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Rep. Michael Burgess to Provide a View on Health Care From Capitol Hill at 2017 ACLA Annual Meeting

(Washington, D.C.) – Adding to the list of esteemed health policy speakers presenting at the annual conference of the nation’s largest trade association representing clinical laboratories, the  American Clinical Laboratory Association (ACLA), announced today physician and Chair of the House Energy & Commerce Subcommittee on Health, Rep. Michael Burgess (R-TX), M.D., will address pressing health care issues during the first 100 days of the Trump Administration and the 115th Congress.

“One of the most important and influential voices in health care policy today, Chairman Burgess has demonstrated a keen understanding of issues facing the clinical laboratory community,” said Julie Khani, president of ACLA.  “ACLA members are looking forward to hearing from the chairman regarding policy impacting diagnostic innovation and its role in ongoing advances in patient care.”

ACLA’s annual meeting will be held March 23rd, 2017 at the Grand Hyatt Hotel in Washington, D.C.  Joining Burgess in addressing representatives from laboratories, government, patient and the payor community are Marc Boutin, CEO of the National Health Council who will be moderating a panel featuring patient advocacy organizations, Karen Glassman of the Health and Human Services (HHS) Office of the Inspector General (OIG) and keynote speaker Siddhartha Mukherjee, M.D., Assistant Professor of Medicine at Columbia University, the author of The Emperor of All Maladies:  A Biography of Cancer, and winner of the 2011 Pulitzer Prize for general nonfiction.

“ACLA’s annual meeting is scheduled at an opportune time that will allow for thoughtful perspectives from leaders in the legislative and regulatory policy arena and those on the cutting edge of medical science,” said Julie Khani, president of ACLA.  “Our meeting agenda represents the exciting intersection of health care policy and advances in innovation – both of which will lead the way in precision medicine and the quest for effective treatments and cures.”

ACLA’s annual conference is the premier meeting for the clinical lab community that brings together national leaders in the diagnostic sector, payors, patients, congressional lawmakers and administration officials for presentations and discussions on federal legislative and regulatory policy.

For more information, visit the ACLA annual meeting website, click here.

 

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The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies. 

 

Statement from the American Clinical Laboratory Association on the FDA Discussion Paper on LDTs

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) – the nation’s largest organization representing the public policy interests of clinical laboratories – is reviewing the discussion paper on laboratory developed tests (LDTs) released today by the Food and Drug Administration (FDA).

“ACLA applauded the FDA’s recent announcement that it would not issue a final guidance on LDTs, and importantly we note that today’s document is not an official nor enforceable policy from the agency,” said Julie Khani, president of ACLA.  “We have consistently maintained that LDTs are not medical devices and cannot and should not be regulated as such.  The clinical laboratory community is pleased the FDA acknowledges that stakeholder input and the ongoing bipartisan work by Congress is the appropriate process to advance comprehensive reform of the LDT regulatory framework.”

Khani added that ACLA looks forward to working with Congress, the Administration, patients and other stakeholders on diagnostic reform that avoids duplication, promotes innovation and advances patient care.

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The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.

ACLA Applauds Appointment of Rep. Michael Burgess, M.D. as Chairman of House Energy and Commerce Health Subcommittee

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today commended the appointment of Rep. Michael Burgess, M.D. (R-TX) as Chairman of the Health Subcommittee for the House Energy and Commerce Committee calling the physician and policymaker a “stalwart supporter of diagnostic innovation who recognizes its crucial impact on patient care.”

“Rep. Burgess has consistently demonstrated a deep and extensive understanding of health care and in particular, the issues facing clinical laboratories,” said Julie Khani, president of ACLA.  “Having a physician taking the reins of a key subcommittee is a welcome development on Capitol Hill and we look forward to working closely with Rep. Burgess and Chairman Walden on issues critical to diagnostics and the patient community.”

Khani further noted, “The future of precision medicine is dependent upon robust diagnostic innovation and pragmatic public policy. ACLA members are encouraged by Rep. Burgess’ leadership appointment and pledge to work diligently with the committee to maximize patient access to diagnostics and effective treatments.”

 

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The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies. 

Siddhartha Mukherjee, MD to Keynote 2017 ACLA Annual Meeting

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) announced today that Siddhartha Mukherjee, M.D., will be the keynote speaker at the organization’s annual meeting on Thursday, March 23rd, 2017, in Washington, DC.   Dr. Mukherjee is the author of The Emperor of All Maladies:  A Biography of Cancer, and winner of the 2011 Pulitzer Prize in general nonfiction.  His new book, The Gene:  An Intimate History, debuted at #1 on the New York Times bestseller list.

