MP/CG Update/Notice - August 2022 Form

P.O. Box 4330 Woodland Hills, CA 91365 CABC-CM-003455-22

Anthem Blue Cross is the trade name of Blue Cross of California. Anthem Blue Cross and Anthem Blue Cross Life and Health Insurance Company are independent licensees of the Blue Cross Association. Anthem is a registered trademark of Anthem Insurance Companies, Inc.

August 1, 2022

Dear Provider:

Anthem Blue Cross is pleased to provide you with our new and updated Medical Policies and Clinical UM Guidelines.
Please refer to the specific policy for coding, language, rationale updates and changes that are not summarized below.

To view medical policies and utilization management guidelines applicable to members enrolled in the Blue Cross and Blue Shield Service Benefit Plan, commonly referred to as the Federal Employee Program® (FEP®), please visit www.fepblue.org > Policies & Guidelines.

Updates to AIM Specialty Health® (AIM) programs, a separate company, apply to local fully-insured Anthem members and select members who are covered under self-insured (ASO) benefit plans with services medically managed by AIM. They do not apply to HMO, BlueCard®, Medicare Advantage, Medicaid, Medicare Supplement, or Federal Employee Program® (FEP®). For more information, please contact the phone number of the back of the member ID card.

NEW Medical Policies effective November 1, 2022

• DME.00046 Intermittent Abdominal Pressure Ventilation Devices: This document addresses the use of intermittent abdominal pressure ventilation devices. o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required effective November 1, 2022

• DME.00047 Rehabilitative Devices with Remote Monitoring: This document addresses the use of rehabilitative devices with remote monitoring and adjustment capabilities intended to evaluate and improve muscle strength and range of motion while reporting session data to the individual’s provider. o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required effective November 1, 2022

• DME.00048 Virtual Reality-Assisted Therapy Systems: This document addresses the use of virtual reality- assisted therapy systems that may be used in the management of pain, cognitive or motor rehabilitation, treatment of procedural anxiety, and promotion of weight control. o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required effective November 1, 2022

• GENE.00059 Hybrid Personalized Molecular Residual Disease Testing for Cancer: This document addresses hybrid personalized molecular residual disease (MRD) testing for oncologic disease management. o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required except for Stage 3 or 4 cancer diagnoses effective November 1, 2022 o Select accounts are managed by AIM

• LAB.00048 Pain Management Biomarker Analysis: This document addresses a new pain biomarker test, the Foundation Pain Index (FPI), which is a test panel of pain functional biomarkers in urine and is intended to identify sources of chronic pain. o Considered Investigational and Not Medically Necessary for chronic pain management and for all other indications o Prior authorization required effective November 1, 2022

• MED.00139 Electrical Impedance Scanning for Cancer Detection: This document addresses the use of electrical impedance scanning for cancer detection. o Considered Investigational and Not Medically Necessary for all indications o Prior authorization required effective November 1, 2022

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• TRANS.00039 Portable Normothermic Organ Perfusion Systems: This document addresses use of a portable normothermic organ machine perfusion and monitoring medical device used to preserve donor organs in a near- normothermic state from retrieval until transplantation. o Outlines the Medically Necessary and Investigational and Not Medically Necessary criteria

UPDATED Clinical Guideline and Medical Policy effective November 1, 2022

• CG-SURG-61 Cryosurgical, Radiofrequency or Laser Ablation to Treat Solid Tumors Outside the Liver: This document focuses on the use of cryosurgical (also known as cryosurgery or cryoablation), radiofrequency or laser ablation as a treatment of primary or secondary malignancies outside the liver; and benign tumors outside the liver. o Revised title (previous title: Cryosurgical or Radiofrequency Ablation to Treat Solid Tumors Outside the Liver) o Removed the reference to glomerular filtration rate from the radiofrequency and cryosurgical ablation treatment of renal cancer o Added the term “metastatic” to the radiofrequency ablation treatment of metastatic lung cancer to clarify extra-pulmonary disease o Added Not Medically Necessary statement for laser ablation therapy o Removed examples from the cryosurgical and radiofrequency ablation Not Medically Necessary statements

• GENE.00023 Gene Expression Profiling of Melanomas and Cutaneous Squamous Cell Carcinoma: This document addresses gene expression profiling to assist in determining the diagnosis, risk stratification and clinical management of cutaneous and uveal (ocular) melanoma and cutaneous squamous cell carcinoma. o Revised title (previous title: Gene Expression Profiling of Melanomas) o Expanded Scope and Position Statement to include cutaneous squamous cell carcinoma

