Genetic testing for TP53 may be considered medically necessary to confirm a diagnosis of Li-Fraumeni syndrome under the following conditions:

In an individual who meets either the classic or the Chompret clinical diagnostic criteria for Li-Fraumeni syndrome, or

In individuals with early-onset breast cancer (age of diagnosis <31 years), or In pediatric hypodiploid acute lymphoblastic leukemia (see Policy Guidelines). Targeted TP53 familial variant testing may be considered medically necessary in an at-risk relative of a proband with a known TP53 pathogenic variant. Genetic testing for a germline TP53 variant is considered investigational for all other indications (see Policy Guidelines).

Chromosomal microarray analysis may be considered medically necessary as first-line testing in the initial evaluation (see Policy Guidelines) of individuals with any of the following:

Apparent nonsyndromic developmental delay/intellectual disability,

Autism spectrum disorder, or

Multiple congenital anomalies not specific to a well-delineated genetic syndrome.

Chromosomal microarray is considered investigational for the evaluation of all other conditions of delayed development, including, but not limited to, idiopathic growth or language delay.

Panel testing using next-generation sequencing is considered investigational in all cases of suspected genetic abnormality in children with developmental delay/intellectual disability, autism spectrum disorder, or congenital anomalies.

The use of comprehensive genomic profiling for selecting targeted cancer treatment is considered investigational.

Testing for CHEK2, ATM, and BARD1 variants in the assessment of breast cancer risk is considered investigational.

APC Testing

Genetic testing of the APC gene may be considered medically necessary in the following individuals :

At-risk relatives (see Policy Guidelines section) of patients with familial adenomatous polyposis (FAP) and/or a known APC variant.

Individuals with a differential diagnosis of attenuated FAP versus MUTYH-associated polyposis (MAP) versus Lynch syndrome. Whether testing begins with APC variants or screening for mismatch repair (MMR) variants depends on clinical presentation.

Genetic testing for APC gene variants is  investigational  for colorectal cancer (CRC) patients with classical FAP for confirmation of the FAP diagnosis.

Testing for germline APC gene variants for inherited CRC syndromes is considered investigational in all other situations.

MUTYH Testing

Genetic testing of the MUTYH gene may be considered medically necessary in the following patients:

Patients with a differential diagnosis of attenuated FAP versus MAP versus Lynch syndrome and a negative result for APC gene variants. A family history of no parents or children with FAP is consistent with MAP (autosomal recessive).

Testing for germline MUTYH gene variants for inherited CRC syndromes is considered investigational in all other situations.

MMR Gene Testing

Genetic testing of MMR genes (MLH1, MSH2, MSH6, PMS2) may be considered medically necessary in the following patients:

Individuals with CRC with tumor testing suggesting germline MMR deficiency or meeting clinical criteria for Lynch syndrome (see Policy Guidelines section).

Individuals with endometrial cancer with tumor testing suggesting germline MMR deficiency or meeting clinical criteria for Lynch syndrome (see Policy Guidelines section).

At-risk relatives (see Policy Guidelines section) of individuals with Lynch syndrome with a known pathogenic/likely pathogenic MMR gene variant.

Individuals with a differential diagnosis of attenuated FAP versus MAP versus Lynch syndrome. Whether testing begins with APC variants or screening for MMR genes depends on clinical presentation.

Individuals without CRC but with a family history meeting the Amsterdam or Revised Bethesda criteria, or documentation of 5% or higher predicted risk of the syndrome on a validated risk prediction model (e.g. MMRpro, PREMM5 or MMRpredict), when no affected family members have been tested for MMR variants

Testing for germline MMR gene variants for inherited CRC syndromes is considered investigational in all other situations.

EPCAM Testing

Genetic testing of the EPCAM gene may be considered medically necessary when any 1 of the following 3 major criteria (solid bullets) is met:

Individuals with CRC, for the diagnosis of Lynch syndrome (see Policy Guidelines section) when:

Tumor tissue shows lack of MSH2 protein expression by immunohistochemistry and individual is negative for an MSH2 germline variant; OR

Tumor tissue shows a high level of microsatellite instability and individual is negative for a germline variant in MLH1, MSH2, MSH6, and PMS2; OR

At-risk relatives (see Policy Guidelines section) of individuals with Lynch syndrome with a known pathogenic/likely pathogenic EPCAM variant; OR

Individuals without CRC but with a family history meeting the Amsterdam or Revised Bethesda criteria, or documentation of 5% or higher predicted risk of the syndrome on a validated risk prediction model (e.g. MMRpro, PREMM5 or MMRpredict), when no affected family members have been tested for MMR variants, and when sequencing for MMR variants is negative.

Testing for germline EPCAM gene variants for inherited CRC syndromes is considered investigational in all other situations.

BRAF V600E or MLH1 promoter methylation

Somatic genetic testing for BRAF V600E or MLH1 promoter methylation may be considered medically necessary to exclude a diagnosis of Lynch syndrome when the MLH1 protein is not expressed in a CRC tumor on immunohistochemical analysis.

Testing for somatic BRAF V600E or MLH1 promoter methylation to exclude a diagnosis of Lynch syndrome is considered investigational in all other situations.

SMAD4 and BMPR1A Testing

Genetic testing of SMAD4 and BMPR1A genes may be considered medically necessary when any 1 of the following major criteria (solid bullets) is met:

Individuals with a clinical diagnosis of juvenile polyposis syndrome based on the presence of any 1 of the following:

at least 5 juvenile polyps in the colon

multiple juvenile polyps found throughout the gastrointestinal tract

any number of juvenile polyps in a person with a known family history of juvenile polyps.

At-risk relative of a patient suspected of or diagnosed with juvenile polyposis syndrome.

Testing for germline SMAD4 and BMPR1A gene variants for inherited CRC syndromes is considered investigational in all other situations.

STK11 Testing

Genetic testing for STK11 gene variants may be considered medically necessary when any 1 of the following major criteria (solid bullets) is met:

Individuals with a clinical diagnosis of Peutz-Jeghers syndrome based on the presence of any 2 of the following:

presence of 2 or more histologically confirmed Peutz-Jeghers polyps of the gastrointestinal tract.

characteristic mucocutaneous pigmentation of the mouth, lips, nose, eyes, genitalia, or fingers

family history of Peutz-Jeghers syndrome.

At-risk relative of anindividual suspected of or diagnosed with Peutz-Jeghers syndrome.

Testing for germline STK11 gene variants for inherited CRC syndromes is considered investigational in all other situations.

Other Variants

Genetic testing of all other genes for an inherited CRC syndrome is considered investigational.

Genetic Counseling

Pre- and post-test genetic counseling may be considered medically necessary as an adjunct to the genetic testing itself.

Cytologic analysis of epithelial cells from nipple aspirations as a technique to assess breast cancer risk and manage patients at high risk of breast cancer is considered investigational. Techniques of collecting nipple aspiration fluid include, but are not limited to, ductal lavage and suction.

Genetic testing should be performed in a setting that has suitably trained health care providers who can give appropriate pre- and post-test 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, BRCA2, and PALB2 variants in cancer-affected individuals may be considered medically necessary under any of the following circumstances:

Individuals with any close blood relative with a known BRCA1, BRCA2, or PALB2 pathogenic/likely pathogenic variant (see Policy Guidelines for definitions and for testing strategy).

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 years with:

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.

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 or without cancer and 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 of cancer-affected individuals or 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).

Genetic testing for human hemochromatosis (HFE) gene variants may be considered medically necessary in an individual with abnormal serum iron indices indicating iron overload (see Policy Guidelines section).

Genetic testing for HFE gene variants may be considered medically necessary in individuals with a family history of hemochromatosis in a first-degree relative (see Policy Guidelines section).

Genetic testing for hereditary hemochromatosis for screening of the general population is considered investigational.

Genetic testing for genes associated with familial cutaneous malignant melanoma or associated with susceptibility to cutaneous malignant melanoma is considered investigational (see Policy Guidelines).

The use of the 21-gene reverse transcriptase-polymerase chain reaction (RT-PCR) assay (ie, Oncotype DX), EndoPredict, the Breast Cancer Index, MammaPrint, or Prosigna to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered medically necessary in women with primary, invasive, node-negative breast cancer meeting all of the following characteristics:

unilateral tumor (see Policy Guidelines);

hormone receptor-positive (ie, estrogen receptor-positive or progesterone receptor-positive);

human epidermal growth factor receptor 2-negative;

tumor size 0.6 to 1 cm with moderate or poor differentiation or unfavorable features OR tumor size larger than 1 cm;

node-negative (lymph nodes with micrometastases [≤2 mm in size] are considered node-negative for this policy statement);

who will be treated with adjuvant endocrine therapy (eg, tamoxifen, aromatase inhibitors);

when the test result aids the patient in deciding on chemotherapy (ie, when chemotherapy is a therapeutic option); AND

when ordered within 6 months after diagnosis, because the value of the test for making decisions regarding delayed chemotherapy is unknown.

The use of the MammaPrint assay to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered medically necessary in women with primary, invasive, node positive breast cancer meeting all of the following characteristics:

unilateral tumor;

hormone receptor-positive (ie, estrogen receptor-positive or progesterone receptor-positive);

human epidermal growth factor receptor 2-negative;

stage T1 or T2 or operable T3 at high clinical risk (see Policy Guidelines);

1 to 3 positive nodes (N1);

no distant metastases;

who will be treated with adjuvant endocrine therapy (eg, tamoxifen, aromatase inhibitors);

eligible for a chemotherapy regimen containing a taxane, an anthracycline, or both;

when the test result aids the patient in deciding on chemotherapy (ie, when chemotherapy is a therapeutic option); AND

when ordered within 6 months after diagnosis, because the value of the test for making decisions regarding delayed chemotherapy is unknown.

