Oxford

December 2015

policy update bulletin

Medical & Administrative Policy Updates

UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice staff with a simple and predictable administrative experience. The Policy Update Bulletin was developed to share important information regarding Oxford® Medical and Administrative Policy updates.*

*Where information in this bulletin conflicts with applicable state and/or federal law, Oxford® follows such applicable federal and/or state law

Oxford

Oxford® Medical and Administrative Policy Updates

Overview

This bulletin provides complete details on Oxford® Medical and Policy Update Classifications Administrative Policy updates. The appearance of a service or New procedure in this bulletin indicates only that Oxford® has recently New clinical coverage criteria and/or documentation review requirements adopted a new policy and/or updated, revised, replaced or have been adopted for a service, procedure, test, or device retired an existing policy; it does not imply that Oxford® provides Updated coverage for the service or procedure. In the event of an An existing policy has been reviewed and changes have not been made inconsistency or conflict between the information provided in this to the clinical coverage criteria or documentation review requirements; bulletin and the posted policy, the provisions of the posted policy however, items such as the clinical evidence, FDA information, and/or will prevail. Note that most benefit plan documents exclude from list(s) of applicable codes may have been updated benefit coverage health services identified as investigational or unproven/not medically necessary. Physicians and other health Revised care professionals may not seek or collect payment from a An existing policy has been reviewed and revisions have been made to member for services not covered by the applicable benefit plan the clinical coverage criteria and/or documentation review requirements unless first obtaining the member’s written consent, Replaced acknowledging that the service is not covered by the benefit plan An existing policy has been replaced with a new or different policy and that they will be billed directly for the service. Retired A complete library of Oxford® Medical and Administrative The procedural codes and/or services previously outlined in the policy are Policies is available at OxfordHealth.com > Providers > no longer being managed or are considered to be proven/medically Tools & Resources > Medical Information > Medical and necessary and are therefore not excluded as unproven/not medically Administrative Policies. necessary services, unless coverage guidelines or criteria are otherwise documented in another policy

Note: The absence of a policy does not automatically indicate or imply Tips for using the Policy Update Bulletin: coverage. As always, coverage for a service or procedure must be  From the table of contents, click the policy title to be determined in accordance with the member’s benefit plan and any directed to the corresponding policy update summary. applicable federal or state regulatory requirements. Additionally, UnitedHealthcare reserves the right to review the clinical evidence  From the policy updates table, click the policy title to view a supporting the safety and effectiveness of a medical technology prior to complete copy of a new, updated, or revised policy. rendering a coverage determination.

2 Oxford® Policy Update Bulletin: December 2015 Oxford

Oxford® Medical and Administrative Policy Updates

In This Issue

Clinical Policy Updates Page NEW  Site of Service Guidelines for Certain Outpatient Surgical Procedures - Effective Jan. 1, 2016 ...... 7 UPDATED  Epidural Steroid and Facet Injections for Spinal Pain - Effective Dec. 1, 2015 ...... 9  Panniculectomy and Body Contouring Procedures - Effective Dec. 1, 2015 ...... 11  Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs - Effective Dec. 1, 2015 ...... 12  Specialty Medication Administration - Site of Care Review Guidelines - Effective Dec. 1, 2015 ...... 13  Vagus Nerve Stimulation - Effective Dec. 1, 2015 ...... 13  Virtual Upper Gastrointestinal Endoscopy - Effective Dec. 1, 2015 ...... 15 REVISED  Abnormal Uterine Bleeding and Uterine Fibroids - Effective Jan. 1, 2016 ...... 15  Bariatric Surgery - Effective Jan. 1, 2016 ...... 17  Breast Imaging for Screening and Diagnosing Cancer - Effective Jan. 1, 2016 ...... 20  Breast Repair/Reconstruction (Not Following a Mastectomy) - Effective Jan. 1, 2016 ...... 26  Cardiovascular Disease Risk Tests - Effective Jan. 1, 2016 ...... 28  Diabetes Medications - Effective Jan. 1, 2016 ...... 30  Diabetic Test Strips and Meters - Effective Jan. 1, 2016 ...... 32  Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Jan. 1, 2016 ...... 34  Drug Coverage Guidelines - Effective Jan. 1, 2016 ...... 34 o Abstral (Fentanyl) ...... 34 o Actiq (Fentanyl Citrate) ...... 34 o Ambien (Zolpidem Tartrate) ...... 35 o Ambien CR (Zolpidem Tartrate Extended-Release[ER]) ...... 35 o Androderm (Testosterone) ...... 35 o Androgel (Testosterone) ...... 35 o Arnuity Ellipta (Fluticasone Furoate) ...... 35 o Auryxia (Ferric Citrate) ...... 36 o Avinza (Morphine Sulface Extended Release) (Brand Only) ...... 36 o Axiron (Testosterone) ...... 36 o Bupropion (Generic Zyban) ...... 36 o Butrans (Buprenorphine) ...... 37 o Capecitabine (Generic Xeloda) ...... 37 o Cetirizine Solution (Generic Zyrtec) ...... 37

3 Oxford® Policy Update Bulletin: December 2015 Oxford

Oxford® Medical and Administrative Policy Updates

In This Issue

o Chantix (Varenicline Tartrate) ...... 37 o Colcrys (Colchicine) ...... 37 o Cordran 0.05% Cream (Clurandrenolide) ...... 38 o Cordran 0.05% Lotion (Flurandrenolide) ...... 38 o Cultivate (Fluticasone Propionate 0.05%) ...... 38 o Daklinza (Daclatasvir) ...... 39 o Daliresp (Roflumilast) ...... 39 o Differin 0.3% Gel ...... 39 o Embeda (Morphine/Naltrexone) ...... 39 o Esomeprazole Strontium ...... 39 o Evotaz (Atazanavir/Cobicistat) ...... 40 o Exalgo (Hydromorphone) ...... 40 o Exjade (Deferasirox) ...... 40 o Ferriprox (Deferiprone) ...... 41 o Fentora (Fentanyl Buccal) ...... 41 o Forteo (Teriparatide) ...... 41 o Fortesta (Testosterone): Gel ...... 41 o Glatopa (Glatiramer 20mg [Generic Copaxone]) ...... 41 o Glyxambi (Empagliflozin/Linagliptin) ...... 42 o Harvoni ™ (Ledipasvir/Sofosbuvir) ...... 42 o Hysingla ER (Hydrocodone Bitartrate) ...... 43 o Iressa (Gefitinib) ...... 43 o Jadenu (Defirasirox) ...... 44 o Juxtapid (Lomitapide) ...... 44 o Kadian (Morphine Sulfate Extended Release) ...... 45 o Karbinal ER (Carbinoxamine Maleate) ...... 46 o Kuvan (Sapropterin Dihydrochloride) ...... 46 o Kynamro (Mipomersen Sodium) ...... 46 o Lamictal ODT (Lamotrigine Orally Disintegrating Tablets) ...... 48 o Lazanda (Fentanyl Nasal Spray) ...... 50 o Lescol XL (Fluvastatin) ...... 50 o Livalo (Pitavastatin) ...... 50 o Mitigare (Colchicine) ...... 50 o MS Contin ...... 51 o Multaq (Dronedarone) ...... 51 o Natesto (Testosterone Nasal Gel) ...... 51 o Natpara (Parathyroid Hormone) ...... 52 o Nicotine OTC Products: Habitrol OTC, Nicoderm CQ OTC, Nicorette Gum OTC, Nicorette Lozenge OTC, Nicorette Mini-Lozenge OTC, Thrive Gum OTC, Thrive Lozenge OTC ...... 53 o Nicotrol Inhaler (Nicotine) ...... 53

4 Oxford® Policy Update Bulletin: December 2015 Oxford

Oxford® Medical and Administrative Policy Updates

In This Issue

o Nicotrol NS (Nicotine) ...... 53 o Nuvigil (Armodafinil) ...... 53 o Odomzo (Sonidegib) ...... 53 o Olysio (Simeprevir) ...... 54 o Oxycontin (Oxycodone Extended Release) ...... 54 o Oxycodone ER 12HR Tablet ...... 54 o Oxymorphone Extended Release ...... 55 o Procysbi (Cysteamine Bitartrate) ...... 55 o Provigil (Modafinil) (Brand and Generic) ...... 55 o Qudexy XR (Topiramate)...... 55 o Repatha (Evolocumab) ...... 57 o Solaraze (Diclofenac)...... 57 o Soolantra (Ivermectin) ...... 58 o Sovaldi (Sofosbuvir) ...... 58 o Striant (Testosterone) ...... 58 o Subsys (Fentanyl Sublingual Spray) ...... 58 o Targretin Gel (Bexarotene) ...... 59 o Technivie (Ombitasvir/Paritaprevir/Ritonavir) ...... 59 o Test Strips (Diabetic)...... 59 o Testim (Testosterone Gel) ...... 60 o Testosterone Topical Gel (Generic Vogelxo) ...... 60 o Testosterone Topical Gel (Manufacturer of Perrigo Israel) ...... 60 o Tirosint (Levothyroxine Sodium) ...... 60 o Uloric (Febuxostat) ...... 61 o Varubi (Rolapitant) ...... 61 o Viekira Pak (Ombitasvir, Paritaprevir (ABT-450) and Ritonavir) ...... 61 o Vogelxo (Testosterone) ...... 61 o Xeljanz (Tofacitinib) ...... 61 o Xifaxan (Rifaximin) ...... 61 o Xigduo XR (Dapagliflozin and Metformin HCL) ...... 62 o Zohydro ER (Hydrocodone Bitartrate Extended Release) ...... 62 o Zontivity (Vorapaxar) ...... 62 o Zovirax Ointment ...... 63 o Zubsolv (Buprenorphine/Naxolone) ...... 63 o Zyban (Bupropion) ...... 63 o Zydelig (Idelalisib) ...... 63 o Zyrtec (Cetirizine) Solution ...... 64  Genetic Testing for Hereditary Breast and/or Ovarian Cancer Syndrome (HBOC) - Effective Jan. 1, 2016 ...... 64  Glaucoma Surgical Treatments - Effective Jan. 1, 2016 ...... 72  Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion - Effective Jan. 1, 2016 ...... 73

5 Oxford® Policy Update Bulletin: December 2015 Oxford

Oxford® Medical and Administrative Policy Updates

In This Issue

 Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines - Effective Feb. 1, 2016 ...... 75  Lupron-Depot /Lupron-Depot Ped (Leuprolide Acetate) - Effective Jan. 1, 2016 ...... 79  Omnibus Codes - Effective Jan. 1, 2016 ...... 82  Prescription Drug Quantity Duration (QD) and Quantity Level Limitations (QLL) - Effective Jan. 1, 2016 ...... 85  Preventive Care Services - Effective Jan. 1, 2016 ...... 85  Proton Pump Inhibitors - Effective Jan. 1, 2016 ...... 91  Remicade (infliximab) - Effective Dec. 1, 2015 ...... 92  Sandostatin Lar Depot (Octreotide Acetate) - Effective Jan. 1, 2016 ...... 93  Specialty Medication Administration - Site of Care Review Guidelines - Effective Jan. 1, 2016 ...... 95 Administrative Policy Updates UPDATED  Orthopedic Services - Effective Jan. 1, 2016 ...... 97  Precertification Exemptions for Outpatient Services - Effective Jan. 1, 2016 ...... 98 REVISED  Site of Service Differential - Effective Jan. 1, 2016 ...... 101 Reimbursement Policy Updates NEW  Physical Medicine & Rehabilitation: Multiple Therapy Procedure Reduction - Effective Mar. 1, 2016 ...... 102 REVISED  Injection and Infusion Services - Effective Jan. 1, 2016 ...... 103  Maximum Frequency Per Day - Effective Jan. 1, 2016 ...... 105  Moderate Sedation - Effective Jan. 1, 2016 ...... 110  Supply Policy - Effective Jan. 1, 2016 ...... 113  Telemedicine Policy - Effective Jan. 1, 2016 ...... 116

6 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Site of Service Jan. 1, 2016 Introduction

Guidelines for In an effort to minimize out-of-pocket costs for Oxford members and to improve cost efficiencies for the overall Certain Outpatient health care system, we are implementing prior authorization guidelines that aim to encourage more cost-effective Surgical sites of service for certain outpatient surgical procedures, when medically appropriate. Procedures These prior authorization requirements apply to participating providers located in Connecticut (CT) and New York (NY) that are providing services to members enrolled on Oxford commercial products that require services to be medically necessary, as well as cost-effective. Refer to the enrollee specific benefit document to determine if medical necessity applies.

Note: This policy does not apply to participating providers located in New Jersey (NJ).

Coverage Rationale

With the exception of the qualifying conditions below, certain elective procedures should be performed in an

Ambulatory Surgical Center (ASC).

The following will be taken into account to determine whether the elective procedure is being performed in a cost

effective setting;

1. Members benefit plan

2. Geographic availability of an in network provider

3. Ambulatory surgical care (ASC) capability

4. Physician privileging

5. Significant member comorbidities

6. American Society of Anesthesiologist (ASA) physical status (PS), classification system

Potential Documentation Requirements

 Physician office notes  Physician privileging  ASA Score

Elective Procedures List

Prior authorization may be required for the following procedures to be performed in an outpatient hospital setting:  Abdominal Paracentesis  Carpal Tunnel Surgery  Cataract Surgery  Hernia Repair  Liver Biopsy  Tonsillectomy & Adenectomy

7 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Site of Service Jan. 1, 2016  Upper & Lower Gastrointestinal Endoscopy Guidelines for  Urologic Procedures Certain Outpatient Surgical Certain Qualifying Conditions

Procedures Some patients may require more complex care due to factors such as age or medical (continued) conditions. Also, some ASCs may have specific guidelines that prohibit members who are above a certain weight or have certain health conditions from receiving care in those facilities.

Patients with severe systemic disease and some functional limitation (ASA PS classification III or higher) may be appropriate to have the procedure in an outpatient hospital setting. Not an all-inclusive list.  Morbid Obesity (>BMI.40)  Diabetes (brittle diabetes*)  Resistant hypertension (poorly controlled**)  Chronic Obstructive Pulmonary Disease (COPD) (FEV1 < 50%)  Advance liver disease (MELD Score > 8***)  Alcohol dependence (at risk for withdrawal syndrome)  End stage renal disease (Hyperkalemia (above reference range**** peritoneal or hemodialysis)  Uncompensated Chronic Heart Failure (CHF) (NYHA class III or IV*****)  History of Myocardial Infarction (MI) (recent event [< 3 mo])  History of Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) (recent event [< 3 mo])  Coronary artery disease (CAD)/ Peripheral vascular disease (PVD) (ongoing cardiac ischemia requiring medical management recently placed drug eluting stent [within 1 year])  Sleep Apnea (moderate to severe Obstructive Sleep Apnea [OSA]******)  Implanted pacemaker  Personal history or family history of complication of anesthesia such as malignant hyperthermia  Pregnancy  Bleeding disorder requiring replacement factor or blood products or special infusion products to correct a coagulation defect (DDAVP is not blood product and is OK)  Prolonged surgery (>3 hrs)  Anticipated need for transfusion  Recent history of drug abuse (especially cocaine)  Patients with Drug Eluting Stents (DES) placed within one year or bear metal stents (BMS) or plain angioplasty within 90 days unless Acetylsalicylic Acid (ASA) and antiplatelet drugs will be continued by agreement of surgeon, cardiologist and anesthesia  Severe OSA for all surgery except peripheral surgery under local or peripheral nerve block (not plexus block) with no more than light sedation and not requiring post-op narcotics  Treated or untreated OSA for airway surgery (evidence of OSA may be secondary to sleep study with OSA

8 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

NEW Policy Title Effective Date Coverage Rationale Site of Service Jan. 1, 2016 described as moderate or severe or by history with an elevated STOP-BANG score see attachment) Guidelines for  Ongoing evidence of myocardial ischemia Certain Outpatient  Poorly controlled asthma (FEV1 < 80% despite medical management) Surgical  Significant valvular heart disease Procedures  Cardiac Arrhythmia (Symptomatic arrhythmia despite medication) (continued) Footnotes:

* (1) predominant hyperglycemia with recurrent ketoacidosis, (2) predominant hypoglycemia, and (3) mixed hyper- and hypoglycemia ** 3 or more drugs to control blood pressure *** http://reference.medscape.com/calculator/meld-score-end-stage-liver-disease Surgery in the Patient with Liver Disease, Friedman, L S. Trans Am Clin Climatol Assoc. 2010; 121: 192–205. **** https://www.kidney.org/sites/default/files/02-10-6785_HBE_Hyperkalemia_Bulletin.pdf ***** http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart- Failure_UCM_306328_Article.jsp ****** OSA

1. > 30 /hr as documented by PSG and documented inadequacy of treatment 2. Requirement of opioids post op 3. Upper airway surgery (Tonsillectomy & Adenectomy)

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Epidural Steroid Dec. 1, 2015  Modified format of lists of Epidural steroid injections in this policy apply to the lumbar spine and Facet applicable (reimbursable) ICD-10 only. This section does not address cervical injections. Injections for codes; updated table headers to Spinal Pain clarify listed codes are The facet joint injections section of this policy addresses multiple “proven/medically necessary” sites, and is not limited to the lumbar spine.

Oxford will provide coverage for epidural steroid and facet joint injections as outlined below and further subject to the CPT and ICD-9 diagnosis codes listed in the Payment Guidelines section.

The use of ultrasound guidance for epidural steroid injection(s) and facet joint injection(s) is unproven and not medically necessary. There is insufficient clinical evidence regarding its safety and/or efficacy in

9 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Epidural Steroid Dec. 1, 2015 published peer-reviewed medical literature. The available published evidence and Facet for ultrasound guidance for facet and epidural injections is limited to a small Injections for feasibility study and a cadaver study. Spinal Pain (continued) Epidural Steroid Injections  Epidural steroid injection proven and medically necessary when used for the treatment of acute and sub-acute sciatica or radicular pain of the low back caused by spinal stenosis, disc herniation or degenerative changes in the vertebrae. Epidural steroid injections have a clinically established role in the short- term management of low back pain when the following two criteria are met: o The pain is associated with symptoms of nerve root irritation and/or low back pain due to disc extrusions and/or contained herniations; and o The pain is unresponsive to conservative treatment, including but not limited to pharmacotherapy, exercise or physical therapy  Epidural steroid injection is unproven and not medically necessary for all other indications of the lumbar spine. There is a lack of evidence from randomized controlled trials indicating that epidural steroid injections effectively treat patients with lumbar pain not associated with sciatica or radicular pain.

Note: This policy does not apply to obstetrical epidural anesthesia utilized during labor and delivery.

Facet Joint Injections  Diagnostic facet joint injection and/or facet nerve block (e.g. medial branch block) is proven and medically necessary when used to localize the source of pain to the facet joint in persons with spinal pain.  Therapeutic facet joint injection is unproven and not medically necessary for the treatment of chronic spinal pain. Clinical evidence about the very existence of facet joint syndrome is conflicting, and evidence from studies is inadequate regarding the superiority of periodic facet joint injections compared to placebo in relieving chronic spinal pain (pain lasting more than 3 months).

10 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Epidural Steroid Dec. 1, 2015 Additional Information

and Facet Facet joint injection, as a diagnostic procedure prior to radiofrequency Injections for ablation, is not recommended in patients with: Spinal Pain  Neurologic abnormalities (continued)  More than one pain syndrome  Definitive clinical and/or imaging findings pointing to a specific diagnosis other than facet joint syndrome  Previous spinal surgery at the clinically suspected levels Panniculectomy Dec. 1, 2015  Updated reference link to Panniculectomy and Body applicable CMS Local Coverage Panniculectomy is considered reconstructive and medically Contouring Determination (LCD) to reflect necessary when the following criteria are present: Procedures new identification number a. Panniculus must hang below symphysis pubis; and assignment resulting from the b. The panniculus is the primary cause of skin conditions when present, such ICD-10 transition (effective Oct. a cellulitis requiring systemic antibiotics or transdermal skin ulcerations 1, 2015) that require medical treatment. c. There is presence of a functional impairment due to the panniculus; d. The surgery is expected to restore or improve the functional impairment; e. The panniculus is interfering with activities of daily living.

Note: o After significant weight loss not following bariatric surgery, in addition to the criteria listed above, there must be documentation that a stable weight has been maintained for six months. o After significant weight loss following bariatric surgery, in addition to meeting the criteria listed above there must be documentation that a stable weight has been maintained for six months. This often occurs 12-18 months after surgery.

Panniculectomy is not considered reconstructive and not medically necessary, and is not a covered service, in the following situations (not an all inclusive list): 1. When performed to relieve neck or back pain as there is no evidence that reduction of redundant skin and tissue results in less spinal stress or improved posture/alignment. 2. When performed in conjunction with abdominal or gynecologic surgery including but not limited to hernia repair, obesity surgery, C-section and hysterectomy unless the enrollee meets the criteria for panniculectomy as

11 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Panniculectomy Dec. 1, 2015 stated above in this document. and Body 3. Performed post childbirth in order to return to pre pregnancy shape. Contouring 4. Performed for intertrigo, a superficial inflammatory response or any other Procedures condition that does not meet the criteria above in this document. (continued) Documentation may be requested as part of the review, including but not limited to photographs and physician office notes.

Abdominoplasty

Abdominoplasty is not considered reconstructive or medically necessary, and is not a covered service, in the following situations (not an all-inclusive list): 1. Performed post childbirth in order to return to pre-pregnancy shape 2. Performed for diastasis recti 3. When performed in conjunction with abdominal or gynecologic surgery including but not limited to hernia repair, obesity surgery, C-section and hysterectomy 4. No documentation of a physical and/or physiological impairment

Lipectomy

Lipectomy is not considered reconstructive or medically necessary, and is not a covered service in the following situation (not an all- inclusive list): 1. Performed on any site including buttocks, arms, legs, neck, abdomen and medial thigh

Suction Assisted Lipectomy of the Trunk

Suction Assisted Lipectomy of the Trunk (CPT code 15877) is not considered reconstructive (unless part of an approved procedure) or medically necessary, and is not a covered service. For post-mastectomy patients, please refer to the policy titled Breast Reconstruction Post Mastectomy. Prosthetic Devices, Dec. 1, 2015  Updated reference links to Refer to the policy for complete details on the coverage guidelines for Wigs, Specialized, applicable CMS Local Coverage Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs. Microprocessor or Determinations (LCDs) to reflect Myoelectric Limbs new identification numbering resulting from the ICD-10 transition (effective Oct. 1, 2015)

12 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Specialty Dec. 1, 2015  Updated supporting Introduction

Medication information/clinical evidence; This policy addresses the criteria for consideration of allowing hospital Administration - removed language pertaining to outpatient facility specialty medication infusion service and claim submission Site of Care Review the ACR Practice Management for hospital based services with CMS/AMA Place of Service code 22 Guidelines Drug Safety on Remicade Outpatient Hospital. Alternative sites of care, such as non-hospital outpatient infusion, physician office, ambulatory infusion or home infusion services are well accepted places of service for medication infusion therapy. If a patient does not meet criteria to for outpatient hospital facility infusion, alternative sites of care may be used.

This policy applies to these specialty medications that require healthcare provider administration:  Abatacept (Orencia®)  Eculizumab (Soliris®)  Infliximab (Remicade® lyophilized concentrate for intravenous use)  Tocilizumab (Actemra® injection for intravenous use)  Vedolizumab (Entyvio®)

Medical Necessity Criteria for Site of Care Selection

Outpatient hospital facility-based intravenous medication infusion is

medically necessary for Members who meet any of the following

criteria:

 Medically unstable based upon submitted clinical history; or

 Initial medication infusion of or re-initiation after more than 6 months

following discontinuation of therapy; or

 Previous experience of a severe adverse event following infusion.

Examples include but are not limited to anaphylaxis, seizure,

thromboembolism, myocardial infarction, renal failure; or

 Continuing experience of adverse events that cannot be mitigated by pre-

medications; or

 Physically and/or cognitively impaired and no home caregiver available.

Additional information: Medical necessity criteria for administration of

intravenous infusion therapy at home are addressed in MCG™ Care

Guidelines, 19th edition, 2015, Home Infusion Therapy, CMT: CMT-

0009(SR). Vagus Nerve Dec. 1, 2015  Updated coverage rationale; Vagus nerve stimulation (VNS) is proven and medically necessary for Stimulation reformatted list of treating epilepsy in patients with all of the following:

13 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Vagus Nerve Dec. 1, 2015 proven/medically necessary  Medically refractory epileptic seizures Stimulation indications  The patient is not a surgical candidate or has failed a surgical intervention (continued)  Updated list of applicable HCPCS  No history of left or bilateral cervical vagotomy codes; removed L8681  Updated supporting information The U.S. Food and Drug Administration (FDA) identifies a history of left or to reflect the most current clinical bilateral cervical vagotomy as a contraindication to vagus nerve stimulation. evidence, FDA information, and references It is an expectation that the physician have experience and expertise in the use of vagus nerve stimulation.

