WASHINGTON, D.C. — In light of recent concerns about the spread of COVID-19 in the United States, the American Clinical Laboratory Association (ACLA) is encouraging attendees to go handshake-free at Wednesday’s Annual Meeting.

“As leading voices within the clinical laboratory diagnostics community, attendees recognize the importance of aligning our practices with the industry’s core commitment to public health, the driving force that brings us together each year,” said ACLA President Julie Khani.  “While the Centers for Disease Control (CDC) has deemed the immediate health risk from novel coronavirus to be low, designating the meeting handshake-free is an easy, practical step that underscores our commitment to the health and safety of our colleagues and communities.”

ACLA encourages all attendees to practice every day preventative measures in accordance with CDC guidelines, including:

• Cover your cough or sneeze with a tissue.
• Wash your hands often with soap and water for at least 20 seconds.
• Avoid touching your eyes, nose and mouth.

For more information, please visit the CDC website.

About ACLA’s COVID-19 Response Efforts

On Saturday, February 29, the FDA issued new guidance for high complexity laboratories, including commercial laboratories, to perform coronavirus testing as soon as validation is complete. ACLA members are working to develop novel tests for COVID-19, as well as supporting other ways to bolster testing capacity. Over the past several weeks, the CDC has been actively utilizing ACLA and the MOU to keep ACLA member laboratories with infectious disease expertise informed on the progression of the current outbreak, the government response, and how our member laboratories can best be prepared to support those efforts. This MOU was established as public and commercial health partners reflected on the Zika outbreak and how to strengthen communication and coordination in future health emergencies. This past summer, ACLA and several of our members also participated in a tabletop exercise at the CDC that simulated a real-life infectious disease outbreak, requiring participating organizations to put their rapid response plans to the test and identify gaps and potential solutions to guide future preparedness efforts.

About ACLA’s Annual Meeting

ACLA’s Annual Meeting convenes key policymakers and leaders from the clinical laboratory diagnostics community for presentations and discussions about the dynamic landscapes that will have significant impact on the next generation of diagnostics and laboratory tests for patients. This year’s speakers include FDA Commissioner Stephen Hahn and Rep. Scott Peters (D-CA).

About The American Clinical Laboratory Association (ACLA)

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

WASHINGTON, D.C.—The American Clinical Laboratory Association (ACLA) today announced the promotions of Thomas Sparkman to Senior Vice President of Government Affairs and Policy, and Andrew Young to Senior Coordinator.

“Over the past seven years, Tom has been instrumental in advancing ACLA’s key priorities in front of Congress and the Administration, including recent passage of the Laboratory Access for Beneficiaries (LAB) Act,” said Julie Khani, President of ACLA. “His extensive background in health care and government affairs is a great asset to our members and he will continue to play a key leadership role in this expanded policy position.”

In his new position as Senior Vice President of Government Affairs and Policy, Sparkman will be responsible for leading ACLA’s legislative and advocacy priorities. Prior to joining ACLA in 2013, Sparkman worked as a lobbyist representing numerous biotech and medical device innovators, hospitals and other providers. Previously, Sparkman held positions with the National Association of State Medicaid Directors and the National Association of Chain Drug Stores. Sparkman holds a Bachelor of Pharmacy from Rutgers University, a Master of Public Policy from Georgetown University and a Juris Doctor from American University and is licensed as a pharmacist in the Commonwealth of Virginia and an Associate Member of the Virginia State Bar.

ACLA has also promoted Andrew Young to a new role as Senior Coordinator.

“Since joining ACLA in 2017, Andrew has established himself as an indispensable member of our team,” said Khani. “Many of ACLA’s key projects wouldn’t have been possible without Andrew’s support and dedication, and we look forward to him taking on a greater role across the association.”

In his new position, Young will be responsible for driving key aspects of member engagement and day-to-day operations across the organization. Before joining ACLA, Young was a political consultant on the 2016 campaign trail. Andrew previously served as the Wayne Townsend Legislative Fellow in the office of U.S. Senator Joe Donnelly, where he worked on a range of policy issues, including health care. Young holds a degree in Political Science and a minor in Public and Environmental Affairs from Indiana University.

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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

As seniors brace for a new set of cuts to clinical lab services in January, Congress takes decisive action to halt faulty data collection process responsible for year-over-year cuts to Medicare lab benefits

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Independent study will assess how to improve data reporting under PAMA

WASHINGTON, D.C. – In a victory for 53 million seniors who depend on clinical laboratory diagnostics for their health, Congress today passed the Laboratory Access for Beneficiaries (LAB) Act, bipartisan legislation to address critical data collection deficiencies resulting in year-over-year cuts to Medicare lab benefits.

