september 2017 medical policy update · medical policy update september 2017 3 coverage criteria...

Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association.Note: This publication may contain certain administrative requirements, policies, procedures, or other similar requirements of Highmark Inc. (or changesthereto) which are binding upon Highmark Inc. and its contracted providers. Pursuant to their contract, Highmark Inc. and such providers must comply

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

Coverage Criteria Revised for Golimumab (Simponi, Simponi Aria)................................................................... 2Change in Policy Position for In Vitro Chemoresistance and Chemosensitivity Assays .................................. 10Revised Criteria for Electromyography (EMG) ................................................................................................. 11

Contents.......................................................................................................................................................... 23

Coverage Criteria Revised for Certolizumab (Cimzia)

Highmark Blue Shield has revised the clinical criteria for certolizumab (Cimzia) to includetwo additional drug products; (tocilizumab (Actemra®) subcutaneous and tofacitinib(Xeljanz®, Xeljanz® XR), for step therapy for Rheumatoid Arthritis. Two additional drugproducts; ustekinumab (Stelara®) subcutaneous, and secukinumab (Cosentyx®), for steptherapy for Psoriatic Arthritis. And one additional drug product; secukinumab (Cosentyx)for step therapy for Ankylosing Spondylitis before the use of certolizumab (Cimzia). Thepatient will still only be required to have had an adequate trial or experienced intoleranceto at least two (2) of the preferred biologic products.

This new criteria will apply to both professional provider and facility claims. The effectivedate is September 4, 2017.

Place of Service: Outpatient

Please refer to Medical Policy I-27, Certolizumab (Cimzia) for additional information.

In This Issue

September 2017

Policy

Medical Policy Update September 2017

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Courtesy Update for Tocilizumab (Actemra)

Highmark Blue Shield has revised clinical criteria for Tocilizumab (Actemra®). Therevised policy will apply to both professional provider and facility claims. The effectivedate was September 4, 2017.


Tocilzumab subcutaneous (SQ) may be considered medically necessary when theindividual meets the following:

• Inadequate response, intolerance, or contraindication to one (1) or more non-biologic disease-modifying antirheumatic drugs (DMARDs) (i.e., methotrexate,leflunomide, sulfasalazine, hydroxychloroquine, or cyclosporine).

Please refer to Medical Policy I-31, Tocilizumab (Actemra®) for additional information.

Criteria Updated for Golimumab (Simponi, Simponi Aria)

Highmark Blue Shield has revised clinical criteria for Golimumab (Simponi®, SimponiAria®). The revised policy will apply to both professional provider and facility claims.The effective date is November 27, 2017.

Golimumab (Simponi) subcutaneous injection (SQ):

Rheumatoid Arthritis (RA)

• Golimumab SQ is used for the treatment of moderately to severely active RA incombination with methotrexate; and

• Has or had an adequate trial or experienced intolerance to at least two (2) of thepreferred biologic products, which include adalimumab (Humira®) , etanercept(Enbrel®), tocilizumab (Actemra®) subcutaneous, and tofacitinib (Xeljanz®,Xeljanz® XR).

Psoriatic Arthritis

• Golimumab SQ is used for the treatment of active psoriatic arthritis alone or incombination with methotrexate; and

• Has or had an adequate trial or experienced intolerance to at least two (2) of thepreferred biologic products, which include adalimumab (Humira) , etanercept(Enbrel), ustekinumab (Stelara) subcutaneous, and secukinumab (Cosentyx®).

Ankylosing Spondylitis

• Golimumab SQ is used for the treatment of active ankylosing spondylitis; and• Has or had an adequate trial or experienced intolerance to at least two (2) of the

preferred biologic products, which include adalimumab (Humira), etanercept(Enbrel), and secukinumab (Cosentyx).


Please refer to Medical Policy I-35, Golimumab (Simponi®, Simponi Aria®) foradditional information.


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Coverage Criteria Revised for Ustekinumab (Stelara)

Highmark Blue Shield has revised the clinical criteria for Ustekinumab (Stelara®)

Ustekinumab (Stelara) subcutaneous (SQ) may be considered medically necessary totreat individuals with moderately to severely active Crohn’s disease when ONE of thefollowing are met:

• Treatment with at least two immunosuppressants (e.g. corticosteroids,azathioprine, 6-mercaptopurine, or methotrexate) was ineffective or not tolerated;or immunosuppressants are contraindicated; or

• The patient received a single induction dose of Stelara IV and achieved clinicalresponse or remission; or

• Treatment with adalimumab (Humira) for the treatment of Crohn’s disease wasineffective or not tolerated.

Ustekinumab (Stelara) intravenous (IV) may be considered medically necessary to treatindividuals with moderately to severely active Crohn’s disease who have failed or wereintolerant to the following treatment:

• Immunomodulators or corticosteroids, but never failed a tumor necrosis factor(TNF) blocker; or

• One or more TNF blocker.

The use of ustekinumab (Stelara) for any other indication or in combination with any otherbiologic DMARD (e.g. Humira, Remicade, Cimzia, etc.) is considered experimental/investigational, and therefore, not covered because its effectiveness for these indicationshas not been established.

This new criteria will apply to both professional provider and facility claims. The effectivedate is November 27, 2017.


Please refer to Medical Policy I-37, Ustekinumab (Stelara®) for additional information.

Coverage Criteria Revised for Carfilzomib (Kyprolis)

Highmark Blue Shield has revised coverage criteria for carfilzomib (Kyprolis®) based onthe FDA approved indications and National Comprehensive Cancer Network (NCCN)recommendations.



Please refer to Medical Policy I-41, Carfilzomib (Kyprolis®) for additional information.


