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

July 2016

medical policy update bulletin Medical Policy, Drug Policy & Coverage Determination Guideline Updates

2 Medical Policy Update Bulletin: July 2016

Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) Updates

Overview

Tips for using the Medical Policy Update Bulletin:

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

directed to the corresponding policy update summary.

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

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

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review

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

device

Updated

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

to the clinical coverage criteria or documentation review requirements;

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

list(s) of applicable codes may have been updated

Revised

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

the clinical coverage criteria and/or documentation review requirements

Replaced

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

Retired

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

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

necessary and are therefore not excluded as unproven/not medically

necessary services, unless coverage guidelines or criteria are otherwise

documented in another policy

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

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

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

applicable federal or state regulatory requirements. Additionally,

UnitedHealthcare reserves the right to review the clinical evidence

supporting the safety and effectiveness of a medical technology prior to

rendering a coverage determination.

This bulletin provides complete details on 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.

3 Medical Policy Update Bulletin: July 2016

Medical Policy, Drug Policy, and Coverage Determination Guideline (CDG) Updates

In This Issue

Medical Policy Updates Page

UPDATED

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

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

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

Mifeprex® (Mifepristone, RU-486) - Effective Aug. 1, 2016 ................................................................................................................................... 38

4 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

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

5 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Apheresis

Jul. 1, 2016

Reformatted and reorganized policy; transferred content to

new template Updated/clarified coverage

rationale: o Replaced language indicating

“therapeutic apheresis is proven and medically

necessary for the listed diagnoses” with “therapeutic apheresis is proven and medically necessary for treating or managing the listed conditions/diagnoses”

o Replaced language indicating

“therapeutic apheresis including plasma exchange, plasmapheresis, or

photopheresis is unproven and not medically necessary for the listed indications” with “therapeutic apheresis

including plasma exchange, plasmapheresis, or photopheresis is unproven and not medically necessary for treating or managing the conditions/diagnoses,

including but not limited to, those listed”

o Replaced language indicating “apheresis is first-line therapy for the listed conditions” with “apheresis is first-line therapy when

treating or managing the listed conditions/diagnoses”

o Replaced language indicating “apheresis is proven and

Therapeutic apheresis is proven and medically necessary for treating or managing the following conditions/diagnoses:

ABO incompatible heart transplantation in children less than 40 months of age (plasma exchange)

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

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

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

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

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

(photopheresis) Chronic inflammatory demyelinating polyneuropathy (plasma exchange) Cryoglobulinemia (plasma exchange)

Cutaneous T-cell lymphoma; mycosis fungoides; 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)

6 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Apheresis (continued)

Jul. 1, 2016

medically necessary for persons who are refractory to or intolerant of standard

therapy for the listed conditions where apheresis is second-line therapy” with

“apheresis is proven and medically necessary for persons who are refractory to or intolerant of standard

therapy for the listed conditions/diagnoses where apheresis is second-line therapy”

Updated supporting information to reflect the most current

clinical evidence and references

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, non-

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

Hereditary hemochromatosis Hemolytic uremic syndrome High density lipoprotein (HDL) delipidation and plasma reinfusion Hyperleukocytosis, prophylaxis Hypertriglyceridemic pancreatitis Hyperviscosity in monoclonal gammopathies, prophylaxis for rituximab

IgG/IgA or IgM type of paraproteinemic polyneuropathy treated with immunoadsorption

Immune thrombocytopenic purpura

7 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Apheresis (continued)

Jul. 1, 2016

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 transplant-

associated Thyroid storm Wilson’s disease, fulminant There is insufficient evidence to conclude that apheresis, plasma exchange, plasmapheresis, immunoadsorption, or photopheresis is beneficial for health

outcomes such as decreased morbidity and mortality rates in patients with disorders other than those listed as proven.

8 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Apheresis (continued)

Jul. 1, 2016

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

9 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Apheresis (continued)

Jul. 1, 2016

(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 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

Bronchial thermoplasty is unproven and not medically necessary for

treating asthma. There is insufficient and low quality evidence regarding the use of bronchial thermoplasty in patients with severe asthma, who are resistant to standard

therapies. Additional well-designed studies are needed to identify the long-term safety and efficacy of bronchial thermoplasty for the treatment of severe asthma.

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.

Reformatted and reorganized policy; transferred content to new template

Updated list of applicable CPT codes; modified “coding

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 well-designed randomized controlled trials are necessary to establish the relative safety and efficacy of the embolization procedure as a treatment of pelvic congestion syndrome.

