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Clinical Laboratories and Pathology Groups

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Congress Holds Off on Enabling FDA Regulation of Clinical Laboratory-Developed Tests

Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage

In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs).

But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate committees urging passage of legislation that would enable some regulation of LDTs, the VALID Act was ultimately omitted from the year-end omnibus spending bill (H.R. 2617).

That may be due to pressure from organizations representing clinical laboratories and pathologists which lobbied hard against the bill.

The American Association for Clinical Chemistry (AACC), American Society for Clinical Pathology (ASCP), Association for Molecular Pathology (AMP), Association for Pathology Informatics, and Association of Pathology Chairs were among many signatories on a May 22 letter to leaders of the US Senate Committee on Health, Education, Labor and Pensions that described the bill as “very flawed, problematic legislation.”

The Association of American Medical Colleges (AAMC) also signed the letter, as did numerous medical laboratories and health systems, as well as the American Society of Hematology and the Clinical Immunology Society.

Emily Volk, MD

Responding to criticism of its stance on FDA oversight of LDTs, in a May 2022 open letter posted on the organization’s website, anatomic pathologist and CAP president Emily Volk, MD, said “we at the CAP have an honest difference of opinion with some other respected laboratory organizations. … We believe the VALID Act is the only viable piece of legislation addressing the LDT issue. … the VALID Act contains many provisions that are similar to policy the CAP has advocated for regarding the regulation of laboratory tests since 2009. Importantly, the current version includes explicit protections for pathologists and our ability to practice medicine without infringement from the Food and Drug Administration (FDA).” (Photo copyright: College of American Pathologists.)

Organizations on Both Sides Brought Pressure to Bear on Legislators

“University laboratories and their representatives in Washington put on a full-court press against this,” Rep. Larry Bucshon, MD, (R-Indiana) told ProPublica. Bucshon, who is also a cardiothoracic surgeon, co-sponsored the VALID Act along with Rep. Diana DeGette (D-Colorado).

The AAMC and AMP were especially influential, Bucshon told ProPublica. In addition to spending hefty sums on lobbying, AMP urged its members to contact legislators directly and provided talking points, ProPublica reported.

“The academic medical centers and big medical centers are in every state,” Bucshon said. As major employers in many locales, they have “a pretty big voice,” he added.

CAP, on the other hand, was joined in its efforts by AdvaMed, a trade association for medical technology companies, the American Cancer Society Cancer Action Network, Association for Clinical Oncology (ASCO), Association of Black Cardiologists, Friends of Cancer Research, Heart Valve Voice US, LUNGevity Foundation, and The Pew Charitable Trusts.

Discussing CAP’s reasoning behind its support of the VALID Act in a May 26 open letter and podcast, CAP president Emily Volk, MD, said the Valid Act “creates a risk-based system of oversight utilizing three tiers—low, moderate and high risk—in order to target the attention of the FDA oversight.”

While acknowledging that it had room for improvement, she lauded the bill’s three-tier risk-based system, in which tests deemed to have the greatest risks would receive the highest level of scrutiny.

She also noted that the bill exempts existing LDTs from an FDA premarket review “unless there is a safety concern for patients.” It would also exempt “low-volume tests, modified tests, manual interpretation tests, and humanitarian tests,” she wrote.

In addition, the bill would “direct the FDA not to create regulations that are duplicative of regulation under CLIA,” she noted, and “would require the FDA to conduct public hearings on LDT oversight.”

Pros and Cons of the VALID Act

One concern raised by opponents relates to how the VALID Act addressed user fees paid by clinical laboratories to fund FDA compliance activities. But Volk wrote that any specific fees “would need to be approved by Congress in a future FDA user fee authorization bill after years of public input.”

During the May 2022 podcast, Volk also cast CAP’s support as a matter of recognizing political realities.

“We understand that support for FDA oversight of laboratory-developed tests or IVCTs is present on both sides of the aisle and in both houses of Congress,” she said. “In fact, it enjoys wide support among very influential patient advocacy groups.” These groups “are very sophisticated in their understanding of the issues with laboratory-developed tests, and they do have the ear of Congress. There are many in the laboratory community that believe the VALID Act goes too far, but I can tell you that many of these patient groups don’t believe it goes far enough and are actively pushing for even more restrictive paradigms.”

