Telemedicine’s ‘big day’

With help from Arthur Allen (@arthurallen202) and Darius Tahir (@dariustahir)

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TELEMEDICINE’S ‘BIG DAY’: The final rules CMS released this week could advance virtual treatment further and faster than anything the government has done previously, advocates believe.

On Thursday, the agency finalized plans to reimburse physicians for virtually checking in with patients and remotely evaluating recorded images.

The final Medicare physician payment rule also expands payment for treatments for stroke, kidney disease, mental health and substance abuse by removing restrictions on originating sites. Those are all provisions from the budget and opioid packages. (Pros can read the rest of that story here.)

“Pretty historical decisions,” says Sylvia Trujillo, senior Washington counsel at the American Medical Association. “It is a big day.”

Trujillo spoke at the annual meeting of the Patient Centered Outcomes Research Institute on a panel where doctors presented evidence from two PCORI-funded studies on telemedcine. April Armstrong, a USC dermatologist, presented results showing that people treated remotely for psoriasis did just as well as those treated in person — and were much happier about not having to travel to see their doctors.

Psychiatrist Dror Ben-Zeev of the University of Washington presented a study he led in Chicago that found indigent patients were more likely to participate in mobile-provided therapy than to attend a group session. Those who did participate in both groups ended up with similar outcomes in terms of psychiatric improvement, Ben-Zeev said.

Thursday’s rule follows on the heels of a Wednesday CMS rule making it easier for home health agencies to get paid for remote monitoring of patients.

eHealth Tweet of the day: AfternoonNapper @AfternoonNapper Lobbing a small grenade into the #PCORI2018 discussion: is there anyone who is advocating AGAINST patient-involvement, patient-centered outcomes? Why are we still having to prove this stuff works? Why haven’t we just adopted this as standard by now? When will the mandate come?

It’s FRIDAY at Morning eHealth. Your author’s reporting has been stymied this week by small medical practices that lack an email option for general inquiries — not even one that shoutingly advises patients against transmitting personal health information. Is this simply to discourage HIPAA violations, or because clinicians have no time to check nagging inquiries from journalists? Or patients? Theories and newsy tidbits go to [email protected]. Sound off socially at @ravindranize, @arthurallen202, @dariustahir, @POLITICOPro, @Morning_eHealth.

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... And now back to Thursday’s Medicare payment overhaul, which CMS scaled back from its initial proposal after receiving fierce backlash from doctors, our colleague Rachel Roubein reports.

Over the summer, CMS had proposed shrinking the number of “evaluation and management” codes for office and outpatient visits, which determine Medicare billing, from five levels to two. While doctors applauded the effort to reduce their administrative burden, many warned it would slash their payment for treating complex patients — so the version released Thursday preserves the billing code for the most complex patients and collapses the coding system into three tiers starting in 2021. Pros can read that story here.

.. .elsewhere in the Thursday evening news dump, CMS finalized most of its proposed changes to the health IT sections of the MIPS program, Morning eHealth’s Darius Tahir reports.

The changes are intended to streamline documentation and reporting requirements for clinicians that grew out of the meaningful use program. Under the scoring system, physicians must demonstrate their commitment to information sharing by submitting data to entities like public health agencies and other doctors. Pros can read more from Darius here.

APPLE WATCH HEART STUDY TOPS 400,000 ENROLLEES: Stanford Medicine and Apple could know as soon as next year whether smart watches and optical sensors are viable screens for irregular heart rhythms, the two announced Thursday.

At 400,000 participants — enrollment is now closed — the so-called Apple Heart Study is reportedly the largest study on atrial fibrillation ever conducted, and certainly the fastest for a trial of its size — it launched one year ago and could be finished in the next 12 months.

The findings could “provide a foundation for how wearable technology can inform the clinical approach to AF identification and screening,” reads a paper in the American Heart Journal.

As critics point out, there are dangers associated with mass screening, including misdiagnosis and false positives; one of the study’s lead researchers told WIRED that the team plans to track how patients respond to alerts, and whether they seek followup treatment.

A BOOST FOR PCORI? PCORI — the $6 billion comparative effectiveness group that’s up for reauthorization next year — got a shot in the arm from a former GOP Doctor Caucus member.