10 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Embolization of the Ovarian and Iliac Veins for Pelvic

Congestion Syndrome (continued)

July 1, 2016 Aug. 1, 2016*

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

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

11 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Home Traction Therapy (continued)

Jul. 1, 2016 Updated supporting information to reflect the most current clinical evidence and references;

no change to coverage rationale or list of applicable codes

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 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

Port-Wine Stains and Cutaneous Hemangiomata

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

Light and laser therapy including intense pulsed light are unproven and not medically necessary for treating rosacea and rhinophyma.

The quantity and quality of the evidence is insufficient to recommend light and laser treatment for the treatment of rosacea and rhinophyma. The quality of evidence is limited. Additional research is needed to determine efficacy and safety and to clarify patient selection and treatment parameters. Acne Vulgaris

Light and laser therapy including light phototherapy, photodynamic therapy, intense pulsed light, and pulsed dye laser are unproven and not medically necessary for treating active acne vulgaris.

There is insufficient evidence to recommend the use of light and laser therapy for the treatment acne vulgaris. Studies evaluating light and laser therapy for acne typically are short term, lack controls or the patient serves as their own control, have small sample sizes, and do not compare laser therapy with standard acne treatment. Well-designed studies are necessary to clarify the role of light and laser therapy for acne. Pilonidal Sinus Disease

Laser hair removal is unproven and not medically necessary for

treating pilonidal sinus disease. There is insufficient evidence to conclude that laser hair removal is effective for treating pilonidal sinus disease. Most of the studies regarding this treatment were small and uncontrolled. Additional well-designed controlled trials are needed to determine the efficacy of laser hair removal for pilonidal disease.

12 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Meniscus Implant and Allograft

Jul. 1, 2016

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

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.

13 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Meniscus Implant and Allograft (continued)

Jul. 1, 2016 references

Molecular Profiling to Guide Cancer

Treatment

Jul. 1, 2016

Reformatted and reorganized policy; transferred content to

new template Updated/clarified coverage

rationale:

o Replaced language indicating “molecular profiling using multiplex or next generation sequencing (NGS) technology is proven and medically necessary to guide

systemic chemotherapy in patients with metastatic stage IV non-small cell lung

cancer (NSCLC) when used to test only for epidermal growth factor receptor (EGFR) mutations, human

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

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 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/CategoryListing.htm. (Accessed April 21, 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.

14 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Molecular Profiling to Guide Cancer Treatment

(continued)

Jul. 1, 2016 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

Motorized Spinal Traction

Jul. 1, 2016

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

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)

15 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Motorized Spinal Traction (continued)

Jul. 1, 2016 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

Umbilical Cord Blood Harvesting

and Storage for Future Use

Jul. 1, 2016 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

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. For additional information and coverage of umbilical cord blood stem cell transplantation, please refer to the UnitedHealth Group Transplant Review Guidelines.

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Aug. 1, 2016

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

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).

16 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Continuous Glucose Monitoring and Insulin Delivery for

Managing Diabetes (continued)

Aug. 1, 2016

“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

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.

17 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Continuous Glucose Monitoring and Insulin Delivery for

Managing Diabetes (continued)

Aug. 1, 2016 Long-term continuous glucose monitoring for personal use at home 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. 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)

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

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 non-

invasive (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 first-degree or second-degree female relatives or female relatives surviving

18 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Genetic Testing for Hereditary Breast and/or Ovarian

Cancer Syndrome (HBOC) (continued)

Aug. 1, 2016

(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

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

19 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Genetic Testing for Hereditary Breast and/or Ovarian

Cancer Syndrome (HBOC) (continued)

Aug. 1, 2016

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

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

20 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Genetic Testing for Hereditary Breast and/or Ovarian

Cancer Syndrome (HBOC) (continued)

Aug. 1, 2016

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. 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

21 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Genetic Testing for Hereditary Breast and/or Ovarian

Cancer Syndrome (HBOC) (continued)

Aug. 1, 2016

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

22 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Genetic Testing for Hereditary Breast and/or Ovarian

Cancer Syndrome (HBOC) (continued)

Aug. 1, 2016

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

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

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

23 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Mechanical Stretching and Continuous Passive

Motion Devices (continued)

Aug. 1, 2016 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”

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 post-operative 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

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

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

24 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Obstructive Sleep Apnea Treatment (continued)

Oct. 1, 2016

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

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

25 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Obstructive Sleep Apnea Treatment (continued)

Oct. 1, 2016 implants benefit patients with mild to moderate OSA. However, the magnitude of the benefits has been small; the largest randomized controlled trial (RCT) found that average OSA worsened in spite of treatment; and the

available studies involved ≤ 1 year of patient monitoring after treatment. Additional studies are needed to determine the role of palatal implants in the management of OSA

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

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

established procedures are necessary.

