mm/01/2016: oxford® policy update bulletin: month 2016

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

March 2016

policy update bulletin Medical & Administrative Policy Updates

2 Oxford® Policy Update Bulletin: March 2016

Oxford® Medical and Administrative Policy Updates

Overview

Tips for using the Policy Update Bulletin:

From the table of contents, click the policy title to be

directed to the corresponding policy update summary.

From the policy updates table, click the policy title to view a

complete copy of a new, updated, or revised policy.

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review requirements

have been adopted for a service, procedure, test, or device

Updated

An existing policy has been reviewed and changes have not been made

to the clinical coverage criteria or documentation review requirements;

however, items such as the clinical evidence, FDA information, and/or

list(s) of applicable codes may have been updated

Revised

An existing policy has been reviewed and revisions have been made to

the clinical coverage criteria and/or documentation review requirements

Replaced

An existing policy has been replaced with a new or different policy

Retired

The procedural codes and/or services previously outlined in the policy are

no longer being managed or are considered to be proven/medically

necessary and are therefore not excluded as unproven/not medically

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

coverage. As always, coverage for a service or procedure must be

determined in accordance with the member’s benefit plan and any

applicable federal or state regulatory requirements. Additionally,

UnitedHealthcare reserves the right to review the clinical evidence

supporting the safety and effectiveness of a medical technology prior to

rendering a coverage determination.

This bulletin provides complete details on Oxford® Medical and

Administrative Policy updates. The appearance of a service or

procedure in this bulletin indicates only that Oxford® has recently

adopted a new policy and/or updated, revised, replaced or

retired an existing policy; it does not imply that Oxford® provides

coverage for the service or procedure. In the event of an

inconsistency or conflict between the information provided in this

bulletin and the posted policy, the provisions of the posted policy

will prevail. Note that most benefit plan documents exclude from

benefit coverage health services identified as investigational or

unproven/not medically necessary. Physicians and other health

care professionals may not seek or collect payment from a

member for services not covered by the applicable benefit plan

unless first obtaining the member’s written consent,

acknowledging that the service is not covered by the benefit plan

and that they will be billed directly for the service.

A complete library of Oxford® Medical and Administrative

Policies is available at OxfordHealth.com > Providers >

Tools & Resources > Medical Information > Medical and

Administrative Policies.



In This Issue

Clinical Policy Updates Page

NEW

Functional Endoscopic Sinus Surgery (FESS) - Effective May 1, 2016 ...................................................................................................................... 7

UPDATED

Alemtuzumab - Effective Apr. 1, 2016 ................................................................................................................................................................. 7 Blepharoplasty, Blepharoptosis and Brow Ptosis Repair - Effective Apr. 1, 2016 ........................................................................................................ 9 Bone or Soft Tissues Healing and Fusion Enhancement Products - Effective Mar. 1, 2016 ........................................................................................ 14 Breast Reduction Surgery - Effective Apr. 1, 2016 .............................................................................................................................................. 19 Cytological Examination of Breast Fluids for Cancer Screening - Effective Apr. 1, 2016 ............................................................................................ 22 Fecal Calprotectin Testing - Effective Mar. 1, 2016 .............................................................................................................................................. 22 Gastrointestinal Motility Disorders, Diagnosis and Treatment - Effective Apr. 1, 2016 .............................................................................................. 23 Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable - Effective Apr. 1, 2016 ........................................................... 24 Home Health Care - Effective Apr. 1, 2016......................................................................................................................................................... 26 Home Hemodialysis - Effective Mar. 1, 2016 ...................................................................................................................................................... 28 Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Infusion - Effective Apr. 1, 2016 ......................... 29 Lupron-Depot / Lupron-Depot Ped (Leuprolide Acetate) - Effective Mar. 1, 2016 .................................................................................................... 31 Rhinoplasty and Other Nasal Surgeries - Effective Apr. 1, 2016 ............................................................................................................................ 34 Surgical and Ablative Procedures for Venous Insufficiency and Varicose Veins - Effective Apr. 1, 2016 ...................................................................... 36 Synagis (Palivizumab) - Effective Apr. 1, 2016 ................................................................................................................................................... 38 Total Artificial Disc Replacement for Spine - Effective Apr. 1, 2016 ....................................................................................................................... 42 Transcranial Magnetic Stimulation - Effective Mar. 1, 2016 .................................................................................................................................. 43 Visual Information Processing Evaluation and Orthoptic and Vision Therapy - Effective Mar. 1, 2016 ......................................................................... 44

REVISED

Abnormal Uterine Bleeding and Uterine Fibroids - Effective Apr. 1, 2016................................................................................................................ 45 Attended Polysomnography for Evaluation of Sleep Disorders - Effective Apr. 1, 2016 ............................................................................................. 47 Bariatric Surgery - Effective Apr. 1, 2016 .......................................................................................................................................................... 50 Botulinum Toxins A and B - Effective Apr. 1, 2016 .............................................................................................................................................. 53 Clotting Factors and Coagulant Blood Products - Effective Apr. 1, 2016 ................................................................................................................. 53 Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes - Effective Apr. 1, 2016 ......................................................................... 55 Cosmetic and Reconstructive Procedures - Effective Apr. 1, 2016 ......................................................................................................................... 57 Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Apr. 1, 2016 ................................................................................ 58 Drug Coverage Guidelines - Effective Feb. 3, 2016.............................................................................................................................................. 58



In This Issue

o Entresto (Valsartan – Sacubitril) ................................................................................................................................................................. 58 Drug Coverage Guidelines - Effective Mar. 15, 2016............................................................................................................................................ 59

o Zepatier (Elbasvir/ Grazoprevir) .................................................................................................................................................................. 59 Drug Coverage Guidelines - Effective Apr. 1, 2016 .............................................................................................................................................. 59

o Adempas (Riociguat) ................................................................................................................................................................................. 59 o Cotellic (Cobimetinib) ................................................................................................................................................................................ 60 o Dyanavel XR (Amphetamine) ...................................................................................................................................................................... 60 o Entresto (Valsartan – Sacubitril) ................................................................................................................................................................. 60 o Epaned (Enalapril) .................................................................................................................................................................................... 62 o Finacea 15% Foam (Azelaic Acid) ................................................................................................................................................................ 62 o Genvoya .................................................................................................................................................................................................. 62 o Histex-AC Syrup (Codeine/Phenylephrine/Triprolidine) ................................................................................................................................... 62 o Imatinib (Generic Gleevec) ......................................................................................................................................................................... 62 o Keveyis (Dichlorphenamide) ....................................................................................................................................................................... 63 o Nexium Suspension (Esomeprazole) ............................................................................................................................................................ 63 o Ninlaro (Ixazomib) .................................................................................................................................................................................... 63 o Orenitram (Treprostinil) ............................................................................................................................................................................. 64 o Prevacid (Lansoprazole) Solutab Lansoprazole Generic .................................................................................................................................. 65 o Purixan 20mg/ml (Mercaptopurine) ............................................................................................................................................................. 65 o Repatha (Evolocumab) .............................................................................................................................................................................. 66 o Sotylize (Sotalol Hydrochloride) .................................................................................................................................................................. 67 o Stribild® (Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Disoproxil Fumarate) ................................................................................................ 67 o Tagrisso (Osimertinib) ............................................................................................................................................................................... 67 o Uptravi (Selexipag) ................................................................................................................................................................................... 68 o Zegerid Suspension (Omeprazole/Sodium Bicarbonate) ................................................................................................................................. 69

Elbow Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2016 ...................................................................................................................... 69 Electrical and Ultrasound Bone Growth Stimulators - Effective Apr. 1, 2016 ........................................................................................................... 69 Entyvio™ (Vedolizumab) - Effective Apr. 1, 2016 ................................................................................................................................................ 70 Genetic Testing - Effective Apr. 1, 2016 ............................................................................................................................................................ 71 Hip Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2016 .......................................................................................................................... 76 Hysterectomy for Benign Conditions - Effective Apr. 1, 2016 ................................................................................................................................ 76 Implanted Electrical Stimulator for Spinal Cord - Effective Apr. 1, 2016 ................................................................................................................. 77 Manipulative Therapy - Effective Apr. 1, 2016 .................................................................................................................................................... 77 Observation Care - Effective Apr. 1, 2016 .......................................................................................................................................................... 78 Obstructive Sleep Apnea Treatment - Effective Apr. 1, 2016 ................................................................................................................................ 79 Occipital Neuralgia and Headache Treatment - Effective Apr. 1, 2016 .................................................................................................................... 82 Orthognathic (Jaw) Surgery - Effective Apr. 1, 2016 ........................................................................................................................................... 83



In This Issue

Oscillatory Positive Expiratory Pressure Devices - Effective Apr. 1, 2016 ................................................................................................................ 86 Oxford's Outpatient Imaging Self-Referral Policy - Effective Apr. 1, 2016 ............................................................................................................... 86 Panniculectomy and Body Contouring Procedures - Effective Apr. 1, 2016 ............................................................................................................. 86 Pneumatic Compression Devices - Effective Apr. 1, 2016 ..................................................................................................................................... 88 Preventive Care Services - Effective Apr. 1, 2016 ............................................................................................................................................... 89 Private Duty Nursing - Effective Apr. 1, 2016 ..................................................................................................................................................... 90 Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs - Effective Apr. 1, 2016 .......................................................................... 91 Radiology Procedures Requiring Precertification for eviCore Healthcare Arrangement - Effective Apr. 1, 2016 ............................................................ 97 Radiopharma-ceuticals and Contrast Media - Effective Apr. 1, 2016 ...................................................................................................................... 97 Shoulder Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2016 ................................................................................................................. 102 Specialty Medication Administration - Site of Care Review Guidelines - Effective Apr. 1, 2016 ................................................................................. 103 Surgical Treatment for Spine Pain - Effective Apr. 1, 2016 .................................................................................................................................. 104 Temporomandibular Joint Disorders - Effective Apr. 1, 2016 ............................................................................................................................... 106 Total Knee Replacement Surgery (Arthroplasty) - Effective Apr. 1, 2016 .............................................................................................................. 108 Vaccines - Effective Apr. 1, 2016 ..................................................................................................................................................................... 108 Wearable Cardioverter-Defibrillators - Effective Apr. 1, 2016 ............................................................................................................................... 109

Administrative Policy Updates

UPDATED

Behavioral Health Services - Effective Mar. 1, 2016 ........................................................................................................................................... 110 New York Participating Provider Laboratory & Pathology Protocol - Effective Mar. 1, 2016 ....................................................................................... 112 Speech Therapy and Early Intervention Programs/Birth to Three - Effective Mar. 1, 2016 ....................................................................................... 115

REVISED

Autism - Effective Apr. 1, 2016 ....................................................................................................................................................................... 115 Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies, and Repairs/ Replacements - Effective Apr. 1, 2016 ................................. 117 Orthopedic Services - Effective Apr. 1, 2016 ..................................................................................................................................................... 118 Timeframe Standards for Utilization Management (UM) Initial Decisions - Effective Apr. 1, 2016 ............................................................................. 120

RETIRED/REPLACED

Medical Supplies - Effective Mar. 1, 2016 .......................................................................................................................................................... 120



In This Issue

Reimbursement Policy Updates

NEW

Physical Medicine & Rehabilitation: Multiple Therapy Procedure Reduction Policy - Effective Apr. 1, 2016 .................................................................. 121 Replacement Codes - Effective Apr. 1, 2016 ...................................................................................................................................................... 122

UPDATED

After Hours and Weekend Care Policy - Effective Mar. 1, 2016 ............................................................................................................................ 123 Increased Procedural Services - Effective Mar. 1, 2016 ....................................................................................................................................... 124 Modifier SU Policy - Effective Mar. 1, 2016 ........................................................................................................................................................ 125 Nonphysician Health Care Codes Policy - Effective Mar. 1, 2016 .......................................................................................................................... 126 Observation Care and Evaluation and Management Codes - Effective Mar. 1, 2016 ................................................................................................ 126 Once in a Lifetime Procedures - Effective Mar. 1, 2016 ....................................................................................................................................... 129 Standby Services - Effective Mar. 1, 2016 ........................................................................................................................................................ 130 T Status Codes - Effective Mar. 1, 2016 ............................................................................................................................................................ 130

REVISED

Maximum Frequency Per Day - Effective Apr. 1, 2016 ........................................................................................................................................ 131 Moderate Sedation - Effective Apr. 1, 2016 ....................................................................................................................................................... 136 Obstetrical Policy - Effective Apr. 1, 2016 ......................................................................................................................................................... 138


Clinical Policy Updates

NEW

Policy Title Effective Date Coverage Rationale

Functional Endoscopic Sinus Surgery (FESS)

May 1, 2016 Please note: Medical necessity reviews will also include site of service (SOS), per the member’s benefit plan. Please refer to Site of Service Guidelines for Certain Outpatient Surgical Procedures for additional information on SOS reviews for these services.

Functional endoscopic sinus surgery (FESS) is medically necessary for one or more of the following: Patients with chronic rhinosinusitis (defined as rhinosinusitis lasting longer than 12 weeks) with both of the

following: o Chronic rhinosinusitis is confirmed on computed tomography (CT) scan by one or more of the following:

Mucosal thickening Bony remodeling Bony thickening or

Obstruction of the ostiomeatal complex Opacified sinus

o Symptoms persist despite medical therapy with one or more of the following: Nasal lavage Antibiotic therapy, if bacterial infection is suspected Intranasal corticosteroids

Mucocele documented on CT scan

Complications of sinusitis such as abscess Tumor documented on CT scan (such as polyposis or malignancy) Recurrent acute rhinosinusitis (RARS) Drug eluting stents or implants are unproven and not medically necessary for maintaining sinus ostial patency after sinus surgery.

The evidence is insufficient to determine whether sinus stents improve outcomes when used postoperatively following endoscopic sinus surgery. Further randomized clinical trials are needed that compare the devices to postoperative care without the device to determine whether they can improve postoperative outcomes for patients undergoing endoscopic sinus surgery.

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Alemtuzumab

Apr. 1, 2016

Added reference link to policy

titled Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines

Updated list of applicable ICD-9 codes associated with deleted code J9010; removed V42.0,

Note: This policy applies only to non-oncology indications. For additional

information regarding oncology indications, please refer to policy: Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines. Campath (alemtuzumab) is proven and medically necessary when used in the treatment of:



UPDATED


Alemtuzumab (continued)

Apr. 1, 2016

V42.1, V42.6, V42.7, V42.81, V42.82, V42.83 and V42.84

Updated list of applicable ICD-10 codes: o Replaced G35.0 with G35

(multiple sclerosis)

o Removed Z94.0, Z94.1, Z94.2, Z94.3, Z94.4, Z94.81, Z94.82, Z94.83 and Z94.84 (codes associated with deleted code J9010)

1. Members undergoing peripheral blood stem cell (PBSC) and/or bone marrow transplantation1-5

2. Members undergoing solid organ transplantation6, 20-25 *Effective September 4th, 2012, Campath will no longer be available

commercially, but will be provided through the Campath Distribution Program

free of charge. Additional details about this program may be found at http://www.campath.com. Oxford will not provide coverage of Campath in relapsing-remitting multiple sclerosis (RRMS).

Lemtrada (alemtuzumab) is proven and medically necessary for treatment of relapsing-remitting multiple sclerosis when all of the following criteria are met: A. Diagnosis of relapsing-remitting multiple sclerosis (RRMS); and B. One of the following:

1. Treatment - naïve to alemtuzumab:

a. Member has history of failure following a trial for at least 4 weeks or history of intolerance or contraindication to two of the following: 1) interferon β-1a (Avonex® or Rebif®)) 2) interferon β-1b (Betaseron® or Extavia®) 3) glatiramer acetate (Copaxone®)

4) dimethyl fumarate (Tecfidera®) 5) teriflunomide (Aubagio®) 6) fingolimod (Gilenya®) 7) peginterferon beta-1a (Plegridy™)

and b. Member has not been previously treated with alemtuzumab; and c. Member is not receiving alemtuzumab in combination with another

disease modifying agent (e.g., interferon beta preparations, glatiramer acetate, natalizumab, fingolimod, or teriflunomide); and

d. Initial dosing is administered: 12 mg intravenously daily for 5 consecutive days; and

e. Regimen is administered only once within 12 months

http://www.campath.com./



UPDATED


Alemtuzumab (continued)

Apr. 1, 2016 or 2. Treatment-experienced with alemtuzumab:

a. Member has previously received treatment with alemtuzumab; and

b. Member is not receiving alemtuzumab in combination with another

disease modifying agent (e.g., interferon beta preparations,

glatiramer acetate, natalizumab, fingolimod, or teriflunomide); and

c. Retreatment dosing is administered: 12 mg intravenously daily for 3 consecutive days; and

d. Regimen is administered only once within 12 months

Coverage of Lemtrada is limited up to two treatment courses (5 day initial and 3 day end course). Requests for additional doses/courses beyond two courses will not be approved. Oxford will not provide coverage of Lemtrada for indications other than relapsing-remitting multiple sclerosis RRMS.

Alemtuzumab is unproven and not medically necessary for the treatment of: 1. Rheumatoid arthritis 2. Autoimmune neutropenia 3. Autoimmune hemolytic anemia 4. Pure red cell aplasia

5. Immune thrombocytopenic purpura 6. Evan's syndrome 7. Autoimmune pancytopenia

Blepharoplasty,

Blepharoptosis and Brow Ptosis Repair

Apr. 1, 2016

Updated supporting information;

replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care

Guidelines, 20th edition, 2016” (effective Apr. 1, 2016)

Indications for Coverage

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 the member specific

benefit document. Criteria for a Coverage Determination that Surgery is Reconstructive and Medically Necessary: The following must be available when requested by Oxford: Best corrected visual acuity in both eyes, all patients (except pediatrics).



UPDATED


Blepharoplasty, Blepharoptosis and Brow Ptosis Repair (continued)

Apr. 1, 2016

Eye exam (chief complaint, HPI). Color photograph(s) (eye level, frontal with patient looking straight ahead,

light reflex visible and centered). Peripheral or superior visual fields automated, reliable (see Definitions),

untaped/taped are preferable. Note the following:

o In situations where computerized visual field testing is not available we

will accept manual visual field testing. o In situations where visual field testing is not possible, see section

below, “When Patient is Not Capable of Visual Field Testing.”

Note: The visual fields and color photograph(s) must be consistent.

If multiple procedures are requested the following criteria must be met: 1. All criteria for each individual procedure must be met; and 2. Visual field testing shows visual impairment which can’t be addressed by

one procedure alone; and 3. Color photograph findings are consistent with visual field findings.

A. Upper eyelid blepharoplasty (CPT 15822 and 15823) is considered reconstructive and medically necessary when the following criteria are present: 1. Ptosis has been ruled out as the primary cause of visual field

obstruction; and 2. The color photograph must show:

i. The extra skin, but NOT the lid margin, taped up to show it reverses the visual field obstruction; and/or

ii. Lateral hooding present,

and

3. The patient must have a Functional/Physical Impairment complaint directly related to an abnormality of the eyelid(s); and

4. Excess skin (dermatochalasis/blepharochalasis) touches the lashes; and

5. Automated peripheral or superior visual field testing, with the eyelids taped and untaped, showing improvement of 30% or more in number

of points seen. In situations where computerized visual field testing is not available

we will accept manual visual field testing. In situations where visual field testing is not possible, see section



UPDATED



Apr. 1, 2016

below, “When Patient is Not Capable of Visual Field Testing.” Note: Extended blepharoplasty may be indicated for blepharospasm (eyelids are forced shut) when the following two criteria are met: 1. Debilitating symptoms (e.g., pain); and

2. Conservative treatment has been tried and failed, or is

contraindicated (e.g., Botox®).

B. Upper eyelid blepharoptosis repair (CPT 67901– 67909) is considered reconstructive and medically necessary when the following criteria are present: 1. The patient must have a Functional/Physical Impairment complaint

directly related to the position of the eyelid(s); and 2. Other causes of ptosis are ruled out (e.g., recent botox injections,

myasthenia gravis when applicable); and 3. Eyelid droop (upper eyelid ptosis) and an MRD-1 of 2.0 mm or less;

and 4. The MRD is documented in color photographs with patient looking

straight ahead and light reflex centered on the pupil; and

5. Automated peripheral or superior visual field testing, with the eyelids taped and untaped, showing improvement of 30% or more improvement in the number of points seen. In situations where computerized visual field testing is not available

we will accept manual visual field testing. In situations where visual field testing is not possible, see section

within this policy titled, “When Patient is Not Capable of Visual Field Testing.”

Note: For children under age 10 years, ptosis repair is covered to

prevent amblyopia. Visual field testing is not required, but, a color photograph is required.

C. Brow ptosis (CPT 67900) is considered reconstructive and medically necessary when the following criteria are present: 1. Other causes have been eliminated as the primary cause for the visual

field obstruction (e.g., Botox® treatments within the past six (6) months); and

2. Patient must have a functional complaint related to brow ptosis. Brow ptosis must be documented in and two color photographs. One



UPDATED



Apr. 1, 2016

showing the eyebrow below the bony superior orbital rim, and a second photograph with the brow taped up that eliminates the visual field defect; and Automated peripheral and superior visual field testing, with

differential taping (eyebrow and eyebrow + eyelid) showing 30% or

more improvement in total number of points seen with the eyebrow

taped up. In situations where computerized visual field testing is not available we will accept manual visual field testing.

In situations where visual field testing is not possible, see section below, “When Patient is Not Capable of Visual Field Testing.”

D. Eyelid surgery with an anophthalmic socket (has no eyeball) is

considered reconstructive and medically necessary when both of the following criteria are present: 1. Patient has an anophthalmic condition; and 2. Patient is experiencing difficulties fitting or wearing an ocular

prosthesis.

E. Lower eyelid blepharoplasty (CPT 15820 and 15821) is usually

cosmetic, however, is considered reconstructive and medically necessary only when all of the following criteria are present: 1. There is documented facial nerve damage; and 2. Color photograph documents the pathology; and 3. Patient is unable to close the eye due to the lower lid dysfunction; and 4. Functional impairment including both of the following:

i. Documented uncontrolled tearing or irritation; and

ii. Conservative treatments tried and failed.

F. Ectropion (eyelid turned outward) (CPT 67914 through 67917) or

punctal eversion is considered reconstructive and medically necessary when all of the following criteria are present: 1. Color photograph documents the pathology; and 2. Conservative treatments have been tried and failed; and 3. Corneal or conjunctival injury with both of the following criteria:

i. Subjective symptoms include either:

a. Pain or discomfort; or b. Excess tearing; and

ii. Any one of the following:

a. Exposure keratitis; and/or



UPDATED



Apr. 1, 2016

b. Keratoconjunctivitis; and/or c. Corneal ulcer.

G. Entropion (eyelid turned inward) (CPT 67921-67924) is considered

reconstructive and medically necessary when all of the following

criteria are present:

1. Color photograph must document the following:

i. Lid turned inward; and

ii. At least one of the following:

a. Trichiasis; or b. Irritation of cornea or conjunctiva; and

2. Conservative treatments have been tried and failed; and 3. Subjective symptoms including either of the following:

i. Excessive tearing; or

ii. Pain or discomfort.

H. Lid Retraction Surgery (CPT 67911) Lid retraction surgery is

considered reconstructive and medically necessary when all of the

following criteria are present: 1. Other causes have been eliminated as the reason for the lid retraction

such as use of dilating eye drops, glaucoma medications; and 2. Color photograph documents the pathology; and 3. There is functional impairment (such as ‘dry eyes’, pain/discomfort,

tearing, blurred vision); and 4. Tried and failed conservative treatments; and

5. In cases of thyroid eye disease two or more Hertel measurements at least 6 months apart with the same base measurements are unchanged.

I. Canthoplasty/Canthopexy (CPT 21280, 21282, 67950, 67961, 67966) is considered reconstructive and medically necessary when all of the following criteria are present:

1. Functional impairment; and 2. Conservative treatment treatments have been tried and failed; and 3. Color photograph documents the pathology; and 4. Simple repair of ectropion or entropion will not correct condition; and 5. At least one of the following patient complaints is present:

i. Epiphora (excess tearing) not resolved by conservative measures;



UPDATED



Apr. 1, 2016 or

ii. Corneal dryness unresponsive to lubricants; or

iii. Corneal ulcer.

When Patient Is Not Capable of Visual Field Testing: Visual field testing is not required when the patient is not capable of

performing a visual field test. The following are some examples: If the patient is a child 12 years old or under.

If the patient has intellectual disabilities (previously known as mental retardation) or some other severe neurologic disease.

Coverage Limitations and Exclusions Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to enrollee’s

specific benefit documents. Cosmetic Procedures are excluded from coverage:

A. Procedures that correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other

procedures done to relieve such consequences or behavior) as a reconstructive procedure.

B. Any procedure that does not meet the reconstructive criteria above in the Indications for Coverage section.

Bone or Soft Tissues Healing and Fusion

Enhancement Products

Mar. 1, 2016

Updated benefit considerations; added language to indicate: o The 2007 generic Certificate

of Coverage (COC) states that devices which are FDA approved under the Humanitarian Use Device exemption are not considered to be experimental or

investigational o When reviewing for coverage

of a humanitarian use device

Bone graft materials used in spinal fusion surgery can be categorized into the following domains: Autografts

Allografts including (cadaver bone graft) Amniotic tissue membrane Demineralized Bone Matrix (DBM) Bone Morphogenetic Proteins (BMP) Ceramic-based products Cell-based products

Platelet-Rich Plasma Autografts



UPDATED


Bone or Soft Tissues Healing and Fusion Enhancement Products

(continued)

Mar. 1, 2016

(HUD), the coverage determination on an HUD will be made according to the hierarchy of evidence applied towards the evaluation of any

technology, in the same way

the evaluation would be applied to a service or technology that is FDA approved without a HUD exemption

Updated coverage rationale;

added language pertaining to clinical evidence/study findings for cell-based products to indicate: o Evidence in the published

scientific literature has not

demonstrated an improved

health outcome benefit over standard therapies

o Well-designed, large randomized comparative clinical trials are needed to demonstrate the efficacy and

safety of MSC therapy for orthopedic indications

Reorganized and revised definitions:

o Updated definition of “allograft”

o Added definition of “anorganic

bone graft materials” o Removed definition of

“xenografts” Updated lists of applicable codes:

o Reorganized list of applicable CPT/HCPCS codes by coverage status

Autografts are proven and medically necessary for bone fusion enhancement: Autografts harvest bone for grafting from the person undergoing surgery. The harvested bone is typically retrieved from the patient’s own tibia, fibula or iliac crest and then placed at the surgery site.

Allografts Demineralized bone matrix (DBM) is a type of allograft and is proven and medically necessary for bone fusion enhancement. DBM is human bone processed with hydrochloric acid to remove mineral content. Allografts are proven and medically necessary for bone fusion

enhancement. Allografts harvest bone for grafting from a person other than the surgical candidate. Cadaver bone is one type of allograft. Amniotic Tissue Membrane The use of amniotic membrane products in the treatment of spine

disease or in spine surgery is unproven and not medically necessary

due to insufficient clinical evidence of safety and/or efficacy in published peer-reviewed medical literature. Evidence is limited to animal studies only. No current clinical trials with humans were identified. There is limited evidence that amniotic tissue membrane improves health outcomes when used in lumbar spine fusion. Long term safety and efficacy have not been established.

