Download March 2013 Medical Policy Updates

March 2013
Medical Policy Updates
Page
New:



Electrical and Ultrasound Bone Growth Stimulators - Effective Apr. 1, 2013........................................
Oscillatory Positive Expiratory Pressure Devices - Effective Apr. 1, 2013............................................
Pneumatic Compression Devices - Effective Apr. 1, 2013......................................................................
Updated:

Bone or Soft Tissue Healing and Fusion Enhancement Products - Effective Apr. 1, 2013.....................
Revised:









Abnormal Uterine Bleeding and Uterine Fibroids - Effective Apr. 1, 2013............................................
Apheresis - Effective Apr. 1, 2013...........................................................................................................
Bariatric Surgery - Effective Apr. 1, 2013................................................................................................
Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes - Effective Apr. 1, 2013
Deep Brain Stimulation - Effective Apr. 1, 2013......................................................................................
Elbow Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2013......................................................
Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Effective Apr. 1, 2013....
Fecal DNA Testing - Effective Apr. 1, 2013............................................................................................
Gastrointestinal Motility Disorders, Diagnosis and Treatment - Effective Apr. 1, 2013..........................
(continued on next page)
4
4
4
4
8
10
15
20
22
24
24
27
27
March 2013
Medical Policy Updates (continued)
Page
Revised:


























Gene Expression Testing - Effective Apr. 1, 2013...................................................................................
Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) - Effective Apr. 1,
2013...........................................................................................................................................................
Glaucoma Surgical Treatment - Effective Apr. 1, 2013...........................................................................
High Frequency Chest Wall Compression Devices - Effective Apr. 1, 2013..........................................
High Ligation and Endomechanical Ablation for Varicose Veins - Effective Apr. 1, 2013....................
Hip Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2013..........................................................
Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors - Effective Apr. 1, 2013
Infertility Diagnosis and Treatment - Effective Apr. 1, 2013...................................................................
Intensity-Modulated Radiation Therapy - Effective Apr. 1, 2013............................................................
Knee Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2013........................................................
Magnetoencephalography and Magnetic Source Imaging for Specific Neurological Applications Effective Apr. 1, 2013...............................................................................................................................
Mandibular Disorders - Effective Apr. 1, 2013........................................................................................
Mechanical Stretching and CPM Devices - Effective Apr. 1, 2013.........................................................
Noninvasive Prenatal Diagnosis of Fetal Aneuploidy Using Cell-Free Fetal Nucleic Acids in
Maternal Blood - Effective Apr. 1, 2013..................................................................................................
Non-Surgical Treatment of Obstructive Sleep Apnea - Effective Apr. 1, 2013.......................................
Outpatient Cardiovascular Telemetry - Effective Apr. 1, 2013................................................................
Plagiocephaly and Craniosynostosis - Effective Apr. 1, 2013..................................................................
Proton Beam Radiation Therapy - Effective Apr. 1, 2013........................................................................
Radiofrequency Therapy and Tibial Nerve Stimulation for Urinary Disorders - Effective Apr. 1, 2013
Shoulder Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2013..................................................
Surgical Treatment for Spine Pain - Effective Apr. 1, 2013.....................................................................
Surgical Treatment of Obstructive Sleep Apnea - Effective Apr. 1, 2013................................................
Total Artificial Heart - Effective Apr. 1, 2013..........................................................................................
Transcatheter Heart Valve Procedures - Effective Apr. 1, 2013...............................................................
Vagus Nerve Stimulation - Effective Apr. 1, 2013...................................................................................
Wireless Capsule Endoscopy - Effective Apr. 1, 2013.............................................................................
28
30
35
36
37
38
38
39
42
46
46
47
49
49
51
52
52
54
55
56
56
59
62
62
63
65
Drug and Biologics Policy Updates
New:

Repository Corticotropin Injection (H.P. Acthar Gel) - Effective Apr. 1, 2013.......................................
Updated:


Oncology Medication Clinical Coverage - Effective Apr. 1, 2013..........................................................
Remicade (infliximab) - Effective Apr. 1, 2013.......................................................................................
Revised:



Actemra (tocilizumab) - Effective Apr. 1, 2013.......................................................................................
Campath (alemtuzumab) - Effective Apr. 1, 2013....................................................................................
Immune Globulin (IVIG and SCIG) - Effective Apr. 1, 2013..................................................................
(continued on next page)
March 2013
67
68
70
75
73
75
March 2013
Drug and Biologics Policy Updates (continued)
Revised:


Orencia (abatacept) - Effective Apr. 1, 2013............................................................................................
Xolair (omalizumab) - Effective Apr. 1, 2013..........................................................................................
Page
94
95
Coverage Determination Guideline (CDG) Updates
New:

Private Duty Nursing - Effective May 1, 2013.........................................................................................
Updated:

Breast Reduction Surgery - Effective Apr. 1, 2013...................................................................................
Revised:













Blepharoplasty, Blepharoptosis, and Brow Ptosis Repair - Effective Apr. 1, 2013..................................
Complementary and Alternative Medicine - Effective Mar. 1, 2013........................................................
Cosmetic and Reconstructive Procedures - Effective Apr. 1, 2013..........................................................
Custodial and Skilled Care Services - Effective Apr. 1, 2013..................................................................
Gender Identify Disorder Treatment (Sex Transformation) - Effective Apr. 1, 2013..............................
Nutrition (Including: Counseling, Therapy, Enteral Nutrition, Infant Formula, Breast Milk,
Supplements and Food) - Effective May 1, 2013......................................................................................
Orthognathic (Jaw) Surgery - Effective Apr. 1, 2013...............................................................................
Preventive Care Services - Effective Apr. 1, 2013....................................................................................
Prosthetic Devices and Wigs - Effective Apr. 1, 2013..............................................................................
Rhinoplasty, Septoplasty, and Repair of Vestibular Stenosis - Effective Apr. 1, 2013............................
Specialized, Microprocessor or Myoelectric Limbs - Effective Apr. 1, 2013..........................................
Speech Language Pathology Services - Effective Apr. 1, 2013................................................................
Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins - Effective May 1,
2013...........................................................................................................................................................
98
100
100
100
100
100
101
102
102
102
103
103
104
104
104
Utilization Review Guideline (URG) Updates
New:

Breast Pumps - Effective Apr. 1, 2013......................................................................................................
Revised:


Chemotherapy Observation and Inpatient Hospitalization - Effective Apr. 1, 2013.................................
Durable Medical Equipment and Related Supplies, Prosthetics and Orthotics - Effective Apr. 1, 2013..
March 2013
105
106
107
Medical Policy Updates
NEW
Title
Electrical and
Ultrasound Bone
Growth
Stimulators
Effective Date
Apr. 1, 2013
Coverage Rationale
Two MCG™ are identified, one for electrical and electromagnetic bone growth
stimulators, and one for ultrasonic bone growth Stimulators.
For information regarding medical necessity review of electrical and
electromagnetic bone growth stimulators, when applicable, see MCG™ Care
Guidelines, 17th edition, 2013, Bone Growth Stimulators, Electrical and
Electromagnetic ACG: A-0565 (AC).
For information regarding medical necessity review of ultrasonic bone growth
stimulators, when applicable, see MCG™ Care Guidelines, 17th edition, 2013,
Bone Growth Stimulators, Ultrasonic ACG: A-0414 (AC).
Oscillatory
Positive
Expiratory
Pressure Devices
Apr. 1, 2013
For information regarding medical necessity review of oscillatory positive
expiratory pressure devices, when applicable, see MCG™ Care Guidelines,
17th edition, 2013, Noninvasive Positive Pressure Ventilation (CPAP, BiPAP)
ACG: A-0431 (AC).
Pneumatic
Compression
Devices
Apr. 1, 2013
For information regarding medical necessity review of pneumatic compression
devices, when applicable, see MCG™ Care Guidelines, 17th edition, 2013,
Intermittent Pneumatic Compression with Extremity Pump ACG: ACG: A0340 (AC).
Effective Date
Apr. 1, 2013
Summary of Changes
 Clarified coverage
rationale for platelet rich
plasma; replaced
language indicating
“platelet-rich plasma
(e.g., autologous platelet
derived growth factor) is
unproven when used to
enhance bone healing”
with “platelet-rich
plasma (e.g., autologous
platelet derived growth
factor) is unproven when
used to enhance bone or
soft tissue healing”
UPDATED
Title
Bone or Soft
Tissue Healing
and Fusion
Enhancement
Products
Coverage Rationale
Bone graft materials used in spinal fusion
surgery can be categorized into the
following domains:
 Autografts
 Allografts including (cadaver bone graft)
 Demineralized Bone Matrix (DBM)
 Bone Morphogenetic Proteins (BMP)
 Ceramic-based products
 Cell-based products
 Platelet-Rich Plasma
Autografts
Autografts are proven for bone fusion
enhancement:
Autografts harvest bone for grafting from the
person undergoing surgery. The harvested
bone is typically retrieved from the patient’s
own tibia, fibula or iliac crest and then placed
at the surgery site.
Allografts
Demineralized bone matrix (DBM) is a type
of allograft and is proven for bone fusion
enhancement.
Allografts harvest bone for grafting from a
4
March 2013
Medical Policy Updates
UPDATED
Title
Bone or Soft
Tissue Healing
and Fusion
Enhancement
Products
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
person other than the surgical candidate.
Cadaver bone is one type of allograft.
Allografts are proven for bone fusion
enhancement.
Bone Morphogenetic Proteins (BMP)
Bone Morphogenetic Protein-2 (rhBMP-2)
When used according to U.S. Food and
Drug Administration (FDA) labeled
indications, INFUSE Bone Graft is proven
for the enhancement of bone healing and/or
fusion of the lumbar spine in patients who
meet all of the following criteria:
 Implanted via an anterior approach and
used in conjunction with an INFUSE
Bone Graft fusion device.
INFUSE Bone Graft fusion devices
include:
o InFUSE™ bone graft/LT-Cage
o InFUSE™ bone graft/Lumbar
Tapered Fusion Device
o InFUSE™ bone graft/InterFix™
threaded fusion device
o InFUSE™ bone graft/Inter Fix™ RP
threaded fusion device
 Skeletally mature patient (18 years of age
or older or radiographic evidence of
epiphyseal closure) with degenerative
disc disease at one level from L4–S1
 No more than Grade I spondylolisthesis at
the involved level
 Failure of at least 6 months of nonoperative treatment
INFUSE Bone Graft is unproven for all
other indications including but not limited
to the following:
 Enhancement of bone healing and/or
fusion of the lumbar spine via a posterior
approach.
 Treatment of cervical spine or any other
area with or without use of other devices
including the PEEK device.
 Known contraindications including:
o hypersensitivity to recombinant
human Bone Morphogenetic Protein2, bovine Type I collagen or to other
components of the formulation
o Pregnancy
o Active infection at operative site or
patient has an allergy to titanium or
5
March 2013
Medical Policy Updates
UPDATED
Title
Bone or Soft
Tissue Healing
and Fusion
Enhancement
Products
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
titanium alloy
 Planned use of grafting in the vicinity of a
resected or extant tumor
 Skeletally immature patient (younger than
18 years of age or 18 years of age or older
with no radiographic evidence of
epiphyseal closure)
Posterolateral or posterior lumbar interbody
fusion utilizing INFUSE Bone Graft has not
received FDA approval. Available studies
have demonstrated increased adverse events
with the posterior approach. The safety and
effectiveness of INFUSE Bone Graft in the
cervical spine have not been demonstrated.
There is insufficient clinical evidence to
support the use of INFUSE Bone Graft with
devices made of PEEK or other biocompatible
materials. In addition, INFUSE Bone Graft
has not been approved by the FDA for use
with PEEK cages.
When used according to U.S. Food and
Drug Administration (FDA) indications,
the INFUSE/MASTERGRAFTTM
Posterolateral Revision Device system is
proven in patients who meet all of the
following criteria:
 Implanted via a posterolateral approach
 Presence of symptomatic posterolateral
lumbar spine pseudoarthrosis
 Skeletally mature patient (older than 21
years of age or radiographic evidence of
epiphyseal closure)
 Treatment of 2 or more levels of the
lumbar spine
 Autologous bone and/or bone marrow
harvest is not feasible or is not expected
to promote fusion. These patients are
diabetics and smokers.
The INFUSE/MASTERGRAFTTM
Posterolateral Revision Device system is
unproven for all other indications including
the following:
 Known contraindications including:
o hypersensitivity to recombinant
human Bone Morphogenetic Protein2, bovine Type I collagen or to other
components of the formulation
o Known active malignancy or patients
6
March 2013
Medical Policy Updates
UPDATED
Title
Bone or Soft
Tissue Healing
and Fusion
Enhancement
Products
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
undergoing treatment for a
malignancy
o Pregnancy
o Active infection at operative site
 Planned use of grafting in the vicinity of a
resected or extant tumor
 Skeletally immature patient (older than 21
years of age or radiographic evidence of
epiphyseal closure)
 INFUSE/MASTERGRAFTTM
Posterolateral Revision Device system
has not received FDA approval for any
other indications except those indicated as
proven. The safety and effectiveness of
INFUSE/MASTERGRAFTTM
Posterolateral Revision Device system
has not been demonstrated for other
conditions in studies published in peerreviewed literature.
Bone Morphogenetic Protein-7 (BMP-7)
OP-1 Implant and OP-1 Putty are
unproven for the enhancement of bone
healing and/or fusion with or without use of
other devices (including the PEEK device).
Use of BMP7 has not demonstrated
accelerated healing. In one study better results
were achieved in patients receiving traditional
autograft. Additionally, available studies have
been limited by substantial loss of study
participants at follow-up as well as by short
follow-up times.
Bone graft substitutes have overlapping
properties and are made of a variety of
materials such as polymers (degradable and
nondegradable), ceramics and composites
(calcium phosphate, calcium sulfate, and
bioactive glass), factor-based techniques
(recombinant growth factors) and cell-based
techniques (mesenchymal stem cells).
Ceramic-based products:
Ceramic –based products such as beta
tricalcium phosphate (b-TCP) when used
alone or with bone marrow aspirate are
unproven for the enhancement of bone
healing and/or fusion.
Only very weak conclusions about
effectiveness of ceramic-based products may
be drawn from studies because of small
sample size, lack of control or comparison
7
March 2013
Medical Policy Updates
UPDATED
Title
Bone or Soft
Tissue Healing
and Fusion
Enhancement
Products
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
groups in most studies. The absence of a
formal assessment of clinical outcomes in
most studies limits the conclusions that can be
drawn about the place of b-TCP in bone
healing and fusion. Furthermore, definitive
patient selection criteria have not been
established for the use of b-TCP bone void
fillers.
Cell-based products:
Cell based products such as mesenchymal
stem cells, Osteocel, or Trinity Evolution
are unproven for the enhancement of bone
healing.
Available clinical evidence is insufficient to
establish the safety and efficacy for the use of
bone graft or cell-based substitutes.
Platelet-Rich Plasma
Platelet-rich plasma (e.g., autologous
platelet derived growth factor) is unproven
when used to enhance bone or soft tissue
healing.
Evidence in the published scientific literature
is inconsistent and does not lend strong
support to the clinical utility of using PRP to
augment bone or soft tissue healing.
OptiMesh®
The OptiMesh deployable grafting system
is unproven.
There is insufficient evidence that the use of
OptiMesh will improve structural support of
the vertebrae. Further studies are needed to
evaluate safety and efficacy of this grafting
system.
Information Pertaining to Medical
Necessity Review (When Applicable)
No criteria in addition to the above indications
apply to medical necessity review.
REVISED
Title
Abnormal Uterine
Bleeding and
Uterine Fibroids
Effective Date
Apr. 1, 2013
Summary of Changes
 Revised coverage
rationale:
o Added information
pertaining to medical
necessity review
(when applicable)
o Replaced references
Coverage Rationale
Endometrial Ablation
Endometrial ablation, using the following
techniques, is proven for treating
menorrhagia or metrorrhagia in
premenopausal women:
 Cryoablation (HerOption®)
8
March 2013
Medical Policy Updates
REVISED
Title
Abnormal Uterine
Bleeding and
Uterine Fibroids
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
to “Milliman Care
Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th
edition, 2013”
(effective 04/01/13)
Coverage Rationale
 Thermal balloon ablation (Gynecare
Thermachoice®)
 Hydrothermal ablation (Hydro
ThermAblator®)
 Radiofrequency ablation (NovaSure®)
 Microwave ablation (Microsulis®
Microwave Endometrial Ablation (MEA)
System)
 Manual endometrial ablation techniques
such as resectoscopic ablation or laser
ablation
Levonorgestrel-Releasing Intrauterine
Device
The levonorgestrel-releasing intrauterine
device (LNG-IUD) is proven for treating
menorrhagia in premenopausal women.
Uterine Fibroids
Uterine artery embolization (UAE) is
proven for treating symptomatic uterine
fibroids for women who do NOT wish to
preserve their childbearing potential.
Uterine artery embolization (UAE) is
unproven for treating symptomatic uterine
fibroids for women who wish to preserve
their childbearing potential.
The effects of UAE on ovarian and uterine
function and on fertility are relatively
unknown. Further studies of safety and/or
efficacy in published, peer-reviewed medical
literature are necessary.
Magnetic resonance imaging (MRI)-guided
cryoablation is unproven for treating
uterine fibroids.
The published evidence on MRI-guided
cryoablation for uterine fibroids is very
limited, as the procedure has been evaluated in
very few patients. The long-term outcomes
and overall health benefits remain unknown.
Further long-term studies on larger samples
published in peer-reviewed medical literature
are necessary to demonstrate the safety and
efficacy of this technology.
Magnetic resonance imaging (MRI)-guided
focused ultrasound ablation (FUA) is
unproven for treating uterine fibroids.
Further studies are needed to determine the
long-term efficacy of this procedure and to
9
March 2013
Medical Policy Updates
REVISED
Title
Abnormal Uterine
Bleeding and
Uterine Fibroids
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
evaluate the efficacy and safety of this
procedure relative to other treatments for
uterine fibroids. See the Benefit
Considerations section for potential coverage
of unproven services.
Information Pertaining to Medical
Necessity Review (When Applicable)
Endometrial Ablation
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th Edition, 2012,
Hysteroscopy, with or without Endometrial
Resection, Ablation or Myomectomy, ACG:
A-0286 (AC). Refer to section on endometrial
ablation.
Uterine Artery Embolization
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th Edition, 2012, Uterine
Artery Embolization, ACG: A-0287 (AC).
Apheresis
Apr. 1, 2013

Revised list of proven
indications:
o Added:

Prophylaxis of
cardiac
transplant
rejection

Sickle cell
disease for one
of the
following:
- Red blood cell
exchange for
treating acute
stroke, acute
chest syndrome,
or multiorgan
failure
- Prophylaxis
with red blood
cell exchange
for primary or
secondary
stroke
prevention or
for prevention
of transfusional
iron overload
o Replaced “familial
Therapeutic apheresis is proven for the
following 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; Se´zary syndrome,
10
March 2013
Medical Policy Updates
REVISED
Title
Apheresis
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
hypercholesterolemi
a (plasma exchange
or selective
adsorption)” with
“heterozygous or
homozygous
familial
hypercholesterolemi
a (plasma exchange
or selective
adsorption)”
 Revised list of unproven
indications; removed
sickle cell disease
 Added information
pertaining to medical
necessity review (when
applicable)
 Updated list of applicable
(proven) ICD-9 diagnosis
codes; added 282.41,
282.42, 289.52, 282.60,
282.61, 282.62, 282.63,
282.64, 282.68 and
282.69
 Updated list of applicable
ICD-10 diagnosis codes
(preview draft effective
10/01/14); added D57.1,
D57.01, D57.02, D57.20,
D57.211, D57.212,
D57.811, D57.812,
D57.80, D57.811,
D57.812, D57.411,
D57.412, D57.40,
D57.02, D57.212,
D57.412 and D57.812
Coverage Rationale
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)
 Hyperviscosity in monoclonal
gammopathies, treatment of symptoms
(plasma exchange)
 IgG/IgA, or IgM type of paraproteinemic
polyneuropathy (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:
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 for:
 ABO incompatible solid organ
transplantation, liver perioperative
 Acute disseminated encephalomyelitis
 Acute liver failure
 Age related macular degeneration
 Amyloidosis, systemic
11
March 2013
Medical Policy Updates
REVISED
Title
Apheresis
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
 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, nonerythrodermic
 Dermatomyositis or polymyositis
 Dilated cardiomyopathy
 Graft-versus-host disease, skin, acute
 Graft-versus-host disease, non-skin,
acute/chronic
 Hereditary hemochromatosis
 Hemolytic uremic syndrome
 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
 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
12
March 2013
Medical Policy Updates
REVISED
Title
Apheresis
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
 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: drugassociated
 Thrombotic microangiopathy:
hematopoietic stem cell transplantassociated
 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 proven.
Information Pertaining to Medical
Necessity Review (When Applicable)
Apheresis is first-line therapy for the
following conditions which do not require
medical necessity review:
 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)
13
March 2013
Medical Policy Updates
REVISED
Title
Apheresis
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
 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 medically necessary for persons
who are refractory to or intolerant of standard
therapy for the following conditions 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)
 ABO incompatible kidney transplantation
(plasma exchange)
 Cardiac allograft rejection
(photopheresis)
 Focal segmental glomerulosclerosis,
recurrent (plasma exchange)
 Heterozygous familial
hypercholesterolemia (plasma exchange
or selective adsorption)
14
March 2013
Medical Policy Updates
REVISED
Title
Apheresis
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
 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)
Bariatric Surgery
Apr. 1, 2013

Bariatric surgery, as a primary treatment
for weight loss is proven for the following:
1. Class III obesity (BMI > 40 kg/m2)
2. Class II obesity (BMI 35-39.9 kg/m2) in
the presence of one or more of the
following co-morbidities:
 Type 2 diabetes
 Cardiovascular disease (e.g., stroke,
myocardial infarction, poorly
controlled hypertension (systolic
blood pressure greater than 140 mm
Hg or diastolic blood pressure 90 mm
Hg or greater, despite
pharmacotherapy)
 History of coronary artery disease
with a surgical intervention such as
cardiopulmonary bypass or
percutaneous transluminal coronary
angioplasty
 Cardiopulmonary problems (e.g.,
documented obstructive sleep apnea
(OSA) confirmed on
polysomnography with an AHI or
RDI of >= 30 (as defined by AASM
Task Force. Sleep.1999;22:667-89)
 History of cardiomyopathy


