august 2016 policy update bulletin - oxhp · igg/iga, or igm type of paraproteinemic polyneuropathy...

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

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

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

Oxford® Medical and Administrative Policy updates.*

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

August 2016

policy update bulletin Medical & Administrative Policy Updates

Oxford

Oxford

2 Oxford® Policy Update Bulletin: August 2016

Oxford® Medical and Administrative Policy Updates

Overview

Tips for using the Policy Update Bulletin:

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

directed to the corresponding policy update summary.

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

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

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review requirements

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

Updated

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

to the clinical coverage criteria or documentation review requirements;

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

list(s) of applicable codes may have been updated

Revised

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

the clinical coverage criteria and/or documentation review requirements

Replaced

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

Retired

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

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

necessary and are therefore not excluded as unproven/not medically

necessary services, unless coverage guidelines or criteria are otherwise

documented in another policy

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

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

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

applicable federal or state regulatory requirements. Additionally,

UnitedHealthcare reserves the right to review the clinical evidence

supporting the safety and effectiveness of a medical technology prior to

rendering a coverage determination.

This bulletin provides complete details on Oxford® Medical and

Administrative Policy updates. The appearance of a service or

procedure in this bulletin indicates only that Oxford® has recently

adopted a new policy and/or updated, revised, replaced or

retired an existing policy; it does not imply that Oxford® provides

coverage for the service or procedure. In the event of an

inconsistency or conflict between the information provided in this

bulletin and the posted policy, the provisions of the posted policy

will prevail. Note that most benefit plan documents exclude from

benefit coverage health services identified as investigational or

unproven/not medically necessary. Physicians and other health

care professionals may not seek or collect payment from a

member for services not covered by the applicable benefit plan

unless first obtaining the member’s written consent,

acknowledging that the service is not covered by the benefit plan

and that they will be billed directly for the service.

A complete library of Oxford® Medical and Administrative

Policies is available at OxfordHealth.com > Providers >

Tools & Resources > Medical Information > Medical and

Administrative Policies.


Clinical Policy Updates

Oxford

Clinical Policy Updates Page

UPDATED

Apheresis - Effective Aug. 1, 2016 ...................................................................................................................................................................... 6 Breast Reconstruction Post Mastectomy - Effective Sep. 1, 2016 .......................................................................................................................... 10 Bronchial Thermoplasty - Effective Aug. 1, 2016................................................................................................................................................. 12 Home Traction Therapy - Effective Aug. 1, 2016 ................................................................................................................................................. 12 Light and Laser Therapy for Cutaneous Lesions and Pilonidal Disease - Effective Sep. 1, 2016.................................................................................. 13 Meniscus Implant and Allograft - Effective Aug. 1, 2016 ...................................................................................................................................... 14 Molecular Profiling to Guide Cancer Treatment - Effective Aug. 1, 2016 ................................................................................................................. 15 Motorized Spinal Traction - Effective Aug. 1, 2016 .............................................................................................................................................. 17 Umbilical Cord Blood Harvesting and Storage for Future Use - Effective Aug. 1, 2016 .............................................................................................. 17

REVISED

17-Alpha-Hydroxyprogesterone Caproate (Makena™ and 17P) - Effective Sep. 1, 2016 ........................................................................................... 18 Cosmetic and Reconstructive Procedures - Effective Sep. 1, 2016 ......................................................................................................................... 19 Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Sep. 1, 2016 ................................................................................ 21 Drug Coverage Guidelines - Effective Sep. 1, 2016 ............................................................................................................................................. 21

o Actimmune (Interferon Gamma-1b) ............................................................................................................................................................ 21 o Afstyla (Antihemophilic Factor (Recombinant) Single Chain) ........................................................................................................................... 21 o Aptiom (Eslicarbazepine Acetate) ................................................................................................................................................................ 21 o Atralin (Tretinoin) ..................................................................................................................................................................................... 22 o Avita (Tretinoin) ....................................................................................................................................................................................... 22 o Bevespi Aerosphere (Glycopyrrolate/Formoterol Fumarate) ............................................................................................................................ 22 o Briviact (Brivaracetam) .............................................................................................................................................................................. 22 o Cabometyx (Cabozantinib) ......................................................................................................................................................................... 22 o Cetylev (Acetylcysteine) ............................................................................................................................................................................ 22 o Cometriq (Cabozantinib) ............................................................................................................................................................................ 22 o Depakote (Divalproex Sodium) ................................................................................................................................................................... 22 o Depakote ER (Divalproex Sodium Extended Release) ..................................................................................................................................... 22 o Differin (Adapalene) .................................................................................................................................................................................. 22 o Epclusa (Sofosbuvir/Velpatasfir) ................................................................................................................................................................. 23 o Fabior (Tazarotene) ................................................................................................................................................................................... 23 o Felbatol (Felbamate) ................................................................................................................................................................................. 23 o Fycompa (Perampanel) .............................................................................................................................................................................. 23 o Genotropin (Somatropin) ........................................................................................................................................................................... 23 o Gialax Kit (Polyethylene Glycol) .................................................................................................................................................................. 23 o Gilotrif (Afatinib) ....................................................................................................................................................................................... 23 o Humatrope (Somatropin) ........................................................................................................................................................................... 23



