News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
Sign In

Thirty US Congress Members Ask HHS To Send COVID-19 Testing Funds Directly to Clinical Laboratories

US Representatives want clinical laboratories to have better support for their increased efforts to expand testing for the coronavirus

On June 8, Congressmen Tom Reed (NY-23), Scott Peters (CA-52), and 28 other members of the US House of Representatives sent a letter to Secretary of the Department of Health and Human Services (HHS) Alex Azar requesting that funds from the Paycheck Protection Program and Health Care Enhancement Act (H.R.266) be sent directly to clinical laboratories that have heavily invested in increasing their COVID-19 testing capacity.

In their letter, the Representatives wrote, “As you are aware, the recently enacted Paycheck Protection Program and Health Care Enhancement Act (PPPHCE Act) invests $25 billion in the [Public Health and Social Services Emergency Fund (PHSSEF)], including $11 billion for states, localities, territories, and tribes, to enhance all aspects of COVID-19 testing capacity. This funding is in addition to the funds already appropriated to the PHSSEF under the CARES Act.

“While laboratories are eligible, along with other providers, for these funds,” they continued, “there have been no federal funds specifically designated for the laboratories that have stepped up in this public health crisis and have made significant investments to expand access to COVID-19 testing despite 40-60 percent reductions in regular commercial volume due to the economic lockdowns.

“As laboratories work to maintain their investments in critical resources for testing platforms, reagents, swabs, and PPE, as well as hiring, training, and overtime pay for the laboratory workforce, we urge HHS to direct a portion of funding that has not already been allocated towards these efforts. These funds will ensure that labs can continue to rapidly scale up diagnostic and antibody testing, particularly for healthcare workers, first responders, and other Americans on the frontlines of this pandemic,” concluded the Representatives.

ACLA President Made Similar Plea for Direct Funding to Clinical Laboratories

As Dark Daily reported in “Federal Government Is Sending Nearly $11 Billion to States for COVID-19 Clinical Laboratory Testing and Testing-Related Activities,” in April, Julie Khani, President of the American Clinical Laboratory Association (ACLA), sent a similar letter to Azar urging the HHS to provide some of the stimulus money directly to clinical laboratories.

“In order to deliver accurate, reliable results for patients at a national scale, we must allocate funding to support [clinical laboratories’] expanded efforts,” she said in a statement following an April 27 meeting at the White House.

In her letter, Khani wrote, “It is essential that HHS allocate $10 billion from the fund to support labs’ further expansion of testing capacity to fulfill the testing needs of all of the states and to protect the lives and livelihood of all Americans.

“Further,” she continued, “HHS should note that investing in the nation’s laboratories will not only enhance testing capacity in the short-term, but it also will allow the country to benefit from a robust testing infrastructure for the duration of the COVID-19 pandemic and beyond.”

President Trump signed H.R.266 into law on April 24. It includes $25 billion earmarked for research, development, validation, manufacturing, purchasing, administering, and expanding capacity for COVID-19 testing. According to the language of H.R.266, that includes, “tests for both active infection and prior exposure, including molecular, antigen, and serological tests, the manufacturing, procurement and distribution of tests, testing equipment and testing supplies, including personal protective equipment needed for administering tests, the development and validation of rapid, molecular point-of-care tests, and other tests, support for workforce, epidemiology, to scale up academic, commercial, public health, and hospital laboratories, to conduct surveillance and contact tracing, support development of COVID-19 testing plans, and other related activities related to COVID-19 testing.”

“As the demand for testing continues to grow, clinical laboratories need dedicated funding to plan for challenges that lie ahead. Strong federal coordination and leadership is essential, and we’re looking forward to working with HHS to ensure that laboratories have the resources necessary to continue to expand our role at the forefront of the nation’s response,” said Julie Khani (above), President of the American Clinical Laboratory Association (ACLA), in a press release following the June 8 letter sent to HHS by 30 members of Congress requesting funds from H.R.266 be sent directly to clinical laboratories. Khani will be speaking on federal policies now impacting clinical laboratories at the upcoming 25th annual Executive War College on Laboratory and Pathology Management in New Orleans on July 14-15. (Photo copyright: ACLA.)

Financial Struggles for Hospitals and Clinical Laboratories

This new round of stimulus funding comes at a time when many providers and clinical laboratories are struggling financially, despite the influx of COVID-19 patients.

“Across the country, laboratories have made significant investments to expand capacity, including purchasing new platforms, retraining staff, and managing the skyrocketing cost of supplies. To continue to make these investments and expand patient access to high-quality testing in every community, laboratories will need designated resources. Without sustainable funding, we cannot achieve sustainable testing,” said Khani in an ACLA statement.

