## **What is HCPCS code A9513?**
HCPCS code A9513 is designated for "Lutetium Lu 177, dotatate, therapeutic, 1 millicurie." This code falls under the category of Diagnostic and Therapeutic Radiopharmaceuticals as maintained by CMS. Lutetium Lu 177 dotatate, commercially known as Lutathera, is a radiopharmaceutical used in targeted cancer therapy, specifically for treating certain types of neuroendocrine tumors.
The code is used to bill for the therapeutic radioactive drug in units of millicurie (mCi), where each unit corresponds to one millicurie of the drug. It was established to provide a standardized coding and billing mechanism for this advanced treatment in hospital outpatient and other applicable settings.
CMS assigns this code for Medicare claims processing, ensuring appropriate reimbursement for this costly and highly specialized product. Accurate coding requires complete information, including dosage, tumor size, concomitant medications, and specific instructions for administration. Clinical documentation often includes confirming a positive somatostatin receptor status, as well as monitoring for renal toxicity and other adverse events to ensure patient safety.
This code is an essential part of coding compliance and accurate reporting for Lutetium Lu 177 dotatate (Lutathera) when administered intravenously for patients with somatostatin receptor–positive tumors.
## **HCPCS code A9513 documentation requirements**
Proper documentation is essential when billing for HCPCS code A9513 (Lutetium Lu 177 dotatate therapeutic, per 1 millicurie). Because this is a high-cost radiopharmaceutical used in treating gastroenteropancreatic neuroendocrine tumors (GEP-NETs), payers require detailed records to verify medical necessity, treatment appropriateness, and compliance with prior authorization rules.
### **Specialist supervision**
The medication must be administered under the direct supervision of an oncologist or nuclear medicine specialist who is authorized to prescribe and oversee radiopharmaceutical therapy.
### **Prior authorization**
For dates of service on or after October 1, 2019, a completed Special Medical Prior Authorization (SMPA) Request Form is required. This form must be signed by the prescribing provider and submitted to the payer for review before treatment begins.
### **Medical necessity criteria**
The SMPA form and supporting documentation must establish medical necessity by including the following criteria:
- Client dosage and dosage calculation
- Administration schedule and number of injections within the authorization period
- Requested units/millicuries per injection
- Confirmation that the client has a diagnosis of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) verified by pathology reports and imaging
- Confirmation that the client is 18 years or older, not pregnant, and not breastfeeding
### **Treatment history**
Documentation must demonstrate disease progression on somatostatin analog therapy and confirm that the client has not received prior Peptide Receptor Radionuclide Therapy (PRRT) or extensive prior radiation to the bone marrow.
### **Physician order and treatment plan**
Include a complete written order and prescription for Lutetium Lu 177 dotatate intravenous infusion, signed by an authorized physician. The treatment plan should specify:
- Dosage of 7.4 GBq (200 mCi) every 60 days for four doses
- Physician oversight of therapy
- Planned premedications, management of side effects, and monitoring instructions
### **Clinical monitoring and withholding criteria**
Medical records must address withholding criteria such as thrombocytopenia, anemia, neutropenia, and renal or liver toxicity. Document any modifications or treatment holds due to adverse events.
## **HCPCS code A9513 billing requirements**
Accurate billing is critical for HCPCS code A9513, given the high cost and clinical significance of Lutetium Lu 177 dotatate therapy. Claims must reflect the exact dose administered, include the correct provider information, and follow payer-specific submission rules to avoid delays or denials.
- Report HCPCS code A9513 per 1 millicurie of Lutetium Lu 177 dotatate administered, with units matching the exact dosage given.
- Include the ordering or referring physician’s name and NPI on the claim form.
- Reflect the acquisition cost of the drug and any applicable pharmacy or nuclear medicine handling fees in the charges.
- Report the appropriate diagnosis codes (ICD-10) that support medical necessity and match the documentation on file.
- Append the correct modifiers, such as JZ (no wastage) or JW (drug amount discarded), when applicable.
- Submit with the appropriate administration CPT code, such as 79101 for intravenous infusion, on the same claim.
- Bill through the correct setting: hospitals submit to the Part A intermediary for inpatient or outpatient services, while non-hospital providers bill under Part B.
Note that Medicare typically reimburses around $300–$350 per millicurie unit, though rates may vary by payer.
## **Other relevant codes**
- **A9512**: Technetium Tc-99m pertechnetate, diagnostic, per millicurie
- **A9515**: Choline C-11, diagnostic, per study dose up to 20 millicuries
Frequently asked questions
