Coverage and Clinical Guidelines update (effective January 1, 2025)

Effective January 1, 2025, Anthem Blue Cross and Blue Shield and its affiliate HealthKeepers, Inc. will implement the following new and revised Coverage Guidelines. These guidelines will not impact Federal Employee Program^® (FEP) members. These guidelines were among those recently approved at the Medical Policy and Technology Assessment Committee meeting held on August 8, 2024.

The guidelines addressed in this edition of Provider News are:

• DME.00011 Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous Devices
• DME.00052 Brain Computer Interface Rehabilitation Devices
• LAB.00026 Systems Pathology and Multimodal Artificial Intelligence Testing for Cancerous and Precancerous Conditions
• LAB.00051 Per- and Polyfluoroalkyl Substances (PFAS) Testing
• MED.00134 Non-invasive Heart Failure and Arrhythmia Management and Monitoring Systems
• MED.00150 Hepzato Kit™ (melphalan hepatic delivery system)
• SURG.00032 Patent Foramen Ovale and Left Atrial Appendage Closure Devices

Electrical Stimulation as a Treatment for Pain and Other Conditions: Surface and Percutaneous (DME.00011)

This coverage guideline addresses certain types of electrical stimulation devices.

It has been revised to include external lower extremity nerve stimulation devices.

External lower extremity nerve stimulation devices are considered investigational and not medically necessary for all indications.

The CPT^® and HCPCS codes associated with this revised coverage guideline are 64999, 0278T, 0720T, 0766T, 0767T, 0783T, A4540, A4543, A4544, A4596, E0721, E0732, E0743, E0761, E0762, E0769, E1399, S8130, S8131, and S8930.

Brain Computer Interface Rehabilitation Devices (DME.00052)

This new coverage guideline addresses brain computer interface (BCI) rehabilitation devices. These are non-invasive devices designed to enable individuals, particularly those with neurological conditions such as stroke, to control external devices using their brain signals.

Brain computer interface rehabilitation devices, including but not limited to electroencephalography (EEG)-driven upper extremity powered exercisers, are considered investigational and not medically necessary.

The HCPCS code associated with this new coverage guideline is E0738.

Systems Pathology and Multimodal Artificial Intelligence Testing for Cancerous and Precancerous Conditions (LAB.00026)

This coverage guideline addresses the use of the systems pathology method for individuals with prostate cancer or Barrett’s esophagus, a condition that predisposes to the development of adenocarcinoma of the esophagus. Systems pathology and multimodal artificial intelligence testing are computer-based diagnostic tools combining data using the cellular and biologic features of a pathological specimen, which may include computerized image analysis and quantitative immunofluorescence, in addition to clinical information, such as age and clinical or pathological stage, with the results of other lab tests to estimate the risk of malignant transformation, cancer progression, recurrence, metastatic, mortality or response to drug therapy.

The scope of this coverage guideline has been expanded to include Barrett’s esophagus.

Use of laboratory tests using systems pathology and multimodal artificial intelligence methodology is considered investigational and not medically necessary for the testing of cancerous and precancerous lesions, including but not limited to prostate cancer and Barrett’s esophagus.

The CPT codes associated with this revised coverage guideline are 88399, 0108U, and 0376U.

Per-and Polyfluoroalkyl Substances Testing (LAB.00051)

Per-and polyfluoroalkyl substances (PFAS) are a large group of synthetic chemicals that have been used by numerous industrial and commercial sectors for products that benefited from PFAS’ unique properties, including its chemical and thermal stability, water, heat, grease, and oil-resistant qualities. PFAS have been shown to bioaccumulate and biomagnify in wildlife as well as readily accumulate in human tissues such as the lungs, liver, brain, and circulatory system of humans. Because PFAS do not fully biodegrade in the environment, they have been referred to as forever chemicals. Research has revealed possible associations between human exposures to certain PFAS and some adverse health outcomes.

PFAS testing may include some of the most studied PFAS substances such as: perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorodecanoic acid (PFDA), perfluoroundecanoic acid (PFUnDA), perfluorohexane sulfonic acid (PFHxS), perfluorononanoic acid (PFNA), 2- (N-Methyl-perfluorooctane sulfonamido) acetic acid (MeFOSAA).

This new coverage guideline addresses testing for PFAS in humans.

Testing for PFAS substances is considered investigational and not medically necessary for all indications.

The CPT codes associated with this new coverage guideline are 0394U, 0457U, 82542, 83921, and 84999.

Non-invasive Heart Failure and Arrhythmia Management and Monitoring Systems (MED.00134)

This coverage guideline addresses the use of non-invasive heart failure and arrhythmia management and monitoring systems as an early indicator for heart failure decompensation and arrhythmia detection.

The use of non-invasive heart failure and arrhythmia management and monitoring systems are considered investigational and not medically necessary for all indications.

The CPT and HCPCS codes associated with this revised coverage guideline are 93701, 0607T, 0608T, and E1399.

Hepzato Kit ™ (melphalan hepatic delivery system) (MED.00150)

This new coverage guideline addresses Hepzato Kit ™, a liver-directed therapy designed to administer high-dose melphalan via a hepatic arterial delivery system.

Liver-directed administration of high-dose melphalan (Hepzato Kit ™) is considered medically necessary when all of the following criteria are met:

• 18 years of age or older; and
• Weight of at least 35 kilograms (77 pounds); and
• Metastatic uveal melanoma, when all the following criteria are met:
  • Unresectable hepatic liver metastases, confirmed on imaging (computed tomography [CT] or magnetic resonance imaging [MRI]; and
  • Liver metastases affect no more than 50% of the liver; and
  • If extra-hepatic disease is present, it is:
    • Limited to the bone, lymph nodes, subcutaneous tissues, or lung; and
    • Amenable to either, resection or radiation; and
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1; and
• None of the following concomitant illnesses or conditions at the time of treatment initiation:
  • Active liver infection (such as Hepatitis B and Hepatitis C infection); or
  • Any condition which elevates the risk of bleeding from anticoagulation (for example, stroke or other intracranial abnormalities); or
  • Child-Pugh Class B or C cirrhosis; or
  • Known varices or lesions at risk of bleeding (such as, medium to large esophageal and gastric varices, active peptic ulcers or active intracranial metastases or brain lesions with a propensity to bleed); or
  • Uncorrectable coagulopathy or inability to safely tolerate temporary removal from long-term anti-coagulation therapy; or
  • Portal hypertension.

Liver-directed administration of high-dose melphalan (Hepzato Kit ™) is considered investigational and not medically necessary when the criteria above are not met, and for all other indications.

The CPT and HCPCS codes associated with this new coverage guideline are 37799 and J9248.

Patent Foramen Ovale and Left Atrial Appendage Closure Devices (SURG.00032)

The coverage guideline addresses the transcatheter closure of patent foramen ovale and transcatheter or open left atrial appendage (LAA) closure. The procedures may be performed to prevent stroke using cardiac occlusion devices.

It has been revised to consider transcatheter closure of a PFO for the prevention of stroke and transcatheter closure of a left atrial appendage to be not medically necessary when the medical necessity criteria are not met.

Also, transcatheter closure of a PFO is considered investigational and not medically necessary for all other indications (for example, migraines, decompression sickness, and platypnea-orthodeoxia syndrome).

The CPT codes associated with this revised coverage guideline are 93580, 33340, 33267, 33268, and 33269.

These coverage guidelines are available for review on our website at https://anthem.com/provider.