American Association for Clinical Chemistry
Better health through laboratory medicine
05/22/98

Office of the Inspector General
Department of Health and Human Services
Room 5527, Cohen Building
330 Independence Avenue, SW
Washington, DC 20201

Dear Sir/Madam:

The American Association for Clinical Chemistry (AACC) welcomes the opportunity to comment on the March 25, 1998 proposed rule revising the Office of Inspector General’s (OIG’s) civil penalties for fraud and abuse. We share your desire to eliminate fraudulent and abusive billing practices. Providers intentionally abusing the health care system should be severely punished. However, because of the potential severity of the penalties, it is equally important the OIG presume the innocence of an accused entity until it is proven guilty.

Use of Statistical Analysis to Determine Fraud and Abuse

In a number of national investigations, the OIG performed audits of hospital billing practices to identify aberrant billing practices. We agree that this is an appropriate technique for discerning potential reimbursement problems. However, it is important that the agency investigate the specific allegations against a provider before taking action—especially now that the penalties may reach $10,000 per claim.

For example, one hospital recently testified before Congress that the Department of Justice (DOJ) charged them for duplicate billings, because they sought reimbursement for multiple glucose tests on a single patient on the same day. The hospital later reviewed the patient’s medical record and discovered that the patient had diabetes. Quite often, the physician must determine the level of blood sugar in the patient before prescribing the insulin dosage, as well as periodically monitor the level until the patient is stable. Thus, in this instance, multiple tests were justified. AACC urges the OIG (and DOJ) to carefully review and investigate preliminary findings before accusing a health care provider of fraud and abuse.

Inaccurate Billing Information from Medicare Contractors

Another area of concern for health care providers is contractors’ responsibility for accurate guidance on Medicare reimbursement issues. Laboratories rely on their Medicare contractors for direction on how to bill for services. However, sometimes the contractor provides unclear or inaccurate information to the laboratory, resulting in billing errors. AACC does not believe laboratories should be penalized in such situations.

We agree that a laboratory should pay back any amount it may have been overpaid due to contractor error. However, the facility should not be subject to civil penalties or assessments. We urge you to amend section 1003.16 (b)(2) Determinations regarding the amount of the penalty and assessment: Degree of culpability to include contractor error as a mitigating factor when determining whether, or how much, to penalize a health care provider.

Adequate Time to Respond to Allegations

Section 1005.7 Discovery gives health care providers 15 days to fully comply with an OIG request for documentation. We believe this timeframe is inadequate. The OIG makes no distinction between whether it is requesting information on 10 claims or 10,000 claims. Further, there is no recognition that such information may be stored at a different location. AACC recommends that the Agency extend the reporting timeframe to 30-60 days, as specified in the model hospital compliance plan.

By way of background, AACC is the principal association of professional laboratory scientists--including MDs, PhDs and medical technologists. AACC’s members develop and use chemical concepts, procedures, techniques and instrumentation in health-related investigations and work in hospitals, independent laboratories and the diagnostics industry nationwide. The AACC's objectives are to further the public interest and educational activities and to help maintain high professional standards.

If you have any questions or we may be of any assistance, please call me at (708) 216-4725 or Vince Stine, Director, Government Affairs, at (202) 835-8721.

Sincerely,

 Stephen Kahn, PhD, DABCC

President