As the COVID-19 coronavirus pandemic evolves, federal regulations, as well as emergency funding for COVID-19 testing that is provided by federal legislation, will evolve in unexpected ways. For that reason, clinical laboratory leaders will want to closely track announcements by such federal agencies as the Department of Health and Human Services, the Centers for Medicare and Medicaid Services, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the Federal Emergency Management Administration as decisions are made about how to assign the $25 billion authorized in H.R.266 for “testing.”

—Stephen Beale

Related Information:

Reps. Reed and Peters Lead 28 House Members in Calling on HHS to Allocate Additional Federal Support to Clinical Laboratories for COVID-Testing

Reed Leads Members in Requesting More Widespread COVID-19 Testing

Amid Growing Demand for Testing, Lawmakers Call on HHS to Designate Resources for Clinical Laboratories

The Paycheck Protection Program and Health Care Enhancement Act: Summary of Key Health Provisions

H.R.266 – Paycheck Protection Program and Health Care Enhancement Act

Special Bulletin: HHS Announces How it Will Distribute Additional Funds to Providers Under CARES Act

What Clinical Diagnostic Laboratories and Manufacturers Need to Know about the CARES Act

Latest Updates on the CARES Act Public Health and Social Service Emergency Fund

Lab Test Volumes Plummet as Patients Put Off Care

COVID-19 Bonanza: Stimulus Hands Health Industry Billions Not Directly Related to Pandemic

$75B Relief Bill Provides ‘Much-Needed Lifeline’ to For-Profit Hospitals

7 Healthcare-Related Items You May Have Missed in the $2T Coronavirus Stimulus Package

Coronavirus Strains Cash-Strapped Hospitals, Could Cause Up to 100 to Close Within A Year

ACLA Statement on Expanding Access to Testing

ACLA Letter to HHS on PHSSEF Direct COVID19 Test Funding

Federal Government Is Sending Nearly $11 Billion to States for COVID-19 Clinical Laboratory Testing and Testing-Related Activities

Canadian Scientists and Medical Researchers Urge Health Canada to Regulate Laboratory-developed Tests

Lack of regulations and quality management jeopardizes the quality and safety of LDTs, claim experts in clinical laboratory medicine in a commentary to Canadian policymakers

Health Canada is the latest government healthcare organization under pressure to enact legislation that regulates laboratory-developed tests (LDTs). In a public commentary, several members of the Institute of Health Policy, Management and Evaluation (IHPME) at the University of Toronto in Ontario, urged Canadian lawmakers to follow the European Union’s lead and find ways to monitor LDTs in Canada.

The IHPME members published their comments in the Canadian Medical Association Journal (CMAJ), a peer-reviewed journal owned by Joule Inc., a subsidiary of the Canadian Medical Association. In it, they claim “recent expansion of the molecular diagnostics industry has revealed weaknesses in Canada’s regulatory system for laboratory-developed tests, which are not subject to statutory regulations on medical devices.”

For pathologists and clinical laboratory professionals in both Canada and the United States, these recent actions show the concerns many experts have as they watch the explosive growth in the use of laboratory-developed tests in both countries. In many ways, the swift advances in molecular and genetic diagnostics is outrunning the ability of government regulators to keep pace with use of LDTs in clinical care settings.

In their commentary in CMAJ, the IHPME members also claim the review and evaluation of LDTs in Canada is inconsistent. Some LDTs they say, may endure stringent assessments and have endorsements by clinical guidelines or findings that are published in scientific journals. Other LDTs, however, may have no analysis at all.

In addition, the IHPME members point out that there is no national registry kept of LDTs. They theorize that a lack of proper regulation, controls, and quality management “has potentially jeopardized the delivery of quality, safe, timely, and appropriate care.”

The researchers calling on Health Canada to address these issues include:

  • Kelly Holloway, PhD, Research scientist at University of Toronto;
  • Fiona A. Miller, PhD, Professor of Health Policy and IHPME Chair in Health Management Strategies;
  • François Rousseau, PhD, Professor, Department of Molecular Biology, Medical Biochemistry and Pathology, Faculty of Medicine, Laval University, Quebec;
  • Alberto Gutierrez, PhD, Partner, NDA Partners LLC, former Director, Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health (CDRH);
  • Stuart Hogarth, PhD, Lecturer in Sociology of Science and Technology, University of Cambridge, Cambridge, UK.
During an exclusive presentation offered by The Dark Report (Dark Daily’s sister publication) in 2015, Alberto Gutierrez, PhD (above), who at that time was Director, Office of In Vitro Diagnostics and Radiological Health at the FDA, said, “LDTs are an area that will be difficult to regulate. There is a broad set of tests. Some of the LDTs are very good. Some of them require a lot of expertise from the pathologists and some of them don’t. Regulating LDTs in a way that makes sense and that does not disrupt what’s going on [in clinical laboratories] is going to be difficult.” (Photo copyright: FDA.)

