Proposed rule to strengthen ONC's health IT review raises concerns
- CMS recently proposed a rule that aims to provide ONC with the authority to review certified healthcare IT products and take actions to correct non-conformities.
- This has raised concerns among healthcare IT vendors and associations, including the possibility that ONC may extend its reviews beyond certified capabilities, or could suspend or terminate a vendor's meaningful use for a product or a quality measure within a product until an issue is fixed.
- The rule also includes processes for ONC to authorize and oversee accredited testing labs under the ONC health IT certification program.
ONC said it wants to be able to respond quickly to potential systemic issues, including interoperability and data exchange issues and problems that hold potential risk to public health, safety, security, or privacy.
Just a day after the proposed rule was published, GE Healthcare filed 35 pages of comments, which included concerns that the rule would give ONC more authority than Congress intended in the HITECH Act.
Mark Segal, vice president of government affairs and policy at GE Healthcare IT, said the rule would enable ONC to arbitrarily determine which vendors are not conforming with certified health IT via its own determination of rules since the agency is proposing to expand its authority without new certification criteria.
HIMSS' letter to ONC also raised concerns and encouraged the agency to use the rule to "promote improvements via policy action rather than punitive approaches that focus on certification suspension and/or termination processes." The letter also recommended to more specifically define the circumstances for ONC's intervention.
Health IT Now, a coalition of patient groups, provider organizations, and employers that support health IT to improve care quality, submitted comments in a letter that outlined concerns the proposed rule will "not only overstep ONC's legal authority but also create more uncertainty in the marketplace for health IT vendors." The group also stated the rule does not clearly state in what instances ONC will exercise direct oversight of certified capabilities and urged clarity on this, as HIMSS did in their letter.
The College of Healthcare Information Management Executives (CHIME) submitted three recommendations in response to the proposed rule:
- ONC collaborates with CMS to minimize the impact of suspended or decertified products on provider reimbursement;
- Use termination of certified health IT as a last resort; and
- Provide safe harbors for providers with products under appeal or that become decertified.
The organization urged ONC to consider their concerns before finalizing their proposal.
- Federal Register ONC Health IT Certification Program: Enhanced Oversight and Accountability
- Health Data Management GE Healthcare questions ONC authority to change MU