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For patient facing mystery illness, the path to a life-changing diagnosis started with a lab test

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For seven years, Cid Lopez suffered from a painful mystery illness. Worst of all, after visiting a number of specialists and undergoing multiple surgeries – including several painful spinal operations and a procedure to remove his gallbladder – he was no closer to identifying his condition.

But everything changed when a sharp-eyed doctor ordered a very specific set of lab tests, unlocking the answers he was looking for. Recently profiled in a Washington Post “Medical Mysteries” piece, Lopez’s story is the latest example of how clinical laboratory diagnostics help patients find the answers they need.

But what actually happens when a patient has a lab test? For Lopez and many other patients, the diagnostic process begins with a visit to a health care provider, often a primary care physician or specialist. In this particular case, his physician suspected a possible fluid imbalance and ordered osmolality and urine tests.

After collecting specimens – blood and urine samples in Lopez’s case – providers send patient specimens to a laboratory staffed by a team of licensed and highly skilled clinical lab professionals. After completing a comprehensive analysis of specimen, the laboratory shares results back with providers.

Guided by the final test results, Lopez’s doctor was able to rule out other conditions and settle on a definitive diagnosis: diabetes insipidus, a rare disorder that causes fluid imbalances in the body. Identifying this unique condition gave Lopez the answers he was looking for and helped zero-in on a personalized treatment plan. After starting a new medication, hormone replacement and a closely monitored diet, Lopez has seen significant improvements in his health that have dramatically increased his quality of life.

Each year, the nation’s 53,000 laboratories conduct billions of reliable, innovative tests to help support early diagnosis, prevention and personalized care for patients like Lopez. To learn more about the life cycle of a lab test, click here.

ACLA Responds to CMS’s Final Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer

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WASHINGTON, D.C.— In response to the Centers for Medicare and Medicaid Services’ (CMS) Final Decision Memo for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced Cancer (CAG-00450R), ACLA President Julie Khani released the following statement:

“We applaud CMS for making important changes to protect Medicare beneficiary access to NGS-based testing for any germline cancer, including breast and ovarian cancer, regardless of stage. Beneficiaries with early-stage cancers deserve access to the medically necessary hereditary testing they need for their health, and CMS’s final coverage decision will help ensure providers have the clinical tools available to intervene early and prevent the progression of cancer for the seniors in their care.

While the final decision includes many meaningful improvements in access for beneficiaries, ACLA was disappointed in the Agency’s decision to limit national coverage to tests that have been FDA-cleared or -approved. However, we are pleased that the Agency has expanded Medicare Administrative Contractor (MAC) discretion to cover germline cancer tests using NGS technology for any cancer diagnosis when certain criteria are met. This flexibility acknowledges the complexity of our rapidly evolving scientific landscape and supports patient access to the vital, groundbreaking diagnostic tools available today as well as future discoveries on the horizon.

ACLA will continue to review the final decision and discuss further implications with our members and peers. We are fully committed to expanding access to accurate and innovative tests for Medicare beneficiaries and look forward to working closely with MACs and CMS to advance this shared goal.”

Last year, ACLA joined 60 leading health care organizations to highlight key challenges facing access to NGS-based testing and to call on CMS to reverse initial guidance that would have placed significant restrictions on NGS-based testing.

To see CMS’s full memo, click here. To see ACLA’s previous comments on the proposed decision memo, 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 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.

ACLA Announces Key Staff Promotions

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WASHINGTON, D.C.—The American Clinical Laboratory Association (ACLA) today announced the promotions of Thomas Sparkman to Senior Vice President of Government Affairs and Policy, and Andrew Young to Senior Coordinator.

“Over the past seven years, Tom has been instrumental in advancing ACLA’s key priorities in front of Congress and the Administration, including recent passage of the Laboratory Access for Beneficiaries (LAB) Act,” said Julie Khani, President of ACLA. “His extensive background in health care and government affairs is a great asset to our members and he will continue to play a key leadership role in this expanded policy position.”

In his new position as Senior Vice President of Government Affairs and Policy, Sparkman will be responsible for leading ACLA’s legislative and advocacy priorities. Prior to joining ACLA in 2013, Sparkman worked as a lobbyist representing numerous biotech and medical device innovators, hospitals and other providers. Previously, Sparkman held positions with the National Association of State Medicaid Directors and the National Association of Chain Drug Stores. Sparkman holds a Bachelor of Pharmacy from Rutgers University, a Master of Public Policy from Georgetown University and a Juris Doctor from American University and is licensed as a pharmacist in the Commonwealth of Virginia and an Associate Member of the Virginia State Bar.

ACLA has also promoted Andrew Young to a new role as Senior Coordinator.

“Since joining ACLA in 2017, Andrew has established himself as an indispensable member of our team,” said Khani. “Many of ACLA’s key projects wouldn’t have been possible without Andrew’s support and dedication, and we look forward to him taking on a greater role across the association.”

