The Department of Health and Human Services (HHS) is taking regulatory steps to encourage the dissemination of Health Information Technology (HIT). The changes are intended to advance the use of electronic health records and e-prescribing by physicians, pharmacists and other health care providers.

Under two separate final rules published on Aug. 8, health care providers who wish to donate HIT technology and services will be able to provide those items to recipients without fear of violating federal self-referral and anti-kickback rules. Donors may include hospitals, group practices, Medicare Advantage plans and other entities that bill Medicare for covered services.

Until now, the giving or accepting of valuable technology and services could result in violations of the federal physician self-referral prohibition and anti-kickback laws. The new rules outline a framework for providing technology and services that eliminate self-referral and anti-kickback concerns.

Under the new rules, donors who meet certain requirements may provide software, information technology and training services to recipients for free or at a greatly reduced price. In addition, hardware given to promote the use of electronic prescriptions will be allowed in specific circumstances.

The changes come in parallel rules published by the Centers for Medicare and Medicaid Services (CMS) and the HHS Office of Inspector General (OIG). The CMS rule (71 Fed. Reg. 45140) creates an exception to the physician self-referral law (also known as the Stark Law). The OIG rule (71 Fed. Reg.45110) creates a regulatory safe harbor from the federal anti-kickback law.

To be covered by the exception and safe harbor, the transferred technology and training must allow the recipients to:

• Transmit and receive electronic prescription information; or
• Create, maintain, transmit or receive electronic health records.

The new rules do not cover every gift or discounted sale of technology and training. For example, the exception and safe harbor do not apply if the donor selects the recipient based on the recipient’s volume or value of referrals. Furthermore, transferred technology must meet interoperability standards established by HHS. Without compliance with these and other requirements of the new rules, health care providers may not be protected from penalties under the self-referral or anti-kickback laws.

Jill Steinberg
212.492.3305
steinberg.jill@arentfox.com