All posts by Clare Krusing

Reps. Peters, Bilirakis, Pascrell, Schrader, Holding and Hudson Introduce Bipartisan Legislation to Protect Seniors’ Lab Benefits, Improve Data Reporting Under PAMA

LAB Act (H.R. 3584) would delay PAMA reporting period in order to improve data collection process for market-based rates   

WASHINGTON, D.C. — With 53 million Americans facing steep year-over-year cuts to vital clinical diagnostics, the American Clinical Laboratory Association (ACLA), AdvaMed, the National Independent Laboratory Association (NILA) and the Point of Care Testing Association applaud new bipartisan legislation introduced to address a flawed data collection process that continues to erode Medicare lab benefits for the country’s most vulnerable seniors.

In 2014, Congress passed the Protecting Access to Medicare Act (PAMA) to ensure millions of seniors could maintain access to critical health services, including laboratory tests. As part of PAMA implementation, Congress directed the HHS Secretary to establish market-based rates for clinical laboratories; however, the Secretary deliberately disregarded Congress’ instruction and cherry-picked payment data from less than 1% of laboratories nationwide.

As a result, millions of Medicare beneficiaries who are highly dependent on routine lab tests for their health may lose access to these important tests as laboratories cannot provide these services in the face of unsustainable cuts of more than 30 percent across a range of diagnostic tests. Absent immediate Congressional action, HHS is set to repeat the same flawed process to set reimbursement rates again in 2020, posing a direct threat to seniors’ access to essential medical care for diabetes and other chronic conditions.

The Laboratory Access for Beneficiaries (LAB) Act, introduced by Rep. Scott Peters (D-CA), Rep. Gus Bilirakis (R-FL), Rep. Bill Pascrell (D-NJ), Rep. Kurt Schrader (D-OR), Rep. Richard Hudson (R-NC) and Rep. George Holding (R-NC), would delay the next round of data reporting by one year to ensure that all applicable laboratories required to report private payor data have the necessary time to do so. The bill also calls for the National Academy of Medicine to provide recommendations to Congress on less burdensome data collection methods and representative reimbursement rate calculations that result in the reliable, sustainable, market-based system originally intended by Congress.

“Our most vulnerable seniors are at the whim of a flawed data collection and reporting process that is fundamentally at odds with the quality care they deserve. They have seen the impact of PAMA’s misguided implementation already – laboratory closures, reduced test menus and longer wait times for care,” Julie Khani, ACLA President, said. “The LAB Act is a meaningful step forward to achieving comprehensive PAMA reform for clinical laboratory services. We applaud Reps. Peters, Bilirakis, Pascrell, Schrader, Hudson and Holding for their leadership in protecting Medicare beneficiaries and urge Congress to prioritize the LAB Act before seniors face another round of cuts.”

“It is imperative that Medicare beneficiaries continue to have access to life-saving clinical diagnostic laboratory tests. Unfortunately, Section 216 of PAMA established a deeply flawed framework that jeopardizes this access,” Susan Van Meter, Executive Director at AdvaMedDx, said. “The recently-introduced LAB Act is an important first step to improving the current rate setting process and ensuring market-based reimbursement rates for clinical laboratories, so that millions of Medicare beneficiaries can receive the medical care they need. We thank Reps. Bill Pascrell (D-NJ), Gus Bilirakis (R-FL), Scott Peters (D-CA), Kurt Schrader (D-OR), Richard Hudson (R-NC) and George Holding (R-NC) for their commitment to American patients, and we look forward to working with them to see the bill become law.”

“NILA is encouraged to see Reps. Pascrell, Bilirakis, Peters, Schrader, Hudson and Holding introduce legislation that acknowledges the flaws in the PAMA data collection process and we look forward to working with the National Academy of Medicine to analyze the process to develop a better system that will ensure the data accurately reflects the entire laboratory market,” Mark Birenbaum, PhD, Executive Director, NILA said. “We look forward to working with Congress to see this new system is put in place as quickly as possible so that patients continue to have access to essential laboratory tests.”

To view the LAB Act, click here.

CDC, Private Sector Laboratory Partners Build on Cross-Sector Collaboration Related to Emergency Preparation & Response

ATLANTA, G.A. – The Centers for Disease Control and Prevention (CDC) led a tabletop exercise with multiple partners to strengthen diagnostic laboratory surge testing capacity during an emergency response.

