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Reflecting on #BlackFamCan Week and the aftermath of declines in screenings

July 22, 2021ACLA Blog, ACLA News, All Newslab testing, #BlackFamCan, cancer screenings, PSA testlserio

This summer, the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) launched its inaugural National Black Family Cancer Awareness Week, an important opportunity for all of us to reflect on the devastating impact of cancer on Black families in the United States and the important work we must all do to address ongoing disparities in care.

Black Americans have the highest death rate — and the shortest survival rate — for most cancers, according to the American Cancer Society. Black men also have the highest cancer incidence rate. In addition, Black Americans have twice the incidence of myeloma as white Americans, and recent studies show that Black Americans are significantly less likely to receive the latest treatments, according to the Leukemia and Lymphoma Society.

Unfortunately, these incident rates could be exacerbated by the COVID-19 pandemic, which has led to a significant decline in testing, including cancer screenings. A recent analysis from Braid Forbes Health Research found a 31% drop in cancer testing, on average, across key tests in the first three calendar quarters of 2020 compared to the first three calendar quarters of 2019.

For example, the prostate specific antigen (PSA) test, one of the many important diagnostic tools to identify prostate cancer in its early stages, saw a 16% decrease in 2020. This is particularly concerning given prostate cancer death rates in Black men are more than double those of every other group. Prostate cancer is the second-leading cause of cancer death in Black men, with an estimated 5,350 deaths in 2019, according to the American Cancer Society.

The alarming declines in test volume in 2020 suggest that throughout the COVID-19 pandemic, patients have delayed both routine screenings as well as testing for diagnosis, treatment and management of a variety of medical conditions. This is a chilling trend, because early detection often leads to early intervention, giving patients and providers the best possible chance to beat disease.

Access to routine screening and monitoring remains essential to managing the health of our communities, especially among populations where cancer has a disproportionate impact. As we continue to move forward and recover from this devastating pandemic, medical professionals, policymakers and advocates must work together to raise awareness of the drop in screenings, and support and encourage all patients to get the care they need.

ACLA Statement on Reintroduction of the VALID Act

June 24, 2021Public Health Preparedness and Infrastructure, ACLA News, ACLA Press Releases, Regulatory Issueslserio

Washington, D.C. – Following the reintroduction of the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, ACLA President Julie Khani issued the following statement:

“ACLA is currently reviewing the VALID Act with our members. As the COVID-19 pandemic has illustrated, a clear and nimble regulatory framework with pathways that do not unnecessarily impose regulatory burdens on test development is essential to public health and patient care. To best serve patients, laboratories need clarity and certainty in the regulatory environment. This certainty is critical to encourage innovation and the next generation of breakthrough technologies, and to support continued patient access to accurate and reliable laboratory developed tests necessary to diagnose, monitor and optimize the treatment of disease.

Over the last several years, ACLA has been working closely with policymakers and other stakeholders to advance diagnostic reform for patients. Specifically, ACLA has consistently advocated for three key priorities: 1) risk-based reform that calibrates regulatory controls to the risk posed by the diagnostic test and which applies standards specific to diagnostics, rather than standards developed for medical devices; 2) appropriate grandfathering and transition policies that preserve patient access to currently available laboratory tests, many of which are currently the gold standard in clinical practice; and 3) a transparent and accountable regulatory system, implemented through notice-and-comment rulemaking, that balances the needs of innovation and appropriate regulatory oversight to ensure the accuracy, reliability and access of these tests.

We commend Sen. Michael Bennet (D-CO), Sen. Richard Burr (R-NC), Rep. Diana DeGette (D-CO) and Rep. Larry Bucshon (R-IN), for their continued leadership and attention to this critical issue and look forward to continuing to work together to improve the care available to all Americans.”

Read more: ACLA’s letter to Secretary Becerra on the regulation of Laboratory Developed Tests (LDTs); ACLA’s comments on VALID Act of 2020.

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The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.

