June 2, 2004

Sandra Shrewy, Director
California Department of Health Services
1501 Capitol Ave., Ste. 601
Sacramento, CA 95814

Dear Director Shrewy:

I am writing on behalf of the California Urologic Association about the potential impact upon urologists and their office laboratories if State oversight and fees are assessed in addition to those currently assessed by the Federal Clinical Laboratory Improvement Act (CLIA) program. Although you have already spoken with representatives from the California Medical Association on this topic, we feel it is very important that you appreciate the special impact this proposal would have on our specialty and our patients. The California Urologic Association was founded in 1986 to address issues of quality of care, access to care and to protect the urological care for the people of California. It is dedicated to addressing many of the complex healthcare issues debated in Sacramento today.

The practice of urology demands that practitioners have the ability to evaluate urine specimens to determine the cause and treatment of patients complaining of diseases of the urinary tract. This involves microscopic urinalysis (which is considered a physician performed microscopy procedure) as well as urine culture and sensitivity testing (which is considered by CLIA as a highly complex test). Although some labs perform more than these studies, these are the minimum needed by a urology physician to evaluate patient complaints. The highly complex category assigned to urine culture and sensitivity testing requires that urology labs pay the highest fees applicable and adhere to the most stringent quality standards. We are proud to be capable of providing this service to our patients. Moreover, we are able to provide cost effective and timely care by rapidly determining abnormal urine findings days earlier than available through a reference lab at a fraction of the cost. This allows us to rapidly and efficiently begin patients on treatment that minimizes discomfort, lessens the duration and impact of disease and often cures patients before they are too sick for outpatient therapy. Taking away our ability to evaluate this integral part of a patient's urologic exam is no different than asking an ophthalmologist to treat without examining the eye or a cardiologist to prescribe without taking a blood pressure or listening to the heart. And yet the excessive fees and oversight proposed would stop most urologists from providing this service reducing access to laboratory studies and medical care.

We are extremely concerned that the highest quality of care be maintained. We believe the current single level of fees paid to CLIA and periodic evaluation of physician office labs performed to meet federal standards is sufficient to guarantee that proper standards are being met. There would be no additional benefit from dual fees and dual oversight from the state in addition to the federal program. Such duplication would be onerous and cost prohibitive for the vast majority of urology office laboratories. At the present, the mandated quality assurance and record keeping necessary to support a highly complex lab causes most urology offices to lose money on every lab study performed. Our doctors feel they must continue this service in order to provide proper care

for their patients. However, there is a limit to how far physicians will go as costs continue to soar and reimbursement levels continue to fall. One needs only to consider the proposed significant increase in state fees for a high complexity lab (applicable to most urology offices) to understand the increased and onerous burden dual licensing will place. The additional fees and regulations proposed would be ruinous for most private urology offices causing them to finally cease offering lab studies to their patients. Since most patients lack the time, ability or mobility (many of our patients are elderly and frail) to take their specimens to a nearby lab, patient compliance with ordered tests would become a nightmare. This will lead to a dramatic drop in the quality of care provided when a patient with fever and voiding symptoms or pain and blood in the urine cannot be started on therapy because a reference lab is not available and cannot return results for many days during which time the patient becomes progressively more ill. If we are asked to treat blindly without urine examination to guide us, mistakes will be made and treatment delayed.
This runs contrary to all of our interests. And yet, if fees, oversight and regulations are duplicated making an already financially non-viable situation worse, urologists will have no choice but to discontinue to serve their patients' laboratory needs.

We cannot support adding State oversight and imposing additional fees that do nothing to improve the quality of care to our patients. This proposal amounts to a duplicative tax on physicians to support other, unrelated aspects of the Laboratory Field Services Division. While we are very sympathetic to the budget deficit, we do not feel it is proper to correct this on the backs of urology office laboratories.

Please help us to maintain access to laboratory services for our patients.

Please do not increase the operating loss for urologists providing lab services that are so necessary to our practice.
Please do not duplicate the fees, regulation and oversight already in place from the Federal government. Please retain the existing regulations that exempt physician office labs from state regulation and do nothing to further implement SB 113 until a permanent legislative correction to the problem is obtained. On behalf of all of California's urologists, please continue to work with us and the California Medical Association to address this issue and to assure ongoing access to care for our patients.

Yours truly,

Jeffrey Kaufman M.D., F.A.C.S.
Past President
California Urologic Association