Senate LDT Hearing Returns Focus to Legislative Fray
At a September 20 hearing of the Senate Committee on Health, Education, Labor, and Pensions, legislators made clear that Congress wants to regain control of Food and Drug Administration (FDA) action on laboratory developed tests (LDT). The hearing marked nearly a year since Congress started to weigh in on LDTs and propose that new legislation might be necessary to deal with the issue. At the hearing, Committee Chairman Lamar Alexander (R-Tennessee), knocked FDA’s proposed regulation of LDTs as “unnecessary double regulation,” but also floated the idea of creating a new, streamlined regulatory agency that would avoid overlapping CLIA, FDA, and state oversight.
At the hearing, David Klimstra, MD, chairman of the department of pathology at Memorial Sloan Kettering Cancer Center in New York, said that due to added costs his laboratory would be forced to stop performing LDTs if FDA finalizes its proposal. “The current cost of an FDA pre-market approval submission is over $260,000 … it is easy to see how a lab with dozens or hundreds of LDTs could not afford to obtain FDA approval,” he said. “This could drive innovative molecular testing out of the academic environment and into only larger commercial labs which have the resources to maintain regulatory compliance.”
However, Democrats at the hearing generally voiced support for FDA’s proposal, as did some who testified, including Jeffrey Allen, CEO of Friends of Cancer Research.
For the hearing, AACC reinforced its position that LDT oversight should remain under CLIA. In a letter to the committee, AACC advocated that CMS revise parts of CLIA to deal with the concerns raised by FDA rather than introduce costly and burdensome dual regulations for laboratories. In a position statement AACC released in February, the association recommends that CLIA be modernized to address the laboratory inspection process, quality control, proficiency testing, and the regulation of LDTs (www.aacc.org/health-and-science-policy).
Emergency Preparedness Rule Adds New Requirements
The Centers for Medicare and Medicaid Services (CMS) issued a final rule for healthcare providers that boosts requirements for emergency planning, communications, and training. The rule is meant to close gaps CMS found in existing regulations that did not adequately deal with the need for communication among health systems, contingency planning, and training.
The new rule will require some participating providers to plan for disasters and coordinate with federal, state, tribal, regional, and local emergency preparedness systems. CMS resources are available from www.cms.gov under Survey and Certification - Emergency Preparedness.
CMS Touts Savings, Quality Gains for ACOs
According to the Centers for Medicare and Medicaid Services (CMS), 2015 was a good year for accountable care organizations (ACOs). A CMS report shows that many healthcare providers in the ACO model are improving quality while reducing costs, collectively generating more than $1.29 billion in savings for Medicare since 2012.
In 2015, ACOs had combined savings of $466 million. CMS data show that more ACOs achieved savings in 2015 compared to 2014, and that those with more experience tended to perform better over time.
However, not all ACOs have reached expectations. ACOs must meet both quality and savings goals in order to benefit financially from what they save Medicare compared to benchmarks. However, CMS reported that just 125 of 470 ACOs created since passage of the Affordable Care Act hit combined minimum quality and cost savings targets in order to qualify for shared savings payments.