october 2017 policy update bulletin - …...2 oxford® policy update bulletin: october 2017 oxford®...

UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to

support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice

staff with a simple and predictable administrative experience. The Policy Update Bulletin was developed to share important information regarding

Oxford® Medical and Administrative Policy.*

*Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law

I aw

October 2017

policy update bulletin Medical & Administrative Policy Updates

2 Oxford® Policy Update Bulletin: October 2017

Oxford® Medical and Administrative Policy Updates

Overview

Oxford

Tips for using the Policy Update Bulletin:

From the table of contents, click the policy title to be

directed to the corresponding policy update summary.

From the policy updates table, click the policy title to view a

complete copy of a new, updated, or revised policy.

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review

requirements have been adopted for a health service (e.g., test, drug,

device or procedure)

Updated

An existing policy has been reviewed and changes have not been made

to the clinical coverage criteria or documentation review requirements;

however, items such as the clinical evidence, FDA information, and/or

list(s) of applicable codes may have been updated

Revised

An existing policy has been reviewed and revisions have been made to

the clinical coverage criteria and/or documentation review requirements

Replaced

An existing policy has been replaced with a new or different policy

Retired

The health service(s) addressed in the policy are no longer being

managed or are considered to be proven/medically necessary and are

therefore not excluded as unproven/not medically necessary services,

unless coverage guidelines or criteria are otherwise documented in

another policy

Note: The absence of a policy does not automatically indicate or imply

coverage. As always, coverage for a health service must be determined

in accordance with the member’s benefit plan and any applicable

federal or state regulatory requirements. Additionally, UnitedHealthcare

reserves the right to review the clinical evidence supporting the safety

and effectiveness of a medical technology prior to rendering a coverage

determination.

This bulletin provides complete details on Oxford® Clinical,

Administrative and Reimbursement Policy updates. The inclusion of

a health service (e.g., test, drug, device or procedure) in this

bulletin indicates only that UnitedHealthcare has recently adopted a

new policy and/or updated, revised, replaced or retired an existing

policy; it does not imply that Oxford® provides coverage for the

health service. In the event of an inconsistency or conflict between

the information provided in this bulletin and the posted policy, the

provisions of the posted policy will prevail. Note that most benefit

plan documents exclude from benefit coverage health services

identified as investigational or unproven/not medically necessary.

Physicians and other health care professionals may not seek or

collect payment from a member for services not covered by the

applicable benefit plan unless first obtaining the member’s written

consent, acknowledging that the service is not covered by the

benefit plan and that they will be billed directly for the service.

A complete library of Oxford® Medical and

Administrative Policies is available at

OxfordHealth.com > Providers > Tools & Resources >

Medical Information > Medical and Administrative Policies.

https://www.oxhp.com/secure/policy/medical_administrative_policy_index.html

https://www.oxhp.com/secure/policy/medical_administrative_policy_index.html



In This Issue

Oxford

Take Note Page

Implementation of Revised Guidelines for Consultation Services Delayed ................................................................................................................. 7

Clinical Policy Updates

NEW

Carrier Testing for Genetic Diseases - Effective Nov. 1, 2017 ................................................................................................................................. 8 Ilaris® (Canakinumab) - Effective Jan. 1, 2018 ..................................................................................................................................................... 8 Molecular Oncology Testing for Cancer Diagnosis, Prognosis and Treatment Decisions - Effective Nov. 1, 2017 .......................................................... 11 Pharmacogenetic Testing - Effective Nov. 1, 2017 .............................................................................................................................................. 15 Review at Launch for New to Market Medications - Effective Jan. 1, 2018 .............................................................................................................. 15 Whole Exome and Whole Genome Sequencing - Effective Nov. 1, 2017 ................................................................................................................. 16

UPDATED

Core Decompression for Avascular Necrosis - Effective Oct. 1, 2017 ..................................................................................................................... 17 Entyvio® (Vedolizumab) - Effective Nov. 1, 2017 ................................................................................................................................................ 17 Fetal Aneuploidy Testing Using Cell-Free Fetal Nucleic Acids in Maternal Blood - Effective Nov. 1, 2017 ..................................................................... 19 High Frequency Chest Wall Compression Devices - Effective Oct. 1, 2017 .............................................................................................................. 20 Infliximab (Remicade®, Inflectra™, Renflexis™) - Effective Oct. 1, 2017 ................................................................................................................ 20 Lithotripsy for Salivary Stones - Effective Oct. 1, 2017 ........................................................................................................................................ 23 Nerve Graft to Restore Erectile Function During Radical Prostatectomy - Effective Oct. 1, 2017 ................................................................................ 24 Plagiocephaly and Craniosynostosis Treatment - Effective Oct. 1, 2017 ................................................................................................................. 24 Soliris® (Eculizumab) - Effective Nov. 1, 2017 .................................................................................................................................................... 25 Unicondylar Spacer Devices for Treatment of Pain or Disability - Effective Oct. 1, 2017 ........................................................................................... 26

REVISED

Abnormal Uterine Bleeding and Uterine Fibroids - Effective Nov. 1, 2017 ............................................................................................................... 26 Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Nov. 1, 2017 ................................................................................ 28 Drug Coverage Guidelines - Effective Oct. 1, 2017 .............................................................................................................................................. 29

o Renflexis (Infliximab) ................................................................................................................................................................................ 29 Drug Coverage Guidelines - Effective Nov. 1, 2017 ............................................................................................................................................. 29

o Alecensa (Alectinib) ................................................................................................................................................................................... 29 o Cinqair (Reslizumab) ................................................................................................................................................................................. 29 o Daklinza (Daclatasvir) ............................................................................................................................................................................... 29 o Entyvio (Vedolizumab) ............................................................................................................................................................................... 29 o Epclusa (Sofosbuvir/Velpatasfir) ................................................................................................................................................................. 29



In This Issue

Oxford

o Haegarda [C1 Esterase Inhibitor Subcutaneous (Human)] .............................................................................................................................. 29 o Harvoni™ (Ledipasvir/Sofosbuvir) ............................................................................................................................................................... 29 o Humira (Adalimumab) ............................................................................................................................................................................... 29 o Inflectra (Infliximab) ................................................................................................................................................................................. 29 o Incivek (Telaprevir) ................................................................................................................................................................................... 29 o Kalydeco (Ivacaftor) .................................................................................................................................................................................. 29 o Kymriah (Tisagenlecleucel) – [CAR-T (Chimeric Antigen Receptor) Cell Therapy] .............................................................................................. 29 o Mavyret (Glecaprevir and Pibrentasvir) ........................................................................................................................................................ 30 o Minocycline Extended-Release (Generic Solodyn) .......................................................................................................................................... 30 o Nucala (Mepolizumab) ............................................................................................................................................................................... 30 o Olysio (Simeprevir) ................................................................................................................................................................................... 30 o Orencia (Abatacept): SQ Injection ............................................................................................................................................................... 30 o Oxistat (Oxiconazole Nitrate) ...................................................................................................................................................................... 30 o Rebetol (Ribavirin) .................................................................................................................................................................................... 30 o Renflexis (Infliximab) ................................................................................................................................................................................ 30 o Repronex (Menotropins) ............................................................................................................................................................................ 30 o Sensipar (Cinacalcet) ................................................................................................................................................................................ 30 o Soliris (Eculizumab) .................................................................................................................................................................................. 30 o Solodyn (Minocycline HCL) ......................................................................................................................................................................... 30 o Sovaldi (Sofosbuvir) .................................................................................................................................................................................. 30 o Stelara (Ustekinumab): Sub-Cutaneous Injection .......................................................................................................................................... 31 o Stelara (Ustekinumab): Intraveneous Infusion .............................................................................................................................................. 31 o Technivie (Ombitasvir/Paritaprevir/Ritonavir) ............................................................................................................................................... 31 o Triptodur (Triptorelin) ................................................................................................................................................................................ 31 o Tymlos (Abaloparatide) .............................................................................................................................................................................. 31 o Victrelis (Boceprevir) ................................................................................................................................................................................. 31 o Viekira Pak Viekira XR (Ombitasvir, Paritaprevir (ABT-450) and Ritonavir) ....................................................................................................... 31 o Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) ................................................................................................................................................ 31 o Xolair (Omalizumab) ................................................................................................................................................................................. 31 o Xatmep (Methotrexate).............................................................................................................................................................................. 31 o Xeljanz (Tofacitinib) .................................................................................................................................................................................. 31 o Xeljanz XR ............................................................................................................................................................................................... 31 o Xolair (omalizumab) .................................................................................................................................................................................. 31 o Xtandi (Enzalutamide) ............................................................................................................................................................................... 31 o Zepatier (Elbasvir/Grazoprevir) ................................................................................................................................................................... 32 o Zovirax Ointment ...................................................................................................................................................................................... 32

Follicle Stimulating Hormone (FSH) Gonadotropins - Effective Nov. 1, 2017 ........................................................................................................... 32 Gene Expression Tests for Cardiac Indications - Effective Nov. 1, 2017 ................................................................................................................. 36 Genetic Testing for Hereditary Cancer - Effective Nov. 1, 2017 ............................................................................................................................. 37 Gonadotropin Releasing Hormone Analogs - Effective Nov. 1, 2017 ....................................................................................................................... 46



In This Issue

Oxford

Human Menopausal Gonadotropins (hMG) - Effective Nov. 1, 2017 ....................................................................................................................... 50 Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion - Effective Nov. 1, 2017 ......................... 54 Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines - Effective Nov. 1, 2017................................................................. 57 Maximum Dosage Policy - Effective Nov. 1, 2017 ................................................................................................................................................ 60 OcrevusTM (Ocrelizumab) - Effective Nov. 1, 2017 ............................................................................................................................................... 65 Orencia® (Abatacept) Injection for Intravenous Infusion - Effective Nov. 1, 2017 ................................................................................................... 71 Panniculectomy and Body Contouring Procedures - Effective Nov. 1, 2017 ............................................................................................................. 73 Preventive Care Services - Effective Oct. 1, 2017 ............................................................................................................................................... 75 Sodium Hyaluronate - Effective Nov. 1, 2017 ..................................................................................................................................................... 85 Temporomandibular Joint Disorders - Effective Oct. 1, 2017 ................................................................................................................................ 88 Transcatheter Heart Valve Procedures - Effective Nov. 1, 2017 ............................................................................................................................ 89

RETIRED/REPLACED

Genetic Testing - Effective Nov. 1, 2017 ............................................................................................................................................................ 92 Helicobacter Pylori Serology Testing - Effective Oct. 1, 2017 ................................................................................................................................ 92 Magnetoencephalography and Magnetic Source Imaging for Specific Neurological Applications - Effective Oct. 1, 2017 ............................................... 93 Molecular Profiling to Guide Cancer Treatment - Effective Nov. 1, 2017 ................................................................................................................. 93 Wearable Cardioverter-Defibrillators - Effective Oct. 1, 2017 ................................................................................................................................ 93

Administrative Policy Updates

NEW

Follow-Up Care Rendered in an Emergency Room Site of Service - Effective Nov. 1, 2017 ....................................................................................... 94

UPDATED

Claims Recovery - Effective Nov. 1, 2017 .......................................................................................................................................................... 94 Credentialing Guidelines: Participation in the eviCore healthcare Network - Effective Oct. 1, 2017 ............................................................................ 95 Filing Deadlines for Claims Submissions - Effective Nov. 1, 2017 .......................................................................................................................... 96 Precertification Exemptions for Outpatient Services - Effective Oct. 1, 2017 .......................................................................................................... 101

REVISED

Accreditation Requirements for Radiology Services - Effective Nov. 1, 2017 .......................................................................................................... 101

Reimbursement Policy Updates

NEW

Multiple Procedure Payment Reduction (MPPR) for Diagnostic Cardiovascular and Ophthalmology Procedures - Effective Nov. 1, 2017 ......................... 104



In This Issue

Oxford

REVISED

Consultation Services ..................................................................................................................................................................................... 106 Global Days .................................................................................................................................................................................................. 112 Injection and Infusion Services ....................................................................................................................................................................... 113 Maximum Frequency Per Day .......................................................................................................................................................................... 113 Obstetrical Policy - Effective Oct. 1, 2017 ......................................................................................................................................................... 114 Preventive Medicine and Screening .................................................................................................................................................................. 115 Prolonged Services - Effective Nov. 1, 2017 ...................................................................................................................................................... 115 Replacement Codes - Effective Nov. 1, 2017 ..................................................................................................................................................... 118 Supply Policy - Effective Nov. 1, 2017 .............................................................................................................................................................. 119 Urgent Care - Effective Dec. 1, 2017 ................................................................................................................................................................ 122


Take Note

Oxford

IMPLEMENTATION OF REVISED GUIDELINES FOR CONSULTATION SERVICES DELAYED

UnitedHealthcare previously announced that certain revisions to the Consultation Services Reimbursement Policy would become effective for UnitedHealthcare

Commercial members on Oct.1, 2017. As communicated in the October 2017 Network Bulletin, in an effort to give care providers more time to adjust to potential changes in their submission of procedure codes for consultation services, UnitedHealthcare will be delaying implementation of the revisions to the Reimbursement Policy for services reported with consultation codes 99241-99245 and 99251-99255.

The following Oxford® policies have also been impacted by this implementation delay. Please take note of the amended summary of changes for each policy listed below.

Policy Title Policy Type

Consultation Services Reimbursement

Global Days Reimbursement

Injection and Infusion Services Reimbursement

Maximum Frequency Per Day Reimbursement

Obstetrical Policy Reimbursement

Preventive Care Services Clinical

Preventive Medicine and Screening Reimbursement

Temporomandibular Joint Disorders Clinical

https://www.uhcprovider.com/content/dam/provider/docs/public/resources/news/2017/network-bulletin/October-Interactive-Network-Bulletin-2017.pdf



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Policy Title Effective Date Coverage Rationale

NEW

Carrier Testing for Genetic Diseases

Nov. 1, 2017 Genetic counseling is strongly recommended prior to these tests in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person. For information regarding noninvasive prenatal screening (NIPT) for fetal aneuploidy, refer to the medical policy titled Fetal Aneuploidy Testing Using Cell-Free Fetal

Nucleic Acids in Maternal Blood. Ashkenazi Jewish Carrier Screening

Ashkenazi Jewish carrier screening is proven and medically necessary for evaluating the following: Individuals who are seeking prenatal care or planning a pregnancy who have had not previously had informative

Ashkenazi Jewish carrier screening; and At least one of the following additional criteria is met:

o At least one reproductive partner is Ashkenazi Jewish (this individual has at least one Ashkenazi Jewish

grandparent); or o The reproductive partners have a previously affected child with one of the genetic diseases included in the

Ashkenazi Jewish carrier screening test and the results of this test will inform a current or future pregnancy; or

o One or both individuals have a first- or second-degree relative who is affected and the results of this test will inform a current or future pregnancy; or

o One or both individuals have a first-degree relative with an affected offspring and the results of this test will

inform a current or future pregnancy; or o One of the reproductive partners is already known to be a carrier for one of the genetic disease included in

the Ashkenazi Jewish carrier screening test and the results of this test will inform a current or future pregnancy.

Carrier testing for any additional genetic diseases as part of Ashkenazi Jewish carrier screening is considered unproven and not medically necessary.

Ashkenazi Jewish carrier screening is considered unproven and not medically necessary for all other indications. Expanded Carrier Screening Panel Testing

Expanded Carrier Screening Panel Testing is considered unproven and not medically necessary for all indications.

Ilaris® (Canakinumab)

Jan. 1, 2018

Ilaris® (canakinumab) is proven and medically necessary for:

The treatment of Cryopyrin-Associated Periodic Syndromes (CAPS) in patients who meet ALL of the following criteria: For initial therapy, all of the following:

o One of the following, as diagnosed by, or in consultation with, a rheumatologist or immunologist with



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Ilaris® (Canakinumab) (continued)

Jan. 1, 2018

expertise in the diagnosis of the following: Familial Cold Autoinflammatory Syndrome (FCAS) Muckle-Wells syndrome (MWS)

and o Ilaris dosing for FCAS/MWS is in accordance with the United States Food and Drug Administration approved

labeling: maximum dosing of 3mg/kg up to 150 mg every 8 weeks; and

o Initial authorization will be for no more than 12 months. For continuation therapy, all of the following:

o Patient is currently on Ilaris therapy for one of the following: FCAS

MWS and

o Ilaris dosing for FCAS/MWS is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 3mg/kg up to 150 mg every 8 weeks; and

o Documentation of positive clinical response to Ilaris therapy; and o Reauthorization will be for no more than 12 months.

The treatment of Tumor Necrosis Factor (TNF) Receptor-Associated Periodic Syndrome (TRAPS) in

patients who meet ALL of the following criteria: For initial therapy, all of the following:

o Diagnosis of TRAPS by, or in consultation with, a rheumatologist or immunologist with expertise in the diagnosis of TRAPS. and

o Ilaris dosing for TRAPS is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and

o Initial authorization will be for no more than 12 months. For continuation of therapy, all of the following:

o Patient is currently receiving Ilaris therapy for TRAPS; and o Documentation of a positive clinical response to therapy, defined as a decrease in frequency or severity of

attacks; and

o Ilaris dosing for TRAPS is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and

o Reauthorization will be for no more than 12 months. The treatment of Hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in patients who meet ALL of the following criteria:

For initial therapy, all of the following: o One of the following, as diagnosed by, or in consultation with, a rheumatologist or immunologist with

expertise in the diagnosis of the following:



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Jan. 1, 2018

HIDS MKD and

o Ilaris dosing for HIDS/MKD is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and

o Initial authorization will be for no more than 12 months.

For continuation of therapy, all of the following: o Patient is currently receiving Ilaris for one of the following:

HIDS MKD

and o Documentation of a positive clinical response to therapy, defined by a decrease in frequency or severity of

attacks; and o Ilaris dosing for HIDS/MKD is in accordance with the United States Food and Drug Administration approved

labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and o Reauthorization will be for no more than 12 months.

The treatment of Familial Mediterranean Fever (FMF) in patients who meet ALL of the following criteria:

For initial therapy, all of the following: o Diagnosis of FMF by, or in consultation with, a rheumatologist or immunologist with expertise in the

diagnosis of FMF; and o History of failure, contraindication, or intolerance to colchicine; and o Ilaris dosing for FMF is in accordance with the United States Food and Drug Administration approved

labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and o Initial authorization will be for no more than 12 months.

For continuation of therapy, all of the following: o Patient is currently receiving Ilaris for FMF; and o Documentation of a positive clinical response to therapy, defined by a decrease in index disease flare or

normalization of CRP; and

o Ilaris dosing for FMF is in accordance with the United States Food and Drug Administration approved

labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and o Reauthorization will be for no more than 12 months.

The treatment of Systemic Juvenile Idiopathic Arthritis (SJIA) in patients who meet ALL of the following criteria: For initial therapy, all of the following:

o Diagnosis of SJIA by, or in consultation with, a rheumatologist or immunologist with expertise in the diagnosis of SJIA; and

o Ilaris dosing for SJIA is in accordance with the United States Food and Drug Administration approved



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Jan. 1, 2018 labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and o Patient is not receiving Ilaris in combination with another biologic [e.g., Actemra]; and o Initial authorization will be for no more than 12 months.

For continuation of therapy, all of the following: o Patient is currently receiving Ilaris for SJIA; and o Documentation of a positive clinical response to therapy; and

o Ilaris dosing for SJIA is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 4 mg/kg up to 300mg every 4 weeks; and

o Patient is not receiving Iliaris in combination with another biologic [e.g., Actemra]; and o Reauthorization will be for no more than 12 months.

Ilaris is not proven or medically necessary for the management or treatment of cardiovascular disease.

Molecular Oncology Testing for Cancer Diagnosis, Prognosis and Treatment

Decisions

Nov. 1, 2017

Gene Expression Tests for Breast Cancer Treatment

The use of one of the following gene expression tests is considered proven and medically necessary to make a treatment decision regarding adjuvant chemotherapy in females or males with non-metastatic breast cancer when all of the following criteria are met.

However, the use of more than one gene expression test for the same tumor in an individual with breast cancer is unproven and not medically necessary.

Gene Expression Tests for High Risk Breast Cancer

Gene expression tests for high risk breast cancer, including MammaPrint (also referred to as the "Amsterdam Signature" or "70-Gene Signature") are considered proven and medically necessary to assess distant recurrence of disease in individuals with recently diagnosed non-metastatic breast cancer when ALL the following criteria are met: High clinical risk of recurrence based on at least one of the following criteria:

o Lymph node positive (pN1-2); or o Tumor size greater than 2 cm; or

o Poorly differentiated or undifferentiated histology (grade 3) AND tumor size greater than 1 cm; and Hormone receptor-positive (estrogen receptor positive, progesterone receptor positive or both); and HER2 receptor negative; and Adjuvant chemotherapy is not precluded due to any other factor (e.g., advanced age and/or significant co-

morbidities); and Individual and treating physician have had a discussion prior to testing regarding the potential results of the test

and determined to use the results to guide therapy

MammaPrint is considered unproven and not medically necessary for all other indications.



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Molecular Oncology Testing for Cancer Diagnosis,

Prognosis and Treatment Decisions

(continued)

Nov. 1, 2017

Gene Expression Tests for Intermediate and Low Risk Breast Cancer

Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene Signature Assay, EndoPredict and the Breast Cancer Index gene expression tests for intermediate and low risk breast cancer are considered proven and medically necessary to assess use of adjuvant chemotherapy in individuals with recently diagnosed non-metastatic breast cancer when all of the following criteria are met:

Lymph node negative (pN0) or axillary lymph node micrometastasis less than 2mm (pN1mi); and Hormone receptor positive (estrogen receptor positive, progesterone receptor positive or both); and HER2 receptor negative; and Adjuvant chemotherapy is not precluded due to any other factor (e.g., advanced age and/or significant co-

morbidities); and Individual and treating physician have had a discussion prior to testing regarding the potential results of the test

and determined to use the results to guide therapy

Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene Signature Assay, EndoPredict and the Breast Cancer Index are considered unproven and not medically necessary for all other indications. Gene expression profiling assays for breast cancer treatment other than those previously described as

covered are considered unproven and not medically necessary, including but not limited to: BluePrint (also referred to as "80-gene profile")

Breast Cancer Gene Expression Ratio (also known as Theros H/I) BreastNext BreastOncPX BreastPRS Insight DX Breast Cancer Profile Mammostrat

NexCourse Breast IHC4 NuvoSelect eRx 200-Gene Assay Oncotype DX DCIS SYMPHONY Genomic Breast Cancer Profile

TargetPrint TheraPrint The 41-gene signature assay

The 76-gene "Rotterdam signature" assay To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling is useful for managing the treatment of breast cancer and leads to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression profiling as a technique of managing the treatment of breast cancer compared with traditional clinical factors to guide medical management and improve clinical outcomes.



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(continued)

Nov. 1, 2017

Gene Expression Profiling to Identify the Tissue of Origin for Cancers of Unknown Primary Site

To identify the tissue of origin for cancers of unknown primary site, gene expression profiling assays are considered unproven and not medically necessary for all indications, including but not limited to: ResponseDX: Tissue of Origin Test CancerTYPE ID Test

Rosetta Cancer Origin Test (miRview mets and miRview mets2 tests) ProOnc TumorSourceDX Test To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling to identify the tissue of origin for cancers lead to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression profiling to identify the tissue of origin for cancers of unknown primary site compared with traditional clinicopathologic factors to

guide medical management and improve clinical outcomes. Gene Expression Profiling of Melanoma

In cutaneous and uveal melanoma, gene expression profiling assays are considered unproven and not medically necessary for all indications, including but not limited to:

DecisionDx-Melanoma test DecisionDx-UM To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling of

melanoma leads to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression profiling of melanoma compared with traditional clinical factors to guide medical management and improve clinical outcomes. Gene Expression Profiling as a Technique for Colorectal Cancer (CRC) Risk Assessment or Management

In colorectal cancer (CRC) risk assessment or management, gene expression profiling assays are considered unproven and not medically necessary, including but not limited to: Fecal DNA testing, i.e., ColonSentry

Oncotype DX Colon Cancer Assay

Colorectal Cancer DSA GeneFx Colon OncoDefender-CRC To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling as a technique for colorectal cancer (CRC) risk assessment or management lead to improved health outcomes (i.e.,

clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression profiling as a technique for colorectal cancer (CRC) risk assessment or management compared with traditional clinical factors to guide medical management and improve clinical outcomes.



