March 2018 policy update bulletin - OXHP2 Oxford® Policy Update Bulletin: March 2018 Oxford®...

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

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

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

Oxford® Medical and Administrative Policy.*

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

March 2018

policy update bulletin Medical & Administrative Policy Updates

2 Oxford® Policy Update Bulletin: March 2018

Oxford® Medical and Administrative Policy Updates

Overview

Oxford

Tips for using the Policy Update Bulletin:

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

directed to the corresponding policy update summary.

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

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

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review

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

device or procedure)

Updated

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

to the clinical coverage criteria or documentation review requirements;

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

list(s) of applicable codes may have been updated

Revised

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

the clinical coverage criteria and/or documentation review requirements

Replaced

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

Retired

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

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

therefore not excluded as unproven/not medically necessary services,

unless coverage guidelines or criteria are otherwise documented in

another policy

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

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

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

federal or state regulatory requirements. Additionally, UnitedHealthcare

reserves the right to review the clinical evidence supporting the safety

and effectiveness of a medical technology prior to rendering a coverage

determination.

This bulletin provides complete details on Oxford® Clinical,

Administrative and Reimbursement Policy updates. The inclusion of

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

bulletin indicates only that UnitedHealthcare has recently adopted a

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

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

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

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

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

plan documents exclude from benefit coverage health services

identified as investigational or unproven/not medically necessary.

Physicians and other health care professionals may not seek or

collect payment from a member for services not covered by the

applicable benefit plan unless first obtaining the member’s written

consent, acknowledging that the service is not covered by the

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

A complete library of Oxford® Medical and

Administrative Policies is available at

OxfordHealth.com > Providers > Tools & Resources >

Medical Information > Medical and Administrative Policies.

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

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



In This Issue

Oxford

Clinical Policy Updates Page

NEW

Denosumab (Prolia® & Xgeva®) – Effective Mar. 1, 2018 ....................................................................................................................................... 7

UPDATED

Actemra® (Tocilizumab) Injection for Intravenous Infusion – Effective Apr. 1, 2018 ................................................................................................ 10 Balloon Sinus Ostial Dilation – Effective Apr. 1, 2018 .......................................................................................................................................... 11 Blepharoplasty, Blepharoptosis and Brow Ptosis Repair – Effective Apr. 1, 2018 ..................................................................................................... 12 Breast Reduction Surgery – Effective Apr. 1, 2018 .............................................................................................................................................. 12 Cytological Examination of Breast Fluids for Cancer Screening – Effective Apr. 1, 2018 ........................................................................................... 15 Epidural Steroid and Facet Injections for Spinal Pain – Effective Mar. 1, 2018 ........................................................................................................ 16 Fecal Calprotectin Testing – Effective Mar. 1, 2018 ............................................................................................................................................. 17 Glaucoma Surgical Treatments – Effective Apr. 1, 2018 ....................................................................................................................................... 17 Home Hemodialysis – Effective Mar. 1, 2018 ...................................................................................................................................................... 18 Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion – Effective Apr. 1, 2018 ......................... 19 Orencia® (Abatacept) Injection for Intravenous Infusion – Effective Mar. 1, 2018 ................................................................................................... 20 Outpatient Physical & Occupational Therapy for Self-Funded Groups – Effective Mar. 1, 2018 .................................................................................. 22 Outpatient Physical and Occupational Therapy (OptumHealth Care Solutions Arrangement) – Effective Mar. 1, 2018 .................................................. 25 Panniculectomy and Body Contouring Procedures – Effective Apr. 1, 2018 ............................................................................................................. 28 Rhinoplasty and Other Nasal Surgeries – Effective Apr. 1, 2018 ........................................................................................................................... 30

REVISED

Abnormal Uterine Bleeding and Uterine Fibroids – Effective Apr. 1, 2018 ............................................................................................................... 34 Attended Polysomnography for Evaluation of Sleep Disorders – Effective Apr. 1, 2018 ............................................................................................ 35 Buprenorphine (Probuphine® & Sublocade™) – Effective Apr. 1, 2018 ................................................................................................................... 38 Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes – Effective Apr. 1, 2018 ......................................................................... 42 Denosumab (Prolia® & Xgeva®) – Effective Jun. 1, 2018 ...................................................................................................................................... 47 Drug Coverage Criteria - New and Therapeutic Equivalent Medications – Effective Apr. 1, 2018 ................................................................................ 51 Drug Coverage Guidelines – Effective Mar. 1, 2018 ............................................................................................................................................. 51

o Prolia, Xgeva (Denosumab) ........................................................................................................................................................................ 51 o Symdeko (Tezacaftor/Ivacaftor) ................................................................................................................................................................. 52

Drug Coverage Guidelines – Effective Apr. 1, 2018 ............................................................................................................................................. 52 o Arymo ER (Morphine Sulfate) ..................................................................................................................................................................... 52 o Avinza (Morphine Sulfate Controlled Release) (Brand Only) ............................................................................................................................ 52 o Baxdela (Delafloxacin) ............................................................................................................................................................................... 52



In This Issue

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o Cabometyx (Cabozantinib) ......................................................................................................................................................................... 52 o Dolophine (Methadone).............................................................................................................................................................................. 52 o Duragesic (Brand Only) (Fentanyl) .............................................................................................................................................................. 52 o Embeda (Morphine Sulphate and Naltrexone HCL)......................................................................................................................................... 52 o Entresto (Valsartan-Sacubitril) .................................................................................................................................................................... 52 o Exalgo (Hydromorphone) ........................................................................................................................................................................... 53 o Flolipid (Simvastatin Suspension) ................................................................................................................................................................ 53 o Hemlibra (Emicizumab-Kxwh) ..................................................................................................................................................................... 53 o Hysingla ER (Hydrocodone Bitartrate) .......................................................................................................................................................... 53 o Impoyz (Clobetasol Propionate) .................................................................................................................................................................. 53 o Kadian (Morphine Sulfate Extended Release) ................................................................................................................................................ 53 o Morphabond ER (Morphine Sulfate) ............................................................................................................................................................. 53 o Morphine Sulfate Controlled-Release (Generic MS Contin) .............................................................................................................................. 53 o MS Contin ................................................................................................................................................................................................ 53 o Noctiva (Desmopressin Acetate) ................................................................................................................................................................. 53 o Nucynta ER (Tapentadol Extended Release) ................................................................................................................................................. 53 o Opana ER (Oxymorphone Extended Release) ................................................................................................................................................ 54 o Oxycontin (Oxycodone Extended Release) .................................................................................................................................................... 54 o Oxycodone ER 12hr Tablet ......................................................................................................................................................................... 54 o Oxymorphone Extended Release ................................................................................................................................................................. 54 o Probuphine (Buprenorphine) ....................................................................................................................................................................... 54 o Steglujan (Ertugliflozin/Sitagliptin) .............................................................................................................................................................. 54 o Sublocade (Buprenorphine Extended-Release) .............................................................................................................................................. 54 o Trintellix (Vortioxetine) .............................................................................................................................................................................. 54 o Troxyca ER (Oxycodone HCL and Naltrexone) ............................................................................................................................................... 54 o Vantrela ER (Hydrocodone Bitartrate) .......................................................................................................................................................... 54 o Xeljanz (Tofacitinib) .................................................................................................................................................................................. 54 o Xeljanz XR ............................................................................................................................................................................................... 55 o Xtampza ER (Oxycodone) .......................................................................................................................................................................... 55 o Zohydro ER (Hydrocodone Bitartrate Extended Release) ................................................................................................................................ 55

Elbow Replacement Surgery (Arthroplasty) – Effective Apr. 1, 2018 ...................................................................................................................... 55 Electrical and Ultrasound Bone Growth Stimulators – Effective Apr. 1, 2018 ........................................................................................................... 56 Functional Endoscopic Sinus Surgery (FESS) – Effective Apr. 1, 2018 .................................................................................................................... 56 Hip Resurfacing and Replacement Surgery (Arthroplasty) – Effective Apr. 1, 2018 .................................................................................................. 56 Hysterectomy for Benign Conditions – Effective Apr. 1, 2018 ............................................................................................................................... 57 Implanted Electrical Stimulator for Spinal Cord – Effective Apr. 1, 2018 ................................................................................................................ 57 Luxturna™ (Voretigene Neparvovec-Rzyl) – Effective May 1, 2018 ........................................................................................................................ 58 Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions – Effective Apr. 1, 2018 ......................................................... 58 Observation Care – Effective Apr. 1, 2018 ......................................................................................................................................................... 63



In This Issue

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Obstructive Sleep Apnea Treatment – Effective Apr. 1, 2018 ................................................................................................................................ 64 Office Based Program – Effective Apr. 1, 2018 ................................................................................................................................................... 66 Omnibus Codes – Effective Apr. 1, 2018 ............................................................................................................................................................ 67 Orthognathic (Jaw) Surgery – Effective Apr. 1, 2018 ........................................................................................................................................... 70 Orthopedic Services – Effective Apr. 1, 2018 ...................................................................................................................................................... 73 Outpatient Cardiac Telemetry – Effective Apr. 1, 2018 ........................................................................................................................................ 75 Pneumatic Compression Devices – Effective Apr. 1, 2018 .................................................................................................................................... 76 Preventive Care Services – Effective Apr. 1, 2018 ............................................................................................................................................... 76 Respiratory Interleukins (Cinqair®, Fasenra®, and Nucala®) – Effective Apr. 1, 2018 ............................................................................................... 77 Shoulder Replacement Surgery (Arthroplasty) – Effective Apr. 1, 2018 ................................................................................................................. 84 Site of Service Guidelines for Certain Outpatient Surgical Procedures – Effective Apr. 1, 2018 .................................................................................. 84 Sodium Hyaluronate – Effective Apr. 1, 2018 ..................................................................................................................................................... 86 Specialty Medication Administration - Site of Care Review Guidelines – Effective Apr. 1, 2018 .................................................................................. 89 Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins – Effective Apr. 1, 2018 ...................................................................... 90 Surgical Treatment for Spine Pain – Effective Apr. 1, 2018 .................................................................................................................................. 94 Temporomandibular Joint Disorders – Effective Apr. 1, 2018 ................................................................................................................................ 96 Total Knee Replacement Surgery (Arthroplasty) – Effective Apr. 1, 2018 ............................................................................................................... 97 Transcranial Magnetic Stimulation – Effective Apr. 1, 2018 .................................................................................................................................. 97

Administrative Policy Updates

NEW

New York & Connecticut Participating Surgeons Using Non- Participating Providers for Intraoperative Neuro-Monitoring (IONM) –

Effective Jun. 1, 2018 .................................................................................................................................................................................... 100

UPDATED

Non-Participating Provider Consent Form Protocol – Effective Mar. 1, 2018 ........................................................................................................... 102

REVISED

Formula & Specialized Food – Effective Apr. 1, 2018 .......................................................................................................................................... 104 In-Network Exceptions for Breast Reconstruction Surgery Following Mastectomy – Effective Apr. 1, 2018 ................................................................. 107 Newborns – Effective Apr. 1, 2018 ................................................................................................................................................................... 107 Precertification Exemptions for Outpatient Services – Effective Apr. 1, 2018 ......................................................................................................... 108 Referrals – Effective Apr. 1, 2018 .................................................................................................................................................................... 108



In This Issue

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Reimbursement Policy Updates

NEW

Multiple Procedure Payment Reduction (MPPR) for Diagnostic Imaging – Effective Apr. 1, 2018 ............................................................................... 111

UPDATED

After Hours and Weekend Care – Effective Apr. 1, 2018 ..................................................................................................................................... 112 Evaluation and Management (E/M) – Effective Mar. 1, 2018 ................................................................................................................................ 113 Increased Procedural Services – Effective Mar. 1, 2018 ...................................................................................................................................... 115 Modifier SU – Effective Apr. 1, 2018 ................................................................................................................................................................. 117 Nonphysician Health Care Codes – Effective Apr. 1, 2018 ................................................................................................................................... 117 Observation Care Evaluation and Management Codes – Effective Apr. 1, 2018 ...................................................................................................... 118 Obstetrical Policy – Effective Apr. 1, 2018 ......................................................................................................................................................... 120 Standby Services – Effective Apr. 1, 2018 ........................................................................................................................................................ 121 Wrong Surgical or Other Invasive Procedures – Effective Mar. 1, 2018 ................................................................................................................. 121

REVISED

B Bundle Codes – Effective Apr. 1, 2018 ........................................................................................................................................................... 123 Drug Testing – Effective Mar. 1, 2018 .............................................................................................................................................................. 124 Reimbursement for Comprehensive and Component CPT Codes (CES) – Effective Mar. 1, 2018 ............................................................................... 125

RETIRED/REPLACED

Advanced Practice Provider Evaluation and Management Procedures – Effective Mar. 1, 2018 ................................................................................. 128 Multiple Imaging Rules – Effective Apr. 1, 2018 ................................................................................................................................................. 128


Clinical Policy Updates

Oxford

Policy Title Effective Date Coverage Rationale

NEW

Denosumab (Prolia® & Xgeva®)

Mar. 1, 2018

This policy refers to the following denosumab products: Prolia Xgeva

Proven

Prolia (denosumab) is proven and medically necessary for: The treatment of postmenopausal patients with osteoporosis, or to increase bone mass in patients

with osteoporosis at high risk for fracture who meet ALL of the following criteria: o Diagnosis of osteoporosis; and o One of the following:

BMD T-score ≤ -2.5 based on BMD measurements from lumbar spine (at least two vertebral bodies), hip

(femoral neck, total hip), or radius (one-third radius site); or History of one of the following resulting from minimal trauma:

- Vertebral compression fracture - Fracture of the hip - Fracture of the distal radius

- Fracture of the pelvis - Fracture of the proximal humerus

or Both of the following:

- BMD T-score between -1 and -2.5 (BMD T-score greater than-2.5 and less than or equal to -1) based on BMD measurements from lumber spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site); and

- One of the following:

FRAX 10-year fracture probabilities: major osteoporotic fracture at 20% or more FRAX 10-year fracture probabilities: hip fracture at 3% or more; and

and o History of failure, contraindication, or intolerance to oral or intravenous bisphosphonate therapy; and

o Prolia dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 60 mg every 6 months; and

o Authorization is for no more than 12 months.

To increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy for

non-metastatic prostate cancer in patients who meet ALL of the following criteria: o Diagnosis of non-metastatic prostate cancer; and o Patient is receiving androgen deprivation therapy; and o History of failure, contraindication, or intolerance to oral or intravenous bisphosphonate therapy; and o Prolia dosing is in accordance with the United States Food and Drug Administration approved labeling:



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NEW

Denosumab (Prolia® & Xgeva®) (continued)

Mar. 1, 2018

maximum dosing of 60 mg every 6 months; and o Authorization is for no more than 12 months.

To treat patients at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer in patients who meet ALL of the following criteria: o Diagnosis of breast cancer; and

o Patient is receiving aromatase inhibitor therapy; and o History of failure, contraindication, or intolerance to oral or intravenous bisphosphonate therapy; and o Prolia dosing is in accordance with the United States Food and Drug Administration approved labeling:

maximum dosing of 60 mg every 6 months; and

o Authorization is for no more than 12 months. Xgeva (denosumab) is proven and medically necessary for: The prevention of skeletal-related events in patients with multiple myeloma and with bone

metastases from solid tumors when ALL of the following criteria are met:

o Patient is one of the following: Patient is ≥ 18 years of age; or

Patient is a skeletally mature adolescent as defined by having at least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus)

and o One of the following:

Diagnosis of multiple myeloma; or

Presence of metastatic disease secondary to a solid tumor (e.g., bladder, kidney, lung, ovarian, thyroid, etc.)

and o Individual has an expected survival of 3 months or greater; and o Refractory (within the past 30 days), contraindication (including renal insufficiency), or intolerance to

treatment with intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid) ; and

o Xgeva dosing is in accordance with the United States Food and Drug Administration approved labeling:

maximum dosing of 120 mg every 4 weeks; and o Authorization is for no more than 12 months.

The treatment of giant cell tumor of the bone when ALL of the following criteria are met: o Patient is one of the following:

Patient is ≥ 18 years of age; or


and



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NEW


Mar. 1, 2018 o Diagnosis of localized or metastatic giant cell tumor of the bone; and o Disease is one of the following:

Unresectable; or

Surgical resection is likely to result in severe morbidity and


maximum dosing of 120 mg every 4 weeks (additional 120 mg doses allowed on Day 8 and 15 in the first month of therapy); and


The treatment of hypercalcemia of malignancy when ALL of the following criteria are met: o Patient is one of the following:

Patient is ≥ 18 years of age; or Patient is a skeletally mature adolescent as defined by having at least 1 mature long bone (e.g., closed

epiphyseal growth plate of the humerus) and

o Diagnosis of hypercalcemia of malignancy as defined as: albumin-corrected serum calcium level greater than 12.5 mg/dL (3.1 mmol/L); and

o No pre-existing hypocalcemia (i.e., serum calcium or corrected calcium within normal limits per laboratory reference); and

o Refractory (within the past 30 days), contraindication (including renal insufficiency), or intolerance to treatment with intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid); and


maximum dosing of 120 mg every 4 weeks (additional 120 mg doses allowed on Day 8 and 15 in the first month of therapy); and

o Authorization is for no more than 12 months. Unproven

Xgeva is unproven and not medically necessary for the following indications:

Combination therapy of denosumab and intravenous bisphosphonates Bone loss associated with hormone-ablation therapy (other than aromatase inhibitors) in breast/prostate cancer Cancer pain

Central giant cell granuloma Hyper-parathyroidism Immobilization hypercalcemia Osteogenesis imperfecta Osteopenia



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Policy Title Effective Date Summary of Changes Coverage Rationale

UPDATED

Actemra® (Tocilizumab) Injection for

Intravenous Infusion

Apr. 1, 2018

Updated coverage rationale; replaced language indicating “this policy refers to Actemra

(tocilizumab) injection for intravenous infusion” with “this policy refers only to Actemra

(tocilizumab) injection for intravenous infusion for the treatment of rheumatoid arthritis, polyarticular juvenile

idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome; Actemra for self-administered subcutaneous injection is obtained under the pharmacy

benefit and is indicated in the treatment of rheumatoid arthritis

and giant cell arteritis”

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 only to Actemra (tocilizumab) injection for intravenous

infusion for the treatment of rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome. Actemra for self-administered subcutaneous injection is obtained under the pharmacy benefit and is indicated in the treatment of rheumatoid

arthritis and giant cell arteritis. Actemra is proven and medically necessary for the treatment of: Polyarticular juvenile idiopathic arthritis when ALL of the

following criteria are met:

o Diagnosis of polyarticular juvenile idiopathic arthritis (PJIA); and o 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): 10mg/kg every 4 weeks for patients weighing < 30kg 8mg/kg every 4 weeks for patients weighing ≥ 30kg;

and o Patient is not receiving Actemra in combination with either of the

following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g.,

Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

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

Rheumatoid arthritis when ALL of the following criteria are met:

o Diagnosis of moderate to severely active rheumatoid arthritis (RA); and

o History of failure, contraindication, or intolerance to at least one non-biologic DMARD [e.g., methotrexate, leflunomide, sulfasalazine,

hydroxychloroquine, minocycline, etc.]; and o Actemra is initiated and titrated according to US Food and Drug

Administration labeled dosing for rheumatoid arthritis up to a



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UPDATED

Actemra® (Tocilizumab) Injection for

Intravenous Infusion (continued)

Apr. 1, 2018 maximum of 800mg every 4 weeks (or equivalent dose and interval schedule); and

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

following: Biologic DMARD [e.g., Enbrel (etanercept), Humira

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


Systemic juvenile idiopathic arthritis when ALL of the following criteria are met:

o Diagnosis of systemic juvenile idiopathic arthritis (SJIA); and o 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): 12mg/kg every 2 weeks for patients weighing < 30kg 8mg/kg every 2 weeks for patients weighing ≥ 30kg;

and o Patient is not receiving Actemra in combination with either of the

following: Biologic DMARD [e.g., Enbrel (etanercept), Humira

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

Cytokine release syndrome when ALL of the following criteria are met: o Diagnosis of chimeric antigen receptor (CAR) T cell-induced cytokine

release syndrome (CRS); and o Actemra is prescribed according to US Food and Drug Administration

labeled dosing for CRS:

12mg/kg for patients weighing < 30kg

8mg/kg for patients weighing ≥ 30kg; up to a maximum of 800mg per infusion

and o Actemra is prescribed for a maximum of 4 doses

Balloon Sinus Ostial Dilation

Apr. 1, 2018

Updated list of applicable CPT codes; added 31298

Balloon sinus ostial dilation is proven and/or medically necessary for treating Chronic Rhinosinusitis (defined as rhinosinusitis lasting longer than 12 weeks) when all of the following are met:

Chronic Rhinosinusitis of the sinus to be dilated is confirmed on computed tomography (CT) scan. CT scan findings of Chronic



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UPDATED

Balloon Sinus Ostial Dilation (continued)

Apr. 1, 2018 Rhinosinusitis include one or more of the following: o Mucosal thickening, o Bony remodeling,

o Bony thickening, or o Obstruction of the ostiomeatal complex.

Balloon sinus ostial dilation is limited to the frontal, maxillary or sphenoid

sinuses. Balloon sinus ostial dilation is performed either as a stand-alone

procedure or as part of Functional Endoscopic Sinus Surgery (FESS). Balloon sinus ostial dilation is performed in persons whose symptoms

persist despite medical therapy with one or more of the following: o Nasal lavage o Antibiotic therapy, if bacterial infection is suspected o Intranasal corticosteroids

Balloon sinus ostial dilation is unproven and/or not medically

necessary for treating nasal polyps or tumors. There is insufficient published clinical evidence to conclude that balloon sinus

ostial dilation is safe and effective for treating nasal polyps or tumors.

Blepharoplasty, Blepharoptosis and Brow Ptosis Repair

Apr. 1, 2018 Updated supporting information; replaced reference to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care

Guidelines, 22nd edition, 2018”

Refer to the policy for complete details on the coverage guidelines for Blepharoplasty, Blepharoptosis and Brow Ptosis Repair.

Breast Reduction Surgery

Apr. 1, 2018

Updated supporting information; replaced reference to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care


Indications for Coverage

Criteria for a Coverage Determination as Reconstructive

Breast reduction surgery is considered reconstructive and medically

necessary when the following criteria are met and a physiologic

functional impairment is identified: Macromastia is the primary etiology of the member’s functional

impairment or impairments (as defined in the Definitions section of the policy). The following are examples of functional impairments that must be attributable to Macromastia to be considered (not an all-inclusive list):

o Severe skin excoriation/intertrigo unresponsive to medical management

o Severe restriction of physical activities that meets the definition of functional impairment

o Signs and symptoms of nerve compression that are unresponsive to



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UPDATED

Breast Reduction Surgery (continued)

Apr. 1, 2018

medical management, e.g., ulnar paresthesias o Acquired kyphosis that is attributed to Macromastia o Chronic breast pain due to weight of the breasts

o Upper back, neck, or shoulder pain o Shoulder grooving from bra straps o Headache

and The amount of tissue to be removed plots above the 22nd percentile; or If the amount of tissue to be removed plots between the 5th and 22nd

percentiles, the procedure may be either reconstructive or cosmetic; the

determination is based on the review of the information provided; and The proposed procedure is likely to result in significant improvement of

the functional impairment.

The Following Documentation Should be Available for Review

Reduction Mammoplasty documentation should include the evaluation and management note for the date of service and the note for the day the

decision to perform surgery was made. The member’s medical record must contain, and be available for review on request, the following information:

Height and weight Body Surface Area (BSA) Photographs that document Macromastia 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 member

specific benefit plan documents. Cosmetic Procedures are excluded from coverage. Procedures that

correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve

such consequences or behavior) as a reconstructive procedure. Any procedure that does not meet the reconstructive criteria above in

the Indications for Coverage section, e.g., psychological or social reasons, breast size asymmetry unless post mastectomy, exercise.

Breast reduction surgery is cosmetic when done to improve appearance



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UPDATED


Apr. 1, 2018

without improving a functional/physiologic impairment. The use of liposuction as the sole procedure for breast reduction surgery

is considered cosmetic.

Appendix

This Schnur chart may be used to assess whether the amount of tissue (per breast) that will be removed is reasonable for the body habitus, and whether the procedure is cosmetic or reconstructive in nature. If the amount plots above the 22nd percentile and the member has a

functional impairment, the procedure is reconstructive. If the amount plots below the 5th percentile, the procedure is cosmetic. If the amount plots between the 5th and 22nd percentiles, the procedure

may be either reconstructive or cosmetic based on review of information. To calculate body surface area (BSA), see: http://www.calculator.net/body-surface-area-calculator.html or BSA = (W 0.425 x H 0.725) x 0.007184 (weight is in kilograms and height is

in centimeters). Modified Schnur Nomogram Chart

Body Surface (m2) Lower 5th Percentile Lower 22nd Percentile

1.35 127 199

1.40 139 218

1.45 152 238

1.50 166 260

1.55 181 284

1.60 198 310

1.65 216 338

1.70 236 370

1.75 258 404

1.80 282 441

1.85 308 482

1.90 336 527

1.95 367 575

http://www.calculator.net/body-surface-area-calculator.html

http://www.calculator.net/body-surface-area-calculator.html



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UPDATED


Apr. 1, 2018 2.00 401 628

2.05 439 687

2.10 479 750

2.15 523 819

2.20 572 895

2.25 625 978

2.30 682 1,068

2.35 745 1,167

2.40 814 1,275

2.45 890 1,393

2.50 972 1,522

2.55 1,062 1,662

Cytological

Examination of Breast Fluids for Cancer Screening

Apr. 1, 2018

Updated supporting information;

replaced reference to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care


Breast ductal lavage is unproven and not medically necessary for use

in breast cancer screening of either low-risk or high-risk women. There is inadequate clinical evidence that breast ductal lavage either allows for better clinical decision-making or reduces breast cancer mortality. Further

studies are necessary to determine the efficacy of cytological examination of ductal fluid in detecting atypical cells to identify women at increased risk of breast cancer as well as comparing the results to established methods of detecting and diagnosing breast cancer. Ductal lavage is intended for use in high-risk women but no definite patient selection criteria for ductal lavage of the breast have been established.

