october 2019 medical policy update bulletin · in this issue 3 medical policy update bulletin:...

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, Medical Benefit Drug Policy, Coverage Determination Guideline, Utilization Review Guideline, and Quality of Care Guideline updates.* *Where information in this bulletin conflicts with applicable state and/or federal law, UnitedHealthcare follows such applicable federal and/or state law.

October 2019

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

Updated Oct. 4, 2019: Implementation of the changes described in this bulletin for the following Medical Benefit Drug Policies has been delayed until further notice: Page 21: Cimzia® (Certolizumab Pegol) (New)

Page 26: Actemra® (Tocilizumab) Injection for Intravenous Infusion (Revised) Page 41: Orencia® (Abatacept) Injection for Intravenous Infusion (Revised) Page 43: Simponi Aria® (Golimumab) Injection for Intravenous Infusion (Revised)

Updated Oct. 8, 2019: Implementation of the changes described in this bulletin for the following Clinical Policy has been delayed until further notice: Page 27: Benlysta® (Belimumab) (Revised)

2 Medical Policy Update Bulletin: October 2019

Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline 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 health service (e.g., test, drug,

device or procedure)

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 health service(s) addressed 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 health service 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, Medical Benefit Drug Policy, Coverage Determination

Guideline (CDG), Utilization Review Guideline (URG), and/or

Quality of Care Guideline (QOCG) updates. The inclusion of a

health service (e.g., test, drug, device 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 health service. 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.

The complete library of UnitedHealthcare Medical

Policies, Medical Benefit Drug Policies, CDGs, URGs, and

QOCGs is available at UHCprovider.com > Policies and

Protocols > Commercial Policies > Medical & Drug

Policies and Coverage Determination Guidelines.

https://www.uhcprovider.com/en/policies-protocols/commercial-policies/commercial-medical-drug-policies.html





In This Issue

Take Note

QUARTERLY CPT® AND HCPCS CODE UPDATES

Effective Oct. 1, 2019, all applicable Medical Policies and Medical Benefit Drug Policies have been modified to reflect the quarterly Current Procedural Terminology (CPT®) and Healthcare Common Procedure Coding System (HCPCS) code additions, revisions, and deletions.

Medical Policy Updates Page

UPDATED

Electric Tumor Treatment Field Therapy – Effective Nov. 1, 2019 ......................................................................................................................... 5 Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions – Effective Oct. 1, 2019 ........................................................... 5 Skin and Soft Tissue Substitutes – Effective Oct. 1, 2019 .................................................................................................................................... 5

REVISED

Apheresis – Effective Nov. 1, 2019 ................................................................................................................................................................... 5 Bariatric Surgery – Effective Dec. 1, 2019 ....................................................................................................................................................... 10 Epidural Steroid and Facet Injections for Spinal Pain – Effective Dec. 1, 2019 ....................................................................................................... 12 Genetic Testing for Hereditary Cancer – Effective Oct. 1, 2019 ........................................................................................................................... 14 Omnibus Codes – Effective Dec. 1, 2019 ......................................................................................................................................................... 17 Vagus and External Trigeminal Nerve Stimulation – Effective Dec. 1, 2019 .......................................................................................................... 18

Medical Benefit Drug Policy Updates

NEW

Cimzia® (Certolizumab Pegol) – Effective Oct. 1, 2019 TBD ............................................................................................................................... 21 Krystexxa® (Pegloticase) – Effective Oct. 1, 2019 ............................................................................................................................................. 24

UPDATED

Complement Inhibitors (Soliris® & Ultomiris™) – Effective Oct. 1, 2019 ............................................................................................................... 25 Evenity™ (Romosozumab-Aqqg) – Effective Oct. 1, 2019 .................................................................................................................................. 26 Gamifant™ (Emapalumab-Lzsg) – Effective Oct. 1, 2019 ................................................................................................................................... 26 Onpattro™ (Patisiran) – Effective Oct. 1, 2019 ................................................................................................................................................ 26

REVISED

Actemra® (Tocilizumab) Injection for Intravenous Infusion – Effective Oct. 1, 2019 TBD ........................................................................................ 26 Benlysta® (Belimumab) – Effective Oct. 1, 2019 TBD ........................................................................................................................................ 27 Clotting Factors, Coagulant Blood Products & Other Hemostatics – Effective Oct. 1, 2019 ....................................................................................... 28



In This Issue

Infliximab (Remicade®, Inflectra™, Renflexis™) – Effective Oct. 1, 2019 ............................................................................................................. 28 Ketalar® (Ketamine) and Spravato™ (Esketamine) – Effective Oct. 1, 2019 ......................................................................................................... 33 Maximum Dosage – Effective Oct. 1, 2019 ...................................................................................................................................................... 36 Oncology Medication Clinical Coverage – Effective Oct. 1, 2019 .......................................................................................................................... 38 Orencia® (Abatacept) Injection for Intravenous Infusion – Effective Oct. 1, 2019 TBD ........................................................................................... 41 Review at Launch Medication List – Effective Oct. 1, 2019 ................................................................................................................................. 42 Self-Administered Medications List – Effective Oct. 1, 2019 ............................................................................................................................... 43 Simponi Aria® (Golimumab) Injection for Intravenous Infusion – Effective Oct. 1, 2019 TBD .................................................................................. 43 Sodium Hyaluronate – Effective Oct. 1, 2019 ................................................................................................................................................... 44 Stelara® (Ustekinumab) – Effective Oct. 1, 2019 .............................................................................................................................................. 47

Coverage Determination Guideline (CDG) Updates

REVISED

Preventive Care Services – Effective Dec. 1, 2019 ............................................................................................................................................ 51


Medical Policy Updates

Policy Title Effective Date Summary of Changes

UPDATED

Electric Tumor

Treatment Field Therapy

Nov. 1, 2019 Template Update

Added Documentation Requirements section

Coverage Rationale Replaced language indicating “the use of devices to generate electric tumor treatment fields (TTF) is considered

investigational, unproven, and not medically necessary when the criteria [in the policy] are not met and for all

other indications [not listed in the policy]” with “the use of devices to generate electric tumor treatment fields (TTF) is unproven and not medically necessary when the criteria [in the policy] are not met and for all other indications [not listed in the policy]”

Definitions Updated definition of “Supratentorial”

Applicable Codes

Added HCPCS code A4555

Supporting Information Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect the most current

information

Molecular Oncology

Testing for Cancer Diagnosis, Prognosis, and

Treatment Decisions

Oct. 1, 2019 Applicable Codes

Updated list of applicable CPT codes to reflect quarterly code edits; added 0113U and 0118U

Skin and Soft Tissue Substitutes

Oct. 1, 2019 Applicable Codes Updated list of applicable HCPCS codes to reflect quarterly code edits; revised description for Q4122, Q4165,

and Q4184

Policy Title Effective Date Summary of Changes Coverage Rationale

REVISED

Apheresis

Nov. 1, 2019

Coverage Rationale Revised list of

conditions/diagnoses for which

therapeutic apheresis is proven and medically necessary: o Added:

Cryoglobulinemia

(second line therapy) Hypertriglyceridemic

Therapeutic apheresis is proven and medically necessary for treating or managing the following conditions/diagnoses: Acute inflammatory demyelinating polyneuropathy (Guillain-Barré

syndrome), primary treatment Acute liver failure (requiring High Volume Plasma Exchange) ANCA-associated rapidly progressive glomerulonephritis (Granulomatosis

with polyangiitis; and Microscopic Polyangiitis)

o Dialysis dependent o Diffuse alveolar hemorrhage (DAH)




REVISED

Apheresis

(continued)

Nov. 1, 2019

pancreatitis, severe

Major hematopoietic stem cell transplant, ABO incompatible, second line therapy

- HPC(M) - HPC(A)

Myeloma cast

nephropathy (second line therapy)

Neuromyelitis optica

spectrum disorders (Devic’s syndrome), relapse (second line therapy)

Renal transplantation, ABO incompatible

(second line therapy)

- Antibody mediated rejection

Voltage gated potassium

channel antibodies-related conditions

o Removed: ABO incompatible major

hematopoietic stem cell/bone marrow transplant (only as

second line therapy) ABO incompatible kidney

transplantation (only as

second line therapy) - Antibody mediated

rejection, living donor (LD)

desensitization - A²/A²B into B,

deceased donor

Age-related macular

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

o Dialysis independent o DAH

Cardiac transplantation, second line therapy o Recurrent rejection

o Desensitization Chronic inflammatory demyelinating polyneuropathy Cryoglobulinemia, second line therapy

Cutaneous T-cell lymphoma; mycosis fungoides; Sezary syndrome, erythrodermic

Familial hypercholesterolemia

o Homozygous o Heterozygous, second line therapy

Focal segmental glomerulosclerosis, recurrent in transplanted kidney, second line therapy

Graft-versus-host disease o Acute

o Chronic, second line therapy

Heart transplantation in children less than 40 months of age, ABO incompatible, second line therapy

Hereditary hemochromatosis

Hyperlipoproteinemia Hypertriglyceridemic pancreatitis, severe Hyperviscosity in hypergammaglobulinemia Idiopathic dilated cardiomyopathy, NYHA class II-IV, via IA

Inflammatory bowel disease, via adsorptive cytapheresis Liver transplantation, ABO incompatible

o Desensitized ABOi

o Living donor Lung transplantation, bronchiolitis obliterans syndrome Major hematopoietic stem cell transplant, ABO incompatible, second line

therapy o HPC(M) o HPC(A)

Multiple sclerosis, second line therapy

o Acute CNS inflammatory, demyelinating o Relapsing form with steroid resistant exacerbations

Myasthenia gravis, acute

Myeloma cast nephropathy, second line therapy




REVISED

Apheresis

(continued)

Nov. 1, 2019

degeneration, dry

Coagulation factor inhibitors, autoantibody via immunoadsorption (IA)

Hyperleukocytosis, symptomatic

Systemic lupus

erythematosus nephritis o Replaced:

“ABO incompatible liver

transplantation, desensitized ABOi, deceased donor” with “liver transplantation,

ABO incompatible: desensitized ABOi, living

donor”

“Graft-versus-host disease: acute or chronic, skin and non-

skin” with “graft-versus-host disease: acute or chronic”

“Hyperviscosity in

monoclonal gammopathies” with “hyperviscosity in

hypergammaglobulinemia”

“Myasthenia gravis” with

“myasthenia gravis, acute”

“Sickle cell disease: primary or secondary

stroke prevention” with “sickle cell disease:

stroke prevention”

“Vasculitis: Behçet’s

Neuromyelitis optica spectrum disorders (Devic’s syndrome), acute or

relapse, second line therapy N-methyl D-aspartate receptor antibody encephalitis Paraproteinemic polyneuropathies via Therapeutic Plasma Exchange

(TPE)

o Anti-MAG o Multifocal motor o IgG/IgA

o IgM Pediatric autoimmune neuropsychiatric disorders associated with

streptococcal infections (PANDAS exacerbation)

Peripheral vascular diseases Polycythemia vera; erythrocytosis Progressive multifocal leukoencephalopathy associated with natalizumab Pruritus due to hepatobiliary diseases

Renal transplantation, ABO compatible o Antibody mediated rejection

o Desensitization, living donor

Renal transplantation, ABO incompatible, second line therapy o Antibody mediated rejection

Rheumatoid arthritis, refractory, second line therapy

Sickle cell disease o Acute stroke or multiorgan failure o Acute chest syndrome, severe, second line therapy o Stroke prevention

o Prevention of transfusional iron overload Thrombotic microangiopathy, complement mediated

o MCP mutations

Thrombotic microangiopathy, Shiga toxin mediated o Absence of severe neurological symptoms

Thrombotic thrombocytopenic purpura

Vasculitis o Behcet’s disease (adsorptive cytapheresis) o Idiopathic PAN (TPE)

Voltage gated potassium channel antibodies-related conditions

Wilson’s disease, fulminant

Due to insufficient evidence of efficacy, therapeutic apheresis

including plasma exchange, plasmapheresis, or photopheresis is




REVISED

Apheresis

(continued)