Bone Morphogenetic Proteins (BMP) Bone Morphogenetic Protein-2 (rhBMP-2)

Note: As indicated in the Clinical Evidence section of the policy, the use of

bone morphogenic protein as an adjunct to spinal fusion surgery may be associated with significant adverse events. Thus, before using bone morphogenic protein, the physician should engage in a shared decision-making process with the patient, discussing the potential advantages, harms and alternatives to the use of bone morphogenic protein as an adjunct to

spinal fusion surgery. Infuse® Bone Graft is proven and medically necessary for the enhancement of bone healing and/or fusion of the lumbar spine in



UPDATED



(continued)

Mar. 1, 2016

(“proven/medically necessary” vs. “unproven/not medically necessary”)

o Removed coding clarification statement indicating most

bone healing and fusion

enhancement products are not represented by a specific CPT/HCPCS code; it may be necessary to use the most closely appropriate code and supplement with specific

comments in the precertification documentation

Updated supporting information to reflect the most current clinical evidence, FDA information and references

patients who meet all of the following criteria: Implanted via an anterior approach and used in conjunction with an Infuse

Bone Graft fusion device Infuse Bone Graft fusion devices include: o Infuse™ bone graft/LT-Cage

o Infuse™ bone graft/Lumbar Tapered Fusion Device

o Infuse™ bone graft/InterFix™ threaded fusion device o Infuse™ bone graft/Inter Fix™ RP threaded fusion device

Skeletally mature patient (18 years of age or older or radiographic evidence of epiphyseal closure) with degenerative disc disease at one level from L4–S1

No more than Grade I spondylolisthesis at the involved level

Failure of at least 6 months of non-operative treatment Infuse® Bone Graft is unproven and not medically necessary for all other indications including but not limited to the following: Enhancement of bone healing and/or fusion of the lumbar spine via a

posterior approach.

Treatment of cervical spine or any other area with or without use of other

devices including the PEEK device. Known contraindications including:

o hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation

o Pregnancy o Active infection at operative site or patient has an allergy to titanium or

titanium alloy Planned use of grafting in the vicinity of a resected or extant tumor Skeletally immature patient (younger than 18 years of age or 18 years of

age or older with no radiographic evidence of epiphyseal closure)

Note: The Infuse Bone Graft is also known as bone morphogenic, or morphogenetic protein-2, BMP-2.

Posterolateral or posterior lumbar interbody fusion utilizing Infuse Bone Graft has not received FDA approval. Available studies have demonstrated increased adverse events with the posterior approach. The safety and effectiveness of Infuse Bone Graft in the cervical spine have not been demonstrated. There is insufficient clinical evidence to support the use of Infuse Bone Graft with devices made of PEEK or other biocompatible



UPDATED



(continued)

Mar. 1, 2016

materials. In addition, Infuse Bone Graft has not been approved by the FDA for use with PEEK cages. When used according to U.S. Food and Drug Administration (FDA) indications, the Infuse/MASTERGRAFTTM Posterolateral Revision

Device system is proven and medically necessary in patients who

meet all of the following criteria: Implanted via a posterolateral approach Presence of symptomatic posterolateral lumbar spine pseudoarthrosis Skeletally mature patient (older than 21 years of age or radiographic

evidence of epiphyseal closure) Treatment of 2 or more levels of the lumbar spine

Autologous bone and/or bone marrow harvest is not feasible or is not expected to promote fusion. These patients are diabetics and smokers.

The Infuse/MASTERGRAFTTM Posterolateral Revision Device system is unproven and not medically necessary for all other indications including the following:

Known contraindications including:

o hypersensitivity to recombinant human Bone Morphogenetic Protein-2, bovine Type I collagen or to other components of the formulation

o Known active malignancy or patients undergoing treatment for a malignancy

o Pregnancy o Active infection at operative site

Planned use of grafting in the vicinity of a resected or extant tumor Skeletally immature patient (younger than 21 years of age or no

radiographic evidence of epiphyseal closure) Infuse/MASTERGRAFT Posterolateral Revision Device system has not

received FDA approval for any other indications except those indicated as proven. The safety and effectiveness of Infuse/MASTERGRAFT

Posterolateral Revision Device system has not been demonstrated for

other conditions in studies published in peer-reviewed literature. Bone Morphogenetic Protein-7 (BMP-7) OP-1 Implant and OP-1 Putty are unproven and not medically necessary for the enhancement of bone healing and/or fusion with or without use of other devices (including the PEEK device).



UPDATED



(continued)

Mar. 1, 2016

Use of BMP7 has not demonstrated accelerated healing. Available studies have been limited by substantial loss of study participants at follow-up as well as by short follow-up times. Ceramic-Based Products

Ceramic-based products such as beta tricalcium phosphate (b-TCP),

calcium phosphate, calcium sulfate and bioactive glass, used alone or in combination with other grafts including bone marrow aspirate are unproven and not medically necessary for the enhancement of bone healing and/or fusion. Only very weak conclusions about effectiveness of ceramic-based products may be drawn from studies because of small sample size, lack of control or

comparison groups in most studies. The absence of a formal assessment of clinical outcomes in most studies limits the conclusions that can be drawn about the place of b-TCP in bone healing and fusion. Furthermore, definitive patient selection criteria have not been established for the use of b-TCP bone void fillers.

Note: For additional information on ceramic-based products please see

definition section. Cell-Based Products Cell-based products such as mesenchymal stem cells (MSC), are unproven and not medically necessary for the enhancement of bone healing.

Evidence in the published scientific literature has not demonstrated an improved health outcome benefit over standard therapies. Well-designed, large randomized comparative clinical trials are needed to demonstrate the efficacy and safety of MSC therapy for orthopedic indications.

Platelet-Rich Plasma Platelet-rich plasma (e.g., autologous platelet derived growth factor)

is unproven and not medically necessary when used to enhance bone or soft tissue healing. Evidence in the published scientific literature is inconsistent and does not lend strong support to the clinical utility of using PRP to augment bone or soft tissue healing. OptiMesh®



UPDATED



(continued)

Mar. 1, 2016 The OptiMesh deployable grafting system is unproven and not medically necessary. There is insufficient evidence that the use of OptiMesh will improve structural support of the vertebrae. Further studies are needed to evaluate safety and efficacy of this grafting system.

Breast Reduction Surgery

Apr. 1, 2016

Updated supporting information; replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care

Guidelines, 20th edition, 2016” (effective Apr.1, 2016)

Indications for Coverage Criteria for a Coverage Determination as Reconstructive: Breast reduction surgery is considered reconstructive and medically necessary when the following criteria are met and a physiologic

functional impairment is identified: A. Macromastia is the primary etiology of the member’s functional

impairment or impairments (as defined in the Definition section of the policy);

The following are examples of functional impairments that must be attributable to macromastia to be considered (not an all-inclusive list):

o Severe skin excoriation/intertrigo unresponsive to medical management o Severe restriction of physical activities that meets the definition of

functional impairment o Signs and symptoms of nerve compression that are unresponsive to

medical management, e.g., ulnar paresthesias o Acquired kyphosis that is attributed to macromastia o Chronic breast pain due to weight of the breasts o Upper back, neck, or shoulder pain o Shoulder grooving from bra straps o Headache

and B. The amount of tissue to be removed plots above the 22nd percentile; or

C. If the amount of tissue to be removed plots between the 5th and 22nd percentiles, the procedure may be either reconstructive or cosmetic; the determination is based on the review of the information provided; and

D. Diagnostic tests, if done, have ruled out other causes of the functional impairment; and

E. The proposed procedure is likely to result in significant improvement of the functional impairment.

The following documentation may be requested as part of the review:



UPDATED


Breast Reduction Surgery (continued)

Apr. 1, 2016

Reduction Mammoplasty documentation should include the evaluation and management note for the date of service and the note for the day the decision to perform surgery was made. The member’s medical record must contain, and be available for review on request, the following information: Height and weight.

Body Surface Area (BSA).

Photographs that document macromastia. Coverage Limitations and Exclusions Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to member

specific benefit documents. 1. Cosmetic Procedures are excluded from coverage. Procedures that correct

an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly

does not classify surgery (or other procedures done to relieve such

consequences or behavior) as a reconstructive procedure. 2. Any procedure that does not meet the reconstructive criteria above in the

Indications for Coverage section, e.g., psychological or social reasons, breast size asymmetry unless post mastectomy, exercise.

3. Breast reduction surgery is cosmetic when done to improve appearance without improving a functional/physiologic impairment.

4. The use of liposuction as the sole procedure for breast reduction surgery is considered cosmetic.

Appendix

This Schnur chart may be used to assess whether the amount of tissue that will be removed is reasonable for the body habitus, and whether the procedure is cosmetic or reconstructive in nature.

1. If the amount plots above the 22nd percentile and the member has a functional impairment, the procedure is reconstructive.

2. If the amount plots below the 5th percentile, the procedure is cosmetic. 3. If the amount plots between the 5th and 22nd percentiles, the procedure

may be either reconstructive or cosmetic based on review of information. To calculate body surface area (BSA) see:



UPDATED


Breast Reduction Surgery (continued)

Apr. 1, 2016

http://www-users.med.cornell.edu/~spon/picu/calc/bsacalc.htm; or BSA = (W 0.425 x H 0.725) x 0.007184 (weight is in kilograms and height is

in centimeters) Modified Schnur Nomogram Chart

Tissue removed per breast (gm)

Body Surface (m2) Lower 5th percentile Lower 22nd percentile

1.35 127 199

1.40 139 218

1.45 152 238

1.50 166 260

1.55 181 284

1.60 198 310

1.65 216 338

1.70 236 370

1.75 258 404

1.80 282 441

1.85 308 482

1.90 336 527

1.95 367 575

2.00 401 628

2.05 439 687

2.10 479 750

2.15 523 819

2.20 572 895

2.25 625 978

2.30 682 1,068

2.35 745 1,167

2.40 814 1,275

2.45 890 1,393

2.50 972 1,522

2.55 1,062 1,662

http://www-users.med.cornell.edu/~spon/picu/calc/bsacalc.htm



UPDATED


Cytological Examination of Breast Fluids for Cancer Screening

Apr. 1, 2016 Updated non-coverage rationale; removed introductory statement reiterating that there is insufficient clinical evidence to support medical efficacy of

cytological examination of breast

fluids for cancer screening Updated list of applicable codes;

removed notation indicating: o Unlisted CPT codes are used

to report various services; a full description of the

requested/rendered service must be provided by the physician or other health care professional before applying the guidelines set forth by this policy

Removed “Additional Products”

information listing specific device/product names

Updated supporting information to reflect the most current clinical evidence and FDA information

Breast ductal lavage is unproven and not medically necessary for use in breast cancer screening of either low-risk or high-risk women. There is inadequate clinical evidence that breast ductal lavage either allows for better clinical decision-making or reduces breast cancer mortality. Further studies are necessary to determine the efficacy of cytological examination of

ductal fluid in detecting atypical cells to identify women at increased risk of

breast cancer as well as comparing the results to established methods of detecting and diagnosing breast cancer. Ductal lavage is intended for use in high-risk women but no definite patient selection criteria for ductal lavage of the breast have been established. The HALO® Breast Pap Test is unproven and not medically necessary

for use in breast cancer screening of either low-risk or high-risk women. There is inadequate clinical evidence that automated nipple aspiration either allows for better clinical decision-making or reduces breast cancer mortality. Further studies are necessary to determine the efficacy of cytological examination of ductal fluid in detecting atypical cells to identify women at

increased risk of breast cancer as well as comparing the results to established

methods of detecting and diagnosing breast cancer. Fiberoptic ductoscopy, with or without ductal lavage, is unproven and not medically necessary for use in breast cancer diagnosis or screening or as an intraoperative tool to guide surgery. There is insufficient clinical evidence demonstrating that fiberoptic ductoscopy

allows for better clinical decision-making, reduces breast cancer mortality or serves as a useful adjunct to or replacement of open surgical excision.

Fecal Calprotectin Testing

Mar. 1, 2016

Updated supporting information to reflect the most current

clinical evidence, FDA information and references; no change to non-coverage rationale

or list of applicable codes

Fecal measurement of calprotectin is unproven and not medically necessary for the diagnosis and management of all conditions,

including but not limited to the following: Inflammatory bowel disease (IBD) including ulcerative colitis and

Crohn's disease.

Colorectal cancer. There is insufficient evidence that fecal calprotectin is effective as a biomarker for the diagnosis and management of intestinal disease. Before fecal calprotectin can be incorporated into routine clinical practice, studies in larger and diverse groups of patients will be needed to further clarify its role in



UPDATED


Fecal Calprotectin Testing (continued)

Mar. 1, 2016 clinical decision making and its effect on the outcome of treatment of the condition for which it is being used.

Gastrointestinal

Motility Disorders,

Diagnosis and Treatment

Apr. 1, 2016

Reformatted list of applicable

CPT codes; removed descriptor

classifying codes as “reimbursable” or “non-reimbursable”

Gastric Electrical Stimulation Therapy

Gastric electrical stimulation therapy is proven and medically

necessary for the treatment of chronic, intractable (drug-refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology when used according to U.S. Food and Drug Administration (FDA) labeled indications. See the U.S. Food and Drug Administration (FDA) section of this policy for information regarding FDA labeling and Humanitarian Device Exemption (HDE) for gastric electrical

stimulation. Manometry and Rectal Sensation, Tone, and Compliance Test The following tests are proven and medically necessary for evaluating anorectal function: Rectal sensation, tone, and compliance test

Anorectal manometry

Colonic Manometry Colonic manometry is unproven and not medically necessary for evaluating colon motility. There is insufficient clinical evidence of efficacy in the published peer-reviewed medical literature for the use of colon motility testing or colonic

manometry. Patient selection criteria and the role of colonic manometry in the management of motility abnormalities such as refractory constipation must be better defined in statistically robust, well-designed clinical trials. Defecography

Defecography is proven and medically necessary for the evaluation of intractable constipation and for patients with constipation who have

one or more of the following conditions that are suspected to be the cause of impaired defecation: Pelvic floor dyssynergia (inappropriate contraction of the puborectalis

muscle) or Enterocele (e.g., after hysterectomy) or Anterior rectocele

Defecography is unproven and not medically necessary for the routine



UPDATED


Gastrointestinal Motility Disorders, Diagnosis and Treatment (continued)

Apr. 1, 2016 evaluation of constipation for conditions other than those listed above. Direct visualization is the preferred method of evaluating intractable constipation in the absence of the stated indications above.

MRI defecography is unproven and not medically necessary for the

evaluation of constipation and anorectal or pelvic floor disorders. There is insufficient clinical evidence of efficacy in the published peer-reviewed medical literature for the use of MRI defecography. The utility of this advanced imaging technology in the evaluation and management of refractory constipation must be better defined in statistically robust, well-designed clinical trials.

Electrogastrography and Electroenterography Cutaneous, mucous, or serosal electrogastrography or electroenterography is unproven and not medically necessary for diagnosing intestinal or gastric disorders including gastroparesis. There is insufficient evidence to conclude that electrogastrography or

electroenterography can accurately diagnose gastroparesis and other gastric

or intestinal disorders. There are no data to conclude that electrogastrography or electroenterography is beneficial for health outcomes in patients with gastric or intestinal disorders.

Hearing Aids and Devices Including Wearable, Bone-Anchored and

Semi-Implantable

Apr. 1, 2016

Updated benefit considerations; replaced state/plan specific guidelines with the following language:

o The following hearing aids may not be covered for certain benefit plans; refer to

the member specific benefit document to determine if coverage applies:

Wearable Hearing Aids (Including Non-Implantable Bone Conduction Hearing Aids Utilizing a Headband)

Semi-Implantable Electromagnetic Hearing

Wearable Hearing Aids (Including Non-Implantable Bone Conduction Hearing Aids Utilizing a Headband) Hearing aids required for the correction of a hearing impairment (a reduction in the ability to perceive sound which may range from slight

to complete deafness) are proven and medically necessary. Bilateral or unilateral bone-anchored hearing aids utilizing a headband (without osseointegration) are proven and medically

necessary for hearing loss in a patient who is not a candidate for an air-conduction hearing aid and when used according to U.S. Food and Drug Administration (FDA) approved indications.

Semi-Implantable Electromagnetic Hearing Aids (SEHA) A semi-implantable electromagnetic hearing aid is proven and medically necessary for sensorineural hearing loss in a patient who is not a candidate for an air-conduction hearing aid and when used according to FDA approved indications.



UPDATED


Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable

(continued)

Apr. 1, 2016

Aids (SEHA) Bone Anchored Hearing

Aids Totally Implanted Hearing

Systems

Partially Implantable Bone

Conduction Hearing Aid with Magnetic Coupling

Intraoral Bone Conduction Hearing Aids

o Frequency modulated (FM) systems can be used as an

extension or accessory of hearing aids; FM systems are excluded from coverage; these do not prevent, diagnose or treat a sickness or injury, and are not integral

to the hearing aid itself

Bone Anchored Hearing Aids Implantable Bone-Anchored Hearing Aid (BAHA) for Sensorineural Hearing Loss:

A unilateral implantable bone-anchored hearing aid is proven and medically necessary for sensorineural hearing loss in one ear in a

patient who is not a candidate for an air-conduction hearing aid and when used according to FDA approved indications. Unilateral or bilateral implantable bone-anchored hearing aids are proven and medically necessary for sensorineural hearing loss in both ears when both of the following criteria are present: The poorer ear is not a candidate for an air-conduction hearing aid due to

a speech reception threshold of 70 dB or more OR a word discrimination score of less than 60%; and

The better hearing ear has a speech reception threshold of 35 dB or less and a speech discrimination score of 60% or more.

Implantable Bone-Anchored Hearing Aid (BAHA) for Conductive or Mixed Hearing Loss:

A unilateral implantable bone-anchored hearing aid is proven and medically necessary for conductive or mixed hearing loss in one or both ears in a patient who is not a candidate for an air-conduction hearing aid and when used according to FDA approved indications. Bilateral implantable bone-anchored hearing aids are proven and

medically necessary for conductive or mixed hearing loss in both ears in a patient who is not a candidate for an air-conduction hearing aid and when used according to FDA approved indications.

Totally Implanted Hearing Systems Totally implanted hearing systems are unproven and not medically necessary for hearing loss.

There is inadequate evidence demonstrating the efficacy of totally implanted hearing systems for treating hearing loss or deafness. Well-designed studies with larger patient populations and longer follow-up are required to demonstrate the safety and benefits of these devices. Partially Implantable Bone Conduction Hearing Aid With Magnetic



UPDATED


Hearing Aids and Devices Including Wearable, Bone-Anchored and Semi-Implantable

(continued)

Apr. 1, 2016 Coupling Partially implantable magnetic bone conduction hearing devices are unproven and not medically necessary for hearing loss. There is limited evidence to support the use of partially implantable magnetic bone conduction hearing devices to treat hearing loss. The evidence

assessing the effectiveness of this device is limited to preliminary uncontrolled

studies with small populations. Additional studies with larger populations and long-term follow-up are needed to evaluate improvement of hearing with this device. Intraoral Bone Conduction Hearing Aids An intraoral bone conduction hearing aid is unproven and not

medically necessary for treating hearing loss. There is insufficient evidence to support the use of an intraoral bone conduction hearing aid to treat hearing loss. The quality of the studies was low due to small study populations, short follow-up, and lack of randomization and appropriate control groups. Future studies with larger populations of patients wearing the device for longer periods are needed to evaluate hearing

benefits and device safety.

Home Health Care

Apr. 1, 2016

Added reference link to policy titled Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies and Repairs/Replacements

Updated conditions of coverage/authorization

requirements; removed language indicating New York individual plans with out-of-network

benefits do not require precertification when services are provided out-of-network

Updated benefit considerations: o Removed language indicating

all Members have specific benefit limitations/benefit maximums determined by group and individual plans;

Requirements for Coverage The services being requested must meet all of the following: 1. Be ordered and directed by a treating practitioner or specialist (M.D., D.O.,

P.A. or N.P); and 2. The care must be delivered or supervised by a licensed professional in

order to obtain a specified medical outcome; and 3. Services must be skilled care in nature (refer to Skilled Care and Custodial

Care Services and see Definition section of the policy); and 4. Services must be intermittent and part time (typically provided for less

than 4 hours per day. Refer to member specific plan document for

intermittent definitions if provided) 5. Services are provided in the home in lieu of skilled care in another setting

(such as but not limited to a nursing facility, acute inpatient rehabilitation

or a hospital) 6. Services must be clinically appropriate and not more costly than an

alternative health services; and 7. A written treatment plan must be submitted with the request for specific

services and supplies. Periodic review of the written treatment plan may be required for continued Skilled Care needs and progress toward goals;



UPDATED


Home Health Care (continued)

Apr. 1, 2016

please refer to the Member's health benefits plan for specific limitations/maximums

o Removed product specific benefit coverage guidelines

for Healthy New York and New

Jersey Small and Individual plan members

o Added language to indicate: Before using this guideline,

please check the member specific benefit document

and any federal or state mandates, if applicable

Updated coverage rationale: o Removed content/language

outlined in policies titled Inpatient Maternity Stay and

Subsequent Home Nursing

and Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies, and Repairs/Replacements

o Updated list of applicable coverage limitations and

exclusions; added language to clarify the following services are excluded: Homemaker services

unrelated to Member's care or home meal delivery services (e.g., Meals-on-

Wheels) or transportation services (e.g., Dial-a-Ride)

Services of an independent nurse hired directly by the family/patient

Added list of applicable revenue codes: 0550, 0551, 0552, 0559,

and 8. Services are not provided for the comfort and convenience of the enrollee

or the enrollee’s family; and 9. Services are not custodial care in nature.

Additional Information:

Medical supplies and medications that are used in conjunction with a home health care visit are covered as part of that visit. Some examples are, but not limited to, surgical dressing, catheters, syringes, irrigation devices. Reimbursement for home health care visits and supplies are contractually determined.

Eligible physical, occupational and speech therapy received in the home

from a Home Health Agency is covered under the Home Health Care section of the Member’s certificate of coverage and/or summary of benefits. The Home Health Care section only applies to services that are rendered by a Home Health Agency.

Eligible physical, occupational, or speech therapy received in the home from an independent physical, occupational or speech therapist (a

therapist that is not affiliated with a Home Health Agency) is covered will

be accumulated and applied to the home care benefit, not the outpatient rehabilitation services benefit.

Laboratory services should be referred to a contracted vendor or otherwise covered per the Member's benefit package.

Hemophilia

Oxford will cover medically necessary and appropriate home treatment services for the bleeding episodes associated with hemophilia including the purchase of blood products and blood infusion equipment.

Connecticut Lines of Business and New Jersey Individual Plan Members: Assisted administration of clotting factor drugs in the home requires pre-

certification for the home care services. Precertification is not required for the clotting factor drug with the exception of Eloctate. All other clotting factor drugs do not require precertification.

Clotting factors are covered under medical benefit; refer to Drug Coverage Guidelines for coverage guidelines.

Eloctate requires precertification; refer to Eloctate for Connecticut Lines of Business and New Jersey Individual Plans for coverage guidelines.



UPDATED


Home Health Care (continued)

Apr. 1, 2016 0570, 0571, 0572, 0579, 0580, 0581, 0582, 0583, 0589, 0590, 0600 – 0604, 0609, 0640, 0641, 0642, 0644 – 0649

Updated supporting information

to reflect the most current

description of services and references

New Jersey Large and Small groups and New York Lines of Business: For coverage of assisted administration of blood products, refer to Assisted

Administration of Clotting Factors and Coagulant Blood Products. For information regarding coverage of clotting factor and coagulant blood

products, including Eloctate, refer to Clotting Factors and Coagulant Blood

Products.

Coverage Limitations and Exclusions 1. Home health care does not include Custodial Care, domiciliary care, respite

care, or rest cures and therefore these services are not covered. (Please check the Member’s certificate of coverage and/or summary of benefits).

2. Services of personal care attendants (these are not home health aides).

3. Oxford will determine if benefits are available by reviewing both the skilled nature of the service and the need for Physician-directed medical management. A service will not be determined to be "skilled" simply because there is not an available caregiver.

4. Covered pharmaceuticals, drugs, and DME provided in connection with home health services may be subject to separate benefit categories,

please reference the Member’s certificate of coverage and/or summary of

benefits. 5. Homemaker services unrelated to Member's care or home meal delivery

services (e.g., Meals-on-Wheels) or transportation services (e.g., Dial-a-Ride) are excluded.

6. Private Duty Nursing. Refer to Private Duty Nursing for additional information.

7. Services of an independent nurse hired directly by the family/patient are excluded.

8. Home Health Services beyond benefit limits, e.g., visits.

Home

Hemodialysis

Mar. 1, 2016

Updated coverage rationale;

corrected reference to the Medicare Benefit Policy Manual

Chapter 11, Section 30.2 Home Dialysis Training

Updated supporting information to reflect the most current description of services, clinical evidence, FDA information and

references

Home hemodialysis (HHD) is medically necessary as an alternative to

facility-based hemodialysis for patients with end-stage renal disease when the following criteria are met.

Patient is stable on dialysis with no evidence of complex skilled interventions being necessary during treatments

Patient or non-professional caregiver has the ability to perform and maintain home hemodialysis and has received comprehensive training regarding proper protocol

Absence of complications and significant concomitant disease that would

cause home hemodialysis to be unsafe or unsuitable



UPDATED


Home Hemodialysis (continued)

Mar. 1, 2016

Presence of well-functioning vascular access

Professional staff-assisted home hemodialysis is medically necessary as an alternative to facility- based hemodialysis for patients with end-stage renal disease who meet ALL of the following criteria:

Patient is stable on dialysis and not at increased risk as a result of having

the procedure performed outside a dialysis center venue; and Patient has well-functioning vascular access; and Patient has medical contraindications to leaving home for hemodialysis;

and Patient or non-professional caregiver is not capable of performing home

hemodialysis; and

Staff assisted home hemodialysis protocols generally match those provided in the hemodialysis center (i.e. at least 3 times per week, 3-4 hour treatments). The exact dialysis therapy employed is determined on an individual basis by the attending nephrologist

See the Medicare Benefit Policy Manual Chapter 11, Section 30.2 Home

Dialysis Training. Available at:

https://www.cms.gov/manuals/Downloads/bp102c11.pdf Accessed November 5, 2015.