ACLA Statement on MedPAC Report

June 15, 2021Saving Access to Laboratory Services Act, ACLA News, All News, ACLA Press Releaseslserio

WASHINGTON, D.C.— Following the release of MedPAC’s June report, ACLA President Julie Khani issued the following statement:

“Recognizing the flawed implementation of the 2014 Protecting Access to Medicare Act (PAMA) and its negative impact on clinical laboratories and the patients we serve, Congress passed legislation in 2019 requiring the Medicare Payment Advisory Commission (MedPAC) to review the methodology the Centers for Medicare and Medicaid Services (CMS) implemented for the private payer-based Clinical Laboratory Fee Schedule (CLFS) rates and report on the least burdensome data collection process that results in a representative sample of all laboratory market segments.

In its report released today, MedPAC found that sampling of private payer rates from independent laboratories, hospital laboratories and physician office laboratories (POLs) is feasible, would produce accurate, representative data while reducing burden and would correct current below-market Medicare rates. This finding validates concerns long expressed by the laboratory community that reimbursement reductions imposed as a result of a flawed data collection process are too extreme and have resulted in unsustainable below-market rates. Importantly, this finding also refutes CMS’s assertion that the inclusion of hospital rates would not materially change Medicare rates.

However, ACLA is deeply concerned with other aspects of MedPAC’s report, which stray outside the clear mandate by Congress and offer biased commentary that ignores the true value of innovative laboratory tests and the importance of robust and timely access for patients. ACLA strongly disagrees with these assertions.

PAMA has set laboratories on an unsustainable path. The first round of data collection resulted in three years of 10 percent annual cuts for the majority of the fee schedule, and with hundreds of tests facing an additional 15 percent cut in 2022, seniors are counting on Congress to enact the necessary reforms to establish a payment system that is truly representative of the market and supports continued innovation and access to critical laboratory services.”

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ACLA Files Notice of Appeal in ACLA v. Becerra

May 28, 2021Saving Access to Laboratory Services Act, ACLA News, Featured News, Reimbursement and Coverage, ACLA Press ReleasesSeniors, Lab Access, Medicare, lawsuit, CMS, PAMA, ACLA v. Azar, ACLA v. Becerra, CLFS, Laboratory Reimbursement, CLIAlserio

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today filed a notice of appeal in its lawsuit against the U.S. Department of Health and Human Services (HHS) challenging the agency’s implementation of the Protecting Access to Medicare Act (PAMA), which requires HHS to establish a market-based data collection process for clinical laboratory diagnostic services.

“In ACLA’s previous appeal, the court ruled that ACLA is indeed entitled to challenge the harmful regulatory overreach by the HHS Secretary in his implementation of PAMA,” said Julie Khani, president of ACLA. “On behalf of the millions of patients we serve, we’ll continue to fight for the opportunity to do so.”

The lawsuit, first filed by ACLA in December 2017, was dismissed in September of 2018 after the U.S. District Court for the District of Columbia concluded that despite the fact that ACLA’s “arguments on the merits raise important questions,” ruling on “the establishment of payment amounts” under PAMA was barred by the statute. In 2019, the U.S. Court of Appeals for the D.C. Circuit overturned that dismissal, sending it back to the lower court “to address in the first instance the merits of petitioner’s arbitrary-and-capricious challenge.” After an extended delay, the federal district court again dismissed the lawsuit on March 30, 2021, relying on the same conclusions that the D.C. Circuit rejected.

“While we continue our advocacy in the courts, it is even more critical for Congress to take legislative action on PAMA reform,” said Khani. “ACLA will continue to work with policymakers to establish a Medicare Clinical Laboratory Fee Schedule that is truly representative of the market and supports continued innovation and access to vital laboratory services, as Congress originally intended. Now is the time to strengthen our laboratory infrastructure and support continued access to the high-quality lab services that seniors depend on.”

To view FAQs on the lawsuit, click here. For additional background on ACLA’s litigation timeline, click here.

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ACLA v. Becerra: Frequently Asked Questions

May 28, 2021Saving Access to Laboratory Services Act, ACLA News, Featured Newslserio

What is ACLA’s response to the court’s recent dismissal of the lawsuit?

