What is NILA Working on?

PAMA – Protecting Access to Medicare Act – NILA filed two amicus curiae briefs in 2018 supporting a lawsuit challenging how the Secretary of HHS implemented PAMA. A court ruling that the method HHS used to implement PAMA could not be challenged in court was recently overturned on appeal. Summary judgement motions are now pending and should be decided in early 2020.

Meanwhile, NILA and other laboratory organizations have mounted a grassroots campaign in support of a bill introduced in the U.S. House of Representatives, the Laboratory Access for Beneficiaries Act (LAB Act – HR 3584), which would delay the next round of PAMA data reporting by one year (from 2020 to 2021) and authorize the National Academy of Medicine (NAM) to provide recommendations to Congress on less burdensome PAMA data collection methods and modifications to CMS’s reimbursement rate calculations.

NILA’s 3rd Party Insurance Payment Issues Task Force is addressing problems NILA members are experiencing with insurance company policies and payment practices. NILA’s 3rd Party Insurance Payment Issues Task Force has already met with one major insurer and is planning to meet with another to discuss the problems NILA members are experiencing.

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).

NILA’s Opioid Task Force is communicating the critical role that toxicology and community laboratories fulfill in combating the opioid epidemic. NILA has signed 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.

EKRA (Eliminating Kickbacks in Recovery Act of 2018) – NILA continues to push for an amendment to fix EKRA. EKRA removed fraud and abuse “safe harbors” on commissions paid to laboratory sales representatives. Meetings with a key Congressional Committee and Administrative agency have been held to try to work out a solution.

Surprise Billing – NILA is monitoring Congressional efforts to prevent insured patients from receiving “surprise” medical bills. This issue is especially important for “out-of-network” laboratories.

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.