May 2016 update bulletin · Erectile dysfunction Multiple sclerosis Osteoarthritis Osteoporosis ......

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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 UnitedHealthcare ® Oxford Medical and Administrative Policy updates.* *Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare ® Oxford follows such applicable federal and/or state law. May 2016 policy update bulletin Medical & Administrative Policy Updates

Transcript of May 2016 update bulletin · Erectile dysfunction Multiple sclerosis Osteoarthritis Osteoporosis ......

Page 1: May 2016 update bulletin · Erectile dysfunction Multiple sclerosis Osteoarthritis Osteoporosis ... proven and medically necessary in the evaluation of patients with one or more of

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

UnitedHealthcare® Oxford Medical and Administrative Policy updates.*

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

state law.

May 2016

policy update bulletin Medical & Administrative Policy Updates

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2 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

UnitedHealthcare® Oxford Medical and Administrative Policy Updates

Overview

Tips for using the Policy Update Bulletin:

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

directed to the corresponding policy update summary.

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

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

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review requirements

have been adopted for a service, procedure, test, or device

Updated

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

to the clinical coverage criteria or documentation review requirements;

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

list(s) of applicable codes may have been updated

Revised

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

the clinical coverage criteria and/or documentation review requirements

Replaced

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

Retired

The procedural codes and/or services previously outlined in the policy are

no longer being managed or are considered to be proven/medically

necessary and are therefore not excluded as unproven/not medically

necessary services, unless coverage guidelines or criteria are otherwise

documented in another policy

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

coverage. As always, coverage for a service or procedure must be

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

applicable federal or state regulatory requirements. Additionally,

UnitedHealthcare reserves the right to review the clinical evidence

supporting the safety and effectiveness of a medical technology prior to

rendering a coverage determination.

This bulletin provides complete details on UnitedHealthcare®

Oxford Medical and Administrative Policy updates. The

appearance of a service or procedure in this bulletin indicates

only that Oxford has recently adopted a new policy and/or

updated, revised, replaced or retired an existing policy; it does

not imply that Oxford provides coverage for the service or

procedure. In the event of an inconsistency or conflict between

the information provided in this bulletin and the posted policy,

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

benefit plan documents exclude from benefit coverage health

services identified as investigational or unproven/not medically

necessary. Physicians and other health care professionals may

not seek or collect payment from a member for services not

covered by the applicable benefit plan unless first obtaining the

member’s written consent, acknowledging that the service is not

covered by the benefit plan and that they will be billed directly

for the service.

A complete library of UnitedHealthcare® Oxford Medical

and Administrative Policies is available at

OxfordHealth.com > Providers > Tools & Resources >

Medical Information > Medical and Administrative

Policies.

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UnitedHealthcare® Oxford Medical and Administrative Policy Updates

In This Issue

Clinical Policy Updates Page

UPDATED

Chelation Therapy for Non-Overload Conditions - Effective May 1, 2016 .................................................................................................................. 6 Chromosome Microarray Testing - Effective June 1, 2016 ...................................................................................................................................... 7 Cochlear Implants - Effective May 1, 2016 ........................................................................................................................................................... 8 Collagen Crosslinks and Biochemical Markers of Bone Turnover - Effective May 1, 2016 ............................................................................................ 8 Entyvio® (Vedolizumab) - Effective June 1, 2016 .................................................................................................................................................. 9 Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable - Effective May 1, 2016 ........................................................... 10 Intermittent Intravenous Insulin Therapy - Effective May 1, 2016 ......................................................................................................................... 12 Orencia® (Abatacept) - Injection for Intravenous Infusion - Effective June 1, 2016 ................................................................................................. 12 Thermography - Effective May 1, 2016 .............................................................................................................................................................. 13

REVISED

Actemra® (Tocilizumab) Injection for Intravenous Infusion - Effective June 1, 2016 ................................................................................................ 14 Agents for Migraine - Triptans - Effective June 1, 2016 ........................................................................................................................................ 15 Blepharoplasty, Blepharoptosis and Brow Ptosis Repair - Effective June 1, 2016 ..................................................................................................... 19 Cardiology Procedures Requiring Precertification for eviCore healthcare Arrangement - Effective July 1, 2016 ............................................................ 25 Clinical Trials - Effective June 1, 2016 ............................................................................................................................................................... 28 Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective June 1, 2016 ................................................................................ 32 Drug Coverage Guidelines - Effective June 1, 2016 ............................................................................................................................................. 32

o Actemra (Tocilizumab): SQ Injection ........................................................................................................................................................... 32 o Addyi (Flibanserin) .................................................................................................................................................................................... 32 o Adzenys XR (Amphetamine Extended-Release) ............................................................................................................................................. 32 o Alogliptin (Nesina Authorized Generic) ......................................................................................................................................................... 32 o Alogliptin/Metformin (Kazano Authorized Generic) ......................................................................................................................................... 33 o Alogliptin/Pioglitazone (Oseni Authorized Generic)......................................................................................................................................... 33 o Cimzia (Certolizumab Pegol) ....................................................................................................................................................................... 33 o Cosentyx (Secukinumab) ........................................................................................................................................................................... 33 o Diclegis (Doxylamine Succinate and Pyridoxine Hydrochloride) ....................................................................................................................... 33 o Diclofenac 1% Topical Gel (Generic Voltaren) ............................................................................................................................................... 33 o Emverm (Mebendazole) ............................................................................................................................................................................. 33 o Enbrel (Etanercept) ................................................................................................................................................................................... 34 o Glumetza (Metformin Extended-Release) ..................................................................................................................................................... 34 o Humira (Adalimumab) ............................................................................................................................................................................... 34 o Idelvion (Coagulation Factor IX (Recombinant), Albumin Fusion Protein) .......................................................................................................... 34 o Imitrex (Sumatriptan) (Brand Only) ............................................................................................................................................................ 34

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UnitedHealthcare® Oxford Medical and Administrative Policy Updates

In This Issue

o Kineret (Anakinra) .................................................................................................................................................................................... 34 o Multaq (Dronedarone) ............................................................................................................................................................................... 34 o Orencia (Abatacept): SQ Injection ............................................................................................................................................................... 34 o Otezla (Apremilast) ................................................................................................................................................................................... 34 o Peg-Intron (Peginterferon Alfa-2b) .............................................................................................................................................................. 34 o Rescula (Unoprostone) .............................................................................................................................................................................. 35 o Restasis (Cyclosporine Ophthalmic Emulsion) ............................................................................................................................................... 35 o Sernivo Spray (Betamethasone Dipropionate)............................................................................................................................................... 35 o Simponi (Golimumab) ................................................................................................................................................................................ 35 o Stelara (Ustekinumab) ............................................................................................................................................................................... 35 o Taltz (Ixekizumab) .................................................................................................................................................................................... 35 o Travoprost (Generic Travatan) .................................................................................................................................................................... 35 o Vecamyl (Mecamylamine) .......................................................................................................................................................................... 35 o Xeljanz XR ............................................................................................................................................................................................... 35 o Zegerid Suspension (Omeprazole/Sodium Bicarbonate) ................................................................................................................................. 35 o Zembrace (Sumatriptan Succinate) ............................................................................................................................................................. 35 o Zioptan (Tafluprost) .................................................................................................................................................................................. 36

Omnibus Codes - Effective June 1, 2016 ............................................................................................................................................................ 36 Oxford's Outpatient Imaging Self-Referral - Effective July 1, 2016 ........................................................................................................................ 36 Radiology Procedures Requiring Precertification for eviCore healthcare Arrangement - Effective July 1, 2016 ............................................................. 38 Stelara® (Ustekinumab) Injection for Intravenous Infusion - Effective June 1, 2016 ................................................................................................ 41

Administrative Policy Updates

REVISED

Accreditation Requirements for Radiology Services - Effective July 1, 2016 ............................................................................................................ 43 Credentialing Guidelines: Participation in the eviCore healthcare Network - Effective July 1, 2016 ............................................................................ 45

Reimbursement Policy Updates

UPDATED

Durable Medical Equipment, Orthotics and Prosthetics Multiple Frequency - Effective May 1, 2016 ............................................................................ 48 Global Days - Effective May 16, 2016 ................................................................................................................................................................ 52 Maximum Frequency Per Day - Effective May 16, 2016 ........................................................................................................................................ 57 Procedure and Place of Service - Effective May 1, 2016 ....................................................................................................................................... 62

REVISED

Care Plan Oversight - Effective June 1, 2016 ...................................................................................................................................................... 63 Modifier SU - Effective June 1, 2016 ................................................................................................................................................................. 63

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In This Issue

New Patient Visit - Effective June 1, 2016 .......................................................................................................................................................... 64 One or More Sessions - Effective June 1, 2016 ................................................................................................................................................... 65 Supply Policy - Effective June 1, 2016 ............................................................................................................................................................... 66

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Clinical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Chelation Therapy for Non-Overload Conditions

May 1, 2016

Reformatted policy; transferred content to new template

Updated benefit considerations; added instruction to check the

member specific benefit plan

document and any federal or state mandates, if applicable, prior to using this policy

Updated supporting information to reflect the most current clinical evidence, FDA information, and

references

Chelation for heavy metal toxicity and overload conditions (e.g., iron, copper, lead, aluminum) is proven and medically necessary and not addressed in this policy.

Chelation therapy is unproven and not medically necessary for the

treatment of "mercury toxicity" from dental amalgam fillings. Randomized controlled trials do not identify a causal association between amalgam fillings and various systemic symptoms and disorders attributed to mercury. Chelation therapy is unproven and not medically necessary for the

treatment of chronic, progressive diseases (not involving heavy metal toxicity or overload conditions) and other disorders including but not limited to: Alzheimer's disease Apoplectic coma Autism spectrum disorder

Cancer Cardiovascular disease Cholelithiasis Chronic fatigue syndrom Chronic renal insufficiency Defective hearing Diabetes

Diabetic ulcer Gout Erectile dysfunction Multiple sclerosis Osteoarthritis

Osteoporosis Parkinson's disease

Raynaud's disease Renal calculus Rheumatoid arthritis Schizophrenia Scleroderma Snake venom poisonin

Varicose veins

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UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Chelation Therapy for Non-Overload Conditions (continued)

May 1, 2016 Vision disorders (glaucoma, cataracts, etc.) Much of the evidence supporting chelation treatment for other chronic progressive disease is based on testimonials and single-case studies. Thus, there still is no scientific evidence that demonstrates any benefit from this

form of therapy.

Chromosome Microarray Testing

Jun. 1, 2016

Reformatted policy; transferred content to new template

Added reference link to related policy titled Gene Expression Tests

Updated definition of “intellectual disability”

Reformatted list of applicable CPT codes; arranged codes in alphanumeric order

Updated list of applicable ICD-10

diagnosis codes; added Q93.3 Updated supporting information

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

Comparative genomic hybridization microarray testing or single nucleotide polymorphism (SNP) chromosomal microarray analysis is proven and medically necessary to evaluate an embryo/fetus in the following cases: Women undergoing invasive prenatal testing (i.e., amniocentesis,

chorionic villus sampling or fetal tissue sampling) Intrauterine fetal demise or stillbirth. Comparative genomic hybridization microarray testing or single nucleotide polymorphism (SNP) chromosomal microarray analysis is proven and medically necessary in the evaluation of patients with

one or more of the following: Multiple anomalies not specific to a well-delineated genetic syndrome and

cannot be identified by a clinical evaluation alone Non-syndromic developmental delay/intellectual disability Autism spectrum disorders. Comparative genomic hybridization microarray testing and single

nucleotide polymorphism (SNP) chromosomal microarray analysis are unproven and not medically necessary for all other patient populations and conditions including but not limited to the following: Preimplantation genetic diagnosis or screening in embryos Diagnosis, management, and prognosis of cancer.

There is insufficient evidence in the clinical literature demonstrating that

comparative genomic hybridization (CGH) microarray testing or single nucleotide polymorphism (SNP) chromosomal microarray analysis has a role in clinical decision-making or has a beneficial effect on health outcomes for other conditions such as preimplantation genetic diagnosis or screening in embryos or aiding diagnosis or tumor classification or determining the most appropriate treatment and establishing an accurate prognosis for cancer.

Further studies are needed to determine the analytic validity, clinical validity

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UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Chromosome Microarray Testing (continued)

Jun. 1, 2016 and clinical utility of this test for indications other than those listed above as proven/medically necessary. Genetic Counseling Genetic counseling is strongly recommended prior to this test in order to

inform persons being tested about the advantages and limitations of the test

as applied to a unique person.

Cochlear Implants May 1, 2016 Reformatted policy; transferred content to new template

Updated conditions of coverage; added notation to indicate:

o Oxford does not cover cochlear hybrid implants as they are not FDA approved and are considered experimental; refer to the policies titled Experimental/

Investigational Treatment and/or Experimental/ Investigational Treatment for NJ Plans

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

evidence, FDA information, and references

When used according to U.S. Food and Drug Administration (FDA) labeled indications, bilateral or unilateral cochlear implantation is proven and medically necessary for patients who meet all of the following criteria:

Diagnosis of bilateral prelingual or-postlingual moderate-to-profound sensorineural hearing impairment with limited benefit from appropriate hearing (or vibrotactile) aids;

Ability to follow or participate in a program of aural rehabilitation; Freedom from middle ear infection, an accessible cochlear lumen that is

structurally suited to implantation, and freedom from lesions in the

auditory nerve and acoustic areas of the central nervous system; No contraindications to surgery. See the U.S. Food and Drug Administration (FDA) section for FDA indications for each cochlear implant device. Specific criteria vary with the device. Cochlear hybrid implants are unproven and not medically necessary

for hearing loss. There is insufficient evidence in the clinical literature demonstrating the safety and efficacy of cochlear hybrid implants in the management of patients with severe hearing loss. Published evidence has shown that there is a potential risk of low frequency hearing loss as a result of cochlear hybrid

implant surgery. Studies are needed to verify that benefits are likely to outweigh the risks of cochlear hybrid implantation and to determine which

group of patients would benefit most from this device.

