On Monday, March 23, the U.S. Department of Health and Human Services (HHS) and the Centers for Medicare and Medicaid Services (CMS) issued a notice of proposed rulemaking for Stage 3 Meaningful Use of Electronic Health Records (EHRs). On the same day, HHS’s Office of the National Coordinator (ONC) for Health Information Technology issued a proposed rule and a new timeline for its Voluntary 2015 Edition EHR Certification Criteria (2015 Edition). According to ONC, the 2015 Edition is the first in a series of incremental rules, to be published every 12-18 months, which will allow the certification regulations to respond to stakeholder feedback, support delivery reform and clinical transformation programs, and chart a course toward enhanced interoperability, information exchange, quality improvement, patient engagement and patient safety. Given this delivery of rules in smaller, incremental requirements, it is hoped that these will be more easily integrated into software development cycles.

Meaningful Use

The Stage 3 Meaningful Use proposed regulations continue to press physicians and hospitals to meet rigorous qualifications, and will require all eligible Medicare and Medicaid providers and hospitals to attest to meaningful use stage 3 by 2018. In addition, while there has been some flexibility in recent reporting periods, the proposed rules make it clear that the reporting period for 2017 will be a full year, regardless of the stage (1, 2 or 3) that is being attested.

The focus of the Stage 3 Meaningful Use is on the advanced use of EHR technology to promote improved patient outcomes while requiring increased interoperable exchange of health information among providers. Specifically, the proposed rules seek to ensure that patients have easy access to their health information, that providers are in fact coordinating care for patients, and that data is collected in a format that can be shared across multiple healthcare organizations. The proposed regulations focus on eight objectives: protecting patient health information, electronic prescribing, fostering clinical decision support, computerized provider order entry, patient electronic access to health information, coordination of care through patient engagement, health information exchange, and public health and clinical data registry reporting.

Some of the specific Stage 3 rules require the following:

• More than 25 percent of patients seen by a provider or discharged from a hospital or emergency department must have “actively engaged” with their electronic records. This is up from Stage 2’s 5 percent rule of viewing, downloading or transmitting data from their records.
• With respect to patients seen by a provider or discharged from a hospital or emergency department, more than 35 percent will have had a secure message sent to them or will have had a response to a secure message sent by the patient.
• Providers and hospitals will have used their EHR to create a summary of care that is electronically exchanged with other providers for more than 50 percent of transitions of care and referrals.
• In more than 40 percent of transitions of care, a provider will have incorporated in its EHR, a summary of care from an EHR used by a different provider.
• For providers and hospitals, more than 80 percent of medication orders must have used computerized provider order entry (CPOE), and more than 60 percent of laboratory orders and 60 percent of diagnostic imaging orders will have been recorded by CPOE. These are increases from Stage 2’s required 60 percent of medication orders and 30 percent of laboratory orders and imaging orders.
• The CPOE “radiology” category is expanded to include “diagnostic imaging” and for Stage 3, attestation will include ultrasound, MRI and CT scans.
• For providers, more than 80 percent of prescriptions must be queried for a drug formulary and transmitted electronically. For hospitals, more than 25 percent of hospital discharge medication orders must be queried for a drug formulary and transmitted electronically.

While Medicare and Medicaid incentive payments have been the core of the program since the program began in 2011, the requirement for all providers to attest to Stage 3 by the beginning of 2018 is designed to further push providers to improve healthcare delivery by demonstrating quality and value in care, as financial disincentives will apply for failure to attest to Stage 3.

The comment period on the meaningful use stage 3 rules closes on May 29, 2015.

EHR Certification Criteria

The proposed 2015 edition of the EHR Certification Criteria is tied to ONC’s Shared Nationwide Interoperability Roadmap Version 1.0, which was unveiled earlier this year. Comments on the certification criteria are due June 30, 2015.

Consistent with the move to require full compliance and attesting to Stage 3 meaningful use by 2018, providers can use the 2014 edition of certified EHRs through 2017, but must adopt the proposed 2015 edition technology by 2018.

The interoperability agenda through 2017, as set forth in the Interoperability Roadmap, focuses on securely sending, receiving, finding and using a common clinical data set to improve health and healthcare quality with appropriate privacy protections. With interoperability continuing to present challenges for robust data exchange, and the House Energy and Commerce Committee’s 21st Century Cures proposal attempting to address the interoperability challenge, the ONC’s 2015 edition is acknowledging the need to promote interoperability. It does so by including certification criteria for data portability and the adoption of application programming interface functionality. The proposed rule would provide a pathway for the certification of health IT products for providers not currently eligible for incentive payments, such as long-term post-acute care and behavioral health providers. Finally, the proposed rule would make the ONC Health IT Certification Program available to other HHS, public and private programs to meet the specific needs of their programs and provide more flexibility to a wider range of health and healthcare systems and providers.