Breast ductal fluid aspiration and cytology is unproven and not medically necessary for use in breast cancer screening of either low-

risk or high-risk women. There is inadequate clinical evidence that automated nipple aspiration either allows for better clinical decision-making or reduces breast cancer mortality. Further studies are necessary to determine the efficacy of cytological

examination of ductal fluid in detecting atypical cells to identify women at increased risk of breast cancer as well as comparing the results to established methods of detecting and diagnosing breast cancer. Fiberoptic ductoscopy, with or without ductal lavage, is unproven and not medically necessary for use in breast cancer diagnosis or



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UPDATED

Cytological Examination of Breast Fluids for

Cancer Screening (continued)

Apr. 1, 2018 screening or as an intraoperative tool to guide surgery. There is insufficient clinical evidence demonstrating that fiberoptic ductoscopy allows for better clinical decision-making, reduces breast cancer

mortality or serves as a useful adjunct to or replacement of open surgical excision.

Epidural Steroid and Facet Injections for Spinal Pain

Mar. 1, 2018

Updated coverage rationale; replaced language indicating: o “[The listed services] are

proven and medically necessary” with “[the listed

services] are proven and/or medically necessary”

o “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven and/or not medically

necessary” Updated supporting information

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

Note: Epidural steroid injections in this policy apply to the lumbar spine only. This section does not address cervical or thoracic injections. The facet joint injections section of the policy addresses multiple sites, and is

not limited to the lumbar spine. Ultrasound Guidance

The use of ultrasound guidance for epidural steroid injection(s) and facet joint injection(s) is unproven and/or not medically necessary. There is insufficient clinical evidence regarding its safety and/or efficacy in published peer-reviewed medical literature.

Epidural Steroid Injections

Epidural steroid injection is proven and/or medically necessary for treating acute and sub-acute sciatica or radicular pain of the low

back caused by spinal stenosis, disc herniation or degenerative changes in the vertebrae.

Epidural steroid injections have a clinically established role in the short-term

management of low back pain when the following two criteria are met: The pain is associated with symptoms of nerve root irritation and/or low

back pain due to disc extrusions and/or contained herniations; and The pain is unresponsive to conservative treatment, including but not

limited to pharmacotherapy, exercise or physical therapy.

Epidural steroid injection is unproven and/or not medically necessary for ALL other indications of the lumbar spine. There is a lack of evidence from randomized controlled trials indicating that epidural steroid injections effectively treat patients with lumbar pain not associated with sciatica or radicular pain. Note: This policy does not apply to obstetrical epidural anesthesia utilized

during labor and delivery.



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Epidural Steroid and Facet Injections for

Spinal Pain (continued)

Mar. 1, 2018

Facet Joint Injections

Diagnostic facet joint injection and/or facet nerve block (e.g., medial branch block) is proven and/or medically necessary when used to

localize the source of pain to the facet joint in persons with spinal pain.

Therapeutic facet joint injection is unproven and/or not medically necessary for treating chronic spinal pain. Clinical evidence about the very existence of facet joint syndrome is

conflicting, and evidence from studies is inadequate regarding the superiority of periodic facet joint injections compared to placebo in relieving chronic spinal pain (pain lasting more than 3 months). For additional information on facet joint injections as a diagnostic procedure prior to radiofrequency ablation, see the Clinical Evidence section of the policy.

Fecal Calprotectin Testing

Mar. 1, 2018 Updated non-coverage rationale; replaced language indicating “fecal measurement of calprotectin is unproven and not medically necessary” with “fecal measurement of calprotectin is unproven and/or not medically

necessary” Updated supporting information

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

Fecal measurement of calprotectin is unproven and/or not medically necessary for the diagnosis and management of all conditions, including but not limited to the following: Inflammatory bowel disease (IBD) including ulcerative colitis

(UC) and Crohn's disease (CD) Colorectal cancer (CRC)

There is insufficient evidence that fecal calprotectin (FC) is effective as a biomarker for the diagnosis and management of intestinal disease. Before FC can be incorporated into routine clinical practice, studies in larger and diverse groups of patients will be needed to further clarify its role in clinical decision making and its effect on the outcome of treatment of the condition

for which it is being used.

Glaucoma Surgical

Treatments

Apr. 1, 2018

Updated coverage rationale;

replaced language indicating: o “[The listed services] are

proven and medically necessary” with “[the listed services] are proven and/or medically necessary”

o “[The listed services] are

Glaucoma drainage devices, such as the ExPRESS™ mini glaucoma

shunt, Molteno implant, Baerveldt tube shunt, Krupin Eye Valve, or the Ahmed glaucoma valve implant, are proven and/or medically necessary for treating refractory glaucoma when conventional medical or surgical treatments have failed or are inappropriate. The iStent® Trabecular Micro-Bypass Stent System is proven and/or medically necessary when used in combination with cataract surgery



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UPDATED

Glaucoma Surgical Treatments (continued)

Apr. 1, 2018 unproven and not medically necessary” with “[the listed services] are unproven

and/or not medically necessary”

Updated list of applicable CPT

codes; revised description for 66180

Updated supporting information to reflect the most current

description of services, clinical evidence, FDA information, and references

for treating mild to moderate open-angle glaucoma and a cataract in adults currently being treated with ocular hypotensive medication.

The CyPass® Micro-Stent System is unproven and/or not medically necessary when used in combination with cataract surgery for treating mild-to-moderate primary open-angle glaucoma (POAG).

The Xen® Glaucoma Treatment System is unproven and/or is not medically necessary for treating refractory glaucoma when conventional medical or surgical treatments have failed, or in

patients with primary open-angle glaucoma, pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy. Glaucoma drainage devices, such as Eyepass, DeepLight SOLX® Gold Shunt and other shunts that do not have FDA approval are

investigational and unproven and/or not medically necessary for treating glaucoma.

Clinical evidence is limited to small studies; therefore, additional studies are needed to establish the safety and efficacy of these devices. Canaloplasty is proven and/or medically necessary for the treatment of primary open-angle glaucoma.

Viscocanalostomy is unproven and/or not medically necessary for treating glaucoma. Evidence from the majority of available randomized controlled trials indicates that viscocanalostomy is not as effective as trabeculectomy in reducing intraocular pressure (IOP).

Home Hemodialysis

Mar. 1, 2018

Updated and reorganized

coverage rationale; replaced language indicating “[the listed services] are medically necessary” with “[the listed services] are proven and/or medically necessary”

Updated supporting information

to reflect the most current description of services, clinical

Home hemodialysis without professional staff assistance is proven

and/or medically necessary as an alternative to facility-based hemodialysis for treating patients with end-stage renal disease who meet ALL of the following criteria: Patient is stable on dialysis with no evidence of complex skilled

interventions being necessary during treatments; and Patient or non-professional caregiver has the ability to perform and

maintain home hemodialysis and has received comprehensive training

regarding proper protocol; and Absence of complications and significant concomitant disease that would



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UPDATED

Home Hemodialysis (continued)

Mar. 1, 2018 evidence, FDA information, and references

cause home hemodialysis to be unsafe or unsuitable; and Presence of well-functioning vascular access.

Home hemodialysis with professional staff assistance is proven and/or medically necessary as an alternative to facility-based hemodialysis for treating patients with end-stage renal disease who

meet ALL of the following criteria: Patient is stable on dialysis and not at increased risk as a result of

having the procedure performed outside a dialysis center venue; and Patient has well-functioning vascular access; and

Patient has medical contraindications to leaving home for hemodialysis; and

Patient or non-professional caregiver is not capable of performing home hemodialysis; and

Staff assisted home hemodialysis protocols generally match those provided in the hemodialysis center (i.e., at least 3 times per week, 3-4

hour treatments). The exact dialysis therapy employed is determined on an individual basis by the attending nephrologist.

Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital

Outpatient Facility Infusion

Apr. 1, 2018

Updated coverage rationale; added reference link to the policy titled Immune Globulin (IVIG and SCIG) for proven and/or medically necessary

clinical uses of immune globulin (relocated from the Clinical Evidence section of the policy)

Updated supporting information to reflect the most current references

o Replaced reference to

“MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”

Clinical use of Immune Globulin is proven and/or medically necessary, in accordance with the Oxford policy titled Immune Globulin (IVIG and SCIG). This guideline addresses the criteria for consideration of allowing hospital

outpatient facility infusion service for Immune Globulin (IVIG and SCIG) therapy. In accordance with CMS, this includes hospital based services with either of the following Place of Service (POS) codes: 19 (Off-Campus - Outpatient Hospital) 22 (On-Campus - Outpatient Hospital)

Criteria and Clinical Indications for Hospital Outpatient Site of Care Selection

Criteria

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

Clinical Indications

Initial infusion of Immune Globulin, or re-initiation of therapy after more



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UPDATED

Immune Globulin Site of Care Review Guidelines for

Medical Necessity of Hospital Outpatient Facility

Infusion (continued)

Apr. 1, 2018 than 6 months off of Immune Globulin Change of Immune gGobulin products History of severe adverse events to Immune Globulin (including but not

limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure)

Patient is clinically unstable

Episodes of moderate to severe adverse events that have not been responsive to acetaminophen, steroids, diphenhydramine, fluids, infusion rate reductions, or other therapy pre-medications, thereby increasing risk to the patient when administration is in the home or office setting

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

health risk due to a clinically significant physical or cognitive impairment Note: If more than one of the above criteria are met, then the greatest of the applicable approval time periods will be allowed.

Orencia®

(Abatacept) Injection for Intravenous Infusion

Mar. 1, 2018


to reflect the most current references; no change to coverage rationale or lists of applicable codes

This policy refers to Orencia (abatacept) injection for intravenous infusion.

Orencia is proven and medically necessary for the treatment of: Polyarticular juvenile idiopathic arthritis when all of the following

criteria are met: o Diagnosis of moderately to severely active polyarticular juvenile

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

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

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

and o Member is not receiving Orencia in combination with either of the

following: Biologic disease-modifying antirheumatic drug (DMARD) [e.g.,

Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]


Rheumatoid arthritis when all of the following criteria are met:



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UPDATED

Orencia® (Abatacept) Injection for

Intravenous Infusion (continued)

Mar. 1, 2018 o Diagnosis of moderately to severely active rheumatoid arthritis; and o Orencia is initiated and titrated according to US Food and Drug

Administration labeled dosing for rheumatoid arthritis up to a

maximum of (or equivalent dose and interval schedule): 500mg every 4 weeks for patients weighing <60kg 750mg every 4 weeks for patients weighing 60kg to 100kg

1,000mg every 4 weeks for patients weighing >100kg and

o Member is not receiving Orencia in combination with either of the following:

Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Psoriatic arthritis when all of the following criteria are met:

o Diagnosis of active psoriatic arthritis (PsA); and

o Orencia is initiated and titrated according to US Food and Drug Administration labeled dosing for psoriatic arthritis up to a maximum

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

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

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


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

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



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Outpatient Physical & Occupational Therapy for Self-

Funded Groups

Mar. 1, 2018

Updated coverage rationale: o Removed reference link to

policy titled Complementary

and Alternative Medicine (CAM) Contracted Rate Program

o Added reference link to the Oxford Complementary and Alternative Medicine (CAM) Contracted Rate Program

webpage o Modified list of CAM

providers: Added “Chiropractors” Replaced:

- “Dieticians and

nutritional counselors” with

“Nutritionists” - “Naturopathic

physicians” with “Naturopaths”

All Citigroup (CI3198) or Brooks Brothers (BB1627) Products

Oxford covers medically necessary Physical and Occupational Therapy services. Coverage is for acute conditions only whereby services must begin within six months of the later to occur: The date of the injury or illness that caused the need for therapy

The date the Member is discharged from a hospital where surgical treatment is rendered, or

The date outpatient surgical care was rendered In no event will the therapy continue beyond 365 days after such event.* (*Long-term rider may alter coverage criteria)

Services must be performed by a duly licensed and certified provider. All services must be within the scope of the provider's license in order to be eligible for reimbursement. Up to three (3) modalities/therapeutic procedures will be accepted, without

additional documentation, per date of service. Services in excess of three (3) modalities/therapeutic procedures will be reviewed upon receipt of clinical

documentation. Referral Requirements

Oxford Members enrolled on gated self-funded groups are required to have a referral for all in-network physical or Occupational Therapy services. Members enrolled in non-gated products are not required to have a referral.

Referrals can be issued by the following: Member's PCP, General

Surgeon, Gynecological Oncologist, Hematologist-Oncologist, Neurologist, Oncologist, Orthopedists, Pain Management Specialist,

Physiatrist, Neurosurgeon, Rheumatologist. Exception: In the case of Long-Term Physical Therapy (Long-Term Physical Therapy rider required), the referral must come from the Member's PCP.

For All Oxford Self-Funded Products

Reminder: The following guidelines do not apply to Citigroup (CI3198) or

Brooks Brothers (BB1627). Oxford has delegated certain administrative services related to Physical and



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UPDATED


Funded Groups (continued)

Mar. 1, 2018

Occupational Therapy services to OptumHealth Care Solutions. OptumHealth Care Solutions, a UnitedHealth Group company, will administer the Physical and Occupational Therapy benefit for Oxford products. OptumHealth Care

Solutions is a leading physical medicine company that has significant experience working with Physical and occupational therapists and physicians, in promoting high quality, affordable physical medicine and rehabilitation

services. You may access OptumHealth Care Solutions clinical policies at the following website: https://www.myoptumhealthphysicalhealth.com.

Services managed by OptumHealth Care Solutions include: Utilization Review functions for a designated list of CPT and HCPCS codes

for outpatient Physical and Occupational Therapy for fully insured commercial products, excluding self-funded Members.

First level administrative, Utilization Management Member and provider

appeals, Member appeals, and external appeals where applicable.

Note: Oxford has not delegated 2nd level Member internal appeals, external Member appeals, and regulatory inquiries to OptumHealth Care Solutions. This policy applies to a specific list of CPT and HCPCS codes, regardless of the specialty of the treating provider. Refer to the Applicable Codes section

of the policy for a list of the CPT and HCPCS codes. Exception: If a chiropractor provides any of the services specified by the CPT or HCPCS codes in this policy, those services will continue to accrue separately towards the chiropractic benefit, if available. For chiropractic services refer to Manipulative Therapy policy for additional information.

This policy applies in the outpatient setting only. The outpatient setting for Physical Therapy and Occupational Therapy includes hospital outpatient treatment facilities, outpatient facilities at or affiliated with rehabilitation hospitals. Physical and Occupational Therapy provided in the home will be managed

under the home care benefit (per the Member's certificate). All home care services require precertification. Refer to the Home Health Care policy for additional information.

https://www.myoptumhealthphysicalhealth.com/



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Mar. 1, 2018

In the case of Occupational Therapy, the referral must come from one of the following: The Member's primary care provider (PCP)

General surgeon Gynecological oncologist Hematologist oncologist

Neurologist Oncologist Orthopedist Physiatrist

Neurosurgeon Pain management specialist or rheumatologist Refer to the Referrals policy for additional information. In-Network Subsequent Physical and Occupational Therapy

In-Network subsequent Physical and Occupational Therapy (not rendered by

a chiropractor) requires utilization review by OptumHealth Care Solutions to determine medical necessity. An initial evaluation report must be submitted

to OptumHealth Care Solutions within ten calendar days of the initial visit or prior to the second visit, whichever occurs first. All services rendered by UnitedHealthcare Choice Plus providers in the service area will be subject to retrospective review. Out-Of-Network Physical and Occupational Therapy

OptumHealth Care Solutions will review out-of-network Physical and

Occupational Therapy services for medical necessity after the services have been received and the claims are submitted.

Members also have the option through a Voluntary Prior Approval Process to submit a treatment plan. The prior approval process is completely voluntary. Out-of-Network providers are not required to pre-authorize services. All initial evaluations and subsequent visits must be authorized when using the

Voluntary Prior Approval Process. Members are financially responsible for all out-of-network services determined to be not medically necessary.



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UPDATED



Mar. 1, 2018 Note: For chiropractic services, refer to the policy titled Manipulative Therapy

for additional information.

For services provided by complementary and alternative medicine (CAM) providers, refer to Complementary and Alternative Medicine (CAM) Contracted Rate Program. CAM providers include:

o Acupuncturists o Chiropractors o Nutritionists o Massage therapists

o Naturopaths(CT only - due to state licensing statutes) o Yoga instructors

For rehabilitation services for the treatment of autism, refer to the policy titled Autism.

Utilization management and prior approval will continue to be subject to Member's certificate of coverage.

Services must be performed by a duly licensed and certified provider. All services must be within the scope of the provider's license in order to be

eligible for reimbursement.

Outpatient Physical and Occupational Therapy (OptumHealth Care

Solutions Arrangement)

Mar. 1, 2018

Updated list of related policies; removed reference link to policy titled Complementary and Alternative Medicine (CAM)

Contracted Rate Program Updated coverage rationale:

o Removed reference link to policy titled Complementary and Alternative Medicine (CAM) Contracted Rate

Program

o Added reference link to the Oxford Complementary and Alternative Medicine (CAM) Contracted Rate Program webpage

o Modified list of CAM providers:

Added “Chiropractors” Replaced:

Oxford has delegated certain administrative services related to Physical and Occupational Therapy services to OptumHealth Care Solutions. OptumHealth Care Solutions, a UnitedHealth Group company, will administer the Physical and Occupational Therapy benefit for Oxford products. OptumHealth Care

Solutions is a leading physical medicine company that has significant experience working with physical and occupational therapists and physicians, in promoting high quality, affordable physical medicine and rehabilitation services. You may access OptumHealth Care Solutions clinical policies at the following

website: https://www.myoptumhealthphysicalhealth.com.

Services managed by OptumHealth Care Solutions include: Utilization Review functions for a designated list of CPT and HCPCS codes

for outpatient Physical and occupational Therapy for fully insured commercial products, excluding self-funded Members. Exceptions: This policy does not apply to:

o New Jersey Small plans (included in OptumHealth Care Solutions arrangement, but excluded from this policy). Refer to Physical,

https://www.myoptumhealthphysicalhealth.com/



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UPDATED

Outpatient Physical and Occupational Therapy

(OptumHealth Care Solutions Arrangement)

(continued)

Mar. 1, 2018

- “Dieticians and nutritional counselors” with

“Nutritionists” - “Naturopathic

physicians” with

“Naturopaths”

Occupational (OptumHealth Care Solutions Arrangement) and Speech Therapy including Cognitive/Neuropsychological Rehabilitation for New Jersey Small Group Members.

o Self-Funded Groups refer to the Outpatient Physical & Occupational Therapy for Self-Funded Groups policy for additional information.

First level administrative, Utilization Management Member and provider appeals, Member appeals, and external appeals where applicable.

Note: Oxford has not delegated 2nd level Member internal appeals,

external Member appeals, and regulatory inquiries to OptumHealth Care Solutions.

This policy applies to a specific list of CPT and HCPCS codes, regardless of the specialty of the treating provider. Refer to the Applicable Codes section of the policy for a list of the CPT and HCPCS codes.

Exception: If a chiropractor provides any of the services specified by the

CPT or HCPCS codes in this policy, those services will continue to accrue separately towards the chiropractic benefit, if available. For chiropractic services refer to Manipulative Therapy policy for additional information.

This policy applies in the outpatient setting only. The outpatient setting for

Physical Therapy and Occupational Therapy includes hospital outpatient treatment facilities, outpatient facilities at or affiliated with rehabilitation hospitals. Physical and Occupational Therapy provided in the home will be managed under the home care benefit (per the Member's certificate). All home care

services require precertification. Refer to the Home Health Care policy for

additional information. In the case of Occupational Therapy, the referral must come from one of the following: General surgeon Gynecological oncologist

Hematologist-oncologist Neurologist Neurosurgeon



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(continued)

Mar. 1, 2018

Oncologist Orthopedists Pain management specialist or rheumatologist

Physiatrist Primary Care Provider (PCP)

Refer to the Referrals policy for additional information. In-Network Subsequent Physical and Occupational Therapy

In-Network subsequent physical and Occupational Therapy (not rendered by a chiropractor) requires utilization review by OptumHealth Care Solutions to determine medical necessity. An initial evaluation report must be submitted

to OptumHealth Care Solutions within ten calendar days of the initial visit or prior to the second visit, whichever occurs first. All services rendered by UnitedHealthcare Choice Plus providers in the service area will be subject to retrospective review.

Out-of-Network Physical and Occupational Therapy

OptumHealth Care Solutions will review out-of-network physical and Occupational Therapy services for medical necessity after the services have

been received and the claims are submitted. Members also have the option through a Voluntary Prior Approval Process to submit a treatment plan. The prior approval process is completely voluntary. Out-of-network providers are not required to pre-authorize services. All initial evaluations and subsequent visits must be authorized when using the

Voluntary Prior Approval Process.

Members are financially responsible for all out-of-network services determined to be not medically necessary. Notes: For chiropractic services refer to the Manipulative Therapy policy for

additional information. For services provided by complementary and alternative medicine (CAM)

providers, refer to Complementary and Alternative Medicine (CAM) Contracted Rate Program. CAM providers include: o Acupuncturists



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(continued)

Mar. 1, 2018 o Chiropractors o Nutritionists o Massage therapists

o Naturopaths (CT only - due to state licensing statutes) o Yoga instructors

For rehabilitation services for the treatment of Autism, refer to the

Autism policy. Utilization management and prior approval will continue to be subject to

Member's certificate of coverage. Services must be performed by a duly licensed and certified provider. All

services must be within the scope of the provider's license in order to be eligible for reimbursement.

Panniculectomy and Body Contouring Procedures

Apr. 1, 2018

Updated supporting information; replaced reference to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”


Panniculectomy

Panniculectomy is considered reconstructive and medically

necessary when ALL of the following criteria have been met:

Panniculus must hang below symphysis pubis; The Panniculus is the primary cause of skin conditions when present,

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

There is presence of a Functional Impairment (interference with activities

of daily living) due to the Panniculus; The surgery is expected to restore or improve the Functional

Impairment. Notes: After significant weight loss unrelated to bariatric surgery, in addition to

the criteria listed above, there must be documentation that a stable

weight has been maintained for six months. After significant weight loss following bariatric surgery, in addition to

meeting the criteria listed above, there must be documentation that a stable weight has been maintained for six months. This often occurs 12-18 months after surgery.

Panniculectomy is not considered reconstructive or medically

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

reduction of redundant skin and tissue results in less spinal stress or



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Panniculectomy and Body Contouring

Procedures (continued)

Apr. 1, 2018

improved posture/alignment. When performed in conjunction with abdominal or gynecologic surgery

including but not limited to hernia repair, obesity surgery, C-section and

hysterectomy unless the member meets the criteria for Panniculectomy as stated above in this document.

Performed post childbirth in order to return to pre pregnancy shape.

Performed for intertrigo, a superficial inflammatory response or any other condition that does not meet the criteria above in this document.

Documentation may be requested as part of the review, including but not

limited to photographs and physician office notes. Abdominoplasty

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

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

Suction-Assisted Lipectomy of the Trunk

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

Some states require benefit coverage for services that Oxford Health Plans considers cosmetic procedures, such as repair of external congenital

anomalies in the absence of a Functional Impairment. Please refer to the member specific benefit plan document. Cosmetic Procedures are excluded from coverage. Procedures that

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



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Panniculectomy and Body Contouring

Procedures (continued)

Apr. 1, 2018 avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or behavior) as a reconstructive procedure.

Any procedure that does not meet the reconstructive criteria above in the Indications for Coverage section of the policy.

Rhinoplasty and Other Nasal Surgeries

Apr. 1, 2018

Updated supporting information; replaced reference to “MCG™ Care Guidelines, 21st edition,

2017” with “MCG™ Care Guidelines, 22nd edition, 2018”


Some states require benefit coverage for services that Oxford considers cosmetic procedures, such as repair of external Congenital Anomalies in the absence of a Functional Impairment. Please refer to member specific benefit plan document.

