Billing chart: Blues highlight medical, benefit policy changes

0017U, 81219, 81270, 81402, 81403

Basic benefit and medical policy

Genetic testing: JAK2, MPL and CALR testing for myeloproliferative neoplasms

The safety and effectiveness of JAK2 testing has been established. It may be considered a useful diagnostic option for patients presenting with clinical, laboratory or pathologic findings suggesting polycythemia vera, essential thrombocythemia or primary myelofibrosis.

The safety and effectiveness of MPL and CALR testing have been established. They may be considered useful diagnostic options for patients presenting with clinical, laboratory or pathologic findings suggesting essential thrombocythemia or primary myelofibrosis.

The peer-reviewed medical literature hasn’t yet demonstrated the clinical utility for JAK2, MPL and CALR testing in other circumstances. Therefore, these services are considered experimental in all other situations, including, but not limited to, the following:

• Diagnosis of nonclassic forms of myeloproliferative neoplasms, known as MPNs
• Molecular phenotyping of patients with MPNs
• Monitoring, management or selecting treatment in patients with MPNs

Procedure code 0017U has been added as a covered service for members meeting selection criteria, effective Nov. 1, 2018.

Payment policy

It isn’t payable in an office or ambulatory surgical facility. Modifiers 26 and TC don’t apply.

Inclusionary guidelines:

JAK2 testing as a diagnostic option for patients presenting with clinical, laboratory or pathologic findings suggesting polycythemia vera, essential thrombocythemia or primary myelofibrosis.

Based on World Health Organization criteria, in the case of suspected polycythemia vera, documentation of serum erythropoietin level below the reference range for normal is recommended prior to JAK2 testing.

MPL and CALR testing as diagnostic options for patients presenting with clinical, laboratory or pathologic findings suggesting essential thrombocythemia or primary myelofibrosis.

Exclusionary guidelines:

JAK2, MPL and CALR testing in other circumstances including, but not limited to, the following:

• Diagnosis of nonclassic forms of myeloproliferative neoplasms
• Molecular phenotyping of patients with MPNs
• Monitoring, management or selecting treatment in patients with MPNs

J9299

Basic benefit and medical policy

Opdivo (nivolumab)

Effective Aug. 10, 2017, the FDA-approved indications for Opdivo (nivolumab), identified by procedure code J9299, NDC 00003 3774-12 and NDC 0000 3772-11, are being maintained.

77046, 77047

Basic benefit and medical policy

MRI for detection and diagnosis of breast cancer

The safety and effectiveness of magnetic resonance imaging of the breast have been established. It may be considered a useful diagnostic option for patients meeting criteria. The inclusionary criteria have been updated, effective March 1, 2019.

Payment policy

Subject to the PPO Radiology Management Program

Inclusions:

Note: All the following policy statements refer to performing MRI of the breast with a breast coil and the use of contrast. MRI of the breast without the use of a breast coil, regardless of the clinical indication, is considered experimental.

1. MRI of the breast may be considered medically appropriate for screening for breast cancer in patients at a high risk of breast cancer.

High-risk considerations

There is no standardized method for determining a woman’s risk of breast cancer that incorporates all possible risk factors. There are validated risk prediction models, but they are based primarily on family history.

Some known individual risk factors confer a high risk by themselves. The following list includes factors known to indicate a high risk of breast cancer:

• Lobular carcinoma in situ, atypical lobular hyperplasia/atypical ductal hyperplasia
• A known BRCA1 or BRCA2 variant
• Another gene variant associated with high risk, e.g., TP53 (Li-Fraumeni syndrome), PTEN (Cowden syndrome, Bannayan-Riley-Ruvalcaba syndrome), CDH1, STK11, ATM, CHEK2, PALB2, NBN, NF1
• High risk (lifetime risk about 20 percent or greater) of developing breast cancer as identified by models that are largely defined by family history
• Received radiotherapy to the chest between ages 10 to 30

A number of factors may increase the risk of breast cancer but don’t by themselves indicate high risk. It’s possible that combinations of these factors may be indicative of high risk, but it isn’t possible to give quantitative estimates of risk. As a result, it may be necessary to individualize the estimate of risk, whereby one would need to take into account the numerous risk factors. A number of risk factors, not individually indicating high risk, are included in the National Cancer Institute Breast Cancer Risk Assessment Tool (also called the Gail model). Risk factors in the model can be accessed online at https://bcrisktool.cancer.gov/.

