What is NILA Working on?

NILA recently established a “Pre-Payment Review” Committee to address the problems NILA members are experiencing with insurance company policies regarding pre-payment and prior authorization reviews. NILA’s Pre-Payment Review Committee has already contacted two major insurers and will meet with them soon to discuss the problems NILA members are experiencing.

Opioid Task Force - NILA has created an Opioid Task Force to communicate the critical role that toxicology and community laboratories fulfill in combating the opioid epidemic. NILA has signed onto a letter from the Addiction Policy Forum addressed to the Chairs and Ranking Members of the U.S. House and Senate Appropriations Committees regarding the most effective way to use new government funding to address the opioid epidemic. The Addiction Policy Forum is a national nonprofit organization focused on improving policies related to substance abuse. NILA will continue to update members as NILA’s Opioid Task Force implements its strategy.

Medicare coding consolidation and price adjustments for a number of tests, particularly drugs of abuse testing. On July 18, 2016, the PAMA CDLT Advisory Panel voted in favor of a NILA proposal to reprice definitive drug testing codes G0480-G0483. Subsequently, CMS increased payment rates for codes G0480–G0483 by up to 47%, effective January 1, 2017. Recently, the “final” 2018 CLFS, which would have dramatically reduced Medicare payments for these codes over the next three years, was corrected by CMS based on a pricing formula adopted after NILA’s July 2016 proposals. As a result, reductions to definitive drug testing codes G0480–G0483 were changed from a 30% reduction over the next three years to a one-time 2.7% reduction in 2018 (and no additional cuts in 2019 and 2020).

PAMA Regulations - In February 2018, the American Association of Bioanalysts (AAB) (with NILA’s support), filed an Amicus Curiae brief in support of the lawsuit commenced by the American Clinical Laboratory Association (ACLA) challenging how the Secretary of HHS implemented PAMA. Another Amicus Curiae Brief was filed in December 2018. NILA continues to work with other stakeholders for a legislative solution to the problems with PAMA. Together with members of the Clinical Laboratory Coalition (CLC), NILA met with House Energy and Commerce and Ways and Means Committee staff to discuss the Clinical Laboratory Coalition’s legislative proposal. While nothing has been agreed to, NILA found it encouraging that Congressional staff forwarded the CLC’s draft legislation to the Congressional Budget Office (CBO) to be scored. This signals an interest from Congress in NILA’s legislative proposal to require a statistically valid, stratified, random sampling that represents all segments of the laboratory community and uses a weighted mean that is proportional to laboratory type, market share and geography instead of the current weighted median. NILA is continuing to meet with Congressional offices to explain how the PAMA fee schedule cuts are impacting NILA members.

FDA oversight of Laboratory Developed Tests (LDTs). The FDA was expected to finalize its October 3, 2014, draft guidances by the end of 2016, but instead published a “Discussion Paper” on January 13, 2017, pledging to work with Congress and the Trump Administration to develop a new regulatory system for LDTs. NILA continues to work with other laboratory and health care organizations to find alternatives to the FDA’s draft guidances. Legislation was introduced in Congress in 2017 to authorize the FDA to regulate all LDTs. In August 2018 the FDA released a “Technical Assistance” document in response to that legislation. NILA is reviewing the FDA’s Technical Assistance document and will be developing a position on it.

Navigating the dramatic changes in the U.S. health care system, including the exclusion of community and multi-state regional laboratories from managed care “sole source” contracts; anticipated changes to the Affordable Care Act (Obamacare) under the Trump Administration; problematic and aggressive audit programs; and increased fraud and abuse enforcement actions.