Cures 2.0: Just a pipe dream?

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

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Quick Fix

Quite a buzzy few days for eHealth, perhaps appropriately coinciding with National Health IT Week. Here’s the rundown:

— Cures 2.0: Just a pipe dream? Reps. Fred Upton (R-Mich.) and Diana DeGette (D-Colo.) are working on a health-focused bill that lobbyists hope involves interoperability.

— VA’s Cerner rollout stalls: The department confirmed it’s putting off the bulk of its initial EHR implementation for more training and development.

— Biden’s brother name drops Cancer Initiative in investment pitch: James Biden told executives recently that his brother’s cancer program could promote their business.

eHealth tweet of the day: Atul Butte, @atulbutte, “I think payers are remarkably good at figuring out what they don’t (or shouldn’t) want to pay for, using modeling and #AI. I think a new role for academic med centers is to use data and #AI to defend the care provided. #CHIP25"

It’s FRIDAY at Morning eHealth where your author is intrigued by a proposed AI application that would complete users’ rough sketches. (Now if only it could also complete her rough drafts... h/t VentureBeat’s Kyle Wiggers.) Tips go to [email protected]. Tweet us at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

Driving the Day

UPTON, DEGETTE IN LISTENING STAGES OF CURES REVAMP — The bipartisan duo are crafting a second iteration of the 21st Century Cures Act, Sarah Karlin-Smith and Arthur Allen report. During an Energy and Commerce subcommittee hearing on drug pricing this week, Upton said he and DeGette were gathering input on how to make Cures work better.

...A potential Cures 2.0 — and rumored interoperability-themed provisions — drew the Strategic Health Information Exchange Collaborative fly-in participants to Capitol Hill. But the Health Innovation Alliance’s Joel White told Morning eHealth it could be pipe dream. “How does drug pricing or appropriations get done post-impeachment?”

..."Seems like if they want to do interoperability as a core element, and we don’t have final rule on interoperability, a bill seems premature,” he added.

MARCH, OCTOBER TARGETED FOR VA CERNER IMPLEMENTATION — The department this week confirmed its plans to delay the Cerner EHR rollout in the Pacific Northwest. While the Mann-Grandstaff VA Medical Center in Spokane is scheduled to implement the EHR in March, the VA hospital system in Seattle and Tacoma needs more time and will go live in October 2020, said Laura Kroupa, chief medical officer on the project. Kroupa made the remarks during a House Veterans’ Affairs Technology Modernization Subcommittee hearing on Cerner.

..."Critics have questioned the decision to move forward at the Spokane facility, which is understaffed, overcrowded and has infrastructure problems,” Arthur writes. “A kitchen located over the data center has been leaking fluid onto servers beneath it, officials acknowledged at the hearing.”

BIDEN CANCER INITIATIVE CONNECTION SWEETENS BROTHER’S PITCH — James Biden told executives at a health care firm that the Biden Cancer Initiative would promote their oral rinse, made by the firm and used by cancer patients, our POLITICO colleague Ben Schreckinger reports. He made the promise on behalf of potential investors, according to a participant in the conversation. “The allegation is the latest of many times Biden’s relatives have invoked the former vice president and his political clout to further their private business dealings,” Ben writes. A spokesperson for James Biden disputed the account.

HOUSE PASSES MEDICAL SCREENING BILL — The House passed a Democratic bill this week that would improve medical screening of migrants in Customs and Border Protection custody by creating a DHS electronic health record system, our POLITICO colleague Eleanor Mueller reports.

PAUL BILL MAINTAINS FAMILY BATTLE TO STOP PATIENT IDs — Sen. Rand Paul is continuing a family tradition: trying to stop the government from developing a national patient identifier. Paul on Wednesday introduced a bill that would strike at HIPAA, which allows the government to develop an ID. Previously, Paul’s father, Ron Paul, had stopped the development by using a provision of an annual appropriations bill. That provision has stood for 20 years. However, the House passed an amendment that would strike down the funding ban; even though the Senate has shown little interest in following that lead, Paul is nevertheless introducing the bill.

