Name of the Procedure:

Documentation of Negative or Managed Positive TB Screen Before Biologic Immune Response Modifier Therapy (G9359)

Summary

This procedure involves documenting either a negative tuberculosis (TB) screen or a managed positive screen with additional evidence confirming that TB is not active before beginning treatment with a biologic immune response modifier. Biologic immune response modifiers are medications that can weaken the immune system, making it crucial to ensure that TB is not active before starting therapy.

Purpose

The purpose of this procedure is to ensure patient safety by confirming that tuberculosis is not active before initiating treatment with biologic drugs, which can suppress the immune system. This helps prevent the flare-up of latent TB and avoids complications associated with active TB infection.

Indications

• Patients who are candidates for biologic immune response modifier therapy.
• Individuals with a history of TB or a positive TB skin test.
• Patients experiencing symptoms consistent with TB, such as chronic cough, weight loss, night sweats, or fever.

Preparation

• Patients may need to undergo a TB skin test (Mantoux test) or a TB blood test (IGRA).
• If there is a history of TB or a positive TB screen, additional testing such as a chest X-ray or sputum culture may be required.
• There are no specific dietary restrictions or fasting requirements for the TB tests.

Procedure Description

1. Initial Screening:
   • A TB skin test or a blood test is conducted initially to screen for tuberculosis exposure.
2. Further Testing (if required):
   • For managed positive screens, further diagnostics such as a chest X-ray or sputum culture are performed to determine if TB is active.
3. Documentation:
   • All test results are documented, confirming the absence of active TB.
4. Review and Confirmation:
   • A healthcare provider reviews the documentation to ensure all necessary evidence is collected before approving the initiation of biologic therapy.

Duration

• The initial TB skin test requires a follow-up visit 48–72 hours after placement to read the results. TB blood tests are generally processed within a few days.
• Additional diagnostics could take several days to weeks depending on procedures like chest X-rays or sputum cultures.

Setting

• Screening tests are typically performed in outpatient clinics, primary care offices, or specialized medical facilities.
• Further diagnostic tests, if necessary, may be conducted in hospitals or diagnostic imaging centers.

Personnel

• Primary care physicians, nurses, and laboratory technicians.
• Radiologists and pulmonologists may be involved if further testing is required.

Risks and Complications

• Common: Minor skin irritation or allergic reaction at the TB skin test site.
• Rare: False-positive or false-negative test results necessitating further testing.

Benefits

• Assures the safe initiation of biologic immune response modifiers.
• Prevents reactivation of latent TB or exacerbation of active TB.
• Protects patient health and enhances treatment outcomes.

Recovery

• No recovery time is required after TB screening tests.
• Follow-up appointments may be necessary to discuss results and next steps.

Alternatives

• Regular monitoring and deferment of biologic therapy until more definitive TB status is established.
• Alternative, non-biologic medications that do not suppress the immune system to the same extent.

Patient Experience

• Mild discomfort may be experienced during the TB skin test from the needle prick.
• Anxiety related to waiting for test results, especially with a history of TB.
• Clear communication with healthcare providers regarding test results and safety is crucial to managing any concerns.