The purpose of the exercise was to assess the utility of a newly created CDC Emergency Operations Center (EOC) Laboratory Task Force Guide, and to review the processes for commercial clinical laboratories to provide diagnostic surge testing during a public health emergency.

Four priority areas were identified for further work that include establishing a process for communication with critical partners during a response; helping laboratories to prepare for emerging pathogens through proper use of risk assessments; continuing work to improve how emergency tests are implemented into the healthcare system; and better integrating epidemiology and laboratory data before it is reported to CDC.

During previous public health emergencies, including the Zika outbreak in 2016, CDC and public health organizations engaged commercial laboratories to meet the urgent demand for diagnostic tests when public health laboratories reached testing capacity. In response to these events, CDC and the American Clinical Laboratory Association (ACLA) established a memorandum of understanding (MOU) to support coordination between private industry and public health agencies as part of a system-wide response plan to address future public health emergencies.

“Infectious disease outbreaks and other public health emergencies present significant, often unpredictable challenges to the health system, making preparedness essential,” said Jasmine Chaitram, Associate Director of Laboratory Preparedness from CDC’s Division of Laboratory Systems. “The need for additional laboratory diagnostic surge testing capacity during major outbreaks has demonstrated the importance of formal partnerships with commercial laboratories that can help meet testing demands.”

The exercise focused on strengthening response and coordination among public and private sector partners, and local epidemiologists, including early notification procedures, technical assistance, logistical support, safe practices and results reporting.

Leaders from the clinical laboratory industry, who raised concerns about the previous Zika and Ebola outbreaks, praised the tabletop exercise as an important step forward.

“When an outbreak occurs, clinical laboratory diagnostics are on the frontline of emergency response,” said Julie Khani, president of the American Clinical Laboratory Association, the trade association that represents commercial laboratories. “We applaud the CDC for their proactive engagement and for hosting this important exercise, and we look forward to working with them to improve preparedness and response.”

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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.

New analysis challenges GAO Report’s assumptions on lab billing

A new analysis from Braid-Forbes Health Research exposes the Government Accountability Office’s (GAO) flawed assumptions about lab billing practices by presenting survey data on more than 20 million actual clinical laboratory claims.

Braid-Forbes’ analysis of publicly available data demonstrates that the GAO’s claim – that labs are receiving “excess payments” by charging Medicare for individual component tests in greater numbers rather than charging reduced rates for a test panel – is flat out wrong.

In order for the GAO’s “unbundling” assumption to be true, the volume of organ and disease panel tests – such as the comprehensive metabolic panel – billed to Medicare should have decreased and in turn the volume for all of the individual component tests that make up organ and disease panels should have skyrocketed. Instead, analysis of Medicare data show that volume for both the comprehensive metabolic panel and its individual component tests have fallen on average. Comparing the first two quarters of both 2017 (pre-PAMA) and 2018 (post-PAMA), shows the comprehensive metabolic panel’s Medicare volume dropped by 2%, and the individual component tests also decreased  volume by an average of 5%, disproving the GAO’s hypothetical claim of widespread inappropriate billing by labs and overpayments by the Medicare program.

Since the report was first released in November 2018, other industry leaders and stakeholders have raised questions about the GAO’s puzzling conclusions. In response, the GAO has conceded that the assumptions used to draw their conclusions were not based on real lab practices. In a recent interview, GAO director of healthcare, James Cosgrove admitted, “We weren’t analyzing what labs are or aren’t doing. We were analyzing what the exposure to Medicare would be.”

Given that the GAO’s analysis was not grounded in real analysis of actual lab practices and that the full consequences of PAMA harm have yet to be honestly evaluated, Congress should delay PAMA data reporting for one year. Doing so would allow time for a more representative share of labs to report private market data and provide valuable time for stakeholders and policymakers to determine how to reform PAMA, ensuring a truly market-based system that will protect Medicare beneficiaries’ laboratory access.

GAO acknowledges recent report projected lab spending based on hypothetical framework

The U.S. Government Accountability Office (GAO), often referred to as the “congressional watchdog,” is supposed to examine how taxpayer dollars are spent, and then provide Congress and federal agencies with objective, reliable information to help save money and work efficiently. And yet, following growing pushback to a recent report on laboratory billing practices in the Medicare program, James Cosgrove, GAO health care director and author of the report, shared that the GAO’s findings are not actually reflective of current industry practice – but rather are based on a hypothetical scenario.

