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Re: Comments to Draft Medicare Knee Orthoses Medical Policy

Medical Director

DMERC Region A

TriCenturion, LLC

P.O. Box 100282

Mail Code ZA-190

Columbia, SC 29202-3282Adrian Oleck, MD

Medical Director

DMERC Region B

Adminastar Federal

8115 Knue Road

Mail Point AF10

Indianapolis, IN 46250Stacey V. Brennan, MD

Medical Director

DMERC Region C

Palmetto GBA

P.O. Box 100141

Mail Code AG-250

Columbia, SC 29202Robert D. Hoover, Jr., MD

Medical Director

DMERC Region D

CIGNA HealthCare

Metro Exchange Building

2 Vantage Way

Nashville, TN 37228

Dear DMERC Medical Directors:

These comments are sent in response to the four Durable Medical Equipment Regional Carriers’ (DMERCs) coordinated publication in draft form of the new medical policy for knee orthoses covered by the Medicare program.

Let us begin by thanking you for your decision in January 2004 to rescind the “policy clarification” that attempted to prohibit the use of add-on HCPCS codes in conjunction with base codes for orthoses that are described as “prefabricated.” NAAOP strongly disagreed with this policy clarification and submitted comments to that effect to the SADMERC and all four DMERC Medical Directors. NAAOP is grateful for your willingness to consider our views and to take steps to accommodate our concerns accordingly.

It is for this reason that NAAOP was so disappointed to read the new draft DMERC medical policy on knee orthoses. Not only is the same inappropriate and unsupported add-on code issue being proposed again, but a number of other very troubling proposals have been included in this draft in which NAAOP is forced, once again, to take exception. This new policy, if finalized in current form, will adversely impact practitioners and the Medicare program, and will deprive patients of necessary options that enhance the comfort, stability, and, most-importantly, function of knee orthoses. As we witnessed with the policy clarification in December 2003, this new policy is contrary to the history and fundamental nature of the L Code system and, we believe, should not be implemented without substantial revision.

There are a number of trends that concern NAAOP greatly with respect to the provision of Medicare-covered orthoses. First, The SADMERC and DMERC Medical Directors appear to be willing to grant orthotic practitioners less and less deference and recognition as health care professionals. Instead, they are more likely to view those who provide orthoses to Medicare beneficiaries as suppliers akin to salemen of off-the-shelf items, despite the complexity and wide range of orthoses provided to Medicare patients today. This approach devalues the high accreditation standards in the orthotic profession and undermines the importance of the thorough education and residency requirements necessary to become certified. This, in turn, opens the practice up to opportunistic behavior from other providers and suppliers, as well as non-professional “salespeople,” who boldly assert that they are just as qualified to provide comprehensive orthotic care as the orthotists who have devoted their lives and livelihoods to the orthotic profession. The ultimate result is a diminution in the quality of patient care.

Second, the first trend seems to emanate almost entirely from often legitimate concerns about overutilization and fraud and abuse generally. But as we have just suggested, the lack of recognition for professional orthotic care is, in part, responsible for the increasing number of providers and suppliers-who lack sufficient training and experience in orthotic care-billing an ever-increasing number of orthoses to patients. In our view, the answer to many of the controversial issues raised by the draft knee orthosis medical policy lies in treating orthotics as truly separate and distinct from durable medical equipment and developing medical policy that recognizes that quality orthotic care is as much a professional, clinical service as it is the provision of an orthoses.

This recognition is most effectively accomplished through certification of orthotists and accreditation of orthotic facilities. There are professional orthotic and prosthetic credentialing organizations and educational accreditation programs in place to provide guidance to CMS and the DMERCs as to whom should be considered a qualified supplier of orthotic and prosthetic care. CMS should accept the education and training criteria embraced by the American Medical Association in 1992 to be declarative of orthotics and prosthetics being allied health professions. In addition, standards have been established by the American Board for Certification in Orthotics and Prosthetics (ABC) and the Board for Orthotist/Prosthetist Certification (BOC) which currently administer psychometrically sound credentialing examinations for both orthotics and prosthetics.

NAAOP strongly supports the government’s efforts to tackle fraud and abuse and the DMERC’s use of post-payment audits is certainly one avenue to achieve results. But the Medicare program must also recognize the demographics of the Medicare population and the increased prevalence of conditions such as diabetes, obesity, and other chronic diseases and disabilities that will continue to build demand for orthotic intervention.