Immune Globulin Site of Care Review Guidelines for Medical Necessity of Hospital

Outpatient Facility Infusion

Apr. 1, 2016

Updated supporting information; replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016”

Introduction This guideline addresses the criteria for consideration of allowing hospital outpatient facility infusion service for immune globulin (IVIG and SCIG) therapy1. This includes hospital based services with the following CMS/AMA Place of Service codes:

22 On Campus-Outpatient Hospital, and 19 Off Campus-Outpatient Hospital

Criteria and Clinical Indications for Hospital Outpatient Site of Care Selection Criteria: When requested, hospital outpatient site of care may be approved

when: Any of the clinical indications questions 1-8 below can be answered ‘yes’;

and The provider has submitted the appropriate supporting documentation. Clinical Indications: See the above criteria for the following questions.

https://www.cms.gov/manuals/Downloads/bp102c11.pdf



UPDATED



Outpatient Facility

Infusion (continued)

Apr. 1, 2016

Note: If more than one of the criteria addressed in the questions below are met, then the greatest of the applicable approval time periods will be allowed. 1. Is this the patient’s initial infusion of immune globulin or re-initiation 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 d. Home based infusion with nurse supervision e. Home based infusion without nurse supervision

3. Immune Globulin infusion is widely used throughout the various sites of care. According to a 2008 survey by the Immune Deficiency Foundation of 1,030 patients being treated with immune globulin, two out of five (42%) IVIG



UPDATED



Outpatient Facility

Infusion (continued)

Apr. 1, 2016 users reported that they usually received their infusion at 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.

Lupron-Depot / Lupron-Depot Ped (Leuprolide Acetate)

Mar. 1, 2016

Updated supporting information to reflect the most current clinical evidence; no change to coverage rationale or lists of applicable codes

Please refer to the Injectable Chemotherapy Drugs: Application of NCCN Clinical Practice Guidelines Policy for updated information based on the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium® (NCCN Compendium®) for oncology indications.

This policy refers to the following leuprolide acetate drug products: Lupron Depot

Lupron Depot-Ped Lupron Depot is proven for: Central Precocious Puberty

Additional information to support medical necessity review:

Lupron Depot is medically necessary for the treatment of central precocious puberty when all of the following criteria are met:

Diagnosis of central precocious puberty (idiopathic or neurogenic); and

Onset of secondary sexual characteristics in one of the following: o Females ≤ 8 years of age o Males ≤9 years of age

and Confirmation of diagnosis as defined by one of the following:

o Pubertal luteinizing hormone response to a GnRH stimulation test

o Bone age advanced one year beyond the chronological age The Lupron Depot label states that treatment should be discontinued at the



UPDATED


Lupron-Depot / Lupron-Depot Ped (Leuprolide Acetate) (continued)

Mar. 1, 2016

appropriate age of onset of puberty at the discretion of the physician. Give consideration to discontinuing treatment before 11 years of age in girls and 12 years of age in boys. Endometriosis

Additional information to support medical necessity review:

Lupron Depot is medically necessary for the treatment of endometriosis when both of the following criteria are met:

Diagnosis of endometriosis; and One of the following:

o Contraindication, intolerance, or failure of initial treatment with oral contraceptives and non-steroidal anti-inflammatory drugs (NSAIDs)

o Patient has had surgical ablation to prevent recurrence

The Lupron Depot label states that the duration of initial treatment or retreatment for endometriosis should be limited to 6 months. For recurrence of symptoms, leuprolide may be used in combination with

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) The recommended duration of therapy for the treatment of uterine leiomyomata is ≤ 3 months.

Fertility Preservation



UPDATED



Mar. 1, 2016

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 Management Department

Medical Benefit

Lupron Depot® 11.25 mg (3 month supply of the 3.75 mg dose)

Yes - Oxford’s Medical Management Department

Medical Benefit



UPDATED



Mar. 1, 2016

Lupron Depot® 7.5 mg No precertification required Medical Benefit

Lupron Depot 22.5® mg (3 month supply of the 7.5 mg

dose)

Lupron Depot® 30 mg (4 month supply of the 7.5 mg dose)

No precertification required Medical Benefit

Lupron® Depot Pediatric 7.5

mg Lupron® Depot Pediatric 11.25 mg Lupron® Depot Pediatric 15 mg

Yes – Oxford’s Medical

Management Department Note: Medical Director review required

Medical

Benefit

Rhinoplasty and Other Nasal

Surgeries

Rhinoplasty and

Apr. 1, 2016

Updated supporting information; replaced reference to “MCG™

Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016” (effective Apr. 1, 2016)

Some states require benefit coverage for services that UnitedHealthcare considers cosmetic procedures, such as repair of external congenital

anomalies in the absence of a functional impairment. Please refer to enrollee’s plan specific documents. Indications for Coverage Rhinoplasty for Nasal Vestibular Stenosis or Alar Collapse

Repair of nasal vestibular stenosis or alar collapse is considered reconstructive and medically necessary when all of the following criteria are present: A. Prolonged, persistent obstructed nasal breathing due to internal and/or

external nasal valve compromise (see definition), and B. Internal valve compromise due to collapse of the upper lateral cartilage

and/or external nasal valve compromise due to collapse of the alar (lower lateral) cartilage resulting in an anatomic mechanical nasal airway

obstruction that is a primary contributing factor for obstructed nasal breathing. and

C. Other causes have been eliminated as the primary cause of nasal obstruction (e.g., sinusitis, allergic rhinitis, vasomotor rhinitis, nasal polyposis, adenoid hypertrophy, nasopharyngeal masses)

Rhinoplasty for Congenital Anomalies The following are considered reconstructive and medically necessary when the following criteria are present:



UPDATED


Other Nasal Surgeries (continued)

Rhinoplasty and

Apr. 1, 2016

Rhinoplasty is considered reconstructive when performed for a nasal deformity associated with congenital craniofacial anomalies including, but not limited to Pierre Robin, Apert Syndrome, Fraser Syndrome, Binder Syndrome, Goldenhar Syndrome, Nasal dermoids, Tessier Nasal Cleft (most commonly #1) or associated with a cleft lip or cleft palate.

Septal Dermatoplasty (CPT 30620): Septal dermatoplasty is considered reconstructive when: A. There is a documented functional impairment (e.g., Obstruction, pain or

bleeding) due to diseased nasal mucosa, and B. The functional impairment will be eliminated by a skin graft.

Lysis Intranasal Synechia (CPT 30560): Lysis intranasal synechia is considered reconstructive when: A. There is a documented functional impairment (e.g., Obstruction, pain or

bleeding) due to intranasal synechia (adhesions/scar bands), and B. The functional impairment will be eliminated by lysis of the synechia.

Medical Necessity Plans: Please use the criteria above where applicable.

Documentation: Rhinoplasty or other nasal surgery documentation should include the evaluation and management note for the date of service and the note for the day the decision to perform surgery was made. The enrollee’s medical record must contain, and be available for review on request, the following

information: Physician office notes Radiologic imaging Photographs that document the nasal anomaly

Coverage Limitations and Exclusions Cosmetic Procedures are excluded from coverage, including but not limited to:

A. Procedures that correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or behavior) as a reconstructive procedure.



UPDATED


Other Nasal Surgeries (continued)

Apr. 1, 2016 B. Rhinoplasty, unless rhinoplasty criteria above are met. C. Any procedure that does not meet the reconstructive criteria above. D. Rhinoplasty procedures performed to improve appearance. (check

enrollee’s plan specific document)

Surgical and

Ablative

Procedures for Venous Insufficiency and Varicose Veins

Surgical and

Apr. 1, 2016

Apr. 1, 2016

Clarified coverage limitations and

exclusions; replaced language

indicating: o “Procedures that correct an

anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic

Procedures” with “procedures that correct an anatomical Congenital Anomaly without improving or restoring physiologic function are

considered Cosmetic Procedures and therefore

excluded from coverage” o “Endovenous ablation

(radiofrequency and/or laser) of either reticular or telangiectatic veins is not reconstructive and not medically necessary” with

“Endovenous ablation (radiofrequency and/or laser) of either reticular or

telangiectatic veins is not reconstructive and not medically necessary and

therefore excluded from coverage”

Updated coverage rationale: o Removed language indicating

service is “proven” from medically necessary

I. Varicose Vein Ablative and Stripping Procedures:

A. Radiofrequency ablation, endovenous laser ablation, stripping,

ligation and excision of the great saphenous vein and small saphenous veins are considered reconstructive medically necessary when ALL of the following criteria are present (1, 2, 3 and 4): 1. Junctional Reflux (see definition section):

a. Ablative therapy for the great or small saphenous veins will be

considered reconstructive and therefore proven and medically necessary only if junctional reflux is demonstrated in these veins; or

b. Ablative therapy for accessory veins will be considered reconstructive and proven and medically necessary only if

anatomically related persistent junctional reflux is demonstrated after the great or small saphenous veins have

been removed or ablated. 2. Member must have one of the following functional

impairments: a. Skin ulceration; or b. Documented episode(s) of frank bleeding of the varicose vein

due to erosion of /or trauma to the skin; or c. Documented superficial thrombophlebitis or documented

venous stasis dermatitis; or d. Moderate to severe pain causing functional/physical

impairment.

3. Venous Size: a. The great saphenous vein must be 5.5mm or greater when

measured at the proximal thigh immediately below the

sapheno-femoral junction via duplex ultrasonography b. The small saphenous vein or accessory veins must measure 5

mm or greater in diameter immediately below the appropriate junction.

4. Duration of reflux, in the standing or reverse Trendelenburg position that meets the following



UPDATED


Ablative Procedures for Venous Insufficiency and Varicose Veins

(continued)

Surgical and

Apr. 1, 2016

statement for: Radiofrequency ablation,

endovenous laser ablation, stripping, ligation and excision of the great

saphenous vein and small

saphenous veins Ablation of perforator veins

o Replaced references to “endomechanical ablation” with “endovenous mechanochemical ablation

(MOCA)” Updated definitions; added

definition of: o Congenital Anomaly o Cosmetic Procedures o Duplicate Saphenous Vein

Updated list of applicable CPT

codes; removed 75894 (and corresponding notation pertaining to privileging guidelines)


description of services, clinical evidence, FDA information and references

parameters: a. Greater than or equal to 500 milliseconds (ms) for the great

saphenous, small saphenous or principle tributaries b. Perforating veins > 350 ms c. Some duplex ultrasound readings will describe this as

moderate to severe reflux which will be acceptable.

B. Ablation of perforator veins is considered reconstructive medically necessary when the following criteria are present: 1. Evidence of perforator venous insufficiency measured by recent

duplex ultrasonography report (see criteria above); and 2. Perforator vein size is 3.5mm or greater; and 3. Perforating vein lies beneath a healed or active venous stasis

ulcer. C. Endovenous mechanochemical ablation (MOCA) of varicose

veins using a percutaneous infusion catheter is unproven and not medically necessary for treating venous reflux. There is insufficient evidence in the clinical literature supporting the safety and efficacy of MOCA for treating varicose veins. Further

results from large, well-designed studies are needed to support the

clinical utility of this approach. II. Ligation Procedures:

A. Ligation of the great saphenous vein at the saphenofemoral junction, as a stand-alone procedure, is unproven and not medically necessary for treating venous reflux.

Ligation performed without stripping or ablation is associated with high long-term recurrence rates due to neovascularization.

B. Ligation of the small saphenous vein at the saphenopopliteal junction, as a stand-alone procedure, is unproven and not

medically necessary for treating venous reflux. Ligation performed without stripping or ablation is associated with high long-term recurrence rates due to neovascularization.

C. Ligation at the saphenofemoral junction, as a stand-alone procedure, is proven and medically necessary, when used to prevent the propagation of an active clot to the deep venous system in patients with ascending superficial thrombophlebitis who fail or are intolerant of anticoagulation therapy.

D. Ligation at the saphenofemoral junction, as an adjunct to radiofrequency ablation or endovenous laser ablation of the



UPDATED


Ablative Procedures for Venous Insufficiency and Varicose Veins

(continued)

main saphenous veins, is unproven and not medically necessary for treating venous reflux. Published clinical evidence has not demonstrated that the addition of saphenofemoral ligation to endovenous ablation procedures provides an additive benefit in resolving venous reflux or preventing varicose

vein recurrence. Endovenous ablation is a clinically effective therapy

for treating venous reflux. Adding ligation to the procedure adds clinical risk without adding clinical benefit.

Synagis (Palivizumab)

Synagis

Apr. 1, 2016

Apr. 1, 2016

Updated coverage rationale; modified list of situations in which Synagis is unproven/not medically necessary:

o Replaced “children in the second year of life (>12 months of age) unless otherwise indicated as medically necessary” with

“children in the second year of life unless otherwise indicated

as medically necessary”

Synagis (palivizumab) is proven and medically necessary to prevent serious respiratory syncytial virus disease (RSV) in high risk infants and young children when all of the following are met: 1. Administered during RSV season as defined by Centers for Disease and

Prevention (CDC) surveillance reports (http://www.cdc.gov/surveillance/nrevss/rsv/) or state or local health departments to confirm the start of the respiratory syncytial virus (RSV) “season”; and

2. Monthly doses of Synagis does not exceed 15 mg/kg per dose; and

3. Monthly dose of Synagis does not exceed 5 doses per single RSV “season” o Infants in a neonatal intensive care unit who qualify for prophylaxis

may receive the first dose 48 to 72 hours before discharge to home or promptly after discharge. If the first dose is administered in the hospital, this dose will be considered the first dose of the maximum 5 dose series for the season. And any subsequent doses received in the hospital setting, are also considered as part of the maximum 5 dose series. For infants born during the RSV “season,” fewer than 5 monthly doses will be needed.

and 4. One of the following clinical situations:

a. Prematurity

Infants born before 29 weeks, 0 day’s gestations who are < 12 months of age at the start of RSV “season.”

b. Chronic Lung Disease (CLD)

Age 0 to <12 months: Prophylaxis may be considered during the RSV “season” during the first year of life for preterm infants who develop chronic lung disease (CLD) of prematurity defined as gestational age <32 weeks, 0 days and a requirement for >21% oxygen for at least the first 28 days after birth.

Age ≥12 to <24 months: Palivizumab is medically necessary for

http://www.cdc.gov/surveillance/nrevss/rsv/



UPDATED


(Palivizumab) (continued)

Synagis

Apr. 1, 2016

use in pre-term infants born at < 32 weeks, 0 day’s gestation who are ≥ 12 to < 24 months of age who required at least 28 days of oxygen after birth and who continue to require supplemental oxygen, diuretics, and chronic systemic corticosteroid therapy, within 6 months of the start of the second RSV season.

c. Congenital Heart Disease (CHD)

Age 0 to < 12 months: Infants and children with hemodynamically significant CHD who are born within 12 months of onset of RSV “season” and who will most likely benefit from immunoprophylaxis include: - Infants and children with acyanotic heart disease who are

receiving medication to control congestive heart failure and will

require cardiac surgical procedures. - Infants and children with moderate to severe pulmonary

hypertension. - Documentation that decisions regarding Synagis prophylaxis for

infants with cyanotic heart defects in the first year of life were made in consultation with a pediatric cardiologist.

Age < 24 months: A postoperative dose for children who still

require prophylaxis and who have undergone surgical procedures that use cardiopulmonary bypass should be administered Synagis prophylaxis after cardiac bypass or at the conclusion of extracorporeal membrane oxygenation. - Children who undergo cardiac transplantation during the RSV

season may be considered for Synagis prophylaxis.

d. Congenital abnormalities of the airway or neuromuscular disease Age 0 to < 12 months: Infants and children with neuromuscular

disease or congenital anomaly that impairs the ability to clear

secretions from the lower airway because of ineffective cough may be considered for prophylaxis during the first year of life.

e. Immunocompromised children younger than 24 months of age

Synagis may be administered when used for prophylaxis in children who are receiving cancer chemotherapy or are severely immunocompromised although the efficacy of prophylaxis in this population is unknown (e.g., children who are receiving chemotherapy or undergo hematopoietic stem cell transplantation or solid organ transplantation).

f. Cystic fibrosis (CF) with other qualifying indications



UPDATED



Synagis

Apr. 1, 2016

Age 0 to < 12 months: Infants and children with cystic fibrosis with clinical evidence of CLD and/ or nutritional compromise in the first year of life may be considered for prophylaxis. - Failure to thrive defined as weight for length less than the 10th

percentile on a pediatric growth chart.

Age ≥ 12 to < 24 months: Continued use of Synagis prophylaxis

in the second year may be considered for infants and children with manifestations of severe lung disease including: - Previous hospitalization for pulmonary exacerbation in the first

year of life. - Abnormalities on chest radiography or chest computed

tomography that persist when stable.

- Weight for length less than the 10th percentile on a pediatric growth chart.

Synagis is unproven and not medically necessary for the following situations: 1. Infants with chronic lung disease (CLD) who do not continue to require

medical support in the second year of life.

2. Infants and children with hemodynamically insignificant heart disease (e.g., secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus).

3. Infants with cardiac lesions adequately corrected by surgery, unless they continue to require medication for congestive heart failure.

4. Infants with cardiomyopathy sufficiently mild that they do not require pharmacotherapy.

5. Children in the second year of life unless otherwise indicated under medically necessary as noted above.

6. Routine use of prophylaxis in children with Down syndrome [unless qualifying heart disease, CLD, airway clearance issues (the in the ability to clear secretions from the upper airway because of ineffective cough, or

prematurity (<29 weeks, 0 day’s gestation) is present]. 7. Routine use of prophylaxis in children with cystic fibrosis (unless

indications noted in medically necessary indications above are present). 8. Administration of monthly Synagis prophylaxis after an infant or child has

experienced a breakthrough RSV hospitalization during the current season if child had met criteria for palivizumab.

9. Prophylaxis for primary asthma prevention or to reduce subsequent



UPDATED



Synagis

Apr. 1, 2016

episodes of wheezing in infants and children. 10. Synagis prophylaxis for prevention of nosocomial disease. 11. When Synagis prophylaxis is administered in any of the following

scenarios: a. Outside of the RSV “season”

b. in doses greater than needed to provide protection in the RSV

“season” c. in excess of 5 doses per single RSV “season” d. to persons other than those at defined high risk, as specified above

12. Treatment of symptomatic RSV disease. Additional Information

In most of North America, peak RSV activity typically occurs between November and March, usually beginning in November or December, peaking in January or February, and ending by the end of March or sometime in April. Communities in the southern United States, particularly some communities in the state of Florida, tend to experience the earliest onset of RSV. Data from the Centers for Disease Control and Prevention (CDC) have identified

variations in the onset and offset of the RSV “season” in the state of Florida

that could affect the timing of Synagis administration. Despite varied onsets, the RSV “season” is of the same duration (5

months) in the different regions of Florida. On the basis of the epidemiology of RSV in Alaska, particularly in remote

regions where the burden of RSV disease is significantly greater than the general US population, the selection of Alaska Native infants eligible for

prophylaxis may differ from the remainder of the United States. Clinicians may wish to use RSV surveillance data generated by the state of Alaska to assist in determining onset and end of the RSV season for qualifying infants.

Limited information is available concerning the burden of RSV disease among American Indian populations. However, special consideration may be prudent for Navajo and White Mountain Apache infants in the first year

of life. For analysis of National Respiratory and Enteric Virus Surveillance System

(NREVSS) reports in the CDC Morbidity and Mortality Weekly Report, season onset is defined as the first of 2 consecutive weeks during which the mean percentage of specimens testing positive for RSV antigen is ≥ 10% and RSV “season” offset is defined as the last of 2 consecutive weeks during which the mean percentage of positive specimens is ≥ 10%. Use of



UPDATED



specimens to determine the start of the RSV “season” requires that the number of specimens tested be statistically significant.

Total Artificial Disc

Replacement for Spine

Total Artificial Disc

Apr. 1, 2016

Apr. 1, 2016

Reorganized coverage rationale

Removed “Additional Products” information listing specific

lumbar and cervical device/product names

Updated supporting information to reflect the most current clinical evidence, FDA

information and references

Cervical artificial total disc replacement of FDA-approved prosthesis

for degenerative cervical disc disease with symptomatic intractable radiculopathy and/or myelopathy is proven and medically necessary

in a skeletally mature individual when at least one of the following criteria is met: herniated disc osteophyte formation

And both of the following: documented patient history of neck and/or arm pain and/or a

functional/neurological deficit associated with the cervical level to be treated

failed at least six weeks of non-operative treatment prior to implantation (only applicable for elective surgery; emergent surgery, or does not

require prior non-operative treatment) Cervical artificial disc replacement is proven and medically necessary for treatment of persons with symptoms of degenerative disc disease at one level even if they have radiological evidence of degenerative disc disease at multiple levels. Radiologic evidence of degenerative disc disease is common in persons who are middle aged and older and does not

necessarily correlate with clinical symptoms. Cervical artificial total disc replacement is proven and medically necessary for the treatment of symptomatic contiguous two level degenerative disc disease in skeletally mature patients when used

according to U.S. Food and Drug Administration (FDA) labeled indications.(Note: not all cervical artificial discs have FDA labeling for

contiguous two level degenerative disc disease. Only cervical artificial discs FDA labeled for contiguous two-level disease are proven and medically necessary for this indication. Refer to the FDA section of the policy.) Cervical artificial disc replacement at one level combined with cervical spinal fusion surgery at another level (adjacent or non-adjacent)

performed at the same surgical setting is unproven and not medically necessary. This is commonly referred to as a hybrid surgery. There is



UPDATED


Replacement for Spine (continued)

insufficient published clinical evidence in peer-reviewed medical literature demonstrating the safety and efficacy of combination cervical spine surgery at multiple adjacent or non-adjacent levels. Lumbar artificial total disc replacement is unproven and not medically

necessary for the treatment of single or multiple level degenerative

disc disease in skeletally mature patients. The long-term clinical outcome of lumbar disc replacement is unclear. The evidence from uncontrolled long-term studies suggests that potential degeneration of adjacent discs and facets and wear of the polyethylene part of the disc may occur and that, in some cases, revision surgery may be needed.

Transcranial

Magnetic Stimulation

Transcranial

Mar. 1, 2016

Mar. 1, 2016

Updated reference links to

related policies Updated non-coverage rationale;

modified language pertaining to coverage guidelines for treatment of behavioral

disorders: o Added reference link to the

Optum Behavioral Solutions Coverage Determination Guideline titled Transcranial Magnetic Stimulation (TMS)

o Removed reference link to the Optum Behavioral Solutions Technology Assessments

titled NeuroStar Transcranial Magnetic Stimulation Therapy for Major Depression and

Brainsway Deep TMS for Major Depression


to reflect the most current clinical evidence, FDA information and references

Transcranial magnetic stimulation is unproven and not medically

necessary for treating all conditions including the following: Chronic neuropathic pain Dystonia Epilepsy Headaches

Parkinson's disease Stroke

Tinnitus For behavioral disorders, refer to the Optum Behavioral Solutions Coverage Determination Guideline titled Transcranial Magnetic Stimulation (TMS) at Optum Provider Express > Clinical Resources > Guidelines/Policies/Manuals > Coverage Determination Guidelines.

Some studies have examined the use of transcranial magnetic stimulation for treating disorders such as pain, dystonia, epilepsy, headaches, Parkinson’s disease, stroke, and tinnitus. However, because of limited studies and small

sample size there is insufficient data to conclude that transcranial magnetic stimulation is beneficial for treating these conditions.

Navigated transcranial magnetic stimulation (nTMS) is unproven and not medically necessary for treatment planning or for diagnosing motor neuron diseases or neurological disorders. There is limited information from the peer-reviewed published medical literature to conclude that navigated transcranial magnetic stimulation is an effective clinical diagnostic test. Most published studies involve a small



UPDATED


Magnetic Stimulation (continued)

number of patients. Randomized controlled trials with large populations are needed to evaluate how this test can reduce clinical diagnostic uncertainty or impact treatment planning.

Visual Information Processing

Evaluation and Orthoptic and Vision Therapy

Visual Information

Mar. 1, 2016

Mar. 1, 2016

Updated list of applicable CPT codes; removed coding

clarification language indicating CPT code 96111 should not be used to code visual information processing evaluations


to reflect the most current clinical evidence

Occlusion therapy is proven and medically necessary for the treatment for amblyopia (lazy eye).

Prism adaptation therapy is proven and medically necessary for the treatment of esotropia (a form of strabismus when the eye deviates inward).

Orthoptic or vision therapy is proven and medically necessary for the treatment of convergence insufficiency (ability of eyes to fix on the same point).

Orthoptic or vision therapy is unproven and not medically necessary for the treatment of the following: Exotropia (Eye Deviates Outward) Without Convergence Insufficiency Nystagmus (Involuntary Movement Of The Eyeballs)

Convergence Excess (Esotropia Is Greater For Near Vision Than For Far Vision)

Divergence Insufficiency Divergence Excess Stroke or traumatic brain injury with visuospatial deficit, hemispatial

neglect, or visual loss The available data supporting the use of vision therapy for these indications is weak and inconclusive, and derived primarily from uncontrolled or poorly

controlled studies with significant methodological flaws. The use of visual information processing evaluations to diagnose

reading or learning disabilities is unproven and not medically necessary. There is inadequate clinical evidence to support the use of visual information

processing evaluations for diagnosing reading or learning-related disabilities. Additional well-designed studies with larger sample sizes are needed to establish the diagnostic utility of this procedure. Orthoptic or vision therapy including colored lenses, filters, and overlays is unproven and not medically necessary for the treatment of



UPDATED


Processing Evaluation and Orthoptic and Vision Therapy (continued)

dyslexia and other learning and reading disabilities. There is a lack of robust data available on the efficacy of orthoptic therapy for treating dyslexia and other reading and learning disabilities. Several small randomized controlled trials of vision therapy have been published, but these studies were flawed by design limitations (including small sample size and

poorly defined patient selection criteria). The American Academy of Pediatrics

has published a statement that concludes that vision therapy is ineffective for the treatment of learning and reading problems. Visual perceptual therapy is unproven and not medically necessary for any type of learning disability or language disorder, including developmental delay.

The available data supporting the use of visual perceptual therapy to treat learning or developmental disabilities is weak and inconclusive, and derived primarily from uncontrolled or poorly controlled studies with significant methodological flaws. Vision restoration therapy is unproven and not medically necessary as

a treatment for visual field deficits following stroke or neurotrauma.

There is inadequate evidence of efficacy for this treatment. The number of participants in the few available published studies is small and follow-up time is short.

REVISED


Abnormal Uterine Bleeding and

Uterine Fibroids

Abnormal Uterine

Apr. 1, 2016

Apr. 1, 2016

Updated conditions of coverage; added language to indicate:

o Precertification is required for services covered under

the member's general benefits package when performed in the office of a participating provider

o For Commercial plans,

precertification is not required, but is encouraged, for out-of-network services performed in the office that

Levonorgestrel-Releasing Intrauterine Device The Mirena© (52 mg) levonorgestrel-releasing intrauterine device

(LNG-IUD) is proven and medically necessary for treating menorrhagia in premenopausal women.

The Skyla® (13.5 mg) LNG-IUD is unproven and not medically necessary for treating menorrhagia. There is insufficient clinical evidence in the published peer-reviewed medical literature demonstrating the safety and/or efficacy of this device for treating menorrhagia.