“We weren’t analyzing what labs are or aren’t doing,” Cosgrove said. “We were analyzing what the exposure to Medicare would be.”

In November of last year, the GAO released a report on the Centers for Medicare & Medicaid Services’ (CMS) implementation of new laboratory payment rates under PAMA. As part of its report, the GAO was supposed to analyze 2016 Medicare claims data and assess the future financial impact of the implementation of PAMA – which aims to establish a market-based payment system for lab tests – on CMS.

The report claims that Medicare costs could increase by as much as $10.3 billion by 2020 due to the unbundling of certain laboratory panel tests. This accusation, however, is based entirely on a fundamental misunderstanding of how labs bill and are reimbursed for panel testing and suggests that labs are receiving “excess payments” by no longer charging Medicare reduced rates for bundled tests – a claim that is inaccurate and unfounded.

In reality and according to standard industry practices, clinical laboratories are required to bill Medicare for panel tests according to guidelines outlined by the American Medical Association (AMA) CPT codes. Recent survey data of more than 20 million claims for the comprehensive metabolic panel found that labs consistently billed panel tests as required.

Rather than acknowledge the practices currently carried out by the vast majority of labs across the country, the GAO concocted a hypothetical scenario that suggests labs are unbundling certain panel tests and receiving larger reimbursements for individual tests. This assumption is grossly inaccurate and runs counter to standard, demonstrated industry practice.

James Cosgrove went on to say, “It’s not about what the lab industry was or wasn’t doing. It’s about the need to have controls in place.”

It’s clear that the GAO overlooked standard industry practices and instead concocted hypothetical scenarios to inform its recommendations and conclusions. In the process, the report neglects the dangers that CMS’ year-over-year cuts pose to the clinical laboratory industry and the patients they serve.

ACLA Statement on New Genetic Testing Guidelines for Hereditary Breast Cancer

New guidelines issued by the American Society of Breast Surgeons call for genetic testing to be available for all breast cancer patients

Washington, D.C. – In response to the American Society of Breast Surgeons’ (ASBrS) recently released guidelines on genetic testing for hereditary breast cancer, ACLA President Julie Khani issued the following statement:

“Our ability to pinpoint the start of breast cancer at its earliest stages – or before it even develops – represents a major inflection point in the treatment and care for countless patients and their family members. Through groundbreaking diagnostic lab tests and following recommended guidelines for screening and monitoring, we can make significant progress in preventing and treating breast cancer before it’s able to progress.”

Today, because of innovations in testing and technology, 62% of breast cancer cases are diagnosed before the cancer spreads outside the breast, according to recent data. In cases where cancer is identified at this early stage (where there is no sign that the cancer has spread outside of the breast), the 5-year rate of survival is 99%.

As the new testing guidelines note, patients already diagnosed with breast cancer can also glean important results from genetic tests, including determining the best course of treatment.

Specifically, the new American Society of Breast Surgeons guidelines on genetic testing outline five key recommendations:

  • Breast surgeons, genetic counselors, and other medical professionals knowledgeable in genetic testing can provide patient education and counseling and make recommendations to their patients regarding genetic testing and arrange testing.
  • Genetic testing should be made available to all patients with a personal history of breast cancer.
  • Patients who had genetic testing previously may benefit from updated testing.
  • Genetic testing should be made available to patients without a history of breast cancer who meet NCCN guidelines
  • Variants of uncertain significance are DNA sequences that are NOT clinically actionable. This type of result needs to be considered as inconclusive, and the patient should be managed based on their risk factors and not influenced by this result.

To view the new American Society of Breast Surgeons guidelines on genetic testing for hereditary breast cancer, 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, hospital, ESRD 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.

Leading a new generation of personalized medicine, LDTs must be key consideration in diagnostic reform

Lab developed tests (LDTs) are essential to health care delivery and the broader health system, helping pave the way for a new era of personalized medicine and making it possible to achieve national health goals like the Cancer Moonshot.

These vital tests are developed and performed by individual laboratories, providing reliable, early diagnosis for many rare and increasingly complex conditions. In many cases, LDTs are born from gaps in clinical needs.

Genomic testing only a few years ago was limited to patients with certain solid tumors (e.g. melanoma, lung cancer, and colon cancer). Today, targeted tumor-sequencing tests can be used for any tumor – regardless of where in the body the cancer started. This technology has the ability to screen hundreds of genes for cancer tumors in an unprecedented way, allowing providers to assess whether a tumor is susceptible or responsive to certain drugs. As a result, genomic testing guides better treatment or prevention options for patients when they first need it, avoiding trial and error to identify the best course of action.