Canadian Scientists Call on Health Canada to Take the Lead on Regulating LDTs

In the US, the FDA has been making moves to regulate LDTs since 2010, with much opposition from clinical laboratories and In Vitro Diagnostic (IVD) manufacturers. The FDA describes LDTs as internally designed clinical laboratory tests that are developed, manufactured, and used within a single laboratory. They have not undergone government regulatory review, can be simple or complex, and can be utilized to detect a variety of analytes.

Health Canada is the name of a department that falls under the purview of the Minister of Health and is part of Canada’s Health Portfolio. It is responsible for helping Canadians maintain and improve their health. Other agencies included in the Health Portfolio are:

According to the IHPME paper, however, Health Canada currently does not have a way to regulate LDTs, and no government agency in that country is responsible for the oversight of laboratory-developed tests. Only LDTs that are marketed as test kits are evaluated and reviewed by Health Canada. 

“The current laboratory regulatory system in Canada involves a mixture of public and private entities and operates with oversight from provincial governments, nongovernmental organizations, and professional societies,” the IHPME paper states, adding, “most provinces and territories rely on voluntary standards that are unevenly applied, with little auditing and systematic testing to ensure quality.”

The authors also note that the current lab regulations in Canada apply only to the operations of the medical laboratories themselves, encompassing such things as lab environments, personnel, accreditation, and quality control. They believe the loophole regarding LDTs needs to be addressed, and they urged Health Canada to “demonstrate leadership” by subjecting these tests to regulations that are currently applied to medical devices and pharmaceuticals.

Other Countries Regulate LDTs, though Not Without Controversy

In support of their call to action, IHPME researchers noted that Australia, the EU, and the US all have taken steps to regulate LDTs.

The Australian government began oversight of LDTs in 2010 by subjecting high-risk LDTs to external evaluation and then tracking them in a public registry.

An EU regulation, which was passed in 2017, will administer regulatory review of LDTs manufactured on an industrial scale, which targets commercial laboratories. The law exempts LDTs utilized within individual hospital laboratories and should be fully implemented by 2022.

Though on its radar since the 1990s, in 2010, the FDA officially announced its intent to regulate LDTs in the US. The agency released an initial draft approach for doing so starting in 2014, held a public workshop on the topic in 2015, and released a discussion paper in 2017. At this time, however, the FDA is not regulating LDTs, though the agency remains open to the possibility.

Dark Daily has reported extensively over the years on the development of LDTs and the controversy surrounding the FDA’s moves to regulate them.

According to the FDA website, problems with several high-risk LDTs have been identified, including:

  • Claims that are not adequately supported with evidence;
  • Lack of appropriate controls which may yield erroneous results; and
  • Falsification of data.

However, in “FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?Dark Daily, May 4, 2016, Roger D. Klein, MD, JD, Chair of the Association for Molecular Pathology (AMP) Public Relations Committee, and Medical Director, Molecular Oncology at Cleveland Clinic, called a report released by the FDA in 2015 “mostly a hodgepodge of outlier assays.”

The FDA’s report, titled, “The Public Health Evidence for FDA Oversight of Laboratory Developed Tests,” reviewed 20 case studies of LDTs for Lyme disease, ovarian cancer, whooping cough, fibromyalgia, prostate cancer, autism, breast cancer, melanoma, Vitamin D, and other conditions. The agency concluded that in many instances “patients have been demonstrably harmed or may have been harmed by tests that did not meet FDA requirements.”

Klein noted, however, that “The 20 tests described by FDA are mostly a hodgepodge of outlier assays including tests that were never offered, tests for which comparable FDA assays perform poorly, tests for poorly defined disorders with psychologic components, and use of an FDA-approved test off-label.” He continued, “That FDA could find only these dubious examples out of the many thousands of laboratory-developed procedures (LDPs) that benefit patients each day, calls into question the agency’s rationale for expanding its regulatory scope to include LDPs.”

Perhaps this is why the FDA has yet to implement regulations for LDTs. The controversy continues.

Whether Health Canada will accept the advice of the IHPME scientists and take steps to regulate laboratory-developed tests in Canada remains to be seen. As more LDTs are created and manufactured, however, it is probable that governments will continue to evaluate the administration and oversight of laboratory-developed tests.