See the FDA section of this policy for additional information. Uterine Fibroids



REVISED


Bleeding and Uterine Fibroids (continued)

are covered under the member's general benefits package

o If precertification is not obtained, Oxford may review

for medical necessity after

the service is rendered Revised coverage rationale:

o Replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines,

20th edition, 2016” (effective 04/01/16); refer to 20th edition for complete details on applicable updates to the MCG™ Care Guidelines

Reorganized list of applicable

CPT/HCPCS codes; removed

language denoting codes requiring Medical Director review

Uterine artery embolization (UAE) is proven and medically necessary for treating symptomatic uterine fibroids for women who do NOT wish to preserve their childbearing potential. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, 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 this 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 relative to other treatment options for uterine fibroids.

Transcervical ultrasound-guided radiofrequency ablation is investigational, unproven and not medically necessary for treating 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.



REVISED


Attended Polysomnography for Evaluation of Sleep Disorders

Apr. 1, 2016

Updated conditions of coverage/special considerations; added language to indicate: o Precertification is required

for services covered under

the member's general

benefits package when performed in the office of a participating provider

o For commercial plans, precertification is not required, but is encouraged,

for out-of-network services performed in the office that are covered under the member's general benefits package

o If precertification is not

obtained, Oxford may review

for medical necessity after the service is rendered

Revised coverage rationale; replaced references to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care

Guidelines, 20th edition, 2016” (effective Apr.1, 2016)

I. Attended full-channel nocturnal polysomnography (NPSG)/laboratory sleep test (LST), performed in a healthcare facility is medically necessary in patients with suspected OSA and one (1) or more of the following indications: A. Significant chronic pulmonary disease as defined by a forced

expiratory volume (FEV1) % predicted of <60 (Pellegrino et al., 2005)

B. Progressive neuromuscular disease/neurodegenerative disorder [examples include, but are not limited to, Parkinson’s disease, myotonic dystrophy, amyotrophic lateral sclerosis, multiple sclerosis with associated pulmonary disease, history of stroke with persistent neurological sequelae]

C. Moderate to severe pulmonary hypertension (>40 mmHg) (McLaughlin

et al., 2009) D. Moderate to severe cardiac disease [examples include, but are not

limited to, congestive heart failure (New York Heart Association class III or IV), uncontrolled cardiac tachyarrhythmia (>100 beats per minute) or bradyarrhythmia (<60 beats per minute)]

E. Body mass index (BMI) >50 (DeMaria et al., 2007; Blackstone and

Cortés, 2010)

F. Obesity Hypoventilation Syndrome (OHS) G. Documented ongoing epileptic seizures in the presence of symptoms

of sleep disorder II. Attended full-channel nocturnal polysomnography

(NPSG)/laboratory sleep test (LST), performed in a healthcare

facility is medically necessary in patients without suspected OSA and one (1) or more of the following indications: A. Severe chronic periodic limb movement disorder (PLMD) (not leg

movements associated with another disorder such as sleep disordered

breathing) B. Restless leg syndrome (RLS)/Willis-Ekbom disease syndrome that has

not responded to treatment

C. Parasomnia with documented disruptive, violent or potentially injurious sleep behavior suspicious of rapid eye movement (REM) sleep behavior disorder (RBD)

D. Narcolepsy, once other causes of excessive sleepiness have been ruled out

E. History of central sleep apnea F. Patient is a child or adolescent (i.e. <18 years of age)



REVISED


Attended Polysomnography for Evaluation of Sleep Disorders (continued)

Apr. 1, 2016

G. Results of previous home sleep test (HST) were either: 1. Indeterminate for suspected OSA or upper airway resistance

syndrome; or 2. Documented as technically inadequate after 2-3 attempts/nights;

or

3. Documented as patient’s lack of mobility or dexterity to use HST

equipment safely at home; or 4. Cognitive impairment such that the patient is unable to perform a

home sleep study III. Attended full-channel nocturnal polysomnography

(NPSG)/laboratory sleep test (LST), performed in a healthcare

facility is not medically necessary for the evaluation of sleep disorders for any of the following indications: A. Significant chronic lung disease in the absence of symptoms of sleep

disorder B. Circadian rhythm disorders C. Positive airway pressure (PAP) evaluation in patients whose symptoms

continue to resolve with PAP treatment

D. Depression E. Insomnia

There is insufficient published clinical evidence that evaluation of the above disorders with polysomnography (PSG) in the absence of symptoms of sleep disorder leads to better health outcomes.

IV. An abbreviated daytime sleep study (PAP-Nap), to acclimate

patients to positive airway pressure (PAP) and its delivery, is not medically necessary.

Further results from large, prospective studies are needed to assess the clinical value of this test.

V. Actigraphy is not medically necessary for the evaluation of sleep related breathing and circadian rhythm disorders. A review of the evidence does not establish the effectiveness of actigraphy as a stand-alone tool for the diagnosis of OSA. In addition, definitive patient selection criteria for the use of actigraphy devices for the diagnosis of sleep apnea have not been established. The evidence regarding the use of actigraphy for the evaluation of circadian rhythm



REVISED



Apr. 1, 2016

disorders is of low quality; therefore, the clinical utility cannot be established.

VI. Multiple sleep latency testing (MSLT) is medically necessary for suspected narcolepsy. For information regarding medical necessity

review, when applicable, see MCGTM Care Guidelines, 20th edition, 2016,

Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC).

VII. Maintenance of wakefulness testing (MWT) is medically necessary

for the assessment of individuals in whom the inability to remain awake constitutes a safety issue, or the assessment of response to

treatment with medications in patients with narcolepsy or idiopathic hypersomnia. For information regarding medical necessity review, when applicable, see MCGTM Care Guidelines, 20th edition, 2016, Multiple Sleep Latency Test (MSLT) and Maintenance of Wakefulness Test (MWT), A-0146 (AC).

VIII. Multiple sleep latency testing (MSLT) and the maintenance of

wakefulness test (MWT) are not medically necessary for the evaluation and diagnosis of OSA.

Available published evidence is insufficient to demonstrate improved management of OSA through the use of MSLT. Published evidence for OSA is limited to poorly controlled studies.

IX. A split-night study with positive airway pressure (PAP) titration performed in an attended sleep laboratory is medically necessary when ALL of the following criteria are met: A. Patient meets the criteria for attended full-channel nocturnal

polysomnography (NPSG) B. An OSA diagnosis can be made during ≥ 2 hours of recorded sleep C. Adequate time remains for PAP titration (≥3 hours)

X. A full-night study with positive airway pressure (PAP) titration

performed in an attended sleep laboratory is medically necessary in patients who have met the criteria for attended full-channel nocturnal polysomnography (NPSG) studies and with confirmed OSA, as determined by either of the following: A. In patients where the split-night was not feasible, as determined by:



REVISED



Apr. 1, 2016

1. Apnea-hypopnea index (AHI) in the first two hours of testing was less than 20 per hour; or

2. The PAP titration portion of the original study was insufficient;

- Leaving inadequate time for PAP titration ; or

- Failing to effectively minimize respiratory events or

B. Follow-up titration in patients with persistent or new symptoms despite documented current PAP treatment.

Repeat Testing It may be necessary to perform repeat sleep studies. Where repeat testing is indicated, attended full-channel nocturnal polysomnography (NPSG)/laboratory sleep test (LST) performed in an attended sleep laboratory

is medically necessary for persons who meet criteria for attended LST above. Where unattended portable monitoring/HST are indicated, an auto-titrating continuous positive airway pressure (APAP) device is an option to determine a fixed PAP pressure. Repeat testing and repositioning/adjustments for oral

sleep appliances can be done in the home unless the patient meets criteria for an attended laboratory sleep study.

Bariatric Surgery

Apr. 1, 2016

Revised coverage rationale:

o Removed language/reference links pertaining to related policies

o Removed language outlining documentation requirements for Medical Director Review

The following bariatric surgical procedures are proven and medically

necessary in adults for the treatment of clinically severe obesity as defined by the National Heart Lung and Blood Institute (NHLBI): Gastric bypass (Roux-en-Y; gastrojejunal anastomosis) Adjustable gastric banding (laparoscopic adjustable silicone gastric

banding) – See FDA section/information 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:



REVISED


Bariatric Surgery (continued)

Apr. 1, 2016

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 pharmacotherapy); or

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 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.



REVISED



Apr. 1, 2016

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.

Bariatric surgery to treat gynecological abnormalities, osteoarthritis,

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. 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



REVISED



Apr. 1, 2016 procedures as a treatment option for obesity. 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.

Botulinum Toxins A and B

Apr. 1, 2016

Revised coverage rationale: o Updated medical necessity

criteria for use of Dysport for treatment of achalasia; added criterion requiring other causes of

dysphagia (e.g., peptic stricture, carcinoma, extrinsic compression) ruled out by upper gastrointestinal endoscopy

o Updated medical necessity criteria for use of Botox for

treatment of chronic migraine and overactive bladder; Replaced references to

“Botox” with generic drug name “OnabotulinumtoxinA”

Updated supporting information; replaced references to “MCG™ Care Guidelines, 19th

edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016”

Refer to the policy for complete details on the coverage guidelines for Botulinum Toxins A and B.

Clotting Factors and Coagulant Blood Products

Apr. 1, 2016

Revised coverage rationale: o Updated coverage guidelines

for Factor XIII (plasma-

derived) [Corifact] to indicate both of the following

Refer to the policy for complete details on the coverage guidelines for Clotting Factors and Coagulant Blood Products.



REVISED


Clotting Factors and Coagulant Blood Products (continued)

Apr. 1, 2016

criteria must be met: Diagnosis of congenital

Factor XIII deficiency; and

One of the following:

- Routine prophylactic

treatment; or - Peri-operative

management of surgical bleeding; or

- Treatment of bleeding episodes

o Updated coverage guidelines for Coagulation Factor XIII A-subunit (recombinant) [Tretten] to indicate both of the following criteria must be

met:

Diagnosis of congenital factor XIII A-subunit deficiency; and

One of the following: - Used for routine

prophylactic treatment

for bleeding; or - Treatment of bleeding

episodes o Updated coverage guidelines

for Fibrinogen Concentrate

(plasma-derived)

[RiaSTAP] to indicate both of the following criteria must be met: Diagnosis of congenital

fibrinogen deficiency, including afibrinogenemia

and hypofibrinogenemia; and



REVISED


Clotting Factors and Coagulant Blood Products (continued)

Apr. 1, 2016

One of the following: - Treatment of acute

bleeding episode; or - Prevention of bleeding

in surgical

interventions (i.e.,

surgical prophylaxis); or

Routine prophylaxis to prevent or reduce the frequency of bleeding episodes

Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes

Apr. 1, 2016

Updated conditions of coverage; added language to indicate: o Precertification is required

for services covered under the member's general


o For commercial plans, precertification is not required, but is encouraged, for out-of-network services

performed in the office that are covered under the member's general benefits package

o If precertification is not

obtained, Oxford may review for medical necessity after

the service is rendered Revised coverage rationale:

o Replaced references to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines,

20th edition, 2016” (effective Apr. 1, 2016); refer to 20th

Insulin Delivery External insulin pumps that deliver insulin by continuous subcutaneous infusion are proven and medically necessary for the following: Patients with type 1 diabetes

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Insulin Infusion Pump ACG: A-0339 (AC).

Patients with type 2 diabetes who currently perform ≥4 insulin injections and ≥4 blood glucose measurements daily.

Note: Programmable disposable external insulin pumps are considered

equivalent to standard insulin pumps. Nonprogrammable transdermal insulin delivery systems are unproven and not medically necessary for treating patients with diabetes. There is insufficient evidence in the clinical literature demonstrating the safety and

efficacy of transdermal insulin delivery in the management of patients with diabetes.

Implantable insulin pumps are investigational, unproven and not medically necessary. No implantable insulin pumps have received U.S. Food and Drug Administration (FDA) approval at this time. While some preliminary studies reported improved glycemic control and fewer episodes of hypoglycemia in

carefully selected patients, complications such as catheter blockage and infection were observed. Larger, randomized controlled trials are needed to



REVISED


Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes (continued)

Apr. 1, 2016

edition for complete details on applicable updates to the MCG™ Care Guidelines

determine the long-term impact of implantable insulin pumps on diabetes management. Insulin infuser ports are unproven and not medically necessary for insulin delivery in patients with diabetes. There is insufficient evidence

demonstrating that the use of insulin infuser ports results in improved

glycemic control beyond what can be achieved by using standard insulin delivery methods. In addition, an increase in complications, such as infection at the port site, has been reported when using these devices. Further well-designed, large-scale randomized controlled trials are needed to establish the safety and efficacy of these devices.

See the Description of Services section of this policy for further details on the various types of insulin delivery systems. Continuous Glucose Monitors with or without Combined Insulin Pumps Short-term (3-7 days) continuous glucose monitoring by a healthcare provider for diagnostic purposes is proven and medically necessary for

patients with diabetes.

Long-term continuous glucose monitoring is proven and medically necessary as a supplement to self-monitoring of blood glucose (SMBG) for patients with type 1 diabetes who meet EITHER of the following criteria AND have demonstrated adherence to a physician ordered diabetic treatment plan:

Have been unable to achieve optimum glycemic control as defined by the most current version of the American Diabetes Association (ADA) Standards of Medical Care in Diabetes; or

Have experienced hypoglycemia unawareness and/or frequent episodes of

hypoglycemia For information regarding medical necessity review, when applicable, see

MCG™ Care Guidelines, 20th edition, 2016, Continuous Glucose Monitoring ACG: A-0126 (AC). Long-term continuous glucose monitoring is unproven and not medically necessary for patients with type 2 diabetes or gestational diabetes. There is insufficient evidence that the use of long-term continuous glucose monitoring leads to improvement of glycemic control in patients with



REVISED


Continuous Glucose Monitoring and Insulin Delivery for Managing Diabetes (continued)

Apr. 1, 2016 type 2 or gestational diabetes. Remote Glucose Monitoring Remote glucose monitoring is unproven and not medically necessary for managing patients with diabetes. There is insufficient evidence in the

clinical literature to conclude that remote glucose monitoring demonstrates

improvement in clinical outcomes.

Cosmetic and Reconstructive Procedures

Apr. 1, 2016

Revised coverage rationale: o Updated indications for

coverage; added language to indicate: 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; refer to the member specific benefit document

o Revised language pertaining to coverage limitations and exclusions to indicate: Cosmetic procedures are

excluded from coverage

- Procedures that correct

an anatomical

congenital anomaly without improving or restoring physiologic function are considered cosmetic procedures

- The fact that a covered

person may suffer psychological consequences or

Indications for Coverage 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. Refer to the member specific benefit document.

Criteria for a procedure to be considered as reconstructive and medically necessary: 1. There is documentation that the physical abnormality and/or physiological

abnormality is causing a functional impairment (as defined in the

Definitions section of this policy) that requires correction. 2. The proposed treatment is of proven efficacy; and is deemed likely to

significantly improve or restore the patient’s physiological function. Coverage 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.

1. Cosmetic Procedures are excluded from coverage. Procedures that correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a

Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve such consequences or

behavior) as a reconstructive procedure. 2. Any procedure that does not meet the reconstructive criteria above in the

Indications for Coverage section.



REVISED


Cosmetic and Reconstructive Procedures (continued)

Apr. 1, 2016 socially avoidant behavior as a result of an injury, sickness or congenital anomaly does not classify

surgery (or other

procedures done to relieve such consequences or behavior) as a reconstructive procedure

Any procedure that does not meet the reconstructive criteria in the indications for Coverage section of the policy is excluded from

coverage

Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Apr. 1, 2016 Revised list of medications requiring precertification through the pharmacy benefit manager (PBM): o Added Dyanavel XR and

Imatinib (generic Gleevec) o Removed Entresto, Finacea

15% Foam, Histex-AC Syrup, Keveyis, Rexulti and Sotylize

Refer to the policy for complete details on Drug Coverage Criteria - New and Therapeutic Equivalent Medications.

REVISED

Policy Title Effective Date Drug/Medication Status Summary of Changes

Drug Coverage Guidelines

Feb. 3, 2016

Entresto (Valsartan – Sacubitril)

Revised

Removed/replaced Prior Authorization/Notification Guidelines: Entestro (Valsartan-Sacubitril)

Revised coverage criteria for initial therapy (see Prior Authorization/Medical Necessity Guidelines: Entestro (valsartan-sacubitril)); added new/additional criterion requiring: o One of the following:

Patient is receiving concomitant therapy with one of the following



REVISED


Drug Coverage Guidelines (continued)

Feb. 3, 2016 Entresto (Valsartan – Sacubitril) (continued)

Revised betablockers:

- bisoprolol

- carvedilol

- metoprolol succinate

Patient has a contraindication or intolerance to beta-blocker therapy and

o Patient does not have a history of angioedema associated with use of the following: Angiotensin converting enzyme (ACE) Inhibitor therapy Angiotensin receptor blocker (ARB) therapy

and o Patient will discontinue any use of concomitant ACE Inhibitor or ARB

before initiating treatment with Entresto. ACE inhibitors must be discontinued at least 36 hours prior to initiation of Entresto; and

o Patient is not concomitantly on aliskiren therapy


Mar. 15, 2016

Zepatier (Elbasvir/ Grazoprevir)

New

Added coverage criteria/precertification requirements to indicate precertification is required through the Pharmacy Benefit Manager (PBM)

Added prior authorization/medical necessity guidelines to indicate Zepatier will be approved for the following indications when noted criteria is met (see Prior Authorization/Medical Necessity Guidelines: Zepatier for complete details on applicable coverage criteria): o Treatment of chronic hepatitis C genotype 1a infection in treatment-

naïve, PegIFN/RBV-experienced or PegIFN/RBV/protease inhibitor-experienced patients without baseline NS5A polymorphisms

o Treatment of chronic hepatitis C genotype 1a infection in treatment-naïve, PegIFN/RBV-experienced, or PegIFN/RBV/protease inhibitor-experienced patients with baseline NS5A polymorphisms

o Treatment of chronic hepatitis C genotype 1b infection in treatment-naïve, PegIFN/RBV-experienced or PegIFN/RBV/protease inhibitor-

experienced patients o Treatment of chronic hepatitis C genotype 4 infection in treatment-

naïve patients Treatment of chronic hepatitis C genotype 4 infection in PegIFN/RBV-

experienced patients


Apr. 1, 2016

Adempas (Riociguat)

Revised

Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Adempas): o Revised reauthorization guidelines for the treatment of chronic

thromboembolic pulmonary hypertension (CTEPH); changed

https://www.unitedhealthcareonline.com/ccmcontent/ProviderII/UHC/en-US/Assets/ProviderStaticFiles/ProviderStaticFilesPdf/Tools%20and%20Resources/Pharmacy%20Resources/Clinical%20Programs/PA_Med_Nec_Entresto.pdf



REVISED



Apr. 1, 2016 Adempas (Riociguat) (continued)

Revised authorization approval timeframe from “24 months” to “12 months”

(continued) Cotellic (Cobimetinib) 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

Authorization/Notification Guidelines: Cotellic): Authorization will be issued/approved for 12 months for patients less

than 19 years of age Initial authorization for the treatment of melanoma will be

issued/approved for 12 months based on all of the following criteria:

- Diagnosis of melanoma; and

- Disease is one of the following:

Unresectable Metastatic

and

- Disease is positive for one of the following mutations:

BRAF V600E BRAF V600K

Reauthorization for the treatment of Melanoma will be issued/approved for 12 months if patient does not show evidence of progressive disease while on Cotellic therapy

Dyanavel XR (Amphetamine)

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 two of the following (see Therapeutic Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic Equivalent Medications):

Brand or generic Adderall XR, Concerta, Metadate CD or Vyvanse

Entresto (Valsartan – Sacubitril)

Revised

Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Entestro (Valsartan-Sacubitril): o Revised initial authorization criteria to indicate authorization will be

issued/approved for 12 months based on one of the following criteria:

As continuation of therapy initiated during an inpatient stay; or All of the following:

- Diagnosis of heart failure (with or without hypertension); and

- Ejection fraction is less than or equal to 35 percent; and



REVISED



Apr. 1, 2016

Entresto (Valsartan – Sacubitril) (continued)

Revised

- Heart failure is classified as one of the following:

New York Heart Association Class II New York Heart Association Class III New York Heart Association Class IV and

- One of the following:

Patient is on a stabilized dose and receiving concomitant therapy with one of the following beta-blockers:

o bisoprolol o carvedilol o metoprolol succinate or

Patient has a contraindication or intolerance to beta-blocker therapy

and

- Most recent (while on therapeutic, or maximally tolerated, doses of evidence-based recommended medications for heart failure) B-

type natriuretic peptide level (BNP) is one of the following: ≥150 pg/mL (or NT-proBNP ≥600 pg/mL); or A BNP ≥100 pg/mL (or NT-proBNP ≥400 pg/mL) if the patient

had been hospitalized for heart failure in the past 12 months and

- Patient does not have a history of angioedema associated with

use of the following: Angiotensin converting enzyme (ACE) Inhibitor therapy

Angiotensin receptor blocker (ARB) therapy and

- Patient will discontinue any use of concomitant ACE Inhibitor or

ARB before initiating treatment with Entresto; ACE inhibitors must

be discontinued at least 36 hours prior to initiation of Entresto; and

- Patient is not concomitantly on aliskiren therapy; and

- Entresto is prescribed by, or in consultation with, a cardiologist

o Revised reauthorization criteria; added criterion requiring: The Entresto dose has been titrated to a dose of 97 mg/103 mg

twice daily, or to a maximally tolerated dose as tolerated by the

patient



REVISED



Apr. 1, 2016 Epaned (Enalapril) Revised Revised prior authorization/medical necessity guidelines (see Prior Authorization/ Medical Necessity Guidelines: Non-Solid Oral Dosage Forms): o Revised initial authorization criteria to indicate authorization will be


Patient is unable to ingest a solid dosage form (e.g., an oral tablet or

capsule) due to one of the following:

- age

- oral/-motor difficulties

- dysphagia

or Patient utilizes a feeding tube for medication administration

o Removed reauthorization criteria

Finacea 15% Foam (Azelaic Acid)

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 therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with Finacea Gel 15% and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Genvoya

Revised Revised step therapy guidelines (see Step Therapy Guidelines: Genvoya); added new/additional criterion (option) requiring patient has a creatinine clearance that falls within the range of 30 to 50 mL per minute

Histex-AC Syrup (Codeine/Phenylephrine/Triprolidine)

Removed Removed coverage guidelines/drug listing

Imatinib (Generic Gleevec)

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 based on one of the following

criteria (see Prior Authorization/Notification Guidelines: Oral Oncology): Patient is under the age of 19 years; or Patient has a diagnosis that is listed in the NCCN Drugs and Biologics

Compendium with Categories of Evidence and Consensus of 1, 2A, or 2B for that specific oncology agent; or

Patient is receiving treatment for a non-oncology indication that is



REVISED



Apr. 1, 2016 Imatinib (Generic Gleevec) (continued)

New

recognized in the product labeling, a published compendium (i.e., Micromedex, Clinical Pharmacology), or is demonstrated as proven in the peer reviewed medical literature.

o Added therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with Gleevec (see Therapeutic

Equivalent Guidelines: Drug Coverage Criteria - New and Therapeutic

Equivalent Medications)

Keveyis (Dichlorphenamide)

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 therapeutic equivalent guidelines requiring history of intolerance or therapeutic failure to treatment with acetazolamide (generic Diamox) and corresponding reference link to policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Nexium Suspension (Esomeprazole)

Revised

Revised prior authorization/medical necessity guidelines (see Prior Authorization/ Medical Necessity Guidelines: Non-Solid Oral Dosage Forms): o Revised initial authorization criteria to indicate authorization will be

issued/approved for 12 months based on one of the following criteria: Patient is unable to ingest a solid dosage form (e.g., an oral tablet or


- age


- dysphagia or

Patient utilizes a feeding tube for medication administration


Ninlaro (Ixazomib)

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: Ninlaro): Authorization will be issued/approved for 12 months for patients less



REVISED



Apr. 1, 2016 Ninlaro (Ixazomib) (continued)

New

than 19 years of age Initial authorization for the treatment of multiple myeloma will be

issued/approved for 12 months based on all of the following criteria:

- Diagnosis of multiple myeloma; and

- Patient has received at least one prior therapy for multiple

myeloma [e.g., Velcade (bortezomib)]; and

- Used in combination with Revlimid (lenalidomide); and

- Used in combination with dexamethasone

Reauthorization for the treatment of multiple myeloma will be issued/approved for 12 months based on the following criterion:

- Patient does not show evidence of progressive disease while on

Ninlaro therapy

Orenitram (Treprostinil)

Revised

Revised prior authorization/medical necessity guidelines (see Prior Authorization/ Medical Necessity Guidelines: Orenitram): o Revised initial authorization criteria for the treatment of pulmonary

arterial hypertension to indicate authorization will be issued/approved for 12 months based on one of the following criteria:

All of the following:

- As continuation of therapy; and

- 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 Orenitram

or Uptravi; and

- Patient is not taking Orenitram or Uptravi in combination with a

prostanoid/prostacyclin analogue (e.g., epoprostenol, iloprost, treprostinil)

or All of the following:


All of the following: o Pulmonary arterial hypertension is symptomatic o Submission of medical records documenting diagnosis of

pulmonary arterial hypertension that is confirmed by right heart catheterization

or Patient is currently on any therapy for the diagnosis of

pulmonary arterial hypertension and



REVISED



Apr. 1, 2016 Orenitram (Treprostinil) (continued)

Revised - History of failure, contraindication or intolerance to both of the

following One of the following

o A PDE-5 inhibitor [e.g., sildenafil citrate (generic Revatio), Adcirca or Revatio*] (*Note: Revatio brand tablets are typically excluded from coverage; tried/failed criteria may

be in place); or

o Adempas and

An ERA (e.g., Letairis, Opsumit or Tracleer) and



o Revised reauthorization criteria for the treatment of pulmonary arterial

hypertension to indicate authorization will be issued/approved for 12 months based on both of the following criteria:

Documentation the patient is receiving clinical benefit to Orenitram therapy; and

Patient is not taking Orenitram or Uptravi in combination with a prostanoid/prostacyclin analogue (e.g., epoprostenol, iloprost, treprostinil)

Prevacid (Lansoprazole) Solutab Lansoprazole Generic

Revised

Revised prior authorization/medical necessity guidelines (see Prior Authorization/ Medical Necessity Guidelines: Non-Solid Oral Dosage Forms): o Revised initial authorization criteria to indicate authorization will be


Patient is unable to ingest a solid dosage form (e.g., an oral tablet or capsule) due to one of the following:

- age - oral/-motor difficulties - dysphagia



Purixan 20mg/ml (Mercaptopurine)

Revised Revised prior authorization/medical necessity guidelines (see Prior Authorization/ Medical Necessity Guidelines: Non-Solid Oral Dosage Forms): o Revised initial authorization criteria to indicate authorization will be



REVISED



Apr. 1, 2016 Purixan 20mg/ml (Mercaptopurine) (continued)

Revised issued/approved for 12 months based on one of the following criteria: Patient is unable to ingest a solid dosage form (e.g., an oral tablet or


- age


- dysphagia



Repatha (Evolocumab)

Revised

Revised prior authorization/medical necessity guidelines (see Prior Authorization/ Medical Necessity Guidelines: Repatha): o Revised initial authorization criteria for the treatment of primary

hyperlipidemia: Removed/replaced 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:

o 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 o Both of the following:

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

Patient has a history of failure or intolerance to Praluent

therapy Added criterion requiring one of the following as documented by

prescription claims history or medical record:

- History of failure after 12 consecutive weeks of Praluent; or

- History of intolerance to Praluent therapy



REVISED



Apr. 1, 2016 Sotylize (Sotalol Hydrochloride)

Revised Revised prior authorization/medical necessity guidelines (see Prior Authorization/Medical Necessity Guidelines: Non-Solid Oral Dosage Forms): o Revised initial authorization criteria to indicate authorization will be



- age


- dysphagia or

Patient utilizes a feeding tube for medication administration o Removed reauthorization criteria

Stribild® (Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir

Disoproxil Fumarate)

Revised Revised step therapy guidelines (see Step Therapy Guidelines: Stribild); added new/additional criterion (option) requiring patient has a hepatitis B coinfection

Tagrisso (Osimertinib)

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 Authorization/Notification Guidelines: Tagrisso):

Authorization will be issued/approved for 12 months for patients less than 19 years of age

Initial authorization for the treatment of non-small cell lung cancer (NSCLC) will be issued/approved for 12 months based on all of the following criteria:

- Diagnosis of metastatic non-small cell lung cancer (NSCLC); and

- Disease is epidermal growth factor receptor (EGFR) T790M

mutation-positive; and

- History of failure, contraindication, or intolerance to prior EGFR

tyrosine kinase inhibitor (TKI) therapy [e.g., Tarceva (erlotinib), Gilotrif (afatinib)]

Reauthorization for the treatment of non-small cell lung cancer (NSCLC) will be issued/approved for 12 months based on the following criterion:

- Patient does not show evidence of progressive disease while on

Tagrisso therapy



REVISED



Apr. 1, 2016

Uptravi (Selexipag)

Revised

Added prior authorization/medical necessity guidelines to indicate (see Prior Authorization/Medical Necessity Guidelines: Uptravi): o Initial authorization for the treatment of pulmonary arterial

hypertension will be issued/approved for 12 months based on one of the following criteria:


- As continuation of therapy; and

- 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 Orenitram or Uptravi; and



or All of the following:



o Pulmonary arterial hypertension is symptomatic o Submission of medical records documenting diagnosis of

pulmonary arterial hypertension that is confirmed by right heart catheterization

or Patient is currently on any therapy for the diagnosis of

pulmonary arterial hypertension

and

- History of failure, contraindication or intolerance to both of the

following One of the following

o A PDE-5 inhibitor [e.g., sildenafil citrate (generic Revatio), Adcirca or Revatio*] (*Note: Revatio brand tablets are typically excluded from coverage; tried/failed criteria may be in place); or

o Adempas and

An ERA (e.g., Letairis, Opsumit or Tracleer) and


prostanoid/prostacyclin analogue (e.g., epoprostenol, iloprost,



REVISED



Apr. 1, 2016 Uptravi (Selexipag) (continued)

Revised treprostinil) o Reauthorization for the treatment of pulmonary arterial hypertension

will be issued/approved for 12 months based on both of the following criteria: Documentation the patient is receiving clinical benefit to Orenitram

therapy; and

Patient is not taking Orenitram or Uptravi in combination with a prostanoid/prostacyclin analogue (e.g., epoprostenol, iloprost, treprostinil)

Zegerid Suspension (Omeprazole/Sodium

Bicarbonate)

Revised Revised prior authorization/medical necessity guidelines (see Prior Authorization/ Medical Necessity Guidelines: Non-Solid Oral Dosage

Forms): o Revised initial authorization criteria to indicate authorization will be



- age


- dysphagia



REVISED


Elbow Replacement Surgery (Arthroplasty)

Apr. 1, 2016

Revised coverage rationale; replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th

edition, 2016” (effective Apr. 1,

2016)

For information regarding medical necessity review, see MCG™ Care Guidelines, 20th edition, 2016, Elbow Arthroplasty, S-420 (ISC).

