NegReg Crashes: Why? O&P's Battle Continues

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By Susi Funkhouser, MBA

The Negotiated Rulemaking (NRM or NegReg) Committee on Special Payment Provisions for Prosthetics and Certain Custom-Fabricated Orthotics participated in nine meetings that totaled 19 days from October 2002 to July 2003, in an effort to reach consensus on rules and regulations for Section 427 of BIPA. On July 14, the NRM Committee members agreed they would be unable to reach consensus and to adjourn the regulatory negotiation and give CMS the responsibility to promulgate these rules consistent with their legislative mandate.

In December of 2000, Congress enacted the Medicare, Medicaid, and SCHIP Benefits Improvement & Protection Act (BIPA 2000), Section 427 of which established a mechanism for the Secretary of the US Department of Health & Human Services (HHS) to utilize negotiated rulemaking procedures to assist in drafting and implementing the rules to be promulgated from the enactment of this new law. This afforded involved parties the opportunity to participate in the identification and resolution of all issues surrounding the regulation, as well as authority to compose the final regulation, via participation in the Negotiated Rulemaking (NRM) process.

Ironically, it was also the language in BIPA 2000, Section 427, that presented the insurmountable hurdles which eventually resulted in the decision that consensus could not be reached and the adjournment of the NRM Committee, thereby turning over responsibility for design and implementation of this regulation to the Centers for Medicare & Medicaid Services (CMS).

Section 427 of BIPA restricts Medicare payment for orthotics and prosthetics, only permitting payment for prosthetics and certain custom-fabricated orthotics when these items are furnished by a "qualified practitioner" and fabricated by a "qualified practitioner or a qualified supplier." In addition, Section 427 describes a "custom-fabricated" orthotic specifically as one that is individually fabricated for the patient over a positive model of the patient. If you would like to review the complete bill text, it can be found at http://thomas.loc.gov/home/c106query.html (You must type in h.r. 5661, which will bring up a table of contents by which you may easily access Section 427.)

Congress sought to involve interested stakeholders in an effort to reach consensus on a proposed regulation that would set forth a list of certain custom-fabricated orthotics that would be furnished by "qualified practitioners" and fabricated by "qualified practitioners" or "qualified suppliers." A lack of consensus on who constitutes a "qualified practitioner" rendered moot the progress that had been made toward consensus on the orthotic codes to be covered under the statute. The issue of "qualified supplier" was largely unexplored as the process broke down over the "qualified practitioner" issue. The meeting minutes and other information regarding these NRM proceedings can be found on the CMS website at http://cms.hhs.gov/faca/prosthetic/

According to Julie Kass, Esq., American Occupational Therapy Association (AOTA), "There were interim issues on which the parties appeared to be moving toward consensus. However, it was established in the Ground Rules' that there could be no partial consensus on individual issues since each participant's willingness to compromise was dependent on the willingness of other parties to compromise on other issues. The definition of consensus was based on the willingness of all parties to live with' the final positions reached by the committee on all issues. AOTA participated in the negotiations in good faith and made clear at all times its commitment to doing its best to reach consensus."

Mike Oros, CPO, alternate representative for POINT Health Centers, elaborates, "Although there may have been a possibility of reaching consensus on certain issues discussed by the committee, the process did not allow for--and because the issues are so intimately related, no one was inclined to accept--piecemeal decisions. There was only opportunity to reach consensus on all the issues as a total package."

The First Hurdle

The first difficulty the Committee faced was the statutory inclusion of the language: "individually fabricated for the patient over a positive model of the patient" in the description of "custom-fabricated." It is a fundamental tenet of statutory construction that an agency must abide by the "plain language" of a statute, which means that where the statute is "plain" or unambiguous on its face, an agency must simply apply the statute as written. This is of concern, because in contrast, as newer custom fabrication techniques have been developed, CMS has removed the words "molded to patient model (MTPM)" from the HCPCS descriptions of most orthotic L-Codes. If this language became the criteria, the list of "custom-fabricated" codes would be far narrower than appropriate from the O&P perspective.

Joel Kaiser, CMS-health insurance specialist, Centers for Medicare Management, summarizes, "The statute specifies that the L-Code list may not contain items that are not individually fabricated over a positive model of the patient. Most O&P experts agree that most custom-fabricated orthoses are made using a positive model. The tentative list we came up with includes all HCPCS codes that have molded to patient model' in their descriptors as well as other custom-fabricated codes that the committee agreed were fabricated using a positive model of the patient. The committee also tentatively agreed that items fabricated directly on the patient, which hold their shape permanently and are not modular, should also be included on the list."