Oxford

o Impavido (Miltefosine) ............................................................................................................................................................................... 23 o Jentadueto XR (Linagliptin/Metformin) ......................................................................................................................................................... 23 o Keppra (Levetiracetam) ............................................................................................................................................................................. 24 o Keppra XR (Levetiracetam Extended Release[XR]) ........................................................................................................................................ 24 o Lamictal (Lamotrigine) ............................................................................................................................................................................... 24 o Lamictal ODT (Lamotrigine Orally Disintegrating Tablets) ............................................................................................................................... 24 o Lamictal XR (Lamotrigine Extended Release) ................................................................................................................................................ 24 o Lamotrigine XR ......................................................................................................................................................................................... 24 o Multaq (Dronedarone) ............................................................................................................................................................................... 24 o Myalept (Metreleptin) ................................................................................................................................................................................ 24 o Mysoline (Primidone) ................................................................................................................................................................................. 24 o Neurontin (Gabapentin) ............................................................................................................................................................................. 24 o Norditropin AQ (Somatropin) ...................................................................................................................................................................... 24 o Norditropin (Somatropin) ........................................................................................................................................................................... 24 o Norditropin Nordiflex (Somatropin).............................................................................................................................................................. 24 o Nuspin (Somatropin) ................................................................................................................................................................................. 25 o Nutropin and Nutropin AQ (Somatropin) ...................................................................................................................................................... 25 o Omnitrope (Somatropin) ............................................................................................................................................................................ 25 o Oxtellar XR (Oxcarbazepine Extended Release) ............................................................................................................................................. 25 o Procysbi (Cysteamine Bitartrate) ................................................................................................................................................................. 25 o Qudexy XR (Topiramate)............................................................................................................................................................................ 25 o Retin-A (Tretinoin) .................................................................................................................................................................................... 25 o Retin-A Micro (Tretinoin) ............................................................................................................................................................................ 25 o Retin-A Micro Pump (Tretinoin) (Brand and Generic) ..................................................................................................................................... 25 o Saizen (Somatropin) ................................................................................................................................................................................. 25 o Serostim (Somatropin) .............................................................................................................................................................................. 25 o Sirturo (Bedaquiline) ................................................................................................................................................................................. 25 o Spritam (Levetiracetam) ............................................................................................................................................................................ 26 o Stavzor (Valproic Acid) .............................................................................................................................................................................. 26 o Stivarga (Regorafenib) .............................................................................................................................................................................. 26 o Sutent (Sunitinib) ..................................................................................................................................................................................... 26 o Syprine (Trientine Hydrochloride)................................................................................................................................................................ 26 o Tazorac (Taxarotene) ................................................................................................................................................................................ 26 o Topamax (Topiramate) .............................................................................................................................................................................. 26 o Tretin-X 0.075% Cream (Tretinoin) ............................................................................................................................................................. 26 o Tretin-X 0.0375% Cream (Tretinoin) ........................................................................................................................................................... 26 o Tretin-X Kit (Tretinoin) .............................................................................................................................................................................. 26 o Trileptal (Oxcarbazepine) ........................................................................................................................................................................... 26 o Trokendi XR (Topiramate) .......................................................................................................................................................................... 26 o Uptravi (Selexipag) ................................................................................................................................................................................... 26 o Veltassa (Patiromer) .................................................................................................................................................................................. 26 o Vimpat (Lacosamide): Tablet ...................................................................................................................................................................... 27



Oxford

o Vonvendi (Von Willebrand Factor, Recombinant) ........................................................................................................................................... 27 o Vraylar (Cariprazine) ................................................................................................................................................................................. 27 o Xuriden (Uridine Triacetate) ....................................................................................................................................................................... 27 o Zomacton (Somatropin) ............................................................................................................................................................................. 27 o Zonegran (Zonisamide) ............................................................................................................................................................................. 27 o Zorbtive (Somatropin) ............................................................................................................................................................................... 27

Obstructive Sleep Apnea Treatment - Effective Oct. 1, 2016 ................................................................................................................................ 27 Pectus Deformity Repair - Effective Sep. 1, 2016 ................................................................................................................................................ 30 Preventive Care Services - Effective Oct. 1, 2016 ............................................................................................................................................... 31 Private Duty Nursing Services (PDN) - Effective Sep. 1, 2016 ............................................................................................................................... 36 Rhinoplasty and Other Nasal Surgeries - Effective Sep. 1, 2016............................................................................................................................ 39 Site of Service Guidelines for Certain Outpatient Surgical Procedures - Effective Oct. 1, 2016 .................................................................................. 49 Total Knee Replacement Surgery (Arthroplasty) - Effective Sep. 1, 2016 ............................................................................................................... 52 Transcatheter Heart Valve Procedures - Effective Sep. 1, 2016 ............................................................................................................................. 52

Administrative Policy Updates

REVISED

Behavioral Health Services - Effective Aug. 1, 2016 ............................................................................................................................................ 55

Reimbursement Policy Updates

UPDATED

B Bundle Codes - Effective Aug. 1, 2016 ............................................................................................................................................................ 56 Injection and Infusion Services - Effective Aug. 8, 2016 ...................................................................................................................................... 56 Maximum Frequency Per Day - Effective Aug. 8, 2016 ......................................................................................................................................... 58 Multiple Procedures - Effective Aug. 8, 2016 ...................................................................................................................................................... 63 Pediatric and Neonatal Critical and Intensive Care Services - Effective Aug. 8, 2016 ............................................................................................... 68 Preventive Medicine and Screening - Effective Aug. 8, 2016 ................................................................................................................................. 72 Procedure and Place of Service - Effective Aug. 8, 2016 ...................................................................................................................................... 74 Time Span Codes - Effective Aug. 8, 2016 ......................................................................................................................................................... 74 Urgent Care - Effective Aug. 1, 2016 ....................................................................................................................... Error! Bookmark not defined.

REVISED

Durable Medical Equipment, Orthotics and Prosthetics Multiple Frequency - Effective Sep. 1, 2016 ........................................................................... 77 Global Days - Effective Sep. 1, 2016 ................................................................................................................................................................. 81 Pediatric and Neonatal Critical and Intensive Care Services - Effective Sep. 1, 2016 ............................................................................................... 87 T Status Codes - Effective Sep. 1, 2016............................................................................................................................................................. 88



Oxford

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Apheresis

Aug. 1, 2016

Reformatted and reorganized policy; transferred content to new template

Updated/clarified coverage

rationale: o Replaced language indicating

“therapeutic apheresis is proven and medically necessary for the listed diagnoses” with “therapeutic apheresis is proven and

medically necessary for treating or managing the listed conditions/diagnoses”

o Replaced language indicating “therapeutic apheresis including plasma exchange,

plasmapheresis, or

photopheresis is unproven and not medically necessary for the listed indications” with “therapeutic apheresis including plasma exchange, plasmapheresis, or

photopheresis is unproven and not medically necessary for treating or managing the conditions/diagnoses, including but not limited to,

those listed” o Replaced language indicating

“apheresis is first-line therapy for the listed conditions” with “apheresis is first-line therapy when treating or managing the listed conditions/diagnoses”

o Replaced language indicating

“apheresis is proven and

Therapeutic apheresis is proven and medically necessary for treating or managing the following conditions/diagnoses: ABO incompatible heart transplantation in children less than 40 months

of age (plasma exchange)

ABO incompatible hematopoietic stem cell and bone marrow transplant (plasma exchange)

