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David McGill Blogger

Medicare Proposed Rule Re. "Qualified Practitioners"

Posted by David McGill | January 20, 2017

​​​​Medicare has published a proposed rule that applies specifically to the qualifications required to furnish, fabricate and bill custom-fabricated orthotics and prosthetics. Here are the most important 8 things you need to know about it:

  1. Only qualified suppliers - entities both enrolled with and accredited by Medicare - would be eligible to receive Medicare payment for these items.
  2. Only qualified practitioners would be able to fit these devices. The professionals eligible to become qualified practitioners would be limited to prosthetists, orthotists, physicians, physical therapists, occupational therapists, pedorthists and ocularists.
  3. For any of these professionals to become qualified practitioners in a non-licensure state, they would have to demonstrate that they received specialized training and education, and that they are ABC or BOC-certified. Alternatively, in licensure states, they would have to possess a license in prosthetics, orthotics or pedorthics. 
  4. It would define a custom-fabricated item as one fabricated "based on clinically derived and rectified castings, tracings, measurements and other images such as x-rays of the body part. The fabrication may involve using calculations, templates and components. This process requires the use of basic materials including, but not limited to plastic, metal, leather or cloth in the form of uncut or unshaped sheets, bars or other basic forms and involves substantial work such as vacuum forming, cutting, bending, molding, sewing, drilling, laminating, and finishing prior to fitting on the patient." It also must be constructed using a "positive model technique."
  5. It would require qualified suppliers and practitioners to meet the quality standard and accreditation requirements that they are currently exempt from in order to furnish, fabricate and bill these items. 
  6. It proposes that these devices must be made at a fabrication facility satisfying 38 listed requirements.
  7. If a supplier billed for custom-fabricated orthotics or prosthetics not furnished/fabricated by individuals or entities meeting these standards, Medicare would have the right to revoke the supplier's Medicare enrollment.
  8. It proposes that these requirements would take effect no later than one year after the posting date of the final rule or at the time of the supplier's reaccreditation cycle, whichever is later.

What does this mean for you?

There are myriad issues to discuss in connection with the proposed rule. However, in the interest of brevity, we will focus on three important considerations.

First, virtually everyone would agree that it is a good idea to spell out the specific criteria required to deliver the most complex orthotic devices and prostheses. To the extent that this protects patients from receiving care from unqualified individuals and Medicare from paying them, the publication of the proposed rule is welcome.

Second, your perspective on the qualified practitioner requirements will likely depend on what type of practitioner you are. For anyone already ABC or BOC-certified, the certification and accreditation requirements will generally be viewed positively. However, other health care professionals could take issue with them and weigh in against the proposed rule.

Third, the definition of a "fabrication facility" appears not to distinguish between patient-care facilities and companies that offer central fabrication services. Some of the listed requirements - e.g., the need for parallel bars and patient rooms, just to name two - are not present in central-fabrication facilities for good reason - i.e., those companies do not treat patients themselves. So this is likely to be an area of extensive comment in response to the proposed rule.

We encourage you to read the proposed rule in its entirety, which you can access here. Public comments are due no more than 60 days from January 12th.

We will keep you updated regarding the issues associated with this proposed rule as events warrant.

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