Vagus nerve stimulation is unproven and not medically necessary for treating all other indications, including but not limited to the following:

 Alzheimer's disease  Anxiety disorder  Autism spectrum disorder  Back and neck pain  Bipolar disorder  Bulimia  Cerebral palsy  Chronic pain syndrome  Cluster headaches  Depression  Fibromyalgia  Heart failure  Migraines  Morbid obesity  Narcolepsy  Obsessive-compulsive disorder  Paralysis agitans  Sleep disorders  Tourette's syndrome

Available studies on the use of vagus nerve stimulation for treating severe, major depression or bipolar disorder refractory to medical therapy contain methodological flaws such as lack of control group, small sample size, potential bias, lack of randomization and blinding and lack of statistical power analysis. There is a substantial placebo effect associated with

14 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Coverage Rationale Vagus Nerve Dec. 1, 2015 depression treatments and the lack of data from prospective randomized Stimulation controlled or comparative clinical studies considerably limits the conclusions (continued) that can be drawn from the available evidence. Furthermore, preliminary analysis of a randomized controlled trial did not find a statistically significant difference between sham and active VNS. Definitive patient selection criteria for vagus nerve stimulation (VNS) in patients with treatment-resistant depression have not yet been established, and significant predictors of response have also not been identified.

Early research has examined the use of vagus nerve stimulation for additional indications. However, because of limited studies, small sample sizes and weak study designs, there is insufficient data to conclude that vagus nerve stimulation is safe and/or effective for treating these indications. Virtual Upper Dec. 1, 2015  Removed “Additional Products” Virtual upper gastrointestinal endoscopy is unproven and not Gastrointestinal information listing specific device medically necessary for the detection and evaluation of upper Endoscopy names and manufacturers gastrointestinal lesions.  Updated supporting information to reflect the most current clinical There is insufficient clinical data from the peer-reviewed published medical evidence and references; no literature to conclude that virtual upper gastrointestinal endoscopy is change to coverage rationale or effective for detecting and evaluating upper gastrointestinal lesions. A limited list of applicable codes number of studies of virtual upper gastrointestinal endoscopy have been published. Most studies involve a small number of patients and lack definitive patient selection criteria. Many of the studies have a serious shortcoming in that they assessed patients who were known or strongly suspected to have cancer or other upper gastrointestinal (GI) lesions. As a result, these studies may have overestimated the sensitivity of virtual endoscopy for gastric cancer detection, Randomized controlled studies comparing virtual upper GI endoscopy to conventional upper GI endoscopy are needed.

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Abnormal Uterine Jan. 1, 2016  Revised coverage rationale; Levonorgestrel-Releasing Intrauterine Device Bleeding and added language to indicate  The Mirena© (52 mg) levonorgestrel-releasing intrauterine device Uterine Fibroids transcervical ultrasound-guided (LNG-IUD) is proven and medically necessary for treating radiofrequency ablation is menorrhagia in premenopausal women. investigational, unproven and not  The Skyla® (13.5 mg) LNG-IUD is unproven and not medically medically necessary for treating necessary for treating menorrhagia. uterine fibroids due to lack of

15 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Abnormal Uterine Jan. 1, 2016 FDA approval There is insufficient clinical evidence in the published peer-reviewed Bleeding and  Updated list of applicable CPT & medical literature demonstrating the safety and/or efficacy of this device Uterine Fibroids HCPCS codes to reflect annual for treating menorrhagia. (continued) code edits (effective Jan. 1, 2016): See the FDA section of this policy for additional information. o Added 0404T, J7297 and J7298 Uterine Fibroids o Removed J7302  Uterine artery embolization (UAE) is proven and medically  Updated supporting information necessary for treating symptomatic uterine fibroids for women to reflect the most current who do NOT wish to preserve their childbearing potential. For description of services, clinical information regarding medical necessity review, when applicable, see evidence and references MCG™ Care Guidelines, 19th edition, 2015, Uterine Artery Embolization, ACG: A-0287 (AC).  Uterine artery embolization (UAE) is unproven and not medically

necessary for treating symptomatic uterine fibroids for women who wish to preserve their childbearing potential. The effects of

UAE on ovarian and uterine function and on fertility are relatively unknown. Further studies of safety and/or efficacy in published, peer-

reviewed medical literature are necessary.  Magnetic resonance imaging (MRI)-guided cryoablation is unproven and not medically necessary for treating uterine

fibroids. The published evidence on MRI-guided cryoablation for uterine fibroids is very limited, as the procedure has been evaluated in very few

patients. The long-term outcomes and overall health benefits remain unknown. Further long-term studies on larger samples published in peer- reviewed medical literature are necessary to demonstrate the safety and efficacy of this technology.  Magnetic resonance imaging (MRI)-guided focused ultrasound ablation (FUA) is unproven and not medically necessary for treating uterine fibroids. Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative to other treatment options for uterine fibroids. See the Benefit Considerations section of the policy for potential coverage of unproven services.  Laparoscopic ultrasound-guided radiofrequency ablation is unproven and not medically necessary for treating uterine fibroids. Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure

16 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Abnormal Uterine Jan. 1, 2016 relative to other treatment options for uterine fibroids. Bleeding and  Transcervical ultrasound-guided radiofrequency ablation is Uterine Fibroids investigational, unproven and not medically necessary for treating (continued) uterine fibroids due to lack of FDA approval. Further studies are needed to determine the long-term efficacy of this procedure and to evaluate the efficacy and safety of this procedure relative to other treatment options for uterine fibroids.

Bariatric Surgery Jan. 1, 2016  Revised conditions of Note: Gastric electrical stimulation with an implantable gastric stimulator coverage/special considerations: (IGS) for the treatment of obesity is addressed in this policy. For information o Updated list of applicable CPT regarding other indications, refer to Gastrointestinal Motility Disorders, codes requiring medical Diagnosis and Treatment. director review; added 43210 and 0317T Required Documentation for Medical Director Review:  Updated list of applicable/non-  Office notes including medical history and/or a letter of medical necessity. reimbursable CPT codes to reflect annual code edits (effective Jan. The following bariatric surgical procedures are proven and medically 1, 2016); added 43210 necessary in adults for the treatment of clinically severe obesity as  Updated supporting information defined by the National Heart Lung and Blood Institute (NHLBI): to reflect the most current  Gastric bypass (Roux-en-Y; gastrojejunal anastomosis) description of services, clinical  Adjustable gastric banding (laparoscopic adjustable silicone gastric evidence, FDA information and banding) – See FDA section/information of this policy references  Gastric sleeve procedure (also known as laparoscopic vertical gastrectomy or laparoscopic sleeve gastrectomy)  Vertical banded gastroplasty (gastric banding; gastric stapling)  Biliopancreatic bypass (Scopinaro procedure)  Biliopancreatic diversion with duodenal switch

Bariatric surgery using one of the procedures identified above (primary, secondary or revisions), as a treatment for weight loss is medically necessary when all of the following criteria are met:  Class III obesity, clinically severe [body mass index (BMI) > 40 kg/m2] OR  Class II obesity (BMI 35-39.9 kg/m2) in the presence of one or more of the following co-morbidities: o Type 2 diabetes; or o Cardiovascular disease (e.g., stroke, myocardial infarction, poorly controlled hypertension (systolic blood pressure greater than 140 mm Hg or diastolic blood pressure 90 mm Hg or greater, despite

17 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Bariatric Surgery Jan. 1, 2016 pharmacotherapy); or (continued) o History of coronary artery disease with a surgical intervention such as cardiopulmonary bypass or percutaneous transluminal coronary angioplasty; or o Cardiopulmonary problems (e.g., documented obstructive sleep apnea (OSA) confirmed on polysomnography with an AHI or RDI of >= 30 (as defined by AASM Task Force Sleep.1999;22:667-89); or o History of cardiomyopathy; and  The individual must also meet the following criteria: o Documentation of a motivated attempt of weight loss through a structured diet program, prior to bariatric surgery, which includes physician or other health care provider notes and/or diet or weight loss logs from a structured weight loss program for a minimum of 6 months. (NHLBI, 1998); and o Psychological evaluation to rule out major mental health disorders which would contraindicate surgery and/or undermine patient compliance with post-operative follow-up care and nutrition guidelines. (NHLBI, 1998)

The bariatric surgical procedures identified above are medically necessary in adolescents for the treatment of clinically severe obesity as defined by the National Heart Lung and Blood Institute (NHLBI) and who have:  Achieved greater than 95% of estimated adult height based on documented individual growth pattern; and  A minimum Tanner stage of 4 ; and  Meets medical necessity criteria noted above for adults

Note: See additional information in description of services section of the policy for growth and BMI charts.

Bariatric surgical procedures in a person who has not attained an adult level of physical development and maturation are unproven and not medically necessary. Potential safety issues must be addressed in studies with sufficient sample size and adequate follow-up times necessary to demonstrate the impact of the surgery on physical, sexual and reproductive maturation and the long term improvement of co-morbidities in this age group.

18 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Bariatric Surgery Jan. 1, 2016 Bariatric surgery to treat gynecological abnormalities, osteoarthritis, (continued) gallstones, urinary stress incontinence, gastroesophageal reflux (including for Barrett’s esophagus or gastroparesis) or other obesity associated diseases that generally do not lead to life threatening consequences is unproven and not medically necessary.

There is insufficient published clinical evidence to support bariatric surgery for the definitive treatment of gynecological abnormalities, osteoarthritis, gallstones, urinary stress incontinence or as a treatment for gastroesophageal reflux and other obesity associated diseases. Bariatric surgery will frequently ameliorate symptoms of co-morbidities such as gastroesophageal reflux disease and obstructive sleep apnea. However, the primary purpose of bariatric in obese person’s surgery is to achieve weight loss.

Robotic assisted* gastric bypass surgery is proven and medically necessary as equivalent but not superior to other types of minimally invasive bariatric surgery.

*For additional information, refer to the Reimbursement Policy titled Robotic Assisted Surgery.

Surgical adjustment or alteration of a prior bariatric procedure is proven and medically necessary for complications of the original surgery, such as stricture, obstruction, pouch dilatation, erosion, or band slippage when the complication causes abdominal pain, inability to eat or drink or causes vomiting of prescribed meals.

The following procedures are unproven and not medically necessary for the treatment of obesity:  Transoral endoscopic surgery  Mini-gastric bypass (MGB) or Laparoscopic Mini-gastric bypass (LMGBP)  Gastric electrical stimulation with an implantable gastric stimulator (IGS)  VBLOC® vagal blocking therapy  Intragastric balloon  Laparoscopic greater curvature plication, also known as total gastric vertical plication

Further studies are needed to determine the safety and efficacy of these

19 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Bariatric Surgery Jan. 1, 2016 procedures as a treatment option for obesity. (continued) Gastrointestinal liners (EndoBarrier®) are investigational, unproven and not medically necessary as a treatment for obesity. Gastrointestinal liners have not received FDA approval. Their long-term efficacy has not been demonstrated. Breast Imaging for Jan. 1, 2016  Updated benefit considerations Important Note: Oxford has engaged eviCore Healthcare to perform initial Screening and language to indicate the federal reviews of requests for pre-certification and Medical necessity reviews Diagnosing Cancer Patient Protection and Affordable (Oxford continues to be responsible for decisions to limit or deny coverage Care Act (PPACA) follows the and for appeals). Grade B recommendation of the US Preventive Services Task All pre-certification requests are handled by eviCore Healthcare. To pre- Force, and requires preventive certify a radiology procedure, please call eviCore Healthcareat 1-877-PRE- benefit coverage for screening AUTH (1-877-773-2884) or log onto the eviCare Healthcare web page at mammography for women over www.evicore.com. age 40  Revised coverage rationale: eviCore has established an infrastructure to support the review, o Added language to indicate if development, and implementation of comprehensive outpatient imaging service is “proven” or criteria. The radiology evidence-based guidelines and management criteria “unproven” to applicable are available on the eviCore Healthcare web site: www.evicore.com. medically necessary/not medically necessary statement Please refer to Radiology Procedures Requiring Precertification for eviCore o Added language to indicate Healthcare Arrangement for applicable CPT/HCPCS codes and additional computer-aided tactile breast requirements, if applicable. imaging is unproven and not medically necessary Breast Imaging as an Adjunct to Mammography . Clinical evidence is Digital mammography is proven and medically necessary for patients insufficient to determine with dense breast tissue. whether tactile breast imaging improves Breast Magnetic Resonance Imaging (MRI) outcomes for the screening Breast magnetic resonance imaging (MRI) is proven and medically or diagnosis of breast necessary for patients at high risk for breast cancer as defined as cancer having any of the following: . Future research should  Personal history of atypical breast histologies include better-designed  Family history or genetic predisposition for breast cancer studies, including  Prior therapeutic thoracic radiation therapy comparative, prospective  Dense breast tissue with any one of the following risk factors: and randomized controlled o Lifetime risk of breast cancer of ≥20%, according to risk assessment

20 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Breast Imaging for Jan. 1, 2016 trials evaluating this tools based on family history Screening and technology o Personal history of BRCA1 or BRCA 2 gene mutations Diagnosing Cancer  Updated list of applicable CPT o First-degree relative with a BRCA 1 or BRCA 2 gene mutation but no (continued) codes to reflect annual code edits having had genetic testing themselves (effective Jan. 1, 2016): o Prior therapeutic thoracic radiation therapy between ages of 10-30 o Added 0422T o Personal history of Li Fraumeni Syndrome, Cowden syndrome or o Revised description for 77057 Bannayan-Riley-Ruvalcaba syndrome or a first-degree relative with  Updated supporting information one of these syndromes. to reflect the most current description of services, clinical Breast magnetic resonance imaging (MRI) is unproven and not evidence, FDA information and medically necessary for patients with dense breast tissue not references accompanied by defined risk factors as described above.

Digital Breast Tomosynthesis (3-D Mammography) Digital tomosynthesis is unproven and not medically necessary for the screening and diagnosis of breast cancer. There is insufficient evidence to conclude that digital tomosynthesis of the breast is effective for the screening or diagnosis of breast cancer. Clinical evidence has not yet demonstrated that digital breast tomosynthesis used as an adjunct to standard mammography reduces the mortality rate from breast cancer.

Magnetic Resonance Elastography of the Breast Magnetic resonance elastography (MRE) is unproven and not medically necessary for breast cancer screening or diagnosis. There is insufficient evidence to conclude that MRE of the breast is effective for the screening or diagnosis of breast cancer. While data from small feasibility studies indicate that MRE may have some ability to discriminate between cancerous tissue and normal breast tissue or benign lesions based on tissue stiffness, there was overlap in values, and the diagnostic accuracy of MRE for detection of breast cancer remains to be determined. There are no definitive patient selection criteria for MRE for breast cancer detection.

Breast Specific Gamma Imaging (Scintimammography)

Scintimammography is unproven and not medically necessary for

breast cancer screening or diagnosis.

There is insufficient evidence that this diagnostic modality can differentiate

benign from malignant breast lesions. Based on the evidence, the role of

21 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Breast Imaging for Jan. 1, 2016 scintimammography remains unclear since this technology has not been Screening and shown to be accurate enough to screen for breast cancer or allow a confident Diagnosing Cancer decision to defer biopsy. (continued) Electrical Impedance Scanning (EIS) Electrical impedance scanning (EIS) is unproven and not medically necessary for the detection of breast cancer. There is insufficient evidence that EIS is effective in detecting malignant breast tissue. Evaluation of sensitivity and negative predictive value for EIS is inconsistent. Well-designed studies are needed to determine whether or not EIS is effective as an adjunct to mammography or provides a positive clinical benefit.

Computer Aided Detection for MRI of the Breast Computer-aided detection (CAD) is unproven and not medically necessary as an aid for radiologists to interpret contrast-enhanced magnetic resonance imaging (MRI) of the breast. Clinical evidence has not yet demonstrated that CAD improves patient outcomes or reduces breast cancer mortality when added to contrast- enhanced MRI. There is insufficient evidence to assess whether the use of CAD systems would maintain or increase the sensitivity, specificity, and recall rates of MRI of the breast. Prospective, well-designed and executed studies are needed to determine whether or not the use of CAD provides a positive clinical benefit.

Breast Ultrasound

Breast ultrasound is unproven and not medically necessary for

routine breast cancer screening including patients with dense breast

tissue. Clinical evidence has not yet demonstrated that routine use of

ultrasonography as an adjunct to screening mammography reduces

the mortality rate from breast cancer.

Breast ultrasound is medically necessary as an aid for radiologists to localize

breast lesions and in guiding placement of instruments for cyst aspiration

and percutaneous breast biopsies.

Computer Aided Detection for Ultrasound

Computer-aided detection (CAD) is unproven and not medically necessary as an aid for radiologists to detect breast cancer during

22 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Breast Imaging for Jan. 1, 2016 ultrasound. Screening and Clinical evidence has not yet demonstrated that CAD improves patient Diagnosing Cancer outcomes or reduces breast cancer mortality when added to (continued) ultrasonography. Future research should include better-designed studies, including prospective studies and randomized controlled trials evaluating this technology in large numbers of screening ultrasounds.

Computer Aided Tactile Breast Imaging Computer-aided tactile breast imaging is unproven and not medically necessary. Clinical evidence is insufficient to determine whether tactile breast imaging improves outcomes for the screening or diagnosis of breast cancer. Future research should include better-designed studies, including comparative, prospective and randomized controlled trials evaluating this technology.

Automated Breast Ultrasound Automated breast ultrasound is unproven and not medically necessary. Clinical evidence is insufficient to determine whether automated breast ultrasound improves the detection rate of breast cancer compared to screening mammography. Future research should include better-designed studies, including prospective studies and randomized controlled trials evaluating this technology.

Refer to the eviCore Healthcare Evidence Based Imaging Guidelines - Oxford for:  Magnetic resonance imaging (MRI) of the breast  3D rendering of computed tomography, magnetic resonance imaging or other tomographic modalities Breast Jan. 1, 2016  Revised conditions of Indications for Coverage

Reconstruction Post coverage/special considerations; Breast reconstruction is covered for Members who have a mastectomy Mastectomy added language to indicate: with or without a diagnosis of cancer. Mastectomy includes partial o Precertification is required for (lumpectomy, tylectomy, quadrantectomy, and segmentectomy), simple, services covered under the and radical. This benefit does not include aspirations, biopsy (open or Member's General Benefits core), excision of cysts, fibroadenomas or other benign or malignant package when performed in tumors, aberrant breast tissue, duct lesions, nipple or areolar lesions, or the office of a participating treatment of gynecomastia. provider

23 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Breast Jan. 1, 2016 o For Commercial plans, There is not a time frame in which the Member is required to have the Reconstruction Post precertification is not required, reconstruction done post mastectomy under the Women’s Health and Mastectomy but is encouraged for out-of- Cancer Rights Act of 1998. (continued) network services performed in In accordance with Federal and State mandates the following services are the office that are covered covered: under the Member's General  Reconstruction of the breast on which the mastectomy was performed Benefits package; if  Surgery and reconstruction of the other breast to produce a symmetrical precertification is not appearance, including nipple tattooing obtained, Oxford may review  Prosthesis (Implanted and/or external) for medical necessity after the  Treatment of physical complications of mastectomy, including service is rendered lymphedema  Revised coverage rationale/indications for Various surgical techniques are used for breast reconstruction, including coverage; but not limited to: o Updated list of services  Insertion of FDA approved breast implants and tissue expanders covered in accordance with  Breast Implants and tissue expanders post mastectomy with or without federal/state mandate; skin substitutes, approved by the FDA, including but not limited to: replaced “prosthesis Alloderm, Allomax or FlexHD are a covered benefit (implanted or external)” with  Transverse Rectus Abdominus Myocutaneous Flap (TRAM) “prosthesis (Implanted  Latissimus Dorsi Flap (LD) and/or external)”  Deep Inferior Epigastric Perforator (DIEP) Flap o Added language to indicate  Gluteal Flap (GAP free flap) breast reconstruction may be covered under certain Refer to the Definitions section for breast reconstruction procedure circumstances for the surgical definitions. treatment of gender dysphoria (refer to the enrollee specific If the original implant or reconstructive surgery was considered benefit document for coverage reconstructive surgery by Oxford, coverage may exist for removal, determination) replacement and/or reconstruction. If the original implant or reconstructive  Updated supporting information surgery was considered reconstructive surgery under the Oxford benefit to reflect the most current document, then removal of a ruptured prosthesis is treating a "complication background information and arising from a medical or surgical intervention." Removal or replacement of references an implant that is not ruptured and unassociated with local breast complications may not be covered.

Additional Information: An in-network exception may be granted if there is not an in-network provider able to provide the requested reconstructive procedure. Refer to the Member specific benefit document and the In-Network Exceptions for

24 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Breast Jan. 1, 2016 Breast Reconstruction Surgery Following Mastectomy policy for information Reconstruction Post regarding coverage from non-network providers. Mastectomy (continued) Breast reconstruction may be covered under certain circumstances for the surgical treatment of gender dysphoria. Please refer to the member’s specific benefit document for coverage determination.

Treatments for complications post mastectomy

1. Lymphedema: a. Complex Decongestive Physiotherapy (CDP) is covered for the complication of lymphedema post mastectomy b. Lymphedema pumps when required are covered c. Compression Lymphedema sleeves are covered d. Elastic bandages and wraps associated with covered treatments for the complications of lymphedema

2. Treatment of a post-operative infection(s).

3. Removal of a ruptured breast implant (either silicone or saline) is reconstructive for implants done post mastectomy. Placement of a new breast implant will be covered if the original implantation was done post mastectomy or for a covered reconstructive health service.

Coverage Limitations and Exclusions

Please refer to Member’s state mandates and Member specific benefit documents.

1. Insertion of breast implants or reinsertion of breast implants for the purpose of improving appearance is a cosmetic procedure unless covered under a state or federal mandate. Note: If the breast reconstruction has been successfully completed post mastectomy and the Member chooses to enlarge their breasts for cosmetic reasons, this is considered a cosmetic service and is not covered. 2. Breast reconstruction or scar revision after breast biopsy or removal of a cyst with or without a biopsy usually does not meet the definition of a covered reconstructive health service. Refer to the Member’s specific benefit documents and state mandates. 3. Tissue protruding at the end of a scar (“dog ear”/standing cone), painful scars or donor site scar revisions must be reviewed to determine if the

25 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Breast Jan. 1, 2016 procedure meets reconstructive guidelines. Reconstruction Post 4. Liposuction other than to achieve breast symmetry during post Mastectomy mastectomy reconstruction is considered cosmetic and is not covered. (continued) 5. Revision of prior reconstructed breast due to normal aging does not meet the definition of a covered reconstructive health service. 6. Not medically necessary services. Breast Repair/ Jan. 1, 2016  Added reference links to policy If the member's condition meets the Women's Health and Cancer Rights Reconstruction titled Gender Dysphoria (Gender (WHCRA) criteria, please refer to the Breast Reconstruction Post Mastectomy (Not Following a Identity Disorder) Treatment policy. Mastectomy)  Removed reference link to policy titled Gynocomastia Criteria for a Coverage Determination as Reconstructive and  Revised coverage Medically Necessary: rationale/indications for A. Removal of breast implants with capsulectomy/capsulotomy for coverage: symptomatic capsular contracture is considered reconstructive o Updated criterion pertaining to and medically necessary when the following criteria are met: correction of inverted nipples; 1. Baker grade III or IV capsular contracture; added language to indicate Baker Grading System for Capsular Contracture correction of congenital . Grade I - breast is soft without palpable thickening inverted nipples may be . Grade II - breast is a little firm but no visible changes in covered based on state appearance mandate or the enrollee . Grade III - breast is firm and has visible distortion in shape specific benefit document . Grade IV - breast is hard and has severe distortion or malposition in (refer to the definition of shape; pain/discomfort may be associated with this level of capsule “congenital anomaly”) contracture (ASPS, 2005) o Added language to indicate 2. Limited movement leading to an inability to perform tasks that involve breast reconstruction may be reaching or abduction. Examples include retrieving something from covered under certain overhead, combing one's hair, reaching out or above to grab circumstances for the surgical something to stabilize oneself. treatment of gender dysphoria B. Removal of a deflated saline breast implant shell is considered (refer to the enrollee specific cosmetic and is not medically necessary unless the implants were benefit document for coverage done post-mastectomy. Refer to the Breast Reconstruction Post determination) Mastectomy policy. o Added reference link to policy C. Correction of inverted nipples is considered reconstructive and titled Breast Reconstruction medically necessary when one of the following criteria are met: Post Mastectomy 1. Member meets the Women's Health and Cancer Rights Act (WHCRA)  Updated list of applicable CPT criteria (refer to the Breast Reconstruction Post Mastectomy policy for codes; removed 19340, 19342, details); or 19350, 19357, 19361, 19364, 2. Documented history of chronic nipple discharge, bleeding, scabbing or

26 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Breast Repair/ Jan. 1, 2016 19366, 19367, 19368 and 19369 ductal infection: or Reconstruction 3. If the correction of congenital inverted nipples may be covered based (Not Following a on the state mandates or member’s specific document. See Mastectomy) Congenital Anomaly definition. (continued) D. Revision of a reconstructed (CPT Code 19380) breast is considered reconstructive and medically necessary when the original reconstruction was done for mastectomy or other covered health service. See Applicable Codes section of the policy for a list of codes that meet the criteria for a reconstructed breast. E. Breast reconstruction done for Poland Syndrome (see definition) is reconstructive. Although no functional impairment may exist for the breast reconstruction for Poland Syndrome, this has been deemed reconstructive surgery. F. Removal of a ruptured silicone gel breast implant is covered regardless of the indication for the initial implant placement.