Diagnostic science, technology, and innovation have advanced to a tipping point, but government oversight enacted decades ago has struggled to keep up. Instead of providing clear guardrails to innovators and assured paths for patient access, federal and state laws have begun to overlap and create unnecessary burdens, duplication, and even confusion. This overlap and confusion threatens to stifle continued medical diagnostic progress.

To ensure that high-quality, accurate, reliable, and innovative tests are reaching the patients who need them, the time has come for Congress to prioritize comprehensive reform to federal diagnostic oversight and support cutting-edge innovations that both patients and the health system depend on. Furthermore, Congress must undertake reforms such that any new diagnostic framework acknowledges the unique function, value, and workflow of LDTs. These highly-tailored tests continuously respond to emerging gaps in clinical care and cannot be regulated with a one-size fits all approach.

The good news is that Congress has already begun work to advance these reforms.  Leaders in Congress, particularly Rep. Diana DeGette (D-CO) and Rep. Larry Bucshon (R-IN), along with Sen. Michael Bennet (D-CO) and retired Sen. Orrin Hatch (R-UT), have been honing legislative proposals in collaboration with stakeholders and the Administration, beginning with the Diagnostic Accuracy and Innovation Act (DAIA), and more recently, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act.  Much work remains, however.

ACLA believes that reform must ultimately create a modernized, risk-based model for federal review that accounts for the full range of tests and diagnostics coming to market. Reform should also establish clear, objective standards and grandfathering provisions to guarantee patients can continue to access the life-saving tests they need during transitions to a new regulatory framework. These key provisions will help ensure both continued innovation and robust patient access to high-quality, accurate, and reliable clinical laboratory diagnostics.

As we move forward in 2019, Congress should build on the important work led by Rep. DeGette, Rep. Bucshon, Sen. Bennet and Sen. Hatch. We must advance meaningful and comprehensive solutions to bring the next generation of clinical innovation to patients. For the millions of patients and their families, it’s imperative that we get this right.

Seniors managing diabetes are counting on Congress to protect their essential lab services

For America’s seniors, diabetes is now the number one health condition leading to frequent emergency room visits, according to a recent study in the Annals of Internal Medicine. On top of that staggering statistic, the CDC reports that one in four seniors has diabetes—the highest prevalence among any age group.

Most patients know that disease monitoring and management requires reliable access to routine testing. Clinical laboratory diagnostics are essential tools that seniors use to navigate a number of health challenges, including diabetes, heart disease, liver disease, kidney disease, prostate and colon cancers, anemia, infections, and opioid dependency. As with all diseases, early detection and consistent management of diabetes means that patients and doctors have opportunities to achieve better health outcomes – a victory for both patients and the broader health system.

“This study shows that there are opportunities for both cost savings and more targeted interventions to help improve outcomes for seniors in the emergency department, where they often experience the health care system,” said Kelly J. Ko, PhD, who co-authored the recent study on seniors’ ER use, and also serves as Director of Clinical Research at the West Health Institute.

For the 12 million seniors struggling to manage their diabetes and reduce complications, reliable access to appropriate lab tests makes all the difference. In the new Congress, lawmakers have an opportunity to address the root causes of diabetes complications—and many other chronic health conditions facing seniors—by protecting access to essential lab services.

Many seniors who rely on tests to manage chronic diseases may face restricted access to testing in the future due to drastic cuts to Medicare reimbursement, a result of the failed implementation of the Protecting Access to Medicare Act (PAMA). In 2014, Congress passed PAMA to safeguard Medicare beneficiaries’ access to vital health services, including laboratory tests. Unfortunately, the U.S. Department of Health and Human Services (HHS) took a flawed and misguided approach to PAMA implementation, resulting in year-over-year slashes to Medicare reimbursement for lab tests. In fact, some of the most common tests that seniors use to treat and diagnose diabetes – like glycosylated hemoglobin tests, microalbumin quantitative tests, and assay of urine creatinine tests – will suffer reimbursement rate cuts of more than 34%. (Read more about PAMA’s impacts on our website).

Ultimately, slashing reimbursement rates will threaten seniors’ access to lab tests and will likely mean more trips to the hospital for patients struggling to manage chronic conditions like diabetes. For lawmakers, protecting access to seniors’ lab tests is an important mission with rare bipartisan support. These harmful PAMA cuts are a real and urgent threat worthy of immediate Congressional attention.

