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.
ACR-ASA-CAP Recommendations to CMS on Meaningful Use Hardship Exceptions and Other Program Improvements
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:
- Continue the specialty code-based significant hardship exception for anesthesiology, pathology, and radiology for the maximum five years allowed by statute.
- 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.
- 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.
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.
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.
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.
Radiologists often inquire about the significant hardship exception available to certain specialists as temporary reprieve from the payment adjustments for nonparticipation in the Medicare/Medicaid EHR Incentive Program (“Meaningful Use”). The most common question—is this automatically granted, or do I need to complete some sort of action?
As a quick background, one of the available exceptions is for physicians whose primary specialty codes in the Provider Enrollment, Chain and Ownership System (PECOS) are diagnostic radiology (30), nuclear medicine (36), or interventional radiology (94) (also anesthesiology and pathology). While the Centers for Medicare and Medicaid Services (CMS) suggested in public meetings that this particular option will be automatically granted, official written guidance from the agency lacked clarification about whether or not it will be fully and truly automatic (i.e., no further manual action required by the radiologist to obtain it).
That ambiguity has been addressed. Newly revised and enhanced guidance materials from CMS state:
Specialties – If you are classified in the Medicare Provider Enrollment, Chain and Ownership System (PECOS) as having one of the following 5 specialty codes as your primary area of practice you DO NOT need to submit this form. You will be granted a Hardship Exception and are automatically exempt from the 2015 payment adjustment based on the data in PECOS.
- Diagnostic Radiology (30)
- Nuclear Medicine (36)
- Interventional Radiology (94)
- Pathology (22)
Therefore, if radiologists’ primary specialty code in PECOS is 30, 36, or 94 prior to the middle of this year, they will be automatically granted the exception for CY 2015 based on their PECOS data without having to fill out additional forms. Anyone planning to take advantage of this option should double-check their PECOS data before the month of July 2014 to make sure their primary specialty code is correct.
For information about other ways to avoid Meaningful Use payment adjustments, please read this article.
On March 11, the HIT Policy Committee (HITPC) of the Office of the National Coordinator for HIT (ONC) approved the Meaningful Use (MU) Workgroup’s recommendations for Stage 3. Several members of the HITPC shared concerns about aspects of the recommendations and whether or not the suggested approach would be the best approach. One member questioned the representativeness of the MU Workgroup and expressed the need for more practitioners and vendors in that advisory body.
Ultimately, the workgroup’s recommendations were approved as expected and will soon move up to the ONC and the Centers for Medicare and Medicaid Services (CMS) as those agencies begin drafting the future Notices of Proposed Rulemaking for Stage 3 MU and the 2017 Edition EHR Certification Criteria. The ONC and CMS staff are free to use, or not use, the recommendations however they wish.
The HITPC-approved recommendation for the Stage 3 iteration of the “clinical decision support” objective includes imaging (and lab-test) order appropriateness alongside a handful other priority areas for CDS interventions. The HITPC-approved recommendations do not offer a Stage 3 iteration of the Stage 2 objective for “imaging results access.” Likewise, the recommendations do not include sharing imaging data as part of the suggested Stage 3 “patient view/download/transmit” (patient portal) objective. Unfortunately, the recommendations do not include any mention of increased flexibility, alternative compliance pathways, or major regulatory framework changes to reduce the burden of MU compliance for specialists. As always, the American College of Radiology will work to educate the regulatory agencies.
At the same HITPC meeting, CMS staff announced a new guidance that will allow prior MU participants and new participants to obtain a significant hardship exception for the inability to implement 2014 Edition certified products in time. The announcement was important for any physicians unable to take advantage of the other available significant hardship exception options. Most radiologists are already covered by the other options.
ONC HITSC Standards Task Force Begins to Explore Technical Feasibility of HITPC Meaningful Use Workgroup’s Recommendations
The newly formed Standards Task Force of the HIT Standards Committee (HITSC) held its first meeting on March 7 to gear up for future discussions on the technical feasibility of the HIT Policy Committee (HITPC) Meaningful Use (MU) Workgroup’s Stage 3 recommendations. The task force will examine the Stage 3 MU advice from a “standards maturity” (immature, emerging, approved, or adopted) and “development effort” (low, med, or high) point of view.