The use of Oncotype Dx to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy may be considered medically necessary in women with primary, invasive, node positive breast cancer meeting all of the following characteristics:

postmenopausal (defined as previous bilateral oophorectomy or more than 12 months since the last menstrual period and no previous hysterectomy);

unilateral tumor;

hormone receptor-positive (ie, estrogen receptor-positive or progesterone receptor-positive);

human epidermal growth factor receptor 2-negative;

stage T1 or T2 or operable T3 at high clinical risk (see Policy Guidelines);

1 to 3 positive nodes (N1);

no distant metastases;

who will be treated with adjuvant endocrine therapy (eg, tamoxifen, aromatase inhibitors);

eligible for a chemotherapy regimen containing a taxane, an anthracycline, or both;

when the test result aids the patient in deciding on chemotherapy (ie, when chemotherapy is a therapeutic option); AND

when ordered within 6 months after diagnosis, because the value of the test for making decisions regarding delayed chemotherapy is unknown.

The use of Oncotype Dx to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy in premenopausal women (defined as lass than 6 months since the last menstrual period) with primary, invasive, node positive breast cancer is considered investigational (see Policy Guidelines).

The use of EndoPredict, the Breast Cancer Index, and Prosigna to determine recurrence risk for deciding whether to undergo adjuvant chemotherapy in individuals with primary, invasive, node positive breast cancer is considered investigational.

The Oncotype DX, EndoPredict, the Breast Cancer Index, MammaPrint, and Prosigna assays should only be ordered on a tissue specimen obtained during surgical removal of the tumor and after subsequent pathology examination of the tumor has been completed and determined to meet the above criteria (ie, the test should not be ordered on a preliminary core biopsy). The test should be ordered in the context of a physician-patient discussion regarding risk preferences when the test result will aid in making decisions regarding chemotherapy.

For patients who otherwise meet the above characteristics but who have multiple ipsilateral primary tumors, a specimen from the tumor with the most aggressive histologic characteristics should be submitted for testing. It is not necessary to test each tumor; treatment is based on the most aggressive lesion (see Policy Guidelines).

All other indications for the 21-gene RT-PCR assay (ie, Oncotype DX), EndoPredict, the Breast Cancer Index, MammaPrint, and Prosigna, including to consider the length of treatment with endocrine therapy, repeat testing with same test, or combination testing with various tests, are considered investigational.

Use of a subset of genes from the 21-gene RT-PCR assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ (ie, Oncotype DX® Breast DCIS Score) to inform treatment planning after excisional surgery is considered investigational.

Use of the DCISion RT assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ to inform treatment planning after excisional surgery is considered investigational.

The use of BluePrint in conjunction with MammaPrint or alone is considered investigational.

The use of Insight TNBCtype to aid in making decisions regarding chemotherapy in women with triple-negative breast cancer is considered investigational.

Use of gene expression assays in men with breast cancer is considered investigational.

The following genetic and protein biomarkers for the diagnosis of prostate cancer are considered investigational:

Kallikrein markers (eg, 4Kscore Test)

Prostate Health Index (phi)

HOXC6 and DLX1 testing (eg, SelectMDx)

PCA3, ERG, and SPDEF RNA expression in exosomes (eg, ExoDx Prostate IntelliScore)

Autoantibodies ARF 6, NKX3-1, 5′ -UTR-BMI1, CEP 164, 3′ -UTR-Ropporin, Desmocollin, AURKAIP-1, and CSNK2A2 (eg, Apifiny)

PCA3 testing (eg, Progensa PCA3 Assay)

TMPRSS:ERG fusion genes (eg, MyProstate Score)

Gene hypermethylation testing (eg, ConfirmMDx)

Mitochondrial DNA variant testing (eg, Prostate Core Mitomics Test)

PanGIA Prostate

Candidate gene panels.

Single nucleotide variant testing for cancer risk assessment of prostate cancer is considered investigational.

El análisis de patrones proteómicos en el suero como cernimiento y detección de cáncer de ovario no se considera para pago. La Sociedad de Ginecólogos Oncólogos (SGO), en febrero de 2004, se manifestó al respecto y en su opinión el OvaCheck necesita más investigación que valide su efectividad antes de ofrecerle este producto al público. A junio de 2006 SGO no había cambiado su posición.
En relación a cáncer de próstata, a junio de 2007 no había estudios prospectivos adicionales que demostraran impacto en resultados clínicos utilizando patrones proteomicos.
En 2013 National Comprehensive Cáncer Network Guidelines tampoco abalan el uso de los patrones proteomicos.

DNA analysis of stool samples can be considered medically necessary as a screening technique for colorectal cancer in individuals at average risk of colorectal cancer.

DNA analysis of stool samples is considered investigational for all other indications.

EGFR Testing

Analysis of tumor tissue for somatic variants in exons 18 through 21 (eg, G719X, L858R, T790M, S6781, L861Q) within the epidermal growth factor receptor (EGFR) gene, may be considered medically necessary to predict treatment response to a U.S. Food and Drug Administration (FDA) -approved therapy (eg, erlotinib [Tarceva] alone or in combination with ramucirumab [Cyramza], gefitinib [Iressa], afatinib [Gilotrif], dacomitinib [Vizimpro], or osimertinib [Tagrisso]) in individuals with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous-cell non-small-cell lung cancer (NSCLC), and NSCLC not otherwise specified, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines).

Analysis of tumor tissue for somatic variants in exon 20 (eg, insertion mutations) within the EGFR gene, may be considered medically necessary to predict treatment response to an FDA-approved therapy (eg, mobocertinib [Exkivity]) in individuals with NSCLC, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines).

At diagnosis, analysis of plasma for somatic variants in exons 19 through 21 (eg, exon 19 deletions, L858R, T790M) within the EGFR gene, using an FDA-approved companion diagnostic plasma test to detect circulating tumor DNA (ctDNA) may be considered medically necessary as an alternative to tissue biopsy (see Policy Guidelines) to predict treatment response to an FDA-approved therapy in individuals with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell NSCLC, and NSCLC not otherwise specified, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines).

At progression, analysis of plasma for the EGFR T790M resistance variant for targeted therapy with osimertinib using an FDA-approved companion diagnostic plasma test to detect ctDNA may be considered medically necessary in individuals with advanced lung adenocarcinoma, large cell carcinoma, advanced squamous cell NSCLC, and NSCLC not otherwise specified, when tissue biopsy to obtain new tissue is not feasible (eg, in those who do not have enough tissue for standard molecular testing using formalin-fixed paraffin-embedded tissue, do not have a biopsy-amenable lesion, or cannot undergo biopsy), and when the individual does not have any FDA-labeled contraindications to osimertinib and it is intended to be used consistently with the FDA-approved label (see Policy Guidelines).

Analysis of somatic variants in the EGFR gene in tissue or plasma, including variants within exons 22 to 24, is considered investigational in all other situations.

ALK Testing

Analysis of tumor tissue for somatic rearrangement variants of the anaplastic lymphoma kinase (ALK) gene in tissue may be considered medically necessary to predict treatment response to an FDA-approved ALK inhibitor therapy (eg, crizotinib [Xalkori], ceritinib [Zykadia], alectinib [Alecensa], brigatinib [Alunbrig], or lorlatinib [Lorbrena]) in individuals with advanced lung adenocarcinoma or in whom an adenocarcinoma component cannot be excluded, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines ).

Analysis of plasma for somatic rearrangement variants of the ALK gene using an FDA-approved companion diagnostic plasma test to detect ctDNA may be considered medically necessary as an alternative to tissue biopsy (see Policy Guidelines) to predict treatment response to an FDA-approved ALK inhibitor therapy in individuals with NSCLC (eg, alectinib [Alcensa]), if the individual does not have any FDA-labeled contraindications to the requested agent and both the agent and ctDNA test are intended to be used consistently with their FDA-approved labels (see Policy Guidelines).

Analysis of somatic rearrangement variants of the ALK gene in tissue or plasma is considered investigational in all other situations.

BRAF V600E Testing

Analysis of tumor tissue for the somatic BRAF V600E variant may be considered medically necessary to predict treatment response to an FDA-approved BRAF and/or MEK inhibitor therapy (eg, dabrafenib [Tafinlar] and trametinib [Mekinist]), in individuals with advanced lung adenocarcinoma or in whom an adenocarcinoma component cannot be excluded, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines ).

Analysis of tumor tissue for the somatic BRAF V600E variant is considered investigational in all other situations.

Analysis of plasma for the somatic BRAF V600E variant to detect ctDNA is considered investigational as an alternative to tissue biopsy (see Policy Guidelines) to predict treatment response to BRAF and/or MEK inhibitor therapy (eg, dabrafenib [Tafinlar], trametinib [Mekinist]) in individuals with NSCLC.

ROS1 Testing

Analysis of tumor tissue for somatic rearrangement variants of the ROS1 gene may be considered medically necessary to predict treatment response to an FDA-approved ROS1 inhibitor therapy (eg, crizotinib [Xalkori] ) in individuals with advanced lung adenocarcinoma or in whom an adenocarcinoma component cannot be excluded, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines).

Analysis of tumor tissue for somatic rearrangement variants of the ROS1 gene is considered investigational in all other situations.

