Friday, January 27, 2017

cpt code j3489, j1436, J2326 - Bisphosphonate Drug Therapy

CPT/HCPCS Codes

Group 1 Codes:

J1436 INJECTION, ETIDRONATE DISODIUM, PER 300 MG

J1740 INJECTION, IBANDRONATE SODIUM, 1 MG

J2430 INJECTION, PAMIDRONATE DISODIUM, PER 30 MG

J3489 INJECTION, ZOLEDRONIC ACID, 1 MG

Uhc Guideline

The following list(s) of codes is provided for reference purposes only and may not be all inclusive. Listing of a code in this guideline does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee claim payment. Other Policies and Guidelines may apply.


HCPCS Code Description

J3489 Injection, zoledronic acid, 1 mg

Coverage Indications, Limitations, and/or Medical Necessity


Q2051 J3489 Injection, Zoledronic Acid, 1mg K 1356 


Bisphosphonate drugs act to inhibit normal and abnormal bone reabsorption. This action is helpful in reducing pain, reversing hypercalcemia, preventing and reducing fractures in a range of diseases that directly or indirectly impact bone modeling and remodeling.

Bisphosphonates are available in both oral and parenteral forms. Coverage is limited to those drugs administered parenterally (IV). Bisphosphonates are indicated parenterally when the patient has failed a trial of the oral drug or has insurmountable issues related to absorption, compliance or dosing posture.

Etidronate disodium IV, Pamidronate disodium IV, and Zoledronic acid IV, are covered for the following indications:

Hypercalcemia associated with malignancy

Osteoclastic hyperactivity resulting in excessive bone resorption is the underlying complication with metastatic bone disease and hypercalcemia associated with malignancy. Most cases of hypercalcemia, associated with malignancy, occurs in patients who have breast cancer, squamous-cell tumors of the lung or head and neck, renal-cell carcinoma, and certain hematologic malignancies (multiple myeloma and some types of lymphomas). Bisphosphonates, in conjunction with hydration, are indicated for moderate or severe hypercalcemia associated with malignancy with or without bone metastases.

Cancer Treatment-Induced Bone Loss (CTIBL) in Breast and Prostate Cancer

Breast Cancer

Cytotoxic chemotherapy: There are 2 mechanisms of cytotoxic chemotherapy inducing bone loss. First, there is a direct negative effect of the cytotoxic therapy on bone cells, predominantly osteoblasts and, second, many women who are premenopausal have cytotoxic therapy effects on ovarian function, which results in gonadal loss. In addition, in premenopausal women, surgery (oophorectomy) or radiation therapy to the ovary results in bone loss. Hormone therapy, tamoxifen in premenopausal women, and the aromatase inhibitors result in bone loss, as well as gonadotropin-releasing hormone (GnRH) antagonists/agonists, which shut off ovarian function. All of these result in estrogen depletion.

Prostate Cancer

In prostate cancer, cytotoxic therapy again has a negative effect not only on testicular function but also on bone. Surgical therapy, hormone therapy, including antiandrogens and GnRH agonists/antagonists, results in androgen depletion. The final common pathway, estrogen and androgen depletion, results in a decrease in bone mineral density.

Bone metastases secondary to solid tumors, breast cancer, and prostate cancer

Multiple Myeloma

Osteolytic lesions due to metastases

Paget’s Disease of bone (osteitis deformans)

Intravenous bisphosphonates are indicated for moderate to severe Paget’s disease of bone.

Prophylaxis and treatment of heterotopic ossification associated with spinal cord injury, traumatic brain injury, hip replacement, and burns
It is indicated parenterally when the patient has failed a trial of the oral drug or has insurmountable issues related to absorption, compliance or dosing posture.

Besides the indication listed above, Pamidronate Sodium is covered for the following indications:
Osteogenesis Imperfecta

Fibrous dysplasia of bone (McCune-Albright syndrome)

Ibandronate sodium, Pamidronate or Zoledronic acid are covered for the following additional indication:
Treatment of osteoporosis when there is no drug classification contraindications. There also needs to exist either one or more of the following:
Demonstrated intolerance or contraindication for FDA approved oral bisphosphonates dosing regimens, or insurmountable issues related to absorption, compliance or dosing posture.

When adequate trials of FDA-approved oral bisphosphonates result in fallen Bone Mass Density and/or failure to suppress bone turnover (e.g. persisting high bone -turnover marker measurements).

Evidence in the medical record should clearly support the need for the intravenous administration of bisphosphonates for the treatment of osteoporosis.

Ibandronate sodium is covered for:
Hypercalcemia associated with malignancy

Bone metastases secondary to solid tumors, breast cancer, prostate cancer

Zoledronic acid - Injection is covered for the treatment of:
Paget's disease of bone in men and women.

Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease, to induce remission (normalization of serum alkaline phosphatase).

This contractor will cover zoledronic acid at most once per year because after a single treatment with zoledronic acid in Paget’s disease, an extended remission period is observed. Re-treatment with zoledronic acid may be considered, after one year in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.




Drug Therapy Guidelines

I. Medication Description

Spinraza is an antisense oligonucleotide (ASO) designed to treat spinal muscular atrophy (SMA) caused by mutations in the chromosome 5q that lead to survival motor neuron (SMN) protein deficiency. Using in vitro assays and studies in transgenic animal models of SMA, Spinraza was shown to increase exon 7 inclusion in SMN2 messenger ribonucleic acid (mRNA) transcripts and production of full-length SMN protein.

II. Position Statement Coverage is determined through a prior authorization process with supporting clinical documentation for every request.

III. Policy Coverage of Spinraza is provided when the following criteria are met:
• The prescriber specializes in the treatment of spinal muscular atrophy (SMA) AND
• The patient has been diagnosed with type I, II, or III SMA AND
• The patient has had a genetic test that confirms the diagnosis of 5q SMA by homozygous gene deletion, homozygous mutation, or compound heterozygous mutation

IV. Quantity Limitations
• Induction: 12 mg (5 mL) IV at weeks 0, 2, 4, and 8
• Maintenance: 12 mg (5 mL) IV every 4 months

V. Coverage Duration Coverage is provided for 6 months and may be renewed.

VI. Coverage Renewal Criteria Coverage can be renewed based upon the following criteria:
• Stabilization of disease or in absence of disease progression AND
• Absence of unacceptable toxicity from the drug

VII. Billing/Coding Information
• J2326: 1 billable unit = 0.1 mg
• Available as 12 mg/5 mL single-dose glass vials


ICD-10 Codes that Support Medical Necessity

Group 1 Paragraph: Note: Diagnosis codes must be coded to the highest level of specificity.

J1436 Etidronate disodium



Group 1 Codes:

ICD-10 CODE DESCRIPTION

C79.51* Secondary malignant neoplasm of bone

C79.52* Secondary malignant neoplasm of bone marrow

C90.00 Multiple myeloma not having achieved remission
C90.01 Multiple myeloma in remission

C90.02 Multiple myeloma in relapse

E83.52 Hypercalcemia

M61.011 Myositis ossificans traumatica, right shoulder

M61.012 Myositis ossificans traumatica, left shoulder

M61.021 Myositis ossificans traumatica, right upper arm

M61.022 Myositis ossificans traumatica, left upper arm

M61.031 Myositis ossificans traumatica, right forearm

M61.032 Myositis ossificans traumatica, left forearm

M61.041 Myositis ossificans traumatica, right hand

M61.042 Myositis ossificans traumatica, left hand

M61.051 Myositis ossificans traumatica, right thigh

M61.052 Myositis ossificans traumatica, left thigh

M61.061 Myositis ossificans traumatica, right lower leg

M61.062 Myositis ossificans traumatica, left lower leg

M61.071 Myositis ossificans traumatica, right ankle and foot

M61.072 Myositis ossificans traumatica, left ankle and foot

M61.08 Myositis ossificans traumatica, other site

M61.09 Myositis ossificans traumatica, multiple sites

M61.111 Myositis ossificans progressiva, right shoulder

M61.112 Myositis ossificans progressiva, left shoulder

M61.121 Myositis ossificans progressiva, right upper arm

M61.122 Myositis ossificans progressiva, left upper arm

M61.131 Myositis ossificans progressiva, right forearm
M61.132 Myositis ossificans progressiva, left forearm

M61.141 Myositis ossificans progressiva, right hand

M61.142 Myositis ossificans progressiva, left hand

M61.144 Myositis ossificans progressiva, right finger(s)

M61.145 Myositis ossificans progressiva, left finger(s)

M61.151 Myositis ossificans progressiva, right thigh

M61.152 Myositis ossificans progressiva, left thigh

M61.161 Myositis ossificans progressiva, right lower leg

M61.162 Myositis ossificans progressiva, left lower leg

M61.171 Myositis ossificans progressiva, right ankle

M61.172 Myositis ossificans progressiva, left ankle

M61.174 Myositis ossificans progressiva, right foot

M61.175 Myositis ossificans progressiva, left foot

M61.177 Myositis ossificans progressiva, right toe(s)

M61.178 Myositis ossificans progressiva, left toe(s)

