(Story updated at 10:30 p.m. ET)
The Obama administration, under pressure from Congress and the healthcare industry to ease its mandates for the use of electronic health records, issued regulations for the current and final stages of its incentive program for the technology. But officials also acknowledged the new rules are almost guaranteed to be revised in the coming months.
Changes are likely to be needed to accommodate federal legislation passed earlier this year and to slow the tempo of change that has repeatedly required federal officials to delay deadlines and add flexibility to the $31.5 billion program as EHR vendors and healthcare providers struggled to keep up.
The CMS and the Office of the National Coordinator for Health Information Technology issued the new testing and certification criteria for EHR vendors and the final regulations outlining the requirements for providers to meaningfully use the technology in a single 752-page document (PDF).
In a press statement accompanying the release of the rules, the CMS announced “a 60-day public comment period to gather additional feedback about the EHR incentive programs going forward, in particular with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)."
MACRA, which Congress passed earlier this year to replace the sustainable growth-rate formula, establishes a merit-based incentive payment system designed to prod physicians to move more of their patients into risk-based payment models. Achieving meaningful use will be a component of physicians' compensation under the MACRA pay scheme.
“We will use this feedback to inform future policy developments for the EHR incentive programs, as well as consider it during rulemaking to implement MACRA, which we expect to release in the spring of 2016,” the CMS said.
Dr. Patrick Conway, deputy administrator for innovation and quality at the CMS, said during a call with reporters that the rule offers flexibility to providers still trying to achieve Stage 2 goals this year. The new rule reduces the reporting period this year from one year to 90 consecutive days of meeting meaningful-use requirements. It also will provide some wiggle room for providers who had not yet upgraded to an eligible EHR system.
“Even if they were to deploy it tomorrow, they could report that performance in 2016 and avoid a penalty,” Conway said.
Conway asked for patience from critics calling on the administration to wait until 2017 to set the Stage 3 criteria. At this point, Conway said, the existing and future rules for the program could not be separated. “It's quite likely we would have penalized hundreds of thousands of providers” if those changes had been made.
The agency will collect comments for the next 60 days so officials can make changes to the Stage 3 rule next year, an approach Conway suggested would allow the CMS "to get to a similar place" as delaying the rule.
It's not clear how much patience the industry has. Physicians and hospitals weren't completely satisfied by the CMS' stated intent to modify the regulations to reflect their feedback.
American College of Cardiology President Dr. Kim Allan Williams, for example, said the rule “does not account for the reality of the situation faced by the medical community.” Williams pointed out that many providers have tried, failed and given up meeting the current requirements of the program. “That is why it is vital that CMS consider participation data from the current stage to see what is working and what isn't before outlining an upcoming stage.”
A recent Modern Healthcare analysis of program data indicated physician participation dropped by 12% in 2014 compared with a year earlier.
Most of the critics who argued for a delay in Stage 3 until 2017 similarly asked that Stage 2 achievements and failures be assessed first.
The American Medical Association, however, thanked the feds for granting a hardship exemption for providers who are unable to clear the bar this year. The AMA added that it hopes the additional comment period will yield further improvements.
The American Hospital Association called the rules “a mixed bag for hospitals and health systems and the patients they serve.” The AHA said it appreciated the 90-day reporting period this year, but the simultaneous release of the Stage 3 rules was “deeply disappointing” and “too much too soon.”
“Despite the urging of hospitals, physicians and Congress, the Stage 3 final rule includes many new and more challenging requirements,” the AHA said. “More than 60% of hospitals and about 90% of physicians have yet to attest to Stage 2.”
Sen. Lamar Alexander (R-Tenn.), who has taken up the cause of providers who want the government to put the brakes on the program, issued a statement Tuesday threatening legislation to alter it. Alexander, who chairs the Senate Health, Education, Labor and Pensions Committee, said the Obama administration “rushed ahead with a rule against the advice of some of the nation's leading medical institutions and physicians.”
Members of the College of Health Information Management Executives, however, is on the bus with where the CMS is heading with the meaningful-use regulations. The organization, which represents about 1,700 hospital CIOs, also said provisions of the ONC's new requirements for EHR vendors will “lead to greater transparency regarding vendor products; improved testing and surveillance of health IT, and an improved focus on user-centered design.”
Dr. Karen DeSalvo, head of the ONC, said those 2015 edition rules governing the functionality of EHRs will make data more available to consumers by requiring vendors to build in application programming interfaces, or APIs, into their systems, which she called “doorways to data.”
The regulations also improve cybersecurity and add tools intended to stop providers and vendors from engaging in practices the ONC has dubbed "information blocking."
The ONC also issued a final draft Tuesday of its road map for achieving interoperability of health information technology.