february 2018 medical policy update bulletin - … medical policy update bulletin: february 2018...

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.

February 2018

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

2 Medical Policy Update Bulletin: February 2018

Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates

Overview

Tips for using the Medical Policy Update Bulletin:

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

directed to the corresponding policy update summary.

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

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

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review

requirements have been adopted for a health service (e.g., test, drug,

device or procedure)

Updated

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

to the clinical coverage criteria or documentation review requirements;

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

list(s) of applicable codes may have been updated

Revised

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

the clinical coverage criteria and/or documentation review requirements

Replaced

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

Retired

The health service(s) addressed in the policy are no longer being

managed or are considered to be proven/medically necessary and are

therefore not excluded as unproven/not medically necessary services,

unless coverage guidelines or criteria are otherwise documented in

another policy

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

coverage. As always, coverage for a health service must be determined

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

federal or state regulatory requirements. Additionally, UnitedHealthcare

reserves the right to review the clinical evidence supporting the safety

and effectiveness of a medical technology prior to rendering a coverage

determination.

This bulletin provides complete details on UnitedHealthcare Medical

Policy, Medical Benefit Drug Policy, Coverage Determination

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

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

health service (e.g., test, drug, device or procedure) in this bulletin

indicates only that UnitedHealthcare has recently adopted a new

policy and/or updated, revised, replaced or retired an existing

policy; it does not imply that UnitedHealthcare provides coverage

for the health service. In the event of an inconsistency or conflict

between the information provided in this bulletin and the posted

policy, the provisions of the posted policy will prevail. Note that

most benefit plan documents exclude from benefit coverage health

services identified as investigational or unproven/not medically

necessary. Physicians and other health care professionals may not

seek or collect payment from a member for services not covered by

the applicable benefit plan unless first obtaining the member’s

written consent, acknowledging that the service is not covered by

the benefit plan and that they will be billed directly for the service.

The complete library of UnitedHealthcare Medical

Policies, Medical Benefit Drug Policies, CDGs, URGs,

and QOCGs is available at UHCprovider.com > 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




Medical Policy, Medical Benefit Drug Policy & Coverage Determination Guideline Updates

In This Issue

Medical Policy Updates Page

UPDATED

Epidural Steroid and Facet Injections for Spinal Pain - Effective Feb. 1, 2018 ........................................................................................................... 4 Fecal Calprotectin Testing - Effective Feb. 1, 2018 ................................................................................................................................................ 5 Glaucoma Surgical Treatments - Effective Mar. 1, 2018 ......................................................................................................................................... 5 Home Hemodialysis - Effective Feb. 1, 2018 ........................................................................................................................................................ 6 Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions - Effective Feb. 1, 2018 ............................................................ 7 Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions - Effective Apr. 1, 2018 ............................................................ 7

REVISED

Balloon Sinus Ostial Dilation - Effective Apr. 1, 2018 ............................................................................................................................................. 8 Electrical Stimulation for the Treatment of Pain and Muscle Rehabilitation - Effective Mar. 1, 2018 ............................................................................. 8 Functional Endoscopic Sinus Surgery (FESS) - Effective Apr. 1, 2018 .................................................................................................................... 11 Outpatient Cardiac Telemetry - Effective Mar. 1, 2018 ........................................................................................................................................ 12 Sodium Hyaluronate - Effective Mar. 1, 2018 ..................................................................................................................................................... 12 Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins - Effective Mar. 1, 2018 ...................................................................... 14 Transcranial Magnetic Stimulation - Effective Mar. 1, 2018 .................................................................................................................................. 18 Whole Exome and Whole Genome Sequencing - Effective Mar. 1, 2018 ................................................................................................................. 19

Medical Benefit Drug Policy Updates

NEW

Luxturna™ (Voretigene Neparvovec-Rzyl) - Effective Jan. 19, 2018 ...................................................................................................................... 25

Utilization Review Guideline (URG) Updates

REVISED

Office Based Program - Effective Apr. 1, 2018 .................................................................................................................................................... 26


Medical Policy Updates

Policy Title Effective Date Summary of Changes Coverage Rationale

UPDATED

Epidural Steroid and Facet Injections for

Spinal Pain

Feb. 1, 2018

Updated coverage rationale; replaced language indicating: o “[The listed services] are

proven and medically necessary” with “[the listed services] are proven and/or

medically necessary” o “[The listed services] are

unproven and not medically necessary” with “[the listed

services] are unproven and/or not medically necessary”

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

information, and references

Note: Epidural steroid injections in this policy apply to the lumbar spine only. This section does not address cervical or thoracic injections.

The facet joint injections section of the policy addresses multiple sites, and is not limited to the lumbar spine. Ultrasound Guidance

The use of ultrasound guidance for epidural steroid injection(s) and facet joint injection(s) is unproven and/or not medically necessary. There is insufficient clinical evidence regarding its safety and/or efficacy in published peer-reviewed medical literature. Epidural Steroid Injections

Epidural steroid injection is proven and/or medically necessary for

treating acute and sub-acute sciatica or radicular pain of the low back caused by spinal stenosis, disc herniation or degenerative changes in the vertebrae. Epidural steroid injections have a clinically established role in the short-term

management of low back pain when the following two criteria are met: The pain is associated with symptoms of nerve root irritation and/or low

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

The pain is unresponsive to conservative treatment, including but not limited to pharmacotherapy, exercise or physical therapy.