National Cancer Care Network guidelines state there is insufficient evidence for any recommendations for breast MRI for patients with the following variants: BARD1, BRIP1, FANCC, MRE11A, MUTYH, RAD50, RINT1, SLX4, SMARCA, or XRCC2. Moreover, there are conflicting data regarding risks associated with RAD51C, RAD51D, MLH1, MSH2, MSH6, PMS2 and EPCAM gene deletion.

2. MRI of the breast is medically appropriate for the following indications:
   • Detection of a suspected occult breast primary tumor in patients with axillary nodal adenocarcinoma (i.e., negative mammography and physical exam)
   • Presurgical planning in patients with locally advanced breast cancer (before and after completion of neoadjuvant chemotherapy) to permit tumor localization and characterization
   • Determining the presence of pectoralis major muscle/chest wall invasion in patients with posteriorly located tumor
   • Evaluation of the contralateral breast in those patients with a new diagnosis of breast cancer when clinical and mammographic findings are normal
   • Preoperative tumor mapping of the involved (ipsilateral) breast to evaluate the presence of multicentric disease in patients with clinically localized breast cancer who are candidates for breast-conservation therapy.
   • Evaluation of a documented abnormality of the breast before obtaining an MRI-guided biopsy when there is documentation that other methods, such as palpation or ultrasound, aren’t able to localize the lesion for biopsy.

Exclusions:

• Screening technique in average-risk patients
• Screening technique for the detection of breast cancer when the sensitivity of mammography is limited (i.e., dense breasts)
• Diagnosis of low-suspicion findings on conventional testing not indicated for immediate biopsy and referred for short-interval follow-up
• Diagnosis of a suspicious breast lesion to avoid biopsy

A4351
A4352
A4353

Basic benefit and medical policy

A4351 and A4352 aren’t separately reimbursable when billed with A4353

Procedures codes A4351 and A4352 aren’t separately reimbursable when billed with A4353.

When procedure codes A4351 and A4352 are billed together with A4353, procedure codes A4351 and A4352 will reject. When procedure codes A4351 and A4352 are billed without A4353, then current processing of these codes will execute.

J0717

Basic benefit and medical policy

Cimzia (certolizumab pegol)

Effective May 25, 2018, Cimzia (certolizumab pegol) is payable for the following newly approved FDA indication: Treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. This is in addition to the existing payable indications for:

• Reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
• Treatment of adults with moderately to severely active rheumatoid arthritis.
• Treatment of adult patients with active psoriatic arthritis.
• Treatment of adults with active ankylosing spondylitis.

Cimzia (certolizumab pegol) is a tumor necrosis factor blocker.

Cimzia (certolizumab pegol) is administered by subcutaneous injection. The initial dose of Cimzia (certolizumab pegol) is 400 mg given as two subcutaneous injections of 200 mg.

69710, 69711, 69714, 69715, 69717, 69718, L8625, L8690, L8691, L8693, L8694

Basic benefit and medical policy

Implantable bone-conduction and bone-anchored hearing devices

The safety and effectiveness of unilateral or bilateral fully or partially implanted bone-conduction (bone-anchored) hearing aids have been established. They may be considered a useful therapeutic option when indicated.

Inclusionary criteria have been updated, effective March 1, 2019.

Inclusions:

Conductive hearing loss
Unilateral or bilateral fully or partially implantable bone-conduction** (bone-anchored) hearing aids may be necessary as an alternative to an air-conduction hearing aid in patients age 5 and older with conductive or mixed hearing loss who also meet at least one of the following criteria:

• Congenital or surgically induced malformations (e.g., atresia) of the external ear canal or middle ear
• Chronic external otitis or otitis media
• Tumors of the external canal and/or tympanic cavity
• Chronic dermatitis of the external canal prohibiting the usage of an air-conduction hearing aid

And meet the following audiologic criteria:

• A pure-tone average bone-conduction threshold measured at 0.5, 1, 2 and 3 kHz or better than or equal to 45 dB (OBC and BP100, Baha 4 and Baha 5 devices), 55 dB (Intenso device) or 65 dB (Cordele II and Baha 5 SuperPower devices).

For bilateral implantation, patients should meet the above audiologic criteria in both ears and have symmetrically conductive or mixed hearing loss as defined by a difference between left and right side bone-conduction threshold of less than 10 dB on average measured at 0.5, 1, 2 and 3 kHz (4 kHz for OBC and Ponto Pro), or less than 15 dB at individual frequencies.