Stuart Kurlander, Esq., National Orthotic Manufac-turers Association (NOMA) representative, comments, "Initially NOMA's position was that only the seven or so codes that include molded to patient model' in the HCPCS description would be covered under the statute. NOMA did modify its position substantially during the negotiations in order to reach consensus with the O&P groups, even extending beyond the terminology of the law itself to add additional orthotic codes beyond the CMS list."

Dennis Clark, CPO, American Academy of Orthotists & Prosthetists (AAOP) representative, elaborates on his perception of the NOMA objective regarding the orthotic services that would be included under the statute: "On one notable occasion NOMA's representative indicated that a drawing and measurements of a patient could not qualify as a model' of a patient and thus would be excluded from the law. For those who were not in attendance, it was NOMA's agenda to show that the vast majority of what they do would fall outside the law and could remain unregulated." NOMA contended that "measurement-based systems" should be excluded, Clark says. "NOMA did, however, indicate that CAD-based models should be included in the law," he continued. "This seemed strange to the O&P organizations as CAD systems are totally measurement-based systems."

PTs/OTs: Qualified To Practice O&P?

Kim Doolan, alternate representative for the Barr Foundation and herself a prosthetic and orthotic user, attended every meeting of the NRM. Doolan describes her emotional reaction to the qualified practitioner negotiations: "I experienced a feeling of shock and awe' as we were bombarded with the repeated claims by APTA/AOTA that they were fully qualified to provide all orthoses and prostheses for all parts of the body. The convener's report cited APTA as performing some of the same services orthotists do, including making or modifying orthotic devices,' and the conveners therefore recommended that to the extent physical therapists are providing custom-fabricated orthotics, they [APTA] should be included. Their transformation--once negotiations began--to claiming that their members are as qualified as an ABC practitioner to provide both comprehensive orthotics as well as prosthetics changed the nature and complexity of the negotiations."

The OT/PT organizations contended that the statutory language contained in other legislation consistently refers to their professionals as "qualified physical therapist" and "qualified occupational therapist" and Section 427 therefore statutorily includes PTs and OTs as automatically "qualified practitioners." AOTA and APTA each pointed out that their licensure and professional standards required that the therapists be competent in any aspect of PT/OT they perform.

"In contrast," details Tony Barr, Barr Foundation representative, "Over 100 letters were generated from licensed PTs and OTs and submitted to CMS and all committee members as exhibits. These letters stated that they had received no specific training in delivering comprehensive O&P and were adamantly opposed to being considered qualified to do so merely because they hold a state license in physical and/or occupational therapy, i.e., licensed' does not mean qualified!'

"In my mind, it brings into question whether the national organizations of APTA and AOTA accurately represent the views of the majority of PT and OT licensed professionals," Barr continued. "The questions of clinical competence may have been able to be more adequately addressed had the credentialing bodies for the PTs and OTs been at the table as were the O&P organizations' credentialing arms. If the conveners detected from their initial interviews that APTA or AOTA would use the NRM Committee to try to legislatively expand their present practice, I would have expected the inclusion of more credentialing expertise."

As John Billock, CPO, FAAOP, and NAAOP representative, explains, "The O&P organizations universally felt that the terms qualified OT' and qualified PT' were used in this legislation to differentiate those OTs and PTs who were qualified to provide prosthetics and certain custom fabricated orthotics' by virtue of specific education and training, not just [by being] licensed--a case in point being the specialized education and training required of an OT/PT to achieve designation as a certified hand therapist."

The O&P organizations therefore were seeking to define what specific education and training should demonstrate competence and be included in this statute's definition of "qualified." Although APTA/AOTA conceded they do not ordinarily provide comprehensive O&P services and practice only within their scope of competency, they were unwilling to confine through regulation their potential to expand their competence to include the complete array of O&P services.

In an effort to gain consensus on this issue, CMS proposed that it would include in the preamble language of the Notice of Proposed Rulemaking (NPRM) a statement indicating that, for the purpose of these regulations, pertinent to Medicare policy, qualified physical therapists and qualified occupational therapists who fabricated definitive prostheses will have additional education and training directly related to the definitive prosthesis for which reimbursement is sought. Additionally CMS will include language that every professional operating under the statute has the responsibility to ensure that he/she is competent to perform the orthotic and prosthetic services provided to an individual patient/client.

