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ACLA Evaluating Draft FDA Guidance Documents, Calls on Administration to Work with Congress and Stakeholders on Comprehensive Diagnostic Reform

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(WASHINGTON, DC) – The American Clinical Laboratory Association (ACLA) – the nation’s largest organization representing the public policy interests of clinical laboratories – called on the Administration to work with Congress and clinical laboratory stakeholders on comprehensive diagnostic reform in the wake of last night’s release of two new draft FDA guidance documents on Next Generation Sequencing (NGS), a method for performing genetic tests.

“ACLA supports the spirit of the President’s efforts to advance precision medicine,” said Alan Mertz, President of ACLA. “However, ACLA continues to assert that laboratory developed tests (LDTs) are not medical devices, including those LDTs that utilize NGS technology.  While we recognize the FDA is looking for innovative solutions, these proposals show the inherent difficulty of attempting to shoehorn LDTs into medical device standards.”

The FDA has issued numerous proposals and statements in recent years threatening to mandate medical device standards for LDTs on top of federal standards for clinical laboratories already existing under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), which are administered by the Centers for Medicare and Medicaid Services (CMS).  Both the House Energy & Commerce Committee and the Senate Committee for Health, Education, Labor & Pensions have signaled their interest in reforming the statutes in this area, with Energy & Commerce releasing a discussion draft to this effect last October.

“ACLA has been working in a bipartisan fashion with Congress and other stakeholders on proposals to update decades-old laws, to ensure that clinical laboratory innovation continues and that patients have robust access to these advances.  We respectfully call on the Administration to engage fully and transparently in this process so that we can achieve true statutory reform that benefits patients.  The time is now, let’s work together.”

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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 CMS Decision to Delay New Payment System, Evaluating Final PAMA Rule

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(WASHINGTON, DC) –The American Clinical Laboratory Association (ACLA) – the nation’s largest organization representing the public policy interests of clinical laboratories — is reviewing the final rule released today by the Centers for Medicare and Medicaid Services (CMS) to implement the Clinical Laboratory Fee Schedule (CLFS) provisions of the Protecting Access to Medicare Act (PAMA).

ACLA commended CMS on its decision to delay the implementation of the new payment system until January 1, 2018. ACLA called for the implementation delay in its comments to the proposed rule, as did members of the Ways & Means Committee, the leadership of the Senate Finance Committee, and organizations such as the American Hospital Association, American Medical Association, and National Independent Laboratory Association.

Although its evaluation has just begun, when comparing the final rule to the proposed rule, ACLA noted there appear to be some improvements in several key areas, including the definitions of applicable laboratory and advanced diagnostic laboratory test.

“Since Congress began consideration of reform of the 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, said Alan Mertz, President of ACLA, “The establishment of a market-based system for determining Medicare reimbursement for laboratory services was clearly preferable to the alternative – unlimited cuts to payment rates by CMS through its technological changes authority, as well as across the board reductions to the CLFS by Congress. ACLA’s next step is to evaluate completely this final rule, and consult with our membership.”

Mertz concluded, “At the heart of the clinical lab community is a shared mission to provide physicians and patients with accurate diagnostic information that will enhance treatment decisions and health outcomes. A payment system that recognizes value and spurs innovation will protect patient access and allow for even greater scientific discoveries that will continue to positively transform the practice of medicine.”

 

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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 Commends House Appropriations Committee for Including Language in Agriculture-FDA Spending Bill Report Directing FDA To Suspend Draft Guidance to Regulate LDTs

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WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today applauded House Appropriations Committee Chairman Harold Rogers, R-KY and Subcommittee Chairman Robert B. Aderholt, R-AL, for including report language in the agriculture-FDA appropriations bill that directs the Food and Drug Administration (FDA) to suspend efforts to finalize the LDT guidance, and instead work with Congress to develop a new pathway to regulate LDTs.

“The clinical lab community praises the leadership of the House Appropriations Committee and applauds the inclusion of report language supporting the ongoing work of the authorizing committees on a legislative solution to the regulation of LDTs,” said Alan Mertz, President of the ACLA. “The language in the bill report recognizes the need to suspend the Final FDA Guidance while Congressional authorizing committees work with laboratories, diagnostic manufacturers, providers and patients on a comprehensive framework that supports innovation and personalized patient care. This is consistent with ACLA’s position.”

The language regarding the regulation of LDTs in the report accompanying the bill making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies for fiscal year 2017 states:

“The FDA’s draft guidance issued on October 3, 2014, titled ‘Framework for Regulatory Oversight of Laboratory Developed Tests’’ (LDTs), puts forth a proposed regulatory framework that is a significant shift in the way LDTs are regulated. Such a shift deserves input from the public, and Congress has been working with stakeholders, constituencies, and the FDA to find common ground on regulating LDTs. The FDA’s guidance circumvents the normal rulemaking process and changes expectations for patients, doctors, and laboratories for the first time since the Clinical Laboratory Improvement Amendments Act was passed in 1988. The Committee directs the FDA to suspend further efforts to finalize the LDT guidance and continue working with Congress to pass legislation that addresses a new pathway for regulation of LDTs in a transparent manner.”

“Today’s committee action marks a critical next step in supporting ongoing patient access to life-saving diagnostic innovation,” said Mertz. “ACLA maintains that the FDA lacks the statutory authority to regulate LDTs as medical devices and is committed to working with Congress, the Agency and other stakeholders on a comprehensive legislative solution.”

