CHIME Questions Final Certification Rules

The College of Healthcare Information Management Executives (CHIME) has released the comments it will file with the Office of the National Coordinator (ONC) for Health Information Technology regarding the initial set of standards, implementation specifications, and certification criteria for EHR technology.

The proposed regulations, issued as an interim final rule by ONC, were unveiled on December 30, 2009, and responses were due back to the government earlier this week.

Previously, on February 26, CHIME filed its comments with the Centers for Medicare & Medicaid Services regarding the EHR Incentive Program. CHIME’s ONC letter closely parallels its comments to the CMS. The Ann Arbor, Mich.-based organization has 1,400 members representing chief information officers and other top IT executives at many of the nation’s largest hospitals.

In its comments on the interim final rule, CHIME emphasized the importance of certification for supporting providers’ efforts to achieve meaningful use, saying it gives “healthcare providers a degree of assurance that the products they purchase will perform aspromised...certification is meant to support providers, not pose an additional burden.”

CHIME’s comments place the lion’s share of responsibility on vendors that develop IT
products, which it says builds on past experience in the HIT space. The organization also urges ONC to provide more lead time as it creates future certification criteria, so as to provide more time for providers to implement new and upgraded systems in the future. Previously, in its comments to the CMS on meaningful use regulations, CHIME had requested that a “grandfathering provision” be implemented to grant certification to products that have already been certified by the Certification Commission for Health Information Technology.

CHIME noted that further clarification is needed in ONC’s interim final rule, particularly in describing how certification will apply to organizations that use multiple clinical systems as components to an overall EHR system. CHIME supports wording in the rule that requires only certification of individual EHR modules.

CHIME’s comments ask ONC to support a single standard for patient summary records; the current interim rule allows use of either the Health Level Seven (HL7) Clinical Document Architecture (CDA) Release 2 (R2) Level 2 Continuity of Care Document (CCD) or the ASTM Continuity of Care Record (CCR) to electronically exchange a patient summary record.

“CHIME disagrees with this approach and believes that the sharing of health information across providers is best facilitated with adoption of a single standard for patient summary records,” the comment letter states. “CHIME believes that the healthcare field is ready to transition to a single standard for patient summary records, and such a move will facilitate interoperability in a more timely fashion.” The organization believes the HL7 CDA CCD is more robust and easier to read.

Medication reconciliation requirements in the interim rule need to be adjusted so that providers can meet the requirement if clinical systems can “display simultaneously two or more medication lists and provide tools for the clinician to perform medication reconciliation and create a single medication list.”

For reporting quality data, CHIME advises against using the CMS Physician Quality Reporting Initiative (PQRI) 2008 Registry XML Specification, and the related implementation specifications, the PQRI Measure Specifications Manual for Claims and Registry. Instead, it suggests the continued development of quality data reporting standards, which are in process by HL7.

CHIME also seeks a standards-based approach for submitting data to public health agencies. Current proposals for submitting data provide wide latitude to agencies for determining the format in which they want to receive data.

In addition, CHIME comments on privacy and security standards included in the interim rule, particularly in areas of encryption and decryption of data, verification of data to ensure it hasn’t been altered in transit, and cross-enterprise authentication.

CHIME advises against placing too many requirements on data transmission within an organization. “Encryption of data in EHR databases and transactional systems would slow operation of the software, thus hindering adoption of EHRs by staff and physicians,” its comments state. “We ask that ONC and CMS carefully consider the risk vs. cost and performance issues during deliberations on this requirement.”

Source: College of Healthcare Information Management Executives