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

For Embattled Medical Laboratory Company Theranos, Bad News Keeps on Coming After Two Federal Inspections Show Problems in Certain Lab Practices

High rates of variability from one drop to another raise questions about the reliability of point of care testing equipment and companies that collect lab specimens only with finger sticks

Since last fall, one news report after another has come out with bad news for Theranos Inc., the high-profile medical laboratory company. The reports have ranged from dissatisfaction among Theranos’ partners, such as Walgreens and Capital BlueCross, to failed inspection reports from the federal Centers for Medicare and Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA).

In response, the embattled lab company in Palo Alto, Calif., has maintained that it is doing everything it can to correct any deficiencies in its clinical laboratory testing methods and to ensure its partners that its processes are scientifically sound and its methods valid. (more…)

Clinical Laboratories and Pathology Groups May See Fewer Fee-For-Service Payments as More Hospitals and Health Systems Become Self-Insured

As national health insurers push more risk to hospital systems and medical groups, many hospital administrators become more interested in establishing their own health insurance companies

New modes of provider reimbursement—such as bundled payments and budgeted payments—are motivating hospitals and health systems to reconsider their existing relationships with health insurers. Hospital administrators want to control the dollars they save by improving patient care, instead of allowing insurance companies to capture that money.

To accomplish these goals, more and more hospitals and health systems across the country are making one of three moves:

• Funding their own health plans;
• Partnering with health insurance companies; or,
• Buying health insurance companies.

As this trend gathers momentum, it will put the medical laboratories of hospitals in a much better position to regain access to patients. It can be expected that hospital administrators will include their own clinical laboratories and anatomic pathology providers in their own health insurance provider networks. (more…)

Apple Designs New App to Allow Use of iPhones to Recruit and Track Patients in Clinical Study as One Strategy to Become a Player in Healthcare Big Data

Researchers, including pathologists, can use Apple’s ResearchKit app to help collect and share genetic information about cancers and other diseases while building a huge genome database

By providing tools to allow users to be more productive in working with healthcare big data, several Silicon Valley giants hope to increase their presence in medical services. The latest company to enter the field is Apple Computers (NASDAQ:AAPL). In March it announced the availability of ResearchKit, an open-source software framework that turns the iPhone into a research tool.

Pathologists and clinical laboratory scientists have a stake in the healthcare big data trend, since more than 70% of the typical patient’s permanent medical record consists of medical laboratory test data. Thus, the products introduced by Apple, Google, and other Silicon Valley firms that are designed to help physicians and other professionals work with healthcare big data have the potential to transform the way value is harvested from these data sets.

It was Google (NASDAQ:GOOG) that took the first leap into the medical research arena. Last year, it launched Google X Life Sciences to assemble a database of the human genome. (See Dark Daily, “Google Takes First Steps to Create World’s Largest Human Genome Database as Part of Wider Strategy to Become a Major Player in Healthcare ‘Big Data’” October 14, 2014).

Apple’s strategy is to support researchers. Its ResearchKit is designed to be an open-source software framework that turns the iPhone into a research tool. It enables development of apps that help medical researchers recruit study subjects and collect health information through iPhone’s sensors and surveys. Because it is an open-source platform, researchers also can create apps for Android and Windows devices. (more…)

To Help Physicians and Patients, Medical Laboratories with BRCA Breast Cancer Tests Are Posting Mutation Data into ClinVar’s BRCA Database

Innovative use of crowdsourcing allows pathologists and genetic scientists to create a sizeable database of BRCA mutations that is accessible to clinicians and patients

There’s a new development in the longstanding battle over proprietary healthcare data versus public sharing of such information. Pathologists and clinical laboratory managers will be interested to learn that, when it comes to genetic testing of the BRCA mutation involved in breast cancer, a public data base of mutations is growing so rapidly that it may become the world’s largest repository of such information.