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Coverage Criteria Revised for Pemetrexed (Alimta)

Highmark Blue Shield has revised the clinical criteria for pemetrexed (Alimta®) based onthe FDA approved indications and National Comprehensive Cancer Network (NCCN)recommendations.



Please refer to Medical Policy I-74, Pemetrexed (Alimta®) for additional information.

Coverage Criteria Revised for Abatacept (Orencia) IV and SC

Highmark Blue Shield has revised the clinical criteria for abatacept (Orencia®) IV and SC.

Abatacept SC may be considered medically necessary for the treatment of active psoriaticarthritis when the individual has a history of beneficial response to abatacept SC; or

When ALL of the following indications are met:

• Abatacept (Orencia) SC is to be used in the treatment of adults with activepsoriatic arthritis; and

• Treatment with at least one nonbiologic DMARD (e.g. methotrexate, leflunomide,sulfasalazine, hydroxychloroquine, or cyclosporine) was ineffective or nottolerated, or all nonbiologic DMARDs are contraindicated; and

• Treatment with at least TWO of the following preferred products was ineffective ornot tolerated, or ALL of these preferred products are contraindicated:

o adalimumab (Humira©)o etanercept (Enbrel©)o ustekinumab (Stelara©)o secukinumab (Cosentyx®)

Juvenile Idiopathic Arthritis (JIA)/Juvenile Rheumatoid Arthritis (JRA)Abatacept (Orencia) SC may be considered medically necessary for the treatment ofmoderately to severely active JIA/JRA when the individual has a history of beneficialresponse to abatacept SC; or

When ALL of the following indications are met:

• Abatacept (Orencia) SC is to be used for reducing the signs and symptoms ofmoderately to severely active JIA/JRA in patients greater than or equal to 2 yearsof age; and

• Treatment with adalimumab (Humira) and etanercept (Enbrel) has been ineffectiveor not tolerated, or both of these preferred products are contraindicated; and

• Treatment with at least TWO of the following preferred products was ineffective ornot tolerated, or all of these preferred products are contraindicated:

o adalimumab (Humira)o etanercept (Enbrel)o ustekinumab (Stelara)o secukinumab (Cosentyx)


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Please refer to Medical Policy I-90, Abatacept (Orencia®) IV and SC for additionalinformation.

Coverage Criteria Revised for Radium Ra 223 Dichloride for Treatment ofProstate Cancer

Highmark Blue Shield has revised coverage criteria for Radium Ra 223 Dichloride fortreatment of prostate cancer.

The following criteria requirements have been added to the policy in addition to theexisting criteria.

• Prior to the initial dose, the individual must have an absolute neutrophil countgreater than or equal to 1.5X109/L, platelet count greater than or equal to100X109/L, and a hemoglobin greater than or equal to 10g/dL; and

• Prior to the subsequent doses, patients must have absolute neutrophil countgreater than or equal to 1X109/L and platelet count greater than or equal to50X109/L; and

• Radium RA 223 dichloride should be discontinued if a delay of 6-8 weeks does notresult in return of blood counts to these levels.



Please refer to Medical Policy I-97, Radium Ra 223 Dichloride for Treatment of ProstateCancer for additional information.


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Coverage Criteria and Policy Title Revised for PD-1 and PD-L1 BlockingAntibodies

Highmark Blue Shield has established additional criteria for oncologic indications for PD-1blocking antibodies. The revised criteria will apply to both professional provider andfacility claims. The effective date is November 27, 2017.


The following Oncologic PD-1 Blocking Antibodies have been added:• Avelumab (Bavencio)

• Durvalumab (Imfinzi)

New indications have been added for the following:• Pembrolizumab (Keytruda)• Nivolumab (Opdivo)• Atezolizumab (Tecentriq)

Please refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodiesfor additional information.

Coverage Criteria Established for Octreotide acetate (Sandostatin,Sandostatin LAR) and Lanreotide (Somatuline Depot)

Highmark Blue Shield has established coverage criteria for octreotide acetate(Sandostatin, Sandostatin LAR) and Lanreotide (Somatuline Depot).

Octreotide acetate (Sandostatin) may be considered medically necessary for ANY ofthe following indications:

• Acromegaly for patients who have had an inadequate response to or cannotbe treated with:

o Surgical resection; oro Pituitary irradiation; oro Bromocriptine mesylate at maximally tolerated doses; or

• Severe diarrhea and /or flushing episodes associated with metastatic carcinoidtumors; or

• Profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP)secreting tumors; or

• Central Nervous System Cancers – Meningiomas when used as:o Treatment for surgically inaccessible recurrent or progressive

meningiomas when further radiation is not possible; or• Neuroendocrine Tumors - Adrenal Gland Tumors:

o For symptom control if somatostatin receptor scintigraphy is positive inpatients with non-adrenocorticotropic hormone (ACTH)-dependentCushing's syndrome with tumors less than 4 cm, benign imagingcharacteristics, and abnormal contralateral gland and symmetriccortisol production; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, andThymus when used as:

o Primary treatment for unresected primary gastrinoma; or


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o Management of locoregional unresectable disease and/or distantmetastases as a single agent or in combination with other systemictherapies; if disease progression, treatment with octreotide may becontinued in combination with any of the subsequent treatment options;or

o Treatment of underlying Zollinger-Ellison syndrome; oro Prophylactic treatment prior to surgery for gastrinoma; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when usedas:

o Treatment of symptoms related to hormone hypersecretion; if diseaseprogression, treatment with octreotide may be continued in combinationwith any of the subsequent treatment options; or

• Thymomas and Thymic Carcinomas when used as second-line therapy with orwithout prednisone; or

• Poorly Differentiated (High Grade)/Large or Small Cell for symptom control ifsomatostatin scintigraphy positive; or

• Acquired immune deficiency syndrome (AIDS) - treatment of severe secretorydiarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin ormetronidazole) or anti-motility agents (e.g., loperamide or diphenoxylate andatropine) have become ineffective; or

• Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g.,nausea, pain, vomiting) of inoperable bowel obstruction in persons withterminal cancer; or

• Amelioration of volume depletion from enterocutaneous fistulae; or• Prevention and treatment of pancreatic fistulas following pancreatic surgery; or• Bleeding gastroesophageal (GE) varices when BOTH of the following are met:

o GE varices are associated with liver disease; ando Octreotide acetate is used in combination with endoscopic therapy (that

is, band ligation or sclerotherapy) or alone if endoscopic therapy is notimmediately available; or

• Chemotherapy or radiation-induced diarrhea that is unresponsive toconventional antidiarrheal medications (e.g., diphenoxylate and atropine orloperamide).

