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  • Lucentis (Ranibizumab) Page 1 of 6 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/09/2018

    Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

    LUCENTIS (RANIBIZUMAB) Guideline Number: MPG193.05 Approval Date: May 9, 2018 Table of Contents Page TERMS AND CONDITIONS ......................................... 1 PURPOSE ................................................................ 1 POLICY SUMMARY .................................................... 2 APPLICABLE CODES ................................................. 4 DEFINITIONS .......................................................... 4 REFERENCES ........................................................... 5 GUIDELINE HISTORY/REVISION INFORMATION ........... 6 TERMS AND CONDITIONS

    The Medicare Advantage Policy Guidelines are applicable to UnitedHealthcare Medicare Advantage Plans offered by UnitedHealthcare and its affiliates. These Policy Guidelines are provided for informational purposes, and do not constitute medical advice. Treating physicians and healthcare providers are solely responsible for determining what care to provide to their patients. Members should always consult their physician before making any decisions about medical care.

    Benefit coverage for health services is determined by the member specific benefit plan document* and applicable laws that may require coverage for a specific service. The member specific benefit plan document identifies which services are covered, which are excluded, and which are subject to limitations. In the event of a conflict, the member specific benefit plan document supersedes the Medicare Advantage Policy Guidelines. Medicare Advantage Policy Guidelines are developed as needed, are regularly reviewed and updated, and are subject to change. They represent a portion of the resources used to support UnitedHealthcare coverage decision making.

    UnitedHealthcare may modify these Policy Guidelines at any time by publishing a new version of the policy on this website. Medicare source materials used to develop these guidelines include, but are not limited to, CMS National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), Medicare Benefit Policy Manual, Medicare Claims Processing Manual, Medicare Program Integrity Manual, Medicare Managed Care Manual, etc. The information presented in the Medicare Advantage Policy Guidelines is believed to be accurate and current as of the date of publication, and is provided on an "AS IS" basis. Where there is a conflict between this document and Medicare source

    materials, the Medicare source materials will apply. You are responsible for submission of accurate claims. Medicare Advantage Policy Guidelines are intended to ensure that coverage decisions are made accurately based on the code or codes that correctly describe the health care services provided. UnitedHealthcare Medicare Advantage Policy Guidelines use Current Procedural Terminology (CPT**), Centers for Medicare and Medicaid Services (CMS), or other coding guidelines. References to CPT or other sources are for definitional purposes only and do not imply any right to reimbursement or guarantee claims payment.

    Medicare Advantage Policy Guidelines are the property of UnitedHealthcare. Unauthorized copying, use and

    distribution of this information are strictly prohibited. *For more information on a specific member's benefit coverage, please call the customer service number on the back of the member ID card or refer to the Administrative Guide. **CPT is a registered trademark of the American Medical Association.

    PURPOSE

    The Medicare Advantage Policy Guideline documents are generally used to support UnitedHealthcare Medicare Advantage claims processing activities and facilitate providers submission of accurate claims for the specified services. The document can be used as a guide to help determine applicable: Medicare coding or billing requirements, and/or Medical necessity coverage guidelines; including documentation requirements.

    Related Medicare Advantage Policy Guideline

    Self-Administered Drug(s) (SAD)

    Related Medicare Advantage Coverage Summaries

    Age Related Macular Degeneration (AMD) Therapy: (Macugen, Lucentis, Avastin, EYLEA)

    Vision Services, Therapy and Rehabilitation

    UnitedHealthcare Medicare Advantage Policy Guideline

    https://www.uhcprovider.com/en/admin-guides.htmlhttps://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-guidelines/s/self-administered-drugs-sad.pdfhttps://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-coverage-sum/age-related-macular-degeneration-amd-macugen-lucentis-avastin-eylea.pdfhttps://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-coverage-sum/age-related-macular-degeneration-amd-macugen-lucentis-avastin-eylea.pdfhttps://www.uhcprovider.com/content/dam/provider/docs/public/policies/medadv-coverage-sum/vision-services-therapy-rehabilitation.pdf

  • Lucentis (Ranibizumab) Page 2 of 6 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/09/2018

    Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

    UnitedHealthcare follows Medicare guidelines such as LCDs, NCDs, and other Medicare manuals for the purposes of determining coverage. It is expected providers retain or have access to appropriate documentation when requested to support coverage. Please utilize the links in the References section below to view the Medicare source materials used to develop this resource document. This document is not a replacement for the Medicare source materials that outline

    Medicare coverage requirements. Where there is a conflict between this document and Medicare source materials, the Medicare source materials will apply. POLICY SUMMARY Overview Ranibizumab (Lucentis), is a recombinant humanized immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody

    fragment designed for intraocular use, is a vascular endothelial growth factor A (VEGF-A) antagonist. Ranibizumab binds to active forms of human VEGF-A, including the cleaved form (VEGF 110), and inhibits their biologic activity. VEGF-A induces neovascularization (angiogenesis) and increases vascular permeability, which appears to play a role in the pathogenesis and progression of the neovascular (wet) form of age-related macular degeneration (AMD), a leading cause of blindness in adults older than 60 years of age in developed countries. Binding of ranibizumab to

    VEGF-A prevents VEGF-A from binding to VEGF receptors (i.e., VEGFR-1, VEGFR-2) on the surface of endothelial cells, reducing endothelial cell proliferation, angiogenesis, and vascular permeability.

    Ranibizumab was approved by the Food and Drug Administration (FDA) on June 30, 2006 for the treatment of patients with exudative senile macular degeneration. Effective June 22, 2010, the Food and Drug Administration (FDA) approved ranibizumab for macular edema following retinal vein occlusion (RVO). Effective August 10, 2012, the Food and Drug Administration (FDA) approved ranibizumab for diabetic macular edema.

    Guidelines This policy defines coding and coverage for Ranibizumab including off-label indications. The recommended dosage and frequency of treatment is 0.3mg/0.3 ml or 0.5 mg/0.05 mL (10mg/mL) administered by intravitreal injection once a month (approximately 28 days). Treatment may be continued monthly or reduced to one injection every three months after the first four injections, if monthly treatments are not feasible. Compared to monthly dosing, however, it is expected that quarterly dosing may be less effective, and as such, patients should be evaluated at regular regimens.

    The administration for ranibizumab must be billed on the same claim as the drug, with CPT code 67028 (intravitreal injection of a pharmacologic agent). As published in CMS IOM CMS Program Integrity Manual, Section 13.5.1, in order to be covered under Medicare, a

    service shall be reasonable and necessary. UHC shall consider a service to be reasonable and necessary if we determine that the service is:

    Safe and effective. Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of

    service on or after September 19, 2000, that meet the requirements of the Clinical Trials NCD are considered reasonable and necessary).

    Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is: o Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the

    patient's condition or to improve the function of a malformed body member. o Furnished in a setting appropriate to the patient's medical needs and condition. o Ordered and furnished by qualified personnel. o One that meets, but does not exceed, the patient's medical needs. o At least as beneficial as an existing and available medically appropriate alternative.

    Drugs and biologicals must be determined to meet the statutory definition. Under the statue 1861(t) (1) Drugs and

    Biologicals, The term drugs and the term biologicals, except for purposes of subsection (m)(5) and paragraph (2), include only such drugs (including contrast agents) and biologicals, respectively, as are included (or approved for inclusion) in the United States Pharmacopoeia, the National Formulary, or the United States Homeopathic Pharmacopoeia, or in New Drugs or Accepted Dental Remedies (except for any drugs and biologicals unfavorably evaluated therein), or as are

    approved by the pharmacy and drug therapeutics committee (or equivalent committee) of the medical staff of the hospital furnishing such drugs and biologicals for use in such hospital. An unlabeled use of a drug is a use that is not included as an indication on the drug's label as approved by the FDA. FDA approved drugs used for indications other than what is indicated on the official label may be covered by UHC if we determine the use to be medically accepted, taking into consideration the major drug compendia, authoritative

    http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c13.pdfhttp://www.ssa.gov/OP_Home/ssact/title18/1861.htmhttp://www.ssa.gov/OP_Home/ssact/title18/1861.htm

  • Lucentis (Ranibizumab) Page 3 of 6 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/09/2018

    Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

    medical literature and/or accepted standards of medical practice. The following guidelines identify three categories in which medications would not be reasonable and necessary according to accepted standards of medical practice. Not for Particular Illness Medications given for a purpose other than the treatment of a particular condition,

    illness, or injury are not covered (except for certain immunizations).

