Oxford® Policy Update Bulletin: October 2015 Oxford

Oxford

October 2015

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 updates.*

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

Oxford

Oxford® Medical and Administrative Policy Updates

Overview

This bulletin provides complete details on Oxford® Medical and Policy Update Classifications Administrative Policy updates. The appearance of a service or New procedure in this bulletin indicates only that Oxford® has recently New clinical coverage criteria and/or documentation review requirements adopted a new policy and/or updated, revised, replaced or have been adopted for a service, procedure, test, or device retired an existing policy; it does not imply that Oxford® provides Updated coverage for the service or procedure. In the event of an An existing policy has been reviewed and changes have not been made inconsistency or conflict between the information provided in this to the clinical coverage criteria or documentation review requirements; bulletin and the posted policy, the provisions of the posted policy however, items such as the clinical evidence, FDA information, and/or will prevail. Note that most benefit plan documents exclude from list(s) of applicable codes may have been updated benefit coverage health services identified as investigational or unproven/not medically necessary. Physicians and other health Revised care professionals may not seek or collect payment from a An existing policy has been reviewed and revisions have been made to member for services not covered by the applicable benefit plan the clinical coverage criteria and/or documentation review requirements unless first obtaining the member’s written consent, Replaced acknowledging that the service is not covered by the benefit plan An existing policy has been replaced with a new or different policy and that they will be billed directly for the service. Retired A complete library of Oxford® Medical and Administrative The procedural codes and/or services previously outlined in the policy are Policies is available at OxfordHealth.com > Providers > no longer being managed or are considered to be proven/medically Tools & Resources > Medical Information > Medical and necessary and are therefore not excluded as unproven/not medically Administrative Policies. necessary services, unless coverage guidelines or criteria are otherwise documented in another policy

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

2 Oxford® Policy Update Bulletin: October 2015 Oxford

Oxford® Medical and Administrative Policy Updates

In This Issue

Clinical Policy Updates Page NEW  Follicle Stimulating Hormone (FSH) Gonadotropins - Effective Nov. 1, 2015 ...... 7  Human Menopausal Gonadotropins (hMG) - Effective Nov. 1, 2015 ...... 9 UPDATED  17-Alpha-Hydroxypro-gesterone Caproate (Makena and 17P) - Effective Nov. 1, 2015 ...... 12  Alemtuzumab - Effective Oct. 1, 2015 ...... 14  Core Decompression for Avascular Necrosis - Effective Oct. 1, 2015 ...... 15  Diagnostic (Basic) Procedures for Infertility - Effective Oct. 1, 2015 ...... 16  Embolization of the Ovarian and Iliac Veins for Pelvic Congestion Syndrome - Effective Oct. 1, 2015 ...... 17  Lithotripsy for Salivary Stones - Effective Oct. 1, 2015 ...... 17  Mifeprex (Mifepristone, RU-486) - Effective Oct. 1, 2015 ...... 18  Nerve Graft to Restore Erectile Function During Radical Prostatectomy - Effective Oct. 1, 2015 ...... 19  Presacral Neurectomy and Uterine Nerve Ablation for Pelvic Pain - Effective Oct. 1, 2015 ...... 19  Repository Corticotropin Injection (H.P. Acthar Gel) - Effective Nov. 1, 2015...... 20  Rituxan (Rituximab) - Effective Nov. 1, 2015 ...... 21  Routine Foot Care - Effective Oct. 1, 2015 ...... 23  Sandostatin Lar Depot (Octreotide Acetate) - Effective Nov. 1, 2015 ...... 23  Total Artificial Heart - Effective Oct. 1, 2015 ...... 25  Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Nausea and Vomiting - Effective Oct. 1, 2015 ...... 26  Treatment of Infertility - Effective Oct. 1, 2015 ...... 26  Treatment of Infertility for Connecticut Groups - Effective Oct. 1, 2015 ...... 29  Treatment of Infertility for New Jersey Large Groups - Effective Oct. 1, 2015 ...... 31  Treatment of Infertility for New York Large and Small Groups - Effective Oct. 1, 2015...... 34  Unicondylar Spacer Devices for Treatment of Pain or Disability - Effective Oct. 1, 2015 ...... 36  Vaccines - Effective Oct. 1, 2015 ...... 37  Xolair (Omalizumab) - Effective Nov. 1, 2015 ...... 37 REVISED  Abnormal Uterine Bleeding and Uterine Fibroids - Effective Nov. 1, 2015 ...... 40  Botulinum Toxins A and B - Effective Nov. 1, 2015 ...... 42  Clotting Factors and Coagulant Blood Products - Effective Nov. 1, 2015 ...... 48  Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Nov. 1, 2015 ...... 49

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Oxford® Medical and Administrative Policy Updates

In This Issue

 Drug Coverage Guidelines - Effective Sep. 10, 2015 ...... 49 o Praluent (Alirocumab) ...... 49 o Repatha (Evolocumab) ...... 52  Drug Coverage Guidelines - Effective Oct. 1, 2015 ...... 52 o Actimmune (interferon gamma-1b) ...... 52  Drug Coverage Guidelines - Effective Nov. 1, 2015 ...... 52 o Actimmune (Interferon Gamma-1b) ...... 52 o Afinitor (Everolimus) ...... 53 o Avodart (Dutasteride) ...... 54 o Banzel (Rufinamide) ...... 54 o Berinert (C1 Esterase Inhibitor Human) ...... 54 o Bravelle (Urofollitropin) ...... 54 o Brilinta (Ticagrelor) ...... 54 o Caprelsa (Vandetanib) ...... 54 o Cinryze (C1 Esterase Inhibitor (Human)) ...... 55 o Cometriq (Cabozantinib) ...... 55 o Daklinza (Daclatasvir) ...... 55 o Evista (Raloxifene) (Brand Only) ...... 55 o Finacea 15% Foam (Azelaic Acid) ...... 55 o Firazyr (Icatibant) ...... 55 o Flowtuss (Hydrocodone/Guaifenesin) ...... 56 o Follistim AQ (Follitropin Beta) ...... 56 o Genotropin (Somatropin) ...... 56 o Gonal-F (Follitropin Alfa) ...... 56 o Harvoni ™ (Ledipasvir/Sofosbuvir) ...... 56 o Histex-AC Syrup (Codeine/Phenylephrine/Triprolidine) ...... 60 o Humatrope (Somatropin) ...... 60 o Humira (Adalimumab) ...... 60 o Hycofenix (Hydrocodone/Pseudoephedrine/Guaifenesin) ...... 61 o Inlyta (Axitinib) ...... 61 o Menopur (Menotropins) ...... 61 o Movantik (Naloxegol)...... 62 o Nexavar (Sorafenib Tosylate) ...... 62 o Norditropin AQ (Somatropin) ...... 63 o Norditropin (Somatropin) ...... 63 o Norditropin Nordiflex (Somatropin)...... 64 o Nuspin (Somatropin) ...... 64 o Nutropin and Nutropin AQ (Somatropin) ...... 64 o Olysio (Simeprevir) ...... 65 o Omnitrope (Somatropin) ...... 66

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Oxford® Medical and Administrative Policy Updates

In This Issue

o Onfi (Clobazam) ...... 66 o Oxistat (Oxiconazole Nitrate) ...... 66 o Potiga (Ezogabine) ...... 66 o Repatha (Evolocumab) ...... 66 o Repronex (Menotropins) ...... 66 o Ruconest (C1 Esterase Inhibitor [Recombinant]) ...... 67 o Saizen (Somatropin) ...... 67 o Savaysa (Edoxaban)...... 67 o Serostim (Somatropin) ...... 67 o Soltamox (Tamoxifen Citrate) ...... 67 o Sovaldi (Sofosbuvir) ...... 68 o Sutent (Sunitinib) ...... 69 o Synjardy (Empagliflozin/Metformin Hydrochloride) ...... 70 o Tamoxifen ...... 70 o Technivie (Ombitasvir/Paritaprevir/Ritonavir) ...... 70 o Victrelis (Boceprevir) ...... 71 o Viekira Pak (Ombitasvir, Paritaprevir (ABT-450) and Ritonavir) ...... 71 o Votrient (Pazopanib)...... 72 o Zarxio (Filgrastim-Sndz) ...... 74 o Zecuity 6.5mg/4 Hr Patch (Sumatriptan Iontophoretic) ...... 74 o Zomacton (Somatropin) ...... 74 o Zorbtive (Somatropin) ...... 74  High Frequency Chest Wall Compression Devises - Effective Nov. 1, 2015 ...... 75  Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines - Effective Feb. 1, 2016 ...... 76  Panniculectomy and Body Contouring Procedures - Effective Nov. 1, 2015 ...... 79  Plagiocephaly and Craniosynostosis Treatment - Effective Nov. 1, 2015...... 81 REPLACED  Actimmune (Interferon Gamma-1b) - Effective Oct. 1, 2015 ...... 84  Follicle Stimulating Hormones (FSH) Used in the Treatment of Infertility - Effective Nov. 1, 2015 ...... 84  Human Menopausal Gonadotropins (hMG) Used in the Treatment of Infertility - Effective Nov. 1, 2015 ...... 84 Administrative Policy Updates UPDATED  Orthopedic Services - Effective Oct. 1, 2015 ...... 85 REVISED  Accreditation Requirements for Radiologists and Radiology Centers - Effective Oct. 1, 2015 ...... 86

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Oxford® Medical and Administrative Policy Updates

In This Issue

 Credentialing Guidelines: Participation in the eviCore Healthcare Network - Effective Oct. 1, 2015 ...... 87  Timeframe Standards for Utilization Management (UM) Initial Decisions - Effective Nov. 1, 2015 ...... 88  Transportation Services - Effective Nov. 1, 2015 ...... 88 Reimbursement Policy Updates UPDATED  Maximum Frequency Per Day - Effective Oct. 19, 2015 ...... 96  Reduced Services - Effective Oct. 1, 2015 ...... 101 REVISED  Ambulance Policy - Effective Nov. 1, 2015 ...... 101  Durable Medical Equipment, Orthotics and Prosthetics Multiple Frequency - Effective Nov. 1, 2015 ...... 102  Microsurgery Policy - Effective Nov. 1, 2015...... 106  Obstetrical Policy - Effective Oct. 1, 2015 ...... 107

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Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Follicle Stimulating Nov. 1, 2015 Oxford has engaged Optum to perform reviews of requests for pre-certification (Oxford continues to be responsible Hormone (FSH) for decisions to limit or deny coverage and for appeals). All authorization/pre-certification requests are handled by Gonadotropins Optum. To pre-certify a procedure related to the treatment of infertility, please call Optum at 877-512-9340.

This policy addresses the following gonadotropins:  Bravelle (urofollitropin)  Gonal-f (follitropin alfa)  Follistim AQ (follitropin beta)

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

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

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

The following information pertains to medical necessity review:

A. General Requirements (applicable to all medical necessity requests): 1. For initial and continuation of therapy, all of the following must be met for consideration of treatment: a. Prognosis for conception must be ≥ 5%; and b. Adequate ovarian reserve as indicated but not limited to at least one the following markers (one or more of the following within the previous 6 months: 1. FSH level < 15 mIU/ml if > 35 years of age; or 2. FSH level < 20 mIU/ml if ≤ 35 years of age; or 3. AMH level > 0.3 ng/ml; or 4. Antral follicle count > 6 and c. Evidence of adequate ovarian response to stimulation if there has been previously monitored, medicated- stimulated infertility treatment within the past 6 months. Examples of adequate ovarian response are: 1. One follicle ≥ 15 mm diameter for IUI 2. Minimum of 1 follicle ≥ 15 mm diameter for ART

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Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Follicle Stimulating Nov. 1, 2015 B. Diagnosis-Specific Requirements Hormone (FSH) The information below indicates additional requirements for those indications having specific medical necessity Gonadotropins criteria in the list of proven indications. (continued) FSH gonadotropins are proven and medically necessary for: 1. Ovulation Induction

Gonadotropins are proven and medically necessary for the treatment for females with ovulatory dysfunction when one of the following criteria are met: a. Anovulation; or b. Oligo-ovulation; or c. All of the following: 1. Amenorrhea; and 2. Other specific causative factors (e.g., thyroid disease, hyperprolactinemia) have been excluded or treated; and 3. Failure to ovulate with either Clomid (clomiphene citrate) or Femara (letrozole) and d. One of the following: 1. For assisted reproductive technologies (ART), dose does not exceed 450 IU/day, for no more than 14 days per cycle; or 2. For ovulation induction, dose does not exceed 150 IU/day, for no more than 14 days per cycle.

Gonadotropins are unproven and not medically necessary for females with ovulatory dysfunction in the following situations: th a. Beyond the 6 gonadotropin induced ovulatory cycle. b. When there are ≥ 4 follicles which are ≥15 mm in diameter from a previously gonadotropin-induced ovulation, despite a dosage adjustment (e.g., doses of gonadotropin down to 37.5 IU per day). c. When used alone for females with unexplained infertility. d. When there is a failure to respond to ovulation induction, (e.g., doses of gonadotropins up to 150 IU per day and no follicles ≥ 15 mm in diameter). e. An estradiol level <100 pg/ml/follicle ≥15 mm in diameter. f. Doses that exceed 450 IU/day for ART or 150 IU/day for ovulation induction, respectively. g. Duration of therapy that exceeds 14 days per cycle.

2. Controlled Ovarian Stimulation: Gonadotropins are proven and medically necessary for the treatment for females undergoing controlled ovarian stimulation when all of the following criteria are met: a. Treatment in females without ovulatory dysfunction; and

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Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Follicle Stimulating Nov. 1, 2015 b. Used only in conjunction with intrauterine insemination; and Hormone (FSH) c. One of the following: Gonadotropins 1. Treatment in females with diminished ovarian reserve that have not responded to clomiphene or (continued) letrozole; or 2. Initial treatment for women with diminished ovarian reserve. and d. One of the following: 1. For assisted reproductive technologies (ART), dose does not exceed 450 IU/day, for no more than 14 days per cycle; or 2. For controlled ovulation stimulation, dose does not exceed 150 IU/day, for no more than 14 days per cycle.

Gonadotropins are unproven and not medically necessary for controlled ovarian stimulation in the following situations: a. Treatment in females with unexplained infertility, endometriosis, tubal or male factor infertility. b. When there is a failure to respond to ovarian stimulation, (e.g., doses of gonadotropins up to 150 IU per day and no follicles ≥ 15 mm in diameter). c. An estradiol level <100 pg/ml/follicle ≥15 mm in diameter). d. When there are ≥ 4 follicles which are ≥15 mm in diameter from a previously gonadotropin-induced ovulation, despite a dosage adjustment. e. Following ART cycles that fail to result in conception due to poor ovarian response or poor quality oocytes or embryos. f. Doses that exceed 450 IU/day for ART or 150 IU/day for controlled ovulation stimulation, respectively. g. Duration of therapy that exceeds 14 days per cycle.

3. Male Hypogonadotropic Hypogonadism: Gonadotropoins are proven and medically necessary for the treatment for male hypogonadotropic hypogonadism when all of the following criteria are met: a. One of the following: 1. Diagnosis of male primary hypogonadotropic hypogonadism; or 2. Diagnosis of male secondary hypogonadotropic hypogonadism and b. For the induction of spermatogenesis; and c. Infertility is not due to primary testicular failure. Human Menopausal Nov. 1, 2015 Oxford has engaged Optum to perform reviews of requests for pre-certification (Oxford continues to be responsible Gonadotropins for decisions to limit or deny coverage and for appeals). All authorization/pre-certification requests are handled by (hMG) Optum. To pre-certify a procedure related to the treatment of infertility, please call Optum at 877-512-9340.

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Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Human Menopausal Nov. 1, 2015 This policy refers to the following hMG agents: Gonadotropins  Menopur® (menotropins for injection) (hMG)  Repronex® (menotropins for injection) (continued) All hMG agents currently available on the U.S. market are considered to be therapeutically equivalent.

The clinically appropriate dosing for hMG when used in an ART cycle without an FSH product is 450 IU/day or less for

not more than 14 days of treatment. The total dose of gonadotropin (hMG and FSH) should not exceed 450 IU per

day when used in any mixed stimulation protocol. When used as part of a mixed stimulation protocol (hMG + FSH)

or when used alone for ovulation induction or controlled ovarian stimulation the clinically appropriate maximum

dosing for hMG agents is 150 IU/day. Exceeding this daily dose and duration of treatment has not been proven to be

efficacious in terms of pregnancy outcome.

hMG agents will be referred to as “gonadotropins” in the following medical necessity language.

In absence of a product listed and in addition to applicable criteria outlined within the drug policy, prescribing and dosing information from the package insert is the clinical information used to determine benefit coverage.

The following information pertains to medical necessity review:

B. Diagnosis-Specific Requirements

The information below indicates additional requirements for those indications having specific medical necessity

criteria in the list of proven indications.

hMG gonadotropins are proven and medically necessary for:

1. Ovulation Induction

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Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Human Menopausal Nov. 1, 2015 Gonadotropins are proven and medically necessary for the treatment for females with ovulatory Gonadotropins dysfunction when one of the following criteria are met: (hMG) a. Anovulation; or (continued) b. Oligo-ovulation; or c. All of the following: 1. Amenorrhea; and 2. Other specific causative factors (e.g., thyroid disease, hyperprolactinemia) have been excluded or treated; and 3. Failure to ovulate with either Clomid (clomiphene citrate) or Femara (letrozole) and d. One of the following: 1. For assisted reproductive technologies (ART), dose does not exceed 450 IU/day, for no more than 14 days per cycle; or 2. For ovulation induction, dose does not exceed 150 IU/day, for no more than 14 days per cycle.

Gonadotropins are unproven and not medically necessary for females with ovulatory dysfunction in the following situations: a. Beyond the 6th gonadotropin induced ovulatory cycle. b. When there are ≥ 4 follicles which are ≥15 mm in diameter from a previously gonadotropin-induced ovulation, despite a dosage adjustment (e.g., doses of gonadotropin down to 37.5 IU per day). c. When used alone for females with unexplained infertility. d. When there is a failure to respond to ovulation induction, (e.g., doses of gonadotropins up to 150 IU per day and no follicles ≥ 15 mm in diameter) e. An estradiol level <100 pg/ml/follicle ≥15 mm in diameter. f. Doses that exceed 450 IU/day for ART or 150 IU/day for ovulation induction, respectively. g. Duration of therapy that exceeds 14 days per cycle.

2. Controlled Ovarian Stimulation:

Gonadotropins are proven and medically necessary for the treatment for females undergoing controlled ovarian stimulation when all of the following criteria are met: a. Treatment in females without ovulatory dysfunction; and b. Used in conjunction with intrauterine insemination; and c. One of the following: 1. Treatment in females with diminished ovarian reserve that have not responded to clomiphene or letrozole; or 2. Initial treatment for women with diminished ovarian reserve and d. One of the following: 1. For assisted reproductive technologies (ART), total gonadotropin dose does not exceed 450 IU/day, for

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Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Human Menopausal Nov. 1, 2015 no more than 14 days per cycle; or Gonadotropins 2. For controlled ovulation stimulation, dose does not exceed 150 IU/day, for no more than 14 days per (hMG) cycle. (continued) Gonadotropins are unproven and not medically necessary for controlled ovarian stimulation in the following situations: a. Treatment in females with unexplained infertility, endometriosis, tubal or male factor infertility. b. When there is a failure to respond to ovarian stimulation, (e.g., doses of gonadotropins up to 150 IU per day and no follicles ≥ 15 mm in diameter). c. An estradiol level <100 pg/ml/follicle ≥15 mm in diameter). d. When there are ≥ 4 follicles which are ≥15 mm in diameter from a previously gonadotropin-induced ovulation, despite a dosage adjustment. e. Following ART cycles that fail to result in conception due to poor ovarian response or poor quality oocytes or embryos. f. Doses that exceed 450 IU/day for ART or 150 IU/day for controlled ovulation stimulation, respectively. g. Duration of therapy that exceeds 14 days per cycle.

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale 17-Alpha- Nov. 1, 2015  Added benefit considerations 17-alpha-hydroxyprogesterone caproate, commonly called 17P, may also be Hydroxypro- language for Essential Health referred to as 17-OHP, 17-OHPC, 17Pc, Makena™, 17-alpha gesterone Caproate Benefits for Individual and Small hydroxyprogesterone, hydroxyprogesterone, hydroxy-progesterone, and (Makena and 17P) Group plans to indicate: hydroxy progesterone. Hereafter, it will be referred to as 17P. o For plan years beginning on Note: Oral and intravaginal formulations of progesterone are not addressed or after January 1, 2014, the in this policy. Affordable Care Act of 2010 (ACA) requires fully insured Intramuscular injection of 17P is proven and medically necessary for non-grandfathered individual the prevention of spontaneous preterm birth when all of the and small group plans (inside following criteria are met:

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Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale 17-Alpha- Nov. 1, 2015 and outside of Exchanges) to  Current singleton pregnancy; and Hydroxypro- provide coverage for ten  History of a prior spontaneous preterm birth of a singleton pregnancy; gesterone Caproate categories of Essential Health and (Makena and 17P) Benefits (“EHBs”)  Treatment is initiated between 16 weeks, 0 days of gestation and 26 (continued) o Large group plans (both self- weeks, 6 days of gestation; and funded and fully insured), and  Administration is to continue weekly until 36 weeks, 6 days of gestation small group ASO plans, are or delivery, whichever occurs first not subject to the requirement to offer coverage Intramuscular injection of 17P is unproven and not medically for EHBs; however, if such necessary for: plans choose to provide  Prevention of spontaneous preterm birth in women with any of the coverage for benefits which following: are deemed EHBs (such as o Short cervix with or without cerclage and no prior preterm birth; maternity benefits), the ACA o Current multi-fetal pregnancy (twins or greater); requires all dollar limits on o Previous medically indicated preterm birth those benefits to be removed  Initiation of 17P after 26 weeks, 6 days of gestation on all Grandfathered and Non- Although there are ongoing clinical trials to broaden the indications for the Grandfathered plans use of 17P, at this time uses as indicated above are considered unproven and o The determination of which not medically necessary. benefits constitute EHBs is made on a state by state *Additional Information regarding compounded 17P: basis; as such, when using The active ingredient in the compounded 17P and Makena is this guideline, it is important hydroxyprogesterone caproate. Both have castor oil as an inactive ingredient. to refer to the member The compounded version can be made with an alternate oil base in the event specific benefit document to of patient hypersensitivity to castor oil. Makena has the additional inactive determine benefit coverage ingredients of benzyl benzoate and benzyl alcohol (a preservative). Based on  Updated supporting information the active ingredient, compounded preservative-free 17P is considered to reflect the most current clinical clinically interchangeable with Makena. evidence and references Compounding pharmacies must comply with United States Pharmacopeia (USP) Chapter 797, which sets standards for the compounding, 1 transportation, and storage of compounded sterile products (CSP). The Pharmacy Compounding Accreditation Board will verify that the pharmacy is adhering to these standards.2

*Note: The FDA has stated that approved drug products provide a greater assurance of safety and effectiveness than do compounded products. Please refer to the U.S. Food and Drug Administration (FDA) section of this policy for additional information.

