PRN (Policy, Review & News) August 2014 · PRN 8/2014 2 nervous, radiology, urology, as well as hospital care, preventive care and newborn care visits.These changes may also affect

Centers for Medicare and Medicaid Services is adopting a non-coverage

position for tumor treatment field therapy ............................................................ 3

Correction June 2014 PRN: Medical criteria for arthrocentesis or needling

of a bursa and trigger point injections .................................................................. 3

Skin allergy testing coverage criteria expanded to include eosinophilic

esophagitis ............................................................................................................ 85

Criteria revised for diagnosis and treatment of obstructive sleep apnea

in adults ................................................................................................................. 90

UCR and Premier Blue Shield reimbursement changes approved

The Pennsylvania Insurance Department has approved Highmark Blue Cross Blue Shield’s request to

adjust UCR Level II and Premier Blue Shield reimbursements. These adjustments impact anesthesia,

select surgical, diagnostic, and evaluative services including, but not limited to, integumentary, digestive,

PRN Policy Review & News

Important information about Highmark Blue Cross Blue Shield

www.highmarkbcbs.com August 2014

Look for this

symbol for all

Medicare

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information

MA

In This Issue

News

Note: This publication may contain certain administrative requirements, policies, procedures, or other similar requirements of Highmark Inc. (or changes thereto)

which are binding upon Highmark Inc. and its contracted providers. Pursuant to their contract, Highmark Inc. and such providers must comply with

any requirements included herein unless and until such item(s) are subsequently modified in whole or in part.

Highmark Blue Cross Blue Shield and Keystone Health Plan West are independent licensees of the Blue Cross and Blue Shield Association, an association of

independent Blue Cross and Blue Shield Plans. Blue Cross Blue Shield and the Cross and Shield symbols are registered service marks of the Blue Cross and Blue Shield Association.

Security Blue, Premier Blue, and Freedom Blue are service marks of the Blue Cross and Blue Shield Association Highmark is a registered mark of Highmark Inc.

http://www.highmarkbcbs.com/

PRN 8/2014

2

nervous, radiology, urology, as well as hospital care, preventive care and newborn care visits. These

changes may also affect the Western Region Managed Care (KHPW) fee schedules.

Highmark plans to implement these fee adjustments for dates of service on or after Oct. 1, 2014.

As mentioned in the June 2014 PRN, Highmark is continuing the process started last year, of combining

the Premier Blue Shield and Western Region managed Care fee schedules into one statewide fee

schedule.

The new statewide fee schedule will serve as a platform for Highmark’s Pay for Value (P4V)

reimbursement models. Therefore, Highmark’s annual professional fee adjustment process is

transitioning, channeling the majority of additional reimbursement through these developing P4V primary

care and specialist programs.

Fees available via NaviNet

When the adjustments are in effect on Oct. 1, 2014, you may access the reimbursement adjustment

information online in these convenient ways:

Visit the Provider Resource Center through NaviNet®. Simply hover on Administrative

Reference Materials, and click on Fee Updates to view the complete list of fee adjustments. (Fees

are not published on the public Provider Resource Center.)

When the adjustments are in effect, you can also use these online tools:

On NaviNet, hover on Allowance, then select Allowance Inquiry to determine pricing for specific

procedure codes by plan or product type.

Also on NaviNet, you can hover on Allowance, and select Frequently Billed Codes. This function

initiates a report request that provides you with a quicker means of retrieving the most frequently

billed codes or procedure codes based on the specialty represented by the selected billing provider

and plan.

Via NaviNet’s Resource Center, you can download the full Western Region Managed Care

(KHPW) and/or Premier Blue Shield fee schedule. Simply click on Administrative Reference

Materials, and you’ll find the links on the bottom half of the page.

If your practice does not have NaviNet access, please contact your Provider Relations representative for

assistance.

PRN 8/2014

3

Centers for Medicare and Medicaid Services is adopting a non-

coverage position for tumor treatment field therapy

Centers for Medicare and Medicaid Services (CMS) is adopting a non-coverage position for tumor

treatment field therapy (TTFT).

Tumor treatment field therapy (E0766) will be denied as not medically necessary.

For additional information, refer to Medicare Advantage Medical Policy E-77, Tumor Treatment Field

Therapy (TTFT).

Correction June 2014 PRN: Medical criteria for arthrocentesis or

needling of a bursa and trigger point injections

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will consider arthrocentesis or needling of a

bursa and trigger point injections as approved when clinical criteria is met.

Arthrocentesis or needling of a bursa

Arthrocentesis or needling of a bursa may be considered medically necessary when ALL of the following

criteria are met:

Conservative therapy (rest area and avoid activity, cryotherapy, compression dressings, elevation

of affected area above heart, other modalities like electrical

stimulation/ultrasonography/phonophoresis, NSAIDs, or corticosteroid injections) to control pain

and inflammation has failed, and

Affected area continues with symptoms of severe pain along with swelling and inflammation, and

Movement of joint remains limited due to pain, and

The response to therapy must be documented for medical review prior to additional therapy

authorizations.

Trigger point injections

Trigger point injections (TPI) with a local anesthetic with or without steroid may be considered medically

necessary when ALL of the following general and specific criteria are met:

Review

PRN 8/2014

4

General criteria

There is a regional pain complaint; and

A neurological, orthopedic or musculoskeletal system evaluation ,which includes the member's

description of pain as it relates to location, quality, severity, duration, timing, context, and

modifying factors, followed by a physical examination of associated signs and symptoms; and

Conservative therapy (for example, physical or chiropractic therapy, oral analgesia, steroids,

relaxants or activity modification) fails or is not feasible; and

When necessary to facilitate mobilization and return to activities of daily living, an aggressive

regimen of physical therapy or other therapeutic modalities; and

The response to therapy must be documented for medical review prior to additional therapy

authorizations.

Specific criteria

Pain complaint or altered sensation in the expected distribution of referred pain from a trigger

point; and

Taut band palpable in an accessible muscle when the trigger point is myofascial; and

Exquisite spot tenderness at one point along the length of the taut band when the pain is

myofascial; and

Some degree of restricted range of motion of the involved muscle or joint, when measurable; and

The above specific criteria are associated with at least ONE of the following MINOR CRITERIA:

o Reproduction of clinical pain complaint or altered sensation by pressure on the tender

spot; or

o Local response (twitch) elicited by snapping palpation at the tender spot or by needle

insertion into the tender spot; or

o Pain alleviation by elongating (stretching) the muscle or by injecting the tender spot.

Trigger point injections (TPI) with a local anesthetic with or without steroid may be considered medically

necessary for the treatment of pain associated with fibromyalgia when ALL of the American College of

Rheumatology diagnostic criteria for fibromyalgia are met. These are:

History of widespread pain for at least 3 months. To be considered wide spread, the pain must be

present on both right and left sides and both above and below the waist. In addition, axial skeletal

pain (cervical spine or anterior chest or thoracic spine or low back) must be present. In this

definition, shoulder and buttock pain is considered as pain for each involved side. "Low back

pain" is considered lower segment pain, and

Pain, on digital palpation, must be present in at least 11 of the following 18 sites:

PRN 8/2014

5

o Occiput: Bilateral, at the suboccipital muscle insertions;

o Low cervical: bilateral, at the anterior aspects of the intertransverse spaces at C5-C7;

o Trapezius: bilateral, at the midpoint of the upper border;

o Supraspinatus: bilateral, at origins, above the scapula spine near the medial border;

o Second rib: bilateral, at the second costochondral junctions, just lateral to the junctions on

upper surfaces;

o Lateral epicondyle: bilateral, 2 cm distal to the epicondyles;

o Gluteal: bilateral, in upper outer quadrants of buttocks in anterior fold of muscle;

o Greater trochanter: bilateral, posterior to the trochanteric prominence;

o Knee: bilateral, at the medial fat pad proximal to the joint line

TPI Schedule

The following schedule for trigger point injections may be considered medically necessary when the

previous criteria are met:

In the diagnostic or stabilization phase, individuals may receive injections at intervals of no

sooner than one week and preferably two weeks. The number of trigger point injections should be

limited to no more than four (4) times per year for the diagnostic or stabilization phase.

In the treatment or therapeutic phase, trigger point injections should continue only if the previous

diagnostic injections provided pain relief and the frequency should be two (2) months or longer

between each injection. The previous injections should have provided at least greater than 50%

relief of pain for a period of at least six (6) weeks. The injections should be repeated only as

necessary based on the medical necessity criteria (see above) and these should be limited to a

maximum of six (6) times for local anesthetic and steroid injection.

Under unusual circumstances such as a recurrent injury or cervicogenic headache, trigger point

injections may be repeated at intervals of six (6) weeks after stabilization in the treatment phase.

*Conservative therapy will be considered “a failure of treatment” if no reduction or resolution of pain

within 6 weeks.

Not medically necessary

Trigger point injections are considered not medically necessary in the presence of:

Systemic infections;

Bleeding tendencies (including individuals undergoing anticoagulation therapy);

Other concomitant unstable medical conditions.

PRN 8/2014

6

"Dry needling" trigger point stimulation is considered not medically necessary. There is little evidence to

support dry needling. Studies of dry needling for lower back pain found that while dry-needling may be a

useful adjunct to other therapies; most of the limited numbers of studies available were of low

methodological quality and small sample size.

Please refer to Medical Policy S-31 for more information.

Highmark Blue Cross Blue Shield’s medical policy guidelines for all of its medical-surgical and Medicare

Advantage products are available online in the Provider Resource Center through NaviNet®

or at

www.highmarkbcbs.com. An alphabetical, as well as a sectional index, is available on the Medical Policy page.

You can search for a medical policy by entering a key word, policy number, or procedure code.

In PRN, the Medicare Advantage icon indicates Medicare Advantage medical policy-related information.

Place of service designation included on additional medical policies

Highmark Blue Cross Blue Shield is including place of service designation on the following medical

policies:

Policy # Policy Topic Place of Service Effective Date

A-1* Anesthesia Provided in Conjunction with

Non-Covered Services

Outpatient 10/27/2014

I-19* Intravenous Antibiotic Therapy for Lyme

Disease

Outpatient 10/27/2014

I-73* Docetaxele (Taxotere®) Outpatient 10/27/2014

I-74* Pemetrexed (Alima®) Outpatient 10/27/2014

I-89* Carboplatin (Paraplatin®) Outpatient 10/27/2014

L-38* VeriStrat® Assay Outpatient 10/27/2014

L-102* Urine Drug Testing (UDT) Outpatient 10/27/2014

L-104* KRAS Mutation Analysis Outpatient 10/27/2014

M-31* Cardiac Event Detection Monitoring Outpatient 10/27/2014

MA

Policy


PRN 8/2014

7

Policy # Policy Topic Place of Service Effective Date

S-88* Ilizarov Bone Lengthening Inpatient/Outpatient

(Revised)

10/27/2014

Y-22* Opioid Dependence Therapy Outpatient 10/27/2014

* Typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in

special circumstances including, but not limited to the presence of a co-morbid condition that would

require monitoring in a more controlled environment such as the inpatient setting.

Policies on KRAS mutation analysis will be combined

Effective Oct. 27, 2014, a new policy on KRAS mutation analysis will become effective with the

following criteria:

KRAS mutation analysis in metastatic colorectal cancer

The use of KRAS mutation analysis (81275) is covered for predicting nonresponse to anti-epidermal

growth factor receptor (EGFR) monoclonal antibodies cetuximab (J9055)(Erbitux®, ImClone Systems)

and panitumumab (J9303)(Vectibix™, Amgen) in the treatment of metastatic colorectal cancer.

KRAS mutation analysis for non-small cell lung cancer

The use of Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation analysis (81275) is covered

to predict non-response to erlotinib (Tarceva) in the treatment of non-small cell lung cancer (NSCLC) in

patients:

Who are currently or have a history of tobacco use (i.e., more than 100 cigarettes in lifetime)

AND

Diagnosed with a mucin rich-secreting type of adenocarcinoma, as defined by the 2004 WHO

classification, when at least 10% of the entire tumor overtly shows a mucin-producing neoplastic

component.

o Mucin-rich secreting type adenocarcinomas include:

mucinous-type bronchioloalveolar carcinoma (BAC)

colloid adenocarcinoma

signet-ring cell carcinoma

mucoepidermoid carcinoma

solid with mucu type adenocarcinoma

PRN 8/2014

8

mixed aciner adenocarcinoma with mucinous type BAC

Analysis of somatic mutations of the KRAS gene is considered experimental/investigational to predict

non-response to erlotinib (Tarceva) in the treatment of non-small cell lung cancer (NSCLC) in patients

who do not meet the criteria above. A participating, preferred, or network provider can bill the member

for the denied test.

KRAS mutation analysis is considered experimental/investigational for all diagnoses other than non-small

cell lung cancer, colorectal cancer. A participating, preferred, or network provider can bill the member for

the denied test.

KRAS mutation analysis in fine needle aspirates of the thyroid

KRAS mutation analysis of fine needle aspirates (FNA) of the thyroid that are cytologically indeterminate

has a high positive predictive value for malignancy. However, patients with an equivocal FNA result

would likely proceed to surgery regardless of mutation status, with intraoperative consultation to guide

the necessity and extent of surgery. Mutation analysis does not achieve a high enough negative predictive

value to identify which patients can undergo watchful waiting over thyroid surgery. Although the

presence of certain mutations may predict more aggressive malignancies, the clinical utility of identifying

these mutations preoperatively has not been established.

KRAS mutation analysis in fine-needle aspirates of the thyroid is considered to be

experimental/investigational. A participating, preferred, or network provider can bill the member for the

denied service.

Refer to Medical Policy L-103 for guidelines on KRAS and GNAS mutation analysis for pancreatic cyst.

Please refer to Medical Policy L-104 for more information.

Coverage criteria established for Veristrat® Assay

Beginning Oct. 27, 2014, Highmark Blue Cross Blue Shield coverage guidelines for proteomic assay,

VeriStrat® will become effective. The assay testing for advanced non-small cell lung cancer (NSCLC)

assists physicians to determine second-line treatment.

VeriStrat proteomic testing may be considered medically necessary for patients with advanced non-small

cell lung cancer (NSCLC) to determine second-line treatment when BOTH of the following criteria are

met:

PRN 8/2014

9

Failed previous first line doublet platinum-based therapy;

Initial genomic EGFR mutation testing is wild-type (no mutation detected) or unknown (e.g., if

tumor tissue might not be available for initial EGFR testing

All other uses of VeriStrat proteomic testing are considered experimental/investigational other than

advanced non-small cell lung cancer (NSCLC).

Note: It is expected that this test will be performed once per patient lifetime.


Criteria updated for automatic external defibrillators

Highmark Blue Cross Blue Shield is revising the coverage criteria for automatic external defibrillators.

Effective Oct. 27, 2014, the following guideline will be added to the existing criteria for automatic

external defibrillators.

As an alternative to an implantable cardioverter-defibrillator (ICD) in an individual who has a

documented contraindication to an ICD (e.g., systemic infection, lack of vascular access).

Procedure codes revised for automatic external defibrillators.

Services that do not meet the criteria of this policy will not be considered medically necessary. A

Pennsylvania participating, preferred or network provider cannot bill the member for the denied service

unless: (a) the provider has given advance written notice, informing the member that the service may be

deemed not medically necessary; (b) the member is provided with an estimate of the cost; and (c) the

member agrees in writing to assume financial responsibility in advance of receiving the service. The

signed agreement must be maintained in the provider’s records. Out of Network/Non-participating

providers and providers located outside of Pennsylvania may be able to bill members if the service is

denied.

Please refer to Medical Policy E-58 for more information.

Criteria revised for catheter ablation in the pulmonary veins

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will revise the criteria for catheter ablation in

the pulmonary veins as follows:

PRN 8/2014

10

Transcatheter radiofrequency ablation of arrhythmogenic foci in the pulmonary vein isolation for the

treatment of atrial fibrillation may be considered medically necessary when ALL of the following

indications are met:

Is symptomatic; and

Is resistant, intolerant, or has a contraindication to one (1) or more antiarrhythmic drugs

A Pennsylvania participating, preferred or network provider cannot bill the member for the denied service






denied.

Transcatheter cryoablation of arrhythmogenic foci in the pulmonary veins as a treatment of atrial

fibrillation is considered experimental/investigational. A participating, preferred, or network provider can

bill the member for the denied service.

Please refer to Medical Policy M-18 for more information.

Criteria expanded for cardiac event detection monitoring

Cardiac event detection monitoring (codes 93268, 93270, 93271, and 93272) may be considered

medically necessary when reported for the following conditions:

Palpitations;

Dizziness;

Syncope and collapse; and

Other transient symptoms which could be due to arrhythmia.

Payment will be allowed once in a thirty day period regardless of the number of events or recordings

which occurred. Charges billed more frequently within the thirty-day period are considered part of the

global allowance and are not eligible for separate reimbursement. A participating, preferred, or network

provider cannot bill the member separately for additional monitoring during the thirty-day period.

Claims reporting the use of a cardiac event recorder for more than 30 consecutive days in a 12 month

period of time should be referred for a medical necessity determination. An additional 30 consecutive

day’s use may be considered medically necessary in the following situations:

PRN 8/2014

11

After treatment has been initiated, the symptoms continue to occur;

No symptoms occurred during the initial 30 day use of the recorder.

Payment for conditions other than those listed above will be denied as not medically necessary. Also,

payment for additional use beyond 30 consecutive days can be made only if documentation (e.g., office

notes) can establish the medical need for the frequency.

Required Documentation: The individual's medical record must reflect the medical necessity for the care

provided. These medical records may include, but are not limited to: records from the professional

provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The use of long-term (greater than 48 hours) external ECG monitoring by continuous rhythm recording

and storage (e.g., Zio Patch)(codes 0295T-0298T) may be considered medically necessary for the

following:

Patients who experience infrequent symptoms (less frequently than every 48 hours) suggestive of

cardiac arrhythmias (i.e., palpitations, dizziness, presyncope, or syncope), or

Patients with atrial fibrillation who have been treated with catheter ablation, and in whom

discontinuation of systemic anticoagulation is being considered

Note: Do not report 0295T-0298T in conjunction with 93268-93272 for the same monitoring period.








denied.

See Medical Policy Bulletin M-11 for guidelines on the technical component for diagnostic services.

See Medical Policy Bulletin M-60 for a cardiac surveillance system that is automatically activated.

Please refer to Medical Policy M-31 for more information.

PRN 8/2014

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No longer paying for least costly orthosis

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will no longer be paying for a least costly

prefabricated orthosis when the medical necessity for a custom fabricated orthosis is not met. The custom

orthosis will be denied as not medically necessary.

There is no proven clinical benefit to the inflatable air bladder incorporated into the design of code L1847

or L1848; therefore, claims for codes L1847 or L1848 will be denied as not medically necessary instead

of allowing the least costly medically appropriate alternative, code L1831.

Payment will no longer be made for the least costly medically appropriate alternative, a prefabricated

orthosis, if the claim for a custom fabricated orthosis is not supported by a written order specifying

custom fabricated.

Payment will also no longer be made for the least costly alternative, L1831, if a custom fabricated knee

orthosis is used in the treatment of a contracture in a nonambulatory patient and the criterion for a

prefabricated knee orthosis with a locking joint is met.

A custom fabricated knee immobilizer without joints (L1834) is covered if criteria 1 and 2 below are met:

1. The coverage criteria for the prefabricated orthosis code L1830 are met; and

2. The general criterion for a custom fabricated orthosis is met.

If an L1834 orthosis is provided and both criteria 1 and 2 above are not met, the orthosis will be denied as

not medically necessary.

If an L1834 orthosis is provided and criterion 1 is met but criterion 2 is not met, payment will no longer

be based on the allowance for the least costly medically appropriate alternative, L1830.

A custom fabricated knee orthosis with an adjustable flexion and extension joint (L1844, L1846) is

covered if criteria 1 and 2 below are met:

1. The coverage criteria for the prefabricated orthosis codes L1843 and L1845 are met; and

2. The general criterion for a custom fabricated orthosis is met.

If an L1844 or L1846 orthosis is provided and both criteria 1 and 2 above are not met, the orthosis will be

denied as not medically necessary.

If an L1844 or L1846 orthosis is provided and criterion 1 is met but criterion 2 is not met, payment will

no longer be based on the allowance for the least costly medically appropriate alternative, L1843 or

L1845, respectively.

PRN 8/2014

13

Claims for prefabricated or custom-fabricated devices that contain a concentric adjustable torsion style

mechanism in the knee joint should be coded as E1810—dynamic adjustable knee extension/flexion

device includes soft interface material. All lines on claims billed with L-codes for devices incorporating a

concentric adjustable torsion style mechanism in the knee joint will be rejected as incorrect coding.

Claims for custom fitted orthoses (L1810, L1832, L1843, L1845 and L1847) will be denied as incorrect

coding, with a statutory denial, when documentation shows that only minimal self-adjustment was

required at the time of fitting.

Please refer to Medical Policy O-28 for more information.

Coverage criteria revised for pneumatic compression devices

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will revise the criteria on pneumatic

compression devices as follows:

Coverage for outpatient physical medicine and/or durable medical equipment (DME) is determined

according to individual or group customer benefits.

Pneumatic compression devices/lymphedema pumps and appliances may be covered as durable medical

equipment (DME) when ALL of the following are met:

When prescribed by a physician; and

Has appropriate physician oversight (i.e., physician evaluation of the patient's condition to

determine medical necessity of the device, suitable instruction in the operation of the machine as

to the pressure to be used and the frequency and duration of use, and ongoing monitoring of use

and response to treatment).

Segmented or non-segmented pneumatic compression devices without calibrated gradient pressure

(E0650, E0651) for home use may be considered necessary for the treatment of ANY ONE of the

following:

Lymphedema (pumps and appliances) of the arm or leg that has failed a four (4) week trial of

conservative therapy and the treating physician determines that there has been no significant

improvement or if significant symptoms remain after the trial. The trial of conservative therapy

must include ALL of the following:

o a compression bandage system or compression garment; and

o exercise; and

PRN 8/2014

14

o elevation of the limb.

OR

Chronic venous insufficiency (CVI) of the lower extremities with non-healing venous stasis

ulcer(s) after a six (6) month trial of conservative therapy directed by the treating physician. The

trial of conservative therapy must include ALL of the following:

o a compression bandage system or compression garment; and

o appropriate dressings for the wound; and

o exercise; and

o elevation of the limb.

OR

Prevention of post-thrombotic syndrome; or

Prevention of DVT following major orthopedic surgery (pump and appliances).

Segmented pneumatic compression therapy devices with calibrated gradient pressure (E0652) may be

considered medically necessary when the following medical necessity criteria are met:

The individual's medical condition has failed to respond to therapy using a segmented pneumatic

compressor without calibrated gradient pressure with clear documentation that the individual has

unique characteristics that prevent satisfactory pneumatic compression treatment using a non-

segmented device (E0650) with a segmented appliance/sleeve (E0671-E0673) or a segmented

device without manual control of the pressure in each chamber (E0651).

The treatment for lymphedema of the chest or trunk and for the treatment of arterial insufficiency is

considered experimental/investigational and is not eligible for reimbursement. Participating, preferred,

and network providers can bill the patient for the denied service.

When pneumatic compression devices are provided for conditions other than those listed, they will be

denied as not medically necessary. A Pennsylvania participating, preferred or network provider cannot

bill the member for the denied service unless: (a) the provider has given advance written notice,

informing the member that the service may be deemed not medically necessary; (b) the member is

provided with an estimate of the cost; and (c) the member agrees in writing to assume financial

responsibility in advance of receiving the service. The signed agreement must be maintained in the

provider’s records. Out of Network/Non-participating providers and providers located outside of

Pennsylvania may be able to bill members if the service is denied.


PRN 8/2014

15

Intravenous immune globulin criteria revised

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will revise the criteria on intravenous Immune

globulin as follows:

Preferred product(s)

J1561—Gamunex/Gamunex-C (Immune Globulin Intravenous [Human])

Non-preferred product(s)

In order for a request for a non-preferred immune globulin product to be approved, ANY ONE of the

following must be met:

The individual must have had an adequate therapeutic trial and experienced a documented drug

therapy failure with the preferred IG product(s); or

The individual is being treated with a non-preferred IG product for an indication for which the

non-preferred product is FDA-approved and the preferred product(s) is/are not FDA-approved; or

The individual is currently stable on a non-preferred IG product in such cases where the member

has previously experienced an intolerable adverse effect with another non-preferred IG product

and a change to a preferred IG product would be likely to cause the same intolerable adverse

effect due to similarities in individual product characteristics (e.g., IgA content, sugar content,

sodium content, concentration); or

The individual is therapy naïve, but whose clinical characteristics, as documented by objective

laboratory evidence (i.e., IgA level), would predispose them to significant adverse events

associated with the use of a preferred product; or

The individual is less than 18 years of age and is currently stable on a non-preferred product.

Individuals less than 18 years of age who are new to therapy will be required to start on a

preferred IG product unless criteria 2 or 4 are met above.

In the event that the preferred IG product(s) is/are not available due to a product shortage, authorization of

non-preferred products will be provided to members who require continued therapy.

An “adequate therapeutic trial” consists of using a preferred IG product at recommended doses for a

period of time adequate to assess therapeutic benefit (unless the patient experiences an intolerable adverse

effect due to drug therapy within that time period).

“Drug therapy failure” consists of not achieving the desired therapeutic goal, development of an

intolerable adverse effect due to drug therapy, or development of a hypersensitivity reaction to the drug

product. The length of therapy with the preferred product(s) and the reason(s) for drug therapy failure

should be documented.

PRN 8/2014

16

Intravenous immune globulin may be considered medically necessary for treatment of ANY ONE of the

following conditions below:

*FDA-labeled indications

Hematologic

Idiopathic thrombocytopenia purpura (ITP)

o treatment of acute, severe ITP defined by ANY ONE of the following parameters:

acute ITP with major bleeding, e.g., life-threatening bleeding and/or clinically

important mucocutaneous bleeding; or

acute ITP with severe thrombocytopenia and at high risk for bleeding

complications; or

acute ITP with severe thrombocytopenia and a slow or inadequate response to

corticosteroids; or

acute ITP with severe thrombocytopenia and a predictable risk of bleeding in the

future, e.g., a procedure or surgery with a high bleeding risk

OR

o treatment of chronic ITP*; in patients with ALL of the following:

duration of disease has been at least six (6) months; and

individual has persistent thrombocytopenia despite treatment with corticosteroids

and splenectomy

Warm antibody autoimmune hemolytic anemia, refractory to corticosteroids and

immunosuppressive agents

Severe anemia due to parvovirus B19

Neuroimmunological

CIDP (chronic inflammatory demyelinating polyneuropathy)*, in individuals with progressive

symptoms for at least two (2) months

Primary immune deficiency syndromes, including combined immunodeficiencies*

Treatment of primary immunodeficiencies, including Congenital agammaglobulinemia (total IgG

< 200 mg/dl)

Common variable immunodeficiency (hypogammaglobulinemia (total IgG < 400 mg/dl))

Severe combined immunodeficiency

Wiskott-Aldrich syndrome

X-linked agammaglobulinemia (total IgG < 200 mg/dl)

X-linked Hyper-IgM Syndrome

PRN 8/2014

17

Individuals with primary immunodeficiency syndromes should meet ALL of the following criteria for

treatment with IVIG:

Laboratory evidence of immunoglobulin deficiency; and

Persistent and severe infections despite treatment with prophylactic antibiotics; and

Documented inability to mount an adequate immunologic response to inciting antigens; and

o Lack of appropriate rise in antibody titer following provocation with a polysaccharide

antigen. For example, an adequate response to the pneumococcal vaccine may be defined

as at least a 4-fold increase in titers for at least 50% of serotypes tested; or

o Lack of appropriate rise in antibody titer following provocation with a protein antigen.

For example, an adequate response to tetanus/diphtheria vaccine may be defined as less

than a 4-fold rise in titers 3-4 weeks after vaccine administration.

Please refer to Medical Policy I-14 for more information.

Duration of IV antibiotic therapy for Lyme disease is clarified

Effective Oct. 27, 2014, the duration of IV antibiotic therapy for Lyme disease will be limited to four

weeks.

Coverage for intravenous antibiotic therapy for treatment of Lyme disease is determined according to

individual or group customer benefits. A two to four week course of intravenous antibiotic therapy may

be considered medically necessary for the following indications:

1. In patients with Lyme disease with objective neurologic complications of Lyme disease

associated with positive serologic and cerebral spinal fluid (CSF) findings.

Objective neurologic findings include:

Lymphocytic meningitis associated with CSF abnormalities;

Bell's palsy or other cranial neuropathy associated with CSF abnormalities;

Encephalitis or encephalomyelitis associated with CSF abnormalities;

Radiculopathy;

Polyneuropathy.

Positive serologic diagnosis is defined as BOTH criteria A and B below:

A. Positive or indeterminate ELISA test, as characterized by:

IgIG showing a titer greater than or equal to 800 (positive) or a titer between 1:200

and 1:400 (indeterminate); or

PRN 8/2014

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IgM ELISA test showing a titer of greater than or equal to 200 (positive) or 1:100

(indeterminate).

B. Positive immunoblot or Western blot, as characterized by:

2 of the 8 most common IgM antibody bands to spirochetal antigens are present; or

5 of the 10 most frequent IgG antibody bands are present.

Note: All positive or indeterminate ELISA tests must be confirmed with immunoblot.

Positive CSF findings include all of the following:

Pleocytosis; and

Evidence of intrathecal production of B. burgdorferi antibodies in CSF; and

Increased protein levels.

2. In patients with Lyme carditis, as evidenced by positive serologic findings (defined above) and

associated with a high degree of atrioventricular block or a PR interval of greater than 0.3

seconds.

3. In the small subset of patients with well-documented Lyme arthritis who have such severe

arthritis that it requires the rapid response associated with IV antibiotics.

Intravenous antibiotic therapy used in the treatment of Lyme disease for indications other than those

referenced above should be denied as not medically necessary and, therefore, not covered.

Intravenous antibiotic therapy, for the treatment of Lyme disease, beyond 28 days should be considered

not medically necessary and, therefore, not covered.








denied.


