On Feb. 23, CMS released the much anticipated proposed rule on the Stage 2 requirements that health care providers must meet to achieve "meaningful use" of certified electronic health records under the Medicare and Medicaid EHR Incentive Programs.
The proposed rule covers a broad array of issues, including:
- Revisions to Stage 1 objectives and measures;
- New measures for Stage 2;
- Expanded clinical quality measures and reporting options;
- Medicare payment adjustments for health care providers who fail to demonstrate meaningful use;
- Details on meaningful use audit appeals;
- Guidance for states on their Medicaid EHR Incentive Programs; and
- Technical corrections.
One Year Delay for Stage 2 for Providers Who Were Meaningful Users in 2011 Formalized
In November 2011, HHS Secretary Kathleen Sebelius announced the administration's intention to delay the start of Stage 2 by one year -- from 2013 to 2014 -- for those providers who successfully demonstrated meaningful use under Stage 1 in 2011. CMS formally adopts the delay in the proposed rule.
Thus, most health care providers, regardless of the year in which they first demonstrate meaningful use, would remain in Stage 1 for two years. The exception to this is providers who attested to meaningful use in 2011 only under the Medicare program; this set of providers will remain in Stage 1 for three years.
CMS also announced its intent to release Stage 3 criteria in future rulemaking, but it does not include any specific details in the proposed rule.
Same Framework, More Rigorous Health IT Functional Objectives
As was the case in Stage 1, CMS proposes both a core set and menu set of objectives for Stage 2.
In Stage 1, eligible professionals (EPs) are required to meet 15 core objectives and five of 10 menu objectives to qualify for incentive payments. Under the proposed Stage 2 requirements, EPs would need to meet 17 core objectives and three of five menu objectives to qualify for incentive payments.
In Stage 1, eligible hospitals (EHs) and critical access hospitals (CAHs) are required to meet 14 core measures and five of 10 menu objectives to qualify for incentive payments. In Stage 2, EHs and CAHs would be required to meet 16 core objectives and two of four menu objectives to qualify for incentive payments.
All eligible health care providers may qualify for exemptions from specific objectives in certain circumstances.
Nearly all of the Stage 1 menu set objectives are incorporated into the Stage 2 core set of objectives with only two exceptions:
- Electronic submission of syndromic surveillance data to public health agencies becomes a core measure for EHs and CAHs but remains a menu set measure for EPs; and
- Record advance directives (EHs only) remains in the menu set.
Under the proposed rule, measure thresholds would be increased for nearly all objectives.
Based on feedback from providers, CMS data on provider experience with Stage 1 to date and recommendations from the Health IT Policy Committee, CMS also proposes eliminating, replacing or consolidating a number of existing Stage 1 objectives, as well as adding several new Stage 2 objectives.
Alignment with Health IT Policy Committee's Stage 2 Recommendations
In June 2011, the Health IT Policy Committee submitted its set of recommendations on Stage 2 to the Office of the National Coordinator for Health Information Technology. CMS' proposed rule incorporates many of those recommendations, including increasing thresholds on multiple measures; a requirement related to providing patients with online access to and the ability to download their personal health information (EHs, CAHs and EPs); use of secure electronic messaging to communicate with patients (EPs); and updating the objective related to data privacy and security protections to address "encryption of data at rest."
Policy Committee recommendations not adopted in the proposed rule include objectives related to electronic lab data, patient communication preferences, care plans and health team members, and the recording of electronic notes.
Measure Thresholds Increased
In Stage 2, the proposed rule would increase the measure threshold for the majority of objectives that have been retained from Stage 1. For example, the threshold for computerized provider order entry increases from 30% of only medication orders to 60% of medication orders plus laboratory and radiology orders.
Measure thresholds would remain the same in Stage 2 for only two of the objectives that have been retained from Stage 1:
- "Generate lists of patients by specific conditions;" and
- "Record advance directives."
Other objectives, such as "use EHRs to identify patient-specific education resources," would not see an increase in existing measure thresholds but would be made more rigorous through the inclusion of an additional measure. Specifically, the EP, EH or CAH would, in effect, be required to attest to meeting multiple measures in order to satisfy the one objective.
Eliminated/Replaced Stage 1 Objectives
CMS acknowledges continued provider confusion about meeting the Stage 1 objective "capability to exchange key clinical information." In its commentary, CMS questions the relative value of the measure as currently structured (to meet the objective, providers are only required to conduct a test, which does not have to be successful). As a result, CMS proposes to replace the Stage 1 objective with a new objective that would require the EP, EH or CAH that "transitions their patient to another setting of care or provider of care or refers their patient to another provider of care [to] provide [a] summary of care record for each transition of care or referral." CMS suggests that employing the new "transitions of care" objective in Stage 2 will be easier for providers to understand and will ultimately serve as a more effective impetus for increased information exchange.
CMS also proposes to replace three patient engagement objectives -- specifically those that require EPs, EHs and CAHs to provide their patients with an electronic copy of their health information or discharge instructions -- with new Stage 2 objectives that require EPs, EHs and CAHs to provide patients with the ability to view online, download and transmit their health information.
