Policy Updates February 2016

Policies Status Details
Medical Coverage Policy
Unless otherwise noted, the following medical coverage policies were modified effective February 15, 2016:
Genetic Testing for Reproductive Carrier Testing and Prenatal Diagnosis - (0514) New
  • Contains new content and content from 19 existing medical coverage policies.
  • Policy statement updates - unknown if change in coverage:
    • Added not covered policy statement about noninvasive prenatal testing (NIPT) screening for trisomy 13, 18, and 21 performed at out-of-network laboratory when tests are available at in-network laboratory.
  • Policy statement updates with no change in coverage:
    • Added not covered policy statement for reproductive carrier screening for nonmedical traits (e.g., eye color, hair color).
    • Added not covered policy statement for gene sequencing for preimplementation genetic diagnosis (PGD).
    • Clarified coverage for noninvasive prenatal testing (NIPT) testing, to screen for fetal trisomy 13, 18, and 21.
      • Also clarified when NIPT is not covered.
    • Removed many specific gene and test names from policy and added them to the Genetic Testing Collateral File.
Strapping and Taping - (0512) New
  • Will be posted February 15, 2016 to provide advance notification to health care professionals.
  • Not effective until May 15, 2016.
  • Important changes in coverage beginning May 15, 2016:
    • Strapping codes are currently allowed without review.
      • New procedure to diagnosis (PXDX) edits will allow some strapping codes for specific diagnoses; while others will not be allowed for any diagnosis.
    • Elastic therapeutic tape/taping (e.g., Kinesio tape, KT TAPE/KT TAPE PRO, Spidertech tape) is not allowed for any indication.
      • Information already in Physical Therapy - (0096)
      • No specific CPT code for elastic therapeutic taping
      • Often billed with strapping codes
Tumor Profiling Gene Expression Assays and Molecular Diagnostic Testing for Hematology/Oncology Indications - (0520) New
  • Consolidates content from seven existing medical coverage policies.
  • Important changes in coverage:
    • Added general coverage principles for individual tumor biomarker testing, gene expression classifier testing and multigene panel testing; expanding criteria for coverage to include National Comprehensive Cancer Network (NCCN) recommendations.
    • Expanded coverage for Oncotype DX®.
    • Added coverage for mutation testing for polycythemia vera, essential thrombocytopenia, and primary myelofibrosis.
    • Expanded coverage to include BRAF testing.
    • Expanded coverage to include EGFR and/or ALK testing.
  • Policy statement updates with no change in coverage:
    • Added policy statement noting when molecular testing is not covered.
Allergy Testing and Non-Pharmacologic Treatment - (0070) Modified
  • Important changes in coverage:
    • Removed daily limit requirement on CPT code 95165.
      • ClaimsXten (CXT) will not allow both a daily and annual max on same claim.
    • Changed annual limit from 120 to 150 doses.
  • Policy statement updates with no change in coverage:
    • Updated first and second existing policy statements under the treatment section to match code description wording.
    • Changed "units" to "doses" to describe the individual amounts covered.
Atherosclerotic Cardiovascular Disease Risk Assessment: Emerging Laboratory Evaluations - (0137) Modified
Breast Reconstruction Following Mastectomy or Lumpectomy - (0178) Modified
  • Updates were previously posted on November 15, 2015 to provide advance notifcation to health care professionals of changes effective February 15, 2016.
  • Important change in coverage:
    • Moved SurgiMend® from covered to not covered
      • SurgiMend is not FDA approved for breast reconstruction.
Chiropractic Care - (0267) Modified
  • Policy statement updates with no change in coverage:
    • Removed part of existing policy statement about time/visit limit.
    • Clarified wording in existing not covered policy statement.
Colorectal Cancer Screening and Surveillance - (0148) Modified
Comparative Genomic Hybridization (CGH)/Chromosomal Microarray Analysis (CMA) for Autism Spectrum Disorders, Developmental Delay, Intellectual Disability, and Multiple or Unspecified Congenital Anomalies - (0493) Modified
Drug Testing - (0513) Modified
  • Policy statement update with no change in coverage:
    • Updated existing policy statement to reflect definition of units.
Genetic Testing Collateral File Modified
  • Existing supportive document, not a coverage policy:
    • Identifies individual genes and/or branded genetic tests (including panels) covered as medically necessary or considered experimental, investigational or unproven (EIU).
    • Identifies:
      • name of specific gene or genetic test
      • coverage position to which the indication applies
      • lab name (if known)
      • hyperlink to the related coverage policy
    • File is not all inclusive.
Genetic Testing for Hereditary and Multifactorial Conditions - (0052) Modified
  • Important changes in coverage:
    • Changed coverage for alpha anti-trypsin deficiency from not covered to covered.
    • Added new policy statement with more specific criteria for multigene, next-generation sequencing (NGS) panels for hereditary conditions.
    • Added new policy statement with more specific criteria for multigene, NGS panels, and panel testing for multifactorial conditions.