ABO incompatible kidney transplantation (plasma exchange) Acute inflammatory demyelinating polyneuropathy (Guillain-Barré

syndrome) (plasma exchange) ANCA-associated rapidly progressive glomerulonephritis (Wegener's

Granulomatosis) (plasma exchange)

Anti-glomerular basement membrane disease (Goodpasture's syndrome) (plasma exchange)

Babesiosis (RBC exchange) Cardiac allograft rejection or prophylaxis of cardiac transplant rejection

(photopheresis) Chronic inflammatory demyelinating polyneuropathy (plasma exchange)

Cryoglobulinemia (plasma exchange)

Cutaneous T-cell lymphoma; mycosis fungoides; Sézary syndrome, erythrodermic (photopheresis)

Heterozygous or homozygous familial hypercholesterolemia (plasma exchange or selective adsorption)

Focal segmental glomerulosclerosis, recurrent (plasma exchange) Graft-versus-host disease, skin, chronic (photopheresis)

Hyperleukocytosis, leukostasis (leukocytapheresis) IgG/IgA, or IgM type of paraproteinemic polyneuropathy (plasma

exchange) Hyperviscosity in monoclonal gammopathies, treatment of symptoms

(plasma exchange)

Lung allograft rejection (photopheresis) Multiple sclerosis (relapsing form with steroid resistant exacerbations)

(plasma exchange) Myasthenia gravis (plasma exchange) Neuromyelitis optica (Devic's syndrome) (plasma exchange) Renal transplantation, antibody mediated rejection (plasma exchange) Renal transplantation, desensitization, living or deceased donor

recipients, positive crossmatch due to donor specific HLA antibody (plasma exchange) Rheumatoid arthritis, refractory (immunoadsorption)

Sickle cell disease for one of the following:



Oxford

UPDATED


Apheresis (continued)

Aug. 1, 2016

medically necessary for persons who are refractory to or intolerant of standard therapy for the listed conditions where apheresis is

second-line therapy” with

“apheresis is proven and medically necessary for persons who are refractory to or intolerant of standard therapy for the listed conditions/diagnoses where

apheresis is second-line therapy”

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

o Red blood cell exchange for treating acute stroke, acute chest syndrome, or multiorgan failure

o Prophylaxis with red blood cell exchange for primary or secondary stroke prevention or for prevention of transfusional iron overload

Thrombotic thrombocytopenic purpura (plasma exchange)

Therapeutic apheresis including plasma exchange, plasmapheresis, or photopheresis is unproven and not medically necessary for treating or managing the following conditions/diagnoses, including but not limited to: ABO incompatible solid organ transplantation, liver perioperative Acute disseminated encephalomyelitis

Acute liver failure Age related macular degeneration Amyloidosis, systemic Amyotrophic lateral sclerosis Aplastic anemia; pure red cell aplasia Autoimmune hemolytic anemia: warm autoimmune hemolytic anemia;

cold agglutinin disease

Burn shock resuscitation Catastrophic antiphospholipid syndrome Chronic focal encephalitis (Rasmussen's encephalitis) Coagulation factor inhibitors Cutaneous T-cell lymphoma; mycosis fungoides; Sézary syndrome, non-

erythrodermic

Dermatomyositis or polymyositis Dilated cardiomyopathy Graft-versus-host disease, skin, acute Graft-versus-host disease, non-skin, acute/chronic

Hereditary hemochromatosis Hemolytic uremic syndrome High density lipoprotein (HDL) delipidation and plasma reinfusion

Hyperleukocytosis, prophylaxis Hypertriglyceridemic pancreatitis Hyperviscosity in monoclonal gammopathies, prophylaxis for rituximab IgG/IgA or IgM type of paraproteinemic polyneuropathy treated with

immunoadsorption Immune thrombocytopenic purpura Immune complex rapidly progressive glomerulonephritis



Oxford

UPDATED



Aug. 1, 2016

Inclusion body myositis Inflammatory bowel disease Lambert-Eaton myasthenic syndrome Malaria Multiple myeloma type of paraproteinemic polyneuropathy

Multiple sclerosis, chronic progressive or secondary progressive

Myeloma cast nephropathy Nephrogenic systemic fibrosis Overdose, venoms, and poisoning Paraneoplastic neurologic syndromes Pediatric autoimmune neuropsychiatric disorders associated with

streptococcal infections (PANDAS) and Sydenham’s chorea

Pemphigus vulgaris Phytanic acid storage disease (Refsum's disease) Polycythemia vera and erythrocytosis POEMS (polyneuropathy, organomegaly, endocrinopathy, M protein, and

skin changes) Post transfusion purpura

Psoriasis

Red cell alloimmunization in pregnancy Rheumatoid arthritis, refractory, treated with plasma exchange Schizophrenia Scleroderma (progressive systemic sclerosis) Sepsis with multiorgan failure Stiff-person syndrome

Systemic lupus erythematosus Thrombocytosis Thrombotic microangiopathy: drug-associated Thrombotic microangiopathy: hematopoietic stem cell transplant-

associated Thyroid storm Wilson's disease, fulminant

There is insufficient evidence to conclude that apheresis, plasma exchange, plasmapheresis, immunoadsorption, or photopheresis is beneficial for health outcomes such as decreased morbidity and mortality rates in patients with disorders other than those listed as medically necessary. Apheresis is first-line therapy when treating or managing the



Oxford

UPDATED



Aug. 1, 2016

following conditions/diagnoses: Acute inflammatory demyelinating polyneuropathy (Guillain-Barré

syndrome) (plasma exchange) ANCA-associated rapidly progressive glomerulonephritis (Wegener’s

Granulomatosis) (plasma exchange)

Anti-glomerular basement membrane disease (Goodpasture’s syndrome)

(plasma exchange) Babesiosis (RBC exchange) Cardiac allograft rejection prophylaxis (photopheresis) Chronic inflammatory demyelinating polyneuropathy (plasma exchange) Cryoglobulinemia (plasma exchange) Cutaneous T-cell lymphoma; mycosis fungoides; Se´zary syndrome,

erythrodermic (photopheresis) Homozygous familial hypercholesterolemia (plasma exchange or selective

adsorption) Hyperleukocytosis, leukostasis (leukocytapheresis) Hyperviscosity in monoclonal gammopathies, treatment of symptoms

(plasma exchange)

