Oxford

June 2018 policy update bulletin

Medical & Administrative Policy Updates

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

Oxford ® Oxford Medical and Administrative Policy Updates Overview

This bulletin provides complete details on Oxford® Clinical, Policy Update Classifications Administrative and Reimbursement Policy updates. The inclusion of New a health service (e.g., test, drug, device or procedure) in this New clinical coverage criteria and/or documentation review bulletin indicates only that UnitedHealthcare has recently adopted a requirements have been adopted for a health service (e.g., test, drug, new policy and/or updated, revised, replaced or retired an existing device or procedure) policy; it does not imply that Oxford® provides coverage for the Updated health service. In the event of an inconsistency or conflict between An existing policy has been reviewed and changes have not been made the information provided in this bulletin and the posted policy, the to the clinical coverage criteria or documentation review requirements; provisions of the posted policy will prevail. Note that most benefit however, items such as the clinical evidence, FDA information, and/or plan documents exclude from benefit coverage health services list(s) of applicable codes may have been updated identified as investigational or unproven/not medically necessary. Physicians and other health care professionals may not seek or Revised collect payment from a member for services not covered by the An existing policy has been reviewed and revisions have been made to applicable benefit plan unless first obtaining the member’s written the clinical coverage criteria and/or documentation review requirements consent, acknowledging that the service is not covered by the Replaced benefit plan and that they will be billed directly for the service. An existing policy has been replaced with a new or different policy

A complete library of Oxford® Medical and Retired Administrative Policies is available at The health service(s) addressed in the policy are no longer being OxfordHealth.com > Providers > Tools & Resources > managed or are considered to be proven/medically necessary and are Medical Information > Medical and Administrative Policies. therefore not excluded as unproven/not medically necessary services, unless coverage guidelines or criteria are otherwise documented in

another policy Tips for using the Policy Update Bulletin:  From the table of contents, click the policy title to be Note: The absence of a policy does not automatically indicate or imply directed to the corresponding policy update summary. coverage. As always, coverage for a health service must be determined in accordance with the member’s benefit plan and any applicable  From the policy updates table, click the policy title to view a federal or state regulatory requirements. Additionally, UnitedHealthcare complete copy of a new, updated, or revised policy. reserves the right to review the clinical evidence supporting the safety and effectiveness of a medical technology prior to rendering a coverage determination.

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Clinical Policy Updates Page UPDATED  Assisted Administration of Clotting Factors and Coagulant Blood Products - Effective Jul. 1, 2018 ...... 6  Carrier Testing for Genetic Diseases - Effective Jul. 1, 2018 ...... 6  Cosmetic and Reconstructive Procedures - Effective Jul. 1, 2018 ...... 6  Gastrointestinal Motility Disorders, Diagnosis and Treatment - Effective Jul. 1, 2018 ...... 6  Gynecomastia Treatment - Effective Jun. 1, 2018 ...... 6  Intrauterine Fetal Surgery - Effective Jun. 1, 2018 ...... 6  Macular Degeneration Treatment Procedures - Effective Jul. 1, 2018 ...... 7  Mifeprex® (Mifepristone) - Effective Jun. 1, 2018 ...... 7  Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions - Effective Jul. 1, 2018 ...... 7  Occipital Neuralgia and Headache Treatment - Effective Jul. 1, 2018 ...... 7  Prolotherapy for Musculoskeletal Indications - Effective Jun. 1, 2018 ...... 7  Repository Corticotropin Injection (H.P. Acthar Gel®) - Effective Jun. 1, 2018 ...... 7  Routine Foot Care - Effective Jul. 1, 2018 ...... 8  Transpupillary Thermotherapy - Effective Jun. 1, 2018 ...... 8 REVISED

 Alpha1-Proteinase Inhibitors - Effective Jul. 1, 2018 ...... 8  Clotting Factors and Coagulant Blood Products - Effective Jul. 1, 2018 ...... 10  Denosumab (Prolia® & Xgeva®) - Effective Jun. 1, 2018 ...... 13  Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Jul. 1, 2018 ...... 17  Drug Coverage Guidelines - Effective Jun. 1, 2018 ...... 18 o Prolia, Xgeva (Denosumab) ...... 18  Drug Coverage Guidelines - Effective Jul. 1, 2018 ...... 18 o Aralast NP [Alpha1-Proteinase Inhibitor (Human)] ...... 18 o Balcotra (Ethinyl Estradiol/Levonorgestrel/Ferrous Bisglycinate) ...... 18 o Bevyxxa (Betrixaban) ...... 19 o Buphenyl (Sodium Phenylbutyrate) ...... 19 o Cerezyme® (Imiglucerase) ...... 19 o Chemotherapy (Injectable) Drugs) ...... 19 o Climara (Brand Only) (Estradiol) ...... 19 o Codeine/Phenylephrine/Promethazine ...... 19 o Codeine/Promethazine ...... 19 o Crinone (Progesterone Gel) ...... 19 o Effient (Prasugrel) (Brand Only) ...... 20

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o Elelyso (Taliglucerase Alfa) ...... 20 o Flowtuss (Hydrocodone/Guaifenesin) ...... 20 o Fosrenol Chewable Tablets (Lanthanum Carbonate) (Brand Only) ...... 20 o Glassia [Alpha1-Proteinase Inhibitor (Human)] ...... 20 o Hemlibra (Emicizumab-Kxwh) ...... 20 o Hemophilia Drugs ...... 21 o Humira () 10 mg/0.1 ml, 20 mg/0.2ml, 40 mg/0.4 ml, 80 mg/0.8 ml Strengths Only ...... 21 o Hycofenix (Hydrocodone/Pseudoephedrine/Guaifenesin) ...... 21 o Hydrocodone/Homatropine ...... 21 o Morphabond ER (Morphine Sulfate) ...... 21 o Norvir Tablets ...... 21 o Obredon Solution (Hydrocodone/Guaifenesin) ...... 21 o Orfadin (Nitisinone) ...... 21 o Osmolex ER (Amantadine) ...... 21 o Otrexup (Methotrexate Injection) ...... 21 o Prevymis (Letermovir) ...... 22 o Prolastin-C [Alpha1-Proteinase Inhibitor [Human)] ...... 22 o Relpax (Eletriptan) (Brand Only) ...... 22 o Reyataz () (Brand Only) ...... 22 o Sublocade (Buprenorphine Extended-Release) ...... 22 o Tamiflu Suspension (Oseltamivir Phosphate) (Brand Only) ...... 22 o Taperdex Pak 6-Day & 12-Day (Dexamethasone) ...... 22 o Tazorac (Tazarotene) ...... 22 o Tazarotene 0.1% Cream (Generic Tazorac) ...... 22 o Trogarzo (Ibalizumab) ...... 23 o Tussionex ...... 23 o Tuzistra XR (Codeine/Chlorpheniramine) ...... 23 o Utibron Neohaler (Indacaterol/Glycopyrrolate) ...... 23 o Viagra (Sildenafil Citrate) (Brand Only) ...... 23 o VPRIV (Velaglucerase) ...... 23 o Xenazine (Tetrabenazine) ...... 24 o Zemaira [Alpha1-Proteinase Inhibitor (Human)] ...... 24 o Zutripo ...... 24  Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines - Effective Jul. 1, 2018 ...... 24  Intravenous Enzyme Replacement Therapy (ERT) for Gaucher Disease - Effective Jul. 1, 2018 ...... 28  Manipulative Therapy - Effective Jul. 1, 2018 ...... 29  Preventive Care Services - Effective Jul. 1, 2018 ...... 31  Radiation Therapy Procedures Requiring Precertification for eviCore healthcare Arrangement - Effective Jul. 1, 2018 ...... 34  Radiopharmaceuticals and Contrast Media - Effective Jul. 1, 2018 ...... 35

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 Specialty Medication Administration - Site of Care Review Guidelines - Effective Jul. 1, 2018 ...... 36  Trogarzo™ (Ibalizumab-Uiyk) - Effective Jul. 1, 2018 ...... 37  White Blood Cell Colony Stimulating Factors - Effective Jul. 1, 2018 ...... 38 RETIRED/REPLACED  Gait Analysis - Effective Jun. 1, 2018 ...... 42 Administrative Policy Updates REVISED  Assignment of Benefits & Balance Billing - Effective Jul. 1, 2018 ...... 43  Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/ Replacements - Effective Jul. 1, 2018...... 48  Precertification Exemptions for Outpatient Services - Effective Jul. 1, 2018 ...... 48 Reimbursement Policy Updates UPDATED  Injection and Infusion Services - Effective Jun. 1, 2018 ...... 50  Physical Medicine & Rehabilitation: Multiple Therapy Procedure Reduction - Effective Jul. 1, 2018 ...... 50  Preventive Medicine and Screening - Effective Jul. 1, 2018 ...... 50  Procedure and Place of Service - Effective Jun. 1, 2018 ...... 50 REVISED  Discontinued Procedure (CES) - Effective Jul. 1, 2018 ...... 50  Preventive Medicine and Screening (CES) - Effective Jul. 1, 2018 ...... 51  Reduced Services (CES) - Effective Jul. 1, 2018 ...... 53  Split Surgical Package (CES) - Effective Jul. 1, 2018 ...... 53  Supply Policy - Effective Jul. 1, 2018 ...... 54

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Assisted Jul. 1, 2018  Updated list of applicable HCPCS codes; added J3590 Administration of Clotting Factors and Coagulant Blood Products Carrier Testing for Jul. 1, 2018  Updated coverage rationale; replaced language indicating: Genetic Diseases o “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically necessary” o “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven and/or not medically necessary”  Updated list of applicable CPT codes; removed 81228 and 81229 Cosmetic and Jul. 1, 2018  Updated definitions: Reconstructive o Added definition of “Adjacent Tissue Transfer” Procedures o Replaced references to “Functional/Physical Impairment” with “Functional or Physical Impairment”  Updated list of applicable CPT codes that may be cosmetic (review is required to determine if considered cosmetic or reconstructive); added 14000, 14001, 14020, 14021, 14040, 14041, 14060, 14061, 14301, and 14302

Gastrointestinal Jul. 1, 2018  Updated coverage rationale: Motility Disorders, o Replaced language indicating: Diagnosis and . “[The listed services] are proven and medically necessary” with “[the listed services] are proven and/or Treatment medically necessary” . “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven and/or not medically necessary” o Replaced references to “patient” with “member”  Updated supporting information to reflect the most current description of services, clinical evidence, FDA information, and references