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Clinical criteria established for Mohs Micrographic Surgery

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will establish clinical criteria for Mohs

Micrographic Surgery (MMS). MMS may be considered medically necessary for the following:

Primary or recurrent basal cell carcinomas, squamous cell carcinomas, or basalosquamous cell

carcinomas in anatomic locations where they are prone to recur:

o Adenocystic carcinoma of the skin

o Adenoid type of squamous cell carcinoma

o Angiosarcoma of the skin

o Apocrine carcinoma of the skin

o Atypical fibroxanthoma

o Bowen's disease ( squamous cell carcinoma in situ)

o Bowenoid papulosis

o Dermatofibrosarcoma protuberans

o Erythroplasia of Queryrat

o Extramammary Paget's disease

o Keratoacanthoma

o Leiomyosarcoma or other spindle cell neoplasms of the skin

o Malignant fibrous histiocytoma

o Merkel cell carcinoma

o Microcystic adnexal carcinoma

o Oral and central facial, paranasal sinus neoplasm

o Sebaceous gland carcinoma

o Squamous cell carcinoma, rapid growth

o Verrucous carcinoma

o Laryngeal carcinomas

Aggressive pathology in the following areas:

o Hands and feet

o Genitalia

o Nail unit/periungual

o Large size (2.0 cm or greater)

o Positive margins on recent excision

o Poorly defined borders

o In the very young (<40 yr. age)

o Radiation-induced

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20

o In patients with proven difficulty with skin cancers or who are immunocompromised

o Basal cell nevus syndrome

o In an old scar (e.g., a Marjolin's ulcer)

o Associated with xeroderma pigmentosum

o Perineural invasion on biopsy or recent resection

o Deeply infiltrating lesion or difficulty estimating depth of lesion

Mohs micrographic surgery is considered not medically necessary for all other indications because its

effectiveness for indications other than those listed above has not been established.








denied.


Revised criteria for non-custom/custom-made gradient compression

garments/stockings

Highmark Blue Cross Blue Shield is revising the coverage criteria for non-custom/custom-made gradient

compression garments/stockings. Effective Oct. 27, 2014, the following guidelines will be added to the

existing selection criteria for non-custom/custom-made gradient compression garments/stockings.

Non-custom-made gradient compression garments/stockings

A qualified health care professional must measure the individuals effective area (i.e., physician,

physician assistant, certified registered nurse practioner, or nurse)

Replacement of non-custom-made gradient compression garments/stockings

A written, signed, and dated order must be received by the supplier before dispensing

replacement of non-custom-made gradient compression garment/stocking; and

PRN 8/2014

21

Custom-made gradient compression stockings/sleeve

A written, signed, and dated order must be received by the supplier before dispensing custom-

made gradient compression stockings/sleeve; and

A qualified health care professional must measure the individuals effective area (i.e., physician,

physician assistant, certified registered nurse practioner, or nurse)

Replacement custom-made gradient compression garments

A written, signed, and dated order must be received by the supplier before dispensing

replacement custom-made gradient compression stockings/sleeve.


Invitae genetic assay coverage defined

Effective Oct. 27, 2014 Highmark Blue Cross Blue Shield will consider invitae genetic assay

experimental/investigational.

While current literature reports invitae genetic assay is promising, there are not enough clinical trials and

peer reviewed literature to establish clinical efficacy.


Immune prophylaxis for Respiratory Syncytial Virus revised

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will revise the coverage for Immune

Prophylaxis for Respiratory Syncytial Virus (RSV) according to the American Academy of Pediatrics

2012 Redbook. Per the 2012 guidelines, the following criteria were updated:

Infants born at 32 to less than 35 weeks’ gestation (defined as 32 weeks, 0 days through 34 weeks, 6

days). Available data does not enable definition of a subgroup of infants at risk of prolonged

hospitalization and admission to the intensive care unit. Therefore, current recommendations are intended

to reduce the risk of RSV hospitalization during the period of greatest risk (the first 3 months of life)

among infants with consistently identified risk factors for hospitalization. Palivizumab prophylaxis should

be limited to infants in this group at greatest risk of hospitalization due to RSV, namely infants younger

than 3 months of age at the start of the RSV season or who are born during the RSV season and who are

likely to have an increased risk of exposure to RSV. Epidemiologic data suggest that RSV infection is

PRN 8/2014

22

more likely to occur and more likely to lead to hospitalization for infants in this gestational age group

when at least one of the following two risk factors is present:

Infant attends child care, defined as a home or facility where care is provided for any number of

infants or young toddlers in the child care facility; or

Infant has one or more older siblings younger than 5 years of age, or other children younger than

5 years of age who live permanently in the same household. (Multiple births younger than 1 year

of age do not qualify as this risk factor.)


Additional criteria added for denosumab (Prolia®, Xgeva®)

Effective Oct. 27, 2014, the criteria for Prolia® and Xgeva® will change to the following:

Coverage for injectable medications is determined according to individual or group customer benefits.

Denosumab (Prolia)

Denosumab (Prolia), is a RANK ligand (RANKL) inhibitor, may be considered medically necessary for

the following indications:

To increase bone mass in men at high risk for fracture (T score <-1.0 and multiple risk factors for

fracture; OR a previous osteoporotic fracture) who are receiving androgen deprivation therapy for

non-metastatic prostate cancer.

To increase bone mass in women at high risk for fracture (T score <-1.0 and multiple risk factors

for fracture; OR a previous osteoporotic fracture) who are receiving adjuvant aromatase therapy

for breast cancer.

To treat osteoporosis and to prevent fractures in men and postmenopausal women who have a

documented bone mineral density (BMD) T-score <-2.5 establishing the diagnosis of

osteoporosis; and

o The member has had an adequate trial and failure of at least one bisphosphonate. Trial

and failure will be defined as a decrease in BMD despite a trial and failure of

bisphosphonate therapy; or

o The member has a contraindication to at least one bisphosphonate or a significant reason

why a bisphosphonate may not be used (e.g. severe GERD). Contraindications to

bisphosphonate therapy include hypocalcemia, esophageal ulcerations, esophageal

stricture, Barrett's esophagitis, active ulcers and an inability to stand or sit upright for 30

minutes.

PRN 8/2014

23

To prevent fractures in men and postmenopausal women with a low bone mass (T-score between

-1 and -2.5) AND history of a previous osteoporotic fracture; and





why a bisphosphonate may not be used (e.g., severe GERD). Contraindications

to bisphosphonate therapy include hypocalcemia, esophageal ulcerations, esophageal


minutes.

To prevent fractures in men and postmenopausal women who are found to have a 10-year risk of

major osteoporotic fracture greater than or equal to 20% or a risk of hip fracture greater than or

equal to 3% using the FRAX calculator; and





why a bisphosphonate may not be used (e.g., severe GERD). Contraindications to



minutes.

Denosumab (Xgeva)

Denosumab (Xgeva), a RANK ligand (RANKL) inhibitor, may be considered medically necessary for

either of the following indications:

A. For the prevention of skeletal-related events in adults (greater than or equal to 18 years of age)

with bone metastases from ANY of the following solid tumor types:

Invasive breast cancer in patients with expected survival of ≥3 months and adequate renal

function

Castration-recurrent prostate cancer with documented creatinine clearance greater than 30

mL/min

Non-small cell lung cancer (NSCLC)

Kidney cancer

Thyroid cancer (follicular, Hürthle cell, medullary, or papillary carcinoma)

OR

PRN 8/2014

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B. For the treatment of localized or metastatic giant cell tumor of the bone (GCTB) that is

unresectable or where surgical resection is likely to result in severe morbidity when either of the

following criteria below are met:

Adults (greater than or equal to 18 years of age); or

Skeletally mature adolescents (defined by at least 1 mature long bone [for example;

closed epiphyseal growth plate of the humerus]).

Limitations of coverage

Denosumab is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be

corrected prior to initiating denosumab.

Patients receiving Prolia should not receive XGEVA (denosumab), as both Prolia and XGEVA

contain the same active ingredient, denosumab.

Warning: Women should be advised not to become pregnant when taking Xgeva. If this drug is

used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient

should be apprised of the potential hazard to the fetus.

Denosumab (Xgeva) is not approved for patients with multiple myeloma or other cancer of the

blood.

The use of denosumab (Prolia) for any other indication not listed above is considered

experimental/investigational, and therefore, not covered. A participating, preferred, or network provider

can bill the member for the denied service.

Denosumab (Xgeva) is considered experimental/investigational when all of the criteria specified above

are not met, or for the treatment of all other indications.

Denosumab (Xgeva) is considered experimental/investigational for the prevention of skeletal related

events in individuals with multiple myeloma.

A participating, preferred, or network provider can bill the member for the non-covered service.

Note: Dosage recommendations per the FDA label.

It is recommended that the member take calcium and vitamin D supplements on a daily basis to treat or

prevent hypocalcemia.

Note: Coverage for denosumab (Prolia, Xgeva)(J0897) is determined according to individual or group

customer benefits.

PRN 8/2014

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Additional criteria for single photon emission computed tomography

added to policy

Effective Oct. 27, 2014, the criteria for SPECT imaging will be as follows:

SPECT scans may be considered medically necessary for any of the following:

Bone (78320) and joint conditions—to differentiate between infectious, neoplastic, avascular or a

traumatic process

Brain tumors (78607)—to differentiate between lymphomas and infections such as toxoplasmosis

particularly in the immunosuppressed, or recurrent tumor vs. radiation changes, when PET is not

available

Liver (78205, 78206) hemangioma—using labeled red blood cells to further define lesions

identified by other imaging modalities

Localization (78807) of abscess/infection/inflammation in soft tissues or cases of fever of

unknown origin

Neuroendocrine tumors (78803)(e.g., adenomas, carcinoid, pheochromocytomas, neuroblastoma,

vasoactive intestinal peptide [VIP] secreting tumors, thyroid carcinoma, adrenal gland tumors)—

using a monoclonal antibody or meta-iodobenzyl-guanidine (MIBG).

Parathyroid imaging (78071)

Renal (78710)—Dimercaptosuccinic acid (DMSA) scan to assess the status of kidney for scarring

and function

SPECT imaging of the kidneys (78710) may be considered medically necessary in the diagnosis and

treatment of renal diseases, conditions, and disorders, including but not limited to the following (NOTE:

this is not an all-inclusive list):

Acute, chronic or recurrent kidney infections (e.g., pyelonephritis);

Evaluations of kidney tumors and trauma;

Pediatric patients with urinary tract infection;

Congenital anomalies of the kidneys;

Renal cortical damage or defects;

Renal infarction or renal masses;

Vesicoureteral reflux in children;

Assessing the integrity of renal parenchyma in cases of renal wasting diseases.

PRN 8/2014

26

For non-cardiovascular indications for any other reason than indicated above, SPECT scans are

considered experimental/investigational. Scientific evidence does not support the effectiveness for any

other indications. These include, but are not limited to:

Attention Deficit and Hyperactivity Disorder

Chronic fatigue syndrome

Colorectal carcinoma (e.g., used with the monoclonal antibody or IMMU-4 and CEA-Scan®)

Dopamine transporter (DaT) scan for all indications (A9584)

Malignancies other than those listed as medically necessary

Neuropsychiatric disorders without evidence of cerebrovascular disease

Pervasive development disorders (PDD)

Prostate carcinoma (e.g., used with the monoclonal antibody ProstaScint, with or without fusion

imaging with computed tomography or magnetic resonance imaging)

Scintimammography for breast cancer (S8080)

SPECT/SISCOM for the preoperative evaluation of individuals with intractable focal epilepsy to

identify and localize area(s) of epileptiform activity when other techniques designed to localize a

focus are indeterminate

A participating, preferred, or network provider can bill the member for the denied service.

SPECT scans are considered not medically necessary for the evaluation or management of

cerebrovascular accident (CVA, stroke), subarachnoid hemorrhage, or transient ischemic attack.

A Pennsylvania participating, preferred or network provider cannot bill the member for the denied service






denied.

Payment can be made for either a planar (standard) or SPECT study. However, when both are performed

on the same day by the same provider on the same anatomic area and reported separately, payment should

only be made for the SPECT study. The planar study is denied as not medically necessary. A

participating, preferred, or network provider cannot bill the member for the denied service. Payment for a

planar study is eligible only when a review of the information in the patient's clinical record establishes

the medical necessity for both studies. Modifier 59 may be reported with a non-E/M service, to identify it

PRN 8/2014

27

as distinct or independent from other non-E/M services performed on the same day. When modifier 59 is

reported, the patient’s records must support its use in accordance with CPT guidelines.

When a radiopharmaceutical (78803) diagnostic imaging agent is reported in conjunction with a covered

nuclear medicine study, payment is made for the agent under the appropriate code for the

radiopharmaceutical administered. The diagnostic imaging agent/contrast material used in conjunction

with an eligible imaging procedure is also eligible when administered by the health care professional in a

setting other than a hospital, or a skilled facility.

For guidelines on cerebrospinal fluid (CSF) flow SPECT imaging (78647), see Medical Policy G-21.

For guidelines on myocardial SPECT studies, see Medical Policy Bulletin R-5.

Please refer to Medical Policy R-6 for more information.

Coverage criteria revised for blepharoplasty

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will revise the clinical criteria of the surgical

procedure of blepharoplasty.

Blepharoplasty (15820-15823), brow lift, and blepharoptosis (67900-67906) are considered medically

necessary for ANY of the following conditions:

The upper eyelid margin within 2.5 mm (1/4 of the diameter of the visible iris) of the corneal

light reflex (MRD ≤ 2.5 mm), with patient in primary gaze;

The upper eyelid skin rests on the eyelashes;

The upper eyelid indicates the presence of dermatitis;

The upper eyelid position contributes to difficulty tolerating a prosthesis in an ophthalmic socket;

The brow position is below the superior orbital rim;

Entropian (eyelashes turning under)

AND

When all of the following criteria are met:

1. The impairment is documented by preoperative photographs, maintained in the patient's records,

including one view of the patient in primary position, one view looking up and one looking down

and should demonstrate the functional deficit;

PRN 8/2014

28

2. An automated visual field study was done except for upper eyelid dermatitis, ocular prosthesis

problem, and entropian and interpreted by the doctor who performed the study for the following

functional deficits:

Visual impairment due to dermatochalasis when the upper eyelid margin within 2.5 mm

(1/4 of the diameter of the visible iris) of the corneal light reflex (MRD ≤ 2.5 mm), with

patient in primary gaze; or

The brow position is below the superior orbital rim; and

3. A statement is submitted from the doctor who performed the visual field study with

documentation of taped and untaped automated visual field testing confirming that the visual

deficit shown by the study is caused by the eyelid's condition and that the proposed surgery is

being performed in an attempt to correct the visual deficit.

Blepharoplasty, lower lid (15820 and 15821) may be considered medically necessary for reconstructive

repair where there is functional visual impairment due to the ONE of the following conditions:

Ectropion, entropion, or epiblepharon repair for corneal and/or conjunctival injury;

Disease due to ectropion, entropion, trichiasis, or epiblepharon;

Poor eyelid tone (with or without entropion) that causes lid retraction and/or exposure;

Keratoconjunctivitis often resulting in epiphora;

Lower eyelid edema due to a metabolic or inflammatory disorder when the edema is causing a

persistent visual impairment (e.g., secondary to systemic corticosteroid therapy, myxedema,

Grave's disease, nephrotic syndrome) and is unresponsive to conservative medical management.

AND

1. The impairment is documented by preoperative photographs, maintained in the patient's records,

including one view of the patient in primary position, one view looking up and one looking down

and should demonstrate the functional deficit;

2. An automated visual field study completed. A statement is submitted from the doctor who

performed the visual field study with documentation of taped and untaped automated visual field

testing confirming that the visual deficit shown by the study is caused by the eyelid's condition

and that the proposed surgery is being performed in an attempt to correct the visual deficit.

3. Functional impairment including both of the following:

o Documented uncontrolled tearing or irritation; and

o Conservative treatments tried and failed.


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Clinical criteria established for docetaxel (Taxotere®)

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will create a new policy with clinical criteria

for docetaxel (Taxotere®). The use of docetaxel may be considered medically necessary when used in the

treatment of the following condition(s):

Bladder Cancer

Primary treatment as a single agent or in combination therapy for patients with clinical node

negative stage T2, T3, or T4a disease with extensive comorbid disease or poor performance

status.

May be considered for recurrent or metastatic disease as:

o a first-line alternative therapy, single agent, or in combination therapy for patients who

cannot receive cisplatin due to impaired renal function or other comorbidities, or

o used as a second-line therapy, single agent, if not used as a first line therapy.

As radiosensitizing chemotherapy given concurrently with radiation for palliation of metastases

or for pelvic recurrence after cystectomy.

Bladder Cancer – Primary Carcinoma of the Urethra

Used as a single-agent therapy for:

o primary treatment for clinical stage T3-4, cN1-2 disease or cN1-2 palpable inguinal

lymph nodes, or

o for recurrent or metastatic disease.




o as a second-line therapy, single agent, if not used as a first line therapy.

Bladder Cancer – Upper GU Tract Tumors





Bladder Cancer – Urothelial Carcinoma of the Prostate




PRN 8/2014

30


Bone Cancer – Ewing’s Sarcoma Family of Tumors

Used with growth factor support in combination with gemcitabine with or without vincristine or:

o with or without radiation therapy for relapse, or

o for progressive disease following primary treatment, or

o as second-line therapy for metastatic disease.

Bone Cancer – Osteosarcoma

As a second-line therapy in combination with gemcitabine with growth factor support.

Breast Cancer – Invasive

As a preoperative systemic therapy for patients with stage IIA, IIB, or T3, N1, M0 disease who

desire breast preservation and fulfill criteria for breast-conserving surgery except for tumor size

or for locally advanced disease (stage IIIA, IIIB, or IIIC):

o in combination with cyclophosphamide (preferred), or

o following AC (doxorubicin and cyclophosphamide) regimen, or

o following FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen, or

o in TAC (docetaxel, doxorubicin, and cyclophosphamide) regimen, or

o in TCH (docetaxel, carboplatin, and trastuzumab) (preferred regimen) or in combination

with trastuzumab following AC regimen for human epidermal growth factor receptor 2-

positive tumors.

In TCH regimen with pertuzumab for HER2-positive, ≥T2 or ≥N1 early stage breast cancer.

In combination with trastuzumab and pertuzumab following AC regimen or prior to or following

FEC/CEF regimen for HER2-positive, ≥T2 or ≥N1 early stage breast cancer.

As an adjuvant systemic therapy for stage I, IIA, IIB, or T3, N1, M0 disease or for locally

advanced disease (stage IIIA, IIIB, or IIIC):


o following AC regimen, or

o following FEC/CEF regimen, or

o in TAC regimen, or

o in TCH (preferred regimen) or in combination with trastuzumab following AC regimen

for human epidermal growth factor receptor 2 (HER2)-positive tumors, or

o in TCH regimen in combination with pertuzumab (preferred regimen) for HER2-positive,

≥T2 or ≥N1 early stage breast cancer if a pertuzumab-containing regimen was not used as

neoadjuvant therapy, or

PRN 8/2014

31

o in combination with trastuzumab and pertuzumab following AC regimen or prior to or

following FEC/CEF regimen for HER2-positive, ≥T2 or ≥N1 early stage breast cancer if

a pertuzumab-containing regimen was not used as neoadjuvant therapy.

As a single agent or in combination with capecitabine for recurrent or metastatic disease that is:

o hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative,

with visceral crisis, or

o HER2-negative and either hormone receptor-negative or hormone receptor-positive and

endocrine therapy refractory, or

o progressive with no clinical benefit after three consecutive endocrine therapy regimens or

with symptomatic visceral disease.

Used in combination with trastuzumab for recurrent or metastatic disease as first-line therapy for

human epidermal growth factor receptor 2 (HER2)-positive disease or as therapy for trastuzumab-

exposed HER2-positive disease that is:

o hormone receptor-positive with visceral crisis, or



Used for recurrent or metastatic human epidermal growth factor receptor 2-positive disease that is

either hormone receptor-negative or hormone receptor-positive and endocrine therapy refractory

or with symptomatic visceral disease:

o as a preferred first-line therapy in combination with pertuzumab and trastuzumab, or

o may be considered in combination with pertuzumab and trastuzumab for one line of

therapy beyond first-line therapy for patients previously treated with chemotherapy and

trastuzumab in the absence of pertuzumab.

Cervical Cancer

As a second-line therapy, single agent for:

o local/regional recurrence, or

o distant metastases.

Esophageal and Esophagogastric Junction Cancers

Used in medically fit patients in combination with cisplatin as a:

o definitive chemoradiation for patients who decline surgery for adenocarcinoma and

recommended for cervical esophagus squamous cell carcinoma for T1b, N+ or T2-4a,

N0-N+, or

o as a definitive chemoradiation for T4b.

As a definitive concurrent chemoradiation for locoregional disease in combination with cisplatin:

PRN 8/2014

32

o for medically unfit patients with T1b, N0 tumors with poor prognostic features, or

o as primary treatment for T1b, N+, T2-T4a, or unresectable T4b disease for patients who

are unfit for or do not elect surgery.

As concurrent chemoradiation in combination with cisplatin for locoregional recurrence for

patients who have had surgery but no prior chemoradiation.

As palliative therapy for patients with Karnofsky performance score ≥60% or ECOG performance

score ≤2 as a single agent (preferred for second line), in combination with cisplatin (first line) or

irinotecan, or as a component of preferred first-line DCF (docetaxel, cisplatin, and fluorouracil)

regimen or its modifications (docetaxel, cisplatin, and fluorouracil; docetaxel, oxaliplatin, and

fluorouracil; or docetaxel, carboplatin, and fluorouracil) for:

o T4b squamous cell carcinoma with invasion of the trachea, great vessels, heart, or

o macroscopic residual disease, or

o primary treatment for T1b, N+, T2-T4a, or unresectable T4b disease for patients who are

unfit for or do not elect surgery, or

o persistent, unresectable locally advanced, locally recurrent, or metastatic disease.

Gastric Cancer

As a primary treatment with docetaxel-based chemoradiation for:

o unresectable locoregional disease in medically fit patients, or

o locoregional disease in medically unfit patients.

As a palliative therapy for patients with Karnofsky performance score ≥60% or ECOG

performance score ≤2 as a single agent (preferred for second line), in combination with cisplatin

(first line) or irinotecan, or as a component of preferred first-line DCF regimen or its

modifications (docetaxel, cisplatin, and fluorouracil; docetaxel, oxaliplatin, and fluorouracil; or

docetaxel, carboplatin, and fluorouracil) for:

o locoregional disease in medically unfit patients, or


o medically inoperable or unresectable residual disease following primary treatment, or

o unresectable locally advanced, locally recurrent, or metastatic disease.

Head and Neck Cancers – Advanced, Recurrent, Persistent

For non-nasopharyngeal cancer in combination with cisplatin and fluorouracil in patients with

performance status 0-1 for:

o newly diagnosed T4b, any N, unresectable nodal disease with no metastases, or patients

unfit for surgery, or

PRN 8/2014

33

o unresectable locoregional recurrence in patients who have not received prior radiation

therapy.

Therapy as a:

o single agent for patients with performance status (PS) 3 with newly diagnosed T4b, any

N, unresectable nodal disease with no metastases, or with unresectable locoregional

recurrence and no prior radiation therapy (RT), or for patients who are unfit for surgery,

or

o single agent in PS 0-2 patients or in combination (PS 0-1) with cisplatin with (non-

nasopharyngeal cancer) or without cetuximab or with carboplatin for unresectable

locoregional recurrence or second primary in patients who have received prior RT or for

distant metastases.

Head and Neck Cancers – Cancer of the Glottic Larynx

As induction chemotherapy in combination with cisplatin and fluorouracil for:

o T3, N0-3 disease requiring (amenable to) total laryngectomy, or

o selected T4a patients who decline surgery.


o T1, N+, or

o T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy, or

o T4a, any N disease.

Head and Neck Cancers – Cancer of the Hypopharynx


o T1, N+, or



Head and Neck Cancers – Cancer of the Nasopharynx

As induction chemotherapy in combination with cisplatin with or without fluorouracil for:

o T1, N1-3 disease, or

o T2-4, any N disease.

Primary therapy in combination with cisplatin or carboplatin for any T, any N, M1 disease.

Head and Neck Cancers – Cancer of the Oropharynx


o T3-4a, N0-1 disease, or

o any T, N2-3 disease.

PRN 8/2014

34

Head and Neck Cancers – Cancer of the Supraglottic Larynx


o T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy, or

o T1-2, N+ and selected T3, N1 disease amenable to larynx-preserving (conservation)

surgery, or

o T4a, N0-3 patients who decline surgery.

Head and Neck Cancer – Occult Primary

Initial definitive treatment in combination with cisplatin and fluorouracil.

Non-Small Cell Lung Cancer (NSCLC)

When used in combination with cisplatin as:

o neoadjuvant chemotherapy for T3 invasion or resectable T4 extension, N0-1 disease in

the chest wall, proximal airway, or mediastinum, or

o induction chemotherapy with or without radiation for T1-2 or T3 (≥7 cm), N2, M0, or

o may be used as induction chemotherapy for T1-3, N0-1 (including T3 with multiple

nodules in the same lobe) as an alternative for patients likely to receive adjuvant

chemotherapy.

As an adjuvant chemotherapy in combination with cisplatin:

o following definitive radiation therapy in medically inoperable high-risk stage IB

(peripheral T2a, N0), stage I (central T1ab- 2a, N0), stage II (T1ab- 2ab, N1; T2b, N0), or

stage IIB (T3, N0) with negative mediastinal nodes and N0 disease, or

o for high-risk, margin-negative stage IB (T2a, N0) and IIA (T2b, N0), or

o for margin-positive stage IB (T2a, N0) and IIA (T2b, N0), or

o for margin-positive stage IIA (T2b, N0) following radiation, or

o for stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1), or

o for margin-negative stage IIIA (T1-3, N2; T3, N1), or

o for resectable or possibly resectable superior sulcus tumors (T3 invasion, T4 extension,

N0-1), or

o for T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall, proximal

airway, or mediastinum if not given as initial treatment, or

o for margin-negative or margin positive, R1 T1-3 (including T3 with multiple nodules in

the same lobe), N2, or

o for T1-2, T3 (≥7 cm), N2, M0 with no apparent progression or local progression, or

o separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4),

N0-1, or

PRN 8/2014

35

o for margin-negative or margin-positive, R1 separate pulmonary nodule(s) in the same

lobe (T3) or ipsilateral nonprimary lobe (T4), N2.

Therapy for recurrence or metastasis:

o as a first line therapy in combination with cisplatin, carboplatin, or gemcitabine in

performance status (PS) 0-2 or elderly patients, or

o as a first line therapy, single agent, for PS 2 or elderly patients, or

o as a second line therapy, single agent, for progression in patients with negative or

unknown EGFR mutation status if not already given, or

o as a third line therapy, single agent, for progressive disease in patients with PS 0-2 if not

already given.

As a first-line therapy in cisplatin- or carboplatin-based regimens in combination with

bevacizumab for recurrence or metastasis for patients with performance status 0-1, tumors of

nonsquamous cell histology, and no history of recent hemoptysis.

As a single-agent switch maintenance for recurrence or metastasis of squamous cell carcinoma

for patients with performance status 0-2 who achieve tumor response or stable disease following

first-line chemotherapy.

Occult Primary

When used as chemoradiation in combination with carboplatin or gemcitabine in symptomatic

patients with performance status (PS) 1-2 or asymptomatic patients with PS 0 and aggressive

disease for localized disease with axillary or inguinal nodal involvement.

When used in combination with carboplatin or gemcitabine in symptomatic patients with

performance status (PS) 1-2 or asymptomatic patients with PS 0 and aggressive disease for:

o lung nodules or breast marker-negative pleural effusion, or

o resectable liver disease, or

o peritoneal mass with nonovarian histology or retroperitoneal mass of nongerm cell

histology in selected patients, or

o unresectable liver disease or disseminated metastases.

When used in combination with cisplatin or carboplatin or with cisplatin and fluorouracil in

symptomatic patients with performance status (PS) 1-2 or asymptomatic patients with PS 0 and

aggressive disease for:

o chemoradiation in patients with axillary or inguinal nodal involvement, or

o chemotherapy in patients with multiple lung nodules, pleural effusion, or disseminated

metastases.

PRN 8/2014

36

Ovarian Cancer – Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer

As a neoadjuvant chemotherapy in combination with carboplatin for bulky stage III-IV disease in

poor surgical candidates.

Used in combination with carboplatin as:

o a primary treatment for incompletely staged (stage IA-IB, grade 2-3 or clear cell and

stage IC) patients with no suspected residual disease, or

o a primary adjuvant treatment for pathologic stage IA-IB (grades 2-3 or clear cell) and for

stage IC (all grades).


o a primary treatment for incompletely staged (stage II-IV) patients with suspected

unresectable residual disease, or

o a primary adjuvant treatment for pathologic stage II-IV disease following completion

surgery in selected patients.

In combination with carboplatin for clinical relapse or recurrence as evidenced by rising CA-125

levels in patients who have received no prior chemotherapy.

As a preferred single-agent therapy, if platinum-resistant, for persistent disease or recurrence.

As a preferred therapy, if platinum-sensitive, in combination with carboplatin for persistent

disease or recurrence.

Ovarian Cancer – Malignant Germ Cell Tumors

Used as a single agent or in combination with carboplatin for recurrent or residual disease.

Ovarian Cancer – Malignant Sex Cord-Stromal Tumors

As a single agent for clinical relapse in patients with stage II-IV disease.

Pancreatic Adenocarcinoma

Used for patients with locally advanced unresectable or metastatic disease and good performance

status as a component of GTX (gemcitabine, docetaxel, and capecitabine) regimen.

Penile Cancer

As a single-agent therapy for second-line treatment of metastatic disease.

Prostate Cancer

Used in combination with prednisone for:

o castration-recurrent metastatic disease, or

o treatment of distant metastases with small cell features.