Additional Information: Tissue protruding at the end of a scar ("dog ear"/standing cone), painful scars or donor site scar revisions must be reviewed to determine if the procedure meets reconstructive guidelines.

Breast reconstruction may be covered under certain circumstances for the surgical treatment of gender dysphoria. Please refer to the member’s specific benefit document for coverage determination.

Limitations and Exclusions Some states require benefit coverage for services that Oxford considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to Member’s plan specific documents. A. Cosmetic breast procedures are excluded from coverage. 1. Examples include but are not limited to: . Replacement of an existing breast implant if the earlier breast implant was performed as a cosmetic procedure (Replacement of an existing breast implant is considered reconstructive if the initial breast implant followed mastectomy. Refer to the Breast Reconstruction Post Mastectomy policy) . Breast reduction surgery that is determined to be a cosmetic

27 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Breast Repair/ Jan. 1, 2016 procedure. This exclusion does not apply to breast reduction Reconstruction surgery which we determine is requested to treat a physiologic (Not Following a functional impairment or to coverage required by the Women's Mastectomy) Health and Cancer Right's Act. (continued) . Breast surgery only for the purpose of creating symmetrical breasts except when post mastectomy. . Breast prosthetics or replacement following a cosmetic breast augmentation. B. Revision of a prior reconstructed breast due to normal aging does not meet the definition of a covered reconstructive health service. Cardiovascular Jan. 1, 2016  Revised non-coverage rationale; Due to insufficient evidence to support medical efficacy, Disease Risk Tests added language to indicate: cardiovascular disease risk tests will not be reimbursed by Oxford®. o Due to insufficient evidence to Arterial compliance testing, using waveform analysis is unproven support medical efficacy, and not medically necessary as a method to determine risk for cardiovascular disease risk cardiovascular disease. tests will not be reimbursed by There is insufficient evidence to conclude that noninvasive arterial Oxford compliance testing is effective as a screening tool for the early detection of o Tests that measure the cardiovascular disease (CVD). There is inadequate clinical evidence from lipoprotein-associated prospective studies that the use of this technology alters patient phospholipase A2 (Lp-PLA2) management and improves clinical outcomes. Additional research involving enzyme and other human A2 larger, well-designed studies is needed to establish the role of arterial phospholipases such as compliance in the early identification, prevention and management of CVD. secretory phospholipase A2 (sPLA2-IIA) are unproven and Carotid intima-media thickness (CIMT) measurement is unproven not not medically necessary as a medically necessary as an effective screening tool for the method to determine risk of management of cardiovascular disease. cardiovascular disease or There is inadequate clinical evidence from prospective studies that the use of ischemic stroke this technology alters patient management and improves clinical outcomes.  Updated list of applicable CPT Additional research involving larger, well-designed studies is needed to codes to reflect annual code edits establish the role of arterial compliance in the early identification, prevention (effective Jan. 1, 2016): and management of CVD. o Added 0423T and 93050 o Removed 0311T Advanced lipoprotein analysis (e.g., apolipoprotein, lipoprotein (a)  Updated supporting information subfractions or particle size) is unproven and not medically to reflect the most current necessary as a method to determine risk of cardiovascular disease. description of services, clinical Studies report inconsistent results regarding the usefulness of advanced evidence, FDA information, and lipoprotein testing. Research has shown a lack of universal, standardized references testing modalities and patient-selection criteria. Additional large, prospective

28 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Cardiovascular Jan. 1, 2016 studies are needed to establish whether measurement of these emerging Disease Risk Tests markers will be more predictive of CVD than conventional lipid risk factors. (continued) Tests that measure the lipoprotein-associated phospholipase A2 (Lp-

PLA ) enzyme and other human A2 phospholipases such as secretory 2 phospholipase A (sPLA -IIA) are unproven and not medically 2 2 necessary as a method to determine risk of cardiovascular disease or

ischemic stroke.

Additional well-designed clinical trials are necessary to establish the clinical

utility of Lp-PLA and sPLA IIA for cardiovascular risk assessment and to 2 2- determine the role of Lp-PLA2 as a potential adjunct to traditional risk

assessment in the management of stroke in adults.

Tests that measure long-chain omega-3 fatty acids are unproven and not medically necessary as a method to determine risk for cardiovascular disease. There is insufficient evidence to conclude that measuring long-chain omega-3 fatty acids is effective as a screening tool for the early detection of cardiovascular disease (CVD). There is inadequate clinical evidence from prospective studies that the use of this technology alters patient management and improves clinical outcomes. Additional research involving larger, well-designed studies is needed to establish the role of arterial compliance in the early identification, prevention and management of CVD.

Endothelial function assessment using tools such as peripheral arterial tonometry (PAT) or brachial artery pressure ultrasound is unproven and not medically necessary as a prognostic indicator to determine risk of cardiovascular disease. There is insufficient evidence in the peer-reviewed medical literature to support the effectiveness and prognostic clinical utility of endothelial function assessment to establish the risk of cardiovascular disease. The majority of the identified studies reported some measure of statistical association of either PAT or brachial artery ultrasound with cardiovascular disease. However, these associations are insufficient to directly demonstrate their clinical utility to effectively predict cardiovascular morbidity. Well-designed studies that extend beyond measures of simple statistical association are needed to demonstrate the clinical usefulness of such assessment tools to effectively predict cardiovascular events and classify patients according to their individual cardiovascular risk.

29 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Diabetes Jan. 1, 2016  Added reference link to policy JANUVIA Medications titled Drug Coverage Guidelines Januvia will be approved based on the following criteria:  Revised coverage rationale 1) Member has a history of a three month trial** resulting in a therapeutic o Added language to indicate failure, or a contraindication, or an intolerance to all of the following Glyxambi will be approved (document dates Member received each medication): based on history of a three a) Onglyza (saxagliptin) month trial** resulting in b) Tradjenta (linagliptin) therapeutic failure, c) Nesina (alogliptin) contraindication or intolerance to all of the following: JANUMET OR JANUMET XR . One of the following Janumet of Janumet XR will be approved based on the following criteria: - Metformin 1) Member has a history of a three month trial* ** resulting in a therapeutic - Sulfonylurea (e.g. failure, or a contraindication, or an intolerance to all of the following glimepiride) (document dates Member received each medication. (Trial of Kombiglyze - Thiazolidinedione (e.g. XR is required to be after 1/1/2010. Trial of Jentadueto is required to be pioglitazone) after 5/1/2011. Trial of Kazano is required to be after 1/1/2013.*): and a) Kombiglyze XR (saxagliptin-metformin extended-release) . Jardiance (empagliflozin); b) Jentadueto (linagliptin-metformin) and c) Kazano (alogliptin/metformin) . Tradjenta (linagliptin) **Only a 30 day trial will INVOKANA AND JARDIANCE be required for Connecticut Invokana and Jardiance will be approved based one of the following criteria: plan members 1) History of failure, contraindication or intolerance to one of the following: o Changed authorization a) Metformin approval timeframe from “60 b) Sulfonylurea (e.g. glimepiride) months” to “12 months” c) Thiazolidinedione (e.g., pioglitazone)  Updated supporting information or to reflect the most current 2) Both of the following: background information and a) Member is currently on therapy with Invokana or Jardiance and is references requesting continuation of the same therapy; and

b) One of the following:

1. Member has not received a manufacturer supplied sample at no

cost as a means to establish as a current user of Invokana or

Jardiance; or

2. Both of the following:

i. Member has received a manufacturer supplied sample at no cost

as a means to establish as a current user of Invokana or

Jardiance; and

30 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Diabetes Jan. 1, 2016 ii. History of failure, contraindication, or intolerance to one of the Medications following: (continued) a. Metformin b. Sulfonylurea (e.g. glimepiride) c. Thiazolindinedione (e.g., pioglitazone)

FARXIGA Farxiga will be approved based on both of the following criteria: 1) Member has a history of a three month trial** resulting in a therapeutic failure, or a contraindication, or an intolerance to one of the following: a) Metformin b) Sulfonylurea (e.g. glimepiride) c) Thiazolidinedione (e.g. rosiglitazone) and 2) Member has a history of a three month trial** resulting in a therapeutic failure, or a contraindication, or intolerance to both of the following: a) Invokana b) Jardiance

XIGDUO XR Xigduo XR will be approved based on the following criterion: 1) History of a three month trial** resulting in a therapeutic failure, or a contraindication, or intolerance to Invokana.

TRULICITY

Trulicity will be approved based on the following criteria:

1) History of a three month trial** resulting in a therapeutic failure,

contraindication, or intolerance to two of the following (list reason for

therapeutic failure, contraindication, or intolerance):

a) Bydureon

b) Byetta

c) Tanzeum

d) Victoza

GLYXAMBI

Glyxambi will be approved based on the following criteria: 1) History of a three month trial** resulting in therapeutic failure, contraindication or intolerance to all of the following:

31 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Diabetes Jan. 1, 2016 a) One of the following Medications i. Metformin (continued) ii. Sulfonylurea (e.g. glimepiride) iii. Thiazolidinedione (e.g. pioglitazone) and b) Jardiance (empagliflozin); and c) Tradjenta (linagliptin)

Authorization will be issued for 12 months.

** For Connecticut business, only a 30 day trial will be required.

Diabetic Test Strips Jan. 1, 2016  Changed policy title; previously Oxford will cover Tier 3 Test Strips* or Blood Glucose Meters as indicated and Meters titled Diabetic Test Strips below.  Added reference link to policy titled Drug Coverage Guidelines A. Abbott Diabetic Test Strips and Meters will be approved based on  Revised coverage rationale: one of the following: o Reformatted coverage criteria 1. All of the following: by meter/test strip brand type a. Patient is currently using an OmniPod Insulin Pump o Updated preferred product b. Patient is requesting only FreeStyle test strips listings c. Patient is not requesting FreeStyle Insulinx, FreeStyle Lite, o Revised coverage criteria to FreeStyle Precision Neo or indicate approval will be based d. Precision Xtra test strips on one of the following: or . Use of an insulin pump that 2. Submission of medical records documenting a physical or mental is associated with the limitation that makes utilization of one of the following Lifescan specific non-preferred test diabetic meter/test strip products unsafe, inaccurate or otherwise not strips; or feasible (e.g. manual dexterity): . Submission of medical a. OneTouch UltraMini Meter (OneTouch Ultra Test Strips) records documenting a b. OneTouch Ultra 2 Meter (OneTouch Ultra Test Strips) physical or mental c. OneTouch Verio Meter (OneTouch Verio Test Strips) limitation that makes d. OneTouch Verio IQ Meter (OneTouch Verio Test Strips) utilization of the meter e. OneTouch Verio Sync Meter (OneTouch Verio Test Strips) associated with the preferred test strips unsafe, Authorization will be issued for 12 months. inaccurate or otherwise not feasible B. Bayer Diabetic Test Strips and Meters will be approved based on o Added language to indication one of the following: authorization will be issued for 1. All of the following: 12 months a. Patient is currently utilizing a MiniMed Insulin Pump

32 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Diabetic Test Strips Jan. 1, 2016  Updated supporting information b. Patient is requesting only Contour Next Link test strips. and Meters to reflect the most current c. Patient is not requesting Breeze2 or Contour test strips (continued) background information and or references 2. Submission of medical records documenting a physical or mental limitation that makes utilization of one of the following Lifescan diabetic meter/test strip products unsafe, inaccurate or otherwise not feasible (e.g. manual dexterity): a. OneTouch UltraMini Meter (OneTouch Ultra Test Strips) b. OneTouch Ultra 2 Meter (OneTouch Ultra Test Strips) c. OneTouch Verio Meter (OneTouch Verio Test Strips) d. OneTouch Verio IQ Meter (OneTouch Verio Test Strips) e. OneTouch Verio Sync Meter (OneTouch Verio Test Strips)

Authorization will be issued for 12 months.

C. Roche Diabetic Test Strips and Meters will be approved based on one of the following: 1. All of the following: a. Patient is currently utilizing an Accu-Chek Combo Insulin Pump b. Patient is requesting only Accu-Chek Aviva Plus test strips. c. Patient is not requesting Accu-Chek Compact, Accu-Chek Compact Plus, or Accu-Chek d. Smartview test strips or 2. Submission of medical records documenting a physical or mental limitation that makes utilization of one of the following Lifescan diabetic meters/test strips product unsafe, inaccurate or otherwise not feasible (e.g. manual dexterity): a. OneTouch UltraMini Meter (OneTouch Ultra Test Strips) b. OneTouch Ultra 2 Meter (OneTouch Ultra Test Strips) c. OneTouch Verio Meter (OneTouch Verio Test Strips) d. OneTouch Verio IQ Meter (OneTouch Verio Test Strips) e. OneTouch Verio Sync Meter (OneTouch Verio Test Strips)

Authorization will be issued for 12 months.

* Quantity Limits may apply

33 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Drug Coverage Jan. 1, 2016  Revised list of medications Refer to the policy for complete details on Drug Coverage Criteria - New and Criteria - New and requiring precertification through Therapeutic Equivalent Medications. Therapeutic the pharmacy benefit manager Equivalent (PBM): Medications o Added Ambien, (brand only), Ambien CR (brand and generic), capecitabine (generic Xeloda), Karbinal ER, Subsys, Tironsint and Varubi o Removed Arnuity Ellipta, Evotaz, Jadenu, Mitigare, Natpara, Oxycodone ER 12 HR Tablet, Scolantra and Xigduo XR o Updated formulary alternative for Abstral, Colchicine capsule (manufacturer of West-Ward), Colchicine tablet (manufacturer of Prasco), Fentora and Glatopa

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Abstral (Fentanyl) Revised  Revised prior authorization/notification guidelines (see Prior Guidelines Authorization/Notification Guidelines: Actiq (fentanyl citrate)): o Updated background information o Modified coverage criteria: . Added criterion requiring a documented cancer diagnosis . Added “fentanyl citrate lozenges (generic Actiq)” to list of opioid analgesics indicated for the management of breakthrough cancer pain Actiq (Fentanyl Citrate) Revised  Revised prior authorization/notification guidelines (see Prior Authorization/Notification Guidelines: Actiq (fentanyl citrate)): o Updated background information o Modified coverage criteria: . Added criterion requiring a documented cancer diagnosis . Added “fentanyl citrate lozenges (generic Actiq)” to list of opioid an- algesics indicated for the management of breakthrough cancer pain

34 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Ambien (Zolpidem Revised  Revised coverage criteria/precertification requirements: Guidelines Tartrate) o Added language to indicate precertification is required through the (continued) Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with two of the following medications: zolpidem, zalepelon or eszopiclone (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications) Ambien CR (Zolpidem Revised  Revised coverage criteria/precertification requirements: Tartrate Extended- o Added language to indicate precertification is required through the Release[ER]) Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with two of the following medications: zolpidem, zalepelon or eszopiclone (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications) Androderm Revised  Revised prior authorization/medical necessity guidelines (see Prior (Testosterone) Authorization/Medical Necessity Guidelines: Androderm): o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy Androgel (Testosterone) Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Androgel): o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy Arnuity Ellipta Revised  Revised coverage criteria/precertification requirements to indicate (Fluticasone Furoate) precertification is no longer required:

35 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Arnuity Ellipta Revised o Removed language indicating precertification is required through the Guidelines (Fluticasone Furoate) Pharmacy Benefit Manager (PBM) (continued) (continued) o Removed therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with a formulary alternative (Asmanex TwistHaler, Alvesco, QVAR or Flovent) and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Auryxia (Ferric Citrate) Revised  Revised coverage criteria/precertification requirements to indicate precertification is no longer required: o Removed language indicating precertification is required through the Pharmacy Benefit Manager (PBM) o Removed prior authorization/medical necessity guidelines and corresponding reference link to policy titled Prior Authorization/Medical Necessity Guidelines: Auryxia Avinza (Morphine Revised  Revised prior authorization/medical necessity guidelines (see Prior Sulface Extended Authorization/Medical Necessity Guidelines: Avinza): Release) (Brand Only) o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Axiron (Testosterone) Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Axiron): o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy Bupropion (Generic Revised  Revised prior authorization/medical necessity guidelines (see Prior Zyban) Authorization/Medical Necessity Guidelines: Tobacco Cessation for Health Care Reform):

36 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Bupropion (Generic Revised o Modified initial authorization criteria to allow for coverage if patient is Guidelines Zyban) currently using bupropion for an indication other than tobacco cessation (continued) o Added notation to indicate pharmacist review is required for more than 2 cycles per 12 month period (one cycle is defined as more than 1 month of medication; if only one month of medication is filled, 2 additional cycles of medication may be authorized in the 12 month period) Butrans (Buprenorphine) Revised  Revised step therapy criteria (see Step Therapy Guidelines: Butrans (buprenorphine): o Updated list of long acting formulary product alternatives to which history of failure, contraindication, or intolerance must be demonstrated: . Added tramadol extended-release (Ultram ER) . Removed Ultram ER (tramadol HCl extended-release) Capecitabine (Generic New  Added coverage criteria/precertification requirements: Xeloda) o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment Xeloda (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications) Cetirizine Solution New  Added coverage guidelines to indicate: (Generic Zyrtec) o Precertification is not required o Prescription drugs for which there is a therapeutic over-the-counter (OTC) equivalent are excluded from coverage; refer to the Member's benefit document as applicable Chantix (Varenicline Revised  Revised prior authorization/medical necessity guidelines (see Prior Tartrate) Authorization/Medical Necessity Guidelines: Tobacco Cessation for Health Care Reform): o Modified initial authorization criteria to allow for coverage if patient is currently using bupropion for an indication other than tobacco cessation o Added notation to indicate pharmacist review is required for more than 2 cycles per 12 month period (one cycle is defined as more than 1 month of medication; if only one month of medication is filled, 2 additional cycles of medication may be authorized in the 12 month period) Colcrys (Colchicine) New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the

37 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Colcrys (Colchicine) New Pharmacy Benefit Manager (PBM) Guidelines (continued) o Added therapeutic equivalent guidelines requiring history of intolerance (continued) or therapeutic failure to treatment with Mitigare (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications) Cordran 0.05 % Cream Revised  Revised step therapy guidelines (see Step Therapy Guidelines: Cordran); (Clurandrenolide) revised coverage criteria: o Modified list of applicable Step 1 medications, added “fluticasone propionate cream 0.05% (generic Cutivate cream)” o Modified list of applicable Step 2 medications: . Removed “fluticasone propionate cream 0.05% (generic Cutivate cream)” . Replaced “fluticasone propionate 0.05% lotion (generic Cultivate lotion)” with “Cultivate lotion (fluticasone propionate 0.05% lotion)” Cordran 0.05% Lotion Revised  Revised step therapy guidelines (see Step Therapy Guidelines: Cordran); (Flurandrenolide) revised coverage criteria: o Modified list of applicable Step 1 medications, added “fluticasone propionate cream 0.05% (generic Cutivate cream)” o Modified list of applicable Step 2 medications: . Removed “fluticasone propionate cream 0.05% (generic Cutivate cream)” . Replaced “fluticasone propionate 0.05% lotion (generic Cultivate lotion)” with “Cultivate lotion (fluticasone propionate 0.05% lotion)” Cultivate (Fluticasone New  Added coverage criteria/precertification requirements: Propionate 0.05%) o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added step therapy guidelines to indicate authorization will be issued/approved for 60 months based on the following criteria (see Step Therapy Guidelines: Cultivate): . History of failure, contraindication or intolerance to one step 1 medication in the same potency class (Lower-mid, group V): - hydrocortisone butyrate 0.1% ointment (generic Locoid ointment) - hydrocortisone valerate 0.2% cream (generic Westcort cream) - prednicarbate 0.1% cream (generic Dermatop cream) - prednicarbate 0.1% ointment (generic Dermatop ointment) - triamcinolone acetonide 0.1% lotion (generic Kenalog lotion) - triamcinolone acetonide 0.025% ointment (generic Kenalog ointment) - fluticasone propionate cream 0.05% (generic Cutivate cream)

38 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Daklinza (Daclatasvir) Revised  Revised prior authorization/medical necessity guidelines; modified Guidelines coverage criteria: (continued) o Updated coverage criteria based on review of recently published information/data o Removed criterion requiring treatment-failure with a previous regimen that included Sovaldi (sofosbuvir) plus ribavirin for patients with cirrhosis Daliresp (Roflumilast) Updated  Updated background information and references; no change to coverage guidelines (see Prior Authorization/Notification Guidelines: Daliresp) Differin 0.3% Gel New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added prior authorization/notification guidelines to indicate authorization will be issued/approved for 12 months based on both of the following criteria (see Prior Authorization/Notification Guidelines: Differin): . The member has a non-cosmetic medical condition (e.g., acne vulgaris, psoriasis, precancerous skin lesions); and . Medication is not being requested for cosmetic purposes (e.g., photoaging, wrinkling, hyperpigmentation, sun damage, melasma)  Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with adapalene gel (generic Differin gel) or Differin 0.1% gel (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications) Embeda Revised  Revised prior authorization/medical necessity guidelines (see Prior (Morphine/Naltrexone) Authorization/Medical Necessity Guidelines: Embeda): o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Esomeprazole Strontium Revised  Revised coverage criteria/precertification requirements to indicate precertification is no longer required: o Removed language indicating precertification is required through the

39 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Esomeprazole Strontium Revised Pharmacy Benefit Manager (PBM) Guidelines (continued) o Added language to indicate prescription drugs for which there is a (continued) therapeutic over-the-counter (OTC) equivalent are excluded from coverage; refer to the Member's benefit document as applicable o Removed reference link to policy titled Precertification Guidelines: Proton Pump Inhibitors Evotaz Revised  Revised coverage criteria/precertification requirements to indicate (Atazanavir/Cobicistat) precertification is no longer required: o Removed language indicating precertification is required through the Pharmacy Benefit Manager (PBM) o Removed therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with a formulary alternative (Reyataz or Tybost) and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Exalgo (Hydromorphone) Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Exalgo): o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Exjade (Deferasirox) Revised  Revised prior authorization/notification guidelines (see Prior Authorization/Notification Guidelines: Exjade): o Updated background information o Revised initial authorization criteria for treatment of chronic iron overload due to blood transfusions (i.e., transfusional iron overload); removed criterion requiring: . Patient has blood transfusion of at least 100 mL/kg of packed red blood cells (e.g., at least 20 units of packed red blood cells for a 40- kg person or more in individuals weighing more than 40 kg) prior to initiation of treatment with Exjade . Patient has serum ferritin levels consistently >1000 mcg/L prior to initiation of treatment with Exjade

40 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Ferriprox (Deferiprone) Revised  Revised prior authorization/notification guidelines (see Prior Guidelines Authorization/Notification Guidelines: Ferriprox): (continued) o Updated background information o Revised initial authorization criteria for treatment of chronic iron overload due to blood transfusions (i.e., transfusional iron overload); removed criterion requiring: . Patient has blood transfusion of at least 100 mL/kg of packed red blood cells (e.g., at least 20 units of packed red blood cells for a 40- kg person or more in individuals weighing more than 40 kg) prior to initiation of treatment with Ferriprox . Patient has serum ferritin levels consistently >1000 mcg/L prior to initiation of treatment with Ferriprox Fentora (Fentanyl Revised  Revised prior authorization/notification guidelines (see Prior Buccal) Authorization/Notification Guidelines: Fentora (fentanyl buccal)); updated coverage criteria: o Updated background information o Added criterion requiring a documented cancer diagnosis o Added fentanyl citrate lozenges (generic Actiq) to list of opioid analgesics indicated for the management of breakthrough cancer pain Forteo (Teriparatide) Updated  Updated background information and references; no change to coverage guidelines (see Prior Authorization/Notification Guidelines: Teriparatide (Forteo) Fortesta (Testosterone): Revised  Revised prior authorization/medical necessity guidelines (see Prior Gel Authorization/Medical Necessity Guidelines: Fortesta): o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy Glatopa (Glatiramer Revised  Updated medication/drug name; previously listed as Glatiramer 20mg 20mg [Generic (generic copaxone) Copaxone])  Added prior authorization/notification guidelines to indicate authorization will be issued/approved for 60 months based on the following criteria* (see Prior Authorization/Notification Guidelines: Glatopa): o Diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., relapsing-

41 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Glatopa (Glatiramer Revised remitting MS, secondary-progressive MS with relapses, progressive- Guidelines 20mg [Generic relapsing MS with relapses) (continued) Copaxone]) *Note: Glatopa is excluded from coverage for the majority of our (continued) benefits Glyxambi (Empagliflozin/ Revised  Added step therapy guidelines for New Jersey plan members to indicate Linagliptin) authorization will be issued/approved for 12 months based on the following criteria* (see Step Therapy Guidelines: Diabetes Medications (NJ)): o History of a three month trial resulting in therapeutic failure, contraindication or intolerance to all of the following: . One of the following - Metformin - Sulfonylurea (e.g., glimepiride) - Thiazolidinedione (e.g., pioglitazone) and . Jardiance (empagliflozin); and . Tradjenta (linagliptin) *Note: Glyxambi is typically excluded from coverage (tried/failed criteria may be in place); refer to the plan specifics to determine coverage status  Added precertification guidelines for Connecticut and New York plan members to indicate authorization will be issued/approved for 12 months based on the following criteria (see Precertification Guidelines: Diabetes Medications (CT/NY)): o History of a three month trial** resulting in therapeutic failure, contraindication or intolerance to all of the following: . One of the following - Metformin - Sulfonylurea (e.g. glimepiride) - Thiazolidinedione (e.g. pioglitazone) and . Jardiance (empagliflozin); and . Tradjenta (linagliptin) **For Connecticut plan members, only a 30 day trial will be required Harvoni ™ Revised  Revised prior authorization/medical necessity guidelines; modified (Ledipasvir/Sofosbuvir) coverage criteria: o Updated coverage criteria based on review of recently published information/data o Added coverage criteria for treatment of chronic hepatitis C (CHC)

