Jun 23, 2017 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Medical laboratory inpatient test volume may continue to decline as the Medicare hospital readmission reduction program expands in 2017 and state population health programs garner funding
We are now several years into the Medicare program that is designed to reduce hospital readmissions. Statistics from these years show encouraging progress in reducing the readmission rate of Medicare patients. This is a trend that has important implications for all hospital-based clinical laboratories.
Hospitals are the most expensive site of care in the entire healthcare system. In its ongoing battle to reduce healthcare costs, the Centers for Medicare and Medicaid Services (CMS) implemented a carrot-and-stick program called the Hospital Readmission Reduction Program (HRRP) aimed at lowering hospital readmission rates nationwide.
Established in 2013 by the Affordable Care Act (also known as Obamacare), the HRRP lowers reimbursements to acute care hospitals that have high rates of Medicare readmissions within 30 days of initial discharge, and increases reimbursements to hospitals that lower their readmission rates, a March 2017 Kaiser Family Foundation (KFF) Issue Brief explained.
And, according to the KFF, these programs are having an impact. Readmission rates dropped by 8% nationwide as hospitals found ways to avoid the stiff financial penalties and earn the financial rewards. Additionally, patients are increasingly choosing ambulatory care settings, or to receive care at home, rather than re-entering hospitals. This has lowered states’ readmission rates even further.
From a healthcare cost perspective, this is good news. However, these programs have had unintentional consequences as well. The federal initiatives and state population health programs responsible for lowering readmission rates also directly impact medical laboratories by simultaneously reducing the flow of inpatient testing volume.
At the same time, clinicians at the nation’s hospitals—in their efforts to avoid readmissions—have a motive to become more effective at ordering the right medical laboratory test at the right time, and to use the lab test results to more effectively treat the patient. Thus, for the nation’s hospital labs, the Medicare program to reduce readmissions has both an upside and a downside.
Programs, Data Mining That Help Providers Avoid Readmissions
Hospitals nationwide are operating programs aimed at attracting federal financial rewards for keeping people healthy, and from being admitted to hospitals due to conditions that could have been prevented, USA Today reported.
One such program involves Christiana Care Health System (Christiana Care) of Wilmington, DE. Christiana Care implemented CMS’ Care Link transitions program through the Center for Medicare and Medicaid Innovation (CMMI), also known as The Innovation Center, which, “supports the development and testing of innovative healthcare payment and service delivery models.”
The provider experienced a 20% drop in patients being readmitted within 30 days of surgery, due to its “bundled payment” plan for heart failure, the USA Today article noted. Hip and knee replacement readmissions were down 25% 30 days after discharge as well.
“Without the funding we got through CMMI, it’s hard to imagine we’d be in the position we’re in today,” stated Janice Nevin, MD, CEO of Christiana Care.
Janice Nevin, MD (above), CEO of Christiana Care Health System, Wilmington, DE, is concerned that the upcoming changes to the ACA will affect the funding the healthcare provider has received from the CMS Innovation Center. “I would strongly urge that we keep the commitment to CMMI (because) you have to innovate to learn,” she told USA Today. (Photo copyright: Christiana Care Health System.)
Changes to HRRP for Dual-Eligibles Could Affect Penalties
Some patients are more expensive than others. Patients who draw both Medicare and Medicaid funding simultaneously, for example. These “dual-eligibles” are disproportionately expensive for hospitals to treat, reported Modern Healthcare.
In fact, they are just 18% of CMS beneficiaries, but accounted for one-third of all Medicare fee-for-service (FFS) spending in 2013, according to a Medicare Payment Advisory Commission June 2016 demographic report.
CMS is proposing to adjust penalties in the HRRP to reflect the proportion of patients who are dual-eligible, presumably hoping the change will both lower costs and reduce penalties on healthcare providers.
Hospital Readmissions Data from 49 States
CMS data show that between 2010 and 2015 hospital readmission rates fell by 8%, reported Healthcare Finance News. Other key data recently released by CMS and reported by Healthcare Finance News:
· 49 states reduced avoidable hospital readmission rates since 2010;
· Vermont’s readmission rate rose slightly from 15.3% in 2010 to 15.4% in 2015;
· In 43 states, readmission rates fell by more than 5%;
· 11 states had a more than 10% drop in readmission rates;
· The fall in readmission rate translates to about 104,000 hospital readmissions avoided for Medicare beneficiaries in 2015 and 565,000 readmissions averted since 2010; and
· Avoidable admissions, occurring within 30 days of initial discharges, account for more than $17 billion in Medicare annual expenditures.
