july 2015 policy update bulletin - oxhp7 ®oxford policy update bulletin: july 2015 oxford clinical...

UnitedHealthcare respects the expertise of the physicians, health care professionals, and their staff who participate in our network. Our goal is to

support you and your patients in making the most informed decisions regarding the choice of quality and cost-effective care, and to support practice

staff with a simple and predictable administrative experience. The Policy Update Bulletin was developed to share important information regarding

Oxford® Medical and Administrative Policy updates.*

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

July 2015

policy update bulletin Medical & Administrative Policy Updates

Oxford

Oxford

2 Oxford® Policy Update Bulletin: July 2015

Oxford® Medical and Administrative Policy Updates

Overview

Tips for using the Policy Update Bulletin:

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

directed to the corresponding policy update summary.

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

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

Policy Update Classifications

New

New clinical coverage criteria and/or documentation review requirements

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

Updated

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

to the clinical coverage criteria or documentation review requirements;

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

list(s) of applicable codes may have been updated

Revised

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

the clinical coverage criteria and/or documentation review requirements

Replaced

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

Retired

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

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

necessary and are therefore not excluded as unproven/not medically

necessary services, unless coverage guidelines or criteria are otherwise

documented in another policy

Note: The absence of a policy does not automatically indicate or imply

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

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

applicable federal or state regulatory requirements. Additionally,

UnitedHealthcare reserves the right to review the clinical evidence

supporting the safety and effectiveness of a medical technology prior to

rendering a coverage determination.

This bulletin provides complete details on Oxford® Medical and

Administrative Policy updates. The appearance of a service or

procedure in this bulletin indicates only that Oxford® has recently

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

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

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

inconsistency or conflict between the information provided in this

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

will prevail. Note that most benefit plan documents exclude from

benefit coverage health services identified as investigational or

unproven/not medically necessary. Physicians and other health

care professionals may not seek or collect payment from a

member for services not covered by the applicable benefit plan

unless first obtaining the member’s written consent,

acknowledging that the service is not covered by the benefit plan

and that they will be billed directly for the service.

A complete library of Oxford® Medical and Administrative

Policies is available at OxfordHealth.com > Providers >

Tools & Resources > Medical Information > Medical and

Administrative Policies.


Oxford


In This Issue

Clinical Policy Updates Page

NEW

Actemra® (Tocilizumab) - Effective Oct. 1, 2015 .................................................................................................................................................. 7 Eloctate™ (Antihemophilic Factor (Recombinant), FC Fusion Protein) for Connecticut Lines of Business, and New Jersey Individual Plans - Effective

Jul. 1, 2015 ..................................................................................................................................................................................................... 8 Entyvio™ (Vedolizumab) - Effective Oct. 1, 2015 .................................................................................................................................................. 9 Intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC) - Effective Aug. 1, 2015 .................................................................................. 10 Mifeprex® (Mifepristone, RU-486) - Effective Aug. 1, 2015 .................................................................................................................................. 11

UPDATED

Abortions (Therapeutic and Elective) - Effective Aug. 1, 2015 .............................................................................................................................. 12 Athletic Pubalgia Surgery - Effective Jul. 1, 2015 ................................................................................................................................................ 13 Breast Imaging for Screening and Diagnosing Cancer - Effective Jul. 1, 2015 ......................................................................................................... 13 Breast Reduction Surgery - Effective Jul. 1, 2015 ............................................................................................................................................... 16 Clinical Trials - Effective Aug. 1, 2015 ............................................................................................................................................................... 19 Corneal Hysteresis and Intraocular Pressure Measurement - Effective Aug. 1, 2015 ................................................................................................ 23 Diabetic Test Strips - Effective Aug. 1, 2015 ...................................................................................................................................................... 24 Extracorporeal Shock Wave Therapy (ESWT) - Effective Jul. 1, 2015 ..................................................................................................................... 25 Gastrointestinal Motility Disorders, Diagnosis and Treatment - Effective Jul. 1, 2015 ............................................................................................... 25 Gynecomastia - Effective Jul. 1, 2015 ............................................................................................................................................................... 27 Macular Degeneration Treatment Procedures - Effective Jul. 1, 2015 ..................................................................................................................... 29 Magnetoencephalography and Magnetic Source Imaging for Specific Neurological Applications - Effective Jul. 1, 2015 ................................................ 30 Preterm Labor: Identification and Treatment - Effective Jul. 1, 2015 ..................................................................................................................... 30 Preventive Care Services - Effective Jul. 1, 2015 ................................................................................................................................................ 31 Soliris (Eculizumab) - Effective Aug. 1, 2015 ...................................................................................................................................................... 40 Transpupillary Thermotherapy - Effective Jul. 1, 2015 ......................................................................................................................................... 42

REVISED

Drug Coverage Criteria - New and Therapeutic Equivalent Medications - Effective Aug. 1, 2015 ................................................................................ 42 Drug Coverage Guidelines - Effective Aug. 1, 2015 ............................................................................................................................................. 43

o Abilify (Aripiprazole): IM Injection ............................................................................................................................................................... 43 o Abilify (Aripiprazole): Tablet, Oral Suspension .............................................................................................................................................. 43 o Adcirca (Tadalafill) .................................................................................................................................................................................... 43 o Adempas (Riociguat) ................................................................................................................................................................................. 43 o Ampyra (Dalfampridine) ............................................................................................................................................................................ 44


Oxford


In This Issue

o Androgel (Testosterone) ............................................................................................................................................................................ 44 o Atendia 4-3% (Menthol/Lidocaine) .............................................................................................................................................................. 44 o Aubagio (Teriflunomide) ............................................................................................................................................................................ 44 o Bimatoprost 0.03% (Generic Lumigan) ........................................................................................................................................................ 44 o Dermacinrx Analgesic Kit (Diclofenac Tablet and Lidocaine, Menthol, Methyl Salicylate Patch)............................................................................. 44 o Dermacinrx Inflammatral Pak (Chlorhexidine Gluconate and Dimethicone Combination Kit) ................................................................................ 44 o Dermacinrx Silapak Kit (Triamcinolone Cream, Dimethicone Cream and Silicone Tape) ...................................................................................... 45 o Evista (Raloxifene) (Brand Only) ................................................................................................................................................................. 45 o Exjade (Deferasirox) ................................................................................................................................................................................. 45 o Extavia (Interferon B-1b) ........................................................................................................................................................................... 45 o Ferriprox (Deferiprone) .............................................................................................................................................................................. 45 o Flector (Diclofenac) ................................................................................................................................................................................... 45 o Genotropin (Somatropin) ........................................................................................................................................................................... 45 o Gilenya (Fingolimod) ................................................................................................................................................................................. 46 o Grastek (Timothy Grass Pollen Allergen Extract) ........................................................................................................................................... 46 o Hemophilia Drugs ..................................................................................................................................................................................... 46 o Hetlioz (Tasimelteon) ............................................................................................................................................................................... 46 o Humatrope (Somatropin) ........................................................................................................................................................................... 46 o Increlex (Mecasermin) ............................................................................................................................................................................... 47 o Infergen, (Interferon Alfacon-1) .................................................................................................................................................................. 47 o Intron-A (Interferon Alfa-2b) ...................................................................................................................................................................... 47 o Irenka (Duloxetine) ................................................................................................................................................................................... 48 o Jakafi (Ruxolitinib) .................................................................................................................................................................................... 48 o Letairis (Ambrisentan) ............................................................................................................................................................................... 48 o Lotronex (Alosetron) ................................................................................................................................................................................. 49 o Mekinist (Trametinib) ................................................................................................................................................................................ 49 o Mifeprex (Mifepristone) .............................................................................................................................................................................. 49 o Norditropin AQ (Somatropin) ...................................................................................................................................................................... 49 o Norditropin (Somatropin) ........................................................................................................................................................................... 50 o Norditropin Nordiflex (Somatropin).............................................................................................................................................................. 50 o Nuspin (Somatropin) ................................................................................................................................................................................. 51 o Nutropin and Nutropin AQ (Somatropin) ...................................................................................................................................................... 51 o Omnitrope (Somatropin) ............................................................................................................................................................................ 52 o Opsumit (Macitentan) ................................................................................................................................................................................ 53 o Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) ................................................ 53 o Orenitram (Treprostinil) ............................................................................................................................................................................. 53 o Pegasys (Peginterferon Alfa-2a) .................................................................................................................................................................. 54 o Peg-Intron (Peginterferon Alfa-2b) .............................................................................................................................................................. 55 o Pomalyst (Pomalidomide) ........................................................................................................................................................................... 56 o Ragwitek (Short Ragweed Pollen Allergen Extract) ........................................................................................................................................ 56


Oxford


In This Issue

o Rebif (Interferon Beta-1a) .......................................................................................................................................................................... 56 o Renovo Lido 5 (Lidocaine/Menthol/Capsaicin) ............................................................................................................................................... 57 o Repository Corticotropin Injection (H.P.Acthar Gel): Injection By A Medical Professional .................................................................................... 57 o Revatio (Sildenafil Citrate) ......................................................................................................................................................................... 57 o Revatio (Sildenafil Citrate) 10mg/ml ............................................................................................................................................................ 57 o Revlimid (Lenalidomide) ............................................................................................................................................................................ 58 o Saizen (Somatropin) ................................................................................................................................................................................. 59 o Serostim (Somatropin) .............................................................................................................................................................................. 60 o Sildenafil Citrate (Generic Revatio) .............................................................................................................................................................. 60 o Sirturo (Bedaquiline) ................................................................................................................................................................................. 61 o Soltamox (Tamoxifen Citrate) ..................................................................................................................................................................... 61 o Stiolto Respimat (Olodaterol/Tiotropium) ..................................................................................................................................................... 61 o Sylatron (Peginterferon Alfa-2b) ................................................................................................................................................................. 61 o Synarel (Nafarelin Acetate) ........................................................................................................................................................................ 61 o Tafinlar (Dabrafenib) ................................................................................................................................................................................. 61 o Tamoxifen ................................................................................................................................................................................................ 62 o Tev-Tropin (Somatropin)............................................................................................................................................................................ 62 o Thalomid (Thalidomide): Oral ..................................................................................................................................................................... 62 o Tracleer (Bosentan) ................................................................................................................................................................................... 63 o Tyvaso (Treprostinil) ................................................................................................................................................................................ 63 o Urevaz 44% Cream (Urea) ......................................................................................................................................................................... 64 o Vecamyl (Mecamylamine) .......................................................................................................................................................................... 64 o Ventavis (Iloprost) .................................................................................................................................................................................... 64 o Zelboraf (Vemurafenib) ............................................................................................................................................................................. 64 o Zomacton (Somatropin) ............................................................................................................................................................................. 65 o Zorbtive (Somatropin) ............................................................................................................................................................................... 65

Omnibus Codes - Effective Aug. 1, 2015 ............................................................................................................................................................ 65 Repository Corticotropin Injection (H.P. Acthar Gel) - Effective Aug. 1, 2015.......................................................................................................... 66 Rhinoplasty and Other Nasal Surgeries - Effective Aug. 1, 2015 ........................................................................................................................... 67 Sodium Hyaluronate - Effective Aug. 1, 2015 ..................................................................................................................................................... 70 Specialty Medication Administration - Site of Care Review Guidelines - Effective Oct. 1, 2015 .................................................................................. 73 Tysabri (Natalizumab) - Effective Aug. 1, 2015 .................................................................................................................................................. 74 Xolair (Omalizumab) - Effective Aug. 1, 2015 ..................................................................................................................................................... 76

REPLACED

Cardiology Procedures Requiring Precertification - Effective Jul. 1, 2015 ................................................................................................................ 79 Connecticut Clinical Trials - Effective Aug. 1, 2015 .............................................................................................................................................. 79 Radiation Therapy Procedures Requiring Precertification - Effective Jul. 1, 2015 ..................................................................................................... 79


Oxford


In This Issue

Radiology Procedures Requiring Precertification - Effective Jul. 1, 2015 ................................................................................................................. 80

Administrative Policy Updates

NEW

New York Participating Provider Laboratory & Pathology Protocol - Effective Sep. 1, 2015 ........................................................................................ 81

UPDATED

Autism - Effective Aug. 1, 2015 ........................................................................................................................................................................ 83

RETIRED

Laboratory Services Protocol - Effective Jul. 1, 2015 ........................................................................................................................................... 84

Reimbursement Policy Updates

UPDATED

Bilateral Procedures Policy - Effective Jul. 1, 2015 .............................................................................................................................................. 85 Care Plan Oversight Policy - Effective Jul. 1, 2015 .............................................................................................................................................. 88 Co-Surgeons; Team Surgeon Policy - Effective Jul. 1, 2015.................................................................................................................................. 88 New Patient Visit Policy - Effective Jul. 1, 2015................................................................................................................................................... 90 Split Surgical Package Policy - Effective Jul. 1, 2015 ........................................................................................................................................... 91


Oxford

Clinical Policy Updates

NEW

Policy Title Effective Date Coverage Rationale

Actemra® (Tocilizumab)

Oct. 1, 2015 Tocilizumab is proven for the treatment of: 1. Rheumatoid arthritis

Tocilizumab is proven and medically necessary for the treatment of rheumatoid arthritis when all of the following criteria are met:

A. Moderate to severe disease activity (e.g., swollen, tender joints with limited range of motion); and

B. History of failure, contraindication, or intolerance to one non-biologic disease modifying anti-rheumatic drugs (DMARDs) [e.g., methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, minocycline, etc.]; and

C. Patient is not receiving tocilizumab in combination with either of the following:

1. Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi

(golimumab)] 2. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]

2. Systemic juvenile idiopathic arthritis (SJIA)

Additional information to support medical necessity review: Tocilizumab is medically necessary for the treatment of systemic juvenile idiopathic arthritis when all of the

following criteria are met:

A. Active disease (e.g., fever, serositis, rash, arthritis); and

B. Patient is not receiving tocilizumab in combination with either of the following:

1. Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]

2. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)] and

C. History of failure, contraindication, or intolerance to one of the following:

1. Non-steroidal anti-inflammatory drug (NSAID) 2. Systemic glucocorticoid

3. Polyarticular juvenile idiopathic arthritis (PJIA)

Additional information to support medical necessity review:

Tocilizumab is medically necessary for the treatment of polyarticular juvenile idiopathic arthritis when all of the

following criteria are met:

A. Active disease (e.g., swollen, tender joints with limited range of motion); and

B. History of failure, contraindication, or intolerance to at least one non-biologic disease modifying anti-rheumatic drugs (DMARDs) [e.g., methotrexate, leflunomide, sulfasalazine, etc.]; and

C. Patient is not receiving tocilizumab in combination with either of the following:

1. Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi

(golimumab)] 2. Janus kinase inhibitor [e.g., Xeljanz (tofacitinib)]


Oxford


NEW


Eloctate™ (Antihemophilic Factor (Recombinant), FC Fusion Protein) for

Connecticut Lines

of Business, and New Jersey Individual Plans

Jul. 1, 2015

Eloctate™ (antihemophilic factor (recombinant), Fc fusion protein) Antihemophilic Factor (recombinant), FC Fusion Protein [Eloctate] is proven when used according to FDA labeled indications. All of the following criteria must be met: Diagnosis of hemophilia A; and

One of the following:

o Treatment of bleeding episodes; or o Prevention of bleeding episodes (prophylaxis); or o Prevention of bleeding in surgical interventions or invasive procedures (e.g., surgical prophylaxis);

and

Prescribed dosage and interval utilized is within range as defined by the prescribing information

Additional information to support medical necessity review: Antihemophilic Factor (recombinant), FC Fusion Protein [Eloctate] is medically necessary for the treatment of Hemophilia A when one of the following criteria is met:

All of the following:

Diagnosis of severe hemophilia A; and Documentation of endogenous factor VIII levels less than 2% of normal factor VIII (< 0.02 IU/ml); and Patient is not a suitable candidate for treatment with shorter half-life Factor VIII (recombinant) products [Advate,

Helixate FS, Kogenate FS, Novoeight, Recombinate, or Xyntha, Xyntha Solofuse] as attested by the prescribing

physician; and One of the following:

o Treatment of bleeding episodes o Prevention of bleeding in surgical interventions or invasive procedures (e.g., surgical prophylaxis) o Prevention of bleeding episodes (i.e., routine prophylaxis)

and

Documentation of both of the following:

o Dose does not exceed 50 IU/kg o Infusing no more frequently than every 4 days

OR

All of the following:

One of the following: o Both of the following:

i. Moderate hemophilia A ii. Endogenous factor VIII level 2% < 5% (0.02 IU/ml to less than 5 IU/ml)

or


Oxford


NEW


Eloctate™ (Antihemophilic Factor (Recombinant), FC Fusion Protein) for

Connecticut Lines

of Business, and New Jersey Individual Plans (continued)

Jul. 1, 2015

o Both of the following: i. Mild hemophilia A ii. Endogenous factor VIII level > 5% (greater than 0.05 IU/ml)

and

Patient is not a suitable candidate for treatment with shorter half-life Factor VIII (recombinant) products

[Advate, Helixate FS, Kogenate FS, Novoeight, Recombinate, or Xyntha, Xyntha Solofuse] as attested by the prescribing physician; and

One of the following: o Treatment of bleeding episodes o Prevention of bleeding in surgical interventions or invasive procedures (e.g., surgical prophylaxis)

o Prevention of bleeding episodes (i.e., routine prophylaxis) with documentation of one of the following in an 8 week period: i. ≥1 or more episodes of spontaneous/ traumatic bleeding into joint ii. ≥1 episode of spontaneous / traumatic bleeding into the central nervous system iii. ≥1 episode of severe soft tissue bleeding (i.e., ileopsoas)

and

Documentation of both of the following:

o Dose does not exceed 50 IU/kg o Infusing no more frequently than every 4 days

Eloctate requires precertification with review by a medical director or their designee.

