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As it nears the end of its third week, the government shutdown continues to throw a wrench into the release of federal health IT rules that are expected to affect healthcare policy.
Rules and regulations proposed by CMS and the Office of the National Coordinator for Health IT (ONC) hang in limbo, as the shutdown continues to affect various organizations that are responsible for reviewing and approving rules and regulations.
While the government shutdown is in effect, Jeffery Smith, vice president of public policy for the American Medical Informatics Association (AMIA), said healthcare professionals should not expect to see progress on rolling out the new rules and regulations anytime soon.
Shutdown affects release of CMS interoperability rule
One of the most anticipated rules in the healthcare community is a new CMS interoperability and patient access rule. Many expected it to be announced in December -- Smith said he's unsure of a cause for the delay. Now that there is a government shutdown, he said it complicates when the rule will be announced.
"Since the government can't operate when it doesn't have a budget, those rules won't be coming out while the government is still shut down," Smith said.
No budget means organizations like ONC and the Office of Management and Budget -- where the CMS interoperability and patient access rule is currently under review -- can't function normally.
The shutdown means the proposed CMS interoperability and patient access rule won't be released, and it's also responsible for the cancellation of the January Health IT Advisory Committee meeting, during which work on interoperability standards was supposed to wrap up.
Smith said he believes the shutdown is negatively affecting the healthcare space, because it delays federal officials from discussing what's in the proposed rules, as well as a long cadence of activities associated with rule review.
"These rules will be out for 60 days for comment, maybe even longer. Then, the government is going to have to interpret the feedback," Smith said. "When you have these persistent delays followed by a government shutdown, it inhibits the ability of policy to either engender a conversation that should be happening within the private sector, but isn't, or to correct bad policy that's currently out there."
What's in the CMS interoperability rule?
Smith said it remains a mystery as to what the CMS interoperability and patient access rule addresses, although it will be regulatory in nature and is touted as having a major impact within healthcare. It has also been given an "economically significant" priority, a federal designation that means it's predicted to have "an annual effect of $100 million."
Although not much is known about what the rule may entail, CMS Administrator Seema Verma has hinted at areas that may be addressed within the rule once it's announced, according to Smith.
CMS has telegraphed through Verma's speeches and through the Federal Register -- the government's official journal for rules, proposed rules and public notices -- that the agency is interested in crafting policy that makes data more easily and readily available for patients, he said.
Jeffery Smithvice president of public policy, American Medical Informatics Association
Smith said the CMS interoperability and patient access rule could also include information on revising requirements hospitals must meet to participate in Medicare, often referred to as Conditions of Participation.
"There's a high likelihood that the Conditions of Participation changes could include mandatory APIs for patients to access their information and requirements to provide ADT [admit, discharge, transfer] feeds to other providers," he said.
Mari Savickis, vice president of federal affairs at the College of Healthcare Information Management Executives, a professional organization for healthcare CIOs, echoed Smith's predictions, noting that the delay has a trickle-down effect.
"These rules will likely warrant technology changes, and that will then trigger vendor development before it can reach provider organizations and patients," Savickis said. "Naturally, delays of proposed rules also mean that the final rules will be later. It also stokes ongoing uncertainty for providers and vendors who await definitions around data blocking and further clarification of how CMS expects providers to implement APIs."
Smith said he's also anticipating the CMS interoperability and patient access rule to focus on Blue Button 2.0, an API from CMS that makes four years of Medicare data for 53 million beneficiaries accessible. The Blue Button 2.0 API aims to help patients and healthcare organizations access health data in one place.
Shutdown also delays release of ONC rule
Along with the CMS interoperability and patient access rule, Smith said he expects to see big changes from ONC, which he said have also been delayed by the government shutdown.
ONC spent the last year developing responses to sections of the 21st Century Cures Act, including a long-awaited rule on information blocking mandated by the bill. The 21st Century Cures Act, which was signed into law in 2016, is a wide-ranging bill that funds healthcare-related initiatives aimed at modernizing the system.
ONC's definition of what doesn't constitute information blocking is highly anticipated, and Smith said he'll be looking for changes to the ONC Health IT Certification Program through new "conditions and maintenance of certification" provisions required by the 21st Century Cures Act. The bill requires a several conditions be met by health IT developers, including that they do not prohibit or restrict communication regarding security or the usability of the technology.