Agency heads pitch Congress on public health data

With help from David Lim (@davidalim), Zach Brennan (@ZacharyBrennan) and Mohana Ravindranath (@ravindranize)

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Quick Fix

— Agency heads make data pitch: HHS officials want Congress to make more investments in public health data.

— HHS unified agenda: The department unveils its regulatory plans.

— FDA’s PDF hopes: And the FDA wants to abolish PDFs from one corner of its operation.

eHealth tweet of the day: Laura Lippman @LauraMLippman “#ProTip If you’re doing therapy by phone right now, you can walk slowly around your dining room table and rack up almost 2000 steps in a session.”

WEDNESDAY: Your correspondent hopes everyone’s gearing up for a nice Fourth of July weekend — any grilling plans? Discuss with [email protected]. Share socially @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

THE VACCINE RACE: The world is waiting on a coronavirus vaccine. We’re tracking the global competition, the research and development, the rollout plan and how effective the vaccine will be. Check out our full coverage here.

Driving the Day

AGENCY HEADS MAKE DATA PITCH — HHS’ top officials dealing with the coronavirus once again advocated for an improved data infrastructure, making their pitch at a Senate HELP Committee hearing on Tuesday.

“They really are in need of aggressive modernization,” CDC Director Robert Redfield said in response to a question from Sen. Lisa Murkowski about delays in contact tracing. “There are a number of counties that are still doing this pen and pencil,” he continued. “And we need to have a comprehensive, integrated public health system that’s not only able to do something that’s in real time, but can actually be predictive.” He also praised Congress for its CARES Act funding, which devoted some cash to data modernization.

Testing czar Brett Giroir offered similar comments, noting that the task force didn’t have enough information in the early days of the pandemic. “When we came into this, we didn’t know how many ventilators were in use, how many tests were out there, were the tests positive or negative, or who was being tested,” he said in response to a question from Chair Lamar Alexander.

— And on mental health: In comments ahead of Tuesday’s Energy and Commerce hearing on mental health, the Association for Behavioral Health and Wellness called for permanently removing geographic restrictions on payments for telehealth and adding the home as an originating site, among other policy recommendations. “[M]aking the changes permanent will help address the growing need for behavioral health services,” the group wrote.

HHS UNIFIED AGENDA — The department rolled out its unified agenda on Tuesday, setting out its roadmap for the next few months. Seasoned health IT watchers will find no surprises — we mean this literally; all the items have appeared on previous agendas:

— OCR: The Office for Civil Rights says it’s going to modify HIPAA to support care coordination; and that it’s going to ask about distributing civil monetary penalties gained from settlements or fines with HIPAA violators to victims.

— SAMHSA: The Substance Abuse and Mental Health Services Administration will be modifying its Part 2 rules, given Congress’s work in loosening privacy restrictions for substance use treatment records in clinical contexts.

— OIG: And the Office of Inspector General is planning to revise its safe harbor to Stark and anti-kickback laws to allow more care coordination.

— CMS: The nation’s largest payer will be looking for comments about how to implement its requirements for e-prescription of controlled substances.

FDA’s PDF HOPES — The FDA is transitioning away from using clunky PDF forms in favor of a new digital submission system for clinical trial researchers who submit reports on adverse events, an agency official said at a data modernization conference Tuesday.

Meredith Chuck, acting supervisory associate director for safety in FDA’s office of oncologic diseases, is leading the push for the agency to move from receiving “a sea of PDFs” to structured data submissions that are more easily searchable and sortable.

Currently, drugmakers monitor the safety of their clinical trials and submit serious adverse event reports to the FDA at a rate of about 30,000 to 50,000 PDFs per year, Chuck said. But sometime in the next several years (two years after draft guidance is finalized), the FDA will begin to require the digital submissions to improve data quality and allow FDA officials to more easily sift through the data.

The shift will also mean that clinical trial safety reports will be held in FDA’s adverse event reporting system alongside safety reports submitted to the agency after a drug comes to market, so reviewers can view the data in a structured format and look at how the data changes from the clinical trial to the real-world safety reports. But unlike the postmarket reports, the clinical trial reports will not be public.

The change will also mean that FDA officials can look at subsets of adverse events by outcome or across a drug class, for instance, Chuck added.

Coronavirus

BIDEN CORONAVIRUS PLAN — Presumptive Democratic presidential nominee Joe Biden has a new plan for combatting the coronavirus, and as you’d expect there are a number of health tech tidbits: ramping up sentinel surveillance; establishing a claims code for the virus; building new data dashboards; and implementing telehealth for emergency rooms and ICUs.

DOJ, HHS, FTC PARTNERING TO FIGHT CONTACT TRACING FRAUD — As public health departments across the country work to set up robust contact tracing programs, criminals are trying to take advantage, the Justice Department warned Tuesday.

Scammers are posing as contact tracers and attempting to steal money, Social Security numbers or other personal information.

“You may receive a call, email, text or visit from a contact tracer, and you should not hesitate to talk with them,” said Andrew Smith, director of the FTC’s Bureau of Consumer Protection. “But, beware if they ask you for money, bank account information, your Social Security number, or to click on a link, as those are sure signs of a scam.”

— Convenient timing: This warning comes days after the FBI warned the public Friday that scammers are also pitching fraudulent or unapproved antibody tests for coronavirus in an attempt to steal personal health information.

Telehealth

RURAL CARRIERS PROTEST FCC’S LATEST CRACKDOWN — Rural wireless carriers are “stunned” at the FCC’s speed in cutting off subsidies to U.S. companies using gear from Huawei and ZTE, the Rural Wireless Association said this week. As POLITICO’s John Hendel reports, the FCC announced it would formally designate the two Chinese companies as national security threats.

The trade group said the FCC action “puts rural carriers in a precarious situation” as they juggle the challenges of the coronavirus pandemic and other marketplace squeezes, John writes. The FCC’s proposal would cut subsidies off starting Wednesday; companies are asking FCC for “sufficient time” to request waivers before the subsidies end.

EVIDATION SECURES FUNDING BOOST — Data startup Evidation has brought in a $45 million funding round, the company announced Tuesday.

What We're Reading

The BBC manages to see, real-time, negotiations between UCSF and a ransomware hacker.