2017 Minnesota Legislative Symposium

Overview of Political and Policy Environment

THE DIAGNOSTIC ACCURACY AND INNOVATION ACT

Advancing innovation and safety for patients in diagnostics

The DAIA addresses longstanding concerns with the regulation of diagnostic tests and will bring much needed certainty to the diagnostic industry and its critical role in patient care. This legislation ensures reasonable risk-based regulation, avoids duplicative regulation, advances precision medicine, and applies the same regulatory principles to the same activity regardless of where the test is developed. The DAIA also modernizes the Clinical Laboratory Improvement Amendments (CLIA) program at the Centers for Medicare & Medicaid Services (CMS) to maintain quality laboratory operations. The legislation assigns certain responsibilities to FDA (test development and manufacturing generally) and assigns exclusive jurisdiction over laboratory operations to CMS under CLIA.

Discussion Paper on Laboratory Developed Tests (LDTs)

January 13, 2017

The Food and Drug Administration (FDA) recently announced that we would not issue a final guidance on the oversight of laboratory developed tests (LDTs) at the request of various stakeholders to allow for further public discussion on an appropriate oversight approach, and to give our congressional authorizing committees the opportunity to develop a legislative solution.

In gathering feedback on the LDT draft guidances issued in 2014, we continuously engaged with interested stakeholders, including those groups that authored alternative proposals. We analyzed more than 300 sets of comments on the draft guidances and discussion from a subsequent public workshop held in 2015 as well as engaged in many meetings and conferences with various stakeholders. Because we did not issue a final guidance, all that is currently available to the public are the individual comments on the 2014 draft guidances submitted to the federal docket and the transcript of the workshop. In the absence of issuing final guidance and at the request of stakeholders, we feel it is our responsibility to share our synthesis of all the feedback we have received, with the hope that it advances public discussion on future LDT oversight.

Access to Clinical Laboratory Services in Jeopardy

Due to CMS Implementation of PAMA

The clinical laboratory community urges Congress and the Administration to ensure access to quality clinical laboratory services within the Medicare program will not be impeded by fee schedule cuts authorized within the Protecting Access to Medicare Act (PAMA) of 2014. Final regulations promulgated by the Obama Administration should be reviewed by the Trump Administration to ensure they do not destabilize the clinical laboratory testing market and impede access to care.

 

We urge the Trump Administration to:

*Extend the deadline for data collection and reporting periods for the clinical laboratory fee schedule(CLFS) under Medicare by twelve (12) months to March 31, 2018

 

*Delay enforcement of the updated CLFS until January 1, 2019

*Revise the definition of "applicable laboratory" to mean a facility identified by a Clinical Laboratory Improvement Act (CLIA) number, so that true market-based reimbursement rates can be calculated

Growing Crisis in the Clinical Laboratory Workforce

To ensure access to quality health care services the healthcare system must have an adequate supply of clinical laboratory personnel. Today that supply is in serious question. This shortage hampers the ability of clinical laboratories to meet patient testing demands, posing problems for patient health and welfare. Growing numbers of patients and the number and complexity of medical laboratory tests are putting strains on a profession growing modestly.

We call upon Congress to address this concern within the Veterans Health Administration and to begin to address the concern throughout our nation’s health care system.

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