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ACLA Supportive of CMS Revisions to National Coverage Determination on the Use of Next Generation Sequencing in Cancer

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) expressed support today for revisions made by the Centers for Medicare and Medicaid Services (CMS) to the final National Coverage Determination (NCD) released today on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer. The association and other stakeholders submitted extensive comments to the agency on the proposed NCD to ensure that the policy would not deprive Medicare beneficiaries’ access to critical laboratory testing that is a key part of precision medicine.

“ACLA is pleased with the response from CMS to stakeholder concerns in the final NCD,” said Julie Khani, President of the ACLA. “ACLA supports pathways to coverage for molecular diagnostic tests, such as provided in this final NCD.  This policy strikes a good balance between providing a pathway to national coverage for certain tests and allowing the local Medicare contractors to determine coverage decisions for the remaining set.

“ACLA will continue to work with CMS and the local Medicare contractors as this policy is implemented to ensure that patients continue to have access to these innovative and clinically impactful tests,” continued Khani.

To view ACLA’s previously issued comments on CMS’ draft NCD click here.

ACLA Evaluating CMS’ Final National Coverage Determination on Next Generation Sequencing

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) stated that it is reviewing the Centers for Medicare & Medicaid Services (CMS) final National Coverage Determination (NCD) released today on Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer. The association had previously voiced concerns in response to the proposed NCD, cautioning that it would deprive Medicare beneficiaries of access to critical laboratory testing, which is a key part of precision medicine.

“ACLA is evaluating CMS’ final NCD released today on Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer,” said Julie Khani, president of the ACLA. “We recognize that CMS has made significant changes from the draft NCD as a result of the concerns expressed by many stakeholders.  We are evaluating the final NCD with our members, and will determine how it aligns with ACLA’s goals of maintaining access to laboratory testing for Medicare beneficiaries, and spurring continued innovation in this cutting-edge and clinically impactful testing.”

To view ACLA’s previously issued comments on CMS’ draft NCD click here.

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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, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.

ACLA Leads Clinical Laboratory Community in Urging CMS to Address State Medicaid Rate Cuts for Lab Services

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) along with a dozen clinical laboratory stakeholders sent a letter to Centers for Medicare and Medicaid Services (CMS) Administrator Seema Verma today urging her to discourage states from making cuts to Medicaid rates for lab tests. The letter notes that with the flawed implementation of the Protecting Access to Medicare Act (PAMA) significantly reducing Medicare rates for lab tests, states moving forward with additional Medicaid cuts for testing services will exacerbate an already clear and present threat to patient access.

“ACLA has been a strong and vocal advocate for protecting patient access to lab tests,” said Julie Khani, president of ACLA. “The current reimbursement policies in both Washington, D.C. and now certain states, will pose hardships for patients and for clinical laboratories providing this key healthcare service. Medicaid cuts on top of Medicare cuts target the most vulnerable patient populations in the U.S.  This is not sound policy.”

The letter reads, “We urge you to educate state Medicaid agencies by issuing a State Medicaid Director letter and an Informational Bulletin regarding the recently-implemented PAMA cuts and remind them of their obligation to provide Medicaid reimbursement for laboratory services that is sufficient to ensure access to those services.” It goes on to say, “Patient access to laboratory services is already at risk due to PAMA cuts, especially for vulnerable patients and patients in rural and underserved areas where there are relatively few laboratory providers. Furthermore, those rural providers have a disproportionately larger percentage of Medicare patients than urban providers, which exposes those providers to greater losses as a result of the recent Medicare cuts. These providers not only have to manage Medicare cuts to laboratory reimbursement, but potentially also even deeper Medicaid reimbursement cuts.”

States that base their Medicaid reimbursements for clinical laboratory services on the federal Medicare Clinical Laboratory Fee Schedule (CLFS) are already expected to realize significant savings due to PAMA cuts without taking any action of their own. For example, Missouri which bases its Medicaid rates on the Medicare CLFS is planning cuts 20 percentage points – or an estimated $13.2 million – to its Medicaid reimbursements for lab tests, potentially impacting hundreds of thousands of the state’s beneficiaries who rely on laboratory services to prevent, diagnose, and monitor disease.

