current right ventricular outflow tract obstruction (RVOT) or regurgitation including the following indications:Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with at least moderate pulmonic regurgitation;

Individuals with native or patched RVOT with at least moderate pulmonic regurgitation;

Individuals with right ventricle-to-pulmonary artery conduit with or without bioprosthetic valve with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg); or

Individuals with native or patched RVOT with pulmonic stenosis (mean RVOT gradient at least 35 mm Hg).

Transcatheter pulmonary valve implantation is considered investigational for all other indications.


Digital Health Technologies: Diagnostic Applications

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.


Total Artificial Hearts and Implantable Ventricular Assist Devices

Long-Term DevicesDestination Therapy

Implantable VADs with FDA approval or clearance may be considered medically necessary as destination therapy with end-stage heart failure adult patients who meet the following criteria:

New York Heart Association (NYHA) Class III heart failure with dyspnea upon mild physical activity or NYHA Class IV;

Left ventricular ejection fraction ≤ 25%;

Inotrope-dependent; OR cardiac index <2.2 liters/min/m2, while not on inotropes and also meeting one of the following: On optimal medical management, based on current heart failure practice guidelines for at least 45 of the last 60 days and are failing to respond OR Advanced heart failure for at least 14 days and dependent on intra-aortic balloon pump for ≥7 days. Short-Term Devices Bridge to Transplantation Implantable ventricular assist devices (VADs) with U.S. Food and Drug Administration (FDA) approval or clearance may be considered medically necessary as a bridge to heart transplantation for patients who are currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, or are undergoing evaluation to determine candidacy for heart transplantation. Implantable VADs with FDA approval or clearance, including humanitarian device exemptions, may be considered medically necessary as a bridge to heart transplantation in children 16 years old or younger who are currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, or are undergoing evaluation to determine candidacy for heart transplantation. Total artificial hearts (TAHs) with FDA approved devices may be considered medically necessary as a bridge to heart transplantation for patients with biventricular failure who have no other reasonable medical or surgical treatment options, who are ineligible for other univentricular or biventricular support devices, and are currently listed as heart transplantation candidates or are undergoing evaluation to determine candidacy for heart transplantation, and not expected to survive until a donor heart can be obtained. Postcardiotomy Setting/Bridge to Recovery Implantable VADs with FDA approval or clearance may be considered medically necessary in the postcardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass. Other Indications Other applications of implantable VADs or TAHs are considered investigational, including, but not limited to, the use of TAHs as destination therapy. The use of non-FDA-approved or cleared implantable VADs or TAHs is considered investigational. Percutaneous VADs are considered investigational for all indications.


Electrocardiography (EKG, ECG)

1.  EKG services are covered diagnostic tests when there are documented signs and symptoms or other clinical indications for providing the service. EKG services should not routinely be performed as part of a preventive exam unless the member has signs and symptoms of coronary heart disease, family history or other clinical indications at the visit that would justify the test.2. Billing separately from the interpretation of ECG made and ordered as part of a visit or consultation is considered for payment.

3. The insured is not responsible for payment, when the EKG is denied for not being medically reasonable.

4. Code 93041 (Rhythm plotting; no interpretation, no report) is considered for payment only to authorized suppliers.

5. The production of the plot, if done in the office of a doctor and another provider (also a participant) interprets it, will be paid to the first, the production (93005) and to the                second the interpretation (93010).

6. If the code 93041 is produced in the hospital, it is not considered for payment, since the production of the code 93041 is a covered service in the hospital contract.

7. Electrocardiographic monitoring is considered for payment at:

a) Arrhythmias; or at the beginning of any treatment therapy for arrhythmias.

b) As a treatment to monitor:

1) pulse irregularities

2) chest pain

3) palpitations

4) tachyarrhythmias

5) bradyarrhythmias

6) syncope

Electrocardiograms associated with the Stress Test and the Holter

Billing codes 93000-93010 (electrocardiogram) are included in the payment of the Holter (93224) and in the stress test (Stress Test 93015). If you have performed an electrocardiogram within a period of six weeks prior to the Holter or Stress Test, payment of the electrocardiogram will be denied when invoiced with these services.

