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Which CPT Codes are Used in Biologics and Specialty Drugs Billing?

Biologics and Speciality Drugs Billing

BiologicsBiologics and specialty drugs represent some of the most innovative and complex pharmaceuticals available today. They are used to treat a wide range of diseases and conditions, from cancers to autoimmune disorders. However, these cutting-edge medications also come with high price tags and complex administration requirements.

One of the tools used to properly bill and reimburse providers for biologics and specialty drugs is the Current Procedural Terminology (CPT) code set maintained by the American Medical Association. CPT codes provide a systematic way to describe medical, surgical, and diagnostic services provided by physicians and other healthcare professionals. Having a solid understanding of the correct CPT codes to use for biologics and specialty drugs is critical for proper reimbursement.

What are Biologics and Specialty Drugs?

Biologics refer to medicines that are made from living organisms or contain components of living organisms. They include a wide range of products such as vaccines, blood and blood products, allergenics, somatic cells, gene therapies, tissues, and recombinant therapeutic proteins. Biologics can treat diseases and conditions such as cancer, rheumatoid arthritis, inflammatory bowel disease, and multiple sclerosis.

Some of the best known biologic drugs include Humira (adalimumab), Rituxan (rituximab), Enbrel (etanercept), and Remicade (infliximab). These complex, large molecule drugs are often administered by injection or infusion.

Specialty drugs is a broader term that includes biologics as well as other high-cost medicines that often require special handling and administration. In addition to biologics, specialty drugs may include drugs for multiple sclerosis, hepatitis C, cancer, rheumatoid arthritis, HIV, and other complex conditions.

Some features that characterize specialty drugs include:

  • Require frequent dosage adjustments
  • Need special storage, handling, and administration
  • Have strict requirements for provider/pharmacy credentialing
  • Involve extensive patient monitoring and education
  • May have limited distribution networks
  • Have REMS (Risk Evaluation and Mitigation Strategies) in place

Both biologics and specialty drugs require providers to have deep knowledge and capabilities to store, administer, and monitor them properly. Their complexity is also reflected in the intricate CPT coding required.

CPT Codes for Injectable / Infusible Biologics and Specialty Drugs

A significant portion of the CPT codes relevant to biologics and specialty drugs involve those administered by injection or infusion.

The codes fall under several main subsections:

Immune Globulins

Immune globulin biologics are processed plasma proteins that contain antibodies to help fight infections and immune disorders.

There are several CPT codes for immune globulin administration:

  • 90281 – Immune globulin, human, for intramuscular use
  • 90283 – Immune globulin, human, intravenous, for use in primary immune deficiency diseases, 100 mg, each
  • 90284 – Immune globulin, human, 10 mg, intravenous administration
  • 90399 – Unlisted immune globulin

Monoclonal Antibodies

Monoclonal antibodies are biologics that contain copies of a specific antibody. They work by targeting specific proteins or antigens.

CPT codes for monoclonal antibody administration include:

  • 96401 – Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic
  • 96402 – Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-neoplastic
  • 96405 – Chemotherapy administration; intralesional, up to and including 7 lesions
  • 96406 – Chemotherapy administration; intralesional, more than 7 lesions
  • 96409 – Chemotherapy administration; intravenous, push technique, single or initial substance/drug
  • 96411 – Chemotherapy administration; intravenous, push technique, each additional substance/drug
  • 96413 – Chemotherapy administration, intravenous infusion technique; up to 1 hour, single or initial substance/drug
  • 96415 – Chemotherapy administration, intravenous infusion technique; each additional hour (List separately in addition to code for primary procedure)
  • 96417 – Chemotherapy administration, intravenous infusion technique; each additional sequential infusion (different substance/drug), up to 1 hour (List separately in addition to code for primary procedure)

Enzyme-Related Biologics

Enzyme biologics replace enzymes that are deficient or absent in people with certain conditions.

CPT codes include:

  • 90746 – Infusion, enzyme-related biologic, 1 mg

Cytokines and Other Biologics

Cytokines and additional biologics help regulate the immune system.

Their CPT codes are:

  • 96365 – Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); initial, up to 1 hour
  • 96366 – Intravenous infusion, for therapy, prophylaxis, or diagnosis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure)
  • 96369 – Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); initial, up to 1 hour, including pump set-up and establishment of subcutaneous infusion site(s)
  • 96370 – Subcutaneous infusion for therapy or prophylaxis (specify substance or drug); each additional hour (List separately in addition to code for primary procedure)
  • 90772 – Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular
  • J0129 – Injection, abatacept, 10 mg
  • J0135 – Injection, adalimumab, 20 mg
  • J1438 – Injection, etanercept, 25 mg (code for Enbrel)
  • J1602 – Injection, golimumab, 1 mg, for intravenous use (code for Simponi Aria)
  • J1745 – Injection, infliximab, excludes biosimilar, 10 mg (code for Remicade)
  • J2323 – Injection, natalizumab, 1 mg (code for Tysabri)
  • J3358 – Ustekinumab, for intravenous injection, 1 mg (code for Stelara intravenous)

Hemophilia Clotting Factors

Hemophilia clotting factors replace missing or deficient blood proteins.

