During a Senate Health, Education, Labor and Pensions committee hearing Tuesday, Senate leaders pressed officials with the U.S. Department of Health and Human Services (HHS) on the progress being made to implement the health IT provisions in the 21st Century Cures Act, which was signed into law December 2016.
The law, considered to be landmark healthcare legislation, largely focuses on medical research and changing the approval process for new drugs and medical devices but also includes a number of health IT provisions aimed at improving interoperability and electronic health information exchange, as well as reducing the burden on providers using electronic health records (EHRs).
Leaders from three agencies within HHS—the Office of the National Coordinator for Health IT (ONC), the Centers for Medicare & Medicaid Services (CMS) and the Office of the Inspector General (OIG), all of which are involved with implementing health IT provisions in the Cures Act—testified during the hearing.
Senator Lamar Alexander (R-Tenn.), chairman of the Senate HELP committee, said during the hearing, “The goal of the health IT provisions in Cures was to make it easier for patients to access their health records and for doctors and hospitals to get the information they need to treat patients. The law set clear deadlines for the administration to meet.”
However, Senator Patty Murray (D-Wash.), ranking member of the committee, expressed concerns that the legislation’s health IT provisions are not being implemented as intended by Congress. “I am concerned, for one, that [President] Trump has asked Congress to slash ONC’s operating budget, that will not help our efforts today,” Murray said, referring to President Trump’s fiscal year 2018 budget request for ONC for $38 million, down from $60 million in 2017.
Murray continued, “And Trump didn’t include anything in his budget for information blocking, requested by ONC and Office of the Inspector General which helps certify and protect health information. We need to make sure the agencies involved have access to the funding they need.”
Jon White, M.D., ONC’s deputy national coordinator for health information technology, testified, “Under the current budget proposal, we’re expecting to meet all the requirements of the Cures Act, with the exception of the EHR reporting program. As you know, there was $15 million that was authorized in the Cures Act but not appropriated,” White testified. He was referring to the provision of the Cures Act that authorizes $15 million for ONC’s certification process to improve interoperability and fight information blocking by establishing a grant program to create an unbiased reporting system to engage stakeholders and gather information about EHR usability, interoperability, and security.
Information Blocking Enforcement
21st Century Cures establishes authority for the HHS OIG to investigate claims of information blocking and assign penalties for practices found to be interfering with the lawful sharing of EHRs. Organizations that are found to have committed information blocking face civil monetary penalties up to $1 million.
James A. Cannatti III, HHS OIG’s senior counselor for health information technology, testified that information blocking is a practice that inappropriately impedes the flow or use of information.
“OIG historically had no authority that allowed us to investigate or take enforcement action based solely on acts of information blocking, rather, we look to leverage existing authority to hold wrong doers accountable. With the passage of Cures, Congress empowered OIG to directly address information blocking problems,” Cannatti said,
The Cures Act directs the HHS Secretary to first identify “necessary and reasonable activities” that do not constitute information blocking. “ONC has been tasked with that rule making. ONC’s final rule will provide the legal basis that OIG will use to assess conduct during investigations and enforcement activities,” Cannatti said, adding, "We are engaged in preparing, so when the rule making is complete, we’re ready to enforce.”
He continued, “In the meantime, OIG has been preparing for effective, efficient and fair enforcement. Our goal is to protect patients and the health system to stop information blocking. We aim to leverage our new authorities to change behaviors in the industry. We believe this can be accomplished with clear rules of the road and targeted enforcement against those who choose to break it.”
Cannatti also noted that the Cures Act information blocking provision covers a broad range of conduct and arrangements. “It covers from large health IT providers and developers to individual physicians, and the information blocking landscape is complex; it combines highly technical issues with a breadth of business arrangements.” He also said that stakeholder engagement is critical to gaining a deep understanding of the complex landscape. “We have held a dozen stakeholder meetings with representatives from a wide cross section of healthcare and tech communities, and the insights gained will help us as we begin enforcement.”
When pressed by Senate committee members as to the timeline on ONC rule making on information blocking, ONC’s White was evasive about providing a timeline. “My counsel told me not to report on rulemaking in progress,” he said. White also made the case that information blocking is a “complex issue,” and noted, “it’s important to distinguish inappropriate actions from appropriate actions.”