    Injection Method Not Indicated Medication given by injection (parenterally) is not covered if standard medical practice indicates that the administration of the medication by mouth (orally) is effective and is an accepted or preferred method of administration.

    Excessive Medications Medications administered for treatment of a disease which exceed the frequency or duration of injections indicated by accepted standards of medical practice are not covered.

    If a medication is determined not to be reasonable and necessary for diagnosis or treatment of an illness or injury

    according to these guidelines, the entire charge will be excluded (i.e., for both the drug and its administration). Also excluded from payment is any charge for other services (such as office visits) which are primarily for the purpose of administering a noncovered injection (i.e., an injection that is not reasonable and necessary for the diagnosis or treatment of an illness or injury). A drug that is less than effective is not eligible for reimbursement, i.e., one that the Food and Drug Administration has

    determined to lack substantial evidence of effectiveness for all labeled indications. Any other drug product that is identical, similar, or related, will also be ineligible.

    If a use is identified as not indicated by CMS or the FDA or if a use is specifically identified as not indicated (in one or more of the three compendia mentioned) or if it is determined (based on peer reviewed medical literature) that a particular use of a drug is not safe and effective, the off-label usage is not supported and, therefore, the drug is not covered. In this instance, the administration is also not covered.

    Medicare Benefit Policy Manual - Pub. 100-02, Chapter 15, Section 50, describes national policy regarding Medicare guidelines for coverage of drugs and biologicals. Coverage for medication is based on the patient's condition, the appropriateness of the dose and route of administration, based on the clinical condition and the standard of medical practice regarding the effectiveness of the drug for the diagnosis and condition. The drug must be used according to the indication and protocol listed in the

    accepted compendia ratings listed below. National Comprehensive Cancer Network (NCCN) Drugs and Biologies Compendium Thomson Micromedex DrugDex American Hospital Formulary Service-Drug Information (AHFS-DI)

    Clinical Pharmacology

    Drug Wastage Medicare provides payment for the discarded drug/biological remaining in a single-use drug product after administering what is reasonable and necessary for the patients condition. If the physician has made good faith efforts to minimize the unused portion of the drug/biological in how patients are scheduled and how he ordered, accepted, stored and used the drug, and made good faith efforts to minimize the unused portion of the drug in how it is supplied, the program will cover the amount of drug discarded along with the amount administered. Documentation requirements are given below. Refer to national policy: Medicare Claims Processing Manual Chapter 17 - Drugs and

    Biologicals, 40 Note: The JW modifier is not used on claims for drugs or biologicals provided under the Competitive Acquisition Program (CAP). Reference to national policy: Medicare Claims Processing Manual, Pub. Chapter 17 - Drugs and Biologicals, 100.2.9

    Documentation Requirements

    Documentation is expected to be maintained in the patients medical record and to be available to UHC upon request. Every page of the record is expected to be legible and include both the appropriate patient identification information (e.g., complete name dates of service(s), and information identifying the physician or non-physician practitioner responsible for and providing the care of the patient. The patient's medical record must contain documentation that fully supports the medical necessity for services. This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

    The medical record must include the following information: A physician's order The name of the drug or biological administered; The route of administration; The dosage (e.g., mgs, mcgs, cc's or IU's);

    http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdfhttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdfhttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdfhttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdf

  • Lucentis (Ranibizumab) Page 4 of 6 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/09/2018

    Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

    When a portion of the drug or biological is discarded, the medical record must clearly document the amount administered and the amount wasted or discarded.

    APPLICABLE CODES The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.