Electrocardiograms associated with echocardiograms

Triple-S does not consider “rhythm strips” (ECG code 93040, 93042) for payment, since they are considered an integral part of monitoring during the echocardiographic procedure. If EKG 12 “lead” is made and documented separately from 93307, it proceeds for payment.


Cardiac Hemodynamic Monitoring for the Management of Heart Failure in the Outpatient Setting

In the ambulatory care and outpatient setting, cardiac hemodynamic monitoring for the management of heart failure using implantable direct pressure monitoring of the pulmonary artery, thoracic bioimpedance, inert gas rebreathing, and arterial pressure during the Valsalva maneuver is considered investigational


Leadless Cardiac Pacemakers

The Micra transcatheter pacing system may be considered medically necessary in patients when both conditions below are met:The patient has symptomatic paroxysmal or permanent high-grade arteriovenous block or symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia or sinus pauses);

The patient has a significant contraindication precluding placement of conventional single-chamber ventricular pacemaker leads such as any of the following:

History of an endovascular or cardiovascular implantable electronic device (CIED) infection or who are at high risk for infection

Limited access for transvenous pacing given venous anomaly, occlusion of axillary veins or planned use of such veins for a semi-permanent catheter or current or planned use of an AV fistula for hemodialysis

Presence of a bioprosthetic tricuspid valve.

The Micra transcatheter pacing system is considered investigational in all other situations in which the above criteria are not met.


Transcatheter Arterial Chemoembolization to Treat Primary or Metastatic Liver Malignancies

Transcatheter arterial chemoembolization of the liver may be considered medically necessary:to treat hepatocellular cancer that is unresectable but confined to the liver and not associated with portal vein thrombosis and liver function not characterized as Child-Pugh class C

as a bridge to transplant in patients with hepatocellular cancer where the intent is to prevent further tumor growth and to maintain a patient’s candidacy for liver transplant (see Policy Guidelines section)

to treat liver metastasis in symptomatic patients with metastatic neuroendocrine tumor whose symptoms persist despite systemic therapy and who are not candidates for surgical resection

to treat liver metastasis in patients with liver-dominant metastatic uveal melanoma.

Transcatheter arterial chemoembolization of the liver is considered investigational:

as neoadjuvant or adjuvant therapy in hepatocellular cancer that is considered resectable

as part of combination therapy (with radiofrequency ablation) for resectable or unresectable hepatocellular carcinoma

to treat unresectable cholangiocarcinoma

to treat liver metastases from any other tumors or to treat hepatocellular cancer that does not meet the criteria noted above, including recurrent hepatocellular carcinoma

to treat hepatocellular tumors prior to liver transplantation except as noted above.


Hyperthermic Intraperitoneal Chemotherapy for Select Intra-Abdominal and Pelvic Malignancies

Cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC) at the time of surgery may be considered medically necessary for the treatment of:pseudomyxoma peritonei; and

diffuse malignant peritoneal mesothelioma.

The use of HIPEC may be considered medically necessary in newly diagnosed epithelial ovarian or fallopian tube cancer at the time of interval cytoreductive surgery when ALL of the following criteria are met:

The individual has stage III disease (see Policy Guidelines);

The individual is not eligible for primary cytoreductive surgery or surgery had been performed but was incomplete and will receive neoadjuvant chemotherapy and subsequent interval debulking surgery (see Policy Guidelines); and

It is expected that complete or optimal cytoreduction can be achieved at time of the interval debulking surgery (see Policy Guidelines).

The use of HIPEC in all other settings to treat ovarian cancer, including but not limited to stage IIIC or IV ovarian cancer, is considered investigational.

Cytoreductive surgery plus HIPEC is considered investigational for:

peritoneal carcinomatosis from colorectal cancer, gastric cancer, or endometrial cancer; and

all other indications, including goblet cell tumors of the appendix.