The O&P organizations believe they were able to make their point to CMS that PTs and OTs are not clinically competent to provide comprehensive orthotic and prosthetic services by achievement required to receive a state license alone. However, they are genuinely concerned that, given the tendency of CMS to avoid battles over minimum standards and to defer to state standards when possible, there is a threat that CMS will adopt PT/OT state licensure as the standard.

In Tony Barr's opinion, "Several of the participating organizations demonstrated expert political maneuvering in this NRM process. I attended to represent the views of the prosthetic patient and was informed early in the NRM process that prosthetics were off the table.' Based on the perceived lack of inclusion of prosthetics in these discussions, Amputee Coalition of America (ACA) determined it would not participate in the meetings. Suddenly, near the end of negotiations, prosthetic inclusion or exclusion was being leveraged in an attempt to manipulate the O&P organizations to consent that PTs, OTs, and suppliers (represented by APTA, AOTA, and NOMA) were qualified' to provide all orthotic devices without any additional education requirement (i.e., ABC or BOC certification or third pathway as determined by the Secretary of Health). This was disturbing to many who attended since, although competent prosthetic delivery would be better assured by reaching agreement, delivery of quality orthotic care would not be. Oddly, there were no national consumer disability organizations participating in the hearings to safeguard the interests of orthotic patients/end users, i.e. polio, spina bifida, scoliosis, etc. Without being able to resolve the O&P practitioner qualification issue, no attempt was made to further negotiate manufactur-er/supplier qualification criteria, and the meetings were ended without consensus on any issues we were assembled for."

Qualified Supplier' Issues Not Fully Explored

Pursuant to Section 427 BIPA 2000, the term "qualified supplier" means any entity that is: "(aa) accredited by the American Board for Certification in Orthotics and Prosthetics Inc. [ABC], or the Board for Orthotist/Prosthetist Certification [BOC]"; or  "(bb) accredited and approved by a program that the Secretary determines has accreditation and approval standards that are essentially equivalent to those of such Board."

Important issues regarding the qualified supplier (QS) portion of the regulation unfortunately remain inadequately explored. The lack of full discussion by the Committee makes the probable CMS recommendation more uncertain. The O&P community has several concerns. First is the question of whether CMS Supplier Standards are not already the existing law and how this would interrelate with the new regulation? In addition, the statutory QS language in BIPA 427 states that a "qualified supplier" is one that meets the credentialing requirements of ABC, BOC, or other credential deemed similar by the Secretary of HHS. This leaves open the possibility of a third undefined pathway for entities to be a qualified supplier, which O&P participants of the NRM Committee would have liked to have better defined. Kim Doolan explains that "one source of concern in leaving the possibility of a third pathway undefined is that it opens the door to recreate the situations which resulted in the OIG report of 1997, which investigated the incidents of fraud and abuse and initiated the need for Section 427 in the first place. In order to ensure patient protection, the third pathway must necessarily mirror ABC and BOC in requiring specific equipment and dedicated treatment areas, appropriately equipped for patient care and evaluation, supported ambulation, measurement, casting and fitting as well as a specific dedicated laboratory area for servicing, maintaining, adjusting, repairing and/or modifying a custom-designed orthosis and/or prosthesis. Either one of the existing or an additional agency would need to bear responsibility to inspect and accredit these facilities under the third pathway."

In addition, although there was agreement that a qualified practitioner (QP) must oversee the process to allow a facility that fabricates and bills for services under this statute to be designated as "qualified," there was no restriction/limitation placed on either the appropriate geography or volume of services that could legitimately constitute oversight by a single qualified provider. This allows a pathway to provide service without an office, which could result in a patient/end user receiving inadequate clinical support along with their device.

Kim Doolan believes CMS understands the importance of this issue, citing the concern Laurie Feinberg, MD, medical officer, Centers for Medicare Management, expressed to the Committee that it was not only the delivery of the device itself that is of importance, but also the ability to provide follow-up care as well as repairs and adjustments.

Although the "qualified supplier" issue was not fully addressed, NOMA Representative Kurlander comments, "I was optimistic that the issues would be addressed and we could arrive at a consensus position. I felt that through this process, the O&P community arrived at a better understanding of what NOMA was about, and also learned that NOMA appreciates and respects the views of the O&P community and expects to work more collaboratively on issues in the future."