Sensorineural hearing loss**

A unilateral implantable bone-conduction (bone-anchored) hearing aid may be considered medically necessary as an alternative to an air-conduction contralateral routing of signal hearing aid in patients age 5 and older with single-sided sensorineural deafness and normal hearing in the other ear. The pure-tone average air-conduction threshold of the normal ear should be better than 20 dB measured at 0.5, 1, 2 and 3 kHz.

**The Audiant^® bone conductor is a bone-conduction hearing device. While this product is no longer actively marketed, patients with existing Audiant devices may require replacement, removal or repair.

In patients being considered for implantable bone-conduction (bone-anchored) hearing aids, skull bone quality and thickness should be assessed for adequacy to ensure implant stability. Additionally, patients (or caregivers) must be able to perform proper hygiene to prevent infection and ensure the stability of the implants and percutaneous abutments.

Exclusions:

Other uses of implantable bone-conduction (bone-anchored) hearing aids, including use in patients with bilateral sensorineural hearing loss, are considered experimental.

81201-81203, 81210, 81288, 81292- 81301, 81317-81319, 81401, 81403, 81406, 81435, 81436

Not covered:
81327, 81528

Basic benefit and medical policy

Genetic testing for Lynch and other inherited colon cancer syndromes

The safety and effectiveness of genetic testing for polyposis and non-polyposis cancer syndromes have been established. They may be considered useful diagnostic options for individuals who meet clinical criteria for increased risk of hereditary colorectal cancer.

Inclusionary criteria have been updated, effective March 1, 2019.

Inclusions:

These guidelines refer to the different types of genetic tests available for colorectal cancer.

1. Genetic testing of the adenosis polyposis coli, or APC, gene is established in any of the following:
   • At-risk relatives** (i.e., siblings, parents and offspring) of patients with FAP or AFAP or a known APC variant.
   • Patients with a differential diagnosis of attenuated FAP versus MUTYH-associated polyposis, or MAP, versus Lynch syndrome. Whether testing begins with APC variants or screening for mismatch repair MMR variants depends on clinical presentation.

**Due to the high lifetime risk of cancer of the majority of the genetic syndromes discussed in this policy, "at-risk relatives" primarily refers to first-degree relatives. However, some judgment must be allowed, for example, in the case of a small family pedigree, when extended family members may need to be included in the testing strategy.

It’s recommended that, when possible, initial genetic testing for familial adenomatous polyposis, known as FAP, or Lynch syndrome be performed in an affected family member so that testing in unaffected family members can focus on the variant found in the affected family member.

2. Genetic testing for MUTYH gene variants is established in all the following:
   • Patients with a differential diagnosis of attenuated familial adenomatous polyposis (FAP) vs. MUTYH-associated polyposis (MAP) vs. Lynch syndrome
   • Negative result for APC gene variants
   • Negative family history of no parents or children with FAP is consistent with autosomal recessive MAP

In many cases, genetic testing for MUTYH gene variants should first target the specific variants Y165C and G382D, which account for more than 80 percent of variants in white populations and subsequently proceed to sequencing only as necessary. In other ethnic populations, however, proceeding directly to sequencing is appropriate.

3. Genetic testing for MMR gene variants (MLH1, MSH2, MSH56, PMS2) to determine the carrier status of Lynch syndrome is established in any of the following:
   • Patients with colorectal cancer to test for the diagnosis of Lynch syndrome
   • Patients with endometrial cancer and a first-degree relative diagnosed with a Lynch-associated cancer, for the diagnosis of Lynch syndrome
   • At-risk relatives of patients with Lynch syndrome with a known MMR variant
   • Patients with a differential diagnosis of attenuated FAP versus MAP versus Lynch syndrome. Whether testing begins with APC variants or screening for MMR genes depends on clinical presentation.
   • Patients without colorectal cancer but with a family history meeting the Amsterdam or revised Bethesda criteria when:
     • No affected family members have been tested for MMR variants.

For patients with colorectal cancer being evaluated for Lynch syndrome, either the microsatellite instability, known as MSI, test or the immunohistochemical, known as IHC, test with or without BRAF gene variant testing, should be used as an initial evaluation of tumor tissue before mismatch repair MMR gene analysis. Both tests are not necessary. Proceeding to MMR gene sequencing would depend on results of MSI or IHC testing. In particular, IHC testing may help direct which MMR gene likely contains a variant, if any, and may also provide additional information if MMR genetic testing is inconclusive.

