Oncology & Hematology Coding Alert

There are times when most oncology practices come across a treatment, drug or supply item that is so new it has not yet been assigned a code. In such cases, the pro-viders should use a code that best resembles the procedure or use codes for unlisted procedures, drugs and supplies.

The disadvantage of the first route is that it can produce payment that is not adequate for the time and resources used during the procedure, or for the cost of the drugs or supplies used. On the other hand, using a code for unlisted items opens the door to denials and increased paperwork, not to mention audits and repayments later.

The emphasis on using existing codes for unclassified items is stressed by coding manuals as well. HCPCS, for example, instructs providers that the unclassified codes such as J9999 should be used only if a more specific code is unavailable. Used prudently, however, codes for unassigned items and procedures, such as CPT 96549 (unlisted chemotherapy procedure) and HCPCS J9999 (unclassified, antineoplastic drug), can yield payment that best reflects the resources used.

You want to supply an exact CPT code, says Daniel L. Johnson, director with Health Care Consultants of America, an Augusta, GA-based coding consulting firm, whose clients include oncology practices. Even though there are 9,000 CPT codes, you cant always find one that fits exactly. And even though payment may be difficult to get when you use unassigned codes, there are times when you have to.

Codes for Unclassified Oncology Drugs J9999 - not otherwise classified chemotherapy drugs administered by other than oral route J8999 - not otherwise classified chemotherapy drugs administered orally J3490 - not otherwise classified supportive drugs administered by other than oral route Q0181 - not otherwise classified oral anti-emetics J8499 - not otherwise classified nonchemotherapeutic drugs J7599 - not otherwise classified immunosuppressive drugs

Unassigned Codes Determined by Route
of Administration

Until a new chemotherapy drug is given a specific
J-code, its given a not otherwise classified code according to the route of administration:

1. Unclassified chemotherapy drugs, such as Herceptin, administered by other than oral means (intravenous, intramuscular, subcutaneous) are coded as J9999.

2. Unclassified oral chemotherapy drugs, such as Xeloda, are coded as J8999.

3. Unclassified supportive drugs, such as anti-emetic medications, are classified by route of administration.

Three Tasks Crucial to Getting Paid

When oncology practices must choose a code for an unassigned procedure or medical item, Johnson says, they often neglect to perform three tasks to ensure proper payment:

1. Get prior clarification from the insurer. Maximizing reimbursement with codes for unassigned items requires communication between the provider and payer prior to any new procedure or use of new drugs or supplies, says Johnson.

Get an understanding from the carrier before the procedure is done, he says. A written explanation should be sent to the insurer explaining that the physicians office will be performing a procedure or using a drug that is now without a CPT or HCPCS code. Along with the letter, Johnson says, the provider should send current literature that describes the efficacy of the drug in similar situations.

2. Document medical necessity. Documenting medical necessity is an important component in garnering proper payment. Including documentation requesting prior clarification from the insurer as part of your submission will go a long way to getting pre-approval to use an unclassified code.

None of these catch-all codes (such as J9999) refers to a quantity or dosage, unlike the codes for specific drugs (such as code J9100, cytarabine, 100 mg; or J9110, cytarabine, 500 mg). Thus the claim must include a narrative specifying the medical necessity for each of the drugs used and the quantity of each. Additional supporting documentation should include a minimum of two journal articles supporting the use of the drug in the quantity used for the particular indication. Many pharmaceutical manufacturers have reimbursement assistance programs that can aid you in this process. Contact information for these manufacturers can be found on the Association of Community Cancer Centers Website: www.assoc-cancer-ctrs.org/.

Since some drugs have been tested effective for limited types of situations, make sure that the diagnosis code supports the use of the situation for which the drug is considered effective. For example, Herceptin is approved only for breast cancer and must have diagnosis codes such as V10.3 (personal history of malignant neoplasm, breast) or 174.0-174.9 (malignant neoplasm of female breast). (See article on off-label use of drugs in box on page 5.)

Note: Its important to remember that information supplied by pharmaceutical manufacturers may reflect a vested interest and, therefore, may not be viewed as objectively as information from other sources.

Finally, correspondence with the insurer should include the actual invoice for the drug or item used. If it is a procedure that is in question, the physicians office should include the list of supplies to be used to help the insurer or fiscal intermediary determine cost.

Investing extra work up front in documenting the medical necessity for new drugs and procedures can save time in the long run, according to Kim Ransier, RN, senior consultant, KR Johnson & Associates, a full-service practice management and billing consulting firm specializing in oncology, in Coeur dAlene, ID. If we know its a new drug or treatment and theres no code and the office hasnt billed for it before, we often suggest sending a paper claim with the appropriate documentation the first few times it is billed.

