HHS extends interoperability comment window

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

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Medicare’s innovation lab will unveil new experiments today as the Trump administration explores value-based care models. More on that later, but first:

—HHS taking more feedback on interoperability: ONC and CMS extended the comment period for their dual health data rule proposals, the second draft of TEFCA is now live, and there’s a new FAQ on HIPAA.

—Will DEA rulemaking delay telemedicine medication-assisted treatment? DEA is working on a rule clarifying when doctors can register to prescribe controlled substances via telemedicine to patients they haven’t met. But the agency’s been mum on the specifics, so doctors might continue to avoid telemedicine medication-assisted treatment for now.

— CMS proposals on SNFs, post-acute care: New proposals include one aiming to track whether post-acute care providers send medication lists to patients’ post-discharge providers.

eHealth Tweet thread of the day on HHS’ new OCR FAQ: Kirk J. Nahra (work) @KirkJNahrawork Replying to @HealthIT_Policy @HHSOCR man, not easy to find though.

Lucia Savage @SavageLucia Retweeted Kirk J. Nahra (work) @HHSOCR You have a Listserve with tens of thousands maybe hundreds of thousands of people’s emails on it. Could you just publish these there?

It’s MONDAY at Morning eHealth. What are you tracking this week? News tips go to [email protected]. Tweet the team at @arthurallen202, @dariustahir, @ravindranize, @POLITICOPro and @Morning_eHealth.

HHS AGREES TO EXTEND INTEROP RULE COMMENT PERIOD — The several health IT groups clamoring for more time to weigh in on the two HHS health data rules had their wish granted Friday, when the department pushed the comment deadline until June 3.

CMS and ONC in February had jointly released two proposed rules, mandated under the 21st Century Cures Act. The CMS proposal pushes insurers to adopt common and open data standards, while ONC’s clarifies exceptions to the information blocking ban outlined in the Cures Act.

Also on Friday, HHS published an updated FAQ about patient data sharing and HIPAA, as well as a second draft of the ONC trusted exchange framework for health data sharing, known as TEFCA. These were part of the justification for pushing the comment deadline.

—What’s in TEFCA 2: ONC nixed a previous proposal that networks support population-level data-sharing. The draft also invited app developers and non-HIPAA users to into the exchanges but maintained that they’d have to comply with HIPAA, eHealth’s Darius writes.

ONC also posted agrant opportunity for a coordinating entity to oversee the “common agreement,” part of TEFCA — the covenant between exchange users. That entity would get $900,000 in the first year.

ONC expects to name that group by Aug. 30; the “common agreement” should be handed over to ONC for approval by Nov. 29. Pros can read more here.

—HHS dinged on cybersecurity: Elsewhere at HHS, a watchdog report finds the department’s efforts to protect sensitive data and networks ineffective. The inspector general’s office audited FDA, CMS, NIH and the Office of the Secretary; among deficiencies were: outdated technology with unsupported security functions and an inability to track the implementation of two-factor authentication. Pros can read more from Darius here.

LINGERING CONFUSION ON DEA’S TELEMEDICINE RULEMAKING—A Drug Enforcement Agency rule expected out in October is supposed to clarify when doctors can register to prescribe controlled substances via telemedicine — a capability that some addiction experts hope can expand access to medication-assisted treatment (MAT) for opioid use disorder.

But experts warn that the DEA rule could disappoint telemedicine MAT advocates. For instance, it’s not clear what will be in the rule, explained Nathaniel Lacktman, chair of Foley & Lardner’s telemedicine team. If the rule isn’t specific enough or if it restricts prescribing to certain specialties or substances, clinicians might not feel comfortable prescribing virtually.
The opioid package signed into law last year gave the DEA a hard deadline for issuing a rule describing when exactly physicians can get exemptions from the 2008 Ryan Haight Act, a federal ban on prescribing controlled substances virtually without an in-person exam.

Until that happens, the status quo remains. Most doctors can’t prescribe substances such as buprenorphine, a controlled substance used for addiction treatment, via telemedicine unless they’ve seen patients in person first.

Trade groups have been weighing in. The American Telemedicine Association, the American Psychiatric Association, and the National Rural Health Association have urged DEA to publish a draft well in advance of the October deadline so the public can comment. They have also suggested not limiting registration to certain specialties, among other recommendations. Pros can read the rest here.

…Also on opioids, the FDA has granted approval to Teva’s generic naloxone nasal spray for treating opioid overdose, our colleague Sarah Karlin-Smith writes. This is the first such generic treatment for people without medical training.

CMS PROPOSALS ON POST-ACUTE DATA — CMS plans to track whether post-acute care providers are sending medication lists to patients’ providers after discharge or transfer, as well as whether the lists are given to patients or their caregivers, Darius writes. The agency proposed these new measures in its skilled nursing facility payment rules last week.

The agency says up to 86 percent of transitions from nursing homes involve inconsistencies in medication lists, which can increase the likelihood of adverse events. Comments are open until June 18, and CMS plans to start collecting data Oct. 1, 2020. More for Pros here.

...CMS has also proposed to raise Medicare payments for skilled nursing facilities by 2.5 percent, about $887 million, in fiscal year 2020, our colleague Rachel Roubein reports.

ON TAP TODAY: NEW PRIMARY CARE PILOTS — HHS plans to unveil new experimental models for paying health care providers as the Trump administration considers value-based care models, Rachel and Dan Diamond report. The new pilots would include measures to test primary care models and a new program that could encourage providers to take on more risk. HHS’ goal is to encourage providers to apply to participate over the summer and launch the program in January.

Part of CMS’ announcement is a new direct contracting model to effectively replace the Next Generation ACO model. Pros can read more here.

GROUPS WARN OF ‘DIGITAL REDLINING’ — Several groups last week pushed Congress to “directly address the civil rights impacts from the exploitation of personal information” in federal privacy legislation, our colleague John Hendel reports.

“Any legislation addressing data practices must recognize and address how the exploitation of personal information can disproportionately harm marginalized communities, including by enabling discrimination—intentionally or unintentionally—against people of color, women, religious minorities, members of the LGBTQ+ community, persons with disabilities, persons living on low income, and immigrants,” groups including Color of Change, Demand Progress, National Urban League and Public Citizen wrote in a letter to leaders of House and Senate commerce panels. They highlighted “digital redlining,” or using demographic data to discriminate online, John writes.

A recent bill from Sen. Catherine Cortez Masto (D-Nev.) aims to stop companies from using consumer data to “discriminate against protected characteristics, including political and religious beliefs.”

—AHRQ’s Gopal Khanna blogs about the usefulness of predictive analytics in health.
—Amitha Kalaichandran writes in Wired about AI predicting death.
—MD Anderson has ousted foreign researchers, Science’s Mara Hvistendahl reports.