Medical Policy and Coding Updates July 2022

Effective September 11, 2022

Updates to AIM Specialty Health® Clinical Appropriateness Guidelines

Effective for dates of service on and after September 11, 2022, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Advanced Imaging

Updates by section

Extremity Imaging

Fracture

• Added indication for evaluation of supracondylar fracture
• Added CT as an alternative to MRI for tibial plateau fracture

General information/overview

• Allowed exception to specified durations of conservative management in rare cases

Perioperative imaging (including delayed hardware failure), not otherwise specified

• Added statement that advanced imaging is not indicated for robotic-assisted hip arthroplasty

Rotator cuff tear

• Updated conservative management time from 4 weeks to 6 weeks for rotator cuff tear

Shoulder arthroplasty

• Added statement that advanced imaging is not indicated for robotic-assisted shoulder arthroplasty

Spine Imaging

Cervical injury

• Clarified that post-traumatic neurologic deficit refers specifically to an exam finding

General information/overview

• Allowed exception to specified durations of conservative management in rare cases

Perioperative and periprocedural imaging

• Added requirement for initial evaluation with radiographs

Thoracic or lumbar injury

• Clarified that neurologic deficit refers specifically to an exam finding

Vascular Imaging: Brain, Head and Neck

Pulsatile tinnitus

• Added optional CTA/MRA neck evaluation for pulsatile tinnitus

Stenosis or occlusion, extracranial carotid arteries

• Added new screening indications for post-neck irradiation and incidental carotid calcification
• Revised surveillance guidelines to align with Society for Vascular Surgery for annual imaging, post-revascularization after first year

Stroke or transient ischemic attach (TIA)

• Divided this section into two categories: intracranial evaluation and extracranial evaluation
• Revised guidelines to align with American Hospital Association/American Society of Anesthesiologists
  • Allowed CTA/MRA of the neck without previous prerequisite for subacute stroke/TIA
• Allowed CTA/MRA for chronic posterior circulation stroke/TIA
• Added indication for carotid ultrasound

Vascular Imaging: Abdomen and Pelvis

Acute aortic syndrome

• Added optional pelvic imaging

Aneurysm of the abdominal aorta or iliac arteries

• Screening: Added femoral aneurysm to the list of lower extremity sites
• Management: Revised guidelines to align with Society for Vascular Surgery for post-endovascular repair to repeat imaging 12 months after baseline
• Surveillance: Revised guidelines to align with Society for Vascular Surgery for stable aneurysms treated with endographs
  • Duplex arterial ultrasound annually
  • CT every 5 years

Venous thrombosis or occlusion

• Added optional pelvic imaging to Imaging Study section

Vascular Imaging: Upper Extremity

Peripheral arterial disease (PAD)

• Added any sign or symptom with inconclusive physiologic testing, including exercise testing, to diagnostic criteria for suspected PAD and management of known PAD
• Added criteria for the management of PAD: resting ischemic pain to unilateral cold painful hand

Vascular Imaging: Lower Extremity

Peripheral arterial disease (PAD)

• Added any sign or symptom with inconclusive physiologic testing, including exercise testing, to diagnostic criteria for suspected PAD
• Revised guidelines to align with Society for Vascular Surgery by adding indication for ultrasound surveillance for repaired popliteal artery aneurysm

Effective for dates of service on and after September 11, 2022, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Sleep Disorder Management.

Updates by section

Sleep Disorder Diagnostic Management

Established sleep disorder (OSA or other) - follow-up laboratory studies

• Added option that a follow-up, in-lab sleep study may be allowed to adjust device settings after insertion of a hypoglossal nerve stimulator

Multiple sleep latency testing (MSLT) and/or maintenance of wakefulness testing (MWT)

• Added MWT indication for occupational safety  

Sleep Disorder Treatment Management

Management of obstructive sleep apnea using oral appliances

• Added age indication for patients age 16 years and older to the use of a custom fabricated oral appliance

Effective September 4, 2022

Updates to AIM Specialty Health® Clinical Appropriateness Guidelines

Effective for dates of service on and after September 4, 2022, the following updates will apply to the AIM Specialty Health® Clinical Appropriateness Guidelines for Genetic Testing

Updates by section

Hereditary Cardiac Disease

Appropriate use criteria

• Added general genetic testing criteria

Genetic testing of affected individuals

• Moved content with specific cardiac conditions in "Testing of Asymptomatic Individuals" to this section

