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Archive for December, 2013

CMS and HHS OIG Publish Final Rules on EHR Exception/Safe Harbor from Self-Referral/Anti-Kickback Requirements

December 27, 2013 1 comment

The final rules from the Centers for Medicare and Medicaid Services (CMS) and HHS Office of Inspector General (OIG) regarding the renewal and revision of the EHR exception/safe harbor from self-referral/anti-kickback requirements were published in today’s Federal Register.

The American College of Radiology (ACR) commented on the proposed rules in June 2013 and is currently reviewing the final versions. As a quick overview:

  • The EHR exception and safe harbor were renewed as expected, this time until 2021.
  • Laboratories will not be allowed to donate technology.
  • “Interoperability” will continue to be deemed via certification; however…
  • There are more explicit requirements to support interfacing donated products with competitors’ systems and services.  Some examples:
    • The ability of donated EHR/eRx technology to interface with other types of HIT products (such as RIS) cannot be limited in any way. Before, this requirement was often interpreted as being specific to EHR-to-EHR product connectivity.
    • Donors are not allowed to take any action whatsoever or make any kind of agreement with recipients limiting the donated technology’s ability to interface with competitors.  Any action could be used as evidence of abuse.
    • Donors can no longer charge high fees to interface donated EHRs with competitors’ systems and services.  CMS/OIG will review potential fee abuses on a case-by-case basis.
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Categories: EHR, Medicare

Clinical Operations Workgroup’s Imaging Recommendations Presented to Full HIT Standards Committee

December 18, 2013 1 comment

The HIT Standards Committee (HITSC) Clinical Operations Workgroup presented its latest recommendations regarding standards for image sharing at the monthly HITSC meeting on December 18. Aspects of the workgroup’s recommendations will be included in the HIT Policy Committee’s and HITSC’s advice to the HHS Office of the National Coordinator for HIT (ONC) regarding future regulatory updates to meaningful use (MU) and the EHR certification criteria.

The workgroup identified imaging data standards for each of four different scenarios, or “tiers” of use:

  • Exchange of text-based reports
  • Exchange of non-radiology/cardiology medical images (such as pictures used in dermatology, etc.)
  • Exchange of full radiology/cardiology imaging studies
  • Exchange of key images from radiological/cardiology imaging studies

The slide displaying the workgroup’s current recommendations for each tier is available here.

The recommendations are the product of several months of workgroup deliberations and presentations from a variety of players in the imaging standards arena, such as the Radiological Society of North America, radiology IT industry representatives, NIH, and others. Dr. Keith Dreyer, Chair of ACR’s IT and Informatics Committee, presented to the workgroup back in June 2013.

Categories: EHR, meaningful use, Medicare

CMS and ONC Announcement Regarding a Stage 2 MU Extension: What Does It Mean?

December 11, 2013 2 comments

Late last week, the Centers for Medicare and Medicaid Services (CMS) and the HHS Office of the National Coordinator for HIT (ONC) announced plans to extend Meaningful Use (MU) Stage 2, delay the upcoming Stage 3 and 2017 Edition certification criteria rulemakings, and implement a 2015 Edition of EHR certification criteria.

The most noteworthy piece of the announcement was that CMS will delay the “Stage 3 MU” rulemaking by several months.  The agency is now targeting a fall 2014 release of the proposed rule and a mid-2015 release of the final rule. ONC plans to release the “2017 Edition EHR certification criteria” proposed and final rules on the same timeline.

Additionally, ONC will conduct an extra, off-cycle rulemaking to establish so-called 2015 Edition EHR certification criteria. They plan to use that rulemaking to fix problems EHR developers might be having with the 2014 Edition requirements, as well as modify the way standards and implementation specifications are referenced in ONC’s regulations. The 2015 Edition will apparently be an optional alternative of sorts to the 2014 Edition.

The Stage 2 “extension” piece of the announcement will be a third year for participants who entered Stage 2 in 2014 (i.e., those physicians and hospitals who began MU in 2011 or 2012).  This is akin to the Stage 1 extension that 2011 participants were able to receive for 2013.  As described, the plan does not appear to delay the beginning of Stage 2 for those participants who are moving up next year.  It also does not seem to delay the mandatory implementation of 2014 Edition certified products in 2014.  Delays of that nature would require a rulemaking to modify the existing regulations; a process that would take considerably more time than what we have left.

Categories: EHR, meaningful use, Medicare

ACR and RBMA Request Long-Term Reprieve from Meaningful Use Penalties for Certain Physicians Located in Unhelpful Hospitals

December 2, 2013 1 comment

Prior to the holidays, the American College of Radiology (ACR) and Radiology Business Management Association (RBMA) sent a letter to the Centers for Medicare and Medicaid Services (CMS) requesting the establishment of an alternative process by which certain hospital-located physicians could optionally become ineligible for the EHR Incentive Program (“meaningful use” or MU) and its associated penalties.

While many ACR members are already temporarily protected from MU penalties for up to 5 years max, this request would provide long-term reprieve for a specific subset of physicians who have the misfortune of being located in hospitals that are not adequately enabling participation in the program.

Access the details of the ACR and RBMA request here.

Categories: EHR, meaningful use, Medicare