Medical Policy and Coding Updates November 2020

Effective February 5, 2021

The following policies are being reinstated and used to review medical necessity for dates of service starting February 5, 2021 and after:

Adjustable Cranial Orthoses for Positional Plagiocephaly and Craniosynostoses, 1.01.11

Artificial Pancreas Device Systems, 1.01.30

Medical necessity criteria updated

• The age for an artificial pancreas device system has been lowered from age 14 to age 6 and older
• The age for a hybrid closed loop insulin delivery system has been lowered from age 7 to age 6 and older

Cochlear Implant, 7.01.05

Medical necessity criteria updated

• The age for bilateral hearing loss has been lowered from 12 months to 9 months or older

Continuous Passive Motion in the Home Setting, 1.01.10

Coronary Angiography for Known Suspected Coronary Artery Disease, 2.02.507

Deep Brain Stimulation, 7.01.63

Hip Arthroplasty in Adults, 7.01.573

Hospital Beds and Accessories, 1.01.520

Knee Arthroplasty in Adults, 7.01.550

Knee Arthroscopy in Adults, 7.01.549

Medical necessity criteria updated

• Knee arthroscopy for a partial meniscectomy is considered not medically necessary for a degenerative tear(s) that do not result in functional impairment symptoms

Knee Orthoses (Braces), Ankle foot Orthoses and Knee-Ankle-Foot-Orthoses, 1.03.501

Mastectomy for Gynecomastia, 7.01.521

Oscillatory Devices for the Treatment of Cystic Fibrosis and Other Respiratory Conditions, 1.01.15

Panniculectomy and Excision of Redundant Skin, 7.01.523

Patient Lifts, Seat Lifts, and Standing Devices, 1.01.519

Percutaneous Left Atrial Appendage Closure Devices for Stroke Prevention in Atrial Fibrillation, 2.02.26

Power Operated Vehicle (Scooters) (excluding motorized wheelchairs), 1.01.527

Pneumatic Compression Pumps for Treatment of Lymphedema and Venous Ulcers, 1.01.18

Reduction Mammoplasty for Breast Related Symptoms, 7.01.503

Responsive Neurostimulation for the Treatment of Refractory Focal Epilepsy, 7.01.143

Rhinoplasty, 7.01.558

Semi-Implantable and Fully Implantable Middle Ear Hearing Aids, 7.01.84

Spinal Cord and Dorsal Root Ganglion Stimulation, 7.01.546

Transcatheter Aortic Valve Implantation for Aortic Stenosis, 7.01.132

Treatment of Varicose Veins, 7.01.519

Upper GI Endoscopy, 2.01.533

Medical necessity criteria updated

• Routine preoperative UGI is considered not medically necessary for individuals scheduled for bariatric surgery unless they meet the clinical criteria

Vagus Nerve Stimulation, 7.01.20

Wearable Cardioverter Defibrillators as a Bridge to Implantable Cardioverter-Defibrillator Placement , 2.02.506

Wheelchairs (Manual or Motorized), 1.01.501

Effective January 1, 2021

Pharmacotherapy of Arthropathies, 5.01.550

Medical necessity criteria updated

• Actemra^® (tocilizumab)
  • Treatment of moderate to severe rheumatoid arthritis. Patient must have tried and failed Humira^® (adalimumab) or this drug cannot be tolerated

Pharmacotherapy of Inflammatory Bowel Disorder, 5.01.563

Site of service review added

• Tysabri^® (natalizumab)

Medical necessity criteria updated

• Tysabri^® (natalizumab)
  • Second-line treatment for Crohn’s disease requires trial and treatment failure with corticosteroids, or azathioprine, 6-mercaptopurine, methotrexate, Cimzia^® (certolizumab pegol), Entyvio^® (vedolizumab), Humira^® (adalimumab), Remicade^® (infliximab), or Stelara^® (ustekinumab)

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564

New drug added to policy

• Ilaris^® (canakinumab)
  • Treatment of periodic fever syndromes
  • Treatment of Still’s disease in patients age 2 and older

Pharmacotherapy of Multiple Sclerosis, 5.01.565

Site of service review added

• Tysabri^® (natalizumab)

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523

New drug added to policy

• Tysabri^® (natalizumab)

Use of Granulocyte Colony-Stimulating Factors (G-CSF), 5.01.551

Policy renamed

• From “Granulocyte Colony-Stimulating Factors (G-CSF) Use in Adult Patients” to “Use of Granulocyte Colony-Stimulating Factors (G-CSF)”

