Letter from Washington: ‘Exceptions’ and threats to bookend data blocking regulation

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Aug 14, 2018

Washington, D.C. - There was a lot of tough talk around data blocking and the federal government’s proposed regulation during ONC’s interoperability forum August 6 to 8 in Washington, D.C.

CMS Administrator Seema Verma said that data blocking under the guise of patient data security is a “ruse” and amounts to “patient profiteering,” financially driven by systems that don’t want to share data toward keeping patients within a given health system.

ONC’s policy lead Elise Anthony later noted that “data hoarding” is a “commonplace default” within delivery systems, and that ONC regularly receives reports of data blocking.

Data blocking fines, penalties and TEFCA

The data blocking proposed rule is to carry with it per-incident fines of up to $1 million, decertification and other penalties, all provided for in the 21st Century Cures law.

But what’s tempering the tough talk is news from ONC that the proposed rule will include “exceptions” language to data blocking incidents. What this means is data sharing circumstances you got caught up in that might lead to an exception. This is akin to safe harbor, but that more legal term won’t be prescribed around the language. Do expect though umbrella safe harbor intimations from data blocking via participation in ONC’s other policy track the Trusted Exchange Framework and Common Agreement (TEFCA). TEFCA is the new voluntary structure for national exchange while data blocking is the stick.

Both are expected in tandem in September. TEFCA has already gone through its proposed rule and comment phase, with updates coming with the first proposed rule for blocking.

Also announced in D.C. was that anti-data blocker attestation will remain in year three of the MIPS quality reporting system within MACRA, or the Quality Payment Program (QPP) as CMS now likes to call it.

New white paper provides the details

All of this is detailed in our new white paper, Are You a Data Blocker? How to Fit into ONC’s New Interoperability Framework and Regulation.

And all of this amid some doubts as to whether ONC can rightly shepherd these processes. Why? The agency’s deputy director leading TEFCA was moved to the VA to oversee EHR adoption there, and rightly so, ONC’s budget has taken a hit within HHS and due to the time lag of the entire TEFCA/blocking process.

Those fears though should prove unfounded, and really it’s the health IT industry’s support for TEFCA and blocking that should see it through, not just through cheerleading but through the CommonWell Health Alliance, Sequoia Project/e Health Exchange/Carequality and other existing national networks playing very structured roles.

What ONC is getting at are the data management agreements between a system and an HIE, for example, closed EHR networks and other bureaucracies impeding data flow it wants to eliminate through TEFCA.

And then of course, there’s CMS.

The archaeology of CMS

If you’ve been following the agency recently, and who hasn’t, CMS is putting its own related stamp on interoperability where it counts, financially.

Through its inpatient payment rule, outpatient payment rule, SNF and post-acute care rules, for example, CMS has included RFIs or related language looking to also shore up data exchange along with quality reporting.

The trick is to connect the dots. Is the inpatient rule on providing post-discharge patient records via the API/app of their choice related to the outpatient rule setting up post-discharge site neutrality for clinic visits outside of hospital-owned clinics? Along with less fees for the hospital-owned clinics? It aligns with CMS rhetoric on patient-centered structures and more free-flowing data.

Or as Verma put it back in D.C., CMS is “taking the lead role in API.” Is that a message to ONC also?

This aggressive approach to Medicare payments followed the close of the ONC forum when CMS issued its Medicare ACO proposed rule.

CMS pushes risk for ACOs

Just one day after the forum, CMS issued its Medicare ACO proposed rule, making good on its own threats to do so in April.

The proposed rule, with comment due October 16, followed by a final rule, reduces the time allowed for ACOs to operate in an upside risk only structure from six to two years.

Also, financial rewards would fall from 50 percent to 25 percent while operating in a no-risk level. This is to push ACOs into a risk-bearing level, two-sided or downside risk. And many are doing so today. CMS added a perk to those within the Next Generation ACOs by adding telehealth originating site waivers for dermatology and ophthalmology.

That tide is already turning as into the 2019 Physician Fee Schedule proposed rule, CMS is implementing aspects of February’s Bipartisan Budget Act that expands telehealth for ESRD and stroke. The fee schedule goes further with other telehealth expansions though still bound by originating site until Congress and other Congressional bills further decrease originating site. The fee schedule also expands remote patient monitoring and introduces new codes for virtual check-ins and imaging movement.

The ACO proposed rule also mandates the use of the 2015 Edition of ONC certification, also seen in other of this summer’s CMS payment program rules. Industry reaction has been mixed, more sober than initial fears in April, which means it’s a positive sign for CMS’ proposed rule to remain largely intact toward a final rule.

Where VBC meets interoperability

So CMS is pushing value-based care through a lot of its levers, and it’s a given that succeeding in VBC means better interoperability in all of its unpacking: standards, patient matching, population-level data transfer, push models, aggregation, vocabulary, data management agreements and governance and an end to legacy data blocking.

We’ve talked to and surveyed our customers, prospects and industry partners. In one survey, the No. 1 challenge to success in VBC was, of course, interoperability. The technology is largely here, and advancing through FHIR and apps, it’s the business practices that need to catch up.

About the author

Greg Fulton

Greg Fulton,
Industry & Public Policy Lead, Philips

Greg Fulton is Industry & Public Policy Lead for Philips PHM. He has extensive health IT experience in government relations at Congressional, Health & Human Services, state and industry organizational levels. He is a current member of the CommonWell Health Alliance Government Affairs Advisory Council and the HIMSS Government Relations Roundtable.

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