Gynecomastia Jun. 1, 2018  Replaced references to “Functional/Physical Impairment” with “Functional or Physical Impairment” Treatment  Updated supporting information to reflect the most current references Intrauterine Fetal Jun. 1, 2018  Updated coverage rationale: Surgery o Replaced language indicating: . “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically necessary” . “[The listed service] is unproven and not medically necessary” with “[the listed service] is unproven and/or not medically necessary” o Replaced references to “in utero fetal surgery” with “intrauterine fetal surgery”  Updated supporting information to reflect the most current description of services, clinical evidence, and

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Intrauterine Fetal Jun. 1, 2018 references Surgery (continued) Macular Jul. 1, 2018  Replaced references to “patient” with “individual” Degeneration  Updated coverage rationale; replaced language indicating: Treatment o “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically Procedures necessary” o “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven and/or not medically necessary”  Updated list of applicable CPT codes; added 67036  Updated supporting information to reflect the most current description of services, clinical evidence, FDA information, and references

Mifeprex® Jun. 1, 2018  Routine review; no content changes (Mifepristone) Molecular Oncology Jul. 1, 2018  Updated list of applicable CPT codes: Testing for Cancer o Added 0022U Diagnosis, o Removed 81228 and 81229 Prognosis, and o Corrected typographical error in description for 0012M; replaced reference to “XCR2” with “CXCR2” Treatment Decisions Occipital Neuralgia Jul. 1, 2018  Updated coverage rationale; replaced language indicating: and Headache o “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically Treatment necessary” o “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven and/or not medically necessary”  Updated list of applicable HCPCS codes; removed E0720 and L8683  Updated supporting information to reflect the most current clinical evidence and references

Prolotherapy for Jun. 1, 2018  Updated non-coverage rationale; replaced language indicating “[the listed service] is unproven and not medically Musculoskeletal necessary” with “[the listed service] is unproven and/or not medically necessary” Indications  Updated supporting information to reflect the most current clinical evidence and references

Repository Jun. 1, 2018  Updated supporting information to reflect the most current clinical evidence, FDA information, and references; Corticotropin no change to coverage rationale or lists of applicable codes Injection (H.P. Acthar Gel®)

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Routine Foot Care Jul. 1, 2018  Updated and reformatted list of applicable CPT/HCPCS codes; modified notations pertaining to Routine Foot Care and Nail Trimming, Cutting, or Debriding to clarify the codes listed in the policy are: o Covered for all diagnoses that are listed on the Covered Diagnosis Codes tab of the Foot Care ICD-10 Diagnosis Codes list (attachment file) o Excluded for all diagnoses that are not listed on the Covered Diagnosis Codes tab of the Foot Care ICD-10 Diagnosis Codes list (attachment file)  Updated and reformatted list of applicable/covered ICD-10 diagnosis codes (attachment file): o Combined content from multiple tabs into a single list of Covered Diagnosis Codes o Added O24.011, O24.012, O24.013, O24.019, O24.02, O24.03, O24.111, O24.112, O24.113, O24.119, O24.12, O24.13, O24.311, O24.312, O24.313, O24.319, O24.32, O24.33, O24.811, O24.812, O24.813, O24.819, O24.82, and O24.83 o Removed B35.3, L60.1, L60.2, L60.3, L60.4, L60.5, L60.8, L62, L84, M21.6X1, M21.6X2, and M21.6X9

Transpupillary Jun. 1, 2018  Updated coverage rationale: Thermotherapy o Replaced language indicating: . “[The listed service] is proven and medically necessary” with “[the listed service] is proven and/or medically necessary” . “[The listed service] is unproven and not medically necessary” with “[the listed service] is unproven and/or not medically necessary” o Replaced reference to “patients” with “individuals”  Updated supporting information to reflect the most current clinical evidence and references

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED ® Alpha1-Proteinase Jul. 1, 2018  Updated list of related policies; Alpha1-proteinase inhibitors (Aralast NP™, Glassia™, Prolastin -C Inhibitors added reference link to the and Zemaira®) are proven and medically necessary for chronic policy titled Specialty Medication augmentation and maintenance therapy of patients with emphysema Administration - Site of Care due to congenital deficiency of alpha1-proteinase inhibitor (A1-PI), Review Guidelines also known as alpha1-antitrypsin (AAT) deficiency.  Revised conditions of coverage/precertification The treatment of emphysema due to congenital deficiency of alpha1- requirements; added language proteinase inhibitor (A1-PI) in patients who meet all of the following to indicate: criteria:

o Additional precertification  For initial therapy, all of the following: requirements apply to o Diagnosis of congenital alpha1-antitrypsin deficiency confirmed by requests for hospital one of the following: outpatient facility infusion of . Pi*ZZ, Pi*Z(null) or Pi*(null)(null) protein phenotypes alpha1-proteinase inhibitors (homozygous); or (Aralast N, Glassia,

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED

Alpha1-Proteinase Jul. 1, 2018 Prolastin-C and Zemaira); . Other rare AAT deficiency disease-causing alleles associated with Inhibitors refer to the policy titled serum alpha1-antitrypsin (AAT) level < 11 µmol/L [e.g., (continued) Specialty Medication Pi(Malton, Malton)] Administration - Site of Care and Review Guidelines o Circulating serum concentration of AAT level < 11 µmol/L (which corresponds to < 80 mg/dl if measured by radial immunodiffusion or < 57 mg/dl if measured by nephelometry); and o Continued optimal conventional treatment for emphysema (e.g., bronchodilators, supplemental oxygen if necessary); and o Current nonsmoker; and o Diagnosis of emphysema confirmed with pulmonary function testing; and o Dosing is in accordance with the United States Food and Drug Administration approved labeling: dosage is 60 mg/kg body weight administered once weekly; and o Initial authorization will be for no more than 12 months.

 For continuation therapy, all of the following: o Diagnosis of congenital alpha1-antitrypsin deficiency confirmed by one of the following: . Pi*ZZ, Pi*Z(null) or Pi*(null)(null) protein phenotypes (homozygous); or . Other rare AAT deficiency disease-causing alleles associated with serum alpha1-antitrypsin (AAT) level < 11 µmol/L [e.g., Pi(Malton, Malton)] and o Submission of medical records (e.g., chart notes, laboratory values) documenting a positive clinical response from pretreatment baseline to alpha1-proteinase inhibitor treatment; and o Current nonsmoker; and o Diagnosis of emphysema confirmed with pulmonary function testing; and o Dosing is in accordance with the United States Food and Drug Administration approved labeling: dosage is 60 mg/kg body weight administered once weekly; and o Reauthorization will be for no more than 12 months.

Alpha1-proteinase inhibitor is unproven and not medically necessary for:

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED

Alpha1-Proteinase Jul. 1, 2018  Conditions other than emphysema associated with alpha1-antitrypsin Inhibitors deficiency (continued)  Cystic fibrosis

Clotting Factors Jul. 1, 2018  Revised coverage rationale: Refer to the policy for complete details on the coverage guidelines for and Coagulant o Updated list of applicable Clotting Factors and Coagulant Blood Products. Blood Products products; added bispecific factor IXa- and factor X- directed antibody [Hemlibra® (emicizumab-kxwh)] o Updated coverage criteria for: Von Willebrand Disease (VWD) . Added language to indicate factor VIII (plasma-derived)/von Willebrand Factor Complex (plasma- derived) [Wilate] is proven and medically necessary when both of the following criteria are met: - Diagnosis of von Willebrand disease; and - One of the following:  Treatment of spontaneous or trauma induced bleeding episodes; or  Peri-operative management of surgical bleeding . Removed language indicating factor VIII (plasma-derived)/von Willebrand Factor

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Clotting Factors Jul. 1, 2018 Complex (plasma- and Coagulant derived) [Wilate] is Blood Products proven and medically (continued) necessary when one of the following criteria is met: - Both of the following:  Diagnosis of severe von Willebrand disease; and  Treatment of spontaneous or trauma-induced bleeding episodes; or - Both of the following:  Diagnosis of mild or moderate von Willebrand disease; and  History of failure, contraindication or intolerance to treatment with Desmopressin Hemophilia A . Added language to indicate emicizumab- kxwh [Hemlibra] is proven and medically necessary when all of the following criteria are met (please note that emicizumab-kxwh [Hemlibra] is a self-

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Clotting Factors Jul. 1, 2018 injectable medication and Coagulant that should be obtained Blood Products under the member’s (continued) pharmacy benefit unless the following criteria is met): - Diagnosis of hemophilia A; and - Patient has developed high-titer factor VIII inhibitors (> 5 Bethesda units [BU]); and - Prescribed for the prevention of bleeding episodes (i.e., routine prophylaxis); and - One of the following:  Patient is less than 7 years of age; or  Patient is 7 years of age or older and cannot self- inject and does not have a caretaker who can be trained to administer emicizumab- kxwh  Updated list of applicable HCPCS codes; added J3590  Updated supporting information to reflect the most current background information, FDA information, and references

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Denosumab Jun. 1, 2018 Notice of Revision: The following Please refer to the policy titled Injectable Chemotherapy Drugs: Application (Prolia® & Xgeva®) summary of changes has been of NCCN Clinical Practice Guidelines for updated information based upon the modified. Revisions to the original National Comprehensive Cancer Network (NCCN) Drugs & Biologics policy update announcement are Compendium® (NCCN Compendium®) for oncology indications. outlined in red below. Please take note of the additional updates to be This policy refers to the following denosumab products: implemented on Jun. 1, 2018.  Prolia  Xgeva  Updated list of related policies; added reference link to the Proven policy titled Injectable Prolia (denosumab) is proven and medically necessary for: Chemotherapy Drugs: Application of NCCN Clinical  The treatment of postmenopausal patients with osteoporosis, or Practice Guidelines to increase bone mass in patients with osteoporosis at high risk  Revised conditions of for fracture who meet ALL of the following criteria: coverage/precertification o Diagnosis of osteoporosis; and requirements to indicate: o One of the following: o Precertification with review . BMD T-score ≤ -2.5 based on BMD measurements from lumbar by a Medical Director or their spine (at least two vertebral bodies), hip (femoral neck, total designee is required for hip), or radius (one-third radius site); or non-oncology indications . History of one of the following resulting from minimal trauma: o All precertification requests - Vertebral compression fracture for oncology indications are - Fracture of the hip handled by eviCore - Fracture of the distal radius healthcare - Fracture of the pelvis  Revised coverage rationale: - Fracture of the proximal humerus o Added instruction to refer to or the policy titled Injectable . Both of the following: Chemotherapy Drugs: - BMD T-score between -1 and -2.5 (BMD T-score greater Application of NCCN Clinical than-2.5 and less than or equal to -1) based on BMD Practice Guidelines for measurements from lumber spine (at least two vertebral updated information based bodies), hip (femoral neck, total hip), or radius (one-third upon the National radius site); and Comprehensive Cancer - One of the following: Network (NCCN) Drugs &  FRAX 10-year fracture probabilities: major osteoporotic ® Biologics Compendium fracture at 20% or more ® (NCCN Compendium ) for  FRAX 10-year fracture probabilities: hip fracture at 3% or oncology indications more; and o Added language to indicate and