Entyvio™ (Vedolizumab)

Oct. 1, 2015

1. Vedolizumab is proven and medically necessary for the treatment of ulcerative colitis (UC) when all of the following criteria are met: A. Moderate to severe disease activity ulcerative colitis (e.g., esophageal, gastroduodenal, perianal, or rectal

disease; history of colonic or small-bowel resection); and B. One of the following:

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

ii. Immunomodulator (e.g., azathioprine, 6-mercaptopurine) iii. Corticosteroid

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

and

C. Patient is not receiving vedolizumab in combination with either of the following: 1) Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Simponi (golimumab)] 2) Tysabri (natalizumab)


Oxford


NEW


Entyvio™ (Vedolizumab) (continued)

Oct. 1, 2015 2. Vedolizumab is proven and medically necessary for the treatment of active Crohn's disease (CD) when all of the following criteria are met: A. Moderate to severe disease activity Crohn’s disease (e.g., esophageal, gastroduodenal, perianal, or rectal

disease; history of colonic or small-bowel resection); and B. One of the following:

1) History of failure, contraindication, or intolerance to at least one of the following conventional therapies:

i. Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Cimzia (certolizumab)] ii. Immunomodulator (e.g., azathioprine, 6-mercaptopurine) iii. Corticosteroid

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

and

C. Patient is not receiving vedolizumab in combination with either of the following: 1) Tumor necrosis factor (TNF) blocker [e.g., Humira (adalimumab), Cimzia (certolizumab)]

2) Tysabri (natalizumab)

Intraoperative Hyperthermic

Intraperitoneal Chemotherapy

(HIPEC)

Aug. 1, 2015 Note: This medical policy does not apply to normothermic (no hyperthermia is used) postoperative intraperitoneal chemotherapy, delivered via an indwelling port or catheter, used to treat ovarian cancer.

When performed in conjunction with cytoreductive surgery (CRS), intraoperative hyperthermic

intraperitoneal chemotherapy (HIPEC) is proven and medically necessary for treating the following conditions: Peritoneal mesothelioma Pseudomyxoma peritonei (PMP) resulting from a mucus-producing tumor Intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) is unproven and not medically necessary for all other indications including, but not limited to, peritoneal carcinomatosis resulting from

the following cancers: Colorectal Gastric

Ovarian Clinical evidence demonstrating the safety and efficacy of intraoperative HIPEC to treat conditions other than those

listed above as proven is insufficient at this time. Further prospective studies comparing this treatment option to standard treatment protocols are needed to determine impact on survival and to identify patient selection criteria and effective chemotherapy regimens. However, depending on the enrollee-specific benefit document, coverage may be available through participation in an eligible clinical trial.


Oxford


NEW


Mifeprex® (Mifepristone, RU-486)

Aug. 1, 2015

Mifepristone is proven and medically necessary for termination of pregnancy through 63 days gestation when administered under the supervision of a qualified physician. For purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 day cycle with ovulation occurring at mid-cycle.

Mifeprex should be prescribed only by physicians who have read and understood the prescribing information. Mifeprex may be administered only in a clinic, medical office, or hospital, by or under the supervision of a

physician, able to assess the gestational age of an embryo and to diagnose ectopic pregnancies. Physicians must also be able to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and be able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

Mifepristone is unproven and not medically necessary for treatment of: 1. Leiomyomata

2. Endometriosis 3. Breast cancer 4. Ovarian cancer 5. Meningioma 6. Psychotic major depression

7. Oral contraception 8. Induction of labor

Recommended Guidelines Therapeutic Abortions Coverage of therapeutic abortions is subject to benefit availability and any specific limitations/maximums as outlined in the Member's certificate of coverage/health benefits plan.

Oxford covers therapeutic abortions that may include the following indications: Medical conditions which cause pregnancy to pose substantial risk to maternal health such as cardiac or

cardiovascular anomalies, cardiovascular disease, renal disease, malignancy, and severe diabetes mellitus

The certain diagnosis of: o Chromosomal abnormalities inconsistent with normal life in the fetus o Major structural defects such as severe neural tube defects, severe cardiac abnormalities, severe ventral wall

defects, or other severe structural defects o Major metabolic abnormalities such as sickle cell disease, Tay Sachs disease, cystic fibrosis, or major

biochemical abnormalities Pregnancy which is the result of rape or incest Exposure to known teratogenic agents, which pose significant risk of fetal developmental abnormalities


Oxford


NEW


Mifeprex® (Mifepristone, RU-486) (continued)

Aug. 1, 2015 Elective Abortions Coverage of elective abortions is subject to benefit availability and any specific limitations/maximums as outlined in the Member's certificate of coverage/health benefits plan. Note:

Treatment of complications of elective and therapeutic abortions is considered medically necessary and therefore

not subject to annual and dollar limits. If an abortion CPT code is billed, it is reimbursed according to the elective abortion benefit, unless the diagnosis

code is listed as a "Therapeutic ICD-9 Diagnosis Code" in Payment Guidelines below.

UPDATED

Policy Title Effective Date Summary of Changes Coverage Rationale

Abortions (Therapeutic and Elective)

Aug. 1, 2015

Removed content/language and HCPCS codes specific to Mifeprex (Mifepristone); added reference link to new policy titled

Mifeprex® (Mifepristone, RU-486)

for applicable coverage guidelines

Recommended Guidelines

Therapeutic Abortions Coverage of therapeutic abortions is subject to benefit availability and any

specific limitations/maximums as outlined in the Member's certificate of coverage/health benefits plan.

Oxford covers therapeutic abortions that may include the following indications: Medical conditions which cause pregnancy to pose substantial risk to

maternal health such as cardiac or cardiovascular anomalies, cardiovascular disease, renal disease, malignancy, and severe diabetes mellitus

The certain diagnosis of: o Chromosomal abnormalities inconsistent with normal life in the fetus o Major structural defects such as severe neural tube defects, severe

cardiac abnormalities, severe ventral wall defects, or other severe

structural defects o Major metabolic abnormalities such as sickle cell disease, Tay Sachs

disease, cystic fibrosis, or major biochemical abnormalities Pregnancy which is the result of rape or incest Exposure to known teratogenic agents, which pose significant risk of fetal

developmental abnormalities

Elective Abortions Coverage of elective abortions is subject to benefit availability and any specific limitations/maximums as outlined in the Member's certificate of


Oxford


UPDATED


Abortions (Therapeutic and Elective) (continued)

Aug. 1, 2015 coverage/health benefits plan. Note: Treatment of complications of elective and therapeutic abortions is

considered medically necessary and therefore not subject to annual and

dollar limits.

If an abortion CPT code is billed, it is reimbursed according to the elective abortion benefit, unless the diagnosis code is listed as a "Therapeutic ICD-9 Diagnosis Code" in Payment Guidelines below.

Athletic Pubalgia Surgery

Jul. 1, 2015 Updated supporting information to reflect the most current clinical evidence and references; no

change to coverage rationale or list of applicable codes

Surgical repair for treating athletic pubalgia is unproven and not medically necessary.

Several studies have shown that groin pain and function are improved after surgical repair for athletic pubalgia. However, most of these studies were uncontrolled, used small sample sizes, and did not provide comparisons of the surgical methods used to treat athletic pubalgia. Large prospective randomized studies of individuals with athletic pubalgia with more detailed

patient outcome measurements are needed to determine optimal treatment.

Breast Imaging for Screening and Diagnosing Cancer

Jul. 1, 2015

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

Important Note: Oxford has engaged CareCore National to perform initial reviews of requests for pre-certification and Medical necessity reviews (Oxford continues to be responsible for decisions to limit or deny coverage and for appeals). All pre-certification requests are handled by CareCore National. To pre-certify a radiology procedure, please call CareCore National at 1-877-PRE-AUTH (1-

877-773-2884) or log onto the CareCore web page at www.carecorenational.com.

CareCore has established an infrastructure to support the review, development, and implementation of comprehensive outpatient imaging criteria. The radiology evidence-based guidelines and management criteria

are available on the CareCore National web site: http://www.carecorenational.com. Please refer to Radiology Procedures Requiring Precertification for CareCore National Arrangement for applicable CPT/HCPCS codes and additional requirements, if applicable.


Oxford


UPDATED


Breast Imaging for Screening and Diagnosing Cancer (continued)

Jul. 1, 2015

Breast Imaging as an Adjunct to Mammography Digital mammography is medically necessary for patients with dense breast tissue. Breast Magnetic Resonance Imaging (MRI)

Breast magnetic resonance imaging (MRI) is medically necessary for

patients at high risk for breast cancer as defined as having any of the following: Personal history of atypical breast histologies Family history or genetic predisposition for breast cancer Prior therapeutic thoracic radiation therapy Dense breast tissue with any one of the following risk factors:

o Lifetime risk of breast cancer of ≥20%, according to risk assessment tools based on family history

o Personal history of BRCA1 or BRCA 2 gene mutations o First-degree relative with a BRCA 1 or BRCA 2 gene mutation but no

having had genetic testing themselves o Prior therapeutic thoracic radiation therapy between ages of 10-30

o Personal history of Li Fraumeni Syndrome, Cowden syndrome or

Bannayan-Riley-Ruvalcaba syndrome or a first-degree relative with one of these syndromes.

Breast magnetic resonance imaging (MRI) is not medically necessary for patients with dense breast tissue not accompanied by defined risk factors as described above.

Digital Breast Tomosynthesis (3-D Mammography) Digital tomosynthesis is not medically necessary for the screening and diagnosis of breast cancer.

There is insufficient evidence to conclude that digital tomosynthesis of the breast is effective for the screening or diagnosis of breast cancer. Clinical

evidence has not yet demonstrated that digital breast tomosynthesis used as an adjunct to standard mammography reduces the mortality rate from breast cancer. Magnetic Resonance Elastography of the Breast Magnetic resonance elastography (MRE) is not medically necessary for breast cancer screening or diagnosis.


Oxford


UPDATED



Jul. 1, 2015

There is insufficient evidence to conclude that MRE of the breast is effective for the screening or diagnosis of breast cancer. While data from small feasibility studies indicate that MRE may have some ability to discriminate

between cancerous tissue and normal breast tissue or benign lesions based on tissue stiffness, there was overlap in values, and the diagnostic accuracy

of MRE for detection of breast cancer remains to be determined. There are no definitive patient selection criteria for MRE for breast cancer detection. Breast Specific Gamma Imaging (Scintimammography) Scintimammography is not medically necessary for breast cancer

screening or diagnosis. There is insufficient evidence that this diagnostic modality can differentiate benign from malignant breast lesions. Based on the evidence, the role of scintimammography remains unclear since this technology has not been shown to be accurate enough to screen for breast cancer or allow a confident decision to defer biopsy. Electrical Impedance Scanning (EIS)

Electrical impedance scanning (EIS) is not medically necessary for the detection of breast cancer. There is insufficient evidence that EIS is effective in detecting malignant breast tissue. Evaluation of sensitivity and negative predictive value for EIS is inconsistent. Well-designed studies are needed to determine whether or

not EIS is effective as an adjunct to mammography or provides a positive clinical benefit. Computer Aided Detection for MRI of the Breast Computer-aided detection (CAD) is not medically necessary as an aid for radiologists to interpret contrast-enhanced magnetic resonance imaging

(MRI) of the breast.

Clinical evidence has not yet demonstrated that CAD improves patient outcomes or reduces breast cancer mortality when added to contrast-enhanced MRI. There is insufficient evidence to assess whether the use of CAD systems would maintain or increase the sensitivity, specificity, and recall rates of MRI of the breast. Prospective, well-designed and executed studies are needed to determine whether or not the use of CAD provides a positive

clinical benefit.


Oxford


UPDATED



Jul. 1, 2015 Breast Ultrasound Breast ultrasound is not medically necessary for routine breast cancer screening including patients with dense breast tissue. Clinical evidence has not yet demonstrated that routine use of ultrasonography as an adjunct to screening mammography reduces the mortality rate from breast cancer.

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

breast lesions and in guiding placement of instruments for cyst aspiration and percutaneous breast biopsies. Computer Aided Detection for Ultrasound Computer-aided detection (CAD) is not medically necessary as an aid for radiologists to detect breast cancer during ultrasound.

Clinical evidence has not yet demonstrated that CAD improves patient outcomes or reduces breast cancer mortality when added to ultrasonography. Future research should include better-designed studies, including prospective studies and randomized controlled trials evaluating this technology in large numbers of screening ultrasounds.

Automated Breast Ultrasound

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

Refer to the CareCore Evidence Based Imaging Guidelines - Oxford for: Magnetic resonance imaging (MRI) of the breast

3D rendering of computed tomography, magnetic resonance imaging or

other tomographic modalities

Breast Reduction Surgery

Jul. 1, 2015

Routine review; no change to

coverage rationale or lists of applicable codes

Indications for Coverage

Criteria for a Coverage Determination as Reconstructive: Breast reduction surgery is considered reconstructive and medically necessary when the following criteria are met: A. Macromastia is the primary etiology of the member’s functional

impairment or impairments (as defined in the Definitions section);


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Breast Reduction Surgery (continued)

Jul. 1, 2015

The following are examples of functional impairments that must be attributable to macromastia to be considered (not an all-inclusive list): o Severe skin excoriation/intertrigo unresponsive to medical

management o Severe restriction of physical activities that meets the definition of

functional impairment below

o Signs and symptoms of nerve compression that are unresponsive to medical management, e.g. ulnar paresthesias

o Acquired kyphosis that is attributed to macromastia o Chronic breast pain due to weight of the breasts o Upper back, neck, or shoulder pain o Shoulder grooving from bra straps

o Headache and B. The amount of tissue to be removed plots above the 22nd percentile; or C. If the amount of tissue to be removed plots between the 5th and 22nd

percentiles, the procedure may be either reconstructive or cosmetic; the determination is based on the review of the information provided; and

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

impairment; and E. The proposed procedure is likely to result in significant improvement of

the functional impairment.

The following documentation may be requested as part of the review Reduction Mammoplasty documentation should include the evaluation and

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

Body Surface Area (BSA). Photographs that document macromastia.

Coverage Limitations and Exclusions

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

anomalies in the absence of a functional impairment. Please refer to member specific benefit documents. 1. Cosmetic Procedures are excluded from coverage. Procedures that


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Jul. 1, 2015

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

such consequences or behavior) as a reconstructive procedure.

2. Any procedure that does not meet the reconstructive criteria above in the Indications for Coverage section, e.g. psychological or social reasons, breast size asymmetry unless post mastectomy, exercise.

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

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

is considered cosmetic. Appendix

This Schnur chart may be used to assess whether the amount of tissue that

will be removed is reasonable for the body habitus, and whether the

procedure is cosmetic or reconstructive in nature. 1. If the amount plots above the 22nd percentile and the member has a

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

may be either reconstructive or cosmetic based on review of information.

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

in centimeters)

Modified Schnur Nomogram Chart

Tissue removed per breast (gm)

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

1.35 127 199

1.40 139 218

1.45 152 238

1.50 166 260

1.55 181 284


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Jul. 1, 2015 1.60 198 310

1.65 216 338

1.70 236 370

1.75 258 404

1.80 282 441

1.85 308 482

1.90 336 527

1.95 367 575

2.00 401 628

2.05 439 687

2.10 479 750

2.15 523 819

2.20 572 895

2.25 625 978

2.30 682 1,068

2.35 745 1,167

2.40 814 1,275

2.45 890 1,393

2.50 972 1,522

2.55 1,062 1,662

Clinical Trials

Aug. 1, 2015

Reorganized policy guidelines; added content/language specific

to Connecticut (CT) plan members previously outlined in policy titled Connecticut Clinical Trials

Updated reference links to related policies: o Added reference link to policy

titled

Experimental/Investigational Treatment for NJ Plans

o Removed reference link to policy titled Connecticut Clinical Trials (retired 08/01/14)

Updated benefit considerations: o Added guidelines for in-network

exceptions (previously located

Effective for plan years starting on or after January 1, 2014, the Patient Protection and Affordable Care Act (“PPACA”) requires non-grandfathered

health plans to cover “Routine Patient Costs” incurred by a “Qualifying Individual” who is participating in an “Approved Clinical Trial”. Benefits include the reasonable and necessary items and services used to prevent, diagnose and treat complications arising from participation in a qualifying clinical trial.

Benefits are available only when the Member is clinically eligible for participation in the qualifying clinical trial as defined by the researcher. I. APPROVED CLINICAL TRIAL A. An “Approved Clinical Trial” is defined as:

o Phase I, Phase II, Phase III, or Phase IV clinical trial,

o Being conducted in relation to the prevention, detection or treatment


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Clinical Trials (continued)

Aug. 1, 2015

in the Coverage Rationale section of the policy)

o Added product specific information for Connecticut (CT) plan members

o Added language for Essential

Health Benefits for Individual and Small Group plans to indicate: For plan years beginning on

or after January 1, 2014, the Affordable Care Act of

2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories

of Essential Health Benefits

(“EHBs”) Large group plans (both

self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer

coverage for EHBs; however, if such plans choose to provide coverage for benefits which are

deemed EHBs (such as maternity benefits), the ACA requires all dollar

limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans

The determination of which benefits constitute EHBs is made on a state by state

for Cancer or other life threatening disease or condition, and o That meets the requirements under Section II below. For purposes of this benefit, a “life-threatening disease or condition” is one from which the likelihood of death is probable unless the course of the disease or condition is interrupted.

B. Additional Clinical Trials The following clinical trials are not currently required by PPACA. However, these clinical trials are covered under Oxford’s clinical trial benefit. o Phase I, Phase II or Phase III clinical trial, o Being conducted in relation to the detection or treatment of non-life

threatening:

Cardiovascular disease (cardiac/stroke), Surgical musculoskeletal disorders of the spine, hip and knees,

and/or Other Clinical Trials: Certain plans may allow clinical trials relating

to other diseases or disorders which are not life-threatening. Please refer to the enrollee’s plan-specific SPD for coverage

That meets the requirements under Section II below.

II. CRITERIA FOR APPROVED CLINICAL TRIALS A. The clinical trial must be described in paragraph 1, 2 or 3 below.

1. The study or investigation is approved or funded (which may include funding through in-kind contributions) by one or more of the following: National Institutes of Health (NIH). (Includes National Cancer

Institute (NCI).) Centers for Disease Control and Prevention (CDC). Agency for Healthcare Research and Quality (AHRQ). Centers for Medicare and Medicaid Services (CMS).

A cooperative group or center of any of the entities described above or the Department of Defense (DOD) or the Veterans Administration (VA).

A qualified non-governmental research entity identified in the guidelines issued by the National Institutes of Health for center support grants.

