ModifiedBlue Cross Blue Shield - MassachusettsPolicy 125

Medical benefit prior authorization for selected specialty drugs and injectables

Defines prior authorization requirements, applicable HCPCS codes, preferred devices/supplies, and medical-necessity criteria for specialty pharmacy and medical-benefit administered drugs for Blue Cross Blue Shield of Massachusetts members (including Medicare Advantage). Affects prescribing providers and facilities requesting coverage for listed drugs and devices.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyMedical benefit prior authorization for selected specialty drugs and injectables

Policy CodePolicy 125

Change TypeMultiple drug additions and preferred device updates

Effective Date

Next Review Date

Key ActionRequest preservice authorization via phone, fax, mail (authorization form) or eForm to Blue Cross Blue Shield of Massachusetts Pharmacy Operations for medical-benefit outpatient administrations.

SourceLink

POLICY UPDATE CHANGES

Multiple drugs (Givlaari, Amvuttra, Onpattro, Elfabrio, Fabrazyme, Altuviiio, Eloctate, Nuwiq, Alprolix, Cerezyme, Cimzia, Ilumya, Tremfya, Nexviazyme, Oxlumo, treprostinil, Ezofri, Rykindo, Uzedy, Brixadi, Evenity, and Izervay) were added to the policy.

Tyruko was added to the policy.

Preferred diabetic glucose monitor products were changed: OneTouch products removed and Accu-Chek products added as preferred.

Policy was updated to include Kisunla per CMS NCD, effective 8/1/2024.

~100+HCPCS codes listed

1Evenity year limit

Age >=18

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Coverage Criteria

Evenity (romosozumab-aqqg)

Covered when ALL of the following are met

Evenity criteria: 1. Diagnosis of osteoporosis; AND 2. Considered high risk for fracture defined as a history of osteoporotic fracture or multiple risk factors for fracture OR patients who have failed or are intolerant to other available osteoporosis therapy; AND 3. Treatment duration limited to 12 monthly doses12 monthly doses

Izervay (avacincaptad pegol)

Covered when ALL of the following are met

Izervay criteria: 1. Age 18 years and older; AND 2. Confirmed diagnosis of Geographic Atrophy (GA); AND 3. Absence of Choroidal Neovascularization (CNV) in both eyes; AND 4. Secondary to Age-Related Macular Degeneration (AMD)

Diabetic Glucose Monitors and Supplies

Preferred devices/supplies will be covered without preservice authorization; non-preferred may be covered when ALL following are met

Non-preferred diabetic supplies: 1. The drug/device must be used for a medically accepted indication supported by FDA labeling or Medicare-approved references; AND 2. There must be evidence of a BCBSMA claim or prescriber-documented use of two preferred devices/supplies

Preferred devices listed (Accu-Chek, Freestyle, Dexcom, Freestyle Libre) are covered without preservice authorization

Preservice prior authorization requirements have been updated for medications administered under the member's medical benefit in outpatient settings. Preservice authorization is required when medications are administered in a clinician's or physician's office, by a home health care provider, by a home infusion therapy provider, in outpatient hospital and dialysis settings, or in surgical day care. This change does not affect inpatient, urgent care center, or emergency department settings.

Preferred diabetic devices and supplies listed in the policy are covered without preservice authorization. Coverage of non-preferred devices/supplies (those not listed as preferred) may be approved only when ALL of the following are met: the drug or device is used for a medically accepted indication supported by the FDA labeling and/or Medicare-approved medical references, and there is documentation of either a BCBSMA claim or prescriber-documented use of two preferred devices/supplies.

Coding and HCPCS/NDC

Applicable HCPCS Codes (part 1)HCPCS

J0585	Injection, onabotulinumtoxinA, 1 unit
J0586	Injection, abobotulinumtoxinA, 5 Units
J0587	Injection, rimabotulinumtoxinB, 100 units
J0588	Injection, incobotulinumtoxinA, 1 unit
J2357	Injection, omalizumab, 5 mg
J2182	Injection, mepolizumab, 1 mg
J0517	Injection, benralizumab, 1 mg
J2786	Injection, reslizumab, 1 mg
J2350	Injection, ocrelizumab, 1 mg
J3380	Injection, vedolizumab, 1 mg

1–10 of 17

1/2

Applicable HCPCS Codes (part 2)HCPCS

J1459	Injection, immune globulin (privigen), intravenous, non-lyophilized (e.g., liquid), 500 mg
J1460	Injection, gamma globulin, intramuscular, 1 cc
J1554	Injection, immune globulin (asceniv), 500 mg
J1555	Injection, immune globulin (cuvitru), 100 mg
J1556	Injection, immune globulin (bivigam), 500 mg
J1557	Injection, immune globulin, (gammaplex), intravenous, non-lyophilized (e.g., liquid), 500 mg
J1558	Injection, immune globulin (xembify), 100 mg
J1559	Injection, immune globulin (hizentra), 100 mg
J1560	Injection, gamma globulin, intramuscular, over 10 cc
J1561	Injection, immune globulin, (gamunex-c/gammaked), non-lyophilized (e.g., liquid), 500 mg

1–10 of 17

1/2

Applicable HCPCS Codes (part 3)HCPCS

J1566	Injection, immune globulin, intravenous, lyophilized (e.g., powder), not otherwise specified, 500 mg
J2791	Injection, rho(d) immune globulin (human), (rhophylac), intramuscular or intravenous, 100 iu
J0174	Injection, lecanemab-irmb (Leqembi), intravenous
J0175	Injection, donanemab-azbt, 2 mg
J2323	Injection, natalizumab, 1 mg
Q5134	Injection, natalizumab-sztn (tyruko), biosimilar, 1 mg
J2329	Injection of ublituximab-xiiy, 1 mg
J0223	Injection, givosiran, 0.5 mg
J0225	Injection, vutrisiran, 1 mg
J0222	Injection, Patisiran, 0.1 mg