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(continued)

Nov. 1, 2017

Gene Expression Profile Tests for Evaluation or Management of Multiple Myeloma

Gene expression profile tests for evaluation or management of multiple myeloma are considered unproven and not medically necessary, including but not limited to:

MyPRS/MyPRS Plus

To date, the majority of the available studies fail to provide sufficient evidence that gene expression profile tests for

evaluation or management of multiple myeloma lead to improved health outcomes or to manage treatment decisions (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression profile tests for evaluation or management of multiple myeloma compared with traditional clinical

factors to guide medical management and improve clinical outcomes. Gene Expression Profile Tests for the Screening, Detection and Management of Prostate Cancer

Gene-based tests for the screening, detection and management of prostate cancer are considered unproven and not medically necessary, including but not limited to: Oncotype DX Prostate Cancer Assay TMPRSS2 fusion gene Prolaris Prostate Cancer Test Decipher Prostate Cancer Classifier

To date, the majority of the available studies fail to provide sufficient evidence that gene-based tests for the screening, detection and management of prostate cancer lead to improved health outcomes or to manage treatment decisions (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene-based tests for the screening, detection and management of prostate cancer compared with traditional clinical factors to guide medical management and improve clinical outcomes. Topographic Genotyping

Topographic genotyping is unproven and not medically necessary. Examples of such tests include, but

are not limited to, the following: PathFinder TG

To date, the majority of the available studies fail to provide sufficient evidence that topographic genotyping lead to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of topographic genotyping compared with traditional clinical factors to guide medical management and improve clinical outcomes.

Multi-Gene Cancer Panels for Diagnosis, Prognosis and Treatment Decisions (Molecular Profiling)

Molecular profiling of tumors using a multi-gene cancer panel of up to 50 genes is considered proven and medically necessary for patients with metastatic non-small cell lung cancer (NSCLC).



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(continued)

Nov. 1, 2017 Use of more than one gene multi-gene cancer panel for the same individual with non-small cell lung cancer is unproven and not medically necessary.

Multi-gene cancer panels are considered unproven and not medically necessary for all other indications.

Multi-gene cancer panels of greater than 50 genes are considered unproven and not medically necessary

for all indications.

Pharmacogenetic Testing

Nov. 1, 2017 Pharmacogenetic Testing

The use of pharmacogenetic testing panels for genetic polymorphisms is considered unproven and not medically necessary for evaluating drug-metabolizer status.

Examples of these panels include, but are not limited to the following: AIBioTech® CardioloGene Genetic Panel AIBioTech® Pain Management Panel AIBioTech® PsychiaGene Genetic Panel AIBioTech® Urologene Panel AIBioTech® PersonaGene Panel

Genecept™ Assay GeneSight® Analgesic GeneSight® Psychotropic GeneSight® ADHD Millennium PGTSM Proove® Drug Metabolism test panel Proove® Narcotic Risk test panel

SureGene Test for Antipsychotic and Antidepressant Response (STA2R)

Review at Launch for New to Market Medications

Jan. 1, 2018

This Clinical Policy applies to certain newly launched medical benefit medications that are healthcare provider administered, have not yet undergone review by Oxford, and a utilization management strategy has not yet been put in place.

A medication will be subject to review at launch when the medication is listed on the Review at Launch Medication List. A medication subject to review at launch will be: Excluded from coverage until the date the medication is reviewed by Oxford and a utilization management

strategy has been communicated as may be required by law or by December 31 of the following calendar year, whichever is earliest; or

Reviewed against available clinical evidence, which includes applicable Clinical Policies.

Providers are strongly encouraged to seek precertification on any new to market medications that are subject to review at launch to ensure coverage. Please be aware if precertification is not requested, Oxford



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Review at Launch for New to Market Medications

(continued)

Jan. 1, 2018 may later deny the service or item as not medically necessary or not covered. If a provider knows or has reason to believe that a service or item may not be covered, the provider must request precertification from Oxford prior to providing or referring for the service or item. A provider may not collect payment from our commercial members for

services not covered under the applicable benefit plan, unless the member provided written consent before the service was rendered. See Oxford Commercial Supplement to the UnitedHealthcare Provider Administrative Guide for more detail.

Clinical Policies express Oxford’s determination of whether a health services is proven to be effective based on published clinical evidence. They are also used to decide whether a given health service is medically necessary. Services determined to be experimental, investigational, unproven or not medically necessary by the clinical

evidence are typically not covered.

Whole Exome and Whole Genome Sequencing

Nov. 1, 2017

Genetic counseling is strongly recommended prior to these tests in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person. Whole Exome Sequencing (WES)

Whole exome sequencing (WES) is proven and medically necessary for diagnosing or evaluating a genetic disorder when ALL of the following criteria are met:

The patient’s clinical presentation is nonspecific and does not fit a well-defined syndrome for which a specific or targeted gene test is available. If the patient has a suspected specific genetic syndrome, a single gene or targeted gene panel should be performed prior to determining if WES is necessary; and

WES has been recommended by a board-certified medical geneticist , neonatologist, neurologist, or developmental pediatrician with specific expertise in the conditions for which testing is being considered; this specialist physician will act as the ordering provider for WES, and this specialist physician is prepared to interpret any possible test results (including uncertain gene variants and secondary findings unrelated to the initial test indications; and

WES results are expected to directly influence the patient’s medical management recommendations and clinical

outcome and one of the following: o The patient’s clinical presentation or clinical and family history strongly suggest a genetic cause for which a

specific clinical diagnosis cannot be made with any clinically available targeted genetic tests; or

o The patient has a confident clinical diagnosis of a genetic condition where there is significant genetic heterogeneity and WES is a more practical approach to identifying the underlying genetic cause than are individual tests of multiple genes; or

o The patient likely has a genetic disorder and has had multiple targeted gene tests that have failed to identify

the underlying cause. Comparator (e.g., parents or siblings) WES is proven and medically necessary for evaluating a genetic disorder when the above criteria have been met and WES is performed concurrently or has been previously performed on the patient.

https://www.uhcprovider.com/content/dam/provider/docs/public/admin-guides/UnitedHealthcare_Administrative_Guide_2017.pdf



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NEW

Whole Exome and Whole Genome Sequencing

(continued)

Nov. 1, 2017 WES is unproven and not medically necessary for screening and evaluating disorders in individuals when the above criteria are not met. Further studies are needed to evaluate the clinical utility of whole exome sequencing for other indications.

Whole Genome Sequencing (WGS)

Whole genome sequencing (WGS) is unproven and not medically necessary for screening and evaluating any disorder. Although WGS has the potential to identify causal variants for a wide variety of conditions that may be missed with other technologies, as well as to identify predictive biomarkers, the information derived from WGS has not yet been translated into improved patient outcomes and changed patient management. Further studies are needed to establish the clinical utility of WGS.

Policy Title Effective Date Summary of Changes Coverage Rationale

UPDATED

Core Decompression for Avascular Necrosis

Oct. 1, 2017 Updated supporting information to reflect the most current clinical evidence and references;

no change to coverage rationale or lists of applicable codes

Core decompression is proven and medically necessary for treating early (pre-collapse stage I and II) avascular necrosis of the femoral head.

Core decompression is unproven and not medically necessary for treating late avascular necrosis of the femoral head or for avascular

necrosis elsewhere, including the humeral head, the distal femur, the talus or the mandibular condyle. The available evidence for core decompression for these conditions is limited and low quality. Most clinical studies involve a small number of patients and lack proper controls. Therefore, there is insufficient data to allow conclusions regarding the safety and efficacy of core decompression for these indications.

Entyvio®

(Vedolizumab)

Nov. 1, 2017

Updated list of related policies;

added reference link to policy

titled Maximum Dosage Policy

Entyvio (vedolizumab) is proven and medically necessary for the

treatment of:

Crohn's disease when all of the following criteria are met:

For initial therapy, all of the following: o Diagnosis of moderately to severely active Crohn’s disease (CD);

and o One of the following:

History of failure, contraindication, or intolerance to at least one of the following conventional therapies: - Tumor necrosis factor (TNF) blocker [e.g., Humira



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UPDATED

Entyvio® (Vedolizumab) (continued)

Nov. 1, 2017

(adalimumab), Cimzia (certolizumab)] - Immunomodulator (e.g., azathioprine, 6-mercaptopurine) - Corticosteroid

Corticosteroid dependent (e.g., unable to successfully taper corticosteroids without a return of the symptoms of CD)

and

o Entyvio is initiated and titrated according to US Food and Drug Administration (FDA) labeled dosing for Crohn’s disease up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and

o Patient is not receiving Entyvio in combination with either of the following: Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab),

Cimzia (certolizumab)] Tysabri (natalizumab); and

o Initial authorization will be for no more than 14 weeks

For continuation therapy, all of the following:

o Documentation of positive clinical response to Entyvio; and o Entyvio dosing for Crohn’s disease is in accordance with the FDA

labeled dosing up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and

o Reauthorization will be for no more than 12 months Ulcerative colitis when all of the following criteria are met:

For initial therapy, all of the following: o Diagnosis of moderately to severely active ulcerative colitis (UC);

and o One of the following:

History of failure, contraindication, or intolerance to at least one

of the following conventional therapies: - Tumor necrosis factor (TNF) blocker [e.g., Humira

(adalimumab), Simponi (golimumab)] - Immunomodulator (e.g., azathioprine, 6-mercaptopurine)

- Corticosteroid Corticosteroid dependent (e.g., unable to successfully taper

corticosteroids without a return of the symptoms of UC) and

o Entyvio is initiated and titrated according to US Food and Drug Administration labeled dosing for ulcerative colitis up to a maximum



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UPDATED

Entyvio® (Vedolizumab) (continued)

Nov. 1, 2017 of 300mg every 8 weeks (or equivalent dose and interval schedule); and

o Patient is not receiving Entyvio in combination with either of the

following: Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab),

Simponi (golimumab)]

Tysabri (natalizumab); and o Initial authorization will be for no more than 14 weeks

For continuation therapy, all of the following: o Documentation of positive clinical response to Entyvio; and o Entyvio dosing for ulcerative colitis is in accordance with the FDA

labeled dosing up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and

o Reauthorization will be for no more than 12 months

Fetal Aneuploidy

Testing Using Cell-Free Fetal Nucleic

Acids in Maternal Blood

Nov. 1, 2017

Updated list of applicable ICD-10

diagnosis codes: o Added O28.3, O28.9,

O35.0XX0, and O35.2XX0 o Removed O35.0XX9

DNA-based noninvasive prenatal tests of fetal aneuploidy are proven

and medically necessary as screening tools for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) or trisomy 13 (Patau

syndrome) in ANY ONE of the following circumstances: Maternal age of 35 years or older at delivery Fetal ultrasound findings indicating an increased risk of aneuploidy History of a prior pregnancy with a trisomy Positive first- or second-trimester screening test results for aneuploidy

Parental balanced Robertsonian translocation with an increased risk of fetal trisomy 13 or trisomy 21

DNA-based noninvasive prenatal tests of fetal aneuploidy are unproven and not medically necessary for all other indications including, but not limited to, the following:

Multiple gestation pregnancies Screening for microdeletions Screening for sex chromosome aneuploidies

Further studies are needed to evaluate the use of these tests in other

populations. Genetic Counseling

Genetic counseling is strongly recommended prior to this test in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person.



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UPDATED

High Frequency Chest Wall Compression

Devices

Oct. 1, 2017 Updated supporting information to reflect the most current clinical evidence, FDA

information, and references; no change to coverage rationale or lists of applicable codes

High-frequency chest wall compression (HFCWC), as a form of chest physical therapy, is proven and medically necessary when used for treating or preventing pulmonary complications of the following

conditions: Cystic fibrosis (CF) Bronchiectasis

High-frequency chest wall compression (HFCWC), as a form of chest physical therapy, is unproven and not medically necessary for diagnoses other than cystic fibrosis and bronchiectasis, including,

but not limited to respiratory symptoms attributed to neuromuscular disorders when they compromise respiration, such as amyotrophic lateral sclerosis (ALS), cerebral palsy, familial dysautonomia, muscular dystrophy or quadriplegia. The clinical evidence is insufficient to support conclusions regarding the use of HFCWC therapy in these patient populations. Additional research involving

larger study populations and longer treatment and follow-up periods is needed to establish the safety and efficacy of HFCWC for patients with

impaired airway clearance disorders in these patient populations. Note: There are multiple airway clearance techniques currently used in the management of CF and bronchiectasis. These can include percussion and postural drainage, huffing, active cycle breathing and intrapulmonary

percussive ventilation (IPV).

Infliximab (Remicade®, Inflectra™, Renflexis™)

Oct. 1, 2017

Updated list of applicable HCPCS codes to reflect quarterly code edits; added modifier ZC (Merck) to Q5102

This policy refers to the following infliximab products: Inflectra™ (infliximab-dyyb) Remicade® (infliximab) Renflexis™ (infliximab-abda) A. Preferred Product

Remicade® (infliximab) is the preferred infliximab product. Coverage will be provided for Remicade® contingent on the coverage criteria in

section B. Coverage for Inflectra™ (infliximab-dyyb) or Renflexis™ (infliximab-abda) will be provided contingent on the criteria in this section and the coverage criteria in section B. In order to continue coverage, members already on Inflectra™ or Renflexis™ will be required to change therapy to



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UPDATED

Infliximab (Remicade®, Inflectra™,

Renflexis™) (continued)

Oct. 1, 2017

Remicade® unless they meet the criteria in this section.

Preferred Product Criteria

Treatment with Inflectra™ (infliximab-dyyb), Renflexis™ (infliximab-abda) or other infliximab biosimilar is medically necessary for the

indications specified in this policy when the following criteria are met: Both of the following:

o One of the following: Both of the following:

- History of a trial of at least 14 weeks of Remicade resulting in minimal clinical response to therapy and residual disease activity.

- Physician attests that in their clinical opinion the clinical response would be expected to be superior with Inflectra or other infliximab biosimilar product, than experienced with Remicade.

or

Both of the following: - History of intolerance or adverse event to Remicade.

- Physician attests that in their clinical opinion the same intolerance or adverse event would not be expected to occur with Inflectra or other infliximab biosimilar product.

and o Both of the following:

Patient has NOT had a loss of a favorable response after

established maintenance therapy with Remicade or other infliximab product.

Patient has NOT developed neutralizing antibodies to any infliximab product that has led to an attenuation of efficacy

of therapy. B. Diagnosis-Specific Criteria

“Infliximab” will be used to refer to all infliximab products.

Infliximab is proven and medically necessary for the treatment of: Ankylosing spondylitis when the following criterion is met:

o Diagnosis of ankylosing spondylitis (AS).



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UPDATED



Oct. 1, 2017

Crohn’s disease when the following criterion is met: o One of the following:

Diagnosis of fistulizing Crohn’s disease (Crohn’s Disease

Activity Index (CDAI) ≥ 220 and ≤ 400); or Both of the following:

- Diagnosis of moderately to severely active Crohn’s

disease; and - History of failure, contraindication, or intolerance to at

least one conventional therapy (e.g., corticosteroids, 6-mercaptopurine, azathioprine, methotrexate, etc.).

Noninfectious uveitis when BOTH of the following criteria are met: o Diagnosis of refractory noninfectious uveitis that is causing or

threatening vision loss (e.g., noninfectious uveitis associated with Behçet’s or Reiter’s syndromes); and

o History of failure, contraindication, or intolerance to ALL of the

following: Topical corticosteroids;

Systemic corticosteroids; Immunosuppressive drugs (e.g., azathioprine, cyclosporine,

or methotrexate). Plaque psoriasis when BOTH of the following criteria are met:

o Diagnosis of chronic severe plaque psoriasis i.e., extensive

and/or disabling); and o Patient is a candidate for systemic therapy.

Psoriatic arthritis when the following criterion is met: o Diagnosis of psoriatic arthritis (PsA).

Rheumatoid arthritis when BOTH of the following criteria are met:

o Diagnosis of moderately to severely active rheumatoid arthritis

(RA); and o One of the following:

Member is receiving concurrent therapy with methotrexate; History of contraindication or intolerance to methotrexate.

Sarcoidosis when ALL of the following criteria are met: o Diagnosis of sarcoidosis; and

o History of failure, contraindication, or intolerance to corticosteroids (e.g., prednisone, methylprednisolone); and

o History of failure, contraindication, or intolerance to one



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UPDATED



Oct. 1, 2017

immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine).

Ulcerative colitis when BOTH of the following criteria are met:

o Diagnosis of moderately to severely active ulcerative colitis (UC); and

o History of failure, contraindication, or intolerance to at least one

conventional therapy e.g., 6-mercaptopurine, aminosalicylate, azathioprine, corticosteroids.

There may be other conditions that qualify as serious, rare diseases for

which the use of infliximab may be appropriate. Please refer to the Benefit Considerations section of the policy for additional information.

Infliximab is unproven and not medically necessary in the treatment of: Still’s disease

Sjogren’s syndrome Graft-vs-host disease

Myelodysplastic syndromes Undifferentiated spondyloarthropathy Reiter’s syndrome Hidradenitis suppurativa Wegener’s granulomatosis

Juvenile idiopathic arthritis (juvenile rheumatoid arthritis)

Infliximab is unproven and not medically necessary for the treatment of the above conditions because statistically robust randomized controlled trials are needed to address the issue of whether Infliximab has sufficient superiority in clinical efficacy compared to other available treatments to

justify the inherent clinical risk in the use of a monoclonal antibody anti-

tumor necrosis factor agent.

Lithotripsy for Salivary Stones

Oct. 1, 2017

Updated supporting information to reflect the most current description of services, clinical evidence, FDA information and references; no change to non-coverage rationale or list of

applicable codes

Extracorporeal shock wave lithotripsy (ESWL) is unproven and not medically necessary for treating salivary stones. There is insufficient evidence to support the use of ESWL for managing salivary stones. Further research with randomized controlled studies is required to demonstrate the effectiveness of ESWL.

Endoscopic intracorporeal laser lithotripsy is unproven and not medically necessary for treating salivary stones.



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UPDATED

Lithotripsy for Salivary Stones (continued)

Oct. 1, 2017 The evidence regarding intracorporeal laser lithotripsy is limited and includes studies involving a small number of patients. Further research with randomized controlled studies and larger patient sample sizes is required to

demonstrate the effectiveness of endoscopic intracorporeal laser lithotripsy.

Nerve Graft to

Restore Erectile Function During Radical Prostatectomy

Oct. 1, 2017 Updated non-coverage rationale;

removed language indicating services are “considered” unproven and not medically necessary (no change to coverage guidelines)

Updated supporting information to reflect the most current clinical evidence and references

Sural or other nerve grafts to restore erectile function during radical

prostatectomy are unproven and not medically necessary. No comparative studies between nerve grafts and standard medical therapy (e.g., intracorporal injection or vacuum erection devices) have been completed. The evidence for nerve grafts for restoration of erectile function is derived mainly from non-randomized studies limited by small sample sizes.

A randomized controlled trial was discontinued when it was determined that unilateral nerve-sparing radical prostatectomy was not effective.

Plagiocephaly and Craniosynostosis Treatment

Oct. 1, 2017

Updated coverage rationale; replaced language indicating “cranial orthotic devices are

cosmetic and not medically

necessary in infants with mild to moderate plagiocephaly” with “cranial orthotic devices are cosmetic and not medically necessary for treating infants with mild to moderate plagiocephaly”

Updated supporting information to reflect the most current description of services, clinical evidence, and references

Cranial orthotic devices are reconstructive and medically necessary for: Craniosynostosis (i.e., synostotic plagiocephaly) following surgical

correction.

Treatment of craniofacial asymmetry in infants 3-18 months of age with severe nonsynostotic positional plagiocephaly when all the following criteria are present (1, 2 and 3): 1. Infant is 18 months of age or younger. 2. Severe asymmetry is present with or without torticollis. 3. There is documentation of a trial of conservative therapy of at least 2

months duration with cranial repositioning, with or without stretching

therapy. Severe plagiocephaly is defined as an asymmetry of 10 mm or more in one of the following anthropometric measures: cranial vault, skull base, or

orbitotragial depth; OR a cephalic index at least two standard deviations above or below the mean for the appropriate gender/age. Clinical evidence demonstrates improved surgical outcomes with the post-operative use of the

orthotic device. Note: Please see the Description of Services section of the policy for additional

information pertaining to Anthropometric measurements and the Cephalic Index graph.

Please see the list of Related Policies section of the policy for information



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UPDATED

Plagiocephaly and Craniosynostosis Treatment

(continued)

Oct. 1, 2017 pertaining to the repair and replacement of cranial orthotic devices.

Cranial orthotic devices are cosmetic and not medically necessary for treating infants with mild to moderate plagiocephaly. There are no definitive data demonstrating adverse health effects associated with a mild to moderate degree of cranial asymmetry, and, therefore, it is

unclear whether treatment of these individuals provides a future health benefit, or merely a cosmetic effect. In general, severe plagiocephaly occurs in utero and is present at birth. Limited clinical evidence suggests that it may be associated with future ocular and/or oral abnormalities. Acquired plagiocephaly occurs following the placement of the infant in a supine sleeping position to prevent sudden infant death syndrome, and is ordinarily

mild to moderate. Positional plagiocephaly has not been linked to future comorbidities.

Surgical treatment to repair craniosynostosis is reconstructive and medically necessary irrespective of the approach used.

Less invasive procedures including endoscopic strip craniectomy and

spring-mediated cranioplasty are proven and medically necessary as a form of surgical treatment to repair craniosynostosis.

Soliris® (Eculizumab)

Nov. 1, 2017

Updated list of related policies; added reference link to policy titled Maximum Dosage Policy

The guidelines below provide indications for the drug Soliris (eculizumab). Precertification is not required for the drug Soliris (eculizumab); however the

site of service for the administration of Soliris may require precertification.

Soliris (eculizumab) is proven and medically necessary for the

treatment of: 1. Atypical hemolytic uremic syndrome (aHUS) 2. Paroxysmal nocturnal hemoglobinuria (PNH)

Soliris is unproven and not medically necessary for treatment of Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). Site of Care Administration

Provider’s Office or Freestanding Ambulatory Infusion Suite (not associated with a hospital)

Administration of Soliris in a provider’s office or freestanding ambulatory infusion suite not associated with a hospital does not require precertification.



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UPDATED

Soliris® (Eculizumab) (continued)

Nov. 1, 2017 Home Administration

Administration of Soliris in the home requires pre-certification for the home care services (not for the Soliris itself). Refer to the policy titled Home Health Care.

Hospital Outpatient Facility

Administration of Soliris in a hospital outpatient facility (including any

ambulatory infusion suite associated with the hospital) requires precertification with review by a Medical Director or their designee. Refer to the policy titled Specialty Medication Administration - Site of Care Review Guidelines.

Unicondylar Spacer Devices for Treatment of Pain or Disability

Oct. 1, 2017 Updated supporting information to reflect the most current description of services, FDA information, and references; no

change to non-coverage

rationale or list of applicable codes

Unicondylar spacer devices are unproven and not medically necessary for treating knee joint pain or disability from any cause. The evidence is lacking to demonstrate that unicondylar spacers are clinically effective, and long-term data are not available to establish the safety and

efficacy of these devices. Published evidence consists of small studies with

mixed results. It is not evident that this treatment postpones or obviates the need for total joint replacement.


REVISED

Abnormal Uterine Bleeding and

Uterine Fibroids

Nov. 1, 2017

Updated conditions of coverage; removed notation indicating this

policy describes minimally invasive treatments used to treat uterine fibroids and reduce excessive blood loss in women with abnormal uterine bleeding

Updated benefit considerations; modified language pertaining to

coverage for unproven services to indicate: o Most plan documents provide

coverage for unproven and not medically necessary services for a life-

threatening sickness or condition, at our discretion;

Levonorgestrel-Releasing Intrauterine Device

Levonorgestrel-releasing intrauterine devices (LNG-IUD) (e.g., Mirena®, Skyla®

, Liletta® or Kyleena™) are proven and medically

necessary for treating menorrhagia.

See the U.S. Food and Drug Administration (FDA) section of the policy for additional information. Uterine Fibroids

Uterine artery embolization (UAE) is proven and medically necessary for treating symptomatic uterine fibroids for women who do NOT wish to preserve their childbearing potential which has been documented and confirmed in the medical record. For information regarding medical necessity review, when applicable, see

MCG™ Care Guidelines, 21st edition, 2017, Uterine Artery Embolization, ACG: A-0287 (AC).