Octreotide acetate (Sandostatin LAR) may be considered medically necessary forANY the following indications:

• Acromegaly for patients who have had an inadequate response to or cannotbe treated with:


• Severe diarrhea and/or flushing episodes associated with metastatic carcinoidtumors; or


• Central Nervous System Cancers - Meningiomas when used as:o Treatment for surgically inaccessible recurrent or progressive

meningiomas when further radiation is not possible; or• Neuroendocrine Tumors - Adrenal Gland Tumors:

o For symptom control if somatostatin receptor scintigraphy is positive inpatients with non-adrenocorticotropic hormone (ACTH)-dependent


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Cushing's syndrome with tumors less than 4 cm, benign imagingcharacteristics, and abnormal contralateral gland and symmetriccortisol production; or


o Primary treatment for unresected primary gastrinoma; oro Management of locoregional unresectable disease and/or distant

metastases as a single agent or in combination with other systemictherapies; if disease progression, treatment with octreotide may becontinued in combination with any of the subsequent treatment options;or

o Treatment of underlying Zollinger-Ellison syndrome; oro Prophylactic treatment prior to surgery for gastrinoma; oro Treatment of carcinoid syndrome when used as:

As a single agent; or In combination with telotristat for persistent diarrhea due to

poorly controlled carcinoid syndrome; or In combination with subsequent treatment options for persistent

symptoms such as flushing or diarrhea; or• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used

as:o Treatment of symptoms related to hormone hypersecretion; if disease

progression, treatment with octreotide may be continued in combinationwith any of the subsequent treatment options; or

o For tumor control in patients with unresectable locoregional diseaseand/or metastatic disease and clinically significant tumor burden orclinically significant progression if not already given; or



• Acquired immune deficiency syndrome (AIDS) - treatment of severe secretorydiarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin ormetronidazole) or anti-motility agents (e.g., loperamide or diphenoxylate andatropine) have become ineffective; or

• Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g.,nausea, pain, vomiting) of inoperable bowel obstruction in persons withterminal cancer; or

• Amelioration of volume depletion from enterocutaneous fistulae; or• Prevention and treatment of pancreatic fistulas following pancreatic surgery; or• Bleeding gastroesophageal (GE) varices when BOTH of the following are met:

o GE varices are associated with liver disease; ando Octreotide acetate is used in combination with endoscopic therapy (that

is, band ligation or sclerotherapy) or alone if endoscopic therapy is notimmediately available; or

• Chemotherapy or radiation-induced diarrhea that is unresponsive toconventional antidiarrheal medications (e.g., diphenoxylate and atropine orloperamide).

Lanreotide (Somatuline Depot) may be considered medically necessary for ANY thefollowing indications:

• Neuroendocrine Tumors - Adrenal Gland Tumors for:


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o Symptom control if somatostatin receptor scintigraphy is positive in patientswith non-adrenocorticotropic hormone (ACTH)-dependent Cushing'ssyndrome with tumors less than 4 cm, benign imaging characteristics, andabnormal contralateral gland and symmetric cortisol production; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, andThymus as:

o Primary treatment for unresected primary gastrinoma; oro Management of locoregional unresectable disease and/or distant

metastases as a single agent or in combination with other systemictherapies; if disease progression, treatment with lanreotide may becontinued in combination with any of the subsequent treatment options;or

o Treatment of carcinoid syndrome: As a single agent; or In combination with telotristat for persistent diarrhea due to

poorly controlled carcinoid syndrome; or In combination with subsequent treatment options for persistent

symptoms such as flushing or diarrhea; or• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas for:

o Treatment of symptoms related to hormone hypersecretion; if diseaseprogression, treatment with lanreotide may be continued in combinationwith any of the subsequent treatment options; or

o For tumor control in patients with unresectable locoregional diseaseand/or metastatic disease and clinically significant tumor burden orclinically significant progression if not already given; or

• Treatment of patients with unresectable, well-or moderately-differentiated,locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors(GEP-NETs) to improve progression-free survival; or

• For the long-term treatment of acromegaly in patients who have had aninadequate response to surgery and/or radiotherapy, or for whom surgeryand/or radiotherapy is not an option.

This new criteria will apply to both professional provider and facility claims. Theeffective date is November 27, 2017.


Please refer to Medical Policy I-175, Octreotide acetate (Sandostatin, SandostatinLAR) and Lanreotide (Somatuline Depot) for additional information.


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Revised Coverage Criteria for Wireless Capsule Endoscopy as aDiagnostic Technique in Disorders of the Small Bowel, Esophagus, andColon

Highmark Blue Shield has revised coverage criteria for Wireless Capsule Endoscopyas a Diagnostic Technique in Disorders of the Small Bowel, Esophagus, and Colon.These criteria will apply to both professional provider and facility claims. The effectivedate is November 27, 2017.