Analysis of plasma for somatic rearrangement variants of the ROS1 gene to detect ctDNA is considered investigational as an alternative to tissue biopsy (see Policy Guidelines) to predict treatment response to ROS1 inhibitor therapy (eg, crizotinib [Xalkori] or entrectinib ) in individuals with NSCLC.

KRAS Testing

Analysis of tumor tissue for somatic variants of the KRAS gene (eg, G12C) may be considered medically necessary to predict treatment response to sotorasib (Lumakras) in individuals with advanced lung adenocarcinoma or in whom an adenocarcinoma component cannot be excluded, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines ).

Analysis of plasma for somatic variants of the KRAS gene (eg, G12C) using an FDA-approved companion diagnostic plasma test to detect ctDNA may be considered medically necessary as an alternative to tissue biopsy (see Policy Guidelines) to predict treatment response to sotorasib (Lumakras) in individuals with advanced lung adenocarcinoma or in whom an adenocarcinoma component cannot be excluded, if the individual does not have any FDA-labeled contraindications to the requested agent and both the agent and ctDNA test are intended to be used consistently with their FDA-approved labels (see Policy Guidelines).

All other uses of analysis of somatic variants of the KRAS gene in tissue or plasma are considered investigational.

RET Rearrangement Testing

Analysis of tumor tissue for somatic alterations in the RET gene may be considered medically necessary to predict treatment response to RET inhibitor therapy (e.g., pralsetinib (Gavreto) or selpercatinib (Retevmo) in individuals with metastatic NSCLC, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines).

Analysis of tumor tissue for somatic alterations in the RET gene is considered investigational in all other situations.

Analysis of plasma for somatic alterations of the RET gene using plasma specimens to detect ctDNA is considered investigational as an alternative to tissue biopsy (see Policy Guidelines) to predict treatment response to RET inhibitor therapy (eg, selpercatinib [Retevmo], pralsetinib [Gavreto]) in individuals with NSCLC.

MET Exon 14 Skipping Alteration

Analysis of tumor tissue for somatic alterations in tissue that leads to MET exon 14 skipping may be considered medically necessary to predict treatment response to capmatinib (Tabrecta) in individuals with metastatic NSCLC, if the individual does not have any FDA-labeled contraindications to the requested agent and the agent is intended to be used consistently with the FDA-approved label (see Policy Guidelines).

Analysis of plasma for somatic alteration that leads to MET exon 14 skipping using an FDA-approved companion diagnostic plasma test to detect ctDNA may be considered medically necessary as an alternative to tissue biopsy (see Policy Guidelines) to predict treatment response to MET inhibitor therapy (eg, capmatinib [Tabrecta]) in individuals with NSCLC, if the individual does not have any FDA-labeled contraindications to the requested agent and both the agent and ctDNA test are intended to be used consistently with their FDA-approved labels (see Policy Guidelines).

All other uses of analysis of somatic variants of the MET gene in tissue or plasma are considered investigational.

Plasma Testing When Tissue is Insufficient

Plasma tests for oncogenic driver variants deemed medically necessary on tissue biopsy may be considered medically necessary to predict treatment response to targeted therapy for individuals meeting the following criteria:

Individual does not have sufficient tissue for standard molecular testing using formalin-fixed paraffin-embedded tissue; AND

Follow-up tissue-based analysis is planned should no driver variant be identified via plasma testing.

Testing for other variants may become available between policy updates.

Cytochrome P450 (CYP450) genotyping for the purpose of aiding in the choice of clopidogrel versus alternative antiplatelet agents, or in decisions on the optimal dosing for clopidogrel, is considered investigational.

CYP2D6 genotyping to determine drug metabolizer status may be considered medically necessary for individuals :

With Gaucher disease being considered for treatment with eliglustat; OR

With Huntington disease being considered for treatment with tetrabenazine in a dosage greater than 50 mg per day

CYP2C9 genotyping to determine drug metabolizer status may be considered medically necessary for individuals:

With relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, being considered for treatment with siponimod.

CYP450 genotyping for the purpose of aiding in the choice of drug or dose to increase efficacy and/or avoid toxicity for the following drugs is considered investigational, aside from determinations in the separate related policies noted above:

selection or dosage of codeine

dosing of efavirenz and other antiretroviral therapies for HIV infection

dosing of immunosuppressants for organ transplantation

selection or dosing of β-blockers (eg, metoprolol)

dosing and management of antitubercular medications.

The use of genetic testing panels that include multiple CYP450 variants is considered investigational.

Genetic testing for a NOTCH3 variant to confirm the diagnosis of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) syndrome in a patient may be considered medically necessary under the following conditions:

Clinical signs, symptoms, and imaging results are consistent with CADASIL, indicating that the pretest probability of CADASIL is at least in the moderate-to-high range (see the Policy Guidelines section); and

The diagnosis of CADASIL is inconclusive following alternative methods of testing, including magnetic resonance imaging.

For individuals who are asymptomatic with a family member with a diagnosis of CADASIL syndrome:

If there is a family member (first- and second-degree relative) with a known variant, targeted genetic testing of the known NOTCH3 familial variant may be considered medically necessary.

If the family member’s genetic status is unknown, genetic testing of NOTCH3 (see Policy Guidelines section) may be considered medically necessary.

Genetic testing for a NOTCH3 variant to confirm the diagnosis of CADASIL syndrome in all other situations is considered investigational.

Testing for BRAF V600 variants in tumor tissue of individuals with unresectable or metastatic melanoma, or with resected stage III melanoma may be considered medically necessary to select individuals for treatment with FDA-approved BRAF inhibitors or MEK inhibitors.

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

Testing for BRAF V600E variants in individuals with glioma may be considered medically necessary to select individuals for targeted treatment with dabrafenib in combination with trametinib.

Testing for BRAF V600 variants for all other individuals with glioma to select targeted treatment is considered investigational.

Genetic testing for inherited thrombophilia, including testing for the factor V Leiden variant, prothrombin gene variants, and variants in the 5,10-methylenetetrahydrofolate reductase (MTHFR) gene, is considered investigational.

Genetic testing for Rett syndrome-associated genes (eg, MECP2, FOXG1, or CDKL5) may be considered medically necessary to establish a genetic diagnosis of Rett syndrome in a child with developmental delay and signs/symptoms of Rett syndrome, when a definitive diagnosis cannot be made without genetic testing.

Targeted genetic testing for a known familial Rett syndrome-associated variant may be considered medically necessary to determine carrier status of first-degree female relatives (a mother or a sister) of an individual with Rett syndrome.

All other indications for genetic testing for Rett syndrome-associated genes (eg, MECP2, FOXG1, or CDKL5), including routine carrier testing (preconception or prenatal) in persons with negative family history, and testing of asymptomatic family members to determine future risk of disease, are considered investigational.

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

Gene expression assays for determining the prognosis of stage II or III colon cancer following surgery are considered investigational.

Circulating tumor DNA assays for determining the prognosis of stage II or III colon cancer following surgery are considered investigational.

Genetic testing for hereditary hearing loss genes (GJB2, GJB6, and other hereditary hearing loss–related genes) in individuals with suspected hearing loss to confirm the diagnosis of hereditary hearing loss (see Policy Guidelines section) may be considered medically necessary.

Preconception genetic testing (carrier testing) for hereditary hearing loss genes (GJB2, GJB6, and other hereditary hearing loss-related genes) in parents may be considered medically necessary when at least one of the following conditions has been met:

Offspring with hereditary hearing loss OR

One or both parents with suspected hereditary hearing loss OR

First- or second-degree relative affected with hereditary hearing loss OR

First-degree relative with offspring who is affected with hereditary hearing loss.

Genetic testing for hereditary hearing loss genes is considered investigational for all other situations, including, but not limited to, testing individuals without hearing loss (except as addressed in related policies, eg, evidence review 4.02.05 [preimplantation genetic testing]).

Chromosomal microarray testing of fetal tissue may be considered medically necessary for the evaluation of pregnancy loss in patients with indications for genetic analysis of the embryo or fetus (see Policy Guidelines).

The use of targeted MCM6 -13910C>T variant analysis for the prediction of lactase insufficiency is considered investigational.

Gene expression testing in the evaluation of patients with stable ischemic heart disease is considered investigational for all indications, including but not limited to prediction of coronary artery disease in stable, nondiabetic patients.

Genetic testing for PTEN may be considered medically necessary to confirm the diagnosis when a patient has clinical signs of a PTEN hamartoma tumor syndrome.

Targeted genetic testing for a PTEN familial variant may be considered medically necessary in a first-degree relative of a proband with a known PTEN pathogenic variant.

Genetic testing for PTEN is considered investigational for all other indications.

The Antigen Leukocyte Antibody Test is considered investigational for all indications.

The use of maternal serum biomarker tests with or without additional algorithmic analysis for prediction of preeclampsia is considered investigational.

The use of maternal serum biomarker tests with or without additional algorithmic analysis for prediction of spontaneous preterm birth is considered investigational.

The use of multicancer early detection (MCED) tests (e.g., Galleri) is considered investigational for cancer screening.

Use of tests utilizing systems pathology that include cellular and biologic features of a tumor is considered investigational, including use in predicting risk of recurrence in patients with prostate cancer.

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.

