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Overview

On Aug. 8, 2006, the Centers for Medicare & Medicaid Services (CMS) published a final rule to create new exceptions to the Stark law for nonmonetary remuneration provided in connection with electronic prescribing (e-prescribing) and electronic health records (EHRs). The two new exceptions took effect effective Oct. 10, 2006.
 
The exception addressing e-prescribing was mandated by provisions of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), which directed government officials to create a Stark law exception to protect certain arrangements involving the provision of software, hardware, services and related items of value used solely to receive and transmit electronic prescription drug information. The new exception for EHRs was published as part of the secretary’s prerogative to create exceptions for the Stark law.
 
The two rules are part of a broader effort by federal officials to encourage the adoption of interoperable EHRs and related technology to improve health care quality and efficiency. In publishing the rules, CMS noted that the exceptions differ from other Stark law exceptions because they are designed, as a result of a congressional mandate, to encourage adoption and use of new technology. Thus, while most exceptions to the Stark law focus on immunizing activities and relationships between designated health services (DHS) entities and their referral sources, the new exceptions are intended to promote business-technology relationships to spur health care delivery system changes.
 
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published similar  “safe harbor” provisions under the federal anti-kickback statute on the same date.

eHealth and e-prescribing exception content areas:
Comparison to other Stark exceptions Subscriber only graphic
Technology covered Subscriber only graphic
Standards and interoperability Subscriber only graphic
Donors and recipients Subscriber only graphic
Selection criteria Subscriber only graphic
Limits on value and cost-sharing obligations Subscriber only graphic
Duration of exceptions and sunset provisions Subscriber only graphic
Community-wide health information systems (42 CFR § 411.357(u)) Subscriber only graphic
Other requirements Subscriber only graphic

 
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