Collagen Crosslinks and Biochemical Markers of Bone Turnover

May 1, 2016

Reformatted policy; transferred content to new template

Updated supporting information to reflect the most current clinical

evidence and references; no

Serum or urine collagen crosslinks or biochemical markers are unproven and not medically necessary to assess risk of fracture, predict bone loss or assess response to antiresorptive therapy. There is insufficient evidence in the clinical literature that current methods

for measuring bone turnover markers are sufficiently sensitive to reliably

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UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Collagen Crosslinks and Biochemical Markers of Bone Turnover (continued)

May 1, 2016 change to coverage rationale or list of applicable codes

determine individual treatment responses. In addition, there is insufficient evidence from controlled studies that bone turnover marker measurement improves adherence to treatment or improves health outcomes such as reducing fracture rates.

Entyvio® (Vedolizumab)

Jun. 1, 2016

Reformatted coverage rationale Added list of applicable ICD-9

codes (discontinued Oct. 1,2015) Updated supporting information

to reflect the most current clinical evidence and references

Entyvio (vedolizumab) is proven and medically necessary for the treatment of: 1. Crohn's disease when all of the following criteria are met:

a. Diagnosis of moderately to severely active Crohn’s disease (CD); and

b. One of the following:

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

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

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

and c. Entyvio is initiated and titrated according to US Food and Drug

Administration labeled dosing for Crohn’s disease up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and

d. Patient is not receiving Entyvio in combination with either of the following: (1) Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab),

Cimzia (certolizumab)] (2) Tysabri (natalizumab)

2. Ulcerative colitis when all of the following criteria are met: a. Diagnosis of moderately to severely active ulcerative colitis (UC);

and b. One of the following:

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

(adalimumab), Simponi (golimumab)]

(b) Immunomodulator (e.g., azathioprine, 6-mercaptopurine)

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Clinical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Entyvio® (Vedolizumab) (continued)

Jun. 1, 2016 (c) Corticosteroid (2) Corticosteroid dependent (e.g., unable to successfully taper

corticosteroids without a return of the symptoms of UC) and

c. Entyvio is initiated and titrated according to US Food and Drug

Administration labeled dosing for ulcerative colitis up to a maximum

of 300mg every 8 weeks (or equivalent dose and interval schedule); and

d. Patient is not receiving Entyvio in combination with either of the following: (1) Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab),

Simponi (golimumab)]

(2) Tysabri (natalizumab)

Hearing Aids and Devices Including Wearable, Bone-Anchored and

Semi-Implantable

May 1, 2016

Reformatted policy; transferred content to new template

Updated supporting information to reflect the most current

description of services and references; no change to coverage rationale or lists of applicable codes

Wearable Hearing Aids (Including Non-Implantable Bone Conduction Hearing Aids Utilizing a Headband) Hearing aids required for the correction of a hearing impairment (a reduction in the ability to perceive sound which may range from

slight to complete deafness) are proven and medically necessary. Bilateral or unilateral bone-anchored hearing aids utilizing a headband (without osseointegration) are proven and medically necessary for hearing loss in a patient who is not a candidate for an air-conduction hearing aid and when used according to U.S. Food and Drug Administration (FDA) approved indications.

Semi-Implantable Electromagnetic Hearing Aids (SEHA) A semi-implantable electromagnetic hearing aid is proven and medically necessary for sensorineural hearing loss in a patient who is not a candidate for an air-conduction hearing aid and when used

according to FDA approved indications.

Bone Anchored Hearing Aids Implantable Bone-Anchored Hearing Aid (BAHA) for Sensorineural Hearing Loss: A unilateral implantable bone-anchored hearing aid is proven and medically necessary for sensorineural hearing loss in one ear in a

patient who is not a candidate for an air-conduction hearing aid and

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Policy Title Effective Date Summary of Changes Coverage Rationale

Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable

(continued)

May 1, 2016

when used according to FDA approved indications. Unilateral or bilateral implantable bone-anchored hearing aids are proven and medically necessary for sensorineural hearing loss in both ears when both of the following criteria are present:

The poorer ear is not a candidate for an air-conduction hearing aid due to

a speech reception threshold of 70 dB or more OR a word discrimination score of less than 60%; and

The better hearing ear has a speech reception threshold of 35 dB or less and a speech discrimination score of 60% or more.

Implantable Bone-Anchored Hearing Aid (BAHA) for Conductive or

Mixed Hearing Loss: A unilateral implantable bone-anchored hearing aid is proven and medically necessary for conductive or mixed hearing loss in one or both ears in a patient who is not a candidate for an air-conduction hearing aid and when used according to FDA approved indications.

Bilateral implantable bone-anchored hearing aids are proven and

medically necessary for conductive or mixed hearing loss in both ears in a patient who is not a candidate for an air-conduction hearing aid and when used according to FDA approved indications. Totally Implanted Hearing Systems Totally implanted hearing systems are unproven and not medically

necessary for hearing loss. There is inadequate evidence demonstrating the efficacy of totally implanted hearing systems for treating hearing loss or deafness. Well-designed studies with larger patient populations and longer follow-up are required to

demonstrate the safety and benefits of these devices. Partially Implantable Bone Conduction Hearing Aid With Magnetic

Coupling Partially implantable magnetic bone conduction hearing devices are unproven and not medically necessary for hearing loss. There is limited evidence to support the use of partially implantable magnetic bone conduction hearing devices to treat hearing loss. The evidence assessing the effectiveness of this device is limited to preliminary uncontrolled studies with small populations. Additional studies with larger

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Policy Title Effective Date Summary of Changes Coverage Rationale

Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable

(continued)

May 1, 2016

populations and long-term follow-up are needed to evaluate improvement of hearing with this device. Intraoral Bone Conduction Hearing Aids An intraoral bone conduction hearing aid is unproven and not

medically necessary for treating hearing loss.

There is insufficient evidence to support the use of an intraoral bone conduction hearing aid to treat hearing loss. The quality of the studies was low due to small study populations, short follow-up, and lack of randomization and appropriate control groups. Future studies with larger populations of patients wearing the device for longer periods are needed to evaluate hearing benefits and device safety.

Intermittent Intravenous Insulin Therapy

May 1, 2016 Reformatted policy; transferred content to new template

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

evidence, FDA information, and references; no change to coverage rationale or list of applicable codes

Intermittent intravenous insulin therapy (IIIT) is unproven and not medically necessary for reducing symptoms, improving glycemic control or preventing diabetic sequelae in patients with insulin dependent diabetes. There is insufficient evidence in the clinical literature demonstrating the

clinical utility of IIIT. The limited number of published studies lack adequate controls, randomization and blinding. Further studies, with larger sample sizes, are necessary to determine the health benefit of IIIT. Insulin potentiation therapy is unproven and not medically necessary for the treatment of cancer, infectious diseases, arthritis and other conditions.

There is inadequate evidence in the peer-reviewed, published clinical literature demonstrating that this therapy is safe and/or effective.

Orencia® (Abatacept) -

Injection for Intravenous

Infusion

Jun. 1, 2016

Updated benefit considerations; removed reference link to policy

titled Drug Coverage Guidelines for information pertaining to use

of Orencia (abatacept) subcutaneous formulation for treatment of rheumatoid arthritis

Updated list of applicable ICD-10 diagnosis codes; removed duplicate code listing for M08.80

Updated supporting information

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

1. Polyarticular juvenile idiopathic arthritis when all of the following criteria are met:

A. Diagnosis of moderate to severely active polyarticular juvenile idiopathic arthritis; and

B. Orencia is initiated and titrated according to US Food and Drug Administration labeled dosing for polyarticular juvenile idiopathic arthritis up to a maximum of (or equivalent dose and interval schedule):

1. 10mg/kg every 4 weeks for patients weighing <75kg

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Policy Title Effective Date Summary of Changes Coverage Rationale

Orencia® (Abatacept) - Injection for Intravenous Infusion

(continued)

Jun. 1, 2016 to reflect the most current background, clinical evidence and references

2. 1,000mg every 4 weeks for patients weighing ≥75kg and

C. Member is not receiving Orencia 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)] 2. Rheumatoid arthritis when all of the following criteria are met:

A. Diagnosis of moderately to severely active rheumatoid arthritis; and B. Orencia is initiated and titrated according to US Food and Drug

Administration labeled dosing for rheumatoid arthritis up to a

maximum of (or equivalent dose and interval schedule): 1. 500mg every 4 weeks for patients weighing <60kg 2. 750mg every 4 weeks for patients weighing 60kg to 100kg 3. 1,000mg every 4 weeks for patients weighing >100kg and

C. Member is not receiving Orencia 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)]

Orencia is unproven and not medically necessary for the treatment of:

1. Multiple sclerosis 2. Systemic lupus erythematosus 3. Graft versus host disease (GVHD) 4. Psoriatic arthropathy

5. Uveitis associated with Behçet's disease

Thermography

May 1, 2016

Reformatted policy; transferred

content to new template Added reference link to related

policy titled Abnormal Uterine Bleeding and Uterine Fibroids

Updated supporting information to reflect the most current clinical

evidence and references; no

Thermography (including digital infrared thermal imaging,

temperature gradient studies, and magnetic resonance (MR) thermography) is considered unproven or not medically necessary. There is insufficient evidence to conclude that thermography has a beneficial impact on health outcomes. The available evidence is limited and weak, and standards for image evaluation and cut-off values that would allow clinical recommendations based on this technology have not been established.

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UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Thermography (continued)

May 1, 2016 change to coverage rationale or list of applicable codes

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Actemra®

(Tocilizumab) Injection for Intravenous Infusion

Jun. 1, 2016

Revised coverage rationale:

o Added instruction to refer to the Oncology Medication Clinical Coverage Policy for updated information based upon the National Comprehensive Cancer

Network (NCCN) Drugs & Biologics Compendium®

(NCCN Compendium®) for oncology indications

o Updated coverage criteria for

treatment of polyarticular juvenile idiopathic arthritis

(PJIA) and rheumatoid arthritis (RA); added maximum dosing information

Added list of applicable ICD-9 codes (discontinued Oct. 1, 2015)

Updated supporting information

to reflect the most current clinical evidence and references

Please refer to Injectable Chemotherapy Drugs: Application of NCCN Clinical

Practice Guidelines for updated information based upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium®

(NCCN Compendium®) for oncology indications. This policy refers to Actemra (tocilizumab) injection for intravenous infusion.

Actemra is proven and medically necessary for the treatment of:

1. Polyarticular juvenile idiopathic arthritis when all of the following criteria are met: A. Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA) and

B. Actemra is initiated and titrated according to US Food and Drug Administration labeled dosing for polyarticular juvenile idiopathic

arthritis up to a maximum of (or equivalent dose and interval schedule): 1. 10mg/kg every 4 weeks for patients weighing < 30kg 2. 8mg/kg every 4 weeks for patients weighing ≥ 30kg and

C. Patient is not receiving Actemra 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)]

2. Rheumatoid arthritis when all of the following criteria are met:

A. Diagnosis of moderate to severely active rheumatoid arthritis (RA)

and B. History of failure, contraindication, or intolerance to at least one

non-biologic disease modifying anti-rheumatic drugs (DMARDs) [e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, minocycline, etc.] and

C. Actemra is initiated and titrated according to US Food and Drug

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Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Actemra®

(Tocilizumab) Injection for Intravenous Infusion

(continued)

Jun. 1, 2016 Administration labeled dosing for rheumatoid arthritis up to a maximum of 800mg every 4 weeks (or equivalent dose and interval schedule); and

D. Patient is not receiving Actemra 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)]

3. Systemic juvenile idiopathic arthritis when all of the following

criteria are met: A. Diagnosis of systemic juvenile idiopathic arthritis (SJIA) and

B. Actemra is initiated and titrated according to US Food and Drug Administration labeled dosing for systemic juvenile idiopathic arthritis up to a maximum of (or equivalent dose and interval schedule); 1. 12mg/kg every 2 weeks for patients weighing < 30kg 2. 8mg/kg every 2 weeks for patients weighing ≥ 30kg and

C. Patient is not receiving Actemra 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)]

Agents for

Migraine - Triptans

Jun. 1, 2016

Revised coverage rationale:

o Removed coverage guidelines and dosing information for Imitrex tablets

o Removed duplicative language detailing state

specific benefit coverage guidelines (see Benefit

Considerations section of policy for applicable details)

Alsuma*, Amerge, Axert, Frova, Imitrex Nasal Spray, Imitrex

Injection, Maxalt*, Maxalt-MLT*, Relpax, Sumavel DosePro, Treximet*, Zomig, Zomig-ZMT and Zomig Nasal Spray quantity requests exceeding the limited amount per copayment or coinsurance will be approved for up to the ceiling limit based on the following criteria: 1. Diagnosis of moderate to severe migraine headaches with or without

aura; and 2. One of the following:

a. Member has more than four migraines per month (provide number of migraines per month). Approval amount will only allow for treatment of the number of migraines per month the member experiences, up to the ceiling limit. The safety of treating an average of more than 4 headaches in a 30-day period has not been established; or

b. Member has more than two migraines per month each requiring

more than one dose (provide number of migraines per month).

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16 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Agents for Migraine - Triptans (continued)

Jun. 1, 2016

Approval amount will only allow for treatment of the number of migraines per month the member experiences, up to the ceiling limit;

and 3. Physician acknowledges that the potential benefit outweighs the risk

associated with the higher dose or quantity.