    CPT Code Description

    67028 Intravitreal injection of a pharmacologic agent (separate procedure)

    CPT is a registered trademark of the American Medical Association

    HCPCS Code Description

    J2778 Injection, Ranibizumab, 0.1 mg

    Modifier Description

    LT Left side (used to identify procedures performed on the left side of the body)

    RT Right side (used to identify procedures performed on the right side of the body)

    50 Bilateral procedure

    JW Drug amount discarded/not administered to any patient

    EJ Subsequent doses in a series

    ICD-10 Diagnosis Codes

    Lucentis ICD-10 Dx Coding.xls

    DEFINITIONS Drug Wastage: The CMS encourages physicians, hospitals and other providers to schedule patients in such a way that they can use drugs or biologicals most efficiently, in a clinically appropriate manner. However, if a physician,

    hospital or other provider must discard the remainder of a single use vial or other single use package after administering a dose/quantity of the drug or biological to a Medicare patient, the program provides payment for the amount of drug or biological discarded along with the amount administered, up to the amount of the drug or biological as indicated on the vial or package label. Medical record documentation must clearly indicate the amount of drug administered and the amount wasted. When billing drugs, units of service must be billed in multiples of the dosage specified in the full HCPCS descriptor. This descriptor does not always match the dose given. The units billed must correspond with the smallest dose (vial) available for purchase from the manufacturer(s) that could provide the

    appropriate dose for the patient. The following examples will help illustrate some of these points: Example of choice of vial size 1. HCPCS for drug A indicates 1 unit = 30 mg 2. Drug A doses available from the manufacturer: 60 mg vial and 90 mg vial 3. The amount prescribed for the patient is 48 mg. If the provider uses a 90 mg vial to administer the dose, the

    provider may only bill only 2 units (rather than 3 units) as the doses available from the manufacturer allow the prescribed amount to be administered with a 60 mg vial.

    Additionally, if after administering the prescribed dosage of any given drug, the provider must discard the remainder of a single-use vial or other package, Medicare may cover the amount of the drug discarded along with the amount administered. Off-Label Drug Use: An off-label/unlabeled use of a drug is defined as a use for a non-FDA approved indication, that

    is, one that is not listed on the drug's official label/prescribing information. An indication is defined as a diagnosis, illness, injury, syndrome, condition, or other clinical parameter for which a drug may be given. Off-label use is further defined as giving the drug in a way that deviates significantly from the labeled prescribing information for a particular indication. This includes but is not necessarily limited to, dosage, route of administration, duration and frequency of administration, and population to whom the drug would be administered. Drugs used for indications other than those

    Sheet1

    ICD-10 Diagnosis CodeDescription

    E08.311Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

    E08.319Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy without macular edema (Effective 4/15/2017)

    E08.3211Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, right eye

    E08.3212Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, left eye

    E08.3213Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, bilateral

    E08.3219Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E08.3291Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E08.3292Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E08.3293Diabetes mellitus due to underlying condition with mild nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E08.3311Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, right eye

    E08.3312Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, left eye

    E08.3313Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

    E08.3319Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E08.3391Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E08.3392Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E08.3393Diabetes mellitus due to underlying condition with moderate nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E08.3411Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, right eye

    E08.3412Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, left eye

    E08.3413Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, bilateral

    E08.3419Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E08.3491Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E08.3492Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E08.3493Diabetes mellitus due to underlying condition with severe nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E08.3511Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, right eye

    E08.3512Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, left eye

    E08.3513Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, bilateral

    E08.3519Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E08.3521Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

    E08.3522Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

    E08.3523Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

    E08.3531Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

    E08.3532Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

    E08.3533Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

    E08.3541Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

    E08.3542Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

    E08.3543Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

    E08.3551Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, right eye

    E08.3552Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, left eye

    E08.3553Diabetes mellitus due to underlying condition with stable proliferative diabetic retinopathy, bilateral

    E08.3591Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, right eye

    E08.3592Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, left eye

    E08.3593Diabetes mellitus due to underlying condition with proliferative diabetic retinopathy without macular edema, bilateral

    E09.311Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy with macular edema

    E09.319Drug or chemical induced diabetes mellitus with unspecified diabetic retinopathy without macular edema (Effective 4/15/2017)

    E09.3211Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

    E09.3212Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

    E09.3213Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

    E09.3219Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E09.3291Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E09.3292Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E09.3293Drug or chemical induced diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E09.3311Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

    E09.3312Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

    E09.3313Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

    E09.3319Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E09.3391Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E09.3392Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E09.3393Drug or chemical induced diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E09.3411Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

    E09.3412Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

    E09.3413Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

    E09.3419Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E09.3491Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E09.3492Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E09.3493Drug or chemical induced diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E09.3511Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