Epidural steroid injection is unproven and/or not medically necessary for ALL other indications of the lumbar spine. There is a lack of evidence from randomized controlled trials indicating that

epidural steroid injections effectively treat patients with lumbar pain not associated with sciatica or radicular pain.

Note: This policy does not apply to obstetrical epidural anesthesia utilized during labor and delivery. Facet Joint Injections

Diagnostic facet joint injection and/or facet nerve block (e.g., medial branch block) is proven and/or medically necessary to localize the

source of pain to the facet joint in persons with spinal pain. Therapeutic facet joint injection is unproven and/or not medically




UPDATED

Epidural Steroid and Facet Injections for

Spinal Pain (continued)

Feb. 1, 2018 necessary for treating chronic spinal pain. Clinical evidence about the very existence of facet joint syndrome is conflicting, and evidence from studies is inadequate regarding the superiority

of periodic facet joint injections compared to placebo in relieving chronic spinal pain (pain lasting more than 3 months).

For additional information on facet joint injections as a diagnostic procedure prior to radiofrequency ablation, see Clinical Evidence.

Fecal Calprotectin Testing

Feb. 1, 2018 Updated coverage rationale; replaced language indicating “fecal measurement of calprotectin is unproven and not medically necessary” with “fecal measurement of calprotectin is

unproven and/or not medically necessary”

Updated supporting information

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

Fecal measurement of calprotectin is unproven and/or not medically necessary for the diagnosis and management of all conditions including but not limited to the following: Inflammatory bowel disease (IBD) including ulcerative colitis (UC) and

Crohn's disease (CD) Colorectal cancer (CRC)

There is insufficient evidence that fecal calprotectin (FC) is effective as a biomarker for the diagnosis and management of intestinal disease. Before FC

can be incorporated into routine clinical practice, studies in larger and diverse groups of patients will be needed to further clarify its role in clinical decision making and its effect on the outcome of treatment of the condition for which it is being used.

Glaucoma Surgical Treatments

Mar. 1, 2018

Updated coverage rationale; replaced language indicating: o “[The listed services] are

proven and medically

necessary” with “[the listed services] are proven and/or medically necessary”

o “[The listed services] are unproven and not medically necessary” with “[the listed services] are unproven

and/or not medically necessary”

Updated list of applicable CPT codes; revised description for 66180

Glaucoma drainage devices, such as the ExPRESS™ mini glaucoma shunt, Molteno implant, Baerveldt tube shunt, Krupin Eye Valve, or the Ahmed glaucoma valve implant, are proven and/or medically necessary for treating refractory glaucoma when conventional

medical or surgical treatments have failed or are inappropriate. The iStent® Trabecular Micro-Bypass Stent System is proven and/or

medically necessary when used in combination with cataract surgery for treating mild to moderate open-angle glaucoma and a cataract in adults currently being treated with ocular hypotensive medication.

The CyPass® Micro-Stent System is unproven and/or not medically necessary when used in combination with cataract surgery for treating mild-to-moderate primary open-angle glaucoma (POAG). The Xen® Glaucoma Treatment System is unproven and/or is not




UPDATED

Glaucoma Surgical Treatments (continued)

Mar. 1, 2018 Updated supporting information to reflect the most current description of services, clinical

evidence, FDA and CMS information, and references

medically necessary for treating refractory glaucoma when conventional medical or surgical treatments have failed, or in patients with primary open-angle glaucoma, pseudoexfoliative or

pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy.

Glaucoma drainage devices, such as Eyepass, DeepLight SOLX® Gold Shunt and other shunts that do not have FDA approval are investigational and unproven and/or not medically necessary for treating glaucoma.

Clinical evidence is limited to small studies; therefore, additional studies are needed to establish the safety and efficacy of these devices. Canaloplasty is proven and/or medically necessary for treating primary open-angle glaucoma.

Viscocanalostomy is unproven and/or not medically necessary for treating glaucoma.

Evidence from the majority of available randomized controlled trials indicates that viscocanalostomy is not as effective as trabeculectomy in reducing intraocular pressure (IOP).

Home Hemodialysis

Feb. 1, 2018

Updated and reorganized coverage rationale; replaced language indicating “[the listed services] are proven and medically necessary” with “[the listed services] are proven and/or medically necessary”

Updated supporting information

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

Home hemodialysis without professional staff assistance is proven and/or medically necessary as an alternative to facility-based hemodialysis for treating patients with end-stage renal disease who meet ALL of the following criteria: Patient is stable on dialysis with no evidence of complex skilled

interventions being necessary during treatments; and Patient or non-professional caregiver has the ability to perform and

maintain home hemodialysis and has received comprehensive training

regarding proper protocol; and Absence of complications and significant concomitant disease that would

cause home hemodialysis to be unsafe or unsuitable; and Presence of well-functioning vascular access.