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Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Alemtuzumab Oct. 1, 2015  Updated lists of applicable codes; Note: This policy applies only to non-oncology indications. For additional added language to indicate ICD- information regarding oncology indications, please refer to policy: Injectable 10-CM (diagnoses) and ICD-10- Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines. PCS (inpatient procedures) must be used to report services Campath (alemtuzumab) is proven and medically necessary when used in provided on or after 10/01/2015: the treatment of: o ICD-9 codes will not be 1. Members undergoing peripheral blood stem cell (PBSC) and/or bone accepted for services provided marrow transplantation on or after 10/01/2015 2. Members undergoing solid organ transplantation o ICD-10 codes will not be accepted for services provided *Effective September 4th, 2012, Campath will no longer be available prior to 10/01/2015 commercially, but will be provided through the Campath Distribution Program  Updated list of applicable HCPCS free of charge. Additional details about this program may be found at codes to reflect quarterly code http://www.campath.com. edits (effective 10/01/2015); Oxford will not provide coverage of Campath in relapsing-remitting multiple added Q9979 sclerosis (RRMS).

Lemtrada (alemtuzumab) is proven and medically necessary for treatment of relapsing-remitting multiple sclerosis when all of the following criteria are met: A. Diagnosis of relapsing-remitting multiple sclerosis (RRMS); and B. One of the following: 1. Treatment - naïve to alemtuzumab: a. Member has history of failure following a trial for at least 4 weeks or history of intolerance or contraindication to two of the following: 1) interferon β-1a (Avonex® or Rebif®)) 2) interferon β-1b (Betaseron® or Extavia®) 3) glatiramer acetate (Copaxone®) 4) dimethyl fumarate (Tecfidera®) 5) teriflunomide (Aubagio®) 6) fingolimod (Gilenya®) 7) peginterferon beta-1a (Plegridy™) and b. Member has not been previously treated with alemtuzumab; and c. Member is not receiving alemtuzumab in combination with another disease modifying agent (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, or teriflunomide); and

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Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Alemtuzumab Oct. 1, 2015 d. Initial dosing is administered: 12 mg intravenously daily for 5 (continued) consecutive days; and e. Regimen is administered only once within 12 months or 2. Treatment-experienced with alemtuzumab: a. Member has previously received treatment with alemtuzumab; and b. Member is not receiving alemtuzumab in combination with another disease modifying agent (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, or teriflunomide); and c. Retreatment dosing is administered: 12 mg intravenously daily for 3 consecutive days; and d. Regimen is administered only once within 12 months

Coverage of Lemtrada is limited up to two treatment courses (5 day initial and 3 day end course). Requests for additional doses/courses beyond two courses will not be approved.

Oxford will not provide coverage of Lemtrada for indications other than

relapsing-remitting multiple sclerosis RRMS.

Alemtuzumab is unproven and not medically necessary for the treatment of: 1. Rheumatoid arthritis 2. Autoimmune neutropenia 3. Autoimmune hemolytic anemia 4. Pure red cell aplasia 5. Immune thrombocytopenic purpura 6. Evan's syndrome 7. Autoimmune pancytopenia Core Oct. 1, 2015  Updated coverage rationale; Core decompression is proven and medically necessary for the Decompression for clarified language pertaining to treatment of early (pre-collapse stage I and II) avascular necrosis of Avascular Necrosis clinical evidence/study findings the femoral head.  Updated supporting information

to reflect the most current Core decompression is unproven and not medically necessary for the clinical evidence and references treatment of late avascular necrosis of the femoral head or for avascular necrosis elsewhere, including the humeral head, the distal femur, the talus or the mandibular condyle.

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Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Core Oct. 1, 2015 The available evidence for core decompression for these conditions is limited Decompression for and low quality. Most clinical studies involve a small number of patients and Avascular Necrosis lack proper controls. Therefore, there is insufficient data to allow conclusions (continued) regarding the safety and efficacy of core decompression for these indications.

Diagnostic (Basic) Oct. 1, 2015  Updated benefit considerations; 1. Diagnostic (basic) infertility procedures are covered under the General Procedures for added reference link to the benefits package. The benefits are the same as those for testing related Infertility Optum Infertility Clinical to any other disease or condition. This testing may include but is not Guidelines limited to:  Updated lists of applicable codes; o Initial evaluation (history and physical examination) added language to indicate ICD- o Hysterosalpingogram 10-CM (diagnoses) and ICD-10- o Diagnostic Hysteroscopy PCS (inpatient procedures) must o Diagnostic Laparoscopy be used to report services o Sonohysterogram provided on or after 10/01/2015: o Blood work and laboratory evaluation: (e.g. Follicle Stimulating o ICD-9 codes will not be Hormone, Leuteinizing Hormone, Estradiol, Progesterone, Prolactin, accepted for services provided Thyroid Function Tests, Anti-Müllerian Hormone, Glucose, Insulin) on or after 10/01/2015 . Evaluation of androgens (testosterone, dehydroepiandrosterone o ICD-10 codes will not be sulfate, androstenedione, etc.) is indicated in the setting of accepted for services provided hirsutism or suspected adrenal disease. prior to 10/01/2015 . Evaluation of cortisol, ACTH, etc. is indicated in the setting of suspected Cushing’s disease o Sonogram to evaluate pelvic structures and/or to determine an antral follicle count o Post-coital test o Endometrial biopsy o Semen Analysis/Sperm Antibodies – (the male partner must be covered under the policy or have separate infertility coverage) o Testicular Biopsy (when done for diagnostic purposes only).

2. Pre-implantation Genetic Diagnosis (PGD) for the diagnosis of known genetic inheritable disorders only, is covered under the general benefits package. An Infertility benefit is not required for coverage of these services.* o PGD is indicated to avoid the transmission of known genetic disorders to potential offspring o Genetic testing of prospective parents or other family members may be required to establish the proper genetic marker needed for PGD o Sex selection is indicated only to prevent the transmission of sex-

16 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Diagnostic (Basic) Oct. 1, 2015 linked genetic disorders Procedures for o Family balancing is not medically necessary Infertility (continued) *Note: This does not include pre-implantation genetic screening (PGS), which is considered experimental/investigational. Please refer to: o Experimental / Investigational Treatment o Experimental / Investigational Treatment for NJ Plans

The PGD benefit coverage is related only to PGD services, including biopsy and genetic analysis. In-vitro fertilization services are not covered unless otherwise medically indicated and a covered benefit.

Embolization of the Oct. 1, 2015  Updated lists of applicable codes; Embolization of the ovarian or internal iliac veins is considered Ovarian and Iliac added language to indicate ICD- unproven and not medically necessary as a treatment for pelvic Veins for Pelvic 10-CM (diagnoses) and ICD-10- congestion syndrome. Congestion PCS (inpatient procedures) must The body of evidence in the peer-reviewed medical literature regarding Syndrome be used to report services embolization of the ovarian or internal iliac veins for the treatment of pelvic provided on or after 10/01/2015: congestion syndrome is insufficient and poor quality. Additional well- o ICD-9 codes will not be designed randomized controlled trials are necessary to establish the relative accepted for services provided safety and efficacy of the embolization procedure as a treatment of pelvic on or after 10/01/2015 congestion syndrome. o ICD-10 codes will not be accepted for services provided prior to 10/01/2015 Lithotripsy for Oct. 1, 2015  Routine review; no change to Extracorporeal shock wave lithotripsy (ESWL) is unproven and not Salivary Stones coverage rationale or lists of medically necessary for the treatment of salivary stones. applicable codes There is insufficient evidence to support the use of ESWL for managing salivary stones. Further research with randomized controlled studies is required to demonstrate the effectiveness of ESWL.

Endoscopic intracorporeal laser lithotripsy is unproven and not medically necessary for the treatment of salivary stones. The evidence regarding intracorporeal laser lithotripsy is limited and includes studies involving a small number of patients. Further research with randomized controlled studies and larger patient sample sizes is required to demonstrate the effectiveness of endoscopic intracorporeal laser lithotripsy.

17 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Mifeprex Oct. 1, 2015  Updated coverage rationale; Mifeprex (mifepristone) is proven and medically necessary for (Mifepristone, RU- replaced references to generic termination of pregnancy through 63 days gestation when 486) drug name “mifepristone” with administered under the supervision of a qualified physician. For brand name “Mifeprex” purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 day cycle with ovulation occurring at mid- cycle.

Mifeprex should be prescribed only by physicians who have read and

understood the prescribing information. Mifeprex may be administered only

in a clinic, medical office, or hospital, by or under the supervision of a

physician, able to assess the gestational age of an embryo and to diagnose

ectopic pregnancies. Physicians must also be able to provide surgical

intervention in cases of incomplete abortion or severe bleeding, or have

made plans to provide such care through others, and be able to assure

patient access to medical facilities equipped to provide blood transfusions and

resuscitation, if necessary.

Mifeprex is unproven and not medically necessary for treatment of:

1. Leiomyomata

2. Endometriosis

3. Breast cancer

4. Ovarian cancer

5. Meningioma

6. Psychotic major depression

7. Oral contraception

8. Induction of labor

Recommended Guidelines

Therapeutic Abortions Coverage of therapeutic abortions is subject to benefit availability and any specific limitations/maximums as outlined in the Member's certificate of coverage/health benefits plan.

Oxford covers therapeutic abortions that may include the following indications:

 Medical conditions which cause pregnancy to pose substantial risk to maternal health such as cardiac or cardiovascular anomalies, cardiovascular disease, renal disease, malignancy, and severe diabetes

18 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Mifeprex Oct. 1, 2015 mellitus (Mifepristone, RU-  The certain diagnosis of: 486) o Chromosomal abnormalities inconsistent with normal life in the fetus (continued) o Major structural defects such as severe neural tube defects, severe cardiac abnormalities, severe ventral wall defects, or other severe structural defects o Major metabolic abnormalities such as sickle cell disease, Tay Sachs disease, cystic fibrosis, or major biochemical abnormalities  Pregnancy which is the result of rape or incest  Exposure to known teratogenic agents, which pose significant risk of fetal developmental abnormalities

Elective Abortions

Coverage of elective abortions is subject to benefit availability and any

specific limitations/maximums as outlined in the Member's certificate of

coverage/health benefits plan.

Note:  Treatment of complications of elective and therapeutic abortions is considered medically necessary and therefore not subject to annual and dollar limits.  If an abortion CPT code is billed, it is reimbursed according to the elective abortion benefit, unless the diagnosis code is listed as a "Therapeutic ICD- 9 Diagnosis Code" in Payment Guidelines below.

Nerve Graft to Oct. 1, 2015  Routine review; no change to Sural or other nerve grafts to restore erectile function during radical Restore Erectile coverage rationale or lists of prostatectomy are considered unproven and not medically necessary.

Function During applicable codes No comparative studies between nerve grafts and standard medical therapy Radical (e.g., intracorporal injection, or vacuum erection devices have been Prostatectomy completed. The evidence for nerve grafts for restoration of erectile function is derived mainly from non-randomized studies limited by small sample sizes. A randomized controlled trial was discontinued when it was determined that unilateral nerve-sparing radical prostatectomy was not effective. Presacral Oct. 1, 2015  Added reference link to policy Presacral neurectomy is proven and medically necessary for treating Neurectomy and titled Abnormal Uterine Bleeding women with primarily midline pelvic pain unresponsive to medical Uterine Nerve and Uterine Fibroids; no change therapy, which includes the following: Ablation for Pelvic to coverage rationale or list of  A 3-month trial of oral contraceptives; or Pain applicable codes  If oral contraceptives are contraindicated, menstrual suppression with progesterone or gonadotropin-releasing hormone (GnRH) agonist therapy.

19 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale

Presacral Oct. 1, 2015 Presacral neurectomy is unproven and not medically necessary for Neurectomy and treating lateral pelvic pain or symptoms other than midline pelvic Uterine Nerve pain. There is a lack of evidence that presacral neurectomy provides Ablation for Pelvic a clinical benefit in these patient populations. Pain (continued) Uterine nerve ablation (UNA) and laparoscopic uterine nerve ablation (LUNA) are unproven and not medically necessary for treating chronic pelvic pain associated with dysmenorrhea or endometriosis.

There is insufficient evidence in the published clinical literature establishing the effectiveness of UNA and LUNA for the treatment of dysmenorrhea. The durability of pain relief from UNA and LUNA will determine the potential beneficial effect on health outcomes. This will require well-designed clinical studies with long-term results. Repository Nov. 1, 2015  Updated and reorganized This policy addresses H.P. Acthar Gel when administered by a medical Corticotropin coverage rationale: professional and covered under the medical benefit. For coverage guidelines Injection (H.P. o Added language to indicate for self-administration of H.P. Acthar Gel, refer to the policy titled Drug Acthar Gel) the medically necessary Coverage Guidelines. services are “proven” o Replaced references to H.P. Acthar Gel (repository corticotropin injection is proven and “repository corticotropin medically necessary for the treatment of: injection” with “H.P. Acthar 1. Infantile spasm (i.e., West Syndrome) for up to 4 weeks when all Gel” of the following criteria are met A. Diagnosis of infantile spasms (i.e., West Syndrome); and B. Patient is less than 2 years old; and C. H.P Acthar Gel dosing for infantile spasm is as follows: a. Initial dose: 75 U/m2 intramuscular (IM) twice daily for 2 weeks. b. After 2 weeks, dose should be tapered according to the following schedule: 30 U/m2 IM in the morning for 3 days; 15 U/m2 IM in the morning for 3 days; 10 U/m2 IM in the morning for 3 days; and 10 U/m2 IM every other morning for 6 days (3 doses). 2. Opsoclonus-myoclonus syndrome (i.e., OMS, Kinsbourne Syndrome)

H.P Acthar Gel is not medically necessary for treatment of acute exacerbations of multiple sclerosis. Published clinical evidence does not demonstrate superiority of Acthar to other available corticosteroids.

20 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Repository Nov. 1, 2015 The H.P. Acthar package insert has listed other conditions in which it may be Corticotropin used. Since H.P. Acthar is more costly than an alternative drug that is at Injection (H.P. least as likely to produce equivalent therapeutic results, UHCP has Acthar Gel) determined that use of H.P. Acthar Gel is unproven and not medically (continued) necessary for treatment of the following disorders and diseases: A. Rheumatic Disorders: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis, ankylosing spondylitis B. Collagen Diseases: systemic lupus erythematosus, systemic dermatomyositis (polymyositis) C. Dermatologic Diseases: Severe erythema multiforme, Stevens-Johnson syndrome D. Allergic States: Serum sickness E. Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation. F. Respiratory Diseases: Symptomatic sarcoidosis G. Edematous State: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus. H. Any indication outside of the medically necessary indications above. Rituxan Nov. 1, 2015  Updated coverage rationale: Please refer to the policy titled Injectable Chemotherapy Drugs: Application (Rituximab) o Replaced references to of NCCN Clinical Practice Guidelines for updated information based upon the generic drug name National Comprehensive Cancer Network (NCCN) Drugs & Biologics “omalizuamab” with brand Compendium (NCCN Compendium) for oncology indications. name “Rituxan” o Added language to indicate Rituxan (rituximab) is proven and medically necessary for the the proven indications are treatment of: “medically necessary” 1. Idiopathic or immune thrombocytopenic purpura (ITP);  Updated benefit considerations; Additional information to support medical necessity review: added language to indicate: Rituximab is medically necessary for the treatment of immune o Some certificates of thrombocytopenic purpura when all of the following criteria are coverage allow coverage of met: experimental/investigational/ A. Diagnosis of idiopathic or immune thrombocytopenic purpura (ITP); unproven treatments for life- and threatening illnesses when B. Documented platelet count < 50 x 109 / L; and certain conditions are met C. History of failure, contraindication, or intolerance to one of the o The member-specific benefit following:

21 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Rituxan Nov. 1, 2015 document must be consulted 1) Corticosteroids (Rituximab) to make coverage decisions 2) Immune globulin (continued) for this service 3) Splenectomy o Some states mandate 2. Autoimmune mucocutaneous blistering diseases; benefit coverage for off-label 3. Rituxan is proven and medically necessary for the treatment of use of medications for some Wegener's granulomatosis and microscopic polyangiitis (both diagnoses or under some ANCA-associated vasculidities); when both of the following circumstances criteria are met: o Where such mandates apply, A. Diagnosis of Wegener’s granulomatosis or microscopic polyangiitis; they supersede language in and the benefit document or in B. One of the following: the medical or drug policy 1) Patient is receiving concurrent therapy with glucocorticoids  Updated supporting information 2) History of contraindication or intolerance to glucocorticoids to reflect the most current 4. Autoimmune hemolytic anemia, including chronic cold agglutinin clinical evidence and references disease 5. Rituxan is proven and medically necessary for the treatment of rheumatoid arthritis when all of the following criteria are met: A. Moderate to severe disease activity [e.g., swollen, tender joints with limited range of motion]; and B. One of the following: 1) Patient is receiving concurrent therapy with methotrexate 2) History of, contraindication or intolerance to methotrexate and C. History of failure, contraindication or intolerance to at least one tumor necrosis factor (TNF) inhibitors [e.g., adalimumab (Humira), etanercept (Enbrel), infliximab (Remicade)], and D. Patient is not receiving rituximab in combination with either of the following: 1) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)] 2) Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] 6. Post-transplant B-lymphoproliferative disorder 7. Neuromyelitis optica

Rituxan as unproven and not medically necessary for the indications listed below: 1. Anti-GM1 antibody-related neuropathies; 2. Kaposi sarcoma-associated herpes virus-related multicentric Castleman disease;

22 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Rituxan Nov. 1, 2015 3. Pure red cell aplasia; (Rituximab) 4. Systemic lupus erythematosus; (continued) 5. Acquired factor VIII inhibitors; 6. Polyneuropathy associated with anti-MAG antibodies; 7. Idiopathic membranous nephropathy; 8. Chronic graft-versus-host disease; 9. Reduction of anti-HLA antibodies in patients awaiting renal transplant; and 10. Multiple sclerosis 11. Dermatomyositis and polymyositis

While a beneficial effect of rituximab has been reported in some of these conditions, none of them have shown positive results in large, controlled clinical trials. Routine Foot Care Oct. 1, 2015  Updated lists of applicable codes; Oxford will reimburse for routine foot care procedures for Members with added language to indicate ICD- diabetes or who are at risk for neurological or vascular disease arising from 10-CM (diagnoses) and ICD-10- diseases such as diabetes. Refer to the Applicable Codes section of the policy PCS (inpatient procedures) must for additional information. be used to report services provided on or after 10/01/2015: o ICD-9 codes will not be accepted for services provided on or after 10/01/2015 o ICD-10 codes will not be accepted for services provided prior to 10/01/2015  Updated list of applicable HCPCS codes to reflect quarterly code edits (effective 10/01/2015): revised description for L3170 Sandostatin Lar Nov. 1, 2015  Updated coverage rationale; Please refer to Injectable Chemotherapy Drugs: Application of NCCN Clinical Depot (Octreotide added language to indicate if Practice Guidelines for updated information based on the National Acetate) service is “proven” or “unproven” Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium for to applicable medically oncology indications. necessary/not medically necessary statement Note: For information regarding coverage for Sandostatin® subcutaneous  Updated benefit considerations; formulation, refer to: Drug Coverage Guidelines.

23 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Sandostatin Lar Nov. 1, 2015 added language pertaining to 1. Octreotide acetate LAR is proven and medically necessary in the Depot (Octreotide experimental/investigational treatment of Acromegaly when all of the following criteria are Acetate) treatment to indicate: met: (continued) o Some Certificates of Coverage A. Diagnosis of acromegaly by one of the following: allow for coverage of 1) Serum GH level > 1 ng/mL after a 2 hour oral glucose tolerance experimental/investigational/u test (OGTT) at time of diagnosis; or nproven treatments for life- 2) Elevated serum IGF-1 levels (above the age and gender adjusted threatening illnesses when normal range as provided by the physician’s lab) at time of certain conditions are met diagnosis; o The member specific benefit and document must be consulted B. One of the following: to make coverage decisions for 1) Inadequate response to one of the following: this service a) Surgery o Some states mandate benefit b) Radiotherapy coverage for off-label use of c) *Dopamine agonist (e.g., bromocriptine, cabergoline) therapy medications for some or diagnoses or under some 2) Not a candidate for any of the following: circumstances when certain a) Surgery conditions are met b) Radiotherapy o Consult regulations for your c) Dopamine agonist (e.g., bromocriptine, cabergoline) therapy individual state to determine and whether and under what C. Initial treatment with octreotide immediate release (IR) has been circumstances such coverage is shown to be effective and tolerated mandated for a particular state 2. Octreotide acetate LAR is proven and medically necessary in the o Benefit coverage for otherwise treatment of Bleeding gastroesophageal varices associated with unproven service for the liver disease treatment of serious rare Additional information to support medical necessity review: diseases may occur when Octreotide acetate is medically necessary for the treatment of bleeding certain conditions are met; esophageal varices when both of the following criteria are met: refer to Acquired Rare Disease A. Diagnosis of bleeding esophageal varices associated with liver Drug Therapy Exception disease; and

B. Octreotide acetate will be used as an adjunct to endoscopic therapy

3. Octreotide acetate LAR is proven and medically necessary in the

treatment of Chemotherapy and/or radiation-induced diarrhea

4. Octreotide acetate LAR is proven and medically necessary in the

treatment of Refractory HIV/AIDS-related diarrhea

Additional information to support medical necessity review: Octreotide acetate is medically necessary for the treatment of refractory

24 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Sandostatin Lar Nov. 1, 2015 HIV/AIDS-related diarrhea when both of the following criteria are met: Depot (Octreotide A. Diagnosis of HIV/AIDS-related diarrhea; and Acetate) B. History of failure, contraindication, or intolerance to standard therapy (continued) (e.g., loperamide, diphenoxylate/atropine) 5. Octreotide acetate LAR is proven and medically necessary in the treatment of Malignant bowel obstruction

Octreotide acetate is unproven and not medically necessary for treating the following conditions: 1. chylothorax 2. dumping syndrome 3. pancreatitis 4. prevention of postoperative complications following pancreatic surgery 5. short bowel syndrome 6. persistent hyperinsulinemic hypoglycemia of infancy

Octreotide acetate is unproven and not medically necessary for treating other conditions not listed above as medically necessary due to the lack of published clinical evidence of safety and/or efficacy in published.