Action Steps for Clinical Laboratories
Pathologists and lab leaders need to efficiently work with colleagues, especially when caring for hospitalized patients with conditions relative to the HRRP. Clear and patient-friendly discharge instructions for diagnostics are important. And, the lab’s coordination with post-acute-care providers, such as skilled nursing facilities, on follow-up testing is key to avoiding unnecessary readmissions.
Regardless, medical laboratory inpatient test volume will likely continue to decline. As Dark Daily readers know, the decline in inpatient testing is associated with more than just the HRRP. The transition to new models of integrated care that has taken place over the last few years is also a factor, as Dark Daily reported in “Falling Inpatient Revenues at Many Hospitals is Sign of Healthcare’s Transition to New Models of Integrated Care and Changes in Medical Laboratory Test Utilization.”
Medical laboratory directors and sales teams are advised to continue their efforts at boosting outpatient volume to fill the inpatient void.
—Donna Marie Pocius
Related Information:
Hospitals Work to Keep Patients from Being Admitted
Aiming for Fewer Hospital U-Turns: The Medicare Hospital Readmission Reduction Program
49 States, DC Reduce Avoidable Hospital Readmissions
Dual-eligibles: The Next Target in Hospital Readmissions Penalties
June 2016 Data Book, Section 2: Medicare Beneficiary Demographics
Hospitals Mine Clinical Data to Help Reduce Costs and Avoid Readmissions, Creating Opportunities for Clinical Laboratories and Pathologists to Contribute to Improved Patient Outcomes
Falling Inpatient Revenues at Many Hospitals is Sign of Healthcare’s Transition to New Models of Integrated Care and Changes in Medical Laboratory Test Utilization
Jun 21, 2017 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
Despite blinding data and following protocols, a recent investigation in Bloomberg Businessweek shows that clinical laboratories can be at risk in deals with pharmaceutical and big data companies
While big data is transforming how healthcare is both researched and applied, it also offers opportunities for clinical laboratories to create additional revenue from the endless streams of data generated by diagnostic tests and genetic assays. However, these opportunities come at a cost.
Data mining and pharmaceutical companies are turning to medical laboratories for blinded data (patients’ names are removed) to aid in their research and marketing efforts. Although the data is blinded to adhere to consumer privacy protocols, a story on the biopharmaceutical company Alexion (NASDAQ:ALXN) in Bloomberg Businessweek shows how clinical laboratories may be at risk for civil and legal ramifications, as well as public relation concerns.
When Blinded Patient Data Is Not Blind
Despite requirements to anonymize medical data, the increased computing and data collection abilities of data mining companies make it possible to bridge gaps in information by collating multiple data sources. Companies then can make assumptions about the data with relative accuracy.
With Alexion’s drug Soliris, the blinded data was enough to locate healthcare professionals treating patients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disease of the blood, and atypical hemolytic uremic syndrome (aHUS) a rare disease of the immune system.
Cover of the Bloomberg Businessweek issue containing the article on Pharmaceutical companies’ use of blinded patient data for marketing high-cost “orphan drugs” that were developed to treat just one specific rare disease. (Photo copyright: Bloomberg Businessweek.)
On the surface, this seems like an ideal example of how making clinical laboratory and pathology data available to companies can be beneficial to patients and a victory for healthcare.
However, the Bloomberg Businessweek article highlights a darker side of the issue, noting, “Alexion set out to persuade doctors to test more frequently for PNH and aHUS—and to find a way to glimpse these test results, which traditionally have been shared only among the patient, the doctor ordering the test, and the lab.”
Liability and Risk in Age of Big Data
By reaching out to doctors and encouraging them to route lab tests to preferred medical laboratories with which they allegedly had partnered, Alexion could collect information and compare it to their database to pinpoint opportunities to sell their orphan drug Soliris. An orphan drug contains a unique pharmaceutical agent that was developed to treat a specific rare disease.
Five clinical laboratory companies are named in the story. While these laboratories might have followed regulations and the partnerships might be legal, news stories such as these could result in public relations crises and damaged reputations.
According to the Bloomberg Businessweek article, Alexion is resolving legal or regulatory concerns in at least seven countries. Though there is no precedent for medical laboratories assuming liability or being implicated in the crimes of a company to which they sold blinded data, the possibility exists.
Increased Scrutiny as Privacy Becomes a Public Concern
Healthcare big data continues to unlock new opportunities and create new approaches in treating disease and improving health around the world. However, as the public gains awareness of how healthcare big data is collected, shared, and used, greater scrutiny of how the data is handled, and the parties involved, will likely follow.
