Recognition of Interoperability Standards has implications for anti-kickback, physician self-referral, HIPAA, federal purchases and government contracting.
In the January 23, 2008, Federal Register, the Secretary of the (HHS) formally published the recognition of the Healthcare Information Technology Standards Panel (HITSP) Interoperability Specifications as Interoperability Standards for Health Information Technology (HIT), available here. Recognition of the Interoperability Standards represents a key advance toward true interoperability of electronic health records (EHR) and for the electronic exchange of health information. The Interoperability Standards address three main areas: (1) laboratory results reporting, (2) biosurveillance and (3) consent management (termed "consumer empowerment").
The effects of recognition could be extensive and include the following:
Under certain exceptions and safe harbors to the physician self-referral law and the anti-kickback statute, interoperability is a mandatory attribute of donated electronic prescribing and EHR technology and services. Interoperability will be assessed under the recognized Interoperability Standards, regardless of whether donors choose to employ a certifying body or to self-certify.
Recognized certifying bodies that perform interoperability evaluations will incorporate the recognized Interoperability Standards into their assessment criteria and test procedures on an ongoing basis. For purposes of certain exceptions and safe harbors to the physician self-referral law and the anti-kickback statute, certifications must be performed within 12 months prior to the donee’s receipt of HIT items and services. As a result, donors and recipients of HIT items and services should confirm that their vendor(s) are successfully renewing their certifications under the applicable revised interoperability criteria, and if not, may need to consider suspending or terminating an HIT donation program if a vendor’s certification lapses.
The ability for consumers to manage their consents for the use and disclosure of their protected health information by and to health care providers is required under the recognized Interoperability Standards. Experience with EHR donation programs to date indicates that this required functionality is largely absent in the current marketplace.
Compliance with the Interoperability Standards will effectively become a prerequisite to marketing HIT systems for federal government use and for health information exchange between federal agencies and non-government entities. By executive order, agencies must utilize HIT systems that comply with the Interoperability Standards, where available.
Entities that transmit health information under government contracts can be expected to procure only systems that comply with the Interoperability Standards, as an executive order compels the contracting agencies to contractually require contractors to utilize HIT systems that comply with the Interoperability Standards, where available.
Recognition of these Interoperability Standards was performed under the authority of Executive Orders 13335 (available here) and 13410 (available here), which direct development of a strategic plan to guide U.S.-wide implementation of interoperable health information technology, and which direct government agencies to utilize health information technology systems and products that meet recognized interoperability standards, where available, when exchanging health information between agencies and with non-federal entities. They also contractually require health care providers, health plans or health insurance issuers to utilize health information technology systems and products that meet recognized interoperability standards, where available.
Providers that order and receive lab results electronically, medical laboratories and vendors that supply associated electronic systems should understand the interoperability standards and incorporate compliance to the standards into their system development and maintenance plans. Additionally, providers should understand the implications of the interoperability standards for their reporting obligations to Public Health Agencies and for enabling patients to manage their consents for the use and disclosure of their health information. Donors of EHR and electronic prescribing technology and services under certain exceptions and safe harbors to the physician self-referral law and the anti-kickback statute should re-evaluate their program and their supplier contracts to confirm that the donated items are certified for compliance to the Interoperability Standards no more than 12 months prior to receipt by the donee.
The recognition of the Interoperability Standards is a key advance that lays the groundwork for more efficient exchange of health information, and is an evolutionary step, rather than an abrupt departure from previous practices. It should be noted that the individual documents underlying the Interoperability Standards were drafted, reviewed and approved by various Standards Development Organizations (SDO) and by HITSP, all of which are composed of industry and stakeholder representation. Also note that CCHIT , which develops certification programs for assessing interoperability, has already incorporated elements of certain recognized Interoperability Standards into its 2007 and 2008 criteria, and adoption is expected to continue to be evolutionary over a period of two or more years. It should also be noted that Executive Order 13410 requires use of compliant systems "where available," rather than mandating immediate compliance, and instructs federal agencies to contractually require compliance to recognized Interoperability Standards in the normal contract cycle, rather than renegotiating agreements.
Many more initiatives are likely to follow over the next 12 months as the public and private sectors continue to cooperate to improve electronic exchange of health information.
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