08/01/17: commercial medical policy update bulletin ... · 2 medical policy update bulletin: august...

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.

August 2017

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

Updated Aug. 15 2017:

Page 38 & 39: Modified coverage rationale for policies titled Brineura™ (Cerliponase Alfa) and Radicava™ (Edaravone) (effective Sep. 1, 2017); removed notation indicating policy guidelines apply to requests for coverage for dates of service on or after Oct. 1, 2017

2 Medical Policy Update Bulletin: August 2017

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 service, procedure, test, or

device

Updated

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

to the clinical coverage criteria or documentation review requirements;

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

list(s) of applicable codes may have been updated

Revised

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

the clinical coverage criteria and/or documentation review requirements

Replaced

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

Retired

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

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

necessary and are therefore not excluded as unproven/not medically

necessary services, unless coverage guidelines or criteria are otherwise

documented in another policy

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

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

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

applicable federal or state regulatory requirements. Additionally,

UnitedHealthcare reserves the right to review the clinical evidence

supporting the safety and effectiveness of a medical technology prior to

rendering a coverage determination.

This bulletin provides complete details on UnitedHealthcare Medical

Policy, 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 > Menu

> 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

Medical Policy Updates Page

NEW

Laser Interstitial Thermal Therapy - Effective Oct. 1, 2017 .................................................................................................................................... 5

UPDATED

Chemosensitivity and Chemoresistance Assays in Cancer - Effective Sep. 1, 2017 .................................................................................................... 5 Cytological Examination of Breast Fluids for Cancer Screening - Effective Aug. 1, 2017 ............................................................................................. 5 Discogenic Pain Treatment - Effective Aug. 1, 2017 .............................................................................................................................................. 6 Electrical Bioimpedance for Cardiac Output Measurement - Effective Aug. 1, 2017 .................................................................................................... 7 Occipital Neuralgia and Headache Treatment - Effective Aug. 1, 2017 ..................................................................................................................... 7 Osteochondral Grafting - Effective Sep. 1, 2017 ................................................................................................................................................... 9 Spinal Ultrasonography - Effective Aug. 1, 2017 ................................................................................................................................................. 10 Total Artificial Heart - Effective Aug. 1, 2017 ...................................................................................................................................................... 11

REVISED

Apheresis - Effective Oct. 1, 2017 ..................................................................................................................................................................... 11 Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes - Effective Sep. 1, 2017 ......................................................................... 22 Functional Endoscopic Sinus Surgery (FESS) - Effective Oct. 1, 2017 .................................................................................................................... 25 Neuropsychological Testing Under the Medical Benefit - Effective Sep. 1, 2017 ....................................................................................................... 25 Omnibus Codes - Effective Oct. 1, 2017 ............................................................................................................................................................ 28 Proton Beam Radiation Therapy - Effective Sep. 1, 2017 ..................................................................................................................................... 35

Medical Benefit Drug Policy Updates

NEW

Brineura™ (Cerliponase Alfa) - Effective Sep. 1, 2017 ......................................................................................................................................... 38 Radicava™ (Edaravone) - Effective Sep. 1, 2017 ................................................................................................................................................ 39 White Blood Cell Colony Stimulating Factors - Effective Sep. 1, 2017 .................................................................................................................... 40

REVISED

Clotting Factors and Coagulant Blood Products - Effective Sep. 1, 2017 ................................................................................................................. 43 Infliximab (Remicade®, Inflectra™, Renflexis™) - Effective Sep. 1, 2017 ............................................................................................................... 44 Repository Corticotropin Injection (H.P. Acthar Gel®) - Effective Sep. 1, 2017 ........................................................................................................ 47



In This Issue

Coverage Determination Guideline (CDG) Updates

UPDATED

Home Health Care - Effective Sep. 1, 2017 ........................................................................................................................................................ 49 Skilled Care and Custodial Care Services - Effective Sep. 1, 2017 ......................................................................................................................... 50

REVISED

Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements - Effective Oct. 1, 2017 ..................................... 51 Preventive Care Services - Effective Oct. 1, 2017 ............................................................................................................................................... 52 Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs - Effective Oct. 1, 2017 .......................................................................... 53

Utilization Review Guideline (URG) Updates

REVISED

Office Based Program - Effective Oct. 1, 2017 .................................................................................................................................................... 61 Specialty Medication Administration – Site of Care Review Guidelines - Effective Sep. 1, 2017 ................................................................................. 62


Medical Policy Updates

Policy Title Effective Date Coverage Rationale

NEW

Laser Interstitial Thermal Therapy

Oct. 1, 2017 Laser interstitial thermal therapy is considered unproven and not medically necessary for treating ANY condition or diagnosis, including but not limited to: Brain tumors

Breast tumors (i.e., benign or malignant) Epilepsy (e.g., drug-resistant epilepsy, focal cortical dysplasias, mesial temporal lobe epilepsy) Prostate cancer

Radiation necrosis There is insufficient published evidence in the clinical literature supporting the safety and efficacy of this minimally invasive surgical procedure. Further studies are needed to determine whether such treatment is beneficial for health

outcomes.

Policy Title Effective Date Summary of Changes Coverage Rationale

UPDATED

Chemosensitivity

and Chemoresistance

Assays in Cancer

Sep. 1, 2017 Updated list of applicable CPT

codes; added 81535 and 81536 Updated supporting information

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

Chemosensitivity assays and chemoresistance assays are unproven

and not medically necessary for predicting response to chemotherapy in patients with cancer.

Results of the available studies fail to provide sufficient evidence that testing with chemoresistance and chemosensitivity assays leads to improved health outcomes in patients with cancer. To date, the majority of the available studies failed to demonstrate a survival benefit with chemotherapy regimens selected based on chemosensitivity and chemoresistance assays, compared

with chemotherapy regimens selected based on traditional clinical factors. Well-designed randomized controlled trials (RCTs) are needed to determine the clinical utility of chemosensitivity and chemoresistance assays compared with traditional clinical factors to guide treatment selection and improve clinical outcomes including tumor response, time to progression and overall survival.

Cytological Examination of Breast Fluids for Cancer Screening

Aug. 1, 2017

Updated supporting information to reflect the most current clinical evidence, CMS information, and references; no change to coverage rationale or

list of applicable codes

Breast ductal lavage is unproven and not medically necessary for use in breast cancer screening of either low-risk or high-risk women. There is inadequate clinical evidence that breast ductal lavage either allows for better clinical decision-making or reduces breast cancer mortality. Further studies are necessary to determine the efficacy of cytological examination of

ductal fluid in detecting atypical cells to identify women at increased risk of breast cancer as well as comparing the results to established methods of detecting and diagnosing breast cancer. Ductal lavage is intended for use in high-risk women but no definite patient selection criteria for ductal lavage of




UPDATED

Cytological Examination of Breast Fluids for

Cancer Screening (continued)

Aug. 1, 2017 the breast have been established. Breast ductal fluid aspiration and cytology is unproven and not

medically necessary for use in breast cancer screening of either low-risk or high-risk women. There is inadequate clinical evidence that automated nipple aspiration either

allows for better clinical decision-making or reduces breast cancer mortality. Further studies are necessary to determine the efficacy of cytological examination of ductal fluid in detecting atypical cells to identify women at increased risk of breast cancer as well as comparing the results to

established methods of detecting and diagnosing breast cancer. Fiberoptic ductoscopy, with or without ductal lavage, is unproven and not medically necessary for use in breast cancer diagnosis or screening or as an intraoperative tool to guide surgery. There is insufficient clinical evidence demonstrating that fiberoptic

ductoscopy allows for better clinical decision-making, reduces breast cancer mortality or serves as a useful adjunct to or replacement of open surgical

excision.

Discogenic Pain Treatment

Aug. 1, 2017

Updated supporting information to reflect the most current

description of services, clinical evidence, FDA information, and references; no change to coverage rationale or lists of applicable codes

Thermal intradiscal procedures (TIPs) are unproven and not medically necessary for treating discogenic pain.

TIPs include the following procedures: Intradiscal electrothermal therapy (IDET) Intradiscal biacuplasty (IDB) Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) Percutaneous intradiscal annuloplasty Percutaneous discectomy and decompression procedures are

unproven and not medically necessary for treating discogenic pain.

Percutaneous discectomy and decompression procedures include, but are not limited to, the following procedures: Nucleoplasty [percutaneous disc decompression (PDD) or percutaneous

plasma discectomy] Laser discectomy [laser disc decompression (PLDD); laser-assisted disc

decompression (LADD); or percutaneous endoscopic discectomy, with or without laser (PELD)]

Yeung endoscopic spinal surgery (YESS) [arthroscopic microdiskectomy or percutaneous endoscopic diskectomy (PELD)]




UPDATED

Discogenic Pain Treatment (continued)

Aug. 1, 2017 Transforaminal (TESSYS®) and/or interlaminar (iLESSYS®) [transforaminal and interlaminar approach]

Overall, the evidence regarding the efficacy of TIPs and percutaneous discectomy procedures for the treatment of low back pain is insufficient to demonstrate beneficial health outcomes. Available clinical studies are

weakened by the lack of randomization, lack comparator groups, and lack of long-term follow-up. Well-designed studies with larger patient populations are needed to evaluate the relative safety and effectiveness of these procedures.

Annulus fibrosus repair following spinal surgery is unproven and not medically necessary. Further studies are needed to establish whether annulus fibrosus repair is beneficial for health outcomes in patients with low back pain following spinal surgery.

Electrical

Bioimpedance for Cardiac Output Measurement

Aug. 1, 2017 Updated supporting information

to reflect the most current clinical evidence and references; no change to coverage rationale or list of applicable codes

Electrical bioimpedance is unproven and not medical necessary for

measuring cardiac output. Definitive patient selection criteria for the use of electrical bioimpedance have not been established for measurement of cardiac output, primarily due to inadequate evidence regarding the impact of cardiac output monitoring on

patient management or clinical outcomes. Further research is needed to confirm whether electrical bioimpedance can offer comparable clinical utility regarding cardiac function as thermodilution catheterization (TDC).

Occipital Neuralgia

and Headache Treatment

Aug. 1, 2017

Updated supporting information

to reflect the most current clinical evidence and references; no change to coverage rationale

or lists of applicable codes

Injection of local anesthetics and/or steroids, used as occipital nerve

blocks, is proven and medically necessary for treating pain due to malignancy involving the head and neck.

Injection of local anesthetics and/or steroids, used as occipital nerve blocks, is unproven and not medically necessary for diagnosing and treating occipital neuralgia or headaches including migraine and cervicogenic headaches.

There is insufficient evidence that greater occipital nerve blocks can be used as a specific diagnostic test for occipital neuralgia or headaches. The efficacy of local injection therapies for occipital neuralgia or cervicogenic headache and other headaches has not been established in well-designed clinical trials.




UPDATED

Occipital Neuralgia and Headache Treatment

(continued)

Aug. 1, 2017

See the Medical Benefit Drug Policy titled Botulinum Toxins A and B for information regarding the use of botulinum toxin for treatment of headaches.

Surgery including but not limited to the following is unproven and not medically necessary for treating occipital neuralgia or cervicogenic headache:

Occipital neurectomy Partial posterior intradural C1-C3 rhizotomy Rhizotomy of C1-C3 spinal dorsal roots Surgical decompression of second cervical nerve root and ganglion

Surgical decompression of the greater occipital nerve The available evidence is insufficient to conclude that surgery is an effective treatment for occipital neuralgia or cervicogenic headaches. The long-term efficacy of surgical procedures for occipital neuralgia or cervicogenic headaches has not been established in well-designed clinical trials.

Occipital neurectomy or surgical nerve decompression is unproven

and not medically necessary for treating headaches. The available evidence is insufficient to conclude that occipital neurectomy or nerve decompression including decompression of the supraorbital, supratrochlear, zygomaticotemporal, or greater occipital nerves is an effective treatment for headaches. The long-term efficacy of these

procedures for headaches has not been established in well-designed clinical trials. Radiofrequency ablation (thermal or pulsed) or denervation is unproven and not medically necessary for treating of occipital neuralgia or headaches including migraine, cluster and cervicogenic headache.

The available evidence from published studies is not sufficient to conclude that radiofrequency ablation or denervation is an effective treatment for occipital neuralgia or headaches. Well-designed studies are needed to evaluate the potential advantages of radiofrequency ablation for these conditions and to identify which patients would benefit from this procedure.

Neurostimulation or electrical stimulation is unproven and not medically necessary for treating of occipital neuralgia or headaches including migraine, cluster and cervicogenic headache.