Trusted Exchange Framework
To support the secure exchange of electronic health information, the 21st Century Cures Act tasks ONC with developing and supporting a voluntary trusted exchange framework and common agreement. White reported that ONC has held two initial public meetings as well as one round of public comments and plans to have a draft document of the trusted exchange framework and common agreement for public review by the end of the year.
Senator Tammy Baldwin (D-Wis.) pointed out the progress being made by organizations such as CareQuality to establish network-to-network exchange frameworks and expressed concerns about “reinventing the wheel.” Questioning White on these efforts, Baldwin said, “The Cures Act requires ONC to develop or support a voluntary framework and agreement for exchange of information across networks, taking into account and leveraging the work of existing frameworks. We should not create an entirely new framework. How do you plan to support the advancement of a trusted framework, utilizing industry work in this space and not duplicate existing agreements?”
White responded, “Progress has clearly been made by networks and their trusted frameworks. That’s why we have been focused on the areas of variation that exist between these networks and frameworks that can limit the ability of those organizations to connect with each other and support nationwide interoperability. We want to build on that great work.”
As an example of the variations that exist, White noted that networks have different policies to what level users must be identify proofed and authenticated in order to be able to access. “These are areas ONC believes we can provide minimal requirements that enable and build trust between organizations, and we think we can be a neutral coordinator of the industry efforts to make sure no particular group is disenfranchised.”
Under the Cures Act, ONC also is tasked with developing new conditions for certification of HIT related to: access, use, and exchange of electronic information; usability, security, and business practices; real-world testing; as well as publishing application programming interfaces. On that topic, White was again evasive as to the progress being made, saying that it involves rulemaking, "so I’m not at liberty to say kind of where we are on that—but, we have been busily addressing those," he testified.
CMS and Reducing Administrative Burdens
The Cures Act specifies that the HHS Secretary must establish a goal, strategy and recommendations to reduce the regulatory or administrative burdens related to the use of electronic health records no later than one year after the date of enactment.
Kate Goodrich, M.D., chief medical officer at CMS and director of the center for clinical standards and quality, said that the reduction of burden on providers is a top priority for CMS, noting the agency’s launch last week of its Patients over Paperwork initiative. “This is a comprehensive and holistic look across CMS, as it relates to Meaningful Use and quality measure reporting. We are also spending a huge amount of time listening to clinicians and to patients.”
Goodrich, who continues to practice medicine as a hospitalist, testified that she has an “on the ground” perspective and sees the “promises and pitfalls of health IT and EHRs.” “There are still too many burdens on clinicians, and we are a long way from true interoperability. Far too often, I still have to call, fax, copy or manually enter information into a health record.”
As directed by the Cures Act, CMS has adopted and proposed for clinicians a specific hardship exception for hospitals and clinicians whose EHR technology becomes decertified. In accordance with the Cures Act, CMS also is publicly posting data online that shows the percentage of hospitals and eligible professionals that have demonstrated Meaningful Use of certified technology in the Medicare and Medicaid EHR Incentive Programs.
Goodrich also testified, “CMS anticipates referring any cases of information blocking to OIG for investigation. CMS now requires clinicians to attest that they have not knowingly or willingly limited or restricted the compatibility or interoperability of their certified EHR technology as part of the Quality Payment Program.”
White also noted that ONC is working with CMS to reduce the administrative and regulatory burdens for physicians. “We found four areas of focus or high priority areas to address—federal reporting requirements for quality; federal documentation requirements including billing; issues with technology, including usability of software and other requirements, and public health and state level requirements and third-party requirements. We are meeting on a regular basis, including with physicians and hospital groups,” White said.
However, Sen. Alexander pressed HHS leaders to come up with a more specific goal for how they were going to reduce the regulatory burdens for physicians. He specifically referenced an American Medical Association study that found doctors spend 49 percent of their time on EHR and desk work. “I think you should involve the physicians in a collaborative process to say what can we do to reduce it. Ask them, what do you think it should be? Let’s agree on a number, like get it down to 40 percent, and let’s identify the things we can do to do that.”