Medical Policies archived

• DME.00024 Transtympanic Micropressure (effective July 6, 2022) • DME.00039 Prefabricated Oral Appliances for the Treatment of Obstructive Sleep Apnea (effective September 12, 2022) • MED.00121 Implantable Interstitial Glucose Monitors (effective June 29, 2022) • SURG.00101 Suprachoroidal Injection of a Pharmacologic Agent (effective May 19, 2022) • SURG.00137 Focused Microwave Thermotherapy for Breast Cancer (effective July 6, 2022)

Medical Policy converted to Clinical UM Guideline effective July 6, 2022

Medical Policy Title Clinical UM Guideline MED.00127 Chelation Therapy CG-MED-90

Clinical Guideline de-adopted effective August 1, 2022

• CG-MED-76 Magnetic Source Imaging and Magnetoencephalography

Specialty Pharmacy Updates

Effective for dates of service on and after November 1, 2022, the following specialty pharmacy codes from current or new clinical criteria documents will be included in our prior authorization review process.

Anthem’s medical specialty drug review team manages prior authorization clinical review of non-oncology use of specialty pharmacy drugs. Review of specialty pharmacy drugs for oncology use is managed by AIM Specialty Health® (AIM), a separate company.

Clinical Criteria is available at www.anthem.com/ca/ms/pharmacyinformation/clinicalcriteria.html

Important to note: Currently, your patients may be receiving these medications without prior authorization. Effective November 1, 2022, you may be required to request prior authorization review for your patients’ continued use of these medications.

Inclusion of National Drug Code (NDC) on your claim will help expedite claim processing of drugs billed with a Not Otherwise Classified (NOC) code.

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Clinical Criteria Drug HCPCS Code(s) ING-CC-0002 Releuko (filgrastim-ayow) C9096 ING-CC-0072 Alymsys (bevacizumab-maly) C9399, J3490, J3590, J9999 ING-CC-0107 Alymsys (bevacizumab-maly) C9399, J3490, J3590, J9999 ING-CC-0118 Pluvicto (lutetium lu 177 vipivotide tetraxetan) A9699 ING-CC-0216 Opdualag (nivolumab and relatlimab-rmbw) C9399, J3490, J3590, J9999

• Oncology use is managed by AIM.

  Prior authorization requests for certain medications may require additional documentation to determine medical necessity.

  Step therapy updates

  Effective for dates of service on and after November 1, 2022, the following specialty pharmacy codes from current clinical criteria documents will be included in our specialty pharmacy medical step therapy review process.

  Clinical Criteria Status Drug HCPCS or CPT Code(s) ING-CC-0107 Non-preferred Alymsys C9399, J3490, J3590, J9999 ING-CC-0002 Non-preferred Releuko C9096 *Oncology use is managed by AIM.

  Courtesy Notice Effective for dates of service on and after October 1, 2022, updated step therapy criteria for immunoglobulins found in clinical criteria document ING-CC-0003 will be implemented. The preferred product list is being expanded.
  Please refer to clinical criteria document for details.

  Quantity limit updates

  Effective for dates of service on and after November 1, 2022, the following specialty pharmacy codes from current clinical criteria documents will be included in our quantity limit review process.

  Clinical Criteria Drug HCPCS or CPT Code(s) ING-CC-0072 Alymsys (bevacizumab-maly) C9399, J3490, J3590

  The complete list of our Medical Policies and Clinical UM Guidelines may be accessed on the Anthem Blue Cross Web site at http://www.anthem.com/ca and then selecting “For Providers”, then selecting “Policies, Guidelines & Manuals” under the Provider Resources column, select “Change State” and choose California, scrolling down to select “View Medical Policies & Clinical UM Guidelines”, then selecting ”Full List page” or by entering a keyword or code in the search box.

  We thank you for your continued efforts on behalf of our members and your partnership toward improved access to quality health care for Californians.