PRN 8/2014

37

Small Cell Lung Cancer (SCLC)

As subsequent chemotherapy for patients with performance status 0-2 as single agent for:

o relapse within 6 months following complete or partial response or stable disease with

initial treatment, or

o primary progressive disease.

Soft Tissue Sarcoma – Angiosarcoma

Used for angiosarcoma:

o as a single agent, or

o in combination with gemcitabine.

Soft Tissue Sarcoma – Retroperitoneal/Intra-abdominal

Used in combination with gemcitabine for:

o preoperative chemotherapy for resectable disease, or

o primary therapy for attempted downstaging of unresectable, recurrent, or metastatic

disease, or

o palliative therapy for unresectable or progressive disease.

Soft Tissue Sarcoma – Rhabdomyosarcoma

As a therapy in combination with gemcitabine for pleomorphic rhabdomyosarcoma.

Soft Tissue Sarcoma of the Extremity/Superficial Trunk


o preoperative chemotherapy or chemoradiation for resectable stage IIB-III tumors

(primary tumors or local recurrence) with acceptable functional outcomes, or

o primary treatment as chemotherapy or chemoradiation for stage II-III resectable disease

with adverse functional outcomes or unresectable disease (primary tumors or local

recurrence), or

o adjuvant chemotherapy for resectable stage IIB-III disease (primary tumors or local

recurrence) with acceptable functional outcomes or for stage II-III resectable disease with

adverse functional outcomes, or

o treatment before or after metastasectomy with or without radiation therapy for single-

organ confined, limited tumor bulk synchronous stage IV or recurrent disease that is

amenable to local therapy or for recurrent isolated regional disease or isolated regional

lymph nodes, or

o chemotherapy with or without radiation following regional node dissection, or

PRN 8/2014

38

o palliative chemotherapy for synchronous stage IV or recurrent disease with disseminated

metastases.

Uterine Neoplasms – Endometrial Carcinoma

As a primary treatment (in patients in whom paclitaxel is contraindicated), single agent, or in

combination with carboplatin:

o with sequential radiation therapy (RT) and brachytherapy with or without surgery for

extrauterine pelvic disease, or

o following palliative hysterectomy with bilateral salpingo-oophorectomy with or without

RT and/or hormonal therapy for extra-abdominal or liver disease.

For surgically staged patients as a single agent or in combination with carboplatin as adjuvant

treatment (in patients in whom paclitaxel is contraindicated):

o with sequential pelvic radiation therapy (RT) and/or vaginal brachytherapy in patients

with stage IB disease with histologic grade 3 tumors and adverse risk factors, or

o with sequential pelvic RT and vaginal brachytherapy in patients with stage II disease with

histologic grade 3 tumors, or

o with or without sequential tumor-directed RT for stage IIIA, IIIB, and IIIC disease, or

o with or without sequential RT for stage IV disease.

Single agent or in combination with carboplatin as adjuvant treatment with sequential RT and

vaginal brachytherapy with or without para-aortic RT for incompletely surgically staged patients

with histologic grade 3 tumors.

As a single agent or in combination with carboplatin (in patients in whom paclitaxel is

contraindicated):

o for disseminated metastases that have progressed on hormonal therapy, or

o with or without sequential palliative radiation therapy (RT) for symptomatic, grade 2-3,

or large volume metastases, or

o with sequential tumor-directed RT with or without brachytherapy for local recurrence in

patients with disease confined to the vagina or in pelvic, para-aortic, or common iliac

lymph nodes, or

o with or without sequential tumor-directed RT for microscopic upper abdominal or

peritoneal recurrences, or

o for local/regional recurrence in patients who have received prior external beam RT to site

of recurrence.

As an adjuvant therapy (in patients in whom paclitaxel is contraindicated), single agent, or in

combination with carboplatin and with or without:

o vaginal brachytherapy for stage 1A disease with no myometrial invasion, or

PRN 8/2014

39

o sequential tumor-directed radiation therapy for stage 1A disease with myometrial

invasion or stage IB-IV disease.

Uterine Neoplasm – Uterine Sarcoma

Used in combination with gemcitabine (preferred for leiomyosarcoma):

o for medically inoperable disease limited to the uterus, or

o following total hysterectomy with or without bilateral salpingo-oophorectomy (TH±BSO)

for stage I-III disease, or

o following TH±BSO for stage IV disease, or

o for local recurrence confined to the vagina, or

o for extrapelvic recurrence with no prior radiation therapy, or

o for isolated metastases, postoperative chemotherapy for resectable isolated metastases, or

o for disseminated metastases.









denied.


Clinical criteria established for pemetrexed (Alimta®)


for pemetrexed (Alimta®). The use of pemetrexed may be considered medically necessary when used in

the treatment of the following condition(s):

Bladder Cancer

May be considered as a second-line therapy and a single agent for metastatic disease.

PRN 8/2014

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Bladder Cancer – Primary Carcinoma of the Urethra:






Central Nervous System Cancers – Primary CNS Lymphoma

As a single-agent for treatment of progressive or recurrent disease in patients who have received

prior methotrexate-based regimen without radiation therapy (RT):

o after prolonged response to prior regimen, or

o in combination with RT after short or no response to prior regimen.

Considered systemic treatment as a single agent for progressive or recurrent disease in patients

with prior whole brain radiation therapy.

Malignant Pleural Mesothelioma

As an induction therapy in combination with cisplatin for medically operable clinical stage I-II

disease.

Used as a single agent or in combination with cisplatin or carboplatin for:

o treatment of unresectable or medically inoperable clinical stage I-II disease and tumors of

epithelial or mixed histology, or

o treatment of resected clinical stage I-II disease in patients not treated with induction

chemotherapy, or

o treatment of clinical stage IV disease or tumors of sarcomatoid histology.

As a second-line treatment and a single agent if:

o not administered first line, or

o administered first line as rechallenge and had good sustained response at the time initial

chemotherapy was interrupted.


As a preoperative concurrent chemoradiation in combination with cisplatin or carboplatin for:

o resectable or possibly resectable superior sulcus tumors (T3 invasion, T4 extension, N0-

1), or

o T3 invasion or resectable T4 extension, N0-1 disease in the chest wall, proximal airway,

or mediastinum.

PRN 8/2014

41

Can be used in combination with cisplatin as:

o a neoadjuvant chemotherapy for T3 invasion or resectable T4 extension, N0-1 disease in


o induction chemotherapy with or without radiation for T1-2, T3 (≥7cm), N2, M0, or


nodules in the same lobe) and as an alternative for patients likely to receive adjuvant

chemotherapy.

Used as the initial treatment as definitive concurrent chemoradiation in combination with

carboplatin or cisplatin for:

o medically inoperable stage IB (peripheral T2a, N0), stage I (central T1ab-2a, N0), stage

II (T1ab-2ab, N1 or T2b, N0), or stage IIB (T3, N0) with negative mediastinal nodes and

N1 disease, or

o unresectable superior sulcus tumors (T4 extension, N0-1), or

o unresectable stage IIIA (T4, N0-1), or

o T1-2 or T3 (≥7 cm), N2, M0, or

o T3 invasion, N2, M0, or

o stage IIIB (T1-3, N3 positive, M0), or

o contralateral or ipsilateral mediastinal node-positive stage IIIB (T4 extension, N2-3.

As adjuvant chemotherapy in combination with cisplatin:

o consider following definitive radiation therapy in medically inoperable high-risk stage IB

(peripheral T2a, N0), stage I (central T1ab-2a, N0), stage II (T1ab- 2ab, N1; T2b, N0), or








N0-1), or



o for margin-negative or margin-positive, R1 T1-3 (including T3 with multiple nodules in



PRN 8/2014

42

o for separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe

(T4), N0-1, or



As adjuvant concurrent chemoradiation in combination with cisplatin or carboplatin for tumors of

nonsquamous cell histology for:

o margin-positive stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1), or

o margin-positive stage IIIA (T1-3, N2; T3, N1), or

o margin-positive T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall,

proximal airway, or mediastinum if not given as initial treatment, or

o margin-positive T1-3 (including T3 with multiple nodules in the same lobe), N2, or

o margin-positive separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral

nonprimary lobe (T4), N2.

Concurrent chemoradiation in combination with carboplatin or cisplatin if radiation not

previously given for locoregional recurrence in the mediastinal lymph nodes or for superior vena

cava obstruction.

As first-line therapy for recurrence or metastasis for tumors of nonsquamous cell histology:

o in combination with cisplatin or carboplatin in patients with performance status (PS) 0-2

or elderly patients, or

o in cisplatin- or carboplatin-based regimens in combination with bevacizumab in patients

with PS 0-1, tumors of nonsquamous cell histology, and no history of recent hemoptysis,

or

o as a single agent in PS 2 or elderly patients.

Therapy for recurrence or metastasis in patients with performance status 0-2 with tumors of

nonsquamous cell histology who achieve tumor response or stable disease following first-line

chemotherapy as:

o a single agent for continuation maintenance therapy if given first line with chemotherapy

or in combination with bevacizumab if bevacizumab previously used with a first-line

pemetrexed/platinum chemotherapy regimen, or

o a single agent for switch maintenance.

As a single agent if not already given for progressive disease in patients with performance status

0-2 with tumors of nonsquamous cell histology or as a:

o second-line therapy in patients with negative or unknown EGFR mutation status, or

o third-line therapy if not already given.

PRN 8/2014

43


As a single agent therapy for persistent disease or recurrence.

Thymoma and Thymic Carcinomas

As a second line therapy single agent following radiation therapy for locally advanced

unresectable disease.









denied.


Clinical criteria established paclitaxel (Taxol®)


for paclitaxel (Taxol®) will become effective. The use of paclitaxel may be considered medically

necessary when used in the treatment of the following condition(s):

Bladder Cancer

Primary treatment in combination with cisplatin and radiation therapy for clinical node-negative

stage T2, T3, and T4a disease for bladder preservation; or

Primary treatment as a single agent or in combination therapy for patients with clinical node-


status; or

Radiosensitizing chemotherapy given concurrently with radiation for palliation of metastases or

for pelvic recurrence after cystectomy; or

May be considered for recurrent or metastatic disease in:

PRN 8/2014

44

o first-line alternative therapy as a single agent or in combination therapy in patients who

cannot receive cisplatin due to impaired renal function or other comorbidities; or

o second-line therapy as a single agent if not used first line.


Used in combination with cisplatin and radiation therapy for:

o primary treatment for clinical stage T2 disease of the female urethra; or

o primary treatment for clinical stage T3-4 disease or palpable inguinal lymph nodes; or

o adjuvant treatment for clinical stage T2 disease with positive margins in the pendulous

urethra.

Single-agent therapy:

o as primary treatment for clinical stage T3-4, cN1-2 disease or cN1-2 palpable inguinal

lymph nodes; or


May be considered for recurrent or metastatic disease for:















Preoperative systemic therapy for patients with stage IIA, IIB, or T3, N1, M0 disease who desire

breast preservation and fulfill criteria for breast-conserving surgery except for tumor size or for

locally advanced disease (stage IIIA, IIIB, or IIIC) for:

o following dose-dense AC (doxorubicin and cyclophosphamide) as a component of a

weekly or dose-dense regimen (preferred); or

PRN 8/2014

45

o following FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen; or

o following FAC (fluorouracil/doxorubicin/cyclophosphamide) regimen; or

o administered weekly following AC regimen; or

o in combination with trastuzumab following AC regimen (preferred regimen) for human

epidermal growth factor receptor 2 (HER2)-positive tumors; or

o in combination with trastuzumab and pertuzumab following AC regimen (preferred

regimen) or prior to or following FEC/CEF regimen for HER2-positive, ≥T2 or ≥N1

early stage breast cancer.

Adjuvant systemic therapy for stage I, IIA, IIB, or T3, N1, M0 disease or for locally advanced

disease (stage IIIA, IIIB, or IIIC) for:

o following dose dense AC as a component of a weekly or dose-dense regimen (preferred);

or

o following FEC/CEF regimen; or

o following FAC regimen; or


o in combination with trastuzumab following AC regimen as preferred regimen for human


o in combination with trastuzumab and pertuzumab following AC regimen (as preferred


early stage breast cancer if a pertuzumab-containing regimen was not used as

neoadjuvant therapy.

May be considered in combination with trastuzumab for low-risk stage I, human epidermal

growth factor receptor 2-positive disease particularly for patients not eligible for other standard

adjuvant regimens due to comorbidities; or

Preferred single agent or in combination with gemcitabine or bevacizumab for recurrent or

metastatic disease for:

o hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative

with visceral crisis; or


endocrine therapy refractory; or



Used in combination with trastuzumab with or without carboplatin for recurrent or metastatic

disease as first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive

disease or as therapy for trastuzumab-exposed HER2-positive disease for:

PRN 8/2014

46

o hormone receptor-positive with visceral crisis; or





or with symptomatic visceral disease for:

o as preferred first-line therapy in combination with pertuzumab and trastuzumab; or


therapy beyond first-line therapy in patients previously treated with chemotherapy and


Breast Cancer – during pregnancy

Weekly paclitaxel can be used in pregnant women with confirmed breast cancer and no distant

metastases if clinically indicated by disease for:

o neoadjuvant chemotherapy in the second and early third trimesters; or

o adjuvant chemotherapy in the second and third trimesters if not used in the neoadjuvant

setting.

Cervical Cancer

First-line therapy as a single agent, in combination with carboplatin, or with cisplatin with or

without bevacizumab for:

o local/regional recurrence; or



Used in medically fit patients in combination with carboplatin as a preferred regimen, or with

cisplatin (definitive only), fluorouracil, or capecitabine for:

o preoperative chemoradiation for adenocarcinoma and for noncervical esophagus

squamous cell carcinoma for T1b, N+ or T2-4a, N0-N+; or

o definitive chemoradiation for patients who decline surgery and recommended for cervical

esophagus squamous cell carcinoma for T1b, N+ or T2-4a, N0-N+; or

o definitive chemoradiation for T4b.

Definitive concurrent chemoradiation in combination with carboplatin as a preferred regimen, or

with cisplatin, fluorouracil, or capecitabine for:

o for medically unfit patients with T1b, N0 tumors with poor prognostic features; or

PRN 8/2014

47

o as primary treatment for T1b, N+, T2-T4a, N0-N+, or unresectable T4b disease for

patients who are unfit for or do not elect surgery.

Concurrent chemoradiation in combination with carboplatin as a preferred regimen, or with

cisplatin, fluorouracil, or capecitabine for locoregional recurrence in patients who have had

surgery but no prior chemoradiation for:

o palliative therapy for patients with Karnofsky performance score ≥60% or ECOG

performance score ≤2 as a single agent (preferred for second-line therapy) or in

combination with cisplatin (first line), or carboplatin (first line); or

o T4b squamous cell carcinoma with invasion of the trachea, great vessels, and heart; or

o macroscopic residual disease; or


unfit for or do not elect surgery; or


Palliative therapy for patients with Karnofsky performance score ≥60% or ECOG performance

score ≤2 in combination with ramucirumab as preferred second-line therapy for esophagogastric

junction adenocarcinoma for:


o primary treatment for T1b, N+, T2-4a, or unresectable T4b disease for patients who are



Gastric Cancer

Preoperative chemoradiation in combination with carboplatin as a preferred regimen or with

capecitabine or fluorouracil for resectable locoregional disease (T2 or higher by clinical staging,

any N) in medically fit patients; or

Primary treatment as paclitaxel-based chemoradiation for:

o unresectable locoregional disease in medically fit patients; or



score ≤2 as a single agent (preferred for second-line therapy) or in combination with cisplatin

(first line), carboplatin (first line), or ramucirumab (preferred second-line therapy) for:

o locoregional disease in medically unfit patients; or


o medically inoperable or unresectable residual disease following primary treatment; or

o unresectable locally advanced, locally recurrent or metastatic disease.

PRN 8/2014

48


Primary concurrent chemoradiation for non-nasopharyngeal cancer in combination with cisplatin

or carboplatin for:

o patients with performance status (PS) 0-2 who have newly diagnosed T4b, any N,

unresectable nodal disease with no metastases, or who are unfit for surgery; or

o locoregional recurrence in PS 0-2 patients who have not received prior radiation therapy.

Induction chemotherapy for non-nasopharyngeal cancer in combination with cisplatin and

fluorouracil in patients with performance status 0-1 for:


unfit for surgery; or


therapy.

Therapy for:



recurrence and no prior radiation therapy (RT), or for patients who are unfit for surgery;

or

o single agent in PS 0-2 patients or in combination (PS 0-1) with cisplatin and cetuximab

(non-nasopharyngeal cancer) or with cisplatin or carboplatin for unresectable


distant metastases.


Primary concurrent chemoradiation in combination with cisplatin or carboplatin for:

o for T3, N0-3 disease requiring (amenable to) total laryngectomy; or

o consider for selected T4a patients who decline surgery.

Induction chemotherapy in combination with cisplatin and fluorouracil for:

o T3, N0-3 disease requiring (amenable to) total laryngectomy; or




o T1, N+; or

o T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy; or



PRN 8/2014

49

o T1, N+; or



Head and Neck Cancers – Cancer of the Lip

Primary concurrent chemoradiation in combination with cisplatin or carboplatin for patients with

T3-4a, N0 or for patients with any T, N1-3 disease who are candidates for but do not receive

surgery.


Induction chemotherapy in combination with cisplatin and epirubicin for:

o T1, N1-3 disease; or





o T2, N1 disease; or

o T3-4a, N0-1 disease; or







o T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy; or


surgery; or

o consider for T4a, N0-3 patients who decline surgery.




surgery; or


PRN 8/2014

50

Head and Neck Cancers – Ethmoid Sinus Tumors


o newly diagnosed T3-4b disease; or

o patients who decline surgery; or

o cancer diagnosed after incomplete excision with gross residual disease.

Head and Neck Cancers – Maxillary Sinus Tumors

Consider preoperative concurrent chemoradiation in combination with cisplatin or carboplatin in

select patients with T3-4a, N0; or

Primary concurrent chemoradiation in combination with cisplatin or carboplatin for T4b, any N

Head and Neck Cancers – Occult Primary

Initial definitive treatment for:

o concurrent chemoradiation for ≥N2 disease in combination with cisplatin or carboplatin;

or

o induction chemotherapy in combination with cisplatin and fluorouracil.

Kidney Cancer

May be used in combination with carboplatin in patients with collecting duct or medullary

subtypes

Melanoma; or

Single agent or in combination with carboplatin for:

o unresectable stage III in-transit metastases; or

o local/satellite and/or in-transit unresectable recurrence; or

o incompletely resected or unresectable nodal recurrence; or

o recurrent or metastatic disease in patients with good performance status.


Preoperative concurrent chemoradiation in combination with carboplatin for patients with

comorbidities or who are unable to tolerate cisplatin followed by chemotherapy with 2 cycles of

paclitaxel and carboplatin for T3 invasion or resectable T4 extension, N0-1 disease in the chest

wall, proximal airway, or mediastinum; or

Used in combination with carboplatin for patients with comorbidities or who are unable to

tolerate cisplatin for:


the chest wall, proximal airway, or mediastinum; or

o induction chemotherapy with or without radiation for T1-2 or T3 (≥7 cm), N2, M0; or

PRN 8/2014

51



chemotherapy.

Initial treatment as definitive concurrent chemoradiation in combination with carboplatin for

patients with comorbidities or who are unable to tolerate cisplatin followed by chemotherapy with

2 cycles of paclitaxel and carboplatin for:



N1 disease; or

o unresectable superior sulcus tumors (T4 extension, N0-1); or

o unresectable stage IIIA (T4, N0-1); or

o T1-2, T3 (≥7cm), N2, M0; or

o T3 invasion, N2, M0; or

o stage IIIB (T1-3, N3 positive, M0); or

o contralateral or ipsilateral mediastinal node-positive stage IIIB (T4 extension, N2-3).

Adjuvant chemotherapy in combination with carboplatin for patients with comorbidities or who

are unable to tolerate cisplatin for:



stage IIB (T3, N0) with negative mediastinal nodes and N0 disease; or

o for high-risk, margin-negative stage IB (T2a, N0) and IIA (T2b, N0); or

o for margin-positive stage IB (T2a, N0) and IIA (T2b, N0); or

o for margin-positive stage IIA (T2b, N0) following radiation; or

o for stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1);or

o for margin-negative stage IIIA (T1-3, N2; T3, N1); or


N0-1)


airway, or mediastinum if not given as initial treatment; or


the same lobe), N2; or

o for T1-2, T3 (≥7 cm), N2, M0 with no apparent progression or local progression; or


(T4), N0-1; or

PRN 8/2014

52



Adjuvant concurrent chemoradiation in combination with carboplatin followed by chemotherapy

with 2 cycles of paclitaxel and carboplatin for:

o margin-positive stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1); or

o margin-positive stage IIIA (T1-3, N2; T3, N1); or


proximal airway, or mediastinum if not given as initial treatment; or

o margin-positive T1-3 (including T3 with multiple nodules in the same lobe), N2; or



Sequential chemoradiation in combination with carboplatin for:

o initial definitive therapy for medically inoperable stage IB (peripheral T2a, N0), stage I

(central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), or stage IIB (T3, N0) with

negative mediastinal nodes and N1 disease; or

o adjuvant therapy for margin-positive, R1 stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b,

N1); or

o adjuvant therapy for margin-negative T1-3, N2; or

o adjuvant therapy for margin-positive, R1 stage IIIA (T1-3, N2; T3, N1); or

o adjuvant therapy for margin-positive, R1 T3 invasion or resectable T4 extension, N0-1

tumors in the chest wall, proximal airway, or mediastinum if not given as initial

treatment.

First-line therapy for recurrence or metastasis for:

o in combination with cisplatin or carboplatin in performance status (PS) 0-2 or elderly

patients; or


First-line therapy in cisplatin- or carboplatin-based regimens in combination with bevacizumab

for recurrence or metastasis in patients with performance status 0-1, tumors of nonsquamous cell

histology, and no history of recent hemoptysis.

Occult Primary

Chemoradiation in combination with carboplatin with or without etoposide in symptomatic


disease for localized disease with axillary or inguinal nodal involvement; or

Used in combination with carboplatin with or without etoposide in symptomatic patients with


PRN 8/2014

53

o lung nodules or breast marker-negative pleural effusion; or

o resectable liver disease; or


histology in selected patients; or


Used in combination with carboplatin or cisplatin in symptomatic patients with performance

status (PS) 1-2 or asymptomatic patients with PS 0 and aggressive disease for:

o chemoradiation in patients with axillary or inguinal nodal involvement; or


metastases.


Neoadjuvant chemotherapy in combination with carboplatin for bulky stage III-IV disease in poor

surgical candidates; or

Used in combination with carboplatin for:

o primary treatment for incompletely staged (stage IA-IB, grade 2-3 or clear cell and stage

IC) patients with no suspected residual disease; or

o primary adjuvant treatment for pathologic stage IA-IB (grades 2-3 or clear cell) and for


Used in combination with carboplatin with or without bevacizumab for:

o primary treatment for incompletely staged (stage II-IV) patients with suspected

unresectable residual disease; or

o primary adjuvant treatment for pathologic stage II-IV disease following completion


Intraperitoneal (IP) chemotherapy in combination with IV paclitaxel and IP cisplatin for less than

1 cm optimally debulked stage II and III disease; or

Postremission chemotherapy as a single agent for stage II-IV patients in complete clinical

remission following primary treatment; or


levels in patients who have received no prior chemotherapy; or

Therapy for persistent disease or recurrence for:

o single agent; or

o as preferred therapy, if platinum-resistant, in combination with bevacizumab if

bevacizumab not previously received.

Preferred therapy, if platinum-sensitive, in combination with carboplatin for persistent disease or

recurrence.

PRN 8/2014

54


Used as a component of TIP (paclitaxel, ifosfamide, and cisplatin) regimen as follow-up

treatment for patients with persistently elevated markers (alpha-fetoprotein and/or beta-human

chorionic gonadotrophin) following initial treatment for:

o embryonal tumor; or

o endodermal sinus tumor; or

o stage II-IV dysgerminoma; or

o stage I (grade 2-3) or stage II-IV immature teratoma.

Used as a single agent, in combination with ifosfamide, carboplatin, or gemcitabine, or in TIP

regimen for recurrent or residual disease.


Initial treatment in combination with carboplatin for:

o intermediate- and high-risk stage I disease; or

o stage II-IV disease.

Single agent or in combination with carboplatin or ifosfamide for clinical relapse in patients with

stage II-IV disease.

Penile Cancer

Used in combination with cisplatin and ifosfamide for:

o neoadjuvant treatment for enlarged (≥4 cm) biopsy positive unilateral or mobile inguinal

lymph nodes; or

o neoadjuvant treatment for enlarged (>4 cm) biopsy positive multiple or bilateral inguinal

lymph nodes; or

o neoadjuvant treatment for potentially resectable enlarged (≥4 cm) pelvic lymph nodes; or

o adjuvant treatment of tumors with high-risk pathologic features if not given

preoperatively; or

o consider for first-line treatment for locally recurrent disease in the inguinal region.

Used for the treatment of metastatic disease for:

o first-line in combination with cisplatin and ifosfamide; or

o second-line as a single agent.


Subsequent chemotherapy for patients with performance status 0-2 as a single agent for:

o relapse within 6 months following complete or partial response with initial treatment; or


PRN 8/2014

55


Used as a single agent for angiosarcoma.

Testicular Cancer

As a component of TIP regimen as second-line chemotherapy for persistent or recurrent disease

following prior chemotherapy; or

As a component of TIP regimen for treatment of residual embryonal, yolk sac, choriocarcinoma,

or seminoma elements following surgical resection of all residual masses postchemotherapy; or

High-dose chemotherapy in combination with ifosfamide followed by carboplatin and etoposide

for recurrent disease; or

As palliative chemotherapy in combination with gemcitabine with or without oxaliplatin after

second-line or high-dose chemotherapy regimens.


Postoperative treatment in combination with carboplatin and radiation therapy for:

o thymic carcinoma after R1 or R2 resection; or

o thymoma after R2 resection; or

First-line therapy in combination with carboplatin for:

o locally advanced disease; or

o isolated solitary metastasis; or

o distant metastatic disease.

Second-line therapy as a single agent following radiation therapy for locally advanced


Thyroid Carcinoma – Anaplastic Carcinoma

Used as a single agent or in combination with carboplatin for:

o use in concurrent chemoradiation

o chemotherapy for unresectable local tumor with or without distant disease.


Primary treatment as a single agent or in combination with cisplatin and doxorubicin or with

carboplatin for:

o use with sequential radiation therapy (RT) and brachytherapy with or without surgery for

extrauterine pelvic disease; or



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56

For surgically staged patients as a single agent or in combination with cisplatin and doxorubicin

or with carboplatin as adjuvant treatment for:

o use with sequential pelvic radiation therapy (RT) and/or vaginal brachytherapy in patients

with stage IB disease with histologic grade 3 tumors and adverse risk factors; or

o use with sequential pelvic RT and vaginal brachytherapy in patients with stage II disease

with histologic grade 3 tumors; or

o use with or without sequential tumor-directed RT for stage IIIA, IIIB, and IIIC disease; or

o use with or without sequential RT for stage IV disease.

Single agent or in combination with cisplatin and doxorubicin or with carboplatin as adjuvant

treatment with sequential RT and vaginal brachytherapy with or without para-aortic RT for

incompletely surgically staged patients with histologic grade 3 tumors; or

Single agent or in combination with cisplatin and doxorubicin or with carboplatin for:

o disseminated metastases that have progressed on hormonal therapy; or

o use with or without sequential palliative radiation therapy (RT) for symptomatic, grade 2-

3, or large-volume metastases; or

o use with sequential tumor-directed RT with or without brachytherapy for local recurrence

in patients with disease confined to the vagina or in pelvic, para-aortic, or common iliac

lymph nodes; or

o use with or without sequential tumor-directed RT for microscopic upper abdominal or

peritoneal recurrences; or


of recurrence.

Adjuvant therapy as a single agent or in combination with carboplatin or with cisplatin and

doxorubicin and with or without:

o vaginal brachytherapy for stage 1A disease with no myometrial invasion; or



Adjuvant therapy in combination with ifosfamide with or without:




AIDS-related Kaposi sarcoma


PRN 8/2014

57








denied.


Clinical criteria established for carboplatin (Paraplatin®)


for carboplatin (Paraplatin®). The use of carboplatin may be considered medically necessary when used

in the treatment of the following condition(s):

Bladder Cancer

As a first line alternative therapy single agent or in combination therapy for patients who cannot

receive cisplatin due to impaired renal function or other comorbidities, or

As a second-line therapy single agent if not used as a first line therapy.

Bladder Cancer-Primary Carcinoma of the Urethra



As a second line therapy single agent if not used as first line therapy.




As a second line therapy single agent if not used as a first line therapy.





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When used with a growth factor support in combination with etoposide and ifosfamide with or

without vincristine or:



o as a second line therapy for metastatic disease.


As a second line therapy in combination with etoposide and ifosfamide with growth factor

support.


As a preferred preoperative systemic therapy for patients with human epidermal growth factor

receptor 2 (HER2), or

Positive stage IIA, IIB, or T3, N1, M0 disease who desire breast preservation , or

Fulfill criteria for breast-conserving surgery except for tumor size or for locally advanced disease

(stage IIA, IIB, or IIC) in TCH (docetaxel, carboplatin, and trastuzumab) regimen alone or with

TCH regimen with pertuzumab for >=T2 or >=N1 early stage breast cancer.

As a single agent or in combination with gemcitabine for recurrent or metastatic disease that is:



o HER2-negative and wither hormone receptor –negative or hormone receptor-positive and




Used in combination with paclitaxel and trastuzumab as a first line therapy for recurrent or

metastatic human epidermal growth factor receptor 2 (HER2), positive disease or as therapy for

trastuzumab, exposed HER2-positive disease that is:


o either hormone receptor-negative or hormone receptor-positive and endocrine therapy

refractory with symptomatic visceral disease, or



PRN 8/2014

59

Central Nervous System Cancers – Adult Intracranial and Spinal Ependymoma (Excluding

Subependymoma)

As a single agent treatment or as a component of platinum based regimens for disease

progression.