FDA PUTS OUT NEW DECISION SUPPORT GUIDANCE — The agency on Thursday released a long-awaited guidance on decision support software. The document is a response to critiques from a previous edition in December 2017, the agency’s digital health lead, Bakul Patel, told Darius.

...Those critiques included confusion about the distinction between decision support software for clinicians, and that of patients. That lead the FDA to create tiered standards for oversight, based on whether the intended user of the software is a health care provider, and whether the output of the software is reviewable by its user. Products whose output isn’t reviewable, or whose user isn’t a doctor, will get higher levels of scrutiny.

“This is progress, albeit maybe smaller steps than it might otherwise appear,” Epstein, Becker and Green lawyer Bradley Merrill Thompson told us. Thompson, who advises decision support software firms, said while he appreciated the FDA’s decision to explicitly tailor its oversight capabilities to each product’s level of risk, he believes the agency still overregulating certain low-risk products targeting non-serious conditions. In some cases, it will still have oversight responsibilities.

NEW CMS OFFICE — The agency is setting up an office of burden reduction focused on removing administrative clutter from health care providers’ lives, Darius reports. CMS Administrator Seema Verma also said the burden reduction rule issued this week, which included 30 small rule changes, would save providers an estimated $843 million in its first year.

Research Corner

SECRET SHOPPERS INFILTRATE BIRTH CONTROL SITES — Researchers say it’s just as safe to get birth control pills via apps or websites as it is to receive them through in-person clinics — at least, according to their assessment of seven secret shoppers’ experiences with Planned Parenthood, Nurx, Prjkt Ruby, Virtuwell, Lemonaid, The Pill Club, Pandia Health, HeyDoctor, and MAVEN. They described the findings in a letter to the New England Journal of Medicine’s editor.

...Clinicians on those sites adhered to CDC guidelines for oral contraceptive prescriptions in 93 percent of cases in which patients presented a medical risk. Researchers compared those results with a study that found 14 percent of woman who got birth control pills from clinics in Texas presented at least one risk factor.

“The quality we’re seeing there is reasonable, in the sense that the vast majority of the time they picked up the [risk factor], and they treated the women appropriately,” said Harvard’s Ateev Mehrotra, one of the researchers.

Lobby Watch

AMA CRITICIZES PART 2 RULE ON LAW ENFORCEMENT — Back in August, HHS rolled out a pair of rules changing 42 CFR Part 2, the 1970s-vintage rule governing the confidentiality of substance use treatment records. Health care groups want to reform the regulation, which is intended to protect patients from stigma or legal action, arguing it impedes care coordination for patients.

...One of HHS’ rules dealt with confidentiality in clinical contexts, while the other focused on policing. There the department has decided to make records more accessible to law enforcement, dropping a phrase that restricted officials’ access to crimes committed by the patient.

In a letter submitted on the last day of comment on the second rule, American Medical Association President James Madara wrote that the change give “the ability to use patient records to investigate criminal activity that does not involve the patient,” apparently with the purpose of enabling investigations of alleged pill mills and rogue doctors. It does so without providing any evidence that Part 2 inhibits law enforcement work, or that the change addresses a serious problem, Madara said in the letter.

Names in the News

CMMI’s Adam Boehler is confirmed as U.S. International Development Finance Corporation CEO... Juul’s CEO has stepped down as the company promises not to lobby the Trump administration on a looming ban on flavored vapor products.

What We're Reading

— 23andMe is getting into clinical trial recruitment, Stat’s Rebecca Robbins reports.

— KFF’s 2019 Employer Health Benefits Survey finds that among firms offering health benefits, 11 percent gather data from employees’ mobile apps and wearable devices as part of wellness or health programs.

— The Defense Health Agency is looking for vendors to help consolidate the military’s health IT, Nextgov’s Aaron Boyd writes.