May 29, 2015 Andrew Slavitt Centers for Medicare and Medicaid Services Department of Health and Human Services Hubert H. Humphrey Building, Room 445 - G 200 Independence Avenue SW Washington, DC 20201 Attention: Proposed rule: Electronic Health Record Incentive Program- Meaningful Use Stage 3 Dear Mr. Slavitt: On behalf of the National Association of County and City Health Officials (NACCHO), I appreciate the opportunity to respond to the notice of proposed rulemaking (NRPM) for the Medicare and Medicaid Programs; Electronic Health Record Incentive Program Stage 3 (Meaningful Use Stage 3). NACCHO is the voice of the 2,800 local health departments across the country. These city, county, metropolitan, district, and tribal departments work every day to ensure the safety of the water we drink, the food we eat, and the air we breathe. NACCHO promotes national policy, develops resources and programs, advances health equity, and supports effective local public health practice and systems. NACCHO is very supportive of electronic health record (EHR) adoption and investments in the nation s health information technology (IT) capacity. Effective and efficient systems enable local health departments to perform the following critical functions: Monitor chronic diseases such as childhood asthma or diabetes, and outbreaks of infectious diseases, such as Salmonella. Communicate important health information and notify the public about local emergencies. Evaluate policies, programs and services to ensure they are aligned with the community s needs. Limit dangerous and costly prescribing errors and environmental risks. Communicate with physicians about practice and disease patterns and manageme nt. When disease outbreaks or disasters strike, health IT helps ensure that vital public records are not lost and enables local health departments to act swiftly and in coordination with other firstresponder agencies such as police, fire departments, and emergency medicine. NACCHO emphasizes the importance of programs such as Meaningful Use (MU) Stage 3 that encourage the development of health IT systems that are interoperable with local public health agencies. Meaningful Use provides a strong incentive to hospitals and providers to exchange data with local health departments. In order to meet the Federal Health IT s Strategic Plan and Interoperability Roadmap s goal of advancing the health and wellbeing of communities, hospitals and providers must be abl e to share clinical data with local health departments.
NACCHO urges the Centers for Medicare and Medicaid Services (CMS) to be mindful of the significant barriers to adoption of interoperable health IT systems among public health stakeholders. Local health departments all over the United States have experienced a decline in workforce capacity, with the total public health workforce shrinking 15% since 2008. * The public health community is committed to being as responsive as it can to the pressing needs of health care providers with regard to Meaningful Use. The lack of dedicated funding for public health agencies (PHAs) to upgrade information systems and add staff is a very real challenge. Since Medicaid funding for infrastructure is one of the few sources open to PHAs, NACCHO asks for continued CMS support in making that funding mechanism available, encouraging state Medicaid programs to collaborate with PHAs, and taking other actions that reduce barriers to use of this funding to build public health information infrastructure. NACCHO also supports the Joint Public Health Informatics Taskforce s (JPHIT s) leadership on this topic. JPHIT has recently submitted public comments on the CMS NPRM for Meaningful Use Stage 3 that reflect the broad perspectives of nine national public health associations. As a founding member and cochair of JPHIT, NACCHO applauds JPHIT s leadership on an issue so vital to the nation and concurs with its recommendations. General Comments: Objective 8: Public Health and Clinical Data Registry Reporting Reference: 80 FR 16762-80 FR 16763 NACCHO is pleased to see continued support for core public health data exchange transactions among healthcare providers and PHAs in Stage 3. Such transactions are essential to realizing public and population health improvements through the Health Information Technology for Economic and Clinical Health Act. NACCHO understands and appreciates the motivation to streamline reporting and support the ability for a wide diversity of providers to meet MU criteria in the consolidated Public Health and Clinical Data Registry Reporting objective. However, the final rule must be clarified to ensure that the progress made by providers, hospitals, and PHAs for core public health reporting measures under Stage 1 and 2 will continue in Stage 3. Immunization registry reporting, syndromic surveillance, case reporting, and electronic laboratory reporting support core public health functions and data needs. Stage 3 should not create competition among the jurisdictional agencies and programs for EHR data, nor should it result in providers discontinuing reporting relationships established through Stage 1 and 2 efforts. We elaborate on this concept, and suggest alternatives in subsequent comments. Overview of Proposed Objective 8 Reference: 80 FR 16763-80 FR 16763 Replacement of "on-going" submission with "active engagement" NACCHO supports describing the Objective 8 requirement as active engagement." Replacing "on-going submission" with "active engagement" is an improvement, but the requirement needs further clarification to sufficiently describe the necessary steps for building and maintaining useful public health data exchanges among healthcare providers and local health departments. Definition of "active engagement" NACCHO recommends two actions to further clarify the definition. First, the regulation should state a clear definition for active engagement. Specially, as discussed in the NPRM, "active engagement" should * National Association of County and City Health Officials. (2014). Local Health Department Budget Cuts and Job Losses: Findings from the 2014 Forces of Change Survey. Retrieved February 6th, 2015, from http://www.naccho.org/topics/research/forcesofchange/ 2