UPDATED

Occipital Neuralgia and Headache Treatment

(continued)

Aug. 1, 2017 The available studies were limited and had significant methodological flaws, making it difficult to draw conclusions regarding the efficacy of electrical stimulation for the treatment of headache or occipital neuralgia. There are no

well-designed randomized controlled studies in the medical literature comparing neurostimulation to established treatment options or a sham procedure. Studies on larger populations with longer follow-up are needed to

establish the benefits of neurostimulation and electrical stimulation for treating these conditions.

Osteochondral Grafting

Sep. 1, 2017

Changed policy title; previously titled Osteochondral Grafting of Knee

Updated list of applicable CPT codes; added 28446


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

Osteochondral autograft transplantation is proven and medically necessary for treating cartilage defects of the knee when ALL of the following criteria are met: Adult who has achieved mature skeletal growth with documented closure

of growth plates Symptomatic focal full-thickness articular cartilage defect

Considered unsuitable candidate for total knee replacement Presence of debilitating symptoms that significantly limit ambulation Normal alignment or correctable varus or valgus deformities`

Minimal to absent degenerative changes in surrounding articular cartilage (Outerbridge Grade II or less)

Failed conventional medical treatment (including physical therapy and/or bracing techniques) and/or prior surgical treatment

Willingness to comply with extensive period of rehabilitation following surgery

Osteochondral autograft transplantation for all other joints, and any indications other than those listed above, is considered unproven and not medically necessary. The peer-reviewed scientific literature regarding the treatment of

osteochondral defects in joints other than the knee is limited. Additional

studies are needed to establish the appropriateness of the treatment of these osteochondral defects. Osteochondral allograft transplantation using human cadaver tissue is proven and medically necessary for treating cartilage defects of

the knee when ALL of the following criteria are met: Adult who has achieved mature skeletal growth with documented closure

of growth plates Symptomatic focal full-thickness articular cartilage defect




UPDATED

Osteochondral Grafting (continued)

Sep. 1, 2017 Considered unsuitable candidate for total knee replacement Presence of debilitating symptoms that significantly limit ambulation Normal alignment or correctable varus or valgus deformities

Minimal to absent degenerative changes in surrounding articular cartilage (Outerbridge Grade II or less)

Failed conventional medical treatment (including physical therapy and/or

bracing techniques) and/or prior surgical treatment

Willingness to comply with extensive period of rehabilitation following

surgery Osteochondral allograft transplantation for all other joints, and any indications other than those listed above, is considered unproven and not medically necessary. The peer-reviewed scientific literature regarding the treatment of

osteochondral defects in joints other than the knee is limited. Additional studies are needed to establish the appropriateness of the treatment of these osteochondral defects.

Minced articular cartilage repair (allograft or autograft) is unproven and not medically necessary for treating osteochondral defects of the

knee. Randomized trials that compare the outcomes of minced articular cartilage repair with standard methods have not been published. Clinical studies are needed to establish the safety and outcome benefit of this technique over standard methods of cartilage repair.

Spinal Ultrasonography

Aug. 1, 2017

Updated supporting information to reflect the most current description of services, clinical evidence, CMS information, and

references; no change to coverage rationale or list of applicable codes

Spinal and paraspinal ultrasonography is proven and medically necessary in newborns and infants for evaluating and managing suspected spinal disorders (e.g., congenital cord anomalies, spinal cord tumors, vascular malformations and birth-related trauma).

Spinal and paraspinal ultrasonography (including extremities, pelvis, or soft tissues of the head and neck) are unproven and not medically

necessary for the following uses: To diagnose and manage spinal pain and radiculopathies To guide rehabilitation of neuromusculoskeletal disorders and spinal pain There is insufficient evidence in the peer-reviewed medical literature to establish the efficacy or clinical value of spinal and paraspinal




UPDATED

Spinal Ultrasonography (continued)

Aug. 1, 2017 ultrasonography as a diagnostic tool in the management of back pain, radiculopathies or for monitoring of therapies. The use of ultrasound imaging to guide rehabilitation is under investigation. More research is needed to

define the role of rehabilitative ultrasound imaging.

Total Artificial

Heart

Aug. 1, 2017 Updated supporting information

to reflect the most current clinical evidence, FDA information, and references; no

change to coverage rationale or list of applicable codes

The SynCardia™ temporary Total Artificial Heart (formerly known as

the CardioWest™ temporary Total Artificial Heart) is proven and medically necessary as a bridge to heart transplantation in patients who meet ALL of the following criteria:

At risk of imminent death from biventricular failure Have no other medical or surgical treatment options Eligible for heart transplantation Have sufficient space in the chest cavity to accommodate the device.

Generally this includes patients who have a body surface area ≥ 1.7m2.

Notes: At this time, only the 70cc SynCardia device has been approved by the

U.S. Food and Drug Administration (FDA).

The Freedom® portable driver system is FDA approved for use with the SynCardia device in clinically stable patients. See the U.S. Food and Drug Administration (FDA) section of the poliy for additional information.

Also see the U.S. Food and Drug Administration (FDA) section of the

policy for additional information on humanitarian device exemptions pending FDA approval. Depending on the member specific benefit plan document, coverage may be available through participation in an eligible clinical trial.


REVISED

Apheresis

Oct. 1, 2017

Revised coverage rationale: o Removed references to

specific apheresis-based procedures; added reference link to Description of

Services section of the policy for applicable information

o Updated list of conditions/diagnoses for

Therapeutic apheresis is proven and medically necessary for treating or managing the following conditions/diagnoses: ABO incompatible heart transplantation in children less than 40 months

of age ABO incompatible major hematopoietic stem cell transplant (marrow)

ABO incompatible kidney transplantation, antibody mediated rejection or LD desensitization

Acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome), primary treatment




REVISED

Apheresis (continued)

Oct. 1, 2017

which therapeutic apheresis is proven and medically necessary:

Added: - Acute liver failure

(requiring high

volume plasma exchange)

- Age related macular degeneration, dry

- Hereditary hemochromatosis

- Hyperlipoproteinemia - Idiopathic dilated

cardiomyopathy, NYHA class II-IV

- Pediatric autoimmune

neuropsychiatric disorders associated with streptococcal infections (PANDAS exacerbation)

- Peripheral vascular diseases

- Polycythemia vera; erythrocytosis

Removed: - Babesiosis - Cryoglobulinemia

- Renal transplantation, desensitization, living or deceased donor recipients, positive crossmatch

due to donor specific HLA antibody

Replaced:

Acute liver failure (requiring high volume plasma exchange) Age-related macular degeneration, dry ANCA-associated rapidly progressive glomerulonephritis, dialysis

dependent (Granulomatosis with polyangiitis; and Microscopic Polyangiitis)

Anti-glomerular basement membrane disease, dialysis independent

(Goodpasture’s syndrome) Cardiac allograft rejection, recurrent Chronic inflammatory demyelinating polyneuropathy Cutaneous T-cell lymphoma; mycosis fungoides; Sezary syndrome,

erythrodermic Familial hypercholesterolemia, heterozygous or homozygous) Focal segmental glomerulosclerosis, recurrent Graft-versus-host disease, skin and non-skin, chronic Hereditary hemochromatosis Hyperleukocytosis, symptomatic

Hyperlipoproteinemia Hyperviscosity in monoclonal gammopathies, symptomatic

Idiopathic dilated cardiomyopathy, NYHA class II-IV IgG/IgA, or IgM type of paraproteinemic polyneuropathy Lung allograft rejection Multiple sclerosis (acute CNS inflammatory, demyelinating) Myasthenia gravis, moderate-severe

Neuromyelitis optica spectrum disorders, acute (Devic’s syndrome) Pediatric autoimmune neuropsychiatric disorders associated with

streptococcal infections (PANDAS exacerbation) Peripheral vascular diseases Polycythemia vera; erythrocytosis Renal transplantation, antibody mediated rejection or LD desensitization Rheumatoid arthritis, refractory

Sickle cell disease, acute (stroke prophylaxis/iron overload prevention) Thrombotic thrombocytopenic purpura Therapeutic apheresis including plasma exchange, plasmapheresis, or photopheresis is unproven and not medically necessary for treating or managing the following conditions/diagnoses, including

but not limited to: ABO incompatible kidney transplantation, A²/A²B into B, deceased donor ABO incompatible liver transplantation, desensitized ABOi, deceased




REVISED


Oct. 1, 2017

- “ABO incompatible hematopoietic stem cell and bone

marrow transplant” with “ABO incompatible major

hematopoietic stem cell transplant (marrow)”

- “ABO incompatible

kidney transplantation” with “ABO incompatible kidney transplantation, antibody mediated

rejection or LD desensitization”

- “Acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome)” with

“acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome), primary treatment”

- “ANCA-associated

rapidly progressive glomerulonephritis (Wegener’s granulomatosis)” with “ANCA-associated rapidly

progressive glomerulonephritis, dialysis dependent

donor or antibody mediated rejection Acute disseminated encephalomyelitis Acute inflammatory demyelinating polyneuropathy (Guillain-Barré

syndrome), after IVIG Amyloidosis, systemic Amyotrophic lateral sclerosis

ANCA-associated rapidly progressive glomerulonephritis, dialysis independent or with diffuse alveolar hemorrhage (DAH) (Granulomatosis with polyangiitis; and Microscopic Polyangiitis)

Anti-glomerular basement membrane disease, dialysis dependent,

with/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 (desensitization, antibody mediated rejection) Catastrophic antiphospholipid syndrome Chronic focal encephalitis (Rasmussen’s encephalitis) Coagulation factor inhibitors Complex regional pain syndrome

Cryoglobulinemia Cutaneous T-cell lymphoma; mycosis fungoides; Sézary syndrome, non-

erythrodermic Dermatomyositis/polymyositis Erythropoietic porphyria, liver disease Familial hypercholesterolemia, homozygous with small blood volume Focal segmental glomerulosclerosis, native kidney, steroid resistant

Graft-versus-host disease, skin and non-skin, acute Hashimoto’s encephalopathy HELLP syndrome Hematopoietic stem cell transplantation, HLA desensitized or ABO

incompatible (major or minor HPC(A)) Hemolytic uremic syndrome

Hemophagocytic lymphohistiocytosis Henoch-Schonlein purpura Heparin induced thrombocytopenia and thrombosis




REVISED


Oct. 1, 2017

(granulomatosis with polyangiitis; and microscopic

polyangiitis)” - “Anti-glomerular

basement membrane

disease (Goodpasture’s syndrome)” with “anti-glomerular

basement membrane disease, dialysis independent (Goodpasture’s syndrome)”

- “Cardiac allograft

rejection or prophylaxis of

cardiac transplant rejection” with “cardiac allograft rejection, recurrent”

- “Heterozygous or

homozygous familial hypercholesterolemia” with “familial hypercholesterolemia, heterozygous or homozygous”

- “Graft-versus-host

disease, skin, chronic” with “graft-versus-host disease, skin and non-skin, chronic”

- “Hyperleukocytosis,

leukostasis” with “hyperleukocytosis, symptomatic”

Hyperleukocytosis, prophylaxis Hypertriglyceridemic pancreatitis Hyperviscosity in monoclonal gammopathies, prophylaxis for rituximab

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

Immune thrombocytopenia

Immunoglobulin A nephropathy Inflammatory bowel disease Lambert-Eaton myasthenic syndrome Lung transplantation

Malaria Multiple sclerosis (unless noted above as proven) Myasthenia gravis, pre-thymectomy Myeloma cast nephropathy Nephrogenic systemic fibrosis Neuromyelitis optica spectrum disorders, maintenance

N-methyl D-aspartate receptor antibody encephalitis Overdose, venoms, and poisoning

Paraneoplastic neurologic syndromes Paraproteinemic polyneuropathy, multiple indications (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) Polycythemia vera, secondary erythrocytosis Post transfusion purpura Prevention of RhD alloimmunization after RBC exposure Progressive multifocal leukoencephalopathy associated with natalizumab Pruritus due to hepatobiliary diseases

Psoriasis Red cell alloimmunization in pregnancy Renal transplantation, ABO compatible, desensitized, deceased donor Scleroderma (systemic sclerosis) Sepsis with multiorgan failure Sickle cell disease, acute or non-acute (unless noted above as proven)

Stiff-person syndrome Sudden sensorineural hearing loss Systemic lupus erythematosus




REVISED


Oct. 1, 2017

- “Hyperviscosity in monoclonal gammopathies,

treatment of symptoms” with “hyperviscosity in

monoclonal gammopathies, symptomatic”

- “Multiple sclerosis

(relapsing form with steroid resistant exacerbations) Myasthenia gravis” with “multiple sclerosis (acute CNS

inflammatory, demyelinating)

Myasthenia gravis, moderate-severe”

- “Neuromyelitis optica (Devic’s syndrome)” with “neuromyelitis

optica spectrum disorders, acute (Devic’s syndrome)”

- “Renal transplantation, antibody mediated rejection” with “renal

transplantation, antibody mediated rejection or LD desensitization”

- “Sickle cell disease for (1) red blood cell

exchange for treating acute stroke, acute chest

Thrombocytosis Thrombotic microangiopathy, all indications Thyroid storm

Toxic epidermal necrolysis Vasculitis Voltage gated potassium channel antibodies

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

outcomes such as decreased morbidity and mortality rates in patients with disorders other than those listed as proven. Note: Please see Description of Services section for information regarding all apheresis-based procedures.

