06-6689. Notice of Availability: Office of the National Coordinator for Health Information Technology (ONC) Interim Guidance Regarding the Recognition of Certification Bodies

AGENCY:

Office of the Secretary, HHS.

Authority: EO 13335 (“Incentives for the Use of Health Information Technology and Establishing the Position of the National Health Information Technology Coordinator”) and Pub. L. 109-149 (“Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2006).

SUMMARY:

This notice provides the public with information about the availability of a Certification Guidance Document (CGD) at http://www.hhs.gov/​healthit. The CGD explains the factors that ONC will use to determine whether or not to recommend to the Secretary of the Department of Health and Human Services (the Secretary) that he recognize a body for certification. Once recognized, that body will have Recognized Certification Body (RCB) status. The CGD will serve as guide for ONC as it evaluates applications for RCB status and seeks to provide all of the information a body would need to apply for and obtain such status. By publishing the CGD, HHS will ensure a transparent and open process as a basis for these recommendations.

To encourage a more widespread adoption of interoperable health information technology, the Department of Health and Human Services (HHS) published two final rules in August 2006 regarding certain arrangements involving the donation of interoperable electronic health records (EHR) technology to physicians and other health care practitioners or entities. The first, published by the Centers for Medicare & Medicaid Services (CMS), promulgated an exception to the physician self-referral prohibition. The second, published by the Office of Inspector General (OIG), established a safe harbor under the anti-kickback statute. In order for the donation of EHR technology to be protected under the exception and safe harbor provisions of these rules, the technology must be interoperable. The exception and safe harbor provide that EHR software will be “deemed to be interoperable if a certifying body recognized by the Secretary has certified the software no more than 12 months prior to the date it is provided to the [physician/recipient].” Both rules become effective 60 days after publication.

The Department will utilize notice and comment rulemaking to formalize and finalize the policies and procedures that will govern whether ONC will recommend to the Secretary a body for RCB status. In the meantime, this guidance document identifies the factors to be considered by the Secretary in granting such recognition. In addition, the guidance sets forth an interim procedure that certifying bodies should follow in obtaining recognition by the Secretary. Until such time as the Department formalizes the procedure, a certifying body will be considered “recognized by the Secretary” if it has become an RCB in accordance with the interim guidance. The guidance document seeks to reduce uncertainty about key aspects of the certification body recognition process.

DATES:

Public comment may be submitted on or before October 3, 2006. Comments may be submitted via e-mail to [e-mail] or in written form to the address below.

ADDRESSES:

Steven Posnack, Program Analyst, Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, 330 C Street, SW., Switzer Building, Room 4090, Washington, DC 20201.

Please refer to this guidance document when submitting comments.

FOR FURTHER INFORMATION CONTACT:

Steven Posnack at 202-690-7151.

Dated: July 31, 2006.

Karen Bell,

Acting Deputy National Coordinator for Health IT.