Reorganized policy
content
Updated description of
services to reflect most
current clinical evidence
and references
Reformatted and revised
coverage rationale:
o Updated/expanded
class II obesity (BMI
35-39.9 kg/m2) comorbidity
descriptions for
cardiovascular
disease and lifethreatening
cardiopulmonary
problems
o Added criteria for
medical necessity
review (when
applicable)
o Removed language
indicating vertical
banded gastroplasty
(gastric banding;
gastric stapling),
biliopancreatic
bypass (Scopinaro
procedure), and
biliopancreatic
diversion with
duodenal switch are
not first-line
procedures for the
general bariatric
surgery patient
o Replaced references
The following bariatric surgical procedures
are proven in adults for the treatment of
clinically severe obesity as defined by the
National Heart Lung and Blood Institute
(NHLBI):
 Gastric bypass (Roux-en-Y; gastrojejunal
anastomosis)
 Adjustable gastric banding (laparoscopic
adjustable silicone gastric banding)
 Gastric sleeve procedure (also known as
laparoscopic vertical gastrectomy or
15
March 2013
Medical Policy Updates
REVISED
Title
Bariatric Surgery
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
to “morbid obesity”
with “extreme
obesity” (per
updated National
Heart, Lung and
Blood Institute
(NHLBI)
classification)
Coverage Rationale
laparoscopic sleeve gastrectomy)
 Vertical banded gastroplasty (gastric
banding; gastric stapling)
 Biliopancreatic bypass (Scopinaro
procedure)
 Biliopancreatic diversion with duodenal
switch
Some bariatric surgical procedures are
proven in adolescents for the treatment of
clinically severe obesity as defined by the
National Heart Lung and Blood Institute
(NHLBI) and who have:
 Achieved greater than 95% of estimated
adult height based on documented
individual growth pattern; AND
 A minimum Tanner stage of 4
The following bariatric surgeries are
proven in adolescents:
 Gastric bypass (Roux-en-Y; gastrojejunal
anastomosis)
 Adjustable gastric banding (laparoscopic
adjustable silicone gastric banding)
 Gastric sleeve procedure (also known as
laparoscopic vertical gastrectomy or
laparoscopic sleeve gastrectomy)
Robotic assisted gastric bypass surgery is
proven non-preferentially as equivalent but
not superior to other types of minimally
invasive bariatric surgery.
Surgical revision or a second bariatric
surgery is proven for inadequate weight
loss if the original criteria for bariatric
surgery (BMI, co-morbidities and patient
selection criteria) continue to be met.
Surgical adjustment or alteration of a prior
bariatric procedure is proven for
complications of the original surgery, such
as stricture, obstruction, pouch dilatation,
erosion, or band slippage when the
complication causes abdominal pain,
inability to eat or drink or causes vomiting
of prescribed meals.
Bariatric surgical procedures in a person
who has not attained an adult level of
physical development and maturation are
16
March 2013
Medical Policy Updates
REVISED
Title
Bariatric Surgery
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
unproven.
Potential safety issues must be addressed in
studies with sufficient sample size and
adequate follow-up times necessary to
demonstrate the impact of the surgery on
physical, sexual and reproductive maturation
and the long term improvement of comorbidities in this age group.
Transoral endoscopic surgery (such as
transoral gastroplasty [TOGA®],
StomaphyX, and Restorative Obesity
Surgery, Endoluminal [ROSE] procedure)
is unproven as a treatment for obesity.
The medical device used for TOGA has not
received FDA approval. A clinical trial is
currently underway to evaluate the safety and
effectiveness of TOGA. Further studies are
needed to determine the safety and efficacy of
StomaphyX and the Rose procedure for the
revision of gastric bypass surgery to reduce
the stomach pouch and stomach outlet (stoma)
to the original gastric bypass size.
The mini-gastric bypass (MGB), also
known as laparoscopic mini-gastric bypass
(LMGBP) is unproven.
Further studies are needed to determine the
safety and efficacy of mini-gastric bypass
surgery. In addition, patient selection criteria
must be better defined for this procedure.
Gastric electrical stimulation with an
implantable gastric stimulator (IGS) is
unproven.
Further studies are needed to determine the
safety and efficacy of gastric electrical
stimulation with an implantable gastric
stimulator as an option for treating obesity
with bariatric surgery.
Vagus nerve blocking (VNB) or vagal
blocking therapy is unproven for treatment
of obesity.
Further studies are needed to determine the
safety and efficacy of Vagus nerve blocking
as a treatment option for obesity.
Intragastric balloon is unproven as a
treatment for obesity.
Further studies are needed to determine the
safety and efficacy of intragastric balloon as a
17
March 2013
Medical Policy Updates
REVISED
Title
Bariatric Surgery
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
treatment option for obesity.
Gastrointestinal liners (EndoBarrier) are
investigational and unproven as a
treatment for obesity. Gastrointestinal liners
have not received FDA approval.
Laparoscopic greater curvature plication,
also known as total gastric vertical
plication, is unproven for the treatment of
obesity.
Further studies are needed to evaluate the
safety and efficacy of performing lower
greater curvature plication for the treatment of
obesity.
Bariatric surgery to treat gynecological
abnormalities, osteoarthritis, gallstones,
urinary stress incontinence or as a
treatment for gastroesophageal reflux
(including for Barrett’s esophagus or
gastroparesis), and other obesity associated
diseases that generally do not lead to life
threatening consequences is unproven.
There is insufficient published clinical
evidence to support bariatric surgery for the
treatment of gynecological abnormalities,
osteoarthritis, gallstones, urinary stress
incontinence or as a primary treatment for
gastroesophageal reflux and other obesity
associated diseases. Bariatric surgery will
frequently ameliorate symptoms of comorbidities such as gastroesophageal reflux
disease and obstructive sleep apnea. However,
the primary purpose of bariatric in obese
person’s surgery is to achieve weight loss.
Additional information for medical
necessity review, where applicable:
Bariatric surgery is medically necessary
when ALL of the following criteria have
been met:
 Body mass index (BMI) = or > 40 kg/m2
or BMI 35.0-39.9 kg/m2 with one or
more of the medical comorbidities
described above.
 Documentation of a motivated attempt of
weight loss through a structured diet
program, prior to bariatric surgery, which
includes physician or other health care
provider notes and/or diet or weight loss
logs from a structured weight loss
18
March 2013
Medical Policy Updates
REVISED
Title
Bariatric Surgery
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
program for a minimum of 6 months.
(NHLBI, 1998)
 Psychological evaluation to rule out
major mental health disorders which
would contraindicate surgery and
determine patient compliance with postoperative follow-up care and dietary
guidelines. (NHLBI, 1998)
The National Heart, Lung and Blood Institute
(NHLBI) classify the ranges of BMI in adults
as follows (NHLBI, 1998):
 <18.5 - Underweight
 18.5 to 24.9 kg/m2 - Normal
 25-29.9 kg/m2 - Overweight
 30-34.9 kg/m2 - Obesity Class I
 35-39.9 kg/m2 - Obesity Class II
 > 40 kg/m2 –Extreme Obesity Class III
Extreme obesity or Class III obesity as
described in a 1998 NHLBI guideline was
also addressed in previous consensus
statements as morbid obesity. The term
“clinically severe obesity” is preferred to the
once commonly used term “morbid obesity”
and is described in the NHLBI practical guide
document of 2000. “Surgery is an option for
well-informed and motivated patients who
have clinically severe obesity (BMI ≥ 40) or a
BMI ≥ 35 and serious comorbid conditions.”
(NHLBI 2000)
For adolescents, physical development and
maturation may be determined utilizing the
gender specific growth chart and BMI chart.
Male Growth Chart
Female Growth Chart
Male BMI Chart
Female BMI Chart
Estimated adult height may also be calculated
utilizing the Mid-Parental height calculation
(FP Notebook, 2008):
Boy
 In: (Father's Height + Mother's Height +
5) / 2
 Cm: (Father's Height + Mother's Height +
19
March 2013
Medical Policy Updates
REVISED
Title
Bariatric Surgery
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
13) / 2
Girl
 In: (Father's Height - 5 + Mother's
Height) / 2
 Cm: (Father's Height - 13 + Mother's
Height) / 2
Refer to the policy for information on Tanner
Stages.
Continuous
Glucose
Monitoring and
Insulin Delivery
for Managing
Diabetes
Apr. 1, 2013

Revised coverage
rationale:
o Added information
pertaining to medical
necessity review
(when applicable)
o Replaced references
to “Milliman Care
Guidelines®, 16th
edition, 2012” with
“MCG™ care
guidelines, 17th
edition, 2013”
(effective 04/01/13)
Insulin Delivery
External insulin pumps that deliver insulin
by continuous subcutaneous infusion are
proven for treating patients with diabetes.
Disposable external insulin pumps are
considered equivalent to standard insulin
pumps.
Implantable insulin pumps are
investigational and unproven.
No implantable insulin pumps have received
U.S. Food and Drug Administration (FDA)
approval at this time. While some preliminary
studies reported improved glycemic control
and fewer episodes of hypoglycemia in
carefully selected patients, complications such
as catheter blockage and infection were
observed. Larger, randomized controlled
trials are needed to determine the long term
impact of implantable insulin pumps on
diabetes management.
Insulin infuser ports, such as the i-port®
Injection Port, are unproven for insulin
delivery in patients with diabetes.
There is insufficient evidence demonstrating
that the use of insulin infuser ports results in
improved glycemic control beyond what can
be achieved by using standard insulin delivery
methods. In addition, an increase in
complications, such as infection at the port
site, has been reported when using these
devices. Further well-designed, large-scale
randomized controlled trials are needed to
establish the safety and efficacy of this device.
Continuous Glucose Monitors with or
without Combined Insulin Pumps
Long-term continuous glucose monitoring
(greater than 72 hours), alone or in
combination with an external insulin pump,
is proven as a supplement to self-
20
March 2013
Medical Policy Updates
REVISED
Title
Continuous
Glucose
Monitoring and
Insulin Delivery
for Managing
Diabetes
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
monitoring of blood glucose (SMBG) for
type 1 diabetes patients who meet EITHER
of the following criteria AND have
demonstrated adherence to a physician
ordered diabetic treatment plan:
 Have been unable to achieve optimum
glycemic control as defined by the most
current version of the American Diabetes
Association (ADA) Standards of Medical
Care in Diabetes; OR
 Have experienced hypoglycemia
unawareness
ADA Standards of Medical Care in Diabetes
available at:
http://professional.diabetes.org/ResourcesForP
rofessionals.aspx?cid=84160. Accessed
March 30, 2012.
Long-term continuous glucose monitoring
is unproven for patients with type 2
diabetes or gestational diabetes.
There is insufficient evidence that the use of
long-term continuous glucose monitoring
leads to improvement of glycemic control in
persons with type 2 or gestational diabetes.
Closed-Loop Combined Systems
External insulin pumps and continuous
blood glucose monitors, combined into a
single closed-loop system not requiring
direct patient interaction, are
investigational and unproven.
No closed-loop systems have received FDA
approval at this time. Study results fail to
provide conclusive evidence that closed-loop
systems lead to improved health outcomes in
persons with diabetes. This system has only
been tested in closed-loop mode for short
periods of time in a small number of patients
who were receiving more intensive medical
care than is typical for most persons with
diabetes. There is insufficient evidence that
improved health outcomes, if any, are durable
over time. Further controlled studies with
larger numbers of patients and longer periods
of closed-loop insulin management are needed
to assess the safety and efficacy of these
systems.
Remote Glucose Monitoring
Remote glucose monitoring (e.g.,
21
March 2013
Medical Policy Updates
REVISED
Title
Continuous
Glucose
Monitoring and
Insulin Delivery
for Managing
Diabetes
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
mySentry™) is unproven for managing
patients with diabetes.
There is insufficient evidence in the clinical
literature to conclude that remote glucose
monitoring demonstrates improvement in
clinical outcomes.
Additional Information
As part of the ongoing effort to improve
diabetes care, the National Diabetes Education
Program, the American Association of
Clinical Endocrinology and others have
recommended the term "A1c" be used for
GHB or hemoglobin A1c (HbA1c)
measurement in health care practice to avoid
confusion.
Information Pertaining to Medical
Necessity Review (When Applicable)
Insulin Delivery
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th edition, 2012, Insulin
Infusion Pump ACG:A-0339 (AC).
Continuous Glucose Monitoring
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th edition, 2012, Continuous
Glucose Monitoring ACG:A-0126 (AC).
Deep Brain
Stimulation
Apr. 1, 2013


Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Updated list of applicable
ICD-10 diagnosis codes
(preview draft effective
10/01/14); removed
G24.09 and G25.1
Deep brain stimulation is proven for
treating the following:
 Idiopathic Parkinson's disease when used
according to U.S. Food and Drug
Administration (FDA) indications
 Essential tremor when used according to
U.S. Food and Drug Administration
(FDA) indications
 Primary dystonia* (occurs apart from any
other identifiable illness) including
generalized and/or segmental dystonia,
hemidystonia and cervical dystonia
(torticollis) when used according to the
U.S. Food and Drug Administration
(FDA) indications
*Primary dystonia may include genetic
torsion dystonia, acquired torsion
dystonia (not due to drugs), spasmodic
torticollis, fragments of torsion dystonia,
and unspecified torticollis.
Deep brain stimulation is unproven for
22
March 2013
Medical Policy Updates
REVISED
Title
Deep Brain
Stimulation
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
treating secondary Parkinsonism (result of
head trauma, metabolic conditions, toxicity,
drugs, or other medical disorders).
Well-designed studies demonstrating the
efficacy of deep brain stimulation for treating
secondary Parkinsonism are not available.
Clinical trials are needed to demonstrate the
benefit of deep brain stimulation for this
patient population.
Deep brain stimulation is unproven for
treating secondary dystonia (occurs with
illness, after trauma or following exposure
to certain medications or toxins).
There is inadequate evidence of the safety and
efficacy of deep brain stimulation for treating
secondary dystonia. Questions remain with
regard to patient selection criteria and longterm benefits and safety compared with
standard treatments. Formal comparisons,
with large randomized controlled or
comparative trials of pallidotomy,
thalamotomy, and deep brain stimulation, are
required before conclusions can be drawn
regarding the use of deep brain stimulation for
patients with secondary dystonia.
Deep brain stimulation is unproven for
treating conditions other than those listed
as proven. This includes but is not limited
to the following diagnoses:
 Depression
 Obsessive-compulsive disorder (OCD)
 Epilepsy
 Tourette syndrome
 Cluster headache
 Impulsive or violent behavior
 Chronic pain
 Trigeminal neuralgia
 Movement disorders caused by multiple
sclerosis (MS)
Some studies have examined the use of deep
brain stimulation for treating major
depression, obsessive-compulsive disorder
(OCD), epilepsy, Tourette syndrome, cluster
headache, impulsive or violent behavior,
stroke pain, chronic pain, phantom limb pain,
trigeminal neuralgia and movement disorders
of multiple sclerosis (MS). However, because
of limited studies, small sample sizes, weak
study designs and heterogenous patient
23
March 2013
Medical Policy Updates
REVISED
Title
Deep Brain
Stimulation
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
characteristics, there is insufficient data to
conclude that deep brain stimulation is safe
and/or effective for treating these indications.
Information Pertaining to Medical
Necessity Review (When Applicable)
Deep brain stimulation is medically necessary
for idiopathic Parkinson's disease, essential
tremor, or primary dystonia if signs or
symptoms persist despite standard medical
therapy.
Elbow
Replacement
Surgery
(Arthroplasty)
Apr. 1, 2013

Revised coverage
rationale; replaced
references to “Milliman
Care Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th edition,
2013” (effective
04/01/13)
For information regarding medical necessity
review, when applicable, see MCG™ Care
Guidelines, 17th edition, 2013, Elbow
Arthroplasty, S-420 (ISC).
Electrical
Stimulation for
the Treatment of
Pain and Muscle
Rehabilitation
Apr. 1, 2013

Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Updated list of applicable
CPT codes; added 63650,
63655, 63661, 63662,
63663, 63664, 63685 and
63688
Functional electrical stimulation (FES), a
form of neuromuscular electrical
stimulation (such as Parastep I), is proven
for rehabilitation in persons with paralyzed
lower limbs due to spinal cord injury (SCI)
with all of the following characteristics:
 Intact lower motor units (L1 and below)
(both muscle and peripheral nerves)
 Muscle and joint stability for weight
bearing at upper and lower extremities
that can demonstrate balance and control
to maintain an upright support posture
independently;
 Demonstrate brisk muscle contraction to
NMES and have sensory perception of
electrical stimulation sufficient for
muscle contraction;
 Possess high motivation, commitment and
cognitive ability to use such devices for
walking;
 Able to transfer independently and
demonstrate independent standing
tolerance for at least 3 minutes;
 Demonstrate hand and finger function to
manipulate controls;
 Post recovery from spinal cord injury and
restorative surgery of at least 6-months;
 No hip and knee degenerative disease and
no history of long bone fracture
secondary to osteoporosis

24
March 2013
Medical Policy Updates
REVISED
Title
Electrical
Stimulation for
the Treatment of
Pain and Muscle
Rehabilitation
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Functional electrical stimulation (such as
ERGYS, RT300 or ODFS Dropped Foot
Stimulator) is unproven for the treatment
of disuse muscle atrophy in persons with
spinal cord injury (who do not meet the
requirements above) or multiple sclerosis.
Further studies are needed to confirm that
functional electrical stimulation promotes
bone remineralization and prevents or reverses
muscle atrophy. Only a few studies have
looked at FES as a modality of treatment of
multiple sclerosis, and the results are limited
and conflicting regarding whether FES
improves treatment outcomes in multiple
sclerosis when offered in addition to other
rehabilitative treatment modalities.
Functional electrical stimulation (such as
Walkaide, NESS L300 or ODFS Dropped
Foot Stimulator) is unproven for the
treatment of gait disorders (e.g., foot drop)
of central neurologic origin including but
not limited to stroke or multiple sclerosis.
There is insufficient evidence in the peer
reviewed literature that use of functional
electrical stimulation will improve health
outcomes in patients with gait disorders.
Published studies have included small
heterogeneous patient populations, short-term
follow-ups, and various treatment protocols,
outcome measures, and FES devices. Only a
few studies have looked at FES as a modality
of treatment of multiple sclerosis, and the
results are limited and conflicting regarding
whether FES improves treatment outcomes in
multiple sclerosis when offered in addition to
other rehabilitative treatment modalities.
Neuromuscular electrical stimulation
(NMES) is proven for:
A. Treatment of disuse muscle atrophy
if:
 The nerve supply to the muscle
is intact; and
 The disuse muscle atrophy is not
of neurological origin but
originates from conditions such
as casting, splinting or
contractures.
B. Treatment to improve wrist and
finger function and prevent or correct
shoulder subluxation in persons with
25
March 2013
Medical Policy Updates
REVISED
Title
Electrical
Stimulation for
the Treatment of
Pain and Muscle
Rehabilitation
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
partial paralysis following stroke
Neuromuscular electrical stimulation
(NMES) is unproven for the treatment of
neurologic, orthopedic (e.g., scoliosis) or
other abnormalities including pain not
listed as proven. Additionally, there is
insufficient evidence for NMES for all other
indications.
There is insufficient evidence in the peer
reviewed literature that use of electrical
stimulation will improve health outcomes for
the treatment of neurologic or orthopedic
conditions other than those identified above as
proven. Randomized, controlled trials are
necessary to assess the durability of this
procedure in comparison to other types of
treatment.
Interferential therapy (IFT) is proven for
the treatment of pain associated with
musculoskeletal disorders or injuries, and
stimulating healing of nonsurgical soft
tissue injuries.
Interferential therapy is unproven to
facilitate the healing of bone fractures.
There is insufficient evidence from the
available studies to conclude that interferential
therapy promotes healing of bone fractures.
None of the double-blind, randomized,
placebo-controlled studies reported a positive
treatment effect of interferential therapy for
bone fractures.
Pulsed electrical stimulation (PES) is
unproven for the treatment of
osteoarthritis.
There is insufficient evidence to conclude that
PES provides health benefits to patients with
osteoarthritis. Randomized, controlled trials
are necessary to assess the durability of this
procedure in comparison to other types of
treatment.
Peripheral subcutaneous field stimulation
(PSFS) or peripheral nerve field
stimulation (PNFS) is unproven for the
treatment of pain.
Evidence for the effectiveness of PSFS or
PNFS based on controlled studies is lacking.
Randomized controlled trials are needed to
26
March 2013
Medical Policy Updates
REVISED
Title
Electrical
Stimulation for
the Treatment of
Pain and Muscle
Rehabilitation
(continued)
Effective Date
Apr. 1, 2013
Fecal DNA
Testing
Apr. 1, 2013
Summary of Changes
Information Pertaining to Medical
Necessity Review (When Applicable)
The above indications apply to medical
necessity review.


