CMS Issues Final Rule on OTS Orthotics

CMS Reverses Fields, Scuttles Current Process for Redefining Orthotics, and for Limiting Scope of Practice for Certified Orthotic Fitters

Late on Friday afternoon, October 31, CMS released the massive final rule covering end stage renal disease payments and a host of other topics, including its proposal to further amend the regulatory definition of “minimal self-adjustment,” and to redefine the Medicare treatment of off-the-shelf and custom fitted orthotic devices.  After receiving voluminous comments which the agency did not address, CMS simply recited a general synopsis of its July 2 proposal, and then announced what appears to be a deferment, at least for the present, on any final action on the orthotics section of the proposed rule.  Of specific importance is the following statement found on page 445 of the final rule:

 At this time, we have decided not to finalize any changes to the definition of minimal self-adjustment in §414.402 to recognize as an individual with specialized training. We may address this provision in future rulemaking.

 You can read the final rule here.

 AOPA is pleased that, at least in the near-term, our efforts in contesting the CMS proposal on OTS orthotics, and further expansion of the terminology of ‘minimal self-adjustment’ have borne fruit.  Not only would the expanded definition violate the statutory definition but it would likely have expanded the number of OTS devices eligible for competitive bidding.  As noted above, CMS released its final rule relating to the larger rule in which the OTS provisions were embedded, but they announced their decision to defer further action as to minimal self-adjustment, and declined to include any decisions dealing with off-the-shelf, or custom-fitted orthotics.  One of the controversial parts of the proposal was a provision that would have limited certified orthotic fitters to patient care services relating ONLY to off-the-shelf orthotics, and that proposed policy now is not poised to move forward in any identifiable time frame. Similarly, the provisions that would have limited provision of custom-fitted devices by unlicensed, and unaccredited providers, and that would have identified physicians, NPs, therapists and certified orthotists as “persons with expertise” in the area of orthotics have also been dropped from any near-term implementation.

Of course, it is left for all of us to speculate on what prompted CMS to reverse fields and not move forward in the direction they had clearly intended just 4 months ago.

 Was it the sheer volume of the 500+ comments from AOPA members AND their patients?

  • Did the recent Grassley-Harkin letter to CMS Administrator Tavenner force top levels in CMS to apply the brakes?
  • Did the O&P Alliance meeting with CMS Chronic Care Director Laurence Wilson on October 21 help shift the tide?
  • Did data from Medicare’s own records analyzed by AOPA’s consultant, Dobson DaVanzo, showing that 19% of Medicare beneficiaries who receive a Medicare-provided OTS orthotic device, also subsequently receive a Medicare custom-fitted device, give pause to the underlying economic principles of CMS action?

We can only speculate, but we have gained, at least, a reprieve.  That is verygood news, and certainly justifies the energies and resources AOPA, its members and patients invested, as well as what the O&P Alliance and others in the profession have expended in opposing deficient parts of this CMS rule making.

AOPA plans to continue to maintain a high alert on these orthotic issues, hopefully leading to a sounder, more lasting treatment of orthotic devices by the Medicare program.

 Any questions regarding this notice can be directed to Joe McTernan at (571) 431-0811 or