mean that the provider is either sending, or in the process of moving towards sending, production data to a PHA or CDR. Second, the regulation should define production data to promote the submission of data that are of sufficient quality for public health use. Specifically, "production data" should be defined as complete, accurate, and timely data that conform to jurisdictional laws and practices. Proposed Objective 8 Measures Reference: 80 FR 16763-80 FR 16764 Proposal for Stage 3 public health objective NACCHO is greatly concerned that the proposed method for consolidating Stage 2 public health and specialty registry objectives into a single Stage 3 objective (i.e., Objective 8) will undermine the investments and gains Stages 1 and 2 have established. While we support the consolidation to simplify the programs and increase provider flexibility, we do not support the following aspects of the Stage 3 proposal: 1. An absence of core and menu, or mandatory and optional, public health reporting relationships for meaningful use. 2. The large allowance of flexibility to eligible professionals (EPs), eligible hospitals (EHs) and critical access hospitals (CAHs) in measure selection. 3. The introduction of an ambiguous clinical data registry (CDR) measure. We discuss the issues and then present recommendations to improve Objective 8 for public and population health in Stage 3 below. Issues with the proposal There are three issues with the proposed approach to consolidating Stage 2 public health and specialty registry objectives for Stage 3. First, the proposal consolidates the Stage 2 objectives without carrying forward the concepts of mandatory ("core") and optional ("menu") reporting to Stage 3. Using EHR data in immunization, syndromic surveillance, reportable conditions and electronic laboratory results reporting benefits core public health services, whereas the benefits of Public Health Registries (PHRs) and CDR reporting are narrower. As EPs, EHs, and CAHs proceed to Stage 3, the core public health reporting relationships must continue, while modernization in specialty relationships is promoted. The consolidation method does not sufficiently prioritize the Objective 8 measures for Stage 3. Second, the proposal gives EPs, EHs, and CAHs too much flexibility in measure selection. The flexibility offered to EPs, EHs and CAHs could jeopardize existing transmission of public health data by not continuing the required measures from Stage 2. The proposed ability for EPs, EHs and CAHs to select 3 or 4 measures from 5 or 6 measures makes it possible for them discontinue core Stage 1 and 2 public health reporting relationships. Furthermore, the proposed ability for providers to count reporting to PHRs and CDRs up to 3 or 4 times makes it possible for EPs, EHs, and CAHs to fulfill this objective without working with a local public health department. This is problematic because it completely removes any incentive for a provider to work with a local health department. The flexibility in the proposal is too great to successfully promote public and population health improvements at the local level in Stage 3. 3
Finally, clinical data registries (measure 5) are insufficiently defined. The proposed definition creates the false impression that CDRs and PHRs serve separate, non-overlapping purposes, when in fact CDRs and PHRs can and should serve to benefit larger population health goals. The proposed differentiation of CDRs and PHRs by ownership (i.e., whether or not a PHA operates the registry), fails to acknowledge those public health data registries that are emerging through public-private partnerships. Regardless of registry stewardship, it is imperative that public health reporting in Stage 3 benefit public and population health improvement efforts. The proposed introduction of PHRs as Stage 3 terminology supports this imperative. On the other hand, the CDR definition fails to sufficiently set an expectation that CDR reporting will benefit public health. Recommendations to improve proposal NACCHO recommends changes to the proposed objective that will address the issues discussed above, and provide greater assurance that Stage 3 will promote improvements in public and population health outcomes. Specifically, NACCHO recommends the following actions: 1. Measures 1, 2, and 3 be mandatory or core measures for EPs. 2. Measures 1, 2, 3, and 6 be mandatory or core measures for EHs and CAHs. 3. Provisions be made to provide EPs, EHs, and CAHs with flexibility in reporting to PHRs that also benefit their prevention efforts (we offer a couple of alternatives for your consideration in the Appendix). 4. PHRs be defined as registries that are operated by, in service of, or in partnership w ith a public health agency. 