Nov. 1, 2019

disease (adsorption

granulocytapheresis), EGPA (TPE)” with “Vasculitis: Behçet’s disease (adsorptive

cytapheresis)” o Added language to indicate

therapeutic apheresis is

proven and medically necessary for the following only as second line therapy:

Cardiac transplantation Multiple sclerosis: acute

CNS inflammatory, demyelinating

Revised list of conditions/diagnoses for which

therapeutic apheresis is

unproven and not medically necessary: o Added:

Age related macular degeneration

Liver transplantation - ABO incompatible

- Antibody mediated rejection

o Removed:

ABO incompatible liver transplantation, antibody mediated rejection

Cryoglobulinemia Myeloma cast

nephropathy Prevention of RhD

alloimmunization after RBC exposure

Voltage gated potassium

channel antibodies

unproven and not medically necessary for treating or managing the

following conditions/diagnoses, including but not limited to: Acute disseminated encephalomyelitis Acute inflammatory demyelinating polyneuropathy (Guillain-Barré

syndrome), after IVIG

Age related macular degeneration Amyloidosis, systemic Amyotrophic lateral sclerosis

ANCA-associated rapidly progressive glomerulonephritis, dialysis independent (Granulomatosis with polyangiitis; and Microscopic Polyangiitis)

Anti-glomerular basement membrane disease, dialysis dependent, without DAH (Goodpasture’s syndrome)

Aplastic anemia; pure red cell aplasia Atopic (neuro-) dermatitis (atopic eczema), recalcitrant

Autoimmune hemolytic anemia; warm autoimmune hemolytic anemia (WAIHA); cold agglutinin disease

Babesiosis

Burn shock resuscitation Cardiac neonatal lupus Cardiac transplantation

o Antibody mediated rejection o Rejection prophylaxis

Catastrophic antiphospholipid syndrome Chronic focal encephalitis (Rasmussen’s encephalitis)

Coagulation factor inhibitors Complex regional pain syndrome Cutaneous T-cell lymphoma; mycosis fungoides; Sézary syndrome, non-

erythrodermic Dermatomyositis/polymyositis Erythropoietic porphyria, liver disease

Focal segmental glomerulosclerosis, native kidney, steroid resistant Hashimoto’s encephalopathy HELLP syndrome Hematopoietic stem cell transplantation

o HLA desensitized o Major/minor ABO incompatibility with pure RBD aplasia

o Minor HPC(A)

Hemolytic uremic syndrome




REVISED

Apheresis

(continued)

Nov. 1, 2019

o Replaced:

“Coagulation factor inhibitors, alloantibody (via IA), autoantibody (via TPE or IA)” with

“coagulation factor inhibitors”

“Hematopoietic stem cell

transplantation, major/minor HPC(A)” with “hematopoietic

stem cell transplantation, major/minor ABO incompatibility with pure

RBD aplasia, minor HPC(A)”

“Hyperleukocytosis,

prophylaxis” with “hyperleukocytosis”

“Hypertriglyceridemic

pancreatitis” with “hypertriglyceridemic pancreatitis, prevention”

“Immunoglobulin

nephropathy” with “IgA nephropathy (Berger’s Disease)”

“Multiple sclerosis (unless noted [in the policy] as proven)” with

“multiple sclerosis, chronic (unless noted [in the policy] as proven)”

“Red cell

alloimmunization, in pregnancy” with “red cell

alloimmunization,

prevention and

Hemophagocytic lymphohistiocytosis

Henoch-Schonlein purpura Heparin induced thrombocytopenia and thrombosis Hyperleukocytosis Hypertriglyceridemic pancreatitis, prevention

Immune thrombocytopenia IgA nephropathy (Berger’s Disease) Inflammatory bowel disease, via Extracorporeal Photopheresis

Lambert-Eaton myasthenic syndrome Liver transplantation

o ABO incompatible

o Antibody mediated rejection Lung transplantation

o Antibody mediated rejection o Desensitization

Malaria Multiple sclerosis, chronic (unless noted above as proven)

Nephrogenic systemic fibrosis

Neuromyelitis optica spectrum disorders, maintenance Overdose, venoms, and poisoning Paraneoplastic neurologic syndromes

Paraproteinemic polyneuropathy (unless noted above as proven) Pediatric autoimmune neuropsychiatric disorders associated with

streptococcal infections (Sydenham’s chorea, severe) Pemphigus vulgaris

Phytanic acid storage disease (Refsum’s disease) Post transfusion purpura Psoriasis

Red cell alloimmunization, prevention and treatment Renal transplantation, ABO compatible, desensitized, deceased donor Scleroderma (systemic sclerosis)

Sepsis with multiorgan failure Sickle cell disease (unless noted above as proven) Stiff-person syndrome Sudden sensorineural hearing loss

Systemic lupus erythematosus, severe Thrombocytosis

Thrombotic microangiopathy (unless noted above as proven)

Thyroid storm




REVISED

Apheresis

(continued)

Nov. 1, 2019 treatment”

“Sickle cell disease, non-acute (unless noted [in the policy] as proven)” with “sickle cell disease

(unless noted [in the policy] as proven)”

Supporting Information

Updated Clinical Evidence and References sections to reflect the most current information

Toxic epidermal necrolysis

Vasculitis (unless noted above as proven) Note: Refer to the Description of Services section for information regarding all apheresis-based procedures.

Bariatric Surgery

Dec. 1, 2019

Coverage Rationale Added language to indicate the

TransPyloric Shuttle (TPS) Device is unproven and not medically necessary for treating

obesity

Supporting Information Updated Description of Services,

Clinical Evidence, FDA, and References sections to reflect the most current information

The following bariatric surgical procedures are proven and medically

necessary for treating obesity: Gastric bypass (includes robotic-assisted gastric bypass)

o Laparoscopic adjustable gastric banding for individuals > 18 years of

age. Refer to the U.S. Food and Drug Administration (FDA) section

for additional information Gastric sleeve procedure

Vertical banded gastroplasty Biliopancreatic bypass Biliopancreatic diversion with duodenal switch

In adults, bariatric surgery using one of the procedures identified above for treating obesity is proven and medically necessary when ALL of the following criteria are met:

Class III obesity; or Class II obesity in the presence of one or more of the following co-

morbidities:

o Type 2 diabetes; or o Cardiovascular disease [e.g., stroke, myocardial infarction, poorly

controlled hypertension (systolic blood pressure greater than 140

mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy)]; or

o History of coronary artery disease with a surgical intervention such as coronary artery bypass or percutaneous transluminal coronary

angioplasty; or

o History of cardiomyopathy; or o Obstructive Sleep Apnea (OSA) confirmed on polysomnography with




REVISED

Bariatric Surgery

(continued)

Dec. 1, 2019

an AHI or RDI of >30

and The individual must also meet the following criteria:

o Both of the following: Completion of a preoperative evaluation that includes a detailed

weight history along with dietary and physical activity patterns; and

Psychosocial-behavioral evaluation to provide screening and

identification of risk factors or potential postoperative challenges that may contribute to a poor postoperative outcome

or

o Participation in a multi-disciplinary surgical preparatory regimen In Adolescents, the bariatric surgical procedures identified above are proven and medically necessary for treating obesity when ALL of the

following criteria are met: Class III obesity; or

Class II obesity in the presence of one or more of the following co-

morbidities: o Type 2 diabetes; or o Cardiovascular disease [e.g., stroke, myocardial infarction, poorly

controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite pharmacotherapy)]; or

o History of coronary artery disease with a surgical intervention such

as coronary artery bypass or percutaneous transluminal coronary angioplasty; or

o History of cardiomyopathy; or

o Obstructive Sleep Apnea confirmed on polysomnography with an AHI or RDI of >30

and

The individual must also receive an evaluation at, or in consultation with, a multidisciplinary center focused on the surgical treatment of severe childhood obesity. This may include adolescent centers that have received accreditation by the Metabolic and Bariatric Surgery

Accreditation and Quality Improvement Program (MBSAQIP) or can demonstrate similar programmatic components.

Revisional Bariatric Surgery using one of the procedures identified




REVISED

Bariatric Surgery

(continued)

Dec. 1, 2019 above is proven and medically necessary when due to a Technical

Failure or Major Complication from the initial bariatric procedure. The following procedures are unproven and not medically necessary for treating obesity due to insufficient evidence of efficacy:

Revisional Bariatric Surgery for any other indication than those listed above

Bariatric surgery as the primary treatment for any condition other than

obesity Bariatric surgical interventions for the treatment of obesity including but

not limited to:

o Transoral endoscopic surgery o Mini-gastric bypass (MGB) or laparoscopic mini-gastric bypass (LMGBP) o Gastric electrical stimulation with an implantable gastric stimulator

(IGS) o VBLOC® vagal blocking therapy

o Intragastric balloon

o Laparoscopic greater curvature plication, also known as total gastric vertical plication o Stomach aspiration therapy (AspireAssist®)

o Bariatric artery embolization (BAE) o Single-Anastomosis Duodenal Switch (also known as duodenal switch

with single anastomosis, or stomach intestinal pylorus sparing surgery [SIPS])

o TransPyloric Shuttle (TPS) Device Gastrointestinal liners (EndoBarrier®) are investigational, unproven

and not medically necessary for treating obesity due to lack of U.S. Food and Drug Administration (FDA) approval, and insufficient evidence of efficacy.

Epidural Steroid and Facet

Injections for Spinal Pain

Dec. 1, 2019

Coverage Rationale Added coverage criteria for

Epidural Steroid Injections (ESI) for treating lumbar radicular pain caused by spinal stenosis, disc

herniation or degenerative changes in the vertebrae

Note: This policy addresses Epidural Steroid Injections (ESI) of the lumbar spine only. The policy does not address Epidural Steroid Injections of the

cervical or thoracic spine, nor does it address injections for obstetrical or surgical anesthetic. The policy addresses Facet Joint Injections of multiple sites and is not limited to Facet Joint Injections of the lumbar spine.

The following are proven and medically necessary:




REVISED

Epidural Steroid

and Facet Injections for Spinal Pain (continued)

Dec. 1, 2019 requiring:

o The pain is associated with symptoms of nerve root irritation and/or low back pain due to disc extrusions

and/or contained herniations; and

o The pain is unresponsive to

Conservative Treatment, including but not limited to pharmacotherapy, exercise

or physical therapy Replaced language indicating

“therapeutic Facet Joint Injection (FJI) is unproven and not

medically necessary for treating chronic spinal pain” with

“therapeutic Facet Joint Injection

(FJI) and/or facet nerve block (i.e., medial branch block) are unproven and not medically

necessary for treating chronic spinal pain”

Definitions Added definition of:

o Facet Joint Injections (FJIs) o Facet Nerve Block o Medial Branch Block

Supporting Information Updated Clinical Evidence and

References sections to reflect the

most current information

Epidural Steroid Injections (ESI) for treating lumbar radicular pain

caused by spinal stenosis, disc herniation, degenerative changes in the vertebrae or for the short-term management of low back pain when the following criteria are met: o The pain is associated with symptoms of nerve root irritation and/or

low back pain due to disc extrusions and/or contained herniations; and

o The pain is unresponsive to Conservative Treatment, including but

not limited to pharmacotherapy, exercise or physical therapy Diagnostic Facet Joint Injection (FJI) and/or facet nerve block (i.e.,

medial branch block) to localize the source of pain to the facet joint in

persons with spinal pain The following are unproven and not medically necessary due to insufficient evidence of efficacy:

The use of ultrasound guidance for ESIs and FJIs ESI for all other indications of the lumbar spine not included above

Therapeutic Facet Joint Injection (FJI) and/or facet nerve block (i.e.,

medial branch block) for treating chronic spinal pain Epidural Steroid Injection Limitations

A maximum of three (3) ESI (regardless of level, location, or side) in a year will be considered medically necessary when criteria (indications for coverage) are met for each injection

A session is defined as one date of service in which ESI injection(s) are performed

A year is defined as the 12-month period starting from the date of

service of the first approved injection




REVISED

Genetic Testing for

Hereditary Cancer

Oct. 1, 2019

Notice of Revision: The following

summary of changes has been modified. Revisions to the previous policy update announcement are outlined in red below. Please take

note of the additional updates implemented on Oct. 1, 2019.