Medical necessity criteria updated

• Udenyca^® (pegfilgrastim-cbqv) and Ziextenzo® (pegfilgrastim-bmez)
  • As a first-line treatment for patients under age 18 who are at risk of severe febrile neutropenia
  • As a second-line treatment for patients age 18 or older who are at risk of severe febrile neutropenia when Granix^® (tbo-filgrastim) or Nivestym^® (filgrastim-aafi) has been tried and failed, or there is a medical reason why those two drugs cannot be taken, or there is a valid medical reason why self-injection or home nursing cannot be performed
• Neulasta^® (pegfilgrastim) / Neulasta Onpro^®, Fulphila^® (pegfilgrastim-jmdb), and Nyvepria™ (pegfilgrastim-apgf)
  • As a second-line treatment of patients under age 18 who are at risk of severe febrile neutropenia when Udenyca^® (pegfilgrastim-cbqv) or Ziextenzo^® (pegfilgrastim-bmez) have been tried and failed, or there is a medical reason why those two drugs cannot be taken
  • As a third-line treatment of patients age 18 or older who are at risk of severe febrile neutropenia when Granix^® (tbo-filgrastim) or Nivestym^® (filgrastim-aafi) has been tried and failed, when Udenyca^® (pegfilgrastim-cbqv) or Ziextenzo^® (pegfilgrastim-bmez) has been tried and failed, or there is a medical reason why those drugs cannot be taken

Effective December 3, 2020

Hematopoietic Cell Transplantation for Hodgkin Lymphoma, 8.01.29

Criteria updated

• Tandem autologous hematopoietic cell transplantation (HCT) medical necessity criteria have been removed
• Tandem autologous hematopoietic cell transplantation (HCT) is now considered investigational in patients with Hodgkin lymphoma

Miscellaneous Oncology Drugs, 5.01.540

New drugs added to policy

• Blincyto^® (blinatumomab)
  • Treatment of adults and children for B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD)
  • Treatment of adults and children with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL)
• Leukine^® (sargramostim)
  • Treatment of acute myeloid leukemia after induction chemotherapy
  • Mobilization and following transplant of autologous peripheral blood progenitor cells
  • Myeloid reconstitution after (allogenic or autologous) bone marrow transplant
  • Treatment for bone marrow transplant (allogenic or autologous) failure or engraftment delay
  • Treatment for exposure to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome)

Use of Vascular Endothelial Growth Factor Receptor (VEGF) Inhibitors and Other Angiogenesis Inhibitors in Oncology Treatment, 5.01.517

New drug added to policy

• Cyramza^® (ramucirumab)
  • Treatment of advanced or metastatic gastric or gastro-esophageal junction (GEJ) cancer that has continued to grow while on or after prior fluoropyrimidine- or platinum-containing chemotherapy when used as a single agent or with paclitaxel
  • Treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) gene changes (exon 19 or exon 21) as first-line therapy when used with erlotinib
  • Treatment of metastatic non-small cell lung cancer (NSCLC) that has continued to grow while on or after platinum-based chemotherapy when used with docetaxel
  • Treatment of metastatic colorectal cancer (mCRC) that has continued to grow while on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine when used with a FOLFIRI chemotherapy combination
  • Treatment of hepatocellular carcinoma (HCC) in patients who have an elevated alpha fetoprotein and have been treated with sorafenib when used as a single agent

Revised medical policies

Effective November 1, 2020

Radioimmunotherapy in the Treatment of Non-Hodgkin Lymphoma, 8.01.533

Medical necessity criteria updated

• Patients with mantle cell lymphoma that are ineligible for high-dose therapy may receive a single course of Zevalin^® (ibritumomab tiuxetan)

Investigational criteria updated

• The statement, "Consolidation of a first remission following chemotherapy for de novo aggressive B-cell NHL" has been removed from the policy

New pharmacy policies

Effective November 1, 2020

Selective Estrogen Receptor Modulators and Down Regulators, 5.01.618

New policy

The following brand drugs have been added and may be considered medically necessary when criteria are met:

• Arimidex^® (anastrozole)
  • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer
  • Treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer
  • Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy
  • Treatment of recurrent or metastatic endometrial or uterine cancer
  • Treatment of recurrent ovarian cancer
  • Risk reduction for breast cancer in postmenopausal women
• Aromasin^® (exemestane)
  • Adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two or three years of tamoxifen and are switched to Aromasin® for completion of a total of five consecutive years of adjuvant hormonal therapy
  • Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy
  • Risk reduction for invasive breast cancer in postmenopausal women
• Evista^® (raloxifene)
  • Treatment and prevention of osteoporosis in postmenopausal women
  • Risk reduction for invasive breast cancer in postmenopausal women with osteoporosis
  • Risk reduction for invasive breast cancer in postmenopausal women at high risk for invasive breast cancer
• Fareston^® (toremifene)
  • Treatment of metastatic breast cancer in postmenopausal women with estrogen receptor positive or unknown tumors
• Faslodex^® (fulvestrant)
  • Treatment of HR-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy
  • Treatment of hormone-receptor (HR)-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy
  • Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with ribociclib in postmenopausal women as initial endocrine-based therapy or following disease progression on endocrine therapy
  • Treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression following endocrine therapy
• Femara^® (letrozole)
  • Adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
  • Extended adjuvant treatment of postmenopausal women with early breast cancer who have received prior standard adjuvant tamoxifen therapy
  • Treatment of postmenopausal women with hormone receptor positive or unknown advanced breast cancer
  • Treatment of recurrent ovarian cancer

Revised pharmacy policies

Effective November 1, 2020

Drugs for Rare Diseases, 5.01.576

New drug added to policy

• Keveyis^® (dichlorphenamide)
  • Treatment of periodic paralysis

Erythroid Maturation Agents, 5.01.614

New drug added to policy

• Reblozyl^® (luspatercept-aamt)
  • Treatment of anemia in patients 18 and older who are failing an erythropoiesis stimulating agent (ESA)

Medical Necessity Criteria for Pharmacy Edits, 5.01.605

All drugs listed below may be considered medically necessary when criteria are met.

Alpha Adrenergic Agonists

New drug added to policy

• Upneeq™ (oxymetazoline ophthalmic solution)
  • Treatment of acquired blepharoptosis in patients age 13 and older

Antiparasitic Agents

New policy section

New drugs added to policy

• Daraprim^® (pyrimethamine)
  • Treatment of toxoplasmosis
  • Preventive treatment of toxoplasmosis in patients with HIV
• Generic pyrimethamine
  • Treatment of toxoplasmosis
  • Preventive treatment of toxoplasmosis in patients with HIV

Anticonvulsants

New drugs added to policy

• Aptiom^® (eslicarbazepine)
  • Treatment of partial-onset seizures
• Brand topiramate extended-release capsules
  • Preventive treatment of migraine
  • Treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome
• Briviact^® (brivaracetam)
  • Treatment of partial-onset seizures
• Fycompa^® (perampanel)
  • Treatment of partial-onset seizures
  • Treatment of generalized tonic-clonic seizures
• Nayzilam^® (midazolam nasal spray)
  • Treatment of frequent seizure activity
• Oxtellar XR^® (oxcarbazepine extended-release)
  • Treatment of partial-onset seizures
• Peganone^® (ethotoin)
  • Treatment of tonic-clonic and complex partial seizures
• Qudexy XR^® (topiramate extended-release capsules)
  • Preventive treatment of migraine
  • Treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome
• Spritam^® (levetiracetam tablets for oral suspension)
  • Treatment of partial onset seizures
  • Treatment of myoclonic seizures
  • Treatment of primary generalized tonic-clonic seizures
• Sympazan^® (clobazam oral film)
  • Treatment of seizures associated with Lennox-Gastaut syndrome
• Trokendi XR^® (topiramate extended-release capsules)
  • Preventive treatment of migraine
  • Treatment of partial-onset, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome
• Vimpat^® (lacosamide)
  • Treatment of partial-onset seizures

Brand Oral Antibiotics and Their Generics

New drug added to policy

• Pylera^® (bismuth subcitrate potassium, metronidazole, tetracycline)
  • Treatment of Helicobacter pylori infection and duodenal ulcer disease

Brand Topical Acne or Rosacea Agents

New drug added to policy

• Winlevi^® (clascoterone cream 1%)
  • Treatment of acne

Gastrointestinal Stimulants

New policy section

New drug added to policy

• Gimoti™ (metoclopramide nasal spray)
  • Treatment for symptoms from acute and recurrent diabetic gastroparesis

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Combinations

New drug added to policy

• Brand ketorolac tromethamine nasal spray
  • Treatment of moderate to severe pain

Parkinson's Disease Agents

New drugs added to policy

• Apokyn^® (apomorphine)
  • Intermittent treatment of off episodes
• Kynmobi™ (apomorphine sublingual film)
  • Intermittent treatment of off episodes