Also urging passage of the bill were former FDA commissioners Scott Gottlieb, MD, and Mark B. McClellan, MD, PhD. In a Dec. 5 opinion piece for STAT, they noted that “diagnostic technologies have undergone considerable advances in recent decades, owing to innovation in fields like genomics, proteomics, and data science.” However, they wrote, laws governing FDA oversight “have not kept pace,” placing the agency in a position of regulating tests based on where they are made—in a medical laboratory or by a manufacturer—instead of their “distinctive complexity or potential risks.”

In their May 22 letter, opponents of the legislation outlined broad areas of concern. They contended that it would create “an onerous and complex system that would radically alter the way that laboratory testing is regulated to the detriment of patient care.” And even though existing tests would be largely exempted from oversight, “the utility of these tests would diminish over time as the VALID Act puts overly restrictive constraints on how they can be modified.”

CLIA Regulation of LDTs also Under Scrutiny

The provision to avoid duplication with the Clinical Laboratory Improvement Amendments (CLIA) program—which currently has some regulatory oversight of LDTs and IVCTs—is “insufficient,” opponents added, “especially when other aspects of the legislation call for requirements and activities that lead to duplicative and unnecessary regulatory burden.”

Opponents to the VALID Act also argued that the definitions of high-, medium-, and low-risk test categories lacked clarity, stating that “the newly created definition of moderate risk appears to overlap with the definition of high risk.”

The opponents also took issue with the degree of discretion that the bill grants to the US Secretary of Health and Human Services. This will create “an unpredictable regulatory process and ambiguities in the significance of the policy,” they wrote, while urging the Senate committee to “narrow the discretion so that stakeholders may better evaluate and understand the implications of this legislation.”

Decades ago, clinical laboratory researchers were allowed to develop assays in tandem with clinicians that were intended to provide accurate diagnoses, earlier detection of disease, and help guide selection of therapies. Since the 1990s, however, an industry of investor-funded laboratory companies have brought proprietary LDTs to the national market. Many recognize that this falls outside the government’s original intent for encouragement of laboratory-developed tests to begin with.

—Stephen Beale

Related Information:

The Tests Are Vital. But Congress Decided That Regulation Is Not.

Message from the CAP President on the VALID Act

Better Lab Test Standards Can Ensure Precision Medicine Is Truly Precise

Healthcare Groups Urge Congress to Pass Diagnostic Testing Reform Before Year’s End

Califf: FDA May Use Rulemaking for Diagnostics Reform If VALID Isn’t Passed

Is FDA LDT Surveillance Set to Improve as VALID Act Heads to Resolution?

Congress Needs to Update FDA’s Ability to Regulate Diagnostic Tests, Cosmetics

FDA User Fee Reauthorization: Contextualizing the VALID Act

They Trusted Their Prenatal Test. They Didn’t Know the Industry Is an Unregulated “Wild West.”

InsideHealthPolicy: Pew, AdvaMed, Others Push for VALID as Clock Ticks on Government Funding

AdvaMed Leads Letter Urging Lawmakers to Support Bipartisan Diagnostics Reform

LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

Survey respondents can give their opinions about the proposed VALID and VITAL acts

Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written.

An LDT is a proprietary diagnostic test developed and performed by an individual medical laboratory. In academic center laboratories, LDTs often are created to address an unmet clinical need. Currently, LDTs are primarily regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

That existing regulatory arrangement will change if one of the two pending bills in Congress were to pass and be signed into law. That proposal is known as the Verifying Accurate Leading-Edge IVCT Development Act, or VALID Act. It is a bipartisan, 245-page bill that proposes FDA oversight of LDTs and is making its way through both the Senate and the House of Representatives.

A smaller, seven-page counterproposal is also before the Senate called the Verified Innovative Testing in American Laboratories Act, or VITAL Act. The VITAL Act would keep LDTs under CLIA but mandate updates to CLIA’s rules to account for modern tests.