Home hemodialysis with professional staff assistance is proven and/or medically necessary as an alternative to facility-based hemodialysis for treating patients with end-stage renal disease who meet ALL of the following criteria:




UPDATED

Home Hemodialysis (continued)

Feb. 1, 2018 Patient is stable on dialysis and not at increased risk as a result of having the procedure performed outside a dialysis center venue; and

Patient has well-functioning vascular access; and

Patient has medical contraindications to leaving home for hemodialysis; and

Patient or non-professional caregiver is not capable of performing home

hemodialysis; and Staff assisted home hemodialysis protocols generally match those

provided in the hemodialysis center (i.e., at least 3 times per week, 3-4 hour treatments). The exact dialysis therapy employed is determined on

an individual basis by the attending nephrologist.

Molecular Oncology Testing for Cancer Diagnosis,

Prognosis, and Treatment Decisions

Feb. 1, 2018 Updated list of applicable CPT codes to reflect annual code edits; added 0011M

Refer to the policy for complete details on the coverage guidelines for Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment Decisions.

Molecular Oncology Testing for Cancer

Diagnosis, Prognosis, and Treatment Decisions

Apr. 1, 2018 Updated coverage rationale; replaced language indicating:

o “[The listed services] are proven and medically necessary” with “[the listed services] are proven and/or medically necessary”

o “[The listed services] are

unproven and not medically necessary” with “[the listed services] are unproven

and/or not medically necessary”

o Replaced reference to “patient” with “individual”

Updated list of applicable CPT codes; added 81520 and 81521

Refer to the policy for complete details on the coverage guidelines for Molecular Oncology Testing for Cancer Diagnosis, Prognosis, and Treatment

Decisions.




REVISED

Balloon Sinus Ostial Dilation

Apr. 1, 2018 Revised coverage rationale; replaced language indicating: o “Balloon sinus ostial dilation

is medically necessary for treating Chronic Rhinosinusitis” with “balloon

sinus ostial dilation is proven and/or medically necessary for treating Chronic Rhinosinusitis”

o “Balloon sinus ostial dilation is not medically necessary for treating nasal polyps or tumors” with “balloon sinus ostial dilation is unproven and/or not medically

necessary for treating nasal polyps or tumors”

Updated list of applicable CPT codes; added 31298

Balloon sinus ostial dilation is proven and/or medically necessary for treating Chronic Rhinosinusitis (defined as rhinosinusitis lasting longer than 12 weeks) when all of the following are met:

Chronic Rhinosinusitis of the sinus to be dilated is confirmed on computed tomography (CT) scan. CT scan findings of Chronic Rhinosinusitis include one or more of the following:

o Mucosal thickening, o Bony remodeling, o Bony thickening, or o Obstruction of the ostiomeatal complex.

Balloon sinus ostial dilation is limited to the frontal, maxillary or sphenoid sinuses.

Balloon sinus ostial dilation is performed either as a stand-alone procedure or as part of Functional Endoscopic Sinus Surgery (FESS).

Balloon sinus ostial dilation is performed in persons whose symptoms persist despite medical therapy with one or more of the following:

o Nasal lavage o Antibiotic therapy, if bacterial infection is suspected

o Intranasal corticosteroids Balloon sinus ostial dilation is unproven and/or not medically necessary for treating nasal polyps or tumors. There is insufficient published clinical evidence to conclude that balloon sinus

ostial dilation is safe and effective for treating nasal polyps or tumors.

Electrical Stimulation for the Treatment of Pain and Muscle

Rehabilitation

Mar. 1, 2018

Revised coverage rationale: o Added language to indicate

percutaneous electrical nerve stimulation (PENS) or

percutaneous

neuromodulation therapy (PNT) is unproven and not medically necessary for treating pain There is limited evidence

in the peer reviewed literature to support that PENS or PNT will improve health outcomes

When used for walking, functional electrical stimulation (FES), a form of neuromuscular electrical stimulation (NMES), is proven and medically necessary when used as one component of a comprehensive rehabilitation program in persons with paralyzed

lower limbs due to spinal cord injury (SCI) with all of the following

characteristics: Intact lower motor units (L1 and below) (both muscle and peripheral

nerves) Muscle and joint stability for weight bearing at upper and lower

extremities that can demonstrate balance and control to maintain an

upright support posture independently; Demonstrate brisk muscle contraction to NMES and have sensory

perception of electrical stimulation (ES) sufficient for muscle contraction; Possess high motivation, commitment and cognitive ability to use such




REVISED

Electrical Stimulation for the Treatment of Pain

and Muscle Rehabilitation (continued)

Mar. 1, 2018

in patients with pain Randomized controlled

trials assessing larger

patient groups and long-term follow up are needed to further clarify

its role o Removed language

indicating a description of dorsal root ganglion

neurostimulation devices is located in the U.S. Food and Drug Administration (FDA) section of the policy

Updated list of applicable HCPCS codes; removed L8683

Updated supporting information to reflect the most current

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

devices for walking; Able to transfer independently and demonstrate independent standing

tolerance for at least 3 minutes;