The following refers to average-risk asymptomatic women aged 21 to 65: Preparation of Papanicolaou (Pap) smears using conventional or a monolayer slide preparation system may be considered medically necessary every 2 to 3 years. Primary screening and rescreening of Pap smears using the FocalPoint™ or ThinPrep® automated slide reading systems may be considered medically necessary. HPV testing, in conjunction with Pap smears, for the purpose of screening women over age 30 for cervical abnormalities may be considered medically necessary. The following refers to high-risk or symptomatic women or those with a prior abnormal Pap: Human papillomavirus (HPV) testing of Pap smears that have an interpretation of atypical squamous cells of undetermined significance (ASCUS) may be considered medically necessary. HPV testing for the purpose of following-up prior positive HPV tests in women over age 30 may be considered medically necessary.

Primary screening and rescreening of Pap smears using the FocalPoint™ system automated slide reading system in high-risk patients is investigational.

La prueba genética para determinar polimorfismo en sistema enzimático citocromo p450 (CYP2C19) no procede para pago cuando se utiliza en el tratamiento de H. pylori.
Estudios hasta el momento no proveen evidencia definitiva que el tratamiento sustentado en técnicas farmacogenómicas mejoren los resultados en la salud.

KRAS, NRAS, BRAF, or HER2 testing 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, NRAS, BRAF, or HER2 testing of tumor tissue to guide colorectal cancer targeted therapy are considered investigational.

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

Genetic testing for predisposition to hypertrophic cardiomyopathy may be considered medically necessary for individuals who are at risk for development of hypertrophic cardiomyopathy, defined as having a first-degree relative with established hypertrophic cardiomyopathy, when there is a known pathogenic gene variant present in that affected relative (see Policy Guidelines section).

Genetic testing for predisposition to hypertrophic cardiomyopathy is considered investigational for individuals with a family history of hypertrophic cardiomyopathy in which a first-degree relative with established hypertrophic cardiomyopathy has tested negative for pathogenic variants.

Genetic testing for predisposition to hypertrophic cardiomyopathy is considered investigational for all other patient populations, including but not limited to individuals who have a first-degree relative with clinical hypertrophic cardiomyopathy, but in whom genetic testing is unavailable.

The use of the Presage ST2 Assay to evaluate the prognosis of individuals diagnosed with chronic heart failure is considered investigational.

The use of the Presage ST2 Assay to guide management (eg, pharmacologic, device-based, exercise) of individuals diagnosed with chronic heart failure is considered investigational.

The use of the Presage ST2 Assay in the post cardiac transplantation period, including but not limited to predicting prognosis and predicting acute cellular rejection, is considered investigational.

The measurement of volatile organic compounds to assist in the detection of moderate grade 2R (formerly grade 3) heart transplant rejection is considered investigational.

The use of peripheral blood measurement of dd-cfDNA in the post cardiac transplantation period, including but not limited to predicting prognosis and predicting acute cellular rejection, is considered investigational.

The use of peripheral blood gene expression profile tests alone or in combination with peripheral blood measurement of donor-derived cell-free DNA (dd-cfDNA) in the management of individuals after heart transplantation, including but not limited to the detection of acute heart transplant rejection or heart transplant graft dysfunction, is considered investigational.

The use of peripheral blood measurement of dd-cfDNA in the management of individuals after renal transplantation, including but not limited to the detection of acute renal transplant rejection or renal transplant graft dysfunction, is considered investigational.

The use of peripheral blood measurement of dd-cfDNA in the management of individuals after lung transplantation, including but not limited to the detection of acute lung transplant rejection or lung transplant graft dysfunction, is considered investigational.

HIV tropism testing (see Policy Guidelines section for testing methods) may be considered medically necessary for selecting patients for treatment with HIV coreceptor antagonists, such as maraviroc, when there is an immediate plan to prescribe a coreceptor antagonist.

HIV tropism testing without immediate plans to prescribe HIV coreceptor antagonists such as maraviroc is not medically necessary.

Repeat HIV tropism testing during coreceptor antagonist treatment or after failure with coreceptor antagonists is investigational.

HIV tropism testing to predict disease progression (irrespective of coreceptor antagonist treatment) is investigational.

The use of procalcitonin in the clinical setting is not considered for payment. Clinical studies published are not consistent in their value. A metaanalysis published in Lancet Infec Dis in 2007 concludes that procalcitonin cannot reliably differentiate sepsis from other causes of the systemic inflammatory response in critically ill adult patients. This study does not favor the widespread use of this test in the critical care setting. More studies are needed in the evaluation of the severity of infection, the prognosis of the disease and the response to therapeutic measures.

Measurement of long-chain omega-3 fatty acids in red blood cell membranes, including but not limited to its use as a cardiac risk factor, is considered investigational.

Detection and quantification of circulating tumor cells is considered investigational in the management of patients with cancer.

In the outpatient setting rapid flu tests may be considered medically necessary as a technique to guide decisions about diagnosis and treatment of patients suspected of being infected with Influenza A or B. Note: This policy does not consider rapid flu tests as part of community surveillance programs to determine the prevalence of influenza.

Identificación de genotipo o fenotipo se considera para pago en pacientes que no han respondido a terapia antiviral o que la reducción de carga viral ha sido subóptima.
Identificación de genotipo o fenotipo se considera para pago en pacientes con una infección aguda o reciente para planificar tratamiento.
Identificación de genotipo o fenotipo se considera para pago en pacientes que nunca han sido tratados con medicamentos antivirales (“treatment naive”) y comienzan en tratamiento.
El uso rutinario de identificación de genotipo y fenotipo en combinación no procede para pago.
El comparar el fenotipo/genotipo de un paciente con un banco de data de genotipos/fenotipos conocido con el propósito de predecir susceptibilidad a un medicamento se considera investigacional y no procede para pago.

El uso de la prueba de fibronectina fetal (fFN), se considera para pago en mujeres con embarazos sencillos o gemelos, membranas intactas y con una dilatación cervical de menos de 3cms y quienes experimenten síntomas que sugieran un parto pretérmino. Esta prueba debe usarse para determinar la necesidad de hospitalización.

No se considerará para pago en las siguientes situaciones:

Como parte del tratamiento de rutina en mujeres sintomáticas que no tengan factores de riesgo para parto prematuro y sin síntomas de parto prematuro.

Como parte del monitoreo en mujeres sintomáticas pero en riesgo de parto prematuro, tales como: embarazos múltiples, historial de parto prematuro anterior, anomalía uterina, incompetencia cervical o historial de dos o más abortos espontáneos en el segundo trimestre.

Como parte del monitoreo de embarazos de triples o más, membranas intactas y con síntomas que sugieran parto prematuro.

Como una forma de identificar pacientes a término, las cuales se considerarán para inducción del parto o aquellas en las que se espera un probable parto en 24 a 48 horas y no requieren inducción.

Cerebrospinal fluid biomarker testing, including but not limited to amyloid beta peptides, tau protein, or neural thread proteins, as an adjunct to clinical diagnosis in individuals with mild cognitive impairment is considered investigational.

Cerebrospinal fluid biomarker testing, including but not limited to amyloid beta peptides, tau protein, or neural thread proteins, as an adjunct to clinical diagnosis in individuals with mild dementia due to Alzheimer disease is considered investigational.

Cerebrospinal fluid biomarker testing, including but not limited to amyloid beta peptides, tau protein, or neural thread proteins, as part of an evaluation for the initiation of amyloid beta targeting therapy in individuals with mild cognitive impairment or mild dementia due to Alzheimer disease is considered investigational.

Cerebrospinal fluid biomarker testing, including but not limited to amyloid beta peptides, tau protein, or neural thread proteins, as part of an evaluation for the continuation of amyloid beta targeting therapy in individuals with mild cognitive impairment or mild dementia due to Alzheimer disease is considered investigational.

Measurement of urinary and blood biomarkers as an adjunct to clinical diagnosis in individuals with mild cognitive impairment or mild dementia due to Alzheimer disease is considered investigational.

In outpatient pain management, presumptive (i.e. immunoassay) drug testing may be considered medically necessary for:

Baseline screening before initiating treatment or at the time treatment is initiated, when the following conditions are met:

An adequate clinical assessment of patient history and risk of substance use disorder is performed;

Clinicians have knowledge of test interpretation;

There is a plan in place regarding how to use test findings clinically;

Drug testing is ordered by a clinician during an office visit.

Subsequent monitoring of treatment at a frequency appropriate for the risk level of the individual patient (see Policy Guidelines section).

In outpatient substance use disorder treatment, laboratory, in-office or point-of-care presumptive (i.e. immunoassay) drug testing may be considered medically necessary under the following conditions:

Baseline screening before initiating treatment or at the time treatment is initiated (i.e. induction phase), 1 time per program entry, when the following conditions are met:

An adequate clinical assessment of patient history and risk of substance use disorder is performed;

Clinicians have knowledge of test interpretation;

There is a plan in place regarding how to use test findings clinically;

Drug testing is ordered by a clinician during an office visit.

Stabilization and Maintenance phase –

Using an appropriate test, matrix, and frequency of testing for the risk level of the individual and the substance being used (see Policy Guidelines section)

Documentation in the medical record explains the following (see Policy Guidelines section):

Rationale for the specific test(s) ordered,

Patient’s history of substance use,

How drug testing results will guide medical decision-making.

Definitive (i.e. confirmatory) drug testing, in outpatient pain management or substance use disorder treatment, may be considered medically necessary under the following circumstances:

When immunoassays for the relevant drug(s) are not commercially available

In specific situations for which definitive drug levels are required for clinical decision making (see Policy Guidelines section).