On March 30, 2021, the district court for the District of Columbia issued a memorandum opinion and order that for the second time dismissed the lawsuit filed by ACLA. The court’s decision acknowledged that the Court of Appeals for the D.C. Circuit previously determined that ACLA’s case is not precluded by the statutory provision barring judicial review of the “establishment of payment amounts.” It also recognized that the D.C. Circuit remanded the case for the district court “to address in the first instance the merits of [ACLA’s] arbitrary and capricious challenge.” Nonetheless, instead of addressing the merits, the district court dismissed the case as moot, asserting that because of the statutory provision barring judicial review of the “establishment of payment amounts” no live controversy exists between the parties that can be redressed by a favorable judicial decision.

In its previous appeal, ACLA has argued that “Congress precluded judicial review of only ‘the establishment of payment amounts.’ It did not bar review of the Secretary’s final regulations establishing the parameters for collecting confidential data from laboratories.” The Court of Appeals upheld this distinction in July 2019, and noted that, “PAMA’s data collection provision…is distinct from its rate-estimation provisions.” The D.C. Circuit expected the district court on remand to address the merits of ACLA’s claims. Unfortunately, as evidenced by its refusal to hold oral argument and its delay in issuing a decision, the district court failed to give the case the careful consideration it deserves and issued a ruling that is contrary to law. In response, ACLA filed an appeal on May 28, 2021.

Is there still a need for Congress to act?

Yes. Regardless of what happens in the appeal, a legislative solution remains necessary.

ACLA’s lawsuit is about CMS’s implementation of the Protecting Access to Medicare Act (PAMA), a law passed in 2014 to establish a market-based laboratory payment system. Unfortunately, the intent of PAMA was not achieved due to its flawed implementation, which resulted in data reporting from just a small fraction of the laboratory market. This resulted in artificially low Medicare rates for many laboratory services that could ultimately lead to access challenges for patients. ACLA supports the clear direction of Congress to establish a Medicare payment system based on the collection of private payor rates across the wide spectrum of the clinical laboratory community. Therefore, as ACLA continues its advocacy in the courts, the association will continue to work with policymakers to establish a Medicare Clinical Laboratory Fee

Schedule that is truly representative of the market and supports continued innovation and access to vital laboratory services, as Congress intended.

In an acknowledgement of the harm facing seniors, Congress has taken important initial steps to address the impact of PAMA, including the bipartisan passage of the 2019 Laboratory Access for Beneficiaries (LAB) Act and more recently, a delay of ongoing laboratory cuts as part of the 2020 Coronavirus Aid, Relief, and Economic Security (CARES) Act. However, laboratory cuts are scheduled to return in 2022 and could threaten access to testing for seniors and our most vulnerable populations. These cuts will amount to up to 15 percent reductions in reimbursement for certain tests used to diagnose a range of chronic conditions, including heart disease and diabetes. The 2022 cuts are on top of cuts that have already taken place in the last three years (2018, 2019, 2020).

What is the impact of PAMA’s flawed implementation on ACLA members and
Medicare beneficiaries?

Millions of seniors rely on lab tests for their health. Approximately 85 percent of older Americans have at least one chronic health condition, and 60 percent have at least two, according to the CDC. By drastically cutting rates, including for many of the most commonly performed lab tests, access to critical lab services may be threatened, including lab services used to diagnose and treat beneficiaries with a range of chronic conditions, such as heart disease, diabetes and other common health conditions. According to CMS, these routine low-cost tests are facing cuts between 20 and 30 percent – with many tests being cut more than 30 percent. This unsustainable reimbursement model makes it more challenging for some laboratories to provide the testing patients need.

ACLA Applauds New Investments in COVID-19 Testing for the Uninsured

May 25, 2021ACLA News, All News, Featured News, ACLA Press ReleasesFeaturedlserio

WASHINGTON, D.C. – Following today’s announcement by the US Department of Health and Human Services (HHS) that it is dedicating $4.8 billion from the American Rescue Plan (ARP) to support the Health Resources and Services Administration (HRSA) COVID-19 Uninsured Program, ACLA President Julie Khani released the following statement:

“We applaud President Biden and Secretary Becerra for taking decisive action today to protect access to COVID-19 testing for uninsured individuals.