Central Nervous System Cancers – Adult Low-Grade Infiltrative Supratentorial

Astrocytoma/Oligodendroglioma (excluding pilocytic astrocytoma)

As a treatment component of platinum based regimens for recurrent or progressive disease.

Central Nervous System Cancers – Adult Medulloblastoma and Supratentorial Primitive Necroectodermal

Tumors (PNET)

As a recurrence/salvage therapy in combination with etoposide and cyclophosphamide for disease

progression in patients who have not received prior chemotherapy.

Central Nervous System Cancers – Anaplastic Gliomas

In the treatment of recurrent disease or salvage therapy in platinum based chemotherapy regimens

or in combination with bevacizumab.

Central Nervous System Cancers – Glioblastoma

In the treatment of recurrent disease, or salvage therapy in platinum based chemotherapy

regimens, or in combination with bevacizumab.

Cervical Cancer

As a first line therapy when used as a single agent or in combination with paclitaxel for:


o distant metastases


For the use of locoregional disease in medically fit patients and in combination with paclitaxel as

a preferred regimen and:

o definitive chemoradiation for patients who decline surgery and are recommended for

cervical esophagus squamous cell carcinoma for T1b, N+ or T2-4a, N0-N+ , or

o definitive chemoradiation for T4a.

For medically unfit patients with T1b, N0 tumors with poor prognostic features, or

As a primary treatment for T1b, N+, T2-T4a, or unresectable T4b disease for patients who are

unfit for or do not elect surgery.

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As a concurrent chemoradiation in combination with paclitaxel as a preferred regimen for

locoregional recurrence in patients who have had surgery but no prior chemoradiation.

As palliative therapy for patients with Karnofshy performance score >=60%, or ECOG

performance score <=2 in combination with paclitaxel, or as a component of preferred modified

DCF (docetaxel, carboplatin and fluorouracil) regimen as a first line therapy for the following:






Gastric Cancer

As a preoperative chemoradiation for resectable locoregional disease. (T2 or higher by clinical

staging any N) in medical fit patients.


As a primary concurrent chemoradiation for non-nasopharyngeal cancer for:

o patients with performance status (PS) 0-2 who have newly diagnosed T4b and any N,

unresectable nodal disease with no metastases, or who are unfit for surgery, or

o locoregional recurrence is PS 0-2 patients who have not received prior radiation therapy.

For sequential chemoradiation following induction chemotherapy in performance status 0-1

patients with non-nasopharyngeal disease for :

o newly diagnosed T4b and any N, or unresectable nodal disease with no metastases, or

patients unfit for surgery, or


therapy.

As a single agent for patients with performance status (PS) 3, with newly diagnosed T4b and any

N, unresectable nodal disease with no metastases, or with unresectable locoregional recurrence,

no prior radiation therapy (RT), and for patient who are unfit for surgery, or

As a single agent for PS-02 patients, or in combination (PS0-1) with paclitaxel, docetaxel, or

cetuximab (nasopharyngeal cancer) for the treatment of unresectable locoregional recurrence, or

as a secondary primary in patients who have received prior RT, or for distant metastases.


As a primary concurrent chemoradiation in combination with paclitaxel for the treatment of:


PRN 8/2014

61

o considered for selected T4a patients who decline surgery.

For sequential chemoradiation for:

o T3, N0-3 disease requiring (amenable to ) total laryngectomy following partial response

at the primary site to induction chemotherapy, or

o for selected T4a patients who decline surgery following partial response at the primary

site to induction chemotherapy.



o T1, N+, or

o T2-3, and any N Disease requiring (amenable to) pharyngectomy with total

laryngectomy,.


o T1, N+ with partial response at the primary site and stable or improved disease in the

neck following induction chemotherapy, or

o T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy with

partial response at the primary site and stable, or improved disease in the neck following

induction chemotherapy, or

o T4a, any N disease with partial response at the primary site and stable or improved

disease in the neck following induction chemotherapy, or

o can be considered for T1, N+, for T2-3, any N requiring (amenable to) pharyngectomy

with total laryngectomy, or for T4a, any N disease with complete response at the primary

site and stable, or improved disease in the neck following induction chemotherapy.


As a primary concurrent chemoradiation in combination with paclitaxel for patients with T3-4a,

N0, or for patients with any T, N1-3 disease who are candidates for but do not receive surgery.


As an adjuvant therapy in combination with fluorouracil following chemoradiation for:



For sequential chemoradiation for :

o T1, N1-3 disease

o T2-4 and N disease.

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62

As a primary platinum based chemotherapy in combination with docetaxel, paclitaxel, or

cetuximab for any T, any N, or M1 disease,

As chemoradiation following platinum based chemotherapy for any T, any N, or M1 disease.


As a primary concurrent chemoradiation in combination with paclitaxel for treatment of:

o T2, N1 disease, or


o any T, N2-3 disease,

For sequential chemoradiation following induction chemotherapy for:




As a primary concurrent chemoradiation in combination with paclitaxel for:


o T1-2, N+ and selected T3, N1 disease amenable to larynx preserving (conservation)

surgery, or

o for T4a, N0-3 patients who decline surgery.


o T3, N0 and most T3, N2-3 disease requiring (amenable to) total laryngectomy following

partial response at the primary site to induction chemotherapy, or


surgery following partial response at the primary site to induction chemotherapy, or

o T4a, N0-3 patients who decline surgery with a partial response at the primary site to

induction chemotherapy.



o newly diagnosed T3-4a disease, or

o for patients who have declined surgery, or

o for cancer diagnosed after incomplete excision with gross residual disease.


For preoperative concurrent chemoradiation in combination with paclitaxel in select patients with

T3-4a, or N0 disease.

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63

As a primary concurrent chemoradiation in combination with paclitaxel for T4b and any N

disease.


As the initial definitive treatment in:

o concurrent chemoradiation for >=N2 disease in combination with paclitaxel, or

o as sequential chemoradiation.

Hodgkin Lymphoma – Classical Hodgkin Lymphoma

When used as a component of GCD (gemcitabine, carboplatin and dexamethasone) or ICE

(ifosfamide, carboplatin and etoposide) regimen:

o as a second line therapy prior to autologous stem cell rescue for refractory disease, or

o as a salvage therapy with or without ISRT prior to autologous stem cell rescue, or

o as a second line therapy with or without ISRT for stage IA-IIA relapsed disease in

patients with no prior RT and failure at initial sites, or

o as a second line therapy for all other relapsed disease.

Hodgkin Lymphoma – Nodular Lymphocyte-Predominant Hodgkin Lymphoma

As a second line therapy with or without rituximab for symptomatic refractory or relapsed disease

as a component of:

o GCD regimen, or

o ICE regimen.

Kidney Cancer

When used in combination with gemcitabine or paclitaxel for patients with collecting duct or

medullary subtypes.


When used in combination with pemetrexed for:

o unresectable stage III in transit metastases, or

o local/satellite and/or in transit unresectable recurrence, or

o incompletely resected or unresectable nodal recurrence, or


Melanoma

When used in combination with paclitaxel for:


PRN 8/2014

64




Neuroendocrine Tumors – Adrenal Gland Tumors

When used as treatment for metastatic adrenal carcinoma in combination with etoposide with or

without doxorubicin or miltotane.

Neuroendocrine Tumors-Poorly Differentiated (High-Grade)/Large or Small Cell

When used as the primary treatment for:

o resectable disease, or

o unresectable locoregional disease, or

o metastatic disease.

Non-Hodgkin Lymphoma (NHL) – Adult T-Cell Leukemia/Lymphoma

When used for nonresponders to first line therapy for acute disease or lymphoma in candidates

for transplant as a component of ICE regimen.

NHL-AIDS – Related B-Cell Lymphoma

When used as a second line therapy with or without rituximab for relapse of AIDS related diffuse

large B-cell lymphoma, primary effusion lymphoma, and lymphoma associated with Castleman’s

disease in patients with intention to proceed to high-dose therapy with autologous stem cell

rescue and as a component of:

o ICE regimen, or

o GDP regimen.

NHL – Burkitt Lymphoma

When used as a second line therapy for relapse of Burkitt lymphoma following complete response

as a component of RICE (rituximab, ifosfamide, carboplatin, and etoposide) regimen with

intrathecal methotrexate if not previously given.

NHL – Diffuse Large B-Cell Lymphoma

As a second line therapy with or without rituximab for relapsed or refractory disease in patients

with intention to proceed to high dose therapy with autologous stem cell rescue as a component

of:

o ICE regimen, or

o GDP regimen.

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65

Used to treat primary mediastinal large B-cell lymphoma as a component of ICE regimen

following RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

regimen.

NHL – Extranodal NK/T-Cell Lymphyoma, nasal type

When used for induction therapy as a component of DeVIC (dexamethasone, etoposide,

ifosfamide, and carboplatin) regimen with concurrent radiation.

NHL – Follicular Lymphoma

When used as a second line or subsequent therapy with or without rituximab for recurrent or

progressive disease in patients with the indications for treatment as a component of:

o ICE regimen, or

o GDP regimen.

NHL – Gastric MALT Lymphoma

When used as a second line therapy with or without rituximab for recurrent or progressive disease

in patients with the indications for treatment as a component of:

o ICE regimen, or

o GDP regimen.

NHL – Mantle Cell Lymphoma

When used as induction therapy and a component of aggressive therapy with sequential

RCHOP/RICE (rituximab, cyclophosphamide, vincristine, doxorubicin, and

prednisone)/(rituximab, ifosfamide, carboplatin, and etoposide) regimen.

As a second line therapy with or without rituximab for relapsed, refractory, or progressive disease

as a component of:

o ICE regimen, or

o GDP regimen.

NHL – Mycosis Fungoides (MF)/Sezary Syndrome (SS)

Chemotherapy when used for tumors with histologic evidence of large cell transformation and

aggressive growth rate as a component of ICE regimen in candidates for transplant with:

o stage IA-IIA MF with histologic evidence of folliculotropic or large cell transformation

or stage IIB with generalized extended tumor, transformed, and/or folliculotropic disease

in combination with skin direct therapy, or

o state IV non-Sezary or visceral disease.

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66

NHL – Nongastric MALT Lymphoma

As a second line therapy with or without rituximab for recurrent stage I-II disease or for


o ICE regimen, or

o GDP regimen.

NHL – Peripheral T-Cell Lymphoma

As a first line therapy for patients with angioimmunoblastic T-cell lymphoma, peripheral T-cell

lymphoma not otherwise specified, ALK-negative anaplastic large cell lymphoma, or

enteropathy-associated T-cell lymphoma as a component of ICE regimen following CHOP

(cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen.

As a second line therapy for relapsed or refractory angioimmunoblastic T-cell lymphoma,

peripheral T-cell lymphoma not otherwise specified, anaplastic large cell lymphoma, or

enteropathy associated T-cell lymphoma in candidates for transplant as a component of ICE

regimen.

NHL – Primary Cutaneous B-Cell Lymphoma

As a second line therapy with or without rituximab for primary cutaneous marginal zone or

follicle center lymphoma as a component of ICE or GDP regimen for:

o refractory generalized cutaneous disease, or

o relapsed generalized extracutaneous disease.

Second line therapy with or without rituximab for relapsed or refractory primary cutaneous

diffuse large B-cell lymphoma, leg type in patients with intention to proceed to high-dose therapy

with autologous stem cell rescue as a component of:

o ICE regimen, or

o GDP regimen.

NHL – Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders

As a component of ICE regimen for relapsed or refractory:

o primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or

o cutaneous ALCL with regional nodes (excludes systemic ALCL).

NHL – Splenic Marginal Zone Lymphoma

As a second line therapy with or without rituximab for progressive disease in patients with the

indications for treatment as a component of:

o ICE regimen, or

o GDP regimen.

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67

Non-Melanoma Skin Cancers – Merkel Cell Carcinoma

When used as a single agent or in combination with etoposide as:

o a consideration for adjuvant treatment with or without radiation therapy for clinical N+

disease in select clinical circumstances, or

o treatment for distant metastatic disease or disseminated recurrence with or without

surgery or radiation.


When used as a preoperative concurrent chemoradiation in combination with pemetrexed for

patients with comorbidities or who are unable to tolerate cisplatin for:


1), or


or the mediastinum.

Used as a preoperative concurrent chemoradiation in combination with paclitaxel for patients

with comorbidities or who are unable to tolerate cisplatin followed by chemotherapy with 2

cycles of paclitaxel and carboplatin for T3 invasion, resectable T4 extension, N0-1 disease in the

chest wall, proximal airway, or mediastinum.

Used in combination with paclitaxel for patients with comorbidities or who are unable to tolerate

cisplatin as:






chemotherapy.

Used for initial treatment as a definitive concurrent chemoradiation in combination with

pemetrexed for patients with comorbidities or who are unable to tolerate cisplatin for:



N1 disease, or




PRN 8/2014

68


paclitaxel for patients with comorbidities or who are unable to tolerate cisplatin followed by

chemotherapy with 2 cycles of paclitaxel and carboplatin for:



N1 disease, or




As an adjuvant chemotherapy in combination with paclitaxel for patients with comorbidities or

who are unable to tolerate cisplatin for:

o definitive radiation therapy in medically inoperable high risk stage IB (peripheral T2a,

N0), stage I (central T1ab-2a, N0), stage II (T1ab- 2ab, N1; T2b, N0), or stage IIB (T3,

N0) with negative mediastinal nodes and N0 disease, or

o for high risk, margin negative stage IB (T2a, N0) and IIA (T2b, N0, or)

o for margin positive stage IB (T2a, N0) and IIA (T2b, N0), or

o for margin positive stage IIA (T2b, N0) following radiation, or


o for margin negative stage IIIA (T1-3, N2; T3, N1), or


N0-1), or


airway, and the mediastinum if not given as initial treatment, or

o for margin negative or margin positive, R1 T1-3 (including T3 with multiple nodules in




(T4), N0-1, or

o for margin negative or margin positive, R1 separate pulmonary nodule(s) in the same


As an adjuvant concurrent chemoradiation in combination with paclitaxel followed by


o margin positive stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1), or

o margin positive stage IIIA (T1-3, N2; T3, N1), or

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69

o margin positive T3 invasion or resectable T4 extension, N0-1 tumors in the chest wall,


o margin positive T1-3 (including T3 with multiple nodules in the same lobe), N2, or

o margin positive separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral


As an adjuvant concurrent chemoradiation in combination with pemetrexed for:








Or as a sequential chemoradiation in combination with paclitaxel as:

o the initial definitive therapy for medically inoperable stage IB (peripheral T2a, N0), stage

I (central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), or stage IIB (T3, N0) with

negative mediastinal nodes and N1 disease, or


N1), or,

o adjuvant therapy for margin negative T1-3, N2, or

o adjuvant therapy for margin positive, R1 stage IIIA (T1-3, N2; T3, N1), or

o adjuvant therapy for margin positive, R1 T3 invasion or resectable T4 extension, N0-1


treatment.

As concurrent chemoradiation in combination with pemetrexed if radiation not previously given

for locoregional recurrence in the mediastinal lymph nodes or for superior vena cava obstruction.

o as a first line therapy for recurrence or metastasis:

o in combination with paclitaxel, docetaxel, gemcitabine, vinorelbine, etoposide,

vinblastine, pemetrexed (nonsquamous cell histology), or with albumin bound paclitaxel

in patients with performance status (PS) 0-2, or the elderly patient, or

o as a single agent in PS 2 or the elderly patient.

As a first line therapy for recurrence or metastasis in a carboplatin based regimen in combination

with bevacizumab in patients with performance status (PS) 0-1, tumors of nonsquamous cell


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70

As a second line therapy for progression in patients with multiple symptomatic systemic lesions

in carboplatin based doublet therapy with or without bevacizumab:

o with or without erlotinib for sensitizing EGFR mutation positive tumors and prior

erlotinib or afatinib therapy, or

o for ALK-positive tumors and prior crizotinib and/or ceritinib therapy.

Occult Primary

For chemoradiation in combination with docetaxel or with paclitaxel with or without etoposide in


aggressive disease for localized disease with axillary or inguinal nodal involvement.

May be used in combination with docetaxel, or with paclitaxel with or without etoposide in

symptomatic patients with performance status (PS) 1-2, or asymptomatic patients with PS 0 and


o lung nodules or breast marker negative pleural effusion, or





Used in combination with paclitaxel or docetaxel in symptomatic patients with performance




metastases.

Ovarian Cancer – Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary peritoneal Cancer

When used as a neoadjuvant chemotherapy in combination with paclitaxel or docetaxel for bulky

stage III-IV disease in poor surgical candidates.

Used in combination with paclitaxel or docetaxel as:





Used in combination with paclitaxel or with docetaxel as:



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71



In combination with paclitaxel or docetaxel for clinical relapse or recurrent disease as evidenced

by rising CA-125 levels in patients who have received no prior chemotherapy.

As a preferred therapy, if platinum sensitive, for persistent disease or recurrence:


o in combination with docetaxel, gemcitabine, or liposomal doxorubicin, or

o in combination with gemcitabine and bevacizumab if bevacizumab not previously

received.


When used in the initial treatment and in combination with etoposide or irinotecan for extensive

stage disease.

When used in combination with etoposide in patients with limited stage disease who are poor

candidates for cisplatin as:

o an initial treatment with or without radiation, or

o an adjuvant chemotherapy for pN0 disease, or

o an adjuvant concurrent chemoradiation for pN+ disease.

As a subsequent chemotherapy for patients with performance status 0-2 in combination with

etoposide or irinotecan and:

o if used as the original regimen, for relapse occurring more than 6 months following

complete or partial response or stable disease with initial treatment, or

o if not used as original regimen, for primary progressive disease.

Soft Tissue Sarcoma – Rhabodomyosarcoma

As therapy when used in combination with etoposide for nonpleomorphic rhabodomyosarcoma.

Testicular Cancer

As a high dose chemotherapy in combination with etoposide alone or following paclitaxel and

ifosfamide for recurrent disease.

As a primary treatment and a single agent for patients with stage 1A-B disease.


When used as a postoperative treatment in combination with paclitaxel and radiation therapy for:

o thymic carcinoma after R1 or R2 resection, or

o thymoma after R2 resection.

As a first line therapy in combination with paclitaxel for:

PRN 8/2014

72

o locally advanced disease, or

o isolated solitary metastasis, or



When used in combination with paclitaxel and:

o in concurrent chemoradiation, or

o as chemotherapy for unresectable local tumors with or without distant disease.


When used as a primary treatment and a single agent or in combination with paclitaxel or

docetaxel when used:



o can be considered following palliative hysterectomy with bilateral salpingo-

oophorectomy with or without RT and/or hormonal therapy for extra abdominal or liver

disease.

For surgically staged patients as a single agent, or in combination with paclitaxel, or with

docetaxel as an adjuvant treatment:


with stage IB disease and histologic grade 3 tumors and adverse risk factors, or



o with or without sequential tumor directed RT for stage IIIA, IIIB, and IIIC disease, or

o with or without sequential RT for stage IV disease, or

o as a single agent or in combination with paclitaxel, or docetaxel as adjuvant treatment

with sequential RT and vaginal brachytherapy with or without para-aortic RT for

incompletely surgically staged patients with histologic grade 3 tumors.

Single agent or in combination with paclitaxel or docetaxel:



or large-volume metastases, or

o with sequential tumor directed RT with or without brachytherapy for local recurrence in

patients with disease confined to the vagina, or in the pelvic, the para-aortic, or common

iliac lymph nodes, or

PRN 8/2014

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of recurrence.

As an adjuvant therapy single agent or in combination with paclitaxel or docetaxel and with or

without:


o sequential tumor directed radiation therapy for stage 1A disease with myometrial



When used in combination with docetaxel or paclitaxel for recurrent or residual disease.



o considered for initial treatment of intermediate and high-risk stage I disease, or

o for initial treatment of stage II-IV disease, or

o for clinical relapse in patients with stage II-IV disease.

Penile Cancer

When used in combination with etoposide for treatment of distant metastases with small cell

features.

Prostate Cancer


feature.









denied.

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Criteria revised for surgical treatment of varicose veins

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will revise the clinical criteria for surgical

treatment of varicose veins.

Throughout this policy, the mathematical signage “≥ “was revised to the traditional use of wording of at

least. The cutoff value for abnormally reversed venous flow (reflux) in the saphenous, tibial, deep femoral

and perforating vein incompetence is defined as at least 500 ms (500 milliseconds outward flow). The

cutoff value for femoral and popliteal vein incompetence is defined as at least 1 second.

Subfascial endoscopic perforator surgery (SEPS) medical necessity criteria and SEPS definition revised.

Perforator veins

Subfascial endoscopic perforator surgery may be considered medically necessary as a treatment of leg

ulcers associated with chronic venous insufficiency when the following conditions have been met:

There is demonstrated perforator reflux; and

The superficial saphenous veins (GSV, SSV, or accessory saphenous and symptomatic varicose

tributaries) have been previously eliminated; and

Ulcers have not resolved following combined superficial vein treatment and compression therapy

for at least 3 months; and

The venous insufficiency is not secondary to deep venous thromboembolism (DVT).

Ligation or ablation of incompetent perforator veins performed concurrently with superficial venous

surgery is not medically necessary.

SEPS definition: When a patient has chronic venous insufficiency severe enough to cause leg ulcers there

are almost always refluxing connecting or “perforating” veins between the deep and superficial vein

systems. SEPS is a surgical procedure to treat these perforating veins. During the SEPS procedure

abnormal perforating veins are disconnected. This allows blood flow to be directed into normal veins, and

allows healing of the ulcer





PRN 8/2014

75




denied.

Please refer to Medical Policy S-55, Surgical Treatment of Varicose Veins, for additional information.

Diagnosis codes revised for aqueous shunts and stents for glaucoma

Highmark Blue Cross Blue Shield is revising diagnosis codes for wearable defibrillators. The new

guidelines will become effective Oct. 27, 2014.

Diagnosis codes for aqueous shunts and stents for glaucoma have been revised. These diagnosis codes

will affect procedure codes 66175, 0191T, and 0253T.


New coverage for opioid dependence therapy

Highmark Blue Cross Blue Shield is updating its coverage criteria for opioid dependence therapy. The

new guidelines will become effective on Oct. 27, 2014.

Treatment of opioid dependence therapy using buprenorphine’s (Suboxone®, Subutex, or Zubsolv) may

be considered medically necessary when the following criteria are met.

1. Diagnosis of opioid dependence; and

2. Adults and adolescents greater than 16 years of age; and

3. The provider has provided a treatment plan and taper strategy, and

4. The treating physician must hold one of the following:

A subspecialty board certification in addiction psychiatry from the American Board of

Psychiatry and Neurology; or

An addiction certification from the American Society of Addiction Medicine (ASAM); or

A subspecialty board certification in addiction medicine from the American Osteopathic

Association (AOA); or

Has completed more than 8 hours of training on the treatment and management of opioid

dependent patients from the American Academy of Addiction Psychiatry, the American

PRN 8/2014

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Medical Association, the American Osteopathic Association, or the American Psychiatric

Association; and

Registration number and unique identification number form the Drug Enforcement

Agency (DEA).

Treatment of opioid dependence therapy shall consist of the following time frames in this order:

Assessment and Treatment Planning (90791, 90792, 99213)

o 1 - 2 office visits weekly for the 4 weeks of initiation of therapy

Induction (99205, 99215)

o 3 office visits per week for 2 weeks

Stabilization (90833, 90836, 90863)

o 1 - 2 office visits per week for 8 weeks

Maintenance (90862)

o 1 office visit per month

Treatment is for a period of up to 1 year.

Refer to Pharmacy Policy J-23 for drug coverage criteria under the pharmacy benefit.








denied.

Please refer to Medical Policy Y-22 for more information.

Elaprase® criteria updated

Highmark Blue Cross Blue Shield updated its coverage criteria for idursulfase (Elaprase®). The new

guidelines became effective July 7, 2014.

Idursulfase (Elaprase®) is indicated for use in patients 5 years old and older with Hunter syndrome

(Mucopolysaccharidosis II, MPS II).

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77


Clinical criteria established for bendamustine (Treanda®)

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will create a policy with clinical criteria for

bendamustine (Treanda®). The use of bendamustine (Treanda) may be considered medically necessary

when used in the treatment of the following condition(s):

Hodgkin lymphoma

Classical Hodgkin lymphoma for:

o third-line therapy or salvage therapy as a single agent prior to autologous stem cell rescue

for progressive disease or for relapsed disease in patients initially treated with

chemotherapy, with or without radiation therapy.

Lymphocyte-predominant Hodgkin lymphoma (LPHL) for:

o second-line therapy, with or without rituximab (Rituxan®), for symptomatic progressive

disease or for relapsed disease.

Multiple myeloma for

Salvage therapy on or off clinical trials for disease relapse or for progressive or refractory disease,

as a single agent or in combination with lenalidomide and dexamethasone.

Non-Hodgkin lymphoma (NHL)

Chronic lymphocytic leukemia (CLL), including hairy cell leukemia and small lymphocytic

lymphoma (SLL), without del(17p) or with or without del(11q) for:

o as first-line therapy with or without rituximab (Rituxan) for stage II-IV disease (as

referenced in the Rai Staging System or Benet Classification for CLL); or

o with or without rituximab (Rituxan) for relapsed or refractory disease.

Indolent B-cell lymphoma for:

o for progressive disease during or within six months of treatment with rituximab (Rituxan)

or a rituximab-containing regimen.

AIDS-related B-cell lymphoma for:

o non-candidates of high-dose therapy; or

o second-line therapy for relapsed disease, with or without rituximab (Rituxan).

Diffuse large B-cell lymphoma for:

o second-line therapy with or without rituximab for relapsed or refractory disease in

noncandidates for high-dose therapy.

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78

Follicular lymphoma and nodal marginal zone lymphoma for:

o first-line therapy with rituximab (Rituxan); or

o second-line or subsequent therapy, with or without rituximab (Rituxan).

Gastric MALT (mucosa-associated lymphoid tissue) lymphoma for:

o first-line therapy for stage IIIE-IV disease in combination with rituximab

o second-line therapy for recurrent or progressive disease as a single agent or in

combination with rituximab.

Mantle cell lymphoma for:

o with rituximab (Rituxan) as a less-aggressive induction therapy; or

o second-line therapy with or without rituximab (Rituxan) for relapsed, refractory, or

progressive disease.

Non-gastric MALT lymphoma for:

o first-line therapy for stage III-IV disease with rituximab (Rituxan); or

o second-line therapy for recurrent stage I-II disease or for progressive disease, with or

without rituximab (Rituxan).

Primary cutaneous B-cell lymphoma-Primary cutaneous marginal zone or follicle center B-cell

lymphoma for:

o first-line therapy for newly diagnosed generalized extracutaneous disease with rituximab

(Rituxan); or

o second-line therapy for refractory generalized cutaneous disease or relapsed generalized

extracutaneous disease, with or without rituximab (Rituxan), or as a component of BVR

(bendamustine, bortezomib, and rituximab) regimen.

Primary cutaneous diffuse large B-cell lymphoma, leg type in noncandidates for high-dose

therapy for:

o second-line therapy for relapsed or refractory disease, with or without rituximab

(Rituxan).

Splenic marginal zone lymphoma for:

o first-line therapy with rituximab (Rituxan) for disease progression following initial

treatment for splenomegaly; or

o second-line therapy for progressive disease, with or without rituximab (Rituxan).

Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma

Used with or without rituximab for:

o primary therapy; or

o salvage therapy for disease that does not respond to primary therapy or for progressive or

relapsed disease.

PRN 8/2014

79









denied.


Non-invasive open ventilation (NIOV) system is considered

experimental/investigational

Effective Oct. 27 1, 2014, Highmark Blue Cross Blue Shield will consider non-invasive open ventilation

(NIOV) system experimental/investigational. The safety and/or effectiveness of this service cannot be

established by review of the available published peer-reviewed literature.

A participating, preferred, or network provider can bill the member for the denied service.


Clinical criteria established for cetuximab (Erbitux®)

Effective Oct 27, 2014, Highmark Blue Cross Blue Shield will create a new policy with clinical criteria

for cetuximab (Erbitux®). The use of cetuximab may be considered medically necessary when used in the

treatment of the following condition(s):

Colon Cancer

Used in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen for tumors

expressing KRAS/NRAS wild-type gene for:

o perioperative therapy for patients with synchronous liver and/or lung metastases or for

patients with resectable metachronous metastases who received previous chemotherapy;

or

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o therapy for patients with unresectable synchronous liver and/or lung metastases, with

synchronous abdominal/peritoneal metastases, or with unresectable metachronous

metastases; or

Therapy for patients with unresectable metachronous metastases and previous adjuvant FOLFOX

(fluorouracil, leucovorin, and oxaliplatin) within the past 12 months in combination with

irinotecan for tumors expressing KRAS/NRAS wild-type gene; or

Initial therapy for patients with tumors expressing KRAS/NRAS wild-type gene who have

unresectable advanced or metastatic disease for:

o in combination with FOLFIRI regimen for patients who can tolerate intensive therapy; or

o as a single agent for patients who cannot tolerate intensive therapy; or

Therapy for patients with tumors expressing KRAS/NRAS wild-type gene who have unresectable

advanced or metastatic disease and have not previously received cetuximab or panitumumab:

o as a single agent or in combination with irinotecan after first progression in patients

previously receiving irinotecan-based regimens; or

o in combination with irinotecan or with FOLFIRI regimen after first progression in

patients who previously received oxaliplatin-based regimens with or without

bevacizumab; or

o as a single agent or in combination with irinotecan after second progression.

