Several American College of Radiology members have inquired about the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for HIT (ONC) May 23, 2014 proposed rule to allow continued use of 2011 Edition certified EHR technology to comply with the Medicare EHR Incentive Program in calendar year (CY) 2014. The program’s regulations currently require eligible professionals to use 2014 Edition certified products in CY 2014.
The ONC’s 2014 Edition EHR certification criteria regulations for HIT products were published in September 2012. A few months later, vendors were able to submit ready products to the testing labs and certification bodies for 2014 Edition certification. Eligible professionals could opt to use 2014 Edition certified products to comply with Meaningful Use (MU) beginning in CY 2013, and the new certification status became mandatory in CY 2014. Most HIT products were not ready to be 2014 Edition certified in time for prior MU participants to take advantage of that flexibility in CY 2013 due to their yearlong reporting period. However, new MU participants only had a 90-day reporting period in CY 2013, and thus were encouraged to implement 2014 Edition certified products instead of implementing 2011 Edition products (to avoid having to upgrade again so soon).
As CY 2013 wore on, it became clear that many vendors who had commercially successful 2011 Edition certified products were not getting new versions of those products updated and submitted for testing/certification in a timely fashion. By the time most vendors were ready, there was an alleged backlog of products in the testing and certification pipeline, which apparently caused more delays.
CMS and ONC soon realized that many prior MU participants were unable to implement 2014 Edition certified versions of the products they used before in time to demonstrate MU in CY 2014. So, in March 2014, CMS announced a new significant hardship exception for prior participants who had experienced vendor issues in 2014. Then, in May 2014, CMS and ONC published the proposed rule to (potentially, if finalized) allow participants to use their old certified software.
The May proposed rule was extremely late; perhaps too late to make a practical difference. The 60-day public comment period for the proposed rule will close on July 21, after which the agencies will need to review the comment submissions, develop the final rule, go through internal and Administration review, and get it published in the Federal Register before the beginning of the fourth quarter of CY 2014 (the last opportunity to begin a special reporting period). This part of the federal rulemaking process usually takes a few months at best, even when prioritized and expedited, and a significant portion of the time prior to a final rule’s publication is in the hands of reviewers in the Department and the Office of Management and Budget—not in the hands of those writing the rule at the agency level.
This promises to be one of the fastest conventional notice-and-comment rulemakings in recent CMS memory, but only time will tell if it will eventually be effective in helping physicians. Essentially, CMS and ONC are relying on MU participants to take a massive business risk and make implementation/participation plans based on a proposed (not final) rule, subject to change. Given the tight timing, it would have been preferable for the agencies to implement this via a Direct Final Rule (although DFRs are risky because they require there to be no substantive adverse comments), or even better, via an Interim Final Rule (IFRs merely require good cause to forgo the NPRM process). The agencies could have also held a minimum 30-day instead of a 60-day public comment period to expedite the rulemaking, considering it is unlikely they will get anything but support from the main stakeholder communities of eligible professionals, eligible hospitals, and vendors.
The question I often get is: if these proposed changes are eventually finalized without modification, would it help? I believe the timing is so short that it will only aid those who have previously participated in MU using 2011 Edition certified products (i.e., those products have already been implemented), and have no alternative compliance options in the fourth quarter of CY 2014 other than to cross their fingers and plan for the final rule’s new flexibility before it exists. That said, it would be risky and imprudent to advise anyone to make compliance plans based on a proposed (not final) rule.
On July 3, the American College of Radiology (ACR) submitted comments to the Food and Drug Administration (FDA), Federal Communications Commission (FCC), and Office of the National Coordinator for HIT (ONC) regarding the agencies’ report on a proposed strategy for a risk-based regulatory framework for health IT. The agencies were mandated by a provision in the FDA Safety and Innovation Act of 2012 (FDASIA) to draft recommendations that appropriately balanced HIT safety with innovation and avoided overlapping jurisdictions.
