AACC and 18 other stakeholders are asking Congress not to rush into a decision on regulation of laboratory developed tests (LDTs). Congressional leaders, including Senate health committee Democratic Chair Patty Murray of Washington and ranking Republican Richard Burr of North Carolina, are considering a plan to package changes to the regulatory model for LDTs into upcoming legislation on Food and Drug Administration (FDA) user fees, called the Medical Device User Fee Agreement (MDUFA). Such a move could short-circuit debate on controversial LDT legislation.
“Legislation to reauthorize MDUFA will reflect an agreement negotiated between the FDA and the medical device industry it fully regulates, entailing policy issues and considerations that have been discussed and debated before that agreement is even transmitted to Congress,” a letter from the AACC-led stakeholder group says. “These negotiations involve different stakeholders than those relevant to the reform of the regulatory oversight of LDTs…Further, MDUFA reauthorization will proceed on an expedited basis because of both the FDA’s agreement with medical device stakeholders and the necessity to reauthorize legislation before the current agreement expires.”
AACC and other groups worry that a rush to tackle LDTs as part of MDUFA would lean on an existing bill Burr has supported, the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021. AACC’s letter called the VALID Act a “complex bill proposing dramatic modifications to current oversight mechanisms and thus has the potential to significantly impact many clinical testing laboratories, public health laboratories, healthcare providers, and patients throughout the United States.”
AACC and other stakeholders have criticized the VALID Act because it would create duplicative regulation of laboratory services under FDA. Laboratories and LDTs already are regulated under CLIA and the Centers for Medicare and Medicaid Services.
Members of the laboratory community are invited to participate in AACC's advocacy work by contacting their representatives in Congress using AACC's Laboratory Voice tool.
Report Shows Government’s Strategy on Supply Chain for Testing
The new report from the Department of Health and Human Services (HHS) reveals how the agency is working on the country’s public health supply chain, and it outlines additional actions the government can take to build on progress, including in clinical laboratory testing.
Over the last 2 years, the government has funded capital purchases to build, expand, and improve production of test kits and supplies, such as swabs and reagents, and it’s also worked on information sharing with test suppliers to help sync production capacity with demands.
Going forward, HHS believes it can help lower the cost of test kit components by funding development of new manufacturing processes. HHS also wants to research improving the shelf life of tests and reagents.
Additionally, HHS aims to improve test component interchangeability. Interchangeability of non-patented test components would ensure vendors are producing interchangeable supplies, increase the volume of common components, and reduce spot shortages, the report says. It notes that “improving human capital through training and education, while a difficult challenge, could improve test production, and warrants further investigation.”
Administration Unveils New ACO Model
The Centers for Medicare and Medicaid Services (CMS) announced a redesigned Accountable Care Organization (ACO) model focused on equitable outcomes through what the agency calls “high quality, affordable, person-centered care.” The ACO Realizing Equity, Access, and Community Health (REACH) model is a redesign of the Global and Professional Direct Contracting (GPDC) model. ACOs allow groups of healthcare providers to work together under an agreement with CMS that can enable them to share potential cost savings that result from better coordinated care.
CMS says it will be a core principle for ACOs to “extend their reach into underserved communities to improve access to services and quality outcomes.”