Terry Supan, CPO, FAAOP, representative of the combined State Licensure Boards, expresses skepticism regarding the commonality of the O&P and the NOMA viewpoint: "On the last day, it became evident to me that NOMA's position was going to be that a) their members would not have to comply with any extra qualified supplier' requirements, b) that they could have one qualified practitioner within their company, and c) that they could bill for an orthosis that was delivered by a sales representative in a qualified practitioner's office, again without having to comply with any extra qualified supplier' standards. None of those points were acceptable to the orthotists and prosthetists on the committee."

Several O&P representatives expressed concern about the APTA efforts in the final stages of the NRM process. These efforts resulted in a letter written by Congressman Billy Tauzin (R-LA) to CMS Administrator Tom Scully, requesting they introduce no language at a federal level that contradicts some state language that specifies in certain states, "licensed PT" is equal to "qualified PT." There was also concern about APTA's attempt to capitalize on language of the Senator Blanche Lincoln (D-AR) amendment to the proposed Medicare Reform Bill currently being addressed in Congress, which, according to AOPA, would:

1. Assert that a "qualified physical therapist" is one that is state-licensed. This provision would circumvent the current NRM process and negate the position that PTs need specific O&P education to be able to provide O&P services. If this amendment passes, CMS would be forced to equate "qualified physical therapist" with state licensure.

2. Establish a Medicare demonstration project that would permit PTs to prescribe and provide O&P care without a physician's prescription. In essence, PTs would be able to refer patients to themselves and provide O&P services without making a referral to an O&P practitioner.

Kurlander commented, "I was disappointed that the Committee failed to reach consensus and wanted to keep working. From NOMA's point of view, the issues were substantially settled, and I believe we could have found common ground on the outstanding issues. Given the resources in time and money each participant organization invested in the process, it was unfortunate that the Committee reached deadlock." Regarding next steps for the involved organizations, Kurlander summarizes, "NOMA expects that we and every other interested organization will reevaluate their positions taken during the NRM, now that the negotiation process has proven unsuccessful."

Other organizations involved in NRM also express their disappointment. "AOTA finds it regrettable that the committee was not able to reach consensus," says Kass. "From the outset, it was a key principle that consensus could not be reached without the willingness of 100 percent of the participants to refrain from negative comment on a regulation that would be consistent with the consensus. It was not necessary that each participant fully support each aspect of the total agreement. Rather, each party had to be able to live with the consensus as a whole. From the beginning the parties were told that no party would succeed on all of its issues.

"Even though consensus was not reached, we believe there was benefit to the process for CMS because it gained useful insight into the positions of the participants and the bases for those positions," Kass continues. "CMS will certainly be able to use the knowledge it acquired to promulgate the proposed rule.

"We cannot predict what course of action CMS will take," Kass says. "We believe, however, that CMS will act fairly, based on the requirements of the statute, and that it will promulgate a regulation on its own. By failing to reach consensus, the group gave up an opportunity to ensure that the proposed regulation would likely be consistent with the collective views of the participants."

Supan felt that the staff members from CMS had a good understanding of the patient care and education issues raised by the O&P professionals and the physicians. "I feel the CMS staff will be capable to create rules that are based on established educational standards and professional competency and not any outside issues like direct access to therapy."

Clark summarizes the cumulative position of the O&P organizations this way: "These NRM sessions were set forth to attempt to stop the unregulated provision of O&P services to Medicare beneficiaries and to attempt to pre-qualify providers in order to ensure that the services being paid for with federal monies would be worthy of both the beneficiaries and the dollars being spent. While the O&P organizations came to the meeting with the understanding that their task should include patient protection,' the legal representatives from the OT/PT associations and NOMA had a completely different agenda--turf protection.' I firmly believe each O&P representative came to the table understanding that we had both a professional obligation to our Medicare clients and a fiduciary/stewardship responsibility to CMS. In the end there was no consensus reached, but I don't look at this as a failure. The appointed representatives worked hard to educate the panel members and CMS and articulated with both grace and force our positions.

"In the end I was more proud of the profession I have chosen and the men and women who share our commitment to serve both patient and payer with efficacy, efficiency, and honesty," Clark continued. "The line that comes to mind is, To thy self be true.' And we were."

The Committee members worked very hard and with the best intentions. However, the issues were simply too complex to be resolved by this process. The non-consensus agreement signed by all NRM Committee members at the final NRM meeting included the specification that "all members of the Committee shall have the right to submit a final statement to CMS that will become part of the record, as long as such document is received no later than August 31, 2003."

Each organization involved in the NRM Committee was invited to participate in this article. At press time, those organizations not quoted were either unable to be reached or declined comment.