The 21st Century Cures Act, signed into law in December 2016, is meant to reduce the burdens of providers using electronic health records and to advance healthcare information technology interoperability. However, some members of the Senate are concerned that the legislation’s HIT provisions are not being implemented as intended by Congress.
“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,” said Sen. Lamar Alexander (R-Tenn.), chairman of the Senate health committee, during a hearing Tuesday on the legislation. “The law set clear deadlines for the administration to meet.”
Jon White, MD, deputy national coordinator for health IT, noted in his testimony before the committee that ONC plays the primary role in implementing the HIT provisions in the Cures Act.
“We agree with Congress that health IT must be more interoperable, that it should be easier to use for everyone, and that information must flow seamlessly and without unreasonable blocking,” testified White. “While the nation’s made significant progress in digitizing health information, important work remains particularly around interoperability, clinician burden and information blocking.”
But, Senator Patty Murray (D-Wash.), ranking member of the committee, expressed her concern that the Trump administration has asked Congress to slash ONC’s operating budget and that the President “did not include anything in his proposed budget for information blocking—requested by ONC and the Office of the Inspector General—which helps certify and protect health information.”
The Cures Act lays out a definition for information blocking, provided the mechanisms for reporting and investigation of information blocking actions, and established penalties for entities and individuals found to be in violation. Murray contends that it’s critical the “agencies involved have access to the funding they need in order to make this a success,” but the President’s fiscal year 2018 budget request for ONC was $38 million—down from $60 million in Fiscal Year 2017.
Nonetheless, White reassured the committee that under the current budget proposal ONC expects to meet all of the requirements of the Cures Act with the exception of one provision. “Due to competing priorities,” the agency is unable to move forward with implementation of Section 4002(c) of the legislation, which calls for a transparent process to develop criteria as part of an “EHR Reporting Program” for certified health IT, he noted.
The reporting program was envisioned as a way to engage stakeholders and gather information about EHR usability, interoperability and security to help providers better choose EHR products.
Under the Cures Act, Murray also pointed out that ONC is tasked with supporting a framework for “trusted exchange” of electronic health information across networks and developing new conditions for certification of HIT. Regarding the latter, the law codifies new authority for ONC to address interoperability through additional conditions of certification for HIT developers related to: access, use, and exchange of electronic information; usability, security, and business practices; real-world testing; as well as publishing application programming interfaces.
“Both of those policies are due within the next year,” she reminded the agency.
According to White, ONC has begun to implement the trusted exchange frameworks and common agreement provisions outlined in the Cures Act. The Trusted Exchange Framework and Common Agreement (TEFCA) “will be a critical component of nationwide network-to-network exchange of health data and our charge to support nationwide interoperability,” he added.
White noted that the agency has held two of three initial public meetings on the TEFCA and had one round of public comments, with the goal of releasing a draft document for public comment by the end of 2017.
As far as conditions for HIT certification, White contended 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.” Pressed by Alexander, he added that ONC has “started staff discussions about potential rules.”
When it comes to implementing the information blocking provisions in the Cures Act, White was similarly evasive about ONC’s planned rulemaking.
“Dr. White, in addition to Sen. Murray and me, the Congressional Research Service has never heard of a prohibition in the Administrative Procedure Act that would keep you from telling us when you’re going to have a rule that defines what is information blocking and what it isn’t,” said Alexander. “So, after you consult with your counsel, we would appreciate your letting us know when that rule is coming out.”
In response, White quipped: “I’ll have my counsel talk to your counsel.” Not amused, Alexander told him, “No, just give us the answer.”
Nonetheless, White made the case that it’s a “complex issue with significant implications for patients and the industry,” while at the same time emphasizing that “it’s important to distinguish inappropriate practices for information blocking from appropriate ones like protecting patient privacy and security.”
He reiterated that ONC will “use the tools provided by Congress through the Cures Act to tackle today’s challenges of interoperability, usability, and information blocking.” Also, in accordance with Cures, he pointed out that ONC’s two health IT federal advisory committees have been shut down and that the agency will launch a new HIT Advisory Committee—as called for in the legislation—and will hold the first meeting this winter.