It was last year when the Supreme Court ruled in the gene patent case of Association of Molecular Pathology versus Myriad Genetics that human genes were not patentable. Following that decision, some financial analysts stated that Myriad Genetics, Inc. (NASDAQ:MYGN) retained a competitive advantage over other medical laboratories due to its huge database of mutations in the BRCA genes. (See Dark Daily, “Supreme Court Strikes down Myriad Gene Patents in Unanimous Vote; Decision Is Expected to Benefit Clinical Pathology Laboratories,”  July 1, 2013.) (more…)

Leaders Call on Anatomic Pathologists to Develop New Skills

Pathology is changing so quickly that anatomic pathologists need to add new skills to be successful in a clinical and business environment that is now more intensely competitive, particularly in two ways. First, regional and national pathology firms are raising the bar on clinical services in many subspecialties of anatomic pathology. Second, anatomic pathologists must have a better understanding of the business and financial skills required to succeed in today’s laboratory medicine marketplace.

One group on the forefront of these developments is the American Pathology Foundation (APF). “It’s no longer sufficient for a pathologist to come in every day and simply look at slides and make accurate diagnoses of biologic processes,” explained Luke Perkocha, M.D., Assistant Clinical Professor at the University of California San Francisco and chair of the APF’s conference program committee. “Demands for higher quality clinical services, declining reimbursement, and more intense competition for specimen referrals now require every pathology group practice to have skilled leaders. These pathologist business leaders need to understand the fundamentals of business and management. Just as medicine needs physicians who take the whole patient into account, pathology practices need leaders who take the whole business into account and think on a strategic leadership level.”

To give pathologists and lab directors an opportunity to learn the skills necessary to compete effectively today, the APF is conducting the Pathology Leadership Conference on Wednesday, September 17, 2008 at the Marriott Crystal Gateway Hotel in Arlington, Virginia. Perkocha noted that the day is organized around four specific areas of emphasis, with sessions led by experienced leaders of pathology groups from different areas of the country:

  1. Marketing. In this session, George Miaoulis, Jr., Ph.D., Professor of Marketing, at the University of Maine, will speak on, “Advanced Concepts in Marketing Pathology Professional Services: It’s Not Just a ‘Lab Test’ Anymore.”
  2. Finance. Two speakers from large pathology practices will address pathology billing issues. Del Berryman, Executive Director of Brown & Associates, in Houston, Texas, will discuss, “Evaluating and Selecting an Outside Billing Company-What Matters Most.” In the same session, Bob De la Torre, Practice Administrator at Pathology Services of Arizona, in Tempe, will discuss “Insider Expertise on Billing-Do it Yourself-Benchmark your Results.”
  3. Leadership. Pathology groups need an effective plan for succession, recruiting, and retaining skilled pathologists. Eric A. Hanson, Ph.D., Executive Consultant of Development Dimensions International, in Pittsburgh, Pennsylvania, will speak about, “Leadership Succession: Are you ready? What you should be thinking about now.” He will be followed by, Tedd Taskey, Associate Vice President, Pathology, at Slone Partners, in Denver, Colorado, discussing “Recruiting and Retaining Your Next Pathologist: Avoiding Expensive Mistakes.”
  4. Strategic business planning. Pathology practice mergers, consolidations, and integration of regional services will be discussed by Jeffery B. Drummond, an attorney with the law firm of Jackson Walker LLP, in Dallas, Texas, in his session on “Pathology Practice Mergers: New Imperatives and New Models.” Caitlin Cameron, CEO, of CellNetix Pathology & Laboratories, in Seattle, Washington, will address, “Pathology Practice Mergers: Smart Thinking in the Trenches and the Development of ‘Best Practices’.”

Founded in 1959, the American Pathology Foundation was probably the nation’s first pathology organization with a specific focus on business, management, and financial resources that would allow pathologists to succeed and prosper. Thus, it often has early and valid perspectives on unfolding trends within the anatomic pathology profession.

Perkocha’s message about the need for anatomic pathologists to support leadership skills within the pathology group practice setting is consistent with Dark Daily’s observations about unfolding changes in the anatomic pathology marketplace. With genetic medicine on the horizon, Wall Street and the national lab companies believe anatomic pathology will be hugely profitable because of new molecular assays. Community hospital-based pathology groups must respond to these strategic threats if they are to remain both clinically and financially viable. One way to acquire the necessary leadership and business skills is for pathology groups to send their business-minded partners to conferences such as the APF’s Pathology Leadership Conference.

Related Information:

;