Rhinoplasty-Primary (CPT 30410, 30420)

Rhinoplasty-primary is considered reconstructive and medically necessary when all of the following criteria are present: Prolonged, persistent obstructed nasal breathing due to nasal bone and

septal deviation that are the primary causes of an anatomic Mechanical

Nasal Airway Obstruction, and The nasal airway obstruction cannot be corrected by septoplasty alone

as documented in the medical record, and

Photos clearly document the nasal bone/septal deviation as the primary cause of an anatomic Mechanical Nasal Airway Obstruction and are consistent with the clinical exam, and

The proposed procedure is designed to correct the anatomic Mechanical Nasal Airway Obstruction and relieve the nasal airway obstruction by centralizing the nasal bony pyramid (30410) and also straightening the

septum (30420), and One of the following is present:

o Nasal fracture with nasal bone displacement severe enough to cause

nasal airway obstruction, or o Residual large cutaneous defect following resection of a malignancy

or nasal trauma, and Nasal airway obstruction is causing significant symptoms (e.g., chronic

rhinosinusitis, difficulty breathing), and Obstructive symptoms persist despite conservative management for 4

weeks or greater, which includes, where appropriate, nasal steroids or immunotherapy.

Rhinoplasty-Tip (CPT 30400)



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(continued)

Apr. 1, 2018

Rhinoplasty-tip is primarily cosmetic. However, it is considered reconstructive and medically necessary when all of the following criteria are present:

Prolonged, persistent obstructed nasal breathing due to tip drop that is the primary cause of an anatomic Mechanical Nasal Airway Obstruction (this code is usually cosmetic), and

Photos clearly document tip drop as the primary cause of an anatomic Mechanical Nasal Airway Obstruction and are consistent with the clinical exam (acute columellar-labial angle), and

The proposed procedure is designed to correct the anatomic Mechanical

Nasal Airway Obstruction and relieve the nasal airway obstruction by lifting the nasal tip, and

Nasal airway obstruction is causing significant symptoms (e.g., chronic rhinosinusitis, difficulty breathing), and

Obstructive symptoms persist despite conservative management for 4 weeks or greater, which includes, where appropriate, nasal steroids or

immunotherapy. Rhinoplasty-Secondary (CPT 30430, 30435, 30450)

Rhinoplasty-secondary is primarily cosmetic. However, it is considered reconstructive and medically necessary when all of the following criteria are present: Required as treatment of a complication/residual deformity from primary

surgery performed to address a Functional Impairment when a documented Functional Impairment persists due to the

complication/deformity (these codes are usually cosmetic), and Photos clearly document the secondary deformity/complication as the

primary cause of an anatomic Mechanical Nasal Airway Obstruction and are consistent with the clinical exam, and

The proposed procedure is designed to correct the anatomic Mechanical Nasal Airway Obstruction and relieve the nasal airway obstruction by correcting the deformity or treating the complication. (These codes are

usually cosmetic), and Nasal airway obstruction is causing significant symptoms (e.g., chronic

rhinosinusitis, difficulty breathing), and Obstructive symptoms persist despite conservative management for 4

weeks or greater, which includes, where appropriate, nasal steroids or immunotherapy.

Rhinoplasty for Congenital Anomalies (CPT 30460, 30462)



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(continued)

Apr. 1, 2018

The following are considered reconstructive and medically necessary when the following are present: Rhinoplasty is considered reconstructive when performed for a nasal

deformity associated with congenital craniofacial anomalies including, but not limited to Pierre Robin, Apert Syndrome, Fraser Syndrome, Binder Syndrome, Goldenhar Syndrome, Nasal dermoids, Tessier Nasal

Cleft (most commonly #1) or associated with a cleft lip or cleft palate. Repair of Nasal Vestibular Stenosis or Alar Collapse (CPT 30465)

Repair of nasal vestibular stenosis or alar collapse is considered reconstructive and medically necessary when all of the following criteria are present:

Prolonged, persistent obstructed nasal breathing due to internal and/or External Nasal Valve compromise (see Definitions section of the policy), and

Internal valve compromise due to collapse of the upper lateral cartilage and/or External Nasal Valve compromise due to collapse of the alar

(lower lateral) cartilage resulting in an anatomic Mechanical Nasal Airway Obstruction that is a primary contributing factor for obstructed

nasal breathing, and Photos clearly document internal and/or external valve collapse as the

primary cause of an anatomic Mechanical Nasal Airway Obstruction and are consistent with the clinical exam, and

Other causes have been eliminated as the primary cause of nasal obstruction (e.g., sinusitis, allergic rhinitis, vasomotor rhinitis, nasal

polyposis, adenoid hypertrophy, nasopharyngeal masses nasal septal deviation, turbinate hypertrophy and choanal atresia).

Septal Dermatoplasty (CPT 30620)

Septal dermatoplasty is considered reconstructive when: There is a documented Functional Impairment (e.g., obstruction, pain or

bleeding) due to diseased nasal mucosa, and The Functional Impairment will be eliminated by a skin graft. Lysis Intranasal Synechia (CPT 30560)

Lysis Intranasal Synechia is considered reconstructive when:

There is a documented Functional Impairment (e.g., obstruction, pain or bleeding) due to intranasal Synechia (adhesions/scar bands), and

The Functional Impairment will be eliminated by lysis of the Synechia.



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(continued)

Apr. 1, 2018

Rhinophyma (CPT Code 30120)

Rhinophyma is considered reconstructive and medically necessary when all of the following criteria are present:

One of the following: Prolonged, persistent obstructed nasal breathing due to rhinophyma,

or Chronic infection or bleeding unresponsive to medical management due to rhinophyma, and

Photos clearly document rhinophyma as the primary cause of an

anatomic Mechanical Nasal Airway Obstruction or chronic infection and are consistent with the clinical exam, and

The proposed procedure is designed to correct the anatomic Mechanical Nasal Airway Obstruction and relieve the nasal airway obstruction by correcting the deformity or the proposed procedure is designed to address the chronic infection.

Documentation Requirements

Rhinoplasty or other nasal surgery documentation should include the

evaluation and management note for the date of service and the note for the day the decision to perform surgery was made. The member’s medical record must contain, and be available for review on request, the following information: Physician office notes Radiologic imaging if done Photographs that document the nasal deformity

Coverage Limitations and Exclusions

Cosmetic Procedures are excluded from coverage, including but not limited to:

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.

Rhinoplasty, unless rhinoplasty criteria above are met. Any procedure that does not meet the reconstructive criteria.



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UPDATED


(continued)

Apr. 1, 2018 Rhinoplasty procedures performed to improve appearance. (Check member specific benefit plan document.)


REVISED

Abnormal Uterine Bleeding and Uterine Fibroids

Apr. 1, 2018

Revised coverage rationale: o Replaced language

indicating: “[The listed services] are


“[The listed services] are

unproven and not

medically necessary” with “[the listed services] are unproven and/or not medically necessary”

o Replaced reference to “MCG™ Care Guidelines, 21st

edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”; refer to 22nd edition for complete details

on applicable updates to the MCG™ Care Guidelines

Levonorgestrel-Releasing Intrauterine Device

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

, Liletta® or Kyleena™) are proven and/or medically

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

Uterine artery embolization (UAE) is proven and/or medically

necessary for treating symptomatic uterine fibroids for women who

do NOT wish to preserve their childbearing potential which has been documented and confirmed in the medical record. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Uterine Artery Embolization, ACG: A-0287 (AC).

Uterine artery embolization (UAE) is unproven and/or not medically necessary for treating symptomatic uterine fibroids for women who wish to preserve their childbearing potential. The effects of UAE on ovarian and uterine function and on fertility are relatively unknown. Further studies of safety and/or efficacy in published,

peer-reviewed medical literature are necessary.

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

Considerations section of the policy for potential coverage of unproven services.



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REVISED

Abnormal Uterine Bleeding and Uterine Fibroids

(continued)

Apr. 1, 2018 Laparoscopic ultrasound-guided radiofrequency ablation (e.g., Acessa™) is unproven and/or not medically necessary for treating uterine fibroids.

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

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

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

Attended Polysomnography for Evaluation of Sleep Disorders

Apr. 1, 2018

Revised coverage rationale; replaced references to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care


Home Sleep Apnea Testing (HSAT), using a portable monitor, is Medically Necessary for evaluating adults with suspected OSA. Where HSAT is indicated, an Autotitrating Positive Airway Pressure (APAP) device is an option to determine a fixed PAP pressure.

Attended full-channel nocturnal polysomnography, performed in a healthcare facility or laboratory setting, is Medically Necessary for evaluating individuals with suspected OSA when: Results of previous HSAT are negative, indeterminate or technically

inadequate to make a diagnosis of OSA; or

Patient is a child or adolescent (i.e., less than 18 years of age); or Patient is known to have one or more of the following comorbid medical

conditions that prohibits the use of a HSAT: o Significant Chronic Pulmonary Disease as defined by a forced

expiratory volume (FEV1) % predicted of <60 (Pellegrino et al., 2005)

o Progressive neuromuscular disease/neurodegenerative disorder

(examples include, but are not limited to, Parkinson’s disease, myotonic dystrophy, amyotrophic lateral sclerosis, multiple sclerosis with associated pulmonary disease, history of stroke with persistent neurological sequelae)

o Moderate to severe heart failure (New York Heart Association class III or IV)

o Body mass index (BMI) >50 (DeMaria et al., 2007; Blackstone and

Cortés, 2010) o Obesity Hypoventilation Syndrome



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REVISED

Attended Polysomnography for Evaluation of

Sleep Disorders (continued)

Apr. 1, 2018

o Documented ongoing epileptic seizures in the presence of symptoms of sleep disorder.

Also see Attended Repeat Testing section below. When a diagnosis of OSA has been excluded by appropriate clinical

assessment or has been adequately treated, attended full-channel nocturnal polysomnography, performed in a healthcare facility or laboratory setting, is Medically Necessary for evaluating symptomatic individuals suspected of having one (1) or more of the

following conditions: Periodic Limb Movement Disorder (PLMD) (not leg movements

associated with another disorder such as sleep disordered breathing) Restless Leg Syndrome (RLS)/Willis-Ekbom Disease that has not

responded to treatment Parasomnia with documented disruptive, violent or potentially injurious

sleep behavior suspicious of Rapid Eye Movement Sleep Behavior Disorder (RBD)

Narcolepsy, once other causes of Excessive Sleepiness have been ruled out by appropriate clinical assessment (also see MSLT section below)

Central Sleep Apnea Attended full-channel nocturnal polysomnography, performed in a

healthcare facility or laboratory setting is not Medically Necessary for diagnosing ANY of the following conditions: Circadian Rhythm Disorders Depression Insomnia

There is insufficient published clinical evidence that evaluation of the above

disorders with polysomnography (PSG) in the absence of symptoms of sleep disorder leads to better health outcomes. Actigraphy is not Medically Necessary for diagnosing sleep disorders. A review of the evidence does not establish the effectiveness of Actigraphy as a stand-alone tool for the diagnosis of sleep disorders. In addition,

definitive patient selection criteria for the use of Actigraphy devices for the diagnosis of sleep disorders have not been established.



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REVISED



Apr. 1, 2018

Daytime Sleep Studies

Multiple Sleep Latency Testing (MSLT) is Medically Necessary for evaluating individuals with suspected Narcolepsy when other causes of Excessive Sleepiness have been excluded by appropriate clinical assessment.

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC). Maintenance of Wakefulness Testing (MWT) is Medically Necessary for evaluating individuals whose inability to remain awake constitutes a safety issue, or for assessing response to treatment in

individuals with Narcolepsy or idiopathic Hypersomnia. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC).

Multiple Sleep Latency Testing (MSLT) and the Maintenance of Wakefulness Test (MWT) are not Medically Necessary for evaluating

OSA, Insomnia or Circadian Rhythm disorders. Available published evidence is insufficient to demonstrate improved management of these conditions through the use of MSLT. Published evidence for OSA is limited to poorly controlled studies. An abbreviated daytime sleep study (PAP-Nap), to acclimate

individuals to PAP and its delivery, is not Medically Necessary. Further results from large, prospective studies are needed to assess the clinical value of this test. Attended PAP Titration

A split-night sleep study, performed in a healthcare facility or laboratory setting, is Medically Necessary for the diagnosis and PAP titration when an individual meets the above criteria for an attended sleep study.

When a split-night sleep study is inadequate or not feasible, a full-night study, performed in a healthcare facility or laboratory setting, is Medically Necessary for PAP titration when an individual meets the above criteria for an attended full-channel nocturnal



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REVISED



Apr. 1, 2018 polysomnography and has a confirmed diagnosis of OSA. (Also see Attended Repeat Testing section below). Attended Repeat Testing

Repeat attended full-channel nocturnal polysomnography, performed in a

health care facility or laboratory setting, as well as repeat PAP titration, is Medically Necessary for certain individuals who have persistent or new symptoms, despite documented appropriate current treatment or PAP therapy (e.g., equipment failure, improper mask fit, pressure leaks, inadequate pressure and medical problems including nasal congestion have been addressed and appropriately managed).

Repeat testing and repositioning/adjustments for oral sleep appliances can be done in the home unless the patient meets criteria for an attended sleep study.

Buprenorphine (Probuphine® &

Sublocade™)

Apr. 1, 2018

Changed policy title; previously titled Probuphine®

(Buprenorphine) Revised coverage rationale:

o Added language to indicate: This policy provides

information about the use of buprenorphine formulations administered by either the subcutaneous (SC)

or by subdermal implant and refers to the following buprenorphine

products: - Probuphine® - Sublocade™

Buprenorphine extended-release injection (e.g., Sublocade) is proven and/or medically necessary for the

This policy provides information about the use of buprenorphine formulations administered by either the subcutaneous (SC) or by subdermal implant. This

policy refers to the following buprenorphine products: Probuphine®

Sublocade™ Probuphine (buprenorphine) subdermal implant is proven and/or medically necessary for the maintenance treatment of opioid dependence in patients who meet ALL of the following criteria:

Patient has achieved and sustained prolonged clinical stability on transmucosal buprenorphine; and

Patient is currently maintained on a dose of 8mg per day or less of oral, sublingual or transmucosal buprenorphine product equivalent [e.g., Subutex 8 mg or less, Suboxone (or generic equivalent) 8 mg/2 mg or

less, Bunavail 4.2 mg/0.7 mg or less, or Zubsolv 5.7 mg/1.4 mg or less]; and

Patient has been on a stable oral, sublingual or transmucosal

buprenorphine dose for six months or longer without any need for supplemental dosing or adjustments; and

Prescriber meets DATA 2000 requirements and has been assigned a unique identification number specific to the prescription of medication assisted therapy (DEA-X); and

Prescriber and/or the healthcare provider performing insertion has



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REVISED

Buprenorphine (Probuphine® & Sublocade™)

(continued)

Apr. 1, 2018

treatment of moderate to severe opioid use disorder in patients who

meet all of the following criteria:

Initial Therapy

- Patient is currently maintained on a 8mg to 24mg per day dose of oral, sublingual, or transmucosal buprenorphine

product equivalent for at least 7 days prior to initiation of extended-release

buprenorphine injection; and

- Patient has not, nor

will receive supplemental, oral, sublingual, or transmucosal buprenorphine; and

- Prescriber meets

DATA 2000 requirements and has been assigned a

unique identification number specifc to the prescription of medication assisted

therapy (DEA-X); and

- Sublocade dosing is in accordance with the U. S. Food and Drug Administration

successfully completed a live training program specific to Probuphine insertion; and

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

documenting one of the following: o Initial therapy with Probuphine when meeting all of the following:

Patient has a viable site for implant on the upper arm (inner side

of the upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus in the sulcus between the biceps and triceps muscle).

Patient will not be receiving supplemental oral, sublingual or

transmucosal buprenorphine. Patient has not had an opioid-positive urine drug screen within

the previous ninety days prior to insertion.* or

o Continuation therapy with Probuphine when meeting all of the following:

Patient has only had one Probuphine implant and has a viable, unused site in the contralateral arm.

Patient has not, nor will receive supplemental oral, sublingual, or transmucosal buprenorphine.

Probuphine is not being inserted into a previously used arm or insertion site.

Probuphine is only to be used in a maximum of 2 insertions (once

in each arm). Patient shows no evidence of tampering, extraction, or attempted

removal of the previous Probuphine implant. Patient has not had an opioid-positive urine drug screen since

starting Probuphine therapy.*

*Note: Patients screening positive for opioid use outside of an opioid

dependence treatment regimen is evidence that the patient has not achieved or is no longer in sustained, prolonged, clinical stability with their treatment program. Use of Probuphine is not indicated in this population. Patients should use sublingual or transmucosal buprenorphine until the patient can achieve sustained, prolonged, clinical stability on a low-to-moderate dose (i.e., doses of no more than 8 mg

per day of Subutex or Suboxone sublingual tablet or generic equivalent). Buprenorphine extended-release injection (e.g., Sublocade) is



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REVISED


(continued)

Apr. 1, 2018

approved labeling: 300mg subcutaneously

monthly for the first 2 months, followed by a maintenance

dose of 100 mg monthly; dosing may be increased to 300mg monthly; and

- Initial authorization will be for no more than 6 months

Continuation Therapy

- Patient has experienced treatment success to

buprenorphine extended-release therapy; and

- Patient has not, nor will receive supplemental, oral, sublingual, or transmucosal buprenorphine; and

- Prescriber meets DATA 2000 requirements and

has been assigned a unique identification number specifc to the prescription of

medication assisted therapy (DEA-X); and

- Sublocade dosing for is in accordance with the U. S. Food and

proven and/or medically necessary for the treatment of moderate to severe opioid use disorder in patients who meet ALL of the following criteria:

For initial therapy, all of the following: o Patient is currently maintained on a 8mg to 24mg per day dose of

oral, sublingual, or transmucosal buprenorphine product equivalent

for at least 7 days prior to initiation of extended-release buprenorphine injection; and

o Patient has not, nor will receive supplemental, oral, sublingual, or transmucosal buprenorphine; and

o Prescriber meets DATA 2000 requirements and has been assigned a unique identification number specific to the prescription of medication assisted therapy (DEA-X); and

o Sublocade dosing for is in accordance with the U. S. Food and Drug Administration approved labeling: 300mg subcutaneously monthly for the first 2 months, followed by a maintenance dose of 100 mg

monthly. Dosing may be increased to 300mg monthly; and o Initial authorization will be for no more than 6 months.

or For continuation therapy, all of the following::

o Patient has experienced a treatment success to buprenorphine extended-release therapy; and

o Patient has not, nor will receive supplemental, oral, sublingual, or

transmucosal buprenorphine; and o Prescriber meets DATA 2000 requirements and has been assigned a

unique identification number specific to the prescription of medication assisted therapy (DEA-X); and

o Sublocade dosing is in accordance with the U. S. Food and Drug Administration approved labeling: Maintenance dose of 100 mg

monthly. Dosing may be increased to 300mg monthly; and

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

Buprenorphine extended-release injection is unproven and/or not medically necessary for pain management. Probuphine is unproven and/or not medically necessary for:

Patients who have not achieved and sustained prolonged clinical stability and tolerance to opioids for at least six months.

Patients who are maintained on sublingual or transmucosal



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REVISED


(continued)

Apr. 1, 2018

Drug Administration approved labeling: maintenance dose of

100 mg monthly; dosing may be increased to 300mg

monthly; and - Continuation

authorization will be for no more than 12

months o Replaced language

indicating: “Probuphine

(buprenorphine) subdermal implant is

proven and medically necessary for the

maintenance treatment of opioid dependence” with “Probuphine (buprenorphine) subdermal implant is

proven and/or medically necessary for the maintenance treatment of opioid dependence”

“Probuphine is unproven and not medically

necessary for pain

management” with “Buprenorphine extended-release injection is unproven and/or not medically necessary for pain

management” “Probuphine is unproven

and not medically

buprenorphine at doses greater than 8 mg per day. Patients who are recently tapered to a lower dose of sublingual or

transmucosal buprenorphine for the sole purpose of transitioning to

Probuphine. Patients who are new entrants to opioid dependence treatment. Patients who have already had one insertion in each arm.

Patient who do not have viable sites for insertion in the upper arm. Patients who have an opioid-positive urine drug screen within the

previous ninety days. Patient is currently being treated for chronic pain requiring opioids.



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REVISED


(continued)

Apr. 1, 2018 necessary for [the listed indications]” with “Probuphine is unproven

and/or not medically necessary for [the listed indications]”

Updated list of applicable HCPCS codes; added J3490


background information, clinical evidence, FDA information, and references

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Apr. 1, 2018

Revised coverage rationale: o Replaced references to

“patient” with “individual” o Replaced language

indicating: “External insulin pumps

that deliver insulin by continuous subcutaneous infusion are proven and medically necessary for

patients with type 1 or insulin-requiring type 2 diabetes” with “external insulin pumps that deliver insulin by continuous subcutaneous

infusion are proven

and/or medically necessary for treating individuals with type 1 or insulin-requiring type 2 diabetes”

“For information regarding medical

necessity review, when applicable, see MCG™

Insulin Delivery

External insulin pumps that deliver insulin by continuous subcutaneous infusion are proven and/or medically necessary for treating individuals with type 1 or insulin-requiring type 2 diabetes.

For applicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018, Insulin Infusion Pump ACG: A-0339 (AC).

Note: Programmable disposable external insulin pumps (e.g., Omnipod) are considered clinically equivalent to standard insulin pumps. Nonprogrammable transdermal insulin delivery systems (e.g., V-Go) are unproven and/or not medically necessary for treating individuals with diabetes.

There is insufficient evidence in the clinical literature demonstrating the safety and efficacy of transdermal insulin delivery in the management of individuals with diabetes.

Implantable insulin pumps are investigational, unproven and/or not medically necessary for treating individuals with diabetes.

No implantable insulin pumps have received U.S. Food and Drug Administration (FDA) approval at this time. While some preliminary studies reported improved glycemic control and fewer episodes of hypoglycemia in carefully selected individuals, complications such as catheter blockage and infection were observed. Larger, randomized controlled trials are needed to determine the long-term impact of implantable insulin pumps on diabetes



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REVISED

Continuous Glucose Monitoring and Insulin Delivery for

Managing Diabetes (continued)

Apr. 1, 2018

Care Guidelines, 21st edition, 2017” with “for applicable clinical

coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018”; refer

to 22nd edition for complete details on applicable updates to the MCG™ Care Guidelines

“Programmable disposable external insulin pumps (e.g., Omnipod) are considered equivalent to standard insulin pumps” with

“programmable disposable external

insulin pumps (e.g., Omnipod) are considered clinically equivalent to standard insulin pumps”

“Nonprogrammable

transdermal insulin delivery systems (e.g., V-Go) are unproven and not medically necessary” with “nonprogrammable transdermal insulin

delivery systems (e.g.,

V-Go) are unproven and/or not medically necessary”

“Implantable insulin pumps are investigational, unproven

and not medically necessary” with “implantable insulin

management. Insulin infuser ports are unproven and/or not medically necessary

for insulin delivery in individuals with diabetes. There is insufficient evidence demonstrating that the use of insulin infuser ports results in improved glycemic control beyond what can be achieved by

using standard insulin delivery methods. In addition, an increase in complications, such as infection at the port site, has been reported when using these devices. Further well-designed, large-scale randomized controlled trials are needed to establish the safety and efficacy of these

devices. See the Description of Services section of the policy for further details on the various types of insulin delivery systems. Continuous Glucose Monitoring

Short-term (3-7 days) continuous glucose monitoring by a

healthcare provider for diagnostic purposes is proven and/or medically necessary for managing individuals with diabetes.

Long-term continuous glucose monitoring for personal use at home is proven and/or medically necessary for managing individuals with type 1 diabetes who have demonstrated adherence to a physician ordered diabetic treatment plan and are on an intensive insulin regimen (3 or more insulin injections per day or insulin pump

therapy). Long-term continuous glucose monitoring for personal use at home is unproven and/or not medically necessary for managing individuals

with type 2 diabetes or gestational diabetes. There is insufficient evidence that the use of long-term continuous glucose monitoring leads to improvement of glycemic control in individuals with type

2 or gestational diabetes. Continuous glucose monitoring using an implantable glucose sensor (e.g., Eversense) is investigational, unproven and/or not medically necessary for managing individuals with diabetes due to lack of U.S. Food and Drug Administration (FDA) approval. There is insufficient published clinical evidence to conclude that the use of



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REVISED



Apr. 1, 2018

pumps are investigational, unproven and/or not medically

necessary for treating individuals with diabetes”

“Insulin infuser ports are unproven and not medically necessary” with “Insulin infuser

ports are unproven and/or not medically necessary”

“Short-term (3-7 days) continuous glucose monitoring by a

healthcare provider for diagnostic purposes is

proven and medically necessary for patients with diabetes” with “short-term (3-7 days) continuous glucose

monitoring by a healthcare provider for diagnostic purposes is proven and/or medically necessary for managing individuals with

diabetes”

“Long-term continuous glucose monitoring for personal use at home is proven and medically necessary for patients with type 1 diabetes who

have demonstrated adherence to a physician ordered diabetic

continuous glucose monitoring using an implantable glucose sensor leads to an improvement in glycemic control. The small sample sized studies lack adequate controls, randomization and blinding.

Continuous glucose monitoring using a noninvasive device is investigational, unproven and/or not medically necessary for

managing individuals with diabetes due to lack of FDA approval. There are no commercially available noninvasive systems at this time. There is insufficient published clinical evidence to assess the safety and efficacy of continuous glucose monitoring using a noninvasive device.



