FOLOTYN® (pralatrexate injection) Coding Information – HOSPITAL OUTPATIENT
The following coding information is commonly used for FOLOTYN, when used for the treatment of its FDA-approved indication for relapsed or refractory peripheral T-cell lymphoma, including the drug’s administration.
It is important to note that each payer may have different coding requirements for FOLOTYN, and that actual coding decisions are the responsibility of the provider based on the patient’s specific situation. The ASAP program may assist you in verifying coding requirements for specific payers, and the state-by-state map below contains guidance for specific payers (if available).
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*Note that the product’s FDA standard NDC code has been “zero-filled” to ensure creation of an 11-digit code that meets HIPAA standards. The zero-fill location is indicated in bold. Food and Drug Administration.11
*Some payers require 202.80-202.88 for certain PTCL subhistologies without otherwise specified ICD-9 codes. Please verify coding requirements on a patient-specific basis.
- Sample CMS-1450 for Outpatient Hospital - 2011 dates of service
- State-by-State Coverage, Coding, and Payment Map - At a Glance
- Click here to download “J9307 Flashcard”
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1 Medicare Claims Processing Manual: Chapter 17 - Drugs and Biologicals. Section 70 - Claims Processing Requirements – General.
2 Centers for Medicare and Medicaid Services. Healthcare Common Procedure Coding System. Accessed at: http://www.cms.gov/HCPCSReleaseCodeSets/ANHCPCS/list.asp#TopOfPage
3 U.S. Food and Drug Administration. National Drug Code Directory. Accessed at: http://www.fda.gov/Drugs/InformationOnDrugs/ucm142438.htm
4 American Medical Association. 2011 Current Procedural Terminology.
5 International Classification of Diseases, Ninth Revision, Clinical Modification – Sixth Edition.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- FOLOTYN may suppress bone marrow function, manifested by thrombocytopenia, neutropenia, and anemia. Monitor blood counts and omit or modify dose for hematologic toxicities.
- Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or modify dose. Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.
- Fatal dermatologic reactions may occur. Dermatologic reactions may be progressive and increase in severity with further treatment. Patients with dermatologic reactions should be monitored closely, and if severe, FOLOTYN should be withheld or discontinued.
- Tumor lysis syndrome may occur. Monitor patients and treat if needed
- FOLOTYN can cause fetal harm. Women should avoid becoming pregnant while being treated with FOLOTYN and pregnant women should be informed of the potential harm to the fetus.
- Use caution and monitor patients when administering FOLOTYN to patients with moderate to severe renal function impairment.
- Elevated liver function test abnormalities may occur and require monitoring. If liver function test abnormalities are ≥Grade 3, omit or modify dose.
Adverse Reactions
- The most common adverse reactions were mucositis (70%), thrombocytopenia (41%), nausea (40%), and fatigue (36%). The most common serious adverse events are pyrexia, mucositis, sepsis, febrile neutropenia, dehydration, dyspnea, and thrombocytopenia.
Use in Specific Patient Population
- Nursing mothers should be advised to discontinue nursing or the drug, taking into consideration the importance of the drug to the mother.
Drug Interactions
- Co-administration of drugs subject to renal clearance (e.g., probenecid, NSAIDs, and trimethoprim/sulfamethoxazole) may result in delayed renal clearance.
