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Archive for July, 2014

Not For Everyone: Proposed Last Minute Meaningful Use Flexibility is a Gamble

July 15, 2014 2 comments

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.

Background

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 Concern

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.

Conclusion

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.

Categories: EHR, meaningful use, Medicare

ACR Submits Comments to FDA, FCC, and ONC on the FDASIA Health IT Report

July 7, 2014 1 comment

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.

Categories: EHR, FDA, IOM, radiation safety