In his new position, Young will be responsible for driving key aspects of member engagement and day-to-day operations across the organization. Before joining ACLA, Young was a political consultant on the 2016 campaign trail. Andrew previously served as the Wayne Townsend Legislative Fellow in the office of U.S. Senator Joe Donnelly, where he worked on a range of policy issues, including health care. Young holds a degree in Political Science and a minor in Public and Environmental Affairs from Indiana University.

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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.

Congress Passes The LAB Act, Paving The Way For Future PAMA Reform

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As seniors brace for a new set of cuts to clinical lab services in January, Congress takes decisive action to halt faulty data collection process responsible for year-over-year cuts to Medicare lab benefits

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Independent study will assess how to improve data reporting under PAMA

 

WASHINGTON, D.C. – In a victory for 53 million seniors who depend on clinical laboratory diagnostics for their health, Congress today passed the Laboratory Access for Beneficiaries (LAB) Act, bipartisan legislation to address critical data collection deficiencies resulting in year-over-year cuts to Medicare lab benefits.

The LAB Act paves the way for additional reforms to the 2014 Protecting Access to Medicare Act (PAMA) by delaying the upcoming data reporting period by one year and commissioning a study on how to improve data collection and rate setting to better reflect Congress’ original intent of a market-based fee schedule for clinical laboratory services.

The passage follows a multi-year effort by ACLA and other stakeholders to raise the alarm about the urgent threat facing seniors who rely on lab tests to manage, diagnose and treat disease. Eighty percent of seniors have at least once chronic condition, according to the CDC, and routine monitoring is an essential component of care for this demographic.

While PAMA aimed to protect beneficiary access by establishing a market-based system for determining lab reimbursement rates, the Centers for Medicare and Medicaid Services (CMS) instituted a flawed data collection methodology that excluded information from the vast majority of laboratories and instead relied on a tiny, non-representative sample to determine rates. As a result, reimbursement for key tests that seniors use to manage chronic disease have been drastically cut over the past several years.

The consequences have been severe. According to a survey by the Infectious Disease Society of America (IDSA), over 79% of respondents will be unable to provide the full range of testing needed to rapidly diagnose infectious diseases following the PAMA cuts of 2018 and 2019. In addition, over 32% of respondents have changed their test menus and nearly 40% now refer more tests to another laboratory, which can cause life-threatening delays in diagnosis and care for patients.

“While we join with laboratories and the patients they serve to celebrate today’s victory, we also acknowledge the ongoing harm facing seniors who rely on lab services as a key element of their routine care and who will endure yet another new round of cuts next month,” said ACLA President Julie Khani. “Fortunately, Congress’ decisive action today puts us on the path to enact meaningful PAMA reforms that will protect seniors’ access to essential lab services, as the law originally intended.”

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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.

ACLA Applauds Introduction of the LAB Act in the Senate

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WASHINGTON, D.C. – Ahead of a crucial deadline to safeguard seniors’ access to lifesaving clinical laboratory services, Sen. Richard Burr (R-NC) and Sen. Sherrod Brown (D-OH) introduced the Laboratory Access for Beneficiaries (LAB) Act, bipartisan legislation to address critical data collection deficiencies resulting in year-over-year cuts to Medicare lab benefits.

 

Like its counterpart in the House of Representatives (H.R. 3584), the Senate bill (S. 3049) would delay the upcoming flawed data reporting process that is responsible for millions of seniors losing access to laboratory services.

 

The introduction comes amid a growing chorus of concern about the harm facing Medicare beneficiaries who are highly dependent on routine lab tests for their health. Last week, more than 30 leading health organizations, including the American Clinical Laboratory Association (ACLA), urged congressional leadership to advance the LAB Act as part of “must pass” end-of-the-year legislation to protect seniors from continued erosion of their lab benefits.

 

These ongoing cuts are a direct result of the Centers for Medicare and Medicaid Services (CMS) ignoring congressional direction in implementing the 2014 Protecting Access to Medicare Act (PAMA). The law directed CMS to establish a new market-based system for laboratory reimbursement, yet the agency only collected payment data from less than one percent of the nation’s labs – excluding the overwhelming majority of the market. This unrepresentative sample of laboratory rates consequently resulted in staggering year-over-year cuts to the routine tests that seniors rely on to manage diabetes, heart disease, cancer and countless other chronic conditions.

 

A new round of cuts – informed by incomplete data – is already slated for implementation January 1, 2020. If Congress fails to pass the LAB Act and delay the upcoming data reporting period (January 1 – March 31, 2020) before the end of the year, CMS will undoubtedly repeat the same flawed data collection process. As a result, rates implemented January 2021 will be based on unrepresentative data as well.

 

In addition to suspending the upcoming data reporting period, the LAB Act would also call for a nonpartisan study to provide recommendations on how best to implement a revised data collection process and rate-setting methodology. Together, these core reforms would support a market-based reimbursement system for laboratory services and maintain seniors’ access to vital Medicare benefits, as Congress originally intended.