Electrical and Ultrasound Bone Growth Stimulators

Apr. 1, 2016

Revised coverage rationale: o Replaced references to “MCG™

Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016”

(effective Apr. 1, 2016); refer to 20th edition for complete

Two MCG™ Care Guidelines 20th edition, 2016 are identified, one for electrical and electromagnetic bone growth stimulators, and one for ultrasonic bone growth stimulators. For information regarding medical necessity review of electrical and

electromagnetic bone growth stimulators, see MCG™ Care Guidelines, 20th edition, 2016, Bone Growth Stimulators, Electrical and



REVISED


Electrical and Ultrasound Bone Growth Stimulators (continued)

Apr. 1, 2016 details on applicable updates to the MCG™ Care Guidelines

Electromagnetic ACG: A-0565 (AC). For information regarding medical necessity review of ultrasonic bone growth stimulators, see MCG™ Care Guidelines, 20th edition, 2016, Bone Growth Stimulators, Ultrasonic ACG: A-0414 (AC).

Entyvio™

(Vedolizumab)

Apr. 1, 2016

Revised conditions of coverage to

indicate precertification with medical director review is required

Updated supporting information to reflect the most current background and FDA information

1. Entyvio is proven and medically necessary for the treatment of

Crohn's disease (CD) when all of the following criteria are met:1 A. Diagnosis of moderately to severely active Crohn’s disease; and B. One of the following:

1) History of failure, contraindication, or intolerance to at least one of the following conventional therapies: i. Tumor necrosis factor (TNF) blocker [e.g., Humira

(adalimumab), Cimzia (certolizumab)] ii. Immunomodulator (e.g., azathioprine, 6-mercaptopurine) iii. Corticosteroid

2) Corticosteroid dependent (e.g., unable to successfully taper corticosteroids without a return of the symptoms of UC)

and C. Entyvio is initiated and titrated according to US Food and Drug

Administration labeled dosing for Crohn’s disease up to a maximum of 300mg every 8 weeks (or equivalent dose and interval schedule); and

D. Patient is not receiving Entyvio in combination with either of the following: 1) Tumor necrosis factor (TNF) blocker [e.g., Humira

(adalimumab), Cimzia (certolizumab)]

2) Tysabri (natalizumab) 2. Entyvio (vedolizumab) is proven and medically necessary for the

treatment of ulcerative colitis (UC) when all of the following criteria are met: A. Diagnosis of moderately to severely active ulcerative colitis; and

B. One of the following: 1) History of failure, contraindication, or intolerance to at least one

of the following conventional therapies: i. Tumor necrosis factor (TNF) blocker [e.g., Humira

(adalimumab), Simponi (golimumab)] ii. Immunomodulator (e.g., azathioprine, 6-mercaptopurine)



REVISED


Entyvio™ (Vedolizumab) (continued)

Apr. 1, 2016 iii. Corticosteroid 2) Corticosteroid dependent (e.g., unable to successfully taper

corticosteroids without a return of the symptoms of UC); and C. Entyvio is initiated and titrated according to US Food and Drug

Administration labeled dosing for ulcerative colitis up to a maximum

of 300mg every 8 weeks (or equivalent dose and interval schedule); and

D. Patient is not receiving Entyvio in combination with either of the following: 1) Tumor necrosis factor (TNF) blocker [e.g., Humira

(adalimumab), Simponi (golimumab)]

2) Tysabri (natalizumab)

Genetic Testing

Apr. 1, 2016

Added reference link to policy titled Molecular Profiling to Guide Cancer Treatment

Revised coverage rationale;

modified list of applicable MCG™ Care Guidelines (effective Apr. 1,

2016): o Added new/additional

references to applicable MCG™ Care Guidelines, 20th edition, 2016

o Replaced existing references to “MCG™ Care Guidelines, 19th

edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016”; refer to 20th edition for

complete details on applicable updates to the MCG™ Care Guidelines

The following genetic tests are medically necessary when criteria are met: Arrhythmogenic right ventricular cardiomyopathy (ARVC genes).

For information regarding medical necessity review, see MCG™ Care

Guidelines, 20th edition, 2016, Arrhythmogenic Right Ventricular Cardiomyopathy - ARVC Genes ACG: A-0627 (AC).

Ashkenazi Jewish genetic panel. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Ashkenazi Jewish Genetic Panel ACG: A-0592 (AC)

Catecholaminergic polymorphic ventricular tachycardia (RYR2 and CASQ2 Genes). For information regarding medical necessity review, see MCG™ Care Guidelines, 20th edition, 2016, Catecholaminergic Polymorphic Ventricular Tachycardia - RYR2 and

CASQ2 Genes ACG: A-0636 (AC) Dilated cardiomyopathy (ANKRD1, DMD, GATAD1, LDB3, LMNA,

MYBPC3, MYH7, RBM20, SCN5A, TNNI3, TNNT2, and TTN Genes).

For information regarding medical necessity review, see MCG™ Care Guidelines, 20th edition, 2016, Dilated Cardiomyopathy - ANKRD1, DMD, GATAD1, LDB3, LMNA, MYBPC3, MYH7, RBM20, SCN5A, TNNI3, TNNT2,

and TTN Genes ACG: A-0648 (AC) Hypertrophic cardiomyopathy (Sarcomere Genes). For information

regarding medical necessity review, see MCG™ Care Guidelines, 20th edition, 2016, Hypertrophic Cardiomyopathy - Sarcomere Genes ACG: A-0633 (AC)

Long QT Syndrome (Jervell and Lange-Nielsen Syndrome, Type 1



REVISED


Genetic Testing (continued)

Apr. 1, 2016

and Type 2) - KCNE1 and KCNQ1 Genes. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Long QT Syndrome (Jervell and Lange-Nielsen Syndrome, Type 1 and Type 2) - KCNE1 and KCNQ1 Genes ACG: A-0607 (AC)

Long QT Syndrome, Type 1 (Romano-Ward Syndrome) - KCNE1,

KCNE2, KCNH2, KCNQ1, and SCN5A Genes. For information regarding

medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Long QT Syndrome, Type 1 (Romano-Ward Syndrome) - KCNE1, KCNE2, KCNH2, KCNQ1, and SCN5A Genes ACG: A-0831 (AC)

Long QT Syndrome, Type 7 (Andersen-Tawil Syndrome) - KCNJ2 Gene. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Long QT Syndrome, Type 7

(Andersen-Tawil Syndrome) - KCNJ2 Gene ACG: A-0833 (AC) Long QT Syndrome, Type 8 (Timothy Syndrome) - CACNA1C Gene.

For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Long QT Syndrome, Type 8 (Timothy Syndrome) - CACNA1C Gene ACG: A-0834 (AC)

Lynch Syndrome (EPCAM, MLH1, MSH2, MSH6, and PMS2 Genes).

For information regarding medical necessity review, see MCG™ Care

Guidelines, 20th edition, 2016, Lynch Syndrome - EPCAM, MLH1, MSH2, MSH6, and PMS2 Genes ACG: A-0533 (AC)

The clinical utility of the following genetic tests have not been established and therefore these tests are not medically necessary: 5-Fluorouracil pharmacogenetics (DPYD, MTHFR, and TYMS

Genes). See MCG™ Care Guidelines, 20th edition, 2016, 5-Fluorouracil Pharmacogenetics - DPYD, MTHFR, and TYMS Genes ACG: A-0665 (AC)

Amyotrophic Lateral Sclerosis (C9ORF72 and SOD1 Genes).See MCG™ Care Guidelines, 20th edition, 2016, Amyotrophic Lateral Sclerosis

(ALS) - C9ORF72 and SOD1 Genes ACG: A-0591 (AC) Clopidogrel pharmacogenetics (CYP2C19 Gene). See MCG™ Care

Guidelines, 20th edition, 2016, Clopidogrel Pharmacogenetics - CYP2C19

Gene ACG: A-0631 (AC) Coronary artery disease (9p21 Allele). See MCG™ Care Guidelines,

20th edition, 2016,Coronary Artery Disease - 9p21 Allele ACG: A-0657 (AC)

Coronary artery disease (KIF6 Gene). See MCG™ Care Guidelines, 20th edition, 2016, Coronary Artery Disease - KIF6 Gene ACG: A-0656 (AC)



REVISED



Apr. 1, 2016

Coronary artery disease genetic panel. See MCG™ Care Guidelines, 20th edition, 2016, Coronary Artery Disease Genetic Panel ACG: A-0658 (AC)

Genome-wide association studies. See MCG™ Care Guidelines, 20th edition, 2016, Genome-Wide Association Studies ACG: A-0531 (AC)

Hyperhomocysteinemia (MTHFR Gene). See MCG™ Care Guidelines,

20th edition, 2016, Hyperhomocysteinemia - MTHFR Gene ACG: A-0629 (AC)

Azathioprine and 6-Mercaptopurine pharmacogenetics - TPMT Gene. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Azathioprine and 6-Mercaptopurine Pharmacogenetics - TPMT Gene ACG: A-0628 (AC)

Irinotecan pharmacogenetics (UGT1A1 Gene). See MCG™ Care Guidelines, 20th edition, 2016, Irinotecan Pharmacogenetics - UGT1A1 Gene ACG: A-0624 (AC)

Malignant melanoma (cutaneous) - BAP1, CDK4, and CDKN2A Genes. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Malignant Melanoma (Cutaneous) -

BAP1, CDK4, and CDKN2A Genes ACG: A-0601 (AC)

Malignant melanoma (uveal) - BAP1, CDK4, and CDKN2A Genes. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Malignant Melanoma (Uveal) - BAP1, CDK4, and CDKN2A Genes ACG: A-0836 (AC)

MicroRNA detection – cancer. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016,

MicroRNA Detection – Cancer ACG: A-0705 (AC) MicroRNA detection - heart failure. For information regarding medical

necessity review see MCG™ Care Guidelines, 20th edition, 2016, MicroRNA Detection - Heart Failure ACG: A-0838 (AC)

MicroRNA detection - inflammatory bowel disease. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, MicroRNA Detection - Inflammatory Bowel Disease ACG:

A-0839 (AC) MicroRNA detection - ischemic heart disease. For information

regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, MicroRNA Detection - Ischemic Heart Disease ACG: A-0840 (AC)

MicroRNA detection - kidney disease. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016,



REVISED



Apr. 1, 2016

MicroRNA Detection - Kidney Disease ACG: A-0841 (AC) Parkinson disease (ATP13A2, GBA, LRRK2, MAPT, PARK2, PARK7,

PINK1, and SNCA Genes). See MCG™ Care Guidelines, 20th edition, 2016, Parkinson Disease - ATP13A2, GBA, LRRK2, MAPT, PARK2, PARK7, PINK1, and SNCA Genes ACG: A-0671 (AC)

Prostate cancer - BRCA1 and BRCA2 Genes. For information

regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Prostate Cancer - BRCA1 and BRCA2 Genes ACG: A-0612 (AC)

Prostate cancer - PCA3 Gene. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Prostate Cancer - PCA3 Gene ACG: A-0855 (AC)

Proteomics - ovarian cancer biomarker panel (OVA1). For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Proteomics - Ovarian Cancer Biomarker Panel (OVA1) ACG: A-0709 (AC)

Proteomics - ovarian cancer biomarker panel (ROMA). For information regarding medical necessity review see MCG™ Care

Guidelines, 20th edition, 2016, Proteomics - Ovarian Cancer Biomarker

Panel (ROMA) ACG: A-0858 (AC) Psychotropic medication pharmacogenetics - BDNF, COMT, DRD,

HTR, SLC6A4, and TPH1 Genes. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Psychotropic Medication Pharmacogenetics - BDNF, COMT, DRD, HTR, SLC6A4, and TPH1 Genes ACG: A-0859 (AC)

Psychotropic medication pharmacogenetics - CYP450 Polymorphisms and AmpliChip Panel. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Psychotropic Medication Pharmacogenetics - CYP450 Polymorphisms and

AmpliChip Panel ACG: A-0692 (AC) Psychotropic medication pharmacogenetics - Gene Panels. For

information regarding medical necessity review see MCG™ Care

Guidelines, 20th edition, 2016, Psychotropic Medication Pharmacogenetics - Gene Panels ACG: A-0861 (AC)

Psychotropic medication pharmacogenetics - HLA Typing. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Psychotropic Medication Pharmacogenetics - HLA Typing ACG: A-0862 (AC)

Septin 9 (SEPT9) DNA methylation testing. See MCG™ Care



REVISED



Apr. 1, 2016

Guidelines, 20th edition, 2016, Septin 9 (SEPT9) DNA Methylation Testing ACG: A-0706 (AC)

Tamoxifen pharmacogenetics (CYP2D6 Gene). See MCG™ Care Guidelines, 20th edition, 2016,Tamoxifen Pharmacogenetics - CYP2D6 Gene ACG: A-0647 (AC)

Telomere analysis. See MCG™ Care Guidelines, 20th edition, 2016,

Telomere Analysis ACG: A-0672 (AC) Topographic genotyping (PathFinderTG). See MCG™ Care

Guidelines, 20th edition, 2016, Topographic Genotyping – PathFinderTG ACG: A-0632 (AC)

Warfarin pharmacogenetics (CYP2C9, CYP4F2 and VKORC1Genes). See MCG™ Care Guidelines, 20th edition, 2016,

Warfarin Pharmacogenetics - CYP2C9, CYP4F2, and VKORC1 Genes ACG: A-0587 (AC)

Whole gnome/exome sequencing – cancer. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing – Cancer ACG: A-0710 (AC)

Whole gnome/exome sequencing - cardiovascular disorders. For

information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing - Cardiovascular Disorders ACG: A-0865 (AC)

Whole gnome/exome sequencing - immunodeficiency disorders. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing -

Immunodeficiency Disorders ACG: A-0866 (AC) Whole gnome/exome sequencing - intellectual disability. For

information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing -

Intellectual Disability ACG: A-0867 (AC) Whole gnome/exome sequencing - metabolic disorders. For

information regarding medical necessity review see MCG™ Care

Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing - Metabolic Disorders ACG: A-0868 (AC)

Whole gnome/exome sequencing - mitochondrial DNA disorders. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing - Mitochondrial DNA Disorders ACG: A-0869 (AC)

Whole gnome/exome sequencing - neurodevelopmental



REVISED



Apr. 1, 2016 disorders. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing - Neurodevelopmental Disorders ACG: A-0870 (AC)

Whole gnome/exome sequencing - neurologic disorders. For information regarding medical necessity review see MCG™ Care

Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing -

Neurologic Disorders ACG: A-0871 (AC) Whole gnome/exome sequencing - undiagnosed genetic

disorders. For information regarding medical necessity review see MCG™ Care Guidelines, 20th edition, 2016, Whole Genome/Exome Sequencing - Undiagnosed Genetic Disorders ACG: A-0872 (AC)

Hip Replacement

Surgery (Arthroplasty)

Apr. 1, 2016 Revised coverage rationale;

replaced references to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016” (effective Apr. 1, 2016)

Updated list of applicable CPT codes; removed coding

clarification language Updated supporting information to

reflect the most current FDA information and references

For information regarding medical necessity review, see:

MCG™ Care Guidelines, 20th edition, 2016, Hip Arthroplasty, S-560 (ISC).

MCG™ Care Guidelines, 20th edition, 2016, Hip: Displaced Fracture of Femoral Neck, Hemiarthroplasty, S-600 (ISC).

Hysterectomy for Benign Conditions

Apr. 1, 2016

Revised coverage rationale: o Replaced reference to “MCG™


(effective Apr. 1, 2016); refer to 20th edition for complete details on applicable updates to

the MCG™ Care Guidelines Updated supporting information to

reflect the most current FDA information and references

For information regarding medical necessity review, when applicable, see the following MCG™ Care Guidelines, 20th edition, 2016:

Hysterectomy, Abdominal, ORG: S-650 (ISC) Hysterectomy, Vaginal, ORG: S-660 (ISC) Hysterectomy, Laparoscopic, ORG: S-665 (ISC)



REVISED


Implanted Electrical Stimulator for Spinal Cord

Apr. 1, 2016 Revised coverage rationale: o Replaced reference to “MCG™


(effective Apr. 1, 2016); refer

to 20th edition for complete details on applicable updates to the MCG™ Care Guidelines

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Implanted Electrical Stimulator, Spinal Cord. ACG: A-0243 (AC).

Manipulative Therapy

Apr. 1, 2016

Revised conditions of coverage/special considerations:

o Added reference link to https://www.myoptumhealthphysicalhealth.com/CPwelcome.html for additional information regarding the clinical support and utilization management

services provided by OptumHealth Care Solutions, including clinical review criteria

o Added language to indicate: Precertification is required

for services covered under the member's general


For commercial plans, precertification is not

required, but is encouraged for out-of-network services

performed in the office that are covered under the member's general benefits package

If precertification is not obtained, Oxford may

review for medical necessity

Manipulative therapy is proven and medically necessary when used in the treatment of musculoskeletal disorders except as noted

below. Manipulative therapy is unproven and not medically necessary for treatment of: Non-musculoskeletal disorders (e.g., asthma, otitis media, infantile colic,

etc)

Prevention/maintenance/custodial care Internal organ disorders (e.g., gallbladder, spleen, intestinal, kidney, or

lung disorders) Temporomandibular joint (TMJ) disorder Scoliosis correction Craniosacral therapy (cranial manipulation/upledger technique) Manipulative services that utilize nonstandard techniques such as applied

kinesiology technique, NUCCA, network and neural organizational technique

The role of manipulation for the above has not been established in scientific literature. A beneficial impact on health outcomes, e.g., improved physical

function, durable pain relief, has not been established.

Manipulative therapy is unproven and not medically necessary when any of the following apply: 1. The patient's condition has returned to the pre-symptom state. 2. Little or no improvement is demonstrated within 30 days of the initial

visit despite modification of the treatment plan. 3. Concurrent manipulative therapy, for the same or similar condition,

provided by another health professional whether or not the healthcare



REVISED


Manipulative Therapy (continued)

Apr. 1, 2016 after the service is rendered Revised coverage rationale;

removed content/language pertaining to administration of benefits for chiropractic services

and osteopathic manipulative

treatment Removed lists of applicable CPT

and HCPCS codes for Chiropractic Services

Updated list of applicable CPT codes for Osteopathic

Manipulative Treatment; added 98940, 98941, 98942 and 98943

Updated supporting information to reflect the most current clinical evidence, FDA information and references

professional is in the same professional discipline.

This policy does not address manipulation under anesthesia; refer to the policy titled Manipulation Under Anesthesia.

Observation Care

Apr. 1, 2016

Revised procedures and responsibilities: o Replaced reference to “MCG™


(effective Apr. 1, 2016); refer to 20th edition for complete details on applicable updates to the MCG™ Care Guidelines

o Updated notation:

Added language to indicate observation time ends when

all services related to observation care are completed (i.e., before discharge when the need for observation has ended but other services not meeting

the definition of observation

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, General Criteria: Observation Care (OCG): OC-022 (ISC)

Note: Observation time begins at the clock time, documented in the patient's record, which coincides with the time the patient is placed in a

bed for the purpose of initiating observation care in accordance with the physician's order. Observation time ends when all services related to observation care are completed (i.e.; before discharge when the need for observation has ended, but other services not meeting the definition of observation care are provided, the patient is actually discharged from

the hospital, or admitted as an inpatient).

Observation Care Review Process: Upon identification of a need for clinical review, Oxford will contact the facility via written request for medical records to be provided within 28 calendar days. Upon receipt of medical records, or in the absence of such following 28

calendar days from Oxford's initial request, the claim will be clinically



REVISED


Observation Care (continued)

Apr. 1, 2016 care are provided or the patient is actually discharged from the hospital, or admitted as an inpatient)

Removed language

indicating the medical record must include documentation that the physician explicitly assessed patient risk to determine that the patient would

benefit from observation care

Updated supporting information; replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines,

20th edition, 2016” (effective Apr.

1, 2016)

reviewed by Oxford. The reviewer will consider all available information, including but not limited to notations documented in any authorization, claim history, and medical records (if provided). A determination will then be made as to the necessity for observation care.

Obstructive Sleep Apnea Treatment

Apr. 1, 2016


Care Guidelines, 19th edition, 2015” with “MCG™ Care

Guidelines, 20th edition, 2016” (effective Apr. 1, 2016); refer to 20th edition for complete details on applicable updates to the MCG™ Care Guidelines

Nonsurgical Treatment Removable oral appliances are proven and medically necessary for treating obstructive sleep apnea (OSA) as documented by polysomnography. Refer to policy titled Attended Polysomnography for

Evaluation of Sleep Disorders for further information. For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Oral Appliances (Mandibular Advancement Devices), A-0341 (ACG).

Removable oral appliances are unproven and not medically necessary for treating central sleep apnea.

This type of sleep apnea is caused by impaired neurological function, and these devices are designed to manage physical obstructions. Nasal dilator devices are unproven and not medically necessary for treating obstructive sleep apnea (OSA). There is insufficient clinical evidence supporting the safety and efficacy of

nasal dilators for treating OSA. Results from available studies indicate that



REVISED


Obstructive Sleep Apnea Treatment (continued)

Apr. 1, 2016

therapeutic response is variable among the participants. Further research from larger, well-designed studies is needed to evaluate the effectiveness of the device compared with established treatments for OSA, to determine its long-term effectiveness and to determine which patients would benefit from this therapy.

Surgical Treatment The following surgical procedures are proven and medically necessary for treating obstructive sleep apnea as documented by polysomnography. Refer to policy titled Attended Polysomnography for Evaluation of Sleep Disorders for further information. Also see the Definitions section of the policy for information on the definitions and

severity of OSA. Uvulopalatopharyngoplasty (UPPP)

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Uvulopalatopharyngoplasty (UPPP), A-0248 (ACG).

Maxillomandibular advancement surgery (MMA)

For information regarding medical necessity review, when applicable, see

MCG™ Care Guidelines, 20th edition, 2016, Maxillomandibular Osteotomy and Advancement, A-0248 (ACG).

Multilevel procedures whether done in a single surgery or phased multiple surgeries. There are a variety of procedure combinations, including mandibular osteotomy and genioglossal advancement with hyoid myotomy (GAHM).

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Mandibular Osteotomy, A-0247 (ACG).

Radiofrequency ablation of the soft palate and/or tongue base is proven and medically necessary for treating mild to moderate obstructive sleep apnea as documented by polysomnography. Refer

to policy Attended Polysomnography for Evaluation of Sleep Disorders for further information. In addition to the criteria listed above, radiofrequency ablation of the soft palate and/or tongue base is medically necessary for patients who fail to improve with or cannot tolerate an adequate trial of continuous positive airway pressure (CPAP) or another device, including bi-level positive airway pressure (BiPAP), auto-titrating positive airway pressure (APAP) and/or oral appliances.