Congress enacted PAMA in 2014, which aimed to establish a market-based system for determining lab payment rates. However, CMS instituted a flawed data collection methodology that excluded the vast majority of U.S. laboratories and instead relied on a tiny, non-representative sample to determine rates. As a result, Medicare reimbursements to clinical labs are estimated to be cut by $670 million this year and additional rate reductions scheduled for 2019 and 2020 will slash payments by nearly 30 percent for many tests critical for Medicare beneficiaries.

“Clinical laboratories represent a vital component of the healthcare continuum by targeting diagnoses and helping to guide physician treatment decisions,” said Khani. “Diagnostic innovation is at the forefront of precision medicine and impacting patient care every day.  Reimbursement rates at both the state and federal level should recognize the value of clinical laboratory services and promote patient access – not deter it.”

The ACLA was joined by the American Medical Technologists, the American Society for Clinical Laboratory Services, the American Society for Clinical Pathology, the Association of Public Health Laboratories, the Clinical Laboratory Management Association, the College of American Pathologists, the Medical Group Management Association, the National Association of the Support of Long Term Care, the New York State Clinical Laboratory Association, the New York State Society of Pathologists, the National Independent Laboratory Association and the Point of Care Testing Association.

To read the letter in its entirety, click here.

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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, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.

Policymakers, Patient Advocates, and Clinical Laboratory Leaders Discuss the Future of Clinical Laboratory Testing at ACLA’s 23rd Annual Meeting

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today held its 2018 annual meeting, convening policymakers, patient advocates, payers and industry leaders to discuss the future of clinical laboratory testing. The annual conference, now in its twenty-third year, is the premier meeting in Washington for the clinical lab community that brings national leaders in the diagnostic sector together with lawmakers and administration officials to discuss the latest federal legislative and regulatory policy issues concerning clinical laboratories.

“The ACLA’s annual meeting provides an opportunity for the nation’s leaders in the laboratory sector to discuss pressing issues regarding diagnostics and patient care,” said Julie Khani, President of the ACLA. “We are pleased to lead today’s discussion on the future of diagnostic testing and showcase clinical laboratories’ contributions towards innovative healthcare solutions that drive better outcomes and deliver higher quality patient care.”

Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. delivered remarks at the morning session, preceded by Representative Diana DeGette (D-CO) who opened the meeting with an update on Congress’ healthcare policy priorities. Rep. DeGette serves on the House Energy and Commerce Committee’s Subcommittee on Health and was instrumental in passing the bipartisan 21st Century Cures Act. Together with Rep. Larry Bucshon (R-IN), she is the co-author of the Diagnostic Accuracy and Innovation Act (DAIA) discussion draft which would establish a comprehensive framework for the regulation of diagnostics, including laboratory developed tests and in vitro diagnostics.

Former U.S. Health and Human Services (HHS) Secretary Michael Leavitt delivered the keynote address, lending his insight into the current health policy discussion and what it means for the clinical laboratory sector. The former three-term governor of Utah and cabinet secretary under President George W. Bush shared his experience leading the nation’s health policy agenda as HHS Secretary and offered his thoughts on where the future might be headed. Leavitt is currently the founder and chairman of Leavitt Partners.

ACLA chairman, Curtis Hanson, MD, Chief Medical Officer of Mayo Medical Laboratories, was among the speakers representing the laboratory community, which also included laboratory panelists from DaVita Labs, Quest Diagnostics, ARUP Laboratories, and Sonic Healthcare.  Among panel discussions, representatives from the Centers for Disease Control and Prevention, and the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority, and the Association of Public Health Laboratories discussed the role of clinical laboratories in public health preparedness; while law firms, Alston & Bird LLP and Mintz Levin joined discussions on enforcement and compliance issues. Rounding out the meeting, Medicare contractor and private insurance trends were reviewed by representatives from Aetna, Anthem, Palmetto GBA, the Society for Women’s Health Research and ADVI.

To access the full agenda for ACLA’s annual conference at the Grand Hyatt Hotel, click here.

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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, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.

 

Patient care is put to the test as clinical laboratory services are hit with a one-two punch in rate cuts

From providing vital diagnostic screenings for a wide range of conditions, to playing a pivotal role in precision medicine, clinical laboratories are a crucial component of America’s health system that drive disease prevention and diagnosis and help guide treatment decisions for patient care.

