CAP Seeks Carve Out From EHR Safe Harbor

The College of American Pathologists (CAP) is urging the Department of Health and Human Services (HHS) to carve out laboratories and pathologists from a proposed extension of the safe harbor exception for donations of electronic health records (EHRs). In an April 22 letter to HHS, the college urged caution in using the exception to incentivize further interoperability “as the laboratory and pathology communities have seen significant abuses of these exceptions.” The letter was sent in response to proposed rules published in the April 10 Federal Register that would extend the sunset date for EHR exceptions under the Stark law and the anti-kickback safe harbor. The Centers for Medicare and Medicaid Services and the HHS Office of Inspector General have proposed extending the safe harbor until Dec. 31, 2016. It currently is scheduled to expire at the end of 2013. “The divergence between current laboratory EHR donation practices and those originally contemplated and intended under the safe harbor when established in 2006 is significant,” writes CAP. “It results in negative effects on access to health care services, quality, competition, cost to the federal health care programs and overutilization.” Donated software typically contains several modules that may be customized for the physician practice or specialty and provide for other capabilities outside of those protected under the safe harbor. The EHR software may also include a proprietary interface between the modules and EHRs to automatically populate the patient’s EHR with the data from the modules, including the results of all laboratory tests, among other features, says CAP. The EHR safe harbor requires that the software donated be interoperable to protect against donors who improperly attempt to create closed or limited EHR systems by offering technology that functionally or practically locks in business for the donor, notes CAP. In this situation, the EHR software package donated appears to be theoretically interoperable but does not function with the software packages and EHR systems of other providers who need to access clinical information contained in the records of the donated software. “The interface component is specific for the donor and functions only if specimens are referred to the donor’s laboratory rendering them inaccessible to other health care providers within patients’ continuum of care,” writes CAP. “The creation of these ‘walled gardens’ is completely at odds with the goals of the [proposal].” Other Concerns CAP also commented on the ways pathologists can improve coordinate patient-centered care with increased access to EHRs and the need for pathologists to have input into sharing and storing laboratory data in interoperable and multidirection EHRs, and verifying such systems. In addition, the college also discussed the extraordinary expenses laboratories face managing and sharing patient data electronically with each client’s individual EHR system interfaces and urged HHS to identify funding streams to cover the costs of multiclient laboratory interfaces and maintenance. “Electronic exchange of laboratory test orders and results represents an incremental requirement on laboratories for which there is no incremental reimbursement or compensation,” the college writes. “Laboratories must pay to establish electronic connections with EHRs. In addition, there are disparities among laboratories in their ability to pay for and to support interfaces. Creating some type of incentive or reimbursement model that [incentivizes] (or reduces the burden to) laboratories could foster the implementation of electronic exchange.”