In both Canada and the United States, pathologists, clinical laboratory managers, and executives at in vitro diagnostic manufacturers can expect an ongoing tug-of-war between government regulators and the lab industry over the most appropriate ways to regulate LDTs.

—JP Schlingman

Related Information:

Health Canada Needs to Act on Laboratory-developed Diagnostics

Laboratory Developed Tests

The Public Health Evidence for FDA Oversight of Laboratory Developed Tests: 20 Case Studies

Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs)

FDA Discussion Paper on Laboratory Developed Tests

FDA Announces Intention to Regulate LDTs as Devices

FDA Official Makes Case in Favor of LDT Guidance

Regulation of Laboratory Developed Tests by FDA: Time for the Agency to Cease and Desist Until Congress Enacts Legislation

Johns Hopkins University Study Finds Laboratory-Developed Liquid Biopsy Tests Can Give Different Results; Call for ‘Improved Certification’ of Medical Laboratories That Develop These LDTs

FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?

Medicare’s Independence at Home Program Saves Federal Government Millions While Paying Millions to Health Providers That Meet Quality Benchmarks

This CMS pilot program is another opportunity for clinical laboratories to provide medical lab test services and collect specimens outside of traditional sites of healthcare services

Clinical laboratories and anatomic pathology groups are once again reminded to develop strategies that support the increasing number of physicians providing medical care in nontraditional outpatient settings. Now in its seventh year, the Medicare Independence at Home program is reviving the tradition of healthcare providers making house calls to elderly patients who have certain chronic illnesses, and so far, the results are promising.

Primary care teams at the 14 participating healthcare providers include physicians, nurse practitioners, physician assistants, pharmacists, social workers, and other staff.

Hospital networks participating in the federal Centers for Medicare and Medicaid Services (CMS) primary care pilot program are saving the government millions of dollars, while improving healthcare outcomes for their chronically ill patients and earning millions in return.

A CMS fact sheet states that to qualify for incentive payments, participating providers must meet performance thresholds of at least three of the following six measures:

  • Follow-up contact within 48 hours of a hospital admission, hospital discharge, and emergency department visit;
  • Medication reconciliation in the home within 48 hours of a hospital discharge and emergency department visit;
  • Annual documentation of patient preferences;
  • Hospital admissions for ambulatory care sensitive conditions; and
  • Emergency department visits for ambulatory care sensitive conditions.

Northwell Health House Calls a Model of Success

The Independence at Home (IAH) demonstration project from the federal Center for Medicare and Medicaid Innovation (CMMI) was established in 2010 as part of the Affordable Care Act. In 2018, Congress extended the pilot for another two years and increased the number of eligible participants from 10,000 to 15,000.

Northwell Health House Calls has been a model of success within the federal IAH demonstration project. The New York-based healthcare provider has annually reduced costs while improving health outcomes for participating patients.

Karen Abrashkin, MD (above), Medical Director of Northwell Health House Calls, examines a patient during a home visit checkup. In a news release, she said, “We know our older, chronically ill patients want to receive medical care at home as long as possible. Programs like Independence at Home involve a large interdisciplinary team working in concert to deliver individualized patient care. We are dedicated to providing high-quality care and giving patients access to the appropriate healthcare provided at the right time.” (Photo copyright: Northwell Health.)

Results from the fifth year of the program (Oct. 1, 2016 through Sept. 30, 2017) show Northwell Health reduced per-beneficiary-per-month (PBPM) expenditures to $2,703, compared to a spending target of $3,874, according to the most recent CMS Fact Sheet. In return, Northwell Health received an incentive payment of more than $1.82 million. That’s the largest payout among the eight practices that met incentive payment quality benchmarks and savings requirements.

According to the news release, patients in Northwell’s House Calls program receive comprehensive, coordinated care, that includes ultrasounds, radiology, electrocardiograms, sleep studies, clinical laboratory work, physical exams, occupational and speech therapy, and social services, as well as intravenous fluids and prescription refills.

Physicians, nurse practitioners, and other clinicians are available for urgent, same-day visits during the work week. The team also is accessible 24/7 to answer clinical questions from patients and caregivers, or to arrange urgent services.

In an interview with Crain’s New York Business, Karen Abrashkin, MD, Medical Director of Northwell Health House Calls, said, “We’ve achieved cost savings by providing really good primary care and ongoing care for medical illnesses. We’re responsive to patients whenever they have a change in condition.”