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REVISED



Apr. 1, 2018

treatment plan” with “long-term continuous glucose monitoring for

personal use at home is proven and/or medically necessary for managing

individuals with type 1 diabetes who have demonstrated adherence to a physician ordered

diabetic treatment plan and are on an intensive insulin regimen (3 or more insulin injections per day or insulin pump therapy)”

“Long-term continuous glucose monitoring is

unproven and not medically necessary for patients with type 2 diabetes or gestational diabetes” with “long-

term continuous glucose monitoring for personal use at home is unproven and/or not medically necessary for managing individuals with type 2

diabetes or gestational

diabetes” “Continuous glucose

monitoring using an implantable glucose sensor (e.g., Eversense) is investigational,

unproven and not medically necessary” with “continuous glucose



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REVISED



Apr. 1, 2018

monitoring using an implantable glucose sensor (e.g., Eversense)

is investigational, unproven and/or not medically necessary for

managing individuals with diabetes”

“Continuous glucose monitoring using a

noninvasive device is investigational, unproven and not medically necessary” with “continuous glucose monitoring using a

noninvasive device is investigational, unproven

and/or not medically necessary for managing individuals with diabetes”

o Removed instruction to refer

to MCG™ Care Guidelines, 21st edition, 2017, Continuous Glucose Monitoring ACG:A-0126 (AC) for information regarding medical necessity review,

when applicable, for long-

term continuous glucose monitoring for personal use at home

Added list of applicable ICD-10 diagnosis codes: E11.00, E11.01, E11.10, E11.11, E11.21,

E11.22, E11.29, E11.311, E11.319, E11.3211, E11.3212, E11.3213, E11.3219, E11.3291,



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REVISED



Apr. 1, 2018 E11.3292, E11.3293, E11.3299, E11.3311, E11.3312, E11.3313, E11.3319, E11.3391, E11.3392,

E11.3393, E11.3399, E11.3411, E11.3412, E11.3413, E11.3419, E11.3491, E11.3492, E11.3493,

E11.3499, E11.3511, E11.3512, E11.3513, E11.3519, E11.3521, E11.3522, E11.3523, E11.3529, E11.3531, E11.3532, E11.3533,

E11.3539, E11.3541, E11.3542, E11.3543, E11.3549, E11.3551, E11.3552, E11.3553, E11.3559, E11.3591, E11.3592, E11.3593, E11.3599, E11.36, E11.37X1, E11.37X2, E11.37X3, E11.37X9,

E11.39, E11.40, E11.41, E11.42, E11.43, E11.44, E11.49, E11.51,

E11.52, E11.59, E11.610, E11.618, E11.620, E11.621, E11.622, E11.628, E11.630, E11.638, E11.641, E11.649, E11.65, E11.69, E11.8, E11.9,

O24.111, O24.112, O24.113, O24.119, O24.12, O24.13, O24.410, O24.414, O24.415, O24.419, O24.430, O24.434, O24.435, and O24.439


to reflect the most current

description of services and FDA information

Denosumab (Prolia® & Xgeva®)

Jun. 1, 2018

Revised conditions of coverage/authorization requirements to indicate precertification with review by a Medical Director or their

designee is required

This policy refers to the following denosumab products: Prolia Xgeva Proven

Prolia (denosumab) is proven and medically necessary for:



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REVISED


Jun. 1, 2018

The treatment of postmenopausal patients with osteoporosis, or

to increase bone mass in patients with osteoporosis at high risk

for fracture who meet ALL of the following criteria: o Diagnosis of osteoporosis; and o One of the following:

BMD T-score ≤ -2.5 based on BMD measurements from lumbar spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site); or

History of one of the following resulting from minimal trauma:

- Vertebral compression fracture - Fracture of the hip - Fracture of the distal radius - Fracture of the pelvis - Fracture of the proximal humerus or

Both of the following: - BMD T-score between -1 and -2.5 (BMD T-score greater

than-2.5 and less than or equal to -1) based on BMD measurements from lumber spine (at least two vertebral bodies), hip (femoral neck, total hip), or radius (one-third radius site); and

- One of the following:

FRAX 10-year fracture probabilities: major osteoporotic fracture at 20% or more

FRAX 10-year fracture probabilities: hip fracture at 3% or more; and

and o History of failure, contraindication, or intolerance to oral or

intravenous bisphosphonate therapy; and

o Prolia dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 60 mg every 6 months; and

o Authorization is for no more than 12 months. To increase bone mass in patients at high risk for fracture

receiving androgen deprivation therapy for non-metastatic prostate cancer in patients who meet ALL of the following criteria:



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Jun. 1, 2018

o Diagnosis of non-metastatic prostate cancer; and o Patient is receiving androgen deprivation therapy; and o History of failure, contraindication, or intolerance to oral or

intravenous bisphosphonate therapy; and o Prolia dosing is in accordance with the United States Food and Drug

Administration approved labeling: maximum dosing of 60 mg every 6

months; and o Authorization is for no more than 12 months.

To treat patients at high risk for fracture receiving adjuvant

aromatase inhibitor therapy for breast cancer in patients who meet ALL of the following criteria: o Diagnosis of breast cancer; and o Patient is receiving aromatase inhibitor therapy; and o History of failure, contraindication, or intolerance to oral or

intravenous bisphosphonate therapy; and

o Prolia dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 60 mg every 6

months; and o Authorization is for no more than 12 months.

Xgeva (denosumab) is proven and medically necessary for:

The prevention of skeletal-related events in patients with multiple myeloma and with bone metastases from solid tumors when ALL of the following criteria are met: o Patient is one of the following:

Patient is ≥ 18 years of age; or Patient is a skeletally mature adolescent as defined by having at

least 1 mature long bone (e.g., closed epiphyseal growth plate of

the humerus) and

o One of the following: Diagnosis of multiple myeloma; or Presence of metastatic disease secondary to a solid tumor (e.g.,

bladder, kidney, lung, ovarian, thyroid, etc.)

and o Individual has an expected survival of 3 months or greater; and o Refractory (within the past 30 days), contraindication (including renal



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REVISED


Jun. 1, 2018

insufficiency), or intolerance to treatment with intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid) ; and

o Xgeva dosing is in accordance with the United States Food and Drug

Administration approved labeling: maximum dosing of 120 mg every 4 weeks; and


The treatment of giant cell tumor of the bone when ALL of the

following criteria are met: o Patient is one of the following:

Patient is ≥ 18 years of age; or Patient is a skeletally mature adolescent as defined by having at

least 1 mature long bone (e.g., closed epiphyseal growth plate of the humerus)

and o Diagnosis of localized or metastatic giant cell tumor of the bone; and

o Disease is one of the following: Unresectable; or

Surgical resection is likely to result in severe morbidity and

o Xgeva dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 120 mg every 4 weeks (additional 120 mg doses allowed on Day 8 and 15 in the

first month of therapy); and o Authorization is for no more than 12 months.

The treatment of hypercalcemia of malignancy when ALL of the

following criteria are met: o Patient is one of the following:

Patient is ≥ 18 years of age; or


and o Diagnosis of hypercalcemia of malignancy as defined as: albumin-

corrected serum calcium level greater than 12.5 mg/dL (3.1

mmol/L); and o No pre-existing hypocalcemia (i.e., serum calcium or corrected

calcium within normal limits per laboratory reference); and



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REVISED


Jun. 1, 2018 o Refractory (within the past 30 days), contraindication (including renal insufficiency), or intolerance to treatment with intravenous bisphosphonate therapy (e.g., pamidronate, zoledronic acid); and

o Xgeva dosing is in accordance with the United States Food and Drug Administration approved labeling: maximum dosing of 120 mg every 4 weeks (additional 120 mg doses allowed on Day 8 and 15 in the

first month of therapy); and o Authorization is for no more than 12 months.

Unproven

Xgeva is unproven and not medically necessary for the following indications:

Combination therapy of denosumab and intravenous bisphosphonates Bone loss associated with hormone-ablation therapy (other than

aromatase inhibitors) in breast/prostate cancer Cancer pain Central giant cell granuloma

Hyper-parathyroidism Immobilization hypercalcemia

Osteogenesis imperfecta Osteopenia

Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Apr. 1, 2018 Revised list of medications requiring precertification through the pharmacy benefit manager (PBM): o Added Impoyz, Noctiva, and

Steglujan o Removed Baxdela Tablet and

Flolipid

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

Policy Title Effective Date Drug/Medication Status Summary of Changes

REVISED

Drug Coverage Guidelines

Mar. 1, 2018

Prolia, Xgeva (Denosumab)

Revised

Added language to indicate precertification is not required however it is strongly recommend precertification be requested for this medication

o While no penalty will be imposed for failure to request a pre-service review, if you do not request one, a medical necessity review will be conducted post-service to determine coverage

o It is the referring physician’s responsibility to provide medical



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REVISED

Drug Coverage Guidelines (continued)

Mar. 1, 2018 Prolia, Xgeva (Denosumab) (continued)

Revised documentation to demonstrate clinical necessity for the medication o Beginning June 1, 2018, precertification will be required

Added precertification guidelines; refer to Precertification Guidelines:

Denosumab (Prolia® & Xgeva®) for complete details Symdeko (Tezacaftor/Ivacaftor)

New Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM)

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

Drug Coverage Guidelines

Apr. 1, 2018 Arymo ER (Morphine Sulfate)

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

Avinza (Morphine Sulfate

Controlled Release) (Brand Only)

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

Authorization/Medical Necessity Guidelines: Avinza for complete details Updated drug/medication name; replaced “extended” with “controlled”

Baxdela (Delafloxacin) Revised Revised coverage criteria/precertification requirements to indicate precertification is no longer required

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

Equivalent Medications

Cabometyx (Cabozantinib)

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

Dolophine (Methadone) New Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM) Added prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Dolophine for complete details

Duragesic (Brand Only) (Fentanyl)

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

details

Embeda (Morphine Sulphate and Naltrexone HCL)

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

Entresto (Valsartan – Sacubitril)

Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Entestro (Valsartan-Sacubitril) for complete details



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REVISED


Apr. 1, 2018 Exalgo (Hydromorphone) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Exalgo for complete details

Flolipid (Simvastatin Suspension)

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

Hemlibra (Emicizumab-

Kxwh)

New Added language to indicate precertification is required through the

Pharmacy Benefit Manager (PBM)

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

Hysingla ER (Hydrocodone Bitartrate)

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

Impoyz (Clobetasol Propionate)


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

Kadian (Morphine Sulfate Extended Release)

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

Morphabond ER (Morphine Sulfate)

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

Morphine Sulfate Controlled-Release (Generic MS Contin)


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

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

Authorization/Medical Necessity Guidelines: MS Contin for complete details

Noctiva (Desmopressin Acetate)


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

Nucynta ER (Tapentadol Extended Release)

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



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REVISED


Apr. 1, 2018 Opana ER (Oxymorphone Extended Release)

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

Oxycontin (Oxycodone Extended Release)

Revised

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

Oxycodone ER 12hr

Tablet


Authorization/Medical Necessity Guidelines: Oxycodone ER for complete details

Oxymorphone Extended Release

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

Probuphine (Buprenorphine)

Updated Updated reference link to reflect title change for Precertification Guidelines: Buprenorphine (Probuphine® & Sublocade™)

Steglujan (Ertugliflozin/Sitagliptin)


Added therapeutic equivalent guidelines; refer to Therapeutic Equivalent

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

Sublocade (Buprenorphine Extended-Release)


Added precertification guidelines; refer to Precertification Guidelines: Buprenorphine (Probuphine® & Sublocade™) for complete details

Trintellix (Vortioxetine) Revised Added step therapy guidelines; refer to Step Therapy Guidelines: Trintellix for complete details

Removed prior authorization/notification guidelines and corresponding reference link to policy titled Prior Authorization/Notification Guidelines: Trintellix

Troxyca ER (Oxycodone

HCL and Naltrexone)


Authorization/Medical Necessity Guidelines: Troxyca ER for complete details

Vantrela ER (Hydrocodone Bitartrate)

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

details

Xeljanz (Tofacitinib)

Revised

Revised coverage guidelines to indicate precertification is required through the Pharmacy Benefit Manager (PBM)

Added Prior Authorization/Notification guidelines; refer to Prior Authorization/Notification Guidelines: Xeljanz for complete details

Added step therapy guidelines; refer to Step Therapy Guidelines: Xeljanz



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REVISED


Apr. 1, 2018 Xeljanz (Tofacitinib) (continued)

Revised for complete details

Xeljanz XR Revised

Revised coverage guidelines to indicate precertification is required through the Pharmacy Benefit Manager (PBM)

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

Added step therapy guidelines; refer to Step Therapy Guidelines: Xeljanz XR for complete details

Xtampza ER (Oxycodone)

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

Zohydro ER (Hydrocodone Bitartrate

Extended Release)

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

details


REVISED

Elbow Replacement

Surgery (Arthroplasty)

Apr. 1, 2018 Revised coverage rationale:

o Added language to indicate elbow replacement surgery

is proven and/or medically necessary in certain circumstances

o Replaced language indicating “for information regarding medical necessity review, when applicable, see MCG™

Care Guidelines, 21st edition, 2017” with “for applicable

clinical coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018”; refer to 22nd edition for complete details on applicable updates to the

MCG™ Care Guidelines Updated supporting information

to reflect the most current FDA information

Elbow replacement surgery is proven and/or medically necessary in certain

circumstances. For applicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018, Elbow Arthroplasty, S-420 (ISC).



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REVISED

Electrical and Ultrasound Bone Growth Stimulators

Apr. 1, 2018

Revised coverage rationale: o Replaced references to

“MCG™ Care Guidelines, 21st

edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”; refer to 22nd

edition for complete details on applicable updates to the MCG™ Care Guidelines

Two MCG™ Care Guidelines 22nd edition, 2018 are identified, one for electrical and electromagnetic bone growth stimulators, and one for ultrasonic bone growth stimulators.

For information regarding medical necessity review of electrical and electromagnetic bone growth stimulators, when applicable, see MCG™ Care

Guidelines, 22nd edition, 2018, Bone Growth Stimulators, Electrical and Electromagnetic ACG: A-0565 (AC). For information regarding medical necessity review of ultrasonic bone growth

stimulators, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Bone Growth Stimulators, Ultrasonic ACG: A-0414 (AC).

Functional Endoscopic Sinus Surgery (FESS)

Apr. 1, 2018 Revised coverage rationale; replaced language indicating “functional endoscopic sinus surgery (FESS) is medically necessary for [the listed

indications]” with “functional endoscopic sinus surgery (FESS) is proven and/or medically necessary for [the listed indications]”


codes; added 31253, 31257, and 31259

Functional Endoscopic Sinus Surgery (FESS) is proven and/or medically necessary for one or more of the following: Patients with Chronic Rhinosinusitis (defined as Rhinosinusitis lasting

longer than 12 weeks) with both of the following: o Chronic Rhinosinusitis of the sinus to be operated on is confirmed on

computed tomography (CT) scan by one or more of the following: Mucosal thickening Bony remodeling Bony thickening or Obstruction of the ostiomeatal complex Opacified sinus

o Symptoms persist despite medical therapy with one or more of the following: Nasal lavage Antibiotic therapy, if bacterial infection is suspected Intranasal corticosteroids

Mucocele documented on CT scan

Concha bullosa documented on CT scan

Complications of sinusitis such as abscess Tumor documented on CT scan (such as polyposis or malignancy) Recurrent Acute Rhinosinusitis (RARS)

Hip Resurfacing and Replacement Surgery (Arthroplasty)

Apr. 1, 2018

Revised coverage rationale; replaced references to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care


Hip Replacement Surgery (Arthroplasty)

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Hip Arthroplasty, S-560 (ISC). For information regarding medical necessity review, when applicable, see



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REVISED

Hip Resurfacing and Replacement Surgery

(Arthroplasty) (continued)

Apr. 1, 2018 MCG™ Care Guidelines, 22nd edition, 2018, Hip: Displaced Fracture of Femoral Neck, Hemiarthroplasty, S-600 (ISC). Hip Resurfacing Arthroplasty

For information regarding medical necessity review, when applicable, see

MCG™ Care Guidelines, 22nd edition, 2018, Hip Resurfacing, S-565 (ISC).

Hysterectomy for Benign Conditions

Apr. 1, 2018 Revised coverage rationale: o Replaced reference to

“MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”; refer to 22nd



references

For information regarding medical necessity review, when applicable, see the following MCG™ Care Guidelines, 22nd edition, 2018: Hysterectomy, Abdominal, ORG: S-650 (ISC) Hysterectomy, Vaginal, ORG: S-660 (ISC) Hysterectomy, Laparoscopic, ORG: S-665 (ISC)

Implanted

Electrical Stimulator for Spinal Cord

Apr. 1, 2018 Revised coverage rationale:

o Added language to indicate implanted electrical stimulator for spinal cord is proven and/or medically necessary in certain circumstances

o Replaced language indicating

“for information regarding medical necessity review,

when applicable, see MCG™ Care Guidelines, 21st edition, 2017” with “for applicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd

edition, 2018” Updated list of applicable HCPCS

codes; removed L8683

Implanted electrical stimulator for spinal cord is proven and/or

medically necessary in certain circumstances. For applicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018, Implanted Electrical Stimulator, Spinal Cord ACG: A-0243 (AC). Note: For Dorsal Root Ganglion (DRG) stimulation, please refer to the policy titled Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation.



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REVISED

Luxturna™ (Voretigene Neparvovec-Rzyl)

May 1, 2018

Revised conditions of coverage/precertification requirements to indicate

precertification with review by a Medical Director or their designee is required

Luxturna is proven and/or medically necessary for the treatment of Inherited Retinal Dystrophies (IRD) caused by mutations in the retinal pigment epithelium-specific protein 65kDa (RPE65) gene in

patients who meet ALL of the following criteria: Patient is greater than 12 months of age; and Diagnosis of a confirmed biallelic RPE65 mutation-associated retinal

dystrophy (e.g. Leber’s congenital amaurosis [LCA], Retinitis pigmentosa [RP] Early Onset Severe Retinal Dystrophy [EOSRD], etc.); and

Genetic testing documenting biallelic mutations of the RPE65 gene; and Sufficient viable retinal cells as determined by optical coherence

tomography (OCT) confirming an area of retina within the posterior pole of >100 µm thickness; and

Prescribed and administered by ophthalmologist or retinal surgeon with experience providing sub-retinal injections; and

Patient has not previously received RPE65 gene therapy in intended eye.

Molecular Oncology Testing for Cancer

Diagnosis, Prognosis, and Treatment Decisions

Apr. 1, 2018

Revised coverage rationale: o Updated list of unproven/not

medically necessary gene expression profiling assays for colorectal cancer (CRC) risk assessment or management; removed “fecal DNA testing, i.e.,

ColonSentry” o Replaced language


proven and medically necessary” with “[the

listed services] are

proven and/or medically necessary”

“[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven

and/or not medically necessary”

Gene Expression Tests for Breast Cancer Treatment

The use of one of the following gene expression tests is considered

proven and/or medically necessary to make a treatment decision regarding adjuvant chemotherapy in females or males with non-

metastatic breast cancer when all of the following criteria are met. However, the use of more than one gene expression test for the same tumor in an individual with breast cancer is unproven and/or not medically necessary. Gene Expression Tests for High Risk Breast Cancer

Gene expression tests for high risk breast cancer, including MammaPrint (also referred to as the "Amsterdam Signature" or "70-

Gene Signature"), are considered proven and/or medically necessary to assess distant recurrence of disease in individuals with recently diagnosed non-metastatic breast cancer when ALL the following criteria are met: High clinical risk of recurrence based on at least one of the following

criteria: o Lymph node positive (pN1-2); or

o Tumor size greater than 2 cm; or o Poorly differentiated or undifferentiated histology (grade 3) AND

tumor size greater than 1 cm; and



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REVISED

Molecular Oncology Testing for Cancer Diagnosis,

Prognosis, and Treatment Decisions

(continued)

Apr. 1, 2018

o Replaced reference to “patients” with “individuals”


codes; added 81520 and 81521 Updated supporting information

to reflect the most current

references

Hormone receptor-positive (estrogen receptor positive, progesterone receptor positive or both); and

HER2 receptor negative; and

Adjuvant chemotherapy is not precluded due to any other factor (e.g., advanced age and/or significant co-morbidities); and

Individual and treating physician have had a discussion prior to testing

regarding the potential results of the test and determined to use the results to guide therapy.

MammaPrint is considered unproven and/or not medically necessary

for all other indications. Gene Expression Tests for Intermediate and Low Risk Breast Cancer

Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene Signature Assay, EndoPredict and the Breast Cancer Index gene expression tests for intermediate and low risk breast cancer are considered proven and/or medically necessary to assess use of

adjuvant chemotherapy in individuals with recently diagnosed non-metastatic breast cancer when all of the following criteria are met:

Lymph node negative (pN0) or axillary lymph node micrometastasis less than 2mm (pN1mi); and

Hormone receptor positive (estrogen receptor positive, progesterone receptor positive or both); and

HER2 receptor negative; and Adjuvant chemotherapy is not precluded due to any other factor (e.g.,

advanced age and/or significant co-morbidities); and Individual and treating physician have had a discussion prior to testing

regarding the potential results of the test and determined to use the results to guide therapy.

Oncotype Dx Breast, Prosigna PAM-50 Breast Cancer Prognostic Gene Signature Assay, EndoPredict, and the Breast Cancer Index are

considered unproven and/or not medically necessary for all other indications. Gene expression profiling assays for breast cancer treatment other than those previously described as covered are considered unproven and/or not medically necessary, including but not limited to: BluePrint (also referred to as "80-gene profile")



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REVISED



(continued)

Apr. 1, 2018

Breast Cancer Gene Expression Ratio (also known as Theros H/I) BreastNext BreastOncPX

BreastPRS Insight DX Breast Cancer Profile Mammostrat

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

TargetPrint TheraPrint The 41-gene signature assay The 76-gene "Rotterdam signature" assay To date, the majority of the available studies fail to provide sufficient

evidence that gene expression profiling is useful for managing the treatment of breast cancer and leads to improved health outcomes (i.e., clinical utility).

Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression profiling as a technique of managing the treatment of breast cancer compared with traditional clinical factors to guide medical management and improve clinical outcomes.

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

To identify the tissue of origin for cancers of unknown primary site, gene expression profiling assays are considered unproven and/or not medically necessary for all indications, including but not limited to:

ResponseDX: Tissue of Origin Test CancerTYPE ID Test Rosetta Cancer Origin Test (miRview mets and miRview mets2 tests)

ProOnc TumorSourceDX Test To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling to identify the tissue of origin for cancers lead to improved health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression profiling to identify the tissue of origin for



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REVISED



(continued)

Apr. 1, 2018

cancers of unknown primary site compared with traditional clinicopathologic factors to guide medical management and improve clinical outcomes. Gene Expression Profiling of Melanoma

In cutaneous and uveal melanoma, gene expression profiling assays

are considered unproven and/or not medically necessary for all indications, including but not limited to: DecisionDx-Melanoma test DecisionDx-UM To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling of melanoma leads to improved

health outcomes (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene expression profiling of melanoma compared with traditional clinical factors to guide medical management and improve clinical outcomes.

Gene Expression Profiling as a Technique for Colorectal Cancer (CRC) Risk Assessment or Management

In colorectal cancer (CRC) risk assessment or management, gene expression profiling assays are considered unproven and/or not

medically necessary, including but not limited to: Oncotype DX Colon Cancer Assay Colorectal Cancer DSA GeneFx Colon OncoDefender-CRC

To date, the majority of the available studies fail to provide sufficient evidence that gene expression profiling as a technique for colorectal cancer

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

improve clinical outcomes. Gene Expression Profile Tests for Evaluation or Management of Multiple Myeloma

Gene expression profile tests for evaluation or management of



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REVISED



(continued)

Apr. 1, 2018

multiple myeloma are considered unproven and/or not medically necessary, including but not limited to: MyPRS/MyPRS Plus

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

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

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

Gene-based tests for the screening, detection and management of prostate cancer are considered unproven and/or not medically

necessary, including but not limited to: Oncotype DX Prostate Cancer Assay

TMPRSS2 fusion gene Prolaris Prostate Cancer Test Decipher Prostate Cancer Classifier To date, the majority of the available studies fail to provide sufficient evidence that gene-based tests for the screening, detection and

management of prostate cancer lead to improved health outcomes or to manage treatment decisions (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of gene-based tests for the screening, detection and management of prostate cancer

compared with traditional clinical factors to guide medical management and improve clinical outcomes. Topographic Genotyping

Topographic genotyping is unproven and/or not medically necessary.

Examples of such tests include, but are not limited to, the following: PathFinder TG To date, the majority of the available studies fail to provide sufficient evidence that topographic genotyping lead to improved health outcomes



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REVISED



(continued)

Apr. 1, 2018 (i.e., clinical utility). Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of topographic genotyping compared with traditional clinical factors to guide medical management and improve

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

Molecular profiling of tumors using a multi-gene cancer panel of up to 50 genes is considered proven and/or medically necessary for individuals with metastatic non-small cell lung cancer (NSCLC). Use of more than one gene multi-gene cancer panel for the same

individual with non-small cell lung cancer is unproven and/or not medically necessary. Multi-gene cancer panels are considered unproven and/or not medically necessary for all other indications.

