Practice Transformation
Real-world evidence drawn from unstructured clinical notes was more accurate than structured data in algorithmic prediction of coronary artery disease, according to research published in the Journal of the American Medical Informatics Association. In other words, real-world data contained in unstructured narratives have significant predictive value when trained algorithms mine it. “In order to maintain credibility and advance science, pharma, academia and vendors must not shy away from the hard work required to ensure data accuracy. As payers and regulatory agencies move forward with real world evidence to overcome cost and generalizability issues, understanding the benefits and limitations of different data and technologies is essential,” the researchers conclude. (Healthcare IT News; JAMIA)
Geisinger reports that its DNA sequencing program identified genetic risks in more than 5,000 people in its first year. One year after beginning to integrate MyCode genomic sequencing data Geisinger Health System reports that 174,500 of its patients have provided genetic samples for sequencing. MyCode began as a research program. Last year, the system announced MyCode data would also be used in routine preventive care. So far, 1,181 patients have been found to have genetic variants that could lead to health conditions. After factoring in close relatives at risk for the same genetic variant, Geisinger determined that more than 5,000 patients have learned of their genetic risk. (Becker’s Hospital Review; MyCode Scorecard)
Evidence & Innovation
A small company, Tremeau Pharmaceuticals, wants to bring back the arthritis drug Vioxx–but this time for hemophilia patients. Vioxx was recalled in 2004 for leading to roughly 60,000 deaths. Tremeau is developing a generic version of Vioxx as a treatment for severe joint pain in patients with hemophilia. According to STAT, some medical experts maintain the drug should return to the market; before the recall, it was the drug of choice to treat hemophilic arthropathy. (STAT)
Doctors, for the first time in the U.S., have used the gene-editing tool CRISPR in people with cancer. “It’s the most complicated genetic, cellular engineering that’s been attempted so far,” said the study leader, Dr. Edward Stadtmauer of the University of Pennsylvania in Philadelphia. “This is proof that we can safely do gene editing of these cells.” However, the test was only to assess safety; it’s too soon to know whether it will affect survival. (Associated Press)
Policy Solutions
A task force assembled by the FDA explored the root causes of drug shortages. It identified three: lack of incentives for drug makers to produce less-profitable drugs, failure to reward–or even recognize–quality production systems and regulatory and logistical challenges that make it difficult to recover from a disruption. The conclusion is far from optimistic: “Given the potential scale of impacts from drug shortages, and the fact that these impacts have continually been underestimated, it is likely that drug shortages will continue to persist absent major changes to this marketplace.” (report; Becker’s Hospital Review)
Medicare will reimburse hospitals and health systems for more remote patient monitoring services, according to the CMS final rule on Chronic Care Remote Physiologic Monitoring. CMS has expanded the reimbursement plateau for remote patient monitoring services delivered “incident to” general supervision, and has added a new code–99458–for patients receiving an additional 20 minutes of mHealth services in a given month. The two changes were among the mHealth and telehealth amendments proposed in August for the 2020 Physician Fee Schedule. However, CMS is preventing federally qualified health centers and rural health centers from billing for RPM services. (mHealth Intelligence; final rule)
