May 1, 2012

Farzad Mostashari, MD, ScM
National Coordinator for Health Information Technology
Department of Health and Human Services
Hubert H. Humphrey Building, Suite 729D
200 Independence Ave. SW
Washington, DC 20201

Re: 2014 Edition EHR Standards and Certification Criteria Proposed Rule (RIN 0991–AB82)

Dear Dr. Mostashari:

On behalf of The Hospital & Healthsystem Association of Pennsylvania (HAP), which represents approximately 250 member institutions across the Commonwealth of Pennsylvania, we appreciate the opportunity to comment on the 2014 Edition EHR Standards and Certification Criteria Proposed Rule published in the March 7 Federal Register (RIN 0991–AB82). While HAP strongly supports the adoption and use of electronic health record (EHR) to improve patient care, we have significant concerns with some of the Stage 2 meaningful use recommendations being proposed by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) proposed approach to standards specifications and EHR certification.

Congress established the Medicare and Medicaid EHR incentive programs in the American Recovery and Reinvestment Act of 2009 (ARRA) to provide much needed funds to support the transition to an “e-enabled” health care system. HAP shares the goal of the EHR incentive programs: advancing adoption and use of EHRs to improve health care by providing needed financial support. However, the vast majority of hospitals—more than 80 percent—have not yet met Stage 1, due to both the high bar set and market factors, such as increasing costs and limited vendor capacity. Evidence also suggests that the digital divide is widening, with larger hospitals reaching much higher rates of adoption than smaller and rural facilities.

Given the experience to date in Stage 1 in Pennsylvania, HAP is concerned that elements of the CMS and ONC proposed rules for changing meaningful use requirements and technology stand in the way of a successful program to support widespread adoption by all hospitals in our state. Many of the proposals put regulatory requirements ahead of actual experience with these technologies—an approach that will likely have unintended consequences. Our major concerns and recommendations regarding the ONC proposed rule are summarized below.

Technology Flexibility: HAP appreciates ONC’s recommendation for reducing the burden of providers needing to have software they do not need or plan to use. However, we believe this policy change should be effective when the ONC rule is finalized, rather than in 2014.

Certification Stages: HAP does not support ONC’s recommendation that all EHR technology certification be based on the most recent standards and certification criteria. Rather, we believe that certification requirements should be tied to a provider’s stage of meaningful use and not the calendar or fiscal year.

Certified EHR Technology: ONC should ensure that all future certification criteria for electronic health record technology be able to facilitate the completion of current and prior stage objectives and measures (i.e., backward compatible with earlier stage standards and criteria). This would allow providers that are in Stage 1 to choose which level of certification works best for them.

Clinical Quality Measure Accuracy: HAP appreciates ONC’s proposal to ensure the accuracy of clinical quality measures data collection and calculations as part of certification. However, we believe that for an EHR product to achieve certification it should demonstrate its capability to correctly calculate and report all clinical quality measures finalized by CMS. We recommend that ONC maintain the current requirement that vendors certifying for the hospital sector be tested for all clinical quality measures as part of certification (rather than just one). Note that we are recommending that CMS defer adding new measures until Stage 3, given all of the challenges hospitals have faced with these measures in Stage 1.

Health Information Exchange: HAP recommends that ONC work with testing bodies to develop robust testing of vendor products’ ability to conduct exchange that would be required for certification. This level of testing would eliminate the need for the CMS measure on providers related to their ability to share Consolidated Clinical Document Architecture at transitions in care with recipients using a different EHR vendor.

SNOMED: HAP believes that it is premature to require only Systematized Nomenclature of Medicine—Clinical Terms (SNOMED–CT®) for problem list coding. We support the optional use of the International Classification of Diseases, 10th Revision, Clinical Modification (ICD–10–CM) or SNOMED-CT for problem list coding. We also recommend that ONC conduct a systematic study of the benefits and costs of mandatory use of SNOMED and, if warranted, establish a plan for a more orderly transition over time that identifies resources needed to support adoption by providers.

Web Content Accessibility Guidelines: HAP recommends that ONC conduct a study of the feasibility and implications of the Web Content Accessibility Guidelines in the health care industry before requiring their use.

LOINC: Please confirm that the use of Logical Observation Identifiers Names and Codes (LOINC) is limited to “where available,” which would be consistent with Stage 1.

In addition to the issues identified above, HAP believes ONC needs to significantly increase its efforts to educate and support providers on the content and use of the standards they have put forward, as recommended by the HIT Standards Committee. We also feel that since eligible hospitals and providers are increasingly dependent on their EHR vendor’s ability to retool their products to meet changing certification requirements and have their products certified under new requirements, on a going-forward basis, ONC should publish final certification rules at least one year before vendors are required to be certified, and three years before providers need to be using the products.

Pennsylvania’s hospitals want to move toward a health care system where all hospitals meaningfully use EHRs to improve patient care and safety and achieve national goals for improved health. HAP believes the recommendations outlined in this letter, as well as, the American Hospital Association’s (AHA) more detailed comments fulfill the goals of the ARRA legislation to use stimulus funding to advance the use of health IT and offer a constructive and positive pathway to national EHR adoption. We urge you to accept these recommendations and include them in the final rule.

Thank you for the opportunity to share our concerns and comments. If you have any questions about HAP’s comments, please contact me at (717) 561-5344, or pbussard@haponline.org; or Martin Ciccocioppo, vice president, research, at (717) 561-5363, or martinc@haponline.org.

Sincerely,

PAULA A. BUSSARD
Senior Vice President
Policy and Regulatory Services