Head and Neck Cancers - Advanced, Recurrent, Persistent

Primary concurrent chemoradiation for non-nasopharyngeal cancer as a single agent for:



o locoregional recurrence in PS 0-2 patients who have not received prior radiation therapy;

or

Sequential chemoradiation following induction chemotherapy in performance status 0-1 patients

with non-nasopharyngeal cancer for:

o newly diagnosed T4b, any N or unresectable nodal disease with no metastases, or patients



therapy; or

Therapy as a:

o single agent for patients with non-nasopharyngeal cancer with performance status (PS) 3

with newly diagnosed T4b, any N, unresectable nodal disease with no metastases, or with

unresectable locoregional recurrence and no prior radiation therapy (RT) or for patients

who are unfit for surgery; or

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81

o single agent (non-nasopharyngeal cancer) in PS 0-2 patients or in combination (PS 0-1)

with carboplatin with (non-nasopharyngeal cancer) or without (nasopharyngeal cancer)

fluorouracil, in combination with cisplatin with or without fluorouracil, docetaxel, or

paclitaxel (non-nasopharyngeal cancer), for unresectable locoregional recurrence or

second primary in patients who have received prior RT or for distant metastases.

Head and Neck Cancers - Cancer of the Glottic Larynx

Primary concurrent chemoradiation as a single agent for:


o consider for selected T4a patients who decline surgery; or

Sequential chemoradiation:

o for T3, N0-3 disease requiring (amenable to) total laryngectomy following partial

response at the primary site to induction chemotherapy; or



Head and Neck Cancers - Cancer of the Hypopharynx


o T1, N+; or


o T4a, any N disease; or


o for T1, N+ with partial response at the primary site and stable or improved disease in the

neck following induction chemotherapy; or

o for T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy

with partial response at the primary site and stable or improved disease in the neck

following induction chemotherapy; or

o for T4a, any N disease with partial response at the primary site and stable or improved

disease in the neck following induction chemotherapy; or

o consider for T1, N+, for T2-3, any N requiring (amenable to) pharyngectomy with total

laryngectomy, or for T4a, any N disease with complete response at the primary site and

stable or improved disease in the neck following induction chemotherapy.

Head and Neck Cancers - Cancer of the Lip

Primary concurrent chemoradiation as a single agent for patients with T3-4a, N0 or for patients

with any T, N1-3 disease who are candidates for but do not receive surgery.

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82

Head and Neck Cancers - Cancer of the Nasopharynx

Primary therapy in combination with carboplatin for any T, any N, M1 disease.

Head and Neck Cancers - Cancer of the Oropharynx




o any T, N2-3 disease; or

Sequential chemoradiation following induction chemotherapy for:



Head and Neck Cancers - Cancer of the Supraglottic Larynx




surgery; or

o consider for T4a, N0-3 patients who decline surgery; or

Sequential chemoradiation for:


partial response at the primary site to induction chemotherapy;


surgery following partial response at the primary site to induction chemotherapy;



Head and Neck Cancers - Ethmoid Sinus Tumors





Head and Neck Cancers - Maxillary Sinus Tumors

Consider preoperative concurrent chemoradiation as a single agent for select patients with T3-4a,

N0; or

Primary concurrent chemoradiation as a single agent for T4b, any N.

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83

Head and Neck Cancers - Occult Primary

Initial definitive treatment as:

concurrent chemoradiation for ≥N2 disease; or

sequential chemoradiation.

Non-Melanoma Skin Cancers - Basal Cell and Squamous Cell Skin Cancers

Treatment of squamous cell skin cancer for regional recurrence or distant metastases.


First-line therapy for recurrence or metastasis in combination with vinorelbine and cisplatin in

patients with performance status 0-1; or

Single-agent continuation maintenance therapy if given first line with chemotherapy for

recurrence or metastasis in patients with performance status 0-1 who achieve tumor response or

stable disease following first-line chemotherapy.

Rectal Cancer

Used in combination with FOLFIRI regimen for tumors expressing KRAS/NRAS wild-type gene

as:

o neoadjuvant therapy for patients with synchronous metastases; or

o adjuvant therapy for patients with resected synchronous metastases who received

neoadjuvant chemoradiation ; or

o perioperative therapy for patients with resectable metachronous metastases who received

previous chemotherapy; or

o therapy for patients with unresectable metachronous metastases; or

o primary therapy for patients with unresectable synchronous metastases or who are

medically inoperable; or


within the past 12 months in combination with irinotecan for tumors expressing KRAS/NRAS

wild-type gene; or

Initial therapy for patients with tumors expressing KRAS/NRAS wild-type gene who have T4

and/or locally unresectable or medically inoperable disease or have unresectable advanced or

metastatic disease:

o in combination with FOLFIRI regimen for those who can tolerate intensive therapy; or




PRN 8/2014

84





bevacizumab; or










denied.


Donor leukocyte infusion approved for multiple myeloma

Effective Sept. 1, 2014, Highmark Blue Cross Blue Shield will revise the criteria for donor leukocyte

infusion for hematologic malignancies that relapse after allogeneic stem-cell transplant as follows:

Donor lymphocyte infusion (38242) may be considered medically necessary for adults and children

following allogeneic-hematopoietic stem cell transplantation (HSCT) that was originally considered

medically necessary for the treatment of a hematologic malignancy that does not respond, has relapsed or

is refractory, to prevent relapse in the setting of a high risk of relapse, or to convert a patient from mixed

to full donor chimerism with ANY ONE of the following conditions:

Individuals with acute myeloid leukemia; or

Individuals with chronic myeloid leukemia, or

Individuals with Hodgkin's disease; or

Individuals with acute lymphocytic leukemia; or

Individuals with multiple myeloma.

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85

Other applications of donor infusions are considered experimental/investigational. A participating,

preferred, or network provider can bill the member for the denied service.


Skin allergy testing coverage criteria expanded to include

eosinophilic esophagitis

Effective Oct. 27, 2014, eosinophilic esophagitis will be a covered diagnosis for allergy testing as per the

following criteria:

In vivo allergy tests fall into two general categories: skin tests and provocation tests. Both are designed to

confirm hypersensitivity and identify the antigen(s) responsible for the allergic reaction. The efficacy of

some in vivo allergy tests has not been firmly established, due to the limited numbers of well-designed

clinical trials. Few prospective studies are available, and evidence is primarily in the form of expert

opinion.

Titration (SET) used in conjunction with immuno-therapy may be medically necessary with ANY ONE of

the following criteria when there is potential for the specific allergen in question to produce a severe

systemic allergic reaction or anaphylaxis:

To determine a safe starting dose for testing.

Allergy testing may be considered medically necessary in the diagnosis of allergies or eosinophilic

esophagitis by ANY ONE of the following tests:

Direct Skin Test with ANY ONE of the following techniques:

o percutaneous (scratch, prick, or puncture) up to 70 tests per patient per year (365 day

period). Payment should not be made in excess of this limit except in extraordinary

circumstances. Services exceeding this limitation are considered not medically necessary;

o intracutaneous (intradermal) up to 70 tests per patient per year (365 day period) Payment

should not be made in excess of this limit except in extraordinary circumstances. Services

exceeding this limitation are considered not medically necessary

OR

Patch Test (Application Test) for diagnosing contact dermatitis or eosinophilic esophagitis; or

Photo Patch Test for diagnosing a photo-allergy(e.g., photo-allergic contact dermatitis); or

Bronchial Challenge Tests to diagnose ANY ONE of the following:

o to identify new allergens for which skin or blood testing has not been validated; or

PRN 8/2014

86

o skin testing is unreliable; or

Oral Challenge Tests for any of the following:

o food or other substances (i.e. additives or preservatives); or

o drugs when ALL of the following are met:

an allergy to multiple classes of drugs within a drug category is suspected (i.e.,

allergic to penicillin, and cephalosporins);

AND

there is no effective alternative drug; or

treatment with that drug is essential.

Skin Endpoint Titration (SET) used in conjunction with immuno-therapy may be medically necessary

with ANY ONE of the following criteria when there is potential for the specific allergen in question to

produce a severe systemic allergic reaction or anaphylaxis:

To determine a safe starting does for testing; or

To determine a safe starting dose for immuno-therapy.

Allergy testing methods with ANY ONE of the following are considered not medically necessary. A

participating, preferred, or network provider cannot bill the member for the denied service.

Cytotoxic food testing (95199); or

Leukocyte histamine release (86343); or

Provocative testing, e.g., Rinke (95199)l; or

Sublingual (antigens prepared for sublingual administration) (95199); or

Mucous membrane test (e.g., direct nasal, ophthalmic) (95060, 95065).








denied.

Refer to Medical Policy L-3 for information on in vitro allergy testing.

Please refer to Medical Policy Z-26 for more information.

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87

Electrical stimulation therapy for chronic ulcers is limited to an hour

per day

Effective Oct. 27, 2014, the criteria for electrical stimulation and electromagnetic therapy for chronic

ulcers changes as follows:

Electrical stimulation for the treatment of wounds is the application of electrical current through

electrodes placed directly on the skin in close proximity to the wound.

Electrical stimulation (G0281) is covered for the management of the following types of chronic ulcers

when it is used as adjunctive therapy after there are no measurable signs of healing for at least 30 days of

treatment with conventional wound treatments (Electrical stimulation will not be covered as an initial

treatment modality.):

Arterial ulcers;

Diabetic ulcers;

Pressure ulcers (Stage III or Stage IV);

Venous stasis ulcers.

A course of electrical stimulation therapy for chronic ulcers would not typically be expected to exceed 60

minutes per day, or a total duration of more than one month. Courses of electrical stimulation therapy for

chronic ulcers exceeding 60 minutes per day are not considered medically necessary, as prolonged

treatments beyond 60 minutes per day have not been proven to offer additional clinically significant

benefits.

Continued treatment is not covered if measurable signs of healing have not been demonstrated within any

30-day period of treatment. Measurable signs of improved healing include a decrease in wound size either

in surface area or volume, decrease in amount of exudates, and decrease in amount of necrotic tissue. If

electrical stimulation is being used, wounds must be evaluated at least monthly by the treating physician.

All other uses of electrical stimulation for the treatment of chronic ulcers will be denied as not medically

necessary and, therefore, not covered. This includes code G0282 that references all other stimulation not

described in code description G0281.

Electrical stimulation for wound healing is not covered in the home setting, as unsupervised use by

patients in the home has not been found to be medically necessary. Therefore, payment will not be made

for an electrical stimulation device used to treat wounds, code E0769.

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88

Electromagnetic therapy

Electromagnetic therapy for the treatment of wounds uses a pulsed magnetic field to induce current.

Electromagnetic therapy (G0329) is covered for the management of the following types of chronic ulcers

when it is used as adjunctive therapy after there are no measurable signs of healing for at least 30 days of

treatment with conventional wound treatments (Electromagnetic therapy will not be covered as an initial

treatment modality.):

Arterial ulcers;

Diabetic ulcers;

Pressure ulcers (Stage III or Stage IV);

Venous stasis ulcers.

Continued treatment is not covered if measurable signs of healing have not been demonstrated within any

30-day period of treatment. Measurable signs of improved healing include a decrease in wound size either

in surface area or volume, decrease in amount of exudates, and decrease in amount of necrotic tissue. If

electromagnetic therapy is being used, wounds must be evaluated at least monthly by the treating

physician.

All other uses of electromagnetic therapy for the treatment of chronic ulcers will be denied as not

medically necessary and, therefore, not covered. This includes code G0295 that references all other

therapy not described in code description G0329.

Electromagnetic therapy for wound healing is not covered in the home setting, as unsupervised use by

patients in the home has not been found to be medically necessary. Therefore, payment will not be made

for an electromagnetic wound treatment device used to treat wounds, code E0769.

Electrical stimulation or electromagnetic therapy services that do not meet the medical necessity criteria

on this policy will be considered not medically necessary.








denied.

PRN 8/2014

89

Note: It would not be appropriate for a patient to receive both electrical stimulation (G0281) and

electromagnetic therapy (G0329) for the treatment of these wounds.

Coverage for electrical stimulation and/or electromagnetic therapy is subject to any applicable physical

medicine limitation in the individual or group member's contract. A participating, preferred, or network

provider can bill the member for the denied services that exceed the member's benefit limitations.

Please refer to Medical Policy Y-16 for more information.

Subcutaneous implantable cardioverter-defibrillator coverage defined

As of Oct. 27, 2014, Highmark Blue Cross Blue Shield will consider subcutaneous implantable

cardioverter-defibrillator’s (S-ICD) experimental/investigational.

While current literature reports the S-ICD is promising for those individuals that cannot receive an

implantable cardioverter-defibrillator (ICD) or those individuals waiting for an ICD, the data is not

conclusive regarding long term efficacy. There are no clinical guidelines established as to what patient

population the S-ICD would benefit nor has there been any testing or clinical trials comparing the S-ICD

to the traditional ICD.


Coverage criteria revised for Ilizarov bone lengthening procedure

Effective Oct. 27, 2014, the coverage criteria for Ilizarov bone lengthening procedures changes to the

following:

Bone lengthening procedures (24420, 25391, 25393, 27466, 27715) may be considered medically

necessary when ANY ONE of the following are met:

correction of congenital or post-traumatic limb length discrepancies; or

angular deformities of the limb (arm, forearm, thigh or leg);

AND

ANY ONE of the following:

demonstrable non-union or mal-union of long bone with or without bone loss or infection;

where lengthening of an amputation stump is needed for proper fitting of a prosthesis;

PRN 8/2014

90

where leg lengthening is needed to equalize leg length discrepancy greater than 6 cm and for

correction of congenital or post-traumatic angular-rotational deformations of the long bones;

when used for bone defects with or without deformities.

Bone lengthening for conditions other than the above is not medically necessary and, therefore, is not

eligible for payment.

Note: Non-union/mal-union is defined as not having united within a minimum of three months of the

original trauma.








denied.

Use of a bone-lengthening device for the sole purpose of altering short stature is considered cosmetic. A

participating, preferred, or network provider can bill the member for the denied service.

Insertion of wires and subsequent osteotomy of the affected limb are performed in the hospital. Removal

of the device (20694) can be performed in an outpatient setting; thus, hospitalization to remove the bone

lengthening device is not medically necessary.


Criteria revised for diagnosis and treatment of obstructive sleep

apnea in adults

Highmark Blue Cross Blue Shield will revise the clinical criteria for the diagnosis and treatment of

obstructive sleep apnea in adults. Effective Oct. 27, 2014, the diagnosis and treatment of obstructive sleep

apnea in adults may be considered medically necessary for the following indications:

PRN 8/2014

91

Diagnosis of obstructive sleep apnea (OSA)

The diagnosis of OSA is based upon the presence or absence of related symptoms, as well as the

frequency of respiratory events during sleep (e.g., apneas, hypopneas, and respiratory effort related

arousals [RERAs]) as measured by polysomnography or out-of-center sleep testing (OCST). In adults, the

diagnosis of OSA is confirmed if EITHER of the following two conditions exists:

1. There are five (5) or more predominantly obstructive respiratory events (obstructive and mixed

apneas, hypopneas, or RERAs) per hour of sleep (for polysomnography) or recording time (for

out-of-center sleep test (OCST) in a patient with one or more of the following:

Sleepiness, non-restorative sleep, fatigue, or insomnia symptoms; or

Waking up with breath holding, gasping, or choking; or

Habitual snoring, breathing interruptions, or both noted by a bed partner or other

observer; or

Hypertension, mood disorder, cognitive dysfunction, coronary artery disease, stroke,

congestive heart failure, atrial fibrillation, or type 2 diabetes mellitus; or

2. There are fifteen (15) or more predominantly obstructive respiratory events (apneas, hypopneas,

or RERAs) per hour of sleep (for polysomnography) or recording time (for OCST), regardless of

the presence of associated symptoms or comorbidities.

Respiratory disturbance index (RDI):

Includes the total number of apneas, hypopneas, and respiratory effort related arousal (RERA)

during sleep, divided by the hours of sleep observed.

Apnea/hypopnea index (AHI):

Includes the total number of apneas and hypopneas recorded during sleep, divided by the hours of

sleep recorded.

An apnea/hypopnea index (AHI) >5 is considered abnormal an AHI of >30 is considered severe.

OSA severity classification

Mild for RDI or AHI 5 to 15 respiratory events per hour of sleep

Moderate for RDI or AHI 15 to 30 respiratory events per hour of sleep

Severe for RDI or AHI >30 respiratory events per hour of sleep

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92

Diagnostic testing

Out-of-center sleep testing (OCST)/portable monitoring (PM)

Unattended sleep studies

A single OCST/PM Unattended sleep study with a minimum of 4 recording channels (including oxygen

saturation, respiratory movement, airflow, and EKG or heart rate) may be considered medically necessary

when ANY ONE of the following criteria are met (1 or 2 or 3).

1. Adult patients who are at high risk for OSA/high pretest probability group. Patients with ALL

four (4) of the following habitual snoring; and

Observed apneas; and

Excessive daytime sleepiness; and

Symptoms are considered to be at high risk for OSA:

A body mass index greater than 35 kg/m2; or

If no bed partner is available to report snoring or observed apneas, other signs and symptoms

suggestive of OSA (e.g., age of the patient, male gender, thick neck, or craniofacial or upper

airway soft tissue abnormalities) may be considered.

2. Adults patients for positive airway pressure (CPAP or BiPAP) initiation and titration with sleep

related breathing disorders with EITHER of the following proven options for titration:

Auto-titrating continuous positive airway pressure (APAP) devices when used in the self-

adjusting mode for unattended treatment; or

In an unattended way to determine a fixed CPAP treatment pressure for patients with

moderate to severe OSA without significant comorbidities (e.g., including but not limited

to central sleep apnea, chronic pulmonary disease, congestive heart failure, etc.); or

3. Adult patients in order to monitor the response to non-CPAP treatments for OSA, including:

Evaluating response to oral appliance treatment; or

Evaluating for surgical treatment/upper airway surgery; or

Evaluation after significant weight loss.

o after substantial weight loss (i.e., 10% or more of body weight), a follow-up PSG

may be considered medically necessary to re-evaluate the diagnosis of OSA and

need for continued CPAP, e.g., if there is a significant change in weight or

change in symptoms suggesting that CPAP should be re-titrated or possibly

discontinued. The follow-up PSG is routinely indicated to ascertain whether PAP

therapy is still needed or whether adjustments in PAP level are necessary.

PRN 8/2014

93

Note: This statement does not imply that attended studies are needed routinely following unattended

studies. This statement means a re-evaluation based on a substantial change in symptoms or in the clinical

situation.

OCST/PM Unattended sleep studies are considered experimental/investigational in adult patients who do

not meet any of the above criteria as they would be considered at low to moderate risk for OSA.

Facility/laboratory attended sleep studies

Attended polysomnography performed in a sleep laboratory with a minimum of 7 recording channels

(including electroencephalogram (EEG), electrooculogram (EOG), chin electromyogram (EMG),

electrocardiogram (ECG) or heart rate, airflow, respiratory effort, oxygen saturation) may be considered

medically necessary as a diagnostic test in patients with ANY ONE of the following (1 or 2 or 3):

1. Previous home study was technically inadequate; or

2. Observed apneas during sleep AND a combination of AT LEAST two (2) of the following AND

a comorbid medical condition or comorbid sleep disorder:

Excessive daytime sleepiness evidenced by an Epworth Sleepiness Scale greater than 10,

inappropriate daytime napping (e.g., during driving, conversation, or eating) or sleepiness

that interferes with daily activities and is not explained by other conditions; or

Habitual snoring, or gasping/choking episodes associated with awakenings; or

Unexplained hypertension; or

Obesity, defined as a body mass index greater than 35kg/m2; or

Craniofacial or upper airway soft tissue abnormalities, including adenotonsillar

hypertrophy or neuromuscular disease (e.g., Parkinson’s disease, spina bifida, myotonic

dystrophy, amyotrophic lateral sclerosis (ALS));

AND

Comorbid medical conditions:

Atrial fibrillation; or

Chronic pulmonary disease; or

Congestive heart failure (if they remain symptomatic despite optimal medical

management of congestive heart failure); or

Coronary artery disease; or

Significant tachycardia or bradycardic arrhythmias; or

Stroke, transient ischemic attack; or

Type II diabetes; or

PRN 8/2014

94

Comorbid sleep disorders:

Central sleep apnea; or

Circadian rhythm disorders; or

Insomnia (associated with psychiatric disorders or transient or chronic insomnia); or

Parasomnias;

o non-rapid eye movement (NREM) related parasomnias are disorders of arousal,

including confusional arousals, sleepwalking, sleep terrors, and sleep related

eating disorder; or

o rapid eye movement (REM) related parasomnias involve the intrusion of the

features of REM sleep into wakefulness (e.g., sleep paralysis), exaggeration of

the features of REM sleep (e.g., nightmare disorder), or failure to manifest one of

the core features of REM sleep (e.g., lack of atonia as observed in REM sleep

behavior disorder); or

Narcolepsy; or

Obesity hypoventilation syndrome; or

Periodic limb movements in sleep; or

Restless leg syndrome; or

3. Patients requiring positive airway pressure (CPAP or BiPAP) initiation and titration in patients

with sleep related breathing disorders with the following proven option for titration:

Evaluation for the presence of OSA in patients before they undergo upper airway surgery

for snoring or OSA; or

Assessment of treatment results to evaluate response to oral appliance treatment; or

Surgical treatment for OSA; or

Resolution of OSA after significant weight loss.

o after substantial weight loss (i.e., 10% or more of body weight), a follow-up PSG

may be considered medically necessary to re-evaluate the diagnosis of OSA and

need for continued CPAP, e.g., if there is a significant change in weight or

change in symptoms suggesting that CPAP should be re-titrated or possibly

discontinued. The follow-up PSG is routinely indicated to ascertain whether PAP

therapy is still needed or whether adjustments in PAP level are necessary.



situation.

PRN 8/2014

95

For CPAP initiation and titration, a split-night study (initial PSG followed by CPAP titration during PSG

on the same night) is an alternative to one full night of PSG followed by a second night of titration when

ALL three (3) of the following criteria are met:

1. An apnea hypopnea index (AHI) of at least 40 events per hour of sleep is documented during a

minimum of 2 hours of sleep. Alternatively, an AHI of 20 to 39 events per hour of sleep is

documented during a minimum of 2 hours of sleep and there is strong supportive evidence of

OSA (e.g., repetitive long obstructions with major desaturations), and

2. Positive airway pressure titration is conducted for more than 3 hours, since obstructive events can

worsen as the night progresses, and

3. Elimination or near elimination of obstructive events with positive airway pressure is documented

by PSG during rapid eye movement (REM) and non-REM (NREM) sleep. This should include

REM sleep in the supine position, when apneas are most likely to occur.

A second full night PSG should be performed for titration of positive airway pressure if the second and

third criteria are not met.

Notes:

A split-night study, in which severe OSA is documented during the first portion of the study

using polysomnography, followed by CPAP during the second portion of the study, can eliminate

the need for a second study to titrate CPAP.

Respiratory disturbance index may be used in place of apnea/hypopnea index (AHI) in

unattended sleep studies.

Repeat sleep studies

Repeat OCST/PM Unattended Sleep Study

Repeated OCST/PM Unattended sleep studies with a minimum of 4 recording channels (including oxygen

saturation, respiratory movement, airflow, and EKG/heart rate) may be considered medically necessary in

adult patients for EITHER ONE of the following circumstances:

1. To assess efficacy of surgery or oral appliances/devices; or

2. To re-evaluate the diagnosis of OSA and need for continued CPAP (e.g., if there is a significant

change in weight or change in symptoms suggesting that CPAP should be re-titrated or possibly

discontinued).

Multiple consecutive nights of attended or unattended sleep studies that do not meet the above criteria for

repeat studies are considered not medically necessary.

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96

Repeat facility/laboratory attended sleep studies

A repeat supervised polysomnography performed in a sleep laboratory may be considered medically

necessary under the following circumstances:

1. To initiate and titrate continuous positive airway pressure (CPAP) in adult patients with clinically

significant OSA defined as those patients who have:

An apnea/hypopnea index (AHI) of at least 15 per hour, or

An AHI of at least 5 per hour in a patient with excessive daytime sleepiness or

unexplained hypertension.

2. Failure of resolution of symptoms or recurrence of symptoms during treatment, or

3. To assess efficacy of surgery or oral appliances/devices, or

4. To re-evaluate the diagnosis of OSA and need for continued CPAP, e.g., if there is a significant


discontinued.

Note: This statement does not imply that supervised studies are needed routinely following unattended

studies. This statement means a reevaluation based on a substantial change in symptoms or in the clinical

situation.

Multiple sleep latency test (MSLT)

Multiple sleep latency testing is considered not medically necessary in the diagnosis of OSA except to

exclude or confirm narcolepsy in the diagnostic workup of OSA syndrome.

The MSLT are not routinely indicated in the evaluation and diagnosis of OSA or in assessment of change

following treatment with CPAP. The MSLT may be indicated as part of the evaluation of patients with

suspected narcolepsy to confirm the diagnosis (often characterized by cataplexy, sleep paralysis, and

hypnagogic/hypnopompic hallucinations) or to differentiate between suspected idiopathic hypersomnia

and narcolepsy. Narcolepsy and OSA can co-occur. Since it is not possible to differentiate the excessive

sleepiness caused by OSA and narcolepsy, the OSA should be treated before confirming a diagnosis of

narcolepsy with the MSLT.

Actigraphy

Actigraphy is considered experimental/investigational when used as the sole technique to record and

analyze body movement, including but not limited to its use to evaluate sleep disorders. This does not

include the use of actigraphy as a component of portable sleep monitoring. When used as a component of

portable sleep monitoring, actigraphy should not be separately reported. Evidence indicates that

actigraphy does not provide a reliable measure of sleep efficiency in clinical populations. Evidence to

PRN 8/2014

97

date does not indicate that this technology is as beneficial as the established alternatives. A participating,

preferred, or network provider can bill the member for the denied service.

See Medical Policy E-25 for guidelines on the guidelines on the home pulse oximetry device.

Medical treatment

Snoring

Socially disruptive snoring is not a disease, illness, or injury. Therefore, treatment solely for the

correction of socially disruptive snoring is considered not medically.

Obstructive Sleep Apnea

Behavior Modification:

Behavioral treatment options include weight loss, ideally to a body mass index (BMI) of 25 kg/m2 or less;

exercise; positional therapy; and avoidance of alcohol and sedatives before bedtime. Regardless of

behavioral approach, general OSA outcomes should be assessed after initiation of therapy in all patients.

Successful dietary weight loss may improve the AHI in obese patients with OSA. After substantial weight

loss (i.e., 10% or more of body weight), a follow-up PSG may be considered medically necessary:

To re-evaluate the diagnosis of OSA and need for continued CPAP, e.g., if there is a significant


discontinued.

The follow-up PSG is routinely indicated to ascertain whether PAP therapy is still needed or whether

adjustments in PAP level are necessary.



situation.

Drug therapy for OSA is of limited clinical value.

Continuous Positive Airway Pressure (CPAP)

See Medical Policy E-20 for guidelines on devices used for the treatment of obstructive sleep apnea in

adults.

Intra-oral appliances

See Medical Policy E-20 for guidelines on devices used for the treatment of obstructive sleep apnea in

adults.

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98

Surgical treatment

Uvulopalatopharyngoplasty (UPPP) may be considered medically necessary for the treatment of clinically

significant obstructive sleep apnea syndrome (OSA) in appropriately selected adult patients who have not

responded to or do not tolerate nasal continuous positive airway pressure (CPAP).

Note: A tonsillectomy is considered an integral component of UPPP and is not separately reimbursed.

Hyoid suspension, surgical modification of the tongue, and/or maxillofacial surgery, including

mandibular-maxillary advancement (MMA) may be considered medically necessary in appropriately

selected adult patients with clinically significant OSA and objective documentation of hypopharyngeal

obstruction who have not responded to or do not tolerate CPAP or failed use of an oral appliance (OA).

Surgical treatments, including but not limited to the following, may be considered medically necessary for

the treatment of OSA:

Tracheostomy.

The following surgical treatments may be considered medically necessary for the adjunctive treatment of

OSA:

Adenoidectomy, or

Tonsillectomy, or

Adenotonsillectomy.

Clinically significant OSA is defined as those patients who have:

Apnea/hypopnea index (AHI) or respiratory disturbance index (RDI) greater than or equal to 15

events per hour, or

AHI or RDI greater than or equal to 5 events and less than or equal to 14 events per hour with

documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or

insomnia, or documented hypertension, ischemic heart disease, or history of stroke.

Surgical treatment of OSA that does not meet the criteria above is considered not medically necessary.

The following minimally-invasive surgical procedures are considered experimental/investigational for the

treatment of OSA:

Atrial overdrive pacing

Laser-assisted palatoplasty (LAUP) or radiofrequency volumetric tissue reduction of the palatal

tissues

Laser-assisted tonsillectomy or laser ablation of the tonsils (LAT)

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Palatal stiffening procedures including, but not limited to, cautery-assisted palatal stiffening

operation, injection of a sclerosing agent (CAPSO), and the implantation of palatal implants

Partial glossectomies

Polypectomy

Radiofrequency volumetric tissue reduction of the tongue, with or without radiofrequency

reduction of the palatal tissues (e.g., Somnoplasty)

Septoplasty

Tongue base suspension (e.g., Repose™ System )

Turbinectomy

Uvulectomy

All other minimally-invasive surgical procedures not described above.

Because of the likelihood of adverse effects, surgery should be limited to patients who are unable to

tolerate CPAP. Minimally invasive surgical procedures have limited efficacy in patients with mild to

moderate OSA and have not been shown to improve AHI or excessive daytime sleepiness in adult patients

with moderate to severe OSA. These are considered experimental/investigational.

Note: All interventions, including but not limited to LAUP, laser-assisted tonsillectomy or laser ablation

of the tonsils (LAT), radiofrequency volumetric tissue reduction of the palate, palatal stiffening

procedures and tongue based suspension procedures are considered not medically necessary for the

treatment of snoring in the absence of documented OSA; snoring alone is not considered a medical

condition.








denied.

See Medical Policy Z-64 for guidelines on diagnosis and treatment of obstructive sleep apnea in children.

Please refer to Medical Policy Z-8 for more information.

PRN 8/2014

100

New criteria for percutaneous ventricular assist devices

Effective Oct. 27, 2014, there is added criteria for percutaneous ventricular assist devices.

