Today, two final rules were released that will have a major impact on all sectors of the healthcare system, and an especially large impact on the health IT sector. The Centers for Medicare and Medicaid Services (CMS) published the Medicare Program; Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models final rule and the Office of the National Coordinator for Health IT published the ONC Health IT Certification Program: Enhanced Oversight and Accountability final rule. Robert Horne, Executive Director of Health IT Now, issued the following statement:
“We are very disappointed that ONC has decided to move in this direction. Health IT Now is reviewing these rules. However, our chief concern is the potential for negative consequences from the ONC final rule. Simply put, the Office of the National Coordinator for Health IT was not created by Congress to be a regulator like the Food and Drug Administration (FDA).
“ONC is clearly overstepping its statutory authority by moving forward with direct review of uncertified functionalities and products, in addition to certified products. By focusing on safety issues, ONC is encroaching on the regulatory functions of other federal agencies like the FDA.
“The FDA, Congress, and other stakeholders have been working for many years to strike an appropriate balance between supporting innovation and regulatory clarity for health IT products. Much progress has been made, with more work needing to be done. This ONC action has the potential to negatively impact those efforts, create confusion in the marketplace, slow innovation, and adversely affect patient safety by impeding access to health IT products.
“Health IT Now urges the White House to reconsider this approach. We also urge Congress to use its authorities to prevent this rule from being implemented, including the withholding of appropriations.
“With regards to the MACRA final rule, we are encouraged by the flexibility included for participants in the programs. Full utilization of technology will be critical to the success of both MIPS and APMs, and we look forward to continuing to work with CMS and Congress to identify opportunities where technology can streamline the programs to work better for providers and patients.”