 

“Make no mistake about it, the faulty implementation of PAMA has resulted in severe consequences for Medicare beneficiaries who depend on clinical laboratory diagnostics to manage, treat and diagnose disease,” said ACLA President Julie Khani. “We’re grateful to Sens. Burr and Brown for introducing the LAB Act and standing up for seniors across the country. It’s vital that we secure access to these lifesaving tests and continue to safeguard seniors’ health.”

 

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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.

 

ACLA Files A Motion for Summary Judgment Against HHS In ACLA v. Azar

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Washington, D.C. — Following a favorable decision on a jurisdictional question issued by the U.S. Court of Appeals for the D.C. Circuit, the American Clinical Laboratory Association (ACLA) has filed a motion for summary judgment before the U.S. District Court for the District of Columbia challenging the flawed implementation of the Protecting Access to Medicare Act (PAMA) in the final rule promulgated by the U.S. Department of Health and Human Services (HHS). ACLA’s motion asks the District Court to strike down HHS’s final rule as unreasonable and contrary to PAMA’s requirements.

ACLA v. Azar returns to the District Court after the U.S. Court of Appeals ruled in favor of ACLA and remanded the case in late July for the District Court to rule on the merits of ACLA’s challenge. To view the decision from the U.S. Court of Appeals, click here.

ACLA’s motion argues that HHS ignored congressional intent and instituted a flawed data collection process in advance of setting rates under PAMA, failing to protect access to laboratory services for Medicare beneficiaries.

The lingering consequences of PAMA’s flawed implementation are severe. As ACLA notes in the motion, “Because the data-collection parameters imposed by the final rule have resulted in the Secretary establishing payment rates that are far below private-sector rates, some laboratories face a serious threat of being forced out of business, others are being forced to scale back essential services, and patients are being deprived of the services they need.”

“We appreciate the District Court’s review of the flawed implementation of PAMA, and the resulting harm to laboratories and the patients they serve,” ACLA President Julie Khani said. “While we continue our advocacy in the courts, it’s even more critical that Congressional leaders advance bipartisan reform and pass the Laboratory Access for Beneficiaries Act, which would delay data reporting for 2020 and provide the necessary time to address the flaws in PAMA that undermine senior’s care.”

To view the original complaint and release, click here. For ACLA’s motion for summary judgment, click here.

ACLA Statement in Response to U.S. Court of Appeals Ruling in ACLA v. Azar

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Court of Appeals Says ACLA is Entitled to Challenge HHS’s Harmful Regulatory Overreach 

Washington, D.C. — In response to today’s ruling from the U.S. Court of Appeals for the District of Columbia in favor of the American Clinical Laboratory Association (ACLA) in its lawsuit against the Department of Health and Human Services (HHS), ACLA President Julie Khani issued the following statement:

“We strongly commend the Court of Appeals’ decision and are very encouraged that it recognizes that ACLA is entitled to challenge the harmful regulatory overreach by the HHS Secretary in his implementation of the Protecting Access to Medicare Act (PAMA). HHS’s continued flawed data collection process poses a direct challenge to the rule of law and PAMA’s intent to support a sustainable, market-based laboratory market for millions of seniors. On behalf of those who have already seen the consequences of this painful overreach, we urge the District Court to act quickly to rule on the merits of ACLA’s case.”

In its brief, ACLA 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 and noted that, “PAMA’s data collection provision…is distinct from its rate-estimation provisions.”

“For data collection, the statute obligates clinical laboratories that participate in the Medicare program to report distinct reimbursement rates they receive from private insurers and requires the Secretary to establish the rules governing that reporting through notice and comment rulemaking. To be sure, the results of that data collection process are used to establish Medicare payment amounts. But the statute’s bifurcated structure supports ACLA’s view that the two provisions and the processes they require are distinct…That the statutory scheme requires private laboratories to report non-Medicare and generally confidential business information (private market rates) to the government on pain of monetary penalties further stands this statutory scheme in sharp contrast to others where the challenged action was found to be intertwined with other agency actions regarding which Congress had barred judicial review.”

The Court’s decision sends the case back to the U.S. District Court for the District of Columbia for review to ensure the Department’s continued regulatory implementation of the law adheres to Congressional intent in establishing clear, market-based parameters for data collection and calculation of rates in accordance with those guidelines.

While ACLA v. Azar continues to be under judicial review, it’s even more critical that Congressional leaders continue to advance bipartisan reforms that would provide a one-year delay of upcoming PAMA reporting activities. The Laboratory Access for Beneficiaries (LAB) Act would suspend data reporting for 2020, providing HHS and Congress the necessary time to address flaws in the current reporting process that continue to undermine seniors’ care.

“While today’s decision is an important moment for millions of beneficiaries, we urge Congressional leaders to immediately halt the data reporting process and allow time to ensure that HHS is implementing PAMA in the right way.”