Wireless capsule endoscopy (WCE) of the small intestine may be consideredmedically necessary for ages 2 years and older for the following indications whenconventional endoscopic and diagnostic imaging evaluations (e.g., uppergastrointestinal endoscopy, colonoscopy, push enteroscopy, nuclear imaging, orradiological procedure) are inconclusive:

• To investigate anemia with concomitant iron deficiency, suspected to be of

small bowel origin, after appropriate evaluation (at a minimum lower and upper

endoscopy) has excluded a source of anemia from the upper GI tract and

colon.

WCE is considered experimental and investigational for all other indications includingbut not limited to the following because of insufficient evidence of efficacy and safety;therefore considered non-covered:

• Use of a patency capsule.

Please refer to Medical Policy G-41, Wireless Capsule Endoscopy as a DiagnosticTechnique in Disorders of the Small Bowel, Esophagus, and Colon for additionalinformation.

Change in Policy Position for In Vitro Chemoresistance andChemosensitivity Assays

Highmark Blue Shield has changed its policy position for in vitro chemoresistanceand chemosensitivity testing. These assays will be consideredexperimental/investigational. There is insufficient evidence that chemosensitivity orchemoresistance testing affects clinical decision-making and that health outcomesare improved as a result of the testing.

This policy will apply to both professional provider and facility claims. The effectivedate is November 27, 2017.


Please refer to Medical Policy L-58, In Vitro Chemoresistance and ChemosensitivityAssays, for additional information.


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Revised Criteria for Electromyography (EMG)

Effective November 27, 2017, clinical criteria for Electromyography (EMG) have beenrevised. Additionally, Highmark (HMK) Medical Policy M-51, Nerve ConductionStudies is combined with HMK Medical Policy M-28, Electromyography (EMG). Thepolicy title will reflect this change by being revised to: Nerve Conduction Studies andElectromyography (EMG) and applies both to Professional and Facility Claims.

The following clinical indication has been added under the EMG policy criteria:

• Recurrent laryngeal neuropathy (RLN), (unilateral or bilateral vocal cord fold

paralysis) that is greater than 4 weeks, but less than 6 months in duration.

Additionally, criteria have been added to reflect electrodiagnostic assessment thatconsists of EMG and NVC may be considered medically necessary as an adjunct tohistory, physical exam and imaging studies.

A repeat electrodiagnostic assessment may be considered medically necessary whenat least ONE of the following criteria have been met:

• Development of new symptoms or signs suggesting a second diagnosis in a

patient who has received an initial diagnosis; or

• Interim progression of disease following an initial test that was inconclusive,

such that a repeat test is likely to elicit additional findings; or

• Unexpected change(s) in the course of disease or response to treatment,

suggesting that the initial diagnosis may be incorrect and that reexamination is

indicated.

The following tests are considered experimental/investigational:

• Automated non-Invasive electro-diagnostic testing with a computerized hand-

held device (e.g., NC-stat®) to stimulate and measure neuromuscular signals;

and

• Quantitative sensory testing (QST) which is the assessment of perceptual

and/or physiological responses to pain.


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Criteria Updated for Upper Gastrointestinal Endoscopy/Esophagoscopy

Highmark Blue Shield has revised the clinical criteria for Upper GastrointestinalEndoscopy/Esophagoscopy. The revisions will apply to both professional provider andfacility claims. The effective date is November 27, 2017.

High Risk Screening Esophagogastroduodenoscopy (EGD)

EGD/upper endoscopy may be considered medically necessary for high risk screeningin the following conditions:

• Individuals with a family history of esophageal or gastric cancer; or

• Individuals with familial adenomatous polyposis (FAP) syndrome; or

• Individuals being considered for bariatric surgery in which the presence of upper

gastrointestinal (GI) pathological conditions might modify planned management.

Diagnostic EGD

Diagnostic EGD may be considered medically necessary for the following criteria:

• Individuals with a positive tissue transglutaminase (TTG); or

• Individuals with symptomatic pernicious anemia (e.g., anemia, fatigue, pallor, red

tongue, shortness of breath, as well as tingling and numbness in the hands and

feet) to identify prevalent lesions (e.g., carcinoid tumors, gastric cancer).

Therapeutic EGD

Therapeutic EGD may be considered medically necessary for the following criteria:

• Endoscopic mucosal resection for suspicious lesions of the upper layer.

Sequential or Periodic EGD

Sequential or periodic EGD may be considered medically necessary in the followingconditions:

• To assess for healing or Barrett’s in patients with severe erosive esophagitis or

ulcer after a two (2) month course of PPI therapy; or

• Follow-up of individuals with dysplastic Barrett’s esophagus (BE) after ablative

therapy every three (3) to six (6) months for one (1) year; or

• Follow-up of esophageal, gastric or stomal ulcers to demonstrate healing in

patients with continued symptoms despite adequate medical therapy trial in two

(2) to four (4) months; or

• Follow-up in individuals with prior adenomatous gastric polyps in one (1) year

after resection six (6) months after resection of sessile and dysplastic polyps and

in high risk patients every one (1) to three (3) years; or

• Follow-up of individuals after treatment of esophageal varices every one (1) to

three (3) months till varices adequately treated; or

• Follow-up of individuals after endoscopic mucosal resection every three (3) to six


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(6) months until completion of resection; or

• Follow-up of gastric intestinal metaplasia every one (1) to three (3) years.

Endoscopic retrograde cholangiopancreatography (ERCP)

ERCP may be considered medically necessary for the following biliary and pancreaticconditions:

• Traumatic pancreatitis to accurately localize the injury and provide endoscopic

drainage; or

• Pancreatic duct stricture evaluation; or

• The extraction of bile duct stones in severe gallstone induced pancreatitis; or

• Detecting pancreatic ductal changes in chronic pancreatitis and also the

presence of calcified stones in the ductal system. A pancreatogram may be

performed and is likely to be abnormal in chronic alcoholic pancreatitis but less

so in non-alcoholic induced types; or

• Individuals with radiologic imaging suggestive of common bile duct stones or

other potential pathology.