Multi-gene cancer panels of greater than 50 genes are considered

unproven and/or not medically necessary for all indications.

Observation Care

Apr. 1, 2018

Revised coverage rationale: o Replaced language indicating

“Oxford reserves the right to review observation care claims in order to substantiate that the

services were provided in accordance with this policy and MCG™ Care Guidelines”

with “Oxford reserves the right to review observation care in order to substantiate

that the services were provided in accordance with MCG™ Care Guidelines”

o Replaced reference to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™

Oxford reserves the right to review observation care in order to substantiate that the services were provided in accordance with MCG™ Care Guidelines. Review may occur on a prospective, concurrent and/or retrospective basis. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, General Criteria: Observation Care (OCG): OC-022 (ISC).

Note: For additional information regarding coding and documentation for

observation care services, refer to the reimbursement policy titled Observation Care Evaluation and Management Codes.

Observation time begins at the clock time, documented in the patient's

record, which coincides with the time that observation care is initiated in accordance with a physician's order. Observation time ends when all medically necessary services related to observation care are completed. For example, this could be before discharge when the need for observation has ended, but other medically necessary services not meeting the definition of observation care are provided.



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REVISED

Observation Care (continued)

Apr. 1, 2018 Care Guidelines, 22nd edition, 2018”

o Removed language

pertaining to the observation care review process

Obstructive Sleep Apnea Treatment

Apr. 1, 2018

Revised coverage rationale: o Replaced language


proven and medically

necessary” with “[the listed services] are proven and/or medically necessary”

“[The listed services] are unproven and not medically necessary”

with “[the listed services] are unproven and/or not medically necessary”

o Replaced references to “MCG™ Care Guidelines, 21st

edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”; refer to 22nd edition for complete details on applicable updates to the MCG™ Care Guidelines

Nonsurgical Treatment

Removable oral appliances are proven and/or medically necessary for treating obstructive sleep apnea (OSA) as documented by a sleep study (e.g., polysomnography or home sleep apnea testing). Refer to the policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition,

2018, Oral Appliances (Mandibular Advancement Devices), A-0341 (ACG). Removable oral appliances are unproven and/or not medically necessary for treating central sleep apnea. This type of sleep apnea is caused by impaired neurological function, and

these devices are designed to manage physical obstructions.

Nasal dilator devices are unproven and/or not medically necessary for treating obstructive sleep apnea (OSA). There is insufficient clinical evidence supporting the safety and efficacy of nasal dilators for treating OSA. Results from available studies indicate that therapeutic response is variable among the participants. Further research from larger, well-designed studies is needed to evaluate the effectiveness of the device compared with established treatments for OSA, to determine its

long-term effectiveness and to determine which patients would benefit from this therapy. Surgical Treatment

The following surgical procedures are proven and/or medically necessary for treating obstructive sleep apnea as documented by polysomnography. Refer to the policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. Also see the Definitions section of the

policy for information on the definitions and severity of OSA. Maxillomandibular Advancement Surgery (MMA): For information

regarding medical necessity review, when applicable, see MCG™ Care



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REVISED

Obstructive Sleep Apnea Treatment (continued)

Apr. 1, 2018

Guidelines, 22nd edition, 2018, Maxillomandibular Osteotomy and Advancement, A-0248 (ACG). Also see the policy titled Orthognathic (Jaw) Surgery.

Multilevel Procedures whether done in a Single Surgery or Phased Multiple Surgeries: There are a variety of procedure combinations, including mandibular osteotomy and genioglossal

advancement with hyoid myotomy (GAHM). For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Mandibular Osteotomy, A-0247 (ACG).

Uvulopalatopharyngoplasty (UPPP): For information regarding

medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Uvulopalatopharyngoplasty (UPPP), A-0245 (AC).

The following surgical procedures are unproven and/or not medically necessary for treating Obstructive Sleep Apnea: Implantable hypoglossal nerve stimulation

Laser-assisted uvulopalatoplasty (LAUP) Lingual suspension - also referred to as tongue stabilization, tongue

stitch or tongue fixation Palatal implants Radiofrequency ablation of the soft palate and/or tongue base Transoral robotic surgery (TORS)

There is insufficient evidence to conclude that laser-assisted uvulopalatoplasty (LAUP) results in improved Apnea-Hypopnea Index (AHI) or secondary outcomes. Some studies saw a worsening of symptoms as well as increased complications. Results of studies provide preliminary but inconsistent evidence that palatal

implants benefit patients with mild to moderate OSA. However, the

magnitude of the benefits has been small; the largest randomized controlled trial (RCT) found that average OSA worsened in spite of treatment; and the available studies involved ≤ 1 year of patient monitoring after treatment. Additional studies are needed to determine the role of palatal implants in the management of OSA.

There is insufficient evidence to support the safety, efficacy and long-term outcomes of lingual suspension in the treatment of OSA. The published peer-reviewed medical literature includes a few small, uncontrolled studies with



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REVISED

Obstructive Sleep Apnea Treatment (continued)

Apr. 1, 2018 short-term follow-up. Large, controlled studies, with long-term follow-up, comparing lingual suspension to established procedures are necessary.

There is insufficient evidence to support the safety, efficacy and long-term outcomes of transoral robotic surgery (TORS) in the treatment of OSA. Large, controlled studies, with long-term follow-up, comparing TORS to

established procedures are necessary. There is insufficient evidence to support the safety, efficacy and long-term outcomes of hypoglossal nerve stimulation in the treatment of OSA. The

optimal patient selection criteria for the use of hypoglossal nerve stimulation have not been defined. Randomized controlled trials or comparative effectiveness trials with long-term follow-up, comparing hypoglossal nerve stimulation to established procedures are necessary to evaluate the effectiveness of this technology.

There is insufficient evidence to support the efficacy and long-term outcomes of radiofrequency ablation of the tongue or soft palate in the treatment of

OSA. Optimal patient selection criteria have not been defined. Large controlled studies or comparative effectiveness trials with long-term follow-up comparing radiofrequency ablation to established procedures are necessary.

Follow-up polysomnography should be performed following surgery to evaluate response to treatment (Kushida et al., 2006; Ferguson et al., 2006). Refer to the policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information.

Office Based Program

Apr. 1, 2018

Removed language indicating participating providers located in

New Jersey are excluded from

the office based program guidelines and prior authorization requirements

Revised list of applicable CPT codes for elective procedures requiring prior authorization if not performed in the office

setting; removed 11606

Introduction

In an effort to minimize out-of-pocket costs for Oxford members and to

improve cost efficiencies for the overall health care system, we are implementing prior authorization guidelines that aim to encourage more cost-effective sites of service for certain outpatient surgical procedures, when

medically appropriate. These prior authorization requirements apply to participating providers that are providing services to members enrolled on Oxford commercial plans that require services to be medically necessary, including being cost-effective. Refer to the member specific benefit plan document to determine if medical



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REVISED

Office Based Program (continued)

Apr. 1, 2018 necessity applies. Coverage Rationale

With the exception of the qualifying conditions below, certain elective procedures should be performed in an Office setting.

The following will be taken into account to determine whether the elective procedure is being performed in a cost effective setting: Member’s benefit plan Geographic availability of an in network provider Office capability (i.e., appropriate equipment) Significant member comorbidities

Certain Qualifying Conditions

Some patients may require more complex care due to certain medical factors or functional limitations and it may be appropriate to have the procedure in an outpatient hospital setting or ambulatory surgery center. (Not an all-

inclusive list). Patient unable to cooperate with procedure due to mental status, severe

anxiety, or extreme pain sensitivity Failed office based procedure attempt due to body habitus, abnormal

anatomy, or technical difficulties Bleeding disorder that would cause a significant risk of morbidity Allergy to local anesthetic Potential Documentation Requirements

Physician office notes Elective Procedures List

Prior authorization is required for the following procedures if not performed in an office setting (see Applicable Codes section of the policy).

Omnibus Codes

Apr. 1, 2018

Revised coverage rationale: o Added language to indicate

balloon dilation (CPT code 69799) is unproven and not medically necessary for

treating eustachian tube

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



Oxford


REVISED

Omnibus Codes (continued)

Apr. 1, 2018

dysfunction (ETD) due to insufficient clinical evidence of safety and/or efficacy in

published peer-reviewed medical literature

o Revised coverage guidelines

for dermal/skin substitutes: Added language to

indicate:

- TransCyte is proven and medically necessary for treating surgically excised full-thickness thermal burn

wounds* and deep partial-thickness

thermal burn wounds** in persons who require such a covering before autograft placement

*A full-thickness burn (third degree burn) is a burn with destruction of all layers of the

skin;these burns

involve all of the epidermal and dermal layers, with varying amounts of the sub-cutaneous

layer involvement (Committee on



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REVISED


Apr. 1, 2018

Trauma American College of Surgeons,

1999) **A partial-

thickness burn

(second degree burn) involves the epidermis and only part of

the dermis; deep partial thickness burns involve the epidermis and most parts of the dermis, leaving

few intact skin appendages and

nerve endings (Committee on Trauma American College of Surgeons,

1999) - TransCyte is

unproven and not medically necessary for all other indications due to

insufficient clinical

evidence of safety and/or efficacy in published peer-reviewed medical literature

Updated list of

unproven/not medically necessary dermal/skin substitutes:



Oxford


REVISED


Apr. 1, 2018 - Added: Amnio Wound™ BioSkin™

BioSkin™ Flow Clarix® Floweramnioflo™

or FlowerFlo™ Floweramniopatc

h™ or FlowerPatch™

FlowerDerm™ GrafixPL® Kerecis™ NeoPatch™ Revita™ WoundEx™

WoundEx™ Flow - Removed:

AmnioPro™, BioRenew™, BioSkin™, or WoundEx™

AmnioPro™ Flow,

BioRenew™ Flow, BioSkin™ Flow, or WoundEx™ Flow

Updated list of applicable HCPCS codes to reflect

annual code edits; added

Q4176, Q4177, Q4178, Q4179, Q4180, Q4181, and Q4182

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

Orthognathic (Jaw)

Surgery

Apr. 1, 2018

Revised coverage rationale:

o Replaced reference(s) to: “Patient-specific clinical


Orthognathic (jaw) surgery is a standard exclusion from coverage in most



Oxford


REVISED

Orthognathic (Jaw) Surgery (continued)

Apr. 1, 2018

review” with “member-specific clinical review”

“Patient” with

“individual” “MCG™ Care Guidelines,

21st edition, 2017” with

“MCG™ Care Guidelines, 22nd edition, 2018”

o Replaced language indicating “orthognathic surgery is a

reconstructive procedure and is considered to be medically necessary when both the skeletal deformity and the functional impairment criteria [in the policy] are

met” with “orthognathic (jaw) surgery is a

reconstructive procedure and medically necessary and is considered covered when both the skeletal deformity and the functional

impairment criteria [in the policy] are met”

o Updated language pertaining to anteroposterior discrepancies to indicate the established norm equals

2mm

Updated definitions: o Added definition of “Sequela” o Modified definition of:

Cancer Sequela Post-Surgical Sequela

fully-insured plans. The following list represents the covered exceptions to the oral surgery exclusion.

The following are eligible for coverage as reconstructive and medically necessary: Acute traumatic injury, and Post-Surgical Sequela (please see Post-

Surgical Sequela in the Definitions section of the policy) Cancerous or non-cancerous tumors and cysts, Cancer and Post-Surgical

Sequela (please see Cancer Sequela and Post-Surgical Sequela in the Definitions section of the policy).

The following are eligible for coverage when the criteria are met (see Criteria section below): Obstructive sleep apnea (refer to the policy titled Obstructive Sleep

Apnea Treatment for additional information) Cleft lip/palate (for cleft lip/palate related Jaw Surgery)

Congenital anomalies that meet the criteria for reconstructive. Depending on a member-specific clinical review, examples include: Pierre Robin

Syndrome, Hemifacial Microsomia and Treacher Collins Syndrome. Criteria

All orthognathic (jaw) surgeries are subject to some level of review. For the above covered exceptions that require review, the following criteria should be applied.

Orthognathic (jaw) surgery is a reconstructive procedure and medically necessary and is considered covered when both the skeletal deformity AND the Functional Impairment criteria below are met:

The presence of any of the following facial skeletal deformities associated with masticatory malocclusion: o Anteroposterior Discrepancies (established norm=2mm)

Maxillary/Mandibular incisor relationship: overjet of 5mm or more, or a 0 to a negative value

Maxillary/Mandibular anteroposterior molar relationship discrepancy of 4mm or more

These values represent two or more standard deviation from published norms

o Vertical Discrepancies



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REVISED


Apr. 1, 2018

Presence of a vertical facial skeletal deformity which is two or more standard deviations from published norms for accepted skeletal landmarks.

Open bite: - No vertical overlap of anterior teeth - Unilateral or bilateral posterior open bite greater than 2mm

Deep overbite with impingement or irritation of buccal or lingual soft tissues of the opposing arch

Supraeruption of a dentoalveolar segment due to lack of occlusion

o Transverse Discrepancies Presence of a transverse skeletal discrepancy which is two or

more standard deviations from published norms Total bilateral maxillary palatal cusp to mandibular fossa

discrepancy of 4mm or greater, or a unilateral discrepancy of 3mm or greater, given normal axial inclination of the posterior

teeth o Asymmetries

Anteroposterior, transverse or lateral asymmetries greater than 3mm with concomitant occlusal asymmetry

In addition to meeting the skeletal deformity requirement above, the individual must also have one or more of the following Functional Impairments:

o Masticatory (chewing) and swallowing dysfunction due to skeletal malocclusion (e.g., inability to incise and/or chew solid foods, choking on incompletely masticated solid foods, damage to soft tissue during mastication, malnutrition)

o Documentation of speech deficits to support existence of speech impairment skeletal malocclusion

o Moderate to severe obstructive sleep apnea as measured by

polysomnography (AASM Obstructive Sleep Apnea; and Practice Parameters for the Surgical Modifications of the Upper Airway for Obstructive Sleep Apnea in Adults), defined as: Moderate for AHI or RDI ≥ 15 and ≤ 30 Severe for AHI or RDI > 30/hr and

o Oropharyngeal narrowing secondary to maxillomandibular deficiency is the primary cause of moderate to severe obstructive sleep apnea. [See MCG™ Care Guidelines, 22nd edition, 2018, Maxillomandibular



Oxford


REVISED


Apr. 1, 2018 Osteotomy and Advancement A-0248 (ACG).] For Obstructive Sleep Apnea

In addition to the criteria above, also refer to the following: Maxillomandibular advancement surgery (MMA): For information

regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Maxillomandibular Osteotomy and Advancement, A-0248 (ACG).

Multilevel procedures whether done in a single surgery or phased multiple surgeries: There are a variety of procedure combinations, including mandibular osteotomy and genioglossal advancement with hyoid myotomy (GAHM). For information regarding medical necessity

review, when applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Mandibular Osteotomy, A-0247 (ACG).

Coverage Limitations and Exclusions

Except where state mandated, the following are not covered:

Cosmetic and non-reconstructive Jaw Surgery and jaw alignment procedures (Orthognathic Surgery) that do not meet the criteria in the Indications for Coverage section above are excluded from coverage.

Surgery for torus mandibularis and torus palatinus for fabrication of

dentures is not covered. Pre and post-surgical orthodontic treatment. Additional Information

Some states may require orthognathic (jaw) surgery for cleft lip and cleft palate, or for services that Oxford 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.

Orthopedic

Services

Apr. 1, 2018

Revised coverage rationale and

supporting information; replaced references to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”

Oxford covers medically necessary acute care services and post-acute

services delivered at the most appropriate level of care. OrthoNet's orthopedic division will perform utilization management to review requested services that should meet approved clinical guidelines for medical necessity. Review is conducted by determining medical necessity and medical appropriateness, and to initiate discharge planning as appropriate. The review will be based on the obtained clinical information and some or all of the following criteria/tools:

MCG™ Care Guidelines, 22nd edition, 2018 (Inpatient Care)



Oxford


REVISED

Orthopedic Services (continued)

Apr. 1, 2018

Member benefits Oxford medical and reimbursement policies Services performed by the following specialists (participating/non-

participating), regardless of diagnosis, are subject to utilization review with OrthoNet’s orthopedic division. Hand surgeon

Neurosurgeon Orthopedic surgeon Pediatric orthopedic surgeon Physical medicine and rehabilitation

Podiatrist

and

Services rendered by the below facilities (participating/non-participating), when billed in conjunction with certain identified ICD-10 diagnosis codes (see

the Applicable Codes section of the policy for a list of diagnosis codes) are subject to utilization review with OrthoNet’s orthopedic division. Acute care hospital

Ambulatory surgery center Durable medical equipment Home health care Other ancillary

Physical rehabilitation facility Physical rehabilitation hospital Skilled nursing facility Medical Director Review Requirements

If a request is submitted which: Meets the applicable guideline(s)/medical criteria, an OrthoNet

Case Manager may make a utilization review decision (with oversight by

a Medical Director).

Does not meet the applicable guideline(s)/criteria, and/or there is a question regarding whether the request is a covered benefit, the request will be referred to an OrthoNet Medical Director for review and decision-making.

Additional information as well as input from a consultant may be requested

and reviewed as part of this process. In the case of non-certification decisions, where the OrthoNet Case Manager



Oxford


REVISED

Orthopedic Services (continued)

Apr. 1, 2018 did not make an attempt to discuss the matter with the member’s provider, a reconsideration procedure will be offered and activated according to current regulatory requirements and Oxford policy.

A Medical Director must make all adverse utilization review decisions including those for benefit non-certifications (with the exception of non-

certification due to the member's enrollment status with Oxford and approval determinations). Note:

Pre-Existing Conditions: Individuals of any age cannot be denied coverage, charged higher premiums, subjected to an extended waiting period or have benefits modified because of a preexisting condition.

Payment for requested services will be based on Oxford’s medical and reimbursement policies.

Outpatient Cardiac Telemetry

Apr. 1, 2018

Changed policy title; previously titled Outpatient Cardiovascular

Telemetry Revised coverage rationale:

o Replaced references to “outpatient cardiovascular telemetry” with “outpatient cardiac telemetry”

o Replaced language indicating: “Outpatient

cardiovascular telemetry is proven and medically necessary for the [listed]

indications” with

“outpatient cardiac telemetry is proven and/or medically necessary for the [listed] indications”

“Event monitors may be used for a short duration

(e.g., 24-48 hours)” with “event monitors may be

Outpatient cardiac telemetry is proven and/or medically necessary for the following indications:

Suspected cardiac arrhythmia not detected with standard cardiac event monitoring*

Cryptogenic stroke with suspected occult atrial fibrillation as the cause of the stroke

Monitoring arrhythmia status following an ablation procedure

*Standard cardiac event monitoring includes non-implantable cardiac event monitors that record cardiac events for days, weeks or months. Event recording may be patient activated or automatically collected. The patient then periodically telephones events to a central collection area. Standard cardiac event monitoring must be of sufficient duration to detect a cardiac arrhythmia under consideration. Event monitors may be used for a short

duration (e.g., 3-14 days) or for a longer period (e.g., 14-30 days or longer).

A physician who suspects an occult arrhythmia will order event monitoring for a longer time period; therefore, non-diagnostic 24-48 hour Holter monitoring to detect a cardiac arrhythmia would not be an indication for outpatient cardiac telemetry.



Oxford


REVISED

Outpatient Cardiac Telemetry (continued)

Apr. 1, 2018 used for a short duration (e.g., 3-14 days)”


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

Pneumatic Compression Devices

Apr. 1, 2018 Revised coverage rationale: o Added language to indicate

pneumatic compression devices are proven and/or

medically necessary in certain circumstances

o Replaced language indicating “for information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition,

2017” with “for applicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018”

o Added instruction to refer to the Applicable Codes section

of the policy for more information regarding the review of HCPCS code E0652 (pneumatic compressor, segmental home model with calibrated gradient pressure)

Pneumatic compression devices are proven and/or medically necessary in certain circumstances. For rapplicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018, Intermittent Pneumatic Compression with Extremity Pump ACG: A-0340 (AC).

Refer to the Applicable Codes section of the policy for more information regarding the review of HCPCS code E0652 (pneumatic compressor, segmental home model with calibrated gradient pressure).

Preventive Care Services

Apr. 1, 2018 Revised list of applicable procedure codes for Preventive

Immunizations: o Updated list of applicable

CPT codes for Zoster/Shingles (HZV/ZVL, RZV); added 90750 (Shingrix®) with benefit age

limit of 50 years and older

Refer to the policy for complete details on the coverage guidelines for Preventive Care Services.



Oxford


REVISED

Respiratory Interleukins (Cinqair®,

Fasenra®, and Nucala®)

Apr. 1, 2018

Revised coverage rationale: o Replaced language indicating

“this policy provides

information about the use of certain specialty pharmacy medications administered by

either the subcutaneous (SC) or intravenous (IV) route for severe asthmatic conditions” with “this policy

provides information about the use of certain specialty pharmacy medications administered by either the subcutaneous (SC) or intravenous (IV) route”

o Added coverage guidelines for eosinophilic

granulomatosis with polyangiitis (EGPA) to indicate:

Initial Therapy

Nucala for subcutaneous use is proven for the treatment of EGPA

Nucala is medically

necessary for the treatment of EGPA when all of the following

criteria are met: - Diagnosis of

relapsing or refractory EGPA as

defined by all of the following: Diagnosis with

EPGA, and Past medical

history or

Refer to the policy for complete details on the coverage guidelines for Respiratory Interleukins (Cinqair®, Fasenra®, and Nucala®).



Oxford


REVISED


Fasenra®, and Nucala®) (continued)

Apr. 1, 2018

presence of asthma, and

One of the

following values at diagnosis: o Blood

eosinophil level of at least 10% of leucocytes

o Absolute eosinophil count > 1,000 cells/µL

Presence of at

least two of the following

characteristics typical of EGPA: o Histopatholo

gical evidence of:

Eosinophilic vasculitis

Perivascular eosinophilic infiltration

Eosinophil-

rich

granuloma-tous inflammation

o Neuropathy, mono or poly (motor

deficit or nerve conduction



Oxford


REVISED



Apr. 1, 2018

abnormality) o Pulmonary

infiltrates,

non-fixed o Sino-nasal

abnormality

o Cardiomyopathy (established by

echocardio-graphy or MRI)

o Glomerulonephritis (hematuria,

red cell casts,

proteinuria) o Alveolar

hemorrhage (by bronchoal-

veolar lavage)

o Palpable purpura

o Anti-neutrophil

cytoplasmic

antibody (ANCA) positive

and History of

relapsing or

refractory disease defined as one of the



Oxford


REVISED



Apr. 1, 2018

following: o Relapsing

disease as

defined as a past history (within the

past 2 years) of at least one EGPA relapse

(requiring additional or dose escalation of cortico-steroids or

immunosuppressant, or

hospitalizat-ion)

o Refractory disease as defined as

failure to attain remission within the prior 6 months

following

induction treatment with standard therapy regimens

and - Patient is currently

taking standard



Oxford


REVISED



Apr. 1, 2018

therapy (corticosteroids with or without

immunosuppressive therapy); and

- Patient is not

receiving Nucala in combination with either of the following:

Cinqair (reslizumab)

Fasenra (benralizumab)

Xolair (omalizumab)

and - Nucala dosing for

EGPA is in accordance with the U. S. Food and Drug Administration approved labeling:

300mg subcutaneously once every 4 weeks; and

- Prescribed by or in consultation with a pulmonologist,

rheumatologist, or

allergist/immun-ologist; and

- Initial authorization will be for no more than 6 months

Reauthorization/Continua

tion of Care Criteria Authorization for

continued use of Nucala



Oxford


REVISED



Apr. 1, 2018

for the treatment of EGPA will be approved based on all of the

following criteria: - Documentation of

positive clinical

response as demonstrated by at least one of the following:

Reduction in the frequency and/or severity of relapses

Reduction or discontinuation

of doses of corticosteroids

and/or immuno-suppressant

Disease remission

Reduction in

severity or frequency of EGPA-related symptoms

and - Patient is not

receiving Nucala in

combination with either of the following: Cinqair

(reslizumab) Fasenra

(benralizumab) Xolair

(omalizumab)



Oxford


REVISED



Apr. 1, 2018 and - Nucala dosing for

EGPA is in

accordance with the U. S. Food and Drug Administration

approved labeling: 300mg subcutaneously once every 4 weeks; and

- Prescribed by or in consultation with a pulmonologist, rheumatologist, or allergist/immunol-ogist; and

- Reauthorization will be for no more than

12 months o Updated list of unproven and

not medically necessary indications; added: Granulomatosis with

polyangiitis (Wegener’s) Microscopic polyangiitis Organ or life-threatening

EGPA Updated list of applicable ICD-10

diagnosis codes; added M30.1


to reflect the most current background information, clinical evidence, FDA information, and references



Oxford


REVISED

Shoulder Replacement Surgery

(Arthroplasty)


shoulder replacement

surgery is proven and/or medically necessary in certain circumstances

o Replaced language indicating “for information regarding medical necessity review, when applicable, see MCG™

Care Guidelines, 21st edition, 2017” with “for applicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018”; refer to 22nd edition for complete details

on applicable updates to the MCG™ Care Guidelines

Updated list of applicable CPT codes; removed 23616

Updated supporting information to reflect the most current FDA information

Shoulder replacement surgery is proven and/or medically necessary in certain circumstances. For applicable clinical coverage criteria, see the following MCG™ Care Guidelines, 22nd edition, 2018:

Shoulder Arthroplasty, S-634 (ISC). Shoulder Hemiarthroplasty, S-633 (ISC).