Apheresis is proven and medically necessary as first-line therapy when treating or managing the following conditions/diagnoses:

Acute inflammatory demyelinating polyneuropathy (Guillain-Barré syndrome)

ANCA-associated rapidly progressive glomerulonephritis (Wegener’s Granulomatosis)

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

Babesiosis Cardiac allograft rejection prophylaxis Chronic inflammatory demyelinating polyneuropathy Cryoglobulinemia Cutaneous T-cell lymphoma; mycosis fungoides; Se’zary syndrome,

erythrodermic Homozygous familial hypercholesterolemia

Hyperleukocytosis, leukostasis Hyperviscosity in monoclonal gammopathies, treatment of symptoms IgG/IgA, or IgM type of paraproteinemic polyneuropathy Myasthenia gravis Renal transplantation, antibody mediated rejection Renal transplantation, desensitization, living or deceased donor

recipients, positive crossmatch due to donor specific HLA antibody Sickle cell disease for one of the following: Treatment of acute stroke or multiorgan failure




REVISED


Oct. 1, 2017

syndrome, or multiorgan failure; or (2) prophylaxis with

red blood cell exchange for primary or secondary stroke

prevention or for prevention of transfusional iron overload” with

“sickle cell disease, acute (stroke prophylaxis/iron overload prevention)”

o Updated list of

conditions/diagnoses for which therapeutic apheresis

is unproven and not medically necessary: Added:

- ABO incompatible kidney

transplantation, A²/A²B into B, deceased donor

- Acute inflammatory demyelinating polyneuropathy (Guillain-Barré

syndrome), after IVIG

- ANCA-associated rapidly progressive glomerulonephritis, dialysis independent

or with diffuse alveolar hemorrhage (DAH)

Primary or secondary stroke prevention or for prevention of transfusional iron overload

Thrombotic thrombocytopenic purpura

Apheresis is proven and medically necessary as second-line therapy when treating or managing the following conditions/diagnoses in

persons who are refractory to or intolerant of standard therapy: ABO incompatible heart transplantation in children less than 40 months

of age ABO incompatible hematopoietic stem cell and bone marrow transplant

ABO incompatible kidney transplantation Cardiac allograft rejection Focal segmental glomerulosclerosis, recurrent Heterozygous familial hypercholesterolemia Graft-versus-host disease, skin, chronic Lung allograft rejection

Multiple sclerosis (relapsing form with steroid resistant exacerbations) Neuromyelitis optica (Devic’s syndrome)

Rheumatoid arthritis, refractory Sickle cell disease, acute chest syndrome




REVISED


Oct. 1, 2017

(Granulomatosis with polyangiitis; and Microscopic

Polyangiitis) - Anti-glomerular

basement membrane

disease, dialysis dependent, with/without DAH (Goodpasture’s

syndrome) - Atopic (neuro-)

dermatitis (atopic eczema), recalcitrant

- Babesiosis - Cardiac neonatal

lupus - Cardiac

transplantation (desensitization, antibody mediated rejection)

- Complex regional

pain syndrome - Cryoglobulinemia - Erythropoietic

porphyria, liver disease

- Familial hypercholesterol-

emia, homozygous with small blood volume

- Focal segmental glomerulosclerosis, native kidney,

steroid resistant - Hashimoto’s

encephalopathy




REVISED


Oct. 1, 2017

- HELLP syndrome - Hematopoietic stem

cell transplantation,

HLA desensitized or ABO incompatible [major or minor

HPC(A)] - Hemophagocytic

lymphohistiocytosis - Henoch-Schonlein

purpura - Heparin induced

thrombocytopenia and thrombosis

- Immunoglobulin A nephropathy

- Lung transplantation - Myasthenia gravis,

pre-thymectomy - Neuromyelitis optica

spectrum disorders, maintenance

- N-methyl D-

aspartate receptor antibody encephalitis

- Paraproteinemic polyneuropathy, multiple indications (unless noted in the policy as proven)

- Prevention of RhD alloimmunization after RBC exposure

- Progressive multifocal leukoencephalopathy

associated with natalizumab

- Pruritus due to




REVISED


Oct. 1, 2017

hepatobiliary diseases

- Renal

transplantation, ABO compatible, desensitized,

deceased donor - Sickle cell disease,

acute or non-acute (unless noted in the

policy as proven) - Sudden

sensorineural hearing loss

- Toxic epidermal necrolysis

- Vasculitis - Voltage gated

potassium channel antibodies

Removed: - Acute liver failure - Age related macular

degeneration - Dilated

cardiomyopathy - Graft-versus-host

disease, non-skin, acute/chronic

- Hereditary

hemochromatosis - High density

lipoprotein (HDL) delipidation and plasma reinfusion

- Immune complex

rapidly progressive glomerulonephritis

- Inclusion body




REVISED


Oct. 1, 2017

myositis - Multiple myeloma

type of

paraproteinemic polyneuropathy

- POEMS

(polyneuropathy, organomegaly, endocrinopathy, M protein, and skin

changes) - Rheumatoid arthritis,

refractory, treated with plasma exchange

- Schizophrenia

- Thrombotic microangiopathy:

hematopoietic stem cell transplant-associated

Replaced: - “ABO incompatible

solid organ transplantation, liver perioperative” with “ABO incompatible liver transplantation, desensitized ABOi, deceased donor or

antibody mediated rejection”

- “Graft-versus-host disease, skin, acute” with “graft-versus-host disease, skin

and non-skin, acute” - “Immune

thrombocytopenic




REVISED


Oct. 1, 2017

purpura” with “immune thrombocytopenia”

- “Multiple sclerosis, chronic progressive or secondary

progressive” with “multiple sclerosis (unless noted in the policy as proven)”

- “Pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS)

and Sydenham’s chorea” with

“pediatric autoimmune neuropsychiatric disorders associated with streptococcal

infections (Sydenham’s chorea, severe)”

- “Polycythemia vera and erythrocytosis” with “polycythemia vera, secondary

erythrocytosis" - “Scleroderma

(progressive systemic sclerosis)” with “scleroderma (systemic sclerosis)”

- “Thrombotic microangiopathy: drug-associated”




REVISED


Oct. 1, 2017

with “thrombotic microangiopathy, all indications”

o Reorganized language to clarify apheresis is proven and medically necessary as

second-line therapy when treating or managing the listed conditions/diagnoses in persons who are

refractory to or intolerant of standard therapy

Updated supporting information to reflect the most current description of services, clinical evidence, CMS information, and

references

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Sep. 1, 2017

Updated list of related policies; removed reference link to Medical Policy titled Intermittent Intravenous Insulin Therapy

(retired Feb. 1, 2017) Updated benefit considerations;

removed examples of applicable benefit plan documents

Revised coverage rationale: o Replaced language

indicating:

“External insulin pumps

that deliver insulin by continuous subcutaneous infusion are proven and medically necessary for patients with type 1 or

insulin-requiring type 2 diabetes who currently perform ≥4 insulin injections and ≥4 blood

Insulin Delivery

External insulin pumps that deliver insulin by continuous subcutaneous infusion are proven and medically necessary for patients with type 1 or insulin-requiring type 2 diabetes. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 21st edition, 2017, Insulin Infusion Pump ACG:A-

0339 (AC). Note: Programmable disposable external insulin pumps (e.g., Omnipod) are considered equivalent to standard insulin pumps. Nonprogrammable transdermal insulin delivery systems (e.g., V-Go)

are unproven and not medically necessary for treating patients with

diabetes. There is insufficient evidence in the clinical literature demonstrating the safety and efficacy of transdermal insulin delivery in the management of patients with diabetes. Implantable insulin pumps are investigational, unproven and not

medically necessary. No implantable insulin pumps have received U.S. Food and Drug




REVISED

Continuous Glucose Monitoring and Insulin Delivery for

Managing Diabetes (continued)

Sep. 1, 2017

glucose measurements daily” with “external insulin pumps that

deliver insulin by continuous subcutaneous infusion are proven and

medically necessary for patients with type 1 or insulin-requiring type 2 diabetes”

“Long-term continuous glucose monitoring for personal use at home is proven and medically necessary as a supplement to self-

monitoring of blood glucose (SMBG) for

patients with type 1 diabetes who have demonstrated adherence to a physician ordered diabetic treatment plan”

with “long-term continuous glucose monitoring for personal use at home is proven and medically necessary for patients with type 1 diabetes who have

demonstrated adherence to a physician ordered diabetic treatment plan”

o Added example of brand name product for: Programmable

disposable external insulin pumps (Omnipod®)

Administration (FDA) approval at this time. While some preliminary studies reported improved glycemic control and fewer episodes of hypoglycemia in carefully selected patients, complications such as catheter blockage and

infection were observed. Larger, randomized controlled trials are needed to determine the long-term impact of implantable insulin pumps on diabetes management.

Insulin infuser ports are unproven and not medically necessary for insulin delivery in patients with diabetes. There is insufficient evidence demonstrating that the use of insulin infuser

ports results in improved glycemic control beyond what can be achieved by using standard insulin delivery methods. In addition, an increase in complications, such as infection at the port site, has been reported when using these devices. Further well-designed, large-scale randomized controlled trials are needed to establish the safety and efficacy of these devices.

See the Description of Services section of the policy for further details on the

various types of insulin delivery systems. Continuous Glucose Monitoring

Short-term (3-7 days) continuous glucose monitoring by a healthcare provider for diagnostic purposes is proven and medically necessary for patients with diabetes.

Long-term continuous glucose monitoring for personal use at home is proven and medically necessary for patients with type 1 diabetes who have demonstrated adherence to a physician ordered diabetic treatment plan. For information regarding medical necessity review, when applicable, see

MCG™ Care Guidelines, 21st edition, 2017, Continuous Glucose Monitoring ACG:A-0126 (AC).

Long-term continuous glucose monitoring for personal use at home is unproven and not medically necessary for patients with type 2 diabetes or gestational diabetes. There is insufficient evidence that the use of long-term continuous glucose monitoring leads to improvement of glycemic control in patients with type 2 or gestational diabetes.




REVISED

Continuous Glucose Monitoring and Insulin Delivery for

Managing Diabetes (continued)

Sep. 1, 2017 Nonprogrammable transdermal insulin delivery systems (V-Go)

Implantable glucose sensors (Eversense®)

o Added language to indicate

continuous glucose monitoring using a noninvasive device is investigational, unproven,

and not medically necessary due to lack of FDA approval There are no

commercially available noninvasive systems at this time

There is insufficient published clinical

evidence to assess the safety and efficacy of continuous glucose monitoring using a noninvasive device

o Removed language indicating remote glucose monitoring is unproven and not medically necessary for managing patients with diabetes

Updated list of applicable HCPCS

codes: o Added K0553 and K0554 o Removed A9275 and E0607

Updated supporting information to reflect the most current description of services, clinical

evidence, FDA and CMS information, and references

Continuous glucose monitoring using an implantable glucose sensor (e.g., Eversense) is investigational, unproven and not medically necessary due to lack of U.S. Food and Drug Administration (FDA)

approval. There is insufficient published clinical evidence to conclude that the use of continuous glucose monitoring using an implantable gluocose sensor leads to

an improvement in glycemic control. The small sample sized studies lack adequate controls, randomization and blinding. Continuous glucose monitoring using a noninvasive device is

investigational, unproven and not medically necessary due to lack of FDA approval. There are no commercially available noninvasive systems at this time. There is insufficient published clinical evidence to assess the safety and efficacy of continuous glucose monitoring using a noninvasive device.




