Download Medical Policy Update Bulletin: July 2016

July 2016
medical policy update bulletin
Medical Policy, Drug Policy & Coverage Determination Guideline Updates
UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to
support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice
staff with a simple and predictable administrative experience. The Medical Policy Update Bulletin was developed to share important information
regarding UnitedHealthcare Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) updates.*
*Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law
Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) Updates
Overview
This bulletin provides complete details on UnitedHealthcare Medical
Policy, Drug Policy, and Coverage Determination Guideline (CDG)
updates. The appearance of a service or procedure in this bulletin
indicates only that UnitedHealthcare has recently adopted a new
policy and/or updated, revised, replaced or retired an existing
policy; it does not imply that UnitedHealthcare provides coverage
for the service or procedure. In the event of an inconsistency or
conflict between the information provided in this bulletin and the
posted policy, the provisions of the posted policy will prevail. Note
that most benefit plan documents exclude from benefit coverage
health services identified as investigational or unproven/not
medically necessary. Physicians and other health care professionals
may not seek or collect payment from a member for services not
covered by the applicable benefit plan unless first obtaining the
member’s written consent, acknowledging that the service is not
covered by the benefit plan and that they will be billed directly for
the service.
A complete library of Medical Policies, Drug Policies, and
Coverage Determination Guidelines (CDGs) is available at
UnitedHealthcareOnline.com > Tools & Resources >
Policies, Protocols and Guides > Medical & Drug Policies
and Coverage Determination Guidelines.
Tips for using the Medical Policy Update Bulletin:
2

From the table of contents, click the policy title to be
directed to the corresponding policy update summary.

From the policy updates table, click the policy title to view a
complete copy of a new, updated, or revised policy.
Medical Policy Update Bulletin: July 2016
Policy Update Classifications
New
New clinical coverage criteria and/or documentation review
requirements have been adopted for a service, procedure, test, or
device
Updated
An existing policy has been reviewed and changes have not been made
to the clinical coverage criteria or documentation review requirements;
however, items such as the clinical evidence, FDA information, and/or
list(s) of applicable codes may have been updated
Revised
An existing policy has been reviewed and revisions have been made to
the clinical coverage criteria and/or documentation review requirements
Replaced
An existing policy has been replaced with a new or different policy
Retired
The procedural codes and/or services previously outlined in the policy
are no longer being managed or are considered to be proven/medically
necessary and are therefore not excluded as unproven/not medically
necessary services, unless coverage guidelines or criteria are otherwise
documented in another policy
Note: The absence of a policy does not automatically indicate or imply
coverage. As always, coverage for a service or procedure must be
determined in accordance with the member’s benefit plan and any
applicable federal or state regulatory requirements. Additionally,
UnitedHealthcare reserves the right to review the clinical evidence
supporting the safety and effectiveness of a medical technology prior to
rendering a coverage determination.
Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) Updates
In This Issue
Medical Policy Updates
Page
UPDATED
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Apheresis - Effective Jul. 1, 2016........................................................................................................................................................................ 5
Bronchial Thermoplasty - Effective Jul. 1, 2016 .................................................................................................................................................... 9
Embolization of the Ovarian and Iliac Veins for Pelvic Congestion Syndrome - Effective Aug. 1, 2016 .......................................................................... 9
Fecal DNA Testing - Effective Jul. 1, 2016 .......................................................................................................................................................... 10
Home Traction Therapy - Effective Jul. 1, 2016 .................................................................................................................................................. 10
Light and Laser Therapy for Cutaneous Lesions and Pilonidal Disease - Effective Aug. 1, 2016 ................................................................................. 11
Meniscus Implant and Allograft - Effective Jul. 1, 2016 ........................................................................................................................................ 12
Molecular Profiling to Guide Cancer Treatment - Effective Jul. 1, 2016 ................................................................................................................... 13
Motorized Spinal Traction - Effective Jul. 1, 2016 ................................................................................................................................................ 14
Umbilical Cord Blood Harvesting and Storage for Future Use - Effective Jul. 1, 2016 ............................................................................................... 15
REVISED
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Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes - Effective Aug. 1, 2016 ......................................................................... 15
Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) - Effective Aug. 1, 2016 .................................................................. 17
Mechanical Stretching and Continuous Passive Motion Devices - Effective Aug. 1, 2016 ........................................................................................... 22
Obstructive Sleep Apnea Treatment - Effective Oct. 1, 2016 ................................................................................................................................ 23
Preterm Labor Management - Effective Aug. 1, 2016........................................................................................................................................... 26
Total Knee Replacement Surgery (Arthroplasty) - Effective Sep. 1, 2016 ............................................................................................................... 27
Transcatheter Heart Valve Procedures - Effective Sep. 1, 2016............................................................................................................................. 27
Drug and Biologics Policy Updates
UPDATED
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Benlysta® (Belimumab) - Effective Jul. 1, 2016 .................................................................................................................................................. 30
Oncology Medication Clinical Coverage Policy - Effective Jul. 1, 2016 .................................................................................................................... 30
Repository Corticotropin Injection (H.P. Acthar Gel®) - Effective Jul. 1, 2016 ......................................................................................................... 32
Rituxan® (Rituximab) - Effective Jul. 1, 2016 ..................................................................................................................................................... 34
Soliris® (Eculizumab) - Effective Jul. 1, 2016 ..................................................................................................................................................... 36
Vaccines - Effective Jul. 1, 2016 ....................................................................................................................................................................... 37
REVISED

3
Mifeprex® (Mifepristone, RU-486) - Effective Aug. 1, 2016 ................................................................................................................................... 38
Medical Policy Update Bulletin: July 2016
Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) Updates
In This Issue
Coverage Determination Guideline (CDG) Updates
UPDATED

Breast Reconstruction Post Mastectomy - Effective Sep. 1, 2016 .......................................................................................................................... 40
REVISED
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4
Breast Reduction Surgery - Effective Aug. 1, 2016 .............................................................................................................................................. 42
Cosmetic and Reconstructive Procedures - Effective Sep. 1, 2016 ......................................................................................................................... 45
Pectus Deformity Repair - Effective Sep. 1, 2016 ................................................................................................................................................ 47
Private Duty Nursing Services (PDN) - Effective Aug. 1, 2016 .............................................................................................................................. 48
Preventive Care Services - Effective Oct. 1, 2016 ............................................................................................................................................... 51
Rhinoplasty and Other Nasal Surgeries - Effective Sep. 1, 2016............................................................................................................................ 54
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
UPDATED
Policy Title
Apheresis
5
Effective Date
Jul. 1, 2016
Summary of Changes

Reformatted and reorganized
policy; transferred content to
new template

Updated/clarified coverage
rationale:
o Replaced language indicating
“therapeutic apheresis is
proven and medically
necessary for the listed
diagnoses” with “therapeutic
apheresis is proven and
medically necessary for
treating or managing the
listed conditions/diagnoses”
o Replaced language indicating
“therapeutic apheresis
including plasma exchange,
plasmapheresis, or
photopheresis is unproven
and not medically necessary
for the listed indications”
with “therapeutic apheresis
including plasma exchange,
plasmapheresis, or
photopheresis is unproven
and not medically necessary
for treating or managing the
conditions/diagnoses,
including but not limited to,
those listed”
o Replaced language indicating
“apheresis is first-line
therapy for the listed
conditions” with “apheresis is
first-line therapy when
treating or managing the
listed conditions/diagnoses”
o Replaced language indicating
“apheresis is proven and
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Therapeutic apheresis is proven and medically necessary for treating
or managing the following conditions/diagnoses:

ABO incompatible heart transplantation in children less than 40 months of
age (plasma exchange)

ABO incompatible hematopoietic stem cell and bone marrow transplant
(plasma exchange)

ABO incompatible kidney transplantation (plasma exchange)

Acute inflammatory demyelinating polyneuropathy (Guillain-Barré
syndrome) (plasma exchange)

ANCA-associated rapidly progressive glomerulonephritis (Wegener’s
Granulomatosis) (plasma exchange)

Anti-glomerular basement membrane disease (Goodpasture’s syndrome)
(plasma exchange)

Babesiosis (RBC exchange)

Cardiac allograft rejection or prophylaxis of cardiac transplant rejection
(photopheresis)

Chronic inflammatory demyelinating polyneuropathy (plasma exchange)

Cryoglobulinemia (plasma exchange)

Cutaneous T-cell lymphoma; mycosis fungoides; Se´zary syndrome,
erythrodermic (photopheresis)

Heterozygous or homozygous familial hypercholesterolemia (plasma
exchange or selective adsorption)

Focal segmental glomerulosclerosis, recurrent (plasma exchange)

Graft-versus-host disease, skin, chronic (photopheresis)

Hyperleukocytosis, leukostasis (leukocytapheresis)

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)
Medical Policy Updates
UPDATED
Policy Title
Apheresis
(continued)
6
Effective Date
Jul. 1, 2016
Summary of Changes
medically necessary for
persons who are refractory
to or intolerant of standard
therapy for the listed
conditions where apheresis is
second-line therapy” with
“apheresis is proven and
medically necessary for
persons who are refractory
to or intolerant of standard
therapy for the listed
conditions/diagnoses where
apheresis is second-line
therapy”

Updated supporting information
to reflect the most current
clinical evidence and references
Medical Policy Update Bulletin: July 2016
Coverage Rationale

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 and not medically necessary for
treating or managing the following conditions/diagnoses, including
but not limited to:

ABO incompatible solid organ transplantation, liver perioperative

Acute disseminated encephalomyelitis

Acute liver failure

Age related macular degeneration

Amyloidosis, systemic

Amyotrophic lateral sclerosis

Aplastic anemia; pure red cell aplasia

Autoimmune hemolytic anemia: warm autoimmune hemolytic anemia;
cold agglutinin disease

Burn shock resuscitation

Catastrophic antiphospholipid syndrome

Chronic focal encephalitis (Rasmussen’s encephalitis)

Coagulation factor inhibitors

Cutaneous T-cell lymphoma; mycosis fungoides; Sézary syndrome, 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

High density lipoprotein (HDL) delipidation and plasma reinfusion

Hyperleukocytosis, prophylaxis

Hypertriglyceridemic pancreatitis

Hyperviscosity in monoclonal gammopathies, prophylaxis for rituximab

IgG/IgA or IgM type of paraproteinemic polyneuropathy treated with
immunoadsorption

Immune thrombocytopenic purpura
Medical Policy Updates
UPDATED
Policy Title
Apheresis
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale

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

POEMS (polyneuropathy, organomegaly, endocrinopathy, M protein, and
skin changes)

Post transfusion purpura

Psoriasis

Red cell alloimmunization in pregnancy

Rheumatoid arthritis, refractory, treated with plasma exchange

Schizophrenia

Scleroderma (progressive systemic sclerosis)

Sepsis with multiorgan failure

Stiff-person syndrome

Systemic lupus erythematosus

Thrombocytosis

Thrombotic microangiopathy: drug-associated

Thrombotic microangiopathy: hematopoietic stem cell 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.
7
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
UPDATED
Policy Title
Apheresis
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale
Apheresis is first-line therapy when treating or managing the
following conditions/diagnoses:

Acute inflammatory demyelinating polyneuropathy (Guillain-Barré
syndrome) (plasma exchange)

ANCA-associated rapidly progressive glomerulonephritis (Wegener’s
Granulomatosis) (plasma exchange)

Anti-glomerular basement membrane disease (Goodpasture’s syndrome)
(plasma exchange)

Babesiosis (RBC exchange)

Cardiac allograft rejection prophylaxis (photopheresis)

Chronic inflammatory demyelinating polyneuropathy (plasma exchange)

Cryoglobulinemia (plasma exchange)

Cutaneous T-cell lymphoma; mycosis fungoides; Se´zary syndrome,
erythrodermic (photopheresis)

Homozygous familial hypercholesterolemia (plasma exchange or selective
adsorption)

Hyperleukocytosis, leukostasis (leukocytapheresis)

Hyperviscosity in monoclonal gammopathies, treatment of symptoms
(plasma exchange)

IgG/IgA, or IgM type of paraproteinemic polyneuropathy (plasma
exchange)

Myasthenia gravis (plasma exchange)

Renal transplantation, antibody mediated rejection (plasma exchange)

Renal transplantation, desensitization, living or deceased donor
recipients, positive crossmatch due to donor specific HLA antibody
(plasma exchange)

Sickle cell disease for one of the following:
o Red blood cell exchange for treating acute stroke or multiorgan
failure
o Prophylaxis with red blood cell exchange for primary or secondary
stroke prevention or for prevention of transfusional iron overload

Thrombotic thrombocytopenic purpura (plasma exchange)
Apheresis is proven and medically necessary for persons who are
refractory to or intolerant of standard therapy for the following
conditions/diagnoses where apheresis is second-line therapy:

ABO incompatible heart transplantation in children less than 40 months of
age (plasma exchange)

ABO incompatible hematopoietic stem cell and bone marrow transplant
8
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
UPDATED
Policy Title
Apheresis
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale
(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)

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)
Bronchial
Thermoplasty
Jul. 1, 2016

Bronchial thermoplasty is unproven and not medically necessary for
treating asthma.
There is insufficient and low quality evidence regarding the use of bronchial
thermoplasty in patients with severe asthma, who are resistant to standard
therapies. Additional well-designed studies are needed to identify the longterm safety and efficacy of bronchial thermoplasty for the treatment of
severe asthma.

Embolization of the
Ovarian and Iliac
Veins for Pelvic
Congestion
Syndrome
July 1, 2016
Aug. 1, 2016*
*Notice of Revision: The following
summary of changes and
corresponding effective date have
been modified. Revisions to the
original policy update announcement
are outlined in red. Please take note
of the amended updates to be
implemented on Aug. 1, 2016.