ERCP is considered not medically necessary for the following:

• The diagnosis of pancreatitis except for suspected gallstone pancreatitis; and

• Early stages of, or in acute pancreatitis and could possibly exacerbate it.

Endoscopic ultrasound (EUS)

EUS may be considered medically necessary for ANY of the following indications:

• Diagnosis of common bile duct stones; or

• Evaluate abnormalities of the biliary tree; or

• Evaluate abnormalities of the gastrointestinal tract wall or adjacent structures; or

• Evaluate abnormalities of the pancreas, including masses, pseudocysts and

chronic pancreatitis; or

• Evaluate adenopathy and masses of the posterior mediastinum (endoscopic

ultrasonography with fine-needle aspiration); or

• Gallbladder drainage for acute cholecystitis; or

• Pre-operative staging of gastric cancer; or

• Providing endoscopic therapy of the gastrointestinal tract under ultrasonographic

guidance; or

• Tissue sampling of lesions within, or adjacent to, the wall of the gastrointestinal

tract; or

• Staging of lung cancer (endoscopic ultrasonography with fine-needle aspiration);

or

• Staging tumors of the gastrointestinal tract, pancreas and bile ducts; or

• Follow-up of certain gastric subepithelial masses (asymptomatic glomus tumors

or small (less than 3 cm) gastrointestinal stromal tumors).



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Please refer to Medical Policy M-77, Upper Gastrointestinal Endoscopy/Esophagoscopyfor additional information.

New Policy Established for Noninvasive Techniques for the Evaluation andMonitoring of Patients with Chronic Liver Disease

Highmark Blue Shield has established new coverage criteria for noninvasive techniquesfor the evaluation and monitoring of patients with chronic liver disease. The new criteriawill apply to both professional provider and facility claims. The effective date is November27, 2017.

Place of Service: Inpatient/Outpatient

Please refer to Medical Policy M-79, Noninvasive Techniques for the Evaluation andMonitoring of Patients With Chronic Liver Disease for additional information.

Coverage Criteria Updated for Bio-Engineered Skin and Soft TissueSubstitutes

Highmark Blue Shield has revised the clinical criteria for Bio-Engineered Skin and SoftTissue Substitutes. This new criteria will apply to both professional and facility claims.The effective date was September 18, 2017.

AlloMend® added for use in breast reconstructive surgery.

AlloPatch® added for the treatment of chronic, noninfected, full-thickness diabetic lowerextremity ulcers.


Please refer to Medical Policy S-33, Bio-Engineered Skin and Soft Tissue Substitutes forcoverage criteria and additional information.

New Policy Established for Total Hip and Total Knee Arthroplasty

Highmark Blue Shield has established new coverage criteria for total hip and total kneearthroplasty. The new criteria will apply to professional provider claims. The effectivedate is November 27, 2017.

Place of Service: Inpatient

Please refer to Medical Policy S-247, Total Hip and Total Knee Arthroplasty for additionalinformation.


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Revised Criteria for Eculizumab

In the June 2017 Medical Policy Update, Highmark announced that beginningAugust 28, 2017, criteria was revised for Eculizumab. Highmark has postponed thepublication of Medical Policy I-130 Eculizumab until November 27, 2017.

Highmark Blue Shield considers the following criteria medically necessary for theadministration of Eculizumab:


The following criteria have been added to the policy:

• Change in the perimeter for Flow Cytometry results have been changed fromgreater than or equal to 10% of glycosylphosphatidylinositol-anchoredproteins (GPI-AP)-deficient polymorphonuclear cells (PMNs) to 50% ofglycosylphosphatidylinositol-anchored proteins (GPI-AP)-deficientpolymorphonuclear cells (PMNs).

• Qualifications for specific major adverse vascular events (MAVE) are nowlisted.

• Member clinical criteria for Hemoglobin that is less than or equal to 7 g/dL, orthe individual has symptoms of anemia and the hemoglobin is less than equalto 9 g/dL; or evidence of clinically elevated hemolysis lactate dehydrogenase(LDH) greater than or equal to 1.5 times the upper limit of normal (ULN) hasbeen added to the policy.

Please refer to Medical Policy I-130, Eculizumab for additional information.


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Coverage Criteria Revised for Carfilzomib (Kyprolis)

Highmark’s Medicare Advantage products have revised coverage criteria carfilzomib(Kyprolis®) based on the FDA approved indications and National Comprehensive CancerNetwork (NCCN) recommendations.



Please refer to Medical Policy I-57, Carfilzomib (Kyprolis®) for additional information.

Coverage Criteria Revised for Pemetrexed (Alimta)

Highmark’s Medicare Advantage products have revised coverage criteria pemetrexed(Alimta®) based on the FDA approved indications and National Comprehensive CancerNetwork (NCCN) recommendations.



Please refer to Medical Policy I-74, Pemetrexed (Alimta®) for additional information.

Coverage Criteria Revised for Radium Ra 223 Dichloride for Treatment ofProstate Cancer

Highmark’s Medicare Advantage products have established coverage criteria for Radium Ra223 Dichloride for treatment of prostate cancer.

