-
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
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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.
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3 Oxford® Policy Update Bulletin: August 2016
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
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4 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
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
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5 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
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
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6 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
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:
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7 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
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8 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
Apheresis (continued)
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
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9 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
Apheresis (continued)
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)
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10 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
Apheresis (continued)
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
Reformatted and reorganized policy; transferred content to new
template
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
-
11 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
-
12 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
Reformatted and reorganized policy; transferred content to new
template
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
-
13 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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.
-
14 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
Meniscus Implant and Allograft
Aug. 1, 2016
Reformatted and reorganized policy; transferred content to new
template
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.
-
15 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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”
Updated list of applicable HCPCS codes: o Modified table
heading;
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
-
16 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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.
-
17 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
Updated list of applicable HCPCS codes: o Modified table
heading;
removed descriptor classifying codes as “non-reimbursable”
Updated supporting information to reflect the most current
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
Reformatted and reorganized policy; transferred content to new
template
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
-
18 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
UPDATED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
Updated supporting information to reflect the most current
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
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
-
19 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
Reformatted and reorganized policy; transferred content to new
template
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.
-
20 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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.
-
21 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
-
22 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Drug/Medication Status Summary of
Changes
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)
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: Cabometyx for complete
details
Cetylev (Acetylcysteine) 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
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
-
23 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Drug/Medication Status Summary of
Changes
Drug Coverage Guidelines (continued)
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)
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
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)
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
-
24 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Drug/Medication Status Summary of
Changes
Drug Coverage Guidelines
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
-
25 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Drug/Medication Status Summary of
Changes
Drug Coverage Guidelines (continued)
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
-
26 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Drug/Medication Status Summary of
Changes
Drug Coverage Guidelines
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
-
27 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Drug/Medication Status Summary of
Changes
Drug Coverage Guidelines (continued)
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)
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
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)
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 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
Policy Title Effective Date Summary of Changes Coverage
Rationale
Obstructive Sleep Apnea Treatment
Oct. 1, 2016
Reformatted and reorganized policy; transferred content to new
template
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.
-
28 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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
-
29 Oxford® Policy Update Bulletin: August 2016
Clinical Policy Updates
Oxford
REVISED
Policy Title Effective Date Summary of Changes Coverage
Rationale
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