Update on Federal Health IT Bill: Protection For Certain Hospital/Physician Health IT Arrangements
08/02/2006The U.S. House of Representatives voted on July 27 to approve legislation (H.R. 4157) aimed at promoting health information technology through coordination between the public and private sectors. The House bill must be reconciled with a Senate version passed in November 2005 (S. 1418), so additional revisions are expected. The key elements of the legislation are:
- Creation of a permanent Office of the National Coordinator for Health Information Technology within the Department of Health and Human Services (HHS) to coordinate federal government activities relating to health information technology and oversee a nationwide strategic plan for implementation of interoperable health information technology in the public and private sectors
- Directing the Secretary of HHS to study and report on the continuity of federal and state laws on confidentiality and security of health information technology culminating in a report to Congress within 18 months on whether there should be a single federal set of standards
- Directing the Secretary of HHS to promulgate a final rule for upgrading specified Accredited Standards Committee X12 (ASC X12) and National Council for Prescription Drug Programs (NCPDP) telecommunications standards for transactions occurring on or after April 1, 2009, and for upgrading International Statistical Classification of Diseases and Related Health Problems, 9th Revision (ICD-9) to ICD-10 codes by October 1, 2010.
- Creation of a safe harbor under the federal anti-kickback law and an exception under the Stark regulations allowing hospitals and other health care providers (providers) to (a) provide health information technology and related training services, including hardware, software, license rights, intellectual property and equipment, to physicians and (b) prescribe conditions under which the technology and training would not be considered a prohibited payment made as an inducement to reduce or limit services. The safe harbor and exception would require that any such arrangement be in writing and that any remuneration be given without conditions that (i) limit the use of the technology to services provided by the physician to individuals receiving services at the provider; (ii) limit the use of the technology in conjunction with other health information technology; and (iii) take into account the volume or value of referrals (or other business generated) by the physician to the provider. Depending on how the enforcement agencies interpret and apply this legislation, it is potentially broader than the regulatory safe harbors and Stark exceptions proposed by the Office of Inspector General and the Centers for Medicare and Medicaid Services, respectively, in October 2005.
The reconciliation of the House and Senate bills must address the Senate bill’s lack of provisions concerning the anti-kickback safe harbor, the Stark exception, and the upgrading of the telecommunications standards and ICD-9 codes. We will continue to keep you apprised of significant developments relating to this bill or to health information technology.
