NAAOP: Trump’s orders could mean a ‘more complex’ regulatory process

The National Association for the Advancement of Orthotics and Prosthetics has released a statement on three recent actions taken by President Donald J. Trump’s administration.

“There are significant upsides and downsides to these three initiatives, but one thing is clear; the regulatory process will be much more complex in the future,” David McGill, JD, president of the National Association for the Advancement of Orthotics and Prosthetics (NAAOP), said in a press release.

According to the release, the three actions include:

  • an executive order issued on Jan. 20, which directs federal agencies that administer the Affordable Care Act (ACA) to exercise authority to the maximum extent permitted by law to waive, defer and grant exemptions, from, or delay ACA requirements that impose a fiscal burden on providers, patients, health plans and others;
  • a letter from Chief of Staff Reince Priebus to all federal agency directors that instructs them to impose a 60-day moratorium on all regulations scheduled to go into effect, pending review from the new administration; and
  • an executive order issued on Jan. 30 that directs all federal agencies to identify two or more existing regulations to be repealed when it publishes a new proposed or final rule. The net cost of these regulations must be budget-neutral or save the government money.

According to the release, it remains unclear how these directives will affect the way federal agencies operate in conjunction with the Administrative Procedures Act, a law that regulates the process to be used by the federal government when issuing regulations.

“These developments will clearly impact the O&P community,” McGill said in the release. “For instance, if CMS were to repeal the final rule implementing the definition of ‘off-the-shelf’ (OTS) orthotics, which greatly expanded OTS orthotics, the definition of that term would revert to the statutory definition, which states that OTS orthotics include orthoses that are subject to ‘minimal self-adjustment.’”

This could significantly reduce the range of orthoses subject to competitive bidding in the future, the release noted, adding that it is a “positive development.”

“Conversely, securing a final rule on Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA), will likely be challenging under these new rules,” McGill said. “BIPA Section 427 links Medicare payment to qualified practitioner and qualified suppliers and is pending as a proposed rule, comments for which are due March 13.”

“There has been a tremendous amount of regulatory activity in the first 2 weeks of the Trump administration and it does impact orthotics [and] prosthetics, Medicare and the Affordable Care Act,” Peter W. Thomas, JD, NAAOP general counsel, said in a corresponding YouTube video. “The Office of Management and Budget is expected to issue additional details on these regulatory changes, and we will be sure to bring them to your attention as soon as they become publicly available.”



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