  • Policy statement updates - unknown if change in coverage:
    • Added new coverage criteria for laboratory testing.
    • Potentially changes coverage; depends on test requested.
    • Added not covered statement for out-of-network request to be covered at an in-network benefit level.
      • Each proposed test in a panel must not be available from an in-network laboratory for the indication(s) or diagnoses listed.
    • Potentially changes coverage; depends on test requested.
    • Policy statement updates with no change in coverage:
      • Consolidated content of 16 existing genetic testing-related coverage policies into this policy.
      • Changed focus of policy statements from specific indication-based to general principle-based.
      • Removed many specific gene and test names from policy and added them to the Genetic Testing Collateral File.
      • Revised benefit disclaimer in policy section to include mention of laboratory testing (along with genetic counseling and testing).
      • Added policy statement that NGS panels, panel testing for multifactorial diseases and multigene genetic testing panels are not covered.
Infertility Services - (0089) Modified
Invasive Treatment for Urinary Incontinence - (0365) Modified
  • Policy statement update with no change in coverage:
    • Clarified documentation requirement for percutaneous tibial nerve stimulation.
Pharmacogenetic Testing - (0500) Modified
Recurrent Pregnancy Loss: Diagnosis and Treatment - (0284)) Modified
Tissue-Engineered Skin Substitutes - (0068) Modified
  • Updates were previously posted on November 15, 2015 to provide advance notifcation to health care professionals of changes effective February 15, 2016.
  • Important change in coverage:
    • Moved SurgiMend® from covered to not covered
      • SurgiMend is not FDA approved for breast reconstruction.
Cardiac Event Monitors - (0805) Retired
  • Policy retired as of February 15, 2016.
Computed Tomography, Low-Dose for Lung Cancer Screening - (0007) Retired
Eighteen coverage policies were retired as part of the Genetic Testing Coverage Policy Consolidation project Retired
    • Gene-Based Testing for Prostate Cancer Screening, Detection, and Disease Monitoring - (0332)
    • Genetic Expression Assays for Breast Cancer Prognosis - (0298)
    • Genetic Testing for Alzheimer's Disease - (0392)
    • Genetic Testing for Canavan Disease - (0333)
    • Genetic Testing for Cystic Fibrosis - (0022)
    • Genetic Testing for Gaucher Disease - (0278)
    • Genetic Testing for Hemoglobinopathies - (0192)
    • Genetic Testing for Hereditary Hypercoagulability Disorders - (0255)
    • Genetic Testing for HFE-Associated Hereditary Hemochromatosis - (0279)
    • Genetic Testing for Mitochondrial Disorders - (0201)
    • Genetic Testing for Muscular Dystrophy and Spinal Muscular Atrophy - (0271)
    • Genetic Testing for Niemann-Pick Disease - (0299)
    • Genetic Testing for Nonsyndromic Hearing Loss and Deafness (DFNB1) - (0254)
    • Genetic Testing for Tay-Sachs Disease - (0059)
    • Preimplantation Genetic Diagnosis - (0108)
    • Sequencing-Based Trisomy Testing for Fetal Aneuploidy - (0211)
    • Topographic Genotyping - (0487)
    • Tumor Markers for Cancer - (0172)
  • The content of the eighteen retired policies was incorporated into some or all of the following coverage policies:
Genetic Counseling - (0297) Retired
  • Also retired as part of the Genetic Testing Coverage Policy Consolidation project
Policies Status Details
Pharmacy (Drugs, Vaccines, and Biologics) Policies
Unless otherwise noted, the following medical coverage policies were modified effective February 15, 2016:
Botulinum Therapy - (1106) Modified
  • Important changes in coverage:
    • Updated coverage for primary esophageal achalasia.
    • Expanded new upper limb spasticity criteria for new FDA-approved indications to Dysport and Xeomin®.
    • Clarified upper limb spasticity criteria for Botox to include thumb flexors.
    • Updated criteria for Botox migraine to read "Failure or inadequate response, contraindication per FDA label or documented intolerance"
Brand Name Drugs Not Covered Unless Approved Under Medical Necessity Review - Employer Group Plans: Value Prescription Drug List and Advantage Prescription Drug List - (1602) Modified
  • Important changes in coverage:
    • Removed triamcinolone from asthma and respiratory nasal sprays:
      • Drug is no longer available.
Natalizumab (Tysabri®) for Crohn's Disease - (6017) Modified
  • Important changes in coverage:
    • Modified criteria to state one preferred anti-tumor necrosis factor biologic therapy and removed the example product provided.
Oncology Medications - (1403) Modified
  • Important changes in coverage:
    • Added newly FDA approved oncology medications requiring either pharmacy prior authorization or medical precertification:
      • alectinib (Alecensa®) to the Oncology Medication Pharmacy Benefit table
      • bendamustine (Bendeka), elotuzumab (Empliciti) and necitumumab (Portrazza) to the Oncology Medication Medical Benefit table
Rituximab (Rituxan®) for Non-Oncology Indications - (5108) Modified
  • Important changes in coverage:
    • Modified criteria to state one preferred anti-tumor necrosis factor biologic therapy and removed the example product provided.
Step Therapy – (1109) Modified
  • Important changes in coverage:
    • Removed Belbuca from long-acting Opioid step therapy to support a pharmacy business determination.
    • Added newly FDA approved Vivlodex to NSAID step therapy category.
    • Added newly FDA approved Dyanavel XR to ADHD step therapy category.
    • Added language "Step Therapy for this drug class is not applicable at this time" to the comment section for the following drug classes: acute oral narcotics, asthma nebulizer solutions.
Step Therapy Individual and Family Plan - (1603) Modified
  • Important changes in coverage:
    • Removed Foradil and Maxair:
      • Drugs are no longer on the market.
Testosterone Undecanoate (Aveed) - (1503) Modified
  • Important changes in coverage:
    • Updated stem language: "Failure or inadequate response, contraindication per FDA label, or documented intolerance."
Vidolizumab (Entyvio®) - (1502) Modified
  • Important changes in coverage:
    • Added "not a candidate for" to step requirements to both indications for immunomodulator/corticosteroid and anti-tumor necrosis factor therapy.
      • Changed to account for any differences in product labeling (e.g., warnings/precautions) and to promote individual review of previously tried therapy).
    • Removed preferred product box to simplify criteria.
      • Noted "one" preferred anti-tumor necrosis factor therapy.
    • Added limited initial authorization of 6 months based on FDA recommendation to discontinue Entyvio if no benefit by week 14.
      • Reauthorization criteria limited to documentation of clinical beneficial response.
Policies Status Details
Administrative Policies
There were no administrative policy updates for January.
Policies Status Details
CareAllies Medical Necessity Guidelines
Various Modified Nineteen policies have been posted to the CareAllies Medical Necessity Guidelines (CAMNG).
Policies Status Details
Reimbursement Policies*
R18 Ambulance Services Modified
  • Important changes effective April 11, 2016:
    • Added requirement of ambulance modifiers for all non-emergent ambulance transportation.
    • Added language noting reimbursement for non-emergent ambulance transportation is limited to or from a hospital.
    • Updated list of non-reimbursable ancillary transportation ambulance services.
R25 Drug Testing Billing Requirements Modified
  • Important changes effective January 1, 2016:
    • Added new 2016 CMS codes for presumptive and definitive drug testing.
    • Added billing guidelines for new codes.
  • Important changes effective February 15, 2016:
    • Identified CPT codes that will no longer be accepted for definitive drug testing.
    • This change initially affects nonparticipating health care professionals only.
  • Important changes effective May 16, 2016:
    • Noted that the changes made for February 15, 2016 will apply to participating health care professionals on May 16, 2016.
R24 Omnibus Reimbursement Policy Modified
  • Important changes effective May 16, 2016:
    • Updated to note surgical trays (A4550) will no longer be paid.
      • Trays are considered incidental to all other services provided.
      • Change applies to all nonparticipating health care providers billing on HCFA and outpatient UB claim forms via ClaimsXten (CXT).
      • Change also applies to outpatient UB claims billed by participating facilities with percentage off charges (POC) contracts via prepay.
    • Updated to note drug convenience kits will no longer be paid.
      • All drugs should be billed separately.
      • Supplies in kits are not eligible for separate payment.
    • Removed electrocardiogram policy.
    • Removed Robotic Assisted Surgery policy
R04 - Robotic Assisted Surgery Modified
  • Important changes:
    • Added statement noting the policy applies to both HCFA and UB claim forms.
R08 - Unlisted Codes Modified
  • Important changes:
    • Notification for denial of drug kits with unlisted codes.
    • Each item in drug kits must be separately billed with appropriate, specific codes.
    • Coding tables removed.
Policies Status Details
Claim Editing Policies and Procedures ClaimsXten
No updates for February 2016
Policies Status Details
Policies with a Reduction in Coverage**
Breast Reconstruction Following Mastectomy or Lumpectomy - (0178)

SurgiMend® has not been approved for use in breast reconstruction by the Federal Drug Administration.

Therefore, claims for SurgiMend that are billed with HCPCS codes C9358 or C9360 will be denied as experimental, investigational, or unproven (EIU).

Tissue –Engineered Skin Substitutes - (0068)

These policies apply to health benefit plans administered by Cigna companies and are intended to provide guidance in interpreting certain standard Cigna benefit plans. Please note, the terms of a customer's particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these policies are based. For example, a customer's benefit plan document may contain a specific exclusion related to a topic addressed in a policy. In the event of a conflict, a customer's benefit plan document always supersedes the information in the policies.
In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including these policies and; 4) the specific facts of the particular situation. These policies relate exclusively to the administration of health benefit plans and are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

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**The following policy updates, effective February 15, 2016, will result in a reduction of coverage.