CLIA '88 SIMPLIFICATION PROPOSED BY FIRST LADY
This article was originally published in The Gray Sheet
Executive SummaryCLIA '88 SIMPLIFICATION PROPOSED BY FIRST LADY Hillary Rodham Clinton at the American Medical Association House of Delegates' meeting in Chicago on June 13. "We have to simplify and eliminate the burden from regulation created" by the Clinical Laboratory Improvement Amendments of 1988, Clinton proclaimed. She called CLIA '88 "a well-intentioned law with many unexpected consequences ...that have affected not only those of you in private practice, but public health departments -- like ours in Arkansas - - around the country." CLIA is "one specific issue I want to mention, because I feel strongly about it," Clinton remarked. She called on physicians to "help us know what should be eliminated so that we then can focus in on a very small part of this whole situation -- and eliminate the rest of the regulations that were thrown in on top." The 1988 amendments to CLIA require the roughly 200,000 U.S. clinical labs to meet minimum personnel, quality control and assurance, patient test management and other standards. Implementing regulations, which have met with resistance from professional and trade organizations, could lead to the curtailment or closure of 4,000 physician office labs, according to an April 1992 study cosponsored by AMA and other health groups ("The Gray Sheet" April 27, 1992, p. 6). On June 15, the AMA House of Delegates voted to seek a repeal of the law. The amendment approved by the delegates states that AMA will "establish as primary policy the repeal of the CLIA '88." The motion was passed despite recommendations by the Board of Trustees to oppose only the most onerous portions of the law. The June 15 vote followed heated committee exchanges as to whether that stance would be politically counterproductive. "Repealing anything is difficult," maintained board member Jerald Schenken, MD, who warned members about "congressional zealots" and "horror stories" that might result in public relations problems. "Once we actively seek repeal, our ability to deal with regulators ...will be foreclosed. It's just a practical reality." However, the majority of the house ultimately disagreed. California delegate Gary Krieger, MD, urged the AMA to nullify "this gargantuan inappropriate piece of legislation which is destroying our ability to practice medicine." At its December 1992 interim meeting, the association voted not to seek repeal of the CLIA '88 unless efforts at revising the law failed ("The Gray Sheet" Dec. 14, 1992, p. 35). Rep. John Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, is expected to meet with staffers the week of June 14 to discuss the status of CLIA '88. Topics to be addressed are likely to include potential legislative or regulatory modifications to CLIA. Dingell has been critical of HHS' efforts to implement the law over the past several years ("The Gray Sheet" May 18, 1992, p. 3).
You may also be interested in...
A reagent in a batch of COVID-19 tests shipped by the US Centers for Disease Control and Prevention to state laboratories “wasn’t performing consistently,” a CDC says, so the agency is reformulating it – slowing down the labs’ ability to use the diagnostic, which yielded inconsistent results when quality-tested. But waiting in the wings are commercial coronavirus test kits being developed by Qiagen and Cepheid; both firms say they’ll submit the kits to the FDA for emergency-use approval.
OIG will focus on successful drugs that have been repurposed as orphans, noting nine of the 10 top selling drugs have both orphan and non-orphan indications.
Switzerland’s SIX exchange-listed drug development company, Basilea, is moving two new oncology candidates along its R&D pipeline, supported by strong revenues from two partnered anti-infective products.