Uterine artery embolization (UAE) is unproven and not medically



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REVISED

Abnormal Uterine Bleeding and Uterine Fibroids

(continued)

Nov. 1, 2017

additionally, some plan documents may provide coverage for unproven and

not medically necessary services under certain non-life-threatening conditions at

our discretion o Magnetic resonance-guided

focused ultrasound (MRgFUS) is a covered

service for certain benefit plans

o Other terms and conditions to claims payment may apply, depending on the terms of the member specific

benefit plan document, a provider’s participation

agreement, and the Oxford Supplement to the UnitedHealthcare Administrative Guide; providers should refer to the

current Oxford Commercial Supplement to the UnitedHealthcare Administrative Guide for additional details, available at UHCprovider.com/guides

> UnitedHealthcare

Administrative Guide Revised coverage rationale;

modified language pertaining to treatment of uterine fibroids to indicate uterine artery embolization (UAE) is proven

and medically necessary for treating symptomatic uterine fibroids for women who do not

necessary for treating symptomatic uterine fibroids for women who wish to preserve their childbearing potential. The effects of UAE on ovarian and uterine function and on fertility are

relatively unknown. Further studies of safety and/or efficacy in published, peer-reviewed medical literature are necessary.

Magnetic resonance guided focused ultrasound ablation (MRqFUS) is unproven and not medically necessary for treating uterine fibroids. Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative to other treatment options for uterine fibroids. See the Benefit Considerations section of the policy for potential coverage of unproven

services.

Laparoscopic ultrasound-guided radiofrequency ablation (e.g.,

Acessa™) is unproven and not medically necessary for treating uterine fibroids. Further studies are needed to determine the long-term efficacy of this

procedure and to evaluate the efficacy and safety of this procedure relative to other treatment options for uterine fibroids.

Transcervical ultrasound-guided radiofrequency ablation is investigational, unproven and not medically necessary for treating uterine fibroids due to lack of FDA approval.

Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative to other treatment options for uterine fibroids.



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REVISED

Abnormal Uterine Bleeding and Uterine Fibroids

(continued)

Nov. 1, 2017 wish to preserve their childbearing potential which has been documented and confirmed

in the medical record Updated supporting information

to reflect the most current

clinical evidence and references

Drug Coverage Criteria - New and Therapeutic

Equivalent Medications

Nov. 1, 2017

Revised list of medications requiring precertification through the pharmacy benefit manager

(PBM): o Removed Minocycline

Extended-Release (generic Solodyn), Tymlos, and Xatmep

o Updated formulary alternatives for Epiduo Forte

and Ilevro Revised coverage criteria for

Amphetamine/Dextroamphetamine Extended-Release (generic Adderall XR) and Methylphenidate Extended-

Release Tablet (generic Concerta); added notation to indicate the care provider must give an explanation of potential rationale for how the excluded medication will work if stating

the patient failed on the covered

therapeutically equivalent product which has the same active ingredient (e.g., the member had an adverse reaction to an inactive ingredient in the alternative product)

Refer to the policy for complete details on Drug Coverage Criteria - New and Therapeutic Equivalent Medications.



Oxford

Policy Title Effective Date Drug/Medication Status Summary of Changes

REVISED

Drug Coverage Guidelines

Oct. 1, 2017 Renflexis (Infliximab) Updated Updated list of applicable HCPCS codes to reflect quarterly code edits; added modifier ZC (Merck) to Q5102

Drug Coverage Guidelines

Nov. 1, 2017 Updated Prior Authorization/Notification Guidelines: Interim New Product Coverage Criteria; refer to the policy for complete details

Alecensa (Alectinib) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Alecensa for complete details

Cinqair (Reslizumab) Updated Updated reference link to reflect title change for Precertification Guidelines: Respiratory Interleukins (Cinqair and Nucala); previously titled Precertification Guidelines: Respiratory Interleukins (IL) Policy

Daklinza (Daclatasvir) Revised Reformatted and revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Daklinza for complete details

Entyvio (Vedolizumab) Revised Added medical management guidelines; refer to Medical Management Guidelines: Maximum Dosage Policy for complete details

Epclusa (Sofosbuvir/Velpatasfir)

Revised Reformatted and revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines:

Epclusa for complete details

Haegarda [C1 Esterase Inhibitor Subcutaneous (Human)]

Revised Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Haegarda for complete details

Harvoni™

(Ledipasvir/Sofosbuvir)

Revised Reformatted and revised prior authorization/medical necessity

guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Harvoni for complete details

Humira (Adalimumab) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Humira for complete details

Inflectra (Infliximab) Updated Updated list of applicable HCPCS codes; added modifier ZB (Pfizer) to Q5102

Incivek (Telaprevir) Removed Removed coverage guidelines

Kalydeco (Ivacaftor) Revised Revised prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Kalydeco for complete details

Kymriah (Tisagenlecleucel) – [CAR-T (Chimeric

Antigen Receptor) Cell Therapy]

New

Added coverage guidelines to indicate: o Chimeric Antigen Receptor (CAR)-T Cell Therapy may be eligible for

coverage as an autologous stem cell therapy under a member’s

Transplantation Services benefit o Coverage determinations are based on the Optum Transplant Review

Guidelines: Hematopoietic Stem Cell Transplantation criteria for covered transplants

o Precertification through Optum is required for all sites of service



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REVISED

Drug Coverage Guidelines (continued)

Nov. 1, 2017 Kymriah (Tisagenlecleucel) – [CAR-T (Chimeric

Antigen Receptor) Cell Therapy] (continued)

New o Refer to the following policies for complete details: eviCore Guidelines: Injectable Chemotherapy Drugs: Application

of NCCN Clinical Practice Guidelines

Optum Transplant Review Guidelines: Hematopoietic Stem Cell Transplantation

Mavyret (Glecaprevir and Pibrentasvir)

Revised Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Mavyret for complete details

Minocycline Extended-Release (Generic Solodyn)

Revised Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Solodyn for complete details

Removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Nucala (Mepolizumab) Updated Updated reference link to reflect title change for Precertification Guidelines: Respiratory Interleukins (Cinqair and Nucala); previously titled Precertification Guidelines: Respiratory Interleukins (IL)

Olysio (Simeprevir) Revised Reformatted and revised prior authorization/medical necessity

guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Olysio for complete details

Orencia (Abatacept): SQ Injection

Revised

Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Orencia for complete details

Revised step therapy guidelines; refer to Step Therapy Guidelines: Orencia for complete details

Oxistat (Oxiconazole Nitrate)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Oxistat for complete details

Rebetol (Ribavirin) Revised Removed prior authorization/notification guidelines and corresponding reference link to policy titled Prior Authorization/Notification Guidelines: Rebetol (Ribavirin)

Renflexis (Infliximab) Revised Added medical management guidelines; refer to Medical Management

Guidelines: Maximum Dosage Policy for complete details

Repronex (Menotropins) Removed Removed coverage guidelines

Sensipar (Cinacalcet) Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Sensipar for complete details

Soliris (Eculizumab) Revised Added medical management guidelines; refer to Medical Management Guidelines: Maximum Dosage Policy for complete details

Solodyn (Minocycline HCL)

Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Solodyn for complete details

Sovaldi (Sofosbuvir) Revised Reformatted and revised prior authorization/medical necessity



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REVISED


Nov. 1, 2017 Sovaldi (Sofosbuvir) (continued)

Revised guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Sovaldi for complete details

Stelara (Ustekinumab): Sub-Cutaneous Injection

Revised Added medical management guidelines; refer to Medical Management Guidelines: Maximum Dosage Policy for complete details

Stelara (Ustekinumab): Intraveneous Infusion

Updated Updated list of applicable CPT/HCPCS codes; replaced J3590 with Q9989

Technivie (Ombitasvir/Paritaprevir/ Ritonavir)

Revised Reformatted and revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Technivie for complete details

Triptodur (Triptorelin) New Added coverage guidelines to indicate precertification is required for the diagnosis of gender dysphoria through Oxford’s Medical Management; refer to Precertification Guidelines: Gonadotropin Releasing Hormone

Analogs for complete details

Tymlos (Abaloparatide) Revised Removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Victrelis (Boceprevir) Removed Removed coverage guidelines

Viekira Pak Viekira XR (Ombitasvir, Paritaprevir (ABT-450) and Ritonavir)

Revised Reformatted and revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Viekira Pak for complete details

Vosevi (Sofosbuvir/Velpatasvir/ Voxilaprevir)

Revised Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Vosevi for complete details

Xolair (Omalizumab) Revised Added medical management guidelines; refer to Medical Management


Xatmep (Methotrexate) Revised Removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Xeljanz (Tofacitinib) Revised Revised prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Xeljanz for complete details

Xeljanz XR Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Xeljanz for complete details

Xolair (omalizumab) Revised Added medical management guidelines; refer to Medical Management


Xtandi (Enzalutamide) Revised Revised step therapy guidelines; refer to Step Therapy Guidelines: Xtandi for complete details



Oxford


REVISED


Nov. 1, 2017 Zepatier (Elbasvir/Grazoprevir)

Revised Reformatted and revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Zepatier for complete details

Zovirax Ointment Updated Updated prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Zovirax for complete details


REVISED

Follicle Stimulating

Hormone (FSH) Gonadotropins

Nov. 1, 2017

Revised coverage rationale:

o Updated coverage criteria for initial and continuation of therapy; replaced criterion requiring “antral follicle count >7” with “antral follicle count >6”

o Updated coverage guidelines

for controlled ovarian stimulation:

Modified list of unproven/not medically necessary situations; added “in the setting of

in the setting of very poor/futile prognosis, defined as a FSH level ≥15 mlU/ml if ≥40 years of age or FSH level ≥20 mlU/ml if <40 years of age”

o Updated coverage guidelines for hypogonadotropic hypogonadism: Removed gender-specific

language; replaced reference to “male hypogonadotropic

hypogonadism” with “hypogonadotropic hypogonadism”

Oxford has engaged Optum to perform reviews of requests for pre-

certification (Oxford continues to be responsible for decisions to limit or deny coverage and for appeals). All authorization/pre-certification requests are handled by Optum. To pre-certify a procedure related to the treatment of infertility, please call Optum at 877-512-9340. This policy addresses the following gonadotropins: Bravelle (urofollitropin)

Gonal-f/Gonal-f RFF (follitropin alfa) Follistim AQ (follitropin beta)

All follicle stimulating hormone (FSH) gonadotropins currently available on the U.S. market are considered to be therapeutically equivalent.

The clinically appropriate dosing for FSH agents is 450 IU per day or less for an assisted reproductive technology (ART) cycle when administered alone. The total dose of gonadotropin should not exceed 450 IU per day when used in any mixed stimulation protocol of FSH and human menopausal gonadotropin (hMG) (e.g., FSH 300 IU/day with hMG 150 IU/day), for not more than 14 days of treatment. Exceeding this daily dose and duration of treatment has not been proven to be efficacious in terms of pregnancy

outcome. The clinically appropriate dosing for FSH agents is 150 IU/day or less when used for ovulation induction, or controlled ovarian stimulation, for not more than 14 days of treatment. Exceeding this daily dose and duration of treatment has not been proven to be efficacious in terms of pregnancy outcome.

The following information pertains to medical necessity review:



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REVISED

Follicle Stimulating Hormone (FSH) Gonadotropins

(continued)

Nov. 1, 2017

General Requirements (applicable to all medical necessity requests):

For initial and continuation of therapy, ALL of the following must be met for consideration of treatment: Prognosis for conception must be ≥ 5%; and Adequate ovarian reserve as indicated but not limited to at least one the

following markers (one or more of the following within the previous 6 months): o FSH level < 15 mIU/ml if > 35 years of age; or o FSH level < 20 mIU/ml if ≤ 35 years of age; or o AMH level > 0.3 ng/ml; or o Antral follicle count > 6; and

Evidence of adequate ovarian response to stimulation if there has been previously monitored, medicated-stimulated infertility treatment within the previous 6 months. Examples of adequate ovarian response are: o One follicle ≥ 15 mm diameter for IUI o Minimum of 1 follicle ≥ 15 mm diameter for ART

Preferred Product: Gonal-f and Gonal-f RFF* are the preferred FSH agents

Infertility treatment with Follistim AQ or Bravelle is medically

necessary for the indications specified in this policy when ONE of the following criteria are met: History of failure, contraindication, or intolerance to Gonal-f or Gonal-f

RFF; or Both of the following:

o Patient is currently on Follistim AQ or Bravelle therapy; and

o One of the following: Patient has not received a manufacturer supplied sample at no

cost from a prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Follistim AQ or Bravelle; or

Both of the following: - Patient has received a manufacturer supplied sample at no

cost from a prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Follistim AQ or Bravelle; and

- History of failure, contraindication, or intolerance to Gonal-f or Gonal-f RFF.



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REVISED


(continued)

Nov. 1, 2017

Diagnosis-Specific Requirements

The information below indicates additional requirements for those indications having specific medical necessity criteria in the list of proven indications.

FSH gonadotropins are proven and medically necessary for:

Ovulation Induction

Gonadotropins are proven and medically necessary for the treatment of ovulatory dysfunction when ONE of the following criteria are met: Anovulation; or Oligo-ovulation; or All of the following:

o Amenorrhea; and o Other specific causative factors (e.g., thyroid disease,

hyperprolactinemia) have been excluded or treated; and o Failure to ovulate with either Clomid (clomiphene citrate) or Femara

(letrozole);

and One of the following:

o For assisted reproductive technologies (ART), dose does not exceed 450 IU/day, for no more than 14 days per cycle; or

o For ovulation induction, dose does not exceed 150 IU/day, for no more than 14 days per cycle.

Gonadotropins are unproven and not medically necessary for the treatment of ovulatory dysfunction in the following situations: Beyond the 6th gonadotropin induced ovulatory cycle.

When there are ≥ 4 follicles which are ≥15 mm in diameter from a previously gonadotropin-induced ovulation, despite a dosage adjustment

(e.g., doses of gonadotropin down to 37.5 IU per day). When used alone for individuals with unexplained infertility. When there is a failure to respond to ovulation stimulation, (e.g., doses

of gonadotropins up to 225 IU per day and no follicles ≥ 15 mm in diameter).

In lieu of clomiphene or letrozole to correct a thin endometrial lining. An estradiol level <100 pg/ml/follicle ≥15 mm in diameter. Doses that exceed 450 IU/day for ART or 150 IU/day for ovulation

induction, respectively. Duration of therapy that exceeds 14 days per cycle.



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REVISED


(continued)

Nov. 1, 2017

Controlled Ovarian Stimulation

Gonadotropins are proven and medically necessary for the treatment of controlled ovarian stimulation when all of the following criteria are met: Used alone or in conjunction with intrauterine insemination; and

One of the following: o Treatment in individuals with diminished ovarian reserve that have

not responded to clomiphene or letrozole; or o Initial treatment for individuals with diminished ovarian reserve; or o Initial treatment for individuals ≥ 40 years of age; or o In the setting of unilateral tubal disease when there is no evidence of

tubal compromise on the patent side when at least 2 cycles of oral

agents (clomiphene or letrozole) have failed to yield a dominant follicle on the side with a patent fallopian tube;


o For assisted reproductive technologies (ART), dose does not exceed

450 IU/day, for no more than 14 days per cycle; or o For controlled ovulation stimulation, dose does not exceed 150

IU/day, for no more than 14 days per cycle.

Gonadotropins are unproven and not medically necessary for the treatment of controlled ovarian stimulation in the following situations: Treatment in individuals with unexplained infertility, endometriosis,

bilateral tubal factor infertility, recurrent pregnancy loss or male factor infertility.

In lieu of clomiphene or letrozole to correct a thin endometrial lining. When there is a failure to respond to ovarian stimulation, (e.g., doses of

gonadotropins up to 225 IU per day and no follicles ≥ 15 mm in diameter).

An estradiol level <100 pg/ml/follicle ≥15 mm in diameter).

When there are ≥ 4 follicles which are ≥15 mm in diameter from a previously gonadotropin-induced ovulation, despite a dosage adjustment.

Following ART cycles that fail to result in conception due to poor ovarian response or poor quality oocytes or embryos.

Doses that exceed 450 IU/day for ART or 150 IU/day for controlled ovulation stimulation, respectively.

Duration of therapy that exceeds 14 days per cycle.



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REVISED


(continued)

Nov. 1, 2017

Beyond 4 cycles for individuals age <38, 2 cycles for individuals age 38-39, and 1 cycle for individuals age 40 and older in the setting ovarian stimulation for diminished ovarian reserve.

In the setting of very poor/futile prognosis, defined as a FSH level ≥15 mlU/ml if ≥40 years of age or FSH level ≥20 mlU/ml if <40 years of age.

Hypogonadotropic Hypogonadism

Gonadotropins are proven and medically necessary for the treatment of hypogonadotropic hypogonadism when ALL of the following criteria are met: One of the following:

o Diagnosis of primary hypogonadotropic hypogonadism; or

o Diagnosis of secondary hypogonadotropic hypogonadism; and

For the induction of spermatogenesis; and Infertility is not due to primary testicular failure.

Gene Expression

Tests for Cardiac Indications

Nov. 1, 2017

Changed policy title; previously

titled Gene Expression Tests Updated list of related policies;

removed reference link to the policy titled Chemosensitivity and Chemoresistance Assays in Cancer

Revised coverage rationale; removed content/language pertaining to oncology

indications (refer to the policy titled Molecular Oncology Testing for Cancer Diagnosis, Prognosis,

and Treatment Decisions for applicable coverage guidelines)

Updated list of applicable CPT

codes; removed 0005U, 81479, 81504, 81525, 81540, 81545, 81599, 84999, and 88299

Updated supporting information to reflect the most current description of services, clinical

Coronary Artery Disease

Gene expression tests are unproven and not medically necessary for predicting the likelihood of obstructive coronary artery disease (e.g., Corus® CAD). There is insufficient evidence in the clinical literature demonstrating that this

test has a role in clinical decision-making or has a beneficial effect on health outcomes. Further studies are needed to determine the clinical utility of this test.



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REVISED

Gene Expression Tests for Cardiac Indications

(continued)

Nov. 1, 2017 evidence, FDA information, and references

Genetic Testing for

Hereditary Cancer

Nov. 1, 2017

Changed policy title; previously

titled Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC)

Updated list of related policies;

added reference link to policy titled Preventive Care Services

Revised conditions of coverage/authorization requirements; removed language pertaining to CPT code 96040 and HCPCS code S0265

Reformatted and revised coverage rationale: o Removed definitions and

corresponding notations o Removed language

pertaining to medical

necessity review and documentation requirements for genetic counseling

o Added language to indicate genetic counseling is strongly recommended prior

to [genetic testing] in order

to inform persons being tested about the advantages and limitations of the test as applied to a unique person

o Updated coverage guidelines for Hereditary Breast and Ovarian Cancer

(BRCA1/BRCA2): Removed language

Genetic counseling is strongly recommended prior to these tests in order to

inform persons being tested about the advantages and limitations of the test as applied to a unique person.

Hereditary Breast and Ovarian Cancer (BRCA1/BRCA2)

Genetic testing for BRCA1 and BRCA2 for individuals with a personal

history of a related cancer is proven and medically necessary in the following situations: Women with a personal history of breast cancer in the following

situations: o Breast cancer diagnosed at any age in an individual with at least one

close (1st-, 2nd-, and 3rd-degree relative) blood relative who has a BRCA1 or BRCA2 mutation (testing should be targeted to the known

BRCA1/BRCA2 mutation in the family. Further BRCA1/BRCA2 testing should only be pursued if the results are negative and the patient otherwise meets testing criteria)

o Breast cancer diagnosed at any age in an individual from one of the following ethnic groups associated with founder mutations: Ashkenazi Jewish (Testing for Ashkenazi Jewish founder-specific

mutations should be performed first. Further BRCA1/BRCA2

testing should only be pursued if the results are negative and the patient otherwise meets testing criteria without considering Ashkenazi Jewish ancestry.)

Breast cancer diagnosed at age 45 or younger or “triple-negative” (Her2 negative, ER negative and PR negative) breast

cancer diagnosed at age 60 or younger; or breast cancer

diagnosed at age 50 or younger with: - Bilateral breast cancer; or - A personal history of a prior primary breast cancer diagnosis;

or - At least one close blood relative with breast cancer; or - At least one close blood relative with pancreatic cancer; or - At least one close blood relative with prostate cancer; or

- An unknown or limited family history (see the Definitions section of the policy for further clarification of limited family



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REVISED

Genetic Testing for Hereditary Cancer (continued)

Nov. 1, 2017

indicating: - Comprehensive

BRCA1/BRCA2

genetic testing includes sequencing of both BRCA1 and

BRCA2 genes and analysis for large genomic rearrangements,

either concurrently or sequentially; NCCN guidelines emphasize the need for comprehensive testing for

individuals who meet the testing criteria

for BRCA1/BRCA2 and have no known familial BRCA1/BRCA2 mutations who have

undergone accurate risk assessment and genetic counseling

- NCCN guidelines state that significant limitations of

interpreting test

results for an individual without a cancer diagnosis should be discussed: If there are no

living family

members with breast or ovarian cancer available

history). o Breast cancer diagnosed at any age with:

At least one close male blood relative with breast cancer

diagnosed at any age; or At least one close blood relative with breast cancer diagnosed at

age 50 or younger; or

At least two close blood relatives on the same side of the family with breast cancer at any age; or

At least one close blood relative with ovarian cancer at any age; or

At least two close blood relatives on the same side of the family with pancreatic and/or prostate cancer at any age.

o Metastatic breast cancer and may be a candidate for treatment with a PARP inhibitor (e.g., olaparib).

Men with a personal history of breast cancer. Women with a personal history of ovarian cancer.

Women and men with a personal history of pancreatic cancer at any age and at least one close blood relative with (a) ovarian cancer at any age

or (b) breast cancer diagnosed with at age 50 or younger or (c) two relatives on the same side of the family with breast, pancreatic and/or prostate cancer at any age.

Women and men with a personal history of pancreatic cancer and Ashkenazi Jewish ancestry. Testing should be targeted to the known

Ashkenazi Jewish founder-specific mutations. Men with a personal history of high risk prostate cancer (Gleason score

≥7) at any age; and o At least one close blood relative with ovarian cancer at any age or

breast cancer (≤ age 50 years); or o At least two close relatives on the same side of the family with

breast, pancreatic and/or prostate cancer at any age.

Genetic testing for BRCA1 and BRCA2 for individuals without a personal history of a related cancer is proven and medically necessary in the following situations: When there is a known BRCA1/BRCA2 mutation in a close blood relative

(defined as first-, second- or third-degree relative). Testing should be

targeted to the known BRCA1/BRCA2 mutation in the family. Further BRCA1/BRCA2 testing should only be pursued if the results are negative and the patient otherwise meets other testing criteria.



Oxford


REVISED


Nov. 1, 2017

for testing, consider testing family members

affected with other cancers associated with

BRCA1/BRCA2, such as prostate cancer (Gleason score ≥7),

pancreatic cancer or melanoma

Testing of individuals without a cancer

diagnosis should only be

considered when there is no affected family member available for

testing Added language to

indicate genetic testing for BRCA1 and BRCA2 is proven and medically necessary for women

with a personal history

of metastatic breast cancer and may be a candidate for treatment with a PARP inhibitor (e.g., olaparib)

o Added coverage guidelines

for Multi-Gene Hereditary Cancer Panel Testing to indicate:

When there is at least one of the following familial risk factors: o At least one first- or second-degree blood relative meeting any of the

above criteria for individuals with a personal history of a related

cancer; or o At least one third-degree blood relative with breast cancer and/or

ovarian cancer who has at least 2 close blood relatives with breast

cancer (at least one with breast cancer at age 50 or younger) and/or ovarian cancer.

