January 27, 2003

Dear Fellow Allergists:

We are writing to make you aware of two recent activities by the Office of Inspector General of HHS that could affect you. The OIG is the arm of HHS which is responsible for identifying fraud and waste in the Medicare program generally, and for investigating individual physicians for potential fraud and abuse.

Compliance with Medicare Billing Rules for Allergy Immunotherapy

In November of 2002, the OIG released a report of a study it conducted on compliance with Medicare rules for billing for allergy immunotherapy under CPT Code 95165. The OIG found that only 44% of physicians billing for allergy immunotherapy were correctly following Medicare billing rules. Those new rules, which JCAAI members were notified of in 2001, define a "dose" (for billing purposes only - not for treatment purposes) as one cc of allergy extract in a multi-dose vial. In addition, the new rules provide that Medicare will not cover dilutions and therefore, allergists should not bill for them. For more information on Medicare billing rules for immunotherapy please visit the JCAAI website.

Although we are not aware that this issue is a priority for the OIG, it is now on the OIG's radar screen and, given the low compliance rate found in the study, the OIG may start targeting this area for review. The OIG has the right to request copies of all records relating to Medicare, Medicaid and federal health programs to determine whether you are complying with the new rules. Physicians who are found to be out of compliance could be at risk for a variety of penalties including fines and even exclusion from the Medicare program. Exclusion from Medicare could result in a physician being unable to practice medicine at all.

If you are not sure whether you are in compliance with the new rules, we urge you to review your billing practices and make sure you are complying.

The second issue the OIG is looking at is documentation of the medical necessity of allergy immunotherapy. The OIG, in conducting the billing study discussed above, discovered several instances in which physicians (it is not clear whether they were allergists) were providing immunotherapy in situations in which it may not have been medically necessary or was contraindicated. Of particular concern was the length of immunotherapy, the administration of low-dose immunotherapy and immunotherapy for patients on beta-blockers.

As a result of its findings, the OIG is doing a more comprehensive study of allergy immunotherapy focusing, in particular, on the above issues. We are informed that they are requesting records from physicians around the country. If your records are requested and they related to a Medicare or Medicaid or other federal health program, you must comply with the request.

In addition, even if you are not asked to participate in the OIG study, it is important that medical necessity of immunotherapy be clearly documented in your records. We strongly urge you to familiarize yourself with the new immunotherapy practice parameters developed jointly by the ACAAI, AAAAI and JCAAI which have just been finalized . They are published in the January 2003 issue of the Annals of Allergy and will be on the JCAAI website, soon - check after February 1, 2003.

The practice parameters are designed to assist clinicians by providing a framework for the evaluation and treatment of patients and are not intended to replace a clinician's judgment or establish a protocol for all patients. Not all recommendations will be appropriate for all patients. However, we believe that Medicare may use the practice parameters as a benchmark for medical necessity reviews. Therefore, where you decide it is appropriate to deviate from the practice parameters because of an individual patient's treatment needs, we recommend that you consider your decision in light of the relevant practice parameter and document in the chart your reason for this decision, to the extent appropriate. For example, if you determine that immunotherapy should continue beyond 5 years, it would be prudent to reflect in the patient chart the reason for continuation since it is a deviation from the practice parameters.

We believe it is likely that allergy immunotherapy will be subject to heightened scrutiny in the future and that our members may see more audits of their patients by Medicare. We are concerned that each and every physician continue to have the unfettered ability to practice medicine. In order to survive a medical necessity audit of your records, it is critical that the medical necessity for immunotherapy be documented especially where your clinical judgment requires that you deviate from the practice parameters. Failure to document can result in recoupment by the government, fines and penalties, and may even be a basis for a false claims prosecution.

In summary, we urge that you:

• Review your billing practices to ensure you are complying with Medicare billing rules
• Become familiar with the new immunotherapy practice parameters and document medical necessity especially where you deviate from the parameters.

Sincerely,

Lanny Rosenwasser, MD
President-Elect

William Berger, MD
President, ACAAI

J. Spencer Atwater, Jr., MD
President, JCAAI