Gastrointestinal
Motility
Disorders,
Diagnosis and
Treatment
Coverage Rationale
evaluate the efficacy of this treatment.
Apr. 1, 2013

Updated description of
services to reflect most
current clinical evidence,
FDA information and
references
Revised coverage
rationale; replaced
language indicating
“fecal DNA testing for
colorectal cancer
screening and/or
monitoring is
investigational due to
lack of U.S. Food and
Drug Administration
(FDA) approval” with
“fecal DNA testing for
colorectal cancer
screening and/or
monitoring is unproven
and investigational due
to lack of U.S. Food and
Drug Administration
(FDA) approval”
Fecal DNA testing for colorectal cancer
screening and/or monitoring is unproven
and investigational due to lack of U.S. Food
and Drug Administration (FDA) approval.
Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Gastric electrical stimulation therapy is
proven for the treatment of chronic,
intractable (drug-refractory) nausea and
vomiting secondary to gastroparesis of
diabetic or idiopathic etiology when used
according to U.S. Food and Drug
Administration (FDA) labeled indications.
See the U.S. Food and Drug Administration
(FDA) section for information regarding FDA
labeling and Humanitarian Device Exemption
(HDE) for gastric electrical stimulation.
There is insufficient evidence in the clinical
literature supporting the diagnostic accuracy
of fecal DNA tests to screen for colorectal
cancer in asymptomatic, average-risk patients.
The existing evidence has little or no
applicability to currently available fecal DNA
tests. Further studies are needed to determine
the analytic and clinical validity of the test as
compared to other screening methods.
At this time, no tests have received FDA
approval. Until the FDA completes its review
of fecal DNA tests, they are investigational.
The FDA has classified DNA testing as a
device; therefore, it is subject to FDA review.
The SmartPill® wireless gastrointestinal
motility monitoring system is proven for
diagnosing and evaluating gastrointestinal
motility disorders including gastroparesis
when used according to FDA labeled
indications.
See the U.S. Food and Drug Administration
(FDA) section of policy for information
27
March 2013
Medical Policy Updates
REVISED
Title
Gastrointestinal
Motility
Disorders,
Diagnosis and
Treatment
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
regarding FDA labeling and indications for
SmartPill.
The following tests are proven for
evaluating anorectal function:
 Rectal sensation, tone, and compliance
test
 Anorectal manometry
Cutaneous, mucous, or serosal
electrogastrography is unproven for
diagnosing gastric disorders including
gastroparesis.
There is insufficient evidence to conclude that
electrogastrography can accurately diagnose
gastroparesis and other gastric disorders.
There are no data to conclude that
electrogastrography is beneficial for health
outcomes in patients with gastric disorders.
Colonic manometry is unproven for
evaluating colon motility.
There is insufficient clinical evidence of
efficacy in the published peer-reviewed
medical literature for the use of colon motility
testing or colonic manometry. Patient
selection criteria and the role of colonic
manometry in the management of motility
abnormalities such as refractory constipation
must be better defined in statistically robust,
well-designed clinical trials.
Information Pertaining to Medical
Necessity Review (When Applicable)
The SmartPill® wireless gastrointestinal
motility monitoring system is medically
necessary when earlier diagnostic tests have
failed to identify the cause of symptoms
consistent with a gastrointestinal motility
disorder.
Gastric electrical stimulation is medically
necessary for refractory diabetic gastroparesis
that has failed other therapies.
Gene Expression
Testing
Apr. 1, 2013

Revised coverage
rationale for oncology
related services/
treatment; added
language to indicate:
o Multi-panel gene
expression tests
Oncology
Multi-panel gene expression tests (e.g.,
Afirma®) are proven for assessing thyroid
nodules that are not clearly benign or
malignant based on fine-needle aspiration
biopsy results alone.
28
March 2013
Medical Policy Updates
REVISED
Title
Gene Expression
Testing
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
(e.g., Afirma®) are
proven for assessing
thyroid nodules that
are not clearly
benign or malignant
based on fine-needle
aspiration biopsy
results alone
o Gene expression
tests are unproven
for predicting
metastatic risk of
uveal melanoma
(e.g., DecisionDxUM)
 Updated list of applicable
ICD-9 diagnosis codes;
added 241.0, 241.1,
241.9, 226, 242.00,
242.01, 242.10, 242.11,
242.20, 242.21, 242.30,
242.31, 242.40, 242.41,
242.80, 242.81, 242.90,
242.91, V10.87, 153.0,
153.1, 153.2, 153.3,
153.4, 153.5, 153.6,
153.7, 153.8, 153.9,
190.1, 190.6, 190.8,
190.9, 203.00, 203.01,
203.02, 203.10, 203.11,
203.12, 203.80, 203.81,
203.82, 205.00, 205.01,
205.02, 205.10, 205.11,
205.12, 205.20, 205.21,
205.22, 205.80, 205.81,
205.82, 205.90, 205.91,
205.92, 207.00, 207.01,
207.02, 207.20, 207.21,
207.22, 207.80, 207.81,
207.82, 209.10, 209.11,
209.12, 209.13, 209.14,
209.15, 209.16, 209.26,
209.27, 209.50, 209.51,
209.52, 209.53, 209.54,
209.55, 209.56, 209.66,
209.67, 238.6, 429.0,
429.1, 429.2, 429.3,
429.81, 429.82, 429.83,
429.89, 429.9, V10.05,
V10.84, V17.41, V17.49,
V81.2 and 795.82
Coverage Rationale
Gene expression tests are unproven for the
following:
 Predicting the likelihood of colon cancer
recurrence (e.g., Oncotype DX® Colon
Cancer Assay)
 Guiding therapy in patients with myeloma
(e.g., MyPRS™)
 Identifying tissue of origin in difficult to
diagnose cancers (e.g., Pathwork®
Diagnostics Tissue of Origin or
CancerTYPE ID®)
 Predicting metastatic risk of uveal
melanoma (e.g., DecisionDx-UM)
There is insufficient evidence in the clinical
literature demonstrating that these tests have a
role in clinical decision-making or have a
beneficial effect on health outcomes. Further
studies are needed to determine the analytic
validity, clinical validity and/or clinical utility
of these tests.
Non-Oncology
Gene expression tests are unproven for the
following:
 Assessing cardiovascular risk (e.g.,
Corus® CAD)
There is insufficient evidence in the clinical
literature demonstrating that this test has a
role in clinical decision-making or has a
beneficial effect on health outcomes. Further
studies are needed to determine the analytic
validity, clinical validity and clinical utility of
this test.
29
March 2013
Medical Policy Updates
REVISED
Title
Genetic Testing
for Hereditary
Breast and/or
Ovarian Cancer
Syndrome
(HBOC)
Effective Date
Apr. 1, 2013
Summary of Changes
• Revised coverage
rationale:
o Removed language
indicating genetic
counseling is
strongly
recommended after
genetic testing for
BRCA mutations
o Added information
pertaining to medical
necessity review
(when applicable)
• Reformatted list of
applicable CPT codes;
created new table
heading for codes related
to large genomic
rearrangements/ BART
(CPT code 81213)
Coverage Rationale
This policy discusses genetic testing for
hereditary breast and/or ovarian cancer
(HBOC) syndrome otherwise known as
BRCA1 and BRCA2.
Definitions: Please note, for the purpose of
this policy:
1.
Close blood relatives are defined as
follows:
a. First degree relatives include
parents, siblings and offspring
b. Second degree relatives include
half-brothers/sisters,
aunts/uncles, grandparents,
grandchildren and
nieces/nephews affected on the
same side of the family
c. Third degree relatives include
first cousins, great-aunts/uncles,
great-grandchildren and great
grandparents affected on same
side of family
2.
A breast cancer diagnosis includes either
invasive or non-invasive (ductal
carcinoma in situ) types.
3.
Ovarian cancer also includes fallopian
tube cancers and primary peritoneal
carcinoma.
4.
Limited family history is defined as
having fewer than two known first-degree
or second-degree female relatives or
female relatives surviving beyond 45
years of age on either or both sides of the
family. (e.g., individual who is adopted)
5.
Documentation of personal and family
history should be in the contemporaneous
medical records submitted with the
testing request (i.e., request form).
6.
For the statements that include age
guidelines, a person is considered to be
45 years of age up until the day before
their 46th birthday, and a person is
considered to be 50 years of age up until
the day before their 51st birthday.
7.
Two breast primary cancers include
30
March 2013
Medical Policy Updates
REVISED
Title
Genetic Testing
for Hereditary
Breast and/or
Ovarian Cancer
Syndrome
(HBOC)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
cancers appearing at the same time
(synchronous) and one is not a metastasis
of the other; or primary cancers
developing at intervals (metachronous or
asynchronous). The tumors may be in one
or two breasts.
8.
HBOC-associated malignancies include
prostate cancer, pancreatic cancer or
melanoma. The presence of these
malignancies does not necessarily justify
BRCA testing. For example, a female
with breast cancer over age 50 whose
sister had melanoma at 40 and whose
father has prostate cancer would meet
criteria. In another example, a female
with breast cancer over age 50 whose
maternal aunt had pancreatic cancer and
whose paternal uncle had prostate cancer
would not meet criteria because the aunt
and uncle are on different sides of the
family.
9.
Triple-negative breast cancer refers to any
breast cancer that does not express the
genes for estrogen receptor (ER),
progesterone receptor (PR) or HER2/neu.
This subtype of breast cancer is clinically
characterized as more aggressive and less
responsive to standard treatment and is
associated with poorer overall patient
prognosis. It is diagnosed more
frequently in younger women, women
with BRCA1 mutations and those
belonging to African-American and
Hispanic ethnic groups.
Genetic Counseling
Genetic counseling is strongly recommended
prior to and after genetic testing for BRCA
mutations in order to inform persons being
tested about the advantages and limitations of
a specific genetic test as applied to a unique
person.
BRCA Testing Criteria
I. BRCA1 and BRCA2 testing is proven
for women with a personal history of
breast cancer in the following
situations:
A. Breast cancer diagnosed at age 45
31
March 2013
Medical Policy Updates
REVISED
Title
Genetic Testing
for Hereditary
Breast and/or
Ovarian Cancer
Syndrome
(HBOC)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
or younger with or without family
history; OR
B. Breast cancer diagnosed at age 50
or younger with:
1. At least one close blood
relative with breast cancer
at age 50 or younger; OR
2. At least one close blood
relative with ovarian
cancer; OR
3. Limited family history
(see Definitions section
for further clarification)
C.
Breast cancer diagnosed at any
age with:
1. Two breast primary
cancers, when first breast
cancer diagnosis occurred
prior to age 50 OR
2. Two breast primary
cancers in a single
individual with at least
one close blood relative
with breast cancer
diagnosed at age 50 years
or younger; OR
3. Two breast primary
cancers in a single
individual with at least
one close blood relative
with ovarian cancer; OR
4. Personal history of
ovarian cancer; OR
5. At least two close blood
relatives on the same side
of the family with breast,
ovarian and/or pancreatic
cancer at any age; OR
6. Close male blood relative
with breast cancer; OR
7. At least one close blood
relative that has a BRCA1
or BRCA2 mutation; OR
8. At least two close blood
relatives on the same side
of the family with other
HBOC syndrome
associated malignancies
(prostate, pancreatic,
melanoma); OR
32
March 2013
Medical Policy Updates
REVISED
Title
Genetic Testing
for Hereditary
Breast and/or
Ovarian Cancer
Syndrome
(HBOC)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
9. Ashkenazi Jewish or
ethnic groups associated
with higher mutation
frequency such as,
Icelandic, Swedish, Dutch
or Hungarian descent
D. Triple negative breast cancer
diagnosed at age 60 or younger.
II. BRCA1 and BRCA2 testing is proven
for women with a personal history of
ovarian cancer.
III. BRCA1 and BRCA2 testing is proven
for women and men with a personal
history of pancreatic cancer at any age
and at least two close blood relatives on
the same side of the family with breast,
ovarian and/or pancreatic cancer at any
age.
IV. BRCA1 and BRCA2 testing is proven
for men with a personal history of
breast cancer.
V. BRCA1 and BRCA2 testing is proven
for men and women without a personal
history of breast or ovarian cancer with:
A. At least one first- or second-degree
blood relative meeting any of the
above criteria
(I-IV) OR
B. At least one third-degree blood
relative with breast cancer and/or
ovarian cancer who has at least 2
close blood relatives with breast
cancer (at least one with breast
cancer at age 50 or younger) and/or
ovarian cancer OR
C. A known BRCA1/BRCA2
mutation in the family (defined as
first-, second- or third-degree
relative)
VI. BRCA1 and/or BRCA2 testing is
unproven for all other indications
including screening of breast or ovarian
cancers or for risk assessment of other
cancers. While the BRCA mutation is
known to be associated with other
33
March 2013
Medical Policy Updates
REVISED
Title
Genetic Testing
for Hereditary
Breast and/or
Ovarian Cancer
Syndrome
(HBOC)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
cancers such as prostate, pancreas and
melanoma, as part of the Hereditary
Breast Ovarian Cancer Syndrome
(HBOC), BRCA testing is not indicated
when one of these cancers is isolated in
the family.
Information Pertaining to Medical
Necessity Review (When Applicable)
The above criteria apply to medical necessity
review.
Additional Information
Note: If there are no living family members
with breast or ovarian cancer, consider
testing family members affected with cancers
thought to be associated with BRCA1/BRCA2,
prostate and pancreatic cancers and
melanoma.
Large Genomic Rearrangement Testing
i.
Detection of large genomic
rearrangements (e.g.,
BRACAnalysis® Large
Rearrangement Test (BART)) is
proven for individuals who meet the
testing criteria for BRCA1/BRCA2
and have no known familial
BRCA1/BRCA2 mutations*.
Information Pertaining to Medical
Necessity Review (When
Applicable)
Detection of large genomic
rearrangements (e.g.,
BRACAnalysis® Large
Rearrangement Test (BART)) is
medically necessary when the
following criteria are met:
A. Individual meets the testing
criteria for BRCA1/BRCA2
and has no known familial
BRCA1/BRCA2 mutations*
B. Testing is conducted on an
affected family member
with the highest likelihood
of a BRCA1/BRCA2
mutation (NCCN, 2012)
C. Test is limited to one per
34
March 2013
Medical Policy Updates
REVISED
Title
Genetic Testing
for Hereditary
Breast and/or
Ovarian Cancer
Syndrome
(HBOC)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
family (defined as first
degree relatives: parents,
siblings and offspring)

I.
Glaucoma
Surgical
Treatment
Apr. 1, 2013

Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Reflex testing will be
applied by Myriad Genetics
if original BRCA test results
are negative. Reflex testing
is defined as follow-up
testing automatically
initiated when certain test
results are observed in the
laboratory.
Detection of large genomic
rearrangements (e.g.,
BRACAnalysis® Large
Rearrangement Test (BART)) is
unproven for the purpose of
screening in the general population.
There is inadequate clinical evidence
that such screening reduces mortality
from breast cancer in a normal risk
population.
Glaucoma drainage devices, such as the
ExPRESS™ mini glaucoma shunt, Molteno
implant, Baerveldt tube shunt, Krupin Eye
Valve, or the Ahmed glaucoma valve
implant, are proven when used according
to U.S. Food and Drug Administration
(FDA) labeled indications.
The iStent® Trabecular Micro-Bypass Stent
System is unproven for the treatment of
glaucoma.
There is insufficient evidence demonstrating
the efficacy of iStent for treating glaucoma.
There are no long-term large studies that
address the efficacy of the iStent compared to
other intraocular pressure-lowering devices or
procedures. Well-designed studies with larger
patient populations and longer follow-up are
required to demonstrate the safety and benefits
of this device.
Glaucoma drainage devices, such as
Eyepass, DeepLight SOLX® Gold Shunt
and other shunts that do not have FDA
approval are investigational and unproven
for the treatment of glaucoma.
Clinical evidence is limited to small studies;
35
March 2013
Medical Policy Updates
REVISED
Title
Glaucoma
Surgical
Treatment
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
therefore, additional studies are needed to
establish the safety and efficacy of these
devices.
Canaloplasty is proven for the treatment of
primary open-angle glaucoma.
Viscocanalostomy is unproven for the
treatment of glaucoma. Evidence from the
majority of available randomized controlled
trials indicates that viscocanalostomy is not as
effective as trabeculectomy in reducing
intraocular pressure (IOP).
Transciliary fistulization is unproven for
the treatment of glaucoma.
Further studies are needed to evaluate longterm safety and efficacy in comparison to
established filtering procedures. The currently
available published data are insufficient to
draw any conclusion regarding health
outcomes of transciliary fistulization for the
treatment of glaucoma.
Information Pertaining to Medical
Necessity Review (When Applicable)
The use of aqueous shunts or glaucoma
drainage devices with the ExPRESS™ mini
glaucoma shunt, Molteno implant, Baerveldt
tube shunt, Krupin Eye Valve, or the Ahmed
glaucoma valve implant is medically
necessary for treatment of refractory
glaucoma when there is intolerance,
contraindication, or failure of topical or oral
medication.
High Frequency
Chest Wall
Compression
Devices
Apr. 1, 2013

Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
High-frequency chest wall compression
(HFCWC), as a form of chest physical
therapy, is proven for treating or
preventing pulmonary complications of the
following conditions:
 Cystic fibrosis (CF)
 Bronchiectasis
High-frequency chest wall compression
(HFCWC), as a form of chest physical
therapy, is unproven for diagnoses other
than cystic fibrosis and bronchiectasis,
including, but not limited to respiratory
symptoms attributed to neuromuscular
disorders when they compromise
respiration, such as amyotrophic lateral
36
March 2013
Medical Policy Updates
REVISED
Title
High Frequency
Chest Wall
Compression
Devices
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
sclerosis (ALS), cerebral palsy, familial
dysautonomia, muscular dystrophy or
quadriplegia.
The evidence regarding the efficacy of
HFCWC therapy in patients with non-CF or
bronchiectasis-related disorders of airway
clearance is very limited and thus insufficient
to support definitive conclusions regarding the
use of this technology in these patient
populations. It remains to be proven if the
primary benefit of HFCWC therapy is
reduction in labor required to administer CPT
or if there are other benefits, such as improved
compliance or quality of life, better airway
clearance, reduced infection rate or
improvements in other outcomes. Larger,
long-term studies will be necessary to
adequately evaluate the relative benefits of
HFCWC compared with conventional CPT or
other types of respiratory therapy.
Information Pertaining to Medical
Necessity Review (When Applicable)
The above criteria apply to medical necessity
review.
High Ligation and
Endomechanical
Ablation for
Varicose Veins
Apr. 1, 2013


Updated description of
services to reflect most
current clinical evidence
and references
Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Ligation of the great saphenous vein at the
saphenofemoral junction, as a stand-alone
procedure, is unproven for treating venous
reflux. Ligation performed without stripping
or ablation is associated with high long-term
recurrence rates due to neovascularization.
Ligation of the small saphenous vein at the
saphenopopliteal junction, as a stand-alone
procedure, is unproven for treating venous
reflux.
Ligation performed without stripping or
ablation is associated with high long-term
recurrence rates due to neovascularization.
Ligation at the saphenofemoral junction, as
a stand-alone procedure, is proven, when
used in patients with ascending superficial
thrombophlebitis, to prevent the
propagation of an active clot from the
superficial system to the deep venous
system.
Ligation at the saphenofemoral junction, as
an adjunct to radiofrequency ablation or
endovenous laser ablation of the main
saphenous veins, is unproven. Published
37
March 2013
Medical Policy Updates
REVISED
Title
High Ligation and
Endomechanical
Ablation for
Varicose Veins
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
clinical evidence has not demonstrated that the
addition of saphenofemoral ligation to
endovenous ablation procedures provides an
additive benefit in resolving venous reflux or
preventing varicose vein recurrence.
Endovenous ablation is a clinically effective
therapy for treating venous reflux. Adding
ligation to the procedure adds clinical risk
without adding clinical benefit.
Endomechanical ablation of varicose veins
using a percutaneous infusion catheter,
such as ClariVein®, is unproven for
treating venous reflux. There is insufficient
evidence in the clinical literature supporting
the safety and efficacy of endomechanical
ablation for treating varicose veins. Further
results from large, well-designed studies are
needed to support the clinical utility of this
approach.
See the Coverage Determination Guidelines
titled Surgical and Ablative Procedures for
Venous Insufficiency and Varicose Veins for
information on additional vein procedures.
Information Pertaining to Medical
Necessity Review (When Applicable)
Ligation at the saphenofemoral junction, as a
stand-alone procedure, is medically necessary
to prevent the propagation of an active clot to
the deep venous system in patients with
ascending superficial thrombophlebitis who
fail or are intolerant of anticoagulation
therapy.
Apr. 1, 2013
Hip Replacement
Surgery
(Arthroplasty)
Implantable BetaEmitting
Microspheres for
Treatment of
Malignant
Tumors
Apr. 1, 2013


Revised coverage
rationale; replaced
references to “Milliman
Care Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th edition,
2013” (effective
04/01/13)
For information regarding medical necessity
review, when applicable, see MCG™ Care
Guidelines, 17th edition, 2013, Hip
Arthroplasty, S-560 (ISC).
Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Yttrium-90 (90Y) microsphere
radioembolization (SIR-Spheres® or
TheraSphere®) is proven for the following
indications:
 Unresectable metastatic liver tumors from
primary colorectal cancer (CRC)
For information regarding medical necessity
review, when applicable, see MCG™ Care
Guidelines, 17th edition, 2013, Hip: Displaced
Fracture of Femoral Neck, Hemiarthroplasty,
S-600 (ISC).
38
March 2013
Medical Policy Updates
REVISED
Title
Implantable BetaEmitting
Microspheres for
Treatment of
Malignant
Tumors
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
 Unresectable metastatic liver tumors from
neuroendocrine tumors
 Unresectable primary hepatocellular
carcinoma (HCC)
Yttrium-90 (90Y) microsphere
radioembolization (SIR-Spheres® or
TheraSphere®) is unproven for all other
indications.
Limited evidence suggests that treatment with
intrahepatic microsphere radiation (IMR)
might shrink tumors and relieve symptoms in
some patients, sometimes enough to render
some inoperable tumors operable. However,
limited available evidence has not shown
improved survival. In addition, the treatment's
potential impact on quality of life has not been
studied. No studies have yet compared the
effects of IMR therapy with alternative
treatments, such as chemoembolization.
Randomized controlled trials are needed to
determine the clinical utility of this treatment.
Information Pertaining to Medical
Necessity Review (When Applicable)
The above indications apply to medical
necessity review.
Infertility
Diagnosis and
Treatment
Apr. 1, 2013

Updated benefit
considerations; added
language to indicate
infertility services are
always subject to
mandate review. Several
states mandate benefit
coverage for certain
infertility services, but
the requirements for
coverage vary from state
to state; legislative
mandates and the
member-specific benefit
document must be
reviewed when
determining benefit
coverage for infertility
services
Diagnostic Procedures
The following procedures are proven for
use in diagnosing infertility in female
patients:
 Chromotubation of oviduct
 Cultures (cervical, vaginal, uterine)
 Hormone assay (luteinizing hormone
(LH), follicle stimulating hormone (FSH),
progesterone, prolactin, estradiol, thyroid,
clomiphene citrate challenge test)
 Hysterosalpingogram
 Hysteroscopy
 Laparoscopy
 Pelvic ultrasound (abdominal or vaginal)
 Sonohysterography or saline contrast
hysterosonography
The following procedures are proven for
use in diagnosing infertility in male
patients:
 Antisperm antibodies
 Cultures (genital)
 Hormone assay (LH, FSH, prolactin,
39
March 2013
Medical Policy Updates
REVISED
Title
Infertility
Diagnosis and
Treatment
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
testosterone)
 Leukocyte count in semen
 Rectal ultrasound (indicated when
ejaculatory duct obstruction is suspected)
 Scrotal ultrasound
 Semen analysis
 Testicular biopsy
 Vasography
The following tests are unproven for
diagnosing infertility:
 Computer-assisted sperm analysis
(CASA)
 Hemizona assay test
 Hyaluronan binding assay (HBA)
 Sperm DNA integrity testing (e.g. Sperm
Chromatin Structure Assay (SCSA),
Comet assay, sperm DNA fragmentation
assay, TUNEL assay, Sperm DNA
Decondensation™ Test (SDD))
 Sperm penetration tests such as postcoital
cervical mucus penetration, sperm
penetration assay (SPA), zona-free
hamster egg assay or sperm acrosome
reaction assay
 Uterine/endometrial receptivity testing
(e.g., E-tegrity® and Endometrial
Function Test® (EFT))
There is insufficient evidence to permit
conclusions regarding the use of these tests.
More studies are needed to support improved
outcomes (i.e., increased successful
pregnancies with delivery of liveborn
children) with use of these diagnostic tests.
Therapeutic Procedures
The following procedures are proven for
the treatment of infertility:
 Ovulation induction
 Insemination procedures (intrauterine
insemination (IUI) and artificial
insemination (AI) including sperm
washing)
 Assisted reproductive technologies
(gamete intrafallopian transfer (GIFT), in
vitro fertilization (IVF) and zygote
intrafallopian transfer (ZIFT))
 Assisted embryo hatching
 Intracytoplasmic sperm injection (ICSI)
for treatment of male factor infertility
40
March 2013
Medical Policy Updates
REVISED
Title
Infertility
Diagnosis and
Treatment
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
 Sperm retrieval techniques (including
microsurgical epididymal sperm
aspiration (MESA), percutaneous
epididymal sperm aspiration (PESA), and
testicular sperm extraction (TESE), and
electroejaculation)
The following procedures to correct
underlying disorders are proven for the
treatment of infertility:
 Ablation or lysis of adhesions and/or
surgical treatment of endometriosis,
laparoscopic or open
 Drainage of ovarian cyst
 Fimbrioplasty
 Transurethral resection of ejaculatory
ducts for treatment of ejaculatory duct
obstruction
 Varicocele repair
 Wedge resection of ovary or ovarian
drilling in women with polycystic ovary
syndrome. (NOTE: Ovarian drilling is a
measure of last resort due to the increased
risk of the formation of pelvic adhesions.)
The following procedures are unproven for
treating infertility:
 Co-culture of embryos
 EmbryoGlue®
 Partial zonal dissection (PZD)
 Subzonal sperm insertion (SUZI) (also
referred to as SCI)
Studies describe different techniques of coculture of embryos, but no standardized
method of co-culturing has been defined. The
use of co-cultures may improve blastocyst
development but may not result in an
improved pregnancy or delivery rate. There is
inadequate published scientific data to permit
conclusions regarding the use of EmbryoGlue.
Intracytoplasmic sperm injection (ICSI) has
largely replaced partial zonal dissection (PZD)
and subzonal sperm insertion (SCI, SUZI)
procedures. While results of one study are
promising for the use of the Wurn Technique,
there were no other studies to substantiate or
replicate these results. There is no research to
indicate that biomechanical dysfunction is a
barrier to pregnancy.
41
March 2013
Medical Policy Updates
REVISED
Title
Infertility
Diagnosis and
Treatment
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Cryopreservation of sperm, semen or
embryos is proven for individuals who are
infertile or are planning to undergo
therapies that threaten their reproductive
health such as cancer chemotherapy.
Cryopreservation of oocytes (eggs) is
unproven.
Although oocyte banking can be an option for
women who have no partner at the time of
cancer diagnosis, research indicates that
unfertilized oocytes are more prone to damage
during cryopreservation procedures than
embryos, and as a result, the overall
pregnancy rates may be lower than standard in
vitro fertilization (IVF) procedures. New
methods are developing rapidly; however,
their use as a means to have a child after
cancer treatment must be considered
investigational and offered only with
appropriate informed consent in a research
setting and under the auspices of an
institutional review board (IRB).
Cryopreservation of ovarian or testicular
tissue is unproven.
Ovarian tissue banking remains a promising
clinical technique because it avoids ovarian
stimulation and provides the opportunity for
preserving gonadal function in prepubertal, as
well as adult patients. However, this
procedure has produced very few live births.
Testicular tissue or testis xenografting are in
the early phases of experimentation and have
not yet been successfully tested in humans.
IntensityModulated
Radiation
Therapy
Apr. 1, 2013

Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Breast Cancer
Intensity-modulated radiation therapy
(IMRT) is proven preferentially* for
treating breast cancer when homogeneity of
dose is essential and the patient has at least
one of the following conditions:
 Macromastia as defined by cup size of D
or larger
 Separation of 25.5 cm or more in the
intra-thoracic distance from the midpoint
of the posterior light field border of the
medial tangential field to the midpoint of
the posterior light field of the lateral
tangential field.
IMRT is proven non-preferentially* (offers
no clinical advantage over standard
42
March 2013
Medical Policy Updates
REVISED
Title
IntensityModulated
Radiation
Therapy
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
therapy) for treating all other cases of
breast cancer.
There is no difference in the criteria used for
IMRT for male and female patients with
breast cancer.
Primary Bone and Articular Cartilage
Cancer
IMRT is proven preferentially* for treating
primary bone and articular cartilage
cancer of the skull and face, vertebral
column, sacrum and coccyx when sparing
the surrounding normal tissue from
radiation therapy exposure is essential.
Other Cancers
IMRT is proven preferentially* for treating
the following:
 Anal cancer
 Esophageal cancer
 Pancreatic cancer
 Prostate cancer
 Trachea cancer
 Head and neck cancers including the
following sites: lip; eye; thyroid; salivary
glands; hypopharynx; oropharynx;
nasopharynx; other parts of the pharynx
not explicitly identified here; oral cavity;
tongue; nasal cavities; middle ear;
accessory sinuses; larynx; lymph nodes of
the head, face and neck; pituitary gland,
pineal gland, carotid body; and skin of
lip, eyelid, ear and external auditory canal
 Malignant (primary and secondary) and
benign nervous system neoplasms of the
following: brain including cranial nerves
and cerebral meninges, spinal cord
including spinal meninges
*See the Benefit Considerations section of
policy for more information.
The use of compensator based beam
modulation treatment is proven when done
in combination with an IMRT indication
that is listed above as proven preferentially
or non-preferentially.
IMRT is proven non-preferentially* for
treating cervical cancer in individuals who
have had a hysterectomy.
43
March 2013
Medical Policy Updates
REVISED
Title
IntensityModulated
Radiation
Therapy
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
IMRT is unproven for treating the
following:
 Colon cancer
 Gastric cancer
 Gynecological cancer (except where
noted above)
 Lung cancer
 Lymphoma
 Pelvic bone cancer
 Primary or secondary liver cancer
 Rectal cancer
 Secondary bone and articular cartilage
cancer
 Soft tissue sarcoma and all other
neoplasms not listed above as proven
Some studies have examined the use of IMRT
for treating other cancers such as colon,
rectum, uterus, stomach, liver, lung,
lymphoma, and soft tissue neoplasms.
However, because of limited studies, small
sample sizes and weak study designs, there is
insufficient data to conclude that IMRT is safe
or effective for treating these neoplasms.
There is also little evidence to indicate that
IMRT increases survival in patients with these
neoplasms.
Intensity-modulated radiation therapy
(IMRT) may be covered for a diagnosis
that is listed above as unproven for unusual
cases when at least one of the following
conditions is present:
 The target volume is in close proximity to
critical structures that must be protected
 An immediately adjacent area has been
previously irradiated and abutting portals
must be established with high precision
Requests for these exceptions will be
evaluated by an independent radiation
oncologist. UnitedHealthcare will make a
coverage decision based on this review.
Intra-fraction localization and tracking
systems such as the Calypso® 4D
Localization System are unproven for use
in guiding radiotherapy.
Results of available studies suggest that the
Calypso System can provide continuous
information to guide prostate radiotherapy.
44
March 2013
Medical Policy Updates
REVISED
Title
IntensityModulated
Radiation
Therapy
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
However, although this technology has the
potential to reduce complications of
radiotherapy and improve local tumor control,
none of the available studies reported clinical
information related to the safety or efficacy of
radiation therapy guided by the Calypso
System. Further studies are needed to
determine whether guidance of radiotherapy
with the Calypso System benefits patients
who have localized prostate cancer.
Intensity-modulated radiation therapy used
in conjunction with proton beam radiation
therapy is unproven.
Clinical evidence is insufficient to support the
combined use of these technologies in a single
treatment plan. Comparative effectiveness
studies including randomized controlled trials
are needed to demonstrate the safety and longterm efficacy of combined therapy.
Information Pertaining to Medical
Necessity Review (When Applicable)
IMRT is medically necessary for treating
breast cancer when homogeneity of dose is
essential and the patient has at least one of
the following conditions:
 Macromastia as defined by cup size of D
or larger
 Separation of 25.5 cm or more in the
intra-thoracic distance from the midpoint
of the posterior light field border of the
medial tangential field to the midpoint of
the posterior light field of the lateral
tangential field.
IMRT is medically necessary for the
following preferential indications:
 Primary bone and articular cartilage
cancer of the skull and face, vertebral
column, sacrum and coccyx when sparing
the surrounding normal tissue from
radiation therapy exposure is essential
 Anal cancer
 Esophageal cancer
 Pancreatic cancer
 Prostate cancer
 Trachea cancer
 Head and neck cancers including the
following sites: lip; eye; thyroid; salivary
glands; hypopharynx; oropharynx;
nasopharynx; other parts of the pharynx
45
March 2013
Medical Policy Updates
REVISED
Title
IntensityModulated
Radiation
Therapy
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
not explicitly identified here; oral cavity;
tongue; nasal cavities; middle ear;
accessory sinuses; larynx; lymph nodes of
the head, face and neck; pituitary gland,
pineal gland, carotid body; and skin of
lip, eyelid, ear and external auditory canal
 Malignant (primary and secondary) and
benign nervous system neoplasms of the
following: brain including cranial nerves
and cerebral meninges, spinal cord
including spinal meninges
IMRT is medically necessary for
indications other than those listed above
when at least one of the following
conditions is present:
 The target volume is in close proximity to
critical structures that must be protected
 An immediately adjacent area has been
previously irradiated and abutting portals
must be established with high precision
Knee
Replacement
Surgery
(Arthroplasty)
Apr. 1, 2013

Revised coverage
rationale; replaced
references to “Milliman
Care Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th edition,
2013” (effective
04/01/13)
For information regarding medical necessity
review, when applicable, see MCG™ Care
Guidelines, 17th edition, 2013, Knee
Arthroplasty, S-700 (ISC).
Magnetoencephalography and
Magnetic Source
Imaging for
Specific
Neurological
Applications
Apr. 1, 2013

Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Magnetoencephalography and magnetic
source imaging (MEG/MSI) are proven for
the following:
 Presurgical evaluation in patients with
intractable focal epilepsy
 Presurgical evaluation of brain tumors
and vascular malformations
Magnetoencephalography and magnetic
source imaging (MEG/MSI) are unproven
for the evaluation of brain function in
patients with trauma, stroke, learning
disorders, or other neurologic disorders
and psychiatric conditions such as
schizophrenia.
There is insufficient evidence to conclude that
the use of MEG/MSI improves health
outcomes such as improved diagnostic
accuracy and treatment planning for patients
with trauma, stroke, learning disorders, or
46
March 2013
Medical Policy Updates
REVISED
Title
Magnetoencephalography and
Magnetic Source
Imaging for
Specific
Neurological
Applications
(continued)
Effective Date
Apr. 1, 2013
Mandibular
Disorders
Apr. 1, 2013
Summary of Changes
Coverage Rationale
other neurologic disorders and psychiatric
conditions. Further clinical trials
demonstrating the clinical usefulness of this
procedure are necessary before it can be
considered proven to have a benefit on health
outcomes for these conditions.
Information Pertaining to Medical
Necessity Review (When Applicable)
Magnetoencephalography and magnetic
source imaging are medically necessary for
pre-surgical planning for refractory epilepsy
when other standard methods do not localize a
seizure focus.



Updated description of
services to reflect most
current clinical evidence
and references
Revised coverage
rationale:
o Added information
pertaining to medical
necessity review
(when applicable)
o Replaced references
to “Milliman Care
Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th
edition, 2013”
(effective 04/01/13)
Updated list of applicable
CPT codes; removed
21247
The following services are proven for
treating disorders of the
temporomandibular joint (TMJ):
 Arthrocentesis
 Arthroplasty
 Arthroscopy (with or without FDA
approved bone anchor devices)
 Arthrotomy/open joint surgery (with or
without FDA approved bone anchor
devices)
 Injections of corticosteroids for
rheumatoid arthritis-related TMJ
disorders
 Physical therapy
 Stabilization and repositioning splint
therapy (This does not include the
Dynasplint system which is discussed
below.)
Not all services treat all TMJ disorders;
specific treatments are based upon the specific
diagnosis.
The following services are unproven for
treating disorders of the
temporomandibular joint (TMJ):
 Partial or total joint replacement with
artificial prosthesis
 Biofeedback
 Craniosacral manipulation
 Passive rehabilitation therapy
 Low-load prolonged-duration stretch
(LLPS) devices such as the Dynasplint
system
Published studies have not demonstrated
47
March 2013
Medical Policy Updates
REVISED
Title
Mandibular
Disorders
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
convincingly that artificial implants for
treating TMJ disorders improve long-term
outcomes relative to pain, dysfunction and
impairment. Although results of
nonrandomized and uncontrolled studies are
promising, further research from controlled
studies comparing artificial implants with
open TMJ reconstruction using tissue grafts is
needed.
There are limited studies evaluating
biofeedback for the treatment of
musculoskeletal pain, including TMJ pain.
One small uncontrolled study reported
positive effects, while a larger randomized
controlled study failed to demonstrate any
treatment effect.
Well-designed randomized, blinded and
placebo-controlled outcome studies published
on craniosacral manipulation for TMJ are not
available. For additional information
regarding manipulation under anesthesia for
TMJ disorders, see the Manipulation Under
Anesthesia medical policy.
While there are some data from several
randomized trials and case series studies that
certain types of passive rehabilitation
techniques may improve jaw mobility early in
recovery in patients who have undergone
temporomandibular joint (TMJ) surgery, or
have lost jaw mobility due to TMJ
derangement or to contracture following
radiation therapy, these studies all included
very small numbers of patients, and did not
provide blinded assessment of outcomes,
long-term follow-up, or information on
optimal treatment protocols.
Further prospective controlled clinical trials
that directly compare LLPS devices to other
treatment modalities are needed.
Information Pertaining to Medical
Necessity Review (When Applicable)
Arthroplasty
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th Edition, 2012,
Temporomandibular Joint Arthroplasty, ACG:
A-0523 (AC).
48
March 2013
Medical Policy Updates
REVISED
Title
Mechanical
Stretching and
CPM Devices
Effective Date
Apr. 1, 2013
Summary of Changes
 Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Coverage Rationale
The use of low-load prolonged-duration
stretch (LLPS) devices such as the
Dynasplint System and continuous passive
motion (CPM) devices is proven for the
treatment of joint contractures of the upper
and lower extremities.
Information for medical necessity review,
when applicable:
Low-load prolonged duration stretch
devices are medically necessary for patients
who meet the following criteria:
 Used in patients in the immediate postoperative phase of joint surgery as an
adjunct to (and not replacement of)
physical therapy to prevent contractures
of the joints of the upper and/or lower
extremities.
The lumbar continuous passive motion
device is unproven.
Clinical evidence is limited to manufacturer
data. There is no scientific evidence in the
published peer-reviewed medical literature
that these devices for patient controlled
therapy are safe or effective.
Static progressive (SP) stretch splint
devices and patient actuated serial stretch
(PASS) devices, such as the ERMI
Extensionater and Flexionater, for the
treatment of joint
contractures of the extremities alone or
combined with standard physical therapy
are unproven.
Clinical evidence is not sufficient to
demonstrate that use of static progressive or
patient actuated devices improves long-term
patient outcomes. Evidence is limited
primarily to short term outcomes and lack of
comparison to other treatment modalities.
Noninvasive
Prenatal
Diagnosis of Fetal
Aneuploidy Using
Cell-Free Fetal
Nucleic Acids in
Maternal Blood
Apr. 1, 2013


Updated description of
services to reflect most
current clinical evidence
and references
Revised coverage
rationale to indicate:
o DNA-based
noninvasive prenatal
tests of fetal
DNA-based noninvasive prenatal tests of
fetal aneuploidy (including, but not limited
to, MaterniT21™ PLUS, verifi™ or
Harmony Prenatal Test™) are proven as
screening tools for trisomy 21 (Down
syndrome), trisomy 18 (Edwards
syndrome) or trisomy 13 (Patau syndrome)
in ANY ONE of the following
circumstances:
49
March 2013
Medical Policy Updates
REVISED
Title
Noninvasive
Prenatal
Diagnosis of Fetal
Aneuploidy Using
Cell-Free Fetal
Nucleic Acids in
Maternal Blood
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
aneuploidy
(including, but not
limited to,
MaterniT21™
PLUS, verifi™ or
Harmony Prenatal
Test™) are proven
as screening tools
for trisomy 21
(Down syndrome),
trisomy 18 (Edwards
syndrome) or
trisomy 13 (Patau
syndrome) in ANY
ONE of the
following
circumstances:
 Maternal age of
35 years or
older at delivery
 Fetal ultrasound
findings
indicating an
increased risk of
aneuploidy
 History of a
prior pregnancy
with a trisomy
 Positive first- or
second-trimester
screening test
results for
aneuploidy
 Parental
balanced
Robertsonian
translocation
with an
increased risk of
fetal trisomy 13
or trisomy 21
o DNA-based
noninvasive prenatal
tests of fetal
aneuploidy (e.g.,
MaterniT21™
PLUS, verifi™ or
Harmony Prenatal
Test™) are
unproven for
pregnant women
who do not meet the
Coverage Rationale
 Maternal age of 35 years or older at
delivery
 Fetal ultrasound findings indicating an
increased risk of aneuploidy
 History of a prior pregnancy with a
trisomy
 Positive first- or second-trimester
screening test results for aneuploidy
 Parental balanced Robertsonian
translocation with an increased risk of
fetal trisomy 13 or trisomy 21.
DNA-based noninvasive prenatal tests of
fetal aneuploidy (e.g., MaterniT21™ PLUS,
verifi™ or Harmony Prenatal Test™) are
unproven for pregnant women who do not
meet the above criteria or women with
multiple gestations.
Further studies are needed to evaluate the use
of these tests in low-risk populations or
women with multiple gestations.
Genetic Counseling
Genetic counseling is strongly recommended
prior to this test in order to inform persons
being tested about the advantages and
limitations of the test as applied to a unique
person.
Information Pertaining to Medical
Necessity Review (When Applicable)
The above criteria apply to medical necessity
review.
50
March 2013
Medical Policy Updates
REVISED
Title
Noninvasive
Prenatal
Diagnosis of Fetal
Aneuploidy Using
Cell-Free Fetal
Nucleic Acids in
Maternal Blood
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
above criteria or
women with
multiple gestations
 Updated list of applicable
CPT codes; added 81479
and 81599 (new codes
effective 1/1/13)
 Added list of applicable
ICD-9 diagnosis codes:
655.10, 655.11, 655.13,
758.5, 659.50, 659.53,
659.60, 659.63, V23.81
and V23.82
 Added list of applicable
ICD-10 diagnosis codes
(preview draft effective
10/01/14)
Coverage Rationale
Non-Surgical
Treatment of
Obstructive Sleep
Apnea
Apr. 1, 2013

Removable oral appliances are proven for
treating obstructive sleep apnea (OSA) as
documented by polysomnography. Refer to
the Medical Policy titled Polysomnography
and Portable Monitoring for Sleep Related
Breathing Disorders for further information.
Revised coverage
rationale:
o Added information
pertaining to medical
necessity review
(when applicable)
o Replaced references
to “Milliman Care
Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th
edition, 2013”
(effective 04/01/13)
Removable oral appliances are unproven
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 (e.g., Provent®) are
unproven 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 longterm effectiveness and to determine which
patients would benefit from this therapy.
Information Pertaining to Medical
Necessity Review (When Applicable)
Oral appliances
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th Edition, 2012, Oral
51
March 2013
Medical Policy Updates
REVISED
Title
Non-Surgical
Treatment of
Obstructive Sleep
Apnea
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Appliances (Mandibular Advancement
Devices), ACG: A-0341 (AC).
Outpatient
Cardiovascular
Telemetry
Apr. 1, 2013

Revised coverage
rationale; added language
to indicate outpatient
cardiovascular telemetry
is proven for the
following indications:
o Suspected cardiac
arrhythmia not
detected with
standard cardiac
event monitoring
o Cryptogenic stroke
with suspected
occult atrial
fibrillation as the
cause of the stroke
o Monitoring
arrhythmia status
following an
ablation procedure
Updated list of applicable
(proven) ICD-9 diagnosis
codes; added 426.0,
426.10, 426.11, 426.12,
426.13, 426.2, 426.3,
426.4, 426.50, 426.51,
426.52, 426.53, 426.54,
426.6, 426.7, 426.81,
426.82, 426.89, 426.9,
427.0, 427.1, 427.2,
427.31, 427.32, 427.60,
427.61, 427.69, 427.81,
427.89, 427.9, 434.01,
434.11, 434.91, 780.2,
780.4, 785.0, 785.1,
V12.54 and V15.1
Outpatient cardiovascular telemetry is
proven for the following indications:
Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Updated list of applicable
HCPCS codes; added
A8000, A8001 and
Cranial orthotic devices are reconstructive
for the treatment of craniofacial
asymmetry in infants 3-18 months of age
with severe nonsynostotic positional
plagiocephaly or craniosynostosis following
surgical correction.
Severe plagiocephaly is defined as an
asymmetry of 10 mm or more in one of the
following anthropometric measures: cranial

Plagiocephaly and
Craniosynostosis
Apr. 1, 2013





Suspected cardiac arrhythmia not
detected with standard cardiac event
monitoring
Cryptogenic stroke with suspected
occult atrial fibrillation as the cause
of the stroke
Monitoring arrhythmia status
following an ablation procedure
Information Pertaining to Medical
Necessity Review (When Applicable)
The above criteria apply to medical necessity
review.
52
March 2013
Medical Policy Updates
REVISED
Title
Plagiocephaly and
Craniosynostosis
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
A8002
Coverage Rationale
vault, skull base, or orbitotragial depth; OR a
cephalic index at least two standard deviations
above or below the mean for the appropriate
gender/age. Clinical evidence demonstrates
improved surgical outcomes with the postoperative use of the orthotic device. See
Information Pertaining to Medical Necessity
Review (when applicable).
Cranial orthotic devices are cosmetic in
infants with mild to moderate
plagiocephaly.
There are no definitive data demonstrating
that there are adverse health effects associated
with a mild to moderate degree of cranial
asymmetry, and, therefore, it is unclear
whether treatment of these individuals
provides a future health benefit, or merely a
cosmetic effect. In general, severe
plagiocephaly occurs in utero and is present at
birth. Limited clinical evidence suggests that
it may be associated with future ocular and/or
oral abnormalities. Acquired plagiocephaly
occurs following the placement of the infant
in a supine sleeping position to prevent
sudden infant death syndrome, and is
ordinarily mild to moderate. Positional
plagiocephaly has not been linked to future
comorbidities.
Surgical treatment to repair
craniosynostosis is reconstructive
irrespective of the approach used.
Less invasive procedures including
endoscopic strip craniectomy and springmediated cranioplasty are proven nonpreferentially as a form of surgical
treatment to repair craniosynostosis.
Information Pertaining to Medical
Necessity Review (when applicable):
Cranial orthotic devices are medically
necessary when ALL of the following criteria
are met:
 Infant is 18 months of age or younger
 Severe asymmetry is present with or
without torticollis
 Lack of substantial improvement
following conservative therapy of at least
2 months duration with cranial
repositioning and stretching therapy.
53
March 2013
Medical Policy Updates
REVISED
Title
Plagiocephaly and
Craniosynostosis
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
There is evidence that cranial orthotic devices
are effective in reducing the degree of
craniofacial asymmetry in most infants less
than 18 months of age who have
nonsynostotic positional plagiocephaly.
Proton Beam
Radiation
Therapy
Apr. 1, 2013

