NCASM Legislative Update 3/15/2008

Federal Issues:

IVDMIA Update – Currently the draft guidance documents are still pending implementation. This guidance is still under review. This guidance represents a substantial departure from the long – established FDA policy of letting clinical laboratories that offer user-developed (home brew) assays be regulated under existing CLIA guidelines. This guidance seeks to apply the medical device laws to tests developed in the clinical lab arena and to require laboratories that perform user-developed assays to apply for FDA approval for these assays. Numerous clinical lab professional societies including ASM, ASCP, ALCA & AACC have filed position statements outlining their concerns that the broad definition of these assays in the draft reports could potentially encompass a number of established tests and may be too subjective to enable labs themselves to determine if their test is included in this classification. There is also concern that if FDA approval for user-developed assays becomes a requirement, the cumbersome nature of the FDA approval process would hinder the development of these assays and prevent smaller labs from participating in the development process and bringing much needed assays that address local needs to their patients.

Medicare Competitive Bidding Project – This project is a 3 year study that has resulted from a Congressional mandate (via the Medicare Modernization Act of 2003). The aim of this study is to determine whether competitive bidding could be used to provide quality Medicare Part B clinical lab services at reduced cost to the Medicare system. This project effects outpatient testing only, and labs that provide for greater than $100,000 services. Just a little background to provide perspective to this issue: Laboratory services account for less than 2% of medicare spending but influence an estimated 60 to 70% of medical decisions. As a result of caps implemented since the mid –1980s, lab payments have decreased by about 50% (in real, inflation-adjusted dollars) between 1984 and 2006. The study site was announced last October, and it encompasses the San Diego –San Marcos & Carlsbad area in SoCal. Bids from qualifying labs were due mid-February, with the administration calling for the program to be expanded and made permanent before any results from the study are known. ASM in addition to a large group of professional societies have filed position statements outlining their concerns that the competitive bidding program will sacrifice patient quality as well as access to care in order to award contracts to the lowest bidder.

What is being done to speak up about this? Three labs in the area filed a lawsuit in Federal court to obtain a restraining order halting bid submission, but the court denied this motion. Two bills have been introduced in Congress to reject the study. These bills have been introduced and referred to subcommittee. Senators Feinstein & Boxer are co-sponsors of the Senate version, and there are no SF Bay area congress members that are onboard with the House version (H.R. 3453). If you feel strongly about this issue, please contact your member of Congress.

State Issues:

The most recent CLTAC meeting was held 3/7/2008. There were updates on the progress of several state bills. Two of these bills concerned microbiology issues.

SB 1184 would require the reporting of ALL CD4 test results to a local health officer (including CD4 cell count as well as patient name). This reporting allows the state to comply with a CDC reporting requirement for the Ryan White Fund. This program funds last resort care for patients with HIV/AIDS. This bill is set for a hearing on 3/26/2008.

SB 1058 is the "Medical Facility Infection Control & Prevention Act" which implements procedures for health and residential care facilities surrounding MRSA issues of screening, reporting and decreasing MRSA and other multiply drug-resistant organisms. This bill makes severe cases of MRSA (defined as cases where a previously healthy person dies or is admitted to ICU) reportable to the local health department. The sister professional society CAMLT is opposed to this bill because it delegates new reporting requirements and does not address the duplicate reporting that will arise. This bill was implemented 2/14/2008.

Upcoming issues in the State Legislature:

DPH 08-01 regards the amendment & revision of 17 CCR 1030 –1061. This revision is necessary to update clinical lab personnel issues arising from recent developments with the state licensure exam. LFS has recently approved the use of national certifying exams for most personnel licenses. LFS has completed the revisions and the proposal will soon be released for public comment.

DPH 08-02 concerns the revision of 17 CCR 1050 (Autoverification and Lab Director issues). This revision will bring California state regulations into agreement with Federal CLIA regs. LFS staff have agreed upon the changes required, but further work on this is pending.

LFS and the 2008 CLS Licensure Exam: LFS has announced the addition of the clinical toxicologist, clinical chemist and clinical microbiologist specialist categories to the list of licensees that have had the use national certifying organization exam results approved for California licensure. Due to this, there will NOT be licensing exams offered in Nov. 2008.