    E09.3512Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

    E09.3513Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

    E09.3519Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E09.3521Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

    E09.3522Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

    E09.3523Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

    E09.3531Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

    E09.3532Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

    E09.3533Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

    E09.3541Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

    E09.3542Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

    E09.3543Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

    E09.3551Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, right eye

    E09.3552Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, left eye

    E09.3553Drug or chemical induced diabetes mellitus with stable proliferative diabetic retinopathy, bilateral

    E09.3591Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye

    E09.3592Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye

    E09.3593Drug or chemical induced diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral

    E10.311Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema

    E10.319Type 1 diabetes mellitus with unspecified diabetic retinopathy without macular edema (Effective 4/15/2017)

    E10.3211Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

    E10.3212Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

    E10.3213Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

    E10.3219Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E10.3291Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E10.3292Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E10.3293Type 1 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E10.3311Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

    E10.3312Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

    E10.3313Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

    E10.3319Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E10.3391Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E10.3392Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E10.3393Type 1 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E10.3411Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

    E10.3412Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

    E10.3413Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

    E10.3419Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E10.3491Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E10.3492Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E10.3493Type 1 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E10.3511Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

    E10.3512Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

    E10.3513Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

    E10.3519Type 1 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E10.3521Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

    E10.3522Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

    E10.3523Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

    E10.3531Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

    E10.3532Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

    E10.3533Type 1 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

    E10.3541Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

    E10.3542Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

    E10.3543Type 1 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

    E10.3551Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, right eye

    E10.3552Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, left eye

    E10.3553Type 1 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral

    E10.3591Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye

    E10.3592Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye

    E10.3593Type 1 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral

    E11.311Type 2 diabetes mellitus with unspecified diabetic retinopathy with macular edema

    E11.319Type 2 diabetes mellitus with unspecified diabetic retinopathy without macular edema (Effective 4/15/2017)

    E11.319Add to Policy/417

    E11.3211Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

    E11.3212Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, left eye

    E11.3213Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

    E11.3219Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E11.3291Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E11.3292Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E11.3293Type 2 diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E11.3311Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

    E11.3312Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

    E11.3313Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

    E11.3319Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E11.3391Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E11.3392Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E11.3393Type 2 diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E11.3411Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

    E11.3412Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

    E11.3413Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

    E11.3419Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E11.3491Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E11.3492Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E11.3493Type 2 diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E11.3511Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

    E11.3512Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

    E11.3513Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

    E11.3519Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E11.3521Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

    E11.3522Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

    E11.3523Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

    E11.3531Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

    E11.3532Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

    E11.3533Type 2 diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

    E11.3541Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

    E11.3542Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

    E11.3543Type 2 diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

    E11.3551Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, right eye

    E11.3552Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, left eye

    E11.3553Type 2 diabetes mellitus with stable proliferative diabetic retinopathy, bilateral

    E11.3591Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye

    E11.3592Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye

    E11.3593Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral

    E13.311Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema

    E13.319Other specified diabetes mellitus with unspecified diabetic retinopathy without macular edema (Effective 4/15/2017)

    E13.3211Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

    E13.3212Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, right eye

    E13.3213Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, bilateral

    E13.3219Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E13.3291Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E13.3292Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E13.3293Other specified diabetes mellitus with mild nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E13.3311Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, right eye

    E13.3312Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, left eye

    E13.3313Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, bilateral

    E13.3319Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E13.3391Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E13.3392Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E13.3393Other specified diabetes mellitus with moderate nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E13.3411Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, right eye

    E13.3412Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, left eye

    E13.3413Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, bilateral

    E13.3419Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E13.3491Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, right eye (Effective 4/15/2017)

    E13.3492Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, left eye (Effective 4/15/2017)

    E13.3493Other specified diabetes mellitus with severe nonproliferative diabetic retinopathy without macular edema, bilateral (Effective 4/15/2017)

    E13.3511Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, right eye

    E13.3512Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, left eye

    E13.3513Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, bilateral

    E13.3519Other specified diabetes mellitus with proliferative diabetic retinopathy with macular edema, unspecified eye (removed effective 5/9/18)

    E13.3521Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, right eye

    E13.3522Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, left eye

    E13.3523Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment involving the macula, bilateral

    E13.3531Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, right eye

    E13.3532Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, left eye

    E13.3533Other specified diabetes mellitus with proliferative diabetic retinopathy with traction retinal detachment not involving the macula, bilateral