Dark Daily reported on the balancing act faced by laboratories in a 2016 e-briefing titled, “Trading in Medical Data: Is this a Headache or an Opportunity for Pathologists and Clinical Laboratories?”
That e-briefing cites a Scientific American article in which author Adam Tanner, a fellow at Harvard University’s Institute for Quantitative Social Science, states, “At present, the system is so opaque that many doctors, nurses, and patients are unaware that the information they record or divulge in an electronic health record, or the results from lab tests they request or consent to, may be anonymized and sold.”
In a similar story, Ancestry recently experienced how fast opinions can shift when certain online publications questioned the terms and conditions of the company’s AncestryDNA service. In a matter of days, the service went from an interesting example of consumer genomics to a trending topic on social media.
In the Slate article “Who Owns Your Genetic Data After a Home DNA Test?,” author Jacob Brogan notes, “Even if Ancestry maintains its current commitment to protecting its customers’ data, its willingness to profit from that information may raise red flags for the future of consumer genetic testing.”
While Ancestry might resolve its immediate troubles with an update to its terms of service governing how and when it sells the genetic information of its customers, the hit to the company’s reputation could continue to impact its business. This is something the five clinical lab companies affiliated with Alexion and named in the Bloomberg Businessweek story may be experiencing as well.
As competition increases and clinical laboratories work to cultivate and improve revenue streams and reduce costs, it remains important to stay ahead of trends—and public opinion—by choosing partnerships carefully and remaining transparent about how patient data is collected, shared or sold, and used.
—Jon Stone
Related Information:
When the Patient Is a Gold Mine: The Trouble With Rare-disease Drugs
Your Medical Data Is for Sale, and There’s Nothing You Can Do About It
How Data Brokers Make Money Off Your Medical Records
Who Owns Your Genetic Data After a Home DNA Test?
Jun 19, 2017 | Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Effective medical lab/physician collaborations to improve how lab tests are ordered and used can deliver big improvements in patient outcomes while reducing healthcare costs
Utilization management of clinical laboratory tests may be the single hottest trend in laboratory medicine today. Across the nation, medical laboratory scientists and pathologists are getting out of the lab to collaborate with physicians to meet the common goal of ordering the right test for the right patient at the right time.
“There are two urgent reasons why clinical laboratories and anatomic pathology groups are engaging with clinicians in projects to improve the utilization of lab tests and both involve money,” stated Robert L. Michel, Editor-In-Chief of The Dark Report. “First, an effective project to improve how physicians use lab tests can return immediate savings to both the lab and the parent hospital. Utilization management projects of this type have the goal of reducing or eliminating orders for duplicate tests, unnecessary tests, and outmoded lab assays. For hospital labs with shrinking budgets, the speedy savings that result from these lab test utilization efforts provide welcome relief.
Progressive Medical Laboratories Want to Deliver More Value
“Second, progressive medical laboratories that want to increase the value of their lab testing services to protect budgets and claim a fair share of value-based payments are going one step further,” explained Michel. “These labs are organizing collaborative projects with physicians and hospital administrators to leverage specific lab tests in ways that measurably improve patient outcomes while, at the same time, contributing to sizeable reductions in the overall cost per patient encounter.”
Today, almost every clinical laboratory and pathology group is under significant and sustained financial pressure. Payers continue to reduce the prices they pay for lab tests. Similarly, hospitals and health systems—facing flat or declining volume of inpatients—are pushing budget cuts across all their clinical service lines, including their labs. These trends force lab directors to pursue the twin strategy of cutting costs while increasing revenue.
Better utilization of lab tests is a business and clinical strategy that enables labs to meet both goals. When physicians do a better job of ordering the right test, and following up the lab test results with the right therapies, healthcare costs go down while patient outcomes improve.
Further, with Medicare and private health insurers continuing to move toward value-based reimbursement arrangements, any clinical lab that can step up and help its client physicians achieve documented improvements in patient outcomes has a legitimate claim to fair reimbursement under bundled and budgeted payment arrangements.
Keen Industry Interest in Utilization Management of Clinical Lab Tests
Proof of the keen interest that lab managers have in utilization management of clinical laboratory tests is the fact that a session on this topic was one of the best-attended at this spring’s Executive War College on Lab and Pathology Management.