Triptan Ceiling Limits: Quantity Per Copayment

Drug Retail Home Delivery

Amerge 8 tablets 24 tablets

Axert 8 tablets 24 tablets

Frova 8 tablets 24 tablets

Imitrex Nasal Spray 2 packs (12 units) 6 packs (36 units)

Imitrex Injection 4mg and 6mg syringes, Alsuma* 6mg syringe

4 kits (8 injections) 12 kits (24 injections)

Imitrex Injection Vials 8 vials 24 vials

Maxalt*, Maxalt-MLT* 8 tablets 24 tablets

Relpax 8 tablets 24 tablets

Sumavel DosePro 8 units 24 units

Treximet* 9 tablets 27 tablets

Zomig, Zomig-ZMT 8 tablets 24 tablets

Zomig Nasal Spray 2 packs (12 units) 6 packs (36 units)

* Alsuma injection (brand), Maxalt (brand), Maxalt MLT (brand) and Treximet are non-preferred agents refer to the policy titled Drug Coverage Criteria -New and Therapeutic Equivalent Medications. Dosing Information:

Amerge

The recommended dose of Amerge is 1 mg or 2.5 mg. If the migraine returns or if the patient has only partial response, the dose may be repeated

once after 4 hours, for a maximum dose of 5 mg in a 24-hour period. The safety of treating an average of more than four migraine attacks in a 30 day period has not been established. Axert The recommended dose of Axert in adults and adolescents age 12 to 17

years is 6.25 mg to 12.5 mg, with the 12.5 mg dose tending to be a more

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17 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Agents for Migraine - Triptans (continued)

Jun. 1, 2016

effective dose in adults. As individuals may vary in their response to different doses of AXERT, the choice of dose should be made on an individual basis. If the headache returns, the dose may be repeated after 2 hours, but no more than two doses should be given within a 24-hour period. Controlled trials have not adequately established the effectiveness of a second dose if the

initial dose is ineffective. The safety of treating an average of more than four

migraine attacks in a 30-day period has not been established. Frova The recommended dose is a single tablet of Frova taken orally with fluids. If the headache recurs after initial relief, a second tablet may be taken, providing there is an interval of at least 2 hours between doses. The total

daily dose of Frova should not exceed 3 tablets (3 x 2.5mg per day). There is no evidence that a second dose of Frova is effective in patients who do not respond to a first dose of the drug for the same headache. The safety of treating an average of more than 4 migraine attacks in a 30-day period has not been established.

Imitrex Nasal Spray

The recommended adult dose of Imitrex for the acute treatment of migraine is 5 mg, 10 mg, or 20 mg. The 20-mg dose may provide a greater effect than the 5-mg and 10-mg doses, but may have a greater risk of adverse reactions. The 5-mg and 20-mg doses are given as a single spray in 1 nostril. The 10-mg dose may be achieved by the administration of a single 5-mg dose in each nostril. If the migraine has not resolved by 2 hours after

taking Imitrex, or returns after a transient improvement, 1 additional dose may be administered at least 2 hours after the first dose. The maximum daily dose is 40 mg in a 24-hour period. The safety of treating an average of more than four migraine attacks in a 30 day period has not been established.

Imitrex Injection The maximum single recommended adult dose of Imitrex Injection is 6 mg

injected subcutaneously. If side effects are dose limiting, then lower doses may be used (see Table 1). The maximum recommended dose that may be given in 24 hours is two 6-mg injections separated by at least 1 hour. Controlled clinical trials have failed to show that clear benefit is associated with the administration of a second 6-mg dose in patients who have failed to respond to a first injection. In patients receiving doses other than 4 or 6 mg, only the 6-mg single-dose vial dosage form should be used.

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18 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Agents for Migraine - Triptans (continued)

Jun. 1, 2016

Sumavel DosePro needle-free delivery system The maximum single recommended dose of Sumavel DosePro for the acute treatment of migraine or cluster headache is 6 mg given subcutaneously. For the treatment of migraine, if side effects are dose limiting, a lower dose (4 mg) may be used. For the treatment of cluster headache, the efficacy of a

lower dose has not been established. The maximum cumulative injected dose

that may be given in 24 hours is 12 mg, with doses of Sumavel DosePro separated by at least 1 hour. Sumavel DosePro may be given at least 1 hour following a dose of another sumatriptan product. A second dose should only be considered if some response to a first dose was observed. Maxalt, Maxalt-MLT

The recommended starting dose of Maxalt is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10 mg dose may provide a greater effect than the 5 mg dose, but may have a greater risk of adverse reactions. Although the effectiveness of a second dose or subsequent doses has not been established in placebo controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first

dose. The maximum daily dose should not exceed 30 mg in any 24-hour

period. The safety of treating, on average, more than four migraine attacks in a 30-day period has not been established. Relpax In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater proportion of

patients had a response following a 40 mg dose than following a 20 mg dose. The maximum recommended single dose is 40 mg. If after the initial dose, headache improves but then returns, a repeat dose may be beneficial. If a second dose is required, it should be taken at least 2 hours after the initial

dose. If the initial dose is ineffective, controlled clinical trials have not shown a benefit of a second dose to treat the same attack. The maximum daily dose should not exceed 80 mg. The safety of treating an average of more than 3

migraine headaches in a 30-day period has not been established. Zomig, Zomig-ZMT In controlled clinical trials, single doses of 1 mg, 2.5 mg and 5 mg of Zomig tablets were effective for the acute treatment of migraines in adults. A greater proportion of patients had headache response following a 2.5 mg or 5 mg dose than following a 1 mg dose. In the only direct comparison of 2.5

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19 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Agents for Migraine - Triptans (continued)

Jun. 1, 2016 mg and 5 mg, there was little added benefit from the larger dose but side effects are generally increased at 5 mg. Patients should, therefore, be started on 2.5 mg or lower. A dose lower than 2.5 mg can be achieved by manually breaking the scored 2.5 mg tablet in half. If the headache returns, the dose may be repeated after 2 hours, not to exceed 10 mg within a 24-

hour period. In a controlled clinical trial, a single dose of 2.5 mg of Zomig-

ZMT tablets was effective for the acute treatment of migraines in adults. If the headache returns, the dose may be repeated after 2 hours, not to exceed 10 mg within a 24-hour period. Controlled trials have not adequately established the effectiveness of a second dose if the initial dose is ineffective. The safety of treating an average of more than three headaches in a 30-day period has not been established.

Zomig Nasal Spray The recommended starting dose for Zomig nasal spray is 2.5 mg. The individual response may vary among individuals, so the dose should be adjusted accordingly. The maximum recommended single dose of Zomig is 5 mg. If the migraine has not resolved by 2 hours, or returns after transient

improvement, another dose may be administered. The maximum daily dose

should not exceed 10 mg in any 24-hour period. The effectiveness of a second dose has not been established in placebo-controlled trials. The safety of treating an average of more than four migraine attacks in a 30-day period has not been established. Treximet

Treximet is a fixed combination tablet containing sumatriptan 85 mg and naproxen sodium 500 mg. The recommended dose is 1 tablet. The efficacy of taking a second dose has not been established. The maximum daily dose should not exceed more than 2 Treximet tablets in 24 hours. Dosing of

tablets should be at least 2 hours apart. The safety of treating an average of more than 5 migraine headaches in a 30-day period has not been established.

Blepharoplasty, Blepharoptosis and Brow Ptosis Repair ‘

Jun. 1, 2016

Reformatted policy; transferred content to new template

Revised coverage rationale: o Updated coverage criteria for

treatment of ectropion

(eyelid turned outward) or

Indications for Coverage Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to the member specific benefit plan document.

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20 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Blepharoplasty, Blepharoptosis and Brow Ptosis Repair (continued)

Jun. 1, 2016

punctal eversion (CPT codes 67914 through 67917); removed criterion requiring trial and failure of conservative treatments

o Added language to indicate

repair of floppy eyelid syndrome (FES) (CPT codes 67961 and 67966) is considered reconstructive and medically necessary when all of the following are

present when documented and confirmed by history and examination: Subjective symptoms

must include eyelids spontaneously "flipping

over" when they sleep

due to rubbing on the pillow and one of the following: - Eye pain or

discomfort; or - Excess tearing; or

- Eye irritation, ocular redness and discharge

Physical Examination that

documents the following: - Eyelash Ptosis; and - Significant upper

eyelid laxity; and - Presence of Giant

Papillary Conjunctivitis; or

- Corneal findings such as: Superficial

Criteria for a Coverage Determination that Surgery is Reconstructive and Medically Necessary The following must be available when requested by UnitedHealthcare: Best corrected visual acuity in both eyes, all patients (except pediatrics). Eye exam (chief complaint, HPI)

Color photograph(s) (eye level, frontal with patient looking straight

ahead, light reflex visible and centered) Peripheral or superior visual fields automated, reliable (see Definitions),

un-taped/taped are preferable. Note the following: o In situations where computerized visual field testing is not available

we will accept manual visual field testing. o In situations where visual field testing is not possible, see section

below: “When Patient is Not Capable of Visual Field Testing”.

Note: The visual fields and color photograph(s) must be consistent.

If multiple procedures are requested, the following criteria must be met:

1. All criteria for each individual procedure must be met; and

2. Visual field testing shows visual impairment which can’t be addressed by one procedure alone; and

3. Color photograph findings are consistent with visual field findings.

A. Upper eyelid blepharoplasty (CPT 15822 and 15823) is considered reconstructive and medically necessary when the following criteria are present: 1. Ptosis has been ruled out as the primary cause of visual field

obstruction; and 2. The color photograph must show:

i. The extra skin, but not the lid margin, taped up to show it reverses the visual field obstruction; and/or

ii. Lateral hooding present; and 3. The patient must have a Functional/Physical Impairment complaint

directly related to an abnormality of the eyelid(s); and

4. Excess skin (dermatochalasis/blepharochalasis) touches the lashes; and

5. Automated peripheral or superior visual field testing, with the eyelids taped and un-taped, showing improvement of 30% or more in number of points seen. (In situations where computerized visual field testing is not

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21 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Blepharoplasty, Blepharoptosis and Brow Ptosis Repair (continued)

Jun. 1, 2016

Punctate Erosions (SPK); or

Corneal abrasion (Note: Documentation of

a history of

corneal abrasion or recurrent erosion syndrome is considered sufficient); or

Microbial Keratitis

Color photos that clearly document floppy eyelid syndrome; the photographs must clearly demonstrate both of the following:

- Lids must be everted

in the photos and - Conjunctival surface

(underbelly) of the lids must clearly demonstrate Giant Papillary

Conjunctivitis Documentation that

conservative treatment has been tried and failed;

examples may include: - Ocular lubricants

both drops (daytime)

and ointments (bedtime); or

- Short trial of antihistamines; or

- Topical steroid drops; or

- Eye Shield and/or

available we will accept manual visual field testing. In situations where visual field testing is not possible, see section

below, “When Patient is Not Capable of Visual Field Testing”.

Note: Extended blepharoplasty may be indicated for blepharospasm (eyelids are forced shut) when the following two criteria are met:

1. Debilitating symptoms (e.g., pain); and 2. Conservative treatment has been tried and failed, or is

contraindicated (e.g., Botox®)

B. Upper eyelid blepharoptosis repair (CPT 67901– 67909) is considered reconstructive and medically necessary when the

following criteria are present: 1. The patient must have a Functional/Physical Impairment complaint

directly related to the position of the eyelid(s); and 2. Other causes of ptosis are ruled out (e.g., recent botox injections,

myasthenia gravis when applicable); and 3. Eyelid droop (upper eyelid ptosis) and an MRD-1 of 2.0 mm or less;

and

4. The MRD is documented in color photographs with patient looking straight ahead and light reflex centered on the pupil; and

5. Automated peripheral or superior visual field testing, with the eyelids taped and un-taped, showing improvement of 30% or more improvement in the number of points seen. In situations where computerized visual field testing is not

available we will accept manual visual field testing. In situations where visual field testing is not possible, see section

below, “When Patient is Not Capable of Visual Field Testing”.

Note: For children under age 10 years, ptosis repair is covered to prevent amblyopia. Visual field testing is not required, but, a color

photograph is required.

C. Brow ptosis (CPT 67900) is considered reconstructive and medically necessary when the following criteria are present: 1. Other causes have been eliminated as the primary cause for the

visual field obstruction (e.g., Botox® treatments within the past six (6) months); and

2. Patient must have a functional complaint related to brow ptosis.

Brow ptosis must be documented in two color photographs. One

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22 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Blepharoplasty, Blepharoptosis and Brow Ptosis Repair (continued)

Jun. 1, 2016

Taping the lids at bedtime

Other causes of the eye findings have been ruled out; examples may

include:

- Allergic Conjunctivitis - Atopic

Keratoconjunctivitis - Blepharitis - Contact Lens (CL)

Complication

- Dermatochalasis - Ectropion - GPC (Giant Papillary

Conjunctivitis) that is not related to FES

- Ptosis of the lid(s)

- Superior Limbic

Keratoconjunctivitis (SLK)

Updated definitions; added definition of: o Floppy eyelid syndrome (FES) o Giant papillary conjunctivitis

Updated list of applicable CPT codes; added 67961 and 67966 (floppy eyelid syndrome)

showing the eyebrow below the bony superior orbital rim, and a second photograph with the brow taped up that eliminates the visual field defect; and Automated peripheral and superior visual field testing, with

differential taping (eyebrow and eyebrow + eyelid) showing 30%

or more improvement in total number of points seen with the

eyebrow taped up. In situations where computerized visual field testing is not available we will accept manual visual field testing.

In situations where visual field testing is not possible, see section below, “When Patient is Not Capable of Visual Field Testing”.

D. Eyelid surgery with an anophthalmic socket (has no eyeball) is considered reconstructive and medically necessary when both of the following criteria are present: 1. Patient has an anophthalmic condition; and

2. Patient is experiencing difficulties fitting or wearing an ocular prosthesis.

E. Lower eyelid blepharoplasty (CPT 15820 and 15821) is usually

cosmetic, however, is considered reconstructive and medically necessary only when all of the following criteria are present: 1. There is documented facial nerve damage; and 2. Color photograph documents the pathology; and 3. Patient is unable to close the eye due to the lower lid dysfunction;

and

4. Functional impairment including both of the following: Documented uncontrolled tearing or irritation; and Conservative treatments tried and failed.