CMS and reducing regulatory burdens
Section 4001 of the Cures Act specified that the Secretary of Health and Human Services 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. In particular, Alexander indicated that he wants to see HHS reduce the EHR documentation burdens on physicians.
Kate Goodrich, MD, chief medical officer at the Center for Medicare and Medicaid Services, said CMS is working closely with ONC and the Department of Health and Human Services’ Office of Inspector General to implement the HIT provisions of the Cures Act. Specifically, she said CMS is supporting ONC’s efforts to establish a goal for the reduction of regulatory or administrative burdens relating to the use of electronic health records, as required by the law.
“There are still too many burdens on clinicians, and we are a long way from true interoperability,” testified Goodrich, who is also director of the CMS Center for Clinical Standards and Quality.
As directed by the Cures Act, she added that CMS this year has adopted and proposed for clinicians a specific hardship exception for hospitals and clinicians whose EHR technology becomes decertified to “recognize the difficulty healthcare providers face when the software they have invested in becomes decertified.”
Also, in accordance with the Cures Act, Goodrich told lawmakers that the agency is now publicly posting data online that shows the percentage of hospitals and eligible professionals—delineated by state—who have demonstrated meaningful use of certified EHR technology in the Medicare and Medicaid EHR Incentive Programs.
For its part, CMS “anticipates referring any cases of information blocking it becomes aware of to the OIG for further investigation” as required by the Cures Act,” according to Goodrich. In addition, she reported that the agency “now requires clinicians to attest that they have not knowingly and willfully limited or restricted the compatibility or interoperability of their certified EHR technology as part of the Quality Payment Program.”
However, the American Hospital Association has raised its concerns about CMS asking hospitals to attest to three separate statements, namely that they: did not “knowingly and willfully take action to limit or restrict the compatibility or interoperability” of their certified EHR; have implemented the technology to support “secure and trusted bidirectional exchange” of health information; and have “responded in good faith and in a timely manner” to requests for exchange information from others.
According to AHA, the last two of the three attestations statements “go beyond both statutory intent and the current capability of the technology hospitals have available to them” which “unfairly places hospitals at risk of payment penalties for technical issues outside of their control.” As a result, the association is urging CMS to remove the second two attestations but keeping the statutory requirement that hospitals did not knowingly or willfully take action to limit or restrict the compatibility or interoperability of their EHRs.
OIG and information blocking
When it comes to electronic health information blocking, Section 4004 of the Cures Act establishes authority for the HHS OIG to investigate claims of data blocking and assign penalties for practices found to be interfering with the lawful sharing of EHRs. In that regard, the law supports interoperability through several provisions including the prohibition of information blocking and authorization of penalties of as much as $1 million per violation.
James Cannatti, OIG’s senior counselor for health IT, discussed in his testimony before the committee the office’s new information blocking investigative and enforcement authorities provided under the Cures Act, which covers a broad spectrum of conduct and arrangements including EHR health vendors and providers.
“Although an area of concern for some time, OIG historically had no authority that allowed us to investigate or take enforcement action based solely on acts of information blocking,” Cannatti testified. “With the passage of the Cures Act in December of 2016, Congress empowered OIG to directly address the problem of information blocking.”
According to Cannatti, OIG is working to formalize processes for sharing complaints, referrals and other information within HHS. For its part, he said ONC has been tasked with rulemaking which will address the definition of information blocking within the meaning of Section 3022 of the Cures Act which will provide the legal basis that OIG will use to assess conduct during its investigations and enforcement activities. However, Cannatti added that they “are not anticipating imposing penalties under the new authorities until after that (ONC) rulemaking.”
“We aim to leverage our new authorities to change behaviors in the industry,” he concluded. “We believe this can best be accomplished through a combination of clear rules of the road for those who want to comply with the law and targeted enforcement against those who choose to break it.”
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