    E13.3541Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, right eye

    E13.3542Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, left eye

    E13.3543Other specified diabetes mellitus with proliferative diabetic retinopathy with combined traction retinal detachment and rhegmatogenous retinal detachment, bilateral

    E13.3551Other specified diabetes mellitus with stable proliferative diabetic retinopathy, right eye

    E13.3552Other specified diabetes mellitus with stable proliferative diabetic retinopathy, left eye

    E13.3553Other specified diabetes mellitus with stable proliferative diabetic retinopathy, bilateral

    E13.3591Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, right eye

    E13.3592Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, left eye

    E13.3593Other specified diabetes mellitus with proliferative diabetic retinopathy without macular edema, bilateral

    H34.8110Central retinal vein occlusion, right eye, with macular edema

    H34.8111Central retinal vein occlusion, right eye, with retinal neovascularization

    H34.8112Central retinal vein occlusion, right eye, stable

    H34.8120Central retinal vein occlusion, left eye, with macular edema

    H34.8121Central retinal vein occlusion, left eye, with retinal neovascularization

    H34.8122Central retinal vein occlusion, left eye, stable

    H34.8130Central retinal vein occlusion, bilateral, with macular edema

    H34.8131Central retinal vein occlusion, bilateral, with retinal neovascularization

    H34.8132Central retinal vein occlusion, bilateral, stable

    H34.8190Central retinal vein occlusion, unspecified eye, with macular edema (removed effective 5/9/18)

    H34.8191Central retinal vein occlusion, unspecified eye, with retinal neovascularization (removed effective 5/9/18)

    H34.8192Central retinal vein occlusion, unspecified eye, stable (removed effective 5/9/18)

    H34.8310Tributary (branch) retinal vein occlusion, right eye, with macular edema

    H34.8311Tributary (branch) retinal vein occlusion, right eye, with retinal neovascularization

    H34.8312Tributary (branch) retinal vein occlusion, right eye, stable

    H34.8320Tributary (branch) retinal vein occlusion, left eye, with macular edema

    H34.8321Tributary (branch) retinal vein occlusion, left eye, with retinal neovascularization

    H34.8322Tributary (branch) retinal vein occlusion, left eye, stable

    H34.8330Tributary (branch) retinal vein occlusion, bilateral, with macular edema

    H34.8331Tributary (branch) retinal vein occlusion, bilateral, with retinal neovascularization

    H34.8332Tributary (branch) retinal vein occlusion, bilateral, stable

    H34.8390Tributary (branch) retinal vein occlusion, unspecified eye, with macular edema (removed effective 5/9/18)

    H34.8391Tributary (branch) retinal vein occlusion, unspecified eye, with retinal neovascularization (removed effective 5/9/18)

    H34.8392Tributary (branch) retinal vein occlusion, unspecified eye, stable (removed effective 5/9/18)

    H35.051Retinal neovascularization, unspecified, right eye

    H35.052Retinal neovascularization, unspecified, left eye

    H35.053Retinal neovascularization, unspecified, bilateral

    H35.3210Exudative age-related macular degeneration, right eye, stage unspecified

    H35.3211Exudative age-related macular degeneration, right eye, with active choroidal neovascularization

    H35.3212Exudative age-related macular degeneration, right eye, with inactive choroidal neovascularization

    H35.3213Exudative age-related macular degeneration, right eye, with inactive scar

    H35.3220Exudative age-related macular degeneration, left eye, stage unspecified

    H35.3221Exudative age-related macular degeneration, left eye, with active choroidal neovascularization

    H35.3222Exudative age-related macular degeneration, left eye, with inactive choroidal neovascularization

    H35.3223Exudative age-related macular degeneration, left eye, with inactive scar

    H35.3230Exudative age-related macular degeneration, bilateral, stage unspecified

    H35.3231Exudative age-related macular degeneration, bilateral, with active choroidal neovascularization

    H35.3232Exudative age-related macular degeneration, bilateral, with inactive choroidal neovascularization

    H35.3233Exudative age-related macular degeneration, bilateral, with inactive scar

