HIGHMARK COMMERCIAL MEDICAL POLICY - PENNSYLVANIA

 
 

Medical Policy:
I-42-029
Topic:
Zoledronic Acid (Reclast, Zometa)
Section:
Injections
Effective Date:
June 10, 2024
Issued Date:
June 10, 2024
Last Revision Date:
April 2024
Annual Review:
April 2024
 
 

Zoledronic acid (Reclast®, Zometa®) is a bisphosphonate that increases bone strength by inhibiting the rate of bone breakdown. Slowing the rate of bone break down allows the bone to recover and heal.  The therapeutic effects include reducing bone pain, decreasing high levels of calcium in the blood and decreasing the risk of hip and spine fractures.

Policy Position

Zoledronic acid (Zometa) may be considered medically necessary for individuals 18 years of age and older for ANY of the following:

  • Hypercalcemia of malignancy; or
  • For the treatment of individuals with multiple myeloma or with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy:
    • If using for individuals with prostate cancer, prostate cancer should have progressed after treatment with at least one hormonal therapy; or

Compendia Sources

Zoledronic acid (Zometa) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations; or

Other Medically Accepted Non-FDA Approved Recommendations, Class IIb or Higher Grade Recommendations

  • As adjuvant therapy for early stage breast cancer; or
  • For monoclonal gammopathy of uncertain significance with osteopenia or osteoporosis; or
  • As prophylactic therapy for osteopenia, secondary to hormone therapy in individuals with breast cancer; or
  • As prophylactic therapy for osteopenia, secondary to ovarian dysfunction induced by adjuvant chemotherapy in premenopausal women with early-stage breast cancer.

The use of zoledronic acid (Zometa) not meeting the criteria as indicated in this policy is considered not medically necessary.

J3489

 

 

 

 

 

 




Zoledronic acid (Reclast) may be considered medically necessary for ANY of the following:

  • For treatment of osteoporosis in postmenopausal women and men who have a documented trial and failure, or contraindication to oral bisphosphonate therapy:
    • Osteoporosis may be confirmed by the presence or history of osteoporotic fracture or by a finding of low bone mass (BMD more than 2.5 standard deviations below the normal adult reference population [i.e., T-score]).  Osteoporosis may also be diagnosed in individuals with osteopenia (BMD T-score between 1 – 2.5 standard deviations below normal adult reference population) AND Fracture Risk Assessment Tool (FRAX) indicates ten (10) year probability for major osteoporotic fracture of greater than or equal to 20% or the ten (10) year probability of hip fracture is greater than or equal to 3%; or
  • For the prevention of osteoporosis in postmenopausal women who have a documented trial and failure, or contraindication to oral bisphosphonate therapy; or
  • For the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and are expected to remain on glucocorticoids for at least 12 months:
    • Individual has documented trial and failure, or contraindication to oral bisphosphonate therapy; or
  • For the treatment of Paget’s disease in both men and women for ANY of the following:
    • With elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range; or
    • For those who are symptomatic; or
    • For those at risk for complications from their disease.

The use of zoledronic acid (Reclast) not meeting the criteria as indicated in this policy is considered not medically necessary.

Note: If the individual can tolerate oral bisphosphonates, then the injectable form is considered not medically necessary, and therefore, not covered.

J3489

 

 

 

 

 

 




Note: Failure of oral bisphosphonate therapy will be defined as a six (6) to twelve (12) month trial with ANY of the following:

  • A new fracture despite bisphosphonate therapy of six months or more; or
  • A T-score less than or equal to -2.5 despite bisphosphonate therapy of 12 months or more.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Highmark may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.


Related Policies

Refer to medical policy X-24 for guidelines on Bone Mineral Density Studies.

Refer to Medical Policy I-249 Pennsylvania Cancer Treatment Mandate, for additional information.


