Centene dalteparin Coverage & Prior Auth

Coverage and Medical Necessity Criteria

Initial Therapy — Covered when ANY of the following indication categories are met and all listed subcriteria (where present) are satisfied:

Covered when ANY of the following indication categories are met and all listed subcriteria (where present) are satisfied:

Initial Indication Categories

A Thrombosis/Thromboembolism: Thrombosis or thromboembolism prevention associated with one or more of the following conditions: cancer (see Appendix D); atrial fibrillation or prosthetic heart valve; unstable angina or myocardial infarction; major surgery (orthopedic or non-orthopedic); restricted mobility associated with acute illness; critical illness/ICU admission; implanted vascular devices (including central venous access devices, umbilical venous catheters, hemodialysis access devices, ventricular assist devices). Short-term prophylaxis for transition to/from oral anticoagulation is included.
B Thrombosis/Thromboembolism Treatment: Thrombosis or thromboembolism treatment (includes cancer-associated VTE treatment when dalteparin is indicated).
A trial of enoxaparin is required prior to dalteparin unless: (1) enoxaparin is contraindicated, (2) history of clinically significant adverse effects to enoxaparin, or (3) the requested use is FDA labeled for dalteparin but not enoxaparin (e.g., VTE treatment in patients with cancer; treatment of symptomatic VTE in pediatrics).

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Initial Therapy — Initial authorization requires meeting one of the indication categories and associated subcriteria:

Initial authorization requires meeting one of the indication categories and associated subcriteria:

Initial Dalteparin Use: Coverage requested for initial therapy when member meets prevention (see A) or treatment (see B) categories in section I.

Enoxaparin trial required unless contraindicated, adverse reaction to enoxaparin, or the request is for an FDA-labeled dalteparin use not labeled for enoxaparin.

Anticoagulation in Pregnancy (Off-label) — Off-label antenatal and postpartum anticoagulation with dalteparin may be covered when ALL criteria are met:

Off-label antenatal and postpartum anticoagulation with dalteparin may be covered when ALL criteria are met:

Pregnancy Indications: Member is pregnant or within 6 months postpartum AND has at least one qualifying indication: acute venous thrombosis during the current pregnancy; prior venous thrombosis; prosthetic heart valve; receiving long-term vitamin K antagonist therapy (e.g., warfarin); inherited thrombophilia; antiphospholipid antibody syndrome; development of severe ovarian hyperstimulation syndrome after assisted reproduction; or cesarean section in the current pregnancy when the request is for the postpartum period.

Approval durations: antepartum to estimated delivery date; postpartum up to 6 months (varies by line of business and refer to HIMPA.103 for Fragmin 95,000 units/3.8 mL).

Covered Indications and Dosing

Covered when ALL of the following are met for the specific indication:

Extended treatment of VTE in cancer: Adults: Month 1: 200 IU/kg subcutaneously once daily; Months 2–6: 150 IU/kg subcutaneously once daily.dose schedule

Per Appendix D and NCCN recommendations.

DVT prophylaxis in adults (medical/surgical/hip/abdominal): Use indicated prophylactic regimens, for example: medical prophylaxis 5,000 IU SC once daily; abdominal/hip surgery perioperative regimens such as 2,500 IU SC preoperative or postoperative followed by 5,000 IU SC once daily per dosing appendix.regimen-specific

See dosing appendix for specific pre/postoperative timing.

Treatment of VTE in pediatric patients: Starting doses by age: birth (gestational age ≥35 weeks) to <2 years: 150 IU/kg SC twice daily; 2 to <8 years: 125 IU/kg SC twice daily; 8 to <17 years: 100 IU/kg SC twice daily. Whenever possible, use benzyl alcohol–free (preservative-free) formulations for neonates and pediatrics.

Requests for dalteparin (Fragmin) for non–FDA approved indications that are not specifically addressed in this policy will not be authorized unless the provider submits sufficient supporting documentation of efficacy and safety in accordance with the applicable off‑label use policies. Refer to CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid when seeking coverage for off‑label uses.

Dalteparin is contraindicated and should not be used in patients with active major bleeding, a history of heparin‑induced thrombocytopenia (HIT) or HIT with thrombosis, or in patients with known hypersensitivity to dalteparin, heparin, or pork products. Do not administer dalteparin to patients undergoing epidural or neuraxial anesthesia due to risk of spinal/epidural hematomas. These contraindications may result in denial of a prior authorization request.

Per the product labeling and policy guidance, Fragmin is not indicated for the acute treatment of venous thromboembolism (VTE). Additionally, use of dalteparin for prolonged VTE prophylaxis in contexts listed as contraindications is not supported by this policy and may be excluded from coverage.

Dalteparin is explicitly listed as not indicated for use as a treatment for unstable angina and non‑Q‑wave myocardial infarction. Requests for dalteparin for these cardiac indications are contraindicated per the policy and product labeling.

Initial Authorization Criteria

Initial Therapy — Initial authorization requires meeting one of the indication categories and associated subcriteria:

Initial authorization requires meeting one of the indication categories and associated subcriteria:

Initial Dalteparin Use: Coverage requested for initial therapy when member meets prevention (see A) or treatment (see B) categories in section I.

Enoxaparin trial required unless contraindicated, adverse reaction to enoxaparin, or the request is for an FDA-labeled dalteparin use not labeled for enoxaparin.