Proton beam radiation therapy is proven
for the treatment of intracranial
arteriovenous malformations (AVMs) and
melanoma of the uveal tract (includes the
iris, ciliary body and choroid).
Revised coverage
rationale:
o Added information
pertaining to medical
necessity review
(when applicable)
o Replaced references
to “Milliman Care
Guidelines®, 16th
edition, 2012” with
“MCG™ care
guidelines, 17th
edition, 2013”
(effective 04/01/13)
Proton beam radiation therapy is proven
non-preferentially as one form of external
beam radiation therapy for the treatment
of:
 Primary intracranial and skull base
tumors
 Spinal cord tumors
 Prostate cancer
Clinical evidence comparing proton beam
radiation with other forms of external beam
radiation, such as intensity modulated
radiation therapy (IMRT), for treating
intracranial and skull base tumors, spinal cord
tumors and prostate cancer is
limited. Therefore, it is not possible to draw
meaningful conclusions about comparative
effectiveness or adverse events among the
various types of external beam radiation.
Proton beam radiation therapy is unproven
for the treatment of other indications,
including but not limited to:
 Age-related macular degeneration (AMD)
 Bladder cancer
 Cancer of the uterine cervix
 Choroidal hemangioma
 Esophageal cancer
 Hepatocellular carcinoma
 Non-small-cell lung cancer
 Tumors of the vestibular system
 Intracranial and skull base tumors that
have metastasized from another primary
site
It is not known whether the higher precision
of PBT actually translates to better clinical
outcomes than other types of radiation
treatment of many common cancers. There is
54
March 2013
Medical Policy Updates
REVISED
Title
Proton Beam
Radiation
Therapy
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
limited clinical evidence that directly
compares PBT with other types of radiation
therapy. Comparative effectiveness studies
including randomized controlled trials are
needed to document the theoretical
incremental advantages of particle beam
therapy over other radiotherapies (e.g., IMRT,
conventional radiotherapy or stereotactic
photon radiosurgery) in many cancers. Current
published evidence does not allow for any
definitive conclusions about the comparative
effectiveness of these various forms of
external beam radiation.
Proton beam radiation therapy used in
conjunction with intensity-modulated
radiation therapy (IMRT) is unproven.
Clinical evidence is insufficient to support the
combined use of these technologies in a single
treatment plan. Comparative effectiveness
studies including randomized controlled trials
are needed to demonstrate the safety and longterm efficacy of combined therapy.
Information Pertaining to Medical
Necessity Review (When Applicable)
Proton beam radiation therapy is medically
necessary for the following indications:
 intracranial arteriovenous malformations
(AVMs)
 melanoma of the uveal tract (includes the
iris, ciliary body and choroid)
Proton beam radiation therapy is not
medically necessary for non-preferential
indications.
Radiofrequency
Therapy and
Tibial Nerve
Stimulation for
Urinary Disorders
Apr. 1, 2013

Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Percutaneous tibial nerve stimulation is
proven for the treatment of overactive
bladder syndrome including urinary
frequency, urgency, and urge incontinence.
Transurethral radiofrequency energy
therapy (Renessa® System) is unproven for
the treatment of urinary incontinence.
There is insufficient evidence to conclude that
transurethral radiofrequency therapy is
effective for treating urinary incontinence.
Analysis and interpretation of published study
results are complicated by a high placebo
response rate and by the single-blind design of
the trials. Further studies incorporating
blinded assessment of objective outcomes and
55
March 2013
Medical Policy Updates
REVISED
Title
Radiofrequency
Therapy and
Tibial Nerve
Stimulation for
Urinary Disorders
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
longer follow-up are needed, both to confirm
the efficacy and safety of this procedure and
to define the patients who are likely to benefit
from this procedure.
Transvaginal radiofrequency energy
therapy is unproven for the treatment of
urinary incontinence.
There is insufficient evidence to conclude that
transvaginal radiofrequency therapy is
effective for treating urinary incontinence.
Studies report low cure rates and high rates of
additional corrective treatment.
Information Pertaining to Medical
Necessity Review (When Applicable)
Percutaneous tibial nerve stimulation is
medically necessary for the treatment of
urinary frequency, urgency, and urge
incontinence in adult patients refractory to
standard first-line treatment with
pharmacotherapy, when anatomical
abnormalities of the lower urinary tract and
active urinary tract infections are excluded.
Shoulder
Replacement
Surgery
(Arthroplasty)
Surgical
Treatment for
Spine Pain
Apr. 1, 2013
Apr. 1, 2013


Revised coverage
rationale; replaced
references to “Milliman
Care Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th edition,
2013” (effective
04/01/13)
For information regarding medical necessity
review, when applicable, see MCG™ Care
Guidelines, 17th edition, 2013, Shoulder
Arthroplasty, S-634 (ISC).
Revised coverage
rationale:
o Added language to
indicate spinal
fusion using extreme
lateral interbody
fusion (XLIF) or
direct lateral
interbody fusion
(DLIF) are proven
o Added coding
clarification
language:
 The North
American Spine
Society (NASS)
recommends
Spinal fusion using extreme lateral
interbody fusion (XLIF) or direct lateral
interbody fusion (DLIF) is proven.
For information regarding medical necessity
review, when applicable, see MCG™ Care
Guidelines, 17th edition, 2013, Shoulder
Hemiarthroplasty, S-633 (ISC).
Coding Clarification
The North American Spine Society (NASS)
recommends that anterior or anterolateral
approach techniques performed via an open
approach should be billed with CPT codes
22554 – 22585. These codes should be used
to report the use of extreme lateral interbody
fusion (XLIF) and direct lateral interbody
fusion (DLIF) procedures (NASS, 2010).
Laparoscopic approaches should be billed
with an unlisted procedure code.
For information regarding medical necessity
56
March 2013
Medical Policy Updates
REVISED
Title
Surgical
Treatment for
Spine Pain
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
that anterior or
anterolateral
approach
techniques
performed via
an open
approach should
be billed with
CPT codes
22554 – 22585;
these codes
should be used
to report the use
of extreme
lateral interbody
fusion (XLIF)
and direct lateral
interbody fusion
(DLIF)
procedures
(NASS, 2010)
 Laparoscopic
approaches
should be billed
with an unlisted
procedure code
o Replaced references
to “Milliman Care
Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th
edition, 2013”
(effective 04/01/13)
 Updated list of applicable
CPT codes; added
22586, 63265, 63267,
63268, 63270, 63271,
63272, 63286, 63300,
63301, 63302, 63303,
63304, 63305, 63306,
63307 and 63308
 Updated list of applicable
(unproven) CPT codes;
added 0309T
 Updated list of applicable
ICD-10 diagnosis codes
(preview draft effective
10/01/14); removed
M84.48XA and
M84.68XA
Coverage Rationale
review, when applicable, see the following
Milliman Care Guidelines®, 16th Edition,
2012:
 Cervical Diskectomy or
Microdiskectomy, Foraminotomy,
Laminotomy, S-310 (ISC)
 Lumbar Diskectomy, Foraminotomy, or
Laminotomy S-810 (ISC)
 Cervical Laminectomy S-340 (ISC)
 Lumbar Laminectomy S-830 (ISC)
 Cervical Fusion, Anterior S-320 (ISC)
 Cervical Fusion, Posterior S-330 (ISC)
 Lumbar Fusion S-820 (ISC)
The following spinal procedures are
unproven:
A. Spinal fusion, when performed via
the following methods:
1. Laparoscopic anterior
lumbar interbody fusion
(LALIF)
2. Transforaminal lumbar
interbody fusion which
utilizes only endoscopy
visualization (such as a
percutaneous incision with
video visualization)
3. Axial lumbar interbody
fusion (AxiaLIF)
Interlaminar lumbar
instrumented fusion (for
example ILIF)
This includes interbody cages (for
example PEEK, titanium etc), screws
or devices with any of the above
procedures.
Clinical evidence is limited primarily
to retrospective studies and case
series. Randomized, controlled trials
comparing these procedures to
standard procedures are needed to
determine impact on health outcomes
and long-term efficacy.
B. Spinal Decompression
1. Interspinous process
decompression (IPD)
systems, such as the XSTOP for the treatment of
spinal stenosis
2. Minimally invasive lumbar
57
March 2013
Medical Policy Updates
REVISED
Title
Surgical
Treatment for
Spine Pain
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
decompression (MILD)
Clinical evidence is limited to small,
uncontrolled studies with lack of
blinding and long-term follow-up.
No controlled trials have been
performed to compare the X-STOP
IPD and MILD procedures with
decompressive surgery.
C. Spinal Stabilization
1. Stabilization systems, such
as the Dynesys® Dynamic
Stabilization System or the
DSS Stabilization System
for the treatment of
degenerative
spondylolisthesis
2. Total facet joint
arthroplasty, including
facetectomy, laminectomy,
foraminotomy, vertebral
column fixation,
3. Percutaneous sacral
augmentation (sacroplasty)
with or without a balloon or
bone cement for the
treatment of back pain
Clinical evidence is limited to small,
uncontrolled studies with lack of
blinding and long-term follow-up.
Randomized, controlled trials
comparing these procedures to
standard procedures are needed to
determine impact on health outcomes
and long-term efficacy. The Total
Facet Arthroplasty System™ (TFAS)
has not been approved by the U.S.
Food and Drug Administration
(FDA). A single clinical trial is in
progress, but no results have been
published.
D. Stand-alone facet fusion without an
accompanying decompressive
procedure. This includes procedures
performed with or without bone
grafting and/or the use of posterior
intrafacet implants such as fixation
systems, facet screw systems or antimigration dowels. Clinical evidence
is limited primarily to case series and
58
March 2013
Medical Policy Updates
REVISED
Title
Surgical
Treatment for
Spine Pain
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
nonrandomized studies. Randomized,
controlled trials comparing facet
fusion to standard procedures are
needed to determine impact on health
outcomes and long-term efficacy.
Surgical
Treatment of
Obstructive Sleep
Apnea
Apr. 1, 2013

The following surgical procedures are proven
for treating obstructive sleep apnea as
documented by polysomnography. Refer to
the medical policy titled Polysomnography
and Portable Monitoring for Sleep Related
Breathing Disorders for further information.
Revised coverage
rationale:
o Added information
pertaining to medical
necessity review
(when applicable)
o Replaced references
to “Milliman Care
Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th
edition, 2013”
(effective 04/01/13)



Uvulopalatopharyngoplasty (UPPP)
Maxillomandibular advancement surgery
(MMA)
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).
Radiofrequency ablation of the soft palate
and/or tongue base (e.g., Coblation® or
Somnoplasty™) is proven for treating mild
to moderate obstructive sleep apnea as
documented by polysomnography. Refer to
the medical policy titled Polysomnography
and Portable Monitoring for Sleep Related
Breathing Disorders for further information.
According to the American Academy of Sleep
Medicine (AASM) the diagnosis of OSA is
confirmed if the number of obstructive events†
(apneas, hypopneas + respiratory event related
arousals) on polysomnography (PSG) is
greater than 15 events/hour or greater than
5/hour in a patient who reports any of the
following: unintentional sleep episodes during
wakefulness; daytime sleepiness; unrefreshing
sleep; fatigue; insomnia; waking up breath
holding, gasping or choking; or the bed
partner describing loud snoring, breathing
interruptions or both during the patient’s sleep
(Epstein et al., 2009).
†
The frequency of obstructive events is
reported as an apnea + hypopnea index (AHI)
or respiratory disturbance index (RDI). RDI
has at times been used synonymously with
59
March 2013
Medical Policy Updates
REVISED
Title
Surgical
Treatment of
Obstructive Sleep
Apnea
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
AHI, but at other times has included the total
of apneas, hypopneas and respiratory effort
related arousals (RERAs) per hour of sleep.
When a portable monitor is used that does not
measure sleep, the RDI refers to the number
of apneas plus hypopneas per hour of
recording.
OSA severity is defined as
 Mild for AHI or RDI ≥ 5 and < 15
 Moderate for AHI or RDI ≥ 15 and ≤ 30
 Severe for AHI or RDI > 30/hr
The following surgical procedures are
unproven for treating obstructive sleep
apnea:
 Laser-assisted uvulopalatoplasty (LAUP)
 Palatal implants (e.g., Pillar®)
 Lingual suspension (e.g., AIRvance™
Tongue Suspension (formerly Repose®) also referred to as tongue stabilization,
tongue stitch or tongue fixation
 Transoral robotic surgery (TORS)
There is insufficient evidence to conclude that
laser-assisted uvulopalatoplasty (LAUP)
results in improved AHI or secondary
outcomes. Some studies saw a worsening of
symptoms as well as increased complications.
Results of studies provide preliminary but
inconsistent evidence that palatal implants
benefit patients with mild to moderate OSA.
However, the magnitude of the benefits has
been small; the largest randomized controlled
trial (RCT) found that average OSA worsened
in spite of treatment; and the available studies
involved ≤ 1 year of patient monitoring after
treatment. Additional studies are needed to
determine the role of palatal implants in the
management of OSA
There is insufficient evidence to support the
safety, efficacy and long-term outcomes of
lingual suspension in the treatment of OSA.
The published peer-reviewed medical
literature includes a few small, uncontrolled
studies with short-term follow-up. Large,
controlled studies, with long-term follow-up,
comparing lingual suspension to established
procedures are necessary.
60
March 2013
Medical Policy Updates
REVISED
Title
Surgical
Treatment of
Obstructive Sleep
Apnea
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
There is insufficient evidence to support the
safety, efficacy and long-term outcomes of
transoral robotic surgery (TORS) in the
treatment of OSA. Large, controlled studies,
with long-term follow-up, comparing TORS
to established procedures are necessary.
Information Pertaining to Medical
Necessity Review (When Applicable)
Uvulopalatopharyngoplasty
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th Edition, 2012,
Uvulopalatopharyngoplasty (UPPP), A-0245
(ACG).
Maxillomandibular Osteotomy and
Advancement
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th Edition, 2012,
Maxillomandibular Osteotomy and
Advancement, A-0248 (ACG).
Mandibular Osteotomy
For information regarding medical necessity
review, when applicable, see Milliman Care
Guidelines®, 16th Edition, 2012, Mandibular
Osteotomy, A-0247 (ACG).
Radiofrequency Ablation
In addition to the criteria listed above,
radiofrequency ablation of the soft palate
and/or tongue base (e.g., Coblation® or
Somnoplasty™) is medically necessary for
patients who fail to improve with or cannot
tolerate an adequate trial of continuous
positive airway pressure (CPAP) or another
device, including bi-level positive airway
pressure (BiPAP), auto-titrating positive
airway pressure (APAP) and/or oral
appliances.
Follow-up polysomnography should be
performed following surgery to evaluate
response to treatment (Kushida, 2006;
Ferguson, 2006). Refer to the medical policy
titled Polysomnography and Portable
Monitoring for Sleep Related Breathing
Disorders for further information
61
March 2013
Medical Policy Updates
REVISED
Title
Total Artificial
Heart
Effective Date
Apr. 1, 2013
Summary of Changes
 Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Coverage Rationale
The SynCardia temporary Total Artificial
Heart (formerly known as the
CardioWest™ temporary Total Artificial
Heart) is proven as a bridge to heart
transplantation for patients with end-stage
heart disease who have failed optimal
medical therapy, who have no other
reasonable medical or surgical treatment
options, who are ineligible for other
univentricular or biventricular assist
devices (BiVADs) and who meet all of the
following criteria for heart transplantation:
 Very limited life expectancy
 Presence of biventricular failure and
rapid decompensation
 Absence of irreversible organ
dysfunction
 Unavailability of heart donor and
likelihood that condition will
deteriorate before donor can be
identified
 Body surface area greater than or
equal to 1.7 meters squared and
large-sized heart (>1500 cc) as
measured by chest x-ray. If body
surface area is <1.7 meters squared,
bridging with the TAH may be
possible for patients with
cardiomegaly and sufficient space for
device implantation (i.e., anteriorposterior dimension of 10 cm at T-10
by computed tomography scan.)
The AbioCor Implantable Replacement
Heart is unproven as an alternative to heart
transplantation.
There is limited evidence that the AbioCor
TAH, as a permanent replacement for the
failing heart, improves survival. Welldesigned studies are needed to establish the
safety and efficacy of this device.
Information Pertaining to Medical
Necessity Review (When Applicable)
The above criteria apply to medical necessity
review.
Transcatheter
Heart Valve
Procedures
Apr. 1, 2013

Revised coverage
rationale; added
information pertaining to
medical necessity review
Aortic Valve
Transcatheter aortic heart valve
replacement is proven for patients with
severe, symptomatic aortic stenosis who
62
March 2013
Medical Policy Updates
REVISED
Title
Transcatheter
Heart Valve
Procedures
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
(when applicable)
Coverage Rationale
meet the following criteria:
 Patient is not a candidate for
conventional, open valve replacement
surgery
 Procedure is performed using a U.S. Food
and Drug Administration (FDA)
approved device (e.g. Edwards SAPIEN)
 Procedure is performed according to FDA
approved labeled indications and
contraindications
Pulmonary Valve
Transcatheter pulmonary heart valve
replacement (e.g., Melody®) is unproven.
There is insufficient evidence in the clinical
literature demonstrating the long-term efficacy
and durability of catheter-delivered prosthetic
pulmonary heart valves for treating right
ventricular outflow tract dysfunction.
Mitral Valve
Transcatheter mitral valve leaflet repair
(e.g., MitraClip®) is investigational and
unproven due to lack of U.S. Food and
Drug Administration (FDA) approval.
There is insufficient evidence in the clinical
literature demonstrating the long-term efficacy
of catheter-delivered mitral valve leaflet repair
devices for treating mitral regurgitation.
Further results from prospective, randomized
controlled trials are needed to determine
device durability and the ideal candidates for
the procedure.
Information Pertaining to Medical
Necessity Review (When Applicable)
The above criteria apply to medical necessity
review.
Vagus Nerve
Stimulation
Apr. 1, 2013


Revised coverage
rationale; added
information pertaining to
medical necessity review
(when applicable)
Updated list of applicable
HCPCS codes; added
C1767 and C1778
Vagus nerve stimulation (VNS) is proven
for treating epilepsy in persons without a
history of left or bilateral cervical
vagotomy.
The U.S. Food and Drug Administration
(FDA) identifies a history of left or bilateral
cervical vagotomy as a contraindication to
vagus nerve stimulation.
Vagus nerve stimulation is unproven for
treating all other indications, including the
following:
 Alzheimer's disease
63
March 2013
Medical Policy Updates
REVISED
Title
Vagus Nerve
Stimulation
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
 Anxiety disorder
 Autism
 Back and neck pain
 Bipolar disorder
 Bulimia
 Cerebral palsy
 Chronic pain syndrome
 Cluster headaches
 Depression
 Fibromyalgia
 Heart failure
 Migraines
 Morbid obesity
 Narcolepsy
 Obsessive-compulsive disorder
 Paralysis agitans
 Sleep disorders
 Tourette's syndrome
Available studies on the use of vagus nerve
stimulation for treating severe, major
depression or bipolar disorder refractory to
medical therapy contain methodological flaws
such as lack of control group, small sample
size, potential bias, lack of randomization and
blinding and lack of statistical power analysis.
There is a substantial placebo effect associated
with depression treatments and the lack of
data from prospective randomized controlled
or comparative clinical studies considerably
limits the conclusions that can be drawn from
the available evidence. Furthermore,
preliminary analysis of a randomized
controlled trial did not find a statistically
significant difference between sham and
active VNS. Definitive patient selection
criteria for vagus nerve stimulation (VNS) in
patients with treatment-resistant depression
have not yet been established, and significant
predictors of response have also not been
identified.
Early research has examined the use of vagus
nerve stimulation for additional indications.
However, because of limited studies, small
sample sizes and weak study designs, there is
insufficient data to conclude that vagus nerve
stimulation is safe and/or effective for treating
these indications.
Information Pertaining to Medical
Necessity Review (When Applicable)
64
March 2013
Medical Policy Updates
REVISED
Title
Vagus Nerve
Stimulation
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Vagus nerve stimulation (VNS) is medically
necessary for treating epilepsy in patients with
medically refractory epileptic seizures who
are not surgical candidates or have failed
surgical intervention.
It is an expectation that the physician have
experience and expertise in the use of vagus
nerve stimulation.
Wireless Capsule
Endoscopy
Apr. 1, 2013