  Sincerely,

  John Yao, MD, MPH, MBA, MPP, FACP Chief Medical Officer

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Attachment A – Revised Medical Policies and Clinical Guidelines Policy/Guideline Number Title Medical Policy / Clinical Guideline Changes CG-GENE-14 (AIM Genetic Testing) Gene Mutation Testing for Cancer Susceptibility and Management • Updated descriptor for CPT code 0229U CG-GENE-22 (AIM Genetic Testing) Gene Expression Profiling for Managing Breast Cancer Treatment • Combined three Medically Necessary statements into one statement • Added criterion F on tumor size in section II of Medically Necessary statement • Changed criterion C to ‘the individual is a candidate for additional cancer therapy’ in section III of the Medically Necessary statement • Added ‘including but not limited to in individuals with known metastatic cancer’ in the first Not Medically Necessary statement • Changed formatting of list in last Not Medically Necessary statement CG-DME-49 Standing Frames • Added Medically Necessary and Not Medically Necessary statements for replacement of non-powered standing frames CG-SURG-71 Reduction Mammaplasty • Revised bullet points in sections I and II of the Medically Necessary statement related to pain and other diagnoses • Added a Note on medical records following section II in Medically Necessary statement CG-SURG-95 Sacral Nerve Stimulation and Percutaneous Tibial Nerve Stimulation for Urinary and Fecal Incontinence; Urinary Retention • In the Sacral Nerve Stimulation (SNS) for Fecal Incontinence section, removed requirement for 12-month history of symptoms post vaginal delivery and clarified Note in that section • Added criteria for when replacements and revisions to SNS devices are Medically Necessary ANC.00007 Cosmetic and Reconstructive Services: Skin Related • Revised the Position Statement under Hair Procedures to remove reference to gender-specific alopecia and removed example ANC.00009 Cosmetic and Reconstructive Services of the Trunk and Groin • References updated DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices • Added CPT code 0720T effective July 1, 2022, for
percutaneous electrical nerve field stimulation device; considered Investigational and Not Medically Necessary DME.00030 Altered Auditory Feedback Devices for Fluency Disorders • Revised title (previous title: Altered Auditory Feedback Devices for the Treatment of Stuttering) • Revised the Position Statement to replace the term "stuttering" with ”fluency disorders” GENE.00049 Circulating Tumor DNA Panel Testing (Liquid Biopsy) • Added CPT PLA code 0326U effective July 1, 2022, for Guardant360 panel; considered Investigational and Not Medically Necessary GENE.00052 Whole Genome Sequencing, Whole Exome Sequencing, Gene Panels, and Molecular Profiling • Added CPT PLA code 0329U for Oncomap test having Medically Necessary criteria, and CPT PLA code 0331U for genome mapping test considered Investigational and Not Medically Necessary; both codes effective July 1, 2022, GENE.00053 Metagenomic Sequencing for Infectious Disease in the Outpatient Setting • Added CPT PLA code 0323U effective July 1, 2022, for metagenomic next generation sequencing assay; considered Investigational and Not Medically Necessary

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LAB.00003 In Vitro Chemosensitivity Assays and In Vitro Chemoresistance Assays • Added CPT PLA codes 0324U, 0325U effective July 1, 2022, for ovarian tumor drug response panels, considered Not Medically Necessary LAB.00019 Proprietary Algorithms for Liver Fibrosis in the Evaluation and Monitoring of Chronic Liver • Updated descriptor for CPT code 0166U LAB.00027 Selected Blood, Serum and Cellular Allergy and Toxicity Tests • Added existing CPT code 83520, considered Investigational and Not Medically Necessary for food allergy diagnoses LAB.00029 Rupture of Membranes Testing in Pregnancy • Revised position statement from Investigational and Not Medically Necessary to Not Medically Necessary MED.00132 Adipose-derived Regenerative Cell Therapy and Soft Tissue Augmentation Procedures • Added CPT codes 0717T, 0718T effective July 1, 2022, for autologous adipose-derived regenerative cell therapy for rotator cuff tear; considered Investigational and Not Medically Necessary OR-PR.00003 Microprocessor Controlled Lower Limb Prosthesis • Revised language throughout document to replace the term “amputee” SURG.00011 Allogeneic, Xenographic, Synthetic, Bioengineered, and Composite Products for Wound Healing and Soft Tissue Grafting • Revised Investigational and Not Medically Necessary statement to Not Medically Necessary for products with Medically Necessary indications SURG.00037 Treatment of Varicose Veins (Lower Extremities) • Revised Investigational and Not Medically Necessary indications to Not Medically Necessary indications for endoluminal ablation, endoluminal cryoablation, mechanochemical ablation, sclerotherapy and coil embolization SURG.00097 Scoliosis Surgery • Added Medically Necessary criteria for vertebral body tethering SURG.00143 Perirectal Spacers for Use During Prostate Radiotherapy • Revised Medically Necessary Position Statement to clarify criteria without a change in intent SURG.00145 Mechanical Circulatory Assist Devices (Ventricular Assist Devices, Percutaneous Ventricular Assist Devices and Artificial Hearts) • Converted Investigational and Not Medically Necessary
statements to Not Medically Necessary statements • Removed Investigational and Not Medically Necessary
statements for use of non-FDA approved or cleared devices • Moved Not Medically Necessary contraindication information to background section of document with relevant devices SURG.00160 Implanted Port Delivery Systems to Treat Ocular Disease • Added HCPCS code J2779 effective July 1, 2022, for SUSVIMO, considered Investigational and Not Medically Necessary; replacing C9093 deleted June 30, 2022, and not otherwise classified codes J3490, J3590