Speaking first during this session was Tammy Fletcher, Administrator of Value-Based Services for Mayo Medical Laboratories (MML) in Rochester, Minnesota. As physicians and clinical pathologists at the Mayo Clinic develop and demonstrate clinical guidelines and protocols that utilize medical laboratory tests in the most effective way, Fletcher helps provide that information to client labs throughout the United States. This gives her a unique perspective on the best ways that lab managers can support successful lab test utilization management projects.
Tammy Fletcher (above), Administrator of Value-Based Services at the Mayo Medical Laboratories (MML), located in Rochester, Minn., is shown speaking at the Executive War College on Laboratory and Pathology Management last May. She is involved in helping the clinical laboratory clients of MML develop and implement effective utilization management programs to improve how physicians use medical laboratory tests. She will be speaking as part of a utilization management webinar that takes place on June 29. (Photo copyright: The Dark Report. Photo by Linda Reineke.)
Fletcher emphasized that, for utilization management initiatives to deliver optimal benefits, labs should follow a road map with five primary elements. They are:
- Assess and assemble;
- Message;
- Education and guidance;
- Analytics and evidence; and
- Payer collaboration.
She emphasized that labs should understand how improving utilization of clinical lab tests helps the parent hospital and health system in two important ways. One way is to score higher in assessments by accrediting bodies. The second way is to deliver measurable improvements that meet and exceed the criteria of the health insurers that are key to the institution’s success, including Medicare and Medicaid.
Utilization Management Successes at Minneapolis Health System
Next to speak was Bobbi Jo Kochevar, MBA, MT (ASCP), Director of Diagnostic Services at North Memorial Health Care in Robbinsdale, Minnesota. Her clinical laboratory serves multiple hospitals and an integrated health system. Thus, the lab team has the opportunity to develop utilization management projects that can involve providers in inpatient, outpatient, and outreach settings in ways that contribute to improved patient care.
Bobbi Jo Kochevar (above), MBA, MLS(ASCP), is Director of Care Coordination for Diagnostic and Therapy Services at North Memorial Health Care in Robbinsdale, Minn. In recent years, she and her clinical laboratory team have conducted several utilization management projects involving how physicians order and use medical laboratory tests. These projects have improved patient care while significantly reducing billing denials. Kochevar will be sharing the lessons learned and successes of her lab team’s utilization management projects during Dark Daily’s upcoming webinar on June 29. (Photo copyright: The Dark Report. Photo by Linda Reineke.)
What caught the audience’s attention during this session was Kochevar’s demonstration of how the clinical laboratory was able to engage clinicians in utilization management projects targeting use of such assays as homocysteine and Enterobacteria phage T4 in ways that improved patient care while also meeting payer criteria. The result was improved patient outcomes and a substantial reduction in billing denials because more claims were properly documented at first submission, thanks to improved physician adherence to both the clinical protocols and to documenting compliance to payers’ requirements.
Many Labs Working to Improve Utilization of Medical Laboratory Tests
Because utilization management of lab tests is now a high priority at most clinical labs and pathology groups, Dark Daily is hosting a special webinar that features Tammy Fletcher and Bobbi Kochevar as the speakers titled, “Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value.” The webinar takes place on Thursday, June 29, 2017, at 1PM EDT.
This is a must-attend for clinical pathologists, lab managers, and lab scientists who wants to:
- Develop their skills and knowledge in how to design an effective utilization management (UM) project; and
- Learn the best method for encouraging physicians and administrators to launch a winning collaboration and implement a UM project.
Fletcher will identify best practices in utilization management projects that she has learned from her work within the Mayo Clinic and with hospitals and health systems throughout the nation. She will discuss the five elements of the utilization management roadmap.
Nine Foundational Competencies in Utilization Management
Most importantly, Fletcher will describe the nine foundational utilization management competencies in detail. These range from leadership support and operations bandwidth to clinical content and knowledge diffusion. You’ll learn the essentials, as well as receive practical advice on specific pitfalls to avoid.
Kochevar will provide you and your lab team with the practical lessons learned from doing multiple, effective utilization management projects within her integrated health system. This is useful, handy knowledge that you can apply immediately.
An important topic that Kochevar will cover involves the five categories of lab test utilization. She will explain what needs to happen differently if a utilization management project is targeting repetitive or duplicate testing versus contraindicated screening and testing. Kochevar will help you understand how to customize a utilization management project to best address the different concerns and patient care improvement opportunities associated with each of the five different categories of lab test utilization.
The webinar on utilization management is ideal for clinical pathologists, lab managers, and anyone working on utilization management teams. It will help beginners understand the basics of working with clinicians on projects to improve lab test utilization while providing actual case studies and advanced techniques for intermediate and advanced practitioners.