The Department of Veterans Affairs, the Department of Defense or the Department of Energy as long as the study or investigation has been reviewed and approved through a system of peer review that is determined by the Secretary of Health and Human Services to


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Aug. 1, 2015

basis; as such, when using this guideline, it is important to refer to the member specific benefit document to determine

benefit coverage

Updated coverage rationale: o Reformatted Criteria for

Approved Clinical Trials; removed sub-header for “Federally Funded Trials”

o Modified language pertaining to

Routine Patient Costs During Clinical Trials: Replaced references to

“investigational item or service” with “experimental or investigational service or

item”

Replaced sub-header “Benefits for Clinical Trials Do Not Include” with “Coverage Limitations and Exclusions”

- Updated list of

applicable coverage limitations and

exclusions; added language to clarify

benefit coverage is not provided for clinical trials that do not meet the requirements (an

example includes, but is not limited to, Phase 0 drug clinical trials)

o Removed coverage guidelines for plan years prior to 01/01/2014

meet both of the following criteria:

- Comparable to the system of peer review of studies and

investigations used by the National Institutes of Health.

- Ensures unbiased review of the highest scientific standards by

qualified individuals who have no interest in the outcome of the review.

or 2. The study or investigation is conducted under an investigational new

drug application reviewed by the U.S. Food and Drug Administration; or

3. The study or investigation is a drug trial that is exempt from having such an investigational new drug application.

B. Additional Requirements

1. The clinical trial must have a written protocol that describes a

scientifically sound study and have been approved by all relevant institutional review boards (IRBs) before participants are enrolled in

the trial. We may, at any time, request documentation about the trial. 2. The subject or purpose of the trial must be the evaluation of an item or

service that meets the definition of a Covered Health Service and is not otherwise excluded under the Policy.

III.QUALIFIED INDIVIDUAL A. To be a qualified individual an individual must be:

1. Covered under the health plan, and 2. Eligible to participate in an approved clinical trial according to the trial

protocol based upon: The individual was referred to the clinical trial by an in-network

health care professional who has concluded that the individual's

participation would be appropriate because the individual is eligible for the trial according to its protocol, or

The individual provides the plan with medical and scientific information that establishes that participation would be appropriate because the individual is eligible for the trial according to its protocol.

IV. ROUTINE PATIENT COSTS DURING CLINICAL TRIALS INCLUDE: A. Covered Health Services for which Benefits are typically provided absent a

clinical trial.


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Aug. 1, 2015

Updated definitions: o Removed definition of

“investigational device exemption (IDE)” and “clinical trial phases (medical)” (applied

to plan years prior to

01/01/2014) o Added definition of “covered

health services” (applies to all products)

o Added CT product specific definition of “approved clinical

trial” and “experimental or investigational service(s)”

B. Covered Health Services required solely for: 1. The provision of the Experimental or Investigational service(s) or item

(e.g. the infusion administration services to deliver an investigational drug), and/or

2. The clinically appropriate monitoring of the effects of the service or

item (e.g. lab tests and imaging done at a frequency consistent with

signs and symptoms and other standards of care for that diagnosis or treatment type), and/or

3. The prevention of complications. C. Covered Health Services needed for reasonable and necessary care

arising from the provision of an Experimental or Investigational service(s)

item.

Network Plans: If one or more network providers are participating in a clinical trial, then Oxford may require that the Qualified Individual participate in the clinical trial using a network provider, as long as the network provider will accept

the qualifying individual as a participant in the trial. However, if an Approved

Clinical Trial is conducted outside of the Qualified Individual’s state of residence, then Oxford may not deny or otherwise limit payment for Routine Patient Services solely on the basis that the trial is conducted out-of-state. COVERAGE LIMITATIONS AND EXCLUSIONS: A. The Experimental or Investigational Service(s) or item that is used in the

clinical trial is not covered, except for the following: 1. Certain Category B devices (see definition below) 2. Certain promising interventions for patients with terminal illnesses. 3. Other items and services that, in our determination, meet specified

criteria in accordance with our medical and drug policies. B. Items and services provided solely to satisfy data collection and analysis

needs and that are not used in the direct clinical management of the

patient. Examples include, but are not limited to: o Laboratory tests and imaging studies done at a frequency dictated by

the study protocol and not consistent with signs and symptoms and other standards of care for that diagnosis or treatment type.

C. A service that is clearly inconsistent with widely accepted and established standards of care for a particular diagnosis.

D. Items and services provided by the research sponsors free of charge for


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Aug. 1, 2015 any person enrolled in the trial. E. Travel and transportation expenses are excluded from coverage. These

include, but are not limited to, the following examples: 1. Fees for all types of transportation. Examples include, but are not

limited to: personal vehicle, taxi, medical van, ambulance, commercial

airline, and train.

2. Rental car expenses. 3. Mileage reimbursement for driving a personal vehicle. 4. Lodging. 5. Meals.

F. Routine patient costs obtained out-of-network where non-network benefits do not exist under the plan.

G. Clinical Trials that do not meet the requirements listed in the Indications for Coverage section above. An example includes, but is not limited to, Phase 0 drug clinical trials.

Corneal Hysteresis and Intraocular

Pressure Measurement

Aug. 1, 2015

Updated list of applicable CPT codes: added 67299 and 66999

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

Measurement of corneal hysteresis is unproven and not medically necessary for the diagnosis and management of corneal disorders

and glaucoma: There is insufficient evidence to evaluate corneal hysteresis measurement for the purpose of assessing corneal viscoelasticity. Studies do not demonstrate that the measurement of corneal hysteresis impacts health outcomes such as improving vision or increasing the detection of ocular disorders. Further investigation that demonstrates the clinical usefulness of this procedure is necessary before it can be considered medically necessary.

Measurement of ocular blood flow by intraocular pressure sampling using an ocular blood flow tonometer is unproven and not medically necessary for the diagnosis and management of glaucoma and other ocular disorders: There is insufficient evidence to evaluate ocular blood flow measurement. Studies do not demonstrate

that the measurement of ocular blood flow improves health outcomes such as improving vision or increasing the detection of glaucoma and

other ocular disorders. Further clinical trials demonstrating the clinical usefulness of this procedure are necessary before it can be considered medically necessary.

Monitoring of intraocular pressure during vitrectomy is unproven and not medically necessary: There is insufficient evidence to indicate that intraocular pressure improves health outcomes such as visual acuity

recovery in patients who undergo vitrectomy. Additional clinical trials are


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Corneal Hysteresis and Intraocular Pressure Measurement (continued)

Aug. 1, 2015 required to determine if monitoring of intraocular pressure during vitrectomy accurately measures intraocular pressure and if it improves visual acuity recovery after vitrectomy.

Continuous monitoring of intraocular pressure for 24 hours or longer in patients with glaucoma is unproven and not medically

necessary: There is insufficient evidence to conclude that continuous

monitoring of intraocular pressure improves health outcomes in patients with glaucoma. Further studies are needed to evaluate the long-term safety and tolerability of continuous monitoring of intraocular pressure before it can be implemented in clinical practice.

Diabetic Test

Strips

Aug. 1, 2015

Routine review; no change to

coverage rationale or lists of applicable codes

Oxford will cover Tier 3 Test Strips* or Blood Glucose Meters as indicated

below.

A. Tier 3 Test Strips* or Blood Glucose Meters (Ascensia, Precision) will be approved based on the following criterion: 1. History of at least a two week trial of all of the following:

a) Accu-Chek Nano (Accu-Chek Smartview test strips)*

b) Accu-Chek Aviva (Accu-Chek Aviva Plus test strips)* c) One Touch Ultra (One Touch Ultra test strips)* d) One Touch Verio IQ (One Touch Verio IQ test strips)*

B. Tier 3 Test Strips* or Blood Glucose Meter Freestyle will be approved based on the following criteria: 1. History of at least a two week trial of all of the following:

a) Accu-Chek Nano (Accu-Chek Smartview test strips)*

b) Accu-Chek Aviva (Accu-Chek Aviva Plus test strips)* c) One Touch Ultra (One touch Ultra test strips)* d) One Touch Verio IQ (One Touch Verio test strips)*

OR 2. Member is currently established on an OmniPod insulin pump or

another insulin pump that communicates wirelessly with a meter that requires Freestyle test strips.

C. Tier 3 Test Strips* or Blood Glucose Meter Contour will be approved based on the following criteria:

1. History of at least a two week trial of all of the following: a) Accu-Chek Nano (Accu-Chek Smartview test strips)* b) Accu-Chek Aviva (Accu-Chek Aviva Plus test strips)* c) One Touch Ultra (One touch Ultra test strips)*

d) One Touch Verio IQ (One Touch Verio test strips)*


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Diabetic Test Strips (continued)

Aug. 1, 2015 OR 2. Member is currently established on a MiniMed insulin pump or another

insulin pump that communicates wirelessly with a meter that requires Contour test strips.

* Quantity Limits may apply

Extracorporeal Shock Wave Therapy (ESWT)

Jul. 1, 2015 Updated supporting information to reflect the most current clinical evidence, FDA information and references; no change to coverage rationale or list of applicable codes

Extracorporeal shock wave therapy (ESWT), whether low energy, high energy or radial wave, is unproven and not medically necessary for the treatment of: Achilles tendonitis Calcaneal spur Calcific tendonitis of the shoulder (rotator cuff)

Chronic plantar fasciitis (including plantar fibromatosis and plantar nerve lesion)

Delayed or nonunion of fractures Hammer toe Lateral epicondylitis (tennis and golfers elbow)

Tenosynovitis of the foot or ankle

Tibialis tendinitis Wounds including ulcers The available evidence regarding the efficacy of ESWT is conflicting. There is insufficient evidence regarding the durability of the treatment effects of ESWT. Patient selection criteria have not been adequately defined and optimal treatment parameters have not been established. Finally, in some

studies, ESWT is no more effective than sham treatment in relieving pain. Note: This policy does not address extracorporeal shock wave lithotripsy (ESWL).

Gastrointestinal Motility Disorders,

Diagnosis and Treatment

Jul. 1, 2015

Routine review; no change to coverage rationale or lists of

applicable codes

Gastric Electrical Stimulation Therapy Gastric electrical stimulation therapy is proven and medically necessary for

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


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Gastrointestinal Motility Disorders, Diagnosis and Treatment (continued)

Jul. 1, 2015

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

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

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

intractable constipation and for patients with constipation who have one or

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

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

Defecography is unproven and not medically necessary for the routine evaluation of constipation for conditions other than those listed above. Direct visualization is the preferred method of evaluating intractable constipation in the absence of the stated indications above.

MRI defecography is unproven and not medically necessary for the evaluation of constipation and anorectal or pelvic floor disorders.

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

Electrogastrography and Electroenterography


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Gastrointestinal Motility Disorders, Diagnosis and Treatment (continued)

Jul. 1, 2015 Cutaneous, mucous, or serosal electrogastrography or electroenterography is unproven and not medically necessary for diagnosing intestinal or gastric disorders including gastroparesis.

There is insufficient evidence to conclude that electrogastrography or electroenterography can accurately diagnose gastroparesis and other gastric

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

Gynecomastia

Jul. 1, 2015

Routine review; no change to coverage rationale or list of applicable codes

Criteria for a Coverage Determination that surgery is reconstructive and medically necessary: I. Mastectomy or suction lipectomy for treatment of benign gynecomastia

for a male patient under age 18 is considered reconstructive and medically necessary when all the following criteria are met:

A. Gynecomastia or breast enlargement with moderate to severe chest pain that is causing a functional/physical impairment as defined in the Definitions section. The inability to participate in athletic events,

sports or social activities is not considered to be a functional/physical or physiological impairment.

B. No prior history of prescribed medications and appropriate screening(s) of non-prescription and/or recreational drugs or

substances that have a known side effect of gynecomastia. (examples include but are not limited to the following, testosterone, marijuana, asthma drugs, phenothiazines, anabolic steroids, cimetidine and calcium channel blockers).

C. The breast enlargement must be present for at least 2 years. If so, lab tests which might include, but are not limited to the following must be

performed: 1. thyroid function studies;

2. testosterone; 3. Beta subunit HCG

II. Mastectomy or suction lipectomy for treatment of benign gynecomastia

for a male patient age 18 and up is considered reconstructive and medically necessary when all the following criteria are met: A. Discontinuation of medications, nutritional supplements, and non-

prescription medications or substances (examples include but are not limited to the following, testosterone, marijuana, asthma drugs, phenothiazines, anabolic steroids, cimetidine and calcium channel


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Gynecomastia (continued)

Jul. 1, 2015

blockers) that have a known side effect of gynecomastia or breast enlargement and the breast size did not regress after discontinuation of use as appropriate.

B. Gynecomastia or breast enlargement with moderate to severe chest pain that is causing a functional/physical impairment as in the

Definitions section. The inability to participate in athletic events,

sports or social activities is not considered to be a functional/physical or physiological impairment.

C. Review of test results that have been performed to rule out certain diseases or other causes of gynecomastia (examples include but are not limited to blood tests, e.g. hormone levels estrogen, testosterone, liver and kidney function studies/enzymes).

D. Glandular breast tissue is the primary cause of gynecomastia as opposed to fatty deposits and is documented on physical exam and/or mammography.

Additional Information:

In most cases breast enlargement and/or benign gynecomastia

spontaneously resolves by age 18 making treatment unnecessary. Gynecomastia during puberty is not uncommon and in 90% of cases regresses within 3 years of onset. If a tumor or neoplasm is suspected, a breast ultrasound and/or mammogram may be performed. As indicated, a breast biopsy may

also be performed.

Coverage Limitations and Exclusions 1. Treatment of benign gynecomastia when specifically excluded in the

member specific benefit document. 2. Treatment of benign gynecomastia when not specifically excluded in the

member specific benefit document and the above criteria is not met.

3. Most medical and surgical treatments for benign gynecomastia are

considered cosmetic. Medical treatments and surgery to alter a perceived abnormal appearance, or for psychological reasons, are

considered cosmetic and are not covered. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of benign gynecomastia does not classify surgery (or other procedures done to relieve such consequences or behavior) as a reconstructive procedure.


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Macular Degeneration Treatment Procedures

Jul. 1, 2015 Updated supporting information to reflect the most current description of services, clinical evidence, FDA information and references; no change to coverage

rationale or list of applicable codes

Implantable Miniature Telescope (IMT) The implantable miniature telescope is proven and medically necessary when used according to U.S. Food and Drug Administration (FDA) labeled indications for the treatment of patients with end-stage, age-related macular degeneration.

See the FDA section of this policy for a complete list of FDA indications and contraindications for IMT. Conjunctival Incision with Placement of a Pharmacologic Agent Conjunctival incision with posterior extrascleral placement of a pharmacologic agent is unproven and not medically necessary to treat ocular disorders

including age-related macular degeneration. Conjunctival incision with posterior extrascleral placement of a pharmacologic agent has not been demonstrated to be as effective as standard therapy for ocular disorders including macular degeneration. Further studies with larger sample sizes are needed to demonstrate the efficacy of this treatment.

Epiretinal Radiation Therapy

Epiretinal radiation therapy is unproven and not medically necessary for the treatment of ocular disorders including age-related macular degeneration. The evidence does not support the use of epiretinal radiation therapy. Controlled trials with larger patient populations are needed to demonstrate the effectiveness of this procedure.

Laser Photocoagulation Laser photocoagulation is unproven and not medically necessary for the treatment of macular drusen. Results of available studies lead to the conclusion that current prophylactic

laser treatment does not benefit patients who have macular drusen.


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Magneto-encephalography and Magnetic Source Imaging for Specific

Neurological

Applications

Jul. 1, 2015 Routine review; no change to coverage rationale or lists of applicable codes

Magnetoencephalography and magnetic source imaging (MEG/MSI) are considered to be proven and medically necessary for the following: Presurgical evaluation in patients with intractable focal epilepsy Presurgical evaluation of brain tumors and vascular malformations Presurgical planning for refractory epilepsy when other methods do not

localize a seizure focus.

Magnetoencephalography and magnetic source imaging (MEG/MSI) are considered to be unproven and not medically necessary for the evaluation of brain function in patients with trauma, stroke, learning disorders, or other neurologic disorders and psychiatric conditions such as schizophrenia. There is insufficient evidence to conclude that the use of MEG/MSI improves health

outcomes such as improved diagnostic accuracy and treatment planning for patients with trauma, stroke, learning disorders, or other neurologic disorders and psychiatric conditions. Further clinical trials demonstrating the clinical usefulness of this procedure are necessary before it can be considered proven to have a benefit on health outcomes for these conditions.

Preterm Labor: Identification and Treatment

Jul. 1, 2015

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

Tocolytic Therapy The use of tocolytic therapy beyond 7 days is unproven and not medically

necessary for preventing spontaneous preterm birth by prolonging pregnancy. See note below regarding terbutaline. Available studies fail to demonstrate any benefit of maintenance tocolysis in terms of gestational age at birth, pregnancy prolongation or birth weight.

Subcutaneous terbutaline pump maintenance therapy is unproven and not

medically necessary for delaying or preventing spontaneous preterm birth by prolonging pregnancy. Terbutaline pump maintenance therapy has not been shown to decrease the risk of preterm birth by prolonging pregnancy.

Note: On February 17, 2011, the U.S. Food and Drug Administration (FDA) notified healthcare professionals that treatment of preterm labor with

terbutaline administered by injection or by continuous infusion pump should not be used beyond 48 to 72 hours in a hospital setting. In particular, injectable terbutaline should not be used in the outpatient or home setting. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. Death and serious maternal heart problems have

been reported after prolonged administration of oral or injectable terbutaline


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Preterm Labor: Identification and Treatment (continued)

Jul. 1, 2015 to pregnant women. Additional information available at: http://www.fda.gov/ Drugs/DrugSafety/ ucm243539.htm. Accessed March 20, 2015. Home Uterine Activity Monitoring Home uterine activity monitoring (HUAM) is unproven and not medically

necessary for preventing spontaneous preterm birth.

There is insufficient clinical evidence that home uterine activity monitoring, as an independent variable, reduces the frequency of preterm births. Available studies fail to demonstrate that the use of HUAM reduces the rate of preterm delivery and neonatal complications or improves pregnancy outcomes.

Preventive Care

Services

Jul. 1, 2015

Notice of Revision: The following

summary of changes has been modified. Revisions to the policy update announcement previously appearing in the Policy Update

Bulletin are outlined in red below. Please take note of the additional updates to be implemented on July

1, 2015.

Revised coverage rationale/ indications for coverage: o Updated language pertaining

to Cost Sharing for Non-Grandfathered Health

Plans; added language to indicate, depending on the

plan, eligible expenses for services from non-network providers may not equal the provider’s billed charges (refer to plan’s schedule of

benefits) Updated Appendix A – USPSTF

Grade Definitions: o Added Grade Definitions for

Refer to the policy for complete details on the coverage guidelines for

Preventive Care Services.