M61.18 Myositis ossificans progressiva, other site

M61.19 Myositis ossificans progressiva, multiple sites

M61.211 Paralytic calcification and ossification of muscle, right shoulder

M61.212 Paralytic calcification and ossification of muscle, left shoulder

M61.221 Paralytic calcification and ossification of muscle, right upper arm

M61.222 Paralytic calcification and ossification of muscle, left upper arm

M61.231 Paralytic calcification and ossification of muscle, right forearm

M61.232 Paralytic calcification and ossification of muscle, left forearm

M61.241 Paralytic calcification and ossification of muscle, right hand

M61.242 Paralytic calcification and ossification of muscle, left hand

M61.251 Paralytic calcification and ossification of muscle, right thigh

M61.252 Paralytic calcification and ossification of muscle, left thigh

M61.261 Paralytic calcification and ossification of muscle, right lower leg

M61.262 Paralytic calcification and ossification of muscle, left lower leg

M61.271 Paralytic calcification and ossification of muscle, right ankle and foot

M61.272 Paralytic calcification and ossification of muscle, left ankle and foot

M61.28 Paralytic calcification and ossification of muscle, other site

M61.29 Paralytic calcification and ossification of muscle, multiple sites

M88.0 Osteitis deformans of skull

M88.1 Osteitis deformans of vertebrae

M88.811 Osteitis deformans of right shoulder

M88.812 Osteitis deformans of left shoulder

M88.821 Osteitis deformans of right upper arm

M88.822 Osteitis deformans of left upper arm

M88.831 Osteitis deformans of right forearm

M88.832 Osteitis deformans of left forearm

M88.841 Osteitis deformans of right hand

M88.842 Osteitis deformans of left hand

M88.851 Osteitis deformans of right thigh

M88.852 Osteitis deformans of left thigh

M88.861 Osteitis deformans of right lower leg

M88.862 Osteitis deformans of left lower leg

M88.871 Osteitis deformans of right ankle and foot

M88.872 Osteitis deformans of left ankle and foot

M88.88 Osteitis deformans of other bones

M88.89 Osteitis deformans of multiple sites

M89.9* Disorder of bone, unspecified

M94.9* Disorder of cartilage, unspecified


T79.6XXA Traumatic ischemia of muscle, initial encounter
T79.6XXD Traumatic ischemia of muscle, subsequent encounter

T79.6XXS Traumatic ischemia of muscle, sequela

Z79.811* Long term (current) use of aromatase inhibitors

Z79.899* Other long term (current) drug therapy

Z85.3* Personal history of malignant neoplasm of breast

Z85.46* Personal history of malignant neoplasm of prostate

Group 1 Medical Necessity ICD-10 Codes Asterisk Explanation: *For C79.51 and C79.52, see Documentation Requirements



*For treatment of bone loss in woman receiving adjuvant aromatase inhibitor therapy for breast cancer, ICD-10 code M89.9 or M94.9 must be reported with Z85.3 and Z79.811.


*For treatment of bone loss in men receiving androgen deprivation therapy for nonmetastatic prostate cancer, ICD-10 M89.9 or M94.9 must be reported with Z85.46 and Z79.899.


Frequency Editing

By definition, HCPCS codes S9123 (nursing care, in the home; by registered nurse, per hour) and/or S9124 (Nursing care, in the home; by licensed practical nurse, per hour) are reported on a once per hour basis. Since a day consists of 24 hours, the maximum number of reported hours/units would be 24 per date of service for a code that includes “per hour” in the definition. Therefore, for claims processed on or after November 16, 2015 we implemented a frequency maximum of 24
hours/units per date of service for HCPCS codes S9123 and/or S9124.

In addition, we added J2505 (injection, pegfilgrastim, 6 mg (Neulasta)) to our code table to support our current frequency limit of 1 per date of service.

Beginning with dates of service on or after March 1, 2016, we will apply a frequency limit of one unit per 60 days for CPT codes 11720 (Debridement of nail(s) by any method(s); 1 to 5) and/or 11721 (Debridement of nail(s) by any method(s); 6 or more). This frequency limit is in agreement with the Centers for Medicare & Medicaid Services (CMS) 60-day limitation for these codes. This edit will use claim lines processed in history that have previous, current, and subsequent dates of service
to accumulate and apply this frequency limit.

Effective for dates of service on or after March 1, 2016, we are adding frequency limits to the drugs listed in the table below. These limits are based on FDA approval and/or manufacturers’ dosage guidelines. Unless otherwise noted, these maximums are per date of service


Enhanced reimbursement available for certain Part B injectable drugs

Beginning 1Q16, Empire individual Medicare Advantage plans will reimburse providers with enhanced payments for using less expensive but therapeutically equivalent select Part B injectable drugs. The reimbursement change is specific to only the following drugs.

 Therapeutic Class – Antiemetics. HCPCS (drug) – J1626 (Kytril), J2405 (Zofran)

 Therapeutic Class – Folinic Acid. HCPCS (drug) – J0640 (Leucovorin)

 Therapeutic Class – Osteoporosis. HCPCS (drug) – J3489 (Reclast)

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