Radium Ra 223 Dichloride for Treatment of Prostate Cancer (Xofigo®) may be consideredmedically necessary when ALL of the following criteria are met:

• The individual has been diagnosed with metastatic castration-resistant prostate

cancer (CRPC); and

• The individual has symptomatic skeletal (bone) metastases; and

• The individual has no known past or current lymph nodes or visceral metastatic

disease on imaging within the past thirty (30) days; and

• The individual has received and exhausted all medical or surgical-ablative hormonal

treatments. The individual may be kept on his ablative hormonal treatment to

maintain a castrate level in accordance with National Comprehensive Cancer

Network (NCCN) guidelines; and

• Prior to the initial dose, the individual must have an absolute neutrophil count greater

Medicare Advantage Policy


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than or equal to 1.5X109/L, platelet count greater than or equal to 100X109/L, and a

hemoglobin greater than or equal to 10g/dL; and

• Prior to the subsequent doses, patients must have absolute neutrophil count greater

than or equal to 1X109/L and platelet count greater than or equal to 50X109/L; and

• Radium RA 223 dichloride should be discontinued if a delay of 6-8 weeks does not

result in return of blood counts to these levels; and

• Medically or surgically-castration resistant prostate cancer, as defined by:

o A serum testosterone level of less than less than or equal to 50 ng/dL and

EITHER:

Sequential rise of prostate specific antigen (PSA) levels (two

consecutive increases over the previous reference value ); or

Worsening of existing bone metastases or development of new bone

metastases on a bone scan performed within the past 60 days despite

androgen-deprivation treatment.

Radium Ra 223 Dichloride for Treatment of Prostate Cancer (Xofigo) is considered notmedically necessary for any other indications not stated above.

Concurrent chemotherapy with Xofigo is considered experimental/investigational andtherefore non-covered. Scientific evidence does not support its use with concurrentchemotherapy.



Please refer to Medical Policy I-97, Radium Ra 223 Dichloride for Treatment of ProstateCancer for additional information.

Coverage Criteria and Policy Title Revised for PD-1 and PD-L1 BlockingAntibodies

Highmark’s Medicare Advantage products have established additional criteria for oncologicindications for PD-1 blocking antibodies. The revised criteria will apply to both professionalprovider and facility claims. The effective date is November 27, 2017.


The following Oncologic PD-1 Blocking Antibodies have been added:

• Avelumab (Bavencio)

• Durvalumab (Imfinzi)

New indications have been added for the following:

• Pembrolizumab (Keytruda)

• Nivolumab (Opdivo)

• Atezolizumab (Tecentriq)


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Please refer to Medical Policy I-120, Oncologic Indications for PD-1 Blocking Antibodies foradditional information.

Coverage Criteria Established for Octreotide acetate (Sandostatin,Sandostatin LAR) and Lanreotide (Somatuline Depot)

Highmark’s Medicare Advantage products have established coverage criteria for octreotideacetate (Sandostatin, Sandostatin LAR) and Lanreotide (Somatuline Depot).

Octreotide acetate (Sandostatin) may be considered medically necessary for ANY of thefollowing indications:

• Acromegaly for patients who have had an inadequate response to or cannot betreated with:




• Central Nervous System Cancers - Meningiomas when used as:o Treatment for surgically inaccessible recurrent or progressive meningiomas

when further radiation is not possible; or• Neuroendocrine Tumors - Adrenal Gland Tumors:

o For symptom control if somatostatin receptor scintigraphy is positive inpatients with non-adrenocorticotropic hormone (ACTH)-dependent Cushing'ssyndrome with tumors less than 4 cm, benign imaging characteristics, andabnormal contralateral gland and symmetric cortisol production; or


o Primary treatment for unresected primary gastrinoma: oro Management of locoregional unresectable disease and/or distant metastases

as a single agent or in combination with other systemic therapies; if diseaseprogression, treatment with octreotide may be continued in combination withany of the subsequent treatment options; or

o Treatment of underlying Zollinger-Ellison syndrome; oro Prophylactic treatment prior to surgery for gastrinoma; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used as:o Treatment of symptoms related to hormone hypersecretion; if disease

progression, treatment with octreotide may be continued in combination withany of the subsequent treatment options; or



• Acquired immune deficiency syndrome (AIDS) - treatment of severe secretorydiarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin ormetronidazole) or anti-motility agents (e.g. loperamide or diphenoxylate and atropine)have become ineffective; or

• Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g., nausea,pain, vomiting) of inoperable bowel obstruction in persons with terminal cancer; or


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• Amelioration of volume depletion from enterocutaneous fistulae: or• Prevention and treatment of pancreatic fistulas following pancreatic surgery; or• Bleeding gastroesophageal (GE) varices when BOTH of the following are met:

o GE varices are associated with liver disease; ando Octreotide acetate is used in combination with endoscopic therapy (that is,

band ligation or sclerotherapy) or alone if endoscopic therapy is notimmediately available; or

• Chemotherapy or radiation-induced diarrhea that is unresponsive to conventionalantidiarrheal medications (e.g., diphenoxylate and atropine or loperamide).

Octreotide acetate (Sandostatin LAR) may be considered medically necessary for ANY thefollowing indications:

• Acromegaly for patients who have had an inadequate response to or cannot betreated with:




• Central Nervous System Cancers - Meningiomas when used as:o Treatment for surgically inaccessible recurrent or progressive meningiomas

when further radiation is not possible; or• Neuroendocrine Tumors - Adrenal Gland Tumors:

o For symptom control if somatostatin receptor scintigraphy is positive inpatients with non-adrenocorticotropic hormone (ACTH)-dependent Cushing'ssyndrome with tumors less than 4 cm, benign imaging characteristics, andabnormal contralateral gland and symmetric cortisol production; or


o Primary treatment for unresected primary gastrinoma: oro Management of locoregional unresectable disease and/or distant metastases

as a single agent or in combination with other systemic therapies; if diseaseprogression, treatment with octreotide may be continued in combination withany of the subsequent treatment options; or

o Treatment of underlying Zollinger-Ellison syndrome; oro Prophylactic treatment prior to surgery for gastrinoma; oro Treatment of carcinoid syndrome when used as:

As a single agent; or In combination with telotristat for persistent diarrhea due to poorly

controlled carcinoid syndrome; or In combination with subsequent treatment options for persistent

symptoms such as flushing or diarrhea; or• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas when used as:

o Treatment of symptoms related to hormone hypersecretion; if diseaseprogression, treatment with octreotide may be continued in combination withany of the subsequent treatment options; or

o For tumor control in patients with unresectable locoregional disease and/ormetastatic disease and clinically significant tumor burden or clinicallysignificant progression if not already given; or

• Thymomas and Thymic Carcinomas when used as second-line therapy with or


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without prednisone; or• Poorly Differentiated (High Grade)/Large or Small Cell for symptom control if

somatostatin scintigraphy positive; or• Acquired immune deficiency syndrome (AIDS) - treatment of severe secretory

diarrhea associated with AIDS when anti-microbial (e.g., ciprofloxacin ormetronidazole) or anti-motility agents (eg. loperamide or diphenoxylate and atropine)have become ineffective; or

• Bowel obstruction - management of gastrointestinal (GI) symptoms (e.g., nausea,pain, vomiting) of inoperable bowel obstruction in persons with terminal cancer; or

• Amelioration of volume depletion from enterocutaneous fistulae: or• Prevention and treatment of pancreatic fistulas following pancreatic surgery; or• Bleeding gastroesophageal (GE) varices when BOTH of the following are met:

o GE varices are associated with liver disease; ando Octreotide acetate is used in combination with endoscopic therapy (that is,

band ligation or sclerotherapy) or alone if endoscopic therapy is notimmediately available; or

• Chemotherapy or radiation-induced diarrhea that is unresponsive to conventionalantidiarrheal medications (e.g., diphenoxylate and atropine or loperamide).

Lanreotide (Somatuline Depot) may be considered medically necessary for ANY thefollowing indications:

• Neuroendocrine Tumors - Adrenal Gland Tumors for:o Symptom control if somatostatin receptor scintigraphy is positive in patients with

non-adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome withtumors less than 4 cm, benign imaging characteristics, and abnormalcontralateral gland and symmetric cortisol production; or

• Neuroendocrine Tumors - Neuroendocrine Tumors of the GI Tract, Lung, andThymus as:

o Primary treatment for unresected primary gastrinoma; oro Management of locoregional unresectable disease and/or distant metastases

as a single agent or in combination with other systemic therapies; if diseaseprogression, treatment with lanreotide may be continued in combination withany of the subsequent treatment options; or

o Treatment of carcinoid syndrome: As a single agent; or In combination with telotristat for persistent diarrhea due to poorly

controlled carcinoid syndrome; or In combination with subsequent treatment options for persistent

symptoms such as flushing or diarrhea; or• Neuroendocrine Tumors - Neuroendocrine Tumors of the Pancreas for:

o Treatment of symptoms related to hormone hypersecretion; if diseaseprogression, treatment with lanreotide may be continued in combination withany of the subsequent treatment options; or

o For tumor control in patients with unresectable locoregional disease and/ormetastatic disease and clinically significant tumor burden or clinicallysignificant progression if not already given; or

• Treatment of patients with unresectable, well-or moderately-differentiated, locallyadvanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs)to improve progression-free survival; or

• For the long-term treatment of acromegaly in patients who have had an inadequateresponse to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy isnot an option.


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Please refer to Medical Policy I-175, Octreotide acetate (Sandostatin, Sandostatin LAR) andLanreotide (Somatuline Depot) for additional information.

Coverage Criteria Revised for Alpha 1 Proteinase Inhibitor Infusions

Highmark’s Medicare Advantage products have revised clinical criteria for Alpha 1Proteinase Inhibitor infusions. Based on the FDA approved indications, this new criteria willapply to both professional provider and facility claims.

The effective date is November 27, 2017.


The following criteria has been changed in the policy:

• There is a documented high risk phenotype** resulting in a low serum concentration

of Alpha 1 antitrypsin (AAT), as evidenced by less than 80 mg per deciliter (mg/dL)

(0.8 g/L) by radial immundiffusion (or less than 50 mg/dL (0.5 g/L) if measured by

nephelometry) or less than 11 uM/L (35 % of normal).

** PiZZ, PiZ, or Pi phenotype (homozygous) or other phenotypes, (PiSZ or PiMS)

associated with serum AAT concentrations of less than 80 mg/dL.

Please refer to Medical Policy I-126, Alpha 1 Proteinase Inhibitor Infusions for additionalinformation.

Coverage Criteria Revised for Decitabine (Dacogen)

Highmark’s Medicare Advantage products have revised clinical criteria for Decitabine(Dacogen®) based on the FDA approved indications and the National ComprehensiveCancer Network (NCCN). This new criteria will apply to both professional provider andfacility claims.

The following criteria were added to Medical Policy I-128:

• Treatment of lower risk disease associated with symptomatic anemia and serumerythropoietin levels less than or equal to 500 mU/mL with no response toerythropoietins alone and in combination with lenalidomide and no response orintolerance to immunosuppressive therapy.

• Used as a single agent for patients age greater than or equal to 60 years as:o Lower intensity induction therapy:

For intensive remission induction therapy in patients with unfavorablecytogenetic or molecular markers/antecedent hematologicdisorder/therapy-related AML; or

When the patient is not a candidate for intensive remission induction


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therapy; or Declines intensive therapy; or

• Post-remission therapy: Following a response to prior lower intensive therapy; or Maintenance therapy following complete response to prior intensive

therapy if the patient received hypomethylating agents (e.g.azacitidine, decitabine) during induction; or

• In therapy for relapse or refractory disease in patients who cannot toleratemore aggressive regimens: As a single agent; or In combination with sorafenib (FLT3-ITD mutation positive).