The full HITPC is expected to approve the MU Workgroup’s recommendations at its monthly meeting on March 11. The HITSC’s Standards Task Force will then convene discussions on March 17 and March 24 to organize and refine opinions on technical feasibility. The finalized findings will be presented to the full HITSC on March 26.
After reviewing the HITPC’s Stage 3 MU recommendations, the task force will shift its focus over to proposals in the Office of the National Coordinator for HIT’s (ONC) 2015 Edition EHR Certification Criteria proposed rule.
Meaningful Use Workgroup Prepares to Present Stage 3 MU Recommendations to Full HIT Policy Committee for Approval
The HIT Policy Committee (HITPC) Meaningful Use (MU) Workgroup held its final public discussion on March 4 in preparation for next week’s full HITPC meeting when the workgroup’s Stage 3 MU recommendations will be presented and likely approved. Following HITPC approval, the recommendations will go to the HHS Office of the National Coordinator for HIT (ONC) and Centers for Medicare and Medicaid Services (CMS) to inform the future Stage 3 MU and 2017 Edition EHR Certification Criteria rulemakings.
Importantly, CMS and ONC staff are free to use or not use the HITPC recommendations however they wish as they work on proposed rules over the next several months. CMS and ONC hope to publish the Notices of Proposed Rulemaking on Stage 3 MU and the 2017 Edition around Fall 2014 for public comment, with final rules promulgated around mid-2015.
In terms of imaging-related subtopics, the MU Workgroup will likely recommend discontinuing the “imaging results access” objective in Stage 3 MU. The workgroup’s expressed goal for this change was to reduce participants’ reporting burden (i.e., the total number of MU objectives recommended for Stage 3 Meaningful EHR Users). Also, the MU Workgroup is not explicitly recommending the inclusion of imaging data in the “patient view, download, transmit” (or “patient portal”) objective despite the recent work of the HIT Standards Committee’s Clinical Operations Workgroup. Finally, the MU Workgroup continues to recommend that one of the main priority areas for CDS rules/interventions be radiology and lab-test appropriateness.
ONC’s Proposed Rule on the Optional 2015 Edition EHR Certification Criteria Released for Public Comment
Earlier this evening, the Office of the National Coordinator for HIT (ONC) made available its Notice of Proposed Rulemaking (NPRM, or proposed rule) to establish the optional 2015 Edition EHR certification criteria for HIT products used in the Medicare/Medicaid EHR Incentive Program. The NPRM is currently on the Federal Register‘s public inspection desk and is scheduled to be formally published on February 26 for a sixty-day public comment period.
It is somewhat of an unorthodox NPRM in that portions of it deal with proposals for the 2015 Edition regulations, while the rest is comprised of RFI-style questions for use in informing the 2017 Edition rulemaking. ONC noted in the preamble that they will not be addressing public comments submitted on 2017 Edition in the future 2015 Edition final rule. However, one of the challenges of incorporating 2017 Edition-specific questions in this NPRM is that those items are then technically viable for finalization in the 2015 Edition final rule per the Administrative Procedure Act.
The ACR Government Relations team is currently reviewing the NPRM and will work with ACR’s IT and Informatics Committee leaders on developing comments in the near future. Some of the proposals of interest for the 2015 Edition include:
- Doing away with the “Complete EHR” certification status to emphasize modular certification.
- Maintaining the exact same “imaging results accessibility” certification criterion as the 2014 Edition iteration.
- Separating the three order types (meds, labs, and radiology) into separate CPOE criteria; something ACR has advocated for years to enable enhanced radiology CPOE software to obtain modular certification.
- Requesting comments on (but not actually proposing for the 2015 Edition) the following three questions as they relate to imaging data and the “patient view/download/transmit” criterion: 1) whether images for patients need to be of diagnostic quality; 2) whether they should be viewable and downloadable; and 3) whether cloud-based technology could allow for a link to the image to be made accessible.
- Overhauling the CDS criterion to align with the Health eDecisions initiative.
- Recording user “ignore” responses to drug-drug/drug-allergy interaction alerts during medication orders.
If you would like to submit comments to ACR for consideration and potential use in ACR’s future comments on this NPRM, please contact me at firstname.lastname@example.org / 202-223-1670.