Lobbyist Phil Gingrey, the former Georgia congressman, said he’d be joining Tony Coelho, the former Democratic congressman from California, to push for new funds for PCORI. Since becoming a lobbyist for the District Policy Group after leaving office in 2015, Gingrey has softened his stance on parts of Obamacare, which funded 10 years of research through the Patient-Centered Outcomes Research Institute.

Back in 2010, Gingrey said PCORI could end up functioning like European agencies that weigh whether government health agencies should pay for different drugs or procedures. But PCORI was sited outside of HHS and its charter expressly does not address health care costs, only efficacy.

“I hated the ACA and I hated PCORI, but I have to say I’m very comfortable today that PCORI has fulfilled and continues to fulfill its mission,” said Gingrey, a former ob-gyn, in a panel with Coelho. PCORI spokeswoman Christine Stencel said Gingrey, who lobbies for various provider and research groups, had no direct relationship with the institute.

REPORT VA EHR UPGRADE “TRENDING TOWARDS RED”: A recent progress report from Cerner on its VA EHR modernization project called its alert level “yellow trending towards red,” ProPublica’s Isaac Arnsdorf, formerly at POLITICO, reports. That’s not a good sign for the $10 billion project, recently under scrutiny from lawmakers for a variety of reasons, not least because of the influence of three individuals associated with President Donald Trump’s Mar-a-Lago resort. Arnsdorf reports that the White House and Trump’s associates have interfered with the hiring of a qualified leader for the tech upgrade, and that current leaders have no health care experience.

OIG CONTINUES FOCUS ON FDA’S CYBER WORK: FDA’s monitoring of devices for cybersecurity problems was lacking, a new report by HHS’s Office of Inspector General argues. The report, based on fieldwork conducted between September 2016 and February 2017, states that the agency needs to do a better job ensuring devices already on the market are well-defended against digital intrusion.

Much of the report’s criticisms are based on historical information, and the agency claims it’s addressed many of the faults. FDA recently embarked on a spate of cybersecurity activity, including issuing new guidance and inking a memorandum of understanding with DHS and other cyber organizations.

A September OIG report urged FDA to do more to check devices’ digital defenses during the pre-market phase.

WYDEN DRAFT BILL COULD SEND TECH EXECS TO PRISON: Draft legislation from Sen. Ron Wyden would beef up the Federal Trade Commission’s power to police tech companies’ privacy practices — and subject senior executives to criminal penalties for breaking the rules, our colleague Ashley Gold reports.

Wyden’s Consumer Data Protection Act of 2018 applies to companies with at least a million users that generate at least $50 million in annual revenue. It would create a national Do Not Track registry to let Americans stop tech companies from collecting and sharing their data. Under the draft bill, the FTC would maintain a website for that registry where people could view or change their opt-out status.

Wyden also proposes letting sites like Facebook and Google offer paid versions of their services that don’t collect data, as long as they don’t charge more than they would have made from data-driven targeted advertising.

The measure would direct the FTC to establish cybersecurity and privacy standards for tech companies to follow. Companies would then have to submit an annual report on their compliance with the act and ensuing FTC rules. Misleading the agency on that report could send top executives to prison for up to 20 years.

NIH RE-OPENS GENOMIC SUMMARY DATA: NIH on Thursday announced that it would again allow unrestricted research access to genomic summary results for most NIH-funded research. The summary results do not include individual-level information, Human Genome Research Institute Director Eric Green said in a blog post.

They come from analyzing pooled genomic data to generate a statistical result for the entire dataset, providing potentially powerful tools to help figure out which genomic variants contribute to diseases.

… NIH had removed the summary results from unrestricted access after researchers raised concerns in 2008 that general access could lead to privacy violations. But after study, NIH determined that the benefits of sharing the summary data far outweighed the risks. Certain study data may still be restricted if there is a risk of it leading to privacy violations.

ICYMI ATHENAHEALTH WATCH: Activist investor Elliott Management and Veritas Capital are nearing an acquisition agreement with athenahealth, Bloomberg reports, noting that negotiations are ongoing. A new report from KLAS Research found a sharp drop in potential customers for athenahealth over the last 12 months, though 83 percent of current customers plan to stay with the company long-term.

—Hair loss and ED company Hims is launching a birth control arm called Hers, Forbes reports

—Mark Segal’s blog in HealthDataManagement on linking policy to health IT

—CNBC reports on the strategy behind DNA sequencing company Illumina’s $1.2 billion Pacific Biosciences acquisition

—Experts make snap judgments on the merits of “human-level AI” at Futurism