REVISED

Functional Endoscopic Sinus Surgery (FESS)

Oct. 1, 2017 Revised coverage rationale: o Updated coverage criteria for

patients with chronic

rhinosinusitis; replaced criterion requiring “chronic rhinosinusitis is confirmed on

computed tomography (CT) scan” with “chronic rhinosinusitis of the sinus to be operated on is confirmed

on computed tomography (CT) scan”

o Added language to indicate functional endoscopic sinus surgery (FESS) is medically necessary for concha bullosa

documented on CT scan Updated list of applicable CPT

codes; removed 31239 Updated supporting information

to reflect the most current description of services, clinical evidence, FDA information, and

references

Functional endoscopic sinus surgery (FESS) is medically necessary for one or more of the following: Patients with chronic rhinosinusitis (defined as rhinosinusitis lasting

longer than 12 weeks) with both of the following: o Chronic rhinosinusitis of the sinus to be operated on is confirmed on

computed tomography (CT) scan by one or more of the following:

Mucosal thickening Bony remodeling Bony thickening or Obstruction of the ostiomeatal complex

Opacified sinus o Symptoms persist despite medical therapy with one or more of the

following: Nasal lavage Antibiotic therapy, if bacterial infection is suspected Intranasal corticosteroids

Mucocele documented on CT scan Concha bullosa documented on CT scan

Complications of sinusitis such as abscess Tumor documented on CT scan (such as polyposis or malignancy) Recurrent acute rhinosinusitis (RARS) Drug eluting stents or drug eluting implants are unproven and not

medically necessary for maintaining sinus ostial patency after sinus surgery. The evidence is insufficient to determine whether drug eluting sinus stents or drug eluting implants improve outcomes when used postoperatively following endoscopic sinus surgery. Further randomized clinical trials are needed that compare the devices to postoperative care without the device to determine whether they can improve postoperative outcomes for patients undergoing

endoscopic sinus surgery.

Neuropsychological Testing Under the Medical Benefit

Sep. 1, 2017

Revised coverage rationale: o Replaced language

indicating:

“Baseline neuropsychological testing is unproven and not medically necessary

Neuropsychological testing is proven and medically necessary for evaluating patients with the following conditions when the result of testing will influence clinical decision making:

Attention-deficit/hyperactivity disorder (ADHD) when all of the following are present: o Specific neurocognitive behavioral deficits related to ADHD need to

be evaluated and




REVISED


(continued)

Sep. 1, 2017

in asymptomatic persons at risk for sport-related concussions” with

“baseline neuropsychological testing is unproven and

not medically necessary in asymptomatic persons at risk for sport-related concussions or brain

injuries” “Computerized

neuropsychological testing is unproven and not medically necessary when used alone for

evaluating concussions” with “computerized

neuropsychological testing is unproven and not medically necessary for evaluating concussions or brain

injuries” “Computerized cognitive

testing such as Mindstreams® Cognitive Health Assessment and BrainCare™ is investigational,

unproven, and not medically necessary for diagnosing dementia or mild cognitive impairment” with “computerized cognitive

testing including but not limited to Cognivue®, Mindstreams® Cognitive

o Testing has been recommended by a physician and is related or secondary to a known or suspected organic-medical condition resulting from brain injury or disease process (e.g., concussion,

intractable seizure disorder, cancer treatment effects, genetic disorders, inborn errors of metabolism)

The scope of these criteria is applicable only to neuropsychological

testing that is covered by the medical benefit. These criteria do not apply to evaluate or determine educational interventions.

Confirmed space-occupying brain lesion including but not limited to the following:

o Brain abscess o Brain tumors o Arteriovenous malformations within the brain

Dementia or symptoms of dementia such as memory impairment or memory loss (including extrapyramidal disorders such as Parkinson's disease) that is associated with a new onset or progressive memory loss

and a decline in at least one of the following cognitive domains (DSM-5): o Complex attention

o Executive function o Learning and memory o Language o Perceptual-motor o Social cognition

Demyelinating disorders including multiple sclerosis Intellectual disability or intellectual developmental disorder when all of

the following are present: o The intellectual disability or intellectual developmental disorder is

associated with a known or suspected medical cause (e.g., traumatic brain injury, in utero toxin exposure, early seizure disorder, sickle cell disease, genetic disorders) and

o The intellectual disability or intellectual developmental disorder meets all of the following criteria (DSM-5): Deficits in intellectual function, such as reasoning, problem

solving, planning, abstract thinking, judgment, academic learning, and learning from experience, confirmed by both clinical assessment and individualized, standardized intelligence testing,

Deficits in adaptive functioning that result in failure to meet developmental and sociocultural standards for personal independence and social responsibility. Without ongoing support,




REVISED


(continued)

Sep. 1, 2017

Health Assessment, and BrainCare™ is unproven and not medically

necessary for diagnosing dementia or mild cognitive impairment”

o Modified language pertaining to clinical evidence/study findings for computerized neuropsychological testing to

indicate: The evidence is

insufficient to establish the validity and reliability of computerized tests to evaluate concussions

Prospective controlled trials are needed to

demonstrate the clinical utility of these tests to detect impairment following concussion

o Modified language pertaining

to clinical evidence/study findings for computerized cognitive testing indicating; removed language indicating no U.S. Food and Drug Administration (FDA) clearance was located in the

FDA database for Mindstreams® Cognitive Health Assessment or for BrainCare™

Updated supporting information to reflect the most current

description of services, clinical evidence, FDA information, and references

the adaptive deficits limit functioning in one or more activities of daily life, such as communication, social participation, and independent living across multiple environments, such as home,

school, work and community, and Onset of intellectual and adaptive deficits during the

developmental period

The scope of these criteria is applicable only to neuropsychological testing that is covered by the medical benefit. These criteria do not apply to evaluate or determine educational interventions.

Encephalopathy including acquired immunodeficiency syndrome (AIDS)

encephalopathy, human immunodeficiency virus (HIV) encephalopathy, hepatic encephalopathy, Lyme disease encephalopathy including neuroborreliosis, Wernicke's encephalopathy and systemic lupus erythematosus (SLE) encephalopathy.

Neurotoxin exposure with at least one of the following: o Demonstrated serum levels of neurotoxins

o Individual with documented significant prenatal alcohol, drug, or toxin exposure

Seizure disorder including patients with epilepsy and patients being considered for epilepsy surgery

Stroke Traumatic brain injury (TBI): TBI is defined as a bump, blow, or jolt to

the head or a penetrating head injury that disrupts the normal function

of the brain. (Centers for Disease Control and Prevention). See the following website for more information: http://www.cdc.gov/TraumaticBrainInjury/index.html. (Accessed May 30, 2017)

Baseline neuropsychological testing is unproven and not medically necessary in asymptomatic persons at risk for sport-related

concussions or brain injuries. There is insufficient evidence to indicate that the use of baseline neuropsychological testing in athletes or other individuals alters risk from concussion. There is insufficient evidence that baseline tests influence physician decision-making or outcomes of treatment of concussion.

Computerized neuropsychological testing is unproven and not medically necessary for evaluating concussions or brain injuries. The evidence is insufficient to establish the validity and reliability of

http://www.cdc.gov/TraumaticBrainInjury/index.html




REVISED


(continued)

Sep. 1, 2017 computerized tests to evaluate concussions. Prospective controlled trials are needed to demonstrate the clinical utility of these tests to detect impairment following concussion.

Neuropsychological testing is unproven and not medically necessary for the following diagnoses alone without other proven conditions as

noted above: Headaches including migraine headache History of myocardial infarction Intermittent explosive disorder

There is insufficient clinical evidence to demonstrate that the use of neuropsychological testing for patients with myocardial infarction, migraine or other headaches or intermittent explosive disorder without associated cognitive disorders can be used effectively for clinical decision making to improve patient management of those conditions.

Computerized cognitive testing including but not limited to

Cognivue®, Mindstreams® Cognitive Health Assessment, and BrainCare™ is unproven and not medically necessary for diagnosing dementia or mild cognitive impairment. Available clinical trials have failed to document a beneficial effect of computerized cognitive testing on long-term clinical outcomes. The evidence

is insufficient to establish the validity of computerized cognitive testing compared with traditional tests for the assessment of dementia and cognitive impairment.

Omnibus Codes

Oct. 1, 2017

Revised coverage guidelines for:

Chronic baroreceptor

stimulation of the carotid

sinus for treating hypertension, heart failure,

or other cardiovascular conditions (CPT codes 0266T, 0267T, 0268T, 0269T, 0270T, 0271T, 0272T, and 0273T) o Modified language pertaining

to U.S. Food and Drug Administration (FDA)

Refer to the policy for complete details on the coverage guidelines for Omnibus Codes.




REVISED

Omnibus Codes (continued)

Oct. 1, 2017

approval of the Barostim neo legacy device to indicate: In December 2014, the

FDA granted a unique and limited Humanitarian Device Exemption (HDE)

for use of the Barostim neo legacy device for treatment of hypertension

The HDE applies to U.S. clinical trial patients who were implanted with the Rheos Baroreflex Hypertension device, who achieved a

significant decrease in blood pressure during

their trial participation, and who now require a procedure to replace the device battery and/or repair the electrode lead

The FDA will allow the obsolete Rheos Baroreflex Hypertension device to be replaced by the current Barostim neo legacy device

The HDE does not apply

for treatment of heart failure

Implantable devices for

monitoring left atrial pressure (CPT code 0294T) o Updated list of applicable

CPT codes; revised description for 0294T

High dose rate electronic




REVISED


Oct. 1, 2017

brachytherapy (CPT codes 0394T and 0395T) o Updated list of applicable

CPT codes; removed 77424, 77425, and 77469

o Removed language

indicating: High dose rate electronic

brachytherapy is proven and medically necessary

for treating breast cancer

High dose rate electronic brachytherapy is unproven and not medically necessary for

treating nonmelanoma (i.e., basal cell or

squamous cell carcinomas) skin cancer

o Replaced language indicating: “High dose rate

electronic brachytherapy may be covered for treating certain facial nonmelanoma skin cancers when location can impact treatment outcomes” with “high

dose rate electronic brachytherapy may be covered for treating certain facial nonmelanoma skin cancers (i.e., basal cell

or squamous cell carcinomas) when location can impact




REVISED


Oct. 1, 2017

treatment outcomes” “High dose rate

electronic brachytherapy

is unproven and not medically necessary for treating all other

indications due to insufficient clinical evidence of safety and/or efficacy in

published peer-reviewed medical literature” with “high dose rate electronic brachytherapy is unproven and not medically necessary for

treating all indications due to insufficient clinical

evidence of safety and/or efficacy in published peer-reviewed medical literature”

Cooled radiofrequency

ablation (RFA) for the treatment of pain of any etiology (CPT codes 22899,

27299, 27599, and 64999) o Added language to indicate

the FDA has cleared, under 510(k) premarket

notifications, the Coolief RF probe for the management of osteoarthritis of the knee

in April 2017

Rhinophototherapy for treating allergies (CPT

30999) o Updated list of applicable

CPT codes; revised




REVISED


Oct. 1, 2017

description for 30999

Optical endomicroscopy (CPT

code 43252) o Updated list of applicable

CPT codes; removed 43206 and 88375

Videofluoroscopy, cineradiography, Spinalyzer and similar technology, and digital motion X-rays to

diagnose spinal and skeletal dysfunction (CPT codes 76120 and 76125) o Updated list of applicable

CPT codes; removed 76496 and 76499

Peripheral arterial disease rehabilitation/supervised

exercise therapy (SET) (CPT code 93668)

o Updated list of applicable CPT codes; revised description for 93668

o Replaced language indicating “peripheral arterial disease rehabilitation is unproven

and not medically necessary due to insufficient clinical evidence of safety and/or efficacy in published peer-

reviewed medical literature” with “peripheral arterial disease

rehabilitation/supervised exercise therapy (SET) is unproven and not medically necessary due to insufficient clinical evidence of safety and/or efficacy in published




REVISED


Oct. 1, 2017

peer-reviewed medical literature”

Hair analysis for evaluating

any disorder or condition (HCPCS code P2031) o Added language to indicate

hair analysis is unproven and not medically necessary for evaluating any disorder or condition due to insufficient clinical evidence of safety and/or efficacy in published peer-reviewed medical

literature o Removed language

indicating laboratory analysis of hair for content of environmental substances of

concern for exposure assessment and health

interpretation of the results is unproven and not medically necessary due to insufficient clinical evidence of safety and/or efficacy in published peer-reviewed

medical literature

Radiesse, Prolaryn, Prolaryn Plus, and Sculptra (HCPCS codes L8607, Q2026, and

Q2028) o Removed language

indicating Radiesse is proven and medically necessary and reconstructive for treating vocal fold insufficiency

o Added language to indicate Prolaryn and Prolaryn Plus (formerly the Radiesse




REVISED


Oct. 1, 2017

Laryngeal Implant) are proven and medically necessary and reconstructive

for treatment of vocal fold insufficiency

Dermal/skin substitutes

(HCPCS codes Q4100, Q4115, Q4123, Q4131-Q4143, and Q4145-Q4175) o Updated list of applicable