9
Reformatted and reorganized
policy; transferred content to
new template
Updated supporting information
to reflect the most current
description of services, clinical
evidence, FDA information, and
references; no change to
coverage rationale or list of
applicable codes
Reformatted and reorganized
policy; transferred content to
new template
Updated list of applicable CPT
codes; modified “coding
Medical Policy Update Bulletin: July 2016
Embolization of the ovarian or internal iliac veins is considered
unproven and not medically necessary for treating pelvic congestion
syndrome.
The body of evidence in the peer-reviewed medical literature regarding
embolization of the ovarian or internal iliac veins for the treatment of pelvic
congestion syndrome is insufficient and poor quality. Additional welldesigned randomized controlled trials are necessary to establish the relative
safety and efficacy of the embolization procedure as a treatment of pelvic
congestion syndrome.
Medical Policy Updates
UPDATED
10
Policy Title
Embolization of the
Ovarian and Iliac
Veins for Pelvic
Congestion
Syndrome
(continued)
Effective Date
July 1, 2016
Aug. 1, 2016*
Summary of Changes
clarification” language regarding
the intended use for CPT code
37241:
o Added instruction to see CPT
codes 36468–36479 for
sclerosis of veins or
endovenous ablation of
incompetent extremity veins

Updated list of applicable ICD-9
diagnosis codes (discontinued
Oct. 1, 2015); removed 454.1,
454.2, 454.8 and 459.81

Updated list of applicable ICD-10
diagnosis codes; removed
I83.10–I83.12, I83.201–
I83.205, I83.208, I83.209,
I83.211–I83.215, I83.218,
I83.219, I83.221–I83.225,
I83.228, I83.229, I83.811–
I83.813, I83.819, I83.891–
I83.893, I83.899 and I87.2

Updated supporting information
to reflect the most current FDA
and CMS information and
references
Coverage Rationale
Fecal DNA Testing
Jul. 1, 2016

Updated list of applicable HCPCS
codes to reflect quarterly code
edits (effective Jul. 1, 2016);
removed G0464
Fecal DNA testing for colorectal cancer screening and/or monitoring
is unproven and not medically necessary.
There is insufficient published evidence in the clinical literature supporting the
diagnostic accuracy of fecal DNA tests to screen for colorectal cancer in
asymptomatic, average-risk patients. The gold standard for colorectal cancer
screening is optical colonoscopy. There is insufficient published evidence
comparing fecal DNA testing to optical colonoscopy. In fact, there is
insufficient published clinical evidence that fecal DNA testing reduces the
likelihood of mortality from colorectal cancer.
Home Traction
Therapy
Jul. 1, 2016

Reformatted and reorganized
policy; transferred content to
new template
Home traction therapy is unproven and not medically necessary for
treating low back and neck disorders with or without radiculopathy.
The majority of studies are office based with mixed results. The quality of
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
UPDATED
Policy Title
Home Traction
Therapy
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes

Updated supporting information
to reflect the most current
clinical evidence and references;
no change to coverage rationale
or list of applicable codes
Coverage Rationale
peer reviewed studies for home traction are limited as well to conclude that it
is effective in the management of neck or low back pain or that it improves
health outcomes. The indications for clinical application, patient selection
criteria, risks, and comparison to alternative technologies have not been
established for home traction therapy.
Light and Laser
Therapy for
Cutaneous Lesions
and Pilonidal
Disease
Aug. 1, 2016

Port-Wine Stains and Cutaneous Hemangiomata
Pulsed dye laser therapy is proven and medically necessary for
treating port-wine stains and cutaneous hemangiomata.



Reformatted and reorganized
policy; transferred content to
new template
Updated list of applicable ICD-9
diagnosis codes (discontinued
Oct. 1, 2015); removed 685.0,
685.1, 695.3, and 706.1
Updated list of applicable ICD-10
diagnosis codes:
o Modified table headings;
removed descriptor
classifying codes as “proven”
or “unproven”
o Removed L05.01, L05.02,
L05.91, L05.92, L71.0,
L71.1, L71.8, L71.9, L70.0,
L70.1, L70.3, L70.4, L70.5,
L70.8, L70.9, and L73.0
Updated supporting information
to reflect the most current
description of services, clinical
evidence, CMS information, and
references
Rosacea and Rhinophyma
Light and laser therapy including intense pulsed light are unproven
and not medically necessary for treating rosacea and rhinophyma.
The quantity and quality of the evidence is insufficient to recommend light
and laser treatment for the treatment of rosacea and rhinophyma. The
quality of evidence is limited. Additional research is needed to determine
efficacy and safety and to clarify patient selection and treatment parameters.
Acne Vulgaris
Light and laser therapy including light phototherapy, photodynamic
therapy, intense pulsed light, and pulsed dye laser are unproven and
not medically necessary for treating active acne vulgaris.
There is insufficient evidence to recommend the use of light and laser therapy
for the treatment acne vulgaris. Studies evaluating light and laser therapy for
acne typically are short term, lack controls or the patient serves as their own
control, have small sample sizes, and do not compare laser therapy with
standard acne treatment. Well-designed studies are necessary to clarify the
role of light and laser therapy for acne.
Pilonidal Sinus Disease
Laser hair removal is unproven and not medically necessary for
treating pilonidal sinus disease.
There is insufficient evidence to conclude that laser hair removal is effective
for treating pilonidal sinus disease. Most of the studies regarding this
treatment were small and uncontrolled. Additional well-designed controlled
trials are needed to determine the efficacy of laser hair removal for pilonidal
disease.
11
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
UPDATED
Policy Title
Meniscus Implant
and Allograft
12
Effective Date
Jul. 1, 2016
Summary of Changes

Reformatted and reorganized
policy; transferred content to
new template

Updated/clarified coverage
rationale:
o Replaced language indicating
“meniscus allograft
transplantation with human
cadaver tissue is proven and
medically necessary for
replacement of major
meniscus loss due to trauma
or previous meniscectomy
when all of the listed
indications are present” with
“meniscus allograft
transplantation with human
cadaver tissue is proven and
medically necessary for
replacement of major
meniscus loss due to trauma
or previous meniscectomy
when all of the listed criteria
are met”
o Replaced language indicating
“collagen meniscus implants
are unproven and not
medically necessary for the
treatment of meniscus
injuries or tears” with
“collagen meniscus implants
are unproven and not
medically necessary for
treating or evaluating and
managing meniscus injuries
or tears”

Updated supporting information
to reflect the most current FDA
and CMS information, and
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Meniscus allograft transplantation with human cadaver tissue is
proven and medically necessary for replacement of major meniscus
loss due to trauma or previous meniscectomy when ALL of the
following criteria are met:

Patient who is skeletally mature with documented closure of growth
plates

Patient has significant knee pain and limited function

Patient is missing more than half of the meniscus due to surgery or injury
or has a tear that cannot be repaired

Radiographic criteria established by a standing anteroposterior (AP) view
demonstrates all of the following:
o Normal alignment or correctable varus or valgus deformities
o No osteophytes or marginal osteophytes
o No irreparable articular cartilage defects
o No significant joint space narrowing

Ligamentous stability has been achieved prior to surgery or achieved
concurrently with meniscal transplantation (e.g., concomitant anterior
cruciate ligament surgery)

Documented minimal to absent degenerative changes in surrounding
articular cartilage (Outerbridge Grade II or less)

There is no evidence of active inflammatory arthritis or systemic arthritis

Patient who has failed conservative treatment including physical therapy
and/or bracing techniques.
Collagen meniscus implants are unproven and not medically
necessary for treating or evaluating and managing meniscus injuries
or tears.
There is insufficient evidence that collagen meniscus implants improve health
outcomes such as reduction of symptoms and restoration of knee function in
patients with meniscus injuries or tears. Additional studies with long term
follow-up are needed to determine whether implantation of a collagen
scaffold is able to slow joint degeneration, delay the progression of
osteoarthritis, and reduce pain for long durations.
Medical Policy Updates
UPDATED
Policy Title
Meniscus Implant
and Allograft
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
references
Coverage Rationale
Molecular Profiling
to Guide Cancer
Treatment
Jul. 1, 2016

Molecular profiling using multiplex or next generation sequencing
(NGS) technology is proven and medically necessary for guiding
systemic chemotherapy in patients with metastatic stage IV nonsmall cell lung cancer (NSCLC) when the following criteria are met:

Molecular profiling using multiplex or NGS technology to test for
epidermal growth factor receptor (EGFR) mutations, human epidermal
growth factor receptor 2 (HER2) mutations, RET rearrangements, and
anaplastic lymphoma kinase (ALK) gene arrangements.
o Note: See the National Comprehensive Cancer Network (NCCN)
Clinical Practice Guideline for Non-Small Cell Lung Cancer, available
at: www.nccn.org, for updates regarding oncogenes used in
molecular profile testing for NSCLC. (Accessed April 21, 2016)

The laboratory providing molecular profiling testing services must be
approved by the New York State Department of Health for performing the
molecular profile test.
o Note: See the following website for clinical laboratories holding a
New York State Department of Health permit in the category of
oncology molecular and cellular tumor markers:
http://www.wadsworth.org/labcert/clep/CategoryPermitLinks/Categor
yListing.htm. (Accessed April 21, 2016)

13
Reformatted and reorganized
policy; transferred content to
new template
Updated/clarified coverage
rationale:
o Replaced language indicating
“molecular profiling using
multiplex or next generation
sequencing (NGS)
technology is proven and
medically necessary to guide
systemic chemotherapy in
patients with metastatic
stage IV non-small cell lung
cancer (NSCLC) when used
to test only for epidermal
growth factor receptor
(EGFR) mutations, human
epidermal growth factor
receptor 2 (HER2)
mutations, RET
rearrangements, and
anaplastic lymphoma kinase
(ALK) gene arrangements”
with “molecular profiling
using multiplex or next
generation sequencing
(NGS) technology is proven
and medically necessary for
guiding systemic
chemotherapy in patients
with metastatic stage IV
non-small cell lung cancer
(NSCLC) when used to test
for epidermal growth factor
Medical Policy Update Bulletin: July 2016
Molecular profiling using multiplex or NGS technology is unproven
and not medically necessary for ALL other indications.
There is insufficient evidence in the clinical literature demonstrating that
molecular profiling has a role in clinical decision-making or has a beneficial
effect on health outcomes for other indications. Further studies are needed to
determine the analytic validity, clinical validity and/or clinical utility of
molecular profiling using multiplex or NGS technology for other indications.
Medical Policy Updates
UPDATED
Policy Title
Molecular Profiling
to Guide Cancer
Treatment
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
receptor (EGFR) mutations,
human epidermal growth
factor receptor 2 (HER2)
mutations, RET
rearrangements, and
anaplastic lymphoma kinase
(ALK) gene arrangements”
o Replaced language indicating
“molecular profiling using
multiplex or NGS technology
is unproven and not
medically necessary when
the listed criteria are not
met” with “molecular
profiling using multiplex or
NGS technology is unproven
and not medically necessary
for all other indications [not
listed as proven/medically
necessary]”

Updated definitions:
o Revised definition of “genetic
testing”
o Removed definition of
“molecular profiling”

Updated supporting information
to reflect the most current
clinical evidence, CMS
information, and references
Coverage Rationale
Motorized Spinal
Traction
Jul. 1, 2016

Motorized spinal traction devices are unproven and not medically
necessary for treating neck and low back disorders.
There is insufficient evidence from peer-reviewed published studies to
conclude that spinal unloading devices are effective in the management of
neck or low back pain or that they improve health outcomes. The indications
for use, patient selection criteria, risks, and comparison to alternative
technologies have not been established by the U.S. Food and Drug
Administration (FDA) for Motorized Traction Therapy. (Accessed March 30,
2016)

14
Reformatted and reorganized
policy; transferred content to
new template
Updated coverage rationale;
modified language pertaining to
clinical evidence/study findings
on effectiveness of spinal
unloading devices for the
management of neck or low back
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
UPDATED
Policy Title
Motorized Spinal
Traction
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
pain to clarify the indications for
use, patient selection criteria,
risks, and comparison to
alternative technologies have not
been established by the U.S.
Food and Drug Administration
(FDA) for motorized traction
therapy

Updated supporting information
to reflect the most current
description of services, clinical
evidence, and references
Coverage Rationale
Umbilical Cord
Blood Harvesting
and Storage for
Future Use
Jul. 1, 2016

Collection and storage of umbilical cord blood for possible later use is
unproven and not medically necessary for a person currently healthy
but desiring to provide the opportunity for a hypothetical, future
transplantation.
Published clinical evidence on the use of umbilical cord blood is limited to
diagnosis-specific indications for persons who would otherwise be eligible for
human leukocyte antigen (HLA)-compatible allogeneic bone marrow or stem
cell transplants. Current available clinical evidence does not support the
hypothesis that storage for hypothetical future use improves health
outcomes.