Genetic testing for BRCA1 and/or BRCA2 testing is unproven and not

medically necessary for all other indications including: Screening for breast or ovarian cancer risk for individuals not listed in the

proven indications above; or For risk assessment of other cancers. Further evidence is needed to

establish the clinical utility of testing in other populations. Multi-Gene Hereditary Cancer Panel Testing Criteria:

Genetic testing with a multi-gene hereditary cancer panel in individuals with an indication for testing for hereditary breast and

ovarian cancer is proven and medically necessary if all of the following criteria are met: The patient meets at least one of the criteria in Hereditary Breast and

Ovarian Cancer (BRCA1/BRCA2) (see above section); and The patient has a family history or personal history that is strongly

suggestive of more than one hereditary cancer syndrome; and

The suspected hereditary cancer syndromes can be diagnosed by testing of one or more genes included in the specific hereditary cancer panel; and

The results of testing the will directly impact this patient’s medical

management. Genetic testing with a multi-gene cancer panel in individuals with an

indication for testing for hereditary colorectal cancer is proven and medically necessary in the following situations: The patient meets at least one of the following criteria for a hereditary

colorectal cancer (Lynch) syndrome: o Men with a personal history of colorectal cancer or women with a

personal history of colorectal or endometrial cancer diagnosed at age 49 or younger; or



Oxford


REVISED


Nov. 1, 2017

Genetic testing with a multi-gene hereditary cancer panel in

individuals with an indication for testing for hereditary breast and

ovarian cancer is proven and medically necessary if all of the following criteria are met:

- The patient meets at least one of the criteria in Hereditary Breast and Ovarian Cancer (BRCA1/BRCA2)

section of the policy; and

- The patient has a family history or personal history that is strongly suggestive of more

than one hereditary cancer syndrome; and

- The suspected hereditary cancer syndromes can be

diagnosed by testing

of one or more genes included in the specific hereditary cancer panel; and

- The results of testing the will directly

impact this patient’s medical management

o Men with a personal history of colorectal cancer or women with a personal history of colorectal or endometrial cancer diagnosed at age 50 or later with at least one of the following criteria:

A personal history of another cancer associated with Lynch Syndrome; or

At least one first-degree relative with colorectal or endometrial

cancer diagnosed at age 49 or younger; or At least two close relatives with a cancer associated with Lynch

Syndrome; or Tumor testing results showing that their colorectal or endometrial

cancer was MSI-high or had immunohistochemical (IHC) staining showing the absence of one or more mismatch repair proteins (MLH1, MSH2, MSH6 or PMS2); or

PREMM 1,2,6 score of 5% or greater or

o A personal history of colorectal polyposis with at least 10

adenomatous polyps; or o At least one close blood relative meeting the criteria for Lynch

Syndrome (as defined in the first two criteria above) or with a clinical diagnosis of familial adenomatous polyposis in whom genetic testing was not or cannot be completed; or

o PREMM5 score of 2.5% or greater or PREMM1, 2, 6 score of 5% or greater for having a Lynch syndrome gene mutation

and The suspected hereditary cancer syndromes can be diagnosed by testing


The results of testing the will directly impact this patient’s medical management.

Genetic testing with a multi-gene hereditary cancer panel in individuals without an indication for testing for hereditary breast and ovarian cancer or colorectal cancer is proven and medically necessary in the following situations: The patient has a family history or personal history that is strongly

suggestive of more than one hereditary cancer syndrome; and

The suspected hereditary cancer syndromes can be diagnosed by testing of one or more genes included in the specific hereditary cancer panel; and



Oxford


REVISED


Nov. 1, 2017

Genetic testing with a multi-gene cancer panel in individuals with an

indication for testing for hereditary colorectal cancer is proven and

medically necessary in the following situations: - The patient meets at

least one of the

following criteria for a hereditary colorectal cancer (Lynch) syndrome: Men with a

personal history

of colorectal cancer or women

with a personal history of colorectal or endometrial cancer diagnosed

at age 49 or younger; or

Men with a personal history of colorectal cancer or women

with a personal

history of colorectal or endometrial cancer diagnosed at age 50 or later with

at least one of the following criteria:

The results of testing the will directly impact this patient’s medical management.

Genetic testing with a multi-gene cancer panel is proven and medically necessary in a patient who has previously tested negative (indeterminate) for the high penetrance genes that are most likely to

explain the personal or family history of cancer (e.g., BRCA1/2 for breast cancer and ovarian cancer)in the following situations: The patient’s personal and family history remains strongly suggestive of

an inherited susceptibility that can be diagnosed by testing of one or

more genes included in the specific hereditary cancer panel; and The results of testing the will directly impact this patient’s medical

management. Multi-gene hereditary cancer panels are unproven and not medically necessary for all other indications.



Oxford


REVISED


Nov. 1, 2017

o A personal history of another cancer

associated with Lynch Syndrome; or

o At least one first-degree relative with colorectal or endometrial

cancer diagnosed at age 49 or younger; or

o At least two close relatives with a cancer

associated with Lynch

Syndrome; or o Tumor testing

results showing that their colorectal or

endometrial cancer was MSI-high or had immunohistochemical (IHC) staining showing

the absence of

one or more mismatch repair proteins (MLH1, MSH2, MSH6 or PMS2); or

o PREMM 1,2,6

score of 5% or greater or



Oxford


REVISED


Nov. 1, 2017

A personal history of colorectal

polyposis with at least 10 adenomatous

polyps; or At least one

close blood relative meeting

the criteria for Lynch Syndrome (as defined in the first two criteria above) or with a clinical

diagnosis of familial

adenomatous polyposis in whom genetic testing was not or cannot be

completed; or PREMM5 score of

2.5% or greater or PREMM1,2,6 score of 5% or greater for

having a Lynch

Syndrome gene mutation

and - The suspected

hereditary cancer syndromes can be

diagnosed by testing of one or more genes included in the



Oxford


REVISED


Nov. 1, 2017

specific hereditary cancer panel; and

- The results of testing

the will directly impact this patient’s medical

management Genetic testing with a

multi-gene hereditary cancer panel in

individuals without an indication for testing for hereditary breast and ovarian cancer or colorectal cancer is proven and medically

necessary in the following situations:

- The patient has a family history or personal history that is strongly suggestive of more

than one hereditary cancer syndrome; and

- The suspected hereditary cancer syndromes can be

diagnosed by testing



impact this patient’s medical management



Oxford


REVISED


Nov. 1, 2017

Genetic testing with a multi-gene cancer panel is proven and medically

necessary in a patient has previously tested negative (indeterminate)

for the high penetrance genes that are most likely to explain the personal or family

history of cancer (e.g., BRCA1/2 for breast cancer and ovarian cancer) in the following situations: - The patient’s

personal and family history remains

strongly suggestive of an inherited susceptibility that can be diagnosed by testing of one or

more genes included in the specific hereditary cancer panel; and


impact this patient’s

medical management

Multi-gene hereditary cancer panels are unproven and not medically necessary for

all other indications Updated definitions:

o Revised definition of “1st,



Oxford


REVISED


Nov. 1, 2017

2nd, and 3rd degree relatives” (relocated from Coverage Rationale section of the

policy) o Added definition of “PREMM”

(prediction model for gene

mutations) Updated list of applicable CPT

codes; removed 96040 Removed list of applicable

HCPCS codes: S0265 Updated supporting information

to reflect the most current description of services, clinical evidence, FDA information, and references

Gonadotropin

Releasing Hormone Analogs

Nov. 1, 2017

Revised coverage rationale:

o Updated list of applicable gonadotropin releasing hormone analog (GnRH analog) drug products; added Triptodur (triptorelin)

o Added language to indicate:

Triptodur is medically necessary for the treatment of central precocious puberty when all of the listed criteria are met

Triptodur treatment

should be discontinued at the appropriate age of onset of puberty at the discretion of the physician

o Updated coverage guidelines for treatment of

endometriosis: Replaced references to

Please refer to the policy titled Injectable Chemotherapy Drugs: Application

of NCCN Clinical Practice Guidelines for updated information based on the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® (NCCN Compendium®) for oncology indications.

This policy refers to the following gonadotropin releasing hormone analog (GnRH analog) drug products: Firmagon (degarelix) Lupron Depot (leuprolide acetate) Lupron Depot-Ped (leuprolide acetate)

Supprelin LA (histrelin acetate) Trelstar (triptorelin pamoate) Triptodur (triptorelin)

Vantas (histrelin acetate) Zoladex (goserelin acetate)

For the coverage criteria below, in absence of specified drug products, the term “GnRH analogs” will be used in this policy where the coverage criteria apply to all products listed above.

Covered Indications

Central Precocious Puberty (Lupron Depot-Ped, Supprelin LA)

Lupron Depot-Ped and Supprelin LA are proven for the treatment of



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REVISED

Gonadotropin Releasing Hormone Analogs

(continued)

Nov. 1, 2017

diagnosis/treatment of “endometriosis” with “endometriosis or

suspected endometriosis”

Modified medical

necessity criteria for initial therapy: - Updated list of drug

products to which

contraindication, intolerance, or therapeutic failure must be demonstrated; replaced “oral

contraceptives” with “oral contraceptives

or depot medroxyprogesterone (e.g., Depot Provera)”


for the treatment of fertility preservation; added language to clarify GnRH analogs are proven and medically necessary for the treatment of fertility

preservation when all of the

listed criteria are met Updated list of applicable HCPCS

codes; added J3490 Updated supporting information

to reflect the most current background information, clinical

evidence, FDA information, and references

Central precocious puberty. Lupron Depot-Ped, Supprelin LA, and Triptodur are medically

necessary for the treatment of central precocious puberty when ALL of the following criteria are met: Diagnosis of central precocious puberty (idiopathic or neurogenic); and

Onset of secondary sexual characteristics in one of the following: o Females ≤ 8 years of age o Males ≤9 years of age and

Confirmation of diagnosis as defined by one of the following: o Pubertal basal level of luteinizing hormone (based on laboratory

reference ranges) o Pubertal luteinizing hormone response to a GnRH stimulation test o Bone age advanced one year beyond the chronological age

Lupron Depot-Ped, Supprelin LA, or Triptodur treatment should be discontinued at the appropriate age of onset of puberty at the discretion of

the physician.1 Give consideration to discontinuing treatment before 11 years of age in girls and 12 years of age in boys. Endometriosis (Lupron Depot, Zoladex)

Lupron Depot and Zoladex are proven for the treatment of endometriosis or suspected endometriosis.

Lupron Depot and Zoladex are medically necessary for the treatment of endometriosis when ALL of the following criteria are met: For initial therapy, all of the following:

o Diagnosis of endometriosis or endometriosis is suspected; and

o One of the following: Contraindication, intolerance, or failure of initial treatment with

both of the following:

- Oral contraceptives or depot medroxyprogesterone (e.g., Depot Provera) and

- Non-steroidal anti-inflammatory drugs (NSAIDs); or

Patient has had surgical ablation to prevent recurrence; and o Initial treatment course is limited to a maximum of 6 months.

For retreatment, all of the following (Lupron Depot ONLY):



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REVISED


(continued)

Nov. 1, 2017

o Diagnosis of endometriosis or suspected endometriosis; and o Recurrence of symptoms following an initial course of therapy; and o Concurrently to be used with add-back therapy (e.g., progestins,

estrogen, or bone sparing agents); and o Duration of both the initial and recurrent course of therapies is no

longer than 12 months total.

Zoladex is not recommended for the retreatment of endometriosis, per FDA labelling.

The prescribing information for Lupron Depot and Zoladex states that the duration of initial treatment for endometriosis should be limited to 6 months.

For Lupron Depot for recurrence of symptoms, the prescriber should consider the impact to bone mineral density prior to retreatment. Leuprolide must be used in combination with add back therapy (e.g., norethindrone acetate) for

6 months; greater than one retreatment period is not recommended. Leuprolide monotherapy is not recommended for retreatment.

For Zoladex, there is no clinical data on the effect of treatment of benign gynecological conditions with Zoladex for periods in excess of 6 months. Retreatment with Zoladex cannot be recommended for the management of endometriosis.

Endometrial Thinning/Dysfunctional Uterine Bleeding (Zoladex)

Zoladex is proven for endometrial thinning prior to endometrial ablation for dysfunctional uterine bleeding. Zoladex is medically necessary for endometrial thinning when ALL of

the following criteria are met: For use prior to endometrial ablation; and Other causes of symptoms or bleeding are ruled out; and

Patient is to receive Zoladex 3.6mg implant; and Course of therapy is a maximum of two depots. Fertility Preservation

GnRH analogs are proven and medically necessary for the treatment of fertility preservation when ALL of the following criteria are met: Both of the following:



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REVISED


(continued)

Nov. 1, 2017

For use in pre-menopausal women; and Patient is receiving a cytotoxic agent that is associated with causing

primary ovarian insufficiency (premature ovarian failure) [e.g., Cytoxan

(cyclophosphamide), procarbazine, vinblastine, cisplatin]. GnRH therapy should be discontinued upon the completion of treatment.

Uterine Leiomyomata (Fibroids) (Lupron Depot)

Lupron Depot is proven for the treatment of uterine leiomyomata (fibroids). Lupron Depot is medically necessary for the treatment of uterine

leiomyomata when ONE of the following criteria is met: All of the following:

o For the treatment of uterine leiomyomata related anemia; and o Patient did not respond to iron therapy of one month duration; and o For use prior to surgery;

or For use prior to surgery to reduce the size of fibroids to facilitate a

surgical procedure (e.g., myomectomy, hysterectomy). The recommended duration of therapy for the treatment of uterine leiomyomata is ≤ 3 months. Gender Dysphoria in Adolescents

GnRH analogs may be covered for the treatment of Gender Dysphoria when ALL of the following criteria are met:

Submission of medical records (e.g., chart notes, laboratory values) documenting all the following:

o Diagnosis of gender dysphoria, according to the current DSM criteria, by a mental health professional with expertise in child and adolescent psychiatry; and

o One of the following: Medication is prescribed by a pediatric endocrinologist; or

Medication is prescribed by a physician in consultation with a pediatric endocrinologist;

and o Patient has experienced puberty development to at least Tanner

stage 2; and



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REVISED


(continued)

Nov. 1, 2017

o One of the following laboratory tests, based upon the laboratory reference range, confirming: Pubertal levels of estradiol in females; or

Pubertal levels of testosterone in males; and

A letter from the prescriber and/or formal documentation stating all of

the following: o Patient has experienced pubertal changes that have resulted in an

increase of their gender dysphoria that has significantly impaired psychological or social functioning; and

o Coexisting psychiatric and medical comorbidities or social problems, that may interfere with the diagnostic procedures or treatment, have been addressed or removed; and

o Both of the following: Current enrollment, attendance, and active participation in

psychological and social support treatment program; and

Patient will continue enrollment, attendance and active participation in psychological and social support throughout the

course of treatment; and

o Patient demonstrates knowledge and understanding of the expected outcomes of treatment and related transgender therapies.

Note: Clinical evidence supporting the use of GnRH analogs for the treatment of gender dysphoria is limited and lacks long-term safety data. Statistically robust randomized controlled trials are needed to address the issue of whether the benefits outweigh the clinical risk in its use. Disclaimer: This policy does not constitute medical advice. UnitedHealthcare

does not make decisions about the kind of care a member should or should

not receive. Health care professionals are solely responsible for the care they deliver.

Human Menopausal Gonadotropins (hMG)

Nov. 1, 2017

Revised coverage rationale: o Updated list of applicable

human menopausal gonadotropin (hMG) drug agents; removed Repronex®

(menotropins for injection) o Removed language

Oxford has engaged Optum to perform reviews of requests for pre-certification (Oxford continues to be responsible for decisions to limit or deny coverage and for appeals). All authorization/pre-certification requests are handled by Optum. To pre-certify a procedure related to the treatment of infertility, please call Optum at 877-512-9340.

This policy refers to the following hMG agent:



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REVISED


(continued)

Nov. 1, 2017

indicating all hMG agents currently available on the U.S. market are considered

to be therapeutically equivalent

o Updated coverage criteria for

initial and continuation of therapy; replaced criterion requiring “antral follicle count >7” with “antral follicle

count >6” o Removed gender-specific

language; removed and/or replaced references to “females” with “individuals”


for ovulation induction; added language to clarify

gonadotropins are unproven and not medically necessary for the treatment of ovulatory dysfunction in the listed situations

o Updated coverage guidelines for controlled ovarian stimulation: Added language to

clarify gonadotropins are unproven and not

medically necessary for

the treatment of controlled ovarian stimulation in the listed situations

Modified list of unproven/not medically

necessary situations; added “in the setting of very poor/futile

Menopur® (menotropins for injection) The clinically appropriate dosing for hMG when used in an ART cycle without

an FSH product is 450 IU/day or less for not more than 14 days of treatment. The total dose of gonadotropin (hMG and FSH) should not exceed 450 IU per day when used in any mixed stimulation protocol. When used as

part of a mixed stimulation protocol (hMG + FSH) or when used alone for ovulation induction or controlled ovarian stimulation the clinically appropriate maximum dosing for hMG agents is 150 IU/day. Exceeding this daily dose and duration of treatment has not been proven to be efficacious in terms of

pregnancy outcome. hMG agents will be referred to as “gonadotropins” in the following medical necessity language. In absence of a product listed and in addition to applicable criteria outlined

within the drug policy, prescribing and dosing information from the package insert is the clinical information used to determine benefit coverage.

The following information pertains to medical necessity review: General Requirements (applicable to all medical necessity requests):

For initial and continuation of therapy, ALL of the following must be met for consideration of treatment: Prognosis for conception must be ≥ 5%; and

Adequate ovarian reserve as indicated but not limited to at least one the following markers (one or more of the following within the previous 6 months: o FSH level < 15 mIU/ml if > 35 years of age; or

o FSH level < 20 mIU/ml if ≤ 35 years of age; or o AMH level > 0.3 ng/ml; or o Antral follicle count > 6;

and Evidence of adequate ovarian response to stimulation if there has been

previously monitored, medicated-stimulated infertility treatment within the previous 6 months. Examples of adequate ovarian response are: o One follicle ≥ 15 mm diameter for IUI o Minimum of 1 follicle ≥ 15 mm diameter for ART

Diagnosis-Specific Requirements



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(continued)

Nov. 1, 2017

prognosis, defined as a FSH level ≥15 mlU/ml if ≥40 years of age or FSH

level ≥20 mlU/ml if <40 years of age”

Updated supporting information

to reflect the most current FDA information and references

The information below indicates additional requirements for those indications having specific medical necessity criteria in the list of proven indications.

hMG gonadotropins are proven and medically necessary for: Ovulation Induction

Gonadotropins are proven and medically necessary for the treatment of ovulatory dysfunction when ONE of the following criteria are met: Anovulation; or Oligo-ovulation; or All of the following:

o Amenorrhea; and

o Other specific causative factors (e.g., thyroid disease, hyperprolactinemia) have been excluded or treated; and

o Failure to ovulate with either Clomid (clomiphene citrate) or Femara (letrozole);

and

One of the following: o For assisted reproductive technologies (ART), dose does not exceed

450 IU/day, for no more than 14 days per cycle; or o For ovulation induction, dose does not exceed 150 IU/day, for no

more than 14 days per cycle.

Gonadotropins are unproven and not medically necessary for the treatment of ovulatory dysfunction in the following situations:

Beyond the 6th gonadotropin induced ovulatory cycle. When there are ≥ 4 follicles which are ≥15 mm in diameter from a

previously gonadotropin-induced ovulation, despite a dosage adjustment (e.g., doses of gonadotropin down to 37.5 IU per day).

When used alone for individuals with unexplained infertility. When there is a failure to respond to ovulation stimulation (e.g., doses of

gonadotropins up to 225 IU per day and no follicles ≥ 15 mm in

diameter). In lieu of clomiphene or letrozole to correct a thin endometrial lining. An estradiol level <100 pg/ml/follicle ≥15 mm in diameter. Doses that exceed 450 IU/day for ART or 150 IU/day for ovulation

induction, respectively. Duration of therapy that exceeds 14 days per cycle.



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REVISED


(continued)

Nov. 1, 2017

Controlled Ovarian Stimulation

Gonadotropins are proven and medically necessary for the treatment of controlled ovarian stimulation when ALL of the following criteria are met: Used alone or in conjunction with intrauterine insemination; and

One of the following: o Treatment in individuals with diminished ovarian reserve that have

not responded to clomiphene or letrozole; or o Initial treatment for individuals with diminished ovarian reserve; or o Initial treatment for individuals ≥ 40 years of age; or o In the setting of unilateral tubal disease when there is no evidence of

tubal compromise on the patent side when at least 2 cycles of oral

agents (clomiphene or letrozole) have failed to yield a dominant follicle on the side with a patent fallopian tube;


o For assisted reproductive technologies (ART), total gonadotropin

dose does not exceed 450 IU/day, for no more than 14 days per cycle; or

o For controlled ovulation stimulation, dose does not exceed 150 IU/day, for no more than 14 days per cycle.

Gonadotropins are unproven and not medically necessary for the treatment of controlled ovarian stimulation in the following situations:

Treatment in individuals with unexplained infertility, endometriosis, bilateral tubal factor infertility, recurrent pregnancy loss, male factor infertility.

In lieu of clomiphene or letrozole to correct a thin endometrial lining.

When there is a failure to respond to ovarian stimulation, (e.g., doses of gonadotropins up to 225 IU per day and no follicles ≥ 15 mm in diameter).

An estradiol level <100 pg/ml/follicle ≥15 mm in diameter. When there are ≥ 4 follicles which are ≥15 mm in diameter from a

previously gonadotropin-induced ovulation, despite a dosage adjustment. Following ART cycles that fail to result in conception due to poor ovarian

response or poor quality oocytes or embryos. Doses that exceed 450 IU/day for ART or 150 IU/day for controlled

ovulation stimulation, respectively.



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REVISED


(continued)

Nov. 1, 2017 Duration of therapy that exceeds 14 days per cycle. Beyond 4 cycles for individuals age <38, 2 cycles for individuals age 38-

39, and 1 cycle for individuals age 40 and older in the setting ovarian

stimulation for diminished ovarian reserve. In the setting of very poor/futile prognosis, defined as a FSH level ≥15

mlU/ml if ≥40 years of age or FSH level ≥20 mlU/ml if <40 years of age.

Hypogonadotropic Hypogonadism

Gonadotropins are proven and medically necessary for the treatment of hypogonadotropic hypogonadism when ALL of the following criteria are met: One of the following:

o Diagnosis of primary hypogonadotropic hypogonadism; or o Diagnosis of secondary hypogonadotropic hypogonadism; and

For the induction of spermatogenesis; and Infertility is not due to primary testicular failure.

Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion

Nov. 1, 2017

Revised coverage rationale: o Replaced language

indicating: “This guideline addresses

the criteria for consideration of allowing hospital outpatient

facility infusion service for immune globulin (IVIG and SCIG) therapy; this includes hospital based services

with the [listed] CMS/AMA Place of

Service codes” with “this guideline addresses the criteria for consideration of allowing hospital outpatient facility infusion service for

immune globulin (IVIG

Introduction

This guideline addresses the criteria for consideration of allowing hospital outpatient facility infusion service for immune globulin (IVIG and SCIG)

therapy. In accordance with CMS, this includes hospital based services with either of the following Place of Service (POS) codes: 19 (Off-Campus - Outpatient Hospital) 22 (On-Campus - Outpatient Hospital)

Criteria and Clinical Indications for Hospital Outpatient Site of Care Selection

Criteria

Hospital outpatient site of care may be approved when: The patient’s condition meets any of the Clinical Indications below, and The provider has submitted the appropriate supporting documentation

Clinical Indications

Initial infusion of immune globulin, or re-initiation of therapy after more than 6 months off of immune globulin

Change of immune globulin products History of severe adverse events to immune globulin (including but not

limited to anaphylaxis, seizure, thromboembolism, myocardial infarction,



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REVISED

Immune Globulin Site of Care Review Guidelines for

Medical Necessity of Hospital Outpatient Facility

Infusion (continued)

Nov. 1, 2017

and SCIG) therapy; in accordance with CMS, this includes hospital

based services with either of the [listed] Place of Service (POS)

codes” “When requested,

hospital outpatient site of care may be approved

when any of the questions to the Clinical Indications [listed in the policy] can be answered ‘yes’ and the provider has submitted the

appropriate supporting documentation” with

“hospital outpatient site of care may be approved when the patient’s condition meets any of the Clinical Indications

[listed in the policy] and the provider has submitted the appropriate supporting documentation”

o Reformatted and revised list

of clinical indications to

reflect/include: Initial infusion of

immune globulin, or re-initiation of therapy after more than 6 months off of immune globulin

Change of immune globulin products

History of severe

renal failure) Patient is clinically unstable Episodes of moderate to severe adverse events that have not been

responsive to acetaminophen, steroids, diphenhydramine, fluids, infusion rate reductions, or other therapy pre-medications, thereby increasing risk to the patient when administration is in the home or office setting

Patient has immunoglobulin A (IgA) deficiency with anti-IgA antibodies Outpatient treatment in the home or ambulatory setting presents a

health risk due to a clinically significant physical or cognitive impairment

Note: If more than one of the above criteria are met, then the greatest of the applicable approval time periods will be allowed.