Demonstrate hand and finger function to manipulate controls; Post recovery from SCI and restorative surgery of at least 6-months; No hip and knee degenerative disease and no history of long bone

fracture secondary to osteoporosis FES is unproven and not medically necessary for treating ANY other indication not listed above as proven and medically necessary,

including but not limited to: Disuse muscle atrophy in persons with SCI Disuse muscle atrophy in persons with multiple sclerosis (MS) Gait disorders (e.g., foot drop) of central neurologic origin, including but

not limited to stroke or MS

Further studies are needed to confirm that FES promotes bone remineralization and prevents or reverses muscle atrophy. Only a few studies

have looked at FES as a modality of treatment of MS, and the results are limited and conflicting regarding whether FES improves treatment outcomes in MS when offered in addition to other rehabilitative treatment modalities. There is insufficient evidence in the peer reviewed literature that use of FES will improve health outcomes in patients with gait disorders. Published

studies have included small heterogeneous patient populations, short-term follow-ups, and various treatment protocols, outcome measures, and FES devices. NMES is proven and medically necessary for treating the following indications: Disuse muscle atrophy if:

o The nerve supply to the muscle is intact; and o The disuse muscle atrophy is not of neurological origin but originates

from conditions such as casting, splinting or contractures. To improve wrist and finger function and prevent or correct shoulder

subluxation in persons with partial paralysis following stroke

NMES is unproven and not medically necessary for treating ANY other indication not listed above as proven and medically necessary. There is insufficient evidence in the peer reviewed literature that use of ES




REVISED



Mar. 1, 2018

will improve health outcomes for the treatment of multiple conditions other than those identified above as proven. Overall, studies in the form of randomized controlled trials (RCTs) and case series included small,

heterogeneous patient populations and short-term follow-ups. Some systematic reviews have reported that no improvement was seen with NMES, outcomes were conflicting and/or in some cases, when improvement was

noted, the effects did not last. Heterogeneity of treatment regimens and outcome measures make it difficult to establish that NMES resulted in meaningful clinical outcomes (e.g., decrease pain, functional improvement, improvement in quality of life (QOL) and ability to carry out activities of daily

living (ADLs)) for these other conditions and indications. Interferential therapy (IFT) is unproven and not medically necessary for treating the following indications: For the treatment of musculoskeletal disorders or injuries For stimulating healing of nonsurgical soft tissue injuries

To facilitate the healing of bone fractures

There is limited evidence from the available studies to conclude that IFT reduces the pain or promotes healing of bone fractures, musculoskeletal or nonsurgical soft tissue injuries. Although a few studies reported some improvement in pain or disability following IFT for these conditions, none of the double-blind, randomized, placebo-controlled studies reported a positive

treatment effect of IFT for nonsurgical soft tissue injuries or bone fractures. Pulsed electrical stimulation (PES) is unproven and not medically necessary for treating osteoarthritis (OA). There is insufficient evidence to conclude that PES provides health benefits to patients with OA. RCTs are necessary to assess the durability of this procedure in comparison to other types of treatment.

Peripheral subcutaneous field stimulation (PSFS) or peripheral nerve field stimulation (PNFS) is unproven and not medically necessary for treating pain. Evidence for the effectiveness of PSFS or PNFS based on controlled studies is lacking. RCTs are needed to evaluate the efficacy of this treatment.

Microcurrent electrical nerve stimulation (MENS) therapy is unproven and not medically necessary.




REVISED



Mar. 1, 2018 There is insufficient evidence to conclude that MENS is safe and effective. Robust clinical trials are needed to evaluate this therapy in comparison to other types of treatment.

Percutaneous electrical nerve stimulation (PENS) or percutaneous neuromodulation therapy (PNT) is unproven and not medically necessary for treating pain.

There is limited evidence in the peer reviewed literature to support that PENS or PNT will improve health outcomes in patients with pain. RCTs assessing larger patient groups and long-term follow up are needed to further clarify its role.

Dorsal root ganglion (DRG) stimulation is unproven and not medically necessary. There is limited evidence in the peer reviewed literature to support that DRG stimulation will improve health outcomes in patients with pain. RCTs assessing larger patient groups and long-term follow up are needed to

further clarify its role.

Functional Endoscopic Sinus Surgery (FESS)

Apr. 1, 2018 Revised coverage rationale; replaced language indicating “functional endoscopic sinus surgery (FESS) is medically

necessary for [the listed indications]” with “functional endoscopic sinus surgery (FESS) is proven and/or medically necessary for [the listed indications]”

Updated list of applicable CPT

codes; added 31253, 31257, and

31259

Functional endoscopic sinus surgery (FESS) is proven and/or 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)




REVISED

Outpatient Cardiac Telemetry

Mar. 1, 2018 Changed policy title; previously titled Outpatient Cardiovascular Telemetry

Revised coverage rationale: o Replaced references to

“outpatient cardiovascular

telemetry” with “outpatient cardiac telemetry”

o Replaced language indicating:

“Outpatient cardiovascular telemetry is proven and medically necessary for the [listed] indications” with “outpatient cardiac

telemetry is proven and/or medically

necessary for the [listed] indications”

“Event monitors may be used for a short duration (e.g., 24-48 hours)” with

“event monitors may be used for a short duration (e.g., 3-14 days)”

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

Outpatient cardiac telemetry is proven and/or medically necessary for the following indications: Suspected cardiac arrhythmia not detected with standard cardiac event

monitoring* Cryptogenic stroke with suspected occult atrial fibrillation as the cause of

the stroke

Monitoring arrhythmia status following an ablation procedure *Standard cardiac event monitoring includes non-implantable cardiac event monitors that record cardiac events for days, weeks or months. Event

recording may be patient activated or automatically collected. The patient then periodically telephones events to a central collection area. Standard cardiac event monitoring must be of sufficient duration to detect a cardiac arrhythmia under consideration. Event monitors may be used for a short duration (e.g., 3-14 days) or for a longer period (e.g., 14-30 days or longer). A physician who suspects an occult arrhythmia will order event monitoring

for a longer time period; therefore, non-diagnostic 24-48 hour Holter monitoring to detect a cardiac arrhythmia would not be an indication for

outpatient cardiac telemetry.

