News Trends Analysis

Feb. 16, 2014


Laboratories excluded from EHR donation anti-kickback statute safe harbor and Stark exception. In what the College of American Pathologists (CAP) and other laboratory stakeholders are calling a significant victory for laboratories, pathologists, and patients, the Office of Inspector General (OIG) and the Centers for Medicare and Medicaid Services (CMS) released their final rulings on Dec. 23 regarding electronic health record (EHR) donations and the anti-kickback statute safe harbor and Stark exception. The rules, which became effective January 1, extend the safe harbor/exception through 2021, but exclude “laboratory companies” from the types of entities that may donate EHR items and services. They also clarify the existing prohibition on any action that limits or restricts the use, compatibility, or interoperability of donated items or service.

George F. Kwass, MD, FCAP, chair of CAP’s Council on Government and Professional Affairs, expressed satisfaction that “referral decisions can no longer be premised on the highest EHR donation offers and that patients will have access to laboratories which referring physicians have chosen based on the quality and service rather than an EHR donation. While prohibited under the rules, these donations in practice were indeed quid pro quo arrangements for referrals.”


Loss of function of a single gene linked to diabetes in mice. Researchers from the University of Illinois at Chicago College of Medicine have found that dysfunction in a single gene in mice causes fasting hyperglycemia, one of the major symptoms of type 2 diabetes. Their findings were reported online in the journal Diabetes.

If a gene called MADD is not functioning properly, insulin is not released into the bloodstream to regulate blood sugar levels, says Bellur S. Prabhakar, PhD, lead author of the study. Prabhakar and his colleagues developed a mouse model in which the MADD gene was deleted from the insulin-producing beta cells. All such mice had elevated blood glucose levels, which the researchers found was due to insufficient release of insulin. The finding shows that type 2 diabetes can be directly caused by the loss of a properly functioning MADD gene alone.


Response Database Initiative and Load Zero Foundation join to improve HIV management in resource-limited countries. The Response Database Initiative (RDI) and the Load Zero Foundation are partnering to bring HIV viral load testing and treatment response prediction to poorer countries. Viral load testing will enable physicians to detect HIV treatment failure early, avoiding drug resistance or disease progression. It will also enable physicians to use the RDI’s free online HIV Treatment Response Prediction System (HIV-TRePS) to select the optimal next combination of drugs.

In developed countries the standard of care is the amount of HIV in the bloodstream. The viral load is tested every few months, enabling drugs to be switched as soon as they stop suppressing the virus. In resource-limited nations, viral load tests have been unaffordable, so doctors have had to wait until the patient showed clinical or immunological signs of disease progression before switching. The Load Zero Foundation is funding the provision of tests for such settings to support the shift to viral load monitoring.

Following treatment failure, physicians in developed countries use a genotypic resistance test to help select the best drugs to use next. This identifies where the genetic code of HIV has mutated and to which drugs it may be resistant and sensitive.  Genotyping is also unaffordable in most resource-limited countries. HIV-TRePS uses computer models that have been trained with treatment outcome data from tens of thousands of patients treated in hospitals worldwide.


Reader feedback received. In the January 2014 issue, page 11, in a Continuing Education article, a lab leader offers the opinion that, the increasing automation of today’s Hematology lab notwithstanding, “hematology specialists will still be needed to review cell morphology and release results on samples with abnormal or immature cells.” The editor asked parenthetically if readers who work in Hematology agreed or disagreed.  Reader Connard Rasmussen BA,H(ASCP),GS(ABB), provided this feedback: “YES! For now, specialists like me who have worked in Hematology will be needed by reference labs, Hematology and Oncology practices, and some neonatologists to perform manual differentials and enumerate immature cells for new diagnosis and treatment follow-up. Hematology specialists can triage out the few cases that need to be passed on to a pathologist for review. If funding is available, perhaps in another two decades, all labs will have automation in Hematology that will eliminate the need to hire a person to review manual differentials.” We thank Mr. Rasmussen for his perspective.

Worth Re-quoting

MLO introduces a new feature. On his daily broadcasts, the late radio commentator Paul Harvey (1918-2009) used to have a feature he called “Today’s Quote Worth Re-quoting.” He would present a quotation from the day’s news that he thought bore repeating. This month the editors of MLO introduce a new section in the Observatory along the same lines: we will draw your attention to a sentence or two from the current issue that we believe is particularly valuable as a conversation starter. So here’s this month’s Quote Worth Re-quoting, from the Executive Snapshot article (page 36). Dr. Matthias Herkert, Managing Director, Research and Development, DRG International, says, “So the concept of personalized medicine becomes more and more a reality.” Agree? Disagree? Respond? We invite reactions from readers..