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July 2020

Billing chart: Blues highlight medical, benefit policy changes

You’ll find the latest information about procedure codes and Blue Cross Blue Shield of Michigan billing guidelines in the following chart.

This billing chart is organized numerically by procedure code. Newly approved procedures will appear under the New Payable Procedures heading. Procedures for which we have changed a billing guideline or added a new payable group will appear under Updates to Payable Procedures. Procedures for which we are clarifying our guidelines will appear under Policy Clarifications. New procedures that are not covered will appear under Experimental Procedures.

You will also see that descriptions for the codes are no longer included. This is a result of recent negotiations with the AMA on use of the codes.

We will publish information about new BCBS groups or changes to group benefits under the Group Benefit Changes heading.

For more detailed descriptions of the BCBSM policies for these procedures, please check under the Medical/Payment Policy tab in Explainer on web-DENIS. To access this online information:

  • Log in to web-DENIS.
  • Click on BCBSM Provider Publications & Resources.
  • Click on Benefit Policy for a Code.
  • Click on Topic.
  • Under Topic Criteria, click on the drop-down arrow next to Choose Identifier Type and then click on HCPCS Code.
  • Enter the procedure code.
  • Click on Finish.
  • Click on Search.
Code* BCBSM changes to:
Basic Benefit and Medical Policy, Group
Variations Payment Policy, Guidelines
UPDATES TO PAYABLE PROCEDURES

J3490
J3590

Basic benefit and medical policy

Avsola (infliximab-axxq)

Avsola (infliximab-axxq) is payable when billed for FDA-approved indications, effective Dec. 6, 2019. Avsola (infliximab-axxq) should be reported with procedure code J3490 or J3590 and the appropriate national drug code until a permanent code is established.

URMBT groups are excluded from coverage of this drug. 

Avsola (infliximab-axxq) is a biosimilar to Remicade (infliximab). It’s a tumor necrosis factor, or TNF, blocker indicated for the following:

  • Crohn’s disease
  • Pediatric Crohn’s disease
  • Ulcerative colitis
  • Pediatric ulcerative colitis
  • Rheumatoid arthritis in combination with methotrexate
  • Ankylosing spondylitis
  • Psoriatic arthritis
  • Plaque psoriasis

Dosage and administration:

Avsola (infliximab-axxq) is administered by intravenous infusion over a period of not less than two hours.

Crohn’s disease: 5 mg/kg at zero, two and six weeks, then every eight weeks. Some adult patients who initially respond to treatment may benefit from increasing the dose to 10 mg/kg if they later lose their response.

Pediatric Crohn’s disease: 5 mg/kg at zero, two and six weeks, then every eight weeks.

Ulcerative colitis: 5 mg/kg at zero, two and six weeks, then every eight weeks.

Pediatric ulcerative colitis: 5 mg/kg at zero, two and six weeks, then every eight weeks.

Rheumatoid arthritis: In conjunction with methotrexate, 3 mg/kg at zero, two and six weeks, then every eight weeks. Some patients may benefit from increasing the dose up to 10 mg/kg or treating as often as every four weeks.

Ankylosing spondylitis: 5 mg/kg at zero, two and six weeks, then every six weeks.

Dosage forms and strengths:

For injection: 100 mg of lyophilized infliximab-axxq in a 20 mL single-dose vial for intravenous infusion.

J3490
J3590

Basic benefit and medical policy

Barhemsys (amisulpride)

Barhemsys (amisulpride) is payable when billed for the FDA-approved indications, effective Feb. 26, 2020. Barhemsys (amisulpride) should be reported with procedure code J3490 or J3590 and the appropriate national drug code until a permanent code is established.

URMBT groups are excluded from coverage of this drug. 

Barhemsys (amisulpride) is a dopamine-2, or D2, antagonist indicated in adults for:

  • Prevention of postoperative nausea and vomiting, or PONV, either alone or in combination with an antiemetic of a different class.
  • Treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or haven’t received prophylaxis.

Dosage and administration:

Prevention of PONV, either alone or in combination with another antiemetic: 5 mg as a single intravenous dose infused over one to two minutes at the time of induction of anesthesia.

Treatment of PONV: 10 mg as a single intravenous dose infused over one to two minutes in the event of nausea and/or vomiting after a surgical procedure.

Dosage forms and strengths

Injection: 5 mg/2 mL (2.5 mg/mL) in a single-dose vial.

J9271

Basic benefit and medical policy

Keytruda (pembrolizumab)

Payable diagnoses for Keytruda (pembrolizumab) have been updated. Diagnosis 15.8 and C69.92 have been added as payable for Keytruda (pembrolizumab).
POLICY CLARIFICATIONS

Established
0191T, 0376T, 66179, 66180, 66183, 66184, 66185, 66982, 66983, 66984, 0449T, 0450T, 0474T

Experimental
66999, 0253T

Basic benefit and medical policy

Aqueous Shunts and Stents for Glaucoma policy

The criteria have been updated for the Aqueous Shunts and Stents for Glaucoma policy. Procedure code 0376T is now payable when billed in conjunction with procedure code 0191T.

If procedure code 0376T is billed alone or with any other procedure code, it should remain experimental.

Inclusions:

Insertion of FDA-approved aqueous shunts is considered established as a method to reduce intraocular pressure in patients with mild to moderate open-angle glaucoma when conventional pharmacologic treatments have failed to control intraocular pressure adequately.  

