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
MDTablet
(mdTablet 4.0.0)
7/2/2009
CentriHealth, Inc.
Pending e-Prescribing certification
(CentriHealth Individual Health Record (IHR) Release 2009.1.17)
7/1/2009
MedConnect
(MedConnect EHR 1.0)
6/30/2009
InteGreat Concepts, Inc.
Pre-market, conditional certification
(InteGreat EHR Release 6.3 )
6/25/2009
Complete Medical Solutions, LLC
Pre-market, conditional certification
(MyWinmed EMR 1.2)
6/25/2009
Prime Clinical Systems
Pre-Market, Conditional certification
Pending e-Prescribing certification
(Patient Chart Manager 5.5)
6/24/2009
NexTech Systems Inc.
(NexTech Practice 2010 9.3)
6/24/2009
Secure Infosys, LLC
Pre-market, conditional certification
(MyEMR 2.0)
6/24/2009
AllMeds, Inc.
Pre-market, conditional certification
(AllMeds EMR Version 8)
6/17/2009
Noteworthy Medical Systems, Inc.
Pre-market, conditional certification
(NetPracticeEHRweb 7.0)
6/16/2009
iSALUS Healthcare
Pending e-Prescribing certification
(OfficeEMR 2009)
6/15/2009
GE Healthcare
Pre-market, conditional certification
(Centricity Electronic Medical Record 9.2)
6/11/2009
Marshfield Clinic
Pending e-Prescribing certification
(CattailsMD Version 5.9)
6/4/2009
iMedica
Pre-market, conditional certification
(Patient Relationship Manager 2010)
6/4/2009
athenahealth, Inc
(athenaClinicals 9.15.1)
6/2/2009
Criterions, LLC
(Criterions 1.0.0)
5/29/2009
AmazingCharts.com, Inc.
Pre-market, conditional certification
(Amazing Charts 5)
5/29/2009
Conceptual MindWorks, Inc.
Pre-market, conditional certification
(Sevocity Version 08)
5/26/2009
Agastha, Inc.
Pending e-Prescribing certification
(Agastha PM & EMR 1.2)
5/21/2009
Total OutSource, Inc.
Pre-market, conditional certification
(ezEMRxPrivate 7.00)
5/21/2009
LSS Data Systems (Lake Superior Software)
Pending e-Prescribing certification
(Medical and Practice Management (MPM) Suite Client/Server 5.6)
5/21/2009
Axolotl Corporation
Pre-market, conditional certification
(Elysium 9)
5/19/2009
Medflow, Inc.
Pre-market, conditional certification
(Medflow EMR Version 7.1)
5/19/2009
San Diego Hospitalist Physician Corp.
Pre-market, conditional certification
(Xpert EMR 2.0)
5/14/2009
Glenwood Systems LLC
(GlaceEMR 3.0)
5/11/2009
MTBC (Medical Transcription Billing Corporation)
(MTBC EMR 4.0)
5/11/2009
Health Systems Technology, Inc.
(MedPointe 9)
5/7/2009
Meditab Software, Inc.
(Intelligent Medical Software (IMS) 12)
5/7/2009
SuiteMed
(SuiteMed Intelligent Medical Software 12)
5/7/2009
CureMD Corporation
Pending e-Prescribing certification
(CureMD EHR 10)
4/29/2009
Cerner Corporation
(Cerner Millennium Powerchart/PowerWorks EMR 2007.19)
4/22/2009
Abraxas Medical Solutions
Pre-Market, Conditional certification
(Abraxas EMR 4.1)
4/17/2009
OIS
Pre-Market, Conditional certification
(OIS EMR 4.1)
4/17/2009
PracticeOne
Pre-Market, Conditional certification
(e-Medsys - Electronic Health Record (EHR) 5.2)
4/17/2009
Connexin Software, Inc.
Pending e-Prescribing certification
(Office Practicum 8.1)
4/10/2009
gloStream, Inc.
Pending e-Prescribing certification
(gloEMR 5.0)
4/10/2009
Sage
(Sage Intergy EHR v5.5)
4/9/2009
Integritas, Inc.
