Policy Updates January 2016

Policies Status Details
Medical Coverage Policy
Unless otherwise noted, the following medical coverage policies were modified effective January 15, 2016:
Attention-Deficit/Hyperactivity Disorders (ADHD): Assessment and Treatment - (0231) Modified
  • Policy statement update with no change in coverage:
    • Added "brain training/cognitive programs/games" to existing not covered policy statement.
Gender Reassignment Surgery - (0266) Modified
  • Important change in coverage:
    • Changed second-stage phalloplasty from not covered to covered.
  • Policy statement updates with no change in coverage:
    • Removed criteria requiring active participation in a recognized gender identity treatment program.
    • Clarified definition of real-life experience.
Omnibus Codes - (0504) Modified
  • Important change in coverage
    • Changed tumor treatment fields (Optune) from not covered to covered.
  • Policy statement updates - unknown if change in coverage:
    • Added new 2016 codes as not covered:
      • 0397T - ERCP with optical microscopy
      • 0404T - transcervical uterine fibroid(s) ablation with ultrasound guidance, radiofrequency
      • 0408T-0418T - permanent cardiac contractility modulation system
      • 0424T-0436T - neurostimulator system for treatment of central sleep apnea.
  • Policy statement update with no change in coverage:
    • Removed codes 0302T-0307T
      • Codes are in Cardiac Event Monitors - (0085).
Total Ankle Arthroplasty/Replacement - (0285) Modified
  • Will be posted January 15, 2016, but not effective until April 15, 2016.
  • Policy statement updates with no change in coverage:
    • Clarified non-coverage of total ankle arthroplasty/replacement procedures customized to the individual
    • Clarified non-coverage of imaging associated with customized ankle replacement.
Transcatheter Ablation of Arrhythmogenic Foci in the Pulmonary Veins for the Treatment of Atrial Fibrillation - (0469) Modified
  • Important change in coverage:
    • Changed cryoablation/cryoballoon ablation from not covered to covered.
Ventricular Assist Devices (VADs) and Percutaneous Cardiac Support Systems - (0054) Modified
  • Policy statement updates - unknown if change in coverage:
    • Added new not covered policy statement noting contraindications to permanent VAD placement.
    • Added new policy statement covering humanitarian device exemption approved percutaneous VAD - the Impella RP System.
  • Policy statement update with no change in coverage:
    • Updated name of the EXCOR device.
Policies Status Details
Pharmacy (Drugs, Vaccines, and Biologics) Policies
Standard Prescription Drug List - (1601) New
  • New coverage policy – effective January 1, 2016.
  • Supports brand name drugs not covered unless approved under medical necessity review for customers using the Standard or Performance Prescription Drug List.
Value Prescription Drug List - (1602) New
  • New coverage policy – effective January 1, 2016.
  • Supports brand name drugs not covered unless approved under medical necessity review for customers using the Value or Advantage Prescription Drug List.
Step Therapy - Individual and Family Plan - (1603) New
  • New coverage policy – effective January 1, 2016.
  • Supports Step Therapy requirements for the 2016 Individual and Family Plans.
Effective January 1, 2016, new preferred products were updated in the following coverage policies. No other criteria changes were made.
Abatacept (Orencia) - (6112) Modified
  • Enbrel is now a preferred product for Value and Advantage Prescription Drug List plans (Employer Group plans) in addition to Humira
  • Humira is now a preferred product for Individual Family Plans for polyarticular juvenile idiopathic arthritis; for rheumatoid arthritis, Humira and Cimzia are preferred.
Anakinra (Kineret®) - (4063) Modified
  • Enbrel is now a preferred product for Value and Advantage Prescription Drug List plans (Employer Group plans) in addition to Humira
  • Humira is now a preferred product for Individual Family Plans for polyarticular juvenile idiopathic arthritis; for rheumatoid arthritis, Humira and Cimzia are preferred.
Anti-Tumor Necrosis Factor Therapy - (9014) Modified
  • Enbrel is now a preferred product for Value and Advantage Prescription Drug List plans (Employer Group plans) in addition to Humira for rheumatoid arthritis.
  • Humira is now a preferred product for Individual Family Plans in addition to Cimzia for rheumatoid arthritis.
Apremilast (Otezla®) - (1414) Modified
  • Enbrel is now a preferred product for Value and Advantage Prescription Drug List plans (Employer Group plans) in addition to Humira for rheumatoid arthritis.
  • Humira is now a preferred product for Individual Family Plans in addition to Cimzia for psoriatic arthritis.