Percutaneous ventricular assist devices (33990) are intended for partial circulatory, short-term support (up

to 6 hours for the Impella 2.5 and up to 14 hours for the TandemHeart). The Impella® 2.5 Circulatory

Support System or the TandemHeart (CardiacAssist) may be considered medically necessary for short-

term stabilization of patients with the following indications:

Cardiogenic shock that is refractory to medications and intra-aortic balloon pump (IABP); or

Cardiogenic shock, as an alternative to IABP; or

High-risk patients undergoing invasive cardiac/electrophysiological procedures who need

circulatory support; or

Ongoing acute MI in patients at risk for hemodynamic compromise from un-vascularized severe

Coronary Artery Disease (CAD).

Percutaneous ventricular assist devices are considered experimental/investigational for all other

indications because of insufficient evidence in the peer-reviewed literature. A participating, preferred, or

network provider can bill the member for the denied service.

The exclusion criteria for the Impella 2.5 and the TandemHeart cardiac assist device are as follows:

Mechanical aortic valve or heart constrictive device;

Aortic valve stenosis/calcification (graded as ≥ +2 equivalent to an orifice area of 1.5 cm2 or

less);

Moderate to severe aortic insufficiency (echocardiographic assessment of aortic insufficiency

graded as ≥ +2);

Severe peripheral arterial obstructive disease that would preclude device placement.

Percutaneous ventricular assist devices are contraindicated for the above exclusion criteria.

Note: These devices are unique in that they allow for percutaneous access through the femoral vein,

permitting rapid deployment.

For prolonged extracorporeal percutaneous trans-septal ventricular assist device, use not otherwise

classified code 33999.

The use of non-FDA approved or cleared ventricular assist device (VAD) is considered

experimental/investigational and therefore, non-covered. A participating, preferred, or network provider

can bill the member for the non-covered service.

PRN 8/2014

101


Hepatorenal syndrome added to indications for liver transplantation—

also substance abuse criteria changed

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will add indications for hepatorenal syndrome

for liver transplantation. Hepatorenal syndrome may be considered medically necessary for the following:

Glomerular filtration rate (GFR) < 40ml/min, and

All other causes for renal failure have been excluded.

Also, the following criteria must be met with regards to substance abuse (alcohol and/or drug abuse) for

liver transplant to be considered:

Abstinence of substance abuse for a minimum of six (6) months, and

Active participation in a substance rehabilitation program as well as successful completion of the

rehabilitation program, and

Consistent negative results of random blood or urine drug testing.


B-RAF DNA mutational testing (Serine/threonine-protein kinase B-

RAF) considered experimental/investigational

Effective Oct. 27, 2014, Highmark Blue Cross Blue Shield will consider B-RAF DNA mutational testing

(serine/threonine-protein kinase b-RAF) experimental/investigational for testing papillary thyroid cancer.

The safety and/or effectiveness of this service cannot be established by review of the available published

peer-reviewed literature.

Please refer to Medical Policy Z-24 Miscellaneous Services, for more information.

Ozurdex™ considered medically necessary for diabetic macular

edema

Effective Sept. 1, 2014, Highmark Blue Cross Blue Shield may consider Ozurdex™ medically necessary

for the treatment of diabetic macular edema in patients who are pseudophakic or are phakic and scheduled

for cataract surgery.

PRN 8/2014

102

The use of Ozurdex for any other indication is considered experimental/investigational, and therefore,

would not be covered. A participating, preferred, or network provider can bill the member for the denied

service.


Clinical criteria established for denosumab (Prolia®, Xgeva®)

Highmark Blue Cross Blue Shield’s Medicare Advantage products, Freedom Blue PPO and

Security Blue HMO, have established new clinical criteria for the use granulocyte colony-

stimulating factors. This new Medicare Advantage Medical Policy will become effective Oct. 27,

2014.

Denosumab (Prolia®, a RANK ligand (RANKL) inhibitor, may be considered medically necessary for

the following indications:

To increase bone mass in men at high risk for fracture (T score <-1.0 and multiple risk factors for

fracture OR a previous osteoporotic fracture) who are receiving androgen deprivation therapy for

non-metastatic prostate cancer.

To increase bone mass in women at high risk for fracture (T score <-1.0 and multiple risk factors

for fracture OR a previous osteoporotic fracture) who are receiving adjuvant aromatase therapy

for breast cancer.

To treat osteoporosis and to prevent fractures in men and postmenopausal women who have a

documented bone mineral density (BMD) T-score <-2.5 establishing the diagnosis of

osteoporosis; and

o the member has had an adequate trial and failure of at least one bisphosphonate. Trial and

failure will be defined as a decrease in BMD despite a trial and failure of bisphosphonate

therapy; or

o the member has a contraindication to at least one bisphosphonate or a significant reason




minutes.

Medicare Advantage Policy

MA

PRN 8/2014

103

To prevent fractures in men and postmenopausal women with a low bone mass (T-score between

-1 and -2.5) AND history of a previous osteoporotic fracture; and



therapy; or


why a bisphosphonate may not be used (e.g., severe GERD). Contraindications to



minutes.

To prevent fractures in men and postmenopausal women who are found to have a 10-year risk of

major osteoporotic fracture greater than or equal to 20% or a risk of hip fracture greater than or

equal to 3% using the FRAX calculator; and



therapy; or





minutes.

Denosumab (Xgeva®), a RANK ligand (RANKL) inhibitor, may be considered medically necessary for

either of the following indications:

For the prevention of skeletal-related events in adults (greater than or equal to 18 years of age)

with bone metastases from ANY of the following solid tumor types:

o invasive breast cancer in patients with expected survival of ≥3 months and adequate renal

function;

o castration-recurrent prostate cancer with documented creatinine clearance greater than 30

mL/min;

o non-small cell lung cancer (NSCLC);

o kidney cancer;

o thyroid cancer (follicular, Hürthle cell, medullary, or papillary carcinoma);

OR

PRN 8/2014

104

For the treatment of localized or metastatic giant cell tumor of the bone (GCTB) that is

unresectable or where surgical resection is likely to result in severe morbidity when either of the

following criteria below are met:

o adults (greater than or equal to 18 years of age); or

o skeletally mature adolescents (defined by at least 1 mature long bone [for example;

closed epiphyseal growth plate of the humerus]).

Limitations of coverage

Denosumab is contraindicated in patients with hypocalcemia. Pre-existing hypocalcemia must be

corrected prior to initiating denosumab.

Patients receiving Prolia should not receive XGEVA (denosumab), as both Prolia and XGEVA

contain the same active ingredient, denosumab.

Warning: Women should be advised not to become pregnant when taking Xgeva. If this drug is

used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient

should be apprised of the potential hazard to the fetus.

Denosumab (Xgeva) is not approved for patients with multiple myeloma or other cancer of the

blood.

The use of denosumab (Prolia) for any other indication not listed above is considered

experimental/investigational, and therefore, not medically necessary.

Denosumab (Xgeva) is considered experimental/investigational and therefore, not medically necessary

when all of the criteria specified above are not met, or for the treatment of all other indications.

Denosumab (Xgeva) is considered experimental/investigational and therefore, not medically necessary for

the prevention of skeletal related events in individuals with multiple myeloma.


It is recommended that the member take calcium and vitamin D supplements on a daily basis to treat or

prevent hypocalcemia.

Services denied as not reasonable and medically necessary, under section 1862(a)(1) of the Social

Security Act, are subject to the Limitation of Liability provision. A contracted provider must inform the

enrollee to request an organization determination from the plan or the provider can request the

organization determination on the enrollee’s behalf. Failure to provide a compliant denial to the enrollee

means that the enrollee is not liable for services provided by a contracted provider or upon referral from a

contracted provider.

PRN 8/2014

105

Please refer to Medicare Advantage Medical Policy I-20 for more information.

Clinical criteria established for docetaxel (Taxotere®)


Security Blue HMO, have established new clinical criteria for the use of docetaxel (Taxotere®).

Medicare Advantage Medical Policy I-25 will become effective Oct. 27, 2014.

The use of docetaxel may be considered medically necessary when used in the treatment of the following

condition(s):

Bladder Cancer

Primary treatment as a single agent or in combination therapy for patients with clinical node


status.


o A first-line alternative therapy, single agent, or in combination therapy for patients who


o used as a second-line therapy, single agent, if not used as a first line therapy.

As radiosensitizing chemotherapy given concurrently with radiation for palliation of metastases

or for pelvic recurrence after cystectomy.


Used as a single-agent therapy for:

o primary treatment for clinical stage T3-4, cN1-2 disease or cN1-2 palpable inguinal

lymph nodes, or










MA

PRN 8/2014

106








Used with growth factor support in combination with gemcitabine with or without vincristine or:



o as second-line therapy for metastatic disease.


As a second-line therapy in combination with gemcitabine with growth factor support.


As a preoperative systemic therapy for patients with stage IIA, IIB, or T3, N1, M0 disease who

desire breast preservation and fulfill criteria for breast-conserving surgery except for tumor size

or for locally advanced disease (stage IIIA, IIIB, or IIIC):


o following AC (doxorubicin and cyclophosphamide) regimen, or

o following FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen, or

o in TAC (docetaxel, doxorubicin, and cyclophosphamide) regimen, or

o in TCH (docetaxel, carboplatin, and trastuzumab) (preferred regimen) or in combination

with trastuzumab following AC regimen for human epidermal growth factor receptor 2-

positive tumors.

In TCH regimen with pertuzumab for HER2-positive, ≥T2 or ≥N1 early stage breast cancer.

In combination with trastuzumab and pertuzumab following AC regimen or prior to or following

FEC/CEF regimen for HER2-positive, ≥T2 or ≥N1 early stage breast cancer.

As an adjuvant systemic therapy for stage I, IIA, IIB, or T3, N1, M0 disease or for locally

advanced disease (stage IIIA, IIIB, or IIIC):


o following AC regimen, or

o following FEC/CEF regimen, or

o in TAC regimen, or

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107

o in TCH (preferred regimen) or in combination with trastuzumab following AC regimen

for human epidermal growth factor receptor 2 (HER2)-positive tumors, or

o in TCH regimen in combination with pertuzumab (preferred regimen) for HER2-positive,

≥T2 or ≥N1 early stage breast cancer if a pertuzumab-containing regimen was not used as

neoadjuvant therapy, or

o in combination with trastuzumab and pertuzumab following AC regimen or prior to or

following FEC/CEF regimen for HER2-positive, ≥T2 or ≥N1 early stage breast cancer if

a pertuzumab-containing regimen was not used as neoadjuvant therapy.

As a single agent or in combination with capecitabine for recurrent or metastatic disease that is:

o hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative,






Used in combination with trastuzumab for recurrent or metastatic disease as first-line therapy for

human epidermal growth factor receptor 2 (HER2)-positive disease or as therapy for trastuzumab-

exposed HER2-positive disease that is:






or with symptomatic visceral disease:

o as a preferred first-line therapy in combination with pertuzumab and trastuzumab, or


therapy beyond first-line therapy for patients previously treated with chemotherapy and


Cervical Cancer

As a second-line therapy, single agent for:




Used in medically fit patients in combination with cisplatin as a:

PRN 8/2014

108

o definitive chemoradiation for patients who decline surgery for adenocarcinoma and

recommended for cervical esophagus squamous cell carcinoma for T1b, N+ or T2-4a,

N0-N+, or

o as a definitive chemoradiation for T4b.

As a definitive concurrent chemoradiation for locoregional disease in combination with cisplatin:

o for medically unfit patients with T1b, N0 tumors with poor prognostic features, or

o as primary treatment for T1b, N+, T2-T4a, or unresectable T4b disease for patients who

are unfit for or do not elect surgery.

As concurrent chemoradiation in combination with cisplatin for locoregional recurrence for

patients who have had surgery but no prior chemoradiation.

As palliative therapy for patients with Karnofsky performance score ≥60% or ECOG performance

score ≤2 as a single agent (preferred for second line), in combination with cisplatin (first line) or

irinotecan, or as a component of preferred first-line DCF (docetaxel, cisplatin, and fluorouracil)

regimen or its modifications (docetaxel, cisplatin, and fluorouracil; docetaxel, oxaliplatin, and

fluorouracil; or docetaxel, carboplatin, and fluorouracil) for:






Gastric Cancer

As a primary treatment with docetaxel-based chemoradiation for:

o unresectable locoregional disease in medically fit patients, or


As a palliative therapy for patients with Karnofsky performance score ≥60% or ECOG

performance score ≤2 as a single agent (preferred for second line), in combination with cisplatin

(first line) or irinotecan, or as a component of preferred first-line DCF (docetaxel, cisplatin, and

fluorouracil) regimen or its modifications (docetaxel, cisplatin, and fluorouracil; docetaxel,

oxaliplatin, and fluorouracil; or docetaxel, carboplatin, and fluorouracil) for:

o locoregional disease in medically unfit patients, or


o medically inoperable or unresectable residual disease following primary treatment, or

o unresectable locally advanced, locally recurrent, or metastatic disease.

PRN 8/2014

109


For non-nasopharyngeal cancer in combination with cisplatin and fluorouracil in patients with

performance status 0-1 for:


unfit for surgery, or


therapy.

Therapy as a:



recurrence and no prior radiation therapy (RT), or for patients who are unfit for surgery,

or

o single agent in PS 0-2 patients or in combination (PS 0-1) with cisplatin with (non-

nasopharyngeal cancer) or without cetuximab or with carboplatin for unresectable


distant metastases.






o T1, N+, or





o T1, N+, or




As induction chemotherapy in combination with cisplatin with or without fluorouracil for:



PRN 8/2014

110










surgery, or


Head and Neck Cancer – Occult Primary

Initial definitive treatment in combination with cisplatin and fluorouracil.


When used in combination with cisplatin as:






chemotherapy.

As an adjuvant chemotherapy in combination with cisplatin:

o following definitive radiation therapy in medically inoperable high-risk stage IB

(peripheral T2a, N0), stage I (central T1ab- 2a, N0), stage II (T1ab- 2ab, N1; T2b, N0), or








N0-1), or

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111



o for margin-negative or margin positive, R1 T1-3 (including T3 with multiple nodules in



o separate pulmonary nodule(s) in the same lobe (T3) or ipsilateral nonprimary lobe (T4),

N0-1, or



Therapy for recurrence or metastasis:

o as a first line therapy in combination with cisplatin, carboplatin, or gemcitabine in

performance status (PS) 0-2 or elderly patients, or

o as a first line therapy, single agent, for PS 2 or elderly patients, or

o as a second line therapy, single agent, for progression in patients with negative or

unknown EGFR mutation status if not already given, or

o as a third line therapy, single agent, for progressive disease in patients with PS 0-2 if not

already given.

As a first-line therapy in cisplatin- or carboplatin-based regimens in combination with

bevacizumab for recurrence or metastasis for patients with performance status 0-1, tumors of

nonsquamous cell histology, and no history of recent hemoptysis.

As a single-agent switch maintenance for recurrence or metastasis of squamous cell carcinoma

for patients with performance status 0-2 who achieve tumor response or stable disease following

first-line chemotherapy.

Occult Primary

When used as chemoradiation in combination with carboplatin or gemcitabine in symptomatic


disease for localized disease with axillary or inguinal nodal involvement.

When used in combination with carboplatin or gemcitabine in symptomatic patients with


o lung nodules or breast marker-negative pleural effusion, or





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112

When used in combination with cisplatin or carboplatin or with cisplatin and fluorouracil in





metastases.


As a neoadjuvant chemotherapy in combination with carboplatin for bulky stage III-IV disease in

poor surgical candidates.












levels in patients who have received no prior chemotherapy.

As a preferred single-agent therapy, if platinum-resistant, for persistent disease or recurrence.

As a preferred therapy, if platinum-sensitive, in combination with carboplatin for persistent

disease or recurrence.


Used as a single agent or in combination with carboplatin for recurrent or residual disease.


As a single agent for clinical relapse in patients with stage II-IV disease.


Used for patients with locally advanced unresectable or metastatic disease and good performance

status as a component of GTX (gemcitabine, docetaxel, and capecitabine) regimen.

PRN 8/2014

113

Penile Cancer

As a single-agent therapy for second-line treatment of metastatic disease.

Prostate Cancer

Used in combination with prednisone for:

o castration-recurrent metastatic disease, or

o treatment of distant metastases with small cell features.


As subsequent chemotherapy for patients with performance status 0-2 as single agent for:

o relapse within 6 months following complete or partial response or stable disease with

initial treatment, or



Used for angiosarcoma:


o in combination with gemcitabine.

Soft Tissue Sarcoma – Retroperitoneal/Intra-abdominal


o preoperative chemotherapy for resectable disease, or

o primary therapy for attempted downstaging of unresectable, recurrent, or metastatic

disease, or

o palliative therapy for unresectable or progressive disease.


As a therapy in combination with gemcitabine for pleomorphic rhabdomyosarcoma.

Soft Tissue Sarcoma of the Extremity/Superficial Trunk


o preoperative chemotherapy or chemoradiation for resectable stage IIB-III tumors

(primary tumors or local recurrence) with acceptable functional outcomes, or

o primary treatment as chemotherapy or chemoradiation for stage II-III resectable disease

with adverse functional outcomes or unresectable disease (primary tumors or local

recurrence), or

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114

o adjuvant chemotherapy for resectable stage IIB-III disease (primary tumors or local

recurrence) with acceptable functional outcomes or for stage II-III resectable disease with

adverse functional outcomes, or

o treatment before or after metastasectomy with or without radiation therapy for single-

organ confined, limited tumor bulk synchronous stage IV or recurrent disease that is

amenable to local therapy or for recurrent isolated regional disease or isolated regional

lymph nodes, or

o chemotherapy with or without radiation following regional node dissection, or

o palliative chemotherapy for synchronous stage IV or recurrent disease with disseminated

metastases.


As a primary treatment (in patients in whom paclitaxel is contraindicated), single agent, or in

combination with carboplatin:





For surgically staged patients as a single agent or in combination with carboplatin as adjuvant

treatment (in patients in whom paclitaxel is contraindicated):


with stage IB disease with histologic grade 3 tumors and adverse risk factors, or



o with or without sequential tumor-directed RT for stage IIIA, IIIB, and IIIC disease, or

o with or without sequential RT for stage IV disease.

Single agent or in combination with carboplatin as adjuvant treatment with sequential RT and

vaginal brachytherapy with or without para-aortic RT for incompletely surgically staged patients

with histologic grade 3 tumors.

As a single agent or in combination with carboplatin (in patients in whom paclitaxel is

contraindicated):



or large volume metastases, or

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115

o with sequential tumor-directed RT with or without brachytherapy for local recurrence in

patients with disease confined to the vagina or in pelvic, para-aortic, or common iliac

lymph nodes, or




of recurrence.

As an adjuvant therapy (in patients in whom paclitaxel is contraindicated), single agent, or in

combination with carboplatin and with or without:




Uterine Neoplasm – Uterine Sarcoma

Used in combination with gemcitabine (preferred for leiomyosarcoma):

o for medically inoperable disease limited to the uterus, or

o following total hysterectomy with or without bilateral salpingo-oophorectomy (TH±BSO)

for stage I-III disease, or

o following TH±BSO for stage IV disease, or

o for local recurrence confined to the vagina, or

o for extrapelvic recurrence with no prior radiation therapy, or

o for isolated metastases, postoperative chemotherapy for resectable isolated metastases, or

o for disseminated metastases.









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116

Criteria established for Irinotecan (Camptosar®)


Security Blue HMO, have established new clinical criteria for the use of irinotecan

(Camptosar®). This new Medicare Advantage Medical Policy will become effective Sept. 1,

2014.

Camptosar may be considered medically necessary for the following indications when specific criteria are

met:

Colon Cancer (Adenocarcinoma)

Bone Cancer - Ewing's Sarcoma Family of Tumors

Central Nervous System Cancers - Anaplastic Gliomas and Glioblastomas

Cervical Cancer (Squamous cell carcinoma; Adenocarcinoma)

Esophageal and Esophagogastric Junction Cancers (Squamous cell carcinoma; Adenocarcinoma)

Gastric Cancer (Adenocarcinoma)

Non-Small Cell Lung Cancer (NSCLC) (Adenocarcinoma (with mixed subtypes); Squamous cell

carcinoma; Large cell carcinoma)



Rectal Cancer (Adenocarcinoma)

Small Cell Lung Cancer (SCLC) (Small cell carcinoma)


The use of irinotecan (Camptosar) for all other indications is considered experimental/investigational, and

therefore, non-covered. Peer-reviewed literature does not support the use of irinotecan (Camptosar) for

any indications other than those listed on this medical policy.

For further information, refer to Medicare Advantage Medical Policy I-24, Irinotecan (Camptosar®).

Clinical criteria established for carboplatin (Paraplatin®)


SecurityBlue, will establish new clinical criteria for the use of carboplatin (Paraplatin®). This

new Medicare Advantage Medical Policy will become effective Oct. 27, 2014.

The use of carboplatin Paraplatin) may be considered medically necessary when used in the treatment of

the following condition(s):

MA

MA

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117

Bladder Cancer



As a second-line therapy single agent if not used as a first line therapy.

Bladder Cancer-Primary Carcinoma of the Urethra



As a second line therapy single agent if not used as first line therapy.










When used with a growth factor support in combination with etoposide and ifosfamide with or

without vincristine or:



o as a second line therapy for metastatic disease.


As a second line therapy in combination with etoposide and ifosfamide with growth factor

support.


As a preferred preoperative systemic therapy for patients with human epidermal growth factor

receptor 2 (HER2), or

Positive stage IIA, IIB, or T3, N1, M0 disease who desire breast preservation , or

PRN 8/2014

118

Fulfill criteria for breast-conserving surgery except for tumor size or for locally advanced disease

(stage IIA, IIB, or IIC) in TCH (docetaxel, carboplatin, and trastuzumab) regimen alone or with

TCH regimen with pertuzumab for >=T2 or >=N1 early stage breast cancer.

As a single agent or in combination with gemcitabine for recurrent or metastatic disease that is:



o HER2-negative and wither hormone receptor –negative or hormone receptor-positive and




Used in combination with paclitaxel and trastuzumab as a first line therapy for recurrent or

metastatic human epidermal growth factor receptor 2 (HER2), positive disease or as therapy for

trastuzumab, exposed HER2-positive disease that is:


o either hormone receptor-negative or hormone receptor-positive and endocrine therapy

refractory with symptomatic visceral disease, or



Central Nervous System Cancers – Adult Intracranial and Spinal Ependymoma (Excluding

Subependymoma)

As a single agent treatment or as a component of platinum based regimens for disease

progression.

Central Nervous System Cancers – Adult Low-Grade Infiltrative Supratentorial

Astrocytoma/Oligodendroglioma (excluding pilocytic astrocytoma)

As a treatment component of platinum based regimens for recurrent or progressive disease.

Central Nervous System Cancers – Adult Medulloblastoma and Supratentorial Primitive Necroectodermal

Tumors (PNET)

As a recurrence/salvage therapy in combination with etoposide and cyclophosphamide for disease

progression in patients who have not received prior chemotherapy.

Central Nervous System Cancers – Anaplastic Gliomas

In the treatment of recurrent disease or salvage therapy in platinum based chemotherapy regimens

or in combination with bevacizumab.

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119

Central Nervous System Cancers – Glioblastoma

In the treatment of recurrent disease, or salvage therapy in platinum based chemotherapy

regimens, or in combination with bevacizumab.

Cervical Cancer

As a first line therapy when used as a single agent or in combination with paclitaxel for:




For the use of locoregional disease in medically fit patients and in combination with paclitaxed as

a preferred regimen and:

o definitive chemoradiation for patients who decline surgery and are recommended for

cervical esophagus squamous cell carcinoma for T1b, N+ or T2-4a, N0-N+ , or

o definitive chemoradiation for T4a.

For medically unfit patients with T1b, N0 tumors with poor prognostic features, or

As a primary treatment for T1b, N+, T2-T4a, or unresectable T4b disease for patients who are

unfit for or do not elect surgery.

As a concurrent chemoradiation in combination with paclitaxel as a preferred regimen for

locoregional recurrence in patients who have had surgery but no prior chemoradiation.

As palliative therapy for patients with Karnofshy performance score >=60%, or ECOG

performance score <=2 in combination with paclitaxed, or as a component of preferred modified

DCF (docetaxel, carboplatin and fluorouracil) regimen as a first line therapy for the following:






Gastric Cancer

As a preoperative chemoradiation for resectable locoregional disease. (T2 or higher by clinical

staging any N) in medical fit patients.


As a primary concurrent chemoradiation for non-nasopharyngeal cancer for:

o patients with performance status (PS) 0-2 who have newly diagnosed T4b and any N,

unresectable nodal disease with no metastases, or who are unfit for surgery, or

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120

o locoregional recurrence is PS 0-2 patients who have not received prior radiation therapy.

For sequential chemoradiation following induction chemotherapy in performance status 0-1

patients with non-nasopharyngeal disease for :

o newly diagnosed T4b and any N, or unresectable nodal disease with no metastases, or

patients unfit for surgery, or


therapy.

As a single agent for patients with performance status (PS) 3, with newly diagnosed T4b and any

N, unresectable nodal disease with no metastases, or with unresectable locoregional recurrence,

no prior radiation therapy (RT), and for patient who are unfit for surgery, or

As a single agent for PS-02 patients, or in combination (PS0-1) with paclitaxel, docetaxel, or

cetuximab (nasopharyngeal cancer) for the treatment of unresectable locoregional recurrence, or

as a secondary primary in patients who have received prior RT, or for distant metastases.




o considered for selected T4a patients who decline surgery.


o T3, N0-3 disease requiring (amenable to ) total laryngectomy following partial response

at the primary site to induction chemotherapy, or





o T1, N+, or

o T2-3, and any N Disease requiring (amenable to) pharyngectomy with total

laryngectomy.


o T1, N+ with partial response at the primary site and stable or improved disease in the

neck following induction chemotherapy, or

o T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy with

partial response at the primary site and stable, or improved disease in the neck following

induction chemotherapy, or

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121

o T4a, any N disease with partial response at the primary site and stable or improved

disease in the neck following induction chemotherapy, or

o can be considered for T1, N+, for T2-3, any N requiring (amenable to) pharyngectomy

with total laryngectomy, or for T4a, any N disease with complete response at the primary

site and stable, or improved disease in the neck following induction chemotherapy.


As a primary concurrent chemoradiation in combination with paclitaxel for patients with T3-4a,

N0, or for patients with any T, N1-3 disease who are candidates for but do not receive surgery.


As an adjuvant therapy in combination with fluorouracil following chemoradiation for:



For sequential chemoradiation for :

o T1, N1-3 disease

o T2-4, and N disease.

As a primary platinum based chemotherapy in combination with docetaxel, paclitaxel, or

cetuximab for any T, any N, or M1 disease,

As chemoradiation following platinum based chemotherapy for any T, any N, or M1 disease.


As a primary concurrent chemoradiation in combination with paclitaxel for treatment of:

o T2, N1 disease, or


o Any T, N2-3 disease.

For sequential chemoradiation following induction chemotherapy for:







surgery, or

o for T4a, N0-3 patients who decline surgery.

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partial response at the primary site to induction chemotherapy, or


surgery following partial response at the primary site to induction chemotherapy, or





o newly diagnosed T3-4a disease, or

o for patients who have declined surgery, or

o for cancer diagnosed after incomplete excision with gross residual disease.


For preoperative concurrent chemoradiation in combination with paclitaxel in select patients with

T3-4a, or N0 disease.

As a primary concurrent chemoradiation in combination with paclitaxel for T4b and any N

disease.


As the initial definitive treatment in:

o concurrent chemoradiation for >=N2 disease in combination with paclitaxel, or

o as sequential chemoradiation.

Hodgkin Lymphoma – Classical Hodgkin Lymphoma

When used as a component of GCD (gemcitabine, carboplatin and dexamethasone) or ICE

(ifosfamide, carboplatin and etoposide) regimen:

o as a second line therapy prior to autologous stem cell rescue for refractory disease, or

o as a salvage therapy with or without ISRT prior to autologous stem cell rescue, or

o as a second line therapy with or without ISRT for stage IA-IIA relapsed disease in

patients with no prior RT and failure at initial sites, or

o as a second line therapy for all other relapsed disease.

Hodgkin Lymphoma – Nodular Lymphocyte – Predominant Hodgkin Lymphoma

As a second line therapy with or without rituximab for symptomatic refractory or relapsed disease

as a component of:

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123

o GCD regimen, or

o ICE regimen.

Kidney Cancer

When used in combination with gemcitabine or paclitaxel for patients with collecting duct or

medullary subtypes.


When used in combination with pemetrexed for:





Melanoma

When used in combination with paclitaxel for:





Neuroendocrine Tumors – Adrenal Gland Tumors

When used as treatment for metastatic adrenal carcinoma in combination with etoposide with or

without doxorubicin or miltotane.

Neuroendocrine Tumors – Poorly Differentiated (High-Grade)/Large or Small Cell

When used as the primary treatment for:

o resectable disease, or

o unresectable locoregional disease, or

o metastatic disease.

Non-Hodgkin Lymphoma (NHL) – Adult T-Cell Leukemia/Lymphoma

When used for nonresponders to first line therapy for acute disease or lymphoma in candidates

for transplant as a component of ICE (ifosfamide, carboplatin, and etoposide) regimen.

NHL – AIDS-Related B-Cell Lymphoma

When used as a second line therapy with or without rituximab for relapse of AIDS related diffuse

large B-cell lymphoma, primary effusion lymphoma, and lymphoma associated with Castleman’s

PRN 8/2014

124

disease in patients with intention to proceed to high-dose therapy with autologous stem cell

rescue and as a component of:

o ICE regimen, or

o GDP regimen.

NHL – Burkitt Lymphoma

When used as a second line therapy for relapse of Burkitt lymphoma following complete response

as a component of RICE (rituximab, ifosfamide, carboplatin, and etoposide) regimen with

intrathecal methotrexate if not previously given.

NHL – Diffuse Large B-Cell Lymphoma

As a second line therapy with or without rituximab for relapsed or refractory disease in patients

with intention to proceed to high dose therapy with autologous stem cell rescue as a component

of:

o ICE regimen, or

o GDP regimen.

Used to treat primary mediastinal large B-cell lymphoma as a component of ICE regimen

following RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)

regimen.