HCPCS codes; added Q4100 o Added language to indicate

AmnioFix®, Conexa™

Reconstructive Matrix, and CorMatrix® are unproven and not medically necessary for any indication due to insufficient clinical evidence

of safety and/or efficacy in published peer-reviewed

medical literature Added coverage guidelines for:

Three-dimensional (3-D)

printed cranial implants (HCPCS code L8699) o Added language to indicate

three-dimensional (3-D) printed cranial implants (e.g., OssDsign® Cranial Patient-Specific Implant,

OsteoFab™ Patient Specific Cranial Device) are unproven and not medically necessary due to insufficient clinical evidence of safety and/or efficacy in published peer-

reviewed medical literature

Intraoperative radiation therapy using low-energy x-




REVISED


Oct. 1, 2017

rays or electrons (CPT codes 77424, 77425, and 77469) o Added language to indicate

intraoperative radiation therapy, using low-energy x-rays or electrons, is

unproven and not medically necessary for treating all indications due to insufficient clinical evidence of safety

and/or efficacy in published peer-reviewed medical literature

Removed coverage guidelines for: o Radiostereometric analysis in

bone (CPT codes 0347T, 0348T, 0349T, and 0350T)

o Osteochondral autograft of the talus (CPT code 28446); refer to the Medical Policy titled Osteochondral Grafting for applicable coverage

guidelines o Serum proteomic profiling

using mass spectrometry (CPT codes 81538 and 84999)

o Red blood cell mechanical fragility testing (CPT code

85547) Updated supporting information

to reflect the most current clinical evidence and references

Proton Beam Radiation Therapy

Sep. 1, 2017

Revised coverage rationale: o Replaced language indicating

“proton beam radiation therapy is proven and

Proton beam radiation therapy is proven and medically necessary for definitive therapy of the following indications: Intracranial arteriovenous malformations (AVMs) Ocular tumors, including intraocular/uveal melanoma (includes the iris,




REVISED

Proton Beam Radiation Therapy (continued)

Sep. 1, 2017

medically necessary for treating the [listed] indications” with “proton

beam radiation therapy is proven and medically necessary for definitive

therapy of the [listed] indications”

o Updated list of indications for which proton beam radiation

therapy is unproven and not medically necessary for; added breast cancer

o Added language to indicate proton beam radiation therapy may be covered for

a diagnosis that is not listed as proven, including

recurrences or metastases in selected cases, when documentation is provided that sparing of the surrounding normal tissue

cannot be achieved with standard radiation therapy techniques, including intensity-modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT); requests for

these exceptions will be evaluated on a case-by-case basis

Added definition of “definitive therapy”


to reflect the most current clinical evidence and references

ciliary body and choroid) Skull-based tumors (e.g., chordomas, chondrosarcomas or paranasal

sinus tumors)

Proton beam radiation therapy is unproven and not medically necessary for treating ALL other indications, including but not limited to:

Age-related macular degeneration (AMD) Bladder cancer Brain and spinal cord tumors Breast cancer

Choroidal hemangioma Esophageal cancer Gynecologic cancers Head and neck cancers Hepatocellular carcinoma Lung cancer

Lymphomas Pancreatic cancer

Prostate cancer Vestibular tumors (e.g., acoustic neuroma or vestibular schwannoma) There is limited clinical evidence that directly compares proton beam therapy (PBT) with other types of radiation therapy. Current published evidence does

not allow for any definitive conclusions about the safety and efficacy of proton beam therapy to treat conditions other than those noted above as proven and medically necessary. Proton beam radiation therapy may be covered for a diagnosis that is not listed above as proven, including recurrences or metastases in selected cases, when documentation is provided that sparing of the

surrounding normal tissue cannot be achieved with standard radiation therapy techniques, including intensity-modulated radiation therapy (IMRT) and stereotactic body radiation therapy (SBRT). Requests for these exceptions will be evaluated on a case-by-case basis.

Proton beam radiation therapy used in conjunction with intensity-modulated radiation therapy (IMRT) is unproven and not medically necessary.




REVISED

Proton Beam Radiation Therapy (continued)

Sep. 1, 2017

Clinical evidence is insufficient to support the combined use of these technologies in a single treatment plan. Comparative effectiveness studies including randomized controlled trials are needed to demonstrate the safety

and long-term efficacy of combined therapy.




NEW

Brineura™ (Cerliponase Alfa)

Sep. 1, 2017

Brineura is proven and medically necessary for slowing the loss of ambulation in symptomatic pediatric patients with Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency when all of the following criteria are met:

I. For initial therapy, all of the following:

A. One of the following:

1. Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a neurologist with expertise in the diagnosis of CLN2

2. Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a physician in consultation with a neurologist with expertise in the diagnosis of CLN2

and B. Patient is age 3 years or older; and C. All of the following scores on the Clinical Scoring System for LINCL:

1. Combined score of 3 to 6 in the motor and language domains 2. Score of at least 1 in the motor domain 3. Score of at least 1 in the language domain

and D. One of the following:

1. Brineura is prescribed by a neurologist with expertise in the treatment of CLN2 2. Brineura is prescribed by a physician in consultation with a neurologist with expertise in the treatment of

CLN2 and

E. Brineura is to be administered intraventricularly by, or under the direction of, healthcare professionals

experienced in performing intraventricular infusions via an intracerebroventricular catheter; and F. Dosing is in accordance with the United States Food and Drug Administration approved labeling: 300 mg

administered once every other week as an intraventricular infusion; and G. Initial authorization will be for no more than 6 months.

II. For continuation therapy, all of the following:


1. Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a neurologist with expertise in the diagnosis of CLN2

2. Diagnosis of Late Infantile Neuronal Ceroid Lipofuscinosis type 2 (CLN2) by a physician in consultation with a neurologist with expertise in the diagnosis of CLN2

and B. Patient is age 3 years or older; and

C. Patient has a score of 1 or higher in the motor domain of the Clinical Scoring System for LINCL; and D. One of the following:

1. Brineura is prescribed by a neurologist with expertise in the treatment of CLN2




NEW

Brineura™ (Cerliponase Alfa) (continued)

Sep. 1, 2017 2. Brineura is prescribed by a physician in consultation with a neurologist with expertise in the treatment of CLN2

and

E. Brineura is to be administered intraventricularly by, or under the direction of, healthcare professionals experienced in performing intraventricular infusions via an intracerebroventricular catheter; and

F. Dosing is in accordance with the United States Food and Drug Administration approved labeling: 300 mg

administered once every other week as an intraventricular infusion; and G. Reauthorization will be for no more than 6 months.

Brineura (cerliponase alfa) is unproven and not medically necessary for other forms of Neuronal Ceroid Lipofuscinosis.

Radicava™ (Edaravone)

Sep. 1, 2017

Radicava (edaravone) is proven and medically necessary for the treatment of amyotrophic lateral sclerosis (ALS) in patients who meet all of the following criteria: I. For initial therapy, all of the following:

A. Submission of medical records (e.g., chart notes, previous medical history, diagnostic testing including:

imaging, nerve conduction studies, laboratory values) to support one of the following:

1. Diagnosis of “definite” or “probable” ALS per the revised EL Escorial and Airlie House diagnostic criteria, and prescribed by a neurologist with expertise in the diagnosis of ALS; or

2. Diagnosis of “definite” or “probable” ALS per the revised EL Escorial and Airlie House diagnostic criteria, and prescribed by a physician in consultation with a neurologist with expertise in the diagnosis of ALS;

and B. Submission of the most recent ALS Functional Rating Scale-Revised (ALSFRS-R) score confirming that the

patient has scores ≥ 2 in all items of the ALSFRS-R criteria at the start of treatment; and

C. Submission of medical records (e.g., chart notes, laboratory values) confirming that the patient has a % forced vital capacity (%FVC) ≥ 80% at the start of treatment; and

D. Radicava dosing for ALS is in accordance with the United States Food and Drug Administration approved labeling; and

E. Initial authorization will be for no more than 6 cycles (64 doses over 168 days).

II. For continuation therapy, all of the following:

A. One of the following: 1. Diagnosis of “definite” or “probable” ALS per the revised EL Escorial and Airlie House diagnostic criteria,

and prescribed by a neurologist with expertise in the diagnosis of ALS; or 2. Diagnosis of “definite” or “probable” ALS per the revised EL Escorial and Airlie House diagnostic criteria,

and prescribed by a physician in consultation with a neurologist with expertise in the diagnosis of ALS;

and B. Patient is currently receiving Radicava therapy; and

http://www.outcomes-umassmed.org/als/alsscale.aspx




NEW

Radicava™ (Edaravone) (continued)

Sep. 1, 2017 C. Patient is not dependent on invasive ventilation or tracheostomy; and D. Radicava dosing for ALS is in accordance with the United States Food and Drug Administration approved

labeling; and

E. Authorization will be for no more than 6 cycles (60 doses over 168 days).

White Blood Cell

Colony Stimulating Factors

Sep. 1, 2017

The policy refers to the following drug products: White Blood Cell Colony Stimulating Factors (CSFs):

Granix Leukine Neulasta

Neupogen Zarxio For the coverage criteria below, in absence of specified drug products, the term “colony stimulating factors” or “CSFs” will be used in this policy where the coverage criteria apply to all products listed above.

I. Bone marrow/stem cell transplant (Leukine, Neupogen, Zarxio) Leukine, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are

met:

A. One of the following: 1. Patient has non-myeloid malignancies and is undergoing myeloablative chemotherapy followed by

autologous or allogeneic bone marrow transplant (BMT); or 2. Used for mobilization of hematopoietic progenitor cells into the peripheral blood for collection by

leukapheresis; or 3. Patient has had a peripheral stem cell transplant (PSCT) and have received myeloablative

chemotherapy; and

B. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and

C. Prescribed by or in consultation with a hematologist or oncologist.

II. Acute myeloid leukemia (AML) induction or consolidation therapy (Leukine, Neupogen, Zarxio)

Leukine, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are

met:

A. Diagnosis of AML; and B. Patient has completed either induction or consolidation chemotherapy; and C. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and D. Prescribed by or in consultation with a hematologist or oncologist.

III. Neutropenia associated with cancer chemotherapy – dose dense chemotherapy (Leukine, Neulasta,




NEW

White Blood Cell Colony Stimulating Factors

(continued)

Sep. 1, 2017

Neupogen, Zarxio) Leukine, Neulasta, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:

A. One of the following: 1. Patient is receiving National Cancer Institute’s Breast Intergroup, INT C9741 dose dense chemotherapy

protocol for primary breast cancer; or

2. Patient is receiving a dose-dense chemotherapy regimen for which the incidence of febrile neutropenia (FN) is unknown;

and B. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and C. Prescribed by or in consultation with a hematologist or oncologist.

IV. Primary prophylaxis of chemotherapy-induced febrile neutropenia (FN) (Granix, Leukine, Neulasta, Neupogen, Zarxio) White blood cell colony stimulating factors are proven and medically necessary when all of the following criteria are met:


1. Patient is receiving chemotherapy regimen(s) associated with > 20% incidence of FN; or 2. Both of the following:

a. Patient is receiving chemotherapy regimen(s) associated with 10-20% incidence of FN; and b. Patient has one or more risk factors associated with chemotherapy-induced infection, FN, or

neutropenia (see the list of risk factors in the Clinical Evidence section of the policy); and

B. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and C. Prescribed by or in consultation with a hematologist or oncologist.

V. Secondary prophylaxis of febrile neutropenia (FN) (Granix, Leukine, Neulasta, Neupogen, Zarxio) White blood cell colony stimulating factors are proven and medically necessary when all of the following criteria are met:

A. Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (ANC ≤ 500 cells/mm3); and

B. Patient has a history of FN during a previous course of chemotherapy; and C. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and D. Prescribed by or in consultation with a hematologist or oncologist.