    H35.3290Exudative age-related macular degeneration, unspecified eye, stage unspecified (removed effective 5/9/18)

    H35.3291Exudative age-related macular degeneration, unspecified eye, with active choroidal neovascularization (removed effective 5/9/18)

    H35.3292Exudative age-related macular degeneration, unspecified eye, with inactive choroidal neovascularization (removed effective 5/9/18)

    H35.3293Exudative age-related macular degeneration, unspecified eye, with inactive scar (removed effective 5/9/18)

    H35.351Cystoid macular degeneration, right eye

    H35.352Cystoid macular degeneration, left eye

    H35.353Cystoid macular degeneration, bilatera

    H35.359Cystoid macular degeneration, unspecified eye (removed effective 5/9/18)

    H35.81Retinal edema

    H44.21Degenerative myopia, right eye (effective 1/5/17)

    H44.22Degenerative myopia, left eye (effective 1/5/17)

    H44.23Degenerative myopia, bilateral (effective 1/5/17)

    H44.2A1Degenerative myopia with choroidal neovascularization, right eye (effective 1/5/17)

    H44.2A2Degenerative myopia with choroidal neovascularization, left eye (effective 1/5/17)

    H44.2A3Degenerative myopia with choroidal neovascularization, bilateral eye (effective 1/5/17)

    H44.2B1Degenerative myopia with macular hole, right eye (effective 1/5/17)

    H44.2B2Degenerative myopia with macular hole, left eye (effective 1/5/17)

    H44.2B3Degenerative myopia with macular hole, bilateral eye (effective 1/5/17)

    H44.2C1Degenerative myopia with retinal detachment, right eye (effective 1/5/17)

    H44.2C2Degenerative myopia with retinal detachment, left eye (effective 1/5/17)

    H44.2C3Degenerative myopia with retinal detachment, bilateral eye (effective 1/5/17)

    H44.2D1Degenerative myopia with foveoschisis, right eye (effective 1/5/17)

    H44.2D2Degenerative myopia with foveoschisis, left eye (effective 1/5/17)

    H44.2D3Degenerative myopia with foveoschisis, bilateral eye (effective 1/5/17)

    H44.2E1Degenerative myopia with other maculopathy, right eye (effective 1/5/17)

    H44.2E2Degenerative myopia with other maculopathy, left eye (effective 1/5/17)

    H44.2E3Degenerative myopia with other maculopathy, bilateral eye (effective 1/5/17)

    Sheet2

    Sheet3

  • Lucentis (Ranibizumab) Page 5 of 6 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/09/2018

    Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

    in the approved labeling may be covered under Medicare if it is determined that the use is medically accepted, taking into consideration the major drug compendia, authoritative medical literatures and/or accepted standards of medical practice. Determinations as to whether medication is reasonable and necessary for an individual patient are made on appeal on the same basis as all other such determinations (i.e., with support from the peer-reviewed literature, with

    the advice of medical consultants, with reference to accepted standards of medical practice, and in consideration of the medical circumstance of the individual case). REFERENCES

    CMS Local Coverage Determinations (LCDs)

    LCD Medicare Part A Medicare Part B-19

    L34741 (Drugs and Biologics (Non-chemotherapy) WPS

    AK, AL, AR, AZ, CT, FL, GA, IA, ID,

    IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, OH, OR, RI, SC, SD, TN, UT, VA, VI, VT, WA, WI, WV, WY

    IA, IN, KS, MI, MO, NE

    L33394 (Drugs and Biologicals,

    Coverage of, for Label and Off-Label Uses) NGS

    CT, IL, MA, ME, MN, NH, NY (Entire State), RI, VT, WI

    CT, IL, MA, ME, MN, NH, NY (Down

    State), NY (Upstate), NY (Queens), RI, VT, WI

    L36962 (Vascular Endothelial Growth Factor Inhibitors for the Treatment of Ophthalmological Disease) First Coast

    FL, PR, VI FL, PR, VI

    L33407 (Ranibizumab (Lucentis)) First Coast Retired 07/24/2017

    FL, PR, VI FL, PR, VI

    L34252 (Drugs and Biologicals: Antiangiogenic Therapy for Ophthalmic Conditions) Cahaba Retired 09/30/2016