F. Ectropion (eyelid turned outward) (CPT 67914 through 67917) or punctal eversion is considered reconstructive and medically

necessary when all of the following criteria are present: 1. Color photograph documents the pathology; and 2. Corneal or conjunctival injury with both of the following criteria:

Subjective symptoms include either:

a. Pain or discomfort; or b. Excess tearing; and

Any one of the following: a. Exposure keratitis; and/or b. Keratoconjunctivitis; and/or

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23 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Blepharoplasty, Blepharoptosis and Brow Ptosis Repair (continued)

Jun. 1, 2016

c. Corneal ulcer

G. Entropion (eyelid turned inward) (CPT 67921-67924) is considered reconstructive and medically necessary when all of the following criteria are present: 1. Color photograph must document the following:

Lid turned inward; and At least one of the following:

a. Trichiasis; or

b. Irritation of cornea or conjunctiva; and 2. Conservative treatments have been tried and failed; and 3. Subjective symptoms including either of the following:

Excessive tearing; or Pain or discomfort

H. Lid Retraction Surgery (CPT 67911) Lid retraction surgery is considered reconstructive and medically necessary when all of the following criteria are present:

1. Other causes have been eliminated as the reason for the lid

retraction such as use of dilating eye drops, glaucoma medications; and

2. Color photograph documents the pathology; and 3. There is functional impairment (such as ‘dry eyes’, pain/discomfort,

tearing, blurred vision); and 4. Tried and failed conservative treatments; and

5. In cases of thyroid eye disease two or more Hertel measurements at least 6 months apart with the same base measurements are unchanged.

I. Canthoplasty/Canthopexy (CPT 21280, 21282, 67950, 67961, 67966) is considered reconstructive and medically necessary

when all of the following criteria are present: 1. Functional impairment; and 2. Conservative treatments have been tried and failed; and 3. Color photograph documents the pathology; and

4. Simple repair of ectropion or entropion will not correct condition; and

5. At least one of the following patient complaints is present: Epiphora (excess tearing) not resolved by conservative

measures; or

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24 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Blepharoplasty, Blepharoptosis and Brow Ptosis Repair (continued)

Jun. 1, 2016

Corneal dryness unresponsive to lubricants; or Corneal ulcer

J. Repair of floppy eyelid syndrome (FES) (CPT 67961 and 67966) is

considered reconstructive and medically necessary when all of

the following are present when documented and confirmed by

history and examination: 1. Subjective symptoms must include eyelids spontaneously "flipping

over" when they sleep due to rubbing on the pillow, AND one of the following: Eye pain or discomfort; or Excess tearing; or

Eye irritation, ocular redness and discharge 2. Physical Examination that documents the following:

Eyelash Ptosis; and Significant upper eyelid laxity; and Presence of Giant Papillary Conjunctivitis OR

Corneal findings such as:

a) Superficial Punctate Erosions (SPK); or b) Corneal abrasion*; or c) Microbial Keratitis

*Note: Documentation of a history of corneal abrasion or recurrent

erosion syndrome is considered sufficient for the corneal findings requirement above.

3. Color photos that clearly document floppy eyelid syndrome. The photographs must clearly demonstrate both of the following: Lids must be everted in the photos and Conjunctival surface (underbelly) of the lids must clearly

demonstrate Giant Papillary Conjunctivitis

4. Documentation that conservative treatment has been tried and failed, examples may include: Ocular lubricants both drops (daytime) and ointments (bedtime);

or Short trial of antihistamines; or Topical steroid drops; or

Eye Shield and/or Taping the lids at bedtime 5. Other causes of the eye findings have been ruled out, examples may

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25 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Blepharoplasty, Blepharoptosis and Brow Ptosis Repair (continued)

Jun. 1, 2016 include: Allergic Conjunctivitis Atopic Keratoconjunctivitis Blepharitis Contact Lens (CL) Complication

Dermatochalasis

Ectropion GPC (Giant Papillary Conjunctivitis) that is not related to FES Ptosis of the lid(s) Superior Limbic Keratoconjunctivitis (SLK)

When Patient Is Not Capable of Visual Field Testing Visual field testing is not required when the patient is not capable of performing a visual field test. The following are some examples: If the patient is a child 12 years old or under

If the patient has intellectual disabilities (previously known as mental retardation) or some other severe neurologic disease

Coverage Limitations and Exclusions

Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to the member specific benefit plan document. Cosmetic Procedures are excluded from coverage: A. Procedures that correct an anatomical Congenital Anomaly without

improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or behavior) as a

reconstructive procedure. B. Any procedure that does not meet the reconstructive criteria above in

the Indications for Coverage section of the policy.

Cardiology Procedures Requiring Precertification for eviCore healthcare Arrangement

Jul. 1, 2016

Reformatted policy; transferred content to new template

Updated benefit considerations; added language for Essential Health Benefits for Individual and Small Group plans to indicate:

Oxford has engaged eviCore healthcare to perform initial reviews of requests for pre-certification (Oxford continues to be responsible for decisions to limit or deny coverage and for appeals). All pre-certification requests are handled by eviCore healthcare. To pre-certify a cardiology procedure, please contact eviCore healthcare via one of

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Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Cardiology Procedures Requiring Precertification for eviCore healthcare

Arrangement

(continued)

Jul. 1, 2016

o 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”)

o 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 coverage for benefits

which are deemed EHBs

(such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans

o 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 plan

document to determine benefit coverage

Revised coverage rationale/privileging and accreditation requirements: o Updated exception language

to indicate radiologists and

the three options below: Providers can call 1-877-PRE-AUTH (1-877-773-2884); or Providers can send a fax to 1-888-622-7369; or Providers can log onto the eviCore website at www.evicore.com

eviCore healthcare has established correct coding and evidence-based

criteria to determine the medical necessity and appropriate billing of cardiology services. These criterions have been carefully researched and are continually updated in order to be consistent with the most current evidence-based criteria. The cardiology evidence-based criteria and management criteria are

available on the eviCore healthcare website at www.evicore.com. Treating Cardiology providers may be asked to submit a clinical submission form. The following information/documentation may be required: Copies of office notes and treatment planning documents. Results of key diagnostic studies and/or office notes.

In conjunction with board certified cardiologists and radiologists, eviCore healthcare staff will evaluate the submitted treatment and billing plans. Providers will be informed, in writing, as to which services have been approved for payment. Where provided by state regulations, a board certified cardiologist will be

available to discuss the payment decision with the treating provider. Privileging and Accreditation Requirements Participating providers will be reimbursed for radiology and cardiology

services rendered in the office or in an outpatient setting. The following is a list of services that are payable to participating physicians based on their specialty as well as accreditation/certification requirements are required.

Precertification is required. Note: Hospitals are currently excluded from the privileging and accreditation requirements below. Exception: Radiologists and cardiologists who are currently participating in the Oxford network or wish to participate in the Oxford network and perform

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27 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Cardiology Procedures Requiring Precertification for eviCore healthcare

Arrangement

(continued)

Jul. 1, 2016

cardiologists who are currently participating in the Oxford network or wish to participate in the Oxford network and perform

Coronary CT Angiography

(CCTA) are required to complete a physician application from eviCore healthcare; removed language indicating a Professional Physician

Practice Assessment (PPPA) is required for hospitals and cardiologists who wish to perform Coronary CT Angiography (CCTA)

o Updated accreditation

requirements for participating

providers to perform cardiac services: Nuclear Medicine:

- Updated list of acceptable certifications ; added

“The Joint Commission (TJC)”

Cardiac CT, Cardiac PET and Cardiac MRI:

- Updated list of acceptable certifications ; added

“The Joint Commission (TJC)”

- Removed notation indicating a Professional Physician Practice Assessment (PPPA) is required for

Coronary CT Angiography (CCTA) are required to complete the physician application from eviCore healthcare. Documents can be sent to a provider upon request or obtained on the eviCore healthcare website at www.evicore.com.

Privileging requirement for participating providers to perform cardiac

services:

Modality Privileged

Nuclear Medicine, Cardiac CT Scan, PET and MRI

Radiologist Radiology center/facility Certified cardiologist Cardiovascular disease specialists

Diagnostic Cardiac Heart Catheterizations

Cardiovascular Disease Cardiology Group Pediatric cardiology Cardiology

Clinical Cardiac Electro physician

Cardiac Electrophysiology

Accreditation requirement for participating providers to perform cardiac services:

Modality Certification Required

Nuclear Medicine American Board of Radiology (ABR), American Board of Nuclear Medicine (ABNM), Certification Board of Nuclear Cardiology (CBNC), or The Joint Commission (TJC)

Cardiac CT Scan Cardiac PET Cardiac MRI

ACR (American College of Radiology), IAC (Intersocietal Accreditation Commission), or The Joint Commission (TJC)

Payment Guidelines Current Procedural Terminology (CPT) codes that are not subject to

TC/PC component may be reimbursed to both the physician and facility when billed for the same date of service (DOS).

ECG, diagnostic studies, and injection procedures must be billed in

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Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Cardiology Procedures Requiring Precertification for eviCore healthcare

Arrangement

(continued)

Jul. 1, 2016 radiology centers and hospitals who wish to perform Coronary CT Angiography (CCTA)

conjunction with an authorized cardiac catheterization code in order to be reimbursed on the same date of service. When billed in conjunction with an authorized cardiac catheterization, no separate authorization will be required in addition to the catheterization code for these services.

Clinical Trials

Jun. 1, 2016

Reformatted and revised benefit considerations: o Added instruction to check

the member specific benefit

plan document and any federal or state mandates, if applicable, prior to using this policy

o Removed content/language pertaining to product

exclusions, out-of-network benefits, and in-network exceptions for clinical trials

o Revised product specific guidelines for Connecticut (CT) plan members to indicate:

Official Request Form: All requests for coverage of a clinical trial must be submitted to Oxford on a specific form developed

by the Connecticut Department of Insurance

Provider Billing Restrictions: If the provider providing the routine patient costs is a non-network provider, Oxford will allow the non-

network provider the

Effective for plan years starting on or after January 1, 2014, the Patient Protection and Affordable Care Act (“PPACA”) requires non-grandfathered health plans to cover “Routine Patient Costs” incurred by a “Qualifying Individual” who is participating in an “Approved Clinical Trial”.

Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from participation in a qualifying clinical trial. Benefits are available only when the Member is clinically eligible for

participation in the qualifying clinical trial as defined by the researcher. I. APPROVED CLINICAL TRIAL

A. An “Approved Clinical Trial” is defined as: Phase I, Phase II, Phase III, or Phase IV clinical trial, Being conducted in relation to the prevention, detection or

treatment for Cancer or other life threatening disease or condition, and

That meets the requirements under Section II below. For purposes of this benefit, a “life-threatening disease or condition” is one from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

B. Additional Clinical Trials

The following clinical trials are not currently required by PPACA. However, these clinical trials are covered under Oxford’s clinical trial

benefit. Phase I, Phase II or Phase III clinical trial, Being conducted in relation to the detection or treatment of non-

life threatening: - Cardiovascular disease (cardiac/stroke), - Surgical musculoskeletal disorders of the spine, hip and

knees, and/or

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Clinical Policy Updates

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Policy Title Effective Date Summary of Changes Coverage Rationale

Clinical Trials (continued)

Jun. 1, 2016

lesser of: 1. Lowest per diem, fee

schedule rate or case rate as paid to any network provider in

the State of

Connecticut (that provides similar in-network services); or

2. Billed charges Participating and non-

participating CT providers

must accept payment as payment in full, and may not balance bill the member

Members are subject to balance billing by non-

participating, out-of-state

providers Updated coverage rationale;

added language to clarify benefits for clinical trials do not include the listed coverage limitations and exclusions

Updated definitions; removed CT product specific definition of “approved clinical trial” and “experimental or investigational

service(s)” Removed description of services

addressed in the policy

- Other Clinical Trials: Certain plans may allow clinical trials relating to other diseases or disorders which are not life-threatening. Please refer to the enrollee’s plan-specific SPD for coverage

That meets the requirements under Section II below.

II. CRITERIA FOR APPROVED CLINICAL TRIALS A. The clinical trial must be described in paragraph 1, 2 or 3 below.

1. The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following: - National Institutes of Health (NIH). (Includes National Cancer

Institute (NCI).) - Centers for Disease Control and Prevention (CDC). - Agency for Healthcare Research and Quality (AHRQ). - Centers for Medicare and Medicaid Services (CMS). - A cooperative group or center of any of the entities described

above or the Department of Defense (DOD) or the Veterans

Administration (VA).

- A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.

- The Department of Veterans Affairs, the Department of Defense or the Department of Energy as long as the study or investigation has been reviewed and approved through a

system of peer review that is determined by the Secretary of Health and Human Services to meet both of the following criteria: Comparable to the system of peer review of studies and

investigations used by the National Institutes of Health. Ensures unbiased review of the highest scientific

standards by qualified individuals who have no interest in

the outcome of the review. or

2. The study or investigation is conducted under an investigational new drug application reviewed by the U.S. Food and Drug Administration; or

3. The study or investigation is a drug trial that is exempt from having such an investigational new drug application.

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Clinical Policy Updates

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Policy Title Effective Date Summary of Changes Coverage Rationale

Clinical Trials (continued)

Jun. 1, 2016

B. Additional Requirements 1. The clinical trial must have a written protocol that describes a

scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled in the trial. We may, at any time, request documentation about

the trial.

2. The subject or purpose of the trial must be the evaluation of an item or service that meets the definition of a Covered Health Service and is not otherwise excluded under the Policy.

III.QUALIFIED INDIVIDUAL

A. To be a qualified individual an individual must be:

1. Covered under the health plan, and 2. Eligible to participate in an approved clinical trial according to the

trial protocol based upon: - The individual was referred to the clinical trial by an in-

network health care professional who has concluded that the individual's participation would be appropriate because the

individual is eligible for the trial according to its protocol, or

- The individual provides the plan with medical and scientific information that establishes that participation would be appropriate because the individual is eligible for the trial according to its protocol.