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Denosumab Jun. 1, 2018 precertification requests for o History of failure, contraindication, or intolerance to oral or (Prolia® & Xgeva®) oncology indications are intravenous bisphosphonate therapy; and (continued) handled by eviCore o Prolia dosing is in accordance with the United States Food and Drug healthcare; for Administration approved labeling: maximum dosing of 60 mg every 6 precertification information, months; and refer to the policy titled o Authorization is for no more than 12 months. Injectable Chemotherapy Drugs: Application of NCCN  To increase bone mass in patients at high risk for fracture Clinical Practice Guidelines receiving androgen deprivation therapy for non-metastatic prostate cancer in patients who meet ALL of the following criteria: Note: All precertification requests for oncology indications are handled by eviCore healthcare. For precertification information, refer to the policy titled Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines. o Diagnosis of non-metastatic prostate cancer; and o Patient is receiving androgen deprivation therapy; and o History of failure, contraindication, or intolerance to oral or intravenous bisphosphonate therapy; and o Prolia dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 60 mg every 6 months; and o Authorization is for no more than 12 months.

 To treat patients at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer in patients who meet ALL of the following criteria: Note: All precertification requests for oncology indications are handled by eviCore healthcare. For precertification information, refer to the policy titled Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines. o Diagnosis of breast cancer; and o Patient is receiving aromatase inhibitor therapy; and o History of failure, contraindication, or intolerance to oral or intravenous bisphosphonate therapy; and o Prolia dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 60 mg every 6 months; and o Authorization is for no more than 12 months.

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Denosumab Jun. 1, 2018 Xgeva (denosumab) is proven and medically necessary for: (Prolia® & Xgeva®) (continued)  The prevention of skeletal-related events in patients with multiple myeloma and with bone metastases from solid tumors when ALL of the following criteria are met: Note: All precertification requests for oncology indications are handled by eviCore healthcare. For precertification information, refer to the policy titled Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines. o Patient is one of the following: . Patient is ≥ 18 years of age; or . Patient is a skeletally mature adolescent as defined by having at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus) and o One of the following: . Diagnosis of multiple myeloma; or . Presence of metastatic disease secondary to a solid tumor (e.g., bladder, kidney, lung, ovarian, thyroid, etc.) and o Individual has an expected survival of 3 months or greater; and o Refractory (within the past 30 days), contraindication (including renal insufficiency), or intolerance to treatment with intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid) ; and o Xgeva dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 120 mg every 4 weeks; and o Authorization is for no more than 12 months.

 The treatment of giant cell tumor of the bone when ALL of the following criteria are met: Note: All precertification requests for oncology indications are handled by eviCore healthcare. For precertification information, refer to the policy titled Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines. o Patient is one of the following: . Patient is ≥ 18 years of age; or . Patient is a skeletally mature adolescent as defined by having at least 1 mature long bone (e.g., closed epiphyseal growth plate of

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Denosumab Jun. 1, 2018 the humerus) (Prolia® & Xgeva®) and (continued) o Diagnosis of localized or metastatic giant cell tumor of the bone; and o Disease is one of the following: . Unresectable; or . Surgical resection is likely to result in severe morbidity and o Xgeva dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 120 mg every 4 weeks (additional 120 mg doses allowed on Day 8 and 15 in the first month of therapy); and o Authorization is for no more than 12 months.

 The treatment of hypercalcemia of malignancy when ALL of the following criteria are met: Note: All precertification requests for oncology indications are handled by eviCore healthcare. For precertification information, refer to the policy titled Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines. o Patient is one of the following: . Patient is ≥ 18 years of age; or . Patient is a skeletally mature adolescent as defined by having at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus) and o Diagnosis of hypercalcemia of malignancy as defined as: albumin- corrected serum calcium level greater than 12.5 mg/dL (3.1 mmol/L); and o No pre-existing hypocalcemia (i.e., serum calcium or corrected calcium within normal limits per laboratory reference); and o Refractory (within the past 30 days), contraindication (including renal insufficiency), or intolerance to treatment with intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid); and o Xgeva dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 120 mg every 4 weeks (additional 120 mg doses allowed on Day 8 and 15 in the first month of therapy); and o Authorization is for no more than 12 months.

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Denosumab Jun. 1, 2018 Unproven ® ® (Prolia & Xgeva ) Xgeva is unproven and not medically necessary for the following (continued) indications:  Combination therapy of denosumab and intravenous bisphosphonates  Bone loss associated with hormone-ablation therapy (other than aromatase inhibitors) in breast/prostate cancer  Cancer pain  Central giant cell granuloma  Hyper-parathyroidism  Immobilization hypercalcemia  Osteogenesis imperfecta  Osteopenia

Drug Coverage Jul. 1, 2018  Revised list of medications Refer to the policy for complete details on Drug Coverage Criteria - New and Criteria - New and requiring precertification through Therapeutic Equivalent Medications. Therapeutic the pharmacy benefit manager Equivalent (PBM): Medications o Added Balcotra, Climara (brand only), Effient (brand only), Fosrenol Chewable Tablets (brand only), Humira Prefilled Syringe, Norvir Tablets, Orfadin, Osmolex ER, Relpax (brand only), Reyataz Capsules (brand only), Tamiflu Suspension (brand only), Tazarotene 0.1% Cream (generic Tazorac), Utibron Neohaler, and Viagra (brand only) o Removed Bevyxxa, MorphaBond ER, Otrexup, Prevymis, and Taperdex Pak o Updated formulary alternatives for Clarinex/Desloratidine, Clarinex-D, Exforge, Exforge HCT, Fabior, Genadur Kit, Genotropin and Genotropin

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Drug Coverage Jul. 1, 2018 Miniquick, Gocovri, Criteria - New and Humatrope, Lo Minastrin FE, Therapeutic Metozolv ODT, Norditropin, Equivalent Norditropin Nordiflex, Medications Norditropin Flexpro, (continued) Omnitrope, Ozempic, Retin-A Micro (brand and generic), Retin-A Micro Pump (brand and generic), Saizen, Stiolto Respimat, Twynsta, and Zomacton

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Jun. 1, 2018 Prolia, Xgeva Revised  Revised coverage guidelines to indicate precertification is required Guidelines (Denosumab) through: o Oxford’s Medical Management for all requests for non-oncology indications o eviCore healthcare for all requests for oncology indications  Added eviCore guidelines; refer to eviCore Guidelines: Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines for complete details Drug Coverage Jul. 1, 2018  Revised utilization review guidelines; refer to Utilization Review Guideline: Opioid Overutilization Cumulative Guidelines Drug Utilization Review Criteria for complete details

Aralast NP [Alpha1- Revised  Revised coverage criteria/precertification guidelines; added language to Proteinase Inhibitor indicate: (Human)] o Administration 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 Precertification Guidelines: Specialty Medication Administration – Site of Care Review Guidelines for complete details Balcotra (Ethinyl New  Added language to indicate precertification is required through the Estradiol/Levonorgestrel/ Pharmacy Benefit Manager (PBM) Ferrous Bisglycinate)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Jul. 1, 2018 Bevyxxa (Betrixaban) Revised  Revised coverage criteria/precertification requirements to indicate Guidelines precertification is no longer required (continued)  Removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Buphenyl (Sodium New  Added language to indicate precertification is required through the Phenylbutyrate) Pharmacy Benefit Manager (PBM)  Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Sodium Phenylbutyrate for complete details Cerezyme® Revised  Revised coverage criteria/precertification guidelines; added language to (Imiglucerase) indicate: o Administration 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 Precertification Guidelines: Specialty Medication Administration – Site of Care Review Guidelines for complete details Chemotherapy Updated  Updated list of applicable HCPCS codes; added J0897 (Injectable) Drugs Climara (Brand Only) New  Added language to indicate precertification is required through the (Estradiol) Pharmacy Benefit Manager (PBM)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Codeine/Phenylephrine/ New  Added language to indicate precertification is required through the Promethazine Pharmacy Benefit Manager (PBM)  Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Opioid Containing Cough Medicines for complete details Codeine/Promethazine New  Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)  Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Opioid Containing Cough Medicines for complete details Crinone (Progesterone Revised  Revised coverage criteria/precertification requirements to indicate Gel) precertification is required through the Pharmacy Benefit Manager (PBM)  Added step therapy guidelines; refer to Step Therapy Guidelines: Crinone for complete details  Updated notation pertaining to infertility use to indicate:

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Jul. 1, 2018 Crinone (Progesterone Revised o Coverage is limited to Members with coverage for fertility drugs Guidelines Gel) through their plan; Members that do not have (continued) (continued) fertility drug coverage through their prescription drug plan should refer to their Certificate of Coverage for coverage guidelines Effient (Prasugrel) New  Added language to indicate precertification is required through the (Brand Only) Pharmacy Benefit Manager (PBM)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Elelyso (Taliglucerase Revised  Revised coverage criteria/precertification guidelines; added language to Alfa) indicate: o Administration 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 Precertification Guidelines: Specialty Medication Administration – Site of Care Review Guidelines for complete details Flowtuss (Hydrocodone/ Revised  Added prior authorization/medical necessity guidelines; refer to Prior Guaifenesin) Authorization/Medical Necessity Guidelines: Opioid Containing Cough Medicines for complete details Fosrenol Chewable New  Added language to indicate precertification is required through the Tablets (Lanthanum Pharmacy Benefit Manager (PBM) Carbonate) (Brand Only)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Glassia [Alpha1- Revised  Revised coverage criteria/precertification guidelines; added language to Proteinase Inhibitor indicate: (Human)] o Administration 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 Precertification Guidelines: Specialty Medication Administration – Site of Care Review Guidelines for complete details Hemlibra (Emicizumab- Revised  Revised coverage criteria/precertification requirements to indicate Kxwh) precertification is required through Oxford’s Medical Management  Added precertification guidelines; refer to the following policies for complete details: o Precertification Guidelines: Assisted Administration of Clotting Factors and Coagulant Blood Products o Precertification Guidelines: Clotting Factors and Coagulant Blood Products

