Stark Safe Harbor: Bluegate’s Introduction to New Regulations
On August 8, 2006, the United States Department of Health and Human Services (“HHS”) published new regulations which create exceptions and safe harbors to the Federal Stark Law and the Federal Anti-Kickback Statute. The new regulations establish a compliant framework under which donors can provide recipients with electronic prescribing technology and with electronic health records (“EHR”) technology.
The regulations permit Hospitals and other providers to assist Physicians and other recipients in making the necessary investment to more quickly adopt electronic prescribing and health records technology, furthering the government’s goal of improving patient safety, quality of care, and efficiency.
Who may donate goods and services?
For E-Prescribing
- Hospitals to their medical staffs - Group practices to their members - PDP sponsors and Medicare Advantage entities to their prescribing professionals.
For EHR
- Entities that provide Healthcare services may donate to persons or entities engaged in the delivery of Healthcare. - Hospitals to medical staff - Clinical reference labs to their Physician clients
What standards apply to donated technology?
- For E-Prescribing, whatever E-Prescribing standards are adopted by HHS at the time the donation is made. - For EHR, software must be interoperable, defined as “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 clinical or operational purposes and meaning of the data are preserved and unaltered.”
Is there a limit on the value of technology that can be donated?
- For E-prescribing there is no limit. - For EHR, the recipient must pay for 15% of the donor’s cost of donated technology and the donor cannot finance the recipient’s share of the cost.
What good and services may be donated?
For E-Prescribing
- Hardware, software, internet connectivity, training and support services necessary and used solely for E-Prescribing.
For EHR
- Software (which must have an E-Prescribing component), necessary and used predominantly to create, maintain, transmit or receive EHR - Connectivity - Interface building - Secure messaging from Physicians to patients - “Practice Management” including, billing and scheduling - Implementation, training services and help desk support services - Note: Hardware is prohibited to donate for EHR; allowed for E-Prescribing.
What other rules apply?
- Donations cannot be based on referrals or other actual or potential business generated by the recipient. - The agreement must be committed to a written signed document consisting of several discrete elements. - The donor cannot donate items if the recipient already possesses the technological equivalent. - These and other additional requirements are covered in greater detail in the more detailed summary attached.
When are the regulations effective?
October 10, 2006.
When do they expire?
- For E-Prescribing technology there is no expiration date on the donation. - EHR technology cannot be donated after December 31, 2013.
Bluegate assists health systems with business strategy, application strategies and ROI models to support this Stark Safe Harbor regulation. Bluegate’s Medical Grade Network® provides an IT infrastructure for Physician offices (e.g. help desk, application support, hosting, implementation, training, connectivity, etc.).
For more information please contact our office at stark@bluegate.com or call (713) 686-1100.