IgG/IgA, or IgM type of paraproteinemic polyneuropathy (plasma

exchange) Myasthenia gravis (plasma exchange) Renal transplantation, antibody mediated rejection (plasma exchange) Renal transplantation, desensitization, living or deceased donor

recipients, positive crossmatch due to donor specific HLA antibody (plasma exchange)

Sickle cell disease for one of the following: o Red blood cell exchange for treating acute stroke or multiorgan

failure o Prophylaxis with red blood cell exchange for primary or secondary

stroke prevention or for prevention of transfusional iron overload Thrombotic thrombocytopenic purpura (plasma exchange)

Apheresis is proven and medically necessary for persons who are refractory to or intolerant of standard therapy for the following conditions/diagnoses where apheresis is second-line therapy: ABO incompatible heart transplantation in children less than 40 months

of age (plasma exchange) ABO incompatible hematopoietic stem cell and bone marrow transplant

(plasma exchange)



Oxford

UPDATED



Aug. 1, 2016

ABO incompatible kidney transplantation (plasma exchange) Cardiac allograft rejection (photopheresis) Focal segmental glomerulosclerosis, recurrent (plasma exchange) Heterozygous familial hypercholesterolemia (plasma exchange or

selective adsorption)

Graft-versus-host disease, skin, chronic (photopheresis)

Lung allograft rejection (photopheresis) Multiple sclerosis (relapsing form with steroid resistant exacerbations)

(plasma exchange) Neuromyelitis optica (Devic’s syndrome) (plasma exchange) Rheumatoid arthritis, refractory (immunoadsorption) Sickle cell disease, acute chest syndrome (red blood cell exchange)

Breast Reconstruction Post Mastectomy

Sep. 1, 2016


Updated list of applicable CPT codes for breast reconstruction

post mastectomy; added S2066, S2067 and S2068

Indications for Coverage

Breast reconstruction is covered for Members who have a mastectomy with or without a diagnosis of cancer. Mastectomy includes partial (lumpectomy, tylectomy, quadrantectomy, and segmentectomy), simple, and radical. This benefit does not include aspirations, biopsy (open or

core), excision of cysts, fibroadenomas or other benign or malignant tumors, aberrant breast tissue, duct lesions, nipple or areolar lesions, or treatment of gynecomastia.

There is not a time frame in which the Member is required to have the reconstruction done post mastectomy under the Women’s Health and Cancer Rights Act of 1998.

In accordance with Federal and State mandates, the following services are covered:

Reconstruction of the breast on which the mastectomy was performed Surgery and reconstruction of the other breast to produce a symmetrical

appearance, including nipple tattooing Prosthesis (Implanted and/or external) Treatment of physical complications of mastectomy, including

lymphedema

Various surgical techniques are used for breast reconstruction, including but not limited to: Insertion of FDA approved breast implants and tissue expanders Breast Implants and tissue expanders post mastectomy with or without



Oxford

UPDATED


Breast Reconstruction Post Mastectomy (continued)

Sep. 1, 2016

skin substitutes, approved by the FDA, including but not limited to: Alloderm, Allomax or FlexHD are a covered benefit

Transverse Rectus Abdominus Myocutaneous Flap (TRAM) Latissimus Dorsi Flap (LD) Deep Inferior Epigastric Perforator (DIEP) Flap

Gluteal Flap (GAP free flap)

If the original implant or reconstructive surgery was considered reconstructive surgery by Oxford, coverage may exist for removal, replacement and/or reconstruction. If the original implant or reconstructive surgery was considered reconstructive surgery under the Oxford benefit document, then removal of a ruptured prosthesis is treating a "complication

arising from a medical or surgical intervention." Removal or replacement of an implant that is not ruptured and unassociated with local breast complications may not be covered. Additional Information

An in-network exception may be granted if there is not an in-network provider able to provide the requested reconstructive procedure. Refer to the member specific benefit plan document and the In-Network Exceptions for Breast Reconstruction Surgery Following Mastectomy policy for information

regarding coverage from non-network providers. Breast reconstruction may be covered under certain circumstances for the surgical treatment of gender dysphoria. Please refer to the member specific benefit plan document for coverage determination. Treatments for Complications Post Mastectomy

Lymphedema:

o Complex Decongestive Physiotherapy (CDP) is covered for the

complication of lymphedema post mastectomy o Lymphedema pumps when required are covered o Compression Lymphedema sleeves are covered o Elastic bandages and wraps associated with covered treatments for

the complications of lymphedema Treatment of a post-operative infection(s).

Removal of a ruptured breast implant (either silicone or saline) is reconstructive for implants done post mastectomy. Placement of a new breast implant will be covered if the original implantation was done post



Oxford

UPDATED


Breast Reconstruction Post Mastectomy (continued)

Sep. 1, 2016

mastectomy or for a covered reconstructive health service. Coverage Limitations and Exclusions

Please refer to the member specific benefit plan document and any federal or state mandates, if applicable.

Insertion of breast implants or reinsertion of breast implants for the purpose of improving appearance is a cosmetic procedure unless covered

under a state or federal mandate. o If the breast reconstruction has been successfully completed post

mastectomy and the member chooses to enlarge their breasts for cosmetic reasons, this is considered a cosmetic service and is not covered.

Breast reconstruction or scar revision after breast biopsy or removal of a cyst with or without a biopsy usually does not meet the definition of a

covered reconstructive health service. Refer to the member specific benefit plan documents and state mandates.

Tissue protruding at the end of a scar (“dog ear”/standing cone), painful

scars or donor site scar revisions must be reviewed to determine if the procedure meets reconstructive guidelines.

Liposuction other than to achieve breast symmetry during post mastectomy reconstruction is considered cosmetic and is not covered.

Revision of prior reconstructed breast due to normal aging does not meet the definition of a covered reconstructive health service.

Not medically necessary services.

Bronchial Thermoplasty

Aug. 1, 2016 Reformatted and reorganized policy; transferred content to

new template Updated supporting information

to reflect the most current

description of services, clinical evidence, FDA information and references

Bronchial thermoplasty is unproven and not medically necessary for treating asthma.

There is insufficient and low quality evidence regarding the use of bronchial thermoplasty in patients with severe asthma, who are resistant to standard therapies. Additional well-designed studies are needed to identify the long-

term safety and efficacy of bronchial thermoplasty for the treatment of severe asthma.