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Jul. 1, 2018 Hemophilia Drugs Revised  Revised list of applicable brand name drugs; added Hemlibra Guidelines Humira (Adalimumab) New  Added language to indicate precertification is required through the (continued) 10 mg/0.1 ml, 20 Pharmacy Benefit Manager (PBM) mg/0.2ml, 40 mg/0.4  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent ml, 80 mg/0.8 ml Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Strengths Only Medications for complete details Hycofenix Revised  Added prior authorization/medical necessity guidelines; refer to Prior (Hydrocodone/ Authorization/Medical Necessity Guidelines: Opioid Containing Cough Pseudoephedrine/ Medicines for complete details Guaifenesin) Hydrocodone/ New  Added language to indicate precertification is required through the Homatropine Pharmacy Benefit Manager (PBM)  Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Opioid Containing Cough Medicines for complete details Morphabond ER Revised  Removed therapeutic equivalent guidelines and corresponding reference (Morphine Sulfate) link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Norvir Tablets New  Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Obredon Solution Revised  Added prior authorization/medical necessity guidelines; refer to Prior (Hydrocodone/ Authorization/Medical Necessity Guidelines: Opioid Containing Cough Guaifenesin) Medicines for complete details  Updated step therapy guidelines; refer to Step Therapy Guidelines: Obredon for complete details Orfadin (Nitisinone) Revised  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Osmolex ER New  Added language to indicate precertification is required through the (Amantadine) Pharmacy Benefit Manager (PBM)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Otrexup (Methotrexate Revised  Removed therapeutic equivalent guidelines and corresponding reference Injection) link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Jul. 1, 2018 Prevymis (Letermovir) Revised  Revised coverage criteria/precertification requirements to indicate Guidelines precertification is no longer required (continued)  Removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Prolastin-C [Alpha1- Revised  Revised coverage criteria/precertification guidelines; added language to Proteinase Inhibitor indicate: [Human)] o Administration 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 Precertification Guidelines: Specialty Medication Administration – Site of Care Review Guidelines for complete details Relpax (Eletriptan) Revised  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent (Brand Only) Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details  Updated medication/drug name to include “brand only” Reyataz (Atazanavir) New  Added language to indicate precertification is required through the (Brand Only) Pharmacy Benefit Manager (PBM)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Sublocade Revised  Revised coverage criteria/precertification requirements to indicate (Buprenorphine precertification is required through Oxford’s Medical Management Extended-Release) Tamiflu Suspension New  Added language to indicate precertification is required through the (Oseltamivir Phosphate) Pharmacy Benefit Manager (PBM) (Brand Only)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Taperdex Pak 6-Day & Revised  Revised coverage criteria/precertification requirements to indicate 12-Day precertification is no longer required (Dexamethasone)  Removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Tazorac (Tazarotene) Updated  Updated medication/drug name; corrected spelling for “tazarotene” Tazarotene 0.1% Cream New  Added language to indicate precertification is required for Members over (Generic Tazorac) 30 years of age through the Pharmacy Benefit Manager (PBM)  Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tazorac (Tazarotene) for complete

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Jul. 1, 2018 Tazarotene 0.1% Cream New details Guidelines (Generic Tazorac)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent (continued) (continued) Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Trogarzo (Ibalizumab) Revised  Revised coverage criteria/precertification guidelines; added language to indicate: o Precertification is required through Oxford’s Medical Management o Administration 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 Precertification Guidelines: Specialty Medication Administration – Site of Care Review Guidelines for complete details Tussionex New  Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)  Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Opioid Containing Cough Medicines for complete details Tuzistra XR (Codeine/ Revised  Added prior authorization/medical necessity guidelines; refer to Prior Chlorpheniramine) Authorization/Medical Necessity Guidelines: Opioid Containing Cough Medicines for complete details Utibron Neohaler Revised  Revised coverage criteria/precertification requirements to indicate (Indacaterol/ precertification is required through the Pharmacy Benefit Manager (PBM) Glycopyrrolate)  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details Viagra (Sildenafil New  Added language to indicate precertification is required for Members over Citrate) (Brand Only) 30 years of age through the Pharmacy Benefit Manager (PBM)  Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Erectile Dysfunction Agents for complete details  Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details VPRIV (Velaglucerase) Revised  Revised coverage criteria/precertification guidelines; added language to indicate: o Precertification through Oxford’s Medical Management is required for services provided in a hospital outpatient facility setting only o Administration in a hospital outpatient facility (including any ambulatory infusion suite associated with the hospital) requires

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Clinical Policy Updates

Policy Title Effective Date Drug/Medication Status Summary of Changes REVISED Drug Coverage Jul. 1, 2018 VPRIV (Velaglucerase) Revised precertification with review by a Medical Director or their designee; Guidelines (continued) refer to Precertification Guidelines: Specialty Medication (continued) Administration – Site of Care Review Guidelines for complete details Xenazine New  Added language to indicate precertification is required through the (Tetrabenazine) Pharmacy Benefit Manager (PBM)  Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tetrabenazine for complete details

Zemaira [Alpha1- Revised  Revised coverage criteria/precertification guidelines; added language to Proteinase Inhibitor indicate: (Human)] o Administration 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 Precertification Guidelines: Specialty Medication Administration – Site of Care Review Guidelines for complete details Zutripo New  Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)  Added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Opioid Containing Cough Medicines for complete details

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Injectable Jul. 1, 2018  Updated list of related policies: Oxford has engaged eviCore healthcare to perform precertification* reviews Chemotherapy o Added reference link to the for injectable chemotherapy drugs administrated by participating providers in Drugs: Application policy titled Denosumab an office, outpatient or home setting to treat a cancer diagnosis. Oxford of NCCN Clinical (Prolia® and Xgeva®) continues to be responsible for claims payment decisions and for appeals. Practice Guidelines o Removed reference link to the policy titled Lemtrada *Note: Precertification is not required for injectable chemotherapy drugs (Alemtuzumab) administrated by a non-participating provider in an office or outpatient  Revised list of injectable setting however precertification will be provided upon request. chemotherapy drugs requiring precertification for oncology All precertification requests for injectable chemotherapy drugs are handled indications: by eviCore healthcare. To obtain precertification for injectable chemotherapy o Added denosumab (J0897), medications providers must contact eviCore healthcare. Providers are belinostat (J9032), encouraged to obtain precertification on line by logging in to blinatumomab (J9039), OxfordHealth.com and selecting the link to the eviCore healthcare (J9271), authorization web site. Providers may also obtain precertification by calling (J9299), and 1-877-773-2884. ramucirumab (J9308)

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Injectable Jul. 1, 2018 o Removed alemtuzumab eviCore healthcare uses the National Comprehensive Cancer Network’s Chemotherapy (J0202) (NCCN) guidelines in their decision making process. These guidelines provide Drugs: Application o Added instruction to refer to independent recommendations for evidence-based cancer treatment. The of NCCN Clinical the policy titled Denosumab guidelines are continually updated to be consistent with the current Practice Guidelines (Prolia and Xgeva) for non- treatment options. Providers and patients may access and view the NCCN (continued) oncology indications for guidelines at NCCN.org. J0897 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 Receptor (CAR)-T Cell products. Coverage determinations are based on the member’s benefits and the OptumHealth Transplant Solutions criteria for covered transplants in 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.

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.

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED

Injectable Jul. 1, 2018 Select ancillary and supportive care medications for oncology conditions have Chemotherapy therapeutically equivalent products available. When a therapeutically Drugs: Application equivalent alternative is available, as determined by the United Healthcare of NCCN Clinical Pharmacy and Therapeutics (P&T) Committee, certain medications may be Practice Guidelines excluded and/or not medically necessary. For purposes of the United (continued) 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 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,

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Injectable Jul. 1, 2018 so panel members have first-hand knowledge of the data. Inevitably, Chemotherapy some recommendations must address clinical situations for which limited Drugs: Application or no data exist. In these instances the congruence of experience-based of NCCN Clinical opinions provides an informed if not confirmed direction for optimizing Practice Guidelines patient care. These recommendations carry the implicit recognition that (continued) 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 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.