There is insufficient evidence to support the safety, efficacy and long-term outcomes of hypoglossal nerve stimulation in the treatment of OSA. The optimal patient selection criteria for the use of hypoglossal nerve stimulation have not been defined. Randomized controlled trials or comparative effectiveness trials with long-term follow-up, comparing hypoglossal nerve

stimulation to established procedures are necessary to evaluate the effectiveness of this technology. There is insufficient evidence to support the efficacy and long-term outcomes of radiofrequency ablation of the tongue or soft palate in the treatment of OSA. Optimal patient selection criteria have not been defined. Large controlled studies or comparative effectiveness trials with long-term follow-

up comparing radiofrequency ablation to established procedures are necessary. Follow-up polysomnography should be performed following surgery to evaluate response to treatment (Kushida et al., 2006; Ferguson et al., 2006). Refer to the Medical Policy titled Attended Polysomnography for

Evaluation of Sleep Disorders for further information.

26 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Preterm Labor Management

Aug. 1, 2016

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 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

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.

27 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Preterm Labor Management (continued)

Aug. 1, 2016 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

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: SG-MS (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

28 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Transcatheter Heart Valve Procedures

(continued)

Sep. 1, 2016

warnings, and precautions” Updated supporting information

to reflect the most current

clinical evidence, FDA and CMS information, and references

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 long-term efficacy of catheter-delivered mitral valve leaflet repair devices for

treating mitral regurgitation. Further results from prospective, randomized controlled trials are needed to determine device durability and the ideal candidates for the procedure. 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

29 Medical Policy Update Bulletin: July 2016

Medical Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Transcatheter Heart Valve Procedures

(continued)

Sep. 1, 2016 investigational due to lack of FDA approval. There is insufficient evidence in the clinical literature demonstrating the long-term 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 long-term efficacy of ViV procedures. Further results from prospective studies are

needed to determine the ideal candidates for this procedure.

30 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Benlysta® (Belimumab)

Jul. 1, 2016 Updated coverage rationale; clarified terminology:

o Replaced reference to “anti-dsDNA” with “anti-double-stranded DNA (anti-dsDNA)”

Updated supporting information

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

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 self-administered 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-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf.

(Accessed April 1, 2016)

Oncology Medication Clinical Coverage Policy

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

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

31 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Oncology Medication Clinical Coverage Policy

(continued)

Jul. 1, 2016

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”

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, high-powered randomized clinical trials or meta-analyses), and the panel has reached uniform consensus that the recommendation is indicated. In this

context, uniform means near unanimous positive support with some possible neutral positions.

Category 2A: The recommendation is based on lower level evidence, but

despite the absence of higher level studies, there is uniform consensus that the recommendation is appropriate. Lower level evidence is interpreted broadly, and runs the gamut from phase II to large cohort studies to case series to individual practitioner experience. Importantly, in many instances, the retrospective studies are derived from clinical experience of treating

32 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Oncology Medication Clinical Coverage Policy

(continued)

Jul. 1, 2016 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®)

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

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;

33 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Repository Corticotropin Injection (H.P.

Acthar Gel®) (continued)

Jul. 1, 2016

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.

34 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Repository Corticotropin Injection (H.P.

Acthar Gel®) (continued)

Jul. 1, 2016 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. See the Medicare Benefit Policy

Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf.

(Accessed March 30, 2016)

Rituxan®

(Rituximab)

Jul. 1, 2016

Routine review; no change to

coverage rationale or lists of applicable codes

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. Rituxan (rituximab) is proven for the treatment of:

1. Immune thrombocytopenic purpura (ITP)

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

2. Autoimmune mucocutaneous blistering diseases

3. 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

4. Autoimmune hemolytic anemia, including chronic cold agglutinin disease

5. Rituxan is proven and medically necessary for the treatment of

35 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rituxan®

(Rituximab) (continued)

Jul. 1, 2016

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®).

36 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rituxan®

(Rituximab) (continued)

Jul. 1, 2016 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-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf.

(Accessed March 29, 2016)

Soliris®

(Eculizumab)

Jul. 1, 2016

Routine review; no change to

coverage rationale or lists of applicable codes

Proven

Atypical Hemolytic Uremic Syndrome (aHUS) Eculizumab is indicated for the treatment of atypical hemolytic uremic

syndrome (aHUS). 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

37 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Soliris® (Eculizumab) (continued)

Jul. 1, 2016 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 time-dependent 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

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

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

38 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Vaccines (continued)

Jul. 1, 2016 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

MMWR. 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-and-Guidance/Guidance/Manuals/downloads/bp102c15.pdf.