When indicated, genetic sequencing for MMR gene variants should begin with MLH1 and MSH2 genes, unless otherwise directed by the results of IHC testing. Standard sequencing methods won’t detect large deletions or duplications; when MMR gene variants are expected based on IHC or MSI studies but none are found by standard sequencing, additional testing for large deletions or duplications is appropriate.

4. Genetic testing for EPCAM gene variants is established when any of the following major criteria (solid bullets) is met:
   • Patients with colorectal cancer, for the diagnosis of Lynch syndrome when (one of the following):
     • Tumor tissue shows lack of MSH2 protein expression by immunohistochemistry and patient is negative for a MSH2 germline variant.
     • Tumor tissue shows a high level of microsatellite instability and patient is negative for a germline variant in MSH2, MLH1, PMS2 and MSH6.
   • At-risk relatives of patients with Lynch syndrome with a known EPCAM variant
   • Patients without colorectal cancer but with a family history meeting the Amsterdam or revised Bethesda criteria when (each of the following):
     • No affected family members have been tested for MMR variants.
     • Sequencing for MMR variants is negative.

The Amsterdam II clinical criteria (all criteria must be fulfilled) are the most stringent criteria for defining families at a high risk for Lynch syndrome (Vasen et al., 1999):

• Three or more relatives with an associated cancer (colorectal cancer or cancer of the endometrium, small intestine, ureter or renal pelvis)
• One should be a first-degree relative of the other two.
• Two or more successive generations affected
• One or more relatives diagnosed before age 50
• Familial adenomatous polyposis should be excluded in cases of colorectal carcinoma.
• Tumors should be verified by pathologic examination.
• Modifications, one of the following:
  • Very small families, which can’t be further expanded, can be considered to have hereditary nonpolyposis colorectal cancer with only two colorectal cancers in first-degree relatives if at least two generations have the cancer and at least one case of colorectal cancer was diagnosed by the age of 55.
  • In families with two first-degree relatives affected by colorectal cancer, the presence of a third relative with an unusual early-onset neoplasm or endometrial cancer is sufficient.

The revised Bethesda guidelines (fulfillment of any criterion meets guidelines) are less strict than the Amsterdam criteria and are intended to increase the sensitivity of identifying at-risk families (Umar et al., 2004). The Bethesda guidelines are also considered more useful in identifying which patients with colorectal cancer should have their tumors tested for microsatellite instability and/or immunohistochemistry:

• Colorectal carcinoma, or CRC, diagnosed in a patient who is younger than age 50.
• Presence of synchronous or metachronous CRC or other HNPCC-associated tumors,** regardless of age.
• CRC with high microsatellite instability histology diagnosed in a patient younger than age 60.
• CRC diagnosed in one or more first-degree relatives with a Lynch syndrome-associated tumor, with one of the cancers being diagnosed at younger than age 50.
• CRC diagnosed in two or more first- or second-degree relatives with HNPCC-related tumors,** regardless of age.

**HNPCC-related tumors include colorectal, endometrial, stomach, ovarian, pancreas, ureter and renal pelvis, biliary tract, brain (usually glioblastoma as seen in Turcot syndrome), sebaceous bland adenomas and keratoacanthomas in Muir-Torre syndrome, and carcinoma of the small bowel.

5. Genetic testing for BRAF V600E or MLH1 promoter methylation is established to exclude a diagnosis of Lynch syndrome when:
   • MLH1 protein is not expressed in a colorectal cancer tumor on immunohistochemical analysis.
6. Genetic testing for SMAD4 and BMPR1A gene variants is established when any of the following major criteria (solid bullets) is met:
   • Individual has a clinical diagnosis of juvenile polyposis syndrome based on the presence of any one of the following:
     • At least three to five juvenile polyps in the colon.
     • Multiple juvenile polyps in other parts of the gastrointestinal tract.
     • Any number of juvenile polyps in a person with a known family history of juvenile polyps.
   • Individual is an at-risk relative of a patient suspected of or diagnosed with juvenile polyposis syndrome.
7. Genetic testing for STK11 gene variants is established when any of the following major criteria (solid bullets) is met:
   • Individual has a clinical diagnosis of Peutz-Jeghers syndrome based on the presence of any two of the following secondary criteria:
     • Presence of two or more histologically confirmed Peutz-Jeghers polyps of the small intestine.
     • Characteristic mucocutaneous pigmentation of the mouth, lips, nose, eyes, genitalia or fingers.
     • Family history of Peutz-Jeghers syndrome.
   • Individual is an at-risk relative of a patient suspected of or diagnosed with Peutz-Jeghers syndrome.