Reformatted and reorganized
policy; transferred content to
new template
Updated benefit considerations;
replaced reference to
“certificate of coverage (COC)”
with “member specific benefit
plan document”
Updated supporting information
to reflect the most current
clinical evidence, CMS
information, and references
For additional information and coverage of umbilical cord blood stem cell
transplantation, please refer to the UnitedHealth Group Transplant Review
Guidelines.
REVISED
Policy Title
Continuous Glucose
Monitoring and
Insulin Delivery for
Managing Diabetes
15
Effective Date
Aug. 1, 2016
Summary of Changes

Reformatted and reorganized
policy; transferred content to
new template

Revised coverage rationale;
updated coverage guidelines for
continuous glucose monitoring:
o Changed service
description/sub-header from
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Insulin Delivery
External insulin pumps that deliver insulin by continuous
subcutaneous infusion are proven and medically necessary for the
following:

Patients with type 1 diabetes
For information regarding medical necessity review, when applicable, see
MCG™ Care Guidelines, 20th edition, 2016, Insulin Infusion Pump
ACG:A-0339 (AC).
Medical Policy Updates
REVISED
Policy Title
Continuous Glucose
Monitoring and
Insulin Delivery for
Managing Diabetes
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
“Continuous Glucose
Monitors with or without
Combined Insulin Pumps” to
“Continuous Glucose
Monitoring”
o Updated coverage criteria for
long-term continuous
glucose monitoring for
personal use at home to
indicate this service is
proven and medically
necessary as a supplement
to self-monitoring of blood
glucose (SMBG) for patients
with type 1 diabetes who
have demonstrated
adherence to a physician
ordered diabetic treatment
plan

Updated supporting information
to reflect the most current
clinical evidence, FDA and CMS
information, and references
Coverage Rationale

Patients with type 2 diabetes who currently perform ≥4 insulin injections
and ≥4 blood glucose measurements daily
Note: Programmable disposable external insulin pumps are considered
equivalent to standard insulin pumps.
Nonprogrammable transdermal insulin delivery systems are
unproven and not medically necessary for treating patients with
diabetes.
There is insufficient evidence in the clinical literature demonstrating the
safety and efficacy of transdermal insulin delivery in the management of
patients with diabetes.
Implantable insulin pumps are investigational, unproven and not
medically necessary.
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 are unproven and not medically necessary 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 these
devices.
See the Description of Services section of the policy for further details on the
various types of insulin delivery systems.
Continuous Glucose Monitoring
Short-term (3-7 days) continuous glucose monitoring by a
healthcare provider for diagnostic purposes is proven and medically
necessary for patients with diabetes.
16
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
REVISED
Policy Title
Continuous Glucose
Monitoring and
Insulin Delivery for
Managing Diabetes
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
Coverage Rationale
Long-term continuous glucose monitoring for personal use at home
is proven and medically necessary as a supplement to selfmonitoring of blood glucose (SMBG) for patients with type 1 diabetes
who have demonstrated adherence to a physician ordered diabetic
treatment plan.
For information regarding medical necessity review, when applicable, see
MCG™ Care Guidelines, 20th edition, 2016, Continuous Glucose Monitoring
ACG:A-0126 (AC).
Long-term continuous glucose monitoring for personal use at home
is unproven and not medically necessary 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 patients with type 2
or gestational diabetes.
Remote Glucose Monitoring
Remote glucose monitoring is unproven and not medically necessary
for managing patients with diabetes.
There is insufficient evidence in the clinical literature to conclude that remote
glucose monitoring demonstrates improvement in clinical outcomes.
Genetic Testing for
Hereditary Breast
and/or Ovarian
Cancer Syndrome
(HBOC)
17
Aug. 1, 2016


Reformatted and reorganized
policy; transferred content to
new template
Revised coverage rationale:
o Updated definitions; added
language to indicate:

A founder mutation is a
gene mutation observed
with high frequency in a
group that is or was
geographically or
culturally isolated, in
which one or more of the
ancestors was a carrier
of the mutant gene; this
phenomenon is often
called a founder effect
Medical Policy Update Bulletin: July 2016
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
c. affected on the same side of the family
d. 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 carcinomas or noninvasive (in situ) ductal carcinoma 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 firstdegree or second-degree female relatives or female relatives surviving
Medical Policy Updates
REVISED
Policy Title
Genetic Testing for
Hereditary Breast
and/or Ovarian
Cancer Syndrome
(HBOC)
(continued)
18
Effective Date
Aug. 1, 2016
Summary of Changes
(National Cancer
Institute web site)
 Updated coverage guidelines
for genetic counseling;
added language to clarify
guidelines apply to benefit
plans that allow for medical
necessity review
o Updated coverage guidelines
BRCA testing:

Modified BRCA testing
criteria pertaining to the
following individuals to
indicate BRCA1 and
BRCA2 testing is proven
and medically necessary
for;
- Women and men
with a personal
history of
pancreatic cancer
at any age and at
least one close blood
relative on the same
side of the family
with ovarian cancer
at any age or breast
cancer (≤ age 50
years), or two
relatives with breast,
pancreatic and/or
prostate cancer
(Gleason score ≥7)
at any age
- Men with a
personal history of
prostate cancer
(Gleason score ≥7)
at any age and at
Medical Policy Update Bulletin: July 2016
Coverage Rationale
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, in the form of a pedigree
drawing/diagram utilizing standardized nomenclature, 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 cancers appearing at the same time
(synchronous) and one is not a metastasis of the other; or primary
cancers developing at different times (metachronous or asynchronous).
The tumors may be in one or two breasts.
8. Gleason scoring is a system of grading prostate cancer tissue based on
how it looks under a microscope. Gleason scores range from 2 to 10 and
indicate how likely it is that a tumor will spread. A low Gleason score
means the cancer tissue is similar to normal prostate tissue and the
tumor is less likely to spread. A high Gleason score means the cancer
tissue is very different from normal and the tumor is more likely to
spread.
9. HBOC-associated malignancies include prostate cancer (Gleason score
≥7), 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 (Gleason score ≥7) 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 (Gleason score ≥7) would not meet criteria because the
aunt and uncle are on different sides of the family.
10. Triple-negative breast cancer refers to any breast cancer that does not
show expression of estrogen receptors (ER), progesterone receptors (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.
11. A founder mutation is a gene mutation observed with high frequency in a
Medical Policy Updates
REVISED
Policy Title
Genetic Testing for
Hereditary Breast
and/or Ovarian
Cancer Syndrome
(HBOC)
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
least one close blood
relative on the same
side of the family
with ovarian cancer
at any age or breast
cancer (≤ age 50
years), or two
relatives with breast,
pancreatic and/or
prostate cancer
(Gleason score ≥7)
at any age

Modified notatation
addressing NCCN testing
guidelines; replaced
references to “unaffected
individual” with
“individual without a
cancer diagnosis”

Updated list of applicable CPT
codes; added 96040

Added list of applicable HCPCS
codes: S0265

Updated supporting information
to reflect the most current
clinical evidence and references
Coverage Rationale
group that is or was geographically or culturally isolated, in which one or
more of the ancestors was a carrier of the mutant gene. This
phenomenon is often called a founder effect (National Cancer Institute
website).
Genetic Counseling
For benefit plans that allow for medical necessity review, genetic counseling
is required by an independent (not employed by a genetic testing lab)
genetics provider prior to genetic testing for BRCA mutations in order to
inform persons being tested about the benefits and limitations of a specific
genetic test as applied to a unique person. Genetics providers employed by
or contracted with a laboratory that are part of an integrated health system
that routinely delivers health care services beyond the laboratory testing
itself are considered independent. Genetic testing for BRCA mutations
requires documentation of medical necessity by one of the following who has
evaluated the member and intends to engage in post-test follow-up
counseling:

Board-Eligible or Board-Certified Genetic Counselor (CGC)

Advanced Genetics Nurse (AGN-BC)

Genetic Clinical Nurse (GCN)

Advanced Practice Nurse in Genetics (APNG)

A Board-Eligible or Board-Certified Clinical Geneticist

A physician with experience in cancer genetics (Defined as providing
cancer risk assessment on a regular basis and having received
specialized ongoing training in cancer genetics. Educational seminars
offered by commercial laboratories about how to perform genetic testing
are not considered adequate training for cancer risk assessment and
genetic counseling.)
Documentation Requirements

Three generation pedigree

UnitedHealthcare genetic counseling attestation form.
BRCA Testing Criteria
Note: National Comprehensive Cancer Network (NCCN) guidelines state that
meeting one or more of these criteria warrants further personalized risk
assessment, genetic counseling and consideration of genetic testing.
Comprehensive BRCA1/BRCA2 genetic testing includes sequencing of both
19
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
REVISED
Policy Title
Genetic Testing for
Hereditary Breast
and/or Ovarian
Cancer Syndrome
(HBOC)
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
Coverage Rationale
BRCA1 and BRCA2 genes and analysis for large genomic rearrangements,
either concurrently or sequentially. NCCN guidelines emphasize the need for
comprehensive testing for individuals who meet the testing criteria for
BRCA1/BRCA2 and have no known familial BRCA1/BRCA2 mutations who
have undergone accurate risk assessment and genetic counseling.
I.
20
Medical Policy Update Bulletin: July 2016
BRCA1 and BRCA2 testing is proven and medically necessary for women
with a personal history of breast cancer in the following situations and
where gene testing results will impact medical management:
A. Breast cancer diagnosed at age 45 or younger with or without family
history; or
B. Breast cancer diagnosed at age 50 or younger with:
1. An additional primary breast cancer; or
2. At least one close blood relative with breast cancer at any age;
or
3. At least one close blood relative with pancreatic cancer; or
4. At least one close blood relative with prostate cancer (Gleason
score ≥7; or
5. An unknown or limited family history (see Definitions section of
the policy for further clarification of limited family history).
C. Breast cancer diagnosed at any age with:
1. At least one close blood relative with breast cancer diagnosed at
age 50 or younger; or
2. At least two close blood relatives on the same side of the family
with breast cancer at any age; or
3. At least one close blood relative with ovarian cancer at any age;
or
4. At least two close blood relatives on the same side of the family
with pancreatic and/or prostate cancer (Gleason score ≥7) at any
age; or
5. Close male blood relative with breast cancer; or
6. At least one close blood relative who has a BRCA1 or BRCA2
mutation (Testing should be targeted to the known
BRCA1/BRCA2 mutation in the family. Further BRCA1/BRCA2
testing should only be pursued if the results are negative and the
patient otherwise meets testing criteria); or
7. Ashkenazi Jewish or ethnic groups associated with founder
mutations. Testing for Ashkenazi Jewish founder-specific
Medical Policy Updates
REVISED
Policy Title
Genetic Testing for
Hereditary Breast
and/or Ovarian
Cancer Syndrome
(HBOC)
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
Coverage Rationale
mutations should be performed first. Further BRCA1/BRCA2
testing should only be pursued if the results are negative and the
patient otherwise meets testing criteria without considering
Ashkenazi Jewish ancestry.
D. Triple-negative breast cancer diagnosed at age 60 or younger.
II.
BRCA1 and BRCA2 testing is proven and medically necessary for women
with a personal history of ovarian cancer.
III. BRCA1 and BRCA2 testing is proven and medically necessary for women
and men with a personal history of pancreatic cancer at any age and at
least one close blood relative on the same side of the family with ovarian
cancer at any age or breast cancer (≤ age 50 years) or two relatives with
breast, pancreatic and/or prostate cancer (Gleason score ≥7) at any
age.
IV. BRCA1 and BRCA2 testing for Ashkenazi Jewish founder-specific
mutations is proven and medically necessary for women and men with a
personal history of pancreatic cancer and Ashkenazi Jewish ancestry.
V. BRCA1 and BRCA2 testing is proven and medically necessary for men
with a personal history of prostate cancer (Gleason score ≥7) at any age
and at least one close blood relative on the same side of the family with
ovarian cancer at any age or breast cancer (≤ age 50 years) or two
relatives with breast, pancreatic and/or prostate cancer (Gleason score
≥7) at any age.
VI. BRCA1 and BRCA2 testing is proven and medically necessary for men
with a personal history of breast cancer.
VII. BRCA1 and BRCA2 screening tests are proven and medically necessary
for men and women without a personal history of breast or ovarian
cancer with at least one of the following familial risk factors only when
there are no family members affected with a BRCA associated cancer
available for testing (see Note below):
A. At least one first- or second-degree blood relative meeting any of
the above criteria (I-VI); or
B. At least one third-degree blood relative with breast cancer and/or
21
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
REVISED
Policy Title
Genetic Testing for
Hereditary Breast
and/or Ovarian
Cancer Syndrome
(HBOC)
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
Coverage Rationale
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 a blood relative (defined as
first-, second- or third-degree relative). Testing should be targeted to
the known BRCA1/BRCA2 mutation in the family. Further
BRCA1/BRCA2 testing should only be pursued if the results are
negative and the patient otherwise meets testing criteria.
Note: NCCN guidelines state that significant limitations of interpreting
test results for an individual without a cancer diagnosis should be
discussed. If there are no living family members with breast or ovarian
cancer available for testing, consider testing family members affected
with other cancers associated with BRCA1/BRCA2, such as prostate
cancer (Gleason score ≥7), pancreatic cancer or melanoma. Testing of
individuals without a cancer diagnosis should only be considered when
there is no affected family member available for testing (NCCN, 2016).
VIII. BRCA1 and/or BRCA2 testing is unproven and not medically necessary
for all other indications including: 1) screening for breast or ovarian
cancer risk for individuals not listed in the proven indications above or
2) for risk assessment of other cancers.
Further evidence is needed to establish the clinical utility of testing in
other populations.
Mechanical
Stretching and
Continuous Passive
Motion Devices
22
Aug. 1, 2016


Reformatted and reorganized
policy; transferred content to
new template
Revised coverage rationale;
updated coverage guideline for
proven/medically necessary use
of low-load prolonged-duration
stretch devices for the treatment
of existing joint contractures of
the upper and lower extremities
as an adjunct to therapy:
 Replaced language requiring
“patient has symptoms of
significant joint motion
Medical Policy Update Bulletin: July 2016
The use of continuous passive motion (CPM) devices is proven for
the prevention of joint contractures of the upper and lower
extremities.
The use of continuous passive motion devices are medically
necessary for patients in the immediate post-operative 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 use of lumbar continuous passive motion device is unproven and
not medically necessary.
Clinical evidence is limited to manufacturer data. There is no scientific
evidence in the published peer-reviewed medical literature that these devices
Medical Policy Updates
REVISED
Policy Title
Mechanical
Stretching and
Continuous Passive
Motion Devices
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
stiffness unresponsive to
other therapies in the
immediate post-operative
period” with “patient has
symptoms of significant joint
motion stiffness in the
immediate post-operative
period”
Coverage Rationale
for patient controlled therapy are safe or effective.
The use of low-load prolonged-duration stretch devices is proven and
medically necessary
for the treatment of existing joint contractures of the upper and
lower extremities as an adjunct to therapy in patients with
symptoms of significant joint motion stiffness in the immediate postoperative period.
The use of static progressive (SP) stretch splint devices and patient
actuated serial stretch (PASS) devices, for the treatment of joint
contractures of the extremities alone or combined with standard
physical therapy are unproven and not medically necessary.
Clinical evidence is not sufficient to demonstrate that use of static
progressive or patient actuated devices is a safe or effective treatment
option. Studies are limited to small sample sizes.
Obstructive Sleep
Apnea Treatment
Oct. 1, 2016