To see the agenda and to register, use this link https://ddaily.wpengine.com/webinar/simple-swift-approaches-to-lab-test-utilization-management-proven-ways-for-your-clinical-laboratory-to-use-data-and-collaborations-to-add-value. (Or copy and paste this URL in your browser: https://ddaily.wpengine.com/webinar/simple-swift-approaches-to-lab-test-utilization-management-proven-ways-for-your-clinical-laboratory-to-use-data-and-collaborations-to-add-value.)
—Michael McBride
Related Information:
Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value
Increasing Costs for Genetic Tests are Busting Lab Budgets
Lab Test Utilization Delivers Big Gains at Cleveland Clinic
As Medical Laboratory Test Utilization Grows, Health Insurers Develop Programs to Manage Rising Costs
Naval Medical Center Study Reveals More than One-third of Genetic Tests are Misordered; Clinical Laboratories Critical to Improving Lab Test Utilization
Jun 16, 2017 | Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Pathologists and clinical lab managers can help physicians more effectively select appropriate genetic tests and better interpret results to identify the most appropriate therapies for their patients
Clinical laboratories and pathology groups aren’t the only healthcare providers being scrutinized for cost cutting and workflow efficiencies. Physicians ordering genetic tests are now in the spotlight thanks to a study of genetic test misordering by one healthcare institution.
In her award-winning presentation, “Genetic Testing Costs and Compliance with Clinical Best Practices,” given at the 2016 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists (ACOG), Kathleen Ruzzo, MD, revealed some startling facts to the attendees. Ruzzo is an obstetrics and gynecology (OB-GYN) resident at the Naval Medical Center (NMC) in San Diego. She and a team of NMC researchers had reviewed all genetic tests ordered during a 3-month period. They found that more than one-third of the genetic tests examined were unnecessary and had led to more than $20,000 in additional healthcare expenditures. This got the attention of the ACOG, which awarded her 1st prize.
Critical Importance of Staying Informed on Genetic Tests
The researchers examined 114 charts that contained billing codes for genetic tests. They evaluated the charts for compliance with practice guidelines and completed a cost analysis of the tests. The tests were classified per GeneReviews guidelines and were labeled as:
- Appropriate;
- Misordered/Not Indicated;
- Misordered/False Reassurance; or
- Misordered/Inadequate.
GeneReviews is an online database focusing on information, diagnosis, management, and counseling of single-gene disorders. It is published by the National Center for Biotechnology Information.
The researchers found that:
- 44 of the 114 charts examined (39%) were misordered based on the guidelines;
- 24 of the tests were labeled as misordered/not indicated;
- Eight tests were classified as misordered/false reassurance; and
- 12 tests were determined to be misordered/inadequate.
“We know there is an ever-expanding number of genetic tests available for clinicians to order, and there is more direct marketing to the patient,” stated Ruzzo in an Ob. Gyn. News article. “It can be difficult to stay on top of that as we have so many different clinical responsibilities.”
Kathleen Ruzzo, MD (above right) and Monica Lutgendorf, MD (above left) of the Naval Medical Center in San Diego, reviewed 114 genetic tests ordered during a three-month period. They discovered that 39% of the tests were misordered according to guidelines, costing a total of $75,000. (Photo copyright: Naval Medical Center.)
The actual testing was performed by Laboratory Corporation of America and occurred over a three-month period. The seven common genetic tests that were reviewed were tests for:
The cost analysis of the tests revealed that $20,000 could have been saved by following the GeneReviews guidelines. The total costs affiliated with the 114 tests reached $75,000. Potential savings were thus 26.6% of the total cost of the genetic tests involved in this study. In many clinical settings, if pathologists and medical laboratory managers could help physicians better utilize genetic tests while reducing the cost of such testing by almost 27%, that would be a major contribution. Plus, patients would be getting better care.
Ordering the Right Genetic Test Saves Money and Protects Patients
According to the National Institutes of Health (NIH), costs affiliated with genetic tests can range from less than $100 to more than $2,000 depending on the type and intricacy of the test. The NIH notes that many insurance companies will pay for genetic testing if ordered by a physician.
Ruzzo also shared that many of her cohorts were surprised at the results of the research.
“I think it opened a lot of people’s eyes … to be more meticulous about [genetic] testing and to ask for help when you need help,” she stated in the Ob. Gyn. News article. “Having trained individuals, reviewing genetic tests could save money in the healthcare system more broadly. We could also approve the appropriate testing for the patient.”