The report called for a risk-based, three tier categorization scheme for HIT functionality. FDA would continue to regulate the highest risk “medical device” IT functionality as before, and would not expand into new areas of oversight. ONC, in collaboration with the private sector and a future public-private HIT Safety Center, would promote HIT safety through non-regulatory activities for the middle tier “health management” IT functionality. Functionality in the lowest risk “administrative” category (billing systems, etc.) would not be a safety concern.
The ACR participated in several federal efforts leading up to the proposed framework, including the FDA’s mobile medical applications guidance activities in previous years and a FDA-FCC-ONC meeting addressing the FDASIA HIT report in May 2014.
According to recently released Medicare/Medicaid EHR Incentive Program data from the Centers for Medicare and Medicaid Services (CMS), 4576 diagnostic radiologists, 1513 radiation oncologists, 210 interventional radiologists, and 92 nuclear medicine physicians have attested to at least one year of Meaningful Use (MU) as of the end of 2013.
Only 16 diagnostic radiologists—in what appears to be at least four locations—used 2014 Edition certified EHR technology for MU in calendar year (CY) 2013.
The file was posted on May 31 and the metadata was updated on February 28. It is unclear if the data set also contains the March 2014 attestations for CY 2013 reporting periods. As you may recall, CMS extended the attestation deadline by one month for CY 2013 reporting periods.
Earlier today, the Office of the National Coordinator for HIT (ONC) released an update to the 2014 Edition Test Method that supports the testing and certification of health IT products used in the Medicare/Medicaid EHR Incentive Program. Specifically, the test procedure for the key “automated numerator recording/automated measure calculation” certification criterion was modified. Also updated were the test data associated with that procedure, and the test data associated with the procedure for the “data portability” criterion.
While primarily meant for testing labs and certification bodies, the 2014 Test Method is also an important resource for industry because it essentially shows how functionality will be tested against ONC’s various certification criteria. This allows for more efficacious planning prior to product submission.
Earlier today, the HHS Office of the National Coordinator for HIT (ONC) announced the release of its paper, “Connecting Health and Care for the Nation: A 10-Year Vision to Achieve an Interoperable Health IT Infrastructure.” The paper broadly covers issues and activities pertaining to interoperability and identifies five general building blocks for a nationwide interoperable HIT Infrastructure:
- Core technical standards and functions: ONC will use its existing Standards and Interoperability (S&I) Framework to enable the volunteer standards development community to advance core standards for terminology, content and format, transport, and security.
- Certification to support adoption and optimization of health IT products and services: ONC will use its HIT certification program and certification criteria regulations to enhance interoperability on a broad scale.
- Privacy and security protections for health information: ONC will identify and resolve weaknesses/gaps in privacy and security in various exchange models and invest in methods that support distributed analytics and open evidence without sharing PHI.
- Supportive business, clinical, cultural, and regulatory environments: ONC will work with stakeholders to resolve the ever-present cultural and business barrier to health information exchange.
- Rules of engagement and governance: Through standards, policies, and services, ONC will facilitate trust and interoperability across various networks and stakeholders.
The building blocks were informed in part by ONC’s March 2013 Request for Information (RFI) on advancing interoperability and health information exchange. ACR submitted comments in response to that RFI on April 15, 2013.
The application deadline for obtaining one of the significant hardship exception options from calendar year (CY) 2015 EHR Incentive Program penalties is July 1, 2014. Beyond the application-based hardship exception options, there are automatically-granted significant hardship exception options for newly practicing physicians and physicians whose primary specialty codes in PECOS are “diagnostic radiology” (30), “nuclear medicine” (36), “interventional radiology” (94), anesthesiology (05), or pathology (22) as determined approximately six months prior to the penalty year (so, also July 1, 2014).
Importantly, most American College of Radiology members will not need to take any further action to avoid the CY 2015 penalties other than to double-check their own PECOS data to make sure their primary specialty code is 30, 36, or 94. Radiation oncologists and other radiologists with different primary specialty codes will need to either demonstrate Meaningful Use (MU) by the appropriate deadline in 2014 or manually apply for one of the other significant hardship exceptions before July 1.