Congress enacted the Protecting Access to Medicare Act (PAMA) of 2014 to protect essential lab services by mandating a reform of the Clinical Laboratory Fee Schedule (CLFS) and establishing a market-based system that encourages innovation and protects patient access to vital clinical lab tests.  Since the passage of PAMA, the American Clinical Laboratory Association (ACLA) has worked closely with CMS and other stakeholders to implement the statute consistent with Congress’s clear intent.

Throughout the multi-year consideration of changes to the CLFS, ACLA and its members agreed with Congress that predictability and rationality in Medicare payments for lab services was necessary. As long as CMS had the proper data and applied the appropriate methodology, the agency would be in a position to establish fair payment based on market rates that would protect ongoing industry innovation and ensure uninterrupted access to the important testing services on which patients rely.

Instead, CMS chose to ignore the clear intent of Congress and the specific commands of the PAMA statute.  Rather than collecting private payor data from the broad laboratory market, including independent, hospital and physician labs, as Congress directed, CMS established data-collection parameters that resulted in the agency collecting data from less than 1 percent of U.S. laboratories. CMS then relied on this tiny, non-representative sample of data to establish payment rates for all laboratories providing care to Medicare beneficiaries.

When it became clear that CMS was not appropriately implementing PAMA’s requirement that the agency collect data from the broad laboratory market, organizations representing labs, hospitals, physicians and others called on CMS to suspend implementation until fundamental flaws could be addressed.  Inexplicably, these stakeholder requests were ignored.

As a result, years of discussion on meaningful payment reform for lab testing that would protect diagnostic innovation and patient access have brought us to this reality: Medicare reimbursement rates to labs providing essential testing services are estimated to drop by $670 million this year, and additional reductions scheduled for 2019 and 2020 will cut payments by nearly 30 percent for many tests critical to caring for Medicare beneficiaries.  For some labs, such as rural hospitals and labs serving patients in skilled nursing facilities – which already have significantly higher operating costs – this could be a death knell that would precede a devastating loss of patient access to necessary testing services. It would also be a devastating loss for local economies. According to a September 2017 analysis, the clinical lab sector contributed over $100 billion to the U.S. economy while sustaining 622,000 jobs nationwide.

Unfortunately, the threat to patient care doesn’t end there. The problem with CMS’s rate cuts stretches beyond Medicare. Since many state Medicaid agencies base reimbursement for labs services on the Medicare schedule, labs are facing further drastic reductions in Medicaid payments. Some state Medicaid programs have moved ahead with additional Medicaid cuts to clinical laboratory tests, resulting in “cuts on top of cuts.” This double hit of rate cuts at both the state and federal level stands to reduce reimbursement to such an extent that access to laboratory testing for some of the most vulnerable in our society is at risk of being seriously compromised.

In response to CMS’ flawed implementation of the data reporting requirements of PAMA, ACLA filed a lawsuit against the U.S. Department of Health & Human Services in December to challenge the unlawful exemption of the vast majority of laboratories required to report private payor data. Additionally, we urge state Medicaid agencies – particularly those that base their reimbursement on Medicare rates – to refrain from making further Medicaid payment reductions to lab services.

An ill-conceived data-collection process, dramatic reductions in Medicare, and a one-two punch rate cut for Medicaid lab services is not the outcome that Congress intended.

We need to reduce barriers to laboratory services and ensure diagnostic innovation continues unabated. To achieve these goals, we need Congress to pass legislation to fix the problems CMS created. If not, those who sought well-intentioned reforms of lab payment rates could instead find themselves delivering a knock-out blow to the promise of innovative diagnostics and long sought personalized care for patients now and in the future.

Julie Khani is the President of the American Clinical Laboratory Association.

Rep. Diana DeGette to Open ACLA 2018 Annual Meeting with a “View from Capitol Hill”

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) announced today that Rep. Diana DeGette (D-CO) will open the organization’s annual meeting on March 6th in Washington, D.C. with an overview of Congress’s 2018 agenda, specifically actions that may impact the clinical laboratory community. A recognized leader in policy impacting diagnostic innovation and its role in precision medicine, DeGette was instrumental in passing the bipartisan 21st Century Cures Act and is the co-author of the Diagnostic Accuracy and Innovation Act (DAIA) discussion draft.

