DOJ Pursues Organizations That Falsely Claim Compliance with Medicare’s EHR Incentive Programs

Clinical laboratories that interface with hospital EHR systems under scrutiny by the DOJ could be drawn into the investigations Officials at the federal US Department of Justice (DOJ) continue to pursue fraud cases involving health systems that allegedly have falsely attested to complying with the Medicare and Medicaid electronic health record (EHR) adoption incentive programs (now known as the Promoting Interoperability Programs). This is important for clinical laboratory leaders to watch,...

New FDA Regulations of Clinical Decision-Support/Digital Health Applications and Medical Software Has Consequences for Medical Laboratories

Softened FDA regulation of both clinical-decision-support and patient-decision-support software applications could present opportunities for clinical laboratory developers of such tools Late 2017, the Food and Drug Administration (FDA) released guidelines on how the agency intends to regulate—or not regulate—digital health, clinical-decision-support (CDS), and patient-decision-support (PDS) software applications. The increased/decreased oversight of the development of these physicians’ tools...

ONC Releases Final Rule for Stage 3 Meaningful Use: What Most Affects Clinical Laboratories and Anatomic Pathology Groups

Meaningful Use Stage 3 focuses on interoperability, which is good news for medical laboratories that must spend time and money to develop effective LIS-EHR interfaces On December 15, 2015, the final rule for Stage 3 meaningful use (MU) went into effect. By now, pathologists and clinical laboratory managers and personnel are well-acquainted with the MU incentive program and the myriad of challenges it presents for almost everyone working in the healthcare sector. Although the implementation of...

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...

Obama’s $215 Million Precision Medicine Initiative: Will Congress Fund It and Can It Advance Genetic Testing and the Value of Clinical Laboratory Services?

As proposed, the President’s Precision Medicine Initiative would incorporate a large, volunteer study cohort in innovative ways Even as a new presidential initiative to boost precision medicine makes headlines, there is uncertainty as to how the program can be funded. The Precision Medicine Initiative was announced by President Obama on January 30, 2015. Many pathologists, clinical chemists, and medical laboratory scientists recognize that such a program would pump additional funds into the...
;