Readers: Are you in favor of more or less regulation of LDTs? Take this quick survey and let us know what you think.
Dark Daily wants to know your thoughts about LDT oversight. Click here to take our six-question survey. Results of this survey will be reported in a coming Dark Daily e-briefing.

Alert pathologists and clinical laboratory managers know that behind every bill proposed in Congress is a party with a vested interest that brought the issue to a senator or representative. Once enacted into law, a new bill changes the status quo, generally to the benefit of the private interests that requested that bill. This is true of both the VALID Act and the VITAL Act.

The table at the bottom of this briefing compares the provisions of each act and is current as of March 28.

Who Opposes VALID Act?

The VALID Act is garnering more attention than the VITAL Act.

On March 22, the American Association for Clinical Chemistry (AACC) sent out an email message urging its members to oppose the VALID Act.

“Let your legislators know that that if VALID becomes law, your institution and other hospitals and small commercial laboratories could be forced to stop providing LDTs,” wrote Patricia Jones, PhD, DABCC, FACB, Chair of AACC’s Policy and External Affairs Core Committee. The AACC has long criticized the VALID Act..

The Association for Molecular Pathology also opposes the VALID Act, and the Coalition for Innovative Laboratory Testing—an alliance of labs and scientists formed in early 2021—has created a website against the proposed law.

Who Supports the VALID Act?

On the other side of the debate, Philadelphia-based The Pew Charitable Trusts, a nonprofit that in part analyzes publics policy, has come out in support of the VALID Act’s proposed requirements.

Two bills are pending in Congress about the future of LDT regulation.

“Although the [current] LDT regulatory process offers labs significant flexibility and enables a more rapid response to public health needs when no FDA-cleared or -approved test exists, the relative lack of oversight for LDTs puts the health of patients at risk,” Pew wrote in an October 2021 report on LDTs.

The Advanced Medical Technology Association also supports the VALID Act, as do many manufacturers of in vitro test kits and large commercial labs. Proponents also believe FDA regulation is needed for IVCTs because they are similar to medical devices and bring with them patient safety concerns.

The American Clinical Laboratory Association and the National Independent Laboratory Association (NILA) have not taken formal positions on the VALID Act.

Congress Could Roll VALID Act into MDUFA Vote to Win Passage

There may be an effort to attach the VALID Act to the authorization vote for the Medical Device User Fee Agreement V (MDUFA), according to a February health legislation alert from law firm Akin Gump Strauss Hauer & Feld based in Washington.

MDUFA funding provides resources to the FDA’s medical device review program. Congress is set to receive final MDUFA V recommendations in April.

Nineteen healthcare and lab industry groups, including the American Medical Association, AACC, AMP, and NILA, sent a joint letter to four Congress members on Feb. 23 requesting they deliberate the VALID Act separately and not as part of MDUFA.

Again, please complete this survey and tell us what you think about FDA regulation of LDTs, as defined in the VALID Act, compared to continuing LDT oversight via a modernized CLIA in the VITAL Act.

—Scott Wallask

Comparison of VALID Act and VITAL Act

Full act nameVerifying Accurate Leading-Edge IVCT Development ActVerified Innovative Testing in American Laboratories Act
Bill numbersHouse Bill H.R.4128
Senate Bill S.2209
Senate Bill S.1666
SponsorsSen. Michael Bennet (D-CO) , Sen. Mike Braun (R-IN), Rep. Larry Bucshon, MD (R-IN), Sen. Richard Burr (R-NC), and Rep. Diana DeGette (D-CO)Sen. Rand Paul (R-KY)
ProvisionsDevelopers shall apply for premarket approval of IVCTs if there is insufficient evidence of analytical validity or clinical validity or if it’s reasonably possible an IVCT will cause serious adverse health effects.
Applications shall include a summary of test data and scientific evidence to support analytical and clinical validity of the test.
Through a technology certification, developers can submit an IVCT to the FDA for review, and if granted, the certification allows them to develop similar tests without going back for review each time.
The FDA must establish a program for rapid review of breakthrough IVCTs that provide effective treatment of life-threatening diseases
The federal government should work to ensure that regulatory oversight of laboratory tests does not limit patient access, impede innovation, or limit a test’s sustainability as a result of being unduly burdensome or beyond the fiscal capacity of the laboratory to reasonably validate and perform.
No aspects of LTDs shall be regulated under the FDA.
No later than 180 days after enactment of the bill, the secretary of health and human services shall report to the Senate’s Committee on Health, Education, Labor, and Pensions about recommendations to update clinical lab regulations and provide an assessment of LDT use during the 2020 pandemic response.
ExemptionsIVCTs being marketed before the VALID Act goes into effect
Low-risk tests
IVCTs that are granted emergency use
No new exemptions
Review timelinesThe FDA shall make a decision no later than 90 days after an application is submitted.No new requirements noted.
Sources: VALID Act and VITAL Act bills. Information is current as of March 28, 2022.

