EHR Vendor Loses Meaningful Use Certification

HHS announced on Thursday that two EHRs have had their Meaningful Use certification revoked.  EHRMagic-Ambulatory and EHRMagic-Inpatient, which are developed by EHRMagic, Inc., were previously certified for the Medicare and Medicaid EHR Incentive Programs.  It is the first time that a certified EHR has had its certification status revoked. 

ONC and InfoGard Laboratories, an ONC authorized certification body for Meaningful Use, both were notified that the EHRs did not provide required functions and shouldn't have passed certification.  After retesting, the EHRs failed. 

ONC has made it clear that certification is an ongoing process. Dr. Mostashari stated,  

We and our certification bodies take complaints and our follow-up seriously.  By revoking the certification of these EHR products, we are making sure that certified EHR products meet the requirements to protect patients and providers."

Eligible professionals and hospitals who purchased the decertified EHRs will have no choice but to implement an alternative EHR in order to continue participating in Meaningful Use. EHRMagic customers now are in a difficult situation, with significant costs, downtime and retraining to transition to a new EHR as well as loss in incentive payments they would have otherwise been potentially eligible for.

iHealthBeat.org reports that no one has attested to Meaningful Use using the EHRMagic products yet, according to Peter Ashkenaz, an ONC spokesperson. These means that EHRMagic customers will at least not be faced with potential recoupment of payments.  It remains unclear what liability EHRMagic may have to its customers for failing to retain certification for its EHR products.    

 

Proposed Rules Extend EHR Donation Sunsets for Stark and Anti-Kickback

Earlier this month, CMS and OIG proposed amendments to and extension of the temporary Stark exception and Anti-kickback safe harbor for electronic health record (EHR) donations to physicians. The Proposed EHR Rules would extend the deadlines for EHR donations which are set to expire December 31, 2013.

The Proposed EHR Rules come at a perfect time, when many organizations are adopting EHRs for purposes of participating in the Medicare and Medicaid EHR Incentive Programs ("Meaningful Use"). Although the OIG Proposed Rule would extend EHR donations until at least December of 2016, the CMS Proposed Rule contemplates extending EHR donations through December of 2021 to align with the end of Medicaid Meaningful Use. 

The Anti-kickback Statute prohibits referrals for federal health care business.  Certain "safe harbors" provide assurances that certain conduct will not violate the Anti-kickback Statute.  One of these safe harbors, the EHR safe harbor, permitted certain EHR donations of interoperable EHRs and other technology and services. 

The OIG Proposed Rule would:

  • Amend how interoperable EHRs are treated, permitting also certified EHR technology adopted for purposes of Meaningful Use;
  • Remove the e-prescribing capability requirement; and
  • Extend the sunset date of the safe harbor to coincide with the end of Medicare Meaningful Use payments and the last year in which one can begin participating in Medicaid Meaningful Use.

OIG also requests public comment on additional amendments, such as limiting the scope of protected donors to only hospitals group practices, PDP sponsors and MA organizations.  It also requests comment on modifying or adding conditions to prevent risk of misuse of the EHR safe harbor and limit the risks of data and referral lock-in. 

The Stark Law prohibits physician self-referrals for designated health services payable by Medicare.  The Stark Law allows for certain exceptions which an arrangement must fit into. Almost identical to the EHR safe harbor under the Anti-kickback Statute, the EHR exception also allowed for donations of interoperable EHRs. 

Like the OIG Proposed Rule, the CMS Proposed Rule would likewise amend what interoperable EHRs are permitted to include those adopted for Meaningful Use, remove the e-prescribing capability requirement, and extend the sunset date of the safe harbor. Both CMS and OIG acknowledged that e-prescribing is adequately provided for by Meaningful Use and the Medicare E-Prescribing Incentive Program.  However, while CMS proposes to extend the sunset date to December 2016, it acknowledges that it is contemplating extending EHR donations through December 2021. 

Comments to the EHR Proposed Rules are due no later than 5pm EST on June 10, 2013.

 

Joy Pritts, Special Guest Speaker at Seton Hall Law - HIPAA, HITECH and Our Cyber World

This coming Friday, April 19th, Seton Hall Law in collaboration with the Bergen County Prosecutor’s Office is offering a fantastic event called: “HIPAA, HITECH & Beyond: Protecting Healthcare Data in Our Cyber World”, which promises to examine current issues, enforcement trends, and regulations relevant to healthcare with data privacy experts who counsel hospitals, providers, and other healthcare facilities. Joy Pritts, Chief Privacy Officer for ONC will be a Special Guest Speaker, and I am honored to also be among the distinguished list of Faculty for this event. If you can, I hope that you might consider joining me this Friday at Seton Hall.  To register, visit: htttp//www.law.shu.edu/healthcaredata.com.  (Up to 6.0 hours NY/NJ CLE available)

 

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