The Department of Health and Human Services has posted a pre-publication version of its proposed rule for Stage 3 of the electronic health record Meaningful Use Program. The proposed rule, which is available here, is scheduled for publication in the Federal Register on March 30. HHS says that the changes in Stage 3 are intended to support its efforts to increase simplicity and flexibility in the program while driving interoperability and a focus on patient outcomes. Comments are due by May 29. HHS says that this will be the last stage of meaningful use. HHS has also published proposed 2015 EHR Certification criteria, available here.
In its explanation of the proposed regulation, HHS reports that providers have expressed concern that the EHR incentive programs are complicated, not focused on clinical reality and workflow, and stifling to innovation in health IT development. In particular, providers are concerned about the number of Stage 1 and 2 objectives and measures that are becoming obsolete or lack any link to improving outcomes. HHS says that providers are performing higher than the thresholds for some of the measures, and want HHS to reduce the reporting burden on measures that have "topped out." They also expressed support for advanced functionality that would offer value to providers and patients, and for flexibility in implementing objectives. Providers in health systems and large group practices expressed frustration about the burden of having to compile multiple reports spanning multiple stages and objectives.
Meaningful Use Reporting. The proposed Stage 3 meaningful use rule would address these concerns by—
- Requiring all providers to report on the same meaningful use level, regardless of their prior participation, in 2018 and beyond. Providers would have the option of reporting under Stage 3 for 2017, or under the stage currently scheduled – so a provider in its first year of Stage 2 in 2016 could choose to remain in Stage 2 in 2017 or elect to move to Stage 3.
- With the exception of Medicaid providers in their first reporting year—
- moving all providers from the federal fiscal year to calendar reporting year beginning with 2017 (future regulations may require a separate report for the last calendar quarter of 2016); and
- requiring all providers to attest on the basis of a full year of data for 2018 and subsequent years. This would be optional for 2017.
Participants in the Medicaid incentive program could still report on a 90-day period in their first year.
- Establishing eight objectives with associated measures designed to—
- Align meaningful use reporting with national quality improvement efforts;
- Promote interoperability and health information exchange; and
- Focus on reducing cost, and improving access and quality.
Quality Reporting. Providers must report on Clinical Quality Measurements (CQMs) in order to receive incentive payments or avoid downward adjustment to their reimbursement. The proposed rule would—
- Align CQM reporting requirements with other quality reporting programs (such as PQRS and Hospital IQR) by including CQM reporting requirements with the annual rules that establish reporting requirements for other Medicare programs.
- Require electronic CQM reporting where feasible for Medicare providers beginning in 2018.
Certified EHR Technology. All providers would be required to use EHR technology certified to the 2015 Edition for the full 2018 EHR reporting period. The proposed 2015 certification criteria are also now available.
The Stage 3 Criteria: HHS says that its proposals for Stage 3 would continue the precedent of focusing on the advanced use of certified EHR technology. They would reduce the reporting burden; eliminate measures that are now redundant, duplicative, and “topped out”; create a single set of objectives for all providers with limited variation between professionals and institutional providers; and provide flexibility within the objectives to allow providers to focus on implementations that support their practice. They would also eliminate paper-based measures, such as faxing a paper summary of care record.
The proposed rule now includes eight objectives with associated measures. Some of the measures still differ a little between professionals and hospitals, and most of them have qualifications and exceptions. The proposed objectives (with a general summary of the measures) are:
1. Protect Patient Health Information. This measure would require the implementation of appropriate technical, administrative, and physical safeguards, including a security risk analysis, implementing security updates if necessary, and correcting identified security deficiencies.
2. Electronic prescribing. Professionals would be required to generate and transmit electronic prescriptions for more than 80 % of permissible prescriptions using certified EHR technology (CEHRT). Hospitals would be required to transmit more than 25% of discharge medication orders electronically.
3. Clinical decision support. This measure would require providers to implement five clinical decision support interventions related to four or more clinical quality measures at a relevant point in patient care for the entire EHR reporting period. Providers would also be required to enable and implement the functionality for drug-drug and drug-allergy interaction checks for the entire EHR reporting period.
4. Computerized provider order entry. Providers would be required to use computerized provider order entry for medication, laboratory, and diagnostic imaging orders directly entered by appropriately licensed and credentialed healthcare professionals for more than 80% of medication orders, 60% of laboratory orders and 60% of diagnostic imaging orders.
5. Patient access to electronic health information. This objective would require providers to give more than 80% of their patients (or their representatives) access to view online, download, and transmit their health information, or retrieve their health information through an application-program interface (API), within 24 hours of its availability. Providers must also use clinically relevant information from CEHRT to identify patient-specific educational resources and provide electronic access to those materials to more than 35% of their patients.
6. Coordination of care through patient engagement. Providers would be required to use the communications functions of CEHRT to engage with patients or their authorized representatives about the patient’s care. Providers need only meet two of the three measures under this objective. The measures are:
- More than 25% of patients (or their representatives) actively engage with the provider’s EHR, or access their information through a certified API from other applications or devices;
- A secure message is sent to more than 35% of patients or their representatives;
- Patient-generated health data or data from a nonclinical setting is incorporated into the certified EHR technology for more than 15% of patients.
7. Health information exchange. This objective would require providers to provide a summary of care record when transitioning or referring a patient to another setting of care, to retrieve a summary of care record at the first patient encounter with a new patient, and to incorporate summary of care information from other providers into their EHR using the functions of CEHRT. There are three related measures; providers must attest to all of them, but need only meet two:
- The provider must generate an electronic summary of care record and exchange it electronically for more than 50% of transitions of care and referrals;
- The provider must incorporate another provider’s summary of care record into its EHR for more than 40% of transitions or referrals that the provider receives;
- The provider must perform a clinical information reconciliation relating to medication, medication allergies and current problem list for more than 80% of new patients or referrals.
8. Public health and clinical data registry reporting. Providers would be required to be in active engagement with a public health agency or clinical data registry to submit electronic public health data in a meaningful way using CEHRT. Providers would have to attest to four of six measures, relating to :
- Immunization registry reporting;
- Syndromic surveillance reporting from an emergency or urgent care department;
- Reporting of reportable conditions;
- Public health registry reporting;
- Clinical data registry reporting;
- Electronic reporting of reportable laboratory results.
Hooper, Lundy & Bookman provides a range of legal services relating to reimbursement, health information technology, and health information privacy and security. For more information, please contact: In San Francisco, Paul Smith, Steve Phillips or Felicia Sze; in Los Angeles, Hope Levy-Biehl, Amy Joseph or Eric Chan; and in Washington, D.C., Bob Roth.