Quick Links
Who is NILA? Fact sheet on NILA and community/regional clinical laboratories
NILA’s Advocacy Achievements
NILA’s Current Activities
NILA Member Benefits
What is NILA
The National Independent Laboratory Association (NILA) is a trade association for community, regional, and health system clinical laboratories. NILA serves as a platform for laboratory owners and senior executives (CEO, COO, President, Vice-President, etc.) to share business expertise, focus on legislative and regulatory issues, work together to address industry concerns, and to improve the operations of NILA’s member laboratories.
NILA’s Advocacy Achievements
2024
- Continuing to urge the U.S. Congress to pass the Saving Access to Laboratory Services Act (SALSA).
- Continuing to work with other laboratory organizations to oppose the FDA's final rule to regulate LDTs as medical devices.
2023
- Submitted comments in opposition to the FDA's proposed rule to regulate Laboratory Developed Tests (LDTs) as medical devices.
- Continued participation in a Memorandum of Understanding (MOU) with 8 other government and professional organizations to provide for Diagnostic Surge Testing Capacity for Public Health Emergencies.
- Successfully urged the bipartisan, bicameral Congressional sponsors of the Saving Access to Laboratory Services Act (SALSA) to reintroduce the legislation in the 118th Congress, which was reintroduced on March 28, 2023.
- Successfully urged the U.S. Congress to once again approve a one-year delay to cuts of up to 15% to Medicare's Clinical Laboratory Fee Schedule (CLFS) that were scheduled to be implemented on January 1, 2024, under the PAMA statute, and to delay, for one more year, PAMA's data reporting requirement that was to begin on January 1, 2024.
- Successfully urged U.S. House/Senate leaders to exclude the VALID Act from year-end 2023 legislation.
2022
- Recommended an increase in Medicare's specimen collection fee from $3.00 to $8.27. CMS, after proposing to keep the specimen collection fee at $3.00 (where it had been since 1984), decided to increase the specimen collection fee, effective January 1, 2023, to $8.57, and to $10.57 for a specimen collected from a Medicare beneficiary in a skilled nursing facility or on behalf of a home health agency.
- Successfully urged the U.S. Congress to approve a one-year delay to cuts of up to 15% to Medicare's Clinical Laboratory Fee Schedule (CLFS) that were scheduled to be implemented on January 1, 2023, under the PAMA statute.
- Successfully urged U.S. House/Senate leaders to exclude the VALID Act from year-end 2022 legislation
2021
- Achieved a delay in implementation of United HealthCare’s Designated Diagnostic Provider (DDP) Program, which limits full coverage of diagnostic services to laboratories that are both in-network and approved DDP providers.
- Published a white paper on Laboratory Developed Tests (LDTs) to help policy makers understand the important role LDTs play in patient care and the potential consequences of enacting restrictive policies.
- Disseminated a set of recommendations aimed at reforming the Protecting Access to Medicare Act (PAMA), which has disproportionately harmed independent laboratories.
- Created and made available new advocacy materials to empower NILA members to advocate for policies that address key issues facing independent laboratories.
2020
- Obtained additional one-year delay in reporting private payor data plus a one-year delay in additional PAMA cuts to the Part B CLFS.
- Advocate for and received direct funding to laboratories to help during COVID-19 pandemic.
2019
- Persuaded Congress to “fix” PAMA through the LAB Act (HR 3584), which was signed into law on December 20, 2019.
- Cosigned with 30 other laboratory organizations a December 2, 2019, letter to Congress supporting Passage of the LAB Act (H.R. 3584).
- Engaged in efforts to amend laboratory provisions in the “Eliminating Kickbacks in Recovery Act (EKRA).”
2018
- Filed two amicus curiae briefs in support of lawsuit challenging CMS’s implementation of the PAMA regulations.
2017
- 60-day delay (until May 30, 2017) of the March 31, 2017, deadline for reporting private payor data to CMS.
2016
- A letter to CMS signed by 88 Members of the U.S. House of Representatives expressing concern about the implementation of Section 216 of PAMA requiring the reporting of private payor payment rates.
- CMS agreeing to NILA’s request to reprice definitive drug testing codes G0480-G0483.
