NILA’s Advocacy Achievements
2025
- Increased Medicare's general Specimen Collection fee to $9.09 (from $8.83), and to $11.09 (from $10.83) for skilled nursing facilities and home health agencies.
- Increased Medicare's Travel Allowance mileage rate to $1.20 (from $1.13) and the Flat Rate Travel Allowance to $12 (from $11.30) for trips of less than 20 miles to/from one location (for one or more Medicare patients).
2024
- Successfully urged Congress to, once again, pass 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, 2025, under the PAMA statute, and to delay, for one more year, PAMA's data reporting requirement that was set to begin on January 1, 2025.
- Increased Medicare's general Specimen Collection fee to $8.83 (from $8.57), and to $10.83 (from $10.57) for skilled nursing facilities and home health agencies.
- Increased Medicare's Travel Allowance mileage rate to $1.13 (from $1.11) and the Flat Rate Travel Allowance to $11.30 (from $11.10) for trips of less than 20 miles to/from one location (for one or more Medicare patients).
- Continued to urge Congress to pass the Saving Access to Laboratory Services Act (SALSA) to replace PAMA, providing a long-term, sustainable solution for laboratory reimbursement.
- Organized and led a group of five clinical laboratory organizations in submitting an amicus curiae brief in support of a lawsuit challenging the constitutionality of the FDA's rule to regulate Laboratory Developed Tests (LDTs) as medical devices.
- Continued participation in a Memorandum of Understanding (MOU) with 10 other government and professional organizations including the FDA and the CDC to provide for Diagnostic Surge Testing Capacity for Public Health Emergencies.
- Formed a "Billing Problems" workgroup for NILA members to come together and discuss strategies to address billing and reimbursement problems from both private payers and Medicare/Medicaid.
2023
- Increased Medicare's general Specimen Collection fee to $8.57 (from $3.00), and to $10.57 (from $5.00) for skilled nursing facilities and home health agencies.
- Increased Medicare's Travel Allowance mileage rate to $1.11 (from $1.04) and the Flat Rate Travel Allowance to $11.10 (from $10.40) for trips of less than 20 miles to/from one location (for one or more Medicare patients).
- 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 worked with 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, and advocated for its passage.
- 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.