The LAB Act paves the way for additional reforms to the 2014 Protecting Access to Medicare Act (PAMA) by delaying the upcoming data reporting period by one year and commissioning a study on how to improve data collection and rate setting to better reflect Congress’ original intent of a market-based fee schedule for clinical laboratory services.

The passage follows a multi-year effort by ACLA and other stakeholders to raise the alarm about the urgent threat facing seniors who rely on lab tests to manage, diagnose and treat disease. Eighty percent of seniors have at least once chronic condition, according to the CDC, and routine monitoring is an essential component of care for this demographic.

While PAMA aimed to protect beneficiary access by establishing a market-based system for determining lab reimbursement rates, the Centers for Medicare and Medicaid Services (CMS) instituted a flawed data collection methodology that excluded information from the vast majority of laboratories and instead relied on a tiny, non-representative sample to determine rates. As a result, reimbursement for key tests that seniors use to manage chronic disease have been drastically cut over the past several years.

The consequences have been severe. According to a survey by the Infectious Disease Society of America (IDSA), over 79% of respondents will be unable to provide the full range of testing needed to rapidly diagnose infectious diseases following the PAMA cuts of 2018 and 2019. In addition, over 32% of respondents have changed their test menus and nearly 40% now refer more tests to another laboratory, which can cause life-threatening delays in diagnosis and care for patients.

“While we join with laboratories and the patients they serve to celebrate today’s victory, we also acknowledge the ongoing harm facing seniors who rely on lab services as a key element of their routine care and who will endure yet another new round of cuts next month,” said ACLA President Julie Khani. “Fortunately, Congress’ decisive action today puts us on the path to enact meaningful PAMA reforms that will protect seniors’ access to essential lab services, as the law originally intended.”

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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.

WASHINGTON, D.C. – Ahead of a crucial deadline to safeguard seniors’ access to lifesaving clinical laboratory services, Sen. Richard Burr (R-NC) and Sen. Sherrod Brown (D-OH) introduced the Laboratory Access for Beneficiaries (LAB) Act, bipartisan legislation to address critical data collection deficiencies resulting in year-over-year cuts to Medicare lab benefits.

Like its counterpart in the House of Representatives (H.R. 3584), the Senate bill (S. 3049) would delay the upcoming flawed data reporting process that is responsible for millions of seniors losing access to laboratory services.

The introduction comes amid a growing chorus of concern about the harm facing Medicare beneficiaries who are highly dependent on routine lab tests for their health. Last week, more than 30 leading health organizations, including the American Clinical Laboratory Association (ACLA), urged congressional leadership to advance the LAB Act as part of “must pass” end-of-the-year legislation to protect seniors from continued erosion of their lab benefits.

These ongoing cuts are a direct result of the Centers for Medicare and Medicaid Services (CMS) ignoring congressional direction in implementing the 2014 Protecting Access to Medicare Act (PAMA). The law directed CMS to establish a new market-based system for laboratory reimbursement, yet the agency only collected payment data from less than one percent of the nation’s labs – excluding the overwhelming majority of the market. This unrepresentative sample of laboratory rates consequently resulted in staggering year-over-year cuts to the routine tests that seniors rely on to manage diabetes, heart disease, cancer and countless other chronic conditions.

A new round of cuts – informed by incomplete data – is already slated for implementation January 1, 2020. If Congress fails to pass the LAB Act and delay the upcoming data reporting period (January 1 – March 31, 2020) before the end of the year, CMS will undoubtedly repeat the same flawed data collection process. As a result, rates implemented January 2021 will be based on unrepresentative data as well.

In addition to suspending the upcoming data reporting period, the LAB Act would also call for a nonpartisan study to provide recommendations on how best to implement a revised data collection process and rate-setting methodology. Together, these core reforms would support a market-based reimbursement system for laboratory services and maintain seniors’ access to vital Medicare benefits, as Congress originally intended.

“Make no mistake about it, the faulty implementation of PAMA has resulted in severe consequences for Medicare beneficiaries who depend on clinical laboratory diagnostics to manage, treat and diagnose disease,” said ACLA President Julie Khani. “We’re grateful to Sens. Burr and Brown for introducing the LAB Act and standing up for seniors across the country. It’s vital that we secure access to these lifesaving tests and continue to safeguard seniors’ health.”

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ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, hospital, ESRD and nursing home laboratories. The clinical laboratory industry employs nearly 295,000 people directly, and generates over 117,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $106 billion to the nation’s economy.