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Intravenous Jul. 1, 2018  Updated list of related policies; This policy refers to the following drug products, all of which are intravenous Enzyme added reference link to the enzyme replacement therapies used in the treatment of Gaucher disease: Replacement policy titled Specialty Medication  Cerezyme® (imiglucerase) Therapy (ERT) for Administration - Site of Care  Elelyso® (taliglucerase) Gaucher Disease Review Guidelines  VPRIV®* (velaglucerase)  Revised conditions of coverage/precertification Cerezyme, Elelyso, and VPRIV* are proven and medically necessary requirements: for the treatment of Type 1 Gaucher disease when ALL of the o Replaced language indicating following criteria are met: “precertification is not  Diagnosis of Type 1 Gaucher disease; and required for velaglucerase  Symptomatic disease (e.g., moderate to severe anemia, (VPRIV®)” with thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and “precertification is not  Dose does not exceed 60 units/kg every 2 weeks. required for velaglucerase (VPRIV®) except in a *VPRIV is the preferred enzyme replacement therapy and does not require hospital outpatient facility precertification. setting” o Added language to indicate Cerezyme is proven and medically necessary for the treatment of additional precertification Type 3 Gaucher disease when ALL of the following criteria are met: requirements apply to  Diagnosis of Type 3 Gaucher disease; and requests for hospital  Symptomatic disease (e.g., moderate to severe anemia, outpatient facility infusion of thrombocytopenia, bone disease, hepatomegaly, splenomegaly); and Cerezyme, Elelyso, and  Dose does not exceed 60 units/kg every 2 weeks. VPRIV; refer to the policy titled Specialty Medication Enzyme replacement therapy with Cerezyme is medically necessary Administration - Site of Care for the treatment of Gaucher disease when ONE of the following Review Guidelines criteria is met:  Both of the following: o Diagnosis of Type 1 Gaucher Disease; and o One of the following: . History of failure of VPRIV due to failure to meet clinical goals (e.g., persistent anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly) despite VPRIV therapy . History of failure of VPRIV due to hypersensitivity to VPRIV therapy . Patient is pregnant or breastfeeding . Patient is attempting to become pregnant or  Diagnosis of Type 3 Gaucher disease

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Intravenous Jul. 1, 2018 Enzyme replacement therapy with Elelyso is medically necessary for Enzyme the treatment of Gaucher disease when BOTH of the following Replacement criteria are met: Therapy (ERT) for  Diagnosis of Type 1 Gaucher Disease; and Gaucher Disease  One of the following: (continued) o History of failure of VPRIV due to failure to meet clinical goals (e.g., persistent anemia, thrombocytopenia, bone disease, hepatomegaly, or splenomegaly) despite VPRIV therapy o History of failure of VPRIV due to hypersensitivity to VPRIV therapy

Manipulative Jul. 1, 2018  Updated list of related policies: Manipulative therapy is proven and/or medically necessary for Therapy o Added reference link to the treating musculoskeletal disorders, except as noted below. policy titled Neuropsychological Testing Manipulative therapy is unproven and/or not medically necessary for under the Medical Benefit treating: o Removed reference link to  Non-musculoskeletal disorders, including but not limited to: the policy titled: o Lungs (e.g., asthma) . Gait Analysis o Internal organs (e.g., intestinal) . In-Office Laboratory o Neurological (e.g., headaches) Testing and Procedures o Ear, nose, and throat (e.g., otitis media) List  Temporomandibular joint (TMJ) disorder  Revised coverage rationale:  Scoliosis o Replaced language indicating: Manipulative therapy is unproven and/or not medically necessary for . “[The listed service] is preventive or maintenance care. proven and medically The role of manipulative therapy in preventive or maintenance care has not necessary” with “[the been established in scientific literature. A beneficial impact on health listed service] is proven outcomes has not been established. and/or medically necessary” Craniosacral therapy (cranial manipulation/Upledger technique) or . “[The listed services] are manipulative services that utilize nonstandard techniques including unproven and not but not limited to applied kinesiology, National Upper Cervical medically necessary” Chiropractic Association (NUCCA), and neural organizational with “[the listed technique are unproven and/or not medically necessary for any services] are unproven indication. and/or not medically The role of manipulation for the above has not been established in scientific necessary” literature. A beneficial impact on health outcomes, e.g., improved physical . “Manipulative therapy is function, durable pain relief, has not been established. unproven and not medically necessary for Manipulative therapy is unproven and/or not medically necessary

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Manipulative Jul. 1, 2018 treating non- when ANY of the following apply: Therapy musculoskeletal  The member’s condition has returned to the pre-symptom state. (continued) disorders (e.g., asthma,  Little or no improvement is demonstrated within 30 days of the initial otitis media, infantile visit despite modification of the treatment plan. colic, etc.) and internal  Concurrent manipulative therapy, for the same or similar condition, organ disorders (e.g., provided by another health professional whether or not the healthcare gallbladder, spleen, professional is in the same professional discipline. intestinal, kidney, or lung disorders)” with This policy does not address manipulation under anesthesia; refer to the “manipulative therapy is policy titled Manipulation Under Anesthesia. unproven and/or not medically necessary for treating non- musculoskeletal disorders, including but not limited to lungs (e.g., asthma), internal organs (e.g., intestinal), neurological (e.g., headaches), and ear, nose, and throat (e.g., otitis media)” . “Manipulative therapy is unproven and not medically necessary for treating prevention/maintenance/ custodial care” with “manipulative therapy is unproven and/or not medically necessary for preventive or maintenance care” o Added language to indicate the role of manipulative therapy in preventive or maintenance care has not been established in scientific literature; a beneficial

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Manipulative Jul. 1, 2018 impact on health outcomes Therapy has not been established (continued) o Replaced reference to: . “Scoliosis correction” with “scoliosis” . “Patient’s condition” with “member’s condition”  Updated supporting information to reflect the most current description of services, clinical evidence, FDA information, and references

Preventive Care Jul. 1, 2018  Updated benefit considerations; Refer to the policy for complete details on the coverage guidelines for Services expanded list of acronyms used Preventive Care Services. in the policy to include “WPSI: Women’s Preventive Services Initiative”  Revised coverage rationale; removed duplicative language pertaining to computed tomographic (CT) colonography and screening mammography for adult women  Revised list of applicable procedure and diagnosis codes: o Reformatted the following code lists (transferred content to embedded Excel file format): . Atherosclerosis Diagnosis Code List . Diabetes Diagnosis Code List . Hepatitis C Virus Infection Screening Diagnosis Code List . Pregnancy Diagnosis Code List

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Jul. 1, 2018 Preventive Care Services Services Bacteriuria Screening (continued) o Added CPT codes 87086 and 87088 Behavioral Counseling to Prevent Skin Cancer o Updated service description: . Removed May 2012 USPSTF ‘B’ rating . Added March 2018 USPSTF ‘B’ rating to indicate the USPSTF recommends counseling young adults, adolescents, children, and parents of young children about minimizing exposure to ultraviolet (UV) radiation for persons ages 6 months to 24 years with fair skin types to reduce their risk of skin cancer Screening for Visual Impairment in Children o Updated service description; added Bright Futures recommendation to indicate instrument-based screening is recommended for: . Age 1-5 years: If the screening is available . Age 6 years and older: If unable to test visual acuity monocularly with age appropriate optotypes o Updated preventive benefit instructions for CPT codes

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Jul. 1, 2018 99173, 99174, and 99177; Services changed benefit age limit (continued) from “less than age 6 years (ends on 6th birthday)” to “up to age 21 years (ends on 21st birthday)” Screening for Visual Impairment in Children (Bright Futures) (new to policy) o Added instruction to refer to the Screening for Visual Impairment in Children section of the policy in combination with the applicable USPSTF recommendation Preventive Immunizations o Updated category description/immunization abbreviations for: . Meningococcal: Added “MenB” . Rotavirus: Added “RV1” and “RV5” o Updated list applicable of CPT codes for Hepatitis B: . Added 90739 (HEPLISAV-B®) with benefit age limit of 18 years and older . Replaced references to “Energix-B®” with “Engerix-B®” o Updated list of applicable trade names for Seasonal Influenza (‘flu”): . CPT code 90653: Added Fluad® . CPT code 90685:

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Preventive Care Jul. 1, 2018 Replaced “Fluzone®” with Services “Fluzone® Quadrivalent” (continued)  Removed USPSTF Grade Definitions (refer to http://www.uspreventiveservices taskforce.org/Page/Name/grade- definitions for applicable information)  Updated supporting information to reflect the most current references Radiation Therapy Jul. 1, 2018  Updated definitions; added Oxford has engaged eviCore healthcare to perform initial reviews of requests Procedures definition of “Lutathera for precertification and medical necessity reviews. Oxford continues to be Requiring (Lutetium; Lu 177 Dotatate)” responsible for decisions to limit or deny coverage and for appeals. Precertification for  Revised list of applicable HCPCS eviCore healthcare codes requiring precertification: All precertification requests are handled by eviCore healthcare. To obtain Arrangement o Added A9699 with precertification for a course of radiation therapy, please contact via one of corresponding instruction to the two options listed below: refer to the eviCore  Providers can call eviCore healthcare at (877)-PRE-AUTH (1-877-773- healthcare website for 2884); or evidence-based guidelines  Providers can log onto the eviCore healthcare website using the Prior and management criteria for Authorization and Notification App. the use of Lutathera as part of a radiation treatment plan Note: It is eviCore healthcare’s policy not to accept precertification requests from persons or entities other than referring physicians for Radiation Therapy services.

eviCore healthcare has established correct coding and evidence-based guidelines to determine the medical necessity and appropriate billing of radiation oncology services. These guidelines have been carefully researched and are continually updated in order to be consistent with the most current evidence-based guidelines and recommendations for the provision of radiation therapy from national and international medical societies and evidence-based medicine research centers. In addition, the criteria are supplemented by information published in peer reviewed literature.

The radiation therapy evidence-based guidelines and management criteria are available on the eviCore healthcare website: https://www.evicore.com/resources/pages/providers.aspx. Additionally,

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Radiation Therapy Jul. 1, 2018 eviCore healthcare has established Radiation Therapy Coding guidelines Procedures which may be referenced while seeking reimbursement for specific radiation Requiring therapy treatment. The eviCore healthcare Radiation Therapy Coding Precertification for Guidelines can also be found on the eviCore healthcare website: eviCore healthcare https://www.evicore.com/resources/pages/providers.aspx?solution=Radiatio Arrangement n%20Therapy#ReferenceGuidelines. (continued) Radiation therapy services are typically delivered as an "episode of care," outlined in detail in a radiation therapy treatment plan written before the patient receives the first dose of radiation.

Providers of radiation therapy services are required to submit a treatment and billing plan for the episode of treatment after the initial clinical evaluation of the member by the treating radiation oncologist and radiation therapy team, and prior to initiating therapy. The treating provider may be asked to submit a clinical submission form. The following information/documentation may be required:  Copies of office notes and treatment planning documents.  Results of key diagnostic studies such as pathology reports, MRI, CT or bone scan.

In conjunction with board certified radiation oncologists, eviCore healthcare staff will evaluate the submitted treatment and billing plans. Providers will be informed, in writing, as to which elements have been approved for payment. Oxford continues to be responsible for decisions to limit or deny coverage and for appeals.

Where provided by state regulations, a board certified radiation oncologist will be available to discuss the payment decision with the treating radiation oncologist.

