FDA warns against using sketchy diabetes devices

With help from Darius Tahir (@dariustahir)

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Quick Fix

Several industry players will venture to the Hill Tuesday for a hearing on surprise billing, and the federal advisory committee guiding ONC on health data will continue talks Wednesday. Here’s what else we’re tracking:

— FDA warns against using sketchy diabetes devices: An agency safety communication says patients should watch out for unapproved continuous glucose monitoring systems, insulin pumps and other diabetes management devices.

— Amazon venture Haven loses its #2 leader: Chief operating officer Jack Stoddard has left the company after just about nine months on the job.

— Industry group begs ONC and CMS to take time with rules: CHIME weighed in on the dual interoperability and information blocking rule proposals those agencies dropped in February.

eHealth Tweet of the day:: François Chollet on artificial intelligence and machine learning @fchollet There is an ongoing misconception that AI/ML are intrinsically valuable, and that therefore working in the field is bound to make you rich.

A ML model is only as valuable as the problem it solves. ML without an application isn’t worth anything (beyond intellectual curiosity).

IT’S MONDAY AT MORNING EHEALTH. What’s on tap this week? Tips go to [email protected]. Reach the rest of the team at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

Driving the Day

WATCH OUT FOR UNAPPROVED DIABETES DEVICES — Unauthorized diabetes management technology could lead to unsafe glucose dosing or even death, the FDA said in a new safety communication last week. The agency warned patients to watch out for illegally marketed continuous glucose monitoring systems or insulin pumps, and to avoid integrating unapproved components into their diabetes management systems. It’s part of FDA’s efforts to “communicate with the public when we become aware of issues stemming from the use, or misuse, of medical devices,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a release.

HAVEN COO OUT — Jack Stoddard, formerly chief operating officer of the Amazon, Berkshire Hathaway and JP Morgan Chase health technology venture, has left Haven for personal reasons, CNBC’s Chrissy Farr reports. He was previously Comcast’s general manager for digital health. Stoddard was second in command to Atul Gawande, who was named CEO of that venture last June. Stoddard’s departure has raised concern among business experts who say it reflects instability at the new venture, Stat’s Casey Ross and Kate Sheridan report.

CHIME TO CMS AND ONC: GET THE TIMING RIGHT — The College of Healthcare Information Management Executives says CMS and ONC should take their time developing rules they’ve proposed on interoperability and information blocking. In comments, the trade group urged the agencies to publish interim final rules to give the public more time to comment. And once the final rules are out, CHIME wrote, ONC and CMS should ensure that health groups have adequate time to implement them.

ONC should give providers 36 months to absorb changes from updates to certified technology, CHIME said in comments; CMS should allow the the same amount for providers to update their admission, discharge and transition updates.

PENCE MAKES AN IMPRINT ON HHS — Vice President Mike Pence has made his mark on the Health and Human Services Department, an agency that can further one of his key policy goals: de-funding Planned Parenthood, our colleagues Rachana Pradhan and Alice Miranda Ollstein report. Several top leaders including Secretary Alex Azar, Surgeon General Jerome Adams and CMS head Seema Verma have ties to Pence and Indiana, they write. Pence has “clearly recruited people connected to him who share his very extreme views on sexual and reproductive health care,” Emily Stewart, the vice president of public policy at Planned Parenthood, told POLITICO. “This has been one of the most active administrations ever on rolling back reproductive rights and there’s no way that happens unless you have people in the White House driving the effort to put out policies at such a rapid clip.”

Technology

SANDBERG SAYS BREAKING UP FACEBOOK WON’T ACTUALLY SOLVE ANYTHING — Facebook Chief Operating Officer Sheryl Sandberg says the growing calls to break up the social media giant won’t solve underlying problems, our POLITICO colleagues report. “You could break us up, you could break other tech companies up, but you actually don’t address the underlying issues people are concerned about,” including election interference, harmful content and privacy, she said in an interview last week on CBNC.

...Some of the criticism Facebook has received for its privacy practices comes from patients who use the platform to connect with others with the same health conditions. One group filed a major complaint with the FTC alleging that group privacy settings could divulge sensitive information about users’ health status. (Pros can read that story, from February, here.)

Names in the News

TOP MEDICAID OFFICIAL OUT — Chris Traylor, a top Medicaid official who previously led Texas’ $40 billion health agency, is leaving CMS at the end of the month, Rachana reports. Traylor’s departure is the latest in a spate of losses for the agency — at least six people have left CMS’ Medicaid office since the beginning of the year. Traylor joined less than a year ago as deputy administrator for strategic initiatives, overseeing policies including electronic health record interoperability. He was soon moved to lead CMS’ Medicaid division after its then-director, Mary Mayhew, resigned to become Florida’s health secretary. Other departures include Deidre Gifford, a former senior Medicaid division official who was moved to the Innovation Center earlier this year.

Happening This Week

The House Ways and Means Health Subcommittee plans to call witnesses from The ERISA Industry Committee, American Hospital Association, America’s Health Insurance Plans, and the American Medical Association to a hearing on surprise billing Tuesday...HITAC’s full committee discussion is scheduled for Wednesday, and the Trusted Exchange Framework task force convenes Thursday and Friday....

What We're Reading

— WSJ’s Khadeeja Safdar and Inti Pacheco do a deep dive into the net promoter score, a measure of customer satisfaction.

— Business Insiders’Erin Brodwin and Emma Court report on continuing troubles at uBiome, the microbiome testing startup.

— Stat’s Megan Thielking writes that mental health care accounts for a growing chunk of private insurance claims.