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Preventive Care Services (continued)

Jul. 1, 2015

USPSTF Recommendations dated after July 2012

o Removed Grade Definitions for USPSTF Recommendations dated prior to May 2007

o Updated Grade Definitions for

USPSTF Recommendations dated after May 2007; revised Grade C Definition to indicate: Clinicians may provide this

service to selected patients depending on individual

circumstances; however, for most individuals without signs or symptoms there is likely to be only a small benefit from this service (this statement is

undergoing USPSTF

revision) Revised list of applicable

procedure codes for Preventive Care Services: o Updated service description

table header to clarify “a date

in this column is when the rating was released, not when the benefit is effective”

Chlamydia Infection Screening

(Females) o Updated service description:

Updated service

title/header to indicate guidelines apply to females

Replaced USPSTF Ratings A and B (June 2007) with USPSTF Rating B (September 2014)


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Jul. 1, 2015

indicating: - The USPSTF

recommends screening for chlamydia in sexually

active women age 24

years and younger and in older women who are at increased risk for infection

Added notation to clarify the USPSTF

recommendation applies to all sexually active adolescents and adult women, including pregnant women

o Reformatted/clarified lists of

applicable diagnosis codes

and claims edit criteria Gonorrhea Screening (Females) o Updated service description:

Updated service title/header to indicate

guidelines apply to females

Replaced USPSTF Rating B (May 2005) with

USPSTF Rating B (September 2014) indicating:

- The USPSTF recommends screening for gonorrhea in sexually

active women age 24 years and younger and in older women


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Jul. 1, 2015

who are at increased risk for infection

o Reformatted/clarified lists of applicable diagnosis codes and claims edit criteria

Hepatitis B Virus Infection

Screening o Reformatted/clarified lists of

applicable diagnosis codes and claims edit criteria

HIV – Human Immunodeficiency Virus –

Screening for Adolescents and Adults o Reformatted/clarified lists of


Syphilis Screening

o Reformatted/clarified lists of


Genetic Counseling and Evaluation for BRCA Testing; and BRCA Lab Screening o Revised language/criteria to

indicate BRCA lab screening is covered for persons with a personal history of breast cancer and/or ovarian cancer

Updated lists of applicable diagnosis codes for BRCA lab screening:

- Added ICD-9 codes V10.3 and V10.43 (personal history)

- Added ICD-10 codes: Z15.01 and

Z15.02 (family history)


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UPDATED



Jul. 1, 2015

Z85.3 and Z85.43 (personal history)

Updated claims edit criteria for BRCA lab screening to indicate:

- BRCA lab screening is

payable for women age 18+ when billed with one of the listed BRCA lab screening diagnosis codes

- Blood draw is payable

when billed with both of the following: One of the BRCA

lab screening procedure codes listed; and

One of the BRCA

lab screening diagnosis codes listed

Removed Cancer Diagnosis Code List for BRCA Lab Screening

Screening Mammography o Updated service description;

added reference link to the medical policy titled Breast

Imaging for Screening and Diagnosing Cancer

o Updated claims edit criteria;

added language to clarify: This benefit only applies

to screening mammography

This benefit does not apply to other screening methods, including but


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UPDATED



Jul. 1, 2015

not limited to, digital breast tomosynthesis (3-D mammography)

Cholesterol Screening (Lipid Disorders Screening)

o Reformatted list of applicable

ICD-9 diagnosis codes for Body Mass Index 40 And Over, Adult

Immunizations o Removed and relocated lists

of applicable codes and claims

edit criteria to new/separate table titled Preventive Immunizations: Added language to

indicate:

- In the case of a public

health emergency (as defined by the Centers for Disease Control or state or local public health

departments), UnitedHealthcare may choose to apply preventive benefits to a new vaccine if the vaccine has FDA

approval, even if an ACIP recommendation has not been announced

- Brand names/trade

names are included, when available, as examples for convenience only;


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UPDATED



Jul. 1, 2015

coverage pursuant to this Coverage Determination Guideline is based solely on the

procedure codes

- Age Group information is provided for

informational use only; for purposes of this document, “adult” means age 18 years and up and “pediatric” means age 0-18 years

- Benefit Limits are

from FDA labeling and ACIP recommendations;

codes that indicate “for applicable age see code description” are limited to the age(s) listed in the code description

Reformatted coverage

guidelines by service type category

- Added CPT/HCPCS code descriptions and

applicable brand/trade names (when available)

- Clarified

content/language pertaining to age and benefit limits


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UPDATED



Jul. 1, 2015

Updated coverage guidelines for CPT code 90723 [Diptheria, tetanus and acellular pertussis, hepatits B, and polio

inactive (DTaP-HepB-

IPV); added benefit limit guideline of 0-6 years (ends on 7th birthday)

Behavioral Counseling in Primary Care to Promote a Healthful Diet and Physical

Activity for Cardiovascular Disease Prevention in Adults with Cardiovascular Risk Factors o Updated service description:

Renamed/retitled service

title/header; previously

titled Behavioral Counseling in Primary Care to Promote a Healthy Diet

Replaced USPSTF Rating B (January 2003) with

USPSTF Rating B (September 2014) indicating:

- The USPSTF

recommends offering or referring adults who are overweight or obese and have additional cardiovascular disease (CVD) risk

factors to intensive behavioral counseling interventions to


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UPDATED



Jul. 1, 2015

promote a healthful diet and physical activity for CVD prevention

o Updated lists of applicable

diagnosis codes to align with

USPSTF recommendations: Added:

Overweight

- ICD-9: 278.02,

V85.21, V85.22, V85.23, V85.24, and V85.25

- ICD-10: E66.3,

Z68.25, Z68.26, Z68.27, Z68.28, and Z68.29

Body Mass Index 30.0 – 39.9

- ICD-9: V85.30,

V85.31, V85.32, V85.33, V85.34, V85.35, V85.36, V85.37, V85.38, and

V85.39

- ICD-10: Z68.30, Z68.31, Z68.32, Z68.33, Z68.34,

Z68.35, Z68.36,

Z68.37, Z68.38, and Z68.39

Body Mass Index 40.0 and Over

- ICD-9: V85.41,

V85.42, V85.43, V85.44, and V85.45

- ICD-10: Z68.41,

Z68.42, Z68.43,


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UPDATED



Jul. 1, 2015 Z68.44, and Z68.45 Impaired Fasting Glucose

- ICD-9: 790.21

- ICD-10: R73.01

Metabolic Syndrome

- ICD-9: 277.7

- ICD-10: E88.81

Changed sub-header/title for “Hyperlipidemia” to “Hyperlipidemia/Dyslipidemia”

Behavioral Counseling to Prevent Sexually Transmitted Infections

o Updated service description; replaced USPSTF Rating B

(October 2008) with USPSTF Rating B (August 2014) indicating: The USPSTF recommends

intensive behavioral

counseling for all sexually active adolescents and for adults who are at increased risk for sexually transmitted infections (STIs)

Soliris

(Eculizumab)

Aug. 1, 2015

Updated coverage rationale;

added language to indicate if service is “proven” or “unproven” to applicable medically necessary/not medically necessary statement

Updated benefit considerations; added language for Essential

Health Benefits for Individual and Small Group plans to indicate:

The guidelines below provide indications for the drug Soliris

(eculizumab). Precertification is not required for the drug Soliris (eculizumab); however the site of service for the administration of Soliris may require precertification. Soliris (eculizumab) is proven and medically necessary for the treatment of:

1. Atypical hemolytic uremic syndrome (aHUS)1 2. Paroxysmal nocturnal hemoglobinuria (PNH)1


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UPDATED


Soliris (Eculizumab) (continued)

Aug. 1, 2015

o For plan years beginning on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual

and small group plans (inside

and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”)

o Large group plans (both self-funded and fully insured), and

small group ASO plans, are not subject to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such

as maternity benefits), the ACA

requires all dollar limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans

o The determination of which benefits constitute EHBs is

made on a state by state basis; as such, when using this guideline, it is important to refer to the member specific

benefit document to determine benefit coverage

Updated supporting information to

reflect the most current clinical evidence, FDA information and references

Revised title of reference line to policy Specialty Medication Administration - Site of Care Review Guidelines; previously

Eculizumab is unproven and not medically necessary for treatment of Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS). Site of Care Administration

Provider’s Office or Freestanding Ambulatory Infusion Suite (not associated with a hospital): Administration of Soliris in a provider’s office or freestanding ambulatory

infusion suite not associated with a hospital does not require precertification. Home Administration: Administration of Soliris in the home requires pre-certification for the home care services (not for the Soliris itself). Refer to the policy titled Home Health Care.

Hospital Outpatient Facility: Administration of Soliris in a hospital outpatient facility (including any

ambulatory infusion suite associated with the hospital) requires precertification with review by a Medical Director or their designee. Refer to the policy titled Specialty Medication Administration - Site of Care Review Guidelines.

https://www.oxhp.com/secure/policy/site_care_review_med_nec_hosp_outpatient_fac_spec_med_infusion.pdf




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UPDATED


Soliris (Eculizumab) (continued)

Aug. 1, 2015 titled Site of Care Review Guidelines for Medical Necessity of Hospital Outpatient Facility Specialty Medication Infusion

Transpupillary

Thermotherapy

Jul. 1, 2015

Updated supporting information to

reflect the most current clinical evidence and references; no change to coverage rationale or list of applicable codes

Transpupillary thermotherapy is proven and medically necessary for the

treatment of retinoblastoma and choroidal melanomas. Transpupillary thermotherapy is unproven and not medically necessary for the treatment choroidal neovascularization or macular degeneration. Results of studies evaluating the use of transpupillary thermotherapy for the prevention or control of choroidal neovascularization lesions in patients with

age-related macular degeneration (AMD) do not provide sufficient evidence to conclude that transpupillary thermotherapy improves loss of vision due to AMD.

REVISED


Drug Coverage

Criteria - New and Therapeutic Equivalent Medications

Aug. 1, 2015 Revised list of medications

requiring precertification through the pharmacy benefit manager (PBM): o Added Atendia 4-3%,

bimatoprost 0.03% (generic Lumigan), Dermacinrx Analgesic kit, DermacinRx

Inflammatral Pak, Dermacinrx Silapak kit, Irenka, Ixinity, Renovo Lido 5, Stiolto

Respimat, Urevaz 44% cream, and Zomacton

o Removed Tev-Tropin

o Updated formulary alternatives for Androgel

Refer to the policy for complete details on Drug Coverage Criteria - New and

Therapeutic Equivalent Medications.


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REVISED

Policy Title Effective Date Drug/Medication Status Summary of Changes

Drug Coverage Guidelines

Aug. 1, 2015

Abilify (Aripiprazole): IM Injection

Revised Changed applicable benefit type classification from “pharmacy” to “medical”

Abilify (Aripiprazole): Tablet, Oral Suspension

Revised

Added coverage guidelines for tablet, oral suspension dosage to indicate authorization will be approved (for 60 months) based on one of the

following criteria (refer to Abilify for complete details on applicable coverage criteria):

o Both of the following: History of greater than or equal to 4 week trial of the therapeutically

equivalent generic (Document date and duration of trial. For Wellbutrin XL, trial must be in 2014 or later); and

Submission of medical records documenting the inadequate

response to the therapeutically equivalent generic OR o Both of the following:

Documented history of intolerance to the therapeutically equivalent generic which is unable to be resolved with attempts to minimize the adverse effects where appropriate (e.g. take with food to minimize

nausea, take prior to bedtime to manage fatigue, take in the morning to manage insomnia, eat high-fiber diet with plenty of water to minimize constipation, etc.); and

Submission of medical records documenting the adverse effect of the therapeutically equivalent generic

Adcirca (Tadalafill) Revised Revised coverage guidelines for treatment of pulmonary arterial

hypertension (refer to Adcirca (tadalafill) for complete details on applicable coverage criteria); o Revised initial authorization criteria:

Removed criterion requiring diagnosis of pulmonary arterial hypertension

Updated criterion pertaining to medical notes to require “submission

of medical records documenting diagnosis of pulmonary arterial

hypertension that is confirmed by right heart catheterization” o Revised reauthorization criteria to indicate approval will be based on

documentation indicating the patient is receiving clinical benefit to Adcirca, Adempas, Opsumit, Letairis, sildenafil citrate tablets (generic Revatio), Tracleer, Tyvaso, or Ventavis therapy

Adempas (Riociguat)

Revised

Revised coverage guidelines (refer to Adempas for complete details on applicable coverage criteria); o Revised initial authorization criteria for treatment of treatment of

pulmonary arterial hypertension:


Oxford


REVISED


Drug Coverage Guidelines (continued)

Aug. 1, 2015

Adempas (Riociguat) (continued)

Revised Removed criterion requiring diagnosis of pulmonary arterial hypertension

Updated criterion pertaining to medical notes to require “submission of medical records documenting diagnosis of pulmonary arterial hypertension that is confirmed by right heart catheterization”

o Revised reauthorization criteria treatment of pulmonary arterial

hypertension to indicate approval will be based on documentation indicating the patient is receiving clinical benefit to Adcirca, Adempas, Opsumit, Letairis, sildenafil citrate tablets (generic Revatio), Tracleer, Tyvaso, or Ventavis therapy

o Revised reauthorization criteria for treatment of chronic thromboembolic pulmonary hypertension (CTEPH) to indicate approval

will be based on documentation indicating the patient is receiving clinical benefit to Adempas therapy

Ampyra (Dalfampridine) Updated Removed “educational statement”; no change to coverage guidelines

Androgel (Testosterone) Revised Revised coverage guidelines (refer to Drug Coverage Criteria - New and

Therapeutic Equivalent Medications for complete details on applicable

coverage criteria): o Added new/additional coverage criterion requiring history of intolerance

or therapeutic failure to treatment with Androderm

Atendia 4-3% (Menthol/Lidocaine)

New Added coverage guidelines (precertification requirements apply); refer to Drug Coverage Criteria - New and Therapeutic Equivalent Medications for

complete details on applicable coverage criteria

Aubagio (Teriflunomide) Revised Revised coverage guidelines (refer to Step Therapy: Aubagio (teriflunomide) for complete details on applicable coverage criteria); o Revised criterion pertaining to use of a manufacture supplied sample to

specify sample is received at no cost “from a prescriber office or a 30

day free trial from a pharmacy” as a means to establish as a current user

Bimatoprost 0.03% (Generic Lumigan)

New Added coverage guidelines (precertification requirements apply); refer to Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details on applicable coverage criteria

Dermacinrx Analgesic Kit (Diclofenac Tablet and Lidocaine, Menthol, Methyl Salicylate Patch)


Dermacinrx Inflammatral

Pak (Chlorhexidine

New Added coverage guidelines (precertification requirements apply); refer to

Drug Coverage Criteria - New and Therapeutic Equivalent Medications for


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REVISED



Aug. 1, 2015

Gluconate and Dimethicone Combination Kit)

complete details on applicable coverage criteria

Dermacinrx Silapak Kit

(Triamcinolone Cream, Dimethicone Cream and

Silicone Tape)

New Added coverage guidelines (precertification requirements apply); refer to

Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details on applicable coverage criteria

Evista (Raloxifene) (Brand Only)

Updated Routine review; no change to coverage guidelines

Exjade (Deferasirox) Updated Routine review; no change in coverage guidelines

Extavia (Interferon B-1b)

Revised Revised coverage guidelines (refer to Step Therapy: Extavia (interferon B-1b) for complete details on applicable coverage criteria); o Revised criterion pertaining to use of a manufacture supplied sample to



Ferriprox (Deferiprone) Updated Reformatted coverage criteria; no change in coverage guidelines

Flector (Diclofenac) Revised Changed applicable dosage form from “suspension” to “patch”

Genotropin (Somatropin)

Revised

Revised coverage guidelines (refer to Genotropin (somatropin) for complete details on applicable coverage criteria); Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:

Updated criterion pertaining to submission of medical records to indicate notes must document pediatric growth hormone is dosed

according to FDA-approved labeling for growth hormone deficiency (as listed)

Adult Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:

Updated criterion pertaining to applicable diagnoses to indicate one

of the following is required: - Diagnosis of panhypopituitarism; or

- Other diagnosis and not used in combination with the following: Aromatase inhibitors [e.g., Arimidex (anastrazole), Femara

(letrazole)] Androgens [e.g., Delatestryl (testoseterone enanthate), Depo-

Testosterone (testosterone cypionate)]” Updated criterion pertaining to submission of medical records to

indicate notes must document adult growth hormone is dosed


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REVISED



Aug. 1, 2015

Genotropin (Somatropin) (continued)

Revised according to FDA-approved labeling for growth hormone deficiency (as listed)

Gilenya (Fingolimod) Revised Revised coverage guidelines (refer to Step Therapy: Gilenya (fingolimod) for complete details on applicable coverage criteria);

o Revised criterion pertaining to use of a manufacture supplied sample to specify sample is received at no cost “from a prescriber office or a 30


o Added language to indicate members currently on Gilenya as documented in claims history will be allowed to continue on their current therapy; members new to therapy will be required to meet the

criteria as noted

Grastek (Timothy Grass Pollen Allergen Extract)

Updated Revised coverage guidelines (refer to Grastek (Timothy Grass Pollen Allergen Extract) for complete details on applicable coverage criteria); o Updated criterion outlining applicable diagnoses; modified list of

examples of grass species to include reference to “mixed pollens”

Hemophilia Drugs Revised Revised coverage guidelines:

o Updated list of applicable hemophilia drugs; added “Ixinity” (precertification requirements apply)

o Revised coverage guidelines for Novoeight; added reference link to related policy titled Drug Coverage Criteria - New and Therapeutic Equivalent Medications

Hetlioz (Tasimelteon) Updated Routine review; no change to coverage guidelines

Humatrope (Somatropin)

Revised

Revised coverage guidelines (refer to Humatrope (somatropin) for complete details on applicable coverage criteria); Pediatric Growth Hormone Deficiency

o Revised criteria for initial therapy and reauthorization: Updated criterion pertaining to submission of medical records to

indicate notes must document pediatric growth hormone is dosed

according to FDA-approved labeling for growth hormone deficiency (as listed)


Updated criterion pertaining to applicable diagnoses to indicate one of the following is required: - Diagnosis of panhypopituitarism; or - Other diagnosis and not used in combination with the following:

Aromatase inhibitors [e.g., Arimidex (anastrazole), Femara


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REVISED



Aug. 1, 2015

Humatrope (Somatropin) (continued)

Revised (letrazole)] Androgens [e.g., Delatestryl (testoseterone enanthate), Depo-

