AOPA’s Response to CMS Proposed Physician Template for Lower Limb Prostheses


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May 23, 2013

Marilyn Tavenner
Administrator Centers for Medicare & Medicaid Services
Mail Stop 314G
200 Independence Ave, SW
Washington, DC 20201Dear Administrator Tavenner,

I learned through a second-hand source that CMS had published on May 7, on its website, the outline of proposed components of a template form for prosthetics. That was the day before our last meeting with you, on May 8, so I am surprised that this publication did not come up in our conversation then. I wanted to give you some feedback, and unfortunately, I must report that this template, far from being a step forward, is instead a clear example of a severe lack of understanding of how prosthetic care is delivered to Medicare beneficiaries and is likely to compound the problem we seek to solve.

We expected that any template would be published through a rulemaking, rather than through an obscure website notice. Moreover, when we spoke on May 8, you spoke in favor of a template for prosthetics, maintaining that this, perhaps in conjunction with pre-authorization, could eliminate any need for RAC audits, and that the template could be completed by the prosthetist and potentially signed off on my the physician. Although such a template would not cure the improper conduct identified in our recently-filed complaint, it potentially could be part of a comprehensive settlement. Sadly, the document CMS staffers posted on your website the day before that meeting is nowhere close to what you described. The template the agency has published, even if a ‘work in progress’, is incompatible with the Administrator’s promise that it would be capable of being completed by the prosthetist and is of such great specificity that very few, if any, physicians would provide such extensive detail. In short, the template is simply unworkable.

Putting aside CMS’ improper insistence on physician documentation, CMS can’t seem to understand:

DME is very different from O&P, and

that medical necessity for artificial limbs is very different from power mobility equipment.

If a person is an amputee, the need for an artificial limb is pretty obviously a medical necessity. I fear that we can never make any progress toward solving the present problem so long as agency personnel want to re-tread purported solutions for power wheelchair over-utilization to the completely different and unrelated world of artificial limbs—to try to force prosthetics/artifical limbs into a DME/PME box. The analogy is flat out wrong, and the attempted “one size fits all” solution is inexorably destined to fail, and make matters even worse, as impossible as that may seem.

In a recent letter to your colleague George Mills, we underscored the perilous course CMS contractors are following in using physician records to try to rebut, overturn and invalidate from afar and without ever having examined, or having had any other contact with the patient, the professional decision and prognosis of that patient’s physician. AOPA wrote:

“Even more disturbing than what Jurisdiction B has said, is what they have started to do. Specifically, we are aware of claims in which Jurisdiction B claims reviewers have been using details of the patient’s health that are unrelated to their amputation or limb loss. These factors include the use of hypertensive medications to treat blood pressure, history of cancer treatment, history of peripheral vascular disease, body weight conclusions derived from scrutiny of every factor in the patient’s medical record. Claims reviewers are relying on these factors as the basis for overturning the comprehensive K-level determination. Taking isolated facts about a particular patient’s medical history out context and without the ability to directly engage the patient and then rendering a decision is venturing into dangerous territory. Claims reviewers are rejecting the determination made by trained professionals who have actually examined the patient, and substituting a lower K-level determination, even though the claims reviewer has never even seen the patient and often has little if any experience in prosthetics or the care of amputee patients.

AOPA believes that this type of contractor activity is totally inappropriate and represents a modification of the standard of care for Medicare beneficiaries. It further is an inappropriate misuse of contractor access to physician documentation as well as possible interference with the practice of medicine. Moreover, it creates new, inappropriate and unfair impediments that discourage claims, regardless of merit, involving the more advanced (and therefore more expensive) technologies for prosthetic feet. This activity seeking to ‘downshift’ the standard of care of these Medicare amputee beneficiaries to a new, lower level emphasizing a shift to less advanced (less expensive) technologies—occurs in a manner which discriminates, and operates to the detriment of amputees, i.e., disabled persons as defined by the American for Disabilities Act.”

Mr. Mills’ response largely ignored this problem, simply asserting that:

“Your letter then contends that the contractor should not be taking overall health status into consideration as they evaluate medical record information. While you previously agreed that the physician must use all of his or her diagnostic skill and medical training that would, by necessity, include the beneficiary’s past medical history and illnesses, you then criticize Jurisdiction B medical review staff for attempting to conduct claim review in a similar manner. Your letter states:

‘Specifically, we are aware of claims in which Jurisdiction B claim reviewers have been using details of the patient’s health that are unrelated to their amputation or limb loss. These factors include the use of hypertensive medications to treat blood pressure, history of cancer treatment, history of peripheral vascular disease, body weight conclusions derived from scrutiny of every factor in the patient’s medical record.’

As you know, there are many factors other than the physical loss of a limb that impact a beneficiary’s ability to function. It is entirely appropriate for medical claim reviewers to evaluate documentation concerning co-morbid conditions when such conditions could reasonably be expected to impact a beneficiary’s overall functional ability when making reasonable and necessary determinations. For example, a beneficiary with Class IV heart failure as a result of their hypertension is not likely to improve with a limb amputation such that they are now a K-3 level ambulatory. The ordering physician’s medical documentation must support the K-level determination they themselves make. Reviewers are neither altering these determinations nor affecting the standard of care in any way. Reviewers only confirm whether or not submitted documentation is sufficiently supportive.”

Sadly, the template published on the CMS website is further evidence that CMS and its contractors think somehow this type of backbench umpiring is appropriate for Medicare and for the care of the beneficiaries whose health and mobility is entrusted to the Medicare program.

In conclusion, even though AOPA continues to maintain that simply dropping information on the CMS website does not in any way satisfy CMS’ administrative law responsibilities to all stakeholders, once having stumbled upon this item (and alerted many others in the O&P field to its existence), we did not want to let the occasion pass without conveying our views on it generally, and how this document is incompatible both with the kind of possible partial solution you outlined in our meeting on May 8, and with finding a pathway to better care for Medicare amputees and fair treatment of the prosthetic and orthotic health professionals who provide that care. These problems need solutions, but neither this template nor the ‘warmed over’ PME pre-authorization concept does anything to advance in that direction.

Very truly yours,

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Thomas F. Fise Executive Director