Prior Authorization for Medicare O&P Services: An Update

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By Peter W. Thomas, JD, and Christina Hughes, JD, MPH

The Centers for Medicare & Medicaid Services (CMS) proposed a rule on May 28 that would require suppliers of certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) to submit a prior authorization request to CMS or its contractors before furnishing the DMEPOS item. It is likely that CMS will also apply the concept of prior authorization to lowerlimb prosthetics.

According to the proposed rule, if CMS or its contractors conclude that the prior authorization request adheres to all applicable Medicare coverage, coding, and payment rules, the supplier will receive a provisional affirmation. If CMS or its contractors deny the prior authorization request, the supplier may not appeal the determination, but may resubmit the prior authorization request multiple times. If the supplier proceeds to submit a claim for Medicare payment without first receiving a nonaffirmed prior authorization decision, the claim will be denied and an appeal can be pursued.

During the two-month period when public comments were being developed by the O&P profession, it became clear that many individuals in the profession believe that prior authorization is preferable to a world where postpayment audits leave orthotists and prosthetists holding the bag. But there are real concerns with the rule as currently proposed by CMS. The reality is that prior authorization will likely be applied to certain aspects of O&P care as a result of this rule and could be detrimental to patient care and the O&P professional's ability to treat patients. The National Association for the Advancement of Orthotics and Prosthetics (NAAOP) and other national associations are working to get the best final rule possible and on July 24 submitted comments about the proposal on behalf of the O&P Alliance. This article discusses some of the areas of most concern to the O&P profession that were addressed in the comments.

Applying Durable Medical Equipment Standards to O&P

Our concerns about prior authorization stem from CMS' tendency to apply durable medical equipment (DME) solutions to O&P patient care. Prior authorization started with Medicare coverage of power wheelchairs, and CMS is proposing to apply the same process to lower-limb prostheses, which it says has been established by government reports as an area of overutilization. To welcome prior authorization as proposed will essentially accept CMS' viewpoint—which most O&P professionals would find objectionable.

Many in the O&P profession do not believe that the proposed prior authorization process is a good fit for O&P due to the clinical nature of custom O&P patient care. A practitioner does not merely accept a physician's order for a prosthetic limb and select one off the shelf for the beneficiary to use. The O&P professional's intimate involvement in the process of assessing each patient's medical and functional needs; recommending a treatment plan in conjunction with physicians and therapists; and selecting, designing, fabricating, and fitting a prosthesis requires a level of clinical interaction and expertise that goes far beyond what is contemplated by the proposed rule.

Furthermore, the treatment plan may change during the course of fitting, such as when a patient rejects a particular prosthetic foot or knee joint and one with different functions must be used as an alternative. For example, a particular prosthetic foot may be too heavy or provide too much rotation, causing instability in the patient's gait. These elements of O&P patient care would significantly complicate the process of obtaining prior authorization for that care.

The prior authorization process as outlined by CMS will likely result in delayed clinical treatment to Medicare beneficiaries, jeopardizing patients' access to timely and appropriate care. Second-guessing and delaying critical patient care by requiring prior authorization may have unintended consequences that could be avoided through the use of alternative methods for overseeing the provision of O&P care. The prior authorization process could easily take weeks, and during this time, patients would not receive the lower-limb prosthetic care they legitimately need to achieve or maintain ambulation with reasonable comfort and to return to normal daily activities.

For these reasons, this process has the potential to significantly compromise patient care. For an ambulatory patient, the delay in treatment may force him or her to endure unnecessary pain, as in the case of an ill-fitting prosthesis that needs replacement, while CMS renders a decision. Worse yet, such a delay could significantly compromise the long-term functional potential of nonambulatory individuals with limb loss, while paperwork is secured regarding the medical necessity of the care needed by the patient. For a patient awaiting his or her first prosthesis post-amputation, this delay may contribute to continued loss of motor function and capability as the patient remains largely immobile while CMS contractors deliberate on the sufficiency of the documentation. Prosthetics involves a lifetime clinical patient care relationship; it is not the delivery of DME commodities.

