Meaningful Use – Excerpts from Proposed Rules Affecting Syndromic Surveillance

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The following is excerpted from the proposed rules, posted form comment at http://www.ofr.gov/OFRUpload/OFRData/2012-04443_PI.pdf.  For convenience, the rules related to public health and syndromic surveillance are reproduced below, with a quick link to the PDF document for the citation.

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from pages 35 …

c.  State Flexibility for Stage 2 of Meaningful Use

We propose to offer States flexibility with the public health measures in Stage 2, similar to that of Stage 1, subject to the same conditions and standards as the Stage 1 flexibility policy.  This applies to the public health measures as well as the measure to generate lists of specific conditions to use for quality improvement, reduction of disparities, research or outreach.

In addition, whether moved to the core or left in the menu, States may also specify the means of transmission of the data or otherwise change the public health measure, as long as it does not require EHR functionality above and beyond that which is included in the ONC EHR certification criteria as finalized for Stage 2 of meaningful use.

We solicit comment on extending State flexibility as described for Stage 2 of meaningful use and whether this remains a useful tool for State Medicaid agencies.

d.  Stage 2 Criteria for Meaningful Use (Core Set and Menu Set)

We are proposing to continue the Stage 1 concept of a core set of objectives and a menu set of objectives for Stage 2.  In the Stage 1 final rule (75 FR 44322), we indicated that for Stage 2, we expected to include the Stage 1 menu set objectives in the core set.  We propose to follow that approach for our Stage 2 core set with two exceptions.  We are proposing to keep the objective of “capability to submit electronic syndromic surveillance data to public health agencies” in the menu set for EPs.  Our experience with Stage 1 is that very few public health agencies have the ability to accept ambulatory syndromic surveillance data electronically and those that do are less likely to support EPs than hospitals; therefore we do not believe that current infrastructure supports moving this objective to the core set for EPs.  We are also proposing  to keep the objective of “record advance directives” in the menu set for eligible hospitals and CAHs.  As we stated in our Stage 1 final rule (75 FR 44345), we have continuing concerns that there are potential conflicts between storing advance directives and existing State laws.

from page 84 …

(b) Objectives and Measures Carried Over (Modified or Unmodified) from Stage 1

Menu Set to Stage 2 Core Set

We signaled our intent in the Stage 1 final rule to move the objectives from the Stage 1 menu set to the Stage 2 core set. The HIT Policy Committee also recommended that we move all of these objectives to the core set for Stage 2.  We propose to include in the Stage 2 core set all of the objectives and associated measures from the Stage 1 menu set, except for the objective “capability to submit electronic syndromic surveillance data to public health agencies” for EPs, which would remain in the menu set for Stage 2.  As discussed later, we also propose to modify and combine some of these objectives and associated measures for Stage 2.

from page 118 …

(c)  Public Health Objectives

Due to similar considerations among the public health objectives, we are discussing them together.  Some Stage 2 public health objectives are in the core set while others are in the menu set.  Each objective is identified as either core or menu in the below discussion.

•  Capability to submit electronic data to immunization registries or immunization information systems except where prohibited, and in accordance with applicable law and practice.

•  Capability to submit electronic reportable laboratory results to public health agencies, except where prohibited, and in accordance with applicable law and practice.

•  Capability to submit electronic syndromic surveillance data to public health agencies, except where prohibited, and in accordance with applicable law and practice.

•  Capability to identify and report cancer cases to a State cancer registry where authorized, and in accordance with applicable law and practice.

•  Capability to identify and report specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice.

We are proposing the following requirements, which would apply to all of the public health objectives and measures.  We propose that actual patient data is required for the meaningful use measures that include ongoing submission of patient data.

There are a growing number of public health agencies partnering with health information exchange (HIE) organizations to facilitate the submission of public health data electronically from EHRs.  As we stated in guidance for Stage 1, (see FAQ at: https://questions.cms.hhs.gov/app/answers/detail/a_id/10764/kw/immunizations) we clarify that such arrangements with HIE organizations, if serving on the behalf of the public health agency to simply transport the data, but not transforming content or message format (for example, HL7 format), are acceptable for the demonstration of meaningful use.  Alternatively, if the intermediary is serving as an extension of the EP, eligible hospital or CAH’s Certified EHR Technology and performing capabilities for which certification is required (for example, transforming the data into the required standard), then that functionality must be certified in accordance with the certification program established by ONC.

•  An eligible provider is required to utilize the transport method or methods

supported by the public health agency in order to achieve meaningful use.

