Stark and Anti-Kickback Exemptions for Donation of Interoperable EHR technology

In August 2006, the Department of Health and Human Services (HHS) published rules that provide an exception under the physician self-referral prohibition law (Stark), as well as safe harbor under the anti-kickback act (AKA), for the donation of interoperable EHR technology to physicians and other health care practitioners or entities. More information on Stark and anti-kickback regulations is available from the HHS website,which indicates that to qualify, EHR software is “deemed to be interoperable if a certifying body recognized by the Secretary has certified the software no more than 12 months prior to the date it is provided to the [physician/recipient].” CCHIT is an officially recognized certifying body. The following EHR products have been certified within the past 12 months and therefore qualify for the exemptions under the published rules:

company (product version)
date certified
Conceptual Mindworks, Inc.
(Sevocity, Version 5.0)
Pre-market, conditional certification
5/5/2008
HealthPort
(HealthPort EMR V9.0)
5/1/2008

Allscripts
(TouchWorks, V11.1)
4/30/2008
Cerner Corporation
(Cerner Millennium PowerChart/PowerWorks EMR, Version 2007)
4/24/2008
Eclipsys Corporation
(Sunrise Ambulatory, Version 4.5C SP5)
Pre-market, conditional certification
4/22/2008
STI Computer Services
(ChartMaker, Version 3.0.5)
4/22/2008
Wellogic and GBA Health Network Systems
(Wellogic Consult Version 3.10 Release 10 and GBA MEDfx Version 2.8)
3/26/2008
digiChart, Inc.
(digiChart OB-GYN Version 7.0)
3/20/2008
Misys Healthcare Systems
(Misys EMR, Version 9.10)
Pre-market, conditional certification
2/22/2008
Misys Healthcare Systems
(Misys MyWay, Version 2008)
Pre-market, conditional certification
2/22/2008
Nightingale Informatix Corporation
(Nightingale On-Demand, Version 8.2)
Pre-market, conditional certification
2/22/2008
CareData Solutions Corporation
(The CareData Solution, Version 2.7)
Pre-market, conditional certification
2/18/2008
MediNotes Corporation
(MediNotes e Version 5.2)
1/24/2008
Allscripts
(Healthmatics EHR Version 2007.1)
1/23/2008
Noteworthy Medical Systems
(NetPractice EHR 6.0)
1/17/2008
Sage
(Intergy EHR by Sage, Version V4)
1/17/2008
HIT Services Group
(Acumen EHR 5)
12/11/2007
Epic Systems Corporation
(EpicCare Ambulatory EMR Spring 2007)
11/30/2007
PracticeOne
(e-Medsys Electronic Health Record)
11/30/2007
MedAppz
(iSuite version 3.5)
11/1/2007
eCast Corporation
(eCast EMR 7.0)
9/21/2007
eClinicalWorks, LCC
(eClinicalWorks 7.6.15)
8/10/2007
Purkinje
(CareSeries EHR 2.0)
7/27/2007
e-MDs, Inc.
(e-MDs Solution Series 6.1.2)
7/18/2007
McKesson Provider Technologies
(Practice Partner 9.2.1)
7/17/2007
Community Computer Service
(MEDENT 17)
7/11/2007
NextGen Healthcare Information Systems, Inc.
(NextGen EMR 5.4.29)
6/25/2007
NextGen Healthcare Information Systems, Inc.
(NextGen EMR 5.5)
6/25/2007
Greenway Medical Technologies
(PrimeSuite 2007 R2)
6/22/2007
   

Pre-market, conditionally certified EHRs are new products that are fully certified once their operational use at a physician office site has been verified.

** Internally developed system

Vendors: Maintaining Qualification under the Stark and AKA Exemption Rules

The Certification Commission believes that the Stark and AKA exemption requirement for products to be certified within 12 months prior to donation was intended to ensure that donated products are up-to-date in supporting the latest interoperability standards. The Commission has also noted, however, that practical issues may make it difficult for vendors to maintain continuous compliance throughout a product life cycle. One such issue is CCHIT’s change in its certification cycle: while 2007 certification became available on May 1st of that year, 2008 certification will not be launched until July 1, 2008, making it impossible for some vendors to obtain a new certification within the 12 month window.

To provide a practical solution to these issues, the Certification Commission has updated and clarified its policies regarding product certification dates for purposes of the Stark and AKA exemptions. Vendors should take note of the following:

  • The date certification is first awarded to a product, after successful completion of all inspections, sets the initial certification date for purposes of the Stark/AKA 12-month requirement.
  • When a vendor notifies the Commission that a minor update has been made and simply attests that the product remains compliant with the original criteria, the new version number will be added to the Commission’s listing, but the certification date for the product for Stark/AKA purposes remains unchanged.
  • When a vendor notifies the Commission that a significant change has occurred, and the new version is submitted for retesting and recertification, a new certification date for the product will be set at the time such recertification is awarded. 
  • When a vendor applies for recertification of a product or certification of a new product, the Commission will automatically update the certification date of the vendor’s previous product version in order to maintain its Stark/AKA qualification status for up to 90 days during the time when the application and inspection of the updated version/new product is in process.

Important Information about CCHIT Certification

Each product listed on this page has achieved CCHIT Certified status and have a certification date within the last 12 months. CCHIT represents that the Certified products listed on our Web site have been inspected against our published Criteria, using our published Test Scripts, according to the methods and policies published in our Certification Handbook. CCHIT has not inspected, nor does it make any representations, about any other characteristics of these products or companies such as usability, financial viability or after sales service and support.

The Ambulatory EHR Criteria represent basic requirements that the Commission and its Workgroups believe are appropriate for many common ambulatory care settings. CCHIT acknowledges that these Criteria may not be suitable for settings such as behavioral health, emergency departments, or specialty practices and our current certification makes no representation for these. Purchasers should not interpret a lack of CCHIT Certification as being of significance for specialties and domains not yet addressed by CCHIT Criteria.