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REVISED

Immune Globulin Site of Care Review Guidelines for

Medical Necessity of Hospital Outpatient Facility

Infusion (continued)

Nov. 1, 2017

adverse events to immune globulin (including but not limited

to anaphylaxis, seizure, thromboembolism, myocardial infarction,

renal failure) Patient is clinically

unstable Episodes of moderate to

severe adverse events that have not been responsive to acetaminophen, steroids, diphenhydramine, fluids, infusion rate reductions,

or other therapy pre-medications, thereby

increasing risk to the patient when administration is in the home or office setting

Patient has

immunoglobulin A (IgA) deficiency with anti-IgA antibodies

Outpatient treatment in the home or office setting presents a health

risk due to a clinically

significant physical or cognitive impairment

Added list of applicable Place of Service codes: 19 and 22

Updated supporting information to reflect the most current

clinical evidence and references



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REVISED

Injectable Chemotherapy Drugs: Application

of NCCN Clinical Practice Guidelines

Nov. 1, 2017

Updated list of related policies; added reference link to Clinical Guideline titled Transplant

Review Guidelines: Hematopoietic Stem Cell Transplantation

Updated benefit considerations; added language to indicate: o Chimeric Antigen Receptor

(CAR)-T Cell Therapy may be

eligible for coverage as an autologous stem cell therapy under a member’s Transplantation Services benefit

o Coverage determinations are

based on the OptumHealth Transplant Solutions criteria

for covered transplants; refer to the Clinical Guideline titled Transplant Review Guidelines: Hematopoietic Stem Cell Transplantation

Revised coverage rationale: o Updated description; added

language to indicate: This policy does not

provide coverage criteria for Chimeric Antigen

Receptor (CAR)-T Cell

products Coverage determinations

are based on the member’s benefits and the OptumHealth Transplant Solutions

criteria for covered transplants; refer to the Clinical Guideline titled

Oxford has engaged eviCore healthcare to perform precertification* reviews for injectable chemotherapy drugs administrated by participating providers in an office, outpatient or home setting to treat a cancer diagnosis. Oxford

continues to be responsible for claims payment decisions and for appeals. *Note: Precertification is not required for injectable chemotherapy drugs

administrated by a non-participating provider in an office or outpatient setting however precertification will be provided upon request. All precertification requests for injectable chemotherapy drugs are handled

by eviCore healthcare. To obtain precertification for injectable chemotherapy medications providers must contact CCN. Providers are encouraged to obtain precertification on line by logging in to OxfordHealth.com and selecting the link to the eviCore healthcare authorization web site. Providers may also obtain precertification by calling 1-877-773-2884.

eviCore healthcare uses the National Comprehensive Cancer Network’s (NCCN) guidelines in their decision making process. These guidelines provide

independent recommendations for evidence-based cancer treatment. The guidelines are continually updated to be consistent with the current treatment options. Providers and patients may access and view the NCCN guidelines at NCCN.org. Description

This policy provides parameters for coverage of injectable oncology

medications (J9000-J9999) and select ancillary and supportive care medications used for oncology conditions [including, but not limited to octreotide acetate (J2353 and J2354),leuprolide acetate (J1950), leucovorin (J0640) and levoleucovorin (J0641)] covered under the medical benefit

based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® (NCCN Compendium®). In addition, J0640 and J0641 are included and Q codes as listed below, covered under the medical benefit

based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® (NCCN Compendium®). The Compendium lists the appropriate drugs and biologics for specific cancers using US Food and Drug Administration (FDA)-approved disease indications and specific NCCN panel recommendations. Each recommendation is supported by a level of evidence category. This policy does not provide coverage criteria for Chimeric Antigen Receptor (CAR)-T Cell products. Coverage determinations are based on the

https://www.oxhp.com/ProviderPortal/prepin.controller.do?navId=MYACC_HOME

http://www.nccn.org/



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REVISED


of NCCN Clinical Practice Guidelines (continued)

Nov. 1, 2017

Transplant Review Guidelines: Hematopoietic Stem Cell

Transplantation o Updated guidelines

pertaining to indications and

uses of oncology medications listed in the NCCN Drugs and Biologics Compendium; added language to indicate:

Further review may be indicated if the coverage review using the NCCN Compendium determines that the drug is unproven and the

member has life threatening disease, as

defined or per state mandate; refer to the Benefit Considerations section of the policy for additional guidance

o Removed notation indicating the term “precertification” is also referred to as “prior authorization”; both terms are used and are the same

o Modified additional

information pertaining to

NCCN Guidelines® to indicate: The NCCN Clinical

Practice Guidelines in Oncology (NCCN Guidelines®) are a

comprehensive set of 67 guidelines documenting sequential management

OptumHealth Transplant Solutions criteria for covered transplants; refer to the Clinical Guideline titled Transplant Review Guidelines: Hematopoietic Stem Cell Transplantation.

Coverage Rationale

Injectable Oncology, Ancillary, and Supportive Care Medications

Oxford recognizes indications and uses of oncology medications listed in the

NCCN Drugs and Biologics Compendium with Categories of Evidence and Consensus of 1, 2A, and 2B as proven and medically necessary and Categories of Evidence and Consensus of 3 as unproven and not medically necessary. However, if the coverage review using the NCCN Compendium determines that the drug is unproven and the member has life threatening disease as defined below or per state mandate, further review may be indicated. Please refer to the Benefit Considerations of this policy for

additional guidance. Oxford will cover all chemotherapy agents for individuals under the age of 19

years for oncology indications. The majority of pediatric patients receive treatments on national pediatric protocols that are quite similar in concept to the NCCN patient care guidelines.

Select ancillary and supportive care medications for oncology conditions have therapeutically equivalent products available. When a therapeutically equivalent alternative is available, as determined by the United Healthcare Pharmacy and Therapeutics (P&T) Committee, certain medications may be excluded and/or not medically necessary. For purposes of the United Healthcare P&T Committee review, therapeutic equivalence refers to

medications that can be expected to produce essentially the same therapeutic outcome and adverse events.

Below are ancillary and supportive care medications for oncology conditions with therapeutically equivalent alternatives as determined by the United Healthcare P&T Committee:

Preferred Non-Preferred

Leucovorin Levoleucovorin

Additional Information

The NCCN Clinical Practice Guidelines in Oncology™ (NCCN Guidelines®) are



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REVISED



Nov. 1, 2017

decisions and interventions that apply to malignancies which

apply to more than 97% of cancers affecting U.S. patients; they also

address supportive care issues

The guidelines are developed and updated

by 52 volunteer panels, composed of more than 1,200 clinicians and oncology researchers representing the 27 NCCN Member

Institutions and their affiliates

a comprehensive set of 67 guidelines documenting sequential management decisions and interventions that apply to malignancies which apply to more than 97% of cancers affecting U.S. patients. They also address supportive

care issues. The guidelines are developed and updated by 52 volunteer panels, composed of more than 1,200 clinicians and oncology researchers representing the 27 NCCN member institutions and their affiliates.

NCCN Categories of Evidence and Consensus

Category 1: The recommendation is based on high-level evidence (i.e., high-powered randomized clinical trials or meta-analyses), and the panel has reached uniform consensus that the recommendation is indicated. In this context, uniform means near unanimous positive support with some

possible neutral positions. Category 2A: The recommendation is based on lower level evidence,

but despite the absence of higher level studies, there is uniform consensus that the recommendation is appropriate. Lower level evidence is interpreted broadly, and runs the gamut from phase II to large cohort

studies to case series to individual practitioner experience. Importantly, in many instances, the retrospective studies are derived from clinical

experience of treating large numbers of patients at a member institution, so panel members have first-hand knowledge of the data. Inevitably, some recommendations must address clinical situations for which limited or no data exist. In these instances the congruence of experience-based opinions provides an informed if not confirmed direction for optimizing patient care. These recommendations carry the implicit recognition that

they may be superseded as higher level evidence becomes available or as outcomes-based information becomes more prevalent.

Category 2B: The recommendation is based on lower level evidence, and there is nonuniform consensus that the recommendation should be

made. In these instances, because the evidence is not conclusive, institutions take different approaches to the management of a particular clinical scenario. This nonuniform consensus does not represent a major

disagreement rather it recognizes that given imperfect information, institutions may adopt different approaches. A Category 2B designation should signal to the user that more than one approach can be inferred from the existing data.

Category 3: The recommendation has engendered a major disagreement among the panel members. Several circumstances can cause major disagreements. For example, if substantial data exists about



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REVISED



Nov. 1, 2017 two interventions but they have never been directly compared in a randomized trial, adherents to one set of data may not accept the interpretation of the other side's results. Another situation resulting in a

Category 3 designation is when experts disagree about how trial data can be generalized. A Category 3 designation alerts users to a major interpretation issue in the data and directs them to the manuscript for an

explanation of the controversy. If the drug regimen being requested does not have a NCCN 1, 2a, or 2b NCCN Guideline recommendation, refer to the following Oxford policies:

Clinical Trials Experimental/Investigational Treatment Experimental/Investigational Treatment for NJ Plans Facilities, physicians and other health care professionals are encouraged to utilize the most appropriate ICD-10-CM diagnosis codes in accordance with

applicable code set guidelines.

Maximum Dosage Policy

Nov. 1, 2017

Added reference links to related policies titled: o Entyvio® (Vedolizumab) o Soliris® (Eculizumab) o White Blood Cell Colony

Stimulating Factors

o Xolair® (Omalizumab) Revised coverage rationale:

o Updated list of applicable drug products; added: Eculizumab (Soliris®) Infliximab-abda

(Renflexis™)

Omalizumab (Xolair®) Vedolizumab (Entyvio®)

o Added HCPCS code based maximum dosage information for: Entyvio (vedolizumab)

- Maximum Dosage

per Administration: 300 mg

Refer to the policy for complete details on Maximum Dosage guidelines.



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REVISED

Maximum Dosage Policy (continued)

Nov. 1, 2017

- HCPCS code: J3380 - Maximum Allowed:

300 HCPCS units

(1mg per unit) Renflexis (infliximab-

abda)

- Maximum Dosage per Administration: 10 mg/kg

- HCPCS code: Q5102

- Maximum Allowed: 119 HCPCS units (10 mg per unit)

Soliris (eculizumab) - Diagnosis: PNH

Maximum

Dosage per Administration:

900mg HCPCS code:

J1300 Maximum

Allowed: 90

HCPCS units (10 mg per unit)

- Diagnosis: aHUS, MG Maximum

Dosage per Administration:

1200 mg

HCPCS code: J1300

Maximum Allowed: 120 HCPCS units (10 mg per unit)

Stelara (ustekinumab) - Diagnosis: Crohn’s

Disease



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REVISED


Nov. 1, 2017

- Maximum Dosage per Administration: 520 mg

- HCPCS Code: Q9989 - Maximum Allowed:

520 HCPCS units (1

mg per unit) Xolair (omalizumab)

- Diagnosis: Asthma Maximum

Dosage per Administration: 375 mg

HCPCS code: J2357

Maximum

Allowed: 90 HCPCS units (5

mg per unit) - Diagnosis: Chronic

Urticaria Maximum

Dosage per

Administration: 300 mg

HCPCS code: J2357

Maximum Allowed: 60

HCPCS units (5

mg per unit) o Added maximum allowed

quantities for National Drug Code (NDC) billing for: Entyvio (vedolizumab)

- How Supplied: 300

mg powder for reconstitution

- National Drug Code:



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REVISED


Nov. 1, 2017

64764-0300-20 - Maximum Allowed: 1

Vial

Renflexis (infliximab-abda) - How Supplied: 100

mg powder for reconstitution

- National Drug Code: 00006-4305-02

- Maximum Allowed: 12 vials

Soliris (eculizumab) - Diagnosis: PNH

How Supplied: 300 mg/30 mL

solution in vials National Drug

Code: 25682-0001-01

Maximum Allowed: 3 vials

- Diagnosis: aHUS, MG

How Supplied: 300 mg/30 mL solution in vials

National Drug Code: 25682-0001-01

Maximum

Allowed: 4 vials Stelara (ustekinumab)

- Diagnosis: Crohn’s Disease

- How Supplied: 130 mg/26 mL solution in

vials - National Drug Code:

57894-0054-27



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REVISED


Nov. 1, 2017 - Maximum Allowed: 104 mL

Xolair (omalizumab)

- Diagnosis: Asthma How Supplied:

150 mg powder

for reconstitution National Drug

Code: 50242-0040-62


- Diagnosis: Chronic Urticaria How Supplied:

150 mg powder

for reconstitution National Drug

Code: 50242-0040-62


o Removed language

indicating maximum allowed quantity information applies only to select providers billing medical claims by NDC

Updated list of applicable HCPCS

codes; added J1300, J2357,

J3380, and Q9989 Updated list of applicable NDCs;

added 64764-0300-20, 00006-4305-02, 25682-0001-01, 57894-0054-27, and 50242-0040-62

Updated supporting information to reflect the most current references



Oxford


REVISED

OcrevusTM (Ocrelizumab)

Nov. 1, 2017

Revised coverage rationale: o Replaced language indicating

“Ocrelizumab is proven and

medically necessary for the treatment of primary progressive multiple

sclerosis and relapsing forms of multiple sclerosis when [the listed] criteria are met” with “Ocrevus is proven and

medically necessary for the treatment of primary progressive multiple sclerosis and relapsing forms of multiple sclerosis when [the listed] criteria are met”

o Added medical necessity criteria for the treatment of:

Primary progressive multiple sclerosis (PPMS)

when all of the following criteria are met: Diagnosis of primary

progressive multiple sclerosis (PPMS); and

One of the following:

Initial therapy for ocrelizumab when meeting both of the

following: o Patient is not

receiving ocrelizumab in

combination with any of the following: Disease

modifying therapy (e.g., interferon beta

Please refer to the policy titled Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines for updated information based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics

Compendium® (NCCN Compendium®) for oncology indications. Ocrevus (ocrelizumab) is proven and medically necessary for:

I. Primary Progressive Multiple Sclerosis

Ocrevus is medically necessary for the treatment of primary progressive multiple sclerosis (PPMS) when ALL of the following criteria are met: Diagnosis of primary progressive multiple sclerosis (PPMS); and

One of the following: o Initial therapy for ocrelizumab when meeting both of the

following: Patient is not receiving ocrelizumab in combination with any

of the following:

- Disease modifying therapy (e.g., interferon beta preparations, daclizumab, dimethyl fumarate, glatiramer

acetate, natalizumab, fingolimod, or teriflunomide) - B cell targeted therapy (e.g., rituximab, belimumab,

ofatumumab) - Lymphocyte trafficking blockers (e.g., alemtuzumab,

mitoxantrone) and

Initial dosing: One time 300 mg intravenous course of doses on days 1 and 15.

or o Continuation therapy for ocrelizumab when meeting all of the

following: Patient has previously received treatment with ocrelizumab;

and

Documentation of positive clinical response to ocrelizumab therapy; and

Patient is not receiving ocrelizumab in combination with any of the following: - Disease modifying therapy (e.g., interferon beta

preparations, daclizumab, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, or teriflunomide)



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REVISED

OcrevusTM (Ocrelizumab) (continued)

Nov. 1, 2017

preparations, daclizumab, dimethyl

fumarate, glatiramer acetate,

natalizumab, fingolimod, or teriflunomide)

B cell targeted

therapy (e.g., rituximab, belimumab, ofatumumab)

Lymphocyte trafficking

blockers (e.g., alemtuzumab,

mitoxantrone) and

o Initial dosing: One time 300 mg intravenous course

of doses on days 1 and 15

or Continuation therapy for ocrelizumab when meeting all of the

following:

o Patient has previously received treatment with ocrelizumab; and

o Documentation of positive clinical

response to ocrelizumab therapy; and

- B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)

- Lymphocyte trafficking blockers (e.g., alemtuzumab,

mitoxantrone) and

Continued dosing: One 600 mg intravenous dose every 6

months. II. Relapsing Forms of Multiple Sclerosis

Ocrevus is medically necessary for the treatment of relapsing forms of multiple sclerosis (MS) when BOTH of the following criteria are met:

Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses); and

One of the following: o Initial therapy for ocrelizumab meeting all of the following:

Patient has history of failure following a trial for at least 4 weeks or history of intolerance or contraindication to one of

the following: - interferon β-1a (Avonex®, Rebif®, Plegridy™) - interferon β-1b (Betaseron® or Extavia®) - glatiramer acetate (Copaxone®) - dimethyl fumarate (Tecfidera®) - teriflunomide (Aubagio®)

- fingolimod (Gilenya®) - alemtuzumab (Lemtrada®) - natalizumab (Tysabri®) - daclizumab (Zinbryta™)

and Patient is not receiving ocrelizumab in combination with any

of the following:

- Disease modifying therapy (e.g., interferon beta preparations, daclizumab, glatiramer acetate, natalizumab, fingolimod, or teriflunomide)

- B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)

- Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone)



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REVISED


Nov. 1, 2017

o Patient is not receiving ocrelizumab in

combination with any of the following: Disease

modifying therapy (e.g., interferon beta preparations,

daclizumab, dimethyl fumarate, glatiramer acetate, natalizumab,

fingolimod, or teriflunomide)

B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)

Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone)

and

o Continued dosing:

One 600 mg intravenous dose every 6 months

Relapsing forms of

multiple sclerosis (MS) when both of the following criteria are met: Diagnosis of relapsing

forms of multiple

and Initial dosing: One time 300 mg intravenous course of doses

on days 1 and 15.

or o Continuation therapy for ocrelizumab when meeting all of the

following:

Patient has previously received treatment with ocrelizumab; and

Documentation of positive clinical response to ocrelizumab therapy; and

Patient is not receiving ocrelizumab in combination with any of the following: - Disease modifying therapy (e.g., interferon beta

preparations, daclizumab, dimethyl fumarate, glatiramer acetate, natalizumab, fingolimod, or teriflunomide)

- B cell targeted therapy (e.g., rituximab, belimumab,

ofatumumab) - Lymphocyte trafficking blockers (e.g., alemtuzumab,

mitoxantrone) and

Continued dosing: One 600 mg intravenous dose every 6 months.

Ocrevus is unproven and not medically necessary for the treatment of: Lupus nephritis Rheumatoid arthritis Systemic lupus erythematosus



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REVISED


Nov. 1, 2017

sclerosis (MS) (e.g., relapsing-remitting MS, secondary-progressive

MS with relapses, progressive-relapsing MS with relapses); and

One of the following: Initial therapy for ocrelizumab meeting all of the following:

o Patient has history of failure following a trial for at least 4 weeks or history of intolerance or contraindication to

one of the following: interferon β-1a

(Avonex®, Rebif®, Plegridy™)

interferon β-1b (Betaseron® or

Extavia®) glatiramer

acetate (Copaxone®)

dimethyl fumarate

(Tecfidera®)

teriflunomide (Aubagio®)

fingolimod (Gilenya®)

alemtuzumab (Lemtrada®)

natalizumab (Tysabri®)

daclizumab



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REVISED


Nov. 1, 2017

(Zinbryta™) and

o Patient is not

receiving ocrelizumab in combination with any

of the following: Disease

modifying therapy (e.g.,

interferon beta preparations, daclizumab, glatiramer acetate, natalizumab,

fingolimod, or teriflunomide)

B cell targeted therapy (e.g., rituximab, belimumab, ofatumumab)

Lymphocyte trafficking blockers (e.g., alemtuzumab, mitoxantrone) and

o Initial dosing: One

time 300 mg intravenous course of doses on days 1 and 15 or

Continuation therapy

for ocrelizumab when meeting all of the following:



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REVISED


Nov. 1, 2017

o Patient has previously received treatment with

ocrelizumab; and o Documentation of

positive clinical

response to ocrelizumab therapy; and

o Patient is not

receiving ocrelizumab in combination with any of the following: Disease

modifying

therapy (e.g., interferon beta

preparations, daclizumab, dimethyl fumarate, glatiramer

acetate, natalizumab, fingolimod, or teriflunomide)

B cell targeted therapy (e.g.,

rituximab,

belimumab, ofatumumab)

Lymphocyte trafficking blockers (e.g., alemtuzumab,

mitoxantrone) and

o Continued dosing:



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REVISED


Nov. 1, 2017

One 600 mg intravenous dose every 6 months

o Replaced language indicating “ocrelizumab is unproven and not medically necessary

for the treatment of lupus nephritis, rheumatoid arthritis, and systemic lupus erythematosus” with

“Ocrevus is unproven and not medically necessary for the treatment of lupus nephritis, rheumatoid arthritis, and systemic lupus erythematosus”

Updated supporting information to reflect the most current

clinical evidence, FDA information, and references

Orencia® (Abatacept) Injection for

Intravenous Infusion

Nov. 1, 2017

Revised coverage rationale: o Added language to indicate

Orencia is proven and

medically necessary for the treatment of psoriatic arthritis when all of the following criteria are met: Diagnosis of active

psoriatic arthritis (PsA);

and

Orencia is initiated and titrated according to U.S. Food and Drug Administration labeled dosing for psoriatic arthritis up to a maximum of (or

equivalent dose and interval schedule):

This policy refers to Orencia (abatacept) injection for intravenous infusion. Orencia is proven and medically necessary for the treatment of:

Polyarticular juvenile idiopathic arthritis when all of the following criteria are met: o Diagnosis of moderately to severely active polyarticular juvenile

idiopathic arthritis (PJIA); and o Orencia is initiated and titrated according to US Food and Drug

Administration labeled dosing for polyarticular juvenile idiopathic arthritis up to a maximum of (or equivalent dose and interval schedule): 10mg/kg every 4 weeks for patients weighing <75kg 1,000mg every 4 weeks for patients weighing ≥75kg and

o Member is not receiving Orencia in combination with either of the following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g.,

Enbrel (etanercept), Humira (adalimumab), Cimzia



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REVISED


Intravenous Infusion (continued)

Nov. 1, 2017

- 500mg every 4 weeks for patients weighing <60kg

- 750mg every 4 weeks for patients weighing 60kg to

100kg - 1,000mg every 4

weeks for patients weighing >100kg

and Patient is not receiving

Orencia in combination with any of the following: - Biologic DMARD

[e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

- Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

- Phosphodiesterase 4 (PDE4) inhibitor [e.g. Otezla (apremilast)]

o Removed language

indicating Orencia is unproven and not medically necessary for the treatment of psoriatic arthropathy

Updated list of applicable ICD-10 diagnosis codes; added L40.50,

L40.51, L40.52, L40.53, L40.54, and L40.59


(certolizumab), Simponi (golimumab)] Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

Rheumatoid arthritis when all of the following criteria are met: o Diagnosis of moderately to severely active rheumatoid arthritis; and o Orencia is initiated and titrated according to US Food and Drug

Administration labeled dosing for rheumatoid arthritis up to a maximum of (or equivalent dose and interval schedule):

500mg every 4 weeks for patients weighing <60kg 750mg every 4 weeks for patients weighing 60kg to 100kg 1,000mg every 4 weeks for patients weighing >100kg and

o Member is not receiving Orencia in combination with either of the following: Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)] Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

Psoriatic arthritis when all of the following criteria are met:

o Diagnosis of active psoriatic arthritis (PsA); and

o Orencia is initiated and titrated according to US Food and Drug Administration labeled dosing for psoriatic arthritis up to a maximum of (or equivalent dose and interval schedule): 500mg every 4 weeks for patients weighing <60kg 750mg every 4 weeks for patients weighing 60kg to 100kg 1,000mg every 4 weeks for patients weighing >100kg and

o Patient is not receiving Orencia in combination with any of the following: Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

Orencia is unproven and not medically necessary for the treatment of: Multiple sclerosis Systemic lupus erythematosus Graft versus host disease (GVHD) Uveitis associated with Behçet's disease



Oxford


REVISED


Intravenous Infusion (continued)

Nov. 1, 2017 to reflect the most current background information, clinical evidence, FDA information, and

references

Panniculectomy and Body

Contouring Procedures

Nov. 1, 2017

Revised coverage rationale: o Clarified coverage criteria for

panniculectomy: Replaced criterion

requiring “there is a presence of a functional impairment due to the panniculus” and “the

panniculus is interfering with activities of daily

living” with “there is presence of a functional impairment (interference with activities of daily living) due to the

panniculus” o Clarified notation pertaining

to panniculectomy following weight loss: Replaced language

indicating “after significant weight loss

not following bariatric surgery, in addition to the criteria listed, there must be documentation that a stable weight has been maintained for six

months” with “after significant weight loss unrelated to bariatric surgery, in addition to

Indications for Coverage

Panniculectomy

Panniculectomy is considered reconstructive and medically necessary when ALL of the following criteria have been met: Panniculus must hang below symphysis pubis; The panniculus is the primary cause of skin conditions when present,

such a cellulitis requiring systemic antibiotics or transdermal skin ulcerations that require medical treatment;

There is presence of a functional impairment (interference with activities of daily living) due to the panniculus;

The surgery is expected to restore or improve the functional impairment. Note:

After significant weight loss unrelated to bariatric surgery, in addition to the criteria listed above, there must be documentation that a stable weight has been maintained for six months.