In outpatient pain management and outpatient substance use disorder treatment, drug testing is considered investigational when the above criteria are not met including but not limited to routine presumptive or definitive drug testing or standing orders (eg, testing at every visit, without consideration for specific patient risk factors or without consideration for whether definitive testing is required for clinical decision making) and validity testing when used as a separate evaluation (see Policy Guidelines).

Drug testing in the following settings may be considered medically necessary:

Emergency rooms

Ambulatory surgery

Inpatient services

An abrupt change in mental status (to rule out substance intoxication or delirium)

Drug or alcohol exposure during pregnancy

To rule out a fetal withdrawal syndrome by testing the mother for drug use.

The assessment of human epidermal growth factor receptor 2 (HER2) status by quantitative total HER2 protein expression and HER2 homodimer measurement is considered investigational.

Measurement of lipoprotein-associated phospholipase A2 is considered investigational.

Measurement of anti-CCP may be considered medically necessary when used as part of the diagnostic workup for rheumatoid arthritis. Measurement of anti-CCP is considered investigational when used to monitor disease activity and/or treatment response.

Determinaciones de marcadores de tumor CA72-4, CA19-9 y CA27.29 no se consideran para pago como una técnica para diagnosticar, determinar prognosis o respuesta a terapia en tumores de mama o gastrointestinales. Gastrointestinal incluye gástrico, pancreático y colorectal. Las evaluaciones hechas a los marcadores presentaron las siguientes conclusiones:

La evidencia no favorece el uso de estos marcadores en diagnóstico de cáncer de mama primario particularmente en etapas temprana, ya que su sensibilidad es baja.

Ninguno de los marcadores de tumores es específico para cáncer de mama por lo cual su utilidad es muy limitada.

Su utilidad es muy limitada en el diagnóstico diferencial de cáncer metastático de un tumor primario.

No hay evidencia sobre su utilidad como un predictor independiente del pronóstico.

Otros marcadores de tumor descrito en el código 86316 (Inmmunoassay for tumor antigen) no se considera para pago. Estos incluyen pero no se limitan a:

Lipid Associated Sialic Acid (LASA)

In vitro chemoresistance assays, including, but not limited to, Extreme Drug Resistance assay, are considered investigational.

In vitro chemosensitivity assays, including, but not limited to, the Histoculture Drug Response Assay (HDRA), a fluorescent cytoprint assay, or the ChemoFX assay, are considered investigational.

Urea breath testing or fecal antigen testing may be considered medically necessary as part of the workup of patients with dyspeptic symptoms and suspected H. pylori.

Urea breath testing or fecal antigen testing may be considered medically necessary as part of the follow-up of patients with persistent symptoms after treatment for H. pylori infection.

1. Serologic testing for H. pylori may be considered medically necessary as part of the initial workup of a patient with newly diagnosed dyspepsia to guide appropriate empiric therapy.

2. The urea breath test or fecal antigen test may be considered investigational as part of the initial workup of a patient with newly diagnosed dyspepsia to guide appropriate empiric therapy; serologic testing is sufficient.

3. The urea breath test or fecal antigen test may be considered medically necessary as part of the initial workup in patients with a prior history of treated H. pylori infection and with recurrent symptoms.

4. The urea breath test or fecal antigen testing may be considered medically necessary as a follow-up test to determine H. pylori eradication in patients with peptic ulcer and either:

Persistent symptoms after an initial course of anti-H. pylori therapy; or
High-risk factors for ulcer recurrence, such as documented peptic ulcers complicated by bleeding, perforation, or obstruction.

Other indications of when the urea breath test or fecal antigen test may be considered investigational include but are not limited to:

As a routine follow-up test to determine H. pylori eradication in patients with peptic ulcer but without persistent symptoms or high-risk factors for recurrence:

As part of the initial workup of patients with dyspepsia and at increased risk for gastric malignancy; i.e., patients over the age of 50 and those with the “alarm” symptoms of anorexia, early satiety, weight loss, anemia, or gastrointestinal bleeding; these patients are candidates for immediate endoscopy.

The use of nucleic acid testing using a direct or amplified probe technique (without quantification of viral load) may be considered medically necessary for the following microorganisms (see Policy Guidelines):

Bartonella henselae or quintana

Bordetella pertussis

Candida species

Chlamydia pneumoniae

Chlamydia trachomatis

Clostridium difficile

Enterococcus, vancomycin-resistant (eg, enterococcus vanA, vanB)

Enterovirus

Herpes simplex virus

Human papillomavirus

Influenza virus

Legionella pneumophila

Mumps

Mycobacterium species

Mycobacterium tuberculosis

Mycobacterium avium-intracellulare

Mycoplasma pneumoniae

Neisseria gonorrhoeae

Rubeola (measles)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Staphylococcus aureus

Staphylococcus aureus, methicillin-resistant

Streptococcus, group A

Streptococcus, group B

Trichomonas vaginalis

Zika virus.

The use of nucleic acid testing using a direct or amplified probe technique (with or without quantification of viral load) may be considered medically necessary for the following microorganisms:

Cytomegalovirus

Hepatitis B virus

Hepatitis C virus

HIV 1

HIV-2

Human herpesvirus 6.

The use of nucleic acid testing with quantification of viral load is considered investigational for microorganisms that are not included in the list of microorganisms for which probes with or without quantification are considered medically necessary.

The use of nucleic acid testing using a direct or amplified probe technique is considered investigational for the following microorganisms:

Gardnerella vaginalis

Hepatitis G.

The use of the following nucleic acid testing panel (without quantification of viral load) may be considered medically necessary:

Respiratory virus panel.

The use of the following nucleic acid testing panels (with or without quantification of viral load for viral panel elements) is considered investigational:

Central nervous system pathogen panel

Gastrointestinal pathogen panel.

Los anticuerpos anti-neutrófilo citoplásmico y anticuerpo Saccharomyces cerevisiae no se consideran para pago, ya que la baja sensibilidad indica que las pruebas negativas no son clínicamente aceptables.

A single FibroSURE multianalyte assay may be considered medically necessary for the evaluation of patients with chronic liver disease.

FibroSURE multianalyte assays are considered investigational for monitoring of patients with chronic liver disease.

Other multianalyte assays with algorithmic analyses are considered investigational for the evaluation or monitoring of patients with chronic liver disease.

Transient elastography (FibroScan) imaging may be considered medically necessary for the evaluation of patients with chronic liver disease.

Transient elastography (FibroScan) imaging is considered investigational for monitoring of patients with chronic liver disease.

The use of other noninvasive imaging, including but not limited to magnetic resonance elastography, multiparametric magnetic resonance imaging, acoustic radiation force impulse imaging (eg, Acuson S2000), or real-time tissue elastography, is considered investigational for the evaluation or monitoring of patients with chronic liver disease.

El alfa-fetoproteína para detección de cáncer hepatocelular no se considera para pago.

JAK2 testing may be considered medically necessary in the diagnosis of individuals 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 and the International Consensus Classification for diagnosis of PV, 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 individuals 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 (MPNs)

Molecular phenotyping of individuals with MPNs

Monitoring, management, or selecting treatment in individuals with MPNs.

Cardiovascular disease risk panels, consisting of multiple individual biomarkers intended to assess cardiac risk (other than simple lipid panels, see Policy Guidelines section), are considered investigational.

Serum biomarker tests for multiple sclerosis are considered investigational in all situations.

Genetic testing for pain management is considered investigational for all indications (see Policy Guidelines section).

La determinación serológica de anticuerpos (HLA-DQ2 Y HLA-DQ8) de antigliandina y de anticuerpo antiendomisial y la transglutaminosa tisular se considera para pago en los pacientes con síntomas y signos que sugieren enfermedad celiaca. Específicamente en:
Pacientes con serología discordante o resultados histológicos (biopsia) discordantes o

Pacientes con síntomas persistentes a pesar serología y la histología negativa.

Se facturan con los modificadores correspondientes.

Procedimientos que se realizan en lugares de servicio ambulatorios. El participante debe solicitar autorización previa para todo código de procedimiento que se paga en oficina y considere necesario realizarse en una facilidad ambulatoria u hospital. Estos están identificados en carta circular bajo el asunto CÓDIGOS DE PROCEDIMIENTOS QUIRÚRGICOS EXCLUIDOS PARA ADMISIÓN EN HOSPITAL Y CENTROS DE CIRUGÍA AMBULATORIA.

Se requiere que el médico que realice el procedimiento asigne el código CPT que mejor describa el servicio ofrecido. De no existir código se utilizara un código “unlisted” según especificado en la sección correspondiente del CPT. En este caso la facturación del código “unlisted” debe venir acompañada del reporte operatorio legible y hoja de anestesia (según aplique).
La factura de este servicio debe venir acompañada de reporte operatorio legible y hoja de anestesia (según aplique). El uso del modificador 74 es necesario para el pago de estos servicios.

Un procedimiento independiente se considera para pago cuando:
Es el único código facturado.

No se relaciona al área anatómica o al otro servicio que se está realizando en esa sesión.

No es uno de los componentes de un procedimiento mayor.

Limitación
Según establecidas por el CPT y CCI.

La utilización de códigos U se descontinuó en cumplimiento de las directrices de HIPAA. Para identificar procedimientos que no tienen códigos, se usara los códigos de “unlisted procedure” que aparecen al final de cada sección del manual de CPT.

En los casos arriba descritos se envía un informe completo del procedimiento, mecanografiado o en letra de bloque (molde), reporte operatorio, informe de patología, hoja de anestesia y nota de progreso post-operatorio.