Coverage Rationale Simplified content

Hereditary Breast and Ovarian

Cancer (BRCA1/BRCA2) Revised list of proven and

medically necessary indications for:

o Men with a personal history of prostate cancer

o Women with a personal

history of Breast Cancer o Individuals without a

personal history of a related

cancer

Multi-Gene Hereditary Cancer Panel Testing Criteria Revised coverage

guidelines/criteria for individuals: o With an indication for testing

for hereditary Breast and Ovarian Cancer

o With an indication for testing

for hereditary colorectal cancer

o Without an indication for testing for hereditary Breast

and Ovarian cancer or colorectal cancer

Documentation Requirements

Removed 0104U from the list of

Genetic counseling is strongly recommended prior to these tests in order to

inform persons being tested about the advantages and limitations of the test as applied to a unique person. Hereditary Breast and Ovarian Cancer (BRCA1/BRCA2)

Genetic testing for BRCA1 and BRCA2 for individuals with a personal history of a related cancer is proven and medically necessary in the

following situations: Individuals with a BRCA 1/2 pathogenic mutation detected in tumor

tissue; or

Individuals with a personal history of pancreatic cancer; or Men with a personal history of Breast Cancer; or Men with a personal history of prostate cancer in any of the following

situations:

o At least one Close Blood Relative who has a BRCA1 or BRCA2 mutation; or

o Metastatic prostate cancer; or

o High risk prostate cancer (Gleason Score at least 7) with at least one Close Blood Relative with a BRCA-Related Cancer; or

o At least two Close Blood Relatives with BRCA-Related Cancer; or

o Ashkenazi Jewish ancestry; or o An unknown or Limited Family History

Women with a personal history of Ovarian Cancer; or Women with a personal history of Breast Cancer in any of the following

situations: o Metastatic Breast Cancer; or o Breast Cancer diagnosed at age 45 or younger; or

o An additional Breast Cancer primary (prior diagnosis or bilateral cancer); or

o Triple-Negative Breast Cancer diagnosed at age 60 or younger; or

o At least one Close Blood Relative who has a BRCA1 or BRCA2 mutation; or

o Ashkenazi Jewish ancestry; or o At least one Close Blood Relative with a BRCA-Related Cancer; or

o An unknown or Limited Family History Genetic testing for BRCA1 and BRCA2 for individuals without a

personal history of a related cancer is proven and medically necessary in the following situations:




REVISED

Genetic Testing for

Hereditary Cancer (continued)

Oct. 1, 2019

CPT codes with associated

documentation requirements (quarterly code edit)

Applicable Codes Updated list of applicable CPT

codes for multi-gene panel to reflect quarterly code edits: o Added 0129U, 0130U,

0131U, 0132U, 0133U, 0134U, 0135U, and 0138U

o Removed 0104U

Definitions Added definition of:

o BRCA-Related Cancers o Multi-Gene Panel

o Panel Modified definition of:

o Lynch Syndrome-Associated

Cancer


Clinical Evidence, CMS, and References sections to reflect the most current information

A known BRCA1/BRCA2 mutation in a Close Blood Relative; or

At least two Close Blood Relatives with a BRCA-Related Cancer; or Ashkenazi Jewish ancestry and at least one Close Blood Relative with a

BRCA-Related Cancer

Genetic testing for BRCA1 and/or BRCA2 is unproven and not medically necessary for all other indications including: Screening for cancer risk for individuals not listed in the proven

indications above; or Risk assessment of other cancers; or Confirmation of direct to consumer genetic testing without meeting any

of the proven indications above Multi-Gene Hereditary Cancer Panel Testing Criteria

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals with an indication for testing for hereditary Breast and Ovarian cancer is proven and medically necessary if all of the

following criteria are met: The suspected hereditary cancer syndromes can be diagnosed by testing

of two or more genes included in the specific hereditary cancer Panel;

and The individual meets at least one of the criteria for Hereditary Breast and

Ovarian Cancer (BRCA1/BRCA2) (see above section); and The individual has a family history or personal history that is strongly

suggestive of more than one hereditary cancer syndrome including at least one of the following: o A personal history of at least two different cancers (e.g., Breast and

Ovarian); or o A personal history of cancer diagnosed at age 40 or younger; or o A personal history of cancer and at least one Close Blood Relative

with a cancer associated with Lynch Syndrome; or o At least one Close Blood Relative diagnosed with a BRCA-Related

Cancer at age 40 or younger; or o At least three Close Blood Relatives diagnosed with any cancer

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals with an indication for testing for hereditary colorectal

cancer is proven and medically necessary in the following situations: The suspected hereditary cancer syndromes can be diagnosed by testing




REVISED

Genetic Testing for


Oct. 1, 2019

of two or more genes included in the specific hereditary cancer Panel;

and The individual has a personal or family history with at least one of the

following criteria for Hereditary Colorectal Cancer/Lynch Syndrome-Associated Cancer or colorectal polyposis syndrome:

o A personal history of cancer associated with Lynch Syndrome; or o A personal history of cancer where tumor testing results demonstrate

that the cancer was MSI-high or had immunohistochemical staining

showing the absence of one or more mismatch repair proteins (MLH1, MSH2, MSH6 or PMS2); or

o A personal history of colorectal polyposis with at least 10

adenomatous polyps, at least 2 hamartomatous polyps or at least 5 serrated polyps proximal to the sigmoid colon; or

o At least one 1st degree Blood Relative with a cancer associated with Lynch Syndrome; or

o At least one Close Blood Relative with a cancer associated with Lynch Syndrome diagnosed at age 50 or younger; or

o At least one Close Blood Relative with at least two cancers associated

with Lynch Syndrome; or o Two or more Close Blood Relatives with a cancer associated with

Lynch Syndrome; or

o At least one Close Blood Relative with a clinical diagnosis of Familial Adenomatous Polyposis, Attenuated Familial Adenomatous Polyposis, Juvenile Polyposis Syndrome or Peutz-Jeghers Syndrome; or

o A PREMM5, MMRpro or MMRpredict Score of 2.5% or greater for

having a Lynch syndrome gene mutation Genetic testing with a Multi-Gene hereditary cancer Panel in

individuals without an indication for testing for hereditary Breast and Ovarian cancer or colorectal cancer is proven and medically necessary in the following situations:

The suspected hereditary cancer syndromes can be diagnosed by testing of two or more genes included in the specific hereditary cancer Panel; and

The results of testing will directly impact this individual’s medical

management; and The individual has a family history or personal history that is strongly

suggestive of more than one hereditary cancer syndrome as outlined

below:




REVISED

Genetic Testing for


Oct. 1, 2019

o A personal history of at least two different cancers (e.g., Breast and

colon); or o A personal history of cancer diagnosed at age 40 or younger; or o A personal history of cancer and at least one Close Blood Relative

with a cancer associated with Lynch Syndrome; or

o At least one Close Blood Relative diagnosed with a BRCA-Related Cancer at age 40 or younger; or

o At least three Close Blood Relatives diagnosed with any cancer

Genetic testing with a Multi-Gene hereditary cancer Panel in individuals diagnosed with cancer at age 18 or younger is proven and

medically necessary. Multi-Gene hereditary cancer Panels are unproven and not medically necessary for all other indications.

Omnibus Codes

Dec. 1, 2019

Coverage Rationale

Revised coverage guidelines for:

Sinus tarsi implant (CPT code 0335T and HCPCS code

S2117) o Updated list of applicable

codes; added S2117

Electroretinogram (CPT codes

0509T and 92274) o Added language to indicate

multifocal electroretinogram

(mfERG) is proven and medically necessary for chloroquine (CQ) and

hydroxychloroquine (HCQ) retinopathy screening

o Replaced language indicating “multifocal electroretinogram

(mfERG) is unproven and not medically necessary due to insufficient evidence of

safety and/or efficacy” with “multifocal electroretinogram

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

Omnibus Codes.




REVISED

Omnibus Codes

(continued)

Dec. 1, 2019 (mfERG) is unproven and not

medically necessary for all other indications [not listed as proven and medically necessary] due to

insufficient evidence of safety and/or efficacy”

Instrument-based ocular

photoscreening (CPT codes 99174 and 99177) o Updated language pertaining

to age requirements to indicate instrument-based ocular photoscreening is proven and medically

necessary for one of the following:

As a mass screening

instrument for children 1-5 years of age (ends on 6th birthday)

In individuals 6 years of age and older who are developmentally delayed and are unable or

unwilling to cooperate with routine visual acuity screening

Supporting Information Updated Clinical Evidence and

References sections to reflect the

most current information

Vagus and External

Trigeminal Nerve Stimulation

Dec. 1, 2019

Title Change

Previously titled Vagus Nerve Stimulation

Coverage Rationale

Revised coverage criteria for proven and medically necessary

Implantable vagus nerve stimulators are proven and medically

necessary for treating epilepsy in individuals with ALL of the following (see below for implants that allow detection and stimulation of increased heart rate):

Medically refractory epileptic seizures with failure of two or more trials of single or combination antiepileptic drug therapy or intolerable side effects




REVISED

Vagus and External

Trigeminal Nerve Stimulation (continued)

Dec. 1, 2019

use of implantable vagus nerve

stimulators for treating epilepsy; replaced criterion requiring “the individual is not a surgical candidate or has failed a surgical

intervention” with “the individual is not a candidate for epilepsy surgery or has failed epilepsy

surgery” Revised list of unproven and not

medically necessary indications:

o Added external or transcutaneous (nonimplantable) trigeminal nerve stimulation devices

(e.g., Monarch® eTNS System, Cefaly®) for

preventing or treating all

conditions, including but not limited to: Attention deficit

hyperactivity disorder (ADHD)

Depression Epilepsy

Headache o Updated list of examples of

vagus nerve stimulation

implants that allow detection and stimulation of increased heart rate; added “SenTiva™

Model 1000”


Clinical Evidence, FDA, CMS, and

References sections to reflect the most current information

of antiepileptic drug therapy; and

The individual is not a candidate for epilepsy surgery or has failed epilepsy surgery; and

No history of left or bilateral cervical vagotomy. The U.S. Food and Drug Administration (FDA) identifies a history of left or bilateral cervical

vagotomy as a contraindication to vagus nerve stimulation Implantable vagus nerve stimulators are unproven and not medically necessary for treating ALL other conditions due to insufficient

evidence of efficacy. These conditions include but are not limited to: Alzheimer's disease

Anxiety disorder Autism spectrum disorder Back and neck pain Bipolar disorder

Bulimia Cerebral palsy

Chronic pain syndrome

Cluster headaches Depression Fibromyalgia

Heart failure Migraines Morbid obesity Narcolepsy

Obsessive-compulsive disorder Paralysis agitans Sleep disorders

Tourette's syndrome The following are unproven and not medically necessary due to

insufficient evidence of efficacy: Vagus nerve stimulation implants that allow detection and stimulation of

increased heart rate (e.g., AspireSR™ Model 106, SenTiva™ Model 1000) for treating epilepsy

Transcutaneous (nonimplantable) vagus nerve stimulation (e.g., gammaCore® for headaches) for preventing or treating all indications

External or transcutaneous (nonimplantable) trigeminal nerve stimulation

devices (e.g., Monarch® eTNS System, Cefaly®) for preventing or




REVISED

Vagus and External

Trigeminal Nerve Stimulation (continued)

Dec. 1, 2019 treating all conditions including but not limited to:

o Attention deficit hyperactivity disorder (ADHD) o Depression o Epilepsy o Headache

Note: For vagus nerve blocking for the treatment of obesity, refer to the Medical Policy titled Bariatric Surgery.



