HCPCS Code J1306: Injection, inclisiran, 1 mg

Learn about HCPCS Code J1306 for injection inclisiran 1 mg to treat LDL-C in high-risk patients. Documentation tips included.

Use Code

What is injection, inclisiran, 1 mg?

Injection, inclisiran, 1 mg refers to a cholesterol-lowering drug used to manage patients with elevated LDL-C (low-density lipoprotein cholesterol), particularly those with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD). Inclisiran is a small interfering RNA (siRNA) medication that works by inhibiting the production of PCSK9, a protein that limits the liver’s ability to remove LDL-C from the blood.

This subcutaneous drug is administered via injection and is designed for long-term LDL-C control, with its effect maintained through twice-yearly dosing after initial loading doses. Inclisiran is unique in its mechanism, providing consistent LDL-C reduction in the absence of daily pills and with minimal variability between injections.

It is indicated for adults in the presence of high cardiovascular risk, especially when additional LDL-C lowering is needed beyond lifestyle changes and statin therapy. Inclisiran is typically used in combination with statins and other lipid-lowering treatments to help patients reach target cholesterol levels more effectively.

By using this drug, healthcare providers can improve cholesterol management outcomes for patients with genetic lipid disorders such as heterozygous familial hypercholesterolemia, while reducing treatment burden through less frequent subcutaneous administration.

J1306 documentation requirements

When billing HCPCS Code J1306 for Injection, inclisiran, 1 mg, proper documentation is essential to ensure compliance, support medical necessity, and secure reimbursement. Key documentation information includes:

Confirm diagnosis, such as heterozygous familial hypercholesterolemia or ASCVD.
Include evidence of poor LDL-C control despite statin use or intolerance.
Document medical necessity based on patient risk and treatment history.
Justify the use of inclisiran over other therapies.
Note if subcutaneous injection is preferred or required.
Record drug name, dose in mg, and lot number.
Specify route of administration and injection site.
Include date, time, and provider details.
Outline dosing schedule and follow-up plan.
Document LDL-C monitoring and any side effects.
Confirm patient consent and education provided.

Billing-specific requirements

Proper billing for J1306 requires accurate dosage details, correct modifiers, and adherence to payer-specific rules to ensure valid reimbursement.

Include appropriate modifiers, if applicable (e.g., JZ for no discarded drug).
Confirm that the documentation supports units billed (e.g., total mg administered matches quantity billed under J1306).
Note any payer-specific prior authorization numbers or coverage criteria met.

Other relevant codes

J1745 – Infliximab, 10 mg (for different formulations)
J1599 – Unclassified biologic drug

Frequently asked questions

Injection inclisiran 1 mg is a prescription medication used to lower LDL-C (bad cholesterol) in adults with conditions like heterozygous familial hypercholesterolemia or clinical ASCVD. It’s administered subcutaneously and is typically used alongside statins.

Common effects may include injection site reactions, mild muscle pain, or flu-like symptoms. Serious side effects are rare.

HCPCS code J1306 became effective in July 2022. Since then, it has supported cholesterol management in eligible patients.