Home Traction Therapy

Aug. 1, 2016


Updated list of applicable HCPCS codes: o Modified table heading;

Home traction therapy is unproven and not medically necessary for treating low back and neck disorders with or without radiculopathy. The majority of studies are office based with mixed results. The quality of peer reviewed studies for home traction are limited as well to conclude that it is effective in the management of neck or low back pain or that it improves health outcomes. The indications for clinical application, patient selection



Oxford

UPDATED


Home Traction Therapy (continued)

Aug. 1, 2016 removed descriptor classifying codes as “non-reimbursable”

Updated supporting information to reflect the most current

clinical evidence and references

criteria, risks, and comparison to alternative technologies have not been established for home traction therapy.

Light and Laser Therapy for Cutaneous Lesions and Pilonidal Disease

Sep. 1, 2016 Reformatted and reorganized policy; transferred content to new template

Updated list of applicable ICD-9 diagnosis codes (discontinued

Oct. 1, 2015); removed 685.0, 685.1, 695.3, and 706.1

Updated list of applicable ICD-10 diagnosis codes: o Modified table headings;

removed descriptor

classifying codes as “proven” or “unproven”

o Removed L05.01, L05.02, L05.91, L05.92, L71.0, L71.1, L71.8, L71.9, L70.0, L70.1, L70.3, L70.4, L70.5, L70.8, L70.9, and L73.0

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

Port-Wine Stains and Cutaneous Hemangiomata

Pulsed dye laser therapy is proven and medically necessary for treating port-wine stains and cutaneous hemangiomata. Rosacea and Rhinophyma

Light and laser therapy including intense pulsed light are unproven and not medically necessary for treating rosacea and rhinophyma. The quantity and quality of the evidence is insufficient to recommend light and laser treatment for the treatment of rosacea and rhinophyma. The

quality of evidence is limited. Additional research is needed to determine efficacy and safety and to clarify patient selection and treatment parameters.

Acne Vulgaris

Light and laser therapy including light phototherapy, photodynamic therapy, intense pulsed light, and pulsed dye laser are unproven and not medically necessary for treating active acne vulgaris. There is insufficient evidence to recommend the use of light and laser therapy for the treatment acne vulgaris. Studies evaluating light and laser

therapy for acne typically are short term, lack controls or the patient serves as their own control, have small sample sizes, and do not compare laser therapy with standard acne treatment. Well-designed studies are necessary to clarify the role of light and laser therapy for acne.

Pilonidal Sinus Disease

Laser hair removal is unproven and not medically necessary for treating pilonidal sinus disease. There is insufficient evidence to conclude that laser hair removal is effective

for treating pilonidal sinus disease. Most of the studies regarding this treatment were small and uncontrolled. Additional well designed controlled trials are needed to determine the efficacy of laser hair removal for pilonidal disease.



Oxford

UPDATED


Meniscus Implant and Allograft

Aug. 1, 2016


Added reference links to related policies titled:

o Osteochondral Grafting of

the Knee o Unicondylar Spacer Devices

for Treatment of Pain or Disability

o Autologous Chondrocyte Transplantation In The Knee

Updated/clarified coverage rationale: o Replaced language indicating

“meniscus allograft transplantation with human cadaver tissue is proven and

medically necessary for

replacement of major meniscus loss due to trauma or previous meniscectomy when all of the listed indications are present” with “meniscus allograft

transplantation with human cadaver tissue is proven and medically necessary for replacement of major

meniscus loss due to trauma or previous meniscectomy when all of the listed criteria

are met” o Replaced language indicating

“collagen meniscus implants are unproven and not medically necessary for the treatment of meniscus injuries or tears” with

Meniscus allograft transplantation with human cadaver tissue is proven and medically necessary for replacement of major meniscus loss due to trauma or previous meniscectomy when ALL of the following criteria are met: Patient who is skeletally mature with documented closure of growth

plates

Patient has significant knee pain and limited function Patient is missing more than half of the meniscus due to surgery or injury

or has a tear that cannot be repaired Radiographic criteria established by a standing anteroposterior (AP) view

demonstrates all of the following: o Normal alignment or correctable varus or valgus deformities

o No osteophytes or marginal osteophytes o No irreparable articular cartilage defects o No significant joint space narrowing

Ligamentous stability has been achieved prior to surgery or achieved concurrently with meniscal transplantation (e.g., concomitant anterior cruciate ligament surgery)

Documented minimal to absent degenerative changes in surrounding

articular cartilage (Outerbridge Grade II or less) There is no evidence of active inflammatory arthritis or systemic arthritis Patient who has failed conservative treatment including physical therapy

and/or bracing techniques. Collagen meniscus implants are unproven and not medically

necessary for treating or evaluating and managing meniscus injuries or tears. There is insufficient evidence that collagen meniscus implants improve health outcomes such as reduction of symptoms and restoration of knee function in

patients with meniscus injuries or tears. Additional studies with long term follow-up are needed to determine whether implantation of a collagen scaffold is able to slow joint degeneration, delay the progression of

osteoarthritis, and reduce pain for long durations.



Oxford

UPDATED


Meniscus Implant and Allograft (continued)

Aug. 1, 2016 “collagen meniscus implants are unproven and not medically necessary for treating or evaluating and managing meniscus injuries

or tears”


removed descriptor classifying codes as “non-reimbursable”

Updated supporting information to reflect the most current description of services, FDA information and references

Molecular Profiling

to Guide Cancer Treatment

Aug. 1, 2016

Reformatted and reorganized

policy; transferred content to new template

Updated/clarified coverage rationale: o Replaced language indicating

“molecular profiling using multiplex or next generation

sequencing (NGS) technology is proven and medically necessary to guide systemic chemotherapy in patients with metastatic

stage IV non-small cell lung cancer (NSCLC) when used

to test only for epidermal growth factor receptor (EGFR) mutations, human epidermal growth factor receptor 2 (HER2) mutations, RET

rearrangements, and anaplastic lymphoma kinase

Molecular profiling using multiplex or next generation sequencing

(NGS) technology is proven and medically necessary for guiding systemic chemotherapy in patients with metastatic stage IV non-small cell lung cancer (NSCLC) when both of the following criteria are met: Molecular profiling using multiplex or NGS technology to test for

epidermal growth factor receptor (EGFR) mutations, human epidermal growth factor receptor 2 (HER2) mutations, RET

rearrangements, and anaplastic lymphoma kinase (ALK) gene arrangements

See the National Comprehensive Cancer Network (NCCN) Clinical Practice

Guideline for Non-Small Cell Lung Cancer, available at www.nccn.org, for updates regarding oncogenes used in molecular profile testing for NSCLC.

