Department of Health and Human Service (HHS) and Centers for Medicare and Medicaid Services (CMS)

In the previous blog post of our series on the Department of Health and Human Services’ (HHS) proposed Meaningful Use Stage 2 measures we provided our commentary with regard to the Notice of Proposed Rulemaking (NPRM) on Meaningful Use for 2014 regulations. As promised, in today’s post we will provide our commentary with regard to the NPRM for Health Information Technology (HIT): Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record (EHR) Technology. This is the sister rule to the Stage 2 Meaningful Use regulations; it describes the technical means to accomplish the measures outlined in the Stage 2 proposed rule. As with our previous commentary, we hope that HHS and CMS will heed our comments and recommendations, but rest assured no matter their final ruling on Meaningful Use Stage 2 measures, HealthFusion will be ready and Meaningful Use attestation will be as easy as always with MediTouch and our Meaningful Use Report Card®.

Below is our submitted commentary with regard to the NPRM for Health Information Technology (HIT).

HealthFusion® MediTouch EHR® Comments on Meaningful Use Stage 2 Proposed Rule for Health Information Technology

We appreciate the Department of Health and Human Services (HHS) and the Office of the National Coordinator for Health Information Technology (ONC) efforts with regard to the Stage 2 Notice of Proposed Rule Making (NPRM) for Health Information Technology (HIT): Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology. As a cloud-based Electronic Health Record (EHR) vendor we applaud the efforts of your department to further the adoption and integration of EHRs into the everyday practice of medicine.

The following are our comments with regard to the Stage 2 NPRM for Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology.

General Comments

We support the recommendations to create more uniformity with regard to data vocabularies across several of the measures (both new and old). However, in many cases we believe that the ONC should begin to provide more detail and assistance with cross-walking older coding systems that were permitted in Stage 1 to the more exclusive coding systems required in this Stage 2 NPRM. We agree with the HIT Standards Committee that, “A government ‘value set hosting entity’ distribute all the necessary vocabularies and code sets, making them available for download or real time query.” These code sets should assist vendors in making the transition from codes sets that were “allowed” in Stage 1 to the more restrictive code sets that are required in Stage 2. We urge the government to anticipate the issues related to converting existing allergy, medication, and problem lists to the Stage 2 code sets, and provide detailed guidance with regard to these conversions at the time the final rule is published.

We also advocate that the ONC make testing sites for vendors available ASAP after the final rule is passed, this way vendors will have ample time to prepare for Stage 2 certification.

We recommend that the Permanent Testing Bodies are selected so that they can begin testing with EHR vendors no later than the first quarter of 2013. This will assure EPs preparing for Stage 2 that their vendors are certified well before the 2014 deadline. We also recommend that the proposed testing start date be finalized ASAP.

Electronic Notes

Record electronic notes in patient records.

ONC recommends: “Additionally, we are providing the following clarifications for the electronic ‘search’ capability. ‘Search’ means the ability to search free text and data fields of electronic notes. It also means the ability to search the notes that any licensed health care professional has included within the EHR technology, including the ability to search for information across separate notes rather than just within notes.”

Recommendation: We agree with the notion of recording electronic notes in EHR technology that are searchable. We suggest clarification that searching across multiple notes will allow for certain constraints with regard to search to improve the performance of a search – example date range.

Family Health History

Record patient family health history as structured data.

“In defining family health history, this capability requires, at minimum, the ability to electronically record, change, and access the health history of a patient’s first-degree relatives. As proposed in the Stage 2 proposed rule, a first degree relative is a family member who shares about 50 percent of their genes with a particular individual in a family (first degree relatives include parents, offspring, and siblings).”

Recommendation: We agree with the notion of using SNOMED to record Family History Data, but we would ask that the ONC not move to the HL7 Pedigree standard or the Surgeon General XML format until such time that those standards become more mature.

View, Download, and Transmit to 3rd Party

Provide patients the ability to view online, download, and transmit their health information within 4 business days of the information being available to the EP.

“In addition to the view and download capabilities recommended by the HITSC, we propose to include a third specific capability in this certification criterion — the ability to transmit a summary care record to a third party. Given that this objective is about making health information more accessible to patients and their caregivers, we believe that patients should have another option available to access their health information. We also believe that in certain cases patients may want to direct their health care provider(s) to transmit a copy of their electronic health information to another entity the patient might use for centralizing their health information (e.g., a personal health record). This additional capability is consistent with, and supports, the right of access standard at 45 CFR 164.524 of the HIPAA Privacy Rule as expanded by section 13405(e) of the HITECH Act with respect to covered entities that use or maintain an EHR on an individual.”