An Alternative Method to Control O&P Utilization Exists

Congress has already created statutory requirements that CMS could use to control utilization of O&P items and services. Of overriding significance is the requirement in the Medicare, Medicaid, and SCHIP (State Children's Health Insurance Program) Benefits Improvement and Protection Act of 2000 (BIPA) that a "qualified practitioner" or "qualified supplier" must provide the designated O&P service or device in order to be eligible to receive reimbursement by Medicare. CMS has never fully implemented this existing federal law. If it were finally to do so, this law would dramatically reduce the need to impose DME-based solutions to address perceived utilization problems for O&P.

Linking the ability to receive Medicare payment for custom orthoses and prostheses to the qualifications of the practitioner or supplier providing the O&P care would significantly advance accountability and quality in this area while reducing inappropriate utilization and any fraud and abuse that may be occurring. Currently, the DME Medicare Administrative Contractor (DME MAC) claims processing system does not contain sufficient "edits" to ensure that billing for custom O&P services and devices is limited to appropriately licensed, certified, accredited, or otherwise qualified O&P practitioners and suppliers.

As a result of CMS' failure to implement §427 of BIPA, once a supplier has been granted Medicare DMEPOS billing privileges, it is largely free to submit claims for any type of DMEPOS service, including many of those for which it is not appropriately licensed or certified. This, in turn, contributes to the alleged questionable billing practices of providers of O&P services. To reduce the incidence of overpayments, CMS should implement and enforce BIPA as a necessary step to curtailing overpayments for custom orthoses and prostheses from unqualified providers and suppliers. If this were to occur, CMS would not need to impose a prior authorization requirement on O&P practitioners and suppliers that will likely delay and potentially compromise patient care.

Implementation of Prior Authorization

Prior Authorization Must Be Binding

If prior authorization is applied to O&P patient care, it should mean that once the prior authorization is approved, CMS and all of its contractors, including Recovery Audit Contractors (RACs), should be prevented from questioning the medical necessity of the claim. This is an important protection for the O&P profession for which NAAOP and the O&P Alliance are fighting.

Through the submitted comments, NAAOP and the O&P Alliance sought assurance from CMS that the DME MACs and all other Medicare contractors will be barred from further review of any such claim for purposes of determining medical necessity once the provisional prior authorization is granted, absent credible allegations of fraud. (Author's note: The only possible exception to this prohibition on secondary review is the Comprehensive Error Rate Testing (CERT) auditor, given its responsibility for assessing the accuracy of the DME MACs' performance.) The DME MACs and other contractors should only be permitted to examine a prior authorized claim—pre- or post-payment—to determine if there are technical deficiencies related to proper proof of delivery, whether the claim is duplicative, and whether the beneficiary died after CMS or its contractors approved the prior authorization request. This is a critical safeguard for the O&P profession that CMS should specifically adopt in the final rule.

O&P Professionals' Documentation Must Be Considered

Significant questions exist as to the documents that will be required for a CMS contractor to approve a prior authorization request. If it requires extensive physician documentation and ignores the prosthetist's clinical notes, it would be a major problem that would delay, and ultimately deny, patient care. In the proposed rule, however, CMS does not set forth the standards that will apply to issuing or withholding prior authorization. Presumably, CMS intends to defer to the contractors who oversee the claim submission and reimbursement process for O&P items and services, the DME MACs.

Unfortunately, the DME MACs have set forth policies in their Local Coverage Determinations (LCDs) regarding lower-limb prostheses that eliminate the consideration of an O&P professional's clinical notes and assessments in determining the medical necessity of such O&P items and services. Specifically, the DME MACs' LCDs indicate that "supplier-produced records" are not considered to be part of the medical record. For examples of these policies, refer to LCD L-11464 (NHIC) and the "Dear Physician" letter dated August 2011 regarding "Documentation of Artificial Limbs." As each O&P professional is classified as a "supplier," whether operating independently or as part of a group, the LCDs effectively prevent any notes or assessments generated by the certified prosthetist who provides direct care to a patient with an amputation from being considered in the medical necessity decision-making process. Instead, the DME MACs rely entirely and exclusively on documentation generated by the treating physician.

However, justifying payment to a prosthetist based solely on the quality and content of the prescribing physician's medical records is not reasonable. The prosthetist's clinical notes are critical to the medical necessity determination and should be explicitly considered part of the medical record. CMS will do the prosthetic patient a grave disservice if it denies coverage and payment of prosthetic care needed to restore mobility based on inadequate physician documentation alone. The qualified prosthetist represents the healthcare professional with specialized prosthetic education, clinical training, and experience, who has historically been relied upon to recommend appropriate prosthetic designs for individual patient needs.