VI. Treatment of Febrile Neutropenia (Leukine, Neulasta, Neupogen, Zarxio) [off-label] Leukine, Neulasta, Neupogen and Zarxio are proven and medically necessary when all of the following




NEW


(continued)

Sep. 1, 2017

criteria are met:

A. Patient is receiving myelosuppressive anticancer drugs associated with neutropenia (ANC ≤ 500 cells/mm3);

and B. Diagnosis of FN and patient is considered high risk for infection-associated complications; and C. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling;

and

D. Prescribed by or in consultation with a hematologist or oncologist.

VII. Severe Chronic Neutropenia (SCN) (Neupogen, Zarxio)

Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:

A. Diagnosis of SCN (i.e., congenital, cyclic, and idiopathic neutropenias with chronic ANC ≤ 500 cells/mm3) B. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling C. Prescribed by or in consultation with a hematologist or oncologist

VIII. HIV-related neutropenia (Leukine, Neupogen, Zarxio) [off-label] Leukine, Neupogen and Zarxio are proven and medically necessary when all of the following criteria are met:

A. Diagnosis of HIV infection; and B. Patient has an ANC ≤ 1,000 (cells/mm3); and

C. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and

D. Prescribed by or in consultation with a hematologist, oncologist or infectious disease specialist.

IX. Hepatitis-C treatment related neutropenia (Neupogen) [off-label] Neupogen is proven and medically necessary when all of the following criteria are met:

A. One of the following: 1. All of the following:

a. Diagnosis of Hepatitis C virus; and b. Patient is undergoing treatment with Peg-Intron (peginterferon alfa-2b) or Pegasys (peginterferon

alfa-2a); and c. Documentation of neutropenia (ANC ≤ 500 cells/mm3) after dose reduction of Peg-Intron or Pegasys;

or 2. Both of the following:

a. Documentation of interferon-induced neutropenia (ANC ≤ 500 cells/mm3) due to treatment with Peg-

Intron (peginterferon alfa-2b) or Pegasys (peginterferon alfa-2a); and b. One of the following:

i. Diagnosis of HIV co-infection; or ii. Status post liver transplant; or

iii. Diagnosis of established cirrhosis and




NEW


(continued)

Sep. 1, 2017 B. Medication is dosed in accordance with the United States Food and Drug Administration approved labeling; and

C. Prescribed by or in consultation with a hematologist or oncologist.


REVISED

Clotting Factors and Coagulant Blood Products

Sep. 1, 2017

Revised coverage rationale for Hemophilia A (i.e., Factor VIII Deficiency, Classical Hemophilia): o Reformatted coverage

criteria for Antihemophilic Factor (recombinant) [Advate or Recombinate] for clarity

o Modified coverage criteria for Antihemophilic Factor

(recombinant) [Xyntha]: Removed criterion

requiring use in treatment of bleeding episodes or prevention of bleeding in surgical interventions or invasive

procedures (e.g., surgical prophylaxis)

Added criterion requiring physician attestation that patient would

preferentially benefit from Xyntha based on

one of the following: - Patient is at high risk

for the development of inhibitors (e.g., family history of inhibitors and

success with

Refer to the policy for complete details on the coverage guidelines for Clotting Factors and Coagulant Blood Products.




REVISED

Clotting Factors and Coagulant Blood Products

(continued)

Sep. 1, 2017 product, current treatment less than 50 days, high risk

genetic mutation, history of initial intensive therapy

greater than 5 days) - Patient has

developed inhibitors - Patient has

undergone immune tolerance induction/immune tolerance therapy

Infliximab (Remicade®, Inflectra™,

Renflexis™)

Sep. 1, 2017

Changed policy title; previously titled Infliximab (Remicade® and Inflectra™)

Revised coverage rationale: o Updated list of infliximab

products addressed in the policy; added Renflexis™

(infliximab-abda) o Added coverage guidelines

for Renflexis™ (infliximab-abda) to indicate: Coverage will be

provided contingent on the criteria listed in the

Preferred Product section

of the policy and the coverage criteria listed in the Diagnosis-Specific Criteria section of the policy

In order to continue coverage, members already on Renflexis™ will be required to

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

Renflexis™ (infliximab-abda) I. Preferred Product

Medical Necessity Plans

Remicade® (infliximab) is the preferred infliximab product. Coverage will be provided for Remicade® contingent on the coverage criteria in section II.

Coverage for Inflectra™ (infliximab-dyyb) or Renflexis™ (infliximab-abda) will be provided contingent on the criteria in this section and the coverage criteria in section B. In order to continue coverage, members

already on Inflectra™ or Renflexis™ will be required to change therapy to

Remicade® unless they meet the criteria in this section.

Preferred Product Criteria

Treatment with Inflectra™ (infliximab-dyyb), Renflexis™ (infliximab-

abda) or other infliximab biosimilar is medically necessary for the indications specified in this policy when both the following criteria are met: A. One of the following:

1. Both of the following:




REVISED


Renflexis™) (continued)

Sep. 1, 2017

change therapy to Remicade® unless they meet the criteria in the

Preferred Product section of the policy

Treatment with

Renflexis™ (infliximab-abda) is medically necessary for the indications specified in

this policy when the listed criteria are met

Updated list of applicable HCPCS codes: o Revised description for

Q5102; added duplicate

entry without modifier to denote drug manufacturer

“Merck” Updated supporting information

to reflect the most current FDA and CMS information and references

o Replaced reference to “MCG® Ambulatory Care 19th Edition” with “MCG™ Care Guidelines, Ambulatory Care, 21st Edition”

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

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

Remicade. or

2. Both of the following: a. History of intolerance or adverse event to Remicade.

b. Physician attests that. in their clinical opinion. the same intolerance or adverse event would not be expected to occur with Inflectra or other infliximab biosimilar product.

and B. Both of the following:

1. Patient has not had a loss of a favorable response after

established maintenance therapy with Remicade or other infliximab biosimilar product.

2. Patient has not developed neutralizing antibodies to any infliximab biosimilar product that has lead to an attenuation of efficacy of therapy.61

Non-Medical Necessity Plans

Any infliximab product is to be approved contingent on the coverage criteria in section II.

II. Diagnosis-Specific Criteria

“Infliximab” will be used to refer to all infliximab products.

Infliximab is proven and medically necessary for the treatment of:

A. Ankylosing spondylitis when the following criterion is met:

1. Diagnosis of ankylosing spondylitis (AS)

B. Crohn’s disease when one of the following criteria is met:

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

2. Both of the following: a. Diagnosis of moderately to severely active Crohn’s disease;

and




REVISED



Sep. 1, 2017

b. History of failure, contraindication, or intolerance to at least one conventional therapy (e.g., corticosteroids, 6-mercaptopurine, azathioprine, methotrexate, etc.)

C. Noninfectious uveitis when both of the following criteria are met:

1. 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

2. History of failure, contraindication, or intolerance to all of the following:

a. Topical corticosteroids b. Systemic corticosteroids c. Immunosuppressive drugs (e.g., azathioprine, cyclosporine,

or methotrexate)

D. Plaque psoriasis when both of the following criteria are met:

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

2. Patient is a candidate for systemic therapy

E. Psoriatic arthritis when the following criterion is met:1,57,62 1. Diagnosis of psoriatic arthritis (PsA)

F. Rheumatoid arthritis when both of the following criteria are met: 1. Diagnosis of moderately to severely active rheumatoid arthritis

(RA); and 2. One of the following:

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

G. Sarcoidosis when all of the following criteria are met: 1. Diagnosis of sarcoidosis; and 2. History of failure, contraindication, or intolerance to

corticosteroids (e.g., prednisone, methylprednisolone); and 3. History of failure, contraindication, or intolerance to one

immunosuppressant (e.g., methotrexate, cyclophosphamide,

azathioprine)

H. Ulcerative colitis when both of the following criteria are met:




REVISED



Sep. 1, 2017 1. Diagnosis of moderately to severely active ulcerative colitis (UC); and

2. History of failure, contraindication, or intolerance to at least one

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

There may be other conditions that qualify as serious, rare diseases for which the use of infliximab may be appropriate. Please 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 Sjogren’s syndrome Graft-vs-host disease Myelodysplastic syndromes Undifferentiated spondyloarthropathy Reiter’s syndrome

Hidradenitis suppurativa

Wegener’s granulomatosis Juvenile idiopathic arthritis (juvenile rheumatoid arthritis) 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.

Repository Corticotropin Injection (H.P.

Acthar Gel®)

Sep. 1, 2017

Changed policy type classification from “Drug Policy” to “Medical Benefit Drug Policy”

to clarify policy guidelines apply to drug coverage provided under the medical benefit

Revised coverage rationale: o Modified coverage criteria for

treatment of infantile spasm; added criterion

requiring physician attestation that there is no

H.P. Acthar Gel (repository corticotropin injection) is proven and medically necessary for the treatment of:

I. Infantile spasm (i.e., West Syndrome) for up to 4 weeks when all of the following criteria are met: A. Diagnosis of infantile spasms (i.e., West Syndrome); and B. Patient is less than 2 years old; and C. Physician attestation that there is no competent caregiver to

administer the drug; physician must submit explanation; and D. H.P. Acthar Gel dosing for infantile spasm is as follows:

1. Initial dose: 75 U/m2 intramuscular (IM) twice daily for 2 weeks. 2. After 2 weeks, dose should be tapered according to the following




REVISED

Repository Corticotropin Injection (H.P.

Acthar Gel®) (continued)

Sep. 1, 2017 competent caregiver to administer the drug (physician must submit

explanation) o Added coverage criteria for

treatment of Opsoclonus-

myoclonus syndrome (i.e., OMS, Kinsbourne Syndrome) to indicate H.P. Acthar Gel (repository corticotropin

injection) is proven and medically necessary when both of the following criteria are met: Diagnosis of Opsoclonus-

myoclonus syndrome

(i.e., OMS, Kinsbourne Syndrome); and

Physician attestation that there is no competent caregiver to administer the drug (physician must submit explanation)

Updated supporting information to reflect the most current clinical evidence and references

schedule: 30 U/m2 IM in the morning for 3 days; 15 U/m2 IM in the morning for 3 days; 10 U/m2 IM in the morning for 3 days; and 10 U/m2 IM every other morning for 6 days (3 doses).

II. Opsoclonus-myoclonus syndrome (i.e., OMS, Kinsbourne Syndrome)

when both of the following criteria are met:

A. Diagnosis of Opsoclonus-myoclonus syndrome (i.e., OMS, Kinsbourne Syndrome); and

B. Physician attestation that there is no competent caregiver to administer the drug. Physician must submit explanation.

III. H.P. Acthar Gel is not medically necessary for treatment of acute

exacerbations of multiple sclerosis. For non-medical necessity plans, H.P. Acthar Gel may be covered for the treatment of acute exacerbation of multiple sclerosis (MS)

Although FDA labeling suggests that H.P. Acthar may be used in the following conditions, it is not FDA indicated.

H.P. Acthar Gel is unproven and not medically necessary for treatment of the following disorders and diseases: Rheumatic Disorders: psoriatic arthritis, rheumatoid arthritis, including

juvenile rheumatoid arthritis, ankylosing spondylitis Collagen Diseases: systemic lupus erythematosus, systemic

dermatomyositis (polymyositis) Dermatologic Diseases: Severe erythema multiforme, Stevens-Johnson

syndrome Allergic States: Serum sickness Ophthalmic Diseases: Severe acute and chronic allergic and

inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic

neuritis, chorioretinitis, anterior segment inflammation Respiratory Diseases: Symptomatic sarcoidosis Edematous State: To induce a diuresis or a remission of proteinuria in

the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus

Any indication outside of the proven indications above




UPDATED

Home Health Care

Sep. 1, 2017

Updated coverage rationale/coverage limitations and exclusions; added language

to indicate exceptions for intermittent care may be made in certain circumstances when

the need for more care is finite and predictable (also addressed in definition of “intermittent care”)

Updated definition of: o Custodial care o Intermittent care o Skilled care

Updated list of applicable HCPCS codes; revised description for

S9214, S9338, S9366, and S9372

Indications for Coverage

The services being requested must meet all of the following: Be ordered and directed by a treating practitioner or specialist (M.D.,

D.O., P.A. or N.P); and The care must be delivered or supervised by a licensed professional in

order to obtain a specified medical outcome; and

Services must be of Skilled Care in nature (refer to the Coverage Determination Guideline titled Skilled Care and Custodial Care Services and the Definitions section); and

Services must be intermittent and part time (typically provided for less than 4 hours per day; refer to the member specific benefit plan document for intermittent definitions, if provided); and

Services are provided in the home in lieu of Skilled Care in another setting (such as but not limited to a nursing facility, acute inpatient rehabilitation or a hospital); and

Services must be clinically appropriate and not more costly than an alternative health services; and

A written treatment plan must be submitted with the request for specific

services and supplies. Periodic review of the written treatment plan may

be required for continued Skilled Care needs and progress toward goals; and

Services are not provided for the comfort and convenience of the member or the member’s family; and

Services are not Custodial Care in nature. Medical Necessity Plans

Use the criteria above where applicable.