Myeloproliferative Neoplasms - Primary Myelofibrosis and Post PV Myelofibrosis or Post ETMF:

• For treatment of myelofibrosis (MF) accelerated phase; or• MF blast phase acute myeloid leukemia.



Please refer to Medical Policy I-128, Decitabine (Dacogen®) for additional information.

Revised Criteria for Eculizumab

Highmark’s Medicare Advantage products have revised clinical criteria for Eculizumab.Based on the FDA approved indications, this new criteria will apply to both professionalprovider and facility claims.



The following criteria have been added to the policy:

• Change in the perimeter for Flow Cytometry results have been changed fromgreater than or equal to 10% of glycosylphosphatidylinositol-anchored proteins(GPI-AP)-deficient polymorphonuclear cells (PMNs) to 50% ofglycosylphosphatidylinositol-anchored proteins (GPI-AP)-deficientpolymorphonuclear cells (PMNs).

• Qualifications for specific major adverse vascular events (MAVE) are now listed.• Member clinical criteria for Hemoglobin that is less than or equal to 7 g/dL, or the

individual has symptoms of anemia and the hemoglobin is less than equal to 9g/dL; or evidence of clinically elevated hemolysis lactate dehydrogenase (LDH)greater than or equal to 1.5 times the upper limit of normal (ULN) has beenadded to the policy.

Please refer to Medical Policy I-130, Eculizumab for additional information.


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Comments on these new medical policies?We want to know what you think about our new medical policy changes. Send us an email with any questions

or comments that you may have on the new medical policies in this edition of Medical Policy Update.

Write to us at [email protected].

Coverage Criteria Revised for Certolizumab (Cimzia) ...................................................................................................... 1

Courtesy Update for Tocilizumab (Actemra)...................................................................................................................... 2

Criteria Updated for Golimumab (Simponi, Simponi Aria) ............................................................................................... 2

Coverage Criteria Revised for Ustekinumab (Stelara) ...................................................................................................... 3

Coverage Criteria Revised for Carfilzomib (Kyprolis) ....................................................................................................... 3

Coverage Criteria Revised for Pemetrexed (Alimta) ......................................................................................................... 4

Coverage Criteria Revised for Abatacept (Orencia) IV and SC ........................................................................................ 4

Coverage Criteria Revised for Radium Ra 223 Dichloride for Treatment of Prostate Cancer ...................................... 5

Coverage Criteria and Policy Title Revised for PD-1 and PD-L1 Blocking Antibodies.................................................. 6

Coverage Criteria Established for Octreotide acetate (Sandostatin, Sandostatin LAR) and Lanreotide (SomatulineDepot) ..................................................................................................................................................................................... 6

Revised Coverage Criteria for Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the SmallBowel, Esophagus, and Colon........................................................................................................................................... 10

Change in Policy Position for In Vitro Chemoresistance and Chemosensitivity Assays ........................................... 10

Revised Criteria for Electromyography (EMG)................................................................................................................. 11

Criteria Updated for Upper Gastrointestinal Endoscopy/Esophagoscopy................................................................... 12

New Policy Established for Noninvasive Techniques for the Evaluation and Monitoring of Patients with ChronicLiver Disease ...................................................................................................................................................................... 14

Coverage Criteria Updated for Bio-Engineered Skin and Soft Tissue Substitutes...................................................... 14

New Policy Established for Total Hip and Total Knee Arthroplasty .............................................................................. 14

Revised Criteria for Eculizumab........................................................................................................................................ 15

Coverage Criteria Revised for Carfilzomib (Kyprolis) ..................................................................................................... 16

Coverage Criteria Revised for Pemetrexed (Alimta) ....................................................................................................... 16

Coverage Criteria Revised for Radium Ra 223 Dichloride for Treatment of Prostate Cancer .................................... 16

Coverage Criteria and Policy Title Revised for PD-1 and PD-L1 Blocking Antibodies................................................ 17

Coverage Criteria Established for Octreotide acetate (Sandostatin, Sandostatin LAR) and Lanreotide (SomatulineDepot) ................................................................................................................................................................................... 18

Coverage Criteria Revised for Alpha 1 Proteinase Inhibitor Infusions ......................................................................... 21

Coverage Criteria Revised for Decitabine (Dacogen) ..................................................................................................... 21

Revised Criteria for Eculizumab........................................................................................................................................ 22

Comments on these new medical policies?..................................................................................................................... 23

Contents............................................................................................................................................................................... 23

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Medical Policy Update is the monthly newsletter for most health care professionals (and office staff) and facilities who participate in our networks and

submit claims to Highmark using the 837P HIPAA transaction or the CMS 1500 form, or the 837I HIPAA transaction.

Medical Policy Update focuses only on medical policy and claims administration updates, including coding guidelines and procedure code revisions, andis the sole source for this information. For all other news, information and updates, be sure to read Provider News, available on the Provider Resource

Center at www.highmarkblueshield.com.

Inquiries about Eligibility, Benefits, Claims Status or Authorizations

For inquiries about eligibility, benefits, claim status or authorizations, Highmark Blue Shield encourages providers to use the electronic resources

available to them - NaviNet® and the applicable HIPAA transactions – prior to placing a telephone call to the Provider Service Center at 1-866-803-3708.

Acknowledgement

The five-digit numeric codes that appear in Medical Policy Update were obtained from the Current Procedural Terminology (CPT), as contained in CPT-

2017, Copyright 2016, by the American Medical Association. Medical Policy Update includes CPT descriptive terms and numeric procedure codes and

modifiers that are copyrighted by the American Medical Association. These procedure codes and modifiers are used for reporting medical services and

procedures.

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