Related Resources:

What is a lab-developed test (LDT)?

Verifying Accurate Leading-Edge IVCT Development (VALID) Act

Verified Innovative Testing in American Laboratories (VITAL) Act

Take our survey about the VALID and VITAL acts

AACC Comments on the VALID Act

Regulation of Laboratory Developed Testing Procedures

Coalition for Innovative Laboratory Testing

The Role of Lab-Developed Tests in the In Vitro Diagnostics Market

VALID Act an “Important Step Toward the Long-Overdue Modernization” of Law Governing Diagnostic Tests

Reauthorization of the FDA User Fee Acts Takes Center Stage in Congress

Letter to senators about MDUFA and VALID Act

Pew and Massachusetts eHealth Collaborative Find the Frequency of Patient Mismatches Exceeds ‘Desirable Levels for Effective Data Exchange’

EMPIs may help clinical laboratories ensure their patients and medical records are properly matched with medical laboratory test results and specimens

Mix-ups between patients and their medical records, known in the healthcare industry as “patient mismatching,” happen far too frequently in hospitals and clinics worldwide. When surgery is involved, such mismatches can lead to deadly errors. However, clinical laboratories and pathology groups also must take steps to ensure patients, their medical records, and their biological specimens remain properly matched.

Once horrific incident in 2016 involved Saint Vincent Hospital in Worcester, Mass. Believing they were operating on a patient with a kidney tumor, surgeons mistakenly removed a healthy kidney from the wrong patient. The cause of the patient mismatch was a mix-up with CT scans. The two patients shared similar names, Managed Care reported.

Sadly, patient mismatching is not a new or rare problem. Patient mismatches often lead to delays, extra costs to fix duplicate information, and tragically, unnecessary surgery and inappropriate care, Healthcare Dive noted.

According to Managed Care, organizations working on solutions include:

Extent of Patient Mismatching Unknown

A recent study by Pew Charitable Trusts (Pew) in collaboration with the Massachusetts eHealth Collaborative (MAeHC) revealed that the rate of patient mismatching is difficult to measure.

“Incorrect matches could result in patients getting the wrong medicine, and failure to link records could lead to treatment decisions made without access to up-to-date laboratory test results,” Pew noted in an issues brief.

Pew and the MAeHC interviewed 18 hospital, medical practice, and health information technology exchange leaders. The respondents admitted that they are uncertain about the extent of the matching problem.

“They don’t know all the records that should be related and thus cannot understand what percentage of those are unlinked,” the researchers wrote.

Nonetheless, the researchers found that patient/record match rates fall “far below the desired level” for effective data exchange among organizations, Healthcare Dive reported. 

For pathologists and clinical laboratory managers, the Pew/MAeHC study had several key takeaways, such as:

  • “Match rates are far below the desired level for effective data exchange.
  • “An increased demand for interoperability—the exchange of electronic data among different systems—is fueling the desire for improvements.
  • “Match rates are difficult to measure.
  • “The methods in which records are received can affect match results.
  • “Different types of healthcare providers vary in their perspectives on the extent of the problem.
  • “Effective opportunities exist for organizations to more accurately link individuals’ health records.”

Other research studies suggest that patient match rates can fall to 50% or 60% when organizations share patients’ records between disparate healthcare network electronic health record (EHR) systems, the Office of the National Coordinator for Health Information Exchange (ONC) noted in a final report on the ONC’s Patient Identification and Matching Initiative. From experience, medical laboratories understand the challenges of matching information on a clinical laboratory test requisition to the right patient and can often see patient mismatches on a daily basis.

