The House Energy and Commerce Committee released an updated version of the 21st Century Cures bill this week, which could overhaul the way medical innovations are regulated in the U.S.
The bill mostly focuses on the National Institutes of Health (NIH) as well as device and drug innovation, but many elements specifically touch the health IT world. Most prominently the bill includes language promoting the interoperability of electronic health records and health IT systems. Starting in 2018, the bill would enact penalties to vendors that are not in compliance with interoperability criteria set by the Health IT Standards Committee and a charter healthcare development standards organization.
The interoperability language does not include anything on a patient identifier. This has drawn the ire of the College of Healthcare Information Management Executives (CHIME), which sent out an official statement a few hours after the bill was released to the public.
“Interoperability is a complex, multifaceted problem that will only improve when we have a standardized approach for collecting and sharing data, but that can only occur once a patient has been positively identified. Despite the Energy & Commerce Committee’s efforts to evaluate and enhance health information exchange, CHIME is disappointed that the Committee failed to include language recognizing the ongoing challenge posed by the inability to match patients across care settings,” the advocacy group said in a statement.
The previous version of the bill was released in late April and did not include any specific language on interoperability of EHRs. This frustrated health IT stakeholders, such as Premier Inc., a Charlotte, N.C.-based company that offers group purchasing, consulting, informatics and advocacy services for hospitals and health systems. Premier wrote a letter to the Committee urging that interoperability standards and transparency elements become a part of the bill. The company was much happier with the updated bill.
"We are very pleased with the legislation, as it stands today. In our recommendations (attached), we called for standards that promote interoperability and innovation, particularly through the use of open application programming interfaces (APIs); transparent and public interoperability measures; and enforcement mechanisms to ensure compliance. All of these recommendations were included in the Cures bill. If these principles remain intact, we are hopeful that we will finally have a strong policy framework that incents open source infrastructure and interoperability among disparate systems in healthcare. This is an essential step to optimize HIT investments, improve the quality of care across settings and avoid the cost burdens associated with the work around solutions that are needed today for systems to “talk” to one another," a representative of the company said to HCI.
The updated bill also includes language on telehealth. It calls for State medical boards to come together to create common licensure requirements for providing telehealth services and calls for appropriate expansion of telehealth coverage for Medicare beneficiaries.
This wasn't enough for the American Telemedicine Association, the Washington D.C.-based advocacy group expressed disappointment in Congress for "hitting the snooze button" on substantive legislation.
“It appears that the staff and members of the Committee have once again been led by CMS and the Congressional Budget Office into asking for a study instead of taking real action,” Jonathan Linkous, CEO of ATA, said in a statement. “These studies are ‘snooze buttons’ that allow CMS to delay any action for years. Unfortunately, this is not the first time this has occurred. Fifteen years ago CMS also convinced Congress to ask for a study instead of taking action - but the agency has yet to deliver that report. We suspect the same will occur this time around as well.”
The bill, which is being championed by Rep. Fred Upton (R-MI), who is Chairman of the House Energy and Commerce Committee, has a scheduled mark up on Thursday of this week. It is a product of the Committee’s 21st Century Cures initiative, which began a year ago.
“Every step in this process has been hard fought, not for our own interests, but for those who suffer. Every policy has been scrutinized, every voice considered. We’ve pushed harder and faster than anyone thought possible, because we know patients cannot wait. They need 21st Century Cures now,” Upton said in a statement.