IV. ROUTINE PATIENT COSTS DURING CLINICAL TRIALS INCLUDE:

A. Covered Health Services for which Benefits are typically provided absent a clinical trial.

B. Covered Health Services required solely for: 1. The provision of the Experimental or Investigational service(s) or

item (e.g., the infusion administration services to deliver an investigational drug), and/or

2. The clinically appropriate monitoring of the effects of the service

or item (e.g., lab tests and imaging done at a frequency consistent with signs and symptoms and other standards of care for that diagnosis or treatment type), and/or

3. The prevention of complications. C. Covered Health Services needed for reasonable and necessary care

arising from the provision of an Experimental or Investigational service(s) item.

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Clinical Policy Updates

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Policy Title Effective Date Summary of Changes Coverage Rationale

Clinical Trials (continued)

Jun. 1, 2016

Network Plans: If one or more network providers are participating in a clinical trial, then Oxford may require that the Qualified Individual participate in the clinical

trial using a network provider, as long as the network provider will accept the qualifying individual as a participant in the trial. However, if

an Approved Clinical Trial is conducted outside of the Qualified Individual’s state of residence, then Oxford may not deny or otherwise limit payment for Routine Patient Services solely on the basis that the trial is conducted out-of-state.

COVERAGE LIMITATIONS AND EXCLUSIONS Benefits for clinical trials do not include: A. The Experimental or Investigational Service(s) or item that is used in the

clinical trial is not covered, except for the following: 1. Certain Category B devices (see definition)

2. Certain promising interventions for patients with terminal illnesses.

3. Other items and services that, in our determination, meet specified criteria in accordance with our medical and drug policies.

B. Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient. Examples include, but are not limited to: o Laboratory tests and imaging studies done at a frequency dictated by

the study protocol and not consistent with signs and symptoms and other standards of care for that diagnosis or treatment type.

C. A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

D. Items and services provided by the research sponsors free of charge for any person enrolled in the trial.

E. Travel and transportation expenses are excluded from coverage. These include, but are not limited to, the following examples: 1. Fees for all types of transportation. Examples include, but are not

limited to: personal vehicle, taxi, medical van, ambulance, commercial airline, and train.

2. Rental car expenses. 3. Mileage reimbursement for driving a personal vehicle.

4. Lodging. 5. Meals.

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32 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Clinical Trials (continued)

Jun. 1, 2016 F. Routine patient costs obtained out-of-network where non-network benefits do not exist under the plan.

G. Clinical Trials that do not meet the requirements listed in the Indications for Coverage section above. An example includes, but is not limited to, Phase 0 drug clinical trials.

Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Jun. 1, 2016 Revised list of medications requiring precertification through the pharmacy benefit manager (PBM); added Adzenys XR, Alogliptin (Nesina Authorized Generic), Alogliptin/Metformin

(Kazano Authorized Generic), Alogliptin/Pioglitazone (Oseni Authorized Generic), Descovy, Emverm, Idelvion, Kovaltry, Semivo spray, Taltz and Zembrace

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

REVISED

Policy Title Effective Date Drug/Medication Status Summary of Changes

Drug Coverage Guidelines

Jun. 1, 2016

Revised prior authorization/notification guidelines for recent FDA-approved drug products for which drug-specific criteria are unavailable; refer to Prior Authorization/Notification Guidelines: Interim New Product Coverage Criteria for complete details

Actemra (Tocilizumab):

SQ Injection

Revised Revised prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Actemra for complete details Updated step therapy guidelines; refer to Step Therapy Guidelines:

Actemra for complete details

Addyi (Flibanserin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Addyi for complete details

Adzenys XR (Amphetamine Extended-Release

New Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM)

o Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Alogliptin (Nesina Authorized Generic)

New

Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

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33 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Drug/Medication Status Summary of Changes

Drug Coverage Guidelines (continued)

Jun. 1, 2016

Alogliptin (Nesina Authorized Generic) (continued)

New Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines; refer to Therapeutic

Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Alogliptin/Metformin (Kazano Authorized

Generic)

New Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines; refer to Therapeutic

Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Alogliptin/Pioglitazone (Oseni Authorized Generic)

New Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines; refer to Therapeutic

Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Cimzia (Certolizumab

Pegol)

Revised Revised prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Cimzia (Certolizumab Pegol) for complete details

Cosentyx (Secukinumab) Revised Revised prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Cosentyx for complete details Revised step therapy guidelines; refer to Step Therapy Guidelines:

Cosentyx for complete details

Diclegis (Doxylamine

Succinate and Pyridoxine Hydrochloride)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Diclegis for complete details

Diclofenac 1% Topical Gel (Generic Voltaren)

New Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM)

o Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Emverm (Mebendazole) New Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM)

o Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

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34 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Drug/Medication Status Summary of Changes

Drug Coverage Guidelines (continued)

Jun. 1, 2016

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

Updated step therapy guidelines; refer to Step Therapy Guidelines: Enbrel for complete details

Glumetza (Metformin

Extended-Release)

Updated Updated prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Glumetza (Metformin Extended-Release) for complete details

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

Idelvion (Coagulation Factor IX

(Recombinant), Albumin Fusion Protein)

New Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines; refer to Therapeutic

Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Imitrex (Sumatriptan)

(Brand Only)

Revised Revised coverage criteria/precertification requirements; removed

reference link to policy titled Precertification Guidelines: Agents for Migraine - Triptans

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

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

Orencia (Abatacept): SQ

Injection

Revised Revised prior authorization/notification guidelines; refer to Prior

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

Orencia for complete details

Otezla (Apremilast) Revised Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Otezla (Apremilast) for complete details

Revised step therapy guidelines; refer to Step Therapy Guidelines:

Otezla for complete details

Peg-Intron (Peginterferon Alfa-2b)

Revised Revised coverage criteria/precertification requirements; removed reference link to policy titled Step Therapy Guidelines: PegIntron (peginterferon alfa-2b)

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35 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Drug/Medication Status Summary of Changes

Drug Coverage Guidelines (continued)

Jun. 1, 2016

Rescula (Unoprostone) Updated Updated step therapy guidelines; refer to Step Therapy Guidelines: Rescula for complete details

Restasis (Cyclosporine Ophthalmic Emulsion)

Revised Revised prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Restasis (Cyclosporine Ophthalmic Emulsion) for complete details

Sernivo Spray (Betamethasone

Dipropionate)

New Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines; refer to Therapeutic

Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Simponi (Golimumab) Revised Revised prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Simponi (Golimumab) for complete details

Stelara (Ustekinumab) Revised Revised prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Stelara (Ustekinumab) Injection for Intravenous Use for complete details

Taltz (Ixekizumab) New Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines; refer to Therapeutic

Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Travoprost (Generic

Travatan)

Updated Updated step therapy guidelines; refer to Step Therapy Guidelines:

Travoprost (Generic Travatan) for complete details

Vecamyl (Mecamylamine)

Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Vecamyl (Mecamylamine) for

complete details

Xeljanz XR Revised Revised coverage criteria/precertification requirements; added prior

authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Xeljanz XR for complete details

Zegerid Suspension

(Omeprazole/Sodium Bicarbonate)

Revised Revised prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Non-Solid Oral Dosage Forms for complete details

Zembrace (Sumatriptan Succinate)

New

Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM)

o Added therapeutic equivalent guidelines; refer to Therapeutic

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36 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Drug/Medication Status Summary of Changes

Drug Coverage Guidelines (continued)

Jun. 1, 2016 Zembrace (Sumatriptan Succinate) (continued)

New Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Zioptan (Tafluprost) Updated Updated step therapy guidelines; refer to Step Therapy Guidelines:

Zioptan (Tafluprost) for complete details

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Omnibus Codes Jun. 1, 2016 Reformatted policy; transferred content to new template

Revised coverage rationale for

skin substitutes/wound care management; added language to indicate PuraPly™ and PuraPly™ Antimicrobial (HCPCS code C9349) are unproven/not medically necessary

Updated supporting information

to reflect the most current clinical evidence and references

Refer to the policy for complete details on the coverage guidelines for Omnibus Codes.

Oxford's Outpatient Imaging Self-Referral

Jul. 1, 2016

Reformatted policy; transferred content to new template

Added benefit considerations

language for Essential Health Benefits for Individual and Small Group plans to indicate: o 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”)

o Large group plans (both self-

funded and fully insured),

Refer to the policy for complete details on Oxford's Outpatient Imaging Self-Referral.

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37 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Oxford's Outpatient Imaging Self-Referral (continued)

Jul. 1, 2016 and small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to

provide coverage for benefits

which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all Grandfathered and Non-

Grandfathered plans o 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 plan document to determine benefit coverage

Revised coverage rationale for Cardiologists - Nuclear Medicine and Cardiologists -

Pediatric only to indicate laboratories performing nuclear studies must be accredited by the Intersocietal Commission for the

Accreditation of Nuclear Laboratories (ICANL), the American College of Radiology

(ACR), or The Joint Commission (TJC)

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38 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Radiology Procedures Requiring Precertification for eviCore healthcare

Arrangement

Jul. 1, 2016

Reformatted policy; transferred content to new template

Added benefit considerations language for Essential Health Benefits for Individual and Small

Group plans to indicate:

o 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”)

o 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 coverage for benefits which are deemed EHBs

(such as maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all

Grandfathered and Non-Grandfathered plans

o 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 plan document to determine

Refer to the policy for complete details on Radiology Procedures Requiring Precertification for eviCore healthcare Arrangement.

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39 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Radiology Procedures Requiring Precertification for eviCore healthcare

Arrangement

(continued)

Jul. 1, 2016

benefit coverage Revised coverage

rationale/accreditation requirements for participating providers:

o Removed exception language

indicating a Professional Physician Practice Assessment (PPPA) is required for hospitals who wish to perform Coronary CT Angiography (CCTA)

o MRI, PET and CT Studies: Updated language to

indicate MRI, PET and CT studies must be performed on an American College of

Radiology (ACR),

Intersocietal Accreditation Commission (IAC), RadSite, or The Joint Commission (TJC) accredited unit or at accredited facilities

o Nuclear Medicine Procedures: Updated list of acceptable

accreditations for facilities [for

reimbursement of procedure codes noted with an asterisk (*)];

added: - Intersocietal

Accreditation Commission (IAC)

Updated list of acceptable certifications for radiologists and

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40 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Radiology Procedures Requiring Precertification for eviCore healthcare

Arrangement

(continued)

Jul. 1, 2016 cardiologists [for reimbursement of procedure codes noted with an asterisk (*)]; added:

- American Osteopathic

Board of radiology (AOBR)

- American Osteopathic Board of Nuclear Medicine (AOBNM)

- American Board of

Internal Medicine Updated list of applicable CPT

codes; removed 72202, 76070, 76075, 76830, 78110, 78111, 78120, 78121, 78122, 78130, 78135, 78140, 78190, 78191,

78220, 78223, 78270, 78271,

78272, 78350, 78351, 78584, 78585, 78586, 78587, 78588, 78591, 78593, 78594, 78594, G0030, G0031, G0032, G0033, G0034, G0035, G0036, G0037, G0038, G0039, G0040, G0041,

G0042, G0043, G0044, G0045, G0046, G0047, G0125, G0210, G0211, G0212, G0213, G0214, G0215, G0216, G0217, G0218,

G0219, G0220, G0221, G0222, G0223, G0224, G0226, G0227, G0228, G0229, G0230, G0231,

G0232, G0233, G0234, G0253 and G0254

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41 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Stelara®

(Ustekinumab) Injection for Intravenous Infusion

Jun. 1, 2016

Removed reference links to policies titled: o Orencia (Abatacept):

Intravenous Infusion o Prescription Drug Quantity

Duration (QD) and Quantity

Level Limitations (QLL) o Rituxan (Rituximab)

Revised coverage criteria for treatment of plaque psoriasis and psoriatic arthritis; added language to indicate Stelara is

not proven/medically necessary for use in combination with phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

Updated supporting information

to reflect the most current

background, clinical evidence, FDA information and references

This policy refers to Stelara (ustekinumab) injection for intravenous infusion. Stelara is proven and medically necessary for the treatment of: 1. Plaque psoriasis when all of the following criteria are met:

A. Diagnosis of moderate to severe plaque psoriasis; and

B. One of the following:

1) Patient is a candidate for phototherapy 2) Patient is a candidate for systemic therapy and

C. Stelara is initiated and titrated according to US Food and Drug Administration labeled dosing for plaque psoriasis up to a maximum of (or equivalent dose and interval schedule):

1) 45mg every 12 weeks for patients weighing ≤100kg 2) 90mg every 12 weeks for patients weighing >100kg and

D. Patient is not receiving Stelara 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)]

3) Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] 2. Psoriatic arthritis when all of the following criteria are met:

A. Diagnosis of psoriatic arthritis; and B. Stelara is initiated and titrated according to US Food and Drug

Administration labeled dosing for psoriatic arthritis up to a maximum of 90mg every 12 weeks (or equivalent dose and interval schedule); and

C. Patient is not receiving Stelara 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)]

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

Stelara is unproven and not medically necessary for the treatment of: Crohn’s disease Multiple sclerosis

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42 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Clinical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Stelara® (Ustekinumab) Injection for Intravenous Infusion

(continued)

Jun. 1, 2016 The findings of available studies are limited by short duration and/or relatively small patient population. Larger and longer term phase III studies are needed to further characterize ustekinumab efficacy and safety for treatment of Crohn’s disease.

In available studies, ustekinumab does not demonstrate efficacy in the

treatment of multiple sclerosis.