CPT codes cover factors VIII and IX:

  • 90740 – Zoster immune globulin, human, for intramuscular use
  • 90743 – Hepatitis B immune globulin (HBIg), human, for intramuscular use
  • 90744 – Injection, hemophilia factor VIII (antihemophilic factor, recombinant), per I.U.
  • 90791 – Factor VIIa (antihemophilic factor, recombinant), per 1 mcg
  • 90792 – Factor VIII (antihemophilic factor, recombinant) (Xyntha), per IU
  • 90794 – Factor IX (antihemophilic factor, recombinant), per IU, not otherwise specified
  • J7192 – Factor VIII recombinant, pegylated (Adynovate), per IU
  • J7195 – Injection, factor VIII Fc fusion protein (recombinant), per IU, not otherwise specified (code for Eloctate)
  • J7198 – Antihemophilic factor VIII/von Willebrand factor complex (human), per factor VIII I.U. (code for Alphanate)
  • J7199 – Hemophilia clotting factor, not otherwise classified (code for Koate-DVI)

Interferons

Interferons are natural proteins with antiviral, antipro liferative, and immunomodulating effects.

CPT codes are:

  • 90277 – Injection, alpha interferon, 1 mcg
  • 90278 – Injection, alpha interferon, 3 million units
  • 90280 – Injection, beta interferon, 1 mcg
  • 90281 – Injection, gamma interferon, 1 mcg

Additional Injectable Drugs

Beyond biologics, other specialty injectable drugs also have designated CPT codes:

  • J0178 – Injection, aflibercept, 1 mg (code for Eylea)
  • J1729 – Injection, hydroxyprogesterone caproate, 1 mg (code for Makena)
  • J1817 – Injection, insulin, per 5 units (code for insulin and insulin analogues)
  • J2501 – Injection, paricalcitol, 1 mcg (code for Zemplar)
  • J3315 – Injection, triptorelin pamoate, 3.75 mg (code for Trelstar)
  • J9216 – Injection, interferon, gamma 1-b, 3 million units (code for Actimmune)
  • J9217 – Leuprolide acetate, per 1 mg (code for Lupron)

CPT Codes for Oral Specialty Drugs

While injectable biologics and specialty drugs have specific CPT codes, oral specialty medications are often billed under more general medication administration codes:

  • 96372 – Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular
  • 99201-99215 – Office or other outpatient visit codes for new or established patients, used when an oral specialty drug is administered and the provider must monitor the patient. Level of code depends on complexity of visit.
  • 96360-96361 – Hydration codes for intravenous infusion of substances for hydration, prophylaxis, or treatment, to support administration of an oral specialty cancer drug.
  • 96365-96368 – Infusion codes for intravenous infusion of substances for therapy, prophylaxis, or diagnosis, to support administration of an oral specialty cancer drug.
  • 90761-90765 – Immunization administration codes for oral vaccine administration.
  • 99241-99245 – Office consultation codes used if an oral specialty drug requires an extensive consultation between the patient and prescribing provider. Level of code is based on complexity.
  • 99341-99345 – Home visit codes that can be used if a provider must administer and monitor an oral specialty drug in a home setting. Level of code depends on complexity of visit.
  • 99347-99350 – Additional home visit codes that can be used if home administration of an oral specialty drug is especially prolonged, lasting longer than the typical service time of the base home visit code.

Billing and Reimbursement Considerations

When billing CPT codes for biologics and specialty drugs, it is important to follow coding guidelines correctly and provide detailed documentation in the medical record.

Key considerations include:

  • Select the most specific CPT code that describes the service provided. Avoid unlisted codes unless no other code applies.
  • Specify the name, dosage, and route of administration of the drug. Documentation must support the code selection.
  • Bill infusion codes separately from the medication itself, which is covered under the medical or pharmacy benefit depending on the payer.
  • For intravenous infusions, bill the initial hour code only once per encounter. Use any additional sequential or concurrent infusion codes as appropriate.
  • Codes for subcutaneous and intramuscular injections describe single injections only. Do not use them for multiple injections of the same substance.
  • Provide all relevant diagnoses, especially if required by the payer for reimbursement of the specific drug.

Since coverage and payment policies for specialty drugs vary greatly among payers, providers must verify patient eligibility, benefits, authorization requirements, and claim submission rules when using these complex CPT codes. Having an effective prior authorization process and understanding billing requirements are key to optimizing appropriate reimbursement.

Summary

The highly advanced biologics and specialty drugs used to treat complex conditions come with equally advanced CPT coding considerations. From injections and infusions to oral medications and vaccines, administering these pharmaceuticals involves selecting the CPT code that most accurately describes the service provided.

With payers increasingly focused on controlling specialty drug costs, mastering the intricacies of accurate billing and coding is critical for both providers seeking fair reimbursement and patients trying to access these life-changing therapies.

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