Este concepto de códigos con asterisco se aplica a los procedimientos identificados en el Manual de Pago del Participante.

Transportación terrestre de emergencias médicas, son servicios que se considera para pago cuando se cumplen los siguientes criterios:
El transporte médico debe cumplir con todas las leyes federales, estatales y locales. Deben cumplir con todas las licencias y permisos.

La ambulancia o cualquier otro método de transporte médico debe tener todo el equipo y suplidos necesarios para el cuidado del paciente.

La condición del paciente debe ser tal que cualquier otra forma de transportación estaría médicamente contraindicado.

El servicio del cuidado médico podrá ser facturado cuando se provee en ambulancia terrestre para pacientes neonatos o pediátricos con:
Trauma multisistémico
Emergencias ortopédicas complejas o riesgo de pérdida de extremidades.
Condiciones cardiovasculares severas en pacientes con inestabilidad cardiorespiratoria.
Defectos congénitos que requieren cirugía.
Necesidad de tratamiento en cámara hiperbárica de emergencia.
Necesidad de cuidado supraterciario para estabilización.
Quemaduras para unidad de quemados
Emergencia que requiere cirugía neurológica, cardiovascular, urológica o gastrointestinal.
Estado de coma.
Necesidad de intervenciones diagnósticas invasivas por enfermedad o trauma cardiotorácico.
Paciente críticamente enfermo que requiere de trasplante de órganos.
Paciente inestable con traqueotomía y ventilación asistida.
El paciente deberá ser transportado al hospital más cercano que tenga las facilidades adecuadas para el tratamiento de las siguientes condiciones: trauma del paciente y en caso de trasplante de órganos, a la facilidad de trasplante aprobada.
De existir cualquier otra condición no mencionada en el listado anterior, la misma debe estar debidamente documentada y justificada.
En circunstancias excepcionales, las ambulancias marinas ó aéreas pueden ser necesarias. En estas circunstancias todos los criterios que se aplican a la transportación terrestre también se aplican y en adición deben cumplir con los siguientes criterios:
La condición médica del paciente requiere atención inmediata y que esa rapidez no se puede proveer con ambulancia terrestre.

El punto de recogido es inaccesible por ambulancia terrestre.

Las distancias largas, con tiempo limitado son obstáculos a que el paciente reciba el tratamiento adecuado en la facilidad apropiada.

La condición del paciente es tal que la transportación terrestre pone en riesgo su seguridad y/o salud.

El servicio profesional está incluido en la tarifa global de la ambulancia aérea, según especificado en el contrato.

La transportación médica cumple con todas las leyes federales y estatales y tiene todos los permisos y licencias necesarias.

El paciente que está admitido en un hospital agudo y los servicios especializados necesarios no están disponibles en ese hospital.

La facilidad que provee los servicios especializados necesarios para el paciente, es la más cercana y cumple con todas las posibilidades de tratamiento.

Se debe cumplir con todo lo descrito en EMTALA (Emergency Medical Treatment and Activie Labor Act).

Es necesario documentar la razón del traslado. La misma debe ser cónsona con la política de pago. El cuidado cara a cara comienza cuando el médico asume la responsabilidad primaria del paciente pediátrico o adulto en la facilidad/hospital que refiere y termina cuando la facilidad/ hospital que recibe acepta la responsabilidad del cuidado del paciente. Debe ser facturado, solo el tiempo que durante el transporte, el médico esté en contacto directo cara a cara con el paciente.
Los siguientes servicios están incluidos cuando se realizan durante el transporte del paciente:
Evaluaciones de monitoreo rutinarias (Ej. Pulso, respiraciones, presión sanguínea)

Interpretación de las medidas del gasto cardiaco (93561, 93562)

Oximetría de pulso (94760)

Gases arteriales e información almacenada en computadora (Ej. ECG, presión sanguínea, datos hematológicos (99090)).

Entubación gástrica (43752).

Marcapasos transcutáneo temporero (92953)

Manejo de ventilación (94002, 94660, 94662)

Procedimiento de acceso venoso (36000, 36400, 36405, 36406, 36410, 36415, 36591, 36600).

Servicios de ambulancia no se consideran para pago si el paciente fue pronunciado legalmente muerto antes de que se solicite el servicio de la ambulancia.
Los servicios de ambulancia se consideran para pago si el paciente muere después de llamada la ambulancia, antes del recogido o en ruta al hospital de destino.

Triple-S covers for payment all medically necessary and routine services provided in a clinical trial (Clinical Trial) in a manner, manner and according to the terms, limitations and restrictions of the policy to any other insured in the regular plan

Numerous states have enacted laws regarding coverage of health care services delivered through telemedicine for either private insurers, the state Medicaid plan, or both. States have defined «telemedicine» generally as the delivery of health care services such as diagnosis, consultation, or treatment through the use of interactive audio, video, or other electronic media and do not include the sole use of an audio-only telephone, a video-only system, a facsimile machine, instant messages, or electronic mail. Communication consisting of emails, sole telephone conversations and facsimile transmission do not constitute as telemedicine consultation services.  Correct codes for place of services (2) must be used. Prior contracting must have been negotiated with provider.

To be eligible for coverage of related supplies and accessories, and blood glucose monitors, the Member must comply with all the following basic criteria (1) – (4):

The patient has diabetes (See policy ICD-10 codes section) which is being treated by an endocrinologist or pediatric Endocrinologist and are 21 years old or younger; and
Glucose monitor and accessories and related supplies have been ordered by the endocrinologist or pediatric endocrinologist treating diabetes patient and the attending physician maintains records reflecting attention provided including, but not limited to, evidence that the prescribed frequency of testing is according to the patient’s condition
The patient (or the caregiver of a patient) can use the test results to ensure appropriate patient’s glycemic control. And.
The appliance is designed for household use.

If an E2100 or E2101 glucose monitor is supplied and not met the basic criteria of coverage (1) – (5), the items will be denied as not reasonable and necessary

Monitors of glucose in the blood with special features (E2100, E2101) are covered when the basic criteria of coverage (1) – (4) above and the treating physician certifies that the patient has a severe visual impairment (i.e., (best corrected visual acuity of 20/200 or worse in both eyes).

They are also covered for those patients with impaired manual dexterity when the attending physician certifies that the patient has impaired manual dexterity severe enough to require the use of the system of special monitoring.

The standard models of (E0607) home glucose monitors, defined as those that include downloadable memory functions, are covered for all patients diagnosed with diabetes type I, 21 years or less, and in compliance with the the FDA specifications.

Special guidelines for reimbursement for home and supplies glucose monitor.

Triple-S will recognize for payment the services provided by Doctors in Naturopathy, licensed in Puerto Rico. These services are those stipulated in Law 211-1997 of December 30, 1997, namely:  The people licensed in Naturopathic Medicine will be able to:

a. Educate or guide on the different aspects and modalities of neuropathy, techniques, lifestyles and natural therapies that are in harmony with this practice.

b. Interact and participate with doctors and other health professionals in the interdisciplinary    management of the patient’s health, if so requested, and the institution and the professional or health professionals authorize it.

c. Prescribe or recommend natural or integral feeding and other natural products, non-toxic, that do not require medical prescription.

d. Practice the following therapeutic methods:

1. Aromatherapy – therapy based on the use of medicinal and aromatic plants.

2. Balneotherapy (steam thermal water, hydrotherapy) – includes the variety of therapeutic baths executed with water. It also refers to air, sun and other baths.

3. Chromotherapy – refers to the use of color in therapeutic form.

4. Digitopuncture or acupressure – a technique that uses the pressure of the fingers on points in meridians that you wish to stimulate.

5. Fitoterapy (medicinal plants, syrups, poultices, compresses) – is defined as herbology.

6. Homeopathy – refers to the treatment system based on the use of natural substances highly diluted and energized. Doses greater than 20x will not be able to be recommended unless the professional insurance cover covers it.

7. Kinesiology (energy touch) – technique to achieve muscle balance for therapeutic   purposes in which no type of substance or artifact is used since the body’s own energy is used.

8. Douches and showers – refers to the use of enemas, colonics, douching for therapeutic purposes to restore system homeostasis and / or detoxify. These should not be administered by the Naturopath, nor in his office. They must be administered by the person himself.

9. Therapeutic massage – refers to the use of massage for therapeutic purposes.

10. Music therapy – refers to the use of music for therapeutic purposes.

11. Reflexology – refers to therapy similar to «acupressure or acupressure», limited to the area of the feet and hands, which states that any body organ can be stimulated from that area.

12. Biomagnetism – refers to the use of magnets for the treatment of diseases.

e. The naturopath may use assessment methods of naturopathy.

Therapeutic or practical methods of therapeutic massage and music therapy are not intended to limit their use exclusively to naturopaths.

In the same way licensed naturopaths to practice naturopathy will not be able to:

a.Practice, claim or claim that he/she  practices medicine, and / or claim and / or advertise in any way as being a doctor.

b. Prescribe, dispense or administer drugs and / or drugs that require a prescription.

c. Sort, induce or suggest any patient to discontinue treatment prescribed by any doctor.

d. Perform surgical procedures or any other invasive treatment.

d. Perform, refer, interpret or order laboratory tests.

f. Address medical emergencies in your office that require specialized equipment and personnel. However, he/she can attend an emergency, if he/she have and is up to date, in courses or first aid training or paramedical sciences and do not require specialized equipment and personnel.

g. He/she cannot sell or distribute naturopathic products in your own service office.

h. Perform physical examinations or that require undressing the patient to discover, palpate or manipulate their genitals and / or breasts and / or anal or rectal area.

i. Use body fluids or exudates from the body, or any other liquid or substance excreted by the organs of excretion of the human body or animals for consumption, drink or application for therapeutic purposes.