Sodium Hyaluronate

Mar. 1, 2018

Revised coverage rationale: o Updated list of U.S. Food and

Drug Administration (FDA) labeled indications for

administration of intra-articular injections of sodium hyaluronate: Added:

Intra-articular injections of sodium hyaluronate are proven and/or medically necessary for treating pain due to osteoarthritis (OA) of the knee when administered according to U.S. Food and Drug Administration (FDA) labeled indications.

FDA Labeling*

Durolane 1 injection




REVISED

Sodium Hyaluronate (continued)

Mar. 1, 2018

- Durolane (1 injection)

- Visco-3 (3 injections)

Replaced “Gel-Syn (3 injections)” with “Gelsyn-3 (3 injections)”

o Replaced language indicating: “[The listed services] are

proven and medically

necessary” with “[the listed services] are proven and/or medically necessary”

“[The listed services] are unproven and not

medically necessary” with “[the listed

services] are unproven and/or not medically necessary”

Updated supporting information to reflect the most current

clinical evidence and FDA information

Euflexxa 3 injections

Gel One 1 injection

Gelsyn-3 3 injections

Gen Visc 850 3 to 5 injections

Hyalgan 5 injections

Hymovis 2 injections

Monovisc 1 injection

Orthovisc 3 to 4 injections

Supartz 3 to 5 injections

Synvisc 3 injections

Synvisc One 1 injection

Visco-3 3 injections

*Hyaluronic acid preparations for the treatment of pain due to OA of the

knee are deemed therapeutically equivalent. The UnitedHealth Group

National Pharmacy and Therapeutics Committee has defined as therapeutically equivalent, products that can be expected to produce essentially the same therapeutic outcome and toxicity. Note: There is no evidence that use of one intra-articular hyaluronan product is superior to another.

Repeated courses of intra-articular hyaluronan injections may be considered under the following conditions: Significant pain relief was achieved with the prior course of injections;

and

Pain has recurred; and At least 6 months have passed since the prior course of treatment.

Intra-articular injections of sodium hyaluronate are proven and/or medically necessary for treating temporomandibular joint (TMJ) disc displacement and OA. Sodium hyaluronate preparations are unproven and/or not medically necessary for treating any other indication not listed above as




REVISED

Sodium Hyaluronate (continued)

Mar. 1, 2018 proven, including but not limited to: Pain due to OA in any joint other than the knee or TMJ Any other form of arthritis (including rheumatoid arthritis (RA))

Patello-femoral syndrome Chondromalacia of the knee Following total or partial knee joint replacement

Increase in viscoelasticity of synovial fluid after sodium hyaluronate injection has not been demonstrated in patients with RA, and it has not been determined whether sodium hyaluronate is protective in joints affected by

RA. Further studies are needed to determine the safety and durability of such treatment for patello-femoral syndrome and chondromalacia of the knee and whether it significantly delays the need for more invasive treatment (e.g., surgery, joint replacement or arthroplasty). There are no clinical studies evaluating the use of sodium hyaluronate in persons following total or partial knee joint replacement surgery.

Hyaluronic acid gel preparations to improve the skin's contour

and/or reduce depressions due to acne, scars, injury or wrinkles are considered cosmetic. The use of sodium hyaluronate preparations to improve the skin's contour and/or reduce depressions in the skin due to acne, scars, injury or wrinkles improves physical appearance but does not remove or improve a functional

impairment of the skin.

Surgical and Ablative Procedures for Venous Insufficiency and

Varicose Veins

Mar. 1, 2018

Replaced references to “patient” with “individual”

Revised coverage rationale: o Replaced reference to:

“Greater Saphenous”

with “Greater Saphenous Veins”

“Small saphenous” with “Small Saphenous Veins”

o Replaced language

indicating: “Radiofrequency

ablation, endovenous laser ablation, Stripping,

Varicose Vein Ablative and Stripping Procedures

Radiofrequency ablation, endovenous laser ablation, Stripping, Ligation and excision of the Great Saphenous Vein and Small Saphenous Veins are considered reconstructive, proven and/or medically necessary when ALL of the following criteria are present:

Junctional Reflux (see Definitions section of the policy):

o Ablative therapy for the Great Saphenous Veins or Small Saphenous Veins will be considered reconstructive and therefore medically necessary only if Junctional Reflux is demonstrated in these veins; or

o Ablative therapy for Accessory Veins will be considered reconstructive and medically necessary only if anatomically related persistent Junctional Reflux is demonstrated after the Great

Saphenous Veins or Small Saphenous Veins have been removed or ablated.