Policy Title Effective Date Coverage Rationale

NEW

Cimzia®

(Certolizumab Pegol)

Oct. 1, 2019

TBD

Notice of Implementation Delay: This policy will not be effective on Oct. 1, 2019, as previously announced.

Implementation of the new Medical Benefit Drug Policy has been postponed until further notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin. This policy refers to Cimzia (certolizumab pegol) injection. Cimzia (certolizumab pegol) for self-administered

subcutaneous injection is obtained under the pharmacy benefit. Cimzia is proven and/or medically necessary for the treatment of:

Crohn’s Disease (CD) when all of the following criteria are met: For initial therapy, all of the following:

o Diagnosis of moderately to severely active Crohn’s disease; and o Patient has had an inadequate response to conventional therapies (examples include anti-inflammatory

drugs, corticosteroids, or oral immunosuppressive agents); and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for

self-administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for CD; and

o Patient is not receiving Cimzia in combination with either of the following:

Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

and o Initial authorization will be issued for 12 months.

For continuation of therapy, all of the following: o Documentation of positive clinical response; and

o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self-administration; physician must submit explanation; and

o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for CD; and

o Patient is not receiving Cimzia in combination with either of the following: Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia

(abatacept)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] and

o Authorization will be issued for 12 months.

Rheumatoid Arthritis (RA) when all of the following criteria are met: For initial therapy, all of the following:

o Diagnosis of moderately to severely active rheumatoid arthritis; and

o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for




NEW

Cimzia®

(Certolizumab Pegol) (continued)

Oct. 1, 2019

TBD

self-administration; physician must submit explanation; and

o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for RA; and o Patient is not receiving Cimzia in combination with either of the following:

Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia (abatacept)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] and

o Initial authorization will be issued for 12 months.

For continuation of therapy, all of the following: o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for

self-administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for RA; and o Patient is not receiving Cimzia in combination with either of the following:

Biologic DMARD [e.g., Actemra (tocilizumab), Enbrel (etanercept), Rituxan (rituximab), Orencia

(abatacept)] Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

and

o Authorization will be issued for 12 months. Psoriatic Arthritis (PsA) when all of the following criteria are met:

For initial therapy, all of the following: o Diagnosis of active psoriatic arthritis; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for

self- administration; physician must submit explanation; and

o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PsA; and o Patient is not receiving Cimzia in combination with either of the following:


(abatacept)] Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]



o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self- administration; physician must submit explanation; and

o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PsA; and

o Patient is not receiving Cimzia in combination with either of the following:




NEW

Cimzia®


Oct. 1, 2019

TBD


(abatacept)] Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and


Ankylosing Spondylitis (AS) and non-radiographic Axial Spondyloarthritis (nr-axSpA) when all of the

following criteria are met: For initial therapy, all of the following:

o Diagnosis of active ankylosing spondylitis or non-radiographic axial spondyloarthritis; and

o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for self- administration; physician must submit explanation; and

o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for AS or nr-axSpA; and


(abatacept)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] and

o Initial authorization will be issued for 12 months. For continuation of therapy, all of the following:

o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for

self- administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for AS or nr-

axSpA; and


(abatacept)]



Plaque Psoriasis (PS) when all of the following criteria are met:

For initial therapy, all of the following:

o Diagnosis of moderate to severe plaque psoriasis; and




NEW

Cimzia®


Oct. 1, 2019

TBD

o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for

self- administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PS; and o Patient is not receiving Cimzia in combination with either of the following:


(abatacept)] Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]


For continuation of therapy, all of the following:

o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver are not competent to administer Cimzia FDA labeled for

self- administration; physician must submit explanation; and o Cimzia is initiated and titrated according to US Food and Drug Administration labeled dosing for PS; and


(abatacept)]



Krystexxa®

(Pegloticase)

Oct. 1, 2019

Krystexxa (pegloticase) is proven for the treatment of chronic gout refractory to conventional therapy.

Krystexxa (pegloticase) is medically necessary for the treatment of chronic gout when all of the following criteria are met:

For initial therapy, all of the following:

o One of the following:

History of at least 2 gout flares in the previous 12 months At least 1 gouty tophus Chronic gouty arthropathy and

o History of contraindication, intolerance, or treatment failure after 3 months of therapy (at the maximally medically appropriate dose) with both of the following: Zyloprim (allopurinol)

Uloric (febuxostat) and




NEW

Krystexxa®

(Pegloticase) (continued)

Oct. 1, 2019 o One of the following:

Patient has a confirmed baseline serum uric acid of 6 mg/dL or greater prior to initiating Krystexxa despite conventional therapy; or

Both of the following: - Patient has a baseline serum uric acid less than 6 mg/dL

- Patient has at least 1 gouty tophus and

o Member has undertaken appropriate life style modifications (e.g., limiting of alcohol consumption and diet

modifications, discontinuing or changing medications known to cause gout attacks); and o Patient does not have glucose‐6‐phosphate dehydrogenase (G6PD) deficiency; and

o Prescribed by a rheumatologist; and o Dosing is in accordance with the United States Food and Drug Administration approved labeling; and

o Initial authorization will be for no more than 12 months.

For continuation therapy, all of the following:

o Patient has previously received treatment with Krystexxa; and o Patient has experienced a positive clinical response to Krystexxa (e.g., serum uric acid levels < 6mg/dL,

tophus reduction, etc); and o Patient has not experienced one of the following:

Pre-infusion serum uric acid concentration of > 6 mg/dL accompanied by an infusion reaction Pre-infusion serum uric acid concentration of > 6 mg/dL on two consecutive occasions and

o Member has undertaken appropriate life style modifications (e.g., limiting of alcohol consumption and diet modifications, discontinuing or changing medications known to cause gout attacks); and

o Prescribed by a rheumatologist; and

o Dosing is in accordance with the United States Food and Drug Administration approved labeling; and o Reauthorization will be for no more than 12 months.

Krystexxa (pegloticase) is unproven and not medically necessary for the treatment of asymptomatic

hyperuricemia.


UPDATED

Complement

Inhibitors (Soliris® & Ultomiris™)

Oct. 1, 2019 Applicable Codes

Updated list of applicable HCPCS codes to reflect quarterly code edits: o Replaced J3590 with J1303

o Removed C9052




UPDATED

Evenity™

(Romosozumab-Aqqg)

Oct. 1, 2019

Template Update

Reorganized policy template; relocated Background and FDA sections

Coverage Rationale Removed reference link to the Medical Benefit Drug Policy titled Review at Launch for New to Market Medications

(prior authorization requirements effective Oct. 1, 2019)

Applicable Codes Updated list of applicable HCPCS codes to reflect quarterly code edits; replaced C9399 and J3590 with J3111

Gamifant™ (Emapalumab-

Lzsg)

Oct. 1, 2019 Applicable Codes Updated list of applicable HCPCS codes to reflect quarterly code edits:

o Replaced J3490 and J3590 with J9210 o Removed C9050

Onpattro™ (Patisiran)

Oct. 1, 2019 Applicable Codes Updated list of applicable HCPCS codes to reflect quarterly code edits:

o Replaced J3490 with J0222

o Removed C9036


REVISED

Actemra®

(Tocilizumab)

Injection for Intravenous Infusion

Oct. 1, 2019 TBD

Notice of Implementation Delay: The changes described below will not be effective on Oct. 1, 2019, as previously announced. Implementation of the revised Medical Benefit Drug Policy has been postponed until further

notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin. Template Update


Coverage Rationale Revised coverage criteria:

All Indications o Added criterion for initial therapy and continuation of therapy requiring:

One of the following: - Both of the following:

History of failure, contraindication, or intolerance to Actemra labeled for self-administration Physician attests that, in their clinical opinion, the clinical response would be expected to be

superior with Actemra for intravenous infusion

- Physician attestation that the patient or caregiver are not competent to administer Actemra FDA

labeled for self-administration; physician must submit explanation Authorization is for no more than 12 months




REVISED

Actemra®

(Tocilizumab) Injection for Intravenous Infusion

(continued)

Oct. 1, 2019

TBD

For continuation of therapy: Patient has previously received Actemra injection for intravenous infusion

Rheumatoid Arthritis o Added criterion for initial therapy requiring history of failure, contraindication, or intolerance to two of the

following preferred products (document drug, date, and duration of trial): Cimzia (certolizumab)

Humira (adalimumab) Simponi (golimumab) Olumiant (baricitinib)

Rinvoq (upadacitinib) Xeljanz/Xeljanz XR (tofacitinib)


Updated References section to reflect the most current information

Benlysta® (Belimumab)

Oct. 1, 2019 TBD

Notice of Implementation Delay: The changes described below will not be effective on Oct. 1, 2019, as previously announced. Implementation of the revised Medical Benefit Drug Policy has been postponed until further notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin.

Template Update Reorganized policy template; relocated Background and FDA sections

Coverage Rationale

Replaced language indicating “Benlysta (belimumab) is proven and medically necessary for the treatment of systemic lupus erythematosus when all of the [listed] criteria are met” with “Benlysta (belimumab) is proven and medically necessary for the treatment of active systemic lupus erythematosus when all of the [listed]

criteria are met” Revised criteria for initial therapy:

o Added criterion requiring: One of the following:

- Both of the following: History of failure, contraindication, or intolerance to Benlysta labeled for self-administration Physician attests that, in their clinical opinion, the clinical response would be expected to be

superior with Benlysta for intravenous infusion - Physician attestation that the patient or caregiver is not competent to administer Benlysta FDA

labeled for self-administration; physician must submit explanation

Initial authorization is for no more than 12 months o Replaced criterion requiring:

“Diagnosis of active systemic lupus erythematosus” with “diagnosis of active systemic lupus

erythematosus without severe active lupus nephritis or severe active central nervous system lupus”

“Currently receiving at least one standard of care treatment for active systemic lupus erythematosus”




REVISED

Benlysta®

(Belimumab) (continued)

Oct. 1, 2019

TBD

with “currently receiving at least one standard of care treatment for active systemic lupus

erythematosus that is not a biologic or intravenous cyclophosphamide” Added criteria for continuation of therapy

Clotting Factors, Coagulant Blood Products & Other

Hemostatics

Oct. 1, 2019 Coverage Rationale Revised list of applicable long-

acting Factor VIII (recombinant)

products; added Esperoct® [antihemophilic factor (recombinant), glycopegylated-

exei] Added language to indicate

Esperoct [antihemophilic factor (recombinant), glycopegylated-

exei] is not medically necessary for treatment of hemophilia A for the following:

o Routine prophylactic treatment

o Perioperative management

of surgical bleeding o Treatment of bleeding

episodes


Updated Clinical Evidence, FDA, CMS, and References sections to reflect the most current

information

Refer to the policy for complete details on the coverage guidelines for Clotting Factors, Coagulant Blood Products & Other Hemostatics.

Infliximab (Remicade®, Inflectra™,

Renflexis™)

Oct. 1, 2019

Template Update Reorganized policy template;

relocated Background and FDA

sections

Coverage Rationale Added language to indicate

Inflectra™ (infliximab-dyyb) is a

preferred infliximab product;

coverage will be provided for Inflectra™ (infliximab-dyyb)

This policy refers to the following infliximab products: Remicade® (infliximab) Inflectra™ (infliximab-dyyb)

Renflexis™ (infliximab-abda) Preferred Product

Medical Necessity Plans

Remicade® (infliximab) and Inflectra™ (infliximab-dyyb) are the preferred

infliximab products. Coverage will be provided for Remicade® or Inflectra™ (infliximab-dyyb) contingent on the coverage criteria in the Diagnosis-




REVISED

Infliximab

(Remicade®, Inflectra™, Renflexis™) (continued)

Oct. 1, 2019

contingent on the coverage

criteria in the Diagnosis-Specific Criteria section of the policy

Revised preferred product criteria to indicate treatment

with Renflexis™ (infliximab-abda) or another infliximab biosimilar is medically necessary

for the indications specified in the policy when treatment with Remicade and Inflectra is

contraindicated or has failed

Applicable Codes Added ICD-10 diagnosis codes

H20.10, H20.11, H20.12,

H20.13, H20.821, H20.822, H20.823, H20.829, H30.001,

H30.002, H30.003, H30.009,

H30.011, H30.012, H30.013, H30.019, H30.021, H30.022, H30.023, H30.029, H30.031,

H30.032, H30.033, H30.039, H30.041, H30.042, H30.043, H30.049, H30.101, H30.102, H30.103, H30.109, H30.111,

H30.112, H30.113, H30.119, H30.121, H30.122, H30.123, H30.129, H30.131, H30.132,

H30.133, H30.139, H30.20, H30.21, H30.22, H30.23, H30.811, H30.812, H30.813,

H30.819, H30.891, H30.892, H30.893, H30.899, H30.90, H30.91, H30.92, H30.93, H35.021, H35.022, H35.023,

H35.029, H35.061, H35.062, H35.063, H35.069, H44.111,

H44.112, H44.113, and H44.119

Specific Criteria section.