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43 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Administrative Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Administrative Guidelines

Accreditation Requirements for Radiology Services

Jul. 1, 2016

Changed policy title; previously titled Accreditation Requirements For Radiologists and Radiology Centers

Reformatted policy; transferred content to new template

Updated policy overview to indicate the purpose of this policy is to outline the process and accreditation requirements for radiologists, radiology centers

and multi-speciality provider groups interested in participating in the Oxford network; removed content/language specific to credentialingrequirements

Updated definitions:

o Added definition of:

TJC - The Joint Commission

o Removed defintion of: ABR - American Board of

Radiology ABNM - American Board

of Nuclear Medicine CBNC - Certification

Board of Nuclear Cardiology (CBNC) [formerly known as the

Certification Council of Nuclear Cardiology

(CCNC)] CCTA - Coronary CT

Angiography CT-PPPA - Coronary CT

Angiography & Cardiac CT Professional Physician Practice Assessment

ICANL - The Intersocietal

In diagnostic imaging, accreditation programs have emerged as key initiatives to advance the quality and safety of imaging studies. It is important that Members receive services from facilities whose equipment, technologists, and physicians are in compliance with established

accreditation performance standards.

All freestanding facilities and physician offices performing outpatient radiology imaging studies are required to obtain and maintain accreditation as a condition for reimbursement for the below services.

Provider Specialty

Accreditation Modality/Procedure

Radiologist, Radiology Facilities, and

Multi-Specialty Provider

Groups

ACR MRI, Breast MRI, CT, *Nuclear Medicine, PET, Ultrasound, Breast Ultrasound, Mammography,

Stereotactic Biopsy

AIUM MRI, CT, *Nuclear Medicine, PET,

Ultrasound (vascular), Echocardiography

ASBS MRI, CT, *Nuclear Medicine, PET,

Ultrasound, X-ray

IAC MRI, CT, *Nuclear Medicine (SPECT), PET

RadSite (except

cardiac procedures)

Ultrasound

TJC Breast Ultrasound, Stereotactic Breast Biopsy

Note: *Nuclear Medicine procedures noted with an * are only reimbursable to radiologists when they have the appropriate certification.

Please see Radiology Procedures Requiring Precertification for eviCore healthcare Arrangement for applicable CPT codes.

Oxford has engaged eviCore healthcare to manage the accreditation process for our provider network. Accreditations should be faxed to eviCore healthcare at 866-699-8160 with the Accreditation Fax Cover sheet that can

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44 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Administrative Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Administrative Guidelines

Accreditation Requirements for Radiology Services (continued)

Jul. 1, 2016

Commission for the Accreditation of Nuclear Medicine Laboratories

Revised accreditation requirements for radiologists,

radiology centers and multi-

speciality provider groups to indicate all freestanding facilities and physician offices performing outpatient radiology imaging studies are required to obtain and maintain accreditation as a

condition for reimbursement for the below services:

Accred-itation

Modality/ Procedure

ACR MRI, Breast MRI,

CT, *Nuclear Medicine, PET, Ultrasound, Breast Ultrasound, Mammography,

Stereotactic Biopsy

AIUM MRI, CT, *Nuclear Medicine, PET, Ultrasound

(vascular), Echocardio-graphy

ASBS MRI, CT, *Nuclear

Medicine, PET, Ultrasound, X-ray

be found on the eviCore healthcare website at www.evicore.com. To ensure prompt handling of the accreditation please ensure that all applicable facility and physician information is included.

If you have specific questions about the application process for accreditation,

contact the ACR or IAC on their websites or by phone. For questions about Oxford’s accreditation requirements, call 1-800-666-1353. In addition to accreditation, all radiologists and radiology centers in New York (NY) and New Jersey (NJ), who are interested in participating in the Oxford network and/or radiologists and radiology centers that already participate in

the Oxford network and want to add a modality to their practice must also be credentialed. Please refer to the policy titled Credentialing Guidelines: Participation in the eviCore healthcare Network for additional information.

Exception: Radiologists and radiology centers performing outpatient radiology

imaging studies in Connecticut (CT) are excluded from credentialing

requirements (accreditation requirements are applicable). Hospitals performing outpatient radiology imaging studies are excluded

from the accreditation requirements. All radiologists, radiology centers, and cardiologists in NY, NJ and CT who are currently participating in the Oxford network or wish to participate in the

Oxford network and perform Coronary CT Angiography (CCTA) must also be credentialed. Refer to the policy titled Credentialing Guidelines: Participation in the eviCore healthcare Network for additional information.

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45 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Administrative Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Administrative Guidelines

Accreditation Requirements for Radiology Services (continued)

Jul. 1, 2016 IAC MRI, CT, *Nuclear Medicine (SPECT), PET

RadSite (except

cardiac procedures)

Ultrasound

TJC Breast

Ultrasound, Stereotactic Breast Biopsy

*Nuclear Medicine procedures are only reimbursable to

radiologists when they have the appropriate certification.

Credentialing

Guidelines: Participation in the eviCore healthcare

Network

Jul. 1, 2016

Reformatted policy; transferred

content to new template Revised process and credentialing

guidelines for radiologists and

cardiologists interested in participating in the eviCore Healthcare Network for Oxford o Updated reference link to

eviCore.com for information on minimum standards to participate in the Oxford

network

o Updated credentialing request guidelines: Removed language

indicating current or new Oxford providers in NY,

NJ and CT performing Coronary CT Angiography (CCTA) are required to complete the Coronary CT Angiography &

Oxford has engaged eviCore healthcare (eviCore) to perform Credentialing as

well as Quality and Equipment review of Outpatient Diagnostic Radiology Centers who participate or wish to participate in the Oxford network.

The minimum standards for consideration into the Oxford network can be found at http://www.evicore.com/solution/Pages/Radiology.aspx.

Radiology centers in New York (NY) and New Jersey (NJ) who are interested in participating in the Oxford network and radiology centers that already participate in the Oxford network and want to add a modality to their practice are required to email the eviCore Provider Contracting Services

(PCS) Department at [email protected] stating the nature of the request along with the name, address and contact email for facility. Credentials to

access the online Facility Application will then be forwarded to the requestor via email.

Exception: Radiology centers performing outpatient radiology imaging studies in Connecticut (CT) are excluded from the above credentialing requirements.

Interpreting radiologists at facilities that are applying for a contract who are not currently credentialed by eviCore will need to complete a Physician Application and complete the physician credentialing process.

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46 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Administrative Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Administrative Guidelines

Credentialing Guidelines: Participation in the eviCore healthcare Network

(continued)

Jul. 1, 2016

Cardiac CT Professional Physician Practice Assessment (CT-PPPA) from eviCore Healthcare

Added language to

indicate:

- Radiology centers in New York (NY) and New Jersey (NJ) who are interested in participating in the Oxford network and

radiology centers that already participate in the Oxford network and want to add a modality to their practice are required

to email the eviCore

Provider Contracting Services (PCS) Department at [email protected] stating the nature of the request along

with the name, address and contact email for facility; credentials to access

the online Facility Application will then be forwarded to the

requestor via email

- Interpreting radiologists at facilities that are applying for a contract who are not currently credentialed

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47 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Administrative Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Administrative Guidelines

Credentialing Guidelines: Participation in the eviCore healthcare Network

(continued)

Jul. 1, 2016 by eviCore will need to complete a Physician Application and complete the physician

credentialing process

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48 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Reimbursement Policy Updates \

UPDATED

Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Durable Medical Equipment, Orthotics and Prosthetics Multiple Frequency

May 1, 2016

Reformatted policy; transferred content to new template

Updated list of Items Eligible for Rental or Purchase (attachment file listing HCPCS codes for

items that may be eligible for

rental or purchase when reported with an appropriate modifier) to reflect quarterly code edits (effective May 1, 2016):

o Added E0466, E0639, E0640 and E1012

o Removed E0450, E0460, E0461, E0463 and E0464 (deleted codes effective Jan. 1, 2016)

Rental and Purchase Modifiers Some DME items are eligible for rental as well as for purchase. The codes representing these items are listed in Items Eligible for Rental or Purchase in the Attachments section of this policy and must be reported with the appropriate rental or purchase modifier in order to be considered for

reimbursement.

Some DME items are eligible for rental only. The codes representing these items are listed in Items Eligible for Rental Only in the Attachments section of this policy and must be reported with the appropriate rental modifier in order to be considered for reimbursement.

Rental guidelines are explained further in the sections titled Monthly Rental and Daily Rental. Rental Modifiers The following modifiers indicate that an item has been rented:

RR - Rental

KH - Initial Claim, purchase or first month rental KI - Second or third monthly rental KJ - Capped rental months four to fourteen 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, Hospital, Ambulatory Surgical Center 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 (please see the definitions section of this

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Durable Medical Equipment, Orthotics and Prosthetics Multiple Frequency

(continued)

May 1, 2016

policy) 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 Hospital, Ambulatory Surgical Center 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 codes with a rental modifier when both modifiers RT and LT are submitted for the same HCPCS code on separate lines. Modifiers RT and LT may be used to

report an item for the right or left side of the body. Use of these modifiers may convey that multiples of that item are being utilized. Backup Ventilator One additional rental rate will be allowed in the same Calendar Month for a backup ventilator reported with a rental modifier plus modifier TW (backup

equipment), appended to HCPCS codes E0465 and E0466.

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. For additional information, refer to the Questions and Answers section, and

the Attachments section of this policy. 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

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Reimbursement Policy Updates

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Durable Medical Equipment, Orthotics and Prosthetics Multiple Frequency

(continued)

May 1, 2016

"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

E1130-RR reported with 3 units, a From Date of 1/10/2013 and a To Date of 4/9/2013 on one line will result in reimbursement of only 1 unit. Daily Rental Oxford will allow a daily rental for the following items to the Same Specialty Physician, Hospital, Ambulatory Surgical Center 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

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51 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Reimbursement Policy Updates

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Durable Medical Equipment, Orthotics and Prosthetics Multiple Frequency

(continued)

May 1, 2016 Maintenance and Service Fees Oxford allows for reimbursement of maintenance and service once every six months to the Same Specialty Physician Hospital, Ambulatory Surgical Center 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

maintain the warranty or performance standards

Re-education Compliance with alerts and recalls Necessary supplies in accordance with the applicable agreement Back-up equipment 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

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52 UnitedHealthcare® Oxford Policy Update Bulletin: May 2016

Reimbursement Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Global Days

May 16, 2016

Updated Global Days Assignment list (attachment file listing CPT/HCPCS codes and their global days value assignments) to reflect quarterly

code edits (effective May 16,

2016): o Added 10030 with global day

value “000” o Removed 73060 and 73560

Updated list of EM Services Included in the Global Period

(attachment file listing evaluation and management services included in the global period) to reflect quarterly code edits (effective May 16, 2016); added G9481, G9482, G9483,

G9484, G9485, G9486, G9487,

G9488, G9489 and G9490

Global Period Assignments and Global Package Oxford follows the Centers for Medicare and Medicaid Services (CMS) in regard to Global Days Values as set forth in the National Physician Fee Schedule (NPFS) Relative Value File, except as noted below. Oxford also follows CMS in regard to services included in and excluded from the Global Surgical Package.

Refer to: Global Days Assignment List

CMS/NPFS Global Value

Oxford Global Days Value Value Description

000 000

Endoscopic or minor procedure with related preoperative and postoperative

relative values on the day of the procedure only are included in the Global Surgical Package. Evaluation and Management (E/M) services on the day of the procedure are not reimbursable except as noted within this policy.

010 010

Minor procedure with preoperative relative

values on the day of the procedure and postoperative relative values during a 10-day postoperative period are included in the Global Surgical Package. Evaluation and Management services on the day of the procedure and during the 10-day

postoperative period are not reimbursable except as noted within this policy. A procedure having a Global Days Value of 000, 010 or 090 that is performed during the postoperative period of a procedure

having a Global Days Value of 010 is

included in the Global Surgical Package of the initial procedure and is not separately reimbursable except as noted within this policy.

090 090

Major procedures with a 1-day preoperative period and 90-day postoperative period

included in the Global Surgical Package. Evaluation and Management services on the day prior to the procedure, the day of the

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Reimbursement Policy Updates

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Global Days (continued)

May 16, 2016

procedure, and during the 90-day postoperative period are not reimbursable except as noted within this policy. A procedures having a Global Days Value of

000, 010 or 090 that is performed during the postoperative period of a procedure having a

Global Days Value of 090 is included in the Global Surgical Package of the initial procedure and is not separately reimbursable except as noted within this policy.

MMM 000, 042,

XXX

Maternity code; the usual Global Period concept does not apply. Oxford assigns Global Days Values to these codes. Codes which represent delivery plus postpartum services are assigned a Global Days Value of 042. For these 42-day codes,

Evaluation and Management services on

the day of the delivery and during the 42-day post-delivery period are not separately reimbursable except as noted within this policy. Other Maternity (MMM) codes are assigned Global Days Values of 000 or XXX.

XXX N/A Per CMS, the Global Surgical Package concept does not apply to this code.

YYY 000

The local Medicare carrier determines whether the global concept applies and

establishes the postoperative period. Oxford assigns a Global Days Value of 000

to these codes.

ZZZ N/A

The code is related to another service and is always included in the Global Period of the primary service. The Global Surgical

Package concept does not apply to the code.

Services Included in the Global Package The following services, when provided within the Global Period by the Same Specialty Physician or Other Health Care Professional, are included in the

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Global Days (continued)

May 16, 2016

Global Surgical Package and are not separately reimbursable except as specified. Preoperative visits are not separately reimbursable services when

performed within the assigned Global Period. This period begins with the day before surgery for Major Procedures (those having a Global Days Value

of 090) and the day of surgery for procedures having a Global Days Value

other than 090. Complications following a procedure, including all additional medical and/or

surgical services required of the physician (not resulting in a return trip to the operating room) that occur within the designated Global Period.