23
Reformatted and reorganized
policy; transferred content to
new template
Updated benefit considerations;
removed language indicating
some benefit plan documents
contain explicit exclusions or
limitations of coverage and/or
allow for the use of patient
selection criteria in determining
coverage
Revised coverage rationale for
surgical treatment:
o Added reference link to the
Coverage Determination
Guideline titled Orthognathic
(Jaw) Surgery for additional
information regarding
medical necessity review for
maxillomandibular
advancement (MMA) surgery
o Revised language pertaining
Medical Policy Update Bulletin: July 2016
Nonsurgical Treatment
Removable oral appliances are proven and medically necessary for
treating obstructive sleep apnea (OSA) as documented by
polysomnography.
Refer to the Medical Policy titled Attended Polysomnography for Evaluation of
Sleep Disorders for further information. For information regarding medical
necessity review, when applicable, see MCG™ Care Guidelines, 20th edition,
2016, Oral Appliances (Mandibular Advancement Devices), A-0341 (ACG).
Removable oral appliances are unproven and not medically
necessary for treating central sleep apnea.
This type of sleep apnea is caused by impaired neurological function, and
these devices are designed to manage physical obstructions.
Nasal dilator devices are unproven and not medically necessary for
treating obstructive sleep apnea (OSA).
There is insufficient clinical evidence supporting the safety and efficacy of
nasal dilators for treating OSA. Results from available studies indicate that
therapeutic response is variable among the participants. Further research
from larger, well-designed studies is needed to evaluate the effectiveness of
the device compared with established treatments for OSA, to determine its
long-term effectiveness and to determine which patients would benefit from
Medical Policy Updates
REVISED
Policy Title
Obstructive Sleep
Apnea Treatment
(continued)
Effective Date
Oct. 1, 2016
Summary of Changes
to radiofrequency ablation of
the soft palate and/or
tongue base to indicate this
procedure is unproven and
not medically necessary for
treating obstructive sleep
apnea

There is insufficient
evidence to support the
efficacy and long-term
outcomes of
radiofrequency ablation
of the tongue or soft
palate in the treatment
of OSA

Optimal patient selection
criteria have not been
defined

Large controlled studies
or comparative
effectiveness trials with
long-term follow-up
comparing
radiofrequency ablation
to established
procedures are
necessary

Updated supporting information
to reflect the most current
clinical evidence, FDA and CMS
information, and references
Coverage Rationale
this therapy.
Surgical Treatment
The following surgical procedures are proven and medically
necessary for treating obstructive sleep apnea as documented by
polysomnography.
Refer to the Medical Policy titled Attended Polysomnography for Evaluation of
Sleep Disorders for further information. Also see the Definitions section of
the policy for information on the definitions and severity of OSA.

Uvulopalatopharyngoplasty (UPPP): For information regarding
medical necessity review, when applicable, see MCG™ Care Guidelines,
20th edition, 2016, Uvulopalatopharyngoplasty (UPPP), A-0245 (ACG).

Maxillomandibular Advancement Surgery (MMA): For information
regarding medical necessity review, when applicable, see MCG™ Care
Guidelines, 20th edition, 2016, Maxillomandibular Osteotomy and
Advancement, A-0248 (ACG). Also see the Coverage Determination
Guideline titled Orthognathic (Jaw) Surgery.

Multilevel Procedures Whether Done in a Single Surgery or
Phased Multiple Surgeries: There are a variety of procedure
combinations, including mandibular osteotomy and genioglossal
advancement with hyoid myotomy (GAHM). For information regarding
medical necessity review, when applicable, see MCG™ Care Guidelines,
20th edition, 2016, Mandibular Osteotomy, A-0247 (ACG).
The following surgical procedures are unproven and not medically
necessary for treating obstructive sleep apnea:

Laser-assisted uvulopalatoplasty (LAUP)

Palatal implants

Lingual suspension - also referred to as tongue stabilization, tongue
stitch or tongue fixation

Transoral robotic surgery (TORS)

Implantable hypoglossal nerve stimulation

Radiofrequency ablation of the soft palate and/or tongue base
There is insufficient evidence to conclude that laser-assisted
uvulopalatoplasty (LAUP) results in improved apnea-hypopnea index (AHI) or
secondary outcomes. Some studies saw a worsening of symptoms as well as
increased complications.
Results of studies provide preliminary but inconsistent evidence that palatal
24
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
REVISED
Policy Title
Obstructive Sleep
Apnea Treatment
(continued)
Effective Date
Oct. 1, 2016
Summary of Changes
Coverage Rationale
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 peerreviewed 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.
There is insufficient evidence to support the safety, efficacy and long-term
outcomes of transoral robotic surgery (TORS) in the treatment of OSA.
Large, controlled studies, with long-term follow-up, comparing TORS to
established procedures are necessary.
There is insufficient evidence to support the safety, efficacy and long-term
outcomes of hypoglossal nerve stimulation in the treatment of OSA. The
optimal patient selection criteria for the use of hypoglossal nerve stimulation
have not been defined. Randomized controlled trials or comparative
effectiveness trials with long-term follow-up, comparing hypoglossal nerve
stimulation to established procedures are necessary to evaluate the
effectiveness of this technology.
There is insufficient evidence to support the efficacy and long-term outcomes
of radiofrequency ablation of the tongue or soft palate in the treatment of
OSA. Optimal patient selection criteria have not been defined. Large
controlled studies or comparative effectiveness trials with long-term followup comparing radiofrequency ablation to established procedures are
necessary.
Follow-up polysomnography should be performed following surgery to
evaluate response to treatment (Kushida et al., 2006; Ferguson et al.,
2006). Refer to the Medical Policy titled Attended Polysomnography for
Evaluation of Sleep Disorders for further information.
25
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
REVISED
Policy Title
Preterm Labor
Management
26
Effective Date
Aug. 1, 2016
Summary of Changes

Changed policy title; previously
titled Preterm Labor:
Identification and Treatment

Reformatted and reorganized
policy; transferred content to
new template

Revised coverage rationale:
o Replaced language
indicating “the use of
tocolytic therapy beyond 7
days is unproven and not
medically necessary for
preventing spontaneous
preterm birth by prolonging
pregnancy” with “the use of
tocolytic therapy beyond 48
hours is unproven and not
medically necessary for
preventing spontaneous
preterm birth by prolonging
pregnancy”
o Removed and relocated
information pertaining to the
2011 FDA MedWatch alert
warning against use of
terbutaline to treat preterm
labor (see FDA section of
policy for applicable details)
o Added language to indicate
magnesium sulfate is proven
and medically necessary for
treating preterm labor shortterm when the following
criteria are met:

Short-term prolongation
of pregnancy (up to 48
hours) to allow for the
administration of
antenatal corticosteroids
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Tocolytic Therapy
The use of tocolytic therapy beyond 48 hours is unproven and not
medically necessary for preventing spontaneous preterm birth by
prolonging pregnancy.
Available studies fail to demonstrate any benefit of maintenance tocolysis in
terms of gestational age at birth, pregnancy prolongation or birth weight.
Subcutaneous terbutaline pump maintenance therapy is unproven
and not medically necessary for delaying or preventing spontaneous
preterm birth by prolonging pregnancy.
Terbutaline pump maintenance therapy has not been shown to decrease the
risk of preterm birth by prolonging pregnancy.
Magnesium sulfate is proven and medically necessary for treating
preterm labor short-term when the following criteria are met:

Short-term prolongation of pregnancy (up to 48 hours) to allow for the
administration of antenatal corticosteroids in pregnant women who are at
risk of preterm delivery within 7 days; or

Fetal neuroprotection before anticipated early preterm (less than 32
weeks of gestation) delivery
Home Uterine Activity Monitoring
Home uterine activity monitoring (HUAM) is unproven and not
medically necessary for preventing spontaneous preterm birth.
There is insufficient clinical evidence that home uterine activity monitoring,
as an independent variable, reduces the frequency of preterm births.
Available studies fail to demonstrate that the use of HUAM reduces the rate
of preterm delivery and neonatal complications or improves pregnancy
outcomes.
Medical Policy Updates
REVISED
Policy Title
Preterm Labor
Management
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
in pregnant women who
are at risk of preterm
delivery within 7 days;
or

Fetal neuroprotection
before anticipated early
preterm (less than 32
weeks of gestation)
delivery

Updated list of applicable HCPCS
codes; added J3475

Updated supporting information
to reflect the most current
description of services, clinical
evidence, FDA and CMS
information, and references
Coverage Rationale
Total Knee
Replacement
Surgery
(Arthroplasty)
Sep. 1, 2016

Reformatted and reorganized
policy; transferred content to
new template
Revised coverage rationale;
added instruction to refer to the
MCG™ Care Guidelines, 20th
edition, 2016, Musculoskeletal
Surgery or Procedure GRG: SGMS (ISC GRG) for information
regarding medical necessity
review, when applicable
For information regarding medical necessity review, when applicable, see the
following MCG™ Care Guidelines, 20th edition, 2016.

Total Knee Arthroplasty, S-700 (ISC)

Musculoskeletal Surgery or Procedure GRG: SG-MS (ISC GRG)
Transcatheter
Heart Valve
Procedures
Sep. 1, 2016
Reformatted and reorganized
policy; transferred content to
new template
Revised coverage rationale;
replaced references to “U.S.
Food and Drug Administration
(FDA) labeled indications” with
“U.S. Food and Drug
Administration (FDA) labeled
indications, contraindications,
Aortic Valve
Transcatheter aortic heart valve replacement is proven and medically
necessary, when used according to U.S. Food and Drug
Administration (FDA) labeled indications, contraindications,
warnings and precautions, in patients who meet all of the following
criteria:

Severe calcific native aortic valve stenosis as indicated by ONE of the
following:
o Mean aortic valve gradient >40 mmHg; or
o Peak aortic jet velocity >4.0 m/s; or



27
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
REVISED
Policy Title
Transcatheter
Heart Valve
Procedures
(continued)
Effective Date
Sep. 1, 2016
Summary of Changes
warnings, and precautions”

Updated supporting information
to reflect the most current
clinical evidence, FDA and CMS
information, and references
Coverage Rationale
o Aortic valve area of ≤ 0.8 cm2

Patient is symptomatic (New York Heart Association [NYHA] class II or
greater) and symptoms are due to aortic valve stenosis

Patient requires valve replacement surgery but is at high risk for serious
surgical complications or death from open valve replacement surgery as
determined by an interventional cardiologist and an experienced
cardiothoracic surgeon. According to the FDA approval, high risk is
defined as a Society of Thoracic Surgeons (STS) predicted operative risk
score of >8% or an estimated >15% mortality risk for surgical aortic
valve replacement (SAVR).
For a complete list of indications, contraindications, warnings and
precautions by device, see the FDA section of the policy.
Pulmonary Valve
Transcatheter pulmonary heart valve replacement is proven and
medically necessary, when used according to FDA labeled
indications, contraindications, warnings and precautions, in patients
with right ventricular outflow tract (RVOT) dysfunction who meet the
following criteria:

Existence of a full (circumferential) dysfunctional RVOT conduit that was
equal to or greater than 16 mm in diameter when originally implanted,
and

Dysfunctional RVOT conduit with one of the following clinical indications
for intervention:
o Moderate or greater pulmonary regurgitation, or
o Pulmonary stenosis with a mean RVOT gradient ≥ 35 mmHg.
Mitral Valve
Percutaneous transcatheter mitral valve leaflet repair is unproven
and not medically necessary.
There is insufficient evidence in the clinical literature demonstrating the longterm 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. See Benefit Considerations section of the policy
for coverage of unproven services when certain conditions are met.
Percutaneous transcatheter mitral valve annuloplasty via the
coronary sinus is unproven, not medically necessary and
28
Medical Policy Update Bulletin: July 2016
Medical Policy Updates
REVISED
Policy Title
Transcatheter
Heart Valve
Procedures
(continued)
Effective Date
Sep. 1, 2016
Summary of Changes
Coverage Rationale
investigational due to lack of FDA approval.
There is insufficient evidence in the clinical literature demonstrating the longterm efficacy of coronary sinus annuloplasty devices for treating mitral
regurgitation. Further results from prospective, randomized controlled trials
are needed to determine safety, efficacy, durability and the ideal candidates
for the procedure.
Valve-in-Valve (ViV) Procedures
Transcatheter heart valve replacement within a failed bioprosthesis
(valve-in-valve procedure) is unproven and not medically necessary.
There is insufficient evidence in the clinical literature demonstrating the longterm efficacy of ViV procedures. Further results from prospective studies are
needed to determine the ideal candidates for this procedure.
29
Medical Policy Update Bulletin: July 2016
Drug and Biologics Policy Updates
UPDATED
Policy Title
Benlysta®
(Belimumab)
Effective Date
Jul. 1, 2016
Summary of Changes

Updated coverage rationale;
clarified terminology:
o Replaced reference to “antidsDNA” with “anti-doublestranded DNA (anti-dsDNA)”

Updated supporting information
to reflect the most current
clinical evidence, CMS
information, and references
Coverage Rationale
Benlysta (belimumab) is proven and medically necessary for the
treatment of:
1. Systemic lupus erythematosus (SLE) when both of the following
criteria are met:
a. Autoantibody positive [e.g., anti-nuclear antibody (ANA) titer ≥ 1:80
or anti-double-stranded DNA (anti-dsDNA) level ≥ 30 IU/mL]; and
b. Currently receiving at least one standard of care treatment for active
systemic lupus erythematosus (e.g., antimalarials, corticosteroids, or
immunosuppressants)
Benlysta is unproven and not medically necessary for:
1. Severe active lupus nephritis
2. Severe active central nervous system (CNS) lupus
3. Use in combination with other biologics or intravenous cyclophosphamide
4. Waldenström macroglobulinemia
5. Sjögren's syndrome
6. Rheumatoid arthritis
Centers for Medicare and Medicaid Services (CMS):
Medicare does not have a National Coverage Determination (NCD) for
BENLYSTA® (belimumab). Local Coverage Determinations (LCDs) do not
exist at this time.
Medicare may cover 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
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/bp102c15.pdf.
(Accessed April 1, 2016)
Oncology
Medication Clinical
Coverage Policy
30
Jul. 1, 2016