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

Acupuncture may be considered medically necessary for treatment of the following conditions:

1. Chronic neck pain

2. Chronic headache

3. Low back pain

4. Pain from osteoarthritis of the knee or hip (adjunctive therapy)

5.  Post-operative dental pain

6. Temporomandibular disorders (TMD).

7.  Post-operative and chemotherapy-induced nausea and vomiting

8.  Nausea of pregnancy

Acupuncture for any other indication, including but not limited to acupuncture for the treatment of pain, is considered investigational.

Triple-S cubrirá las pruebas de audiología ambulatoria en niños y adultos cuando éstas sean requeridas y supervisadas por un otorrinolaringólogo.
El Programa de Cernimiento Auditivo Neonatal establece realizar pruebas de intervención temprana en todo infante antes de abandonar la sala de recién nacidos del hospital. Por tal motivo Triple-S reconocerá para pago este servicio, fuera del per diem contratado, para procedimientos con fecha de servicio a partir del 19 de enero 2004. (Carta circular M0401001)

El trabajador social clínico podrá facturar a Triple-S por servicios autorizados por Ley por manejo clínico (diagnóstico y tratamiento) de enfermedades mentales.
Podrá facturar directamente al plan si son servicios ambulatorios ofrecidos como integrante de un equipo multidisciplinario de salud mental o bajo la supervisión del médico siquiatra.

En el caso de una facilidad de cuido de salud mental, ésta podrá facturar por el servicio del trabajador social clínico previo acuerdo mutuo.

En pacientes hospitalizados éstos servicios están incluidos en el “perdiem”.

Los servicios ofrecidos por este profesional serán facturados según tarifa establecida por Triple-S.

El trabajador social clínico no facturara por el servicio de consulta hecho a otros profesionales de la salud.

The doctor in osteopathy is authorized to practice osteopathy by the Medical Licensing and Discipline Board of the Commonwealth of Puerto Rico. It grants its license to practice osteopathy in accordance with the provisions of the Law and its regulations. Their services will be covered as stipulated by Triple-S.

Se consideran para pago los servicios por optómetras para aquellas pólizas que así lo estipulen. Estos servicios no se limitarán a examinar los ojos, realizar refracciones y la prescripción de espejuelos.
Será requisito para el participante poseer la licencia estatal para la práctica de la optometría.

Triple-S considera para pago servicios ambulatorios e intrahospitalarios, diagnósticos y terapéuticos, que los sicólogos clínicos puedan proveer bajo la Ley estatal.
Política de Pago:
Las entrevistas y terapias se consideran a base de una tarifa establecida por Triple-S.

Los servicios terapéuticos incluyen la evaluación, diagnóstico y tratamiento de disfunciones emocionales, mentales, modificación de la conducta, consejería matrimonial, educativa, vocacional y resolución de conflictos.

Pruebas diagnósticas se consideran para pago según las tarifas establecidas por Triple-S.

Estos servicios deben de estar debidamente documentados para propósitos de auditorías posteriores.

Chiropractic services may be considered medically necessary when all of the following criteria are met:

The member has a neuromusculoskeletal disorder; and
The medical necessity for treatment is clearly documented; and
Improvement is documented within the initial 4 weeks of chiropractic care.

Chiropractic manipulations may be considered medically necessary for individuals of 0-4 years old when all of the following criteria are met:

The member has a neuromusculoskeletal disorder related to the cervical region; and
The medical necessity for treatment of the cervical region is clearly documented; and
Improvement is documented within the initial 4 weeks of chiropractic care.

Chiropractic manipulations for individuals 0-4 years old with any other conditions is considered investigational.

If no improvement is documented within the initial 4 weeks, additional chiropractic treatment is considered not medically necessary unless the chiropractic treatment is modified.

If no improvement is documented within 30 days despite modification of chiropractic treatment, continued chiropractic treatment is considered not medically necessary.

Once the maximum therapeutic benefit has been achieved, continuing chiropractic care is considered not medically necessary.

Chiropractic manipulation in asymptomatic persons or in persons without an identifiable clinical condition is considered not medically necessary.

The fact that there is a symptom of «pain» is not sufficient to justify medical necessity.  Misalignment of a peripheral joint or vertebral misalignment should be documented by X-rays and/or complete physical examination.

Manipulation is considered experimental or investigational when it is rendered for non-neuromusculoskeletal conditions (e.g., attention-deficit hyperactivity disorder, asthma, autism spectrum disorder, rheumatologic pain, depression, dizziness/vertigo, dysmenorrhea, epilepsy, female infertility, gastro-intestinal disorders, improvement of brain function, and menopause-associated vasomotor symptoms, muscular dystrophy, multiple sclerosis, pneumonia, and pulmonary emphysema; not an all-inclusive list) because its effectiveness for these indications is unproven.

Manipulation of infants is considered experimental and investigational for non-neuromusculoskeletal indications (e.g., infants with gastro-intestinal disorders including constipation, excessive intestinal gas, and gastroesophageal reflux disease).

Preventive manipulation services are not considered for payment, regardless of the age of the patient.

Chronic cases lasting more than 12 weeks and maintenance therapies are not considered for payment.

Only acute cases and exacerbations of chronic cases will be covered. The Acute Treatment (AT) modifier was developed to clearly define the difference between acute treatment and maintenance treatment and is required for reporting Chiropractic Manipulations.

An acute condition is considered when:

is a new complaint, lasting less than 4 weeks, evidenced by the date of X-rays or physical examination and when the interval between its first manipulation and the initial evaluation is relatively short or,
an acute exacerbation of a chronic condition.

It is expected that treatment by the chiropractor produces a substantial improvement in the patient’s condition.

The following conditions are not considered for payment:

•           Acute fractures, dislocations, or old fractures with evidence of instability.

•           Neoplasms that involve the spinal column.

•           Infections in the spine that involve the bones or joints.

•           The presence of an aneurysm near an area for manipulation.

•           Critical conditions

X-rays by chiropractors:

There is an approved policy by Triple-S authorizing the offering of benefits in accordance with the request of Cost-Plus groups or biddings.

The law that regulates the practice of chiropractic in Puerto Rico in its Chapter 7, Paragraph 158 (License-Power Conferred) Letter A indicates the following:

Examine and analyze the human body through the use of physical, chemical, electrical, thermal, or ionic radius methods, as well as through the use of X-rays and other imaging studies as the law dictates.

To bill X-rays services, the chiropractor must have the Radiological Health Certification.

X-ray services are covered as long as they are ordered by a physician surgeon or chiropractor as established in the coverage.

The following services are not considered for payment to chiropractors.

•           Laboratory analysis

•           Injection

•           Medications

•           EKG

•           Acupuncture

•           Nutritional Supplements

•           Orthopedic devices

Intravitreal injection of ranibizumab, bevacizumab, or aflibercept may be considered medically necessary for the treatment of the following retinal vascular conditions:

Diabetic macular edema*
Diabetic retinopathy*
Macular edema following retinal vein occlusion*
Retinopathy of prematurity
Neovascular glaucoma
Rubeosis (neovascularization of the iris)

Intravitreal injection of ranibizumab, bevacizumab, or aflibercept is considered investigational for the treatment of all other retinal vascular disorders. Intravitreal injection of pegaptanib is considered investigational for treatment of retinal vascular disorders, including proliferative diabetic retinopathy, diabetic macular edema, and central or branch retinal vein occlusion. * FDA approved indication (Lucentis and EYLEA)

A fluocinolone acetonide intravitreal implant 0.59 mg (Retisert®) may be considered medically necessary for the treatment of:

Chronic noninfectious intermediate, posterior, or panuveitis

A fluocinolone acetonide intravitreal implant 0.19 mg (Iluvien®) may be considered medically necessary for the treatment of:

Diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

A dexamethasone intravitreal implant 0.7 mg (Ozurdex™) may be considered medically necessary for the treatment of:

Noninfectious ocular inflammation, or uveitis, affecting the intermediate or posterior segment of the eye, OR

Macular edema following branch or central retinal vein occlusion, OR

Diabetic macular edema.

A punctum dexamethasone insert 0.4 mg (Dextenza®) may be considered medically necessary for the treatment of

Ocular inflammation and pain following ophthalmic surgery

A fluocinolone acetonide intravitreal implant 0.59 mg (Retisert®) or 0.19 mg (Iluvien®) or dexamethasone intravitreal implant 0.7 mg (Ozurdex™) is considered investigational for the treatment of

Birdshot retinochoroidopathy,OR

Cystoid macular edema related to retinitis pigmentosa,OR

Idiopathic macular telangiectasia type 1,OR

Postoperative macular edema,OR

Circumscribed choroidal hemangiomas,OR

Proliferative vitreoretinopathy,OR

Radiation retinopathy,OR

Prophylaxis of cystoid macular edema in patients with noninfectious intermediate uveitis or posterior uveitis and cataract undergoing cataract surgery

A fluocinolone acetonide intravitreal implant 0.18 mg (Yutiq®) is considered investigational for the treatment of chronic noninfectious posterior uveitis affecting the posterior segment of the eye

All other uses of a corticosteroid intravitreal implant are considered investigational.

Intraocular placement of a radiation source (brachytherapy) for the treatment of choroidal neovascularization is considered investigational.