REVISED



Apr. 1, 2016

The following surgical procedures are unproven and not medically necessary for treating obstructive sleep apnea: Laser-assisted uvulopalatoplasty (LAUP) Palatal implants Lingual suspension - also referred to as tongue stabilization, tongue

stitch or tongue fixation

Transoral robotic surgery (TORS) Implantable hypoglossal nerve stimulation

There is insufficient evidence to conclude that laser-assisted uvulopalatoplasty (LAUP) results in improved apnea-hypopnea index (AHI) or secondary outcomes. Some studies saw a worsening of symptoms as

well as increased complications. Results of studies provide preliminary but inconsistent evidence that palatal implants benefit patients with mild to moderate OSA. However, the magnitude of the benefits has been small; the largest randomized controlled trial (RCT) found that average OSA worsened in spite of treatment; and the

available studies involved ≤ 1 year of patient monitoring after treatment.

Additional studies are needed to determine the role of palatal implants in the management of OSA. There is insufficient evidence to support the safety, efficacy and long-term outcomes of lingual suspension in the treatment of OSA. The published peer-reviewed medical literature includes a few small, uncontrolled studies

with short-term follow-up. Large, controlled studies, with long-term follow-up, comparing lingual suspension to established procedures are necessary. There is insufficient evidence to support the safety, efficacy and long-term

outcomes of transoral robotic surgery (TORS) in the treatment of OSA. Large, controlled studies, with long-term follow-up, comparing TORS to established procedures are necessary.

There is insufficient evidence to support the safety, efficacy and long-term outcomes of hypoglossal nerve stimulation in the treatment of OSA. The optimal patient selection criteria for the use of hypoglossal nerve stimulation have not been defined. Randomized controlled trials or comparative effectiveness trials with long-term follow-up, comparing hypoglossal nerve stimulation to established procedures are necessary to evaluate the



REVISED



Apr. 1, 2016 effectiveness of this technology. Follow-up polysomnography should be performed following surgery to evaluate response to treatment (Kushida et al., 2006; Ferguson et al., 2006). Refer to policy Attended Polysomnography for Evaluation of Sleep

Disorders for further information.

Occipital Neuralgia and Headache Treatment

Apr. 1, 2016

Added conditions of coverage to indicate: o Precertification is required for

services covered under the member's general benefits package when performed in

the office of a participating provider

o For Commercial plans, precertification is not required, but is encouraged, for out-of-

network services performed in the office that are covered

under the member's general benefits package

o If precertification is not obtained, Oxford may review for medical necessity after the service is rendered

Injection of local anesthetics and/or steroids, used as occipital nerve blocks, is proven and medically necessary for the treatment of pain due to malignancy involving the head and neck.

Injection of local anesthetics and/or steroids, used as occipital nerve blocks, is unproven and not medically necessary for the diagnosis and treatment of occipital neuralgia or headaches including migraine and cervicogenic headaches. There is insufficient evidence that greater occipital nerve blocks can be used as a specific diagnostic test for occipital neuralgia or headaches. The efficacy

of local injection therapies for occipital neuralgia or cervicogenic headache

and other headaches has not been established in well-designed clinical trials.

Refer to policy Botulinum Toxin A and B for information regarding the use of botulinum toxin for treatment of headaches. Surgery, including but not limited to the following, is unproven and not medically necessary for the treatment of occipital neuralgia or cervicogenic headache. Occipital neurectomy

Partial posterior intradural C1-C3 rhizotomy Rhizotomy of C1-C3 spinal dorsal roots Surgical decompression of second cervical nerve root and ganglion Surgical decompression of the greater occipital nerve

The available evidence is insufficient to conclude that surgery is an effective

treatment for occipital neuralgia or cervicogenic headache. The long-term efficacy of surgical procedures for occipital neuralgia or cervicogenic headache has not been established in well-designed clinical trials. Occipital neurectomy or surgical nerve decompression is unproven and not medically necessary for the treatment of headaches. The available evidence is insufficient to conclude that occipital neurectomy



REVISED


Occipital Neuralgia and Headache Treatment (continued)

Apr. 1, 2016

or nerve decompression including decompression of the supraorbital, supratrochlear, zygomaticotemporal, or greater occipital nerves is an effective treatment for headaches. The long-term efficacy of these procedures for headaches has not been established in well-designed clinical trials.

Radiofrequency ablation (thermal or pulsed) or denervation is unproven and not medically necessary for the treatment of occipital neuralgia or headaches including migraine, cluster and cervicogenic headaches. The available evidence from published studies is not sufficient to conclude that radiofrequency ablation or denervation is an effective treatment for

occipital neuralgia or cervicogenic headache. Well-designed studies are needed to evaluate the potential advantages of radiofrequency ablation for these conditions and to identify which patients would benefit from this procedure. Neurostimulation or electrical stimulation is unproven and not

medically necessary for the treatment of occipital neuralgia or

headaches including migraine, cluster and cervicogenic headaches. The available studies were limited and had significant methodological flaws, making it difficult to draw conclusions regarding the efficacy of electrical stimulation for the treatment of cervicogenic headache or occipital neuralgia. There are no well-designed randomized controlled studies in the medical literature comparing neurostimulation to established treatment options or a

sham procedure. Studies on larger populations with longer follow-up are needed to establish the benefits of neurostimulation and electrical stimulation for treating these conditions.

Orthognathic (Jaw)

Surgery

Apr. 1, 2016

Revised coverage

rationale/indications for coverage: o Replaced language indicating

“oral surgery is standardly

excluded from coverage; the list (in the policy) represents the exceptions to the oral surgery exclusion” with “orthognathic (jaw) surgery is a standard exclusion from

Orthognathic (jaw) surgery is a standard exclusion from coverage in most

fully-insured plans. The following list represents the covered exceptions to the oral surgery exclusion. 1. The following are eligible for coverage as reconstructive and medically

necessary: a. Acute traumatic injury, and post-surgical sequela (please see post-

surgical sequela in Definitions section of the policy) b. Cancerous or non-cancerous tumors and cysts, cancer and post-

surgical sequela (please see cancer sequela and post-surgical sequela in Definitions section of the policy).



REVISED


Orthognathic (Jaw) Surgery (continued)

Apr. 1, 2016

coverage for most fully insured plans; the list (in the policy) represents the covered exceptions to the oral surgery exclusion”

o Reformatted and revised

coverage criteria for reconstructive/medically necessary surgery; modified list of applicable functional impairments: Removed/replaced

“obstructive sleep apnea” Added:

- Moderate to severe obstructive sleep apnea, as measured by polysomnography (AASM

Obstructive Sleep Apnea;

and Practice Parameters for the Surgical Modifications of the Upper Airway for Obstructive Sleep Apnea in Adults), defined as:

moderate for AHI or RDI ≥ 15 and ≤ 30

severe for AHI or RDI > 30/hr

and

- Oropharyngeal narrowing secondary to maxillomandibular deficiency is the primary

cause of moderate to severe obstructive sleep apnea [see MCG Care Guidelines, 20th edition,

2. The following are eligible for coverage when the criteria are met (see criteria section below): a. Obstructive sleep apneal (refer to the policy titled Obstructive Sleep

Apnea Treatment for additional information), b. Cleft lip/palate (for cleft lip/palate related jaw surgery),

c. Congenital anomalies that meet the criteria for reconstructive.

Depending on a patient-specific clinical review, examples might include: midface hypoplasia, Pierre Robin Syndrome, Hemifacial Microsomia, and Treacher Collins Syndrome.

All orthognathic (jaw) surgeries are subject to some level of review.

For the above covered exceptions that require review the following criteria should be applied.

Criteria: Orthognathic surgery is a reconstructive procedure and is considered to be medically necessary when both the skeletal

deformity AND the functional impairment criteria below are met:

1. The presence of any of the following facial skeletal deformities associated with masticatory malocclusion: a. Anteroposterior discrepancies

1) Maxillary/Mandibular incisor relationship: overjet of 5mm or more, or a 0 to a negative value (norm 2mm).

2) Maxillary/Mandibular anteroposterior molar relationship

discrepancy of 4mm or more (norm 0 to 1mm). 3) These values represent two or more standard deviation from

published norms. b. Vertical discrepancies

Presence of a vertical facial skeletal deformity which is two or more standard deviations from published norms for accepted skeletal landmarks.

1) Open Bite a) No vertical overlap of anterior teeth. b) Unilateral or bilateral posterior open bite greater than 2mm.

2) Deep overbite with impingement or irritation of buccal or lingual soft tissues of the opposing arch.

3) Supraeruption of a dentoalveolar segment due to lack of occlusion.



REVISED



Apr. 1, 2016

2016, Maxillomandibular Osteotomy and Advancement A-0248 (ACG)]

o Added medical necessity

guidelines for treatment of

obstructive sleep apnea to indicate: For medical necessity plans,

in addition to the criteria listed in the policy, also refer to the following:

- Maxillomandibular advancement surgery (MMA): For information

regarding medical necessity review,

when applicable, see

MCG™ Care Guidelines, 20th edition, 2016, Maxillomandibular Osteotomy and Advancement, A-0248

(ACG) - Multilevel procedures

whether done in a single surgery or phased

multiple surgeries: There are a variety of

procedure

combinations, including mandibular osteotomy and genioglossal advancement with hyoid myotomy (GAHM)

c. Transverse discrepancies 1) Presence of a transverse skeletal discrepancy which is two or

more standard deviations from published norms. 2) Total bilateral maxillary palatal cusp to mandibular fossa

discrepancy of 4mm or greater, or a unilateral discrepancy of

3mm or greater, given normal axial inclination of the posterior

teeth. d. Asymmetries

1) Anteroposterior, transverse or lateral asymmetries greater than 3mm with concomitant occlusal asymmetry.

2. In addition to meeting the skeletal deformity requirement above, the patient must also have one or more of the following functional

impairments: a. Masticatory (chewing) and swallowing dysfunction due to skeletal

malocclusion (e.g., inability to incise/and or chew solid foods, choking on incompletely masticated solid foods, damage to soft tissue during mastication, malnutrition).

b. Documentation of speech deficits to support existence of speech

impairment skeletal malocclusion.

c. Moderate to severe obstructive sleep apnea as measured by polysomnography (AASM Obstructive Sleep Apnea; and Practice Parameters for the Surgical Modifications of the Upper Airway for Obstructive Sleep Apnea in Adults), defined as: Moderate for AHI or RDI ≥ 15 and ≤ 30 Severe for AHI or RDI > 30/hr

AND oropharyngeal narrowing secondary to maxillomandibular deficiency is the primary cause of moderate to severe obstructive sleep apnea.(see MCG Care Guidelines, 20th edition, 2016,

Maxillomandibular Osteotomy and Advancement A-0248 (ACG))

For Obstructive sleep apnea: In addition to the criteria above, please also refer to the following: Maxillomandibular advancement surgery (MMA)

For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Maxillomandibular Osteotomy

and Advancement, A-0248 (ACG). Multilevel procedures whether done in a single surgery or phased

multiple surgeries.



REVISED



Apr. 1, 2016 For information regarding medical necessity review, when applicable, see MCG™ Care

Guidelines, 20th

edition, 2016, Mandibular Osteotomy, A-0247 (ACG)


description of services and references

There are a variety of procedure combinations, including mandibular osteotomy and genioglossal advancement with hyoid myotomy (GAHM). For information regarding medical necessity review, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Mandibular Osteotomy, A-0247 (ACG).

Oscillatory Positive Expiratory Pressure Devices

Apr. 1, 2016

Revised coverage rationale: o Replaced reference to “MCG™

Care Guidelines, 19th edition,

2015” with “MCG™ Care Guidelines, 20th edition, 2016” (effective Apr. 1, 2016); refer to 20th edition for complete details on applicable updates to the MCG™ Care Guidelines

For information regarding medical necessity review of oscillatory positive expiratory pressure devices, when applicable, see MCG™ Care Guidelines, 20th edition, 2016, Noninvasive Positive Pressure Ventilation (CPAP, BiPAP)

ACG: A-0431 (AC). For information regarding nasal dilators, refer to the policy titled Obstructive Sleep Apnea Treatment.

Oxford's Outpatient Imaging Self-Referral Policy

Apr. 1, 2016 Revised coverage rationale; updated list of reimbursable Primary Care Physicians: o Added Advanced Nurse

Practitioners (APRN) located in

Connecticut (CT)

Refer to the policy for complete details on Oxford's Outpatient Imaging Self-Referral Policy.

Panniculectomy and Body Contouring Procedures

Apr. 1, 2016

Revised coverage rationale; added language pertaining to coverage limitations and exclusions to indicate: o Some states require benefit

coverage for services that

Oxford Health Care considers cosmetic procedures, such as

Panniculectomy Panniculectomy is considered reconstructive and medically necessary when the following criteria are present: a. Panniculus must hang below symphysis pubis; and b. The panniculus is the primary cause of skin conditions when present,

such a cellulitis requiring systemic antibiotics or transdermal skin

ulcerations that require medical treatment. c. There is presence of a functional impairment due to the panniculus;



REVISED


Panniculectomy and Body Contouring Procedures (continued)

Apr. 1, 2016

repair of external congenital anomalies in the absence of a functional impairment; refer to the member specific benefit document

Cosmetic procedures are

excluded from coverage - Procedures that correct

an anatomical congenital anomaly without improving or restoring physiologic function are

considered cosmetic procedures

- The fact that a covered person may suffer psychological consequences or socially

avoidant behavior as a

result of an injury, sickness or congenital anomaly does not classify surgery (or other procedures done to relieve such

consequences or behavior) as a reconstructive procedure

Any procedure that does not

meet the reconstructive criteria in the indications for Coverage section of the

policy is excluded from coverage

Updated supporting information; replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016”

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 stated above in this document.

3. Performed post childbirth in order to return to pre pregnancy shape. 4. Performed for intertrigo, a superficial inflammatory response or any other

condition that does not meet the criteria above in this document.

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



REVISED


Panniculectomy and Body Contouring Procedures (continued)

Apr. 1, 2016 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. Coverage Limitations and Exclusions Some states require benefit coverage for services that Oxford Health Plans considers cosmetic procedures, such as repair of external congenital anomalies in the absence of a functional impairment. Please refer to

member specific benefit document.

1. Cosmetic Procedures are excluded from coverage. Procedures that correct an anatomical Congenital Anomaly without improving or restoring physiologic function are considered Cosmetic Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other procedures done to relieve

such consequences or behavior) as a reconstructive procedure. 2. Any procedure that does not meet the reconstructive criteria above in the

Indications for Coverage section

Pneumatic

Compression Devices

Apr. 1, 2016


o Replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care

Guidelines, 20th edition, 2016” (effective Apr. 1, 2016); refer to 20th edition for complete details on applicable updates to the MCG™ Care Guidelines

For information regarding medical necessity review of pneumatic

compression devices, see MCG™ Care Guidelines, 20th edition, 2016, Intermittent Pneumatic Compression with Extremity Pump ACG: ACG: A-0340 (AC).



REVISED


Preventive Care Services

Apr. 1, 2016

Revised list of applicable procedure and diagnosis codes:

Preventive Care Services

o Modified table headings; replaced column/content

descriptor titled “Claims Edit Criteria” with “Preventive

Benefit Instructions” o Revised service description for

Screening for Depression in Adults: Removed December 2009

USPSTF ‘B’ rating Added January 2016

USPSTF ‘B’ rating: - The USPSTF recommends

screening for depression

in the general adult population, including pregnant and postpartum women

- The USPSTF recommends screening should be implemented with adequate systems in place to ensure accurate diagnosis, effective

treatment, and appropriate follow-up

Expanded Women’s Preventive Health

o Modified table headings; replaced column/content descriptor titled “Claims Edit Criteria” with “Preventive Benefit Instructions”

o Revised coverage guidelines for Contraceptive Methods

Refer to the policy for complete details on the coverage guidelines for Preventive Care Services.



REVISED


Preventive Care Services (continued)

Apr. 1, 2016 (Including Sterilizations): Updated lists of applicable

codes; added Code Group 5: - CPT codes 99211 and

99212 (IUD follow-up

visit)

- ICD-10 diagnosis code Z30.431

Updated preventive benefit instructions; added language to indicate a Code Group 5 CPT code is

considered preventive when billed with a listed Code Group 5 diagnosis code

Private Duty Nursing

Apr. 1, 2016

Updated benefit considerations: o Removed product specific

benefit exclusion/exception language

o Added language to indicate: Refer to the Member's

specific health benefit plan/summary of benefits, or state contractual

language to determine if the plan has exclusion for Private Duty Nursing

If the plan has the exclusion for private duty nursing

then the services are not eligible for coverage

Revised coverage rationale; removed language pertaining to precertification requirements and benefit coverage guidelines (refer to the Conditions of Coverage section of the policy for applicable

details)

Requirements for Coverage The services being requested must meet all of the following:

1. Be ordered and directed by the treating practitioner or specialist (M.D., D.O., P.A. or N.P), after a face to face evaluation by the physician, licensed or certified physician assistant or nurse practitioner; and

2. Services must be of Skilled Care in nature (Please see Skilled Care and Custodial Care Services policy and see Definitions section of this policy); and

3. A written treatment plan and a letter of medical necessity must be

submitted with the request for specific services and equipment. Periodic review of the written treatment plan may be required for continued Skilled Care needs and progress toward goals; and

4. Skilled Care services must be clinically appropriate and not more costly than an alternative health services; and

5. Services must be continuous and Skilled Care.(Please see Custodial and Skilled Services policy); and

6. The member’s condition requires continuous and/or frequent assessments and changes in the treatment; and

7. Meets the definition of Private Duty Nursing. Private duty nursing services are: o Skilled Care services o Continuous Skilled Care of greater than 4 hours per day

o Services provided in the home and not in a facility



REVISED


Private Duty Nursing (continued)

Apr. 1, 2016 Updated list of applicable codes: o Removed reference link to

policy titled Home Health Services

o Removed list of applicable

HCPCS modifiers

o Services that are not Custodial Care o The absence of an available care giver does not make the requested

services Skilled Care.

Plans may require the caregiver to provide a certain number of hours of care

for the patient. Check the enrollee specific plan documents or the state

contract. Coverage Limitations and Exclusions 1. Services beyond the plan benefits (hours or days). 2. Requested services are excluded in the plan documents or state specific

contracts.

3. Requested services are defined as non-skilled or custodial care in member’s plan specific documents (refer to Custodial and Skilled policy and plan specific documents).

4. Respite care and convenience care unless mandated. Respite care relieves the caregiver of the need to provide services to the patient. Services that can be provided safely and effectively by a non-clinically

trained person are not skilled when a non-skilled caregiver is not

available. 5. Services involving payment of family members or nonprofessional

caregivers for services performed for the member unless required by state mandate.

6. Services when enrollee does not meet criteria for Skilled Care services. 7. Member is no longer eligible for benefits under the plan.

Prosthetic Devices,

Wigs, Specialized, Microprocessor or Myoelectric Limbs

Apr. 1, 2016

Updated benefit considerations;

added language to indicate: o Before using this guideline,

please check the member

specific benefit document and any federal or state mandates, if applicable

Revised coverage rationale: o Updated coverage criteria for

prosthetic devices and wigs; added language to indicate prosthetic devices, when covered, regardless of the

I. Prosthetic Devices and Wigs

A determination of coverage for the prosthesis is based on the Member’s potential functional abilities. Potential functional ability is based on the

reasonable expectations of the prosthetist, and treating physician, considering factors including, but not limited to:

o The Member’s past history (including prior prosthetic use if applicable); and

o The Member’s current condition including the status of the residual limb and the nature of other medical problems.

1. Prosthetic device coverage is limited to those prosthetic devices that

replace limb or external body part that are listed below: Artificial arms, legs, feet and hands



REVISED


Prosthetic Devices, Wigs, Specialized, Microprocessor or Myoelectric Limbs (continued)

Apr. 1, 2016

setting or vendor from whom the prosthetic device is dispensed, are covered under the Prosthetic Devices section of the benefit document

o Updated list of applicable

coverage limitations and exclusions; added language to indicate coverage for wigs/scalp hair prosthesis is excluded unless specifically listed as a covered health

service Some states mandate

coverage; check the member specific benefit document for coverage

When wigs are covered, the

benefit does not include

coverage for hair implants or hair plugs

Artificial eyes, ears and nose Breast prosthesis as required by the Women’s Health and Cancer

Rights Act of 1998. Benefits include mastectomy bras and lymphedema stockings for the arm.

Speech aid prosthetics and tracheo-esophageal voice prosthesis.

Although these are typically external devices replacing the vocal

cords, there may be an intra-oral component. These devices are covered as either DME or Prosthetics. Please check the Member's certificate of coverage, summary of benefits, and/or health benefits plan documentation for coverage.

2. Prosthetic devices when covered, regardless of the setting or vendor from whom the prosthetic device is dispensed, are covered under the

Prosthetic Devices section of the benefit document. 3. Prosthetic devices must be ordered by or under the direction of a

physician. 4. The prosthetic device must be approved by the Food and Drug

Administration (FDA) and otherwise generally considered to be safe and effective for the purposes intended and the item must be

reasonable and necessary for the individual patient.

5. Breast prosthetics which include the breast prosthesis, mastectomy bra, and lymphedema arm stockings, are always covered on an unlimited basis as to number of items and dollar amounts covered as required by the Women’s Health and Cancer Act of 1998.

6. Implantable devices/prostheses, such as artificial heart valves, are not prosthetics. If covered, these devices would be covered as a

surgical service. 7. Coverage is available for repair and replacement, when it is not due

to misuse, malicious damage or gross neglect. 8. Several states mandate coverage for prosthetics. Please check the

Member's certificate of coverage, summary of benefits, and/or health benefits plan documentation for coverage.

II. Specialized, Microprocessor or Myoelectic Limbs

Computerized, bionic, microprocessor or myoelectric terms are considered the same for the purpose of this policy. Some states may require coverage of prosthetics that Oxford may not otherwise consider

covered.



REVISED



Apr. 1, 2016

Computerized or microprocessor limbs are based on a patient’s current functional capabilities and his/her expected functional rehabilitation potential. If more than one prosthetic limb meets a patient’s prosthetic rehabilitation needs, the least costly prosthetic will be approved.

Evidence is insufficient to permit conclusions regarding the effect of a

microprocessor-controlled prosthesis on health outcomes in limited community ambulators. Evidence is also insufficient to permit conclusions regarding the effect of a next-generation microprocessor-controlled prosthesis on health outcomes. Therefore, these are considered investigational.

1. Computerized Prosthetic limbs are a covered health service when criteria are met: a) Ordered by a physician; and b) Patient is evaluated for his/her individual needs by a healthcare

professional with the qualifications and training and under the supervision of the ordering physician to make an evaluation

(documentation should accompany the order); and

c) Ordering physician signs the final prosthetic proposal; and d) The records must document the patient’s current functional

capabilities and his/her expected functional rehabilitation potential, including an explanation for the difference, if that is the case. (It is recognized within the functional classification hierarchy that bilateral amputees often cannot be strictly bound

by functional level classifications); and e) Prosthetic replaces all or part of a missing limb; and f) Prosthetic will help patient regain or maintain function; and g) Patient is willing and able to participate in the training for the use

of the prosthetic (especially important in use of a computerized upper limb); and

h) Patient is able to physically function at a level necessary for a

computerized prosthetic or microprocessor, e.g., hand, leg or foot 2. Coverage of computerized and specialized lower limb prostheses is

based on maximum prosthetic function level of the patient (see Lower Limb Rehabilitation Classification Levels 1-4 under Definitions section of the policy) a) Patient meets criteria in #1 (one) above; and b) Patient has or is able to gain Lower Limb Rehabilitation



REVISED



Apr. 1, 2016

Classification Levels 3 or 4 for prosthetic ambulation (see Definitions section of the policy) A. Microprocessor or specialized foot or feet

Code Criteria

L5973 functional level is 3 or above







Note: A user adjustable heel height feature (L5990) will be denied as not meeting criteria for coverage.

B. Knees: Basic lower extremity prostheses include a single axis,

constant friction knee. Other prosthetic knees are indicated based upon functional classification.

Code Criteria

L5930 functional level is 4




L5722 – L5780 functional level is 3 or above


L5822-L5840 functional level is 3 or above





L5859

Meets all of the criteria below: Has a microprocessor (swing and stance

phase type (L5856)) controlled (electronic) knee

K3 functional level only Weight greater than 110 lbs. and less than



REVISED



Apr. 1, 2016

275 lbs. Has a documented comorbidity of the spine

and/or sound limb affecting hip extension and/or quadriceps function that impairs K-3

level function with the use of a microprocessor-controlled knee alone

Is able to make use of a product that requires daily charging.

Is able to understand and respond to error alerts and alarms indicating problems with the function of the unit

C. Ankles:

Code Criteria

L5982-L5986 Lower Limb Rehabilitation Classification is 2 or above.

L5973 Functional level is 3 or above






D. Sockets:

Code Criteria

L5618-L5628

More than 2 test (diagnostic) sockets for an individual prosthesis are not indicated unless

there is documentation in the medical record which justifies the need.

L5654-L5665

No more than two of the same socket inserts are allowed per individual prosthesis at the same time.

L5673 No more than two of the same socket inserts are allowed per individual prosthesis at the same time.



REVISED



Apr. 1, 2016




Exception: a test socket is not indicated for an immediate prosthesis (L5400-L5460)

Note: Socket replacements are indicated if there is adequate

documentation of functional and/or physiological need. It is recognized that there are situations where the explanation includes but is not limited to: changes in the residual limb; functional need

changes; or irreparable damage or wear/tear due to excessive patient weight or prosthetic demands of very active amputees.

3. Myoelectric Upper Limbs (arms, joints and hands) are covered when

criteria are met: a) Patient meets all the criteria in #1 (one) above; and b) Patient has a congenital missing or dysfunctional arm and/or

hand; or c) Patient has a traumatic or surgical amputation of the arm (above

or below the elbow); and

d) The remaining musculature of the arm(s) contains the minimum microvolt threshold to allow operation of a myoelectric prosthetic

device (usually 3-5 muscle groups must be activated to use a computerized arm/hand); and

e) A standard body-powered prosthetic device cannot be used or is insufficient to meet the functional needs of the individual in performing activities of daily living.

Coverage Limitations and Exclusions 1. Coverage for wigs/scalp hair prosthesis is excluded unless specifically

listed as a covered health service. Some states mandate coverage.



REVISED



Apr. 1, 2016

Check the members specific benefit document for coverage. When wigs are covered, the benefit does not include coverage for hair implants or hair plugs.

2. Coverage is not available for prosthetics if the patient is eligible through a governmental program for a prosthetic due to military service related

injuries and/or primary insurance coverage, e.g., VA, Medicare or

TriCare. 3. Replacement of prosthetic devices due to misuse, malicious damage or

gross neglect or to replace lost or stolen items (Check Member’s plan specific document).

4. Repairs to prosthetic devices due to misuse, malicious damage or gross neglect (Check Member’s plan specific document).

5. If more than one prosthetic device can meet the Member’s functional needs, benefits are only available for the prosthetic device that meets the minimum specifications for the Member’s needs. (Check Member’s plan specific document).

6. Coverage beyond any frequency limits specified in the Member’s plan specific documents. (Check Member’s plan specific document).