More than 60 Leading Health Care Organizations Call on CMS to Maintain Coverage for Medically Necessary Cancer Testing

Overly broad interpretation of national coverage determination for next generation sequencing restricts Medicare beneficiary access to vital testing and adversely impacts cancer care

 WASHINGTON, DC – February 1, 2019 – Leading health care companies and organizations representing patients, providers, academic medical centers, laboratories, and diagnostic manufacturers urged the Centers for Medicare and Medicaid Services (CMS) to revise its interpretation of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS). In a letter to CMS Administrator Seema Verma, 63 organizations expressed serious concerns that the overly broad interpretation will restrict patient access to medically necessary and relevant clinical tests and adversely impact cancer care and outcomes.

CMS’ latest guidance directly undermines beneficiaries’ coverage as finalized in last year’s NCD. NGS-based testing is now the standard of care for cancer patients, and the current interpretation implies NGS-based testing will become non-covered for many Medicare beneficiaries. This has a direct result on beneficiaries’ access and coverage to essential testing that can make a fundamental difference in their treatment.

In particular, those with early-stage cancer who may have a genetic predisposition based on family history or other acceptable criteria will not be eligible for testing using NGS-based methods. Restricting patients with early-stage cancers from accessing hereditary testing may lead to poorer outcomes as they are not receiving optimal therapy based on their genetic status.

“It is essential that CMS unequivocally maintain coverage for medically necessary NGS-based tests. Imposing broad restrictions on standard of care testing will have serious consequences for Medicare beneficiaries and negatively impact their care,” said Julie Khani, President of the American Clinical Laboratory Association.

“CMS’ interpretation of the NGS NCD contradicts and reverses previously established policies. The NCD supersedes existing local coverage determinations that provide crucial coverage of NGS-based genetic testing for mutations associated with inherited cancer syndromes—like BRCA mutations and Lynch syndrome—in patients without advanced cancer,” said Sue Friedman, Executive Director of FORCE: Facing Our Risk of Cancer Empowered. “This action will harm patients! We are extremely disappointed that there was never an opportunity for patient advocacy groups to formally comment or discuss the implementation of this policy and frustrated that these medically necessary tests are now not eligible for Medicare coverage.”

“AMP is committed to working with key stakeholders to preserve broad patient access to the thousands of clinically- and analytically-validated NGS-based testing for cancer and other conditions that benefit patients each and every day,” said Mary Steele Williams, Executive Director of Association for Molecular Pathology. “Rather than creating additional barriers, we urge CMS to consider the collective comments from this diverse community of health care organizations and reinstate coverage for these medically necessary hereditary cancer tests. Without precision diagnostics, there is no precision medicine.”

To view the full letter and list of undersigned organizations, please visit www.amp.org/NGSNCDLetter.

 

ABOUT ACLA

The American Clinical Laboratory Association (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 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. For more information, visit www.acla.com. Media contact: Clare Krusing, ckrusing@reservoircg.com.

About FORCE 

No one should have to face hereditary breast, ovarian and related cancers alone. Facing Our Risk of Cancer Empowered (FORCE) is the voice of the hereditary cancer community, providing support, education and awareness to help those facing hereditary breast, ovarian and related cancers know their healthcare options and make informed decisions. The organization is the de facto leader in guiding critical research and policy issues that impact the hereditary cancer community. For more information about FORCE and hereditary cancers, please visit www.facingourrisk.org. Media contact: Lisa Schlager, lisas@facingourrisk.org.

ABOUT AMP

The Association for Molecular Pathology (AMP) was founded in 1995 to provide structure and leadership to the emerging field of molecular diagnostics. AMP’s 2,500+ members practice in the various disciplines of molecular diagnostics, including bioinformatics, infectious diseases, inherited conditions, and oncology. They include individuals from academic and community medical centers, government, and industry; including pathologist and doctoral scientist laboratory directors; basic and translational scientists; technologists; and trainees. Through the efforts of its Board of Directors, Committees, Working Groups, and members, AMP is the primary resource for expertise, education, and collaboration in one of the fastest growing fields in healthcare. AMP members influence policy and regulation on the national and international levels, ultimately serving to advance innovation in the field and protect patient access to high quality, appropriate testing. For more information, visit www.amp.org. Follow AMP on Twitter: @AMPath. Media contact: Andrew Noble, anoble@amp.org.

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