Jun 10, 2016 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Some cancer researchers worry that these patients may not benefit from such clinical laboratory testing because effective therapeutic drugs don’t exist for their cancers
What can be more patient-centric than for a medical laboratory company to offer free genetic tests for cancer? That’s the strategy of a firm in Canada that is offering free cancer genomics testing to 1,500 cancer patients. However, some cancer researchers responded to this offer with skepticism.
In March, Contextual Genomics of Vancouver, British Columbia, began providing its cancer genomics test free to the first 1,500 patients whose oncologists submitted tumor samples. These specimens would be tested using the company’s Find It hotspot cancer panel.
“You could call it marketing, but it’s making this test available to people who haven’t had access to it before,” stated Chris Wagner, Contextual Genomics President and CEO, in a CBC News Canada interview.
Contextual Genomics says its Find It test focuses on “90 hotspots across 29 known cancer genes and analyzes seven exons of three genes,” with the specific genes and mutations selected because they are “actionable and can potentially direct patient treatment, indicate prognosis, and support diagnosis.” Oncologists that participate in this commercial pilot program will receive a comprehensive report that interprets the sequencing results. The report also identifies any approved drugs or clinical trials that target the patient’s gene mutations. (more…)
May 13, 2016 | Coding, Billing, and Collections, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Managed Care Contracts & Payer Reimbursement, Management & Operations
Faster than expected transition from fee-for-service healthcare should grab attention of clinical laboratories and anatomic pathology groups who face financial unknowns under new payment systems
Clinical laboratory executives should take note of a key financial fact. The transition from fee-for-service healthcare to value-based reimbursement is occurring at a faster clip than the Department of Health and Human Services (HHS) anticipated last year when federal officials announced a plan to tie 30% of traditional Medicare spending to alternative payments models by the end of 2016.
That means the transition away from fee-for-service payment for medical laboratory tests and other healthcare services is moving ahead of schedule. As evidence, HHS recently announced it reached the 30% target at the start of 2016, nearly a year ahead of the schedule laid out when the Obama Administration outlined a plan to reward healthcare providers based on quality of care rather than the volume of services they provide.
(more…)
May 4, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency
National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all medical laboratories and pathology groups.
Over the past 30 months, Theranos has regularly asserted that its laboratory-developed tests (LDTs) were under review by the Food and Drug Administration (FDA). For example, in an interview published in the December 14, 2014, issue of The New Yorker, Theranos Founder and CEO Elizabeth Holmes stated, “We believe that to realize our vision we must operate at the highest levels of excellence… And the FDA’s stamp of approval is seen as an indicator of the quality of a product.”
Thus, it would be ironic if the problems in the quality of clinical laboratory tests uncovered by federal CLIA inspectors at the Theranos lab facility in Newark was used by the FDA to justify their intent to regulate LDTs. The FDA has already released a report to the public that identified instances where laboratories running LDTs were alleged to have reported inaccurate lab test results to patients and their physicians. (more…)
Apr 27, 2016 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
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 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
