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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CMS Notifies Theranos of CLIA Sanctions That Include Revoking Clinical Laboratory’s CLIA License and a Two-Year Ban on Holmes, Balwani, and Dhawan

Wall Street Journal obtained copy of letter sent by CMS to Theranos, dated March 18, 2016, that notified its executives of sanctions that include revocation of Theranos’ CLIA license and a process by which the medical lab company can appeal

Theranos, the high-profile clinical laboratory company, had a day of reckoning yesterday. That’s when The Wall Street Journal (WSJ) published a story revealing that Theranos was sent a letter by the federal Centers for Medicare & Medicaid Services (CMS) providing notice of sanctions.

In a letter to Theranos executives, CMS said it is prepared to:

• revoke the company’s CLIA certificate;

• impose a fine of $10,000 per day;

• suspend and cancel the lab’s approval to receive Medicare payments; and

• impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.

Dated March 18, the letter is addressed to Sunil Dhawan, MD, Director; Elizabeth Holmes, Owner; and Ramesh Balwani, Owner. (more…)

Era of Healthcare Big Data Analytics Poised for Rapid Growth; Clinical Pathology Laboratory Test Data Will Have Important Role

Tableau Software, IBM, Apple and others are building a future where analysis of clinical data guides personalized medicine, fuels research, and helps reduce healthcare costs

Use of big data in healthcare is poised to become a big business. That’s because new players in data analytics have begun to help providers and accountable care organizations (ACOs) effectively use data to improve their business operations, personalize care for patients, and/or discover new medical insights.

Because more than 70% of a typical patient’s permanent medical record consists of clinical laboratory laboratory test data, pathologists and medical laboratory scientists have a stake in the growth of big-data analytics, which are a core component in healthcare’s journey toward personalized medicine. (more…)

Clinical Pathology Laboratories Stand to Benefit as Patients Gain Control Over Their Healthcare Spending Through High-Deductible Health Plans

Smaller clinical laboratories and pathology groups should benefit from shift toward consumer-driven healthcare

High-deductible health plans (HDHP) are increasing in popularity as more consumers opt for lower annual premium costs in exchange for larger out-of-pocket expenses. This shift in health insurance could result in direct benefits for smaller clinical laboratories and pathology groups as more patients have a choice in where they purchase medical laboratory testing services.

From a policy perspective, employers and healthcare strategists hope that using HDHPs to engage consumers will help put market forces back into medicine. Because clinical laboratories and pathology groups increasingly find themselves excluded from provider networks, and fighting to keep access to patients, they should welcome the trend to consumer-driven healthcare.

A logical response to the HDHP trend would be for labs to begin posting their lab test prices on their websites. It would be equally useful to also post quality-performance and customer-satisfaction survey results to allow consumers to make informed choices about the labs they want performing their tests. (more…)

Two U.S. Studies Show Home-based Hospital Care Lowers Costs while Improving Outcomes and Patient Satisfaction

Studies show home-based hospital acute care results in fewer medical laboratory and diagnostic tests

Home-based hospital care (HBHC) is a care delivery model that is evolving at a rapid pace. To be effective, HBHC must improve patient outcomes while avoiding the expenses associated with an inpatient stay at a hospital.

However, significant growth in the number of patients treated in home-based hospital care programs would directly affect hospital-based clinical laboratories and pathology groups. Among other things, this would reduce the volume of inpatient testing while increasing the number of outpatient/outreach specimens.

Evidence is accumulating in favor of HBHC. New research shows that a New Mexico home-based hospital care (HH) program demonstrated cost savings and equal or better patient outcomes and patient satisfaction for acutely-ill patients compared to similar patients receiving in-hospital care. These new findings affirm similar results from a 2005 study of HBHC. (more…)

More Medical Laboratory Testing Expected as Retail Clinics Change Delivery of Routine Healthcare Services

As popularity of retail clinics grows among consumers, so does the likelihood of increased clinical pathology laboratory testing at these locations

Retail clinics (RC)—often called “rapid clinics”—are growing at a phenomenal rate. At the same time, more hospitals and health systems are deciding to participate in this growing trend, either by owning and operating such retail clinics in their communities or by providing the clinical staff.

Since the inception of this new care delivery model about six years ago, Dark Daily has predicted that consumers will support rapid clinics located in certain retail settings. Events to date bear this out. For that reason, pathologists and clinical laboratory managers should expect to see, over time, a steady increase in the menu of diagnostic testing offered by retail clinics.
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