Currently available FDA-approved shunts include:

  • Ahmed™ glaucoma implant
  • Baerveldt® seton
  • Ex-PRESS® mini glaucoma shunt
  • Glaucoma pressure regulator
  • Krupin-Denver valve implant
  • Molteno® implant
  • Schocket shunt
  • Xen® Gel Stent
  • CyPass® Micro-Stent (recalled)
  • iStent®
  • iStent inject®
  • Hydrus™

Note: The CyPass Micro-Stent (recalled), iStent and Hydrus are indicated for use in conjunction with cataract surgery for the reduction of IOP in adult patients with mild to moderate primary open-angle glaucoma.

The iStent Inject comes pre-loaded with two stents.

Exclusions:

  • The use of an aqueous shunt for all other conditions, including patients with glaucoma when intraocular pressure is controlled by medications
  • Insertion of aqueous shunts that aren’t FDA approved
  • For the iStent Micro Bypass Stent, patients with the following conditions aren’t appropriate candidates and the insertion of this stent would be considered experimental:
    • In children
    • In eyes with significant prior trauma
    • In eyes with abnormal anterior segment
    • In eyes with chronic inflammation
    • In glaucoma associated with vascular disorders
    • In pseudophakic patients with glaucoma
    • In uveitic glaucoma
    • In eyes with prior incisional glaucoma surgery or cilioablative procedures
    • In eyes with prior laser trabeculectomy with selective LT within 90 days prior to screening or prior to argon laser trabeculectomy at any time
    • In patients with medicated intraocular pressure greater than 24 mm Hg
    • In patients with unmedicated IOP less than 21 mm Hg nor greater than 36 mm Hg after "washout" of medications
    • After complications during cataract surgery, including but not limited to, severe corneal burn, vitreous removal/vitrectomy required, corneal injuries, or complications requiring the placement of an anterior chamber IOL (intraocular lens)
    • When implantation has been without concomitant cataract surgery with IOL implantation for visually significant cataract
    • In patients with pseudoexfoliative glaucoma or pigmentary glaucoma, or in patients with other secondary open-angle glaucoma
  • For the iStent Inject, patients with the following conditions are not appropriate candidates and the insertion of this stent would be considered experimental:
    • Quick or sudden increase in eye pressure
    • Inflammation of the eye tissue (uvea)
    • Neovascular glaucoma
    • Noticeable birth irregularities on the front of the eye
    • Orbital tumor
    • Thyroid eye disease
    • Sturge-Weber syndrome
    • Any other type of condition that may cause elevated pressure in the veins of the eye
  • For the Hydrus Microstent, patients with the following conditions aren’t appropriate candidates and the insertion of this stent would be considered experimental:
    • When the colored part of the eye (iris) is pushed up against the drainage pathway or when other material blocks the drainage pathway
    • Traumatic glaucoma, malignant glaucoma or inflammation of the eye tissue
    • Glaucoma associated with the growth of abnormal blood vessels in the eye
    • Noticeable birth irregularities of the anterior chamber angle

The policy effective date is Nov. 1, 2019.

20930, 20931, 20939, 20999, 0565T, 0566T

Procedures added
20930, 20931, 0565T, 0566T

Basic benefit and medical policy

Orthopedic Applications of Stem-Cell Therapy (including Allografts and Bone Substitutes used with Autologous Bone Marrow) policy

New procedure codes have been added to the Orthopedic Applications of Stem-Cell Therapy (including Allografts and Bone Substitutes used with Autologous Bone Marrow) policy.

Medical policy statement

Mesenchymal stem cell therapy is considered experimental for all orthopedic applications, including use in repair or regeneration of musculoskeletal tissue.

Allograft bone products containing viable stem cells, including but not limited to demineralized bone matrix with stem cells, are considered experimental for all orthopedic applications.

Allograft or synthetic bone graft substitutes that must be combined with autologous blood or bone marrow are considered experimental for all orthopedic applications.

The safety and efficacy of these treatments haven’t been established.

The policy effective date is July 1, 2020.

66820, 66821, 66830, 66840, 66850, 66852, 66920, 66930, 66940, 66982, 66983, 66984, 66987, 66988

Basic benefit and medical policy

Cataract removal surgery

The safety and efficacy of cataract removal surgery, with or without intraocular lens, or IOL, implantation, have been established. It’s considered an effective treatment when clinical criteria are met.

Policy criteria have been updated regarding intraocular lenses, effective July 1, 2020.

Inclusions:

Cataract removal surgery (with or without IOL implantation) may be an appropriate treatment for adult members when all the following criteria are met:

  • The patient has a decreased ability to carry out activities of daily living such as reading, watching television, driving or meeting occupational or vocational expectations.
  • The patient has a best corrected visual acuity of 20/40 or worse at distance or near; or additional testing reveals one of the following:
    • Consensual light testing decreases visual acuity by two lines
    • Glare testing decreases visual acuity by two lines
  • Other eye diseases, such as macular degeneration or diabetic retinopathy, have been ruled out as the only cause of decreased visual function.
  • Significant improvement in visual function can be expected as a result of cataract extraction.
  • The patient has undergone a preoperative ophthalmologic evaluation that includes a comprehensive ophthalmologic exam and ophthalmic biometry
  • If cataracts exist in both eyes and require surgery, the surgery will be performed on each eye at separate times, usually four to eight weeks apart.
  • The patient has been educated about the risks and benefits of cataract surgery and the alternatives to surgery (e.g., avoidance of glare, optimal eyeglass prescription, etc.).