Postoperative visits. This includes follow-up E/M visits that occur within the designated Global Period that are related to the patient recovery following

surgery. Post-procedure pain management by the Same Specialty Physician or

Other Health Care Professional. Selected supplies. Miscellaneous services related to the procedure, such as, dressing

changes; local incisional care; removal of operative pack; removal of

cutaneous sutures and staples, lines, wires, tubes, drains, casts, and

splints; insertion, irrigation and removal of urinary catheters, routine peripheral intravenous lines, nasogastric and rectal tubes; and changes and removal of tracheostomy tubes.

A procedures having a Global Days Value of 000, 010 or 090 that is performed during the postoperative period of a procedure having a Global Days Value of 010 or 090, when both procedures are reported by the Same Specialty Physician or Other Health Care Professional, is considered included in the Global Surgical Package of the initial procedure unless an appropriate modifier is appended.

Services Not Included in the Global Package Services of a physician who is not the Same Specialty Physician or Other

Health Care Professional. For situations involving transfer of care, see the Split Surgical Package policy for more information.

The initial consultation or evaluation of the problem to determine the need

for surgery when reported with modifier 57. This applies only to Major Procedures (those having a Global Days Value of 090). The initial evaluation is always included in the allowance for a procedure having a Global Days Value other than 090. Please see "Global Days Assignments".

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Global Days (continued)

May 16, 2016

Visits that are unrelated to the diagnosis for which the procedure was performed. (Use modifier 25 for the day of the procedure and modifier 24 during the postoperative period.)

Diagnostic tests and procedures (including lab and x-rays). Staged or related procedures or services during the postoperative period

(use modifier 58).

Clearly distinct procedures during the postoperative period that are not re-operations or treatment for complications. (use modifier 79).

Immunosuppressive therapy for organ transplants. Treatment for postoperative complications that requires a return trip to

the operating room (OR). (Use modifier 78).

Modifiers

Modifier Description

24

Unrelated Evaluation and Management Service by the

Same Physician or Other Qualified Health Care Professional During a Postoperative Period The physician or other qualified health care professional may

need to indicate that an evaluation and management service was performed during a postoperative period for a reason(s) unrelated to the original procedure. This circumstance may be reported by adding the modifier 24 to the appropriate level of

E/M service.

25

Significant, Separately Identifiable Evaluation and Management Service by the Same Physician or Other Qualified Health Care Professional on the Same Day of the Procedure or Other Service

It may be necessary to indicate that on the day a procedure or service identified by a CPT code was performed, the patient's condition required a significant, separately identifiable E/M

service above and beyond the other service provided or beyond the usual pre-operative and post-operative care associated with the procedure that was performed. A significant, separately identifiable E/M service is defined or substantiated by

documentation that satisfies the relevant criteria for the respective E/M service to be reported. The E/M service may be prompted by the symptom or condition for which the procedure and/or service was provided. As such, different diagnoses are not required for reporting of the E/M services on the same date.

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Reimbursement Policy Updates

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Global Days (continued)

May 16, 2016

This circumstance may be reported by adding modifier 25 to the appropriate level of E/M service. Note: This modifier is not used to report an E/M service that resulted in a decision to perform surgery. See modifier 57. For

significant, separately identifiable non-E/M services, see modifier 59.

57

Decision for Surgery An evaluation and management service that resulted in the initial decision to perform the surgery may be identified by adding modifier 57 to the appropriate level of E/M service. Note: This modifier should only be used in cases in which the decision for surgery was made during the preoperative period of

a major surgical procedure (Global Days Value of 090).

58

Staged or Related Procedure or Service by the Same Physician or Other Qualified Health Care Professional During the Postoperative Period It may be necessary to indicate that the performance of a

procedure or service during the postoperative period was (a) planned or anticipated (staged); (b) more extensive than the

original procedure; or (c) for therapy following a surgical procedure. This circumstance may be reported by adding modifier 58 to the staged or related procedure. Note: For treatment of a problem that requires a return to the operating/ procedure room (eg, unanticipated clinical condition), see modifier 78. Notes:

This modifier is not used to report the treatment of a complication that requires a return to the operating room (see modifier 78).

This modifier is not to be used with codes that by description include treatment or monitoring at one or more sessions at different patient encounters (i.e., 66762 and 66821). Please see the One or More Sessions Policy. Global

Days surgical package guidelines also apply to the procedure listed in the One or More Sessions policy. A postoperative period will be assigned to a subsequent procedure that is appropriately reported with modifier 58.

78 Unplanned Return to the Operating/Procedure Room by

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Reimbursement Policy Updates

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Global Days (continued)

May 16, 2016

the Same Physician or Other Qualified Health Care Professional Following Initial Procedure for a Related Procedure During the Postoperative Period It may be necessary to indicate that another procedure was

performed during the postoperative period of the initial procedure (unplanned procedure following initial procedure).

When this procedure is related to the first and requires the use of an operating/procedure room, it may be reported by adding modifier 78 to the related procedure. (For repeat procedures, see modifier 76.)

79

Unrelated Procedure or Service by the Same Physician or Other Qualified Health Care Professional During the Postoperative Period The individual may need to indicate that the performance of a procedure or service during the postoperative period was unrelated to the original procedure. This circumstance may be

reported by using modifier 79. (For repeat procedures on the

same day, see modifier 76.) Note: A postoperative period will be applied to a subsequent procedure that is appropriately reported with modifier 79.

Refer to official American Medical Association Current Procedural Terminology

(CPT) publications for additional information regarding the proper utilization of these modifiers. Oxford reserves the right to request and review clinical notes to substantiate the use of modifiers on any claim.

Maximum Frequency Per Day

May 16, 2016

Reformatted policy; transferred content to new template

Updated Maximum Frequency Per Day Code List (attachment file listing maximum frequency per day value assignments for CPT and HCPCS codes) to reflect

quarterly code edits (effective May 16, 2016): o Added G9481, G9482,

G9483, G9484, G9485,

MFD Determination: Part I The following criteria are first used to determine the MFD values for codes to

which these criteria are applicable: The service is classified as bilateral (CMS Indicators 1 or 3) on the Centers

for Medicare & Medicaid Services (CMS) National Physician Fee Schedule (NPFS) or the term 'bilateral' is included in the code descriptor. For the majority of these codes, the MFD value is 1. There are some codes that

describe more than one anatomical site or vertebral level that can be treated bilaterally where the MFD value may be more than 1.

Where the CPT or HCPCS code description/verbiage references reporting the code once per day, the MFD value is 1.

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Maximum Frequency Per Day (continued)

May 16, 2016

G9486, G9487, G9488, G9489 and G9490

o Updated maximum frequency per day value assignments for 11045,

11046, 11047, 71023,

71030, 71035, 73721, 73723, 74000, 74301, 75658, 75705, 75774, 75880, 75893, 75898, 75964, 75970, 76001, 76080, 76098, 77790,

85397, 86828, 86829, 88233, 88235, 88237, 88240, 88271, 88272, 88274, 88275, 88280, 88283, 88285, 88300, 88302, 88304, 88307,

88312, 88313, 88314,

88319, 88329, 88332, 88366, 88374, 88377, 88387, 88388, A0080, A0090, A0160, A0180, A0380, A0384, A0390, A0392, A0394, A0396,

A4206, A4207, A4209, A4211, A4212, A4213, A4215, A4222, A4223, A4230, A4231, A4234,

A4244, A4246, A4247, A4248, A4256, A4267, A4268, A4269, A4270,

A4283, A4285, A4300, A4305, A4306, A4310, A4311, A4312, A4313, A4314, A4315, A4316, A4322, A4327, A4328, A4331, A4333, A4334, A4338, A4340, A4344,

The service is anatomically or clinically limited with regard to the number of times it may be performed, in which case the MFD value is established at that value.

The CPT or HCPCS code description/verbiage indicates the number of times the service can be performed, in which case the MFD value is set at that

value.

CMS Durable Medical Equipment Medicare Administrative Contractor (DMEMAC) Local Coverage Determination (LCD) assigns an MFD value in which case the MFD value is set at that value.

Where the criteria above have not defined an MFD value, the CMS Medically Unlikely Edits (MUE) value, where available, will be utilized to establish an MFD value.

Where no other definitive value has been established based on the criteria above, drug HCPCS codes will have an MFD value of 999 which indicates they are exempt from the MFD policy.

Where no other definitive value has been established based on the criteria above, unlisted CPT and HCPCS codes will have an MFD value of 999 which indicates they are exempt from the MFD policy.

Where no other definitive value has been established based on the criteria

above, new CPT codes released by the American Medical Association and new HCPCS codes released by CMS since the last MFD value update (not covered by any of the above criteria), will have an MFD value of 100.

MFD Determination: Part II When none of the criteria listed in Part I apply to a code, data analysis is

conducted to establish MFD values according to common billing patterns. When a code has 50 or more claim occurrences in a data set, the MFD

values are determined through claim data analysis and are set at the 100th percentile (i.e., the highest number of units billed for that CPT or HCPCS

code in the data set). If the 100th percentile exceeds the 98th percentile by a factor of four, the MFD will be set at the 98th percentile.

When a code has less than 50 claim occurrences in a data set, the MFD

values will be set at the default of 100 until the next annual analysis. In any case where, in Oxford's judgment, the 98th percentile does not

account for the clinical circumstances of the services billed, the MFD for a code may be increased so as to capture only obvious billing submission and data entry errors.

The "MFD per Day Policy List" list below contains the most current MFD values.

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Maximum Frequency Per Day (continued)

May 16, 2016

A4346, A4354, A4355, A4357, A4358, A4361, A4363, A4364, A4366, A4367, A4371, A4377, A4384, A4389, A4390,

A4399, A4400, A4402,

A4404, A4406, A4411, A4412, A4417, A4423, A4424, A4428, A4455, A4461, A4465, A4466, A4481, A4559, A4602, A4618, A4628, A4629,

A4630, A4651, A4657, A4680, A4690, A4709, A4719, A4750, A4755, A4770, A4772, A4773, A4860, A4927, A4928, A4930, A5071, A5073,

A5082, A5083, A5093,

A5105, A5113, A5114, A5122, A5131, A5200, A6021, A6025, A6196, A6197, A6199, A6204, A6205, A6206, A6207, A6208, A6209, A6210,

A6211, A6213, A6217, A6218, A6221, A6234, A6235, A6237, A6238, A6240, A6245, A6248,

A6255, A6258, A6260, A6262, A6404, A6407, A6410, A6441, A6442,

A6444, A6447, A6449, A6451, A6452, A6455, A7001, A7002, A7004, A7007, A7008, A7012, A7015, A7032, A7033, A7038, A7045, A7505, A7525, A7527, A9152,

Maximum Frequency Per Day List

The MFD values apply whether a physician, hospital, ambulatory surgical center, or other health care professional submits one CPT or HCPCS code with multiple units on a single claim line or multiple claim lines with one or more unit(s) on each line. It is common coding practice for some CPT and HCPCS

codes to be submitted with multiple units. However, when reporting the same CPT or HCPCS code on multiple and/or separate claim lines, the claim line may be classified as a duplicate 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. Modifiers LT and RT Restrictions 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, hospital, ambulatory surgical center, 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 Modifiers LT and RT" list will be considered

informational only. Codes Restricting Modifiers LT and RT

There may be situations where a physician, hospital, ambulatory surgical

center, 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. Medically Unlikely Edit Adjudication Indicator (MAI) 2 CMS has identified CPT/HCPCS codes where the units of service (UOS) on the

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Maximum Frequency Per Day (continued)

May 16, 2016

A9153, A9180, A9272, A9273, A9274, A9501, A9509, A9517, A9527, A9528, A9529, A9530, A9531, A9532, A9555,

A9563, B4081, B4082,

B4102, B4103, B4104, B4157, B4158, B4162, B4168, B4176, B5000, D1999, E0465, E0466, E0700, E1012, E2599, G0257,

G0269, H0006, H0014, H0015, H0025, J0588, J2426, J7060, J7297, J7298, J8501, J8540, J8650, J9185, J9201, J9218, J9302, J9330,

J9357, K0604, L2840,

L2850, L3320, L8624, P9016, P9020, P9022, P9033, Q0081, Q0138, Q0139, Q0162, Q0163, Q0164, Q0166, Q0167, Q0169, Q0173, Q0175,

Q0177, Q0180, Q4005, Q4007, Q4008, Q4009, Q4014, Q4018, Q4019, Q4021, Q4023, Q4024,

Q4030, Q4031, Q4032, Q4034, Q4036, Q4037, Q4039, Q4040, Q4041,

Q4042, Q4044, Q4045, Q4048, S0209, S0215, S0512, S0800, S0810, S0812, S1015, S3866, S4011, S4026, S4027, S4028, S5010, S5170, S8130, S8131, S8415,

same date of service in excess of the MUE value would be considered impossible because it is contrary to statute, regulation or sub-regulatory guidance. Therefore, Oxford will not allow units in excess of the MFD value to be reimbursed for CPT/HCPCS codes assigned an MAI indicator of “2”. Per CMS guidelines, no modifier override will be allowed nor will the MFD value be

overridden by supplying documentation for adjustment requests.

CMS MUE File

Modifiers

Modifier Description

59

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, 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.

76

Repeat Procedure or Service by Same Physician or Other Qualified Health Care Professional 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

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Maximum Frequency Per Day (continued)

May 16, 2016

S8431, S8490, S9024, S9090, S9430, S9435, S9982, S9986, T1006, T1007, T1012, T1014, T1021, T1024, T2003,

T2005, T2028, T2029,

T2038, T2049, T4537, T4540, T4542, V2100, V5266, V5267 and V5281

Updated list of Codes Restricting Modifiers LT and RT (attachment file listing codes that allow up to

the MFD limit that have “bilateral” or “unilateral or bilateral” in the description or where the concept of laterality does not apply) to reflect quarterly code edits (effective

May 16, 2016); added G9481,

G9482, G9483, G9484, G9485, G9486, G9487, G9488, G9489 and G9490

procedure or service. Note: This modifier 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.

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.

91

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 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.

XE

Separate Encounter

A service that is distinct because it occurred during a separate encounter.