(Accessed April 21, 2016) The laboratory providing molecular profiling testing services must

be approved by the New York State Department of Health for performing the molecular profile test.

See the following web site for a list of clinical laboratories holding a New York State Department of Health permit in the category of oncology

molecular and cellular tumor markers: http://www.wadsworth.org/labcert/clep/CategoryPermitLinks/CategoryListing.htm (Accessed April 21, 2016)

http://www.nccn.org/http://www.wadsworth.org/labcert/clep/CategoryPermitLinks/CategoryListing.htmhttp://www.wadsworth.org/labcert/clep/CategoryPermitLinks/CategoryListing.htm



Oxford

UPDATED


Molecular Profiling to Guide Cancer Treatment (continued)

Aug. 1, 2016

(ALK) gene arrangements” with “molecular profiling using multiplex or next generation sequencing (NGS) technology is proven

and medically necessary for

guiding systemic chemotherapy in patients with metastatic stage IV non-small cell lung cancer (NSCLC) when used to test for epidermal growth factor

receptor (EGFR) mutations, human epidermal growth factor receptor 2 (HER2) mutations, RET rearrangements, and anaplastic lymphoma kinase

(ALK) gene arrangements”

o Replaced language indicating “molecular profiling using multiplex or NGS technology is unproven and not medically necessary when the listed criteria are not

met” with “molecular profiling using multiplex or NGS technology is unproven and not medically necessary

for all other indications [not listed as proven/medically necessary]”

Updated definitions: o Revised definition of “genetic

testing” o Removed definition of

“molecular profiling” Updated supporting information

to reflect the most current

Molecular profiling using multiplex or NGS technology is unproven and not medically necessary for all other indications. There is insufficient evidence in the clinical literature demonstrating that molecular profiling has a role in clinical decision-making or has a beneficial effect on health outcomes for other indications. Further studies are needed to

determine the analytic validity, clinical validity and/or clinical utility of

molecular profiling using multiplex or NGS technology for other indications.



Oxford

UPDATED


Molecular Profiling to Guide Cancer Treatment (continued)

Aug. 1, 2016 clinical evidence and references

Motorized Spinal

Traction

Aug. 1, 2016 Reformatted and reorganized

policy; transferred content to new template

Updated/clarified coverage rationale; modified language pertaining to clinical evidence/study findings on

effectiveness of spinal unloading devices for the management of neck or low back pain to clarify the indications for use, patient selection criteria, risks, and comparison to alternative

technologies have not been established by the U.S. Food and Drug Administration (FDA) for motorized traction therapy


removed descriptor classifying codes as “non-reimbursable”


description of services, clinical evidence and references

Motorized spinal traction devices are unproven and not medically

necessary for treating neck and low back disorders. There is insufficient evidence from peer-reviewed published studies to conclude that spinal unloading devices are effective in the management of neck or low back pain or that they improve health outcomes. The indications for use, patient selection criteria, risks, and comparison to alternative technologies have not been established by the U.S. Food and Drug

Administration (FDA) for motorized traction therapy. (Accessed March 30, 2016)

Umbilical Cord Blood Harvesting and Storage for Future Use

Aug. 1, 2016


Updated/clarified non-coverage rationale:

o Rephrased coverage statement to indicate

Collection and storage of umbilical cord blood for possible later use is unproven and not medically necessary for a person currently healthy but desiring to provide the opportunity for a hypothetical, future transplantation. Published clinical evidence on the use of umbilical cord blood is limited to

diagnosis-specific indications for persons who would otherwise be eligible for human leukocyte antigen (HLA)-compatible allogeneic bone marrow or stem



Oxford

UPDATED


Umbilical Cord Blood Harvesting and Storage for Future Use (continued)

Aug. 1, 2016 collection and storage of umbilical cord blood for possible later use is unproven and not medically necessary for a person

currently healthy but

desiring to provide the opportunity for a hypothetical, future transplantation

o Added reference link to the Clinical Guideline titled

Transplant Review Guidelines for additional information on umbilical cord blood stem cell transplantation


clinical evidence and references

cell transplants. Current available clinical evidence does not support the hypothesis that storage for hypothetical future use improves health outcomes. For additional information and coverage of umbilical cord blood stem cell

transplantation, please refer to the UnitedHealth Group Transplant Review

Guidelines.

REVISED


17-Alpha-Hydroxyprogest-erone Caproate (Makena™ and

17P)

Sep. 1, 2016

Added reference link to policy titled Preterm Labor: Identification and Treatment

Revised coverage rationale:

o Updated proven/medically necessary criteria; added language to clarify

administration of intramuscular injection of 17P for prevention of

spontaneous preterm birth is to continue weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first

o Replaced language indicating

17-alpha-hydroxyprogesterone caproate, commonly called 17P, may also be referred to as 17-OHP, 17-OHPC, 17Pc, Makena™, 17-alpha hydroxyprogesterone, hydroxyprogesterone, hydroxy-progesterone, and hydroxy progesterone. Hereafter, it will be referred to as 17P.

Note: Oral and intravaginal formulations of progesterone are not addressed in this policy.

Intramuscular injection of 17P is proven and medically necessary for the prevention of spontaneous preterm birth when ALL of the

following criteria are met: Current singleton pregnancy; and History of a prior spontaneous preterm birth of a singleton pregnancy;

and Treatment is initiated between 16 weeks, 0 days of gestation and 26

weeks, 6 days of gestation; and Administration is to continue weekly until week 37 (through 36 weeks, 6



Oxford

REVISED


17-Alpha-Hydroxyprogest-erone Caproate (Makena™ and 17P)

(continued)

Sep. 1, 2016 “intramuscular injection of 17P is unproven and not medically necessary for prevention of spontaneous preterm birth in women with

any of the listed criteria”

with “intramuscular injection of 17P is unproven and not medically necessary for prevention of spontaneous preterm birth with any of the listed criteria”

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

days) of gestation or delivery, whichever occurs first. Intramuscular injection of 17P is unproven and not medically necessary for: Prevention of spontaneous preterm birth with any of the following:

o Short cervix with or without cerclage and no prior preterm birth;

o Current multi-fetal pregnancy (twins or greater); o Previous medically indicated preterm birth