Testosterone (testosterone cypionate)]” o Updated criterion pertaining to submission of medical records to

indicate notes must document adult growth hormone is dosed according

to FDA-approved labeling for growth hormone deficiency (as listed)

Increlex (Mecasermin)

Revised

Revised coverage guidelines (refer to Increlex (mecasermin) for complete details on applicable coverage criteria); Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:

Updated criterion pertaining to submission of medical records to

indicate notes must document pediatric growth hormone is dosed according to FDA-approved labeling for growth hormone deficiency (as listed)



of the following is required: - Diagnosis of panhypopituitarism; or - Other diagnosis and not used in combination with the following:

Aromatase inhibitors [e.g., Arimidex (anastrazole), Femara (letrazole)]

Androgens [e.g., Delatestryl (testoseterone enanthate), Depo-Testosterone (testosterone cypionate)]”

o Updated criterion pertaining to submission of medical records to indicate notes must document adult growth hormone is dosed according to FDA-approved labeling for growth hormone deficiency (as listed)

Infergen, (Interferon Alfacon-1)

Removed Removed coverage guidelines

Intron-A (Interferon Alfa-2b)

Revised

Revised coverage guidelines (refer to Intron-A (interferon alpha-2b) for complete details on applicable coverage criteria); o Updated service description/sub-header for Treatment of Chronic

Hepatitis C (Intron-A); previously titled Treatment of Chronic Hepatitis C (Excluding Protease Inhibitor Triple Drug Therapy)

o Revised criteria for the treatment of diagnoses other than hepatitis to

indicate approval will be based one of the following diagnoses: Hairy cell leukemia; or Condylomata acuminata (genital or perianal) ; or AIDS-related Kaposi’s sarcoma; or

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


Oxford


REVISED



Aug. 1, 2015

Intron-A (Interferon Alfa-2b) (continued)

Revised Leptomeningeal metastases; or Meningiomas; or Kidney cancer; or Multiple myeloma; or Systemic light chain amyloidosis; or

Follicular lymphoma; or

Adult T-cell leukemia / lymphoma; or Mycosis fungoides / Sézary syndrome; or Desmoid tumors / aggressive fibromatosis; or Giant cell tumor of the bone; or Chronic myelogenous leukemia (CML); or Malignant Melanoma; or

Primary cutaneous CD30+ T-Cell lymphoproliferative disorders

Irenka (Duloxetine) New Added coverage guidelines (precertification requirements apply); refer to Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details on applicable coverage criteria

Jakafi (Ruxolitinib) Revised Revised coverage guidelines (refer to Jakafi) for complete details on

applicable coverage criteria); o Added coverage criteria for treatment of polycythemia vera to indicate:

Initial authorization will be approved (for 6 months) based on both of the following criteria: - Diagnosis of polycythemia vera - History of failure, inadequate response, contraindication, or

intolerance to hydroxyurea Reauthorization will be approved based on one of the following

criterion: - Documentation that member has evidence of symptom

improvement or reduction in spleen volume while on Jakafi (authorization will be issued for 6 months); or

- Documentation does not provide evidence of symptom

improvement or reduction in spleen volume while on Jakafi, allow for dose titration with discontinuation of therapy (authorization will be issued for 2 months)

Letairis (Ambrisentan)

Revised

Revised coverage guidelines for treatment of pulmonary arterial hypertension (refer to Letairis for complete details on applicable coverage

criteria); o Revised initial authorization criteria:


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


Oxford


REVISED



Aug. 1, 2015

Letairis (Ambrisentan) (continued)

Revised Updated criterion pertaining to medical notes to require “submission of medical records documenting diagnosis of pulmonary arterial hypertension that is confirmed by right heart catheterization”

o Revised reauthorization criteria to indicate approval will be based on documentation indicating the patient is receiving clinical benefit to

Adcirca, Adempas, Opsumit, Letairis, sildenafil citrate tablets (generic

Revatio), Tracleer, Tyvaso, or Ventavis therapy

Lotronex (Alosetron) Updated Routine review; no change to coverage guidelines

Mekinist (Trametinib) Revised Revised coverage guidelines (refer to Mekinist (Trametinib) for complete details on applicable coverage criteria);

o Revised initial authorization criteria to indicate approval will be based on both of the following criteria: One of the following diagnoses:

- Unresectable melanoma - Metastatic melanoma

and

Cancer is BRAFV600 mutant type (MT)

o Changed approval timeframe for initial authorization and reauthorization from “5 months” to “12 months”

Mifeprex (Mifepristone) Revised Revised coverage guidelines (refer to Mifeprex® (Mifepristone, RU-486) for complete details on applicable coverage criteria): o Replaced language indicating “mifepristone is medically necessary for

termination of pregnancy through 49 days gestation” with “mifepristone is proven and medically necessary for termination of pregnancy through 63 days gestation”

o Added language to indicate, for purposes of this treatment, pregnancy is dated from the first day of the last menstrual period in a presumed 28 day cycle with ovulation occurring at mid-cycle

Revised reference link to related policies; replaced Abortions (Therapeutic

and Elective) with Mifeprex® (Mifepristone, RU-486)

Norditropin AQ (Somatropin)

Revised

Revised coverage guidelines (refer to Norditropin (somatropin) for complete details on applicable coverage criteria); Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:

Updated criterion pertaining to submission of medical records to indicate notes must document pediatric growth hormone is dosed according to FDA-approved labeling for growth hormone deficiency (as listed)

https://www.oxhp.com/secure/policy/mifeprex.pdf


Oxford


REVISED



Aug. 1, 2015

Norditropin AQ (Somatropin) (continued)

Revised


Updated criterion pertaining to applicable diagnoses to indicate one of the following is required: - Diagnosis of panhypopituitarism; or

- Other diagnosis and not used in combination with the following:



o Updated criterion pertaining to submission of medical records to indicate notes must document adult growth hormone is dosed according


Norditropin (Somatropin) Revised Revised coverage guidelines (refer to Norditropin (somatropin) for complete details on applicable coverage criteria); Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:







o Updated criterion pertaining to submission of medical records to indicate notes must document adult growth hormone is dosed according to FDA-approved labeling for growth hormone deficiency (as listed)

Norditropin Nordiflex (Somatropin)

Revised

Revised coverage guidelines (refer to Norditropin (somatropin) for complete details on applicable coverage criteria);

Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:



Oxford


REVISED



Aug. 1, 2015

Norditropin Nordiflex (Somatropin) (continued)

Revised






Androgens [e.g., Delatestryl (testoseterone enanthate), Depo-


indicate notes must document adult growth hormone is dosed according to FDA-approved labeling for growth hormone deficiency (as listed)

Nuspin (Somatropin) Revised Revised coverage guidelines (refer to NuSpin (somatropin) for complete

details on applicable coverage criteria); Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:



Updated criterion pertaining to applicable diagnoses to indicate one of the following is required: - Diagnosis of panhypopituitarism; or

- Other diagnosis and not used in combination with the following: Aromatase inhibitors [e.g., Arimidex (anastrazole), Femara




Nutropin and Nutropin AQ (Somatropin)

Revised

Revised coverage guidelines (refer to Nutropin and Nutropin AQ (somatropin) for complete details on applicable coverage criteria);


Oxford


REVISED



Aug. 1, 2015

Nutropin and Nutropin AQ (Somatropin) (continued)

Revised Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:

Updated criterion pertaining to submission of medical records to indicate notes must document pediatric growth hormone is dosed according to FDA-approved labeling for growth hormone deficiency

(as listed)


Updated criterion pertaining to applicable diagnoses to indicate one of the following is required: - Diagnosis of panhypopituitarism; or - Other diagnosis and not used in combination with the following:





Omnitrope (Somatropin)

Revised

Revised coverage guidelines (refer to Omnitrope (somatropin) for complete details on applicable coverage criteria); Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:




Updated criterion pertaining to applicable diagnoses to indicate one of the following is required:

- Diagnosis of panhypopituitarism; or - Other diagnosis and not used in combination with the following:





Oxford


REVISED



Aug. 1, 2015

Omnitrope (Somatropin) (continued)

Revised to FDA-approved labeling for growth hormone deficiency (as listed)

Opsumit (Macitentan)

Revised

Revised coverage guidelines for treatment of pulmonary arterial

hypertension (refer to Opsumit for complete details on applicable coverage criteria);

o Revised initial authorization criteria: Removed criterion requiring diagnosis of pulmonary arterial

hypertension Updated criterion pertaining to medical notes to require “submission

of medical records documenting diagnosis of pulmonary arterial

hypertension that is confirmed by right heart catheterization” o Revised reauthorization criteria to indicate approval will be based on


Oralair (Sweet Vernal,

Orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract)

Updated Revised coverage guidelines (refer to Oralair (Sweet Vernal, Orchard,

Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract) for complete details on applicable coverage criteria); o Updated criterion outlining applicable diagnoses; modified list of


Orenitram (Treprostinil)

Revised


hypertension (refer to Orenitram for complete details on applicable coverage criteria); o Revised initial authorization criteria s to indicate authorization will be

approved (for 6 months) based on one of the following criteria: Both of the following:

- As continuation of therapy; and - Patient has not received a manufacturer supplied sample at no

cost from a prescriber office or a 30 day free trial from a pharmacy as a means to establish as a current user of Orenitram

or All of the following:

- One of the following All of the following:

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

pulmonary arterial hypertension that is confirmed by right heart catheterization


Oxford


REVISED



Aug. 1, 2015

Orenitram (Treprostinil) (continued)

Revised or Patient is currently on any therapy for the diagnosis of

pulmonary arterial hypertension and

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

following:

One of the following o A PDE-5 inhibitor (e.g. sildenafil citrate (generic Revatio),

Adcirca or Revatio*); or o Adempas; and o An ERA (e.g. Letairis, Opsumit or Tracleer)

o Revised reauthorization criteria to indicate authorization will be

approved (for 12 months) based on the following criteria: Patient is receiving clinical benefit to Orenitram therapy

Pegasys (Peginterferon Alfa-2a)

Revised

Revised coverage guidelines (refer to Pegasys (peginterferon alfa-2a) for complete details on applicable coverage criteria); o Revised criteria for treatment of Chronic Hepatitis C:

Updated service description/sub-header for Treatment of Chronic Hepatitis C (Pegasys and PegIntron); previously titled Treatment of Chronic Hepatitis C (Protease Inhibitor Triple Drug Therapy)

Revised initial authorization criteria to indicate Pegasys, as part of a combination antiviral treatment regimen, will be approved (for 28 weeks) based on all of the following criteria: - Diagnosis of chronic hepatitis C infection; and

- Patient without decompensated liver disease* (*Defined as Child-Pugh Class B or C); and

- Will be used in combination with one of the following: Olysio (simeprevir) Sovaldi (sofosbuvir)

Ribavirin Removed criteria pertaining to treatment-naïve patients,

retreatment and continuation of therapy Revised reauthorization criteria to indicate Pegasys will be approved

for continuation of therapy (for an additional 20 weeks) based on all of the following criteria: - Patient has an undetectable HCV RNA at week 24; and - Additional treatment weeks of Pegasys are required to complete

treatment regimen; and - The patient has not exceeded 48 weeks of therapy

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


Oxford


REVISED



Aug. 1, 2015

Pegasys (Peginterferon Alfa-2a) (continued)

Revised Removed reauthorization guidelines for a second continuation of therapy (as part of a treatment regimen with Incivek) period in patients with HCV genotype 1 infection

Removed criteria for initial therapy and reauthorization for: - Pegasys as part of a treatment regimen with Olysio™ (simeprevir)

- Pegasys as part of a treatment regimen with Victrelis®

(boceprevir) o Removed criteria for the treatment of Chronic Hepatitis C (Nucleotide

Analog NS5B Polymerase Inhibitor Triple Drug Therapy) o Revised criteria for the treatment of diagnoses other than hepatitis to

indicate approval will be based one of the following diagnoses: Chronic myelogenous leukemia (CML); or

Giant cell tumor of the bone; or For the treatment of myeloproliferative neoplasms (MPNs) such as

essential thrombocytopenia (ET), polycythemia vera (PV), or primary myelofibrosis (PM)

Peg-Intron

(Peginterferon Alfa-2b)

Revised

Revised coverage guidelines (refer to Prior Authorization: PEG-Intron

(peginterferon alfa-2b) for complete details on applicable coverage criteria); o Revised criteria for treatment of Chronic Hepatitis C:

Updated service description/sub-header for Treatment of Chronic Hepatitis C (Pegasys and PegIntron); previously titled Treatment of Chronic Hepatitis C (Protease Inhibitor Triple Drug Therapy)

Revised initial authorization criteria to indicate PegIntron, as part of

a combination antiviral treatment regimen, will be approved (for 28 weeks) based on all of the following criteria: - Diagnosis of chronic hepatitis C infection; and - Patient without decompensated liver disease* (*Defined as Child-

Pugh Class B or C); and

- Will be used in combination with one of the following: Olysio (simeprevir)

Sovaldi (sofosbuvir) Ribavirin

Removed criteria pertaining to treatment-naïve patients, retreatment and continuation of therapy

Revised reauthorization criteria to indicate PegIntron will be approved for continuation of therapy (for an additional 20 weeks)

based on all of the following criteria: - Patient has an undetectable HCV RNA at week 24; and


Oxford


REVISED



Aug. 1, 2015

Peg-Intron (Peginterferon Alfa-2b) (continued)

Revised - Additional treatment weeks of PegIntron are required to complete treatment regimen; and

- The patient has not exceeded 48 weeks of therapy Removed reauthorization guidelines for a second continuation of

therapy (as part of a treatment regimen with Incivek) period in

patients with HCV genotype 1 infection

Removed criteria for initial therapy and reauthorization for: - PegIntron as part of a treatment regimen with Olysio™

(simeprevir) - PegIntron as part of a treatment regimen with Victrelis®

(boceprevir) o Removed criteria for the treatment of Chronic Hepatitis C (Nucleotide

Analog NS5B Polymerase Inhibitor Triple Drug Therapy) o Revised criteria for the treatment of diagnoses other than hepatitis to

indicate approval will be based one of the following diagnoses: Chronic myelogenous leukemia (CML); or Giant cell tumor of the bone

Pomalyst (Pomalidomide)

Revised Revised coverage guidelines (refer to Pomalyst for complete details on applicable coverage criteria); o Revised initial authorization criteria:

Updated criterion outlining prior therapies for which history of intolerance or therapeutic failure must be demonstrated; replaced “Revlimid (lenalidomide)” with “immunomodulatory agent [e.g. Revlimid (lenalidomide)]”

Changed approval timeframe from “8 months” to “12 months” o Revised reauthorization criteria; changed approval timeframe from “8

months” to “12 months”

Ragwitek (Short Ragweed Pollen Allergen

Extract)

Updated Revised coverage guidelines (refer to Ragwitek (Short Ragweed Pollen Allergen Extract) for complete details on applicable coverage criteria);

o Updated criterion outlining applicable diagnoses; modified list of


Rebif (Interferon Beta-1a)

Updated Revised coverage guidelines (refer to Step Therapy: Rebif for complete details on applicable coverage criteria): o Revised criterion pertaining to use of a manufacture supplied sample to




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REVISED



Aug. 1, 2015

Renovo Lido 5 (Lidocaine/Menthol/ Capsaicin)


Repository Corticotropin

Injection (H.P.Acthar Gel): Injection By A

Medical Professional


Revatio (Sildenafil Citrate)

Revised

Revised coverage guidelines for treatment of pulmonary arterial hypertension (refer to Revatio (sildenafil citrate) for complete details on applicable coverage criteria);

o Revised initial authorization criteria: Removed criterion requiring diagnosis of pulmonary arterial


of medical records documenting diagnosis of pulmonary arterial hypertension that is confirmed by right heart catheterization”

Removed language indicating authorization should be entered for

sildenafil citrate only (generic Revatio) if Revatio brand tablets are excluded from coverage

o Revised reauthorization criteria to indicate approval will be based on documentation indicating the patient is receiving clinical benefit to Adcirca, Adempas, Opsumit, Letairis, sildenafil citrate tablets (generic Revatio), Tracleer, Tyvaso, or Ventavis therapy

Revatio (Sildenafil Citrate) 10mg/ml

Revised Revised coverage guidelines for treatment of pulmonary arterial hypertension (refer to Revatio (sildenafil citrate) for complete details on applicable coverage criteria); o Revised initial authorization criteria:



Removed language indicating authorization should be entered for sildenafil citrate only (generic Revatio) if Revatio brand tablets are excluded from coverage

o Revised reauthorization criteria to indicate approval will be based on documentation indicating the patient is receiving clinical benefit to Adcirca, Adempas, Opsumit, Letairis, sildenafil citrate tablets (generic Revatio), Tracleer, Tyvaso, or Ventavis therapy


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REVISED



Aug. 1, 2015

Revlimid (Lenalidomide)

Revised

Revised coverage guidelines (refer to Revlimid for complete details on applicable coverage criteria); o Revised criteria for treatment of Myeloma:

Updated service description/sub-header; previously titled Multiple Myeloma

Revised initial authorization criteria to indicate approval will be

based on one of the following diagnoses: - Multiple myeloma - Progressive solitary plasmacytoma [off-label] - Smoldering myeloma [off-label] - Systemic light chain amyloidosis [off-label]

o Revised initial authorization criteria for treatment of Myelodysplastic

Syndromes (MDS) to indicate approval will be based on one of the following criteria: Diagnosis of anemia due to myelodysplastic syndrome (MDS)

associated with a deletion 5q cytogenic abnormality; or Both of the following:

- Diagnosis of anemia due to myelodysplastic syndrome without

deletion 5q cytogenic abnormality (off-label); and

- One of the following: Serum erythropoetin levels >500 mU/mL; or All of the following:

o Serum erythropoetin levels ≤ 500 mU/mL; and o History of failure, contraindication, or intolerance to

erythropoietins [e.g., Procrit (epoetin alfa)]; and

o History of failure, contraindication, or intolerance to initial treatment with immunosuppressive therapy [e.g., antithymocyte globulin [ATG], Neoral/Sandimmune/ Gengraf (cyclosporine)]

o Revised initial authorization criteria guidelines for treatment of Non-Hodgkin's Lymphomas (NHL) to indicate approval will be based on one of the following criteria:

Both of the following: - Diagnosis of relapsed, refractory, or progressed mantle cell

lymphoma (MCL); and - History of failure, contraindication, or intolerance to at least one

prior MCL therapies (e.g. Bortezomib, bendamustine, cladribine, rituximab)

Both of the following [off-label]:


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REVISED



Aug. 1, 2015

Revlimid (Lenalidomide) (continued)

Revised - One of the following diagnoses: AIDS-related B-cell lymphoma Diffuse large B-cell lymphoma Chronic lymphocytic leukemia (CLL)/ small lymphocytic

lymphoma (SLL)

Follicular lymphoma

Gastric MALT lymphoma Nongastric MALT lymphoma Primary cutaneous B-cell lymphoma Splenic marginal zone lymphoma Castleman’s Disease (CD)

and

- Not used as first line therapy o Removed coverage guidelines for the treatment of

Mantle Cell Lymphoma (MCL) Solitary Plasmacytoma (off label) Light Chain Amyloidosis (off label)

o Revised initial authorization criteria for treatment of Myelofibrosis;

changed authorization approval timeframe from “6 months” to “12

months”

Saizen (Somatropin)

Revised

Revised coverage guidelines (refer to Saizen (somatropin) for complete details on applicable coverage criteria); Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:


Adult Growth Hormone Deficiency

o Revised criteria for initial therapy and reauthorization: Updated criterion pertaining to applicable diagnoses to indicate one






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REVISED



Aug. 1, 2015

Saizen (Somatropin) (continued)

Revised indicate notes must document adult growth hormone is dosed according to FDA-approved labeling for growth hormone deficiency (as listed)

Serostim (Somatropin)

Revised

Revised coverage guidelines (refer to Serostim (somatropin) for complete details on applicable coverage criteria);

Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:


Adult Growth Hormone Deficiency

o Revised criteria for initial therapy and reauthorization: Updated criterion pertaining to applicable diagnoses to indicate one


Aromatase inhibitors [e.g., Arimidex (anastrazole), Femara




Sildenafil Citrate (Generic Revatio)

Revised Revised coverage guidelines for treatment of pulmonary arterial hypertension (refer to Revatio (sildenafil citrate) for complete details on applicable coverage criteria); o Revised initial authorization criteria:


Updated criterion pertaining to medical notes to require “submission


Removed language indicating authorization should be entered for sildenafil citrate only (generic Revatio) if Revatio brand tablets are excluded from coverage

o Revised reauthorization criteria to indicate approval will be based on



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REVISED



Aug. 1, 2015

Sirturo (Bedaquiline) Updated Routine review; no change to coverage guidelines

Soltamox (Tamoxifen Citrate)


Stiolto Respimat (Olodaterol/Tiotropium)


Sylatron (Peginterferon Alfa-2b)

Revised

Revised coverage guidelines (refer to Infergen (interferon alfacon-1) for complete details on applicable coverage criteria); o Revised coverage criteria for the treatment of diagnoses other than

hepatitis to indicate approval will be based one of the following diagnoses (authorization will be issued for 12 months): Malignant melanoma; or Giant cell tumor of the bone

Synarel (Nafarelin

Acetate)

Revised Revised coverage guidelines (refer to Synarel (nafarelin acetate) for

complete details on applicable coverage criteria); o Removed coverage guidelines/criteria for the treatment of infertility (off

label)

Tafinlar (Dabrafenib)

Revised

Revised coverage guidelines (refer to Tafinlar for complete details on applicable coverage criteria); Melanoma

o Revised coverage criteria to indicate: Initial authorization will be approved for 12 months based on both

of the following criteria: - One of the following diagnoses:

Unresectable melanoma Metastatic melanoma

and - Cancer is BRAFV600 mutant type (MT)

o Reauthorization will approved for 12 months if the patient does not

show evidence of progressive disease while on Tafinlar therapy Central Nervous System (CNS) Cancers [off-label] o Added coverage criteria to indicate:

Initial authorization will be approved for 12 months based on both

of the following criteria: - Metastatic brain lesions that are recurrent; and - Tafinlar is active against primary tumor (melanoma)

Reauthorization will approved for 12 months if the patient does not show evidence of progressive disease while on Tafinlar therapy




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REVISED



Aug. 1, 2015

Tafinlar (Dabrafenib) (continued)

Revised Non-Small Cell Lung Cancer (NSCLC) [off-label] o Added coverage criteria to indicate:

Initial authorization will approved for 12 months based on both the following: - Diagnosis of non-small cell lung cancer (NSCLC); and

- Cancer is positive for BRAFV600E mutation

Reauthorization will approved for 12 months if the patient does not show evidence of progressive disease while on Tafinlar therapy

Tamoxifen Updated Routine review; no change to coverage guidelines

Tev-Tropin (Somatropin) Removed Removed coverage guidelines

Thalomid (Thalidomide): Oral

Revised

Revised coverage guidelines to treat specific conditions (refer to Thalomid for complete details on applicable coverage criteria); o Revised criteria for treatment of Myeloma:

Updated service description/sub-header; previously titled Multiple Myeloma

Revised initial authorization criteria to indicate approval will be based on one of the following diagnoses:

- Multiple myeloma - Progressive solitary plasmacytoma [off-label] - Smoldering myeloma [off-label] - Systemic light chain amyloidosis [off-label]

o Revised initial authorization criteria for the treatment of Erythema

Nodosum Leprosum (ENL); added new/additional criterion requiring one of the following: Use for acute treatment; or Use as maintenance therapy for prevention & suppression of

cutaneous manifestations of ENL recurrence o Revised initial authorization criteria for treatment of Pyoderma

Gangrenosum (off label); added new/additional criterion requiring the

following: Use as 3rd line treatment

o Revised criteria for treatment of Cutaneous Manifestations Systemic Lupus Erythematosus (SLE) (off-label): Updated service description/sub-header; previously titled Systemic

Lupus Erythematosus (SLE) (off-label)

Revised initial authorization criteria to indicate approval will based on the following criteria: - Diagnosis of cutaneous manifestations of systemic lupus

erythematosus (SLE)



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REVISED



Aug. 1, 2015

Thalomid (Thalidomide): Oral (continued)

Revised o Removed coverage criteria for treatment of: Systemic Light Chain Amyloidosis (off label) Mantle Cell Lymphoma (off label) AIDS related Cachexia or Wasting (off label) AIDS related Kaposi’s Sarcoma (off label)

Graft versus Host Disease (GVHD) (off label)

Crohn’s Disease (CD) (off label) Glioblastoma Multiforme (off label) Myelodysplastic Syndrome (MDS) (off label) Behçet’s Disease (off-label) Erosive Lichen Planus (off label) Esophageal Aphthous Ulcers in HIV-infected Patients (off-label)

Plasmacytoma (off-label)

Tracleer (Bosentan) Revised Revised coverage guidelines for treatment of pulmonary arterial hypertension (refer to Tracleer (bosentan) for complete details on applicable coverage criteria); o Revised initial authorization criteria:




Adcirca, Adempas, Opsumit, Letairis, sildenafil citrate tablets (generic Revatio), Tracleer, Tyvaso, or Ventavis therapy

Tyvaso (Treprostinil) Revised Revised coverage guidelines for treatment of pulmonary arterial hypertension (refer to Tyvaso (treprostinil) for complete details on applicable coverage criteria);

o Revised initial authorization criteria:



o Revised reauthorization criteria to indicate approval will be based on



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REVISED



Aug. 1, 2015

Urevaz 44% Cream (Urea)


Vecamyl

(Mecamylamine)


Ventavis (Iloprost)

Revised

Revised


hypertension (refer to Ventavis (iloprost) for complete details on applicable coverage criteria); o Revised initial authorization criteria:

Removed criterion requiring diagnosis of pulmonary arterial




Adcirca, Adempas, Opsumit, Letairis, sildenafil citrate tablets (generic

Revatio), Tracleer, Tyvaso, or Ventavis therapy

Zelboraf (Vemurafenib)

Revised

Revised coverage guidelines (refer to Zelboraf for complete details on applicable coverage criteria); o Changed approval timeframe for initial authorization and

reauthorization from “5 months” to “12 months”

o Added coverage guidelines for the following diagnoses: Central Nervous System (CNS) Cancers [off-label] Initial authorization will be approved for 12 months based on the

following diagnosis: - Metastatic brain lesions that are recurrent; and - Zelboraf is active against primary tumor (melanoma)

Reauthorization will be approved for 12 months if the patient does

not show evidence of progressive disease while on Zelboraf therapy Non-Hodgkin lymphoma (NHL) [off-label] Initial authorization will be approved for 12 months based on a

diagnosis of hairy cell leukemia Reauthorization will be approved for 12 months if the patient does

not show evidence of progressive disease while on Zelboraf therapy

Non-Small Cell Lung Cancer (NSCLC) [off-label] Initial authorization will be approved for 12 months based on the

following diagnosis: - Diagnosis of non-small cell lung cancer (NSCLC); and


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REVISED



Aug. 1, 2015

Zelboraf (Vemurafenib) (continued)

Revised - Cancer is positive for BRAFV600E mutation Reauthorization will be approved for 12 months if the patient does

not show evidence of progressive disease while on Zelboraf therapy

Zomacton (Somatropin) New Added coverage guidelines (precertification requirements apply); refer to

Drug Coverage Criteria - New and Therapeutic Equivalent Medications for complete details on applicable coverage criteria

Zorbtive (Somatropin)

Revised

Revised coverage guidelines (refer to Zorbtive (somatropin) for complete details on applicable coverage criteria); Pediatric Growth Hormone Deficiency o Revised criteria for initial therapy and reauthorization:









REVISED


Omnibus Codes Aug. 1, 2015 Revised coverage summary; added language to indicate precertification with Medical Director review is required for all services addressed in the policy unless otherwise noted

Refer to the policy for complete details on the coverage guidelines for Omnibus Codes.


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REVISED


Repository Corticotropin Injection (H.P. Acthar Gel)

Aug. 1, 2015

Revised benefit considerations: o Removed language indicating

the state of New Jersey prohibits requiring failed prior therapy or intolerance to therapy as a requirement for

coverage o Added language for Essential

Health Benefits for Individual and Small Group plans to

indicate: For plan years beginning

on or after January 1, 2014, the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered

individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits (“EHBs”)

Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer

coverage for EHBs;

however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar limits

on those benefits to be removed on all

This policy addresses H.P. Acthar Gel when administered by a medical professional and covered under the medical benefit. For coverage guidelines for self-administration of H.P. Acthar Gel, refer to: Drug Coverage Guidelines.

Repository corticotropin injection (H.P. Acthar Gel) is medically necessary

for the treatment of: 1. Infantile spasm (i.e., West Syndrome)

Repository corticotropin injection is medically necessary for the treatment of infantile spasms for up to 4 weeks when all of the following criteria are met: A. Diagnosis of infantile spasms (i.e., West Syndrome); and B. Patient is less than 2 years old; and C. Repository corticotropin injection dosing for infantile spasm is as

follows:

a. Initial dose: 75 U/m2 intramuscular (IM) twice daily for 2 weeks.

b. After 2 weeks, dose should be tapered according to the following schedule: 30 U/m2 IM in the morning for 3 days; 15 U/m2 IM in the morning for 3 days; 10 U/m2 IM in the morning for 3 days; and 10 U/m2 IM every other morning for 6 days (3 doses).

2. Opsoclonus-myoclonus syndrome (i.e., OMS, Kinsbourne

Syndrome)

Repository corticotropin injection is not medically necessary for treatment of acute exacerbations of multiple sclerosis. Published clinical evidence does not demonstrate superiority of Acthar to other available

corticosteroids.

The H.P. Acthar package insert has listed other conditions in which it may be used. Since H.P. Acthar is more costly than an alternative drug that is at least as likely to produce equivalent therapeutic results, UHCP has determined that use of H.P. Acthar Gel is unproven and not medically

necessary for treatment of the following disorders and diseases: Repository corticotropin injection is not medically necessary for treatment of the following: A. Rheumatic Disorders: psoriatic arthritis, rheumatoid arthritis, including


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REVISED


Repository Corticotropin Injection (H.P. Acthar Gel) (continued)

Aug. 1, 2015

Grandfathered and Non-Grandfathered plans

The determination of which benefits constitute EHBs is made on a state

by state basis; as such,

when using this guideline, it is important to refer to the member specific benefit document to determine benefit coverage

Updated list of applicable ICD-9 diagnosis codes; added 379.59

Updated list of applicable ICD-10 diagnosis codes (preview draft effective 10/01/15); added H55.89

Updated supporting information

to reflect the most current clinical evidence and references

juvenile rheumatoid arthritis, ankylosing spondylitis B. Collagen Diseases: systemic lupus erythematosus, systemic

dermatomyositis (polymyositis) C. Dermatologic Diseases: Severe erythema multiforme, Stevens-

Johnson syndrome

D. Allergic States: Serum sickness

E. Ophthalmic Diseases: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

F. Respiratory Diseases: Symptomatic sarcoidosis G. Edematous State: To induce a diuresis or a remission of proteinuria in

the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

H. Any indication outside of the medically necessary indications above.

Rhinoplasty and Other Nasal Surgeries

Aug. 1, 2015

Changed policy title; previously

titled Rhinoplasty and Repair of Vestibular Stenosis

Revised coverage rational/indications for coverage:

Rhinoplasty for Nasal Vestibular Stenosis or Alar Collapse o Updated coverage criteria for

reconstructive/medically necessary treatment: Removed criterion

requiring “internal and/or external nasal valve compromise causes an anatomic mechanical nasal airway obstruction

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

enrollee’s plan specific documents. Indications for Coverage

Rhinoplasty for Nasal Vestibular Stenosis or Alar Collapse

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

external nasal valve compromise (see definition below), and

B. Internal valve compromise due to collapse of the upper lateral cartilage and/or external nasal valve compromise due to collapse of the alar (lower lateral) cartilage resulting in an anatomic mechanical nasal airway obstruction that is a primary contributing factor for obstructed nasal


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REVISED


Rhinoplasty and Other Nasal Surgeries (continued)

Aug. 1, 2015

and is a primary contributing factor for obstructed nasal breathing (e.g., large cutaneous defect,

malignancy or trauma)” Added criterion requiring

“internal valve compromise due to collapse of the upper lateral cartilage and/or external nasal valve

compromise due to collapse of the alar (lower lateral) cartilage resulting in an anatomic mechanical nasal airway obstruction that is a

primary contributing

factor for obstructed nasal breathing”

Rhinoplasty for Congenital Anomalies o Reworded coverage criteria

for reconstructive/medically

necessary treatment to indicate rhinoplasty is considered reconstructive when performed for a nasal

deformity associated with congenital craniofacial anomalies including, but not

limited to Pierre Robin, Apert Syndrome, Fraser Syndrome, Binder Syndrome, Goldenhar Syndrome, Nasal dermoids, Tessier Nasal Cleft (most commonly #1) or associated with a cleft lip or cleft palate

breathing. and C. Other causes have been eliminated as the primary cause of nasal

obstruction (e.g. sinusitis, allergic rhinitis, vasomotor rhinitis, nasal polyposis, adenoid hypertrophy, nasopharyngeal masses)

Rhinoplasty for Congenital Anomalies

The following are considered reconstructive and medically necessary when the following criteria are present: Rhinoplasty is considered reconstructive when performed for a nasal deformity associated with congenital craniofacial anomalies including, but not limited to Pierre Robin, Apert Syndrome, Fraser Syndrome, Binder

Syndrome, Goldenhar Syndrome, Nasal dermoids, Tessier Nasal Cleft (most commonly #1) or associated with a cleft lip or cleft palate. Septal Dermatoplasty (CPT 30620): Septal dermatoplasty is considered reconstructive when: A. There is a documented functional impairment (e.g. Obstruction, pain or

bleeding) due to diseased nasal mucosa, and

B. The functional impairment will be eliminated by a skin graft. Lysis Intranasal Synechia (CPT 30560): Lysis intranasal synechia is considered reconstructive when: A. There is a documented functional impairment (e.g. Obstruction, pain or

bleeding) due to intranasal synechia (adhesions/scar bands), and

B. The functional impairment will be eliminated by lysis of the synechia. Medical Necessity Plans: Please use the criteria above where applicable.

Documentation: Rhinoplasty or other nasal surgery documentation should include the evaluation and management note for the date of service and the note for the

day the decision to perform surgery was made. The enrollee’s medical record must contain, and be available for review on request, the following information: Physician office notes Radiologic imaging Photographs that document the nasal anomaly


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REVISED



Aug. 1, 2015

Septal Dermatoplasty (new to policy) o Added language to indicate

septal dermatoplasty (CPT code 30620) is considered

reconstructive when; There is a documented

functional impairment (e.g., obstruction, pain or bleeding) due to diseased nasal mucosa, and

The functional

impairment will be eliminated by a skin graft

Lysis Intranasal Synecha (new to policy) o Added language to indicate

lysis intranasal synechia (CPT

code 30560) is considered

reconstructive when; There is a documented

functional impairment (e.g., obstruction, pain or bleeding) due to intranasal synechia

(adhesions/scar bands), and

The functional impairment will be

eliminated by lysis of the synechia

Documentation (new to policy) o Added language to indicate

rhinoplasty or other nasal surgery documentation should include the evaluation and management note for the date of service and the note for the day the decision

Coverage Limitations and Exclusions

Cosmetic Procedures are excluded from coverage, including but not limited to: A. Procedures that correct an anatomical Congenital Anomaly without

improving or restoring physiologic function are considered Cosmetic

Procedures. The fact that a Covered Person may suffer psychological consequences or socially avoidant behavior as a result of an Injury, Sickness or Congenital Anomaly does not classify surgery (or other

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

B. Rhinoplasty, unless rhinoplasty criteria above are met. C. Any procedure that does not meet the reconstructive criteria above.