Additional indications for cataract removal may include:

  • Lens-induced disease or angle closure (phacomorphic glaucoma, phagolytic glaucoma, phacolysis, phacoanaphylaxis and other lens-induced disease may require cataract surgery and the need for extraction may be urgent)
  • The need to visualize the fundus (e.g., the patient has diabetes with significant risk of reduced visual acuity from diabetic retinopathy requiring management through visualization for diagnosis or clear media laser therapy)
  • Capsular rupture with lens swelling
  • Other trauma-induced ocular pathology necessitating surgery
  • Reduced contrast sensitivity that correlates with the patient’s subjective and objective assessments
  • Double vision in the affected eye
  • Clinically significant anisometropia in the presence of a cataract
  • The lens opacity interferes with optimal diagnosis or management of posterior segment conditions
  • Refractory correcting IOLs**

**Refractory correcting IOLs are considered deluxe items and are therefore considered not medically necessary. Patients must be advised in advance that deluxe or enhancement items are the financial responsibility of the member. It’s the providers’ responsibility to obtain a signed copy of the Advanced Notice of Member Responsibility form from the member and bill with the appropriate modifiers. Failure to appropriately execute an Advanced Notice of Member Responsibility form and bill with the correct modifiers will cause the claim to reject. The provider will be liable for the item and/or service and the member may not be billed.

For pediatric members, cataract removal surgery without IOL implantation may be considered an appropriate treatment when any of the following criteria are met:
 

  • Dense central opacity larger than 3 mm in diameter
  • In partial cataracts, surgery is indicated when the visual acuity is less than 6/18 or, in preverbal children, when fixation is poor
  • Capsular rupture with lens swelling
  • Other trauma-induced ocular pathology necessitating cataract surgery

Note: IOL implants are not FDA approved for children under the age 18.

Exclusions:

For adult members:

  • Glasses or visual aids provide functional vision satisfactory to the patient's needs and desires
  • Surgery isn’t expected to improve visual function, and no other indication for lens removal exists
  • The patient can’t safely undergo surgery because of coexisting medical or ocular conditions
  • Functional improvement is unlikely due to concomitant disease
  • Active proliferative diabetic retinopathy (unless cataract removal is necessary to allow visualization of the retina)
  • The presence of rubeosis iridis and/or neovascular glaucoma

For pediatric members:

  • IOLs haven’t received regulatory approval for use in children under the age of 18
  • The presence of a severe life-limiting disease
  • Cases of severe microphthalmia (corneal diameter less than 5 mm)
  • Cases in which the retina is irreparably detached or the posterior segment is disorganized
  • The presence of untreated retinoblastoma

Established codes:
78608, 78609, 78811, 78812, 78813, 78814, 78815, 78816, 78899, G0235, 78812, 78813, 78814, G0253
           
Other codes (experimental, not medically necessary, etc.):
G0219, G0252

Basic benefit and medical policy

Positron Emission Tomography for Oncologic Conditions policy

The criteria have been updated for the Positron Emission Tomography for Oncologic Conditions medical policy.

The policy is effective July 1, 2020.

General statements:

All inclusionary/exclusionary statements apply to both PET scans and PET/computed tomography scans, i.e., PET scans with or without PET/CT fusion.

A PET or PET/CT may be appropriate for a patient with known diagnosis of a malignancy to determine the optimal anatomic site for a biopsy or other invasive diagnostic procedure if standard imaging is equivocal. It also may replace conventional imaging when conventional imaging would be inadequate for accurate staging, and when clinical management will depend upon the stage of disease. In general, for most solid tumors, a tissue diagnosis is made prior to the performance of PET scanning. PET scans following a tissue diagnosis are performed for staging, not diagnosis. If the results of the PET scan won’t influence treatment decisions, these situations would be considered not medically necessary.

PET scans may be considered appropriate for the following oncologic conditions:

Anal cancer
Inclusions:

  • For the diagnosis, staging, restaging and monitoring of anal cancer

Exclusions:

  • Conditions not listed above

Bladder cancer
Inclusions:

  • For the staging or restaging of muscle invasive bladder cancer

Exclusions:

  • Conditions not listed above

Bone cancer
Inclusions:

  • For the staging of Ewing sarcoma and osteosarcoma

Exclusions:

  • For the staging of chondrosarcoma

Brain cancer
Inclusions:

  • For diagnosis and staging, where lesions metastatic from the brain are identified but no primary is found
  • For restaging, to distinguish recurrent tumor from radiation necrosis

Exclusions:

  • Conditions not listed above

Breast cancer
Inclusions:

  • Staging and restaging of breast cancer
  • Detecting locoregional or distant recurrence or metastasis (except axillary lymph nodes) when suspicion of disease is high and other imaging is inconclusive
  • Staging axillary lymph nodes

Exclusions:

  • For the differential diagnosis in patients with suspicious breast lesions or an indeterminate/low suspicion finding on mammography
  • For predicting pathologic response to neoadjuvant therapy for locally advanced disease

Cancer of unknown primary
Inclusions:

  • Patients with an unknown primary who meet all of the following criteria:
    • In patients with a single site of disease outside the cervical lymph nodes.
    • Patient is considering local or regional treatment for a single site of metastatic disease.
    • Patient has received a negative workup for a occult primary tumor.
    • The PET scan will be used to rule out or detect additional sites of disease that would eliminate the rationale for local or regional treatment.