(Accessed April 4, 2016)

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Mifeprex® (Mifepristone, RU-

486)

Aug. 1, 2016

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

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.

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

39 Medical Policy Update Bulletin: July 2016

Drug and Biologics Policy Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Mifeprex® (Mifepristone, RU-486)

(continued)

Aug. 1, 2016 clinical evidence, FDA and CMS information, and references

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-and-

Guidance/Guidance/Manuals/downloads/bp102c15.pdf. (Accessed April 4, 2016)

40 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Breast Reconstruction Post

Mastectomy

Sep. 1, 2016

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

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

41 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Breast Reconstruction Post Mastectomy

(continued)

Sep. 1, 2016

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 post-mastectomy 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.

42 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Breast Reconstruction Post Mastectomy

(continued)

Sep. 1, 2016 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.

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Breast Reduction Surgery

Aug. 1, 2016

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

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.

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

43 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Breast Reduction Surgery (continued)

Aug. 1, 2016

review” with “the [noted] documentation should be available for review”

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

44 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Breast Reduction Surgery (continued)

Aug. 1, 2016

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

45 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Breast Reduction Surgery (continued)

Aug. 1, 2016

or BSA = (W 0.425 x H 0.725) x 0.007184 (weight is in kilograms and height is in centimeters)

Modified Schnur Nomogram Chart

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

1.35 127 199

1.40 139 218

1.45 152 238

1.50 166 260

1.55 181 284

1.60 198 310

1.65 216 338

1.70 236 370

1.75 258 404

1.80 282 441

1.85 308 482

1.90 336 527

1.95 367 575

2.00 401 628

2.05 439 687

2.10 479 750

2.15 523 819

2.20 572 895

2.25 625 978

2.30 682 1,068

2.35 745 1,167

2.40 814 1,275

2.45 890 1,393

2.50 972 1,522

2.55 1,062 1,662

Cosmetic and Reconstructive Procedures

Sep. 1, 2016

Reformatted and reorganized policy; transferred content to new template

Revised coverage rationale/criteria for a procedure

to be considered reconstructive

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

46 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Cosmetic and Reconstructive Procedures

(continued)

Sep. 1, 2016

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

reconstructive; although no functional impairment may be documented for microtia,

this has been deemed reconstructive surgery

Updated 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”

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.

47 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Cosmetic and Reconstructive Procedures

(continued)

Sep. 1, 2016 o Removed definition of: Abdominoplasty Blepharoplasty

Brow ptosis Breast reduction

mammoplasty

Cleft lip & palate Mastectomy Panniculectomy Panniculus

Ptosis of eyelids Visual field

Pectus Deformity Repair

Sep. 1, 2016

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

Indications for Coverage

Surgical repair of pectus excavatum is considered reconstructive and medically necessary when the following criteria has been met:

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

04.20.16 – Obtained email clarification from Dr. Lincoln as to the wording of the bullet points for Pectus Excavatum. 04.21.16 – Wendy reviewed. She agrees with Dr. Lincoln’s updates and that the current references

support this update.

48 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Pectus Deformity Repair (continued)

Sep. 1, 2016 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

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

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

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. 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

49 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Private Duty Nursing Services (PDN)

(continued)

Aug. 1, 2016

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

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

50 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Private Duty Nursing Services (PDN)

(continued)

Aug. 1, 2016

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;

51 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Private Duty Nursing Services (PDN)

(continued)

Aug. 1, 2016 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

Preventive Care

Services

Oct. 1, 2016

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

Refer to the policy for complete details on the coverage guidelines for

Preventive Care Services.

52 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Preventive Care Services (continued)

Oct. 1, 2016

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

53 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Preventive Care Services (continued)

Oct. 1, 2016

– 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 blood-pressure reading without diagnosis of hypertension)

o Updated preventive benefit instructions; added language to indicate coverage for

ambulatory blood pressure

54 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Preventive Care Services (continued)

Oct. 1, 2016 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

Rhinoplasty and

Other Nasal Surgeries

Sep. 1, 2016

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

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. 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.

55 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

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

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.

56 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

- 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

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:

57 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

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

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

58 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

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/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

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)

59 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

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

60 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

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

61 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

(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

62 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

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:

63 Medical Policy Update Bulletin: July 2016

Coverage Determination Guideline (CDG) Updates

REVISED

Policy Title Effective Date Summary of Changes Coverage Rationale

Rhinoplasty and Other Nasal Surgeries

(continued)

Sep. 1, 2016

o Mechanical nasal airway obstruction

o Prolonged, persistent nasal

airway obstruction o Rhinitis medicamentosa (RM)

Updated supporting information

to reflect the most current references