42 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Harvoni ™ Revised genotype 5 or 6 infection in adults Guidelines (Ledipasvir/Sofosbuvir) (continued) (continued) Hysingla ER Revised  Revised prior authorization/medical necessity guidelines (see Prior (Hydrocodone Bitartrate) Authorization/Medical Necessity Guidelines: Hysingla ER): o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Iressa (Gefitinib) New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added prior authorization/notification guidelines to indicate authorization will be issued/approved for 12 months based on the following criteria (see Prior Authorization/Notification Guidelines: Iressa): . Authorization for patients less than 19 years of age will be issued/approved for 12 months based on the following criterion: - Member is less than 19 years of age . Initial authorization for treatment of Non-Small Cell Lung Cancer (NSCLC) will be issued/approved for 12 months based on both of the following criteria: - Diagnosis of metastatic non-small cell lung cancer (NSCLC); and - One of the following:  Tumors are positive for epidermal growth factor receptor (EGFR) exon 19 deletions  Tumors are positive for exon 21 (L858R) substitution mutations . Reauthorization for treatment of Non-Small Cell Lung Cancer (NSCLC) will be issued/approved for 12 months based on the following criteria: - Patient does not show evidence of progressive disease while on Iressa therapy

43 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Jadenu (Defirasirox) Revised  Added prior authorization/notification guidelines (see Prior Guidelines Authorization/Notification Guidelines: Jadenu): (continued) o Updated background information o Added coverage criteria for treatment of chronic iron overload due to blood transfusions (i.e., transfusional iron overload) to indicate: . Initial authorization will be issued/approved for 12 months based on diagnosis of chronic iron overload (e.g., sickle cell anemia, thalassemia, etc.) due to blood transfusion . Reauthorization will be issued/approved for 12 months based on documentation of positive clinical response to Jadenu therapy o Added coverage criteria for treatment of chronic iron overload in non- transfusion dependent thalassemia syndromes to indicate: . Initial authorization will be issued/approved for 12 months based on all of the following criteria: - Diagnosis of chronic iron overload in non-transfusion dependent thalassemia syndrome; and - Patient has liver iron (Fe) concentration (LIC) levels consistently ≥ 5 mg Fe per gram of dry weight prior to initiation of treatment with Jadenu; and - Patient has serum ferritin levels consistently > 300 mcg/L prior to initiation of treatment with Jadenu . Reauthorization will be issued/approved for 12 months based on documentation of positive clinical response to Jadenu therapy  Removed therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with a formulary alternative (Exjade) and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Juxtapid (Lomitapide) Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Juxtapid) to indicate: o Initial authorization will be issued/approved for 6 months based on all of the following criteria: . Diagnosis of homozygous familial hypercholesterolemia (HoFH) as confirmed by submission of medical records (e.g., chart notes, laboratory values) documenting both of the following:* - One of the following:  Pre-treatment LDL-C greater than 500 mg/dL  Treated LDL-C greater than 300 mg/dL and - One of the following:

44 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Juxtapid (Lomitapide) Revised  Xanthoma before 10 years of age Guidelines (continued)  Evidence of heterozygous familial hypercholesterolemia (HeFH) (continued) in both parents and . Used as an adjunct to a low-fat diet and exercise; and . Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe, LDL apheresis); and . Prescribed by one of the following: - Cardiologist - Endocrinologist - Lipid specialist and . History of intolerance, failure or contraindication to Repatha (evolocumab); and . Not used in combination with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor; and . Not used in combination with Kynamro (mipomersen) *Results of prior genetic testing can be submitted as confirmation of diagnosis of HoFH, however please note that UnitedHealthcare commercial plans do not currently cover genetic testing for evidence of an LDL-receptor mutation, familial defective apo B-100 or a PCSK9 mutation o Reauthorization will issued/approved for 12 months based on all of the following criteria: . Patient is continuing a low-fat diet and exercise regimen; and . Patient continues to receive other lipid-lowering therapy (e.g., statin, LDL apheresis); and . Submission of medical records (e.g., chart notes, laboratory values) documenting LDL-C reduction while on Juxtapid therapy; and . Prescribed by one of the following: - Cardiologist - Endocrinologist - Lipid specialist and . Not used in combination with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor; and . Not used in combination with Kynamro (mipomersen) Kadian (Morphine Sulfate Revised  Revised prior authorization/medical necessity guidelines (see Prior Extended Release) Authorization/Medical Necessity Guidelines: Hysingla ER):

45 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Kadian (Morphine Sulfate Revised o Updated background information; added language detailing FDA Guidelines Extended Release) approved age ranges for long-acting opioids (continued) (continued) o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Karbinal ER New  Added coverage criteria/precertification requirements: (Carbinoxamine Maleate) o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with carbinoxamine tablets (generic Palgic) (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications) Kuvan (Sapropterin Revised  Revised prior authorization/notification guidelines (see Prior Dihydrochloride) Authorization/Notification Guidelines: Kuvan): o Updated background information o Changed initial authorization approval timeframe from “2 months” to “6 months” o Revised reauthorization criteria: . Removed criterion requiring: - Diagnosis of phenylketonuria (PKU) - Patient has shown a decrease in blood Phe levels at the end of 1 month of therapy at maximum dosing . Added criterion requiring: - Blood Phe levels continue to remain lower than baseline level Kynamro (Mipomersen Revised  Revised prior authorization/medical necessity guidelines (see Prior Sodium) Authorization/Medical Necessity Guidelines: Kynamro); added coverage criteria to indicate: o Initial authorization will be issued/approved for 6 months based on all of the following criteria: . Diagnosis of homozygous familial hypercholesterolemia (HoFH) as confirmed by submission of medical records (e.g., chart notes, laboratory values) documenting both of the following:* - One of the following:  Pre-treatment LDL-C greater than 500 mg/dL  Treated LDL-C greater than 300 mg/dL

46 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Kynamro (Mipomersen Revised and Guidelines Sodium) - One of the following: (continued) (continued)  Xanthoma before 10 years of age  Evidence of heterozygous familial hypercholesterolemia (HeFH) in both parents and . Used as an adjunct to a low-fat diet and exercise; and . Patient is receiving other lipid-lowering therapy (e.g., statin, ezetimibe, LDL apheresis); and . Prescribed by one of the following: - Cardiologist - Endocrinologist - Lipid specialist and . History of intolerance, failure or contraindication to Repatha (evolocumab); and . Not used in combination with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor; and . Not used in combination with Juxtapid (lomitapide) *Results of prior genetic testing can be submitted as confirmation of diagnosis of HoFH, however please note that UnitedHealthcare commercial plans do not currently cover genetic testing for evidence of an LDL-receptor mutation, familial defective apo B-100 or a PCSK9 mutation o Reauthorization will be issued/approved for 12 months based on all of the following criteria: . Patient is continuing a low-fat diet and exercise regimen; and . Patient continues to receive other lipid-lowering therapy (e.g., statin, LDL apheresis); and . Submission of medical records (e.g., chart notes, laboratory values) documenting LDL-C reduction while on Kynamro therapy; and . Prescribed by one of the following: - Cardiologist - Endocrinologist - Lipid specialist and . Not used in combination with a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor; and

47 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Kynamro (Mipomersen Revised . Not used in combination with Juxtapid (lomitapide) Guidelines Sodium) (continued) (continued) Lamictal ODT Revised  Revised prior authorization/medical necessity guidelines to indicate (see (Lamotrigine Orally Prior Authorization/Medical Necessity Guidelines: Lamictal ODT): Disintegrating Tablets) o Authorization for treatment of epilepsy, seizures and status epilepticus will be issued/approved for 5 years based on one of the following criteria: . All of the following: - History of greater than or equal to 4 week trial of the therapeutically equivalent generic; and - Documented history of an inadequate response to the therapeutically equivalent generic as evidenced by one of the following:  Change in seizure frequency from baseline  Breakthrough seizures not explained by medication noncompliance or significant provoking factor  Status epilepticus and - One of the following:  The FDA has been notified of the lack of effectiveness of the therapeutically equivalent generic through the FDA Adverse Event Reporting System (FAERS); or  Submission of medical records documenting the inadequate response to the therapeutically equivalent generic or . Both of the following: - Documented history of intolerance to the therapeutically equivalent generic which is unable to be resolved with attempts to minimize the adverse effects where appropriate (e.g. change timing of dosing, divide daily dose out for more frequent but smaller doses); and - One of the following:  The FDA has been notified of the adverse effect of the therapeutically equivalent generic through the FDA Adverse Event Reporting System (FAERS); or  Submission of medical records documenting the adverse effect of the therapeutically equivalent generic or

48 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Lamictal ODT Revised . Documented history of drug-resistant epilepsy (defined as the failure Guidelines (Lamotrigine Orally of two tolerated and appropriately chosen and used anti-epileptic (continued) Disintegrating Tablets) drug schedules [as either mono-therapy or combination therapy] to (continued) achieve sustained seizure freedom); or . Documented history of a high risk for seizure recurrence defined as one or more of the following: - Identifiable brain disease - Mental retardation - Abnormal neurologic examination - Seizure onset after the first decade - Multiple seizure types - Poor initial response to treatment - Juvenile myoclonic epilepsy - Epileptiform discharges on electroencephalogram (EEG) - Family history of epilepsy - Hippocampal atrophy or abnormal hippocampal signal on magnetic resonance imaging (MRI) o Authorization for treatment of other indications (e.g., mania, bipolar disorder, migraine prophylaxis, neuropathy, postherpetic neuralgia) will be issued/approved for 5 years based on one of the following criteria: . All of the following: - History of greater than or equal to 4 week trial of the therapeutically equivalent generic; and - Documented history of an inadequate response to the therapeutically equivalent generic; and - One of the following:  The FDA has been notified of the lack of effectiveness of the therapeutically equivalent generic through the FDA Adverse Event Reporting System (FAERS); or  Submission of medical records documenting the inadequate response to the therapeutically equivalent generic or . Both of the following: - Documented history of intolerance to the therapeutically equivalent generic which is unable to be resolved with attempts to minimize the adverse effects where appropriate (e.g. change timing of dosing, divide daily dose out for more frequent but smaller doses); and - One of the following:

49 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Lamictal ODT Revised  The FDA has been notified of the adverse effect of the Guidelines (Lamotrigine Orally therapeutically equivalent generic through the FDA Adverse (continued) Disintegrating Tablets) Event Reporting System (FAERS); or (continued)  Submission of medical records documenting the adverse effect of the therapeutically equivalent generic Lazanda (Fentanyl Nasal Revised  Revised prior authorization/notification guidelines (see Prior Spray) Authorization/Notification Guidelines: Lazanda): o Updated background information o Updated coverage criteria: . Added criterion requiring a documented cancer diagnosis . Added fentanyl citrate lozenges (generic Actiq) to list of opioid analgesics indicated for the management of breakthrough cancer pain Lescol XL (Fluvastatin) New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added step therapy guidelines to indicate authorization will be issued/approved for 60 months based on history of failure, contraindication or intolerance to three of the following (see: Step Therapy Guidelines: Lesxol): . atorvastatin (generic Lipitor) . fluvastatin (generic Lescol) . lovastatin (generic Mevacor) . pravastatin (generic Pravachol) . simvastatin (generic Zocor) Livalo (Pitavastatin) New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added step therapy guidelines to indicate authorization will be issued/approved for 60 months based on history of failure, contraindication or intolerance to three of the following (see Step Therapy Guidelines: Livalo): . atorvastatin (generic Lipitor) . fluvastatin (generic Lescol) . lovastatin (generic Mevacor) . pravastatin (generic Pravachol) . simvastatin (generic Zocor) Mitigare (Colchicine) Revised  Revised coverage criteria/precertification requirements to indicate

50 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Mitigare (Colchicine) Revised precertification is no longer required: Guidelines (continued) o Removed language indicating precertification is required through the (continued) Pharmacy Benefit Manager (PBM) o Removed therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with a formulary alternative (Colcrys) and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications MS Contin Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: MS Contin): o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Multaq (Dronedarone) New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added prior authorization/notification guidelines to indicate initial authorization will be issued/approved for 12 months based on all of the following criteria (see Prior Authorization/Notification Guidelines: Multaq): . Diagnosis of one of the following: - Paroxysmal atrial fibrillation (AF) - Persistent AF defined as AF less than 6 months duration and . One of the following: - Patient is in sinus rhythm - Patient is planned to undergo cardioversion to sinus rhythm and . Patient has none of the following: - NYHA Class IV heart failure - Symptomatic heart failure with recent decompensation requiring hospitalization Natesto (Testosterone Revised  Revised prior authorization/medical necessity guidelines (see Prior Nasal Gel) Revised Authorization/Medical Necessity Guidelines: Natesto):

51 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Natesto (Testosterone o Updated initial authorization criteria; added language to clarify Guidelines Nasal Gel) authorization will be issued for: (continued) (continued) . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy Natpara (Parathyroid Revised  Added prior authorization/medical necessity guidelines to indicate (see Hormone) Prior Authorization/Medical Necessity Guidelines: Natpara): o Initial authorization will be issued/approved for 6 months based on all of the following criteria: . Submission of medical records (e.g., chart notes, laboratory values) documenting all the following: - Diagnosis of hypocalcemia resulting from chronic hypoparathyroidism - 25-hydroxy vitamin D level is above the lower limit of the normal laboratory reference range - Patient is currently on active vitamin D (calcitriol) therapy - Total serum calcium level (albumin corrected) is above 7.5 mg/dL and . One of the following: - Patient is currently on calcium supplementation of 1-2 grams per day of elemental calcium in divided doses; or - Patient has a labeled contraindication to calcium supplementation documented in his/her medical records and . Prescribed by one of the following: - Endocrinologist - Nephrologist o Reauthorization will be issued/approved for 12 months based on all of the following criteria: . Submission of medical records (e.g., chart notes, laboratory values) documenting total serum calcium level (albumin corrected) within the lower half of the normal range (approximately 8 to 9 mg/dL); and . Patient continues to take concomitant active vitamin D (calcitriol) therapy and calcium supplementation unless documented contraindication; and

52 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Natpara (Parathyroid Revised . Prescribed by one of the following: Guidelines Hormone) - Endocrinologist (continued) (continued) - Nephrologist  Removed therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with a formulary alternative [Calcitriol (generic Rocaltrol)] and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Nicotine OTC Products: Revised  Revised prior authorization/medical necessity guidelines (see Prior Habitrol OTC Authorization/Medical Necessity Guidelines: Tobacco Cessation for Health Nicoderm CQ OTC Care Reform): Nicorette Gum OTC o Added notation to indicate pharmacist review is required for more than Nicorette Lozenge OTC 2 cycles per 12 month period (one cycle is defined as more than 1 Nicorette Mini-Lozenge month of medication; if only one month of medication is filled, 2 OTC additional cycles of medication may be authorized in the 12 month Thrive Gum OTC period) Thrive Lozenge OTC Nicotrol Inhaler Revised  Revised prior authorization/medical necessity guidelines (see Prior (Nicotine) Authorization/Medical Necessity Guidelines: Tobacco Cessation for Health Care Reform): o Added notation to indicate pharmacist review is required for more than 2 cycles per 12 month period (one cycle is defined as more than 1 month of medication; if only one month of medication is filled, 2 additional cycles of medication may be authorized in the 12 month period) Nicotrol NS (Nicotine) Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Tobacco Cessation for Health Care Reform): o Added notation to indicate pharmacist review is required for more than 2 cycles per 12 month period (one cycle is defined as more than 1 month of medication; if only one month of medication is filled, 2 additional cycles of medication may be authorized in the 12 month period) Nuvigil (Armodafinil) Updated  Updated background information and references; no change to coverage guidelines (see Prior Authorization/Notification Guidelines: Nuvigil) Odomzo (Sonidegib) New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added prior authorization/notification guidelines to indicate (see Prior

53 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Odomzo (Sonidegib) New Authorization/Notification Guidelines: Odomzo): Guidelines (continued) . Authorization for patients less than 19 years of age will be (continued) issued/approved for 12 months based on the following criterion: - Member is less than 19 years of age . Initial authorization for treatment of basal cell carcinoma will be issued/approved for 12 months based on both of the following criteria: - Diagnosis of locally advanced basal cell carcinoma (BCC); and - One of the following:  Cancer has recurred following surgery  Cancer has recurred following radiation  Patient is not a candidate for surgery  Patient is not a candidate for radiation . Reauthorization for treatment of basal cell carcinoma will be issued/approved for 12 months based on the following criteria: - Patient does not show evidence of progressive disease while on Odomzo therapy Olysio (Simeprevir) Revised  Revised prior authorization/medical necessity guidelines; modified coverage criteria: o Updated coverage criteria based on review of recently published information/data Oxycontin (Oxycodone Revised  Revised prior authorization/medical necessity guidelines (see Prior Extended Release) Authorization/Medical Necessity Guidelines: Oxycontin): o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Oxycodone ER 12hr Revised  Revised prior authorization/medical necessity guidelines (see Prior Tablet Authorization/Medical Necessity Guidelines: Oxycodone ER): o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed

54 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Oxycodone ER 12hr Revised medication Guidelines Tablet . Added language to clarify which brand and generic versions of listed (continued) (continued) products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred)  Removed therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with a formulary alternative (Oxycontin) and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Oxymorphone Extended Revised  Revised prior authorization/medical necessity guidelines (see Prior Release Authorization/Medical Necessity Guidelines: Oxymorphone): o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Procysbi (Cysteamine Revised  Revised step therapy guidelines (see Step Therapy Guidelines: Procysbi) Bitartrate) o Updated background information to indicate Procysbi is indicated for the management of nephropathic cystinosis in adults and children ages 2 years and older o Replaced coverage criterion requiring “patient has not received a manufacturer supplied sample at no cost as a means to establish as a current user of Procysbi” with “patient has not received a manufacturer supplied sample at no cost from a prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Procysbi” Provigil (Modafinil) Updated  Updated background information and references; no change to coverage (Brand and Generic) guidelines (see Prior Authorization/Notification Guidelines: Provigil) Qudexy XR (Topiramate) Revised  Revised prior authorization/medical necessity guidelines to indicate (see Prior Authorization/Medical Necessity Guidelines: Qudexy XR): o Authorization for treatment of epilepsy, seizures and status epilepticus will be issued/approved for 5 years based on one of the following criteria: . Both of the following: - History of greater than or equal to 4 week trial of either topiramate or Topamax; and

55 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Qudexy XR (Topiramate) Revised - One of the following: Guidelines (continued)  Documented history of an inadequate response to the (continued) corresponding release product as evidenced by one of the following: o Change in seizure frequency from baseline o Breakthrough seizures not explained by medication noncompliance or significant provoking factor o Status epilepticus or  Documented history of intolerance to the corresponding release product which is unable to be resolved with attempts to minimize the adverse effects where appropriate (e.g., change timing of dosing, divide daily dose out for more frequent but smaller doses) or . Documented history of drug-resistant epilepsy (defined as the failure of two tolerated and appropriately chosen and used anti-epileptic drug schedules [as either mono-therapy or combination therapy] to achieve sustained seizure freedom); or . Documented history of a high risk for seizure recurrence defined as one or more of the following: - Identifiable brain disease - Mental retardation - Abnormal neurologic examination - Seizure onset after the first decade - Multiple seizure types - Poor initial response to treatment - Juvenile myoclonic epilepsy - Epileptiform discharges on electroencephalogram (EEG) - Family history of epilepsy - Hippocampal atrophy or abnormal hippocampal signal on magnetic resonance imaging (MRI) o Authorization for treatment of other indications (e.g., mania, bipolar disorder, migraine prophylaxis, neuropathy, postherpetic neuralgia) will be issued/approved for 5 years based on one of the following criteria: . Both of the following: - History of greater than or equal to 4 week trial of either topiramate or Topamax; and - Documented history of an inadequate response to the

56 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Qudexy XR (Topiramate) Revised corresponding release product Guidelines (continued) or (continued) . Documented history of intolerance to the corresponding release product which is unable to be resolved with attempts to minimize the adverse effects where appropriate (e.g., change timing of dosing, divide daily dose out for more frequent but smaller doses) Repatha (Evolocumab) Revised  Revised prior authorization/notification guidelines (see Prior Authorization/Notification Guidelines: Repatha): o Revised initial authorization criteria for treatment of primary hyperlipidemia; added criterion requiring one of the following: . One of the following as documented by prescription claims history or medical record: - History of failure after 12 consecutive weeks of Praluent - History of intolerance to Praluent therapy or . Both of the following: - Patient is currently on Repatha therapy; and - One of the following:  Patient has not received a manufacturer supplied sample at no cost in prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Repatha; or  Both of the following: o Patient has received a manufacturer supplied sample at no cost in prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Repatha; and o Patient has a history of failure or intolerance to Praluent therapy  Removed therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with a formulary alternative [atorvastatin (generic Lipitor), simvastatin (generic Zocor), pravastatin (generic Pravachol), or Crestor] and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Solaraze (Diclofenac) New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added prior authorization/notification guidelines to indicate

57 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Solaraze (Diclofenac) New authorization will be issued/approved for 3 months based on the Guidelines (continued) following criterion (see Prior Authorization/Notification Guidelines: (continued) Solaraze): . Diagnosis of actinic keratosis Soolantra (Ivermectin) Revised  Added step therapy guidelines to indicate authorization will be issued/approved for 60 months based on the following criteria (see Step Therapy Guidelines: Soolantra): o History of failure, contraindication or intolerance to both of the following medications: . An oral antibiotic (i.e. doxycycline*, minocycline, tetracycline) . Metronidazole 0.75% gel (generic Metrogel) *Adoxa tablets (multi-source brand only), Adoxa Pak, Doryx, Monodox 50 mg and100 mg (multi-source brand only), Monodox 75 mg, Morgidox Kit are typically excluded from coverage (tried/failed criteria may be in place);refer to plan specifics to determine exclusion status Sovaldi (Sofosbuvir) Revised  Revised prior authorization/medical necessity guidelines; modified coverage criteria: o Updated coverage criteria based on review of recently published information/data o For Sovaldi plus Daklinza regimens: Removed criterion requiring treatment-failure with a previous regimen that included Sovaldi (sofosbuvir) plus ribavirin for patients with cirrhosis Striant (Testosterone) Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Striant): o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy Subsys (Fentanyl Revised  Revised prior authorization/notification guidelines (see Prior Sublingual Spray) Authorization/Notification Guidelines: Subsys): o Updated background information o Updated coverage criteria: . Added criterion requiring a documented cancer diagnosis . Added fentanyl citrate lozenges (generic Actiq) to list of opioid

58 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Subsys (Fentanyl Revised analgesics indicated for the management of breakthrough cancer Guidelines Sublingual Spray) pain (continued) (continued) . Added notation to indicate Subsys is typically excluded from coverage (tried/failed criteria may be in place); refer to the plan specifics to determine coverage status  Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with fentanyl citrate lozenges (generic Actiq) or Lazanda (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications) Targretin Gel New  Added coverage criteria/precertification requirements: (Bexarotene) o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added prior authorization/notification guidelines to indicate (see Prior Authorization/Notification Guidelines: Targretin Gel): . Authorization for patients less than 19 years of age will be issued/approved for 12 months based on the following criterion: - Member is less than 19 years of age . Initial authorization for treatment of Non-Hodgkin’s Lymphoma (NHL) will be issued/approved for 12 months based on one of the following diagnoses: - T-Cell Leukemia/Lymphoma - Mycosis fungoides (MF)/Sezary syndrome (SS) - Primary Cutaneous B-Cell Lymphoma . Reauthorization for treatment of Non-Hodgkin’s Lymphoma (NHL) will be issued/approved for 12 months based on of the following criteria: - Patient does not show evidence of progressive disease while on Targretin gel therapy Technivie (Ombitasvir/ Revised  Revised prior authorization/medical necessity guidelines; modified Paritaprevir/Ritonavir) coverage criteria: o Updated coverage criteria based on review of recently published information/data Test Strips (Diabetic) Revised  Updated medication/drug name; previously listed as “Test Strips (Diabetic): Accu-Chek Nano (Accu-Chek Smartview test strips), Accu-Chek Aviva (Accu-Chek Aviva Plus test strips), One Touch Ultra (One Touch Ultra test strips), One Touch Verio IQ (One Touch Verio test strips)”  Added state specific prior authorization/notification guidelines for New Jersey plans (precertification requirements apply); refer to Prior Authorization/Notification Guidelines: Diabetic Test Strips (NJ) for