Supply limitations may also apply.

Documentation Required for Medical Director Review:  Letter of medical necessity and/or office notes. Total Artificial Oct. 1, 2015  Updated coverage rationale; The SynCardia® temporary Total Artificial Heart (formerly known as Heart added instruction to refer to the the CardioWest™ temporary Total Artificial Heart) is proven and U.S Food and Drug medically necessary as a bridge to heart transplantation in patients Administration (FDA) section for who meet all of the following criteria: humanitarian device exemptions  At risk of imminent death from biventricular failure pending FDA approval;  Have no other medical or surgical treatment options depending on the enrollee-  Eligible for heart transplantation specific benefit document,  Have sufficient space in the chest cavity to accommodate the device. coverage may be available Generally this includes patients who have a body surface area ≥ 1.7m through participation in an eligible clinical trial Note:  Updated supporting information  At this time, only the 70cc SynCardia device has been approved by the to reflect the most current FDA U.S. Food and Drug Administration (FDA). information and references  The Freedom® portable driver system is FDA approved for use with the

25 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Total Artificial Oct. 1, 2015 SynCardia device in clinically stable patients. See the FDA section of this Heart policy for additional information. (continued)  Also see the FDA section of this policy for additional information on humanitarian device exemptions pending FDA approval. Depending on the enrollee-specific benefit document, coverage may be available through participation in an eligible clinical trial.

The AbioCor® implantable replacement heart is unproven and not medically necessary as an alternative to heart transplantation. There is limited evidence that the AbioCor replacement heart, as a permanent replacement for the failing heart, improves survival. Well- designed studies are needed to establish the safety and efficacy of this device. Transcutaneous Oct. 1, 2015  Routine review; no content Transcutaneous electrical nerve stimulation (TENS) including Electrical Nerve changes electrical acupoint stimulation devices is unproven and not medically Stimulation (TENS) necessary for the treatment of nausea and vomiting of any etiology. for the Treatment There is insufficient evidence to conclude that TENS decreases post-operative of Nausea and nausea and vomiting (PONV), chemotherapy-induced nausea, and the nausea Vomiting and vomiting of pregnancy and motion sickness. Clinical evidence regarding the efficacy of TENS for treating nausea and vomiting is conflicting and further research is warranted. Treatment of Oct. 1, 2015  Updated benefit considerations; Oxford has engaged Optum to perform reviews of requests for the treatment Infertility added language to indicate the of infertility. Optum has established an infrastructure to support the review, Optum Infertility Clinical development, and implementation of comprehensive clinical guidelines. The Guidelines may be found on guidelines are available on the Optum web site: Optum’s website corresponding https://www.myOptumcomplexmedical.com/gateway/public/infertility/produc reference link provided) tsAndServices.jsp

Covered services are subject to medical necessity review* and will be

determined based upon review of the members benefit, Oxford Policies and

Optum's Infertility Clinical Guidelines. We reserve the right to provide

coverage for a requested service in the manner we determine to be medically

appropriate/medically effective and the most cost effective.

Covered services must be performed at facilities that conform to the standards of the American Society of Reproductive Medicine or the American College of Obstetricians and Gynecologists.

Comprehensive and Advanced Level Techniques must be performed only by or under the supervision of a Board Certified or eligible Reproductive

26 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015 Endocrinologists. Infertility *For additional information regarding medical necessity review, refer to (continued) Oxford’s Clinical Review policy.

Procedures to Treat Infertility (subject to medical necessity review)

Infertility treatments include comprehensive level techniques, also

referred to as mid-level (from ovarian stimulation up to and including

artificial insemination) and advanced level techniques [Assisted

Reproductive Technologies (ART)].

Comprehensive Level Techniques (also referred to as mid-level)

 Ovulation induction with oral or injectable medications;

 Controlled ovarian stimulation with oral medications;

 Cervical or Intrauterine artificial insemination;

 Sperm washing;

 Sperm isolation; simple prep (e.g. sperm wash and swim up);

 Sperm isolation; complex prep (e.g. Percoll gradient, albumin gradient);

 Electroejaculation.

Advanced Level Techniques

 In vitro fertilization (IVF);

 Gamete intrafallopian transfer (GIFT);

 Ultrasonic guidance for aspiration of ova, imaging and supervision;

 Oocyte identification from follicular fluid;

 Fertilization of oocyte(s);

 Intracytoplasmic sperm injection (ICSI);

 Microscopic epididymal sperm aspiration (MESA);

 Testicular sperm aspiration (TESA);

 Percutaneous epididymal sperm aspiration (PESA);

 Sperm identification from aspiration (other than seminal fluid);

 Culture of /embryo(s);

 Assisted embryo hatching, microtechniques;

 Thawing of cryopreserved oocyte(s)/embryo(s);

 Preparation of embryo for transfer (any method);

 Embryo transfer;

o Previously frozen embryo(s) must be transferred prior to another

fresh egg retrieval

 Fertility preservation prior to gonadotoxic treatment including sperm,

27 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015 mature egg (women under the age of 42) or embryo cryopreservation Infertility with storage up to one year; (continued)  Egg donation: fertilization of the oocyte through embryo transfer when otherwise not covered but medically necessary;  IVF for a female without a male partner: IVF would be covered in a female without a male partner only if IVF is otherwise medically indicated and the resulting embryos are transferred only to the originator of the eggs.

Non-Covered Services

Treatments not covered by Oxford are as follows:  Non-medical costs for an ovum donor or sperm donor;  Sperm, embryo(s), reproductive tissue, testicular/ovarian, oocyte storage costs;  Cryopreservation of embryos, oocytes (eggs), sperm or other reproductive tissue;

 Ovulation predictor kits;  Reversal of permanent sterilization procedures;  Cloning;  Any infertility services if the Member has undergone a voluntary sterilization procedure (tubal ligation, fulguration, vasectomy, EssureÂ® insertion): o Coverage may be provided, if a member has undergone a sterilization

reversal with subsequent documented patency of the fallopian tubes or presence of viable sperm in an ejaculate and additionally meets the definition of infertility’ o If the partner (who is a covered member) of the member who has been sterilized meets the definition of infertility, that partner may be eligible for coverage for their specific infertility condition only’

Example: Male has had a vasectomy that has not been reversed. His

female covered partner is anovulatory. Coverage may be provided for

ovulation induction only.

 All costs associated with gestational carriers and surrogacy;*

*Note: Maternity services are covered for Oxford Members acting as surrogates.

 Experimental procedures and treatments; refer to policy titled Experimental/Investigational Treatment.

28 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015  Updated benefit considerations; Oxford has engaged Optum to perform reviews of requests for the treatment of Infertility for added language to indicate the infertility. Optum has established an infrastructure to support the review, Connecticut Groups Optum Infertility Clinical development, and implementation of comprehensive clinical guidelines. The Guidelines may be found on guidelines are available on the Optum web site: Optum’s website (corresponding https://www.myoptumhealthcomplexmedical.com/gateway/public/infertility/pro reference link provided) ductsAndServices.jsp

Covered services are subject to medical necessity review* and will be determined based upon review of the members benefit, Oxford Policies and Optum's Infertility Clinical Guidelines. We reserve the right to provide coverage for a requested service in the manner we determine to be medically appropriate/medically effective and the most cost effective.

Covered services must be performed at facilities that conform to the standards of the American Society of Reproductive Medicine or the Society for Reproductive Endocrinology and Infertility.

Comprehensive and Advanced Level Techniques must be performed only by or under the supervision of a Board Certified or Board Eligible Reproductive Endocrinologists.

*For additional information regarding medical necessity review, refer to Oxford’s Clinical Review policy.

Procedures to Treat Infertility (subject to medical necessity review) Infertility treatments include comprehensive level techniques, also referred to as mid-level (from ovarian stimulation up to and including artificial insemination) and advanced level techniques [Assisted Reproductive Technologies (ART)].

Comprehensive Level Techniques (also referred to as mid-level)  Ovulation induction with oral or injectable medications;  Controlled ovarian stimulation with oral medications;  Cervical or Intrauterine artificial insemination;  Sperm washing;  Sperm isolation; simple prep (e.g. sperm wash and swim up);  Sperm isolation; complex prep (e.g. Percoll gradient, albumin gradient);  Electroejaculation.

Advanced Level Techniques  In vitro fertilization (IVF);

29 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015  Gamete intrafallopian transfer (GIFT); Infertility for  Ultrasonic guidance for aspiration of ova, imaging and supervision; Connecticut Groups  Oocyte identification from follicular fluid; (continued)  Fertilization of oocyte(s);  Intracytoplasmic sperm injection (ICSI);  Microscopic epididymal sperm aspiration (MESA);  Testicular sperm aspiration (TESA);  Percutaneous epididymal sperm aspiration (PESA);  Sperm identification from aspiration (other than seminal fluid);  Culture of /embryo(s);  Assisted embryo hatching, microtechniques;  Thawing of cryopreserved oocyte(s)/embryo(s);  Preparation of embryo for transfer (any method);  Embryo transfer; o Previously frozen embryo(s) must be transferred prior to another fresh egg retrieval  Fertility Preservation prior to gonadotoxic treatment including sperm, mature egg (women under the age of 42) or embryo cryopreservation with storage up to one year;  Egg Donation: fertilization of the oocyte through embryo transfer when otherwise not covered but medically necessary;  IVF for a female without a male partner: IVF would be covered in a female without a male partner only if IVF is otherwise medically indicated and the resulting embryos are transferred only to the originator of the eggs.

Non-Covered Services

Treatments/services not covered by Oxford are as follows:  Cost of donor sperm or an ovum donor when oocyte retrieved from someone other than recipient;  Sperm, embryo(s), reproductive tissue, testicular/ovarian, oocyte storage costs;  Cryopreservation and/or storage of embryos, oocytes (eggs), sperm or

other reproductive tissue;  Ovulation predictor kits;  Reversal of permanent sterilization procedures;  Cloning;  Any infertility treatment if Member has undergone voluntary sterilization

30 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015 procedure (tubal ligation, fulguration, vasectomy, Essure® insertion): Infertility for o Coverage may be provided, if a member has undergone a sterilization Connecticut Groups reversal with subsequent documented patency of the fallopian tubes (continued) or presence of viable sperm in an ejaculate and additionally meets the definition of infertility. o If the partner (who is a covered member) of the member who has been sterilized meets the definition of infertility, that partner may be eligible for coverage for their specific infertility condition only. Example: Male has had a vasectomy that has not been reversed. His female covered partner is anovulatory. Coverage may be provided for ovulation induction only.  All costs associated with gestational carriers and surrogacy* *Note: Maternity services are covered for Oxford Members acting as surrogates.  Experimental procedures and treatments; refer to Experimental/Investigational Treatment Treatment of Oct. 1, 2015  Updated benefit considerations; Oxford has engaged Optum to perform reviews of requests for the treatment of Infertility for New added language to indicate the infertility. Optum has established an infrastructure to support the review, Jersey Large Optum Infertility Clinical development, and implementation of comprehensive clinical guidelines. The Groups Guidelines may be found on guidelines are available on the Optum web site: Optum’s website (corresponding https://www.myoptumhealthcomplexmedical.com/gateway/public/infertility/pr reference link provided) oductsAndServices.jsp

Covered services are subject to medical necessity review* and will be

determined based upon review of the members benefit, Oxford Policies and

Optum's Infertility Clinical Guidelines. We reserve the right to provide

coverage for a requested service in the manner we determine to be medically

appropriate/medically effective and the most cost effective.

Covered services must be performed at facilities that conform to the standards of the American Society of Reproductive Medicine or the American College of Obstetricians and Gynecologists.

Comprehensive and Advanced Level Techniques must be performed only by or under the supervision of a Board Certified or eligible Reproductive Endocrinologists.

*For additional information regarding medical necessity review, refer to Oxford’s Clinical Review policy.

31 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015 Procedures to Treat Infertility (subject to medical necessity review)

Infertility for New Infertility treatments include comprehensive level techniques, also Jersey Large referred to as mid-level (from ovarian stimulation up to and including Groups artificial insemination) and advanced level techniques [Assisted (continued) Reproductive Technologies (ART)].

The following mid-level and advanced techniques are covered under the NJ Large group base medical benefit.

Comprehensive Level Techniques (also referred to as mid-level) (no limit to the number of cycles)  Ovulation induction with oral or injectable medications;  Controlled ovarian stimulation with oral medications;  Cervical or Intrauterine artificial insemination;  Sperm washing;  Sperm isolation; simple prep (e.g. sperm wash and swim up);  Sperm isolation; complex prep (e.g. Percoll gradient, albumin gradient);  Electroejaculation.

Advanced Level Techniques  In vitro fertilization (IVF); Note: This includes in vitro fertilization using donor eggs and in vitro fertilization where the embryo is transferred to a gestational carrier or surrogate.  Gamete intrafallopian transfer (GIFT);  Ultrasonic guidance for aspiration of ova, imaging and supervision;  Oocyte identification from follicular fluid;  Fertilization of oocyte(s);  Intracytoplasmic sperm injection (ICSI);  Microscopic epididymal sperm aspiration (MESA);  Testicular sperm aspiration (TESA);  Percutaneous epididymal sperm aspiration (PESA);  Sperm identification from aspiration (other than seminal fluid);  Culture of /embryo(s);  Assisted embryo hatching, microtechniques;  Thawing of cryopreserved oocyte(s)/embryo(s);  Preparation of embryo for transfer (any method); Embryo transfer; o Previously frozen embryo(s) must be transferred prior to another

32 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015 fresh egg retrieval; Infertility for New  Fertility Preservation prior to gonadotoxic treatment including sperm, Jersey Large mature egg (women under the age of 42) or embryo cryopreservation Groups with storage up to one year; (continued)  IVF for a female without a male partner: IVF would be covered in a female without a male partner only if IVF is otherwise medically indicated and the resulting embryos are transferred only to the originator of the eggs;  Medical costs of egg donations including office visits, medication, laboratory and radiology procedures and egg retrieval;  Medical costs of sperm donation;  Medical expenses for gestational carriers, including office visits, medications, laboratory and radiology procedures (including complications) until the completion of the IVF cycle. Note: Pregnancy expenses of gestational carriers are covered only if the gestational carrier is an Oxford insured Member.

Non Covered Services

Treatments not covered by Oxford are as follows:  Non-medical costs for an ovum donor or sperm donor; o Sperm, embryo(s), reproductive tissue, testicular/ovarian, oocyte storage costs;  Cryopreservation of oocytes (eggs), embryos or sperm unless Member is in active treatment;  Ovulation predictor kits;  Reversal of permanent sterilization procedures;  Cloning;  Any infertility services if the Member has undergone a voluntary sterilization procedure (tubal ligation, fulguration, vasectomy, Essure® insertion); o Coverage may be provided, if a member has undergone a sterilization reversal with subsequent documented patency of the fallopian tubes or presence of viable sperm in an ejaculate and additionally meets the definition of infertility. o If the partner (who is a covered member) of the member who has been sterilized meets the definition of infertility, that partner may be eligible for coverage for their specific infertility condition only. . Example: Male has had a vasectomy that has not been reversed.

33 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015 His female covered partner is anovulatory. Coverage may be Infertility for New provided for ovulation induction only. Jersey Large  Experimental procedures and treatments. Refer to the policy titled Groups Experimental/ Investigational Treatment. (continued)

Treatment of Oct. 1, 2015  Updated benefit considerations; Oxford has engaged Optum to perform reviews of requests for the treatment Infertility for New added language to indicate the of infertility. Optum has established an infrastructure to support the review, York Large and Optum Infertility Clinical development, and implementation of comprehensive clinical guidelines. The Small Groups Guidelines may be found on guidelines are available on the Optum web site: Optum’s website (corresponding https://www.myOptumcomplexmedical.com/gateway/public/infertility/produc reference link provided) tsAndServices.jsp

Covered services are subject to medical necessity review* and will be

determined based upon review of the members benefit, Oxford Policies and

Optum's Infertility Clinical Guidelines. We reserve the right to provide

coverage for a requested service in the manner we determine to be medically

appropriate/medically effective and the most cost effective.

Covered services must be performed at facilities that conform to the standards of the American Society of Reproductive Medicine or the American College of Obstetricians and Gynecologists.

Comprehensive and Advanced Level Techniques must be performed only by or under the supervision of a Board Certified or eligible Reproductive Endocrinologists.

*For additional information regarding medical necessity review, refer to Oxford’s Clinical Review Policy.

Comprehensive Level Techniques (also referred to as mid-level)  Ovulation Induction with oral or injectable medications;  Controlled ovarian stimulation with oral medications;  Cervical or Intrauterine artificial insemination;  Sperm washing;

34 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015  Sperm isolation; simple prep (e.g. sperm wash and swim up); Infertility for New  Sperm isolation; complex prep (e.g. Percoll gradient, albumin gradient); York Large and  Electroejaculation. Small Groups Advanced Level Techniques (continued)  In vitro fertilization (IVF);

 Gamete intrafallopian transfer (GIFT);

 Ultrasonic guidance for aspiration of ova, imaging and supervision;

 Oocyte identification from follicular fluid;

 Fertilization of oocyte(s);

 Intracytoplasmic sperm injection (ICSI);

 Microscopic epididymal sperm aspiration (MESA);

 Testicular sperm aspiration (TESA);

 Percutaneous epididymal sperm aspiration (PESA);

 Sperm identification from aspiration (other than seminal fluid);

 Culture of embryo(s);

 Assisted embryo hatching, microtechniques;

 Thawing of cryopreserved oocyte(s)/embryo(s);

 Preparation of embryo for transfer (any method);

 Embryo transfer;

o Previously frozen embryo(s) must be transferred prior to another

fresh egg retrieval

 Fertility Preservation prior to gonadotoxic treatment including sperm,

mature egg (women under the age of 42) or embryo cryopreservation

with storage up to one year;

 Egg Donation: fertilization of the oocyte through embryo transfer when

otherwise not covered but medically necessary;

 IVF for a female without a male partner: IVF would be covered in a

female without a male partner only if IVF is otherwise medically indicated

and the resulting embryos are transferred only to the originator of the

eggs.

Non Covered Services

35 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Treatment of Oct. 1, 2015  Ovulation predictor kits; Infertility for New  Reversal of permanent sterilization procedures; York Large and  Cloning; Small Groups  Any infertility services if the Member has undergone a voluntary (continued) sterilization procedure (tubal ligation, fulguration, vasectomy, Essure® insertion); o Coverage may be provided, if a member has undergone a sterilization reversal with subsequent documented patency of the fallopian tubes or presence of viable sperm in an ejaculate and additionally meets the definition of infertility. o If the partner (who is a covered member) of the member who has been sterilized meets the definition of infertility, that partner may be eligible for coverage for their specific infertility condition only. . Example: Male has had a vasectomy that has not been reversed. His female covered partner is anovulatory. Coverage may be provided for ovulation induction only. All costs associated with gestational carriers and surrogacy* *Note: Maternity services are covered for Oxford Members acting as surrogates.  Experimental procedures and treatments; refer to the policy titled Experimental/ Investigational Treatment.

Unicondylar Spacer Oct. 1, 2015  Removed “Additional Products” Unicondylar spacer devices are unproven and not medically Devices for information listing specific necessary for the treatment of knee joint pain or disability from any Treatment of Pain prosthetic device name cause. or Disability (PreservationTM Unicondylar The evidence is lacking to demonstrate that unicondylar spacers are clinically Knee Prosthesis) effective, and long-term data are not available to establish the safety and  Updated supporting information efficacy of these devices. Published evidence consists of small studies with to reflect the most current mixed results. It is not evident that this treatment postpones or obviates the description of services, clinical need for total joint replacement. evidence, FDA information and references

36 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Vaccines Oct. 1, 2015  Updated list of applicable CPT Oxford provides coverage for immunizations/vaccinations except where codes to reflect quarterly code specifically excluded. Examples of the most common coverage exclusions edits (effective 10/01/2015); include immunizations that are required for travel, employment, education, revised description for 90644, insurance, marriage, adoption, military service, or other administrative 90647, 90648, 90649, 90650, reasons. Refer to the Member's specific certificate of coverage, evidence of 90673, 90698, 90739, 90740 and coverage, summary of benefits and/or health benefits plan documentation for 90748 additional information.