REVISED

Surgical and Ablative Procedures for Venous

Insufficiency and Varicose Veins (continued)

Mar. 1, 2018

Ligation and excision of the Great Saphenous Vein and Small

Saphenous Veins are considered reconstructive and

medically necessary when all of the [listed] criteria are present” with “radiofrequency ablation,

endovenous laser ablation, Stripping, Ligation and excision of the Great Saphenous Vein and Small Saphenous Veins are

considered reconstructive, proven

and/or medically necessary when all of the [listed] criteria are present”

“Ablation of perforator

veins is considered reconstructive and medically necessary when the [listed] criteria are present” with “ablation of perforator veins is considered

reconstructive, proven and/or medically necessary when the [listed] criteria are present”

“Ligation at the

saphenofemoral junction, as a stand-alone procedure, is proven and

Member must have one of the following functional impairments: o Skin ulceration; or o Documented episode(s) of frank bleeding of the Varicose Vein due to

erosion of/or trauma to the skin; or o Documented Superficial Thrombophlebitis or documented Venous

Stasis Dermatitis; or

o Moderate to severe pain causing Functional/Physical Impairment. Venous Size:

o The Great Saphenous Vein must be 5.5 mm or greater when measured at the proximal thigh immediately below the

saphenofemoral junction via Duplex Ultrasonography. o The Small Saphenous Vein or Accessory Veins must measure 5 mm

or greater in diameter immediately below the appropriate junction. Duration of reflux, in the standing or reverse Trendelenburg position that

meets the following parameters: o Greater than or equal to 500 milliseconds (ms) for the Great

Saphenous vein, Small Saphenous Veins or principle tributaries. o Perforating veins > 350 ms.

o Some Duplex Ultrasound readings will describe this as moderate to severe reflux which will be acceptable.

Ablation of perforator veins is considered reconstructive, proven and/or medically necessary when the following criteria are present:

Evidence of perforator Venous Insufficiency measured by recent Duplex Ultrasonography report (see criteria above); and

Perforator vein size is 3.5 mm or greater; and Perforating vein lies beneath a healed or active venous stasis ulcer. Endovenous mechanochemical ablation (MOCA) of Varicose Veins using a percutaneous infusion catheter is unproven and/or not

medically necessary for treating Venous Reflux. There is insufficient evidence in the clinical literature supporting the safety and efficacy of MOCA for treating Varicose Veins. Further results from large, well-designed studies are needed to support the clinical utility of this approach. Ligation Procedures

Ligation of the Great Saphenous Vein at the saphenofemoral junction, as a stand-alone procedure, is unproven and/or not




REVISED



Mar. 1, 2018

medically necessary, when used to prevent the propagation of an

active clot to the deep venous system in individuals with

ascending Superficial Thrombophlebitis who fail or are intolerant of anticoagulation therapy”

with “ligation at the saphenofemoral junction, as a stand-alone procedure, is proven and/or medically necessary, when used to

prevent the propagation of an active clot to the

deep venous system in individuals with ascending Superficial Thrombophlebitis who fail or are intolerant of

anticoagulation therapy” “Endovenous foam

sclerotherapy of incompetent Great Saphenous Veins and accessory saphenous veins is unproven and

not medically necessary for treating Venous Reflux” with “endovenous foam sclerotherapy of incompetent Great

Saphenous Veins, lesser saphenous veins, and accessory saphenous

medically necessary for treating venous reflux. Ligation performed without Stripping or ablation is associated with high long-term recurrence rates due to neovascularization.

Ligation of the Small Saphenous Vein at the saphenopopliteal junction, as a stand-alone procedure, is unproven and/or not

medically necessary for treating Venous Reflux. Ligation performed without Stripping or ablation is associated with high long-term recurrence rates due to neovascularization.

Ligation at the saphenofemoral junction, as a stand-alone procedure, is proven and/or medically necessary, when used to prevent the propagation of an active clot to the deep venous system in individuals with ascending Superficial Thrombophlebitis who fail or are intolerant of anticoagulation therapy.

Ligation at the saphenofemoral junction, as an adjunct to radiofrequency ablation or endovenous laser ablation of the main

saphenous veins, is unproven and/or not medically necessary for treating Venous Reflux. Published clinical evidence has not demonstrated that the addition of saphenofemoral ligation to Endovenous Ablation procedures provides an additive benefit in resolving Venous Reflux or preventing Varicose Vein

recurrence. Endovenous Ablation is a clinically effective therapy for treating Venous Reflux. Adding Ligation to the procedure adds clinical risk without adding clinical benefit. Endovascular embolization of Varicose Veins using cyanoacrylate-based adhesive is unproven and/or not medically necessary for treating Venous Reflux.

There is insufficient evidence in the published clinical literature supporting the safety and efficacy of endovascular embolization using cyanoacrylate-based adhesive for treating Varicose Veins. Further long-term results from large, well-designed studies are needed to support the clinical utility of this approach.

Endovenous foam sclerotherapy of incompetent Great Saphenous Veins, lesser saphenous veins, and accessory saphenous veins is unproven and/or not medically necessary for treating Venous Reflux.