After significant weight loss following bariatric surgery, in addition to meeting the criteria listed above, there must be documentation that a stable weight has been maintained for six months. This often occurs 12-

18 months after surgery. Panniculectomy is not considered reconstructive or medically

necessary, in the following situations (not an all-inclusive list): When performed to relieve neck or back pain as there is no evidence that

reduction of redundant skin and tissue results in less spinal stress or improved posture/alignment.

When performed in conjunction with abdominal or gynecologic surgery including but not limited to hernia repair, obesity surgery, C-section and hysterectomy unless the member meets the criteria for panniculectomy as stated above in this document.

Performed post childbirth in order to return to pre pregnancy shape. Performed for intertrigo, a superficial inflammatory response or any other



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REVISED

Panniculectomy and Body Contouring

Procedures (continued)

Nov. 1, 2017 the criteria listed, there must be documentation that a stable weight has

been maintained for six months”

o Added language to indicate

repair of diastasis recti is considered a cosmetic procedure and is not a covered service

Updated definitions: o Added language to indicate

the definitions listed in the policy may not apply to all plans; refer to the member specific benefit plan

document for applicable definitions

o Added definition of “diastasis recti”

Updated supporting information to reflect the most current references

condition that does not meet the criteria above in this document. Documentation may be requested as part of the review, including but not

limited to photographs and physician office notes. Abdominoplasty

Abdominoplasty is not considered reconstructive or medically necessary. Repair of diastasis recti is considered a cosmetic procedure, and is not a covered service. Lipectomy

Lipectomy is not considered reconstructive or medically necessary, in the following situation (not an all-inclusive list): Performed on any site including buttocks, arms, legs, neck, abdomen and

medial thigh. Suction-Assisted Lipectomy of the Trunk

Suction-assisted lipectomy of the trunk (CPT code 15877) is not considered reconstructive (unless part of an approved procedure) or medically necessary. For post-mastectomy patients, please refer to the policy titled Breast Reconstruction Post Mastectomy. Coverage Limitations and Exclusions

Some states require benefit coverage for services that Oxford Health Plans

considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to the member specific benefit plan document. Cosmetic Procedures are excluded from coverage. Procedures that

correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially

avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or behavior) as a reconstructive procedure.

Any procedure that does not meet the reconstructive criteria above in the Indications for Coverage section of the policy.



Oxford


REVISED

Preventive Care Services

Oct. 1, 2017

Notice of Revision: The following summary of changes has been modified. Implementation of the

revisions noted in red below has been delayed until further notice; complete details will be provided in a

future edition of the Policy Update Bulletin. Updated coverage rationale/

indications for coverage:

Pediatrics

o Clarified list of services covered under the preventive care benefit for children (of the appropriate age); replaced “counseling

for fluoride for prevention of dental cavities” with

“application of fluoride by a primary care provider for prevention of dental cavities”

Added language to indicate the definitions listed in the policy may not apply to all plans; refer

to the member specific benefit plan document for applicable definitions

Revised list of applicable

procedure and diagnosis codes for:

Preventive Care Services

Chlamydia Infection Screening

o Added notation to indicate Bright Futures recommends sexually transmitted infection screening if risk

assessment is positive between age 11–21 years

Refer to the policy for complete details on the coverage guidelines for Preventive Care Services.



Oxford


REVISED

Preventive Care Services (continued)

Oct. 1, 2017

Gonorrhea Screening

o Added notation to indicate Bright Futures recommends sexually transmitted infection screening if risk assessment is positive

between age 11–21 years

HIV – Human Immunodeficiency Virus – Screening for Adolescents and Adults

o Added notation to indicate Bright Futures recommends HIV screening lab work: Once between age 15–

18 years Anytime between age

11–14 years and 19–21

years if risk assessment is positive

Cholesterol Screening (Lipid

Disorders Screening) o Added instruction to refer to

the Dyslipidemia Screening (Bright Futures) section of the policy for recommendations for

children

Colorectal Cancer Screening o Updated list of applicable

procedure codes for fecal

occult blood testing (FOBT), fecal immunochemical test (FIT), fecal DNA, sigmoidoscopy, or colonoscopy: Modified Code Group 5

for pre-op/consultation; removed CPT codes 99241, 99242, 99243,



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REVISED


Oct. 1, 2017

99244, and 99245

Newborn Screenings

o Added instruction to refer to the Hearing Tests (Bright Futures) section of the policy for information on hearing

screening for newborns

Screening and Behavioral Counseling Interventions in Primary Care to Reduce Alcohol

Misuse o Removed/replaced notation

indicating the Bright Futures Periodicity Schedule recommends alcohol use assessment begin at age 11;

added to indicate Bright

Futures (April 2017) recommends alcohol or drug use assessments from age 11 years–21 years

o Reformatted list of applicable procedure codes; added

code classification/sub-heading for: Alcohol or drug use

screening (CPT codes 99408 and 99409)

Annual alcohol screening

(HCPCS code G0442)

Brief counseling for alcohol (HCPCS code G0443)

Depression in Children and

Adolescents (Screening) o Replaced notation indicating

“the Bright Futures Periodicity Schedule recommends depression



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REVISED


Oct. 1, 2017

screening begin at age 12” with “the Bright Futures Periodicity Schedule

recommends depression screening begin at age 12 through 21 years”

Primary Care Interventions to

Prevent Tobacco Use in Children and Adolescents o Added notation to indicate

Bright Futures (April 2017) recommends tobacco use assessments from age 11–

21 years o Reformatted list of applicable

procedure codes; added code classification/sub-

heading for “smoking and tobacco use cessation counseling visit” (CPT codes

99401, 99402, 99403, 99404, 99406, and 99407)

Preeclampsia Screening (new to

policy) o Added language to indicate:

The USPSTF recommends screening for preeclampsia in pregnant women with

blood pressure

measurements throughout pregnancy (USPSTF Rating: B)

Preeclampsia screening by blood pressure measurement is included

in the code for a wellness examination visit; see the Wellness



Oxford


REVISED


Oct. 1, 2017

Examinations section of the policy for applicable procedure codes and

preventive benefit instructions

Bright Futures

Hearing Tests o Added language to indicate

Bright Futures (April 2017)

recommends: Hearing test:

- At age newborn, between 3-5 days to 2 months, 4 years, 5 years, 6 years, 8

years, 10 years, once between 11–14

years, once between 15–17 years, and once between 18–21 years

- If risk assessment is

positive Risk assessment:

- At age 4 months, 6 months, 9 months, 12 months, 15 months, 18 months, 24 months, 30

months, 3 years, 7 years, and 9 years

o Updated and reformatted list of applicable procedure codes: Added code

classification/sub-heading for “hearing tests” (CPT codes 92551, 92552, and 92553)



Oxford


REVISED


Oct. 1, 2017

Added notation to indicate a risk assessment is included

in the code for a wellness examination visit; see the Wellness

Examinations section of the policy for applicable procedure codes

Dyslipidemia Screening

o Added language to indicate Bright Futures (April 2017) recommends:

Risk assessment: - At age 24 months, 4

years, 6 years, 8 years, 12 years, 13

years, 14 years, 15 years, and 16 years

Lab work:

- If risk assessment is positive; or

- Once between age 9–11 years and once between age 17–21 years

o Updated and reformatted list of applicable procedure codes:

Modified code classification/sub-heading; replaced “dyslipidemia screening”

with “dyslipidemia screening lab work”

Added notation to indicate a risk assessment is included in the code for a



Oxford


REVISED


Oct. 1, 2017

wellness examination visit; see the Wellness Examinations section of

the policy for applicable procedure codes

Tobacco, Alcohol or Drug Use

Assessment (new to policy) o Added language to indicate

Bright Futures (April 2017) recommends tobacco, alcohol or drug use assessment from age 11 years–21 years

o Added instruction to see the following sections of the policy for applicable procedure codes and

preventive benefit instructions: Primary Care

Interventions To Prevent Tobacco Use in Children and Adolescents and Screening

Behavioral Counseling Interventions in Primary

Care to Reduce Alcohol Misuse

Psychosocial/Behavioral

Assessment Bright Futures (new

to policy) o Added language to indicate:

Bright Futures (April 2017) recommends psychosocial/behavioral assessment at each of

the recommended visits between age newborn–21 years



Oxford


REVISED


Oct. 1, 2017

An assessment is included in the procedure code for a

wellness examination visit

o Added instruction to see the

Wellness Examinations section of the policy for applicable procedure codes and preventive benefit

instructions

Depression Screening (new to policy)

o Added language to indicate Bright Futures (April 2017) recommends depression screening at each of the

recommended visits between age 12 years–21 years

o Added instruction to see the

Depression in Children and Adolescents (Screening) section of the policy for applicable procedure codes and preventive benefit instructions

Sexually Transmitted Infections (STI) (new to policy) o Added language to indicate

Bright Futures (April 2017)

recommends: Risk assessment:

- At each of the recommended visits between age 11–21 years

Lab work: - If risk assessment is

positive



Oxford


REVISED


Oct. 1, 2017

o Added instruction to see the following sections of the policy for applicable

procedure codes and preventive benefit instructions:

Chlamydia Infection Screening

Gonorrhea Screening

HIV Screening (new to policy)

o Added language to indicate Bright Futures (April 2017) recommends:

Risk assessment: - At age 11 years, 12

years, 13 years, 14 years, 19 years, 20

years, and 21 years Lab work:

- Once between age

15–18 years - Anytime between

age 11–14 years and 19–21 years when risk assessment is positive

o Added instruction to see the HIV – Human Immunodeficiency Virus –

Screening for Adolescents and Adults section of the policy for applicable procedure codes and

preventive benefit instructions

Expanded Women’s

Preventive Health

Breastfeeding Support, Supplies, and Counseling



Oxford


REVISED


Oct. 1, 2017

o Updated list of applicable procedure codes for support and counseling; removed

CPT codes 99241, 99242, 99243, 99244, and 99245

Pregnancy Diagnosis Code

List o Updated list of applicable

ICD-10 diagnosis codes to reflect annual code edits: Added O00.101,

O00.102, O00.109,

O00.111, O00.112, O00.119, O00.201, O00.202, O00.209, O00.211, O00.212, O00.219, O36.8310,

O36.8311, O36.8312, O36.8313, O36.8314,

O36.8315, O36.8319, O36.8320, O36.8321, O36.8322, O36.8323, O36.8324, O36.8325, O36.8329, O36.8330, O36.8331, O36.8332,

O36.8333, O36.8334, O36.8335, O36.8339, O36.8390, O36.8391, O36.8392, O36.8393,

O36.8394, O36.8395, O36.8399, Z36.0, Z36.1, Z36.2, Z36.3, Z36.4,

Z36.5, Z36.81, Z36.82, Z36.83, Z36.84, Z36.85, Z36.86, Z36.87, Z36.88, Z36.89, Z36.8A, and Z36.9

Removed O00.10, O00.11, O00.20,



Oxford


REVISED


Oct. 1, 2017

O00.21, and Z36

Diabetes Diagnosis Code List

o Updated list of applicable ICD-10 diagnosis codes to reflect annual code edits;

added E11.10 and E11.11

Sodium Hyaluronate

Nov. 1, 2017

Replaced references to “Genvisc 850” and “Gen-Visc 850” with “GenVisc 850”

Revised conditions of coverage/precertification requirements:

o Updated list of procedure codes requiring review by a medical director or their designee in all sites of service:

Added J7320, J7322, and J7327

Removed Q9980 o Updated list of procedure

codes for which precertification is not required in the office setting: Added 20606 and 20611 Removed “outpatient”

from list of applicable settings

Updated coverage rationale:

o Removed language pertaining to precertification requirements in the office

setting (refer to Conditions of Coverage section of the policy)

o Updated coverage guidelines for treatment of osteoarthritis of the knee;

Initial Course of Administration/Treatment

Intra-articular injections of sodium hyaluronate are proven and

medically necessary for treating pain due to osteoarthritis of the knee when administered according to U.S. Food and Drug Administration (FDA) labeled indications.

FDA Labeling*

Euflexxa 3 injections

Gel One 1 injection

Gel-Syn 3 injections

GenVisc 850 3 to 5 injections

Hyalgan 5 injections

Hymovis 2 injections

Monovisc 1 injection

Orthovisc 3 to 4 injections

Supartz 3 to 5 injections

Synvisc 3 injections

Synvisc One 1 injection

*Hyaluronic acid preparations for the treatment of pain due to osteoarthritis

of the knee are deemed therapeutically equivalent. The UnitedHealth Group National Pharmacy and Therapeutics Committee has defined therapeutically equivalent, products that can be expected to produce essentially the same therapeutic outcome and toxicity.

Note: There is no evidence that use of one intra-articular hyaluronan product is superior to another. Euflexxa, and Synvisc or Synvisc-One (J7323, J7325)

Pre-certification is not required in the office for J7323 and J7325.



Oxford


REVISED

Sodium Hyaluronate (continued)

Nov. 1, 2017

modified medical necessity criteria for intra-articular hyaluronan injections:

Updated procedure code listings for injectable medications; replaced:

- “Monovisc (J3490)” with “Monovisc (J7327)”

- “GenVisc 850

(Q9980)” with “GenVisc 850 (J7320)”

- “Hymovis (J3490)” with “Hymovis (J7322)”

Updated list of procedure codes for which

precertification is required in all settings: - Added J7320, J7322,

and J7327 - Removed Q9980

Removed list of applicable ICD-10 procedure codes: 3E0U33Z, 3E0U3GC, 3E0U36Z, 3E0U37Z, 3E0U3SF, 3E0U3BZ, 3E0U3HZ, 3E0U3KZ, 3E0U3NZ, and 3E0U3TZ

Intra-articular hyaluronan injections, Euflexxa (1% sodium

hyaluronate), and Synvisc (Hylan G-F 20) or Synvisc-One (Hylan G-F 20), are proven and medically necessary for members with osteoarthritis of the knee who meet all of the following criteria: The member has documented symptomatic osteoarthritis of the knee;

The member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing);

The member has not responded adequately to conservative therapy

which may include physical therapy or pharmacotherapy (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen and/or topical capsaicin cream) or injection of intra-articular steroids and such therapy has not resulted in functional improvement after at least 3 months, or the member is unable to tolerate conservative therapy because of adverse side effects;

The pain cannot be attributed to other forms of joint disease; and

There are no contraindications to the injections (e.g., active joint infection, bleeding disorder).

Hyalgan and Supartz (J7321), Orthovisc (J7324), Gel-One (J7326), Monovisc (J7327), Gel-Syn (J7328), GenVisc 850 (J7320), and Hymovis (J7322)

Pre-certification is required in all settings for J7320, J7321, J7322, J7324, J7326, J7327, J7328 and J3490.

Intra-articular hyaluronan injections, Hyalgan (sodium hyaluronate) and Supartz (sodium hyaluronate), Orthovisc (high molecular weight form of hyaluronic acid), Gel-One (hyaluronan), Monovisc (cross-linked sodium hyaluronate), Gel-Syn (sodium hyaluronate), GenVisc 850 (sodium hyaluronate), and Hymovis (hyaluronic acid) are proven

and medically necessary for members with osteoarthritis of the knee

who have met the criteria above and: The member has a history of failure, contraindication or intolerance

documented trial and failure to Synvisc, Synvisc-One or Euflexxa. Intra-articular injections of sodium hyaluronate are proven and medically necessary for treating temporomandibular joint (TMJ) disc displacement and osteoarthritis.

Sodium hyaluronate preparations are unproven and not medically necessary for treating any other indication not listed above as



Oxford


REVISED

Sodium Hyaluronate (continued)

Nov. 1, 2017

medically necessary including but not limited to: Pain due to osteoarthritis in any joint other than the knee or TMJ Any other form of arthritis [including rheumatoid arthritis (RA)]

Patello-femoral syndrome Chondromalacia of the knee Following total or partial knee joint replacement

Increase in viscoelasticity of synovial fluid after sodium hyaluronate injection has not been demonstrated in patients with rheumatoid arthritis, and it has not been determined whether sodium hyaluronate is protective in joints affected by rheumatoid arthritis. Further studies are needed to determine the safety and durability of such treatment for patello-femoral syndrome and

chondromalacia of the knee and whether it significantly delays the need for more invasive treatment, e.g., surgery, joint replacement or arthroplasty. There are no clinical studies evaluating the use of sodium hyaluronate in persons following total or partial knee joint replacement surgery. Hyaluronic acid gel preparations to improve the skin's contour

and/or reduce depressions due to acne, scars, injury or wrinkles are

considered cosmetic. The use of sodium hyaluronate preparations to improve the skin's contour and/or reduce depressions in the skin due to acne, scars, injury or wrinkles improves physical appearance but does not remove or improve a functional impairment of the skin. Subsequent Course of Administration/Treatment

Repeated courses of intra-articular sodium hyaluronan injections of the knee may be considered proven and medically necessary under

the following conditions: Documentation of significant pain relief achieved with the prior course of

injections; and Pain has recurred; and At least six (6) months have passed since the prior course of treatment.



Oxford


REVISED

Temporo-mandibular Joint Disorders

Oct. 1, 2017

Notice of Revision: The following summary of changes has been modified. Implementation of the

revision noted in red below has been delayed until further notice; complete details will be provided in a

future edition of the Policy Update Bulletin. Revised benefit considerations;

removed “consultations” from list of services eligible for coverage

Updated supporting information to reflect the most current FDA information

The following services are proven and medically necessary for treating disorders of the temporomandibular joint (TMJ): Arthrocentesis

Arthroplasty [For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Temporomandibular Joint Arthroplasty, ACG: A-0523 (AC)]

Arthroscopy (with or without FDA approved bone anchor devices) Arthrotomy/open joint surgery (with or without FDA approved bone

anchor devices) Injections of corticosteroids for rheumatoid arthritis-related TMJ

disorders Physical therapy Stabilization and repositioning splint therapy (does not include low-load

prolonged-duration stretch (LLPS) devices discussed below) Partial or total joint replacement with an artificial prosthesis is

proven and medically necessary for treating disorders of the Temporomandibular Joint (TMJ) when all other treatments have

failed. Not all services treat all TMJ disorders; specific treatments are based upon the specific diagnosis. The following services are unproven and not medically necessary for

treating disorders of the temporomandibular joint (TMJ): Biofeedback Craniosacral manipulation Passive rehabilitation therapy Low-load prolonged-duration stretch (LLPS) devices

There are limited studies evaluating biofeedback for the treatment of

musculoskeletal pain, including TMJ pain. One small uncontrolled study

reported positive effects, while a larger randomized controlled study failed to demonstrate any treatment effect.

Well-designed randomized, blinded and placebo-controlled outcome studies published on craniosacral manipulation for TMJ are not available. For additional information regarding manipulation under anesthesia for TMJ disorders, refer to the Medical Policy titled Manipulation Under Anesthesia.

While there are some data from several randomized trials and case series



Oxford


REVISED

Temporo-mandibular Joint Disorders

(continued)

Oct. 1, 2017

studies that certain types of passive rehabilitation techniques may improve jaw mobility early in recovery in patients who have undergone TMJ surgery, or have lost jaw mobility due to TMJ derangement or to contracture following

radiation therapy, these studies all included very small numbers of patients, and did not provide blinded assessment of outcomes, long-term follow-up, or information on optimal treatment protocols.

Further prospective controlled clinical trials that directly compare LLPS devices to other treatment modalities are needed.

Transcatheter Heart Valve Procedures

Nov. 1, 2017

Revised coverage rationale: o Updated coverage criteria for

aortic valve replacement: Replaced language

indicating “transcatheter aortic heart valve replacement is proven and medically necessary

for treating high risk patients [when listed

criteria is met]” with “transcatheter aortic heart valve replacement is proven and medically necessary for treating intermediate or higher risk patients [when listed

criteria is met] Replaced criterion

requiring “patient

requires valve replacement surgery but is at high risk for serious surgical complications or

death from open valve replacement surgery as determined by an interventional cardiologist and an experienced

Aortic Valve

Transcatheter aortic heart valve replacement is proven and medically necessary for treating intermediate or higher risk* patients when used according to U.S. Food and Drug Administration (FDA) labeled indications, contraindications, warnings and precautions, and ALL of the following criteria are met:

Severe calcific native aortic valve stenosis as indicated by one of the following:

o Mean aortic valve gradient >40 mmHg; or o Peak aortic jet velocity >4.0 m/s; or o Aortic valve area of ≤ 0.8 cm2

Patient is symptomatic [New York Heart Association (NYHA) class II or greater] and symptoms are due to aortic valve stenosis.

Patient requires valve replacement surgery but is at intermediate or higher risk* for serious surgical complications or death from open valve replacement surgery as determined by an interventional cardiologist and an experienced cardiothoracic surgeon.

*Society of Thoracic Surgeons (STS) risk categories are as follows

(Nishimura et al., 2014):

Intermediate - predicted risk of mortality (PROM) score of 4-8% High - PROM score of >8%

For a complete list of indications, contraindications, warnings and precautions by device, see the U.S. Food and Drug Administration (FDA) section of the policy. Pulmonary Valve

Transcatheter pulmonary heart valve replacement is proven and medically necessary when used according to FDA labeled indications,



Oxford


REVISED


(continued)

Nov. 1, 2017

cardiothoracic surgeon” with “patient requires valve replacement

surgery but is at intermediate or higher risk for serious surgical

complications or death from open valve replacement surgery as determined by an

interventional cardiologist and an experienced cardiothoracic surgeon”

Removed notation indicating “high risk” is

defined by the FDA as a predicted operative risk

score of >8% or an estimated >15% mortality risk for surgical aortic valve replacement (SAVR)

Added notation to indicate the Society of Thoracic Surgeons (STS) risk categories are as follows: - Intermediate:

Predicted risk of

mortality (PROM) score of 4-8%

- High: PROM score of >8%

o Updated coverage criteria for pulmonary valve

replacement: Replaced language

indicating “transcatheter

contraindications, warnings and precautions in patients with right ventricular outflow tract (RVOT) dysfunction with one of the following clinical indications for intervention:

Moderate or greater pulmonary regurgitation, and/or Pulmonary stenosis with a mean RVOT gradient ≥ 35 mmHg Mitral Valve

Percutaneous transcatheter mitral valve leaflet repair is unproven and not medically necessary. There is insufficient evidence in the clinical literature demonstrating the long-term efficacy of catheter-delivered mitral valve leaflet repair devices for treating mitral regurgitation. Further results from prospective, randomized

controlled trials are needed to determine device durability and the ideal candidates for the procedure. See the Benefit Considerations section of this policy for coverage of unproven services when certain conditions are met.

Percutaneous transcatheter mitral valve annuloplasty via the coronary sinus is unproven, not medically necessary and

investigational due to lack of FDA approval. There is insufficient evidence in the clinical literature demonstrating the long-term efficacy of coronary sinus annuloplasty devices for treating mitral

regurgitation. Further results from prospective, randomized controlled trials are needed to determine safety, efficacy, durability and the ideal candidates for the procedure.

Valve-in-Valve (ViV) Procedures

Transcatheter heart valve replacement within a failed bioprosthesis (valve-in-valve procedure) is unproven and not medically necessary. There is insufficient evidence in the clinical literature demonstrating the long-

term efficacy of ViV procedures. Further results from prospective studies are needed to determine the ideal candidates for this procedure. Cerebral Protection

Transcatheter cerebral protection devices (e.g., Sentinel™) are

unproven and not medically necessary. There is insufficient evidence in the clinical literature demonstrating the long-term efficacy of transcatheter cerebral protection devices in improving neurological and cognitive function following transcatheter aortic valve replacement.