Initiation of 17P after 26 weeks, 6 days of gestation

Although there are ongoing clinical trials to broaden the indications for the use of 17P, at this time uses as indicated above are considered unproven and

not medically necessary. *Additional Information Regarding Compounded 17P: The active ingredient in the compounded 17P and Makena is hydroxyprogesterone caproate. Both have castor oil as an inactive ingredient. The compounded version can be made with an alternate oil base in the event of patient

hypersensitivity to castor oil. Makena has the additional inactive ingredients

of benzyl benzoate and benzyl alcohol (a preservative). Based on the active ingredient, compounded preservative-free 17P is considered clinically interchangeable with Makena. Compounding pharmacies must comply with United States Pharmacopeia (USP) Chapter 797, which sets standards for the compounding,

transportation, and storage of compounded sterile products (CSP).1 The Pharmacy Compounding Accreditation Board will verify that the pharmacy is adhering to these standards.

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

additional information.

Cosmetic and Reconstructive Procedures

Sep. 1, 2016


Revised coverage

rationale/criteria for a procedure to be considered reconstructive

Indications for Coverage

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. Refer to the member specific benefit plan document.



Oxford

REVISED


Cosmetic and Reconstructive Procedures (continued)

Sep. 1, 2016

and medically necessary; added language to indicate: o Microtia repair is

reconstructive; although no functional impairment may

be documented for microtia,

this has been deemed reconstructive surgery

Updated definitions: o Added definition of

“microtia” o Removed definitions of:

Abdominoplasty Blepharoplasty Brow Ptosis Breast reduction

mammoplasty Cleft lip & palate

Mastectomy

Panniculectomy Panniculus Visual field

Updated list of applicable procedure codes: o Removed CPT code 30120

(refer to the policy titled Rhinoplasty and Other Nasal Surgeries for applicable coverage guidelines)

o Removed HCPCS codes S2066, S2067, and S2068 (refer to the policy titled

Breast Reconstruction Post Mastectomy for applicable coverage guidelines)

o Updated coding clarification language for flaps (skin and/or deep tissue) procedures (CPT codes

Criteria for a Procedure to be Considered Reconstructive and Medically Necessary

There is documentation that the physical abnormality and/or physiological abnormality is causing a functional impairment (as defined in the Definitions section of the policy) that requires correction.

The proposed treatment is of proven efficacy; and is deemed likely to significantly improve or restore the patient’s physiological function.

Microtia repair is reconstructive. Although no functional impairment may be documented for Microtia, this has been deemed reconstructive surgery.

Coverage Limitations and Exclusions

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 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.



Oxford

REVISED


Cosmetic and Reconstructive Procedures (continued)

Sep. 1, 2016 15570-15738); removed language indicating the regions listed refer to a donor site when a tube is formed for later transfer or

when a "delay" of flap occurs

prior to the transfer

Drug Coverage Criteria - New and Therapeutic Equivalent

Medications

Sep. 1, 2016 Revised list of medications requiring precertification through the pharmacy benefit manager (PBM):

o Added Afstyla, Bevespi Aerosphere, Cetylev, Epclusa, Gialax Kit, Jentadueto XR, and Vonvendi

o Removed Uptravi and

Vraylar Updated formulary alternatives

for Ativan (brand only), Lipitor (brand only), Myrbetriq, Nuvigil, Vesicare, Xanax (brand only) and Xanax XR (brand only)

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

REVISED

Policy Title Effective Date Drug/Medication Status Summary of Changes

Drug Coverage Guidelines

Sep. 1, 2016 Actimmune (Interferon Gamma-1b)

Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Actimmune (interferon gamma-1b)

for complete details

Afstyla (Antihemophilic

Factor (Recombinant) Single Chain)

New Added coverage criteria/precertification requirements:

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

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

Aptiom (Eslicarbazepine

Acetate)

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

Authorization/Medical Necessity Guidelines: Aptiom (eslicarbazepine acetate) for complete details



Oxford

REVISED


Drug Coverage Guidelines (continued)

Sep. 1, 2016 Atralin (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Atralin (tretinoin) for complete details

Avita (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Avita (tretinoin) for complete details

Bevespi Aerosphere (Glycopyrrolate/Formoterol Fumarate)

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

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

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

Briviact (Brivaracetam) Revised Revised coverage criteria/precertification requirements; added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Briviact for complete details

Cabometyx (Cabozantinib)


Pharmacy Benefit Manager (PBM) o Added prior authorization/notification guidelines; refer to Prior

Authorization/Notification Guidelines: Cabometyx for complete details

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


Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic

Equivalent Medications for complete details

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

Depakote (Divalproex Sodium)

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

details

Depakote ER (Divalproex Sodium Extended Release)

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

Differin (Adapalene) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Differin (adapalene) for complete details



Oxford

REVISED



Sep. 1, 2016 Epclusa (Sofosbuvir/Velpatasfir)

Revised Revised coverage criteria/precertification requirements; added therapeutic equivalent guidelines; refer to Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details

Fabior (Tazarotene) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Fabior (tazarotene) for complete

details

Felbatol (Felbamate) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Felbatol for complete details

Fycompa (Perampanel) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Fycompa for complete details

Genotropin (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Genotropin (somatropin) for

complete details

Gialax Kit (Polyethylene Glycol)



Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic

Equivalent Medications for complete details

Gilotrif (Afatinib) Revised Revised prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Gilotrif (afatinib) for complete details

Humatrope (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Humatrope (somatropin) for complete details

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

Pharmacy Benefit Manager (PBM)

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

Jentadueto XR (Linagliptin/Metformin)


Pharmacy Benefit Manager (PBM)




Oxford

REVISED



Sep. 1, 2016 Keppra (Levetiracetam) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Keppra for complete details

(continued)

Keppra XR (Levetiracetam Extended

Release[XR])

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

details

Lamictal (Lamotrigine) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Lamictal for complete details

Lamictal ODT (Lamotrigine Orally

Disintegrating Tablets)

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

details

Lamictal XR (Lamotrigine Extended Release)

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

Lamotrigine XR Revised Revised coverage criteria/precertification requirements; removed step therapy guidelines and corresponding reference link to Step Therapy Guidelines: Lamotrigine

Revised prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Lamotrigine XR for complete details

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

Myalept (Metreleptin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Myalept (metreleptin) for complete details