Site of Service Guidelines for Certain Outpatient Surgical Procedures

Apr. 1, 2018

Revised benefit considerations; removed language indicating this policy does not apply to participating providers located in New Jersey (NJ)

With the exception of the qualifying conditions below, certain elective procedures should be performed in an Ambulatory Surgical Center (ASC). The following will be taken into account to determine whether the elective procedure is being performed in a cost effective setting:

Member’s benefit plan

Geographic availability of an in network provider Ambulatory Surgical Care (ASC) capability Physician privileging Significant member comorbidities (see list of examples of Qualifying

Conditions below) American Society of Anesthesiologist (ASA) physical status (PS),

classification system



Oxford


REVISED

Site of Service Guidelines for Certain Outpatient

Surgical Procedures (continued)

Apr. 1, 2018

Potential Documentation Requirements

Physician office notes Physician privileging ASA score

Certain Qualifying Conditions

Some patients may require more complex care due to factors such as age or

medical conditions. Also, some ASCs may have specific guidelines that prohibit members who are above a certain weight or have certain health conditions from receiving care in those facilities. Patients with severe systemic disease and some functional limitation (ASA PS classification III or higher) may be appropriate to have the procedure in an outpatient hospital setting (not an all-inclusive list):

Morbid obesity (>BMI.40) Diabetes (Brittle Diabetes) Resistant hypertension (Poorly Controlled)

Chronic Obstructive Pulmonary Disease (COPD) (FEV1 < 50%) Advance liver disease (MELD Score > 8) Alcohol dependence (at risk for withdrawal syndrome) End stage renal disease [Hyperkalemia (above reference range

peritoneal or hemodialysis)] Uncompensated Chronic Heart Failure (CHF) (NYHA class III or IV) History of Myocardial Infarction (MI) [recent event (< 3 mo.)] History of Cerebrovascular Accident (CVA) or Transient Ischemic Attack

(TIA) [recent event (< 3 mo.)] Coronary Artery Disease (CAD)/Peripheral Vascular Disease (PVD)

[ongoing cardiac ischemia requiring medical management recently placed drug eluting stent (within 1 year)]

Sleep apnea [moderate to severe Obstructive Sleep Apnea (OSA)] Implanted pacemaker Personal history or family history of complication of anesthesia such as

malignant hyperthermia Pregnancy

Bleeding disorder requiring replacement factor or blood products or special infusion products to correct a coagulation defect (DDAVP is not blood product and is OK)

Prolonged surgery (>3 hrs.) Anticipated need for transfusion



Oxford


REVISED

Site of Service Guidelines for Certain Outpatient

Surgical Procedures (continued)

Apr. 1, 2018 Recent history of drug abuse (especially cocaine) Patients with Drug Eluting Stents (DES) placed within one year or bare

metal stents (BMS) or plain angioplasty within 90 days unless

Acetylsalicylic Acid (ASA) and antiplatelet drugs will be continued by agreement of surgeon, cardiologist and anesthesia

Ongoing evidence of myocardial ischemia

Poorly controlled asthma (FEV1 < 80% despite medical management) Significant valvular heart disease Cardiac arrhythmia (symptomatic arrhythmia despite medication) Elective Procedures List

Prior authorization is required for the following procedures if performed in an

outpatient hospital setting (see Applicable Codes table in this policy).

Sodium Hyaluronate

Apr. 1, 2018

Revised coverage rationale: o Updated list of U.S. Food and

Drug Administration (FDA) labeled indications for

administration of intra-articular injections of sodium

hyaluronate: Added:

- Durolane (1 injection)

- Visco-3 (3 injections) Replaced “Gel-Syn (3

injections)” with

“Gelsyn-3 (3 injections)” o Replaced references to “Gel-

Syn” with “Gelsyn-3”

o Replaced language indicating: “[The listed services] are


“[The listed services] are

Initial Course of Administration/Treatment

Intra-articular injections of sodium hyaluronate are proven and/or

medically necessary for treating pain due to osteoarthritis (OA) of

the knee when administered according to U.S. Food and Drug Administration (FDA) labeled indications.

FDA Labeling*

Durolane 1 injection

Euflexxa 3 injections

Gel One 1 injection

Gelsyn-3 3 injections

GenVisc 850 3 to 5 injections

Hyalgan 5 injections

Hymovis 2 injections

Monovisc 1 injection

Orthovisc 3 to 4 injections

Supartz 3 to 5 injections

Synvisc 3 injections

Synvisc One 1 injection

Visco-3 3 injections



Oxford


REVISED

Sodium Hyaluronate (continued)

Apr. 1, 2018

unproven and not medically necessary” with “[the listed

services] are unproven and/or not medically necessary”

“Repeated courses of intra-articular sodium hyaluronan injections of the knee may be

considered proven and medically necessary under the [listed] conditions” with “repeated courses of intra-articular

hyaluronan injections may be considered under

the [listed] conditions” o Added language to indicate:

Pre-certification is required in all settings for Durolane (CPT code

J7321) and Visco-3 (CPT code J3490)

Durolane (hyaluronic acid) and Visco-3 (sodium hyaluronate) are proven and/or

medically necessary for

members with osteoarthritis of the knee who have met the criteria [listed in the policy] and the member has a history of failure,

contraindication or intolerance documented trial and failure to

*Hyaluronic acid preparations for the treatment of pain due to OA of the knee are deemed therapeutically equivalent. The UnitedHealth Group National Pharmacy and Therapeutics Committee has defined therapeutically

equivalent, products that can be expected to produce essentially the same therapeutic outcome and toxicity.

Note: There is no evidence that use of one intra-articular hyaluronan product is superior to another. Repeated courses of intra-articular hyaluronan injections may be

considered under the following conditions: Documentation of significant pain relief achieved with the prior course of

injections; and Pain has recurred; and At least six (6) months have passed since the prior course of treatment.

Intra-articular injections of sodium hyaluronate are proven and/or

medically necessary for treating temporomandibular joint (TMJ) disc displacement and OA.

Euflexxa, and Synvisc or Synvisc-One (J7323, J7325)

Pre-certification is not required in the office for J7323 and J7325.

Intra-articular hyaluronan injections, Euflexxa (1% sodium hyaluronate), and Synvisc (Hylan G-F 20) or Synvisc-One (Hylan G-F 20), are proven and/or medically necessary for members with osteoarthritis of the knee who meet all of the following criteria: The member has documented symptomatic osteoarthritis of the knee; The member reports pain which interferes with functional activities (e.g.,

ambulation, prolonged standing);

The member has not responded adequately to conservative therapy which may include physical therapy or pharmacotherapy (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen and/or topical capsaicin cream) or injection of intra-articular steroids and such therapy has not resulted in functional improvement after at least 3 months, or the member is unable to tolerate conservative therapy

because of adverse side effects; The pain cannot be attributed to other forms of joint disease; and There are no contraindications to the injections (e.g., active joint



Oxford


REVISED


Apr. 1, 2018

Synvisc, Synvisc-One or Euflexxa


to reflect the most current clinical evidence and FDA information

infection, bleeding disorder). Hyalgan, Supartz, and Visco-3 (J7321), Orthovisc (J7324), Gel-One

(J7326), Monovisc (J7327), Gelsyn-3 (J7328), GenVisc 850 (J7320), Hymovis (J7322), and Durolane (3490)

Pre-certification is required in all settings for J7320, J7321, J7322, J7324, J7326, J7327, J7328 and J3490. Intra-articular hyaluronan injections, Hyalgan (sodium hyaluronate) and Supartz (sodium hyaluronate), Visco-3 (sodium hyaluronate), Orthovisc (high molecular weight form of hyaluronic acid), Gel-One (hyaluronan), Monovisc (cross-linked sodium hyaluronate), Gelsyn-3

(sodium hyaluronate), GenVisc 850 (sodium hyaluronate), Hymovis (hyaluronic acid), and Durolane (hyaluronic acid) are proven and/or medically necessary for members with osteoarthritis of the knee who have met the criteria above and: The member has a history of failure, contraindication or intolerance

documented trial and failure to Synvisc, Synvisc-One or Euflexxa.

Sodium hyaluronate preparations are unproven and/or not medically necessary for treating any other indication not listed above as medically necessary including but not limited to: Pain due to OA in any joint other than the knee or TMJ Any other form of arthritis [including rheumatoid arthritis (RA)] Patello-femoral syndrome

Chondromalacia of the knee Following total or partial knee joint replacement Increase in viscoelasticity of synovial fluid after sodium hyaluronate injection

has not been demonstrated in patients with RA, and it has not been determined whether sodium hyaluronate is protective in joints affected by RA. Further studies are needed to determine the safety and durability of such

treatment for patello-femoral syndrome and chondromalacia of the knee and whether it significantly delays the need for more invasive treatment, e.g., surgery, joint replacement or arthroplasty. There are no clinical studies evaluating the use of sodium hyaluronate in persons following total or partial knee joint replacement surgery. Hyaluronic acid gel preparations to improve the skin's contour



Oxford


REVISED


Apr. 1, 2018 and/or reduce depressions due to acne, scars, injury or wrinkles are considered cosmetic. The use of sodium hyaluronate preparations to improve the skin's contour

and/or reduce depressions in the skin due to acne, scars, injury or wrinkles improves physical appearance but does not remove or improve a functional impairment of the skin.

Specialty Medication Administration - Site of Care Review

Guidelines

Apr. 1, 2018

Revised coverage rationale and supporting information; replaced references to “MCG™ Care Guidelines, 21st edition, 2017”

with “MCG™ Care Guidelines, 22nd edition, 2018”

This policy addresses the criteria for consideration of allowing hospital outpatient facility specialty medication infusion services. This includes claim submission for hospital based services with the following CMS/AMA Place of Service codes:

22 On-Campus - Outpatient Hospital; and 19 Off-Campus - Outpatient Hospital Alternative sites of care, such as non-hospital outpatient infusion, physician office, ambulatory infusion or home infusion services are well accepted places of service for medication infusion therapy. If a patient does not meet criteria for outpatient hospital facility infusion, alternative sites of care may

be used. Outpatient hospital facility-based intravenous medication infusion is medically necessary for members who meet any of the following criteria (submission of medical records detailing at least one of the following criteria is required):

Medically unstable based upon submitted clinical history; or Initial medication infusion of or re-initiation after more than 6 months

following discontinuation of therapy; or Previous experience of a severe adverse event following infusion.

Examples include but are not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure; or

Continuing experience of adverse events that cannot be mitigated by

pre-medications or infusion rate adjustments; or Physically and/or cognitively impaired and no home caregiver available;

or Difficulty establishing and maintaining patent vascular access; or Homecare or infusion provider has deemed that the patient, home

caregiver, or home environment is not suitable for home infusion therapy.

This policy applies to these specialty medications that require healthcare



Oxford


REVISED

Specialty Medication Administration -

Site of Care Review Guidelines (continued)

Apr. 1, 2018 provider administration: Actemra® (tocilizumab) Entyvio® (vedolizumab)

Exondys 51™ (eteplirsen) Ilaris® (canakinumab) Inflectra™ (infliximab-dyyb)

Ocrevus™ (ocrelizumab) Orencia® (abatacept) Radicava™ (edaravone) Remicade® (infliximab)

Renflexis™ (infliximab-abda) Simponi® Aria™ (golimumab) Soliris® (eculizumab) Medical necessity criteria for administration of intravenous infusion therapy at home are addressed in MCG™ Care Guidelines, 22nd edition, 2018, Home

Infusion Therapy, CMT: CMT-0009(SR).

Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins

Apr. 1, 2018

Replaced references to “patient” with “individual”

Revised coverage rationale: o Replaced reference to:

“Greater Saphenous” with “Greater Saphenous

Veins” “Small saphenous” with

“Small Saphenous Veins” o Replaced language

indicating: “Radiofrequency

ablation, endovenous

laser ablation, Stripping, Ligation and excision of the Great Saphenous Vein and Small Saphenous Veins are considered reconstructive and

medically necessary when all of the [listed]

Varicose Vein Ablative and Stripping Procedures

Radiofrequency ablation, endovenous laser ablation, Stripping,

Ligation and excision of the Great Saphenous Vein and Small Saphenous Veins are considered reconstructive, proven and/or medically necessary when ALL of the following criteria are present: Junctional Reflux (see Definitions section of the policy):

o Ablative therapy for the Great Saphenous Veins or Small Saphenous Veins will be considered reconstructive and therefore proven and medically necessary only if Junctional Reflux is demonstrated in

these veins; or o Ablative therapy for Accessory Veins will be considered

reconstructive and proven and medically necessary only if

anatomically related persistent Junctional Reflux is demonstrated after the Great Saphenous Veins or Small Saphenous Veins have been removed or ablated.

Member must have one of the following Functional Impairments: o Skin ulceration; or o Documented episode(s) of frank bleeding of the Varicose Vein due to

erosion of /or trauma to the skin; or o Documented Superficial Thrombophlebitis or documented Venous

Stasis Dermatitis; or



Oxford


REVISED

Surgical and Ablative Procedures for Venous

Insufficiency and Varicose Veins (continued)

Apr. 1, 2018

criteria are present” with “radiofrequency ablation, endovenous laser

ablation, Stripping, Ligation and excision of the Great Saphenous

Vein and Small Saphenous Veins are considered reconstructive, proven

and/or medically necessary when all of the [listed] criteria are present”

“Ablation of perforator veins is considered

reconstructive and medically necessary

when the [listed] criteria are present” with “ablation of perforator veins is considered reconstructive, proven

and/or medically necessary when the [listed] criteria are present”

“Ligation at the saphenofemoral junction,

as a stand-alone

procedure, is proven and medically necessary, when used to prevent the propagation of an active clot to the deep venous system in

individuals with ascending Superficial Thrombophlebitis who

o Moderate to severe pain causing Functional/Physical Impairment. Venous size:

o The Great Saphenous Vein must be 5.5mm or greater when

measured at the proximal thigh immediately below the sapheno-femoral junction via Duplex Ultrasonography.

o The Small Saphenous Vein or Accessory Veins must measure 5 mm

or greater in diameter immediately below the appropriate junction. Duration of reflux, in the standing or reverse Trendelenburg position that

meets the following parameters: o Greater than or equal to 500 milliseconds (ms) for the Great

Saphenous Vein, Small Saphenous Veins or principle tributaries. o Perforating veins > 350 ms. o Some Duplex Ultrasound readings will describe this as moderate to

severe reflux which will be acceptable. Ablation of perforator veins is considered reconstructive, proven

and/or medically necessary when the following criteria are present: Evidence of perforator Venous Insufficiency measured by recent Duplex

Ultrasonography report (see criteria above); and Perforator vein size is 3.5mm or greater; and Perforating vein lies beneath a healed or active venous stasis ulcer. Endovenous Mechanochemical Ablation (MOCA) of Varicose Veins

using a percutaneous infusion catheter is unproven and/or not medically necessary for treating Venous Reflux. There is insufficient evidence in the clinical literature supporting the safety and efficacy of MOCA for treating Varicose Veins. Further results from large, well-designed studies are needed to support the clinical utility of this approach.

Ligation Procedures

Ligation of the Great Saphenous Vein at the saphenofemoral

junction, as a stand-alone procedure, is unproven and/or not medically necessary for treating Venous Reflux. Ligation performed without Stripping or ablation is associated with high long-term recurrence rates due to neovascularization. Ligation of the Small Saphenous Vein at the saphenopopliteal junction, as a stand-alone procedure, is unproven and/or not



Oxford


REVISED



Apr. 1, 2018

fail or are intolerant of anticoagulation therapy” with “ligation at the

saphenofemoral junction, as a stand-alone procedure, is proven

and/or medically necessary, when used to prevent the propagation of an active clot to the

deep venous system in individuals with ascending Superficial Thrombophlebitis who fail or are intolerant of anticoagulation therapy”

“Endovenous foam sclerotherapy of

incompetent Great Saphenous Veins and accessory saphenous veins is unproven and not medically necessary

for treating Venous Reflux” with “endovenous foam sclerotherapy of incompetent Great Saphenous Veins, lesser

saphenous veins, and

accessory saphenous veins is unproven and/or not medically necessary for treating Venous Reflux”

o Replaced language indicating

“[the services listed below] are unproven and not medically necessary” with

medically necessary for treating Venous Reflux. Ligation performed without Stripping or ablation is associated with high long-term recurrence rates due to neovascularization.

Ligation at the saphenofemoral junction, as a stand-alone procedure, is proven and/or medically necessary, when used to prevent the

propagation of an active clot to the deep venous system in individuals with ascending Superficial Thrombophlebitis who fail or are intolerant of anticoagulation therapy.

Ligation at the saphenofemoral junction, as an adjunct to radiofrequency ablation or Endovenous Laser Ablation of the main saphenous veins, is unproven and/or not medically necessary for treating Venous Reflux. Published clinical evidence has not demonstrated that the addition of saphenofemoral Ligation to Endovenous Ablation procedures provides an

additive benefit in resolving Venous Reflux or preventing Varicose Vein recurrence. Endovenous Ablation is a clinically effective therapy for treating

Venous Reflux. Adding Ligation to the procedure adds clinical risk without adding clinical benefit. Endovascular embolization of Varicose Veins using cyanoacrylate-based adhesive is unproven and/or not medically necessary for

treating Venous Reflux. There is insufficient evidence in the published clinical literature supporting the safety and efficacy of endovascular embolization using cyanoacrylate-based adhesive for treating Varicose Veins. Further long-term results from large, well-designed studies are needed to support the clinical utility of this approach.

Endovenous foam sclerotherapy of incompetent Great Saphenous Veins, lesser saphenous veins and accessory saphenous veins is unproven and/or not medically necessary for treating Venous Reflux. There is insufficient evidence in the published clinical literature supporting the safety and efficacy of endovascular embolization using endovenous foam sclerotherapy for treating Varicose Veins. Further long-term results from

large, well-designed studies are needed to support the clinical utility of this approach.



Oxford


REVISED



Apr. 1, 2018

“[the services listed below] are unproven and/or not medically necessary”:

Endovenous mechanochemical ablation (MOCA) of

Varicose Veins using a percutaneous infusion catheter for treating Venous Reflux

Ligation of the Great Saphenous Vein at the saphenofemoral junction, as a stand-alone procedure for treating Venous Reflux

Ligation of the Small Saphenous Vein at the

saphenopopliteal junction, as a stand-alone procedure for treating Venous Reflux

Ligation at the

saphenofemoral junction, as an adjunct to radiofrequency ablation or endovenous laser ablation of the main saphenous veins for

treating Venous Reflux

Endovascular embolization of Varicose Veins using cyanoacrylate-based adhesive for treating Venous Reflux

Updated definition of: o Cosmetic Procedures o High Quality Photograph



Oxford


REVISED



Apr. 1, 2018 o Reconstructive Procedures o Sickness



Surgical Treatment for Spine Pain

Apr. 1, 2018


the listed spinal procedures are proven and/or medically

necessary in certain circumstances

o Replaced language indicating: “Spinal fusion using

extreme lateral interbody fusion (XLIF®)

or direct lateral interbody fusion (DLIF) is proven and medically necessary” with “spinal fusion using extreme lateral interbody fusion

(XLIF®) or direct lateral interbody fusion (DLIF) is proven and/or medically necessary”

“The [listed] spinal procedures are unproven

and not medically

necessary” with “the [listed] spinal procedures are unproven and/or not medically necessary”

“For information regarding medical necessity review, when

applicable, see MCG™ Care Guidelines, 21st

Spinal fusion using extreme lateral interbody fusion (XLIF) or direct lateral interbody fusion (DLIF) is proven and/or medically necessary. The following spinal procedures are proven and/or medically

necessary under certain circumstances. For applicable clinical coverage criteria, see the following MCG™ Care Guidelines, 22nd edition, 2018: Cervical Diskectomy or Microdiskectomy, Foraminotomy, Laminotomy, S-

310 (ISC) Cervical Fusion, Anterior S-320 (ISC)

Cervical Fusion, Posterior S-330 (ISC) Cervical Laminectomy S-340 (ISC) Lumbar Diskectomy, Foraminotomy, or Laminotomy S-810 (ISC) Lumbar Fusion S-820 (ISC) Lumbar Laminectomy S-830 (ISC)

The following spinal procedures are unproven and/or not medically necessary: Spinal fusion when performed via the following methods:

o Axial lumbar interbody fusion (AxiaLIF™) o Interlaminar lumbar instrumented fusion ( ILIF) (e.g., Coflex-F®)

o Laparoscopic anterior lumbar interbody fusion (LALIF)

o Transforaminal lumbar interbody fusion (TLIF) which utilizes only endoscopy visualization (such as a percutaneous incision with video visualization)

This includes interbody cages, screws and pedicle screw fixation devices with any of the above procedures. Clinical evidence is limited primarily to retrospective studies and case

series. Randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health outcomes



Oxford


REVISED

Surgical Treatment for Spine Pain (continued)

Apr. 1, 2018

edition, 2017” with “for applicable clinical coverage criteria, see

MCG™ Care Guidelines, 22nd edition, 2018”; refer to 22nd edition for

complete details on applicable updates to the MCG™ Care Guidelines


to reflect the most current references

and long-term efficacy. Spinal decompression and interspinous process decompression

systems o Interspinous process decompression (IPD) systems for the treatment

of spinal stenosis

o Minimally invasive lumbar decompression (MILD®) Current clinical evidence is insufficient to permit conclusions

about whether any beneficial effect from minimally invasive lumbar decompression provides a significant advantage over

surgical decompression. In addition, the complication rates and reoperation rates for this procedure compared with those of decompression surgery is unknown.

Spinal stabilization

o Stabilization systems for the treatment of degenerative

spondylolisthesis o Total facet joint arthroplasty, including facetectomy, laminectomy,

foraminotomy, vertebral column fixation The current published evidence is insufficient to determine

whether facet arthroplasty is as effective or as safe as spinal fusion, the current standard for surgical treatment of degenerative disc disease. In addition, no devices have received

approval from the U.S. Food and Drug Administration for use outside the clinical trial setting.

o Percutaneous sacral augmentation (sacroplasty) with or without a balloon or bone cement for the treatment of back pain The available clinical evidence shows that percutaneous

sacroplasty, may alleviate the pain and functional impairment of

sacral insufficiency fractures (SIF) in most patients with few and

predominantly minor adverse effects, suggesting that this procedure may be relatively safe and efficacious for treatment of SIF. Despite these promising findings, the overall quality of the body of evidence is low given that the available studies were limited by methodological flaws (e.g., retrospective design, small sample size, subjective outcome measures, lack of a control

group, and inadequate follow-up). Before reliable recommendations may be made, higher-quality studies are required that entail large populations with sufficient statistical



Oxford


REVISED

Surgical Treatment for Spine Pain (continued)

Apr. 1, 2018 power. Stand alone facet fusion without an accompanying decompressive

procedure o This includes procedures performed with or without bone grafting

and/or the use of posterior intrafacet implants such as fixation

systems, facet screw systems or anti-migration dowels. Clinical evidence is limited primarily to case series and nonrandomized studies. Randomized, controlled trials comparing facet fusion to standard procedures are needed to determine impact on health

outcomes and long-term efficacy.

Temporoman-dibular Joint Disorders

Apr. 1, 2018

Revised coverage rationale; replaced reference to “MCG™ Care Guidelines, 21st edition, 2017” with “MCG™ Care Guidelines, 22nd edition, 2018”

The following services are proven and/or medically necessary for treating disorders of the temporomandibular joint (TMJ): Arthrocentesis Arthroplasty [For information regarding medical necessity review, when

applicable, see MCG™ Care Guidelines, 22nd edition, 2018, Temporomandibular Joint Arthroplasty, ACG: A-0523 (AC)]

Arthroscopy (with or without FDA approved bone anchor devices) Arthrotomy/open joint surgery (with or without FDA approved bone

anchor devices) Injections of corticosteroids for rheumatoid arthritis-related TMJ

disorders Physical therapy

Stabilization and repositioning splint therapy (This does not include low-load prolonged-duration stretch (LLPS) devices discussed below)

Partial or total joint replacement with an artificial prosthesis is proven and/or medically necessary for treating disorders of the temporomandibular joint (TMJ) when all other treatments have

failed.

The following services are unproven and/or not medically necessary for treating disorders of the temporomandibular joint (TMJ): Biofeedback Craniosacral manipulation Passive rehabilitation therapy Low-load prolonged-duration stretch (LLPS) devices

There are limited studies evaluating biofeedback for the treatment of



Oxford


REVISED

Temporoman-dibular Joint Disorders

(continued)

Apr. 1, 2018 musculoskeletal pain, including TMJ pain. Well-designed randomized, blinded and placebo-controlled outcome studies published on craniosacral manipulation for TMJ are not available.

While there are some data from several randomized trials and case series studies that certain types of passive rehabilitation techniques may improve

jaw mobility early in recovery in patients who have undergone TMJ surgery, or have lost jaw mobility due to TMJ derangement or to contracture following radiation therapy, these studies all included very small numbers of patients, and did not provide blinded assessment of outcomes, long-term follow-up, or

information on optimal treatment protocols. Further prospective controlled clinical trials that directly compare LLPS devices to other treatment modalities are needed.