Exclusions:

  • For patients with an unknown primary, including, but not limited to, the following:
    • As part of the initial workup of an unknown primary
    • As part of the workup of patients with multiple sites of disease

Cervical cancer
Inclusions:

  • For the initial staging of patients with locally advanced cervical cancer
  • For the evaluation of known or suspected recurrence

Exclusions:

  • For the initial diagnosis of cervical cancer in all other situations

Colorectal cancer
Inclusions:

  • Staging and restaging (initial and subsequent treatment strategy) to detect and assess resectability of hepatic or extrahepatic metastases of colorectal cancer
  • To evaluate a rising and persistently elevated carcinoembryonic antigen, or CEA, level when standard imaging, including CT scan, is negative

Exclusions:

  • When used as a technique to assess the presence of scarring versus local bowel recurrence in patients with previously resected colorectal cancer
  • When used as a technique contributing to radiotherapy treatment planning

Endometrial cancer
Inclusions:

  • Detection of lymph node metastases
  • Assessment of endometrial cancer recurrence

Exclusions:

  • Conditions not listed above

Esophageal cancer
Inclusions:

  • Staging and restaging of esophageal cancer 
  • Determining response to preoperative induction therapy

Exclusions:

  • Detection of primary esophageal cancer

Gastric (stomach) cancer
Inclusions:

  • Diagnosis, staging and restaging of gastric carcinoma if other imaging is inconclusive
  • Determining response to preoperative induction therapy

Exclusions:

  • Conditions not listed above

Head and neck cancer
Inclusions:

  • For the evaluation of the head and neck in the diagnosis of suspected head and neck cancer
  • For the initial staging of the disease
  • For restaging of residual or recurrent disease during follow up after treatment for their head and neck cancer

Exclusions:

  • Conditions not listed above

Hepatobiliary cancer
Inclusions:

  • When standard imaging studies are equivocal or nondiagnostic regarding extent of disease
  • When standard imaging prior to planned curative surgery has been performed and hasn’t demonstrated metastatic disease

Exclusions:

  • Conditions not listed above

Lung cancer
Inclusions:

  • Patients with a solitary pulmonary nodule as a single-scan technique (not dual-time) to distinguish between benign and malignant disease when prior CT scan and chest X-ray findings are inconclusive or discordant
  • To determine resect ability for patients with a presumed solitary metastatic lesion from lung cancer
  • As a staging or restaging technique in those with known non-small-cell lung cancer
  • PET scanning may be considered established in staging of small-cell lung cancer if limited stage is suspected based on standard imaging

Exclusions:

  • PET scanning in staging of small-cell lung cancer if extensive stage is established and in all other aspects of managing small-cell lung cancer
  • Conditions not listed above

Lymphoma, including Hodgkin’s disease
Inclusions:

  • PET scanning as a technique for staging lymphoma either during initial staging or for restaging at follow-up

Exclusions:

  • Conditions not listed above

Melanoma
Inclusions:

  • Assessing extranodal spread of malignant melanoma at initial staging or at restaging during follow-up treatment for advanced disease

Exclusions:

  • In managing Stage 0, I or II melanoma.
  • When used as a technique to detect regional lymph node metastases in patients with clinically localized melanoma who are candidates to undergo sentinel node biopsy

Multiple myeloma
Inclusions:

  • For the initial and subsequent treatment strategy of multiple myeloma

Exclusions:

  • Not applicable

Merkel cell carcinoma
Inclusions:

  • As clinically indicated

Neuroendocrine tumors
Inclusions:

  • For the diagnosis, staging, restaging and monitoring of neuroendocrine tumors

Exclusions:

  • Conditions not listed above

Ovarian cancer
Inclusions:

  • Initial staging of ovarian cancer.
  • For the evaluation of patients with signs or symptoms of suspected ovarian cancer recurrence (restaging) when standard imaging, including CT scan, is inconclusive

Exclusions:

  • For the initial evaluation (not staging) of known or suspected ovarian cancer in all other situations

Pancreatic cancer
Inclusions:

  • For the initial diagnosis and staging of pancreatic cancer when other imaging and biopsy are inconclusive

Exclusions:

  • Evaluating other aspects of pancreatic cancer

Penile cancer
Inclusions:

  • Staging inguinal lymph nodes in patients with squamous cell carcinoma of the penis

Exclusions:

  • All other indications

Pleural, thymus, heart and mediastinum cancer
Inclusions:

  • For surgical resection being considered and metastatic disease hasn’t been detected by CT or MRI
  • For restaging after induction chemotherapy, if the patient is a surgical candidate

Exclusions:

  • All other indications

Prostate cancer
Inclusions:

  • PET scanning with 11C-choline for evaluating response to primary treatment in prostate cancer

Exclusions:

  • PET scanning with 68Gallium in all aspects of managing prostate cancer
  • PET scanning for all other indications

Renal cell carcinoma
Inclusions:

  • For initial treatment strategy, subsequent treatment strategy and surveillance of biopsy proven kidney cancer

Exclusions:

  • Not applicable

Soft tissue sarcoma
Inclusions:

  • For initial staging prior to resection of an apparently solitary metastasis
  • When the grade of an unresectable tumor remains in doubt after biopsy
  • Differentiation of suspected tumor from radiation or surgical fibrosis
  • Determination of response to therapy, gastrointestinal stromal tumor for initial staging and re-staging when there is documented recurrence

Exclusions:

  • When used in evaluation of soft tissue sarcoma, including but not limited to the following applications:
    • Distinguishing between low-grade and high-grade soft tissue sarcoma
    • Detecting locoregional recurrence
    • Detecting distant metastasis

Testicular cancer
Inclusions:

  • PET canning in the evaluation of residual mass following chemotherapy of Stage IIB and III seminomas

Exclusions:
•     All other indications

Thyroid cancer
Inclusions:

  • For the initial treatment strategy of thyroid cancer types known not to concentrate radioactive iodine, or RAI
  • For subsequent treatment strategy for differentiated thyroid cancer of follicular cell origin, which is known to concentrate radioactive iodine, in all the following situations:
    • When done following prior treatment with thyroidectomy and radioiodine ablation
    • With a current serum thyroglobulin > 10 ng/ml (except in the setting of documented anti-thyroglobulin antibodies)
    • With a negative whole-body RAI scan in the past

Exclusions:

  • For the evaluation of known or suspected differentiated or poorly differentiated thyroid cancer in all other situations

Vaginal/vulvar cancers
Inclusions:

  • Radiation planning
  • Standard imaging studies are equivocal or nondiagnostic for recurrent or progressive disease
  • Restaging of local recurrence when pelvic exenteration surgery is planned

Exclusions:

  • All other indications

Cancer surveillance
Inclusions:

  • Not applicable

Exclusions:

When used as a surveillance tool for patients with cancer or with a history of cancer. A scan is considered surveillance if performed more than six months after completion of cancer therapy (12 months for lymphoma) in patients without objective signs or symptoms suggestive of cancer recurrence.

Established codes:
Genetic testing in patients at risk for FAP: 81201, 81202, 81203

Genetic testing in patients at risk for Lynch syndrome (HNPCC): 81210, 81288, 81292, 81293, 81294, 81295, 81296, 81297, 81298, 81299, 81300, 81301, 81317, 81318 81319, 81401, 81403, 81406, 81435, 81436

Note: 81401 and 81406 include MUTYH (e.g., MYH-associated polyposis)

Other codes (experimental, not medically necessary, etc.): 81327, 81528

Basic benefit and medical policy

Genetic Testing for Lynch Syndrome and Other Inherited Colon Cancer Syndromes policy

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. This policy is effective July 1, 2020.

Inclusions:

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

  1. Genetic testing of the adenomatous polyposis coli gene, or APC, is established in any of the following:
    • At-riska (first- and second-degree) relatives of patients with familial adenomatous polyposis, or FAP, or attenuated familial adenomatous polyposis, 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.

aDue 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 (i.e., siblings, parents and offspring) and second-degree (i.e., grandparents, aunts, uncles, nieces, nephews, grandchildren and half-siblings) 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.

Note: It’s recommended that, when possible, initial genetic testing for familial adenomatous polyposis 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.

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

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

  1. Genetic testing for MMR gene variants (MLH1, MSH2, MSH6, 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 one first-degree relative or ≥ two second-degree relatives diagnosed with a Lynch-associated cancer, for the diagnosis of Lynch syndrome
    • At-riska (first- and second-degree) 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, or documentation of 5% or higher predicted risk of the syndrome on a validated risk prediction model (e.g., MMRpro, PREMM5 or MMRpredict) when no affected family members have been tested for MMR variants.

aDue 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 (i.e., siblings, parents and offspring) and second-degree (i.e., grandparents, aunts, uncles, nieces, nephews, grandchildren and half-siblings) 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.

Note: For patients with colorectal cancer being evaluated for Lynch syndrome, either the microsatellite instability, or MSI, test or the immunohistochemical, or 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 aren’t 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.

Note: 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.

  1. 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 in 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-riska (first- and second-degree) 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, or documentation of 5% or higher predicted risk of the syndrome on a validated risk prediction model (e.g., MMRpro, PREMM5 or MMRpredict) when both of the following are met:
      • No affected family members have been tested for MMR variants.
      • Sequencing for MMR variants is negative.

aDue 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 (i.e., siblings, parents and offspring) and second-degree (i.e., grandparents, aunts, uncles, nieces, nephews, grandchildren and half-siblings) 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.

The Amsterdam II Clinical Criteria (all criteria must be fulfilled) are the most stringent criteria for defining
families at 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 the age of 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, or  HNPCC, 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 years.
    • 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 less than 50 years old
  • Presence of synchronous or metachronous CRC or other HNPCC‒associated tumors,** regardless of age
  • CRC with high microsatellite instability histology diagnosed in a patient less than 60 years old
  • 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 50 years of age
  • 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.

