Government Softens Regulations to Encourage Physician Adoption of Health Information Technology
Physicians can now accept donated technology and services relating to electronic health records (EHR) and electronic prescribing (e-prescribing) under exceptions and safe harbors to the physician self-referral (Stark) law and anti-kickback statute.
The final rules—published by the Centers for Medicare and Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG)—went into effect on Oct. 10, 2006. The rules were designed to encourage physicians to adopt EHR technology and promote the government’s ultimate goal of achieving fully interoperable EHRs for all patients.
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“Interoperable” means that the EHR software is able to:
- Communicate and exchange data accurately, effectively, securely and consistently with different information technology systems, software applications and networks, in various settings; and,
- Exchange data such that the clinical or operational purpose and meaning of the data are preserved and unaltered.
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"By removing barriers, these regulation changes will help physicians get these systems in place and working for patients faster," stated HHS Secretary Mike Leavitt in a
news release announcing the final regulations.
CMS and OIG used the same or similar criteria for the EHR and e-prescribing exceptions and safe harbors to establish the conditions under which:
- Entities furnishing designated health services may donate to physicians and certain other recipients interoperable EHR software, information technology, and training services.
- Hospitals and certain other entities may provide physicians and certain other recipients with hardware, software, or information technology and training services necessary and used solely for e-prescribing.
Quick facts on EHR/e-prescribing exceptions and safe harbors
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The scope of donors and recipients |
| EHR |
e-prescribing |
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Under the EHR exception, "any entity that furnishes designated health services to any physician" may qualify as a protected donor, and "any physician" may qualify as a protected recipient.
Under the EHR safe harbor, "any individual and entity that provides covered services and submits claims or requests for payment—either directly or through reassignment—to any federal health care program, and health plans" may qualify as a protected donor/recipient. |
Under the e-prescribing exception and safe harbor, donors and recipients are limited to:
- Hospitals donating to members of their medical staffs;
- Group practices donating to physician members; and,
- Prescription drug plan sponsors and Medicare Advantage organizations donating to prescribing physicians.
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Covered technology and services |
| EHR |
e-prescribing |
The EHR exception/safe harbor:
- Covers any software, information technology and training services that are "necessary and used predominately to create, maintain, transmit, or receive EHR;" it does not cover the donation of hardware.
- Requires that donated EHR software also contain an e-prescribing component.
Examples of EHR technology and services that may qualify for protection include:
- Interface and translation software
- Licenses for software
- Connectivity services (i.e., broadband and wireless)
- Maintenance and other support services directly related to EHR
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The e-prescribing exception/safe harbor:
- Covers hardware, software, information technology, and training services that are "necessary and used solely to transmit and receive electronic prescription information."
- Mandates that donated technology cannot be technically or functionally equivalent to technology that the recipient-physician already possesses and cannot be used for a purpose other than e-prescribing.
- Requires that donated items and services are provided as part of, or are used to access, an electronic prescription drug program that meets applicable standards under Medicare Part D at the time the items and services are provided.
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Other conditions
Arrangements for either the donation of EHR technology or e-prescribing technology must be set forth in a written agreement that specifies the items and services to be provided and the donor’s cost, and covers all of the items and services the donor will provide.
Among other conditions, additional requirements for donated EHR technology include:
- Interoperability requirement—All donated EHR technology must be interoperable at the time of the donation (see definition in sidebar, above). Any EHR technology that has been certified as interoperable by the Certification Commission for Health Care Information Technology (CCHIT) meets the government’s interoperability requirement.
- Cost-sharing requirement—To reduce the potential for abusive arrangements, recipients of donated EHR systems must pay 15 percent of the donor's cost for the technology.
- Sunset—In addition, consistent with the President’s goal of adoption of EHR technology by 2014, the protections for donated EHR technology and services will sunset on Dec. 31, 2013.
Links to additional information
For more details about the exceptions and safe harbors, see the following:
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Last Updated: 10/11/2007