About $1,950 in medical care costs per patient during a hospital stay, and $1.5 million annually in denied claims per hospital, are associated with inaccurate patient identification, reported a survey conducted by Black Book Research.

“Patient matching is a fundamental function of being able to get the right records, for the right person, at the right time, so that timely decisions can be made about his or her health. There has to be a mechanism to ensure that you’re actually getting a copy of the records for the right person,” Mariann Yeager (above), CEO of the Sequoia Project told Modern Healthcare. The Sequoia Project advocates for nationwide health information exchange (HIE). (Photo copyright: Value-based Care Summit.)

Why Patient-Matching is Difficult

Respondents to the Pew study reported that challenges to correctly matching patients with their records include:

  • Receiving patient records that an organization did not expect;
  • Urban health systems serving patients through multiple sites;
  • High costs associated with matching solutions; and
  • Differences in how organizations capture, use, and link medical records.

When humans manually input patient data, Mary Elizabeth Smith could be listed as M.E. Smith or Mary E. Smith or even Liz Smith. Such data, when filed differently, can result in duplicate records for the same person, or, as St. Vincent’s found out, patient mismatches that have dire consequences, Managed Care noted.

“If there’s some kind of error in entering fields (name, address, date of birth), either when the patient’s coming in or in a previous entry, the matching can go awry,” Brendan Watkins, Administrative Director of Enterprise Analytics at Stanford Children’s Health, told Modern Healthcare.

Patient-Matching Solutions at Clinical Laboratories    

Clinical laboratories also have tackled patient-mismatching and have devised processing software solutions that ensure patients are correctly identified and matched with the appropriate records and specimens.

For example, Sonora Quest Laboratories (SQL), a subsidiary of Laboratory Sciences of Arizona, developed an enterprise-wide master patient index (EMPI). As reported by The Dark Report, Dark Daily’s sister publication, “The EMPI underpins all the patient-centric services that tomorrow’s clinical laboratory must support to be successful at meeting the needs of ACOs, PCMHs [patient-centered medical homes], and other emerging models of integrated clinical care.”

Other solutions suggested by respondents to a previous 2018 Pew survey include:

  • Unique patient identifier: Adoption of a patient identification number could help matching efforts, though patients have expressed privacy concerns. The idea is to use smartphones to validate patient data using digit codes. However, respondents told Pew, not everyone has a smartphone.
  • Data standardization: Respondents said standardization of data elements and formatting could impact match rates. But agreement on which elements to use for the match would be needed.
  • Referential matching: Healthcare providers could follow the banking industry and use outside sources, such as credit bureaus, to verify addresses and other data. Respondents to the Pew survey balked at the cost. 

One other technology not mentioned in the Pew survey but previously reported on by Dark Daily is biometric facial recognition, which would aid providers in identifying patients and matching them with their records. (See “Canadian Company Prepares to Use Biometric Facial Recognition for Positive Patient Identification with an In-Home Prescription Drug Dispensing Device,” July 9, 2018.)

With advancements in technology and interoperability, medical laboratory leaders and other healthcare leaders may soon be expected to achieve patient and record match rates of 100%. Pathology laboratories with EMPIs and other solutions may be well prepared to meet those challenges.

—Donna Marie Pocius

Related Information:

A Mismatch Made in America

Provider Demand for Accurate Patient Matching is High, Pew Says

Enhanced Patient Matching Is Critical to Achieving Full Promise of Digital Health Records

Hospital and Clinical Executives See Rising Demand for Accurate Exchange of Patient Records

Patient Identification Matching Final Report

Improving Provider Interoperability Congruently Increasing Patient Record Error Rates: Black Book Survey

Care Continuum Expands and Patient Matching Remains Problem without Single Solution

Medicare and Medicaid Programs Patient Protection and Affordable Care Act Interoperability

Sonora Quest Builds EMPI to Serve Patients and ACOs

Canadian Company Prepares to Use Biometric Facial Recognition for Positive Patient Identification with an In-Home Prescription Drug Dispensing Device