59 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Test Strips (Diabetic) Revised complete details on applicable coverage criteria Guidelines (continued) (continued) Testim (Testosterone Revised  Revised prior authorization/medical necessity guidelines (see Prior Gel) Authorization/Medical Necessity Guidelines: Testim): o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy Testosterone Topical Gel Updated  Updated prior authorization/medical necessity guidelines (see Prior (Generic Vogelxo) Authorization/Medical Necessity Guidelines: Topical Androgens): o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy” Testosterone Topical Gel Updated  Updated prior authorization/medical necessity guidelines (see Prior (Manufacturer of Perrigo Authorization/Medical Necessity Guidelines: Topical Androgens): Israel) o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy” Tirosint (Levothyroxine Revised  Revised coverage criteria/precertification requirements: Sodium) o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with levothyroxine or Synthroid (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and

60 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Tirosint (Levothyroxine Revised Therapeutic Equivalent Medications) Guidelines Sodium) (continued) (continued) Uloric (Febuxostat) New  Added step therapy guidelines to indicate authorization will be issued/approved for 60 months based on a history, contraindication or intolerance to the following (see Step Therapy Guidelines: Uloric): o Allopurinol (generic Zyloprim) Varubi (Rolapitant) New  Added coverage criteria/precertification requirements: o Added language to indicate precertification is required through the Pharmacy Benefit Manager (PBM) o Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with granisetron (generic Kytril), ondansetron (generic Zofran), Anzemet, or Emend (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications) Viekira Pak (Ombitasvir, Revised  Revised prior authorization/medical necessity guidelines; modified Paritaprevir (ABT-450) coverage criteria: and Ritonavir) o Updated coverage criteria based on review of recently published information/data Vogelxo (Testosterone) Revised  Updated prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Vogelxo): o Updated initial authorization criteria; added language to clarify authorization will be issued for: . 6 months for patients new to any topical testosterone therapy; or . 12 months for patients continuing testosterone therapy o Updated reauthorization criteria; added language to indicate follow-up testosterone level should be drawn within the past: . 6 months for patients new to testosterone therapy; or . 12 months for patients continuing testosterone therapy Xeljanz (Tofacitinib) Revised  Revised step therapy guidelines (see Step Therapy Guidelines: Xeljanz) o Modified coverage criteria for treatment of rheumatoid arthritis (RA); replaced criterion requiring “patient has not received a manufacturer supplied sample at no cost as a means to establish as a current user of Xeljanz” with “patient has not received a manufacturer supplied sample at no cost from a prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Xeljanz” Xifaxan (Rifaximin) Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Xifaxan):

61 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Xifaxan (Rifaximin) Revised o Updated background information Guidelines (continued) o Revised initial authorization criteria for treatment of irritable bowel (continued) syndrome with diarrhea (IBS-D): . Updated list of products to which history of failure, contraindication, or intolerance must be demonstrated: - Added “selective serotonin reuptake inhibitor (SSRI) (e.g., sertraline)” - Removed “antispasmodic (e.g., dicyclomine, hyoscyamine)” . Changed initial authorization approval timeframe from “1 time” to “14 days” o Added reauthorization criteria to indicate authorization will be issued/approved for 14 days based on all of the following criteria: . Patient has experienced a recurrence of IBS-D after a prior 14 day course of therapy with Xifaxan . Patient has had a treatment-free period between courses of therapy . Patient has not already received 3 treatment courses of Xifaxan for IBS-D in the previous 6 months Xigduo XR (Dapagliflozin Revised  Revised coverage criteria/precertification requirements to indicate and Metformin HCL) precertification is no longer required: o Removed language indicating precertification is required through the Pharmacy Benefit Manager (PBM) o Removed therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with a formulary alternative (Invokana or Invokamet) and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications Zohydro ER Revised  Revised prior authorization/medical necessity guidelines (see Prior (Hydrocodone Bitartrate Authorization/Medical Necessity Guidelines: Zohydro ER): Extended Release) o Updated background information; added language detailing FDA approved age ranges for long-acting opioids o Revised coverage criteria: . Added criterion for patients less than 18 years and using the medication within the FDA approved age range for the prescribed medication . Added language to clarify which brand and generic versions of listed products are included in the criteria (e.g., which generic morphine sulfate product is preferred and which are non-preferred) Zontivity (Vorapaxar) Updated  Updated background information and references; no change to coverage guidelines

62 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Zovirax Ointment Updated  Routine review; no content changes Guidelines Zubsolv (Buprenorphine/ Revised  Revised prior authorization/medical necessity guidelines (see Prior (continued) Naxolone) Authorization/Medical Necessity Guidelines: Zubsolv): o Revised coverage criteria to indicate authorization will be issued/approved for 12 months based on all of the following criteria: . The physician has been issued a unique DEA identification number, indicating that he/she is a qualified physician under DATA 2000 to prescribe buprenorphine products; and . The patient is being treated for opioid dependence; and . The medication is not being used solely for pain management Zyban (Bupropion) Revised  Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Tobacco Cessation for Health Care Reform): o Added notation to indicate pharmacist review is required for more than 2 cycles per 12 month period (one cycle is defined as more than 1 month of medication; if only one month of medication is filled, 2 additional cycles of medication may be authorized in the 12 month period) Zydelig (Idelalisib) Revised  Revised prior authorization/notification guidelines (see Prior Authorization/Notification Guidelines: Zydelig): o Updated background information o Reformatted and revised coverage criteria for the treatment of Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL); removed initial authorization criterion requiring: . Use in combination with Rituxan (rituximab) . Patient is a candidate for Rituxan (rituximab) monotherapy due to presence of other comorbidities (e.g., coronary artery disease, peripheral vascular disease, diabetes mellitus, pulmonary disease [COPD], etc.) . History of failure, contraindication, or intolerance to at least two prior systemic therapies o Reformatted and revised coverage criteria for the treatment of Non- Hodgkin Lymphoma (NHL); . Changed service sub-header; previously named Follicular Lymphoma (FL) . Revised initial authorization criteria to indicate approval is based on: - Both of the following:  Diagnosis of one of the following: o Follicular lymphoma (FL)

63 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Drug/Medication Status Summary of Changes Drug Coverage Jan. 1, 2016 Zydelig (Idelalisib) Revised o Gastric MALT Lymphoma Guidelines (continued) o Nongastric MALT Lymphoma (continued) o Splenic Marginal Zone Lymphoma and  Not used as first-line therapy or - Diagnosis of one of the following:  Primary cutaneous marginal zone lymphoma  Follicle center refractory generalized cutaneous B-cell lymphoma  Relapsed generalized extracutaneous B-cell lymphoma Zyrtec (Cetirizine) New  Added coverage guidelines to indicate: Solution o Precertification is not required o Prescription drugs for which there is a therapeutic over-the-counter (OTC) equivalent are excluded from coverage; refer to the Member's benefit document as applicable

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016  Revised coverage rationale: Definitions: Please note, for the purpose of this policy: Hereditary Breast o Updated/clarified definition of: 1. Close blood relatives are defined as follows: and/or Ovarian . Breast cancer diagnosis A. First degree relatives include parents, sibling and offspring Cancer Syndrome . Documentation of personal B. Second degree relatives include half-brothers/sisters, aunts/uncles, (HBOC) and family history grandparents grandchildren and nieces/nephews affected all on the . Gleason scoring system same side of the family . Triple-negative breast cancer C. Third degree relatives include first cousins, great-aunts/uncles, o Added coverage great-grandchildren and great grandparents affected all on same criteria/requirements for side of family genetic counseling to indicate: 2. A breast cancer diagnosis includes either invasive carcinomas or non- . Genetic counseling is invasive (in situ) ductal carcinoma types. required by an independent 3. Ovarian cancer also includes fallopian tube cancers and primary (not employed by a genetic peritoneal carcinoma. testing lab) genetics provider 4. Limited family history is defined as having fewer than two known first- prior to genetic testing for degree or second-degree female relatives or female relatives surviving BRCA mutations in order to beyond 45 years of age on either or both sides of the family. (e.g. inform persons being tested individual who is adopted). about the benefits and 5. Documentation of personal and family history, in the form of a pedigree limitations of a specific drawing/diagram utilizing standardized nomenclature, should be in the genetic test as applied to a contemporaneous medical records submitted with the testing request

64 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016 unique person (i.e., request form). Hereditary Breast . Genetics providers employed 6. For the statements that include age guidelines, a person is considered to and/or Ovarian by or contracted with a be 45 years of age up until the day before their 46th birthday, and a Cancer Syndrome laboratory that are part of an person is considered to be 50 years of age up until the day before their (HBOC) integrated health system 51st birthday. (continued) that routinely delivers health 7. Two breast primary cancers include cancers appearing at the same time care services beyond the (synchronous) and one is not a metastasis of the other; or primary laboratory testing itself are cancers developing at different times (metachronous or asynchronous). considered independent The tumors may be in one or two breasts. . Genetic testing for BRCA 8. Gleason scoring is a system of grading prostate cancer tissue based on mutations requires how it looks under a microscope. Gleason scores range from 2 to 10 and documentation of medical indicate how likely it is that a tumor will spread. A low Gleason score necessity by one of the means the cancer tissue is similar to normal prostate tissue and the following who has evaluated tumor is less likely to spread. A high Gleason score means the cancer the member and intends to tissue is very different from normal and the tumor is more likely to engage in post-test follow-up spread. counseling: 9. HBOC - associated malignancies include prostate cancer, (Gleason score - Board-Eligible or Board- ≥7), pancreatic cancer or melanoma. The presence of these Certified Genetic malignancies does not necessarily justify BRCA testing. For example, a Counselor (CGC) female with breast cancer over age 50 whose sister had melanoma at 40 - Advanced Genetics Nurse and whose father has prostate cancer (Gleason score ≥7) would meet (AGN-BC) criteria. In another example, a female with breast cancer over age 50 - Genetic Clinical Nurse whose maternal aunt had pancreatic cancer and whose paternal uncle (GCN) had prostate cancer (Gleason score ≥7) would not meet criteria because - Advanced Practice Nurse the aunt and uncle are on different sides of the family. in Genetics (APNG) 10. Triple-negative breast cancer refers to any breast cancer that does not - A Board-Eligible or Board- show expression of estrogen receptor (ER), progesterone receptors (PR) Certified Clinical or HER2/neu. This subtype of breast cancer is clinically characterized as Geneticist more aggressive and less responsive to standard treatment and is - A Board-Certified associated with poorer overall patient prognosis. It is diagnosed more physician with experience frequently in younger women, women with BRCA1 mutations and those in cancer genetics belonging to African-American and Hispanic ethnic groups. (defined as providing cancer risk assessment on Genetic Counseling a regular basis and having Genetic counseling is required by an independent (not employed by a received specialized genetic testing lab) genetics provider prior to genetic testing for BRCA ongoing training in cancer mutations in order to inform persons being tested about the benefits and genetics) limitations of a specific genetic test as applied to a unique person. Genetics . Documentation requirements

65 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016 include: providers employed by or contracted with a laboratory that are part of an Hereditary Breast - Three generation pedigree integrated health system that routinely delivers health care services beyond and/or Ovarian - UnitedHealthcare genetic the laboratory testing itself are considered independent. Genetic testing for Cancer Syndrome counseling attestation BRCA mutations requires documentation of medical necessity by ONE of the (HBOC) form following who has evaluated the member and intends to engage in post-test (continued) o Revised BRCA testing criteria: follow-up counseling: . Added language to indicate:  Board-Eligible or Board-Certified Genetic Counselor (CGC) - National Comprehensive  Advanced Genetics Nurse (AGN-BC) Cancer Network (NCCN)  Genetic Clinical Nurse (GCN) guidelines state that  Advanced Practice Nurse in Genetics (APNG) meeting one or more of  A Board-Eligible or Board-Certified Clinical Geneticist these criteria warrants  A Board-Certified physician with experience in cancer genetics (defined further personalized risk as providing cancer risk assessment on a regular basis and having assessment, genetic received specialized ongoing training in cancer genetics). counseling and consideration of genetic Documentation requirements: testing  Three generation pedigree - Comprehensive  UnitedHealthcare genetic counseling attestation form BRCA1/BRCA2 genetic testing includes BRCA Testing Criteria

sequencing of both BRCA1 Note: National Comprehensive Cancer Network (NCCN) guidelines state and BRCA2 genes and that meeting one or more of these criteria warrants further personalized analysis for large genomic risk assessment, genetic counseling and consideration of genetic testing. rearrangements, either concurrently or Comprehensive BRCA1/BRCA2 genetic testing includes sequencing of both sequentially; NCCN BRCA1 and BRCA2 genes and analysis for large genomic rearrangements, guidelines emphasize the either concurrently or sequentially. NCCN guidelines emphasize the need for need for comprehensive comprehensive testing for individuals who meet the testing criteria for testing for individuals who BRCA1/BRCA2 and have no known familial BRCA1/BRCA2 mutations who meet the testing criteria have undergone accurate risk assessment and genetic counseling. for BRCA1/BRCA2 and have no known familial I. BRCA1 and BRCA2 testing is proven and medically necessary for BRCA1/BRCA2 mutations women with a personal history of breast cancer in the following who have undergone situations and where gene testing results will impact medical accurate risk assessment management: and genetic counseling A. Breast cancer diagnosed at age 45 or younger with or without family . Revised testing criteria for history; or women with a personal

history of breast cancer to

66 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016 indicate BRCA1 and BRCA2 B. Breast cancer diagnosed at age 50 or younger with: Hereditary Breast testing is proven and 1. An additional primary breast cancer; or and/or Ovarian medically necessary for 2. At least one close blood relative with breast cancer at any age; Cancer Syndrome women with a personal or (HBOC) history of breast cancer in 3. At least one close blood relative with pancreatic cancer; or (continued) the following situations and 4. At least one close blood relative with prostate cancer (Gleason where gene testing results score ≥7; or will impact medical 5. An unknown or limited family history (see Definitions section of management: the policy for further clarification of limited family history)

A. Breast cancer diagnosed C. Breast cancer diagnosed at any age with: at age 45 or younger with 1. At least one close blood relative with breast cancer diagnosed at or without family history; age 50 or younger; or or 2. At least two close blood relatives on the same side of the family B. Breast cancer diagnosed with breast cancer at any age; or at age 50 or younger 3. At least one close blood relative with ovarian cancer at any age; with: or 1. An additional primary 4. At least two close blood relatives on the same side of the family breast cancer; or with pancreatic and/or prostate cancer (Gleason score ≥7) at 2. At least one close any age; or blood relative with 5. Close male blood relative with breast cancer; or breast cancer at any 6. At least one close blood relative who has a BRCA1 or BRCA2 age; or mutation (Testing should be targeted to the known 3. At least one close BRCA1/BRCA2 mutation in the family. Further BRCA1/BRCA2 blood relative with testing should only be pursued if the results are negative and the pancreatic cancer; or patient otherwise meets testing criteria); or 4. At least one close 7. Ashkenazi Jewish or ethnic groups associated with founder blood relative with mutations. Testing for Ashkenazi Jewish founder-specific prostate cancer mutations should be performed first. Further BRCA1/BRCA2 (Gleason score ≥7; or testing should only be pursued if the results are negative and the 5. An unknown or limited patient otherwise meets testing criteria without considering family history Ashkenazi Jewish ancestry. C. Breast cancer diagnosed D. Triple-negative breast cancer diagnosed at age 60 or younger. at any age with:

1. At least one close II. BRCA1 and BRCA2 testing is proven and medically necessary for blood relative with women with a personal history of ovarian cancer. breast cancer

diagnosed at age 50 or III. BRCA1 and BRCA2 testing is proven and medically necessary for younger; or women and men with a personal history of pancreatic cancer at 2. At least two close

67 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016 blood relatives on the any age and at least one close blood relative on the same side of Hereditary Breast same side of the the family with breast (≤ age 50 years), ovarian, pancreatic and/or Ovarian family with breast and/or prostate cancer (Gleason score ≥7) at any age. Cancer Syndrome cancer at any age; or (HBOC) 3. At least one close IV. BRCA1 and BRCA2 testing for Ashkenazi Jewish founder-specific (continued) blood relative with mutations (a gene mutation observed with high frequency in a ovarian cancer at any group that is or was geographically or culturally isolated, in age; or which one or more of the ancestors was a carrier of the mutant 4. At least two close gene) is proven and medically necessary for women and men blood relatives on the with a personal history of pancreatic cancer and Ashkenazi same side of the Jewish ancestry. family with pancreatic and/or prostate cancer V. BRCA1 and BRCA2 testing is proven and medically necessary for (Gleason score ≥7) at men with a personal history of prostate cancer (Gleason score any age; or ≥7) at any age and at least one close blood relative on the same 5. Close male blood side of the family with breast (≤ age 50 years), ovarian, relative with breast pancreatic and/or prostate cancer (Gleason score ≥7) at any cancer; or age. 6. At least one close blood relative who has VI. BRCA1 and BRCA2 testing is proven and medically necessary for a BRCA1 or BRCA2 men with a personal history of breast cancer. mutation (testing should be targeted to VII.BRCA1 and BRCA2 screening tests are proven and medically the known necessary for men and women without a personal history of BRCA1/BRCA2 breast or ovarian cancer with at least one of the following mutation in the family; familial risk factors only when there are no family members further BRCA1/BRCA2 affected with a BRCA associated cancer available for testing (see testing should only be Note below):

pursued if the results A. At least one first- or second-degree blood relative meeting any of are negative and the the above criteria (I-V); or patient otherwise B. At least one third-degree blood relative with breast cancer and/or meets testing criteria); ovarian cancer who has at least 2 close blood relatives with breast or cancer (at least one with breast cancer at age 50 or younger) and/or 7. Ashkenazi Jewish or ovarian cancer; or ethnic groups C. A known BRCA1/BRCA2 mutation in a blood relative (defined as first- associated with , second- or third-degree relative). Testing should be targeted to the founder mutations. known BRCA1/BRCA2 mutation in the family. Further BRCA1/BRCA2 Testing for Ashkenazi testing should only be pursued if the results are negative and the Jewish founder-specific

68 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016 mutations should be patient otherwise meets testing criteria. Hereditary Breast performed first; and/or Ovarian further BRCA1/BRCA2 Note: NCCN guidelines state that significant limitations of interpreting test Cancer Syndrome testing should only be results for an unaffected individual should be discussed. If there are no (HBOC) pursued if the results living family members with breast or ovarian cancer available for testing, (continued) are negative and the consider testing family members affected with other cancers associated with patient otherwise BRCA1/BRCA2, such as prostate cancer (Gleason score ≥7), pancreatic meets testing criteria cancer or melanoma. Testing of unaffected individuals should only be without considering considered when there is no affected family member available for testing Ashkenazi Jewish (NCCN, 2015). ancestry D. Triple-negative breast VIII. BRCA1 and/or BRCA2 testing is unproven and not medically cancer diagnosed at age necessary for all other indications including: 1) screening for 60 or younger breast or ovarian cancer risk for individuals not listed in the . Revised criteria for women proven indications above or 2) for risk assessment of other and men with a personal cancers. history of pancreatic Further evidence is needed to establish the clinical utility of testing in cancer to indicate BRCA1 other populations. and BRCA2 testing is proven and medically necessary for women and men with a personal history of pancreatic cancer at any age and at least one close blood relative on the same side of the family with breast (≤ age 50 years), ovarian, pancreatic and/or prostate cancer (Gleason score ≥7) at any age . Added criteria for Ashkenazi Jewish founder-specific mutations to indicate BRCA1 and BRCA2 is proven and medically necessary for women and men with a personal history of pancreatic cancer and Ashkenazi Jewish ancestry

69 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016 . Revised criteria for men Hereditary Breast with a personal history of and/or Ovarian prostate cancer to indicate Cancer Syndrome BRCA1 and BRCA2 testing is (HBOC) proven and medically (continued) necessary for men with a personal history of prostate cancer (Gleason score ≥7) at any age and at least one close blood relative on the same side of the family with breast (≤ age 50 years), ovarian, pancreatic and/or prostate cancer (Gleason score ≥7) at any age . Revised criteria for men and women without a personal history of breast or ovarian cancer to indicate: - BRCA1 and BRCA2 screening tests are proven and medically necessary men and women without a personal history of breast or ovarian cancer with at least one of the following familial risk factors only when there are no family members affected with a BRCA associated cancer available for testing: A. At least one first- or second-degree blood relative meeting any of the above criteria (I- V); or B. At least one third-

70 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016 degree blood relative Hereditary Breast with breast cancer and/or Ovarian and/or ovarian cancer Cancer Syndrome who has at least 2 (HBOC) close blood relatives (continued) with breast cancer (at least one with breast cancer at age 50 or younger) and/or ovarian cancer; or C. A known BRCA1/BRCA2 mutation in a blood relative (defined as first-, second- or third- degree relative) o Testing should be targeted to the known BRCA1/BRCA2 mutation in the family o Further BRCA1/BRCA2 testing should only be pursued if the results are negative and the patient otherwise meets testing criteria - NCCN guidelines state that significant limitations of interpreting test results for an unaffected individual should be discussed - If there are no living family members with breast or ovarian cancer

71 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Genetic Testing for Jan. 1, 2016 available for testing, Hereditary Breast consider testing family and/or Ovarian members affected with Cancer Syndrome other cancers associated (HBOC) with BRCA1/BRCA2, such (continued) as prostate cancer (Gleason score ≥7), pancreatic cancer or melanoma - Testing of unaffected individuals should only be considered when there is no affected family member available for testing (NCCN, 2015) o Removed criteria for large genomic rearrangement testing as this step is incorporated into comprehensive testing and may be done concurrently or sequentially  Updated list of applicable CPT codes to reflect annual code edits (effective Jan. 1, 2016); added 81162, 81432 and 81433  Removed “Additional Products” information listing specific genetic test device names and manufacturers  Updated supporting information to reflect the most current description of services, clinical evidence, FDA information and references Glaucoma Surgical Jan. 1, 2016  Revised coverage rationale; Glaucoma drainage devices, such as the ExPRESS™ mini glaucoma Treatments removed language indicating shunt, Molteno implant, Baerveldt tube shunt, Krupin Eye Valve, or transciliary fistulization is the Ahmed glaucoma valve implant, are proven and medically unproven and not medically necessary for treatment of refractory glaucoma when there is necessary for the treatment of intolerance, contraindication, or failure of topical or oral

72 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Glaucoma Surgical Jan. 1, 2016 glaucoma medication, when used according to U.S. Food and Drug Treatments  Updated list of applicable CPT Administration (FDA) labeled indications. (continued) codes to reflect annual code edits (effective Jan. 1, 2016); removed The iStent® Trabecular Micro-Bypass Stent System is proven and 0123T medically necessary when used in combination with cataract  Updated supporting information to surgery to treat mild to moderate open-angle glaucoma and a reflect the most current description cataract in adults currently being treated with ocular hypotensive of services, clinical evidence, FDA medication. information, and references Glaucoma drainage devices, such as, Eyepass, DeepLight SOLX® Gold Shunt and other shunts that do not have FDA approval are investigational and unproven and not considered to be medically necessary for the treatment of glaucoma. Clinical evidence is limited to small studies; therefore, additional studies are needed to establish the safety and efficacy of these devices.

Canaloplasty is proven and medically necessary for the treatment of primary open-angle glaucoma.

Viscocanalostomy is unproven and not medically necessary for the treatment of glaucoma. Evidence from the majority of available randomized controlled trials indicates that viscocanalostomy is not as effective as trabeculectomy in reducing intraocular pressure (IOP). Immune Globulin Jan. 1, 2016  Revised utilization management Introduction

Site of Care Review guiding principles/introduction This guideline addresses the criteria for consideration of allowing hospital Guidelines for language to indicate this guideline outpatient facility infusion service for immune globulin (IVIG and SCIG) Medical Necessity addresses the criteria for therapy. This includes hospital based services with the following CMS/AMA of Hospital consideration of allowing hospital Place of Service codes: Outpatient Facility outpatient facility infusion service  22 On Campus-Outpatient Hospital, and Infusion for immune globulin (IVIG and  19 Off Campus-Outpatient Hospital SCIG) therapy; this includes hospital based services with the Criteria and Clinical Indications for Hospital Outpatient Site of Care following CMS/AMA Place of Selection Service codes: Criteria: When requested, hospital outpatient site of care may be approved o 22 on campus-outpatient when: hospital; and  Any of the clinical indications questions 1-8 below can be answered o 19 off campus-outpatient ‘yes’; and

73 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Immune Globulin Jan. 1, 2016 hospital  The provider has submitted the appropriate supporting documentation. Site of Care Review Guidelines for Clinical Indications: See the above criteria for the following questions. Medical Necessity Note: If more than one of the criteria addressed in the questions below are of Hospital met, then the greatest of the applicable approval time periods will be Outpatient Facility allowed. Infusion 1. Is this the patient’s initial infusion of immune globulin or re-initiation (continued) after more than 6 months off of immune globulin? 2. Is the patient changing immune globulin products? 3. Has the patient previously experienced a severe adverse event to immune globulin (examples might include, but are not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, and renal failure, other – provide reaction)? 4. Is the patient clinically unstable? 5. Is the patient continually experiencing moderate or severe adverse events not able to be mitigated by use of acetaminophen, steroids, diphenhydramine, fluids or other pre-medications on therapy? 6. Has the patient had an adverse event not able to be mitigated by use of acetaminophen, steroids, diphenhydramine, fluids or other pre- medications to immune globulin therapy documented for which the physician is uncomfortable administering immune globulin in a home or ambulatory setting? 7. Is the patient physically or cognitively disabled to the point where receiving treatment in at home or in a physician office would present a risk to their health? 8. Does the patient have immunoglobulin A (IgA) deficiency with anti-IgA antibodies?