•  Unlike in Stage 1, a failed submission would not meet the objective.  An eligible provider must either have successful ongoing submission or meet exclusion criteria.

•  We expect that CMS,  CDC and public health agencies (PHA) will establish a process where PHAs will be able to provide letters affirming that the EP, eligible hospital or CAH was able to submit the relevant public health data to the PHA.  This affirmation letter could then be used by the EP, eligible hospital or CAH for the Medicare and Medicaid meaningful use attestation systems, as well as in the event of any audit.  We request comments on challenges to implementing this strategy. We will accept a yes/no attestation and information indicating to which public health agency the public health data were submitted to support each of the public health meaningful use measures.

Where a measure states “in accordance with applicable law and practice,” this reflects that some public health jurisdictions may have unique requirements for reporting and that some may not currently accept electronic data reports.  In the former case, the proposed criteria for this objective would not preempt otherwise applicable State or local laws that govern reporting.  In the latter case, EPs, eligible hospitals and CAHs would be excluded from reporting.

from pages 124 …

Proposed Objective:  Capability to submit electronic syndromic surveillance data to public health agencies except where prohibited, and in accordance with applicable law and practice.

This objective is in the Stage 2 core set for eligible hospitals and CAHs and the Stage 2 menu set for EPs.  The Stage 1 objective and measure acknowledged that our nation’s public health IT infrastructure is not universally capable of receiving syndromic surveillance data from Certified EHR Technology, either due to technical or resource readiness.  Given public health IT infrastructure improvements and new implementation guidance, for Stage 2, we are proposing that this objective and measure be in the core set for hospitals and in the menu set for EPs.  It is our understanding from hospitals and the CDC that many hospitals already send syndromic surveillance data.  The CDC has issued the PHIN Messaging Guide for Syndromic Surveillance: Emergency Department and Urgent Care Data [http://www.cdc.gov/ehrmeaningfuluse/Syndromic.html] as cited in the ONC proposed rule on EHR standards and certification.  However, per the CDC and a 2010 survey completed by the Association of State and Territorial Health Officials (ASTHO), very few public health agencies are currently accepting syndromic surveillance data from ambulatory providers, and there is no corresponding implementation guide at the time of this proposed rule.  CDC is working with the syndromic surveillance community to develop a new implementation guide for ambulatory reporting of syndromic surveillance information, which it expects will be available in the fall of 2012.  We anticipate that Stage 3 might include syndromic surveillance for EPs in the core set if the collection of ambulatory syndromic data becomes a more standard public health practice in the interim.

The HIT Policy Committee recommended making this a core objective for Stage 2 for EPs and hospitals.  However, we are not proposing to adopt their recommendation for EPs.  We specifically invite comment on the proposal to leave syndromic surveillance in the menu set for EPs, while requiring it in the core set for eligible hospitals and CAHs.

Proposed Measure:  Successful ongoing submission of electronic syndromic surveillance data from Certified EHR Technology to a public health agency for the entire EHR reporting period.

Exclusions:  Any EP, eligible hospital or CAH that meets one or more of the following criteria may be excluded from this objective: (1) the EP is not in a category of providers that collect ambulatory syndromic surveillance information on their patients during the EHR reporting period (we expect that the CDC will be issuing (in Spring 2013) the CDC PHIN Messaging Guide for Ambulatory Syndromic Surveillance and we may relay on this guide to determine which categories of EPs would not collect such information); (2) the eligible hospital or CAH does not have an emergency or urgent care department; (3) the EP, eligible hospital, or CAH operates in a jurisdiction for which no public health agency is capable of receiving electronic syndromic surveillance data in the specific standards required by ONC for EHR certification for 2014 at the start of their EHR reporting period; or (4) the EP, eligible hospital, or CAH operates in a jurisdiction for which no public health agency is capable of accepting the specific standards required for Certified EHR Technology at the start of their EHR reporting period.  As was described under the immunization registry measure, the third and fourth exclusions do not apply if the public health agency has designated an HIE to collect this information on its behalf and that HIE can do so in the specific Stage 2 standards and/or the same standard as the provider’s Certified EHR Technology.  An urgent care department delivers ambulatory care, usually on an unscheduled, walk-in basis, in a facility dedicated to the delivery of medical care, but not classified as a hospital emergency department.

Urgent care centers are primarily used to treat patients who have an injury or illness that requires immediate care but is not serious enough to warrant a visit to an emergency department.  Often urgent care centers are not open on a continuous basis, unlike a hospital emergency department which would be open at all times.