Proton Pump Inhibitors

New policy section

New drugs added to policy

• Aciphex^® (rabeprazole)
• Aciphex^® Sprinkle (rabeprazole)
• Dexilant^® (dexlansoprazole)
• Generic omeprazole/sodium bicarbonate
• Nexium^® (esomeprazole)
• Prevacid^® (lansoprazole)
• Prevacid^® Solutab (lansoprazole)
• Prilosec^® (omeprazole)
• Protonix^® (pantoprazole)
• Zegerid^® (omeprazole/sodium bicarbonate)

Miscellaneous Oncology Drugs, 5.01.540

New drugs added to policy

• Inqovi^® (decitabine and cedazuridine)
  • Treatment of adult patients with myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS
• Jakafi^® (ruxolitinib)
  • Treatment of myelofibrosis in adults 18 years of age or older
  • Treatment of polycythemia vera in adults 18 years of age or older
  • Treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older
• Retevmo™ (selpercatinib)
  • Treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC)
  • Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy
  • Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory
• Zepzelca™ (lurbinectedin)
  • Treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy

Medical necessity criteria updated

• Pemazyre™ (pemigatinib) has a dose limit of 13.5 mg once daily for 14 consecutive days followed by 7 days off therapy in 21-day cycles

Pharmacologic Treatment of Duchenne Muscular Dystrophy, 5.01.570

New drug added to policy

• Viltepso™ (vitolarsen)
  • Male patients up to age 10 who have a confirmed diagnosis of Duchenne muscular dystrophy

Medical necessity criteria updated

• Exondys 51^® (eteplirsen)
  • The statement, "Patient has been established on a stable dose of corticosteroids for at least 6 months" has been revised to a duration of 3 months
• Vyondys 53™ (golodirsen)
  • The statement, "Patient has been established on a stable dose of corticosteroids for at least 6 months" has been revised to a duration of 3 months

Pharmacologic Treatment of Sleep Disorders, 5.01.599

New drug added to policy

• Xywav^® (calcium magnesium, potassium, and sodium oxybates)
  • Treatment of cataplexy in narcolepsy in patients 7 years and older
  • Treatment of excessive daytime sleepiness in narcolepsy patients

Pharmacotherapy of Spinal Muscular Atrophy (SMA), 5.01.574

New drug added to policy

• Evrysdi™ (risdiplam)
  • Treatment of spinal muscular atrophy (SMA) in patients age 2 months and older

Added codes

Effective November 1, 2020

Absorbable Nasal Implant for Treatment of Nasal Valve Collapse, 7.01.163
Now requires review for investigative.

C9749

Automated Percutaneous and Percutaneous Endoscopic Discectomy, 7.01.18
Now requires review for investigative.

C2614

Balloon Dilation of the Eustachian Tube, 7.01.158
Now requires review for investigative.

C9745

Bioengineered Skin and Soft Tissues Substitutes, 7.01.582
Now requires review for investigative.

C1849, C9354, C9356, C9358, C9360, C9363, C9364

Interspinous and Interlaminar Stabilization/Distraction Devices (Spacers), 7.01.107
Now requires review for investigative.

C1821

Islet Transplantation, 7.03.12
Now requires review for medical necessity and prior authorization.

0584T, 0585T, 0586T

Keraprosthesis, 9.03.01
Now requires review for medical necessity.

C1818

Microwave Tumor Ablation, 7.01.133
Now requires review for medical necessity.

C9751

Non-covered Services and Procedures, 10.01.517
Now considered non-covered.

C1813, C2622

Phrenic Nerve Stimulation for Central Sleep Apnea, 2.02.33
Now requires review for investigative.

C1823

Total Artificial Hearts and Implantable Ventricular Assist Devices, 7.03.11
Now requires review for medical necessity and prior authorization.

33981, 33982, 33983

Total Artificial Hearts and Implantable Ventricular Assist Devices, 7.03.11
Now requires review for investigative.

33990, 33991, 33992, 33993

Sinus Surgery, 7.01.559
Now requires review for medical necessity and prior authorization.

C1726

Surgical Treatment of Snoring and Obstructive Sleep Apnea Syndrome, 7.01.101
Now requires review for medical necessity.

C9727

Effective February 5, 2021

InterQual® Criteria: Services Reviewed for Medical Necessity, 10.01.531

This policy is updated to remove reference to services replaced with individual policies that address medical procedures and durable medical equipment. See the Special notices (above) under the Updates for non-individual and individual plans for the specific policies.

No updates this month

Effective February 5, 2021

Services Reviewed Using InterQual® Criteria, 10.01.530

This policy is updated to remove reference to services replaced with individual policies that address medical procedures and durable medical equipment. See the Special notices (above) under the Updates for non-individual and individual plans for the specific policies.

No updates this month