The chart above is taken from the federal Independence at Home (IAH) Year Five Fact Sheet, released October 25 of this year. CMS found that “the actual expenditures for IAH practices’ applicable beneficiaries were approximately 8.4% (equating to $33.5 million) below their spending targets, an average reduction of $2,711 per beneficiary. Thirteen out of the 14 IAH practices reduced the per-beneficiary-per-month (PBPM) expenditures relative to the practice’s PBPM spending target. (Chart copyright: Centers for Medicare and Medicaid Services.)

How Patients Qualify for Medicare’s IAH Program

To qualify for the Independence at Home pilot, patients must:

  • Currently be Medicare beneficiaries with two or more chronic health conditions;
  • Need help with activities of daily living; and
  • Have had a hospital admission and rehab stay within the past year.

Though he praises the House Calls program’s success, Kristofer Smith, MD, Senior Vice President of Population Health Management at Northwell Health stated that the program should be expanded slowly and only extended to those who would benefit most from in-home care.

“We need to be thoughtful about making sure we’re not expanding beyond the populations for whom we know it works because [it would] dilute the results,” he told Modern Healthcare.

US Congressman Michael C. Burgess, MD, (R-Texas), said in a statement last July announcing a proposed bill to make the program permanent, “The Independence at Home program is a fiscally-responsible solution to help seniors access quality healthcare and expand the capacity of our nation’s healthcare system. Under this program, high-needs patients continue to receive individual care in the comfort of their homes, reducing unnecessary hospitalizations and allowing physicians and primary care teams to spend more time with patients.” [Photo copyright: US Congress.]

Will Medicare’s Primary Care at Home Program Continue Beyond the Pilot?

The Independence at Home pilot is scheduled to end Dec. 31, 2020. What happens next is uncertain. Efforts in Congress to create a permanent home-based primary care program under Medicare have not yet gained traction despite bipartisan support.

Thomas Cornwell, MD, CEO, Home Centered Care Institute (HCCI), a national non-profit organization focused on advancing home-based primary care, is skeptical the primary care provider workforce could meet increased demand. He told Home Health Care News that question is “the greatest unknown.”

Nevertheless, the apparent success of Medicare’s Independence at Home pilot program should be a wakeup call to clinical laboratories and anatomic pathology groups that the trend of providing medical services in lower-cost settings will likely continue.

That means medical laboratory leaders should be developing strategies to support providers who are delivering medical care in nontraditional healthcare environments.

—Andrea Downing Peck

Related Information:

Independence at Home Demonstration Performance Year 5 Fact Sheet

Medical House Calls Program Improves Care, Reduces Costs of Treating Elderly Patients at Home

Northwell Wins Big in Medicare Pilot Home-Based Primary Care

Northwell Shows Savings in Medicare Testing House Calls

Elderly and Frail Patients Benefit from Receiving Care in the Comfort of Their Homes

Independence at Home Saves Medicare 10 Times More than ACOs

Reps. Burgess, Dingell, Merchant, and Thompson Introduce the Bipartisan Independence at Home Demonstration Act of 2019

Society to Improve Diagnosis in Medicine Forms Coalition to Address Preventable Diagnostic Errors; Proper Use of Clinical Laboratory Test Is One Goal

SIDM estimates approximately one in 10 patients with serious medical conditions are initially misdiagnosed, a problem that can be addressed if the right medical laboratory test is ordered at the right time for individual patients

Clinical laboratory leaders know that lab tests are essential to a large proportion of medical diagnoses. Therefore, any formal effort to reduce diagnostic errors that affects how doctors order and use lab tests also will impact medical laboratories that perform those tests.

One such formal effort is underway, led by the Society to Improve Diagnosis in Medicine (SIDM). Dubbed the Coalition to Improve Diagnostics (CID), the collaboration comprises more than 50 leading healthcare and patient advocacy organizations, all joined to end diagnostic errors, one of the most common causes of preventable medical errors.

“Diagnostic error is one of the most important safety problems in healthcare today and causes the most patient harm,” said Paul L. Epner, CEO and co-founder of the SIDM, in a news release. “While many organizations have diagnostic quality on their radar, it generally is not seen as a top priority. Those who’ve joined the coalition acknowledge that diagnostic quality and safety are vital to improving healthcare.”

To participate in the coalition, organizations must promise to pursue ways to circumvent troublesome diagnostic errors and submit action plans to the SIDM outlining proposals to diminish such errors. There are no fees associated with being part of the coalition.

12-Million Patients Each Year Affected by Diagnostic Errors

Epner told Modern Healthcare that this coalition is the only one that exists that focuses solely on diagnostic errors and ways to eradicate them. “There are a lot of systematic things that we understand are problems, but we aren’t very good at implementing solutions,” he said. “In terms of having standard solutions, we are early.”