  1. Genetic testing for BRAF V600E or MLH1 promoter methylation are established to exclude a diagnosis of Lynch syndrome when:
    • MLH1 protein isn’t expressed in a colorectal cancer tumor on immunohistochemical analysis.
  1. Genetic testing for SMAD4 and BMPR1A gene variants are 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.
  1. 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-riska relative of a patient suspected of or diagnosed with Peutz-Jeghers syndrome.

aDue 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 (i.e., siblings, parents and offspring) and second-degree (i.e., grandparents, aunts, uncles, nieces, nephews, grandchildren and half-siblings) 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.

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 impact 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 experimental 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.

81519, 81520, 81521

Experimental:
S3854, 0045U, 81518, 81522,84999

Basic benefit and medical policy

Genetic tests for the prognosis of breast cancer

The safety and effectiveness of the use of the 21-gene reverse transcriptase-polymerase chain reaction (RT-PCR) assay (i.e., Oncotype DX®, the EndoPredict®, the Breast Cancer IndexSM, MammaPrint and Prosigna™ tests) to determine recurrence risk for deciding whether or not to undergo adjuvant chemotherapy have been established. They are useful diagnostic tests for determining the likelihood of distant cancer recurrence in women for patients who meet the inclusionary guidelines.

The use of the 21-gene reverse transcriptase-polymerase chain reaction assay (e.g., Oncotype DX, the EndoPredict®, the Breast Cancer IndexSM, MammaPrint and Prosigna™ tests, this is not an all-inclusive list) to determine hormonal therapy after five years is considered experimental.

Other genetic testing for determining the likelihood of distant cancer recurrence in women is experimental (refer to exclusions below).

This policy has been updated effective July 1, 2020.

Inclusions (must meet all):

The use of Oncotype Dx, the EndoPredict, the Breast Cancer Index, MammaPrint and Prosigna tests to determine recurrence risk for deciding whether or not to undergo adjuvant chemotherapy may be considered established in women with breast cancer meeting all of the following characteristics:

  • Unilateral tumor
  • Hormone receptor-positive (that is, estrogen-receptor [ER] positive or progesterone-receptor [PR]-positive)
  • Human epidermal growth factor receptor (HER) 2-negative
  • Tumor size 0.6-1 cm with moderate/poor differentiation or unfavorable features OR tumor size larger than 1 cm
  • Node negative (lymph nodes with micrometastases [less than 2 mm in size] are considered node negative for this policy).
  • Who will be treated with adjuvant endocrine therapy, i.e., tamoxifen or aromatase inhibitors
  • When the test result will aid the patient in making the decision regarding chemotherapy (i.e., when chemotherapy is a therapeutic option)
  • When ordered within six months after diagnosis, since the value of the test for making decisions regarding delayed chemotherapy is unknown. 

Or
Use of multigene assay to assess prognosis and determine chemotherapy benefit for node-positive, ER+, HER2- breast cancer with pN1mi (≤2 mm axillary node metastasis) or N1 (<4 nodes) is established.

These tests should only be ordered on a tissue specimen obtained during surgical removal of the tumor and after subsequent pathology examination of the tumor has been completed and determined to meet the above criteria (i.e., the test should not be ordered on a preliminary core biopsy). The test should be ordered in the context of a physician-patient discussion regarding risk preferences when the test result will aid in making decisions regarding chemotherapy.

For patients who otherwise meet the above characteristics but who have multiple ipsilateral primary tumors, a specimen from the tumor with the most aggressive histological characteristics should be submitted for testing. It isn’t necessary to conduct testing on each tumor; treatment is based on the most aggressive lesion.

Exclusions:

  • Gene expression assays when used in tandem with other similar assays is considered investigational, only a single assay should be used (i.e., Oncotype DX and MammaPrint should not be ordered on the same patient).
  • Use of a subset of genes from the 21-gene RT-PCR assay for predicting recurrence risk in patients with noninvasive ductal carcinoma in situ (DCIS) (i.e., Oncotype DX DCIS) to inform treatment planning following excisional surgery is considered experimental.
  • The use of other gene expression assays (e.g., Mammostrat® Breast Cancer Test, the BreastOncPx™, NexCourse® Breast IHC4, BreastPRS™, etc.) for any indication is experimental.
  • The use of gene expression assays in men with breast cancer is considered experimental.
  • The use of gene expression assays to molecularly subclassify breast cancer (e.g., BluePrint®) is considered experimental.
The use of gene expression assays for quantitative assessment of ER, PR and HER2 overexpression (e.g., TargetPrint®) is considered experimental.

95004, 95017, 95018, 95024, 95027, 95028, 95044, 95052, 95056, 95070, 95071, 95076, 95079, 95115, 95117, 95120, 95125, 95130, 95131, 95132, 95133, 95134, 95144, 95145, 95146, 95147, 95148, 95149, 95165, 95170, 95180, 82785, 86001, 86003, 86005, 86008

Experimental/not covered:
86343, 95060, 95065, 95199, 30999

Basic benefit and medical policy

Allergy testing and immunotherapy treatment

The safety and effectiveness of selected allergy testing and immunotherapy treatment of allergies have been established. They may be considered useful diagnostic and therapeutic options when indicated.

Inclusionary and exclusionary criteria have been updated, effective July 1, 2020. 