Proton beam therapy for the treatment of choroidal neovascularization is considered investigational.

Stereotactic radiotherapy for the treatment of choroidal neovascularization is considered investigational.

Terapia con láser para la destrucción de drusen macular no se considera para pago, ya que no hay evidencia definitiva de sus beneficios y complicaciones. La evidencia conflictiva principal proveyó un estudio donde el ojo tratado mejoró la agudeza visual al cabo de un año, pero el ojo contralateral, no tratado, mostró un aumento en el desarrollo de CNV.

Retinal prostheses are considered investigational.

Contact lenses are considered for payment for any of the following indications:

A. Congenital aphakia

B. Acquired aphakia after cataract surgery (adult or pediatric);

C. Irregular corneas / corneal scarring when vision cannot be corrected with glasses (for example, keratoconus, after corneal graft surgery, after corneal infection);

D. As a corneal dressing to promote wound healing (eg, corneal ulcer / erosion, keratitis);

E. Refractive errors that cannot be corrected at a sharpness level of 20/40 with glasses.

F. Amblyopia when cannot be corrected otherwise.

Contact lenses are not considered for payment for the following conditions:

A. Albinism – as an alternative to polarized glasses to reduce sensitivity to light or severe photophobia;

B. Amblyopia- as an alternative to eye patches therapy / traditional pathing of the eye / occlusion or

C. Prior authorization in the correction of refractive errors instead of glasses, except as indicated above.

Antivascular endothelial growth factor therapies (anti-VEGF), ie, pegaptanib (Macugen®*), ranibizumab (Lucentis™*), bevacizumab (Avastin™), and aflibercept (Eylea™*), may be considered medically necessary as a treatment of neovascular (wet) age-related macular degeneration.

Antivascular endothelial growth factor therapies (anti-VEGF) may be considered medically necessary for the treatment of choroidal neovascularization due to angioid streaks, central serous chorioretinopathy, choroidal rupture or trauma, idiopathic choroidal neovascularization, multifocal choroiditis, pathologic myopia, presumed ocular histoplasmosis syndrome, and uveitis.

Antivascular endothelial growth factor therapies (anti-VEGF) are considered investigational for the treatment of chorioretinal scars.

* FDA-approved indication.

Eyelid thermal pulsation therapy to treat dry eye syndrome is considered investigational.

Insertion of ab externo aqueous shunts approved by the U.S. Food and Drug Administration may be considered medically necessary as a method to reduce intraocular pressure in individuals with glaucoma where medical therapy has failed to adequately control intraocular pressure.

Use of an ab externo aqueous shunt for all other conditions, including in individuals with glaucoma when intraocular pressure is adequately controlled by medications, is considered investigational.

Insertion of ab interno aqueous stents approved by the U.S. Food and Drug Administration as a method to reduce intraocular pressure in individuals with glaucoma where medical therapy has failed to adequately control intraocular pressure is considered medically necessary.

Implantation of 1 or 2 U.S. Food and Drug Administration-approved ab interno stents in conjunction with cataract surgery may be considered medically necessary in individuals with mild-to-moderate open-angle glaucoma treated with ocular hypotensive medication.

Use of ab interno stents for all other conditions is considered investigational.

The Boston (Dohlman-Doane) Keratoprosthesis (Boston KPro) may be considered medically necessary for the surgical treatment of severe corneal opacification in situations where cadaveric corneal transplants have failed or have a very low likelihood of success (see Policy Guidelines).

All other types of permanent keratoprostheses are considered investigational.

A single intravitreal injection of ocriplasmin may be considered medically necessary for treatment of an eye with symptomatic vitreomacular adhesion or vitreomacular traction.

The use of intravitreal ocriplasmin is considered investigational in all other situations, including use of repeat injections of ocriplasmin. .

Analysis of the optic nerve and retinal nerve fiber layer in the diagnosis and evaluation of patients with glaucoma or glaucoma suspects may be considered medically necessary when using scanning laser ophthalmoscopy, scanning laser polarimetry, and optical coherence tomography.

The measurement of ocular blood flow, pulsatile ocular blood flow, or blood flow velocity is considered investigational in the diagnosis and follow-up of patients with glaucoma.

Procedimientos Múltiples: En una sesión operatoria que requiere procedimientos múltiples se pagarán al 100% el procedimiento de mayor valor unitario. (Refiérase a la lista de códigos donde no aplica la regla de procedimientos múltiples).
Procedimientos Bilaterales: Cuando un mismo cirujano lleve a cabo uno o más de un procedimiento bilateral en la misma sesión operatoria se codificarán con una de las siguientes maneras: el modificador 50, indicando 1 (uno) en el campo de unidades. El pago total se calculará como sigue: a base de la tarifa completa del procedimiento de un lado y el 50% del procedimiento del lado contrario.
Si un procedimiento bilateral se factura con otros procedimientos el mismo día, se aplicará el ajuste del procedimiento bilateral antes de aplicar la regla de procedimientos múltiples. El pago total se calculará como sigue: a base de la tarifa completa del procedimiento de un lado y el 50% del procedimiento del lado contrario. Los procedimientos adicionales se calcularán a base del 50% de la tarifa bilateral.
Procedimientos secundarios: se pagarán al 50% de su valor unitario.
Procedimientos incidentales: Procedimientos adicionales que no llenan ninguno de los criterios anteriores, y no se consideran para pago.
Anestesia: En los servicios de anestesia, se aplica el 40% del cálculo establecido en los incisos 1 y 2 de esta sección. También se aplicarán las reglas en incisos 3 y 4.
Limitación
Según establecido en póliza.

Viscocanalostomy is considered investigational.

Canaloplasty may be considered medically necessary as a method to reduce intraocular pressure in individuals with chronic primary open-angle glaucoma under the following conditions:

·         Medical therapy has failed to adequately control intraocular pressure, AND

·         The individual is not a candidate for any other intraocular pressure lowering procedure (eg, trabeculectomy or glaucoma drainage implant) due to a high risk for complications.

Canaloplasty is considered investigational under all other conditions, including angle-closure glaucoma.

Corneal collagen cross-linking using riboflavin and ultraviolet A may be considered medically necessary as a treatment of progressive keratoconus or corneal ectasia resulting from refractive surgery in patients who have failed conservative treatment (eg, spectacle correction, rigid contact lens).

Corneal collagen cross-linking using riboflavin and ultraviolet A is considered investigational for all other indications.

Retinal tele-screening with digital imaging and manual grading of images may be considered medically necessary as a screening technique for the detection of diabetic retinopathy.

Digital retinal imaging with image interpretation by artificial intelligence software that is approved by the U.S. Food and Drug Administration (eg, IDX-DR, EyeArt) may be considered medically necessary for screening for diabetic retinopathy.

Retinal tele-screening is considered investigational for all other indications, including the monitoring and management of disease in individuals diagnosed with diabetic retinopathy.

Office-based vergence/accommodative therapy may be considered medically necessary for individuals with symptomatic convergence insufficiency if, following a minimum of 12 weeks of home-based therapy (eg, push-up exercises using an accommodative target, push-up exercises with additional base-out prisms, jump-to-near convergence exercises, stereogram convergence exercises, recession from a target, and maintaining convergence for 30 to 40 seconds), symptoms have failed to improve.

Orthoptic eye exercises are considered investigational for the treatment of learning disabilities.

Orthoptic eye exercises are investigational for all other conditions, including but not limited to the following:

·         Slow reading

·         Visual disorders other than convergence insufficiency.

A single course of pulmonary rehabilitation in the outpatient ambulatory care setting may be considered medically necessary for the treatment of chronic pulmonary disease for individuals with moderate-to-severe disease who are experiencing disabling symptoms and significantly diminished quality of life despite optimal medical management.

A single course of pulmonary rehabilitation may be considered medically necessary in an outpatient ambulatory care setting as a preoperative conditioning component for those considered appropriate candidates for lung volume reduction surgery (see evidence review 7.01.71) or for lung transplantation (see evidence review 7.03.07).

Pulmonary rehabilitation programs are considered medically necessary following lung transplantation.

Pulmonary rehabilitation programs are considered investigational following other types of lung surgery, including but not limited to lung volume reduction surgery and surgical resection of lung cancer.

Multiple courses of pulmonary rehabilitation are considered investigational, either as maintenance therapy in individuals who initially respond, or in individuals who fail to respond, or whose response to an initial rehabilitation program has diminished over time.

Home-based pulmonary rehabilitation programs are considered investigational.

Pulmonary rehabilitation programs are considered investigational in all other situations.

Cognitive rehabilitation (as a distinct and definable component of the rehabilitation process) may be considered medically necessary in the rehabilitation of patients with cognitive impairment due to traumatic brain injury and autism spectrum disorder.

Cognitive rehabilitation (as a distinct and definable component of the rehabilitation process) is considered investigational for all other applications, including, but not limited to, stroke, postencephalitic or postencephalopathy patients, seizure disorders, multiple sclerosis, the aging population, including patients with Alzheimer disease, patients with cognitive deficits due to brain tumor or previous treatment for cancer, and patients with post-acute cognitive sequelae of SARS-CoV-2 infection.

Sensory integration therapy and auditory integration therapy are considered investigational except for the criteria established in Payment Policy Guidelines for Autistic individual with established dysfunction of sensory processing regarding “BIDA Act,” for the  Autism Spectrum Disorder Population in Puerto Rico; in such case the integration therapy is medically necessary. Professionals with SIT therapies certification may render these services. **