Oxford


REVISED


(continued)

Nov. 1, 2017

pulmonary heart valve replacement is proven and medically necessary,

when used according to FDA labeled indications, contraindications,

warnings and precautions, in patients with right ventricular outflow tract (RVOT)

dysfunction who meet the [listed] criteria” with “transcatheter pulmonary heart valve replacement is proven and medically necessary,

when used according to FDA labeled indications,

contraindications, warnings and precautions, in patients with right ventricular outflow tract (RVOT)

dysfunction with one of the [listed] clinical indications for intervention”

Removed criterion requiring:

- Existence of a full

(circumferential) dysfunctional RVOT conduit that was equal to or greater than 16 mm in diameter when

originally implanted - Dysfunctional RVOT

conduit with one of



Oxford


REVISED


(continued)

Nov. 1, 2017 the [listed] clinical indications for intervention

o Added language to indicate transcatheter cerebral protection devices (e.g.,

Sentinel™) are unproven and not medically necessary; there is insufficient evidence in the clinical literature

demonstrating the long-term efficacy of transcatheter cerebral protection devices in improving neurological and cognitive function following transcatheter aortic

valve replacement Updated supporting information

to reflect the most current description of services, clinical evidence, FDA information, and references

Policy Title Effective Date Summary of Changes

RETIRED/REPLACED

Genetic Testing Nov. 1, 2017 Policy replaced; refer to the following Clinical Policies for applicable coverage guidelines: o Carrier Testing for Genetic Diseases o Genetic Testing for Hereditary Cancer o Pharmacogenetic Testing

o Whole Exome and Whole Genome Sequencing

Helicobacter Pylori Serology Testing

Oct. 1, 2017 Policy retired; helicobacter pylori serology testing no longer requires clinical coverage review



Oxford

Policy Title Effective Date Summary of Changes

RETIRED/REPLACED

Magnetoencephal-ography and Magnetic Source

Imaging for Specific Neurological

Applications

Oct. 1, 2017 Policy retired; magnetoencephalography and magnetic source imaging (MEG/MSI) no longer require clinical coverage review

Molecular Profiling to Guide Cancer Treatment

Nov. 1, 2017 Policy replaced; refer to the Clinical Policy titled Molecular Oncology Testing for Cancer Diagnosis, Prognosis and Treatment Decisions for applicable coverage guidelines

Wearable

Cardioverter-Defibrillators

Oct. 1, 2017 Policy retired; wearable cardioverter-defibrillators no longer require clinical coverage review



Oxford

Policy Title Effective Date Administrative Guidelines

NEW

Follow-Up Care Rendered in an Emergency Room

Site of Service

Nov. 1, 2017 Follow-up care provided in an emergency room (ER) site of service is not a covered benefit.

Prior to a network provider/facility rendering follow-up care to any Oxford Member in an ER site of service/setting, the provider/facility must inform the Oxford Member that follow-up care provided in an ER site service/setting is not a covered benefit under their Oxford plan. Additionally, the Oxford Member must be informed that they will be held financially responsible for the cost of all follow-up and/or routine medical care they choose to receive in an ER site of

service/setting rather than from their Primary Care Provider.

As a reminder, in-network providers may seek and collect payment from an Oxford Member for non-covered services only if the provider obtained the Member’s written consent, in advance of rendering the services, to be financially responsible for the total cost of the non-covered services.

Out-of-Network providers may bill Members directly for the entire cost of non-covered services, without first obtaining written consent.

Policy Title Effective Date Summary of Changes Administrative Guidelines

UPDATED

Claims Recovery

Nov. 1, 2017

Updated policy guidelines; added

notation (previously listed under

procedures and responsibilities) to indicate: o Once a provider is given

notice of the overpayment, Oxford will initiate discussions and take actions during the following one year

period. Clarified language outlining

procedures and responsibilities to indicate:

o Oxford will not pursue collection of overpayments

when the overpayments are identified as isolated mistakes or where the provider is not at fault, if the overpayments were more than one year prior to the date of notice of the

overpayment or use

Oxford will not pursue collection of overpayments when the overpayments

are identified as isolated mistakes or where the provider is not at fault, if the

overpayments were more than one year prior to the date of notice of the overpayment or use extrapolation. Examples include overpayments related to duplicate claims, fee schedule issues, isolated situations of incorrect billing/unbundling, and situations where Oxford was not the primary insurer. Exception: Oxford will pursue collection of overpayments beyond one year and utilize statistical methods and extrapolation in situations where:

Oxford has a reasonable suspicion of fraud or a sustained or high level of billing error; this includes situations such as: o Extensive or systemic upcoding o Unbundling

o Misrepresentation of services or diagnosis o Services not rendered

o Frequent waiver of member financial responsibility o Misrepresentation of provider rendering the services or licensure of

such provider, and similar issues or

A provider affirmatively requests additional payment on claims or issues older than one year, whether through suit, arbitration, or otherwise; or

The Centers for Medicare and Medicaid Services makes a retroactive

change to enrollment or to primary versus secondary coverage of a



Oxford


UPDATED

Claims Recovery (continued)

Nov. 1, 2017 extrapolation o Examples include

overpayments related to

duplicate claims, fee schedule issues, isolated situations of incorrect

billing/unbundling, and situations where Oxford was not the primary insurer


to reflect the most current references

Medicare plan member.

Credentialing Guidelines: Participation in the eviCore healthcare Network

Oct. 1, 2017

Updated policy guidelines to reflect the most current credentialing contact information: o The minimum standards for

consideration into the Oxford network can be found by clicking Network Standards on the lower left hand side of the eviCore page at https://www.evicore.com/pa

ges/providerlogin.aspx o Radiology centers in New

York (NY) and New Jersey (NJ) who are interested in participating in the Oxford network and radiology

centers that already

participate in the Oxford network and want to add a modality to their practice are required to email the eviCore Credentialing Department at [email protected] stating the nature of the

request along with the name, address and contact

Oxford has engaged eviCore healthcare (eviCore) to perform credentialing as well as quality and equipment review of outpatient diagnostic radiology centers who participate or wish to participate in the Oxford network. The minimum standards for consideration into the Oxford network can be

found by clicking Network Standards on the lower left hand side of the eviCore page at https://www.evicore.com/pages/providerlogin.aspx. Radiology centers in New York (NY) and New Jersey (NJ) who are interested in participating in the Oxford network and radiology centers that already participate in the Oxford network and want to add a modality to their practice

are required to email the eviCore Credentialing Department at [email protected] stating the nature of the request along with the name, address and contact email for facility. Credentials to access the online facility application through App Central will then be forwarded to the requestor via email.

Exception: Radiology centers performing outpatient radiology imaging

studies in Connecticut (CT) are excluded from the above credentialing requirements. Interpreting radiologists at facilities that are applying for a contract who are not currently credentialed by eviCore will need to complete a physician application and complete the physician credentialing process. Physician applications are also obtained by contacting [email protected].

https://www.evicore.com/pages/providerlogin.aspx


mailto:[email protected]






Oxford


UPDATED

Credentialing Guidelines: Participation in the

eviCore healthcare Network (continued)

Oct. 1, 2017 email for facility; credentials to access the online facility application through App

Central will then be forwarded to the requestor via email

o Interpreting radiologists at facilities that are applying for a contract who are not currently credentialed by

eviCore will need to complete a physician application and complete the physician credentialing process; Physician applications are also

available by emailing [email protected]

Filing Deadlines for Claims Submissions

Nov. 1, 2017

Updated definitions: o Added definition of “non-

participating provider” o Revised definition of

“participating provider” and

“provider” Revised guidelines for Filing

Deadlines for Original Claims:

Original Claim Filing Deadlines

for Providers o Removed example scenarios

o Replaced language indicating “when the member’s line of business (LOB) state and the provider’s state conflict, the

member’s LOB dictates the filing guideline” with “when the member’s LOB state and the provider’s state conflict, the member’s LOB governs

Filing Deadlines for Original Claims

Original Claim Filing Deadlines for Providers

Provider Status CT LOB NJ LOB NY LOB

Participating

90 days from the date of service

180 days from the date of service (DOS)

120 days from the date of service (DOS)

Non-participating

180 days from the date of service

Note: All New Jersey Non-Participating providers having rendered services to a

New Jersey member without an assignment of benefits elected are not eligible to submit claims for payment.

When the member’s line of business (LOB) state and the provider’s state

conflict, the member’s LOB state governs the filing deadline.




Oxford


UPDATED


(continued)

Nov. 1, 2017

the filing guideline”

Original Claim Filing Deadlines

for Members o Removed example scenarios o Modified notation to clarify

proof of loss means that the

member has not made an assignment to the provider and they are submitting the claims themselves

Exceptions to Original Claim

Deadlines for Providers and Members o Upated language to indicate:

Network providers, certain plans and

products and delegated

arrangement contracts may have specific filing deadlines listed in their contract; when a conflict between this policy and the provider,

plan/product, arrangement contract occurs, the provider, plan/product, arrangement contract governs the filing

deadline

If coordination of benefits (COB) has caused a delay in the receipt of an explanation of benefits (EOB), letter of denial, etc., from the

primary carrier, the provider will have 90 days from the date of

Original Claim Filing Deadlines for Members

Claims Submitted by Member Enrolled on a:

For Reimbursement of:

Original Claim

NJ LOB Services rendered

by a Non-participating

Provider

90 days from the DOS to

submit proof of loss*

NY LOB 120 Days from the DOS

All Other LOBs 180 Days from the DOS

*Proof of loss means that the member has not made an assignment to the

provider and they are submitting the claims themselves. If the member is unable to submit the claim for services within 90 days, the member must submit the claim as soon as it is reasonably possible to do so.

Exceptions to Original Claim Deadlines for Providers and Members

Network providers, certain plans and products and delegated arrangement contracts may have specific filing deadlines listed in their contract. When a conflict between this policy and the provider, plan/product, arrangement contract occurs, the provider, plan/product, arrangement contract governs the filing deadline.

If coordination of benefits (COB) has caused a delay in the receipt of an explanation of benefits (EOB), letter of denial, etc. from the primary carrier, the provider will have 90 days from the date of the primary carrier EOB to submit the claim to Oxford.

Inpatient hospital and facility claims utilize the discharge date as the starting point to determine the time frame for submission.

Maternity related services can be submitted up to 90 days from the delivery date.

If a previously denied authorization has been updated to an approved status, the date the appeal determination was made (as noted in the authorization) should be utilized as the starting point to determine the time frame for submission.

Except as otherwise specified in the member's benefit plan document,

failure to request reimbursement within the required time does not bar reimbursement if it was not reasonably possible to submit within the timeframe due to physical or mental incapacitation. However, the request



Oxford


UPDATED


(continued)

Nov. 1, 2017

the primary carrier EOB to submit the claim to Oxford

Inpatient hospital and facility claims utilize the discharge date as the

starting point to determine the time frame for submission

Maternity related

services can be submitted up to 90 days from the delivery date

If a previously denied authorization has been updated to an approved

status, the date the appeal determination

was made (as noted in the authorization) should be utilized as the starting point to determine the time

frame for submission Except as otherwise

specified in the member's benefit plan document, failure to request reimbursement

within the required time

does not bar reimbursement if it was not reasonably possible to submit within the timeframe due to physical or mental

incapacitation; however, the request must be made as soon as

must be made as soon as reasonably possible, as determined by Oxford. If a claim for a NY member is submitted past the filing deadline, a NY

Participating Provider may request reconsideration of the claim if the

participating provider has a historical pattern of timely submissions and the delay was due to an unusual occurrence (e.g., provider illness, provider's computer breakdown, fire, or flood).

Submission of Additional Information

Payment for services may be denied due to a lack of necessary, complete, or conflicting information. When Oxford denies a service requesting additional information, Commercial and Self-funded Members are given 45 days from the date of receipt of an Explanation of Benefits (EOB) or Remittance

Advice to submit the requested additional information, regardless of the provider’s status with the Oxford network.

Exception: Network providers, certain plans and products, and delegated arrangement contracts may have specific filing deadlines for the submission

of additional information listed in their contract that conflict with this policy. When a conflict between this policy and the provider, plan/product,

arrangement contract occurs the provider, plan/product, arrangement contract governs the filing deadline.

If the member wishes to submit the additional information outside of the allotted 45 days, he or she must submit an appeal of the initial decision.

Appeals

Guidelines and Processes

For appeals guidelines and processes, please refer to Oxford the following policies:

Member Administrative Grievance & Appeal (Non Utilization Management)

Process & Timeframes Practitioner/Provider Administrative Claim Reconsideration and Appeal

Process

Proof of Timely Filing

In the event that a provider disputes the denial of an original claim for untimely filing, the provider must be able to show proof of submission within the filing deadline.



Oxford


UPDATED


(continued)

Nov. 1, 2017

reasonably possible, as determined by Oxford

If a claim for a NY

member is submitted past the filing deadline, a NY Participating Provider

may request reconsideration of the claim if the participating provider has a historical

pattern of timely submissions and the delay was due to an unusual occurrence (e.g., provider illness, provider's computer

breakdown, fire, or flood)

Revised guidelines for Submission of Additional Information; updated exception language to indicate: o Network providers, certain

plans and products, and delegated arrangement contracts may have specific filing deadlines for the submission of additional information listed in their

contract that conflict with

this policy; when a conflict between this policy and the provider, plan/product, arrangement contract occurs the provider, plan/product, arrangement contract

governs the filing deadline Revised guidelines for Appeals:

Proof of Timely Filing

Note: If a claim for a NY member is submitted past the filing deadline, a NY Participating Provider may request reconsideration of the claim if the

participating provider has a historical pattern of timely submissions and the delay was due to an unusual occurrence (e.g., provider illness, provider's computer breakdown, fire, or flood).

Electronic Submission

As proof of timely filing, the provider must submit two EDI acceptance reports. One report will show the date the batch was sent, number of claims sent, and the number of accepted claims vs. rejected claims. The rejected claims will show error details and the claims should be corrected and resent.

The second report will show a listing of the claims by patient name that were received by the clearinghouse. These reports are supplied to Providers and facilities directly from the clearinghouse.

Note: Oxford will not accept a transmission report that only indicates the

claim(s) were sent to the clearinghouse as proof of timely filing. Providers are responsible for checking their clearinghouse reports to ensure that the claim

was accepted, and forwarded to Oxford.

Hardcopy Submission

As proof of timely filing, the provider must submit documentation showing that Oxford has received the hardcopy claim (receipt for certified letter, a copy of a screen print from the accounting software to show the date you submitted the claim, etc.).



Oxford


UPDATED


(continued)

Nov. 1, 2017

o Updated notation to indicate: If a claim for a NY

member is submitted

past the filing deadline, a NY Participating Provider may request

reconsideration of the claim if the participating provider has a historical pattern of timely

submissions and the delay was due to an unusual occurrence (e.g., provider illness, provider's computer breakdown, fire, or

flood) o Updated guidelines for

Electronic Submission; added language to clarify: As proof of timely filing,

the provider must submit two EDI acceptance

reports The second report will

show a listing of the claims by patient name that were received by the clearinghouse

Oxford will not accept a

transmission report that only indicates the claim(s) were sent to the clearinghouse as proof of timely filing

o Updated guidelines for

Hardcopy Submission; added language to clarify: As proof of timely filing,



Oxford


UPDATED


(continued)

Nov. 1, 2017 the provider must submit documentation showing that Oxford has received

the hardcopy claim (receipt for certified letter, a copy of a screen

print from the accounting software to show the date you submitted the claim,

etc.) Updated supporting information

to reflect the most current references

Precertification Exemptions for Outpatient Services

Oct. 1, 2017 Updated list of CPT codes for Pathology and Laboratory services that do not require

precertification in the office or outpatient setting to reflect quarterly code edits; added 0018U, 0019U, 0020U, 0021U, 0022U, and 0023U

Refer to the policy for complete details on the coverage guidelines for Precertification Exemptions for Outpatient Services.


REVISED

Accreditation Requirements for Radiology Services

Nov. 1, 2017

Updated definition/acronymn for American Society of Breast Surgeons (ASBS); previously

listed as ASBA Revised accreditation

requirements for radiologists, radiology centers and multi-

speciality provider groups; updated list of modalities/procedures for AIUM accreditation: o Added “Breast Ultrasound” o Removed:

In diagnostic imaging, accreditation programs have emerged as key initiatives to advance the quality and safety of imaging studies. It is important that Members receive services from facilities whose equipment,

technologists, and physicians are in compliance with established accreditation performance standards. All freestanding facilities and physician offices performing outpatient

radiology imaging studies are required to obtain and maintain accreditation as a condition for reimbursement for the below services.

Provider Specialty Accreditation Modality/Procedure

Radiologist, Radiology Facilities,

ACR MRI, Breast MRI, CT, Nuclear Medicine*, PET, Ultrasound, Breast



Oxford


REVISED


(continued)

Nov. 1, 2017

MRI CT Nuclear Medicine

PET o Replaced “Ultrasound

(vascular)” with “Ultrasound”

and Multi-Specialty Provider Groups

Ultrasound, Mammography, Stereotactic Biopsy

AIUM Ultrasound, Breast Ultrasound, Echocardiography

ASBS Breast Ultrasound, Stereotactic Breast Biopsy

IAC MRI, CT, Nuclear Medicine*, PET,

Ultrasound (vascular), Echocardiography

RadSite

(except cardiac procedures)

MRI, CT, Nuclear Medicine (SPECT)*, PET

TJC MRI, CT, Nuclear Medicine*, PET,

Ultrasound, X-ray, Breast Ultrasound, Stereotactic Breast Biopsy

Note: *Nuclear Medicine procedures noted with an (*) are only reimbursable to radiologists when they have the appropriate certification.

Please see Radiology Procedures Requiring Precertification for eviCore healthcare Arrangement for applicable CPT codes. Oxford has engaged eviCore healthcare to manage the accreditation process for our provider network. Accreditations should be faxed to eviCore healthcare at 866-699-8160 with the Accreditation Fax Cover sheet that can

be found on the eviCore healthcare website at www.evicore.com.

To ensure prompt handling of the accreditation please ensure that all applicable facility and physician information is included. If you have specific questions about the application process for accreditation, contact the ACR or IAC on their websites or by phone. For questions about

Oxford’s accreditation requirements, call 1-800-666-1353. In addition to accreditation, all radiologists and radiology centers in New York (NY) and New Jersey (NJ), who are interested in participating in the Oxford

https://www.carecorenational.com/page/practice-assessment-and-standards.aspx



Oxford


REVISED


(continued)

Nov. 1, 2017 network and/or radiologists and radiology centers that already participate in the Oxford network and want to add a modality to their practice must also be credentialed. Please refer to the policy titled Credentialing Guidelines:

Participation in the eviCore healthcare Network for additional information. Exception:

Radiologists and radiology centers performing outpatient radiology imaging studies in Connecticut (CT) are excluded from credentialing requirements (accreditation requirements are applicable).

Hospitals performing outpatient radiology imaging studies are excluded

from the accreditation requirements. All radiologists, radiology centers, and cardiologists in NY, NJ and CT who are currently participating in the Oxford network or wish to participate in the Oxford network and perform Coronary CT Angiography (CCTA) must also be credentialed. Refer to the policy titled Credentialing Guidelines: Participation

in the eviCore healthcare Network for additional information.



Oxford

Policy Title Effective Date Reimbursement Guidelines

NEW

Multiple Procedure Payment Reduction (MPPR) for

Diagnostic Cardiovascular and Ophthalmology

Procedures

Nov. 1, 2017

Multiple Diagnostic Cardiovascular Reductions (MDCR)

Oxford utilizes the CMS NPFS MPI of 6 and Non-Facility Total Relative Value Units (RVUs) to determine which Diagnostic Cardiovascular Procedures are eligible for MDCR to the TC portion of the procedure. When the TC for two or more Diagnostic Cardiovascular Procedures are performed on the same patient by the Same

Group Physician and/or Other Health Care Professional on the same day, Oxford will apply a MDCR to reduce the Allowable Amount for the TC of the second and each subsequent procedure by 25%. No reduction is taken on the TC with the highest TC Non-facility Total RVU according to the NPFS. The MDCR applies to the Technical Component Only codes (PC/TC Indicator 3), and to the TC portion of Global Procedure Codes (PC/TC Indicator 1). For Diagnostic Cardiovascular Procedures represented by a Global Test Only code (PC/TC Indicator 4), the reduction will be 25% of the corresponding Technical Component Only Code(s).

The MDCR will apply when: Multiple Diagnostic Cardiovascular Procedures with an MPI of 6 are performed on the same patient by the Same

Group Physician and/or Other Health Care Professional on the same day. A single Diagnostic Cardiovascular Procedure subject to the MDCR is submitted with multiple units. For example,

code 78445 is submitted with 2 units. A MDCR would apply to the TC of the second unit. The units allowed are also subject to Oxford's Maximum Frequency Per Day policy.

The MDCR will not apply when: Multiple Diagnostic Cardiovascular Procedures are billed, appended with modifier 26 for the Professional

Component (PC) only. MDCRs will not be applied to the PC. The procedure does not have an MPI of 6 and is not included on the Diagnostic Cardiovascular Procedures

Subject to MPPR lists in the Attachments section of the policy.

Multiple Diagnostic Ophthalmology Reductions (MDOR)

Oxford utilizes the CMS NPFS MPI of 7 and Non-Facility Total RVUs to determine which Diagnostic Ophthalmology Procedures are eligible for MDOR to the TC portion of the procedure.

When the TC for two or more Diagnostic Ophthalmology Procedures are performed on the same patient by the Same Group Physician and/or Other Health Care Professional on the same day, Oxford will apply a MDOR to reduce the Allowable Amount for the TC of the second and each subsequent procedure by 20%. No reduction is taken on the TC with the highest TC Non-Facility Total RVU according to the NPFS.

The MDOR applies to TC only services and the TC portion of Global Procedure Codes. The MDOR will apply when: Multiple Diagnostic Ophthalmology Procedures with an MPI of 7 are performed on the same patient by the Same



Oxford


NEW




Nov. 1, 2017

Group Physician and/or Other Health Care Professional on the same day. A single Diagnostic Ophthalmology Procedure subject to MDOR is submitted with multiple units. For example,

code 92060 is submitted with 2 units. A MDOR would apply to the TC of the second unit. The units allowed are

also subject to Oxford's Maximum Frequency Per Day policy. The MDOR will not apply when:

Multiple Diagnostic Ophthalmology Procedures are billed, appended with modifier 26 for the PC only. MDORs will not be applied to the PC.

The procedure does not have an MPI of 7 and is not included on the Diagnostic Ophthalmology Procedures Subject to MPPR list in the Attachments section of the policy.

Multiple Diagnostic Cardiovascular and Ophthalmology Procedures Billed Globally

When the Same Group Physician and/or Other Health Care Professional bills multiple Diagnostic Cardiovascular Procedure Global Procedure Codes (PC/TC indicator 1) and/or Global Test Only Codes (PC/TC indicator 4); or multiple Diagnostic Ophthalmology Procedure Global Procedure Codes (PC/TC indicator 1) the procedures will be ranked to determine which procedure(s) are considered secondary or subsequent as indicated below:

For Diagnostic Cardiovascular or Diagnostic Ophthalmology Global Procedure Codes (assigned PC/TC Indicator 1):

When a provider bills globally for two or more procedures subject to multiple diagnostic cardiovascular or ophthalmology reduction, the charge for the Global Procedure Codes will be divided into the PC and TC (indicated by

modifiers 26 and TC) using Oxford's standard Professional/Technical percentage splits. Refer to the Oxford Employer & Individual Professional/Technical Component Policy for applicable PC/TC splits. Ranking is based on the TC Non-Facility Total RVU and a reduction of 25% will be applied for MDCR and 20% will be applied for MDOR. For Diagnostic Cardiovascular Procedures Global Test Only Codes (PC/TC Indicator 4):

When a provider bills for two or more Diagnostic Cardiovascular Procedures represented by a Global Test Only code, a reduction of 25% will be applied to the corresponding Technical Component Only Code(s) (PC/TC Indicator 3). No reduction will apply to the corresponding Professional Component Only Code(s). Refer to Q&A #5 in the Questions

and Answers section of the policy for an example of how the MDCR reduction is applied.

Diagnostic Cardiovascular and Ophthalmology Procedures with No Assigned CMS RVU

Services that CMS indicates may be carrier-priced, or those for which CMS does not develop RVUs are considered Gap Fill Codes and are addressed as follows: Gap Fill Codes: When data is available for Gap Fill Codes, Oxford uses the RVUs published in the first quarter

update of the Optum The Essential RBRVS publication for the current calendar year. A Diagnostic Cardiovascular Procedure or Diagnostic Ophthalmology Procedure assigned a gap value, will be denoted with an asterisk (*) next to the code in the applicable code list.



Oxford


NEW




Nov. 1, 2017

RVU Codes: Some codes cannot be assigned a gap value or remain without an RVU due to the nature of the service (example: unlisted codes). Codes assigned an RVU value of 0.00 will not be included in the Diagnostic Cardiovascular Procedures or Diagnostic Ophthalmology Procedures Subject to MPPR Policy Lists and therefore,

will be excluded from ranking.

