Successful organizations must cut through the confusion and added costs to comply with new regulations.
On April 5, after years of consideration, the U.S. government for the first time will implement laws intended to combat the longtime practice in the healthcare industry of blocking the flow of patient information (authorized by patients under HIPAA), from one provider to another.
Arising out of language in the 21st Century Cures Act, the final rule issued by the HHS Office of the National Coordinator (ONC) poses challenges to an industry still in the midst of combatting the COVID-19 pandemic.
The profound impact of this rule is only beginning to be felt by the industry, according to Leigh C. Burchell, vice president of policy and government affairs at electronic health record (EHR) supplier Allscripts, and chair of the Electronic Health Records Association's public policy leadership workgroup. Recently, Burchell discussed these implications with HealthLeaders.
HealthLeaders: The ONC applicability date is April 5, but HHS hasn’t put out a proposed rule about disincentives for provider organizations related to information blocking and the OIG (Office of the Inspector General) final rule isn’t expected until summer. What does this web of regulatory timelines mean to the industry?
Leigh Burchell: There is a sizable amount of industry confusion because of the disconnect between the April 5th applicability date from ONC and the lack of regulatory finality from OIG and HHS. My guess is that a number of people won’t take it as seriously as they should until all of those rules are out, and I know that many are advocating for a final approach from OIG that allows for a learning period before any type of disincentive is applied. It’s a big rule and frankly, a confusing one, with a lot of ambiguous language, so it’s reasonable to hope that the regulators will allow some time for people to learn and adjust before any more serious steps are taken.
HL: Transparency into cost and outcomes has been a recent focus of the rule. Are the current policies and processes of physician practices up to the mission?
Burchell: I think the issue of policies and processes is the bigger barrier to information blocking regulatory compliance for most healthcare organizations, as compared to the technology. Some hospitals and practices have been under the impression that companies like Allscripts will release a new EHR version that will address all of their obligations, but that is not how this regulation is structured. Practices need to take a look at their processes for responding to requests that come in for patient data to the best of their ability, whether from another provider, a public health entity, or a patient, and critically, for capturing information about those instances when a request cannot be honored in order to explain the decision to any investigator from OIG who comes knocking. It’s a rule that can have a pretty stiff price as far as administrative and compliance burden, so organizations are really going to want to take a thorough look at whether they’re doing everything they need to.
Leigh C. Burchell, vice president of policy and government affairs, Allscripts (Photo courtesy of Leigh Burchell)
HL: Authorization is a complex process that suggests that practices have quite a lot of overhead when disclosing protected health information (PHI). Is EHR software instrumented to simplify that process, or does the software itself require retooling?
Burchell: Certified EHRs currently offer a number of options to practices and hospitals who will be assessing the best way to comply with the new requirements around information sharing. For exchange with other providers, there are easy-to-use options, like sending C-CDAs or clinical notes through Direct Messaging if they aren’t otherwise connected to a larger health information exchange infrastructure. And for patients, data related to problems, medications, allergies, lab results, and diagnostic imaging results can be accessed through their personal health record or patient portal, while patient-directed exchange mechanisms like APIs and those supporting view/download/transmit requirements have been available for several years. Provider organizations will need to take a look at their policies and procedures, however, to ensure their systems are optimally configured to make that patient data accessible as quickly as possible and with as much depth as possible to meet the requirements around the USCDI.
HL: Will small practices simply attempt to invoke the "infeasibility" exception to the information blocking rule, and why won't that suffice in the short term?
Burchell: The first inclination for many small practices will be to invoke infeasibility, but they need to be aware that to do so requires a specific process of reviewing alternative means of getting the requested data to the patient or other inquiring party before they can turn to the infeasibility exception. If they jump to infeasibility without first going through the steps required of the content and manner exception, their infeasibility claim will be invalidated. They also have to document that process contemporaneously, meaning at the same time and per individual request, not just through a blanket policy, so they may find that it becomes an untenable use of resources to document infeasibility with any level of regularity. We’re encouraging our clients to use this as an opportunity to assess their information exchange and care coordination strategy, because it might be time to increase their Direct Messaging efforts, finally connect to an HIE or invest in HIE technology, or ensure that the personal health record they offer their patients is robust and capable of sharing as much data as is expected by this regulation.
HL: Do the remedies suggested here add to the cost of health IT, and if so, who will ultimately pay that cost?
Burchell: Allscripts has assigned significant resources to complying with this regulation, and some of the changes will require substantial work. Additionally, providers across the industry have to assess for themselves what changes they need to make to successfully be able to respond to data requests, including the health IT solutions they are using, and for some, that will mean additional investment could be necessary.
HL: Could these requirements accelerate the trend of small practices selling out to larger organizations?
Burchell: Independent physician practices are a critical backbone of the healthcare ecosystem in this country, and that’s particularly true in underserved and rural environments. I certainly hope that HHS is mindful of the impact of this massive regulation and closely keeps an eye on whether adjustments are needed if they find that it’s negatively impacting the ability of those practices to continue to thrive. Pushing for expanded information exchange is the right thing to do, but finding that right balance will be key.
“Pushing for expanded information exchange is the right thing to do, but finding that right balance will be key.”
Leigh C. Burchell, vice president of policy and government affairs, Allscripts, and chair, public policy leadership workgroup, Electronic Health Records Association
Scott Mace is a contributing writer for HealthLeaders.
Consider implementing easiest options first, such as sending C-CDAs through Direct Messaging, EHR industry leader says.
Organizations need to look at their processes for responding to public requests.
Continuing lack of final regulations regarding enforcement of the rule will delay adoption.