By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence
Government agencies that impact the laboratory industry have submitted budgets for fiscal year 2016 that will fund efforts to reduce healthcare spending, focus on quality of care rather than quantity, pursue fraud and other compliance violations and promote innovation. The FDA’s $4.9 billion requested budget targets precision medicine, seeking funding that will help the agency promote “the development and appropriate use of reliable molecular and genetic diagnostics—precision medicine tools—to ‘personalize’ the diagnosis, treatment, and prevention of disease.” The agency expressed a need to add more scientists and clinicians to assist with premarket review of these new technologies, and indicated the requested funding will also support development of standards for next generation sequencing.
Among the other items highlighted in the FDA’s budget overview are food safety, medical product safety and medical countermeasures relating to “chemical, biological, radiological, nuclear and emerging infectious disease threats.” The FDA also included a sizable budget request devoted to addressing antibiotic resistance, including support for development of new tests that can rapidly detect and help respond to antibiotic resistant bacteria. The budget doesn’t directly mention any plans with regard to regulation of laboratory developed tests other than to explain its 2014 accomplishments with regard to issuing a proposed framework for such regulation.
The OIG also requested $417 million to fund its continuing efforts to combat fraud, abuse and waste, including its joint efforts with the Department of Justice and the Health Care Fraud Prevention and Enforcement Action Team (HEAT). Funding will support continued focus on recovering improper payments, ensuring quality care and providing more compliance guidance and other educational efforts to help providers improve compliance. For more information on the FDA’s and OIG’s budget requests, see the next issue of National Intelligence Report.