REVISED



Mar. 1, 2018

veins is unproven and/or not medically necessary for treating Venous

Reflux” o Replaced language indicating

“[the services listed below]

are unproven and not medically necessary” with “[the services listed below] are unproven and/or not

medically necessary”: Endovenous

mechanochemical ablation (MOCA) of Varicose Veins using a percutaneous infusion

catheter for treating Venous Reflux

Ligation of the Great Saphenous Vein at the saphenofemoral junction, as a stand-alone procedure for treating

Venous Reflux Ligation of the Small

Saphenous Vein at the saphenopopliteal junction, as a stand-alone procedure for treating Venous Reflux

Ligation at the saphenofemoral junction, as an adjunct to radiofrequency ablation or endovenous laser ablation of the main

saphenous veins for treating Venous Reflux

Endovascular

There is insufficient evidence in the published clinical literature supporting the safety and efficacy of endovascular embolization using endovenous foam sclerotherapy for treating Varicose Veins. Further long-term results from

large, well-designed studies are needed to support the clinical utility of this approach.




REVISED



Mar. 1, 2018

embolization of Varicose Veins using cyanoacrylate-based

adhesive for treating Venous Reflux

Updated definition of:

o Congenital Anomaly o Congenital Anomaly

(California only) o Cosmetic Procedures

o Cosmetic Procedures (California only)

o High Quality Photograph o Reconstructive Procedures o Reconstructive Procedures

(California only)

o Sickness Updated supporting information

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

Transcranial Magnetic Stimulation

Mar. 1, 2018

Revised coverage rationale: o Added language to indicate

transcranial magnetic stimulation is unproven and/or not medically necessary for treating Alzheimer’s disease

o Replaced language

indicating: “Transcranial magnetic

stimulation is unproven and not medically necessary for treating all

medical (i.e., non-behavioral) conditions including [those listed in the policy]” with

Transcranial magnetic stimulation is unproven and/or not medically necessary for treating all medical (i.e., non-behavioral) conditions including but not limited to: Alzheimer’s disease Chronic neuropathic pain Dystonia Epilepsy

Headaches

Parkinson’s disease Stroke Tinnitus For Behavioral Disorders, refer to the Optum Behavioral Solutions Coverage

Determination Guideline titled Transcranial Magnetic Stimulation (TMS) at Optum Provider Express > Clinical Resources > Guidelines/Policies/Manuals > Coverage Determination Guidelines.




REVISED

Transcranial Magnetic Stimulation

(continued)

Mar. 1, 2018 “transcranial magnetic stimulation is unproven and/or not medically

necessary for treating all medical (i.e., non-behavioral) conditions

including but not limited to [those listed in the policy]”

“Navigated transcranial

magnetic stimulation (nTMS) is unproven and not medically necessary for treatment planning or for diagnosing motor neuron diseases or

neurological disorders” with “navigated

transcranial magnetic stimulation (nTMS) is unproven and/or not medically necessary for treatment planning or for

diagnosing motor neuron diseases or neurological disorders”

Updated list of applicable CPT codes: o Added 64999 o Removed 95999

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

Some studies have examined the use of transcranial magnetic stimulation for treating disorders such as pain, dystonia, epilepsy, headaches, Parkinson’s disease, stroke, and tinnitus. However, because of limited studies and small

sample size there is insufficient data to conclude that transcranial magnetic stimulation is beneficial for treating these conditions.

Navigated transcranial magnetic stimulation (nTMS) is unproven and/or not medically necessary for treatment planning or for diagnosing motor neuron diseases or neurological disorders. There is limited information from the peer-reviewed published medical

literature to conclude that navigated transcranial magnetic stimulation is an effective clinical diagnostic test. Most published studies involve a small number of patients. Randomized controlled trials with large populations are needed to evaluate how this test can reduce clinical diagnostic uncertainty or impact treatment planning.

Whole Exome and Whole Genome Sequencing

Mar. 1, 2018

Updated list of related policies; added reference links to policies titled: o Chromosome Microarray

Genetic counseling is strongly recommended prior to these tests in order to inform persons being tested about the advantages and limitations of the test as applied to a unique person.




REVISED


(continued)

Mar. 1, 2018

Testing o Molecular Oncology Testing

for Cancer Diagnosis,

Prognosis, and Treatment Decisions

Revised coverage rationale:

o Modified language pertaining to Whole Exome Sequencing to indicate: Whole Exome

Sequencing (WES) is proven and/or medically necessary for diagnosing or evaluating a genetic disorder when the results are expected to

directly influence medical management and clinical

outcomes and all of the following criteria are met: - Clinical presentation

is nonspecific and

does not fit a well-defined syndrome for which a specific or targeted gene test is available; if a specific genetic syndrome is

suspected, a single gene or targeted gene panel should be performed prior to determining if WES is necessary; and

- WES is ordered by a board-certified medical geneticist,

Whole Exome Sequencing (WES)

Whole Exome Sequencing (WES) is proven and/or medically necessary for diagnosing or evaluating a genetic disorder when the results are expected to directly influence medical management and clinical outcomes AND ALL of the following criteria are met:

Clinical presentation is nonspecific and does not fit a well-defined

syndrome for which a specific or targeted gene test is available. If a specific genetic syndrome is suspected, a single gene or targeted gene panel should be performed prior to determining if WES is necessary; and

WES is ordered by a board-certified medical geneticist, neonatologist, neurologist, or developmental and behavioral pediatrician; and

One of the following:

o The clinical presentation or clinical and family history strongly suggest a genetic cause for which a specific clinical diagnosis cannot be made with any clinically available targeted genetic tests; or

o There is a clinical diagnosis of a genetic condition where there is significant genetic heterogeneity and WES is a more practical approach to identifying the underlying genetic cause than are

individual tests of multiple genes; or

o There is likely a genetic disorder and multiple targeted gene tests that have failed to identify the underlying cause.

