Industry voices concerns about proposed HHS interoperability rules

Making electronic health information accessible to patients and providers is the goal of two proposed Department of Health and Human Services rules. However, stakeholders question whether the aims are achievable as currently written.

In accordance with provisions of the 21st Century Cures Act, the Centers for Medicare and Medicaid Services and the Office of the National Coordinator for Health IT have released separate—but related—proposed rules pressing the healthcare industry to improve interoperability.

CMS is proposing requirements that Medicaid, the Children’s Health Insurance Program, Medicare Advantage plans and Qualified Health Plans in the Federally-facilitated Exchanges must provide enrollees with immediate electronic access to medical claims and other health information electronically by 2020.

While America’s Health Insurance Plans says it is committed to providing patients with meaningful access to their health information, AHIP has concerns about the timeline for implementing the CMS proposed rule.

“Based on preliminary discussions with our member plans, we have significant concerns that the implementation timeline outlined in the Administration’s proposed rules is unrealistic,” wrote AHIP in a statement submitted to the Senate health committee on Tuesday. “The proposed effective dates—between January 1, 2020, and July 1, 2020 (depending on plan type)—are simply not feasible; they would pose significant compliance burdens not only on health insurance providers, but also healthcare providers and others in the healthcare system.”

AHIP also told lawmakers that additional time is needed to ensure that entities can comply with standards that are still being developed.

“The timeline also should take into account the fact that once those standards are finalized, health insurance providers will have to build and test the new standardized technology as well as ensure that the third-party entities are able to securely connect to their systems,” AHIP’s letter states. “Furthermore, there are additional operational parameters that need to be finalized for successful implementation, such as the Trusted Exchange Framework and Common Agreement rules.”

In addition, the CMS proposed rule requires—as part of the Medicare Conditions of Participation—that hospitals send electronic event notifications to another healthcare facility or to another community provider when a patient is admitted, discharged or transferred.

The American Hospital Association has stated that it does not support including electronic event notification as a condition of participation for Medicare and Medicaid.

While Christopher Rehm, chief medical informatics officer at LifePoint Health, testified on Tuesday before the Senate health committee that he “directionally” supports the concept, he told lawmakers that the CMS proposed rule puts the cart before the horse.

“It sounds like it would be simple to implement, but there are numerous unanswered questions and operational considerations,” said Rehm in his testimony. “For example, not all EHRs can generate these messages—and this functionality is not required of vendors under the ONC certification rules. And if a provider is not connected to a health information exchange or similar network, of which the most advanced ones are quite costly, it is an enormous undertaking—in both time and money—to connect to these other providers and facilities individually.”

Rehm contends that for providers to comply with such Medicare Conditions of Participation (CoP) they must clearly understand what it is they must do and how they will be surveyed and judged to determine compliance.

“This proposal lacks both of those elements, which is concerning given the tremendous penalties hospitals face for failing to comply with CoPs, including termination from the Medicare program,” added Rehm. “Instead, I encourage the Administration to focus on its current activities to improve interoperability, such as continuing to advance the goals of the Trusted Exchange Framework and Common Agreement, as well as its proposals in this rule to further ensure vendors are accountable for the products they develop.”

ONC has made public its long-awaited proposed rule implementing the information blocking provisions of the 21st Century Cures Act, which includes seven exceptions to the definition of information blocking—the act of intentionally interfering with the sharing of electronic health information.

Also See: ONC proposed rule aims to provide clarity on information blocking

“I want to ensure these rules will make the problem of information blocking better, not worse,” said Sen. Lamar Alexander (R-Tenn.), chairman of the Senate health committee, during a hearing held on Tuesday to examine the proposed rules, which he described as complicated.

“Is the door still open for bad actors to game the system and continue to information block?” Alexander asked in his opening statement.

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But, according to HHS, if the CMS and ONC proposed rules are implemented they will give more than 125 million patients easier access to their medical records in an electronic format.

However, the Health Innovation Alliance (formerly Health IT Now), a coalition of patient groups, provider organizations, employers and payers, is worried that the proposed rules from HHS could increase provider burden and stop short of achieving widespread interoperability.

“While we are pleased that, at long last, progress has been made toward fulfilling the promise of 21st Century Cures and holding information blockers to account, we believe the proposed rules are in need of further reform,” said Joel White, executive director of the Health Innovation Alliance.

“Specifically, we are concerned that the proposed rules could increase provider burdens, including keeping doctors on the hook for vendors’ technology costs,” added White. “ONC should adopt standards that promote interoperability, including standards that are normalized, eliminate custom tweaking, and that make interfacing simple and inexpensive. We will work to ensure the final rules are the best approach to achieving widespread interoperability in a timely fashion.”

Lucia Savage, a former ONC chief privacy officer, testified during Tuesday’s Senate committee hearing that the agency is proposing “bold reforms” that could significantly impact interoperability—particularly in the area of information blocking.

However, she observed that while the 21st Century Cures Act applies the prohibition against information blocking to developers of “health information technology” as defined in HITECH Section 13101(5), ONC’s proposal applies only to certified electronic health records developers—a subset of this category.

“This limitation leaves out many types of health information technology where individuals' health facts are collected,” said Savage in her testimony. “For example, the proposed rule does not reach to health information technology in the emerging world of connected devices or Software as a Medical Device, and seems to omit any non-certified EHR, such as a lab or pharmacy electronic records system that is not certified.”

Nonetheless, at the hearing, Alexander wondered whether the two proposed HHS rules—CMS and ONC—are moving too fast and whether the standards for data elements are too rigid.

“In 2015, I urged the Obama Administration to slow down the Meaningful Use program, which they did not do, and looking back, the results would have been better if they had,” Alexander added. “Maybe the train was going too fast to slow down. But I want to make sure that these new rules are implemented at a pace that gets us where we want to go, but doesn’t do it so rapidly that it makes it more difficult.”

Ben Moscovitch, project director of health IT at The Pew Charitable Trusts, testified before the Senate committee that the use of standards for application programming interfaces (APIs)—which enable different systems to communicate—requires consistency both for how information can be accessed and how the data elements are represented.

“To accomplish this, ONC identified the use of a standard called FHIR (Fast Healthcare Interoperability Resources) for data exchange and provided guidance on how to consistently implement it for better interoperability,” said Moscovitch. “As ONC finalizes the rule, Congress should ensure that the agency maintains its commitment to these standard APIs.”

Mary Grealy, president of the Healthcare Leadership Council, said in her testimony that the organization is calling for common standards serving as “rules of the road” to improve patient matching as well as the rapid adoption and implementation of open standards-based APIs such as FHIR.

“We applaud the efforts of ONC and CMS to eliminate information blocking and ensure that consumers have easy access and the ability to share their health information as they wish,” testified Grealy. “Given the significant impact of these proposed rules, including strong enforcement and penalties, we are requesting that ONC and CMS grant, at a minimum, a 30-day extension of the deadline for submitting comments on the proposed rules.”

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