Updated coverage rationale;
modified Additional Information
pertaining to National
Comprehensive Cancer Network
(NCCN) Guidelines:
o Replaced language indicating
“the guidelines are
developed and updated by
Medical Policy Update Bulletin: July 2016
Description
This policy provides parameters for coverage of injectable oncology
medications (J9000 - J9999) and select other medications used for oncology
conditions [including, but not limited to octreotide acetate (J2353 and J2354)
and leuprolide acetate (J1950)] covered under the medical benefit based
upon the National Comprehensive Cancer Network (NCCN) Drugs & Biologics
Compendium® (NCCN Compendium®). The Compendium lists the appropriate
drugs and biologics for specific cancers using US Food and Drug
Drug and Biologics Policy Updates
UPDATED
Policy Title
Oncology
Medication Clinical
Coverage Policy
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
47 individual panels,
composed of more than 950
clinicians and oncology
researchers from the 25
NCCN member institutions
and their affiliates” with “the
guidelines are developed and
updated by 67 individual
panels, composed of more
than 1000 clinicians and
oncology researchers from
the 26 NCCN member
institutions and their
affiliates”
Coverage Rationale
Administration (FDA)-approved disease indications and specific NCCN panel
recommendations. Each recommendation is supported by a level of evidence
category.
Coverage Rationale
UnitedHealthcare recognizes indications and 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
medically necessary, and Categories of Evidence and Consensus of 3 as
unproven and not medically necessary (however, see Benefit
Considerations section of the policy for additional information).
UnitedHealthcare will cover all chemotherapy agents for individuals under the
age of 19 years for oncology indications. 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 (NCCN Guidelines®) are a
comprehensive set of guidelines documenting sequential management
decisions and interventions and interventions that apply to malignancies
which affect about 97% of all patients with cancer. They also address
supportive care issues. The guidelines are developed and updated by 67
individual panels, composed of more than 1000 clinicians and oncology
researchers from the 26 NCCN member institutions and their affiliates.
NCCN Categories of Evidence and Consensus
Category 1: The recommendation is based on high-level evidence (ie, highpowered 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
31
Medical Policy Update Bulletin: July 2016
Drug and Biologics Policy Updates
UPDATED
Policy Title
Oncology
Medication Clinical
Coverage Policy
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale
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 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.
Repository
Corticotropin
Injection (H.P.
Acthar Gel®)
32
Jul. 1, 2016

Updated supporting information
to reflect the most current
clinical evidence, CMS
information, and references; no
change to coverage rationale or
lists of applicable codes
Medical Policy Update Bulletin: July 2016
H.P. Acthar Gel (repository corticotropin injection) is proven for the
treatment of:
1. Infantile spasm (i.e., West Syndrome) 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. H.P. Acthar Gel dosing for infantile spasm is as follows:
1. Initial dose: 75 U/m2 intramuscular (IM) twice daily for 2 weeks.
2. After 2 weeks, dose should be tapered according to the following
schedule: 30 U/m2 IM in the morning for 3 days; 15 U/m2 IM in
the morning for 3 days; 10 U/m2 IM in the morning for 3 days;
Drug and Biologics Policy Updates
UPDATED
Policy Title
Repository
Corticotropin
Injection (H.P.
Acthar Gel®)
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale
and 10 U/m2 IM every other morning for 6 days (3 doses).
Additional information to support medical necessity
review where applicable:
The above indication and criteria also apply to medical necessity
review.
2. Opsoclonus-myoclonus syndrome (i.e., OMS, Kinsbourne Syndrome)
3. Multiple sclerosis (MS), acute exacerbation
Additional information to support medical necessity review where
applicable:
H.P. Acthar Gel is not medically necessary for treatment of acute
exacerbations of multiple sclerosis.
The H.P. Acthar package insert has listed other conditions in which it may be
used. Since H.P. Acthar is more costly than an alternative drug that is at
least as likely to produce equivalent therapeutic results, UHCP has
determined that use of H.P. Acthar Gel is unproven and not medically
necessary for treatment of the following disorders and diseases:
1. Rheumatic Disorders: psoriatic arthritis, rheumatoid arthritis, including
juvenile rheumatoid arthritis, ankylosing spondylitis
2. Collagen Diseases: systemic lupus erythematosus, systemic
dermatomyositis (polymyositis)
3. Dermatologic Diseases: Severe erythema multiforme, Stevens-Johnson
syndrome
4. Allergic States: Serum sickness
5. Ophthalmic Diseases: Severe acute and chronic allergic and
inflammatory processes involving the eye and its adnexa such as:
keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic
neuritis, chorioretinitis, anterior segment inflammation
6. Respiratory Diseases: Symptomatic sarcoidosis
7. Edematous State: To induce a diuresis or a remission of proteinuria in
the nephrotic syndrome without uremia of the idiopathic type or that due
to lupus erythematosus.
8. Any indication outside of the proven indications above
Centers for Medicare and Medicaid Services (CMS):
Medicare does not have a National Coverage Determination (NCD) for H.P.
Acthar® (repository corticotropin injection). Local Coverage Determinations
(LCDs) exist; see the LCDs for Corticotropin.
33
Medical Policy Update Bulletin: July 2016
Drug and Biologics Policy Updates
UPDATED
Policy Title
Repository
Corticotropin
Injection (H.P.
Acthar Gel®)
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale
Medicare may cover 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
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/bp102c15.pdf.
(Accessed March 30, 2016)
Rituxan®
(Rituximab)
Jul. 1, 2016

Please refer to the Oncology Medication Clinical Coverage Policy for updated
information based upon the National Comprehensive Cancer Network (NCCN)
Drugs & Biologics Compendium® (NCCN Compendium®) for oncology
indications.
Routine review; no change to
coverage rationale or lists of
applicable codes
Rituxan (rituximab) is proven for the treatment of:
1. Immune thrombocytopenic purpura (ITP)
2.
3.
4.
5.
34
Medical Policy Update Bulletin: July 2016
Additional information to support medical necessity review where
applicable:
Rituximab 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. **History of failure, contraindication, or intolerance to one of the
following:
(1) Corticosteroids
(2) Immune globulin
(3) Splenectomy
Autoimmune mucocutaneous blistering diseases
Rituxan is proven and medically necessary for the treatment of
Wegener’s granulomatosis or microscopic polyangiitis (both
ANCA-associated vasculidities) when both of the following criteria
are met:
a. Diagnosis of Wegener’s granulomatosis or microscopic polyangiitis;
and
b. One of the following:
(1) Patient is receiving concurrent therapy with glucocorticoids
(2) **History of contraindication or intolerance to glucocorticoids
Autoimmune hemolytic anemia, including chronic cold agglutinin
disease
Rituxan is proven and medically necessary for the treatment of
Drug and Biologics Policy Updates
UPDATED
Policy Title
Rituxan®
(Rituximab)
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale
rheumatoid arthritis when all of the following criteria are met:
a. Moderate to severe disease activity [e.g., swollen, tender joints with
limited range of motion]; and
b. One of the following:
(1) Patient is receiving concurrent therapy with methotrexate
(2) **History of contraindication or intolerance to methotrexate; and
c. **History of failure, contraindication or intolerance to at least one
tumor necrosis factor (TNF) inhibitors [e.g., adalimumab (Humira),
etanercept (Enbrel), infliximab (Remicade)]; and
d. Patient is not receiving rituximab in combination with either of the
following:
(1) Biologic DMARD [e.g., Enbrel (etanercept), Humira
(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]
(2) Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]
6. Post-transplant B-lymphoproliferative disorder
7. Neuromyelitis optica
Rituxan is unproven and not medically necessary for the treatment of:
1. Anti-GM1 antibody-related neuropathies
2. Kaposi sarcoma-associated herpes virus-related multicentric Castleman
disease
3. Pure red cell aplasia
4. Systemic lupus erythematosus
5. Acquired factor VIII inhibitors
6. Polyneuropathy associated with anti-MAG antibodies
7. Idiopathic membranous nephropathy
8. Chronic graft-versus-host disease
9. Reduction of anti-HLA antibodies in patients awaiting renal transplant
10. Multiple sclerosis
11. Dermatomyositis and polymyositis
While a beneficial effect of rituximab has been reported in some of these
conditions, none of them have shown positive results in large, controlled
clinical trials.
Centers for Medicare and Medicaid Services (CMS):
Medicare does not have a National Coverage Determination (NCD) for
rituximab. Local Coverage Determinations (LCDs) exist; see the LCDs for
Rituximab (Rituxan®) and Drugs and Biologicals: Rituximab (Rituxan®).
35
Medical Policy Update Bulletin: July 2016
Drug and Biologics Policy Updates
UPDATED
Policy Title
Rituxan®
(Rituximab)
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale
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. Refer to the Medicare
Benefit Policy Manual (Pub. 100-2), Chapter 15, section 50 Drugs and
Biologicals at https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/bp102c15.pdf.
(Accessed March 29, 2016)
Soliris®
(Eculizumab)
Jul. 1, 2016

Proven
Atypical Hemolytic Uremic Syndrome (aHUS)
Eculizumab is indicated for the treatment of atypical hemolytic uremic
syndrome (aHUS).
Routine review; no change to
coverage rationale or lists of
applicable codes
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Eculizumab is indicated for the treatment of paroxysmal nocturnal
hemoglobinuria (PNH).
Hillmen et al evaluated the long-term safety and efficacy of continuous
administration of eculizumab in 195 patients with paroxysmal nocturnal
hemoglobinuria (PNH) over 66 months. Patients previously enrolled in the
Phase II pilot study and its extensions, the Phase III TRIUMPH (Transfusion
Reduction Efficacy and Safety Clinical Investigation, a Randomized,
Multicenter, Double-Blind, Placebo-Controlled, Using Eculizumab in
Paroxysmal Nocturnal Hemoglobinuria) study (NCT00122330), or the Phase
III SHEPHERD (Safety in Hemolytic PNH Patients Treated With Eculizumab: A
Multi-Center Open-Label Research Design) study (NCT00130000) were
eligible to participate. All patients had a minimum of 10% PNH red blood
cells at enrolment in the parent trials and were vaccinated with a
meningococcal vaccine at least 14 days prior to the first eculizumab infusion
in the parent studies. Efficacy assessments were performed at least every 2
weeks from the time of initiation of eculizumab therapy in the parent study.
Efficacy endpoints included patient survival degree of hemolysis, thrombotic
events (TE), mean change from baseline in hemoglobin and the number of
units of transfused packed red blood cells (PRBCs) administered.
Assessments of renal function were performed over the duration of the study
by determining the CKD stage using formulas for estimated glomerular
filtration rate (GFR). Safety was assessed through monitoring of adverse
events (AEs), clinical laboratory tests and vital signs. Four patient deaths
were reported, all unrelated to treatment, resulting in a 3-year survival
36
Medical Policy Update Bulletin: July 2016
Drug and Biologics Policy Updates
UPDATED
Policy Title
Soliris®
(Eculizumab)
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
Coverage Rationale
estimate of 97.6%. All patients showed a reduction in lactate dehydrogenase
levels, which was sustained over the course of treatment (median reduction
of 86.9% at 36 months). The incidence of reported TEs decreased by 81.8%,
with 96.4% of patients remaining free of TEs. Researchers observed a timedependent improvement in renal function: 93.1% of patients exhibited
improvement or stabilization in CKD score at 36 months. Transfusion
independence increased by 90.0% from baseline, with the number of red
blood cell units transfused decreasing by 54.7%. The median treatment
duration was 30.3 months with a maximum duration of 66 months.
Eculizumab was well tolerated, with no evidence of cumulative toxicity and a
decreasing occurrence of adverse events over time. Very few patients
discontinued treatment. Researchers concluded that long-term treatment
with eculizumab resulted in sustained improvement in patient outcomes by
rapidly reducing hemolysis and significantly reducing the frequency of severe
and life-threatening morbidities, such as TEs and CKD, and thus, improving
patient survival.
Unproven
Eculizumab is not indicated for the treatment of patients with Shiga toxin E.
coli related hemolytic uremic syndrome (STEC-HUS). While the few studies
available demonstrate possible efficacy of eculizumab in treating Shiga toxin
E. coli-related hemolytic uremic syndrome, further studies are warranted to
demonstrate that it is both safe and effective for this indication.
Vaccines
37
Jul. 1, 2016

Updated benefit considerations;
modified language pertaining to
preventive services mandated by
the federal Patient Protection
and Affordable Care Act (PPACA)
to indicate:
o For non-grandfathered plans
and grandfathered plans
wishing to offer such
coverage, UnitedHealthcare
will cover preventive
services as mandated by
PPACA, with no cost sharing
when provided by a network
provider for those vaccines
Medical Policy Update Bulletin: July 2016
The standard UnitedHealthcare Certificate of Coverage covers preventive
health services, including immunizations, administered in a physician office.
Some immunizations are excluded, e.g., immunizations that are required for
travel, employment, education, insurance, marriage, adoption, military
service, or other administrative reasons.
An immunization that does not fall under one of the exclusions in the
Certificate of Coverage is considered covered after all of the following
conditions are satisfied:
1. US Food and Drug Administration (FDA) approval;
2. ACIP definitive ("shall") recommendation rather than a permissive
("may") recommendation published in the Morbidity & Mortality Weekly
Report (MMWR) of the Centers for Disease Control and Prevention (CDC).
Implementation will typically occur within 60 days after publication in the
Drug and Biologics Policy Updates
UPDATED
Policy Title
Vaccines
(continued)
Effective Date
Jul. 1, 2016
Summary of Changes
with a definitive approval
from the Advisory
Committee on Immunization
Practices (ACIP) of the
Centers for Disease Control
and Prevention (CDC) and
Health Resources and
Services Administration
(HRSA) Guidelines including
the American Academy of
Pediatrics Bright Futures
periodicity guidelines