Inclusions:

  • Allergy testing:
    • Bronchial challenge tests
    • Direct skin test (percutaneous [scratch, prick or puncture] or intracutaneous [intradermal])
    • Double-blind food challenge test
    • Patch test (application test)
    • Photo patch test
    • In vitro IgE antibody tests (RAST, MAST, FAST, ELISA, ImmunoCAP)
    • Total serum IgE concentration
    • Serial (skin) endpoint titration (S.E.T. also known as the Rinkel test) when there is a high likelihood for a severe allergic reaction to specific agents such as antibiotics, nuts or other high-risk allergens
  • Immunotherapy treatments:
    • Appropriate in patients with demonstrated allergic hypersensitivity that can’t be managed by medications or avoidance
    • Oral immunotherapy with Palforzia™, when Pharmacy and Therapeutics policy criteria are met

Exclusions:

  • Allergy testing (this list may not be all-inclusive)
    • Antigen leukocyte cellular antibody, or ALCAT, automated food allergy testing (see policy titled “Antigen Leukocyte Antibody Test”)
    • Applied kinesiology or Nambudripad’s allergy elimination test (NAET; i.e., muscle strength testing or measurement after allergen ingestion)
    • Anti-Fc Epsilon receptor antibodies testing
    • Anti-IgE receptor antibody testing
    • Blood, urine or stool micro-nutrient assessments
    • Candidiasis test
    • Chemical analysis of body tissues (e.g., hair)
    • Chlorinated pesticides (serum)
    • Clifford materials reactivity testing
    • Complement (total or components)
    • Complement antigen testing (Sage)
    • C-reactive protein
    • Cytokine and cytokine receptor assay
    • Cytotoxic food, environmental or clinical ecological tests (Bryan’s test, ACT)
    • Direct mucous membrane test (conjunctival/ophthalmic, nasal)
    • Electrodermal testing or electro-acupuncture
    • Electromagnetic sensitivity syndrome/disorder (allergy to electricity, electro-sensitivity, electro-hypersensitivity and hypersensitivity to electricity)
    • Environmental cultures and chemicals
    • Eosinophil cationic protein, or ECP, test
    • Food immune complex assay, or FICA, or food allergenic extract immunotherapy
    • General immune system assessments
    • Immune complex assay
    • Iridology
    • Leukocyte antibodies testing
    • Leukocyte histamine release test, or LHRT/basophil histamine release test
    • Live cell analysis
    • Lymphocytes (B or T subsets)
    • Lymphocyte function assay
    • Mediator release test or the LEAP program
    • Metabolic assessments
    • Multiple chemical sensitivity syndrome (a.k.a., idiopathic environmental intolerance, clinical ecological illness, clinical ecology, environmental illness, chemical AIDS, environmental/chemical hypersensitivity disease, total allergy syndrome, cerebral allergy, 20th century disease)
    • Nasal challenge test
    • Prausnitz-Kustner or P-K testing/passive cutaneous transfer test
    • Provocation tests for food or food additive allergies
    • Pulse response test
    • Qualification of nutritional assessments
    • Rebuck skin window test
    • Secretory IgA (saliva, and other mucous secretions)
    • Allergen specific IgG (RAST/ELISA) testing
    • Sublingual provocative neutralization testing and treatment with hormones
    • Venom blocking antibodies
    • Volatile chemical panels (blood testing for chemicals)
  • Immunotherapy:
    • Oral immunotherapy**
    • Oral mucosal immunotherapy, including compounded toothpaste
    • Provocation and neutralization therapy for food allergies, using intradermal and subcutaneous routes
    • Rinkel injection therapy, also known as serial dilution endpoint titration therapy, for ragweed pollen hay fever
    • Enzyme-potentiated desensitization
    • Repository emulsion therapy
    • Urine auto injections (autogenous urine immunization)
    • Rhinophototherapy

**Exception: Palforzia™, when Pharmacy and Therapeutics Policy criteria are met

95803

Basic benefit and medical policy

Actigraphy

The medical policy statement has been updated for the Actigraphy medical policy. This policy is effective July 1, 2020.

Medical policy statement

Actigraphy is considered experimental when used as the sole technique to record and analyze body movement including, but not limited to, its use in the evaluation of sleep disorders. There is insufficient scientific evidence in the current medical literature to indicate that this technology is as beneficial as the established alternatives.

Note: When used as a component of portable sleep monitoring, actigraphy should not be reported separately.

Established
97151, 97152, 97153, 97154, 97155,**
97156,*** 97157,*** 97158, H0031, H0032
H2014, H2019, S5108, S5111,*** 0362T, 0373T

**Program modification of ABA therapy may be used as a combination of face-to-face and telemedicine services up to 50% of the time – as long as a behavior technician is present face to face.

***Training/treatment guidance may be delivered via telemedicine.

Basic benefit and medical policy

Applied Behavior Analysis for Autism Spectrum Disorder policy

The criteria have been updated for the Applied Behavior Analysis for Autism Spectrum Disorder policy, effective July 1, 2020.

Medical policy statement

The effectiveness of applied behavior analysis in the treatment of autism spectrum disorder has been established. It may be a useful therapeutic option when inclusionary and certificate guidelines are met.

Refer to member’s certificate for benefit specific coverage guidelines.