5. Either the proposed CDR measure be significantly reworked to address the aforementioned issues, or consolidated into the public health registry measure. Measure 1 - Immunization Registry Reporting Reference: 80 FR 16764-80 FR 16764 NACCHO fully supports the inclusion of bidirectional exchange for immunization registry interoperability in Meaningful Use Stage 3, as this represents significant value for providers and patients alike. Over half of immunization information systems (IIS) report to the Centers for Disease Control and Prevention (CDC) that they currently have HL7 2.5.1 query functionality live in production, and this number is increasing rapidly as IIS fully adopt HL7 2.5.1 release 1.5. The value IIS provided to local health departments in carrying out vital public health activities is substantial. Measure 2 - Syndromic Surveillance Reporting Reference: 80 Reference: FR 16764-80 FR 16765 NACCHO does not support exclusion option (1). Syndromic surveillance accommodates surveillance for all hazards. As a result, it is very difficult to provide exclusions by disease or condition. We suggest changing the exclusion (1) to the following wording: (1) operates in a jurisdiction that does not accept syndromic surveillance data for the EPs specialty or practice type as determined by the public health agency in that jurisdiction (as noted in the central repository). Measure 3 - Case Reporting Reference: 80 FR 16765 4
NACCHO applauds CMS for including public health case reporting into the third and final stage of the Meaningful Use program. We know there are many pressures to limit existing, not to mention new, meaningful use criteria, but it is the government s responsibility to insure that the public s safety is protected. And the core function of reporting cases of certain conditions to local health departments, which is required by law in every jurisdiction in the United States, is a critical and, currently neglected public need. CMS Meaningful Use Stage 3 Criterion for case reporting is critical for monitoring disease trends and supporting public health surveillance systems needs as they manage disease outbreaks and environmental emergencies. The CMS NPRM cites the case for electronic case reporting from the perspective of improved yield, burden-reduction, increased timeliness, and improved completeness for reports. It correctly cites the need for EHRs to send initial case reporting data and to also support subsequent requests for supplemental data from public health. NACCHO also notes the importance of health departments notifying health care providers of reportable conditions in patients they are treating and to which they have been exposed. Closing the information loop and providing useful, contextualized, public health information to clinical care has been long sought by providers. Case reporting also needs to facilitate the delivery of public health lab results and other data to providers of care. NACCHO appreciates the opportunity to provide comments on the proposed rule for Meaningful Use Stage 3. Local health departments must be included in any federal plan to expand the use of interoperable health IT systems. Meaningful Use will play a vital role in improving the public s health and can greatly increase the use of modern public health IT throughout the United States. NACCHO looks forward to continuing to support CMS s efforts as a partner in this effort. Sincerely, Lamar Hasbrouck, MD, MPH Executive Director 5
APPENDIX Joint Public Health Informatics Task Force Recommendations Alternative provisions for the public health reporting objective in Stage 3 Each of the following alternatives address recommendations to improve the public health objective for Stage 3. At this time, JPHIT is not recommending one alternative over another, but rather providing these as concrete suggestions to provoke conversation, and the eventual identification of a solution. Table 1: Consolidate PHR and CDR into one objective, and prioritize public health agency reporting. Maximum number of times measure may Measure count toward the objective EP EH or CAH Measure 1 Immunization Registry Reporting 1 1 Measure 2 Syndromic Surveillance Reporting 1 1 Measure 3 Case Reporting 1 1 Measure 4 Public Health Registry Reporting 3 4 Measure 5 Clinical Data Registry Reporting 3 4 Measure 6 Electronic Reportable Laboratory Results NA 1 For each measure 1, 2 or 3 exclusion an EP may attest to Measure 4 or 5; e.g., If EP has an exclusion to Measure 2 and not for Measure 1 and 3, then the EP may do either Measure 4 or 5 one time to reach the total 3 measures for the objective. For each measure 1, 2, 3 or 4 exclusion an EH or CAH may attest to Measure 4 or 5; e.g., If EH has an exclusion to Measure 3 and 6, and not for Measure 1 and 2, then the EH may do either Measure 4 or 5 once to reach the total 4 measures for the objective. 6
Table 2: Consolidate PHR and CDR, retain reporting to public health agencies as core, and allow flexibility with menu measures. Core and Menu Measures for Public Health Measure Reporting Objective EP EH or CAH ** Measure 1 Immunization Registry Reporting Core Core Measure 2 Syndromic Surveillance Reporting Menu Core Measure 3 Case Reporting Core Core Measure 4 Public Health Registry Reporting Menu Menu Measure 5 Clinical Data Registry Reporting Menu Menu Measure 6 Electronic Reportable Laboratory Results NA Core EPs must complete all core measures, and 2 menu measures to meet the objective. Measure exclusions may count toward the objective. ** EHs and CAHs must all core measures, and 1 or 2 menu measures to meet the objective. Measure exclusions may count toward the objective 7
Table 3: Separate PHR and CDR, and prioritize reporting to public health agencies. Core and Menu Measures for Public Health Measure Reporting Objective EP EH or CAH Measure 1 Immunization Registry Reporting Core Core Measure 2 Syndromic Surveillance Reporting Menu Core Measure 3 Case Reporting Core Core Measure 4 Public Health Registry Reporting Menu Menu Measure 5 Electronic Reportable Laboratory Results NA Core EPs must complete all core measures, and 1 menu measure to meet the objective. Measure exclusions may count toward the objective. EHs and CAHs must all core measures, and 1 menu measure to meet the objective. Measure exclusions may count toward the objective. 8