Coverage for Renflexis™ (infliximab-abda) will be provided contingent on the criteria in this section and the coverage criteria in the Diagnosis-Specific Criteria section. In order to continue coverage, members already on

Renflexis™ (infliximab-abda) will be required to change therapy to Remicade® or Inflectra™ unless they meet the criteria in this section.

Preferred Product Criteria

Treatment with Renflexis™ (infliximab-abda), or other infliximab

biosimilar is medically necessary for the indications specified in this policy when BOTH the following criteria are met: One of the following:

o Both of the following:

History of a trial of at least 14 weeks of Remicade and Inflectra resulting in minimal clinical response to therapy and residual disease activity.

Physician attests that in their clinical opinion, the clinical response would be expected to be superior with Renflexis or other infliximab biosimilar product, than experienced with

Remicade or Inflectra. or

o Both of the following: History of intolerance, contraindication, or adverse event to

Remicade and Inflectra. Physician attests that in their clinical opinion, the same

intolerance, contraindication, or adverse event would not be

expected to occur with Renflexis or other infliximab biosimilar product.

and

Both of the following o Patient has not had a loss of a favorable response after established

maintenance therapy with Remicade or other infliximab biosimilar product.

o Patient has not developed neutralizing antibodies to any infliximab biosimilar product that has led to an attenuation of efficacy of therapy.

Non-Medical Necessity Plans




REVISED

Infliximab


Oct. 1, 2019

Any infliximab product is to be approved contingent on the coverage criteria

in the Diagnosis-Specific Criteria section. Diagnosis-Specific Criteria

“Infliximab” will be used to refer to all infliximab products. Infliximab is proven and medically necessary for the treatment of:

Ankylosing spondylitis when the following criterion is met:

o Diagnosis of ankylosing spondylitis (AS).

Crohn’s disease when ONE of the following criteria is met:

o Diagnosis of fistulizing Crohn’s disease (Crohn’s Disease Activity Index (CDAI) ≥ 220 and ≤ 400); or

o Both of the following: Diagnosis of moderately to severely active Crohn’s disease; and History of failure, contraindication, or intolerance to at least one

conventional therapy (e.g., corticosteroids, 6-mercaptopurine, azathioprine, methotrexate, etc.).

Noninfectious uveitis when BOTH of the following criteria are met: o Diagnosis of refractory noninfectious uveitis that is causing or

threatening vision loss (e.g., noninfectious uveitis associated with Behçet’s or Reiter’s syndromes); and

o History of failure, contraindication, or intolerance to all of the following: Topical corticosteroids; and

Systemic corticosteroids; and Immunosuppressive drugs (e.g., azathioprine, cyclosporine, or

methotrexate).

Plaque psoriasis when BOTH of the following criteria are met:

o Diagnosis of chronic severe plaque psoriasis (i.e., extensive and/or disabling); and

o Patient is a candidate for systemic therapy. Psoriatic arthritis when the following criterion is met:

o Diagnosis of psoriatic arthritis (PsA).

Rheumatoid arthritis when BOTH of the following criteria are met:




REVISED

Infliximab


Oct. 1, 2019

o Diagnosis of moderately to severely active rheumatoid arthritis (RA);

and o One of the following:

Patient is receiving concurrent therapy with methotrexate. History of contraindication or intolerance to methotrexate.

Sarcoidosis when ALL of the following criteria are met:

o Diagnosis of sarcoidosis; and

o History of failure, contraindication, or intolerance to corticosteroids (e.g., prednisone, methylprednisolone); and

o History of failure, contraindication, or intolerance to one

immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine).

Ulcerative colitis when BOTH of the following criteria are met:

o Diagnosis of moderately to severely active ulcerative colitis (UC); and

o History of failure, contraindication, or intolerance to at least one

conventional therapy (e.g., 6-mercaptopurine, aminosalicylate, azathioprine, corticosteroids).

Immune checkpoint inhibitor-related toxicities when BOTH of the following criteria are met: o Patient has recently received checkpoint inhibitor therapy [e.g.,

Keytruda (Pembrolizumab), Opdivo (Nivolumab)];and

o One of the following: Both of the following:

- Diagnosis of moderate (G2) or severe (G3-4)

immunotherapy-related diarrhea or colitis; and - History of failure, contraindication, or intolerance to

corticosteroids (e.g. methylprednisolone).

or Both of the following:

- Diagnosis of severe (G3-4) immunotherapy-related pneumonitis; and

- History of failure, contraindication, or intolerance to corticosteroids (e.g. methylprednisolone).

or

Both of the following:




REVISED

Infliximab


Oct. 1, 2019

- Diagnosis of severe (G3) or life-threatening (G4)

immunotherapy-related acute renal failure/elevated serum creatinine; and

- Toxicity remains >G2 after 1 week of corticosteroids. or

Both of the following: - Diagnosis of severe (G3-4) immunotherapy-related uveitis;

and

- Toxicity remains after 1 week of high dose systemic corticosteroids.

or

Both of the following: - Diagnosis of life threatening (G4) immunotherapy-related

myocarditis, pericarditis, arrhythmias, or impaired ventricular function; and

- No improvement of toxicity within 24 hours of starting pulse-dose methylprednisolone.

or

Both of the following: - Diagnosis of severe immunotherapy-related inflammatory

arthritis; and

- No symptom improvement within 2 weeks of starting high-dose corticosteroids.

There may be other conditions that qualify as serious, rare diseases for

which the use of infliximab may be appropriate. Refer to the Benefit Considerations section of the policy for additional information.

Infliximab is unproven and not medically necessary for the treatment of: Still’s disease

Sjögren’s syndrome Graft-vs-host disease Myelodysplastic syndromes Undifferentiated spondyloarthropathy

Reiter’s syndrome Hidradenitis suppurativa

Wegener’s granulomatosis

Juvenile idiopathic arthritis (juvenile rheumatoid arthritis)




REVISED

Infliximab


Oct. 1, 2019 Infliximab is unproven for the treatment of the above conditions because

statistically robust randomized controlled trials are needed to address the issue of whether infliximab has sufficient superiority in clinical efficacy compared to other available treatments to justify the inherent clinical risk in the use of a monoclonal antibody anti-tumor necrosis factor agent.

Ketalar®

(Ketamine) and Spravato™ (Esketamine)

Oct. 1, 2019

Coverage Rationale

Revised medical necessity criteria for the treatment of treatment-resistant depression

(TRD) with Spravato; replaced initial therapy criterion requiring “Spravato will be used in combination with a newly

initiated daily oral antidepressant that has not previously been tried” with

“Spravato will be initiated at the same time the member starts a new daily oral antidepressant

(one that has not previously been tried)”

This policy refers to the following ketamine products:

Ketalar (ketamine) Spravato (esketamine)

Spravato (Esketamine) Nasal Spray

Spravato is proven for the treatment of treatment-resistant

depression (TRD) when ALL of the following criteria are met:

Initial Therapy

Diagnosis for major depressive disorder (treatment-resistant) according to the current DSM (i.e., DSM-5), by a mental health professional; and

Patient has not experienced a clinically meaningful improvement after treatment with at least two different antidepressants of adequate dose, duration (at least 6 weeks), and adherence in the current depressive

episode (must document medications, doses, and durations); and Patient is to receive Spravato therapy in conjunction with another oral

antidepressant; and Provider and/or the provider’s healthcare setting is certified in the

Spravato REMS program; and Spravato dosing is in accordance with the United States Food and Drug

Administration approved labeling; and

Initial authorization will be for no longer than 12 weeks.

Continuation of Therapy

Patient has previously been treated with Spravato; and

Documentation demonstrating a positive clinical response from baseline (e.g., improved Montgomery-Asberg Depression Rating Scale [MADRS], clinical remission, response, etc.), as defined by the provider; and

Patient is to receive Spravato therapy in conjunction with another oral


Spravato REMS program; and

Spravato dosing is in accordance with the United States Food and Drug




REVISED

Ketalar®

(Ketamine) and Spravato™ (Esketamine) (continued)

Oct. 1, 2019

Administration approved labeling; and

Authorization will be for no longer than 6 months.

Spravato is medically necessary for the treatment of treatment-resistant depression (TRD) when ALL of the following criteria are met:

Initial Therapy

Diagnosis of major depressive disorder (treatment-resistant), according to the current DSM (i.e., DSM-5), by a mental health professional; and

Prescribed by or in consultation with a psychiatrist; and Attestation of baseline scoring (prior to starting Spravato) on at least

one of the following clinical assessments has been completed:

o Baseline score on the 17-item Hamilton Rating Scale for Depression (HAMD17)

o Baseline score on the 16-item Quick Inventory of Depressive Symptomatology (QIDS-C16)

o Baseline score on the 10-item Montgomery-Asberg Depression Rating

Scale (MADRS) and

Patient has not experienced a clinically meaningful improvement after treatment with at least three different antidepressants or treatment regimens of adequate dose (maximally tolerated), duration (at least 8

weeks), and adherence in the current depressive episode o An antidepressant or treatment regimen would include any of the

following classes or combinations (document medication, dose, and duration):

Selective serotonin reuptake inhibitors (e.g., citalopram, fluoxetine, paroxetine, sertraline)

Serotonin norepinephrine reuptake inhibitors (e.g., duloxetine,

venlafaxine, etc.) Bupropion Tricyclic antidepressants (e.g., amitriptyline, clomipramine,

nortriptyline, etc.) Mirtazapine Monoamine oxidase inhibitors (e.g., selegiline, tranylcypromine,

etc.)

Serotonin modulators (e.g., nefazodone, trazodone, etc.)

Augmentation with lithium, Cytomel (liothyronine), antipsychotics, or anticonvulsants




REVISED

Ketalar®


Oct. 1, 2019

and

Spravato will be initiated at the same time the member starts a new daily oral antidepressant (one that has not previously been tried); and

Provider and/or the provider’s healthcare setting is certified in the Spravato REMS program; and

Spravato dosing is in accordance with the United States Food and Drug Administration (FDA) approved labeling; and

Initial authorization will be for no longer than 12 weeks.

Continuation of Therapy

Patient has previously been treated with Spravato; and Documentation of remission or a positive clinical response to Spravato;

and Submission of baseline and recent (within the last month) scoring on at

least one of the following assessments demonstrating remission or clinical response (e.g., score reduction from baseline) as defined by the:

o Hamilton Rating Scale for Depression (HAMD17; remission defined as

a score of ≤7) o Quick Inventory of Depressive Symptomatology (QIDS-C16;

remission defined as a score of ≤5) o Montgomery-Asberg Depression Rating Scale (MADRS; remission

defined as a score of ≤12)

and Patient is to receive Spravato therapy in conjunction with an oral


Spravato REMS program; and Prescribed by or in consultation with a psychiatrist; and Spravato dosing is in accordance with the United States FDA approved

labeling; and Authorization will be for no longer than 6 months.