Radiopharma- Jul. 1, 2018  Revised list of applicable HCPCS Refer to the policy for complete details on the coverage guidelines for ceuticals and codes requiring precertification: Radiopharmaceuticals and Contrast Media. Contrast Media  Added A9699 with corresponding instruction to refer to the policy titled Radiation Therapy Procedures Requiring Precertification for eviCore Healthcare Arrangement for additional information on the use

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Radiopharma- Jul. 1, 2018 of Lutathera (Lutetium; Lu 177 ceuticals and dotatate) as part of a radiation Contrast Media treatment plan (continued) Specialty Jul. 1, 2018  Updated list of related policies; This policy addresses the criteria for consideration of allowing hospital Medication added reference link to the outpatient facility specialty medication infusion services. This includes claim Administration - policy titled: submission for hospital based services with the following CMS/AMA Place of Site of Care Review o Alpha1 Proteinase Inhibitors Service codes: Guidelines o Intravenous Enzyme  19 Off-Campus - Outpatient Hospital; and Replacement Therapy (ERT)  22 On-Campus - Outpatient Hospital for Gaucher Disease o Trogarzo™ (Ibalizumab) Alternative sites of care, such as non-hospital outpatient infusion, physician  Revised coverage rationale; office, ambulatory infusion or home infusion services are well accepted updated list of applicable places of service for medication infusion therapy. If a patient does not meet specialty medications that criteria for outpatient hospital facility infusion, alternative sites of care may require healthcare provider be used. administration: o Added Aralast NP™ [alpha1 Outpatient hospital facility-based intravenous medication infusion is proteinase inhibitor (A1-PI)], medically necessary for members who meet any of the following Cerezyme® (imiglucerase), criteria (submission of medical records detailing at least one of the Elelyso® (taliglucerase), following criteria is required): ® Glassia™ (A1-PI), Prolastin -  Medically unstable based upon submitted clinical history; or C™ (A1-PI), Trogarzo™  Initial medication infusion of or re-initiation after more than 6 months (ibalizumab), VPRIV® following discontinuation of therapy; or (velaglucerase), and  Previous experience of a severe adverse event following infusion. ® Zemaira (A1-PI) Examples include but are not limited to anaphylaxis, seizure,  Updated supporting information thromboembolism, myocardial infarction, renal failure; or to reflect the most current  Continuing experience of adverse events that cannot be mitigated by clinical evidence and references pre-medications or infusion rate adjustments; or  Physically and/or cognitively impaired and no home caregiver available; or  Difficulty establishing and maintaining patent vascular access; or  Homecare or infusion provider has deemed that the patient, home caregiver, or home environment is not suitable for home infusion therapy.

This policy applies to these specialty medications that require healthcare provider administration:  Aralast NP™ (A1-PI)

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Specialty Jul. 1, 2018  Actemra® () Medication  Cerezyme® (Imiglucerase) Administration -  Elelyso® (Taliglucerase) Site of Care Review  Entyvio® () Guidelines  Exondys 51™ (eteplirsen) (continued)  Glassia™ (A1-PI)  Ilaris® ()  Inflectra™ (-dyyb)  Ocrevus™ ()  Orencia® (abatacept) ®  Prolastin -C™ (A1-PI)  Radicava™ (edaravone)  Remicade® (infliximab)  Renflexis™ (infliximab-abda)  Simponi® Aria™ ()  Soliris® ()  Trogarzo™ (Ibalizumab)  VPRIV® (Velaglucerase) ®  Zemaira (A1-PI)

Medical necessity criteria for administration of intravenous infusion therapy at home are addressed in MCG™ Care Guidelines, 22nd edition, 2018, Home Infusion Therapy, CMT: CMT-0009(SR).

Trogarzo™ Jul. 1, 2018 Notice of Revision: The following Trogarzo (ibalizumab-uiyk) is proven and/or medically necessary for (Ibalizumab-Uiyk) summary of changes has been the treatment of multi-drug resistant human immunodeficiency virus modified. Revisions to the original (HIV) in patients who meet ALL of the following criteria: policy update announcement are outlined in red below. Please take  For initial therapy, all of the following: note of the additional updates to be o Both of the following: implemented on Jul. 1, 2018. . Diagnosis of HIV-1 infection . Physician attestation that the patient has multi-drug resistant  Updated list of related policies; HIV-1 infection removed reference link to the and policy titled Review at Launch for o Physician confirms that the patient has been prescribed an optimized New to Market Medications backround antiretroviral regimen, containing at least one  Revised conditions of antiretroviral agent that demonstrates full viral coverage/precertification sensitivity/susceptibility; and requirements to indicate: o Ibalizumab initial and maintenance dosing is in accordance with the o Precertification with review US Food and Drug Administration prescribing information: A single

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED Trogarzo™ Jul. 1, 2018 by a Medical Director or their loading dose of 2,000mg intravenously (IV) followed by a (Ibalizumab-Uiyk) designee is required maintenance dose of 800mg IV every two weeks thereafter; and (continued) o Additional precertification o Initial authorization is for no more than 6 months. requirements apply to requests for hospital  For continuation therapy, all of the following: outpatient facility infusion of o Patient has previously received treatment with ibalizumab; and Trogarzo; refer to the policy o Physician confirms that the patient has achieved a clinically titled Specialty Medication significant viral response to ibalizumab therapy; and Administration - Site of Care o Physician confirms that the patient will continue to take an optimized Review Guidelines backround antiretroviral regimen, in combination with ibalizumab; and o Ibalizumab maintenance dosing is in accordance with the US Food and Drug Administration prescribing information; and o Authorization is for no more than 12 months.

White Blood Cell Jul. 1, 2018  Revised coverage rationale: The policy refers to the following drug products: White Blood Cell Colony Colony Stimulating o Updated coverage criteria for Stimulating Factors (CSFs). Factors Hepatitis-C treatment  Granix related neutropenia  Leukine (Neupogen) [off-label];  Neulasta replaced criterion requiring  Neupogen “medication is prescribed by  Zarxio or in consultation with a hematologist or oncologist” Oxford has engaged eviCore healthcare to perform precertification reviews with “medication is for White Blood Cell Colony Stimulating Factors (CSFs) administrated by prescribed by or in participating providers in an office, outpatient or home setting. Oxford consultation with a continues to be responsible for claims payment decisions and for appeals. hematologist, oncologist, infectious disease specialist, Note: Precertification is not required for White Blood Cell (CSFs) hepatologist, or administrated by a non-participating provider in an office, outpatient setting gastroenterologist” however precertification will be provided upon request.  Updated supporting information to reflect the most current All precertification requests for White Blood Cell (CSFs) are handled by references eviCore healthcare. To obtain precertification white blood cell CSFs providers must contact eviCore. 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

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED White Blood Cell Jul. 1, 2018 (NCCN) guidelines in their decision making process. These guidelines provide Colony Stimulating independent recommendations for evidence-based treatment. The guidelines Factors are continually updated to be consistent with the current treatment options. (continued) Providers and patients may access and view the NCCN guidelines at NCCN.org.

For the coverage criteria below, in absence of specified drug products, the term “colony stimulating factors” or “CSFs” will be used in this policy where the coverage criteria apply to all products listed above.

Bone Marrow/Stem Cell Transplant (Leukine, Neupogen, Zarxio) Leukine, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:  One of the following: o Patient has non-myeloid malignancies and is undergoing myeloablative chemotherapy followed by autologous or allogeneic bone marrow transplant (BMT); or o Used for mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; or o Patient has had a peripheral stem cell transplant (PSCT) and have received myeloablative chemotherapy; and  Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and  Prescribed by or in consultation with a hematologist or oncologist.

Acute Myeloid Leukemia (AML) Induction or Consolidation Therapy (Leukine, Neupogen, Zarxio) Leukine, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:  Diagnosis of AML; and  Patient has completed either induction or consolidation chemotherapy; and  Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and  Prescribed by or in consultation with a hematologist or oncologist.

Neutropenia Associated with Cancer Chemotherapy – Dose Dense

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED White Blood Cell Jul. 1, 2018 Chemotherapy (Leukine, Neulasta, Neupogen, Zarxio) Colony Stimulating Leukine, Neulasta, Neupogen and Zarxio are proven and medically Factors necessary when all of the following criteria are met: (continued)  One of the following: o Patient is receiving National Cancer Institute’s Breast Intergroup, INT C9741 dose dense chemotherapy protocol for primary breast cancer; or o Patient is receiving a dose-dense chemotherapy regimen for which the incidence of febrile neutropenia (FN) is unknown; and  Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and  Prescribed by or in consultation with a hematologist or oncologist.

Primary Prophylaxis of Chemotherapy-Induced Febrile Neutropenia (FN) (Granix, Leukine, Neulasta, Neupogen, Zarxio) White blood cell colony stimulating factors are proven and medically necessary when all of the following criteria are met:  One of the following: o Patient is receiving chemotherapy regimen(s) associated with > 20% incidence of FN; or o Both of the following: . Patient is receiving chemotherapy regimen(s) associated with 10- 20% incidence of FN; and . Patient has one or more risk factors associated with chemotherapy-induced infection, FN, or neutropenia (see risk factor list linked to in the Clinical Evidence section of the policy); and  Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and  Prescribed by or in consultation with a hematologist or oncologist.

Secondary Prophylaxis of Febrile Neutropenia (FN) (Granix, Leukine, Neulasta, Neupogen, Zarxio)

White blood cell colony stimulating factors are proven and medically

necessary when all of the following criteria are met:

 Patient is receiving myelosuppressive anticancer drugs associated with

neutropenia (ANC ≤ 500 cells/mm3); and

 Patient has a history of FN during a previous course of chemotherapy;

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED White Blood Cell Jul. 1, 2018 and Colony Stimulating  Medication is dosed in accordance with the United States Food and Drug Factors Administration approved labeling; and (continued)  Prescribed by or in consultation with a hematologist or oncologist.

Treatment of Febrile Neutropenia (Leukine, Neulasta, Neupogen, Zarxio) [off-label] Leukine, Neulasta, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:  Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (ANC ≤ 500 cells/mm3); and  Diagnosis of FN and patient is considered high risk for infection- associated complications; and  Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and  Prescribed by or in consultation with a hematologist or oncologist.

Severe Chronic Neutropenia (SCN) (Neupogen, Zarxio) Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:  Diagnosis of SCN (i.e., congenital, cyclic, and idiopathic neutropenias with chronic ANC ≤ 500 cells/mm3); and  Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and  Prescribed by or in consultation with a hematologist or oncologist.