Over the course of this pandemic, uncertainty about coverage and costs has created unnecessary barriers to testing for many patients, including those without health insurance. The actions announced today will help more Americans access the COVID-19 testing they need without hesitation.

Continued access to, and coverage of, high-quality COVID-19 testing remains critically important for all Americans, regardless of insurance status. After performing 125 million PCR tests for COVID-19 to date, ACLA members remain focused on working with the Administration to ensure labs can continue to help meet this challenging moment and deliver the testing our country needs, now and in the future.”

Read more: In letters sent by ACLA to the Biden Administration and to the Senate Finance Committee in February, Julie Khani highlighted the importance of replenishing the uninsured fund.

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ACLA Comments on Medicare Coverage of Innovative Technology (MCIT)

April 6, 2021Comments and Letters, Reimbursement and Coverage, Regulatory Issueslserio

Download (PDF, 600KB)

ACLA Statement on Recent Steps to Expand Testing

March 18, 2021ACLA News, ACLA Press Releaseslserio

Washington, D.C. – Following the announcement of new steps and updated CDC guidelines to ramp up testing and help schools reopen, ACLA President Julie Khani released the following statement:

“Americans are eager to return to work and school, and all accurate and reliable tests have a role in getting us there. We applaud the Biden Administration for taking additional steps to ensure all communities have access to the full range of testing options available.

Clinical laboratories have introduced a range of new tests and techniques to meet widespread patient need, including the development of the at-home specimen collection kits, the expanded use of specimen pooling and multiplex testing, and the launch of serologic testing and novel RNA extraction methods. We remain focused on expanding access to accurate and reliable testing for the patients who are counting on us and stand ready to expand our support in local communities.”

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ACLA Statement on President-elect Biden’s American Rescue Plan

January 14, 2021ACLA News, All News, ACLA Press Releaseslserio

Washington, D.C. – In response to the release of President-elect Biden’s American Rescue Plan, ACLA President Julie Khani released the following statement:

“ACLA members stand ready to support the incoming Biden Administration as they confront the greatest public health threat in a century. President-elect Biden’s plan takes critical and necessary steps to address core challenges that have persisted since the outset of this pandemic.

After performing more than 90 million PCR tests for COVID-19, we remain focused on our efforts to expand access to, and coverage of, accurate and reliable testing for every American.

Meeting the evolving needs of patients nationwide requires significant investment in high precision instruments, adequate testing supplies, a highly trained workforce, modernized reporting systems, cutting edge research and specialized transportation logistics. We remain committed to working with Congress and the incoming Biden Administration to ensure labs can make these investments and increase capacity for the innovative diagnostics our country needs, now and in the future.”

ACLA Statement on Year-End Funding Package

December 21, 2020ACLA News, All News, Featured News, ACLA Press Releaseslserio

WASHINGTON, D.C. – As Congress nears a vote on year-end legislation to fund the government and support COVID-19 response efforts, ACLA President Julie Khani released the following statement:

“This package provides critical support for testing and public health reporting, and takes important steps to protect patients from surprise medical bills. We applaud these landmark health care achievements, which will meaningfully improve health care accessibility for patients throughout the pandemic and beyond it. At the same time, ACLA will be rolling up our sleeves to work with the 117^th Congress, as much work remains to put the COVID-19 crisis behind us. Patients continue to face a patchwork coverage system that drives uncertainty and undermines federal response efforts. ACLA is committed to working with Congress and both the Trump and Biden Administrations to close coverage loopholes and fulfill the promise made in the Families First Act that everyone who needs a COVID test can receive one without worry of costs.

Robust access to accurate and reliable COVID-19 testing remains critical. Even as more Americans get vaccinated in the coming months, we anticipate continued demand for COVID-19 testing through 2021 while we learn more about the vaccines’ effects on transmission rates and continue to monitor community spread.”

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