Insulin Recombinant Human (Afrezza®) - (1506) Modified
  • Humalog® and Novolog® are preferred product requirements for Standard and Value Prescription Drug List Plans (Employer Group).
  • Humalog is the preferred product requirement for Value and Advantage Prescription Drug List Plans (Employer Group).
  • Apidra®* AND Humalog® are preferred product requirement for Individual Family Plans; Apidra may require prior authorization.
Natalizumab (Tysabri®) for Crohn's Disease - (6017) Modified
  • Humira is now the preferred product for all plans.
Rituximab (Rituxan®) for Non-Oncology Indications - (5108) Modified
  • Humira is now the preferred product for all plans for rheumatoid arthritis.
Secukinumab (Cosentyx) - (1512) Modified
  • Humira is now the preferred product for all plans.
Tocilizumab (Actemra®) - (1024) Modified
  • Enbrel is now a preferred product for Value and Advantage Prescription Drug List plans (Employer Group plans) in addition to Humira
  • Humira is now a preferred product for Individual Family Plans in addition to Cimzia in rheumatoid arthritis; Humira only for polyarticular juvenile idiopathic arthritis.
Tofacitinib (Xeljanz®) - (1410) Modified
  • Enbrel is now a preferred product for Value and Advantage Prescription Drug List plans (Employer Group plans) in addition to Humira.
  • Humira is now a preferred product for Individual Family Plans in addition to Cimzia.
Transmucosal Fentanyl (Abstral®, Actiq®, Fentora®, Lazanda, Subsys®) - (1018) Modified
  • Subsys is a preferred product requirement for Standard and Performance Prescription Drug List plans (Employer Group plans).
Ustekinumab (Stelara®) - (1017) Modified
  • Enbrel is now a preferred product for Value and Advantage Prescription Drug List plans (Employer Group plans) in addition to Humira for psoriatic arthritis.
Vedolizumab (Entyvio®) - (1502) Modified
  • Humira is now the preferred product for Employer Group plans
  • Humira is the preferred product for Individual Family Plans in ulcerative colitis (in addition to Cimzia for Crohn's disease).
The following drug and biologic coverage policies were modified or retired effective January 15, 2016:
Clotting Factors and Antithrombin - (8007) Modified
  • Important changes in coverage:
    • Added newly FDA approved clotting factor products:
      • Adynovate (antihemophilic factor [recombinant], pegylated)
      • Coagadex (Coagulation Factor X (Human)
Denosumab (Prolia® and Xgeva®) - (1212) Modified
  • Important changes in coverage:
    • Added documentation for failure, contraindication, or intolerance.
    • Expanded "contraindication" to "not a candidate for" to include information from the special populations section of oral bisphosphonates recommending against use in renal impairment.
    • Modified to list two separate does not cover statements for Prolia and Xgeva.
Hepatitis C Therapy - (1316) Modified
  • Important changes in coverage:
    • Added newly FDA approved Daklinza.
    • Updated existing criteria statements with "no prior treatment" requirements.
    • Updated all sections in accord with AASLD/IDSA guidance and supporting published literature.
    • Added experimental, investigational, unproven (EIU) uses for Olysio® (with PEG and Ribavirin) as other superior treatment regimens are available.
Lomitapide Mesylate (Juxtapid®), Mipomersen Sodium (Kynamro®) - (1507) Modified
  • Important changes in coverage:
    • Updated criteria stem with addition of sampling statement consistent with PCSK9 inhibitors (receipt of sample product does not satisfy criteria requirements).
    • Refined diagnosis criteria for homozygous FH to the structure detailed by the European Atherosclerosis Society.
    • Defined inadequate response with maximally tolerated lipid lowering therapy (LLT) and that use of Juxtapid and Kynamro will be adjunct to maximally tolerated LLT.
    • Added inadequate response, contraindication or intolerance to evolocumab (Repatha).
    • Added in prescriber specialty requirement.
    • Added initial approval duration of 6 months (based on duration of clinical trials – 26 weeks) and reauthorization criteria (for up to 1 year) of beneficial clinical response and use as adjunctive therapy (no adherence component).
Multiple Sclerosis Therapy - (1402) Modified
  • Important changes in coverage:
    • Removed step therapy requirements from Copaxone 40mg.