Ruzzo did admit there were limitations to the study; the researchers only looked at small amounts of tests for a short period and they did not concentrate on the consequences of the misordering to the patients.
Monica Lutgendorf, MD, Maternal Fetal Medicine Physician at the Naval Medical Center, was one of the coauthors of the paper. In the Ob. Gyn. News article, she described the findings as “a call to action in general for ob-gyns to get additional training and resources to handle the ever-expanding number of [genetic] tests.”
“I don’t think that this is unique to any specific institution. I think this is part of the new environment of practice that we’re in,” Lutgendorf concluded.
Due to the costs of genetic testing and the fact that so many physicians have not been able to keep up with all the latest advances in genetic medicine and testing, misordering will, most likely, continue to be a problem. Nevertheless, pathologists and clinical laboratory managers can serve a crucial role in helping physicians be more effective at selecting the correct genetic tests and assisting them in interpreting results to choose the most appropriate therapies for their patients.
Meanwhile, for those pathologists and medical laboratory professionals interested in developing effective utilization management programs for lab tests, Dark Daily is presenting a special webinar, titled, “Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value.” It will take place on Thursday, June 29, 2017 at 1PM EDT.
For information about this high-value webinar and to register, use this link (or copy this URL and paste into your browser: https://ddaily.wpengine.com/webinar/simple-swift-approaches-to-lab-test-utilization-management-proven-ways-for-your-clinical-laboratory-to-use-data-and-collaborations-to-add-value.)
—JP Schlingman
Related Information:
More Than One-Third of Genetic Tests Misordered, Study Finds
Genetic Tests Often Overused and Misinterpreted, Sometimes with Tragic Consequences
Webinar: Simple, Swift Approaches to Lab Test Utilization Management: Proven Ways for Your Clinical Laboratory to Use Data and Collaborations to Add Value
Research Awards Announced for ACOG 2017 Annual Meeting
Unnecessary Genetic Tests Wastes $500 Million Annually
Jun 14, 2017 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
New discoveries about the genetics of prostate cancer could lead to better tools for diagnosing the disease and selecting effective therapies based on each patient’s specific physiology
In recent decades, the biggest challenge for urologists, and for the pathologists who diagnosed the prostate tissue specimens they referred, has been how to accurately differentiate between non-aggressive prostate cancer, which can exist for decades with no apparent symptoms, and aggressive prostate cancer that kills quickly.
Thus, a research study that has identified unique genetic features within prostate cancer that can help determine if the cancer is aggressive or not, and whether certain drugs may be effective, is good news for men, for urologists, and for the clinical laboratories that will be called upon to perform testing.
These types of breakthroughs bring precision medicine ever closer to having viable tools for effective diagnosis of different types of cancer.
Genetic Fingerprints of Cancer Tumor Types
One such study into the genetic pathways of prostate cancer is bringing precision medicine ever-closer to the anatomic pathology laboratory. Researchers from the Princess Margaret Cancer Centre, which is associated with the University of Toronto Faculty of Medicine, have discovered that some tumors in prostate cancer have a genetic fingerprint that may indicate whether or not the disease will become more aggressive and less responsive to treatment.
Robert Bristow, MD, PhD, and Paul Boutros, PhD, conducted a study of nearly 500 Canadian men who had prostate cancer. Published in the journal Nature, the researchers examined the genetic sequences of those tumors, looking for differences between those that responded to surgery or radiation and those that did not.
In the video above, Dr. Robert Bristow, clinician-scientist at Princess Margaret Cancer Centre, discusses the findings of a key piece in the genetic puzzle that explains why men born with a BRCA2 mutation develop aggressive prostate cancer. (Caption and photo copyright: University Health Network/Princess Margaret Cancer Centre.)
According to a FierceBiotech article, approximately 30% of men who have a type of prostate cancer thought to be curable eventually develop an aggressive metastatic type of the disease. About half of the men who developed a metastatic form of cancer had mutations to three specific genes:
“This information gives us new precision about the treatment response of men with prostate cancer and important clues about how to better treat one set of men versus the other to improve cure rates overall,” stated Bristow in a University Health Network (UHN) press release.
In another study, researchers looked at 15 patients with BRCA2-inheritied prostate cancer and compared the genomic sequences of those tumors to a large group of sequences from tumors in less-aggressive cancer cases. According to a ScienceDaily news release, they found that only 2% of men with prostate cancer have the BRCA2-inherited type.
Knowing what type of cancer a man has could be critically important for clinicians tasked with prescribing the most efficient therapies.
