Oncology & Hematology Coding Alert

The arsenal of anticancer drugs grows larger with every promising clinical trial. Unfortunately, codes for new drugs are not established as quickly, leaving practices unsure of the appropriate code. It isnt always as simple as using J9999 (not otherwise classified, antineoplastic drug). Oncology practices should know the rules behind this code to avoid denials even when local medical review policies (LMRPs) say the code should be used with the new drug.

Most recently, chemotherapy drugs Herceptin (J9355), Doxil (J9001) and Epirubicin (J9180) were among those drugs that had to be coded using J9999. While they were assigned the above permanent codes in 2000, they serve as examples of how oncology practices should approach billing for commonly used unclassified drugs.

There will certainly be more new chemotherapy drugs that will have to be coded with J9999, says Nancy Giacomozzi, office manager for P.K. Administrative Services, a medical billing agency based in Lakewood, Colo., which serves several oncology practices. The following steps will guide you through the process of how to use HCPCS J9999 and ensure reimbursement:

1. Coverage: Make sure payers cover the drug. Often private insurers, especially managed-care organizations, require prior authorization before a drug is used. Medicare carriers publish their LMRPs, which indicate whether a new drug is covered and if J9999 should be used.

2. Communication: Increasing reimbursement using codes for unassigned items requires communication between the provider and payer prior to the performance of any new procedure or use of new drugs or medical supplies.

3. Written explanation: Send the insurer a letter explaining that the physicians office will be using a drug that is now without a CPT or HCPCS code. Along with the letter, the provider should send current literature describing the efficacy of the drug in similar situations.

4. Documentation: The code, however, must be supported by proper documentation, says Cathy Klein, LPN, CPC, senior consultant with Health Care Economics in Indianapolis. Although documentation is a standard requirement in all coding matters, it is especially important when coding for an unclassified drug. Medicare wants to guard against blanket use of J9999 to garner payment for drugs that are not covered or medically appropriate.

Herceptin, for example, requires the following:

documentation in the medical record must contain a history and physical pertinent to the indications of this policy;

documentation must support the medical necessity and frequency for administration of this agent; and

when a portion of the drug is discarded, the medical record must clearly document the amount administered and wasted.

5. Medical necessity: When billing for an unclassified code, the ICD-9 code that precisely describes the disease must match those a Medicare carrier indicates is a covered diagnosis for a specific chemotherapy drug.

Doxil, for example, is for use for malignant neoplasms of the breast (174.0-175.9), ovaries or other uterine adnexa (183.0-183.9), and AIDS-related Kaposis sarcoma (176.0-176.9).

The use of these codes does not guarantee reimburse- ment, Klein says. In addition to using the proper diagnosis code, documentation should include manufacturers instructions for use of the new drug, or other written practice standards. The patients medical record must support that FDA requirements have been met, she adds.

Experimental Drugs

There is a difference between drugs that Medicare assigns the J9999 code and chemotherapy drugs that are considered experimental. If an insurer has classified a drug or procedure as experimental, the chances of being reimbursed are slim, explains Klein. Instead, providers should focus on using codes for unassigned items in cases when the drug is characterized as new, and is backed by either a litany of literature that provides evidence of efficacy or has been recently approved by the U.S. FDA.

According to 45-16 of the Coverage Issue Manual (CIM), some drugs and biologicals that are distributed by the National Cancer Institutes Division of Cancer Treatment are covered, although unclassified.

Specifically, drugs designated as Group C drugs, are not limited to use in clinical trials for the purpose of testing efficacy within a tumor type and can be safely administered.

There are, however, guidelines to follow for a physician to be reimbursed using Group C drugs.
They are as follows:

A physician must be registered with the NCI as an investigator, having completed an FD-Form 1573;

A written request for the drug must be submitted to the NCI, indicating the disease to be treated;

Use of the drug must be limited to indications outlined in NCI guidelines; and

All adverse reactions must be reported to the Investigational Drug Branch of the Division of Cancer Treatment.

The CIM advises intermediaries that they may assume the uses of Group C drugs are covered as long as the above requirements are met.