“Dr. Mukherjee is one of the foremost scientists leading revolutionary research in the quest to understand the vast complexities of cancer,” said Julie Khani, president of ACLA.  “A riveting speaker and tireless advocate for personalized cancer care, Dr. Mukherjee recognizes the value of diagnostic innovation in the fight against this pervasive disease.”

ACLA’s annual conference is the premier meeting for the clinical lab community that brings together national leaders in the diagnostic sector, payors, patients, congressional lawmakers and administration officials for presentations and discussions on federal legislative and regulatory policy.

Given the shared focus on precision medicine and the cure for cancer in both the scientific and healthcare policy communities, Mukherjee will offer a unique perspective to attendees invested in diagnostic innovation and groundbreaking medical discoveries.

Mukherjee is an Assistant Professor of Medicine at Columbia University. A Rhodes Scholar, he graduated from Stanford University, University of Oxford and Harvard Medical School.

For more information, visit the ACLA annual meeting website, click here.

 

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The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies. 

 

ACLA Reviewing HHS OIG Reports on Implementation of CLFS Reform

(WASHINGTON, DC) – American Clinical Laboratory Association (ACLA) President Alan Mertz issued the following statement today regarding the reports released by the Department of Health and Human Services Office of Inspector General (OIG) on Medicare payments for laboratory tests, and the status of efforts by the Centers for Medicare & Medicaid Services (CMS) to implement market based payment reform as called for by the Protecting Access to Medicare Act (PAMA):

“Since Congress began consideration of reform of the Clinical Laboratory Fee Schedule (CLFS), ACLA has advocated for a system that bases Medicare reimbursement on the broad scope of the laboratory market, encourages innovation, and protects access to laboratory services for Medicare patients.

We share some of the concerns raised by the OIG, namely that a significant portion of the laboratory market will be excluded from reporting private payor data, and limited time remains for CMS to provide labs with necessary information on key issues such as how tests can obtain advanced diagnostic laboratory test (ADLT) status.

However, ACLA takes exception to the suggestion by the OIG that ‘ongoing monitoring’ may be necessary in cases where payment rates increase.  In enacting PAMA, Congress was clear in its intent that Medicare reimbursement for laboratory testing services are to reflect true market rates.

ACLA has worked closely with Congress, CMS, the PAMA Advisory Panel, and other stakeholders on implementing CLFS payment reform.  While significant progress has been made, more work needs to be done before a new payment system that meets the requirements set forth by Congress is realized.  We remain committed partners in payment reform that is market based and provides Medicare patients with the benefits of diagnostic innovation.”

 

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About the American Clinical Laboratory Association

The American Clinical Laboratory Association (ACLA) is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.

ACLA Expresses Concern that CMS’ Gapfill Payment Rates Will Compromise Patient Access to Advanced Diagnostic Tests

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today stated its strong opposition to the 2016 Final Gapfill Payment Determinations, which include drastic cuts to Medicare payment rates for some Multianalyte Assays with Algorithmic Analyses (MAAAs), and Genomic Sequencing Procedures (GSPs). These reductions are far out of line with what the Medicare program has historically paid for these tests, and if implemented, will hamper innovation and turn back the clock on advances in precision medicine.

“The clinical lab community is urging CMS to reconsider these drastic payment rate cuts,” said Alan Mertz, President of ACLA. “Implementing these cuts will threaten Medicare patients’ access to these groundbreaking diagnostics that lead to more effective treatments.”

CMS’ 2016 Final Gapfill Payment Determinations slash Medicare reimbursement rates for some MAAAs and GSPs, two types of vital advanced laboratory diagnostic tests considered crucial aspects of the federal government’s Precision Medicine Initiative. Today, many of the tests falling into these categories are recognized as the standard of care for the diagnosis of certain conditions, or for the high-value prediction or monitoring of therapeutic response. MAAA and GSP tests are used to uncover individualized genetic information that allows physicians to better treat conditions such as cancer, cardiovascular disease, and rheumatoid arthritis.

Prior to the release of the final determinations, Sen. Richard Burr (R-NC), Sen. Michael Bennet (D-CO) and other U.S. Senators questioned the process by which the proposed preliminary rate cuts to these tests by CMS were determined and noted a wide disparity in preliminary payment rates that suggests an inconsistent application of the gapfill criteria. In a bipartisan letter sent last week to CMS’ Acting Director Andrew Slavitt, the senators stated, “We are concerned with the lack of transparency in the process by which these cuts have been proposed and the impact such significant cuts would have on patients’ access to these advanced tests.”

