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O&P Negotiated Rulemaking Update

The Benefits Improvement and Protection Act of 2000, Section 427, required the Centers for Medicare and Medicaid Services (CMS) to form a Negotiated Rulemaking Committee ("the Committee") for the establishment of standards relating to billing Medicare for orthotics and prosthetics ("O&P"). Recently, the Convener's Findings and Recommendations Report ("the Report") was sent to the Centers for Medicare and Medicaid Services ("CMS") for the upcoming negotiated rulemaking process required by BIPA Section 427. The Report was submitted by the Conveners of the Federal Mediation and Conciliation Service, Lynn Sylvester and Ira B. Lobel.

The Report predicts that the first meeting of the Committee will not take place until early next year. CMS is required to publish a notice in the Federal Register of the dates, times, and locations of all meetings of the Committee. Even if a group or organization is not ultimately chosen to participate in the negotiated rulemaking process as a Committee member, they nonetheless are permitted to attend all meetings.

CMS is currently preparing a formal notice, to be published in the Federal Register, to announce the formation of the Committee that will participate in the rulemaking process. It is anticipated that this notice may be published in early November. The Report submitted to CMS lists a number of proposed participants (listed below) who have been identified as potential participants in the rulemaking process, including the National Association for the Advancement of Orthotics and Prosthetics (NAAOP).

The Report indicates that there are five broad issue areas that the Committee will likely address during the rulemaking process: 1) What and who should be covered by the rule; 2) The certification, credentialing, and licensure of O&P practitioners; 3) Program management; 4) Special needs areas, such as rural areas; and 5) Program implementation issues. Included within the first of these issue areas is the statutory definition of the phrase "individually fabricated for the patient over a positive model of the patient," and how this definition will fit into the overall context of coverage decisions and policies.

Decisions by the Committee during the negotiated rulemaking process will likely be made based upon a consensus process. Consequently, the potential members of the Committee were not identified and chosen with a view toward ensuring that a precise balance of viewpoints among the competing views of the various certification bodies should be achieved as part of the rulemaking process. Rather, in selecting potential participants of the Committee, the conveners identified a broad spectrum of interest groups within the overall O&P community. These groups may be summarized as encompassing seven areas: 1) certifying organizations; 2) research and education organizations; 3) educational and membership organizations representing practitioners; 4) general industry and business organizations; 5) Medicare beneficiaries; 6) state entities; and 7) a "miscellaneous" category.

A major point of agreement that was discovered by the Conveners in their efforts to identify potential members of the Committee was that there must be a "common thread of experience and education" among O&P practitioners upon which consumers can rely. Potential participants were chosen with a view toward obtaining an appropriate mix of interests and a variety of concerns. Although the Charter establishing the creation of the Committee allows for up to twenty members of the Committee, the Conveners are attempting to keep that number to approximately fifteen Committee members. Pursuant to the provisions of the Negotiated Rulemaking and Federal Advisory Committee Acts, the Committee is required to operate under an agreed-upon set of guidelines that will govern its work throughout the negotiated rulemaking process.

The following groups and organizations have been identified by the Conveners and have been recommended to CMS to serve as members of the Committee during the rulemaking process:

  • American Board for Certification in Orthotics and Prosthetics (ABC)

  • Board for Orthotist Prothetist Certification (BOC)

  • National Community Pharmacy (NCP)

  • National Commission of Orthotic and Prosthetic Education (NCOPE)

  • American Academy of Orthotists and Prosthetists (AAOP)

  • National Association for the Advancement of Orthotists and Prosthetists (NAAOP)

  • American Physical Therapy Association (APTA)

  • American Orthotic and Prosthetic Association (AOPA)

  • National Orthotic Manufacturers Association (NOMA)

  • International Association of Orthotics and Prosthetics (IAOP)

  • Hanger Prosthetics

  • Point Health Centers

  • Coalition of Illinois and Florida certification boards

  • Coalition of state associations representing orthotists and prothetists

  • Paralyzed Veterans of America (PVA)

  • National Association for Long Term Care (NALTC)

NAAOP will continue to closely monitor the negotiated rulemaking activities

for the establishment of federal standards governing the billing and certification of O&P products and will keep its members and the entire O&P community abreast of these important developments as they occur.

Prepared by Peter W. Thomas, General Counsel, and Jeremy Allen, Legislative Director

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