HIV-Related Neutropenia (Leukine, Neupogen, Zarxio) [off-label]

Leukine, Neupogen and Zarxio are proven and medically necessary

when all of the following criteria are met:

 Diagnosis of HIV infection; and

 Patient has an ANC ≤ 1,000 (cells/mm3); and

 Medication is dosed in accordance with the United States Food and Drug

Administration approved labeling; and

 Prescribed by or in consultation with a hematologist, oncologist or

infectious disease specialist.

Hepatitis-C Treatment Related Neutropenia (Neupogen) [off-label]

Neupogen is proven and medically necessary when all of the

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Clinical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale REVISED White Blood Cell Jul. 1, 2018 following criteria are met: Colony Stimulating  One of the following: Factors o All of the following: (continued) . Diagnosis of Hepatitis C virus; and . Patient is undergoing treatment with Peg-Intron (peginterferon alfa-2b) or Pegasys (peginterferon alfa-2a); and . Documentation of neutropenia (ANC ≤ 500 cells/mm3) after dose reduction of Peg-Intron or Pegasys; or o Both of the following: . Documentation of interferon-induced neutropenia (ANC ≤ 500 cells/mm3) due to treatment with Peg-Intron (peginterferon alfa- 2b) or Pegasys (peginterferon alfa-2a); and . One of the following: - Diagnosis of HIV co-infection; or - Status post liver transplant; or - Diagnosis of established cirrhosis; and  Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and  Prescribed by or in consultation with a hematologist, oncologist, infectious disease specialist, hepatologist, or gastroenterologist.

Policy Title Effective Date Summary of Changes RETIRED/REPLACED Gait Analysis Jun. 1, 2018  Policy retired; gait analysis for surgical or clinical decision making no longer requires clinical review

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Assignment of Jul. 1, 2018  Updated definitions; removed Assignment of Benefits Benefits & Balance definition of: Payment to a Non-Participating Provider Billing o Discretionary Health Care Many plans do not allow Assignment of Benefits. However, if a member Services requests that Oxford reimburse a non-Participating Provider directly, Oxford o Non-Discretionary Health will reimburse the non-participating provider as requested. In this instance, Care Services reimbursement will be issued to the non-participating provider, will represent  Revised policy guidelines for the benefit amount payable by Oxford for the service and will be attached to Assignment of Benefits to an Explanation of Benefits (EOB). The member is responsible for making indicate: payment to the non-participating provider for any applicable copay, o Many plans do not allow coinsurance, deductible or other cost-share allowance, according to their Assignment of Benefits; benefit plan. however, if a member requests that Oxford make If Oxford decides to pay a non-participating provider directly, it is not payment directly to a non- waiving its rights. Members should not rely on the direct payment of future participating provider or claims. Oxford reserves the right to reimburse the member directly for facility, Oxford may honor services rendered by a non-participating provider, even in instances where this assignment and issue the member has requested that the non-participating provider be reimbursement as requested reimbursed. In this instance, claim payment will be made directly to the by the member member, instead of the non-participating provider. We will continue to o Oxford reserves the right to reimburse the provider directly when services are provided: reimburse the member  To all New Jersey (NJ) plan members (all plans and products) directly even in instances  By all NJ providers where the member  In an emergency room setting (includes emergency ambulance services) requested the non-  For early intervention services; refer to the policy titled Speech Therapy participating provider be and Early Intervention Program/Birth To Three for additional information. reimbursed; refer to the  To a New York (NY) plan member for a surprise bill when the member Procedures and has signed the New York State Out-of-Network Surprise Medical Bill Responsibilities section [of Assignment of Benefits Form; for additional information refer to our the policy] for additional website for Information for Members in New York Insurance Plans: information Emergency Services and Surprise Bills.  Revised procedures and responsibilities for Assignment Note: Directing claim payment to the member rather than the non- of Benefits: participating provider does not change the determination of coverage, o Modified language pertaining benefit level, or pricing for a non-participating claim, only the recipient of the to Payment to a Non- payment. Participating Provider to indicate: Payment to a Member . Many plans do not allow If a member requests that Oxford reimburse them for services rendered by a Assignment of Benefits; non-participating provider, Oxford will make the claim payment directly to

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Assignment of Jul. 1, 2018 however, if a member the member, as requested. Reimbursement will be issued to the member, Benefits & Balance requests that Oxford will represent the benefit amount payable by Oxford for the service and will Billing reimburse a non- be attached to an EOB. The member will be responsible for making payment (continued) Participating Provider to the non-participating provider for the full amount of the check mailed to directly, Oxford will the member, in addition to any applicable copay, coinsurance, deductible, or reimburse the non- other cost-share allowances, according to their benefit plan. participating provider as requested Exceptions: . In this instance,  All CT fully insured members and members in fully insured Non- reimbursement will be CT plans if the employer has 51% or more of their employees issued to the non- located in the state of CT: A member who recieves services related to participating provider, the diagnosis and/or treatment of a substance use disorder shall be will represent the benefit deemed, by law, to have made an Assignment of Benefits/authorization amount payable by for payment to CT non-participating providers. In this instance, Oxford Oxford for the service will pay the non-participating provider directly. and will be attached to  NY surprise bills: Oxford negotiates and reimburses a non-partcipating an Explanation of provider directly when a member receives a surprise bill and has filled Benefits (EOB) out the New York State Out-of-Network Surprise Medical Bill Assignment . The member is of Benefits Form; for additional information refer to our website for responsible for making Information for Members in New York Insurance Plans: Emergency payment to the non- Services and Surprise Bills. participating provider for any applicable copay, Balance Billing coinsurance, deductible Participating Providers or other cost-share A Participating Provider may balance bill a member when: allowance, according to  Applicable copays, coinsurance and/or permitted deductibles; their benefit plan  A service or item is not a covered benefit (i.e., the service is excluded in . If Oxford decides to pay the "Exclusions and Limitations" section of the member's Certificate of a non-participating Coverage); provider directly, it is not  The benefit limit, if any limit is applicable, is exceeded/exhausted; waiving its rights  Oxford denied a request for precertification (prior to the service being . Members should not rely rendered) and the member proceeded to receive the service anyway; on the direct payment of  Oxford denied a concurrent certification request (i.e., the member is future claims currently receiving the service) and the provider obtained the member's . Oxford reserves the right signature to a clear, written statement acknowledging they would be to reimburse the responsible for the cost of the service, prior to the service being member directly for rendered; or services rendered by a  A member self refers to a provider that does not participate in a non-participating member’s network (i.e., a Liberty member self-refer to a non-Liberty

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Assignment of Jul. 1, 2018 provider, even in Oxford Participating Provider). In this instance, if the provider Benefits & Balance instances where the participates in the W500 Network, the provider may only bill up to their Billing member has requested contracted rate for emergent services. (continued) that the non- participating provider be Other than the situations outlined above, a Participating Provider may not reimbursed balance bill an Oxford member. . In this instance, claim payment will be made Reminders directly to the member,  A Participating Provider (for the member's network) may not balance bill instead of the non- the member for a covered service that was denied by Oxford for participating provider administrative reasons (i.e., because there was no referral or . We will continue to authorization on file with Oxford when one was required, etc.). reimburse the provider  In the event that a member is being inappropriately balance billed by a directly when services provider (see above when providers are authorized to balance bill), the are provided: member has the right to file a complaint or grievance, orally or in - To New Jersey (NJ) writing, regarding the Balance Billing. plan members (all  Participating Providers who repeatedly violate these restrictions on billing plans and products) Oxford members will be subject to discipline up to and including - By NJ providers termination of their provider participation agreement. - In an emergency  If a Participating Provider inappropriately balance bills a member, room setting Oxford will hold the member harmless and pursue the matter directly (includes emergency with the provider. ambulance services) - For early Non-Participating Providers intervention A non-participating provider (i.e., those who are not contracted with Oxford services; refer to the in any way) has the right to balance bill a member at any time with the policy titled Speech following exceptions: Therapy and Early  Non-Participating Covering Physicians: Oxford Participating Intervention Providers are required to have covering physicians who are either Oxford Program/Birth To participating physicians or agree to accept the Oxford rate (and Three for additional applicable Oxford cost share) as payment in full. Therefore, if there is no information Participating Provider available, a "covering" non-participating provider - To a New York (NY) may deliver the service but will be deemed an agent of the participating plan member for a provider and paid the Oxford rate applicable to the Participating Provider surprise bill when for whom they are covering. Non-participating providers in such the member has situations may not balance bill the member for the difference between signed the New York their charges and the participating fee schedule. State Out-of- Note: Oxford must certify any non-participating health care Network Surprise professionals used to provide coverage for a Participating Provider.

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Assignment of Jul. 1, 2018 Medical Bill  Transitional Care Providers: Non-participating providers who treat Benefits & Balance Assignment of Oxford members in a transitional care arrangement may not bill Billing Benefits Form; for members for unpaid charges, except for the instances outlined under the (continued) additional Participating Provider section above. information refer to Information for Reminders Members in New  When a member or an Oxford Participating Provider has received York Insurance authorization from Oxford for a member to be treated by a non- Plans: Emergency participating specialist as an in-plan exception, the member will be held Services and harmless, except for cost share responsibilities as applicable under the Surprise Bills in-network provisions of the member's Certificate. . Directing claim payment  If a non-participating provider inappropriately balance bills a member, to the member rather Oxford will hold the member harmless and pursue the matter directly than the non- with the provider. participating provider does not change the determination of coverage, benefit level, or pricing for a non- participating claim; only the recipient of the payment o Modified language pertaining to Payment to a Member: . Replaced language indicating “if a member elects to assign benefits to himself/herself for services rendered by a non-participating provider, Oxford will make the claim payment directly to the member, as requested” with “if a member requests that Oxford reimburse them for services rendered by a non-participating provider, Oxford will

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Assignment of Jul. 1, 2018 make the claim payment Benefits & Balance directly to the member, Billing as requested” (continued) . Added exception language to indicate claim payment will not be made to the member in the follow scenarios: - CT fully insured members and members in fully insured non-CT plans if the employer has 51% or more of their employees located in the state of CT: A member who receives services related to the diagnosis and/or treatment of a substance use disorder shall be deemed, by law, to have made an assignment of benefits/authorizatio n for payment to CT non-participating providers; in this instance, Oxford will pay the non- participating provider directly - NY surprise bills: Oxford negotiates and reimburses a non-participating