“The pathways that we discovered to be abnormal in the localized BRCA2-associated cancers are usually only found in general population cancers when they become resistant to hormone therapy and spread through the body,” noted Bristow in the ScienceDaily release. If clinicians knew from diagnosis that the cancer is likely to become aggressive, they could choose a more appropriate therapy from the beginning of treatment.
Genetic Mutations Also Could Lead to Breast and Brain Cancer Treatments
BRCA mutations have also been implicated in breast, ovarian, and pancreatic cancers, among some other types. The knowledge that BRCA1 and BRACA2 mutations could indicate a more aggressive cancer is likely to spark investigation into whether poly ADP ribose polymerase (PARP) inhibitors could be used as an effective therapy.
PARP inhibitors are increasingly of interest to scientists. In addition to being used to treat some BRCA1/BRCA2-implicated cancers, two recent studies show that it could be effective in treating brain cancer with low-grade gliomas that involve a mutation to the gene isocitrate dehydrogenase (IDH), according to an article published by the National Cancer Institute and the National Institutes of Health (NIH).
Researchers of the study published in the journal Clinical Cancer Research investigated how PARP inhibitors impact DNA repair in gliomas.
Researchers of the study published in the journal Science Translational Medicine stated that they “demonstrate mutant IDH1-dependent PARP inhibitor sensitivity in a range of clinically relevant models, including primary patient-derived glioma cells in culture and genetically matched tumor xenografts in vivo.”
According to the UHN press release, the next step in using the knowledge that BRCA1 and BRCA2 may indicate a more aggressive prostate cancer is for researchers to create a diagnostic tool that can be used to determine what type of prostate cancer a man has. They expect the process to take several years. “This work really gives us a map to what is going on inside a prostate cancer cell, and will become the scaffold on which precision therapy will be built,” Boutros stated in a Prostate Cancer Canada news release.
Unlocking Knowledge That Leads to Accurate Diagnoses and Treatments
Research that furthers precision medicine and allows clinicians to choose the most appropriate treatment for individuals shows how quickly scientists are applying new discoveries. Every new understanding of metabolic pathways that leads to a new diagnostic tool gives clinicians and the patients they treat more information about the best therapies to select.
For the anatomic pathology profession, this shows how ongoing research into the genetic makeup of prostate cancer is unlocking knowledge about the genetic and metabolic pathways involved in this type of cancer. Not only does this help in diagnosis, but it can guide the selection of appropriate therapies.
On the wider picture, the research at the Princess Margaret Cancer Centre is one more example of how scientists are rapidly applying new knowledge about molecular and genetic processes in the human body to identify new ways to more accurately diagnose disease and select therapies.
—Dava Stewart
Related Information:
Genomic Hallmarks of Localized, Non-Indolent Prostate Cancer
Newly Discovered Genetic Fingerprint for Prostate Cancer Promises to Personalize Treatment
Prostate Cancer Team Cracks Genetic Code to Show Why Inherited Disease Can Turn Lethal
PARP Inhibitors May Be Effective in Brain, Other Caners with IDH Mutations
Chemosensitivity of IDH1-Mutated Gliomas Due to an Impairment in PARP1-Mediated DNA Repair
2-Hydroxyglutarate Produced by Neomorphic IDH Mutations Suppresses Homologous Recombination and Induces PARP Inhibitor Sensitivity
Prostate Cancer Researchers Find Genetic Fingerprint Identifying How, When Disease Spreads
Scientists Identify DNA Signature Linked to Prostate Cancer Severity
Jun 12, 2017 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Estimates are that more than three million people miss healthcare appointments each year due to transportation issues; that is true for patients with clinical lab test orders who never visit a patient service center
Patient no-shows, missed appointments, and rescheduling impact not only clinical laboratories and pathology groups but the entire healthcare community in lost time and wages. So, critical is scheduling that patient portal and electronic health record (EHR) developers focused first on implementing those technologies before moving on to billing and other aspects of health information technology (HIT). If patients don’t arrive at their appointments on time, everyone loses.
Thus, Internet and smartphone application (app) developers continue to refine and improve their scheduling software. Now, other companies outside of traditional healthcare also are capitalizing on this opportunity.
One such innovative company is Uber, a San Francisco-based transportation service company created in 2009 that enables people to order a local driver pickup via a free smartphone app. Last year, Uber began collaborating with MedStar Health, the largest healthcare provider in Maryland and Washington, DC, to help address the issue of missed appointments.
