Archive for April, 2014

ACR Comments on ONC’s Proposed Rule to Establish Voluntary 2015 Edition EHR Certification Criteria

April 24, 2014 1 comment

On April 24, the American College of Radiology (ACR) submitted comments to the HHS Office of the National Coordinator for HIT (ONC) regarding the agency’s proposed rule to establish voluntary 2015 Edition EHR certification criteria. The 2015 Edition would be an optional alternative to the 2014 Edition criteria for the certification of products used by participants in the Medicare/Medicaid EHR Incentive Program (“meaningful use”). Additionally, the proposed rule included several questions intended to inform the ONC’s future 2017 Edition rulemaking.

The ONC’s two previous EHR certification criteria rulemakings took about 7 to 8 months between the publication dates of the proposed rules and final rules. While it is possible ONC could turn the 2015 Edition final rule around more quickly (perhaps even as early as August), it is unclear how the separate and conflicting 2017 Edition rulemaking will impact the timing.

Categories: EHR, meaningful use, Medicare

ACR-ASA-CAP Recommendations to CMS on Meaningful Use Hardship Exceptions and Other Program Improvements

April 16, 2014 1 comment

On April 15, the American College of Radiology (ACR), American Society of Anesthesiologists (ASA), and College of American Pathologists (CAP) submitted recommendations to the Centers for Medicare and Medicaid Services (CMS) regarding the Medicare EHR Incentive Program. The organizations, collectively representing over 100,000 physicians, had three requests:

  1. Continue the specialty code-based significant hardship exception for anesthesiology, pathology, and radiology for the maximum five years allowed by statute.
  2. Implement the ACR and Radiology Business Management Association’s November 2013 proposal for an optional administrative process by which eligible professionals located in unhelpful hospitals could obtain “hospital-based” status, and therefore ineligibility.
  3. Make improvements and add flexibility to the program’s participation requirements to enable more specialists to participate in a meaningful way.

The above recommendations could be incorporated by CMS into the Stage 3 Meaningful Use rulemaking without requiring additional legislation to expand the agency’s regulatory authority. CMS and the Office of the National Coordinator for HIT plan to publish proposed rules on Stage 3 MU and the “2017 Edition” EHR certification criteria around Fall 2014 with final rules promulgated in mid-2015.

Categories: EHR, meaningful use, Medicare

CMS Implements ACR Recommendation: Addresses Stage 2 Meaningful Use Compliance Barrier

April 8, 2014 Leave a comment

The Centers for Medicare and Medicaid Services (CMS) recently released new guidance to allow physicians without office visits to obtain an exclusion from the Stage 2 Meaningful Use (MU) “electronic notes” menu objective. The American College of Radiology has been advocating for this change since the September 2012 publication of the Stage 2 MU final rule.

Prior to the guidance, compliance with Stage 2 MU was effectively impossible for physicians without office visits. The reason was that office visits were used in the denominator for the electronic notes measure, yet CMS did not provide a corresponding exclusion for physicians with zero office visits during the reporting period. As most physicians without office visits would also tend to be excluded from 3-5 menu objectives in Stage 2 MU—and menu exclusions no longer reduce the total number of menu objectives participants must report (as of 2014)—those physicians would be required by default to “choose” the electronic notes menu objective.

The above circumstances created a perfect storm for failure… Zero denominators are not allowed for the MU objectives, so participants without office visits were either doomed to fail the electronic notes objective—and therefore fail MU altogether—or had to define their non-visit professional services as “office visits” to generate some kind of a denominator. Doing the latter also meant those participants could not leverage the “no office visits” exclusion for various other Stage 2 MU objectives, thereby making MU even more burdensome.

While it took time due to staff changes and other challenges, CMS should be applauded for taking the necessary steps to correct an administrative oversight that, from their perspective, impacted only a small minority of MU participants (i.e., those without office visits who made it to Stage 2). Moving forward, however, it would be better for all MU objectives to have qualitative, scope of practice-based exclusions so that nuances and seemingly minor oversights do not snowball into major compliance barriers.

Categories: EHR, meaningful use, Medicare

FDA, ONC, and FCC Release Report to Congress on a Risk-Based Approach to Regulating Health IT

April 3, 2014 Leave a comment

On April 3, the Food and Drug Administration (FDA), Federal Communications Commission (FCC), and HHS Office of the National Coordinator for HIT (ONC) released their highly anticipated report to Congress on a proposed strategy for a risk-based framework for regulating health information technology, including mobile medical applications. The report, which was mandated by the FDA Safety and Innovation Act (FDASIA) of 2012, has been in development since the FDASIA Working Group approved its final recommendations to the tri-agencies in late 2013.

The report categorizes health IT functionality into three buckets: administrative (scheduling, billing, inventory, etc), health management (most CDS, CPOE, electronic access to results, etc.), and higher-risk medical device functionality (CAD, bedside monitor alarms, radiation treatment software, etc). The focus of FDA regulation will continue to be on the third category. Private sector and ONC-coordinated quality/safety/standards conformity management activities will generally focus on the second category. FDA is seeking public comment on categorizing HIT that straddles the line between the second and third categories, such as certain CDS and EHR functions.

Moving forward, the tri-agencies will solicit public comment on the report and convene a three-day public meeting. The tri-agencies will also report periodically to the ONC HIT Policy Committee regarding implementation efforts.  Additionally, Memorandums of Understanding will need to be developed in the future when and where jurisdictions mesh.

ONC and OCR Release HIPAA Security Risk Assessment Tool

April 1, 2014 1 comment

The HHS Office of the National Coordinator for HIT (ONC) and Office for Civil Rights (OCR) released a tool for Windows 7 and iOS designed to to assist small-to-medium sized practices in performing a Security Risk Assessment (SRA) required under the Health Insurance Portability and Accountability Act (HIPAA) Security Rule. The Windows version of the SRA tool is available on ONC’s website, while the iOS version is available for free on Apple’s App Store.

The new SRA tool identifies problem areas where electronic protected health information (ePHI) could be compromised; however, it serves as more of an educational resource within the practice than a means of regulatory compliance. Individual professonials within a practice are meant to fill out a series of questions to determine risks and levels of security awareness.

ONC is requesting informal feedback from public stakeholders on the SRA tool. The informal comment period closes on June 2.

Categories: EHR, meaningful use, Medicare