All stakeholders affected by the federal government's interrelated development of standards and protocols under HIPAA, the HITECH Act, and the Patient Protection and Affordable Care Act should closely monitor and, where possible, provide input on their development.

On March 23, 2010, President Obama signed into law H.R. 3590, the Patient Protection and Affordable Care Act (the Act). This sweeping health reform legislation requires the U.S. Department of Health & Human Services (HHS) to develop interoperable and secure standards and protocols to facilitate the enrollment of individuals in federal and state health and human services programs, and authorizes grants to state and local governments to promote the implementation of health information technology (HIT) to facilitate enrollment in the programs. (See Sect. 1561 of the Act).

Once issued, the new standards and protocols may affect how health care providers conduct health plan eligibility verification transactions standardized under the Health Insurance Portability & Accountability Act of 1996 (HIPAA) as well as how providers comply with the Medicare and Medicaid electronic health record (EHR) incentive programs' "meaningful use" objectives and measures pertaining to use of an EHR for electronic insurance eligibility verification. The standards and protocols may also affect how vendors' EHR technology is certified as capable of enabling meaningful use.

HIT Enrollment Standards and Protocols

No later than 180 days after enactment, the HHS, in consultation with the HIT policy and HIT standards committees created by the Health Information Technology for Economic and Clinical Health Act (HITECH Act), is required to develop interoperable and secure standards and protocols that facilitate the electronic enrollment of individuals in federal and state health and human services programs. The standards and protocols must facilitate enrollment in such programs by providing individuals and their authorized representatives notification and verification of eligibility. The standards and protocols must also allow for the following:

Electronic matching against existing federal and state data, including vital records, employment history, enrollment systems, tax records and other data determined appropriate by HHS to serve as evidence of eligibility in lieu of paper-based documentation

Simplification and submission of electronic documentation, digitization of documents and systems verification of eligibility

Reuse of stored eligibility information (including documentation) to assist with retention of eligible individuals

Capability for individuals to apply, recertify and manage their eligibility information online, including at home, points of service and other community-based locations

Ability to expand enrollment systems to integrate new programs, rules and functionalities; to operate at increased volume; and to apply streamlined verification and eligibility processes to other federal and state programs

Notification of eligibility, recertification and other needed communication regarding eligibility, which may include communication via e-mail and cell phones

Other functionalities necessary to provide eligible individuals with a streamlined enrollment process

HHS must notify states of the standards or protocols that have been approved by the HIT policy and HIT standards committees. HHS may require, as a condition of receiving federal funds for enrollment HIT investments, that states and other entities incorporate the standards and protocols into the investments.

Grants for Implementation of Appropriate Enrollment HIT Development

The Act authorizes HHS to award grants (in amounts not specified) to state and local governments to develop new and adapt existing technology systems to implement HIT enrollment standards and protocols, reduce enrollment HIT maintenance costs, and eliminate or update legacy enrollment systems. HHS must ensure that enrollment HIT developed through such grants is made available to state and local governments and other entities meeting qualification standards determined by HHS.

Effect on HIPAA Standardized Transactions and Meaningful Use Requirements

Whether and to what extent the enrollment standards, protocols and HIT will affect the HIPAA-standardized health plan eligibility verification transaction, the requirements for EHR technology to be certified as capable of supporting "meaningful use" under the HITECH Act's Medicare and Medicaid EHR incentive programs, and the meaningful use requirements for eligible providers remains to be seen. It would be prudent for HHS to make enrollment standards and protocols consistent or aligned with the incentive programs' EHR technology certification criteria and meaningful use requirements in the functional areas covered by both (e.g., eligibility, interoperability and security) to maximize the significant investment the federal government is making to facilitate the adoption of a nationwide health information network. It will also enhance HIT vendors' ability to develop efficiently and expeditiously products that will enable providers and governmental payors to make prudent use of grant funds and other incentives provided under both the Act and the HITECH Act. All stakeholders affected by the federal government's interrelated development of standards and protocols under HIPAA, the HITECH Act and the Act should closely monitor and, where possible, provide input on their development.

For more information about the Medicare and Medicaid EHR incentive programs, see McDermott's White Paper " HHS Establishes the Initial Pathway for Qualifying for HITECH Act Incentives Dollars for Meaningful Use of Certified Electronic Health Record Technology " and "BNA Insights: Toward Achieving Meaningful Use: HHS Establishes Certification Criteria for Electronic Health Record Technology ."

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