- The withdrawal of the FDA’s October 3, 2014, Draft Guidance’s regulating Laboratory Developed Tests (LDTs).
2015
- No Laboratory Fee Schedule cuts in the permanent “Doc Fix” (SGR) legislation.
2014
- A $2 increase in specimen collection fees for SNF/homebound patients.
2013
- Winning several lawsuits that forced the New York State Health Department to refund over $23 million in Permit Fees/Overcharges to New York licensed laboratories.
2011
- Repealing a CMS Requirement for physician signatures on all Part B clinical laboratory requisitions.
2007
- Blocking CMS’s Competitive Bidding Demonstration Project for Part B CLFS payments.
2003
- Defeating a Congressional proposal to reinstitute a 20% copayment on Part B Clinical Laboratory Fee Schedule (CLFS) payments.
NILA’s Current Activities
- Saving Access to Laboratory Services Act (SALSA) - NILA is advocating for Congress to repair the improper implementation of the Protecting Access to Medicare Act (PAMA) by enacting SALSA. SALSA would protect laboratories from potentially damaging cuts scheduled to take effect in 2024. In the long term, SALSA would fix the flawed data reporting and rate setting methodology implemented by PAMA, protecting laboratories from drastic cuts to Medicare's Clinical Laboratory Fee Schedule (CLFS) and creating a more sustainable reimbursement system for future years. Click here to learn more about SALSA.
- Oversight of Laboratory Developed Tests (LDTs) - NILA is following efforts by legislators and federal agencies to reform the oversight of laboratory developed tests. The Verifying Leading-Edge IVCT Development (VALID) Act, which would grant broad authority to FDA to regulate LDTs under a new regulatory pathway, has been reintroduced in the House of Representatives. While future prospects for the legislation are uncertain, the FDA is also advancing draft guidance asserting its authority to regulate these tests. NILA continues to follow these actions and advocate on behalf of NILA members.
- Drug Testing Reimbursement - NILA contacted CMS requesting the agency immediately rescind National Correct Coding Initiative (NCCI) edits created to disallow payment for a definitive drug test when performed on the same patient, on the same day as the presumptive drug test. NILA also requested that CMS immediately restore payment for presumptive and definitive tests as they were prior to implementation of the edit on July 1, 2023. Our efforts were instrumental in persuading CMS to announce that the edits will be rescinded. Updated NCCI edit files will be posted on October 1, 2023, and removal of the edit will be retroactive to July 1, 2023, meaning that any claim affected by the procedure-to-procedure edit will be processed and paid as appropriate under existing payment and coverage policies.
- NILA is advocating for COVID-19 relief for laboratories including urging Congress and the Administration to alleviate COVID-19 testing supply shortages; advocating for reasonable data reporting requirements; and analyzing and responding to emerging regulations, including those that impact reimbursement for COVID-19 testing.
- Protecting Access to Medicare Act (PAMA) – NILA is following MedPAC’s review of laboratory payment rates and communicating the devastating impact of PAMA on laboratories. MedPAC’s report to Congress is due in June 2021.
- 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; following proposed changes to the Affordable Care Act (Obamacare); problematic and aggressive audit programs; and increased fraud and abuse enforcement.
NILA Member Benefits
- Networking with fellow laboratory owners and senior laboratory executives to share information and address issues concerning your laboratory and the laboratory industry
- Representing your laboratory's interest before federal, state, and local lawmaking bodies and regulatory agencies
- Periodic conference calls with NILA's Washington representatives to update you on the latest legislative and regulatory issues
- "Alerts" and "Updates" on important legislative, regulatory and laboratory industry issues
- Individualized Assistance – Call us with your questions/problems
- Access to NILA’s “Lab Leaders Forum” – Offers clinical laboratory executives the ideal platform for personal interaction and shared views
- Professional, General Liability Insurance – High quality, economical professional liability insurance for individual NILA laboratory directors and supervisors, as well as all lines of coverage usual to laboratories for NILA member laboratory facilities. For details, visit www.aab.org or call Gina M. Matarazzo, Sallop Insurance, Inc., (617) 488-6612
- Valuable continuing education programs that you and your employees can participate in to earn continuing education credit, study for certification examinations, and update and add to your knowledge
- Free subscription to the AAB Bulletin