NHL – Extranodal NK/T-Cell Lymphyoma, nasal type

When used for induction therapy as a component of DeVIC (dexamethasone, etoposide,

ifosfamide, and carboplatin) regimen with concurrent radiation.

NHL – Follicular Lymphoma

When used as a second line or subsequent therapy with or without rituximab for recurrent or


o ICE regimen, or

o GDP regimen.

NHL – Gastric MALT Lymphoma

When used as a second line therapy with or without rituximab for recurrent or progressive disease

in patients with the indications for treatment as a component of:

o ICE regimen, or

o GDP regimen.

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125

NHL – Mantle Cell Lymphoma

When used as induction therapy and a component of aggressive therapy with sequential

RCHOP/RICE regimen.

As a second line therapy with or without rituximab for relapsed, refractory, or progressive disease

as a component of:

o ICE regimen, or

o GDP regimen.

NHL – Mycosis Fungoides (MF)/Sezary Syndrome (SS)

Chemotherapy when used for tumors with histologic evidence of large cell transformation and

aggressive growth rate as a component of ICE regimen in candidates for transplant with:

o Stage IA-IIA MF with histologic evidence of folliculotropic or large cell transformation

or stage IIB with generalized extended tumor, transformed, and/or folliculotropic disease

in combination with skin direct therapy, or

o State IV non-Sezary or visceral disease.

NHL – Nongastric MALT Lymphoma

As a second line therapy with or without rituximab for recurrent stage I-II disease or for


o ICE regimen, or

o GDP regimen.

NHL – Peripheral T-Cell Lymphoma

As a first line therapy for patients with angioimmunoblastic T-cell lymphoma, peripheral T-cell

lymphoma not otherwise specified, ALK-negative anaplastic large cell lymphoma, or

enteropathy-associated T-cell lymphoma as a component of ICE regimen following CHOP

(cyclophosphamide, doxorubicin, vincristine, and prednisone) regimen.

As a second line therapy for relapsed or refractory angioimmunoblastic T-cell lymphoma,

peripheral T-cell lymphoma not otherwise specified, anaplastic large cell lymphoma, or

enteropathy associated T-cell lymphoma in candidates for transplant as a component of ICE

regimen.

NHL – Primary Cutaneous B-Cell Lymphoma

As a second line therapy with or without rituximab for primary cutaneous marginal zone or

follicle center lymphoma as a component of ICE or GDP regimen for:

o refractory generalized cutaneous disease, or

o relapsed generalized extracutaneous disease.

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126

Second line therapy with or without rituximab for relapsed or refractory primary cutaneous

diffuse large B-cell lymphoma, leg type in patients with intention to proceed to high-dose therapy

with autologous stem cell rescue as a component of:

o ICE regimen, or

o GDP regimen.

NHL – Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders

As a component of ICE (ifosfamide, carboplatin, and etoposide) regimen for relapsed or

refractory:

o primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or

o cutaneous ALCL with regional nodes (excludes systemic ALCL).

NHL – Splenic Marginal Zone Lymphoma

As a second line therapy with or without rituximab for progressive disease in patients with the

indications for treatment as a component of:

o ICE regimen, or

o GDP regimen.

Non-Melanoma Skin Cancers – Merkel Cell Carcinoma

When used as a single agent or in combination with etoposide as:

o a consideration for adjuvant treatment with or without radiation therapy for clinical N+

disease in select clinical circumstances, or

o treatment for distant metastatic disease or disseminated recurrence with or without

surgery or radiation.


When used as a preoperative concurrent chemoradiation in combination with pemetrexed for

patients with comorbidities or who are unable to tolerate cisplatin for:


1), or


or the mediastinum.

Used as a preoperative concurrent chemoradiation in combination with paclitaxel for patients

with comorbidities or who are unable to tolerate cisplatin followed by chemotherapy with 2

cycles of paclitaxel and carboplatin for T3 invasion, resectable T4 extension, N0-1 disease in the

chest wall, proximal airway, or mediastinum.

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127

Used in combination with paclitaxel for patients with comorbidities or who are unable to tolerate

cisplatin as:






chemotherapy.


pemetrexed for patients with comorbidities or who are unable to tolerate cisplatin for:



N1 disease, or





paclitaxel for patients with comorbidities or who are unable to tolerate cisplatin followed by




N1 disease, or




As an adjuvant chemotherapy in combination with paclitaxel for patients with comorbidities or

who are unable to tolerate cisplatin for:

o definitive radiation therapy in medically inoperable high risk stage IB (peripheral T2a,

N0), stage I (central T1ab-2a, N0), stage II (T1ab- 2ab, N1; T2b, N0), or stage IIB (T3,

N0) with negative mediastinal nodes and N0 disease, or

o for high risk, margin negative stage IB (T2a, N0) and IIA (T2b, N0, or)

o for margin positive stage IB (T2a, N0) and IIA (T2b, N0), or

o for margin positive stage IIA (T2b, N0) following radiation, or


o for margin negative stage IIIA (T1-3, N2; T3, N1), or

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128


N0-1), or


airway, and the mediastinum if not given as initial treatment, or

o for margin negative or margin positive, R1 T1-3 (including T3 with multiple nodules in




(T4), N0-1, or

o for margin negative or margin positive, R1 separate pulmonary nodule(s) in the same


As an adjuvant concurrent chemoradiation in combination with paclitaxel followed by









As an adjuvant concurrent chemoradiation in combination with pemetrexed for:








Or as a sequential chemoradiation in combination with paclitaxel as:

o the initial definitive therapy for medically inoperable stage IB (peripheral T2a, N0), stage

I (central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), or stage IIB (T3, N0) with

negative mediastinal nodes and N1 disease, or


N1), or,

o adjuvant therapy for margin negative T1-3, N2, or

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o adjuvant therapy for margin positive, R1 stage IIIA (T1-3, N2; T3, N1), or

o adjuvant therapy for margin positive, R1 T3 invasion or resectable T4 extension, N0-1


treatment.

As concurrent chemoradiation in combination with pemetrexed if radiation not previously given

for locoregional recurrence in the mediastinal lymph nodes or for superior vena cava obstruction:

o as a first line therapy for recurrence or metastasis:

o in combination with paclitaxel, docetaxel, gemcitabine, vinorelbine, etoposide,

vinblastine, pemetrexed (nonsquamous cell histology), or with albumin bound paclitaxel

in patients with performance status (PS) 0-2, or the elderly patient, or

o as a single agent in PS 2 or the elderly patient.

As a first line therapy for recurrence or metastasis in a carboplatin based regimen in combination

with bevacizumab in patients with performance status (PS) 0-1, tumors of nonsquamous cell


As a second line therapy for progression in patients with multiple symptomatic systemic lesions

in carboplatin based doublet therapy with or without bevacizumab:

o with or without erlotinib for sensitizing EGFR mutation positive tumors and prior

erlotinib or afatinib therapy, or

o for ALK-positive tumors and prior crizotinib and/or ceritinib therapy.

Occult Primary

For chemoradiation in combination with docetaxel or with paclitaxel with or without etoposide in


aggressive disease for localized disease with axillary or inguinal nodal involvement.

May be used in combination with docetaxel, or with paclitaxel with or without etoposide in

symptomatic patients with performance status (PS) 1-2, or asymptomatic patients with PS 0 and


o lung nodules or breast marker negative pleural effusion, or





Used in combination with paclitaxel or docetaxel in symptomatic patients with performance



PRN 8/2014

130


metastases.


When used as a neoadjuvant chemotherapy in combination with paclitaxel or docetaxel for bulky

stage III-IV disease in poor surgical candidates.

Used in combination with paclitaxel or docetaxel as:





Used in combination with paclitaxel or with docetaxel as:





In combination with paclitaxel or docetaxel for clinical relapse or recurrent disease as evidenced

by rising CA-125 levels in patients who have received no prior chemotherapy.

As a preferred therapy, if platinum sensitive, for persistent disease or recurrence:


o in combination with docetaxel, gemcitabine, or liposomal doxorubicin, or

o in combination with gemcitabine and bevacizumab if bevacizumab not previously

received.


When used in the initial treatment and in combination with etoposide or irinotecan for extensive

stage disease.

When used in combination with etoposide in patients with limited stage disease who are poor

candidates for cisplatin as:

o an initial treatment with or without radiation, or

o an adjuvant chemotherapy for pN0 disease, or

o an adjuvant concurrent chemoradiation for pN+ disease.

As a subsequent chemotherapy for patients with performance status 0-2 in combination with

etoposide or irinotecan and:

o if used as the original regimen, for relapse occurring more than 6 months following

complete or partial response or stable disease with initial treatment, or

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131

o if not used as original regimen, for primary progressive disease.

Soft Tissue Sarcoma – Rhabodomyosarcoma

As therapy when used in combination with etoposide for nonpleomorphic rhabodomyosarcoma.

Testicular Cancer

As a high dose chemotherapy in combination with etoposide alone or following paclitaxel and

ifosfamide for recurrent disease.

As a primary treatment and a single agent for patients with stage 1A-B disease.


When used as a postoperative treatment in combination with paclitaxel and radiation therapy for:

o thymic carcinoma after R1 or R2 resection, or

o thymoma after R2 resection.

As a first line therapy in combination with paclitaxel for:

o locally advanced disease, or

o isolated solitary metastasis, or




o in concurrent chemoradiation, or

o as chemotherapy for unresectable local tumors with or without distant disease.


When used as a primary treatment and a single agent or in combination with paclitaxel or

docetaxel when used:



o can be considered following palliative hysterectomy with bilateral salpingo-

oophorectomy with or without RT and/or hormonal therapy for extra abdominal or liver

disease.

For surgically staged patients as a single agent, or in combination with paclitaxel, or with

docetaxel as an adjuvant treatment:


with stage IB disease and histologic grade 3 tumors and adverse risk factors, or

PRN 8/2014

132



o with or without sequential tumor directed RT for stage IIIA, IIIB, and IIIC disease, or

o with or without sequential RT for stage IV disease, or

o as a single agent or in combination with paclitaxel, or docetaxel as adjuvant treatment

with sequential RT and vaginal brachytherapy with or without para-aortic RT for

incompletely surgically staged patients with histologic grade 3 tumors.

Single agent or in combination with paclitaxel or docetaxel:



or large-volume metastases, or

o with sequential tumor directed RT with or without brachytherapy for local recurrence in

patients with disease confined to the vagina, or in the pelvic, the para-aortic, or common

iliac lymph nodes, or




of recurrence.

As an adjuvant therapy single agent or in combination with paclitaxel or docetaxel and with or

without:


o sequential tumor directed radiation therapy for stage 1A disease with myometrial



When used in combination with docetaxel or paclitaxel for recurrent or residual disease.



o considered for initial treatment of intermediate and high-risk stage I disease, or

o for initial treatment of stage II-IV disease, or

o for clinical relapse in patients with stage II-IV disease.

Penile Cancer


features.

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133

Prostate Cancer


features.









New policy for palonosetron hydrochloride (Aloxi®)

Highmark Blue Cross Blue Shield‘s Medicare Advantage products, Freedom Blue PPO and

Security Blue HMO, have established new clinical criteria for the use of palonosetron

hydrochloride (Aloxi®). The new guidelines for Medicare Advantage Medical Policy I-52 will

become effective Sept. 1, 2014.

Aloxi may be considered medically necessary when any of the following criteria are met:

Prevention of chemotherapy induced nausea or vomiting from low or minimally emetogenic

cancer chemotherapy for members who have a treatment failure or contraindication to

Granisetron (Kytril) and Ondansetron (Zofran); or

Prevention of acute nausea or vomiting associated with initial and repeat courses of moderate or

highly emetogenic cancer chemotherapy; or

Prevention of postoperative nausea and vomiting (PONV) and there is a treatment failure or

contraindication to Ondansetron (Zofran).

Palonosetron hydrochloride (Aloxi) injection performed for indications other than those listed above will

be denied as not medically necessary.

Services denied as not reasonable and medically necessary, under section 1862(a) (1) of the Social



MA

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Criteria established for paclitaxel (Taxol®)


Security Blue HMO, will establish new clinical criteria for the use of paclitaxel (Taxol®). This

new Medicare Advantage Medical Policy will become effective Oct. 27, 2014.

The use of paclitaxel (Taxol) maybe considered medically necessary when used in the treatment of the

following condition(s):

Bladder Cancer

Primary treatment in combination with cisplatin and radiation therapy for clinical node-negative

stage T2, T3, and T4a disease for bladder preservation; or

Primary treatment as a single agent or in combination therapy for patients with clinical node-


status; or

Radiosensitizing chemotherapy given concurrently with radiation for palliation of metastases or

for pelvic recurrence after cystectomy; or

May be considered for recurrent or metastatic disease in:




Bladder Cancer - Primary Carcinoma of the Urethra

Used in combination with cisplatin and radiation therapy for:

o primary treatment for clinical stage T2 disease of the female urethra; or

o primary treatment for clinical stage T3-4 disease or palpable inguinal lymph nodes; or

o adjuvant treatment for clinical stage T2 disease with positive margins in the pendulous

urethra.

MA

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135

Single-agent therapy:

o as primary treatment for clinical stage T3-4, cN1-2 disease or cN1-2 palpable inguinal

lymph nodes; or






Bladder Cancer - Upper GU Tract Tumors





Bladder Cancer - Urothelial Carcinoma of the Prostate





Breast Cancer - Invasive

Preoperative systemic therapy for patients with stage IIA, IIB, or T3, N1, M0 disease who desire

breast preservation and fulfill criteria for breast-conserving surgery except for tumor size or for

locally advanced disease (stage IIIA, IIIB, or IIIC) for:

o following dose-dense AC (doxorubicin and cyclophosphamide) as a component of a


o following FEC/CEF (fluorouracil, epirubicin, and cyclophosphamide) regimen; or

o following FAC (fluorouracil/doxorubicin/cyclophosphamide) regimen; or


o in combination with trastuzumab following AC regimen (preferred regimen) for human


o in combination with trastuzumab and pertuzumab following AC regimen (preferred


early stage breast cancer.

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136

Adjuvant systemic therapy for stage I, IIA, IIB, or T3, N1, M0 disease or for locally advanced

disease (stage IIIA, IIIB, or IIIC) for:

o following dose dense AC (doxorubicin and cyclophosphamide) as a component of a


o following FEC/CEF regimen; or

o following FAC regimen; or


o in combination with trastuzumab following AC regimen as preferred regimen for human


o in combination with trastuzumab and pertuzumab following AC regimen (as preferred


early stage breast cancer if a pertuzumab-containing regimen was not used as

neoadjuvant therapy.

May be considered in combination with trastuzumab for low-risk stage I, human epidermal

growth factor receptor 2-positive disease particularly for patients not eligible for other standard

adjuvant regimens due to comorbidities; or

Preferred single agent or in combination with gemcitabine or bevacizumab for recurrent or

metastatic disease for:


with visceral crisis; or


endocrine therapy refractory; or



Used in combination with trastuzumab with or without carboplatin for recurrent or metastatic

disease as first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive

disease or as therapy for trastuzumab-exposed HER2-positive disease for:

o hormone receptor-positive with visceral crisis; or





or with symptomatic visceral disease for:

o as preferred first-line therapy in combination with pertuzumab and trastuzumab; or

PRN 8/2014

137


therapy beyond first-line therapy in patients previously treated with chemotherapy and


Breast Cancer- during pregnancy

Weekly paclitaxel can be used in pregnant women with confirmed breast cancer and no distant

metastases if clinically indicated by disease for:

o neoadjuvant chemotherapy in the second and early third trimesters; or

o adjuvant chemotherapy in the second and third trimesters if not used in the neoadjuvant

setting.

Cervical Cancer

First-line therapy as a single agent, in combination with carboplatin, or with cisplatin with or

without bevacizumab for:

o local/regional recurrence; or



Used in medically fit patients in combination with carboplatin as a preferred regimen, or with

cisplatin (definitive only), fluorouracil, or capecitabine for:

o preoperative chemoradiation for adenocarcinoma and for noncervical esophagus

squamous cell carcinoma for T1b, N+ or T2-4a, N0-N+; or

o definitive chemoradiation for patients who decline surgery and recommended for cervical

esophagus squamous cell carcinoma for T1b, N+ or T2-4a, N0-N+; or

o definitive chemoradiation for T4b.

Definitive concurrent chemoradiation in combination with carboplatin as a preferred regimen, or

with cisplatin, fluorouracil, or capecitabine for:

o for medically unfit patients with T1b, N0 tumors with poor prognostic features; or

o as primary treatment for T1b, N+, T2-T4a, N0-N+, or unresectable T4b disease for

patients who are unfit for or do not elect surgery.

Concurrent chemoradiation in combination with carboplatin as a preferred regimen, or with

cisplatin, fluorouracil, or capecitabine for locoregional recurrence in patients who have had

surgery but no prior chemoradiation for:

o palliative therapy for patients with Karnofsky performance score ≥60% or ECOG

performance score ≤2 as a single agent (preferred for second-line therapy) or in

combination with cisplatin (first line), or carboplatin (first line); or

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o T4b squamous cell carcinoma with invasion of the trachea, great vessels, and heart; or






score ≤2 in combination with ramucirumab as preferred second-line therapy for esophagogastric

junction adenocarcinoma for:


o primary treatment for T1b, N+, T2-4a, or unresectable T4b disease for patients who are



Gastric Cancer

Preoperative chemoradiation in combination with carboplatin as a preferred regimen or with

capecitabine or fluorouracil for resectable locoregional disease (T2 or higher by clinical staging,

any N) in medically fit patients; or

Primary treatment as paclitaxel-based chemoradiation for:

o unresectable locoregional disease in medically fit patients; or



score ≤2 as a single agent (preferred for second-line therapy) or in combination with cisplatin

(first line), carboplatin (first line), or ramucirumab (preferred second-line therapy) for:

o locoregional disease in medically unfit patients; or


o medically inoperable or unresectable residual disease following primary treatment; or

o unresectable locally advanced, locally recurrent or metastatic disease.


Primary concurrent chemoradiation for non-nasopharyngeal cancer in combination with cisplatin

or carboplatin for:



o locoregional recurrence in PS 0-2 patients who have not received prior radiation therapy.

Induction chemotherapy for non-nasopharyngeal cancer in combination with cisplatin and

fluorouracil in patients with performance status 0-1 for:

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139




therapy.

Therapy for:



recurrence and no prior radiation therapy (RT), or for patients who are unfit for surgery;

or

o single agent in PS 0-2 patients or in combination (PS 0-1) with cisplatin and cetuximab

(non-nasopharyngeal cancer) or with cisplatin or carboplatin for unresectable


distant metastases.




o consider for selected T4a patients who decline surgery.


o T3, N0-3 disease requiring (amenable to) total laryngectomy; or




o T1, N+; or




o T1, N+; or




Primary concurrent chemoradiation in combination with cisplatin or carboplatin for patients with

T3-4a, N0 or for patients with any T, N1-3 disease who are candidates for but do not receive

surgery.

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Induction chemotherapy in combination with cisplatin and epirubicin for:

o T1, N1-3 disease; or















surgery; or

o consider for T4a, N0-3 patients who decline surgery.




surgery; or








Consider preoperative concurrent chemoradiation in combination with cisplatin or carboplatin in

select patients with T3-4a, N0; or

Primary concurrent chemoradiation in combination with cisplatin or carboplatin for T4b, any N.

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Initial definitive treatment for:

o concurrent chemoradiation for ≥N2 disease in combination with cisplatin or carboplatin;

or

o induction chemotherapy in combination with cisplatin and fluorouracil.

Kidney Cancer

May be used in combination with carboplatin in patients with collecting duct or medullary

subtypes

Melanoma; or

Single agent or in combination with carboplatin for:

o unresectable stage III in-transit metastases; or

o local/satellite and/or in-transit unresectable recurrence; or

o incompletely resected or unresectable nodal recurrence; or



Preoperative concurrent chemoradiation in combination with carboplatin for patients with

comorbidities or who are unable to tolerate cisplatin followed by chemotherapy with 2 cycles of

paclitaxel and carboplatin for T3 invasion or resectable T4 extension, N0-1 disease in the chest

wall, proximal airway, or mediastinum; or

Used in combination with carboplatin for patients with comorbidities or who are unable to

tolerate cisplatin for:


the chest wall, proximal airway, or mediastinum; or

o induction chemotherapy with or without radiation for T1-2 or T3 (≥7 cm), N2, M0; or



chemotherapy.

Initial treatment as definitive concurrent chemoradiation in combination with carboplatin for

patients with comorbidities or who are unable to tolerate cisplatin followed by chemotherapy with

2 cycles of paclitaxel and carboplatin for:



N1 disease; or

o unresectable superior sulcus tumors (T4 extension, N0-1); or

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o unresectable stage IIIA (T4, N0-1); or

o T1-2, T3 (≥7cm), N2, M0; or

o T3 invasion, N2, M0; or

o stage IIIB (T1-3, N3 positive, M0); or


Adjuvant chemotherapy in combination with carboplatin for patients with comorbidities or who

are unable to tolerate cisplatin for:



stage IIB (T3, N0) with negative mediastinal nodes and N0 disease; or

o for high-risk, margin-negative stage IB (T2a, N0) and IIA (T2b, N0); or

o for margin-positive stage IB (T2a, N0) and IIA (T2b, N0); or

o for margin-positive stage IIA (T2b, N0) following radiation; or

o for stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1);or

o for margin-negative stage IIIA (T1-3, N2; T3, N1); or


N0-1)


airway, or mediastinum if not given as initial treatment; or


the same lobe), N2; or

o for T1-2, T3 (≥7 cm), N2, M0 with no apparent progression or local progression; or


(T4), N0-1; or



Adjuvant concurrent chemoradiation in combination with carboplatin followed by chemotherapy

with 2 cycles of paclitaxel and carboplatin for:

o margin-positive stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1); or

o margin-positive stage IIIA (T1-3, N2; T3, N1); or


proximal airway, or mediastinum if not given as initial treatment; or

o margin-positive T1-3 (including T3 with multiple nodules in the same lobe), N2; or



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Sequential chemoradiation in combination with carboplatin for:

o initial definitive therapy for medically inoperable stage IB (peripheral T2a, N0), stage I

(central T1ab-2a, N0), stage II (T1ab-2ab, N1 or T2b, N0), or stage IIB (T3, N0) with

negative mediastinal nodes and N1 disease; or


N1); or

o adjuvant therapy for margin-negative T1-3, N2; or

o adjuvant therapy for margin-positive, R1 stage IIIA (T1-3, N2; T3, N1); or

o adjuvant therapy for margin-positive, R1 T3 invasion or resectable T4 extension, N0-1


treatment.

First-line therapy for recurrence or metastasis for:

o in combination with cisplatin or carboplatin in performance status (PS) 0-2 or elderly

patients; or


First-line therapy in cisplatin- or carboplatin-based regimens in combination with bevacizumab

for recurrence or metastasis in patients with performance status 0-1, tumors of nonsquamous cell


Occult Primary

Chemoradiation in combination with carboplatin with or without etoposide in symptomatic


disease for localized disease with axillary or inguinal nodal involvement; or

Used in combination with carboplatin with or without etoposide in symptomatic patients with


o lung nodules or breast marker-negative pleural effusion; or

o resectable liver disease; or


histology in selected patients; or


Used in combination with carboplatin or cisplatin in symptomatic patients with performance


o chemoradiation in patients with axillary or inguinal nodal involvement; or


metastases.

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Ovarian Cancer - Epithelial Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer

Neoadjuvant chemotherapy in combination with carboplatin for bulky stage III-IV disease in poor

surgical candidates; or

Used in combination with carboplatin for:

o primary treatment for incompletely staged (stage IA-IB, grade 2-3 or clear cell and stage

IC) patients with no suspected residual disease; or

o primary adjuvant treatment for pathologic stage IA-IB (grades 2-3 or clear cell) and for


Used in combination with carboplatin with or without bevacizumab for:

o primary treatment for incompletely staged (stage II-IV) patients with suspected

unresectable residual disease; or

o primary adjuvant treatment for pathologic stage II-IV disease following completion


Intraperitoneal (IP) chemotherapy in combination with IV paclitaxel and IP cisplatin for less than

1 cm optimally debulked stage II and III disease; or

Post-remission chemotherapy as a single agent for stage II-IV patients in complete clinical

remission following primary treatment; or


levels in patients who have received no prior chemotherapy; or

Therapy for persistent disease or recurrence for:

o single agent; or

o as preferred therapy, if platinum-resistant, in combination with bevacizumab if

bevacizumab not previously received.

Preferred therapy, if platinum-sensitive, in combination with carboplatin for persistent disease or

recurrence.

Ovarian Cancer - Malignant Germ Cell Tumors

Used as a component of TIP (paclitaxel, ifosfamide, and cisplatin) regimen as follow-up

treatment for patients with persistently elevated markers (alpha-fetoprotein and/or beta-human

chorionic gonadotrophin) following initial treatment for:

o embryonal tumor; or

o endodermal sinus tumor; or

o stage II-IV dysgerminoma; or

o stage I (grade 2-3) or stage II-IV immature teratoma.

Used as a single agent, in combination with ifosfamide, carboplatin, or gemcitabine, or in TIP

(paclitaxel, ifosfamide, and cisplatin) regimen for recurrent or residual disease.

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Ovarian Cancer - Malignant Sex Cord-Stromal Tumors

Initial treatment in combination with carboplatin for:

o intermediate- and high-risk stage I disease; or

o stage II-IV disease.

Single agent or in combination with carboplatin or ifosfamide for clinical relapse in patients with

stage II-IV disease.

Penile Cancer

Used in combination with cisplatin and ifosfamide for:

o neoadjuvant treatment for enlarged (≥4 cm) biopsy positive unilateral or mobile inguinal

lymph nodes; or

o neoadjuvant treatment for enlarged (>4 cm) biopsy positive multiple or bilateral inguinal

lymph nodes; or

o neoadjuvant treatment for potentially resectable enlarged (≥4 cm) pelvic lymph nodes; or

o adjuvant treatment of tumors with high-risk pathologic features if not given

preoperatively; or

o consider for first-line treatment for locally recurrent disease in the inguinal region.

Used for the treatment of metastatic disease for:

o first-line in combination with cisplatin and ifosfamide; or

o second-line as a single agent.


Subsequent chemotherapy for patients with performance status 0-2 as a single agent for:

o relapse within 6 months following complete or partial response with initial treatment; or


Soft Tissue Sarcoma - Angiosarcoma

Used as a single agent for angiosarcoma.

Testicular Cancer

As a component of TIP (paclitaxel, ifosfamide, and cisplatin) regimen as second-line

chemotherapy for persistent or recurrent disease following prior chemotherapy; or

As a component of TIP (paclitaxel, ifosfamide, and cisplatin) regimen for treatment of residual

embryonal, yolk sac, choriocarcinoma, or seminoma elements following surgical resection of all

residual masses post-chemotherapy; or

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High-dose chemotherapy in combination with ifosfamide followed by carboplatin and etoposide

for recurrent disease; or

As palliative chemotherapy in combination with gemcitabine with or without oxaliplatin after

second-line or high-dose chemotherapy regimens.


Postoperative treatment in combination with carboplatin and radiation therapy for:

o thymic carcinoma after R1 or R2 resection; or

o thymoma after R2 resection; or

First-line therapy in combination with carboplatin for:

o locally advanced disease; or

o isolated solitary metastasis; or


Second-line therapy as a single agent following radiation therapy for locally advanced


Thyroid Carcinoma - Anaplastic Carcinoma

Used as a single agent or in combination with carboplatin for:

o use in concurrent chemoradiation

o chemotherapy for unresectable local tumor with or without distant disease.

Uterine Neoplasms - Endometrial Carcinoma

Primary treatment as a single agent or in combination with cisplatin and doxorubicin or with

carboplatin for:

o use with sequential radiation therapy (RT) and brachytherapy with or without surgery for

extrauterine pelvic disease; or



For surgically staged patients as a single agent or in combination with cisplatin and doxorubicin

or with carboplatin as adjuvant treatment for:

o use with sequential pelvic radiation therapy (RT) and/or vaginal brachytherapy in patients

with stage IB disease with histologic grade 3 tumors and adverse risk factors; or

o use with sequential pelvic RT and vaginal brachytherapy in patients with stage II disease

with histologic grade 3 tumors; or

o use with or without sequential tumor-directed RT for stage IIIA, IIIB, and IIIC disease; or

o use with or without sequential RT for stage IV disease.

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Single agent or in combination with cisplatin and doxorubicin or with carboplatin as adjuvant

treatment with sequential RT and vaginal brachytherapy with or without para-aortic RT for

incompletely surgically staged patients with histologic grade 3 tumors; or

Single agent or in combination with cisplatin and doxorubicin or with carboplatin for:

o disseminated metastases that have progressed on hormonal therapy; or

o use with or without sequential palliative radiation therapy (RT) for symptomatic, grade 2-

3, or large-volume metastases; or

o use with sequential tumor-directed RT with or without brachytherapy for local recurrence

in patients with disease confined to the vagina or in pelvic, para-aortic, or common iliac

lymph nodes; or

o use with or without sequential tumor-directed RT for microscopic upper abdominal or

peritoneal recurrences; or


of recurrence.

Adjuvant therapy as a single agent or in combination with carboplatin or with cisplatin and

doxorubicin and with or without:




Adjuvant therapy in combination with ifosfamide with or without:



invasion or stage IB-IV disease

AIDS-related Kaposi sarcoma.

The use of paclitaxel (Taxol) for all other indications is considered experimental/investigational, and

therefore, non-covered. Peer-reviewed literature does not support the use of Paclitaxel (Taxol) for any

indications other than those listed on the medical policy.

For further information, refer to Medicare Advantage Medical Policy I-54, Paclitaxel (Taxol®).

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Clinical criteria established for bendamustine (Treanda®)


Security Blue HMO, will establish new clinical criteria for the use of bendamustine (Treanda®).

Medicare Advantage Medical Policy I-55 will become effective Oct. 27, 2014.