Diagnosis of Obstructive Sleep Apnea Syndrome

A single unattended (unsupervised) home sleep apnea test with a minimum of 3 recording channels with the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; or alternatively peripheral arterial tone (PAT), oximetry, and actigraphy may be considered medically necessary in adults who are at high-risk for obstructive sleep apnea (OSA) and have no evidence of a health condition that might alter ventilation or require alternative treatment (ie, central sleep apnea, heart failure, chronic pulmonary disease, obesity hypoventilation syndrome, neuromuscular disorders with sleep-related symptoms, injurious or potentially injurious parasomnias, or narcolepsy). The Policy Guidelines section defines high pretest probability.A single unattended (unsupervised) home sleep apnea test with a minimum of recording channels as described above, may be considered medically necessary as a screening tool in individuals who are scheduled for bariatric surgery and have no evidence of a health condition that might alter ventilation or require alternative treatment (see Policy Guidelines section).

Unattended home sleep studies are considered investigational in children (<18 years of age). Repeated unattended (unsupervised) home sleep apnea test with a minimum of 3 recording channels with the following sensors: nasal pressure, chest and abdominal respiratory inductance plethysmography, and oximetry; or alternatively PAT, oximetry, and actigraphy, may be considered medically necessary in adults under the following circumstances: To assess efficacy of surgery or oral appliances or devices; OR To reevaluate the diagnosis of OSA and need for continuous positive airway pressure (CPAP) (eg, if there is a significant change in weight or change in symptoms suggesting that CPAP should be retitrated or possibly discontinued). Supervised polysomnography (PSG) performed in a sleep laboratory may be considered medically necessary in individuals with a moderate or high pretest probability of OSA in the following situations: Pediatric individuals (ie, <18 years of age); OR When individuals do not meet criteria for an unattended home sleep apnea test as described above; OR A previous home study failed to establish the diagnosis of OSA in an individual with a high pretest probability of OSA; OR A previous home study was technically inadequate; OR Failure of resolution of symptoms or recurrence of symptoms during treatment; OR When testing is done to rule out other sleep disorders such as central sleep apnea, injurious or potentially injurious parasomnias, or narcolepsy (see evidence review 2.01.99); OR Presence of a comorbidity that might alter ventilation or decrease the accuracy of a home sleep apnea test, including, but not limited to heart failure, neuromuscular disease, chronic pulmonary disease, or obesity hypoventilation syndrome. A repeated, supervised PSG performed in a sleep laboratory may be considered medically necessary in individuals who meet the criteria above for an in-laboratory PSG under the following circumstances: To initiate and titrate CPAP in adults who have: An Apnea/Hypopnea Index (AHI) or Respiratory Disturbance Index (RDI) of at least 15 events per hour, OR An AHI or RDI of at least 5 events per hour in an individual with 1 or more signs or symptoms associated with OSA (eg, excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke); Note: A split-night study, in which moderate-to-severe OSA is documented during the first portion of the study using PSG, followed by CPAP during the second portion of the study, can eliminate the need for a second study to titrate CPAP (see Policy Guidelines section for criteria to perform a split-night study). To initiate and titrate CPAP in children: In pediatric individuals, an AHI or RDI of ≥5; OR An AHI or RDI ≥1.5 in an individual with excessive daytime sleepiness, behavioral problems, or hyperactivity. To assess efficacy of surgery (including adenotonsillectomy) or oral appliances/devices. Supervised or unattended home sleep apnea tests that do not meet the above criteria are considered investigational. Multiple sleep latency testing is considered investigational in the diagnosis of OSA.


Medical Management of Obstructive Sleep Apnea Syndrome

Auto-adjusting positive airway pressure (APAP) may be considered medically necessary for the titration of pressure in individuals with clinically significant obstructive sleep apnea (OSA) defined as those who have:An Apnea/Hypopnea Index (AHI), Respiratory Disturbance Index (RDI), or Respiratory Event Index (REI) of at least 15 events per hour, OR

An AHI, RDI, or REI of at least 5 events per hour in an individual with 1 or more signs or symptoms associated with OSA (eg, excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke); OR

If there is a significant change in weight or change in symptoms suggesting that continuous positive airway pressure (CPAP) should be retitrated or possibly discontinued.

