Despite public concern, the final rule is moving forward. Meanwhile, a recent survey says only 18% of healthcare execs understand the seismic implications.

Both the Information Blocking Rule and the Interoperability Rule (collectively referred to as the Proposed Rules) have been pushed to the final phase: a review by the OMB. This advancement of rules aimed to ease data sharing underscores HHS’s interest in improving interoperability without further delay, especially when it comes to the Information Blocking Rule. ONC’s proposed rule has undergone significant criticism by key industry players, but rather than being reviewed and revised, the rule was moved forward to the final stages. 

A recent survey by Deloitte indicates that a significant portion (43%) of health plans are well-prepared to meet or even exceed the parameters set forth in the final rule, according to the CTOs and CIOs surveyed. Healthcare executives in a separate survey, however, tell a different story: Only 18% of those surveyed in this study say they understand the implications of the Proposed Rules. Most (65%) report only being vaguely familiar with the set of data sharing rules. This is a problem because the Proposed Rules are sure to have seismic implications on the industry. 

As the rules move to their final phase, we will evaluate the concerns raised by the public comment period and the continued efforts of large healthcare stakeholders for clarification on the proposed Information Blocking Rule. We will also look at the logistics of implementing these rules, asking how our industry may – or may not be – well-prepared to tackle interoperability once and for all. 

ONC’s Information Blocking Rule Raises “Significant” Concerns

Let’s start with what we can all agree on: the goal of seamless data sharing is a noble one. Nearly all stakeholders understand that patients need better access to their data. In this increasingly digital age, rules must evolve accordingly to further define a patient’s right to access their medical data. But for some major healthcare industry experts and organizations, the progression of the Proposed Rules to final review is where the rubber meets the road. In particular, many feel ONC’s nearly final Information Blocking Rule doesn’t do enough to define important data sharing elements (specifically, electronic health records lack a standard definition). 

In addition, strong concerns have been raised surrounding data privacy over open API connections. Patient medical data is incredibly valuable, say experts, and many agree that patients should have the ability to control when and where their data is used. Experts worry that if patient data is commodified (for example, by third parties), it could result in unintended consequences for the patient. To these experts, a lack of insight into when and where patient data may be used (and who controls those rights) is a major oversight of the Proposed Final Rules. Read more about how API connections improve data sharing here.

“AMA is calling for controls to be instituted that establish transparency as to how health information is being used, who is using it, and how to prevent the profiteering of patients’ data.”

(source)
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What's on the table: Two Rules, Same Goals

Both ONC and CMS issued proposed rules that aim to tackle the complex problem of data sharing. Though used interchangeably and collectively at times, these are two separate rules. Here’s a look at each one.

Proposed Information Blocking Rule

  • Released by: ONC in February 2019
  • Status: Under OMB Review. Anticipated final release this year.
  • Has been criticized for being overly broad and administratively complex

Proposed Interoperability Rule

  • Released by: CMS in February 2019
  • Status: Under OMB Review as a “long-term action item” scheduled to be finalized no later than March 2022

These rules are collectively termed “the Proposed Rules” and were issued by offices under HHS as part of a broader goal to improve patient access to health data

The proposed implementation times – some as soon as January 1, 2020 – have also been called out by critics. Rapid adoption is a risk, particularly when awareness and understanding of the rules is relatively low. Groups have called on ONC and CMS to delay implementation and stagger rule deadlines. If this does not occur, the Proposed Rules as currently written will result in overlapping deadlines, which “creates layers of complex requirements for both providers and vendors,” says Mari Svaickis, Vice President of Federal Affairs for the College of Healthcare Information Management Executives (CHIME).  Additionally, the Information Blocking Rule will require EHR and health IT vendors to overhaul products, creating a “substantial industry shift,” according to Svaickis. It is unclear whether or not OMB will address implementation times in their final review. 

The Health IT Advisory Committee (HITAC) has called on ONC to address specific concerns surrounding the proposed Information Blocking Rule. HITAC, a product of the 21st Century Cures Act, regularly recommends policies to ONC. In addition to data privacy and implementation concerns, the group made other recommendations to ONC in order to ease the burden of the proposed Information Blocking Rule on providers and vendors. Their recommendations are threefold:

  1. Create a new version of the health IT certification (versus updating the 2015 certification)
  2. Better define some of the terms of the rule itself
  3. Ease the penalty for stakeholders found to be in violation of the rule, currently written as $1 million per instance of information blocking

Supporters Say Benefits Outweigh Risk

The goal of providing patients greater access to data aligns perfectly with some organizations, particularly those who feel health plans are able to shoulder the interoperability burden. Health plans have made progress towards addressing interoperability already, with increasing focus on API integration (only 3% of health plans surveyed don’t use API). 

AMGA President and CEO Jerry Penso, M.D. wrote, “Access to claims data from all payers has been a longstanding priority for AMGA and its members. CMS’ latest initiatives support AMGA’s work by allowing providers to access Medicare claims data. If successful, CMS’ initiatives should inspire commercial insurers to follow suit in data sharing, a crucial step in delivering the most effective care for patients and improving health outcomes.” Though he was specifically referring to another data-sharing initiative, CMS’ “Data at the Point of Care (DPC)” pilot, the implication is that AMGA supports all of CMS’ interoperability rules. 

Where to from here?

The concerns are on the table, and the rules appear to be moving forward anyway. Detractors are likely still on guard from the rollout of previous rules, namely what was previously called “Meaningful Use” of electronic health records, which fell short of delivering on its promises. Just over 40% of health plans say they are already addressing interoperability as positioned in the Proposed Rules. But that still leaves 60% of health plans in limbo. 

ClarisHealth has been tracking the Proposed Rules closely over the course of this year. For more on the topic, please see the following articles:

As a provider of comprehensive technology, ClarisHealth is well-versed in supporting strategic interoperability initiatives at health plans of all sizes. We work with vendors, providers and health plans to make total interoperability possible by utilizing our technology solution, Pareo. Health plans aren’t meant to work in silos. Find a partner that can help. Reach out to ClarisHealth today to begin a conversation about how best to prepare your plan and its vendors for adhering to the proposed rules.

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