Pre-Market, Conditional certification
Pending e-Prescribing certification
(STIX EHR Release 9.1)
4/9/2009
Noteworthy Medical Systems, Inc.
Pre-Market, Conditional certification
(NetPractice 7.0)
4/2/2009
Allscripts-Misys Healthcare Solutions, Inc.
(Enterprise 11.1.6)
3/26/2009
STI Computer Services, Inc.
(ChartMaker® Clinical, Version 3.2)
3/23/2009
Allen Systems Group, Inc.
Pending e-Prescribing certification
(ASG-Medappz iSuite, Version 4)
3/20/2009
MedAppz, LLC
Pending e-Prescribing certification
(iSuite, Version 4)
3/20/2009
Intuitive Medical Software
Pre-market, conditional certification
(UroChart EHR v3.0)
3/13/2009
Advanced Data Systems Corporation
(MedicsDocAssistant, Version 4.0.1)
2/9/2009
Silk Information Systems Inc.
(SILK, Version 4.2)
2/6/2009
e-MDs
(e-MDs Solution Series, Version 6.3)
2/3/2009
ABEL Medical Software Inc.
Pending e-Prescribing certification
(ABELMed EHR-EMR/PM v9)
1/28/2009
Eclipsys Practice Solutions
Pending e-Prescribing certificationspan
(Eclipsys PeakPractice 1093)
1/22/2009
Allscripts-Misys Healthcare Solutions, Inc.
(Professional EHR, Version 8.2)
1/8/2009
Henry Schein Medical Systems
(MicroMD EMR 7.0)
12/19/2008
American Medical Software
(Electronic Patient Charts, Version 20)
11/12/2008
Gateway Electronic Medical Management Systems, Inc.
(GEMMS ONE G1.07)
10/28/2008
MedInformatix, Inc.
(MedInformatix, Version 7.0)
10/28/2008
Assistmed, Inc.
(EZChart 1.2.0.0)
9/30/2008
Community Computer Service Inc.
(MEDENT 18.1)
9/30/2008
eClinicalWorks
(eClinicalWorks 8.0)
9/30/2008
Epic Systems Corporation
(EpicCare Ambulatory EMR Spring 2008)
9/30/2008
Greenway Medical Technologies, Inc.
(PrimeSuite 2008)
9/30/2008
McKesson Provider Technologies
(Practice Partner 9.3)
9/30/2008
MedLink International, Inc
(MedLink TotalOffice 3.1)
9/30/2008
MedPlexus, Inc.
(MedPlexus EHR 9.2.0.0)
9/30/2008
NextGen Healthcare Information Systems, Inc.
(NextGen EMR 5.5.27)
9/30/2008
Pulse Systems
(Pulse Patient Relationship Management 4.1)
9/30/2008
VIP Medicine LLC
(SmartClinic 16)
9/30/2008
Indian Health Service
Pre-market, conditional certification
(Resource and Patient Management System, Version 2008)
6/30/2008
Ochsner Clinic Foundation
Pre-market, conditional certification
(Ochsner Clinical Workstation, Version 1.9.8**)
6/30/2008
Eclipsys Corporation
Pre-market, conditional certification
(Sunrise Ambulatory Care 5.0 with Sunrise Interface Sub System 5.0, Eclipsys Auditing Services 1.0 XA and Eclipsys Security Services 1.0 XA)
6/27/2008
LSS Data Systems
(Medical and Practice Management (MPM) Suite, Version: Client Server 5.54)
6/27/2008
LSS Data Systems
(Medical and Practice Management (MPM) Suite, Version: Client Server 5.55)
6/27/2008
Intivia
(InSync, Version 4.1)
6/26/2008
Doctations, Inc.
(Doctations, Version v1.0106062008)
6/24/2008
GE Healthcare
(Centricity EMR, Version 9.0)
6/24/2008
GE Healthcare
Pre-market, conditional certification
(Centricity Enterprise, Version 6.7)
6/24/2008
   

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.