“Moving forward with draconian cuts to these critical tests is truly a step backward for medical science and patients,” said Mertz. “ACLA’s position remains steadfast in that reimbursement for diagnostic tests should reflect the true value of the service and impact it provides to patient care.”

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About the American Clinical Laboratory Association
The American Clinical Laboratory Association (ACLA) is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.

ACLA Commends Senate Effort to Combat Proposed Gapfill Measures, Protect Medicare Patient Access to Advanced Diagnostic Tests

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today applauded the patient advocacy efforts of Sen. Richard Burr (R-NC), Sen. Michael Bennet (D-CO) and other U.S. Senators who penned a bipartisan public letter to the Centers for Medicare & Medicaid Services (CMS), cautioning CMS against proposed rate cuts for necessary diagnostic tests.

Earlier this year, CMS unveiled its 2016 Preliminary Gapfill Payment Determinations. The proposal would slash Medicare reimbursement rates for two types of vital advanced laboratory diagnostic tests by up to 90 percent.  These innovative, molecular diagnostics include Multianalyte Assays with Algorithmic Analyses (MAAAs) and Genomic Sequencing Procedures (GSPs).  Both types of lab tests are crucial aspects of the federal government’s Precision Medicine Initiative, as they uncover individualized genetic information that allows physicians to better treat conditions such as cancer, cardiovascular disease, and rheumatoid arthritis.

As the Senators write in their letter, such severe payment cuts to vital diagnostic tests could “have a negative and potentially harmful impact on patient care” and “stifle the very innovation that is necessary to fulfill the promise of precision medicine.”

The Senators also expressed concern regarding the lack of transparency in CMS’ payment proposal process, stating that “while the agency is supposed to provide a public explanation as to how gapfill criteria is applied, CMS has yet to provide an explanation for the recently proposed preliminary pricing by its Medicare Administrative Contractors (MACs).” The lawmakers also noted a wide disparity in preliminary payment rates, which suggests an inconsistent application of the gapfill criteria.

“We are concerned with the lack of transparency in the process by which these cuts have been proposed and the impact such significant cuts would have on patients’ access to these advanced tests,” the letter notes.

Additionally, the lawmakers asserted that drastic cuts in reimbursement rates could conflict with the policy aims of the market-based Protecting Access to Medicare Act (PAMA), which “sought to ensure patient access to existing laboratory tests by establishing a transition period that would limit pricing reductions year-to-year.”  To read the letter in its entirety, click here.

“We applaud this bipartisan group of legislators for calling attention to the negative consequences of severe Medicare cuts for vital diagnostic tests,” said Alan Mertz, President of the ACLA. “We hope that CMS will carefully consider the harm these cuts pose and provide adequate pricing for these tests for the benefit of Medicare patients who rely on innovative lab testing to enhance treatments decisions and improve health outcomes.”

 

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About the American Clinical Laboratory Association

The American Clinical Laboratory Association (ACLA) is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.

 

The American Clinical Laboratory Association Commends Senate HELP Committee for Continuing Dialogue on Value of LDTs

WASHINGTON, D.C.  – In a letter to the Senate Health, Education, Labor and Pensions Committee (HELP), the American Clinical Laboratory Association (ACLA) today applauded the Committee for holding a hearing on the regulation of laboratory developed tests (LDTs) and outlined ten key principles to guide any reforms to oversight of these tests.

“We are heartened that Chairman Alexander (R-TN) and Ranking Member Murray (D-WA) are hosting a hearing on the value and role of LDTs, particularly in the context of precision medicine,” said Alan Mertz, President of ACLA.  “LDTs are a major catalyst for the Precision Medicine revolution, and their critical role is often overlooked.   For this revolution to continue, it’s critical that there be a clear and reliable regulatory system that doesn’t hamper LDT innovation, and that patients and doctors have continued access to these vital tests.”

In a letter to the Committee today, ACLA outlined key principles for any new statutory framework for modernizing the regulation of LDTs.  Included among the principles are that LDTs are not medical devices and cannot be regulated by the Food and Drug Administration (FDA) as such, and that any new framework must grandfather existing LDTs.  To view the full letter, click here.

“Putting the patient first is the priority for clinical lab scientists and diagnostic researchers across the country,” said Mertz.  “The clinical lab community appreciates the opportunity to continue to work with members of Congress and stakeholders with the objective of strengthening the current regulatory framework for these tests. Legislative reform is the most transparent and practical solution to ensure diagnostic innovation remains a leading factor in developing effective treatments and cures for disease.”

 

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The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.