With the comment period for two major rules set to close on May 3, the clock is now ticking for industry groups to dig into the proposals aimed at boosting interoperability and patient access.
Is 60 days enough time to unpack the rules?
The American Medical Association (AMA) says no, joining electronic health record vendors in calling on federal policy leaders to extend the comment period on the dual information blocking and interoperability rules dropped last month.
Both the AMA and the Electronic Health Record Association (EHRA), which represents most of the major EHR vendors, are asking for a 30-day extension on the rules’ comment period.
CMS is proposing to require Medicare Advantage organizations, state Medicaid and CHIP fee-for-service programs, Medicaid managed care plans, CHIP managed care entities and QHP issuers in FFS programs to implement, test and monitor openly published FHIR-based APIs to make patient claims and other health information available to patients through third-party applications and developers.
In letters to both Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma and National Coordinator for Health IT Donald Rucker, M.D., AMA president James Madara, M.D., said the proposed rules represent a "true paradigm shift in healthcare."
The proposed rules are “interwoven, complex in nature, and include multiple detailed requests for information," Madara wrote. "To ensure that the rules are as successful as possible in meeting your goals, it is vital that stakeholders be given adequate time to provide comprehensive, thoughtful, and detailed comments."
The 21st Century Cures Act includes many provisions that, through prudent regulation, will advance patients’ and physicians’ access to medical information, the AMA said.
“I recognize and appreciate the desire for swift rulemaking. However, such rapid change in health care policy, technology and business practices may lead to unintended consequences for patient privacy and physician burden,” Madara wrote.
Sequoia Project convenes information blocking workgroup
The ONC and CMS rules have ramifications for stakeholders across the industry, including payers, providers, vendors and health information exchanges, and for this reason, the Sequoia Project, a nonprofit that advocates for nationwide health information exchange, has formed a workgroup to review the complex policy, technical and business issues associated with the information blocking policies.
Sequoia Project CEO Mariann Yeager told Fierce Healthcare the workgroup membership will be a mix of government and private sector representatives, including industry associations, provider organizations, networks and service providers, technology companies, physicians and clinicians and individuals representing the interests of consumers and public health.
“We’ve also tapped individuals who have extensive legal and privacy experience with a hands-on understanding of information sharing policies and practices,” she said.
“We have 21st Century Cures policy now; this is really a fundamental shift and it will shape the future of health IT. It’s going to be imperative to have a more formal coordinated approach because we have to implement this,” she said.
The aim of the workgroup is to take a collaborative, targeted approach to understand the real-world, practical implications of the proposed rules, Yeager said, with a particular focus on the seven exceptions to information blocking, as proposed by ONC. “There is so much to unpack. We could literally spend months and months with analysis and detailed discussion. We need to make sure that we as a collective healthcare sector evolve to meet the aims of 21st Century Cures and that there’s a shared understanding across the stakeholder groups.”
She added, "Many organizations don’t have the resources to submit public comments but they have important insights to share. The information blocking workgroup provides a venue to allow groups to come and share their perspectives.”
The Sequoia Project is hosting an information blocking public forum March 19, the first of likely many public forums. The forum will provide an overview of the proposed information blocking policies and regulations from ONC and CMS, and enable public input on the work of the information blocking workgroup, Yeager said.