Spravato is unproven and not medically necessary for the following: Anesthetic agent Chronic pain (including but not limited to nonmalignant pain,

Fibromyalgia, neuropathic pain, Complex Regional Pain Syndrome, Reflex

Sympathetic Dystrophy)

Migraine headaches




REVISED

Ketalar®


Oct. 1, 2019 Ketalar (Ketamine) Injection

Ketamine injection is considered medically necessary and may be covered for the following: Anesthesia for diagnostic and surgical procedures that do not require

skeletal muscle relaxation The induction of anesthesia prior to administration of other anesthesia

agents

As supplemental anesthesia for low-potency agents, such as nitrous oxide

Ketamine injection is investigational, and therefore not proven or medically necessary for the following: Psychiatric disorders (including, but not limited to depression, bipolar

disorder, & posttraumatic stress disorder)

Chronic pain (including but not limited to nonmalignant pain, Fibromyalgia, neuropathic pain, Complex Regional Pain Syndrome, Reflex Sympathetic Dystrophy)

Migraine headaches

Maximum Dosage

Oct. 1, 2019

Related Policies Added reference link to the

Medical Benefit Drug Policy

titled: o Cimzia® (Certolizumab Pegol) o Onpattro™ (Patisiran)

Coverage Rationale

Added language to clarify the use of medications included in this policy, when given within

the maximum dosage based upon body surface area or patient weight or a set of

maximal dosage independent of patient body size, are proven when used according to labeled indications or when otherwise

supported by published clinical

evidence Revised list of applicable drug

This policy provides information about the maximum dosage per administration for certain medications administered by a medical professional. Most medications have a maximum dosage based upon body

surface area or patient weight or a set maximal dosage independent of patient body size. Drug Products:

bevacizumab (Avastin®) bevacizumab-awwb (Mvasi™) bevacizumab-bvzr (Zirabev™)

certolizumab pegol (Cimzia®) denosumab (Prolia® & Xgeva®) eculizumab (Soliris®)

infliximab (Remicade®) infliximab-dyyb (Inflectra™) infliximab-abda (Renflexis™) nivolumab (Opdivo®)

omalizumab (Xolair®)

patisiran (Onpattro™) pegfilgrastim (Neulasta®)




REVISED

Maximum Dosage

(continued)

Oct. 1, 2019

products; added:

o bevacizumab-awwb (Mvasi™)

o bevacizumab-bvzr (Zirabev™)

o certolizumab pegol (Cimzia®) o patisiran (Onpattro™) o ravulizumab-cwvz

(Ultomiris™) o rituximab-abbs (Truxima®) o trastuzumab-anns

(Kanjinti™) o trastuzumab-dkst (Ogivri™) o trastuzumab-dttb

(Ontruzant™)

o trastuzumab-pkrb (Herzuma®)

o trastuzumab-qyyp

(Trazimera™) Revised Maximum Allowed

Quantities by HCPCS Units and

Maximum Allowed Quantities for National Drug Code (NDC) Billing

Applicable Codes Added HCPCS codes J0222,

J0717, J1303, Q5107, Q5112, Q5113, Q5114, Q5115, Q5116, Q5117, and Q5118

Updated National Drug Codes (NDCs): o Added 00006-5033-02,

00069-0305-01, 00069-0315-01, 00069-0342-01, 25682-0022-01, 50242-0214-01, 50242-0215-01,

50474-0700-62, 50474-0710-79, 50474-0710-81,

55513-0132-01, 55513-

0206-01, 55513-0207-01,

pegfilgrastim-cbqv (Udenyca™)

pegfilgrastim-jmdb (Fulphila™) ravulizumab-cwvz (Ultomiris™) rituximab (Rituxan®) rituximab-abbs (Truxima®)

trastuzumab (Herceptin®) trastuzumab-anns (Kanjinti™) trastuzumab-dkst (Ogivri™)

trastuzumab-dttb (Ontruzant™) trastuzumab-pkrb (Herzuma®) trastuzumab-qyyp (Trazimera™)

ustekinumab (Stelara®) vedolizumab (Entyvio®) zoledronic acid (zoledronic acid, Reclast® and Zometa®)

The use of medications included in this policy when given within the maximum dosage based upon body surface area or patient weight or

a set of maximal dosage independent of patient body size are proven

when used according to labeled indications or when otherwise supported by published clinical evidence.

The medications included in this policy when given beyond maximum dosages based upon body surface area or patient weight or a set maximal dosage independent of patient body size are not supported by package labeling or published clinical evidence and are unproven.

This policy creates an upper dose limit based on the clinical evidence and the 95th percentile for adult body weight (128 kg) and body surface area (2.59

meters2) in the U.S. (adult male, 30 to 39 years, Fryar, 2016). In some cases, the maximum allowed units and/or vials may exceed the upper level limit as defined within this policy due to an individual patient body weight >

128 kg or body surface area > 2.59 meters2. Maximum Allowed Quantities by HCPCS Units

Refer to the policy for complete details on the Maximum Allowed Quantities by HCPCS Units for the drug products listed above.

Maximum Allowed Quantities for National Drug Code (NDC) Billing

Refer to the policy for complete details on the Maximum Allowed




REVISED

Maximum Dosage

(continued)

Oct. 1, 2019 63459-0103-10, 63459-

0104-50, 63459-0303-43, 63459-0305-47, 67457-0847-44, 67457-0991-15, and 71336-1000-01

o Removed 50242-0056-56 and 50242-0134-68


Updated CMS and References sections to reflect the most current information

Quantities for NDC Billing for the drug products listed above.

Oncology Medication Clinical

Coverage

Oct. 1, 2019

Related Policies Added reference link to the

Medical Policy titled Therapeutic Radiopharmaceuticals

Coverage Rationale

Removed language pertaining to “select ancillary and supportive care medications for oncology

conditions” Added language to indicate:

o Coverage of White Blood Cell Colony Stimulating Factors is

addressed in a separate policy


o The Oncology Products table lists the UnitedHealthcare preferred oncology products

and respective non-preferred products; coverage will be provided for the UnitedHealthcare preferred

oncology product contingent on the coverage criteria in the Diagnosis-Specific

Criteria section of the policy o Coverage for any respective

Description

This policy provides parameters for coverage of injectable oncology medications (J9000-J9999) [including, but not limited to octreotide acetate (J2353 and J2354), leuprolide acetate (J1950), leucovorin (J0640) and

levoleucovorin (J0641)] 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 Administration (FDA)-approved disease indications and specific NCCN panel recommendations. Each recommendation is supported by a level of evidence

category. Coverage of White Blood Cell Colony Stimulating Factors is addressed in a separate policy. This policy does not provide coverage criteria for Chimeric Antigen Receptor (CAR)-T Cell products. Coverage determinations are based on the member’s benefits and the OptumHealth

Transplant Solutions criteria for covered transplants; refer to the Clinical Guideline titled Transplant Review Guidelines: Hematopoietic Stem Cell Transplantation.

Coverage Rationale


The Oncology Products table below lists the UnitedHealthcare preferred oncology products and respective non-preferred products. Coverage will be

provided for the UnitedHealthcare preferred oncology product contingent on the coverage criteria in the Diagnosis-Specific Criteria section.

Coverage for any respective non-preferred oncology product will be provided




REVISED

Oncology

Medication Clinical Coverage (continued)

Oct. 1, 2019

non-preferred oncology

product will be provided contingent on the criteria in the Medical Necessity Criteria and the Diagnosis-

Specific Criteria sections of the policy; members new to therapy will be required to

utilize the UnitedHealthcare preferred oncology product unless they meet the

[following] criteria: Treatment with the

respective non-preferred product specified in the

Oncology Products table is medically necessary

for oncology indications

when both of the following are met: - History of intolerance

or contraindication to the UnitedHealthcare preferred oncology product; and

- Physician attests that, in their clinical opinion, the same

intolerance, contra-indication, or adverse event would not be

expected to occur with the respective non-preferred product

o The Oncology Products table

lists the UnitedHealthcare preferred oncology products

with therapeutically

equivalent and/or biosimilar

contingent on the criteria in the Medical Necessity Criteria and the Diagnosis-

Specific Criteria sections. Members new to therapy will be required to utilize the UnitedHealthcare preferred oncology product unless they meet the criteria in this section.

Medical Necessity Criteria

Treatment with the respective non-preferred product specified in the

Oncology Products table is medically necessary for oncology indications when BOTH of the following are met: History of intolerance or contraindication to the UnitedHealthcare

preferred oncology product; and Physician attests that, in their clinical opinion, the same intolerance,

contraindication, or adverse event would not be expected to occur with the respective non-preferred product.

Oncology Products

Below are UnitedHealthcare preferred oncology products with therapeutically

equivalent and/or biosimilar* non-preferred products as determined by the United Helathcare P&T Committee:

UnitedHealthcare Preferred

Oncology Product Non-Preferred Product

Mvasi (bevacizumab-awwb) Avastin (bevacizumab)

Zirabev (bevacizumab-bvzr)

Kanjinti (trastuzumab-anns)

Herceptin (trastuzumab)

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk)

Herzuma (trastuzumab-pkrb)

Ogivri (trastuzumab-dkst)

Ontruzant (trastuzumab-dttb)

Trazimera (trastuzumab-qyyp)

Leucovorin Levoleucovorin

*Biosimilar means that the biological product is FDA-approved based on data demonstrating that it is highly similar to an already FDA-approved biological

product, known as a reference product, and that there are no clinically

meaningful differences between the biosimilar product and the reference product.




REVISED

Oncology


Oct. 1, 2019

non-preferred products as

determined by the UnitedHealthcare Pharmacy and Therapeutics (P&T) Committee; biosimilar

means that the biological product is FDA-approved based on data demonstrating

that it is highly similar to an already FDA-approved biological product, known as

a reference product, and that there are no clinically meaningful differences between the biosimilar

product and the reference product

Diagnosis-Specific Criteria

o Refer to the Medical Necessity Criteria section of the policy for the UnitedHealthcare

preferred oncology products that have therapeutically equivalent and/or biosimilar products available

Additional Information o Modified language to indicate

the NCCN Clinical Practice

Guidelines in Oncology (NCCN Guidelines®) are comprehensive guidelines

documenting management decisions and interventions and interventions that apply to malignancies which apply

to more than 97% of cancers affecting U.S. patients


Updated References section to


Injectable Oncology Medications

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. 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.

Refer to the Medical Necessity Criteria for the UnitedHealthcare preferred oncology products that have therapeutically equivalent and/or biosimilar products available.

Additional Information

The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) are comprehensive guidelines documenting management decisions and interventions and interventions that apply to malignancies which apply to

more than 97% of cancers affecting U.S. patients. NCCN Categories of Evidence and Consensus

Category 1: The recommendation is based on high-level evidence (i.e., high-powered randomized clinical trials or meta-analyses), and the panel has reached uniform consensus that the recommendation is indicated. In

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

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

but despite the absence of higher level studies, there is uniform consensus that the recommendation is appropriate. Lower level evidence is interpreted broadly, and runs the gamut from phase II to large cohort studies to case series to individual practitioner experience. Importantly,

in many instances, the retrospective studies are derived from clinical experience of treating large numbers of patients at a member institution,

so panel members have first-hand knowledge of the data. Inevitably,

some recommendations must address clinical situations for which limited




REVISED

Oncology


Oct. 1, 2019 reflect the most current

information

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 exists 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.