Pursuing the laudable goal of decreasing inappropriate utilization should not translate into the implementation of medical policy that fundamentally changes the quality of orthotic care available to Medicare beneficiaries. The risk of overutilization of orthoses can clearly be addressed without sacrificing access to, and the safety of, professional orthotic clinical care and related orthotic technology.

Unfortunately, the current draft knee orthoses medical policy implicitly rejects a more focused response to the risk of overutilization and, instead, proposes sweeping changes to the entire L code system that, in our view, are inappropriate and potentially harmful to patients. The current draft seems to be less a medical policy based on clinical studies and sound medical practice and more a rationing policy that employs a “least common denominator’ approach, all with the intention of limiting Medicare expenditures for orthoses with little recognition of the impact on patient care.

Attached please find NAAOP’s specific comments to various sections of the draft Local Coverage Determination as well as comments to the draft “Policy Article.” Our comments are inserted directly into the existing draft medical policy and policy article for ease of review. But our overall concerns can be summarized into six basic points, five substantive and one procedural in nature.

1. Replacement of the Term “Custom Fitted” with the Term “Prefabricated”

The draft knee orthoses medical review policy continues the alarming trend that began several years ago where the SADMERC and DMERCs have been systematically phasing out the term “custom fitted” from the L-code descriptors and medical policies for orthoses, and replacing this term with the word “prefabricated.” The end result of this approach is that a whole sector of relatively complex orthotic treatments have been relegated to being viewed as “off-the-shelf” orthoses that require minimal professional training to provide to patients.

This inappropriate designation simply does not reflect the level of professional knowledge and skill that is often required to adequately assess the patient and provide appropriate orthotic care. This policy trend has set the stage for the Medicare program to treat these orthoses like durable medical equipment is treated. Some examples include periodic rebasing of reimbursement rates for groups of these devices (seemingly without legal authority to do so), the requirement to first provide prefabricated orthoses before providing custom orthotic treatment, and application to competitive bidding.

2. Requiring Fitting of a Prefabricated Orthosis First

The requirement in this draft policy-which has also appeared in prior DMERC orthotic medical policies-that orthotists must first attempt to fit the patient with a prefabricated orthosis before designing, fabricating and fitting a custom orthosis continues to potentially place Medicare beneficiaries in harm’s way. This policy again underscores the DMERC’s lack of recognition for the professional, clinical service that is integral to quality orthotic care. The standard that should determine whether a prefabricated orthosis or custom fabricated orthosis will address the unique circumstances of the patient is medical necessity.

The preference for prefabricated orthoses-rather than relying on the physician and orthotist to determine the optimal treatment plan-that the DMERCs are building into the Medicare orthotic benefit invites minimally trained and largely unqualified suppliers to attempt to meet the needs of Medicare patients through trial and error. For these reasons, NAAOP strongly urges the DMERCs to eliminate this blanket policy from this draft and all other orthotic policies that employ this preference for prefabricated orthoses and work together to develop an alternative that better meets the needs of the government, beneficiaries and the orthotists who serve them.

3. Prohibiting Practitioners from Billing Add-on Codes with Prefabricated Codes

Unlike most HCPCS codes, in which a single code is meant to globally cover an entire procedure or item, L codes have always been divided into “base” codes and “add-on” codes that a practitioner combines, when appropriate, in order to represent the unique functionality and components of a prosthesis or orthosis. There is no precedent for introducing a third category of L codes; base codes that cannot be used in conjunction with add-on codes. There is simply insufficient support for the prohibition on the use of add-on codes in conjunction with base codes for orthoses that are described as “prefabricated.” However, in instances where a particular add-on code is clearly inappropriate to be billed with a base orthotic code, the DMERC claims process should and, in fact, does edit these codes out for denial of payment.

Notwithstanding instances where inappropriate add-on codes are edited out of Medicare claims, there are a number of examples in clinical practice where orthoses described as “prefabricated” require the addition of appropriate add-on codes for individual patient needs. The point of the L code system’s add-on codes is to not deconstruct braces for additional payment, but to assure that a physician and orthotist can uniquely tailor the care that is needed. It is impossible to know ahead of time what care (and add-ons) may be necessary for the unique needs of the patient. A special removable silicone liner(s) for burn patients or a special knee cap for comfortable 3-point leverage for a patient with a dislocated patella are examples of this important point.