Genetic testing in the evaluation of sudden cardiac arrest

• Added this new section and medical necessity criteria

Post-mortem genetic testing

• Added new medical necessity criteria

Reproductive Carrier Screening and Prenatal Diagnosis

Preimplantation genetic testing of embryos

• Added polygenetic risk scores (PRS) to the list of not medically necessary conditions

Single Gene and Multifactoral Conditions

Thrombophilia testing

• Removed the criterion for an individual with unprovoked venous thromboembolism

Somatic and Hematologic Tumors Genetic Testing

Conditions for which testing may be medically necessary

• Added FoundationOne® as medically necessary for non-small cell lung cancer (NSCLC) stage IIIB and above
• Added targeted multigene panels as medically necessary for endometrial cancer

Cell-free testing

• Listed ctDx Lung™ and Target Selector™ NGS Lung Panel as the only approved targeted multi-gene panels for biomarkers in locally advanced or metastatic non-small cell lung cancer (NSCLC)

Cancer screening

• Added timing of PSA testing in relation to the PCA3 or ConfirmMDx test  
• Moved criteria for gene expression classifier testing for indeterminate thyroid nodules (ITN) from Table 1 to this section

Effective September 2, 2022

Cervical Spine Surgeries: Discectomy, Laminectomy, and Fusion in Adults, 7.01.560

Anterior cervical fusion
Indications added

• Spine fracture and/or dislocation
• Cervical spine revision surgery  

Medical necessity criteria updated
Indication: Cervical pseudoarthritis

• Cervical pseudarthrosis must be symptomatic
• Imaging shows evidence of hardware failure
• Pain aligns with the level of pseudoarthritis
• A cervical spine MRI or CT scan 12 months after a previous spinal fusion shows non-union at the same level as symptom/exam findings

Posterior cervical fusion

Indication added

• Implant/instrumentation failure

Medical necessity criteria updated
Indication:  Cervical pseudoarthritis

• Imaging shows evidence of hardware failure
• Pain aligns with the level of pseudoarthritis
• A cervical spine MRI or CT scan 12 months after a previous spinal fusion shows non-union at the same level as symptom/exam findings 

Hysterectomy for Non-Malignant Conditions, 7.01.548

Medical necessity criteria updated
Criteria for uterine fibroids has been separated from the abnormal uterine bleeding indication 

Indications added

• Chronic pelvic inflammatory disease (PID)
• Pelvic pain

Lumbar Spinal Fusion in Adults, 7.01.542

Indication added
Revision surgery for implant/instrumentation failure

Spravato® (esketamine) Nasal Spray, 5.01.609

All Indications
Medical necessity criteria updated

• Documentation of depression must include the patient's symptoms and their severity as measured by one or more standardized depression rating scales
• The patient must have no current use of any mind- or mood-altering substances, including but not limited to alcohol, marijuana, stimulants, and hallucinogens/psychedelics

All Indications
Medical necessity criteria added
A new course of Spravato® treatment when the patient was previously treated with this drug

All Indications
Re-authorization criteria updated

• The patient must not have a current substance use disorder, unless there has been complete abstinence for a month
• The patient must have no current use of any mind- or mood-altering substances, including but not limited to alcohol, marijuana, stimulants, and hallucinogens/psychedelics

Upper Gastrointestinal (UGI) Endoscopy for Adults, 2.01.533

Medical necessity criteria updated

• The timing of persistent GERD symptoms following treatment with daily proton pump inhibitor (PPI) therapy has been changed from 4 - 8 weeks to 8 weeks
• Criterion added that UGI may be performed to evaluate returning GERD or heartburn symptoms after the completion of proton pump inhibitor (PPI) treatment
• Deleted criterion that a UGI may be performed after 6-12 weeks of treatment with a histamine H2-receptor antagonist
• Follow-up of known eosinophilic esophagitis has been added to the list of medically necessary conditions

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

Medical necessity criteria updated
A 90-day time limit has been added for the use of a wearable cardioverter-defibrillator as a bridge to a permanent implantable (internal) cardioverter-defibrillator surgery

Effective August 5, 2022

Drugs for Rare Diseases, 5.01.576

Pompe Disease
Site of service review added

• Nexviazyme™ (avalglucosidase alfa-ngpt) IV

Thyroid Eye Disease (TED)
Medical necessity criteria updated

• Tepezza™ (teprotumumab-trbw)
  • The patient must have tried glucocorticoids before this drug can be prescribed
  • This drug will be given within 9 months of completing the glucocorticoid trial
  • This drug must be prescribed by an ophthalmologist with expertise in TED treatment or endocrinologist with expertise in TED treatment
  • This drug is not being used in combination with another biologic drug that can be used to treat TED

