In its first two weeks in office, the Trump Administration made good on its promise to reduce fiscal burdens on businesses and others trying to comply with federal regulations. This came in the form of three major announcements, including the following:
- An Executive Order issued on January 20th directing federal agencies administering the Affordable Care Act (ACA) to exercise all authority and discretion, to the maximum extent permitted by law, to waive, defer, grant exemptions, from, or delay ACA requirements that impose a fiscal burden on providers, patients, health plans and others.
- A letter from the President’s Chief of Staff, Reince Priebus, to all federal agency directors instructing them to impose a moratorium of 60-days on all regulations scheduled to go into effect, pending review from the new Administration. In that letter, all regulations scheduled to be printed in the Federal Register we instructed to be withdrawn pending further review.
- An Executive Order issued on January 30th directing all federal agencies to identify two or more existing regulations to be repealed when it publishes a new proposed or final rule.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, taken together, must be budget neutral or save the government money.
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. There are significant questions as to the impact of these directives and how much latitude the federal agencies will be able to exercise without violating the Administrative Procedures Act (APA), the law that regulates the process to be used by the federal government when issuing regulations. Regardless of the fiscal burden of some regulations, the agencies will not be able to simply waive notice and comment rulemaking without violating the law. And statutory law cannot be waived through the regulatory process. Because of these ambiguities, the Office of Management and Budget (OMB) is expected to issue additional guidance in the near future on these issues.
These developments will clearly impact the O&P community. For instance, if CMS were to repeal the final rule implementing the definition of “off-the-shelf” orthotics, which greatly expanded OTS orthotics, the definition of that term would revert back to the statutory definition, which states that OTS orthotics include orthoses that are subject to “minimal self-adjustment.” This would significantly reduce the range of orthoses that could be subject to competitive bidding in the future, assuming CMS proceeds with its authority in this area, a very positive development.
Conversely, securing a final rule on Section 427 of the Benefits Improvement and Protection Act of 2000 (BIPA), will likely be more challenging under these new rules. BIPA Section 427 links Medicare payment to qualified practitioner and qualified suppliers and is pending as a proposed rule, comments for which are due on March 13th. These regulatory developments complicate the process to get these regulations issued in final form. NAAOP will be working with its Alliance partners to advance this regulation and will inform our membership as developments occur.