Immunizations that are not classified as a "coverage exclusion" by the Member's plan are considered covered after all of the following conditions are satisfied:

1. US Food and Drug Administration (FDA) approval; and 2. Advisory Committee on Immunization Practices (ACIP) definitive ("shall") recommendation rather a permissive ("may") recommendation published in the Morbidity & Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC). Xolair Nov. 1, 2015  Updated coverage rationale; Xolair (omalizumab) for subcutaneous use is proven and medically (Omalizumab) replaced references to generic necessary for: drug name “omalizuamab” with 1. Adults and adolescents with moderate to severe persistent brand name “Xolair” asthma who meet all of the following criteria  Updated benefit considerations; A. Age 12 years or older added language to indicate: B. Have a positive skin test or in vitro reactivity to a perennial o Some certificates of coverage aeroallergen allow coverage of C. Symptoms inadequately controlled with inhaled corticosteroids experimental/investigational/ D. Have a baseline plasma immunoglobulin E (IgE) level between 30 unproven treatments for life- and 1500 IU/mL threatening illnesses when *Additional information to support medical necessity review: certain conditions are met Xolair is medically necessary for the treatment of adults and o The member-specific benefit adolescents with moderate to severe persistent asthma when all document must be consulted of the following criteria are met: to make coverage decisions A. Age 12 years or older; and for this service B. Diagnosis of moderate to severe persistent uncontrolled asthma as o Some states mandate benefit defined by one of the following: coverage for off-label use of 1. Daily asthmatic symptoms medications for some 2. Daily use of inhaled short-acting beta2-agonist diagnoses or under some 3. Exacerbations affect/limit activity circumstances 4. Exacerbations (requiring oral systemic corticosteroids) ≥ 2 times o Where such mandates apply, a year

37 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Xolair Nov. 1, 2015 they supersede language in 5. Nighttime awakening more than once per week (Omalizumab) the benefit document or in the 6. Forced expiratory volume in one second (FEV1) or peak (continued) medical or drug policy expiratory flow PEF) ≤80% of predicted level  Updated supporting information 7. Measures of asthma control indicate uncontrolled asthma (e.g., to reflect the most current Asthma Control Test [ACT] score ≤19) clinical evidence and references and C. Baseline (pre-omalizumab treatment) serum total IgE level ≥ 30 IU/mL and ≤ 1500 IU/mL; and D. Positive skin test or in vitro reactivity to a perennial aeroallergen; and E. Documented failure (e.g., emergency room visit or hospitalization for asthma exacerbation, need for oral steroid burst) of at least 3 months to regular/routine treatment with one of the following: 1. One combination inhaled corticosteroid/long-acting beta2-agonist product [e.g., (fluticasone propionate/salmeterol (Advair®),mometasone/formoterol (Dulera®), budesonide/formoterol (Symbicort®)]; or 2. Combination therapy including both of the following: a. One inhaled corticosteroid at the maximum dosage [e.g.., fluticasone propionate (Flovent®), budesonide (Pulmicort®), beclomethasone dipropionate (QVAR®)]; and b. One long-acting beta2-agonist [e.g., formoterol fumarate (Foradil®), salmeterol xinafoate Serevent®)] ; and F. Prescribed by or in consultation with an allergist/immunologist or pulmonologist. 2. Xolair is proven and medically necessary as add-on therapy in children with severe persistent allergic asthma when all of the following criteria are met: A. Age 6 years to less than 12 years; and B. Diagnosis of severe persistent uncontrolled asthma as defined by one of the following: 1. Frequent daytime symptoms 2. Nighttime awakenings 3. Use of short-acting beta2-agonist several times per day for symptom control 4. Exacerbations limit/affect daily activity 5. Exacerbations (requiring use of oral systemic corticosteroids) ≥ 2/year;

38 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Xolair Nov. 1, 2015 and (Omalizumab) C. Baseline (pre-omalizumab treatment) serum total IgE level ≥ 30 (continued) IU/mL and ≤ 1500 IU/mL; and D. Documented failure (e.g., emergency room visit or hospitalization for asthma exacerbation, need for oral steroid burst) of at least 3 months to regular/routine treatment with one of the following: 1. One combination inhaled corticosteroid/long-acting beta2-agonist product [e.g., fluticasone propionate/salmeterol (Advair®), mometasone/formoterol (Dulera®), budesonide/formoterol (Symbicort®)] or 2. Combination therapy including both of the following: a. One inhaled corticosteroid at the maximum dosage [e.g., fluticasone propionate (Flovent®), budesonide (Pulmicort®), beclomethasone dipropionate (QVAR®)]; and b. One long-acting beta2-agonist [e.g., formoterol fumarate (Foradil®), salmeterol xinafoate (Serevent®)]; and E. Prescribed by or in consultation with an allergist/immunologist or pulmonologist. 3. Xolair is proven and medically necessary in chronic urticaria in adults and adolescents who meet both of the following criteria: A. Age 12 years or older; and B. Continues to remain symptomatic despite H1 antihistamine [e.g., cetirizine (Zyrtec), fexofenadine (Allegra)] treatment. Additional information to support medical necessity review: Omalizumab is medically necessary for treatment of chronic urticaria in adults and adolescents when all of the following criteria are met: A. Age 12 years or older; and B. One of the following: 1. *Patient remains symptomatic despite at least a 2-week trial of, or history of contraindication or intolerance to, two H1- antihistamines [e.g., Allegra (fexofenadine), Benadryl (diphenhydramine), Claritin (loratadine)]*; or 2. *Patient remains symptomatic despite at least a 2-week trial of, or history of contraindication or intolerance to both of the following taken in combination: a. Second generation H1-antihistamine [e.g., Allegra (fexofenadine), Claritin (loratadine), Zyrtec (cetirizine)]; and b. One of the following:

39 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Xolair Nov. 1, 2015 i. Different second generation H1-antihistamine [e.g., (Omalizumab) Allegra (fexofenadine), Claritin (loratadine), Zyrtec (continued) (cetirizine)] ii. First generation H1-antihistamine[e.g., Benadryl (diphenhydramine), Chlor-Trimeton (chlorpheniramine), Vistaril (hydroxyzine)]* iii. H2-antihistamine [e.g., Pepcid (famotidine), Tagamet HB (cimetidine), Zantac (ranitidine)] iv. Leukotriene modifier [e.g., Accolate (zafirlukast), Singulair (montelukast), Zyflo (zileuton)]

and C. Prescribed by or in consultation with an allergist/immunologist.

*Note: Patients 65 years of age and older in whom first generation H1- antihistamines are considered high risk medications to be avoided (e.g., Beers criteria, HEDIS) should be directed to try alternatives that are not considered high risk.

Xolair is unproven and not medically necessary in the following: 1. Seasonal allergic rhinitis 2. Perennial allergic rhinitis 3. Atopic dermatitis 4. Peanut allergy 5. Acute bronchospasm or status asthmaticus

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Abnormal Uterine Nov. 1, 2015  Added reference link to policy Levonorgestrel-Releasing Intrauterine Device Bleeding and titled Hysterectomy for Benign  The Mirena© (52 mg) levonorgestrel-releasing intrauterine device Uterine Fibroids Conditions (LNG-IUD) is proven and medically necessary for treating  Revised coverage rationale; menorrhagia in premenopausal women. added language to indicate the  The Skyla® (13.5 mg) LNG-IUD is unproven and not medically Skyla® (13.5 mg) necessary for treating menorrhagia. levonorgestrel-releasing There is insufficient clinical evidence in the published peer-reviewed intrauterine device (LNG-IUD) is medical literature demonstrating the safety and/or efficacy of this device unproven and not medically for treating menorrhagia. necessary for treating

40 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Abnormal Uterine Nov. 1, 2015 menorrhagia See the U.S. Food and Drug Administration (FDA) section of this policy for Bleeding and  Updated list of applicable HCPCS additional information. Uterine Fibroids codes for LNG-IUD; added J7301 (continued)  Updated supporting information Uterine Fibroids to reflect the most current  Uterine artery embolization (UAE) is proven and medically description of services, clinical necessary for treating symptomatic uterine fibroids for women evidence, FDA information, and who do NOT wish to preserve their childbearing potential. For references information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 19th edition, 2015, Uterine Artery Embolization, ACG: A-0287 (AC).  Uterine artery embolization (UAE) is unproven and not medically necessary for treating symptomatic uterine fibroids for women who wish to preserve their childbearing potential. The effects of UAE on ovarian and uterine function and on fertility are relatively unknown. Further studies of safety and/or efficacy in published, peer- reviewed medical literature are necessary.  Magnetic resonance imaging (MRI)-guided cryoablation is unproven and not medically necessary for treating uterine fibroids. The published evidence on MRI-guided cryoablation for uterine fibroids is very limited, as the procedure has been evaluated in very few patients. The long-term outcomes and overall health benefits remain unknown. Further long-term studies on larger samples published in peer- reviewed medical literature are necessary to demonstrate the safety and efficacy of this technology.  Magnetic resonance imaging (MRI)-guided focused ultrasound ablation (FUA) is unproven and not medically necessary for treating uterine fibroids. Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative to other treatments for uterine fibroids. See the Benefit Considerations section of this policy for potential coverage of unproven services.  Laparoscopic ultrasound-guided radiofrequency ablation is unproven and not medically necessary for treating uterine fibroids. Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative to other treatments for uterine fibroids.

41 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Botulinum Toxins A Nov. 1, 2015  Added reference links to policies Refer to the policy for complete details on the coverage guidelines for and B titled Temporomandibular Joint Botulinum Toxins A and B. Disorders and Occipital Neuralgia and Headache Treatment  Revised coverage rationale: o Updated general requirements (applicable to medical necessity review requests); clarified dosing frequency guidelines for botulinum toxin to specify administration is to be “no more frequent than every 12 weeks” o Added language to indicate if service is “proven” or “unproven” to applicable medically necessary/not medically necessary statements o Revised coverage rationale for Dysport: . Updated list of proven indications: - Added “blepharospasm associated with dystonia” - Replaced “strabismus and blepharospasm associated with dystonia” with “strabismus” . Removed references to language indicating criterion requiring failed prior therapy or intolerance to therapy does not apply to New Jersey plan members . Updated medical necessity

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Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Botulinum Toxins A Nov. 1, 2015 criteria for treatment of and B achalasia to (continued) reflect/include all of the following: - Diagnosis of achalasia as confirmed by esophageal manometry; and - Patient has failed or is not a candidate for pneumatic dilation or myotomy; and - History of failure, contraindication, or intolerance to one of the following:  Calcium channel blocker  Long-acting nitrate and - Other causes of dysphagia (e.g., peptic stricture, carcinoma, extrinsic compression) ruled out by upper gastrointestinal endoscopy . Updated medical necessity criteria for chronic anal fissures: - Modified criterion pertaining to failed prior therapy to reflect/include history of failure, contraindication, or intolerance to one of the following conventional therapies:  Topical nitrate

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Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Botulinum Toxins A Nov. 1, 2015  Topical calcium and B channel blocker (e.g., (continued) diltiazem, nifedipine) o Revised coverage rationale for Botox: . Updated list of proven indications: - Added “blepharospasm associated with dystonia” - Replaced “strabismus and blepharospasm associated with dystonia” with “strabismus” . Removed references to language indicating criterion requiring failed prior therapy or intolerance to therapy does not apply to New Jersey plan members . Updated medical necessity criteria for treatment of achalasia to reflect/include all of the following: - Diagnosis of achalasia as confirmed by esophageal manometry; and - Patient has failed or is not a candidate for pneumatic dilation or myotomy; and - History of failure, contraindication, or intolerance to one of the following:  Calcium channel

44 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Botulinum Toxins A Nov. 1, 2015 blocker and B  Long-acting nitrate (continued) and - Other causes of dysphagia (e.g., peptic stricture, carcinoma, extrinsic compression) ruled out by upper gastrointestinal endoscopy . Updated medical necessity criteria for chronic anal fissures: - Modified criterion pertaining to failed prior therapy to require history of failure, contraindication, or intolerance to one of the following conventional therapies:  Topical nitrate  Topical calcium channel blocker (e.g., diltiazem, nifedipine) . Updated medical necessity criteria for prophylaxis of chronic migraine: - Modified criterion pertaining to failed prior therapy to require history of failure (after a trial of at least two months), contraindication, or intolerance to prophylactic therapy with one agent from

45 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Botulinum Toxins A Nov. 1, 2015 two of the following and B therapeutic classes: (continued)  Antidepressant [i.e., Elavil (amitriptyline), Effexor (venlafaxine)]  Antiepileptic drug [i.e., Depakote/Depakote ER (divalproex sodium), Topamax (topiramate)]  Beta blocker [i.e., atenolol, Inderal (propranolol), nadolol, timolol, Toprol XL (metoprolol extended-release)] - Added criterion requiring OnabotulinumtoxinA dose does not exceed 155 units administered intramuscularly divided over 31 injection sites divided across 7 head and neck muscles every 12 weeks o Revised coverage rationale for Myobloc: . Updated medical necessity criteria for treatment of detrusor overactivity (also known as detrusor hyperreflexia): - Removed reference to language indicating criterion requiring failed prior therapy or intolerance to therapy

46 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Botulinum Toxins A Nov. 1, 2015 does not apply to New and B Jersey plan members (continued)  Updated benefit considerations: o Added language to indicate; . Most Oxford Certificates of Coverage (COCs) exclude benefit coverage for cosmetic services . The member specific benefit document must be reviewed to determine what benefits, if any, exist for treatment of hyperhidrosis . For Essential Health Benefits for Individual and Small Group plans: - For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”) - Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide

47 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Botulinum Toxins A Nov. 1, 2015 coverage for benefits and B which are deemed EHBs (continued) (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non- Grandfathered plans - The determination of which benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the member specific benefit document to determine benefit coverage o Removed language indicating the State of New Jersey prohibits requiring failed prior therapy or intolerance to therapy as a requirement for coverage  Updated supporting information to reflect the most current clinical evidence, FDA information, and references Clotting Factors Nov. 1, 2015  Revised coverage rationale: Refer to the policy for complete details on the coverage guidelines for and Coagulant o Updated list of coagulant Clotting Factors and Coagulant Blood Products. Blood Products blood products addressed in the policy; added IXINITY®

coagulation factor IX (recombinant) o Updated coverage criteria for treatment of Hemophilia B (i.e., Congenital Factor IX

48 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Clotting Factors Nov. 1, 2015 Deficiency, Christmas and Coagulant Disease); added IXINITY to Blood Products list of applicable Factor IX (continued) (recombinant) products  Updated supporting information to reflect the most current FDA information and references Drug Coverage Nov. 1, 2015  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 Finacea 15% Foam, FlowTuss, Histex-AC Syrup, Hycofenix, Repatha, Zecuity 6.5mg/4 hr patch, and Zarxio o Removed Fluorac Cream, Movantik, and Savaysa

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Sep. 10, 2015 Praluent (Alirocumab) Revised  Revised coverage guidelines (refer to Praluent (alirocumab) for complete Guidelines details): o Revised coverage criteria for initial therapy to indicate Praluent will be approved based on all of the following criteria (authorization will be

issued for 6 months):

. Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following diagnoses: - Heterozygous familial hypercholesterolemia (HeFH) as confirmed by both of the following*:  Pre-treatment LDL-C greater than 190 mg/dL (greater than 155 mg/dL if less than 16 years of age)  Pre-treatment LDL-C greater than 190 mg/dL in adult first- or

second degree relative or - Atherosclerotic cardiovascular disease (ASCVD) as confirmed by one of the following:  Acute coronary syndromes  History of myocardial infarction

49 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Sep. 10, 2015 Praluent (Alirocumab) Revised  Stable or unstable angina Guidelines (continued)  Coronary or other arterial revascularization (continued)  Stroke  Transient ischemic attack

 Peripheral arterial disease presumed to be of atherosclerotic

origin and . Submission of medical records (e.g., chart notes, laboratory values) documenting one of the following: - Patient has been receiving at least 12 consecutive weeks of high intensity statin therapy and will continue to receive high-intensity statin [i.e. atorvastatin 40-80 mg, Crestor (rosuvastatin) 20-40

mg] at maximally tolerated dose; or

- Both of the following:  Patient is unable to tolerate high-intensity statin as evidenced by one of the following intolerable and persistent (i.e. more than 2 weeks) symptoms: o Myalgia (muscle symptoms without CK elevations) o Myositis (muscle symptoms with CK elevations < 10 times upper limit of normal [ULN])

and  Patient has been receiving at least 12 consecutive weeks of moderate-intensity statin therapy and will continue to receive a moderate-intensity statin [i.e. atorvastatin 10-20 mg, Crestor (rosuvastatin) 5-10 mg, simvastatin ≥ 20 mg,

pravastatin ≥ 40 mg, lovastatin 40 mg, Lescol XL (fluvastatin XL) 80 mg, fluvastatin 40 mg twice daily or Livalo

(pitavastatin) ≥ 2 mg] at maximally tolerated dose or - Both of the following:  Patient is unable to tolerate moderate- and high-intensity statin as evidenced by one of the following intolerable and persistent (i.e. more than 2 weeks) symptoms:

o Myalgia (muscle symptoms without CK elevations) o Myositis (muscle symptoms with CK elevations < 10 times

upper limit of normal [ULN]) and  Patient has been receiving at least 12 consecutive weeks of

50 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Sep. 10, 2015 Praluent (Alirocumab) Revised lowintensity statin therapy and will continue to receive a Guidelines (continued) lowintensity statin [i.e. imvastatin 10 mg, pravastatin 10- (continued) 20 mg, lovastatin 20 mg, fluvastatin 20-40 mg, or Livalo (pitavastatin) 1 mg] at maximally tolerated dose

- Patient is unable to tolerate low-, moderate-, and high- intensity statins as evidenced by both of the following:  One of the following intolerable and persistent (i.e. more than 2 weeks) symptoms for low-, moderate-, and high-intensity statins: o Myalgia (muscle symptoms without CK elevations) o Myositis (muscle symptoms with CK elevations < 10 times

upper limit of normal [ULN]) and  Patient has undergone a trial of statin rechallenge with another low-intensity statin with documented reappearance of muscle symptoms or - Patient has a labeled contraindication to all statins as documented in medical records; or

- Patient has experienced rhabdomyolysis or muscle symptoms with statin treatment with CK elevations > 10 times ULN and . Submission of medical record (e.g., chart notes, laboratory values) documenting one of the following : - Patient has been receiving at least 12 consecutive weeks of Zetia

(ezetimibe) therapy as adjunct to maximally tolerated statin therapy and will continue to receive Zetia; or

- Patient has a history of contraindication, or intolerance to Zetia

and . Submission of medical record (e.g., laboratory values) documenting one of the following LDL-C values while on maximally tolerated lipid lowering therapy within the last 30 days: - LDL-C ≥ 100 mg/dL with ASCVD

- LDL-C ≥ 130mg/dL without ASCVD and

. Used as an adjunct to a low-fat diet and exercise; and

. Prescribed by one of the following:

51 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Sep. 10, 2015 Praluent (Alirocumab) Revised - Cardiologist Guidelines (continued) - Endocrinologist (continued) - Lipid specialist and . Not used in combination with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor *Results of prior genetic testing can be submitted as confirmation of diagnosis of HeFH, however please note that UnitedHealthcare does not currently cover genetic testing for evidence of an LDL-receptor mutation, familial defective apo B-100 or a PCSK9 mutation. o Revised coverage criteria for reauthorization to indicate Praluent will be approved based on all of the following criteria (authorization will be issued for 12 months): . Patient continues to receive statin at maximally tolerated dose (unless patient has documented inability to take statins); and . Patient continues to receive Zetia as an adjunct to maximally tolerated statin therapy (unless patient has documented inability to take Zetia); and . Patient is continuing a low-fat diet and exercise regimen; and . Prescribed by one of the following: - Cardiologist - Endocrinologist - Lipid specialist and . Submission of medical records (e.g. chart notes, laboratory values) documenting LDL-C reduction while on Praluent therapy; and . Not used in combination with another proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor Repatha (Evolocumab) New  Added coverage guidelines (precertification requirements apply); refer to Repatha for complete details on applicable coverage criteria Drug Coverage Oct. 1, 2015 Actimmune (interferon Updated  Reformatted policy content (refer to Actimmune (interferon gamma-1b)); Guidelines gamma-1b) no change to coverage guidelines/criteria Drug Coverage Nov. 1, 2015 Actimmune (Interferon Revised  Revised coverage guidelines (refer to Actimmune (interferon gamma-1b) Guidelines Gamma-1b) for complete details on applicable coverage criteria): o Revised coverage criteria for patients less than 19 years of age; added criterion requiring patient has oncology diagnosis o Changed initial authorization and reauthorization approval timeframe for all indications from “6 months” to “12 months”

52 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Afinitor (Everolimus) Revised  Revised coverage guidelines (refer to Afinitor for complete details on Guidelines applicable coverage criteria): (continued) o Changed initial authorization and reauthorization approval timeframe for all indications from “5 months” to “12 months”

o Revised initial authorization criteria for treatment of Waldenströms

Macroglobulinemia or Lymphoplasmacytic Lymphoma (off- label); added criterion requiring: . Disease is non-responsive to primary treatment . Disease is progressive . Disease is relapsed o Revised initial authorization criteria for treatment of Lung Neuroendocrine Tumors (off-label); added criterion requiring both

of the following: . Disease is stage IIIb (T4 due to multiple lung nodules) to stage IV . Disease is low-grade to intermediate-grade o Revised initial authorization for treatment of breast cancer to indicate approval will be based on the all of the following criteria: . Diagnosis of breast cancer; and . One of the following: - Disease is recurrent; or

- Disease is metastatic and . Disease is hormone receptor positive (HR+); and . Disease is human epidermal growth factor receptor 2 (HER2)- negative; and . Patient is a postmenopausal woman; and

. One of the following:

- Disease progressed while on or within 12 months of non-steroidal aromatase inhibitor [e.g., Arimidex (anastrozole), Femara

(letrozole)] therapy; or - Patients was treated with tamoxifen at any time and

. Used in combination with Aromasin (exemestane)

o Revised initial authorization criteria for treatment of Hodgkin

Lymphoma (off-label) to indicate approval will be based on the both

of the following criteria:

. Diagnosis of classical Hodgkin lymphoma; and

. One of the following:

53 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Afinitor (Everolimus) Revised - Disease is refractory Guidelines (continued) - Disease is relapsed (continued) Avodart (Dutasteride) Updated  Routine review; updated background information and references (no change to coverage guidelines) Banzel (Rufinamide) Updated  Routine review; updated background information and references (no change to coverage guidelines) Berinert (C1 Esterase Updated  Routine review; updated references (no change to coverage guidelines) Inhibitor Human) Bravelle (Urofollitropin) Revised  Revised coverage guidelines (refer to Follicle Stimulating Hormone (FSH) Gonadotropins for complete details on applicable coverage criteria) o Revised authorization requirements to indicate precertification is performed by Optum o Updated reference links to related policies: . Removed/replaced reference link to policy titled Follicle Stimulating Hormones (FSH) used in the Treatment of Infertility . Added reference link to policy titled Follicle Stimulating Hormone (FSH) Gonadotropins Brilinta (Ticagrelor) Revised  Revised coverage guidelines (refer to Brilinta (Ticagrelor) for complete

details on applicable coverage criteria): o Changed initial authorization approval timeframe from “12 months unless there is a new episode of acute coronary syndrome” to “12 months” Caprelsa (Vandetanib) Revised  Revised coverage guidelines for the treatment of thyroid carcinoma (refer

to Caprelsa for complete details on applicable coverage criteria):

o Updated condition description/sub-header; previous titled medullary thyroid cancer (MTC)

o Revised initial authorization criteria to indicate approval will be based on one of the following: . Both of the following criteria: - One of the following diagnoses:  Metastatic medullary thyroid cancer (MTC)

 Unresectable locoregional MTC and

- One of the following:

 Disease is progressive

 Disease is symptomatic

. All of the following criteria:

54 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Caprelsa (Vandetanib) Revised - One of the following diagnosis: Guidelines (continued)  Follicular Carcinoma (continued)  Hürthle Cell Carcinoma

 Papillary Carcinoma and

- One of the following:  Unresectable recurrent  Persistent locoregional disease  Metastatic disease and - One of the following:  Patient has symptomatic disease  Patient has progressive disease and

- Disease is refractory to radioactive iodine treatment

Cinryze (C1 Esterase Updated  Routine review; no content changes Inhibitor (Human)) Cometriq (Cabozantinib) Revised  Revised coverage guidelines (refer to Cometriq for complete details on applicable coverage criteria): o Changed initial authorization approval timeframe for all indications from “11 months” to “12 months” o Changed reauthorization approval timeframe for all indications from “11 months” to “12 months”  Revised authorization duration to 12 months for all conditions; previously 11 months Daklinza (Daclatasvir) New  Added coverage guidelines (precertification requirements apply); refer to the following policies for complete details on applicable coverage criteria: o For CT and NY plan members: Daklinza - CT/NY o For NJ plan members: Daklinza - NJ Evista (Raloxifene) Revised  Revised coverage guidelines (refer to Evista for complete details on (Brand Only) applicable coverage criteria): o Updated coverage criteria for approval of copayment deduction; removed criterion requiring member is female Finacea 15% Foam New  Added coverage guidelines (precertification requirements apply); refer to (Azelaic Acid) Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details on applicable coverage criteria Firazyr (Icatibant) Updated  Routine review; no content changes

55 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Flowtuss (Hydrocodone/ New  Added coverage guidelines (precertification requirements apply); refer to Guidelines Guaifenesin) Drug Coverage Criteria - New and Therapeutic Equivalent Medications for (continued) complete details on applicable coverage criteria Follistim AQ (Follitropin Revised  Revised coverage guidelines (refer to Follicle Stimulating Hormone (FSH) Beta) Gonadotropins for complete details on applicable coverage criteria) o Revised authorization requirements to indicate precertification is performed by Optum o Updated reference links to related policies: . Removed/replaced reference link to policy titled Follicle Stimulating Hormones (FSH) used in the Treatment of Infertility . Added reference link to policy titled Follicle Stimulating Hormone (FSH) Gonadotropins Genotropin (Somatropin) Revised  Revised coverage guidelines (refer to Genotropin (somatropin) for complete details on applicable coverage criteria): o Updated initial therapy and reauthorization criteria for treatment of pediatric growth hormone deficiency (GHD), adult growth hormone

deficiency and transition phase adolescent patients:

. Removed/replaced criterion requiring GH is dosed according to FDA approved labeling for growth hormone deficiency . Added criterion indicating with coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week: o Updated initial therapy and reauthorization criteria for the treatment of idiopathic short stature for the state of Maryland only; added criterion indicating coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week Gonal-F (Follitropin Alfa) Revised  Revised coverage guidelines (refer to Follicle Stimulating Hormone (FSH) Gonadotropins for complete details on applicable coverage criteria) o Revised authorization requirements to indicate precertification is performed by Optum o Updated reference links to related policies: . Removed/replaced reference link to policy titled Follicle Stimulating Hormones (FSH) used in the Treatment of Infertility . Added reference link to policy titled Follicle Stimulating Hormone (FSH) Gonadotropins Harvoni ™ Revised  Revised coverage guidelines for CT and NY plan members (refer to (Ledipasvir/Sofosbuvir) Harvoni™ (ledipasvir/ sofosbuvir) - CT/NY for complete details on applicable coverage criteria) o Added coverage criteria for treatment of chronic hepatitis C

56 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Harvoni ™ Revised genotype 4 infection to indicate authorization (for 12 weeks) will be Guidelines (Ledipasvir/Sofosbuvir) approved based on all of the following criteria: (continued) (continued) . Both of the following: - Submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 4 infection; and - One of the following:  Submission of medical records (e.g., chart notes, laboratory values) documenting stage 3 or 4 hepatic fibrosis including one of the following: o Liver biopsy confirming a METAVIR score of F3 or F4, or alternative scoring equivalent*; or o Transient elastography (Fibroscan) score greater than or equal to 9.5 kPa; or o FibroTest (FibroSURE) score of greater than or equal to 0.58; or o APRI score greater than 1.5 or  Documentation that the patient is taking immunosuppressant therapy following organ transplantation; or  Submission of medical records (e.g., chart notes, laboratory values) documenting that patient has serious extrahepatic manifestations of HCV infection (i.e., leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, proteinuria, nephrotic syndrome or symptomatic cryoglobulinemia); or  Patient is co-infected with HIV and . Prescribed by one of the following: - Hepatologist - Gastroenterologist - Infectious Disease Specialist - HIV Specialist Certified through the Academy of HIV Medicine and . One of the following: - Patient has no known history of illicit drug abuse or alcohol abuse; or - For a patient with a known prior history of illicit drug abuse or

57 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Harvoni ™ Revised alcohol abuse: Guidelines (Ledipasvir/Sofosbuvir)  Patient has abstained from the use of illicit drugs and alcohol (continued) (continued) abuse for the past 6 months; and  For a patient with a prior history of illicit drug abuse, submission of a negative urine drug screen collected within 30 days prior to onset of treatment and . Patient is not receiving Harvoni in combination with another HCV direct acting antiviral agent [eg, Sovaldi (sofosbuvir), Olysio (simeprevir)]  Revised coverage guidelines for NJ plan members (refer to Harvoni™ (ledipasvir/sofosbuvir) - NJ for complete details on applicable coverage criteria): o Revised documentation requirements for all applicable indications; . Removed scoring outcome requirement for: - Liver biopsy - Transient elastography (Fibroscan) - FibroTest (FibroSURE) score - APRI o Revised coverage criteria for treatment of chronic hepatitis C genotype 1 infection in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA less than 6 million IU/mL; removed criterion requiring submission of medical records (e.g., chart notes, laboratory values) documenting that patient has serious extrahepatic manifestations of HCV infection (i.e., leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, proteinuria, nephrotic syndrome or symptomatic cryoglobulinemia) o Revised coverage criteria for treatment of chronic hepatitis C genotype 1a or mixed genotype 1 infection in treatment-naïve patients without cirrhosis who have pre-treatment HCV RNA equal to or greater than 6 million IU/mL OR Post Transplant OR co-infected with HIV; removed criterion requiring:

. Submission of medical records (e.g., chart notes, laboratory values)

documenting that patient has serious extrahepatic manifestations of

HCV infection (i.e., leukocytoclastic vasculitis, membranoproliferative

glomerulonephritis, proteinuria, nephrotic syndrome or symptomatic

cryoglobulinemia)

. Documentation that the patient is taking immunosuppressant

58 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Harvoni ™ Revised therapy for a non-hepatic (liver) organ transplant (e.g., heart, Guidelines (Ledipasvir/Sofosbuvir) kidney, lungs) (continued) (continued) o Revised coverage criteria for treatment of chronic hepatitis C genotype 1 infection in treatment-naïve patients with cirrhosis and treatment of chronic hepatitis C genotype 1 infection in treatment-experienced patients with cirrhosis: . Added criterion requiring submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 1 infection with cirrhosis (i.e., Metavir score of F4) . Removed criterion requiring submission of medical records (e.g., chart notes, laboratory values) documenting stage 4 hepatic fibrosis o Revised coverage criteria for treatment of chronic hepatitis C genotype 1 infection in treatment-experienced patients without cirrhosis; removed criterion requiring: . Submission of medical records (e.g., chart notes, laboratory values) documenting that patient has serious extrahepatic manifestations of HCV infection (i.e., leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, proteinuria, nephrotic syndrome or symptomatic cryoglobulinemia) . Documentation that the patient is taking immunosuppressant therapy for a non-hepatic (liver) organ transplant (e.g., heart, kidney, lungs) . Patient is co-infected with HIV o Added coverage criteria for treatment of chronic hepatitis C genotype 4 infection to indicate authorization will be approved (for 12 weeks) based on all of the following criteria:

. Both of the following:

Submission of medical records (e.g., chart notes, laboratory - values) documenting diagnosis of chronic hepatitis C genotype 4

infection; and

- One of the following:  Submission of medical records (e.g., chart notes, laboratory values) documenting stage of liver disease including, but not limited to, one of the following: o Liver biopsy; or o Transient elastography (Fibroscan) score; or o FibroTest (FibroSURE) score; or o APRI score

59 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Harvoni ™ Revised and Guidelines (Ledipasvir/Sofosbuvir) . Prescribed by one of the following: (continued) (continued) - Hepatologist

- Gastroenterologist - Infectious Disease Specialist - HIV Specialist Certified through the Academy of HIV Medicine and . One of the following: - Patient has no known history of illicit drug abuse or alcohol abuse; or - For a patient with a known prior history of illicit drug abuse or alcohol abuse:  Patient has abstained from the use of illicit drugs and alcohol abuse for the past 6 months; and  For a patient with a prior history of illicit drug abuse, submission of a negative urine drug screen collected within 30 days prior to onset of treatment . Patient is not receiving Harvoni in combination with another HCV direct acting antiviral agent [e.g., Sovaldi (sofosbuvir), Olysio (simeprevir)] Histex-AC Syrup New  Added coverage guidelines (precertification requirements apply); refer to (Codeine/Phenylephrine/ Drug Coverage Criteria - New and Therapeutic Equivalent Medications for Triprolidine) complete details on applicable coverage criteria Humatrope (Somatropin) Revised  Revised coverage guidelines (refer to Humatrope (somatropin) for complete details on applicable coverage criteria):

o Updated initial therapy and reauthorization criteria for treatment of pediatric growth hormone deficiency (GHD), adult growth hormone

deficiency and transition phase adolescent patients: . Removed/replaced criterion requiring GH is dosed according to FDA approved labeling for growth hormone deficiency . Added criterion indicating with coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week: o Updated initial therapy and reauthorization criteria for the treatment of idiopathic short stature for the state of Maryland only; added criterion indicating coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week Humira (Adalimumab) Revised  Revised coverage guidelines (refer to Humira (adalimumab) for complete

60 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Humira (Adalimumab) Revised details on applicable coverage criteria): Guidelines (continued) o Removed step therapy criteria (continued) o Removed reference link to policy titled Step Therapy: Humira (adalimumab) Hycofenix New  Added coverage guidelines (precertification requirements apply); refer to (Hydrocodone/ Drug Coverage Criteria - New and Therapeutic Equivalent Medications for Pseudoephedrine/ complete details on applicable coverage criteria Guaifenesin) Inlyta (Axitinib) Revised  Revised coverage guidelines (refer to Inlyta for complete details on applicable coverage criteria): o Changed initial authorization and reauthorization approval timeframe for all indications from “7 months” to “12 months”

o Added coverage criteria for treatment of thyroid carcinoma to indicate: . Initial authorization will be approved for 12 months based on all of the following criteria: - One of the following diagnosis:  Follicular Carcinoma  Hürthle Cell Carcinoma  Papillary Carcinoma and - One of the following:  Unresectable recurrent  Persistent locoregional disease  Metastatic disease and

- Disease is refractory to radioactive iodine treatment

. Reauthorization will be approved (for 12 months) based on the

following criterion:

- Patient does not show evidence of progressive disease while on

Inlyta therapy

Menopur (Menotropins) Revised  Revised coverage guidelines (refer to Human Menopausal Gonadotropins

(hMG) for complete details on applicable coverage criteria):

o Revised authorization requirements to indicate precertification is

performed by Optum

o Updated reference links to related policies:

. Added Human Menopausal Gonadotropins (hMG)

. Removed Human Menopausal Gonadotropins (hMG) Used in the

61 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Menopur (Menotropins) Revised Treatment of Infertility Guidelines (continued) (continued) Movantik (Naloxegol) Revised  Revised coverage guidelines to indicate precertification is no longer required  Removed reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Nexavar Revised  Revised coverage guidelines (refer to Nexavar for complete details on (Sorafenib Tosylate) applicable coverage criteria): o Changed initial authorization and reauthorization approval timeframe for all indications from “6 months” to “12 months”

o Revised initial authorization criteria for treatment of thyroid cancer:

. Replaced criterion requiring “locally recurrent disease” with; - Unresectable recurrent disease; or - Persistent locoregional disease . Replaced criterion requiring “patient has symptomatic disease” with one of the following:

- Disease is progressive; or

- Disease is symptomatic with distant metastases o Revised initial authorization criteria for treatment of soft tissue

sarcoma (off-label); added criterion (option) requiring both of the following: . Diagnosis of progressive gastrointestinal stromal tumors (GIST); and . History of failure, contraindication, or intolerance to one of the following:

- Gleevec (imatinib)

- Sutent (sunitinib) - Stivarga (regorafenib)

o Removed coverage criteria for treatment of gastrointestinal stromal tumors (GIST) (off-label) o Revised initial authorization criteria for treatment of osteosarcoma (off-label); added criterion requiring Nexavar is not used as first-line therapy

o Added coverage criteria for treatment of acute myeloid leukemia

(off-label) to indicate: . Initial authorization will be approved (for 12 months) based on all of

the following criteria: - Diagnosis of acute myeloid leukemia (AML); and - Patient has FLT3-ITD mutation-positive disease; and

62 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Nexavar Revised - One of the following: Guidelines (Sorafenib Tosylate)  Patient has relapsed disease (continued) (continued)  Patient has refractory disease and - Used in combination with one of the following:  Vidaza (azacitidine)  Dacogen (decitabine) and - Patient is unable to tolerate more aggressive treatment regimens . Reauthorization will be approved (for 12 months) based on the following criterion:

- Patient does not show evidence of progressive disease while on

Nexavar therapy

Norditropin AQ Revised  Revised coverage guidelines (refer to Norditropin (somatropin) for

(Somatropin) complete details on applicable coverage criteria):

o Updated initial therapy and reauthorization criteria for treatment of

pediatric growth hormone deficiency (GHD), adult growth hormone

deficiency and transition phase adolescent patients:

. Removed/replaced criterion requiring GH is dosed according to FDA

approved labeling for growth hormone deficiency

. Added criterion indicating with coverage will be provided up to a

maximum supply limit of 0.3 mg/kg/week:

o Updated initial therapy and reauthorization criteria for the treatment of

idiopathic short stature for the state of Maryland only; added criterion

indicating coverage will be provided up to a maximum supply limit of

0.3 mg/kg/week

Norditropin (Somatropin) Revised  Revised coverage guidelines (refer to Norditropin (somatropin) for

complete details on applicable coverage criteria):

o Updated initial therapy and reauthorization criteria for treatment of

pediatric growth hormone deficiency (GHD), adult growth hormone

deficiency and transition phase adolescent patients:

. Removed/replaced criterion requiring GH is dosed according to FDA

approved labeling for growth hormone deficiency

. Added criterion indicating with coverage will be provided up to a

maximum supply limit of 0.3 mg/kg/week:

o Updated initial therapy and reauthorization criteria for the treatment of

idiopathic short stature for the state of Maryland only; added criterion

indicating coverage will be provided up to a maximum supply limit of

63 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Norditropin (Somatropin) Revised 0.3 mg/kg/week Guidelines (continued) (continued) Norditropin Nordiflex Revised  Revised coverage guidelines (refer to NordiFlex (somatropin) for complete (Somatropin) details on applicable coverage criteria): o Updated initial therapy and reauthorization criteria for treatment of pediatric growth hormone deficiency (GHD), adult growth hormone deficiency and transition phase adolescent patients: . Removed/replaced criterion requiring GH is dosed according to FDA approved labeling for growth hormone deficiency . Added criterion indicating with coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week: o Updated initial therapy and reauthorization criteria for the treatment of idiopathic short stature for the state of Maryland only; added criterion indicating coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week Nuspin (Somatropin) Revised  Revised coverage guidelines (refer to NuSpin (somatropin) for complete details on applicable coverage criteria): o Updated initial therapy and reauthorization criteria for treatment of pediatric growth hormone deficiency (GHD), adult growth hormone

deficiency and transition phase adolescent patients: . Removed/replaced criterion requiring GH is dosed according to FDA approved labeling for growth hormone deficiency . Added criterion indicating with coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week: o Updated initial therapy and reauthorization criteria for the treatment of idiopathic short stature for the state of Maryland only; added criterion indicating coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week Nutropin and Nutropin Revised  Revised coverage guidelines (refer to Nutropin and Nutropin AQ AQ (Somatropin) (somatropin) for complete details on applicable coverage criteria):

o Updated initial therapy and reauthorization criteria for treatment of pediatric growth hormone deficiency (GHD), adult growth hormone

64 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Nutropin and Nutropin Revised indicating coverage will be provided up to a maximum supply limit of Guidelines AQ (Somatropin) 0.3 mg/kg/week (continued) (continued) Olysio (Simeprevir) Revised  Revised coverage guidelines for NJ plan members (refer to Olysio for NJ for complete details on applicable coverage criteria): o Revised documentation requirements for all applicable indications; . Removed scoring outcome requirement for:

- Liver biopsy

- Transient elastography (Fibroscan) - FibroTest (FibroSURE) score - APRI o Revised coverage criteria for treatment of chronic hepatitis C genotype 1 infection in peginterferon eligible patients; removed criterion requiring:

. Radiological imaging consistent with cirrhosis (e.g., evidence of portal hypertension) to document stage of liver disease

. Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician to document stage of liver disease o Revised coverage criteria for treatment of chronic hepatitis C genotype 1 infection without cirrhosis; removed criterion

requiring: . Submission of medical records (e.g., chart notes, laboratory values)

documenting that patient has serious extrahepatic manifestations of

HCV infection (i.e., leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, proteinuria, nephrotic syndrome or symptomatic cryoglobulinemia) . Documentation that the patient is taking immunosuppressant therapy for a non-hepatic (liver) organ transplant (e.g., heart,

kidney, lungs) . Patient is co-infected with HIV

o Revised coverage criteria for treatment of chronic hepatitis C genotype 1 infection with cirrhosis: . Added criterion requiring submission of medical records (e.g., chart notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 1 infection with cirrhosis (i.e., Metavir score of F4) . Removed criterion requiring submission of medical records (e.g.,

chart notes, laboratory values) documenting stage 4 hepatic fibrosis

65 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Olysio (Simeprevir) Revised  Revised coverage guidelines for Hepatitis C Direct Acting Antivirals Guidelines (continued) (refer to Hepatitis C Direct Acting Antivirals for complete details on (continued) applicable coverage criteria): o Updated coverage criteria; changed service/indication guideline header from “Chronic Hepatitis C” to “Chronic Hepatitis C Genotype 1” Omnitrope Revised  Revised coverage guidelines (refer to Omnitrope (somatropin) for (Somatropin) complete details on applicable coverage criteria): o Updated initial therapy and reauthorization criteria for treatment of pediatric growth hormone deficiency (GHD), adult growth hormone deficiency and transition phase adolescent patients: . Removed/replaced criterion requiring GH is dosed according to FDA approved labeling for growth hormone deficiency . Added criterion indicating with coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week: o Updated initial therapy and reauthorization criteria for the treatment of idiopathic short stature for the state of Maryland only; added criterion indicating coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week Onfi (Clobazam) Updated  Routine review; updated background information and references (no change to coverage guidelines) Oxistat (Oxiconazole Updated  Routine review; updated background information and references (no Nitrate) change to coverage guidelines) Potiga (Ezogabine) Updated  Routine review; updated background information and references (no change to coverage guidelines) Repatha (Evolocumab) Revised  Revised coverage guidelines (refer to Repatha for complete details on applicable coverage criteria):

o Revised coverage criteria for treatment of primary hyperlipidemia; added criterion requiring history of intolerance or therapeutic failure to

treatment with atorvastatin (generic Lipitor), simvastatin (generic Zocor), pravastatin (generic Pravachol) or Crestor o Added reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Repronex (Menotropins) Revised  Revised coverage guidelines (refer to Human Menopausal Gonadotropins

(hMG) for complete details on applicable coverage criteria):

o Revised authorization requirements to indicate precertification is performed by Optum

o Updated reference links to related policies:

. Added Human Menopausal Gonadotropins (hMG)