Supporting Information and Clinical Evidence 1. Clinical use of Immune globulin use is medically necessary according to the Oxford Health Plans Drug Policy for Immune Globulin (IVIG and SCIG). See policy: Immune Globulin (IVIG and SCIG) 2. With respect to the site of care there are several options for administering immune globulin and should be based on patient clinical characteristics a. Hospital inpatient physician/nurse supervised infusion b. Hospital outpatient physician/nurse supervised infusion c. Physician office based physician/nurse supervised infusion

74 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Immune Globulin Jan. 1, 2016 d. Home based infusion with nurse supervision Site of Care Review e. Home based infusion without nurse supervision Guidelines for 3. Immune Globulin infusion is widely used throughout the various sites of Medical Necessity care. of Hospital According to a 2008 survey by the Immune Deficiency Foundation of Outpatient Facility 1,030 patients being treated with immune globulin, two out of five Infusion (42%) IVIG users reported that they usually received their infusion at (continued) home. Of those, 7% were able to self-infuse, while the other 35% had a nurse perform the infusion. Twenty-six percent of IVIG users usually got their infusion at a hospital outpatient department (21%), or at a hospital clinic (5%). Most of the remainder said that they usually got their infusion in a doctor’s private office (9%) or an infusion suite (16%). 4. Home infusion as a place of service is well established and accepted by physicians A 2010 home infusion provider survey by the National Home Infusion Association reported providing 1.24 million therapies to approximately 829,000 patients, including 129,071 infusion therapies of specialty medications, which includes immune globulin. Injectable Feb. 1, 2016  Added conditions of coverage/ Oxford has engaged eviCore Healthcare to perform precertification* reviews Chemotherapy authorization requirements to for injectable chemotherapy drugs administrated by participating providers Drugs: Application indicate precertification is required in an office, outpatient or home setting to treat a cancer diagnosis. Oxford of NCCN Clinical for injectable chemotherapy drugs continues to be responsible for claims payment decisions and for appeals.

Practice Guidelines through eviCore Healthcare o Precertification is required for Note: Precertification is not required for injectable chemotherapy drugs services covered under the administrated by a non-participating provider in an office or outpatient Member's General Benefits setting however precertification will be provided upon request. package when performed in the office of a participating provider All precertification requests for injectable chemotherapy drugs are handled . For Commercial plans, by eviCore Healthcare. To obtain precertification for injectable precertification is not chemotherapy medications providers must contact CCN. Providers are

required, but is encouraged encouraged to obtain precertification on line by logging in to for out-of-network services OxfordHealth.com and selecting the link to the eviCore Healthcare performed in the office that authorization web site. Providers may also obtain precertification by calling are covered under the 1-877-773-2882. Member's General Benefits package eviCore Healthcare uses the National Comprehensive Cancer Network’s . If precertification is not (NCCN) guidelines in their decision making process. These guidelines obtained, Oxford may review provide independent recommendations for evidence-based cancer

75 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Injectable Feb. 1, 2016 for medical necessity after treatment. The guidelines are continually updated to be consistent with the Chemotherapy the service is rendered current treatment options. Providers and patients may access and view the Drugs: Application o Precertification is required for NCCN guidelines at NCCN.org. of NCCN Clinical injectable chemotherapy drugs Practice Guidelines administrated by a participating Oxford recognizes indications and uses of oncology medications listed in the (continued) provider in an office, outpatient NCCN Drugs and Biologics Compendium with Categories of Evidence and or home setting Consensus of 1, 2A, and 2B as proven and medically necessary and . Precertification is not Categories of Evidence and Consensus of 3 as unproven and not medically required for injectable necessary. chemotherapy drugs administrated by a non- *The term “Precertification” is also referred to as “Prior Authorization”. You participating provider in an may notice both terms are used, both are the same. office and outpatient setting however precertification will Additional Information

be provided upon request The NCCN Clinical Practice Guidelines in Oncology™ (NCCN Guidelines®) are  Updated benefit considerations: a comprehensive set of guidelines documenting sequential management o Removed language indicating decisions and interventions that apply to malignancies which affect about this policy does not apply to 97% of all patients with cancer. They also address supportive care issues. Members younger than 19 The guidelines are developed and updated by 47 individual panels, years of age composed of more than 950 clinicians and oncology researchers from the  Revised coverage rationale: 25 NCCN member institutions and their affiliates. o Added language to indicate: . Oxford has engaged eviCore NCCN Categories of Evidence and Consensus Healthcare to perform  Category 1: The recommendation is based on high-level evidence (i.e., precertification reviews for high-powered randomized clinical trials or meta-analyses), and the panel injectable chemotherapy has reached uniform consensus that the recommendation is indicated. In drugs administrated in an this context, uniform means near unanimous positive support with some outpatient setting to treat a possible neutral positions. cancer diagnosis; Oxford

continues to be responsible  Category 2A: The recommendation is based on lower level evidence, for claims payment decisions but despite the absence of higher level studies, there is uniform and for appeals consensus that the recommendation is appropriate. Lower level evidence . All precertification requests is interpreted broadly, and runs the gamut from phase II to large cohort for injectable chemotherapy studies to case series to individual practitioner experience. Importantly, drugs are handled by eviCore in many instances, the retrospective studies are derived from clinical Healthcare experience of treating large numbers of patients at a member - To obtain precertification institution, so panel members have first-hand knowledge of the data. for injectable Inevitably, some recommendations must address clinical situations for chemotherapy

76 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Injectable Feb. 1, 2016 medications providers which limited or no data exist. In these instances the congruence of Chemotherapy must contact eviCore experience-based opinions provides an informed if not confirmed Drugs: Application Healthcare direction for optimizing patient care. These recommendations carry the of NCCN Clinical - Providers are encouraged implicit recognition that they may be superseded as higher level Practice Guidelines to obtain precertification evidence becomes available or as outcomes-based information becomes (continued) on line by logging in to more prevalent.

OxfordHealth.com and  Category 2B: The recommendation is based on lower level evidence, selecting the link to the and there is nonuniform consensus that the recommendation should be eviCore Healthcare made. In these instances, because the evidence is not conclusive, authorization web site institutions take different approaches to the management of a particular - Providers may also obtain clinical scenario. This nonuniform consensus does not represent a major precertification by calling disagreement rather it recognizes that given imperfect information, 1-877-773-2882 institutions may adopt different approaches. A Category 2B designation . eviCore Healthcare uses the should signal to the user that more than one approach can be inferred National Comprehensive from the existing data. Cancer Network’s (NCCN)  Category 3: The recommendation has engendered a major guidelines in their decision disagreement among the panel members. Several circumstances can making process cause major disagreements. For example, if substantial data exists - These guidelines provide about two interventions but they have never been directly compared in a independent randomized trial, adherents to one set of data may not accept the recommendations for interpretation of the other side's results. Another situation resulting in a evidence-based cancer Category 3 designation is when experts disagree about how trial data treatment can be generalized. A Category 3 designation alerts users to a major - The guidelines are interpretation issue in the data and directs them to the manuscript for continually updated to be an explanation of the controversy. consistent with the

current treatment options If the drug regimen being requested does not have a NCCN 1, 2a, or 2b - Providers and patients NCCN Guideline recommendation, refer to the following Oxford policies: may access and view the NCCN guidelines at  Clinical Trials NCCN.org  Experimental/Investigational Treatment . “Precertification” is also  Experimental/Investigational Treatment for NJ Plans referred to as “Prior Authorization”; these terms Facilities, physicians and other health care professionals are encouraged to are used interchangeably utilize the most appropriate ICD-10-CM diagnosis codes in accordance with o Removed language indicating: applicable code set guidelines. . Oxford will cover all chemotherapy agents for individuals under the age of

77 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Injectable Feb. 1, 2016 19 years for oncology Chemotherapy indications; the majority of Drugs: Application pediatric patients receive of NCCN Clinical treatments on national Practice Guidelines pediatric protocols that are (continued) quite similar in concept to the NCCN patient care guidelines . While precertification is not required for injectable chemotherapy drugs, Oxford will provide a pre-service clinical review and coverage determination upon request . In the absence of precertification for injectable chemotherapy drugs, Oxford will perform a post-service retrospective review upon claim submission; medical necessity is determined via the guidelines described in this policy, and may be reviewed in conjunction with one or more of the following Oxford policies . Chemotherapy drugs used in the treatment of diagnoses listed on the Exceptions to Cancer Diagnosis Codes List are not subject to clinical review and will be reimbursed in accordance with a Member's health benefits plan  Added content/language pertaining to Applicable Codes: o Added list of HCPCS codes included in the eviCore

78 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Injectable Feb. 1, 2016 Healthcare arrangement Chemotherapy (requiring precertification Drugs: Application effective 02/01/2016) of NCCN Clinical o Added notation to refer to the Practice Guidelines following policies for details on (continued) applicable coverage guidelines for injectable chemotherapy drugs utilized for non-oncology indications: . J9010: Alemtuzumab . J9217: Lupron- Depot/Lupron-Depot (Leuprolide Acetate) . J9310: Rituxan (Rituximab)  Added a “description of services” addressed in the policy Lupron-Depot / Jan. 1, 2016  Reformatted and revised coverage Please refer to the Injectable Chemotherapy Drugs: Application of NCCN Lupron-Depot Ped rationale: Clinical Practice Guidelines Policy for updated information based on the (Leuprolide o Replaced references to National Comprehensive Cancer Network (NCCN) Drugs & Biologics Acetate) “leuprolide acetate” with Compendium® (NCCN Compendium®) for oncology indications. “Lupron Depot” This policy refers to the following leuprolide acetate drug products: o Updated list of proven  Lupron Depot indications; added language to  Lupron Depot-Ped indicate:

. Lupron Depot is medically Lupron Depot is proven for: necessary for fertility preservation when the Central Precocious Puberty following criteria are met: Additional information to support medical necessity review: - For use in pre- menopausal women; Lupron Depot is medically necessary for the treatment of central and precocious puberty when all of the following criteria are met: - Patient is receiving a  Diagnosis of central precocious puberty (idiopathic or neurogenic); and cytotoxic agent that is  Onset of secondary sexual characteristics in one of the following: associated with o Females ≤ 8 years of age causing primary o Males ≤9 years of age ovarian insufficiency and (premature ovarian  Confirmation of diagnosis as defined by one of the following: failure) [e.g., Cytoxan o Pubertal luteinizing hormone response to a GnRH stimulation test

79 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Lupron-Depot / Jan. 1, 2016 (cyclophosphamide), o Bone age advanced one year beyond the chronological age Lupron-Depot Ped procarbazine, (Leuprolide vinblastine, cisplatin] The Lupron Depot label states that treatment should be discontinued at the Acetate) . Lupron Depot therapy appropriate age of onset of puberty at the discretion of the physician. Give (continued) should be discontinued consideration to discontinuing treatment before 11 years of age in girls and upon the completion of 12 years of age in boys. treatment o Removed language indicating Endometriosis

the use of Lupron in Additional information to support medical necessity review: conjunction with Growth Hormone and Growth Lupron Depot is medically necessary for the treatment of Stimulating Products not endometriosis when both of the following criteria are met: associated with a medical  Diagnosis of endometriosis; and condition (such as Growth  One of the following: Hormone deficiency) for the o Contraindication, intolerance, or failure of initial treatment with oral purposes of increasing height contraceptives and non-steroidal anti-inflammatory drugs (NSAIDs) is not considered medically o Patient has had surgical ablation to prevent recurrence necessary and therefore, not covered The Lupron Depot label states that the duration of initial treatment or 2  Updated supporting information to retreatment for endometriosis should be limited to 6 months . For reflect the most current clinical recurrence of symptoms, leuprolide may be used in combination with evidence and references norethindrone acetate for 6 months; greater than one retreatment period is not recommended. Leuprolide monotherapy is not recommended for retreatment.

Uterine Leiomyomata (Fibroids)

Additional information to support medical necessity review:

Lupron Depot is medically necessary for the treatment of uterine

leiomyomata when one of the following criteria is met:

 All of the following:

o For the treatment of anemia; and

o Anemia is caused by uterine leiomyomata; and

o Patient did not respond to iron therapy of one month duration; and

o For use prior to surgery

or

 For use prior to surgery to reduce the size of fibroids to facilitate a

surgical procedure (e.g., myomectomy, hysterectomy)

80 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Lupron-Depot / Jan. 1, 2016 The recommended duration of therapy for the treatment of uterine Lupron-Depot Ped leiomyomata is ≤ 3 months. (Leuprolide Fertility Preservation Acetate) (continued) Additional information to support medical necessity review: Lupron Depot is medically necessary for fertility preservation when the following criteria are met:  All of the following: o For use in pre-menopausal women; and o Patient is receiving a cytotoxic agent that is associated with causing primary ovarian insufficiency (premature ovarian failure) [e.g., Cytoxan (cyclophosphamide), procarbazine, vinblastine, cisplatin]

Lupron Depot therapy should be discontinued upon the completion of treatment.

Unproven/Not Medically Necessary

Lupron Depot is unproven and not medically necessary for puberty suppression in patients with gender identity disorder due to the lack of long-term safety data. Statistically robust randomized controlled trials are needed to address the issue of whether the benefits outweigh the substantial inherent clinical risk in its use.

® Note: For coverage of Lupron 1 mg/0.2 mL subcutaneous formulation for Infertility (as part of an assisted reproductive technology protocol), notification to OptumHealth required in all sites of service, when associated with a specific infertility related ICD-9 diagnosis code. Refer to: Drug Coverage Guidelines.

Note: For coverage of Lupron 1mg/0.2mL for Cancer diagnoses, please refer to: Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines and Drug Coverage Guidelines.

Coverage for Lupron Depot® will be provided for Members as follows:

Medication/Drug Precertification by/Coverage Benefit

Lupron Depot® 3.75 mg Yes – Oxford’s Medical Medical

Management Department Benefit ® Lupron Depot 11.25 mg (3 Yes - Oxford’s Medical Medical month supply of the 3.75 Management Department Benefit mg dose)

81 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Lupron-Depot / Jan. 1, 2016 Lupron Depot® 7.5 mg No precertification required Medical Lupron-Depot Ped Benefit (Leuprolide Lupron Depot 22.5® mg (3 No precertification required Medical Acetate) month supply of the 7.5 mg Benefit (continued) dose) Lupron Depot® 30 mg (4 month supply of the 7.5 mg dose) Lupron® Depot Pediatric 7.5 Yes – Oxford’s Medical Medical mg Management Department Benefit Lupron® Depot Pediatric Note: Medical Director review 11.25 mg required Lupron® Depot Pediatric 15 mg

Omnibus Codes Jan. 1, 2016  Updated coverage rationale for the Refer to the policy for complete details on the coverage guidelines for following unproven/not medically Omnibus Codes. necessary procedure: Implantable cardiac devices for percutaneous closure (occlusion) of the left atrial appendage (LAA) (CPT code 0281T) o Replaced reference to “cardiac devices” with “implantable cardiac devices”  Revised coverage rationale to reflect annual code edits (effective Jan. 1, 2016): o Added language to indicate the

following procedures are unproven/not medically

necessary: . Use of intra-operative kinetic

balance sensor for implant stability during knee replacement arthroplasty (CPT code 0396T) . Magnetic resonance image

82 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Omnibus Codes Jan. 1, 2016 guided high intensity focused (continued) ultrasound (MRgFUS) intracranial stereotactic ablation (CPT code 0398T) . Multi-spectral digital skin lesion analysis (CPT codes 0400T and 0401T) . Collagen cross-linking of cornea analysis (CPT code 0402T) . Cardiac contractility modulation using an implantable device (CPT codes 0408T – 0418T) . Transurethral waterjet ablation of the prostate (CPT code 0421T) . Implantable neurostimulation devices for the treatment of central sleep apnea (CPT codes 0424T – 0436T) o Updated list of applicable CPT codes for the following procedures: Instrument-based ocular screening using photoscreening . Added 99177 . Added list of allowable diagnoses High dose rate electronic brachytherapy . Added 0394T and 0395T . Removed 0182T Serum proteomic profiling using mass spectrometry . Added 81538 Bioelectrical impedance analysis whole body

83 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Omnibus Codes Jan. 1, 2016 composition assessment (continued) . Revised description for 0358T Radiostereometric analysis in bone . Revised description for 0348T, 0349T, and 0350T Optical coherence tomography (OCT) . Revised description for 0352T and 0354T o Removed language indicating the following procedures are unproven and not medically necessary: . Testing for vitamin B-12 deficiency with a quantitative Holotranscobalamin testing (CPT code 0103T) . Use of computer-aided electronic auscultatory (acoustic cardiography) devices (CPT codes 0223T, 0224T, and 0225T) . Use of advanced glycation end products as a diagnostic or predictive test (CPT code 0233T) . Use of intermittent or continuous computerized wheeze detectors (CPT codes 0243T and 0244T)  Updated supporting information to reflect the most current clinical evidence and references

84 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Prescription Drug Jan. 1, 2016  Revised information pertaining to If a Member's prescription exceeds the supply limit, the pharmacist will be Quantity Duration applicable line of notified of the quantity covered for one copayment or for a specific time (QD) and Quantity business/products: period. Members will then have the following options: Level Limitations o Updated list of drugs included in  Accept the established supply limits (QLL) the select designated pharmacy  Discuss alternatives with the prescribing physician or other health care program for New York plan practitioner before deciding whether to fill or accept the prescription members; removed  Pay additional out-of-pocket cost(s) or copayment(s) for amounts that “Maxalt/Maxalt MLT” and exceed the supply limits, as appropriate “Zomig/Zomig ZMT” from list of  Member or prescribing physician or other health care practitioner may non-preferred agents request precertification or authorization for the additional amounts o Replaced reference to preferred through the coverage review process administered by the PBM, where alternative agent “Relpax” with available “rizatriptan” Preventive Care Jan. 1, 2016  Revised coverage Refer to the policy for complete details on the coverge guidelines for Services rationale/indications for coverage: Preventive Care Services. Women’s Health Coverage o Added language for plan years that begin on or after Sept. 23, 2010 to indicate: . For most benefit plans, prior authorization requirements apply to BRCA lab screening . For medical necessity benefit plans, genetic counseling from an Independent Genetics Provider (see Definitions section of policy) is required before

UnitedHealthcare will approve prior authorization

requests (effective Jan. 1, 2016)

Related Services o Revised language pertaining to preventive colonoscopy to indicate: . All services for a preventive colonoscopy (e.g., associated

85 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jan. 1, 2016 facility, anesthesia, Services pathologist, and physician (continued) fees) . The preventive benefit does not include a post-operative examination . Effective Jan. 1, 2016, the preventive benefit includes a pre-operative examination/consultation prior to a preventive colonoscopy  Updated definitions; added definition of “independent genetics provider (for medical necessity benefit plans)”  Revised list of applicable procedure and diagnosis codes: Preventive Care Services Genetic Counseling and Evaluation for BRCA Testing; and BRCA Lab Screening o Updated list of applicable CPT codes for BRCA Lab Screening to reflect annual code edits (effective Jan. 1, 2016); added 81162 o Revised claims edit criteria for Genetic Counseling and Evaluation; added language to indicate Medical Necessity plans require genetic counseling before BRCA Lab Screening Colorectal Cancer Screening o Updated lists of applicable codes for Fecal Occult Blood Testing (FOBT), Sigmoidoscopy, or Colonoscopy; added Code Group 5:

86 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jan. 1, 2016 . CPT codes: 99201, 99202, Services 99203, 99204, 99205, (continued) 99211, 99212, 99213, 99214, 99215, 99241, 99242, 99243, 99244, and 99245 . ICD-10 diagnosis codes: Z12.10, Z12.11, Z12.12, Z80.0, Z83.71, and Z83.79 o Revised claims edit criteria for Fecal Occult Blood Testing, Sigmoidoscopy, or Colonoscopy to indicate as of 1/1/16, Code Group 5 is paid as Preventive if billed with one of the Code Group 5 diagnosis codes Behavioral Counseling in Primary Care to Promote a Healthful Diet and Physical Activity for Cardiovascular Disease Prevention in Adults with Cardiovascular Risk Factors o Updated list of applicable CPT codes for Behavioral Counseling or Therapy to reflect annual code edits (effective Jan. 1, 2016); added 0403T o Revised claims edit criteria; added language to indicate a listed diagnosis code is required for CPT code 0403T Tobacco Smoking Cessation in Adults, including Pregnant Women: Behavioral and Pharmacotherapy Interventions o Updated service title/heading; previously titled Counseling and Interventions to Prevent Tobacco Use and Tobacco-

87 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jan. 1, 2016 Caused Disease in Adults and Services Pregnant Women Counseling (continued) and Interventions (Adults) o Revised service description: . Removed April 2009 USPSTF ‘A’ rating . Added September 2015 USPSTF ‘A’ rating: - The USPSTF recommends that clinicians ask all pregnant women about tobacco use, advise them to stop using tobacco, and provide behavioral interventions for cessation to pregnant women who use tobacco - The USPSTF recommends that clinicians ask all adults about tobacco use, advise them to stop using tobacco, and provide behavioral interventions and U.S. Food and Drug Administration (FDA)– approved pharmacotherapy for cessation to adults who use tobacco o Reformatted list of applicable procedure codes; added heading titled Behavioral Interventions Screening for Visual Impairment in Children o Updated list of applicable CPT codes to reflect annual code edits (effective Jan. 1, 2016); added 99177

88 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jan. 1, 2016 o Added claims edit criteria for Services CPT code 99177 to indicate: (continued) . A benefit age limit of “less than age 6 years (ends on 6th birthday)” applies . Refer to the Medical Policy titled Omnibus Codes for allowable diagnoses TB Testing (Bright Futures) o Updated claims edit criteria; added language to clarify CPT code 99211 is only payable as preventive with ICD-10 diagnosis codes R76.11, R76.12, and Z11.1 Preventive Immunizations o Updated list of applicable CPT/HCPCS codes to reflect annual code edits (effective Jan. 1, 2016): . Haemophilus influenza b (Hib): Removed 90645 and 90646 . Human Papilloma Virus (HPV): Revised description for 90651 . Pneumococcal conjugate: Removed 90669 and S0195 . Tetanus: Removed 90703 . Measles, Mumps, Rubella (MMR): Removed 90704, 90705, 90706, 90707 and 90708 . Diphtheria: Removed 90719, 90720 and 90721 o Revised claims edit criteria for seasonal influenza (‘flu’); changed benefit age limit for CPT code 90673 to “age 18

89 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jan. 1, 2016 years and up” Services o Updated list of applicable trade (continued) names for CPT code 90696 (diphtheria, tetanus toxoids, acellular pertussis vaccine and inactivated poliovirus vaccine); added Quadracel® Diabetes Diagnosis Code List o Corrected formatting error in list applicable ICD-10 diagnosis codes; changed service heading/classification for E10.630, E10.638, E10.641, E10.649, E10.65, E10.69, E10.8, E10.9 from “Type 2 Diabetes Mellitus ” to “Type 1 Diabetes Mellitus” Expanded Women’s Preventive Health Contraceptive Methods (Including Sterilizations) o Replaced notation indicating “certain health plans sponsored by religious employers may qualify for an exemption from covering contraceptive methods and sterilizations” with “certain employers may qualify for an exemption from covering contraceptive methods and sterilizations on account of religious objections” o Revised list of applicable HCPCS codes for contraceptive methods/intrauterine devices (IUDs) to reflect annual code edits (effective Jan. 1, 2016): . Updated Code Group 1 for IUD (other):

90 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Preventive Care Jan. 1, 2016 - Added J7297 Services . Updated Code Group 2 for (continued) IUDs: - Added J7298 - Removed J7302 Proton Pump Jan. 1, 2016  Revised coverage rationale; Certain proton pump inhibitors (PPIs) are excluded from coverage due to Inhibitors removed “Esomeprazole the availability of over-the-counter (OTC) therapeutically equivalent Strontium” from list of proton medications. This is subject to medical necessity review as outlined below. pump inhibitors generally excluded Note: This policy does not apply to the excluded plans and products noted from coverage above.

The following proton pump inhibitors (PPIs) will be covered without precertification:  Dexilant (brand)  Omeprazole (generic)  Pantoprazole (generic)  Rabeprazole (generic)

The following proton pump inhibitors (PPIs) are generally excluded from coverage but may be covered for Members who meet the associated criteria:  AcipHex (brand)  AcipHex Sprinkle  Prilosec Suspension  Protonix (brand)  Protonix Granules for Suspension  Vimovo

Criteria  Clinical office notes document that the Member has tried and failed all of the following medications: Dexilant, omeprazole (generic), pantoprazole (generic), rabeprazole (generic); and  Provider has submitted article(s) published in the peer-reviewed medical literature showing that the prescribed drug is likely to be more beneficial to the Member than the covered formulary drugs and over-the-counter (OTC) therapeutic equivalents.

For coverage guidelines for Nexium suspension and Prevacid SoluTab, refer to: Drug Coverage Guidelines.