- ACR.org MU Resource Center
- ACR Pocket Guide to MU in 2014
- How to Avoid MU Penalties
- MU Significant Hardship Exception for Radiologists Clarified
CMS to Publish Proposed Rule to Allow Continued Meaningful Use of 2011 Edition Certified EHR Technology in 2014
On May 23, 2014, the Centers for Medicare and Medicaid Services (CMS) will publish a Notice of Proposed Rulemaking (NPRM or “proposed rule”) that, if finalized, would allow EHR Incentive Program participants to continue to “meaningfully use” 2011 Edition certified EHR technology (CEHRT) in 2014, among other things. Currently, all participants in Stage 1 or Stage 2 Meaningful Use (MU) need 2014 Edition CEHRT in 2014 and beyond.
As a reminder, there is also a separate, ongoing rulemaking within the Office of the National Coordinator for HIT (ONC) that would introduce the availability of “2015 Edition” EHR certification criteria as an alternative to the 2014 Edition criteria for the certification of products used in the program. The American College of Radiology’s comments on the 2015 Edition rulemaking are available online.
The May 23 NPRM will have a public comment period of 60 days, so CMS and Office of Management and Budget will need to expedite the subsequent finalization and review processes to promulgate a final rule before the 4th CY quarter (October) final reporting period start time for prior MU participants. There has been no explanation as to why CMS used a NPRM process for something this time sensitive versus the quicker interim final rule or direct final rule processes.
On May 14, the American College of Radiology (ACR) participated in the Food and Drug Administration (FDA), Office of the National Coordinator for HIT (ONC), and Federal Communications Commission public workshop on a risk-based strategy and framework for ensuring HIT safety and innovation. Dr. David Hirschorn (member, ACR IT and Informatics Committee) represented ACR on the expert panel that addressed clinical decision support subtopics. A webcast recording of the meeting should be available on the FDA’s website within the coming weeks.
On May 8, the American Medical Association (AMA) sent a letter to the Centers for Medicare and Medicaid Services (CMS) and ONC in response to a request for feedback on the Medicare/Medicaid EHR Incentive Program. The ACR and other national specialty societies provided input to the AMA in preparation for this letter. The letter calls for a radical reinvention of the EHR Incentive Program starting with a more flexible modification of the existing framework and ending with a return to the basic MU parameters of the statute.
On May 15, ONC announced that the HIT Policy Committee-MU Workgroup will convene two listening sessions for EHR Incentive Program participants, vendors, and other stakeholders. The May 20 listening session will include participating eligible professionals and eligible hospitals. The May 27 listening session will include payers, Regional Extension Centers, industry, and others. A series of questions to guide these sessions are available on ONC’s Health IT Buzz blog.
On May 16, CMS announced the availability of attestation process guidance for EHR Incentive Program participants in Stage 2. The relatively new resources include a robust guide and abbreviated worksheet.
In accordance with the Office of the National Coordinator for HIT’s (ONC) new policy to limit HIT Policy Committee (HITPC) members’ service to six years, three members of the original 2009 roster rotated off after yesterday’s monthly meeting. Leaving are Dr. Arthur Davidson (Denver Public Health Department), representing advocates for patients or consumers; Dr. Neil Calman (The Institute for Family Health), representing expertise in improving the health of vulnerable populations; and Judith Faulkner (Epic Systems Corporation), representing IT vendors. Replacing them are Kim J. Schofield (Lupus Foundation), Dr. Christoph Lehmann (American Academy of Pediatrics), and Neal Patterson (Cerner Corporation), respectively. Individual HITPC members have left in the past due to career changes or other voluntary reasons.
Interestingly, Dr. Paul Tang was reappointed without an opportunity for public nominations for a third consecutive term as the physician representative and vice chair of the HITPC. Dr. Tang is the leading non-staff member of the HITPC and chair of the Meaningful Use (MU) Workgroup. Arguably, no other private sector individual has played a bigger role in helping shape CMS and ONC’s regulatory implementation of the EHR Incentive Program. It appears Dr. Tang will continue to lead the HITPC until his latest three-year term expires in 2017—eight years after the committee’s establishment, and two years beyond the service limit imposed on the other members.
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.