1–10 of 17

1/2

Applicable HCPCS Codes (part 4)HCPCS

J0717	Injection, certolizumab pegol, 1 mg (Medicare administrative note)
J3245	Injection, tildrakizumab, 1 mg
J1628	Injection, guselkumab, 1 mg
J0219	Injection, avalglucosidase alfa-ngpt, 4 mg
J0224	Injection, lumasiran, 0.5 mg
J2428	Injection, risperidone (rykindo), 0.5 mg
J2801	Injection, risperidone (rykindo), 0.5 mg
J2799	Injection, risperidone (uzedy), 1 mg
J0577	Injection, buprenorphine extended-release (brixadi), less than or equal to 7 days of therapy
J0578	Injection, buprenorphine extended release (brixadi), greater than 7 days and up to 28 days of therapy

1–10 of 12

1/2

Blood glucose test strips — non‑insulin users

Limit (non-insulin users)100 blood glucose test strips per 90 days

Applicable devicesPreferred blood glucose test strips: Accu-Chek Aviva Plus; Accu-Chek Guide; Accu-Chek Smart; Freestyle; Freestyle Insulinx; Freestyle Lite; Freestyle Precision Neo; Precision Xtra

ScopeApplies to preferred blood glucose test strips for non-insulin users as listed in Diabetic Glucose Monitors and Supplies

Blood glucose test strips — insulin users

Limit (insulin users)400 blood glucose test strips per 90 days

Applicable devices

Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior Authorization Required for Medical-Benefit Outpatient Administration. When medications listed in this policy are administered under the member's medical benefit in outpatient settings, preservice prior authorization is required. Providers must request authorization before administration to avoid claim denials or delays.

Preservice authorization required in these settings: clinician/physician office; home health care; home infusion therapy; outpatient hospital and dialysis settings; surgical day care.
This requirement does not apply to inpatient, urgent care, or emergency department settings.
To request prior authorization: call Pharmacy Operations at 1-800-366-7778, fax to 1-866-463-7700 (or 1-800-583-6289 where noted), mail the completed Authorization form to Blue Cross Blue Shield of Massachusetts, Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043, or submit the Massachusetts Standard preservice eForm.

Note

How to Request Prior Authorization

How to request prior authorization and contact info. Providers may call, fax, mail the Authorization form, or submit an eForm. Prescribers may also send relevant clinical information to the Pharmacy Operations Department at the address/phone/fax below.

Initial Therapy Criteria

Evenity initial therapy

Evenity initial: Diagnosis of osteoporosis; high risk for fracture OR failed/intolerant to other therapy; duration limited to 12 monthly doses12 monthly doses

Izervay initial therapy

Izervay initial: Age >=18; confirmed Geographic Atrophy; absence of CNV in both eyes; secondary to AMD

Step Therapy

Step	Requirement	Documentation required	Coverage status
1	Evidence of prior use of two preferred devices/supplies is required before non-preferred devices/supplies may be covered	BCBSMA claim history or prescriber-documented use demonstrating use of two Preferred devices/supplies	Covered with criteria

Quantity Limits

Blood glucose test strips — quantity limits

Non-insulin users100 strips per 90 days

Insulin users400 strips per 90 days

ReferenceLimits specified under Diabetic Glucose Monitors and Supplies (preferred devices/supplies)

Preferred diabetic monitors/supplies — quantity limit

Preferred monitors/supplies limit1 box per year

Included itemsPreferred blood glucose monitors and select continuous glucose monitor items as listed (Accu-Chek, Freestyle, Dexcom, Freestyle Libre)

Applies to

Site of Care Requirements

Prior Authorization

Preservice authorization required for outpatient medical-benefit administration

Preservice prior authorization is required when medications are administered under the medical benefit in physician office, home health/home infusion, infusion center, hospital outpatient, dialysis, and surgical day care settings; obtain authorization prior to service to avoid potential denials.

Biosimilar Information

Billing Rule

J2323 and Tyruko (natalizumab-sztn) listed — coverage inclusion

The HCPCS listing includes J2323 for natalizumab and the biosimilar Q5134 (Tyruko) is listed alongside it, indicating coverage inclusion for Tyruko (natalizumab-sztn) under the policy’s applicable codes.

J2323 — Injection, natalizumab, 1 mg
Q5134 — Injection, natalizumab-sztn (Tyruko), biosimilar, 1 mg

Background

This policy follows CMS National Coverage Determinations (NCD) and Local Coverage Determinations (LCD) guidance for Medicare Advantage members when such guidance is available. Where NCD/LCD guidance is not applicable, the policy relies on FDA labeling and Medicare-accepted medical references to define medical necessity and coverage criteria for listed drugs and devices. Preservice authorization requirements described in this policy apply to the outpatient settings listed above and do not change inpatient, urgent care, or emergency department coverage processes.

Definitions

NCD/LCD — CMS guidance

DefinitionCMS NCD/LCD/Article guidance

PurposeMedical necessity criteria and coding guidance for Medicare Advantage members are referenced to applicable NCDs and LCDs

Access noteTo review specific NCD/LCD/Article, accept the CMS licensing agreement on the CMS webpage