Total Knee Replacement Surgery

(Arthroplasty)


total knee replacement

surgery (arthroplasty) is proven and/or medically necessary in certain circumstances

o Replaced language indicating “for information regarding

medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017” with “for applicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd

edition, 2018”; refer to 22nd


Total knee replacement surgery (Arthroplasty) is proven and/or medically necessary in certain circumstances. For applicable clinical coverage criteria, see MCG™ Care Guidelines, 22nd edition, 2018, Total Knee

Arthroplasty, S-700 (ISC) and Musculoskeletal Surgery or Procedure GRG: SG-MS (ISC GRG).

Transcranial Magnetic Stimulation

Apr. 1, 2018


transcranial magnetic stimulation is unproven

and/or not medically

Transcranial magnetic stimulation is unproven and/or not medically necessary for treating all medical (i.e., non-behavioral) conditions including but not limited to: Alzheimer’s disease

Chronic neuropathic pain



Oxford


REVISED


(continued)

Apr. 1, 2018

necessary for treating Alzheimer’s disease

o Replaced language

indicating: “Transcranial magnetic

stimulation is unproven

and not medically necessary for treating all conditions including [those listed in the

policy]” with “transcranial magnetic stimulation is unproven and/or not medically necessary for treating all medical (i.e., non-

behavioral) conditions including but not limited

to [those listed in the policy]”

“Navigated transcranial magnetic stimulation (nTMS) is unproven and

not medically necessary for treatment planning or for diagnosing motor neuron diseases or neurological disorders” with “navigated

transcranial magnetic

stimulation (nTMS) is unproven and/or not medically necessary for treatment planning or for diagnosing motor neuron diseases or neurological

disorders” Updated list of applicable CPT

codes:

Dystonia Epilepsy Headaches

Parkinson's disease Stroke Tinnitus

For Behavioral Disorders, refer to the Optum Behavioral Solutions Coverage Determination Guideline titled Transcranial Magnetic Stimulation (TMS) at Optum Provider Express > Clinical Resources > Guidelines/Policies/Manuals

> Coverage Determination Guidelines. Some studies have examined the use of transcranial magnetic stimulation for treating disorders such as pain, dystonia, epilepsy, headaches, Parkinson’s disease, stroke, and tinnitus. However, because of limited studies and small sample size there is insufficient data to conclude that transcranial magnetic

stimulation is beneficial for treating these conditions.

Navigated transcranial magnetic stimulation (nTMS) is unproven and/or not medically necessary for treatment planning or for diagnosing motor neuron diseases or neurological disorders. There is limited information from the peer-reviewed published medical literature to conclude that navigated transcranial magnetic stimulation is an

effective clinical diagnostic test. Most published studies involve a small number of patients. Randomized controlled trials with large populations are needed to evaluate how this test can reduce clinical diagnostic uncertainty or impact treatment planning.

https://www.providerexpress.com/content/ope-provexpr/us/en/clinical-resources/guidelines-policies.html

https://www.providerexpress.com/content/ope-provexpr/us/en/clinical-resources/guidelines-policies.html



Oxford


REVISED


(continued)

Apr. 1, 2018 o Added 64999 o Removed 95999





Oxford

Policy Title Effective Date Administrative Guidelines

NEW

New York & Connecticut Participating

Surgeons Using Non- Participating Providers for

Intraoperative Neuro-Monitoring (IONM)

Jun. 1, 2018

NY and CT Participating Providers Using Non-Participating IONM Providers

The following procedures and responsibilities apply to Participating Providers located in NY and CT when providing services to members enrolled on NY and/or CT products in an outpatient or inpatient facility setting that involve intraoperative neuro-monitoring (IONM).

Services performed by a Participating Provider located in NY or CT and meeting the following criteria must ensure that the IONM provider utlized is participating with the Oxford network. Member is enrolled on a NY or CT product; and Service is being provided in an outpatient or inpatient facility setting; and Involve intraoperative neuro-monitoring (IONM). Outpatient and Inpatient Facility Place Codes

Place Code Description

15 Mobile diagnostic unit

19 Off campus - outpatient hospital

21 Inpatient Hospital

22 On campus - outpatient hospital

24 Ambulatory surgical center

99 Other unlisted factilty

If the Participating Provider intends to utilize an IONM provider that does not participate in the Oxford network, the provider is required to: Verbally discuss options and financial impact with the Member

o The Participating Provider must review this policy and the Non-Participating Provider Consent Form with the

Member. The discussion must explain Participating and Non-Participating IONM Provider alternatives and provide

the Member with an understanding of all the providers involved in the Member’s care. The discussion must include a conversation explaining the financial impact of using a Non-Participating

IONM Provider. A copy of the Non-Participating Provider Consent Form must be provided to the Member.

o The discussion must occur no more than 90 days, and no less than 14 days before, the scheduled date of the

procedure. o If the Member does not sign the form at the end of the discussion, explain that it needs to be completed and

returned no less than 14 days before the scheduled date of the procedure. o The discussion must then be noted in the Member’s medical record.



Oxford


NEW



Intraoperative Neuro-Monitoring (IONM) (continued)

Jun. 1, 2018

Obtain a completed Non-Participating Provider Consent Form o The member will need to agree or disagree to receive IONM services from a Non-Participating Provider by

marking the appropriate box on the Non-Participating Provider Consent Form. The member must then sign

and date the form and return the form to the Participating Provider no less than 14 days before the scheduled date of the procedure. If the Member: Does not agree to the use of a Non-Participating IONM Provider: Following the discussion, if the

Participating Provider: - Is unable to locate a Participating IONM Provider, they must contact the health plan for assistance in

locating a Participating IONM Provider. - Still wants to recommend the Non-Participating IONM Provider, they must contact Oxford to request

and initiate an In-Network Exception request. Does agree to the use of a Non-Participating IONM Provider: The Participating Provider must

ensure that the Member understands the financial obligations of using a Non-Participating IONM Provider. - For Members with out-of-network benefits: Non-Participating IONM Providers will be paid at the

out-of-network benefit level. Out-of-network cost shares and deductibles will apply. In addition,

Members may be responsible to the Non-Participating IONM Provider for any amount above the amount paid by the health plan, as determined by the Member’s out-of-network benefit; or

- For Members with only in-network benefits: Non-Participating IONM Provider claims will be denied because the Member has no coverage for services provided by Non-Participating Providers. Members will therefore be responsible for the entire cost of the service(s).

o The Participating Provider must then sign and date the form to acknowledge the Member’s decision. o The Non-Participating Provider Consent Form must be kept on file by the Participating Provider.

o A separate Non-Participating Provider Consent Form is required for every service when the Participating Provider wants to refer to or involve a Non-Participating IONM Provider in a member’s care.

o The Non-Participating Provider Consent Form will only be valid for 90 days from the date of member signature.

o Oxford may request a copy of the completed Non-Participating Provider Consent Form from the Participating Provider (who is required to keep the form on file) in order to conduct standard business.

When requested, the Participating Provider must provide a copy of the Non-Participating Provider

Consent Form within 15 days of the request. If a copy of the completed Non-Participating Provider Consent Form is not received within 15 days of the

request, the Participating Provider’s claim will be denied administratively for failure to comply with this protocol.

In these instances, the Participating Provider is prohibited from balance billing the Member. Any payment previously made for the surgical service will be subject to recovery. The Participating

provider cannot balance bill the member for claims denied for administrative reasons. Participating IONM Providers

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/oxford/nonpar-provider-consent-form-protocol-ohp.pdf



Oxford


NEW



Intraoperative Neuro-Monitoring (IONM) (continued)

Jun. 1, 2018 When a Participating Provider performs services in an outpatient or inpatient facility setting using a Participating IONM Provider, there will be no additional requirements to fulfill. A Non-Participating Provider Consent Form is not required.

Non-Compliance With This Policy

Oxford may request a copy of the completed Non-Participating Provider Consent Form from the Participating Provider (who is required to keep the form on file) in order to conduct standard business. When requested: The Participating Provider must provide a copy of the Non-Participating Provider Consent Form within 15 days of

the request. If a copy of the completed Non-Participating Provider Consent Form is not received within 15 days of the

request, as proof that they discussed the member’s options for selecting a Participating or Non-Participating IONM Provider, in advance of the service, the Participating Provider’s claim will be denied administratively for

failure to comply with the protocol. In these instances, the Participating Provider is prohibited from balance billing the member. Any payment

previously made for the service will be subject to recovery. The Participating Provider cannot balance bill the member for claims denied for administrative reasons.

In-Network Exception Requests

If requesting an In-Network Exception to have a Non-Participating IONM Provider covered as if they were participating with the Oxford network, the Participating Provider must make the exception request. The exception request will not be accepted from the Non-Participating IONM Provider.

The In-Network Exception request must be made no less than 14 days in advance of the scheduled procedure in order to avoid delays in care and alleviate potential complications with the patient’s required preparations for the procedure.

If the Participating Provider requests an In-Network Exception less than 14 days in advance of the scheduled procedure, the In-Network Exception request will be processed per Oxford’s standard guidelines, however the Participating Provider will receive an administrative denial for their claim for failure to follow protocol.

Policy Title Effective Date Summary of Changes Administrative Guidelines

UPDATED

Non-Participating Provider Consent Form Protocol

Mar. 1, 2018

Reformatted attachments/reference documents; transferred content to embedded PDF format (no change to policy guidelines)

In Advance of Any Services Being Rendered

You must verbally discuss Provider options and financial impacts with the member: o Review this policy and the Member Advance Notice Form with the

member. o Provide participating alternatives and explain the reason for the non-

participating provider. o Discuss the financial impact of utilizing a non-participating provider.



Oxford


UPDATED


(continued)

Mar. 1, 2018

If the member has out-of-network benefits, they may utilize those benefits to receive services from a non-participating provider, however; they may have higher out-of-pocket costs

when using a non-participating provider. Members that do not have out-of-network benefits may be

responsible for the entire cost of the service(s) provided by the

non-participating provider.

Impacted Provider/Service Types

o Ambulatory Surgical Centers (ASC); free-standing and hospital outpatient non-emergent

o Assistant surgeon: a physician or other health care professional who

is assisting the physician performing a surgical procedure, where the participating surgeon has influence/control over the selection of the assistant surgeon

o Home health o Air ambulance; fixed-wing non-emergency transport

o Laboratory services; for specimens collected in the physician’s office then sent out to a non-participating laboratory for processing

For Oxford New York products members, refer to the Oxford policy New York Participating Provider Laboratory & Pathology Protocol for specific requirements and instructions on non-participating laboratory and pathology services.

o Outpatient dialysis o Specialty drug vendor

Complete the Member Advance Notice Form

If the member elects to use a non-participating provider, complete the Member Advance Notice Form and obtain the member’s signature.

o The participating Provider must keep a copy of the signed form on file to present to Oxford upon request.

o A separate Member Advance Notice Form is required for each non-

participating provider/service. This Protocol does not apply in emergent situations or instances where the care provider or member has obtained an in-network exception to utilize a non-participating physician, facility or other healthcare provider. This Protocol is not intended to deter members from using out-of-network



Oxford


UPDATED


(continued)

Mar. 1, 2018 benefits, if available. Members who have out-of-network benefits can exercise their right to use those benefits at any time. Administrative Actions for Non-Compliance

Oxford will monitor the involvement of the non-participating provider types

and services outlined above in our member’s care and may request a copy of the completed Member Advance Notice Form at any time from providers with a pattern of non-participating provider utilization. Compliance with this Protocol will be reviewed by Oxford. Failure to comply with the Protocol may result in appropriate action according to the participation agreement, which may include, but is not limited to, ineligibility for performance based compensation, or termination of your participation agreement.


REVISED

Formula & Specialized Food

Apr. 1, 2018

Revised coverage rationale; updated coverage criteria for:

Connecticut (CT) and New Jersey (NJ) Plans o Replaced language indicating

“specialized formula will be authorized [for] one of the [listed] conditions” with “specialized formula will be authorized when the specialized formula is medically necessary for the

treatment of a disease or condition, including but not

limited to one [listed in the policy]”

New York (NY) Plans o Replaced language indicating

“enteral formulas which are

medically necessary and taken under written order from a physician for the treatment of specific

Oxford will cover specialized formula and specialized foods as outlined below.

Approved authorizations will be issued for one year. CT and NJ Plans

Specialized Formula

Specialized formula will be authorized when all of the following criteria, one of the conditions, and all of the documentation requirements are met: Criteria:

o A physician prescribes the therapy; and

o The condition is chronic and is expected to last for an undetermined or prolonged period of time; and

o Adequate nutrition is not possible by dietary adjustment; and

o Nutritional therapy is provided as replacement therapy; and o The material used is specially formulated as a nutrition replacement;

and

Individuals who will become malnourished or suffer from severe disorders such as physical disability, mental retardation or death if the medical nutritional therapy is not instituted;

and The specialized formula is medically necessary for the treatment

of a disease or condition, including but not limited to one of the following:



Oxford


REVISED

Formula & Specialized Food (continued)

Apr. 1, 2018

diseases shall be distinguished from nutritional supplements

taken electively” with “enteral formulas (prescription or non-

prescription) which are deemed medically necessary and written under order from a physician for the treatment

of specific diseases shall be distinguished from nutritional supplements taken electively”

o Added language to indicate nutritional formulas will be

authorized for the treatment of phenylketonuria,

branched-chain ketonuria, galactosemia, and homocystinuria


description of services and references

o Inborn error of metabolism; or o Inherited diseases of amino-acid or organic acid metabolism; or o Crohn's disease; or

o Disorders of gastrointestinal motility such as chronic intestinal pseudo-obstruction; or

o Severe malabsorptive syndrome; or

o Severe food allergies which if left untreated will cause malnourishment, chronic physical disability, mental retardation or death; or Note: See documentation required for severe food allergy.

o GE reflux with Failure to Thrive Note: See documentation required for GE reflux with Failure to Thrive.

and Required documentation:

o For multiple food allergy:

Consultation with relevant specialist (Neonatologist, Gastroenterologist or Allergist); and

Note: A consultation by a specialist is not required for NJ plans. A requests from the covered infant's physician is sufficient.

Diagnosis of multiple food protein allergy; and Note: Multiple food protein intolerance is also acceptable for NJ plans.

Office notes indicating failure to tolerate due to severe allergic reaction, or contraindication to available standard: - Standard cow milk based formula; and - Non-cow milk based formula, (including soybean)

o For GE reflux with Failure to Thrive: Consultation with relevant specialist (gastroenterologist or

neonatologist); and

Note: A consultation by a specialist is not required, for NJ plans. Requests from the covered infant's physician is sufficient.

Diagnosis of GE reflux WITH Failure to Thrive. Failure to Thrive is defined as a child: - Growing below 3rd or 5th percentile; or - Whose decreased growth has crossed 2 major growth

percentiles); and Office notes indicating failure to tolerate due to severe allergic

reaction or contraindication to available standard:



Oxford


REVISED


Apr. 1, 2018

- Cow milk based formula; and - Non-cow milk based formula, (including soybean)

Specialized Foods

Specialized foods (including low protein and amino acid modified food or

formula) are covered for inborn errors of metabolism, which includes, but is not limited to, Homocystinuria, Maple syrup urine disease, methylmalonic aciduria, phelylketonuria (PKU), Tyrosinemias, certain inherited diseases of amino acid and organic acid metabolism, and Cystic Fibrosis. Note: Specialized food for members with a diagnosis of Cystic Fibrosis is covered for CT Commercial plans only.

NY Plans

Enteral Formulas

Enteral formulas (prescription or non-prescription) which are deemed

medically necessary and written under order from a physician for the

treatment of specific diseases shall be distinguished from nutritional supplements taken electively. Enteral formula or modified solid food products will be authorized based on all of the following criteria: Being used as part of disease specific treatment; and

Treatment is for one of the following: o Inherited diseases of amino acid and/or organic acid metabolism o Crohn’s Disease o Gastroesophageal reflux disease with Failure to Thrive o Disorders of gastrointestinal motility such as chronic intestinal

pseudo-obstruction

o Multiple, severe food allergies

and One of the following:

o Patient is malnourished o Patient will become malnourished without treatment o If patient’s condition is left untreated it will cause one of the

following:

Chronic physical disability Mental retardation Death



Oxford


REVISED


Apr. 1, 2018

Nutritional Formulas

Nutritional formulas will be authorized for the treatment of phenylketonuria, branched-chain ketonuria, galactosemia, and homocystinuria.

In-Network

Exceptions for

Breast Reconstruction Surgery Following Mastectomy

Apr. 1, 2018 Changed policy type

classification from “Clinical” to

“Administrative” Revised list of services eligible

for in-network exception request; added CPT codes 19330, 19342, and 19355

Reformatted attachment file

(Non-Participating Provider Consent Form); transferred content to embedded PDF format

Refer to the policy for complete details on In-Network Exceptions for Breast

Reconstruction Surgery Following Mastectomy.

Newborns

Apr. 1, 2018

Revised procedures and responsibilities:

o Updated language pertaining to New Jersey (NJ) plan

members: Changed timeframe for

automatic newborn/newly born adopted child coverage with no premium

requirement from “first 31 days” to “first 60 days”

Changed enrollment

period for a newborn/newly born adopted child for

members without family or parent/child coverage from “initial 31 day period in order for coverage to continue beyond the 31 days” to

Refer to the policy for complete details on the processes for the enrollment and coverage Newborns.



Oxford


REVISED

Newborns (continued)

Apr. 1, 2018 “initial 60 day period in order for coverage to continue beyond the 60

days” o Updated language pertaining

to New York (NY)

members on OHP and OHI plans when a newborn is not automatically covered as of their date of birth; replaced

language indicating “the member must submit the required proof specifically adding the newborn child and the required premium within 30 days of the date of

birth” with “the member must submit the required

proof specifically adding the newborn child and the required premium within 31 days of the date of birth”



Precertification Exemptions for Outpatient Services

Apr. 1, 2018 Revised list of CPT codes for Pathology and Laboratory services that do not require precertification in the office or

outpatient setting; removed

81520 and 81521 (refer to the policy titled Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions for applicable coverage guidelines)

Refer to the policy for complete details on Precertification Exemptions for Outpatient Services.

Referrals

Apr. 1, 2018

Updated list of related policies to

reflect title change for Genetic

Refer to the policy for complete details on the administrative guidelines for

Referrals.



Oxford


REVISED

Referrals (continued)

Apr. 1, 2018

Testing for Hereditary Cancer [previously titled Genetic Testing for Hereditary Breast and/or

Ovarian Cancer Syndrome (HBOC)]

Revised procedures and

responsibilities: o Modified langauge pertaining

to how Referrals are submitted to indicate a

Referral can be submitted via phone, EDI or online at OxfordHealth.com; refer to the UnitedHealthcare Provider Administrative Guide, including the Oxford

Commercial Supplement, for additional details

o Updated exceptions to Referral requirements; modified list of related policies for laboratory services that may require

precertification: Added reference links to

policies titled: - Gene Expression

Tests for Cardiac Indications

- Genetic Testing for

Hereditary Cancer - Molecular Oncology

Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions

- Pharmacogenetic Testing

- Whole Exome and



Oxford


REVISED

Referrals (continued)

Apr. 1, 2018 Whole Genome Sequencing

Removed reference links

to policies titled: - Gene Expression

Tests

- Genetic Testing - Genetic Testing for

Hereditary Breast and/or Ovarian

Cancer Syndrome (HBOC)

- Molecular Profiling to Guide Cancer Treatment





Oxford

Policy Title Effective Date Reimbursement Guidelines

NEW

Multiple Procedure Payment Reduction (MPPR) for

Diagnostic Imaging

Apr. 1, 2018

Multiple Diagnostic Imaging Reductions (MDIR)

Oxford utilizes the CMS NPFS MPI of 4 and Non-Facility Total Relative Value Units (RVUs) to determine which radiology procedures are eligible for MDIR. Different MDIR percentages apply to the PC and TC portion of global services.

MDIR applies when: Multiple diagnostic imaging procedures with a MPI of 4 are performed on the same patient by the Same Group

Physician and/or Other Health Care Professional during the Same Session. A single imaging procedure subject to MDIR is submitted with multiple units. For example, code 73702 is

submitted with 2 units. MDIR would apply to the second unit. The units are also subject to Oxford's Maximum Frequency Per Day policy.

MDIR will not apply when: The diagnostic imaging procedure is the primary procedure as ranked based on the RVU assigned to the code

(and modifier, when applicable), compared to other diagnostic imaging procedures billed during the Same Session.

Multiple diagnostic imaging procedures are billed, appended with Modifier 59 or Modifier XE to indicate the

procedure was performed on the same day but not during the Same Session. Multiple diagnostic imaging procedures are billed for the same patient on the same day but not by the Same

Group Physician and/or Other Health Care Professional during the Same Session. The imaging service does not have an MPI of 4. See the Diagnostic Imaging Procedures Subject to Multiple

Imaging Reduction Lists in the Attachments section of the policy. Multiple Diagnostic Imaging Reduction Percentages

When the TC for two or more imaging procedures subject to MDIR are performed on the same patient by the Same Group Physician and/or Other Health Care Professional during the Same Session, Oxford will reduce the Allowed Amount for the TC of the second and each subsequent procedure by 50%. Oxford will regard the TC portion of the

procedure(s) with the lower TC total RVUs, as subject to MDIR.

In addition, when the PC for two or more imaging procedures subject to MDIR are performed on the same patient by the Same Group Physician and/or Other Health Care Professional at the Same Session, Oxford will reduce the Allowed Amount for the PC of the second and each subsequent procedure by 5% . The reduction is applied to the Allowed Amount for the PC component of the second and subsequent procedures. Oxford will regard the PC portion of the procedure(s) with the lower PC total RVUs, as subject to MDIR.

Multiple Diagnostic Imaging Procedures Billed Globally

When a provider bills globally for two or more procedures subject to MDIR, for a patient at the Same Session, the charge for the Global Procedure Codes will be divided into the PC and TC (indicated by modifiers 26 and TC) using Oxford's standard Professional/Technical percentage splits. The RVUs assigned to each component (26 or TC) will



Oxford

Policy Title Effective Date Reimbursement Guidelines

NEW

Multiple Procedure Payment Reduction (MPPR) for

Diagnostic Imaging (continued)

Apr. 1, 2018 determine which code will be ranked as primary, with no reduction applied, and those that will be ranked as secondary or subsequent, with reductions applied in accordance with this policy. The components (26 or TC) will be ranked independently of each other utilizing the CMS Non-Facility Total RVUs.

Policy Title Effective Date Summary of Changes Reimbursement Guidelines

UPDATED

After Hours and Weekend Care

Apr. 1, 2018

Updated policy application guidelines; added language to

clarify this policy applies to: o Services reported using the

1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form

o All products

The Centers for Medicare and Medicaid Services (CMS) considers reimbursement for Current Procedural Terminology (CPT®) codes 99050,

99051, 99053, 99056, 99058 and 99060 to be bundled into payment for other services provided on the same day.

CPT Codes 99051, 99053, 99056, 99058, or 99060 Consistent with CMS and with the intent of this policy, Oxford will not separately reimburse CPT codes 99051, 99053, 99056, 99058 or 99060.

CPT Code 99050

Although CMS considers CPT code 99050 to be bundled into the payment for other services provided on the same day, Oxford will provide additional compensation to participating primary care providers for seeing patients in situations that would otherwise require more costly urgent care or emergency room settings by reimbursing CPT code 99050 in addition to basic service codes.

Oxford will reimburse after hours CPT code 99050 to participating primary care providers when reported with basic services in one of the following CMS non-facility place of service (POS) designations only:

POS Code Description

03 School

05 Indian health service free-standing facility

07 Tribal 638 free-standing facility

11 Office

49 Independent clinic

50 Federally qualified health center



Oxford


UPDATED

After Hours and Weekend Care (continued)

Apr. 1, 2018 71 State or local public health clinic

72 Rural health clinic

Oxford will reimburse the following participating primary care providers for CPT 99050:

Adolescent medicine, pediatric-adolescent, pediatrics

Family nurse practitioner, nurse practitioner, pediatric nurse practitioner, advanced registered nurse practitioner

Family practice General practice Geriatric medicine Gynecology, obstetrics & gynecology, obstetrics Internal medicine

Certified nurse midwife

Evaluation and Management (E/M)

Mar. 1, 2018

Routine review; no content changes

All E/M Services

When assigning an E/M Level of Service for a patient Encounter, significant

factors to consider are the nature of the presenting problem (NoPP) and the complexity of medical decision making (MDM). The expectation of documentation necessary to substantiate the claim as billed will follow the general principles of medical record documentation which apply to all types of medical and surgical services in all settings. While

E/M services vary in several ways, such as the nature and amount of physician work required, the following general principles help ensure that medical record documentation for all E/M services is appropriate: The medical record should be complete and legible; The documentation of each patient Encounter should include but not be

limited to:

o Reason for the Encounter and relevant history, physical examination

findings, and prior diagnostic test results; o Assessment, clinical impression, or diagnosis; o Medical plan of care; o Date and legible identity of the observer; o If not documented, the rationale for ordering diagnostic and other

ancillary services should be easily inferred; o Past and present diagnoses should be accessible to the treating

and/or consulting physician; o Appropriate health risk factors should be identified;



Oxford


UPDATED

Evaluation and Management (E/M) (continued)

Mar. 1, 2018

o The patient’s progress, response to and changes in treatment, and revision of diagnosis should be documented;

o The diagnosis and treatment codes reported on the health insurance

claim form or billing statement should be supported by documentation in the medical record;

o Review of past medical records must include a summary of relevant

information gleaned from this review in order to receive credit in the Amount and Complexity of Data section.