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Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Repronex (Menotropins) Revised . Removed Human Menopausal Gonadotropins (hMG) Used in the Guidelines (continued) Treatment of Infertility (continued) Ruconest (C1 Esterase Updated  Routine review; updated references (no change to coverage guidelines) Inhibitor [Recombinant]) Saizen (Somatropin) Revised  Revised coverage guidelines (refer to Saizen (somatropin) for complete details on applicable coverage criteria): o Updated initial therapy and reauthorization criteria for treatment of pediatric growth hormone deficiency (GHD), adult growth hormone deficiency and transition phase adolescent patients: . Removed/replaced criterion requiring GH is dosed according to FDA approved labeling for growth hormone deficiency . Added criterion indicating with coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week: o Updated initial therapy and reauthorization criteria for the treatment of idiopathic short stature for the state of Maryland only; added criterion indicating coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week Savaysa (Edoxaban) Revised  Revised coverage guidelines to indicate precertification is no longer required  Removed reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Serostim (Somatropin) Revised  Revised coverage guidelines (refer to Serostim (somatropin) for complete details on applicable coverage criteria): o Updated initial therapy and reauthorization criteria for treatment of pediatric growth hormone deficiency (GHD), adult growth hormone deficiency and transition phase adolescent patients: . Removed/replaced criterion requiring GH is dosed according to FDA approved labeling for growth hormone deficiency . Added criterion indicating with coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week: o Updated initial therapy and reauthorization criteria for the treatment of idiopathic short stature for the state of Maryland only; added criterion indicating coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week Soltamox (Tamoxifen Revised  Revised coverage guidelines (refer to Soltamox for complete details on Citrate) applicable coverage criteria): o Updated coverage criteria for approval of copayment deduction; removed criterion requiring member is female

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REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Sovaldi (Sofosbuvir) Revised  Revised coverage guidelines for NJ plan members (refer to Sovaldi - NJ Guidelines for complete details on applicable coverage criteria): (continued) o Revised documentation requirements for all applicable indications; . Removed scoring outcome requirement for:

- Liver biopsy

- Transient elastography (Fibroscan) - FibroTest (FibroSURE) score - APRI o Revised coverage criteria for treatment of chronic hepatitis C (without decompensation) genotype 1 infection in peginterferon eligible patients, treatment of chronic hepatitis C

genotype 2 infection (without decompensation), treatment of chronic hepatitis C genotype 3 infection in peginterferon eligible

patients and treatment of chronic hepatitis C genotype 4 infection (without decompensation) in peginterferon eligible patients; removed criterion requiring: . Radiological imaging consistent with cirrhosis (e.g., evidence of portal hypertension) to document stage of liver disease . Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician to document stage of liver

disease

. Submission of medical records (e.g., chart notes, laboratory values) documenting that patient has serious extrahepatic manifestations of HCV infection (i.e., leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, proteinuria, nephrotic syndrome or symptomatic cryoglobulinemia)

. Patient is co-infected with HIV . Documentation that the patient is taking immunosuppressant

therapy for a non-hepatic (liver) organ transplant (e.g., heart, kidney, lungs) o Revised coverage criteria for treatment of chronic hepatitis C (without decompensation) genotype 1 infection without cirrhosis; removed criterion requiring: . Submission of medical records (e.g., chart notes, laboratory values)

documenting that patient has serious extrahepatic manifestations of HCV infection (i.e., leukocytoclastic vasculitis, membranoproliferative

glomerulonephritis, proteinuria, nephrotic syndrome or symptomatic cryoglobulinemia) . Documentation that the patient is taking immunosuppressant

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REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Sovaldi (Sofosbuvir) Revised therapy for a non-hepatic (liver) organ transplant Guidelines (continued) . Patient is co-infected with HIV (continued) o Revised coverage criteria for treatment of chronic hepatitis C (without decompensation) genotype 1 infection with cirrhosis:

. Added criterion requiring submission of medical records (e.g., chart

notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 1 infection with cirrhosis (i.e., Metavir score of F4) . Removed criterion requiring submission of medical records (e.g., chart notes, laboratory values) documenting stage 4 hepatic fibrosis o Revised coverage criteria for treatment of chronic hepatitis C (without decompensation) genotype 1 infection in peginterferon ineligible patients, treatment of chronic hepatitis

C genotype 3 infection (without decompensation) in peginterferon ineligible patients and treatment of chronic hepatitis C genotype 4 infection (without decompensation) in peginterferon ineligible patients; removed criterion requiring: . Radiological imaging consistent with cirrhosis (e.g., evidence of portal hypertension) to document stage of liver disease . Physical findings or clinical evidence consistent with cirrhosis as attested by the prescribing physician to document stage of liver

disease . Submission of medical records (e.g., chart notes, laboratory values) documenting that patient has serious extrahepatic manifestations of HCV infection (i.e., leukocytoclastic vasculitis, membranoproliferative glomerulonephritis, proteinuria, nephrotic syndrome or symptomatic cryoglobulinemia) . Patient is co-infected with HIV

 Revised coverage guidelines for Hepatitis C Direct Acting Antiviral (refer to Hepatitis C Direct Acting Antivirals for complete details on applicable coverage criteria): o Updated coverage criteria; changed service/indication guideline header from “Chronic Hepatitis C” to “Chronic Hepatitis C Genotype 1” Sutent (Sunitinib) Revised  Revised coverage guidelines (refer to Sutent for complete details on applicable coverage criteria):

o Revised initial authorization criteria for treatment of lung neuroendocrine tumors (off-label); added criterion requiring one of

the following:

. Disease is stage IIIb (T4 due to multiple lung nodules)

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Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Sutent (Sunitinib) Revised . Disease is stage IV low-grade Guidelines (continued) . Disease is stage IV intermediate grade (continued) o Revised initial authorization criteria for treatment of chordoma (off- label); replaced criterion requiring “diagnosis of chordoma” with “diagnosis of recurrent chordoma” o Added coverage criteria for treatment of central nervous system cancer (off-label) to indicate: . Initial authorization will be approved (for 12 months) based on all of the following criteria: - Diagnosis of surgically inaccessible meningiomas; and - One of the following:  Disease is recurrent  Disease is progressive and - Further radiation is not possible . Reauthorization will be approved (for 12 months) based on the following criterion: - Patient does not show evidence of progressive disease while on Sutent therapy o Added coverage criteria for treatment of thymic carcinoma to indicate: . Initial authorization will be approved (for 12 months) based on the following criterion: - Diagnosis of thymic carcinoma . Reauthorization will be approved (for 12 months) based on the following criterion: - Patient does not show evidence of progressive disease while on Sutent therapy Synjardy (Empagliflozin/ New  Added coverage guidelines (precertification requirements apply); refer to Metformin Drug Coverage Criteria - New and Therapeutic Equivalent Medications for Hydrochloride) complete details on applicable coverage criteria

Tamoxifen Revised  Revised coverage guidelines (refer to Tamoxifen for complete details on

applicable coverage criteria):

o Updated coverage criteria for approval of copayment deduction;

removed criterion requiring member is female

Technivie (Ombitasvir/ New  Added coverage guidelines (precertification requirements apply); refer to

Paritaprevir/Ritonavir) the following policies for complete details on applicable coverage criteria:

o For CT and NY plan members: Technivie - CT/NY

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REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Technivie (Ombitasvir/ New o For NJ plan members: Technivie - NJ Guidelines Paritaprevir/Ritonavir) o For all states: Hepatitis C Direct Acting Antivirals (continued) (continued) Victrelis (Boceprevir) Updated  Revised coverage guidelines for Hepatitis C Direct Acting Antiviral criteria (refer to Hepatitis C Direct Acting Antivirals for complete details on applicable coverage criteria); o Updated coverage criteria; changed service/indication guideline header from “Chronic Hepatitis C” to “Chronic Hepatitis C Genotype 1” Viekira Pak (Ombitasvir, Revised  Revised coverage guidelines for NJ plan members (refer to Viekira Pak – Paritaprevir (ABT-450) NJ for complete details on applicable coverage criteria): and Ritonavir) o Revised documentation requirements for all applicable indications; . Removed scoring outcome requirement for:

- Liver biopsy

- Transient elastography (Fibroscan) - FibroTest (FibroSURE) score - APRI o Revised coverage criteria for treatment of chronic hepatitis C genotype 1a or mixed genotype 1 infection in patients without

cirrhosis and not post liver transplant and treatment of chronic

hepatitis C genotype 1b infection in patients without cirrhosis and not post liver transplant; removed criterion requiring:

. Documentation that the patient is taking immunosuppressant therapy for a non-hepatic (liver) organ transplant (e.g., heart,

kidney, lungs)

. Patient is co-infected with HIV o Revised coverage criteria for treatment of chronic hepatitis C genotype 1a or mixed genotype 1 infection in patients with cirrhosis and who are treatment naïve or treatment experienced with a prior relapse to interferon-based therapy and not post

liver transplant, treatment of chronic hepatitis C genotype 1a or mixed genotype 1 infection in patients with cirrhosis and who

are treatment experienced with a prior partial response or null response to interferon-based therapy and not post liver

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REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Viekira Pak (Ombitasvir, Revised transplant and treatment of chronic hepatitis C genotype 1b Guidelines Paritaprevir (ABT-450) infection in patients with cirrhosis and not post liver transplant: (continued) and Ritonavir) . Added criterion requiring submission of medical records (e.g., chart (continued) notes, laboratory values) documenting diagnosis of chronic hepatitis C genotype 1 infection with cirrhosis (i.e., Metavir score of F4) . Removed criterion requiring submission of medical records (e.g., chart notes, laboratory values) documenting stage 4 hepatic fibrosis  Revised coverage guidelines for Hepatitis C Direct Acting Antiviral (refer to Hepatitis C Direct Acting Antivirals for complete details on applicable coverage criteria): o Updated coverage criteria; changed service/indication guideline header from “Chronic Hepatitis C” to “Chronic Hepatitis C Genotype 1” Votrient (Pazopanib) Revised  Revised coverage guidelines (refer to Votrient for complete details on applicable coverage criteria): o Revised initial authorization criteria for treatment of soft tissue sarcoma (STS) to indicate approval will based on one of the following

criteria:

. Diagnosis of one of the following: - Angiosarcoma - Pleomorphic rhabdomyosarcoma - Retroperitoneal/Intra-abdominal of nonliposarcomal origin with disease that is unresectable or progressive - Soft Tissue Sarcoma of the Extremity/Superficial Trunk of

nonliposarcomal origin with disease that is synchronous stage IV or recurrent and has disseminated metastases

. Both of the following: - Diagnosis of progressive gastrointestinal stromal tumors (GIST); and - History of failure, contraindication, or intolerance to one of the

following:

 Gleevec (imatinib)

 Sutent (sunitinib)  Stivarga (regorafenib)

o Revised initial authorization criteria for treatment of thyroid carcinoma (off-label) to indicate approval will be based on one of the following criteria: . All of the following:

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Clinical Policy Updates

 Papillary carcinoma and

. One of the following:

- Unresectable recurrent disease - Persistent locoregional disease - Metastatic disease and

. One of the following:

- Patient has symptomatic disease

- Patient has progressive disease

and

. Disease is refractory to radioactive iodine treatment; or . All of the following:

- Diagnosis of medullary carcinoma; and

- One of the following:

 Disease is progressive

 Disease is symptomatic with distant metastases and . History of failure, contraindication, or intolerance to one of the following: - Caprelsa (vandetanib) - Cometriq (cabozantinib) o Added coverage criteria for treatment of dermatofibrosarcoma

protuberans (DFSP) (off-label) to indicate: . Initial authorization will be approved (for 12 months) based on the following criterion: - Diagnosis of metastatic dermatofibrosarcoma protuberans (DFSP) . Reauthorization will be approved (for 12 months) based on the following criterion: - Patient does not show evidence of progressive disease while on Votrient therapy

o Added coverage criteria for treatment of ovarian cancer (off-label) to indicate: . Initial authorization will be approved (for 12 months) based on all of the following criteria:

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REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Votrient (Pazopanib) Revised - Diagnosis of one of the following: Guidelines (continued)  Epithelial Ovarian Cancer (continued)  Fallopian Tube Cancer  Primary Peritoneal Cancer and - Disease is stage II-IV; and - Patient is in complete remission following primary treatment . Reauthorization will be approved (for 12 months) based on the criterion: - Patient does not show evidence of progressive disease while on Votrient therapy Zarxio (Filgrastim-Sndz) New  Added coverage guidelines (precertification requirements apply); refer to Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details on applicable coverage criteria Zecuity 6.5mg/4 Hr New  Added coverage guidelines (precertification requirements apply); refer to Patch (Sumatriptan Drug Coverage Criteria - New and Therapeutic Equivalent Medications for Iontophoretic) complete details on applicable coverage criteria

Zomacton (Somatropin) Revised  Revised coverage guidelines (refer to Zomacton for complete details on

applicable coverage criteria); added initial therapy and reauthorization

criteria for the following indications: o Pediatric Growth Hormone Deficiency (GHD)

o Prader-Willi Syndrome o Growth Failure in Children Small for Gestational Age (SGA) o Turner Syndrome or Noonan Syndrome

o Short-Stature Homeobox (SHOX) Gene Deficiency o Growth Failure associated with Chronic Renal Insufficiency o Adult Growth Hormone Deficiency o Transition Phase Adolescent Patients o Idiopathic Short Stature (for the state of Maryland only)

Zorbtive (Somatropin) Revised  Revised coverage guidelines (refer to Zorbtive (somatropin) for complete

details on applicable coverage criteria):

o Updated initial therapy and reauthorization criteria for treatment of

pediatric growth hormone deficiency (GHD), adult growth hormone

deficiency and transition phase adolescent patients:

. Removed/replaced criterion requiring GH is dosed according to FDA

approved labeling for growth hormone deficiency

. Added criterion indicating with coverage will be provided up to a

maximum supply limit of 0.3 mg/kg/week:

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Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Nov. 1, 2015 Zorbtive (Somatropin) Revised o Updated initial therapy and reauthorization criteria for the treatment of Guidelines (continued) idiopathic short stature for the state of Maryland only; added criterion (continued) indicating coverage will be provided up to a maximum supply limit of 0.3 mg/kg/week

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale High Frequency Nov. 1, 2015  Updated benefit considerations; High-frequency chest wall compression (HFCWC), as a form of chest Chest Wall added language to indicate: physical therapy, is proven and medically necessary when used for Compression o Some of the disorders for treating or preventing pulmonary complications of the following Devises which high frequency chest conditions: wall compression is unproven  Cystic fibrosis (CF) are serious, rare diseases  Bronchiectasis o Benefit coverage for an otherwise unproven service for High-frequency chest wall compression (HFCWC), as a form of chest the treatment of serious, rare physical therapy, is unproven and not medically necessary for diseases may occur when diagnoses other than cystic fibrosis and bronchiectasis, including, certain conditions are met but not limited to respiratory symptoms attributed to neuromuscular o The member-specific benefit disorders when they compromise respiration, such as amyotrophic document must be consulted lateral sclerosis (ALS), cerebral palsy, familial dysautonomia, to make coverage decisions in muscular dystrophy or quadriplegia. these circumstances  Revised coverage rationale; The clinical evidence is insufficient to support conclusions regarding the use added language to indicate there of HFCWC therapy in these patient populations. Additional research involving are multiple airway clearance larger study populations and longer treatment and follow-up periods is techniques currently used in the needed to establish the safety and efficacy of HFCWC for patients with management of CF and impaired airway clearance disorders in these patient populations. bronchiectasis; these can include percussion and postural drainage, Note: There are multiple airway clearance techniques currently used in the huffing, active cycle breathing management of CF and bronchiectasis. These can include percussion and and intrapulmonary percussive postural drainage, huffing, active cycle breathing and intrapulmonary ventilation (IPV) percussive ventilation (IPV).  Updated supporting information to reflect the most current clinical evidence and references

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Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Injectable Feb. 1, 2016* *Implementation Delayed: The Oxford has engaged CareCore National (CCN) to perform precertification Chemotherapy changes noted below will not be reviews for injectable chemotherapy drugs administrated in an outpatient Drugs: Application effective on Dec. 1, 2015 as setting to treat a cancer diagnosis. Oxford continues to be responsible for of NCCN Clinical previously announced. claims payment decisions and for appeals.

Practice Guidelines Implementation of the revised policy

has been postponed until Feb. 1, All precertification requests for injectable chemotherapy drugs are handled 2016. by CCN. To obtain precertification for injectable chemotherapy medications providers must contact CCN. Providers are encouraged to obtain  Added conditions of precertification on line by logging in to OxfordHealth.com and selecting the coverage/authorization link to the CCN authorization web site. Providers may also obtain requirements to indicate precertification by calling 866-889-8054. precertification is now required for

injectable chemotherapy drugs CCN uses the National Comprehensive Cancer Network’s (NCCN) guidelines through CareCore National in their decision making process. These guidelines provide independent  Updated benefit considerations: recommendations for evidence-based cancer treatment. The guidelines are o Removed language indicating continually updated to be consistent with the current treatment options. this policy does not apply to Providers and patients may access and view the NCCN guidelines at Members younger than 19 NCCN.org. years of age

o Added language pertaining to Oxford recognizes indications and uses of oncology medications listed in the NJ Small, NJ Individual, NJ NCCN Drugs and Biologics Compendium with Categories of Evidence and School Board and NJ Consensus of 1, 2A, and 2B as proven and medically necessary and Municipality products to Categories of Evidence and Consensus of 3 as unproven and not medically indicate: necessary. . Services indicated as

requiring a precertification Additional Information require medical necessity The NCCN Clinical Practice Guidelines in Oncology™ (NCCN Guidelines®) are review; this review may be a comprehensive set of guidelines documenting sequential management requested prior to service decisions and interventions that apply to malignancies which affect about . If a medical necessity 97% of all patients with cancer. They also address supportive care issues. review is not requested by The guidelines are developed and updated by 47 individual panels, composed the provider prior to of more than 950 clinicians and oncology researchers from the 25 NCCN service, the medical member institutions and their affiliates. necessity review will be

conducted after the service NCCN Categories of Evidence and Consensus is rendered with no penalty  Category 1: The recommendation is based on high-level evidence (i.e., imposed for failure to high-powered randomized clinical trials or meta-analyses), and the panel request the review prior to has reached uniform consensus that the recommendation is indicated. In rendering the service this context, uniform means near unanimous positive support with some

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Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Injectable Feb. 1, 2016* . It is the referring possible neutral positions. Chemotherapy physician’s responsibility to Drugs: Application provide medical  Category 2A: The recommendation is based on lower level evidence, of NCCN Clinical documentation to but despite the absence of higher level studies, there is uniform

Practice Guidelines demonstrate clinical consensus that the recommendation is appropriate. Lower level evidence

(continued) necessity for the study that is interpreted broadly, and runs the gamut from phase II to large cohort is being requested (for studies to case series to individual practitioner experience. Importantly, review prior to service) or in many instances, the retrospective studies are derived from clinical has been rendered (for experience of treating large numbers of patients at a member institution, review after service was so panel members have first-hand knowledge of the data. Inevitably, provided) some recommendations must address clinical situations for which limited  Revised coverage rationale: or no data exist. In these instances the congruence of experience-based

o Added language to indicate: opinions provides an informed if not confirmed direction for optimizing . Oxford has engaged patient care. These recommendations carry the implicit recognition that CareCore National (CCN) to they may be superseded as higher level evidence becomes available or perform precertification as outcomes-based information becomes more prevalent. reviews for injectable chemotherapy drugs  Category 2B: The recommendation is based on lower level evidence, administrated in an and there is nonuniform consensus that the recommendation should be outpatient setting to treat a made. In these instances, because the evidence is not conclusive,

cancer diagnosis; Oxford institutions take different approaches to the management of a particular continues to be responsible clinical scenario. This nonuniform consensus does not represent a major for claims payment disagreement rather it recognizes that given imperfect information, decisions and for appeals institutions may adopt different approaches. A Category 2B designation . All precertification requests should signal to the user that more than one approach can be inferred for injectable chemotherapy from the existing data. drugs are handled by CCN

- To obtain precertification  Category 3: The recommendation has engendered a major for injectable disagreement among the panel members. Several circumstances can

chemotherapy cause major disagreements. For example, if substantial data exists about medications providers two interventions but they have never been directly compared in a must contact CCN randomized trial, adherents to one set of data may not accept the - Providers are encouraged interpretation of the other side's results. Another situation resulting in a to obtain precertification Category 3 designation is when experts disagree about how trial data can on line by logging in to be generalized. A Category 3 designation alerts users to a major OxfordHealth.com and interpretation issue in the data and directs them to the manuscript for an

selecting the link to the explanation of the controversy. CCN authorization web site

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Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Injectable Feb. 1, 2016* - Providers may also If the drug regimen being requested does not have a NCCN 1, 2a, or 2b Chemotherapy obtain precertification by NCCN Guideline recommendation, refer to the following Oxford policies: Drugs: Application calling 866-889-8054  Clinical Trials of NCCN Clinical  Experimental/Investigational Treatment . CCN uses the National Practice Guidelines Comprehensive Cancer  Experimental/Investigational Treatment for NJ Plans

(continued) Network’s (NCCN) guidelines in their decision Facilities, physicians and other health care professionals are encouraged to making process utilize the most appropriate ICD-9-CM diagnosis codes in accordance with - These guidelines provide applicable code set guidelines. The use of a sole non-specific code, e.g., independent V58.11 (Encounter for antineoplastic chemotherapy), may result in the need recommendations for for Oxford to request additional clinical documentation prior to a evidence-based cancer determination of coverage and/or reimbursement.

treatment

- The guidelines are continually updated to be consistent with the current treatment options - Providers and patients may access and view the

NCCN guidelines at

NCCN.org o Removed language indicating: . 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

. While precertification is not required for injectable

chemotherapy drugs, Oxford will provide a pre- service clinical review and

78 Oxford® Policy Update Bulletin: October 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Injectable Feb. 1, 2016* coverage determination Chemotherapy upon request Drugs: Application . In the absence of of NCCN Clinical precertification for