Consolidated Stage 1 Objectives
CMS proposes to combine multiple Stage 1 objectives into more unified Stage 2 objectives in the interest of reducing unnecessary accounting and reporting burden for providers. For example, the objectives of maintaining an up-to-date problem list, active medication list and active medication allergy list would no longer be separate objectives for Stage 2 and would instead be combined with the “summary of care objective” by including them as required fields in the summary of care. Additionally, the "drug-drug and drug-allergy interaction checks" objective would become one of the measures for the Stage 2 core objective "use clinical decision support," and "implement drug formulary checks" would be incorporated in the "e-prescribing" objective's related measure.
Addition of New Stage 2 Objectives
CMS proposes several new objectives for Stage 2 -- some of which would become part of the Stage 2 core set and others that would become part of the Stage 2 menu set. New Stage 2 core set objectives would include:
- A "patient online access to health information" objective for EPs, EHs and CAHs;
- An "electronic medication administration record (eMAR)" objective for EHs and CAHs; and
- A "secure electronic messaging" objective for EPs.
New objectives that would be included in the Stage 2 menu set include "accessibility of imaging results" and "record patient family history" objectives for EPs, EHs and CAHs and two objectives related to registry reporting for EPs.
Changes to Stage 1 Criteria
In addition to setting forth criteria for Stage 2, CMS also proposes changes to a handful of the existing Stage 1 criteria, which would apply to health care providers entering Stage 1 in the future. The purpose of the majority of the changes is to align requirements across Stages 1 and 2. These changes would not affect providers planning to attest to meaningful use in 2012.
Most of the changes proposed would be optional for Stage 1 in 2013 and required for Stage 1 beginning in 2014. They include the following:
- A change to the denominator for the CPOE measure;
- Modifications to the "Record Vital Signs" objective;
- The elimination of the requirement to perform a test of the certified EHR's ability to exchange key clinical information as detailed above;
- The replacement of the existing patient engagement objectives that require EPs, EHs and CAHs to provide their patients with an electronic copy of their health information or discharge instructions with the new Stage 2 objectives that require EPs, EHs and CAHs to provide patients with the ability to view online, download and transmit their health information (thus making the objectives the same in Stages 1 and 2 once Stage 2 begins); and
- The addition of "except where prohibited" to the regulation text of the Stage 1 public health objectives in an effort to encourage all EPs, EHs, and CAHs to submit electronic immunization data, even when not required by state/local law (required in 2013).
Plan To Better Align Clinical Quality Measures With Other Programs
As in Stage 1, EPs, EHs and CAHs are required to report on specified clinical quality measures in order to qualify for EHR incentive payments under Stage 2.
In 2013, EPs, EHs and CAHs would meet the same clinical quality measure reporting requirements currently required under Stage 1. EPs must report on three core or alternate core measures, plus three menu set measures, and EHs/CAHS must report on a standard set of 15 core measures.
In the proposed rule, CMS also articulates a long-term vision in which EHs, CAHs and EPs are eventually able to report clinical quality measures through a "single mechanism" for "multiple CMS programs."
As a first step, beginning in 2014, CMS proposes that EPs would meet a set of clinical quality measures that align with other programs, such as the Physician Quality Reporting System, Medicare Shared Savings Program, National Committee for Quality Assurance medical home recognition program and the Children's Health Insurance Program Reauthorization Act.
Beginning in 2014 for EHs and CAHs, CMS proposes a set of clinical quality measures that would align with the Hospital Inpatient Quality Reporting and the Joint Commission's hospital quality measures.
In the case of EHs, the measure set would include the current set of quality measures from Stage 1 but with an expanded reporting requirement and greater flexibility for providers to choose which measures to report. CMS' approach is similar for EPs, but the agency does recommend removing three current Stage 1 clinical quality measures for EPs due to overlap with other measures.
A key difference between Stage 1 and Stage 2 is that starting in 2014, one common set of clinical quality measures would apply for all EHs and CAHs, regardless of if the EH or CAH is in Stage 1 or Stage 2. EPs would be required to report on 12 clinical quality measures while EHs would be required to report on 24 measures. CMS seeks comment on a potential list of 125 proposed clinical quality measures for EPs, including new pediatric measures, an obstetric measure, behavioral/mental health measures and measures related to HIV medical visits and antiretroviral therapy, and 49 proposed measures for EHs and CAHs. CMS notes the final list of measures will likely be smaller.
The proposed rule also solicits public feedback on several mechanisms for electronic clinical quality measure reporting, including electronic reporting as a group and electronic reporting through existing quality reporting systems.
Implementation of Reimbursement Penalties for Failure to Achieve Meaningful Use
Beginning in 2015, health care providers who fail to demonstrate meaningful use are subject to reimbursement penalties or "payment adjustments" under Medicare. CMS proposes a process by which payment adjustments would be determined by a prior reporting period.
Specifically, CMS proposes that any successful meaningful user in 2013 would avoid payment adjustment in 2015. Also, any Medicare provider who first meets meaningful use in 2014 would avoid the penalty if the provider is able to demonstrate meaningful use at least three months prior to the end of the calendar or fiscal year (respectively) and meet specified registration and attestation requirements. CMS also proposes a small set of narrowly defined allowable exceptions to the payment adjustments.
ONC released a companion rule related to standards and certification criteria for Stage 2 on Feb. 24. Both rules are expected to be published in the Federal Register on or around March 7, after which there will be a 60-day public comment period. Final rules are expected sometime during the summer.