91 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Remicade Dec. 1, 2015  Revised coverage rationale: Remicade (infliximab) is proven and medically necessary for the (Infliximab) o Modified coverage criteria for treatment of:

treatment of ankylosing 1. Ankylosing spondylitis when the following criterion is met spondylitis, Crohn’s disease, A. Diagnosis of ankylosing spondylitis (AS) plaque psoriasis, psoriatic 2. Crohn’s disease when the following criterion is met: arthritis, rheumatoid A. One of the following: arthritis and ulcerative 1. Diagnosis of fistulizing Crohn’s disease (Crohn’s Disease Activity colitis; removed criterion Index (CDAI) ≥ 220 and ≤ 400), or requiring: 2. Both of the following: . Remicade is initiated and a. Diagnosis of moderately to severely active adult or pediatric titrated according to US Food Crohn’s disease; and and Drug Administration b. History of failure, contraindication, or intolerance to at least labeled dosing one conventional therapy (e.g., corticosteroids, 6- . Remicade is not received for mercaptopurine, azathioprine, methotrexate, etc.) use in combination with

other biologic DMARDs or 3. Noninfectious uveitis when both of the following criteria are met: janus kinase inhibitors A. Diagnosis of refractory noninfectious uveitis that is causing or

o Modified coverage criteria for threatening vision loss (e.g., noninfectious uveitis associated with treatment of sarcoidosis; Behçet’s or Reiter’s syndromes); and

removed criterion requiring: B. History of failure, contraindication, or intolerance to all of the . Remicade is not received for following: use in combination with 1. Topical corticosteroids other biologic DMARDs or 2. Systemic corticosteroids janus kinase inhibitors 3. Immunosuppressive drugs (e.g., azathioprine, cyclosporine, or methotrexate)

4. Plaque psoriasis when both of the following criteria are met: A. Diagnosis of chronic severe plaque psoriasis i.e., extensive and/or disabling); and B. Patient is a candidate for systemic therapy

5. Psoriatic arthritis when the following criterion is met A. Diagnosis of psoriatic arthritis (PsA);

6. Rheumatoid arthritis when both of the following criteria are met: A. Diagnosis of moderately to severely active rheumatoid arthritis (RA); and B. One of the following: 1. Member is receiving concurrent therapy with methotrexate 2. History of contraindication or intolerance to methotrexate

92 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Remicade Dec. 1, 2015 7. Sarcoidosis when all of the following criteria are met: (infliximab) A. Diagnosis of sarcoidosis; and (continued) B. History of failure, contraindication, or intolerance to corticosteroids (e.g., prednisone, methylprednisolone); and C. History of failure, contraindication, or intolerance to one immunosuppressant (e.g., methotrexate, cyclophosphamide, azathioprine);

8. Ulcerative colitis when both of the following criteria are met: A. Diagnosis of moderately to severely active adult or pediatric ulcerative colitis (UC); and B. History of failure, contraindication, or intolerance to at least one conventional therapy e.g., 6-mercaptopurine, aminosalicylate, azathioprine, corticosteroids

There may be other conditions that qualify as serious, rare diseases for

which the use of Remicade may be appropriate. Please refer to the Benefit

Considerations section of this policy for additional information.

Remicade is unproven and not medically necessary in the treatment

of:

 Adult-onset Still's disease

 Sjogren's syndrome

 Graft-vs-host disease

 Myelodysplastic syndromes

 Undifferentiated spondyloarthropathy

 Reiter's syndrome

 Hidradenitis suppurativa

 Wegener's granulomatosis

 Juvenile idiopathic arthritis (juvenile rheumatoid arthritis)

Remicade is unproven and not medically necessary for the

treatment of the above conditions because statistically robust

randomized controlled trials are needed to address the issue of whether

Remicade has sufficient superiority in clinical efficacy compared to other

available treatments to justify the inherent clinical risk in the use of a

monoclonal antibody anti-tumor necrosis factor agent.

Sandostatin Lar Jan. 1, 2016  Updated benefit considerations; Please refer to Injectable Chemotherapy Drugs: Application of NCCN Clinical Depot (Octreotide added language for Essential Practice Guidelines, for updated information based on the National Acetate) Health Benefits for Individual and Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium for

93 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Sandostatin Lar Jan. 1, 2016 Small Group plans to indicate: oncology indications. Depot (Octreotide o For plan years beginning on or Acetate) after January 1, 2014, the Note: For information regarding coverage for Sandostatin® (continued) Affordable Care Act of 2010 subcutaneous formulation, refer to: Drug Coverage Guidelines. (ACA) requires fully insured non-grandfathered individual 1. Sandostatin LAR is proven and medically necessary in the and small group plans (inside treatment of acromegaly when all of the following criteria are and outside of Exchanges) to met: provide coverage for ten A. Diagnosis of acromegaly by one of the following: categories of Essential Health 1) Serum GH level > 1 ng/mL after a 2 hour oral glucose tolerance Benefits (“EHBs”) test (OGTT) at time of diagnosis; or o Large group plans (both self- 2) Elevated serum IGF-1 levels (above the age and gender adjusted funded and fully insured), and normal range as provided by the physician’s lab) at time of small group ASO plans, are not diagnosis; subject to the requirement to and offer coverage for EHBs; B. One of the following: however, if such plans choose 1) Inadequate response to one of the following: to provide coverage for benefits a) Surgery which are deemed EHBs (such b) Radiotherapy as maternity benefits), the ACA c) Dopamine agonist (e.g., bromocriptine, cabergoline) therapy requires all dollar limits on or those benefits to be removed 2) Not a candidate for any of the following: on all Grandfathered and Non- a) Surgery Grandfathered plans b) Radiotherapy o The determination of which c) Dopamine agonist (e.g., bromocriptine, cabergoline) therapy benefits constitute EHBs is and made on a state by state basis; C. Initial treatment with octreotide immediate release (IR) has been as such, when using this shown to be effective and tolerated guideline, it is important to 2. Sandostatin LAR is proven and medically necessary in the refer to the member specific treatment of bleeding gastroesophageal varices associated with benefit document to determine liver disease benefit coverage  Updated coverage rationale: Additional information to support medical necessity review: o Reorganized clinical criteria to Octreotide acetate is medically necessary for the treatment of bleeding improve clarity esophageal varices when both of the following criteria are met:

o Replaced references to A. Diagnosis of bleeding esophageal varices associated with liver “octreotide acetate” with disease; and “Sandostatin” B. Octreotide acetate will be used as an adjunct to endoscopic therapy  Updated supporting information to

94 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Sandostatin Lar Jan. 1, 2016 reflect the most current clinical 3. Sandostatin LAR is proven and medically necessary in the Depot (Octreotide evidence, FDA information and treatment of chemotherapy and/or radiation-induced diarrhea Acetate) references 4. Sandostatin LAR is proven and medically necessary in the (continued) treatment of malignant bowel obstruction

5. Sandostatin LAR is proven and medically necessary in the treatment of refractory HIV/AIDS-related diarrhea

Additional information to support medical necessity review: Octreotide acetate is medically necessary for the treatment of refractory HIV/AIDS-related diarrhea when both of the following criteria are met:

A. Diagnosis of HIV/AIDS-related diarrhea; and B. History of failure, contraindication, or intolerance to standard therapy (e.g., loperamide, diphenoxylate/atropine)

Sandostatin LAR is unproven and not medically necessary for treating the following conditions: 1. chylothorax 2. dumping syndrome 3. pancreatitis 4. persistent hyperinsulinemic hypoglycemia of infancy 5. prevention of postoperative complications following pancreatic surgery 6. short bowel syndrome

Sandostatin LAR is unproven and not medically necessary for treating other conditions not listed above as proven and medically necessary due to the lack of published clinical evidence of safety and/or efficacy in published peer reviewed medical literature.

Documentation required for Medical Director Review: Letter of medical necessity and/or office notes. Specialty Jan. 1, 2016  Revised coverage rationale: Introduction

Medication o Modified introduction language This policy addresses the criteria for consideration of allowing hospital Administration - to indicate this policy addresses outpatient facility specialty medication infusion services. This includes claim Site of Care Review the criteria for consideration of submission for hospital based services with the following CMS/AMA Place of Guidelines allowing hospital outpatient Service codes: facility specialty medication  22 On Campus - Outpatient Hospital; and infusion services; this includes  19 Off Campus - Outpatient Hospital claim submission for hospital

95 Oxford® Policy Update Bulletin: December 2015 Oxford

Clinical Policy Updates

REVISED Policy Title Effective Date Summary of Changes Coverage Rationale Specialty Jan. 1, 2016 based services with the Alternative sites of care, such as non-hospital outpatient infusion, physician Medication following CMS/AMA Place of office, ambulatory infusion or home infusion services are well accepted Administration - Service codes: places of service for medication infusion therapy. If a patient does not meet Site of Care Review . 22 On Campus - Outpatient criteria to for outpatient hospital facility infusion, alternative sites of care Guidelines Hospital; and may be used. (continued) . 19 Off Campus - Outpatient Hospital This policy applies to these specialty medications that require healthcare o Modified content sub- provider administration: header/title; changed “Medical  Abatacept (Orencia®) Necessity Criteria for Site of  Eculizumab (Soliris®) Care Selection” to “Review  Infliximab (Remicade® lyophilized concentrate for intravenous use) Criteria for Site of Care  Tocilizumab (Actemra® injection for intravenous use) Selection”  Vedolizumab (Entyvio®)

Review Criteria for Site of Care Selection

Outpatient hospital facility-based intravenous medication infusion is medically necessary for Members who meet any of the following criteria:  Medically unstable based upon submitted clinical history; or  Initial medication infusion of or re-initiation after more than 6 months following discontinuation of therapy; or  Previous experience of a severe adverse event following infusion. Examples include but are not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure; or  Continuing experience of adverse events that cannot be mitigated by pre-medications; or  Physically and/or cognitively impaired and no home caregiver available.

Additional Information: Medical necessity criteria for administration of intravenous infusion therapy at home are addressed in MCG™ Care Guidelines, 19th edition, 2015, Home Infusion Therapy, CMT: CMT- 0009(SR).

96 Oxford® Policy Update Bulletin: December 2015 Oxford

Administrative Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Administrative Guidelines Orthopedic Jan. 1, 2016  Updated list of applicable ICD-10 Oxford covers medically necessary acute care services and post-acute Services diagnosis codes; removed R68.89 services delivered at the most appropriate level of care. OrthoNet's orthopedic division will perform utilization management to review requested services that should meet approved clinical guidelines for medical necessity. Review is conducted by determining medical necessity and medical appropriateness, and to initiate discharge planning as appropriate. The review will be based on the obtained clinical information and some or all of the following criteria/tools:  Member benefits  Oxford medical and reimbursement policies  MCG™ Care Guidelines, 19th edition, 2015 (Inpatient Care)

Services performed by the following specialists (participating/non- participating), regardless of diagnosis, are subject to utilization review with OrthoNet’s orthopedic division.  Hand Surgeon  Neurosurgeon  Orthopedic Surgeon  Pediatric Orthopedic Surgeon  Physical Medicine and Rehabilitation  Podiatrist

and

Services rendered by the below facilities (participating/non-participating), when billed in conjunction with certain identified ICD-9 codes (see the Applicable Codes section of the policy for a list of ICD-9 codes) are subject to utilization review with OrthoNet’s orthopedic division.  Acute Care Hospital  Ambulatory Surgery Center  Durable Medical Equipment  Home Health Care  Physical Rehabilitation Hospital  Physical Rehabilitation Facility  Skilled Nursing Facility  Other Ancillary

Medical Director Review Requirements

If a request is submitted which:

97 Oxford® Policy Update Bulletin: December 2015 Oxford

Administrative Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Administrative Guidelines Orthopedic Jan. 1, 2016  Meets the applicable guideline(s)/medical criteria, an Orthonet Services Case Manager may make a utilization review decision (with oversight by a (continued) Medical Director).  Does not meet the applicable guideline(s)/criteria, and/or there is a question regarding whether the request is a covered benefit, the request will be referred to an OrthoNet Medical Director for review and decision- making.

Additional information as well as input from a consultant may be requested and reviewed as part of this process.

In the case of non-certification decisions, where the Orthonet Case Manager did not make an attempt to discuss the matter with the Member’s provider, a reconsideration procedure will be offered and activated according to current regulatory requirements and Oxford policy.

A Medical Director must make all adverse utilization review decisions including those for benefit non-certifications (with the exception of non- certification due to the member's enrollment status with Oxford and approval determinations).

Note:  Home health and skilled nursing facility (SNF) benefits will be coordinated between Oxford and OrthoNet Global Orthopedics.  Pre-Existing Conditions: Individuals of any age cannot be denied coverage, charged higher premiums, subjected to an extended waiting period or have benefits modified because of a preexisting condition.  Payment for requested services will be based on Oxford medical and reimbursement policies. Precertification Jan. 1, 2016  Revised list of CPT/HCPCS codes Refer to the policy for complete details on Precertification Exemptions for Exemptions for that do not require Outpatient Services. Outpatient Services precertification in the office or outpatient setting: o Radiology - Diagnostic Imaging: . Removed 72010 and 73500 (deleted codes effective Jan.1, 2016)

98 Oxford® Policy Update Bulletin: December 2015 Oxford

Administrative Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Administrative Guidelines Precertification Jan. 1, 2016 o Pathology and Laboratory: Exemptions for . Updated applicable code Outpatient Services ranges to reflect/include (continued) 80047-81050, 81200- 81210, 81217, 81221- 81228, 81161*, 81235- 81408, 81410-81417, 81425-81431, 81460- 81471, 81500-81506, 81508-81519, 82009- 82668, 82671-82985, 83003-83987, 84030- 84830, 85002-85810, 86000-86835, 86850- 86985, 87003-87880, 87905, 88104-88189, 88230-88271, 88273- 88388, 88720-88741 and 89049-89230 *Note: Code is out of sequence in CPT o Immunizations, Vaccines, and Toxoids: . Removed 90669 and 90719 (deleted codes effective Jan.1, 2016) . Updated applicable code ranges to reflect/include 90460-90461, 90471- 90477, 90585-90654, 90630*, 90655-90660, 90672*, 90661, 90673*, 90662-90688, 90696- 90716, 90720-90723, 90732-90734, 90736, 90739-90748 and G0008- G0010 *Note: Code is out of sequence in CPT

99 Oxford® Policy Update Bulletin: December 2015 Oxford

Administrative Policy Updates

UPDATED Policy Title Effective Date Summary of Changes Administrative Guidelines Precertification Jan. 1, 2016 o Behavioral Health Services: Exemptions for . Updated applicable code Outpatient Services ranges to reflect/include (continued) 90785, 90791-90792, 90832-90838, 90839- 90840, 90845-90849, 90853, 90863, 90865 and 90875-90876 . Updated language detailing “special considerations” to indicate: - Refer to the policy titled Behavioral Health Services for additional information - Intensive Outpatient Therapy (IOP) & Partial Hospitalization (PHP) require precertification o Special Otorhinolaryngologic Services: . Updated applicable code ranges to reflect/include 92508, 92526, 92601- 92604, 92610 and 92626- 92633 o Neurology and Neuromuscular Procedures: . Updated applicable code ranges to reflect/include 95822, 95829, 95860- 95864, 95867-95872, 95921-95922, 95925- 95926, 95927, 95930- 95937, 95955 and 95961- 95962

100 Oxford® Policy Update Bulletin: December 2015 Oxford

Administrative Policy Updates

REVISED Policy Title Effective Date Summary of Changes Administrative Guidelines Site of Service Jan. 1, 2016  Revised reimbursement Place of Service Codes:

Differential guidelines; updated list of facility If a provider performs one of the eligible procedures in a setting with one of setting/place of service (POS) these place codes, the provider will be reimbursed at the Site of Service codes: differential rate. For place codes outside of this list, the provider will be o Added POS code 19: Off reimbursed at the non-facility fee. Campus - Outpatient Hospital Place Code Description (new code effective Jan. 1, 5 Indian Health Service Free Standing Facility 2016) 6 Indian Health Service Provider-based Facility o Revised description for POS code 22: On Campus - 7 Tribal 638 Free-standing Facility Outpatient Hospital 8 Tribal 638 Provider-based Facility 19 Off Campus-Outpatient Hospital 21 Inpatient Hospital 22 On Campus-Outpatient Hospital 23 Emergency Room Hospital 24 Ambulatory Surgical Center 26 Military Treatment Facility 31 Skilled Nursing Facility 34 Hospice 41 Ambulance - Land 42 Ambulance - Air or Water 51 Inpatient Psychiatric Facility 52 Psychiatric Facility Partial Hospitalization 53 Community Mental Health Center 56 Psychiatric Residential Treatment Center 61 Comprehensive Inpatient Rehabilitation Facility

For a list of applicable CPT/HCPCS codes, refer to Procedures Eligible for a Site of Service Differential.

101 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

NEW Policy Title Effective Date Reimbursement Guidelines Physical Medicine & Mar. 1, 2016 Reimbursement Rehabilitation: Consistent with CMS, Oxford ranks all reimbursable procedures from the Multiple Therapy Reducible Codes list Multiple Therapy (procedures with indicator 5 in the Multiple Procedure Payment Reduction [MPPR] field on the CMS National Physician Procedure Fee Schedule) that are provided on a single date of service. The primary procedure is reimbursed without reduction Reduction and the PE portions of all secondary and subsequent procedures from this list performed by the Same Group Physician and/or Other Health Care Professional on the same date are reduced by 50%.

The multiple therapy procedure reduction applies when more than one procedure, or more than one unit of the same procedure, from the Multiple Therapy Reducible Codes list is provided to the same patient on the same day, i.e., the reduction applies to multiple units as well as to multiple procedures.

These reductions apply to the Same Group Physician and/or Other Health Care Professional, regardless of specialty. These reductions do not apply to flat rate per diem contract providers.

Procedure Ranking

The CMS Non-Facility PE RVU assigned to each code on the Multiple Therapy Reducible Codes list is used to

determine the primary procedure. The primary procedure is identified as the procedure having the highest PE RVU

on a given date of service. The PE portion of the charge for the primary procedure will not be reduced.

For the remaining Multiple Therapy Reducible Codes reported on the same date of service by the Same Group Physician and/or Other Health Care Professional, an amount representing the PE for each code will be reduced by 50%. The PE amount is determined by calculating the ratio of CMS PE RVU to Total RVU assigned to each secondary and subsequent procedure on the same date of service. When procedures share the same PE RVU, the Total RVU is used to further rank those codes.

Example The following table shows an example of how reimbursement is determined for services subject to this policy when services are furnished to a patient on a single date of service by the Same Group Physicians and/or Other Health Care Professionals.

Portion of charge Allowable attributable Amount PE Total Final Allowable Code to Practice Ranking Comments Prior to RVU RVU Amount Expense Reduction (PE RVU/ Total RVU) Multiple $31.60 .45 .79 56% 3 PE value = 56% of Therapy $31.60 or $17.70. Reducible Code $17.70 is reduced by A 50% or $8.85. Allowable Amount =

102 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

NEW Policy Title Effective Date Reimbursement Guidelines Physical Medicine & Mar. 1, 2016 $31.60 - $8.85 or Rehabilitation: $22.75. Multiple Therapy Multiple $40.40 .36 1.01 35% 4 PE value = 35% of Procedure Therapy $40.40 or $14.14. Reducible Code $14.14 is reduced by Reduction B 50% or $7.07. (continued) Allowable Amount = $40.40 - $7.07 or $33.33.

Multiple $36.40 .45 .91 49% 2 Because Codes A PE value = 49% of Therapy and C have the $36.40 or $17.84. Reducible Code same PE RVUs, $17.84 is reduced by C the Total RVUs 50% or $8.92. are used to Allowable Amount = further rank $36.40 - $8.92 or these two $27.48. procedures. Multiple $96.80 1.05 2.42 43% 1 Primary $96.80 Therapy procedure Reducible Code (highest PE D value) is not subject to reduction

\

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Injection and Jan. 1, 2016  Revised reimbursement Injections (96372-96379) and Evaluation and Management Services Infusion Services guidelines; updated list of facility by Place of Service

setting/place of service (POS) Facility, Emergency Room, and Ambulatory Surgical Center Services: codes: Per CPT and the CMS National Correct Coding Initiative (NCCI) Policy Manual, o Added POS code 19: Off CPT codes 96372-96379 are not intended to be reported by the physician in Campus - Outpatient Hospital the facility setting. Thus, when an E/M service and a therapeutic and (new code effective Jan. 1, diagnostic injection service are submitted with CMS Place of Service (POS) 2016) codes 19, 21, 22, 23, 24, 26, 51, 52, and 61 for the same patient by the o Revised description for POS Same Individual Physician or Other Health Care Professional on the same code 22: On Campus - date of service, only the E/M service will be reimbursed and the therapeutic Outpatient Hospital and diagnostic Injection(s) are not separately reimbursed, regardless of whether a modifier is reported with the injection(s).

103 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Injection and Jan. 1, 2016 Non-Facility Injection Services: Infusion Services E/M services provided in a non-facility setting are considered an inherent (continued) component for providing an injection service. CPT indicates these services typically require direct supervision for any or all purposes of patient assessment, provision of consent, safety oversight, and intra-service supervision of staff. When a diagnostic and therapeutic Injection procedure is performed in a POS other than 19, 21, 22, 23, 24, 26, 51, 52, and 61 and an E/M service is provided on the same date of service, by the Same Individual Physician or Other Health Care Professional only the appropriate therapeutic and diagnostic injection(s) will be reimbursed and the EM service is not separately reimbursed.

If a significant, separately identifiable EM service is performed unrelated to the physician work (injection preparation and disposal, patient assessment, provision of consent, safety oversight, supervision of staff, etc.) required for the injection service, modifier 25 may be reported for the E/M service in addition to 96372-96379. If the E/M service does not meet the requirement for a significant separately identifiable service, then modifier 25 would not be reported and a separate E/M service would not be reimbursed.

Exceptions CPT 99211: E/M service code 99211 will not be reimbursed when submitted with a diagnostic or therapeutic Injection code, with or without modifier 25. This very low service level code does not meet the requirement for "significant" as defined by CPT, and therefore should not be submitted in addition to the procedure code for the injection.

CPT 99381-99429: The Preventive Medicine codes (99381-99429) do not need modifier 25 to indicate a significant, separately identifiable service when reported in addition to the diagnostic and therapeutic injection service. The Preventive Medicine codes include routine services such as the ordering of immunizations or diagnostic procedures. The performance of these services is to be reported in addition to the Preventive Medicine E/M code. Therefore, diagnostic and therapeutic Injections can be reported at the same time as a Preventive Medicine code without appending modifier 25.

CMS POS Database

E&M Codes for Injection Codes 96372-96379

104 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Injection and Jan. 1, 2016 Injection and Infusion Services (96360-96549) and HCPCS Supplies Infusion Services Consistent with CPT guidelines, HCPCS codes identified by code description (continued) as standard tubing, syringes, and supplies are considered included when reported with Injection and Infusion services, CPT codes 96360-96549, and will not be separately reimbursed.

Injection and Infusion Inclusive Supplies

Note: Additional editing may be applicable to CPT codes 96360-96549 under the T Status Codes Policy.

Drug Codes Oxford reimbursement policy is aligned with CMS and will separately reimburse for the HCPCS drug code when submitted with Injection or Infusion codes (CPT 96360-96549) by the Same Individual Physician or Other Health Care Professional on the same date of service under the guidelines of this policy. Maximum Jan. 1, 2016  Revised Maximum Frequency Per MFD Determination: Part I Frequency Per Day Day Code List (attachment file The following criteria are first used to determine the MFD values for codes to detailing maximum frequency per which these criteria are applicable: day value assignments for CPT  The service is classified as bilateral (CMS Indicators 1 or 3) on the and HCPCS codes); updated Centers for Medicare & Medicaid Services (CMS) National Physician Fee maximum frequency per day Schedule (NPFS) or the term 'bilateral' is included in the code descriptor. value assignments for 81266, For the majority of these codes, the MFD value is 1. There are some 83664, 88177, A4256, A4310, codes that describe more than one anatomical site or vertebral level that A4311, A4312, A4313, A4315, can be treated bilaterally where the MFD value may be more than 1. A4316, A4331, A4334, A4338,  Where the CPT or HCPCS code description/verbiage references reporting A4340, A4344, A4346, A4354, the code once per day, the MFD value is 1. A4357, A4358, A4361, A4363,  The service is anatomically or clinically limited with regard to the number A4367, A4384, A5082, A5105, of times it may be performed, in which case the MFD value is established A5112, A5113, A5114, A5131, at that value. A7001, A7004, A7007, A7012,  The CPT or HCPCS code description/verbiage indicates the number of A7015, A7032, A7033, A7038, times the service can be performed, in which case the MFD value is set at A7525, A9572, B4081, B4082, that value. B5100, J0153, J0598, J0637,  CMS Durable Medical Equipment Medicare Administrative Contractor J0640, J1071, J1267, J1300, (DMEMAC) Local Coverage Determination (LCD) assigns an MFD value in J1335, J1380, J1439, J1453, which case the MFD value is set at that value. J1743, J1817, J1931, J2020,  Where the criteria above have not defined an MFD value, the CMS

105 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Jan. 1, 2016 J2248, J2280, J2469, J2543, Medically Unlikely Edits (MUE) value, where available, will be utilized to Frequency Per Day J2680, J2785, J2794, J2796, establish an MFD value. (continued) J2997, J3101, J3121, J3240,  Where no other definitive value has been established based on the J3243, J3246, J3262, J3300, criteria above, drug HCPCS codes will have an MFD value of 999 which J3301, J3357, J3360, J3370, indicates they are exempt from the MFD policy. J3396, J3420, J3430, J7311,  Where no other definitive value has been established based on the J7327, J7511, J9025, J9031, criteria above, unlisted CPT and HCPCS codes will have an MFD value of J9033, J9043, J9045, J9055, 999 which indicates they are exempt from the MFD policy. J9060, J9065, J9171, J9190,  Where no other definitive value has been established based on the J9206, J9217, J9261, J9266, criteria above, new CPT codes released by the American Medical J9267, J9268, J9280, J9293, Association and new HCPCS codes released by CMS since the last MFD J9301, J9303, J9305, J9307, value update (not covered by any of the above criteria), will have an MFD J9315, J9320, J9370, J9390, value of 100. J9395, K0604, Q4120, Q4139, Q9953, Q9957, Q9958, Q9961, MFD Determination: Part II

Q9963, Q9966 and Q9967 When none of the criteria listed in Part I apply to a code, data analysis is conducted to establish MFD values according to common billing patterns.  When a code has 50 or more claim occurrences in a data set, the MFD values are determined through claim data analysis and are set at the 100th percentile (i.e. the highest number of units billed for that CPT or HCPCS code in the data set). If the 100th percentile exceeds the 98th percentile by a factor of four, the MFD will be set at the 98th percentile.  When a code has less than 50 claim occurrences in a data set, the MFD values will be set at the default of 100 until the next annual analysis.  In any case where, in Oxford's judgment, the 98th percentile does not account for the clinical circumstances of the services billed, the MFD for a code may be increased so as to capture only obvious billing submission and data entry errors.