The National Academy of Medicine (NAM) defines diagnostic error as “the failure to establish an accurate and timely explanation of the patient’s health problem(s) or to communicate that explanation to the patient. Simply put, these are diagnoses that are missed altogether, wrong, or should have been made much earlier.”

The SIDM website lists the following key sources for acquiring data on diagnostic errors:

  • Autopsy data;
  • Physician self-reports of experiencing diagnostic error;
  • Patient self-reports of experiencing diagnostic error;
  • Hospital incident reporting systems;
  • Statistical analysis of unexpected hospitalizations;
  • Research studies designed to measure diagnostic error; and
  • Medical malpractice claims data.
“Providing an accurate medical diagnosis is complex and involves uncertainty, but it’s obviously essential to effective and timely treatment,” Paul L. Epner, CEO and co-founder of the SIDM, said in a news release announcing the formation of the coalition. “Nearly everyone will receive an inaccurate diagnosis at some point in their life and for some, the consequences will be grave. Major improvement is needed to systematically identify how to improve diagnostic quality and reduce harm to patients.” (Photo copyright: Society to Improve Diagnosis in Medicine.)

The SIDM states that diagnostic errors affect an estimated 12-million patients in the US each year, and that approximately one in 10 patients with a serious medical condition are initially misdiagnosed. In addition, an estimated 40,000 to 80,000 people die each year from diagnostic errors in US hospitals, and it is probable that at least that many patients suffer from permanent disability annually due to improper diagnosis. It is also likely that diagnostic errors cause more harm to patients than all other medical errors combined and are responsible for an increasing number of malpractice cases, the SIDM notes.

John’s Hopkins Finds Most Misdiagnoses in Three Categories of Medicine

A study published in the peer-reviewed journal Diagnosis, reported that one in three malpractice cases that resulted in death or serious harm to patients are due to misdiagnosis. The research for this study was carried out by a team from the Johns Hopkins University School of Medicine and was funded by the SIDM.

After analyzing more than 55,000 malpractice claims, the researchers found that 34% of those cases which resulted in death or permanent disability could be attributed to inaccurate or delayed diagnosis, an SIDM analysis of the John’s Hopkins study noted.

The research team also examined underlying disease states to search for misdiagnosis patterns and discovered that three quarters or 74.1% of the misdiagnosed cases occurred in just three categories of medical conditions:

  • Cancer (37.8%);
  • Vascular events (22.8%); and
  • Infection (13.5%).

These serious cases resulted in $1.8 billion in malpractice payouts over the course of 10 years, according to the SIDM. 

“It is not just inconvenient to have a wrong or delayed diagnosis. For many patients, misdiagnosis causes severe harm and expense, and in the worst cases, death,” said David Newman-Toker, MD, PhD, Director, Armstrong Institute Center for Diagnostic Excellence at Johns Hopkins University School of Medicine, in an SIDM news post. “If we’re going to reduce serious harms from medical errors, major strides must be made to improve diagnostic accuracy and timeliness. This study shows us where to focus to start making a difference for patients. It tells us that tackling diagnosis in these three specific disease areas could have a major impact on reducing misdiagnosis-related harms.”

The John’s Hopkins research confirms that misdiagnosis is a common and costly form of medical errors that can have catastrophic results. The team concluded that it will take a system-wide effort involving physicians, patients, and their families to improve the accuracy of diagnosis.

The SIDM’s Coalition to Improve Diagnostics is one such effort and is primarily supported by a $2.45 million grant awarded by the Gordon and Betty Moore Foundation. The main purpose for this grant was to help increase awareness about diagnostic errors and develop ways to prevent such errors in the future. 

“We think this is a new frontier of safety and quality we want to be part of,” Daniel Yang, MD, Program Officer for Diagnostic Excellence Initiative at the Moore Foundation, told Modern Healthcare.

Clinical laboratory tests are essential to the diagnostic process. Therefore, lab managers and staff should constantly review their procedures to ensure accuracy in testing and reporting of results to ordering physicians. If preventable medical errors are to be significantly reduced, labs will be a big part of the team effort that will make it happen.