D. Rhinoplasty procedures performed to improve appearance. (check

enrollee’s plan specific document)


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REVISED



Aug. 1, 2015 to perform surgery was made; the enrollee’s medical record must contain, and be available for review on request, the following

information: Physician office notes Radiologic imaging Photographs that

document the nasal anomaly

Updated definitions; added

definition of: o External nasal valve o Septal dermatoplasty o Synechia

Sodium

Hyaluronate

Aug. 1, 2015

Revised coverage rationale;

removed notation indicating the criterion requiring history of

inadequate response or intolerance to prior therapy does not apply to New Jersey plan members

Updated list of applicable ICD-10

diagnosis codes (preview draft effective 10/01/15); removed M26.61

Updated list of applicable ICD-10

procedure codes (preview draft

effective 10/01/15); added 3E0U33Z, 3E0U36Z, 3E0U37Z, 3E0U3SF, 3E0U3BZ, 3E0U3HZ,3E0U3KZ, 3E0U3NZ, and 3E0U3TZ

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

Pre-certification is not required in the office for J7323, J7325, 20605 and

20610. Initial Course of Administration/Treatment I. Treatment with intra-articular injections of sodium hyaluronate is

proven and medically necessary for pain due to osteoarthritis of the knee when administered according to U.S. Food and Drug Administration (FDA) labeled indications. FDA Labeling*:

Euflexxa 3 injections

Gel One 1 injection

Hyalgan 5 injections

Monovisc 1 injection

Orthovisc 3 to 4 injections

Supartz 3 to 5 injections

Synvisc 3 injections

Synvisc One 1 injection

*Hyaluronic acid preparations for the treatment of pain due to


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REVISED


Sodium Hyaluronate (continued)

Aug. 1, 2015

osteoarthritis of the knee are deemed therapeutically equivalent. The UnitedHealth Group National Pharmacy and Therapeutics Committee has defined therapeutically equivalent, products that can be expected to produce essentially the same therapeutic outcome and toxicity.

A. Euflexxa, and Synvisc or Synvisc-One (J7323, J7325): Pre-

certification is not required in the office for J7323 and J7325. Oxford considers use of intra-articular hyaluronan injections, Euflexxa (1 % sodium hyaluronate), and Synvisc (Hylan G-F 20) or Synvisc-One (Hylan G-F 20), proven and medically necessary for members with osteoarthritis of the knee who meet all of the following criteria: 1. The member has documented symptomatic osteoarthritis of the

knee; and I. The member reports pain which interferes with functional

activities (e.g., ambulation, prolonged standing); and II. The member has not responded adequately to

conservative therapy which may include physical therapy or pharmacotherapy (e.g., non-steroidal anti-inflammatory

drugs [NSAIDs], acetaminophen and/or topical capsaicin

cream) or injection of intra-articular steroids and such therapy has not resulted in functional improvement after at least 3 months, or the member is unable to tolerate conservative therapy because of adverse side effects; and

III. The pain cannot be attributed to other forms of joint disease; and

IV. There are no contraindications to the injections (e.g., active joint infection, bleeding disorder).

B. Hyalgan and Supartz (J7321), Orthovisc (J7324), Gel-One

(J7326), and Monovisc (J3490): Pre-certification is required in all settings for J7321, J7324, J7326, and J3490. Oxford considers use of intra-articular hyaluronan injections, Hyalgan

(sodium hyaluronate) and Supartz (sodium hyaluronate), Orthovisc (high molecular weight form of hyaluronic acid), Gel-One (hyaluronan), and Monovisc (cross-linked sodium hyaluronate) proven and) medically necessary for members with osteoarthritis of the knee who have met the criteria above and: 1. The member has a history of failure, contraindication or

intolerance documented trial and failure to Synvisc, Synvisc-One


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REVISED



Aug. 1, 2015

or Euflexxa.

Note: There is no evidence that use of one particular intra-articular hyaluronan product is considered to be of greater effectiveness over another.

II. Intra-articular injections of sodium hyaluronate are proven and

medically necessary for temporomandibular joint (TMJ) disc

displacement and osteoarthritis.

III. Treatment with sodium hyaluronate preparations is unproven and not medically necessary, for any other indication not listed above as medically necessary including but not limited to:

Pain due to osteoarthritis in any joint other than the knee or TMJ

Any other form of arthritis [including rheumatoid arthritis (RA)

Patello-femoral syndrome

Chondromalacia of the knee

Following total or partial knee joint replacement

Increase in viscoelasticity of synovial fluid after sodium hyaluronate injection has not been demonstrated in patients with rheumatoid arthritis, and it has not been determined whether sodium hyaluronate is protective

in joints affected by rheumatoid arthritis. Further studies are needed to determine the safety and durability of such treatment for patello-femoral syndrome and chondromalacia of the knee and whether it significantly delays the need for more invasive treatment, e.g. surgery, joint replacement or arthroplasty. There are no clinical studies evaluating the use of sodium hyaluronate in persons following total or partial knee joint replacement surgery.

IV. Treatment with hyaluronic acid gel preparations to improve the skin's contour and/or reduce depressions due to acne, scars, injury or wrinkles is considered cosmetic and is therefore excluded from coverage. The use of sodium hyaluronate preparations to improve the skin's contour and/or reduce depressions in the skin due

to acne, scars, injury or wrinkles improves physical appearance but does not remove or improve a functional impairment of the skin.

Subsequent Course of Administration/Treatment


Oxford


REVISED



Aug. 1, 2015 I. Repeated courses of intra-articular sodium hyaluronan injections

of the knee may be considered proven and medically necessary under the following conditions:

Documentation of significant pain relief achieved with the prior course

of injections; and

Pain has recurred; and

At least six (6) months have passed since the prior course of treatment.

Specialty

Medication Administration - Site of Care Review Guidelines

Oct. 1, 2015

Changed policy title; previously

titled Site of Care Review Guidelines for Medical Necesssity of Hospital Outpatient Facility Specialty Medication Infusion

Added reference links to related policies titled: o Actemra® (Tocilizumab)

o Entyvio® (Vedolizumab) o Orencia® (Abatacept) o Remicade ® (Infliximab)

Revised coverage rationale: o Added language to indicate

alternative sites of care, such

as non-hospital outpatient infusion, physician office, ambulatory infusion or home infusion services are well accepted places of service for medication infusion therapy; if

a patient does not meet

criteria to for outpatient hospital facility infusion, alternative sites of care may be used

o Updated list of specialty medications requiring healthcare provider

administration that the policy

Introduction

This policy addresses the criteria for consideration of allowing hospital outpatient facility specialty medication infusion service and claim submission for hospital based services with CMS/AMA Place of Service code 22 Outpatient Hospital. Alternative sites of care, such as non-hospital outpatient infusion, physician office, ambulatory infusion or home infusion services are well accepted places of service for medication infusion therapy. If a patient does not meet criteria to for outpatient hospital facility infusion, alternative

sites of care may be used. This policy applies to these specialty medications that require healthcare provider administration: Abatacept (Orencia®) Eculizumab (Soliris®)

Infliximab (Remicade® lyophilized concentrate for intravenous use) Tocilizumab (Actemra® injection for intravenous use) Vedolizumab (Entyvio®) Medical Necessity Criteria for Site of Care Selection Outpatient hospital facility-based intravenous medication infusion is

medically necessary for Members who meet any of the following criteria:

Medically unstable based upon submitted clinical history; or Initial medication infusion of or re-initiation after more than 6 months

following discontinuation of therapy; or Previous experience of a severe adverse event following infusion.

Examples include but are not limited to anaphylaxis, seizure, thromboembolism, myocardial infarction, renal failure; or

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

medications; or


Oxford


REVISED


Specialty Medication Administration - Site of Care Review Guidelines

(continued)

Oct. 1, 2015 applies to; added: abatacept (Orencia®) infliximab (Remicade®

lyophilized concentrate for intravenous use)

tocilizumab (Actemra®

injection for intravenous use)

vedolizumab (Entyvio®) Updated clinical evidence:

o Added language to indicate the ACR Practice Management

Drug Safety on Remicade states that ‘it is an infusible medication that has been approved for home IV therapy, hospital outpatient administration or physician

office administration’

o Added information pertaining to Infliximab study findings

Removed lists of applicable HCPCS, ICD-9 and ICD-10 codes

Physically and/or cognitively impaired and no home caregiver available. Additional information: Medical necessity criteria for administration of intravenous infusion therapy at home are addressed in MCG™ Care Guidelines, 19th edition, 2015, Home Infusion Therapy, CMT: CMT-

0009(SR).

Tysabri

(Natalizumab)

Aug. 1, 2015

Revised coverage rationale for

induction therapy: o Removed notation indicating

the criterion requiring history of inadequate response or

intolerance to prior therapy

does not apply to New Jersey plan members

o Updated list of examples of TNF–inhibitors: Removed Enbrel

(etanercept) Added certolizumab pegol

(Cimzia) Revised benefit considerations:

Natalizumab (Tysabri®) is proven and medically necessary when all of the

following are met: 1. Diagnosis of relapsing forms of multiple sclerosis. 2. Baseline cranial MRI performed prior to initial administration 3. Used as monotherapy

Natalizumab is proven and medically necessary for inducing and maintaining clinical response and remission in members with moderate to

severe Crohn's Disease (CD) who meet one of the following criteria: For Induction Therapy when all of the following criteria are met: 1. Evidence of inflammation (e.g., elevated C-reactive protein [CRP],

elevated erythrocyte sedimentation rate, presence of fecal leukocytes) 2. History of inadequate response or intolerance to conventional Crohn’s

disease therapies and inhibitors of TNF-α. Conventional Crohn’s disease


Oxford


REVISED


Tysabri (Natalizumab) (continued)

Aug. 1, 2015

o Added language for Essential Health Benefits for Individual and Small Group plans to indicate: For plan years beginning on

or after January 1, 2014,

the Affordable Care Act of 2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide

coverage for ten categories of Essential Health Benefits (“EHBs”)

Large group plans (both self-funded and fully insured), and small group

ASO plans, are not subject

to the requirement to offer coverage for EHBs; however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as

maternity benefits), the ACA requires all dollar limits on those benefits to be removed on all

Grandfathered and Non-Grandfathered plans

The determination of which

benefits constitute EHBs is made on a state by state basis; as such, when using this guideline, it is important to refer to the member specific benefit document to determine

therapies may include aminosalicylates (such as mesalamine and sulfasalazine), corticosteroids, immunomodulators (such as azathioprine, 6-mercaptopurine, and methotrexate) and TNF-inhibitors [ e.g., infliximab (Remicade®), adalimumab (Humira®), or certolizumab pegol (Cimzia®)].

3. Patient is not receiving concomitant immunosuppressants (e.g., 6-MP,

azathioprine, cyclosporine, or methotrexate) OR TNF-inhibitors [e.g.,

Humira (adalimumab), or Remicade (infliximab), or certolizumab pegol (Cimzia®)].

or

For Maintenance Therapy when all of the following criteria are met: 1. Diagnostic and/or clinical documentation (e.g. improved disease activity

index) that indicates patient has experienced clinical benefit from

receiving (induction) Tysabri therapy by week 12. 2. Patients with Crohn’s disease who start natalizumab while on chronic oral

corticosteroids must discontinue chronic steroids within 6 months of starting natalizumab therapy or natalizumab therapy should be

discontinued. 3. Patient is not receiving concomitant immunosuppressants (e.g., 6-MP,

azathioprine, cyclosporine, or methotrexate) OR TNF-inhibitors [e.g.,

Enbrel (etanercept), Humira (adalimumab), or Remicade (infliximab)]. Natalizumab is unproven and not medically necessary for the treatment of other conditions or diseases including types of MS other than relapsing forms. Statistically robust randomized controlled trials are needed to address the issue of whether natalizumab has sufficient superiority in clinical efficacy

compared to other available treatments to justify the substantial inherent risk in its use.


Oxford


REVISED


Tysabri (Natalizumab) (continued)

Aug. 1, 2015 benefit coverage o Removed language indicating

the State of New Jersey prohibits requiring failed prior therapy or intolerance to

therapy as a requirement for

coverage Updated supporting information

to reflect the most current clinical

evidence and references

Xolair (Omalizumab)

Aug. 1, 2015

Revised coverage rationale: o Added language to indicate if

service is “proven” or

“unproven” to applicable medically necessary/not medically necessary statement

o Removed notation indicating

the criterion requiring history of inadequate response or

intolerance to prior therapy does not apply to New Jersey plan members

Revised benefit considerations:

o Added language for Essential Health Benefits for Individual and Small Group plans to indicate: For plan years beginning on

or after January 1, 2014,

the Affordable Care Act of

2010 (ACA) requires fully insured non-grandfathered individual and small group plans (inside and outside of Exchanges) to provide coverage for ten categories of Essential Health Benefits

(“EHBs”)

Omalizumab (Xolair®) for subcutaneous use is proven and medically necessary for the following: 1. Adults and adolescents with moderate to severe persistent

asthma who meet ALL of the following criteria

A. Age 12 years or older B. Have a positive skin test or in vitro reactivity to a perennial

aeroallergen C. Symptoms inadequately controlled with inhaled corticosteroids D. Have a baseline plasma immunoglobulin E (IgE) level between 30 and

1500 IU/mL

*Additional information to support medical necessity review: Omalizumab is medically necessary for the treatment of adults and adolescents with moderate to severe persistent asthma when all of the following criteria are met: A. Age 12 years or older; and B. Diagnosis of moderate to severe persistent uncontrolled asthma as

defined by one of the following:

a. Daily asthmatic symptoms b. Daily use of inhaled short-acting beta2-agonist c. Exacerbations affect/limit activity d. Exacerbations (requiring oral systemic corticosteroids) ≥ 2 times

a year e. Nighttime awakening more than once per week

f. Forced expiratory volume in one second (FEV1) or peak expiratory flow PEF) ≤80% of predicted level

g. Measures of asthma control indicate uncontrolled asthma (e.g.,


Oxford


REVISED


Xolair (Omalizumab) (continued)

Aug. 1, 2015

Large group plans (both self-funded and fully insured), and small group ASO plans, are not subject to the requirement to offer

coverage for EHBs;

however, if such plans choose to provide coverage for benefits which are deemed EHBs (such as maternity benefits), the ACA requires all dollar

limits on those benefits to be removed on all Grandfathered and Non-Grandfathered plans

The determination of which benefits constitute EHBs is

made on a state by state

basis; as such, when using this guideline, it is important to refer to the member specific benefit document to determine benefit coverage

o Removed language indicating the State of New Jersey prohibits requiring failed prior therapy or intolerance to

therapy as a requirement for coverage

Updated list of ICD-10 diagnosis

codes (preview draft effective 10/01/15); removed L50.0, L50.1 and L50.9

Updated supporting information

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

Asthma Control Test [ACT] score ≤19) and C. Baseline (pre-omalizumab treatment) serum total IgE level ≥ 30

IU/mL and ≤ 1500 IU/mL; and D. Positive skin test or in vitro reactivity to a perennial aeroallergen;

and

E. Documented failure (e.g., emergency room visit or hospitalization for asthma exacerbation, need for oral steroid burst) of at least 3 months to regular/routine treatment with one of the following: a. One combination inhaled corticosteroid/long-acting beta2-agonist

product [e.g., (fluticasone propionate/salmeterol (Advair®),mometasone/formoterol (Dulera®),),

budesonide/formoterol (Symbicort®)]; or b. Combination therapy including both of the following:

i. One inhaled corticosteroid at the maximum dosage [e.g.., fluticasone propionate (Flovent®), budesonide (Pulmicort®), beclomethasone dipropionate (QVAR®)]; and

ii. One long-acting beta2-agonist [e.g., formoterol fumarate

(Foradil®), salmeterol xinafoate Serevent®)] ;

and F. Prescribed by or in consultation with an allergist/immunologist or

pulmonologist

2. Omalizumab is proven and medically necessary as add-on therapy in children with severe persistent allergic asthma when all of the

following criteria are met: A. Age 6 years to less than 12 years; and B. Diagnosis of severe persistent uncontrolled asthma as defined by one

of the following:

a. Frequent daytime symptoms b. Nighttime awakenings c. Use of short-acting beta2-agonist several times per day for

symptom control d. Exacerbations limit/affect daily activity e. Exacerbations (requiring use of oral systemic corticosteroids) ≥

2/year; and C. Baseline (pre-omalizumab treatment) serum total IgE level ≥ 30

IU/mL and ≤ 1500 IU/mL; and


Oxford


REVISED



Aug. 1, 2015

D. Documented failure (e.g., emergency room visit or hospitalization for asthma exacerbation, need for oral steroid burst) of at least 3 months to regular/routine treatment with one of the following: a. One combination inhaled corticosteroid/long-acting beta2-agonist

product [e.g., fluticasone propionate/salmeterol (Advair®),

mometasone/formoterol (Dulera®), budesonide/formoterol

(Symbicort®)]; or b. Combination therapy including both of the following:

i. One inhaled corticosteroid at the maximum dosage [e.g., fluticasone propionate (Flovent®), budesonide (Pulmicort®), beclomethasone dipropionate (QVAR®)]; and

ii. One long-acting beta2-agonist [e.g., formoterol fumarate

(Foradil®), salmeterol xinafoate (Serevent®)]; and E. Prescribed by or in consultation with an allergist/immunologist or

pulmonologist 3. Omalizumab is proven and medically necessary in chronic

urticaria in adults and adolescents who meet both of the

following criteria: A. Age 12 years or older; and B. Continues to remain symptomatic despite H1 antihistamine [e.g.,

cetirizine (Zyrtec), fexofenadine (Allegra)] treatment. Additional information to support medical necessity review: Omalizumab is medically necessary for treatment of chronic urticaria in

adults and adolescents when all of the following criteria are met: A. Age 12 years or older; and B. One of the following:

a. *Patient remains symptomatic despite at least a 2-week trial of,

or history of contraindication or intolerance to, two H1-antihistamines [e.g., Allegra (fexofenadine), Benadryl (diphenhydramine), Claritin (loratadine)]*; or

b. *Patient remains symptomatic despite at least a 2-week trial of, or history of contraindication or intolerance to both of the following taken in combination: i. Second generation H1-antihistamine [e.g., Allegra

(fexofenadine), Claritin (loratadine), Zyrtec (cetirizine)]; and ii. One of the following:

1. Different second generation H1-antihistamine [e.g.,


Oxford


REVISED



Aug. 1, 2015 Allegra (fexofenadine), Claritin (loratadine), Zyrtec (cetirizine)]

2. First generation H1-antihistamine[e.g., Benadryl (diphenhydramine), Chlor-Trimeton (chlorpheniramine), Vistaril (hydroxyzine)]*

3. H2-antihistamine [e.g., Pepcid (famotidine), Tagamet HB

(cimetidine), Zantac (ranitidine)] 4. Leukotriene modifier [e.g., Accolate (zafirlukast),

Singulair (montelukast), Zyflo (zileuton)] and C. Prescribed by or in consultation with an allergist/immunologist.