Pre- and post-test genetic counseling is established as an adjunct to genetic testing.

Note: Genetic counseling is primarily aimed at patients who are at risk for inherited disorders, and experts recommend formal genetic counseling in most cases when genetic testing for an inherited condition is considered. The interpretation of the results of genetic tests and the understanding of risk factors can be very difficult and complex. Therefore, genetic counseling will assist individuals in understanding the possible benefits and harms of genetic testing, including the possible effect of the information on the individual’s family. Genetic counseling may alter the utilization of genetic testing substantially and may reduce inappropriate testing. Genetic counseling should be performed by an individual with experience and expertise in genetic medicine and genetic testing methods.

Exclusions:

Genetic testing for APC gene variants is considered investigational for colorectal cancer patients with classical FAP for confirmation of the FAP diagnosis.

Genetic testing for all other gene variants for Lynch syndrome or colorectal cancer is considered experimental.

Established: 95249, 95250, 95251, A9276, A9277, A9278, A9279, K0553, K0554

Investigational: 99091, S1030, S1031

Basic benefit and medical policy

Intermittent (72 hours or more) or continuous invasive glucose monitoring

The safety and effectiveness of FDA-approved continuous glucose monitoring systems, on an intermittent (72 hours or more) or continuous basis, have been established. Both may be considered useful therapeutic devices for patients meeting the relevant patient selection criteria. The inclusionary criteria have been updated.

This policy is effective March 1, 2019.

Inclusions:

Seventy-two hour monitoring of glucose levels in interstitial fluid to optimize patient management may be considered established in the following situations when any of the following criteria are met:

• Patients with Type 1 diabetes who despite current use of best practices have poorly controlled diabetes, including hemoglobin A1c not in acceptable target range for the patient’s clinical situation, unexplained hypoglycemic episodes, evidence suggesting postprandial hyperglycemia or recurrent diabetic ketoacidosis
• Patients with Type 1 diabetes before insulin pump initiation to determine basal insulin levels
• Women with Type 1 diabetes who are pregnant or about to become pregnant and have poorly controlled diabetes

Continual (i.e., long-term) monitoring of glucose levels in interstitial fluid, including real-time monitoring, as a technique in diabetic monitoring may be considered established in any of the following situations:

• Patients with Type 1 diabetes who have demonstrated an understanding of the technology, are motivated to use the device correctly and consistently, are expected to adhere to a comprehensive diabetes treatment plan supervised by a qualified provider and are capable of using the device to recognize alerts and alarms
• Patients with Type 1 diabetes who have recurrent, unexplained, severe (generally blood glucose levels <50 mg/dL) hypoglycemia or impaired awareness of hypoglycemia that puts the patient or others at risk
• Patients with poorly controlled Type 1 diabetes who are pregnant. Poorly controlled Type 1 diabetes includes unexplained hypoglycemic episodes, hypoglycemic unawareness, suspected postprandial hyperglycemia and recurrent diabetic detoacidosis.

Intermittent monitoring of glucose levels in interstitial fluid may also be considered established in patients with Type 1 diabetes before insulin pump initiation to determine basal insulin levels.

Exclusions:

Other uses of continuous monitoring of glucose levels in interstitial fluid (including real-time monitoring) as a technique of diabetic monitoring are considered experimental, including:

• Patients not meeting the inclusionary criteria above.
• For convenience purposes, such as (but not limited to) lifestyle or employment circumstances.

Replacement:

Replacement of a CGMS may be considered when:

• The transmitter is out of warranty.
• The transmitter is malfunctioning.
• There is documented evidence the member is compliant with their current CGMS device. Compliance is defined as at least 70 percent use rate of the device (e.g., five out of seven days) based on the log data.

Continuation of sensor use after one year may be considered when:

• The CGMS has been previously approved by the health plan or the CGMS is in use prior to the user enrolling in the health plan.
• There is documented evidence the member is compliant with his or her current CGMS device. Compliance is defined as at least 70 percent use rate of the device (e.g., five out of seven days) based on the log data.

All covered supplies must be compatible with the CGMS.

64450**
64640**
64999**

**When specified as ablation of genicular nerves

Basic benefit and medical policy

Genicular nerve blocks

Genicular nerve blocks for the treatment of chronic knee pain (e.g., degenerative joint disease, osteoarthritis, treatment before knee replacement or after knee replacement or instead of knee replacement) are experimental. It hasn’t been scientifically demonstrated to improve patient clinical outcomes, effective March 1, 2019.