Heres why: If you send a claim electronically, reimbursement takes about a week. A paper claim can take up to 30 days. So most billers will say that it makes more sense to send it electronically. But if you send it electronically, you cant attach the appropriate articles, so the claim may be denied and sent back. Then it usually sits on someones desk for a while before she or he has time to research the claim and refile it properly. So it actually can take longer by the time you walk the claim through the process after the fact than if you just sent a paper claim initially.

3. Follow up on the paid claim. Making a prior arrangement with the insurer will spare the practice from providing documentation of medical necessity when the bill is submitted. All that is left is for the practice to follow up on the claim to be sure it is actually paid, and in full. But the practices hardly ever follow up, laments Johnson.

Once payment is received, billing managers should compare the payment to the total cost as evidenced by invoices and resources used to deliver the service, he advises. Too often, practices just submit the claim and forget about it, Johnson says.

Off-label Use of Unclassified Cancer Drugs Over the past eight years, the development of new cancer drugs has outpaced the HCPCS coding system, especially chemotherapy drugs. According to the Association of Community Cancer Centers, the Food & Drug Administration (FDA) approved 43 new drugs with 49 indications for use in cancer treatment between 1992 and the second quarter of 1999. In addition, the three major drug references added 171 new indications for existing drugs. Although more and better treatment options benefit patients, the delay between drug approval and code assignment (as much as one to two years) can create headaches for coding professionals. Off-Label Use of Drugs Use of a drug for indications other than those reviewed by the FDA and referenced on the FDA-approved label is commonly called off-label use. According to the American Society for Clinical Oncology (ASCO), research shows that about half the uses of anticancer chemotherapy drugs are for unlabeled drug indications (off-label use). For example, Taxol (paclitaxel) (J9265) was initially approved by FDA for treatment of ovarian cancer (183.0-183.9) but was also used to treat breast cancer (174.0-174.9), lung cancer (162.2-162.9) and bladder cancer (188.0-188.9). Insurers, including some Medicare carriers, have denied reimbursement for chemotherapy drugs used for unlabeled indications, saying that such uses are experimental or investigational. The FDA, the National Cancer Institute, and others have criticized this practice because it denies patients the most effective therapy. ASCOs Policy Statement on Reimbursement for Cancer Care-Coverage of Unlabeled Drug Indications says: The FDA has made it clear that the drugs label is in no way intended to regulate or restrict the ability of practicing physicians to use the drug for other purposes consistent with their professional judgment. Nonetheless, insurers may deny reimbursement for off-label use unless medical necessity is clearly documented with provider narrative and at least two articles from the medical literature. Many off-label uses of anticancer drugs are for multi-drug combinations. The FDA generally grants approval for a single drug rather than combinations of drugs, so multi-drug use demands special documentation. Sometimes the combination includes a new drug with an older drug. For example, Herceptin (trastuzumab, J9999), approved in September 1998, for the treatment of metastatic breast cancer, has not been assigned a code but is widely used. In many treatment protocols, Herceptin is used with Taxol, so the claim would need to include narrative showing the medical necessity for both Herceptin and Taxol, plus two journal articles that support the use of the two-drug combination. In addition, the claim should include individual codes for any supportive drugs such as Neupogen (filgrastim [G-CSF], J1441) or Zofran (ondansetron HCl, J2405).

Experimental Drugs, Procedures Not Covered

It should be noted that the above advice does not necessarily apply to experimental drugs. If an insurer has classified a drug or procedure as experimental, the chances of being reimbursed are slim. Instead, providers should focus on using codes for unassigned items in cases where the drug is characterized as new but is backed by either journal articles that provide evidence of efficacy or has been recently approved by the Food and Drug Administration.

According to 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, this includes agents designated as Group C drugs, which means they are not limited to use in clinical trials for testing efficacy within a tumor type and they can be safely administered.

There are, however, four guidelines for a physician to be eligible to seek payment using J9999 in cases where a drug is experimental:

1. A physician must be registered with the National
Cancer Institute (NCI) as an investigator, having completed an FD-Form 1573;

2. a written request for the drug must be submitted to
the NCI, indicating the disease to be treated;

3. use of the drug must be limited to indications
outlined in NCI guidelines; and

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

In turn, the CIM advises practices that they may assume the uses of Group C drugs are covered as long as the above requirements are met.