Policy Title Effective Date Summary of Changes Reimbursement Guidelines

REVISED

Consultation Services

Oct. 1, 2017

On hold; effective date

TBD

Notice of Implementation Delay: This policy will not be revised on Oct. 1, 2017 as previously announced. Implementation of the revisions noted below has been

delayed until further notice;

complete details will be provided in a future edition of the Policy Update Bulletin. Updated list of related policies;

added reference link to policy titled Telemedicine

Modified policy overview language to indicate this policy discusses how Oxford evaluates consultation HCPCS codes G0406-G0408, G0425-G0427,

G0508 and G0509 for reimbursement and how services rendered at the request of another physician or appropriate source may be reported in lieu of CPT® consultation services codes 99241-99245 and 99251-99255

Reorganized and revised reimbursement guidelines for consultation services:

Refer to the policy for complete details on applicable reimbursement guidelines.

https://www.oxhp.com/secure/policy/consultation_services_1017.pdf




Oxford


REVISED

Consultation Services (continued)

Oct. 1, 2017

On hold; effective date TBD

o Removed/replaced language indicating: Oxford will consider a

claim for a consultation service for reimbursement if the

requesting physician or other qualified source is identified on the claim

Services initiated by a

patient and/or family and not requested by a physician or other appropriate source should not be reported using CPT consultation

codes 99241-99245 or 99251-99255 or HCPCS

consultation codes G0406-G0408 or G0425-G0427, but may be reported using appropriate office visit,

hospital care, home service or domiciliary/rest home care codes

AMA guidelines state that only one inpatient

consultation (99251-

99255) should be reported by a consultant per admission; evaluation and Management (EM) services after the initial

consultation during a single admission should be reported using non-





Oxford


REVISED


Oct. 1, 2017


consultation EM codes o Added guidelines for

Consultation Services for

Dates of Service Through 09/30/2017 to indicate: Oxford reimbursed

consultation services in alignment with the consultation services coding guidelines

published within the American Medical Association (AMA) Current Procedural Terminology (CPT®) book

That description states a consultation is a type of

evaluation and management service provided at the request of another physician or appropriate source to

either recommend care for a specific condition or problem or to determine whether to accept responsibility for ongoing management of the

patient's entire care or

for the care of a specific condition or problem

o Added guidelines for Consultation Services for Dates of Service Beginning 10/01/2017

and after to indicate: Oxford aligns with the

Centers for Medicare &





Oxford


REVISED


Oct. 1, 2017


Medicaid Services (CMS) and does not reimburse consultation services

procedure codes 99241-99245 and 99251-99255 including when reported

with telehealth modifiers The codes eligible for

reimbursement are those that identify the

appropriate Evaluation and Management (E/M) procedure code which describes the office visit, hospital care, nursing facility care, home

service or domiciliary/rest home

care service provided to the patient

Oxford continues to consider initial inpatient, follow-up inpatient,

critical care and emergency department consultations performed via telehealth for reimbursement; these services are represented

by HCPCS codes G0406-

G0408, G0425-G0427, and G0508-G0509

Telehealth consultation services must also be billed with either the -GT or -GQ modifier to

identify the telehealth technology used to provide the service; for





Oxford


REVISED


Oct. 1, 2017


more information regarding reimbursement of

telemedicine services, refer to the policy titled Telemedicine

For HCPCS codes G0406-G0408, G0425-G0427, and G0508-G0509 to be considered for

reimbursement, the following documentation requirements must be met: - A written or verbal

request for consult

must be made by an appropriate source

- The request must be documented in the patient’s medical record

- The consultant’s

opinion must be documented in the patient’s medical record

- The consultant’s opinion must be

communicated by

written report to the requesting physician or other appropriate source

The requesting physician or other appropriate

source must be identified on the claim; if the requesting entity is not





Oxford


REVISED


Oct. 1, 2017


identified on the claim, the consultation service will be denied because it

does not meet requirements for reporting such a code

CPT consultation services and telehealth consultation services should only be reported

when a transfer of care has not occurred - A transfer of care

occurs when a physician or qualified health care

professional requests that another

physician or qualified health care professional take over the responsibility for

managing the patient’s complete care for the condition and does not expect to continue treating or caring for the

patient for that

condition Removed definition of

“consultation service” Updated list of applicable CPT

codes; removed 99241, 99242, 99243, 99244, 99425, 99251,

99252, 99253, 99254, and 99255

Updated list of applicable HCPCS





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REVISED


Oct. 1, 2017


codes; added G0508 and G0509 Updated Questions & Answers

(Q&A):

o Revised Q&A#1 pertaining to “appropriate sources” for requesting telehealth

consultation services o Revised Q&A #2 pertaining

to consultation and non-consultation telehealth

service codes o Added Q&A#3 pertaining to

consultation code denials (CPT codes 99241-99245 and 99251-99255)

o Removed Q&A pertaining to

examples of sources when it is not appropriate for a

physician or other health care professional to report a consultation service code

Global Days

Oct. 1, 2017


Notice of Implementation Delay: This policy will not be revised on

Oct. 1, 2017 as previously announced. Implementation of the revisions noted below has been delayed until further notice; complete details will be provided in a future edition of the Policy Update

Bulletin.

Revised list of Evaluation and

Management (E/M) Services Included in the Global Period (attachment file); removed CPT codes 99241, 99242, 99243, 99244, 99245, 99251, 99252,

99253, 99254, and 99255




https://www.oxhp.com/secure/policy/global_days_policy_1017.pdf



Oxford


REVISED

Injection and Infusion Services

Oct. 1, 2017


Notice of Implementation Delay: This policy will not be revised on Oct. 1, 2017 as previously

announced. Implementation of the revisions noted below has been delayed until further notice;

complete details will be provided in a future edition of the Policy Update Bulletin.

Revised list of Evaluation and Management (E/M) Codes for Injection Codes 96372-96379 (attachment file listing E/M codes that apply when reported with injection codes 96372-

96379); removed 99241, 99242, 99243, 99244, 99245, 99251,

99252, 99253, 99254, and 99255


Maximum Frequency Per Day

Oct. 1, 2017

On hold;

effective date TBD

Notice of Implementation Delay: This policy will not be revised on Oct. 1, 2017 as previously

announced. Implementation of the revisions noted below has been delayed until further notice; complete details will be provided in a future edition of the Policy Update Bulletin.

Revised Maximum Frequency Per Day Code List (attachment file designating the maximum frequency per day value assignments for CPT and HCPCS codes); removed 99241, 99242, 99243, 99244, 99245, 99251,

99252, 99253, 99254, and 99255

Refer to the policy for complete details on applicable reimbursement

guidelines.

https://www.oxhp.com/secure/policy/injection_and_infusion_services_policy_1017.pdf

https://www.oxhp.com/secure/policy/injection_and_infusion_services_policy_1017.pdf

https://www.oxhp.com/secure/policy/maximum_frequency_per_day_1017.pdf




Oxford


REVISED

Maximum Frequency Per Day (continued)

Oct. 1, 2017


Revised list of Codes Restricting Modifiers LT and RT (attachment file listing codes that allow up to

the MFD limit that have “bilateral” or “unilateral or bilateral” in the description or

where the concept of laterality does not apply); removed 99241, 99242, 99243, 99244, 99245, 99251, 99252, 99253,

99254, and 99255

Obstetrical Policy

Oct. 1, 2017

Notice of Revision: The following summary of changes has been modified. Implementation of the revision noted in red below has been delayed until further notice; complete details will be provided in a

future edition of the Policy Update Bulletin. Updated reimbursement

guidelines; removed language pertaining to date ranges that

span across the effective date of ICD-9 CM to ICD-10 CM for antepartum services

Updated definitions; added definition of: o Modifier 76 (repeat

procedure or service by

same physician or other qualified health care professional)

o Modifier 77 (repeat procedure or service by another physician or other qualified health care

professional) Updated Questions and Answers






Oxford


REVISED

Obstetrical Policy (continued)

Oct. 1, 2017

(Q&A) #8; removed CPT codes 99241, 99242, 99243, 99244, and 99245

Preventive Medicine and

Screening

Oct. 1, 2017

On hold;

effective date TBD

Notice of Implementation Delay: This policy will not be revised on

Oct. 1, 2017 as previously announced. Implementation of the revisions noted below has been delayed until further notice; complete details will be provided in a

future edition of the Policy Update Bulletin.

Revised list of applicable CPT

codes for “Other Evaluation and Management (E/M) Services”; removed 99241, 99242, 99243,

99244, 99245, 99251, 99252, 99253, 99254, and 99255


Prolonged Services

Nov. 1, 2017

Revised policy overview langauge to indicate: o This policy identifies when

Oxford will separately reimburse physicians or

other health care professionals for Prolonged Services when reported in conjunction with companion

Evaluation & Management (E/M) codes or other services

o In accordance with The Centers for Medicare and Medicaid Services (CMS), Prolonged Services without Direct Patient Contact (CPT codes 99358–99359) will not

be separately reimbursed

Oxford reimburses Prolonged Services when reported with E/M codes in which time is a factor in determining level of service in accordance with CPT guidelines. Physicians or other health care professionals should report only Prolonged Services beyond the typical duration of the service on a given date, even if

the time spent by the physician or other care professional is not continuous. Providers should not include the time devoted to performing separately reportable services when determining the amount of prolonged services time. For example, the time devoted to performing cardiopulmonary resuscitation

(CPT code 92950) should not be included in prolonged services time. A prolonged service of less than 30 minutes total duration on a given date is not separately reported because the work involved is included in the total

work of the evaluation and management codes. Report CPT code 99354 (office or outpatient place of service codes) for

the first hour of prolonged physician or other qualified health care professional services. This code should be used only once per date, and prolonged services must exceed 30 minutes in order to report this

service.



Oxford


REVISED

Prolonged Services (continued)

Nov. 1, 2017

when reported with Complex Chronic Care Management (CCM) CPT codes 99487 and

99489 and Transitional Care Management (TCM) CPT codes 99495 and 99496

o For the purpose of this policy, the Same Individual Physician or Other Health Care Professional is the

same individual rendering health care services reporting the same Federal Tax Identification number

Revised reimbursement guidelines:

o Replaced references to: “Prolonged services with

direct patient contact” with “prolonged services”

“American College of Obstetricians and

Gynecologists (ACOG)” with “American Congress of Obstetricians and Gynecologists (ACOG)”

o Updated instructions for reporting CPT codes 99354,

99355, 99345 and 99357;

replaced reference to “prolonged services” with “prolonged physician or other qualified health care professional services”

o Updated reference to

applicable Place of Service codes for reporting for CPT codes 99356 and 99357;

Report CPT code 99355 (office or outpatient place of service codes) for each additional 30 minutes beyond the first 60 minutes of prolonged physician or other qualified health care professional services. Additional

services must exceed 15 minutes in order to report this service. Report CPT code 99356 (inpatient or observation place of service code)

for the first hour of prolonged physician or other qualified health care

professional services. This code should be used only once per date, and prolonged services must exceed 30 minutes in order to report this service.

Report CPT code 99357 (inpatient or observation place of service code)

for each additional 30 minutes beyond the first 60 minutes of prolonged physician or other qualified health care professional services. Additional services must exceed 15 minutes in order to report this service.

Report CPT code 99358 (office, outpatient, inpatient or observation place of service codes) for the first hour of prolonged physician or other qualified health care professional services. This code should be used only

once per date, and prolonged services must exceed 30 minutes in order to report this service.

Report CPT code 99359 (office, outpatient, inpatient or observation place of service codes) for each additional 30 minutes beyond the first 60 minutes of prolonged physician or other qualified health care professional services. Additional services must exceed 15 minutes in order to report this service.

Report CPT code 99415 (office or outpatient place of service codes) for the first hour of prolonged clinical staff services of direct patient contact with physician supervision. This code should be used only once per date, and prolonged services must exceed 30 minutes in order to report this service.

Report CPT code 99416 (office or outpatient place of service codes) for

each additional 30 minutes beyond the first 60 minutes of prolonged

clinical staff services of direct patient contact with physician supervision. Additional services must exceed 15 minutes in order to report this service.

According to CPT, prolonged service codes 99354–99357, 99415 and 99416 are considered add-on codes and should not be reported

without the appropriate primary code. Refer to the Add-On Policy for details.

Prolonged services for labor and delivery are not separately



Oxford


REVISED


Nov. 1, 2017

replaced “inpatient” with “ inpatient or obeservation”

o Added language to indicate:

Report CPT code 99358 (office, outpatient, inpatient or observation

place of service codes) for the first hour of prolonged physician or other qualified health

care professional services; this code should be used only once per date, and prolonged services must exceed 30 minutes in order to

report this service Report CPT code 99359

(office, outpatient, inpatient or observation place of service codes) for each additional 30 minutes beyond the first

60 minutes of prolonged physician or other qualified health care professional services; additional services must exceed 15 minutes in

order to report this

service o Updated language pertaining

to Centers for Medicare Services (CMS) guidance to indicate prolonged services without direct patient

contact (CPT codes 99358 and 99359) will not be separately reimbursed when

reimbursable services. As described in American Congress of Obstetricians and Gynecologists (ACOG) coding guidelines, prolonged services are not reported for services

that do not have a time component such as labor and delivery management. Refer to the Obstetrical Policy for more information.

In accordance with The Centers for Medicare Services (CMS), Prolonged Services without Direct Patient Contact (CPT codes 99358–99359) will not be separately reimbursed when reported with CCM CPT codes 99487 and 99489 and TCM CPT codes 99495 and

99496.



Oxford


REVISED


Nov. 1, 2017 reported with CCM CPT codes 99487 and 99489 and TCM CPT codes 99495 and

99496 Updated list of

applicable/reimbursable CPT

codes; added 99358 and 99359

Replacement Codes

Nov. 1, 2017

Revised reimbursement guidelines; added language to indicate the physician or

healthcare professional is required to report the replacement code that best describes the service provided

Revised list of Replacement Codes (attachment file listing procedure codes assigned a

status code “I” and included in Oxford’s Replacement Codes Policy): o Removed:

I status code 77385 with corresponding

replacement code G6016 I status code 77386 with

corresponding replacement code G6015

o Reformatted attachment; transferred content to

embedded Excel file

Per the public use file that accompanies the NPFS Relative Value File, the following is stated for status code “I”: Not valid for Medicare purposes. Medicare uses another code for reporting of, and payment for, these

services. In certain instances CMS creates Healthcare Common Procedure Coding System (HCPCS) replacement codes for physicians and/or healthcare professionals to report in lieu of the Current Procedural Terminology (CPT®) or HCPCS codes assigned an “I” status. The replacement codes allow for additional code specificity so that the appropriate reimbursement and

beneficiary coverage can be applied for the service provided. In the example below CMS has replaced intraoperative neurophysiology CPT code 95941 with HCPCS code G0453 which is specific to a single beneficiary. Note: RVU values may not accurately reflect the current NPFS and are

intended for illustrative purposes only.

NPFS Status

Code Description RVU

I = Not

valid for Medicare purposes

95941

Continuous intraoperative neurophysiology monitoring, from outside

the operating room (remote or nearby) or for monitoring of more than one case

while in the operating room, per hour (List separately in addition to code for primary procedure)

0.00

A = Active Code

G0453

Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby),

per patient, (attention directed exclusively to one patient) each 15

0.93



Oxford


REVISED

Replacement Codes (continued)

Nov. 1, 2017 minutes (list in addition to primary procedure)

Consistent with CMS, Oxford will not separately reimburse for specific CPT or

HCPCS codes assigned a status code “I” on the NPFS Relative Value File, indicating another code (replacement code) is used to report the procedure

or service and that replacement code has an assigned RVU. Codes from the NPFS with a status of “I” addressed in other Oxford reimbursement policies, codes with no identified replacement code and those where the replacement code does not have an RVU are not included in this policy. The physician or

healthcare professional is required to report the replacement code that best describes the service provided.

Supply Policy

Nov. 1, 2017

Updated policy overview; added reference link to the Centers for Medicare & Medicaid Services (CMS) Place of Service (POS) Code Set

Revised reimbursement guidelines: Supply Reimbursement in a Physician’s or Other Qualified Health Care Professional’s Office and Other Nonfacility Places of Service

o Replaced language indicating “the Oxford Supply Policy Codes List (in the Attachments section [of the policy]) contains the codes

that are not separately reimbursable under this

policy” with “the Oxford Supply Policy Codes List contains the codes that are not separately reimbursable in an office and other nonfacility places of service”

o Added instruction to refer to the Attachments section of

Supply Reimbursement in a Physician’s or Other Qualified Health Care Professional’s Office and Other Nonfacility Places of Service

Pursuant to Centers for Medicare and Medicaid Services (CMS) policy, certain HCPCS supply codes are not separately reimbursable as the cost of supplies is incorporated into the Practice Expense Relative Value Unit (RVU) for the

Evaluation and Management (E/M) service or procedure code. Consistent with CMS, Oxford will not separately reimburse the HCPCS supply codes when those supplies are provided on the same day as an E/M service and/or

procedure performed in a physician’s, or other qualified health care professional’s office and other nonfacility places of service. The Oxford Supply Policy Codes list contains the codes that are not separately reimbursable in an office and other nonfacility places of service. It is developed based on the CMS National Physician Fee Schedule (NPFS)

Relative Value File and consists of codes that based on their descriptions, CMS considers part of the practice expense and not separately reimbursable.

Please refer to the Attachments section of the policy for a list of those codes/services that are not separately reimbursable in POS 1, 3, 4, 9, 11, 12, 13, 14, 15, 16, 17, 20, 33, 49, 50, 54, 55, 57, 60, 62, 65, 71, 72, 81 and 99.

Reimburesment for Supplies, Purchased Durable Medical Equipment (DME), Orthotics, Prosthetics, Biologicals and Drugs submitted with a J Code Reported with a Facility Place of Service 19, 21, 22, 23, 24

CMS follows a Prospective Payment System (PPS) where Medicare payment is based on a predetermined, fixed amount payable to a facility for inpatient



Oxford


REVISED

Supply Policy (continued)

Nov. 1, 2017

the policy for a list of codes/services that are not separately reimbursable in

POS 1, 3, 4, 9, 11, 12, 13, 14, 15, 16, 17, 20, 33, 49, 50, 54, 55, 57, 60, 62, 65,

71, 72, 81, and 99 Reimbursement for Supplies, Purchased Durable Medical Equipment (DME), Orthotics,

Prosthetics, Biologicals and Drugs submitted with a J Code Reported with a Facility Place of Service 19, 21, 22, 23, 24 o Added language to indicate

the Oxford Supply Policy Code list and Supply Facility

J-Code Denial Code list (see the Attachments section of the policy) contain codes that are not separately reimbursable in a facility

place of service Durable Medical Equipment, Orthotics, Prosthetics, and Related Supplies Reported with Facility Places of Service 31 and 32

o Reorganized

content/language for clarity (no change to reimbursement guidelines)

Reformatted attachments; transferred content to embedded Excel files

Revised Supply Facility J-Code Denial Code List (attachment file listing drug codes that are not

or outpatient hospital services. In addition, CMS reimburses ambulatory surgery centers under an Ambulatory Payment Classification (APC) payment methodology. With these fixed rates all costs associated with drugs and

supplies are also deemed included in the global payment to the facility and not considered separately reimbursable when reported on a CMS-1500 claim form by a physician or other qualified healthcare professional.

Consistent with CMS, Oxford will not allow separate reimbursement for specific HCPCS supplies, purchased DME, orthotics, prosthetics, biological, and drugs reported with a HCPCS J code when submitted on a CMS-1500

claim form by any physician or other qualified healthcare professional in the following facility POS 19, 21, 22, 23, and 24. The Oxford Supply Policy Code list and Supply Facility J-Code Denial Code list (see the Attachments section of the policy) contains the codes that are not separately reimbursable in a facility place of service.

In addition, the purchase of certain DME, orthotics, and prosthetics will not be separately reimbursed when reported by a physician or other qualified

health care professional on a CMS-1500 claim form in POS 19, 21, 22, 23 or 24 and the services are reported with no modifier or with one of the following purchase modifiers: NU - New equipment (use the NR modifier when DME which was new at

the time of rental is subsequently purchased).

UE - Used equipment NR - New when rented KM - Replacement of facial prosthesis including new impression/moulage KN - Replacement of facial prosthesis using previous master model Please refer to the Attachments section of the policy for a list of those

codes/services that are not separately reimbursable in POS 19, 21, 22, 23

and 24. Durable Medical Equipment, Orthotics, Prosthetics, and Related Supplies Reported with Facility Places of Service 31 and 32

In alignment with the CMS PPS reimbursement methodology, Oxford considers payment for certain DME, orthotics, prosthetics and related supply items on the CMS Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) fee schedule to be included in the payment to a skilled nursing facility (POS 31) and nursing facility (POS 32) and not reimbursed



Oxford


REVISED


Nov. 1, 2017

separately reimbursable in POS 19, 21, 22, 23, or 24); removed J7297, J7298, J7300, J7301,

J7306, and J7307

separately when reported by a physician or other qualified health care professional on a CMS-1500 claim form.

Please refer to the Attachments section of this policy for a list of codes/services that are not separately reimbursable in POS 31 and 32. Bundling HCPCS Code L8680 with CPT Code 63650

To further align with CMS, the Oxford Supply Policy will deny HCPCS code L8680 (Implantable neurostimulator electrode), when billed with CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural) in an office or nonfacility place of service. Casting and Splint Supplies

HCPCS codes A4570, A4580, and A4590 which were previously used for

billing of splints and casts are invalid for Medicare use effective July 1, 2001, and new temporary Q codes were established to reimburse physicians and other practitioners for the supplies used in creating casts. Consistent with

CMS, Oxford will no longer reimburse HCPCS codes A4570, A4580, and A4590 for casting and splint supplies. Physicians and other qualified health care professionals should be using the temporary Q codes (Q4001-Q4051) for reimbursement of casting and splint supplies.

Implantable Tissue Markers

CMS clarifies that implantable tissue markers (HCPCS code A4648) and implantable radiation dosimeters (HCPCS code A4650) are separately billable and payable when used in conjunction with CPT codes 19499, 32553, 49411 or 55876 on a claim for physician or other qualified health care professional services. Consistent with CMS, Oxford will allow separate reimbursement for HCPCS codes A4648 and A4650 when billed on the same date of service with

either CPT codes 19499, 32553, 49411 or 55876. If not reported with at

least one of these CPT codes, HCPCS codes A4648 and A4650 are not separately reimbursable. Supply Code 99070

For reimbursement of covered medical and surgical supplies, an appropriate Level II HCPCS code must be submitted. The non-specific CPT code 99070 (supplies and materials, except spectacles, provided by the physician or other qualified health care professional over and above those usually



Oxford


REVISED


Nov. 1, 2017 included with the office visit or other services rendered (list drugs, trays, supplies, or materials provided)) is not reimbursable in any setting.

Urgent Care

Dec. 1, 2017

Revised reimbursement

guidelines; added language to indicate:

o HCPCS code S9083 (global fee urgent care centers) is a global code that does not provide specific information about the services provided;

Oxford will begin to require the specific codes for the services instead of allowing reimbursement for S9083 This change will be

implemented in a phased approach by state,

beginning with dates of service on or after December 1, 2017

Providers should submit claims with specific CPT/HCPCS codes

describing the services o S9083 will not be

reimbursed for dates of service on or after December 1, 2017 for the state of New York (NY) only; this applies

to provider claims for care

delivered in NY (provider practice state)

Revised list of applicable HCPCS codes; added S9083

The American Medical Association Current Procedural Terminology (CPT®)

Professional Edition gives the following instruction for code selection: “Select the name of the procedure or service that accurately identifies the service

performed.” According to Centers for Medicare and Medicaid Services (CMS), Place of Service (POS) Codes Database: “Place of service codes and descriptions should be used on professional claims to specify the entity where service(s)

were rendered.” Consistent with CPT® and CMS, physicians and other healthcare professionals should report the evaluation and management, and/or procedure code(s) that specifically describe the service(s) performed. Additionally a place of service code should be utilized to report where service(s) were rendered.

Oxford will not reimburse HCPCS code S9088 [services provided in an urgent care center (list in addition to code for service)]. S9088 is informational as it pertains to the place of service not the specific service provided. HCPCS code S9083 (global fee urgent care centers) is also a global

code that does not provide specific information about the services provided. Oxford will begin to require the specific codes for the services instead of allowing reimbursement for S9083. This change will be implemented in a phased approach by state, beginning with dates of service on or after December 1, 2017. Providers should submit claims with the specific CPT/HCPCS codes that describe the services. Refer to

the State Exceptions section below for information regarding the dates of

implementation for each state. State Exceptions

State Description

New York

S9083 (global fee urgent care centers) will not be reimbursed for dates of service on or after December 1,

2017 (state of New York only); this applies to provider claims for care delivered in NY (provider practice state)



Oxford


REVISED

Urgent Care (continued)

Dec. 1, 2017 New Jersey Not applicable

Connecticut Not applicable

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