Updated supporting information
to reflect the most current CMS
information
Coverage Rationale
MMWR.
Summary of Changes

Revised coverage rationale;
replaced language indicating
“Mifeprex (mifepristone) is
proven and medically necessary
for termination of pregnancy
through 63 days gestation when
administered under the
supervision of a qualified
physician” with “Mifeprex
(mifepristone) is proven and
medically necessary for
termination of pregnancy
through 70 days gestation when
administered under the
supervision of a qualified
physician”

Updated supporting information
to reflect the most current
Coverage Rationale
Mifeprex (mifepristone) is proven and medically necessary for
termination of pregnancy through 70 days gestation when administered
under the supervision of a qualified physician. For purposes of this treatment,
pregnancy is dated from the first day of the last menstrual period in a
presumed 28 day cycle with ovulation occurring at mid-cycle.
Please also refer to UnitedHealthcare’s Preventive Care Services Guideline for
additional information on vaccines covered as preventive services.
Centers for Medicare and Medicaid Services (CMS):
Medicare does not have a National Coverage Determination (NCD) for
Immunizations. Local Coverage Determinations (LCDs) exist; see the LCDs
for Immunizations and the Local Coverage Articles (LCAs) for Tetanus
Immunization- Medical Policy Article
For specific coverage information of immunizations under the Medicare Part B
program, refer to the Medicare Benefit Policy Manual (Pub. 100-2) Chapter
15 Covered Medical and Other Health Services Section 50.4.4.2
Immunizations available at https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/bp102c15.pdf.
(Accessed April 4, 2016)
REVISED
Policy Title
Mifeprex®
(Mifepristone, RU486)
38
Effective Date
Aug. 1, 2016
Medical Policy Update Bulletin: July 2016
Mifeprex should be prescribed only by physicians who have read and
understood the prescribing information. Mifeprex may be administered only
in a clinic, medical office, or hospital, by or under the supervision of a
physician, able to assess the gestational age of an embryo and to diagnose
ectopic pregnancies. Physicians must also be able to provide surgical
intervention in cases of incomplete abortion or severe bleeding, or have
made plans to provide such care through others, and be able to assure
patient access to medical facilities equipped to provide blood transfusions
and resuscitation, if necessary.
Mifeprex is unproven for treatment of:
1. Leiomyomata
Drug and Biologics Policy Updates
REVISED
Policy Title
Mifeprex®
(Mifepristone, RU486)
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
clinical evidence, FDA and CMS
information, and references
Coverage Rationale
2. Endometriosis
3. Breast cancer
4. Ovarian cancer
5. Meningioma
6. Psychotic major depression
7. Oral contraception
8. Induction of labor
Centers for Medicare and Medicaid Services (CMS):
Medicare does not have a National Coverage Determination (NCD) specific to
Mifeprex® (mifepristone). Local Coverage Determinations (LCDs) for
Mifeprex® (mifepristone) do not exist at this time.
In general, Medicare may cover 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. Refer to the Medicare
Benefit Policy Manual (Pub. 100-2), Chapter 15, section 50 Drugs and
Biologicals at https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/downloads/bp102c15.pdf.
(Accessed April 4, 2016)
39
Medical Policy Update Bulletin: July 2016
Coverage Determination Guideline (CDG) Updates
UPDATED
Policy Title
Breast
Reconstruction Post
Mastectomy
Effective Date
Sep. 1, 2016
Summary of Changes

Reformatted and reorganized
policy; transferred content to
new template

Updated list of applicable HCPCS
codes for breast reconstruction
post mastectomy; added S2066,
S2067, and S2068
Coverage Rationale
Indications for Coverage
Breast reconstruction is covered for members who have a mastectomy
with or without a diagnosis of cancer. Mastectomy includes partial
(lumpectomy, tylectomy, quadrantectomy, and segmentectomy), simple,
and radical. This benefit does not include aspirations, biopsy (open or
core), excision of cysts, fibroadenomas or other benign or malignant
tumors, aberrant breast tissue, duct lesions, nipple or areolar lesions, or
treatment of gynecomastia.
There is not a timeframe in which the member is required to have the
reconstruction done post mastectomy under the Women’s Health and
Cancer Rights Act of 1998.
In accordance with Federal and State mandates, the following services are
covered:

Reconstruction of the breast on which the mastectomy was performed

Surgery and reconstruction of the other breast to produce a symmetrical
appearance, including nipple tattooing

Prosthesis (implanted and/or external)

Treatment of physical complications of mastectomy, including
lymphedema
Various surgical techniques are used for breast reconstruction, including
but not limited to:

Insertion of FDA approved breast implants and tissue expanders

Breast Implants and tissue expanders post mastectomy with or without
skin substitutes, approved by the FDA, including but not limited to
Alloderm, Allomax or FlexHD are a covered benefit

Transverse Rectus Abdominus Myocutaneous Flap (TRAM)

Latissimus Dorsi Flap (LD)

Deep Inferior Epigastric Perforator (DIEP) Flap

Gluteal Flap (GAP free flap)
Refer to the Definitions section of this Coverage Determination Guideline
(CDG) for breast reconstruction procedure definitions.
If the original implant or reconstructive surgery was considered
reconstructive surgery under the UnitedHealthcare benefit document,
coverage may exist for removal, replacement, and/or reconstruction. If
40
Medical Policy Update Bulletin: July 2016
Coverage Determination Guideline (CDG) Updates
UPDATED
Policy Title
Breast
Reconstruction Post
Mastectomy
(continued)
Effective Date
Sep. 1, 2016
Summary of Changes
Coverage Rationale
the original implant or reconstructive surgery was considered
reconstructive surgery under the UnitedHealthcare benefit document, then
removal of a ruptured prosthesis is treating a "complication arising from a
medical or surgical intervention." Removal or replacement of an implant
that is not ruptured and unassociated with local breast complications may
not be covered.
Additional Information
A gap exception may be granted if there is not an in-network provider
able to provide the requested reconstructive procedure. Refer to the
member specific benefit document for information regarding coverage
from non-network providers.
Breast reconstruction may be covered under certain circumstances for the
surgical treatment of gender dysphoria. Please refer to the member
specific benefit document for coverage.
Treatments for Complications Post Mastectomy

Lymphedema:
o Complex Decongestive Physiotherapy (CDP) is covered for the
complication of lymphedema post-mastectomy
o Lymphedema pumps when required are covered (when covered
these pumps are covered as Durable Medical Equipment)
o Compression lymphedema sleeves are covered (when covered, these
sleeves are covered as a Prosthetic Device)
o Elastic bandages and wraps associated with covered treatments for
the complications of lymphedema

Treatment of a post-operative infection(s)

Removal of a ruptured breast implant (either silicone or saline) is
reconstructive for implants done post-mastectomy. Placement of a new
breast implant will be covered if the original implantation was done postmastectomy or for a covered reconstructive health service.
Coverage Limitations and Exclusions
Please refer to the member’s state mandates and the member specific
benefit documents.

Insertion of breast implants or reinsertion of breast implants for the
purpose of improving appearance is a cosmetic procedure unless covered
under a state or federal mandate.
41
Medical Policy Update Bulletin: July 2016
Coverage Determination Guideline (CDG) Updates
UPDATED
Policy Title
Breast
Reconstruction Post
Mastectomy
(continued)
Effective Date
Sep. 1, 2016
Summary of Changes
Coverage Rationale
o If the breast reconstruction has been successfully completed post
mastectomy and the member chooses to enlarge their breasts for
cosmetic reasons, this is considered a cosmetic service and is not a
covered health service.

Breast reconstruction or scar revision after breast biopsy or removal of a
cyst with or without a biopsy usually does not meet the definition of a
covered reconstructive health service. Refer to the member specific
benefit plan document and applicable state mandates.

Tissue protruding at the end of a scar (“dog ear”/standing cone), painful
scars or donor site scar revisions must be reviewed to determine if the
procedure meets reconstructive guidelines.

Liposuction other than to achieve breast symmetry during post
mastectomy reconstruction is considered cosmetic and is not a covered
health service.

Revision of prior reconstructed breast due to normal aging does not meet
the definition of a covered reconstructive health service.

Unproven services.
Effective Date
Aug. 1, 2016
Summary of Changes

Reformatted and reorganized
policy; transferred content to
new template

Revised coverage rationale/
indications for coverage:
o Updated Criteria for a
Coverage Determination as
Reconstructive; removed
criterion requiring
“diagnostic tests, if done,
have ruled out other causes
of the functional impairment”
o Modified language pertaining
to documentation
requirements; replaced
language indicating “ the
[noted] documentation may
be requested as part of the
Coverage Rationale
California Mandate for Medically Necessary Surgery: The State of
California requires that all breast reduction surgeries be reviewed for medical
necessity. Benefits will be provided if the breast reduction meets the Criteria
for a Coverage Determination as Reconstructive identified below.
REVISED
Policy Title
Breast Reduction
Surgery
42
Medical Policy Update Bulletin: July 2016
Indications for Coverage
Breast reduction surgery following mastectomy to achieve symmetry is
covered as part of the Women’s Health and Cancer Rights Act (WHCRA).
Please refer to the Coverage Determination Guideline titled Breast
Reconstruction Post Mastectomy.
Breast reconstruction may be covered under certain circumstances for the
surgical treatment of gender dysphoria. Please refer to the member specific
benefit plan document for coverage.
All plans cover breast reduction surgeries that qualify under the
Women’s Health and Cancer Rights Act of 1998.
If a surgery does not qualify under the Women’s Health and Cancer Rights
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Breast Reduction
Surgery
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
review” with “the [noted]
documentation should be
available for review”
Coverage Rationale
Act of 1998, certain plans may allow breast reduction surgery which we
determine to treat a physiologic functional impairment. However, certain
plans exclude breast reduction surgery even if it treats a physiologic
functional impairment. Refer to the member specific benefit plan document
to determine coverage.
For Plans that Cover Breast Reduction Surgery that Treat a
Physiologic Functional Impairment (Including California Reviews for
Medical Necessity)
Criteria for a Coverage Determination as Reconstructive
Breast reduction surgery is considered reconstructive and medically
necessary when the following criteria are met and a physiologic functional
impairment is identified:

Macromastia is the primary etiology of the member’s functional
impairment or impairments (as defined in the Definitions section of the
policy). The following are examples of functional impairments that must
be attributable to macromastia to be considered (not an all-inclusive
list):
o Severe skin excoriation/intertrigo unresponsive to medical
management
o Severe restriction of physical activities that meets the definition of
functional impairment
o Signs and symptoms of nerve compression that are unresponsive to
medical management (e.g., ulnar paresthesias)
o Acquired kyphosis that is attributed to macromastia
o Chronic breast pain due to weight of the breasts
o Upper back, neck, or shoulder pain
o Shoulder grooving from bra straps
o Headache
and

The amount of tissue to be removed plots above the 22nd percentile; or

If the amount of tissue to be removed plots between the 5th and 22nd
percentiles, the procedure may be either reconstructive or cosmetic; the
determination is based on the review of the information provided; and

The proposed procedure is likely to result in significant improvement of
the functional impairment.
The Following Documentation Should be Available for Review
Reduction Mammoplasty documentation should include the evaluation and
43
Medical Policy Update Bulletin: July 2016
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Breast Reduction
Surgery
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
Coverage Rationale
management note for the date of service and the note for the day the
decision to perform surgery was made. The member’s medical record must
contain, and be available for review on request, the following information:

Height and weight

Body Surface Area (BSA)

Photographs that document macromastia
Coverage Limitations and Exclusions
Some states require benefit coverage for services that UnitedHealthcare
considers cosmetic procedures, such as repair of external congenital
anomalies in the absence of a functional impairment. Please refer to the
member specific benefit plan documents.

Cosmetic Procedures are excluded from coverage. Procedures that
correct an anatomical Congenital Anomaly without improving or restoring
physiologic function are considered Cosmetic Procedures. The fact that a
Covered Person may suffer psychological consequences or socially
avoidant behavior as a result of an Injury, Sickness or Congenital
Anomaly does not classify surgery (or other procedures done to relieve
such consequences or behavior) as a reconstructive procedure.

Any procedure that does not meet the reconstructive criteria above in
the Indications for Coverage section (e.g., psychological or social
reasons, breast size asymmetry unless post mastectomy, exercise.

Breast reduction surgery is cosmetic when done to improve appearance
without improving a functional/physiologic impairment.

The use of liposuction as the sole procedure for breast reduction surgery
is considered cosmetic.
Appendix
This Schnur chart may be used to assess whether the amount of tissue that
will be removed is reasonable for the body habitus, and whether the
procedure is cosmetic or reconstructive in nature.

If the amount plots above the 22nd percentile and the member has a
functional impairment, the procedure is reconstructive.

If the amount plots below the 5th percentile, the procedure is cosmetic.