The "MFD per Day Policy List" list below contains the most current MFD values.

 Maximum Frequency Per Day List Reimbursement

The MFD values apply whether a physician, hospital, ambulatory surgical

center, or other health care professional submits one CPT or HCPCS code

with multiple units on a single claim line or multiple claim lines with one or

more unit(s) on each line. It is common coding practice for some CPT and

106 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Jan. 1, 2016 HCPCS codes to be submitted with multiple units. However, when reporting Frequency Per Day the same CPT or HCPCS code on multiple and/or separate claim lines, the (continued) claim line may be classified as a duplicate service and/or may be subject to additional Oxford reimbursement policies.

Services provided are reimbursable services up to and including the MFD value for an individual CPT or HCPCS code. In some instances, a modifier may be necessary for correct coding and corresponding reimbursement purposes.

Bilateral payment via the use of modifiers LT or RT is inappropriate for procedures, services, and supplies where the concept of laterality does not apply. Oxford will pay up to the maximum frequency per day value for codes with "bilateral" or "unilateral or bilateral" in description or for codes where the concept of laterality does not apply, whether submitted with or without modifiers LT and/or RT by the same individual physician, hospital, ambulatory surgical center, or other healthcare professional on the same date of service for the same member. Use of modifiers LT and/or RT on the codes identified in the "Codes Restricting Modifiers LT and RT" list will be considered informational only.

 Codes Restricting Modifiers LT and RT

There may be situations where a physician, hospital, ambulatory surgical center, or other healthcare professional reports units accurately and those units exceed the established MFD value. In such cases, Oxford will consider additional reimbursement if reported with an appropriate modifier such as modifier 59, 76, 91, XE, XS or XU. Medical records are not required to be submitted with the claim when modifiers 59, 76, 91, XE, XS or XU are appropriately reported. Documentation within the medical record should reflect the number of units being reported and should support the use of the modifier.

Modifiers

Modifier Modifier Description Distinct Procedural Service Under certain circumstances, it may be necessary to indicate 59 that a procedure or service was distinct or independent from other non-E/M services performed on the same day. Modifier

107 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Jan. 1, 2016 59 is used to identify procedures or services, other than E/M Frequency Per Day services, that are not normally reported together but are (continued) appropriate under the circumstances. Documentation must support a different session, different procedure or surgery, different size or organ system, separate incision or excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. However, when another already established modifier is appropriate it should be used rather than modifier 59. Only if no more descriptive modifier is available and the use of modifier 59 best explains the circumstances should modifier 59 be used. Note: Modifier 59 should not be appended to an E/M service. To report a separate and distinct E/M service performed on the same date, see modifier 25. Repeat Procedure or Service by Same Physician or Other Qualified Health Care Professional It may be necessary to indicate that a procedure or service was repeated subsequent to the original procedure or service. This circumstance may be reported by adding modifier 76 to the repeated procedure or service. Note: This modifier should not be appended to an E/M service. 76 To report a separate and distinct E/M service performed on the same date, see modifier 25. It is also inappropriate to use modifier 76 to indicate repeat laboratory services. Modifiers 59 or 91 should be used to indicate repeat or distinct laboratory services, as appropriate according to the AMA and CMS. Separate consideration for reimbursement will not be given to laboratory codes reported with modifier 76. Repeat Clinical Diagnostic Laboratory Test In the course of treatment of the patient, it may be necessary to repeat the same laboratory test on the same day to obtain subsequent (multiple) test results. Under these circumstances, 91 the laboratory test performed can be identified by its usual procedure number and the addition of modifier 91. Note: This modifier may not be used when tests are rerun to confirm initial results; due to testing problems with specimens or equipment; or for any other reason when a normal, one-time, reportable

108 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Jan. 1, 2016 result is all that is required. This modifier may not be used Frequency Per Day when other code(s) describe a series of test results (eg, glucose (continued) tolerance tests, evocative/suppression testing). This modifier may only be used for laboratory test(s) performed more than once on the same day on the same patient. Separate Encounter XE A service that is distinct because it occurred during a separate encounter. Separate Structure XS A service that is distinct because it was performed on a separate organ/structure. Unusual Non-Overlapping Service XU The use of a service that is distinct because it does not overlap usual components of the main service.

Anatomic Modifiers

Modifie Modifier Description r E1 Upper left eyelid E2 Lower left eyelid E3 Upper right eyelid E4 Lower right eyelid F1 Left hand, second digit F2 Left hand, third digit F3 Left hand, fourth digit F4 Left hand, fifth digit F5 Right hand, thumb F6 Right hand, second digit F7 Right hand, third digit F8 Right hand, fourth digit

F9 Right hand, fifth digit

FA Left hand, thumb

LC Left circumflex coronary artery

LD Left anterior descending coronary artery

LM Left main coronary artery LT Left side RC Right coronary artery

109 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Maximum Jan. 1, 2016 RI Ramus intermedius coronary artery Frequency Per Day RT Right side (continued) T1 Left foot, second digit T2 Left foot, third digit T3 Left foot, fourth digit T4 Left foot, fifth digit T5 Right foot, great toe T6 Right foot, second digit T7 Right foot, third digit T8 Right foot, fourth digit T9 Right foot, fifth digit TA Left foot, great toe

Moderate Sedation Jan. 1, 2016  Revised reimbursement Attending Physician (99143-99145) guidelines; updated list of facility Oxford will allow separate reimbursement for Moderate Sedation services setting/place of service (POS) reported as CPT codes 99143-99145 when provided by the Same Physician, codes: hospital, ambulatory surgical center, or other qualified health care o Added POS code 19: Off professional reporting the diagnostic or therapeutic procedure except when Campus - Outpatient Hospital reported with:

(new code effective Jan. 1, 1. Procedures listed in Appendix G of the CPT book 2016) 2. Anesthesia procedures (CPT codes 00100-01999) o Revised description for POS 3. CPT and HCPCS codes that are part of CMS NCCI edits code 22: On Campus - Outpatient Hospital These procedures include Moderate Sedation as an inherent part of providing the service. Refer to the list below for a comprehensive listing of the non- anesthesia procedures that include Moderate Sedation and for which CPT codes 99143-99145 will not be considered separately.

Procedures that include Moderate Sedation codes (99143-99145)

Note: Procedure codes that are listed in Appendix G of the CPT book that are also identified on the National Physicians Fee Schedule (NPFS) as Status B are addressed in the B Bundle Codes Policy.

Second Physician (99148-99150) Moderate Sedation services performed by a second physician, hospital, ambulatory surgical center, or other qualified health care professional (who is not performing the diagnostic or therapeutic procedure that the sedation

110 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Moderate Sedation Jan. 1, 2016 supports), should be reported as CPT codes 99148-99150. Reimbursement of (continued) CPT codes 99148-99150 based on the place of service is as follows:

Non-facility setting According to the AMA “When moderate sedation is performed in the non- facility setting, the efforts of the second physician are not reported with the codes in Appendix G because moderate sedation is included in these codes. Therefore, it would not be appropriate to separately report for moderate sedation.” Based on AMA guidelines, Oxford will reimburse CPT codes 99148- 99150 in a non-facility setting except when a procedure code listed in Appendix G of the CPT codebook is also reported on the same date of service by the same physician or other qualified health care professional.

Facility setting Moderate Sedation services reported as CPT codes 99148-99150 that are performed by a second physician, hospital, ambulatory surgical center, or other qualified health care professional in a facility place of service (see listing below) are eligible for reimbursement.

For purposes of this policy a facility place of service would include any of the following locations:  19 Off Campus-Outpatient Hospital  21 Inpatient Hospital  22 On Campus-Outpatient Hospital  23 Emergency Room-Hospital  24 Ambulatory Surgical Center  26 Military Treatment Facility  31 Skilled Nursing Facility  34 Hospice  41 Ambulance - Land  42 Ambulance - Air or Water  51 Inpatient Psychiatric Facility  52 Psychiatric Facility - Partial Hospitalization  53 Community Mental Health Center  56 Psychiatric Residential Treatment Center  61 Comprehensive Inpatient Rehabilitation Facility

Drug Reimbursement The cost of the drug used in Moderate Sedation, if supplied by the physician

111 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Moderate Sedation Jan. 1, 2016 in a location other than inpatient/outpatient hospital, emergency room or (continued) ambulatory surgical center, is reimbursable at the appropriate fee schedule or contracted rate. For additional information on drugs supplies in an inpatient/outpatient hospital, emergency room or ambulatory surgical center, refer to the Supply Policy.

The Current Procedural Terminology (CPT®) codes and Healthcare Common Procedure Coding System (HCPCS) codes listed in this policy are for reference purposes only. Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the member specific benefit document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other policies and coverage determination guidelines may apply. This list of codes may not be all inclusive.

CPT® Code Description Moderate sedation services (other than those services described by codes 00100-01999) provided by the same physician performing the diagnostic or therapeutic service 99143 that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patients level of consciousness and physiological status; under 5 years of age, first 30 minutes intra-service time Moderate sedation services (other than those services described by codes 00100-01999) provided by the same physician performing the diagnostic or therapeutic service 99144 that the sedation supports, requiring the presence of an independent trained observer to assist in the monitoring of the patients level of consciousness and physiological status; age 5 years or older, first 30 minutes intra-service time Moderate sedation services (other than those services described by codes 00100-01999) provided by the same physician performing the diagnostic or therapeutic service that the sedation supports, requiring the presence of an 99145 independent trained observer to assist in the monitoring of the patients level of consciousness and physiological status; each additional 15 minutes intra-service time (List separately in addition to code for primary service)

112 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Moderate Sedation Jan. 1, 2016 Moderate sedation services (other than those services (continued) described by codes 00100-01999), provided by a physician other than the health care professional performing the 99148 diagnostic or therapeutic service that the sedation supports; under 5 years of age, first 30 minutes intra- service time Moderate sedation services (other than those services described by codes 00100-01999), provided by a physician other than the health care professional performing the 99149 diagnostic or therapeutic service that the sedation supports; age 5 years or older, first 30 minutes intra- service time Moderate sedation services (other than those services described by codes 00100-01999), provided by a physician other than the health care professional performing the 99150 diagnostic or therapeutic service that the sedation supports; each additional 15 minutes intra-service time (List separately in addition to code for primary service) CPT® is a registered trademark of the American Medical Association.

Supply Policy Jan. 1, 2016  Revised reimbursement Supply Reimbursement for a Physician, Hospital, Ambulatory Surgical guidelines; updated list of facility Center or Other Qualified Health Care Professional setting/place of service (POS) Pursuant to Centers for Medicare and Medicaid Services (CMS) policy, certain codes: HCPCS supply codes are not separately reimbursable as the cost of supplies o Added POS code 19: Off is incorporated into the Practice Expense Relative Value Unit (RVU) for the Campus - Outpatient Hospital Evaluation and Management (E/M) service or procedure code. Consistent (new code effective Jan. 1, with CMS, Oxford will not separately reimburse the HCPCS supply codes 2016) when those supplies are provided on the same day as an E/M service and/or o Revised description for POS procedure performed by a physician, hospital, ambulatory surgical center, or code 22: On Campus - other qualified health care professional. Outpatient Hospital The Oxford Supply Policy Codes List (see Attachments section of the policy) contains the codes that are not separately reimbursable under this policy. It is developed based on the CMS National Physician Fee Schedule (NPFS) Relative Value File and consists of codes that based on their descriptions, CMS considers part of the practice expense and not separately reimbursable.

Supplies, Purchased Durable Medical Equipment (DME), Orthotics, Prosthetics, Biologicals and Drugs submitted with a J Code Reported

113 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Supply Policy Jan. 1, 2016 with a Facility Place of Service 19, 21, 22, 23, 24 (continued) CMS follows a Prospective Payment System (PPS) where Medicare payment is based on a predetermined, fixed amount payable to a facility for inpatient or outpatient hospital services. In addition, CMS reimburses ambulatory surgery centers under an Ambulatory Payment Classification (APC) payment methodology. With these fixed rates all costs associated with drugs and supplies are also deemed included in the global payment to the facility and not considered separately reimbursable when reported on a CMS-1500 claim form by a physician or other qualified healthcare professional.

Consistent with CMS, Oxford will not allow separate reimbursement for specific HCPCS supplies, purchased DME, orthotics, prosthetics, biological, and drugs reported with a HCPCS J code when submitted on a CMS-1500 claim form by any physician or other qualified healthcare professional in the following facility POS 19, 21, 22, 23, and 24.

The purchase of certain DME, orthotics, and prosthetics will not be separately reimbursed when reported by a physician or other qualified health care professional on a CMS-1500 claim form in POS 19, 21, 22, 23 or 24 and the services are reported with no modifier or with one of the following purchase modifiers:  NU New Equipment (use the NR modifier when DME which was new at the time of rental is subsequently purchased).  UE Used Equipment  NR New when rented  KM Replacement of facial prosthesis including new impression/moulage  KN Replacement of facial prosthesis using previous master model

Refer to the Attachments section of the policy for a list of those codes/services that are not separately reimbursable in POS 19, 21, 22, 23 and 24.

Durable Medical Equipment, Orthotics, Prosthetics, and Related Supplies Reported with Facility Places of Service 31 and 32 In alignment with the CMS PPS reimbursement methodology, Oxford considers payment for certain DME, orthotics, prosthetics and related supply items on the CMS Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) fee schedule to be included in the payment to the facility and not reimbursed separately when reported by a physician or other

114 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Supply Policy Jan. 1, 2016 qualified health care professional on a CMS-1500 claim form with one of the (continued) following facility POS:  POS 31: Skilled Nursing Facility  POS 32: Nursing Facility

Please refer to the attachments below for a list of codes/services that are not separately reimbursable in POS 31 and 32.

Casting and Splint Supplies HCPCS codes A4570, A4580, and A4590 which were previously used for billing of splints and casts are invalid for Medicare use effective July 1, 2001, and new temporary Q codes were established to reimburse physicians, hospitals, ambulatory surgical centers and other practitioners for the supplies used in creating casts. Consistent with CMS, Oxford will no longer reimburse HCPCS codes A4570, A4580, and A4590 for casting and splint supplies. Physicians, hospitals, ambulatory surgical centers and other qualified health care professionals should be using the temporary Q codes (Q4001-Q4051) for reimbursement of casting and splint supplies.

Implantable Tissue Markers CMS clarifies that implantable tissue markers (HCPCS code A4648) and implantable radiation dosimeters (HCPCS code A4650) are separately billable and payable when used in conjunction with CPT codes 19499, 32553, 49411 or 55876 on a claim for physician or other qualified health care professional services. Consistent with CMS, Oxford will allow separate reimbursement for HCPCS codes A4648 and A4650 when billed on the same date of service with either CPT codes 19499, 32553, 49411 or 55876. If not reported with at least one of these CPT codes, HCPCS codes A4648 and A4650 are not separately reimbursable.

Supply Code 99070

For reimbursement of covered medical and surgical supplies, an appropriate

Level II HCPCS code must be submitted. The non-specific CPT code 99070

(supplies and materials, except spectacles, provided by the physician,

hospital, ambulatory surgical center or other qualified health care

professional over and above those usually included with the office visit or

other services rendered (list drugs, trays, supplies, or materials provided)) is

not reimbursable in any setting.

115 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Telemedicine Policy Jan. 1, 2016  Revised reimbursement Telehealth Services guidelines; added language to Modifiers indicate: ® o Oxford will consider The Current Procedural Terminology (CPT ) and Healthcare Common reimbursement for a procedure Procedure Coding System (HCPCS) codes that describe a telehealth service code/modifier combination (a physician-patient encounter from one site to another) are generally the using modifier GQ to report same codes that describe an encounter when the physician and patient are Asynchronous at the same site. Telecommunications only when the modifier has been used The modifiers below describe the technology used to facilitate a Telehealth appropriately encounter. One of these modifiers should be reported when performing a o For a complete list of codes service via Telehealth to indicate the type of technology used and to that Oxford recognizes when differentiate a Telehealth encounter when the physician and patient are at reported with modifier GQ the same site. For more information see the Definitions section in this policy. refer to the list Codes Recognized with Modifier GQ Modifier Description  Revised Q&A; removed Q6A6 GQ Via Asynchronous Telecommunications systems pertaining to telehealth services Via Interactive Audio and Video GT billed with GQ modifier Telecommunications systems  Added list of Codes Recognized The Centers for Medicare and Medicaid Services (CMS) have authorized with Modifier GQ (attachment file specific Originating Sites as “eligible” for furnishing a Telehealth service. detailing codes Oxford recognizes When reporting modifier GT, the physician, hospital, ambulatory surgical when reported with modifier GQ) center, or qualified healthcare professional is certifying that they are

rendering services to a patient located in an eligible Originating Site via an

Interactive Audio and Visual Telecommunications system.

In accordance with CMS the eligible Originating Sites are listed below:

 The office of a physician or practitioner;

 A hospital (inpatient or outpatient);

 A critical access hospital (CAH);

 A rural health clinic (RHC);

 A federally qualified health center (FQHC);

 A hospital-based or critical access hospital-based renal dialysis center

(including satellites);

 A skilled nursing facility (SNF); and

 A community mental health center (CMHC)

CMS has also authorized which practitioners may be reimbursed for

116 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Telemedicine Policy Jan. 1, 2016 Telehealth services. In accordance with CMS these practitioners are listed (continued) below:  Physician  Nurse practitioner  Physician assistant  Nurse-midwife  Clinical nurse specialist  Clinical psychologist  Clinical social worker  Registered dietitian or nutrition professional

Note: Clinical psychologists (CP) and clinical social workers (CSW) cannot bill for psychiatric diagnostic interview examinations with medical services or medical evaluation and management services under Medicare. These practitioners may not bill or receive payment for Current Procedural Terminology (CPT) codes 90792, 90833, 90836, and 90838.

The use of modifier GT indicates a Telehealth service was performed by an eligible practitioner via an Interactive Audio-Visual Telecommunications system and the patient was present at an eligible Originating Site.

Reimbursement

Oxford will reimburse for Telehealth services which are recognized by CMS when reported with modifier GT (Interactive Telecommunications). In addition, Oxford recognizes that medical genetics and genetic counseling services (CPT code 96040), education and training for patient self- management by a qualified, nonphysician health care professional using a standardized curriculum (CPT codes 98960-98962), and alcohol and/or substance abuse screening and brief intervention services (CPT codes 99408- 99409) can be effectively performed via Interactive Audio and Video Telecommunications systems; these codes will be allowed for reimbursement when reported with modifier GT. Oxford will also reimburse CPT codes 0188T and 0189T when these codes are reported with or without a modifier GT, since the description for these codes indicates a Telehealth service and the technology used.

Any other service reported with a modifier GT that is not recognized by CMS will not be reimbursed.

117 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Telemedicine Policy Jan. 1, 2016 For a complete list of codes that Oxford recognizes when reported with (continued) modifier GT refer to: Codes Recognized with Modifier GT.

Oxford will not reimburse Telehealth services submitted with modifier GQ

(Asynchronous Telecommunications) because these services do not include

direct, in-person patient contact.

Oxford will consider reimbursement for a procedure code/modifier combination using modifier GQ to report Asynchronous Telecommunications only when the modifier has been used appropriately.

For a complete list of codes that Oxford recognizes when reported with modifier GQ refer to: Codes Recognized with Modifier GQ.

Oxford will not reimburse for HCPCS code T1014 (Telehealth transmission, per minute, professional services bill separately) because these services are included in Telehealth services.

Telemedicine Services

Telephone Calls Oxford follows CMS guidelines and does not reimburse for telephone charges submitted with Current Procedural Terminology (CPT) codes 98966-98968 or 99441-99443 because they do not involve direct, in-person patient contact.

Internet Services Oxford follows CMS guidelines and does not reimburse for CPT codes 98969 and 99444 (Online Medical Evaluation), because these services do not involve direct, in person patient contact.

Consultation Services

Oxford follows CMS guidelines and does not reimburse for interprofessional telephone/Internet assessment and management services reported with CPT codes 99446-99449 because they do not involve direct, in-person patient contact.

The Current Procedural Terminology (CPT®) codes and Healthcare Common Procedure Coding System (HCPCS) codes listed in this policy are for reference purposes only. Listing of a service code in this policy does not imply that the service described by this code is a covered or non-covered health service. Coverage is determined by the member specific benefit

118 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Telemedicine Policy Jan. 1, 2016 document and applicable laws that may require coverage for a specific (continued) service. The inclusion of a code does not imply any right to reimbursement or guarantee claims payment. Other policies and coverage determination guidelines may apply. This list of codes may not be all inclusive.

Non-Reimbursable CPT® Codes ® CPT Codes Description Telephone assessment and management service provided by a qualified nonphysician health care professional to an established patient, parent, or guardian not originating from a related assessment and management service 98966 provided within the previous seven days nor leading to an assessment and management service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion Telephone assessment and management service provided by a qualified nonphysician health care professional to an established patient, parent, or guardian not originating from a related assessment and management service 98967 provided within the previous seven days nor leading to an assessment and management service or procedure within the next 24 hours or soonest available appointment; 11- 20 minutes of medical discussion Telephone assessment and management service provided by a qualified nonphysician health care professional to an established patient, parent, or guardian not originating from a related assessment and management service 98968 provided within the previous seven days nor leading to an assessment and management service or procedure within the next 24 hours or soonest available appointment; 21- 30 minutes of medical discussion Online assessment and management service provided by a qualified nonphysician health care professional to an established patient, guardian, or health care provider not 98969 originating from a related assessment and management service provided within the previous 7 days, using the Internet or similar electronic communications network Telephone evaluation and management service provided 99441 by a physician to an established patient, parent, or

119 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Telemedicine Policy Jan. 1, 2016 guardian not originating from a related E/M service (continued) provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion Telephone evaluation and management service provided by a physician to an established patient, parent, or guardian not originating from a related E/M service 99442 provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 11-20 minutes of medical discussion Telephone evaluation and management service provided by a physician to an established patient, parent, or guardian not originating from a related E/M service 99443 provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 21-30 minutes of medical discussion Online evaluation and management service provided by a physician to an established patient, guardian, or health 99444 care provider not originating from a related E/M service provided within the previous 7 days, using the Internet or similar electronic communications network Interprofessional telephone/Internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's 99446 treating/requesting physician or other qualified health care professional; 5-10 minutes of medical consultative discussion and review Interprofessional telephone/Internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's 99447 treating/requesting physician or other qualified health care professional; 11-20 minutes of medical consultative discussion and review Interprofessional telephone/Internet assessment and 99448 management service provided by a consultative physician including a verbal and written report to the patient's

120 Oxford® Policy Update Bulletin: December 2015 Oxford

Reimbursement Policy Updates

REVISED Policy Title Effective Date Summary of Changes Reimbursement Guidelines Telemedicine Policy Jan. 1, 2016 treating/requesting physician or other qualified health care (continued) professional; 21-30 minutes of medical consultative discussion and review Interprofessional telephone/Internet assessment and management service provided by a consultative physician including a verbal and written report to the patient's 99449 treating/requesting physician or other qualified health care professional; 31 minutes or more of medical consultative discussion and review CPT® is a registered trademark of the American Medical Association.

Non-Reimbursable HCPCS Code (regardless of appended modifier) HCPCS Code Description Telehealth transmission, per minute, professional services T1014 bill separately

121 Oxford® Policy Update Bulletin: December 2015