Covered Diagnosis Codes for J3489

C33

C34.00

C34.01

C34.02

C34.10

C34.11

C34.12

C34.2

C34.30

C34.31

C34.32

C34.80

C34.81

C34.82

C34.90

C34.91

C34.92

C40.00

C40.01

C40.02

C40.10

C40.11

C40.12

C40.20

C40.21

C40.22

C40.30

C40.31

C40.32

C40.80

C40.81

C40.82

C40.90

C40.91

C40.92

C41.0

C41.1

C41.2

C41.3

C41.4

C41.9

C50.011

C50.012

C50.019

C50.021

C50.022

C50.029

C50.111

C50.112

C50.119

C50.121

C50.122

C50.129

C50.211

C50.212

C50.219

C50.221

C50.222

C50.229

C50.311

C50.312

C50.319

C50.321

C50.322

C50.329

C50.411

C50.412

C50.419

C50.421

C50.422

C50.429

C50.511

C50.512

C50.519

C50.521

C50.522

C50.529

C50.611

C50.612

C50.619

C50.621

C50.622

C50.629

C50.811

C50.812

C50.819

C50.821

C50.822

C50.829

C50.911

C50.912

C50.919

C50.921

C50.922

C50.929

C61

C64.1

C64.2

C64.9

C65.1

C65.2

C65.9

C66.1

C66.2

C66.9

C68.0

C68.1

C68.8

C68.9

C73

C76.0

C78.00

C78.01

C78.02

C79.00

C79.01

C79.02

C79.51

C79.52

C79.81

C79.82

C90.00

C90.01

C90.02

C90.10

C90.11

C90.12

C90.20

C90.21

C90.22

C90.30

C90.31

C90.32

C94.30

C94.31

C94.32

C96.0

C96.20

C96.21

C96.22

C96.5

C96.6

D05.10

D05.11

D05.12

D05.80

D05.81

D05.82

D47.02

E83.52

M80.00XA

M80.00XD

M80.00XG

M80.00XK

M80.00XP

M80.00XS

M80.011A

M80.011D

M80.011G

M80.011K

M80.011P

M80.011S

M80.012A

M80.012D

M80.012G

M80.012K

M80.012P

M80.012S

M80.019A

M80.019D

M80.019G

M80.019K

M80.019P

M80.019S

M80.021A

M80.021D

M80.021G

M80.021K

M80.021P

M80.021S

M80.022A

M80.022D

M80.022G

M80.022K

M80.022P

M80.022S

M80.029A

M80.029D

M80.029G

M80.029K

M80.029P

M80.029S

M80.031A

M80.031D

M80.031G

M80.031K

M80.031P

M80.031S

M80.032A

M80.032D

M80.032G

M80.032K

M80.032P

M80.032S

M80.039A

M80.039D

M80.039G

M80.039K

M80.039P

M80.039S

M80.041A

M80.041D

M80.041G

M80.041K

M80.041P

M80.041S

M80.042A

M80.042D

M80.042G

M80.042K

M80.042P

M80.042S

M80.049A

M80.049D

M80.049G

M80.049K

M80.049P

M80.049S

M80.051A

M80.051D

M80.051G

M80.051K

M80.051P

M80.051S

M80.052A

M80.052D

M80.052G

M80.052K

M80.052P

M80.052S

M80.059A

M80.059D

M80.059G

M80.059K

M80.059P

M80.059S

M80.061A

M80.061D

M80.061G

M80.061K

M80.061P

M80.061S

M80.062A

M80.062D

M80.062G

M80.062K

M80.062P

M80.062S

M80.069A

M80.069D

M80.069G

M80.069K

M80.069P

M80.069S

M80.071A

M80.071D

M80.071G

M80.071K

M80.071P

M80.071S

M80.072A

M80.072D

M80.072G

M80.072K

M80.072P

M80.072S

M80.079A

M80.079D

M80.079G

M80.079K

M80.079P

M80.079S

M80.08XA

M80.08XD

M80.08XG

M80.08XK

M80.08XP

M80.08XS

M80.0AXA

M80.0AXD

M80.0AXG

M80.0AXK

M80.0AXP

M80.0AXS

M80.80XA

M80.80XD

M80.80XG

M80.80XK

M80.80XP

M80.80XS

M80.811A

M80.811D

M80.811G

M80.811K

M80.811P

M80.811S

M80.812A

M80.812D

M80.812G

M80.812K

M80.812P

M80.812S

M80.819A

M80.819D

M80.819G

M80.819K

M80.819P

M80.819S

M80.821A

M80.821D

M80.821G

M80.821K

M80.821P

M80.821S

M80.822A

M80.822D

M80.822G

M80.822K

M80.822P

M80.822S

M80.829A

M80.829D

M80.829G

M80.829K

M80.829P

M80.829S

M80.831A

M80.831D

M80.831G

M80.831K

M80.831P

M80.831S

M80.832A

M80.832D

M80.832G

M80.832K

M80.832P

M80.832S

M80.839A

M80.839D

M80.839G

M80.839K

M80.839P

M80.839S

M80.841A

M80.841D

M80.841G

M80.841K

M80.841P

M80.841S

M80.842A

M80.842D

M80.842G

M80.842K

M80.842P

M80.842S

M80.849A

M80.849D

M80.849G

M80.849K

M80.849P

M80.849S

M80.851A

M80.851D

M80.851G

M80.851K

M80.851P

M80.851S

M80.852A

M80.852D

M80.852G

M80.852K

M80.852P

M80.852S

M80.859A

M80.859D

M80.859G

M80.859K

M80.859P

M80.859S

M80.861A

M80.861D

M80.861G

M80.861K

M80.861P

M80.861S

M80.862A

M80.862D

M80.862G

M80.862K

M80.862P

M80.862S

M80.869A

M80.869D

M80.869G

M80.869K

M80.869P

M80.869S

M80.871A

M80.871D

M80.871G

M80.871K

M80.871P

M80.871S

M80.872A

M80.872D

M80.872G

M80.872K

M80.872P

M80.872S

M80.879A

M80.879D

M80.879G

M80.879K

M80.879P

M80.879S

M80.88XA

M80.88XD

M80.88XG

M80.88XK

M80.88XP

M80.88XS

M80.8AXA

M80.8AXD

M80.8AXG

M80.8AXK

M80.8AXP

M80.8AXS

M81.0

M81.6

M81.8

M84.451A

M84.452A

M84.459A

M84.551A

M84.552A

M84.553A

M84.559A

M84.651A

M84.652A

M84.653A

M84.659A

M85.9

M88.0

M88.1

M88.811

M88.812

M88.819

M88.821

M88.822

M88.829

M88.831

M88.832

M88.839

M88.841

M88.842

M88.849

M88.851

M88.852

M88.859

M88.861

M88.862

M88.869

M88.871

M88.872

M88.879

M88.88

M88.89

M88.9

M89.9

M94.9

T38.0X5A

T38.0X5D

T38.0X5S