If the amount plots between the 5th and 22nd percentiles, the procedure
may be either reconstructive or cosmetic based on review of information.
To calculate body surface area (BSA), see:
http://www.cornellpediatrics.org/ser_div/critical/calc/bsacalc.htm
44
Medical Policy Update Bulletin: July 2016
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Breast Reduction
Surgery
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
Coverage Rationale
or
BSA = (W 0.425 x H 0.725) x 0.007184
(weight is in kilograms and height is in centimeters)
Modified Schnur Nomogram Chart
Body Surface (m2)
1.35
1.40
1.45
1.50
1.55
1.60
1.65
1.70
1.75
1.80
1.85
1.90
1.95
2.00
2.05
2.10
2.15
2.20
2.25
2.30
2.35
2.40
2.45
2.50
2.55
Cosmetic and
Reconstructive
Procedures
Sep. 1, 2016


45
Reformatted and reorganized
policy; transferred content to
new template
Revised coverage
rationale/criteria for a procedure
to be considered reconstructive
Medical Policy Update Bulletin: July 2016
Lower 5th Percentile
127
139
152
166
181
198
216
236
258
282
308
336
367
401
439
479
523
572
625
682
745
814
890
972
1,062
Lower 22nd Percentile
199
218
238
260
284
310
338
370
404
441
482
527
575
628
687
750
819
895
978
1,068
1,167
1,275
1,393
1,522
1,662
Some states require benefit coverage for services that UnitedHealthcare
considers cosmetic procedures, such as repair of external congenital
anomalies in the absence of a functional impairment. Please refer to the
member’s plan specific documents.
Indications for Coverage
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Cosmetic and
Reconstructive
Procedures
(continued)
46
Effective Date
Sep. 1, 2016
Summary of Changes
and medically necessary; added
language to indicate:
o Microtia repair is
reconstructive; although no
functional impairment may
be documented for microtia,
this has been deemed
reconstructive surgery

Updated list of applicable
procedure codes:
o Removed CPT code 30120
(refer to the Coverage
Determination Guideline
titled Rhinoplasty and Other
Nasal Surgeries for
applicable coverage
guidelines)
o Removed HCPCS codes
S2066, S2067, and S2068
(refer to the Coverage
Determination Guideline
titled Breast Reconstruction
Post Mastectomy for
applicable coverage
guidelines)
o Updated coding clarification
language for flaps (skin
and/or deep tissue)
procedures (CPT codes
15570-15738); removed
language indicating the
regions listed refer to a
donor site when a tube is
formed for later transfer or
when a "delay" of flap occurs
prior to the transfer

Updated definitions:
o Added definition of
“microtia”
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Criteria for a Procedure to be Considered Reconstructive and
Medically Necessary

There is documentation that the physical abnormality and/or
physiological abnormality is causing a functional impairment (as defined
in the Definitions section of the policy) that requires correction

The proposed treatment is of proven efficacy and is deemed likely to
significantly improve or restore the patient’s physiological function

Microtia repair (as defined in the Definitions section of the policy) is
reconstructive; although no functional impairment may be documented
for Microtia, this has been deemed reconstructive surgery
Coverage Limitations and Exclusions
Some states require benefit coverage for services that UnitedHealthcare
considers cosmetic procedures, such as repair of external congenital
anomalies in the absence of a functional impairment. Please refer to the
member specific benefit plan document.

Cosmetic Procedures are excluded from coverage. Procedures that
correct an anatomical Congenital Anomaly without improving or restoring
physiologic function are considered Cosmetic Procedures. The fact that a
Covered Person may suffer psychological consequences or socially
avoidant behavior as a result of an Injury, Sickness or Congenital
Anomaly does not classify surgery (or other procedures done to relieve
such consequences or behavior) as a reconstructive procedure.

Any procedure that does not meet the reconstructive criteria above in
the Indications for Coverage section is excluded from coverage.
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Cosmetic and
Reconstructive
Procedures
(continued)
Effective Date
Sep. 1, 2016
Summary of Changes
o Removed definition of:

Abdominoplasty

Blepharoplasty

Brow ptosis

Breast reduction
mammoplasty

Cleft lip & palate

Mastectomy

Panniculectomy

Panniculus

Ptosis of eyelids

Visual field
Coverage Rationale
Pectus Deformity
Repair
Sep. 1, 2016

Indications for Coverage
Surgical repair of pectus excavatum is considered reconstructive and
medically necessary when the following criteria has been met:

47
Reformatted and reorganized
policy; transferred content to
new template
Revised coverage
rationale/indications for
coverage for pectus excavatum
to indicate surgical repair of
pectus excavatum is considered
reconstructive and medically
necessary when the following
criteria has been met:
o Imaging studies confirm
Haller index greater than
3.25; and
o A functional impairment
defined in physician current
office notes; and

For restrictive lung
capacity the total lung
capacity is documented
in the physician current
office notes as <80% of
the predicted value; or

There is cardiac
compromise as
demonstrated by
Medical Policy Update Bulletin: July 2016
Pectus Excavatum

Imaging studies confirm Haller index greater than 3.25; and

A functional impairment defined in physician current office notes, and
o For restrictive lung capacity the total lung capacity is documented in
the physician current office notes as <80% of the predicted value; or
o There is cardiac compromise as demonstrated by decreased cardiac
output on the echocardiogram; or
o There is objective evidence of exercise intolerance as documented by
cardiopulmonary exercise testing that is below the predicted values.
Pectus Carinatum
It is extremely uncommon that pectus carinatum will cause a
functional/physiological deficit. Pectus carinatum is not a congenital
anomaly; it is a developmental condition of the cartilage that generally
occurs during an adolescents growth spurt. (Goretsky, 2004) Requests for
coverage of repair of pectus carinatum will be reviewed by a UHC Medical
Director on a case by case basis.
Coverage Limitations and Exclusions
Some states require benefit coverage for services that UnitedHealthcare
considers cosmetic procedures, such as repair of external congenital
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Pectus Deformity
Repair
(continued)
Effective Date
Sep. 1, 2016
Summary of Changes
decreased cardiac output
on the echocardiogram;
or

There is objective
evidence of exercise
intolerance as
documented by
cardiopulmonary
exercise testing that is
below the predicted
values
Coverage Rationale
anomalies in the absence of a functional/ physical impairment. Please refer
to the member specific benefit plan document.

Cosmetic Procedures are excluded from coverage. Procedures that
correct an anatomical Congenital Anomaly without improving or restoring
physiologic function are considered Cosmetic Procedures. The fact that a
Covered Person may suffer functional/psychological consequences or
socially avoidant behavior as a result of an Injury, Sickness or Congenital
Anomaly does not classify surgery (or other procedures done to relieve
such consequences or behavior) as a reconstructive procedure.

Any procedure that does not meet the reconstructive criteria above in
the Indications for Coverage section.
Private Duty
Nursing Services
(PDN)
Aug. 1, 2016

Indications for Coverage
Before using this guideline, refer to the members plan document and any
federal or state mandates to determine if the plan has an exclusion for
Private Duty Nursing. If the plan has the exclusion for Private Duty Nursing
then the services are not eligible for coverage. When Private Duty Nursing is
a covered benefit, please refer to the member specific benefit plan document
for additional information regarding benefit coverage.

48
Reformatted and reorganized
policy; transferred content to
new template
Revised coverage rationale:
o Clarified terminology;
replaced references to “state
contract” with “any federal
or state mandate
requirements”
o Updated indications of
coverage; added instruction
to:

Refer to the member
specific benefit plan
document and any
federal or state
mandates to determine if
the plan has an exclusion
for private duty nursing
prior to using this
guideline

Refer to the member
specific benefit plan
document for additional
information regarding
benefit coverage when
private duty nursing is a
Medical Policy Update Bulletin: July 2016
Requirements for Coverage
The services being requested must meet all of the following:

Be ordered and directed by the treating practitioner or specialist (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
services are:
o Skilled Care services (please see Coverage Determination Guideline
titled Skilled Care and Custodial Care Services and the Definitions
section of the policy)
o Required on a continuous basis rather than short term intermittent
care
o Subject to frequent reassessments and changes in treatment
o Private Duty Nursing services provided in the home
o Not Custodial Care

A written treatment plan and a letter of medical necessity must be
submitted by the treating practitioner or specialist (M.D., D.O., P.A. or
N.P) with the request for specific services and equipment; and

Continuation of services requires documentation to support the need for
ongoing treatment; and
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Private Duty
Nursing Services
(PDN)
(continued)
49
Effective Date
Aug. 1, 2016
Summary of Changes
covered benefit
o Updated/clarified
requirements for coverage to
indicate:

Services being requested
must meet all of the
following:
Be ordered and
directed by the
treating practitioner
or specialist (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
services are:

Skilled care
services (see the
Coverage
Determination
Guideline titled
Skilled Care and
Custodial Care
Services and the
Definitions
section of the
policy)

Required on a
continuous basis
rather than short
term intermittent
care

Subject to
frequent
reassessments
and changes in
Medical Policy Update Bulletin: July 2016
Coverage Rationale

Private Duty Nursing Care services must be clinically appropriate and not
more costly than alternative health services.
Note: The absence of an available care giver does not make the requested
services Skilled Care.
Plans may require the caregiver to provide a certain number of hours of care
for the patient. Check the member specific benefit documents or the federal
or state mandate requirements for the maximum number of Private Duty
Nursing Hours.
Coverage Limitations and Exclusions

Services beyond the plan benefits (hours or days)

Requested services are excluded in the benefit documents or state
specific contracts

Requested services are defined as non-skilled or Custodial Care in the
member’s plan specific documents (refer to the Coverage Determination
Guideline titled Skilled Care and Custodial Care Services, the member
specific benefit plan document, or any federal or state mandate
requirements)

Respite care and convenience care unless mandated (respite care
relieves the caregiver of the need to provide services to the patient)

Services that can be provided safely and effectively by a non-clinically
trained person are not skilled when a non-skilled caregiver is not
available

Services that involve payment of family members or nonprofessional
caregivers for services performed for the member unless required by
state contract

Services when the member does not meet criteria for Skilled Care
services

Member is no longer eligible for benefits under the plan or any federal or
state mandate requirements
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Private Duty
Nursing Services
(PDN)
(continued)
50
Effective Date
Aug. 1, 2016
Summary of Changes
treatment

Private duty
nursing services
provided in the
home

Not custodial
care
A written treatment
plan and a letter of
medical necessity
must be submitted
by the treating
practitioner or
specialist (M.D.,
D.O., P.A. or N.P)
with the request for
specific services and
equipment; and
Continuation of
services requires
documentation to
support the need for
ongoing treatment;
and
Private duty nursing
care services must
be clinically
appropriate and not
more costly than
alternative health
services

The absence of an
available care giver does
not make the requested
services skilled care

Plans may require the
caregiver to provide a
certain number of hours
of care for the patient;
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Private Duty
Nursing Services
(PDN)
(continued)
Effective Date
Aug. 1, 2016
Summary of Changes
check the member
specific benefit plan
document or the federal
or state mandate
requirements for the
maximum number of
private duty nursing
hours

Updated definitions; added
definition of:
o Home
o Intermittent care
o Private duty nursing
Coverage Rationale
Preventive Care
Services
Oct. 1, 2016

Refer to the policy for complete details on the coverage guidelines for
Preventive Care Services.

51
Removed all references to ICD-9
procedure and diagnosis codes
(discontinued Oct. 1, 2015)
Revised list of applicable
procedure and diagnosis codes
for Preventive Care Services:
Anemia, Iron Deficiency
Anemia Screening
o Removed benefit coverage
guidelines due to September
2015 USPSTF ‘I’ rating
Diabetes Screening
o Revised service description:

Removed June 2008
USPSTF ‘B’ rating

Added October 2015
USPSTF ‘B’ rating:
- The USPSTF
recommends
screening for
abnormal blood
glucose as part of
cardiovascular risk
assessment in adults
aged 40 to 70 years
Medical Policy Update Bulletin: July 2016
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Preventive Care
Services
(continued)
52
Effective Date
Oct. 1, 2016
Summary of Changes
who are overweight
or obese; clinicians
should offer or refer
patients with
abnormal blood
glucose to intensive
behavioral
counseling
interventions to
promote a healthful
diet and physical
activity
o Revised list of applicable
ICD-10 diagnosis codes;
expanded list of Additional
Diagnosis Codes to include:

Overweight: E66.3,
Z68.25, Z68.26, Z68.27,
Z68.28, and Z68.29

Obesity: E66.01,
E66.09, E66.1, E66.8,
E66.9, Z68.41, Z68.42,
Z68.43, Z68.44, and
Z68.45

Body Mass Index
30.0-39.9: Z68.30,
Z68.31, Z68.32, Z68.33,
Z68.34, Z68.35, Z68.36,
Z68.37, Z68.38, and
Z68.39

Body Mass Index 40.0
and Over: Z68.41,
Z68.42, Z68.43, Z68.44,
and Z68.45
o Revised preventive benefit
instructions; added age limit
of 40-70 years (ends on 71st
birthday)
High Blood Pressure in Adults
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Preventive Care
Services
(continued)
53
Effective Date
Oct. 1, 2016
Summary of Changes
– Screening
o Updated service
title/heading; previously
titled Screening for High
Blood Pressure
o Revised service description:

Removed December
2007 USPSTF ‘A’ rating

Added October 2015
USPSTF ‘A’ rating:
- The USPSTF
recommends
screening for high
blood pressure in
adults aged 18 years
or older
- The USPSTF
recommends
obtaining
measurements
outside of the clinical
setting for diagnostic
confirmation before
starting treatment
o Added list of applicable
codes for ambulatory blood
pressure measurement
(outside of a clinical setting):
 CPT codes: 93784,
93786, 93788, or 93790
 ICD-10 diagnosis code:
R03.0 (abnormal bloodpressure reading without
diagnosis of
hypertension)
o Updated preventive benefit
instructions; added language
to indicate coverage for
ambulatory blood pressure
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Preventive Care
Services
(continued)
Effective Date
Oct. 1, 2016
Summary of Changes
measurement (outside of a
clinical setting):

Applies to patients age
18 years and older

Is payable as preventive
when billed with the
listed diagnosis code
Coverage Rationale
Rhinoplasty and
Other Nasal
Surgeries
Sep. 1, 2016

Indications for Coverage
Some states require benefit coverage for services that UnitedHealthcare
considers cosmetic procedures, such as repair of external congenital
anomalies in the absence of a functional impairment. Please refer to the
member specific benefit plan document.

