HCFA pilot study uncovers problems in PPM and waived labs.Two Health Care Financing Administration Health Care Financing Administration, n.pr department in the U.S. agency of Health and Human Services responsible for the oversight of the Medicaid and Medicare benefit programs, including guidelines, payment, and coverage policies. pilot studies in Ohio and Colorado have found some troubling quality and payment problems among labs doing waived and provider-performed microscopy (PPM) testing under the Clinical Laboratory Improvement Amendments Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. of 1988. This issue is important to lab operators because it raises questions about the waived testing program. Many of the labs surveyed were not in compliance with CLIA CLIA Clinical Laboratory Improvement Amendments of 1988 Congressional legislation that promulgated quality assurance practices in clinical labs, and required them to measure performance at each step of the testing process from the beginning to the end-point of a , Inaccurate results, failure to follow manufacturers' instructions when performing the tests, and doing tests outside the lab's CLIA certificate were among the problems discovered. The type of tests done beyond the scope of the surveyed labs' certificates were both moderate and high complexity. To determine if these problems exist on a larger scale, HCFA HCFA abbr. Health Care Financing Administration HCFA, n.pr See Health Care Financing Administration. plans to expand its study to one state per regional office, according to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. Judith Yost, who oversees the CLIA program for the agency. It is not clear at this point exactly what HCFA will do to deal with noncompliance noncompliance failure of the owner to follow instructions, particularly in administering medication as prescribed; a cause of a less than expected response to treatment. noncompliance . After the agency completes the expanded pilot, it intends to evaluate the findings and then determine what steps it will take, says Yost. Currently, HCFA directly surveys only 26,000 labs, and this number may drop further if additional states receive CLIA-exempt status. Washington and New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of are currently the only CLIA-exempt states. If more states join them, additional surveyors may be available to do more random checks on unregulated labs. Another possible problem that may have to be addressed deals with Medicare reimbursement to these labs for performing moderate and high complexity tests. "If Medicare is reimbursing these labs for those tests, the reimbursements represent unauthorized payments because the government is only authorized to make payments to labs that have an appropriate certificate," says Mark Birenhaum, PhD, administrator for the American Association American Association refers to one of the following professional baseball leagues:
HCFA estimates that 52% of all labs perform only waived tests. Another 22% are limited to performing waived and/or microscopy tests. These labs are subject to HCFA inspection to determine if they are performing the testing that they are certified to do. A public workshop at the Food and Drug Administration was held in August to discuss the criteria and process the agency uses to categorize a test as waived under CLIA. Watch this space for an update. |
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