Orencia® (Abatacept)


Oct. 1, 2019 TBD


notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin. Template Update


Coverage Rationale Added language to indicate Orencia (abatacept) for self-administered subcutaneous injection is obtained under

the pharmacy benefit

Replaced language indicating “Orencia is proven and medically necessary for the treatment of [the listed indications]” with “Orencia is proven and/or medically necessary for the treatment of [the listed indications]

Revised coverage criteria:

All Indications o Added criterion for initial therapy and continuation of therapy requiring:




REVISED

Orencia®

(Abatacept) Injection for Intravenous Infusion

(continued)

Oct. 1, 2019

TBD

One of the following:

- Both of the following: History of failure, contraindication, or intolerance to Orencia labeled for self-administration Physician attests that, in their clinical opinion, the clinical response would be expected to be

superior with Orencia for intravenous infusion

- Physician attestation that the patient or caregiver is not competent to administer Orencia FDA labeled for self-administration; physician must submit explanation

Authorization is for no more than 12 months

For continuation of therapy: Patient has previously received Orencia injection for intravenous infusion

Rheumatoid Arthritis o Added criterion for initial therapy requiring history of failure, contraindication, or intolerance to two of the

following preferred products (document drug, date, and duration of trial): Cimzia (certolizumab) Humira (adalimumab) Simponi (golimumab)

Olumiant (baricitinib) Rinvoq (upadacitinib)

Xeljanz/Xeljanz XR (tofacitinib)

Psoriatic Arthritis o Added criterion for initial therapy requiring history of failure, contraindication, or intolerance to two of the

following preferred products (document drug, date, and duration of trial):

Cimzia (certolizumab) Humira (adalimumab) Simponi (golimumab) Stelara (ustekinumab)

Review at Launch Medication List

Oct. 1, 2019 Removed Cutaquig® [Immune Globulin Subcutaneous (Human) – hipp], Evenity™ (romosozumab-

aqqg), and Zolgensma® (ona-semnogene abeparvovec-xioi); prior authorization requirements effective Oct. 1, 2019

Refer to the Review at Launch Medication List for complete details. Refer to the Medical Benefit Drug Policy titled Review at Launch for New to

Market Medications for additional information.




REVISED

Self-Administered

Medications List

Oct. 1, 2019

Applicable Codes

Added Fasenra (benralizumab) autoinjector, prefilled syringe labeled for self-administration (HCPCS code J0517)

Removed Hemlibra (emicizumab)

Updated list of applicable HCPCS

codes for:

Ajovy (fremanezumab-vfrm) o Replaced J3590 with J3031*

o Removed C9040*

Cimzia (certolizumab pegol) Revised description for J0717

Takhzyro (lanadelumab-flyo)

o Replaced J3590 with J0593* (*quarterly code edit)

Refer to the Self-Administered Medications List for complete details.

Refer to the Medical Benefit Drug Policy titled Self-Administered Medications for additional information.

Simponi Aria®

(Golimumab)


Oct. 1, 2019 TBD


notice; complete details will be provided in a future edition of the Medical Policy Update Bulletin. Template Update Reorganized policy template; relocated Background and FDA sections

Coverage Rationale Revised coverage criteria for initial therapy and continuation of therapy for all indications; added criterion

requiring:

o One of the following: Both of the following:

- History of failure, contraindication, or intolerance to Simponi labeled for self-administration

- Physician attests that, in their clinical opinion, the clinical response would be expected to be superior with Simponi Aria for intravenous infusion

Physician attestation that the patient or caregiver are not competent to administer Simponi FDA labeled for self-administration; physician must submit explanation

o Authorization is for no more than 12 months o For continuation of therapy: Patient has previously received Simponi Aria injection for intravenous infusion




REVISED

Sodium

Hyaluronate

Oct. 1, 2019

Notice of Revision: The following

summary of changes has been modified. Revisions to the previous policy update announcement are outlined in red below. Please take

note of the additional updates implemented on Oct. 1, 2019.

Template Update Changed policy type

classification from “Medical

Policy” to “Medical Benefit Drug Policy”

Added Documentation

Requirements section

Coverage Rationale Added language to indicate:


o Coverage for Durolane, Euflexxa, and Gelsyn-3 is contingent on criteria in the

Diagnosis-Specific Criteria section of the policy; prior authorization is not required

o Coverage for GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc, Synvisc

or Synvisc-One, Gel-One, Monovisc, Triluron, TriVisc, or Synojoynt is contingent on the Medical Necessity

Criteria and Diagnosis-Specific Criteria sections of the policy

In order to continue coverage, members already on these

products will be required to change therapy to


Coverage for Durolane, Euflexxa, and Gelsyn-3 is contingent on criteria in the Diagnosis-Specific Criteria section. Prior authorization is not required.

Coverage for GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc, Synvisc or Synvisc-One, Gel-One, Monovisc, Triluron,

TriVisc, or Synojoynt is contingent on the Medical Necessity Criteria and Diagnosis-Specific Criteria. In order to continue coverage, members already on these products will be required to change therapy to Durolane,

Euflexxa, or Gelsyn-3 unless they meet the criteria below.

Medical Necessity Criteria

Treatment with GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc, Synvisc or Synvisc-One, Gel-One, Monovisc, Triluron, TriVisc, or Synojoynt is

medically necessary for the indications specified in this policy when one the criteria below are met:

Both of the following:

o History of a trial of adequate dose and duration of Durolane, Euflexxa, and Gelsyn-3, resulting in minimal clinical response; and

o Physician attests that, in their clinical opinion, the clinical response

would be expected to be superior than experienced with Durolane, Euflexxa, and Gelsyn-3.

or Both of the following:

o History of failure, contraindication, or intolerance to Durolane, Euflexxa, and Gelsyn-3; and

o Physician attests that, in their clinical opinion, the same failure,

contraindication, or intolerance would not be expected to occur with GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc, Synvisc or Synvisc-One, Gel-One, Monovisc, Triluron, TriVisc, or Synojoynt.

Non-Medical Necessity Plans

Any sodium hyaluronate product is to be approved contingent on the

coverage criteria in the Diagnosis-Specific Criteria section.


Initial Authorization (sodium hyaluronate naïve patients)




REVISED

Sodium

Hyaluronate (continued)

Oct. 1, 2019

Durolane, Euflexxa, or

Gelsyn-3 unless they meet the Medical Necessity Criteria listed in the policy

o Treatment with GenVisc 850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc, Synvisc

or Synvisc-One, Gel-One, Monovisc, Triluron, TriVisc, or Synojoynt is medically

necessary for the indications specified in this policy when one of the criteria below are met:

Both of the following: - History of a trial of

adequate dose and

duration of Durolane, Euflexxa, and Gelsyn-3, resulting

in minimal clinical response

- Physician attests that, in their clinical

opinion, the clinical response would be expected to be

superior than experienced with Durolane, Euflexxa,

and Gelsyn-3 or

Both of the following: - History of failure,

contraindication, or intolerance to

Durolane, Euflexxa,

and Gelsyn-3

Intra-articular injections of sodium hyaluronate are proven and

medically necessary when all of the following are met: Diagnosis of one of the following:

o Hip osteoarthritis o Knee osteoarthritis

o Temporomandibular joint osteoarthritis o Temporomandibular joint disc displacement and

The member has not responded adequately to conservative therapy which may include physical therapy or pharmacotherapy (e.g., non-steroidal anti-inflammatory drugs [NSAIDs], acetaminophen and/or

topical capsaicin cream) or injection of intra-articular steroids and such therapy has not resulted in functional improvement after at least 3 months, or the member is unable to tolerate conservative therapy because of adverse side effects; and

The member reports pain which interferes with functional activities (e.g., ambulation, prolonged standing); and

The pain cannot be attributed to other forms of osteoarthritis; and

There are no contraindications to the injections (e.g., active joint infection, bleeding disorder); and

Dosing is in accordance with the US FDA approved labeling as shown in

the table below; and Initial authorization is for a single injection course once per joint for 6

months.

Reauthorization/Continuation

Repeated courses of intra-articular hyaluronan injections may be considered when ALL of the following are met: Documentation of positive clinical response to therapy (e.g., significant

pain relief was achieved with the prior course of injections); and Pain has recurred; and At least 6 months have passed since the prior course of treatment for the

respective joint; and Dosing is in accordance with the US FDA approved labeling as shown in

the table below; and Continuing authorization is for a single injection course once per joint for

6 months.

The table below shows the FDA approved sodium hyaluronate products and




REVISED

Sodium

Hyaluronate (continued)

Oct. 1, 2019

- Physician attests

that, in their clinical opinion, the same failure, contraindication, or

intolerance would not be expected to occur with GenVisc

850, Hyalgan, Supartz, Visco-3, Hymovis, Orthovisc,

Synvisc or Synvisc-One, Gel-One, Monovisc, Triluron, TriVisc, or Synojoynt

Non-Medical Necessity Plans o Any sodium hyaluronate

product is to be approved

contingent on the coverage criteria in the Diagnosis-Specific Criteria section of

the policy Revised Diagnosis-Specific

Criteria

Applicable Codes

Updated list of applicable HCPCS codes to reflect quarterly code edits; added J7331 and J7332

Added ICD-10 diagnosis codes M16.0, M16.10, M16.11, M16.12, M16.2, M16.30,

M16.31, M16.32, M16.4, M16.50, M16.51, M16.52, M16.6, M16.7, and M16.9


Updated FDA and References sections to reflect the most

current information

their respective FDA labeled dosage per treatment course per joint:

Sodium Hyaluronate Product Course of Treatment per Joint

Durolane 1 injection

Euflexxa 3 injections

Gel One 1 injection

Sodium Hyaluronate Product Course of Treatment per Joint

Gelsyn-3 3 injections

GenVisc 850 3 to 5 injections

Hyalgan 5 injections

Hymovis 2 injections

Monovisc 1 injection

Orthovisc 3 to 4 injections

Supartz 3 to 5 injections

Synvisc 3 injections

Synvisc One 1 injection

TriVisc 3 injections

Visco-3 3 injections

Synojoynt 3 injections

Intra-articular injections of sodium hyaluronate are unproven and not medically necessary for treating any other indication due to insufficient evidence of efficacy.

Hyaluronic acid gel preparations to improve the skin's appearance, contour and/or reduce depressions due to acne, scars, injury or

wrinkles are considered cosmetic and are not covered.




REVISED

Stelara®

(Ustekinumab)

Oct. 1, 2019

Template Update


Coverage Rationale

Added language to indicate Stelara (ustekinumab) for self-administered subcutaneous

injection is obtained under the pharmacy benefit

Replaced language indicating

“Stelara is proven and medically necessary for the treatment of [the listed indications]” with “Stelara is proven and/or

medically necessary for the treatment of [the listed

indications]

Revised coverage criteria for:

Crohn’s Disease o Replaced criterion for initial

therapy requiring: “History of failure,

contraindication, or intolerance to at least

one tumor necrosis factor (TNF) blocker” with “history of

inadequate response or failure, contraindication, or intolerance to at least

one tumor necrosis factor (TNF) blocker”

“History of failure, contraindication, or

intolerance to at least one immunomodulator

or corticosteroid” with

“history of inadequate

This policy refers to Stelara (ustekinumab) injection. Stelara

(ustekinumab) for self-administered subcutaneous injection is obtained under the pharmacy benefit. Stelara is proven and/or medically necessary for the treatment of:

Crohn’s disease when ALL of the following criteria are met: Diagnosis of moderately to severely active Crohn’s disease; and

One of the following: o History of inadequate response or failure, contraindication, or

intolerance to at least one tumor necrosis factor (TNF) blocker [e.g.,

infliximab, Humira (adalimumab), Cimzia (certolizumab)]; or o Both of the following:

History of inadequate response or failure, contraindication, or intolerance to at least one immunomodulator or corticosteroid

(e.g., corticosteroids, 6-mercaptopurine, azathioprine, methotrexate, etc.); and

Patient has never failed a TNF blocker [e.g., infliximab, Humira

(adalimumab), Cimzia (certolizumab)] and

o One of the following:

Initial Therapy - Stelara is to be administered as an intravenous induction

dose; and - Stelara induction dosing is in accordance with the United

States Food and Drug Administration approved labeled dosing for Crohn’s disease: 260mg for patients weighing ≤55kg

390mg for patients weighing >55kg to ≤85kg 520mg for patients weighing >85kg and

- Patient is not receiving Stelara in combination with any of the following: Biologic DMARD [e.g., infliximab, Humira (adalimumab),

Cimzia (certolizumab), Simponi (golimumab)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla

(apremilast)]

and




REVISED

Stelara®

(Ustekinumab) (continued)

Oct. 1, 2019

response or failure,

contraindication, or intolerance to at least one immunomodulator or corticosteroid”

o Updated criteria for continuation of therapy: Added criterion

requiring: - Physician attestation

that the patient or

caregiver are not competent to administer Stelara FDA labeled for self-

administration; physician must

submit explanation

- Authorization is for no more than 12 months

Removed criterion requiring patient is unable to self-administer subcutaneous doses

Plaque Psoriasis o Updated criteria for initial

therapy:

Added criterion requiring: - Physician attestation

that the patient or caregiver are not competent to administer Stelara

FDA labeled for self-administration;

physician must

submit explanation

- Authorization will be for one induction dose.