—JP Schlingman

Related Information:

Coalition Tackling Diagnostic Errors Gains Some Traction

Four New Organizations Commit to Improve Diagnostic Quality and Safety

Improving Diagnosis in Health Care

The Frequency of Diagnostic Errors in Outpatient Care: Estimations from Three Large Observational Studies Involving US Adult Populations

40+ Healthcare Organizations Launch Unprecedented Effort to Improve Accuracy and Timeliness of Diagnosis

Analysis: One in Three Malpractice Cases with Serious Patient Harms Are Due to Misdiagnosis

Serious Misdiagnosis-Related Harms in Malpractice Claims: The “Big Three” – Vascular Events, Infections, and Cancers

Customized Cancer Vaccines Based on Individual Patients’ DNA Could Soon Be a Reality, Might Require Diagnostic Support from Anatomic Pathology Labs

Pharmaceutical developers are combining genetic sequencing and precision medicine to create new drug therapies and cancer treatments designed for specific patients


Most anatomic pathologists are aware of the rapid advances in the field of cancer immunotherapy—sometimes also called immune-oncology. This is an area of healthcare where precision medicine and personal genetics become crucial elements in developing more effective drug regimens.

Scientists are combining those two areas of research to develop vaccines designed for specific individuals based on the genetic characteristics of their DNA. This is why there are great hopes that cancer immunotherapy can be used to artificially stimulate the immune system to treat cancer and improve the system’s natural ability to fight cancer.

San Francisco-based Genentech, a subsidiary of Swiss pharmaceutical giant Roche (OTCMKTS:RHHBY), is working with German company BioNTech to develop such personalized vaccines for cancer patients. Each vaccine would be based on the unique deoxyribonucleic acid (DNA) of a patient’s tumor.

Unlike typical vaccines, Genentech’s drug would not be taken as a preventative measure. Instead, patients receive it after being diagnosed with cancer.

Though still being tested, this new line of research indicates that development of personalized cancer treatments is progressing, as scientists strive to customizetreatments tumor by tumor. 

Creating One-Off Vaccines

To create each vaccine, a patient first undergoes a tumor biopsy. The sample tissue is then sent to a genetics laboratory for full genome sequencing. Sophisticated algorithms analyze the genetic data and locate targets within the tumor that have the most potential for training the patient’s immune system to attack the existing cancer. A customized vaccine is then created for and administered to the patient.

“What’s truly revolutionary about this approach is that each vaccine uses a common molecular backbone—mRNA—that is uniquely tailored to an individual patient,” said Todd Renshaw, former Global Head of Clinical Contract Manufacturing at Genentech, in an article posted on the company’s website. “It’s the next step in personalized medicine.”


“You can imagine a scenario where every single cancer patient would benefit from this vaccine,” Ira Mellman, PhD (above), Vice President at Genentech, told MIT Technology Review. “That’s unheard of.” (Photo copyright: Profiles of the National Academy of Sciences.)

Vaccines are typically used to train the body’s immune system to attack specific diseases that infiltrate the body from the outside. However, cancer tumors are formed within the body’s own tissues, making it difficult for the immune system to detect them. Thus, vaccines haven’t shown much promise for treating cancer.

“Vaccines work by exposing the immune system to ‘non-self’ proteins known as antigens, priming it to recognize and eliminate the invaders. But in the case of cancer cells, most proteins are the same as those on healthy cells,” said Lélia Delamarre, Senior Scientist in Cancer Immunology at Genentech, in the online article. “This makes it hard to identify which antigen to use in a vaccine.”

Global testing on the vaccine has commenced with a focus on ten cancers in upwards of 560 patients.

Barriers to Creating Individual Vaccines

The American Cancer Society estimates there were 1,735,350 new cancer diagnoses in the US in 2018—and 609,640 cancer deaths—making it the second leading cause of death in the US after heart disease.

A truly customized cancer treatment in the form of a vaccine could be a major breakthrough in treating this deadly disease. However, there are significant barriers to developing such a vaccine.

For starters, the vaccines cannot be manufactured in batches, packaged, warehoused, or delivered to pharmacies in bulk. The personalized vaccines must be manufactured in single patient doses, which could be prohibitively costly.

Nevertheless, this research represents an exciting opportunity for anatomic pathologists and clinical laboratories with genetics capabilities which would be needed to secure and sequence tumor biopsies for guiding the creating of the customized vaccines.

Pathologists should track this trend closely and work within their group practices to ensure they have the analyzers, informatics, and expertise required to perform this type of testing for patients within their communities. 

—JP Schlingman

Related Information:

We Can Now Customize Cancer Treatments, Tumor by Tumor

A New, Personalized Vaccine is Targeting the Deadliest Cancers in America

Personalized Cancer Vaccines Look Promising in Two New Studies

What’s New in Cancer Immunotherapy Research?

Decoding Cancer

Precision Medicine Institute

Independent Clinical Laboratories in Maryland May Need to Step-up Outreach with Hospitals as New CMS Program Launches Jan. 1

Clinical laboratory leaders will want to pay close attention to a significant development in Maryland. The state’s All-Payer Medicare program—the nation’s only all-payer hospital rate regulation system—is broadening in scope to include outpatient services starting Jan. 1. The expanded program could impact independent medical laboratories, according to the Maryland Hospital Association (MHA), which told Dark Daily that those labs may see hospitals reaching out to them.

