Professional Billing (Sample CMS – 1500 Claim Form)

Physician Office Billing Guide: Product Information

Each payer/plan with which you participate may have different coding and documentation requirements for claim submissions.

All coding and documentation requirements should be confirmed with the respective payer.

Click here to download "Sample CMS-1500".

Helpful Steps for Establishing and Confirming Product Reimbursement:

• Request a copy of published product coverage, or informal coverage and coding requirements from payers
• Support reimbursement processes with submission of the following to payers, as needed:
  • Letter of Medical Necessity
  • Supply payers with the FDA approval letter and/or product insert prior to treating a patient. Full prescribing information is available at www.allos.com under the “prescribing information” option.
• Request support from your state’s hematology or oncology Contractor Advisory Committee (CAC) Representative
• Contact the Allos Therapeutics ASAP Program at 1‐877‐ASAP102 (272‐7102) for reimbursement information

FOLOTYN^TM is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.

The indication for FOLOTYN is based on overall response rate. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated.

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 (see Dosage and Administration, section 2.5).

Mucositis may occur. If ≥Grade 2 mucositis is observed, omit or modify dose (see Dosage and Administration, section 2.5).

Patients should be instructed to take folic acid and receive vitamin B12 to potentially reduce treatment-related hematological toxicity and mucositis.

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 (see Dosage and Administration, section 2.5).

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.

¹ Reference product full prescribing information regarding dose modifications based on adverse events.