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CMS Proposes New Coverage Criteria for DMEPOS

In the proposed physician fee schedule for federal fiscal year 2005, the Centers for Medicare and Medicaid Services (CMS) published proposed coverage criteria for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). If finalized in their current form, these coverage criteria will impose additional requirements on Medicare coverage of orthotic and prosthetic services.

The proposed regulations are in response to the Medicare Modernization Act (MMA) that was enacted at the end of last year. As part of an effort to improve quality and reduce fraud, section 302(a)(2) of the MMA requires CMS to establish regulatory standards governing the coverage of durable medical equipment. Of note, the statutory language does not instruct CMS to create these standards for orthotic or prosthetic services. Additionally, the MMA states that CMS’s standards should specify the “types or classes” of DME that require a face-to-face examination with a physician (or certain other practitioners) and that CMS should first establish standards for types of DME where there has been “a proliferation of use, consistent findings of charges for covered items that are not delivered, or consistent findings of falsification of documentation.”

Despite the language of the MMA, CMS proposes to apply these regulations to all DMEPOS, not just DME. Additionally, the agency has chosen not to prioritize the restrictions based on which services have been associated with past fraud and abuse.

Furthermore, the preamble expresses the agency’s view that orthotic and prosthetic services are equivalent to DME. CMS states that “we believe items of [prosthetics, orthotics, and supplies] require the same level of medical intervention and skill as DME.” Obviously, many orthotists and prosthetists believe that orthotic and prosthetic care requires far greater skill and training than DME and would, therefore, disagree with this statement.

Face-to-Face Visits. The most significant change to the regulations is the proposed requirement for a face-to-face visit with a physician, physician assistant (PA), clinical nurse specialist (CNS), or nurse practitioner (NP). (Note: This language would prohibit a physical therapist from prescribing DMEPOS, but not necessarily from providing orthotic and prosthetic services.) Currently, an orthotist or prosthetist may furnish an item to a beneficiary based on a physician’s written order, regardless of whether the beneficiary has recently had a face-to-face visit with a physician.

For example, currently, if a patient needs to replace a lower limb prosthesis, the prosthetist can communicate with the treating physician, request a written prescription, and then furnish the new prosthesis. Under the proposed regulations, the patient would have to first have a face-to-face visit with a physician, PA, CNS, or NP. While this is consistent with current practice in many instances, the proposed regulation may lead to a delay in some patients’ treatment.

Furthermore, the preamble states that “the face-to-face examination should be for the purpose of evaluating and treating the patient’s medical condition and not for the sole purpose of obtaining the prescribing physician’s or practitioner’s order for the DMEPOS.” The text of the proposed regulation states that Medicare will not pay for a face-to-face examination that is solely for the beneficiary to obtain a prescription.

How these statements apply to orthotic and prosthetic care is unclear. For example, if a patient needs a new upper limb prosthesis, the preamble to the regulation indicates that the patient must go to the physician so that the physician can evaluate and treat the patient’s medical condition, not solely so that the physician can prescribe a new artificial limb. Exactly what the physician is expected to do, in addition to prescribing the limb, is unclear. What is clear is that Medicare will not reimburse the physician for his time if the visit is solely so that the patient can obtain a prescription for a new prosthesis. This is obviously a major potential problem for the orthotics and prosthetics field.

Order Required Before Delivery. Currently, most items of DMEPOS may be delivered based on a verbal physician order. Only seven types of DME items currently require a written order prior to delivery: pressure reducing pads; mattress overlays; mattresses; beds; seat lift mechanisms; TENS units; and power operated vehicles. All DMEPOS items, however, require a written physician order prior to the supplier billing Medicare.

Under the proposed regulations, a supplier must have a signed written order prior to delivery of any DMEPOS item. While this will be a major problem for the DME field, it may be less of an issue for orthotists and prosthetists. Nevertheless, this is a change from the current documentation requirements, and the orthotics and prosthetics field will need to analyze this change’s effects and comment to CMS, if necessary.

Order Must Be Signed Within 30 Days of Visit. The proposed rule will also require that the physician’s written order is signed and dated within thirty days of the face-to-face visit. While in the past there have been time limits requiring delivery within thirty days of the written order, there has not been a requirement that the written order must be within thirty days of a face-to-face physician visit.

This requirement ignores the unique clinical circumstances surrounding orthotic and prosthetic care. For example, with respect to highly complex prostheses, it may take a number of patient visits before a prosthetist determines exactly what prosthetic components are appropriate. The written order should be sufficiently detailed to reflect each component for which the prosthetist bills Medicare. Often, thirty days from the patient’s visit with the physician will represent a very small window for the prosthetist to finalize the prosthesis design and obtain a sufficiently detailed written physician order.

Commenting on the Rule. CMS is accepting comments on the proposed rule through September 24, 2004. The preamble and text of the proposed rule can be found at It is of critical importance that orthotists, prosthetists, and others who are concerned with this proposal express their concerns to CMS (electronic comments can be submitted at and should refer to CMS-1429-P). As part of this effort, the National Association for the Advancement of Orthotics and Prosthetics (NAAOP) will be submitting comments to CMS on these important issues.

Also, a more in-depth discussion of these and other Medicare documentation requirements will be included at the Third Annual Meeting: Protecting & Expanding Your Practice, to be held in Las Vegas on November 19th and 20th.

Adam H. Greene is a health care attorney with Powers Pyles Sutter & Verville, P.C. and frequently works with the National Association for the Advancement of Orthotics and Prosthetics. You may contact Mr. Greene at (202) 466-6550.

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