While there is no prohibition on the use of proprietary templates,

documentation from either an electronic health record (EHR) or hard-copy that appears to be cloned (selected information from one source and replicated in another location by copy/paste methods) from another record, including but not limited to history of present illness (HPI), exam, and MDM, would not be acceptable documentation to support the claim as billed.

For example, HPI should be the provider’s individual description of the development of the patient’s present illness from the first sign and/or

symptom, or from the previous Encounter to the present; the exam should be the individual description of the patient’s exam at the time of the Encounter and MDM should also be individualized to the Encounter for the patient to outline a specific assessment and plan of care.

Medical record documentation should be provided upon request. E/M Services Performed in an Emergency Department (ER/ED) Place of Service

CPT codes 99281-99285 are used to report E/M services rendered in an ER/ED place of service. Evaluating for level of care appropriateness for these

codes in an ER/ED place of service includes a review of the tests and management options that are available to be performed during the initial visit.

The 1995 CMS Documentation Guidelines state that the number of diagnoses and management options that must be considered "...is based on the number and types of problems addressed during the Encounter, the complexity of establishing a diagnosis and the management decisions that are made by the physician." Additional Work-Up Planned is an element of review which includes a number of diagnoses and management options. The



Oxford


UPDATED

Evaluation and Management (E/M) (continued)

Mar. 1, 2018 Additional Work-Up Planned” element contributes to indicating the complexity of a patient based on the clinician's utilization of diagnostic tests. Oxford utilizes the industry standard guidelines to determine the appropriate

level of care is as follows:

Number of Diagnoses and Management Options Points Assigned

Self-Limiting or Minor Problems (Stable, Improved or Worsening). Max of 2 points can be given

1

Established Problem – Stable Improved 1

Established Problem – Worsening 2

New Problem – No Additional Work-Up Planned. Max of 1 point can be given

3

New Problem – Additional Work-Up Planned 4

A provider receives 3 points for “New Problem, No Additional Work-Up

Planned,” and 4 points for “New Problem, Additional Work-Up Planned.” This

one-point difference can affect whether a level 4 or level 5 code is appropriate. Please note that all Encounters with ED patients are considered “New Problem” Encounters for purposes of scoring. An example of Additional Work-Up Planned, is if the physician schedules testing him/herself or communicates directly with the patient’s primary

physician or representative the need for testing which is to be done after discharge from the ED, and the appropriate documentation has been recorded. Credit for “Additional Work-up” Planned is granted (4 points assigned). Credit is not given for the work up if it occurs during the ER Encounter. This interpretation is consistent with the level 5 code description that “…Usually, the presenting problem(s) are of high severity and pose an

immediate significant threat to life or physiologic function…”. Patients

admitted to the hospital under the care of a physician other than the ER physician may have testing done as part of the admitting physician’s care for that patient. The ER physician will not receive credit for the Additional Work-Up Planned done under the care of the admitting physician. Routine review; no content changes

Increased Procedural Services

Mar. 1, 2018

Updated list of related policies; added reference link to policy

titled Robotic Assisted Surgery

Oxford's standard for additional reimbursement of Modifier 22 (increased procedural services) and/or Modifier 63 (procedures performed on infants

less than 4 kg) is 20% of the Allowable Amount for the unmodified



Oxford


UPDATED

Increased Procedural Services (continued)

Mar. 1, 2018

procedure, not to exceed the billed charges. Claims submitted with these modifiers must include medical record documentation which supports the use of the modifiers and which will be reviewed by Oxford in accordance with this

policy. Note: When both Modifier 22 and Modifier 63 are appended to the same CPT

code, reimbursement will be a total of an additional 20% of the Allowable Amount of the unmodified procedure, not to exceed the billed charges, provided the documentation supports use of either Modifier 22 or Modifier 63.

Refer to the Obstetrical Policy for information on the use of Modifier 22 with obstetrical services. Modifier 22 - Increased Procedural Services

In order to be considered for additional reimbursement when reporting Modifier 22, thorough medical records or reports and a separate document

containing a concise statement about how the service differed from the usual service or procedure is required. The documents must indicate the

substantial additional work performed and the reason for the additional work which may include, but not be limited to, increased intensity or time, technical difficulty of procedure that is not described by a more comprehensive procedure code, severity of the patient’s condition, or increased physical and mental effort required.

Additional reimbursement will only be considered for services appended with Modifier 22 that are assigned a global period of 0, 10, 42 or 90 days. Modifier 22 should not be appended to an evaluation and management service. Refer to the “Global Days Policy” for a listing of those codes with a global day

period. Modifier 63 - Procedure Performed on Infants Less Than 4 kg

In order to be considered for additional reimbursement when reporting Modifier 63, thorough medical record(s) or report(s) that support the use of

the modifier is required. The document(s) must indicate the substantial additional work performed and the reason for the additional work which may include, but not be limited to, increased intensity or time, technical difficulty of procedure that is not described by a more comprehensive procedure code, severity of the patient’s condition, or increased physical and mental effort



Oxford


UPDATED

Increased Procedural Services (continued)

Mar. 1, 2018 required.

Unless otherwise designated, this modifier may only be appended to procedures/services listed in the 20005-69990 code series. Modifier 63 should not be appended to any CPT code listed in the Evaluation and Management Services, Anesthesia, Radiology, Pathology/Laboratory, or

Medicine sections.

Modifier SU Apr. 1, 2018 Updated policy application guidelines; added language to

clarify this policy applies to services reported using the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form

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 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.

Nonphysician Health Care Codes

Apr. 1, 2018

Updated policy application guidelines; added language to clairfy this policy applies to: o Services reported using the

1500 Health Insurance Claim Form (a/k/a CMS-1500) or

its electronic equivalent or its successor form

o All products

The American Medical Association Current Procedural Terminology (CPT®) Professional Edition gives the following instruction for code selection: “Select the name of the procedure or service that accurately identifies the service performed. Do not select a CPT code that merely approximates the service provided.”

The American Medical Association (AMA) has developed specific CPT codes intended for use by qualified health care professionals who are not Physicians to report their services. In some instances the intended use of a procedure or service is within the description of the code. For example CPT 98960 describes education and training for patient self-management by a qualified, nonphysician health care professional. In other instances the AMA has included parenthetical information in the CPT book as with CPT 96040 which

says “These services are provided by trained genetic counselors and may include obtaining a structured family genetic history, pedigree construction,



Oxford


UPDATED

Nonphysician Health Care Codes (continued)

Apr. 1, 2018 analysis for genetic risk assessment, and counseling of the patient and family.”

Conversely, the AMA instructs Physicians who provide genetic counseling and education, risk factor reduction intervention or medical nutrition therapy to use the appropriate evaluation and management codes to report these

services. Existing evaluation and management codes include services such as taking a patient’s health and family history and counseling.

Therefore, in accordance with correct coding guidelines, Oxford will not reimburse nonphysician health care professional service codes (listed in the Applicable Codes section of the policy) when reported by a Physician, because these codes are intended for use by nonphysician health care professionals. Physicians who provide genetic counseling, health and behavior assessment/intervention, medical nutrition therapy or education

and training for patient self-management should report these services using evaluation and management codes.

Observation Care Evaluation and Management Codes

Apr. 1, 2018

Updated policy application guidelines; added language to clarify: o This policy applies to:

Services reported using

the 1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form

All products o This policy does not apply to

claims billed on the UB-04 form

Initial Observation Care

The physician supervising the care of the patient designated as "observation status" is the only physician who can report an initial Observation Care CPT code (99218-99220). It is not necessary that the patient be located in an observation area designated by the hospital, although in order to report the Observation Care codes the physician must: Indicate in the patient's medical record that the patient is designated or

admitted as observation status; Clearly document the reason for the patient to be admitted to

observation status; and Initiate the observations status, assess, establish and supervise the care

plan for observation and perform periodic reassessments.

The CPT codebook states that "When "observation status" is initiated in the

course of an encounter in another site of service (e.g., hospital emergency department, office, nursing facility) all evaluation and management services provided by the supervising physician or other qualified health care professional in conjunction with initiating "observation status" are considered part of the initial Observation Care when performed on the same date. The Observation Care level of service reported by the supervising physician

should include the services related to initiating "observation status" provided in the other sites of services as well as in the observation setting."



Oxford


UPDATED


(continued)

Apr. 1, 2018

Oxford follows the Centers for Medicare and Medicaid Services' (CMS) Claims Processing Manual which provides the instructions, "for a physician to bill the initial Observation Care codes [99218-99220], there must be a medical

observation record for the patient which contains dated and timed physician's admitting orders regarding the care the patient is to receive while in observation, nursing notes, and progress notes prepared by the physician

while the patient was in observation status. This record must be in addition to any record prepared as a result of an emergency department or outpatient clinic encounter."

Consistent with CMS guidelines, Oxford requires that an Initial Observation Care CPT code (99218-99220) should be reported for a patient admitted to Observation Care for less than 8 hours on the same calendar date. Subsequent Observation Care

In the instance that a patient is held in observation status for more than two calendar dates, the supervising physician should utilize a subsequent

Observation Care CPT code (99224-99226). Physicians other than the supervising physician providing care to a patient designated as "observation

status" should report subsequent Observation Care. According to the CPT codebook, “All levels of subsequent Observation Care include reviewing the medical record and reviewing the results of diagnostic studies and changes in the patient's status (i.e., changes in history, physical conditions, and response to management) since the last assessment.”

Observation Care Discharge Services

Per CPT, Observation Care discharge day management CPT code 99217 "includes final examination of the patient, discussion of the hospital stay,

instructions for continuing care and preparation of discharge records." Observation Care discharge services include all E/M services on the date of discharge from observation services and should only be reported if the discharge from observation status is on a date other than the date of initial

Observation Care. Oxford follows CMS guidelines that physicians should not report an Observation Care discharge Service when the Observation Care is a minimum of 8 hours and less than 24 hours and the patient is discharged on



Oxford


UPDATED


(continued)

Apr. 1, 2018 the same calendar date. Observation Care Admission and Discharge Services on Same Date

Physicians who admit a patient to Observation Care for a minimum of 8 hours, but less than 24 hours and subsequently discharge on the same

calendar date shall report an Observation or Inpatient Care Service (Including Admission and Discharge Services) CPT code (99234-99236). In accordance with CMS' Claims Processing Manual, when reporting an Observation Care admission and discharge service CPT code (99234-99236) the medical record must include: Documentation meeting the E/M requirements for history, examination

and medical decision making; Documentation stating the stay for hospital treatment or Observation

Care status involves 8 hours but less than 24 hours; Documentation identifying the billing physician was present and

personally performed the services; and

Documentation identifying that the admission and discharge notes were written by the billing physician.

Observation Care Services During a Surgical Period

Observation Care codes are not separately reimbursable services when performed within the assigned global period as these codes are included in the global package. Refer to the Oxford policy titled Global Days for guidelines on reporting services during a global period.

Obstetrical Policy

Apr. 1, 2018

Updated policy application

guidelines; added language to clarify this policy applies to: o Services reported using the

1500 Health Insurance Claim Form (a/k/a CMS-1500) or its electronic equivalent or its successor form

o All products Updated Questions & Answers

(Q&A):

Refer to the Obstetrical Policy for complete details on applicable coverage

guidelines.



Oxford


UPDATED

Obstetrical Policy (continued)

Apr. 1, 2018 o Modified Q&A #7; updated list of CPT codes for contraceptive management

services that are separately reimbursable during the postpartum period:

Added 11981 Removed 11975

o Modified Q&A #9; replaced reference to “provider” with

“physician”

Standby Services

Apr. 1, 2018 Updated policy application guidelines; removed language indicating this policy applies to: o Services reported using the

UB-04 Claim Form o Hospitals and ambulatory

surgical centers

Centers for Medicare and Medicaid Services

The Centers for Medicare and Medicaid Services (CMS) does not reimburse for physician standby services. These services are considered by CMS to be included in the payment to a facility as part of providing quality care and are not separately reimbursable. Standby Services

In accordance with CMS, Oxford does not reimburse physician or other qualified health care professional standby services submitted with CPT code 99360. If a specific service is directly rendered to the patient by the standby

physician or other qualified health care professional (i.e., tissue examination of frozen section biopsy), the service or procedure would be reported under the appropriate CPT code (i.e., 88331). Mandated Hospital On-Call Service

Oxford does not reimburse for hospital mandated on-call services billed under CPT codes 99026 and 99027 because they do not involve direct

patient contact.

Wrong Surgical or Other Invasive

Procedures

Mar. 1, 2018

Routine review; no content changes

Similar to any other patient population, Oxford members experience serious injury and/or death if wrong surgeries are performed and may require

additional healthcare in order to correct adverse outcomes resulting from such errors.

This Oxford reimbursement policy is based on information stated by CMS in its National Coverage Decision (NCD) 140.6 for Wrong Surgical or Other

Invasive Procedure Performed on a Patient and is in alignment with the Leapfrog Group and the National Quality Forum (NQF) position on Serious



Oxford


UPDATED

Wrong Surgical or Other Invasive Procedures

(continued)

Mar. 1, 2018

Reportable Events in Healthcare. For more information see the NQF and Leapfrog Group websites in the References section of the policy.

Oxford will not reimburse for a Wrong Surgical or Other Invasive Procedure Performed on a Patient when the physician or other healthcare professional erroneously performs: 1) a different procedure altogether; 2) the correct

procedure but on the wrong body part; or 3) the correct procedure but on the wrong patient. Oxford will not reimburse for related services associated with these Wrong Surgical or Other Invasive Procedures Performed on a Patient.

Related services which will not be reimbursed include: All services provided in the operating room related to the error All providers in the operating room when the error occurs, who could bill

individually for their services All related services provided during the same hospitalization in which the

error occurred

The rendering physician and all other providers performing services related to the erroneously performed procedure are expected to waive all costs associated with the Wrong Surgical or Other Invasive procedure. Participating providers may not bill or collect payment from Oxford members for any amounts not paid due to the application of this reimbursement policy.

Related services do not include: Services provided following hospital discharge, regardless of whether

they are related to the surgical error Performance of the correct procedure Submission of Claims

Consistent with CMS billing requirements, Oxford requires the reporting of these Wrong Surgery or Other Invasive Procedures Performed on a Patient in

the manner described below. Hospital Inpatient Claims

Hospitals are required to submit a no-pay claim (Type of Bill 110) to report all charges associated with the erroneous surgery. However, if there are also non-related services/procedures provided during the same stay as the erroneous surgery, hospitals are then required to submit two claims, one



Oxford


UPDATED

Wrong Surgical or Other Invasive Procedures

(continued)

Mar. 1, 2018

claim with services or procedures unrelated to the erroneous surgery and the other claim with the erroneous services/procedures as a no-pay claim.

The non-covered Type of Bill 110 must have one of the following ICD-10-CM diagnosis codes reported on the hospital claim to identify the type of erroneous surgery performed. These codes shall not be reported in the

External Cause of Injury (E-code) field. Y65.51 - Performance of wrong procedure (operation) on correct patient Y65.52 - Performance of procedure (operation) on patient not scheduled

for surgery

Y65.53 - Performance of correct procedure (operation) on wrong side of body parts

Hospital Outpatient, Ambulatory Surgery Center (ASC), and Professional/1500 Claims

Outpatient, ASCs and physicians or other health care professionals must report the applicable HCPCS modifier(s) with the associated charges on all

lines related to the surgical error: PA: Surgery Wrong Body Part

PB: Surgery Wrong Patient PC: Wrong Surgery on Patient


REVISED

B Bundle Codes

Apr. 1, 2018

Revised B Bundle Code List (attachment file listing codes assigned status code “B” and

included in Oxford’s B Bundle Codes Policy); removed CPT

code 99091

All codes published on the NPFS Relative Value File are assigned a status code. The status code indicates whether the code is separately payable if the service is covered. Per the public use file that accompanies the NPFS Relative

Value File, the following is stated for the status code B: "Payment for covered services is always bundled into payment for other

services not specified. If RVUs are shown, they are not used for Medicare payment. If these services are covered, payment for them is subsumed by the payment for the services to which they are incident. (An example is a telephone call from a hospital nurse regarding care of a patient)."

Consistent with CMS, Oxford will not separately reimburse for specific Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) codes assigned a status code “B” on the NPFS Relative Value File indicating a bundled procedure. B Bundle Codes are not



Oxford


REVISED

B Bundle Codes (continued)

Apr. 1, 2018 reimbursable services regardless of whether they are billed alone or in conjunction with other services. The codes which Oxford has included in this policy (for which separate reimbursement is not made) can be found in the

Attachments section of the policy.

Drug Testing

Mar. 1, 2018

Notice of Revision: The following

summary of changes has been modified. The revisions noted in red below will not be applied on Mar. 1, 2018 as previously announced. Please take note of the amended

guidelines to be implemented on Mar. 1, 2018. Updated policy overview; added

language to indicate this policy defines daily and annual limits for presumptive (CPT® codes

80305, 80306, and 80307) and definitive drug testing (HCPCS codes G0480, G0481, G0482, G0483 and G0659) and addresses Specimen Validity Testing

Revised reimbursement guidelines; added language to indicate: o This policy provides annual

units of service (UOS) limits o For Connecticut (CT) Small

and Large Group plans, an

annual frequency UOS limitation of 18 dates of service will be applied for presumptive drug testing In addition, an annual

frequency UOS limitation of 18 dates of service

will be applied for definitive drug testing

This policy enforces the code description for presumptive and definitive drug

testing in that the service should be reported once per day and it includes specimen validity testing. Clinical drug testing is used in pain management and in substance abuse screening and treatment programs. The testing may be used to detect

prescribed, therapeutic drugs, prescription drugs of abuse, illicit drugs, and/or other substances such as nicotine. Presumptive drug testing, also known as drug screening, is used when necessary to determine the presence or absence of drugs or a Drug Class. Results are expressed as negative or positive. The methodology is considered when coding presumptive procedures. Per CPT guidelines each presumptive

drug testing code represents all drug and Drug Class tests performed by the respective methodology per date of service. The test is a single per patient service that should only be reported once irrespective of the number of Drug Class procedures or results on any date of service. Definitive drug testing, also known as confirmation testing, is used when it is

necessary to identify specific medications, illicit substances and metabolites. Definitive urine drug test (UDT) reports the results of drugs absent or present in concentrations of ng/ml. Definitive drug testing is qualitative or quantitative to identify possible use or non-use of a drug. These tests identify specific drugs and associated metabolites. A presumptive drug test is not required to be provided prior to a definitive drug test. Consistent with

CMS, definitive drug testing CPT codes 80320-80377 and H0003 are

considered non-reimbursable and the appropriate HCPCS G0480-G0483,G0659, 0006U, 0007U, 0011U and 0020U should be reported. The HCPCS codes describe a per day service that represents the total number of different Drug Classes performed. Some examples of drugs or a Drug Class that are commonly assayed by presumptive tests, followed by definitive testing are: alcohols,

amphetamines, barbiturates/sedatives, benzodiazepines, cocaine and metabolites, methadone, antihistamines, stimulants, opioid analgesics,



Oxford


REVISED

Drug Testing (continued)

Apr. 1, 2018 These limits are applied whether services are applied by the same or

different providers o Drug testing services that

are determined to be court

ordered and/or funded by a county, state or federal agency will continue to be denied; for additional

information refer to the policy titled Services and Modifiers Not Reimbursable to Healthcare Professionals

Updated Questions & Answers (Q&A); added Q&A #4

addressing reimbursement for multiple presumptive and/or

definitive drug tests submitted on the same date of service for CT members

salicylates, cardiovascular drugs, antipsychotics, and cyclic antidepressants. In accordance with the code descriptions and the CPT and CMS guidelines,

Oxford will only allow one drug test within the presumptive Drug Class and one drug test within the definitive Drug Class per date of service by the same or different provider.

Specimen Validity Testing to assure that a specimen has not been compromised or that a test has not been adulterated may be required. However, Specimen Validity Testing is included in the presumptive and

definitive drug testing CPT and HCPCS code descriptions and is considered a quality control which is an integral part of the collection process and is not separately reimbursable. Oxford will deny Specimen Validity Testing when performed on the same date of service as a presumptive and/or definitive drug test by the same or different provider. A modifier may be appropriate when a service commonly used for Specimen Validity Testing is performed

distinctly separate from the drug test service and the documentation supports the service was not related to the drug testing.

Drug testing services that are determined to be court ordered and/or funded by a county, state or federal agency will continue to be denied. For additional information, refer to the policy titled Services and Modifiers Not Reimbursable to Healthcare Professionals.

Reimbursement for Comprehensive and Component CPT Codes (CES)

Mar. 1, 2018

Revised procedures and responsibilities: o Replaced language indicating

“to rebundle a claim, Oxford claims system utilizes a software package assembled

by IntelliClaim (owned by

McKesson Health Solutions)” with “to rebundle a claim, Oxford claims system utilizes a claims editing software product called Optum™ Claims Editing System (CES)”

o Removed language indicating:

When two or more related procedures are performed on a patient during a single session or visit, Oxford will reimburse the provider for the comprehensive code and deny or adjust the component, incidental or Mutually Exclusive Procedure performed during the same session. The Rebundling guidelines in this policy are based on The Correct Coding Initiative administered through the Centers for Medicare & Medicaid Services

(CMS), AMA Current Procedural Terminology (CPT Code) and additional

general industry accepted guidelines. To rebundle a claim, Oxford claims system utilizes a claims editing software product called Optum™ Claims Editing System (CES). Optum™ Claims Editing provides an extensive set of core rules that utilize historical data to maximize auditing capabilities for claims. This system features flexible editing functions and complete customization capabilities that allow Oxford to

develop, customize and update our payment guidelines as necessary. CES contains edits for both professional and facility claims that are specific to



Oxford


REVISED

Reimbursement for Comprehensive and Component CPT

Codes (CES) (continued)

Mar. 1, 2018

IntelliClaim's product provides a platform on which two off-the-shelf

and widely used products (referenced below) are combined

with a flexible environment that allows Oxford to develop, customize & update our

payment guidelines as necessary

Through their product, the efficiency, accuracy and speed with which millions of edits can be

applied, the detailed documentation

supporting the logic behind the rules, and the clear explanations for claim adjustments result in more automated claim

processing, faster turnaround, more consistent and understandable results, and improved customer service

As part of the

IntelliClaim package, IntelliClaim has incorporated two software packages to rebundle codes; these software packages are

the Correct Coding Initiative Software by The National Technical

each claim type. The NTIS software provides Oxford with the Correct Coding Rules used by

CMS. This software is the same software product used by fiscal intermediaries that process Medicare Fee for Service claims for CMS. The Correct Coding Rules can be found on CMS's website at www.cms.gov. The

CES software incorporates the quarterly updates that CMS makes to the Correct Coding rules into Oxford's claims processing system. CES contains rules consisting of, among other things, characterizes coding relationships on provider medical bills. CES provides information that allows claims

submitters, claims processors and adjudicators to identify potentially incorrect or inappropriate coding relationships by a single provider, for a single patient, on a single date of service. Examples of the rules include incidental, mutually exclusive, Unbundling and visit edits. Sources of the workbook rules include the AMA and CPT publications, CMS andspecialty societies.

Please note this Reimbursement policy is subject to Oxford's reimbursement

policies and rules. Refer to the Modifier Reference policy for additional information.

http://www.cms.gov/



Oxford


REVISED

Reimbursement for Comprehensive and Component CPT

Codes (CES) (continued)

Mar. 1, 2018

Information Service (NTIS) and effective October 6, 2006,

ClaimsXten™ by McKesson

o Added language to indicate:

Optum™ Claims Editing provides an extensive set of core rules that utilize historical data to

maximize auditing capabilities for claims

This system features flexible editing functions and complete customization

capabilities that allow Oxford to develop,

customize and update our payment guidelines as necessary

CES contains edits for both professional and

facility claims that are specific to each claim type

o Replaced references to: “IntelliClaim” and

“ClaimsXten” with “CES”

“KnowledgePacks” with

“rules/workbook rules” o Updated list of sources for

workbook rules; removed “McKesson physician consultants”





Oxford

Policy Title Effective Date Summary of Changes

RETIRED/REPLACED

Advanced Practice Provider Evaluation and Management

Procedures

Mar. 1, 2018 This policy is being retired, as it is currently under review. If the policy is reinstated in the future, it will follow our standard new policy notification guidelines.

Multiple Imaging

Rules

Apr. 1, 2018 This policy is being replaced; refer to the policy titled Multiple Procedure Payment Reduction (MPPR) for Diagnostic

Imaging for applicable reimbursement guidelines effective Apr. 1, 2018.

March 2018 policy update bulletin - OXHP2 Oxford® Policy Update Bulletin: March 2018 Oxford®...

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