XS Separate Structure A service that is distinct because it was performed on a separate organ/structure.

XU Unusual Non-Overlapping Service The use of a service that is distinct because it does not overlap usual components of the main service.

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Maximum Frequency Per Day (continued)

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Anatomic Modifiers

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

Procedure and Place of Service

May 1, 2016

Reformatted policy; transferred content to new template

Updated Procedure and Place of

Oxford will reimburse CPT and HCPCS codes when reported with an appropriate place of service (POS).

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Procedure and Place of Service (continued)

May 1, 2016 Service List [attachment file listing applicable CPT/HCPCS codes with corresponding place of service (POS) codes] to reflect quarterly code edits (effective

May 1, 2016); added G9490

with POS 12 and 14

Many CPT and HCPCS codes include a place of service in their description or coding guidelines include the place(s) of service where the code may be performed. For example, CPT code 94002 (Ventilation assist and management, initiation of pressure or volume preset ventilators for assisted or controlled breathing; hospital inpatient/observation, initial day) would not be

appropriate for reporting in an office or home POS because its code description

identifies hospital inpatient or observation. The Centers for Medicare & Medicaid Services (CMS) maintain the Place of Service Code set, which are two-digit codes submitted on the CMS 1500 Health Insurance Claim Form or its electronic equivalent to indicate the setting in which a service was provided. The website containing the POS Code

set can be accessed via this link:

CMS Place of Service Code Set Oxford has established a list of CPT and HCPCS codes along with their

appropriate places of service. Codes not included on the list are out of scope

for this policy. Please refer to the list located in the attachments section of this policy.

REVISED

Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Care Plan

Oversight

Jun. 1, 2016 Reformatted policy; transferred

content to new template Revised list of reimbursable

procedure codes; added CPT code 0405T

Oxford considers Care Plan Oversight Services to be reimbursable services

when submitted with the following codes only: CPT codes 94005, 99340, 99375, 99378, 99380, 0405T HCPCS codes G0179, G0180, G0181, G0182 CPO services are reimbursed for 30 minutes or more per Centers for Medicare & Medicaid Services (CMS) guidelines.

The following codes are not reimbursable for Care Plan Oversight Services: CPT codes 99339, 99374, 99377, 99379 HCPCS codes S0220, S0221, S0250, S0270, S0271, S0272

Modifier SU

Jun. 1, 2016

Reformatted policy; transferred content to new template

Revised reimbursement guidelines; removed language

The Centers for Medicare and Medicaid Services (CMS) indicates that the Health Care Common Procedure Coding System (HCPCS) modifier SU,

Procedure performed in physician's office (to denote use of facility and equipment), is not payable. CMS establishes Relative Value Units (RVU) for

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Modifier SU (continued)

Jun. 1, 2016 indicating some provider contracts may allow for reimbursement of services appended with modifier “SU” in an office place of service

CPT and HCPCS codes that include the costs of running an office (such as rent, equipment, supplies and non-physician staff costs) which are referred to as the practice expense RVU. In accordance with CMS, Oxford does not allow reimbursement for services appended with modifier SU in an office place of service, since the use of the office facility and equipment is included in the

practice expense RVU, or the costs associated with operating an office.

If the charges associated with the use of the modifier SU are submitted by a different provider than the physician performing the office procedure, they will not be considered for separate reimbursement since these practice expenses are considered included in the reimbursement for the physician performing the service.

New Patient Visit

Jun. 1, 2016

Reformatted policy; transferred content to new template

Updated policy overview; added language to indicate this policy now also addresses the

appropriate submission of an initial visit HCPCS code

Revised reimbursement guidelines; added language to indicate: o According to CMS, an initial

visit is the first patient

encounter for a specific purpose (i.e., the first E/M visit, the first annual wellness visit, the first E/M visit to discuss diabetic

sensory neuropathy, etc.); a subsequent visit is any

encounter that occurs after the initial patient encounter

o Oxford will only reimburse an initial visit HCPCS code when the same specialty physician has not previously reported

the same initial visit HCPCS

According to the Centers for Medicare and Medicaid Services (CMS), a New Patient is a patient who has not received any professional services from the physician, or another physician of the same specialty who belongs to the same group practice, within the past three years.

Therefore, Oxford will reimburse a New Patient Evaluation and Management (E/M) code only when the elements of that definition have been met. In the instance where a physician is on-call or covering for another physician and billing under the same Federal Tax Identification number, the patient's encounter with the on-call physician is classified as it would have been classified by the physician who was not available. This patient is not

considered a New Patient merely because the visit is covered by an on-call physician from whom the patient has not previously received services. According to CMS, an Initial Visit is the first patient encounter for a specific purpose, i.e., the first E/M visit, the first annual wellness visit, the first E/M

visit to discuss diabetic sensory neuropathy, etc. A Subsequent Visit is any encounter that occurs after the initial patient encounter.

Therefore Oxford will only reimburse an Initial Visit HCPCS Code when the Same Specialty Physician has not previously reported the same Initial Visit HCPCS code or a HCPCS code described as a Subsequent Visit for the same patient.

For the purposes of this policy, Same Specialty Physician is defined as a

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

New Patient Visit (continued)

Jun. 1, 2016 code or a HCPCS code described as a subsequent visit for the same patient

Updated definitions; added definition of “initial visit” and

“subsequent visit”

Updated Questions and Answers; added Q&A #3 to indicate: o Q3: Will UnitedHealthcare

reimburse the initial visit HCPCS code if the patient has received an initial or

subsequent visit in the past? o A3: No - UnitedHealthcare

will only reimburse an initial visit if the patient has not previously been seen for an initial or subsequent visit

Physician and/or Other Qualified Health Care Professional of the same group and same specialty reporting the same Federal Tax Identification number.

One or More Sessions

Jun. 1, 2016

Reformatted policy; transferred content to new template

Updated Questions and Answers; added Q&A #5 to indicate: o Q5: When does the defined

treatment or monitoring

period of a procedure begin and end?

o A5: The defined treatment or monitoring period begins the day of the procedure and

then 10, 30 or 90 days before the procedure and

following the procedure, beginning the first day of the procedure [example: a procedure having a defined treatment or monitoring period of 90 days is

performed on 10/1;

Oxford will reimburse a CPT or HCPCS code only once during the Defined Treatment or Monitoring Period.

The Defined Treatment Period mirrors the National Physician Fee Schedule (NPFS) global fee period. The Monitoring Period is in accordance with the code description and/or coding guidelines.

National Physician Fee Schedule

Multiple submissions of the same CPT or HCPCS code by the Same Physician,

Hospital, Ambulatory Surgical Center or Other Health Care Professional for the same patient during the Defined Treatment Period or Monitoring Period will be

denied as part of the global service unless an appropriate modifier is reported. Refer to the Modifiers and Attachments sections of this policy.

Services addressed in the One or More Sessions Policy may also be subject to global surgical package guidelines. Please refer to the Global Days policy for additional information. Modifiers

Modifiers offer the physician, hospital, ambulatory surgical center or healthcare professional a way to identify that a service or procedure has been

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

One or More Sessions (continued)

Jun. 1, 2016 procedures reported on 10/1 and during the 90-day treatment or monitoring period before and after (7/3 through and including 12/30)

are included in the treatment

or monitoring period] Revised One or More Sessions

Policy List (attachment file listing codes with a defined treatment or monitoring period): o Added A0000

o Removed 65855

altered in some way. Under appropriate circumstances, modifiers should be used to identify unusual circumstances, staged or related procedures, distinct procedural services or separate anatomical location(s). Oxford recognizes the following designated modifiers, when appropriately

reported, under this reimbursement policy:

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 left side of the body)

50 Bilateral procedure

52 Reduced services

53 Discontinued procedure

54 Surgical care only

55 Postoperative management only

56 Preoperative management only

79 Unrelated Procedure or Service by the Same Physician or Other Qualified Health Care Professional During the Postoperative Period

Supply Policy

Jun. 1, 2016

Reformatted policy; transferred content to new template

Revised policy application language/reimbursement guidelines: o Added clarify policy

guidelines apply to physician

and other healthcare professional services reported on a HCFA 1500 claim form only; removed references to UB04 claim

forms, hospitals, and ambulatory surgical centers

o Added language to clarify Oxford will not separately

Supply Reimbursement in a Physician’s or Other Qualified Health Care Professional’s Office and Other Nonfacility Places of Service Pursuant to Centers for Medicare and Medicaid Services (CMS) policy, certain HCPCS supply codes are not separately reimbursable as the cost of supplies is incorporated into the Practice Expense Relative Value Unit (RVU) for the Evaluation and Management (E/M) service or procedure code. Consistent with

CMS, Oxford will not separately reimburse the HCPCS supply codes when

those supplies are provided on the same day as an E/M service and/or procedure performed in a physician’s, or other qualified health care professional’s office and other nonfacility places of service. The Oxford Supply Policy Codes List (see the attachments section of this

policy) contains the codes that are not separately reimbursable under this policy. It is developed based on the CMS National Physician Fee Schedule (NPFS) Relative Value File and consists of codes that based on their descriptions, CMS considers part of the practice expense and not separately

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Supply Policy (continued)

Jun. 1, 2016

reimburse HCPCS supply codes when the supplies are provided on the same day as an E/M service and/or a procedure performed in a

physician’s or other qualified

health care professional’s office or other nonfacility place of service

o Added language to indicate Oxford will deny HCPCS code L8680 (implantable

neurostimulator electrode) when billed with CPT code 63650 (percutaneous implantation of neurostimulator electrode array, epidural) in an office

or non-facility place of

service to further align with CMS guidelines

Updated Supply Codes List (attachment file listing HCPCS supply codes that are not separately reimburseable) to

include place of service (POS) criteria codes 1, 3, 4, 9, 11, 12, 13, 14, 15, 16, 17, 20, 33, 49, 50, 54, 55, 57, 60, 62, 65, 71,

72, 81 and 99

reimbursable. Supplies, Purchased Durable Medical Equipment (DME), Orthotics, Prosthetics, Biologicals and Drugs submitted with a J Code Reported with a Facility Place of Service 19, 21, 22, 23, 24

CMS follows a Prospective Payment System (PPS) where Medicare payment is

based on a predetermined, fixed amount payable to a facility for inpatient or outpatient hospital services. In addition, CMS reimburses ambulatory surgery centers under an Ambulatory Payment Classification (APC) payment methodology. With these fixed rates all costs associated with drugs and supplies are also deemed included in the global payment to the facility and not considered separately reimbursable when reported on a CMS-1500 claim form

by a physician or other qualified healthcare professional. Consistent with CMS, Oxford will not allow separate reimbursement for specific HCPCS supplies, purchased DME, orthotics, prosthetics, biological, and drugs reported with a HCPCS J code when submitted on a CMS-1500 claim form by any physician or other qualified healthcare professional in the following facility

POS 19, 21, 22, 23, and 24.

The purchase of certain DME, orthotics, and prosthetics will not be separately reimbursed when reported by a physician or other qualified health care professional on a CMS-1500 claim form in POS 19, 21, 22, 23 or 24 and the services are reported with no modifier or with one of the following purchase modifiers:

NU New Equipment (use the NR modifier when DME which was new at the time of rental is subsequently purchased).

UE Used Equipment NR New when rented

KM Replacement of facial prosthesis including new impression/moulage KN Replacement of facial prosthesis using previous master model

Please refer to the attachments section of this policy for a list of those codes/services that are not separately reimbursable in POS 19, 21, 22, 23 and 24. Durable Medical Equipment, Orthotics, Prosthetics, and Related Supplies Reported with Facility Places of Service 31 and 32 In alignment with the CMS PPS reimbursement methodology, Oxford considers

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Supply Policy (continued)

Jun. 1, 2016

payment for certain DME, orthotics, prosthetics and related supply items on the CMS Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) fee schedule to be included in the payment to the facility and not reimbursed separately when reported by a physician or other qualified health care professional on a CMS-1500 claim form with one of the following facility

POS:

POS 31: Skilled Nursing Facility POS 32: Nursing Facility Please refer to the attachments section of this policy for a list of codes/services that are not separately reimbursable in POS 31 and 32.

Bundling HCPCS Code L8680 with CPT Code 63650 To further align with CMS, the Oxford Supply Policy will deny HCPCS code L8680 (Implantable neurostimulator electrode), when billed with CPT code 63650 (Percutaneous implantation of neurostimulator electrode array, epidural) in an office or nonfacility place of service.

Casting and Splint Supplies

HCPCS codes A4570, A4580, and A4590 which were previously used for billing of splints and casts are invalid for Medicare use effective July 1, 2001, and new temporary Q codes were established to reimburse physicians and other practitioners for the supplies used in creating casts. Consistent with CMS, Oxford will no longer reimburse HCPCS codes A4570, A4580, and A4590 for casting and splint supplies. Physicians and other qualified health care

professionals should be using the temporary Q codes (Q4001-Q4051) for reimbursement of casting and splint supplies. Implantable Tissue Markers

CMS clarifies that implantable tissue markers (HCPCS code A4648) and implantable radiation dosimeters (HCPCS code A4650) are separately billable and payable when used in conjunction with CPT codes 19499, 32553, 49411

or 55876 on a claim for physician or other qualified health care professional services. Consistent with CMS, Oxford will allow separate reimbursement for HCPCS codes A4648 and A4650 when billed on the same date of service with either CPT codes 19499, 32553, 49411 or 55876. If not reported with at least one of these CPT codes, HCPCS codes A4648 and A4650 are not separately reimbursable.

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Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Supply Policy (continued)

Jun. 1, 2016 Supply Code 99070 For reimbursement of covered medical and surgical supplies, an appropriate Level II HCPCS code must be submitted. The non-specific CPT code 99070 (supplies and materials, except spectacles, provided by the physician or other qualified health care professional over and above those usually included with

the office visit or other services rendered (list drugs, trays, supplies, or

materials provided)) is not reimbursable in any setting.