CMS has announced it is withdrawing a proposed rule that would specify the requirements and qualifications needed for O&P practitioners and suppliers, a development that Peter W. Thomas, JD, general counsel for the National Association for the Advancement of Orthotics and Prosthetics, has called a “step backward.”
CMS received more than 5,000 comments on the rule, known as Benefits Improvement and Protection Act (BIPA) Section 427. The strongest criticism of the rule came from physicians, physical therapists (PTs) and occupational therapists (OTs), who “arguably would have been exempted from the rule by statute,” Thomas said in a statement. However, those groups were able to convince HHS to pull the rule, according to the statement.
“The statute itself exempts physicians, and OTs and PTs, from the BIPA section 427, and yet CMS published a proposed rule that would have covered physicians, PTs and OTs,” Thomas said in a YouTube address to members of the NAAOP. “That engendered a tremendous backlash from those communities, and those are powerful organizations.”
Introduced in January, the BIPA Section 427 proposed rule would have required that any practitioner or supplier who provides custom orthotics or prosthetics be licensed, if the state in which they practice has O&P licensure. Otherwise, they must be trained and educated to provide and manage custom O&P care, and be certified by either the American Board for Certification in Orthotics Prosthetics and Pedorthics, the Board of Certification/Accreditation or an accreditation organization approved by the HHS secretary. No payment shall be made by the Medicare program to any practitioner or supplier of custom orthotics or prosthetics who is not qualified to provide an appropriate level of care, according to the rule.
According to Thomas, BIPA Section 427 has been law since 2000, but has never been fully implemented by CMS. Since then, the NAAOP had been working with CMS to regulate and enforce the rule, he added.
When CMS first published the new proposed rule in January, the NAAOP and Thomas called the announcement a “tremendous” milestone.
“This is a broad interpretation of the statutory provision, and it helps us and bolsters some of the arguments that we have been making on related policy issues,” Thomas said in a January 2017 address to NAAOP members. “For instance, it clearly separates further durable medical equipment from O&P care.”
Now, Thomas said the decision by CMS to withdraw the rule is a “step backward.”
“We had viewed this as important to implement over the years, have been frustrated that it has not been fully implemented as of yet and now we’re particularly frustrated that we’re taking a step backward instead of forward,” he said in the YouTube address.
However, Thomas also described what he called some “glimmers of hope.” First, he said CMS announced it had withdrawn the rule to “assure agency flexibility in re-examining the issues and exploring options and alternatives with stakeholders.” Thomas added that the NAAOP has reached out to CMS and plans to meet with officials soon to discuss how to proceed.
Second, Thomas said the decision now places even more importance on the Medicare O&P Improvement Act (S. 1191 and H.R. 2599), which includes provisions compelling CMS to issue regulations interpreting Section 427 of the BIPA. According to Thomas, the bill explicitly exempts physicians, PTs and OTs, which he said should eliminate the main opposition to the previously proposed rule.
The American Orthotic and Prosthetic Association (AOPA) also released a statement expressing disappointment with CMS’ decision to rescind the proposed rule. Although the rule was “far from perfect,” the group said its issues could have been addressed through revision, rather than outright withdrawal.
“AOPA is disappointed that CMS decided to withdraw the proposed rule that would finally create regulations to implement a law that was passed more than 17 years ago,” read a press release from the association. “The withdrawal of the proposed rule once again exposes the Medicare population to no regulation regarding what qualifications are required to provide custom orthotic and prosthetic services.”