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
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After AACC Presentation, Elizabeth Holmes and Theranos Failed to Convince Clinical Laboratory Scientists and the News Media about Quality of Its Technology

Clinical chemists at AACC pointed out that Holmes did not present data as promised. Instead, she did a speech that advertised her company’s latest medical lab analyzer

DATELINE: PHILADELPHIA—By now, the clinical laboratory industry and the world knows that Theranos Founder Elizabeth Holmes took the stage here last Monday at the annual meeting of the American Association of Clinical Chemistry (AACC). The content of her presentation was given wide play by the national press and, in general, Holmes appears to have failed to impress both the medical laboratory scientists in attendance and the journalists representing some of the world’s most prominent news outlets.

Among those in attendance was your Dark Daily editor, and I reported on the key elements of the presentation given by Holmes last week. However, the details contained within Holmes’ speech are only part of this important story. What is of equal or greater interest to medical laboratory professionals and pathologists is how their peers reacted to the invitation to have Holmes speak at the AACC meeting last week (a joint conference with the American Society for Clinical Laboratory Science—ASCLS), along with their reaction to what Holmes decided to present, their assessment of the diagnostic instrument she unveiled, and how they viewed the data she presented about certain assays performed by the Theranos “miniLab” device. (more…)

Anthem and Aurora Healthcare Create Joint Venture; Trends for Health Systems Entering Insurance Markets Continue to Grow

As health systems accept increased risk under healthcare reform, partnerships and provider insurance plans may also lead to greater rewards for hospitals and doctors

Even as pathologists, clinical laboratories, and other medical service providers adapt to value-based care initiatives and bundled payment plans, health systems are looking for ways to optimize both quality of care and treatment costs. In some cases this is the reason behind new joint ventures between provider and payer organizations.

Once such joint venture involves Anthem Blue Cross and Blue Shield and Aurora Healthcare. It was announced in an April press release.

The two partners created a newly licensed insurer called the Wisconsin Collaborative Insurance Company (WCIC). With both Anthem and Aurora Healthcare investing $5-million in the new insurance company, they will split equally any profits and losses derived from their new commercial health plan—Well Priority.

The plan includes services with 15 Aurora Healthcare hospitals as well as choice providers throughout the state. The first commercial plan will be available to fully insured and self-insured employers, with service starting January 1, 2017. (more…)

Delaware HIE Teaming Up with iSpecimen to Turn Remnant Clinical Pathology Laboratory Specimens into Cash

‘Explosive growth’ of biomarker discovery and development fuels demand for biospecimens, thus creating a new revenue source for clinical laboratories and pathology groups

Are health information networks alive and well in the United States? This sector of healthcare has been quiet in recent years. However, there is one statewide health information exchange (HIE) that is doing innovative things with clinical laboratory specimens.

The Delaware Health Information Network (DHIN) has entered into a novel collaboration that may help address the medical research community’s growing need for clinical specimens. At the same time, this agreement will also provide a much-needed new revenue stream for participating medical laboratories and hospitals.

With Medicare and health insurers reducing reimbursements for laboratory tests, medical laboratories and pathology groups are facing uncertain financial times. However, DHIN’s new partnership with iSpecimen of Massachusetts highlights the potential value of remnant clinical specimens—samples that otherwise would be discarded once patient testing is complete.

“The value of digitizing medical data extends beyond the obvious value of supporting direct patient care,” DHIN Chief Executive Officer Jan Lee, MD, said in a news release. “With informed patient consent, digital data can also help match clinical specimens with very specific research criteria. DHIN is proud to play a role in supporting such efforts to find new breakthrough treatments and cures.” (more…)

Theranos CEO Elizabeth Holmes Presents Scientific Data to Clinical Laboratory Chemists and Pathologists at AACC in Philadelphia

Yesterday’s presentation by Holmes was made to an audience that was clearly skeptical, and she was careful to avoid discussions about her company’s many issues and federal investigations

DATELINE: PHILADELPHIA, PA.—Yesterday, Elizabeth Holmes, CEO of Theranos, Inc., took the stage at the 68th AACC Annual Scientific Meeting & Clinical Lab Expo (AACC), the nation’s biggest clinical laboratory meeting, purportedly, for the first time ever, to deliver scientific data about her lab company’s diagnostic technologies. She also was there to answer questions from an expert panel before an attentive audience of clinical chemists and pathologists. A large number of journalists also were in attendance.

It may have escaped the notice of most of the audience—but not your intrepid editor—that the last song played over the PA system in the grand ballroom before Elizabeth Holmes was introduced and took the stage was “Sympathy for the Devil,” a big hit for The Rolling Stones in 1968. That song was an appropriate choice, since AACC’s invitation for Theranos to speak means the association is doing its own dance with the devil that some clinical chemists consider to be Theranos. (more…)

CMS’s ‘Innovation Center’ May Be the Affordable Care Act’s Lasting Legacy, Particularly as It Works to Replace Fee-for-Service Payments with New Reimbursement Models

Clinical laboratories and pathology groups feel the impact of many of the Center’s demonstration projects that move healthcare toward value-based reimbursement

One perennial criticism of this nation’s healthcare system is that it is slow to innovate. Technologies and management principals widely adopted by many industries may take a decade or longer to gain acceptance by hospitals, physicians, and clinical laboratories.

To encourage faster adoption by useful technologies and innovations by providers, the Affordable Care Act (ACA) has a section that is not well known. This part of the law, passed in 2010, created  the Center for Medicare & Medicaid Innovation.

The Innovation Center was included in the ACA legislation for the purpose of testing “innovative payment and service delivery models to reduce program expenditures … while preserving or enhancing the quality of care” for Medicare, Medicaid, or Children’s Health Insurance Program (CHIP) beneficiaries.” (more…)

Paper Microfluidic Devices Offer New Potential for Affordable Point-of-Care Tests for Use in Developing Countries That Have Few Clinical Laboratories

Paper-based devices could perform complex, multistep diagnostic tests at a fraction of the cost of traditional medical laboratory analysis

Many research teams are racing to create paper-based devices for medical laboratory tests. Their primary goal is develop a cheap, fast, reliable way to perform diagnostic testing in third world settings, where modern clinical laboratories are few and far between. One development team is working to combine lab-on-a-chip technologies with the low cost of paper-based platforms.

Meanwhile, over the past decade, point-of-care testing (POCT) has revolutionized diagnosis and treatment options for a myriad of conditions. In developing regions or remote areas, low-cost POCT improves accessibility to vital tests for infectious diseases, such as HIV, Malaria, and Ebola, as well as acute medical conditions, such as sepsis.

In the past eight years, Dark Daily has reported many times on the emergence of new POCT devices. From lactic acid screening to the lab-in-a-needle, which is used for detecting liver toxicity, the ability to produce a quick and accurate diagnosis without intensive clinical laboratory testing is growing.

However, one area where many POCT devices face challenges is in surviving extended environmental exposure. This does not pose an issue in major research hospitals or health systems. However, the consequences can be severe when considering the often harsh, resource-limited conditions of developing countries—one area in which POCT stands to offer the greatest value. (more…)

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