Revised coverage
rationale; replaced
references to “Milliman
Care Guidelines®, 16th
edition, 2012” with
“MCG™ Care
Guidelines, 17th edition,
2013” (effective
04/01/13)
Wireless capsule endoscopy (WCE) is
proven for the evaluation of the small
bowel for one or more of the following:
 Patients with gastrointestinal blood loss
and/or iron-deficiency anemia when other
diagnostic methods, such as upper
endoscopy and colonoscopy, have failed
to identify the source of bleeding
 Patients with known Crohn's disease
(regional enteritis) or clinical symptoms
suggestive of Crohn’s disease when
imaging studies and/or upper or lower
gastrointestinal endoscopic examination
fail to reveal the location or extent of the
pathology, AND when treatment
decisions would be affected by the results
of the test
 Patients with clinical symptoms
suggestive of celiac disease when prior
serology or gastrointestinal endoscopy are
not diagnostic
 Patients with suspected small bowel
tumor when imaging studies or
gastrointestinal endoscopic findings have
failed to confirm a tumor
 Surveillance of the small bowel in
patients with Lynch syndrome or
inherited polyposis syndromes such as
familial adenomatous polyposis and
Peutz-Jeghers syndrome
Wireless capsule endoscopy (WCE) is
proven for screening of esophageal varices
when there is an established diagnosis of
cirrhosis and patient is unable to safely
undergo esophagogastroduodenoscopy.
Wireless capsule endoscopy (WCE) of the
esophagus is unproven for all indications
except for esophageal varices screening as
indicated above.
There is no conclusive data showing that
65
March 2013
Medical Policy Updates
REVISED
Title
Wireless Capsule
Endoscopy
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
esophageal wireless capsule endoscopy
(WCE) is as accurate as conventional
endoscopy or whether the results of such
testing changes physician decision-making or
improves health outcomes such as increased
detection of esophageal pathologies such as
gastroesophageal reflux disease (GERD),
Barrett’s esophagus, or esophagitis.
Wireless capsule endoscopy (WCE) is
unproven in patients with specific
contraindications including the presence of
known or suspected intestinal obstruction,
fistulas, or strictures; since these
abnormalities may hinder passage of the
capsule.
Wireless capsule endoscopy (WCE) is
unproven for all other indications not listed
above as proven.
The diagnostic utility and safety of capsule
endoscopy for other indications has not been
established.
The AGILE™ Patency System is unproven
for verification of gastrointestinal patency
prior to capsule endoscopy.
The AGILE Patency System is used to
confirm the safety of subsequent capsule
endoscopy following prior abdominal surgery,
intestinal obstruction or abdominal adhesions,
and in known Crohn's disease affecting the
small bowel. However, to date there are few
published randomized controlled trials
regarding the patency system. Larger,
randomized studies are needed to validate the
role of the patency capsule in preventing
adverse outcomes compared to established
methods of evaluation in patients being
considered for WCE.
For information regarding medical
necessity review, when applicable, see
MCG™ Care Guidelines, 17th edition,
2013, Capsule Endoscopy ACG: A-0134
(AC).
66
March 2013
Drug and Biologics Policy Updates
NEW
Title
Repository
Corticotropin
Injection (H.P.
Acthar Gel)
Effective Date
Apr. 1, 2013
Utilization Review Guidelines
Repository corticotropin injection (H.P. Acthar Gel) is proven for the
treatment of:
1.
Infantile spasm (i.e., West Syndrome)
Additional information to support medical necessity review where
applicable:
Repository corticotropin injection is medically necessary for the treatment
of infantile spasms for up to 4 weeks when all of the following criteria are
met:
A. Diagnosis of infantile spasms (i.e., West Syndrome)
AND
B. Patient is less than 2 years old
AND
C. Repository corticotropin injection dosing for infantile spasm is as
follows:
a. Initial dose: 75 U/m intramuscular (IM) twice daily for 2
weeks.
b. After 2 weeks, dose should be tapered according to the
following schedule: 30 U/m IM in the morning for 3 days; 15
U/m IM in the morning for 3 days; 10 U/m IM in the morning
for 3 days; and 10 U/m IM every other morning for 6 days (3
doses).
2.
Multiple sclerosis (MS), acute exacerbation
Additional information to support medical necessity review where
applicable:
Repository corticotropin injection is medically necessary for treatment of
acute exacerbations of multiple sclerosis for up to 3 weeks when all of the
following criteria are met:
A. Diagnosis of multiple sclerosis with acute exacerbation
AND
B. **History of failure, contraindication, or intolerance to corticosteroids
for treatment of acute exacerbation of multiple sclerosis
AND
C. Repository corticotropin injection dosing for acute exacerbation is as
follows: 80-120 units intramuscular (IM) or subcutaneous (SQ) daily
for 2-3 weeks on a tapering schedule.
3.
Opsoclonus-myoclonus syndrome (i.e., OMS, Kinsbourne Syndrome)
For the proven indications listed below, refer to the medical necessity criteria,
where applicable, at the end of the list:
4.
5.
6.
7.
8.
9.
10.
11.
12.
Ankylosing spondylitis*
Anterior segment inflammation*
Chorioretinitis*
Dermatomyositis, systemic (polymyositis)*
Diffuse posterior uveitis and choroiditis*
Iridocyclitis*
Iritis*
Juvenile idiopathic arthritis*
Keratitis*
67
March 2013
Drug and Biologics Policy Updates
NEW
Title
Repository
Corticotropin
Injection (H.P.
Acthar Gel)
(continued)
Effective Date
Apr. 1, 2013
Utilization Review Guidelines
13. Nephrotic syndrome without uremia of the idiopathic type or that due to
lupus erythematosus*
14. Optic neuritis*
15. Psoriatic arthritis*
16. Rheumatoid arthritis*
17. Sarcoidosis, symptomatic*
18. Serum sickness*
19. Severe erythema multiforme*
20. Stevens-Johnson syndrome*
21. Systemic lupus erythematosus (SLE)*
*Additional information to support medical necessity review where
applicable:
Repository corticotropin injection is medically necessary when all of the
following criteria are met:
A. Proven indication as listed above
AND
B. **History of failure, contraindication, or intolerance to corticosteroids
**The State of New Jersey prohibits requiring failed prior therapy or
intolerance to therapy as a requirement for coverage.
Centers for Medicare and Medicaid Services (CMS):
Medicare does not have a National Coverage Determination (NCD) for H.P.
Acthar (repository corticotropin injection). In general, Medicare covers
outpatient (Part B) drugs that are furnished "incident to" a physician's service
provided that the drugs are not usually self-administered by the patients who
take them. See the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15,
Section 50 Drugs and Biologicals at
http://www.cms.hhs.gov/manuals/Downloads/bp102c15.pdf
Local Coverage Determinations (LCDs) exist for Corticotropin and compliance
with these policies is required where applicable.
(Accessed October 17, 2012)
UPDATED
Title
Oncology
Medication
Clinical Coverage
Effective Date
Apr. 1, 2013
Summary of Changes
 Routine review; no
change to coverage
rationale
 Removed reference link
to policy titled Avastin
(bevacizumab)(retired
11/14/12)
Coverage Rationale
This policy provides parameters for coverage
of injectable oncology medications (J9000 J9999) covered under the medical benefit
based upon the National Comprehensive
Cancer Network (NCCN) Drugs & Biologics
Compendium™. The Compendium lists the
appropriate drugs and biologics for specific
cancers using US Food and Drug
Administration (FDA)-approved disease
indications and specific NCCN panel
recommendations. Each recommendation is
supported by a level of evidence category.
UnitedHealthcare recognizes indications and
68
March 2013
Drug and Biologics Policy Updates
UPDATED
Title
Oncology
Medication
Clinical Coverage
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
uses of injectable oncology medications listed
in the NCCN Drugs and Biologics
Compendium with Categories of Evidence
and Consensus of 1, 2A, and 2B as proven and
Categories of Evidence and Consensus of 3 as
unproven.
UnitedHealthcare will cover all chemotherapy
agents for individuals under the age of 19
years. The majority of pediatric patients
receive treatments on national pediatric
protocols that are quite similar in concept to
the NCCN patient care guidelines.
Additional Information:
The NCCN Clinical Practice Guidelines in
Oncology™ are a comprehensive set of
guidelines documenting patient management
recommendations for the malignancies that
affect about 97% of all patients with cancer.
They also address supportive care issues. The
guidelines are developed and updated by 44
individual panels, composed of more than 800
clinicians and oncology researchers from the
21 NCCN member institutions and their
affiliates.
NCCN Categories of Evidence and
Consensus:
Category 1: The recommendation is based on
high-level evidence (ie, high-powered
randomized clinical trials or meta-analyses),
and the panel has reached uniform consensus
that the recommendation is indicated. In this
context, uniform means near unanimous
positive support with some possible neutral
positions.
Category 2A: The recommendation is based
on lower level evidence, but despite the
absence of higher level studies, there is
uniform consensus that the recommendation is
appropriate. Lower level evidence is
interpreted broadly, and runs the gamut from
phase II to large cohort studies to case series
to individual practitioner experience.
Importantly, in many instances, the
retrospective studies are derived from clinical
experience of treating large numbers of
patients at a member institution, so panel
members have first-hand knowledge of the
data. Inevitably, some recommendations must
address clinical situations for which limited or
69
March 2013
Drug and Biologics Policy Updates
UPDATED
Title
Oncology
Medication
Clinical Coverage
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
no data exist. In these instances the
congruence of experience-based opinions
provides an informed if not confirmed
direction for optimizing patient care. These
recommendations carry the implicit
recognition that they may be superseded as
higher level evidence becomes available or as
outcomes-based information becomes more
prevalent.
Category 2B: The recommendation is based
on lower level evidence, and there is
nonuniform consensus that the
recommendation should be made. In these
instances, because the evidence is not
conclusive, institutions take different
approaches to the management of a particular
clinical scenario. This nonuniform consensus
does not represent a major disagreement,
rather it recognizes that given imperfect
information, institutions may adopt different
approaches. A Category 2B designation
should signal to the user that more than one
approach can be inferred from the existing
data.
Category 3: The recommendation has
engendered a major disagreement among the
panel members. Several circumstances can
cause major disagreements. For example, if
substantial data exist about two interventions
but they have never been directly compared in
a randomized trial, adherents to one set of data
may not accept the interpretation of the other
side's results. Another situation resulting in a
Category 3 designation is when experts
disagree about how trial data can be
generalized. A Category 3 designation alerts
users to a major interpretation issue in the data
and directs them to the manuscript for an
explanation of the controversy.
Remicade
(infliximab)
Apr. 1, 2013

Infliximab is proven for the treatment of:
1. Crohn’s disease in adults and in children
6 years of age and older
2. Ulcerative colitis in adults and in children
6 years of age and older
3. Rheumatoid arthritis
4. Plaque psoriasis
5. Psoriatic arthritis
6. Ankylosing spondylitis
7. Sarcoidosis

Updated list of
applicable ICD-9
diagnosis codes;
removed 714.4
Updated list of
applicable ICD-10
diagnosis codes (preview
draft effective 10/01/14)
Infliximab is unproven for the treatment of:
70
March 2013
Drug and Biologics Policy Updates
UPDATED
Title
Remicade
(infliximab)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
1. Adult-onset Still’s disease
2. Sjogren’s syndrome
3. Graft-vs-host disease
4. Myelodysplastic syndromes
5. Behçet’s disease
6. Noninfectious ocular disease including
uveitis and scleritis
7. Undifferentiated spondyloarthropathy
8. Reiter’s syndrome
9. Hidradenitis suppurativa
10. Wegener’s granulomatosis
11. Juvenile idiopathic arthritis (juvenile
rheumatoid arthritis)
12. Crohn’s disease in children younger than
6 years of age
13. Ulcerative colitis in children younger than
6 years of age
Infliximab is unproven for the treatment of the
above conditions because statistically robust
randomized controlled trials are needed to
address the issue of whether infliximab has
sufficient superiority in clinical efficacy
compared to other available treatments to
justify the inherent clinical risk in the use of a
monoclonal antibody anti-tumor necrosis
factor agent.
Infliximab is unproven for the treatment of
Crohn’s disease and ulcerative colitis in
children under the age of 6 years due to a
paucity of evidence that addresses the safety
and efficacy of infliximab in this population.
Centers for Medicare and Medicaid
Services (CMS): Medicare does not have a
National Coverage Determination (NCD) for
Remicade® (infliximab). In general, Medicare
covers outpatient (Part B) drugs that are
furnished “incident to” a physician’s service
provided that the drugs are not usually selfadministered by the patients who take them.
See the Medicare Benefit Policy Manual (Pub.
100-2), Chapter 15, §50 Drugs and
Biologicals available at
http://www.cms.hhs.gov/manuals/Downloads/
bp102c15.pdf. Local Coverage
Determinations (LCDs) for Remicade® exist
and compliance with these policies is required
where applicable. See the LCDs for Drugs and
Biologicals: Infliximab (Remicade) and
Infliximab (Remicade) (Accessed 06/22/12)
71
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Actemra
(tocilizumab)
Effective Date
Apr. 1, 2013
Summary of Changes
 Updated description of
services to reflect most
current clinical evidence,
FDA information and
references
 Revised coverage
rationale; added
information to support
medical necessity review
 Updated list of applicable
ICD-9 diagnosis codes;
removed 714.4
 Updated list of applicable
ICD-10 diagnosis codes
(preview draft effective
10/01/14)
Coverage Rationale
Tocilizumab is proven for the treatment of:
1.
Rheumatoid arthritis
Additional information to support
medical necessity review where
applicable:
Tocilizumab is medically necessary for
the treatment of rheumatoid arthritis when
both of the following criteria are met:
A. Moderate to severe disease activity
[e.g., swollen, tender joints with
limited range of motion]
AND
B. **Documented treatment failure,
contraindication, or intolerance to
one or more disease modifying antirheumatic drugs (DMARDs) [e.g.,
hydroxychloroquine, leflunomide,
methotrexate, sulfasalazine]
2.
Systemic juvenile idiopathic arthritis
(SJIA)
Additional information to support
medical necessity review where
applicable:
Tocilizumab is medically necessary for
the treatment of systemic juvenile
idiopathic arthritis when both of the
following criteria are met:
A. Moderate to severe disease activity
[e.g., active fever and systemic
features of disease activity (e.g.,
serositis)]
AND
B. **Documented treatment failure,
contraindication, or intolerance to
one or more first line medications
[e.g., non-steroidal anti-inflammatory
drugs (NSAIDs) or corticosteroids]
Centers for Medicare and Medicaid
Services (CMS):
Medicare does not have
a National Coverage Determination (NCD) for
Actemra (tocilizumab). In general, Medicare
covers outpatient (Part B) drugs that are
furnished "incident to" a physician's service
provided that the drugs are not usually selfadministered by the patients who take them.
72
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Actemra
(tocilizumab)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
See the Medicare Benefit Policy Manual (Pub.
100-2), Chapter 15, section 50 Drugs and
Biologicals at
http://www.cms.hhs.gov/manuals/Downloads/
bp102c15.pdf
Local Coverage Determinations (LCDs) do
not exist at this time.
(Accessed December 27, 2012)
Campath
(alemtuzumab)
Apr. 1, 2013



Updated description of
services to reflect most
current clinical evidence
and references
Revised coverage
rationale:
o Added information
to support medical
necessity review for
treatment of
relapsing-remitting
multiple sclerosis
o Added language to
indicate, effective
09/04/12, Campath
is no longer be
available
commercially but
will be provided
through the Campath
Distribution
Program free of
charge; additional
details about this
program may be
found at
www.campath.com
Updated list of applicable
ICD-9 diagnosis codes
(for non-oncology
indications); removed
V42.2, V42.3, V42.4,
V42.5, V42.89 and
V42.9
This drug policy will ONLY be updated for
non-oncology indications. Please refer to the
Oncology Medication Clinical Coverage
Policy for updated information based on the
National Comprehensive Cancer Network
(NCCN) Drugs & Biologics Compendium for
oncology indications.
Alemtuzumab is proven for the treatment of:
1) ** Patients undergoing peripheral blood
stem cell (PBSC) and/or bone marrow
transplantation
2) ** Patients undergoing solid organ
transplantation
3) Relapsing-remitting multiple sclerosis
(RRMS)
Additional information to support medical
necessity review where applicable:
Alemtuzumab is medically necessary for
treatment of relapsing-remitting multiple
sclerosis when all of the following criteria are
met:
A. Diagnosis of relapsing-remitting
multiple sclerosis (RRMS); AND
B. One of the following:
i.
Treatment-naïve to
alemtuzumab:
1. Patient has not been previously
treated with alemtuzumab
AND
2. Patient is not receiving
alemtuzumab in combination
with another disease modifying
agent (e.g., interferon beta
preparations, glatiramer acetate,
natalizumab, fingolimod, or
teriflunomide)
AND
3. Initial dosing is administered: 12
mg intravenously daily for 5
consecutive days
73
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Campath
(alemtuzumab)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
AND
4. Regimen is administered only
once within 12 months
OR
ii.
Treatment-experienced with
alemtuzumab:
1. Patient has previously received
treatment with alemtuzumab
AND
2. Patient is not receiving
alemtuzumab in combination
with another disease modifying
agent (e.g., interferon beta
preparations, glatiramer acetate,
natalizumab, fingolimod, or
teriflunomide)
AND
3. Retreatment dosing is
administered: 12 mg
intravenously daily for 3
consecutive days
AND
4. Regimen is administered only
once within 12 months
** Effective September 4th, 2012, Campath
will no longer be available commercially, but
will be provided through the Campath
Distribution Program free of charge.
Additional details about this program may be
found at www.campath.com.
Alemtuzumab is unproven for the treatment
of:
1) Rheumatoid arthritis
2) Autoimmune neutropenia
3) Autoimmune hemolytic anemia
4) Pure red cell aplasia
5) Immune thrombocytopenic purpura
6) Evans syndrome
7) Autoimmune pancytopenia
Centers for Medicare and Medicaid
Services (CMS): Medicare does not have a
National Coverage Determination (NCD) for
alemtuzumab. Medicare covers outpatient
(Part B) drugs that are furnished “incident to”
a physician’s service provided that the drugs
are not usually self-administered by the
patients who take them. See the Medicare
Benefit Policy Manual (Pub. 100-2), Chapter
15, §50 Drugs and Biologicals at
74
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Campath
(alemtuzumab)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
http://www.cms.hhs.gov/manuals/Downloads/
bp102c15.pdf.
Local Coverage Determinations (LCDs) exist
for alemtuzumab and compliance with these
policies is required where applicable.
See the LCD for Alemtuzumab (Campath)
(Accessed December 19, 2012)
Immune Globulin
(IVIG and SCIG)
Apr. 1, 2013

This policy refers to the following intravenous
immune globulin (IVIG) drug products:





Changed policy title;
previously titled Immune
Globulin (IVIG)
Updated list of applicable
IVIG drug products:
o Added Bivigam™
o Removed
Vivaglobulin
Updated description of
services to reflect most
current clinical evidence
and references; added
FDA Safety
Communication
Reformatted and revised
coverage rationale:
o Added Alzheimer’s
disease to list of
unproven uses
o Added
paraproteinemic
neuropathy to list of
proven uses
(previously
unproven)
o Added medical
necessity criteria
Updated list of applicable
CPT codes; added 90283
and 90284
Updated list of applicable
ICD-9 codes:
o Added 204.12,
242.00, 242.01,
279.11, 279.8, 279.9,
288.09, 288.1,
323.01, 323.02,
323.9, 357.9, 484.1,
646.80, 646.81,
646.82, 646.83,
646.84, 678.00,
678.03, 757.39,
776.8 and 776.9
Bivigam™
Carimune® NF
Flebogamma®
Flebogamma® DIF
Gammagard® Liquid
Gammagard® S/D
Gammaplex®
Gammaked™
Gamunex®
Gamunex®-C
Octagam®
Privigen®
And also to the following subcutaneous
immune globulin (SCIG) drug products:
Gammagard® Liquid
Gammaked™
Gamunex®-C
Hizentra®
The list that follows summarizes the proven
indications for immune globulin. By clicking
on each hyperlink within this list, you will be
directed to the corresponding medical
necessity criteria for that proven indication,
where applicable.
Immune globulin is proven for:
1) Asthma (severe, persistent, high-dose
steroid-dependent)
2) Autoimmune bullous diseases
[pemphigus vulgaris, pemphigus
foliaceus, bullous pemphigoid, mucous
membrane (cicatricial) pemphigoid,
epidermolysis bullosa acquisita,
pemphigoid gestationis, linear IgA
bullous dermatosis]
3) Autoimmune diabetes mellitus
4) Autoimmune uveitis
5) Bone marrow transplantation (BMT),
75
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
o Removed 038.10,
041.01, 242.0,
279.02, 287.33,
337.00, 337.01,
337.09, 356.9,
358.00, 694.0, 714.4,
772.10, 772.11,
772.12, 772.13,
772.14, 776.7,
995.91 and 995.92
 Updated list of applicable
ICD-10 diagnosis codes
(preview draft effective
10/01/14)
Coverage Rationale
prevention of acute graft vs. host disease
(GVHD) after BMT
6) Bone marrow transplantation (BMT),
prevention of infection after BMT
7) Chronic inflammatory demyelinating
polyneuropathy
8) Chronic lymphocytic leukemia
9) Cytomegalovirus (CMV) induced
pneumonitis in solid organ transplants
10) Dermatomyositis or polymyositis
11) Enteroviral meningoencephalitis
12) Fetomaternal alloimmune
thrombocytopenia
13) Graves’ ophthalmopathy
14) Guillain-Barré syndrome (GBS)
15) HIV-infection, prevention of bacterial
infection in pediatric HIV
16) IgM antimyelin-associated glycoprotein
paraprotein-associated peripheral
neuropathy
17) Immune thrombocytopenic purpura (ITP)
18) Kawasaki disease
19) Lambert-Eaton myasthenic syndrome
(LEMS)
20) Lennox Gastaut syndrome
21) Lymphoproliferative disease, bacterial
infections
22) Monoclonal gammopathy
23) Multifocal motor neuropathy (MMN)
24) Multiple sclerosis, relapsing remitting
(RRMS)
25) Myasthenia gravis (MG)
26) Paraproteinemic neuropathy
27) Posttransfusion purpura
28) Primary immunodeficiency syndromes
(list not all inclusive)
A. Autosomal recessive
agammaglobinulinemia
B. Autosomal recessive
hyperimmunoglobulin M syndrome
(HIM)
C. Bruton’s disease
D. Combined immunodeficiency
disorders
1. Ataxia-telangiectasia
2. DiGeorge syndrome
3. Nijmegan breakage syndrome
4. WHIM (warts,
hypogammaglobulinemia,
immunodeficiency, and
myelokathexis) syndrome
5. Wiscott Aldrich syndrome
76
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
E. Common variable immunodeficiency
F. Congenital hypogammaglobulinemia
late onset, ICOS impaired
G. Congenital / X-linked
agammaglobulinemia
H. Good syndrome (immunodeficiency
with thymoma)
I. Hyperimmunoglobulinemia E
syndrome
J. Hypogammaglobulinemia
K. ICF syndrome
L. Selective IgG subclass deficiencies
M. Severe combined immunodeficiency
N. Specific antibody deficiency
O. Transient hypogammaglobulinemia
of infancy, short-term treatment of
recurrent severe bacterial infections
P. X-linked immunodeficiency with
hyperimmunoglobulin M
28) Rasmussen syndrome
29) Renal transplantation, prevention of acute
humoral rejection
30) Renal transplantation, treatment of acute
humoral rejection
31) Rheumatoid arthritis, severe
32) Rotaviral enterocolitis
33) Staphylococcal toxic shock
34) Stiff-person syndrome
35) Toxic epidermal necrolysis or StevensJohnson syndrome
36) Urticaria, delayed pressure
General instructions to support medical
necessity review where applicable:
The information below indicates general precertification requirements for those proven
indications not having specific medical
necessity criteria in the list of proven
indications.
Documentation required:
1.
For initial therapy:
A. Diagnosis
AND
B. Medical records documenting all of
the following:
1. History and physical
examination, documenting the
severity of the condition,
including frequency and severity
of infections
77
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
2. Laboratory results supporting the
diagnosis for which immune
globulin is requested
AND
C. Clinically significant functional
deficiency of humoral immunity
as evidenced by one of the
following:
1. Documented failure to
produce antibodies to
specific antigens
OR
2. History of significant
recurrent infections
2.
For continuation of therapy:
A. Medical records indicating objective
response to therapy, including
decreasing frequency and severity of
infections.
AND
B. Statement of expected frequency and
duration of proposed IVIG treatment
AND
C. Titration to the minimum dose and
frequency to maintain a sustained
clinical effect
AND
D. Serum Immunoglobulin levels prior
to IVIG therapy
Note: Additional documentation may also
be required for specific diagnoses as
noted within each proven indication
below.
Immune globulin is proven for:
1) Asthma (severe, persistent, high-dose
steroid-dependent)
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of severe, persistent, high-dose
steroid-dependent asthma when both of
the following criteria are met:
A. **Patient is receiving optimal
conventional asthma therapy (e.g.,
high-dose inhaled glucocorticoids,
short- and long-acting inhaled β
78
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
agonists)
AND
B. **Patient has required continuous
oral glucocorticoid therapy for a
minimum of 2 months prior to the
decision to initiate IVIG therapy
2) Autoimmune bullous diseases
[pemphigus vulgaris, pemphigus
foliaceus, bullous pemphigoid, mucous
membrane (cicatricial) pemphigoid,
epidermolysis bullosa acquisita,
pemphigoid gestationis, linear IgA
bullous dermatosis]
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of autoimmune bullous diseases
when all of the following criteria are met:
A. Extensive and debilitating disease
AND
B. **Contraindication to, failure of, or
significant side effects from systemic
corticosteroids with concurrent
immunosuppressive treatment (e.g.,
azathioprine, cyclophosphamide,
mycophenolate mofetil)
AND
C. IVIG dose is 1,000 to 2,000 mg/kg
divided into 3 equal doses each given
on 3 consecutive days or 400 mg/kg
per day given over 5 consecutive
days
3) Autoimmune diabetes mellitus
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of autoimmune diabetes
mellitus when both of the following
criteria are met:
A. Patient is newly diagnosed with
insulin dependent (type 1) diabetes
mellitus
AND
B. **Patient is not a candidate for or is
refractory to insulin therapy
79
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
4) Autoimmune uveitis
5) Bone marrow transplantation (BMT),
prevention of acute graft vs. host disease
(GVHD) after BMT
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for
prevention of acute GVHD after BMT
when all of the following criteria are met:
A. Confirmed allogeneic bone marrow
transplant within the last 100 days
AND
B. Documented severe
hypogammaglobulinemia (IgG < 400
mg/dL)
AND
C. IVIG dose is 500 mg/kg once weekly
for the first 90 days of therapy
6) Bone marrow transplantation (BMT),
prevention of infection after BMT
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for
prevention of infection after BMT when
all of the following criteria are met:
A. Confirmed allogeneic bone marrow
transplant within the last 100 days
AND
B. Documented severe
hypogammaglobulinemia (IgG < 400
mg/dL)
AND
C. IVIG dose is 500 mg/kg once weekly
for the first 90 days of therapy
7) Chronic inflammatory demyelinating
polyneuropathy
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of chronic inflammatory
demyelinating polyneuropathy when all
of the following criteria are met:
A. Initial treatment:
1. Progressive symptoms present
80
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
for at least 2 months
AND
2. Physical findings – symptomatic
polyradiculoneuropathy as
indicated by both of the
following:
a. Progressive or relapsing
motor or sensory
impairment of more than
one limb
AND
b. Widespread hyporeflexia or
areflexia
AND
3. Electrophysiologic findings
when any 3 of the following 4
criteria are present:
a. Partial conduction block of
≥ 1 motor nerve
b. Reduced conduction
velocity of ≥ 2 motor nerves
c. Prolonged distal latency of
≥ 2 motor nerves
d. Prolonged F-wave latencies
of ≥ 2 motor nerves or the
absence of F waves
AND
4. All of the following findings
following lumbar puncture:
a. White blood cell count
<10/mm3
b. Elevated CSF protein
AND
5. IVIG dose is 2,000 mg/kg given
over 2 to 5 days
B. Continuation of treatment:
1. Significant improvement in
clinical condition has been
documented by an objective
measurement scale (e.g., Rankin,
Modified Rankin, or MRC scale)
and when applicable, a reduction
in the level of sensory loss
should be noted
AND
2. For long-term treatment,
documentation that the dose has
been periodically reduced or the
treatment withdrawn, and the
effects measured.
8) Chronic lymphocytic leukemia
81
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of chronic lymphocytic
leukemia when all of the following
criteria are met:
A. Diagnosis of chronic lymphocytic
leukemia (CLL)
AND
B. One of the following:
1. Documented
hypogammaglobulinemia (IgG <
500 mg/dL)
2. History of bacterial infection(s)
associated with B-cell CLL
AND
C. IVIG dose is 400 mg/kg
every 3 to 4 weeks
9) Cytomegalovirus (CMV) induced
pneumonitis in solid organ transplants
10) Dermatomyositis or polymyositis
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of dermatomyositis or
polymyositis when all of the following
criteria are met:
A. Diagnosis of dermatomyositis or
polymyositis
AND
B. **History of failure or intolerance to
one of the following:
1. azathioprine
2. corticosteroid therapy
3. cyclophosphamide
4. methotrexate
AND
C. IVIG dose is 2,000 mg/kg given over
2 to 5 days
11) Enteroviral meningoencephalitis
12) Fetomaternal alloimmune
thrombocytopenia
Additional information to support
medical necessity review where
82
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
applicable:
IVIG is medically necessary for the
treatment of fetomaternal alloimmune
thrombocytopenia when all of the
following criteria are met:
A. For pregnant women
1. Diagnosis of fetomaternal
alloimmune thrombocytopenia
AND
2. One or more of the following:
a. Previously affected
pregnancy
b. Family history of the
disease
c. Platelet alloantibodies found
on screening
AND
3. IVIG dose is 1,000 mg/kg for 2
days
OR
B. For newborns
1. Diagnosis of fetomaternal
alloimmune thrombocytopenia
AND
2. Thrombocytopenia that persists
after transfusion of antigennegative compatible platelets
13) Graves’ ophthalmopathy
14) Guillain-Barré syndrome (GBS)
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of Guillain-Barré syndrome
when all of the following criteria are met:
A. Diagnosis of Guillain-Barré
Syndrome
AND
B. Severe disease (i.e., requiring
assistance to walk)
AND
C. Onset of neuropathic symptoms
within the last four weeks
AND
D. IVIG dose is 2,000 mg/kg given over
2 to 5 days
15) HIV-infection, prevention of bacterial
infection in pediatric HIV
83
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
prevention of bacterial infection in
pediatric HIV when all of the following
criteria are met:
A. Diagnosis of HIV disease
AND
B. Patient age ≤ 13 years
AND
C. One of the following criteria:
1. Documented
hypogammaglobulinemia (IgG ≤
400 mg/dL)
OR
2. Functional antibody deficiency
as demonstrated by either poor
specific antibody titers or
recurrent bacterial infections.
AND
D. IVIG dose is 400 mg/kg every 28
days
16) IgM antimyelin-associated glycoprotein
paraprotein-associated peripheral
neuropathy
17) Immune thrombocytopenic purpura (ITP)
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of immune thrombocytopenic
purpura when all of the following criteria
are met:
A. Diagnosis of immune
thrombocytopenic purpura (ITP)
AND
B. Documented platelet count < 50
x 109 / L
AND
C. IVIG dose is within
specific product-specific
range in chart below
Carimune NF
IV: 400 mg/kg daily for
2 to 5 consecutive days.
In acute ITP of
childhood, if an initial
84
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
platelet count response
to the first two doses is
adequate, therapy may
be discontinued after the
second day of the 5 day
course.
In adults and children, if
after induction therapy
the platelet count falls to
less than 30,000/µL
and/or the patient
manifests clinically
significant bleeding, 400
mg/kg of body weight
may be given as a single
infusion. If an adequate
response does not result,
the dose can be increased
to 800 to 1,000 mg/kg of
body weight given as a
single infusion.
Gamimune N
Induction dose: 400
mg/kg IV daily for 5
days OR 1,000 mg/kg
daily for 1 to 2 days
Maintenance dose: In
adults and children with
ITP, if after induction
therapy the platelet count
falls to less than
30,000/mm3 and/or the
patient manifests
clinically significant
bleeding, 400 mg/kg
may be given as a single
infusion. If an adequate
response does not result,
the dose can be increased
to 800 to 1,000 mg/kg
given as a single
infusion.
Gammagard
S/D
IV: 1,000 mg/kg. Up to
three separate doses may
be given on alternate
days if required.
Gammaked
IV: 2,000 mg/kg divided
in two doses of 1,000
85
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
mg/kg given on two
consecutive days OR
into five doses of 400
mg/kg given on five
consecutive days
Gamunex /
Gamunex-C
IV: 2,000 mg/kg divided
in two doses of 1,000
mg/kg given on two
consecutive days OR
into five doses of 400
mg/kg daily given on
five consecutive days
Privigen
IV: 1,000 mg/kg daily
for 2 consecutive days
18) Kawasaki disease
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of Kawasaki disease when both
of the following criteria are met:
A. Diagnosis of Kawasaki disease
AND
B. IVIG dose is 400 mg/kg for five
consecutive days or a single dose of
2,000 mg/kg
19) Lambert-Eaton myasthenic syndrome
(LEMS)
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of Lambert-Eaton myasthenic
syndrome when both of the following
criteria are met:
A. **Documentation that patient has
failed or is unable to tolerate steroids
and other immunosuppressive
treatments (e.g., azathioprine)
AND
B. IVIG dose is 2,000 mg/kg given over
2 to 5 days
20) Lennox Gastaut syndrome
86
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of Lennox Gastaut syndrome
when both of the following criteria are
met:
A. **Documentation that patient has
failed or is unable to tolerate
traditional anti-epileptic
pharmacotherapy (e.g.,
carbamazepine, lamotrigine,
phenytoin, valproic acid)
AND
B. IVIG dose is 400 mg/kg/day for 4 to
5 consecutive days
21) Lymphoproliferative disease, bacterial
infections
22) Monoclonal gammopathy
23) Multifocal motor neuropathy (MMN)
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of multifocal motor neuropathy
when both of the following criteria are
met:
A. Diagnosis of multifocal motor
neuropathy
AND
B. IVIG dose is 2,400 mg/kg given over
2 to 5 days
24) Multiple sclerosis, relapsing remitting
(RRMS)
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of relapsing remitting multiple
sclerosis when all of the following
criteria are met:
A. Initial treatment:
1. Diagnosis of relapsingremitting multiple sclerosis
(RRMS) with at least one
documented relapse within the
87
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
prior 12 months.
NOTE: treatment of any other
type of multiple sclerosis with
IVIG is not supported by clinical
evidence.
AND
2. Medical records documenting a
comprehensive neurological
examination indicating mental
status, cognitive function, motor
and sensory system evaluations,
reflexes, gait analysis, station
and coordination; EDSS Score
and/or designated form. Medical
records must document a
progression (worsening) of the
patient’s clinical status from the
visit prior to the one prompting
the decision to initiate IVIG
therapy.
AND
3. **Documented treatment failure,
contraindication, or intolerance
to standard conventional
therapies [i.e., two of the
following agents: Avonex
(interferon beta-1a), Betaseron
(interferon beta-1b), Copaxone
(glatiramer acetate), Rebif
(interferon beta-1a), Tysabri
(natalizumab), Aubagio
(teriflunomide), or Gilenya
(fingolimod)]
AND
4. Induction, when indicated, is
with a dose of 400 mg/kg daily
for up to five days, followed by
maintenance dose of up to 1,000
mg/kg monthly.
B. Continuation of treatment:
1. Medical records, including
findings of interval examination
including neurological deficits
incurred and EDSS Score.
AND
2. EDSS Score, stable or improved
AND
3. Documentation of decreased
number of relapses since starting
IVIG therapy
AND
4. Diagnosis continues to be the
88
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
relapsing-remitting form of MS
(RRMS) with supporting
evidence of interval examination
documenting changes showing
the neurological deficits
incurred.
25) Myasthenia gravis (MG), acute
exacerbation
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of myasthenic exacerbation
when all of the following criteria are met:
A. Diagnosis of myasthenia gravis
AND
B. Evidence of myasthenic
exacerbation, defined by one of the
following symptoms in the last
month:
1. Difficulty swallowing
2. Acute respiratory failure
3. Major functional disability
responsible for the
discontinuation of physical
activity
AND
C. IVIG dose is 2,000 mg/kg given over
2 to 5 days
NOTE: Evidence does not support the
use of IVIG maintenance therapy for
myasthenia gravis.
26) Paraproteinemic neuropathy
27) Posttransfusion purpura
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of posttransfusion purpura
when both of the following criteria are
met:
A. Diagnosis of posttransfusion purpura
AND
B. IVIG dose is 1,000 mg/kg for 2 days
28) Primary immunodeficiency syndromes
89
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
(list not all inclusive)
A. Autosomal recessive
agammaglobinulinemia
B. Autosomal recessive
hyperimmunoglobulin M syndrome
(HIM)
C. Bruton’s disease
D. Combined immunodeficiency
disorders
1. Ataxia-telangiectasia
2. DiGeorge syndrome
3. Nijmegan breakage syndrome
4. WHIM (warts,
hypogammaglobulinemia,
immunodeficiency, and
myelokathexis) syndrome
5. Wiscott Aldrich syndrome
E. Common variable immunodeficiency
(CVID)
F. Congenital hypogammaglobulinemia
late onset, ICOS impaired
G. Congenital / X-linked
agammaglobulinemia
H. Good syndrome (immunodeficiency
with thymoma)
I. Hyperimmunoglobulinemia E
syndrome
J. Hypogammaglobulinemia
K. ICF syndrome
L. Selective IgG subclass deficiencies
M. Severe combined immunodeficiency
N. Specific antibody deficiency
O. Transient hypogammaglobulinemia
of infancy, short-term treatment of
recurrent severe bacterial infections
P. X-linked immunodeficiency with
hyperimmunoglobulin M
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of primary
immunodeficiency syndromes when
both of the following criteria are
met:
A. Diagnosis of primary
immunodeficiency
AND
B. IVIG dose is within specific
product-specific range in chart
below
90
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Bivigam
IV: 300 to 800 mg/kg
every 3 to 4 weeks
Carimune NF
IV: 400 to 800 mg/kg
every 3 to 4 weeks
Flebogamma /
Flebogamma
DIF
IV: 300 to 600 mg/kg
every 3 to 4 weeks
Gammagard
Liquid
IV: 300 to 600 mg/kg
every 3 to 4 weeks
SC: 1.37 X previous IV
dose divided by number
of weeks between IV
doses
Gammagard
S/D
IV: 300 to 600 mg/kg
every 3 to 4 weeks
Gamimune N
IV: 300 to 600 mg/kg
every 3 to 4 weeks
Gammaked
IV: 300 to 600mg/kg
every 3 to 4 weeks
SC: 1.37 X previous IV
dose divided by number
of weeks between IV
doses
Gammaplex
IV: 300 to 800 mg/kg
every 3 to 4 weeks
Gamunex /
Gamunex-C
IV: 300 to 600 mg/kg
every 3 to 4 weeks
SC: 1.37 X previous IV
dose divided by number
of weeks between IV
doses
Hizentra
SC: 1.53 X previous IV
dose divided by number
of weeks between IV
doses
Octagam
IV: 300 to 600 mg/kg
every 3 to 4 weeks
Privigen
IV: 200 to 800 mg/kg
every 3 to 4 weeks
28) Rasmussen syndrome
91
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of Rasmussen syndrome when
both of the following criteria are met:
A. Documentation that short term
amelioration of encephalitis is
needed prior to definitive surgical
therapy
AND
B. IVIG dose is 2,000 mg/kg given over
2 to 5 days
29) Renal transplantation, prevention of acute
humoral rejection
30) Renal transplantation, treatment of acute
humoral rejection
31) Rheumatoid arthritis, severe
32) Rotaviral enterocolitis
33) Staphylococcal toxic shock
34) Stiff-person syndrome
Additional information to support
medical necessity review where
applicable:
IVIG is medically necessary for the
treatment of stiff-person syndrome when
both of the following criteria are met:
A. **Documentation that patient has
failed or is unable to tolerate
GABAnergic medication (e.g.,
baclofen, benzodiazepines)
AND
B. IVIG dose is 2,000 mg/kg given over
2 to 5 days
35) Toxic epidermal necrolysis or StevensJohnson syndrome
36) Urticaria, delayed pressure
Immune globulin is unproven for:
1) Acquired hemophilia
2) Acute disseminated encephalomyelitis
(ADEM)
92
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
3) Adrenoleukodystrophy
4) Alzheimer’s disease
5) Amyotrophic lateral sclerosis (ALS)
6) Antiphospholipid antibody syndrome
(APS) in pregnancy
7) Asthma, non-steroid dependent
8) Atopic dermatitis
9) Autism spectrum disorders
10) Autoimmune hemolytic anemia
11) Autoimmune liver disease
12) Autoimmune neutropenia
13) Bone marrow transplantation (BMT),
prevention of chronic graft vs. host
disease (GVHD) after BMT
14) Campylobacter species-induced enteritis
15) Cerebral infarctions with
antiphospholipid antibodies
16) Chronic fatigue syndrome
17) Demyelinative brain stem encephalitis
18) Demyelinating neuropathy associated
with monoclonal IgM
19) Dilated cardiomyopathy
20) HIV infection, to reduce viral load
21) HTLV-1-associated myelopathy
22) Idiopathic dysautonomia, acute
23) Inclusion body myositis
24) Isolated IgA deficiency
25) Isolated IgG4 deficiency
26) Lumbosacral or brachial plexitis
27) Myocarditis, acute
28) Neonatal isoimmune hemolytic jaundice
29) Neonatal sepsis, prevention
30) Neonatal sepsis, treatment
31) Opsoclonus myoclonus
32) Paraneoplastic cerebellar degeneration,
sensory neuropathy, or encephalopathy
33) Pediatric autoimmune neuropsychiatric
disorders associated with streptococcal
infections (PANDAS)
34) POEMS syndrome
35) Postinfectious cerebellar ataxia
36) Postoperative sepsis
37) Pseudomembranous colitis
38) Respiratory syncytial virus (RSV) lower
respiratory tract infection
39) Rheumatic fever, acute
40) Sjogren's syndrome
41) Spontaneous recurrent abortions,
prevention
42) Systemic lupus erythematosus
43) Urticaria, chronic
44) Vasculitides and antineutrophil antibody
93
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Immune Globulin
(IVIG and SCIG)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
syndromes
Efficacy for these conditions has not been
described in adequately designed studies. The
available evidence is limited to case reports or
case series, anecdotal reports, and open-label
trials, or the available studies have failed to
demonstrate a positive treatment effect.
Further well-designed studies are needed to
establish the role of IVIG in these conditions.
Centers for Medicare and Medicaid
Services (CMS):
Medicare covers intravenous immune globulin
(IVIG) when criteriais met. See the Medicare
Benefit Policy Manual (Pub. 100-2) Chapter
15 - Section 50.6 Coverage of Intravenous
Immune Globulin for Treatment of Primary
Immune Deficiency Diseases in the Home at
http://www.cms.hhs.gov/manuals/Downloads/
bp102c15.pdf
Medicare covers Intravenous Immune
Globulin when criteria is met. Refer to
the National Coverage Determination (NCD)
for Intravenous Immune Globulin for the
Treatment of Autoimmune Mucocutaneous
Blistering Diseases (250.3)
Local Coverage Determinations (LCDs) exist
for Intravenous Immune Globulin
Immune Globulin Intravenous (IVIG)
Drugs and Biologicals Immune Globulin
Intravenous and compliance with these
policies is required where applicable.
(Accessed September 28, 2012)
Orencia
(abatacept)
Apr. 1, 2013



Updated description of
services to reflect most
current clinical evidence
and references
Revised coverage
rationale; updated
information to support
medical necessity review
Updated list of applicable
ICD-10 diagnosis codes
(preview draft effective
10/01/14)
Abatacept is proven for the treatment of:
1.
2.
Rheumatoid arthritis*
Polyarticular juvenile idiopathic arthritis
(JIA)*
*Additional information to support medical
necessity review where applicable:
Abatacept is medically necessary for the
treatment of rheumatoid arthritis or
polyarticular juvenile idiopathic arthritis when
both of the following criteria are met:
A. Moderate to severe disease activity [e.g.,
94
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Orencia
(abatacept)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
swollen, tender joints with limited range
of motion]
AND
B. **Documented treatment failure,
contraindication, or intolerance to one or
more disease modifying anti-rheumatic
drugs (DMARDs) [e.g.,
hydroxychloroquine, leflunomide,
methotrexate, sulfasalazine]
**The State of New Jersey prohibits requiring
failed prior therapy or intolerance to therapy
as a requirement for coverage.
Abatacept is unproven for the treatment of:
1.
2.
3.
4.
5.
Multiple sclerosis
Systemic lupus erythematosus
Graft versus host disease (GVHD)
Psoriatic arthropathy
Uveitis associated with Behçet’s disease
Centers for Medicare and Medicaid
Services (CMS):
Medicare does not have a National
Coverage Determination (NCD) for abatacept
(Orencia®). In general, Medicare covers
outpatient (Part B) drugs that are furnished
“incident to” a physician’s service provided
that the drugs are not usually selfadministered by the patients who take them.
See the Medicare Benefit Policy Manual (Pub.
100-2), Chapter 15, §50 Drugs and
Biologicals at
http://www.cms.hhs.gov/manuals/Downloads/
bp102c15.pdf
Local Coverage Determinations (LCDs)
for abatacept exist and compliance with these
policies is required where applicable.
(Accessed December 27, 2012)
Xolair
(omalizumab)
Apr. 1, 2013