Comparator (e.g., parents or siblings) WES is proven and/or medically necessary for evaluating a genetic disorder when the above criteria have been met and WES is performed concurrently or

has been previously performed on the individual. WES is unproven and/or not medically necessary for all other indications, including but not limited to the following: Screening and evaluating disorders in individuals when the above criteria

are not met Prenatal genetic diagnosis or screening

Evaluation of fetal demise Preimplantation genetic diagnosis or screening in embryos Molecular profiling of tumors for the diagnosis, prognosis or management

of cancer Further studies are needed to evaluate the clinical utility of whole exome sequencing for other indications.




REVISED


(continued)

Mar. 1, 2018

neonatologist, neurologist, or developmental and

behavioral pediatrician; and

- One of the following:

The clinical presentation or clinical and family history

strongly suggest a genetic cause for which a specific clinical diagnosis cannot be made with

any clinically available

targeted genetic tests; or

There is a clinical diagnosis of a genetic condition

where there is significant genetic heterogeneity and WES is a more practical approach to

identifying the underlying genetic cause than are individual tests of multiple

genes; or There is likely a

genetic disorder

Whole Genome Sequencing (WGS)

Whole Genome Sequencing (WGS) is unproven and/or not medically necessary for screening and evaluating any genetic disorder. Although WGS has the potential to identify causal variants for a wide variety of conditions that may be missed with other technologies, as well as to

identify predictive biomarkers, the information derived from WGS has not yet

been translated into improved outcomes and changed medical management. Further studies are needed to establish the clinical utility of WGS.




REVISED


(continued)

Mar. 1, 2018

and multiple targeted gene tests that have

failed to identify the underlying cause

WES is unproven and/or not medically necessary for all other indications, including but not limited

to the following: - Screening and

evaluating disorders in individuals when the above criteria are not met

- Prenatal genetic diagnosis or

screening - Evaluation of fetal

demise - Preimplantation

genetic diagnosis or

screening in embryos - Molecular profiling of

tumors for the diagnosis, prognosis or management of cancer

o Replaced language

indicating: “Comparator (e.g.,

parents or siblings) WES is proven and medically necessary for evaluating a genetic disorder when

the above criteria have been met and WES is performed concurrently




REVISED


(continued)

Mar. 1, 2018

or has been previously performed on the patient” with

“comparator (e.g., parents or siblings) WES is proven and/or

medically necessary for evaluating a genetic disorder when the above criteria have been met

and WES is performed concurrently or has been previously performed on the individual”

“Whole Genome Sequencing (WGS) is

unproven and not medically necessary for

screening and evaluating any genetic disorder” with “Whole Genome Sequencing (WGS) is unproven and/or not

medically necessary for screening and evaluating any genetic disorder”

o Modified language pertaining to clinical evidence/study findings for Whole Genome Sequencing to indicate:

Although WGS has the potential to identify causal variants for a wide variety of conditions that may be missed with other

technologies, as well as to identify predictive biomarkers, the




REVISED


(continued)

Mar. 1, 2018 information derived from WGS has not yet been translated into improved

outcomes and changed medical management

Added definition of:

o Comparator o Next Generation Sequencing

(NGS) o Variant of Unknown

Significance (VUS) o Whole Exome Sequencing

(WES) o Whole Genome Sequencing

(WGS) Updated supporting information

to reflect the most current description of services, clinical

evidence, FDA information, and references


Medical Benefit Drug Policy Updates

Policy Title Effective Date Coverage Rationale

NEW

Luxturna™ (Voretigene Neparvovec-Rzyl)

Jan. 19, 2018 Luxturna is proven and/or medically necessary for the treatment of Inherited Retinal Dystrophies (IRD) caused by mutations in the retinal pigment epithelium-specific protein 65kDa (RPE65) gene in patients who meet ALL of the following criteria:

I. Patient is greater than 12 months of age; and II. Diagnosis of a confirmed biallelic RPE65 mutation-associated retinal dystrophy (e.g., Leber’s congenital

amaurosis [LCA], Retinitis pigmentosa [RP] Early Onset Severe Retinal Dystrophy [EOSRD], etc.); and

III. Genetic testing documenting biallelic mutations of the RPE65 gene; and IV. Sufficient viable retinal cells as determined by optical coherence tomography (OCT) confirming an area of retina

within the posterior pole of >100 µm thickness; and V. Prescribed and administered by ophthalmologist or retinal surgeon with experience providing sub-retinal

injections; and VI. Patient has not previously received RPE65 gene therapy in intended eye.


Utilization Review Guideline (URG) Updates

Policy Title Effective Date Summary of Changes Utilization Management Guiding Principles

REVISED

Office Based Program

Apr. 1, 2018 Reformatted and reorganized policy; transferred content to new template

Revised list of applicable CPT codes for elective procedures requiring prior authorization if

not performed in the office setting; removed 11606

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: Member specific benefit plan document

Geographic availability of an in-network provider Office capability (i.e., appropriate equipment) Significant member comorbidities 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 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).

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