Recommendation: We agree that patients should be permitted to transmit their health record to another entity, but we believe it places too much burden on the EP to be the party that transmits on behalf of the patient. Providers should provide the record and only transmit it to other entities as part of the normal healthcare workflow. The ONC should not burden providers with the additional tasks of being a relaying entity on behalf of their patients for the maintenance of the patient’s private personal health record portals. The ONC should make it the responsibility of the patient and the “other entity”, such as the patient portal, to transmit their record to that other entity.

“Coupled with this addition, we have proposed that EHR technology would need to be capable of transmitting a summary care record according to both transport standards we propose to adopt. These transport standards include the two transport specifications developed under the Direct Project.”

Recommendation: We believe the Direct Project is the correct next step in data exchange, since the national HIE infrastructure is not ready for the 2014 Stage 2 target date. While a storage and retrieval HIE model would be best, we understand that the infrastructure is still too immature. We believe the ONC needs to clarify how EPs of disparate EHR technologies will “look up” their counterparts so they can send them health information via the Direct Project protocols. The ONC needs to explain to healthcare technology vendors how a national network of physician “addresses” will become a reality.

“We propose to require EHR technology to be capable of enabling images formatted according to the Digital Imaging and Communications in Medicine (DICOM) standard 11 to be downloaded and transmitted to a third party. We believe this specific capability has the potential to empower patients to play a greater role in their own care coordination and could help assist in reducing the amount of redundant and duplicative imaging-oriented tests performed.”

Recommendation: Complex DICOM images can be very large, uploading, downloading, and storing those images on multiple data storage devices or sites may be costly, and point-to-point connectivity with multiple radiology centers will place an unfair burden on the EP. We know the radiologist that performed the study always stores the image; we propose that a secure hyperlink to the image, supplied by the radiologist and conveyed via the Direct Project standard, become the method of making DICOM images and radiology reports available to patients and ordering providers.

“For encounter diagnoses and procedures, we propose the use of ICD-10 (ICD-10-CM and ICD-10-PCS, respectively). We request comment, however, on whether we should be more flexible with this proposed requirement based on any potential extension of the ICD-10 compliance deadline or possible delayed enforcement approach. More specifically, we are interested in whether commenters believe it would be more appropriate to require EHR technology to be certified to a subset of ICD-10, either ICD-9 or ICD-10, or to both ICD-9 and ICD-10 for encounter diagnoses and procedures.”

Recommendation: Providers should not be required to use ICD-10 for encounter diagnoses until October 2014, and then ICD-9 should no longer be allowed. We believe that the procedure coding system used in Stage 1 should be the same in Stage 2.

Safety-enhanced Design

The International Organization for Standardization (ISO) defines usability as, “the extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency, and satisfaction in a specified context of use.”

Recommendation: Let market forces determine which EHR technologies are “effective” with regard to user satisfaction. Mandating the reporting of adverse events will discourage and not encourage EHR adoption. We recommend not including any of the proposed “Safety-enhanced design” requirements.

Clinical Decision Support

Use clinical decision support to improve performance on high-priority health conditions.

“We also propose to require the use of the HL7 Context-Aware Knowledge Retrieval (“Infobutton”) Standard, International Normative Edition 2010, for retrieving diagnostic or therapeutic reference information and specifically require the use of CDS with the incorporation of a summary care record.”

Recommendation: We agree with the HIT Standards Committee with regard to the use of the “Infobutton” standard (per their April 2012 minutes). We also propose that the “Infobutton” standard is optional, not a certification criteria, to encourage its adoption but also enable innovation. These comments also apply to the “Patient-specific education resources” specification.

Encryption of Data at Rest

Protect electronic health information created or maintained by the Certified EHR Technology through the implementation of appropriate technical capabilities.

The Medicare and Medicaid Programs; Electronic Health Record Incentive Program Stage 2 proposed rule specifically mandated encryption at rest for data housed in a secure data center. This ONC technical guide to those measures implies that encryption at rest applies only to end user devices.

Recommendation: Clarify whether data at rest on a server located at a secure data center must be encrypted and if yes, please reconsider this requirement as we believe it will slow down response times in large cloud-based EHR systems.

Transmission to Immunization, Public Health, and Cancer Registries

Recommendation: We recommend that the ONC tighten the message structures within the HL7 message, such that one single message works with all registries of the same type. Specifically, there should not be 50 different flavors of the HL7 2.51 format for 50 different states for each transmission type. In addition, to make transmission simple, the registries captioned above should be required to accept messages via the Direct Project messaging system only. This will reduce the burden on providers for making dozens of point-to-point connections with registries.

Smoking status types

Must be in SNOMED-CT® International Release version January 2012

Recommendation: Provide vendors with a uniform crosswalk of the Stage 1 smoking status to corresponding SNOMED code.