The Centers for Medicare and Medicaid Services (CMS) and the state of Maryland expect to save $1 billion by 2023 in expanding Maryland’s existing All-Payer Model—which focused only on inpatient services since 2014—to also include primary care physicians, skilled nursing facilities, independent clinical laboratories, and more non-hospital settings, according to a CMS statement.

Healthcare Finance notes that it represents “the first time, CMS is holding a state fully at risk for the total cost of care for Medicare beneficiaries.”

Value of Precision Medicine and Coordination of Care to Clinical Labs

“If a patient receives care at a [medical] laboratory outside of a hospital, Maryland hospitals would be looking at ways to coordinate the sharing of that freestanding laboratory information, so that the hospital can coordinate the care of that patient both within and outside the hospital setting,” Erin Cunningham, Communications Manager at MHA, told Dark Daily. Such a coordinating of efforts and sharing of clinical laboratory patient data should help promote precision medicine goals for patients engaged with physicians throughout Maryland’s healthcare networks.

The test of the new program—called the Total Cost of Care (TCOC) Model—also could be an indication that Medicare officials are intent on moving both inpatient and outpatient healthcare providers away from reimbursements based on fees-for-services.

CMS and the state of Maryland said TCOC gives diverse providers incentives to coordinate, center on patients, and save Medicare per capita costs of care each year.

“What they are really doing is tracking how effective we are at managing the quality and the costs of those particular patients that are managed by the physicians and the hospitals together,” Kevin Kelbly, VP and Chief Financial Officer at Carroll Hospital in Westminster, told the Carroll County Times. “They will have set up certain parameters. If we hit those parameters, there could be a shared savings opportunity between the hospitals and the providers,” he added. (Photo copyright: LifeBridge Health.)

The TCOC runs from 2019 through 2023, when it may be extended by officials for an additional five years.

How Does it Work?

The TCOC Model, like the earlier All-Payer Model, will limit Medicare’s costs in Maryland through a per capita, population-based payment, Healthcare Finance explained.

It includes three programs, including the:

  • Maryland Primary Care Program (MDPCP), designed to incentivize physician practices by giving additional per beneficiary, per month CMS payments, and incentives for physicians to reduce the number of patients hospitalize;
  • Care Redesign Program (CRP), which is a way for hospitals to make incentive payments to their partners in care. In essence, rewards may be given to providers that work efficiently with the hospital to improve quality of services; and,
  • Hospital Payment Program, a population-based payment model that reimburses Maryland hospitals annually for hospital services. CMS provides financial incentives to hospitals that succeed in value-based care and reducing unnecessary hospitalizations and readmissions.

CMS and Maryland officials also identified these six high-priority areas for population health improvement:

  • Substance-use disorder;
  • Diabetes;
  • Hypertension;
  • Obesity;
  • Smoking; and
  • Asthma.

“We are going to save about a billion dollars over the next five years, but we are also providing better quality healthcare. So it’s going to affect real people in Maryland, and it helps us keep the whole healthcare system from collapsing, quite frankly,” Maryland Gov. Larry Hogan, told the Carroll County Times.

OneCare in Vermont, Different Approach to One Payer

Maryland is not the only state to try an all-payer model. Vermont’s OneCare is a statewide accountable care organization (ACO) model involving the state’s largest payers: Medicare, Medicaid, and Blue Cross and Blue Shield of Vermont, Healthcare Dive pointed out. The program aims to increase the number of patients under risk-based contracting and, simultaneously, encourage providers to meet population health goals, a Commonwealth Fund report noted.

Both Maryland’s and Vermont’s efforts indicate that payment plans which include value-based incentives are no longer just theory. In some markets, fees-for-service payment models may be gone for good.

Clinical laboratory leaders may want to touch base with their colleagues in Maryland and Vermont to learn how labs in those states are engaging providers and performing under payment programs that, if successful, could replace existing Medicare payment models in other states.

—Donna Marie Pocius

 

Related Information:

Maryland’s Total Cost of Care Model

Maryland All-Payer Model Expands to Include Outpatient Services

Gov. Hogan Sees Maryland Model as Example for U.S. Healthcare

The Maryland Model

Gov. Larry Hogan, Federal Government Sign Maryland Model All-Payer Contract

CMS Expands Maryland’s All-Payer Program to Outpatient Services

Vermont’s Bold Experiment in Community Driven Healthcare Reform

;