T38.5X5A

T38.5X5D

T38.5X5S

T38.6X5A

T38.6X5D

T38.6X5S

T38.7X5A

T38.7X5D

T38.7X5S

Z78.0

Z79.51

Z79.52

 



Place of Service: Outpatient

Experimental/Investigational (E/I) services are not covered regardless of place of service.

The administration of Zoledronic Acid (Reclast, Zometa) is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.


The policy position applies to all commercial lines of business



Links






This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical or other circumstances may warrant individual consideration, based on review of applicable medical records, as well as other regulatory, contractual and/or legal requirements.

Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect Highmark's reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Highmark retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of Highmark. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
    • Qualified sign language interpreters
    • Written information in other formats (large print, audio, accessible electronic formats, other formats)
  • Provides free language services to people whose primary language is not English, such as:
    • Qualified interpreters
    • Information written in other languages

If you need these services, contact the Civil Rights Coordinator.

If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295, TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

U.S. Department of Health and Human Services
200 Independence Avenue, SW
Room 509F, HHH Building
Washington, D.C. 20201
1-800-368-1019, 800-537-7697 (TDD)

Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.

This information is issued by Highmark Blue Shield on behalf of its affiliated Blue companies, which are independent licensees of the Blue Cross Blue Shield Association.  Highmark Inc. d/b/a Highmark Blue Shield and certain of its affiliated Blue companies serve Blue Shield members in the 21 counties of central Pennsylvania. As a partner in joint operating agreements, Highmark Blue Shield also provides services in conjunction with a separate health plan in southeastern Pennsylvania.  Highmark Inc. or certain of its affiliated Blue companies also serve Blue Cross Blue Shield members in 29 counties in western Pennsylvania, 13 counties in northeastern Pennsylvania, the state of West Virginia plus Washington County, Ohio, the state of Delaware[ and [8] counties in western New York and Blue Shield members in [13] counties in northeastern New York].  All references to Highmark in this document are references to Highmark Inc. d/b/a Highmark Blue Shield and/or to one or more of its affiliated Blue companies.





Medical policies do not constitute medical advice, nor are they intended to govern the practice of medicine. They are intended to reflect reimbursement and coverage guidelines. Coverage for services may vary for individual members, based on the terms of the benefit contract.

Discrimination is Against the Law
The Claims Administrator/Insurer complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability, or sex. The Claims Administrator/Insurer does not exclude people or treat them differently because of race, color, national origin, age, disability, or sex. The Claims Administrator/ Insurer:

  • Provides free aids and services to people with disabilities to communicate effectively with us, such as:
  • Qualified sign language interpreters
  • Written information in other formats (large print, audio, accessible electronic formats, other formats)

  • Provides free language services to people whose primary language is not English, such as:
  • Qualified interpreters
  • Information written in other languages
  • If you need these services, contact the Civil Rights Coordinator.

    If you believe that the Claims Administrator/Insurer has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability, or sex, you can file a grievance with: Civil Rights Coordinator, P.O. Box 22492, Pittsburgh, PA 15222, Phone: 1-866-286-8295 , TTY: 711, Fax: 412-544-2475, email: CivilRightsCoordinator@highmarkhealth.org. You can file a grievance in person or by mail, fax, or email. If you need help filing a grievance, the Civil Rights Coordinator is available to help you.

    You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at:

    U.S. Department of Health and Human Services
    200 Independence Avenue, SW
    Room 509F, HHH Building
    Washington, D.C. 20201
    1-800-368-1019, 800-537-7697 (TDD)

    Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html.