Mysoline (Primidone) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Mysoline for complete details

Neurontin (Gabapentin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Neurontin for complete details

Norditropin AQ (Somatropin)

Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Norditropin (somatropin) for complete details

Norditropin (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Norditropin (somatropin) for complete details

Norditropin Nordiflex (Somatropin)

Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: NordiFlex (somatropin) for complete details



Oxford

REVISED



Sep. 1, 2016 Nuspin (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: NuSpin (somatropin) for complete details

Nutropin and Nutropin AQ (Somatropin)

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

Authorization/Medical Necessity Guidelines: Nutropin and Nutropin AQ (somatropin) for complete details

Omnitrope (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Omnitrope (somatropin) for complete details

Oxtellar XR (Oxcarbazepine Extended Release)

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

Procysbi (Cysteamine Bitartrate)

Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Procysbi (cysteamine bitartrate) for

complete details

Qudexy XR (Topiramate) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Qudexy XR for complete

details

Retin-A (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Retin-A and Retin-A Micro (tretinoin) for complete details

Retin-A Micro (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Retin-A and Retin-A Micro (tretinoin) for complete details

Retin-A Micro Pump (Tretinoin) (Brand and Generic)

Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Retin-A and Retin-A Micro (tretinoin) for complete details

Saizen (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Saizen (somatropin) for

complete details

Serostim (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Serostim (somatropin) for complete details

Sirturo (Bedaquiline)

Revised Revised coverage criteria/precertification requirements to indicate precertification is no longer required: o Removed language indicating precertification is required through the

Pharmacy Benefit Manager (PBM) o Removed therapeutic equivalent guidelines and corresponding

reference link to policy titled Drug Coverage Criteria - New and



Oxford

REVISED



Sep. 1, 2016 Sirturo (Bedaquiline) (continued)

Therapeutic Equivalent Medications

(continued) Spritam (Levetiracetam) Revised Revised coverage criteria/precertification requirements; added prior authorization/medical necessity guidelines; refer to Prior

Authorization/Medical Necessity Guidelines: Spritam for complete details

Stavzor (Valproic Acid) Removed Removed coverage guidelines/drug listing

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

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

Syprine (Trientine Hydrochloride)

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

Tazorac (Taxarotene) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tazorac (taxarotene) for complete details

Topamax (Topiramate) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Topamax for complete

details

Tretin-X 0.075% Cream (Tretinoin)

Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tretin-X (tretinoin) for complete details

Tretin-X 0.0375% Cream (Tretinoin)

Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tretin-X (tretinoin) for complete details

Tretin-X Kit (Tretinoin) Updated Updated prior authorization/notification guidelines; refer to Prior Authorization/Notification Guidelines: Tretin-X (tretinoin) for complete details

Trileptal (Oxcarbazepine)

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

Trokendi XR (Topiramate)

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

details

Uptravi (Selexipag) Revised Revised coverage criteria/precertification requirements; removed therapeutic equivalent guidelines and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Veltassa (Patiromer) Revised Revised coverage criteria/precertification requirements; added prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Veltassa for complete details



Oxford

REVISED



Sep. 1, 2016 Vimpat (Lacosamide): Tablet

Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Vimpat (Lacosamide) for complete details

Vonvendi (Von Willebrand Factor, Recombinant)




Vraylar (Cariprazine) Revised Revised coverage criteria/precertification requirements to indicate precertification is no longer required: o Removed language indicating precertification is required through the

Pharmacy Benefit Manager (PBM) o Removed therapeutic equivalent guidelines and corresponding

reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Xuriden (Uridine Triacetate)



o Added prior authorization/notification guidelines; refer to Prior Authorization/Notification Guideline: Xuriden for complete details

Zomacton (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Zomacton for complete details

Zonegran (Zonisamide) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Zonegran for complete

details

Zorbtive (Somatropin) Revised Revised prior authorization/medical necessity guidelines; refer to Prior Authorization/Medical Necessity Guidelines: Zorbtive (somatropin) for

complete details

REVISED


Obstructive Sleep Apnea Treatment

Oct. 1, 2016


Updated benefit considerations: o Removed language

indicating some benefit plan

Nonsurgical Treatment

Removable oral appliances are proven and medically necessary for treating obstructive sleep apnea (OSA) as documented by polysomnography. Refer to policy titled Attended Polysomnography for

Evaluation of Sleep Disorders for further information.



Oxford

REVISED


Obstructive Sleep Apnea Treatment (continued)

Oct. 1, 2016

documents contain explicit exclusions or limitations of coverage and/or allow for the use of patient selection criteria in determining

coverage

o Added instruction to check the member specific benefit plan document and any federal or state mandates, if applicable, prior to using this policy

Revised coverage rationale for surgical treatment: o Added reference link to the

policy titled Orthognathic (Jaw) Surgery for additional information regarding

medical necessity review for

maxillomandibular advancement (MMA) surgery

o Revised language pertaining to radiofrequency ablation of the soft palate and/or

tongue base to indicate this procedure is unproven and not medically necessary for treating obstructive sleep

apnea 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

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Oral Appliances (Mandibular Advancement Devices), A-0341 (ACG). Removable oral appliances are unproven and 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 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 medically necessary for treating obstructive sleep apnea as documented by polysomnography. Refer to 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. Uvulopalatopharyngoplasty (UPPP)

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Uvulopalatopharyngoplasty (UPPP), A-0245 (AC).

Maxillomandibular advancement surgery (MMA)

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, 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



Oxford

REVISED


Obstructive Sleep Apnea Treatment (continued)

Oct. 1, 2016

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

Updated supporting information

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

MCG™ Care Guidelines, 20th edition, 2016, Mandibular Osteotomy, A-0247 (ACG).

The following surgical procedures are unproven and not medically necessary for treating obstructive sleep apnea:

Laser-assisted uvulopalatoplasty (LAUP)

Palatal implants Lingual suspension - also referred to as tongue stabilization, tongue

stitch or tongue fixation Transoral robotic surgery (TORS) Implantable hypoglossal nerve stimulation Radiofrequency ablation of the soft palate and/or tongue base

There is insufficient evidence to conclude that laser-assisted uvulopalatoplasty (LAUP) results in improved apnea-hypopnea index (AHI) or

august 2016 policy update bulletin - oxhp · igg/iga, or igm type of paraproteinemic polyneuropathy...

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