 

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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 Commends Chairman Tiberi, Reps. Pascrell and Meehan for Bipartisan House Ways and Means Committee Letter to CMS Calling for PAMA Implementation Delay

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WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) today applauded House Ways and Means Health Subcommittee Chairman Pat Tiberi (R-OH), and his Ways and Means colleagues Bill Pascrell (D-NJ) and Pat Meehan (R-PA), along with 24 other committee members, for sending a bipartisan letter to Andy Slavitt, Acting Administrator for the Centers for Medicare & Medicaid Services (CMS), urging CMS to delay implementation of Section 216 of the Protecting Access to Medicare Act (PAMA).

The letter cites concerns that the implementation process for the new market-based payment methodology for the Clinical Lab Fee Schedule (CLFS) will be improperly rushed since CMS has yet to issue a final rule.

The letter states:

“Updating the CLFS is a highly complex task with significant implications for all stakeholders, with a reach far beyond the Medicare program.  We believe the critical alterations to the CLFS must be accomplished in a deliberate and measured manner, so that laboratories have sufficient time, once the final rule and subregulatory guidance are issued, to comply.  Given the delays in the rulemaking process, the January 1, 2017 effective date for the new CLFS payment methodology is not feasible and should be delayed.”

The letter also points out that while Section 216 of PAMA called for a January 1, 2017 implementation date for the new payment system, the legislation also included two other deadlines of significance that have not yet been met by CMS, including publication of a final rule by June 30, 2015, and reporting of prices beginning on January 1, 2016.

Expressing concern that these deadlines have not been met by CMS, the letter states:

“Congress set up this specific set of milestones to ensure that laboratories and CMS would have sufficient time to collect, report, submit and analyze private payor data, and establish new reimbursement rates.  We strongly believe this timeframe is necessary to successfully implement market-based reform.”

“The clinical laboratory community greatly appreciates the leadership of Representatives Tiberi, Pascrell and Meehan in calling for fairness and reason as we undertake this transition to a market-based payment system,” said Alan Mertz, President of the ACLA. “A successful transition – marked by reasonable and achievable milestones for clinical laboratories – is in the best interest of patients, clinical laboratories, and the Medicare program as whole.”

To read the letter in its entirety, 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. 

The American Clinical Laboratory Association Announces the Election of its 2016 Board of Directors

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(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today announced the election of the 2016 Board of Directors for the nation’s largest trade association representing clinical laboratories. Following ACLA’s annual conference on March 3, Board members elected to hold office are Quest Diagnostics Incorporated President & CEO Stephen H. Rusckowski, for a third consecutive year-long term as Chairman of the Board, Curtis A. Hanson, MD, Chair of Laboratory Medicine and Pathology for the Mayo Clinic as Vice-Chair and Jerry W. Hussong, M.D., Chief Medical Officer and Director of Laboratories for ARUP as the association’s Secretary-Treasurer.  ACLA board officers serve from March 2016-March 2017.

“ACLA is fortunate to have such strong leadership and representation from the clinical lab community reflected in our Board of Directors,” said Alan Mertz, President of ACLA. “The laboratory community applauds this august group of industry leaders as diagnostic innovation continues to play a critical role in patient care.”

For the complete list of ACLA 2016 Board of Directors 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. 

The American Clinical Laboratory Association Announces the Promotion of Julie Khani to Executive Vice President

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(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today announced the promotion of Julie Khani to Executive Vice President (EVP) by the ACLA Board of Directors for the nation’s leading organization representing clinical laboratories. Khani joined ACLA in the newly created position of Senior Vice President in 2013 to oversee the advocacy and policy operations and ACLA’s divisional vice presidents. In her new role as EVP, Khani will take on additional management responsibilities encompassing association operations and policy initiatives impacting the clinical laboratory industry.

“Julie’s tenure at ACLA has been marked by outstanding leadership and a keen understanding of public policy that has helped position ACLA before Congress and the administration as a leading advocate and expert on clinical laboratory issues,” said Alan Mertz, President of ACLA. “Clinical laboratories are faced with numerous challenges involving reimbursement and regulatory oversight and Julie’s command of the issues and her strategic direction are enormous assets for ACLA.”

Prior to joining ACLA, Khani served in senior roles at the National Association of Chain Drug Stores (NACDS) as Vice President, Public Policy, and formerly Director, Federal Legislative Affairs. During her tenure at NACDS, Khani was instrumental in the inclusion of pharmacy access standards in the Medicare Part D benefit, establishing incentives for TRICARE beneficiaries to obtain immunizations at retail pharmacies, and played a leading role in implementation of the Affordable Care Act provisions on pharmacy reimbursement for generic drugs. Previously, Khani served as Legislative Manager at Ford Motor Company, where she was responsible for health and labor issues and the company’s political action committee. She holds a bachelor of arts from New York University and a master of public administration from George Washington University.

“Diagnostic innovation has hit center stage as personalized medicine and its life-changing ramifications have become a reality in efforts to prevent and treat cancer and other diseases,” said Khani. “This is an exciting time to be a part of an industry that is making a difference in the lives of patients and I look forward to advancing the goals and mission of the clinical laboratory community.”

 

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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.