Continuation of Therapy - Physician attestation that the patient or caregiver is not

competent to administer Stelara FDA labeled for self-administration; physician must submit explanation; and

- Stelara is to be subcutaneously administered 8 weeks after the initial intravenous dose; and

- Stelara continuation dosing is in accordance with the United

States Food and Drug Administration approved labeled dosing for Crohn’s disease: 90mg every 8 weeks subcutaneously; and

- Patient is not receiving Stelara in combination with any of the following: Biologic DMARD [e.g., infliximab, Humira (adalimumab),

Cimzia (certolizumab), Simponi (golimumab)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla

(apremilast)]

- Authorization is for no more than 12 months.

Plaque psoriasis when ALL of the following criteria are met:

For initial therapy, all of the following: o Diagnosis of moderate to severe plaque psoriasis; and o Patient is a candidate for systemic therapy; and o Physician attestation that the patient or caregiver is not competent to

administer Stelara FDA labeled for self-administration; physician must submit explanation; and

o Stelara is initiated and titrated according to US Food and Drug

Administration labeled dosing for plaque psoriasis up to a maximum of (or equivalent dose and interval schedule): 45mg every 12 weeks for patients weighing ≤100kg

subcutaneously 90mg every 12 weeks for patients weighing >100kg

subcutaneously and

o Patient is not receiving Stelara in combination with any of the following:

Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]




REVISED

Stelara®


Oct. 1, 2019

- Initial authorization

is for no more than 12 months

Removed criterion requiring patient is

unable to self-administer subcutaneous doses

o Added criteria for

continuation of therapy

Psoriatic Arthritis o Updated criteria for initial

therapy: Added criterion

requiring: - Physician attestation

that the patient or caregiver are not

competent to

administer Stelara FDA labeled for self-administration;

physician must submit explanation

- Initial authorization is for no more than

12 months Removed criterion

requiring patient is

unable to self-administer subcutaneous doses

o Added criteria for

continuation of therapy


Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] o Initial authorization is for no more than 12 months.


o Physician attestation that the patient or caregiver is not competent to administer Stelara FDA labeled for self-administration; physician must submit explanation; and

o Stelara is initiated and titrated according to US Food and Drug Administration labeled dosing for plaque psoriasis up to a maximum of (or equivalent dose and interval schedule):

45mg every 12 weeks for patients weighing ≤100kg subcutaneously

90mg every 12 weeks for patients weighing >100kg subcutaneously

and o Patient is not receiving Stelara in combination with any of the

following:

Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]


Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)] o Authorization is for no more than 12 months.

Psoriatic arthritis when ALL of the following criteria are met:

For initial therapy, all of the following: o Diagnosis of psoriatic arthritis; and o Stelara is initiated and titrated according to US Food and Drug

Administration labeled dosing for psoriatic arthritis up to a maximum of 90mg every 12 weeks subcutaneously (or equivalent dose and interval schedule); and

o Physician attestation that the patient or caregiver is not competent to administer Stelara FDA labeled for self-administration; physician must submit explanation; and

o Patient is not receiving Stelara in combination with any of the

following: Biologic DMARD [e.g., Enbrel (etanercept), Humira

(adalimumab), Cimzia (certolizumab), Simponi (golimumab)]





REVISED

Stelara®


Oct. 1, 2019

Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

o Initial authorization is for no more than 12 months. For continuation of therapy, all of the following:

o Documentation of positive clinical response; and o Physician attestation that the patient or caregiver is not competent to

administer Stelara FDA labeled for self-administration; physician must submit explanation; and

o Stelara is initiated and titrated according to US Food and Drug

Administration labeled dosing for psoriatic arthritis up to a maximum of 90mg every 12 weeks subcutaneously (or equivalent dose and interval schedule); and

o Patient is not receiving Stelara in combination with any of the following: Biologic DMARD [e.g., infliximab, Humira (adalimumab), Cimzia

(certolizumab), Simponi (golimumab)]

Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] Phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]

o Authorization is for no more than 12 months.

Stelara is unproven and not medically necessary for the treatment of multiple sclerosis.

In available studies, Stelara does not demonstrate efficacy in the treatment of multiple sclerosis.




REVISED

Preventive Care Services

Dec. 1, 2019

Applicable Codes: Preventive Care Services

Hepatitis B Virus Infection Screening

Updated service description for Pregnant Women: o Removed June 2009 USPSTF

“A” rating o Added July 2019 USPSTF “A”

rating to indicate the USPSTF

recommends screening for hepatitis B virus (HBV) infection in pregnant women at their first prenatal visit

Newborn Screenings Updated service description;

removed July 2008 USPSTF “B”

rating Removed list of applicable

CPT/HCPCS codes for Hearing

Screening: 92551, 92558, 92585, 92586, 92587, 92588, and V5008

Osteoporosis Screening

Updated list of applicable CPT codes; removed 77078

Screening for Visual Impairment

in Children Updated service

description/Bright Futures

recommendation to indicate: o Visual acuity screening is

recommended for age 4 and 5 years, as well as in

cooperative 3 year olds o Instrument-based screening

is recommended for age 12

and 24 months, in addition to the well visits at age 3

Indications for Coverage

Introduction

UnitedHealthcare covers certain medical services under the preventive care services benefit. The federal Patient Protection and Affordable Care Act (PPACA) requires non-grandfathered health plans to cover certain

“recommended preventive services” as identified by PPACA under the preventive care services benefit, without cost sharing to members when provided by network physicians. This includes:

Evidence-based items or services that have in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force.

Immunizations for routine use in children, adolescents and adults that

have in effect a recommendation from the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention.

With respect to infants, children and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive

guidelines supported by the Health Resources and Services

Administration. With respect to women, such additional preventive care and screenings

as provided for in comprehensive guidelines supported by the Health Resources and Services Administration.

Member Cost-Sharing

Non-Grandfathered Plans: o Non-grandfathered plans provide coverage for preventive care

services with no member cost sharing (i.e., covered at 100% of Allowed Amounts without deductible, coinsurance or copayment) when services are obtained from a Network provider.

o Under PPACA, services obtained from an out-of-network provider are not required to be covered under a plan’s preventive benefit, and may be subject to member cost sharing. Refer to the member specific benefit plan document for out-of-network benefit

information, if any. Grandfathered Plans:

o Plans that maintain grandfathered status under PPACA are not

required by law to provide coverage for these preventive services without member cost sharing; although a grandfathered plan may




REVISED

Preventive Care

Services (continued)

Dec. 1, 2019

through 5 years

Revised preventive benefit instructions/age limit guidelines to indicate: o Visual acuity screening

(CPT code 99173): Up to age 21 years (ends on 22nd birthday); does not have

diagnosis code requirements for preventive benefits to apply

o Instrument-based screening (CPT codes 99174 and 99177): Age 1 to 5 (ends on 6th

birthday); does not have diagnosis code

requirements for

preventive benefits to apply

Age 6 to 21 years (ends

on 22nd birthday); refer to the Medical Policy titled Omnibus Codes for allowable diagnoses

Hearing Tests (Bright Futures) Updated list of applicable codes:

o Added CPT/HCPCS codes

92558, 92585, 92586, 92587, 92588, and V5008

o Added ICD-10 diagnosis

codes Z00.00 and Z00.01

choose to voluntarily amend its plan document to include these

preventive benefits. o Except where there are state mandates, a grandfathered plan might

include member cost sharing, or exclude some of the preventive care services identified under PPACA.

o Refer to the member specific benefit plan document for details on how benefits are covered under a grandfathered plan.

Preventive vs. Diagnostic Services

Certain services can be done for preventive or diagnostic reasons. When a service is performed for the purpose of preventive screening and is appropriately reported, it will be considered under the preventive care

services benefit. This includes services directly related to the performance of a covered preventive care service (see the Frequently Asked Questions section of the policy for additional information.)

Preventive services are those performed on a person who:

has not had the preventive screening done before and does not have symptoms or other abnormal studies suggesting abnormalities; or

has had screening done within the recommended interval with the findings considered normal; or

has had diagnostic services results that were normal after which the

physician recommendation would be for future preventive screening studies using the preventive services intervals.

When a service is done for diagnostic purposes it will be considered under the

applicable non-preventive medical benefit. Diagnostic services are done on a person who: had abnormalities found on previous preventive or diagnostic studies that

require further diagnostic studies; or had abnormalities found on previous preventive or diagnostic studies that

would recommend a repeat of the same studies within shortened time

intervals from the recommended preventive screening time intervals; or had a symptom(s) that required further diagnosis; or does not fall within the applicable population for a recommendation or

guideline

Covered Breastfeeding Equipment

Personal-use electric breast pump:




REVISED

Preventive Care


Dec. 1, 2019

The purchase of a personal-use electric breast pump (HCPCS code

E0603). o This benefit is limited to one pump per birth. In the case of a birth

resulting in multiple infants, only one breast pump is covered. o A breast pump purchase includes the necessary supplies for the

pump to operate. Replacement breast pump supplies necessary for the personal-use

electric breast pump to operate. This includes: standard power adaptor,

tubing adaptors, tubing, locking rings, bottles specific to breast pump operation, caps for bottles that are specific to the breast pump, valves, filters, and breast shield and/or splash protector for use with the breast

pump. Coverage Limitations and Exclusions

Services not covered under the preventive care benefit may be covered under another portion of the medical benefit plan.

The coverage outlined in this guideline does not address certain

outpatient prescription medications, tobacco cessation drugs and/or over the counter items, as required by PPACA. These preventive benefits are administered by the member’s pharmacy plan administrator. For details

on coverage, refer to the member-specific pharmacy plan administrator. A vaccine (immunization) is not covered if it does not meet company

vaccine policy requirements for FDA labeling and if it does not have explicit ACIP recommendations for routine use published in the Morbidity

and Mortality Weekly Report (MMWR) of the Centers for Disease Control and Prevention (CDC).

Examinations, screenings, testing, or vaccines (immunizations) are not

covered when: o required solely for the purposes of career or employment, school or

education, sports or camp, travel (including travel vaccines

(immunizations)), insurance, marriage or adoption; or o related to judicial or administrative proceedings or orders; or o conducted for purposes of medical research; or o required to obtain or maintain a license of any type.

Services that are investigational, experimental, unproven or not medically necessary are not covered.

Breastfeeding equipment and supplies not listed above. This includes, but

is not limited to: o Manual breast pumps and all related equipment and supplies.




REVISED

Preventive Care


Dec. 1, 2019 o Hospital-grade breast pumps and all related equipment and supplies.

o Equipment and supplies not listed in the Covered Breastfeeding Equipment section above, including but not limited to: Batteries, battery-powered adaptors, and battery packs. Electrical power adapters for travel.

Bottles which are not specific to breast pump operation. This includes the associated bottle nipples, caps and lids.

Travel bags, and other similar travel or carrying accessories.

Breast pump cleaning supplies including soap, sprays, wipes, steam cleaning bags and other similar products.

Baby weight scales.

Garments or other products that allow hands-free pump operation.

Breast milk storage bags, ice-packs, labels, labeling lids, and other similar products.

Nursing bras, bra pads, breast shells, nipple shields, and other similar products.

Creams, ointments, and other products that relieve breastfeeding

related symptoms or conditions of the breasts or nipples.

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/preventive-care-services-12012019.pdf

https://www.uhcprovider.com/content/dam/provider/docs/public/policies/index/commercial/preventive-care-services-12012019.pdf

october 2019 medical policy update bulletin · in this issue 3 medical policy update bulletin:...

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