*Note: Patients 65 years of age and older in whom first generation H1-antihistamines are considered high risk medications to be avoided (e.g., Beers criteria, HEDIS) should be directed to try alternatives that are not considered high risk. Omalizumab is unproven and not medically necessary in the following:

1) Seasonal allergic rhinitis

2) Perennial allergic rhinitis 3) Atopic dermatitis 4) Peanut allergy

5) Acute bronchospasm or status asthmaticus

REPLACED

Policy Title Effective Date Summary of Changes

Cardiology

Procedures Requiring

Precertification

Jul. 1, 2015 Policy replaced; refer to the policy titled Cardiology Procedures Requiring Precertification for CareCore National

Arrangement for applicable coverage guidelines

Connecticut Clinical Trials

Aug. 1, 2015 Policy replaced; refer to the policy titled Clinical Trials for applicable coverage guidelines

Radiation Therapy Procedures Requiring Precertification

Jul. 1, 2015 Policy replaced; refer to the policy titled Radiation Therapy Procedures Requiring Precertification for CareCore National Arrangement for applicable coverage guidelines


Oxford


REPLACED


Radiology Procedures Requiring Precertification

Jul. 1, 2015 Policy replaced; refer to the policy titled Radiology Procedures Requiring Precertification for CareCore National Arrangement for applicable coverage guidelines


Oxford


NEW

Policy Title Effective Date Administrative Guidelines

New York Participating Provider Laboratory & Pathology Protocol

Sept. 1, 2015

The following procedures and responsibilities apply when a participating provider is treating a member enrolled in a New York (NY) product.

A. Participating Provider Using Participating Laboratories/Pathologists:

Participating providers are required to use an Oxford Participating laboratory and/or an Oxford participating

pathologist when collecting specimens in their office. If a participating laboratory or pathologist is used, the Laboratory & Pathology Services Consent Form is not required. If a participating provider is unable to locate a participating laboratory or pathologist, they must contact Oxford for assistance.

B. Participating Provider Responsibilities

Specific guidelines must be followed if a Participating provider is recommending the use of, making a referral to or involving a non-participating laboratory or pathologist in a member’s care. This includes the following:

o Specimens collected in the physician’s office for processing by a non-participating provider (on and off-site).

o Providing the member with a requisition form, prescription or other form to obtain laboratory or pathology services outside the physician office.

Prior to making the recommendation, involving or referring a member to a non-participating laboratory or pathologist, the Participating provider is required to:

1. Verbally discuss options and financial impact with the member.

a. The provider must review this policy and the Laboratory & Pathology Services Consent Form with the

Member. i. The discussion must explain participating alternatives and the reason for any referral to a non-

participating laboratory or pathologist.

ii. The discussion must include a conversation explaining the financial impact of using a non-participating lab or pathologist. Refer to the Coordinate the Member’s Care as directed by the Member section below for details.

iii. A copy of the completed and signed Laboratory & Pathology Services Consent Form must be provided

to the member.

b. The discussion must occur prior to the performance of any laboratory or pathology services including specimen collection.

c. The discussion must then be noted in the Member’s medical record.


Oxford


NEW



(continued)

Sept. 1, 2015

2. Obtain a Completed Laboratory & Pathology Services Consent Form:

a. The member will need to make a choice whether to use a participating or non-participating laboratory or pathologist, by marking their selected choice, signing and dating the Laboratory & Pathology Services Consent Form.

b. If the member:

i. Does Agree to the use of a non-participating laboratory or pathologist, refer to the Coordinate the Member’s Care as directed by the Member (bullet 3a) for additional details.

ii. Does Not Agree, refer to the Coordinate the Member’s Care as directed by the Member (bullet 3b) for additional details.

c. The signed and completed Laboratory & Pathology Services Consent Form must be kept on file by the Participating provider.

d. A separate Laboratory & Pathology Services Consent Form is required for each episode of laboratory care

when the Participating provider wants to refer to or involve a non-participating laboratory or pathologist in a member’s care.

e. The Laboratory & Pathology Services Consent Form will only be valid for 15 days from the date of member signature.

f. Oxford may request a copy of the completed Laboratory & Pathology Services Consent Form from the Participating provider in order to conduct standard business.

i. When requested, the Participating provider must provide a copy of the Laboratory & Pathology Services

Consent Form within 15 days of the request. ii. If a copy of the signed and completed Laboratory & Pathology Services Consent Form is not received

within 15 days of the request, the claim for the Evaluation & Management (E&M) service, from the office visit that generated the non-participating laboratory or pathology service will be reversed and denied administratively for failure to comply with this protocol.

iii. Any payment previously made for the E&M service will be subject to recovery. In these instances, the

Participating provider is prohibited from balance billing the member.

3. Coordinate the Member’s Care as Directed by the Member in the Laboratory & Pathology Services Consent Form

1. If the Member agrees to the use of Non-participating Laboratory or Pathologist:

Ensure that the member understands the financial obligations of using a non-participating laboratory or pathologist.

- For Members with out of network benefits: Non-participating laboratory and pathology claims will be paid at the out-of-network benefit level. Out-of-network cost shares and deductibles will apply. In addition, members may be responsible to the non-participating laboratory or pathologist


Oxford


NEW



(continued)

Sept. 1, 2015

for any amount above the amount paid by the health plan, as determined by the member’s out-of-network benefit; OR

- For Members with only in-network benefits: Non-participating laboratory and pathology claims will be denied because the member has no coverage for services provided by non-participating providers. Members will therefore be responsible for the entire cost of the service(s).

2. If the Member does NOT agree to the use of Non-participating Laboratory or Pathologist:

If the participating provider is unable to locate a participating laboratory or pathologist, they must contact Oxford for assistance in locating one.

If the participating provider still wants to recommend the non-participating laboratory or pathologist, they must contact the health plan to request and initiate an in-Network Exception.

C. Financial Consequence for Non-Compliance by NY Participating Physicians

Oxford may request a copy of the completed Laboratory & Pathology Services Consent Form from the Participating provider (who is required to keep the form on file) in order to conduct standard business.

o When requested, the Participating physician must provide a copy of the Laboratory & Pathology Services

Consent Form within 15 days of the request. o If a copy of the completed Laboratory & Pathology Services Consent Form is not received within 15 days of the

request, the Evaluation & Management (E&M) code from the office visit, which generated the non-participating

laboratory or pathology referral, will be reversed and denied administratively for failure to comply with this protocol.

o Any payment previously made for the E&M service will be subject to recovery. In these instances, the

Participating provider is prohibited from balance billing the member.

UPDATED

Policy Title Effective Date Summary of Changes Administrative Guidelines

Autism Aug. 1, 2015 Updated list of applicable ICD-10

diagnosis codes (preview draft

effective 10/01/15) for Pervasive Developmental Disorder for CT Products and Other Developmental Disability for NJ Products; removed F84.0, F84.3, F84.5, F84.8, and F84.9

Refer to the policy for complete details on the coverage guidelines for

treatment of Autism.


Oxford


RETIRED


Laboratory Services Protocol

Jul. 1, 2015 Policy retired; refer to the 2015 Physician, Health Care Professional, Facility and Ancillary Provider Administrative Guide for applicable guidelines


Oxford

Reimbursement Policy Updates \

UPDATED

Policy Title Effective Date Summary of Changes Reimbursement Guidelines

Bilateral Procedures Policy

Jul. 1, 2015

Updated policy application language to indicate this policy applies to all network and non-network physicians and other qualified health care

professionals, including, but not

limited to, non-network authorized and percent of charge contract physicians and other qualified health care professionals

Bilateral Eligible List The Oxford Bilateral Eligible Procedures Policy List is developed based on the Centers for Medicare and Medicaid Services (CMS) National Physician Fee Schedule (NPFS) Relative Value File status indicators.

All codes in the NPFS with the "bilateral" status indicators "1" or "3" are

considered by Oxford to be eligible for bilateral services as indicated by the bilateral modifier 50. When a bilateral eligible code with a bilateral indicator of "1" is reported with modifier 50 and is subject to reductions under Multiple Procedures Policy, the

code will be eligible for reimbursement at 150% of the allowable amount not to exceed billed charges for a single procedure code, with one side reimbursed at 100% and the other side reimbursed at 50%. When other reducible procedure codes are reported on the same date of service, an additional multiple procedure reduction may or may not be applied to the line paid at 100% depending on whether another procedure code is ranked as

primary or not.

When a bilateral eligible code with a bilateral indicator of "3" is reported with modifier 50 and is not subject to reductions under the Multiple Procedure Policy, the code will be eligible for reimbursement at 100% of the allowable amount for each side for a sum of 200% of the allowable amount not to exceed billed charges.

For a list of procedure codes that are subject to multiple procedure reductions, see Oxford's Multiple Procedures Policy. Bilateral Eligible Procedures Policy List

CMS Files for Download

Multiple Procedure Reduction Eligible Bilateral Procedures on the Oxford Bilateral Eligible Procedures Policy List may be subject to multiple procedure reductions as defined in Oxford's Multiple Procedures Policy. In order to fully understand Oxford's reimbursement rules for eligible Bilateral Procedures, refer to the Multiple Procedures Policy in conjunction with this policy.

Bilateral Modifier (50)


Oxford


UPDATED


Bilateral Procedures Policy (continued)

Jul. 1, 2015

Modifier 50 identifies the same procedures that are performed as a bilateral service. The procedure should be billed on one line with modifier 50 and one unit with the full charge for both procedures. A procedure code submitted with modifier 50 is a reimbursable service as set forth in this policy only when it is listed on the Oxford Bilateral Eligible Procedures Policy List.

When a CPT or HCPCS code is reported with modifier 50 and the code is not listed on the Bilateral Eligible Procedures Policy List, the code will not be reimbursed. CPT or HCPCS codes with 'bilateral' or 'unilateral or bilateral' written in the description are not on Oxford's Bilateral Eligible Procedures Policy List and

will not be reimbursed with modifier 50. There are rare instances in which a bilateral service may be performed on multiple sites and not just bilaterally. In those instances, use modifier 59 Distinct Procedural Service or XS Separate Structure to report the additional units beyond the bilateral services performed indicating that the services

were performed on a different site or organ system. Medical record

documentation must support the use of modifier 59 or XS. Procedure Codes with the Term "Bilateral" in the Description When CPT or HCPCS codes with "bilateral" or "unilateral or bilateral" written in the description are reported, special consideration will be given when

reported with modifiers LT or RT. When a CPT or HCPCS procedure code exists for both a unilateral and a Bilateral Procedure, select the code that best represents the procedure. For

example: 40842 Vestibuloplasty; posterior, unilateral and 40843 Vestibuloplasty; posterior, bilateral.

Codes with "Bilateral" in the Description Policy List Consistent with CPT guidelines, if a unilateral procedure has not been defined by CPT or HCPCS and only a bilateral description of a procedure exists, report the code with "bilateral" in the description with modifier 52 (reduced services) when the procedure is performed unilaterally. For more information on reimbursement for reduced services, see Oxford's Reduced Services


Oxford


UPDATED



Jul. 1, 2015

policy. For Oxford purposes, when both modifiers LT and RT are reported separately for codes with "bilateral" in the description, only one charge will be eligible for reimbursement up to the respective Maximum Frequency per Day (MFD)

value as the procedure is inherently bilateral. For additional information,

refer to the Questions and Answers section, Q3A3. For more information on maximum frequency per day values, see Oxford's Maximum Frequency Per Day policy. When a procedure with "unilateral or bilateral" written in the description is performed unilaterally, then the CPT or HCPCS procedure code need not be

reported with modifier 52 since the procedure description already indicates that the service can be performed either unilaterally or bilaterally. For example: 31231 Nasal endoscopy, diagnostic, unilateral or bilateral (separate procedure). Codes with "Unilateral or Bilateral" in the Description Policy List

The use of modifiers LT or RT will be recognized as informational only when the procedure with "unilateral or bilateral" in description is performed on only one side. Consistent with CMS guidelines, when both modifiers LT and RT are reported separately on the same day by the Same Individual Physician or Other Health Care Professional, only one charge will be eligible for reimbursement up to the maximum frequency per day limit.

For maximum frequency per day limits, see Oxford's Maximum Frequency Per Day policy.

Modifier Definitions

Modifier Modifier Description

50

Bilateral Procedure Unless otherwise identified in the listings, bilateral procedures that are performed at the same session, should be identified by adding modifier 50 to the appropriate five digit code.

59 Distinct Procedural Service Under certain circumstances, it may be necessary to indicate


Oxford


UPDATED



Jul. 1, 2015 that a procedure or service was distinct or independent from other non-E/M services performed on the same day. Modifier 59 is used to identify procedures or services, other than E/M services, that are not normally reported together but are

appropriate under the circumstances. Documentation must support a different session, different procedure or surgery,

different size or organ system, separate incision or excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. However, when another already established modifier is appropriate it should be used

rather than modifier 59. Only if no more descriptive modifier is available and the use of modifier 59 best explains the circumstances should modifier 59 be used. Note: Modifier 59 should not be appended to an E/M service. To report a separate and distinct E/M service performed on the same date, see modifier 25.

XS Separate Structure A service that is distinct because it was performed on a separate organ/structure.

LT Left Side

RT Right Side

Care Plan Oversight Policy

Jul. 1, 2015 Updated policy application language to indicate this policy applies to all network and non-

network physicians and other qualified health care professionals, including, but not limited to, non-network

authorized and percent of charge contract physicians and other qualified health care

professionals

Refer to the policy for complete details on the reimbursement guidelines for Care Plan Oversight.

Co-Surgeons; Team Surgeon Policy

Jul. 1, 2015

Updated policy application language to indicate this policy applies to all network and non-network physicians and other

qualified health care

Co-Surgeon Services Modifier 62 identifies a Co-Surgeon involved in the care of a patient at surgery. Each Co-Surgeon should submit the same Current Procedural Terminology (CPT) code with modifier 62.


Oxford


UPDATED


Co-Surgeons; Team Surgeon Policy (continued)

Jul. 1, 2015

professionals, including, but not limited to, non-network authorized and percent of charge contract physicians and other qualified health care

professionals

Updated definitions; replaced definition of “surgical team” with “team surgeons”

For services included on the Co-Surgeon Eligible List, Oxford will reimburse Co-Surgeon services at 63% of the Allowable Amount to each surgeon subject to additional multiple procedure reductions if applicable (see Multiple Procedure Reduction section of the policy). The Allowable Amount is determined independently for each surgeon and is calculated from the

Allowable Amount that would be given to that surgeon performing the

surgery without a Co-surgeon. The reimbursable percentage amount (63%) of allowable is based on the rate adopted by the Centers for Medicare and Medicaid Services (CMS), which allows 62.5% of allowable to each Co-Surgeon. Exception: For New Jersey individual and small group plans, standard

reimbursement is based on the 80th percentile of Prevailing Healthcare Charges System (PHCS). Team Surgeon Services Modifier 66 identifies Team Surgeons involved in the care of a patient during surgery. Each Team Surgeon should submit the same CPT code with modifier

66.

Each Team Surgeon is required to submit written medical documentation describing the specific surgeon's involvement in the total procedure. For services included on the Team Surgeon Eligible List, Oxford will review each submission with its appropriate medical documentation and will make reimbursement decisions on a case-by-case basis.

Co-Surgeon and Team Surgeon Eligible Lists The Co-Surgeon and Team Surgeon Eligible List are developed based on the Centers for Medicare and Medicaid Services (CMS) National Physician Fee

Schedule (NPFS) Relative Value File status indicators. All codes in the NPFS with status code indicators "1" or "2" for "Co-Surgeons"

are considered by Oxford to be eligible for Co-Surgeon services as indicated by the co-surgeon modifier 62. Oxford applies the payment indicators for HCPCS codes G0412-G0415 when adjudicating CPT codes 27215-27218 for the purposes of this policy. All codes in the NPFS with the status code indicators "1" or "2" for "Team


Oxford


UPDATED


Co-Surgeons; Team Surgeon Policy (continued)

Jul. 1, 2015 Surgeons" are considered by Oxford to be eligible for Team Surgeon services as indicated by the team surgeon modifier 66. CMS Files for Download

Multiple Procedure Reductions

Multiple procedure reductions apply to Co-Surgeon and Team Surgeon claim submissions when one or more physicians are billing multiple CPT codes that are eligible for reductions. Refer to Oxford Multiple Procedures Policy for application of multiple procedure reductions. Assistant Surgeon and Co-Surgeon Services During the Same

Encounter Oxford follows CMS guidelines and does not reimburse for Assistant Surgeon services, as indicated by modifiers 80, 81, 82, or AS, for procedures where reimbursement has been provided for eligible Co-Surgeon services, using the same surgical procedure code, during the same encounter.

If a Co-Surgeon acts as an Assistant Surgeon in the performance of

additional procedure(s) during the same surgical session, the procedures are reimbursable services (if eligible per the Assistant Surgeon Eligible List) when indicated by separate procedure code(s) with modifier 80 or modifier 82 added, as appropriate. Simultaneous Bilateral Services

Simultaneous bilateral services are those procedures in which each surgeon performs the same procedure on opposite sides. Each surgeon should report the simultaneous bilateral procedures with modifiers 50 and 62. Assistant Surgeon services will not be reimbursed services in addition to the

simultaneous bilateral submission as described in the Assistant Surgeon and Co-Surgeon Services During Same Encounter section in this policy.

New Patient Visit Policy

Jul. 1, 2015

Updated policy application language to indicate this policy applies to all network and non-network physicians and other qualified health care professionals, including, but not

limited to, non-network

Refer to the policy for complete details on the reimbursement guidelines for New Patient Visits.


Oxford


UPDATED


New Patient Visit Policy (continued)

Jul. 1, 2015 authorized and percent of charge contract physicians and other qualified health care professionals

Split Surgical

Package Policy

Jul. 1, 2015

Updated policy application

language to indicate this policy applies to all network and non-network physicians and other qualified health care professionals, including, but not limited to, non-network

authorized and percent of charge contract physicians and other qualified health care professionals

Consistent with the Centers for Medicare and Medicaid Services (CMS),

Oxford considers the surgical care rendered by the Same Group Physician and/or Other Health Care Professional to include pre-operative management. Accordingly, in Split Surgical Package situations, the pre-operative and surgical care portions of the Surgical Package are combined by Oxford in the reimbursement of surgical codes appended with modifier 54. Preoperative care is not reimbursed separately. Postoperative care management may be

reimbursed separately when a physician or other health care professional who is not within the Same Group Practice as the operating physician provides the postoperative care as denoted by submission of the surgical code appended with modifier 55. Split surgical package situations will be reimbursed not to exceed 100% of

the total global surgical allowable amount, and are reimbursable at the percentages indicated:

Modifier Modifier Description Percentage

54 Surgical Care Only (includes preoperative

and surgical care management) 80%

55 Postoperative Management only 20%

56 Preoperative Management only 0%

TOTAL 100%

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