Radiology

Procedures Requiring Precertification for eviCore Healthcare Arrangement

Apr. 1, 2016 Revised coverage rationale:

o Updated Oxford Radiology Prior Notification/Authorization Crosswalk Table (list of codes that are interchangeable for prior authorization); added crosswalks for G0297, S8032, 71250, 72195, 74172, 78265

and 78266

Refer to the policy for complete details on Radiology Procedures Requiring

Precertification for eviCore Healthcare Arrangement.

Radiopharma-

ceuticals and Contrast Media

Apr. 1, 2016

Revised reimbursement

guidelines; added CPT codes 78265 and 78266 to list of procedure codes allowed with

A9541

eviCore Healthcare administers claims on behalf of Oxford Health Plans for

the following services that may be billed in conjunction with radiopharmaceuticals and/or contrast media: Radiology Services: Refer to Radiology Procedures Requiring

Precertification for eviCore Healthcare Arrangement for additional information.

Radiation Therapy Services: Refer to Radiation Therapy Procedures Requiring Precertification for eviCore Healthcare Arrangement for additional information.

Cardiology Services: Refer to Cardiology Procedures Requiring



REVISED


Radiopharma-ceuticals and Contrast Media (continued)

Apr. 1, 2016

Precertification for eviCore Healthcare Arrangement for additional information.

Reimbursement Guidelines MRI: Contrast agents billed with an MRI will be denied as “included in

the primary procedure”

PET Scans: Radiopharmaceutical billed with a PET scan will be denied as “included in the primary procedure”

CT or other radiographic study: Any code not on the list below or billed without a procedure code from the covered list below will deny as “included in the primary procedure”

Radiopharmaceuticals Billed in Conjunction with Nuclear Medicine Procedures eviCore Healthcare will reimburse for covered radioisotopes when used in conjunction with a nuclear medicine procedure. The radiopharmaceutical can be administered up to 96 hours before the primary procedure.

Covered services will be processed according to the chart below.

Code Code Description Allow with

Procedure Codes:

A9500 Technetium Tc-99m, Sestamibi, diagnostic, per study dose

78451-78454

78070-78072

78605-78607, 78800-78804

A9502 Technetium Tc-99m tetrofosmin, diagnostic, per study dose

78451-78454

78070-78072, 78803

A9503 Technetium Tc-99m, Medronate, (MDP), diagnostic, per study dose, up to 30 mCi's

78300-78320

A9505 Thallous Chloride TL-201, diagnostic, per mCi

78451-78454

78070-78072

78800-78804

78607



REVISED



Apr. 1, 2016

A9507 Indium IN 111 Capromab Pendetide (ProstaScintâ) per study dose, up to 10 mci's

78800-78804

A9508 Iobenguane sulfate-Metaiodobenzyl guanidine (MIBG) per 0.5 mCi

78075

78800-78804

A9509 Iodine I-123 Sodium Iodide, diagnostic, per millicurie

78000-78018,

78020, 78070-78072

A9510 Technetium Tc-99 Disofenin (Hepatolite DISIDA), per study dose, up to 15 mCi’s

78226, 78227

A9512 Technetium Tc-99m-Pertechnetate,

Diagnostic, per mCi

78012-78018

78600-78607, 78610

78481, 78483

78261

78290

78291

78070-78072

78230-78232

78730

78740

78630-78650

78660

78761

A9516 Iodine I-123 Sodium iodide capsule(s), Diagnostic per 100 Microcuries, up to 999 microcuries

78012-78018,78070-78072

A9521

Technetium Tc-99m Exametazine

(Ceretec ®), Diagnostic, per study dose, up to 25 mCi’s

78600-78607, 78610

A9524 Iodinated I-131-Serum Albumin, diagnostic, per 5 microcuries

78110-78111,

78122

78600-78607, 78610

78579-78598

78451-78454

78800-78804



REVISED



Apr. 1, 2016

78472-78473, 78481-78483

A9520 Technetium TC-99m, tilmanocept, diagnostic, up to 0.5 millicurie

78195

A9528 Iodine I-131 Sodium Iodide capsule(s),

Diagnostic, per mCi

78012-78018

78803

A9529 Iodine I-131 Sodium Iodide solution, Diagnostic, per mCi

78012-78018 78803

A9531 Iodine I-131 Sodium Iodide, Diagnostic, per microcurie (up to 100 microcuries)

78012-78018 78803

A9537 Technetium Tc-99m Mebrofenin (Choletec ®) Diagnostic, per study dose, up to 15 mCi's

78226, 78227

A9538

Technetium Tc-99m Pyrophosphate

(PYP) (Pyrolite ®) Diagnostic, per study dose, up to 25 mCi's

78300-78320

78466-78469

A9539 Technetium Tc-99m Pentetate, Diagnostic, per study dose, up to 25 mCi's

78579-78598

78761

78700-78725

78730

78740

78630-78650

78600-78607, 78610

78291, 78645

78481, 78483

78445

78428

A9540 Technetium Tc-99m Macroaggregated Albumin (MAA), Diagnostic, per study dose, up to 10 mCi’s

78579-78598

78291

78216, 78428

78201, 78205, 78215

78800, 78801, 78803

A9541 Technetium Tc-99m Sulfur Colloid, Diagnostic, per study dose, up to20

78201-78216

78185



REVISED



Apr. 1, 2016

mCi's 78278

78102-78104

78264, 78265, 78266

78258, 78262

78740

78730

78195

78291

A9542 Indium-IN-111 Ibritumomab Tiuxetan, Diagnostic, per study dose, up to 5 mCi's

78804

A9544 Iodine I-131 Tositumomab, (Bexxar ®) Diagnostic, per study dose

78804

A9547 Indium-IN-111 Oxyquinoline, Diagnostic, per 0.5 mCi

78805-78807, 78185

78190-78191

A9548 Indium IN-111 Pentetate (MyoScint ®) Diagnostic, per 0.5 mCi

78630, 78635, 78645,78647

78650

78800

A9551

Technetium Tc-99m Succimer (DMSA),

Diagnostic, per study dose, up to 10 mCi's

78700-78710

78800-78804

A9553 Chromium CR-51 Sodium Chromate, Diagnostic, per study dose, up to 250 microcuries

78120-78122

78130-78135, 78140

78190-78191

A9554

Iodine-125 Sodium Iothalamate (Glofil-

125 ®), Diagnostic, per study dose, up to 10 microcuries

78707-78709, 78725

A9556 Gallium Ga-67 Citrate, Diagnostic, per mCi

78800-78807

A9557 Technetium Tc-99m Bicisate (Neurolite ®), Diagnostic, per study dose, up to 25 mCi's

78600-78607, 78610

A9558 Xenon Xe-133 Gas, Diagnostic, per 10

mCi’s 78579-78598



REVISED



Apr. 1, 2016

A9560

Technetium Tc-99m Labeled Red Blood

Cell's (RBC's) Diagnostic, per study dose, up to 30 mCi’s (Ultra Tag ® or cold pyrophosphate (pyp) +99m

technetium)

78472, 78473, 78494, 78496

78278

78201-78206

78445

78457-78458

78215, 78216, 78185

A9561 Technetium Tc-99m Oxidronate, Diagnostic, per study dose, up to 30 mCi's

78300-78320

A9562

Technetium Tc-99m Mertiatide (MAG-3),

diagnostic, per study dose, up to 15 mCi's

78700-78725

A9567 Technetium Tc-99m Pentetate, Diagnostic, aerosol, per study dose, up to 75 mCi’s

78579-78598

A9569 Technetium TC-99m Exametazime labeled autologous white blood cells, Diagnostic, per study dose

78805-78807

A9570 Indium-111 labeled autologous white blood cells, diagnostic, per study dose

78805-78807, 78185

A9571 Indium in-111 labeled autologous platelets, diagnostic, per study dose

78190-78191

A9572 Indium-111 Pentetreotide (OctreoScan ®), Diagnostic, per study dose, up to 6 millicuries

78075, 78800-78804, 78015-78018

A9582

Iodine i-123 Iobenguane, diagnostic, per

study dose, up to 15 millicuries AdreView ®)

78075

78800-78804

Shoulder Replacement Surgery

(Arthroplasty)

Apr. 1, 2016


Care Guidelines, 19th edition,

2015” with “MCG™ Care Guidelines, 20th edition, 2016” (effective Apr. 1, 2016); refer

For information regarding medical necessity review, see: MCG™ Care Guidelines, 20th edition, 2016, Shoulder Arthroplasty, S-634

(ISC).

MCG™ Care Guidelines, 20th edition, 2016, Shoulder Hemiarthroplasty, S-633 (ISC).



REVISED


Shoulder Replacement Surgery (Arthroplasty) (continued)

Apr. 1, 2016 to 20th edition for complete details on applicable updates to the MCG™ Care Guidelines

Specialty Medication Administration - Site of Care Review Guidelines

Apr. 1, 2016

Revised coverage rationale; replaced reference to “MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016” (effective Apr.

1, 2016)

Introduction This policy addresses the criteria for consideration of allowing hospital outpatient facility specialty medication infusion services. This includes claim submission for hospital based services with the following CMS/AMA Place of Service codes:

22 On Campus - Outpatient Hospital; and 19 Off Campus - 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®) 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



REVISED


Specialty Medication Administration - Site of Care Review Guidelines

(continued)

Apr. 1, 2016 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, 20th edition, 2016, Home Infusion Therapy, CMT: CMT-

0009(SR).

Surgical Treatment for Spine Pain

Apr. 1, 2016


Care Guidelines, 19th edition, 2015” with “MCG™ Care

Guidelines, 20th edition, 2016” (effective Apr. 1, 2016); refer

to 20th edition for complete details on applicable updates to the MCG™ Care Guidelines

Spinal fusion using extreme lateral interbody fusion (XLIF) or direct lateral interbody fusion (DLIF) is proven and medically necessary. Coding Clarification

The North American Spine Society (NASS) recommends that anterior or anterolateral approach techniques performed via an open approach

should be billed with CPT codes 22554 – 22585. These codes should be used to report the use of extreme lateral interbody fusion (XLIF) and direct lateral interbody fusion (DLIF) procedures (NASS, 2010).

Laparoscopic approaches should be billed with an unlisted procedure code.

For information regarding medical necessity review, see the following MCG™ Care Guidelines, 20th edition, 2016:



REVISED


Surgical Treatment for Spine Pain (continued)

Apr. 1, 2016

Cervical Diskectomy or Microdiskectomy, Foraminotomy, Laminotomy, S-310 (ISC)

Lumbar Diskectomy, Foraminotomy, or Laminotomy S-810 (ISC) Cervical Laminectomy S-340 (ISC) Lumbar Laminectomy S-830 (ISC)

Cervical Fusion, Anterior S-320 (ISC)

Cervical Fusion, Posterior S-330 (ISC) Lumbar Fusion S-820 (ISC) The following spinal procedures are unproven and not medically necessary: A. Spinal fusion when performed via the following methods:

1. Laparoscopic anterior lumbar interbody fusion (LALIF) 2. Transforaminal lumbar interbody fusion (TLIF) which utilizes

only endoscopy visualization (such as a percutaneous incision with video visualization)

3. Axial lumbar interbody fusion (AxiaLIF) 4. Interlaminar lumbar instrumented fusion ( ILIF)

This includes interbody cages, screws and pedicle screw fixation devices with any of the above procedures. Clinical evidence is limited primarily to retrospective studies and case series. Randomized, controlled trials comparing these procedures to standard procedures are needed to determine impact on health

outcomes and long-term efficacy.

B. Spinal Decompression and Interspinous Process Decompression Systems

1. Interspinous process decompression (IPD) systems for the treatment of spinal stenosis

2. Minimally invasive lumbar decompression (MILD®)

Current clinical evidence is insufficient to permit conclusions about whether any beneficial effect from minimally invasive lumbar decompression provides a significant advantage over surgical decompression. In addition, the complication rates and reoperation rates for this procedure compared with those of decompression surgery is unknown.



REVISED


Surgical Treatment for Spine Pain (continued)

Apr. 1, 2016 C. Spinal Stabilization

1. Stabilization systems for the treatment of degenerative spondylolisthesis.

2. Total facet joint arthroplasty, including facetectomy,

laminectomy, foraminotomy, vertebral column fixation

The current published evidence is insufficient to determine whether facet arthroplasty is as effective or as safe as spinal fusion, the current standard for surgical treatment of degenerative disc disease. In addition, no devices have received approval from the U.S. Food and Drug Administration for use outside the clinical trial setting.

3. Percutaneous sacral augmentation (sacroplasty) with or

without a balloon or bone cement for the treatment of back pain. The available clinical evidence shows that percutaneous sacroplasty, may alleviate the pain and functional impairment of sacral insufficiency fractures (SIF) in most patients with few and predominantly minor adverse effects, suggesting that this procedure may be relatively safe and efficacious for treatment of SIF. Despite

these promising findings, the overall quality of the body of evidence

is low given that the available studies were limited by methodological flaws (e.g., retrospective design, small sample size, subjective outcome measures, lack of a control group, and inadequate follow-up). Before reliable recommendations may be made, higher-quality studies are required that entail large populations with sufficient statistical power.

D. Stand-alone facet fusion without an accompanying

decompressive procedure. This includes procedures performed with or without bone grafting and/or the use of posterior intrafacet implants such

as fixation systems, facet screw systems or anti-migration dowels. Clinical evidence is limited primarily to case series and nonrandomized studies. Randomized, controlled trials comparing facet fusion to standard

procedures are needed to determine impact on health outcomes and long-term efficacy.

Temporomandibular Joint Disorders

Apr. 1, 2016

Added reference link to policy titled Supply Policy

Revised coverage rationale; replaced reference to “MCG™ Care

The following services are proven and medically necessary for treating disorders of the temporomandibular joint (TMJ): Arthrocentesis Arthroplasty [For information regarding medical necessity review, when



REVISED


Temporomandibular Joint Disorders (continued)

Apr. 1, 2016

Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016” (effective Apr. 1, 2016)

applicable, see MCG™ Care Guidelines, 20th edition, 2016, Temporomandibular Joint Arthroplasty, ACG: A-0523 (AC)]

Arthroscopy (with or without FDA approved bone anchor devices) Arthrotomy/open joint surgery (with or without FDA approved bone

anchor devices)

Injections of corticosteroids for rheumatoid arthritis-related TMJ disorders

Physical therapy Stabilization and repositioning splint therapy (This does not include low-

load prolonged-duration stretch (LLPS) devices discussed below) Partial or total joint replacement with an artificial prosthesis is proven and medically necessary for treating disorders of the

temporomandibular joint (TMJ) when all other treatments have failed. Not all services treat all TMJ disorders; specific treatments are based upon the specific diagnosis.

The following services are unproven and not medically necessary for

treating disorders of the temporomandibular joint (TMJ): Biofeedback Craniosacral manipulation Passive rehabilitation therapy Low-load prolonged-duration stretch (LLPS) devices

There are limited studies evaluating biofeedback for the treatment of musculoskeletal pain, including TMJ pain. One small uncontrolled study reported positive effects, while a larger randomized controlled study failed to demonstrate any treatment effect.

Well-designed randomized, blinded and placebo-controlled outcome studies published on craniosacral manipulation for TMJ are not available. For

additional information regarding manipulation under anesthesia for TMJ disorders, see the policy titled Manipulation Under Anesthesia. While there are some data from several randomized trials and case series studies that certain types of passive rehabilitation techniques may improve jaw mobility early in recovery in patients who have undergone TMJ surgery, or have lost jaw mobility due to TMJ derangement or to contracture



REVISED


Temporomandibular Joint Disorders (continued)

Apr. 1, 2016 following radiation therapy, these studies all included very small numbers of patients, and did not provide blinded assessment of outcomes, long-term follow-up, or information on optimal treatment protocols. Further prospective controlled clinical trials that directly compare LLPS

devices to other treatment modalities are needed.

Total Knee Replacement Surgery (Arthroplasty)

Apr. 1, 2016 Changed policy title; previously titled Knee Replacement Surgery (Arthroplasty)

Revised coverage rationale; replaced reference to “MCG™ Care Guidelines, 19th edition, 2015”

with “MCG™ Care Guidelines, 20th edition, 2016” (effective Apr. 1, 2016)

For information regarding medical necessity review, see MCG™ Care Guidelines, 20th edition, 2016, Knee Arthroplasty, S-700 (ISC).

Vaccines

Apr. 1, 2016


o Replaced language indicating “Oxford provides coverage for

immunizations/vaccinations except where specifically excluded” with “the standard Oxford Certificate of Coverage covers preventive health services, including immunizations, administered in

a physician office” o Added language to indicate:

Implementation of FDA

approvals/Advisory Committee on Immunization Practices (ACIP)

recommendations will typically occur within 60 days after publication in the Centers for Disease Control and Prevention (CDC) Morbidity & Mortality Weekly

The standard Oxford Certificate of Coverage covers preventive health

services, including immunizations, administered in a physician office. Some immunizations are excluded, e.g., immunizations that are required for

travel, employment, education, insurance, marriage, adoption, military service, or other administrative reasons. Immunizations that are not classified as a "coverage exclusion" by the Member's plan are considered covered after all of the following conditions are satisfied: 1. US Food and Drug Administration (FDA) approval; and

2. Advisory Committee on Immunization Practices (ACIP) definitive ("shall") recommendation rather a permissive ("may") recommendation published in the Morbidity & Mortality Weekly Report (MMWR) of the Centers for

Disease Control and Prevention (CDC). Implementation will typically occur within 60 days after publication in the

MMWR. Please also refer to the policy titled Preventive Care Services for additional information on immunizations/vaccinations.



REVISED


Vaccines (continued)

Apr. 1, 2016 Report (MMWR) Refer to the policy titled

Preventive Care Services for additional information on immunizations/vaccinations

Revised benefit considerations:

o Removed reference to the CDC web site for information regarding the use of vaccines and immunizations in the United States

o Removed language pertaining

to benefit coverage guidelines Removed lists of applicable

CPT/HCPCS codes

Wearable Cardioverter-

Defibrillators

Apr. 1, 2016

Revised coverage rationale; modified list of applicable MCG™

Care Guidelines (effective Apr. 1, 2016): o Added new/additional

reference to applicable MCG™ Care Guidelines, 20th edition, 2016

o Replaced existing reference to

“MCG™ Care Guidelines, 19th edition, 2015” with “MCG™ Care Guidelines, 20th edition, 2016”; refer to 20th edition for complete details on applicable

updates to the MCG™ Care Guidelines

For information regarding medical necessity review of wearable cardioverter defibrillators, when applicable, see MCG™ Care Guidelines, 20th edition,

2016. Cardioverter-Defibrillator, Wearable ACG: A-0566 (AC). Also see related MCG™ Care Guidelines, 20th edition, 2016. Electrophysiologic Study and Implantable Cardioverter-Defibrillator (ICD) Insertion, Transvenous. ORG: M-157 (ISC).



UPDATED

Policy Title Effective Date Summary of Changes Administrative Guidelines

Behavioral Health Services

Mar. 1, 2016

Updated procedures and responsibilities/reimbursement guidelines for New York providers: o Added reimbursement rate for

Licensed Psychoanalyst

(PSYS): 65%

Reimbursement for covered behavioral health services varies by provider type. The following grid lists each provider type and the percentage of applicable fee(s) at which reimbursement will be made for Oxford Legacy participating providers as well as providers that do not participate with the health plan.

Exception: For New Jersey small and individual plans/products, out-of-network providers will be reimbursed at the 80th percentile of Prevailing Healthcare Charges System (PHCS).

State Provider Type Abbreviation Reimbursement Rate

CT

Doctor of Osteopathy DO 100%

Medical Doctor MD 100%

Physician Assistant PA 75%

Licensed Psychologist LP 75%

Licensed Clinical Social Worker

LCSW 65%

Licensed Marriage and Family Therapist

LMFT 65%

Licensed Professional Counselor

LPC 65%

Advanced Practice Registered Nurse

APRN 75%

Registered Nurse RN 75%

Licensed Alcohol & Drug Counselor

LADC No individual

reimbursement allowed.

BCBA Certification BCBA Cert

Refer to Autism additional information

on coverage for Applied

Behavioral Analysis for the diagnosis and

treatment of Autism Spectrum Disorder.



UPDATED


Behavioral Health Services (continued)

Mar. 1, 2016

NJ Doctor of Osteopathy DO 100%




Licensed Clinical Social

Worker LCSW

65%

Licensed Marriage and

Family Therapist LMFT

65%

Licensed Professional

Counselor LPC

65%

Advanced Practice Nurse APN 75%

Registered Nurse RN 75%

BCBA Certification BCBA Cert

Refer to Autism

additional information

on coverage for Applied Behavioral Analysis for

the diagnosis and treatment of Autism Spectrum Disorder.

NY

Doctor of Osteopathy DO 100%




Licensed Clinical Social Worker

LCSW 65%

Licensed Marriage and Family Therapist

LMFT 65%

Licensed Mental Health Counselor

LMHC 65%

Nurse Practitioner NP 75%



UPDATED


Behavioral Health Services (continued)

Mar. 1, 2016 NY Registered Nurse RN 75%

Licensed Behavior Analyst LBA

Refer to Autism additional information

on coverage for Applied Behavioral Analysis for

the diagnosis and treatment of Autism

Spectrum Disorder.

Licensed Psychoanalyst PSYS 65%

New York Participating Provider Laboratory & Pathology Protocol

Mar. 1, 2016

Updated Laboratory & Pathology Services Consent Form (English) attachment/reference document

The following procedures and responsibilities apply when a participating provider is treating a member enrolled in a New York (NY) product.

A. Participating Provider Using Participating

Laboratories/Pathologists:

Participating providers are required to use an Oxford Participating

laboratory and/or an Oxford participating pathologist when collecting specimens in their office. If a participating laboratory or pathologist is used, the Laboratory & Pathology Services Consent Form is not required.

If a participating provider is unable to locate a participating laboratory or

pathologist, they must contact Oxford for assistance.

B. Participating Provider Responsibilities

Specific guidelines must be followed if a Participating provider is recommending the use of, making a referral to or involving a non-

participating laboratory or pathologist in a member’s care. This includes

the following: o Specimens collected in the physician’s office for processing by a non-

participating provider (on and off-site). o Providing the member with a requisition form, prescription or other

form to obtain laboratory or pathology services outside the physician office.

Prior to making the recommendation, involving or referring a member to a non-participating laboratory or pathologist, the Participating provider is required to:

https://www.oxhp.com/secure/policy/autism.pdf



UPDATED



(continued)

Mar. 1, 2016

1. Verbally discuss options and financial impact with the member. a. The provider must review this policy and the Laboratory &

Pathology Services Consent Form with the Member. i. The discussion must explain participating alternatives and the

reason for any referral to a non-participating laboratory or

pathologist.

ii. The discussion must include a conversation explaining the financial impact of using a non-participating lab or pathologist. Refer to the Coordinate the Member’s Care as directed by the Member section below for details.

iii. A copy of the completed and signed Laboratory & Pathology Services Consent Form must be provided to the member.

b. The discussion must occur prior to the performance of any laboratory or pathology services including specimen collection.

c. The discussion must then be noted in the Member’s medical record.

2. Obtain a Completed Laboratory & Pathology Services Consent Form:

a. The member will need to make a choice whether to use a

participating or non-participating laboratory or pathologist, by marking their selected choice, signing and dating the Laboratory & Pathology Services Consent Form.

b. If the member: i. Does Agree to the use of a non-participating laboratory or

pathologist, refer to the Coordinate the Member’s Care as

directed by the Member (bullet 3a) for additional details. ii. Does Not Agree, refer to the Coordinate the Member’s Care as

directed by the Member (bullet 3b) for additional details. c. The signed and completed Laboratory & Pathology Services Consent

Form must be kept on file by the Participating provider. d. A separate Laboratory & Pathology Services Consent Form is

required for each episode of laboratory care when the Participating

provider wants to refer to or involve a non-participating laboratory or pathologist in a member’s care.

e. The Laboratory & Pathology Services Consent Form will only be valid for 15 days from the date of member signature.

f. Oxford may request a copy of the completed Laboratory & Pathology Services Consent Form from the Participating provider in order to conduct standard business.



UPDATED



(continued)

Mar. 1, 2016

i. When requested, the Participating provider must provide a copy of the Laboratory & Pathology Services Consent Form within 15 days of the request.

ii. If a copy of the signed and completed Laboratory & Pathology Services Consent Form is not received within 15 days of the

request, the claim for the Evaluation & Management (E&M)

service, from the office visit that generated the non-participating laboratory or pathology service will be reversed and denied administratively for failure to comply with this protocol.

iii. Any payment previously made for the E&M service will be subject to recovery. In these instances, the Participating

provider is prohibited from balance billing the member.

3. Coordinate the Member’s Care as Directed by the Member in the Laboratory & Pathology Services Consent Form a. If the Member agrees to the use of Non-participating

Laboratory or Pathologist:

Ensure that the member understands the financial obligations of

using a non-participating laboratory or pathologist. - For Members with out of network benefits: Non-

participating laboratory and pathology claims will be paid at the out-of-network benefit level. Out-of-network cost shares and deductibles will apply. In addition, members may be responsible to the non-participating laboratory or

pathologist for any amount above the amount paid by the health plan, as determined by the member’s out-of-network benefit; OR

- For Members with only in-network benefits: Non-

participating laboratory and pathology claims will be denied because the member has no coverage for services provided by non-participating providers. Members will therefore be

responsible for the entire cost of the service(s). b. If the Member does NOT agree to the use of Non-

participating Laboratory or Pathologist: If the participating provider is unable to locate a participating

laboratory or pathologist, they must contact Oxford for assistance in locating one.

If the participating provider still wants to recommend the non-



UPDATED



(continued)

Mar. 1, 2016 participating laboratory or pathologist, they must contact the health plan to request and initiate an in-Network Exception.

C. Financial Consequence for Non-Compliance by NY Participating

Physicians

Oxford may request a copy of the completed Laboratory & Pathology Services Consent Form from the Participating provider (who is required to keep the form on file) in order to conduct standard business. o When requested, the Participating physician must provide a copy of

the Laboratory & Pathology Services Consent Form within 15 days of the request.

o If a copy of the completed Laboratory & Pathology Services Consent Form is not received within 15 days of the request, the Evaluation & Management (E&M) code from the office visit, which generated the non-participating laboratory or pathology referral, will be reversed and denied administratively for failure to comply with this protocol.

o Any payment previously made for the E&M service will be subject to

recovery. In these instances, the Participating provider is prohibited

from balance billing the member.

Speech Therapy and Early Intervention

Programs/Birth to Three

Mar. 1, 2016 Updated coverage rationale for Early Intervention Program/Birth to Three; replaced reference to

“Department of Mental Retardation (DMR)” with “Office of Early Childhood”

Refer to the policy for complete details on the coverage guidelines for Speech Therapy and Early Intervention Programs/Birth to Three.

REVISED


Autism

Apr. 1, 2016

Revised benefit

considerations/mandated coverage requirements for Connecticut (CT) plan

members to indicate:

o All Members: Coverage must

be provided for physical therapy, speech language and

Refer to the policy for complete details on the coverage guidelines for

treatment of Autism.