Additional Information

Medical supplies and medications that are used in conjunction with a

home health care visit are covered as part of that visit. Some examples are, but not limited to, surgical dressing, catheters, syringes, irrigation devices. Reimbursement for home health care visits and supplies are contractually determined.

Eligible physical, occupational and speech therapy received in the home from a Home Health Agency is covered under the Home Health Care

section of the COC. The Home Health Care section only applies to services that are rendered by a Home Health Agency.

Eligible physical, occupational and speech therapy received in the home




UPDATED

Home Health Care (continued)

Sep. 1, 2017 from an independent physical, occupational or speech therapist (a therapist that is not affiliated with a Home Health Agency) is covered under the Rehabilitation Services-Outpatient Therapy section of the COC.

Coverage Limitations and Exclusions

Home health care does not include custodial care, domiciliary care,

private duty nursing, respite care, or rest cures and therefore these services are not covered (check the member specific benefit plan document).

Services of personal care attendants (these are not home health aides). We will determine if benefits are available by reviewing both the skilled nature of the

service and the need for Physician-directed medical management. A service will not be determined to be "skilled" simply because there is not an available caregiver.

Covered pharmaceuticals, drugs, and DME provided in connection with home health services may be subject to separate benefit categories. Please reference the Durable Medical Equipment and the Pharmaceutical

Products benefit sections of the member specific benefit plan document. Homemaker services such as home meal delivery services (e.g., Meals-

on-Wheels) or transportation services (e.g., Dial-a-Ride) are excluded. Private Duty Nursing (refer to the Coverage Determination Guideline

titled Private Duty Nursing Services (PDN)). Services of an independent nurse hired directly by the family/patient are

excluded.

Home health services beyond benefit limits, e.g., visits. For intermittent care, exceptions may be made in certain circumstances

when the need for more care is finite and predictable.

Skilled Care and Custodial Care

Services

Sep. 1, 2017

Updated definition of: o Custodial care

o Skilled care

Updated list of applicable HCPCS codes; added T1019 and T1020


Skilled Care in the member’s place of residence (see Definitions section). Skilled Care includes:

o Skilled nursing

o Skilled teaching o Skilled rehabilitation (physical therapy, occupational therapy and

speech therapy) For Skilled Care to be covered in the member’s place of residence, the

following criteria must be met:

o Be ordered and directed by a licensed practitioner or specialist (M.D., D.O., P.A. or N.P).




UPDATED

Skilled Care and Custodial Care Services

(continued)

Sep. 1, 2017 o A plan of care must be established and periodically reviewed and updated by the treating practitioner or specialist.

o The care must be delivered or supervised by a licensed nurse,

technical or professional medical personnel in order to obtain a specified medical outcome.

o It must not be Custodial Care (see Definitions section).

o The care requires clinical training in order to be delivered safely and effectively.

o The patient’s condition must be documented to be such that they cannot receive the skilled care in a setting other than the member’s

place of residence. Coverage Limitations and Exclusions

Skilled Care does not include Custodial Care (see Definitions section), including but not limited to; domiciliary care, respite care, or rest cures.

Services provided by personal care attendants, family members or nonprofessional caregivers.

A service is not skilled care simply because there is not an available

caregiver.

Homemaker services unrelated to the member's care or home meal delivery services (e.g., Meals-on-Wheels) or transportation services (e.g., Dial-a-Ride).

Private Duty Nursing (check the member specific benefit plan document) Home Health Services beyond benefit limits (e.g., visits). Services provided as part of another benefit.


REVISED

Durable Medical

Equipment, Orthotics, Ostomy

Supplies, Medical Supplies and Repairs/ Replacements

Oct. 1, 2017 Revised coverage

rationale/indications for coverage; added language to

indicate lymphedema stockings for the arm are covered on an unlimited basis as to number of items and dollar amounts covered as required by the Women’s Health and Cancer Rights Act (WHCRA) of 1998

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

Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements.




REVISED

Preventive Care Services

Oct. 1, 2017

Updated coverage rationale/indications for coverage:

Pediatrics o Clarified list of services

covered under the

preventive care benefit for children (of the appropriate age); replaced “counseling for fluoride for prevention of dental cavities” with “application of fluoride by a

primary care provider for prevention of dental cavities”

Revised list of applicable procedure and diagnosis codes for:

Preventive Care Services

Colorectal Cancer Screening

o Updated list of applicable procedure codes for fecal occult blood testing (FOBT), fecal immunochemical test (FIT), fecal DNA, sigmoidoscopy, or

colonoscopy: Modified Code Group 5

for pre-op/consultation; removed CPT codes 99241, 99242, 99243,

99244, and 99245

Preeclampsia Screening (new to

policy) o Added language to indicate:

The USPSTF recommends screening

for preeclampsia in pregnant women with blood pressure

Refer to the policy for complete details on the coverage guidelines for Preventive Care Services.




REVISED

Preventive Care Services (continued)

Oct. 1, 2017 measurements throughout pregnancy (USPSTF Rating: B)

Preeclampsia screening by blood pressure measurement is included

in the code for a wellness examination visit; see section titled Wellness Examinations

for applicable procedure codes

See section titled Wellness Examinations for applicable preventive benefit instructions

Expanded Women’s Preventive Health

Breastfeeding Support, Supplies,

and Counseling o Updated list of applicable

procedure codes for support and counseling; removed

CPT codes 99241, 99242, 99243, 99244, and 99245

Prosthetic Devices, Wigs, Specialized, Microprocessor or

Myoelectric Limbs

Oct. 1, 2017

Revised coverage rationale for:

Prosthetic Devices and Wigs

o Removed language pertaining to lymphedema

stockings for the arm; added reference link to Coverage

Determination Guideline titled Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/ Replacements for applicable coverage guidelines


Prosthetic Devices and Wigs

A determination of coverage for the prosthesis is based on the member’s potential functional abilities. Potential functional ability is based on the

reasonable expectations of the prosthetist, and treating physician, considering factors including, but not limited to: o The member’s past history (including prior prosthetic use if

applicable); and o The member’s current condition including the status of the residual

limb and the nature of other medical problems. Prosthetic device coverage is limited to those prosthetic devices that

replace a limb or external body part that are listed below: o Artificial arms, legs, feet and hands.




REVISED


Myoelectric Limbs (continued)

Oct. 1, 2017

o Removed language pertaining to speech aid prosthetics and

tracheoesophageal voice prosthesis

Specialized, Microprocessor

or Myoelectric Limbs o Updated coverage criteria for

computerized and specialized lower limb prostheses; added functional level classification of: 2 or above for HCPCS

code L5972 (microprocessor or specialized foot/feet)

3 or above for HCPCS code L5961 (hips)

o Updated coverage criteria for myoelectric upper limbs

(arms, joints and hands); added criterion requiring the specific need for a technologic or design feature to be documented in the medical record

Updated and reformatted lists of applicable CDT/HCPCS codes: o Transferred content to

embedded Excel file format

o Removed D5952, D5953, D5960, L5781, L5782, L8500, L8507, L8509,

S8420, S8421, S8422, S8423, S8424, S8425, S8426, S8427, S8428, and S8429

o Revised description for L5972, L6000, L6010,

o Artificial eyes, ears and nose. o Benefits include breast prosthesis and mastectomy bras. These items

are always covered on an unlimited basis as to number of items and

dollar amounts covered as required by the Women’s Health and Cancer Act of 1998.

Note: For lymphedema stockings for the arm, refer to the Coverage

Determination Guideline titled Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements.

Prosthetic devices when covered, regardless of the setting or vendor from whom the prosthetic device is dispensed, are covered under the Prosthetic Devices section of the benefit document.

Prosthetic devices must be ordered by or under the direction of a

physician. Manufactured prosthetic devices must be approved by the Food and Drug

Administration (FDA) and otherwise generally considered to be safe and effective for the purposes intended and the item must be reasonable and necessary for the individual member.

Implantable devices/prostheses, such as artificial heart valves, are not

prosthetics. If covered, these devices would be covered as a surgical

service. Coverage is available for repair and replacement, when it is not due to

theft, loss, misuse, malicious damage or gross neglect. Several states mandate coverage for prosthetics. Please check the

member specific benefit document for coverage. Specialized, Microprocessor or Myoelectric Limbs

Computerized, bionic, microprocessor or myoelectric terms are considered

the same for the purpose of this policy. Some states may require coverage of prosthetics that UnitedHealthcare may not otherwise consider covered.

Lower Extremity Specialized, computerized or microprocessor limbs are based on a member’s current functional capabilities and his/her expected functional rehabilitation potential. If more than one prosthetic limb meets a member’s prosthetic rehabilitation needs, the least costly prosthetic will be approved.

Evidence is insufficient to permit conclusions regarding the effect of a microprocessor-controlled prosthesis on health outcomes in limited community ambulators (K2). Evidence is also insufficient to permit

conclusions regarding the effect of a next-generation microprocessor-




REVISED



Oct. 1, 2017

L6696, L6697, and L8015 Updated supporting information

to reflect the most current

references

controlled prosthesis on health outcomes. Therefore, these are considered investigational and not covered.

Prosthetic limbs are a covered health service when criteria are met: Ordered by a physician; and Member is evaluated for his/her individual needs by a healthcare

professional with the qualifications and training and under the supervision of the ordering physician to make an evaluation (documentation should accompany the order); and

Ordering physician signs the final prosthetic proposal; and

The records must document the member’s current functional capabilities and his/her expected functional rehabilitation potential, including an explanation for the difference, if that is the case. (It is recognized within the functional classification hierarchy that bilateral amputees often cannot be strictly bound by functional level classifications); and

Prosthetic replaces all or part of a missing limb; and

Prosthetic will help the member regain or maintain function; and Member is willing and able to participate in the training for the use of the

prosthetic (especially important in use of a computerized upper limb); and

Member is able to physically function at a level necessary for a computerized prosthetic or microprocessor, e.g., hand, leg or foot.

Coverage of computerized and specialized lower limb prostheses is based on maximum prosthetic function level of the member (see Lower Limb Rehabilitation Classification Levels 1-4 in the Definitions section of the policy). Member meets criteria for prosthetic limbs above; and Member has or is able to gain Lower Limb Rehabilitation Classification

Levels 2 - 4 for prosthetic ambulation (see Definitions section of the

policy).

HCPCS Code Description

Microprocessor or Specialized Foot or Feet

Note: A user adjustable heel height feature (L5990) will be denied as not meeting criteria for coverage.

L5972 Functional level is 2 or above





REVISED



Oct. 1, 2017







Knees

Note: Basic lower extremity prostheses include a single axis, constant friction knee. Other prosthetic knees are indicated based upon functional classification.

L5930 Functional level is 4























REVISED



Oct. 1, 2017

L5859

Meets ALL of the criteria below:

Has a microprocessor (swing and stance phase type

(L5856)) controlled (electronic) knee K3 functional level only Weight greater than 110 lbs. and less than 275 lbs. Has a documented comorbidity of the spine and/or

sound limb affecting hip extension and/or quadriceps function that impairs K-3 level function with the use of a microprocessor-controlled knee alone

Is able to make use of a product that requires daily charging

Is able to understand and respond to error alerts and alarms indicating problems with the function of the unit

Ankles

L5982 Lower limb rehabilitation classification is 2 or above




Hips


Sockets

Note:

Exception: A test socket is not indicated for an immediate prosthesis (L5400-L5460).

Socket replacements are indicated if there is adequate documentation of functional and/or physiological need. It is recognized that there are

situations where the explanation includes but is not limited to: o Changes in the residual limb; o Functional need changes;

o Or irreparable damage or wear/tear due to excessive member weight or prosthetic demands of very active amputees.

