Costs could stifle innovation, new requirements could add to provider burden, and the President's budget blueprint might not provide the government resources needed to support the proposed rules.
As the May 3 deadline approaches for comments related to proposed rules from the U.S. Department of Health and Human Services (HHS) to support seamless and secure access, exchange, and use of electronic health information, the Healthcare Information Management Systems Society (HIMSS) conducted a press briefing on Thursday.
The session offered a glimpse into the direction of commentary from HIMSS, as well as concerns it is hearing from its constituents, including health systems.
The Office of the National Coordinator for Health IT (ONC) and the Centers for Medicare & Medicaid Services (CMS) are "trying to use all available policy levers to push interoperability data exchange forwards," says Jeff Coughlin, senior director of federal and state affairs for HIMSS. "The idea about placing patients at the center of the healthcare ecosystem is important as well."
"It's hard to overestimate how complex this is," he continues. "The work that ONC and CMS put into designing this broader exchange of information speaks very well of them, but also, [it] is complex in terms of interpretation and implementation across the community."
HIMSS provides the following background about the issue:
- On February 11, CMS and ONC released proposed rules that focus on ensuring that health information is shared across the entire care continuum, including with patients.
- The CMS proposal attempts to advance interoperability from the patient perspective, by putting patients at the center of their healthcare and confirming that they can access their health information electronically without special effort.
- The ONC proposal calls on the community to adopt standardized application programming interfaces (APIs) and presents seven reasonable and necessary conditions that do not constitute information blocking.
Following are eight key takeaways from the press briefing with Coughlin and Tom Leary, vice president of government affairs for HIMSS:
- The cost of compliance could stifle innovation. One issue of major concern to health systems is the compliance costs that will be required to meet the proposed requirements, particularly related to the ONC rule. With limited resources across developer and provider communities, Coughlin says constituents are concerned that it may "stifle innovation."
There is a fear that current players may have to spend "an inordinate amount of time trying to comply with all of these requirements and not be able to think for themselves or think for their own organization," says Coughlin. In addition, there is interest in ensuring "that there is still opportunity for new market entrants to come into come into the field to think about different ways that we could be sharing data and empowering patients."
- New rules could complicate efforts to relieve provider burden. "Finding the balance between the administration's push for toward value-based care and making sure that you're keeping the Medicare and Medicaid providers moving down that path without overly burdening them is a real tightrope that the administration is trying to walk with these two regulations, particularly as they're responding to the requirements of patient access to data," says Leary. HIMSS plans to address this in its comments.
- Price transparency could be too transparent. HHS is increasing its focus on pricing transparency, says Coughlin, alluding a couple of weeks ago to perhaps publishing negotiated rates between hospitals and payers.
"I think HHS is looking into what's included in the ONC rule related to pricing," he says. "It's important to emphasize there is a request for information that's included in there related to the inclusion of pricing information in electronic health information. That's something that we're really trying to drill down on and figure out if that is an appropriate step to take."
- Definitions of key terms are crucial. There are a lot of questions about specific terms and concepts, say HIMSS representatives, including Electronic Health Information (EHI) "One of the components that's included there is around pricing and health insurance eligibility benefits," says Coughlin. "It's something we are taking a close look [at along with] the difference between Health Information Exchanges and Health Information Networks." He adds that it would be helpful to have examples such as the ones the ONC provided for the exceptions to information blocking.
- There are issues related to patient data matching. Both regulations reference patient data matching as opposed to a unique patient identifier, Leary points out. "HIMSS has a lot to say around what the right attributes of a patient data matching algorithm might look like [and] the cost of implementing various solutions. We'll make sure that our response provides the government with additional insight on that area."
- No API standardization will add a layer of complication. There is a lot of excitement that both rules specify the use of Fast Healthcare Interoperability Resources (FHIR) standards to update existing criteria about APIs. However, meeting the proposed requirement around patient access without special effort, will be a big challenge for organizations says Leary, particularly if APIs have not been standardized for whatever version of FHIR is in use when the rule becomes final.
- ADT conditions stimulate great interest. Adding ADT (Admit, Discharge Transfer) feeds as a condition for participation in CMS is a major step, according to Coughlin. Health Level Seven (HL7) ADT messages communicate a change in a patient's status or update to demographic information. "That is something that a lot of folks are focused on when thinking about the proposed rules," he says.
- Will the budget be able to support the additional work and resources needed, particularly by ONC? While not directly related to the proposals, President Trump's recently released budget blueprint stimulated concerns about the ability for the government to support the proposed rules, according to HIMSS representatives.
"Looking at the [president's] budget blueprint and looking at what's included in terms of resources for the Office of National Coordinator, the Office of Civil Rights (OCR), and so on, there are enforcement duties that ONC, OCR, and the Office of the General Counsel have to take on within HHS to enforce a lot of the provisions included in the rule," says Coughlin. "The question around the commitment to resources for those agencies is important because there is obviously more work and different work that's going to be a part of ONC's portfolio, in particular. How that works with the budget and the resources that the agency has is something that we're going to try to figure out."
“It's hard to overestimate how complex this is.”
Mandy Roth is the innovations editor at HealthLeaders.