U.S. government finalizes meaningful use regulations

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With the goal of making its meaningful use (MU) IT stimulus initiative simpler and more flexible for providers, the U.S. government has issued final rules for its incentive and certification program for electronic health record (EHR) software.

Although many had hoped for a delay to the upcoming third and final stage of MU, the announcement by the U.S. Department of Health and Human Services' Office of the National Coordinator for Health Information Technology (ONC) and the U.S. Centers for Medicare and Medicaid Services (CMS) featured the final rule for stage 3 in addition to modifications to current stages of the MU program.

The reporting period for providers to attest to meaningful use of IT in 2015 has been dropped from 365 days to 90 days. New participants in the MU program can take advantage of a 90-day reporting period in 2016 and 2017. CMS has also changed reporting periods from the fiscal year to the calendar year.

In addition to decreasing the reporting burden for providers, CMS and ONC have made other changes they say support interoperability and improve patient outcomes. Providers can select the progress measures that are most meaningful to their practice, and have more time to implement changes to program requirements, according to CMS and ONC.

The number of MU objectives has been sharply reduced for 2015 through 2017. There are now 10 objectives for eligible professionals, including one public health reporting objective. Prior stages had included 18 total objectives. CMS has also decreased the number of objectives for eligible hospitals and critical access hospitals, dropping from 20 total objectives in prior stages to nine (including one public health reporting objective).

In addition, CMS and ONC encourage providers to apply for hardship exemptions if they need to switch or have other technology difficulties with their EHR vendor.

After evaluating the current programs, CMS said it restructured the objectives and measures of the EHR incentive programs to align with stage 3 and modified the measures in the stage 2 objectives that related to "patient action."

"These changes recognize the progress providers have made and realign with long-term goals," CMS said in a statement.

Stage 3

Looking ahead to the controversial third stage of MU, CMS said there will be eight objectives for eligible professionals, eligible hospitals, and critical access hospitals in 2017 and in subsequent years. More than 60% of the proposed measures in stage 3 require interoperability; 33% did so in stage 2.

CMS has also incorporated public health reporting with flexible options, continuous quality management reporting aligned with CMS quality reporting programs, and the use of application program interfaces (APIs) to support the development of "new functionalities to build bridges across systems and provide increased data access" to patients.

CMS noted that stage 3 requirements are optional in 2017, but all providers will be required to comply with stage 3 requirements beginning in 2018 using EHR technology that has been certified to the 2015 edition. Those that do proceed to stage 3 in 2017 will be able to use a 90-day reporting period. Stage 3 objectives and measures feature increased thresholds, advanced use of health information exchange functionality, and an overall focus on continuous quality improvement, according to CMS.

CMS has also announced a new 60-day comment period to gather feedback for stage 3 of the program, in particular as it relates to the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. CMS said it would use this feedback to inform future policy developments for the EHR incentives program and would also consider it during rulemaking to implement MACRA. That rule is expected to be released in the spring of 2016.

Meanwhile, the new final rule for the 2015 Edition Health IT Certification Criteria focuses on increasing interoperability and improving transparency and competition in the health IT marketplace, CMS and ONC said.


While the American Medical Association (AMA) is still in the process of reviewing final regulations, President Dr. Steven Stack said the group is pleased that CMS and ONC listened to AMA and the concerns of physicians over several key areas.

"In particular, the agency addressed the delay in issuing the modifications rule by allowing a hardship exemption for physicians who are unable to attest this year, providing needed relief for those uncertain about the 2015 program requirements," Stack said in a statement. "We also acknowledge that the agency is working to improve patient engagement by ensuring that patients can access portals while still providing flexibility in the measure requirements."

AMA continues to believe that stage 3 requires significant changes to ensure successful participation and to improve the usability and interoperability of EHR systems. Consequently, AMA is urging CMS to use the additional comment period provided for stage 3 to further improve the program and consider changes related to MACRA signed into law earlier this year, Stack said.

AMA also wants to make sure that EHR vendors have the time they need to further test products for interoperability, usability, safety, and security, he said.

More flexibility

Carla Smith, executive vice president of the Healthcare Information and Management Systems Society (HIMSS) North America, said the society appreciates the continued efforts of ONC and CMS to simplify and provide flexibility for meeting the meaningful use requirements. The society also supports the confirmation of the 90-day reporting period for 2015 and the emphasis placed on January 1, 2018, as the start of the period where providers are required to meet stage 3 objectives and measures.

While it is also still reviewing the regulations, the College of Healthcare Information Management Executives (CHIME) said it was pleased that CMS had finalized modifications to the current stages of the meaningful use program and agreed to extend the comment period on stage 3.

The rule provides flexibility for providers that are doing their best not only to meet the federal program's intent, but also to ensure the adoption of health IT that improves patient care, according to CHIME. While praising CMS for adopting the new 90-day reporting period for the current stages of the meaningful use program, CHIME also called for CMS to implement a hardship exemption for those unable to meet this time frame this year, given that there are fewer than 90 days left in 2015.

In addition, CHIME applauded CMS for modifying requirements surrounding patient access to electronic records. CHIME also noted that the extra comment period for stage 3 will enable providers, CMS, and other stakeholders to ensure that the next stage of meaningful use will advance interoperability and account for new payment models being advanced by Medicare.

With regards to ONC's final rule on EHR certification, CHIME said it supports key provisions that should lead to greater transparency regarding vendor products, improved testing and surveillance of health IT, and an improved focus on user-centered design.

A spokesperson for the American College of Radiology (ACR) said the college is still reviewing the new regulations and anticipates it will provide an overview of their impact on radiology within the next several days.

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