HHS Proposes Additional Safe Harbors and Exceptions to Promote the Donation of E-Prescribing and E-Health Records Technology

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In an effort to accelerate the widespread use of e-prescribing and e-health records technologies, the Department of Health and Human Services (“HHS”) proposed this month new exceptions to the Federal Stark law and new anti-kickback statute safe harbors.  The proposed exceptions and safe harbors would permit hospitals and other health care organizations to donate certain technologies to specified recipients in order to promote the exchange of e-prescribing information and e-health records. 

The following chart lays out schematically the overall structure of the proposed new exceptions and safe harbors.  Note that HHS has proposed two safe harbors and exceptions to promote the donation of e-health records technology.  HHS intends to adopt certification criteria for the interoperability of e-health records technology.  Interoperable e-health records technology allows patient information to be portable and to move with consumers from one point of care to another.  HHS has proposed a narrow exception and safe harbor that would apply to donations of e-health records technology made before HHS adopts interoperability criteria, and a broader exception and safe harbor that would apply to donations made after such criteria are adopted.  Note also that while HHS published the text of all of the proposed Stark exceptions and the text of the e-prescribing anti-kickback safe harbor, it has not published the text of the proposed e-health records safe harbors.  HHS needs to collect more information before it does so and thus, has merely alerted the public of its intention to publish proposed safe harbors in the future.  As a result, the information provided in the chart below is subject to change. 


 

Exceptions/Safe Harbors

 

E-Prescribing Exception/Safe Harbor

Pre-Interoperability Health Records

Post-Interoperability Health Records

Covered Technology

Items and services necessary and used solely to transmit and receive e-prescription drug information.  Includes hardware, software, internet connectivity, and training and support services.  

Software used solely for transmission, receipt or maintenance of e-health records.  Software must include an e-prescribing component.  Includes directly related training services. 

Certified health records software.  Software must include an e-prescribing component.  Software may include billing and scheduling software, provided that core function of software is e-health records.  Includes directly related training services. 

Required Technology Standards

Donated technology must comply with foundation standards for e-prescribing adopted by HHS.

E-prescribing component must comply with foundation standards for e-prescribing adopted by HHS.

Donated technology must comply with the product certification criteria adopted by HHS.  E-prescribing component must comply with foundation standards for e-prescribing adopted by HHS, to the extent those standards are not fully incorporated into product certification criteria.  

Permissible Donors

Hospitals (to members of their medical staff), group practices (to physician members), prescription drug plan sponsors and Medicare Advantage organizations (to network pharmacists and pharmacies, and to prescribing health care professionals).

Hospitals (to members of their medical staff), group practices (to physician members), prescription drug plan sponsors, and Medicare Advantage organizations.

Hospitals (to members of their medical staff), group practices (to physician members), prescription drug plan sponsors, and Medicare Advantage organizations.

Selection of Recipients

Donors may not take into account volume or value of referrals from recipient, or any other business between the parties.

Donors may not take into account volume or value of referrals from recipient, or any other business between the parties.

Donors may use criteria to select recipients that are not directly related to volume or value of referrals or any other business generated between the parties.

Value of Protected Technology

No specific dollar amount proposed as a cap on value of protected technology that may be donated. 

No specific dollar amount proposed as a cap on value of protected items and services that may be donated. 

No specific dollar amount proposed as a cap on value of protected items and services that may be donated.  However, cap on post-interoperability donations expected to exceed cap on pre-interoperability donations. 

If you have any questions or would like more information regarding the proposed exceptions and safe harbors described in this article, please contact David Stephan at 615.252.2355 or another member of the Boult Cummings Health Care Team.