STATE CLIA FEES

From Jeffrey Kaufman, M.D.
CUA Director of Legislative Affairs

There is an urgent need to contact Governor Arnold Schwarzenegger, the director of the Department of Health Services (Sandra Shewry at www.dhs.ca.gov or fax to 916-440-7404) and your state legislators about California's plans to double your CLIA fees. The passage of SB 113 in 1995 was intended to make California's laws governing physician office labs consistent with federal standards and to allow the state to seek federal CLIA exemption which would avoid dual regulation and oversight. However, emergency regulations delayed implementation of the law so that labs with CLIA certificates could avoid dual licenses and fees until the federal exemption was obtained. Two years ago, the DHS proposed reinstating the law and doubling fees and lab inspections. The CUA in concert with other state specialties was successful in convincing them at that time that such a move would impair patient access to care and the Davis administration dropped their plans. However, with little prior notification, the current Republican administration has decided to balance their budget on our backs and mailed a letter June 6, 2005 to "all clinical laboratories" notifying them of plans to subject all physician operated labs (POLs) to a separate state system of lab fees and regulation that is duplicative of the federal CLIA oversight system. This will cost at least $58 per year for the simplest level lab that does nothing more than waived tests or physician performed microscopy procedures (PPMP) like urinalysis and as much as an extra $1000 per year for labs that do urine culture and sensitivity testing (considered a high complexity lab under CLIA guidelines). In addition, the extra level of inspections will be very costly in time and money to comply with state investigators who are much more rigid, unforgiving and punitive than federal or COLA inspectors. These costs are entirely duplicative and add nothing to quality or patient care. They are simply an effort to raise funds for a bankrupt state government and guarantee jobs for employees of the badly managed Laboratory Field Services branch of DHS. The ultimate goal appears to force POLs out of business in favor of the larger commercial lab complexes. Obviously, this will adversely impact patient care not to mention making the practice of urology near impossible without the ability to perform our own urinalysis and urine cultures.

The CUA is working closely with CMA just as we did successfully a few years ago to reverse this decision. But we need your help. It is unlikely that the administration of the Department of Health Services will unilaterally reverse their position. However, we can make the case to the governor to force them to change by pointing out the impact this rule will have on our patients' access to care. Further, we will need to have legislation introduced to overturn this money grab. That will take pressure on your state elected representatives.

A letter, fax, email or phone call is important to make your concerns heard.
To find your areas assemblymen click here.
By clicking here, you will find a copy of the letter sent to the former DHS director who realized the impact of her proposal and deferred implementation. Please feel free to borrow heavily from that letter or put into your own words how this will impact your ability to provide for your patients. We are all concerned about delivering quality care to those in need. However, doubling fees and duplicating inspections will not serve that goal and will become counter-productive.
Get involved and speak out now!

Jeffrey Kaufman MD, FACS
Past President
CUA

If there are any further questions, please contact the CUA by email at info@cuanet.org
or by phone at 714-550-9155.