Practice Guidelines injectable chemotherapy

(continued) drugs, Oxford will perform a post-service retrospective review upon claim submission; medical necessity is determined via the guidelines described in this policy, and may be reviewed in conjunction with one or more of the following Oxford policies . Chemotherapy drugs used in the treatment of diagnoses listed on the Exceptions to Cancer Diagnosis Codes List are not subject to clinical review and will be reimbursed in accordance with a Member's health benefits plan  Added a “description of services” addressed in the policy Panniculectomy Nov. 1, 2015  Revised coverage Panniculectomy and Body rationale/requirements for Panniculectomy is considered reconstructive and medically Contouring coverage for panniculectomy: necessary when the following criteria are present: Procedures o Updated coverage criteria for a. Panniculus must hang below symphysis pubis; and reconstructive/medically b. The panniculus is the primary cause of skin conditions when present, necessary surgery: such a cellulitis requiring systemic antibiotics or transdermal skin . Removed criterion requiring ulcerations that require medical treatment. “the panniculus causes a c. There is presence of a functional impairment due to the panniculus; chronic and persistent skin d. The surgery is expected to restore or improve the functional impairment; condition (e.g., e. The panniculus is interfering with activities of daily living. intertriginous dermatitis, Note: cellulitis or transdermal skin o After significant weight loss not following bariatric surgery, in

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REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Panniculectomy Nov. 1, 2015 ulcerations) that is addition to the criteria listed above, there must be documentation and Body refractory to at least three that a stable weight has been maintained for six months. Contouring months of medical o After significant weight loss following bariatric surgery, in addition to Procedures treatment and associated meeting the criteria listed above there must be documentation that a (continued) with at least one episode of stable weight has been maintained for six months. This often occurs cellulitis requiring systemic 12-18 months after surgery. antibiotics; in addition to good hygiene practices, Panniculectomy is not considered reconstructive and not medically treatment should include necessary, and is not a covered service, in the following situations topical antifungals, topical (not an all-inclusive list): and/or systemic 1. When performed to relieve neck or back pain as there is no evidence that corticosteroids, and/or local reduction of redundant skin and tissue results in less spinal stress or or systemic antibiotics improved posture/alignment. . Added criterion requiring 2. When performed in conjunction with abdominal or gynecologic surgery “the panniculus is the including but not limited to hernia repair, obesity surgery, C-section and primary cause of skin hysterectomy unless the enrollee meets the criteria for panniculectomy conditions when present, as stated above in this document. such a cellulitis requiring 3. Performed post childbirth in order to return to pre pregnancy shape. systemic antibiotics or 4. Performed for intertrigo, a superficial inflammatory response or any other transdermal skin ulcerations condition that does not meet the criteria above in this document. that require medical treatment” Documentation may be requested as part of the review, including but not . Updated notation language limited to photographs and physician office notes. to indicate: Abdominoplasty - After significant weight loss not following Abdominoplasty is not considered reconstructive or medically bariatric surgery, in necessary, and is not a covered service, in the following situations addition to the listed (not an all-inclusive list): criteria, there must be 1. Performed post childbirth in order to return to pre-pregnancy shape documentation that a 2. Performed for diastasis recti stable weight has been 3. When performed in conjunction with abdominal or gynecologic surgery maintained for six including but not limited to hernia repair, obesity surgery, C-section and months hysterectomy - After significant weight 4. No documentation of a physical and/or physiological impairment loss following bariatric Lipectomy surgery, in addition to meeting the listed Lipectomy is not considered reconstructive or medically necessary, criteria, there must be and is not a covered service in the following situation (not an all (not documentation that a an all-inclusive list):

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REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Panniculectomy Nov. 1, 2015 stable weight has been 1. Performed on any site including buttocks, arms, legs, neck, abdomen and and Body maintained for six medial thigh Contouring months; this often Suction Assisted Lipectomy of the Trunk Procedures occurs 12-18 months (continued) after surgery Suction Assisted Lipectomy of the Trunk (CPT code 15877) is not - Added language to considered reconstructive (unless part of an approved procedure) or indicate documentation medically necessary, and is not a covered service. For post- may be requested as mastectomy patients, please refer to the policy titled Breast Reconstruction part of the clinical Post Mastectomy. review, including but not limited to photographs and physician office notes Plagiocephaly and Nov. 1, 2015  Updated and reorganized benefit Cranial orthotic devices are reconstructive and medically necessary Craniosynostosis considerations: for: Treatment o Removed/replaced language a) Craniosynostosis (i.e., synostotic plagiocephaly) following indicating: surgical correction . Refer to Member’s certificate b) treatment of craniofacial asymmetry in infants 3-18 months of of coverage/benefit plan age with severe nonsynostotic positional plagiocephaly when all document for coverage the following criteria are present (1, 2 and 3): information 1. Infant is 18 months of age or younger . Some states require benefit 2. Severe asymmetry is present with or without torticollis coverage for cranial orthotic 3. There is documentation of a trial of conservative therapy of at least 2 devices and/or for treatment months duration with cranial repositioning, with or without stretching of congenital conditions that therapy might otherwise be considered cosmetic Severe plagiocephaly is defined as an asymmetry of 10 mm or more in one . State mandates for of the following anthropometric measures: cranial vault, skull base, or coverage and the Member orbitotragial depth; OR a cephalic index at least two standard deviations specific benefit document above or below the mean for the appropriate gender/age. Clinical evidence must be used to decide demonstrates improved surgical outcomes with the post-operative use of the coverage orthotic device. . A cranial helmet is considered an orthotic when Note: Please see the Description of Services section of this policy for used for the non-surgical additional information regarding Anthropometric measurements and Cephalic treatment of plagiocephaly Index graph. Please see related policies link above for detailed information . Cranial helmets used to related to repair and replacements of cranial orthotic devices facilitate a successful post-

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Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Plagiocephaly and Nov. 1, 2015 surgical outcome are a Cranial orthotic devices are cosmetic and not medically necessary in Craniosynostosis covered health service infants with mild to moderate plagiocephaly. Treatment o Added language to indicate: (continued) . When deciding coverage for There are no definitive data demonstrating that there are adverse health this service, the member- effects associated with a mild to moderate degree of cranial asymmetry, and, specific benefit document therefore, it is unclear whether treatment of these individuals provides a language must be future health benefit, or merely a cosmetic effect. In general, severe referenced plagiocephaly occurs in utero and is present at birth. Limited clinical evidence . Most Certificates of suggests that it may be associated with future ocular and/or oral Coverage (COCs) and some abnormalities. Acquired plagiocephaly occurs following the placement of the Summary Plan Descriptions infant in a supine sleeping position to prevent sudden infant death syndrome, (SPDs) contain an explicit and is ordinarily mild to moderate. Positional plagiocephaly has not been exclusion from coverage for linked to future comorbidities. orthotic devices . Some states require benefit Surgical treatment to repair craniosynostosis is reconstructive and coverage for cranial orthotic medically necessary irrespective of the approach used. devices and/or for treatment of congenital conditions that Less invasive procedures including endoscopic strip craniectomy and might otherwise be spring-mediated cranioplasty are proven and medically necessary as considered cosmetic a form of surgical treatment to repair craniosynostosis. . State mandates for coverage and the member- specific benefit document must be used to decide coverage . For the purpose of administration of the orthotic exclusion described above, a cranial helmet is considered an orthotic when used for the non-surgical treatment of plagiocephaly . Cranial helmets used to facilitate a successful post- surgical outcome are a covered health service.  Revised coverage rationale: o Replaced reference to “craniosynostosis” with

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Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Plagiocephaly and Nov. 1, 2015 “craniosynostosis (i.e., Craniosynostosis synostotic plagiocephaly)” Treatment o Updated coverage criteria for (continued) treatment of craniofacial asymmetry in infants 3-18 months of age with severe nonsynostotic positional plagiocephaly: . Removed criterion requiring lack of substantial improvement following conservative therapy of at least 2 months duration with cranial repositioning and stretching therapy . Added criterion requiring documentation of a trial of conservative therapy of at least 2 months duration with cranial repositioning, with or without stretching therapy o Added instruction to refer to the related policies titled Cosmetic and Reconstructive Procedures and DME, Orthotics, Ostomy Supplies, Medical Supplies, and Repairs/Replacements for information related to repair and replacement of cranial orthotic devices o Changed coverage status for less invasive procedures including endoscopic strip craniectomy and spring- mediated cranioplasty as a form of surgical treatment to repair craniosynostosis from “proven non-preferentially and

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Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Plagiocephaly and Nov. 1, 2015 medically necessary” to Craniosynostosis “proven and medically Treatment necessary” (continued)  Updated list of applicable HCPCS codes; removed A8000-A8003  Removed “Additional Products” information listing specific cranial orthotic device names and manufacturers  Updated supporting information to reflect the most current description of services, clinical evidence and references

REPLACED Policy Title Effective Date Summary of Changes Actimmune Nov. 1, 2015  Policy replaced; refer to policy titled Drug Coverage Guidelines for applicable coverage guidelines (Interferon Gamma-1b) Follicle Stimulating Nov. 1, 2015  Policy replaced; refer to the policy titled Follicle Stimulating Hormone (FSH) Gonadotropins for applicable Hormones (FSH) coverage guidelines Used in the Treatment of Infertility Human Menopausal Nov. 1, 2015  Policy replaced; refer to the policy titled Human Menopausal Gonadotropins (hMG) for applicable coverage Gonadotropins guidelines (hMG) Used in the Treatment of Infertility

84 Oxford® Policy Update Bulletin: October 2015 Oxford

Administrative Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Administrative Guidelines Orthopedic Oct. 1, 2015  Changed policy type classification Oxford covers medically necessary acute care services and post-acute Services from “Clinical” to “Administrative” services delivered at the most appropriate level of care. OrthoNet's (no change in content/guidelines) orthopedic division will perform utilization management to review requested  Updated lists of applicable codes; services that should meet approved clinical guidelines for medical necessity. added language to indicate ICD- Review is conducted by determining medical necessity and medical 10-CM (diagnoses) and ICD-10- appropriateness, and to initiate discharge planning as appropriate. The PCS (inpatient procedures) must review will be based on the obtained clinical information and some or all of be used to report services the following criteria/tools: provided on or after 10/01/2015:  Member benefits o ICD-9 codes will not be  Oxford medical and reimbursement policies accepted for services provided  MCG™ Care Guidelines, 19th edition, 2015 (Inpatient Care) on or after 10/01/2015 o ICD-10 codes will not be Services performed by the following specialists (participating/non- accepted for services provided participating), regardless of diagnosis, are subject to utilization review with prior to 10/01/2015 OrthoNet’s orthopedic division.  Hand Surgeon  Neurosurgeon  Orthopedic Surgeon  Pediatric Orthopedic Surgeon  Physical Medicine and Rehabilitation  Podiatrist

and

Services rendered by the below facilities (participating/non-participating), when billed in conjunction with certain identified ICD-9 codes (see the Applicable Codes section of this policy for a list of ICD-9 codes) are subject to utilization review with OrthoNet’s orthopedic division.  Acute Care Hospital  Ambulatory Surgery Center  Durable Medical Equipment  Home Health Care  Physical Rehabilitation Hospital  Physical Rehabilitation Facility  Skilled Nursing Facility  Other Ancillary

Medical Director Review Requirements

If a request is submitted which:

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Administrative Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Administrative Guidelines Orthopedic Oct. 1, 2015  Meets the applicable guideline(s)/medical criteria, an Orthonet Services Case Manager may make a utilization review decision (with oversight by (continued) a Medical Director).  Does not meet the applicable guideline(s)/criteria, and/or there is a question regarding whether the request is a covered benefit, the request will be referred to an OrthoNet Medical Director for review and decision-making.

Additional information as well as input from a consultant may be requested and reviewed as part of this process.

In the case of non-certification decisions, where the Orthonet Case Manager did not make an attempt to discuss the matter with the Member’s provider, a reconsideration procedure will be offered and activated according to current regulatory requirements and Oxford policy.

A Medical Director must make all adverse utilization review decisions including those for benefit non-certifications (with the exception of non- certification due to the member's enrollment status with Oxford and approval determinations).

Note:  Home health and skilled nursing facility (SNF) benefits will be coordinated between Oxford and OrthoNet Global Orthopedics.  Pre-Existing Conditions: Individuals of any age cannot be denied coverage, charged higher premiums, subjected to an extended waiting period or have benefits modified because of a preexisting condition. Refer to the Preexisting Conditions policy for additional information.  Payment for requested services will be based on Oxford medical and reimbursement policies.

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Accreditation Oct. 1, 2015  Revised administrative This policy is only applicable to Radiologists and Radiology centers. Requirements for guidelines; removed credentialing  For diagnostic imaging performed by primary care physicians, specialty Radiologists and requirement for hospitals physicians and other health care professionals in office settings, refer to Radiology Centers performing Coronary CT the Oxford's Outpatient Imaging Self-Referral Policy for accreditation and Angiography (CCTA) certification requirements.

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Accreditation Oct. 1, 2015  This policy is not applicable to radiology services performed during an Requirements for inpatient stay, ambulatory surgery, emergency room visit, or pre- Radiologists and operative/pre-admission testing. Radiology Centers  All X-rays performed at an urgent care facility are payable. (continued)  Some Radiology and Cardiology procedures require precertification. Refer to the following policies for additional information: o Radiology Procedures: . Radiology Procedures Requiring Precertification for eviCore Healthcare Arrangement o Cardiology Procedures: . Cardiology Procedures Requiring Precertification for eviCore Healthcare Arrangement Or contact eviCore via one of the two options listed below: o Providers can call eviCore at 1-877-PreAuth (773-2884); or o Providers can log onto www.evicore.com Credentialing Oct. 1, 2015  Revised administrative Oxford has engaged eviCore Healthcare to perform Credentialing as well as Guidelines: guidelines; removed credentialing Quality and Equipment review of Outpatient Diagnostic Radiology Centers Participation in the requirement for hospitals who participate or wish to participate in the Oxford network. eviCore Healthcare performing Coronary CT Network Angiography (CCTA) The minimum standards for consideration into the Oxford network can be found at eviCore.com > Practice Assessments/Standards.

Radiologists and radiology centers in New York (NY) and New Jersey (NJ) who are interested in participating in the Oxford network radiologists and radiology centers that already participate in the Oxford network and want to add a modality to their practice are required to complete the Professional Physician Practice Assessment (PPPA) from eviCore Healthcare.  Exception: Radiologists and radiology centers performing outpatient radiology imaging studies in Connecticut (CT) are excluded from the above credentialing requirements.

All radiologists, radiology centers, and cardiologists NY, NJ and CT who are currently participating in the Oxford network or wish to participate in the Oxford network and perform CCTA, are required to fill out the Coronary CT Angiography & Cardiac CT Professional Physician Practice Assessment (CT- PPPA) from eviCore Healthcare.

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Credentialing Oct. 1, 2015 PPPA and CT-PPPA documents can be obtained on eviCore Healthcare’s Guidelines: website at eviCore.com > Practice Assessments/Standards and eviCore.com Participation in the > Cardiology > Cardiac CT Specialty Center. eviCore Healthcare Network The PPPA can also completed by visiting eviCore Healthcare’s website at (continued) eviCore.com> Professional Physician/Practice Assessment.

Timeframe Nov. 1, 2015  Revised guidelines for Notice of Refer to the policy for complete details on Timeframe Standards for Standards for an Adverse Benefit Determination Utilization Management (UM) Initial Decisions. Utilization for Connecticut plans; updated Management (UM) requirements pertaining to Initial Decisions clinical peer consultation to indicate: o A health carrier is required to offer a covered person's health care professional the opportunity to confer with a clinical peer, as long as a grievance has not already been filed prior to the conference o The health carrier is required to notify the covered person's health care professional that this conference between the physician and the health care professional peer is not considered a grievance of the initial adverse determination as long as a grievance has not been filed Transportation Nov. 1, 2015  Added reference link to policy Note: Refer to the Ambulance Policy for additional information regarding the Services titled Ambulance Policy reimbursement of ambulance transportation services.  Updated and reformatted I. Emergency Transportation conditions of coverage/special A. Land Transportation: Coverage includes emergency ambulance considerations; removed transportation by a licensed ambulance service from the location of duplicative language the sudden illness or injury, to the nearest hospital where services  Updated benefit considerations: can be performed.

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Transportation Nov. 1, 2015 o Added language to indicate: Emergency transportation to an acute care hospital and/or hospital Services . Before using this guideline, emergency facility does not require notification, pre-certification or (continued) please check member certification. specific benefit document B. Air Transportation: Precertification with review by a Medical and any federal or state Director or their designee is required for all air transportation. In mandates, if applicable the event precertification is not feasible due to time constraints . If there is a difference related to medical emergencies, Oxford will require review of clinical between the policy and the notes post service and prior to payment. Member’s plan of benefits or Certificate of Coverage, As a general guideline, when it would take a ground ambulance 30- the plan of benefits or 60 minutes or more to transport an member whose medical Certificate of Coverage will condition at the time of pick-up required immediate and rapid govern transport due to the nature and/or severity of the member’s . For Essential Health illness/injury, air transportation may be appropriate. Benefits for Individual and Small Group plans: Air ambulance transportation should meet the following criteria: - For plan years beginning 1. The patient’s destination is an acute care hospital, and on or after January 1, 2. The patient’s condition is such that the ground ambulance (basic 2014, the Affordable or advanced life support) would endanger the Member’s life or Care Act of 2010 (ACA) health, or requires fully insured 3. Inaccessibility to ground ambulance transport or extended length non-grandfathered of time required to transport the patient via ground ambulance individual and small transportation could endanger the Member, or group plans (inside and 4. Weather or traffic conditions make ground ambulance outside of Exchanges) to transportation impractical, impossible, or overly time consuming. provide coverage for ten categories of Essential II. Non-emergency Transportation: Coverage includes non-Emergency Health Benefits (“EHBs”) ambulance transportation by a licensed ambulance service (either - Large group plans (both ground or air ambulance), between health care facilities when the self-funded and fully ambulance transportation is any of the following: insured), and small 1. From a non-network hospital to a network hospital group ASO plans, are 2. To a hospital that provides a required higher level of care that was not subject to the not available at the original hospital requirement to offer 3. To a more cost-effective acute care facility coverage for EHBs; 4. From an acute facility to a sub-acute setting however, if such plans choose to provide Precertification with review by a Medical Director or their designee is coverage for benefits required for all non-emergent transportation and is covered only when which are deemed EHBs

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Transportation Nov. 1, 2015 (such as maternity the member’s specific benefit document includes coverage for non- Services benefits), the ACA emergent ambulance/transportation and/or coverage is required due to (continued) requires all dollar limits federal or state mandates. on those benefits to be removed on all III. Out of Country Transportation: When a member has traveled outside Grandfathered and Non- of the United States, Mexico, Canada and the U.S. Territories, Grandfathered plans emergency transportation to the nearest hospital and/or hospital - The determination of emergency facility does not require notification, pre-certification or which benefits constitute certification. However, Oxford should be notified of an admission within EHBs is made on a state 48 hours or as soon as possible, consistent with the Member's by state basis; as such, certificate. when using this guideline, it is important All requests for any other out of the country transportation, including to refer to the member repatriation, require precertification and Medical Director review. specific benefit document to determine Refer to Members Outside of the United States for additional information benefit coverage on coverage for services received outside of the United States, Mexico, o Removed language pertaining Canada and the U.S. Territories. to coverage limitations and exclusions o Removed product specific information for Healthy NY plans  Reorganized and revised coverage rationale: o Added notation to refer to the Ambulance Policy for additional information regarding the reimbursement of ambulance transportation services o Revised coverage guidelines/ criteria for Emergency Transportation to indicate:

Land Transportation . Coverage includes emergency ambulance

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Transportation Nov. 1, 2015 transportation by a licensed Services ambulance service from the (continued) location of the sudden illness or injury, to the nearest hospital where services can be performed . Emergency transportation to an acute care hospital and/or hospital emergency facility does not require notification, precertification or certification Air Transportation . Precertification with review by a Medical Director or their designee is required for all air transportation; in the event precertification is not feasible due to time constraints related to medical emergencies, Oxford will require review of clinical notes post service and prior to payment . As a general guideline, when it would take a ground ambulance 30-60 minutes or more to transport an member whose medical condition at the time of pick-up required immediate and rapid transport due to the nature and/or severity of the member’s illness/injury, air transportation may be

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Transportation Nov. 1, 2015 appropriate Services . Air ambulance (continued) transportation should meet the following criteria: 1. The patient’s destination is an acute care hospital, and 2. The patient’s condition is such that the ground ambulance (basic or advanced life support) would endanger the Member’s life or health, or 3. Inaccessibility to ground ambulance transport or extended length of time required to transport the patient via ground ambulance transportation could endanger the Member, or 4. Weather or traffic conditions make ground ambulance transportation impractical, impossible, or overly time consuming o Revised coverage guidelines/criteria for Non- Emergency Transportation to indicate: . Coverage includes non- emergency ambulance transportation by a licensed ambulance service (either ground or air ambulance),

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Transportation Nov. 1, 2015 between health care Services facilities when the (continued) ambulance transportation is any of the following: 1. From a non-network hospital to a network hospital 2. To a hospital that provides a required higher level of care that was not available at the original hospital 3. To a more cost-effective acute care facility 4. From an acute facility to a sub-acute setting . Precertification with review by a Medical Director or their designee is required for all non-emergent transportation and is covered only when the member specific benefit document includes coverage for non-emergent ambulance/transportation and/or coverage is required due to federal or state mandates o Revised coverage guidelines/ criteria for Emergency Transportation to indicate: Out of Country Transportation . When a member has traveled outside of the United States, Mexico, Canada and the U.S.

