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

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

Hosted by Robert Michel
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MedStar Health Latest Victim in String of ‘Ransomware’ Attacks on Hospitals and Medical Laboratories That Reveal the Vulnerability of Healthcare IT

Hollywood Presbyterian Medical Center makes headlines by opting to pay bitcoin ransom in order to quickly regain control of its computer systems

In recent weeks, hackers temporarily shut down MedStar Health—one of the biggest healthcare systems in the Washington, D.C. region—in the latest example of why cyberattacks are a threat not only to hospitals, but to anatomic pathology labs and clinical laboratories as well.

This latest incident is another example of a “ransomware” attack in which cybercriminals lock out computer users from accessing critical records and files. They then extort money by posting a digital ransom note warning users they must pay a ransom amount within a specific number of days if they want the digital key that will release their data.

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Leapfrog Group CEO Wants Healthcare Professionals to Stop Rallying Behind Quality Measure Critics

Binder argues that groups opposing ‘value’ often diminish clinicians’ role in hospital quality and patient outcomes; clinical labs often have the data on the outcomes generated by different clinicians

As healthcare moves steadily toward a value-based reimbursement model, Leapfrog Group CEO Leah Binder is urging healthcare providers to rethink their opposition to quality measures and criteria that reward improved medical outcomes.

“Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder stated in an editorial she penned for Modern Healthcare. “Value will succeed either way, but it will be so much better infused with the knowledge and gifts of practicing providers.”

Many clinical laboratory managers and pathologists know that the Leapfrog Group carries quite a bit of clout in healthcare. Its members include some of the largest corporations in the United States. Collectively, Leapfrog’s members provide health benefits to more than 37 million Americans in all 50 states, and spend tens of billions of dollars on healthcare each year, according to this 2009 Leapfrog Group Fact Sheet. This is why health insurers, hospitals, and physicians pay attention to Leapfrog’s programs and public statements.

“If all hospitals implemented just the first three of Leapfrog’s four ‘leaps’ (our recommended quality and safety practices): over 57,000 lives could be saved, more than 3 million medication errors could be avoided, and up to $12.0 billion could be saved each year,” states the fact sheet.

Physician Opposition to Value-based Reimbursement Models Will Backfire

Leapfrog’s Binder argues the value-based reimbursement movement will succeed for three reasons:

1. “Value” is enshrined in the Affordable Care Act, with the Centers for Medicare and Medicaid Services (CMS) now tying almost 6% of hospital Medicare reimbursement to performance, and Congress replacing the sustainable growth-rate (SGR) with a value-based formula.

2. Private insurers also are transitioning their payment models, with 40% of commercial payments linked to value, up from 9% a year earlier. In addition, consumers, who are paying more out of pocket, are increasingly sensitive to value.

3. Big data is enabling quality to be quantified. Binder pointed to the leadership of the National Quality Forum (NQF) and others in showing “we can defensibly measure the quality side of the value equation.”

Binder warns that arguments made in the name of clinicians to denounce specific quality measures can backfire. In particular, she pointed to a study published in the BMJ that concluded clinicians have little impact on the “standardized mortality ratio,” therefore they should not be held accountable for it.

“Here’s the damaging assumption in the study: The only way physicians or nurses improve patient survival is by avoiding killer mistakes. Surely clinical skill impacts mortality more than that,” Binder stated in her Modern Healthcare editorial.

Similarly, Binder pointed to a study published in the Journal of the American Medical Association (JAMA) that also minimized the impact of clinicians. The study compared how United States hospitals scored on CMS composite safety measures versus alternative measures the researchers invented based on process quality composites. She summarized the findings as stating, “Some hospitals excel on the invented quality composites but fail on the CMS safety composite. Illogically, the researchers conclude that the CMS safety composite is flawed. One might just as well conclude that the researchers’ composites are flawed.”

“Ultimately, this paints a dismal portrait of individual clinicians. … If you excel on some but not all measures, the measures are wrong and you don’t excel at anything,” she stated.

Leapfrog Group CEO Leah Binder is urging healthcare professionals to embrace the move toward value-based reimbursement and rethink their opposition to quality measures that reward high-quality patient care. “Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder says. (Photo copyright: Aaron Eckels/Crain’s Detroit Business.)

Leapfrog Group CEO Leah Binder is urging healthcare professionals to embrace the move toward value-based reimbursement and rethink their opposition to quality measures that reward high-quality patient care. “Clinicians have a choice: Seize the momentum of the value movement to finally get rewarded for excellence, or recite tired political talking points that minimize your life’s work,” Binder says. (Photo copyright: Aaron Eckels/Crain’s Detroit Business.)

Leapfrog Group Advocates Transparency for Both Insurers and Patients

The Leapfrog Group was formed in 2000, a year after the Institute of Medicine’s (IOM’s) landmark report on medical errors, “To Err Is Human: Building a Safer Health System,” in which the IOM estimated that preventable medical errors caused 44,000 to 98,000 deaths annually, with an associated cost of $17 billion to $29 billion.

The watchdog organization operates out of Washington, D.C. and is made up of more than 170 of the nation’s largest purchasers of healthcare, including:

AARP;

Boeing;

Lockheed Martin;

Marriot International;

University of Michigan; and

• the Florida Healthcare Coalition.