CPAP may be considered medically necessary in adult or pediatric individuals with clinically significant OSA.

Clinically significant OSA in adults is:

An AHI, RDI, or REI ≥15, OR

An AHI, RDI, or REI ≥5 in an individual with 1 or more signs or symptoms associated with OSA (e.g., excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke).

Clinically significant OSA in pediatric individuals is:

An AHI or RDI ≥5 OR

An AHI or RDI ≥1.5 in an individual with excessive daytime sleepiness, behavioral problems or hyperactivity.

Bilevel positive airway pressure (PAP) or APAP may be considered medically necessary in individuals with clinically significant OSA who have failed a prior trial of CPAP or for whom bilevel PAP is found to be more effective in the sleep lab.

Intraoral appliances (tongue-retaining devices or mandibular advancing/positioning devices) may be considered medically necessary in adults with clinically significant OSA under the following conditions:

OSA, defined by an AHI, RDI, or REI of at least 15 events per hour or an AHI, RDI, or REI of at least 5 events per hour in an individual with 1 or more signs or symptoms associated with OSA (e.g., excessive daytime sleepiness, hypertension, cardiovascular heart disease, or stroke), AND

A trial with CPAP has failed or is contraindicated, AND

The device is prescribed by a treating physician, AND

The device is custom-fitted by qualified dental personnel, AND

There is absence of temporomandibular dysfunction or periodontal disease.

Note: CPAP has been shown to have greater effectiveness than oral appliances in general. This difference in efficacy is more pronounced for individuals with severe OSA, because oral appliances have been shown to be less efficacious in individuals with severe OSA than in individuals with mild-to-moderate OSA. Therefore, it is particularly important that individuals with severe OSA have an initial trial of CPAP and that all reasonable attempts are made to continue treatment with CPAP, prior to the decision to switch to an oral appliance.

The use of CPAP, bi-level PAP, APAP, and intraoral appliances that do not meet the above criteria is considered investigational for the treatment of OSA.

The use of an abbreviated daytime sleep session for acclimation to CPAP (PAP-NAP) is considered investigational.

The use of a sleep positioning trainer with vibration is considered investigational for the treatment of positional OSA.

The use of daytime electrical stimulation of the tongue is considered investigational for the treatment of OSA.

Palate and mandible expansion devices are considered investigational for the treatment of OSA.

Nasal expiratory positive airway pressure (EPAP) and oral pressure therapy devices are considered investigational.


Autonomic Nervous System Testing

Autonomic nervous system testing, consisting of a battery of tests in several domains (see Policy Guidelines section), may be considered medically necessary when the following criteria are met:Signs and/or symptoms of autonomic dysfunction are present; AND

A definitive diagnosis cannot be made from clinical examination and routine laboratory testing alone; AND

Diagnosis of the suspected autonomic disorder will lead to a change in management or will eliminate the need for further testing.

Autonomic nervous system testing is considered investigational in all other situations when criteria are not met, including but not limited to the evaluation of the following conditions:

chronic fatigue syndrome

fibromyalgia

anxiety and other psychologic disorders

sleep apnea

allergic conditions

hypertension

screening of asymptomatic individuals

monitoring progression of disease or response to treatment.

Autonomic nervous system testing using portable automated devices is considered investigational for all indications (see Policy Guidelines section).


Digital Health Therapies for Substance Abuse

Digital health therapies for individuals with substance use disorders are considered investigational.


Digital Health Therapies for Attention Deficit/Hyperactivity Disorder

Prescription digital therapy is considered investigational for the treatment of attention-deficit/hyperactivity disorder.


Ovarian and Internal Iliac Vein Endovascular Occlusion as a Treatment of Pelvic Congestion Syndrome

Endovascular occlusion of the ovarian vein and internal iliac veins is considered investigational as a treatment of pelvic congestion syndrome.


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