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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Congress Takes Aim at Healthcare Technology Data Blocking in a Move That Might Benefit Many Clinical Pathology Laboratories

CMS wants pathologists and other healthcare providers to report “every issue—small, medium and large,” when someone gets in the way of information sharing

Federal health officials are taking steps to end technology vendors’ “data blocking” practices that inhibit the electronic transfer of patient information. This is a tactic that has proven costly for pathology groups and clinical laboratories that want to interface their laboratory information systems with providers’ or hospitals’ electronic healthcare records (EHRs).

The fiscal year 2015 Omnibus Appropriations Bill passed by Congress in December directed the Office of the National Coordinator for Health Information Technology (ONC) to decertify electronic health record products that are knowingly interfering with the sharing of health information. (more…)

Reliable, High-Quality Clinical Laboratories Continue to Be in Short Supply in Nigeria Despite Efforts to Upgrade Accreditation and Professionalism

Government officials and laboratory scientists urge citizens to ‘patronize only approved medical laboratory facilities and demand quality services’

In Nigeria, government officials and medical laboratory scientists are speaking out about the poor state of medical diagnoses across the country despite their efforts to upgrade accreditation and professionalism of the clinical laboratories that operate in Nigeria.

The widespread call for all medical laboratories to operate according to international standards reflects recognition by patients that they are not getting quality care in the African nation’s clinical laboratories. That is because most operate with obsolete medical laboratory equipment, untrained laboratory staff, and little regulation or government oversight.

“Healthcare providers in developing countries, like ours, lack basic diagnostic tools that would have been taken for granted in developed countries,” declared Olusola Akinniyi, M.B.B.S., Managing Director/CEO of Union Diagnostic and Clinical Services Plc of Nigeria. “In order to achieve the best possible medical outcome, advanced diagnostic examinations need to be applied to diagnose the patient’s underlying health problems precisely.” (more…)

Alert! ICD-10 Conversion Is Now 56 Days Away and Could Put Financial Squeeze on Clinical Laboratories and Pathology Groups

Big question for medical laboratory managers is whether Medicare, private health insurers, and medical claims clearinghouses can make a smooth changeover when processing lab test claims using ICD-10 codes

Conversion to ICD-10 is now only 56 days away! Physicians are not the only ones with a large stake in the conversion from ICD-9 to ICD-10 that takes place October 1, 2015. Clinical laboratories and anatomic pathology groups will be watching to see whether physicians include appropriate ICD-10 codes on lab test forms for Medicare patients.

The Medicare program requires appropriate ICD codes on medical laboratory test claims for Medicare patients. That is one reason why clinical laboratories and anatomic pathology are financially vested in a smooth conversion process. All Medicare Part B claims for medical laboratory tests must be submitted with an appropriate International Classification of Diseases (ICD) code provided by the physician who ordered the lab tests. The Medicare program will not reimburse lab test claims without an appropriate ICD code. No code, no payment to the lab, even though it did the test.

Mark Roth, Physicians Choice Laboratory Service Vice President of Operations, and a speaker at this year’s Dark Report Executive War College, predicts ICD-10 implementation will increase claims denials by 20%.

“People really need to plan ahead for [reduced] cash flows in October and November,” Roth told Dark Daily. “If your Medicare denials go through the roof, all your commercial payer denials are probably going to go through the roof as well. Extending your DSO (Days Sales Outstanding) from 45 to 55 days has a material financial impact.” (more…)

Biotech Entrepreneur Ready to Spend $100 Million to Design Cheap and Easy-to-Use Handheld Ultra-sound Scanners That Can be Used in Drugstores

Radiology poised to be disrupted as entrepreneurs work to create smaller, cheaper imaging devices that perform as well or better than big, expensive imaging systems

Handheld ultra-sound scanners that are as “cheap as a stethoscope” is the goal of a $100 million development project. Just as the clinical laboratory industry is seeing entrepreneurs pour hundreds of millions of dollars into projects intended to create miniature medical laboratory testing devices, so also is radiology and imaging a target for ambitious entrepreneurs.

The vision of biotechnology entrepreneur Jonathan Rothberg, Ph.D. is to have patients take a trip to their neighborhood drugstore rather than an imaging center the next time they need an ultrasound or MRI.

Rothberg is the driving force behind a $100 million startup called Butterfly Network. He hopes to disrupt the status quo in radiology by creating an ultrasound scanner that “is as cheap as a stethoscope” and would allow physicians or other healthcare professionals to do imaging studies using a device not much larger than a smartphone, MIT Technology Review reports. (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…)

Top Biologists Call for Moratorium on Use of CRISPR Gene Editing Tool for Clinical Purposes Because of Concerns about Unresolved Ethical Issues

Most pathologists know that CRISPR can permanently repair DNA to eliminate diseases that plague families, but also could be used for less ethical purposes, say experts

Gene editing is a rapidly developing field that is expected to create new diagnostic needs that can be filled by pathologists and by new medical laboratory tests. However, experts in bio-ethics are voicing concerns that gene editing for clinical purposes is moving forward without proper consideration of important ethical issues and are calling for a moratorium on use of gene editing for clinical purposes.

What is speeding the development of gene editing is use of the tool known as CRISPR/Cas9. It is a gene-editing tool that makes it possible to genetically modify DNA for therapeutic purposes. It provides medical scientists the ability to repair damaged genes that cause or predispose individuals to disease. (more…)

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