FHI's Week in Review

Volume IV, Issue 15

April 10, 2017

FDA allows marketing of first direct-to-consumer tests that provide genetic risk information for certain conditions

According to an FDA.gov news release dated 4.6.17:

The U.S. Food and Drug Administration (FDA) today allowed marketing o f 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual's genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.

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"Consumers can now have direct access to certain genetic risk information," said Jeffrey Shuren, MD, Director of the FDA's Center for Devices and Radiological Health. "But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won't ultimately develop a disease."

"This is an important moment for people who want to know their genetic health risks and be more proactive about their health," said Anne Wojcicki, 23andMe CEO and Co-Founder. "The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics."

What healthcare leaders can expect after AHCA's demise

Kent Bottles, a lecturer at the Thomas Jefferson University School of Population Health and Chief Medical Officer of PYA Analytics, in an Apr 5, 2017 Fierce Healthcare op-ed, offers salient advice to healthcare leaders and a plausible forecast in an uncertain environment.

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Among Mr. Bottles insights are the following:

A bipartisan approach to improving the ACA does not seem likely
Hospital and physician leaders should plan for the ACA to continue to be the law of the land, and they should recognize that the Republican administration will continue to oppose it
The Trump administration can undermine the ACA without Congress passing any new laws.
They should be ready to deal with the fallout of unstable state insurance exchanges if the administration does not do enough to reassure insurers

Electronic Health Record Logs Indicate That Physicians Split Time Evenly Between Seeing Patients And Desktop Medicine

An early April Health Affairs post examines how physicians are spending their time. Over thirty-one million EHR transactions in the period 2011-14, recorded by 471 primary care physicians, were captured. Results suggest that the physicians logged an average of 3.08 hours on office visits and 3.17 hours on desktop medicine each day.

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According to study authors Ming Tai-Seale, Cliff W. Olson, Jinnan Li, Albert S. Chan, Criss Morikawa, Meg Durbin Wei Wang and Harold S. Luft:

Time spent by physicians is a key resource in health care delivery
Over time, log records from physicians showed a decline in the time allocated to face-to-face visits, accompanied by an increase in time allocated to desktop medicine
Staffing and scheduling in the physician's office, as well as provider payment models for primary care practice, should account for these desktop medicine efforts