Oncology Medications - (1403) Modified
  • Important changes in coverage:
    • Added newly FDA approved oncology medications launched to the market and subject to pharmacy prior authorization or medical precertification:
      • Ninlaro® (ixazomib) - multiple myeloma
      • Tagrisso (osimertinib) - lung cancer
      • Darzalex (daratumumab) - multiple myeloma
Pharmacy Prior Authorization - (1407) Modified
  • Important changes in coverage:
    • Added newly FDA approved sacubitril/valsartan (Entresto) and Tasimelteon (Hetlioz)
    • Retired stand-alone Tasimelteon (Hetlioz) coverage policy 1402.
Quantity Limitations - (1201) Modified
  • Important changes in coverage:
    • Added newly FDA approved long-acting opioid Belbuca (buprenorphine).
Somatropin (Genotropin®, Humatrope®, Norditropin®, Nutropin®, Nutropin® AQ, Omnitrope®, Saizen®, Serostim®, Tev-Tropin®, Zorbtive®) - (4012) Modified
  • Important changes in coverage:
    • Updated approved indications to read "failure/inadequate response, contraindication per FDA label, or documented intolerance"
    • Clarified criteria for coverage for Russell-Silver Syndrome (RSS) children with small for gestational age (SGA)
      • Removed note about RSS that follows the "Small for Gestational Age (SGA) When all of the Following Criteria are Met" section.
      • Added specific language to the not covered section for "Growth Hormone Use in Children" noting when we will continue to not cover for RSS without SGA
    • Incorporated EIU indications into the not covered section for "Growth Hormone Use in Children" for:
      • Cystic fibrosis
      • Duchenne muscular dystrophy
      • Hypochondroplasia
      • Hypophosphatemic rickets
      • Spinal cord defects
Step Therapy - (1109) Modified
  • Important changes in coverage:
    • Removed Asthma Nebulizer Solutions from step therapy
    • Removed Abilify/Abilify Discmelt (brand only) from Atypical Antipsychotic agents
    • Removed Acute Oral Narcotics from step therapy
    • Moved Wellbutrin XL (brand only) in the SSRI/SNRI section from step 2 to step 3
    • Removed Testim from step 1
    • Added Testim and Natesto to step 2
    • Removed anticoagulant step therapy (warfarin, Xarelto)
    • Removed Byetta, Bydureon, Victoza, Trulicity from step therapy
    • Added long-acting opiates requiring step 1 generics and step 2 preferred brand before step 3 non-preferred brands:
      • Avinza®
      • Belbuca
      • Embeda®
      • Exalgo®
      • Hysingla® ER
      • Kadian®
      • MS Contin®
      • Opana ER®
      • Zohydro® ER
Tasimelteon (Hetlioz) - coverage policy 1412. Retired
Policies Status Details
Administrative Policies
There were no administrative policy updates for January.
Policies Status Details
CareAllies Medical Necessity Guidelines
Various Modified Seventeen policies have been posted to the CareAllies Medical Necessity Guidelines (CAMNG).
Policies Status Details
Reimbursement Policies*
R26 - Physician Interpretation and Report (I&R) Services New
  • New reimbursement policy:
    • Effective January 1, 2016.
    • Created for transparency purposes
    • Notes when we will separately reimburse for interpretation and report services when billed with an Evaluation & Management (E&M) code.
R12 - Facility Routine Services, Supplies and Equipment Modified
  • Important changes:
    • Moved policy from notification section
      • Expanded examples of catheters not eligible for reimbursement effective January 1, 2016.
HCPCS Modifier Policy - MHCPCS Modified
  • Important changes:
    • Added new modifiers CT, CP, ZA as informational only.
      • Modifiers are effective January 1, 2016.
      • Update does not impact reimbursement.
R24 - Omnibus Reimbursement Policy Modified
  • Important changes:
    • Added new code 0396T to the Computer-Assisted Navigation for Musculoskeletal Procedures policy.
      • Code is effective January 1, 2016.
      • Update does not change policy intent.
Policies Status Details
Claim Editing Policies and Procedures ClaimsXten
Code Edit Bulletin - February 2016 Modified
  • Important changes effective February 13, 2016:
    • ClaimsXten will be updated to First Quarter Knowledge Base content and NCCI Version 22.0 for all medical and behavioral claims we process.
Policies Status Details
Policies with a Reduction in Coverage**
Policies with a Reduction in Coverage – effective January 1, 2016**
Cardiac and Vascular Catheters and Guide Wires Modified

Consistent with our current Facility Services, Supplies and Equipment (R12) policy, we will not reimburse cardiac and vascular catheters and guide wires, regardless of the amount billed.


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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**Policies with a Reduction in Coverage – effective January 1, 2016