HIT Policy Winds Get Stronger as CMS, ONC Regulations Set to Drop Any Day

Nov. 1, 2018
The calendar has now turned to November as health IT stakeholders continue to anxiously await regulations from federal health agencies, some of which are sure to come in the next 60 days.

The calendar has now turned to November as health IT stakeholders continue to anxiously await regulations from federal health agencies—some of which are sure to come in the next 60 days—that will have a significant impact on the future of healthcare policy and payment.

As Healthcare Informatics has learned from senior policy officials at CHIME (the Michigan-based College of Healthcare Information Management Executives), a plethora of federal regulations are coming down the pike, with a strong likelihood that the first of these rules will be dropping this week. “We are in wait-and-see mode right now, but we know that so much [regulation] is about to be coming from the administration, and that will keep us and our members very busy,” says Leslie Krigstein, vice president, congressional affairs at CHIME, an executive organization that serves chief information officers (CIOs), chief medical information officers (CMIOs), chief nursing information officers (CNIOs) and other senior healthcare IT leaders.

At the CHIME Fall CIO Forum in San Diego this week, speaking exclusively to Healthcare Informatics, Krigstein and Mari Savickis, vice president, federal affairs at CHIME, outlined what they believe could be in store for providers, just in the next 60 days alone:

  • Final changes to the Physician Fee Schedule and Quality Payment Program (QPP) 2019 rule that was proposed in July. This rule is expected by the end of the week, according to CHIME’s policy leaders, though of course nothing is set in stone.
  • A second draft version of TEFCA (the Trusted Exchange Framework and Common Agreement), a federally-constructed interoperability initiative that was announced in January of this year. Savickis notes that National Coordinator for Health IT Donald Rucker, M.D., recently said at CHIME’s Advocacy Summit a few weeks ago that the plan was to release the next iteration of TEFCA before 2019.
  • The long-anticipated information blocking rule from the Office of the National Coordinator for Health IT (ONC), as mandated under the 21st Century Cures Act. ONC has delayed regulation around information blocking a few times already, and for the last year, health IT groups and senators have been pushing for the rule’s release. It would be a major surprise if this proposed rule wasn’t released before the end of the year.
  • Another rule on interoperability and patient access, which Savickis believes could include new information on the possibility of revising Medicare Conditions of Participation, with the idea being that clinicians who do not engage in certain data sharing activities would be forced out of Medicare.
  • Finally, Krigstein notes that the Senate, upon returning from recess for the midterm elections, could take a long look at aligning 42 CFR Part 2—which keeps mental health records separate from other health records and prevents the sharing of these confidential treatment records without a patient's explicit consent—with HIPAA [the Health Insurance Portability and Accountability Act], as CHIME and many other industry stakeholders have been urging for. This alignment provision was not included in the recent passing of The Opioid Crisis Response Act of 2018, but some believe that it will be reconsidered.

Indeed, there is certainly a ton to unpack from all of these upcoming regulations, and when it comes to interoperability, and how much participation the government might mandate, many of these components—TEFCA, the “Promoting Interoperability” rule that was just recently finalized, the information blocking rule, and the possibility of revising Conditions of Participation—are all intertwined.

CHIME, for one, has taken the stance that revising the current Medicare Conditions of Participation to revive interoperability would not be a smart idea. Although the Centers for Medicare & Medicaid Services’ (CMS) has only yet issued an RFI (request for information) on this possibility, Savickis says that by itself has put the industry on notice. “It was a shot across the bow,” she says. “CMS Administrator [Seema Verma] has been vociferous with her statements that she will pull every policy lever at her disposal. So when she put the RFI out, that meant she was serious.”

Savickis says that right now it’s mostly speculation until a proposed rule comes out, if it does at all. “And I don’t think it will be quite as hard-hitting as it potentially could have been, but rather there will be some sort of middle ground,” she says. To that end, Savickis notes that CHIME’s position is that “We don’t feel like you can drive interoperability by taking away Medicare reimbursement. It also doesn’t get at the root cause issues such as standards and identifying patients accurately. These are the secret sauces to interoperability—not taking away someone’s Medicare reimbursement. It’s too much of a ‘sledgehammer-to-kill-an-ant’ approach,” she says.

The information blocking rule, meanwhile, which according to the Cures Act carries a $1 million fine for those who violate it, “is going to be a hefty one that is making our members concerned and foundation partners nervous,” says Krigstein. While many stakeholders believe that true interoperability will not be achieved if vendors and providers act to impede the flow of health data for proprietary reasons, there is a high degree of uncertainty as to what exactly constitutes information blocking.

“That grey area is a big concern for our members,” Krigstein admits. “What may be information blocking in the eye of a provider patient, or vendor, may not be to [someone else]. So how specific will this rule be? It could be very tricky if you get very specific, but if you leave more room open for interpretation, you have also the ramifications of that,” she says.

Savickis adds that this rule might also include a mandate that HL7’s Fast Healthcare Interoperability Resources (FHIR) standard be adopted as part of health IT certification requirements.

Meanwhile, regarding the alignment of 42 CFR Part 2 with HIPAA, CHIME has been a strong supporter of changing patient privacy laws so that providers could more easily share information about a patient’s history of substance use. CHIME has not been alone in its support for alignment, but to the chagrin of many health IT stakeholders, the provision was dropped from September’s opioids package.

Krigstein says there is a commitment in Congress to “at least give this a strong look,” while Savickis points out that initiatives such as TEFCA conflict with keeping the 42 CFR Part 2 law intact. “How can we have an interoperable ecosystem and how do you drive care coordination if you don’t have this large chunk of patient data [accessible]?” she asks.

On the positive front, Krigstein and Savickis note that CHIME and its members are quite happy that the administration has made it a priority to align requirements for physician practices and hospitals. For example, they say, it’s expected that the requirements and timeframes for the upcoming Physician Fee Schedule and Quality Payment Program final rule for clinicians will align with the recently finalized Promoting Interoperability rule for hospitals.

In the end, much of the regulation pre-release discussion is merely speculation, but at this week’s CIO Forum, and elsewhere, it’s a certainty that industry watchers are waiting—perhaps nervously—for the many rules and regulations that will affect health IT stakeholders for years to come.

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