REVISED


Autism (continued)

Apr. 1, 2016

pathology services, and occupational therapy services for the treatment of autism spectrum disorders; visit limits cannot be applied to these

services

o For members with plan years on or after Jan. 1, 2016 under the age of 21: In addition to the coverage mentioned above, these members must also be

provided coverage for medically necessary behavioral interventions based on the principles of applied behavioral analysis and related structured behavioral

programs, as prescribed

through a treatment plan o For members with plan

years prior to Jan 1. 2016 under the age of 15: In addition to the coverage mentioned above, these

members must also be provided coverage for medically necessary behavioral interventions based

on the principles of applied behavioral analysis and related structured behavioral

programs, as prescribed through a treatment plan

Revised coverage rationale for applied behavioral analysis (ABA) therapy for CT plan members; updated coverage criterion pertaining to age requirement to



REVISED


Autism (continued)

Apr. 1, 2016 indicate: o For members with plan

years prior to Jan. 1, 2016: The patient's age is 15 years or less

o For members with plan

years new or renewing on or after Jan. 1, 2016: The patient’s age is 21 years or less

Updated definition of “applied behavioral analysis (ABA)” for CT

plan members

Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical

Supplies, and Repairs/ Replacements

Apr. 1, 2016

Revised coverage rationale: o Updated indications for

coverage: Added guideline to indicate

there are specific codes defined by HCPCS as orthotics that Oxford covers as DME

Replaced guideline indicating “Pleurx bottles and tubing are covered as

DME” with “Pleurx bottles and tubing are covered as supplies”

Updated guideline for ventilators; replaced

reference to HCPCS code E0464 (expired

12/31/2015) with E0466 o Modified list of coverage

limitations and exclusions; added language to indicate batteries are excluded unless specifically stated as covered

in the enrollee specific benefit

Refer to the policy for complete details on the coverage guidelines for Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies, and Repairs/Replacements.



REVISED


Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies, and

Repairs/

Replacements (continued)

Apr. 1, 2016 document Updated definitions; added

definition of “mobility device”

Orthopedic Services

Apr. 1, 2016

Revised coverage rationale; replaced reference to “MCG™ Care Guidelines, 19th edition,

2015” with “MCG™ Care Guidelines, 20th edition, 2016” (effective Apr. 1, 2016)

Oxford covers medically necessary acute care services and post-acute 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, 20th edition, 2016 (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 for a list of ICD-9 codes) are subject to utilization review with OrthoNet’s orthopedic division. Acute Care Hospital

Ambulatory Surgery Center



REVISED


Orthopedic Services (continued)

Apr. 1, 2016 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: Meets the applicable guideline(s)/medical criteria, an Orthonet

Case Manager may make a utilization review decision (with oversight by a 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.



REVISED


Timeframe Standards for Utilization Management (UM) Initial Decisions

Apr. 1, 2016 Revised notification guidelines for pre-service, con-current (on-going course of treatment), urgent con-current (on-going course of treatment) and urgent

request types for New York

plan members; added language to indicate: o Effective for groups new or

renewing on or after Apr. 1, 2016: Determinations for any

request for court ordered mental health and or substance use disorder services must be made by telephone within 72 hours of receipt of the request

Written notice of the

determination to the member or member’s designee shall follow within 3 business days

Refer to the policy for complete details on Timeframe Standards for Utilization Management (UM) Initial Decisions.

RETIRED/REPLACED

Policy Title Effective Date Summary of Changes

Medical Supplies Mar. 1, 2016 Policy retired; refer to the policies titled Supply Policy and Durable Medical Equipment, Orthotics, Ostomy Supplies, Medical Supplies, and Repairs/Replacements for applicable coverage guidelines for medical supplies



NEW

Policy Title Effective Date Reimbursement Guidelines

Physical Medicine & Rehabilitation: Multiple Therapy Procedure Reduction Policy

Apr. 1, 2016*

*Notice of Implementation Delay: The following reimbursement guidelines will not be effective on Mar. 1, 2016 as previously announced; implementation of the new policy has been postponed until Apr. 1, 2016. Reimbursement

Consistent with CMS, Oxford ranks all reimbursable procedures from the Multiple Therapy Reducible Codes list

(procedures with indicator 5 in the Multiple Procedure Payment Reduction [MPPR] field on the CMS National Physician Fee Schedule) that are provided on a single date of service. The primary procedure is reimbursed without

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.

Code

Allowable

Amount

Prior to

Reduction

PE

RVU

Total

RVU

Portion of charge

attributable to

Practice Expense

(PE RVU/

Total RVU)

Ranking Comments Final Allowable Amount

Multiple Therapy

Reducible Code A

$31.60 .45 .79 56% 3 PE value = 56% of $31.60 or $17.70. $17.70 is reduced by 50% or $8.85.



NEW


Physical Medicine & Rehabilitation: Multiple Therapy Procedure Reduction Policy

(continued)

Apr. 1, 2016 Allowable Amount = $31.60 - $8.85 or $22.75.

Multiple Therapy

Reducible Code B

$40.40 .36 1.01 35% 4 PE value = 35% of $40.40 or $14.14. $14.14 is reduced by 50% or $7.07. Allowable Amount = $40.40 - $7.07 or $33.33.

Multiple Therapy

Reducible Code C

$36.40 .45 .91 49% 2 Because Codes A and C have the same PE

RVUs, the Total RVUs are used to further rank

these two procedures.

PE value = 49% of $36.40 or $17.84. $17.84 is reduced by 50% or $8.92. Allowable Amount = $36.40 - $8.92 or $27.48.

Multiple Therapy

Reducible Code D

$96.80 1.05 2.42 43% 1 Primary procedure (highest PE value) is not subject to reduction

$96.80

For a list of codes that are subject to the Multiple Therapy Reduction policy (including the assigned Practice Expense RVU, Total RVU and ratio of Practice Expense to Total RVU for each code) refer to the Multiple Therapy Reducible Codes list.

Replacement Codes

Apr. 1, 2016

Per the public use file that accompanies the NPFS Relative Value File, the following is stated for status code “I”: Not

valid for Medicare purposes. Medicare uses another code for reporting of, and payment for, these services.

In certain instances CMS creates Healthcare Common Procedure Coding System (HCPCS) replacement codes for physicians and/or healthcare professionals to report in lieu of the Current Procedural Terminology (CPT®) or HCPCS codes assigned an “I” status. The replacement codes allow for additional code specificity so that the appropriate reimbursement and beneficiary coverage can be applied for the service provided.

In the example below CMS has replaced intraoperative neurophysiology CPT code 95941 with HCPCS code G0453 which is specific to a single beneficiary.



NEW


Replacement Codes (continued)

Apr. 1, 2016 Note: RVU values may not accurately reflect the current NPFS and are intended for illustrative purposes only.

NPFS status Code Description RVU

I = Not valid for Medicare purposes

95941 Continuous intraoperative neurophysiology monitoring, from outside the operating room (remote or nearby) or for monitoring of more than one case while in the

operating room, per hour (List separately in addition to code for primary procedure)

0.00

A = Active Code G0453 Continuous intraoperative neurophysiology monitoring,

from outside the operating room (remote or nearby), per patient, (attention directed exclusively to one patient) each 15 minutes (list in addition to primary procedure)

0.93

Consistent with CMS, Oxford will not separately reimburse for specific CPT or HCPCS codes assigned a status code

“I” on the NPFS Relative Value File, indicating another code (replacement code) is used to report the procedure or service and that replacement code has an assigned RVU. Codes from the NPFS with a status of “I” addressed in other Oxford reimbursement policies, codes with no identified replacement code and those where the replacement

code does not have an RVU are not included in this policy.

\

UPDATED

Policy Title Effective Date Summary of Changes Reimbursement Guidelines

After Hours and Weekend Care

Policy

Mar. 1, 2016

Routine review; no content changes

The Centers for Medicare and Medicaid Services (CMS) considers reimbursement for Current Procedural Terminology (CPT®) codes 99050,

99051, 99053, 99056, 99058 and 99060 to be bundled into payment for other services not specified. Oxford, however, will provide additional compensation to physicians for seeing patients in situations that would otherwise require more costly urgent care or emergency room settings by reimbursing CPT code 99050 in addition

to basic service codes.

CPT Code 99050 Oxford will reimburse after hours CPT code 99050 when reported with basic services in one of the following CMS non-facility place of service (POS) designations only:

POS Code Description

03 School



UPDATED


After Hours and Weekend Care Policy (continued)

Mar. 1, 2016

05 Indian Health Service Free-Standing Facility

07 Tribal 638 Free-Standing Facility

11 Office

49 Independent Clinic

50 Federally Qualified Health Center

71 State or Local Public Health Clinic

72 Rural Health Clinic

CPT Codes 99051, 99053, 99056, 99058 or 99060 Consistent with CMS and with the intent of this policy, Oxford will not

separately reimburse CPT codes 99051, 99053, 99056, 99058 or 99060.

Increased Procedural Services

Mar. 1, 2016


Oxford's standard for additional reimbursement of Modifier 22 (increased procedural services) and/or Modifier 63 (procedures performed on infants less than 4 kg) is 20% of the Allowable Amount for the unmodified procedure, not to exceed the billed charges. Claims submitted with these

modifiers must include medical record documentation which supports the use

of the modifiers and which will be reviewed by Oxford in accordance with this policy.

Note: When both modifier 22 and modifier 63 are appended to the same CPT code, reimbursement will be a total of an additional 20% of the Allowable Amount of the unmodified procedure, not to exceed the billed charges, provided the documentation supports use of either Modifier 22 or Modifier 63. Refer to the Obstetrical Policy for information on the use of Modifier 22 with obstetrical services.

Modifier 22 - Increased Procedural Services In order to be considered for additional reimbursement when reporting

Modifier 22, thorough medical records or reports and a separate document containing a concise statement about how the service differed from the usual service or procedure is required. The documents must indicate the substantial additional work performed and the reason for the additional work

which may include, but not be limited to, increased intensity or time, technical difficulty of procedure that is not described by a more comprehensive procedure code, severity of the patient’s condition, or increased physical and mental effort required. Additional reimbursement will only be considered for services appended with



UPDATED


Increased Procedural Services (continued)

Mar. 1, 2016 Modifier 22 that are assigned a global period of 0, 10, 42 or 90 days. Modifier 22 should not be appended to an evaluation and management service. Refer to the “Global Days Policy” for a listing of those codes with a global day period.

Modifier 63 - Procedure Performed on Infants less than 4 kg

In order to be considered for additional reimbursement when reporting Modifier 63, thorough medical record(s) or report(s) that support the use of the modifier is required. The document(s) must indicate the substantial

additional work performed and the reason for the additional work which may include, but not be limited to, increased intensity or time, technical difficulty of procedure that is not described by a more comprehensive procedure code, severity of the patient’s condition, or increased physical and mental effort required.

Unless otherwise designated, this modifier may only be appended to procedures/services listed in the 20005-69990 code series. Modifier 63 should not be appended to any CPT code listed in the Evaluation and

Management Services, Anesthesia, Radiology, Pathology/Laboratory, or

Medicine sections.

Modifier SU Policy

Mar. 1, 2016


The Centers for Medicare and Medicaid Services (CMS) indicates that the Health Care Common Procedure Coding System (HCPCS) modifier SU, Procedure performed in physician's office (to denote use of facility and equipment), is not payable unless a provider’s contract states otherwise. CMS establishes Relative Value Units (RVU) for CPT and HCPCS codes that include the costs of running an office (such as rent, equipment, supplies and

non-physician staff costs) which are referred to as the practice expense RVU. In accordance with CMS, Oxford does not allow reimbursement for services appended with modifier SU in an office place of service unless a provider's contract states otherwise, since the use of the office facility and

equipment is included in the practice expense RVU, or the costs associated with operating an office.

If the charges associated with the use of the modifier SU are submitted by a different provider than the physician performing the office procedure, they will not be considered for separate reimbursement since these practice expenses are considered included in the reimbursement for the physician performing the service.



UPDATED


Nonphysician Health Care Codes Policy

Mar. 1, 2016


The American Medical Association Current Procedural Terminology (CPT®) Professional Edition gives the following instruction for code selection: “Select the name of the procedure or service that accurately identifies the service performed. Do not select a CPT code that merely approximates the service provided.”

The American Medical Association (AMA) has developed specific CPT codes intended for use by qualified health care professionals who are not Physicians to report their services. In some instances the intended use of a procedure or service is within the description of the code. For example CPT 98960 describes education and training for patient self-management by a qualified, nonphysician health care professional. In other instances the AMA has

included parenthetical information in the CPT book as with CPT 96040 which says “These services are provided by trained genetic counselors and may include obtaining a structured family genetic history, pedigree construction, analysis for genetic risk assessment, and counseling of the patient and family.”

Conversely, the AMA instructs Physicians who provide genetic counseling and

education, risk factor reduction intervention or medical nutrition therapy to use the appropriate evaluation and management codes to report these services. Existing evaluation and management codes include services such as taking a patient’s health and family history and counseling. Therefore, in accordance with correct coding guidelines, Oxford will not

reimburse nonphysician health care professional service codes (CPT 96040, 96150-96155, 97802-97804, 98960-98962 or HCPCS G0270-G0271) when reported by a Physician, because these codes are intended for use by nonphysician health care professionals. Physicians who provide genetic

counseling, health and behavior assessment/intervention, medical nutrition therapy or education and training for patient self-management should report these services using evaluation and management codes.

Observation Care and Evaluation and Management Codes

Mar. 1, 2016

Updated policy application language to indicate this policy applies to all network and non-network physicians and other qualified health care professionals, including, but not

Initial Observation Care The physician supervising the care of the patient designated as "observation status" is the only physician who can report an Observation Care CPT code (99218-99220). It is not necessary that the patient be located in an observation area designated by the hospital, although in order to report the Observation Care codes the physician must:



UPDATED


Observation Care and Evaluation and Management Codes (continued)

Mar. 1, 2016

limited to, non-network authorized and percent of charge contract physicians and other qualified health care professionals

Updated definition of “same

specialty physician or other qualified health care professional”; replaced reference to “other health care professionals” with “other qualified health care

professionals”

Indicate in the patient's medical record that the patient is designated or admitted as observation status;

Clearly document the reason for the patient to be admitted to observation status; and

Initiate the observations status, assess, establish and supervise the care

plan for observation and perform periodic reassessments.

The CPT codebook states that "When "observation status" is initiated in the course of an encounter in another site of service (e.g., hospital emergency department, office, nursing facility) all evaluation and management services provided by the supervising physician or other qualified health care professional in conjunction with initiating "observation status" are considered

part of the initial observation care when performed on the same date. The observation care level of service reported by the supervising physician should include the services related to initiating "observation status" provided in the other sites of services as well as in the observation setting." Oxford follows the Centers for Medicare and Medicaid Services' (CMS) Claims

Processing Manual which provides the instructions, "for a physician to bill the

initial observation care codes [99218-99220], there must be a medical observation record for the patient which contains dated and timed physician's admitting orders regarding the care the patient is to receive while in observation, nursing notes, and progress notes prepared by the physician while the patient was in observation status. This record must be in addition to any record prepared as a result of an emergency department or outpatient

clinic encounter." Consistent with CMS guidelines, Oxford requires that an Initial Observation Care CPT code (99218-99220) should be reported for a patient admitted to

observation care for less than 8 hours on the same calendar date. Subsequent Observation Care

In the instance that a patient is held in observation status for more than two calendar dates, the supervising physician should utilize a subsequent observation care CPT code (99224 - 99226). Physicians other than the supervising physician providing care to a patient designated as "observation status" should report subsequent observation care. According to the CPT codebook, “All levels of subsequent observation care



UPDATED



Mar. 1, 2016

include reviewing the medical record and reviewing the results of diagnostic studies and changes in the patient's status (i.e., changes in history, physical conditions, and response to management) since the last assessment.” Observation Care Discharge Services

Per CPT, Observation Care discharge day management CPT code 99217

"includes final examination of the patient, discussion of the hospital stay, instructions for continuing care and preparation of discharge records." Observation Care discharge services include all E/M services on the date of discharge from observation services and should only be reported if the discharge from observation status is on a date other than the date of initial

Observation Care. Oxford follows CMS guidelines that physicians should not report an Observation Care discharge Service when the Observation Care is a minimum of 8 hours and less than 24 hours and the patient is discharged on the same calendar date.

Observation Care Admission and Discharge Services on Same Date Physicians who admit a patient to Observation Care for a minimum of 8 hours, but less than 24 hours and subsequently discharge on the same calendar date shall report an Observation or Inpatient Care Service (Including Admission and Discharge Services) CPT code (99234-99236).

In accordance with CMS' Claims Processing Manual, when reporting an observation care admission and discharge service CPT code (99234-99236) the medical record must include: Documentation meeting the E/M requirements for history, examination

and medical decision making; Documentation stating the stay for hospital treatment or observation care

status involves 8 hours but less than 24 hours;

Documentation identifying the billing physician was present and personally performed the services; and

Documentation identifying that the admission and discharge notes were written by the billing physician.

Observation Care Services During a Surgical Period Observation care codes are not separately reimbursable services when



UPDATED



Mar. 1, 2016

performed within the assigned global period as these codes are included in the global package. Refer to the policy titled Global Days for guidelines on reporting services during a global period.

Once in a Lifetime Procedures

Mar. 1, 2016


Oxford will reimburse certain procedures only once during a patient’s lifetime. Once in a Lifetime Procedures are not limited to a single CPT code, but may be represented by Code Families, which are a group of CPT codes

that describe the same or similar type of service. Under this policy, Oxford provides reimbursement for only one procedure from a designated Code Family during a patient’s lifetime.

For example, there are four separate appendectomy CPT codes that can be used, based upon the particular circumstance, to report the removal of the appendix. The four codes, listed below, make up the Code Family that describes the removal of an appendix.

Appendectomy Code Family 44950: Appendectomy

44955: Appendectomy; when done for indicated purpose at time of other major procedure (not as separate procedure) (List separately in addition to code for primary procedure)

44960: Appendectomy; for ruptured appendix with abscess or generalized peritonitis

44970: Laparoscopy, surgical, appendectomy

When any single or multiple physician or other health care professional reports a code from the Once in a Lifetime Procedures, that code or any code from the same Code Family will be reimbursed only once during a patient’s lifetime. In the appendectomy example, a single code from the

Appendectomy Code Family will be reimbursed only once during a patient’s lifetime, because each person has only one appendix and can have only one appendectomy during his or her lifetime. Refer to the “Attachment” section of the policy for a complete list of Once in a Lifetime Procedures, listed by CPT code and Code Family.

Modifiers There may be situations that require the code(s) for a Once in a Lifetime



UPDATED


Once in a Lifetime Procedures (continued)

Mar. 1, 2016 Procedure to be submitted more than once during a patient’s lifetime. In such cases, more than one Once in a Lifetime Procedure, whether the same code or a different code from the same Code Family will be considered separately for reimbursement if reported with one of the following modifiers: Modifier 53 - Discontinued Procedure

Modifier 55 - Postoperative Management Only

Modifier 56 - Preoperative Management Only Modifier 58 - Staged or Related Procedure or Service by the Same

Physician

For additional information related to the percentage of the allowable fee to be paid when one of these modifiers is appended to a claim for a subsequent

procedure, please refer to the Discontinued Procedure, Split Surgical Package and/or Global Days policies.

Standby Services

Mar. 1, 2016

Updated policy overview; modified language pertaining to

CPT code definition for 99360 to indicate this code used to report physician or other qualified health care professional standby services that are requested by another individual that involves prolonged attendance without

direct (face-to-face) patient contact

Centers for Medicare and Medicaid Services The Centers for Medicare and Medicaid Services (CMS) does not reimburse

for physician standby services. These services are considered by CMS to be included in the payment to a facility as part of providing quality care and are not separately reimbursable. Standby Services In accordance with CMS, Oxford does not reimburse physician or other qualified health care professional standby services submitted with CPT code

99360. If a specific service is directly rendered to the patient by the standby physician or other qualified health care professional (i.e., tissue examination of frozen section biopsy), the service or procedure would be reported under the appropriate CPT code (i.e., 88331).

Mandated Hospital On Call Service Oxford does not reimburse for hospital mandated on call services billed under

CPT codes 99026 and 99027 because they do not involve direct patient contact.

T Status Codes

Mar. 1, 2016


Per the public use file that accompanies the NPFS Relative Value File, the following is stated for status indicator "T":

"There are RVUs and payment amounts for these services, but they are only paid if there are no other services payable under the physician fee schedule



UPDATED


T Status Codes (continued)

Mar. 1, 2016 billed on the same date by the same provider. If any other services payable under the physician fee schedule are billed on the same date by the same provider, these services are bundled into the physician services for which payment is made."

Consistent with CMS, Oxford considers Current Procedural Terminology

(CPT®) and Healthcare Common Procedural Coding System (HCPCS) codes with a status indicator of T bundled into any other service provided, on the same date by the Same Individual Physician, Hospital, Ambulatory Surgical Center or Other Health Care Professional, for which payment is made. No modifier overrides will exempt T status codes from bundling into the services for which payment is made.

In the case of two T status codes being billed together with no other service, on the same date of service by the Same Individual Physician, Hospital, Ambulatory Surgical Center or Other Health Care Professional, Oxford will bundle the code with the lower relative value unit (RVU) into the code with the higher RVU.

REVISED


Maximum Frequency Per Day

Apr. 1, 2016

Updated policy application guidelines; added language to indicate this policy does not apply to: o Network physicians and other

qualified health care

professionals contracted at a case rate (in some markets

known as a flat rate) unless the code description for the service or supply indicates it should be reported only once daily or has a Medically

Unlikely Edits Adjudication Indicator (MAI) of 2

Revised reimbursement guidelines:

MFD Determination: Part I The following criteria are first used to determine the MFD values for codes to which these criteria are applicable: The service is classified as bilateral (CMS Indicators 1 or 3) on the

Centers for Medicare & Medicaid Services (CMS) National Physician Fee Schedule (NPFS) or the term 'bilateral' is included in the code descriptor.

For the majority of these codes, the MFD value is 1. There are some codes that describe more than one anatomical site or vertebral level that

can be treated bilaterally where the MFD value may be more than 1. Where the CPT or HCPCS code description/verbiage references reporting

the code once per day, the MFD value is 1. The service is anatomically or clinically limited with regard to the number

of times it may be performed, in which case the MFD value is established

at that value. The CPT or HCPCS code description/verbiage indicates the number of

times the service can be performed, in which case the MFD value is set at that value.



REVISED


Maximum Frequency Per Day (continued)

Apr. 1, 2016

o Added language pertaining to Medically Unlikely Edit Adjudication Indicator (MAI) 2 to indicate: CMS has identified

CPT/HCPCS codes where

the units of service (UOS) on the same date of service in excess of the MUE value would be considered impossible because it is contrary to statute,

regulation or sub-regulatory guidance

Oxford will not allow units in excess of the MFD value to be reimbursed for CPT/HCPCS codes assigned

an MAI indicator of “2”; no

modifier will be allowed nor will the MFD value be overridden by supplying documentation for adjustment requests

o Added reference link to the

CMS Medically Unlikely Edits (MUE) file

CMS Durable Medical Equipment Medicare Administrative Contractor (DMEMAC) Local Coverage Determination (LCD) assigns an MFD value in which case the MFD value is set at that value.

Where the criteria above have not defined an MFD value, the CMS Medically Unlikely Edits (MUE) value, where available, will be utilized to

establish an MFD value.

Where no other definitive value has been established based on the criteria above, drug HCPCS codes will have an MFD value of 999 which indicates they are exempt from the MFD policy.

Where no other definitive value has been established based on the criteria above, unlisted CPT and HCPCS codes will have an MFD value of 999 which indicates they are exempt from the MFD policy.

Where no other definitive value has been established based on the criteria above, new CPT codes released by the American Medical Association and new HCPCS codes released by CMS since the last MFD value update (not covered by any of the above criteria), will have an MFD value of 100.

MFD Determination: Part II

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



REVISED



Apr. 1, 2016

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 HCPCS codes to be submitted with multiple units. However, when reporting the same CPT or HCPCS code on multiple and/or separate claim lines, the 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.

Medically Unlikely Edit Adjudication Indicator (MAI) 2 CMS has identified CPT/HCPCS codes where the units of service (UOS) on the same date of service in excess of the MUE value would be considered impossible because it is contrary to statute, regulation or sub-regulatory guidance. Therefore, Oxford will not allow units in excess of the MFD value



REVISED



Apr. 1, 2016

to be reimbursed for CPT/HCPCS codes assigned an MAI indicator of “2”. Per CMS guidelines, no modifier override will be allowed nor will the MFD value be overridden by supplying documentation for adjustment requests.

CMS Medically Unlikely Edits (MUE) File

Modifiers

Modifier Modifier Description

59

Distinct Procedural Service Under certain circumstances, it may be necessary to indicate

that a procedure or service was distinct or independent from other non-E/M services performed on the same day. Modifier 59 is used to identify procedures or services, other than E/M services, that are not normally reported together but are 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.

76

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. 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



REVISED



Apr. 1, 2016

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.

91

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, 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 result is all that is required. This modifier may not be used when other code(s) describe a series of test results (eg, glucose 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.

XE Separate Encounter A service that is distinct because it occurred during a separate encounter.

XS Separate Structure A service that is distinct because it was performed on a separate organ/structure.

XU

Unusual Non-Overlapping Service

The use of a service that is distinct because it does not overlap usual components of the main service.

Anatomic Modifiers

Modifier Modifier Description

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



REVISED



Apr. 1, 2016

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

RI Ramus intermedius coronary artery

RT Right side

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

Apr. 1, 2016

Revised list of Procedures that include Moderate Sedation Codes 99143-99145 (attachment file

detailing procedures that do not allow separate reimbursement for

moderate sedation CPT codes 99143-99145): o Added 0394T, 0395T, 0424T,

0425T, 0426T, 0427T, 0428T, 0429T, 0430T, 0431T, 0432T, 0433T, 0434T, 0435T, 0436T, 43210, 45399, 61645, 77767,

Attending Physician (99143-99145) Oxford will allow separate reimbursement for Moderate Sedation services reported as CPT codes 99143-99145 when provided by the Same Physician,

hospital, ambulatory surgical center, or other qualified health care professional reporting the diagnostic or therapeutic procedure except when

reported with: 1. Procedures listed in Appendix G of the CPT book 2. Anesthesia procedures (CPT codes 00100-01999) 3. CPT and HCPCS codes that are part of CMS NCCI edits These procedures include Moderate Sedation as an inherent part of providing



REVISED


Moderate Sedation (continued)

Apr. 1, 2016

77768, 77770, 77771 and 77772

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 supports), should be reported as CPT codes 99148-99150. Reimbursement of 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



REVISED


Moderate Sedation (continued)

Apr. 1, 2016

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 in a location other than inpatient/outpatient hospital, emergency room or 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.

Obstetrical Policy Apr. 1, 2016 Revised reimbursement guidelines; added CPT codes 99415 and 99416 to list of prolonged physician services that are not separately reimbursable

for labor and delivery

Refer to the Obstetrical Policy for complete details on applicable reimbursement guidelines.

mm/01/2016: oxford® policy update bulletin: month 2016

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