    AL, GA, TN AL, GA, TN

    CMS Articles

    Article Medicare Part A Medicare Part B

    A53121 (Billing and Coding Information Regarding Uses, Including Off-Label Uses, of

    Bevacizumab and Ranibizumab, for The Treatment of Ophthalmological Diseases) Novitas

    DC, DE, MD, NJ, PA DC, DE, MD, NJ, PA

    A52451 (Ranibizumab (e.g., Lucentis) and Aflibercept (e.g.,

    Eylea) Related to LCD L33394) NGS

    CT, IL, MA, ME, MN, NH, NY (Entire State), RI, VT, WI

    CT, IL, MA, ME, MN, NH, NY (Down State), NY (Upstate), NY (Queens), RI, VT, WI

    A55311 (Ranibizumab (Lucentis) coding guidelines) First Coast

    FL, PR, VI FL, PR, VI

    A55364 (Ranibizumab (Lucentis)

    revision to the Part A and Part B LCD) First Coast

    FL, PR, VI FL, PR, VI

    A55577 (Ranibizumab (Lucentis) revision to the Part A and Part B LCD) First Coast

    FL, PR, VI FL, PR, VI

    A55649 (Ranibizumab (Lucentis)

    retired Part A and Part B LCD) First Coast Retired 07/24/2017

    FL, PR, VI FL, PR, VI

    CMS Benefit Policy Manual

    Chapter 15; 50 Drugs and Biologicals

    CMS Claims Processing Manual

    Chapter 17; 40 Discarded Drugs and Biologicals, 100.2.9 Submission of Claims with the Modifier JW, Drug Amount Discarded/Not Administered to Any Patient

    UnitedHealthcare Commercial Policies

    Macular Degeneration Treatment Procedures

    https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34741&ver=45&bc=AAAAAAAAIAAAAA%3d%3d&https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34741&ver=45&bc=AAAAAAAAIAAAAA%3d%3d&https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33394&ver=30https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33394&ver=30https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=33394&ver=30https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36962&ver=11https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36962&ver=11https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36962&ver=11https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53121&ver=7https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53121&ver=7https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53121&ver=7https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53121&ver=7https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53121&ver=7https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=53121&ver=7https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52451&ver=18&bc=AAAAAAAAEAAAAA%3d%3d&https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52451&ver=18&bc=AAAAAAAAEAAAAA%3d%3d&https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52451&ver=18&bc=AAAAAAAAEAAAAA%3d%3d&https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=52451&ver=18&bc=AAAAAAAAEAAAAA%3d%3d&https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55311&ver=2https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55311&ver=2https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55364&ver=2https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55364&ver=2https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55364&ver=2https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55577&ver=3https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55577&ver=3https://www.cms.gov/medicare-coverage-database/details/article-details.aspx?articleId=55577&ver=3https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdfhttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdfhttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c17.pdfhttps://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/macular-degeneration-treatment-procedures.pdf

  • Lucentis (Ranibizumab) Page 6 of 6 UnitedHealthcare Medicare Advantage Policy Guideline Approved 05/09/2018

    Proprietary Information of UnitedHealthcare. Copyright 2018 United HealthCare Services, Inc.

    Ophthalmologic Policy: Vascular Endothelial Growth Factor (VEGF) Inhibitors Proton Beam Radiation Therapy

    Others

    CMS Medicare Program Integrity Manual 100-08, 13.5.1 Reasonable and Necessary Provisions in LCDs, CMS Website

    XVIII of the Social Security Act (SSA): 1861(t)(1), Social Security Website

    GUIDELINE HISTORY/REVISION INFORMATION Revisions to this summary document do not in any way modify the requirement that services be provided and documented in accordance with the Medicare guidelines in effect on the date of service in question.

    Date Action/Description

    05/09/2018 Annual review

    https://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/ophthalmologic-vascular-endothelial-growth-factor-inhibitors.pdfhttps://www.uhcprovider.com/content/dam/provider/docs/public/policies/comm-medical-drug/proton-beam-radiation-therapy.pdfhttp://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/pim83c13.pdfhttp://www.socialsecurity.gov/OP_Home/ssact/title18/1861.htm