Revised coverage
rationale; added
information to support
medical necessity review
Omalizumab for subcutaneous use is proven
for adults and adolescents with moderate to
severe persistent asthma who meet ALL of the
following criteria:
1. Age 12 years or older
2. Have a positive skin test or in vitro
reactivity to a perennial aeroallergen
3. Symptoms inadequately controlled with
inhaled corticosteroids
4. Have a baseline plasma immunoglobulin
95
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Xolair
(omalizumab)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
E (IgE) level between 30 and 700 IU/mL
Additional information to support medical
necessity review where applicable:
Omalizumab is medically necessary for
treatment of moderate to severe persistent
asthma when all of the following criteria are
met:
A. Age 12 years or older
AND
B. Moderate to severe persistent
uncontrolled asthma as defined by
one of the following:
1) Daily asthmatic symptoms
2) Daily use of inhaled short-acting
beta2-agonist
3) Exacerbations affect/limit
activity
4) Exacerbations (requiring oral
systemic corticosteroids)  2
times a year
5) Nighttime awakening more than
once per week
6) Forced expiratory volume in one
second (FEV1) or peak
expiratory flow PEF) < 80% of
predicted level
7) Measures of asthma control
indicate uncontrolled asthma
(eg, Asthma Control Test [ACT]
score ≤ 19 )
AND
C. Baseline (pre-omalizumab treatment)
serum total IgE level ≥ 30 IU/mL and
≤ 700 IU/mL
AND
D. Positive skin test or in vitro reactivity
to a perennial aeroallergen
AND
E. Documented failure (eg, emergency
room visit or hospitalization for
asthma exacerbation, need for oral
steroid burst) of at least 3 months to
regular/routine treatment with one of
the following:
1) One combination inhaled
corticosteroid/long-acting beta2agonist product [e.g., Advair
(fluticasone
propionate/salmeterol), Dulera
(mometasone/formoterol),
Symbicort
96
March 2013
Drug and Biologics Policy Updates
REVISED
Title
Xolair
(omalizumab)
(continued)
Effective Date
Apr. 1, 2013
Summary of Changes
Coverage Rationale
(budesonide/formoterol)]
OR
2) Combination therapy including
both of the following:
(a) One inhaled corticosteroid
at the maximum dosage
[e.g., Flovent (fluticasone
propionate), Pulmicort
(budesonide), QVAR
(beclomethasone
dipropionate)]
AND
(b) One long-acting beta2agonist [e.g., Foradil
(formoterol fumarate),
Serevent (salmeterol
xinafoate)]
Omalizumab is unproven in the following:
1. Pediatric patients less than 12 years of
age
2. Seasonal allergic rhinitis
3. Perennial allergic rhinitis
4. Atopic dermatitis
5. Peanut allergy
6. Acute bronchospasm or status
asthmaticus
7. When given outside FDA labeling
parameters
8. Chronic urticaria
Centers for Medicare and Medicaid
Services (CMS):
Medicare does not have a National Coverage
Determination (NCD) for omalizumab
(Xolair). In general, Medicare covers
outpatient (Part B) drugs that are furnished
“incident to” a physician’s service provided
that the drugs are not usually selfadministered by the patients who take them.
See the Medicare Benefit Policy Manual (Pub.
100-2), Chapter 15, §50 Drugs and
Biologicals at
http://www.cms.hhs.gov/manuals/Downloads/
bp102c15.pdf
Local Coverage Determinations (LCDs) exist
for Omalizumab (Xolair) and compliance with
these policies is required where applicable.
(Accessed January 3, 2013)
97
March 2013
Coverage Determination Guideline (CDG) Updates
NEW
Title
Private Duty
Nursing
Effective Date
May 1, 2013
Coverage Rationale
Plan Document Language
Before using this guideline, please check enrollee’s specific plan document and
any federal or state mandates, if applicable.
Refer to enrollee’s plan specific SPD, Plan Documents or State Contractual
Language to determine if the plan has exclusion for Private Duty Nursing. If
the plan has the exclusion for Private Duty Nursing then the services are not
eligible for coverage.
Indications for Coverage
The services being requested must:
1. Be ordered by a primary practitioner (M.D., D.O., P.A. or N.P), after a
face to face evaluation by the physician, licensed or certified physician
assistant or nurse practitioner; and
2. Services should be skilled in nature (please see CDG titled Custodial and
Skilled Services); and
3. Home is a safe environment for the patient based on a home health
assessment and therapies needed for the patient’s medical condition; and
4. Directed by or under the supervision of primary practitioner (M.D., D.O.,
P.A. or N.P); and
5. Be coordinated with the family and providers by a UHC clinical service
team; and
6. The treatment plan with any required form should be submitted with the
request for specific services and equipment*; and
7. Treatment plan should be reviewed by the UHC clinical service team for
progress toward goals periodically (at least every 60 days); and
8. The services are more cost effective (check plan specific documents for
cost effective definition, if not present please do not use this criteria) in the
home or patient residence (not a hospital or a facility that provides skilled
care) than an alternative setting(ongoing monitoring of the cumulative
costs over 6 months should be documented and reviewed); and
9. Services require one or more of the following:
a. Patient’s condition makes him or her homebound (not an allinclusive list)
i. Poor Prognosis for full recovery; or
ii. Risk of Death; or
iii. Imminent risk to health status due to fragility; or
iv. Condition that may deteriorate quickly without
intervention; or
v. Health status or functional status that can be expected to
stabilize or significantly improve with the services
provided;
Note: the requirements above and below may vary for state
specific contracts and for Long Term Products
OR
b.
c.
Patient’s condition plus the geographic distance make it
unreasonable for patient to obtain the needed services in an
outpatient facility, primary practitioner (M.D., D.O., P.A. or N.P)
office; or
Patient is technology dependent; or
98
March 2013
Coverage Determination Guideline (CDG) Updates
NEW
Title
Private Duty
Nursing
(continued)
Effective Date
May 1, 2013
Coverage Rationale
d. Nursing intervention every 2-3 hours; or
e. Services are needed on a continuous basis (this is more than
“intermittent or part-time”) such as suctioning or hemodynamic
monitoring to assure immediate intervention
10. Patients who are birth through age 17 or up to age 21 (varies by state
specific contracts or COC/SPD) must reside with a responsible adult who
is either trained to provide nursing care or is capable of initiating an
identified contingency plan when the scheduled private duty nurse is
unexpectedly unavailable. (The name and relationship to the patient should
be part of the initial request for services); Some plans may require the
caregiver to provide a certain number of hours of care for the patient check
the enrollee’s plan specific documents or the state contract
11. Home health services for custodial care are provided only as mandated by
the state contract. (See member’s plan specific documents for definition of
custodial and skilled care)
12. Recertification by the primary practitioner (M.D., D.O., P.A. or N.P), or
healthcare professional must be submitted at least every 60-120 days (or
more often if requested by UHC and or state contractual language) on the
appropriate form
*An initial assessment form must accompany the original request for
services. A reassessment for certification form must accompany a request
for extension of benefits. See links to forms below.


Request Form: Private Duty Nursing or Shift Care -- Initial Request for
Information
Recertification Form: 90-120 Day Renewal or Recertification for
Private Duty Nursing
Coverage Limitations and Exclusions
1. Services beyond the plan benefits (hours or days).
2. Requested services are excluded in the plan documents or state specific
contracts.
3. Requested services are defined as non-skilled or custodial care in
enrollee/member’s plan specific documents (refer to Custodial and Skilled
CDG and plan specific documents or state contractual language).
4. Services involve payment of family members or non-professional
caregivers for services performed for the member unless required by state
contract.
5. Services when enrollee does not meet criteria for skilled services.
6. Enrollee is no longer eligible for benefits under the plan or state contract.
For ASO plans with SPD language other than fully-insured Generic COC
language
Please refer to the enrollee’s plan specific SPD for coverage.
When a plan or state contract covers private duty nursing in the home but does
not define or describe the criteria for the services this CDG may be considered
and should be applied.
99
March 2013
Coverage Determination Guideline (CDG) Updates
UPDATED
Title
Breast Reduction
Surgery
Effective Date
Apr. 1, 2013
Summary of Changes
 Routine review; no change to coverage rationale
 Added list of applicable ICD-9 diagnosis codes: 611.1
 Added list of applicable ICD-10 diagnosis codes (preview draft effective
10/01/14): N62
Title
Blepharoplasty,
Blepharoptosis,
and Brow Ptosis
Repair
Effective Date
Apr. 1, 2013
Summary of Changes
Note: The following summary of changes has been revised since originally
announced in the February 2013 edition of the Medical Policy Update Bulletin.
Cosmetic and
Reconstructive
Procedures
Apr. 1, 2013
Custodial and
Skilled Care
Services
Apr. 1, 2013
REVISED

Updated list of applicable CPT codes:
o Brow Ptosis Repair: Added 67911
o Strabismus Repair:
 Added note to indicate strabismus repair is considered
reconstructive
 Added 67311, 67312, 67314, 67316, 67318, 67320, 67331, 67332
and 67334
o Canthus Repair and Lid Repair: Added 67950, 67961 and 67966

Revised coverage rationale; added information pertaining to medical
necessity review (when applicable)
Updated list of applicable procedure codes:
Filler Material SQ Injections
o Added 11950, 11951, 11952 and 1954
o Added coding clarification language to indicate:
 Q2026 (Injection Radiesse 0.1ML) is covered when used for
treatment of facial defects due to facial lipidatrophy in persons
with human immunodeficiency virus (HIV) and treatment of
vocal fold insufficiency
 Q2027 (Injection Sculptra 0.1ML) is covered when used for
treatment of facial defects due to facial lipidatrophy in persons
with human immunodeficiency virus (HIV)
 Other uses of these devices may be cosmetic
Miscellaneous Cosmetic and Reconstructive Procedures
o Added 11960, 15780, 17999, 28344, 40500 and 69320






Reorganized policy content
Reformatted/updated list of applicable Products; removed references to
Certificates of Coverage
Added reference link to Utilization Review Guideline titled Durable
Medical Equipment and Related Supplies, Prosthetics and Orthotics
Revised coverage rationale/indications for coverage; added language to
indicate, for care to be covered, the physician must participate in the
development of the plan of care and review of data collected in the home
health agency’s patient assessment in addition to signed order. In addition,
documentation must indicate an ongoing knowledge of any changes in the
patient’s condition, drugs, or other needs and how they are being met
Added definition of mechanical ventilation
100
March 2013
Coverage Determination Guideline (CDG) Updates
REVISED
Title
Gender Identify
Disorder
Treatment (Sex
Transformation)
Effective Date
Apr. 1, 2013
Summary of Changes
 Revised coverage rationale for standard plans:
Plan Document Language
o Removed language indicating sex transformation surgery is also
referred to as intersex surgery
Coverage Limitations and Exclusions
o Added language to clarify thyroid chondroplasty is the removal or
reduction of the Adam's Apple
Related Services
o Updated list of examples of excluded services; added radiologic
procedures

Revised coverage rationale for plans that cover surgical treatment of
gender identity disorder:
Covered Services
o Added language to indicate, in addition to the surgeon fees, the benefit
applies to the services related to the surgery, including, but not limited
to, anesthesia, laboratory testing, pathology, radiologic procedures,
hospital and facility fees, and/or surgical center fees
Genital Surgery and Surgery to Change Specified Secondary Sex
Characteristics Eligibility Qualifications
o Revised eligibility criteria:
 Removed language indicating the Covered Person must complete
at least 12 months of continuous hormone therapy
 Added language to indicate the Covered Person may be required
to complete continuous hormone therapy (for those without
contraindications); in consultation with the patient’s physician,
this should be determined on a case-by-case basis through the
Notification process. Note the following clarifications:
- A biologic female patient that is only requesting a bilateral
mastectomy does not need to complete hormone therapy in
order to qualify for the mastectomy. However,
UnitedHealthcare recommends that the patient complete at
least 3 months of psychotherapy before having the
mastectomy (Note: WPATH Version 6 recommends that the
patient complete 3 months of psychotherapy and/or 3 months
of hormone therapy)
- A biologic male patient that is able to take female hormones
and is considering breast augmentation surgery should take
the female hormones for at least 18 months before being
considered for bilateral breast augmentation since the patient
may achieve adequate breast development without surgery


Revised definition of gender identity disorder
Updated list of applicable CPT codes; added language to indicate 55970 &
55980 (intersex surgery) may be done for congenital defects, genital
anomalies, or as a treatment for gender identity disorder
101
March 2013
Coverage Determination Guideline (CDG) Updates
REVISED
Title
Nutrition
(Including:
Counseling,
Therapy, Enteral
Nutrition, Infant
Formula, Breast
Milk,
Supplements and
Food)
Effective Date
May 1, 2013
Summary of Changes
 Revised coverage rationale:
For plans with language other than fully-insured Generic COC
language
o Added language to clarify guidelines apply to plans that cover enteral
formula
o Added coverage requirements for medical necessity plans
Orthognathic
(Jaw) Surgery
Apr. 1, 2013


Preventive Care
Services
Apr. 1, 2013


Revised coverage rationale:
Indications for Coverage
o Added reference link to CDG titled Dental Exclusion and Accidental
Dental for additional information on covered oral excisions
Criteria for a Coverage Determination as Reconstructive
o Added language to indicate noted criteria applies to medical necessity
plans
Revised definition of post-surgical sequela
Added reference link to Utilization Review Guideline titled Breast Pump
Revised list of applicable procedure codes (effective for dates of service
on or after 4/1/13):
Cervical Cancer Screening, Pap Smear
o Removed January 2003 USPSTF rating for sexually active women (no
age limits)
o Added March 2012 USPSTF rating for all women age 21 to 65 years.
o Updated claims edit criteria; added language to indicate benefit
applies to females age 21 to 65 years (coverage ends on 66th birthday;
no frequency limit)
Colorectal Cancer Screening
o Moved procedure codes 88304 and 88305 from Code Group 2 to
new/separate Code Group 3
o Added claim edit criteria to indicate the procedure codes listed in
Code Group 3 are paid as preventive if:
 Billed with one of the listed diagnosis codes; and
 Billed with one of the procedure codes listed in Code Group 1 or
Code Group 2
Immunizations
o Removed G9141 (code expires 12/31/12)
Screening for Obesity in Adults
o Removed 2003 USPSTF rating
o Added June 2012 USPSTF rating indicating clinicians should offer or
refer patients with a body mass index (BMI) of 30 kg/m2 or higher to
intensive, multicomponent behavioral interventions
o Added diagnosis codes for BMI of 30.0 – 39.0 (V85.30 – V85.39)
Women’s Preventive Health: Breastfeeding Support, Supplies, and
Counseling
o Added V24.1 to list of applicable diagnosis codes
o Updated claim edit criteria; added language to indicate diagnosis code
V24.1 is required for E0603, E0604 and A4281 – A4286
Appendix
o Added Appendix A, USPSTF Grade Definitions
102
March 2013
Coverage Determination Guideline (CDG) Updates
REVISED
Title
Prosthetic Devices
and Wigs
Effective Date
Apr. 1, 2013
Summary of Changes
 Revised coverage rationale/indications for coverage; added language to
indicate the prosthetic must be approved by the Food and Drug
Administration (FDA) and otherwise generally considered to be safe and
effective for the purposes intended and the item must be reasonable and
necessary for the individual patient
Rhinoplasty,
Septoplasty, and
Repair of
Vestibular
Stenosis
Apr. 1, 2013
Note: The following summary of changes has been revised since originally
announced in the February 2013 edition of the Medical Policy Update Bulletin.





Reorganized policy content
Reformatted/updated list of applicable Products; removed references to
Certificates of Coverage
Revised coverage rationale:
Required Documentation
o Clarified requirements related to documentation of chief complaint
and tests that document septal deviation
Criteria for a Coverage Determination as Reconstructive
o Revised guidelines/requirements for septoplasty:
 Updated/expanded requirements for contemporaneous office
notes to include criterion related to the documentation of
recurrent epistaxis secondary to the septal deformity
 Added language to indicate a CT evaluation to determine extent
of disease is the standard of care prior to any sinus procedures if
there are reasons to suspect polyps as the cause for obstruction or
that chronic sinusitis is the result of obstruction
 Replaced criteria requiring “a formal and signed written CT
report documenting the degree of the septal deviation” with “a
formal and signed written CT or MRI report documenting the
degree of the septal deviation”
 Removed language related to cases where the member or
physician has declined a CT scan of the maxillofacialand nasal
region to document septal deviation
o Revised guidelines/requirements for rhinoplasty for a nasal deformity
when a functional impairment exists; added language to clarify
rhinoplasty is considered reconstructive when performed in
conjunction with a covered correction of congenital craniofacial
anomalies including, but not limited to, correction of cleft lip, cleft
palate, or combinations of the two
o Added guidelines/requirements for rhinoplasty and surgical repair of
vestibular stenosis or alar collapse
o Added language to indicate noted criteria applies to medical necessity
plans
Coverage Limitations and Exclusions
o Updated list of cosmetic procedures excluded from coverage; added
rhinoplasty procedures performed to improve appearance
Updated definition of nasal endoscopy; added nasopharyngoscopy to list
of common names
Updated list of applicable CPT codes (miscellaneous); added 30120,
30540, 30545, 30560 and 30620
103
March 2013
Coverage Determination Guideline (CDG) Updates
REVISED
Title
Specialized,
Microprocessor
or Myoelectric
Limbs
Effective Date
Apr. 1, 2013
Summary of Changes
 Reorganized policy content
 Reformatted/updated list of applicable Products; removed references to
Certificates of Coverage
 Revised coverage rationale/indications for coverage
o Removed reference to “C-Leg” as example of computerized and
specialized lower limb prostheses
o Added reference to “i Ottobock C-Leg® Microprocessor Knee
System” as example of high activity knee control frame (L5930)
 Updated list of applicable HCPCS codes (specialized codes); added
L6611, L6646, L6648, L6920, L6930, L6940, L6950, L6960, L6970 and
L7040
Speech Language
Pathology
Services
Apr. 1, 2013

Revised coverage rationale:
o Added information pertaining to medical necessity review (when
applicable)
o Replaced references to “Milliman Care Guidelines®, 16th edition,
2012” with “MCG™ Care Guidelines, 17th edition, 2013” (effective
04/01/13)
o Added language to indicate, when billed alone, swallowing therapy
(92526) will count toward the speech therapy benefit limit, if
applicable
Surgical and
Ablative
Procedures for
Venous
Insufficiency and
Varicose Veins
May 1, 2013


Reorganized policy content
Reformatted/updated list of applicable Products; removed references to
Certificates of Coverage
Revised coverage rationale:
Criteria for a Coverage Determination to be Reconstructive
o Added guidelines for sclerotherapy and stab phlebectomy /ambulatory
phlebectomy
o Added list of investigational treatments not considered to be
medically necessary and therefore are not covered
o Added language to indicate;

The patient's medical record must document the following:
- history and physical findings supporting a diagnosis of
symptomatic varicose veins
- failure of an adequate trial of conservative treatment as
described in the "Indications" section of this LCD
- exclusion of other causes of edema, ulceration and pain in the
limbs
- performance of appropriate tests to confirm the presence and
location of incompetent perforating veins
- location and number of varicosities, level of incompetence of
the vein and the veins involved, and
- necessity of utilizing ultrasound guidance, if used
 The medical record must also include pre-treatment photographs
of the varicose veins for which claims for sclerotherapy are
submitted
Updated list of applicable CPT codes; added 36470 and 36471 (sclerosing
procedures) and corresponding reference link to CDG titled Cosmetic and
Reconstructive Procedures for associated review criteria
Added list of applicable HCPCS codes: S2202 (echosclerotherapy)



104
March 2013
Utilization Review Guideline (URG) Updates
\
NEW
Title
Breast Pumps
Effective Date
Apr. 1, 2013
Utilization Review Guidelines
Some states may mandate coverage for a type of breast pump and that mandate
may vary from the following. Please refer to enrollee’s specific plan
documents for coverage.
Breastfeeding and human milk are the normative standards for infant feeding
and nutrition. The American Academy of Pediatrics recommends exclusive
breastfeeding for about 6 months, followed by continued breastfeeding as
complementary foods are introduced with continuation of breastfeeding for 1
year or longer as mutually desired by mother and infant. Use of a breast pump
may be necessary to establish and maintain expression of milk to meet the
infant’s nutritional needs.
The following policy addresses plans that are currently subject to, or
voluntarily follow, the Health Resources and Services Administration (HRSA)
requirements for coverage of breast pumps, for plan years beginning on or
after August 1, 2012 (please check benefit plan documents for details.)
The health reform law does not require plans and issuers that have a network of
provider to cover preventive care services, including expanded women’s
preventive services, provided by out-of-network providers. If a plan covers outof-network preventive services, the plan or issuer may impose cost-sharing
requirements, unless a state law otherwise requires first-dollar coverage. If a plan
does not cover out-of-network preventive services, then out-of-network
preventive services (including breast pumps rented or purchased out of network)
will not be covered.
Benefits defined under the HRSA requirement include the cost of renting one
breast pump per pregnancy in conjunction with childbirth.
If more than one type of breast pump can meet the enrollee’s needs, benefits
are available only for the most cost effective pump. UnitedHealthcare will
determine the following:

Which pump is the most cost effective

Whether the pump should be purchased or rented

Duration of a rental

Timing of an acquisition
Hospital Grade Breast Pump: Rental Only
Hospital Grade Breast Pumps (heavy duty designed for multiple users), and the
personal use attachment kit, are covered for enrollees who are lactating
mothers when the enrollee obtains the hospital grade breast pump within
the first two months (60 days) following delivery and their infant has one or
more of the following criteria:
1.
2.
Hospitalized newborn infant
Congenital malformations or genetic abnormalities impacting feeding
(e.g., cleft lip and palate, Down’s Syndrome)
Personal Use Double Electric Breast Pump
High quality, personal use double electrical breast pumps have been shown to
105
March 2013
Utilization Review Guideline (URG) Updates
NEW
Title
Breast Pumps
(continued)
Effective Date
Apr. 1, 2013
Utilization Review Guidelines
be as effective as Hospital grade pumps in outpatient settings for breast feeding
females. This includes mothers with maternal infant separation for work or
school and no other identified lactation risk factors.
A personal use double electrical pump may be covered for the enrollee with the
following criteria:
1.
2.
The woman is a lactating mother
Enrollee should obtain the breast pump within one year (365 days) of
delivery
Additional Information about Breastfeeding:
Supporting statement from Surgeon General Call to action: “Because
breastfeeding confers many important health and other benefits, including
psychosocial, economic, and environmental benefits, it is not surprising that
breastfeeding has been recommended by several prominent organizations of
health professionals, among them the American Academy of Pediatrics (AAP),
American Academy of Family Physicians, American College of Obstetricians
and Gynecologists, American College of Nurse- Midwives, American Dietetic
Association, and American Public Health Association, all of which recommend
that most infants in the United States be breastfed for at least 12 months. These
organizations also recommend that for about the first six months, infants be
exclusively breastfed, meaning they should not be given any foods or liquids
other than breast milk, not even water.” The following is a list of items that
encourage breastfeeding:
1.
2.
3.
Appointments for follow-up visits with mother and child
Hospital practices should support discharged mothers open access to
feeding infant
Patient education (verbal and written) includes:
a. Advantages of exclusive breastfeeding
b. Provision of non-commercial materials compliant with the World
Health Organization Code of Marketing Breast Milk Substitutes
c. Anticipatory guidance
i. Engorgement
ii. Signs of adequate intake
iii. Signs of jaundice
iv. Sleep patterns
v. Maternal medication use
vi. Individual feeding patterns
vii. Follow-up and contact information
d. Expressing, pumping, and storage of human milk
e. Information on support for working mothers
f. Contact information for counseling or support groups
REVISED
Title
Chemotherapy
Observation and
Inpatient
Hospitalization
Effective Date
Apr. 1, 2013
Summary of Changes
 Revised utilization guidelines; replaced references to “Milliman Care
Guidelines®, 16th edition, 2012” with “MCG™ Care Guidelines, 17th
edition, 2013” (effective 04/01/13)
106
March 2013
Utilization Review Guideline (URG) Updates
REVISED
Title
Durable Medical
Equipment and
Related Supplies,
Prosthetics and
Orthotics
Effective Date
Apr. 1, 2013
Summary of Changes
 Removed reference link to Utilization Review Guideline titled Wound
Pumps (retired 04/01/13)
 Added reference link to Coverage Determination Guideline titled
Prosthetic Devices and Wigs
 Revised DME, Orthotics and Prosthetics Supplemental Coding Grid
(attachment file); updated list of applicable HCPCS codes:
o Added equipment type categories and corresponding codes for:
 Automatic External Defibrillators
 Intrapulmonary Percussive Ventilation System
 Mechanical In-Exsufflation Devices
 Pneumatic Compression Devices
 Pressure Reducing Support Services Group 2
 Pressure Reducing Support Services Group 3
 Speech Generating Devices
o Wheelchair Options and Accessories: Added sub-categories and
corresponding codes for;
 Other Power Wheelchair Accessories
 Miscellaneous Accessories
o Hospital Beds/Pediatric: Added E0300
o Positive Airway Pressure (PAP) Devices for the Treatment of
Obstructive Sleep Apnea/ Equipment: Added E047
o Power Mobility Devices: Added K0010, K0011, K0012 and K001
o Wheelchairs-Manual (Bases): Added E1220 and E1230
107
March 2013
Medical Policy Update
Bulletin
If you do not contract directly with UnitedHealthcare, and participate in our network through an arrangement in
which we “Lease” a network from some other entity, some of the information provided in this communication may
not apply to you and/or mayimpact you differently. If you have questions regarding any of the information or need
to better understand its impact on you, please contact your local Network Management representative, Physician
Advocate or Hospital & Facility Advocate. If you are not sure who your contact is, please visit
UnitedHealthcareOnline.com > Contact Us > Network Contacts.
MN012­N108
P.O. Box 1459
Minneapolis, MN55440­1459
M49249 5/11
For more information, visit UnitedHealthcareOnline.com