CMS' expectation that a treating physician's notes alone should be so specific as to independently justify medical necessity is highly questionable. Worse yet, the complete exclusion of the O&P professional's notes from such consideration is far more concerning. Not to consider the prosthetist's notes as a relevant component of establishing medical necessity flies in the face of logic, the Medicare statute, Congressional intent, and historical precedent. Therefore, it is critical that this documentation issue be clarified by CMS in any final regulation.

Timeframes for Decisions Must be Established

Considering the important patient care implications such delays may have, the standard timeframes (i.e., ten days for an initial decision and 20 days for a decision on a resubmitted request) that CMS proposes for issuing a prior authorization decision are too long. Simply compiling the documentation in preparation for submission of a prior authorization request will take days, if not weeks. Once the documentation is submitted, the CMS contractor should be required to act expeditiously in order to avoid further patient care delays (i.e., within five business days). This timeframe would commence when the contractor receives the request for prior authorization and end when the contractor delivers its provisional authorization or denial to the supplier at the supplier's contact location.

For resubmitted requests for prior authorization, the timeframe for issuing a provisional decision should also be five business days. It is unclear why a longer timeframe for issuing a decision is required when a resubmission is made, as it should be treated in the same manner as an initial request. The extended timeframe appears to be punitive in nature and is not appropriate when patient care is being delayed.

In addition, because any timeframe for issuing a prior authorization decision will commence when the contractor receives the request, processes must be in place that allow for the immediate submission of the request and all supporting documentation. It is not appropriate to allow the contractors to require all submissions be directed to post office boxes, as they traditionally do with appeal correspondence. Instead, implementation of any prior authorization requirement should be delayed until systems are in place to allow for the secure electronic submission of requests and supporting documentation or for the submission of such materials via facsimile.

Furthermore, it is critical that CMS contractors be required to adhere to the timeframes and procedures established under any final prior authorization rules. To ensure compliance, the submitted comments recommended that a contractor's failure to provide a timely response to a prior authorization request should be considered as a provisional prior authorization, permitting the O&P supplier to proceed with rendering patient care. In addition, every denial should address the specific patient at issue and supply a sufficient rationale as to the reason for the denial. CMS contractors should be strictly precluded from issuing any pro forma denials simply for their convenience, or blanket denials, which essentially function as a mechanism to "restart the clock."

Under the proposed rule, expedited review is warranted if CMS or its contractors agree that the standard timeframe for rendering a decision may "seriously jeopardize the life or health of the beneficiary or the beneficiary's ability to regain maximum function." However, the preamble of the proposed rule does not discuss when the beneficiary's ability to regain maximum function warrants the expedited review process. Examples of when expedited review should be required include the following:

  • All patients awaiting the provision of their first post-amputation prosthetic limb.
  • Any patient whose prosthesis is no longer usable and, as a result, the patient is not able to functionally ambulate until a new limb is provided.
  • In instances where a plan of care has received prior authorization but, for whatever reason, the patient's plan of care changes during the fabrication and fitting processes.

Finally, the expedited timeframe (i.e., two days) should also apply to any resubmissions required for items and services that qualified originally for such review.

Conclusion

CMS has plenty of options to limit overutilization—other than through prior authorization. NAAOP and its O&P Alliance partners have been pressing CMS to implement federal law that links the right to bill Medicare for custom orthotics and prosthetics with O&P licensure and accreditation. We have been asking CMS to treat O&P separately from DME for years. We have been demanding that CMS recognize the clinical notes of the prosthetist/orthotist as part of the medical record when determining the medical necessity of O&P patient care. That said, there are a number of important recommendations to the proposed rule that could dramatically improve the prior authorization process if CMS insists on applying it to O&P. Hopefully, CMS will take these recommendations into account in any final prior authorization regulations it issues that affect O&P care.

Peter W. Thomas, JD, is general counsel for the National Association for the Advancement of Orthotics and Prosthetics (NAAOP). Christina A. Hughes, JD, MPH, is an associate with Powers Pyles Sutter & Verville, Washington DC.