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Transportation Nov. 1, 2015 Territories, emergency Services transportation to the (continued) nearest hospital and/or hospital emergency facility does not require notification, precertification or certification; however, Oxford should be notified of an admission within 48 hours or as soon as possible, consistent with the Member's certificate . All requests for any other out of the country transportation, including repatriation, require precertification and Medical Director review . Refer to the policy titled Members Outside of the United States for additional information on coverage for services received outside of the United States, Mexico, Canada and the U.S. Territories o Removed guidelines/criteria pertaining to: . Documentation requirements . Transportation vehicle and crew requirements . Transportation destinations . Paramedic intercept services  Revised definitions; removed definition of “ambulette” and “rural area”  Reformatted and revised lists of

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Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Transportation Nov. 1, 2015 applicable HCPCS codes: Services o Reorganized codes by service (continued) type: Air Ambulance and Ground/Other Ambulance o Updated list of applicable air ambulance codes: . Added S9960, S9961 and T2007 . Updated description for A0430 and A0431 o Updated list of applicable ground/other ambulance codes; added A0382, A0384, A0392, A0394, A0396, A0398, A0420, A0999, S0207 and S0208 o Removed list of non-covered HCPCS codes

95 Oxford® Policy Update Bulletin: October 2015 Oxford

Reimbursement Policy Updates

\ UPDATED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Oct. 19, 2015  Revised MFD Code Policy List MFD Determination: Part I Frequency Per Day (attachment file): The following criteria are first used to determine the MFD values for codes to o Added maximum frequency which these criteria are applicable: per day value assignment for  The service is classified as bilateral (CMS Indicators 1 or 3) on the Q9979 Centers for Medicare & Medicaid Services (CMS) National Physician Fee o Updated maximum frequency Schedule (NPFS) or the term 'bilateral' is included in the code descriptor. per day value assignments for For the majority of these codes, the MFD value is 1. There are some 26010, 26070, 26357, 26358, codes that describe more than one anatomical site or vertebral level that 26370, 26373, 26390, 26392, can be treated bilaterally where the MFD value may be more than 1. 26437, 26450, 26480, 26483,  Where the CPT or HCPCS code description/verbiage references reporting 26485, 26489, 26490, 26492, the code once per day, the MFD value is 1. 26500, 26502, 26567, 26600,  The service is anatomically or clinically limited with regard to the number 26605, 26607, 26608, 26615, of times it may be performed, in which case the MFD value is established 26670, 26675, 26676, 26685, at that value. 26686, 26861, 26863, 28020,  The CPT or HCPCS code description/verbiage indicates the number of 28022, 28050, 28140, 28200, times the service can be performed, in which case the MFD value is set 28208, 28232, 28234, 28288, at that value. 28308, 28345, 28470, 28475,  CMS Durable Medical Equipment Medicare Administrative Contractor 28476, 28485, 28606, 28615, (DMEMAC) Local Coverage Determination (LCD) assigns an MFD value in 28740, 32554, 32555, 32556, which case the MFD value is set at that value. 32557, 35216, 35458, 82010,  Where the criteria above have not defined an MFD value, the CMS 82024, 82106, 82127, 82131, Medically Unlikely Edits (MUE) value, where available, will be utilized to 82136, 82139, 82150, 82190, establish an MFD value. 82308, 82355, 82360, 82365, 82370, 82397, 82487, 82530,  Where no other definitive value has been established based on the 82533, 82541, 82664, 82810, criteria above, drug HCPCS codes will have an MFD value of 999 which 82938, 82945, 82947, 83018, indicates they are exempt from the MFD policy. 83516, 83518, 83520, 83661,  Where no other definitive value has been established based on the 83663, 83883, 84100, 84132, criteria above, unlisted CPT and HCPCS codes will have an MFD value of 84157, 84181, 84182, 84233, 999 which indicates they are exempt from the MFD policy. 84234, 84244, 84315, 85004,  Where no other definitive value has been established based on the 85013, 85032, 85041, 85397, criteria above, new CPT codes released by the American Medical 85520, 85576, 85610, 85730, Association and new HCPCS codes released by CMS since the last MFD 86000, 86161, 86185, 86235, value update (not covered by any of the above criteria), will have an 86255, 86316, 86318, 86329, MFD value of 100. 86331, 86353, 86356, 86609, 86611, 86615, 86622, 86625, MFD Determination: Part II 86631, 86635, 86638, 86658, When none of the criteria listed in Part I apply to a code, data analysis is 86666, 86671, 86682, 86687, conducted to establish MFD values according to common billing patterns.

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Reimbursement Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Oct. 19, 2015 86688, 86701, 86710, 86717,  When a code has 50 or more claim occurrences in a data set, the MFD Frequency Per Day 86735, 86757, 86765, 86784, values are determined through claim data analysis and are set at the (continued) 86790, 86805, 86826, 86870, 100th percentile (i.e. the highest number of units billed for that CPT or 86885, 86902, 86905, 86920, HCPCS code in the data set). If the 100th percentile exceeds the 98th 86922, 86923, 86931, 86945, percentile by a factor of four, the MFD will be set at the 98th percentile. 86971, 86972, 86975, 86976,  When a code has less than 50 claim occurrences in a data set, the MFD 86977, 87324, 87328, 87329, values will be set at the default of 100 until the next annual analysis. 87385, 87491, 87493, 87497,  In any case where, in Oxford's judgment, the 98th percentile does not 87529, 87530, 87551, 87591, account for the clinical circumstances of the services billed, the MFD for 87904, 88104, 88106, 88108, a code may be increased so as to capture only obvious billing submission 88112, 88172, 88173, 88184, and data entry errors. 88187, 88188, 88189, A4233, A4398, A4459, A4633, A6531, The "MFD per Day Policy List" list below contains the most current MFD A6532, A7003, A7006, A7028, values. A7029, A7037, B4083, B4164, B4189, B4199, B5200, E1028  Maximum Frequency per Day Policy List and K0605 Reimbursement  Revised Codes Restricting Modifiers LT and RT (attachment The MFD values apply whether a physician or other health care professional file detailing codes that allow up submits one CPT or HCPCS code with multiple units on a single claim line or to the MFD limit that have multiple claim lines with one or more unit(s) on each line. It is common “bilateral” or “unilateral or coding practice for some CPT and HCPCS codes to be submitted with multiple bilateral” in the description or units. However, when reporting the same CPT or HCPCS code on multiple where the concept of laterality and/or separate claim lines, the claim line may be classified as a duplicate does not apply); added Q9979 service and/or may be subject to additional Oxford reimbursement policies.

Services provided are reimbursable services up to and including the MFD value for an individual CPT or HCPCS code. In some instances, a modifier may be necessary for correct coding and corresponding reimbursement purposes.

Bilateral payment via the use of modifiers LT or RT is inappropriate for procedures, services, and supplies where the concept of laterality does not apply. Oxford will pay up to the maximum frequency per day value for codes with "bilateral" or "unilateral or bilateral" in description or for codes where the concept of laterality does not apply, whether submitted with or without modifiers LT and/or RT by the same individual physician or other healthcare professional on the same date of service for the same member. Use of modifiers LT and/or RT on the codes identified in the "Codes Restricting

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Reimbursement Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Oct. 19, 2015 Modifiers LT and RT" list will be considered informational only. Frequency Per Day (continued)  Codes Restricting Modifiers LT and RT There may be situations where a physician or other healthcare professional reports units accurately and those units exceed the established MFD value. In such cases, Oxford will consider additional reimbursement if reported with an appropriate modifier such as modifier 59, 76, 91, XE, XS or XU. Medical records are not required to be submitted with the claim when modifiers 59, 76, 91, XE, XS or XU are appropriately reported. Documentation within the medical record should reflect the number of units being reported and should support the use of the modifier.

Modifiers

Modifier Modifier Description Distinct Procedural Service Under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-E/M services performed on the same day. Modifier 59 is used to identify procedures or services, other than E/M services, that are not normally reported together but are appropriate under the circumstances. Documentation must support a different session, different procedure or surgery, different size or organ system, separate incision or excision, 59 separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. However, when another already established modifier is appropriate it should be used rather than modifier 59. Only if no more descriptive modifier is available and the use of modifier 59 best explains the circumstances should modifier 59 be used. Note: Modifier 59 should not be appended to an E/M service. To report a separate and distinct E/M service performed on the same date, see modifier 25.

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UPDATED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Oct. 19, 2015 Repeat Procedure or Service by Same Physician or Other Frequency Per Day Qualified Health Care Professional (continued) It may be necessary to indicate that a procedure or service was repeated subsequent to the original procedure or service. This circumstance may be reported by adding modifier 76 to the repeated procedure or service. Note: This modifier should not be appended to an E/M service. 76 To report a separate and distinct E/M service performed on the same date, see modifier 25. It is also inappropriate to use modifier 76 to indicate repeat laboratory services. Modifiers 59 or 91 should be used to indicate repeat or distinct laboratory services, as appropriate according to the AMA and CMS. Separate consideration for reimbursement will not be given to laboratory codes reported with modifier 76. Repeat Clinical Diagnostic Laboratory Test In the course of treatment of the patient, it may be necessary to repeat the same laboratory test on the same day to obtain subsequent (multiple) test results. Under these circumstances, the laboratory test performed can be identified by its usual procedure number and the addition of modifier 91. Note: This modifier may not be used when tests are rerun to confirm initial 91 results; due to testing problems with specimens or equipment; or for any other reason when a normal, one-time, reportable result is all that is required. This modifier may not be used when other code(s) describe a series of test results (eg, glucose tolerance tests, evocative/suppression testing). This modifier may only be used for laboratory test(s) performed more than once on the same day on the same patient. Separate Encounter XE A service that is distinct because it occurred during a separate encounter. Separate Structure XS A service that is distinct because it was performed on a separate organ/structure. Unusual Non-Overlapping Service XU The use of a service that is distinct because it does not overlap usual components of the main service.

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UPDATED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Oct. 19, 2015 Anatomic Modifiers Frequency Per Day (continued) Modifier Modifier Description E1 Upper left eyelid E2 Lower left eyelid E3 Upper right eyelid E4 Lower right eyelid F1 Left hand, second digit F2 Left hand, third digit F3 Left hand, fourth digit F4 Left hand, fifth digit F5 Right hand, thumb F6 Right hand, second digit F7 Right hand, third digit F8 Right hand, fourth digit F9 Right hand, fifth digit FA Left hand, thumb LC Left circumflex coronary artery LD Left anterior descending coronary artery LM Left main coronary artery LT Left side RC Right coronary artery RI Ramus intermedius coronary artery RT Right side T1 Left foot, second digit T2 Left foot, third digit T3 Left foot, fourth digit T4 Left foot, fifth digit T5 Right foot, great toe T6 Right foot, second digit T7 Right foot, third digit T8 Right foot, fourth digit T9 Right foot, fifth digit TA Left foot, great toe

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Reimbursement Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Reduced Services Oct. 1, 2015  Routine review; no change to There are no industry standards for reimbursement of claims billed with reimbursement guidelines modifier 52 from the Centers for Medicare and Medicaid Services (CMS) or other professional organizations. Oxford's standard for reimbursement of modifier 52 is 50% of the Allowable Amount for the unmodified procedure.

This modifier is not used to report the elective cancellation of a procedure before anesthesia induction, intravenous (IV) conscious sedation, and/or surgical preparation in the operating suite.

Modifier 52 should not be used with an evaluation and management (E/M) service.

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Ambulance Policy Nov. 1, 2015  Revised Ambulance Bundled Code Ambulance Providers and Suppliers List (attachment file listing codes that are not separately Oxford considers only an Ambulance Provider or Supplier as eligible for reimbursed when reported with reimbursement of ambulance services reported with Healthcare Common an ambulance transportation Procedure Coding System (HCPCS) codes A0021 – A0999. code); added Q9979 Other provider specialties, e.g., emergency room physicians, should report the Current Procedural Terminology (CPT®) and/or HCPCS codes that specifically and accurately describe the services and procedures outside of the HCPCS code A0021-A0999 range.

Oxford will not reimburse non-ambulance providers or suppliers for rendering ambulance services.

Refer to the policy titled Ambulance Services Code List.

Origin and Destination Modifiers

For ambulance transportation claims, Oxford has adopted the Centers for

Medicare and Medicaid Services (CMS) guidelines that require an Ambulance

Provider or Supplier to report an origin and destination modifier for each trip

provided.

Each ambulance modifier is comprised of a single digit alpha character

identifying the origin of the transport in the first position, and a single digit

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REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Ambulance Policy Nov. 1, 2015 alpha character identifying the destination of the transport in the second (continued) position. Example: RH (residence to hospital).

In alignment with CMS, Oxford will reimburse a code on the Ambulance Transportation Codes list only when reported with a two-digit ambulance modifier on the Ambulance Modifiers list. Ambulance transportation services reported without a valid two-digit ambulance modifier will be denied.

When “X” (Intermediate stop at physician's office en route to the hospital) is present within the 2 digit modifier combination, “X” must be in the second digit position preceded by a valid origin digit in the first position. If “X” is the first digit of the two digit modifier combination, the ambulance transportation code will be denied.

 Ambulance Transportation Code List  Ambulance Modifiers List

Services Included in Ambulance Transportation

Per CMS, services including, but not limited to oxygen, drugs, extra attendants, supplies, EKG, and night differential are not paid separately when reported as part of an ambulance transportation service.

In alignment with CMS, Oxford will not reimburse codes on the Ambulance Bundled Codes list when provided by the Same Ambulance Provider or Supplier for the same patient on the same date of service as a code on the Ambulance Transportation Codes list. This applies to network providers only.

 Ambulance Transportation Code List  Ambulance Bundled Code List Durable Medical Nov. 1, 2015  Revised list of Items Eligible for Rental and Purchase Modifiers Equipment, Rental or Purchase (attachment Some DME items are eligible for rental as well as for purchase. The codes Orthotics and file detailing codes eligible for representing these items are listed in Items Eligible for Rental or Purchase in Prosthetics Multiple rental or purchase that must be the Attachments section of the policy and must be reported with the Frequency reported with an appropriate appropriate rental or purchase modifier in order to be considered for rental or purchase modifier): reimbursement. o Added E0202, E0618, E0619, E0766, E0779, E0781, E0935, Some DME items are eligible for rental only. The codes representing these E0988, E1405, E1406, E1811, items are listed in Items Eligible for Rental Only in the Attachments section E1831, K0009, and K0606 of the policy and must be reported with the appropriate rental modifier in

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REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Durable Medical Nov. 1, 2015 o Removed E1392 order to be considered for reimbursement. Equipment,  Revised list of Items Eligible for Orthotics and Rental Only (attachment file Rental guidelines are explained further in the sections titled Monthly Rental Prosthetics Multiple detailing codes eligible for rental and Daily Rental. Frequency only that must be reported with (continued) an appropriate rental modifier): Rental Modifiers o Added E1392 The following modifiers indicate that an item has been rented: o Removed E0202, E0618,  RR - Rental E0619, E0766, E0779, E0781,  KH - Initial Claim, purchase or first month rental E0935, E0988, E1405, E1406,  KI - Second or third monthly rental E1811, E1831, K0009, and  KJ - Capped rental months four to fourteen K0606  KR - Partial month

Purchase Modifiers

The following modifiers indicate that an item has been purchased:

 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

Monthly Rental Monthly rental of DME, Orthotics, or Prosthetics identified by the applicable code with a rental modifier RR and/or modifiers KH, KI, KJ, KR appended will be reimbursed once per Calendar month to the Same Specialty Physician or Other Health Care Professional. A Calendar Month is the period of duration from a day of one month to the corresponding day of the next month and is determined based on the “From” date reported on the claim.

If a code is submitted with modifier RR and/or modifiers KH, KI, KJ, KR with units greater than 1, or multiple times during the same Calendar Month, Oxford will only reimburse one monthly rate per Calendar Month to the Same Specialty Physician or Other Health Care Professional except where noted below.

Modifiers RT and LT  An additional rental rate will be allowed in the same Calendar Month for

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REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Durable Medical Nov. 1, 2015 codes with a rental modifier when both modifiers RT and LT are submitted Equipment, for the same HCPCS code on separate lines. Modifiers RT and LT may be Orthotics and used to report an item for the right or left side of the body. Use of these Prosthetics Multiple modifiers may convey that multiples of that item are being utilized. Frequency  Backup Ventilator: One additional rental rate will be allowed in the (continued) same Calendar Month for a backup ventilator reported with a rental modifier plus modifier TW (backup equipment), appended to HCPCS codes E0450, E0460, E0461, E0463 or E0464.

Codes with Extension/Flexion, Supination/Pronation, or Each in the Description Up to two rental rates will be allowed in the same Calendar Month for codes with "extension/flexion," "supination/pronation" or "each" in the description. These codes describe services where multiple devices may be reported. If these codes are reported with modifiers RT and LT and multiple units, Oxford will consider for separate reimbursement up to two units for each side for a total of up to four rental rates in the same Calendar Month.

Reporting Monthly Rental Monthly rental of DME, Orthotics, or Prosthetics should be reported on a 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form according to the National Uniform Billing Committee (NUBC) and the National Uniform Claim Committee (NUCC) guidelines.

The appropriate HCPCS code and rental modifier are submitted with one unit for each Calendar Month time span. The rental initiation date is entered in the "From" field, and the end date in the "To" field.

In the following example, the rental for HCPCS code E1130 (Standard wheelchair, fixed full-length arms, fixed or swing-away detachable footrests), is initiated on 1/10/2013, and the item is rented for 3 months, ending on 4/9/2013. The claim should be submitted as follows:

Code Modifier Units From Date To Date E1130 RR 1 1/10/2013 2/9/2013

E1130 RR 1 2/10/2013 3/9/2013

E1130 RR 1 3/10/2013 4/9/2013

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REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Durable Medical Nov. 1, 2015 E1130-RR reported with 3 units, a From Date of 1/10/2013 and a To Date of Equipment, 4/9/2013 on one line will result in reimbursement of only 1 unit. Orthotics and Prosthetics Multiple Daily Rental Frequency Oxford will allow a daily rental for the following items to the Same Specialty (continued) Physician or Other Health Care Professional.

HCPCS codes E0935 (Continuous passive motion exercise device for use on knee only), and E0936 (Continuous passive motion exercise device for use other than knee) are reimbursed on a daily basis consistent with CMS guidelines.

The following HCPCS codes are also reimbursed on a daily basis:  E0193 - Powered air flotation bed (low air loss therapy)  E0194 - Air fluidized bed  E0277 - Powered pressure-reducing air mattress  E0304 - Hospital bed, heavy duty, extra wide, with weight capacity greater than 600 pounds, with any type side rails, with mattress

 E0371 - Nonpowered advanced pressure reducing overlay for mattress,

standard mattress length and width

 E0372 - Powered air overlay for mattress, standard mattress length and

width

 E0373 - Nonpowered advanced pressure reducing mattress  E1639 - Scale, each  E2402 - Negative pressure wound therapy electrical pump, stationary or portable

Maintenance and Service Fees Oxford allows for reimbursement of maintenance and service once every six months to the Same Specialty Physician or Other Health Care Professional. The appropriate HCPCS code appended with modifier MS (maintenance/service fee) is required to identify such services. The Maintenance and Service modifier (MS), must be reported on a separate line in order to be considered for separate reimbursement from the rental or purchase of the equipment.

Maintenance and Service agreements include the following:

 Regular routine maintenance and performance checks as required to

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REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Durable Medical Nov. 1, 2015 maintain the warranty or performance standards Equipment,  Re-education Orthotics and  Compliance with alerts and recalls Prosthetics Multiple  necessary supplies in accordance with the applicable agreement Frequency  Back-up equipment (continued)  Emergency availability and replacement equipment when out-of-service

for repair

For the purposes of this policy, maintenance and servicing does not apply to Orthotics or Prosthetics.

HCPCS Codes A9900, A9901 and L9900 Delivery, set-up and supplies are included in the payment rates associated with a DME, Orthotic, or Prosthetic item. They are not reimbursable services when submitted alone or with another service.

Therefore, Oxford will not separately reimburse the following codes:  A9900 - Miscellaneous DME supply, accessory, and/or service component of another HCPCS code  A9901 - DME delivery, set up, and/or dispensing service component of another HCPCS code  L9900 - Orthotic and prosthetic supply, accessory, and/or service component of another HCPCS "L" code

Microsurgery Policy Nov. 1, 2015  Updated application policy CPT Code 64727 language to indicate this policy Consistent with the CPT book coding guidelines for CPT code 64727, Oxford applies to all network and non- will only reimburse CPT code 64727 when submitted with internal neurolysis network physicians and other codes on the list of Services Allowed with CPT 64627. qualified health care The Centers for Medicare and Medicaid Services (CMS) Medicare Claims professionals, including, but not Processing Manual and the Correct Coding Initiative (CCI) state that CPT limited to, non-network code 69990 is not to be reported in addition to CPT code 64727. authorized and percent of charge

contract physicians and other CPT Code 69990 qualified health care CMS reimbursement guidelines differ from the CPT book coding guidelines. professionals Oxford follows CMS reimbursement guidelines for reimbursement of 69990  Revised list of Services Allowed with certain nervous system surgeries. with CPT 69990 (attachment file

detailing CPT codes for services Oxford will reimburse CPT code 69990 when billed in conjunction with that are reimbursed when

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Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Microsurgery Policy Nov. 1, 2015 submitted with CPT code 69990); services described in the List of Services Allowed with CPT 69990. (continued) removed 61334, 61440, 61470, 61490, 61542, 61609 and 64870

Obstetrical Policy Oct. 1, 2015  Updated reimbursement Refer to the policy for complete details on applicable reimbursement guidelines for Services Excluded guidelines. from the Global Obstetrical Package; updated language to include reference to applicable ICD-10-CM diagnosis code Z32.01 (encounter for pregnancy test, result positive as a service excluded from the global obstetrical package)  Updated lists of applicable codes: o Added lists of applicable ICD- 10- CM codes: . High Risk/Complication ICD-10-Diagnosis Codes (a list of ICD-10-CM diagnosis codes identifying complications or high risk conditions) . Obstetrical Related ICD-10- CM Diagnosis Codes (a list of ICD-10-CM diagnosis codes related to obstetrics) o Added language to indicate ICD-10-CM (diagnoses) and ICD-10-PCS (inpatient procedures) must be used to report services provided on or after 10/01/2015: . ICD-9 codes will not be accepted for services provided on or after 10/01/2015 . ICD-10 codes will not be accepted for services

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REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Obstetrical Policy Oct. 1, 2015 provided prior to (continued) 10/01/2015  Updated Questions and Answers (Q&A); added Q&A #1 pertaining to antepartum services when the “from” and “to” dates span across ICD-9-CM to ICD-10-CM code sets and global maternity service codes are used

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