WASHINGTON—Electronic health-record vendors would have until Jan. 1, 2018, before facing stiff penalties for a lack of data-sharing in the newest version of the 21st Century Cures Act.
The addition is the latest to the smorgasbord of incentives, appropriations, deregulations and regulatory streamlining that make up the 21st Century Cures Act, a legislative package developed by the House Energy & Commerce Committee and intended to kick-start biomedical innovation.
The revised bill—released Wednesday morning—is difficult to digest in one sitting, and touches on many areas of controversy. For example, consumer advocates may be concerned by the restoration of exclusivity periods for drugs treating rare or pediatric diseases, which had drawn criticism in previous iterations of the bill.
But the most significant addition may be the tough interoperability provisions for EHR vendors, intended to ensure that there are no technical or economic barriers obstructing providers from sharing clinical data.
“(I am) still reviewing the details, but (am) pleased by the focus on information blocking and the teeth given those provisions,” said Dan Haley, vice president of government and regulatory affairs at Athenahealth, a cloud-based EHR firm that has campaigned for tougher interoperability provisions.
“(My) first take is that it's improved,” said Jeff Smith, senior policy adviser at the College of Healthcare Information Management Executives, though he cautioned it was too early to tell for sure.
The bill works on two tracks. After passage, HHS would be given $10 million to contract with a “charter organization” that would, in concert with the agency, develop metrics to assess the state of interoperability in the healthcare system. That would result in a public July 2016 report describing whether interoperability existed, and the capability of vendors' software to fulfill that mission.
Then, on Dec. 31, 2017, the agency would publish a follow-up report specifying whether given vendors' software was in compliance with certification requirements surrounding interoperability.
For vendors, the teeth of the bill grow in January 2018: that's when they would be required to attest that their software is in compliance with interoperability provisions. These include a lack of barriers to sharing information; financial information regarding the pricing of data transmission; application programming interfaces, which provide outside developers and users with a set of instructions for accessing EHR data; and satisfying HHS' request to allow for “everyday” data exchange.
Should vendors fail these tests, the threat of decertification looms: that is, the software would not be eligible for use in the government's EHR incentive program. Such an action would effectively deplete the market for that given software.
Critics have argued that such decertification would not merely hurt vendors, but the providers who rely on their software. A provider cannot use decertified software and qualify for the incentive program. Under the status quo, then, a provider would either have to take the Medicare payment penalty or switch EHRs at great expense.
The bill, however, gives HHS the authority to extend hardship exemptions to providers who are using decertified software. That exemption period must be at least one year, and can last up to five years, at the agency's discretion. The bill also overhauls patients' rights with regard to their health data, though the exact effects are unclear.
Patients “have the right to the entirety of the health information contained in the electronic health record,” the bill declares. But it doesn't follow up on the specific complaints of patient advocates, who have argued that such data is available—but with a time lag or exorbitant cost.
The bill also declares that healthcare providers do not need patients' consent to share data for their care, which many providers and software vendors had interpreted as necessary under the Health Insurance Portability and Accountability Act. An exception is made for certain conditions, such as psychiatric records, where regulations explicitly specify a need for patient consent.
Much of the bill is notable for what it's missing. For instance, Democrats and many outside experts say additional resources are needed for the FDA to shoulder new burdens built by the bill: for example, to perform some of the new programs related to biomarkers or breakthrough review. It doesn't appear that such additional appropriations are there, however.