Through its annual hospital surveys and research, the non-profit urges insurers and patients to use transparency to improve the safety and quality of the healthcare system.

The Leapfrog Group’s movement for transparency has grown to include more than 1,700 hospitals that participate in its annual survey on safety, quality, and resource use. In 2015, a record 1,750 hospitals submitted a survey, representing 46% of hospitals nationwide. It also has focused attention on reducing early elective deliveries, launched a pay-for-performance program, and designed a Hospital Safety Score to help consumers to make better healthcare decision.

Providers Should Seek Transparency

While negotiations about quality measures have reached a fever pitch, Binder would like to see providers insist on transparency and accountability for their patients, a step she says would validate clinicians’ work and expertise.

“While thoughtful critiques of measures are important, politically-motivated denial of measures is destructive in unintended ways,” Binder stated in her editorial for Modern Healthcare. “It often follows the unfortunate pattern of these studies in assuming that providers perform at essentially the same level of quality and/or their actions can’t be linked to patient survival or healing,” she observed.

“If all physicians and nurses believed their work had such modest impact, the burnout problem might be even worse,” continued Binder. “People who choose a career in healthcare tend to be bright, competitive and caring, and they won’t last long if they believe their talents make virtually no difference.”

As noted above, since the Leapfrog Group represents many of the major purchasers of healthcare, Binder’s recent comments should grab the attention of pathologists and clinical laboratory executives. They would do well to anticipate continued calls for more quality and more measurement of quality in healthcare as the movement toward value-based reimbursement marches on. Contributing value to hospitals, physicians, and payers is quickly becoming the new paradigm for clinical laboratories and pathology groups.

—Andrea Downing Peck

Related Information:

Clinicians Must Push Back Against Critics Challenging the Role of Quality Measures

Standardized Mortality Ratios Should Not Be Used to Benchmark Hospitals, Study Concludes

Leapfrog Group Fact Sheet

Concerns About Using the Patient Safety Indicator-90 Composite in Pay-for-Performance Programs

To Err Is Human: Building a Better Health System

Human Longevity Inc. Unleashes Power of Whole-Genome Sequencing to Unlock Keys to Healthy Aging; Research May Lead to New Clinical Laboratory Tests

Human genome pioneer J. Craig Venter’s newest project seeks to ‘change the way medicine is practiced’ by creating genomic-based medicine model

With little fanfare or public notice, a start-up company in San Diego is busy sequencing the largest number of whole human genome sequences in the world. The knowledge expected to result from this effort promises to revolutionize healthcare, as well as clinical laboratory testing.

Human Longevity Inc. (HLI) is a genomics and cell therapy company that has assembled the largest human genome sequencing operation in the world. It’s goal is to use whole genome sequencing and cell-based therapeutics to redefine aging and “meaningfully extend the human lifespan.”

“HLI’s mission is to identify the therapeutically targetable mechanisms responsible for age-related human biological decline, and to apply this intelligence to develop innovative solutions to interrupt or block these processes, meaningfully extending the human lifespan,” HLI states on its website. “We are trying to tackle some of the most vexing diseases like cancer, heart disease, and diabetes … we are working to change the way medicine is practiced through our genomic-focused, preventive model.” (more…)

Sure Genomics Offering $2,500 Whole Human Genome Profile to Consumers, but ‘Doctor Prescribed’ Medical Laboratory Test Caught the Attention of the FDA

FDA sends letter to the California-based start-up concerning clearance for SureDNA test kit before accepting pre-orders from consumers

Competition to market whole-human genome sequencing to consumers is heating up. Not only is the Food and Drug Administration (FDA) watching these developments, but it is taking action to regulate companies that offer direct-to-consumer whole-human genome sequencing in developments that should be watched by clinical laboratory managers and pathologists.

One example is Sure Genomics. It claims to be breaking barriers by offering a $2,500 at-home whole human genome test to consumers.

The company believed the new test kit, called SureDNA, would escape FDA restrictions on the direct sale of health reports to consumers. However, the FDA’s recent letter to the California-based startup indicates Sure Genomics may face the same regulatory roadblocks that have stymied other direct-to-consumer genetic testing companies. (more…)

Systemic Errors at Canadian Forensic Laboratory Motherisk Make National News and Provide another Example of Consumer Interest in Accuracy of Clinical Laboratory Testing

Investigations find hair-strand analysis at hospital-based laboratory was ‘inadequate and unreliable’ for tests performed over a period lasting five years or more

Another case of a medical laboratory that produced inaccurate test results for an extended period of time has been making headlines in Canada. It demonstrates, once again, that both the news media and consumers are keenly interested in stories involving systemic lab test errors that could possibly lead to patient harm.

In this specific instance, the lab testing involved forensic testing for drugs and alcohol that were part of the Canadian legal system and thus were not clinical laboratory tests used by physicians to diagnose and treat patient care. Concerns center on the methodology used by the lab in question to perform forensic toxicology tests over a period of at least five years. Another source of concern is how proficiency testing was conducted at this laboratory.

In covering this case, the Toronto Star published a story pointing out that “flawed” results from Canadian forensic testing laboratory Motherisk may have been used in thousands of child protection cases and numerous criminal proceedings. Because of this fact, the owner of Motherisk, Toronto’s Hospital for Sick Children (SickKids) has been put into an unwelcome spotlight. (more…)

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