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523

Site of service review added

• Nexviazyme™ (avalglucosidase alfa-ngpt) IV

Effective July 7, 2022

Immune Checkpoint Inhibitors, 5.01.591

Site of service review added

• Keytruda® (pembrolizumab)
• Opdivo® (nivolumab)

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523

Site of service review added

• Keytruda® (pembrolizumab)
• Opdivo® (nivolumab)

Effective July 1, 2022

For dates of service on or after July 1, 2022, Premera will no longer review home sleep studies for prior authorization and medical necessity. Providers will no longer need to submit a request through AIM Specialty Health® for these services. AIM Specialty Health® will still review supplies/equipment and in lab sleep studies.

New medical policies
Effective July 1, 2022

Intra-articular Hyaluronan Injections for Osteoarthritis, 2.01.534

Policy renumbered

• This policy replaces Intra-articular Hyaluronan Injections for Osteoarthritis, 2.01.31
• All other policy statements remain unchanged

Uterus Transplantation for Absolute Uterine Factor Infertility, 4.02.06

New policy
Uterus transplantation for absolute uterine factor infertility is considered investigational

Revised medical policies
Effective July 1, 2022

Gender Transition/Affirmation Surgery and Related Services, 7.01.557

Policy renamed
From "Gender Transition/Affirmation Surgery" to "Gender Transition/Affirmation Surgery and Related Services"

All sections
Medical necessity criteria updated

• For mental health recommendation letters, revised "psychotherapy monthly or more frequently" to "psychotherapy or mental health treatment." Removed the "monthly or more frequently" requirement
• For pre-surgery evaluation, added no documentation of any necessary medical evaluations or treatment or clearance prior to surgery, or of any healthcare action that is necessary prior to surgery
• Added note that if hormone treatment has resulted in breast growth greater than a young adolescent stage of development, then initial male to female augmentation mammoplasty can be considered for coverage as a feminization procedure if the member's plan has coverage for such procedures

Standard benefit coverage
Mastectomy or breast reduction
Note added

• Added a note that mastectomy or additional breast reduction after initial breast reduction surgery is considered to be a new procedure, not the second stage of breast/chest surgery or revision of the initial surgery

Expanded benefit coverage
Non-breast/chest surgeries and procedures
Non-genital surgeries
Additional breast augmentation, and breast/chest or genital cosmetic procedures
Medical necessity criteria updated

• Criteria for mental health recommendation letters and for pre-surgery evaluations by the surgeon now cover both prospective and retrospective requests
• For hair removal, which is not surgery, the pre-procedure evaluation is by a referring medical provider or the hair removal provider

Coverage of changes or modifications to previous surgery
Correction or repair of complications
Revisions due to complications
Reversal and redoing due to complications
Medical necessity criteria updated

• Added "if the complication is causing or is likely to cause a medical or surgical emergency" for correcting complications of surgery that was done under a non-Company plan

Recommendations by licensed mental health professionals
Medical necessity criteria updated

• Added criteria for when mental health recommendations could be from clinicians who are not licensed to practice independently
• Removed criterion that letters written by trainees or by clinicians requiring supervision and co-signed by supervising clinicians are not acceptable
• Added meeting Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for Gender Dysphoria as an alternative for documenting current gender dysphoria symptoms
• Added criterion that if psychiatric medication is being taken for treatment of any psychiatric symptoms or disorders, the letters must verify or demonstrate that such symptoms or disorders are reasonably well-controlled and are not contraindications to surgery
• Added requirements for updated or new pre-surgery surgeon evaluations when authorized surgery is not done within six months, or when significantly different procedures are spaced-out over time

Documentation requirements
Policy statement added

• All specific medical necessity criteria should be documented
• A general statement in the patient's medical record that World Professional Association for Transgender Health (WPATH) criteria or standards are met is not sufficient

Prescription Digital Therapeutics, 13.01.500
Investigational criteria updated
RelieVRx™ for the treatment of chronic low back pain has been added to the list of investigational prescription digital therapeutics

New pharmacy policies

No updates this month

Revised pharmacy policies
Effective July 1, 2022

C3 and C5 Complement Inhibitors, 5.01.571

Drug with new indication

• Ultomiris® (ravulizumab-cwvz)
  • Treatment of adult patients with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive

Folate Antimetabolites, 5.01.617

Drug with new indication

• Alimta® (pemetrexed)
  • Use in combination with pembrolizumab and platinum chemotherapy for the treatment of patients with metastatic non-squamous NSCLC with EGFR or ALK/ROS1 genomic mutations who have disease progression on FDA approved therapy for these mutations

Medical necessity criteria updated

• Alimta® (pemetrexed)
  • Specified the use as the initial "chemotherapy" treatment when used in combination with platinum chemotherapy for non-squamous NSCLC and when used in combination with cisplatin for malignant pleural mesothelioma

Note added

• Alimta® (pemetrexed)
  • Prior use of targeted therapies or immunotherapies are not chemotherapy treatments

Herceptin® (trastuzumab) and Other HER2 Inhibitors, 5.01.514

Drug moved to first-line treatment

• Ogivri™ (trastuzumab-dkst)

Medical necessity criteria updated

• Herzuma® (trastuzumab-pkrb)
• Kanjinti™ (trastuzumab-anns)
• Ontruzant® (trastuzumab-dttb)
  • The patient must have tried and failed Herceptin® (trastuzumab), or Ogivri™ (trastuzumab-dkst), or Trazimera™ (trastuzumab-qyyp) before the above drugs can be prescribed 

Medical necessity criteria updated

• Enhertu® (fam-trastuzumab deruxtecan-nxki)
  • For the treatment of metastatic breast cancer, this drug may also be used before or after primary treatment

Drug added

• Herzuma® (trastuzumab-pkrb)
  • Treatment of metastatic gastric cancer

Note added

• Phesgo™ (pertuzumab, trastuzumab, and hyaluronidase-zzxf)
  • Switching therapy from Perjeta® (pertuzumab) and/or a trastuzumab product to Phesgo™ during treatment is allowed

Miscellaneous Oncology Drugs, 5.01.540

Drug removed

• Piqray® (alpelisib)
  • This drug has been moved to policy Phosphoinositide 3-kinase (PI3K) Inhibitors, 5.01.592, with no changes to coverage criteria

Drugs with new indications

• Darzalex® (daratumumab)
  • Use in combination with carfilzomib and dexamethasone in patients with multiple myeloma that has relapsed or has not responded to treatment and who have received one to three prior lines of therapy
• Leukine® (sargramostim)
  • Second-line therapy for the treatment of patients taking myelosuppressive anti-cancer regimens who are at risk of severe febrile neutropenia
• Tibsovo® (ivosidenib)
  • Use in combination with azacitidine or alone for the treatment of newly diagnosed acute myeloid leukemia (AML)

Medical Necessity Criteria for Pharmacy Edits, 5.01.605

Alpha Adrenergic Agonist

Drug added

• Igalmi™ (dexmedetomidine sublingual film)
  • Treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults age 18 years and older

Antiprotozoal Agents

Drug added

• Impavido® (miltefosine)

Brand Oral Antibiotics and Their Generics

Drug added

• Lymepak™ (doxycycline)

Brand Topical Acne or Rosacea Products

Drug added

• Epsolay® (benzoyl peroxide cream)
  • Treatment of inflammatory lesions of rosacea

Chelating Agents

Drug added

• Cuvrior® (trientine tetrahydrochloride)
  • Treatment of adult patients age 18 years and older with stable Wilson's disease

Heart Failure Agents

Drug added

• Camzyos™ (mavacamten)
  • Treatment of symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy (HCM)

Muscle Relaxants

Drug added

• Fleqsuvy™ (baclofen oral solution)

Testosterone Replacement Products

Drug added

• Tlando™ (testosterone capsules)

Monoclonal Antibodies for the Treatment of Lymphoma, 2.03.502

Drug moved to first-line treatment

• Truxima® (rituximab-abbs)

Medical necessity criteria updated

• Riabni™ (rituximab-arrx)
  • The patient must have tried and failed Rituxan® (rituximab), or Ruxience™ (rituximab-pvvr), or Truxima® (rituximab-abbs)

Pharmacologic Prevention and Treatment of HIV/AIDS, 5.01.588

Policy renamed

From "Pharmacologic Treatment of HIV/AIDS" to "Pharmacologic Prevention and Treatment of HIV/AIDS"

Drug added

• Apretude (cabotegravir extended-release injectable suspension)
  • Pre-exposure prevention to reduce the risk of HIV-1 infection in patients age 13 years and older

Rituximab: Non-oncologic and Miscellaneous Uses, 5.01.556

Drug moved to first-line treatment

• Truxima® (rituximab-abbs)

Medical necessity criteria updated

• Riabni™ (rituximab-arrx)
  • The patient must have tried and failed Rituxan® (rituximab), or Ruxience™ (rituximab-pvvr), or Truxima® (rituximab-abbs)

Medical necessity criteria updated

• Rituxan® (rituximab) 
• Ruxience™ (rituximab-pvvr)
• Truxima® (rituximab-abbs)
  • For autoimmune hemolytic anemias (AIHA), the criterion for treatment of cold agglutination syndrome has been revised to cold agglutinin disease

An archived policy is one that’s no longer active and is not used for reviews.