Initial Therapy — Initial and acute treatment dosing where specified

Initial and acute treatment dosing where specified:

Initial pediatric treatment: Use age/weight-based BID dosing as listed: birth (≥35 weeks gestational age) to <2 years: 150 IU/kg SC twice daily; 2 to <8 years: 125 IU/kg SC twice daily; 8 to <17 years: 100 IU/kg SC twice daily. Whenever possible administer benzyl alcohol–free formulations.age-based

Criteria for Continued Coverage

Continuation Therapy — Continued therapy is covered when criteria for continuation are met:

Continued therapy is covered when criteria for continuation are met:

Continued Therapy General: Member is currently receiving dalteparin via a Centene benefit or previously met initial approval criteria; member is responding positively to therapy; and if applicable the member is enrolled in a state/product with continuity of care regulations.

Continued use is limited to indications listed (e.g., cancer-associated VTE) and duration rules apply per line of business (typically up to 6 months; see policy for exceptions).

Continuation Therapy — Criteria for continued coverage

Criteria for continued coverage

Continued Dalteparin Use: Member is currently receiving dalteparin via Centene benefit or previously met initial approval criteria; member is clinically responding to therapy; continued use is limited to approved indications (e.g., cancer-associated VTE) and duration limits per line of business apply.

Approval durations: Commercial/HIM/Medicaid commonly 6 months or per renewal/continuity rules; see Section II and HIMPA.103 when applicable.

Step Therapy and Therapeutic Alternatives

Provider action: Prior authorization and coding
No results

Provider action: Required clinical documentation
No results

Step Therapy

Therapeutic alternatives / Step options

Therapeutic alternatives should be considered and trialed per Appendix B prior to approving dalteparin unless contraindicated. A trial of enoxaparin is required prior to dalteparin approval unless there is documented: contraindication to enoxaparin, history of clinically significant adverse effect to enoxaparin, or an FDA-labeled indication for dalteparin that does not apply to enoxaparin (e.g., some cancer-associated VTE or pediatric indications).

Preferred alternative: enoxaparin (Lovenox) — use per dosing in Appendix B and institutional formulary prior to dalteparin when clinically appropriate.
If enoxaparin trial not possible, include clear documentation of contraindication, adverse reaction, or FDA-labeled indication for dalteparin in the PA submission.

Authorization, Documentation, and Billing Actions for Providers

Prior Authorization

Prior authorization required; approval tied to initial criteria

Prior authorization is required for dalteparin; approval will be granted only when the member meets the specified initial criteria in Section I (indication categories and associated subcriteria).

Initial approval requires meeting one of the indication categories and all listed subcriteria.

Billing Rule

PA and billing: use HCPCS J1645 for dalteparin

Prior authorization is required for dalteparin product requests and claims should reference HCPCS code J1645 (Injection, dalteparin sodium, per 2500 IU).

Use HCPCS J1645 for dalteparin billing per the policy's coding implications.

Billing Codes and Pediatric Dosing Thresholds

HCPCS CodesHCPCS

J1645

Injection, dalteparin sodium, per 2500 IU

Pediatric age dosing thresholds — IU/kg BID dosing

Birth to <2 years150 IU/kg subcutaneously twice daily (for neonates ≥35 weeks gestational age)

2 to <8 years125 IU/kg subcutaneously twice daily

8 to <17 years100 IU/kg subcutaneously twice daily

Quantity Limit Information

Dalteparin — product & quick-reference

Available presentationsSingle-dose graduated syringe 10,000 IU/mL; multiple-dose vial 95,000 IU/3.8 mL; single-dose vial 10,000 IU/4 mL

Newly approved strength10,000 IU/4 mL (2,500 IU/mL) single-dose vial — preservative-free

HCPCS coding reminderUse HCPCS J1645 (injection, dalteparin sodium, per 2500 IU) on claims and prior authorization requests

Quantity limitsPer policy product availability lists vial and syringe sizes; specific per-member quantity limits not specified in document — use dosing schedule and clinical need

Site of Care and Setting Guidance

Note

Site-of-care: inpatient and outpatient use with perioperative timing guidance

Dalteparin may be used in inpatient and outpatient settings; specific perioperative timing is provided for surgical prophylaxis and outpatient ambulatory use in the dosing appendices.

Perioperative dosing and timing (preoperative and postoperative start times) are specified for hip and abdominal surgery in the dosing sections.
Outpatient ambulatory and hospital settings are addressed in Appendix D for cancer-associated VTE guidance.

Background and Definitions

Dalteparin (Fragmin) is a low molecular weight heparin (LMWH) anticoagulant used for prophylaxis and treatment of venous thromboembolism (VTE) in specific populations. Labeled adult indications include prophylaxis of DVT in surgical and medically ill patients, and an extended six‑month regimen to reduce VTE recurrence in adults with cancer. Fragmin is indicated for treatment of symptomatic VTE in pediatric patients from birth when gestational age is ≥35 weeks. The product is not indicated for the acute treatment of VTE; boxed warnings and contraindications include risk of spinal/epidural hematomas and exclusion in patients with active major bleeding or HIT.

Low molecular weight heparin (LMWH) — definition

DefinitionLow molecular weight heparin (LMWH): a class of anticoagulant derived from heparin; dalteparin (Fragmin) is an LMWH used for VTE prophylaxis and treatment

Common abbreviationsLMWH = low molecular weight heparin; used throughout dosing and appendix guidance

Clinical contextLMWHs are used for prevention and treatment of venous thromboembolism including DVT and PE

Venous thromboembolism (VTE) — definition

Policy Revision History

2024-10-18material_changeLatest

Added newly approved pediatric extension allowing treatment of symptomatic venous thromboembolism from birth (gestational age ≥35 weeks); Appendix D and references updated.

2022-11-21material_change

Added newly approved 10,000 IU/4 mL (2,500 IU/mL) dosage strength and updated Appendix D with current NCCN compendium language; references reviewed and updated.

2023-10-31update

OpenPayer

Dalteparin (Fragmin) coverage and prior authorization

Related Billing Codes