The use of bendamustine (Treanda) may be considered medically necessary for the following conditions:

Hodgkin Lymphoma

Classical Hodgkin lymphoma for:

o third-line therapy or salvage therapy as a single agent prior to autologous stem cell rescue

for progressive disease or for relapsed disease in patients initially treated with

chemotherapy, with or without radiation therapy.

Lymphocyte-predominant Hodgkin lymphoma (LPHL) for:

o Second-line therapy, with or without rituximab (Rituxan®), for symptomatic progressive

disease or for relapsed disease.

Multiple Myeloma for:

Salvage therapy on or off clinical trials for disease relapse or for progressive or refractory disease,

as a single agent or in combination with lenalidomide and dexamethasone.

Non-Hodgkin Lymphoma (NHL):

Chronic lymphocytic leukemia (CLL), including hairy cell leukemia and small lymphocytic

lymphoma (SLL), without del(17p) or with or without del(11q) for:

o As first-line therapy with or without rituximab (Rituxan) for stage II-IV disease (as

referenced in the Rai Staging System or Benet Classification for CLL); or

o With or without rituximab (Rituxan) for relapsed or refractory disease.

Indolent B-cell lymphoma for:

o For progressive disease during or within six months of treatment with rituximab

(Rituxan) or a rituximab-containing regimen.

AIDS-related B-cell lymphoma for:

o Non-candidates of high-dose therapy; or

o Second-line therapy for relapsed disease, with or without rituximab (Rituxan).

Diffuse large B-cell lymphoma for:

o Second-line therapy with or without rituximab for relapsed or refractory disease in

noncandidates for high-dose therapy.

Follicular lymphoma and nodal marginal zone lymphoma for:

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149

o First-line therapy with rituximab (Rituxan); or

o Second-line or subsequent therapy, with or without rituximab (Rituxan).

Gastric MALT (mucosa-associated lymphoid tissue) lymphoma for:

o first-line therapy for stage IIIE-IV disease in combination with rituximab

o second-line therapy for recurrent or progressive disease as a single agent or in

combination with rituximab.

Mantle cell lymphoma for:

o With rituximab (Rituxan) as a less-aggressive induction therapy; or

o Second-line therapy with or without rituximab (Rituxan) for relapsed, refractory, or

progressive disease.

Non-gastric MALT lymphoma for:

o First-line therapy for stage III-IV disease with rituximab (Rituxan); or

o Second-line therapy for recurrent stage I-II disease or for progressive disease, with or

without rituximab (Rituxan).

Primary cutaneous B-cell lymphoma-Primary cutaneous marginal zone or follicle center B-cell

lymphoma for:

o First-line therapy for newly diagnosed generalized extracutaneous disease with rituximab

(Rituxan); or

o Second-line therapy for refractory generalized cutaneous disease or relapsed generalized

extracutaneous disease, with or without rituximab (Rituxan), or as a component of BVR

(bendamustine, bortezomib, and rituximab) regimen.

Primary cutaneous diffuse large B-cell lymphoma, leg type in noncandidates for high-dose

therapy for:

o Second-line therapy for relapsed or refractory disease, with or without rituximab

(Rituxan).

Splenic marginal zone lymphoma for:

o First-line therapy with rituximab (Rituxan) for disease progression following initial

treatment for splenomegaly; or

o Second-line therapy for progressive disease, with or without rituximab (Rituxan).

Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma

Used with or without rituximab for:

o primary therapy; or

o salvage therapy for disease that does not respond to primary therapy or for progressive or

relapsed disease.

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The use of bendamustine (Treanda) for all other indications is considered experimental/investigational,

and therefore, non-covered. Peer reviewed literature does not support the use of bendamustine (Treanda)

for any indications other than those listed on this medical policy.


Coverage criteria established for granulocyte colony-stimulating

factors


Security Blue HMO, have established new clinical criteria for the use granulocyte colony-

stimulating factors. This new Medicare Advantage Medical Policy will become effective Sept. 1,

2014.

Filgrastim (Neupogen)(J1442) may be considered medically necessary when used for any of the

following:

Primary prophylaxis of febrile neutropenia (FN) in individuals with a risk of FN of 20% or

greater based on chemotherapy regimen.

Primary prophylaxis of developing FN is greater than or equal to 10% and less than or equal to

20% based on chemotherapy regimen and individuals have one or more of the following risk

factors for FN:

o age greater than 65 years; or

o poor performance status; or

o previous episodes of FN; or

o history of previous chemotherapy or radiation therapy; or

o after completion of combined chemoradiotherapy; or

o bone marrow involvement by tumor producing cytopenias; or

o preexisting neutropenia; or

o poor nutritional status; or

o poor renal function; or

o liver dysfunction (i.e., elevated bilirubin); or

o the presence of open wounds or active infections; or

o recent surgery (generally within the past 12 weeks); or

o advanced cancer; or

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o other serious comorbidities.

Secondary prophylaxis of FN in individuals who experienced a neutropenic complication from a

prior cycle of chemotherapy (for which primary prophylaxis was not received), in which a

reduced dose may compromise disease-free or overall survival or treatment outcome.

Adjunctive treatment of individuals with FN and high risk for infection-associated complications

as demonstrated by any of the following:

o expected prolonged (greater than 10 days) and profound (less than 0.1 x 109/L)

neutropenia; or


o uncontrolled primary disease; or

o pneumonia; or

o hypotension and multi organ dysfunction (sepsis syndrome); or

o invasive fungal infection; or

o hospitalized at the time of the development of fever.

In an individual with acute lymphocytic leukemia (ALL) after completion of the first few days of

initial induction chemotherapy or first post-remission course of chemotherapy; or

Use in adult individuals with acute myeloid leukemia (AML) shortly after the completion of

induction or repeat induction chemotherapy, or after the completion of consolidation

chemotherapy for AML; or

Treatment of moderate to severe aplastic anemia; or

Treatment of severe neutropenia in individuals with hairy cell leukemia; or

In an individual with myelodysplastic syndromes (MDS) with severe neutropenia (absolute

neutrophil count (ANC) less than or equal to 500 mm3 or experiencing recurrent infection; or

In an individual receiving dose dense therapy (treatment given more frequently, such as every

two weeks instead of every three weeks) for adjuvant treatment of breast cancer; or

Chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.,

fever, infections, oropharyngeal ulcers) in symptomatic individuals with congenital neutropenia,

cyclic neutropenia, or idiopathic neutropenia; or

Treatment of (non-chemotherapy) drug-induced neutropenia; or

Treatment of low neutrophil counts in individuals with glycogen storage disease type 1b; or

Treatment for neutropenia associated with human immunodeficiency virus (HIV) infection and

antiretroviral therapy; or

In individuals receiving radiation therapy in the absence of chemotherapy if prolonged delays

secondary to neutropenia are expected; or

After accidental or intentional total body radiation of 3 to 10 Grays (Gy); or

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152

After autologous hematopoietic progenitor stem cell transplant (HPCT/HSCT); or

To mobilize progenitor cells into peripheral blood for collection by leukapheresis, as an adjunct

to peripheral blood/hematopoietic stem cell transplantation (PBSCT/PHSCT); or

Use as an alternate or adjunct to donor leukocyte infusions (DLI) in individuals with leukemic

relapse after an allogeneic hematopoietic stem cell transplant.

Pegfilgrastim (Neulasta™)(J2505) may be considered medically necessary when used for any of the

following:

Primary prophylaxis of febrile neutropenia (FN) in individuals with a risk of FN of 20% or

greater based on chemotherapy regimen.

Primary prophylaxis of developing FN is greater than or equal to 10% and less than or equal to

20% based on chemotherapy regimen and individuals have one or more of the following risk

factors for FN:


o poor performance status; or

o previous episodes of FN; or

o history of previous chemotherapy or radiation therapy; or

o after completion of combined chemoradiotherapy; or

o bone marrow involvement by tumor producing cytopenias; or

o preexisting neutropenia; or

o poor nutritional status; or

o poor renal function; or

o liver dysfunction (i.e., elevated bilirubin); or

o the presence of open wounds or active infections; or

o recent surgery (generally within the past 12 weeks); or

o advanced cancer; or

o other serious comorbidities.

Secondary prophylaxis of FN in individuals who experienced a neutropenic complication from a

prior cycle of chemotherapy (for which primary prophylaxis was not received), in which a

reduced dose may compromise disease-free or overall survival or treatment outcome.

Adjunctive treatment of individuals with FN and high risk for infection-associated complications

as demonstrated by any of the following:

o expected prolonged (greater than 10 days) and profound (less than 0.1 x 109/L)

neutropenia; or


o uncontrolled primary disease; or

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o pneumonia; or

o hypotension and multi organ dysfunction (sepsis syndrome); or

o invasive fungal infection; or

o hospitalized at the time of the development of fever.

In an individual with acute lymphocytic leukemia (ALL) after completion of the first few days of

initial induction chemotherapy or first post-remission course of chemotherapy; or

In an individual with myelodysplastic syndromes (MDS) with severe neutropenia (absolute

neutrophil count (ANC) less than or equal to 500 mm3 or experiencing recurrent infection; or

In an individual receiving dose dense therapy (treatment given more frequently, such as every

two weeks instead of every three weeks) for adjuvant treatment of breast cancer; or

After autologous hematopoietic progenitor stem cell transplant (HPCT/HSCT).

The use of colony stimulating factors (filgrastim and pegfilgrastim) is considered not medically necessary

for any of the following:

As prophylaxis for FN, except when criteria above are met; or

As treatment of neutropenia in individuals who are afebrile, except when criteria above are met;

or

As adjunctive therapy in individuals with uncomplicated febrile neutropenia, defined as: fever

less than 10 days duration, no evidence of pneumonia, cellulitis, abscess, sinusitis, hypotension,

multi-organ dysfunction, or invasive fungal infection; and no uncontrolled malignancies; or

Chemo sensitization of myeloid leukemias; or

As prophylaxis for FN during concomitant chemotherapy and radiation therapy; or

Continued use if no response is seen within 28-42 days (individuals who have failed to respond

within this time frame are considered non-responders); or

For uses not meeting the criteria above.







Note: Coverage for this medication is based on the patient's condition, the appropriateness of the dose and

route of administration, based on the clinical condition and the standard of medical practice regarding the

effectiveness of the drug for the diagnosis and condition.

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154



Criteria established for cetuximab (Erbitux®)


Security Blue HMO, have established new clinical criteria for the use of Cetuximab (Erbitux®).

This new Medicare Advantage Medical Policy will become effective Oct. 27, 2014.

The use of Cetuximab (Erbitux) may be considered medically necessary for conditions:

Colon Cancer

Used in combination with FOLFIRI (fluorouracil, leucovorin, and irinotecan) regimen for tumors

expressing KRAS/NRAS wild-type gene for:

o perioperative therapy for patients with synchronous liver and/or lung metastases or for

patients with resectable metachronous metastases who received previous chemotherapy;

or

o therapy for patients with unresectable synchronous liver and/or lung metastases, with

synchronous abdominal/peritoneal metastases, or with unresectable metachronous

metastases; or


(fluorouracil, leucovorin, and oxaliplatin) within the past 12 months in combination with

irinotecan for tumors expressing KRAS/NRAS wild-type gene; or

Initial therapy for patients with tumors expressing KRAS/NRAS wild-type gene who have

unresectable advanced or metastatic disease for:

o in combination with FOLFIRI regimen for patients who can tolerate intensive therapy; or








bevacizumab; or


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Primary concurrent chemoradiation for non-nasopharyngeal cancer as a single agent for:



o locoregional recurrence in PS 0-2 patients who have not received prior radiation therapy;

or

Sequential chemoradiation following induction chemotherapy in performance status 0-1 patients

with non-nasopharyngeal cancer for:

o newly diagnosed T4b, any N or unresectable nodal disease with no metastases, or patients



therapy; or

Therapy as a:

o single agent for patients with non-nasopharyngeal cancer with performance status (PS) 3

with newly diagnosed T4b, any N, unresectable nodal disease with no metastases, or with

unresectable locoregional recurrence and no prior radiation therapy (RT) or for patients

who are unfit for surgery; or

o single agent (non-nasopharyngeal cancer) in PS 0-2 patients or in combination (PS 0-1)

with carboplatin with (non-nasopharyngeal cancer) or without (nasopharyngeal cancer)

fluorouracil, in combination with cisplatin with or without fluorouracil, docetaxel, or

paclitaxel (non-nasopharyngeal cancer), for unresectable locoregional recurrence or

second primary in patients who have received prior RT or for distant metastases.




o consider for selected T4a patients who decline surgery; or


o for T3, N0-3 disease requiring (amenable to) total laryngectomy following partial

response at the primary site to induction chemotherapy; or





o T1, N+; or

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o T4a, any N disease; or


o for T1, N+ with partial response at the primary site and stable or improved disease in the

neck following induction chemotherapy; or

o for T2-3, any N disease requiring (amenable to) pharyngectomy with total laryngectomy

with partial response at the primary site and stable or improved disease in the neck

following induction chemotherapy; or

o for T4a, any N disease with partial response at the primary site and stable or improved

disease in the neck following induction chemotherapy; or

o consider for T1, N+, for T2-3, any N requiring (amenable to) pharyngectomy with total

laryngectomy, or for T4a, any N disease with complete response at the primary site and

stable or improved disease in the neck following induction chemotherapy.


Primary concurrent chemoradiation as a single agent for patients with T3-4a, N0 or for patients

with any T, N1-3 disease who are candidates for but do not receive surgery.


Primary therapy in combination with carboplatin for any T, any N, M1 disease.





o any T, N2-3 disease; or

Sequential chemoradiation following induction chemotherapy for:







surgery; or

o consider for T4a, N0-3 patients who decline surgery; or

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Sequential chemoradiation for:


partial response at the primary site to induction chemotherapy


surgery following partial response at the primary site to induction chemotherapy









Consider preoperative concurrent chemoradiation as a single agent for select patients with T3-4a,

N0; or

Primary concurrent chemoradiation as a single agent for T4b, any N.


Initial definitive treatment as:

Concurrent chemoradiation for ≥N2 disease; or

Sequential chemoradiation.

Non-Melanoma Skin Cancers - Basal Cell and Squamous Cell Skin Cancers

Treatment of squamous cell skin cancer for regional recurrence or distant metastases.


First-line therapy for recurrence or metastasis in combination with vinorelbine and cisplatin in

patients with performance status 0-1; or

Single-agent continuation maintenance therapy if given first line with chemotherapy for

recurrence or metastasis in patients with performance status 0-1 who achieve tumor response or

stable disease following first-line chemotherapy.

Rectal Cancer

Used in combination with FOLFIRI regimen for tumors expressing KRAS/NRAS wild-type gene

as:

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o neoadjuvant therapy for patients with synchronous metastases; or

o adjuvant therapy for patients with resected synchronous metastases who received

neoadjuvant chemoradiation ; or

o perioperative therapy for patients with resectable metachronous metastases who received

previous chemotherapy; or

o therapy for patients with unresectable metachronous metastases; or

o primary therapy for patients with unresectable synchronous metastases or who are

medically inoperable; or


within the past 12 months in combination with irinotecan for tumors expressing KRAS/NRAS

wild-type gene; or

Initial therapy for patients with tumors expressing KRAS/NRAS wild-type gene who have T4

and/or locally unresectable or medically inoperable disease or have unresectable advanced or

metastatic disease:

o in combination with FOLFIRI regimen for those who can tolerate intensive therapy; or








bevacizumab; or


The use of cetuximab (Erbitux) for all other indications is considered experimental/investigational, and

therefore, non-covered. Peer reviewed literature does not support the use of cetuximab (Erbitux) for any

indications other than those listed on the medical policy.

For further information, refer to Medical Policy I-69, Cetuximab (Erbitux®).

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Clinical criteria established for pemetrexed (Alimta®)


Security Blue HMO, have established new clinical criteria for the use of pemetrexed (Alimta®).

This new Medicare Advantage Medical Policy will become effective Oct. 27, 2014.

The use of pemetrexed (Alimta) may be considered medically necessary when used in the treatment of the

following condition(s):

Bladder Cancer


Bladder Cancer – Primary Carcinoma of the Urethra:






Central Nervous System Cancers – Primary CNS Lymphoma

As a single-agent for treatment of progressive or recurrent disease in patients who have received

prior methotrexate-based regimen without radiation therapy (RT):

o after prolonged response to prior regimen, or

o in combination with RT after short or no response to prior regimen.

Considered systemic treatment as a single agent for progressive or recurrent disease in patients

with prior whole brain radiation therapy.


As an induction therapy in combination with cisplatin for medically operable clinical stage I-II

disease.

Used as a single agent or in combination with cisplatin or carboplatin for:

o treatment of unresectable or medically inoperable clinical stage I-II disease and tumors of

epithelial or mixed histology, or

o treatment of resected clinical stage I-II disease in patients not treated with induction

chemotherapy, or

o treatment of clinical stage IV disease or tumors of sarcomatoid histology.

MA

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As a second-line treatment and a single agent if:

o not administered first line, or

o administered first line as rechallenge and had good sustained response at the time initial

chemotherapy was interrupted.


As a preoperative concurrent chemoradiation in combination with cisplatin or carboplatin for:


1), or


or mediastinum.

Can be used in combination with cisplatin as:

o a neoadjuvant chemotherapy for T3 invasion or resectable T4 extension, N0-1 disease in


o induction chemotherapy with or without radiation for T1-2, T3 (≥7cm), N2, M0, or


nodules in the same lobe) and as an alternative for patients likely to receive adjuvant

chemotherapy.

Used as the initial treatment as definitive concurrent chemoradiation in combination with

carboplatin or cisplatin for:



N1 disease, or


o unresectable stage IIIA (T4, N0-1), or

o T1-2 or T3 (≥7 cm), N2, M0, or


o stage IIIB (T1-3, N3 positive, M0), or

o contralateral or ipsilateral mediastinal node-positive stage IIIB (T4 extension, N2-3.

As adjuvant chemotherapy in combination with cisplatin:







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N0-1), or







(T4), N0-1, or



As adjuvant concurrent chemoradiation in combination with cisplatin or carboplatin for tumors of

nonsquamous cell histology for:

o margin-positive stage IIA (T1ab-2a, N1) and IIB (T3, N0; T2b, N1), or

o margin-positive stage IIIA (T1-3, N2; T3, N1), or



o margin-positive T1-3 (including T3 with multiple nodules in the same lobe), N2, or



Concurrent chemoradiation in combination with carboplatin or cisplatin if radiation not

previously given for locoregional recurrence in the mediastinal lymph nodes or for superior vena

cava obstruction.

As first-line therapy for recurrence or metastasis for tumors of nonsquamous cell histology:

o in combination with cisplatin or carboplatin in patients with performance status (PS) 0-2

or elderly patients, or

o in cisplatin- or carboplatin-based regimens in combination with bevacizumab in patients

with PS 0-1, tumors of nonsquamous cell histology, and no history of recent hemoptysis,

or


Therapy for recurrence or metastasis in patients with performance status 0-2 with tumors of

nonsquamous cell histology who achieve tumor response or stable disease following first-line

chemotherapy as:

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o a single agent for continuation maintenance therapy if given first line with chemotherapy

or in combination with bevacizumab if bevacizumab previously used with a first-line

pemetrexed/platinum chemotherapy regimen, or

o a single agent for switch maintenance.

As a single agent if not already given for progressive disease in patients with performance status

0-2 with tumors of nonsquamous cell histology or as a:

o second-line therapy in patients with negative or unknown EGFR mutation status, or

o third-line therapy if not already given.


As a single agent therapy for persistent disease or recurrence.


As a second line therapy single agent following radiation therapy for locally advanced










Criteria for natalizumab (Tysabri®) established


Security Blue HMO, have established new clinical criteria for the use of natalizumab (Tysabri®).

The new guidelines will become effective Oct. 27, 2014.

Natalizumab (Tysabri) is a recombinant humanized IgG4k monoclonal antibody produced in murine

myeloma cells. Natalizumab contains human framework regions and the complementarity determining

regions of a murine antibody that binds to a 4-integrin.

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Multiple sclerosis

Natalizumab is indicated as a monotherapy for treatment of adult individuals with:

A documented diagnosis of relapsing-remitting or relapsing secondary progressive multiple

sclerosis; and

Are initiating therapy for the first time or individuals who were already started on natalizumab

and continuing therapy.

Adult individual must have at least one clinical relapse documented (e.g., functional disability,

hospitalization, acute steroid therapy, etc.) during the prior year; and

Have had an inadequate response to, or are unable to tolerate at least ONE of the alternative

multiple sclerosis therapies:

o Interferon beta 1a (Avonex®, Rebif®); or

o Interferon beta 1b (Betaseron, extavia); or

o Glatiramer acetate [Copaxone®]); or

o Fingolimod (Gilenya); or

o Dimethyl fumarate (Tecfidera®); or

o Teriflunomide (Aubagio®); or

o Has highly active or aggressive disease according to the prescribing physician, (must be a

neurologist or physician who specializes in the treatment of multiple sclerosis).

Natalizumab is not approved for combination therapy with interferon’s (e.g., Rebif, Betaseron, Extavia)

or copaxone, Avonex, Aubagio, and Gilenya.

Because natalizumab increases the risk of progressive multifocal leukoencephalopathy (PML), an

opportunistic viral infection of the brain that usually leads to death or severe disability, it is recommended

that natalizumab be reserved for use in selected patients with relapsing remitting disease who have failed

other therapies either through continued disease activity or medication intolerance, or who have a

particularly aggressive initial disease course.

The recommended dose of TYSABRI for multiple sclerosis is 300 mg intravenous infusion over one hour

every four weeks.

Crohn's disease

For the adult individual who has been diagnosed with moderately to severely active Crohn's

disease with evidence of inflammation; and

Who has had an inadequate response to, or are unable to tolerate conventional Crohn's disease

therapies, e.g. oral corticosteroids or immunosuppressant and

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Treatment failure or intolerance to ONE TNF-αlpha inhibitor (e.g., Humira or infliximab).

Natalizumab should not be used in combination with immunosuppressants (e.g., 6-mercaptopurine,

azathioprine, cyclosporine, or methotrexate) or inhibitors of TNF-α (e.g., adalimumab, infliximab).

Aminosalicylates may be continued during treatment with natalizumab.

Coverage will be limited to one 300 mg intravenous infusion every four weeks.

If the patient with Crohn's disease has not experienced therapeutic benefit by 12 weeks of induction

therapy, discontinue natalizumab. For patients with Crohn's disease that start natalizumab while on

chronic oral corticosteroids, commence steroid tapering as soon as a therapeutic benefit of natalizumab

has occurred; if the patient with Crohn's disease cannot be tapered off to oral corticosteroids within six

months of starting natalizumab, discontinue natalizumab.

Other than the initial six-month taper, prescribers should consider discontinuing natalizumab for patients

who require additional steroid use that exceeds three months in a calendar year to control their Crohn's

disease.

Natalizumab is not approved for use in patients under age 18.

Because of the risk of PML, natalizumab is available only through a special restricted distribution

program called the TOUCH™ Prescribing Program. Natalizumab must be administered only to multiple

sclerosis patients registered in the MS TOUCH™ Prescribing Program and Crohn's disease patients

registered in the CD TOUCH™ Prescribing Program.

Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be

suggestive of PML. Tysabri dosing should be withheld immediately at the first sign or symptom

suggestive of PML. For diagnosis, an evaluation that includes a gadolinium-enhanced magnetic resonance

imaging (MRI) scans of the brain and, when indicated, cerebrospinal fluid analysis for JC viral DNA is

recommended.

The use of natalizumab for any other indication not listed in the coverage criteria above is considered

experimental/investigational, and therefore, not covered.





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For more information see Medicare Advantage Medical Policy I-85.

New codes

Here are 5 new codes that will be available for your reporting purposes on Oct. 1, 2014.

Code Terminology Effective

K0901 Knee orthosis (KO), single upright, thigh and calf, with adjustable

flexion and extension joint (unicentric or polycentric), medial-lateral

and rotation control, with or without varus/valgus adjustment,

prefabricated, off-the-shelf

10/01/2014

K0902 Knee orthosis (KO), double upright, thigh and calf, with adjustable

flexion and extension joint (unicentric or polycentric), medial-lateral

and rotation control, with or without varus/valgus adjustment,

prefabricated, off-the-shelf

10/01/2014

Q9972 Injection, Epoetin Beta, 1 microgram, (For ESRD On Dialysis) 10/01/2014

Q9973 Injection, Epoetin Beta, 1 microgram, (Non-ESRD use) 10/01/2014

S8032 Low-dose Computed Tomography For Lung Cancer Screening 10/01/2014

Codes

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Comments on these new medical policies?

We want to know what you think about our new medical policy changes. Send us an email with any

questions or comments that you may have on the new medical policies in this edition of PRN.

Write to us at [email protected].

PRN (Policy, Review & News) is the bimonthly newsletter for most health care professionals (and office

staff) who participate in our networks and submit claims to Highmark using the 837P HIPAA transaction

or the CMS 1500 form.

PRN focuses only on medical policy and claims administration updates, including coding guidelines and

procedure code revisions, and is the sole source for this information. For all other news, information and

updates, be sure to read Provider News, available on the Provider Resource Center at

www.highmarkbcbs.com.

Acknowledgement

The five-digit numeric codes that appear in PRN were obtained from the Current Procedural Terminology, as contained in CPT-2014, Copyright 2013, by the American Medical Association. PRN includes CPT descriptive terms

and numeric procedure codes and modifiers that are copyrighted by the American Medical Association. These procedure codes and modifiers are used for reporting medical services and procedures.

About this newsletter

mailto:[email protected]


PRN 8/2014

167

Contents Vol. 2014, No. 4

News

UCR and Premier Blue Shield reimbursement changes approved................................................................................. 1

Centers for Medicare and Medicaid Services is adopting a non-coverage position for tumor treatment field therapy.... 3

Review

Correction June 2014 PRN: Medical criteria for arthrocentesis or needling of a bursa and trigger point injections ....... 3

Policy

Place of service designation included on additional medical policies ............................................................................. 6

Policies on KRAS mutation analysis will be combined ................................................................................................... 7

Coverage criteria established for Veristrat® Assay ........................................................................................................ 8

Criteria updated for automatic external defibrillators ...................................................................................................... 9

Criteria revised for catheter ablation in the pulmonary veins .......................................................................................... 9

Criteria expanded for cardiac event detection monitoring ............................................................................................ 10

No longer paying for least costly orthosis ..................................................................................................................... 12

Coverage criteria revised for pneumatic compression devices .................................................................................... 13

Intravenous immune globulin criteria revised ............................................................................................................... 15

Duration of IV antibiotic therapy for Lyme disease is clarified ...................................................................................... 17

Clinical criteria established for Mohs Micrographic Surgery ......................................................................................... 19

Revised criteria for non-custom/custom-made gradient compression garments/stockings .......................................... 20

Invitae genetic assay coverage defined ....................................................................................................................... 21

Immune prophylaxis for Respiratory Syncytial Virus revised ........................................................................................ 21

Additional criteria added for denosumab (Prolia®,Xgeva®) ......................................................................................... 22

Additional criteria for single photon emission computed tomography added to policy ................................................. 25

Coverage criteria revised for blepharoplasty ................................................................................................................ 27

Clinical criteria established for docetaxel (Taxotere®) ................................................................................................. 29

Clinical criteria established for pemetrexed (Alimta®) .................................................................................................. 39

Clinical criteria established paclitaxel (Taxol®) ............................................................................................................ 43

Clinical criteria established for carboplatin (Paraplatin®) ............................................................................................. 57

Criteria revised for surgical treatment of varicose veins ............................................................................................... 74

Diagnosis codes revised for aqueous shunts and stents for glaucoma ........................................................................ 75

New coverage for opioid dependence therapy ............................................................................................................. 75

Elaprase® criteria updated ........................................................................................................................................... 76

Clinical criteria established for bendamustine (Treanda®) ........................................................................................... 77

Non-invasive open ventilation (NIOV) system is considered experimental/investigational ........................................... 79

Clinical criteria established for cetuximab (Erbitux®) ................................................................................................... 79

Donor leukocyte infusion approved for multiple myeloma ............................................................................................ 84

Skin allergy testing coverage criteria expanded to include eosinophilic esophagitis .................................................... 85

Electrical stimulation therapy for chronic ulcers is limited to an hour per day .............................................................. 87

Subcutaneous implantable cardioverter-defibrillator coverage defined ........................................................................ 89

Coverage criteria revised for Ilizarov bone lengthening procedure .............................................................................. 89

Criteria revised for diagnosis and treatment of obstructive sleep apnea in adults ........................................................ 90

New criteria for percutaneous ventricular assist devices ............................................................................................ 100

Hepatorenal syndrome added to indications for liver transplantation—also substance abuse criteria changed ........ 101

B-RAF DNA mutational testing (Serine/threonine-protein kinase B-RAF) considered experimental/investigational .. 101

Ozurdex™ considered medically necessary for diabetic macular edema .................................................................. 101

Medicare Advantage Policy

Clinical criteria established for denosumab (Prolia®, Xgeva®) .................................................................................. 102

Clinical criteria established for docetaxel (Taxotere®) ............................................................................................... 105

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Criteria established for Irinotecan (Camptosar®) ....................................................................................................... 116

Clinical criteria established for carboplatin (Paraplatin®) ........................................................................................... 116

New policy for palonosetron hydrochloride (Aloxi®) ................................................................................................... 133

Criteria established for paclitaxel (Taxol®) ................................................................................................................. 134

Clinical criteria established for bendamustine (Treanda®) ......................................................................................... 148

Coverage criteria established for granulocyte colony-stimulating factors ................................................................... 150

Criteria established for cetuximab (Erbitux®) ............................................................................................................. 154

Clinical criteria established for pemetrexed (Alimta®) ................................................................................................ 159

Criteria for natalizumab (Tysabri®) established ......................................................................................................... 162

Codes

New codes ................................................................................................................................................................. 165

Comments on these new medical policies? ............................................................................................................... 166

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Resource Center and sign up for electronic delivery of PRN through the e-Subscribe link.

Documents

PRN (Policy, Review & News) August 2014 · PRN 8/2014 2 nervous, radiology, urology, as well as hospital care, preventive care and newborn care visits.These changes may also affect