E9-31216 I C 1

1. ONC's Processes Prior to the HITECH Act

Prior to the enactment of the HITECH Act, ONC's processes consisted of the ``acceptance and ``recognition of HIT standards, implementation specifications, and certification criteria for the electronic exchange of health information and electronic health records.

This prior process and its participants are described in further detail below.

Chartered in 2005, the American Health Information Community (AHIC), a Federal advisory committee, was charged with making recommendations to the Secretary on how to accelerate the development and adoption of HIT.

Until its sunset in November 2008, AHIC advanced to the Secretary several recommendations related to standards, implementation specifications, and certification criteria.

To structure those recommendations, AHIC identified ``use cases'' to prioritize areas in need of harmonized standards and to enable ONC to guide the work of organizations with specific expertise in those priority areas.

A use case provided a description of the activity of stakeholders, a sequence of their actions, and technical specifications for systems and technologies involved when the actors engage in responding to or participating in such activity.

Created in 2005 by the American National Standards Institute (ANSI) under a contract with HHS, the Healthcare Information Technology Standards Panel (HITSP)--a cooperative partnership of more than 500 public and private sector organizations--began its work to take into account AHIC identified use cases, as directed by ONC.

HITSP was established for the purpose of harmonizing and integrating a widely accepted and useful set of standards to enable and support interoperability among healthcare software systems and the organizations and entities that utilize the systems.

HITSP also became a primary forum for HIT standards harmonization after the Consolidated Health Informatics (CHI) initiative, which began in October 2001 as a collaborative effort to adopt Federal government-wide interoperability standards to be implemented by Federal agencies, was gradually phased out.

The CHI initiative adopted several standards that were fed into and reused as part of HITSP's standards harmonization processes.

As a result, over the course of its three-year existence, AHIC sought testimony from HITSP representatives several times on their standards harmonization work in order to inform potential recommendations for the Secretary.

In many cases, after a presentation by HITSP, AHIC would make recommendations to the Secretary regarding standards and implementation specifications for recognition.

The Secretary would subsequently review those recommendations and determine whether to recognize some or all of the recommended standards and implementation specifications.

Executive Order 13410 (71 FR 51089) acknowledged that the Secretary recognizes interoperability standards for use by certain Federal agencies.\1\

This Executive Order also directed those Federal agencies, to the extent permitted by law, to require in their contracts and agreements with certain organizations the use, where available, of health information technology systems and products that meet recognized interoperability standards.

Executive Order 13410 was issued on August 28, 2006, to, among other goals, ensure that health care programs administered or sponsored by the Federal government promoted quality and efficient delivery of health care through the use of health information technology.

On March 1, 2007, January 23, 2008, and January 29, 2009, HHS published notices in the Federal Register (72 FR 9339, 73 FR 3973, 74 FR 3599, respectively) announcing either the Secretary's acceptance or recognition of certain standards and implementation specifications.

In an effort to assist with the implementation and adoption challenges associated with recognized standards, the Secretary chose to first ``accept and then formally ``recognize one year after acceptance, specified standards and implementation specifications.

This delay provided Federal agencies with additional time to prepare for Executive Order 13410's directive to ``utilize, where available, health information technology systems and products that meet recognized interoperability standards when they implemented, acquired, or upgraded ``health information technology systems used for the direct exchange of health information between agencies and with non-Federal entities.

--- FOOTNOTE 1 \1\ Executive Order 13410 defines ``agency to mean ``an agency of the Federal Government that administers or sponsors a Federal health care program.

It also defines ``Federal health care program'' as including ``the Federal Employees Health Benefit Program, the Medicare program, programs operated directly by the Indian Health Service, the TRICARE program for the Department of Defense and other uniformed services, and the health care program operated by the Department of Veterans Affairs.''

For purposes of the Executive Order, ``Federal health care program'' does not include ``State operated or funded federally subsidized programs such as Medicaid, the State Children's Health Insurance Program, or services provided to Department of Veterans' Affairs beneficiaries under 38 U.S.C. 1703.'' ---

The third participant besides AHIC and HITSP that played a role in ONC's prior processes was the Certification Commission for Health Information Technology (CCHIT).

Founded in 2004, CCHIT established the first comprehensive process to test and certify EHR technology.

After establishing a certification criteria development process that included diverse stakeholders and a voluntary, consensus-based approach, CCHIT began certifying ambulatory EHR technology in 2006.

Since 2006, CCHIT has expanded its certification program to include inpatient EHR technology, emergency department EHR technology, as well as its certification criteria for EHR technology to meet specific needs of certain health care providers/specialists (e.g., cardiovascular, child health).

On May 16, 2006, CCHIT presented its 2006 ambulatory EHR certification criteria to AHIC and after considering the criteria, AHIC recommended that the Secretary recognize CCHIT-identified certification criteria for functionality, interoperability, and security.

This recommendation informed the Secretary's decision to recognize the 2006 ambulatory EHR certification criteria for use by recognized certification bodies in conjunction with published final rules for exceptions to the physician self-referral law and safe harbors to the anti-kickback statute for electronic prescribing and EHR software arrangements (71 FR 45140 and 71 FR 45110, respectively).

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].''

These provisions of the EHR exception and safe harbor anticipated that:


 * (1) HHS would recognize one or more EHR certifying bodies, and
 * (2) HHS would recognize criteria for the certification of EHRs.

The Federal Register notice (71 FR 44295) describing the Secretary's recognition of these certification criteria was published on August 4, 2006.

Section 3004(b)(2) of the PHSA provides that in adopting an initial set of standards, implementation specifications, and certification criteria in accordance with section 3004(b)(1), the Secretary may adopt those standards, implementation specifications, and certification criteria that went through the process established by ONC before the date of the enactment of the HITECH Act.

We believe that in separately requiring the Secretary to adopt an ``initial set'' of standards, implementation specifications, and certification criteria under section 3004(b)(1) of the PHSA, Congress provided the Secretary with the discretion to adopt standards, implementation specifications, or certification criteria which had not gone through the prior process.

As described above, while the prior process included a significant body of work it did not encompass the entirety of the areas Congress requested the Secretary to focus on in the HITECH Act, nor did it envision the policies and capabilities that would be necessary for Certified EHR Technology to meet the proposed definition of meaningful use Stage 1 included in the Medicare and Medicaid EHR Incentive Programs proposed rule.

As a result, we have, after considering the input received through the recommendations of the HIT Policy Committee and HIT Standards Committee, adopted an initial set of standards, implementation specifications, and certification criteria to, at a minimum, support the achievement of what is being proposed for meaningful use Stage 1.

We have noted in section III of this rule, where applicable, those standards and implementation specifications that were previously accepted or recognized by the Secretary under this prior process and those that were not.

Due to our approach of aligning adopted certification criteria with the proposed definition of meaningful use Stage 1, the Secretary has decided not to adopt previously recognized certification criteria developed in 2006 as any of the certification criteria in this interim final rule.