L5618

More than 2 test (diagnostic) sockets for an individual

prosthesis are not indicated unless there is documentation in the medical record which justifies the need




REVISED



Oct. 1, 2017

L5620



L5622


prosthesis are not indicated unless there is

documentation in the medical record which justifies the need

L5624

More than 2 test (diagnostic) sockets for an individual prosthesis are not indicated unless there is

documentation in the medical record which justifies the need

L5626

More than 2 test (diagnostic) sockets for an individual prosthesis are not indicated unless there is documentation in the medical record which justifies the need

L5628



L5654 No more than two of the same socket inserts are allowed per individual prosthesis at the same time







L5679 No more than two of the same socket inserts are




REVISED



Oct. 1, 2017

allowed per individual prosthesis at the same time



Myoelectric Upper Limbs (arms, joints and hands) are covered when criteria are met: Member meets all the criteria for prosthetic limbs above; and

Member has a congenital missing or dysfunctional arm and/or hand; or Member has a traumatic or surgical amputation of the arm (above or

below the elbow); and The remaining musculature of the arm(s) contains the minimum

microvolt threshold to allow operation of a myoelectric prosthetic device (usually 3-5 muscle groups must be activated to use a computerized

arm/hand), no external switch; and A standard passive or body-powered prosthetic device cannot be used or

is insufficient to meet the functional needs of the individual in performing activities of daily living (ADL’s); and

The medical records must indicate the specific need for the technologic or design features.

Coverage Limitations and Exclusions

Coverage for wigs/scalp hair prosthesis is excluded unless specifically

listed as a covered health service. Some states mandate coverage. Check the member specific benefit document for coverage. When wigs are covered, the benefit does not include coverage for hair implants or hair plugs.

Coverage is not available for prosthetics if the member is eligible through

a governmental program for a prosthetic due to military service related injuries and/or primary insurance coverage, e.g., VA, Medicare or

TriCare. Replacement of prosthetic devices due to misuse, malicious damage or

gross neglect or to replace lost or stolen items. (Check member specific benefit document.)

Repairs to prosthetic devices due to misuse, malicious damage or gross neglect. (Check member specific benefit document.)

If more than one prosthetic device can meet the member’s functional




REVISED



Oct. 1, 2017

needs, benefits are only available for the prosthetic device that meets the minimum specifications for the member’s needs.

Coverage beyond any dollar or frequency limits specified in the member’s

specific benefit documents.



Policy Title Effective Date Summary of Changes Utilization Management Guiding Principles

REVISED

Office Based Program

Oct. 1, 2017

Updated list of related policies; added reference link to Medical Policy titled Surgical and Ablative

Procedures for Venous Insufficiency and Varicose Veins

Revised list of applicable CPT

codes for elective procedures requiring prior authorization if not performed in the office setting; added:

Dermatology o 10120, 10140, 11400,

11401, 11404, 11420, 11421, 11423, 11424, 11426, 11442, and 11606

Gastroenterology

o 45300, 45330, and 46922 General Surgery

o 19000 Muscular/Skeletal o 64520 Obstetrics & Gynecology o 57460

Urology o 55250 Vascular o 36473, 36475, and 36478

Introduction

In an effort to minimize out-of-pocket costs for UnitedHealthCare members and to improve cost efficiencies for the overall health care system, we are implementing prior authorization guidelines that aim to encourage more cost-effective sites of service for certain outpatient surgical procedures, when

medically appropriate.

These prior authorization requirements apply to UnitedHealthcare commercial plans that require services to be medically necessary, including being cost-effective. Refer to the member specific benefit plan document to determine if medical necessity applies.

Specific procedure codes for services can be found on the Prior Authorization List (refer to the References section of the policy). Coverage Rationale

With the exception of the qualifying conditions below, certain elective procedures should be performed in an office setting.

The following will be taken into account to determine whether the elective procedure is being performed in a cost-effective setting:

Members benefit plan Geographic availability of an in-network provider Office capability (i.e., appropriate equipment) Significant member comorbidities (see list of examples of Qualifying

Conditions below) Certain Qualifying Conditions

Some patients may require more complex care due to certain medical factors or functional limitations and it may be appropriate to have the procedure in

an outpatient hospital setting or ambulatory surgery center (not an all-inclusive list): Patient unable to cooperate with procedure due to mental status, severe

anxiety, or extreme pain sensitivity Failed office based procedure attempt due to body habitus, abnormal

anatomy, or technical difficulties

Bleeding disorder that would cause a significant risk of morbidity Allergy to local anesthetic




REVISED

Office Based Program (continued)

Oct. 1, 2017 Potential Documentation Requirements

Physician office notes Elective Procedures List

Prior authorization is required for the following procedures if not performed in an office setting (see Applicable Codes table).

Specialty Medication Administration – Site of Care Review Guidelines

Sep. 1, 2017

Updated list of related policies; added reference link to Medical Benefit Drug Policy titled Radicava™ (Edaravone)

Revised coverage rationale: o Updated list of specialty

medications requiring healthcare provider administration; added edaravone (Radicava™)

Introduction

This guideline addresses the criteria for consideration of allowing hospital

outpatient facility specialty medication infusion services. This includes claim submission for hospital based services with the following CMS/AMA Place of Service codes: 22 On Campus-Outpatient Hospital, and 19 Off Campus-Outpatient Hospital.

Alternative sites of care, such as non-hospital outpatient infusion, physician office, ambulatory infusion or home infusion services are well accepted places of service for medication infusion therapy. If a patient does not meet

criteria for outpatient hospital facility infusion, alternative sites of care may be used. This policy applies to these specialty medications that require healthcare

provider administration: Abatacept (Orencia®) Eculizumab (Soliris®) Edaravone (Radicava™) Eteplirsen (Exondys 51™) Golimumab (Simponi® Aria™) Infliximab (Remicade®)

Infliximab-abda (Renflexis™)

Infliximab-dyyb (Inflectra™) Tocilizumab (Actemra®) Vedolizumab (Entyvio®) Review Criteria for Site of Care Selection

Outpatient hospital facility-based intravenous medication infusion is medically necessary for persons who meet any of the following

criteria (submission of medical records is required, detailing at least




REVISED

Specialty Medication Administration –

Site of Care Review Guidelines (continued)

Sep. 1, 2017

ONE of the following): Medically unstable based upon submitted clinical history; or Initial medication infusion of or re-initiation after more than 6 months

following discontinuation of therapy; or Previous experience of a severe adverse event following infusion.

Examples include but are not limited to anaphylaxis, seizure,

thromboembolism, myocardial infarction, renal failure; or Continuing experience of adverse events that cannot be mitigated by pre-medications or infusion rate adjustments; or

Physically and/or cognitively impaired AND no home caregiver available;

or Difficulty establishing and maintaining patent vascular access; or Homecare or infusion provider has deemed that the patient, home

caregiver, or home environment is not suitable for home infusion therapy.

Additional Information

Medical necessity criteria for administration of intravenous infusion therapy

at home are addressed in MCG™ Care Guidelines, 21st edition, 2017, Home

Infusion Therapy, CMT: CMT-0009(SR). Benefit Considerations

This guideline applies to members with 2011 COC or Summary Plan Document with benefits available for health care services if medically necessary and have been approved for the requested medication clinical use. This guideline applies to UnitedHealthcare Commercial plans. This guideline

does not apply to Medicare or Medicaid plans. Supporting Information and Clinical Evidence Background

Home infusion as a place of service is well established and accepted by physicians. A 2010 home infusion provider survey by the National Home Infusion Association reported providing 1.24 million therapies to approximately 829,000 patients, including 129,071 infusion therapies of specialty medications.

Clinical Evidence

MCG™ Care Guidelines, 21st edition, 2017, Home Infusion Therapy, CMT:




REVISED



Sep. 1, 2017

CMT-0009(SR) addresses criteria for home infusion therapy. Clinical patient characteristics for home suitability include: clinical stability, no need for close observation or daily nurse care, and reliable venous access. Additional

criteria for home environment, infusion plan and patient ability to participate in care are summarized.

Professional Societies

American Academy of Allergy Asthma and Immunology

The American Academy of Allergy Asthma and Immunology has published guidelines for the suitability of patients to receive treatment in various care setting including clinical characteristics of patients needing a high level of care in the hospital outpatient facility which includes patient characteristics: previous serious infusion reaction such as anaphylaxis, seizure, myocardial infarction, or renal failure, immune globulin therapy naïve, continual

experience of moderate or serious infusion related adverse reactions, physical or cognitive impairment.

Hunter Syndrome European Expert Council

European recommendations for the diagnosis and multidisciplinary management of a rare disease published an article reviewing the collective experiences with agalsidase beta home infusion therapy and outlines how safe, patient-centered homecare can be organized in enzyme replacement therapy for patients with Fabry disease. Criteria include that “Patients must

have received ERT in hospital for 3-6 months; if patients have previously had IRRs, they must be under control with premedication, and they must not have had an IRR in the 2-8 weeks before homecare is approved and premedication must be given. If a patient has significant respiratory disease (%FVC, 40% or less; or evidence of serious obstructive airway disease), homecare may not be suitable.”

Agency for Healthcare Research and Quality (AHRQ)

The Agency for Healthcare Research and Quality (AHRQ) publication on

Enzyme Replacement Therapy states, “Home infusion of ERT was initially studied in patients with type I Gaucher disease. It has been reported as an option for patients with Fabry disease, MPS I, and MPS II, and MPS VI. However, patients with infantile Pompe disease may not be able to transfer to home care because of an increased risk for serious adverse events during an infusion. In general, the outcomes measured in these studies and the




REVISED



Sep. 1, 2017

follow-up durations were similar to those reported by disease in the clinical studies summarized under Guiding Question 3. Safety was the main focus of most home infusion studies, as the patients had already been receiving ERT

in a more controlled setting.”

Medication or Condition Specific Studies

In a trial evaluating patients with paroxysmal nocturnal hemoglobinuria, after initial 2-5 doses of eculizumab (Soliris), 79 patients received continued infusion with every 14 days in the home setting for the duration of the study – 1-98 months, mean duration of 39 months. The survival of patients treated with eculizumab was not different from age- and sex-matched normal controls (P = .46) but was significantly better than 30 similar patients

managed before eculizumab (P = .030). Three patients on eculizumab, all over 50 years old, died of causes unrelated to PNH. Twenty-one patients (27%) had a thrombosis before starting eculizumab (5.6 events per 100 patient-years) compared with 2 thromboses on eculizumab (0.8 events per 100 patient-years; P < .001). Twenty-one patients with no previous thrombosis discontinued warfarin on eculizumab with no thrombotic

sequelae. Forty of 61 (66%) patients on eculizumab for more than 12

months achieved transfusion independence. The 12-month mean transfusion requirement reduced from 19.3 units before eculizumab to 5.0 units in the most recent 12 months on eculizumab (P < .001). Eculizumab dramatically alters the natural course of PNH, reducing symptoms and disease complications as well as improving survival to a similar level to that of the general population.

Infliximab has been shown to be safely infused in the community setting. A chart review of 3161 patients who received a combined 20,976 infusions in community clinics was conducted to evaluate safety across all types of patients. Infliximab infusions are safe in the community setting. Severe ADRs

were rare. A total of 524 (2.5% of all infusions) acute ADRs in 353 patients (11.2%) were recorded. Most reactions (ie, ADRs) were mild (n=263

[50.2%, 1.3% of all infusions]) or moderate (n=233 [44.5%, 1.1% of all infusions]). Twenty-eight reactions (5.3%, 0.1% of all infusions) were severe. Emergency medical services were called to transport patients to hospital for seven of the severe reactions, of which none required admission. As per pre-established medical directives adrenaline was administered three times. The authrors concluded that infliximab infusions are safe in the community setting. Severe ADRs were rare. None required active physician




REVISED



Sep. 1, 2017

intervention; nurses were able to treat all reactions by following standardized medical directives.7 Ten children were enrolled in the home infusion program if they were compliant with hospital-based infliximab infusions and other

medications, had no adverse events during hospital-based infliximab infusions, were in remission and had access to experienced pediatric homecare nursing. The children received 59 home infusions with a dose

range of 7.5 to 10 mg/kg/dose. Home infusions ranged from 2 to 5 hours. Since infusions could be performed any day of the week, school absenteeism was decreased. The average patient satisfaction rating for home infusions was 9 on a scale from 1 to 10 (10 = most satisfied). Three patients

experienced difficulty with IV access requiring multiple attempts, but all were able to receive their infusions. One infusion was stopped because of arm pain above the IV site. This patient had his next infusion in the hospital before returning to the home infusion program. No severe adverse events (palpitations, blood pressure instability, hyperemia, respiratory symptoms) occurred during home infusions. In the carefully selected patients, infliximab

infusions administered at home were safe and are cost-effective. Patients and families preferred home infusions, since time missed from school and

work was reduced.

08/01/17: commercial medical policy update bulletin ... · 2 medical policy update bulletin: august...

Documents