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ONC, CMS proposed rules step in the right direction, but pitfalls remain

Released during HIMSS and now nearing the end of their comment period, two proposed rules have been the talk of the industry ever since. This long-awaited guidance is critical to further encouraging the secure sharing of health information to support patient care and national health policy goals.

The Office of the National Coordinator for Health IT (ONC) released its proposed rule, 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program. The Centers for Medicare and Medicaid Services (CMS) also released a proposed rule that addresses interoperability, information blocking and patient access to health information.

The rules are broad, and they are very assertive in the topics explored and the timelines proposed – possibly, I think, exhorting more than Congress intended in some cases. Interestingly, both touch several constituencies within our industry not always included in health IT-related regulations, and I applaud the direction these rules are taking. Our feedback to be submitted in the coming weeks will highlight the following strengths and issues with the proposed rules:

Strengths of the ONC proposed rule 

Information blocking exceptions – Information blocking, even where defined in the 21st Century Cures legislation, is a complex and nuanced action to identify. The ONC-proposed rule is required to lay out what does not constitute that prohibited activity, and they have succeeded in creating seven credible and thoughtful buckets that address areas of industry concern.  For example, it allows for privacy and security exceptions, as well as those for situations where the exchange of information might cause harm to the patient.

Focus on Application Programming Interfaces (APIs) The rule emphasizes the opportunity from the use of APIs for several interoperability use cases, and there are noteworthy changes to the certification criteria. I strongly support this push to expand APIs. Allscripts was the first in the industry to offer open API access to our EHRs. Those APIs have enabled almost 6.5 billion data exchange transactions. We continue to actively participate in API-related standards development efforts, such as the DaVinci Project.

Trusted Exchange Framework and Common Agreement (TEFCA) requirements We support requirements tied to participation in TEFCA, but the final rule should specify participation and standardize technical criteria across the new Health Information Networks (HINs). For TEFCA to be successful and not burdensome, HINs need to meet a consistent technical bar and not require greater specialized, unique technical support. ONC should also explore with CMS whether participation in TEFCA should check the box on other information exchange or anti-information blocking requirements.

Calls for transparency ONC’s calls for more open communication and transparency are legitimate. For example, the industry would benefit from more open contribution of screen shots to industry efforts to improve usability or address patient safety concerns. We also agree that providers should not be prohibited from raising patient safety issues, for example through so-called “gag clauses” or non-disparagement rules.

Concerns about the ONC proposed rule

Expansive definitions in cost recovery and intellectual property (IP) licensing Some concepts in the ONC rule could pose challenges in terms of practical implementation and enforcement, in addition to going further than was intended by Congress.  While the concept of RAND (Reasonable and Non-Discriminatory) terms is a good fit for standards development, it is too expansive to apply to software development given the discrepancy between voluntary and compulsory contribution models. As the proposed rule is written, Allscripts fears that a requirement to license nearly every solution – a concept that seems an abrogation of normal patent protections – would effectively penalize those investing in technology evolution.  When coupled with the proposed cost recovery exception, which would undermine free market pricing influences and essentially limit profit opportunities, the proposals in this area seem to discourage innovative investment.

APIs don’t solve every problem – APIs promise tremendous opportunity (and Allscripts welcomes the elevation of APIs), but we hope the ONC recognizes they may not be the optimal interoperability solution in every instance and that significant moneys have been invested in other interoperability mechanisms that are in use across the industry today. Though we are eager to see rapid progress, we caution against tossing models that are working or pushing too fast, before market readiness, to apply APIs to all use cases.

Proposed timelines – HHS was more than a year late in issuing these proposed rules, and we appreciate their thoughtfulness and deliberate pace in attempting to craft the right approach.  Nonetheless, the extra time taken in drafting the proposals is being reflected in compressed timelines for development and implementation. There simply is not enough time being allowed for the heavier work required of software developers or the implementation and testing necessary within our clients’ environments.  We want the agencies to be successful, and we suggest the greater chance of that happening exists with more sufficient time allowed.

About the CMS Interoperability rule

The CMS rule is largely geared towards payers and the extensive work they would need to do to increase the flow of data they have on covered patients. I’m enthusiastic about seeing them share more of their information with the industry. A few other observations:

Possibility of overlap – There is potential for duplication in requiring health plans and payers to offer greater patient access to claims data (and some limited clinical data) via APIs, given that patients already have so many different places they need to go for their health information. However, we expect the industry will work that out and see it as the potential for new areas of innovation. 

Addressing price transparency – Many concepts within the CMS rule that require health plans to share data would contribute positively to the efforts around price transparency. Looking past medication price transparency, which is already available today, other areas of pricing – such as lab, imaging, procedures and other treatments – are going to be harder to open up. They cannot be compared, apples to apples, in the same way that medication pricing can because of a lack of standardization, but freeing the information would be a huge step in the right direction.

Easing patient transitions of care – CMS has proposed requirements designed to better track patient transitions of care and notify clinicians of a patient’s movement associated with the hospital. The requirement won’t be without challenges for software developers, given the need to ensure that the exchanged information can be appropriately presented to clinicians in the ambulatory and post-acute space, but it is the right thing to do.

Important Requests for Information (RFIs) – There are several RFIs within the CMS rule that are important. In particular, Allscripts will request that The Center for Medicare & Medicaid Innovation (CMMI) consult health IT vendors during the conceptualization and program development phases of its demonstration projects. An inclusive planning process would allow vendors additional time to design and develop solutions that enable program success, especially for models designed for non-certificated healthcare settings such as behavioral health, or those addressing social determinants such as school, housing and food insecurity data.

Many technical issues around information exchange have been solved. Information can flow today between virtually every system on the market through a variety of mechanisms. There simply is no need for small physician practices, for example, to have to replace their current EHR to be able to exchange information with their local hospital. I appreciate that these proposed rules attempt to address the wide variety of possible “information blocking” incidences, and the specificity with which ONC, CMS and the Health and Human Services (HHS) Office of the Inspector General (OIG) attempted to address the issues at hand.  We will ask, however, that timelines for implementation be more reasonable and that a hard second look be taken at where some of the proposals discourage innovation.

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