The draft knee orthosis policy restricts practitioners from providing necessary services, ultimately depriving patients of proper medical treatment. This new policy will have one of three impacts. It will either:

  1. force practitioners to rely more often on more costly custom-fabricated orthoses, even when a prefabricated orthosis with add-on features could be used;

  2. cause practitioners to provide prefabricated orthoses without making medically appropriate additions to the orthoses, because such additions are no longer reimbursable; or

  3. shift additional costs onto practitioners who will feel compelled to provide the additional add-on features despite the lack of additional reimbursement. Thus, this rule will be highly detrimental to practitioners, the Medicare program generally, and the quality of patient care.

Furthermore, since the inception of the L Code system, the fee schedule amounts for L codes are based on the assumption that base codes will be submitted in conjunction with appropriate add-on codes. Accordingly, the reimbursement for a base code is often set lower than if the item were to be furnished on a stand-alone basis. By prohibiting the combination of prefabricated orthoses codes and add-on codes, this policy will result in inappropriately low reimbursement for many orthoses, inadequately reimbursing practitioners for the cost of furnishing orthotic care.

4. Add-on Codes Should Not Be “Folded” into Existing Base Codes

NAAOP opposes the draft policy that seeks to incorporate certain features represented by separate add-on codes into a base code, without a corresponding rebasing of the reimbursement level for the base code. This proposal apparently stems from data that suggests that with certain base codes, a similar set of add-on codes are often simultaneously billed to the Medicare program. This new policy would set a precedent that fundamentally alters the very nature of the orthotic billing code system and, in our view, the DMERCs do not have this authority. It would also create a circumstance where the Medicare program would be paying for a set of features (formerly represented by separate add-on codes) that the patient may not require or receive due medical contraindications or other reasons.

5. Restricting Base Codes for Specific Diagnoses

The draft knee orthosis policy also proposes to restrict certain base codes to patients with specific diagnoses. To our knowledge, this is an unprecedented proposal. NAAOP strongly opposes this portion of the draft policy and urges the DMERCs to reconsider it because it artificially restricts physicians and orthotists in their orthotic treatment options. Again, the test should not be whether a particular course of orthotic treatment meets a preconceived notion of what it is capable of achieving. The test should be whether the particular treatment chosen by the physician and qualified orthotist is medically necessary for the patient in question.

6. The Draft Medical Policy on Knee Orthoses Represents a Substantive Change to National Policy and, Therefore, Requires Notice-And-Comment Rulemaking Pursuant to the Administrative Procedure Act.

The Administrative Procedure Act (APA) requires all federal agencies to publish proposed rules in the Federal Register in order to provide the public with notice and an opportunity to comment. 5 U.S.C. § 553(b) and (c). The SADMERC and DMERCs, acting in concert by issuing this draft policy at the exact same time and in the same form from one DMERC to another are, in effect, taking the place of CMS and are creating de facto national policy. This essentially circumvents the APA’s “notice-and-comment” requirement that calls for publication of the draft policy in the Federal Register. 5 U.S.C. § 553(b). Accordingly, we believe that the SADMERC and DMERCs are not permitted to make the kind of substantive changes that are proposed in the knee orthoses medical policy without adhering to the requirements of the APA.

While there is an exception to the APA notice-and-comment requirement for “interpretive rules,” 5 U.S.C. §553(b)(3)(A), this exception should not be applicable to this draft policy. Though the line between substantive rules and interpretative rules is not always clear, “[i]f a rule creates rights, assigns duties, or imposes obligations, the basic tenor of which is not already outlined in the law itself, then it is substantive.” La Casa Del Convaleciente v. Sullivan, 965 F.2d 1175, 1178 (1st Cir. 1992).

The DMERCs’ draft knee orthoses medical policy represents a fundamental and substantive change to the L code system. It will result in the denial of coverage of add-on orthotic features and a whole host of other orthotic treatments that are routinely covered today after consultation between the physician, orthotist and patient determines the medical necessity of a particular course of orthotic care. Accordingly, the change in medical policy is a substantive rule, not an interpretation of existing policy. It should, therefore, be subject to the APA’s notice-and-comment requirements and the failure to satisfy these requirements leaves it open to challenge.

For the reasons discussed above, we believe that the draft knee orthoses medical policy should be substantially revised before being implemented. Again, we appreciate the opportunity to offer our views and thank you for your willingness to consider them. If you would like to discuss these issues directly, please call me at (432) 683-3788.

Sincerely, Michael J. Allen, CPO, FAAOP President, NAAOP.

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