POLICY NUMBER: OTH-9518

DESCRIPTION: Theophylline is mainly used as a bronchodilator, and is a commonly prescribed agent for treatment of acute and chronic symptoms in asthma and chronic obstructive lung disease. It is also used clinically as a diaphragmatic stimulant in intubated patients, in nonreversible chronic obstructive airway disease. Long recognized as an effective agent for reversal of bronchospasm, Theophylline may also produce serious, potentially life threatening toxicity.

POLICY TYPE: Local Medical Necessity Policy

HCPCS SECTION BENEFIT CATEGORY: Pathology and Laboratory

HCPCS CODES: 80198 Therapeutic Drug Assay - Theophylline

HCFA'S NATIONAL POLICY: None

INDICATIONS AND LIMITATIONS OF COVERAGE: Therapeutic drug monitoring of Theophylline is indicated if:

1. The drug is being initiated or dosage has been changed

2. There is absence of therapeutic response

3. Toxic symptoms occur

4. There is a suspected drug interaction

5. Determined at 6 - 12 month intervals in a steady state situation.

Theophylline has a narrow therapeutic index. Clinical signs of toxicity include tachycardia (in the absence of hypoxia or fever), anorexia, nausea, occasional vomiting, diarrhea, insomnia, irritability, restlessness, and headache. Symptoms indicating severe theophylline toxicity are agitated maniacal behavior, frequent vomiting, extreme thirst, slight fever, tinnitus, palpitations, and arrhythmias.

Some drug interactions which may have clinical significance include Cimetidine, high dose Allopurinol, oral contraceptives, Propranolol, Ciprofloxacin, Erythromycin, Rimatidine, Rifampin, Nicotine, Xanthines, Phenytoin, Ephedrine, Barbiturates, Carbamazepine Furosemide and Verapamil.

The serum concentration may be rechecked at appropriate intervals, such as within 3 days of a dosage adjustment, or every 6-12 months in a steady state situation.

Dosage must be individualized according to serum levels and clinical response. Regular monitoring of the patient's clinical state and serum theophylline level is necessary.

Medicare does not cover routine screening in the absence of signs or symptoms. Periodic monitoring of serum levels of high risk medication such as Theophylline is not considered screening.

Monitoring Theophylline levels in a steady state situation is not medically indicated more frequently than every 6-12 months.

COVERED ICD-9 CODES:

466.0 - 466.1 Acute bronchitis

491.20 - 491.21 Obstructive chronic bronchitis

493.0 - 493.91 Asthma

496 Chronic obstructive lung disease

519.1 Bronchospasm

V67.51 Follow up exam for patient on Theophylline

Note: Diagnostic codes are to be used at their highest level of specificity. Fourth and fifth digits should be utilized when they are available.

EMC and hard copy claims will be monitored for appropriateness and frequency.

REASONS FOR NONCOVERAGE: Medicare does not provide coverage for tests obtained for screening purposes or for tests obtained for medically unnecessary indications.

NONCOVERED ICD-9 CODE(S): N/A

SOURCES OF INFORMATION:

1. Jacobs, D.S. and Tilzer, L.L., Laboratory Test Handbook, 3rd Edition, 1994, pg. 1002.

2. Lacy, C., Armstrong, L.L., Ingrim, N. and Lance, L.L., Drug Information Handbook, 3rd Edition, 1995-96, pg. 1072-1079.

3. Other Carriers' Policies.

CODING GUIDELINES: The ICD-9-CM diagnosis code and CPT code must be linked on the claim form.

Place of Service: Office (11)

Independent Laboratory (81)

DOCUMENTATION REQUIREMENTS: Documentation in the medical record must indicate testing is being done either for the presence of abnormal signs, or symptoms suggesting toxicity or for established disease requiring Theophylline treatment.

Payments can be made on a REVIEW basis for diagnosis other than those listed above.
The utility and need for these services must be documented to be:

1. Safe and effective.

2. Appropriate for the diagnosis.

3. Not for convenience.

4. A need not met by another service already performed.

Documentation should include but is not limited to:

1. Peer reviewed medical literature.

2. AMA DATTA reports.

3. Policy of specialty groups.

4. Office notes, lab reports.

OTHER COMMENTS: This policy will be utilized in conducting postpayment reviews.

Nonphysician Claims (i.e., independent clinical labs) - Documentation supporting the medical necessity of this item such as ICD-9 codes, must be submitted with each claim, Claims submitted without such evidence will be denied as being not medically necessary.

RATIONALE FOR CREATING POLICY: Comprehensive medical reviews revealed significant overutilization of this lab procedure.

CAC NOTES: This policy was discussed at the 9/26/95 CAC meeting.

There were no comments received during comment period (09/26/95 - 11/10/95).

START DATE OF COMMENT PERIOD: 09/26/95

START DATE OF NOTICE PERIOD: 09/26/95

EFFECTIVE DATE: 01/10/96

REVISION DATE:

REVISION NUMBER:

This policy does not reflect the sole opinion of the carrier or Carrier Medical Director. Although the final decision rests with the carrier, this policy was developed in cooperation with the Carriers Advisory Committee, which includes representatives from:

Medical Specialty Societies

Mississippi State Medical Association

Mississippi Foundation for Medical Care

Additional Distribution: Medical Directors in Region IV

Published in Medicare News