Effective July 1, 2022

7.01.568 Designated Centers of Excellence: Total Knee or Total Hip Replacement

• For dates of service beginning July 1, 2022 and after, providers will need to use medical necessity criteria in these two policies: Hip Arthroplasty in Adults, 7.01.573, and Knee Arthroplasty in Adults, 7.01.550

Effective July 1, 2022

Intra-articular Hyaluronan Injections for Osteoarthritis, 2.01.31

This policy has been replaced by Intra-articular Hyaluronan Injections for Osteoarthritis, 2.01.534

Added codes

Effective July 1, 2022

Amniotic Membrane and Amniotic Fluid, 7.01.583

Now requires review for investigational.

Q4259, Q4260, Q4261

Drugs for Rare Diseases, 5.01.576

Now requires review for medical necessity.

C9094

Drugs for Rare Diseases, 5.01.576

Now requires review for medical necessity and prior authorization.

J2998

Electrical Stimulation Devices, 1.01.507

Now requires review for investigational.

0720T

Immune Globulin Therapy, 8.01.503

Now requires review for medical necessity and prior authorization.

J1551

Intravitreal and Suprachoroidal Corticosteroids, 5.01.619

Now requires review for medical necessity and prior authorization.

J3299

Miscellaneous Oncology Drugs, 5.01.540

Now requires review for medical necessity.

C9095

mTOR Kinase Inhibitors, 5.01.533

Now requires review for medical necessity and prior authorization.

J9331

Non-covered Experimental/Investigational Services, 10.01.533

Now requires review for investigational.

0721T, 0722T, 0723T, 0724T, 0731T, 0732T, 0733T, 0734T, 0736T, 0737T

Pharmacologic Prevention and Treatment of HIV/AIDS, 5.01.588

Now requires review for medical necessity and prior authorization.

J0739

Pharmacologic Treatment of High Cholesterol, 5.01.558

Now requires review for medical necessity and prior authorization.

J1306

Pharmacotherapy of Miscellaneous Autoimmune Diseases, 5.01.564

Now requires review for medical necessity and prior authorization.

J9332

Thymic Stromal Lymphopoietin (TSLP) Inhibitors, 5.01.627

Now requires review for medical necessity and prior authorization.

J2356

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

Now requires review for medical necessity.

C9096

Uterus Transplantation for Absolute Uterine Factor Infertility, 4.02.06

Now requires review for investigational.

0664T, 0665T, 0666T, 0667T, 0668T, 0669T, 0670T

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620

Now requires review for medical necessity.

C9097

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620

Now requires review for medical necessity and prior authorization.

J2779

AIM Specialty Health® Sleep Disorder Management

Now reviewed by AIM® Specialty Health and requires prior authorization.

0326U, 0327U, 0329U, 0331U

Revised codes
Effective July 1, 2022

Site of Service: Infusion Drugs and Biologic Agents, 11.01.523

Now requires review for medical necessity, including site of service and prior authorization.

J9271, J9299

Removed codes
Effective July 1, 2022

mTOR Kinase Inhibitors, 5.01.533

No longer requires review for medical necessity.

C9091

Drugs for Rare Diseases, 5.01.576

No longer requires review for medical necessity.

C9090

Intravitreal and Suprachoroidal Corticosteroids, 5.01.619

No longer requires review for medical necessity.

C9092

Vascular Endothelial Growth Factor (VEGF) Receptor Inhibitors for Ocular Disorders, 5.01.620

No longer requires review for medical necessity.

C9093

Gender Transition/Affirmation Surgery and Related Services, 7.01.557

No longer requires review for medical necessity and prior authorization.

11960

AIM Specialty Health® Sleep Disorder Management

No longer requires review. Code terminated.

95800, 95801, 95806, G0398, G0399, G0400

Removed codes
Effective July 1, 2022

Glaucoma, Invasive Procedures, 9.03.510

No longer requires review for medical necessity.

0191T, 0253T