NegReg: NOMA at Work

By Judith Otto

In case you arrived at the party late, let's review: Encouraged by the American Orthotic and Prosthetic Association (AOPA) and prompted by laudable motives, in 2000 Senator Tom Harkin (D-IA) drafted a bill that would require those who fit prostheses and "certain custom orthoses" to be "qualified."

Since the definition of "qualified" can vary substantially, depending on your viewpoint and the size of your investment, the US Secretary of Health and Human Services (HHS) was charged with creating a more specific definition.

Since Secretary Tommy Thompson recognizes the need for expert advice and assistance in arriving at such a definition, his conveners are forming an advisory panel-a Negotiated Rulemaking (NegReg) Committee-comprising various groups and organizations with a professional and/or personal interest in the practice of orthotics and prosthetics.

Who qualifies for the committee, and why?

Commissioners Lynn Sylvester and Ira B. Lobel of the Federal Mediation and Conciliation Service discussed the answer with The O&P EDGE:

The statute automatically includes the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board for Orthotist Prosthetist Certification (BOC) and specifically refers to including manufacturers, said Sylvester, answering the question of how the National Orthotic Manufacturers Association (NOMA) gained a seat on a committee whose primary purpose is to address standards for the fitting of "prosthetics and certain custom orthotics."

"NOMA, as discussed in the convener's report, is a small group of manufacturers who manufacture orthotic products. They were one of the groups I talked to, since there was some reference to manufacturers in the statute," she explained.

What the NegReg Act seeks to do is to create a broad-based committee, so that all of the affected interests are represented at the negotiation table. Sylvester explained, "What kind of makes this tough is that there are always more people participating than we have seats. The NegReg Act allows a maximum of about 25.

"We try to involve those who represent various stages of the process," Lobel added. "Since it takes training to make, fit, and use the devices, we're looking for representation from all three of those areas. Manufacturers have concerns and should be represented."

NOMA declined to answer questions about its objectives in serving on the NegReg committee, but Morris Gallo, CPO, who was appointed by the Florida O&P Licensure Board, reported that NOMA recently sent a letter to the Florida Board requesting a declaratory opinion, noting that its members are highly qualified and should be exempt from licensure.

Eddie Rogers, executive director of the California Orthotic and Prosthetic Association (COPA), further confirmed that NOMA's efforts had contributed significantly to the failure of licensure legislation to pass in that state. He pointed out that NOMA manufacturers sell hardware to orthopedic surgeons-from hips, knees, and similar internal components, to related DME items-ice packs, continuous motion machines, etc. "They make money by serving as full-service providers," said Rogers. "Post-operative bracing is an important part of their package. Unfortunately, they are trained to sell rather than to fit patients. Once the patient is fitted, they have no means of providing necessary follow-up service. Patients should be assured of quality care on an ongoing basis."

Rogers also noted that NOMA's arguments to the California legislature were in support of the absence of any standards for fitting orthotic patients. These arguments were justified by claims that there were no patient complaints and that doctors wanted them to maintain the status quo-claims that Rogers plans to refute in future attempts to pass licensure in his state.

Some feel that even AOPA may face some ticklish issues speaking from its committee seat: how can one represent the wishes of a membership whose interests and opinions vary so widely? AOPA's official response to our questions was cautiously conservative: "AOPA has put together an advisory group of well-respected members of the field who will provide input and guidance to the association as we progress through the rulemaking process. Our goal is to ensure that orthotic and prosthetic patients receive appropriate care from qualified providers. Any outcome that achieves this goal will be considered a success."

Adequate consumer representation on the NegReg Committee has been a concern. For comments from involved individuals and organizations, please read " NegReg: Are Consumers Adequately Represented? ".

So what can we look for as this continuing drama unfolds (in addition to suspenseful entertainment, of course)?

"All these various groups at odds with each other, thrust into a room, and expected to come up with appropriate verbiage-," Gallo mused. "The outcome will depend on who's most persuasive. Secretary of Health Thompson will make the ultimate determination, based on what he hears. So it will all boil down to who talks best and loudest."

In the long run, it may be a moot issue after all. If all states eventually pass their own licensure laws, federal laws will be irrelevant. "State licensure laws will take precedence over whatever federal legislation is finally clarified," said Gallo.

"It's a basic part of states' rights to regulate their own professions." Tony Barr of the Barr Foundation agreed, pointing out that passing licensure laws in all states is the key to getting proper coverage for amputee patients. "The current lack of regulation is the reason third-party payers are pulling back," Barr said. Since demand for O&P services is rapidly exceeding the supply, Barr admitted that it may be necessary to lower standards slightly. "But to have none is ludicrous." He asks, "Are we going to significantly compromise the safety of the patient-and further discourage proper coverage by third-party payers-by lowering previously set standards in order to accommodate the increasing demand for these services?"

Barr suggests that it is past time to bury the hatchet between organizations participating in the "alphabet soup wars" over credentialing.

"What's good for consumers is good for the profession. It's that simple," he said.

Judith Otto is a freelance writer based in Holly Springs, Mississippi.

Updated list of NegReg Committee participants .