Getting Patients to Their Appoints is Half the Battle
An article in the Washington Business Journal noted that estimates place the cost of missed healthcare appointments as high as $150-billion per year in the US alone. And research published by the Journal of the Transportation Research Board suggests that up to 3.6-million people miss or delay appointments annually due to transportation issues. These exorbitant costs, combined with the necessity for patients to receive timely care, are compelling healthcare providers to develop innovative strategies to deal with missed appointments.
All of this is of interest to clinical laboratories, because a substantial number of patients who get medical laboratory test orders from the physicians never come to a patient service center to have their specimen collected. Not only does this mean that the patient (and his or her physician) won’t get the needed lab test results, but it means that the lab loses the opportunity to be paid for performing the tests that were wanted by the patients’ physicians.
“Half our battle is getting the patient to the appointment,” stated Pete Celano, Director of Consumer Health Initiatives for MedStar Institute for Innovation, Healthcare Dive reported. Celano, along with other representatives of the Uber/MedStar Health collaboration, spoke at the Connected Health Conference last December. Lindsay Elin, Director of Federal and Community Affairs at Uber and Daniel Hoffman, Chief Innovation Officer for Montgomery County in Maryland, joined Celano in discussing their shared experiences and insights with the collaboration during a session titled “Cities That Promote Health.”
“For patients who can afford it, we say ‘Please uber if and as you want to,’” Celano stated. “It could be less expensive to go to Georgetown University Hospital for example on an uber from most places than to park there, if we even have parking spots available.”
The Uber/MedStar collaboration may be especially beneficial for patients with disabilities who want to use the Uber to get to healthcare appointments. The Uber Accessibility website features a host of helpful instructions and tools to get patients started using Uber. (Photo copyright: ABC News.)
In the past, MedStar utilized local taxi services to diminish the amount of missed appointments. Celano stated that such services could be cost-prohibitive, cumbersome, and unable to meet the needs of patients who required assistance. Now, Internet technology, such as smartphone apps, can be used by providers in innovative and clever ways to improve the patient experience.
That’s the thinking behind encouraging patients to request an Uber driver for transportation to medical appointments. The pick-up is easily requested through a free smartphone app. Healthcare providers may also arrange and manage transportation for patients who do not own a smartphone. Patients also can order an Uber driver online by selecting the Uber icon on MedStar’s homepage.
The Power of Going Door-to-Door
The partnership has been successful. Celano stated that the cost of an Uber trip is about 60% of the cost of a cab in the DC area and patients can arrange for a car inside an hour time frame. MedStar also can cover the Uber transportation fee for patients with medical and financial needs.
“People ask me how it’s going and I say it’s all about the power of going door-to-door,” Celano stated in the Healthcare Dive article. He added that keeping scheduled appointment times can result in better outcomes for patients as well.
A CrossChx report titled, “The Cost of Now Shows” notes that the most common reasons for patients to miss scheduled appointments are:
- Lack of transportation;
- Amount of time between scheduling and the actual appointment;
- Emotional obstacles; and
- Believing that medical professionals do not respect patients.
Elin stated that other healthcare providers have expressed interest in utilizing Uber for patient transportation and that Uber has established a team to work solely with healthcare providers. Additionally, Uber’s uberASSIST program trains drivers to work with riders who may require specialized attention, such as senior citizens and the disabled.
“We firmly believe [that] with partnerships with healthcare providers, senior centers, [and] transit agencies we can do even more and reach more people,” Elin stated.
Taking Proactive Steps to Better Patient Care
The Uber/MedStar collaboration shows how internet technology and smartphone apps can be used by healthcare providers in clever ways to improve patient experience. Additionally, it should be understood as a market development that shows how a healthcare provider, attempting to deliver integrated care, recognizes that it must take proactive steps to get certain patients with chronic diseases to their appointments to manage them proactively and help prevent an acute event.
Clinical laboratory leaders should see this story in both dimensions. And then use those insights to identify how they might collaborate with high-tech companies to deliver lab services in different ways that help achieve better patient outcomes.
—JP Schlingman
Related Information:
‘It’s Door-to-Door’: MedStar, Uber Detail Partnership’s Progress
Insight: Tackling Healthcare’s Costly Problem of Missed Appointments
Why MedStar Health Just Teamed Up with Uber
Accessibility at Uber
Cities That Promote Health
MedStar Health Pays for Patients in Need to Get Uber Rides to Appointments
Cost-Effectiveness of Access to Nonemergency Medical Transportation: Comparison of Transportation and Health Care Costs and Benefits
Multi-channel Smartphone Spectrometer Enables Clinical Laboratory Testing Quickly and Accurately in Remote Regions