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Assignment of Jul. 1, 2018 provider directly Benefits & Balance when a member Billing receives a surprise (continued) bill and has filled out the New York State Out-of-Network Surprise Medical Bill Assignment of Benefits Form

Durable Medical Jul. 1, 2018  Updated list of related policies; Refer to the policy for complete details on the coverage guidelines for Equipment, added reference link to the Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies Orthotics, Ostomy policy titled Attended and Repairs/ Replacements. Supplies, Medical Polysomnography for Evaluation Supplies and of Sleep Disorders Repairs/  Revised coverage Replacements rationale/indications for coverage; added language pertaining to the evaluation of PAP therapy to indicate hypopnea is defined as an abnormal respiratory event lasting at least 10 seconds associated with at least a 30% reduction in airflow and with at least a 3% decrease in oxygen saturation from pre-event baseline or the event is associated with an arousal

Precertification Jul. 1, 2018  Revised list of applicable CPT Refer to the policy for complete details on Precertification Exemptions for Exemptions for codes for Pathology and Outpatient Services. Outpatient Services Laboratory services that do not require precertification in the office or outpatient setting: o Removed 0022U (refer to the policy titled Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions for

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Administrative Policy Updates

Policy Title Effective Date Summary of Changes Administrative Guidelines REVISED Precertification Jul. 1, 2018 applicable coverage Exemptions for guidelines) Outpatient Services (continued)

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes UPDATED Injection and Jun. 1, 2018  Routine review; no content changes Infusion Services Physical Medicine & Jul. 1, 2018  Updated policy application guidelines; added language to clarify this policy applies to: Rehabilitation: o Services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent Multiple Therapy or its successor form Procedure o All products Reduction Preventive Jul. 1, 2018  Updated list of related policies; added reference link to the policy titled: Medicine and o Add-On Policy Screening o Prolonged Services  Updated reimbursement guidelines; added language to indicate: o According to CPT and HCPCS, prolonged preventive service codes G0513-G0514 are considered add-on codes and should not be reported without the appropriate primary code; refer to the Add-On Policy for details

Procedure and Jun. 1, 2018  Routine review; no content changes Place of Service

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Discontinued Jul. 1, 2018  Revised policy application Under certain circumstances such as a serious risk to the patient's well- Procedure (CES) guidelines: being, a surgical or diagnostic procedure is terminated at the physician, o Added language to indicate hospital, ambulatory surgical center or other health care professional's this policy applies to all direction. Under these circumstances the procedure provided should be products identified by its usual procedure code and the addition of Modifier 53 o Removed language (Discontinued Procedure) signifying that the procedure was started but indicating this policy applies discontinued. This provides a means of reporting the Discontinued Procedure to: leaving the identification of the basic service intact. . Services reported using the UB-04 Claim Form According to the Centers for Medicare & Medicaid Services (CMS) and CPT . Hospitals and coding guidelines, modifier 53 should be used with surgical codes or medical ambulatory surgical diagnostic codes. Modifier 53 should not be used with: centers  Evaluation and management (E/M) services  Elective cancellation of a procedure prior to the patient's anesthesia induction and/or surgical preparation in the operating suite.  When a laparoscopic or endoscopic procedure is converted to an open procedure or when a procedure is changed or converted to a more extensive procedure.

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED

Discontinued Jul. 1, 2018 Oxford’s standard for reimbursement of Discontinued Procedures with Procedure (CES) modifier 53 is 25% of the Allowable Amount for the primary unmodified (continued) procedure. Multiple procedure reductions will still apply.

For procedures that are partially reduced or eliminated at the physician's direction, see the Reduced Services policy (Modifier 52).

Preventive Jul. 1, 2018  Updated list of related policies; Preventive Medicine Service and Problem Oriented E/M Service Medicine and added reference link to the A Preventive Medicine CPT or HCPCS code and a Problem-Oriented E/M CPT Screening (CES) policy titled: code may both be submitted for the same patient by the Same Specialty o Add-On Policy Physician or Other Health Care Professional on the same date of service. If o Prolonged Services the E/M code represents a significant, separately identifiable service and is  Replaced references to “Same submitted with modifier 25 appended, Oxford will reimburse the Preventive Specialty Physician, Hospital, Medicine code plus 50% of the Problem-Oriented E/M code. Oxford will not Ambulatory Surgical Center or reimburse a Problem-Oriented E/M code that does not represent a Other Health Care Professional” significant, separately identifiable service and that is not submitted with with “Same Specialty Physician modifier 25 appended. or Other Health Care Professional” Preventive Medicine Service and Other E/M Service  Revised policy application A Preventive Medicine CPT or HCPCS code and Other E/M CPT or HCPCS guidelines: codes may both be submitted for the same patient by the Same Specialty o Added language to indicate Physician or Other Health Care Professional on the same date of service. this policy applies to all However, Oxford will only reimburse the Preventive Medicine CPT or HCPCS products code. o Removed language indicating this policy applies Screening Services to: The comprehensive nature of a Preventive Medicine code reflects an age and . Services reported using gender appropriate examination. When a screening code is billed with a the UB-04 Claim Form Preventive Medicine code on the same date of service by the Same Specialty . Hospitals and Physician or Other Health Care Professional, only the Preventive Medicine ambulatory surgical code is reimbursed. centers  Updated reimbursement Prolonged Services guidelines; added language to Prolonged services codes represent add-on services that are reimbursed indicate: when reported in addition to an appropriate primary service. Preventive o According to CPT and Medicine Services are not designated as appropriate primary codes for the HCPCS, prolonged Prolonged services codes. When Prolonged service add-on codes are billed preventive service codes with a Preventive Medicine code on the same date of service by the Same G0513-G0514 are Specialty Physician or Other Health Care Professional, only the Preventive

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Preventive Jul. 1, 2018 considered add-on codes and Medicine code is reimbursed. Medicine and should not be reported Screening (CES) without the appropriate According to CPT and HCPCS, prolonged preventive service codes G0513- (continued) primary code; refer to the G0514 are considered add-on codes and should not be reported without the Add-On Policy for details appropriate primary code. Refer to the Add-On Policy for details.

Counseling Services Preventive Medicine Services include counseling. When counseling service codes are billed with a Preventive Medicine code on the same date of service by the Same Specialty Physician or Other Health Care Professional, only the Preventive Medicine code is reimbursed.

Medical Nutrition Therapy Services According to CPT, for Medical Nutrition Therapy assessment and/or intervention performed by a physician, report Evaluation and Management or Preventive Medicine service codes. When Medical Nutrition Therapy codes are billed with a Preventive Medicine code on the same date of service by the Same Specialty Physician or Other Health Care Professional, only the Preventive Medicine code is reimbursed.

Visual Function and Visual Acuity Screening The comprehensive nature of a Preventive Medicine code reflects an age and gender appropriate examination. When Visual Function Screening or Visual Acuity Screening is billed with a Preventive Medicine code on the same date of service by the Same Specialty Physician or Other Health Care Professional, only the Preventive Medicine code is reimbursed.

Modifier Description Significant, separately identifiable evaluation and management service by the Same Physician or Other Qualified Health Care Professional on the same day of the procedure or other service. It may be necessary to indicate that on the day a procedure or service identified 25 by a CPT code was performed, the patient's condition required a significant, separately identifiable E/M service above and beyond the other service provided or beyond the usual preoperative and postoperative care associated with the procedure that was performed.

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Reduced Services Jul. 1, 2018  Revised policy application There are no industry standards for reimbursement of claims billed with (CES) guidelines: Modifier 52 from the Centers for Medicare and Medicaid Services (CMS) or o Added language to indicate other professional organizations. Oxford's standard for reimbursement of this policy applies to all Modifier 52 is 50% of the Allowable Amount for the unmodified procedure. products o Removed language This modifier is not used to report the elective cancellation of a procedure indicating this policy applies before anesthesia induction, intravenous (IV) conscious sedation, and/or to: surgical preparation in the operating suite. . Services reported using the UB-04 Claim Form Modifier 52 should not be used with an evaluation and management (E/M) . Hospitals and service. ambulatory surgical centers

Split Surgical Jul. 1, 2018  Revised policy application Consistent with the Centers for Medicare and Medicaid Services (CMS), Package (CES) guidelines: Oxford considers the surgical care rendered by the Same Group Physician o Added language to indicate and/or Other Health Care Professional to include pre-operative management. this policy applies to all Accordingly, in Split Surgical Package situations, the pre-operative and products surgical care portions of the Surgical Package are combined by Oxford in the o Removed language reimbursement of surgical codes appended with modifier 54. Preoperative indicating this policy applies care is not reimbursed separately. Postoperative care management may be to: reimbursed separately when a physician or other health care professional . Services reported using who is not within the Same Group Practice as the operating physician the UB-04 Claim Form provides the postoperative care as denoted by submission of the surgical . Hospitals and code appended with modifier 55. ambulatory surgical centers Split surgical package situations will be reimbursed not to exceed 100% of the total global surgical allowable amount, and are reimbursable at the percentages indicated:

Modifier Modifier Description Percentage Surgical Care Only (includes preoperative 54 80% and surgical care management)

55 Postoperative Management only 20%

56 Preoperative Management only 0% TOTAL: 100%

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Supply Policy Jul. 1, 2018  Revised Supply Facility J-Code Supply Reimbursement in a Physician’s or Other Qualified Health Denial Code List (attachment file Care Professional’s Office and Other Nonfacility Places of Service listing drug codes that are not Pursuant to Centers for Medicare and Medicaid Services (CMS) policy, certain separately reimbursable in POS HCPCS supply codes are not separately reimbursable as the cost of supplies 19, 21, 22, 23, or 24); removed is incorporated into the Practice Expense Relative Value Unit (RVU) for the J7296 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 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

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Supply Policy Jul. 1, 2018 list and Supply Facility J-Code Denial Code list (see the Attachments section (continued) 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 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 the 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.

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Reimbursement Policy Updates

Policy Title Effective Date Summary of Changes Reimbursement Guidelines REVISED Supply Policy Jul. 1, 2018 Casting and Splint Supplies (continued) 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 included with the office visit or other services rendered (list drugs, trays, supplies, or materials provided) is not reimbursable in any setting.

56 Oxford® Policy Update Bulletin: June 2018