“ACLA is very pleased to have Rep. DeGette open our 2018 annual meeting and address ACLA members and the clinical laboratory community on Congress’s priorities for the year,” said Julie Khani, president of ACLA. “Rep. DeGette has demonstrated strong leadership in advancing comprehensive reform to create a distinct framework for clinical laboratory diagnostics that advances innovation and protects patients, including for both laboratory developed test services (LDTs) and in Vitro diagnostic (IVD) test kits.”

DeGette serves on the House Energy and Commerce Subcommittee on Health. Last year, with Rep. Larry Bucshon (R-IN), she released DAIA, which supports a comprehensive framework for the regulation of clinical laboratory diagnostics. She also is in House Democratic leadership as Chief Deputy Whip.

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 and to register to attend, visit the ACLA annual meeting website, click here.

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.

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FDA Commissioner Scott Gottlieb, M.D. To Address Clinical Laboratory Community at ACLA 2018 Annual Meeting

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) announced today that Food and Drug Administration (FDA) Commissioner Scott Gottlieb, M.D. will deliver remarks at the association’s annual meeting on March 6 in Washington, D.C. 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.

“We are honored to have Dr. Gottlieb participate in our annual meeting. Dr. Gottlieb brings extensive experience from his public sector positions formerly at FDA and the Centers for Medicare and Medicaid Services (CMS) and his clinical perspective as a practicing physician and clinical assistant professor at New York University School of Medicine,” said Julie Khani, president of ACLA. “The clinical laboratory community is looking forward to hearing from Commissioner Gottlieb on agency initiatives.”

Dr. Gottlieb was sworn in as the 23rd Commissioner of the FDA last year under the Trump Administration. Previously, he was appointed by the U.S. Senate to serve on the Federal Health Information Technology Policy Committee and was a Resident Fellow at the American Enterprise Institute.

For more information and to register to attend, visit the ACLA annual meeting website, click here.

ACLA is a not-for-profit association representing the nation’s leading clinical and anatomic pathology laboratories, including national, regional, specialty, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.

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ACLA Submits Comments on Next Generation Sequencing National Coverage Determination

(Washington, D.C.) – The American Clinical Laboratory Association (ACLA) today submitted comments to the Centers for Medicare & Medicaid Services (CMS) on the proposed national coverage determination (NCD), “Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer.”  In its comments, the association expressed support for Foundation Medicine’s original request for a NCD for its comprehensive genomic profiling test, but voiced deep concern with the proposal by CMS to expand the scope of the NCD to all laboratory tests using NGS technology.

“ACLA supports pathways to coverage of molecular diagnostics,” said Julie Khani, president of ACLA.  “However, by creating a de facto requirement that each laboratory test using NGS technology would need approval or clearance as a medical device by the FDA before receiving Medicare coverage, this NCD, if finalized as drafted, could deprive Medicare beneficiaries of currently available laboratory tests.”

ACLA joined other laboratory stakeholders on a letter in December of last year expressing concern with the expanded scope of the proposed NCD and the limited opportunity to provide comments.  While CMS provided an extension, the additional time granted was still insufficient for stakeholder feedback.  ACLA’s comments note:

“Despite the extension of the comment period, stakeholders have not had adequate time to review and understand the full implications of what would be non-coverage for all but a small handful of laboratory tests that use NGS technology – an important factor in the acceleration of personalized medicine.   Finalizing the NCD as proposed effectively would “slam on the brakes” with respect to advances that have allowed clinicians to tailor medical treatment to the individual characteristics of each patient.”

“ACLA does not believe CMS should finalize the proposed NCD as drafted,” said Khani.  “Restricting conditions of coverage for other tests using NGS technology would have a chilling effect on the development of cutting-edge tests using NGS technology, and would deny Medicare beneficiaries access to innovative, medically necessary testing.”

To view ACLA’s comments in their entirety, click here

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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, ESRD, hospital and nursing home laboratories. The clinical laboratory industry employs nearly 277,000 people directly and generates over 115,000 additional jobs in supplier industries. Clinical laboratories are at the forefront of personalized medicine, driving diagnostic innovation and contributing more than $100 billion to the nation’s economy.

 

 

 

 

Group Stakeholder Letter Requesting a Comment Extension on Proposed NGS NCD