54
Reformatted and reorganized
policy; transferred content to
new template
Revised coverage rationale:
o Added coverage
guidelines/language to
indicate:

Rhinoplasty – Primary
(CPT codes 30410 and
30420) is considered
reconstructive and
medically necessary
when all of the following
criteria are present:
Prolonged, persistent
obstructed nasal
breathing due to
nasal bone and
septal deviation that
are the primary
causes of an
anatomic mechanical
nasal airway
obstruction; and
The nasal airway
obstruction cannot
be corrected by
septoplasty alone as
documented in the
medical record; and
Photos clearly
Medical Policy Update Bulletin: July 2016
Rhinoplasty-Primary (CPT Codes 30410, 30420)
Rhinoplasty-primary is considered reconstructive and medically
necessary when all of the following criteria are present:

Prolonged, persistent obstructed nasal breathing due to nasal bone and
septal deviation that are the primary causes of an anatomic mechanical
nasal airway obstruction, and

The nasal airway obstruction cannot be corrected by septoplasty alone as
documented in the medical record, and

Photos clearly document the nasal bone/septal deviation as the primary
cause of an anatomic mechanical nasal airway obstruction and are
consistent with the clinical exam, and

The proposed procedure is designed to correct the anatomic mechanical
nasal airway obstruction and relieve the nasal airway obstruction by
centralizing the nasal bony pyramid (30410) and also straightening the
septum (30420), and

One of the following is present:
o Nasal fracture with nasal bone displacement severe enough to cause
nasal airway obstruction, or
o Residual large cutaneous defect following resection of a malignancy
or nasal trauma, and

Nasal airway obstruction is causing significant symptoms (e.g., chronic
rhinosinusitis, difficulty breathing), and

Obstructive symptoms persist despite conservative management for 4
weeks or greater, which includes, where appropriate, nasal steroids or
immunotherapy.
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
55
Effective Date
Sep. 1, 2016
Summary of Changes
document the nasal
bone/septal
deviation as the
primary cause of an
anatomic mechanical
nasal airway
obstruction and are
consistent with the
clinical exam; and
The proposed
procedure is
designed to correct
the anatomic
mechanical nasal
airway obstruction
and relieve the nasal
airway obstruction
by centralizing the
nasal bony pyramid
(30410) and also
straightening the
septum (30420);
and
One of the following
is present:

Nasal fracture
with nasal bone
displacement
severe enough to
cause nasal
airway
obstruction; or

Residual large
cutaneous defect
following
resection of a
malignancy or
nasal trauma;
and
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Rhinoplasty-Tip (CPT Code 30400)
Rhinoplasty-tip is primarily cosmetic. However, it is considered
reconstructive and medically necessary when all of the following
criteria are present:

Prolonged, persistent obstructed nasal breathing due to tip drop that is
the primary cause of an anatomic mechanical nasal airway obstruction
(this code is usually cosmetic), and

Photos clearly document tip drop as the primary cause of an anatomic
mechanical nasal airway obstruction and are consistent with the clinical
exam (acute columellar-labial angle), and

The proposed procedure is designed to correct the anatomic mechanical
nasal airway obstruction and relieve the nasal airway obstruction by
lifting the nasal tip, and

Nasal airway obstruction is causing significant symptoms (e.g., chronic
rhinosinusitis, difficulty breathing), and

Obstructive symptoms persist despite conservative management for 4
weeks or greater, which includes, where appropriate, nasal steroids or
immunotherapy.
Rhinoplasty-Secondary (CPT Codes 30430, 30435, 30450)
Rhinoplasty-secondary is primarily cosmetic. However, it is
considered reconstructive and medically necessary when all of the
following criteria are present:

Required as treatment of a complication/residual deformity from primary
surgery performed to address a functional impairment when a
documented functional impairment persists due to the
complication/deformity (these codes are usually cosmetic), and

Photos clearly document the secondary deformity/complication as the
primary cause of an anatomic mechanical nasal airway obstruction and
are consistent with the clinical exam, and

The proposed procedure is designed to correct the anatomic mechanical
nasal airway obstruction and relieve the nasal airway obstruction by
correcting the deformity or treating the complication (these codes are
usually cosmetic), and

Nasal airway obstruction is causing significant symptoms (e.g., chronic
rhinosinusitis, difficulty breathing), and

Obstructive symptoms persist despite conservative management for 4
weeks or greater, which includes, where appropriate, nasal steroids or
immunotherapy.
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
56
Effective Date
Sep. 1, 2016
Summary of Changes
Nasal airway
obstruction is
causing significant
symptoms (e.g.,
chronic
rhinosinusitis,
difficulty breathing);
and
Obstructive
symptoms persist
despite conservative
management for 4
weeks or greater,
which includes,
where appropriate,
nasal steroids or
immunotherapy

Rhinoplasty – Tip (CPT
code 30400) is
primarily cosmetic;
however, it is considered
reconstructive and
medically necessary
when all of the following
criteria are present:
Prolonged, persistent
obstructed nasal
breathing due to tip
drop that is the
primary cause of an
anatomic mechanical
nasal airway
obstruction (this
code is usually
cosmetic); and
Photos clearly
document tip drop as
the primary cause of
an anatomic
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Rhinoplasty for Congenital Anomalies (CPT Codes 30460, 30462)
The following are considered reconstructive and medically necessary
when the following are present:

Rhinoplasty is considered reconstructive when performed for a nasal
deformity associated with congenital craniofacial anomalies including, but
not limited to Pierre Robin, Apert Syndrome, Fraser Syndrome, Binder
Syndrome, Goldenhar Syndrome, Nasal dermoids, Tessier Nasal Cleft
(most commonly #1) or associated with a cleft lip or cleft palate.
Repair of Nasal Vestibular Stenosis or Alar Collapse (CPT Code
30465)
Repair of nasal vestibular stenosis or alar collapse is considered
reconstructive and medically necessary when all of the following
criteria are present:

Prolonged, persistent obstructed nasal breathing due to internal and/or
external nasal valve compromise (see Definitions section of the policy),
and

Internal valve compromise due to collapse of the upper lateral cartilage
and/or external nasal valve compromise due to collapse of the alar
(lower lateral) cartilage resulting in an anatomic mechanical nasal airway
obstruction that is a primary contributing factor for obstructed nasal
breathing, and

Photos clearly document internal and/or external valve collapse as the
primary cause of an anatomic mechanical nasal airway obstruction and
are consistent with the clinical exam, and

Other causes have been eliminated as the primary cause of nasal
obstruction (e.g., sinusitis, allergic rhinitis, vasomotor rhinitis, nasal
polyposis, adenoid hypertrophy, nasopharyngeal masses, nasal septal
deviation, turbinate hypertrophy and choanal atresia).
Septal Dermatoplasty (CPT Code 30620)
Septal dermatoplasty is considered reconstructive when:

There is a documented functional impairment (e.g., Obstruction, pain or
bleeding) due to diseased nasal mucosa, and

The functional impairment will be eliminated by a skin graft.
Lysis Intranasal Synechia (CPT Code 30560)
Lysis intranasal synechia is considered reconstructive when:
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
57
Effective Date
Sep. 1, 2016
Summary of Changes
mechanical nasal
airway obstruction
and are consistent
with the clinical
exam (acute
columellar-labial
angle); and
The proposed
procedure is
designed to correct
the anatomic
mechanical nasal
airway obstruction
and relieve the nasal
airway obstruction
by lifting the nasal
tip; and
Nasal airway
obstruction is
causing significant
symptoms (e.g.,
chronic
rhinosinusitis,
difficulty breathing);
and
Obstructive
symptoms persist
despite conservative
management for 4
weeks or greater,
which includes,
where appropriate,
nasal steroids or
immunotherapy

Rhinoplasty –
Secondary (CPT codes
30430, 30435, and
30450) is primarily
cosmetic; however, it is
Medical Policy Update Bulletin: July 2016
Coverage Rationale

There is a documented functional impairment (e.g., obstruction, pain or
bleeding) due to intranasal synechia (adhesions/scar bands), and

The functional impairment will be eliminated by lysis of the synechia.
Rhinophyma (CPT Code 30120)
Rhinophyma is considered reconstructive and medically necessary
when all of the following criteria are present:

One of the following:
o Prolonged, persistent obstructed nasal breathing due to rhinophyma;
or
o Chronic infection or bleeding unresponsive to medical management
due to rhinophyma; and

Photos clearly document rhinophyma as the primary cause of an
anatomic mechanical nasal airway obstruction or chronic infection and
are consistent with the clinical exam, and

The proposed procedure is designed to correct the anatomic mechanical
nasal airway obstruction and relieve the nasal airway obstruction by
correcting the deformity or the proposed procedure is designed to
address the chronic infection.
Medical Necessity Plans: Please use the criteria above where applicable.
California Only: This is the mandated language for Reconstructive
Procedures - Reconstructive procedures to correct or repair abnormal
structures of the body caused by congenital defects, developmental
abnormalities, trauma, infection, tumors, or disease. Reconstructive
procedures include surgery or other procedures which are associated with an
Injury, Sickness or Congenital Anomaly. The primary result of the procedure
is not a changed or improved physical appearance for cosmetic purposes
only, but rather to improve function and/or create a normal appearance, to
the extent possible.
Documentation Requirements
Rhinoplasty or other nasal surgery documentation should include the
evaluation and management note for the date of service and the note for the
day the decision to perform surgery was made. The member’s medical record
must contain, and be available for review on request, the following
information:

Physician office notes
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
58
Effective Date
Sep. 1, 2016
Summary of Changes
considered
reconstructive and
medically necessary
when all of the following
criteria are present:
Required as
treatment of a
complication/residual
deformity from
primary surgery
performed to
address a functional
impairment when a
documented
functional
impairment persists
due to the
complication/deformi
ty (these codes are
usually cosmetic);
and
Photos clearly
document the
secondary
deformity/complicati
on as the primary
cause of an anatomic
mechanical nasal
airway obstruction
and are consistent
with the clinical
exam; and
The proposed
procedure is
designed to correct
the anatomic
mechanical nasal
airway obstruction
and relieve the nasal
Medical Policy Update Bulletin: July 2016
Coverage Rationale

Radiologic imaging if done

Photographs that document the nasal deformity
Coverage Limitations and Exclusions
Cosmetic Procedures are excluded from coverage, including but not limited
to:

Procedures that correct an anatomical Congenital Anomaly without
improving or restoring physiologic function are considered Cosmetic
Procedures. The fact that a Covered Person may suffer psychological
consequences or socially avoidant behavior as a result of an Injury,
Sickness or Congenital Anomaly does not classify surgery (or other
procedures done to relieve such consequences or behavior) as a
reconstructive procedure.

Rhinoplasty, unless rhinoplasty criteria above are met

Any procedure that does not meet the reconstructive criteria

Rhinoplasty procedures performed to improve appearance (check the
member specific benefit plan document)
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
59
Effective Date
Sep. 1, 2016
Summary of Changes
airway obstruction
by correcting the
deformity or treating
the complication
(these codes are
usually cosmetic);
and
Nasal airway
obstruction is
causing significant
symptoms (e.g.,
chronic
rhinosinusitis,
difficulty breathing);
and
Obstructive
symptoms persist
despite conservative
management for 4
weeks or greater,
which includes,
where appropriate,
nasal steroids or
immunotherapy

Rhinophyma (CPT
code 30120) is
considered
reconstructive and
medically necessary
when all of the following
criteria are present:
One of the following:

Prolonged,
persistent
obstructed nasal
breathing due to
rhinophyma; or

Chronic infection
or bleeding
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
60
Effective Date
Sep. 1, 2016
Summary of Changes
unresponsive to
medical
management
due to
rhinophyma; and
Photos clearly
document
rhinophyma as the
primary cause of an
anatomic mechanical
nasal airway
obstruction or
chronic infection and
are consistent with
the clinical exam;
and
The proposed
procedure is
designed to correct
the anatomic
mechanical nasal
airway obstruction
and relieve the nasal
airway obstruction
by correcting the
deformity or the
proposed procedure
is designed to
address the chronic
infection
 Updated coverage guidelines
for;

Rhinoplasty for
Congenital Anomalies
(30460 and 30462):
- Modified service
specific content
heading to include
applicable CPT codes
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
61
Effective Date
Sep. 1, 2016
Summary of Changes
(30460 and 30462)

Repair of Nasal
Vestibular Stenosis or
Alar Collapse (30465):
- Modified service
specific content
heading:

Retitled heading;
previously titled
“Rhinoplasty for
Nasal Vestibular
Stenosis or Alar
Collapse”

Added applicable
CPT code
(30465)
- Modified/expanded
coverage criteria:

Added criterion
requiring photos
clearly
documenting
internal and/or
external valve
collapse as the
primary cause of
an anatomic
mechanical nasal
airway
obstruction and
are consistent
with the clinical
exam

Added nasal
septal deviation,
turbinate
hypertrophy and
choanal atresia
to the list of
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
62
Effective Date
Sep. 1, 2016
Summary of Changes
conditions that
must be
eliminated as the
primary cause of
nasal obstruction
o Updated documentation
requirements; added
language to clarify the
member’s medical record
must contain:

Radiologic imaging, if
done

Photographs that
document the nasal
deformity

Updated and reformatted list of
applicable CPT codes:
 Added service specific
content heading for:

Lysis Intranasal
Synechia

Septal Dermatoplasty
 Retitled service specific
content heading for:

Rhinoplasty (previously
titled “Rhinoplasty
Repair”)

Repair of Vestibular
Stenosis (previously
titled “Surgical Repair of
Vestibular Stenosis”)
o Added list of applicable
codes for Rhinophyma:
30120
o Removed list of
Miscellaneous Codes: 30540
and 30545

Updated definitions; added
definition of:
Medical Policy Update Bulletin: July 2016
Coverage Rationale
Coverage Determination Guideline (CDG) Updates
REVISED
Policy Title
Rhinoplasty and
Other Nasal
Surgeries
(continued)
63
Effective Date
Sep. 1, 2016
Summary of Changes
o Mechanical nasal airway
obstruction
o Prolonged, persistent nasal
airway obstruction
o Rhinitis medicamentosa (RM)

Updated supporting information
to reflect the most current
references
Medical Policy Update Bulletin: July 2016
Coverage Rationale