Inclusions:

  • Full diagnostic criteria for autism spectrum disorder, as published in the most recent edition of the American Psychiatric Association’s “Diagnostic and Statistical Manual,” are met.
  • The maladaptive behavior must affect the child’s personal safety, the safety of others within the child’s environment or must significantly interfere with the child’s ability to function.
  • Services in Michigan must be provided or supervised by one of the following:
    • Clinician who is a licensed behavior analyst
    • Psychiatrist who has the appropriate training
    • Licensed psychologist who has the appropriate education, training and experience
    • Person who holds a license, certificate or registration that authorizes them to perform services included in applied behavior analysis
  • Services outside of Michigan must be provided by a clinician who meets their state requirements to provide ABA therapy.
    • There is a treatment plan that:
      • Is child centered
      • Defines target behaviors
      • Records objective measures of baseline levels and progress
      • Identifies and documents specific interventions and techniques
      • Documents transitional and discharge plans

Exclusions:

  • People who don’t meet the diagnostic criteria based on the most recent criteria by the American Psychiatric Association (i.e., most current version of the Diagnostic and Statistical Manual)
  • In Michigan, therapy delivered or supervised by clinicians who aren’t licensed behavior analysts or those who do not meet state requirements to provide ABA therapy
  • Outside of Michigan, therapy delivered or supervised by clinicians who don’t meet their state requirements to provide ABA therapy
  • Therapy for persons older than age 18
  • Therapy is excluded from telemedicine**

**Exceptions:

  • Parent, guardian or caregiver adaptive behavior treatment training may be performed as a telemedicine service.
  • Program modification of ABA therapy may be used as a combination of face-to-face and telemedicine services up to 50% of the time as long as a behavior technician is present face to face.
Note: Refer to the medical policy Telemedicine Services.

E0766, A4555, 95999

Not covered:
A9900, E1399, 77299

Basic benefit and medical policy

Effective tumor-treating fields therapy

The safety and effectiveness of tumor-treatment fields, known as TTF, therapy have been established. It’s a useful therapeutic option for patients meeting specific selection criteria.

The criteria have been updated, effective July 1, 2020. 

Inclusions:

Treatment of newly diagnosed, histologically confirmed supratentorial glioblastoma multiforme when the following criteria are met:

  • Adults (22 years and older) when one of the following apply:
    • Used as an adjunct therapy to standard treatments that include maximal debulking surgery and completion of radiation together with the chemotherapy drug temozolomide (TMZ)
    • Continued as maintenance therapy, after TMZ completion, in responsive tumors
    • Monotherapy as an alternative to standard medical therapy in the reoccurrence of histologically or radiologically confirmed supratentorial glioblastoma multiforme tumor

Exclusions:

Tumor treating field therapy with any of the following:

  • Combined with chemotherapy other than TMZ
  • As an adjunct to standard medical therapy (pemetrexed and platinum-based chemo-therapy) for patients with malignant pleural mesothelioma
  • When used for any indications other than those listed above

J2501

Basic benefit and medical policy

Zemplar

Effective Oct. 17, 2019, Zemplar, procedure code J2502, is payable for the new clarified FDA-approved indications.

Zemplar paricalcitol injection is a vitamin D analog. When used as indicated, for the prevention and treatment of secondary hyperparathyroidism in patients ages 5 and older with chronic kidney disease on dialysis.

J3490
J3590

Basic benefit and medical policy

Jynneos

Jynneos is a vaccine indicated for the prevention of smallpox and monkeypox disease in adults ages 18 and older determined to be at high risk for smallpox or monkeypox infection. Blue Cross Blue Shield of Michigan considers it an established treatment.

J3490
J3590

Basic benefit and medical policy

Scenesse

Scenesse is a melanocortin 1 receptor, or MC1-R, agonist. When used to treat a patient as indicated, to increase pain-free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria, or EPP, Blue Cross Blue Shield of Michigan considers it an established treatment.

J9312

Basic benefit and medical policy

Rituxan (rituximab)

Effective Sept. 27, 2019, Rituxan (rituximab) is payable for pediatric patients age 2 years and older for the following updated indication for granulomatosis with polyangiitis, or GPA, (Wegener’s granulomatosis) and microscopic polyangiitis, or MPA:

  • Granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis in adult and pediatric patients ages 2 years and older in combination with glucocorticoids.

Dosing:

The induction dose for pediatric patients with GPA and MPA in combination with glucocorticoids is 375 mg/m2 once weekly for four weeks. The follow-up dose for pediatric patients with GPA and MPA who have achieved disease control with induction treatment, in combination with glucocorticoids is two 250 mg/m2 intravenous infusions separated by two weeks, followed by a 250 mg/m2 intravenous infusion every six months thereafter based on clinical evaluation.

Pharmacy doesn’t require prior authorization of this drug.
EXPERIMENTAL PROCEDURES

22899**

**Unlisted code used to report device

Basic benefit and medical policy

Infuse/Mastergraft™ device

The use of a Infuse/Mastergraft™ posterolateral revision device is considered experimental. It hasn’t been scientifically demonstrated to be as safe and effective as conventional treatment. This policy is effective July 1, 2020. 

No portion of this publication may be copied without the express written permission of Blue Cross Blue Shield of Michigan, except that BCBSM participating health care providers may make copies for their personal use. In no event may any portion of this publication be copied or reprinted and used for commercial purposes by any party other than BCBSM.

*CPT codes, descriptions and two-digit numeric modifiers only are copyright 2019 American Medical Association. All rights reserved.